WO2023098896A1 - 一种用于脉冲消融的闭环控制*** - Google Patents

一种用于脉冲消融的闭环控制*** Download PDF

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WO2023098896A1
WO2023098896A1 PCT/CN2022/136315 CN2022136315W WO2023098896A1 WO 2023098896 A1 WO2023098896 A1 WO 2023098896A1 CN 2022136315 W CN2022136315 W CN 2022136315W WO 2023098896 A1 WO2023098896 A1 WO 2023098896A1
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pulse
signal
electrode
module
main control
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French (fr)
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陈永刚
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杭州睿笛生物科技有限公司
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206—Generators therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00642—Sensing and controlling the application of energy with feedback, i.e. closed loop control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/0072—Current
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/00767—Voltage
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00839—Bioelectrical parameters, e.g. ECG, EEG

Definitions

  • the present disclosure relates to the field of medical devices, in particular to a closed-loop control system for pulse ablation for treating arrhythmia atrial fibrillation.
  • the ablation therapy for tachyarrhythmia is to destroy the myocardial tissue that causes arrhythmia through minimally invasive ablation.
  • Minimally invasive ablation is used to treat atrioventricular (node) reentry tachycardia, atrial flutter, atrial fibrillation tachyarrhythmia, atrial premature beats and atrial and ventricular premature beats.
  • Radiofrequency current energy is the most commonly used energy source at present.
  • the electrode at the tip of the ablation catheter releases low-voltage high-frequency (30kHz-1.5MHz) radiofrequency energy, and the electric energy is converted into heat energy between the tip of the ablation catheter and the local endocardium to heat the tip of the ablation catheter. , reach 42 °C ⁇ 50 °C, so that specific local myocardial cells dehydration, degeneration, necrosis, self-discipline and conduction properties are changed to radically cure arrhythmia.
  • esophageal injury including esophageal fistula formation, septal nerve injury, pulmonary vein stenosis, coagulation/thrombus formation, and subsequent thromboembolism resulting in the risk of cerebral embolism.
  • Pulsed electric field ablation uses a DC pulse generator to release a biphasic pulsed electric field with high electric field intensity to form a local high voltage difference, release high electric field non-thermal energy, and selectively act on the myocardial area to achieve irreversible electroporation (IRE) of the plasma membrane of myocardial cells. ), resulting in transmural injury, leakage of cell contents, resulting in myocardial cell death, and long-term fibrous scar formation has the same effect as radiofrequency ablation.
  • IRE irreversible electroporation
  • the myocardial tissue in the strong electric field area is an effective ablation site, which can be precisely regulated to reduce the pressure requirements for the ablation electrode; it is a non-thermal tissue ablation, and the tissue scaffold structure will not be damaged during the ablation process. Influenced by the "heat sink effect" of blood flow, local thrombus will not be ablated. It has a relatively wide therapeutic energy window; it has tissue resistance specificity, and the ablation voltage preferentially damages the myocardium, and has little effect on adjacent tissues such as blood vessels, nerves, and esophagus without damage.
  • the purpose of the present disclosure is to provide a closed-loop control system for pulse ablation, which samples the change range of the potential amplitude signal at the ablation site, adjusts the waveform parameters of the pulse signal output by the pulse sending module according to the change range, and then forms a control closed loop. Real-time dynamic optimization and adjustment of electric pulse parameters and electrode discharge according to the ablation effect.
  • the present application discloses a closed-loop control system for pulse ablation, including an electric pulse host and an electrode group including a plurality of electrodes;
  • the electrical pulse host includes a main control module, a pulse sending module, an electrophysiological signal sampling module, a first An electrode control unit and a second electrode control unit, the main control module is sequentially connected with the pulse sending module, the first electrode control unit, and the electrode group, and the main control module controls the pulse sending module to output pulse signals, which are controlled by the first electrode
  • the unit selects a specific electrode to release the pulse signal; the main control module is sequentially connected with the electrophysiological signal sampling module, the second electrode control unit, and the electrode group.
  • the main control module selects electrodes through the second electrode control unit, and the electrophysiological signal
  • the sampling module samples the electrocardiographic signal, and the electrocardiographic signal refers to the potential amplitude signal between the selected electrodes; the main control module judges the treatment progress according to the sampled electrocardiographic signal, and adjusts the output of the pulse sending module in real time according to the treatment progress pulse signal.
  • the pulse sending module and the electrophysiological signal sampling module work alternately, switching every interval of a heartbeat cycle.
  • the main control module judges the treatment progress according to the sampled ECG signal, and adjusts the pulse signal output by the pulse sending module in real time according to the treatment progress, which means:
  • the main control module controls the pulse sending module to output the pulse signal according to the set voltage amplitude and pulse width;
  • Each subsequent ECG signal sampling is performed, and the newly acquired ECG signal is compared with the previously acquired ECG signal;
  • the ablation process ends until the newly acquired ECG signal reaches the set second threshold.
  • a voltage/current sensor which is used to monitor the arc discharge caused by the position change between the electrodes; when the pulse signal is triggered, the voltage/current sampling is delayed for a certain time; the voltage/current sampling is less than the pulse width
  • the sampling signal is transmitted to the main control module for analysis in real time after analog-to-digital conversion, and arc judgment is carried out by judging the change characteristics of voltage and current.
  • the main control module controls the pulse sending module to release the pulse signal within the ECG refractory period according to the ECG signal.
  • a human-computer interaction module which is connected to the main control module for parameter setting, and the parameters include the voltage amplitude and pulse width of the pulse signal.
  • the pulse sending module includes a high-voltage power supply and a pulse generating circuit, and the pulse generating circuit uses a four-way switch module to realize bidirectional pulses.
  • the main control module implements single-electrode pulse transmission control and single-electrode ECG signal sampling through the first electrode control unit and the second electrode control unit.
  • the application judges the treatment progress during the treatment process, which helps to prevent excessive pulse sending and incomplete treatment.
  • It can detect and feed back cardiac electrophysiological signals while performing high-voltage electric pulse ablation of cardiomyocytes, and adjust the parameters of the pulse waveform in real time.
  • the parameters include voltage amplitude, pulse width, pulse phase and pulse cycle.
  • Fig. 1 is the schematic diagram of the application control system
  • Fig. 2 is a circuit diagram of a pulse sending module
  • Fig. 3 is the switching circuit of the pulse sending module and the electrophysiological signal sampling module
  • Fig. 4 is a current sampling circuit
  • Figure 5 is a voltage sampling circuit.
  • a closed-loop control system for pulse ablation includes an electric pulse host 100 and an electrode group including a plurality of electrodes 200 .
  • One end of the plurality of electrodes 200 passes through the ablation mapping catheter 300 to reach myocardial tissue (ablation site), and the other end receives electrical pulse signals, and conducts the electrical pulse signals to the ablation site.
  • the electrical pulse host 100 includes a main control module 110 , a pulse sending module 120 , an electrophysiological signal sampling module 130 , a first electrode control unit 140 and a second electrode control unit 150 .
  • the electric pulse host 100 includes two control circuits, one is a control circuit, which is composed of a main control module 110, a pulse transmission module 120, a first electrode control unit 140, and an electrode group connected in sequence, and the main control module 110 controls the pulse transmission module 120 to output pulse signals , the first electrode control unit 140 selects a specific electrode to release the pulse signal to act on the ablation site.
  • the other circuit is a feedback circuit, which is composed of the main control module 110 connected with the electrophysiological signal sampling module 130, the second electrode control unit 150, and the electrode group in sequence.
  • the sampling module 130 samples the ECG signal
  • the main control module 110 judges the treatment progress according to the sampled ECG signal, and adjusts the pulse signal output by the pulse sending module 120 in real time according to the treatment progress.
  • the main control module can also realize single-electrode pulse transmission control and single-electrode ECG signal sampling through the first electrode control unit and the second electrode control unit.
  • the pulse sending module includes a high-voltage power supply and a pulse generating circuit.
  • the pulse generating circuit uses a four-way switch module to realize bidirectional pulses. As shown in Figure 2, Q1 and Q4 are turned on, and the terminal sends out positive pulse waves. Q2 and Q3 are turned on, and the terminal sends out negative pulse. By controlling the conduction time of Q1 and Q4, the positive pulse width can be controlled, and the negative pulse width can be controlled by controlling the conduction time of Q2 and Q3.
  • the pulse width adjustment range is 500ns–50us.
  • the period can be controlled by controlling the interval between two positive pulses, and the pulse period can be adjusted between 1us and 10ms as required.
  • the phase can be controlled by controlling the time interval between the positive-going pulse and the negative-going pulse.
  • the pulse phase can be adjusted between 500ns and 5us.
  • the pulse sending module 120 and the electrophysiological signal sampling module 130 work alternately, switching every interval of a heartbeat cycle, and through switching the relays of the corresponding electrodes, single-electrode pulse sending control and single-electrode signal sampling can be realized.
  • the main control module 110 controls the pulse sending module 120 to release the pulse signal within the ECG refractory period according to the ECG signal.
  • the switch contacts of J1 and J2 high-voltage vacuum relays are switched from normally closed contacts to normally open contacts, and the electrophysiological signal sampling module 130 is disconnected from the main circuit.
  • J1 and J2 are in normally closed contact, and the pulse sending module 120 is disconnected from the main circuit.
  • the electrocardiographic signal sampling module samples the electrocardiographic signal at the ablation site through electrodes to judge the therapeutic effect.
  • the first electrode control unit 140 includes a plurality of relays P_1 to P_n, P_1 to P_n are high-voltage vacuum relays, the number n of relays is consistent with the number of electrodes, and each relay corresponds to an electrode, which is the same as The electrode is connected to the positive pole, and the group of relays is used to control the positive pole of the electric pulse;
  • the second electrode control unit 150 includes a plurality of relays N_1 to N_n, N_1 to N_n are high-voltage vacuum relays, and the number n of relays is consistent with the number of electrodes, and each relay corresponds to One electrode is connected with the negative pole of the electrode, and the group of relays is used to control the negative pole of the electric pulse.
  • the main control module 110 judges the treatment progress according to the sampled ECG signal, and adjusts the pulse signal output by the pulse sending module 120 in real time according to the treatment progress, wherein the ECG signal refers to the potential amplitude signal between the selected electrodes, from two Adjacent signals start to be detected, for example, between 1 electrode and 2 electrode, 2 electrode and 3 electrode, 3 electrode and 4 electrode, until between n-1 electrode and n electrode.
  • the ECG signal refers to the potential amplitude signal between the selected electrodes, from two Adjacent signals start to be detected, for example, between 1 electrode and 2 electrode, 2 electrode and 3 electrode, 3 electrode and 4 electrode, until between n-1 electrode and n electrode.
  • the main control module 110 controls the pulse sending module 120 to output according to the set voltage amplitude and pulse width Pulse signal (input by human-computer interaction module 170);
  • the ECG signal will continue to decline, that is, the potential amplitude signal measured by the electrode will gradually decrease. If the newly acquired ECG signal does not change, it means that the current electrode The position you are in may not be the best position and needs to be adjusted. When the ECG signal drops, it is necessary to compare the drop amount and the drop amplitude to calculate the percentage change, and adjust the voltage amplitude or pulse number of the pulse signal according to the percentage change. When the newly acquired ECG signal reaches or falls below the set second threshold (generally 0.5mV), it indicates that the ablation process is over.
  • the set second threshold generally 0.5mV
  • control system in this embodiment further includes a voltage/current sensor 160 for monitoring the arc discharge caused by the position change between the electrodes. Arcing causes high ionized gas pressures and the creation of air bubbles that follow the blood to the lungs and are dangerous.
  • the voltage/current sensor 160 is located before the J1 and J2 high voltage vacuum relays.
  • a separate voltage and current sampling module may be provided, or the voltage and current sampling module may be integrated in the main control module 110 .
  • the voltage/current signal is collected in real time by the voltage/current sensor 160, and the collected signal is transmitted to the main control module 110, and then the wavelet transform is used to monitor in real time whether there is electrode short circuit, open circuit and sparking phenomenon, and if abnormality is found, it is cut off in time.
  • the current sampling circuit is shown in Figure 4 below.
  • the current sensor obtains the analog value of the output part of the current value, and enters the analog-to-digital conversion chip after passing through the op amp modulation circuit. After the signal is digitized, it is sent to the CPLD for processing through timing control.
  • the voltage sampling circuit is shown in Figure 5 below.
  • the sampling differential circuit realizes the processing from high voltage to low voltage. After the voltage signal is modulated and attenuated by a certain percentage, it is directly transmitted to the analog-to-digital conversion interface of the main control module 110MCU.
  • the electrode arc detection is carried out by the following method.
  • the pulse signal is triggered, the voltage/current sampling is delayed for a certain period of time; the voltage/current sampling is carried out at a time less than the pulse width (1%), and the sampling signal is transmitted to the
  • the main control module 110 conducts analysis, specifically, when an arc occurs, the voltage drops and the current rises, and the arc can be judged by judging the variation characteristics of the voltage and current.
  • control system in this embodiment further includes a human-computer interaction module 170, which is connected to the main control module 110 for parameter setting, and the parameters include the voltage amplitude and pulse width of the pulse signal.

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Abstract

一种用于脉冲消融的闭环控制***，包括电脉冲主机（100）和电极组。电脉冲主机（100）包括两路控制，一路为控制电路，由主控模块（110）与脉冲发送模块（120）、第一电极控制单元（140）、电极组依次连接组成，主控模块（110）控制脉冲发送模块（120）输出脉冲信号，通过第一电极控制单元（140）选择特定的电极释放脉冲信号，作用于消融部位。另一路为反馈电路，由主控模块（110）与电生理信号采样模块（130）、第二电极控制单元（150）、电极组依次连接组成，主控模块（110）通过第二电极控制单元（150）选择电极（200），通过电生理信号采样模块（130）采样心电信号，主控模块（110）根据所采样的心电信号判断治疗进度，根据治疗进度实时调节脉冲发送模块（120）输出的脉冲信号。

Description

一种用于脉冲消融的闭环控制*** 技术领域
本公开涉及医疗器械领域，特别涉及一种用于脉冲消融的闭环控制***，用于治疗心律失常心房颤动。
背景技术
快速心律失常的消融治疗是通过微创消融的方法，损毁导致心律失常发生的心肌组织。微创消融术用于治疗房室(结)折返性心动过速，心房扑动，心房颤动快速心律失常及房性早搏和房性、室性早搏。
射频电流能量是目前最常用的能源，消融导管头端的电极释放低电压高频(30kHz～1.5MHz)射频电能，在消融导管头端与局部心肌内膜之间电能转化为热能加热消融导管头端，达到42℃～50℃，使特定的局部心肌细胞脱水、变性、坏死，自律性和传导性能均发生改变根治心律失常。由于热传导特性，容易对靶向心肌组织及其周围其他组织结构产生不良影响，导致食道损伤包括食管瘘形成，隔神经损伤，肺静脉狭窄，凝结物/血栓形成以及随后的血栓栓塞造成脑栓塞风险。
脉冲电场消融通过直流电脉冲发生器释放高电场强度的双相脉冲电场，形成局部高电压差，释放高电场的非热能量，选择性作用于心肌区域实现心肌细胞质膜不可逆电穿孔(irreversible electroporation，IRE)，造成透壁损伤，细胞内容物泄露，导致心肌细胞死亡，远期纤维疤痕形成和射频消融效果相同。脉冲电场消融强电场区域内的心肌组织均是有效消融位点，可精准调控，降低对消融电极贴靠压力的要求；为非热能组织消融，在消融过程中不会破坏组织支架结构，不受血流“热沉效应”的影响，不会产生消融局部血栓。具有相对较宽的治疗能量窗口；具有组织电阻特异性，消融电压优先损伤心肌，对血管、神经、食道等邻近组织影响极小且不会损伤。
目前电脉冲发生器大多工作在开环状态，只能实施电脉冲的实时发送， 无法根据消融效果对电脉冲参数及电极放电进行实时动态优化调整，增加了治疗中的风险。
发明内容
本公开的目的在于提供一种用于脉冲消融的闭环控制***，采样消融部位处电位幅值信号的变化幅度，根据变化幅度对应调整脉冲发送模块输出的脉冲信号的波形参数，继而形成控制闭环，根据消融效果对电脉冲参数及电极放电进行实时动态优化调整。
本申请公开了一种用于脉冲消融的闭环控制***，包括电脉冲主机，和包括多个电极的电极组；所述电脉冲主机包括主控模块、脉冲发送模块、电生理信号采样模块、第一电极控制单元以及第二电极控制单元，所述主控模块与脉冲发送模块、第一电极控制单元、电极组依次连接，所述主控模块控制脉冲发送模块输出脉冲信号，通过第一电极控制单元选择特定的电极释放脉冲信号；所述主控模块与电生理信号采样模块、第二电极控制单元、电极组依次连接，所述主控模块通过第二电极控制单元选择电极，通过电生理信号采样模块采样心电信号，所述心电信号是指所选择电极之间的电位幅值信号；所述主控模块根据所采样的心电信号判断治疗进度，根据治疗进度实时调节脉冲发送模块输出的脉冲信号。
进一步地，所述脉冲发送模块和电生理信号采样模块交替工作，每间隔一个心跳周期进行一次切换。
进一步地，所述主控模块根据所采样的心电信号判断治疗进度，根据治疗进度实时调节脉冲发送模块输出的脉冲信号，是指：
进行第一次心电信号采样时，若采样所得的心电信号A大于第一阈值，则主控模块控制脉冲发送模块按照设定的电压幅值和脉宽输出脉冲信号；
后续每进行一次心电信号采样，将新采得的心电信号与前一次采得的心电信号进行比较；
若新采得的心电信号没有发生变化，则说明对应电极所处的位置需要调整；
若新采得的心电信号有变化，则计算变化幅度，根据所述变化幅度对应 调整脉冲发送模块输出的脉冲信号的波形参数；
直至新采得的心电信号达到设定的第二阈值，消融过程结束。
进一步地，还包括电压/电流传感器，用于对电极之间因位置变化而导致的电弧放电进行监测；当脉冲信号触发后，延迟一定时间进行电压/电流采样；电压/电流采样以小于脉宽的时间进行，采样信号经模数转换后实时传输到主控模块进行分析，通过判断电压、电流的变化特性进行电弧判断。
进一步地，所述主控模块根据心电信号控制脉冲发送模块在心电不应期内释放脉冲信号。
进一步地，还包括人机交互模块，人机交互模块与主控模块连接，用于进行参数设置，参数包括脉冲信号的电压幅值和脉宽。
进一步地，所述脉冲发送模块包括高压电源和脉冲发生电路，所述脉冲发生电路采用四路开关模块实现双向脉冲。
进一步地，所述主控模块通过第一电极控制单元、第二电极控制单元实现单电极脉冲发送控制和单电极的心电信号采样。
有益效果：(1)、本申请根据电生理信号采样模块的数据反馈，在治疗过程中就在判断治疗进度，有助于防止过度的脉冲发送和不完全的治疗。(2)、可以在进行高压电脉冲消融心肌细胞的同时进行心脏电生理信号的检测和反馈，实时调整作用的脉冲波形参数，参数包括电压幅值、脉宽、脉冲相位以及脉冲脉冲周期。(3)对电极之间因位置变化而导致的电弧放电进行监测，防止异常电弧的产生，使设备治疗更具安全性。
上述发明内容中公开的各个技术特征、在下文各个实施方式和例子中公开的各技术特征、以及附图中公开的各个技术特征，都可以自由地互相组合，从而构成各种新的技术方案(这些技术方案均应该视为在本说明书中已经记载)，除非这种技术特征的组合在技术上是不可行的。
附图说明
图1是本申请控制***的示意图；
图2是脉冲发送模块电路图；
图3是脉冲发送模块和电生理信号采样模块切换电路；
图4是电流采样电路；
图5是电压采样电路。
具体实施方式
在以下的叙述中，为了使读者更好地理解本申请而提出了许多技术细节。但是，本领域的普通技术人员可以理解，即使没有这些技术细节和基于以下各实施方式的种种变化和修改，也可以实现本申请所要求保护的技术方案。
为使本申请的目的、技术方案和优点更加清楚，下面将结合附图对本申请的实施方式作进一步地详细描述。
一种用于脉冲消融的闭环控制***，包括电脉冲主机100，和包括多个电极200的电极组。多个电极200一端穿过消融标测导管300达到心肌组织(消融部位)，另一端接收电脉冲信号，将电脉冲信号传导至消融部位。
如图1所示，电脉冲主机100包括主控模块110、脉冲发送模块120、电生理信号采样模块130、第一电极控制单元140以及第二电极控制单元150。电脉冲主机100包括两路控制，一路为控制电路，由主控模块110与脉冲发送模块120、第一电极控制单元140、电极组依次连接组成，主控模块110控制脉冲发送模块120输出脉冲信号，通过第一电极控制单元140选择特定的电极释放脉冲信号，作用于消融部位。另一路为反馈电路，由主控模块110与电生理信号采样模块130、第二电极控制单元150、电极组依次连接组成，主控模块110通过第二电极控制单元150选择电极，通过电生理信号采样模块130采样心电信号，主控模块110根据所采样的心电信号判断治疗进度，根据治疗进度实时调节脉冲发送模块120输出的脉冲信号。主控模块还可以通过第一电极控制单元、第二电极控制单元实现单电极脉冲发送控制和单电极的心电信号采样。
脉冲发送模块包括高压电源和脉冲发生电路，脉冲发生电路采用四路开关模块实现双向脉冲，如图2所示，Q1和Q4导通，终端发出正向脉冲波，Q2和Q3导通，终端发出负向脉冲波。通过控制Q1和Q4导通的时间，就可以控制正向脉冲宽度，控制Q2和Q3导通的时间，就可以控制负向的脉冲宽度。脉冲宽度调节范围为500ns–50us。通过控制两个正向脉冲的间隔时间就 可以控制周期，脉冲周期可以根据需要在1us到10ms之间调整。通过控制正向脉冲和负向脉冲的时间间隔就可以控制相位。脉冲相位可以在500ns到5us之间调整。
脉冲发送模块120和电生理信号采样模块130交替工作，每间隔一个心跳周期进行一次切换，通过对应电极的继电器切换，可以实现单电极脉冲发送控制和单电极的信号采样。主控模块110根据心电信号控制脉冲发送模块120在心电不应期内释放脉冲信号。如图3所示，当需要脉冲发送时，J1和J2高压真空继电器开关触点从常闭触点切换到常开触点，电生理信号采样模块130从主电路中脱离。当需要采样电极处电信号时，J1和J2处于常闭触点，脉冲发送模块120从主电路中脱离。可通过后端继电器来选择特定的电极。心电信号采样模块通过电极采样消融部位处的心电信号，判断治疗效果。本实施例中，如图3所示，第一电极控制单元140包括多个继电器P_1到P_n，P_1到P_n为高压真空继电器，继电器数n和电极数一致，每个继电器对应一个电极，与电极正极连接，该组继电器用来进行电脉冲正极控制；第二电极控制单元150包括多个继电器N_1到N_n，N_1到N_n为高压真空继电器，继电器数n和电极数一致，每个继电器对应一个电极，与电极负极连接，该组继电器用来进行电脉冲负极控制。心电信号检测时，可以任意选择1到n中的两个电极间电位，也可以通过循环扫描实现，当检测到电信号小于0.5mV后，脉冲发送停止。
主控模块110根据所采样的心电信号判断治疗进度，根据治疗进度实时调节脉冲发送模块120输出的脉冲信号，其中，心电信号是指所选择电极之间的电位幅值信号，从两个相邻信号开始检测，例如，1电极和2电极，2电极和3电极，3电极和4电极，一直到n-1电极到n电极之间。具体包括，
(1)进行第一次心电信号采样时，若采样所得的心电信号A大于第一阈值(5mV)，则主控模块110控制脉冲发送模块120按照设定的电压幅值和脉宽输出脉冲信号(由人机交互模块170输入)；
(2)后续每进行一次心电信号采样，将新采得的心电信号与前一次采得的心电信号进行比较；心电采样的频率和一个消融周期对应；
若新采得的心电信号没有发生变化，则说明对应电极所处的位置需要调整；
若新采得的心电信号有变化，则计算变化幅度，根据变化幅度对应调整脉冲发送模块120输出的脉冲信号的波形参数；直至新采得的心电信号达到设定的第二阈值，消融过程结束。
其中，临床数据显示，随着消融过程的进行，心电信号会持续下降，即电极测得的电位幅值信号会逐渐减小，若新采得的心电信号没有发生变化，则说明当前电极所处的位置可能不是最佳位置，需要调整。当心电信号下降，则需要对下降量和下降幅值进行比较计算变化幅度百分比，按照变化幅度百分比对脉冲信号的电压幅值或是脉冲个数进行调整。当新采得的心电信号达到设定的第二阈值(一般为0.5mV)或以下，则说明消融过程结束。
此外，本实施例中控制***还包括电压/电流传感器160，用于对电极之间因位置变化而导致的电弧放电进行监测。电弧放电会导致很高的电离气压，气泡的产生，气泡跟随血液流动到肺部非常危险。如图2所示，电压/电流传感器160位于J1和J2高压真空继电器之前。可设置单独的电压电流采样模块，也可以将电压电流采样模块集成在主控模块110中。通过电压/电流传感器160实时采集电压/电流信号，采集到的信号传入主控模块110后通过小波变换实时监测是否有电极短路、开路及打火现象的发生，发现异常，及时切断。电流采样电路如下图4所示，电流传感器获取输出部分电流值模拟量，通过运放调制电路后进入模数转换芯片，信号数字化后通过时序控制传入CPLD处理。电压采样电路如下图5所示，采样差分电路的方式，实现了从高压到低压的处理，电压信号经过调制和一定比例衰减后直接传入主控模块110MCU的模数转换接口。
对电极电弧检测通过以下方法进行，当脉冲信号触发后，延迟一定时间进行电压/电流采样；电压/电流采样以小于脉宽(1％)的时间进行，采样信号经模数转换后实时传输到主控模块110进行分析，具体地，当电弧发生时，电压下降，电流会上升，通过判断电压、电流的变化特性就可以进行电弧判断。
此外，本实施例中控制***还包括人机交互模块170，人机交互模块170与主控模块110连接，用于进行参数设置，参数包括脉冲信号的电压幅值和脉宽。
以上所述仅为本发明的较佳实施例，并不用以限制本发明的保护范围，凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。

Claims (8)

  1. 一种用于脉冲消融的闭环控制***，其特征在于，包括电脉冲主机和电极组，电极组包括多个电极；
    所述电脉冲主机包括主控模块、脉冲发送模块、电生理信号采样模块、第一电极控制单元以及第二电极控制单元；
    所述主控模块与脉冲发送模块、第一电极控制单元、电极组依次连接，所述主控模块控制脉冲发送模块输出脉冲信号，通过第一电极控制单元选择特定的电极释放脉冲信号；
    所述主控模块与电生理信号采样模块、第二电极控制单元、电极组依次连接，所述主控模块通过第二电极控制单元选择电极，通过电生理信号采样模块采样心电信号，所述心电信号是指所选择电极之间的电位幅值信号；所述主控模块根据所采样的心电信号判断治疗进度，根据治疗进度实时调节脉冲发送模块输出的脉冲信号。
  2. 根据权利要求1所述的一种用于脉冲消融的闭环控制***，其特征在于，所述脉冲发送模块和电生理信号采样模块交替工作，每间隔一个心跳周期进行一次切换。
  3. 根据权利要求1所述的一种用于脉冲消融的闭环控制***，其特征在于，所述主控模块通过第一电极控制单元、第二电极控制单元实现单电极脉冲发送控制和单电极的心电信号采样。
  4. 根据权利要求1或2或3所述的一种用于脉冲消融的闭环控制***，其特征在于，所述主控模块根据所采样的心电信号判断治疗进度，根据治疗进度实时调节脉冲发送模块输出的脉冲信号，是指：进行第一次心电信号采 样时，若采样所得的心电信号A大于第一阈值，则主控模块控制脉冲发送模块按照设定的电压幅值和脉宽输出脉冲信号；
    后续每进行一次心电信号采样，将新采得的心电信号与前一次采得的心电信号进行比较；
    若新采得的心电信号没有发生变化，则说明对应电极所处的位置需要调整；
    若新采得的心电信号有变化，则计算变化幅度，根据所述变化幅度对应调整脉冲发送模块输出的脉冲信号的波形参数；
    直至新采得的心电信号达到设定的第二阈值，消融过程结束。
  5. 根据权利要求1所述的一种用于脉冲消融的闭环控制***，其特征在于，还包括电压/电流传感器，用于对电极之间因位置变化而导致的电弧放电进行监测；
    当脉冲信号触发后，延迟一定时间进行电压/电流采样；
    电压/电流采样以小于脉宽的时间进行，采样信号经模数转换后实时传输到主控模块进行分析，通过判断电压、电流的变化特性进行电弧判断。
  6. 根据权利要求1所述的一种用于脉冲消融的闭环控制***，其特征在于，所述主控模块根据心电信号控制脉冲发送模块在心电不应期内释放脉冲信号。
  7. 根据权利要求1所述的一种用于脉冲消融的闭环控制***，其特征在于，还包括人机交互模块，人机交互模块与主控模块连接，用于进行参数设置，参数包括脉冲信号的电压幅值和脉宽。
  8. 根据权利要求1所述的一种用于脉冲消融的闭环控制***，其特征在 于，所述脉冲发送模块包括高压电源和脉冲发生电路，所述脉冲发生电路采用四路开关模块实现双向脉冲。
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