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WO2023277488A1 - Système d'électroporation irréversible et procédé d'application d'impulsions correspondant - Google Patents

Système d'électroporation irréversible et procédé d'application d'impulsions correspondant Download PDF

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Publication number
WO2023277488A1
WO2023277488A1 PCT/KR2022/009141 KR2022009141W WO2023277488A1 WO 2023277488 A1 WO2023277488 A1 WO 2023277488A1 KR 2022009141 W KR2022009141 W KR 2022009141W WO 2023277488 A1 WO2023277488 A1 WO 2023277488A1
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Prior art keywords
pulse
voltage
current
high voltage
level
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PCT/KR2022/009141
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English (en)
Korean (ko)
Inventor
김성남
김홍배
정세웅
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Standard Co Ltd
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Standard Co Ltd
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Priority claimed from KR1020210084859A external-priority patent/KR102343921B1/ko
Priority claimed from KR1020210084870A external-priority patent/KR102346167B1/ko
Priority claimed from KR1020210084844A external-priority patent/KR102326448B1/ko
Application filed by Standard Co Ltd filed Critical Standard Co Ltd
Publication of WO2023277488A1 publication Critical patent/WO2023277488A1/fr
Anticipated expiration legal-status Critical
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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
    • 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
    • A61B18/14—Probes or electrodes therefor

Definitions

  • the present invention relates to an electroporation system, and more particularly, to an irreversible electroporation system capable of stably monitoring an output high voltage, effectively blocking an overcurrent of an output pulse, and inducing an electrochemical reaction.
  • Irreversible Electroporation is a method of cauterizing and removing malignant tumors such as solid cancers in a cell unit by generating a strong electric field between the electrodes by applying a high voltage or high current to both ends of the electrodes. This method is used in a limited range as a new local treatment for patients incapable of surgical treatment due to proximity to major blood vessels and organs.
  • High-frequency electroporation has been proposed to overcome the problems of muscle contraction and electrocardiogram (ECG) disturbance of conventional low-frequency monophase electroporation.
  • ECG electrocardiogram
  • a voltage must be applied twice or more compared to a monophase low frequency pulse.
  • cancer cells at a location where the strength of the electric field is weak between the two electrodes are highly likely to survive. Therefore, there is a need for further research on high-frequency electroporation to provide high cancer cell cauterization efficiency.
  • An object of the present invention is to provide an irreversible electroporation system that stably supplies an output high voltage by detecting or monitoring the output high voltage at a precise value even in various noises.
  • Another object of the present invention is to provide an irreversible electroporation system that calculates an average current free from the effects of current peaks.
  • an irreversible electroporation system capable of setting a limiting current value according to the treatment site or characteristics by providing various limiting current values.
  • Another advantage of the present invention is to provide a high-frequency irreversible electroporation system capable of inducing an electrochemical reaction in addition to the electroporation action.
  • it is to provide a pulse application method of an irreversible electroporation system capable of providing high-frequency pulses of various waveforms capable of varying the efficiency of the electrochemical reaction.
  • An irreversible electroporation system for generating an output high voltage according to an embodiment of the present invention, a boost circuit for generating the output high voltage through a charging operation for an input voltage, the output high voltage output from the boost circuit as a feedback voltage
  • a feedback circuit for converting to a voltage-frequency converter for generating a first detection signal having a frequency that varies according to the level of the feedback voltage, and a boost for controlling the charging operation of the step-up circuit with reference to the first detection signal. and a controller that generates control signals.
  • the irreversible electroporation system further comprises a comparator for generating a second detection signal by comparing the level of the set voltage defining the level of the feedback voltage and the output high voltage.
  • the comparator comprises: a first comparator comparing the feedback voltage with an adjustable first set voltage, a second comparator comparing the feedback voltage with a second set voltage of a fixed level, and the first set voltage. and a digital variable resistor for providing a voltage to the first comparator.
  • the second set voltage corresponds to the maximum value of the first set voltage.
  • the feedback circuit includes a plurality of resistors connected in series for outputting the feedback voltage by voltage-dividing the output high voltage, at least one capacitor connected between the ground and a feedback node from which the feedback voltage is output, and A Zener diode is connected between the feedback node and the ground and stabilizes the feedback voltage.
  • An irreversible electroporation system for generating a high voltage pulse from a pulse signal, a current detector for detecting the current of the high voltage pulse and outputting the detected current, the high voltage pulse to a control signal a high voltage switch that switches according to the voltage and provides a pulse output; and a controller that calculates an average current of the high voltage pulse using the detected current and generates the control signal based on the average current, wherein the controller comprises: The detection current corresponding to the first high voltage pulse before the current level is stabilized when the pulse is generated is excluded from the calculation of the average current.
  • the controller calculates the average current from the detection current corresponding to at least one second high voltage pulse generated after the current level is stabilized, and the controller calculates the average current corresponding to a current peak included in the second high voltage pulse. excluding detection current.
  • the controller outputs the control signal to shut off the high voltage switch when a current peak included in the high voltage pulse is greater than a limiting current.
  • the limiting current is added to or subtracted from the average current by a predetermined current size, and the predetermined current size varies according to a treatment mode to which the pulse output is applied.
  • the high voltage pulse is provided as a monopolar or bipolar waveform.
  • a pulse application method of a high-frequency irreversible electroporation system includes the steps of selecting any one mode to be applied to a target cell among a plurality of pulse modes, during a first period according to the selected pulse mode Applying a first pulse, maintaining a ground level during a second period following the first period, and applying a second pulse during a third period following the second period,
  • the first pulse includes a pulse peak and a pulse decay period, and provides electroporation to the target cell at the pulse peak, and the pulse decay period induces an electrochemical reaction in the target cell.
  • the second pulse is provided with the same waveform as the first pulse but with an opposite polarity.
  • the length of the decay period is set to 1 ⁇ s to 40 ⁇ s.
  • the pulse width is set to 0.5 ⁇ s to 20 ⁇ s.
  • the time constant for setting the length of the decay period is adjusted according to the selected pulse mode.
  • the average value of the current pulse of the irreversible electroporation system can be accurately calculated under various conditions. Therefore, the stability of the irreversible electroporation system can be increased by suppressing the occurrence of sparks in the high voltage pulse output under various conditions.
  • the irreversible electroporation method when applying the irreversible electroporation method, it is possible to implement an irreversible electroporation system capable of inducing an electrochemical action along with the electroporation effect and a method for applying a pulse thereof.
  • an irreversible electroporation system capable of inducing an electrochemical action along with the electroporation effect and a method for applying a pulse thereof.
  • the high-frequency electroporation system and its pulse application method of the present invention it is possible to induce electrochemical action of various effects according to the treatment characteristics, and thus can provide a high therapeutic effect.
  • FIG. 1 is a block diagram exemplarily showing an irreversible electroporation system according to an embodiment of the present invention.
  • FIG. 2 is a block diagram showing the configuration of the booster of FIG. 1 by way of example.
  • FIG. 3 is a circuit diagram showing the feedback circuit and the voltage-frequency converter of FIG. 2 as an example.
  • FIG. 4 is a circuit diagram showing a simplified concept of the comparator of FIG. 2 .
  • FIG. 5 is a timing diagram illustrating an operation of the comparator of FIG. 4 as an example.
  • FIG. 6 is a circuit diagram showing another embodiment of the comparator of FIG. 2 in detail.
  • FIG. 7 is a circuit diagram showing the charging control circuit of FIG. 2 as an example.
  • FIG. 8 is a timing diagram briefly illustrating an operation of the charging control circuit of FIG. 7 .
  • FIG. 9 is a flowchart briefly illustrating a control operation of the controller and the charging control circuit of FIG. 1 .
  • FIG. 10 is a block diagram schematically showing an irreversible electroporation system according to an embodiment of the present invention.
  • FIG. 11 is a timing diagram briefly illustrating a method of calculating an average current using a detected current in the controller of FIG. 10 .
  • FIG. 12 is a timing diagram showing a method of obtaining an average current according to the present invention in more detail.
  • FIG. 13 is a circuit diagram showing the high voltage switch shown in FIG. 10 as an example.
  • FIG. 14 is a timing diagram exemplarily showing a method of blocking overcurrent performed by the controller of the present invention.
  • 15 is a timing diagram exemplarily showing a method of blocking overcurrent for each mode of the present invention.
  • 16 is a timing diagram illustrating a method of blocking overcurrent according to another embodiment of the present invention.
  • Figure 17 is a flow chart briefly showing the overcurrent blocking method of the irreversible electroporation system of the present invention.
  • FIG. 18 is a block diagram schematically showing an irreversible electroporation system according to an embodiment of the present invention.
  • HF_Pulse high-frequency pulses
  • HF_Pulse high frequency pulse
  • FIGS 21 are timing diagrams showing waveforms of high frequency pulses (HF_Pulse) in various modes according to an embodiment of the present invention.
  • HF_Pulse high frequency pulses
  • 22 is a view briefly showing the operation characteristics of the high-frequency electroporation method according to an embodiment of the present invention.
  • FIGS 2, 10 and 20 show the best mode for carrying out the present invention.
  • the irreversible electroporation system 1100 may include a booster 1110 , a controller 1120 , and a probe 1130 .
  • the booster 1110 boosts the input voltage V_in and provides it as an output high voltage HV_out.
  • the booster 1110 may include a charging and boosting circuit for stably boosting the input voltage V_in to a reference voltage or a set voltage level by charging the input voltage V_in.
  • the booster 1110 has a function of feeding back and monitoring the level of the output high voltage HV_out.
  • the booster 1110 monitors the feedback voltage Vfb and controls the charge level according to the level of the output high voltage HV_out. Accordingly, the output high voltage HV_out can be maintained at a stable level.
  • the booster 1110 of the present invention may perform double detection by feeding back the output high voltage HV_out.
  • the booster 1110 may detect the feedback voltage Vfb and generate the first detection signal VF_out and the second detection signal Charge_status.
  • the feedback voltage (Vfb) is a voltage converted to a level that can be measured and managed in an internal circuit by voltage dividing the output high voltage (HV_out).
  • the first detection signal VF_out may be a pulse signal having a variable frequency according to the feedback voltage Vfb.
  • the second detection signal (Charge_status) indicates whether the output high voltage (HV_out) has reached the set voltage by comparing the level of the feedback voltage (Vfb) and the set voltage. That is, the second detection signal Charge_status corresponds to a state value indicating whether the output high voltage HV_out is charged to the target voltage level.
  • the controller 1120 generates a boost control signal (Boost_CTRL) for controlling the charging state of the booster 1110 by referring to the first detection signal (VF_out) and the second detection signal (Charge_status). That is, the controller 1120 may provide stable output characteristics of the booster 1110 through double monitoring of the output high voltage HV_out.
  • the controller 1120 may be implemented using a MICOM or various control units.
  • the probe 1130 may serve as an electrode for applying the output high voltage HV_out to the affected area or tissue.
  • Probe 1130 can be mounted on, for example, an endoscope to access tissue to be operated upon irreversibly electroporation.
  • the above non-reversible electroporation system 1100 of the present invention may perform monitoring by converting the output high voltage (HV_out) into a frequency signal by feeding back.
  • HV_out output high voltage
  • noise present in the output high voltage HV_out can be effectively filtered. Accordingly, a precise detection operation accompanied by noise filtering of the output high voltage HV_out is possible.
  • a booster 1110 may include a charge control circuit 1111, a boost circuit 1112, a feedback circuit 1113, a voltage-frequency converter 1114, and a comparator 1115.
  • the booster 1110 may further include additional components such as an isolation element or a function generator for converting the output high voltage (HV_out) into a pulse waveform for signal transmission stability. will be well understood.
  • the charge control circuit 1111 may control the charging operation of the boost circuit 1112 in response to a boost control signal (Boost_CTRL) provided from the controller 1120 or a second detection signal (Charge_status) provided from the comparator 1115.
  • Boost_CTRL boost control signal
  • the boost control signal Boost_CTRL may be generated by the controller 1120 by the first detection signal VF_out or the second detection signal Charge_status. That is, whether the level of the output high voltage HV_out output from the boost circuit 1112 matches the set voltage can be detected through the first detection signal VF_out and the second detection signal Charge_status.
  • the controller 1120 may output a boost control signal (Boost_CTRL) to disable voltage charging of the boost circuit 1112 when the level of the output high voltage HV_out matches the set voltage.
  • Boost_CTRL boost control signal
  • the controller 1120 when the level of the output high voltage HV_out is lower than the set voltage, the controller 1120 outputs the boost control signal Boost_CTRL to activate voltage charging of the boost circuit 1112.
  • the charge control circuit 1111 may generate a charge control signal Enable to enable/disable the charging operation of the boost circuit 1112 according to the boost control signal Boost_CTRL and the second detection signal Charge_status.
  • the boost circuit 1112 charges the input voltage (V_in) and converts it into an output high voltage (HV_out).
  • the boost circuit 1112 may charge the input voltage V_in in response to the charge control signal Enable provided from the charge control circuit 1111 .
  • the charge control signal Enable is generated from the boost control signal Boost_CTRL provided from the controller 1120 and the second detection signal Charge_status provided from the comparator 1115 so that the output high voltage HV_out maintains the target voltage.
  • the feedback circuit 1113 converts the output high voltage HV_out into a feedback voltage Vfb and provides it to the voltage-frequency converter 1114 and the comparator 1115 .
  • the output high voltage HV_out is output as a high voltage of several thousand volts (eg, 3 kV). Accordingly, in the case of feedback without changing the level of the output high voltage HV_out, the internal circuit of the booster 1110 may malfunction or be destroyed due to voltage shock. Therefore, the level of the output high voltage HV_out by the feedback circuit 1113 should be normalized to a low voltage level that can be processed inside the booster 1110.
  • the output high voltage HV_out is converted into a relatively low feedback voltage Vfb by the feedback circuit 1113 .
  • the feedback voltage Vfb may be set to a level of 10V or less.
  • the voltage-frequency converter 1114 may output a pulse signal having a frequency corresponding to the level of the feedback voltage Vfb as the first detection signal VF_out.
  • setting the output oscillation frequency of the voltage-frequency converter (V/F Converter 114) is possible by adjusting a reference voltage or an internal RC time constant.
  • the voltage-frequency converter 1114 may be configured to output the first detection signal VF_out in the form of a pulse of 1.3 kHz with respect to the feedback voltage Vfb of 9 V.
  • the frequency of the output first detection signal VF_out may increase or decrease according to the increase or decrease of the feedback voltage Vfb.
  • the feedback voltage Vfb is converted into the first detection signal VF_out, which is a frequency signal, noise introduced into the output high voltage HV_out or the feedback voltage Vfb can be effectively removed.
  • an integrator is used in the voltage-frequency converter 1114, and noise included in the output high voltage (HV_out) or the feedback voltage (Vfb) can be substantially filtered by the integrator.
  • the voltage-to-frequency converter 1114 may be implemented as a circuit such as a voltage controlled oscillator (VCO).
  • the comparator 1115 compares the level of the feedback voltage Vfb with the set voltage V_set to generate the second detection signal Charge_status.
  • the set voltage V_set may be provided in a size corresponding to the target level of the output high voltage HV_out. That is, in order to set the output high voltage HV_out to output a target voltage (eg, 3 kV), the set voltage V_set may be set to 9V, which is voltage-divided by the feedback circuit 1113.
  • the comparator 1115 may transition the second detection signal Charge_status from the high level H to the low level L when the feedback voltage Vfb rises above the set voltage V_set.
  • the output high voltage HV_out may be double-monitored by the first detection signal VF_out and the second detection signal Charge_status output from the voltage-frequency converter 1114 and the comparator 1115, respectively.
  • the controller 1120 detects the level of the output high voltage HV_out with reference to the first detection signal VF_out and the second detection signal Charge_status, and generates a boost control signal Boost_CTRL for controlling the charge control circuit 1111.
  • booster 1110 of the present invention has been briefly described.
  • the configuration of the booster 1110 is only one embodiment of the present invention, and various changes or additions to the above configurations may be possible.
  • FIG. 3 is a circuit diagram showing the feedback circuit and the voltage-frequency converter of FIG. 2 as an example.
  • the feedback circuit 1113 divides the output high voltage HV_out to generate a feedback voltage Vfb.
  • the voltage-frequency converter 1114 generates the first detection signal VF_out having a variable frequency according to the level of the feedback voltage Vfb.
  • the feedback circuit 1113 includes a plurality of resistors R1, R2, R3, and R4 for voltage-dividing the output high voltage HV_out. Also, the feedback circuit 1113 may include a capacitor C1 for filtering noise included in the feedback voltage Vfb and a Zener diode D1 for stabilizing the feedback voltage Vfb.
  • the output high voltage HV_out formed at the output terminal (node N1) by the plurality of resistors R1, R2, R3, and R4 connected in series is voltage-divided to the feedback node N2 as the feedback voltage Vfb.
  • each of the resistors R1, R2, and R3 is 3.3M ⁇ and the resistor R4 is 30K ⁇
  • the resistance values of each of the resistors R1, R2, R3, and R4 may be set in various ways.
  • the capacitor C1 connected in parallel to the resistor R4 in which the feedback voltage Vfb is set can effectively filter noise included in the DC voltage feedback voltage Vfb.
  • Various types of noise may be introduced into the feedback voltage Vfb.
  • the boost circuit 1112 (see FIG. 2) may inherently generate noise due to the boost.
  • AC component noise may be included in the output high voltage HV_out or the feedback voltage Vfb due to defects in the elements.
  • a noise component introduced into the feedback voltage Vfb may be drained to ground by the capacitor C1.
  • the Zener diode D1 blocks the excessive rise of the feedback voltage Vfb, thereby stabilizing the feedback voltage Vfb.
  • the Zener diode D1 is doped with an appropriate breakdown voltage, it stabilizes the feedback voltage Vfb set in the reverse direction at both ends to a constant voltage. That is, the reverse current until the feedback voltage Vfb reaches the breakdown voltage of the Zener diode D1 is negligible, and when the feedback voltage Vfb reaches the breakdown voltage, the reverse current increases rapidly, but the reverse current is stable. voltage can be maintained. Therefore, a stable constant voltage corresponding to the breakdown voltage may be maintained at the feedback node N2 by the Zener diode D1.
  • the voltage-frequency converter 1114 generates a first detection signal VF_out corresponding to the magnitude of the feedback voltage Vfb transmitted through the variable resistor VR1 and the resistor R5.
  • the first detection signal VF_out may be a pulse signal having a variable frequency according to the magnitude of the feedback voltage Vfb.
  • the frequency of the first detection signal VF_out output from the voltage-frequency converter 1114 can be adjusted by adjusting the reference voltage set in the reference voltage input terminal RT or the internal RC time constant.
  • the voltage-frequency converter 1114 may be configured to output a first detection signal VF_out of 1.3 kHz for a feedback voltage Vfb of 9V. Noise introduced into the feedback voltage Vfb through the voltage-frequency converter 1114 can be effectively removed.
  • the voltage-frequency converter 1114 can be implemented through various IC devices other than the illustrated form.
  • FIG. 4 is a circuit diagram for explaining a schematic concept of the comparator of FIG. 2 . Referring to FIG. 4 , it is possible to detect whether the feedback voltage Vfb reaches the set voltage V_set by the comparator 1115a using an operational amplifier (OP-amp) according to an embodiment.
  • OP-amp operational amplifier
  • the comparator 1115a compares the level of the feedback voltage Vfb with the set voltage V_set to generate the second detection signal Charge_status. That is, the set voltage V_set is provided to the positive input terminal (+) of the comparator 1115a. Also, the feedback voltage Vfb is applied to the negative input terminal (-) of the comparator 1115a. When the feedback voltage Vfb is lower than the set voltage V_set, the second detection signal Charge_status is output at a high level (H). On the other hand, when the feedback voltage Vfb is equal to or higher than the set voltage V_set, the second detection signal Charge_status is output at a low level (L).
  • the set voltage V_set may be provided in a size corresponding to the target level of the output high voltage HV_out. That is, in order to set the output high voltage HV_out to output a target voltage (eg, 3 kV), the set voltage V_set may be set to 9V, which is a voltage divided by the feedback circuit 1113. In this case, when the feedback voltage Vfb is equal to or higher than 9V, the second detection signal Charge_status is transitioned from a high level (H) to a low level (L).
  • the level of the second detection signal Charge_status varies according to the levels of the feedback voltage Vfb and the set voltage V_set provided to the input terminal of the comparator 1115a.
  • the second detection signal Charge_status is output at a high level (H). Even if the feedback voltage (Vfb) increases, the second detection signal (Charge_status) is still maintained at the high level (H) in the period from T0 to T1 lower than the set voltage (V_set). This means that since the level of the output high voltage HV_out is lower than the target voltage, the boost circuit 1112 (see FIG. 2) needs to be charged more.
  • the feedback voltage (Vfb) reaches the set voltage (V_set), and maintains a state higher than the set voltage (V_set) until time T2.
  • the comparator 1115a will output a low level (L) second detection signal (Charge_status).
  • the low level (L) second detection signal (Charge_status) means that the charging of the boost circuit 1112 should be stopped because the level of the output high voltage (HV_out) reaches or is higher than the target voltage.
  • the feedback voltage (Vfb) decreases again to be less than the set voltage (V_set).
  • the second detection signal Charge_status transitions from the low level (L) to the high level (H).
  • the second detection signal Charge_status will maintain a high level (H) in the period T2 to T3 in which the feedback voltage Vfb is maintained lower than the set voltage V_set.
  • the boost circuit 1112 activates the charging operation by the second detection signal (Charge_status) of the high level (H).
  • the comparator 115b may include first and second comparators 1115-1 and 1115-2 and a digital variable resistor 1115-3.
  • the first comparator 1115-1 may output a second detection signal Charge_status by comparing the set voltage V_set provided by the digital variable resistor 1115-3 with the feedback voltage Vfb.
  • the set voltage V_set provided by the digital variable resistor 1115-3 is transmitted to the positive input terminal (+) of the first comparator 1115-1. That is, the set voltage V_set set up by the resistance value varied by the digital variable resistor 1115-3 and the distribution of the resistors R11 and R12 is the positive input terminal (+) of the first comparator 1115-1.
  • the feedback voltage Vfb is applied to the negative input terminal (-) of the first comparator 1115-1.
  • the feedback voltage Vfb may be provided by the feedback circuit 1113 described above.
  • the first comparator 1115-1 When the feedback voltage Vfb is lower than the set voltage V_set, the first comparator 1115-1 outputs a high level H second detection signal Charge_status. On the other hand, when the feedback voltage Vfb is equal to or higher than the set voltage V_set, the first comparator 1115-1 outputs a low level L second detection signal Charge_status.
  • the second comparator 1115-2 compares the fixed set voltage V_set_con and the feedback voltage Vfb to generate the second detection signal Charge_status. That is, the fixed set voltage V_set_con set up by the fixed resistors R17, R18, and R20 instead of the digital variable resistor 1115-3 is input to the positive input terminal (+) of the second comparator 1115-2. . Also, the feedback voltage Vfb is applied to the negative input terminal (-) of the second comparator 1115-2. When the feedback voltage Vfb is lower than the fixed set voltage V_set_con, the second detection signal Charge_status is output at a high level (H).
  • the second detection signal Charge_status is output at a low level (L).
  • the fixed set voltage V_set_con may be provided as the maximum value of the set voltage V_set that can be provided by the digital variable resistor 1115-3.
  • the sizes of the fixed resistors R17, R18, and R20 may be determined so that the fixed set voltage V_set_con is provided at 3 kV.
  • the digital variable resistor 1115-3 is a variable resistor that can be adjusted by a control unit such as a microcomputer.
  • the digital variable resistor 1115-3 can adjust the internal resistance of the data input terminal DIN to the variable resistance terminals A-W.
  • a variable set voltage (V_set) may be provided to the positive input terminal (+) of the first comparator 1115-1 through the setting of the digital variable resistor 1115-3.
  • the second detection signal (Charge_status) can be stably supplied through the first comparator 1115-1 and the second comparator 1115-2. That is, when the first comparator 1115-1 fails, the second comparator 1115-2 driven by the fixed set voltage V_set_con can stably supply the second detection signal Charge_status.
  • FIG. 7 is a circuit diagram showing the charging control circuit of FIG. 2 as an example.
  • the charging control circuit 1111 for controlling the charging operation of the boost circuit 1112 includes first and second MOSFET transistors Q1 and Q2. Each of the MOSFET transistors Q1 and Q2 is switched by a boost control signal (Boost_CTRL) provided from the controller 1120 and an inverted second detection signal (/Charge_status) provided from the comparator 1115, respectively.
  • Boost_CTRL boost control signal
  • /Charge_status inverted second detection signal
  • the first MOSFET transistor Q1 is switched by the boost control signal Boost_CTRL provided from the controller 1120 .
  • the boost control signal Boost_CTRL may be generated by the controller 1120 based on the first detection signal VF_out. That is, the controller 1120 composed of a control unit such as a microcomputer monitors the level of the output high voltage HV_out using the first detection signal VF_out obtained by converting the feedback voltage Vfb into a frequency signal. That is, the controller 1120 may monitor whether the output high voltage HV_out reaches a target voltage (eg, 3 kV) by monitoring the frequency of the first detection signal VF_out. That is, the controller 1120 may monitor whether the feedback voltage Vfb reaches the set voltage V_set from the first detection signal VF_out.
  • a target voltage eg, 3 kV
  • the controller 1120 If the monitored feedback voltage (Vfb) is lower than the level of the set voltage (V_set), the controller 1120 provides the boost control signal (Boost_CTRL) at a low level (L) to turn the first MOSFET transistor (Q1). Turn off. Then, the output node N3 of the charge control circuit 1111 is disconnected from the ground, and the charge control signal Enable of the high level H is output to a high level, so that the charge enable state can be obtained. That is, the charging operation of the boost circuit 1112 can be activated by the charging control signal (Enable) of the high level (H).
  • Boost_CTRL boost control signal
  • the controller 1120 when the monitored feedback voltage Vfb is equal to or higher than the set voltage V_set, the controller 1120 provides the boost control signal Boost_CTRL at a high level L to turn on the first MOSFET transistor Q1. (Turn-on). However, the charge control signal Enable is transitioned to the ground level only when both MOSFET transistors Q1 and Q2 are turned on.
  • the second MOSFET transistor Q2 is switched by the inverted second detection signal (/Charge_status) provided from the comparator 1115.
  • the second detection signal (Charge_status) is generated by comparing the set voltage (V_set) and the feedback voltage (Vfb) by the comparator 1115 . That is, the second detection signal (Charge_status) has a high level (H) when the feedback voltage (Vfb) is lower than the set voltage (V_set), and a low level when the feedback voltage (Vfb) is equal to or higher than the set voltage (V_set). will be forwarded to (L).
  • the inverted second detection signal (/Charge_status) is at a low level (L) when the feedback voltage (Vfb) is lower than the set voltage (V_set), and when the feedback voltage (Vfb) is equal to or higher than the set voltage (V_set) will be delivered at a high level (H).
  • the inverted second detection signal (/Charge_status) is transferred to a low level (L) to turn off the second MOSFET transistor (Q2) -off) Then, the output node N3 of the charge control circuit 1111 is disconnected from the ground, so that the high level H charge control signal can be enabled. That is, the charging operation of the boost circuit 1112 can be activated by the charging control signal (Enable) of the high level (H).
  • the inverted second detection signal (/Charge_status) is transferred to a high level (H) to turn on the second MOSFET transistor (Q2) (Turn-on).
  • the charge control signal Enable is transitioned to the ground level only when both MOSFET transistors Q1 and Q2 are turned on.
  • the state of the charge control signal (Enable) according to the level of the boost control signal (Boost_CTRL) and the inverted second detection signal (/Charge_status) can be summarized through Table 1 below.
  • the charge control signal (Enable) is output at a high level (H) when at least one of the boost control signal (Boost_CTRL) and the inverted second detection signal (/Charge_status) is a low level (L) do. Accordingly, when any one of the first detection signal VF_out and the second detection signal Charge_status is detected to be lower than the set voltage V_set, the charging control circuit 1111 activates the charging operation of the boost circuit 1112. something to do. As a result, it means that a stable output high voltage (HV_out) can be provided through double monitoring by the voltage-frequency converter 1114 and the comparator 1115 of the present invention.
  • the charge control circuit 1111 controls high level (H) charging when at least one of the boost control signal (Boost_CTRL) and the inverted second detection signal (/Charge_status) is low level (L). It is output as a signal (Enable).
  • H boost control signal
  • /Charge_status inverted second detection signal
  • both the boost control signal (Boost_CTRL) and the inverted second detection signal (/Charge_status) are input at a high level (H). That is, both the voltage-frequency converter 1114 and the comparator 1115 indicate that the output high voltage HV_out is being output at a target level. In this case, both the first and second MOSFET transistors Q1 and Q2 are turned on, and the charge control circuit 1111 outputs a low level L charge control signal Enable. .
  • the boost control signal Boost_CTRL is input at a high level (H), and the inverted second detection signal (/Charge_status) is input at a low level (L). That is, the voltage-frequency converter 1114 detects that the output high voltage HV_out is output at the target level, and the comparator 1115 detects that the output high voltage HV_out is lower than the target level. In this case, the first MOSFET transistors Q1 are turned on (Turn-On), and the second MOSFET transistor (Q2) is turned off (Turn-Off). Accordingly, the charge control circuit 1111 will output a high level (H) charge control signal (Enable).
  • the boost control signal (Boost_CTRL) is input at a low level (L), and the inverted second detection signal (/Charge_status) is input at a high level (H). That is, the voltage-frequency converter 1114 detects that the output high voltage HV_out is lower than the target level, and the comparator 1115 detects that the output high voltage HV_out is output at the target level. In this case, the first MOSFET transistor Q1 is turned off (Turn-Off), and the second MOSFET transistor (Q2) is turned on (Turn-On). Accordingly, the charge control circuit 1111 will output a high level (H) charge control signal (Enable).
  • both the boost control signal (Boost_CTRL) and the inverted second detection signal (/Charge_status) are input at a low level (L). That is, this is a case where both the voltage-frequency converter 1114 and the comparator 1115 detect a state in which the output high voltage HV_out is lower than the target level. In this case, both the first MOSFET transistor Q1 and the second MOSFET transistor Q2 are turned off. Accordingly, the charge control circuit 1111 will output a high level (H) charge control signal (Enable).
  • H high level
  • FIG. 9 is a flowchart briefly illustrating a control operation of the controller and the charging control circuit of FIG. 1 .
  • the controller 1120 and the charging control circuit 1111 may control the charging operation of the boost circuit 1112 using detection results of the voltage-frequency converter 1114 and the comparator 1115.
  • step S110 the level of the output high voltage (HV_out) of the irreversible electroporation system (1100, see Fig. 1) is fed back by the feedback circuit (1113, see Fig. 2). That is, the output high voltage (HV_out), which is a high voltage (1 to 3 kV) by voltage division of the feedback circuit 1113, is a feedback voltage (Vfb) of a low voltage level that can be managed by the voltage-frequency converter 1114 and the comparator 1115 is converted to
  • step S120 the controller 1120 generates a boost control signal Boost_CTRL based on the first detection signal VF_out input from the voltage-frequency converter 1114 . That is, when the output high voltage HV_out is lower than the target level and the first detection signal VF_out is output, the controller 1120 generates the boost control signal Boost_CTRL at a low level (L). On the other hand, when the output high voltage HV_out is equal to or higher than the target level and the first detection signal VF_out is output, the controller 1120 outputs the boost control signal Boost_CTRL at a high level (H).
  • the comparator 1115 generates an inverted second detection signal (/Charge_status) based on the second detection signal (Charge_status) output from the comparator 1115.
  • the inverted second detection signal (/Charge_status) may be generated through a means such as an inverter or logically generated by the controller 1120. That is, when the output high voltage (HV_out) is lower than the target level, the inverted second detection signal (/Charge_status) is generated with a low level (L). On the other hand, when the output high voltage HV_out is equal to or higher than the target level, the inverted second detection signal /Charge_status is output at a high level (H).
  • step S140 an operation branch occurs according to the level of the boost control signal (Boost_CTRL).
  • Boost_CTRL boost control signal
  • step S150 the charging operation of the boost circuit 1112 is activated.
  • step S160 the procedure moves to step S160.
  • step S160 an operation branch occurs according to the level of the inverted second detection signal (/Charge_status).
  • the inverted second detection signal (/Charge_status) is at a low level (YES direction)
  • the procedure moves to step S150.
  • the inverted second detection signal (/Charge_status) is at a high level (NO direction)
  • the procedure moves to step S170.
  • step S170 the charging operation of the boost circuit 1112 is deactivated.
  • the output high voltage (HV_out) of the irreversible electroporation system 1100 of the present invention can be double-monitored.
  • the level of the output high voltage HV_out can be stably managed and noise filtering can be performed efficiently.
  • the irreversible electroporation system 2100 may include a function generator 2110, a high voltage pulse generator 2120, a current detector 2130, a high voltage switch 2140, a controller 2150 and a probe 2160.
  • Function generator 2110 generates a pulse signal corresponding to the waveform of the output pulse (Pulse_out) to be provided by the irreversible electroporation system (2100).
  • the function generator 2110 may generate a pulse signal in the form of a square wave for use in treatment of a patient.
  • the function generator 2110 will generate a pulse signal having a constant amplitude according to setting information about the pulse width or duty cycle of the pulse signal to be output.
  • the function generator 2110 may generate not only a simple mono-polar pulse but also a bi-polar pulse signal.
  • the high voltage pulse generator 2120 may amplify a pulse signal provided from the function generator 2110 to a high voltage.
  • the high voltage pulse generator 2120 may receive a boosted high voltage (HV) through a booster (Booster, not shown) provided in the irreversible electroporation system 3100.
  • the high voltage pulse generator 2120 may output the high voltage pulse (HV_Pulse) by switching the high voltage (HV) according to the pulse signal or amplifying the pulse signal to a high voltage (HV) level.
  • the current detector 2130 detects a current value of the high voltage pulse HV_Pulse output from the high voltage pulse generator 2120 .
  • the current detector 2130 may measure a direct current (DC Current) in pulse units of the high voltage pulse (HV_Pulse).
  • the current of the high voltage pulse (HV_Pulse) may be measured by measuring the alternating current in a specific time unit.
  • the current detector 2130 may detect DC current for each of the pulse trains and provide the detected current I_sen value to the controller 2150 .
  • the high voltage switch 2140 may output or block the high voltage pulse HV_Pulse to the probe 2160 in response to the switch control signal SW of the controller 2150 .
  • the high voltage switch 2140 may be cut off in a situation where an overcurrent is supplied by the controller 2150.
  • the high voltage switch 2140 should be implemented using a high voltage element capable of stable switching even at a high voltage.
  • the controller 2150 receives the detection current I_sen provided from the current detector 2130 .
  • the controller 2150 may calculate an average current using the detected current I_sen value corresponding to each pulse.
  • the controller 2150 may exclude initial pulses in which the high voltage pulse HV_Pulse is generated from calculating the current average value. That is, the controller 2150 may use the detected current I_sen of each of the pulse trains after the current value of the high voltage pulse HV_Pulse is stabilized to calculate the average value. Also, after the current value of the high voltage pulse HV_Pulse is stabilized, the controller 2150 does not use a current value corresponding to a current peak such as an overshoot or undershoot of each pulse in calculating an average value.
  • the controller 2150 may variably apply the size of the limiting current to the high voltage pulse (HV_Pulse) according to the treatment mode. That is, the treatment mode may be differently applied depending on the tissue to which the irreversible electroporation is applied. For example, when the irreversible electroporation method for liver cancer is applied, the controller 2150 may determine a current level exceeding 30% of the average current as an overcurrent and may limit the current. On the other hand, when the irreversible electroporation method for pancreatic cancer is applied, the controller 2150 may determine and limit a current exceeding 20% of the average current value as an overcurrent. In addition, when the irreversible electroporation method for lung cancer is applied, the controller 2150 may determine and limit a current exceeding 10% of the average current value as an overcurrent.
  • HV_Pulse high voltage pulse
  • the controller 2150 may select various modes according to the characteristics of the area or tissue to which the procedure is applied. Therefore, it is possible to provide a more stable high voltage pulse (HV_Pulse) compared to an irreversible electroporation system that generally uses 50A as a limiting current.
  • the controller 2150 may be implemented using a MICOM or various control units.
  • the probe 2160 may serve as an electrode for applying the high voltage pulse (HV_Pulse) to the affected area or tissue or may be connected to the electrode.
  • Probe 2160 can be mounted, for example, on an endoscope to access tissue to be operated upon irreversibly electroporation.
  • the above irreversible electroporation system 2100 of the present invention can provide a more accurate current detection technique for the high voltage pulse (HV_Pulse). And the irreversible electroporation system 2100 of the present invention can set a variety of limiting current upon application of the high voltage pulse (HV_Pulse) can suppress the spark (Spark) generation in various conditions.
  • FIG. 11 is a timing diagram briefly illustrating a method of calculating an average current using a detected current in the controller of FIG. 10 .
  • the average current I_avg is calculated using the detected current I_sen after the pulse current is stabilized.
  • HV_Pulse generation of the high voltage pulse (HV_Pulse) starts at the time point T0.
  • the voltage pulse Voltage_Pulse
  • the current pulse Current_Pulse
  • level stabilization is slower than that of the voltage pulse (Voltage_Pulse). Accordingly, the first pulse P1 of the current pulse Current_Pulse does not reach the current I_std in the steady state. The increase of the current pulse of the high voltage pulse HV_Pulse will continue until the stabilized level of the pulse P4 is reached.
  • the fourth pulse P4 of the current pulse Current_Pulse is generated.
  • the level of the current pulse Current_Pulse reaches the stable level I_std, which is a steady state.
  • the current pulses P4, P5, P6, ... generated after the time point T3 are stabilized at a constant level I_std.
  • the controller 2150 When the controller 2150 calculates the average current using the size of the current pulse (Current_Pulse) detected by the current detector 2130, the controller 2150 will use only pulses after the pulse level is stabilized. For example, the detection current for the current pulses P1 to P3 before being stabilized will be excluded from the averaging operation. Further, current pulses after stabilization (eg, 10 pulses of P4 to P13) may be used in an averaging operation to obtain an average current.
  • FIG. 12 is a timing diagram showing a method of obtaining an average current in more detail according to the present invention.
  • a current value corresponding to an overshoot caused by application of a square wave to the current pulses P4 to P6 after level stabilization may be excluded from calculating the average current.
  • the detected current (I_sen) value of the flat section from which the effect of overshoot is excluded will be used for the averaging operation.
  • a current peak corresponding to the overshoot OS4 may occur.
  • the overshoots OS4, OS5, and OS5 included in each of these current pulses P4, P5, and P6 are due to the parasitic capacitance or distribution capacitance of the elements, and it is preferable to exclude them in order to substantially calculate the average current. Do. Therefore, when the overshoots OS_4, OS_5, and OS_6 included in each of the current pulses P4, P5, and P6 are excluded, the detected current I_sen of each flat section of the current pulses P4, P5, and P6 ) will be used for averaging.
  • the overshoots OS_4, OS_5, and OS_6 included in each of the current pulses P4, P5, and P6 from the average operation are filtered to detect the current ( A method of measuring I_sen) may be used.
  • FIG. 13 is a circuit diagram showing the high voltage switch shown in FIG. 10 as an example.
  • the high voltage switch 2140 may include a high voltage MOSFET (HV_MOSFET) that is turned on/off in response to a switch control signal (SW) provided from the controller 2150.
  • HV_MOSFET high voltage MOSFET
  • SW switch control signal
  • the controller 2150 sets the limit current I_lim based on the calculated average current I_avg.
  • the size of the limiting current I_lim may be selected to have a certain margin compared to the average current I_avg.
  • the controller 2150 uses the switch control signal SW to turn on the high voltage MOSFET HV_MOSFET when the detection current I_sen of the high voltage pulse HV_Pulse is equal to or smaller than the limit current I_lim. will print On the other hand, when the detection current I_sen of the high voltage pulse HV_Pulse is greater than the limit current I_lim, the switch control signal SW is output to turn off the high voltage MOSFET HV_MOSFET.
  • the high voltage pulse (HV_MOSFET) is output to the probe 2160 as an output pulse (Pulse_out).
  • HV_MOSFET high voltage MOSFET
  • the present invention is not limited thereto.
  • Various high voltage switching elements may be provided as switching elements constituting the high voltage switch 2140 .
  • FIG. 14 is a timing diagram exemplarily showing a method of blocking overcurrent performed by the controller of the present invention. Referring to FIG. 14 , a method for limiting overcurrent appearing in current pulses Pk, Pk+1, ... after being stabilized is illustrated. Here, it is assumed that the limit current I_lim is 20% higher than the average current I_avg.
  • the current level of the current pulse Pk generated at the time point Tk (k is a natural number equal to or greater than 4) is lower than the average current I_avg. Accordingly, the controller 2150 will generate a switch control signal SW to turn on the high voltage switch 2140.
  • the current level of the current pulse Pk+1 generated at the time point Tk+1 is higher than the average current I_avg and higher than the limit current I_lim. Accordingly, the controller 2150 determines that the current pulse Pk+1 is overcurrent and generates a switch control signal SW for turning off the high voltage switch 2140.
  • the current pulse (Pk+2) generated at the time of Tk+2 includes the current peak caused by the overshoot (OS_k+2).
  • OS_k+2 the overshoot
  • the current level of the current pulse Pk+2 including the overshoot OS_k+2 will be detected to be higher than the average current I_avg.
  • the detection current I_sen at the current pulse Pk+2 will be detected as being lower than the limit current I_lim.
  • the controller 2150 will not determine the current pulse Pk+2 as overcurrent. Accordingly, the controller 2150 will generate a switch control signal SW for turning on the high voltage switch 2140 at the time point Tk+2.
  • a current peak due to overshoot (OS_k+3) is included in the current pulse (Pk+3) generated at the time of Tk+3.
  • the overcurrent caused by the current peak must also be blocked.
  • the current level of the flat section of the current pulse Pk+3 is lower than the limit current I_lim
  • the current level of the overshoot OS_k+3 will be detected higher than the limit current I_lim. Accordingly, the detection current I_sen of the current pulse Pk+3 will be detected as being lower than the limit current I_lim.
  • the controller 2150 determines the current pulse Pk+3 as overcurrent. Accordingly, the controller 2150 will generate a switch control signal (SW) for turning off the high voltage switch 2140 at the time point Tk+3.
  • SW switch control signal
  • the current level of the current pulse Pk+3 generated at the time point Tk+4 will be detected similarly to the average current I_avg. Accordingly, the controller 2150 determines the current pulse Pk+4 as a normal current and generates a switch control signal SW for turning on the high voltage switch 2140.
  • FIG. 15 is a timing diagram exemplarily showing a method of blocking overcurrent for each mode according to the present invention.
  • a switch control signal provided to the high voltage switch 2140 for blocking overcurrent in a plurality of treatment modes (mode1, mode2, mode3) having different levels of limited current (I_lim1 ⁇ I_lim2 ⁇ I_lim3)
  • the waveform of (SW) is shown.
  • the first limit current I_lim1 is a limit current in the first mode mode1 and is 10% higher than the average current I_avg.
  • the second limit current I_lim2 is the limit current in the second mode (mode2) and is 20% higher than the average current I_avg
  • the third limit current I_lim3 is the limit current in the third mode (mode3). As the limiting current, it is assumed that it is 30% higher than the average current (I_avg).
  • the current level of the current pulse Pk generated at the time point Tk (k is a natural number equal to or greater than 4) is lower than the average current I_avg.
  • the detection current I_sen sensed from the current pulse Pk is lower than the first to third limit currents I_lim1, I_lim2, and I_lim3, respectively. Accordingly, at the time Tk, regardless of the procedure mode, the controller 2150 will generate a switch control signal SW for turning on the high voltage switch 2140.
  • the current level of the current pulse Pk+1 generated at the time Tk+1 is detected to be higher than the second limit current I_lim2 and lower than the third limit current I_lim3. Therefore, in the treatment modes of the first mode (mode1) and the second mode (mode2), the current pulse (Pk+1) will be determined as overcurrent. In this case, the controller 2150 will generate a switch control signal SW to turn off the high voltage switch 2140 . On the other hand, in the treatment mode of the third mode (mode3), the current pulse (Pk+1) will be determined as a normal current. Accordingly, the controller 2150 will maintain the high voltage switch 2140 in a turned-on state.
  • a current peak (peak1) is included in the current pulse (Pk+2) generated at the time of Tk+2.
  • the influence of current peaks such as overshoot is excluded, but the overcurrent caused by the current peak must also be blocked in the operation to block the overcurrent.
  • the detection current I_sen of the current pulse Pk+2 including the current peak peak1 is sensed higher than the first limit current I_lim1 and lower than the second limit current I_lim2. Therefore, in the treatment mode of the first mode (mode1), the current pulse (Pk+2) will be determined as overcurrent.
  • the controller 2150 will generate a switch control signal SW to turn off the high voltage switch 2140 .
  • the current pulse (Pk+2) will be determined as a normal current. Accordingly, the controller 2150 will generate the high voltage switch 2140 in a turn-on state.
  • the current peak (peak2) may also be included in the current pulse (Pk+3) generated at the time point Tk+3. Due to the current peak2, the detection current I_sen of the current pulse Pk+3 is sensed higher than the first to third limit currents I_lim1, I_lim2, and I_lim3. Therefore, in all treatment modes of the first to third modes (mode1, mode2, and mode3), the current pulse (Pk+3) will be determined as overcurrent. In this case, the controller 2150 will generate a switch control signal SW to turn off the high voltage switch 2140 regardless of the procedure mode.
  • the current level of the current pulse Pk+4 generated at the time point Tk+4 is sensed higher than the average current I_avg, but lower than the first to third limit currents I_lim1 to I_lim3. Accordingly, at the time of Tk+4, regardless of the procedure mode, the controller 2150 will generate a switch control signal (SW) for turning on the high voltage switch 2140.
  • SW switch control signal
  • the overcurrent blocking method to which different limit currents (I_lim1, I_lim2, and I_lim3) are applied for each treatment mode has been briefly described.
  • the overcurrent blocking method of the irreversible electroporation system 2100 of the present invention is limited to the three treatment modes (mode1 to mode3), but the present invention is not limited to the disclosure herein. It will be well understood that applicable limit currents may be set even in two treatment modes or four or more treatment modes, and thus overcurrent blocking may be executed.
  • FIG. 16 is a timing diagram illustrating a method of blocking overcurrent according to another embodiment of the present invention.
  • the overcurrent limiting method of the present invention can be applied even to a high voltage pulse of a bipolar waveform.
  • average currents I_avg+ and I_avg- and limit currents I_lim+ and I_lim- for each polarity may be applied to the bipolar current pulse Current_Pulse.
  • the limiting currents I_lim+ and I_lim- may be divided into a plurality of levels.
  • the method of calculating the average current (I_avg+, I_avg-) may be applied for each polarity in the same way as in the previously described current pulse of a monopolar waveform.
  • a positive (+) polarity current pulse Pk is generated.
  • the level of the current I_sen detected by the current pulse Pk is higher than the average current I_avg+ but lower than the limit current I_lim+. Accordingly, at the time point Tk, the controller 2150 will generate the switch control signal SW to turn on the high voltage switch 2140.
  • a negative (-) polarity current pulse (Pk+1) generated at the time Tk+1 is generated.
  • the current level of the current pulse Pk+1 is lower than the average current I_avg- (absolute value is high), but higher than the limit current I_lim- (absolute value is low). Therefore, since the current magnitude of the current pulse Pk+1 is smaller than the limit current I_lim-, the controller 2150 maintains the turn-on state of the high voltage switch 2140 at the time Tk+1.
  • a switch control signal (SW) will be generated.
  • a positive (+) polarity current pulse (Pk+2) is generated again.
  • the level of the current I_sen detected by the current pulse Pk+2 will be sensed higher than the average current I_avg+ and the limit current I_lim+. Accordingly, at the time of Tk+2, the controller 2150 will generate the switch control signal SW to turn off the high voltage switch 2140.
  • a negative (-) polarity current pulse (Pk+3) generated at the time of Tk+3 is generated.
  • the detection current I_sen at the current pulse Pk+3 will be sensed lower than the limit current I_lim- (the absolute value is higher).
  • the controller 2150 will determine the current pulse (Pk+3) as overcurrent. Accordingly, at the time of Tk+3, the controller 2150 will generate the switch control signal SW to turn off the high voltage switch 2140.
  • a current pulse (Pk+4) of positive (+) polarity generated at the time of Tk+4 is generated.
  • a current peak is observed at the current pulse (Pk+4).
  • the detection current I_sen at the current peak generated from the current pulse Pk+4 is higher than the average current I_avg+, but is sensed lower than the limit current I_lim+. Accordingly, the controller 2150 will generate a switch control signal SW to turn on the high voltage switch 2140.
  • a negative (-) polarity current pulse (Pk+4) generated at the time of Tk+5 is generated.
  • a current peak is also observed at the current pulse (Pk+5).
  • the detection current I_sen at the current peak generated from the negative polarity current pulse Pk+5 will be sensed lower than the average current I_avg- (absolute value is high) and lower than the limit current I_lim-.
  • the controller 2150 will determine the current pulse (Pk+5) as overcurrent. Accordingly, at the time of Tk+5, the controller 2150 will generate the switch control signal SW to turn off the high voltage switch 2140.
  • FIG 17 is a flow chart briefly showing the overcurrent blocking method of the irreversible electroporation system of the present invention.
  • the irreversible electroporation system 3100 of the present invention can calculate an accurate average current value, based on the average current value can provide multiple levels of overcurrent blocking function.
  • step S210 when the irreversible electroporation system (1100, see FIG. 10) is booted, the high voltage pulse generator (2120, see FIG. 10) calculates the average current (I_avg) of the high voltage pulse (HV_Pulse) and sets the limit current. It begins. When power is applied, the various components of the irreversible electroporation system 2100 are activated.
  • the high voltage pulse HV_Pulse is generated by the high voltage pulse generator 2120.
  • the pulse signal provided from the function generator 2110 may be amplified to a high voltage level by the high voltage pulse generator 2120.
  • a pulse signal of 3.3V amplitude generated by the function generator 2110 may be amplified into a high voltage pulse (HV_Pulse) of thousands of volts (eg, 3 kV) by the high voltage pulse generator 2120.
  • step S230 the current size of the high voltage pulse (HV_Pulse) is detected and the average current (I_avg) is calculated.
  • the average current I_avg will use the detection current I_sen sensed after the current value of the high voltage pulse HV_Pulse is stabilized.
  • the detection current I_sen sensed from several pulses P1 to P3 initially generated of the high voltage pulse HV_Pulse may be excluded from calculating the average current I_avg. That is, the controller 2150 may calculate the average current I_avg using a plurality of high voltage pulses HV_Pulse generated after the current value is stabilized.
  • the limit current I_lim is selected based on the calculated average current I_avg. For example, if three treatment modes (mode1, mode2, and mode3) are provided, one of the three limiting currents (I_lim1, I_lim2, and I_lim3) corresponding to the selected treatment mode may be selected.
  • the first limit current I_lim1 is a limit current in the first mode mode1 and may be provided with a value 10% higher than the average current I_avg.
  • the second limit current I_lim2 is the limit current in the second mode (mode2) and has a value 20% higher than the average current I_avg
  • the third limit current I_lim3 is the limit current in the third mode (mode3). As a current, it can be provided with a value 30% higher than the average current (I_avg).
  • an output pulse Pulse_out may be output through the high voltage switch 2140 under the selected limit current I_lim condition.
  • Current peaks or sudden overcurrents due to various factors in the electrodes to which the output pulses (Pulse_out) are provided can be suppressed to the selected limit current (I_lim) level. Accordingly, overcurrent blocking characteristics optimized for the selected procedure characteristics may be provided.
  • the irreversible electroporation system 2100 of the present invention is capable of accurately calculating the average current (I_avg) for the generated high voltage pulse (HV_Pulse).
  • an overcurrent blocking function optimized for applied treatment characteristics based on the accurate average current I_avg may be provided.
  • the irreversible electroporation system 3100 may include a function generator 3110 , a pulse shaper 3130 , and an electrode 3150 .
  • Function generator 3110 generates a basic pulse signal for forming the waveform of the high-frequency pulse output from the non-reversible electroporation system 3100.
  • the function generator 3110 may generate a pulse signal having a waveform corresponding to the selected mode.
  • the input mode may be classified according to the ratio (pulse width : pulse interval : pulse width) of output high frequency pulses. That is, the mode represents a ratio of a positive pulse width, a pulse interval, and a negative pulse width in a bipolar pulse. That is, the mode may have a concept similar to a duty cycle indicating a ratio of a pulse width to a pulse interval in a unipolar pulse.
  • the function generator 2110 If the mode is the first mode (Mode_1) indicating '1:1:1', the function generator 2110 outputs a positive pulse width, a pulse interval, and a bipolar pulse having the same ratio of negative pulse widths. will generate a signal. At this time, the bipolar pulse signal output from the function generator 2110 may be generated in the form of a square wave.
  • the pulse generator 3130 converts the bipolar pulse signal provided from the function generator 3110 into the high frequency pulse signal HF_Pulse according to the selected mode.
  • the high frequency pulse signal HF_Pulse output from the pulse generator 3130 is a positive pulse including a positive pulse period, a pulse interval, and a negative pulse period.
  • the voltage pulse has an exponentially decreasing form according to a predefined time constant ( ⁇ ) from the positive voltage peak. Also, 0V (or ground level) is maintained in the pulse interval section.
  • the high frequency pulse signal HF_Pulse is provided in an exponentially increasing form at a negative voltage peak in a negative pulse period. Specific forms of the high frequency pulse signal HF_Pulse will be described in detail in a timing diagram to be described later.
  • the electrode 3150 is provided as a means for applying a high frequency pulse (HF_Pulse) to the affected area or tissue.
  • the electrodes 3150 may be mounted on, for example, an endoscope or other surgical equipment and applied to tissue to be operated according to irreversible electroporation. Electroporation and electrochemical reactions are induced in the affected area or tissue by the high voltage pulse (HV_Pulse) of the present invention, so that tissues such as cancer cells can be cauterized more efficiently.
  • HV_Pulse high voltage pulse
  • the above irreversible electroporation system 3100 of the present invention can induce an electrochemical reaction with electroporation by providing a high-frequency pulse (HF_Pulse) of bipolarity.
  • HF_Pulse high-frequency pulse
  • a shadow region of electroporation may exist due to non-uniformity of an electric field that inevitably occurs depending on the shape or configuration of the electrode 3150 .
  • Tissue cauterization may be further performed through a subsequent electrochemical reaction for the shaded area. Therefore, during the procedure through the irreversible electroporation system 3100 of the present invention, it is possible to provide an effect of cauterizing cancer cells that cannot be achieved only by the electroporation method.
  • HF_Pulse high-frequency pulses
  • FIG. 19 in order to describe the characteristics of the high frequency pulse (HF_Pulse), a high frequency pulse (HF_Pulse) having a '1:1:1' ratio will be described as an example.
  • the positive pulse peak V of the high frequency pulse HF_Pulse is provided.
  • the high frequency pulse HF_Pulse has a form of exponentially decreasing from a positive peak to a ground level.
  • a period exponentially decreasing from a positive pulse peak or a period exponentially increasing from a negative pulse peak to 0V will be referred to as a pulse decay period.
  • the voltage pulse will have a decay period until the time point T1.
  • the pulse decay period may be longer or shorter depending on the setting of the time constant ( ⁇ ).
  • the application of the positive pulse ends and corresponds to the pulse interval maintaining the ground level.
  • the voltage of the high frequency pulse (HF_Pulse) will be recovered to the ground level (or 0V).
  • a negative pulse peak (V magnitude) of the high frequency pulse (HF_Pulse) is provided. Then, the high frequency pulse HF_Pulse follows a pulse decay period that increases exponentially from the negative pulse peak to the ground level. After the negative pulse is applied, the voltage pulse will have a pulse decay period until time T4.
  • the high frequency pulse (HF_Pulse) of the pulse mode having a '1:1:1' ratio has been described as an example.
  • electroporation action occurs as in conventional electroporation.
  • an electrochemical reaction is induced, and tissue cauterization to which the electroporation effect has not been achieved may be performed.
  • FIG. 20 is a flowchart briefly showing a method of applying a high frequency pulse (HF_Pulse) in the irreversible electroporation system of the present invention.
  • HF_Pulse high frequency pulse
  • the irreversible electroporation system 3100 of the present invention can generate the waveform of the optimal high-frequency pulse (HF_Pulse) according to the pulse mode, the electrochemical reaction in the area that the electroporation does not reach can induce a high therapeutic effect.
  • step S310 when booted for a procedure using the irreversible electroporation system (3100, see FIG. 18), selection of the pulse mode by the user is made. For example, when a first mode (Mode_1) is selected from among a plurality of modes, the function generator 3110 displays '1:1:1' in which the ratio of the positive pulse width to the pulse interval and the negative pulse width is the same. It will generate a pulse signal in the form of a square wave of a waveform.
  • the pulse mode will be described in the drawings to be described later, but it will be well understood that pulse modes corresponding to various ratios may be implemented.
  • the pulse signal in the form of a square wave may form a high frequency pulse (HF_Pulse) having a decay characteristic to which a time constant ( ⁇ ) of a specific size is applied by the pulse generator 3130.
  • a high-frequency pulse (HF_Pulse) in which a positive pulse and a negative pulse decrease or increase exponentially may be formed by using high voltage switching or amplification of a pulse signal in the form of a square wave.
  • it may be performed by adjusting the time constant ⁇ at the output terminal of the high frequency pulse HF_Pulse.
  • step S330 an electroporation action by the pulse peak provided to the electrode occurs.
  • a high voltage pulse peak is applied between the electrodes, a relatively large electric field will be formed. Electroporation occurs in the cell membrane by this electric field. That is, a strong electric field will be formed between an anode and a cathode located on both sides of a tissue cell such as a cancer cell. Additionally, it will be appreciated that near infrared rays may be irradiated using an optical fiber. In this case, hyperpolarization and depolarization are induced in the cell membrane of the tumor tissue, respectively, and as a result, irreversible pores are formed in the cell membrane to induce cell death.
  • a pulse decay section follows step S330 continuously.
  • the magnitude of the electric field formed between the anode and cathode of the electrode has a characteristic proportional to the voltage. Therefore, in the pulse decay period, the intensity of the electric field also decreases exponentially equal to the intensity of the voltage. This exponential decrease in electric field intensity may induce different electrochemical reactions in the vicinity of the anode and cathode of the electrode. Hyperpolarization or depolarization by a strong electric field does not occur uniformly in all regions between electrodes.
  • the electrochemical reaction induced by the pulse decay can be relatively uniformly induced between the electrodes. Therefore, when the pulse application method of the present invention is applied, even cancer cells that survive electroporation can be eliminated by an electrochemical reaction.
  • step S350 it is determined whether the currently applied pulse corresponds to the final pulse of the previously planned target pulse. For example, the number of pulses provided in a specific mode is predetermined, and when the corresponding number of pulses is applied, the procedure may be completed. If the pulse applied in steps S330 and S340 corresponds to the last pulse of the target pulse, all high frequency pulse (HF_Pulse) application operations may be terminated. On the other hand, if the pulse applied in steps S330 and S340 is not the last pulse of the target pulse, the procedure moves to step S330 and an additional pulse (pulse of opposite polarity) is applied.
  • HF_Pulse high frequency pulse
  • FIG. 21 are timing diagrams showing waveforms of high frequency pulses (HF_Pulse) in various modes according to an embodiment of the present invention.
  • HF_Pulse high frequency pulses
  • the relative ratio of pulse width or pulse interval can be freely adjusted according to the mode. Adjustment of such a pulse width or pulse interval can be a means for adjusting the characteristics of an electrochemical reaction.
  • the waveform of the high frequency pulse (HF_Pulse) of the first mode (Mode_1) corresponds to '1:1:1' in the ratio of pulse width, pulse interval, and pulse width.
  • the waveform of the high frequency pulse (HF_Pulse) of the second mode (Mode_2) corresponds to '1:2:1' in the ratio of pulse width, pulse interval, and pulse width.
  • HF_Pulse high frequency pulse
  • the pulse decay provided from the time point T3 to the time T4 has the same length as the pulse decay from the time T0 to the time T1 but the opposite polarity. Accordingly, the high frequency pulse (HF_Pulse) in the second mode (Mode_2) may be provided at a ratio of '1:2:1' between the pulse width, the pulse interval, and the pulse width.
  • the waveform of the high frequency pulse (HF_Pulse) of the third mode (Mode_3) corresponds to '1:2:2' of the ratio of pulse width, pulse interval, and pulse width.
  • a positive pulse peak is applied at time T0
  • pulse decay continues until time T1.
  • a pulse interval twice as long as the pulse decay period is provided.
  • a negative pulse peak is applied at a time point T3
  • the pulse decay provided from time T3 to time T5 may be provided with a polarity opposite to that of the pulse decay from time T0 to time T1 and twice as long. Accordingly, the high frequency pulse (HF_Pulse) in the third mode (Mode_3) may be provided at a ratio of '1:2:2' between the pulse width, the pulse interval, and the pulse width.
  • the waveform of the high frequency pulse (HF_Pulse) of the fourth mode (Mode_4) corresponds to '2:1:1' in the ratio of pulse width, pulse interval, and pulse width.
  • a pulse interval with a length 1/2 times the length of the pulse decay period is provided.
  • the pulse decay provided from the time T3 to the time T4 may be provided with a polarity opposite to that of the pulse decay from the time T0 to the time T2 and a half-length.
  • the high frequency pulse (HF_Pulse) in the fourth mode (Mode_4) may be provided at a ratio of '2:1:1' between the pulse width, the pulse interval, and the pulse width.
  • the waveform of the high frequency pulse (HF_Pulse) of the fifth mode (Mode_4) corresponds to '2:2:1' in the ratio of pulse width, pulse interval, and pulse width.
  • a pulse interval having the same length as the pulse decay period is provided from time T2 to time T4.
  • the pulse decay provided from the time T4 to the time T5 may be provided with a polarity opposite to that of the pulse decay from the time T0 to the time T2 and a half-length.
  • the high frequency pulse (HF_Pulse) in the fifth mode (Mode_5) may be provided at a ratio of '2:2:1' between the pulse width, the pulse interval, and the pulse width.
  • the magnitude (V) of the pulse peak may be set to 0.5 to 10,000 kV / cm, the pulse width to 0.5 ⁇ s to 20 ⁇ s, the pulse interval to 1 ⁇ s to 100 ⁇ s, and the pulse decay period to 1 ⁇ s to 40 ⁇ s. .
  • the speed or strength of the electrochemical reaction can be adjusted to various levels.
  • the illustrated modes of the high frequency pulse (HF_Pulse) are only examples and various modes of various ratios may be added.
  • electroporation and an electrochemical reaction may be induced by a high frequency pulse (HF_Pulse) provided as a pulse peak 3210 and a pulse decay 3230 .
  • HF_Pulse high frequency pulse
  • an electroporation action S1 occurs due to the pulse peak provided to the electrode.
  • S1 an electroporation action
  • E the electric field formed by the pulse peak 3210
  • ⁇ V potential difference
  • Equation 1 electroporation occurs in the cell membrane of a cell such as a cancer cell by an electric field (E). That is, a strong electric field E will be formed between the anode 3151 and the cathode 3153 located on both sides of tissue cells such as cancer cells. Additionally, it will be well understood that cells may be irradiated with near-infrared rays using an optical fiber. In this case, hyperpolarization and depolarization are induced in the tissue cell membrane of the tumor, respectively.
  • E electric field
  • Hyperpolarization is induced in a portion of the cell membrane adjacent to the anode 3151, and depolarization is induced in a portion of the cell membrane adjacent to the cathode 3153. That is, when hyperpolarized, K+ ions in the cell may be released to the outside of the tumor. As a result, irreversible pores may be formed in the cell membrane to induce apoptosis.
  • an electrochemical reaction occurs by an electric field provided to an electrode that decreases exponentially.
  • S2 electrochemical reaction
  • water is separated into oxygen and hydrogen ions near the anode 151, and water is separated into hydrogen and hydroxide ions near the cathode 3153.
  • Cell death can be accelerated by this electrochemical action.
  • Characteristics of the electrochemical action can be performed by adjusting the length of the pulse decay period or the size of the pulse peak by mode selection.

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Abstract

Un système d'électroporation irréversible destiné à générer une haute tension de sortie selon un mode de réalisation de la présente invention comprend : un circuit amplificateur destiné à générer la haute tension de sortie par l'intermédiaire d'une opération de charge pour une tension d'entrée; un circuit de rétroaction pour convertir, en une tension de rétroaction, la haute tension de sortie provenant du circuit amplificateur; un convertisseur tension-fréquence destiné à générer un premier signal de détection présentant une fréquence qui varie en fonction d'un niveau de la tension de rétroaction; et un dispositif de commande destiné à générer un signal de commande d'amplification pour commander l'opération de charge du circuit amplificateur en référence au premier signal de détection. Le système d'électroporation irréversible selon un mode de réalisation de la présente invention est en mesure de détecter une haute tension de sortie exempte de bruit par rétroaction de la haute tension de sortie dans un schéma de conversion tension-fréquence. Par conséquent, un système d'électroporation irréversible en mesure d'assurer une alimentation stable d'une haute tension de sortie peut être mis en oeuvre.
PCT/KR2022/009141 2021-06-29 2022-06-27 Système d'électroporation irréversible et procédé d'application d'impulsions correspondant Ceased WO2023277488A1 (fr)

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KR10-2021-0084870 2021-06-29
KR10-2021-0084859 2021-06-29
KR1020210084859A KR102343921B1 (ko) 2021-06-29 2021-06-29 과전류를 차단하는 비가역적 전기천공 시스템
KR1020210084870A KR102346167B1 (ko) 2021-06-29 2021-06-29 전기화학적 작용을 유도하는 고주파 비가역적 전기천공 시스템의 펄스 인가 방법
KR1020210084844A KR102326448B1 (ko) 2021-06-29 2021-06-29 안정적으로 출력 고전압을 모니터링하는 비가역적 전기천공 시스템
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CN116158838A (zh) * 2023-03-16 2023-05-26 上海圣达济医疗科技有限公司 一种不可逆电穿孔脉冲发生系统
CN118285901A (zh) * 2024-04-25 2024-07-05 天津市鹰泰利安康医疗科技有限责任公司 一种高频双极性不可恢复电穿孔电路
US12076071B2 (en) 2020-08-14 2024-09-03 Kardium Inc. Systems and methods for treating tissue with pulsed field ablation

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12076071B2 (en) 2020-08-14 2024-09-03 Kardium Inc. Systems and methods for treating tissue with pulsed field ablation
CN116158838A (zh) * 2023-03-16 2023-05-26 上海圣达济医疗科技有限公司 一种不可逆电穿孔脉冲发生系统
CN118285901A (zh) * 2024-04-25 2024-07-05 天津市鹰泰利安康医疗科技有限责任公司 一种高频双极性不可恢复电穿孔电路

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