Selectable applicable IRE and RFA hybrid ablation system

Abstract

The utility model relates to the technical field of tumor ablation, in particular to a selectable and applicable IRE and RFA mixed ablation system and a control method thereof. A selectable and applicable IRE and RFA mixed ablation system comprises an electrode needle, a data acquisition module, a heart rate monitoring unit, an output control module and an upper computer system, the output control module comprises a high-voltage pulse unit, a radio frequency current unit and an output switching control unit, and the upper computer system comprises a storage module and a control module. The storage module stores data acquired by the heart rate monitoring unit and the data acquisition module, and the control module receives and processes the data of the storage module and further controls the output control module to output a high-voltage pulse and then output a radio-frequency current or to output the radio-frequency current and then output the high-voltage pulse. Compared with single RFA or IRE ablation treatment, the mixed ablation technology combining the RFA ablation mode and the IRE ablation mode has the advantages that a larger ablation range can be obtained through mixed ablation, and a larger tumor can be ablated under single-time needle insertion.

Description

Technical Field

[0001] The utility model relates to the technical field of tumor ablation, in particular to an IRE and RFA hybrid ablation system which can be selectively applied. Background Art

[0002] In the 21st century, with the extension of life expectancy, the incidence and mortality of tumors around the world have also increased dramatically. One of the reasons for the high number of deaths is the limited range of ablation energy transmission in minimally invasive ablation surgery, that is, the limited ablation range. The two most commonly used ablation methods are radiofrequency ablation (RFA) and irreversible electroporation (IRE). Both RFA and IRE achieve ablation of the target biological tissue by puncturing the electrode needle into the target biological tissue position and releasing different energies. For RFA, the target position is generated by resistive heat generated by the output of radiofrequency current by the electrode needle, thereby causing the target to heat up and cause coagulative necrosis. However, when the temperature of biological tissue reaches 100°C, carbonization will occur in the biological tissue. Carbonized tissue is a poor conductor of electricity. It will surround the discharge end of the electrode needle, thereby cutting off the transmission of current and stopping RFA treatment. Therefore, the ablation range that RFA can achieve is limited, and the ablation diameter is often less than 3 cm. For IRE, the target position is bombarded by outputting high-voltage pulses, thereby causing irreversible holes in the cell membrane in the target to cause cell apoptosis or lysis necrosis. IRE is a non-thermal treatment method to compensate for RFA, a temperature-based ablation treatment method, and avoids the situation where RFA cannot completely ablate due to heat dissipation near structures with strong heat dissipation such as large blood vessels. However, since the high-voltage electric field formed by the electrode needle decreases in square order as the distance from the electrode needle increases, and the output voltage cannot be increased indefinitely due to safety considerations (generally kilovolts), the effective high-voltage electric field area that can be formed by the electrode needle in IRE treatment is very limited, and the ablation range is often smaller than RFA.

[0003] Patent with announcement number CN113100917B discloses a method of hybrid IRE ablation and RF ablation using a sine wave generator. Unlike the square wave used in normal IRE, this patent replaces the square wave with a sine wave, that is, the main purpose is to achieve the effect of IRE ablation by using a sine wave, but it is not actually the energy output mode of IRE.

[0004] The patent with announcement number CN116712158B discloses a multi-modal physical field tumor ablation treatment system, which integrates multiple ablation technologies on the same platform and selects a single energy or at least two composite energies as needed. It does not involve energy mixing, but only realizes the output of multiple energies. Utility Model Content

[0005] The technical problem to be solved by the utility model is to overcome the deficiencies in the prior art and provide a selectively applicable IRE and RFA hybrid ablation system.

[0006] The technical solution adopted by the utility model to solve the technical problem is: a selectively applicable IRE and RFA hybrid ablation system, comprising:

[0007] The electrode needle is inserted into the area to be ablated in the human body and has a temperature sensor integrated thereon;

[0008] The data acquisition module includes a voltage / current measurement unit for collecting and processing system voltage / current signals, a conductivity measurement unit for collecting and processing conductivity signals of biological tissues near the electrode needles, and a temperature measurement unit for collecting and processing temperature signals of the temperature sensor;

[0009] A heart rate monitoring unit, used to monitor the actual heart rate of the human body;

[0010] An output control module, which includes a high-voltage pulse unit, a radio frequency current unit, and an output switching control unit for switching the output of the high-voltage pulse unit and the radio frequency current unit;

[0011] The host computer system includes a storage module and a control module. The storage module stores the data collected by the heart rate monitoring unit and the data acquisition module. The control module receives the data from the storage module for processing, and then controls the output control module to output high-voltage pulses first and then radio frequency currents, or to output radio frequency currents first and then high-voltage pulses.

[0012] Furthermore, it also includes a display module for displaying the voltage and current data collected and processed by the voltage and current measurement unit.

[0013] Furthermore, the display module is an oscilloscope.

[0014] Furthermore, the high-voltage pulse unit and the radio frequency current unit are connected to an output control module, the high-voltage pulse unit includes a voltage regulation control circuit and a MOS tube control circuit, and the radio frequency current unit includes a radio frequency voltage control circuit.

[0015] Furthermore, the voltage regulation control circuit is provided with a DC / DC converter, the MOS tube control circuit is a bridge circuit, and the radio frequency voltage control circuit is provided with a DC / AC converter, a high frequency filter and a transformer.

[0016] Furthermore, the voltage / current measuring unit, the conductivity measuring unit and the temperature measuring unit all have an acquisition card and an A / D converter, and the voltage / current detection unit includes a voltage sensor and a current sensor.

[0017] Furthermore, the control module has a PID controller.

[0018] The beneficial effects of the utility model are as follows: the utility model combines the hybrid ablation technology of RFA and IRE, and compared with single RFA or IRE ablation treatment, the hybrid ablation can obtain a larger ablation range, that is, it can ablate a larger tumor with a single needle insertion; the conductivity enhancement effects of the two ablation methods can be independently superimposed, thereby expanding the ablation range; the two ablation methods influence each other, RFA enhances the intensity of molecular thermal motion, and can also reduce the difficulty of IRE perforating cell membranes, thereby expanding the ablation range of IRE; after IRE perforation, the fluidity of the liquid in the biological tissue is enhanced, which helps to enhance the heat dissipation of the biological tissue near the electrode needle during RFA ablation, helps to prolong the time point of carbonization of the biological tissue, prolongs the effective ablation time of RFA, and expands the ablation range. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The utility model is further described below in conjunction with the accompanying drawings and implementation modes.

[0020] Figure 1 It is a structural schematic diagram of the first embodiment of the utility model.

[0021] Figure 2 It is a circuit diagram of the first embodiment of the utility model.

[0022] Figure 3 It is a control block diagram of the first embodiment of the utility model.

[0023] Figure 4 It is a flow chart of the second embodiment of the present utility model.

[0024] Figure 5 This is a schematic diagram of waveform output of hybrid ablation based mainly on RFA in the second embodiment of the present invention.

[0025] Figure 6 It is a schematic diagram of the change of conductivity in the hybrid ablation mainly using RFA in the second embodiment of the present invention.

[0026] Figure 7 It is a schematic diagram of temperature changes in hybrid ablation using RFA as the main method in the second embodiment of the present invention.

[0027] Figure 8 This is a schematic diagram of waveform output of hybrid ablation based mainly on IRE in the second embodiment of the present invention.

[0028] Fig. 9 It is a schematic diagram of the change of conductivity in the hybrid ablation mainly based on IRE in the second embodiment of the present invention.

[0029] Fig.10It is a schematic diagram of temperature change in hybrid ablation based on IRE in the second embodiment of the present invention.

[0030] In the figure: 1. Electrode needle, 2. Data acquisition module, 21. Voltage / current measurement unit, 22. Conductivity measurement unit, 23. Temperature measurement unit, 3. Output control module, 31. High voltage pulse unit, 311. Voltage regulation control circuit, 312. MOS tube control circuit, 32. Radio frequency current unit, 33. Output switching control unit, 4. Heart rate monitoring unit, 5. Host computer system, 51. Storage module, 52. Control module, 6. Display module. DETAILED DESCRIPTION

[0031] The present invention is now further described in conjunction with the accompanying drawings. These drawings are simplified schematic diagrams that only illustrate the basic structure of the present invention in a schematic manner, and therefore only show the components related to the present invention.

[0032] Embodiment 1

[0033] like Figure 1 As shown, an optionally applicable IRE and RFA hybrid ablation system includes an electrode needle 1, a data acquisition module 2, an output control module 3, a heart rate monitoring unit 4, a host computer system 5 and a display module 6, wherein the electrode needle 1 has two types, one is two separate electrode needles, one positive electrode and one negative electrode, and the other is that the positive and negative electrodes are integrated on one electrode needle. Any one of them can be selected in this embodiment.

[0034] The electrode needle 1 extends into the area to be ablated in the human body, and a temperature sensor is integrated thereon; the data acquisition module 2 includes a voltage / current measuring unit 21 for collecting and processing the system voltage / current signal, a conductivity measuring unit 22 for collecting and processing the conductivity signal of the biological tissue near the electrode needle 1, and a temperature measuring unit 23 for collecting and performing temperature measurement on the temperature sensor; the heart rate monitoring unit 4 is used to monitor the actual heart rate of the human body; the output control module 3 includes a high-voltage pulse unit 31, a radio frequency current unit 32, and an output switching control unit 33 for switching the outputs of the high-voltage pulse unit 31 and the radio frequency current unit 32; the host computer system 5 includes a storage module 51 and a control module 52, the storage module 51 stores the data collected by the heart rate monitoring unit 4 and each unit of the data acquisition module 2, the control module 52 receives the data from the storage module 51 for processing, and then controls the output control module 3 to output a high-voltage pulse first and then a radio frequency current, or to output a radio frequency current first and then a high-voltage pulse; the display module 6 is used to display the voltage and current data collected and processed by the voltage and current measurement units, and an oscilloscope is preferably used.

[0035] like Figure 2 and Figure 3As shown, the high-voltage pulse unit 31 and the radio frequency current unit 32 are connected to the output control module 3. The high-voltage pulse unit 31 includes a voltage regulation control circuit 311 and a MOS tube control circuit 312. The voltage regulation control circuit 311 is provided with a DC / DC converter, and the MOS tube control circuit 312 is a bridge circuit. The radio frequency current unit 32 includes a radio frequency voltage control circuit, and the radio frequency voltage control circuit is provided with a DC / AC converter, a high-frequency filter and a transformer.

[0036] like Figure 3 As shown, the voltage / current measuring unit 21, the conductivity measuring unit 22 and the temperature measuring unit 23 all have an acquisition card and an A / D converter, the voltage / current detection unit 21 includes a voltage sensor and a current sensor, and the control module 52 has a PID controller.

[0037] Embodiment 2

[0038] like Figure 4 As shown, a control method for a selectively applicable IRE and RFA hybrid ablation system includes the following process steps:

[0039] S1, the electrode needle 1 is percutaneously punctured to the target position of the area to be ablated, and the tail port of the electrode needle 1 is connected to the system output port, and the heart rate monitoring unit 4 is turned on to monitor the actual heart rate;

[0040] S2. According to the medical imaging data, the treatment parameters are set on the upper computer system 5 and the hybrid ablation mainly based on RFA or mainly based on IRE is selected; wherein, the treatment parameters are set while also setting the target temperature (T_t), target resistance value (ΔR_t), conductivity difference (Δσ_t), target treatment time (t_t), current safety threshold (I_t), and target output pulse train number (N_t);

[0041] S3. If hybrid ablation with RFA as the main method is chosen,

[0042] (a) The high-voltage pulse unit 31 outputs multiple high-voltage pulse trains to bombard the biological tissue near the electrode needle 1, and the conductivity of the biological tissue environment is improved while the IRE ablation;

[0043] During the discharge process, the data acquisition unit 2 collects the voltage and current data output by the system circuit through the voltage sensor and the current sensor, and transmits them to the voltage / current measurement unit 21 in real time or at intervals for data processing, and finally sends the processed voltage / current data (V_out / I_out) to the storage module 51 for storage and display on the oscilloscope, as shown in FIG. Figure 5 As shown;

[0044] At the same time, during the discharge process, the data acquisition unit 2 collects the temperature data of the biological tissue near the electrode needle 1 through the temperature sensor in the electrode needle 1, and transmits it to the temperature measurement unit 23 in real time or at intervals for data processing, and finally sends the processed temperature (T_m) data to the storage module 51 for storage and feedback to the host computer system 5. The temperature change is as follows Figure 7 As shown;

[0045] At the same time, in the gap between the pulse trains, the data acquisition unit 2 measures the conductivity of the biological tissue near the electrode needle 1 through the positive and negative electrodes at the discharge end of the electrode needle 1, and transmits the collected signal to the conductivity measurement unit 22 for data processing to obtain the conductivity (σ_m) and resistance value (R_m) data, and finally sends the processed data to the storage module 51 for storage and feedback to the host computer system 5. The conductivity changes as shown in Figure 6 As shown;

[0046] (b) The heart rhythm monitoring unit 4 sends the ECG signal to the storage module 51 for storage in real time, and feeds it back to the host computer system 5; the host computer system 5 determines whether the ECG signal is normal, and if so, proceeds to the next step; if abnormal, stops the output immediately; the host computer system 5 determines whether the current (I_out) exceeds the set current safety threshold (I_t), and if so, stops IRE ablation; if not, proceeds to the next step;

[0047] (c) After receiving the data of conductivity (σ_m) and resistance value (R_m), the host computer system performs AND gate operation. When the conductivity (σ_m) increases with the output of the pulse train, and the resistance value (R_m) decreases with the output of the pulse train; and at the same time, when the number of pulse train outputs N is less than the target number of output pulse trains (N_t), IRE ablation continues and returns to step (a), otherwise proceed to the next step;

[0048] (d) After the high-voltage pulse stops outputting, that is, after the IRE treatment stops, the radiofrequency current starts outputting, that is, the RFA treatment starts;

[0049] (e) data collection, processing and feedback of the data collection unit 2 during the continuous discharge process;

[0050] (g) Determine whether the total treatment time (t) reaches the target treatment time (t_t). If so, all ablations are completed; if not, proceed to the next step;

[0051] (h) After receiving the temperature (T_m), conductivity (σ_m) or resistance value (R_m) data, the host computer system 5 performs an OR gate operation. When the conductivity (σ_m) starts to decrease, and the maximum conductivity (σ_max) in the current RFA ablation minus the current conductivity (σ_m) is greater than the set conductivity difference (Δσ_t), on the contrary, the resistance value (R_m) starts to increase, and the current resistance (R_m) minus the minimum resistance (R_min) in the current treatment is greater than the target resistance value (ΔR_t); or the temperature (T_m) is greater than the set target temperature (T_t), RFA ablation is stopped, and after waiting for a time t, it is switched to IRE ablation and returns to step (a); otherwise, RFA ablation is continued;

[0052] If hybrid ablation with IRE as the main approach is chosen,

[0053] (i) First, the radio frequency current unit 32 outputs radio frequency current to perform RFA ablation to increase the temperature of biological tissue;

[0054] During the discharge process, the data acquisition unit 2 collects the voltage and current data output by the system circuit through the voltage sensor and the current sensor, and transmits them to the voltage / current measurement unit 21 in real time or at intervals for data processing, and finally sends the processed voltage and current data (V_out / I_out) to the storage module 51 for storage and display on the oscilloscope, as shown in FIG. Figure 8 As shown;

[0055] At the same time, during the discharge process, the data acquisition unit 2 collects the temperature data of the biological tissue near the electrode needle 1 through the temperature sensor in the electrode needle 1, and transmits it to the temperature measurement unit 23 in real time or at intervals for data processing, and finally sends the processed temperature data (T_m) to the storage module 51 for storage and feedback to the host computer system 5. The temperature change is as follows Fig.10 As shown;

[0056] At the same time, in the gap between the pulse trains, the data acquisition unit 2 measures the conductivity of the biological tissue near the electrode needle 1 through the positive and negative electrodes at the discharge end of the electrode needle 1, and transmits the collected signal to the conductivity measurement unit 22 for data processing to obtain the conductivity (σ_m) and resistance value (R_m) data, and finally sends the processed data to the storage module 51 for storage and feedback to the host computer system 5. The conductivity changes as shown in Fig. 9 As shown;

[0057] (ii) After receiving the temperature data (T_m), the host computer system 5 adjusts the output RF current through the PID controller feedback to maintain the temperature (T_m) within the range of ±ΔT of the target temperature (T_t) for t time. When the time is reached, RFA ablation is stopped and immediately switched to IRE ablation;

[0058] (iii) the high-voltage pulse unit 31 starts to output a high-voltage pulse train to perform IRE ablation;

[0059] (iv) collecting, processing and feeding back data by the data collection unit 2 during the discharge process;

[0060] (v) The heart rhythm monitoring unit 4 sends the ECG signal to the storage module 51 for storage in real time, and feeds it back to the host computer system 5; the host computer system 5 determines whether the ECG signal is normal, and if so, proceeds to the next step; if abnormal, stops the output immediately; the host computer system 5 determines whether the current (I_out) exceeds the set current safety threshold (I_t), and if so, stops IRE ablation; if not, proceeds to the next step;

[0061] (vi) After receiving the conductivity (σ_m) and resistance (R_m) data, the host computer system performs AND gate operation. When the conductivity (σ_m) increases with the output of the pulse train, the resistance (R_m) decreases with the output of the pulse train; and the number of pulse train outputs N is less than the target number of output pulse trains (N_t), IRE ablation continues, otherwise all ablations are terminated;

[0062] S4. Turn off the output, save the data, and remove the electrode needle.

[0063] The type of hybrid ablation is determined based on medical imaging data, specifically: if the area to be ablated is near a large blood vessel, hybrid ablation based on IRE is selected to reduce the impact of heat dissipation on the ablation range; if the ablation range is large, hybrid ablation based on RFA is selected. In addition, if you want to reduce damage to tissue structure, hybrid ablation based on IRE may be preferred because IRE does not damage tissue structure. Now clinically, IRE ablation or RFA ablation will be selected based on the characteristics of different areas to be ablated. If IRE ablation was used before, hybrid ablation based on IRE can be selected to increase the ablation range of a single IRE; conversely, if RFA ablation was used before, hybrid ablation based on RFA can be selected to increase the ablation range of a single RFA.

[0064] Compared with single RFA or IRE ablation, the hybrid ablation of this embodiment can obtain a larger ablation range, that is, it can ablate a larger tumor with a single needle insertion. The principle is: the influence of the conductivity of biological tissue on the effect of electric current. The change mechanism of the conductivity of biological tissue by RFA and IRE ablation is completely different. RFA ablation is based on increasing the temperature to increase the intensity of molecular thermal motion, thereby increasing the conductivity; IRE ablation is based on the exchange of internal and external substances caused by cell membrane perforation to increase the ion concentration of the extracellular matrix, thereby increasing the conductivity. Therefore, the conductivity enhancement effect of these two ablation methods can be independently superimposed, thereby expanding the ablation range.

[0065] Compared with the hybrid ablation of RFA and IRE in the prior art, the hybrid ablation mainly based on RFA has three logical judgments: first, IRE ablation is performed to determine whether the end condition is met; if not, it is always in the IRE ablation cycle; second, after the end condition of IRE ablation is met, RFA ablation is performed to determine whether the conditions of hybrid ablation are met; if not, it is determined whether the end condition of RFA ablation is met; if not, it is always in the RFA ablation cycle. Compared with the hybrid ablation mainly based on IRE, there is a double logical judgment: first, RFA ablation is performed to determine whether the end condition is met; if not, it is always in the RFA ablation cycle; second, after the end condition of RFA ablation is met, IRE ablation is performed to determine whether the end condition is met; if not, it is always in the IRE ablation cycle.

[0066] The above-mentioned implementation mode is only for illustrating the technical concept and features of the utility model, and its purpose is to enable people familiar with this technology to understand the content of the utility model and implement it. It cannot be used to limit the protection scope of the utility model. All equivalent changes or modifications made according to the spirit of the utility model should be included in the protection scope of the utility model.

Claims

1. A hybrid ablation system of IRE and RFA can be selected, characterized by: include: An electrode needle (1) is inserted into the area to be ablated in the human body and is integrated with a temperature sensor; A data acquisition module (2), comprising a voltage / current measurement unit (21) for collecting and processing system voltage / current signals, a conductivity measurement unit (22) for collecting and processing conductivity signals of biological tissues near the electrode needle (1), and a temperature measurement unit (23) for collecting and processing temperature signals of the temperature sensor; A heart rate monitoring unit (4), used to monitor the actual heart rate of a human body; An output control module (3), comprising a high-voltage pulse unit (31), a radio frequency current unit (32), and an output switching control unit (33) for switching the outputs of the high-voltage pulse unit (31) and the radio frequency current unit (32); The host computer system (5) comprises a storage module (51) and a control module (52), wherein the storage module (51) stores data collected by the heart rate monitoring unit (4) and the data collection module (2), and the control module (52) receives the data from the storage module (51) for processing, thereby controlling the output control module (3) to first output a high-voltage pulse and then output a radio frequency current, or first output a radio frequency current and then output a high-voltage pulse.

2. The selectively applicable IRE and RFA hybrid ablation system according to claim 1, characterized in that: It also includes a display module (6) for displaying the voltage and current data collected and processed by the voltage / current measurement unit (21).

3. The selectively applicable IRE and RFA hybrid ablation system according to claim 2, characterized in that: The display module (6) is an oscilloscope.

4. The selectively applicable IRE and RFA hybrid ablation system according to claim 1, characterized in that: The high-voltage pulse unit (31) and the radio-frequency current unit (32) are connected to the output control module (3); the high-voltage pulse unit (31) comprises a voltage regulation control circuit (311) and a MOS tube control circuit (312); and the radio-frequency current unit (32) comprises a radio-frequency voltage control circuit.

5. The selectively applicable IRE and RFA hybrid ablation system according to claim 4, characterized in that: The voltage regulation control circuit is provided with a DC / DC converter, the MOS tube control circuit is a bridge circuit, and the radio frequency voltage control circuit is provided with a DC / AC converter, a high frequency filter and a transformer.

6. The selectively applicable IRE and RFA hybrid ablation system according to claim 1, characterized in that: The voltage / current measurement unit (21), the conductivity measurement unit (22) and the temperature measurement unit (23) all have an acquisition card and an A / D converter; the voltage / current measurement unit (21) comprises a voltage sensor and a current sensor.

7. The selectively applicable IRE and RFA hybrid ablation system according to claim 1, characterized in that: The control module has a PID controller.

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