WO2023071378A1 - Implantable nerve stimulator and implantable nerve stimulation system - Google Patents

Implantable nerve stimulator and implantable nerve stimulation system Download PDF

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WO2023071378A1
WO2023071378A1 PCT/CN2022/110913 CN2022110913W WO2023071378A1 WO 2023071378 A1 WO2023071378 A1 WO 2023071378A1 CN 2022110913 W CN2022110913 W CN 2022110913W WO 2023071378 A1 WO2023071378 A1 WO 2023071378A1
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real
patient
time
electrodes
electrode combination
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PCT/CN2022/110913
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French (fr)
Chinese (zh)
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周国新
唐建东
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苏州景昱医疗器械有限公司
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    • 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
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • 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
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36053Implantable neurostimulators for stimulating central or peripheral nerve system adapted for vagal stimulation
    • 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
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • 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
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36062Spinal stimulation
    • 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
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36067Movement disorders, e.g. tremor or Parkinson disease
    • 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
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36082Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
    • A61N1/36089Addiction or withdrawal from substance abuse such as alcohol or drugs
    • 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
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36082Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
    • A61N1/36096Mood disorders, e.g. depression, anxiety or panic disorder
    • 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
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36125Details of circuitry or electric components
    • 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
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128Control systems
    • A61N1/36132Control systems using patient feedback

Definitions

  • the present application relates to the technical field of implantable neurostimulators, in particular to implanted neurostimulators and implanted neurostimulator systems.
  • Implantable neurostimulation systems mainly include stimulators implanted in the body, electrodes and program-controlled equipment outside the body.
  • the existing neuromodulation technology mainly uses stereotaxic surgery to implant electrodes in specific structures (i.e., targets) in the body, and the stimulator implanted in the patient sends electrical pulses to the targets through the electrodes to regulate the corresponding neural structures and networks. Electrical activity and its function, thereby improving symptoms and relieving pain.
  • the patient After receiving neuromodulation by doctors in the hospital, the patient needs to fine-tune the parameters of the stimulator in the patient's body as the environment changes or changes in his own state after returning home, such as changes in his own state caused by taking medicine, exercising, sleeping and other behaviors. achieve the best stimulating effect.
  • the existing parameter adjustment method is to set a stimulation parameter range by the doctor and adjust it by the patient himself.
  • This adjustment method is a passive and very inaccurate adjustment method, and the actual effect is not ideal.
  • Chinese invention patent CN113244533A discloses a parameter adjustment method, device, electronic equipment, and computer-readable storage medium. The method includes: using a program-controlled device installed outside the patient's body to receive a marking operation, and using a stimulator to collect the brain of the patient in response to the marking operation.
  • Electric signal associate and store the patient's EEG signal and state type into the first data set; use the first data set to train the first deep learning model to obtain a state classification model; use the stimulator to collect the patient's real-time EEG signal; convert the real-time The EEG signal is input to the state classification model to obtain the real-time state type corresponding to the real-time EEG signal; obtain the parameter configuration information corresponding to the real-time state type; use the program-controlled equipment to adjust the parameters of the stimulator so that the stimulator can apply corresponding electrical stimulation to the patient.
  • the method can apply timely and accurate electrical stimulation to the patient, and the stimulation effect is good.
  • the purpose of this application is to provide an implantable neurostimulator and an implanted neurostimulation system, which solves the problem that the implanted neurostimulation system has a large amount of computation when adjusting parameters in the prior art, takes up valuable computing resources, and reduces the The problem of the running speed of the processes corresponding to the remaining functions of the implantable neurostimulation system.
  • the present application provides a method for adjusting parameters of an implantable neurostimulator, which is applied to an implanted neurostimulator, and the implanted neurostimulator includes: a plurality of electrodes, and the plurality of electrodes can be positioned within the brain of a patient to deliver therapy to the patient or to sense electrical activity; therapy delivery circuitry operably coupled to the plurality of electrodes to deliver therapy to the patient; sensing circuitry, the sensing circuit is operatively coupled to the plurality of electrodes to sense electrical activity; a controller comprising a processing circuit operably coupled to the therapy delivery circuit and the sensing circuit
  • the method includes: through the sensing circuit, real-time sensing the potential of two electrodes corresponding to the recommended electrode combination, the recommended electrode combination includes two of the plurality of electrodes, based on the potential of the recommended electrode combination corresponding to the potentials of the two electrodes, and calculate the real-time voltage between the two electrodes corresponding to the recommended electrode combination; based on the real-time voltage between the
  • the beneficial effect of this technical solution is that the potential of the electrode corresponding to the recommended electrode combination is used to obtain the voltage between the two electrodes, and then the real-time characteristic signal is obtained according to the voltage, and the similarity between the real-time characteristic signal and the previous moment is detected, only When the similarity is not greater than the preset similarity (meaning that the real-time characteristic signal at the current moment is different from the real-time characteristic signal at the previous moment), the real-time characteristic signal at the current moment will be classified to obtain the real-time state type, and according to the The real-time state type obtains parameter configuration information to control the electrode to deliver treatment to the patient; compared with the real-time state type, the real-time obtainment of similarity requires less calculation, saves computing resources, and improves the performance of other functions of the implantable neurostimulation system. The running speed of the corresponding process.
  • the method further includes: sensing the potentials of the plurality of electrodes through the sensing circuit; calculating any two of the potentials based on the sensed potentials of the plurality of electrodes The difference between the potentials of the electrodes is used to obtain the voltage between any two electrodes; based on the voltage between any two electrodes within a preset time range, the corresponding electrode combination formed by the two electrodes is obtained.
  • Characteristic signal Based on one or more of the signal strength, pulse width and similarity between the characteristic signal and the expected signal of the characteristic signal corresponding to each electrode combination, obtain the score corresponding to each electrode combination; based on all electrode combinations Corresponding to the score, the electrode combination with the highest score is used as the recommended electrode combination.
  • the beneficial effect of this technical solution is to provide a method for obtaining recommended electrode combinations, based on the voltage between any two electrodes within a preset time range, to obtain a characteristic signal, and then based on one or more of a plurality of characteristic signals Scores are calculated for features, and the one with the highest score is used as the recommended electrode combination.
  • the obtained recommended electrode combination can reflect the real state of the patient to the greatest extent, making the parameter adjustment based on the recommended electrode combination more accurate.
  • the acquiring parameter configuration information based on the real-time state type of the patient includes: inputting the real-time state type of the patient into a parameter configuration model to obtain parameter configuration information corresponding to the real-time state type , the parameter configuration model is pre-trained; or the real-time state type of the patient is sent to the program-controlled device, so that the program-controlled device sends the real-time state type to the user equipment corresponding to the patient, and receives the The parameter configuration information sent by the program-controlled device, the parameter configuration information is obtained through manual configuration.
  • the beneficial effect of this technical solution is that, using the parameter configuration model to obtain parameter configuration information based on real-time state types can quickly and automatically obtain parameter configuration information, respond to changes in patient status in a timely manner, and improve the effect of delivering treatment to patients; or, using Manual configuration obtains parameter configuration information based on real-time status types, and the obtained parameter configuration information is accurate, and can flexibly adjust parameters for specific patients, which helps to improve treatment effects.
  • the acquisition of the user equipment corresponding to the patient includes the following steps: based on the real-time status type of the patient, querying the real-time communication level corresponding to the real-time status type, wherein, for the patient , each communication level corresponds to one or more user equipment, and the user equipment corresponding to each communication level is manually configured, and the real-time communication level is one of the communication levels; obtain the patient's corresponding User equipment at said real-time communication level.
  • the beneficial effect of this technical solution is that, based on the real-time state type, the real-time communication level corresponding to the state type is determined, and the user equipment corresponding to the patient is obtained based on the real-time communication level, and different user equipment can be obtained for different real-time state types of the patient. , so that when the patient is in a different state, the corresponding personnel can know the state of the patient in time.
  • the controlling one or more of the plurality of electrodes to deliver therapy to the patient through the therapy delivery circuit based on the parameter configuration information includes: based on the parameter configuration information, and through the therapy delivery circuit, control the two electrodes corresponding to the recommended electrode combination to deliver therapy to the patient.
  • the beneficial effect of this technical solution is that the treatment is delivered based on the electrodes corresponding to the recommended electrode combination based on the parameter configuration information. Since the parameter configuration information is obtained based on the recommended electrode combination, it will be more accurate to deliver treatment based on the electrodes corresponding to the recommended electrode combination .
  • the method further includes: when the similarity between the real-time characteristic signal at the current moment corresponding to the recommended electrode combination and the real-time characteristic signal at the previous moment is not greater than the preset similarity, It is determined that the patient has a state change, and the real-time characteristic signal at the current moment corresponding to the recommended electrode combination is recorded.
  • the beneficial effect of this technical solution is that using the similarity to determine the change of the patient's state and recording the current moment and its corresponding real-time characteristic signal can make the change of the patient's state and the corresponding real-time characteristic signal traceable, and help medical staff to Patient status for follow-up visits and/or research.
  • the method further includes: sending the real-time status type of the patient to a program-controlled device, so that the program-controlled device sends a message containing the real-time status type to the user equipment corresponding to the patient.
  • State change prompt information use the program-controlled device to receive the confirmation operation or modification operation on the real-time state type sent by the user equipment corresponding to the patient, confirm or modify the real-time state type, and then compare the real-time state type and The real-time characteristic signal corresponding to the recommended electrode combination is associated and stored as training data for updating the state classification model.
  • the beneficial effect of the technical solution is that the state change prompt information is sent to the user equipment, and the confirmation or modification operation of the user is received, and the confirmed or modified real-time state type and the real-time characteristic signal are associated and stored to update the state classification model,
  • the recognition accuracy of the state classification model can be further optimized by manually confirming and modifying the real-time state classification, thereby finally improving the accuracy of parameter adjustment.
  • the method further includes: controlling one or more of the plurality of electrodes to deliver therapy to the patient through the therapy delivery circuit;
  • the sensing circuit senses the potentials of the plurality of electrodes.
  • sensing the potential of multiple electrodes can reflect the change of the patient's state during the treatment process, and the parameter adjustment can reflect the impact of the treatment on the patient's state, which is convenient for medical treatment. Personnel adjustment and research.
  • the present application provides an implantable neurostimulator, comprising: a plurality of electrodes capable of being positioned in the brain of a patient to deliver therapy or sense electrical activity to the patient; a therapy delivery circuit, the therapy delivery circuit operably coupled to the plurality of electrodes to deliver therapy to the patient; a sensing circuit operatively coupled to the plurality of electrodes to sense electrical activity; a controller comprising processing circuitry operatively coupled to the therapy delivery circuit and the sensing circuit, the controller configured to sense, in real time, a recommended electrode via the sensing circuit Combine the potentials of the corresponding two electrodes, the recommended electrode combination includes two of the plurality of electrodes, and calculate the two electrodes corresponding to the recommended electrode combination based on the potentials of the two electrodes corresponding to the recommended electrode combination based on the real-time voltage between the two electrodes corresponding to the recommended electrode combination from the preset moment to the current moment, obtain the real-time characteristic signal corresponding to the recommended electrode combination at the current moment, the preset The time is before the
  • the controller is further configured to obtain the recommended electrode combination in the following manner: through the sensing circuit, sensing the potentials of the plurality of electrodes; The potentials of the plurality of electrodes are calculated, and the difference between the potentials of any two electrodes is calculated to obtain the voltage between the two electrodes; based on the voltage between the two electrodes within the preset time range, the obtained The characteristic signal corresponding to the electrode combination formed by any two electrodes; based on one or more of the signal strength, pulse width and similarity between the characteristic signal and the expected signal of the characteristic signal corresponding to each electrode combination, obtain The score corresponding to each electrode combination; based on the scores corresponding to all electrode combinations, the electrode combination with the highest score is used as the recommended electrode combination.
  • the controller is further configured to obtain the parameter configuration information in the following manner: input the real-time state type of the patient into the parameter configuration model to obtain the parameter configuration corresponding to the real-time state type information, the parameter configuration model is pre-trained; or
  • the controller is further configured to obtain the user equipment corresponding to the patient in the following manner: based on the real-time status type of the patient, query the real-time communication level corresponding to the real-time status type , wherein, for the patient, each communication level corresponds to one or more user equipment, and the user equipment corresponding to each communication level is manually configured, and the real-time communication level is one of the communication levels ; Obtain the user equipment corresponding to the patient at the real-time communication level.
  • the controller is further configured to deliver treatment to the patient in the following manner: based on the parameter configuration information, through the treatment delivery circuit, control the two electrodes corresponding to the recommended electrode combination electrodes to deliver therapy to the patient.
  • the controller is further configured to: when the similarity between the real-time characteristic signal at the current moment and the real-time characteristic signal at the previous moment corresponding to the recommended electrode combination is not greater than the preset similarity When the degree is higher, it is determined that the patient has a state change, and the real-time characteristic signal at the current moment corresponding to the recommended electrode combination is recorded.
  • the controller is further configured to: send the real-time status type of the patient to the program-controlled device, so that the program-controlled device sends the real-time State change prompt information of the state type; use the program-controlled device to receive the confirmation operation or modification operation for the real-time state type sent by the user equipment corresponding to the patient, confirm or modify the real-time state type, and then update the real-time state type
  • the state type and the real-time characteristic signal corresponding to the recommended electrode combination are associated and stored as training data for updating the state classification model.
  • the controller is further configured to: control one or more of the plurality of electrodes to deliver therapy to the patient through the therapy delivery circuit; , sensing potentials of the plurality of electrodes through the sensing circuit.
  • the present application provides an implantable neurostimulator system, including a program-controlled device and any one of the above-mentioned implanted neurostimulators.
  • the program-controlled device is provided with a touch display screen.
  • the touch screen can facilitate the operation of the program-controlled equipment by the patient.
  • Fig. 1 is a brief flow diagram of a parameter adjustment method in the prior art
  • FIG. 2 is a schematic flowchart of a parameter adjustment method provided in the embodiment of the present application.
  • FIG. 3 is a schematic flowchart of a parameter adjustment method provided in an embodiment of the present application.
  • Fig. 4 is a partial flowchart of another parameter adjustment method provided by the embodiment of the present application.
  • FIG. 5 is a schematic flow diagram of obtaining parameter configuration information provided by an embodiment of the present application.
  • FIG. 6 is a schematic flow diagram of obtaining a user equipment corresponding to a patient provided by an embodiment of the present application.
  • Fig. 7 is a partial flowchart of another parameter adjustment method provided by the embodiment of the present application.
  • FIG. 8 is a partial flowchart of another parameter adjustment method provided by the embodiment of the present application.
  • FIG. 9 is a partial flowchart of another parameter adjustment method provided by the embodiment of the present application.
  • Fig. 10 is a schematic structural diagram of an implantable neurostimulator provided in an embodiment of the present application.
  • Fig. 11 is a schematic structural diagram of an electronic device provided by an embodiment of the present application.
  • FIG. 12 is a schematic structural diagram of a program product for implementing a parameter adjustment method provided by an embodiment of the present application.
  • At least one means one or more, and “multiple” means two or more.
  • “And/or” describes the association relationship of associated objects, indicating that there may be three types of relationships, for example, A and/or B, which can mean: A exists alone, A and B exist simultaneously, and B exists alone, where A, B can be singular or plural.
  • the character “/” generally indicates that the contextual objects are an “or” relationship.
  • “At least one of the following” or similar expressions refer to any combination of these items, including any combination of single or plural items.
  • At least one item (piece) of a, b or c can represent: a, b, c, a and b, a and c, b and c or a and b and c, wherein a, b and c can be It can be single or multiple. It should be noted that "at least one item (item)” can also be interpreted as “one item (item) or multiple items (item)”.
  • words such as “exemplary” or “for example” are used to mean an example, illustration or description. Any embodiment or design described herein as “exemplary” or “for example” is not to be construed as preferred or advantageous over other embodiments or designs. Rather, the use of words such as “exemplary” or “such as” is intended to present related concepts in a concrete manner.
  • An implantable neurostimulator system (an implanted medical system) mainly includes a stimulator implanted in a patient (ie, an implanted neurostimulator) and a program-controlled device placed outside the patient's body.
  • the existing neuromodulation technology mainly uses stereotaxic surgery to implant electrodes in specific structures (i.e., targets) in the body, and the stimulator implanted in the patient sends electrical pulses to the targets through the electrodes to regulate the corresponding neural structures and networks. Electrical activity and its function, thereby improving symptoms and relieving pain.
  • the stimulator can be an implantable electrical nerve stimulation device, an implantable cardiac electrical stimulation system (also known as a cardiac pacemaker), an implantable drug infusion device (Implantable Drug Delivery System, referred to as IDDS) and a wire switch. Any one of the connected devices.
  • Implantable electrical nerve stimulation devices are, for example, Deep Brain Stimulation (DBS), Implantable Cortical Nerve Stimulation (CNS), Implantable Spinal Cord Stimulation , referred to as SCS), implanted sacral nerve stimulation system (Sacral Nerve Stimulation, referred to as SNS), implanted vagus nerve stimulation system (Vagus Nerve Stimulation, referred to as VNS) and so on.
  • DBS Deep Brain Stimulation
  • CNS Implantable Cortical Nerve Stimulation
  • SCS Implantable Spinal Cord Stimulation
  • SNS implanted sacral nerve stimulation system
  • Vagus Nerve Stimulation referred to as VNS
  • VNS vagus Nerve Stimulation
  • the stimulator can include IPG, extension wires and electrode wires.
  • the IPG implantable pulse generator, implantable pulse generator
  • the IPG is set in the patient's body, receives the program control instructions sent by the program control device, and provides controllable stimulation to the tissues in the body relying on sealed batteries and circuits.
  • Electrical stimulation energy through implanted extension leads and electrode leads, delivers one or two controlled, specific electrical stimuli to specific areas of tissue in the body.
  • the extension lead is used in conjunction with the IPG as a transmission medium for the electrical stimulation signal, and transmits the electrical stimulation signal generated by the IPG to the electrode lead.
  • Electrode leads deliver electrical stimulation to specific areas of tissue in the body through multiple electrode contacts.
  • the stimulator is provided with one or more electrode wires on one side or both sides, and a plurality of electrode contacts are arranged on the electrode wires, and the electrode contacts can be arranged uniformly or non-uniformly in the circumferential direction of the electrode wires.
  • the electrode contacts may be arranged in an array of 4 rows and 3 columns (a total of 12 electrode contacts) in the circumferential direction of the electrode wire.
  • Electrode contacts may include stimulation electrode contacts and/or collection electrode contacts.
  • the electrode contacts can be in the shape of, for example, a sheet, a ring, or a dot.
  • 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 site is generally different, the number of stimulation contacts used (single source or multi-source), one or more channels (single-channel or multi-channel) specific electrical stimulation signals
  • the application and stimulus parameter data are also different.
  • the embodiment of the present application does not limit the applicable disease types, which may be the applicable disease types for deep brain stimulation (DBS), spinal cord stimulation (SCS), pelvic stimulation, gastric stimulation, peripheral nerve stimulation, and functional electrical stimulation.
  • DBS disorders that DBS can be used to treat or manage include, but are not limited to: spasticity disorders (e.g., epilepsy), pain, migraine, psychiatric disorders (e.g., major depressive disorder (MDD)), bipolar disorder, anxiety disorders, Post-traumatic stress disorder, hypodepression, obsessive-compulsive disorder (OCD), conduct disorder, mood disorder, memory disorder, mental status disorder, mobility disorder (eg, essential tremor or Parkinson's disease), Huntington's disease, Al Alzheimer's disease, drug addiction, autism, or other neurological or psychiatric conditions and impairments.
  • spasticity disorders e.g., epilepsy
  • pain migraine
  • psychiatric disorders e.g., major depressive disorder (MDD)
  • bipolar disorder e.g., anxiety disorders, Post-traumatic stress disorder, hypodepression, obsessive-compulsive disorder (OCD)
  • OCD obsessive-compulsive disorder
  • conduct disorder mood disorder
  • the program-controlled device when the program-controlled device and the stimulator establish a program-controlled connection, can be used to adjust the stimulation parameters of the stimulator (different stimulation parameters correspond to different electrical stimulation signals), and the stimulator can also be used to sense the deep brain of the patient.
  • the bioelectric activity of the stimulator can be used to collect the electrophysiological signal, and the stimulation parameters of the electrical stimulation signal of the stimulator can be adjusted continuously through the collected electrophysiological signal.
  • Stimulation parameters can include at least one of the following: frequency (for example, the number of electrical stimulation pulse signals per unit time 1s, the unit is Hz), pulse width (the duration of each pulse, the unit is ⁇ s), amplitude (generally used Voltage expression, that is, the intensity of each pulse, the unit is V), timing (for example, it can be continuous or triggered), stimulation mode (including one or more of current mode, voltage mode, timed stimulation mode and cycle stimulation mode) , The upper and lower limits of the doctor's control (the range that can be adjusted by the doctor) and the upper and lower limits of the patient's control (the range that can be adjusted by the patient).
  • frequency for example, the number of electrical stimulation pulse signals per unit time 1s, the unit is Hz
  • pulse width the duration of each pulse, the unit is ⁇ s
  • amplitude generally used Voltage expression, that is, the intensity of each pulse, the unit is V
  • timing for example, it can be continuous or triggered
  • stimulation mode including one or more of current mode, voltage mode, time
  • various stimulation parameters of the stimulator can be adjusted in current mode or voltage mode.
  • the program-controlled device may be a doctor-programmed device (ie, a program-controlled device used by a doctor) or a patient-programmed device (ie, a program-controlled device used by a patient).
  • the doctor's program-controlled device can be, for example, a tablet computer, a notebook computer, a desktop computer, a mobile phone and other smart terminal devices equipped with program-controlled software.
  • the patient program-controlled device can be, for example, smart terminal devices such as tablet computers, notebook computers, desktop computers, and mobile phones equipped with program-controlled software, and the patient program-controlled device can also be other electronic devices with program-controlled functions (such as chargers with program-controlled functions, data collection device).
  • the embodiment of the present application does not limit the data interaction between the doctor's program-controlled device and the stimulator.
  • the doctor's program-controlled device can perform data interaction with the stimulator through the server and the patient's program-controlled device.
  • the doctor performs program control with the patient face-to-face offline the doctor's program-controlled device can interact with the stimulator through the patient's program-controlled device, and the doctor's program-controlled device can also directly interact with the stimulator.
  • the patient programmable device may include a host (communicating with the server) and a slave (communicating with the stimulator), the host and slave being communicatively connected.
  • the doctor's program-controlled equipment can exchange data with the server through the 3G/4G/5G network
  • the server can exchange data with the host through the 3G/4G/5G network
  • the host can exchange data with the slave through the Bluetooth protocol/WIFI protocol/USB protocol.
  • the sub-machine can exchange data with the stimulator through the 401MHz-406MHz working frequency band/2.4GHz-2.48GHz working frequency band, and the doctor's program-controlled equipment can directly exchange data with the stimulator through the 401MHz-406MHz working frequency band/2.4GHz-2.48GHz working frequency band interact.
  • FIG. 1 is a schematic flowchart of a parameter adjustment method in the prior art. Among them, the change of the patient’s state type is judged based on obtaining the real-time state type of the patient in real time and judging whether the real-time state type has changed. larger.
  • FIG. 2 is a schematic flowchart of a parameter adjustment method provided in an embodiment of the present application.
  • the change of the patient state type is to first judge whether the real-time characteristic signal of the patient changes. Only when the real-time characteristic signal changes, the state classification model is used for classification operation to obtain the real-time state type of the patient. In this process, there is no need to Real-time use of the state classification model for classification operations, and the amount of computation to determine whether the real-time feature signal has changed is much smaller than that of using the state classification model for classification operations, so the process occupies less computing resources.
  • the embodiment of the present application provides a parameter adjustment method of an implantable neurostimulator, which is applied to an implanted neurostimulator.
  • the implanted neurostimulator includes: a plurality of electrodes 101 capable of being positioned within the brain of a patient to deliver therapy or sense electrical activity to the patient; therapy delivery circuitry 102 operatively coupled to the a plurality of electrodes 101 to deliver therapy to the patient; a sensing circuit 103 operatively coupled to the plurality of electrodes 101 to sense electrical activity; a controller 104 the controller 104 Comprising processing circuitry operatively coupled to the therapy delivery circuit 102 and the sensing circuit 103; the method includes steps S101-S107.
  • an implantable neurostimulator refers to a device that generates electrical stimulation to stimulate specific nerves or muscles in the patient's body to intervene in the patient's specific symptoms, such as the Deep Brain Stimulation System (Deep Brain Stimulation) , referred to as DBS), implanted cortical stimulation system (Cortical Nerve Stimulation, referred to as CNS), implanted spinal cord stimulation system (Spinal Cord Stimulation, referred to as SCS), implanted sacral nerve stimulation system (Sacral Nerve Stimulation, SNS for short), implantable vagus nerve stimulation system (Vagus Nerve Stimulation, VNS for short), etc.
  • DBS Deep Brain Stimulation System
  • CNS Cortical Nerve Stimulation
  • SCS Spinal Cord Stimulation
  • Sacral Nerve Stimulation Spinal Cord Stimulation
  • Vagus Nerve Stimulation VNS for short
  • the parameters of the stimulator are, for example, frequency (number of pulses per unit time 1s, unit is Hz), pulse width (duration of each pulse, unit is ⁇ s), and amplitude (generally expressed in voltage, that is, each pulse The intensity of , the unit is V).
  • various parameters of the stimulator can be adjusted in current mode or voltage mode.
  • the patients in the embodiments of the present application may be patients with Parkinson's disease, or patients with mental illnesses such as depression patients and obsessive-compulsive disorder patients, or patients with drug addiction or drug addicts.
  • Parkinson's patients the most commonly used parameters are 130Hz, 60 ⁇ s and a voltage of 2-3V.
  • pulse stimulation greater than 100 Hz can be effective, and low frequency stimulation may even aggravate tremor.
  • Step S101 Sensing the potentials of two electrodes corresponding to a recommended electrode combination in real time through the sensing circuit, the recommended electrode combination including two of the plurality of electrodes.
  • Step S102 Based on the potentials of the two electrodes corresponding to the recommended electrode combination, calculate the real-time voltage between the two electrodes corresponding to the recommended electrode combination.
  • Step S103 Based on the real-time voltage between the two electrodes corresponding to the recommended electrode combination from the preset moment to the current moment, obtain the real-time characteristic signal at the current moment corresponding to the recommended electrode combination, and the preset moment is at the current moment. before the present moment.
  • Step S104 Input the real-time characteristic signal at the current moment and the real-time characteristic signal at the previous moment corresponding to the recommended electrode combination into the similarity detection model, and obtain the real-time characteristic signal at the current moment and the real-time characteristic signal at the previous moment corresponding to the recommended electrode combination
  • the similarity between real-time feature signals, the similarity detection model is obtained by pre-training.
  • Step S105 When the similarity between the real-time characteristic signal at the current moment corresponding to the recommended electrode combination and the real-time characteristic signal at the previous moment is not greater than the preset similarity, calculate the real-time characteristic signal at the current moment corresponding to the recommended electrode combination
  • the characteristic signal is input into the state classification model to obtain the real-time state type of the patient, and the state classification model is obtained through pre-training.
  • the similarity between the real-time characteristic signal at the current moment and the real-time characteristic signal at the previous moment corresponding to the recommended electrode combination is not greater than the preset similarity, indicating that the real-time characteristic signal at the current moment is similar to the real-time characteristic signal at the previous moment
  • the degree of similarity between the real-time characteristic signal at the current moment corresponding to the recommended electrode combination and the real-time characteristic signal at the previous moment is greater than the preset similarity degree, indicating that the real-time characteristic signal at the current moment has a high similarity with the real-time characteristic signal at the previous moment, and the real-time characteristic signal has not changed significantly compared with the previous moment.
  • the preset similarity is, for example, 80%, 85% or 90%.
  • the patient's state type may refer to the classification type of the patient's current activity state, for example, may include at least one of the following: before going to bed, after waking up, after taking medicine, after a meal, during exercise, and during an attack; or, the patient's state
  • the type may refer to the classification type of the patient's current emotional state, for example, may include at least one of the following: normal, fatigue, depression, depression, happiness, etc.; for different patient states, the optimal treatment parameters are different.
  • Step S106 Obtain parameter configuration information based on the real-time status type of the patient.
  • the parameter configuration information refers to the information used to indicate the parameters when delivering treatment to the patient, which may be the configuration information pre-stored in the implantable neurostimulator, or the configuration information acquired from the cloud server through the network, It can also be manually entered configuration information.
  • Step S107 Based on the parameter configuration information, control one or more of the plurality of electrodes to deliver therapy to the patient through the therapy delivery circuit.
  • the potential of the electrode corresponding to the recommended electrode combination is used to obtain the voltage between the two electrodes, and then the real-time characteristic signal is obtained according to the voltage, and the similarity of the real-time characteristic signal compared with the previous moment is detected.
  • the similarity is not greater than the predetermined
  • the computing load is lower, saving computing resources, and improving the running speed of processes corresponding to other functions of the implantable neurostimulation system.
  • FIG. 4 is a partial schematic flowchart of another parameter adjustment method provided by an embodiment of the present application.
  • the method may further include steps S108-S1012.
  • Step S108 Sensing the potentials of the plurality of electrodes through the sensing circuit.
  • Step S109 Based on the sensed potentials of the plurality of electrodes, calculate the difference between the potentials of any two of the electrodes to obtain the voltage between the any two electrodes.
  • Step S110 Based on the voltage between the any two electrodes within a preset time range, obtain the characteristic signal corresponding to the electrode combination formed by the any two electrodes.
  • Step S111 Obtain a score corresponding to each electrode combination based on one or more of the signal strength, pulse width, and similarity between the characteristic signal and the expected signal corresponding to each electrode combination.
  • Step S112 Based on the scores corresponding to all electrode combinations, use the electrode combination with the highest score as the recommended electrode combination.
  • a method for obtaining a recommended electrode combination Based on the voltage between any two electrodes within a preset time range, the characteristic signal is obtained, and then the score is calculated based on one or more characteristics of the plurality of characteristic signals. The one with the highest score is the recommended electrode combination, and the obtained recommended electrode combination can reflect the real state of the patient to the greatest extent, making the parameter adjustment based on the recommended electrode combination more accurate.
  • FIG. 5 is a schematic flowchart of obtaining parameter configuration information provided by an embodiment of the present application.
  • the step S106 may include step S201 or step S202:
  • Step S201 Input the real-time state type of the patient into the parameter configuration model to obtain the parameter configuration information corresponding to the real-time state type, and the parameter configuration model is obtained through pre-training; or
  • Step S202 Send the real-time state type of the patient to the program-controlled device, so that the program-controlled device sends the real-time state type to the user equipment corresponding to the patient, and receives the parameter configuration information sent by the program-controlled device, the The parameter configuration information is obtained through manual configuration.
  • using the parameter configuration model to obtain parameter configuration information based on real-time status types can quickly and automatically obtain parameter configuration information, respond to changes in patient status in a timely manner, and improve the effect of delivering treatment to patients; or, use manual configuration based on real-time status Type to obtain parameter configuration information, the obtained parameter configuration information is accurate, and can flexibly adjust parameters for specific patients, which helps to improve the treatment effect.
  • FIG. 6 is a schematic flow chart of obtaining a user equipment corresponding to a patient provided by an embodiment of the present application.
  • the acquiring process of the user equipment corresponding to the patient may include steps S301-S302.
  • Step S301 Based on the real-time status type of the patient, query the real-time communication level corresponding to the real-time status type, wherein, for the patient, each communication level corresponds to one or more user equipments, and each of the communication The user equipment corresponding to the level is manually configured, and the real-time communication level is one of the communication levels.
  • Step S302 Obtain the user equipment at the real-time communication level corresponding to the patient.
  • the communication level refers to the level of the group corresponding to different user equipment.
  • the user equipment may include the patient's mobile phone, the patient's tablet computer, the patient's family mobile phone, the patient's escort mobile phone, the patient's corresponding doctor's mobile phone, and the patient's corresponding doctor's mobile phone.
  • patient mobile phones and patient tablet computers are classified as the first level
  • patient mobile phones, patient tablet computers, patient family mobile phones, and patient accompanying personnel mobile phones are classified as the second level.
  • the patient’s mobile phone, patient’s tablet computer, patient’s family mobile phone, patient’s accompanying person’s mobile phone, patient’s corresponding doctor’s mobile phone, patient’s corresponding doctor’s tablet computer are classified into the third level, patient’s mobile phone, patient’s tablet computer, patient’s family’s mobile phone, patient’s
  • the mobile phones of accompanying personnel, mobile phones of doctors corresponding to patients, tablet computers of doctors corresponding to patients, and mobile phones of emergency rescue personnel are classified as the fourth level.
  • the above-mentioned first level is used as the real-time communication level, and patient A’s mobile phone and patient A’s tablet are the corresponding user equipment of patient A.
  • patient A himself receives
  • the real-time status type is after meal; in other application scenarios, the real-time status type of patient B is after taking medicine, then the above-mentioned third level is used as the real-time communication level, at least the mobile phone of the doctor corresponding to patient B and the doctor corresponding to patient B
  • the tablet computer of patient B is the user equipment corresponding to patient B.
  • At least the doctor corresponding to patient B receives the real-time status type of taking medicine, which is convenient for the doctor to track the status and adjust the parameters of patient B; in other application scenarios, patient C suddenly becomes ill, If the real-time status type of patient C is onset, the above-mentioned fourth level is used as the real-time communication level.
  • the computer and the mobile phone of the emergency rescue personnel are used as the user equipment corresponding to patient C.
  • the family members, escorts, corresponding doctors and emergency rescue personnel of patient C can all know that patient C is sick in time, which is convenient for the status tracking and emergency management of patient C. ambulance.
  • the real-time status type that can represent the current risk level of the patient corresponds to the communication level, and the patient's situation can be selectively notified to specific personnel or all personnel related to the patient according to the different risk levels corresponding to the current patient status. On the one hand, it will not disturb the doctor when the patient has a minor problem, avoiding increasing the workload of the doctor and wasting medical resources; on the other hand, when the patient has a major problem, it will promptly notify all the personnel related to the patient, so that rescue forces can be launched in time.
  • the real-time communication level corresponding to the state type is determined, and the user equipment corresponding to the patient is acquired based on the real-time communication level, so that different user equipment can be acquired for different real-time state types of the patient, so that when the patient is in In different states, the corresponding personnel can know the state of the patient in time.
  • the step S107 may include step S401.
  • Step S401 Based on the parameter configuration information, through the treatment delivery circuit, control the two electrodes corresponding to the recommended electrode combination to deliver treatment to the patient.
  • the treatment is delivered based on the electrodes corresponding to the recommended electrode combination based on the parameter configuration information. Since the parameter configuration information is obtained based on the recommended electrode combination, it is more accurate to deliver treatment based on the electrodes corresponding to the recommended electrode combination.
  • FIG. 7 is a partial schematic flowchart of another parameter adjustment method provided in an embodiment of the present application.
  • the method may further include step S113.
  • Step S113 When the similarity between the real-time characteristic signal at the current moment and the real-time characteristic signal at the previous moment corresponding to the recommended electrode combination is not greater than the preset similarity, determine that the patient has a state change, and record the The current moment and the real-time characteristic signal at the present moment corresponding to the recommended electrode combination.
  • FIG. 8 is a partial flowchart of another parameter adjustment method provided by the embodiment of the present application.
  • the method may further include steps S114-S115.
  • Step S114 Send the real-time status type of the patient to the program-controlled device, so that the program-controlled device sends status change prompt information including the real-time status type to the user equipment corresponding to the patient.
  • Step S115 Utilize the program-controlled device to receive the confirmation operation or modification operation on the real-time status type sent by the user equipment corresponding to the patient, confirm or modify the real-time status type, and then combine the real-time status type with the The real-time characteristic signal corresponding to the recommended electrode combination is associated and stored as training data for updating the state classification model.
  • the real-time state type of patient D is determined to be in motion.
  • the real-time state type is sent to the program-controlled device, and further sent to the mobile phone of patient D.
  • Patient D recognizes the real-time The state type is wrong, and use his mobile phone to modify the real-time state type to after taking medicine; then the modified state type of patient D and the real-time characteristic signal corresponding to the current electrode combination are associated and stored, and the model parameters are updated according to the associated stored training data , so that the next time patient D takes the medicine, its real-time status type is correctly determined as after taking the medicine, wherein the storage location can be the storage medium in the program-controlled device of patient D, or it can be in the network structure including the program-controlled device of patient D
  • the cloud server the update of the model parameters can be run in the program-controlled device of patient D, and can also be run in the cloud server, and the updated model parameters are sent to the program-controlled device of patient D.
  • the status change prompt information is sent to the user equipment, and the confirmation or modification operation of the user is received, and the confirmed or modified real-time status type and the real-time characteristic signal are associated and stored to update the status classification model.
  • the confirmation and modification of the state classification further optimizes the recognition accuracy of the state classification model, and finally improves the accuracy of parameter adjustment.
  • FIG. 9 is a partial flowchart of another parameter adjustment method provided by the embodiment of the present application.
  • the method may further include steps S116-S117.
  • Step S116 Control one or more of the plurality of electrodes to deliver therapy to the patient through the therapy delivery circuit.
  • Step S117 During the process of delivering the treatment, the potentials of the plurality of electrodes are sensed by the sensing circuit.
  • sensing the potential of multiple electrodes can reflect the change of the patient's state during the treatment process, and the parameter adjustment can reflect the impact of the treatment on the patient's state, which is convenient for medical personnel to adjust and research .
  • FIG. 10 is a schematic structural diagram of an implantable neurostimulator provided in an embodiment of the present application.
  • the embodiment of the present application also provides an implantable neurostimulator, including: a plurality of electrodes 101, the plurality of electrodes 101 can be positioned in the patient's brain to deliver therapy or sense electrical activity to the patient; a therapy delivery circuit 102, the therapy delivery circuit 102 is operatively coupled to the plurality of electrodes 101 to deliver therapy to the patient; a sensing circuit 103, the sensing circuit 103 is operatively coupled to the plurality of electrodes 101 to sense electrical activity; a controller 104 comprising processing circuitry operatively coupled to the therapy delivery circuit 102 and the sensing circuit 103, the controller 104 being configured to: The sensing circuit senses the potentials of two electrodes corresponding to the recommended electrode combination in real time, and the recommended electrode combination includes two of the plurality of electrodes, based on the potentials of the two electrodes corresponding to the recommended electrode combination, Calculate the real-
  • the controller 104 may also be configured to obtain the recommended electrode combination in the following manner: through the sensing circuit, sensing the potentials of the plurality of electrodes; The potentials of the plurality of electrodes are calculated, and the difference between the potentials of any two electrodes is calculated to obtain the voltage between the two electrodes; based on the voltage between the two electrodes within the preset time range, the obtained The characteristic signal corresponding to the electrode combination formed by any two electrodes; based on one or more of the signal strength, pulse width and similarity between the characteristic signal and the expected signal of the characteristic signal corresponding to each electrode combination, obtain The score corresponding to each electrode combination; based on the scores corresponding to all electrode combinations, the electrode combination with the highest score is used as the recommended electrode combination.
  • the controller 104 may be further configured to obtain the parameter configuration information in the following manner: input the real-time state type of the patient into the parameter configuration model to obtain the parameter configuration corresponding to the real-time state type information, the parameter configuration model is pre-trained; or
  • the controller 104 may also be configured to obtain the user equipment corresponding to the patient in the following manner: based on the real-time status type of the patient, query the real-time communication level corresponding to the real-time status type , wherein, for the patient, each communication level corresponds to one or more user equipment, and the user equipment corresponding to each communication level is manually configured, and the real-time communication level is one of the communication levels ; Obtain the user equipment corresponding to the patient at the real-time communication level.
  • the controller 104 may be further configured to deliver therapy to the patient in the following manner: based on the parameter configuration information, through the therapy delivery circuit, control the two electrodes corresponding to the recommended electrode combination electrodes to deliver therapy to the patient.
  • the controller 104 may also be configured to: when the similarity between the real-time characteristic signal at the current moment and the real-time characteristic signal at the previous moment corresponding to the recommended electrode combination is not greater than the preset similarity When the degree is higher, it is determined that the patient has a state change, and the real-time characteristic signal at the current moment corresponding to the recommended electrode combination is recorded.
  • the controller 104 may also be configured to: send the real-time status type of the patient to the program-controlled device, so that the program-controlled device sends the real-time State change prompt information of the state type; use the program-controlled device to receive the confirmation operation or modification operation for the real-time state type sent by the user equipment corresponding to the patient, confirm or modify the real-time state type, and then update the real-time state type
  • the state type and the real-time characteristic signal corresponding to the recommended electrode combination are associated and stored as training data for updating the state classification model.
  • the controller 104 can also be configured to: control one or more of the plurality of electrodes to deliver therapy to the patient through the therapy delivery circuit; , sensing potentials of the plurality of electrodes through the sensing circuit.
  • An embodiment of the present application also provides an implantable neurostimulator system, including a program-controlled device and any one of the above-mentioned implanted neurostimulators.
  • the program-controlled device may be provided with a touch screen.
  • FIG. 11 is a schematic structural diagram of an electronic device provided by an embodiment of the present application.
  • the embodiment of the present application also provides an electronic device 200, and the electronic device 200 includes at least one memory 210, at least one processor 220, and a bus 230 connecting different platform systems.
  • Memory 210 may include readable media in the form of volatile memory, such as random access memory (RAM) 211 and/or cache memory 212 , and may further include read only memory (ROM) 213 .
  • RAM random access memory
  • ROM read only memory
  • the memory 210 also stores a computer program, and the computer program can be executed by the processor 220, so that the processor 220 executes the steps of the parameter adjustment method in the embodiment of the present application.
  • the implementation mode and the achieved technical effect are the same, and part of the content will not be repeated.
  • Memory 210 may also include utility 214 having at least one program module 215 including, but not limited to, an operating system, one or more application programs, other program modules, and program data, examples of each or Implementations of network environments may be included in some combination.
  • program module 215 including, but not limited to, an operating system, one or more application programs, other program modules, and program data, examples of each or Implementations of network environments may be included in some combination.
  • the processor 220 can execute the above-mentioned computer program, and can execute the utility tool 214 .
  • Bus 230 may be representative of one or more of several types of bus structures, including a memory bus or memory controller 104, a peripheral bus, an accelerated graphics port, a processor, or a local bus using any of a variety of bus structures. .
  • the electronic device 200 can also communicate with one or more external devices 240 such as keyboards, pointing devices, Bluetooth devices, etc., and can also communicate with one or more devices capable of interacting with the electronic device 200, and/or communicate with the electronic device 200 200 is capable of communicating with any device (eg, router, modem, etc.) that communicates with one or more other computing devices. Such communication may occur through input-output interface 250 .
  • the electronic device 200 can also communicate with one or more networks (such as a local area network (LAN), a wide area network (WAN) and/or a public network such as the Internet) through the network adapter 260 .
  • the network adapter 260 can communicate with other modules of the electronic device 200 through the bus 230 . It should be appreciated that although not shown, other hardware and/or software modules may be used in conjunction with electronic device 200, including but not limited to: microcode, device drivers, redundant processors, external disk drive arrays, RAID systems, tape drives And data backup storage platform, etc.
  • the embodiment of the present application also provides a computer-readable storage medium, which is used to store a computer program.
  • a computer program When the computer program is executed, the steps of the parameter adjustment method in the embodiment of the present application are realized.
  • the specific implementation method The implementation mode and the achieved technical effect are consistent with those described in the above-mentioned embodiment of the parameter adjustment method, and part of the content will not be repeated here.
  • Fig. 12 shows the program product 300 for realizing the above-mentioned implantable neurostimulator provided by this embodiment, which can adopt a portable compact disk read-only memory (CD-ROM) and include program codes, and can be installed on the terminal equipment, For example running on a personal computer.
  • a readable storage medium may be any tangible medium containing or storing a program, and the program may be used by or in combination with an instruction execution system, device or device.
  • Program product 300 may utilize any combination of one or more readable media.
  • the readable medium may be a readable signal medium or a readable storage medium.
  • the readable storage medium may be, for example, but not limited to, an electrical, magnetic, optical, electromagnetic, infrared, or semiconductor system, device, or device, or any combination thereof. More specific examples (non-exhaustive list) of readable storage media include: electrical connection with one or more conductors, portable disk, hard disk, random access memory (RAM), read only memory (ROM), erasable programmable read-only memory (EPROM or flash memory), optical fiber, portable compact disk read-only memory (CD-ROM), optical storage devices, magnetic storage devices, or any suitable combination of the foregoing.
  • RAM random access memory
  • ROM read only memory
  • EPROM or flash memory erasable programmable read-only memory
  • CD-ROM compact disk read-only memory
  • optical storage devices magnetic storage devices, or any suitable combination of the foregoing.
  • a computer readable storage medium may include a data signal carrying readable program code in baseband or as part of a carrier wave traveling as part of a data signal. Such propagated data signals may take many forms, including but not limited to electromagnetic signals, optical signals, or any suitable combination of the foregoing.
  • a readable storage medium may also be any readable medium that can transmit, propagate, or transport a program for use by or in connection with an instruction execution system, apparatus, or device.
  • the program code contained on the readable storage medium can be transmitted by any appropriate medium, including but not limited to wireless, cable, optical cable, RF, etc., or any suitable combination of the above.
  • the program codes for performing the operations of the present invention can be written in any combination of one or more programming languages, and the programming languages include object-oriented programming languages such as Java, C++, etc., and also include conventional procedural programming languages A programming language such as C or similar.
  • the program code may execute entirely on the user's computing device, partly on the user's device, as a stand-alone software package, partly on the user's computing device and partly on a remote computing device, or entirely on the remote computing device or server to execute.
  • the remote computing device may be connected to the user computing device through any kind of network, including a local area network (LAN) or a wide area network (WAN), or may be connected to an external computing device (e.g., using an Internet service provider). business to connect via the Internet).
  • LAN local area network
  • WAN wide area network
  • Internet service provider e.g., a wide area network

Abstract

An implantable nerve stimulator and an implantable nerve stimulation system. A controller (104) of the implantable nerve stimulator is configured to: sense the potentials of two electrodes (101) corresponding to a recommended electrode (101) combination in real time, and calculate a real-time voltage; obtain a real-time feature signal at the current time corresponding to the recommended electrode (101) combination, and input the real-time feature signal at the current time corresponding to the recommended electrode (101) combination and a real-time feature signal at a previous time into a similarity detection model, so as to obtain a similarity; and when the similarity is not greater than a preset similarity, obtain parameter configuration information, and control the electrodes (101) to deliver therapy. A real-time state type is only obtained after a feature signal is changed, and thus, the operation resource is saved, and the running speeds of processes corresponding to the remaining functions of the implantable nerve stimulation system are improved.

Description

植入式神经刺激器和植入式神经刺激系统Implantable neurostimulators and implantable neurostimulation systems
本申请要求于2021年10月26日提交的申请号为202111246300.4的中国专利的优先权,上述中国专利通过全文引用的形式并入。This application claims the priority of the Chinese patent with application number 202111246300.4 filed on October 26, 2021, which is incorporated by reference in its entirety.
技术领域technical field
本申请涉及植入式神经刺激器技术领域,尤其涉及植入式神经刺激器和植入式神经刺激系统。The present application relates to the technical field of implantable neurostimulators, in particular to implanted neurostimulators and implanted neurostimulator systems.
背景技术Background technique
植入式神经刺激系统主要包括植入体内的刺激器、电极以及体外的程控设备。现有的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。Implantable neurostimulation systems mainly include stimulators implanted in the body, electrodes and program-controlled equipment outside the body. The existing neuromodulation technology mainly uses stereotaxic surgery to implant electrodes in specific structures (i.e., targets) in the body, and the stimulator implanted in the patient sends electrical pulses to the targets through the electrodes to regulate the corresponding neural structures and networks. Electrical activity and its function, thereby improving symptoms and relieving pain.
患者在医院接受医生神经调控后,回到家后随着环境变化或者自身状态的变化,例如吃药、运动、睡觉等行为造成的自身状态的变化,需要对患者体内的刺激器的参数进行微调以达到最好的刺激效果。After receiving neuromodulation by doctors in the hospital, the patient needs to fine-tune the parameters of the stimulator in the patient's body as the environment changes or changes in his own state after returning home, such as changes in his own state caused by taking medicine, exercising, sleeping and other behaviors. achieve the best stimulating effect.
通常情况下,现有的参数调整方法一般都是由医生设定一个刺激参数范围,由患者自行调节,此种调节方法是一种被动且非常不准确的调节方法,实际的效果并不理想。也有通过根据医生设定的随时间变化的刺激参数组来让设备自动切换参数的方法,这种方法同样无法精确匹配患者状态,刺激效果较差。Usually, the existing parameter adjustment method is to set a stimulation parameter range by the doctor and adjust it by the patient himself. This adjustment method is a passive and very inaccurate adjustment method, and the actual effect is not ideal. There is also a method of allowing the device to automatically switch parameters according to the time-varying stimulation parameter set set by the doctor. This method also cannot accurately match the patient's state, and the stimulation effect is poor.
中国发明专利CN113244533A公开了一种参数调整方法、装置、电子设备及计算机可读存储介质,方法包括:利用设置于患者体外的程控设备接收标记操作,响应于标记操作,利用刺激器采集患者的脑电信号;将患者的脑电信号和状态类型关联存储至第一数据集;利用第一数据集训练第一深度学习模型,得到状态分类模型;利用刺激器采集患者的实时脑电信号;将实时脑电信号输入状态分类模型,得到实时脑电信号对应的实时状态类型;获取实时状态类型对应的参数配置信息;利用程控设备调整刺激器的参数,以使刺激器对患者施加对应的电刺激。该方法可以为患者施加及时且准确的电刺激,刺激效果佳。Chinese invention patent CN113244533A discloses a parameter adjustment method, device, electronic equipment, and computer-readable storage medium. The method includes: using a program-controlled device installed outside the patient's body to receive a marking operation, and using a stimulator to collect the brain of the patient in response to the marking operation. Electric signal; associate and store the patient's EEG signal and state type into the first data set; use the first data set to train the first deep learning model to obtain a state classification model; use the stimulator to collect the patient's real-time EEG signal; convert the real-time The EEG signal is input to the state classification model to obtain the real-time state type corresponding to the real-time EEG signal; obtain the parameter configuration information corresponding to the real-time state type; use the program-controlled equipment to adjust the parameters of the stimulator so that the stimulator can apply corresponding electrical stimulation to the patient. The method can apply timely and accurate electrical stimulation to the patient, and the stimulation effect is good.
然而,上述现有技术中,需要对实时脑电信号进行实时地分析与运算,从而实时地获得脑电信号对应的实时状态类型,状态分类模型实时运行计算,导致运 算量大,占用宝贵的运算资源,降低了植入式神经刺激系统其余功能所对应的进程的运行速度。However, in the above prior art, it is necessary to analyze and calculate the real-time EEG signal in real time, so as to obtain the real-time state type corresponding to the EEG signal in real time, and the state classification model runs and calculates in real time, resulting in a large amount of calculation and taking up valuable calculation resources, slowing down processes for the rest of the Implantable Neurostimulation System's functionality.
发明内容Contents of the invention
本申请的目的在于提供植入式神经刺激器和植入式神经刺激系统,解决了现有技术中进行参数调整时,植入式神经刺激系统的运算量大,占用宝贵的运算资源,降低了植入式神经刺激系统其余功能所对应的进程的运行速度的问题。The purpose of this application is to provide an implantable neurostimulator and an implanted neurostimulation system, which solves the problem that the implanted neurostimulation system has a large amount of computation when adjusting parameters in the prior art, takes up valuable computing resources, and reduces the The problem of the running speed of the processes corresponding to the remaining functions of the implantable neurostimulation system.
本申请的目的采用以下技术方案实现:The purpose of this application adopts following technical scheme to realize:
第一方面,本申请提供了一种植入式神经刺激器的参数调整方法,应用于植入式神经刺激器,所述植入式神经刺激器包括:多个电极,所述多个电极能够定位于患者脑内,以向所述患者递送治疗或者感测电活动;治疗递送电路,所述治疗递送电路可操作地耦接到所述多个电极以向所述患者递送治疗;感测电路,所述感测电路可操作地耦接到所述多个电极以感测电活动;控制器,所述控制器包括可操作地耦接到所述治疗递送电路和所述感测电路的处理电路系统;所述方法包括:通过感测电路,实时感测推荐电极组合对应的两个电极的电位,所述推荐电极组合包括所述多个电极的其中两个,基于所述推荐电极组合对应的两个电极的电位,计算所述推荐电极组合对应的两个电极之间的实时电压;基于从预设时刻至当前时刻内所述推荐电极组合对应的两个电极之间的实时电压,获取所述推荐电极组合对应的当前时刻的实时特征信号,所述预设时刻在所述当前时刻之前,将所述推荐电极组合对应的当前时刻的实时特征信号和上一时刻的实时特征信号输入相似度检测模型,得到所述推荐电极组合对应的当前时刻的实时特征信号和上一时刻的实时特征信号之间的相似度,所述相似度检测模型是预先训练得到的,当所述推荐电极组合对应的当前时刻的实时特征信号和上一时刻的实时特征信号之间的相似度不大于预设相似度时,将所述推荐电极组合对应的当前时刻的实时特征信号输入状态分类模型,得到所述患者的实时状态类型,所述状态分类模型是预先训练得到的,基于所述患者的实时状态类型,获取参数配置信息,基于所述参数配置信息,通过所述治疗递送电路,控制所述多个电极中的一个或多个向所述患者递送治疗。In a first aspect, the present application provides a method for adjusting parameters of an implantable neurostimulator, which is applied to an implanted neurostimulator, and the implanted neurostimulator includes: a plurality of electrodes, and the plurality of electrodes can be positioned within the brain of a patient to deliver therapy to the patient or to sense electrical activity; therapy delivery circuitry operably coupled to the plurality of electrodes to deliver therapy to the patient; sensing circuitry, the sensing circuit is operatively coupled to the plurality of electrodes to sense electrical activity; a controller comprising a processing circuit operably coupled to the therapy delivery circuit and the sensing circuit The system; the method includes: through the sensing circuit, real-time sensing the potential of two electrodes corresponding to the recommended electrode combination, the recommended electrode combination includes two of the plurality of electrodes, based on the potential of the recommended electrode combination corresponding to the potentials of the two electrodes, and calculate the real-time voltage between the two electrodes corresponding to the recommended electrode combination; based on the real-time voltage between the two electrodes corresponding to the recommended electrode combination from the preset moment to the current moment, obtain the real-time voltage between the two electrodes corresponding to the recommended electrode combination The real-time feature signal at the current moment corresponding to the recommended electrode combination, the preset time is before the current moment, and the real-time feature signal at the current moment corresponding to the recommended electrode combination and the real-time feature signal at the previous moment are input into the similarity A detection model to obtain the similarity between the real-time characteristic signal at the current moment corresponding to the recommended electrode combination and the real-time characteristic signal at the previous moment, the similarity detection model is obtained by pre-training, when the recommended electrode combination corresponds to When the similarity between the real-time characteristic signal at the current moment and the real-time characteristic signal at the previous moment is not greater than the preset similarity, input the real-time characteristic signal at the current moment corresponding to the recommended electrode combination into the state classification model to obtain the The real-time state type of the patient, the state classification model is pre-trained, parameter configuration information is obtained based on the real-time state type of the patient, and the multiple therapy delivery circuits are controlled based on the parameter configuration information. One or more of the electrodes deliver therapy to the patient.
该技术方案的有益效果在于,利用推荐电极组合对应的电极的电位获得两个电极之间的电压,然后根据该电压获得实时特征信号,检测实时特征信号相比于 上一时刻的相似度,只有当相似度不大于预设相似度时(意味着当前时刻的实时特征信号与上一时刻的实时特征信号不同),才会对当前时刻的实时特征信号进行分类,得到实时状态类型,并根据该实时状态类型获取参数配置信息用以控制电极向患者递送治疗;相比于实时获取状态类型,实时获取相似度的运算量更低,节省了运算资源,提高了植入式神经刺激系统其余功能所对应的进程的运行速度。The beneficial effect of this technical solution is that the potential of the electrode corresponding to the recommended electrode combination is used to obtain the voltage between the two electrodes, and then the real-time characteristic signal is obtained according to the voltage, and the similarity between the real-time characteristic signal and the previous moment is detected, only When the similarity is not greater than the preset similarity (meaning that the real-time characteristic signal at the current moment is different from the real-time characteristic signal at the previous moment), the real-time characteristic signal at the current moment will be classified to obtain the real-time state type, and according to the The real-time state type obtains parameter configuration information to control the electrode to deliver treatment to the patient; compared with the real-time state type, the real-time obtainment of similarity requires less calculation, saves computing resources, and improves the performance of other functions of the implantable neurostimulation system. The running speed of the corresponding process.
在一种可能的实现方式中,所述方法还包括:通过所述感测电路,感测所述多个电极的电位;基于感测到的所述多个电极的电位,计算其中任意两个电极的电位的差值,得到所述任意两个电极之间的电压;基于预设时间范围以内的所述任意两个电极之间的电压,获取所述任意两个电极形成的电极组合对应的特征信号;基于每个电极组合对应的特征信号的信号强度、脉宽以及所述特征信号与期望信号的相似度中的一种或多种,获取每个电极组合对应的得分;基于所有电极组合对应的得分,将得分最高的电极组合作为所述推荐电极组合。In a possible implementation manner, the method further includes: sensing the potentials of the plurality of electrodes through the sensing circuit; calculating any two of the potentials based on the sensed potentials of the plurality of electrodes The difference between the potentials of the electrodes is used to obtain the voltage between any two electrodes; based on the voltage between any two electrodes within a preset time range, the corresponding electrode combination formed by the two electrodes is obtained. Characteristic signal: Based on one or more of the signal strength, pulse width and similarity between the characteristic signal and the expected signal of the characteristic signal corresponding to each electrode combination, obtain the score corresponding to each electrode combination; based on all electrode combinations Corresponding to the score, the electrode combination with the highest score is used as the recommended electrode combination.
该技术方案的有益效果在于,提供一种获取推荐电极组合的方法,基于预设时间范围内的任意两个电极之间的电压,获取特征信号,然后基于多个特征信号的一种或多种特征计算得分,将得分最高者作为推荐电极组合,所得到的推荐电极组合可以最大程度上反应患者的真实状态,使得基于该推荐电极组合所进行的参数调整更加准确。The beneficial effect of this technical solution is to provide a method for obtaining recommended electrode combinations, based on the voltage between any two electrodes within a preset time range, to obtain a characteristic signal, and then based on one or more of a plurality of characteristic signals Scores are calculated for features, and the one with the highest score is used as the recommended electrode combination. The obtained recommended electrode combination can reflect the real state of the patient to the greatest extent, making the parameter adjustment based on the recommended electrode combination more accurate.
在一种可能的实现方式中,所述基于所述患者的实时状态类型,获取参数配置信息包括:将所述患者的实时状态类型输入参数配置模型,得到所述实时状态类型对应的参数配置信息,所述参数配置模型是预先训练得到的;或者将所述患者的实时状态类型发送至程控设备,以使程控设备将所述实时状态类型发送至所述患者对应的用户设备,以及接收所述程控设备发送的参数配置信息,所述参数配置信息是手动配置得到的。In a possible implementation manner, the acquiring parameter configuration information based on the real-time state type of the patient includes: inputting the real-time state type of the patient into a parameter configuration model to obtain parameter configuration information corresponding to the real-time state type , the parameter configuration model is pre-trained; or the real-time state type of the patient is sent to the program-controlled device, so that the program-controlled device sends the real-time state type to the user equipment corresponding to the patient, and receives the The parameter configuration information sent by the program-controlled device, the parameter configuration information is obtained through manual configuration.
该技术方案的有益效果在于,利用参数配置模型基于实时状态类型获取参数配置信息,能够快速、自动化地获取参数配置信息,及时地响应患者状态的变化,提高向患者递送治疗的效果;或者,利用手动配置基于实时状态类型获取参数配置信息,所得的参数配置信息准确,并且能够灵活地对特定患者进行参数调整,有助于提高治疗效果。The beneficial effect of this technical solution is that, using the parameter configuration model to obtain parameter configuration information based on real-time state types can quickly and automatically obtain parameter configuration information, respond to changes in patient status in a timely manner, and improve the effect of delivering treatment to patients; or, using Manual configuration obtains parameter configuration information based on real-time status types, and the obtained parameter configuration information is accurate, and can flexibly adjust parameters for specific patients, which helps to improve treatment effects.
在一种可能的实现方式中,所述患者对应的用户设备的获取包括以下步骤: 基于所述患者的实时状态类型,查询与所述实时状态类型相应的实时通信等级,其中,针对所述患者,每个通信等级对应一个或多个用户设备,且每个所述通信等级对应的用户设备是手动配置得到的,所述实时通信等级是所述通信等级的其中一个;获取所述患者对应的处于所述实时通信等级的用户设备。In a possible implementation manner, the acquisition of the user equipment corresponding to the patient includes the following steps: based on the real-time status type of the patient, querying the real-time communication level corresponding to the real-time status type, wherein, for the patient , each communication level corresponds to one or more user equipment, and the user equipment corresponding to each communication level is manually configured, and the real-time communication level is one of the communication levels; obtain the patient's corresponding User equipment at said real-time communication level.
该技术方案的有益效果在于,基于实时状态类型确定该状态类型对应的实时通信等级,并基于该实时通信等级来获取患者对应的用户设备,能够针对患者不同的实时状态类型,获取不同的用户设备,使得当患者处于不同的状态时,相应的人员能够及时获知患者的状态。The beneficial effect of this technical solution is that, based on the real-time state type, the real-time communication level corresponding to the state type is determined, and the user equipment corresponding to the patient is obtained based on the real-time communication level, and different user equipment can be obtained for different real-time state types of the patient. , so that when the patient is in a different state, the corresponding personnel can know the state of the patient in time.
在一种可能的实现方式中,所述基于所述参数配置信息,通过所述治疗递送电路,控制所述多个电极中的一个或多个向所述患者递送治疗包括:基于所述参数配置信息,通过所述治疗递送电路,控制所述推荐电极组合对应的两个电极向所述患者递送治疗。In a possible implementation manner, the controlling one or more of the plurality of electrodes to deliver therapy to the patient through the therapy delivery circuit based on the parameter configuration information includes: based on the parameter configuration information, and through the therapy delivery circuit, control the two electrodes corresponding to the recommended electrode combination to deliver therapy to the patient.
该技术方案的有益效果在于,基于参数配置信息基于推荐电极组合对应的电极来递送治疗,由于参数配置信息是基于推荐电极组合得到的,因此,基于推荐电极组合对应的电极来递送治疗会更加准确。The beneficial effect of this technical solution is that the treatment is delivered based on the electrodes corresponding to the recommended electrode combination based on the parameter configuration information. Since the parameter configuration information is obtained based on the recommended electrode combination, it will be more accurate to deliver treatment based on the electrodes corresponding to the recommended electrode combination .
在一种可能的实现方式中,所述方法还包括:当所述推荐电极组合对应的当前时刻的实时特征信号和上一时刻的实时特征信号之间的相似度不大于预设相似度时,确定所述患者发生状态变化,并且记录所述当前时刻和所述推荐电极组合对应的当前时刻的实时特征信号。In a possible implementation manner, the method further includes: when the similarity between the real-time characteristic signal at the current moment corresponding to the recommended electrode combination and the real-time characteristic signal at the previous moment is not greater than the preset similarity, It is determined that the patient has a state change, and the real-time characteristic signal at the current moment corresponding to the recommended electrode combination is recorded.
该技术方案的有益效果在于,利用相似度来确定患者状态的变化并记录当前时刻及其对应的实时特征信号,能够使得患者状态的变化以及对应的实时特征信号具有可追溯性,帮助医务人员对患者的状态进行回访和/或研究。The beneficial effect of this technical solution is that using the similarity to determine the change of the patient's state and recording the current moment and its corresponding real-time characteristic signal can make the change of the patient's state and the corresponding real-time characteristic signal traceable, and help medical staff to Patient status for follow-up visits and/or research.
在一种可能的实现方式中,所述方法还包括:将所述患者的实时状态类型发送至程控设备,以使所述程控设备向所述患者对应的用户设备发送包含所述实时状态类型的状态变化提示信息;利用所述程控设备接收所述患者对应的用户设备发送的对所述实时状态类型的确认操作或者修改操作,确认或者修改所述实时状态类型,再将所述实时状态类型和所述推荐电极组合对应的当前时刻的实时特征信号关联存储,作为训练数据,用于对所述状态分类模型进行更新。In a possible implementation manner, the method further includes: sending the real-time status type of the patient to a program-controlled device, so that the program-controlled device sends a message containing the real-time status type to the user equipment corresponding to the patient. State change prompt information; use the program-controlled device to receive the confirmation operation or modification operation on the real-time state type sent by the user equipment corresponding to the patient, confirm or modify the real-time state type, and then compare the real-time state type and The real-time characteristic signal corresponding to the recommended electrode combination is associated and stored as training data for updating the state classification model.
该技术方案的有益效果在于,将状态变化提示信息发送至用户设备,并接收 用户的确认或修改操作,并将确认或修改后的实时状态类型与实时特征信号关联存储用以更新状态分类模型,能够通过手动对实时状态分类的确认和修改进一步地优化状态分类模型的识别准确度,进而最终提高参数调整的准确度。The beneficial effect of the technical solution is that the state change prompt information is sent to the user equipment, and the confirmation or modification operation of the user is received, and the confirmed or modified real-time state type and the real-time characteristic signal are associated and stored to update the state classification model, The recognition accuracy of the state classification model can be further optimized by manually confirming and modifying the real-time state classification, thereby finally improving the accuracy of parameter adjustment.
在一种可能的实现方式中,所述方法还包括:通过所述治疗递送电路,控制所述多个电极中的一个或多个向所述患者递送治疗;在递送治疗的过程中,通过所述感测电路,感测所述多个电极的电位。In a possible implementation manner, the method further includes: controlling one or more of the plurality of electrodes to deliver therapy to the patient through the therapy delivery circuit; The sensing circuit senses the potentials of the plurality of electrodes.
该技术方案的有益效果在于,在递送治疗的过程中,感测多个电极的电位,能够反映治疗过程中患者状态的变化,所进行的参数调整可以反映出治疗对于患者状态的影响,便于医务人员的调整及研究。The beneficial effect of this technical solution is that during the process of delivering treatment, sensing the potential of multiple electrodes can reflect the change of the patient's state during the treatment process, and the parameter adjustment can reflect the impact of the treatment on the patient's state, which is convenient for medical treatment. Personnel adjustment and research.
第二方面,本申请提供一种植入式神经刺激器,包括:多个电极,所述多个电极能够定位于患者脑内,以向所述患者递送治疗或者感测电活动;治疗递送电路,所述治疗递送电路可操作地耦接到所述多个电极以向所述患者递送治疗;感测电路,所述感测电路可操作地耦接到所述多个电极以感测电活动;控制器,所述控制器包括可操作地耦接到所述治疗递送电路和所述感测电路的处理电路系统,所述控制器被配置成:通过所述感测电路,实时感测推荐电极组合对应的两个电极的电位,所述推荐电极组合包括所述多个电极的其中两个,基于所述推荐电极组合对应的两个电极的电位,计算所述推荐电极组合对应的两个电极之间的实时电压;基于从预设时刻至当前时刻内所述推荐电极组合对应的两个电极之间的实时电压,获取所述推荐电极组合对应的当前时刻的实时特征信号,所述预设时刻在所述当前时刻之前,将所述推荐电极组合对应的当前时刻的实时特征信号和上一时刻的实时特征信号输入相似度检测模型,得到所述推荐电极组合对应的当前时刻的实时特征信号和上一时刻的实时特征信号之间的相似度,所述相似度检测模型是预先训练得到的,当所述推荐电极组合对应的当前时刻的实时特征信号和上一时刻的实时特征信号之间的相似度不大于预设相似度时,将所述推荐电极组合对应的当前时刻的实时特征信号输入状态分类模型,得到所述患者的实时状态类型,所述状态分类模型是预先训练得到的,基于所述患者的实时状态类型,获取参数配置信息,基于所述参数配置信息,通过所述治疗递送电路,控制所述多个电极中的一个或多个向所述患者递送治疗。In a second aspect, the present application provides an implantable neurostimulator, comprising: a plurality of electrodes capable of being positioned in the brain of a patient to deliver therapy or sense electrical activity to the patient; a therapy delivery circuit, the therapy delivery circuit operably coupled to the plurality of electrodes to deliver therapy to the patient; a sensing circuit operatively coupled to the plurality of electrodes to sense electrical activity; a controller comprising processing circuitry operatively coupled to the therapy delivery circuit and the sensing circuit, the controller configured to sense, in real time, a recommended electrode via the sensing circuit Combine the potentials of the corresponding two electrodes, the recommended electrode combination includes two of the plurality of electrodes, and calculate the two electrodes corresponding to the recommended electrode combination based on the potentials of the two electrodes corresponding to the recommended electrode combination based on the real-time voltage between the two electrodes corresponding to the recommended electrode combination from the preset moment to the current moment, obtain the real-time characteristic signal corresponding to the recommended electrode combination at the current moment, the preset The time is before the current time, input the real-time feature signal at the current time corresponding to the recommended electrode combination and the real-time feature signal at the previous time into the similarity detection model, and obtain the real-time feature signal at the current time corresponding to the recommended electrode combination The similarity between the real-time characteristic signal and the previous moment, the similarity detection model is pre-trained, when the recommended electrode combination corresponds to the real-time characteristic signal at the current moment and the real-time characteristic signal at the previous moment When the similarity is not greater than the preset similarity, the real-time characteristic signal corresponding to the recommended electrode combination at the current moment is input into the state classification model to obtain the real-time state type of the patient. The state classification model is obtained by pre-training, Based on the real-time status type of the patient, parameter configuration information is obtained, and based on the parameter configuration information, one or more of the plurality of electrodes is controlled to deliver therapy to the patient through the therapy delivery circuit.
在一种可能的实现方式中,所述控制器还被配置成采用如下方式获取所述推 荐电极组合:通过所述感测电路,感测所述多个电极的电位;基于感测到的所述多个电极的电位,计算其中任意两个电极的电位的差值,得到所述任意两个电极之间的电压;基于预设时间范围以内的所述任意两个电极之间的电压,获取所述任意两个电极形成的电极组合对应的特征信号;基于每个电极组合对应的特征信号的信号强度、脉宽以及所述特征信号与期望信号的相似度中的一种或多种,获取每个电极组合对应的得分;基于所有电极组合对应的得分,将得分最高的电极组合作为所述推荐电极组合。In a possible implementation manner, the controller is further configured to obtain the recommended electrode combination in the following manner: through the sensing circuit, sensing the potentials of the plurality of electrodes; The potentials of the plurality of electrodes are calculated, and the difference between the potentials of any two electrodes is calculated to obtain the voltage between the two electrodes; based on the voltage between the two electrodes within the preset time range, the obtained The characteristic signal corresponding to the electrode combination formed by any two electrodes; based on one or more of the signal strength, pulse width and similarity between the characteristic signal and the expected signal of the characteristic signal corresponding to each electrode combination, obtain The score corresponding to each electrode combination; based on the scores corresponding to all electrode combinations, the electrode combination with the highest score is used as the recommended electrode combination.
在一种可能的实现方式中,所述控制器被进一步配置成采用如下方式获取所述参数配置信息:将所述患者的实时状态类型输入参数配置模型,得到所述实时状态类型对应的参数配置信息,所述参数配置模型是预先训练得到的;或者In a possible implementation manner, the controller is further configured to obtain the parameter configuration information in the following manner: input the real-time state type of the patient into the parameter configuration model to obtain the parameter configuration corresponding to the real-time state type information, the parameter configuration model is pre-trained; or
将所述患者的实时状态类型发送至程控设备,以使程控设备将所述实时状态类型发送至所述患者对应的用户设备,以及接收所述程控设备发送的参数配置信息,所述参数配置信息是手动配置得到的。Sending the real-time state type of the patient to the program-controlled device, so that the program-controlled device sends the real-time state type to the user equipment corresponding to the patient, and receives parameter configuration information sent by the program-controlled device, the parameter configuration information It is manually configured.
在一种可能的实现方式中,所述控制器还被配置成采用如下方式获取所述患者对应的用户设备:基于所述患者的实时状态类型,查询与所述实时状态类型相应的实时通信等级,其中,针对所述患者,每个通信等级对应一个或多个用户设备,且每个所述通信等级对应的用户设备是手动配置得到的,所述实时通信等级是所述通信等级的其中一个;获取所述患者对应的处于所述实时通信等级的用户设备。In a possible implementation manner, the controller is further configured to obtain the user equipment corresponding to the patient in the following manner: based on the real-time status type of the patient, query the real-time communication level corresponding to the real-time status type , wherein, for the patient, each communication level corresponds to one or more user equipment, and the user equipment corresponding to each communication level is manually configured, and the real-time communication level is one of the communication levels ; Obtain the user equipment corresponding to the patient at the real-time communication level.
在一种可能的实现方式中,所述控制器被进一步配置成采用如下方式向所述患者递送治疗:基于所述参数配置信息,通过所述治疗递送电路,控制所述推荐电极组合对应的两个电极向所述患者递送治疗。In a possible implementation manner, the controller is further configured to deliver treatment to the patient in the following manner: based on the parameter configuration information, through the treatment delivery circuit, control the two electrodes corresponding to the recommended electrode combination electrodes to deliver therapy to the patient.
在一种可能的实现方式中,所述控制器还被配置成:当所述推荐电极组合对应的当前时刻的实时特征信号和上一时刻的实时特征信号之间的相似度不大于预设相似度时,确定所述患者发生状态变化,并且记录所述当前时刻和所述推荐电极组合对应的当前时刻的实时特征信号。In a possible implementation manner, the controller is further configured to: when the similarity between the real-time characteristic signal at the current moment and the real-time characteristic signal at the previous moment corresponding to the recommended electrode combination is not greater than the preset similarity When the degree is higher, it is determined that the patient has a state change, and the real-time characteristic signal at the current moment corresponding to the recommended electrode combination is recorded.
在一种可能的实现方式中,所述控制器还被配置成:将所述患者的实时状态类型发送至程控设备,以使所述程控设备向所述患者对应的用户设备发送包含所述实时状态类型的状态变化提示信息;利用所述程控设备接收所述患者对应的用 户设备发送的对所述实时状态类型的确认操作或者修改操作,确认或者修改所述实时状态类型,再将所述实时状态类型和所述推荐电极组合对应的当前时刻的实时特征信号关联存储,作为训练数据,用于对所述状态分类模型进行更新。In a possible implementation manner, the controller is further configured to: send the real-time status type of the patient to the program-controlled device, so that the program-controlled device sends the real-time State change prompt information of the state type; use the program-controlled device to receive the confirmation operation or modification operation for the real-time state type sent by the user equipment corresponding to the patient, confirm or modify the real-time state type, and then update the real-time state type The state type and the real-time characteristic signal corresponding to the recommended electrode combination are associated and stored as training data for updating the state classification model.
在一种可能的实现方式中,所述控制器还被配置成:通过所述治疗递送电路,控制所述多个电极中的一个或多个向所述患者递送治疗;在递送治疗的过程中,通过所述感测电路,感测所述多个电极的电位。In a possible implementation manner, the controller is further configured to: control one or more of the plurality of electrodes to deliver therapy to the patient through the therapy delivery circuit; , sensing potentials of the plurality of electrodes through the sensing circuit.
第三方面,本申请提供一种植入式神经刺激系统,包括程控设备和上述任一项植入式神经刺激器。In a third aspect, the present application provides an implantable neurostimulator system, including a program-controlled device and any one of the above-mentioned implanted neurostimulators.
在一种可能的实现方式中,所述程控设备设置有触摸显示屏。In a possible implementation manner, the program-controlled device is provided with a touch display screen.
触摸显示屏可以方便患者对程控设备进行操作。The touch screen can facilitate the operation of the program-controlled equipment by the patient.
上述说明仅是本申请技术方案的概述,为了能够使本领域技术人员能够更清楚地了解本申请的技术手段,并可依照说明书的内容予以实施,以下以本申请的较佳实施例并配合详细附图说明如后。The above description is only an overview of the technical solutions of the present application. In order to enable those skilled in the art to understand the technical means of the present application more clearly and implement them according to the contents of the description, the preferred embodiments of the present application are used in conjunction with the detailed description below. The accompanying drawings are as follows.
附图说明Description of drawings
下面结合附图和实施例对本申请进一步说明。The application will be further described below in conjunction with the accompanying drawings and embodiments.
图1是现有技术中的一种参数调整方法的简要流程示意图;Fig. 1 is a brief flow diagram of a parameter adjustment method in the prior art;
图2是本申请实施例提供的一种参数调整方法的简要流程示意图;FIG. 2 is a schematic flowchart of a parameter adjustment method provided in the embodiment of the present application;
图3是本申请实施例提供的一种参数调整方法的流程示意图;FIG. 3 is a schematic flowchart of a parameter adjustment method provided in an embodiment of the present application;
图4是本申请实施例提供的另一种参数调整方法的部分流程示意图;Fig. 4 is a partial flowchart of another parameter adjustment method provided by the embodiment of the present application;
图5是本申请实施例提供的一种获取参数配置信息的流程示意图;FIG. 5 is a schematic flow diagram of obtaining parameter configuration information provided by an embodiment of the present application;
图6是本申请实施例提供的一种获取患者对应的用户设备的流程示意图;FIG. 6 is a schematic flow diagram of obtaining a user equipment corresponding to a patient provided by an embodiment of the present application;
图7是本申请实施例提供的又一种参数调整方法的部分流程示意图;Fig. 7 is a partial flowchart of another parameter adjustment method provided by the embodiment of the present application;
图8是本申请实施例提供的又一种参数调整方法的部分流程示意图;FIG. 8 is a partial flowchart of another parameter adjustment method provided by the embodiment of the present application;
图9是本申请实施例提供的又一种参数调整方法的部分流程示意图;FIG. 9 is a partial flowchart of another parameter adjustment method provided by the embodiment of the present application;
图10是本申请实施例提供的一种植入式神经刺激器的结构示意图;Fig. 10 is a schematic structural diagram of an implantable neurostimulator provided in an embodiment of the present application;
图11是本申请实施例提供的一种电子设备的结构示意图;Fig. 11 is a schematic structural diagram of an electronic device provided by an embodiment of the present application;
图12是本申请实施例提供的一种用于实现参数调整方法的程序产品的结构示意图。FIG. 12 is a schematic structural diagram of a program product for implementing a parameter adjustment 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,对本申请做进一步描述,需要说明的是,在不相冲突的前提下,以下描述的各实施例之间或各技术特征之间可以任意组合形成新的实施例。Below, the present application will be further described in conjunction with the accompanying drawings and specific implementation methods. It should be noted that, on the premise of not conflicting, the various embodiments described below or the technical features can be combined arbitrarily to form a new embodiment. .
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或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 "multiple" means two or more. "And/or" describes the association relationship of associated objects, indicating that there may be three types of relationships, for example, A and/or B, which can mean: A exists alone, A and B exist simultaneously, and B exists alone, where A, B can be singular or plural. The character "/" generally indicates that the contextual objects are an "or" relationship. "At least one of the following" or similar expressions refer to any combination of these items, including any combination of single or plural items. For example, at least one item (piece) of a, b or c can represent: a, b, c, a and b, a and c, b and c or a and b and c, wherein a, b and c can be It can be single or multiple. It should be noted that "at least one item (item)" can also be interpreted as "one item (item) or multiple items (item)".
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”的任何实施例或设计方案不应被解释为比其他实施例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, words such as "exemplary" or "for example" are used to mean an example, illustration or description. Any embodiment or design described herein as "exemplary" or "for example" is not to be construed as preferred or advantageous over other embodiments or designs. Rather, the use of words such as "exemplary" or "such as" is intended to present related concepts in a concrete manner.
下面,首先对本申请实施例的其中一个应用领域(即植入式神经刺激器)进行简单说明。In the following, one of the application fields (namely, implantable neurostimulator) of the embodiment of the present application will be briefly described first.
植入式神经刺激系统(一种植入式医疗系统)主要包括植入患者体内的刺激器(即植入式神经刺激器)以及设置于患者体外的程控设备。现有的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、植入式心脏电刺激系统(又称心脏起搏器)、植入式药物输注装置(Implantable Drug Delivery System,简称I DDS)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系统(Deep Brain Stimulation,简称DBS)、植入式脑皮层刺激系统(Cortical Nerve Stimulation,简称CNS)、植入式脊髓电刺激系统(Spinal Cord Stimulation,简称SCS)、植入式骶神经电刺激系统(S acral Nerve Stimulation,简称SNS)、植入式迷走神经电刺激系统(Vagus Nerve Stimulation,简称VNS)等。An implantable neurostimulator system (an implanted medical system) mainly includes a stimulator implanted in a patient (ie, an implanted neurostimulator) and a program-controlled device placed outside the patient's body. The existing neuromodulation technology mainly uses stereotaxic surgery to implant electrodes in specific structures (i.e., targets) in the body, and the stimulator implanted in the patient sends electrical pulses to the targets through the electrodes to regulate the corresponding neural structures and networks. Electrical activity and its function, thereby improving symptoms and relieving pain. Among them, the stimulator can be an implantable electrical nerve stimulation device, an implantable cardiac electrical stimulation system (also known as a cardiac pacemaker), an implantable drug infusion device (Implantable Drug Delivery System, referred to as IDDS) and a wire switch. any one of the connected devices. Implantable electrical nerve stimulation devices are, for example, Deep Brain Stimulation (DBS), Implantable Cortical Nerve Stimulation (CNS), Implantable Spinal Cord Stimulation , referred to as SCS), implanted sacral nerve stimulation system (Sacral Nerve Stimulation, referred to as SNS), implanted vagus nerve stimulation system (Vagus Nerve Stimulation, referred to as VNS) and so on.
刺激器可以包括IPG、延伸导线和电极导线,IPG(implantable pulse generator,植入式脉冲发生器)设置于患者体内,接收程控设备发送的程控指令,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递送一路或两路可控制的特定电刺激。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。电极导线通过多个电极触点,向体内组织的特定区域递送电刺激。刺激器设置有单侧或双侧的一路或多路电极导线,电极导线上设置有多个电极触点,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,电极触点可以以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 IPG, extension wires and electrode wires. The IPG (implantable pulse generator, implantable pulse generator) is set in the patient's body, receives the program control instructions sent by the program control device, and provides controllable stimulation to the tissues in the body relying on sealed batteries and circuits. Electrical stimulation energy, through implanted extension leads and electrode leads, delivers one or two controlled, specific electrical stimuli to specific areas of tissue in the body. The extension lead is used in conjunction with the IPG as a transmission medium for the electrical stimulation signal, and transmits the electrical stimulation signal generated by the IPG to the electrode lead. Electrode leads deliver electrical stimulation to specific areas of tissue in the body through multiple electrode contacts. The stimulator is provided with one or more electrode wires on one side or both sides, and a plurality of electrode contacts are arranged on the electrode wires, and the electrode contacts can be arranged uniformly or non-uniformly in the circumferential direction of the electrode wires. As an example, the electrode contacts may be arranged in an array of 4 rows and 3 columns (a total of 12 electrode contacts) in the circumferential direction of the electrode wire. Electrode contacts may include stimulation electrode contacts and/or collection electrode contacts. The electrode contacts can be in the shape of, for example, a sheet, a ring, or a dot.
在一些可能的实施方式中,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。本申请实施例对适用的疾病类型不做限定,其可以是脑深部刺激(DBS)、脊髓刺激(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但不限于:痉挛疾病(例如,癫痫)、疼痛、偏头痛、精神疾病(例如,重度抑郁症(MDD))、躁郁症、焦虑症、创伤后压力心理障碍症、轻郁症、强迫症(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、孤独症或其他神经学或精神科疾病和损害。In some possible 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 the patient's disease type is different, the stimulated site is generally different, the number of stimulation contacts used (single source or multi-source), one or more channels (single-channel or multi-channel) specific electrical stimulation signals The application and stimulus parameter data are also different. The embodiment of the present application does not limit the applicable disease types, which may be the applicable disease types for deep brain stimulation (DBS), spinal cord stimulation (SCS), pelvic stimulation, gastric stimulation, peripheral nerve stimulation, and functional electrical stimulation. Among the types of disorders that DBS can be used to treat or manage include, but are not limited to: spasticity disorders (e.g., epilepsy), pain, migraine, psychiatric disorders (e.g., major depressive disorder (MDD)), bipolar disorder, anxiety disorders, Post-traumatic stress disorder, hypodepression, obsessive-compulsive disorder (OCD), conduct disorder, mood disorder, memory disorder, mental status disorder, mobility disorder (eg, essential tremor or Parkinson's disease), Huntington's disease, Al Alzheimer's disease, drug addiction, autism, or other neurological or psychiatric conditions and impairments.
本申请实施例中,程控设备和刺激器建立程控连接时,可以利用程控设备调整刺激器的刺激参数(不同的刺激参数所对应的电刺激信号不同),也可以通过刺激器感测患者脑深部的生物电活动以采集得到电生理信号,并可以通过所采集到的电生理信号来继续调节刺激器的电刺激信号的刺激参数。In the embodiment of the present application, when the program-controlled device and the stimulator establish a program-controlled connection, the program-controlled device can be used to adjust the stimulation parameters of the stimulator (different stimulation parameters correspond to different electrical stimulation signals), and the stimulator can also be used to sense the deep brain of the patient. The bioelectric activity of the stimulator can be used to collect the electrophysiological signal, and the stimulation parameters of the electrical stimulation signal of the stimulator can be adjusted continuously through the collected electrophysiological signal.
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)、时序(例如可以是连续或者触发)、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)。Stimulation parameters can include at least one of the following: frequency (for example, the number of electrical stimulation pulse signals per unit time 1s, the unit is Hz), pulse width (the duration of each pulse, the unit is μs), amplitude (generally used Voltage expression, that is, the intensity of each pulse, the unit is V), timing (for example, it can be continuous or triggered), stimulation mode (including one or more of current mode, voltage mode, timed stimulation mode and cycle stimulation mode) , The upper and lower limits of the doctor's control (the range that can be adjusted by the doctor) and the upper and lower limits of the patient's control (the range that can be adjusted by the patient).
在一个具体应用场景中,可以在电流模式或者电压模式下对刺激器的各刺激参数进行调节。In a specific application scenario, various stimulation parameters of the stimulator can be adjusted in current mode or voltage mode.
程控设备可以是医生程控设备(即医生使用的程控设备)或者患者程控设备(即患者使用的程控设备)。医生程控设备例如可以是搭载有程控软件的平板电脑、笔记本电脑、台式计算机、手机等智能终端设备。患者程控设备例如可以是搭载有程控软件的平板电脑、笔记本电脑、台式计算机、手机等智能终端设备,患者程控设备还可以是其他具有程控功能的电子设备(例如是具有程控功能的充电器、数据采集设备)。The program-controlled device may be a doctor-programmed device (ie, a program-controlled device used by a doctor) or a patient-programmed device (ie, a program-controlled device used by a patient). The doctor's program-controlled device can be, for example, a tablet computer, a notebook computer, a desktop computer, a mobile phone and other smart terminal devices equipped with program-controlled software. The patient program-controlled device can be, for example, smart terminal devices such as tablet computers, notebook computers, desktop computers, and mobile phones equipped with program-controlled software, and the patient program-controlled device can also be other electronic devices with program-controlled functions (such as chargers with program-controlled functions, data collection device).
本申请实施例对医生程控设备和刺激器的数据交互不进行限制,当医生远程程控时,医生程控设备可以通过服务器、患者程控设备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,医生程控设备可以通过患者程控设备与刺激器进行数据交互,医生程控设备还可以直接与刺激器进行数据交互。The embodiment of the present application does not limit the data interaction between the doctor's program-controlled device and the stimulator. When the doctor remotely programs, the doctor's program-controlled device can perform data interaction with the stimulator through the server and the patient's program-controlled device. When the doctor performs program control with the patient face-to-face offline, the doctor's program-controlled device can interact with the stimulator through the patient's program-controlled device, and the doctor's program-controlled device can also directly interact with the stimulator.
在一些可选的实施方式中,患者程控设备可以包括(与服务器通信的)主机和(与刺激器通信的)子机,主机和子机可通信的连接。其中,医生程控设备可以通过3G/4G/5G网络与服务器进行数据交互,服务器可以通过3G/4G/5G网络与主机进行数据交互,主机可以通过蓝牙协议/WIFI协议/USB协议与子机进行数据交互,子机可以通过401MHz-406MHz工作频段/2.4GHz-2.48GHz工作频段与刺激器进行数据交互,医生程控设备可以通过401MHz-406MHz工作频段/2.4GHz-2.48GHz工作频段与刺激器直接进行数据交互。In some optional embodiments, the patient programmable device may include a host (communicating with the server) and a slave (communicating with the stimulator), the host and slave being communicatively connected. Among them, the doctor's program-controlled equipment can exchange data with the server through the 3G/4G/5G network, the server can exchange data with the host through the 3G/4G/5G network, and the host can exchange data with the slave through the Bluetooth protocol/WIFI protocol/USB protocol. Interaction, the sub-machine can exchange data with the stimulator through the 401MHz-406MHz working frequency band/2.4GHz-2.48GHz working frequency band, and the doctor's program-controlled equipment can directly exchange data with the stimulator through the 401MHz-406MHz working frequency band/2.4GHz-2.48GHz working frequency band interact.
参见图1,图1是现有技术中的一种参数调整方法的简要流程示意图。其中,患者状态类型的变化是基于实时地获取患者的实时状态类型并判断实时状态类型是否发生变化而进行判断的,在该过程中,需要实时地利用状态分类模型进行分类运算,占用的运算资源较大。Referring to FIG. 1 , FIG. 1 is a schematic flowchart of a parameter adjustment method in the prior art. Among them, the change of the patient’s state type is judged based on obtaining the real-time state type of the patient in real time and judging whether the real-time state type has changed. larger.
参见图2,图2是本申请实施例提供的一种参数调整方法的简要流程示意图。其中,患者状态类型的变化是先判断患者的实时特征信号是否发生变化,只有当实时特征信号发生变化后,才利用状态分类模型进行分类运算,得到患者的实时状态类型,在该过程中,无需实时地利用状态分类模型进行分类运算,而判断实时特征信号是否发生变化的运算量要远小于利用状态分类模型进行分类运算,因此,该过程占用的运算资源更小。Referring to FIG. 2 , FIG. 2 is a schematic flowchart of a parameter adjustment method provided in an embodiment of the present application. Among them, the change of the patient state type is to first judge whether the real-time characteristic signal of the patient changes. Only when the real-time characteristic signal changes, the state classification model is used for classification operation to obtain the real-time state type of the patient. In this process, there is no need to Real-time use of the state classification model for classification operations, and the amount of computation to determine whether the real-time feature signal has changed is much smaller than that of using the state classification model for classification operations, so the process occupies less computing resources.
继续参见图2,合并参见图3及图10,本申请实施例提供了一种植入式神经刺激器的参数调整方法,应用于植入式神经刺激器,所述植入式神经刺激器包括:多个电极101,所述多个电极101能够定位于患者脑内,以向所述患者递送治疗或者感测电活动;治疗递送电路102,所述治疗递送电路102可操作地耦接到所述多个电极101以向所述患者递送治疗;感测电路103,所述感测电路103可操作地耦接到所述多个电极101以感测电活动;控制器104,所述控制器104包括可操作地耦接到所述治疗递送电路102和所述感测电路103的处理电路系统;所述方法包括步骤S101~S107。Continue to refer to FIG. 2, and refer to FIG. 3 and FIG. 10 together. The embodiment of the present application provides a parameter adjustment method of an implantable neurostimulator, which is applied to an implanted neurostimulator. The implanted neurostimulator includes: a plurality of electrodes 101 capable of being positioned within the brain of a patient to deliver therapy or sense electrical activity to the patient; therapy delivery circuitry 102 operatively coupled to the a plurality of electrodes 101 to deliver therapy to the patient; a sensing circuit 103 operatively coupled to the plurality of electrodes 101 to sense electrical activity; a controller 104 the controller 104 Comprising processing circuitry operatively coupled to the therapy delivery circuit 102 and the sensing circuit 103; the method includes steps S101-S107.
其中,植入式神经刺激器是指通过产生电刺激,刺激患者体内的特定神经或肌肉,对患者的特定症状进行干预,从而治疗患者的装置,例如是,脑深部电刺激系统(Deep Brain Stimulation,简称DBS),植入式脑皮层刺激系统(Cortical Nerve Stimulation,简称CNS),植入式脊髓电刺激系统(Spinal Cord Stimulation,简称SCS),植入式骶神经电刺激系统(Sacral Nerve Stimulation,简称SNS),植入式迷走神经电刺激系统(Vagus Nerve Stimulation,简称VNS)等。刺激器的参数例如是频率(单位时间1s内的脉冲个数,单位为Hz)、脉宽(每个脉冲的持续时间,单位为μs)、和幅值(一般用电压表述,即每个脉冲的强度,单位为V)。在具体应用中,可以在电流模式或者电压模式下对刺激器的各参数进行调节。Among them, an implantable neurostimulator refers to a device that generates electrical stimulation to stimulate specific nerves or muscles in the patient's body to intervene in the patient's specific symptoms, such as the Deep Brain Stimulation System (Deep Brain Stimulation) , referred to as DBS), implanted cortical stimulation system (Cortical Nerve Stimulation, referred to as CNS), implanted spinal cord stimulation system (Spinal Cord Stimulation, referred to as SCS), implanted sacral nerve stimulation system (Sacral Nerve Stimulation, SNS for short), implantable vagus nerve stimulation system (Vagus Nerve Stimulation, VNS for short), etc. The parameters of the stimulator are, for example, frequency (number of pulses per unit time 1s, unit is Hz), pulse width (duration of each pulse, unit is μs), and amplitude (generally expressed in voltage, that is, each pulse The intensity of , the unit is V). In specific applications, various parameters of the stimulator can be adjusted in current mode or voltage mode.
本申请实施例中的患者,可以是帕金森患者,或者抑郁症患者、强迫症患者等精神疾病类患者,还可以是药物成瘾症患者或者戒毒人员。The patients in the embodiments of the present application may be patients with Parkinson's disease, or patients with mental illnesses such as depression patients and obsessive-compulsive disorder patients, or patients with drug addiction or drug addicts.
对于帕金森患者而言,最常采用的参数是130Hz、60μs和2-3V的电压。对于具有震颤症状的患者而言,大于100Hz的脉冲刺激才能有效,而低频率的刺激甚至会加重震颤。For Parkinson's patients, the most commonly used parameters are 130Hz, 60μs and a voltage of 2-3V. For patients with tremor symptoms, pulse stimulation greater than 100 Hz can be effective, and low frequency stimulation may even aggravate tremor.
步骤S101:通过所述感测电路,实时感测推荐电极组合对应的两个电极的电位,所述推荐电极组合包括所述多个电极的其中两个。Step S101: Sensing the potentials of two electrodes corresponding to a recommended electrode combination in real time through the sensing circuit, the recommended electrode combination including two of the plurality of electrodes.
步骤S102:基于所述推荐电极组合对应的两个电极的电位,计算所述推荐电极组合对应的两个电极之间的实时电压。Step S102: Based on the potentials of the two electrodes corresponding to the recommended electrode combination, calculate the real-time voltage between the two electrodes corresponding to the recommended electrode combination.
步骤S103:基于从预设时刻至当前时刻内所述推荐电极组合对应的两个电极之间的实时电压,获取所述推荐电极组合对应的当前时刻的实时特征信号,所述预设时刻在所述当前时刻之前。Step S103: Based on the real-time voltage between the two electrodes corresponding to the recommended electrode combination from the preset moment to the current moment, obtain the real-time characteristic signal at the current moment corresponding to the recommended electrode combination, and the preset moment is at the current moment. before the present moment.
步骤S104:将所述推荐电极组合对应的当前时刻的实时特征信号和上一时刻的实时特征信号输入相似度检测模型,得到所述推荐电极组合对应的当前时刻的实时特征信号和上一时刻的实时特征信号之间的相似度,所述相似度检测模型是预先训练得到的。Step S104: Input the real-time characteristic signal at the current moment and the real-time characteristic signal at the previous moment corresponding to the recommended electrode combination into the similarity detection model, and obtain the real-time characteristic signal at the current moment and the real-time characteristic signal at the previous moment corresponding to the recommended electrode combination The similarity between real-time feature signals, the similarity detection model is obtained by pre-training.
步骤S105:当所述推荐电极组合对应的当前时刻的实时特征信号和上一时刻的实时特征信号之间的相似度不大于预设相似度时,将所述推荐电极组合对应的当前时刻的实时特征信号输入状态分类模型,得到所述患者的实时状态类型,所述状态分类模型是预先训练得到的。所述推荐电极组合对应的当前时刻的实时特征信号和上一时刻的实时特征信号之间的相似度不大于预设相似度,表明当前时刻的实时特征信号与上一时刻的实时特征信号的相似度较低,与上一时刻相比实时特征信号相比发生较大变化;所述推荐电极组合对应的当前时刻的实时特征信号和上一时刻的实时特征信号之间的相似度大于预设相似度,表明当前时刻的实时特征信号与上一时刻的实时特征信号的相似度较高,与上一时刻相比实时特征信号相比并未发生较大变化。其中,预设相似度例如是80%、85%或者90%。Step S105: When the similarity between the real-time characteristic signal at the current moment corresponding to the recommended electrode combination and the real-time characteristic signal at the previous moment is not greater than the preset similarity, calculate the real-time characteristic signal at the current moment corresponding to the recommended electrode combination The characteristic signal is input into the state classification model to obtain the real-time state type of the patient, and the state classification model is obtained through pre-training. The similarity between the real-time characteristic signal at the current moment and the real-time characteristic signal at the previous moment corresponding to the recommended electrode combination is not greater than the preset similarity, indicating that the real-time characteristic signal at the current moment is similar to the real-time characteristic signal at the previous moment The degree of similarity between the real-time characteristic signal at the current moment corresponding to the recommended electrode combination and the real-time characteristic signal at the previous moment is greater than the preset similarity degree, indicating that the real-time characteristic signal at the current moment has a high similarity with the real-time characteristic signal at the previous moment, and the real-time characteristic signal has not changed significantly compared with the previous moment. Wherein, the preset similarity is, for example, 80%, 85% or 90%.
患者的状态类型可以是指患者的当前的活动状态的分类类型,例如可以包括以下至少一种:临睡前、起床后、吃药后、饭后、运动中以及发病中;或者,患者的状态类型可以是指患者的当前的情绪状态的分类类型,例如可以包括以下至少一种:正常、疲劳、沮丧、抑郁、开心等;对于不同的患者状态,最佳的治疗时的参数不同。The patient's state type may refer to the classification type of the patient's current activity state, for example, may include at least one of the following: before going to bed, after waking up, after taking medicine, after a meal, during exercise, and during an attack; or, the patient's state The type may refer to the classification type of the patient's current emotional state, for example, may include at least one of the following: normal, fatigue, depression, depression, happiness, etc.; for different patient states, the optimal treatment parameters are different.
其中,当所述推荐电极组合对应的当前时刻的实时特征信号和上一时刻的实时特征信号之间的相似度大于预设相似度时,可以不做任何处理。Wherein, when the similarity between the real-time characteristic signal at the current moment and the real-time characteristic signal at the previous moment corresponding to the recommended electrode combination is greater than the preset similarity, no processing may be performed.
步骤S106:基于所述患者的实时状态类型,获取参数配置信息。Step S106: Obtain parameter configuration information based on the real-time status type of the patient.
其中,参数配置信息是指用于指示向患者递送治疗时的参数的信息,其可以是预先存储于植入式神经刺激器中的配置信息,也可以是通过网络从云服务器获取的配置信息,也可以是手动录入的配置信息。Wherein, the parameter configuration information refers to the information used to indicate the parameters when delivering treatment to the patient, which may be the configuration information pre-stored in the implantable neurostimulator, or the configuration information acquired from the cloud server through the network, It can also be manually entered configuration information.
步骤S107:基于所述参数配置信息,通过所述治疗递送电路,控制所述多个电极中的一个或多个向所述患者递送治疗。Step S107: Based on the parameter configuration information, control one or more of the plurality of electrodes to deliver therapy to the patient through the therapy delivery circuit.
由此,利用推荐电极组合对应的电极的电位获得两个电极之间的电压,然后根据该电压获得实时特征信号,检测实时特征信号相比于上一时刻的相似度,当相似度不大于预设相似度时,对当前时刻的实时特征信号进行分类,得到实时状态类型,并根据该实时状态类型获取参数配置信息用以控制电极向患者递送治疗;相比于实时获取状态类型,实时获取相似度的运算量更低,节省了运算资源,提高了植入式神经刺激系统其余功能所对应的进程的运行速度。Thus, the potential of the electrode corresponding to the recommended electrode combination is used to obtain the voltage between the two electrodes, and then the real-time characteristic signal is obtained according to the voltage, and the similarity of the real-time characteristic signal compared with the previous moment is detected. When the similarity is not greater than the predetermined When setting the similarity, classify the real-time characteristic signals at the current moment to obtain the real-time state type, and obtain the parameter configuration information according to the real-time state type to control the electrode to deliver treatment to the patient; compared with the real-time state type, the real-time state is similar The computing load is lower, saving computing resources, and improving the running speed of processes corresponding to other functions of the implantable neurostimulation system.
参见图4,图4是本申请实施例提供的另一种参数调整方法的部分流程示意图。在一些可能的方式中,所述方法还可以包括步骤S108~S1012。Referring to FIG. 4 , FIG. 4 is a partial schematic flowchart of another parameter adjustment method provided by an embodiment of the present application. In some possible manners, the method may further include steps S108-S1012.
步骤S108:通过所述感测电路,感测所述多个电极的电位。Step S108: Sensing the potentials of the plurality of electrodes through the sensing circuit.
步骤S109:基于感测到的所述多个电极的电位,计算其中任意两个电极的电位的差值,得到所述任意两个电极之间的电压。Step S109: Based on the sensed potentials of the plurality of electrodes, calculate the difference between the potentials of any two of the electrodes to obtain the voltage between the any two electrodes.
步骤S110:基于预设时间范围以内的所述任意两个电极之间的电压,获取所述任意两个电极形成的电极组合对应的特征信号。Step S110: Based on the voltage between the any two electrodes within a preset time range, obtain the characteristic signal corresponding to the electrode combination formed by the any two electrodes.
步骤S111:基于每个电极组合对应的特征信号的信号强度、脉宽以及所述特征信号与期望信号的相似度中的一种或多种,获取每个电极组合对应的得分。Step S111: Obtain a score corresponding to each electrode combination based on one or more of the signal strength, pulse width, and similarity between the characteristic signal and the expected signal corresponding to each electrode combination.
步骤S112:基于所有电极组合对应的得分,将得分最高的电极组合作为所述推荐电极组合。Step S112: Based on the scores corresponding to all electrode combinations, use the electrode combination with the highest score as the recommended electrode combination.
由此,提供一种获取推荐电极组合的方法,基于预设时间范围内的任意两个电极之间的电压,获取特征信号,然后基于多个特征信号的一种或多种特征计算得分,将得分最高者作为推荐电极组合,所得到的推荐电极组合可以最大程度上反应患者的真实状态,使得基于该推荐电极组合所进行的参数调整更加准确。Therefore, a method for obtaining a recommended electrode combination is provided. Based on the voltage between any two electrodes within a preset time range, the characteristic signal is obtained, and then the score is calculated based on one or more characteristics of the plurality of characteristic signals. The one with the highest score is the recommended electrode combination, and the obtained recommended electrode combination can reflect the real state of the patient to the greatest extent, making the parameter adjustment based on the recommended electrode combination more accurate.
参见图5,图5是本申请实施例提供的一种获取参数配置信息的流程示意图。在一些可能的方式中,所述步骤S106可以包括步骤S201或者步骤S202:Referring to FIG. 5 , FIG. 5 is a schematic flowchart of obtaining parameter configuration information provided by an embodiment of the present application. In some possible manners, the step S106 may include step S201 or step S202:
步骤S201:将所述患者的实时状态类型输入参数配置模型,得到所述实时 状态类型对应的参数配置信息,所述参数配置模型是预先训练得到的;或者Step S201: Input the real-time state type of the patient into the parameter configuration model to obtain the parameter configuration information corresponding to the real-time state type, and the parameter configuration model is obtained through pre-training; or
步骤S202:将所述患者的实时状态类型发送至程控设备,以使程控设备将所述实时状态类型发送至所述患者对应的用户设备,以及接收所述程控设备发送的参数配置信息,所述参数配置信息是手动配置得到的。Step S202: Send the real-time state type of the patient to the program-controlled device, so that the program-controlled device sends the real-time state type to the user equipment corresponding to the patient, and receives the parameter configuration information sent by the program-controlled device, the The parameter configuration information is obtained through manual configuration.
由此,利用参数配置模型基于实时状态类型获取参数配置信息,能够快速、自动化地获取参数配置信息,及时地响应患者状态的变化,提高向患者递送治疗的效果;或者,利用手动配置基于实时状态类型获取参数配置信息,所得的参数配置信息准确,并且能够灵活地对特定患者进行参数调整,有助于提高治疗效果。Therefore, using the parameter configuration model to obtain parameter configuration information based on real-time status types can quickly and automatically obtain parameter configuration information, respond to changes in patient status in a timely manner, and improve the effect of delivering treatment to patients; or, use manual configuration based on real-time status Type to obtain parameter configuration information, the obtained parameter configuration information is accurate, and can flexibly adjust parameters for specific patients, which helps to improve the treatment effect.
参见图6,图6是本申请实施例提供的一种获取患者对应的用户设备的流程示意图。在一些可能的方式中,所述患者对应的用户设备的获取过程可以包括步骤S301~S302。Referring to FIG. 6 , FIG. 6 is a schematic flow chart of obtaining a user equipment corresponding to a patient provided by an embodiment of the present application. In some possible manners, the acquiring process of the user equipment corresponding to the patient may include steps S301-S302.
步骤S301:基于所述患者的实时状态类型,查询与所述实时状态类型相应的实时通信等级,其中,针对所述患者,每个通信等级对应一个或多个用户设备,且每个所述通信等级对应的用户设备是手动配置得到的,所述实时通信等级是所述通信等级的其中一个。Step S301: Based on the real-time status type of the patient, query the real-time communication level corresponding to the real-time status type, wherein, for the patient, each communication level corresponds to one or more user equipments, and each of the communication The user equipment corresponding to the level is manually configured, and the real-time communication level is one of the communication levels.
步骤S302:获取所述患者对应的处于所述实时通信等级的用户设备。Step S302: Obtain the user equipment at the real-time communication level corresponding to the patient.
其中,通信等级是指不同的用户设备所对应的分组的等级,例如,用户设备可以包括患者手机、患者平板电脑、患者家人手机、患者陪护人员手机、患者对应的医生的手机、患者对应的医生的平板电脑以及紧急救护人员的手机,通信等级例如是,将患者手机、患者平板电脑归类为第一等级,患者手机、患者平板电脑、患者家人手机、患者陪护人员手机归类为第二等级,患者手机、患者平板电脑、患者家人手机、患者陪护人员手机、患者对应的医生的手机、患者对应的医生的平板电脑归类为第三等级,患者手机、患者平板电脑、患者家人手机、患者陪护人员手机、患者对应的医生的手机、患者对应的医生的平板电脑、紧急救护人员的手机归类为第四等级。Among them, the communication level refers to the level of the group corresponding to different user equipment. For example, the user equipment may include the patient's mobile phone, the patient's tablet computer, the patient's family mobile phone, the patient's escort mobile phone, the patient's corresponding doctor's mobile phone, and the patient's corresponding doctor's mobile phone. For example, patient mobile phones and patient tablet computers are classified as the first level, and patient mobile phones, patient tablet computers, patient family mobile phones, and patient accompanying personnel mobile phones are classified as the second level. , the patient’s mobile phone, patient’s tablet computer, patient’s family mobile phone, patient’s accompanying person’s mobile phone, patient’s corresponding doctor’s mobile phone, patient’s corresponding doctor’s tablet computer are classified into the third level, patient’s mobile phone, patient’s tablet computer, patient’s family’s mobile phone, patient’s The mobile phones of accompanying personnel, mobile phones of doctors corresponding to patients, tablet computers of doctors corresponding to patients, and mobile phones of emergency rescue personnel are classified as the fourth level.
在一些应用场景中,患者A的实时状态类型确认为饭后,则将上述第一等级作为实时通信等级,患者A手机、患者A平板电脑为患者A对应的用户设备,此时患者A本人接收到实时状态类型为饭后;在另一些应用场景中,患者B的实时状态类型为服药后,则将上述第三等级作为实时通信等级,至少患者B对 应的医生的手机、患者B对应的医生的平板电脑为患者B对应的用户设备,至少患者B对应的医生接收到实时状态类型为服药后,便于医生对于患者B进行状态追踪和参数调整;在另一些应用场景中,患者C突然发病,患者C的实时状态类型为发病中,则将上述第四等级作为实时通信等级,此时,患者C家人手机、患者C陪护人员手机、患者C对应的医生的手机、患者C对应的医生的平板电脑以及紧急救护人员的手机均作为患者C对应的用户设备,患者C的家人、陪护人员、对应的医生以及紧急救护人员均可以及时了解到患者C正在发病,便于对患者C进行状态跟踪以及紧急救护。In some application scenarios, if the real-time status type of patient A is confirmed as after meal, the above-mentioned first level is used as the real-time communication level, and patient A’s mobile phone and patient A’s tablet are the corresponding user equipment of patient A. At this time, patient A himself receives The real-time status type is after meal; in other application scenarios, the real-time status type of patient B is after taking medicine, then the above-mentioned third level is used as the real-time communication level, at least the mobile phone of the doctor corresponding to patient B and the doctor corresponding to patient B The tablet computer of patient B is the user equipment corresponding to patient B. At least the doctor corresponding to patient B receives the real-time status type of taking medicine, which is convenient for the doctor to track the status and adjust the parameters of patient B; in other application scenarios, patient C suddenly becomes ill, If the real-time status type of patient C is onset, the above-mentioned fourth level is used as the real-time communication level. The computer and the mobile phone of the emergency rescue personnel are used as the user equipment corresponding to patient C. The family members, escorts, corresponding doctors and emergency rescue personnel of patient C can all know that patient C is sick in time, which is convenient for the status tracking and emergency management of patient C. ambulance.
将能够表征患者当前危险程度的实时状态类型与通信等级对应,能够根据当前患者的状态所对应的危险程度的不同,有选择地将患者的情况通知给特定人员或者与患者相关的全部人员,一方面在患者发生小问题时不打扰医生,避免加大医生工作量,浪费医疗资源,另一方面在患者发生重大问题时及时通知与患者相关的全部人员,能够及时发动救助力量。The real-time status type that can represent the current risk level of the patient corresponds to the communication level, and the patient's situation can be selectively notified to specific personnel or all personnel related to the patient according to the different risk levels corresponding to the current patient status. On the one hand, it will not disturb the doctor when the patient has a minor problem, avoiding increasing the workload of the doctor and wasting medical resources; on the other hand, when the patient has a major problem, it will promptly notify all the personnel related to the patient, so that rescue forces can be launched in time.
由此,基于实时状态类型确定该状态类型对应的实时通信等级,并基于该实时通信等级来获取患者对应的用户设备,能够针对患者不同的实时状态类型,获取不同的用户设备,使得当患者处于不同的状态时,相应的人员能够及时获知患者的状态。Therefore, based on the real-time state type, the real-time communication level corresponding to the state type is determined, and the user equipment corresponding to the patient is acquired based on the real-time communication level, so that different user equipment can be acquired for different real-time state types of the patient, so that when the patient is in In different states, the corresponding personnel can know the state of the patient in time.
在一些可能的方式中,所述步骤S107可以包括步骤S401。In some possible manners, the step S107 may include step S401.
步骤S401:基于所述参数配置信息,通过所述治疗递送电路,控制所述推荐电极组合对应的两个电极向所述患者递送治疗。Step S401: Based on the parameter configuration information, through the treatment delivery circuit, control the two electrodes corresponding to the recommended electrode combination to deliver treatment to the patient.
由此,基于参数配置信息基于推荐电极组合对应的电极来递送治疗,由于参数配置信息是基于推荐电极组合得到的,因此,基于推荐电极组合对应的电极来递送治疗会更加准确。Therefore, the treatment is delivered based on the electrodes corresponding to the recommended electrode combination based on the parameter configuration information. Since the parameter configuration information is obtained based on the recommended electrode combination, it is more accurate to deliver treatment based on the electrodes corresponding to the recommended electrode combination.
参见图7,图7是本申请实施例提供的又一种参数调整方法的部分流程示意图。在一些可能的方式中,所述方法还可以包括步骤S113。Referring to FIG. 7 , FIG. 7 is a partial schematic flowchart of another parameter adjustment method provided in an embodiment of the present application. In some possible manners, the method may further include step S113.
步骤S113:当所述推荐电极组合对应的当前时刻的实时特征信号和上一时刻的实时特征信号之间的相似度不大于预设相似度时,确定所述患者发生状态变化,并且记录所述当前时刻和所述推荐电极组合对应的当前时刻的实时特征信号。Step S113: When the similarity between the real-time characteristic signal at the current moment and the real-time characteristic signal at the previous moment corresponding to the recommended electrode combination is not greater than the preset similarity, determine that the patient has a state change, and record the The current moment and the real-time characteristic signal at the present moment corresponding to the recommended electrode combination.
其中,当所述推荐电极组合对应的当前时刻的实时特征信号和上一时刻的实 时特征信号之间的相似度大于预设相似度时,可以确定所述患者未发生状态变化,或者是,可以不做任何处理。Wherein, when the similarity between the real-time characteristic signal at the current moment and the real-time characteristic signal at the previous moment corresponding to the recommended electrode combination is greater than the preset similarity, it can be determined that no state change has occurred in the patient, or it can be Do nothing.
由此,利用相似度来确定患者状态的变化并记录当前时刻及其对应的实时特征信号,能够使得患者状态的变化以及对应的实时特征信号具有可追溯性,帮助医务人员对患者的状态进行回访和/或研究。Therefore, using the similarity to determine the change of the patient's state and recording the current moment and its corresponding real-time characteristic signal can make the change of the patient's state and the corresponding real-time characteristic signal traceable, and help medical staff to return to the patient's state and/or research.
参见图8,图8是本申请实施例提供的又一种参数调整方法的部分流程示意图。在一些可能的方式中,所述方法还可以包括步骤S114~S115。Referring to FIG. 8 , FIG. 8 is a partial flowchart of another parameter adjustment method provided by the embodiment of the present application. In some possible manners, the method may further include steps S114-S115.
步骤S114:将所述患者的实时状态类型发送至程控设备,以使所述程控设备向所述患者对应的用户设备发送包含所述实时状态类型的状态变化提示信息。Step S114: Send the real-time status type of the patient to the program-controlled device, so that the program-controlled device sends status change prompt information including the real-time status type to the user equipment corresponding to the patient.
步骤S115:利用所述程控设备接收所述患者对应的用户设备发送的对所述实时状态类型的确认操作或者修改操作,确认或者修改所述实时状态类型,再将所述实时状态类型和所述推荐电极组合对应的当前时刻的实时特征信号关联存储,作为训练数据,用于对所述状态分类模型进行更新。Step S115: Utilize the program-controlled device to receive the confirmation operation or modification operation on the real-time status type sent by the user equipment corresponding to the patient, confirm or modify the real-time status type, and then combine the real-time status type with the The real-time characteristic signal corresponding to the recommended electrode combination is associated and stored as training data for updating the state classification model.
在一些应用场景中,患者D服药后,患者D的实时状态类型确定为运动中,此时,将该实时状态类型发送至程控设备,并进一步地发送至患者D的手机,患者D识别出实时状态类型的错误,并利用其手机修改实时状态类型为服药后;然后患者D修改后的状态类型和当前的电极组合对应的实时特征信号被关联存储,依据关联存储的训练数据进行模型参数的更新,使得下次患者D服药后,其实时状态类型被正确地确定为服药后,其中,存储位置可以是患者D的程控设备中的存储介质,也可以是包含患者D的程控设备的网络结构中的云服务器;对模型参数的更新可以在患者D的程控设备中运行,也可以在云服务器中运行,并将更新后的模型参数发送至患者D的程控设备。In some application scenarios, after patient D takes the medicine, the real-time state type of patient D is determined to be in motion. At this time, the real-time state type is sent to the program-controlled device, and further sent to the mobile phone of patient D. Patient D recognizes the real-time The state type is wrong, and use his mobile phone to modify the real-time state type to after taking medicine; then the modified state type of patient D and the real-time characteristic signal corresponding to the current electrode combination are associated and stored, and the model parameters are updated according to the associated stored training data , so that the next time patient D takes the medicine, its real-time status type is correctly determined as after taking the medicine, wherein the storage location can be the storage medium in the program-controlled device of patient D, or it can be in the network structure including the program-controlled device of patient D The cloud server; the update of the model parameters can be run in the program-controlled device of patient D, and can also be run in the cloud server, and the updated model parameters are sent to the program-controlled device of patient D.
由此,将状态变化提示信息发送至用户设备,并接收用户的确认或修改操作,并将确认或修改后的实时状态类型与实时特征信号关联存储用以更新状态分类模型,能够通过手动对实时状态分类的确认和修改进一步地优化状态分类模型的识别准确度,进而最终提高参数调整的准确度。Thus, the status change prompt information is sent to the user equipment, and the confirmation or modification operation of the user is received, and the confirmed or modified real-time status type and the real-time characteristic signal are associated and stored to update the status classification model. The confirmation and modification of the state classification further optimizes the recognition accuracy of the state classification model, and finally improves the accuracy of parameter adjustment.
参见图9,图9是本申请实施例提供的又一种参数调整方法的部分流程示意图。在一些可能的方式中,所述方法还可以包括步骤S116~S117。Referring to FIG. 9 , FIG. 9 is a partial flowchart of another parameter adjustment method provided by the embodiment of the present application. In some possible manners, the method may further include steps S116-S117.
步骤S116:通过所述治疗递送电路,控制所述多个电极中的一个或多个向 所述患者递送治疗。Step S116: Control one or more of the plurality of electrodes to deliver therapy to the patient through the therapy delivery circuit.
步骤S117:在递送治疗的过程中,通过所述感测电路,感测所述多个电极的电位。Step S117: During the process of delivering the treatment, the potentials of the plurality of electrodes are sensed by the sensing circuit.
由此,在递送治疗的过程中,感测多个电极的电位,能够反映治疗过程中患者状态的变化,所进行的参数调整可以反映出治疗对于患者状态的影响,便于医务人员的调整及研究。Therefore, in the process of delivering treatment, sensing the potential of multiple electrodes can reflect the change of the patient's state during the treatment process, and the parameter adjustment can reflect the impact of the treatment on the patient's state, which is convenient for medical personnel to adjust and research .
参见图10,图10是本申请实施例提供的一种植入式神经刺激器的结构示意图。本申请实施例还提供一种植入式神经刺激器,包括:多个电极101,所述多个电极101能够定位于患者脑内,以向所述患者递送治疗或者感测电活动;治疗递送电路102,所述治疗递送电路102可操作地耦接到所述多个电极101以向所述患者递送治疗;感测电路103,所述感测电路103可操作地耦接到所述多个电极101以感测电活动;控制器104,所述控制器包括可操作地耦接到所述治疗递送电路102和所述感测电路103的处理电路系统,所述控制器104被配置成:通过所述感测电路,实时感测推荐电极组合对应的两个电极的电位,所述推荐电极组合包括所述多个电极的其中两个,基于所述推荐电极组合对应的两个电极的电位,计算所述推荐电极组合对应的两个电极之间的实时电压;基于从预设时刻至当前时刻内所述推荐电极组合对应的两个电极之间的实时电压,获取所述推荐电极组合对应的当前时刻的实时特征信号,所述预设时刻在所述当前时刻之前,将所述推荐电极组合对应的当前时刻的实时特征信号和上一时刻的实时特征信号输入相似度检测模型,得到所述推荐电极组合对应的当前时刻的实时特征信号和上一时刻的实时特征信号之间的相似度,所述相似度检测模型是预先训练得到的,当所述推荐电极组合对应的当前时刻的实时特征信号和上一时刻的实时特征信号之间的相似度不大于预设相似度时,将所述推荐电极组合对应的当前时刻的实时特征信号输入状态分类模型,得到所述患者的实时状态类型,所述状态分类模型是预先训练得到的,基于所述患者的实时状态类型,获取参数配置信息,基于所述参数配置信息,通过所述治疗递送电路,控制所述多个电极中的一个或多个向所述患者递送治疗。Referring to FIG. 10 , FIG. 10 is a schematic structural diagram of an implantable neurostimulator provided in an embodiment of the present application. The embodiment of the present application also provides an implantable neurostimulator, including: a plurality of electrodes 101, the plurality of electrodes 101 can be positioned in the patient's brain to deliver therapy or sense electrical activity to the patient; a therapy delivery circuit 102, the therapy delivery circuit 102 is operatively coupled to the plurality of electrodes 101 to deliver therapy to the patient; a sensing circuit 103, the sensing circuit 103 is operatively coupled to the plurality of electrodes 101 to sense electrical activity; a controller 104 comprising processing circuitry operatively coupled to the therapy delivery circuit 102 and the sensing circuit 103, the controller 104 being configured to: The sensing circuit senses the potentials of two electrodes corresponding to the recommended electrode combination in real time, and the recommended electrode combination includes two of the plurality of electrodes, based on the potentials of the two electrodes corresponding to the recommended electrode combination, Calculate the real-time voltage between the two electrodes corresponding to the recommended electrode combination; based on the real-time voltage between the two electrodes corresponding to the recommended electrode combination from the preset time to the current time, obtain the The real-time characteristic signal at the current moment, the preset time is before the current moment, and the real-time characteristic signal at the current moment corresponding to the recommended electrode combination and the real-time characteristic signal at the previous moment are input into the similarity detection model to obtain the The similarity between the real-time feature signal at the current moment corresponding to the recommended electrode combination and the real-time feature signal at the previous moment, the similarity detection model is obtained through pre-training, when the real-time feature signal at the current moment corresponding to the recommended electrode combination When the similarity between the signal and the real-time characteristic signal at the previous moment is not greater than the preset similarity, input the real-time characteristic signal at the current moment corresponding to the recommended electrode combination into the state classification model to obtain the real-time state type of the patient, The state classification model is pre-trained, and parameter configuration information is obtained based on the real-time state type of the patient, and based on the parameter configuration information, one or more of the plurality of electrodes is controlled through the treatment delivery circuit to deliver therapy to the patient.
在一些可能的方式中,所述控制器104还可以被配置成采用如下方式获取所述推荐电极组合:通过所述感测电路,感测所述多个电极的电位;基于感测到的 所述多个电极的电位,计算其中任意两个电极的电位的差值,得到所述任意两个电极之间的电压;基于预设时间范围以内的所述任意两个电极之间的电压,获取所述任意两个电极形成的电极组合对应的特征信号;基于每个电极组合对应的特征信号的信号强度、脉宽以及所述特征信号与期望信号的相似度中的一种或多种,获取每个电极组合对应的得分;基于所有电极组合对应的得分,将得分最高的电极组合作为所述推荐电极组合。In some possible manners, the controller 104 may also be configured to obtain the recommended electrode combination in the following manner: through the sensing circuit, sensing the potentials of the plurality of electrodes; The potentials of the plurality of electrodes are calculated, and the difference between the potentials of any two electrodes is calculated to obtain the voltage between the two electrodes; based on the voltage between the two electrodes within the preset time range, the obtained The characteristic signal corresponding to the electrode combination formed by any two electrodes; based on one or more of the signal strength, pulse width and similarity between the characteristic signal and the expected signal of the characteristic signal corresponding to each electrode combination, obtain The score corresponding to each electrode combination; based on the scores corresponding to all electrode combinations, the electrode combination with the highest score is used as the recommended electrode combination.
在一些可能的方式中,所述控制器104可以被进一步配置成采用如下方式获取所述参数配置信息:将所述患者的实时状态类型输入参数配置模型,得到所述实时状态类型对应的参数配置信息,所述参数配置模型是预先训练得到的;或者In some possible manners, the controller 104 may be further configured to obtain the parameter configuration information in the following manner: input the real-time state type of the patient into the parameter configuration model to obtain the parameter configuration corresponding to the real-time state type information, the parameter configuration model is pre-trained; or
将所述患者的实时状态类型发送至程控设备,以使程控设备将所述实时状态类型发送至所述患者对应的用户设备,以及接收所述程控设备发送的参数配置信息,所述参数配置信息是手动配置得到的。Sending the real-time state type of the patient to the program-controlled device, so that the program-controlled device sends the real-time state type to the user equipment corresponding to the patient, and receives parameter configuration information sent by the program-controlled device, the parameter configuration information It is manually configured.
在一些可能的方式中,所述控制器104还可以被配置成采用如下方式获取所述患者对应的用户设备:基于所述患者的实时状态类型,查询与所述实时状态类型相应的实时通信等级,其中,针对所述患者,每个通信等级对应一个或多个用户设备,且每个所述通信等级对应的用户设备是手动配置得到的,所述实时通信等级是所述通信等级的其中一个;获取所述患者对应的处于所述实时通信等级的用户设备。In some possible manners, the controller 104 may also be configured to obtain the user equipment corresponding to the patient in the following manner: based on the real-time status type of the patient, query the real-time communication level corresponding to the real-time status type , wherein, for the patient, each communication level corresponds to one or more user equipment, and the user equipment corresponding to each communication level is manually configured, and the real-time communication level is one of the communication levels ; Obtain the user equipment corresponding to the patient at the real-time communication level.
在一些可能的方式中,所述控制器104可以被进一步配置成采用如下方式向所述患者递送治疗:基于所述参数配置信息,通过所述治疗递送电路,控制所述推荐电极组合对应的两个电极向所述患者递送治疗。In some possible manners, the controller 104 may be further configured to deliver therapy to the patient in the following manner: based on the parameter configuration information, through the therapy delivery circuit, control the two electrodes corresponding to the recommended electrode combination electrodes to deliver therapy to the patient.
在一些可能的方式中,所述控制器104还可以被配置成:当所述推荐电极组合对应的当前时刻的实时特征信号和上一时刻的实时特征信号之间的相似度不大于预设相似度时,确定所述患者发生状态变化,并且记录所述当前时刻和所述推荐电极组合对应的当前时刻的实时特征信号。In some possible manners, the controller 104 may also be configured to: when the similarity between the real-time characteristic signal at the current moment and the real-time characteristic signal at the previous moment corresponding to the recommended electrode combination is not greater than the preset similarity When the degree is higher, it is determined that the patient has a state change, and the real-time characteristic signal at the current moment corresponding to the recommended electrode combination is recorded.
在一些可能的方式中,所述控制器104还可以被配置成:将所述患者的实时状态类型发送至程控设备,以使所述程控设备向所述患者对应的用户设备发送包含所述实时状态类型的状态变化提示信息;利用所述程控设备接收所述患者对应的用户设备发送的对所述实时状态类型的确认操作或者修改操作,确认或者修改 所述实时状态类型,再将所述实时状态类型和所述推荐电极组合对应的当前时刻的实时特征信号关联存储,作为训练数据,用于对所述状态分类模型进行更新。In some possible manners, the controller 104 may also be configured to: send the real-time status type of the patient to the program-controlled device, so that the program-controlled device sends the real-time State change prompt information of the state type; use the program-controlled device to receive the confirmation operation or modification operation for the real-time state type sent by the user equipment corresponding to the patient, confirm or modify the real-time state type, and then update the real-time state type The state type and the real-time characteristic signal corresponding to the recommended electrode combination are associated and stored as training data for updating the state classification model.
在一些可能的方式中,所述控制器104还可以被配置成:通过所述治疗递送电路,控制所述多个电极中的一个或多个向所述患者递送治疗;在递送治疗的过程中,通过所述感测电路,感测所述多个电极的电位。In some possible ways, the controller 104 can also be configured to: control one or more of the plurality of electrodes to deliver therapy to the patient through the therapy delivery circuit; , sensing potentials of the plurality of electrodes through the sensing circuit.
本申请实施例还提供一种植入式神经刺激系统,包括程控设备和上述任一项植入式神经刺激器。An embodiment of the present application also provides an implantable neurostimulator system, including a program-controlled device and any one of the above-mentioned implanted neurostimulators.
在一些可能的方式中,所述程控设备可以设置有触摸显示屏。In some possible manners, the program-controlled device may be provided with a touch screen.
参见图11,图11是本申请实施例提供的一种电子设备的结构示意图。本申请实施例还提供了一种电子设备200,电子设备200包括至少一个存储器210、至少一个处理器220以及连接不同平台系统的总线230。Referring to FIG. 11 , FIG. 11 is a schematic structural diagram of an electronic device provided by an embodiment of the present application. The embodiment of the present application also provides an electronic device 200, and the electronic device 200 includes 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(RAM)211和/或高速缓存存储器212,还可以进一步包括只读存储器(ROM)213。 Memory 210 may include readable media in the form of volatile memory, such as random access memory (RAM) 211 and/or cache memory 212 , and may further include read only memory (ROM) 213 .
其中,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执行本申请实施例中参数调整方法的步骤,其具体实现方式与上述参数调整方法的实施例中记载的实施方式、所达到的技术效果一致,部分内容不再赘述。Wherein, the memory 210 also stores a computer program, and the computer program can be executed by the processor 220, so that the processor 220 executes the steps of the parameter adjustment method in the embodiment of the present application. The implementation mode and the achieved technical effect are the same, and part of 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包括但不限于:操作系统、一个或者多个应用程序、其它程序模块以及程序数据,这些示例中的每一个或某种组合中可能包括网络环境的实现。 Memory 210 may also include utility 214 having at least one program module 215 including, but not limited to, an operating system, one or more application programs, other program modules, and program data, examples of each or Implementations of network environments may be included in some combination.
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 .
总线230可以为表示几类总线结构中的一种或多种,包括存储器总线或者存储器控制器104、外围总线、图形加速端口、处理器或者使用多种总线结构中的任意总线结构的局域总线。 Bus 230 may be representative of one or more of several types of bus structures, including a memory bus or memory controller 104, a peripheral bus, an accelerated graphics port, a processor, or a local bus using any of a variety of bus structures. .
电子设备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电子设备200交互的设备通信,和/或与使得该电子设备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,电子设备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(L AN),广域网(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与电子设备200的其它模块通信。应当明白,尽管图中未示出,可以结合电子设备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、RAID系统、磁带驱动器以及数据备份存储平台等。The electronic device 200 can also communicate with one or more external devices 240 such as keyboards, pointing devices, Bluetooth devices, etc., and can also communicate with one or more devices capable of interacting with the electronic device 200, and/or communicate with the electronic device 200 200 is capable of communicating with any device (eg, router, modem, etc.) that communicates with one or more other computing devices. Such communication may occur through input-output interface 250 . Moreover, the electronic device 200 can also communicate with one or more networks (such as a local area network (LAN), a wide area network (WAN) and/or a public network such as the Internet) through the network adapter 260 . The network adapter 260 can communicate with other modules of the electronic device 200 through the bus 230 . It should be appreciated that although not shown, other hardware and/or software modules may be used in conjunction with electronic device 200, including but not limited to: microcode, device drivers, redundant processors, external disk drive arrays, RAID systems, tape drives And data backup storage platform, etc.
本申请实施例还提供了一种计算机可读存储介质,该计算机可读存储介质用于存储计算机程序,所述计算机程序被执行时实现本申请实施例中参数调整方法的步骤,其具体实现方式与上述参数调整方法的实施例中记载的实施方式、所达到的技术效果一致,部分内容不再赘述。The embodiment of the present application also provides a computer-readable storage medium, which is used to store a computer program. When the computer program is executed, the steps of the parameter adjustment method in the embodiment of the present application are realized. The specific implementation method The implementation mode and the achieved technical effect are consistent with those described in the above-mentioned embodiment of the parameter adjustment method, and part of the content will not be repeated here.
图12示出了本实施例提供的用于实现上述植入式神经刺激器的程序产品300,其可以采用便携式紧凑盘只读存储器(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,本发明的程序产品300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系统、装置或者器件使用或者与其结合使用。程序产品300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、或半导体的系统、装置或器件,或者任意以上的组合。可读存储介质的更具体的例子(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、随机存取存储器(RAM)、只读存储器(ROM)、可擦式可编程只读存储器(EPROM或闪存)、光纤、便携式紧凑盘只读存储器(CD-ROM)、光存储器件、磁存储器件、或者上述的任意合适的组合。Fig. 12 shows the program product 300 for realizing the above-mentioned implantable neurostimulator provided by this embodiment, which can adopt a portable compact disk read-only memory (CD-ROM) and include program codes, and can be installed on the terminal equipment, For example running on a personal computer. However, the program product 300 of the present invention is not limited thereto. In this application, a readable storage medium may be any tangible medium containing or storing a program, and the program may be used by or in combination with an instruction execution system, device or device. Program product 300 may utilize any combination of one or more readable media. The readable medium may be a readable signal medium or a readable storage medium. The readable storage medium may be, for example, but not limited to, an electrical, magnetic, optical, electromagnetic, infrared, or semiconductor system, device, or device, or any combination thereof. More specific examples (non-exhaustive list) of readable storage media include: electrical connection with one or more conductors, portable disk, hard disk, random access memory (RAM), read only memory (ROM), erasable programmable read-only memory (EPROM or flash memory), optical fiber, portable compact disk read-only memory (CD-ROM), optical storage devices, magnetic storage devices, or any suitable combination of the foregoing.
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系统、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、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发明操作的程序代码,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,包括局域网(LAN)或广域网(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 carrying readable program code in baseband or as part of a carrier wave traveling as part of a data signal. Such propagated data signals may take many forms, including but not limited to electromagnetic signals, optical signals, or any suitable combination of the foregoing. A readable storage medium may also be any readable medium that can transmit, propagate, or transport a program for use by or in connection with an instruction execution system, apparatus, or device. The program code contained on the readable storage medium can be transmitted by any appropriate medium, including but not limited to wireless, cable, optical cable, RF, etc., or any suitable combination of the above. The program codes for performing the operations of the present invention can be written in any combination of one or more programming languages, and the programming languages include object-oriented programming languages such as Java, C++, etc., and also include conventional procedural programming languages A programming language such as C or similar. The program code may execute entirely on the user's computing device, partly on the user's device, as a stand-alone software package, partly on the user's computing device and partly on a remote computing device, or entirely on the remote computing device or server to execute. In cases involving a remote computing device, the remote computing device may be connected to the user computing device through any kind of network, including a local area network (LAN) or a wide area network (WAN), or may be connected to an external computing device (e.g., using an Internet service provider). business to connect via the Internet).
本申请从使用目的上,效能上,进步及新颖性等观点进行阐述,本申请以上的说明书及说明书附图,仅为本申请的较佳实施例而已,并非以此局限本申请,因此,凡一切与本申请构造,装置,特征等近似、雷同的,即凡依本申请专利申请范围所作的等同替换或修饰等,皆应属本申请的专利申请保护的范围之内。This application is elaborated from the perspectives of purpose of use, performance, progress and novelty. The above description and accompanying drawings of this application are only preferred embodiments of this application, and are not intended to limit this application. Therefore, all All structures, devices, features, etc. that are similar or identical to those of the present application, that is, all equivalent replacements or modifications made according to the scope of the patent application of the present application, shall fall within the scope of protection of the patent application of the present application.

Claims (10)

  1. 一种植入式神经刺激器,包括:An implantable neurostimulator comprising:
    多个电极,所述多个电极能够定位于患者脑内,以向所述患者递送治疗或者感测电活动;a plurality of electrodes positionable within the patient's brain to deliver therapy or sense electrical activity to the patient;
    治疗递送电路,所述治疗递送电路可操作地耦接到所述多个电极以向所述患者递送治疗;therapy delivery circuitry operatively coupled to the plurality of electrodes to deliver therapy to the patient;
    感测电路,所述感测电路可操作地耦接到所述多个电极以感测电活动;sensing circuitry operatively coupled to the plurality of electrodes to sense electrical activity;
    控制器,所述控制器包括可操作地耦接到所述治疗递送电路和所述感测电路的处理电路系统,所述控制器被配置成:a controller comprising processing circuitry operably coupled to the therapy delivery circuit and the sensing circuit, the controller configured to:
    通过所述感测电路,实时感测推荐电极组合对应的两个电极的电位,所述推荐电极组合包括所述多个电极的其中两个,Through the sensing circuit, the potentials of the two electrodes corresponding to the recommended electrode combination are sensed in real time, and the recommended electrode combination includes two of the plurality of electrodes,
    基于所述推荐电极组合对应的两个电极的电位,计算所述推荐电极组合对应的两个电极之间的实时电压;calculating the real-time voltage between the two electrodes corresponding to the recommended electrode combination based on the potentials of the two electrodes corresponding to the recommended electrode combination;
    基于从预设时刻至当前时刻内所述推荐电极组合对应的两个电极之间的实时电压,获取所述推荐电极组合对应的当前时刻的实时特征信号,所述预设时刻在所述当前时刻之前,Based on the real-time voltage between the two electrodes corresponding to the recommended electrode combination from the preset moment to the current moment, the real-time characteristic signal at the current moment corresponding to the recommended electrode combination is obtained, and the preset moment is at the current moment Before,
    将所述推荐电极组合对应的当前时刻的实时特征信号和上一时刻的实时特征信号输入相似度检测模型,得到所述推荐电极组合对应的当前时刻的实时特征信号和上一时刻的实时特征信号之间的相似度,所述相似度检测模型是预先训练得到的,Input the real-time characteristic signal at the current moment and the real-time characteristic signal at the previous moment corresponding to the recommended electrode combination into the similarity detection model, and obtain the real-time characteristic signal at the current moment and the real-time characteristic signal at the previous moment corresponding to the recommended electrode combination The similarity between, the similarity detection model is pre-trained,
    当所述推荐电极组合对应的当前时刻的实时特征信号和上一时刻的实时特征信号之间的相似度不大于预设相似度时,将所述推荐电极组合对应的当前时刻的实时特征信号输入状态分类模型,得到所述患者的实时状态类型,所述状态分类模型是预先训练得到的,When the similarity between the real-time characteristic signal at the current moment corresponding to the recommended electrode combination and the real-time characteristic signal at the previous moment is not greater than the preset similarity, input the real-time characteristic signal at the current moment corresponding to the recommended electrode combination A state classification model to obtain the real-time state type of the patient, the state classification model is pre-trained,
    基于所述患者的实时状态类型,获取参数配置信息,Obtain parameter configuration information based on the real-time status type of the patient,
    基于所述参数配置信息,通过所述治疗递送电路,控制所述多个电极中的一个或多个向所述患者递送治疗。One or more of the plurality of electrodes is controlled to deliver therapy to the patient via the therapy delivery circuit based on the parameter configuration information.
  2. 根据权利要求1所述的植入式神经刺激器,其中,所述控制器还被配置成采用如下方式获取所述推荐电极组合:The implantable neurostimulator according to claim 1, wherein the controller is further configured to obtain the recommended electrode combination in the following manner:
    通过所述感测电路,感测所述多个电极的电位;sensing potentials of the plurality of electrodes through the sensing circuit;
    基于感测到的所述多个电极的电位,计算其中任意两个电极的电位的差值,得到所述任意两个电极之间的电压;Based on the sensed potentials of the plurality of electrodes, calculating the difference between the potentials of any two electrodes, to obtain the voltage between any two electrodes;
    基于预设时间范围以内的所述任意两个电极之间的电压,获取所述任意两个电极形成的电极组合对应的特征信号;Obtaining a characteristic signal corresponding to an electrode combination formed by any two electrodes based on the voltage between any two electrodes within a preset time range;
    基于每个电极组合对应的特征信号的信号强度、脉宽以及所述特征信号与期望信号的相似度中的一种或多种,获取每个电极组合对应的得分;Obtain a score corresponding to each electrode combination based on one or more of the signal strength, pulse width, and similarity between the characteristic signal and the expected signal corresponding to each electrode combination;
    基于所有电极组合对应的得分,将得分最高的电极组合作为所述推荐电极组合。Based on the scores corresponding to all electrode combinations, the electrode combination with the highest score is used as the recommended electrode combination.
  3. 根据权利要求1所述的植入式神经刺激器,其中,所述控制器被进一步配置成采用如下方式获取所述参数配置信息:The implantable neural stimulator according to claim 1, wherein the controller is further configured to obtain the parameter configuration information in the following manner:
    将所述患者的实时状态类型输入参数配置模型,得到所述实时状态类型对应的参数配置信息,所述参数配置模型是预先训练得到的;或者Inputting the real-time state type of the patient into a parameter configuration model to obtain parameter configuration information corresponding to the real-time state type, and the parameter configuration model is obtained through pre-training; or
    将所述患者的实时状态类型发送至程控设备,以使程控设备将所述实时状态类型发送至所述患者对应的用户设备,以及接收所述程控设备发送的参数配置信息,所述参数配置信息是手动配置得到的。Sending the real-time state type of the patient to the program-controlled device, so that the program-controlled device sends the real-time state type to the user equipment corresponding to the patient, and receives parameter configuration information sent by the program-controlled device, the parameter configuration information It is manually configured.
  4. 根据权利要求3所述的植入式神经刺激器,其中,所述控制器还被配置成采用如下方式获取所述患者对应的用户设备:The implantable neurostimulator according to claim 3, wherein the controller is further configured to acquire the corresponding user equipment of the patient in the following manner:
    基于所述患者的实时状态类型,查询与所述实时状态类型相应的实时通信等级,其中,针对所述患者,每个通信等级对应一个或多个用户设备,且每个所述通信等级对应的用户设备是手动配置得到的,所述实时通信等级是所述通信等级的其中一个;Based on the real-time status type of the patient, query the real-time communication level corresponding to the real-time status type, wherein, for the patient, each communication level corresponds to one or more user equipments, and each communication level corresponds to The user equipment is manually configured, and the real-time communication level is one of the communication levels;
    获取所述患者对应的处于所述实时通信等级的用户设备。The user equipment corresponding to the patient at the real-time communication level is acquired.
  5. 根据权利要求1所述的植入式神经刺激器,其中,所述控制器被进一步配置成采用如下方式向所述患者递送治疗:The implantable neurostimulator of claim 1 , wherein the controller is further configured to deliver therapy to the patient by:
    基于所述参数配置信息,通过所述治疗递送电路,控制所述推荐电极组合对 应的两个电极向所述患者递送治疗。Based on the parameter configuration information, through the therapy delivery circuit, two electrodes corresponding to the recommended electrode combination are controlled to deliver therapy to the patient.
  6. 根据权利要求1所述的植入式神经刺激器,其中,所述控制器还被配置成:The implantable neurostimulator of claim 1, wherein the controller is further configured to:
    当所述推荐电极组合对应的当前时刻的实时特征信号和上一时刻的实时特征信号之间的相似度不大于预设相似度时,确定所述患者发生状态变化,并且记录所述当前时刻和所述推荐电极组合对应的当前时刻的实时特征信号。When the similarity between the real-time characteristic signal at the current moment and the real-time characteristic signal at the previous moment corresponding to the recommended electrode combination is not greater than the preset similarity, it is determined that the patient has a state change, and the current moment and the real-time characteristic signal are recorded. The real-time feature signal at the current moment corresponding to the recommended electrode combination.
  7. 根据权利要求6所述的植入式神经刺激器,其中,所述控制器还被配置成:The implantable neurostimulator of claim 6, wherein the controller is further configured to:
    将所述患者的实时状态类型发送至程控设备,以使所述程控设备向所述患者对应的用户设备发送包含所述实时状态类型的状态变化提示信息;Sending the real-time status type of the patient to the program-controlled device, so that the program-controlled device sends the status change prompt information including the real-time status type to the user equipment corresponding to the patient;
    利用所述程控设备接收所述患者对应的用户设备发送的对所述实时状态类型的确认操作或者修改操作,确认或者修改所述实时状态类型,再将所述实时状态类型和所述推荐电极组合对应的当前时刻的实时特征信号关联存储,作为训练数据,用于对所述状态分类模型进行更新。Utilize the program-controlled device to receive the confirmation operation or modification operation on the real-time status type sent by the user equipment corresponding to the patient, confirm or modify the real-time status type, and then combine the real-time status type with the recommended electrode Corresponding real-time feature signals at the current moment are associated and stored as training data for updating the state classification model.
  8. 根据权利要求1所述的植入式神经刺激器,其中,所述控制器还被配置成采用如下方式感测所述多个电极的电位:The implantable neurostimulator of claim 1, wherein the controller is further configured to sense the potential of the plurality of electrodes in the following manner:
    通过所述治疗递送电路,控制所述多个电极中的一个或多个向所述患者递送治疗;controlling one or more of the plurality of electrodes to deliver therapy to the patient via the therapy delivery circuit;
    在递送治疗的过程中,通过所述感测电路,感测所述多个电极的电位。During delivery of therapy, the electrical potential of the plurality of electrodes is sensed by the sensing circuit.
  9. 一种植入式神经刺激系统,包括程控设备和权利要求1所述的植入式神经刺激器。An implantable nerve stimulation system, comprising a program-controlled device and the implantable nerve stimulator according to claim 1.
  10. 根据权利要求9所述的植入式神经刺激系统,其中,所述程控设备设置有触摸显示屏。The implantable neural stimulation system according to claim 9, wherein the programmable device is provided with a touch display screen.
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