CN114271931B - Pulse ablation system - Google Patents
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- CN114271931B CN114271931B CN202111607247.6A CN202111607247A CN114271931B CN 114271931 B CN114271931 B CN 114271931B CN 202111607247 A CN202111607247 A CN 202111607247A CN 114271931 B CN114271931 B CN 114271931B
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Abstract
The invention discloses a pulse ablation system, comprising: an ablation device provided with at least one electrode for releasing a pulsed electric field and/or collecting an electrical signal; a pulsed electric field generator for generating a pulsed sequence for transmission to the electrodes to generate a pulsed electric field at the electrodes; a processor module for controlling the pulsed electric field generator to generate a pulse sequence and controlling a pulsed electric field profile across the ablation device. The pulse ablation system can control the waveform form of the pulse sequence by controlling the pulse electric field generator to generate the pulse sequence through the processor module, can control the distribution of the pulse electric field on an ablation device, and can accurately deliver pulse energy to tissues to be ablated.
Description
Technical Field
The invention relates to the technical field of ablation, in particular to a pulse ablation system.
Background
Atrial fibrillation is the most common arrhythmia, with a morbidity of about 1% and increasing with age, with a morbidity of up to 10% in people over 80 years of age. Studies have shown that catheter ablation is an effective means of restoring and maintaining heart rhythm in atrial fibrillation patients. The ablation energy commonly used at present is mainly radio frequency energy, and the freezing energy is auxiliary, and the two ablation modes have advantages, and have corresponding limitations, such as lack of selectivity of the ablation energy (cold or hot) to damage tissues in an ablation area, dependence on the leaning force of a catheter, and possibility of damaging adjacent esophagus, coronary artery or phrenic nerve and the like, thereby affecting the treatment effect. Pulse ablation is a novel ablation mode taking a high-voltage electric field as energy, is a non-thermal ablation technology, has tissue selectivity, and can effectively induce myocardial cells to generate irreversible electroporation by adopting a plurality of short-time release high-voltage pulses to ablate energy through designing a proper pulse electric field, so that the myocardial cells are disintegrated and dead, and the aim of treatment is fulfilled. The ablation system is generally used in combination with a three-dimensional electrophysiology mapping system or a multi-channel electrophysiology recorder, and the combined medical equipment processes the collected intracavitary electrocardiogram signals and then provides the intracavitary electrocardiogram signals for a doctor to diagnose. However, the input voltage of these devices is typically in mV level, and if the connection between the two devices is not controlled during the process of ablation by the pulsed electric field, the high voltage of the ablation tends to damage the expensive three-dimensional electrophysiology mapping system or the multi-channel electrophysiology recorder. There is therefore a great need for a pulsed ablation system that achieves accurate delivery of a pulsed electric field to tissue to be ablated for treatment without damaging the medical device used therewith.
Disclosure of Invention
According to one aspect of the present invention, there is provided a pulsed ablation system comprising:
an ablation device provided with at least one electrode for releasing a pulsed electric field and/or collecting an electrical signal;
a pulsed electric field generator for generating a pulsed sequence for transmission to the electrodes to generate a pulsed electric field at the electrodes;
a processor module for controlling the pulsed electric field generator to generate a pulse sequence and controlling a pulsed electric field profile across the ablation device.
The pulse ablation system can control the waveform form of the pulse sequence by controlling the pulse electric field generator to generate the pulse sequence through the processor module, can control the distribution of the pulse electric field on an ablation device, and can accurately deliver pulse energy to tissues to be ablated.
In some embodiments, the system further comprises a signal acquisition control module, wherein the signal acquisition control module is connected with the processor module and the ablation device, and the signal acquisition control module can control an electrode on the ablation device to acquire an electric signal and transmit the electric signal to the processor module.
Therefore, the electric signals of tissues can be collected through the electrodes of the ablation device, and the functions of releasing a pulse electric field and collecting the electric signals are realized in the same system.
In some embodiments, the processor module calculates parameters of the pulse sequence from the received electrical signals and transmits to the pulsed electric field generator to generate a corresponding pulse sequence from the parameters.
Therefore, the processor module can calculate parameters of the pulse sequence according to the collected electrical signals (current values) of the tissue, generate the pulse sequence which is suitable for the tissue at the site and is optimal to deliver to the tissue according to the parameters, and can enable the generation of the personalized and customized pulse sequence, and the generated pulse electric field is more suitable for the requirement of the tissue to be ablated.
In some embodiments, the pulse electric field generator presets parameters of a plurality of pulse sequences, and the pulse electric field generator is capable of receiving a control signal of the processor module to generate a corresponding pulse sequence according to the preset parameters.
Therefore, different pulse sequence parameters can be selected from a plurality of preset pulse sequence parameters to generate a plurality of different pulse sequences so as to adapt to ablation requirements of tissues at different positions or different conditions.
In some embodiments, the system further comprises a user control module, the user control module is in bidirectional communication connection with the processor module, the user control module can acquire user instructions and transmit the user instructions to the processor module, and the processor module analyzes the received user instructions to obtain control instructions and then controls the digestion device and/or the pulse electric field generator based on the control instructions.
Therefore, the user can accurately control the generation and the delivery of the pulse, and ablation is better realized.
In some embodiments, the user control module has a user interface through which information from the processor module can be graphically displayed.
Thus, the user can control the running condition of the system in real time through the user interface.
In some embodiments, the ablation device further comprises a pulse output switch and a pulse output control module, wherein the pulse output switch is connected with the ablation device, the pulse electric field generator and the pulse output control module, the pulse output control module is connected with the processor module, receives a control instruction of the processor module and controls the pulse output switch to transmit a pulse sequence to the ablation device according to the control instruction.
Thus, the delivery of pulse energy can be accurately controlled.
In some embodiments, the pulse output control module is capable of controlling the switching speed and/or switching position of the pulse output switch to control the pulse delivery of electrodes on the ablation device.
Therefore, the pulse electric field energy applied between different electrodes on the ablation device can be accurately controlled.
In some embodiments, the pulse output switch is connected to a signal acquisition control module that is capable of controlling the switching speed and/or switching position of the pulse output switch to control the acquisition of electrical signals from electrodes on the ablation device.
Thus, the pulse output switch can be switched to connect the electrode with the measuring channel, so that the electrode can collect the electric signal.
In some embodiments, the parameters of the pulse train include pulse number, pulse amplitude, pulse width, and interval time;
the pulse sequence is a monophasic pulse sequence, a biphasic pulse sequence, a bipolar pulse sequence or an asymmetric bipolar pulse sequence.
In some embodiments, the asymmetric bipolar pulse sequence comprises a plurality of positive pulses and a negative pulse sequentially emitted in chronological order within a period;
the pulse amplitude values Vp of the plurality of forward pulses are the same;
the pulse amplitude value Vn of the negative pulse is smaller than the pulse amplitude value Vp of the positive pulse;
the pulse width value NPD of the negative pulse is larger than the pulse width value PPD of the positive pulse.
Therefore, the asymmetric bipolar pulse sequence provides asymmetric bidirectional pulses, so that the comfort of a patient can be improved, and the ablation effect is better. The pulse amplitude value Vn of the negative pulse is smaller than the pulse amplitude value Vp of the positive pulse and the pulse width value NPD is larger than the pulse width value PPD of the positive pulse, i.e. compared with the positive pulse, the negative pulse has smaller voltage and longer duration, and can reduce the direct current component in the pulse period to the greatest extent.
In some embodiments, the parameters of the asymmetric bipolar pulse sequence are functionally related as follows:
NPD×Vn＝PPD×np×Vp；
where NPD is the pulse width value of the negative going pulse, vn is the pulse amplitude value of the negative going pulse, PPD is the pulse width value of the positive going pulse, np is the number of positive going pulses, and Vp is the pulse amplitude value of the positive going pulse.
In some embodiments, the interval time between the positive going pulse and the negative going pulse of the asymmetric bipolar pulse train is a polarity inversion time PIP, the polarity inversion time PIP ranging from 10ns to 10000ns.
In some embodiments, the forward pulse interval time tinterval between the plurality of forward pulses within one period of the asymmetric bipolar pulse train is in the range of 10ns to 5000ns.
In some embodiments, the asymmetric bipolar pulse has one period t=np×ppd+ (np-1) ×tinterval+pip+npd;
where np is the number of positive pulses, PPD is the pulse width value of the positive pulses, tinterval is the positive pulse interval time between the positive pulses, PIP is the polarity inversion time, and NPD is the pulse width value of the negative pulses.
Drawings
Fig. 1 is a block diagram of a pulse ablation system according to a first embodiment of the present invention;
FIG. 2 is a waveform diagram of a monophasic pulse sequence of a pulse ablation system according to some embodiments of the present invention;
FIG. 3 is a waveform diagram of a biphasic pulse train of a pulse ablation system according to some embodiments of the invention;
FIG. 4 is a waveform diagram of a bipolar pulse train of a pulse ablation system according to some embodiments of the invention;
FIG. 5 is a waveform diagram of an asymmetric bipolar pulse train of a pulse ablation system according to some embodiments of the present invention;
fig. 6 is a block diagram of a pulse ablation system according to a second embodiment of the present invention.
Detailed Description
The invention is described in further detail below with reference to the accompanying drawings.
Example 1
Fig. 1 schematically illustrates a pulse ablation system according to one embodiment of the invention. As shown, the pulse ablation system includes: ablation device 100, pulsed electric field generator 200, processor module 300, user control module 400, pulsed output switch 500, and pulsed output control module 600.
An ablation device 100 provided with a set of electrodes for releasing a pulsed electric field and/or collecting electrical signals; the ablation device 100 is connected to a pulsed electric field generator 200, and pulses generated by the pulsed electric field generator 200 are delivered to electrodes, through which a pulsed electric field is formed to ablate tissue. The ablation device 100 and the pulsed electric field generator 200 are connected through a pulse output switch 500, i.e., the pulse output switch 500 controls connection or disconnection between the output channel of the pulsed electric field generator 200 and the electrode. Every adjacent two of the group of electrodes can be configured as a negative electrode, a positive electrode and a positive electrode at the same time. The ablation device 100 may be a wire-shaped ablation catheter, a basket-shaped ablation catheter, or a matrix-shaped ablation catheter.
A pulse electric field generator 200 for generating a pulse train to be transmitted to the electrodes to generate a pulse electric field at the electrodes; the pulse electric field generator 200 is connected to the pulse output switch 500, and the on-off of the output channel between the pulse electric field generator 200 and the electrode of the ablation device 100 is controlled by the pulse output switch 500.
The pulse electric field generator 200 may include a main control module, a high voltage unit, an energy storage unit, a pulse amplitude control unit and a pulse width control unit, where the high voltage unit is connected with the energy storage unit and is used to generate a high voltage potential to charge the energy storage unit; the pulse amplitude control unit is used for controlling the pulse amplitude of the pulse output by the energy storage unit; the pulse width control unit is used for controlling the pulse width of the pulse output by the energy storage unit. Specifically, the high voltage unit may be a double half-bridge circuit for generating a high voltage potential and transmitting the high voltage potential to the energy storage unit; the energy storage unit can be a capacitor or a capacitor bank formed by a plurality of capacitors, and the pulse amplitude control unit can be a chopper circuit, and the pulse amplitude of the pulse output by the energy storage unit can be adjusted through the chopper circuit; the pulse width control unit can be an electronic switch group, and can form the pulse with adjustable pulse amplitude and adjustable positive and negative polarities through the on and off time of the electronic switch group.
The pulsed electric field generator 200 further comprises a dual foot switch for triggering a signal controlling the release of the pulse train generated by the pulsed electric field generator 200. Wherein the left pedal is ARM, and the other right pedal is PULSE. PULSE release can be completed only by stepping on ARM and then stepping on PULSE in sequence, so that user error discharge is avoided, and a release mechanism is safer.
The pulse sequence generated by the pulsed electric field generator 200 is determined by parameters such as the number of pulses, pulse amplitude, pulse width, and interval time. Wherein, the number of the pulses can be 1-120; the pulse amplitude may be 100-800 volts; the pulse width may be 20-200 microseconds; the time interval may be 40-400 microseconds.
The parameters of the pulse electric field generator 200 for generating the pulse sequence may be preset in advance in the system, and the pulse electric field generator 200 may be capable of receiving the control signal of the processor module 300 to select the corresponding preset parameters and generating the corresponding pulse sequence output according to the preset parameters.
The pulse train may be monophasic, biphasic, bipolar, and asymmetric bipolar.
As shown in fig. 2, in some embodiments, the pulse train is defined as monophasic pulses, which may be either positive or negative voltages, the number of individual monophasic pulses in the pulse train may be 1-120, the pulse amplitude Um1 may be 100-800 volts, the pulse width tw1 may be 40-400 microseconds, and the interval CP1 may be 40-400 microseconds.
As shown in fig. 3, in some embodiments, the pulse train is defined as a biphasic pulse comprising a positive voltage and a negative voltage, the number of individual biphasic pulses in the pulse train may be 1-60, the pulse amplitude Um2 may be 100-800 volts, the pulse width tw2 may be 40-400 microseconds, and the interval CP2 may be 40-400 microseconds.
As shown in fig. 4, in some embodiments, the pulse train is defined as bipolar pulses, which include positive and negative voltages, the number of individual bipolar pulses in the pulse train may be 1-60, the pulse amplitude Um3 may be 100-800 volts, the pulse width tw3 may be 40-400 microseconds, the interval CP3 may be 40-400 microseconds, and the polarity inversion time PIP may be 10-10000 nanoseconds.
The novel energy for ablating the pathological tissues of the human body during the pulsed electric field ablation has the advantages of non-thermal effect, selectivity, short time and the like, and can be applied to the ablation in the tumor field and the ablation in the arrhythmia field. Common modes of pulse delivery are predominantly unipolar pulses and bipolar pulses. The pulse width of these pulses is typically several hundred nanoseconds to several hundred microseconds, and by loading tissue cells with pulses of a certain pulse width, the transmembrane potential Δvm can be induced, the transmembrane potential that causes irreversible electroporation of the cells being denoted Δvire, which is typically 200mv-1000mv due to the different morphology, size and lipid bilayer results of the cells of different tissues. Irreversible electroporation can be caused within 10 μs after the cell reaches the threshold.
One limiting factor of current pulsed electric field ablation is skeletal muscle contraction, which is caused by the fact that unipolar pulses generate a large direct current component, which stimulates nerves to cause muscle contraction, pain and poor patient comfort, so that the patient needs to be fully anesthetized during surgery, and muscle relaxants are used. While bipolar pulse mode can reduce the DC component due to the balance of positive and negative directions, the depth of electroporation damage is limited.
As shown in fig. 5, in some embodiments, a novel pulse sequence for ablating diseased tissue of a human body is provided, the pulse sequence being defined as an asymmetric bipolar pulse sequence comprising a plurality of positive pulses and a negative pulse sequentially issued in time sequence over a period;
the pulse amplitude values Vp of the plurality of forward pulses are the same;
the pulse amplitude value Vn of the negative pulse is smaller than the pulse amplitude value Vp of the positive pulse;
the pulse width value NPD of the negative going pulse is greater than the pulse width value PPD of the positive going pulse.
Therefore, the asymmetric bipolar pulse sequence provides asymmetric bidirectional pulses, so that the comfort of a patient can be improved, and the ablation effect is better. The positive pulse has the function of inducing DeltaVire, the pulse amplitude value Vn of the negative pulse is smaller than the pulse amplitude value Vp of the positive pulse, and the pulse width value NPD of the negative pulse is larger than the pulse width value PPD of the positive pulse, namely the negative pulse is smaller in voltage and longer in duration compared with the positive pulse, and the direct current component in the pulse period can be reduced to the greatest extent.
The integral absolute value of the pulse amplitude Vp of the positive going pulse over time is generally equal to the absolute value of the pulse amplitude Vn of the negative going pulse integral over time or only slightly different. The pulse width value NPD (duration) of a negative going pulse when the pulse is an ideal square wave is a function of the number np of positive going pulses and the pulse width value PPD:
NPD×Vn＝PPD×np×Vp；
where NPD is the pulse width value of the negative going pulse, vn is the pulse amplitude value of the negative going pulse, PPD is the pulse width value of the positive going pulse, np is the number of positive going pulses, and Vp is the pulse amplitude value of the positive going pulse.
The interval time between positive and negative going pulses of the asymmetric bipolar pulse train is a polarity inversion time PIP, which ranges from 10ns to 10000ns.
The forward pulse interval time tinterval between the plurality of forward pulses within one period of the asymmetric bipolar pulse train is in the range of 10ns to 5000ns.
Asymmetric bipolar pulse one pulse period t=np×ppd+ (np-1) ×tinterval+pip+npd.
Preferably, 3 pulse waveforms are usually used as a pulse period, namely, two positive pulses and one negative pulse are sequentially issued according to time sequence, the two positive pulses have the same pulse amplitude value Vp, the pulse amplitude value Vn of one negative pulse is smaller than the pulse amplitude value Vp of the positive pulse, the two positive pulses have the same current, the current of one negative pulse is smaller than the current of the positive pulse on the premise that the load impedance is not changed, the interval tinterval of the two positive pulses is 10-5000ns, and the polarity inversion time PIP of the bipolar pulse is 10ns-10000ns. The pulse width value PPD (duration) of the forward pulse is in the range of optionally nanoseconds or microseconds, 100-1000ns for nanoseconds and 1-50 mus for microseconds.
The functional relationship between the pulse width value NPD of the negative pulse and the number np and the pulse width value PPD of the positive pulse is:
NPD×Vn＝2×PPD×Vp；
one pulse period: t=2×ppd+tinterval+pip+npd;
the pulse period time interval CP4 can be arbitrarily adjusted, typically in the range of 1-400 mus.
An asymmetric bipolar pulse sequence is compared to conventional 1:1 can reduce direct current component to the maximum extent, improve patient's comfort level to can guarantee the damage degree of depth under the circumstances that reduces direct current component, the ablation effect is guaranteed.
A processor module 300 for controlling the pulsed electric field generator 200 to generate a pulse sequence and controlling the pulsed electric field profile across the ablation device 100. The processor module 300 is in two-way communication connection with the user control module 400, the user control module 400 can receive user instructions of a user and transmit the user instructions to the processor module 300, and the processor module 300 analyzes the received user instructions to obtain control instructions so as to control other modules to operate. The processor module 300 is further connected to the pulse electric field generator 200, specifically, a user may select a preset pulse sequence through the user control module 400, and the processor controls the pulse electric field generator 200 to generate a corresponding pulse sequence output according to the selected pulse sequence parameter according to a user instruction. The pulse ablation system of the embodiment controls the pulse electric field generator 200 to generate a pulse sequence through the processor module 300 so as to control the waveform form of the pulse sequence, and switches the parameters of different preset pulse sequences at any time according to the user instruction, so that the pulse electric field generator 200 generates the pulse sequence with the required waveform form, and the pulse ablation system is suitable for the requirements of various situations in operation.
The system may further comprise a memory unit which may store some data to enable failure detection mechanisms of the system, generation and transmission of pulse sequences, configuration of the state of the electrode output channels, selection of discharge/measurement modes, delivery times of pulse energy, etc. For example, the memory unit may configure the normal initial parameters of the various modules, optimized treatment parameters, algorithms defining pulse sequences from intra-luminal electrocardiogram signals, clinical data of the distribution of the electric field across the ablation device 100, etc. The storage unit may be integrated in the processor module 300 or may be provided separately from the processor module 300, so long as the storage unit is configured to be capable of bi-directional communication with the processor module 300, so as to enable access to data.
The processor module 300 is further connected to a pulse output control module 600, the pulse output control module 600 is connected to the pulse output switch 500, receives control instructions of the processor module 300 and controls the pulse output switch 500 to transmit a pulse sequence to the ablation device 100 according to the control instructions.
The pulse output switch 500 may include a set of electronic switches, each of which individually controls the on-off of one output channel and an electrode, each of which is controlled by the pulse output control module 600, the pulse output control module 600 being capable of controlling the switching speed and/or switching position of the pulse output switch 500 to control the pulse delivery of the electrode on the ablation device 100. The pulse output control module 600 controls the switching speed and/or switching position of a set of electronic switches based on control instructions from the processor module 300 to control the delivery of pulses to the various electrodes on the ablation device 100, thereby controlling the distribution of the pulsed electric field across the ablation device 100. The state of each electronic switch in a group of electronic switches can be controlled individually or simultaneously. Specifically, a set of electronic switches may include Insulated Gate Bipolar Transistors (IGBTs), metal Oxide Semiconductor Field Effect Transistors (MOSFETs), power transistors (GTRs), gate turn-off thyristors (GTOs).
The user control module 400 comprises a graphical user interface through which a user may input and transmit parameters to the processor module 300 for parameter control, and the state of system operation or parameters may be transmitted to the user interface of the user control module 400 via the processor module 300 for graphical display. The user control module 400 may be a touch screen, which may be a resistive screen or a capacitive screen. In some other embodiments, the user control module 400 is integrated with the processor module 300, such as a PC, and the user interface is an interface for a user to communicate with the system, through which an operator can input parameters to the processor module 300, and through which some data can be graphically presented.
The user interface is provided with battery icons representing the states of the energy storage units (capacitor banks), when the capacitor banks are not charged, the battery icons are yellow, battery blocks representing electric quantity are zero, ARM icons are gray and can not be clicked, PULSE icons are gray and can not be clicked, and ARM icons and PULSE icons in the user interface correspond to functions of foot ARM and foot PULSE one by one; switching from the uncharged state of the capacitor bank to the charged state, and pressing an ARM pedal in the pedal or clicking a battery icon in a user interface; when the capacitor bank starts to charge and is not fully charged, the battery icon is yellow, the battery block representing the electric quantity gradually rises along with the electric quantity of the capacitor bank, the ARM icon is gray and can not be clicked, and the PULSE icon is gray and can not be clicked; when the capacitor bank is fully charged, the battery icon turns green, the battery block is also fully charged with the battery icon, the ARM icon turns blue, the ARM icon can be clicked, the PULSE icon is gray, and the ARM icon cannot be clicked; when the capacitor bank is in a full-power state, pressing the ARM pedal in the pedal or clicking the ARM icon in the user interface will enter a 10-second countdown state of PULSE energy emission, at which time the buzzer will sound a prompt sound of 'ticker' every 1 second from entering the state, the ARM icon becomes gray and is not optional, and the PULSE icon becomes blue and is optional, in which state, pressing the PULSE pedal in the pedal or clicking the PULSE icon in the user interface within 10 seconds, the PULSE energy will be emitted or directly emitted within the absolute refractory period of the ventricle; if the "PULSE" pedal in the pedal is not pressed or the "PULSE" icon in the user interface is clicked within 10 seconds, the user interface will not release PULSE energy and will switch directly to the interface state where the capacitor bank is fully charged. After the transmission of the pulse energy is completed once, the capacitor bank is automatically charged, and the interface state of the capacitor bank in the charging is switched. If the capacitor bank is in a fully charged state, no pulse energy is released within 5 minutes, the capacitor bank energy will automatically bleed through the safety loop, and the user interface switches from the capacitor bank fully charged state to the capacitor bank uncharged state.
The PULSE release mechanism of the system can release PULSE energy only by triggering two signals through the ARM icon and the PULSE icon or by foot, avoids the possibility of false touch, and is provided with an automatic release function, so that the system is safer in the use process.
The pulse ablation system of the present embodiment controls the pulse electric field generator 200 to generate a pulse sequence through the processor module 300, can control the waveform form of the pulse sequence, can control the distribution of the pulse electric field on the ablation device 100, can accurately deliver pulse energy to the tissue to be ablated, and the asymmetric bipolar pulse sequence generated by the pulse electric field generator 200 can provide patient comfort and achieve a higher lesion depth.
Example two
As a description of the second embodiment provided by the present invention, only the differences from the first embodiment described above will be described below. As shown in fig. 6, the system of the present embodiment further includes a signal acquisition control module 700, where the signal acquisition control module 700 is capable of controlling the electrodes on the ablation device 100 to acquire electrical signals and transmit the electrical signals to the processor module 300. The function of pulsed electric field release and electrical signal acquisition can be achieved within the same system by collecting electrical signals of tissue through the electrodes of ablation device 100.
Specifically, the system further includes a set of measurement channels, each measurement channel is connected to one electrode in the set of electrodes, the measurement channels are connected to the pulse output switch 500, the pulse output switch 500 is further used for switching between the measurement channels and the output channels, that is, the electrodes can be controlled to be connected to the output channels or to be connected to the measurement channels through the pulse output switch 500, the signal acquisition control module 700 is connected to the pulse output switch 500, and the signal acquisition control module 700 can control the switching speed and/or the switching position of the pulse output switch 500 so as to safely control the electric signal acquisition of the electrodes on the ablation device 100.
The signal acquisition control module 700 is in two-way communication with the processor module 300, and is capable of receiving a control instruction of the processor module 300 to control the ablation device 100 to perform an electric signal acquisition function, and transmitting an acquired electric signal (intra-cavity electrocardiogram signal) to the processor module 300 for analysis.
It is believed in the industry that the magnitude of the intra-luminal electrocardiogram amplitude has a correspondence with scarring of the tissue, and that myocardial tissue in this region is already necrotized when the voltage of the bipolar intra-luminal electrocardiogram signal is < 0.1 mv.
The algorithm model is pre-stored in the system, and the processor module 300 can invoke the algorithm model to calculate parameters of the pulse sequence from the received electrical signal, and transmit the calculated parameters of the pulse sequence to the pulse electric field generator 200 to generate a corresponding pulse sequence according to the parameters. The processor module 300 calculates parameters of the pulse sequence from the intra-cavity electrocardiogram signal received by the measurement channel and transmits the parameters to the pulse electric field generator 200 to generate the pulse sequence optimal for the tissue at the site according to the parameters.
In some embodiments, the electrical signal acquisition process may be that the pulsed electric field generator 200 may output an excitation voltage of low amplitude and specific frequency, which is transmitted to the local tissue through the ablation device, and the measurement channel may acquire the current value. The processor module 200 can infer the composition of the tissue from the current values fed back.
After the electric signal is collected, the system can be switched back to an ablation mode of releasing the pulse, before pulse energy is output, the processor module 300 informs the pulse output switch 500 to disconnect the electrode 120 from the measurement channel through the signal collection control module 700, controls the pulse output switch 500 to control the electrode to be connected with the output channel, and delivers a pulse sequence generated according to the calculation parameters of the collected electric signal to the electrode at the corresponding position to ablate the tissue. After the pulse is released, the connection between the electrode 120 and the output channel is disconnected, and the connection is switched to the measurement channel for the next intra-cavity electrocardiogram signal acquisition.
The switching between pulse output and signal acquisition is realized through the process, and medical equipment which is matched with the medical equipment for recording the intracardiac electric signals is not damaged.
The setting mode can recalculate parameters of the pulse sequence according to the collected electric signals of the tissues, generate the pulse sequence according to the parameters and deliver the pulse sequence to the tissues, so that the generated pulse sequence has the characteristic of personalized ablation, and the generated pulse electric field is more attached to the requirements of the tissues to be ablated.
In the description of the present invention, relational terms such as first and second, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Moreover, the terms "comprises," comprising, "or" includes not only those elements but also other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising … …" does not exclude the presence of other like elements in a process, method, article, or apparatus that comprises an element. The terms "connected," "secured," and the like are to be construed broadly, and may be, for example, fixedly connected, detachably connected, integrally connected, or electrically connected; can be directly connected or indirectly connected through an intermediate medium. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances.
Finally, it should be noted that: the above embodiments are only for illustrating the technical solution of the present invention, and not for limiting the same; although the invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical scheme described in the foregoing embodiments can be modified or some or all of the technical features thereof can be replaced by equivalents; such modifications and substitutions do not depart from the spirit of the invention.
Claims (13)
1. A pulse ablation system, comprising:
an ablation device provided with at least one electrode for releasing a pulsed electric field and/or collecting an electrical signal;
a pulsed electric field generator for generating a pulsed sequence for transmission to the electrodes to generate a pulsed electric field at the electrodes; the pulse sequence is an asymmetric bipolar pulse, and the asymmetric bipolar pulse sequence comprises a plurality of positive pulses and a negative pulse which are sequentially distributed in a period according to time sequence;
a processor module for controlling the pulsed electric field generator to generate a pulse sequence and controlling a pulsed electric field distribution on the ablation device;
the pulse output switch is connected with the ablation device, the pulse electric field generator and the pulse output control module, and the pulse output control module is connected with the processor module, receives a control instruction of the processor module and controls the pulse output switch to transmit a pulse sequence to the ablation device according to the control instruction;
the pulse output switch comprises a group of electronic switches, each electronic switch independently controls the on-off state between one output channel and the electrode, each electronic switch is controlled by a pulse output control module, and the pulse output control module can control the switching speed and/or the switching position of the pulse output switch so as to control the pulse transmission of each electrode on the ablation device, thereby controlling the distribution form of the pulse electric field on the ablation device.
2. The pulsed ablation system of claim 1, further comprising a signal acquisition control module coupled to the processor module and the ablation device, the signal acquisition control module capable of controlling electrodes on the ablation device to acquire electrical signals and transmitting the electrical signals to the processor module.
3. The pulse ablation system of claim 2, wherein the processor module calculates parameters of the pulse train from the received electrical signals and transmits to the pulsed electric field generator to generate a corresponding pulse train from the parameters.
4. The pulse ablation system of claim 1, wherein the pulse electric field generator presets parameters of a plurality of pulse sequences, the pulse electric field generator capable of receiving control signals from the processor module to generate corresponding pulse sequences according to the preset parameters.
5. The pulse ablation system of claim 4, further comprising a user control module in bi-directional communication with the processor module, wherein the user control module is capable of obtaining user instructions and transmitting the user instructions to the processor module, and wherein the processor module is configured to control the ablation device and/or the pulse electric field generator based on the control instructions after analyzing the received user instructions to obtain the control instructions.
6. The pulsed ablation system of claim 5, wherein the user control module has a user interface through which information from the processor module can be graphically displayed.
7. The pulsed ablation system of claim 1, wherein the pulsed output switch is coupled to a signal acquisition control module that is capable of controlling a switching speed and/or a switching position of the pulsed output switch to control electrical signal acquisition of electrodes on the ablation device.
8. The pulse ablation system of any of claims 1-5, wherein the parameters of the pulse train include a number of pulses, a pulse amplitude, a pulse width, and a time interval.
9. The pulse ablation system of claim 1, wherein the pulse amplitude values Vp of the plurality of forward pulses are the same;
the pulse amplitude value Vn of the negative pulse is smaller than the pulse amplitude value Vp of the positive pulse;
the pulse width value NPD of the negative pulse is larger than the pulse width value PPD of the positive pulse.
10. The pulse ablation system of claim 9, wherein parameters of the asymmetric bipolar pulse train are functionally related as follows:
NPD×Vn＝PPD×np×Vp；
where NPD is the pulse width value of the negative going pulse, vn is the pulse amplitude value of the negative going pulse, PPD is the pulse width value of the positive going pulse, np is the number of positive going pulses, and Vp is the pulse amplitude value of the positive going pulse.
11. The pulse ablation system of claim 10, wherein the interval time between the positive going pulse and the negative going pulse of the asymmetric bipolar pulse train is a polarity reversal time PIP, the polarity reversal time PIP ranging from 10ns to 10000ns.
12. The pulse ablation system of claim 11, wherein a forward pulse interval time tinterval between the plurality of forward pulses within one period of the asymmetric bipolar pulse train is in a range of 10ns to 5000ns.
13. The pulse ablation system of claim 12, wherein the asymmetric bipolar pulse has a period T = np x ppd+ (np-1) x tinterval+pip+npd;
where np is the number of positive pulses, PPD is the pulse width value of the positive pulses, tinterval is the positive pulse interval time between the positive pulses, PIP is the polarity inversion time, and NPD is the pulse width value of the negative pulses.
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| CN115005961B (en) * | 2022-07-07 | 2023-05-12 | 上海普实医疗器械股份有限公司 | Cardiac pulse electric field ablation system |
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