CN114652426A

CN114652426A - Impulse ablation apparatus, system, control method and readable storage medium

Info

Publication number: CN114652426A
Application number: CN202011595846.6A
Authority: CN
Inventors: 王彦磊; 孙毅勇; 沈刘娉
Original assignee: Shanghai Microport EP MedTech Co Ltd
Current assignee: Shanghai Microport EP MedTech Co Ltd
Priority date: 2020-12-23
Filing date: 2020-12-23
Publication date: 2022-06-24
Also published as: WO2022134713A1

Abstract

The invention provides a pulse ablation device which is used for carrying out pulse ablation on a part to be ablated of a patient. The pulse ablation device comprises a processor module and a control module, wherein the processor module is used for outputting a control signal according to the type of the heart rhythm of the patient; the pulse electric field generating module is used for outputting a pulse signal according to the control signal, the pulse electric field generating module is used for being connected with an intervention device, an electrode is configured on the intervention device, and the pulse signal acts on a part to be ablated through the electrode to implement pulse ablation. The invention provides a pulse ablation system, which further comprises an interventional device, wherein an electrode is arranged at the far end of the interventional device, and the electrode applies a pulse electric field to a part to be ablated by using the pulse signal. In the pulse ablation system, the processor module can determine the time for applying the pulse electric field according to the heart rhythm types of different patients, so that the influence of the pulse electric field on the normal heart rhythm of the patients can be reduced as much as possible, and the safety of the operation is improved.

Description

Impulse ablation apparatus, system, control method and readable storage medium

Technical Field

The invention relates to the technical field of medical instruments, in particular to a pulse ablation device, a pulse ablation system, a pulse ablation control method and a readable storage medium.

Background

Renal artery sympathetic nerve ablation is an important research direction for the treatment of refractory hypertension. Currently, the renal artery sympathetic nerve is usually ablated by using a radio frequency ablation or cryoablation mode, and both ablation modes are based on a thermal effect, indiscriminate damage can be caused to an ablated target point and healthy tissues around the target point, such as blood vessels, fat and the like, so that once the ablation energy is controlled poorly, various complications, such as renal artery perforation, renal artery stenosis or occlusion, renal artery interlayer and the like, are caused easily. In addition, renal artery sympathetic nerves are distributed around the renal artery, and the renal artery has more branches, and because of the volume limitation of a catheter (such as a balloon catheter), the current ablation treatment for the renal artery branch nerves is not deep enough.

The manner of pulse ablation may also be used to ablate renal artery sympathetic nerves. When the ablation therapy is carried out by adopting a pulse ablation mode, the pulse ablation system applies an intermittent high-intensity narrow-pulse electric field to the tissue to be ablated, so that the cell membrane of the tissue cell generates micropores, and the permeability of the cell membrane is increased. When the strength of the pulsed electric field reaches a certain level, irreparable large perforations appear in the cell membrane, a process known as irreversible electroporation, leading to apoptosis. Due to the fact that different types of tissue cells have different tolerance to the pulsed electric field, when the pulsed electric field is applied to ablation treatment, the effect of destroying specific cells and tissues to be ablated can be achieved by selecting specific parameters of the pulsed electric field. In addition, the short duration of the pulse ablation procedure, not based on thermal effects, can further mitigate damage to surrounding healthy tissue. Therefore, pulse ablation has also been widely used in ablation treatment of organs such as the heart and various tumors.

Although pulse ablation has the advantages, the pulse electric field during pulse ablation easily causes the electrical activity of the heart of a patient to be abnormal, and myocardial tremor and abnormal heart rate are easily caused. Particularly, for intractable hypertension patients, different levels and different types of arrhythmia are mostly accompanied according to clinical statistics, and for such patients, the function of the myocardial cells at the origin of arrhythmia is more easily interfered by external stimulation, so that more disordered electrical activity may be caused, and the safety of the pulse ablation operation is greatly influenced.

Disclosure of Invention

The invention aims to provide a pulse ablation device, a pulse ablation system, a pulse ablation control method and a readable storage medium, which can determine the time for applying a pulse electric field according to the heart rhythm types of different patients, reduce the influence of pulse ablation on the normal heart rhythm of the patients and improve the safety of the operation.

In order to achieve the above object, the present invention provides a pulse ablation apparatus comprising:

the processor module is used for outputting a control signal according to the heart rhythm type; and

the pulse electric field generating module is used for outputting a pulse signal according to the control signal, the pulse electric field generating module is used for being connected with an intervention device, an electrode is configured on the intervention device, and the pulse signal passes through the electrode to act on a part to be ablated so as to implement pulse ablation.

Optionally, the control signal includes a pulse signal issuing timing, where different types of the cardiac rhythms correspond to different pulse signal issuing timings, and the pulse signal issuing timing is set to be within a specific time period of each cardiac cycle of the electrocardiograph signal.

Optionally, the pulse ablation apparatus further includes an electrocardiographic signal acquisition module, configured to acquire electrocardiographic signals, and the processor module receives the electrocardiographic signals, obtains the heart rhythm type according to characteristic parameters of the electrocardiographic signals, and determines the pulse signal issuing time according to the heart rhythm type.

Optionally, the processor module is configured to continuously update the control signal according to the continuously received electrocardiographic signal and output the updated control signal to the pulsed electric field generation module.

Optionally, the pulse ablation device further includes an input module, configured to input the rhythm type, and the processor module determines the pulse signal issuing timing according to the rhythm type.

Optionally, the control signal includes a pulse signal parameter; after the processor module sets the pulse signal issuing opportunity and the pulse signal parameters, the processor module issues the control signal to the pulse electric field generation module, and the control signal controls the pulse electric field generation module to continuously generate pulse signals with preset parameters in a specific time period of each cardiac cycle.

Optionally, the electrocardiographic signal includes a P wave, a QRS complex, and a T wave; the characteristic parameters of the electrocardiosignal comprise the starting time, the peak time and/or the ending time of a P wave, an R wave and a T wave, wherein the R wave is a wave in a QRS complex, the time period from the end point of the P wave to the start point of the QRS complex is the PQ segment of the cardiac cycle, the time period from the end point of the QRS complex to the start point of the T wave is the ST segment of the cardiac cycle, and the specific time period comprises the PQ segment and the ST segment.

Optionally, the heart rhythm types include abnormal heart rhythms and normal heart rhythms, and the abnormal heart rhythms include supraventricular arrhythmias and ventricular arrhythmias;

when the type of rhythm is supraventricular arrhythmia, the pulse signal delivery timing is set to be within the PQ segment of each of the cardiac cycles; and/or

When the rhythm types are ventricular arrhythmia and normal rhythm, the pulse signal delivery timing is set to be located in the ST segment of each cardiac cycle.

Optionally, the pulse signal issuing timing includes a time and a duration of applying the pulse signal; the time of applying the pulse signal is controlled by an initial delay time length, the initial delay time length refers to the time of delaying the pulse signal after the characteristic parameter occurs, and the time of applying the pulse signal is after the initial delay time length; the duration refers to the duration of the pulse signal in each of the cardiac cycles.

Optionally, the processor module determines an average value of the initial delay duration and the duration according to the cardiac electrical signals in a plurality of cardiac cycles before the pulse signal is applied to the to-be-ablated part, so as to uniformly set the time of applying the pulse signal and the duration.

Optionally, the processor module determines the initial delay duration and the duration in each cardiac cycle according to a characteristic parameter of the electrocardiographic signal in each cardiac cycle, so as to set the time of applying the pulse signal and the duration respectively.

Optionally, in the PQ segment of each cardiac cycle, the time when the pulse signal is applied is within 30ms to 55ms after the P-wave peak value, and the duration is 50ms to 75 ms; and/or the presence of a gas in the gas,

and in the ST segment of each cardiac cycle, the moment of applying the pulse signal is within 50 ms-75 ms after the peak value of the R wave, and the duration is 80 ms-150 ms.

Optionally, the pulse ablation apparatus further comprises a stimulation module for generating a stimulation signal, and the stimulation signal is applied to a target object through the intervention device so as to determine the to-be-ablated part.

Optionally, the processor module further includes a display for displaying an operation interface and an analysis result of the central processing unit; the pulse signal generation module also comprises a control panel, and the pulse signal parameters can be remotely controlled through the control interface and/or controlled through the control panel.

In addition, the present invention also provides a pulse ablation system comprising:

the pulse ablation device;

the interventional device is used for being connected with the pulse ablation equipment, an electrode is arranged at the far end of the interventional device, and the pulse signal acts on the part to be ablated through the electrode so as to implement pulse ablation.

In addition, the invention also provides a control pulse ablation method, which comprises the following steps: and generating a control signal according to the rhythm type, wherein the control signal comprises the sending time of the pulse signal, and different rhythm types correspond to different sending time of the pulse signal. Optionally, the pulse signal delivery timing is set to be within a specific time period of each cardiac cycle of the cardiac signal.

Optionally, according to the electrocardiographic signals in a plurality of cardiac cycles, determining an average value of the initial delay duration and the duration to uniformly set the time of applying the pulse signal to the to-be-ablated region and the duration; or the like, or, alternatively,

and determining the initial delay time and the duration time in each cardiac cycle according to the characteristic parameters of the electrocardiosignals in each cardiac cycle so as to respectively set the pulse signal applying time and the duration time of the part to be ablated.

Optionally, the control signal includes pulse signal parameters, and the electrocardiographic signal includes a P wave, a QRS complex, and a T wave; the characteristic parameters of the electrocardiosignal comprise the starting time, the peak time and/or the ending time of a P wave, an R wave and a T wave, wherein the R wave is a wave in a QRS complex, the time period from the end point of the P wave to the start point of the QRS complex is the PQ segment of the cardiac cycle, the time period from the end point of the QRS complex to the start point of the T wave is the ST segment of the cardiac cycle, and the specific time period comprises the PQ segment and the ST segment.

Optionally, the heart rhythm types comprise abnormal heart rhythms and normal heart rhythms, and the abnormal heart rhythms comprise supraventricular arrhythmia and ventricular arrhythmia;

when the type of the rhythm is supraventricular arrhythmia, the pulse signal sending time is positioned in a PQ section of each cardiac cycle;

when the rhythm types are ventricular arrhythmia and normal rhythm, the pulse signal delivery timing is located in the ST segment of each cardiac cycle.

Furthermore, the invention also provides a computer-readable storage medium, on which a computer program is stored which, when being executed by a processor, carries out the method of controlling impulse ablation.

The invention provides a pulse ablation device, which is used for carrying out pulse ablation on a part to be ablated of a patient. The processor module is used for outputting a control signal according to the heart rhythm type of a patient, the pulse electric field generation module is used for outputting a pulse signal according to the control signal, the pulse electric field generation module is used for being connected with an intervention device, an electrode is configured on the intervention device, and the pulse signal acts on a part to be ablated through the electrode to implement pulse ablation. The pulse ablation equipment can determine the time for applying the pulse electric field according to the heart rhythm types of different patients so as to reduce the influence on the normal heart rhythm of the patients and improve the safety of the operation

The pulse ablation equipment further comprises an electrocardiosignal acquisition module used for acquiring electrocardiosignals of a patient, the processor module receives the electrocardiosignals, obtains the heart rhythm type of the patient according to the characteristic parameters of the electrocardiosignals, and outputs control signals according to the heart rhythm type.

Correspondingly, the invention provides a pulse ablation system, which adopts the pulse ablation equipment and further comprises an intervention device, wherein the near end of the intervention device is connected with the pulse ablation equipment, the far end of the intervention device is provided with an electrode, and the electrode applies a pulse electric field to the part to be ablated according to the pulse signal. The pulse signal applies a pulse electric field to the part to be ablated of the patient through the electrode, so that an irreversible electroporation effect is generated on the part to be ablated of the patient. Because the processor module can determine the time for applying the pulse electric field according to the heart rhythm types of different patients, the influence of the pulse electric field on the normal heart rhythm of the patients can be reduced as much as possible.

Drawings

FIG. 1 is a block diagram of a pulse ablation system for renal artery therapy according to an embodiment of the present invention;

FIG. 2 is a schematic illustration of a renal structure and a position of an interventional device in a renal artery in accordance with an embodiment of the present invention;

FIG. 3 is a waveform diagram of a monophasic pulse signal in an embodiment of the present invention;

FIG. 4 is a waveform diagram of a biphasic pulse signal according to an embodiment of the present invention;

FIG. 5 is a schematic diagram of a typical waveform of a body surface electrocardiosignal in one cardiac cycle in an embodiment of the present invention;

FIG. 6 is a flow chart of the operation of a processor module in an embodiment of the invention;

FIG. 7 is a schematic diagram of the application of a pulsed electric field during the ST segment in an embodiment of the present invention;

FIG. 8 is a graphical user interface in an embodiment of the invention;

FIG. 9 is a flow chart of the use of the pulse ablation system in an embodiment of the present invention;

wherein the reference numbers are as follows:

100-a pulse ablation device; 110-an interventional device; 111-electrodes; 120-pulsed electric field generation module; 130-a processor module; 131-a memory; 132-a central processing unit; 133-a display; 134-a control circuit; 140-an electrocardiosignal acquisition module;

200-cardiac cycle; 200 a-a first cardiac cycle; 200 b-second cardiac cycle; segment 201-PQ; 202-ST segment; 202 a-first ST segment; 202 b-second ST segment;

300-a surgical subject; 310-renal artery; 320-abdominal aorta; 330-kidney;

a1 — first information stream; a2 — second information stream; a 3-third information stream; a 4-fourth information stream; a 5-fifth information stream.

Detailed Description

The following describes in more detail embodiments of the present invention with reference to the schematic drawings. The advantages and features of the present invention will become more apparent from the following description. It is to be noted that the drawings are in a very simplified form and are not to precise scale, which is merely for the purpose of facilitating and distinctly claiming the embodiments of the present invention.

As used herein, the terms "proximal" and "distal" refer to the relative orientation, relative position, and orientation of elements or actions with respect to one another from the perspective of a clinician using the medical device, and although "proximal" and "distal" are not intended to be limiting, the term "proximal" generally refers to the end of the medical device that is closer to the clinician during normal operation while the term "distal" generally refers to the end that is first introduced into a patient.

In the process of pulse ablation operation, a high-intensity (high-voltage) pulse electric field can change the cell membrane potential after acting on cells of a tissue to be ablated, so that cell membranes are in a polarization state, and after the polarization trend is rapidly conducted to the heart along adjacent cells, the depolarization and repolarization of cardiac muscle cells can be greatly interfered, and the electrical activity of the heart is abnormal.

Electrical cardiac activity refers to the phenomenon in which cardiomyocytes generate and conduct action potentials, during which the cardiomyocytes along the direction of propagation of the excitation undergo two processes, namely depolarization and repolarization, in sequence. When depolarization and repolarization functions of myocardial cells at certain parts are abnormal, and normal cardiac electrical activity is disturbed, the patient is considered to have arrhythmia. In addition, in the action potential time course of the myocardial cell, the action potential cannot be generated even by applying a strong stimulus in a period from the start of zero-phase depolarization to the time of membrane potential repolarization to a certain extent, and this period is called the effective refractory period of the myocardial cell. It is currently the clinical choice to apply a pulsed electric field during the effective refractory period of the ventricular muscle.

However, according to clinical statistics, the incidence of arrhythmia in hypertensive patients is significantly increased. Patients with refractory hypertension are mostly accompanied by different degrees and different types of arrhythmia. Therefore, myocardial tremor and abnormal heart rate are more likely to be induced during the pulse ablation procedure in hypertensive patients.

Based on this, the present embodiment provides a pulse ablation apparatus and a pulse ablation system, which are used for performing pulse ablation on a to-be-ablated region of a patient, and determining a timing for applying a pulsed electric field according to a heart rhythm type of the patient, so as to minimize an influence of the pulsed electric field on the heart rhythm of the patient and improve the safety of the operation.

The present invention is described by taking renal artery sympathetic nerve impulse ablation as an example, but the impulse ablation apparatus and system of the present invention are not limited to ablation of renal artery sympathetic nerves, and may also be used in ablation operations of other sites or other medical fields, such as pulmonary vein ablation, etc., and the present invention is not limited thereto.

Referring to fig. 1 and fig. 2, fig. 1 is a structural block diagram of a pulse ablation system in this embodiment applied to renal artery treatment, and fig. 2 is a schematic diagram of a renal structure and a position of an intervention device 110 in a renal artery in this embodiment. As shown in fig. 1, the pulse ablation system includes: an interventional device 110 and a pulse ablation apparatus 100, the interventional device 110 may comprise one or more catheters, the distal end of the interventional device 110 is provided with an electrode 111, and the proximal end of the interventional device 110 is connected to the pulse ablation apparatus 100. The electrodes 111 are used to apply a pulsed electric field to the site to be ablated. As shown in fig. 2, the subject 300 is a renal structure, and the left and right renal arteries 310 are a pair of branches of the abdominal aorta 320 and enter the left and right kidneys 330 through the hilum. The renal artery sympathetic nerves are distributed around the renal artery 310, which plays an important role in the regulation of blood pressure. In the renal artery sympathetic nerve impulse ablation process, the interventional device 110 is punctured into the body through a femoral artery or a radial (brachial) artery (not shown), and then reaches the renal artery 310 through a blood vessel passage, and the impulse signal generated by the impulse ablation device 100 acts on the renal artery 310 through the electrode 111 on the interventional device 110, so that the sympathetic nerve around the renal artery 310 undergoes apoptosis, thereby blocking the sympathetic nerve of the renal artery 310 and further achieving the purpose of treating hypertension.

In this embodiment, the interventional device 110 is provided with at least one pair of electrodes 111 for applying energy to tissue and measuring electrophysiological signals, and the electrodes 111 are in the form of a collar-shaped electrode. The electrodes 111 are typically made of a biocompatible metal, such as platinum-iridium alloy or gold. Preferably, the diameter of the electrode 111 is 3F to 7F, and the length of the electrode 111 is 1.5mm to 5 mm. Of course, the number, specific shape, material, diameter and length of the electrodes 111 are not limited in this application, as long as the effect of releasing the pulse ablation energy in this application is satisfied.

Optionally, the electrode 111 is further provided with a perfusion hole, a perfusion cavity communicated with the perfusion hole is arranged in the interventional device 110, and a system user can perfuse the to-be-ablated part with physiological saline through the perfusion cavity and the perfusion hole in the ablation process. The electrodes 111, in addition to being used to apply a pulsed electric field, may also be used to apply electrical stimulation to the renal artery 310 and to measure electrical signals within the renal artery 310.

The distal end of the interventional device 110 may also be provided with a number of sensors, which may be one or more of temperature sensors, pressure sensors, magnetic field sensors, and the like. The data measured by these sensors is typically transmitted to the pulse ablation apparatus 100 via a wire inside the interventional device 110 for assisting in the performance of the ablation procedure. In one embodiment, the sensor comprises a temperature sensor which can be used for monitoring temperature change in the ablation process and avoiding blood vessel damage or blood clot coagulation caused by overhigh temperature due to the application of a pulse electric field for too long time; in another embodiment, the sensor comprises a pressure sensor operable to detect the degree of contact of the interventional device 110 with the vessel wall of the renal artery 310; in yet another embodiment, the sensors include magnetic field sensors that can be used to determine the three-dimensional spatial position and orientation of the interventional device 110 within the patient.

The proximal end of the interventional device 110 is also provided with an operating handle (not shown), and the position and configuration of the distal end of the interventional device 110 within the renal artery 310 can be adjusted by the system user by adjusting the operating handle. In terms of morphology, the interventional device 110 may be linear, spiral, or circular within the renal artery 310, or may have other shapes (e.g., balloon-like, basket-like, etc.) that facilitate ablation.

In one embodiment, the pulse ablation apparatus 100 further comprises a stimulation module (not shown in the figures) for generating a stimulation signal, which is applied to a potential ablation site in a patient through the electrode on the interventional device for the purpose of identifying the ablation site of the patient. Taking the renal artery sympathetic nerve impulse ablation system shown in fig. 1 as an example, if the portion to be ablated needs to be ablated, parameters such as blood pressure and heart rate tend to increase with time when the electrode 111 transmits the stimulation signal; if the part to be ablated does not need to be ablated, parameters such as blood pressure, heart rate and the like do not obviously change along with time when the electrode transmits a stimulation signal.

With continued reference to fig. 1, the pulse ablation device 100 includes: a processor module 130 and a pulsed electric field generation module 120, wherein the processor module 130 is used for outputting a control signal according to the type of the heart rhythm of the patient, and the pulsed electric field generation module 120 outputs a corresponding pulse signal according to the control signal. The pulse electric field generation module is connected with an interventional device 110, and the pulse signal acts on the part to be ablated through an electrode 111 on the interventional device 110 so as to realize pulse ablation. The control signal comprises pulse signal sending timing and pulse signal parameters, wherein different rhythm types correspond to different pulse signal sending timings, and the pulse signal sending timing is set to be positioned in a specific time period of each cardiac cycle of the electrocardiosignal. The pulse signal parameters include electrode 111 number, pulse polarity, pulse voltage, pulse width, pulse duty cycle, and pulse duration. It should be understood that the use of the electrode 111 for ablating the site to be ablated to achieve pulsed ablation is based on a pulsed electric field into which the electrode 111 converts the pulsed signal. Pulse ablation is the application of a high intensity pulsed electric field to the tissue to be ablated, causing irreversible electroporation of the tissue to be ablated to achieve a destructive effect. Different types of tissue cells have different tolerance to the pulsed electric field, and pulse signals with specific parameters are selected to implement pulse ablation, so that the effect of destroying specific tissues to be ablated can be achieved. It should be noted that in this embodiment, the site to be ablated is sympathetic nerves distributed around the renal artery 310.

The various modules of the pulse ablation device 100 are described in detail below.

The pulse ablation device 100 may also be provided with an electrocardiographic signal acquisition module 140 for acquiring electrocardiographic signals of the patient. The processor module 130 is electrically connected with the electrocardiosignal acquisition module 140, the processor module 130 receives and processes the electrocardiosignals, the processor module 130 obtains the rhythm type of the patient according to the characteristic parameters of the electrocardiosignals, and the pulse signal sending time is determined according to the rhythm type.

Preferably, the processor module 130 continuously receives the ecg signal, continuously updates the control signal, and outputs the updated control signal to the pulsed electric field generating module 120.

As an optional implementation manner, the electrocardiographic signal acquisition module 140 is not electrically connected to the processor module 130, the electrocardiographic signal acquisition module 140 acquires an electrocardiographic signal of a patient and then presents the electrocardiographic signal to a system user in the form of an electrocardiogram, and the system user determines the heart rhythm type of the patient according to the characteristic parameters of the electrocardiographic signal. The pulse ablation device 100 further includes an input module (not shown) for inputting the type of heart rhythm of the patient by a system user, and the processor module 130 determines the pulse signal delivery timing according to the type of heart rhythm.

In the pulse ablation apparatus 100 of the present invention, the processor module 130 will process the electrocardiographic signal and then send out a control signal to control the timing of the pulse electric field generation module 120 to generate the pulse signal, and the pulse electric field generation module 120 applies a pulse electric field to the renal artery 310 through the electrode 111 on the interventional device 110, so as to cause the irreversible electroporation effect to occur to the sympathetic nerve surrounding the renal artery 310. Because the processor module 130 can determine the time for applying the pulse electric field according to the heart rhythm types of different patients, the influence of the pulse electric field on the normal heart rhythm of the patients can be reduced as much as possible, so as to improve the safety of the operation.

With continued reference to FIG. 1, the processor module 130 includes a memory 131, a central processor 132, and a control circuit 134. The memory 131 is used to store various data required or generated during operation of the pulse ablation device 100. The central processor 132 is used to analyze and process the data of the pulse ablation device 100. The control circuit 134 performs data interaction with the electrocardiograph signal acquisition module 140 and the pulsed electric field generation module 120. The information flow of the data interaction between the processor module 130 and the electrocardiosignal acquisition module 140 and the pulsed electric field generation module 120 will be described in detail later.

The processor module 130 is typically a computer system, and the processor module 130 further includes a display 133, wherein the display 133 is used for displaying an operation interface and an analysis result of the central processor 132. The processor module 130 typically also includes peripherals, such as a keyboard, a mouse, or a touch screen, for operating the processor module 130.

With continued reference to fig. 1, the pulsed electric field generation module 120 is configured to generate a pulsed signal with adjustable parameters. The pulse signal generated by the pulsed electric field generation module 120 is applied to the renal artery 310 via the electrodes 111 mounted on the interventional device 110 to perform pulse ablation. The pulse signal generated by the pulse electric field generation module 120 releases pulse ablation energy through the electrode 111 on the interventional device 110 to destroy the sympathetic nerves around the renal artery 310, thereby achieving the purpose of blocking the sympathetic nerves of the renal artery 310.

The pulse signal parameters include electrode 111 number, pulse polarity, pulse voltage, pulse width, pulse duty cycle, and pulse duration. Pulse ablation is the application of a high intensity pulsed electric field to the tissue to be ablated, causing irreversible electroporation of the tissue to be ablated to achieve a destructive effect. Different types of tissue cells have different tolerance to the pulsed electric field, and pulse signals with specific parameters are selected to implement pulse ablation, so that the effect of destroying specific tissues to be ablated can be achieved.

It should be appreciated that the pulse signal parameters may be preset in the processor module 130, and the pulsed electric field generation module 120 may continuously generate the pulse signal with the preset parameters in a specific time period of each cardiac cycle according to the control signal. It should be appreciated that the pulse signal parameters may also be manually adjusted by the system user based on experience. In another implementation manner of this embodiment, the pulsed electric field generating module 120 further includes a control panel, and the parameters of the pulse signal are controlled by the control panel. In another implementation of this embodiment, the pulse signal parameters are remotely controlled through a control interface of the processor module 130.

Further, the pulse polarity is in a monophasic pulse mode or a biphasic pulse mode. The following further describes the pulse signals with different pulse polarities with reference to the drawings.

Fig. 3 is a schematic waveform diagram of the monophasic pulse signal in this embodiment. As shown in FIG. 3, U represents the magnitude of the pulse voltage, t_sRepresenting the total duration of the applied pulsed electric field (i.e. the pulse duration), t_cRepresenting the total duration (i.e. pulse width), t, of one complete pulse period₁Representing the power-on time in a pulse period, the pulse duty ratio at this time being t₁/t_c。

Fig. 4 is a waveform diagram of the biphasic pulse signal in the present embodiment. As shown in FIG. 4, U represents the magnitude of the pulse voltage, t_sRepresenting the total duration of the applied pulsed electric field (i.e. the pulse duration), t_cRepresenting the total duration (i.e. pulse width), t, of one complete pulse period₁Is the pulse width of the positive phase, t₂The pulse width of the negative phase is the duty ratio at this time (t)₁+t₂)/t_cIn general, t₁Is equal to t₂。

Further, the pulse polarity is preferably a biphasic pulse, the pulse voltage is preferably adjusted within a range of 0.4kV to 15kV, and the pulse width is preferably adjusted within a range of 0.1us to 100 us. I.e. t₁Or t₂The width adjustment range of (A) is 0.1 us-100 us.

Further, the preferable adjusting range of the pulse duty ratio is 1% -99%.

With continued reference to fig. 1, the ecg signal acquisition module 140 is configured to acquire a patient ecg signal. In a preferred embodiment, the cardiac signal acquisition module 140 is configured to acquire cardiac signals from a body surface of a patient. At this time, the electrode patch with good conductivity is attached to a specific part of the body surface of the patient for collection and recording. In a conventional body surface electrocardiographic examination, one limb lead electrode is usually placed on each limb, and 6 chest lead electrodes are placed in front of the chest.

In another alternative embodiment, the electrical cardiac signal acquisition module 140 is configured to acquire electrical signals from an interior surface of a heart of a patient. The interventional device 110 with the sensing electrode is typically used to access the interior of the heart chamber through a vascular access for acquisition and recording. The interventional device 110 herein serves primarily as a mapping procedure, which is readily understood by those of ordinary skill in the art and will not be redundantly described here. In addition, the ecg signal acquiring module 140 performs various preprocessing operations on the acquired ecg signal, such as notch, filtering, and analog-to-digital conversion. This step is readily understood by those of ordinary skill in the art and will not be described in any greater detail herein.

The electrocardiosignal acquisition module 140 can record the process of electrocardiosignal transmission in the heart, so that the processor module 130 can distinguish the respective time of depolarization and repolarization of the myocardial cells at different positions.

Fig. 5 is a typical waveform diagram of the body surface electrocardiosignal in one cardiac cycle in the embodiment. As shown in fig. 5, the ecg signal includes a P wave reflecting the depolarization process of the atria, a QRS complex reflecting the depolarization process of the ventricles, and a T wave reflecting the repolarization process of the ventricles, which is generally masked by the QRS complex. In one cardiac cycle 200, the PQ segment 201 represents the time from the termination of the P wave to the start of the QRS complex; the ST segment 202 represents the time from the termination of the QRS complex to the start of the T wave. As can be seen from the foregoing, the pulse signal delivery timing is set to be within a specific time period of each cardiac cycle of the cardiac electrical signal, the specific time period including the PQ segment and the ST segment.

With continued reference to fig. 1, the processor module 130 is the core of the control and data processing of the pulse ablation device 100, and next, the information flow of data interaction between the processor module 130 and the ecg signal acquisition module 140 and the pulsed electric field generation module 120 will be described, and the arrows of each information flow represent the direction of data transmission.

With continued reference to FIG. 1, a first stream a1 represents the cardiac signal collected from the patient's body surface and is fed to the cardiac signal collection module 140. A second information stream a2 represents the ecg signal after being pre-processed (e.g., by notching, filtering, and analog-to-digital converting) by the ecg signal acquisition module 140, and enters the processor module 130 via the control circuit 134. The third information stream a3 represents the pulsed signal generated by the pulsed electric field generating module 120 that will be applied to the sympathetic nerves distributed around the renal artery 310 via the electrodes 111 on the interventional device 110. The fourth stream a4 represents the control signals issued by the processor module 130 to the pulsed electric field generation module 120. The control signals include two types: one refers to the timing of the delivery of the pulse signal, and is understood to be the point in time at which the delivery of the pulse signal should be started or stopped within the cardiac cycle 200. The other is applied pulse signal parameters including electrode 111 number for applying a pulse electric field, pulse polarity, pulse voltage, pulse width, pulse duty ratio, pulse duration, and the like. The fifth information stream a5 represents signals collected by the electrodes 111 or sensors on the interventional device 110, such as voltage signals, temperature signals or pressure signals, which are transmitted to the processor module 130 via the control circuitry 134 for subsequent analysis.

The workflow of the processor module 130 is described in detail below.

Fig. 6 is a flowchart of the operation of the processor module 130 in the present embodiment. As shown in FIG. 6, the flow of processor module 130 operation includes the following steps:

step S01: the processor module 130 receives the cardiac electrical signals of the patient collected by the cardiac electrical signal collection module 140.

Step S02: the processor module 130 detects the acquired electrocardiosignals and analyzes the characteristic parameters of the acquired electrocardiosignals in real time.

The characteristic parameters of the electrocardiosignals comprise the starting time, the peak time and/or the ending time of the P wave, the R wave and the T wave. There are a variety of ways in which processor module 130 may perform analysis of characteristic parameters of the cardiac electrical signals, and in one embodiment, analysis is performed using cardiac electrical signals of the I-leads of the body surface standard. In another embodiment, analysis is performed using cardiac electrical signals from the body surface canonical II leads. In other embodiments, the electrocardiosignal characteristic parameters are detected using a dynamic differential thresholding method or are detected using a wavelet transform-based method.

Step S03: the processor module 130 obtains the heart rhythm type of the patient according to the analysis result of the characteristic parameters of the electrocardiosignals.

The heart rhythm types include: abnormal heart rhythms including supraventricular arrhythmias and ventricular arrhythmias, and normal heart rhythms. The processor module 130 can obtain the type of the patient's heart rhythm according to the analysis result of the characteristic parameters of the electrocardiosignals. In one embodiment of this example, the processor module 130 uses a machine learning method to derive the patient's heart rhythm type by analyzing the characteristic parameters of the cardiac electrical signal. Alternatively, in other embodiments, the system user may manually set the patient's arrhythmia type on the steering interface through his or her own experience. Optionally, the processor module 130 is used to obtain the heart rhythm type of the patient, because the processor module 130 can display the heart rhythm type of the patient in real time, so as to prompt the system user of the heart rhythm type of the patient, and avoid the situation that the change of the heart rhythm type of the patient during the operation is overlooked, which causes the operation safety hazard.

Step S04: depending on the patient's rhythm type, the processor module 130 may present a recommended pulse signal delivery timing including the time and duration of application of the pulse signal. The processor module 130 can determine the pulse signal sending time by itself, and the system user can set the pulse signal sending time according to experience.

As described above, the applicant has found that the function of the cardiomyocytes at the origin of arrhythmia is more easily disturbed by external stimuli, which may result in more chaotic electrical activity. Therefore, the method selects to apply the pulse signal in the effective refractory period of the origin part of the arrhythmia so as to reduce the influence of the pulse signal on the existing heart rhythm of the patient as much as possible and improve the safety of the pulse ablation operation. As shown in fig. 5, in a cardiac cycle 200, the PQ segment 201 represents the time from the termination of the P wave to the start of the QRS complex, and the ST segment 202 represents the time from the termination of the QRS complex to the start of the T wave. The P wave reflects the depolarization process of the atria, which is generally buried in the QRS complex, and the PQ segment 201 is considered to approximately reflect the effective refractory period time of the atrial muscle (tissue preceding the ventricles). The QRS complex reflects the depolarization process of the ventricles, the T wave reflects the repolarization process of the ventricles, and the ST segment 202 can be considered to approximately reflect the effective refractory period time of the ventricular muscles. Thus, for a hypertensive patient suffering from supraventricular arrhythmia, the processor module 130 may set the PQ segment 201 of each cardiac cycle 200 to the pulse signaling timing. For hypertensive patients with ventricular arrhythmias and hypertensive patients with normal rhythms, the processor module 130 may set the ST segment 202 of each cardiac cycle 200 to the pulse signal delivery timing.

Optionally, for a patient suffering from supraventricular arrhythmia, the pulse signal delivery timing is set to be located in the PQ segment of each cardiac cycle 200, and when a pulse signal is applied to the to-be-ablated part in the PQ segment of each cardiac cycle 200, the pulse signal is applied within 30ms to 55ms after the P-wave peak value and has a duration of 50ms to 75 ms.

Optionally, for a patient suffering from ventricular arrhythmia or normal cardiac rhythm, the pulse signal sending timing is set to be located in the ST segment of each cardiac cycle 200, and when the pulse signal is applied to the to-be-ablated part in the ST segment of each cardiac cycle 200, the pulse signal is applied within 50ms to 75ms after the peak value of the R wave and has the duration of 80ms to 150 ms.

Of course, in other embodiments, the timing and duration of the initiation of application of the pulse signal within each cardiac cycle 200 may be manually set by the system user on a control panel or control interface depending on the type of heart rhythm of the patient.

Step S05: the pulse signal parameters are set based on the conditions within the renal artery 310 vessel.

The condition in the renal artery 310 blood vessel includes the tolerance of sympathetic nerves distributed around the renal artery 310 to a pulse electric field, the thickness of the blood vessel wall of the renal artery 310, the distance between two electrodes 111 applying the pulse electric field and other information, and the pulse signal related parameters include the electrode 111 number for applying the pulse electric field, the pulse polarity, the pulse voltage, the pulse width, the pulse duty ratio, the pulse duration and the like. The use of pulsed signals of set parameters allows irreversible electroporation of selected sympathetic nerves between the two electrodes 111 while minimizing damage to surrounding healthy tissue, such as the wall of the renal artery 310. The pulse signal parameters may be pre-set in the processor module 130 or may be manually adjusted by the system user based on experience. The method for setting the parameters of the pulse signal is patented and is not described herein.

Step S06: after the pulse signal sending time and the pulse signal parameters are determined, the processor module 130 continuously sends the control signals to the pulse electric field generation module 120 while detecting the electrocardiosignal, and controls the pulse electric field generation module 120 to continuously generate the pulse signals with preset parameters in a specific time period of each cardiac cycle 200.

To further illustrate the timing of the delivery of the pulse signal, the present embodiment takes as an example the application of the pulse signal by the pulse ablation device 100 in ST segment 202.

Fig. 7 is a schematic diagram of applying a pulse signal in the ST segment in this embodiment. As shown in FIG. 7, the cardiac signal of the patient includes a first cardiac cycle 200a and a second cardiac cycle 200 b. In each cardiac cycle (200a, 200b), t after each R-wave peak_pThe pulse signal starts to be applied after ms (hereinafter referred to as "start delay time period"), and therefore, the timing of applying the pulse signal is controlled by the start delay time period. Duration of t_qms (hereinafter "duration"), the end points of the first ST segment 202a and the second ST segment 202b represent the times at which the pulse signal starts and stops issuing in each cardiac cycle (200a, 200 b).

In one embodiment, t is for the first cardiac cycle 200a or the second cardiac cycle 200b_pAnd t_qAre the same, by simply averaging the characteristic parameters over several cardiac cycles prior to application of the pulse signal. Thus, assuming that the pulse duration preset in step S05 is t ms, at t/t_qAfter one cardiac cycle, the pulse ablation operation of the current part to be ablated is completed. In this mode, each cardiac cycleThe position of the peak value of the R wave only needs to be detected in the period. This mode is simple to implement, but once a premature beat occurs during the ablation or the morphology of the cardiac signal within a certain cardiac cycle changes significantly, it may cause the pulse signal to fall outside the effective refractory period of the cardiomyocytes at the non-arrhythmic origin, and there is a certain risk of surgery.

In another embodiment, t is for the first cardiac cycle 200a or the second cardiac cycle 200b_pAnd t_qIs determined according to the detection result of the characteristic parameter of the current cardiac cycle. I.e. t_pIs a value from the time T of the peak value of the R wave of the current cardiac cycle_ABy time T when the S-wave valley returns to the baseline voltage level (203 in the figure)_BTime difference between t_qAt the time T when the S-wave valley returns to the baseline voltage level_BBy time T before the T-wave when the voltage value crosses the baseline voltage level_CThe time difference between them. Thus, assuming that the pulse duration preset in step S05 is t ms, when the total time of applying the pulsed electric field in a plurality of consecutive cardiac cycles exceeds t ms, the pulse ablation operation of the current ablation site is completed. In this mode, the time of the peak of the R wave, the time of the valley of the S wave returning to the baseline voltage level, and the time of the voltage value before the T wave crossing the baseline voltage level are detected for each cardiac cycle. The mode can adjust the pulse signal sending time according to the characteristic parameters of the electrocardiosignal in each cardiac cycle, and is more specific.

In another embodiment, T_AAt the time of the peak of the R wave, T_BT is the time after the S wave valley is recovered to the baseline voltage level for a certain time_CThe time before the T wave after the voltage value crosses the base line voltage level for a certain time/a certain amplitude.

More preferably, for t_pAnd t_qThe value of (c) sets a certain threshold range. For example, in each cardiac cycle, an upper threshold t for the duration of the pulsed electric field is set_mms, then the duration t of the pulse signal in a certain cardiac cycle_q>t_mAt that time, even if the voltage value of the electrocardiosignal at that time does not reach the endThe delivery criteria (crossing the baseline voltage level before the T-wave) will also cause the processor module 130 to control the pulsed electric field generation module 120 to temporarily stop delivering the pulsed signal.

Of course, in other embodiments, the cardiac signal in each cardiac cycle fluctuates greatly, and the baseline voltage level can be determined according to the prior art, which is not limited in the present invention.

Therefore, the processor module 130 determines the average value of the initial delay duration and the duration according to the electrocardiosignals in a plurality of cardiac cycles before the pulse signal is applied to the to-be-ablated part, so as to uniformly set the time and the duration of the pulse signal applied to the to-be-ablated part. In addition, the processor module 130 may also determine the initial delay duration and the duration in each cardiac cycle according to the characteristic parameters of the electrocardiographic signal in each cardiac cycle, and specifically adjust the time and duration for applying the pulse signal to the ablation site. Therefore, the user of the system can select the two modes according to the judgment on the stability of the electrocardiosignals of the patient, thereby further improving the efficiency and the safety of the operation.

Based on the same inventive concept, the invention also provides a control pulse ablation method, which comprises the following steps: and generating a control signal according to the rhythm type, wherein the control signal comprises the sending time of the pulse signal, and different rhythm types correspond to different sending times of the pulse signal. The pulse signal releases a pulse electric field through the electrode, and the pulse electric field acts on a part to be ablated to implement pulse ablation.

Further, the pulse signal delivery timing is set to be within a specific time period of each cardiac cycle of the electrocardiographic signal.

Further, the pulse signal issuing time comprises the time and duration of applying the pulse signal; the time of applying the pulse signal is controlled by an initial delay time length, the initial delay time length refers to the time of delaying the pulse signal after the characteristic parameter occurs, and the time of applying the pulse signal is after the initial delay time length; the duration refers to the duration of the pulse signal in each of the cardiac cycles.

Optionally, according to the electrocardiographic signals in a plurality of cardiac cycles, an average value of the initial delay time and the duration is determined, so as to uniformly set the time of applying the pulse signal to the portion to be ablated and the duration.

Optionally, the initial delay duration and the duration in each cardiac cycle are determined according to a characteristic parameter of an electrocardiographic signal in each cardiac cycle, so as to set the time when a pulse signal is applied to a region to be ablated and the duration respectively.

Further, the control signal comprises pulse signal parameters, and the electrocardiosignal comprises a P wave, a QRS wave group and a T wave; the characteristic parameters of the electrocardiosignal comprise the starting time, the peak time and/or the ending time of a P wave, an R wave and a T wave, wherein the R wave is a wave in a QRS complex, the time period from the end point of the P wave to the start point of the QRS complex is the PQ segment of the cardiac cycle, the time period from the end point of the QRS complex to the start point of the T wave is the ST segment of the cardiac cycle, and the specific time period comprises the PQ segment and the ST segment.

Further, the types of heart rhythms include abnormal heart rhythms and normal heart rhythms, and the abnormal heart rhythms include supraventricular arrhythmias and ventricular arrhythmias. When the type of rhythm is supraventricular arrhythmia, the pulse signal delivery timing is set to be within the PQ segment of each of the cardiac cycles; when the rhythm types are ventricular arrhythmia and normal rhythm, the pulse signal delivery timing is set to be located in the ST segment of each cardiac cycle.

Based on the same inventive concept, the present invention also provides a computer-readable storage medium, on which a computer program is stored which, when being executed by a processor, carries out the method of controlling impulse ablation.

It will be appreciated that the memory in embodiments of the invention may be either volatile memory or nonvolatile memory, or may include both volatile and nonvolatile memory. The nonvolatile memory may be a read-only memory (ROM), a Programmable ROM (PROM), an Erasable PROM (EPROM), an Electrically Erasable PROM (EEPROM), or a flash memory. Volatile memory can be Random Access Memory (RAM) which acts as external cache memory. By way of example and not limitation, many forms of Random Access Memory (RAM) are available, such as Static RAM (SRAM), Dynamic Random Access Memory (DRAM), Synchronous DRAM (SDRAM), double data rate SDRAM (DDR SDRAM), enhanced SDRAM (enhanced SDRAM), SDRAM (SLDRAM), synchlink DRAM (SLDRAM), and direct bus RAM (DR RAM).

A Graphical User Interface (GUI) displayed on the lower display 133 will be described.

Fig. 8 is a graphical user interface in the present embodiment. As shown in FIG. 8, the impulsive ablation device 100 presents a control interface and the results of the analysis by the central processor 132 to the system user via a graphical user interface GUI of the display 133. The graphical user interface GUI includes first to fifth functional areas.

The first functional region b1 is used for operation by a system user, and can select the electrode 111 number for applying a pulse electric field through a pull-down list, wherein the electrode 111 numbers respectively include an anode electrode number 111A and a cathode electrode number 111C for convenience of description. While the shape of the currently used interventional device 110 is shown alongside and the respective electrodes 111 and their respective numbering are plotted on the interventional device 110. Preferably, after the anode electrode 111A and the cathode electrode 111C are numbered, the set anode electrode 111A and the set cathode electrode 111C are respectively marked on the interventional device 110 by a color different from the other electrodes 111 to show the difference. For example, the anode electrode 111A is marked with red, the cathode electrode 111C is marked with blue, and the other electrodes 111 are marked with black.

The second functional region b2 is used for setting pulse signal parameters including pulse polarity, pulse voltage, pulse width, pulse duty ratio, pulse duration and the like. The parameters can be preset by the system, and the user of the system can edit and adjust the parameters according to own experience.

The third functional region b3 is used to set the timing of the delivery of the pulsed electric field. The method comprises the following setting items:

type of heart rhythm: three types including supraventricular arrhythmia, ventricular arrhythmia and normal heart rate; it should be appreciated that the type of heart rhythm may be derived from the analysis of the characteristic parameters of the electrocardiosignal by the CPU 132, or may be manually set by the user of the system, as previously described;

initial wave form: is used for setting the characteristic parameters of a certain electrocardiosignal to be detected in each cardiac cycle, the characteristic parameters of the electrocardiosignal are used for controlling the starting and sending time of the pulse signal, and the time corresponds to the time T in the figure 7_A. If the "heart rhythm type" is ventricular arrhythmia as shown in fig. 8, then the "starting wave pattern" may be set to "R-wave", i.e. the R-wave peak instant in each cardiac cycle is detected.

Start delay period: setting the length of time for delaying the emission of the pulse signal after the onset waveform occurs, corresponds to the parameter t in fig. 7_p: i.e. t set at the position of the peak of the R-wave in each cardiac cycle_pAfter ms the application of the pulse signal is started.

Duration: the duration of the pulse signal in each cardiac cycle is set, corresponding to the parameter t in fig. 7_q: i.e. setting the duration t after the pulse signal is applied in each cardiac cycle_qAfter ms the delivery of the pulse signal is stopped until the next cardiac cycle.

Applied time: the sum of the pulse signal durations in all cardiac cycles for which a pulse signal is delivered is used to indicate that this term is read-only and cannot be edited.

The fourth functional area b4 is used for displaying the ecg signals transmitted by the ecg signal acquiring module 140 in real time. The electrocardiogram signal display device can be a body surface standard I lead, a body surface standard II lead and can simultaneously display the electrocardiogram signals of a plurality of leads. Typically, the detection results of the processor module 130, such as the detection results for the starting waveform (see dots in the figure), are identified on the cardiac signal waveform. Statistical information (not shown) such as the heart rate of the patient is also typically displayed in the blank area.

The fifth functional area b5 is the control interaction area of the processor module 130 to the pulsed electric field generation module 120, and mainly comprises two control buttons.

The "start" button functions as: after the system user confirms that the setting of the electrode 111 in the first functional area b1, the setting of the pulse signal parameters in the second functional area b2 and the setting of the pulse signal sending timing in the third functional area b3 are correct, clicking the "start" button can control the pulse electric field generating module 120 to continuously send the pulse signal in a specific time period of each cardiac cycle according to a preset mode, and simultaneously, the column of the "applied time" in the third functional area b3 is continuously timed after being set to zero, so as to display the sum of the pulse signal duration in all cardiac cycles.

The "end" button functions as: the pulsed electric field generation module 120 can be controlled to stop sending the pulse signal by clicking the button once any accident or error occurs during the operation.

Of course, the start and stop and related parameters can also be controlled by directly operating the control panel of the pulsed electric field generation module 120. In addition, in addition to stopping the application of the pulse electric field by the "end" button, in other embodiments, it may be set to automatically end the application of the pulse electric field when the "applied time" in the third functional region b3 is higher than the "pulse duration" set in the second functional region b 2.

It should be noted that the layout of the graphical user interface is not fixed, and the content displayed in the figure (such as the shape of the interventional device 110 or the number of the electrodes 111) is not fixed, and may be adjusted according to the actual need, which is not limited by the present invention.

For a better understanding of the pulse ablation system of the present invention, the procedure used in the pulse ablation system of the present embodiment is described below with reference to fig. 9, and specifically as follows:

step S1: the procedure is initiated by passing the distal end of the interventional device 110 through a vascular access to the renal artery 310.

Step S2: the distal end of the interventional device 110 is moved back and forth within the renal artery 310 and stimulation signals are applied to determine the site within the renal artery 310 to be ablated.

Step S3: the electrocardiosignal acquisition module 140 acquires electrocardiosignals of a patient and then sends the electrocardiosignals to the processor module 130. Processor module 130 detects characteristic parameters of the cardiac electrical signal and obtains the type of heart rhythm of the patient. The processor module 130 then issues control signals to the pulsed electric field generation module 120 based on the type of patient's heart rhythm and other external conditions.

Step S4: after receiving the control signal from the processor module 130, the pulsed electric field generating module 120 will continuously start/stop generating the pulse signal with the specified parameters according to the control signal until the specified total pulse duration is reached.

Step S5: and after the pulse electric field is applied according to the specified pulse duration, whether the current part finishes ablation needs to be confirmed. The specific judgment method may be similar to the method when the site to be ablated is determined previously. If the ablation is not thorough, the pulsed electric field needs to be applied again, and the operation is repeated until the ablation of the current part is successful.

Step S6: and then, if other parts to be ablated exist, repeating the operation process until all the parts to be ablated are ablated, and finishing the operation.

It should be noted that the above steps are not mandatory to be performed sequentially, and that there may be cases of parallel operation between the steps. For example, the operation of acquiring the cardiac electrical signal of the patient in step S3 may be performed immediately after the start of the operation.

Although the present invention is exemplified by a renal artery sympathetic nerve impulse ablation technology, those skilled in the art will appreciate that the present invention can also be applied to other sites or other fields of impulse ablation technology, and also can be applied to non-ablative impulse therapy technology, and the technical concept of the present invention can be applied as long as the timing of delivering the impulse electric field is determined according to the type of the heart rhythm, and only structural adaptation is required. The invention is not only applicable to the human body but also to other animal bodies, and is not limited in this respect as it is encompassed by the claims.

The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention in any way. It will be understood by those skilled in the art that various changes, substitutions and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims.

Claims

1. A pulse ablation device, comprising:

the pulse electric field generating module is used for outputting a pulse signal according to the control signal, the pulse electric field generating module is used for being connected with an intervention device, an electrode is configured on the intervention device, and the pulse signal acts on a part to be ablated through the electrode to implement pulse ablation.

2. The pulse ablation device according to claim 1, wherein said control signal includes pulse signal delivery timings, wherein different ones of said rhythm types correspond to different ones of said pulse signal delivery timings, said pulse signal delivery timings being configured to be within a specified time period of each cardiac cycle of the cardiac electrical signal.

3. The pulse ablation device according to claim 2, further comprising an electrocardiographic signal acquisition module for acquiring electrocardiographic signals, wherein the processor module receives the electrocardiographic signals, obtains the rhythm type according to the characteristic parameters of the electrocardiographic signals, and determines the pulse signal delivery time according to the rhythm type.

4. The pulse ablation device according to claim 3, wherein the processor module is configured to continuously update the control signal based on the continuously received cardiac electrical signal and output the updated control signal to the pulsed electric field generation module.

5. The pulse ablation device of claim 2, further comprising an input module for inputting the rhythm type, the processor module determining the pulse signal delivery timing based on the rhythm type.

6. The pulse ablation device of claim 2, wherein the control signal comprises a pulse signal parameter; after the processor module sets the pulse signal issuing opportunity and the pulse signal parameters, the processor module issues the control signal to the pulse electric field generation module, and the control signal controls the pulse electric field generation module to continuously generate pulse signals with preset parameters in a specific time period of each cardiac cycle.

7. The pulse ablation device of claim 2, wherein the cardiac signal comprises a P-wave, a QRS complex, and a T-wave; the characteristic parameters of the electrocardiosignal comprise the starting time, the peak time and/or the ending time of a P wave, an R wave and a T wave, wherein the R wave is a wave in a QRS complex, the time period from the end point of the P wave to the start point of the QRS complex is the PQ segment of the cardiac cycle, the time period from the end point of the QRS complex to the start point of the T wave is the ST segment of the cardiac cycle, and the specific time period comprises the PQ segment and the ST segment.

8. The pulse ablation device of claim 7, wherein the heart rhythm types include abnormal heart rhythms and normal heart rhythms, the abnormal heart rhythms including supraventricular arrhythmias and ventricular arrhythmias;

9. The pulse ablation device of claim 7, wherein the pulse signal delivery timing comprises a time and duration of application of a pulse signal; the time of applying the pulse signal is controlled by an initial delay time length, the initial delay time length refers to the time of delaying the pulse signal after the characteristic parameter occurs, and the time of applying the pulse signal is after the initial delay time length; the duration refers to the duration of the pulse signal in each of the cardiac cycles.

10. The pulse ablation device according to claim 9, wherein the processor module determines an average of the start delay period and the duration period from the cardiac electrical signal over a plurality of cardiac cycles before applying the pulse signal to the site to be ablated to uniformly set the timing of applying the pulse signal and the duration period.

11. The pulse ablation device according to claim 9, wherein the processor module determines the start delay period and the duration period in each of the cardiac cycles based on a characteristic parameter of the cardiac electrical signal in each of the cardiac cycles to set the time instant and the duration period at which the pulse signal is applied, respectively.

12. The pulse ablation device of claim 9, wherein the time of application of the pulsed signal in the PQ segment of each cardiac cycle is within 30ms to 55ms after the peak value of the P-wave, and the duration is within 50ms to 75 ms; and/or the presence of a gas in the gas,

13. The pulse ablation device according to claim 1, further comprising a stimulation module for generating a stimulation signal to be applied to a target object via the interventional device for determining the site to be ablated.

14. The pulse ablation device of claim 13, wherein the processor module further comprises a display for displaying a steering interface and results of the analysis by the central processor; the pulse signal generation module also comprises a control panel, and the pulse signal parameters can be remotely controlled through the control interface and/or controlled through the control panel.

15. A pulse ablation system, comprising:

the pulse ablation device as in claims 1-14;

16. A method of controlled pulse ablation, the method comprising: and generating a control signal according to the rhythm type, wherein the control signal comprises the sending time of the pulse signal, and different rhythm types correspond to different sending times of the pulse signal.

17. The method of controlled pulse ablation according to claim 16, wherein the pulse signal delivery timing is set to be within a specified time period of each cardiac cycle of the cardiac electrical signal.

18. The method of controlled pulse ablation according to claim 17, wherein the pulse signal delivery timing comprises the time and duration of application of the pulse signal; the time of applying the pulse signal is controlled by an initial delay time length, the initial delay time length refers to the time of delaying the pulse signal after the characteristic parameter occurs, and the time of applying the pulse signal is after the initial delay time length; the duration refers to the duration of the pulse signal in each of the cardiac cycles.

19. The method of controlled pulse ablation according to claim 18, wherein an average of said start delay period and said duration period is determined based on the cardiac electrical signals in a plurality of said cardiac cycles to uniformly set said timing of applying the pulse signal and said duration period of said site to be ablated; or the like, or, alternatively,

and determining the initial delay time length and the duration time length in each cardiac cycle according to the characteristic parameters of the electrocardiosignals in each cardiac cycle so as to respectively set the pulse signal applying time and the duration time length of the part to be ablated.

20. The method of controlled pulse ablation according to claim 17, wherein said control signals include pulse signal parameters, said cardiac signal including a P-wave, a QRS complex, and a T-wave; the characteristic parameters of the electrocardiographic signal comprise the starting time, the peak time and/or the ending time of a P wave, an R wave and a T wave, wherein the R wave is a wave in a QRS complex, the time period from the end point of the P wave to the start point of the QRS complex is the PQ segment of the cardiac cycle, the time period from the end point of the QRS complex to the start point of the T wave is the ST segment of the cardiac cycle, and the specific time period comprises the PQ segment and the ST segment.

21. The method of controlled pulse ablation according to claim 20, wherein the heart rhythm types include abnormal heart rhythms and normal heart rhythms, the abnormal heart rhythms including supraventricular arrhythmias and ventricular arrhythmias;

when the type of rhythm is supraventricular arrhythmia, the pulse signal delivery timing is set to be within the PQ segment of each of the cardiac cycles;

22. A computer-readable storage medium, on which a computer program is stored which, when being executed by a processor, carries out a method of controlling pulsed ablation according to any one of claims 16-21.