WO2022258034A1 - Appareil de génération d'impulsions et procédé de commande d'impulsions - Google Patents

Appareil de génération d'impulsions et procédé de commande d'impulsions Download PDF

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Publication number
WO2022258034A1
WO2022258034A1 PCT/CN2022/098010 CN2022098010W WO2022258034A1 WO 2022258034 A1 WO2022258034 A1 WO 2022258034A1 CN 2022098010 W CN2022098010 W CN 2022098010W WO 2022258034 A1 WO2022258034 A1 WO 2022258034A1
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pulse
output
frequency
pulses
power supply
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PCT/CN2022/098010
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English (en)
Chinese (zh)
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洪光
陈劲松
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成都飞云科技有限公司
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Publication of WO2022258034A1 publication Critical patent/WO2022258034A1/fr

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    • H—ELECTRICITY
    • H03—ELECTRONIC CIRCUITRY
    • H03K—PULSE TECHNIQUE
    • H03K3/00—Circuits for generating electric pulses; Monostable, bistable or multistable circuits
    • H03K3/64—Generators producing trains of pulses, i.e. finite sequences of pulses

Definitions

  • the invention relates to the field of pulse technology, in particular to a pulse generating device and a pulse control method.
  • radio frequency technology can generate a fixed frequency sine wave.
  • the generated radiofrequency energy acts on the lesion to be treated through the radiofrequency catheter or radiofrequency electrode, so that it can achieve the effect of blocking or conditioning, and then achieve the therapeutic effect.
  • the radio frequency technology uses a sine wave signal of a specific frequency, although it outputs higher energy, because of its fixed frequency, the system connected to it can remove the interference of the radio frequency signal to other signals through band-stop filtering.
  • radiofrequency ablation technology which belongs to thermal ablation technology, may also ablate and destroy non-target cells due to lack of cell selectivity.
  • High-voltage pulse technology As a non-thermal ablation technology, has gradually attracted the attention of clinical application.
  • High-voltage pulse technology generates a high-voltage pulsed electric field with a pulse width of milliseconds, microseconds or even nanoseconds to release extremely high energy in a short period of time, which can make cell membranes and even intracellular organelles such as endoplasmic reticulum, mitochondria, Nuclei, etc. will produce a large number of irreversible micropores, which will cause the apoptosis of diseased cells, so as to achieve the expected therapeutic purpose.
  • the use of high-voltage pulse technology can selectively treat cardiomyocytes without affecting other non-target cell tissues, and it also has thorough full-thickness ablation, Accurate, fast, and coronary artery protection, therefore, high-voltage pulsed radiofrequency technology is expected to become an ideal means of cardiac ablation.
  • the existing high-voltage pulse technology uses a regulated power supply to charge the capacitor, and then controls the switch to discharge to generate pulses. Due to the limited power of the power supply and the capacity of the capacitor, when discharging a large load, the amplitude of the pulse tail will drop greatly, and it is difficult to achieve a relatively high voltage. Wide pulse width; in addition, for clinical functions that require multiple outputs and high-frequency modulation, the existing high-voltage pulse technology is also difficult to achieve.
  • the technical problem to be solved by the present invention is to propose a pulse generating device and a pulse control method to solve the problems that it is difficult to achieve a wider pulse width and radio frequency modulation during high-voltage pulse therapy, thereby improving the effectiveness of high-voltage pulse therapy .
  • One aspect of the present invention provides a pulse generating device, including a DC power supply, a charging capacitor of an energy storage device, a pulse generator, a pulse synthesizer and a demultiplexer;
  • the pulse generator is a high-frequency pulse generator, which is used to generate high-frequency narrow pulses during pulse output;
  • the pulse synthesizer is used to synthesize the high-frequency narrow pulse into a unipolar radio frequency modulated pulse or a unipolar wide pulse according to whether radio frequency modulation is required;
  • the demultiplexer is used for distributing the synthesized pulses to corresponding treatment electrodes and controlling their polarity.
  • the high-frequency narrow pulse is a bipolar high-frequency narrow pulse.
  • the pulse synthesizer can combine the bipolar high-frequency narrow pulse After rectification, it is further integrated and filtered to synthesize unipolar pulses of any required time width, and only bipolar high-frequency narrow pulses can be rectified and output as radio frequency modulation signals.
  • the DC power supply can be a high instantaneous power DC power supply, and the energy storage can include a charging capacitor and a fast discharge circuit; during non-pulse output, the DC power supply can be Charge the charging capacitor with low power.
  • the DC power supply charges the charging capacitor with high instantaneous power, and discharges the excess capacitor power through the fast discharge circuit, thereby generating any voltage amplitude required by the pulse.
  • the half-bridge inside the demultiplexer can be connected to the input pulse signal, and the pulse signal can be distributed to the corresponding treatment electrodes through the half-bridge, and its polarity can be controlled.
  • the half-bridge-type demultiplexer of the present invention has simpler structure and faster response speed.
  • the pulse generating device of the present invention can be applied to ablation therapy, such as tachyarrhythmia therapy, tissue ablation, tumor therapy, etc., and can also be applied to non-ablation therapy, such as nerve stimulation and defibrillation.
  • ablation therapy such as tachyarrhythmia therapy, tissue ablation, tumor therapy, etc.
  • non-ablation therapy such as nerve stimulation and defibrillation.
  • the treatment electrode is an ablation electrode
  • the frequency range of the bipolar high-frequency narrow pulse is generally 10KHz-10MHz, preferably 50KHz-500KHz.
  • the frequency range of the high-frequency narrow pulse in the present invention is usually 10KHz-10MHz, preferably 50KHz-500KHz.
  • another aspect of the present invention also provides a pulse control method.
  • the pulse output period firstly generate a bipolar high-frequency narrow pulse; then perform corresponding pulse synthesis processing according to whether radio frequency modulation is required, Including: when radio frequency modulation is not required, bipolar high frequency narrow pulse rectification and integral filtering are synthesized into unipolar required wide pulse; when radio frequency modulation is required, only bipolar high frequency narrow pulse rectification, Thus, a unipolar radio frequency modulation pulse is obtained; finally, the pulse synthesized and processed is distributed to the corresponding treatment electrode, and its polarity is controlled.
  • the pulse control method of the present invention can be applied to ablation therapy, such as tachyarrhythmia therapy, tissue ablation, tumor therapy, etc., and can also be applied to non-ablation therapy, such as nerve stimulation and defibrillation.
  • ablation therapy such as tachyarrhythmia therapy, tissue ablation, tumor therapy, etc.
  • non-ablation therapy such as nerve stimulation and defibrillation.
  • the treatment electrode is an ablation electrode
  • the frequency range of the bipolar high-frequency narrow pulse is generally 10KHz-10MHz, preferably 50KHz-500KHz.
  • the specific process steps of the above pulse control method may include:
  • Step 1 Turn on the device, initialize it first, and go to step 2 after passing the self-test;
  • Step 2 Receive the pulse parameters set by the user, charge the charging capacitor of the accumulator, wait for the user to start the pulse output command, and enter step 3 after receiving the pulse output command;
  • Step 3 Start pulse width timing, control multiplex distribution, and then enter step 4;
  • Step 4 Start the high-frequency pulse output, generate high-frequency narrow pulses, and perform corresponding pulse synthesis processing, and at the same time start the DC power supply to output high instantaneous power to charge the charging capacitor of the energy storage, and enter step 5;
  • Step 5 According to the charging capacitor voltage of the accumulator, adjust the output of the DC power supply and go to step 6;
  • Step 6 Determine whether the pulse width timing is over, if not, return to step 5, if the timing is over, go to step 7;
  • Step 7 Turn off the high-frequency pulse output, and start the pulse interval timing, go to step 8;
  • Step 8 According to the charging capacitor voltage of the accumulator, adjust the output of the DC power supply and go to step 9;
  • Step 9 Determine whether the pulse interval timing is over, if not, return to step 8, if the timing is over, go to step 10;
  • Step 10 Determine whether the output pulse of the group is completed, if not, return to step 3, if completed, enter step 11;
  • Step 11 Determine whether the output of the entire output pulse is completed. If not, start the group interval timing. After the timing is over, return to step 3. If it is completed, return to step 2 and wait for a new command.
  • the present invention first uses a high-frequency pulse generator to generate a high-frequency narrow pulse, and then performs a corresponding synthesis process on the high-frequency narrow pulse to realize the radio frequency modulation function and output a wide pulse with an arbitrary time width, which satisfies the The need for radiofrequency modulation and wider pulses during pulse ablation improves the effectiveness of ablation.
  • the output of the pulse generator is a bipolar high-frequency pulse with a higher frequency than the output pulse of the existing pulse generator, a transformer with small magnetic flux can be used like this, and the volume of the system is greatly reduced, which is beneficial to miniaturization and popularization.
  • the present invention dynamically adjusts the output power of the DC power supply according to the pulse output state, supplies power to the charging capacitor of the energy storage device with low power during the non-pulse output period, and supplies the charging capacitor of the energy storage device with high instantaneous power during the pulse output period Power supply, and discharge excess capacitor power through the fast discharge circuit of the energy storage device, thereby generating the voltage amplitude required by the pulse; because the high instantaneous power is used to replenish the charging capacitor in time during the pulse output period, no longer need Large-capacity charging capacitors are used for energy storage, which solves the problems of limited power supply and limited capacitor capacity.
  • FIG. 1 System block diagram of the existing pulse generator
  • Fig. 2 a system block diagram of a pulse generating device according to an embodiment of the present invention
  • Fig. 3 the pulse output by the pulse generating device of an embodiment of the present invention
  • Fig. 4 the pulse with high-frequency modulation output by the pulse generating device of an embodiment of the present invention
  • Fig. 5 High instantaneous power DC power supply of an embodiment of the present invention
  • FIG. 6 Control pulse during non-pulse output of high instantaneous power DC power supply according to an embodiment of the present invention
  • FIG. 7 Control pulse during high instantaneous power DC power pulse output in an embodiment of the present invention
  • Fig. 8 High-frequency pulse generator of an embodiment of the present invention
  • Fig. 9 Control pulse of a high-frequency pulse generator according to an embodiment of the present invention.
  • the high-frequency pulse generator of an embodiment of the present invention has the control pulse of high-frequency modulation
  • Fig. 11 pulse synthesizer of an embodiment of the present invention
  • Fig. 12 pulse synthesizer waveform diagram of an embodiment of the present invention
  • Fig. 13 the pulse synthesizer of an embodiment of the present invention has the waveform diagram of high-frequency modulation
  • FIG. 14 Pulse demultiplexer of an embodiment of the present invention
  • Fig. 15 a pulse demultiplexer waveform diagram of an embodiment of the present invention.
  • Fig. 16 Flowchart of the control method of the pulse generating device according to an embodiment of the present invention.
  • the present invention discloses a pulse generating device and a pulse control method.
  • a bipolar high the pulse synthesis processing is carried out, specifically including: When radio frequency modulation is not required, bipolar high-frequency narrow pulse rectification and integral filtering are synthesized into unipolar wide pulse; when radio frequency modulation is required, bipolar high frequency narrow pulses are rectified to obtain unipolar radio frequency modulated pulses; finally, the pulses processed by pulse synthesis are distributed to the corresponding treatment electrodes, and their polarity is controlled, thereby Realize pulse output with arbitrary pulse width and radio frequency modulation function. Whether or not radio frequency modulation is required is determined by the user to set the parameters of the pulse generator according to the requirements of the actual application scenario.
  • Fig. 1 is a system block diagram of an existing pulse generating device, which is connected to an external 220V AC input, and a DC is output through a DC power supply to charge the charging capacitor of the energy storage device.
  • the size of the DC voltage is controlled by the controller and is proportional to the output pulse voltage; the pulse
  • the generator is controlled by the controller to generate the required pulses, and then sent to the ablation electrodes of the pulse ablation catheter through the multiplexer.
  • the pulse generator directly generates pulse timing parameters at a time, and outputs pulses in proportion to the amplitude through the transformer.
  • Fig. 2 is a system block diagram of the pulse generating device of an embodiment of the present invention, and this pulse generating device includes controller, high instantaneous power DC power supply, energy storage device, high-frequency pulse generator, pulse synthesizer and demultiplexer, high
  • the instantaneous power DC power supply is connected to an external 220V AC input, and a high instantaneous power DC power supply outputs a DC to charge the capacitor of the energy storage device.
  • the DC voltage and current are controlled by the controller and are proportional to the output pulse voltage.
  • the power charges the charging capacitor of the accumulator, and during the pulse output period, the maximum instantaneous power is used to charge the charging capacitor of the accumulator; if the capacitor voltage of the accumulator exceeds the pulse output voltage range, the accumulator quickly discharges the circuit
  • the capacitor will be quickly discharged to the required voltage range;
  • the high-frequency pulse generator is controlled by the controller to generate specific high-frequency pulses, which are output to the pulse synthesizer through the transformer; Rectification and integral filtering obtain the envelope level, and obtain a single unipolar pulse of arbitrary width, while in radio frequency modulation, the pulse synthesizer only rectifies the high-frequency pulse to obtain a radio frequency modulation pulse; finally, it passes through the demultiplexer
  • the pulse is delivered to the ablation electrode of the ablation catheter, and the pulse polarity is controlled.
  • Fig. 3 is the pulse that the pulse generation device of an embodiment of the present invention outputs, and this pulse is without radio frequency (RF) modulation, bipolar pulse, and the amplitude, width, interval and polarity of pulse are controlled by controller, and pulse amplitude is in 100V to Between 2000V, preferably 200V-800V; pulse width and interval ranging from 100ns to 500us, preferably 10us to 150us.
  • Fig. 4 is the pulse that radio frequency (RF) modulates that the pulse generator output of an embodiment of the present invention is arranged, and the radio frequency pulse number in the pulse is determined by the pulse width and the radio frequency pulse width of setting, and pulse amplitude, width, cycle and polarity are controlled by device control.
  • RF radio frequency
  • Fig. 5 is a high instantaneous power DC power supply according to an embodiment of the present invention.
  • the structure of this power supply is similar to that of an ordinary switching power supply, but the control method is very different;
  • the charging time of the charging capacitor of the accumulator is at the level of seconds, while during the system output pulse, the DC power supply outputs with high output power, and the charging time of the charging capacitor of the energy storage is at the level of microseconds to milliseconds; this design is for During the pulse output period of the entire system, the pulse output amplitude requirement can be guaranteed with a large power supply, and the rapid discharge circuit in the energy storage can discharge the excess voltage, so as to keep the pulse amplitude unchanged; because the system is short-term Work and output pulses, so the DC power supply is also controlled by the device controller, and works at high power for a short time, so that the requirements for power supply components and heat dissipation can be lower than those for a full high-power power supply.
  • Fig. 6 is a control pulse during the non-pulse output period of the high instantaneous power DC power supply according to an embodiment of the present invention. At this time, the duty cycle of the pulse is small, and the power supply outputs with a low nominal output power.
  • Fig. 7 is a control pulse during the pulse output period of the high instantaneous power DC power supply according to an embodiment of the present invention. At this time, the duty ratio of the pulse is large, and the power supply outputs with high output power.
  • the high instantaneous power DC power supply and the fast discharge circuit of the energy storage can realize the pulse output of any voltage range.
  • Fig. 8 is a high-frequency pulse generator according to an embodiment of the present invention. It receives instructions from the controller, controls the full-bridge switch, generates specific high-frequency pulses, and outputs them to the pulse synthesizer through a transformer. Since the output is a bipolar high-frequency pulse with a higher frequency than the output pulse of the existing pulse generator, a transformer with a small magnetic flux can be used in this way, and the volume is greatly reduced, and the subsequent pulse synthesis can realize any time width. pulse.
  • Fig. 9 is the control pulse of the high-frequency pulse generator without radio frequency modulation according to an embodiment of the present invention
  • Fig. 10 is the control pulse of the high-frequency pulse generator with radio frequency modulation according to one embodiment of the present invention.
  • Fig. 11 is a pulse synthesizer according to an embodiment of the present invention, which is composed of a rectifier bridge and a filter capacitor connected by switch control.
  • the bipolar pulse output by the previous high-frequency pulse generator passes through the rectifier bridge and outputs a unipolar pulse; when there is no radio frequency modulation, the filter capacitor is connected, and the pulse duty cycle is close to 100%.
  • the pulse duty cycle is close to 100%.
  • Fig. 12 is a waveform diagram of a pulse synthesizer without high-frequency modulation according to an embodiment of the present invention.
  • Fig. 13 is a waveform diagram of a pulse synthesizer with high frequency modulation according to an embodiment of the present invention.
  • Figure 14 is a pulse demultiplexer according to an embodiment of the present invention, corresponding to each electrode, connected to the input pulse signal by a half bridge, and can output the pulse distribution to any two electrodes in the 4 electrodes, one of which is One is positive and the other is negative.
  • Fig. 15 is a waveform diagram of a pulse demultiplexer according to an embodiment of the present invention. By controlling the gate signal of the half-bridge of each electrode, bipolar pulses are output on electrodes 1 and 2.
  • the embodiment provides a pulse control method, as shown in Figure 16, the specific process steps include:
  • Step 1 start the device, first initialize, after passing the self-test, go to step 2;
  • Step 2 The device receives the pulse parameters set by the user, including pulse width, interval, amplitude, polarity, period, number, group number, and whether radio frequency modulation, etc., charges the charging capacitor of the energy storage device, and waits for the user to start the pulse Output command, enter step 3 after receiving the pulse output command;
  • Step 3 Start the pulse width timing according to the set pulse width parameters, control the multi-channel distribution, and then enter step 4;
  • Step 4 Start the high-frequency pulse output, generate corresponding high-frequency narrow pulses according to the set pulse amplitude and high-frequency frequency, and perform corresponding pulse synthesis processing, and at the same time start the DC power supply to output high instantaneous power to charge the energy storage Capacitor charging, go to step 5;
  • Step 5 Adjust the output of the DC power supply according to the voltage of the charging capacitor of the accumulator, and go to step 6; since the pulse output power is large during the pulse output period, the voltage of the charging capacitor of the accumulator will drop quickly, so the DC power supply needs to be adjusted Output, that is, use the maximum instantaneous power to charge the charging capacitor of the accumulator. If the capacitor voltage of the accumulator exceeds the pulse output voltage range, the capacitor will be quickly discharged to the required voltage range through the fast discharge circuit of the accumulator. .
  • Step 6 Determine whether the pulse width timing is over, if not, return to step 5, if the timing is over, go to step 7;
  • Step 7 Turn off the high-frequency pulse output, and start the pulse interval timing, go to step 8;
  • Step 8 According to the voltage of the charging capacitor of the accumulator, adjust the output of the DC power supply and go to step 9; since the high-frequency pulse output is turned off, the output of the DC power supply can be reduced, and the charging capacitor of the accumulator can be charged with a small charging power , when the charging capacitor is fully charged, the DC power output can be turned off.
  • Step 9 Determine whether the pulse interval timing is over, if not, return to step 8, if the timing is over, go to step 10;
  • Step 10 Determine whether the output pulse of the group is completed, if not, return to step 3, if completed, enter step 11;
  • Step 11 Determine whether the output of the entire output pulse is completed. If not, start the group interval timing. After the timing is over, return to step 3. If completed, return to step 2 and wait for a new command.

Abstract

La présente invention se rapporte au domaine technique des impulsions. Sont divulgués un appareil de génération d'impulsions et un procédé de commande d'impulsions, destinés à être utilisés pour résoudre les problèmes selon lesquels une largeur d'impulsion plus grande est difficile à réaliser et une modulation radiofréquence est difficile à réaliser pendant une thérapie par impulsions haute tension, ce qui permet d'améliorer l'efficacité de la thérapie par impulsions haute tension. Une source d'alimentation en courant continu, un condensateur de charge d'un dispositif de stockage d'énergie, un générateur d'impulsion, un synthétiseur d'impulsion et un démultiplexeur sont présents; le générateur d'impulsion est un générateur d'impulsion haute fréquence, et est utilisé pour générer une impulsion étroite haute fréquence pendant une période de sortie d'impulsion; le synthétiseur d'impulsion peut redresser une impulsion étroite haute fréquence bipolaire et effectuer ensuite un filtrage intégral pour synthétiser l'impulsion étroite haute fréquence bipolaire en une impulsion unipolaire ayant une largeur de temps requise quelconque, et peut également redresser et délivrer uniquement l'impulsion étroite haute fréquence bipolaire en tant que signal de modulation radiofréquence; et le démultiplexeur est utilisé pour distribuer l'impulsion synthétisée à une électrode thérapeutique correspondante et commander la polarité de celle-ci. La présente invention peut être appliquée à un dispositif d'ablation par impulsions, et une sortie d'impulsion ayant une largeur et une amplitude quelconques et ayant une modulation radiofréquence peut être obtenue.
PCT/CN2022/098010 2021-06-11 2022-06-10 Appareil de génération d'impulsions et procédé de commande d'impulsions WO2022258034A1 (fr)

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