CN113397689A - Switching device for composite radio frequency and irreversible electroporation - Google Patents

Abstract

Translated fromChinese

一种复合射频及不可逆电穿孔的切换装置，包括交直流切换模块、电流传感器切换模块，切换装置用于将不可逆电穿孔用的高压直流脉冲和射频消融输出的射频正弦波分时切换输出到外部的两个电极接口，切换装置分别连接射频消融模块DCAC逆变电路输出、不可逆电穿孔模块高压直流输出、主控板控制接口以及电极接口。与现有技术相比，本发明可以根据需要切换消融工作模式，进行不可逆电穿孔消融治疗，在不可逆电穿孔消融治疗结束时能用低功率消融模式输出进行针道消融。一般病灶时又能按射频消融主机使用。不仅提高了不可逆电穿孔设备治疗有效性，而且对某些复杂病例可以进行不可逆电穿孔和射频消融的复合治疗模式，大大提高了设备的临床应用范围。

A switching device for composite radio frequency and irreversible electroporation, comprising an AC-DC switching module and a current sensor switching module, the switching device is used to switch the high-voltage DC pulse for irreversible electroporation and the radio-frequency sine wave output from radio-frequency ablation to the outside by time-division switching The two electrode interfaces of the device are respectively connected to the DCAC inverter circuit output of the radio frequency ablation module, the high voltage DC output of the irreversible electroporation module, the control interface of the main control board and the electrode interface. Compared with the prior art, the present invention can switch the ablation working mode as required to perform irreversible electroporation ablation treatment, and can use low-power ablation mode output to perform needle tract ablation when the irreversible electroporation ablation treatment ends. For general lesions, it can also be used as a radiofrequency ablation host. Not only the treatment effectiveness of the irreversible electroporation device is improved, but also the composite treatment mode of irreversible electroporation and radiofrequency ablation can be performed for some complex cases, which greatly improves the clinical application scope of the device.

Description

Switching device for composite radio frequency and irreversible electroporation

Technical Field

The invention relates to the technical field of medical instruments, in particular to a switching device for composite radio frequency and irreversible electroporation.

Background

Radiofrequency (RFA) is a commonly used method of tumor ablation. This approach generates heat in the target tissue to induce clumping cell necrosis, but RFA is limited by the location of the tumor and cannot be used in heat-sensitive structures (e.g., pancreas). Irreversible electroporation ablation is a new ablation mode in the field of tumor ablation. Irreversible electroporation ablation uses high-voltage steep pulses to act on the focal site, causing permanent perforation of the cell membrane at a nanometer level, resulting in apoptosis of tumor cells. Because the therapy is less damaging to connective tissue structures and blood vessels, tumors near heat sensitive structures and blood vessels can be ablated. Irreversible electroporation ablation, however, is more complex to use than radiofrequency ablation, generally requires an external device with R-wave detection output and requires anesthesia. For common focus, the radio frequency ablation function can be adopted for ablation, and the irreversible electroporation ablation is reduced. In addition, in a minimally invasive ablation operation, needle channel ablation is usually required when ablation is finished, needle channel bleeding during needle withdrawal is prevented, and the planting risk caused by the fact that live cells of a focus on a needle are left in a needle channel area when the focus is pulled out by an ablation electrode needle is reduced. The existing irreversible electroporation ablation equipment generally does not have a special needle channel ablation function, and bleeding and planting risks exist during operation. Therefore, it is a critical need in the medical field to design an ablation device that combines ablation with irreversible electroporation.

Disclosure of Invention

In view of the above drawbacks of the prior art, the present invention provides a switching device for rf and irreversible electroporation, comprising:

the technical scheme of the invention is realized as follows:

a switching device for composite radio frequency and irreversible electroporation comprises an alternating current-direct current switching module and a current sensor switching module; the alternating current-direct current switching module is used for switching and outputting high-voltage direct current pulses for irreversible electroporation and radio frequency sine waves output by radio frequency ablation to two external electrode interfaces in a time-sharing manner, and the two external electrode interfaces can output radio frequency ablation voltage or high-voltage direct current pulse voltage; the current sensor switching module is used for measuring the current of high-voltage direct current pulse during operation or radio frequency ablation during operation, the switching device is connected with the DCAC inverter circuit output of the radio frequency ablation module, the high-voltage direct current output of the irreversible electroporation module, the main control panel control interface and the electrode interface respectively, and the switching device is further connected with the negative plate.

Preferably, the ac/dc switching module includes a first relay, a second relay, a third relay, a fourth relay and a fifth relay, the first relay, the second relay and the third relay are single-pole double-throw SPDT relays, the fourth relay and the fifth relay are double-pole single-throw DPST relays, one port of the first relay is connected to one external first electrode, one port of the second relay is connected to another external second electrode, two ports of the first relay are connected to a port of the fourth relay, three ports of the first relay are connected to a second port of the third relay, two ports of the second relay are connected to a second port of the fourth relay, three ports of the second relay are connected to a third port of the third relay, one port of the third relay is connected to a port of the fifth relay, and two ports of the fifth relay are connected to a negative plate, the third port and the fourth port of the fourth relay are connected with the high-voltage direct-current pulse output end of the irreversible electroporation module, and the third port and the fourth port of the fifth relay are connected with the radio-frequency sine wave output end of the radio-frequency ablation module.

Preferably, the current sensor switching module comprises a first current sensor, a second current sensor and a sixth relay, the first current sensor adopts a current transformer MCT-1 capable of testing alternating current, the second current sensor adopts a Hall current sensor HS-PKD capable of testing direct current, the first current sensor and the first current sensor are connected with the main control board control interface through the sixth relay, and the sixth relay is a double-pole double-throw switch.

Compared with the prior art, the invention has the following beneficial effects:

the switching device of the composite radio frequency and irreversible electroporation can switch the ablation working mode according to the requirement, can perform irreversible electroporation ablation treatment, and can output in a low-power ablation mode to perform needle channel ablation when the irreversible electroporation ablation treatment is finished. The common focus can be used according to a full radio frequency ablation mode. The treatment effectiveness of the irreversible electroporation equipment is improved, a composite treatment mode of irreversible electroporation and radio frequency ablation can be carried out on some complex cases, and the clinical application range of the equipment is greatly improved. In addition, the radio frequency ablation output can be hundreds of volts of sine waves, and the irreversible electroporation mode output is thousands of volts of high-voltage direct current pulses, so that the compound treatment mode of irreversible electroporation and radio frequency ablation can be easily realized.

Drawings

FIG. 1 is a schematic structural diagram of an AC/DC switching module according to the present invention;

FIG. 2 is a schematic structural diagram of a current sensor switching module according to the present invention;

fig. 3 is a schematic structural diagram of the switching device of the present invention in a complete machine.

In the figure: the system comprises aDC power supply 100, a radiofrequency ablation module 200, aDCDC booster circuit 210, aDCAC inverter circuit 220, anirreversible electroporation module 300, a high-voltage power supply 310, a charge anddischarge control 320, a high-voltagedirect current output 330, a maincontrol board module 400, amain control board 410, avoltage sensor 430, atemperature sensor 440, atouch screen 450, an R wavesynchronous input interface 460, aswitching device 500, afirst relay 510, asecond relay 520, athird relay 530, afourth relay 540, afifth relay 550, asixth relay 560, a firstcurrent sensor 570, a secondcurrent sensor 580, afirst electrode interface 600, asecond electrode interface 700 and anegative plate 800.

Detailed Description

The present invention will now be described more fully hereinafter with reference to the accompanying drawings, in which embodiments of the invention are shown.

A switching device for composite radio frequency and irreversible electroporation, theswitching device 500 comprises an AC/DC switching module and a current sensor switching module; the alternating current-direct current switching module is used for switching and outputting high-voltage direct current pulses for irreversible electroporation and radio frequency sine waves output by radio frequency ablation to two external electrode interfaces in a time-sharing manner, the two external electrode interfaces can output radio frequency ablation voltage or high-voltage direct current pulse voltage, and the two electrode interfaces are afirst electrode interface 600 and asecond electrode interface 700 respectively; the current sensor switching module is used for measuring the current of high-voltage direct current pulse during operation or radio frequency ablation during operation, theswitching device 500 is respectively connected with theDCAC inverter circuit 220 output of the radiofrequency ablation module 200, the high-voltage direct current output of the irreversible electroporation module, the control interface of themain control board 410 and the electrode interface, and theswitching device 500 is further connected with thenegative plate 800.

As shown in fig. 1, the ac/dc switching module includes afirst relay 510, asecond relay 520, athird relay 530, afourth relay 540 and afifth relay 550, thefirst relay 510, thesecond relay 520 and thethird relay 530 are single-pole double-throw SPDT relays, thefourth relay 540 and thefifth relay 550 are double-pole single-throw DPST relays, one port of thefirst relay 510 is connected to an externalfirst electrode interface 600, one port of thesecond relay 520 is connected to an externalsecond electrode 700, two ports of thefirst relay 510 are connected to ports of thefourth relay 540, two ports of thefirst relay 510 are connected to ports of thethird relay 530, two ports of thesecond relay 520 are connected to ports of thefourth relay 540, three ports of thesecond relay 520 are connected to ports of thethird relay 530, one port of thethird relay 530 is connected to a port of thefifth relay 550, two ports of thefifth relay 550 are connected to thenegative plate 800, three ports and four ports of thefourth relay 540 are connected to the high-voltage direct-current pulse output end of theirreversible electroporation module 300, and three ports and four ports of thefifth relay 550 are connected to the radio-frequency sine wave output end of the radio-frequency ablation module 200.

As shown in fig. 2, the current sensor switching module includes a firstcurrent sensor 570, a secondcurrent sensor 580 and asixth relay 560, the firstcurrent sensor 570 employs a current transformer MCT-1 capable of testing alternating current, the secondcurrent sensor 580 employs a hall current sensor HS-PKD capable of testing direct current, the firstcurrent sensor 570 and the firstcurrent sensor 580 are connected to the control interface of themain control board 410 through thesixth relay 560, and thesixth relay 560 is a double-pole double-throw switch.

As shown in fig. 3, which is a schematic structural diagram of the switching device of the present invention in a complete machine, the complete machine includes the following components:

theDC power supply 100 comprises a medical-grade AC-DC power supply module with 220V input and 24V output, theDC power supply 100 is divided into three paths, one path is used for the radiofrequency ablation module 200, the other path is used for theirreversible electroporation module 300, and the last path is used for supplying power to the maincontrol panel module 400;

the radiofrequency ablation module 200, the radiofrequency ablation module 200 includes aDCDC boost circuit 210 and aDCAC inverter circuit 220, wherein theDCDC boost circuit 210 adopts a conventional half-bridge DC/DC converter, and adjusts and outputs a boosted DC voltage according to a PWM duty ratio given by the maincontrol board module 400, and the DC-AC inverter circuit 220 adopts a conventional full-bridge inverter structure, and is configured to invert the DC voltage output by the preceding-stageDCDC boost circuit 210 into a 480KHz sinusoidal AC voltage;

a non-reversibleelectroporation module 300, the non-reversibleelectroporation module 300 for generating a high voltage DC pulse, the non-reversibleelectroporation module 300 comprising a highvoltage power supply 310, a charge anddischarge control 320, a highvoltage DC output 330. Wherein the high-voltage power supply is used for converting the 24V input direct-current voltage into the upper kilovolt direct-current high voltage required by the output adjustable steep pulse therapy. This high voltage output outputs a high voltage dc pulse to the switching device via the charge and discharge control unit controlled by the maincontrol board module 400. Irreversible electroporation therapy is high voltage direct current pulses, typically on the order of thousands of volts with currents up to 50A, whereas radio frequency ablation is typically hundreds of volts alternating sine waves with currents less than 5A. The first current sensor uses a current transformer MCT-1 which can measure alternating current, and the maximum measurable alternating current is 10A. The second current sensor adopts a Hall current sensor HS-PKD capable of measuring direct current, the maximum measurable direct current is 100A, and the current is compositely output to the main control board through the relay 6 to carry out current AD sampling conversion.

The maincontrol panel module 400 comprises amain control panel 410, avoltage sensor 430, atemperature sensor 440 and atouch screen 450, wherein themain control panel 410 is respectively connected with thevoltage sensor 430, thetemperature sensor 440 and thetouch screen 450, the maincontrol panel module 400 is further connected with an R wavesynchronous input interface 460, and the main control panel controls a charge and discharge control unit according to the R wave synchronous input interface so that output high-voltage direct-current irreversible electroporation pulses and R waves keep synchronous;

theswitching device 500 comprises an alternating current/direct current switching module and a current sensor switching module; the alternating current-direct current switching module is used for switching and outputting high-voltage direct current pulses for irreversible electroporation and radio frequency sine waves output by radio frequency ablation to two external electrode interfaces in a time-sharing manner, the two external electrode interfaces can output radio frequency ablation voltage or high-voltage direct current pulse voltage, and the two electrode interfaces are afirst electrode interface 600 and asecond electrode interface 700 respectively; the current sensor switching module is used for measuring the current of the high-voltage direct current pulse during operation or the radio frequency ablation during operation, theswitching device 500 is respectively connected with the output of theDCAC inverter circuit 220 of the radiofrequency ablation module 200, the high-voltage direct current output of theirreversible electroporation module 300, the control interface of themain control board 410 and the electrode interface, and theswitching device 500 is further connected with thenegative plate 800.

The alternating current and direct current switching module comprises afirst relay 510, asecond relay 520, athird relay 530, afourth relay 540 and afifth relay 550, wherein thefirst relay 510, thesecond relay 520 and thethird relay 530 are single-pole double-throw SPDT relays, thefourth relay 540 and thefifth relay 550 are double-pole single-throw DPST relays, one port of thefirst relay 510 is connected with one externalfirst electrode interface 600, one port of thesecond relay 520 is connected with the other externalsecond electrode 700, two ports of thefirst relay 510 are connected with one port of thefourth relay 540, three ports of thefirst relay 510 are connected with two ports of thethird relay 530, two ports of thesecond relay 520 are connected with two ports of thefourth relay 540, three ports of thesecond relay 520 are connected with three ports of thethird relay 530, and one port of thethird relay 530 is connected with one port of thefifth relay 550, two ports of thefifth relay 550 are connected with thenegative plate 800, three ports and four ports of thefourth relay 540 are connected with the high-voltage direct-current pulse output end of theirreversible electroporation module 300, and three ports and four ports of thefifth relay 550 are connected with the radio-frequency sine wave output end of the radio-frequency ablation module 200;

the current sensor switching module comprises a firstcurrent sensor 570, a secondcurrent sensor 580 and asixth relay 560, the firstcurrent sensor 570 adopts a current transformer MCT-1 capable of testing alternating current, the secondcurrent sensor 580 adopts a Hall current sensor HS-PKD capable of testing direct current, the firstcurrent sensor 570 and the firstcurrent sensor 580 are connected with a control interface of themain control board 410 through thesixth relay 560, and thesixth relay 560 is a double-pole double-throw switch.

The whole machine embodiment:

the DC power supply adopts a medical AC-DC power supply module with 220V input and 24V output, the DCDC boosting module adopts a 24V input adjustable half-bridge DC/DC conversion module, and 96V direct-current voltage is output by default. The DC-AC inverter circuit adopts a traditional full-bridge inverter structure and is used for inverting the direct current voltage output by the pre-stage DCDC into sinusoidal alternating current voltage with peak-to-peak value of 300V and frequency of 480KHz required by radio frequency ablation. The needle channel is inverted into sinusoidal alternating voltage with peak value of 100V and frequency of 480KHz during ablation. The temperature sensor adopts a Pt type thermocouple sensor to measure the temperature of the electrode, and the voltage sensor adopts a voltage transformer to measure the voltage during the radio frequency ablation work.

The irreversible electroporation module consists of a high-voltage power supply, charge-discharge control and high-voltage direct current output. And outputting high-voltage direct current electric pulses required by irreversible electroporation under the control of the main control panel, wherein the frequency of the electric pulses is in the range of 1Hz to 300KHz, and the amplitude of the electric pulses is in the range of 1000VDC to 6,000 VDC.

The first relay, the second relay and the third relay are JPK-2-SF type vacuum high-voltage SPDT relays, and the fourth relay and the fifth relay respectively adopt JPK-13 high-voltage vacuum double-pole double-throw DPDT relays to realize the function of a double-pole single-throw DPST relay. And when the irreversible electroporation is ablated, the fifth relay is switched off, the fourth relay is switched on, and the first relay and the second relay switch select the high-voltage direct-current pulse side to carry out irreversible electroporation treatment. After the operation is finished, the system is switched to a radio frequency needle withdrawing ablation working mode, the fourth relay is switched off, the fifth relay is switched on, the first relay and the second relay select the radio frequency sine wave output side, and the third relay is repeatedly and sequentially switched and output to the first relay and the second relay. The main control board controls the PWM output duty ratio according to the temperature measured on each ablation electrode so as to adjust the final radiofrequency ablation sine wave voltage, 480KHz sine waves are sequentially output between the ablation electrodes, and the temperature of each ablation electrode is controlled to be at the temperature required by needle track ablation. The first relay, the second relay and the third relay are JPK-2-SF type vacuum high-voltage SPDT relays, and the fourth relay and the fifth relay are JPK-13 high-voltage vacuum double-pole double-throw DPDT relays. And when the irreversible electroporation is ablated, the fifth relay is switched off, the fourth relay is switched on, and the first relay and the second relay switch select the high-voltage direct-current pulse side to carry out irreversible electroporation treatment. After the system is switched to a radio frequency needle withdrawing ablation working mode, the fourth relay is switched off, the fifth relay is switched on, the first relay and the second relay select the radio frequency sine wave output side, and the third relay is repeatedly and sequentially switched and output to the first relay and the second relay. The main control board controls the PWM output duty ratio according to the temperature measured on each ablation electrode so as to adjust the final radiofrequency ablation sine wave voltage, 480KHz sine waves are sequentially output between the ablation electrodes, and the temperature of each ablation electrode is controlled to be at the temperature required by needle track ablation. A half-bridge DC/DC converter is adopted, and a full-bridge inversion structure is adopted to invert the direct current voltage output by the front stage into 480KHz sine alternating current voltage.

By integrating the structure of the invention, when the device is used for only irreversible electroporation ablation, the system is switched to a radio frequency needle withdrawing ablation working mode after the irreversible electroporation ablation is finished, the PWM output duty ratio is controlled according to the temperature measured on each ablation electrode, and 480KHz sine waves are sequentially output between the ablation electrodes and the negative plate, so that the energy output by the ablation electrodes can only ablate the needle channel, and the bleeding and focus living cells are prevented from remaining in the needle channel area and do not damage ablation heat sensitive structures and blood vessels; when the device is used for common radio frequency ablation, the master control board controls the radio frequency ablation module to output 480KHz sine wave energy to the ablation electrode for conventional heat ablation, and can also be switched to the irreversible electroporation module to output direct-current high-voltage pulses for irreversible electroporation composite treatment course as required after ablation is finished, so that the complete ablation of a focus is ensured, and the success rate of an ablation operation is further improved.

Claims (3)

1. The switching device for the composite radio frequency and the irreversible electroporation is characterized by comprising an alternating current-direct current switching module and a current sensor switching module; the alternating current-direct current switching module is used for switching and outputting high-voltage direct current pulses for irreversible electroporation and radio frequency sine waves output by radio frequency ablation to two external electrode interfaces in a time-sharing manner, and the two external electrode interfaces can output radio frequency ablation voltage or high-voltage direct current pulse voltage; the current sensor switching module is used for measuring the current of high-voltage direct current pulse during operation or radio frequency ablation during operation, the switching device is connected with the DCAC inverter circuit output of the radio frequency ablation module, the high-voltage direct current output of the irreversible electroporation module, the main control panel control interface and the electrode interface respectively, and the switching device is further connected with the negative plate.

2. The composite rf and irreversible electroporation switching apparatus of claim 1, wherein the ac/dc switching module comprises a first relay, a second relay, a third relay, a fourth relay, and a fifth relay, the first relay, the second relay, the third relay are SPDT relays, the fourth relay, and the fifth relay are DPST relays, the first relay port is connected to one external first electrode, the second relay port is connected to another external second electrode, the first relay port is connected to a fourth relay port, the first relay port is connected to a third relay port, the second relay port is connected to a fourth relay port, the second relay port is connected to a third relay port, the third relay port is connected to a fifth relay port, the two ports of the fifth relay are connected with the negative plate, the three ports and the four ports of the fourth relay are connected with the high-voltage direct-current pulse output end of the irreversible electroporation module, and the three ports and the four ports of the fifth relay are connected with the radio-frequency sine wave output end of the radio-frequency ablation module.

3. The combined rf and irreversible electroporation switching apparatus of claim 2, wherein the current sensor switching module comprises a first current sensor, a second current sensor and a sixth relay, the first current sensor employs a current transformer MCT-1 for testing ac, the second current sensor employs a hall current sensor HS-PKD for testing dc, the first current sensor and the first current sensor are connected to the main control board control interface through the sixth relay, and the sixth relay is a double-pole double-throw switch.

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