WO2022166684A1 - 用于植入式电刺激装置的自适应闭环检测方法及系统 - Google Patents

用于植入式电刺激装置的自适应闭环检测方法及系统 Download PDF

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WO2022166684A1
WO2022166684A1 PCT/CN2022/073770 CN2022073770W WO2022166684A1 WO 2022166684 A1 WO2022166684 A1 WO 2022166684A1 CN 2022073770 W CN2022073770 W CN 2022073770W WO 2022166684 A1 WO2022166684 A1 WO 2022166684A1
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detection
detection rate
rate
threshold
expected
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French (fr)
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曹鹏
林婷
吴承瀚
陈新蕾
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杭州诺为医疗技术有限公司
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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
    • A61N1/3606Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36064Epilepsy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/40Detecting, measuring or recording for evaluating the nervous system
    • A61B5/4076Diagnosing or monitoring particular conditions of the nervous system
    • A61B5/4094Diagnosing or monitoring seizure diseases, e.g. epilepsy
    • 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
    • A61N1/3606Implantable 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
    • A61N1/36125Details 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
    • A61N1/36135Control systems using physiological parameters

Definitions

  • This document relates to the technical field of medical equipment, and in particular, to an adaptive closed-loop detection method and system for implantable electrical stimulation devices.
  • implantable medical systems have been widely used in clinical medicine, including implantable electrical stimulation systems, implantable drug injection systems, and the like.
  • the implantable electrical stimulation system includes an implantable nerve electrical stimulation system and an implantable cardiac electrical stimulation system.
  • the implantable electrical nerve stimulation system mainly includes an implanted electrical pulse generator, a stimulation electrode and an external controller.
  • the electrical stimulation pulses generated by the implantable electrical pulse generator are transmitted to the stimulation electrodes, and the stimulation electrodes are transmitted to specific neural targets for electrical stimulation, so that conditions such as Parkinson's and epilepsy can be treated.
  • the implantable electrical pulse generator collects physiological signals through the acquisition circuit before performing electrical stimulation on the nerve target to treat the condition, so as to determine whether the patient has or is about to have the disease according to the sampled signal. If the disease has occurred or is about to occur, the implantable electrical pulse generator is adjusted to send electrical stimulation pulses to the stimulating electrodes, so as to intervene or intervene in advance to prevent the occurrence of Parkinson's, epilepsy and other diseases.
  • the current implantable electrical stimulation device has a low detection rate for Parkinson's, epilepsy and other diseases, resulting in the inability to intervene accurately and timely for the diseases. How to improve the detection rate of signal detection, accurately detect the disease, and intervene in time for the disease has become a technical problem that needs to be solved urgently.
  • the purpose of one or more embodiments of this specification is to provide an adaptive closed-loop detection method and system for an implantable electrical stimulation device, which can improve the detection rate of signal detection, accurately detect diseases, and timely detect diseases. intervention.
  • an adaptive closed-loop detection method for an implantable electrical stimulation device comprising: setting a desired detection rate and an initial detection threshold; based on the initial detection threshold, within a currently set time period Perform closed-loop detection of the sampled signal to obtain the current detection rate; compare the current detection rate with the expected detection rate; if the current detection rate is not within the set range of the expected detection rate, then Adaptively modify the initial detection threshold and continue to perform closed-loop detection of the sampled signal until the current detection rate is within the set range of the expected detection rate; take the newly modified initial detection threshold as Target detection threshold.
  • an implantable electrical stimulation device comprising: a setting module for setting a desired detection rate and an initial detection threshold; a detection module for setting a current set time period based on the initial detection threshold Perform closed-loop detection of the sampled signal inside to obtain the current detection rate; a comparison module is used to compare the current detection rate with the expected detection rate; and the detection module is also used for if the current detection rate If the detection rate is not within the set range of the expected detection rate, the initial detection threshold is adaptively modified and the closed-loop detection of the sampled signal is continued until the current detection rate is within the set range of the expected detection rate.
  • the threshold acquisition module is further configured to use the newly modified initial detection threshold as the target detection threshold.
  • an implantable electrical stimulation system comprising an external device and an implantable electrical stimulation device as described above, the external device being communicatively connected to the implantable electrical stimulation device.
  • a storage medium for computer-readable storage, the storage medium stores one or more programs, and when the one or more programs can be executed by one or more processors, the above-mentioned implementation is achieved The steps of the adaptive closed-loop detection method described in this paper.
  • an adaptive closed-loop detection method for an implantable electrical stimulation device provided by the present application, after setting the expected detection rate and the initial detection threshold, Based on the initial detection threshold, the sampling signal closed-loop detection is performed within the current set time period, and the current detection rate is obtained after the current set time period ends. Next, compare the current detection rate with the expected detection rate; if the current detection rate is not within the set range of the expected detection rate, the initial detection threshold will be adaptively modified and the closed-loop detection of the sampled signal will continue until the current detection rate is detected. The detection rate is within the set range of the expected detection rate; finally, the latest modified initial detection threshold is used as the target detection threshold.
  • the target detection threshold can be used to perform closed-loop detection of the sampled signal in the next set time period, so that the expected detection rate can be obtained. It can be seen that the adaptive detection method can improve the detection rate of signal detection, so that the disease can be accurately detected and the disease can be intervened in time.
  • FIG. 1 is a schematic diagram of steps of an adaptive closed-loop detection method for an implantable electrical stimulation device provided by an embodiment of the present specification.
  • FIG. 2 is a schematic diagram of steps of another adaptive closed-loop detection method for an implantable electrical stimulation device provided by an embodiment of the present specification.
  • FIG. 3 is a schematic diagram of steps of yet another adaptive closed-loop detection method for an implantable electrical stimulation device provided by an embodiment of the present specification.
  • FIG. 4 is a schematic diagram of steps of yet another adaptive closed-loop detection method for an implantable electrical stimulation device provided by an embodiment of the present specification.
  • FIG. 5 is a schematic diagram of steps of yet another adaptive closed-loop detection method for an implantable electrical stimulation device provided by an embodiment of the present specification.
  • FIG. 6 is a schematic structural diagram of an implantable electrical stimulation device provided by an embodiment of the present specification.
  • the self-adaptive closed-loop detection method for an implantable electrical stimulation device provided by the present application can improve the detection rate of signal detection, accurately detect diseases, and intervene in a timely manner.
  • the following will describe in detail the adaptive closed-loop detection method for an implantable electrical stimulation device and its various steps provided by the present application.
  • the implantable electrical stimulation device mentioned in this application can be implanted in the human body, and the electrode is in contact with the brain tissue to collect the EEG signal of the human brain tissue, and adjust the information after analyzing and judging the information displayed by the sampling signal.
  • the stimulation circuit sends out electrical impulses to intervene in the EEG signals of the brain tissue.
  • an adaptive closed-loop detection method for an implantable electrical stimulation device provided by the embodiment of the present specification is suitable for implantable electrical stimulation devices and systems in clinical medicine, and can be used for patients with epilepsy and the like.
  • the closed-loop detection of the sampling signal is carried out.
  • the occurrence of the disease can be detected in time or in advance according to the judgment of the sampling signal, so that the treatment can be intervened as soon as possible to avoid the occurrence of epilepsy and other events.
  • the closed-loop detection mentioned here is to complete the detection process by itself and adaptively modify the initial detection threshold without human interference.
  • the self-adaptive closed-loop detection method for an implantable electrical stimulation device can improve the detection rate of signal detection and accurately detect diseases in the real-time detection process.
  • the adaptive closed-loop detection method for an implantable electrical stimulation device provided by the embodiments of this specification includes:
  • Step 10 Set the expected detection rate and initial detection threshold
  • the expected detection rate is the expected detection rate expected to be obtained in the current set time period in which the closed-loop detection of the sampled signal is performed next.
  • the expected detection rate can be set according to the actual condition of the patient's condition. For example, the current set time period is one week, and the doctor can set the expected detection rate of epilepsy detection within the current set time period to be 80%.
  • the expected detection rate can be stored in a memory chip of a microcontroller unit in the implantable electrical stimulation device.
  • the implantable electrical stimulation device mentioned in this application mainly includes a sampling circuit, a micro-control unit and a stimulation circuit.
  • the sampling circuit is in contact with the brain tissue through electrode contacts, and the EEG signals at the implanted position are collected through the electrodes as sampling signals, and the The sampled signal is transmitted to the microcontroller unit.
  • the micro-control unit coordinates the mutual cooperation of various components in the implantable electrical stimulation device, and adjusts the electrical pulse signal sent by the stimulation circuit according to the processing result after processing the sampled signal.
  • the stimulation circuit is in contact with the brain tissue through the electrode contacts, and after receiving the adjustment instructions and electrical stimulation instructions from the micro-control unit, it sends electrical pulses to the location where the electrodes are implanted.
  • the adaptive closed-loop detection method provided by the embodiments of the present specification can be applied to timely or early detection of the occurrence of diseases according to the judgment of the sampling signal in the detection process, which can improve the detection rate of signal detection and accurately detect the diseases.
  • the initial detection threshold may be the correspondence between the expected detection rate and the initial detection threshold obtained by the doctor according to the empirical data, or may be the initial detection threshold directly set by the empirical data.
  • the initial detection threshold is an empirical value. Due to the individual differences of different patients, the initial detection threshold is not suitable enough to accurately detect the disease based on the collected sampling signals. The initial detection threshold needs to be further optimized to meet different requirements. The individual differences of patients can improve the detection rate.
  • half of the initial detection threshold may be taken as the initial detection threshold to detect the sampled signal.
  • Step 20 perform closed-loop detection of the sampling signal within the current set time period based on the initial detection threshold to obtain the current detection rate;
  • the closed-loop detection of the sampling signal is performed within the current set time period based on the initial detection threshold until the current set time period ends, and the current detection rate is obtained by statistics.
  • Step 30 Compare the current detection rate with the expected detection rate
  • the current detection rate obtained based on the initial detection threshold in the currently set time period is compared with the expected detection rate to determine whether the current detection rate reaches the expected detection rate.
  • the comparison here can be a simple comparison of the size, or it can be a comparison between the current detection rate and the set range of the expected detection rate, to determine whether the current detection rate falls within the set range of the expected detection rate.
  • Step 40 if the current detection rate is not within the set range of the expected detection rate, adaptively modify the initial detection threshold and continue to perform closed-loop detection of the sampled signal until the current detection rate is within the set range of the expected detection rate;
  • the current detection rate is not within the set range of the expected detection rate, after adaptively modifying the initially set initial detection threshold, continue to use the modified initial detection threshold to continue the closed-loop detection of the sampled signal. After setting the current detection rate within the time period, compare it with the expected detection rate, and stop modifying the initial detection threshold until the current detection rate is within the set range of the expected detection rate.
  • Step 50 Use the newly modified initial detection threshold as the target detection threshold.
  • the latest modified initial detection threshold is used as the target detection threshold to perform closed-loop detection of the sampled signal next.
  • step 40 if the current detection rate is not within the set range of the expected detection rate, adaptively modify the initial detection rate When the threshold is exceeded, the closed-loop detection of the sampled signal continues, including:
  • Step 400 if the current detection rate is less than the lower limit of the set range of the expected detection rate, remove half of the initial detection threshold;
  • the setting range of the expected detection rate can be set according to actual clinical experience, and as long as it is within the setting range of the expected detection rate, it can be considered that the current detection rate generally meets the expected detection rate. If the current detection rate is less than the lower limit of the set range of the expected detection rate, it indicates that the initial detection threshold is high, and the abnormal sampling signal closed-loop detection of the impending disease cannot be detected in time during the closed-loop detection of the sampling signal. . In this case, the initial detection threshold can be removed by half, and then the closed-loop detection of the sampled signal is performed according to the half of the initial detection threshold.
  • Step 410 Perform closed-loop detection of the sampled signal based on the modified initial detection threshold.
  • the closed-loop detection of the sampled signal is performed in the next set time period according to one-half of the initial detection threshold. Closed-loop detection of sampled signals. If there is a situation where the sampled signal is greater than the half of the initial detection threshold, the number of detections is increased by one.
  • each set time period corresponds to a detection rate and an initial detection threshold.
  • step 40 if the current detection rate is not within the set range of the expected detection rate, adaptively modify the initial detection rate After the threshold is exceeded, the EEG signal detection continues, including:
  • Step 420 if the current detection rate is greater than the upper limit of the set range of the expected detection rate, double the initial detection threshold;
  • the setting range of the expected detection rate can be set according to actual clinical experience, and as long as it is within the setting range of the expected detection rate, it can be considered that the current detection rate generally meets the expected detection rate. If the current detection rate is greater than the upper limit of the set range of the expected detection rate, it indicates that the initial detection threshold is low, and a slight abnormality in the sampling signal is also detected during the closed-loop detection of the sampling signal, resulting in Condition such as epilepsy that has occurred or is about to occur cannot be accurately distinguished. In this case, the initial detection threshold can be doubled, and then closed-loop detection of the sampled signal is performed according to twice the initial detection threshold.
  • Step 430 Perform closed-loop detection of the sampled signal based on the modified initial detection threshold.
  • the closed-loop detection of the sampled signal is performed according to twice the initial detection threshold, where the detection threshold is the modified initial detection threshold, that is, the closed-loop detection of the sampled signal is performed according to twice the previous initial detection threshold. If there is a situation where the sampled signal is greater than twice the initial detection threshold, the number of detections is increased by one.
  • step 30 after comparing the current detection rate with the expected detection rate, the adaptive closed-loop detection method provided by the embodiments of this specification further includes:
  • Step 70 If the current detection rate is within the set range of the expected detection rate, the initial detection threshold is used as the target detection threshold corresponding to the expected detection rate.
  • the target detection threshold can be used to perform closed-loop detection of the sampled signal in the next set time period.
  • the doctor sets the expected detection rate N that epilepsy is expected to be detected within the current set time period, and stores it in the storage unit of the microcontroller unit MCU;
  • T1 the initial detection threshold of epilepsy and record it as T1 (1/2T1 in case of uncertainty), and record the current detection rate obtained by using T1 to collect EEG signals in the current set time period closed-loop. is N1;
  • the current detection rate corresponding to the next set time period obtained after the closed-loop acquisition of EEG signals in the next set time period is recorded as N2;
  • the present application provides an adaptive closed-loop detection method for an implantable electrical stimulation device, in which an expected detection rate and an initial detection threshold are set; based on the initial detection threshold, within a currently set time period The sampling signal closed-loop detection is performed, and the current detection rate is obtained after the current set time period ends. Next, compare the current detection rate with the expected detection rate; if the current detection rate is not within the set range of the expected detection rate, the initial detection threshold will be adaptively modified and the closed-loop detection of the sampled signal will continue until the current detection rate is detected. The detection rate is within the set range of the expected detection rate; finally, the latest modified initial detection threshold is used as the target detection threshold.
  • the target detection threshold can be used to perform closed-loop detection of the sampled signal in the next set time period, so that the expected detection rate can be obtained. It can be seen that the adaptive detection method can improve the detection rate of signal detection, so that the disease can be accurately detected and the disease can be intervened in time.
  • an implantable electrical stimulation device 1 is provided in the embodiment of this specification.
  • the implantable electrical stimulation device is suitable for implantable electrical stimulation systems in clinical medicine, and can sample signals for patients with epilepsy and the like. In the detection process, according to the judgment of the sampling signal, the appearance of the disease can be detected in time or in advance, so that the treatment can be intervened as soon as possible to avoid the occurrence of epilepsy and other events.
  • the detection parameter optimization method for an implantable electrical stimulation device can improve the detection rate of signal detection in the real-time detection process, and accurately detect diseases.
  • the implantable electrical stimulation device includes:
  • the setting module 10 is used to set the expected detection rate and the initial detection threshold
  • the expected detection rate is the expected detection rate expected to be obtained in the current set time period in which the closed-loop detection of the sampled signal is performed next.
  • the expected detection rate can be set according to the actual condition of the patient's condition. For example, the current set time period is one week, and the doctor can set the expected detection rate of epilepsy detection within the current set time period to be 80%.
  • the expected detection rate can be stored in a memory chip of a microcontroller unit in the implantable electrical stimulation device.
  • the implantable electrical stimulation device mentioned in this application mainly includes a sampling circuit, a micro-control unit and a stimulation circuit.
  • the sampling circuit is in contact with the brain tissue through electrode contacts, and the EEG signals at the implanted position are collected through the electrodes as sampling signals, and the The sampled signal is transmitted to the microcontroller unit.
  • the micro-control unit coordinates the mutual cooperation of various components in the implantable electrical stimulation device, and adjusts the electrical pulse signal sent by the stimulation circuit according to the processing result after processing the sampled signal.
  • the stimulation circuit is in contact with the brain tissue through the electrode contacts, and after receiving the adjustment instructions and electrical stimulation instructions from the micro-control unit, it sends electrical pulses to the location where the electrodes are implanted.
  • the self-adaptive closed-loop detection device provided by the embodiments of the present specification can be suitable for detecting the occurrence of diseases in time or in advance according to the judgment of sampling signals in the detection process, which can improve the detection rate of signal detection and accurately detect diseases.
  • the initial detection threshold may be a correspondence table between the expected detection rate and the initial detection threshold obtained by the doctor according to empirical data, or may be an initial detection threshold set by empirical data.
  • the initial detection threshold is an empirical value. Due to the individual differences of different patients, the initial detection threshold is not suitable enough to accurately detect the disease based on the collected sampling signals. The initial detection threshold needs to be further optimized to meet different requirements. The individual differences of patients can improve the detection rate.
  • half of the initial detection threshold may be taken as the initial detection threshold to detect the sampled signal.
  • the detection module 20 is configured to perform closed-loop detection of the sampling signal within the currently set time period based on the initial detection threshold to obtain the current detection rate;
  • the closed-loop detection of the sampling signal is performed within the current set time period based on the initial detection threshold.
  • the current detection times are increased by one time until the current At the end of the set time period, the current detection rate is obtained by statistics.
  • a comparison module 30 for comparing the current detection rate with the expected detection rate
  • the current detection rate obtained based on the initial detection threshold in the currently set time period is compared with the expected detection rate to determine whether the current detection rate reaches the expected detection rate.
  • the comparison here can be a simple comparison of the secondary size, or it can be a comparison between the current detection rate and the set range of the expected detection rate to determine whether the current detection rate falls within the set range of the expected detection rate.
  • the detection module 20 is further configured to modify the initial detection threshold and continue to perform closed-loop detection of the sampling signal until the current detection rate is within the set range of the expected detection rate if the current detection rate is not within the set range of the expected detection rate Inside;
  • the current detection rate is not within the set range of the expected detection rate, after adaptively modifying the initially set initial detection threshold, continue to use the modified initial detection threshold to continue the closed-loop detection of the sampled signal. After setting the current detection rate within the time period, compare it with the expected detection rate, and stop modifying the initial detection threshold until the current detection rate is within the set range of the expected detection rate.
  • the setting module 10 is further configured to use the newly modified initial detection threshold as the target detection threshold.
  • the latest modified initial detection threshold is used as the target detection threshold to perform closed-loop detection of the sampling signal in the next set time period.
  • the detection module 20 is specifically used for:
  • the initial detection threshold will be removed by half
  • the setting range of the expected detection rate can be set according to actual clinical experience, and as long as it is within the setting range of the expected detection rate, it can be considered that the current detection rate generally meets the expected detection rate. If the current detection rate is less than the lower limit of the set range of the expected detection rate, it indicates that the initial detection threshold is high, and the abnormal sampling signal closed-loop detection of the impending disease cannot be detected in advance in the closed-loop detection of the sampling signal. . In this case, the initial detection threshold can be removed by half, and then the closed-loop detection of the sampled signal is performed according to the half of the initial detection threshold.
  • the closed-loop detection of the sampled signal is performed based on the modified initial detection threshold.
  • the closed-loop detection of the sampled signal is performed in the next set time period according to one-half of the initial detection threshold. Closed-loop detection of sampled signals. If there is a situation where the sampled signal is greater than the half of the initial detection threshold, the number of detections is increased by one.
  • each set time period corresponds to a detection rate and an initial detection threshold.
  • the detection module 20 is also specifically used for:
  • the setting range of the expected detection rate can be set according to actual clinical experience, and as long as it is within the setting range of the expected detection rate, it can be considered that the current detection rate generally meets the expected detection rate. If the current detection rate is greater than the upper limit of the set range of the expected detection rate, it indicates that the initial detection threshold is low, and a slight abnormality in the sampling signal is also detected during the closed-loop detection of the sampling signal, resulting in Condition such as epilepsy that has occurred or is about to occur cannot be accurately distinguished. In this case, the initial detection threshold can be doubled, and then closed-loop detection of the sampled signal is performed according to twice the initial detection threshold.
  • the closed-loop detection of the sampled signal is performed based on the modified initial detection threshold.
  • the detection threshold is the modified initial detection threshold, that is, the closed-loop detection of the sampled signal is performed according to twice the previous initial detection threshold . If there is a situation where the sampled signal is greater than twice the initial detection threshold, the number of detections is increased by one.
  • the setting module 10, after the comparison module 30 compares the current detection rate with the expected detection rate is further used for:
  • the initial detection threshold is used as the target detection threshold.
  • the target detection threshold can be used to perform closed-loop detection of the sampled signal in the next set time period.
  • an implantable electrical stimulation device provided by the present application, after setting the expected detection rate and the initial detection threshold; after determining the expected detection rate and the initial detection threshold, based on the initial detection threshold at the current
  • the sampling signal closed-loop detection is performed within the set time period, and the current detection rate is obtained after the current set time period ends.
  • compare the current detection rate with the expected detection rate if the current detection rate is not within the set range of the expected detection rate, the initial detection threshold will be adaptively modified and the closed-loop detection of the sampled signal will continue until the current detection rate is detected.
  • the detection rate is within the set range of the expected detection rate; finally, the latest modified initial detection threshold is used as the target detection threshold.
  • the target detection threshold can be used to perform closed-loop detection of the sampled signal in the next set time period, so that the expected detection rate can be obtained. It can be seen that the adaptive detection method can improve the detection rate of signal detection, so that the disease can be accurately detected and the disease can be intervened in time.
  • An implantable electrical stimulation system provided by an embodiment of the present specification includes an external device and an implantable electrical stimulation device as shown in FIG. 6 , and the external device is connected in communication with the implantable electrical stimulation device.
  • the implantable electrical stimulation device includes:
  • the setting module 10 is used to set the expected detection rate and the initial detection threshold
  • the expected detection rate is the expected detection rate expected to be obtained in the current set time period in which the closed-loop detection of the sampled signal is performed next.
  • the expected detection rate can be set according to the actual condition of the patient's condition. For example, the current set time period is one week, and the doctor can set the expected detection rate of epilepsy detection within the current set time period to be 80%.
  • the expected detection rate can be stored in a memory chip of a microcontroller unit in the implantable electrical stimulation device.
  • the implantable electrical stimulation device mentioned in this application mainly includes a sampling circuit, a micro-control unit and a stimulation circuit.
  • the sampling circuit is in contact with the brain tissue through electrode contacts, and the EEG signals at the implanted position are collected through the electrodes as sampling signals, and the The sampled signal is transmitted to the microcontroller unit.
  • the micro-control unit coordinates the mutual cooperation of various components in the implantable electrical stimulation device, and adjusts the electrical pulse signal sent by the stimulation circuit according to the processing result after processing the sampled signal.
  • the stimulation circuit is in contact with the brain tissue through the electrode contacts, and after receiving the adjustment instructions and electrical stimulation instructions from the micro-control unit, it sends electrical pulses to the location where the electrodes are implanted.
  • the self-adaptive closed-loop detection device provided by the embodiments of the present specification can be suitable for detecting the occurrence of diseases in time or in advance according to the judgment of sampling signals in the detection process, which can improve the detection rate of signal detection and accurately detect diseases.
  • the initial detection threshold can be obtained from the correspondence table between the expected detection rate and the initial detection threshold obtained by the doctor according to the empirical data, or the initial detection threshold can be set according to the empirical data.
  • the initial detection threshold is an empirical value. Due to the individual differences of different patients, the initial detection threshold is not suitable enough to accurately detect the disease based on the collected sampling signals. The initial detection threshold needs to be further optimized to meet different requirements. The individual differences of patients can improve the detection rate.
  • half of the initial detection threshold may be taken as the initial detection threshold to detect the sampled signal.
  • the detection module 20 is configured to perform closed-loop detection of the sampling signal within the currently set time period based on the initial detection threshold to obtain the current detection rate;
  • the closed-loop detection of the sampling signal is performed within the current set time period based on the initial detection threshold.
  • the current detection rate is increased once until the current At the end of the set time period, the current detection rate is obtained by statistics.
  • a comparison module 30 for comparing the current detection rate with the expected detection rate
  • the current detection rate obtained based on the initial detection threshold in the currently set time period is compared with the expected detection rate to determine whether the current detection rate reaches the expected detection rate.
  • the comparison here can be a simple comparison of the size, or it can be a comparison between the current detection rate and the set range of the expected detection rate, to determine whether the current detection rate falls within the set range of the expected detection rate.
  • the detection module 20 is further configured to adaptively modify the initial detection threshold and continue to perform closed-loop detection of the sampled signal until the current detection rate is within the set range of the expected detection rate if the current detection rate is not within the set range of the expected detection rate. within a certain range;
  • the current detection rate is not within the set range of the expected detection rate, after modifying the initially set initial detection threshold, continue to use the modified initial detection threshold to continue the closed-loop detection of the sampling signal, and after obtaining the new current setting After comparing the current detection rate within the time period with the expected detection rate, stop modifying the initial detection threshold until the current detection rate is within the set range of the expected detection rate.
  • the setting module 10 is further configured to use the newly modified initial detection threshold as the target detection threshold.
  • the latest modified initial detection threshold is used as the target detection threshold to perform closed-loop detection of the sampling signal in the next set time period.
  • an implantable electrical stimulation system performs closed-loop detection of the sampling signal within the currently set time period based on the initial detection threshold after setting the expected detection rate and the initial detection threshold.
  • the current detection rate is obtained after the end of the fixed time period.
  • compare the current detection rate with the expected detection rate if the current detection rate is not within the set range of the expected detection rate, the initial detection threshold will be adaptively modified and the closed-loop detection of the sampled signal will continue until the current detection rate is detected.
  • the detection rate is within the set range of the expected detection rate; finally, the latest modified initial detection threshold is used as the target detection threshold.
  • the target detection threshold After the target detection threshold is obtained, the target detection threshold can be used to perform closed-loop detection of the sampled signal in the next set time period, so that the expected detection rate can be obtained. It can be seen that the adaptive detection method can improve the detection rate of signal detection, so that the disease can be accurately detected and the disease can be intervened in time.
  • a storage medium provided by an embodiment of the present specification is used for computer-readable storage, where the storage medium stores one or more programs, and when the one or more programs can be executed by one or more processors, implements the following:
  • the steps of the adaptive closed-loop detection method shown in FIG. 1 to FIG. 5 specifically include:
  • Step 10 Set the expected detection rate and initial detection threshold
  • the expected detection rate is the expected detection rate expected to be obtained in the current set time period in which the closed-loop detection of the sampled signal is performed next.
  • the expected detection rate can be set according to the actual condition of the patient's condition. For example, the current set time period is one week, and the doctor can set the expected detection rate of epilepsy detection within the current set time period to be 80%.
  • the expected detection rate can be stored in a memory chip of a microcontroller unit in the implantable electrical stimulation device.
  • the implantable electrical stimulation device mentioned in this application mainly includes a sampling circuit, a micro-control unit and a stimulation circuit.
  • the sampling circuit is in contact with the brain tissue through electrode contacts, and the EEG signals at the implanted position are collected through the electrodes as sampling signals, and the The sampled signal is transmitted to the microcontroller unit.
  • the micro-control unit coordinates the mutual cooperation of various components in the implantable electrical stimulation device, and adjusts the electrical pulse signal sent by the stimulation circuit according to the processing result after processing the sampled signal.
  • the stimulation circuit is in contact with the brain tissue through the electrode contacts, and after receiving the adjustment instructions and electrical stimulation instructions from the micro-control unit, it sends electrical pulses to the location where the electrodes are implanted.
  • the adaptive closed-loop detection method provided by the embodiments of the present specification can be applied to timely or early detection of the occurrence of diseases according to the judgment of the sampling signal in the detection process, which can improve the detection rate of signal detection and accurately detect the diseases.
  • the initial detection threshold may be obtained from the correspondence table between the expected detection rate and the initial detection threshold obtained by the doctor according to the empirical data, or may be directly set according to the empirical data.
  • the initial detection threshold is an empirical value. Due to the individual differences of different patients, the initial detection threshold is not suitable enough to accurately detect the disease based on the collected sampling signals. The initial detection threshold needs to be further optimized to meet different requirements. The individual differences of patients can improve the detection rate.
  • half of the initial detection threshold may be taken as the initial detection threshold to detect the sampled signal.
  • Step 20 perform closed-loop detection of the sampling signal within the current set time period based on the initial detection threshold to obtain the current detection rate;
  • the closed-loop detection of the sampling signal is performed within the current set time period based on the initial detection threshold.
  • the current detection times are increased by one time until the current At the end of the set time period, the current detection rate is obtained by statistics.
  • Step 30 Compare the current detection rate with the expected detection rate
  • the current detection rate obtained based on the initial detection threshold in the currently set time period is compared with the expected detection rate to determine whether the current detection rate reaches the expected detection rate.
  • the comparison here can be a simple comparison of the size, or it can be a comparison between the current detection rate and the set range of the expected detection rate, to determine whether the current detection rate falls within the set range of the expected detection rate.
  • Step 40 if the current detection rate is not within the set range of the expected detection rate, adaptively modify the initial detection threshold and continue to perform closed-loop detection of the sampled signal until the current detection rate is within the set range of the expected detection rate;
  • the current detection rate is not within the set range of the expected detection rate, after modifying the initially set initial detection threshold, continue to use the modified initial detection threshold to continue the closed-loop detection of the sampling signal, and after obtaining the new current setting After comparing the current detection rate within the time period with the expected detection rate, stop modifying the initial detection threshold until the current detection rate is within the set range of the expected detection rate.
  • Step 50 Use the newly modified initial detection threshold as the target detection threshold corresponding to the expected detection rate.
  • the latest modified initial detection threshold is used as the target detection threshold to perform closed-loop detection of the sampling signal in the next set time period.
  • the present application provides an adaptive closed-loop detection method for an implantable electrical stimulation device. After first setting the expected detection rate and the initial detection threshold, the current set time period based on the initial detection threshold is set. The sampling signal closed-loop detection is carried out within the current set time period, and the current detection rate is obtained after the current set time period ends. Next, compare the current detection rate with the expected detection rate; if the current detection rate is not within the set range of the expected detection rate, the initial detection threshold will be adaptively modified and the closed-loop detection of the sampled signal will continue until the current detection rate is detected. The detection rate is within the set range of the expected detection rate; finally, the latest modified initial detection threshold is used as the target detection threshold.
  • the target detection threshold After the target detection threshold is obtained, the target detection threshold can be used to perform closed-loop detection of the sampled signal in the next set time period, so that the expected detection rate can be obtained. It can be seen that the adaptive detection method can improve the detection rate of signal detection, so that the disease can be accurately detected and the disease can be intervened in time.
  • a typical implementation device is a computer.
  • the computer can be, for example, a personal computer, a laptop computer, a cellular phone, a camera phone, a smart phone, a personal digital assistant, a media player, a navigation device, an email device, a game console, a tablet computer, a wearable device, or A combination of any of these devices.
  • Computer-readable storage media includes both persistent and non-permanent, removable and non-removable media, and storage of information can be implemented by any method or technology.
  • Information may be computer readable instructions, data structures, modules of programs, or other data.
  • Examples of computer storage media include, but are not limited to, phase-change memory (PRAM), static random access memory (SRAM), dynamic random access memory (DRAM), other types of random access memory (RAM), read only memory (ROM), Electrically Erasable Programmable Read Only Memory (EEPROM), Flash Memory or other memory technology, Compact Disc Read Only Memory (CD-ROM), Digital Versatile Disc (DVD) or other optical storage, Magnetic tape cassettes, magnetic tape magnetic disk storage or other magnetic storage devices or any other non-transmission medium that can be used to store information that can be accessed by a computing device.
  • computer-readable media does not include transitory computer-readable media, such as modulated data signals and carrier waves.

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Abstract

本说明书一个或多个实施例公开了一种用于植入式电刺激装置的自适应闭环检测方法及系统。该用于植入式电刺激装置的自适应闭环检测方法,包括:设置期望检出率和初始检出阈值;基于所述初始检出阈值在当前设定时间段内进行采样信号闭环检测,得到当前检出率;将所述当前检出率与所述期望检出率进行比较;如果所述当前检出率不在所述期望检出率的设定范围内,则自适应修改所述初始检出阈值继续进行采样信号闭环检测,直至所述当前检出率在所述期望检出率的所述设定范围内;将最新修改后的所述初始检出阈值作为目标检出阈值,可以提高信号检测的检出率,准确检测出病症,从而及时对病症进行干预。

Description

用于植入式电刺激装置的自适应闭环检测方法及系统 技术领域
本文件涉及医疗设备技术领域,尤其涉及一种用于植入式电刺激装置的自适应闭环检测方法及系统。
背景技术
目前,植入式医疗系统已经广泛应用于医学临床上,包括植入式电刺激系统、植入式药物注射系统等。其中植入式电刺激系统包括植入式神经电刺激系统和植入式心脏电刺激系统,植入式神经电刺激系统主要包括植入体内的植入式电脉冲发生器、刺激电极以及体外的控制器。植入式电脉冲发生器所产生的电刺激脉冲传输到刺激电极,由刺激电极传输至特定神经靶点进行电刺激,从而可以治疗如帕金森、癫痫等病症。
通常,植入式电脉冲发生器在对神经靶点进行电刺激用来治疗病症之前,通过采集电路采集生理信号以便根据采样信号判断患者是否已经或者即将发病。如果已经或者即将发病,则调整植入式电脉冲发生器向刺激电极发送电刺激脉冲,从而进行干预或者提前干预,防止帕金森、癫痫等病症的发生。但是目前的植入式电刺激装置对帕金森、癫痫等病症的检出率较低,造成不能对病症准确及时的干预。如何提高信号检测的检出率,准确检测出病症,从而及时对病症进行干预,成为亟需解决的技术问题。
发明内容
本说明书一个或多个实施例的目的是提供一种用于植入式电刺激装置的自适应闭环检测方法及系统,可以提高信号检测的检出率,准确检测出病症,从而及时对病症进行干预。
为解决上述技术问题,本说明书一个或多个实施例是这样实现的:
第一方面,提出了一种用于植入式电刺激装置的自适应闭环检测方法,包括:设置期望检出率和初始检出阈值;基于所述初始检出阈值在当前设定时间段内进行采样信号闭环检测,得到当前检出率;将所述当前检出率与所述期望检出率进行比较;如果所述当前检出率不在所述期望检出率的设定范围内,则自适应修改所述初始检出阈值继续进行采样信号闭环检测,直至所述当前检出率在所述期望检出率的所述设定范围内;将最新修改后的所述初始检出阈值作为目标检出阈值。
第二方面,提出了一种植入式电刺激装置,包括:设置模块,用于设置期望检出率和初始检出阈值;检测模块,用于基于所述初始检出阈值在当前设定时间段内进行采样信号 闭环检测,得到当前检出率;比较模块,用于将所述当前检出率与所述期望检出率进行比较;以及,所述检测模块,还用于如果所述当前检出率不在所述期望检出率的设定范围内,则自适应修改所述初始检出阈值继续进行采样信号闭环检测,直至所述当前检出率在所述期望检出率的所述设定范围内;所述阈值获取模块,还用于将最新修改后的所述初始检出阈值作为目标检出阈值。
第三方面,提出了一种植入式电刺激系统,所述系统包括外部设备和如上文所述的植入式电刺激装置,所述外部设备与所述植入式电刺激装置通信连接。
第四方面,提出了一种存储介质,用于计算机可读存储,所述存储介质存储有一个或者多个程序,所述一个或者多个程序可被一个或者多个处理器执行时,实现如上文所述的自适应闭环检测方法的步骤。
由以上本说明书一个或多个实施例提供的技术方案可见,本申请提供的一种用于植入式电刺激装置的自适应闭环检测方法,在设置期望检出率和初始检出阈值后,基于初始检出阈值在当前设定时间段内进行采样信号闭环检测,该当前设定时间段结束后得到当前检出率。接下来将当前检出率与期望检出率进行比较;如果当前检出率不在期望检出率的设定范围内,则自适应修改初始检出阈值继续进行采样信号闭环检测,直至当前检出率在期望检出率的设定范围内;最后将最新修改后的初始检出阈值作为目标检出阈值。在得到期望检出率对应的目标检出阈值后,可以采用该目标检出阈值在接下来的设定时间段内进行采样信号闭环检测,以便可以获取期望检出率。可以看出,该自适应检测方式可以提高信号检测的检出率,从而能够准确检测出病症,对病症及时进行干预。
附图说明
为了更清楚地说明本说明书一个或多个实施例或现有技术中的技术方案,下面将对一个或多个实施例或现有技术描述中所需要使用的附图作简单地介绍,显而易见地,下面描述中的附图仅仅是本说明书中记载的一些实施例,对于本领域普通技术人员来讲,在不付出创造性劳动性的前提下,还可以根据这些附图获得其他的附图。
图1是本说明书实施例提供的一种用于植入式电刺激装置的自适应闭环检测方法的步骤示意图。
图2是本说明书实施例提供的另一种用于植入式电刺激装置的自适应闭环检测方法的步骤示意图。
图3是本说明书实施例提供的又一种用于植入式电刺激装置的自适应闭环检测方法的步骤示意图。
图4是本说明书实施例提供的又一种用于植入式电刺激装置的自适应闭环检测方法的步骤示意图。
图5是本说明书实施例提供的又一种用于植入式电刺激装置的自适应闭环检测方法的步骤示意图。
图6是本说明书实施例提供的一种植入式电刺激装置结构示意图。
具体实施方式
为了使本技术领域的人员更好地理解本说明书中的技术方案,下面将结合本说明书一个或多个实施例中的附图,对本说明书一个或多个实施例中的技术方案进行清楚、完整地描述,显然,所描述的一个或多个实施例仅仅是本说明书一部分实施例,而不是全部的实施例。基于本说明书中的一个或多个实施例,本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例,都应当属于本文件的保护范围。
本申请提供的用于植入式电刺激装置的自适应闭环检测方法可以提高信号检测的检出率,准确检测出病症,从而及时对病症进行干预。下面将详细地描述本申请提供的用于植入式电刺激装置的自适应闭环检测方法及其各个步骤。
本申请中提到的用于植入式电刺激装置可以为植入人体体内,通过电极与脑组织接触,采集人体脑组织的脑电信号,通过对采样信号所显示的信息进行分析判断后调整刺激电路发出电脉冲信号,从而对脑组织的脑电信号进行干预。
实施例一
参照图1所示,为本说明书实施例提供的一种用于植入式电刺激装置的自适应闭环检测方法,适用于临床医学上的植入式电刺激装置和系统,可以对癫痫等患者进行采样信号的闭环检测,在闭环检测过程中根据采样信号的判断及时或者提前发现病症的出现,从而可以及早干预治疗,避免癫痫等事件的发生。这里提到的闭环检测是自行完成检测过程并且自适应修改初始检出阈值,不需要人为干扰。该用于植入式电刺激装置的自适应闭环检测方法,在实时检测过程中可以提高信号检测的检出率,准确检测出病症。本说明书实施例提供的用于植入式电刺激装置的自适应闭环检测方法,包括:
步骤10:设置期望检出率和初始检出阈值;
首先设置期望检出率,该期望检出率是在接下来进行采样信号闭环检测的当前设定时间段内希望得到的期望检出率。期望检出率可以根据患者病症的实际情况进行设置,比如当前设定时间段是一周,医生可以设置当前设定时间段内检出癫痫的期望检出率可以为80%。可以将该期望检出率存储在植入式电刺激装置中微控制单元的存储芯片中。本申请提 到的植入式电刺激装置主要包括采样电路、微控制单元和刺激电路,采样电路通过电极触点与脑组织接触,通过电极采集植入位置的脑电信号作为采样信号,并将该采样信号传输至微控制单元。微控制单元协调植入式电刺激装置中各个部件的相互协作,并对采样信号进行处理后根据处理结果调节刺激电路发出的电脉冲信号。刺激电路通过电极触点与脑组织接触,在接收到微控制单元发出的调整指令和电刺激指令后,发送电脉冲至电极所植入的位置。
本说明书实施例提供的自适应闭环检测方法可以适用于在检测过程中根据采样信号的判断及时或者提前发现病症的出现,可以提高信号检测的检出率,准确检测出病症。
初始检出阈值可以是医生根据经验数据得到的期望检出率和初始检出阈值的对应关系,也可以是经验数据直接设置初始检出阈值。该初始检出阈值是经验值,由于不同患者的个体差异,该初始检出阈值不够合适,并不能够基于采集的采样信号能够准确检出病症,需要对该初始检出阈值进一步优化,满足不同患者的个体差异,提高检出率。
在不确定初始检出阈值是否合适的情况下,可以取初始检出阈值的一半作为初始检出阈值进行采样信号的检测。
步骤20:基于初始检出阈值在当前设定时间段内进行采样信号闭环检测,得到当前检出率;
在确定好初始检出阈值后,基于该初始检出阈值在当前设定时间段内进行采样信号闭环检测,直至当前设定时间段结束,统计得到当前检出率。
步骤30:将当前检出率与期望检出率进行比较;
然后将当前设定时间段内基于该初始检出阈值得到的当前检出率与期望检出率进行比较,确定当前检出率是否达到期望检出率。这里的比较可以是大小的简单比较,也可以是当前检出率与期望检出率的设定范围进行比较,判断当前检出率是否落入期望检出率的设定范围内。
步骤40:如果当前检出率不在期望检出率的设定范围内,则自适应修改初始检出阈值继续进行采样信号闭环检测,直至当前检出率在期望检出率的设定范围内;
如果当前检出率不在期望检出率的设定范围内,则自适应修改当初设置的初始检出阈值后,继续采用修改后的初始检出阈值继续进行采样信号闭环检测,在得到新的当前设定时间段内的当前检出率后,再与期望检出率进行比较,直至当前检出率在期望检出率的设定范围内后,停止修改初始检出阈值。
步骤50:将最新修改后的初始检出阈值作为目标检出阈值。
停止修改初始检出阈值后,将最新修改后的初始检出阈值作为目标检出阈值在接下来进行采样信号闭环检测。
参照图2所示,在一些实施例中,本说明书实施例提供的自适应闭环检测方法中,步骤40:如果当前检出率不在期望检出率的设定范围内,则自适应修改初始检出阈值继续进行采样信号闭环检测,具体包括:
步骤400:如果当前检出率小于期望检出率的设定范围的下限值时,将初始检出阈值除去一半;
期望检出率的设定范围可以根据实际临床经验进行设定,只要在该期望检出率的设定范围内的话,可以认为当前检出率大体满足期望检出率。如果当前检出率小于期望检出率的设定范围的下限值,则表明初始检出阈值较高,在对采样信号闭环检测时并不能够及时将即将出现病症的异常采样信号闭环检测出来。这种情况下可以将初始检出阈值除去一半,接下来按照二分之一的初始检出阈值进行采样信号闭环检测。
步骤410:基于修改后的初始检出阈值进行采样信号闭环检测。
按照二分之一的初始检出阈值在下一个设定时间段进行采样信号闭环检测,这里的检出阈值为修改后的初始检出阈值,即按照上一个初始检出阈值的二分之一进行采样信号闭环检测。如果出现采样信号大于该二分之一初始检出阈值的情况,则检出次数增加一次。
这里需要说明的是,每一个设定时间段对应一个检出率和初始检出阈值。
参照图3所示,在一些实施例中,本说明书实施例提供的自适应闭环检测方法中,步骤40:如果当前检出率不在期望检出率的设定范围内,则自适应修改初始检出阈值继续进行脑电信号检测,具体包括:
步骤420:如果当前检出率大于期望检出率的设定范围的上限值时,将初始检出阈值增大一倍;
期望检出率的设定范围可以根据实际临床经验进行设定,只要在该期望检出率的设定范围内的话,可以认为当前检出率大体满足期望检出率。如果当前检出率大于期望检出率的设定范围的上限值,则表明初始检出阈值较低,在对采样信号闭环检测时将采样信号发生稍微异常的情况也一并检测出来,导致不能准确分辨已经发生或者即将发生的癫痫等病症。这种情况下可以将初始检出阈值增大一倍,接下来按照两倍的初始检出阈值进行采样信号闭环检测。
步骤430:基于修改后的初始检出阈值进行采样信号闭环检测。
按照两倍的初始检出阈值接下来进行采样信号闭环检测,这里的检出阈值为修改后的 初始检出阈值,即按照上一个初始检出阈值的两倍进行采样信号闭环检测。如果出现采样信号大于该两倍的初始检出阈值的情况,则将检出次数增加一次。
参照图4所示,在一些实施例中,步骤30:将当前检出率与期望检出率进行比较之后,本说明书实施例提供的自适应闭环检测方法,还包括:
步骤70:如果当前检出率在期望检出率的设定范围内,则将初始检出阈值作为期望检出率对应的目标检出阈值。
在将当前检出率与期望检出率进行比较之后,如果当前检出率在期望检出率的设定范围内,则将初始检出阈值作为期望检出率对应的目标检出阈值。从而可以采用该目标检出阈值在接下来的设定时间段内进行采样信号闭环检测。
下面结合图5所示对本申请提供的用于植入式电刺激装置的自适应闭环检测方法的一个具体实施例进行详细描述:
1.医生设置期望在当前设定时间段内检出癫痫的期望检出率N,并存储在微控制单元MCU的存储单元中;
2.取癫痫病症的初始检出阈值记为T1(在不确定的情况下可以取1/2T1)范围的,使用T1在当前设定时间段闭环采集脑电信号后得到的当前检出率记为N1;
3.在比较器中比较N与N1的大小,若N1<0.9N,则设T2=1/2T1,若N1>1.1N,则T2=2T1;
4.以T2为初始检出阈值在下一个设定时间段闭环采集脑电信号后得到的对应下一个设定时间段的当前检出率记为N2;
5.进一步比较N与N2,若N2<0.9N,则设T3=1/2T2,若N2>1.1N,则T3=2T2;以T3为初始检出阈值在接下来的设定时间段闭环采集脑电信号后得到的对应接下来设定时间段的当前检出率记为N3;
6.继续比较N与N3,直至0.9N≤Nm≤1.1N,得到最新修改后的初始检出阈值Tm,即为目标检出阈值。
通过上述技术方案,本申请提供的一种用于植入式电刺激装置的自适应闭环检测方法,在设置期望检出率和初始检出阈值;基于初始检出阈值在当前设定时间段内进行采样信号闭环检测,该当前设定时间段结束后得到当前检出率。接下来将当前检出率与期望检出率进行比较;如果当前检出率不在期望检出率的设定范围内,则自适应修改初始检出阈值继续进行采样信号闭环检测,直至当前检出率在期望检出率的设定范围内;最后将最新修改后的初始检出阈值作为目标检出阈值。在得到期望检出率对应的目标检出阈值后,可以采用该目标检出阈值在接下来的设定时间段内进行采样信号闭环检测,以便可以获取期望检 出率。可以看出,该自适应检测方式可以提高信号检测的检出率,从而能够准确检测出病症,对病症及时进行干预。
实施例二
参照图6所示,为本说明书实施例提供的一种植入式电刺激装置1,该植入式电刺激装置适用于临床医学上的植入式电刺激系统,可以对癫痫等患者进行采样信号的检测,在检测过程中根据采样信号的判断及时或者提前发现病症的出现,从而可以及早干预治疗,避免癫痫等事件的发生。该用于植入式电刺激装置的检测参数优化方法,在实时检测过程中可以提高信号检测的检出率,准确检测出病症。该植入式电刺激装置,包括:
设置模块10,用于设置期望检出率和初始检出阈值;
首先设置期望检出率,该期望检出率是在接下来进行采样信号闭环检测的当前设定时间段内希望得到的期望检出率。期望检出率可以根据患者病症的实际情况进行设置,比如当前设定时间段是一周,医生可以设置当前设定时间段内检出癫痫的期望检出率可以为80%。可以将该期望检出率存储在植入式电刺激装置中微控制单元的存储芯片中。本申请提到的植入式电刺激装置主要包括采样电路、微控制单元和刺激电路,采样电路通过电极触点与脑组织接触,通过电极采集植入位置的脑电信号作为采样信号,并将该采样信号传输至微控制单元。微控制单元协调植入式电刺激装置中各个部件的相互协作,并对采样信号进行处理后根据处理结果调节刺激电路发出的电脉冲信号。刺激电路通过电极触点与脑组织接触,在接收到微控制单元发出的调整指令和电刺激指令后,发送电脉冲至电极所植入的位置。
本说明书实施例提供的自适应闭环检测装置可以适用于在检测过程中根据采样信号的判断及时或者提前发现病症的出现,可以提高信号检测的检出率,准确检测出病症。
初始检出阈值可以是医生根据经验数据得到的期望检出率和初始检出阈值的对应关系表,也可以是经验数据设置初始检出阈值。该初始检出阈值是经验值,由于不同患者的个体差异,该初始检出阈值不够合适,并不能够基于采集的采样信号能够准确检出病症,需要对该初始检出阈值进一步优化,满足不同患者的个体差异,提高检出率。
在不确定初始检出阈值是否合适的情况下,可以取初始检出阈值的一半作为初始检出阈值进行采样信号的检测。
检测模块20,用于基于初始检出阈值在当前设定时间段内进行采样信号闭环检测,得到当前检出率;
在确定好初始检出阈值后,基于该初始检出阈值在当前设定时间段内进行采样信号闭 环检测,当采样信号超出该初始检出阈值时,则将当前检出次数增加一次,直至当前设定时间段结束,统计得到当前检出率。
比较模块30,用于将当前检出率与期望检出率进行比较;以及,
然后将当前设定时间段内基于该初始检出阈值得到的当前检出率与期望检出率进行比较,确定当前检出率是否达到期望检出率。这里的比较可以是次大小的简单比较,也可以是当前检出率与期望检出率的设定范围进行比较,判断当前检出率是否落入期望检出率的设定范围内。
检测模块20,还用于如果当前检出率不在期望检出率的设定范围内,则修改初始检出阈值继续进行采样信号闭环检测,直至当前检出率在期望检出率的设定范围内;
如果当前检出率不在期望检出率的设定范围内,则自适应修改当初设置的初始检出阈值后,继续采用修改后的初始检出阈值继续进行采样信号闭环检测,在得到新的当前设定时间段内的当前检出率后,再与期望检出率进行比较,直至当前检出率在期望检出率的设定范围内后,停止修改初始检出阈值。
设置模块10,还用于将最新修改后的初始检出阈值作为目标检出阈值。
停止修改初始检出阈值后,将最新修改后的初始检出阈值作为目标检出阈值在接下来来的设定时间段内进行采样信号闭环检测。
在一些实施例中,本说明书实施例提供的植入式电刺激装置中,检测模块20,具体用于:
如果当前检出率小于期望检出率的设定范围的下限值时,将初始检出阈值除去一半;
期望检出率的设定范围可以根据实际临床经验进行设定,只要在该期望检出率的设定范围内的话,可以认为当前检出率大体满足期望检出率。如果当前检出率小于期望检出率的设定范围的下限值,则表明初始检出阈值较高,在对采样信号闭环检测时并不能够提前将即将出现病症的异常采样信号闭环检测出来。这种情况下可以将初始检出阈值除去一半,接下来按照二分之一的初始检出阈值进行采样信号闭环检测。
基于修改后的初始检出阈值进行采样信号闭环检测。
按照二分之一的初始检出阈值在下一个设定时间段进行采样信号闭环检测,这里的检出阈值为修改后的初始检出阈值,即按照上一个初始检出阈值的二分之一进行采样信号闭环检测。如果出现采样信号大于该二分之一初始检出阈值的情况,则将检出次数增加一次。
这里需要说明的是,每一个设定时间段对应一个检出率和初始检出阈值。
在一些实施例中,本说明书实施例提供的植入式电刺激装置中,检测模块20,还具体 用于:
如果当前检出率大于期望检出率的设定范围的上限值时,将初始检出阈值增大一倍;
期望检出率的设定范围可以根据实际临床经验进行设定,只要在该期望检出率的设定范围内的话,可以认为当前检出率大体满足期望检出率。如果当前检出率大于期望检出率的设定范围的上限值,则表明初始检出阈值较低,在对采样信号闭环检测时将采样信号发生稍微异常的情况也一并检测出来,导致不能准确分辨已经发生或者即将发生的癫痫等病症。这种情况下可以将初始检出阈值增大一倍,接下来按照两倍的初始检出阈值进行采样信号闭环检测。
基于修改后的初始检出阈值进行采样信号闭环检测。
按照两倍的初始检出阈值在下一个设定时间段进行采样信号闭环检测,这里的检出阈值为修改后的初始检出阈值,即按照上一个初始检出阈值的两倍进行采样信号闭环检测。如果出现采样信号大于该两倍的初始检出阈值的情况,则将检出次数增加一次。
在一些实施例中,本说明书实施例提供的植入式电刺激装置中,设置模块10,在比较模块30将当前检出率与期望检出率进行比较之后,还用于:
如果当前检出率在期望检出率的设定范围内,则将初始检出阈值作为目标检出阈值。
在将当前检出率与期望检出率进行比较之后,如果当前检出率在期望检出率的设定范围内,则将初始检出阈值作为目标检出阈值。从而可以采用该目标检出阈值在接下来的设定时间段内进行采样信号闭环检测。
通过上述技术方案,本申请提供的一种植入式电刺激装置,在设置期望检出率和初始检出阈值;在确定好期望检出率和初始检出阈值后,基于初始检出阈值在当前设定时间段内进行采样信号闭环检测,该当前设定时间段结束后得到当前检出率。接下来将当前检出率与期望检出率进行比较;如果当前检出率不在期望检出率的设定范围内,则自适应修改初始检出阈值继续进行采样信号闭环检测,直至当前检出率在期望检出率的设定范围内;最后将最新修改后的初始检出阈值作为目标检出阈值。在得到期望检出率对应的目标检出阈值后,可以采用该目标检出阈值在接下来的设定时间段内进行采样信号闭环检测,以便可以获取期望检出率。可以看出,该自适应检测方式可以提高信号检测的检出率,从而能够准确检测出病症,对病症及时进行干预。
实施例三
本说明书实施例提供的一种植入式电刺激系统,包括外部设备和如图6所示的植入式电刺激装置,所述外部设备与所述植入式电刺激装置通信连接。所述植入式电刺激装置包 括:
设置模块10,用于设置期望检出率和初始检出阈值;
首先设置期望检出率,该期望检出率是在接下来进行采样信号闭环检测的当前设定时间段内希望得到的期望检出率。期望检出率可以根据患者病症的实际情况进行设置,比如当前设定时间段是一周,医生可以设置当前设定时间段内检出癫痫的期望检出率可以为80%。可以将该期望检出率存储在植入式电刺激装置中微控制单元的存储芯片中。本申请提到的植入式电刺激装置主要包括采样电路、微控制单元和刺激电路,采样电路通过电极触点与脑组织接触,通过电极采集植入位置的脑电信号作为采样信号,并将该采样信号传输至微控制单元。微控制单元协调植入式电刺激装置中各个部件的相互协作,并对采样信号进行处理后根据处理结果调节刺激电路发出的电脉冲信号。刺激电路通过电极触点与脑组织接触,在接收到微控制单元发出的调整指令和电刺激指令后,发送电脉冲至电极所植入的位置。
本说明书实施例提供的自适应闭环检测装置可以适用于在检测过程中根据采样信号的判断及时或者提前发现病症的出现,可以提高信号检测的检出率,准确检测出病症。
初始检出阈值可以是医生根据经验数据得到的期望检出率和初始检出阈值的对应关系表中获取,也可以是根据经验数据设置初始检出阈值。该初始检出阈值是经验值,由于不同患者的个体差异,该初始检出阈值不够合适,并不能够基于采集的采样信号能够准确检出病症,需要对该初始检出阈值进一步优化,满足不同患者的个体差异,提高检出率。
在不确定初始检出阈值是否合适的情况下,可以取初始检出阈值的一半作为初始检出阈值进行采样信号的检测。
检测模块20,用于基于初始检出阈值在当前设定时间段内进行采样信号闭环检测,得到当前检出率;
在确定好初始检出阈值后,基于该初始检出阈值在当前设定时间段内进行采样信号闭环检测,当采样信号超出该初始检出阈值时,则将当前检出率增加一次,直至当前设定时间段结束,统计得到当前检出率。
比较模块30,用于将当前检出率与期望检出率进行比较;以及,
然后将当前设定时间段内基于该初始检出阈值得到的当前检出率与期望检出率进行比较,确定当前检出率是否达到期望检出率。这里的比较可以是大小的简单比较,也可以是当前检出率与期望检出率的设定范围进行比较,判断当前检出率是否落入期望检出率的设定范围内。
检测模块20,还用于如果当前检出率不在期望检出率的设定范围内,则自适应修改初始检出阈值继续进行采样信号闭环检测,直至当前检出率在期望检出率的设定范围内;
如果当前检出率不在期望检出率的设定范围内,则修改当初设置的初始检出阈值后,继续采用修改后的初始检出阈值继续进行采样信号闭环检测,在得到新的当前设定时间段内的当前检出率后,再与期望检出率进行比较,直至当前检出率在期望检出率的设定范围内后,停止修改初始检出阈值。
设置模块10,还用于将最新修改后的初始检出阈值作为目标检出阈值。
停止修改初始检出阈值后,将最新修改后的初始检出阈值作为目标检出阈值在接下来来的设定时间段内进行采样信号闭环检测。
通过上述技术方案,本申请提供的一种植入式电刺激系统在设置期望检出率和初始检出阈值后,基于初始检出阈值在当前设定时间段内进行采样信号闭环检测,该当前设定时间段结束后得到当前检出率。接下来将当前检出率与期望检出率进行比较;如果当前检出率不在期望检出率的设定范围内,则自适应修改初始检出阈值继续进行采样信号闭环检测,直至当前检出率在期望检出率的设定范围内;最后将最新修改后的初始检出阈值作为目标检出阈值。在得到目标检出阈值后,可以采用该目标检出阈值在接下来的设定时间段内进行采样信号闭环检测,以便可以获取期望检出率。可以看出,该自适应检测方式可以提高信号检测的检出率,从而能够准确检测出病症,对病症及时进行干预。
实施例四
本说明书实施例提供的一种存储介质,用于计算机可读存储,所述存储介质存储有一个或者多个程序,所述一个或者多个程序可被一个或者多个处理器执行时,实现如图1至图5所示的自适应闭环检测方法的步骤,具体包括:
步骤10:设置期望检出率和初始检出阈值;
首先设置期望检出率,该期望检出率是在接下来进行采样信号闭环检测的当前设定时间段内希望得到的期望检出率。期望检出率可以根据患者病症的实际情况进行设置,比如当前设定时间段是一周,医生可以设置当前设定时间段内检出癫痫的期望检出率可以为80%。可以将该期望检出率存储在植入式电刺激装置中微控制单元的存储芯片中。本申请提到的植入式电刺激装置主要包括采样电路、微控制单元和刺激电路,采样电路通过电极触点与脑组织接触,通过电极采集植入位置的脑电信号作为采样信号,并将该采样信号传输至微控制单元。微控制单元协调植入式电刺激装置中各个部件的相互协作,并对采样信号进行处理后根据处理结果调节刺激电路发出的电脉冲信号。刺激电路通过电极触点与脑组 织接触,在接收到微控制单元发出的调整指令和电刺激指令后,发送电脉冲至电极所植入的位置。
本说明书实施例提供的自适应闭环检测方法可以适用于在检测过程中根据采样信号的判断及时或者提前发现病症的出现,可以提高信号检测的检出率,准确检测出病症。
初始检出阈值可以是医生根据经验数据得到的期望检出率和初始检出阈值的对应关系表获取,也可以是根据经验数据直接设置初始检出阈值。该初始检出阈值是经验值,由于不同患者的个体差异,该初始检出阈值不够合适,并不能够基于采集的采样信号能够准确检出病症,需要对该初始检出阈值进一步优化,满足不同患者的个体差异,提高检出率。
在不确定初始检出阈值是否合适的情况下,可以取初始检出阈值的一半作为初始检出阈值进行采样信号的检测。
步骤20:基于初始检出阈值在当前设定时间段内进行采样信号闭环检测,得到当前检出率;
在确定好初始检出阈值后,基于该初始检出阈值在当前设定时间段内进行采样信号闭环检测,当采样信号超出该初始检出阈值时,则将当前检出次数增加一次,直至当前设定时间段结束,统计得到当前检出率。
步骤30:将当前检出率与期望检出率进行比较;
然后将当前设定时间段内基于该初始检出阈值得到的当前检出率与期望检出率进行比较,确定当前检出率是否达到期望检出率。这里的比较可以是大小的简单比较,也可以是当前检出率与期望检出率的设定范围进行比较,判断当前检出率是否落入期望检出率的设定范围内。
步骤40:如果当前检出率不在期望检出率的设定范围内,则自适应修改初始检出阈值继续进行采样信号闭环检测,直至当前检出率在期望检出率的设定范围内;
如果当前检出率不在期望检出率的设定范围内,则修改当初设置的初始检出阈值后,继续采用修改后的初始检出阈值继续进行采样信号闭环检测,在得到新的当前设定时间段内的当前检出率后,再与期望检出率进行比较,直至当前检出率在期望检出率的设定范围内后,停止修改初始检出阈值。
步骤50:将最新修改后的初始检出阈值作为期望检出率对应的目标检出阈值。
停止修改初始检出阈值后,将最新修改后的初始检出阈值作为目标检出阈值在接下来来的设定时间段内进行采样信号闭环检测。
通过上述技术方案,本申请提供的一种用于植入式电刺激装置的自适应闭环检测方法, 首先设置期望检出率和初始检出阈值后,基于初始检出阈值在当前设定时间段内进行采样信号闭环检测,该当前设定时间段结束后得到当前检出率。接下来将当前检出率与期望检出率进行比较;如果当前检出率不在期望检出率的设定范围内,则自适应修改初始检出阈值继续进行采样信号闭环检测,直至当前检出率在期望检出率的设定范围内;最后将最新修改后的初始检出阈值作为目标检出阈值。在得到目标检出阈值后,可以采用该目标检出阈值在接下来的设定时间段内进行采样信号闭环检测,以便可以获取期望检出率。可以看出,该自适应检测方式可以提高信号检测的检出率,从而能够准确检测出病症,对病症及时进行干预。
总之,以上所述仅为本说明书的较佳实施例而已,并非用于限定本说明书的保护范围。凡在本说明书的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本说明书的保护范围之内。
上述一个或多个实施例阐明的系统、装置、模块或单元,具体可以由计算机芯片或实体实现,或者由具有某种功能的产品来实现。一种典型的实现设备为计算机。具体的,计算机例如可以为个人计算机、膝上型计算机、蜂窝电话、相机电话、智能电话、个人数字助理、媒体播放器、导航设备、电子邮件设备、游戏控制台、平板计算机、可穿戴设备或者这些设备中的任何设备的组合。
计算机可读存储介质包括永久性和非永久性、可移动和非可移动媒体可以由任何方法或技术来实现信息存储。信息可以是计算机可读指令、数据结构、程序的模块或其他数据。计算机的存储介质的例子包括,但不限于相变内存(PRAM)、静态随机存取存储器(SRAM)、动态随机存取存储器(DRAM)、其他类型的随机存取存储器(RAM)、只读存储器(ROM)、电可擦除可编程只读存储器(EEPROM)、快闪记忆体或其他内存技术、只读光盘只读存储器(CD-ROM)、数字多功能光盘(DVD)或其他光学存储、磁盒式磁带,磁带磁磁盘存储或其他磁性存储设备或任何其他非传输介质,可用于存储可以被计算设备访问的信息。按照本文中的界定,计算机可读介质不包括暂存电脑可读媒体(transitory media),如调制的数据信号和载波。
还需要说明的是,术语“包括”、“包含”或者其任何其他变体意在涵盖非排他性的包含,从而使得包括一系列要素的过程、方法、商品或者设备不仅包括那些要素,而且还包括没有明确列出的其他要素,或者是还包括为这种过程、方法、商品或者设备所固有的要素。在没有更多限制的情况下,由语句“包括一个……”限定的要素,并不排除在包括所述要素的过程、方法、商品或者设备中还存在另外的相同要素。
本说明书中的各个实施例均采用递进的方式描述,各个实施例之间相同相似的部分互相参见即可,每个实施例重点说明的都是与其他实施例的不同之处。尤其,对于系统实施例而言,由于其基本相似于方法实施例,所以描述的比较简单,相关之处参见方法实施例的部分说明即可。
上述对本说明书特定实施例进行了描述。其它实施例在所附权利要求书的范围内。在一些情况下,在权利要求书中记载的动作或步骤可以按照不同于实施例中的顺序来执行并且仍然可以实现期望的结果。另外,在附图中描绘的过程不一定要求示出的特定顺序或者连续顺序才能实现期望的结果。在某些实施方式中,多任务处理和并行处理也是可以的或者可能是有利的。

Claims (10)

  1. 一种用于植入式电刺激装置的自适应闭环检测方法,包括:
    设置期望检出率和初始检出阈值;
    基于所述初始检出阈值在当前设定时间段内进行采样信号闭环检测,得到当前检出率;
    将所述当前检出率与所述期望检出率进行比较;
    如果所述当前检出率不在所述期望检出率的设定范围内,则自适应修改所述初始检出阈值继续进行采样信号闭环检测,直至所述当前检出率在所述期望检出率的所述设定范围内;
    将最新修改后的所述初始检出阈值作为目标检出阈值。
  2. 如权利要求1所述的自适应闭环检测方法,如果所述当前检出率不在所述期望检出率的设定范围内,则自适应修改所述初始检出阈值继续进行采样信号闭环检测,具体包括:
    如果所述当前检出率小于所述期望检出率的所述设定范围的下限值时,将所述初始检出阈值除去一半;
    基于修改后的所述初始检出阈值进行采样信号闭环检测。
  3. 如权利要求1所述的自适应闭环检测方法,如果所述当前检出率不在所述期望检出率的设定范围内,则自适应修改所述初始检出阈值继续进行脑电信号检测,具体包括:
    如果所述当前检出率大于所述期望检出率的所述设定范围的上限值时,将所述初始检出阈值增大一倍;
    基于修改后的所述初始检出阈值进行采样信号闭环检测。
  4. 如权利要求1至3中任一项所述的自适应闭环检测方法,将所述当前检出率与所述期望检出率进行比较之后,所述方法,还包括:
    如果所述当前检出率在所述期望检出率的所述设定范围内,则将所述初始检出阈值作为所述目标检出阈值。
  5. 一种植入式电刺激装置,包括:
    设置模块,用于设置期望检出率和初始检出阈值;
    检测模块,用于基于所述初始检出阈值在当前设定时间段内进行采样信号闭环检测,得到当前检出率;
    比较模块,用于将所述当前检出率与所述期望检出率进行比较;以及,
    所述检测模块,还用于如果所述当前检出率不在所述期望检出率的设定范围内,则自适应修改所述初始检出阈值继续进行采样信号闭环检测,直至所述当前检出率在所述期望检出率的所述设定范围内;
    所述阈值获取模块,还用于将最新修改后的所述初始检出阈值作为目标检出阈值。
  6. 如权利要求5所述的装置,所述检测模块,具体用于:
    如果所述当前检出率小于所述期望检出率的所述设定范围的下限值时,将所述初始检出阈值除去一半;
    基于修改后的所述初始检出阈值进行采样信号闭环检测。
  7. 如权利要求5所述的装置,所述检测模块,还具体用于:
    如果所述当前检出率大于所述期望检出率的所述设定范围的上限值时,将所述初始检出阈值增大一倍;
    基于修改后的所述初始检出阈值进行采样信号闭环检测。
  8. 如权利要求5至7中任一项所述的装置,所述阈值获取模块,在将所述当前检出率与所述期望检出率进行比较之后,还用于:
    如果所述当前检出率在所述期望检出率的所述设定范围内,则将所述初始检出阈值作为所述目标检出阈值。
  9. 一种植入式电刺激系统,所述系统包括外部设备和如权利要求5至8中任一项所述的植入式电刺激装置,所述外部设备与所述植入式电刺激装置通信连接。
  10. 一种存储介质,用于计算机可读存储,所述存储介质存储有一个或者多个程序,所述一个或者多个程序可被一个或者多个处理器执行时,实现如权利要求1至4中任一项所述的自适应闭环检测方法的步骤。
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