Pulse ablation device, system, control method and readable storage medium

Abstract

The present invention provides a pulse ablation device for performing pulse ablation on a patient's part to be ablated. The pulse ablation device includes a processor module for outputting a control signal according to the patient's heart rhythm type; a pulse electric field generating module for outputting a pulse signal according to the control signal, and the pulse electric field generating module is used to be connected to an interventional device, and the interventional device is provided with electrodes, and the pulse signal acts on the part to be ablated through the electrodes to perform pulse ablation. The present invention provides a pulse ablation system, which also includes an interventional device, and an electrode is provided at the far end, and the electrode uses the pulse signal to apply a pulse electric field to the part to be ablated. In the pulse ablation system, since the processor module can determine the timing of applying the pulse electric field according to the heart rhythm type of different patients, it can minimize the impact of the pulse electric field on the patient's normal heart rhythm, so as to improve the safety of the operation.

Description

Technical Field

[0001] The present invention relates to the field of medical device technology, and in particular to a pulse ablation device, system, control method and readable storage medium. Background Art

[0002] Renal artery sympathetic nerve ablation is an important research direction for the treatment of refractory hypertension. Currently, radiofrequency ablation or cryoablation is commonly used to ablate the renal artery sympathetic nerves. Both ablation methods are based on thermal effects and will cause indiscriminate damage to the ablation target and healthy tissues around the target, such as blood vessels and fat. Therefore, if the ablation energy is not well controlled, it is easy to cause various complications, such as renal artery perforation, renal artery stenosis or occlusion, and renal artery dissection. In addition, the renal artery sympathetic nerves are distributed around the renal artery, and the renal artery has many branches. Due to the volume limitation of catheters (such as balloon catheters), the ablation treatment of the renal artery branch nerves is not yet in-depth.

[0003] Pulse ablation can also be used to ablate the renal artery sympathetic nerves. When pulse ablation is used for ablation treatment, the pulse ablation system applies intermittent high-intensity, narrow pulse electric fields to the tissue to be ablated, which will cause micropores in the cell membrane of tissue cells and increase the permeability of the cell membrane. When the intensity of the pulse electric field reaches a certain level, irreparable large perforations will appear on the cell membrane. This process is called irreversible electroporation, which leads to cell apoptosis. Since different types of tissue cells have different tolerance to pulse electric fields, when pulse electric fields are applied to ablation treatment, selecting specific pulse electric field parameters can achieve the effect of destroying specific cells and tissues to be ablated. In addition, pulse ablation is short in implementation time and is not based on thermal effects, which can further reduce damage to surrounding healthy tissues. Therefore, pulse ablation has also been widely used in the ablation treatment of organs such as the heart and various tumors.

[0004] Although pulse ablation has the above advantages, the pulse electric field during pulse ablation can easily cause abnormal cardiac electrical activity in patients, easily leading to myocardial tremor and abnormal heart rate. Especially for patients with refractory hypertension, according to clinical statistics, most of them have different degrees and types of arrhythmias. For such patients, the function of myocardial cells at the origin of arrhythmias is more easily disturbed by external stimuli, which may lead to more chaotic electrical activity, greatly affecting the safety of pulse ablation surgery. Summary of the invention

[0005] The purpose of the present invention is to provide a pulse ablation device, system, control method and readable storage medium, which can determine the timing of applying a pulse electric field according to the heart rhythm type of different patients, reduce the impact of pulse ablation on the patient's normal heart rhythm, and improve the safety of the operation.

[0006] In order to achieve the above object, the present invention provides a pulse ablation device, comprising:

[0007] a processor module, configured to output a control signal according to the heart rhythm type; and

[0008] The pulse electric field generating module is used to output a pulse signal according to the control signal. The pulse electric field generating module is used to be connected to an interventional device, and the interventional device is provided with electrodes. The pulse signal acts on the part to be ablated through the electrodes to implement pulse ablation.

[0009] Optionally, the control signal includes a pulse signal issuing timing, wherein different heart rhythm types 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 electrocardiogram signal.

[0010] Optionally, the pulse ablation device also includes an ECG signal acquisition module for acquiring ECG signals. The processor module receives the ECG signals, obtains the heart rhythm type based on characteristic parameters of the ECG signals, and determines the timing of issuing the pulse signal based on the heart rhythm type.

[0011] Optionally, the processor module is used to continuously update the control signal according to the continuously received electrocardiogram signal and output the updated control signal to the pulse electric field generating module.

[0012] Optionally, the pulse ablation device further includes an input module for inputting the heart rhythm type, and the processor module determines the timing of issuing the pulse signal according to the heart rhythm type.

[0013] Optionally, the control signal includes pulse signal parameters; after the processor module sets the pulse signal emission timing and the pulse signal parameters, the processor module emits the control signal to the pulse electric field generating module, and the control signal controls the pulse electric field generating module to continuously generate a pulse signal with preset parameters within a specific time period of each cardiac cycle.

[0014] Optionally, the ECG signal includes a P wave, a QRS complex and a T wave; the characteristic parameters of the ECG signal include the starting time, peak time and / or ending time of the P wave, R wave and T wave, wherein the R wave is a wave in the QRS complex, the time period between the end point of the P wave and the starting point of the QRS complex is the PQ segment of the cardiac cycle, the time period between the end point of the QRS complex and the starting point of the T wave is the ST segment of the cardiac cycle, and the specific time period includes the PQ segment and the ST segment.

[0015] Optionally, the heart rhythm type includes abnormal heart rhythm and normal heart rhythm, and the abnormal heart rhythm includes supraventricular arrhythmia and ventricular arrhythmia;

[0016] When the heart rhythm type is supraventricular arrhythmia, the pulse signal emission timing is set to be located within the PQ segment of each cardiac cycle; and / or

[0017] When the heart rhythm type is ventricular arrhythmia and normal heart rhythm, the pulse signal issuance timing is set to be within the ST segment of each cardiac cycle.

[0018] Optionally, the timing of pulse signal emission includes the moment and duration of applying the pulse signal; the moment of applying the pulse signal is controlled by the starting delay duration, the starting delay duration refers to the time for delaying the emission of the pulse signal after the occurrence of the characteristic parameter, and the moment of applying the pulse signal is after the starting delay duration; the duration refers to the duration of the pulse signal in each cardiac cycle.

[0019] Optionally, the processor module determines the average value of the start delay time and the duration based on the electrocardiogram signals in multiple cardiac cycles before applying the pulse signal to the ablation site, so as to uniformly set the moment of applying the pulse signal and the duration.

[0020] Optionally, the processor module determines the start delay duration and the duration in each cardiac cycle based on characteristic parameters of the electrocardiogram signal in each cardiac cycle, so as to respectively set the moment of applying the pulse signal and the duration.

[0021] Optionally, the pulse signal is applied within the PQ segment of each cardiac cycle within 30ms to 55ms after the peak of the P wave, and the duration is 50ms to 75ms; and / or,

[0022] The time of applying the pulse signal in the ST segment of each cardiac cycle is within 50ms to 75ms after the peak value of the R wave, and the duration is 80ms to 150ms.

[0023] Optionally, the pulse ablation device further includes a stimulation module for generating a stimulation signal, wherein the stimulation signal acts on the target object through the intervention device, thereby determining the site to be ablated.

[0024] Optionally, the processor module also includes a display for displaying a control interface and analysis results of the central processing unit; the pulse signal generating module also includes a control panel, and the pulse signal parameters can be remotely controlled through the control interface and / or controlled through the control panel.

[0025] In addition, the present invention also provides a pulse ablation system, comprising:

[0026] The pulse ablation device;

[0027] An interventional device is used to be connected to the pulse ablation equipment. An electrode is provided at the distal end of the interventional device. The pulse signal acts on the part to be ablated through the electrode to implement pulse ablation.

[0028] In addition, the present invention also provides a controlled pulse ablation method, comprising: generating a control signal according to the heart rhythm type, the control signal including a pulse signal issuance timing, wherein different heart rhythm types correspond to different pulse signal issuance timings. Optionally, the pulse signal issuance timing is set to be within a specific time period of each cardiac cycle of the electrocardiogram signal.

[0029] Optionally, the timing of pulse signal emission includes the moment and duration of applying the pulse signal; the moment of applying the pulse signal is controlled by the starting delay duration, the starting delay duration refers to the time for delaying the emission of the pulse signal after the occurrence of the characteristic parameter, and the moment of applying the pulse signal is after the starting delay duration; the duration refers to the duration of the pulse signal in each cardiac cycle.

[0030] Optionally, according to the electrocardiogram signals in a plurality of cardiac cycles, an average value of the start delay time and the duration time is determined to uniformly set the time of applying the pulse signal and the duration time of the part to be ablated; or,

[0031] The start delay time and the duration time in each cardiac cycle are determined according to characteristic parameters of the electrocardiogram signal in each cardiac cycle, so as to respectively set the time for applying the pulse signal and the duration time in the part to be ablated.

[0032] Optionally, the control signal includes pulse signal parameters, and the ECG signal includes P wave, QRS complex and T wave; the characteristic parameters of the ECG signal include the starting time, peak time and / or end time of the P wave, R wave and T wave, wherein the R wave is a wave in the QRS complex, the time period between the end point of the P wave and the starting point of the QRS complex is the PQ segment of the cardiac cycle, the time period between the end point of the QRS complex and the starting point of the T wave is the ST segment of the cardiac cycle, and the specific time period includes the PQ segment and the ST segment.

[0033] Optionally, the heart rhythm type includes abnormal heart rhythm and normal heart rhythm, and the abnormal heart rhythm includes supraventricular arrhythmia and ventricular arrhythmia;

[0034] When the heart rhythm type is supraventricular arrhythmia, the pulse signal emission timing is within the PQ segment of each cardiac cycle;

[0035] When the heart rhythm type is ventricular arrhythmia and normal heart rhythm, the pulse signal emission timing is located within the ST segment of each cardiac cycle.

[0036] In addition, the present invention also provides a computer-readable storage medium on which a computer program is stored, and when the program is executed by a processor, the controlled pulse ablation method is implemented.

[0037] The pulse ablation device provided by the present invention is used to perform pulse ablation on the patient's part to be ablated, and the pulse ablation device includes a processor module and a pulse electric field generating module. The processor module is used to output a control signal according to the patient's heart rhythm type, and the pulse electric field generating module is used to output a pulse signal according to the control signal. The pulse electric field generating module is used to be connected to an interventional device, and the interventional device is provided with electrodes. The pulse signal acts on the part to be ablated through the electrodes to perform pulse ablation. The pulse ablation device can determine the timing of applying the pulse electric field according to the heart rhythm type of different patients, so as to reduce the impact on the patient's normal heart rhythm, thereby improving the safety of the operation.

[0038] The pulse ablation device also includes an ECG signal acquisition module for acquiring the patient's ECG signal. The processor module receives the ECG signal, obtains the patient's heart rhythm type based on characteristic parameters of the ECG signal, and outputs a control signal based on the heart rhythm type.

[0039] Accordingly, the present invention provides a pulse ablation system, which uses the pulse ablation device and also includes an interventional device, the proximal end of which is connected to the pulse ablation device, and the distal end 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, thereby causing an irreversible electroporation effect in the part to be ablated of the patient. Since the processor module can determine the timing of applying the pulse electric field according to the heart rhythm type of different patients, it can minimize the impact of the pulse electric field on the normal heart rhythm of the patient. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] Figure 1 It is a structural block diagram of the pulse ablation system in an embodiment of the present invention applied to renal artery treatment;

[0041] Figure 2 is a schematic diagram of the kidney structure and the position of the interventional device in the renal artery in an embodiment of the present invention;

[0042] Figure 3Schematic diagram of a single-phase pulse signal waveform in an embodiment of the present invention;

[0043] Figure 4 Schematic diagram of a biphase pulse signal waveform in an embodiment of the present invention;

[0044] Figure 5 is a schematic diagram of a typical waveform of a body surface electrocardiogram signal in one cardiac cycle in an embodiment of the present invention;

[0045] Figure 6 A flowchart of the operation of the processor module in an embodiment of the present invention;

[0046] Figure 7 A schematic diagram of applying a pulse electric field to the ST segment in an embodiment of the present invention;

[0047] Figure 8 A graphical user interface in an embodiment of the present invention;

[0048] Fig. 9 is a flow chart of the use of the pulse ablation system in an embodiment of the present invention;

[0049] The reference numerals are as follows:

[0050] 100-pulse ablation device; 110-intervention device; 111-electrode; 120-pulse electric field generating module; 130-processor module; 131-memory; 132-central processing unit; 133-display; 134-control circuit; 140-ECG signal acquisition module;

[0051] 200-cardiac cycle; 200a-first cardiac cycle; 200b-second cardiac cycle; 201-PQ segment; 202-ST segment; 202a-first ST segment; 202b-second ST segment;

[0052] 300-surgical object; 310-renal artery; 320-abdominal aorta; 330-kidney;

[0053] a1 - first information flow; a2 - second information flow; a3 - third information flow; a4 - fourth information flow; a5 - fifth information flow. DETAILED DESCRIPTION

[0054] The specific implementation of the present invention will be described in more detail below in conjunction with the schematic diagram. The advantages and features of the present invention will become clearer based on the following description. It should be noted that the drawings are all in a very simplified form and are not in exact proportions, and are only used to facilitate and clearly assist in explaining the purpose of the embodiments of the present invention.

[0055] In this article, the terms "proximal" and "distal" refer to the relative orientation, relative position, and direction of components or actions relative to each other from the perspective of a doctor using the medical device. Although "proximal" and "distal" are not restrictive, "proximal" usually refers to the end of the medical device that is close to the doctor during normal operation, and "distal" usually refers to the end that first enters the patient's body.

[0056] During the pulse ablation procedure, the high-intensity (high-voltage) pulsed electric field will change the cell membrane potential after acting on the cells of the tissue to be ablated, causing the cell membrane to be in a polarized state. After the polarization trend is rapidly transmitted along the adjacent cells to the heart, it will greatly interfere with the depolarization and repolarization of the myocardial cells, leading to abnormal cardiac electrical activity.

[0057] Cardiac electrical activity refers to the phenomenon that myocardial cells generate and conduct action potentials. During this process, myocardial cells along the direction of excitation propagation will undergo two processes, depolarization and repolarization, in sequence. When the depolarization and repolarization functions of myocardial cells in certain parts are abnormal, resulting in a disorder in normal cardiac electrical activity, the patient is considered to have arrhythmia. In addition, in the action potential time course of myocardial cells, from the beginning of zero-phase depolarization to the period when the membrane potential repolarizes to a certain degree, even if a strong stimulus is given, no action potential can be generated. This period of time is called the effective refractory period of myocardial cells. At present, in clinical practice, it is generally chosen to apply a pulsed electric field within the effective refractory period of the ventricular muscle.

[0058] However, according to clinical statistics, the incidence of arrhythmias in patients with hypertension is significantly increased. Most patients with refractory hypertension have arrhythmias of varying degrees and types. Therefore, during the pulse ablation procedure in patients with hypertension, myocardial tremor and abnormal heart rate are more likely to be induced.

[0059] Based on this, a pulse ablation device and system are provided in this embodiment for performing pulse ablation on the patient's to-be-ablated area, and determining the timing of applying the pulse electric field according to the patient's heart rhythm type, thereby minimizing the impact of the pulse electric field on the patient's heart rhythm and improving the safety of the operation.

[0060] The present invention is described using renal artery sympathetic nerve pulse ablation as an example, but the pulse ablation device and system of the present invention are not limited to the ablation of renal artery sympathetic nerves, but can also be used for ablation surgeries in other parts or other medical fields, such as pulmonary vein ablation, etc. The present invention does not impose any limitation on this.

[0061] Please refer to Figure 1 and Figure 2 , Figure 1 is a structural block diagram of the pulse ablation system in this embodiment applied to renal artery treatment, Figure 2FIG. 1 is a schematic diagram of the kidney structure and the position of the interventional device 110 in the renal artery in this embodiment. Figure 1 As shown, the pulse ablation system includes: an intervention device 110 and a pulse ablation device 100. The intervention device 110 may include one or more catheters. The distal end of the intervention device 110 is provided with an electrode 111, and the proximal end of the intervention device 110 is connected to the pulse ablation device 100. The electrode 111 is used to apply a pulse electric field to the site to be ablated. Figure 2 As shown, the surgical object 300 is a kidney 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 respectively through the renal hilum. The renal artery sympathetic nerves are distributed around the renal artery 310, and they play an important role in regulating blood pressure. During the renal artery sympathetic nerve pulse ablation process, the intervention device 110 is inserted into the body through the femoral artery or radial (brachial) artery (not shown), and then reaches the renal artery 310 through the vascular access. The pulse signal generated by the pulse ablation device 100 acts on the renal artery 310 through the electrode 111 on the intervention device 110, causing the sympathetic nerves around the renal artery 310 to undergo cell apoptosis, thereby blocking the sympathetic nerves of the renal artery 310, and then achieving the purpose of treating hypertension.

[0062] In this embodiment, the interventional device 110 is equipped with at least one pair of electrodes 111, which can be used to apply energy to tissues and measure electrophysiological signals. The electrode 111 is a boss ring electrode, and its shape is a boss ring. The electrode 111 is usually made of a metal with good biocompatibility, 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 5mm. Of course, the present application does not limit the number, specific shape, material, diameter and length of the electrode 111, as long as it can meet the function of releasing pulse ablation energy in this application.

[0063] Optionally, the electrode 111 is also provided with a perfusion hole, and the interventional device 110 is provided with a perfusion cavity connected to the perfusion hole. During the ablation process, the system user can perfuse physiological saline into the to-be-ablated site through the perfusion cavity and the perfusion hole. In addition to applying a pulsed electric field, the electrode 111 can also be used to apply electrical stimulation to the renal artery 310 and measure electrical signals in the renal artery 310.

[0064] Several sensors may also be provided at the distal end of the interventional device 110, and the sensors may be one or more of a temperature sensor, a pressure sensor, and a magnetic field sensor. The data measured by these sensors are generally transmitted to the pulse ablation device 100 through the wire inside the interventional device 110 and used to assist in the implementation of the ablation surgery. In one embodiment, the sensor includes a temperature sensor, which can be used to monitor temperature changes during the ablation process to avoid excessive temperature due to prolonged application of a pulsed electric field, thereby causing vascular damage or blood clot formation; in another embodiment, the sensor includes a pressure sensor, which can be used to detect the degree of contact between the interventional device 110 and the vascular wall of the renal artery 310; in yet another embodiment, the sensor includes a magnetic field sensor, which can be used to determine the three-dimensional spatial position and direction of the interventional device 110 in the patient's body.

[0065] The proximal end of the interventional device 110 is also provided with an operating handle (not shown), and the system user can adjust the position and shape of the distal end of the interventional device 110 in the renal artery 310 by adjusting the operating handle. In terms of shape, the interventional device 110 in the renal artery 310 can be in a straight line, a spiral or a ring, or other possible shapes that are convenient for ablation (such as a balloon or a basket, etc.).

[0066] In one embodiment, the pulse ablation device 100 further includes a stimulation module (not shown in the figure) for generating a stimulation signal, which acts on a potential ablation site in the patient's body through the electrodes on the interventional device to confirm the ablation site of the patient. Figure 1 Taking the renal artery sympathetic nerve pulse ablation system shown in as an example, if the ablation site needs to be ablated, then when the electrode 111 transmits the stimulation signal, parameters such as blood pressure and heart rate will show an upward trend over time; if the ablation site does not need to be ablated, then when the electrode transmits the stimulation signal, parameters such as blood pressure and heart rate will not change significantly over time.

[0067] Continue to refer Figure 1The pulse ablation device 100 includes: a processor module 130 and a pulse electric field generating module 120, wherein the processor module 130 is used to output a control signal according to the patient's heart rhythm type, and the pulse electric field generating module 120 outputs a corresponding pulse signal according to the control signal. The pulse electric field generating module is connected to the intervention device 110, and the pulse signal acts on the part to be ablated through the electrode 111 on the intervention device 110 to achieve pulse ablation. The control signal includes a pulse signal issuance timing and a pulse signal parameter, wherein different heart rhythm types correspond to different pulse signal issuance timings, and the pulse signal issuance timing is set to be located within a specific time period of each cardiac cycle of the electrocardiogram signal. The pulse signal parameters include the electrode 111 number, pulse polarity, pulse voltage, pulse width, pulse duty cycle, and pulse duration. It should be understood that the electrode 111 is used to achieve pulse ablation of the part to be ablated based on a pulse electric field, and the electrode 111 converts the pulse signal into the pulse electric field. Pulse ablation is the application of a high-intensity pulsed electric field to the tissue to be ablated, thereby causing irreversible electroporation effect in the tissue to be ablated to achieve a destructive effect. Different types of tissue cells have different tolerances to pulsed electric fields. Selecting a pulse signal with specific parameters to implement pulse ablation can achieve the effect of destroying specific tissue to be ablated. It should be noted that in this embodiment, the site to be ablated is the sympathetic nerves distributed around the renal artery 310.

[0068] The various modules of the pulse ablation device 100 are introduced in detail below.

[0069] The pulse ablation device 100 may also be provided with an ECG signal acquisition module 140 for acquiring ECG signals of the patient. The processor module 130 is electrically connected to the ECG signal acquisition module 140, and the processor module 130 receives and processes the ECG signals, obtains the patient's heart rhythm type according to the characteristic parameters of the ECG signals, and determines the timing of the pulse signal emission according to the heart rhythm type.

[0070] More preferably, the processor module 130 continuously receives the ECG signal, continuously updates the control signal and outputs the updated control signal to the pulse electric field generating module 120 .

[0071] As an optional implementation, the ECG signal acquisition module 140 is not electrically connected to the processor module 130. The ECG signal acquisition module 140 acquires the patient's ECG signal and presents it to the system user in the form of an ECG. The system user determines the patient's heart rhythm type based on the characteristic parameters of the ECG signal. The pulse ablation device 100 also includes an input module (not shown in the figure) for the system user to input the patient's heart rhythm type. The processor module 130 determines the timing of the pulse signal issuance based on the heart rhythm type.

[0072] In the pulse ablation device 100 of the present invention, the processor module 130 processes the electrocardiogram signal and then sends a control signal to control the timing of the pulse electric field generating module 120 to generate a pulse signal. The pulse electric field generating module 120 applies a pulse electric field to the renal artery 310 through the electrode 111 on the intervention device 110, thereby causing an irreversible electroporation effect on the sympathetic nerves surrounding the renal artery 310. Since the processor module 130 can determine the timing of applying the pulse electric field according to the heart rhythm type of different patients, it can minimize the impact of the pulse electric field on the normal heart rhythm of the patient, thereby improving the safety of the operation.

[0073] Continue to refer to Figure 1 The processor module 130 includes a memory 131, a central processing unit 132, and a control circuit 134. The memory 131 is used to store various data required or generated during the operation of the pulse ablation device 100. The central processing unit 132 is used to analyze and process the data of the pulse ablation device 100. The control circuit 134 exchanges data with the ECG signal acquisition module 140 and the pulse electric field generation module 120. The information flow for data exchange between the processor module 130 and the ECG signal acquisition module 140 and the pulse electric field generation module 120 will be described in detail later.

[0074] The processor module 130 is generally a computer system, and the processor module 130 also includes a display 133, and the display 133 is used to display a control interface and the analysis results of the central processor 132. The processor module 130 generally also includes peripherals, such as a keyboard, a mouse, or a touch screen, for controlling the processor module 130.

[0075] Continue to refer to Figure 1The pulse electric field generating module 120 is used to generate a pulse signal with adjustable parameters. The pulse signal generated by the pulse electric field generating module 120 is applied to the renal artery 310 through the electrode 111 mounted on the intervention device 110 to implement pulse ablation. The pulse signal generated by the pulse electric field generating module 120 releases pulse ablation energy through the electrode 111 on the intervention 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.

[0076] The pulse signal parameters include the electrode 111 number, pulse polarity, pulse voltage, pulse width, pulse duty cycle and pulse duration. Pulse ablation is the application of a high-intensity pulse electric field to the tissue to be ablated, thereby causing an irreversible electroporation effect in the tissue to be ablated to achieve a destructive effect. Different types of tissue cells have different tolerances to pulse electric fields. Selecting a pulse signal with specific parameters to implement pulse ablation can achieve the effect of destroying specific tissue to be ablated.

[0077] It should be known that the pulse signal parameters can be pre-set in the processor module 130, and the pulse electric field generating module 120 can continuously generate a pulse signal with preset parameters in a specific time period of each cardiac cycle according to the control signal. It should be known that the pulse signal parameters can also be manually adjusted by the system user based on experience. In another implementation of this embodiment, the pulse electric field generating module 120 also includes a control panel, and the pulse signal parameters are controlled by the control panel. In another implementation of this embodiment, the pulse signal parameters are remotely controlled through the control interface of the processor module 130.

[0078] Furthermore, the pulse polarity is in two modes: single-phase pulse or bi-phase pulse. The pulse signals with different pulse polarities are further described below in conjunction with the accompanying drawings.

[0079] Figure 3 FIG. 1 is a schematic diagram of a single-phase pulse signal waveform in this embodiment. Figure 3 As shown, U represents the pulse voltage, t s represents the total duration of the applied pulse electric field (i.e., pulse duration), t c Represents the total duration of a complete pulse cycle (i.e. pulse width), t 1 Represents the power-on time within a pulse cycle, and the pulse duty cycle at this time is t 1 / t c .

[0080] Figure 4 FIG. 1 is a schematic diagram of a biphase pulse signal waveform in this embodiment. Figure 4 As shown, U represents the pulse voltage, t srepresents the total duration of the applied pulse electric field (i.e., pulse duration), t c Represents the total duration of a complete pulse cycle (i.e. pulse width), t 1 is the positive phase pulse width, t 2 is the negative phase pulse width, and the duty cycle at this time is (t 1 +t 2 ) / t c , usually t 1 Equal to t 2 .

[0081] Furthermore, the pulse polarity is preferably a biphasic pulse, the pulse voltage is preferably adjusted in the range of 0.4 kV to 15 kV, and the pulse width is preferably adjusted in the range of 0.1 us to 100 us. 1 or 2 The width adjustment range is 0.1us~100us.

[0082] Furthermore, the preferred adjustment range of the pulse duty cycle is 1% to 99%.

[0083] Continue to refer to Figure 1 , the ECG signal acquisition module 140 is used to collect ECG signals of the patient. In a preferred embodiment, the ECG signal acquisition module 140 is used to collect ECG signals on the patient's body surface. At this time, an electrode patch with good conductivity is attached to a specific part of the patient's body surface for collection and recording. In a conventional surface ECG examination, a limb lead electrode is usually placed on each of the four limbs, and 6 chest lead electrodes are placed on the chest.

[0084] In another optional embodiment, the ECG signal acquisition module 140 is used to collect electrical signals from the inner surface of the patient's heart. At this time, an interventional device 110 with sensing electrodes is generally used to enter the heart cavity through a vascular pathway for collection and recording. The interventional device 110 here mainly plays a mapping role. This step is easy to understand for ordinary technicians in this field, and will not be described in detail here. In addition, the ECG signal acquisition module 140 will perform various preprocessing on the collected ECG signals, such as notching, filtering, and analog-to-digital conversion. This step is easy to understand for ordinary technicians in this field, and will not be described in detail here.

[0085] The electrocardiogram signal acquisition module 140 can record the process of electrocardiogram signal conduction in the heart, so that the respective times of depolarization and repolarization of myocardial cells in different parts can be distinguished through the processor module 130.

[0086] Figure 5 Schematic diagram of a typical waveform of the surface electrocardiogram signal in this embodiment during a cardiac cycle. Figure 5As shown, the ECG signal includes P wave, QRS complex and T wave. The P wave reflects the depolarization process of the atrium, the QRS complex reflects the depolarization process of the ventricle, and the T wave reflects the repolarization process of the ventricle. The repolarization wave of the atrium is generally masked by the QRS complex. In a cardiac cycle 200, the PQ segment 201 represents the period from the end of the P wave to the start of the QRS complex; the ST segment 202 represents the period from the end of the QRS complex to the start of the T wave. As can be seen from the foregoing, the timing of the pulse signal emission is set to be located within a specific time period of each cardiac cycle of the ECG signal, and the specific time period includes the PQ segment and the ST segment.

[0087] Continue to refer to Figure 1 The processor module 130 is the core of the control and data processing of the pulse ablation device 100. Next, the information flow of data interaction between the processor module 130 and the ECG signal acquisition module 140 and the pulse electric field generation module 120 is introduced. The arrows of each information flow represent the direction of data transmission.

[0088] Continue to refer to Figure 1 , the first information stream a1 represents the ECG signal collected from the patient's body surface, which will be sent to the ECG signal acquisition module 140. The second information stream a2 represents the ECG signal after preprocessing (such as notching, filtering and analog-to-digital conversion) by the ECG signal acquisition module 140, which will enter the processor module 130 through the control circuit 134. The third information stream a3 represents the pulse signal generated by the pulse electric field generation module 120, and the pulse signal will be applied to the sympathetic nerves distributed around the renal artery 310 through the electrode 111 on the intervention device 110. The fourth information stream a4 represents the control signal sent by the processor module 130 to the pulse electric field generation module 120. The control signal includes two types: one refers to the timing of the pulse signal, which can be understood as the time points in the cardiac cycle 200 at which the pulse signal should be started or stopped. The other is the parameters of the applied pulse signal, including the number of the electrode 111 used to apply the pulse electric field, the pulse polarity, the pulse voltage, the pulse width, the pulse duty cycle, and the pulse duration. The fifth information flow a5 represents the signals collected by the electrodes 111 or sensors on the interventional device 110, such as voltage signals, temperature signals or pressure signals, etc. These signals will be transmitted to the processor module 130 through the control circuit 134 for subsequent analysis and processing.

[0089] The working process of the processor module 130 is described in detail below.

[0090] Figure 6 FIG. 1 is a flowchart of the operation of the processor module 130 in this embodiment. Figure 6 As shown, the process of the processor module 130 includes the following steps:

[0091] Step S01 : the processor module 130 receives the ECG signal of the patient acquired by the ECG signal acquisition module 140 .

[0092] Step S02: the processor module 130 detects the collected ECG signals and analyzes the characteristic parameters of the collected ECG signals in real time.

[0093] The characteristic parameters of the ECG signal include the start time, peak time and / or end time of the P wave, R wave and T wave. There are many ways for the processor module 130 to perform analysis on the characteristic parameters of the ECG signal. In one embodiment, the analysis is performed using the ECG signal of the body surface standard lead I. In another embodiment, the analysis is performed using the ECG signal of the body surface standard lead II. In other embodiments, the characteristic parameters of the ECG signal are detected using a dynamic differential threshold method or a method based on wavelet transform is used to detect the characteristic parameters of the ECG signal.

[0094] Step S03: the processor module 130 obtains the patient's heart rhythm type based on the analysis result of the characteristic parameters of the electrocardiogram signal.

[0095] The heart rhythm type includes: abnormal heart rhythm and normal heart rhythm, and the abnormal heart rhythm includes supraventricular arrhythmia and ventricular arrhythmia. The processor module 130 can obtain the patient's heart rhythm type based on the analysis results of the characteristic parameters of the electrocardiogram signal. In one implementation of the present embodiment, the processor module 130 uses a machine learning method to obtain the patient's heart rhythm type by analyzing the characteristic parameters of the electrocardiogram signal. Optionally, in other implementations, the system user can manually set the patient's arrhythmia type on the control interface based on his or her own experience. Optionally, the processor module 130 is used to obtain the patient's heart rhythm type, because the processor module 130 can display the patient's heart rhythm type in real time, prompt the system user of the patient's heart rhythm type, and avoid the patient's heart rhythm type changes during the operation being ignored, causing surgical safety hazards.

[0096] Step S04: According to the patient's heart rhythm type, the processor module 130 will give a suggested pulse signal issuance timing, which includes the time and duration of applying the pulse signal. The processor module 130 can determine the pulse signal issuance timing by itself, and the system user can also set the pulse signal issuance timing based on experience.

[0097] As mentioned above, the applicant has found through research that the function of myocardial cells at the origin of arrhythmia is more easily disturbed by external stimuli, which may lead to more chaotic electrical activity. Therefore, the present invention chooses to apply a pulse signal within the effective refractory period of the origin of arrhythmia to minimize the impact of the pulse signal on the patient's existing heart rhythm, thereby improving the safety of pulse ablation surgery. Figure 5As shown, in a cardiac cycle 200, the PQ segment 201 represents the period from the termination of the P wave to the start of the QRS complex, and the ST segment 202 represents the period from the termination of the QRS complex to the start of the T wave. The P wave reflects the depolarization process of the atrium, and the repolarization process of the atrium is generally submerged in the QRS complex. It can be considered that the PQ segment 201 approximately reflects the effective refractory period of the atrial muscle (tissue before the ventricle). The QRS complex reflects the depolarization process of the ventricle, and the T wave reflects the repolarization process of the ventricle. It can be considered that the ST segment 202 approximately reflects the effective refractory period of the ventricular muscle. Therefore, for hypertensive patients with supraventricular arrhythmia, the processor module 130 can set the PQ segment 201 of each cardiac cycle 200 as the pulse signal issuance time. For hypertensive patients with ventricular arrhythmia and hypertensive patients with normal heart rhythm, the processor module 130 can set the ST segment 202 of each cardiac cycle 200 as the pulse signal issuance time.

[0098] Optionally, for patients with supraventricular arrhythmias, the timing of issuing the pulse signal is set to be within the PQ segment of each cardiac cycle 200. When the pulse signal is applied to the site to be ablated within the PQ segment of each cardiac cycle 200, the pulse signal is applied within 30ms to 55ms after the peak of the P wave, and lasts for 50ms to 75ms.

[0099] Optionally, for patients with ventricular arrhythmia or normal heart rhythm, the pulse signal emission timing is set to be within the ST segment of each cardiac cycle 200. When the pulse signal is applied to the ablation site within the ST segment of each cardiac cycle 200, the pulse signal is applied within 50ms to 75ms after the peak of the R wave, and the duration is 80ms to 150ms.

[0100] Of course, in other embodiments, the system user can manually set the time to start applying the pulse signal and the duration of application in each cardiac cycle 200 on the control panel or operation interface according to the patient's heart rhythm type.

[0101] Step S05 : setting pulse signal parameters based on the situation inside the renal artery 310 .

[0102] The situation inside the renal artery 310 includes information such as the tolerance of the sympathetic nerves distributed around the renal artery 310 to the pulsed electric field, the thickness of the renal artery 310 vascular wall, and the distance between the two electrodes 111 applying the pulsed electric field. The pulse signal related parameters include the number of the electrode 111 used to apply the pulsed electric field, the pulse polarity, the pulse voltage, the pulse width, the pulse duty cycle, and the pulse duration. The use of a pulse signal with set parameters can cause irreversible electroporation of the sympathetic nerves between the two selected electrodes 111, while minimizing damage to surrounding healthy tissues such as the renal artery 310 vascular wall. The pulse signal parameters can be pre-set in the processor module 130, or they can be manually adjusted by the system user based on experience. The method for setting the pulse signal parameters has been patented and will not be described in detail here.

[0103] Step S06: After confirming the pulse signal issuance timing and pulse signal parameters, the processor module 130 continuously issues control signals to the pulse electric field generating module 120 while detecting the ECG signal, controlling the pulse electric field generating module 120 to continuously generate pulse signals with preset parameters within a specific time period of each cardiac cycle 200.

[0104] In order to further illustrate the timing of issuing the pulse signal, this embodiment selects the pulse ablation device 100 applying the pulse signal in the ST segment 202 as an example for explanation.

[0105] Figure 7 FIG. 4 is a schematic diagram of applying a pulse signal in the ST segment in this embodiment. Figure 7 As shown, the patient's ECG signal includes a first cardiac cycle 200a and a second cardiac cycle 200b. In each cardiac cycle (200a, 200b), at t after each R wave peak, p ms (hereinafter referred to as "starting delay time"), the pulse signal is applied. Therefore, the timing of applying the pulse signal is controlled by the starting delay time. The duration is t q ms (hereinafter referred to as “duration”), the endpoints of the first ST segment 202a and the second ST segment 202b represent the moments when the pulse signal starts and stops being emitted in each cardiac cycle (200a, 200b).

[0106] In one embodiment, for the first cardiac cycle 200a or the second cardiac cycle 200b, t p and t q The values ​​of are the same, and it is only necessary to determine an average value based on the characteristic parameters of several cardiac cycles before applying the pulse signal. In this way, assuming that the pulse duration preset in step S05 is t ms, then at t / t qAfter a cardiac cycle, the pulse ablation operation of the current ablation site is completed. In this mode, only the peak position of the R wave needs to be detected in each cardiac cycle. This mode is relatively simple to implement, but once a premature beat occurs during ablation or the morphology of the ECG signal changes significantly during a cardiac cycle, the pulse signal may fall outside the effective refractory period of the myocardial cells at the non-arrhythmia origin site, which may cause certain surgical risks.

[0107] In another embodiment, for the first cardiac cycle 200a or the second cardiac cycle 200b, t p and t q The value of is determined according to the detection results of the characteristic parameters of the current cardiac cycle. p The value of is the peak moment of the R wave in the current cardiac cycle, T A When the S wave trough returns to the baseline voltage (203 in the figure), B The time difference between q The value of is the time when the S wave trough returns to the baseline voltage level T B The moment T before the T wave when the voltage value crosses the baseline voltage level C In this way, assuming that the pulse duration preset in step S05 is t ms, when the total time of applying the pulse electric field in multiple consecutive cardiac cycles exceeds t ms, the pulse ablation operation of the current part to be ablated is completed. In this mode, the peak moment of the R wave, the moment when the S wave trough returns to the baseline voltage level, and the moment when the voltage value before the T wave crosses the baseline voltage level need to be detected in each cardiac cycle. This mode can adjust the timing of pulse signal issuance according to the characteristic parameters of the electrocardiogram signal in each cardiac cycle, which is more specific.

[0108] In another embodiment, T A is the peak moment of the R wave, T B T is the time after the S wave trough returns to the baseline voltage level for a certain period of time. C It is the moment when the voltage value before the T wave crosses the baseline voltage level for a certain time / a certain amplitude.

[0109] Better, for t p and t q For example, in each cardiac cycle, an upper threshold value t of the duration of the pulse electric field is set. m ms, then when the duration of the pulse signal in a cardiac cycle is t q >t m When the voltage value of the ECG signal has not yet reached the termination standard (crossing the baseline voltage level before the T wave), the processor module 130 will control the pulse electric field generating module 120 to temporarily stop issuing pulse signals.

[0110] Of course, in other embodiments, the ECG signal in each cardiac cycle fluctuates greatly, and the baseline voltage level can be determined according to existing technical means at this time, and the present invention does not limit this.

[0111] Therefore, the processor module 130 determines the average value of the starting delay time and the duration time according to the electrocardiogram signals in a plurality of cardiac cycles before the pulse signal is applied to the ablation site, so as to uniformly set the time and duration time of applying the pulse signal to the ablation site. Furthermore, the processor module 130 may also determine the starting delay time and the duration time in each cardiac cycle according to the characteristic parameters of the electrocardiogram signals in each cardiac cycle, and specifically adjust the time and duration time of applying the pulse signal to the ablation site. In this way, the system user may select these two modes based on the judgment of the stability of the patient's electrocardiogram signals, so as to further improve the efficiency and safety of the operation.

[0112] Based on the same inventive concept, the present invention also provides a controlled pulse ablation method, the method comprising: generating a control signal according to the heart rhythm type, the control signal comprising a pulse signal release timing, wherein different heart rhythm types correspond to different pulse signal release timings. The pulse signal releases a pulse electric field through the electrode, and the pulse electric field acts on the part to be ablated to implement pulse ablation.

[0113] Furthermore, the pulse signal emission timing is set to be within a specific time period of each cardiac cycle of the electrocardiogram signal.

[0114] Furthermore, the timing of pulse signal emission includes the moment and duration of applying the pulse signal; the moment of applying the pulse signal is controlled by the starting delay duration, the starting delay duration refers to the time for delaying the emission of the pulse signal after the occurrence of the characteristic parameter, and the moment of applying the pulse signal is after the starting delay duration; the duration refers to the duration of the pulse signal in each cardiac cycle.

[0115] Optionally, based on the electrocardiogram signals in a plurality of cardiac cycles, an average value of the start delay time and the duration time is determined to uniformly set the time for applying the pulse signal and the duration time of the site to be ablated.

[0116] Optionally, the start delay time and the duration time in each cardiac cycle are determined based on characteristic parameters of the electrocardiogram signal in each cardiac cycle, so as to respectively set the moment of applying the pulse signal and the duration time of the ablation site.

[0117] Furthermore, the control signal includes pulse signal parameters, and the ECG signal includes P wave, QRS complex and T wave; the characteristic parameters of the ECG signal include the starting time, peak time and / or end time of the P wave, R wave and T wave, wherein the R wave is a wave in the QRS complex, the time period between the end point of the P wave and the starting point of the QRS complex is the PQ segment of the cardiac cycle, the time period between the end point of the QRS complex and the starting point of the T wave is the ST segment of the cardiac cycle, and the specific time period includes the PQ segment and the ST segment.

[0118] Further, the heart rhythm type includes abnormal heart rhythm and normal heart rhythm, and the abnormal heart rhythm includes supraventricular arrhythmia and ventricular arrhythmia. When the heart rhythm type is supraventricular arrhythmia, the pulse signal issuance timing is set to be located within the PQ segment of each cardiac cycle; when the heart rhythm type is ventricular arrhythmia and normal heart rhythm, the pulse signal issuance timing is set to be located within the ST segment of each cardiac cycle.

[0119] Based on the same inventive concept, the present invention also provides a computer-readable storage medium on which a computer program is stored, and when the program is executed by a processor, the controlled pulse ablation method is implemented.

[0120] It should be understood that the memory in the embodiments of the present invention may be a volatile memory or a non-volatile memory, or may include both volatile and non-volatile memories. Among them, the non-volatile memory may be a read-only memory (ROM), a programmable read-only memory (PROM), an erasable programmable read-only memory (EPROM), an electrically erasable programmable read-only memory (EEPROM), or a flash memory. The volatile memory may be a random access memory (RAM), which is used as an external cache. By way of example but 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 synchronous dynamic random access memory (DDRSDRAM), enhanced synchronous dynamic random access memory (ESDRAM), synchronous link DRAM (SLDRAM) and direct RAM bus random access memory (DR RAM).

[0121] The graphical user interface (GUI) displayed on the display 133 is introduced below.

[0122] Figure 8 is a graphical user interface in this embodiment. Figure 8 As shown, the pulse ablation device 100 presents the control interface and the analysis result of the central processor 132 to the system user through the graphical user interface GUI of the display 133. The graphical user interface GUI includes the first to fifth functional areas.

[0123] The first functional area b1 is used for system users to operate. The number of the electrode 111 used to apply the pulsed electric field can be selected through a drop-down list. The electrode 111 numbers include the anode electrode number and the cathode electrode number. For the convenience of description, the anode electrode is marked as 111A and the cathode electrode is marked as 111C. At the same time, the shape of the currently used interventional device 110 is displayed next to it, and the various electrodes 111 assembled thereon and their respective number values ​​are drawn on the interventional device 110. The preferred solution is that after the numbers of the anode electrode 111A and the cathode electrode 111C are set, the set anode electrode 111A and cathode electrode 111C will be marked on the interventional device 110 with colors different from other electrodes 111 to distinguish them. For example, the anode electrode 111A is marked in red, the cathode electrode 111C is marked in blue, and the other electrodes 111 are marked in black.

[0124] The second functional area b2 is used to set pulse signal parameters, including pulse polarity, pulse voltage, pulse width, pulse duty cycle and pulse duration, etc. These parameters can be preset by the system, and system users can also edit and adjust these parameters according to their own experience.

[0125] The third functional area b3 is used to set the timing of the pulse electric field release. It includes the following settings:

[0126] Heart rhythm type: including supraventricular arrhythmia, ventricular arrhythmia and normal heart rhythm; it should be known that, as mentioned above, the heart rhythm type can be obtained by the central processor 132 analyzing the characteristic parameters of the electrocardiogram signal, or can be manually set by the system user;

[0127] Starting waveform: used to set the characteristic parameters of a certain ECG signal to be detected in each cardiac cycle. The characteristic parameters of the ECG signal are used to control the timing of the start of the pulse signal. Figure 7 The moment T A .like Figure 8 If the "heart rhythm type" displayed in is ventricular arrhythmia, then the "starting waveform" can be set to "R wave", that is, to detect the peak moment of the R wave in each cardiac cycle.

[0128] Start delay time: Set the delay time of the pulse signal after the start waveform occurs, corresponding to Figure 7 The parameter t in p : That is, t is set at the peak position of the R wave in each cardiac cycle. p ms later, the pulse signal starts to be applied.

[0129] Duration: Set the duration of the pulse signal in each cardiac cycle, corresponding to Figure 7 The parameter t in q:That is, set the pulse signal to be applied in each cardiac cycle for t q After ms, the pulse signal is stopped until the next cardiac cycle.

[0130] Applied time: used to display the sum of the pulse signal durations in all cardiac cycles in which pulse signals are emitted. It should be noted that this item is read-only and cannot be edited.

[0131] The fourth functional area b4 is used to display the ECG signal transmitted in real time by the ECG signal acquisition module 140. It can be the standard I lead of the body surface, or the standard II lead of the body surface, or the ECG signals of multiple leads can be displayed simultaneously. Generally, the detection result of the processor module 130 will be marked on the ECG signal waveform, such as the detection result of the starting waveform (see the dots in the figure). In addition, the patient's heart rate and other statistical information (not shown) will generally be displayed in the blank area.

[0132] The fifth functional area b5 is the control interaction area of ​​the processor module 130 to the pulse electric field generating module 120, and mainly includes two control buttons.

[0133] The function of the "Start" button is: after the system user confirms that the settings of the electrode 111 in the first functional area b1, the settings of the pulse signal parameters in the second functional area b2 and the settings of the pulse signal emission timing in the third functional area b3 are correct, clicking the "Start" button can control the pulse electric field generating module 120 to continuously emit pulse signals within a specific time period of each cardiac cycle according to the preset mode. At the same time, the "Applied Time" column in the third functional area b3 will continue to count after being reset to zero, displaying the sum of the pulse signal durations in all cardiac cycles.

[0134] The function of the "Stop" button is: once any accident or error occurs during the operation, the pulse electric field generating module 120 can be controlled to stop issuing pulse signals by clicking this button.

[0135] Of course, the start and stop and related parameters of the pulse electric field generating module 120 can also be controlled by directly operating the control panel of the pulse electric field generating module 120. In addition, in addition to stopping the application of the pulse electric field by using the "Stop" button, in other embodiments, it can also be set that when the "applied time" in the third functional area b3 is higher than the "pulse duration" set in the second functional area b2, the application of the pulse electric field is automatically terminated.

[0136] It should be noted that the design 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 electrodes 111, etc.) is also not fixed and can be adjusted according to actual needs. The present invention does not limit this.

[0137] In order to better understand the pulse ablation system of the present invention, Fig. 9 The process of using the pulse ablation system in this embodiment is described below.

[0138] Step S1: The operation starts by passing the distal end of the interventional device 110 through the vascular access to the renal artery 310 .

[0139] Step S2 : Move the distal end of the interventional device 110 back and forth in the renal artery 310 and apply a stimulation signal to determine the site to be ablated in the renal artery 310 .

[0140] Step S3: The ECG signal acquisition module 140 acquires the ECG signal of the patient and sends it to the processor module 130. The processor module 130 detects the characteristic parameters of the ECG signal and obtains the patient's heart rhythm type. Then, the processor module 130 sends a control signal to the pulse electric field generation module 120 according to the patient's heart rhythm type and other external conditions.

[0141] Step S4: After receiving the control signal from the processor module 130, the pulse electric field generating module 120 will continuously start / stop generating pulse signals of specified parameters according to the control signal until the specified total pulse duration is reached.

[0142] Step S5: After applying the pulse electric field according to the specified pulse duration, it is necessary to confirm whether the current part has been ablated. The specific judgment method can be similar to the method used to determine the part to be ablated. If the ablation is not thorough enough, it is necessary to apply the pulse electric field again, and repeat the operation until the current part is ablated successfully.

[0143] Step S6: Next, if there are other sites to be ablated, the above-mentioned surgical procedure only needs to be repeated until all sites to be ablated have been ablated, and the surgery is terminated.

[0144] It should be noted that the above steps are not necessarily executed sequentially, and there may be parallel operations between the steps. For example, the operation of collecting the patient's ECG signal in step S3 may be performed at the beginning of the operation.

[0145] Although the present invention takes the renal artery sympathetic nerve pulse ablation technology as an example, those skilled in the art can understand that the present invention can also be applied to pulse ablation technology in other parts or other fields, and can also be applied to non-ablative pulse treatment technology. As long as it is necessary to determine the timing of pulse electric field emission according to the heart rhythm type, the technical concept of the present invention can be applied, and only structural adaptive adjustments are required. The present invention can be applied not only to the human body, but also to other animal bodies. In the claims, they are all included in the scope of the target object, and the present invention does not limit this.

[0146] The above is only a preferred embodiment of the present invention and does not limit the present invention in any way. Any technician in the relevant technical field, without departing from the scope of the technical solution of the present invention, makes any form of equivalent replacement or modification to the technical solution and technical content disclosed in the present invention, which does not depart from the content of the technical solution of the present invention and still falls within the protection scope of the present invention.

Claims

1. A pulse ablation device, It is characterized in that include: A processor module, used for outputting a control signal according to the heart rhythm type; as well as A pulse electric field generating module, used for outputting a pulse signal according to the control signal, the pulse electric field generating module is used for connecting with an interventional device, the interventional device is provided with electrodes, the pulse signal acts on the part to be ablated through the electrodes to implement pulse ablation; The control signal includes a pulse signal issuing timing, wherein different heart rhythm types correspond to different pulse signal issuing timings, and the pulse signal issuing timing is set to be located within a specific time period of each cardiac cycle of the electrocardiogram signal; The electrocardiogram signal includes a P wave, a QRS complex and a T wave; the characteristic parameters of the electrocardiogram signal include the starting time, peak time and / or ending time of the P wave, the R wave and the T wave, wherein the R wave is a wave in the QRS complex, the time period between the end point of the P wave and the starting point of the QRS complex is the PQ segment of the cardiac cycle, the time period between the end point of the QRS complex and the starting point of the T wave is the ST segment of the cardiac cycle, and the specific time period includes the PQ segment and the ST segment; The heart rhythm types include abnormal heart rhythm and normal heart rhythm, and the abnormal heart rhythm includes supraventricular arrhythmia and ventricular arrhythmia; When the heart rhythm type is supraventricular arrhythmia, the pulse signal issuance timing is set to be located within the PQ segment of each cardiac cycle; and / or When the heart rhythm type is ventricular arrhythmia and normal heart rhythm, the pulse signal issuance timing is set to be within the ST segment of each cardiac cycle.

2. The pulse ablation device according to claim 1, It is characterized in that The pulse ablation device also includes an ECG signal acquisition module for acquiring ECG signals. The processor module receives the ECG signals, obtains the heart rhythm type according to characteristic parameters of the ECG signals, and determines the timing of issuing the pulse signal according to the heart rhythm type.

3. The pulse ablation device according to claim 2, It is characterized in that The processor module is used to continuously update the control signal according to the continuously received electrocardiogram signal and output the updated control signal to the pulse electric field generating module.

4. The pulse ablation device according to claim 1, It is characterized in that The pulse ablation device also includes an input module for inputting the heart rhythm type, and the processor module determines the timing of issuing the pulse signal according to the heart rhythm type.

5. The pulse ablation device according to claim 1, It is characterized in that The control signal includes pulse signal parameters; when the processor module sets the pulse signal emission timing and the pulse signal parameters, the processor module emits the control signal to the pulse electric field generating module, and the control signal controls the pulse electric field generating module to continuously generate a pulse signal with preset parameters within a specific time period of each cardiac cycle.

6. The pulse ablation device according to claim 1, It is characterized in that The pulse signal issuance timing includes the time and duration of applying the pulse signal; The moment of applying the pulse signal is controlled by the starting delay time, which refers to the time for delaying the release of the pulse signal after the characteristic parameter occurs, and the moment of applying the pulse signal is after the starting delay time; the duration refers to the duration of the pulse signal in each cardiac cycle.

7. The pulse ablation device according to claim 6, It is characterized in that The processor module determines the average value of the start delay time and the duration time based on the electrocardiogram signals in a plurality of cardiac cycles before applying the pulse signal to the site to be ablated, so as to uniformly set the time of applying the pulse signal and the duration time.

8. The pulse ablation device according to claim 6, It is characterized in that The processor module determines the start delay time and the duration time in each cardiac cycle according to the characteristic parameters of the electrocardiogram signal in each cardiac cycle, so as to respectively set the time of applying the pulse signal and the duration time.

9. The pulse ablation device according to claim 6, It is characterized in that The timing of applying the pulse signal in the PQ segment of each cardiac cycle is within 30ms to 55ms after the peak of the P wave, and the duration is 50ms to 75ms; and / or, The time of applying the pulse signal in the ST segment of each cardiac cycle is within 50ms~75ms after the peak value of the R wave, and the duration is 80ms~150ms.

10. The pulse ablation device according to claim 1, It is characterized in that The pulse ablation device further comprises a stimulation module for generating a stimulation signal, wherein the stimulation signal acts on the target object through the intervention device to determine the site to be ablated.

11. The pulse ablation device according to claim 1, It is characterized in that The processor module also includes a display and a central processing unit, the display is used to display the control interface and the analysis results of the central processing unit; the control signal includes pulse signal parameters, and the pulse electric field generating module also includes a control panel, and the pulse signal parameters can be remotely controlled through the control interface and / or controlled through the control panel.

12. A pulse ablation system, It is characterized in that include: The pulse ablation device according to any one of claims 1 to 11; An interventional device is used to be connected to the pulse ablation equipment. An electrode is provided at the distal end of the interventional device. The pulse signal acts on the part to be ablated through the electrode to implement pulse ablation.

13. A controlled pulse ablation method, It is characterized in that The method comprises: generating a control signal according to the heart rhythm type, the control signal comprising a pulse signal issuing timing, wherein different heart rhythm types correspond to different pulse signal issuing timings, and the pulse signal issuing timing is set to be located within a specific time period of each cardiac cycle of the electrocardiogram signal; The electrocardiogram signal includes a P wave, a QRS complex and a T wave; the characteristic parameters of the electrocardiogram signal include the starting time, peak time and / or ending time of the P wave, the R wave and the T wave, wherein the R wave is a wave in the QRS complex, the time period between the end point of the P wave and the starting point of the QRS complex is the PQ segment of the cardiac cycle, the time period between the end point of the QRS complex and the starting point of the T wave is the ST segment of the cardiac cycle, and the specific time period includes the PQ segment and the ST segment; The heart rhythm types include abnormal heart rhythm and normal heart rhythm, and the abnormal heart rhythm includes supraventricular arrhythmia and ventricular arrhythmia; When the heart rhythm type is supraventricular arrhythmia, the pulse signal emission timing is set to be located within the PQ segment of each cardiac cycle; and / or When the heart rhythm type is ventricular arrhythmia and normal heart rhythm, the pulse signal issuance timing is set to be within the ST segment of each cardiac cycle.

14. The controlled pulse ablation method according to claim 13, It is characterized in that The timing of pulse signal emission includes the moment and duration of applying the pulse signal; the moment of applying the pulse signal is controlled by the starting delay duration, the starting delay duration refers to the time of delaying the emission of the pulse signal after the characteristic parameters of the electrocardiogram signal occur, and the moment of applying the pulse signal is after the starting delay duration; the duration refers to the duration of the pulse signal in each cardiac cycle.

15. The controlled pulse ablation method according to claim 14, It is characterized in that Determine the average value of the start delay time and the duration time according to the electrocardiogram signals in the plurality of cardiac cycles, so as to uniformly set the time of applying the pulse signal and the duration time of the part to be ablated; or, The start delay time and the duration time in each cardiac cycle are determined according to characteristic parameters of the electrocardiogram signal in each cardiac cycle, so as to respectively set the time for applying the pulse signal and the duration time in the part to be ablated.

16. A computer-readable storage medium having a computer program stored thereon, It is characterized in that When the program is executed by a processor, the controlled pulse ablation method as described in any one of claims 13 to 15 is implemented.

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