CN114533249A

CN114533249A - Self-adaptive follow-up pulse ablation system and method

Info

Publication number: CN114533249A
Application number: CN202210128491.2A
Authority: CN
Inventors: 王昌金; 王小航; 王迎春; 汪超
Original assignee: Chongqing Qianen Medical Technology Co ltd
Current assignee: Chongqing Qianen Medical Technology Co ltd
Priority date: 2022-02-11
Filing date: 2022-02-11
Publication date: 2022-05-27
Anticipated expiration: 2042-02-11
Also published as: CN114533249B

Abstract

The invention provides a self-adaptive follow-up pulse ablation system, which comprises: the system comprises a power supply system, an isolation transformer, a high-voltage power supply, an energy storage system, a pulse generation system, a pulse monitoring system, a pulse switching system, an electrode system, a control system, an isolation system, an acquisition system, a positioning system, a follow-up system, an upper computer system and a cloud platform. The cloud platform and the artificial intelligence algorithm are adopted to provide an optimal treatment parameter range for each treatment process, and pulse (group) parameters are subjected to self-adaptive adjustment in real time in the treatment process, so that the shaking degree and the temperature rise condition of biological tissues are within a threshold range, the relative displacement and the relative rotation of an electrode and a treatment part are reduced, and the optimal treatment effect and the minimum side effect are achieved; meanwhile, the self-adaptive follow-up pulse ablation system and method can reduce the influence of the anisotropy of the biological tissues at the tumor part, so that the pulse ablation is more uniform and the ablation effect is better.

Description

Self-adaptive follow-up pulse ablation system and method

Technical Field

The invention relates to the field of medical equipment, in particular to a self-adaptive follow-up type pulse ablation system and a self-adaptive follow-up type pulse ablation method.

Background

The pulse ablation has attracted wide attention in recent years, and compared with the traditional ablation method, the pulse ablation has the advantages of short treatment time, convenience in treatment, small sequelae, capability of keeping blood vessels and nerves and the like.

In the pulse ablation system of the present day, unipolar pulses are mostly adopted, but the pulse voltage basically exceeds the threshold voltage of muscle contraction, so that the muscle contraction is caused, and the electrode displacement is caused, and the ablation is adversely affected; particularly when applied in the vicinity of the heart, can cause disorders of cardiac contraction with dangerous consequences.

The contraction and shaking of muscles can be reduced by injecting muscle relaxant, but the adoption of the muscle relaxant needs to add extra equipment to maintain the respiration of a treated object, so that the treatment difficulty is increased.

In order to solve the problem that unipolar pulse ablation is easy to cause muscle contraction and jitter, researchers provide a bipolar pulse ablation system, wherein pulses with equal positive pulse energy and negative pulse energy act on biological tissues, and the contraction and jitter of the muscle can be reduced to a certain extent.

However, for biological tissues, the parameters are often anisotropic, and the effects of the same voltage, current, electric field and magnetic field on the anisotropic biological tissues are different; this indicates that the same strength of pulse causes different contraction strength of heart and muscle, so even positive and negative pulses with the same strength cannot be completely cancelled, and also causes contraction and shaking of muscle.

Furthermore, the parameters of the biological tissue are constantly changed during the ablation process, and the existing ablation systems preset the number of ablation pulses and/or pulse groups, which generates a large deviation from the actual ablation progress at the later stage of ablation, so that the treatment cannot achieve the expected effect or generates over-treatment.

How to reduce the influence of jitter and displacement caused by muscle contraction on the pulse ablation to the maximum extent so as to achieve the optimal pulse ablation effect and the minimum side effect is an urgent problem to be solved. Aiming at the problems existing at present, the self-adaptive follow-up pulse ablation system and the self-adaptive follow-up pulse ablation method adopt an artificial intelligence algorithm operated on a cloud platform and a local area, calculate the optimal initialization parameter range for each treatment, simultaneously collect the biological tissue state of a treatment object in the pulse application process and adjust ablation pulse parameters in real time through the artificial intelligence algorithm so as to achieve the optimal ablation effect and the minimum side effect; the displacement and rotation information of the biological tissue of the treatment object is collected and predicted, the electrode is controlled to move along with the biological tissue, the relative displacement of the electrode and the biological tissue is reduced, the treatment effect is improved to the maximum extent, and extra damage is reduced.

Disclosure of Invention

The invention aims to at least solve the technical problems in the prior art, and particularly innovatively provides an adaptive follow-up pulse ablation system and method.

In the system and the method, the parameter range of the ablation pulse is calculated in advance through an artificial intelligence algorithm of a cloud platform, the self-adaptive follow-up type pulse ablation system acquires data such as an electrocardiogram signal, a jitter signal, the temperature condition of biological tissues, the temperature rise condition of the biological tissues, position information, angle information and the like of a treatment object in the ablation process in real time, and the pulse parameters and the position of an electrode are flexibly adjusted in real time through the data, so that the optimal treatment effect and the minimum side effect are achieved.

In order to achieve the purpose, the self-adaptive follow-up pulse ablation system is realized by adopting the following technical scheme:

the self-adaptive follow-up type pulse ablation system mainly comprises a power supply system, an isolation transformer, a high-voltage power supply, an energy storage system, a pulse generation system, a pulse monitoring system, a pulse switching system, an electrode system, a control system, an isolation system, an acquisition system, a positioning system, a follow-up system, an upper computer system and a cloud platform.

The pulse generating system in the set of self-adaptive follow-up pulse ablation system can generate pulses and/or pulse groups with adjustable amplitude, frequency, pulse width, period, interval, number, rising time, falling time, positive polarity and negative polarity, wherein the amplitude of the pulses is between 1 volt and 1 megavolt, the frequency is between 1 millihertz and 1 gigahertz, the pulse width is between 1 nanosecond and 1000 seconds, the period is between 1 nanosecond and 1000 seconds, the interval is between 1 nanosecond and 10000 seconds, and the number is between 1 nanosecond and 1000000000. The pulse generating system can generate unipolar pulses and bipolar pulses, and parameters such as the combination mode, the amplitude, the pulse width, the period, the interval, the number, the rising time and the falling time of the unipolar pulses and the bipolar pulses can be flexibly adjusted in the operation process.

Further, the power supply system is used for directly supplying energy to an upper computer system of the self-adaptive follow-up type pulse ablation system, and supplying energy to the control system, the isolation system and the high-voltage power supply and other subsequent systems through the isolation transformer.

Furthermore, the isolation transformer supplies power to the high-voltage power supply, the energy storage system, the pulse generation system, the pulse monitoring system, the pulse switching system, the electrode system, the acquisition system, the positioning system and the follow-up system, so that the high-voltage power supply, the energy storage system, the pulse generation system, the pulse monitoring system, the pulse switching system, the electrode system, the acquisition system, the positioning system and the follow-up system are separated from the potential of a power grid, and the safety of a treatment object, an operator and the self-adaptive follow-up type pulse ablation system can be effectively guaranteed.

Further, the high-voltage power supply is used for providing the high-voltage and the current required by the pulse generating system, the generated high-voltage is greater than or equal to the maximum voltage required by the pulse generating system, and the current is greater than or equal to the charging current required by the maximum load.

Further, the energy storage system is used for storing energy output by the high-voltage power supply, and then the energy stored for a longer time is released in a shorter time through the pulse generation system so as to form one or more of pulse voltage, pulse current, pulse electric field and pulse magnetic field. The energy storage system comprises a charging resistor, a charging switch, an energy storage element, a charging measurement circuit, an energy storage discharging switch, an energy storage discharging resistor and an energy storage power supply switch, wherein the charging switch and the energy storage power supply switch are normally open switches, and the energy storage discharging switch is a normally closed switch. After the self-adaptive follow-up pulse ablation system is powered on, but the control system does not control signals for the energy storage system, the charging switch and the energy storage power supply switch are disconnected at the moment, and the energy storage discharging switch is closed, so that the situation that energy is not stored on the energy storage element and the energy is not provided for the pulse generation system is ensured. After receiving the corresponding control signal, disconnecting the energy storage discharge switch and closing the charging switch, and charging the energy storage element by the high-voltage power supply through the charging resistor; when the charging measurement circuit detects that the voltage on the energy storage element reaches a set value, the energy storage power supply switch is closed so as to supply power to the pulse generation system; when an emergency condition is sent or the device is powered off, the charging switch and the energy storage power supply switch are disconnected, the energy storage discharging switch is closed, and the energy on the energy storage element is released through the energy storage discharging resistor, so that the safety of a treatment object, an operator and the self-adaptive follow-up type pulse ablation system is ensured.

Furthermore, the pulse generating system is used for transforming and chopping the high-voltage of the high-voltage power supply to form pulses with adjustable output polarity, amplitude, pulse width, period, interval, rise time and fall time. The pulse generating system can receive the control parameters of the control system in real time and respond in real time in the running process, and can meet the requirements of the self-adaptive follow-up pulse ablation system. The pulse generating circuit of the pulse generating system is formed by bridge circuits, and each bridge arm comprises a switching device and a corresponding driving circuit. The switch device is formed by one or more of a semiconductor component, a magnetic switch and a spark switch in series and parallel connection. The pulse generating system also comprises a pulse discharge switch, a pulse discharge resistor and a pulse power supply switch. The pulse discharge switch is preferably a normally closed switch, and the pulse power supply switch is preferably a normally open switch. When the pulse is required to be generated, the pulse discharge switch is disconnected and the pulse power supply switch is closed, and then the pulse is transmitted to a subsequent circuit and a subsequent system by a corresponding control signal of the driving circuit; when emergency or pulse stopping is needed, the pulse power supply switch is disconnected and the pulse discharge switch is closed, so that energy in the pulse generation system is released through the pulse discharge resistor, and safety of a treatment object, an operator and the self-adaptive follow-up pulse ablation system is guaranteed.

Furthermore, the pulse monitoring system is used for monitoring parameters of output pulses, and mainly comprises parameters of one or more of pulse voltage, pulse current, pulse electric field and pulse magnetic field, such as waveform, amplitude, phase, pulse width, interval, period, rise time, fall time, field intensity and the like. For pulse voltage monitoring, a voltage division circuit or an oscilloscope probe is generally adopted for monitoring; for the pulse current, a compass coil or a high-precision resistor connected in series to the circuit is generally used to convert the pulse current into a pulse voltage and then monitor the pulse voltage. By calculating the pulse voltage and the pulse current obtained by monitoring, whether the state of the device is normal or not and whether a predetermined treatment effect is achieved or not can be judged.

Furthermore, the pulse switching system is used for connecting the pulse monitoring system and the electrode system, and can distribute pulses output by the pulse generating system to different electrodes in the electrode system so as to rapidly and flexibly switch the different electrodes during treatment, thereby meeting biological tissues with different sizes, shapes, positions and properties.

Further, the electrode system comprises a plurality of electrodes, and the pulses are output to different electrodes through the pulse switching system in the treatment process, so that the pulses are output to different biological tissues of a treatment object, or the effects of expanding the pulse ablation area and enabling the pulse ablation to be more uniform are achieved through the plurality of electrodes.

Furthermore, the acquisition system comprises devices such as an electrocardiogram module, a jitter acquisition module, an optical fiber temperature sensor, an infrared temperature sensor and the like. The electrocardiogram module is used for measuring heartbeat signals of a treatment object so as to apply pulses in a refractory period of the treatment object, the jitter acquisition module is used for measuring the jitter degree of biological tissues in a treatment process, and the optical fiber temperature measurement sensor and the infrared sensor are used for measuring the temperature and/or temperature rise of the biological tissues in the treatment process, wherein the infrared sensor is mainly used for measuring the temperature and/or temperature rise near the body surface, and the optical fiber temperature measurement sensor is used for measuring the temperature and/or temperature rise in the body.

Furthermore, the positioning system comprises an image acquisition module, and besides the image acquisition module, the positioning system also comprises one or more of a depth of field module, a three-dimensional scanning module, an acceleration module, a speed module and a marker; when the marker exists, the marker is arranged on the biological tissue, so that the position information of the biological tissue can be conveniently acquired; when there is no marker, the characteristic point on the biological tissue can be acquired as the reference point by the image recognition method. The speed module acquires the speed of the biological tissue, and the acceleration module acquires the acceleration of the biological tissue; the depth of field module and the three-dimensional scanning module are used for assisting the image acquisition module to acquire the position information of the biological tissue. The positioning system transmits the information to the control system, the position and the rotation angle to which the biological tissue will move at the next moment are predicted, and the electrode system is controlled to move and/or rotate to the corresponding position and/or angle through the follow-up system so as to reduce the relative displacement and/or relative rotation with the biological tissue.

Furthermore, the follow-up system mainly comprises a multi-degree-of-freedom mechanical arm and a clamping device. The clamping device is used for clamping the electrode system and the electrode of the electrode system, and the mechanical arm controls the electrode system and the electrode to move and rotate along with the biological tissue after the operation and prediction of the control system according to the data provided by the positioning system, so that the relative displacement and the relative rotation angle of the electrode relative to the biological tissue are minimum.

Further, the main Chip of the control System is composed of a Field Programmable Gate Array (FPGA), an Application Specific Integrated Circuit (ASIC), a Complex Programmable Logic Device (CPLD), a Microcontroller (MCU), a Digital Signal Processor (DSP), an ARM, a System On Chip (SoC), a Central Processing Unit (CPU), a Graphics Processing Unit (GPU), an STM32, a GD32, a single Chip, and other chips, and further includes necessary power management chips, Digital-to-analog conversion chips, analog-to-Digital conversion chips, communication chips, read-only memories, random access memories, super capacitors, and the like.

Further, the control system is used for receiving a control command of the upper computer system to control the system, including but not limited to a power supply system, a high-voltage power supply, an energy storage system, a pulse generation system, a pulse monitoring system, a pulse switching system, an electrode system, an acquisition system, a positioning system and a follow-up system; collecting the waveform, amplitude, phase, pulse width, period, interval and field intensity data of pulse voltage, pulse current, pulse electric field and pulse magnetic field of a pulse monitoring system, electrocardiogram signals, jitter information, temperature information and temperature rise information of the collection system, position information and angle information of a positioning system, input and output information of a high-voltage power supply, states of various switches and energy storage elements of an energy storage system, information of various switch states of a pulse generation system and the like; and communicates with an upper computer system and then transmits the data to the upper computer system for calculation, storage, display, forwarding and other purposes. When the self-adaptive follow-up type pulse ablation system is powered off accidentally, the energy on the super capacitor is enough to ensure the normal shutdown of the whole system and the safe release of the stored energy in the self-adaptive follow-up type pulse ablation system.

Further, the upper computer system is used for inputting information of the treatment object, including basic information and information of a treatment part of the treatment object, and then transmitting the information to the cloud platform, the cloud platform generates a corresponding treatment parameter range according to the past treatment object condition, treatment parameters, treatment effects and postoperative feedback through an artificial intelligence algorithm, and the treatment parameter range comprises data such as a pulse form, a pulse amplitude range, a pulse number range, a pulse width range, a pulse delay range, a pulse period range, a rise time range and a fall time range. Medical personnel or operating personnel can adopt the parameters provided by the cloud platform, can also adjust the parameters, and after the parameters are set, the parameters are transmitted to the control system through the isolation system. The upper computer system is also responsible for receiving the data provided by the control system, and carrying out calculation, storage, display and forwarding.

Further, the isolation system is used for isolating the high-voltage part from the low-voltage part, so that the high-voltage part is ensured not to interfere with the low-voltage part and the control system, and the safety of a treatment object, an operator and the self-adaptive follow-up type pulse ablation system is ensured.

Further, the self-adaptive follow-up pulse ablation method mainly comprises the following steps: in the pulse output process, the ratio of the positive pulse energy to the negative pulse energy is adjusted in real time and in a self-adaptive manner, so that the shaking degree of the biological tissue is in a threshold range; in the pulse output process, the positive pulse energy, the negative pulse energy and/or the output speed of the pulse are adjusted in real time and in a self-adaptive manner in equal proportion, so that the temperature rise of the biological tissue is controlled within a threshold range; in the treatment process, the position and the angle of the electrode are adjusted in real time through a follow-up system, and the displacement of the electrode in the electrode system relative to the biological tissue is reduced to be within a threshold range; calculating whether one or more parameters of impedance, capacitive reactance and inductive reactance of the biological tissue meet the treatment ending condition through an artificial intelligence algorithm by acquiring one or more parameters of waveform, amplitude, phase, pulse width, period, interval and field intensity of one or more of pulse voltage, pulse current, pulse magnetic field and pulse electric field applied to the biological tissue; the output of the pulse is ended when the end treatment condition is satisfied, or whether to end the pulse output is decided by the operator at any time.

Further, the method for adjusting the ratio of the positive pulse energy to the negative pulse energy is as follows: acquiring jittering acceleration information and/or jittering displacement information of the biological tissue in the application process of each pulse (group) and/or within a specific time length after the pulse (group) is applied, and calculating the amplitude and/or average value of the acceleration information and/or the displacement information as an evaluation parameter of the biological tissue jittering; changing the positive pulse energy and/or the negative pulse energy by adjusting one or more parameters of the pulse width, the amplitude, the rising time and the falling time of the pulse; at the initial moment, applying positive pulse (group) and negative pulse (group) with equal energy, recording the jitter degree, if the jitter degree is larger than the set threshold, changing the ratio of the positive pulse energy to the negative pulse energy, judging whether the jitter degree is reduced, if so, indicating that the adjusting direction is correct, and continuing to adjust along the direction until the threshold requirement is met; if the jitter degree is not reduced, the ratio of the positive pulse energy and the negative pulse energy is adjusted according to the reverse direction; the ratio of the positive pulse energy to the negative pulse energy is adjusted in this manner until the degree of jitter is reduced to within the threshold range.

Further, the method for proportionally adjusting the output speed of the positive pulse energy and the negative pulse energy and/or the pulse is as follows: acquiring whether the temperature and/or temperature rise of the biological tissue is within a set threshold range in the pulse application process, and if so, maintaining the current positive pulse energy and negative pulse energy and/or output speed thereof; if the temperature and/or the temperature rise exceed the set threshold value, under the condition of keeping the ratio of the energy of the positive pulse to the energy of the negative pulse unchanged, the values of the energy of the positive pulse and the energy of the negative pulse are reduced in an equal proportion, and/or the output speed of the positive pulse and the negative pulse is reduced, so that the temperature and/or the temperature rise of the biological tissue is controlled within the threshold value range.

Further, the method for adjusting the position and the angle of the electrode comprises the following steps: acquiring current position and/or angle information of the biological tissue and/or calculating and/or predicting displacement information and/or rotation information of the biological tissue by combining jitter information in an acquisition system through one or more devices and/or methods of a displacement sensor, image recognition and three-dimensional scanning; then driving a follow-up system to control the electrode system to move and/or rotate according to the predicted position; and correcting the prediction algorithm and parameters thereof according to the difference between the prediction result and the actual movement and/or rotation result of the biological tissue, so that the prediction result is optimal.

Further, t is predicted_nAt the moment the position P to which the biological tissue is to be moved_nThe coordinates of (c) can be calculated using the following formula:

in the formula, the subscript n should satisfy the constraint condition, P, labeled after the formula_n-1、P_n-2、P_n-3Are each t_n-1、t_n-2、t_n-3Coordinates of the position of the biological tissue at the moment, v is the velocity measured by the velocity module, a is the acceleration measured by the acceleration module, and Δ t is the time interval between two sampling moments. The time intervals Δ t may be unequal when the speed and/or acceleration of the biological tissue is acquired by the speed module and/or the acceleration module. In the absence of a speed module and an acceleration module, the method is realized by sampling images at equal intervalsIn the calculation, the time intervals Δ t are equal; when the speed module and the acceleration module are not provided, and the calculation is carried out through image sampling, if the time intervals are not equal, the calculation can also be carried out after normalization processing.

The formula can be applied to one-dimensional motion, two-dimensional motion and three-dimensional motion, when the formula is applied to the two-dimensional motion and the three-dimensional motion, the position coordinates of the corresponding direction can be calculated according to the x direction, the y direction and the z direction respectively according to the actual situation, and then the vector operation is carried out; or transforming to other coordinate systems through coordinates, and then calculating according to corresponding calculation rules, which is not described in detail herein.

Further, after the two-dimensional position and the three-dimensional position of the biological tissue are predicted by the above formula, t can be predicted_nThe angle of rotation of the biological tissue at that moment.

When the two-dimensional rotation angle of the biological tissue is predicted, the positions of two non-coincident points on the biological tissue are predicted, then the normal vector of the straight line formed by the two points is calculated according to the positions of the two points obtained by prediction, and the included angle between the normal vector and the normal vector of the straight line formed by the two points at the previous moment is the rotation angle of the biological tissue in the two-dimensional plane.

When the three-dimensional rotation angle of the biological tissue is predicted, the positions of three points which are not on the same straight line on the biological tissue are predicted, then the normal vector of a plane formed by the three points is calculated according to the positions of the three points obtained by prediction, and the included angle between the normal vector and the normal vector of the plane formed by the three points at the previous moment is the rotation angle of the biological tissue in the three-dimensional plane.

After the position and the rotation angle of the biological tissue are predicted, the electrode system and the electrode can be controlled to move along with the biological tissue through the mechanical arm, so that the relative displacement and the angle difference of the electrode relative to the biological tissue are reduced, and the influence on normal tissue during ablation is reduced.

In summary, compared with the prior art, the invention has the following advantages:

1. the cloud platform and the artificial intelligence algorithm are adopted to provide an optimal treatment parameter range for each treatment process, and pulse parameters are adjusted in a self-adaptive manner in real time in the treatment process, so that the shaking degree and the temperature rise of the biological tissue are within a threshold range, and the optimal treatment effect and the minimum side effect are achieved; meanwhile, the self-adaptive follow-up pulse ablation system and method can reduce the influence of the anisotropy of the biological tissues at the tumor part, so that the pulse ablation is more uniform and the ablation effect is better.

2. The self-adaptive adjustment algorithm is adopted to predict the position and the angle of the biological tissue to be moved, the electrode system and the electrode are enabled to move and rotate along with the biological tissue under the control of the follow-up system, the relative displacement and the angle of the electrode and the biological tissue are reduced, the pulse application position is enabled to be more accurate, and the influence on the normal tissue is reduced to the maximum extent.

3. The electrode array is arranged, so that ablation on large-size and irregularly-shaped biological tissues is more convenient and flexible.

4. The safety protection system of hardware levels such as a normally open switch, a normally closed switch, an energy release circuit and the like is reasonably adopted, so that the safety of a treatment object, an operator and the self-adaptive follow-up type pulse ablation system can be effectively ensured.

Additional aspects and advantages of the invention will be set forth in part in the description which follows and, in part, will be obvious from the description, or may be learned by practice of the invention.

Drawings

The above and/or additional aspects and advantages of the present invention will become apparent and readily appreciated from the following description of the embodiments, taken in conjunction with the accompanying drawings of which:

fig. 1 is a block diagram of an adaptive follow-up pulse ablation system according to the present invention.

Fig. 2 is a schematic diagram of a follow-up system in the adaptive follow-up pulse ablation system of the present invention.

FIG. 3 is a flow chart of the follow-up system of the present invention following the movement and rotation of biological tissue under the prediction of an artificial intelligence algorithm.

FIG. 4 is a diagram illustrating a method for predicting line segment translation and rotation angles in a two-dimensional space according to the present invention.

FIG. 5 is a schematic diagram of the method for predicting plane translation and rotation angles in a three-dimensional space according to the present invention.

Fig. 6 is a flow chart of the present invention for adaptively adjusting pulse parameters.

Fig. 7 is a schematic diagram of a method for adjusting the energy of the positive pulse and/or the energy of the negative pulse by changing the pulse width of the pulse.

FIG. 8 is a schematic diagram of a method for adjusting the energy of a positive pulse and/or the energy of a negative pulse by varying the amplitude of the pulse.

FIG. 9 is a schematic diagram of a method for adjusting the energy of a positive pulse and/or the energy of a negative pulse by varying the pulse width and/or amplitude of the pulse.

Fig. 10 is a schematic diagram of a method of adjusting the energy of a positive pulse and/or the energy of a negative pulse by varying the rise time and/or the fall time of the pulse.

FIG. 11 is a schematic diagram of the present invention for adjusting the positive pulse energy and/or negative pulse energy ratio.

Fig. 12 is a schematic diagram of the connection of the power supply system, isolation transformer and high voltage power supply of the present invention.

Fig. 13 is a schematic of the energy storage system of the present invention.

Fig. 14 is a schematic diagram of a pulse generation system of the present invention.

Fig. 15 is a schematic diagram of a pulse monitoring system of the present invention.

Fig. 16 is a schematic diagram of a pulse switching system of the present invention.

Detailed Description

Reference will now be made in detail to embodiments of the present invention, examples of which are illustrated in the accompanying drawings, wherein like or similar reference numerals refer to the same or similar elements or elements having the same or similar function throughout. The embodiments described below with reference to the accompanying drawings are illustrative only for the purpose of explaining the present invention, and are not to be construed as limiting the present invention.

The invention provides a self-adaptive follow-up type pulse ablation system, which can be applied to biological tissues to perform pulse ablation. As shown in fig. 1, the system comprises a power supply system, an isolation transformer, a high-voltage power supply, an energy storage system, a pulse generation system, a pulse monitoring system, a pulse switching system, an electrode system, a follow-up system, an acquisition system, a positioning system, a control system, an isolation system, an upper computer system and a cloud platform. The power supply system directly supplies power to the upper computer system and supplies power to other subsequent systems through the isolation transformer. The high-voltage power supply is connected to the other side of the isolation transformer and converts alternating current into high-voltage direct current, and the high-voltage direct current is connected into an energy storage system. The energy storage system stores the energy of the high-voltage power supply and provides energy for the pulse generation system, and the pulse generated by the pulse generation system is fed back to the control system by monitoring various data of pulse voltage and current through the pulse monitoring system. The pulse switching system switches the output pulses to be output to different electrodes of the electrode system and to act on the treatment object. The acquisition system acquires an electrocardiogram signal, jitter information, temperature rise condition and displacement condition of a treatment object of biological tissues and transmits the electrocardiogram signal, the jitter information, the temperature rise condition and the displacement condition to the control system for use. The positioning system acquires information such as position, velocity, acceleration, etc. of the biological tissue. The follow-up system makes the electrode system move along with the treatment object under the control of the control system. The isolation system isolates high voltage and control voltage in the system, and ensures the safety of a treatment object, an operator and the self-adaptive follow-up type pulse ablation system. The upper computer system is used for receiving input of an operator, transmitting data to the cloud platform and providing control signals for the control system. The self-adaptive follow-up pulse ablation system can flexibly adjust the pulse energy and the ratio of the positive pulse energy to the negative pulse energy of the pulse and control the electrode system to automatically follow the movement of the biological tissue, and can realize the optimal pulse ablation effect and the lowest side effect.

A follow-up system in the self-adaptive follow-up type pulse ablation system is shown in fig. 2, and the follow-up system comprises a multi-degree-of-freedom mechanical arm and a clamping device; the clamping device is arranged on the multi-degree-of-freedom mechanical arm and clamps the electrode system; the multi-degree-of-freedom mechanical arm receives a control signal of the control system to adjust the position and the angle of the electrode in real time, and reduces the displacement of the electrode in the electrode system relative to the biological tissue to be within a threshold range; so that the follow-up system, under the control of the control system, moves the electrode system to follow the treatment object.

The following steps of the following biological tissue moving and rotating by the following system under the prediction of the artificial intelligence algorithm are shown in FIG. 3:

s100, starting;

s200, a positioning system acquires the position information of a marker of a treatment part of a treatment object;

s300, predicting the treatment track of the treatment object by adopting an AI system;

s400, driving a follow-up system to enable the electrode needle to move along with the prediction result;

s500, judging whether other systems and modules send signals for stopping treatment or not, and if so, executing the step S800; if not, executing the next step;

s600, judging whether the error between the prediction result and the actual result of the previous round of AI is smaller than a threshold value, if so, executing the step S200; if not, executing the next step;

s700, adjusting parameters of an AI prediction system to perform next prediction, and then executing the step S200;

and S800, ending.

First embodiment

Firstly, medical care personnel or operating personnel collect data of a treatment object including but not limited to sex, age and tolerance of the treatment object, record the shape, size, position and type of a treatment part of the treatment object, input the information through an upper computer system, the upper computer system transmits data to a cloud platform after receiving the information, the cloud platform adopts an artificial intelligence algorithm to combine the condition, treatment parameters, treatment effect and postoperative feedback of the treatment object in the past to give an optimal parameter range of the treatment, and then transmits the parameter range to the upper computer system, and the medical care personnel or the operating personnel can adjust the parameters according to the actual condition of the treatment.

After the medical staff or the operating staff checks or adjusts the parameters, the system can carry out self-checking before formal treatment, mainly comprises the detection of a high-voltage power supply, the detection of an energy storage system, the detection of a pulse generation system, the detection of a pulse switching circuit, the detection of a follow-up system and the like, and after the detection of the detection, the operating staff is prompted to insert the electrode into the treatment part of the treatment object for treatment.

The medical staff or the operator inserts the electrode into the biological tissue under the guidance of equipment such as nuclear magnetic resonance, ultrasound or CT according to the calculated electrode distance and position.

After the electrode is inserted into the biological tissue, firstly, a pulse voltage with lower amplitude (about tens of volts) is generated by a pulse generation system, and then the waveforms of the pulse voltage and the pulse current are measured, and the data such as the amplitudes and the waveforms of the pulse voltage and the pulse current are compared to determine whether the data are in an expected range. If the pulse current amplitude is too large, the situation that the electrode is too close to the electrode or short circuit exists is described; if the pulse current is too small, it indicates that there may be a case where the insulating layer of the electrode is not provided to an appropriate length, or the electrode is not inserted or even broken. No matter what abnormal condition is, the medical staff is prompted to check, and the operation is carried out again after the check is finished.

The acquisition system acquires an electrocardiogram signal of a treatment object, jitter information of the treatment object, temperature (temperature rise) of biological tissues and an infrared image of the biological tissues; the positioning system acquires information such as position, speed, acceleration and the like of biological tissues; the information is input into the control system through the isolation system, and the control system is used for calculating the pulse output time and the pulse output parameters and controlling the follow-up system to move and rotate after receiving the information.

In order to reduce the influence of the pulse on the shaking degree of the biological tissue and the heartbeat signal of the treated object to the maximum extent, the pulse is required to be output in a refractory period after the electrocardiogram signal, so that the shaking degree of the biological tissue is reduced on the whole. However, even if the pulse is applied in the refractory period of the cardiac signal, the influence of the pulse on the muscle contraction and the heartbeat signal can be reduced only to a certain extent, and when the influence of the pulse needs to be further reduced, the pulse is further reduced by means of adaptive adjustment of pulse parameters.

The minimum jitter degree of the biological tissue is controlled as an adjusting target, the jitter degree of the biological tissue can be used as an input parameter, and the ratio of the positive pulse energy to the negative pulse energy is used as an adjusting parameter; the temperature and/or temperature rise measured by an infrared temperature measurement system or an optical fiber temperature measurement system can be used as input parameters, and one or more of the sum of positive pulse energy and negative pulse energy and the output speed of the pulse can be used as adjusting parameters.

In a refractory period when a heartbeat electrocardiogram signal is received, controlling a pulse generating system to apply a positive polarity pulse (group) and a negative polarity pulse (group) with equal energy, and recording the shaking degree of the biological tissue at the moment; then, a pulse group with the positive pulse intensity larger than the negative pulse intensity is applied, and the jitter degree of the biological tissue at the moment is recorded. If the jitter degree of the biological tissue after the output of the second pulse group is larger than the jitter degree after the output of the first pulse group, the adjustment direction is wrong, a pulse (group) with positive pulse energy smaller than negative pulse energy needs to be applied, after the pulse group is applied, the jitter degree of the biological tissue at the moment is recorded, if the jitter degree of the biological tissue is reduced, the adjustment direction is correct, and then the adjustment is continued according to the direction until the jitter degree of the biological tissue is smaller than the set threshold value. Conversely, a parameter between the second burst and the third burst, and so on.

The shaking degree of the biological tissue is acquired, and then the shaking of the biological tissue can be reduced by adjusting the proportion of the positive pulse energy and/or the negative pulse energy. However, the movement of the biological tissue caused by the shaking is accumulated and then is greatly displaced and/or rotated, and if the electrode needle does not move and rotate along with the biological tissue, the electrode is easily displaced, so that the treatment effect is poor and even the normal tissue is damaged. Therefore, the positioning system is required to acquire the displacement and rotation of the biological tissue in the three-dimensional space, predict the position to which the biological tissue is to move and the rotation of the rotation through an artificial intelligence algorithm, and drive the electrodes clamped by the follow-up system to follow the movement and/or rotation of the biological tissue. Preferably, the positioning system comprises an image acquisition module, a depth of field module, a three-dimensional scanning module, an acceleration module, a speed module, a marker and the like. The data obtained is then transmitted to a control system to predict the translation and rotation information of the biological tissue.

The method for predicting the displacement and rotation of biological tissue in two-dimensional space is described below with reference to fig. 4:

at t₁A point A in the space on the biological tissue is acquired by an image acquisition module and other equipment at any moment₁Position, A₁Has the coordinates of (x)_A1,y_A1) B point on biological tissue is located in B in space₁Position, B₁Has the coordinates of (x)_B1,y_B1). If a speed module and an acceleration module are provided, point A is predicted to be at t through the following formula₂Position A after the moment of time shift₂(x_A2,y_A2)：

x_A2＝x_A1+v_x△t+0.5a_x△t²

y_A2＝y_A1+v_y△t+0.5a_y△t²

In the formula, v_xThe component of the speed v in the direction of the x axis, a, acquired by the speed module_xAcquiring the component of the acceleration a in the x-axis direction for the acceleration module; v. of_yComponent of velocity v in y-axis direction, a, acquired by velocity module_yAnd acquiring the component of the acceleration a in the direction of the v axis for the acceleration module.

Similarly, predict point B at t₂Position B after the moment of time shift₂Has the coordinates of (x)_B2,y_B2) As shown in the following equation:

x_B2＝x_B1+v_x△t+0.5a_x△t²

y_B2＝y_B1+v_y△t+0.5a_y△t²

two points are obtained in the prediction at t₂After the coordinates of the time, two points A on the biological tissue can be adopted₁、B₁One point W on the line segment₁Coordinates of points (λ x)_A1+(1-λ)x_B1,λy_A1+(1-λ)y_B1) And W after movement₂Point coordinates (λ x)_A2+(1-λ)x_B2,λy_A2+(1-λ)y_B2) Wherein 0 ≦ λ ≦ 1, to represent the overall displacement situation on the biological tissue. Namely W₂Point coordinate minus W₁The coordinates of the points represent the displacement of the entire biological tissue. In the above expression, λ is generally 0.5, but other values may be used for calculation because of the anisotropy of the biological tissue, and the coefficient λ may be corrected by an artificial intelligence algorithm according to the deviation between the prediction result and the actual value at the next time in the operation process; when λ is 0 or 1, it represents the displacement of the whole biological tissue represented by point B or point a, which is also possible in some special cases.

How to predict the rotation of the biological tissue by the predicted coordinates and the over-displacement condition will be explained below.

Two points A on the biological tissue before movement₁、B₁The direction vector of the connecting line of (a) is (x)_B1-x_A1,y_B1-y_A1) Then its normal vector is

Similarly, the two points A on the moved biological tissue₂、B₂The direction vector of the connecting line of (a) is (x)_B2-x_A2,y_B2-y_A2) Normal vector is

The rotation angle θ of the two normal vectors before and after the movement can be expressed as the following formula:

in the formula, the molecule

Representing a vector

(Vector)

The product of quantity of (1), denominator

Representing a vector

Modulo and vector of

The product of the modes of (a).

For the case of only one point, the displacement of the biological tissue can be predicted by the above steps.

The above embodiment is to predict the displacement and/or rotation of the biological tissue through two points of the biological tissue in the presence of the velocity module and the acceleration module, and the following explains that the displacement and/or rotation of the biological tissue in three-dimensional space is predicted through three points on the biological tissue in the absence of the velocity module and the acceleration module.

As shown in fig. 5, plane S₁Is t₁Three points C on the biological tissue at different times₁(x_C1,y_C1,z_C1)、D₁(x_D1,y_D1,z_D1)、E₁(x_E1,y_E1,z_E1) The plane of the structure is formed by the two layers,

is S₁A normal vector of the plane; plane S₂Is t after a time length of delta t₂Time C₁，D₁，E₁The point moves to three points C which are not on a straight line₂(x_C2,y_C2,z_C2)，D₂(x_D2,y_D2,z_D2)，E₂(x_E2,y_E2,z_E2) The plane formed by the back of the plate is,

is S₂A normal vector of the plane; plane S₃Is t after a time length of delta t₃The three points are moved to three points C which are not on a straight line₃(x_C3,y_C3,z_C3)，D₃(x_D3,y_D3,z_D3)，E₃(x_E3,y_E3,z_E3) The plane formed by the back of the plate body,

is S₃The normal vector of the plane.

By t after a duration of Δ t₄At the moment, the three points move to three points C which are not on a straight line₄，D₄，E₄Plane S formed after₄Then predict t₄Time C₄The coordinates of the point are (x)_C4,y_C4,z_C4) The following formula can be used for calculation:

in a similar manner, at t₄Time of day, prediction D₄And E₄The coordinates of (c) can also be calculated as (x) by the above-mentioned method_D4,y_D4,z_D4)、(x_E4,y_E4,z_E4) And will not be described herein.

t₃Time C₃，D₃，E₃Formed plane S₃Normal vector of (1)

Comprises the following steps:

in the formula

The unit vectors are in the x, y, and z directions, respectively.

When predicted t₄Time C₄、D₄、E₄Coordinate (x) of_C4,y_C4,z_C4)、(x_D4,y_D4,z_D4)、(x_E4,y_E4,z_E4) Then t can be calculated₄Time plane S₄Normal vector of (1)

Comprises the following steps:

the rotation angle theta is expressed according to the predicted direction vectors of the two points_t43The following formula can be used for calculation:

in the formula, the molecule

Representing a vector

(Vector)

The product of quantity of (1), denominator

Representing a vector

Modulo and vector of

The product of the modes of (a).

Besides, the three-dimensional vectors can be projected to coordinate axis planes xy, yz and zx, and then the rotation angles of the corresponding vectors on the coordinate axis planes can be calculated respectively. Besides mapping to plane coordinates, the coordinate system can also be transformed to other coordinate systems, which are not described in detail here.

Predicting the overall displacement of the biological tissue, which can be based on S₄And S₃The center of gravity of a triangle formed by three points on the plane is calculated. In practical situations, because of the anisotropy of biological tissues, the displacement and rotation of each point are different, different weights can be given to the three points for calculation, and the weight coefficients can be corrected according to the prediction result and the practical result by adopting an artificial intelligence algorithm.

In the above explanation, two points and three points on the biological tissue are taken into consideration as a whole, and a comprehensive prediction can be performed using a plurality of points on the biological tissue, and even a plurality of points are independently predicted and used to control a plurality of mechanical arms to move and rotate a plurality of electrodes, so that the relative displacement and relative rotation of the electrode system and the electrodes with respect to the biological tissue are minimized. These should be considered within the scope of the present invention and are not described in detail herein.

In the above explanation, the case of simultaneously having the speed sensor and the acceleration sensor, or not having the speed sensor and the acceleration sensor, is described, but a person skilled in the art can derive the prediction method in the case of having one speed sensor or one acceleration sensor according to the above, which should be within the protection scope of the present invention, and the description is omitted here.

After the jitter degree of the biological tissue is stabilized within the set threshold range or in the process of controlling the jitter degree of the biological tissue to be stabilized within the set threshold range, whether the temperature rise of the biological tissue is also within the threshold range needs to be detected, and if the temperature exceeds the set threshold range, the positive pulse energy and the negative pulse energy are proportionally reduced and/or the output speed of the pulse (group) is reduced, so that the temperature rise is within the threshold range.

The electrical parameters of the tumor part are changed along with the pulse ablation, the change of the impedance of the ablation part is calculated through the pulse voltage and the pulse current which are acquired in real time, when the impedance is smaller than a set value, the pulse ablation is finished, the pulse output can be stopped, the treatment can be stopped, and the treatment can also be stopped after the specified number of pulses is reached.

The first embodiment introduces the method of the present invention for adaptively adjusting the pulse parameters and the follow-up. The following is a second embodiment of the present invention.

As shown in FIG. 12, the power supply system of the present invention uses a power supply range of 100-240V-50/60 Hz, which is suitable for most countries and regions in the world. The power supply system comprises a fuse, a switch, a filter and a grounding system. The parameter selection of the fuse is selected according to the voltage and the load of power supply, the switch is used for controlling whether the power supply is supplied to the self-adaptive follow-up type pulse ablation system, and the filter is used for filtering out harmonic waves in the power supply.

The isolation transformer of the invention is used for isolating the power supply system from the power supply of the pulse generation part. The isolation voltage strength is larger than the amplitude of the output maximum pulse voltage, and the power requirement under the condition of the maximum load is met.

The high-voltage power supply is used for outputting high-voltage direct current, and has a protection function and a remote control function, and the output voltage and current magnitude meet the requirements of a pulse generation system. Aiming at a high-voltage power supply for conventional ablation, the output voltage range can be 0-10 kV, and the output current range is 0-100 mA. The high-voltage power supply is controlled by adopting a Modbus protocol, and the adjustment precision of the high-voltage power supply with the maximum output voltage of 10kV is 1V.

As shown in fig. 13, the energy storage system includes a charging resistor, a charging switch, an energy storage element, a charging measurement circuit, an energy storage discharging switch, an energy storage discharging resistor, and an energy storage power supply switch. The charging switch and the energy storage power supply switch are preferably normally open switches, and the energy storage discharging switch is preferably a normally closed switch. For the charging switch, the energy storage discharging switch and the energy storage power supply switch, the withstand voltages of the charging switch, the energy storage discharging switch and the energy storage power supply switch are all larger than the maximum output voltage of the high-voltage power supply and the maximum voltage of the pulse generating circuit. For the charging switch, its current capacity should be greater than the maximum charging current; for the discharge switch, the current capacity of the discharge switch is larger than the maximum discharge current of the system; for the power supply switch, its current capacity should be greater than the maximum pulse current of the system.

The energy storage element is a core element in the energy storage system, and may be composed of one or more elements of a capacitor, an inductor, and a resistor. Preferably, the capacitor constitutes the energy storage element, and may be constituted by a single capacitor, or may be constituted by a plurality of capacitors connected in series or in parallel. The energy storage element needs to ensure that the voltage drop of the pulse is smaller than a set percentage value when the maximum pulse width, the maximum voltage amplitude and the minimum impedance are generated. Generally speaking, the pulse is applied to follow the electrocardiogram signal of the heart, and for the human body, the heartbeat can be taken as 1 second/time, the sum of the pulse widths of all the positive pulses and the negative pulses in the 1 second time can be calculated according to 1 millisecond, that is, the equivalent pulse width is taken as 1 millisecond, because the pulse output time is far shorter than the heartbeat interval time, the influence of the high-voltage power supply on charging the energy storage capacitor in the time period can be avoided, the impedance of the biological tissue is generally 100 ohms, and the voltage drop is generally required to be less than 5% of the voltage amplitude, in the case of the voltage drop, the formula can be used: the capacity of the energy storage capacitor (pulse width or equivalent pulse width multiplied by voltage) ÷ (voltage drop multiplied by impedance) in one cycle period is approximately calculated, the capacity of the energy storage capacitor obtained through calculation needs to be larger than 200 microfarads, and the capacity of the energy storage capacitor can be 300 microfarads in consideration of a certain margin.

As shown in fig. 14, the pulse generation system includes a pulse generation circuit, a pulse discharge switch, a pulse discharge resistor, and a pulse power supply switch. The pulse discharge resistor and the pulse discharge switch are connected in series and then connected in parallel at the output end of the bridge circuit, and the pulse power supply switch is connected in series in the discharge loop. The switch device on each bridge arm of the bridge circuit can be formed by semiconductor components, magnetic switches, spark switches and other switches or series-parallel combination of the semiconductor components, the magnetic switches and the spark switches. The bridge circuit has 4 sets of switching devices S1, S2, S3, S4 and their driving circuits drive 1, drive 2, drive 3, drive 4. And when the driving circuit receives a control signal of the control system, the corresponding switch is driven to be switched on or switched off. When S1 and S4 are turned on, a positive pulse is pulse-output (pulse output terminal a is opposite to pulse output terminal B); when S2 and S3 are turned on, a negative pulse is output (pulse output a terminal with respect to pulse output B terminal). When the biological tissue needs to be provided with the pulse, the pulse power supply switch is closed, and the pulse discharge switch is opened. When it is desired to temporarily stop pulsing the biological tissue, the pulsed power switch is turned off. When emergency occurs, the pulse power supply switch is switched off and the pulse discharge switch is switched on, so that the energy in the pulse generation system is released through the pulse discharge resistor, and the safety of a treatment object, an operator and the self-adaptive follow-up pulse ablation system is ensured. The pulse output end of the pulse generating system is connected to the pulse monitoring system through a lead.

As shown in fig. 15, the pulse monitoring system is used to monitor parameters such as output pulse voltage, amplitude, phase, pulse width, period, interval and waveform of pulse current. The output pulse voltage can be monitored after the voltage of the output pulse is reduced by adopting an oscilloscope probe or a voltage divider and the like; the output pulse current can be measured by passing the pulse voltage through a high precision resistor with a small resistance value or through a Rogowski coil. A generally preferred solution is to use an oscilloscope probe and a rogowski coil for the measurement. The oscilloscope probe is required to firstly meet the condition that the maximum measurement voltage is larger than the amplitude of the maximum pulse voltage provided by the pulse generating system, and the bandwidth is larger than the bandwidth of the pulse. The Rogowski coil is adopted to firstly meet the requirements that the maximum measurement current of the Rogowski coil is larger than the amplitude of the maximum pulse current provided by a pulse generation system, and the bandwidth of the Rogowski coil is larger than the bandwidth of a pulse.

As shown in fig. 16, the pulse switching system is generally configured by using a semiconductor switching device or a relay. When the semiconductor switch devices are selected, each switching unit may be formed by combining a plurality of semiconductor switch devices in series and parallel; the circuit structure of the selected relay is relatively simple, and generally, the relay is preferably adopted. The withstand voltage value of the selected relay needs to be larger than or equal to the amplitude of the maximum pulse voltage, and the through-current capacity of the relay needs to be larger than or equal to the amplitude of the maximum pulse current. The number of relays in the pulse switching system is generally even, in this embodiment, 8 single-pole double-throw relays and output control relays are adopted to form the pulse switching system, normally closed contacts of the relays K1, K3, K5 and K7 are connected to the output end a of the pulse monitoring system, and normally open contacts of the relays are connected to the output end B of the pulse monitoring system; normally closed contacts of relays K2, K4, K6 and K8 are connected to the output end B of the pulse monitoring system, and normally open contacts are connected to the output end A of the pulse monitoring system; the common end of relays K1, K2, K3, K4, K5, K6, K7, K8 is connected to one end of output control relays KO1, KO2, KO3, KO4, KO5, KO6, KO7, KO8, and the other end of output control relays KO1, KO2, KO3, KO4, KO5, KO6, KO7, KO8 is connected to output ports P1, P2, P3, P4, P5, P6, P7, P8. The output port is used for being connected with an electrode in the electrode system and is formed by an aviation plug, a quick-release plug or a common plug and the like. In this connection, when the control coil of the relay is not energized, no pulse is output between the output ports P1, P3, P5, P7 and P2, P4, P6, P8, and the possibility of erroneous operation can be effectively reduced. If the pulse polarity is to be switched, the switching of the pulse polarity can be realized by the control signals corresponding to the control pins L1 and L2 of the corresponding relays.

The electrode system is made up of one or more electrodes. Each electrode is composed of a conductive material with certain strength, a high-voltage lead and a connector, wherein a part of area of the conductive material is covered with an insulating layer. The connector is used for connecting with an output port in the pulse switching system. The electrode is used for distributing positive pulse energy and/or negative pulse energy to biological tissues, and the form of the electrode can be needle type, flat plate type, adsorption type, clamping type, expansion type and the like; the electrodes are connected by a quick connector and a pulse switching system.

The acquisition system mainly comprises electrocardiosignal monitoring equipment, a jitter acquisition module, an optical fiber temperature measurement sensor, an infrared temperature measurement sensor and the like. The electrocardiosignal monitoring equipment is used for monitoring heartbeat signals of a treatment object, and when the control system identifies the refractory period of the heartbeat signals through an artificial intelligence algorithm, the control system outputs control signals to control the pulse generation system to output pulses. The optical fiber temperature measuring sensor is inserted into the biological tissue and is used for monitoring the temperature of the biological tissue in vivo; the infrared temperature measurement sensor monitors the temperature of the body surface biological tissue through an infrared image; the jitter acquisition module is used for monitoring the jitter degree of the biological tissue, and the jitter degree can be calculated by measuring or calculating the average value or the amplitude of the jitter acceleration of the biological tissue when the pulse is output, or by adopting the maximum value or the average value of the displacement of the biological tissue.

The positioning system comprises an image acquisition module, a field depth module, a three-dimensional scanning module, an acceleration module, a speed module, a marker and the like. An alternative method is to place one or more markers on the biological tissue and then to collect the position information of the markers by a positioning system; when no marker exists, the feature on the biological tissue can be identified by an image identification method to be used as a positioning point to acquire the position information of the biological tissue. The velocity module and/or the acceleration module are fixed or placed near the biological tissue treatment site to obtain velocity and/or acceleration information of the biological tissue. The three-dimensional scanning module and/or the depth of field module assist the image acquisition module in acquiring the position information of the biological tissue. The positioning system transmits the acquired information to the control system, calculates and predicts the position and the angle of the biological tissue, and then controls the follow-up system to clamp the electrode system and/or the electrode to move and rotate according to the prediction result.

The isolation system is used for isolating high-voltage and low-voltage control signals and generally comprises an optical coupling chip, a magnetic coupling system, capacitive coupling and electro-optic and photoelectric conversion. The optical coupling chip and/or the electro-optic and photoelectric conversion are/is preferably selected, the optical coupling chip is relatively simple to use, and the withstand voltage value of the optical coupling chip is generally 1500V-5000V; the use of electro-optical and photoelectric conversion for the construction thereof is relatively complicated, but the withstand voltage thereof generally increases as the length of the optical fiber increases. Whether an optical coupler chip or an optical fiber isolation system is selected, the isolation withstand voltage is required to be higher than the maximum pulse voltage of the system, the minimum control pulse width is required to be smaller than the minimum control pulse width of the pulse generation system, and the maximum control frequency is required to be higher than the maximum pulse frequency of the pulse generation system.

The control system generally comprises a main control chip, a random access memory, a read-only memory, a digital-to-analog converter, an analog-to-digital converter, a power management chip, a communication chip and the like. Because the parallel characteristic of the FPGA is very suitable for logic control, a preferred solution is to use the FPGA as a main control chip. The control system is connected with the upper computer system through the communication bus, and after a control command of the upper computer system is obtained, corresponding control signals are generated and sent to each system, so that the control of the self-adaptive follow-up type pulse ablation system is realized. The control system also uploads the acquired data to the upper computer system through the communication bus, and the upper computer system displays the data to an operator. The data collected by the control system include, but are not limited to, treatment progress, amplitude and waveform of the pulse voltage and current, status of various components of the system, and impedance changes of the biological tissue.

The upper computer system can be formed by a computer or an industrial personal computer and is provided with a display, a keyboard, a mouse, a microphone, a loudspeaker, a touch pad, a stylus, fingerprint identification and other equipment. The control software suitable for the self-adaptive follow-up type pulse ablation system runs on a computer, and the flexible control of the self-adaptive follow-up type pulse ablation system can be realized through the software.

The cloud platform can be a self-built cloud platform and can also be a commercial cloud platform, and the core of the cloud platform is an artificial intelligence algorithm running on the cloud platform. In the set of artificial intelligence algorithm, the past treatment object condition, treatment parameters, treatment effect and postoperative feedback are input into the cloud platform, and the artificial intelligence algorithm outputs the optimal parameters or the optimal parameter range suitable for each treatment.

The second embodiment mainly describes the structure of the adaptive follow-up pulse ablation system. The third embodiment of the present invention will be described below for a specific case.

The adaptive follow-up pulse ablation system and method are described below in conjunction with a treatment case.

The liver of an adult male has a tumor of approximately spherical volume, 20mm in diameter. As can be known through an electromagnetic simulation model and an artificial intelligence algorithm running on a cloud platform, for a nearly spherical tumor with the diameter of 20mm, the optimal electrode spacing is 2 electrodes with the diameter of 12mm, the optimal ablation pulse electric field strength for the tumor at the liver part of a male is 3kV/cm, the number of pulse groups is 100, each pulse group comprises 30 positive pulses and 30 negative pulses, the period of each pulse is 3 microseconds, the pulse width of each pulse is 1 microsecond, and the impedance value of the tumor is generally about 100 ohms. The pulse voltage is 1.2cm multiplied by 3kV/cm, namely 3.6kV according to the calculation of the field intensity multiplied by the distance; according to the requirements of the self-adaptive follow-up pulse ablation system, the automatic adjusting range can be set according to a threshold value of +/-20%, and then the pulse voltage value output by the upper computer is 3.6kV +/-20%, the pulse width is 1 microsecond +/-20%, and the period is 3 microseconds +/-20%. After the parameters are set by the upper computer system, the control command is transmitted to the control system through the upper computer system, and then the pulse group can be applied in the refractory period of the electrocardiogram signal under the control of the control system.

After an operator controls a mechanical arm in a follow-up system to insert an electrode according to a designed distance, before therapeutic pulses are output, the pulse generation system is controlled to output pulses with the voltage amplitude of 30V, the pulse width is 100 microseconds, then the magnitude of pulse current is detected, if the pulse current amplitude is larger than 0.6A, the impedance of a tumor part is smaller than 50 ohms and smaller than half of a normal value of 100 ohms, which indicates that the conditions of short circuit, incorrect electrode pin distance setting, incorrect electrode pin conducting area size setting and the like exist; if the amplitude of the pulse current is less than 0.15A, it indicates that the impedance of the tumor site is greater than 200 ohms, and greater than twice the normal value of 100 ohms, it may be that the electrodes are not inserted, the contact is poor, or the insulating layer of the electrodes is not set to a suitable length. When the abnormal condition occurs, the medical staff or the operating staff is reminded to check, and the formal treatment is carried out after the check is qualified.

When a bridge circuit is used as a main circuit of the pulse generating system, under the condition of not considering the voltage drop of the circuit, the amplitude of the output voltage of the direct-current power supply is equal to the amplitude of the output pulse voltage; the amplitude of the output pulse voltage is generally slightly smaller than that of the output voltage of the direct current power supply after the voltage drop of the circuit is considered. The difference is related to circuit parameters, current parameters, etc., and can be generally measured in advance through experiments. The voltage drop measured by experiments in advance is 50V, the output voltage of the direct current power supply can be set to be 3.65kV +/-20% so as to compensate the voltage drop, so that pulse parameters applied to biological tissues are more accurate, and then whether the output pulse voltage of the direct current power supply reaches a specified value or not is detected, or the voltage of the direct current power supply is fed back and adjusted in real time by adopting the measured value of a pulse monitoring system.

The control system firstly disconnects the pulse power supply switch, the pulse discharge switch and the energy storage power supply switch, disconnects the energy storage discharge switch and closes the charging switch in the energy storage system. And then setting the amplitude of the output voltage of the high-voltage power supply to be 3.65kV, measuring the voltage value on the energy storage capacitor through a charging measurement circuit in the energy storage system, and calculating whether the charging speed is normal or not. When the voltage value reaches 3.65kV and the charging speed is normal, an energy storage power supply switch of the energy storage system and a pulse power supply switch in the pulse generation system can be closed, and then control signals are sequentially sent to the switches S1 and S4, the switches S2 and the switches S3 through the control system to generate pulses.

When an emergency occurs, an operator presses an emergency button on the machine, the pulse power supply switch, the energy storage power supply switch and the charging switch in the energy storage system are disconnected, the pulse discharging switch and the energy storage discharging switch are closed, pulses are separated from biological tissues, and meanwhile, energy stored in the pulse generating system and the energy storage system is released through the pulse discharging resistor and the energy storage discharging resistor.

As shown in fig. 6, the process of adaptively adjusting the pulse (burst) parameters according to the present invention is as follows:

s1, start;

s2, outputting a detection pulse (burst);

s3, judging whether the equipment, the electrode, the connection state and the like are normal, if so, executing the next step, and if not, executing the step S10;

s4, outputting a pulse (burst) of the initial setting parameter;

s5, recording the jitter degree of the treatment object and judging whether the jitter degree is in the set range, if yes, executing the next step, and if not, executing the step S11;

s6, recording the temperature and temperature rise of the treatment part and judging whether the temperature and temperature rise are in a set range, if so, executing a step S8, otherwise, executing the next step;

s7, proportionally reducing the energy of the positive pulse (group) and the energy of the negative pulse (group) or reducing the output speed of the pulse (group), and then jumping to execute the step S6;

s8, using the pulse (burst) parameters to continue outputting;

s9, judging whether the set number or the treatment duration or the treatment part parameter reaches the set value, if any one or more are yes, executing the step S21; if not, executing step S5;

s10, reminding medical staff to check and quit pulse (group) output; then, step S21 is executed;

s11, judging whether the adjusting direction is determined, if yes, executing the next step, and if not, executing the step S13;

s12, judging whether the adjusting direction is to increase the energy ratio of the positive pulse (group) to the negative pulse (group), if yes, executing the next step, and if not, executing the step S16;

s13, increasing the ratio of the energy of the positive pulse (group) to the energy of the negative pulse (group) and outputting the pulse (group), and then recording the shaking condition of the treatment object;

s14, judging whether the shaking degree of the treatment object is reduced, if yes, executing the next step, and if not, executing the step S20;

s15, setting the adjusting direction to increase the energy ratio of the positive pulse (group) and the negative pulse (group), and then executing the step S5;

s16, reducing the ratio of the energy of the positive pulse (group) to the energy of the negative pulse (group) and outputting the pulse (group), then recording the shaking condition of the treated object, and then executing the next step;

s17, judging whether the shaking degree of the treatment object is reduced, if yes, executing the next step, and if not, executing the step S19;

s18, setting the adjusting direction to reduce the energy ratio of the positive pulse (group) and the negative pulse (group), and then executing the step S5;

s19, setting the adjusting direction to increase the energy ratio of the positive pulse (group) and the negative pulse (group), and then executing the step S5;

s20, setting the adjusting direction to reduce the energy ratio of the positive pulse (group) and the negative pulse (group), and then executing the step S5;

and S21, ending.

Adjusting the ratio of the energy of the positive pulse (group) to the energy of the negative pulse (group), specifically acquiring jittering acceleration information or jittering displacement information of the biological tissue in the application process of each pulse (group) and/or in a specific time after the application of the pulse (group), and calculating the amplitude and/or average value of the acceleration information and/or the displacement information as an evaluation parameter of the jittering biological tissue; changing the positive pulse energy and/or the negative pulse energy by adjusting one or more parameters of the pulse width, the amplitude, the rising time and the falling time of the pulse; wherein changing the pulse width of a pulse to adjust the ratio of positive and negative pulse energies is shown in fig. 7, changing the amplitude of a pulse to adjust the ratio of positive and negative pulse energies is shown in fig. 8, changing the pulse width and/or amplitude of a pulse to adjust the ratio of positive and negative pulse energies is shown in fig. 9, and changing the rise and/or fall times of a pulse to adjust the ratio of positive and negative pulse energies is shown in fig. 10.

At the initial moment, applying positive pulse (group) and negative pulse (group) with equal energy, recording the jitter degree, if the jitter degree is larger than the set threshold, changing the ratio of the positive pulse energy to the negative pulse energy, judging whether the jitter degree is reduced, if so, indicating that the adjusting direction is correct, and continuing to adjust along the direction until the threshold requirement is met; if the jitter degree is not reduced, the ratio of the positive pulse energy and the negative pulse energy is adjusted according to the reverse direction; the ratio of the positive pulse energy to the negative pulse energy is adjusted in this manner until the degree of jitter is reduced to within the threshold range.

The process of adjusting the degree of shaking of the biological tissue by changing the ratio of the positive pulse energy and the negative pulse energy is described below with reference to fig. 6 and 11. As shown in fig. 11, a first pulse (burst) of equal positive and negative pulse energy is applied and the maximum acceleration of the biological tissue dither is acquired. If the maximum acceleration of the shaking of the biological tissue is 10 meters per second square and the set maximum acceleration threshold is 3 meters per second square, the positive pulse energy and the negative pulse energy need to be adjusted by an adaptive method. There are various ways to adjust the energy of the positive and negative pulses, such as changing the pulse width, changing the pulse amplitude, changing the rise and fall times, and even changing the pulse shape, and this is done by changing the pulse width. Keeping the energy of the negative pulse unchanged, adjusting the energy of the positive pulse to be 110% of the energy of the negative pulse, then applying the pulse to the biological tissue, recording the shaking maximum acceleration of the biological tissue at the moment, and if the shaking maximum acceleration of the biological tissue at the moment is 6 meters per square second, indicating that the direction of pulse regulation is correct. However, the energy ratio of the positive pulse energy and the negative pulse energy, which minimizes the jitter of the biological tissue, may be between 100% and 110%, or may be greater than 110%. The ratio of the positive pulse energy to the negative pulse energy is continuously adjusted to 120%, then the maximum acceleration of the shaking of the biological tissue at the moment is recorded to be 2 meters per second squared, the set threshold value of the shaking degree of the biological tissue is met, and then the pulse can be continuously applied according to the situation. If the maximum acceleration of the shaking of the biological tissue is 8 meters per second squared at a ratio of the applied positive pulse energy and the applied negative pulse energy of 120%, it is stated that the adjustment should be within 100% to 110% of the ratio of the applied positive pulse energy and the applied negative pulse energy. If the pulse is adjusted for multiple times, the output of the pulse is suspended within the set pulse parameter range and information is returned to an upper computer system for prompting, or the intensity of the pulse is reduced within the set allowable range. The ratio of the positive pulse energy to the negative pulse energy is less than 100% and similar to the case where the positive pulse energy is greater than the negative pulse energy, and is not described herein.

With pulse ablation, the treatment time is typically within a few minutes, and the temperature and/or temperature rise of the biological tissue is typically low, but there is still a need to prevent thermal damage. When the temperature and/or the temperature rise of the biological tissue is detected to rise to the threshold value, under the condition of maintaining the proportion of the positive pulse energy and the negative pulse energy unchanged, reducing the energy of the positive pulse and the negative pulse, continuously detecting whether the temperature of the tumor part is reduced, and if the temperature is reduced, continuing to apply the pulse according to the parameter; if the temperature is still increased, the intensity of the pulse is further reduced and/or the speed of pulse application is reduced. An alternative temperature threshold may be set at 45 degrees celsius or a temperature rise threshold of 8 degrees celsius.

With the continuous application of the pulse, the impedance of the biological tissue is changed, and when the monitored impedance of the biological tissue reaches a set threshold value, the output of the pulse can be stopped; or the system can automatically stop the pulse after the set treatment number is reached; or the operator stops outputting the pulse according to actual conditions. After the treatment pulse stops, the energy storage discharge switch in the energy storage system and the pulse discharge switch in the pulse generation system are closed, the residual energy stored in the energy storage system and the pulse generation system is released, then medical staff or operating staff are prompted to remove the electrode, and thus, a treatment process is completed.

It should be understood that the above-described steps are only an implementation part of the present application, but it is apparent to those skilled in the art that several modifications can be made without departing from the principle of the present application, and these modifications should also be construed as the protection scope of the present application.

While embodiments of the invention have been shown and described, it will be understood by those of ordinary skill in the art that: various changes, modifications, substitutions and alterations can be made to the embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the claims and their equivalents.

Claims

1. An adaptive follow-up pulse ablation system, comprising:

the system comprises a power supply system, an isolation transformer, a high-voltage power supply, an energy storage system, a pulse generation system, a pulse monitoring system, a pulse switching system, an electrode system, a control system, an isolation system, an acquisition system, a positioning system, a follow-up system, an upper computer system and a cloud platform;

the power supply system comprises: providing energy to various systems and modules of the adaptive follow-up pulse ablation system;

the isolation transformer: directly and/or indirectly providing energy for the high-voltage power supply and subsequent systems in the self-adaptive follow-up pulse ablation system, and isolating the high-voltage power supply and the subsequent systems from a power grid;

the high-voltage power supply: directly and/or indirectly providing energy for the energy storage system and subsequent systems in the adaptive follow-up pulse ablation system;

the energy storage system comprises: storing energy provided by the high-voltage power supply and directly and/or indirectly providing energy for the pulse generation system and subsequent systems thereof;

the pulse generation system: generating corresponding pulses and/or pulse groups according to the parameters of the pulses and/or pulse groups given by the control system;

the pulse monitoring system: monitoring one or more parameters of waveform, amplitude, phase, pulse width, period, interval and field intensity of one or more of pulse voltage, pulse current, pulse electric field and pulse magnetic field output by the pulse generation system;

the pulse switching system: delivering pulses and/or pulse packets to different electrodes of the electrode system to accommodate biological tissue of different sizes, shapes, locations and properties;

the electrode system is as follows: comprising one or more electrodes for delivering pulses and/or pulse packets to the biological tissue;

the control system is: receiving a control command output by the upper computer system, outputting a corresponding control signal and sending the control signal to each system and module of the self-adaptive follow-up type pulse ablation system, collecting various data of the self-adaptive follow-up type pulse ablation system, and adjusting parameters of pulses and/or pulse groups in real time and in a self-adaptive manner during treatment;

the isolation system: the high-energy part and the low-energy part are isolated, so that the safety of a treatment object, an operator and the self-adaptive follow-up pulse ablation system is ensured;

the acquisition system comprises: collecting state information of the biological tissue, wherein the state information comprises one or more of electrocardiogram signals, jitter information, temperature information and temperature rise information;

the positioning system: collecting the spatial position, the speed and the acceleration information of the biological tissue, transmitting the information to the control system, and predicting by the control system to obtain one or more of displacement information and rotation information of the biological tissue at the next moment;

the follow-up system comprises: controlling the electrode system to move and/or rotate along with the biological tissue, and reducing the relative displacement and relative rotation of the electrode and the biological tissue;

the upper computer system comprises: receiving input information of an operator or generating a corresponding control command according to a calculation result of the cloud platform, sending the control command to the control system, receiving data of the control system for calculation, storage, display and forwarding, and uploading a treatment object condition, a treatment parameter, a treatment effect and postoperative feedback in treatment to the cloud platform;

the cloud platform: the optimal treatment parameter range for the current treatment is calculated according to the past treatment object condition, the treatment parameters, the treatment effect and the postoperative feedback.

2. The adaptive follow-up pulse ablation system according to claim 1, wherein the cloud platform generates the most suitable treatment parameters for each treatment through an artificial intelligence algorithm; after each treatment, the condition of the treated object, the treatment parameters, the treatment effect and the postoperative feedback are input into the system for training, and the parameters of the artificial intelligence algorithm are continuously adjusted, so that the treatment effect of each time is optimal;

and/or the follow-up system comprises: a multi-degree-of-freedom mechanical arm and a clamping device; the clamping device is arranged on the multi-degree-of-freedom mechanical arm and clamps the electrode system; the multi-degree-of-freedom mechanical arm receives a control signal of the control system to move and/or rotate;

and/or the control system applies pulses and/or pulse groups in the refractory period of the electrocardiogram signals of the treatment object according to the pulse and/or pulse group parameter range provided by the cloud platform and/or the operator through the upper computer system; adjusting the ratio of the positive pulse and/or pulse group energy and the negative pulse and/or pulse group energy of the self-adaptive follow-up pulse ablation system in real time according to the jitter degree of the biological tissue measured by the acquisition system so that the jitter degree of the biological tissue is reduced to be within a threshold range or the minimum; adjusting the output speed of the pulse and/or the pulse group in real time and/or proportionally adjusting the energy of the positive pulse and/or the pulse group, the energy of the negative pulse and/or the pulse group and controlling the temperature and/or the temperature rise of the biological tissue to be within a threshold value range; the position and angle information of the biological tissue acquired by the positioning system controls the follow-up system to enable the electrodes in the electrode system to move and/or rotate along with the biological tissue, so that the relative displacement and relative rotation of the electrodes relative to the biological tissue are reduced;

and/or the acquisition system comprises: one or more of an electrocardiogram module, a jitter acquisition module, a temperature acquisition module and a temperature rise acquisition module; the electrocardiogram module acquires electrocardiogram signals of a treated object; the jitter acquisition module acquires jitter information of a treatment object; the temperature acquisition module acquires temperature information of the biological tissue; the temperature rise acquisition module acquires temperature rise information of the biological tissue;

and/or the positioning system comprises: the image acquisition module comprises one or more of a depth of field module, a three-dimensional scanning module, an acceleration module, a speed module and a marker besides the image acquisition module; when the marker exists, the marker is arranged on the biological tissue and used for conveniently acquiring the position information of the biological tissue; the speed module acquires the speed of the biological tissue, and the acceleration module acquires the acceleration of the biological tissue; the depth of field module and the three-dimensional scanning module are used for assisting the image acquisition module to acquire the position information of the biological tissue; the positioning system transmits this information to the control system, which predicts the position and angle of rotation to which the biological tissue will be moved at the next moment.

3. The adaptive follow-up pulse ablation system according to claim 1, wherein the energy storage system comprises: the device comprises a charging resistor, a charging switch, an energy storage element, a charging measurement circuit, an energy storage discharge switch, an energy storage discharge resistor and an energy storage power supply switch; after receiving a starting signal of the control system, closing the charging switch and opening the energy storage discharging switch to charge the energy storage element; when the energy on the energy storage element is detected to reach a preset value, closing the energy storage power supply switch to provide energy for the pulse generation system; when the adaptive follow-up type pulse ablation system needs to be stopped, the energy storage power supply switch and the charging switch are disconnected, the energy storage discharging switch is closed, the energy output is cut off, the energy stored on the energy storage element is released, and the safety of a treatment object, an operator and the adaptive follow-up type pulse ablation system is guaranteed.

4. The adaptive follow-up pulse ablation system of claim 1, wherein the pulse generation system comprises: the pulse generating circuit, the pulse discharging switch, the pulse discharging resistor and the pulse power supply switch; under the control of the control system, controlling the energy in the energy storage element in the energy storage system so as to generate pulses and/or pulse groups with adjustable one or more parameters of pulse width, period, number, interval, positive polarity, negative polarity, rising time and falling time;

and/or the pulse monitoring system is used for monitoring one or more parameter information of waveform, amplitude, phase, pulse width, period, interval and field intensity of one or more of pulse voltage, pulse current, pulse electric field and pulse magnetic field output by the pulse generating system and feeding back the parameter information to the control system, and the pulse and/or pulse group parameters are adjusted in real time after the control system is operated;

and/or the pulse switching system is used for outputting the pulses and/or pulse groups generated by the pulse generating system to one or more electrodes of the electrode system so as to adapt to the biological tissues with different sizes, shapes, positions and properties;

and/or the electrode system comprises one and/or more electrodes for dispensing positive pulses and/or burst energy, negative pulses and/or burst energy to the biological tissue, the electrodes being in the form of one or more of needles, plates, adsorption, clamps, expansion; the electrodes in the electrode system are connected with the pulse switching system by adopting a connector; the electrodes in the electrode system have conductive and insulating regions of a certain length for transmitting pulse energy to the biological tissue; the connector comprises one or more of a quick-release plug, an aviation plug and a common plug.

5. The adaptive follow-up pulse ablation system according to claim 1, wherein the isolation system isolates the high energy portion from the low energy portion by one or more of photoelectric and electro-optical conversion, optical coupling isolation, magnetic coupling isolation, and capacitive coupling isolation to ensure the safety of the subject, the operator, and the adaptive follow-up pulse ablation system.

6. The adaptive follow-up pulse ablation system according to claim 1, wherein the upper computer system sends control commands to the control system through the isolation system by one or more programs, software, in an upper computer running in the upper computer system; receiving data sent by the control system through the isolation system; sending the treatment object condition, treatment parameters, treatment effect and postoperative feedback to the cloud platform; and receiving the treatment parameters and/or the treatment parameter range given by the cloud platform.

7. An adaptive follow-up pulse ablation method, comprising:

adjusting the ratio of the positive pulse and/or pulse group energy to the negative pulse and/or pulse group energy in real time and in a self-adaptive manner in the pulse output process, so that the biological tissue jitter degree is within a threshold value range;

in the pulse output process, proportionally adjusting the energy of positive pulses and/or pulse groups and the energy of negative pulses and/or pulse groups and/or the output speed of the pulses and/or the pulse groups in real time and in a self-adaptive manner, so that the temperature rise of the biological tissue is controlled within a threshold value range;

during treatment, the position and the angle of the electrode are adjusted in real time through the follow-up system, and the relative displacement and the relative rotation of the electrode in the electrode system relative to the biological tissue are reduced to be within a threshold value range;

calculating whether one or more parameters of impedance, capacitive reactance and inductive reactance of the biological tissue meet a treatment ending condition or not by an artificial intelligence algorithm by acquiring one or more parameters of waveform, amplitude, phase, pulse width, period, interval and field intensity of one or more of pulse voltage, pulse current, pulse magnetic field and pulse electric field applied to the biological tissue, and ending the output of pulses and/or pulse groups when the treatment ending condition is met; or the treatment number and the treatment duration reach set values; or at any time the operator decides whether to end the pulse and/or pulse burst output.

8. The adaptively trailing pulse ablation method according to claim 7, wherein the adjusting the ratio of positive pulse and/or burst energy to negative pulse and/or burst energy comprises: acquiring jittering acceleration information or jittering displacement information of the biological tissue in the application process of each pulse and/or pulse group and/or in a specific time after the application of the pulse and/or pulse group, and calculating the amplitude and/or average value of the acceleration information and/or the displacement information as an evaluation parameter of the jittering biological tissue; changing the positive pulse and/or pulse group energy and/or the negative pulse and/or pulse group energy by adjusting one or more parameters of the pulse width, amplitude, rise time, fall time of the pulse and/or pulse group; at the initial moment, applying positive pulses and/or pulse groups and negative pulses and/or pulse groups with equal energy, recording the jitter degree, if the jitter degree is greater than a set threshold value, changing the ratio of the energy of the positive pulses and/or pulse groups to the energy of the negative pulses and/or pulse groups, judging whether the jitter degree is reduced, if so, indicating that the adjustment direction is correct, and continuing to adjust along the direction until the threshold value requirement is met; if the jitter level is not reduced, the ratio of the positive pulse and/or pulse group energy to the negative pulse and/or pulse group energy is adjusted in the reverse direction; the ratio of the positive pulse and/or burst energy to the negative pulse and/or burst energy is adjusted in this manner until the degree of jitter is reduced to within the threshold range.

9. The adaptive follow-up pulse ablation method of claim 7, wherein the proportionally adjusting the output speed of positive pulses and/or pulse burst energies and negative pulses and/or pulse burst energies and/or pulses and/or pulse bursts comprises: acquiring whether the temperature and/or the temperature rise of the biological tissue in the pulse and/or pulse group application process is within a set threshold range, and if so, maintaining the current positive pulse and/or pulse group energy and negative pulse and/or pulse group energy and/or output speed thereof; and if the temperature and/or the temperature rise exceed the set threshold value, proportionally reducing the energy of the positive pulse and/or the pulse group and the energy of the negative pulse and/or the pulse group and/or reducing the output speed of the positive pulse and/or the pulse group and the negative pulse and/or the pulse group, and controlling the temperature and/or the temperature rise of the biological tissue to be within the threshold value range.

10. The method of adaptive follow-up pulse ablation according to claim 7, wherein the method of adjusting the position and angle of the electrodes comprises: acquiring current position and/or angle information of the biological tissue through one or more devices and/or methods in an image acquisition module, a speed module, an acceleration module and three-dimensional scanning to calculate and/or predict displacement information and/or rotation information of the biological tissue; then driving the follow-up system to control the electrode system to move and/or rotate according to the predicted position; correcting a prediction algorithm and parameters thereof according to the difference between the prediction result and the actual movement and/or rotation result of the biological tissue, so that the prediction result is optimal;

predicting t_nAt the moment the position P to which the biological tissue is to be moved_nThe coordinates of (c) are calculated using the following formula:

wherein P is_n-1、P_n-2、P_n-3Are each t_n-1、t_n-2、t_n-3Coordinates of a position of the biological tissue at the time;

v is the velocity measured by the velocity module,

a is the acceleration measured by the acceleration module,

Δ t is the time interval of two sampling instants.