CN112932652B - Method and device for preventing electric arc from generating in pulsed electric field ablation process - Google Patents
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Abstract
本发明涉及医疗器械技术领域，具体的说是一种防止脉冲电场消融过程中电弧产生的方法。一种防止脉冲电场消融过程中电弧产生的方法，其特征在于：具体方法流程如下：将消融导管放置于指定位置；确定脉冲发生器的输出电压的峰值Upeak；测量输出电流I0；计算导管的贴靠阻抗ZContact；计算不产生电弧时，贴靠阻抗Z0＝ZContact；计算安全冗余贴靠阻抗阈值Zth＝εZ0；计算安全冗余贴靠阻抗阈值Zth所对应的安全冗余电流进行消融，并测量结果为IMeas；在消融时，对IMeas和Ith值的相对大小进行判断，当IMeas＜Ith时，表示即将有电弧产生，此时脉冲控制器控制脉冲发生器终止脉冲发放，即可防止电弧的产生。本发明同现有技术相比，从根源上解决电弧发生的问题，大大增加脉冲电场消融(PFA)的安全性。
The present invention relates to the field of medical device technology, and more specifically, to a method for preventing arc generation during pulsed electric field ablation. A method for preventing arc generation during pulsed electric field ablation, characterized in that: the specific method flow is as follows: placing an ablation catheter at a specified position; determining the peak value Upeak of the output voltage of a pulse generator; measuring the output current I0 ; calculating the contact impedance ZContact of the catheter; calculating that when no arc is generated, the contact impedance Z0 = ZContact; calculating a safety redundant contact impedance threshold Zth = εZ0 ; calculating a safety redundant current corresponding to the safety redundant contact impedance threshold Zth Ablation is performed, and the measurement result is I Meas ; during ablation, the relative size of I Meas and I th is judged. When I Meas < I th , it means that an arc is about to be generated. At this time, the pulse controller controls the pulse generator to terminate the pulse emission, thereby preventing the generation of an arc. Compared with the prior art, the present invention solves the problem of arc generation from the root, greatly increasing the safety of pulsed field ablation (PFA).
Description
Technical Field
The invention relates to the technical field of medical appliances, in particular to a method for preventing electric arcs from being generated in a pulsed electric field ablation process.
Background
In clinical applications of modern medicine, diseases such as tumors and arrhythmia caused by uncontrolled proliferation of cells or ectopic pacing sites in the heart can be treated by pulsed electric field ablation (PFA, pulsed Field Ablation). The main principle is that when the tumor tissue cells or cardiac muscle cells are subjected to the action of external enhanced electric field (the electric field strength is about 100 to 10,000V/cm), the cell membranes are irreversibly electroporated, so that the apoptosis and necrosis are caused, and the cells are cleared by an autoimmune system, thereby achieving the purpose of treatment.
The pulsed electric field ablation method is similar to conventional radiofrequency ablation (RFA, radiofrequency Ablation) in that a dedicated medical electrode catheter is required, and a trained physician inserts the catheter into the patient to reach the lesion to be ablated at the tip of the catheter and release energy to the lesion through the electrode on the catheter. Compared with Radio Frequency Ablation (RFA), the pulsed electric field ablation (PFA) has the advantages that the therapeutic effect is not achieved based on the thermal effect and the thermal damage to the tissues, so that the damage to normal tissues around a target point is not easy to occur when the Radio Frequency Ablation (RFA) is performed, and the occurrence of complications such as esophagus and phrenic nerve damage can be reduced.
In the specific use of pulsed electric field ablation (PFA), it is desirable to maintain a good abutment of the catheter for ablation against the ablated tissue so that the energy is fully released onto the ablated tissue. The manner in which the abutment impedance is measured is often used to determine whether an abutment is good. However, in the ablation process, when an external enhanced electric field is applied to water and ions contained in blood and dissolved gas, electrochemical reaction occurs at the interface between the catheter electrode and blood, so that tiny bubbles are generated on the electrode surface, and the adhesion between the electrode and the tissue to be ablated is deteriorated, while when too many tiny bubbles are generated on the electrode surface, the tiny bubbles are easily broken down by a strong electric field between the discharge electrodes to form an arc. Once an arc is generated near the ablation tissue, the thermal damage on the periphery of the ablation tissue is indicated, and the thermal necrosis of the tissue is easily caused, so that complications are caused.
In the presently disclosed technology, the patent application of the invention such as CN202010662682.8 discloses a heart pulse electric field ablation catheter, which is used for controlling the interval between electrodes, the cross section area of the electrodes and the width of the electrodes of the ablation catheter so as to reduce the generation of electric arcs during high-voltage pulse ablation and avoid safety accidents. Although the invention described above does not involve the core of the pulsed electric field ablating the arc generation, i.e., controlling and/or identifying the generation of tiny bubbles on the electrode surface, by changing the design of the electrode, it fundamentally prevents the generation of arcs.
In view of the above, the art is currently lacking a method and apparatus for preventing arcing between catheter electrodes during pulsed electric field ablation (PFA), which fundamentally solves the problem of arcing, thereby greatly increasing the safety of pulsed electric field ablation (PFA).
Disclosure of Invention
The invention provides a method for preventing electric arc generation in the process of pulse electric field ablation, which solves the problem of electric arc generation from the root and greatly increases the safety of pulse electric field ablation (PFA).
In order to achieve the aim, the method for preventing the generation of the electric arc in the process of pulse electric field ablation is designed and is characterized in that the specific method comprises the following steps:
(1) Placing an ablation catheter at a designated position, and starting a device for preventing electric arcs from generating in the process of pulse electric field ablation;
(2) Determining a peak value U Peak of the output voltage of the pulse generator according to the characteristics of the tissue to be ablated;
(3) Measuring the output current I 0 of the pulse generator;
(4) According to the step (3), calculating the contact impedance Z Contact between the catheter electrode and the tissue;
(5) Calculating the impedance Z 0＝ZContact of the catheter electrode and the tissue when no arc is generated;
(6) Calculating a safety redundancy leaning impedance threshold Z th＝εZ0, wherein a safety redundancy coefficient epsilon (1, 5);
(7) Calculating safe redundant current corresponding to safe redundant leaning impedance threshold Z th
(8) Ablation is carried out, and pulse current is measured in real time through a pulse current detector, wherein the measurement result is I Meas;
(9) During ablation, the relative magnitudes of the values I Meas and I th are judged, when I Meas＜Ith is detected, the arc is about to be generated, and the pulse controller controls the pulse generator to stop pulse emission, so that the arc can be prevented.
The device for preventing the electric arc from generating in the pulse electric field ablation process comprises a pulse generator, a pulse controller, a pulse output switching array, a pulse voltage detector and a pulse current detector, wherein the output end of the pulse controller is respectively connected with the pulse generator and the pulse output switching array, the pulse generator is connected with the pulse output switching array through a circuit, the pulse voltage detector and the pulse current detector are respectively connected on the circuit between the pulse generator and the pulse output switching array, and the signal output end of the pulse voltage detector and the signal output end of the pulse current detector are connected with the signal input end of the pulse controller.
The output end of the pulse controller is connected with the high-voltage power supply module, and the high-voltage power supply module is connected with the pulse generator through a circuit.
The pulse output switching array is connected with the ablation catheter through a circuit.
The pulse output switching array comprises a plurality of relays, one ends of the relays are connected with the pulse generator, and the other ends of the relays are connected with the ablation catheter through connecting cables.
Compared with the prior art, the invention provides a method for preventing the generation of electric arcs in the process of pulse electric field ablation, so that the problem of the generation of the electric arcs is solved from the root, and the safety of pulse electric field ablation (PFA) is greatly improved.
Drawings
FIG. 1 is a block diagram of a system according to the present invention.
Fig. 2 is a schematic diagram of a high voltage power supply module.
Fig. 3 is a schematic diagram of an implementation of a pulse generator.
Fig. 4 is a schematic diagram of an output switching array.
Fig. 5 is a control schematic diagram of the pulse controller.
Fig. 6 is a waveform diagram of a current detecting unit before and after arc generation in the pulsed electric field ablation device according to an embodiment of the present invention.
Fig. 7 is a schematic diagram showing the impedance change between the catheter electrode and the tissue before and after the arc is generated during the pulsed electric field ablation process according to the embodiment of the present invention.
Referring to fig. 1,1 is a high-voltage power supply module, 2 is a pulse generator, 3 is a pulse output switching array, 4 is a pulse controller, 5 is a pulse voltage detector, 6 is a pulse current detector, and 7 is an ablation catheter.
Detailed Description
The invention is further described below with reference to the accompanying drawings.
As shown in fig. 1, the device for preventing electric arc from generating during the process of pulse electric field ablation comprises a pulse generator, a pulse controller, a pulse output switching array, a pulse voltage detector and a pulse current detector, wherein the output end of the pulse controller 4 is respectively connected with the pulse generator 2 and the pulse output switching array 3, the pulse generator 2 is connected with the pulse output switching array 3 through a circuit, the pulse voltage detector 5 and the pulse current detector 6 are respectively connected on the circuit between the pulse generator 2 and the pulse output switching array 3, and the signal output ends of the pulse voltage detector 5 and the pulse current detector 6 are connected with the signal input end of the pulse controller 4.
The output end of the pulse controller 4 is connected with the high-voltage power supply module 1, and the high-voltage power supply module 1 is connected with the pulse generator 2 through a circuit.
The pulse output switching array 3 is connected with the ablation catheter 7 through a line.
The pulse output switching array 3 comprises a plurality of relays, one ends of the relays are connected with the pulse generator 2, and the other ends of the relays are connected with the ablation catheter 7 through connecting cables.
As shown in fig. 2, the high-voltage power supply module 1 includes an AC-DC power supply module, a DC-DC conversion circuit module, and a 220 AC voltage, one end of the AC-DC power supply module is connected to the 220 AC voltage, the other end of the AC-DC power supply module is connected to the DC-DC conversion circuit module, and the DC-DC conversion circuit module is connected to a boost controller inside the pulse controller 4.
The high-voltage power supply module 1 provides high-voltage direct current voltage for the pulse generator 2, the 220V alternating current network power supply outputs 24V low-voltage direct current through the universal AC-DC power supply, and the 24V direct current is boosted to 100-3000V high-voltage direct current through the voltage-adjustable DC-DC conversion circuit and is output to the pulse generator 2.
The pulse generator 2 is used to output unipolar or bipolar electrical pulses. The unipolar electric pulse refers to an electric pulse which does not cross zero and only has a positive half cycle, and the bipolar electric pulse refers to an electric pulse which crosses zero and has a positive half cycle and a negative half cycle, and the pulse amplitudes of the positive half cycle and the negative half cycle can be equal or unequal. As shown in fig. 3, the output power of the high voltage power supply is stored by a capacitor C1, and pulse+ generates a positive voltage with respect to Pulse-when the IGBT switch Q1 is turned on simultaneously with the IGBT switch Q4, and generates a negative voltage with respect to Pulse-when the IGBT switch Q2 is turned on simultaneously with the IGBT switch Q3. The pulse voltage amplitude is approximately equal to the energy storage voltage in the capacitor. Meanwhile, the output voltages of pulse+ and Pulse-are directly subjected to voltage division and attenuation, so that an acquisition signal of the output voltage can be provided for a measurement circuit, and in addition, the output current of the Pulse generator 2 can be obtained by measuring the voltage on the shunt resistor R1. The amplitude of the electric pulse is 100-3000V, the pulse width is 10ns-1000 mu s, the pulse interval is 10ns-1s, and the repetition number is 1-2000.
As shown in fig. 4, the pulse output switching array 3 includes a plurality of relays, one ends of which are connected with the pulse generator 2, and the other ends of which are connected with the ablation catheter 7 through connection cables.
The pulse output switching array 3 is a series of relays whose interfaces are connected to an ablation catheter 7 external to the present invention by a catheter connection cable. As shown in fig. 4, the Pulse generator 2 is connected with the Pulse-and multiplex output electrodes in a manner of a switch matrix before outputting pulses to realize any configuration of the output pulses of the ablation catheter electrode.
As shown in fig. 5, the pulse controller 4 is used to coordinate the operation of the above modules. The main controller in the pulse controller 4 controls the on-off of the high-voltage power supply according to the ablation voltage, controls the IGBT driver to generate the required ablation pulse according to the preset pulse waveform, monitors the pulse voltage and the pulse current at the same time, and judges whether to terminate the discharge in advance according to the relation between the voltage and the current. In addition, the discharge electrode of the ablation catheter 7 is configured by controlling the relay in the pulse output switching array 3, so that the ablation operation is more flexible.
A method for preventing electric arc from generating in the process of pulsed electric field ablation comprises the following specific steps:
(1) Placing an ablation catheter at a designated position, and starting a device for preventing electric arcs from generating in the process of pulse electric field ablation;
(2) Determining a peak value U Peak of the output voltage of the pulse generator according to the characteristics of the tissue to be ablated;
(3) Measuring the output current I 0 of the pulse generator;
(4) According to the step (3), calculating the contact impedance Z Contact between the catheter electrode and the tissue;
(5) Calculating the impedance Z 0＝ZContact of the catheter electrode and the tissue when no arc is generated;
(6) Calculating a safety redundancy leaning impedance threshold Z th＝εZ0, wherein a safety redundancy coefficient epsilon (1, 5);
(7) Calculating safe redundant current corresponding to safe redundant leaning impedance threshold Z th
(8) Ablation is carried out, and pulse current is measured in real time through a pulse current detector, wherein the measurement result is I Meas;
(9) The relative magnitudes of the values of I Meas and I th are determined during ablation, and when I Meas＜Ith indicates that an arc is about to occur, the pulse controller controls the pulse generator to terminate the pulse delivery, thereby preventing the occurrence of an arc.
Embodiment one:
As shown in fig. 6 and 7, in the pulsed electric field ablation device according to an embodiment of the present invention, the current detection unit obtains waveform patterns before and after arc generation. In the figure, I Q is the current before the arc is generated, and I Arc is the current at the time of the arc generation. In actual use, the peak value U Peak of the output voltage of the pulse generator can be measured by the pulse voltage detector to be a constant value for a determined tissue. In the case that the impedance Z Contact between the catheter electrode and the tissue does not change significantly, the magnitude of the discharge current should follow ohm's law, namely:
Before the arc is generated, the impedance Z Contact of the catheter electrode against the tissue can be calculated by the method of fig. 1:
It can be seen that I Arc＞＞I0, the current at which the arc is generated, far exceeds the current at which the arc is not generated. If an attempt is made to calculate the impedance Z Arc at the time of arc generation using equation 1, there are:
However, in the actual ablation process, the impedance change of the internal tissue of the human body is unlikely to be abrupt, and the abutment impedance Z Contact of the catheter and the internal tissue of the human body is unlikely to be abruptly changed to the extent of arcing in a short time. With further reference to the process of changing the current from I 0 to I Arc in fig. 6, it can be seen that the current amplitude is first slowly decreasing and then suddenly increasing sharply when an arc is generated, i.e. there is a slow increase in the abutment impedance Z Contact before the sudden change. It was found by reference that Israel Byrd et al, US 2019/0307500, teaches that apart from the shape of the catheter and electrodes, the spacing between the electrodes and the cross-sectional area of the electrodes, the generation of microbubbles between the electrodes during ablation is another key factor in causing arcing. In combination with the above-described phenomenon that Z Contact had a slowly increasing course prior to mutation, it was found that microbubbles gradually accumulated between the discharge electrodes of the catheter during actual ablation. The foregoing microbubbles have a shop insulating property, and when a large amount is covered on the electrode surface, the effective output area of the electrode becomes small, resulting in an increase in the electrode-myocardial contact impedance Z Contact.
Claims (4)
1. The device for preventing the electric arc from being generated in the pulse electric field ablation process is characterized by comprising a pulse generator, a pulse controller, a pulse output switching array, a pulse voltage detector and a pulse current detector, wherein the output end of the pulse controller (4) is respectively connected with the pulse generator (2) and the pulse output switching array (3), the pulse generator (2) is connected with the pulse output switching array (3) through a circuit, the pulse voltage detector (5) and the pulse current detector (6) are respectively connected on the circuit between the pulse generator (2) and the pulse output switching array (3), and the signal output ends of the pulse voltage detector (5) and the pulse current detector (6) are connected with the signal input end of the pulse controller (4);
The method for preventing the electric arc from generating in the process of pulse electric field ablation comprises the following steps:
step1, placing an ablation catheter at a designated position, and starting a device for preventing electric arcs from being generated in the process of pulse electric field ablation;
step 2, determining a peak value U Peak of the output voltage of the pulse generator according to the characteristics of the tissue to be ablated;
Step 3, measuring the output current I 0 of the pulse generator;
Step 4, according to step 3, calculating the impedance Z Contact of the catheter electrode and the tissue;
Step 5, calculating the impedance Z 0＝ZContact of the catheter electrode and the tissue when no arc is generated;
Step 6, calculating a safety redundancy leaning impedance threshold Z th＝εZ0, wherein a safety redundancy coefficient epsilon (1, 5);
Step 7, calculating a safety redundant current corresponding to the safety redundant leaning impedance threshold Z th
Step 8, ablation is carried out, and pulse current is measured in real time through a pulse current detector, wherein the measurement result is I Meas;
And 9, judging the relative magnitudes of the values I Meas and I th during ablation, and when I Meas＜Ith is detected, indicating that an arc is about to be generated, wherein the pulse controller controls the pulse generator to stop pulse emission, so that the arc can be prevented.
2. The device for preventing electric arc generation during pulsed electric field ablation according to claim 1, wherein the output end of the pulse controller (4) is connected with the high-voltage power supply module (1), and the high-voltage power supply module (1) is connected with the pulse generator (2) through a circuit.
3. The device for preventing electric arc generation during pulsed electric field ablation according to claim 1, wherein the pulsed output switching array (3) is connected to the ablation catheter (7) via a line.
4. A device for preventing arcing during pulsed electric field ablation according to claim 1 or 3, characterized in that the pulsed output switching array (3) comprises a number of relays, one end of which is connected to the pulse generator (2) and the other end of which is connected to the ablation catheter (7) via a connecting cable.
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| CN115414110B (en) * | 2022-09-09 | 2025-07-25 | 剑虎医疗科技(苏州)有限公司 | Impedance-based energy control method and system and pulsed electric field ablation system |
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| CN215018838U (en) * | 2021-04-07 | 2021-12-07 | 上海宏桐实业有限公司 | Device for preventing electric arc from generating in pulsed electric field ablation process |
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| CA2630955C (en) * | 2007-11-15 | 2015-12-29 | Genii, Inc. | Compact electrosurgery apparatuses |
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| WO2015175570A1 (en) * | 2014-05-12 | 2015-11-19 | Virginia Tech Intellectual Properties, Inc. | Selective modulation of intracellular effects of cells using pulsed electric fields |
| CA2981867A1 (en) * | 2015-04-10 | 2016-10-13 | Angiodynamics, Inc. | System and method for irreversible electroporation with thermally controlled electrodes |
| EP3884895B1 (en) * | 2016-11-29 | 2022-10-05 | St. Jude Medical, Cardiology Division, Inc. | Electroporation systems and catheters for electroporation systems |
| EP3749238B1 (en) * | 2018-02-08 | 2023-08-16 | Farapulse, Inc. | Apparatus for controlled delivery of pulsed electric field ablative energy to tissue |
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| JP2000041994A (en) * | 1998-07-30 | 2000-02-15 | Olympus Optical Co Ltd | Electric surgical instrument |
| CN215018838U (en) * | 2021-04-07 | 2021-12-07 | 上海宏桐实业有限公司 | Device for preventing electric arc from generating in pulsed electric field ablation process |
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