CN112618010B

CN112618010B - Ablation system

Info

Publication number: CN112618010B
Application number: CN202110257562.4A
Authority: CN
Inventors: 朱美娇; 周磊; 史胜凤; 薛卫
Original assignee: Shanghai Antaike Medical Technology Co ltd
Current assignee: Shanghai Antaike Medical Technology Co ltd
Priority date: 2021-03-10
Filing date: 2021-03-10
Publication date: 2021-05-28
Anticipated expiration: 2041-03-10
Also published as: CN112618010A

Abstract

The invention provides an ablation system, which comprises pulse control equipment and pulse ablation catheter equipment, wherein the polarity of the positive electrode and the negative electrode of any two adjacent pulse sequences received by at least one pair of electrodes in the pulse ablation catheter equipment is controlled to be opposite through a combined switch module in the pulse control equipment, so that the electrode damage is reduced, the problems that the pulse release effect is reduced and the electrode sticking capacity is influenced by the electrode damage are solved, the pulse release effect is more stable, the electrode is completely stuck to a preset object, the ablation efficiency is improved, and the operation time is shortened; furthermore, the ablation system also has the function of recognizing arrhythmia, and when arrhythmia is recognized, the pulse is stopped to be released, so that the pulse ablation process is safer and more reliable.

Description

Ablation system

Technical Field

The invention relates to the field of medical instruments, in particular to an ablation system.

Background

Atrial fibrillation is the most common arrhythmia, with an incidence of about 1% and increasing with age. Studies have shown that catheter ablation is an effective means for patients with atrial fibrillation to restore and maintain their heart rhythm. Currently, the commonly used ablation energy is mainly radio frequency energy and is assisted by cryo-energy, and the two ablation methods have advantages and limitations, for example, the ablation energy (cold or heat) has no selectivity for damaging the tissue in the ablation area, depends on the adhesion force of the catheter, and may damage the adjacent esophagus, coronary artery or phrenic nerve, thereby affecting the treatment effect. The pulse ablation is a novel ablation mode taking a high-voltage electric field as energy, is an athermal ablation technology, has tissue selectivity, and carries out ablation energy by adopting a plurality of high-voltage pulses released in a short time through designing a proper pulse electric field. The method can effectively induce the myocardial cells to generate irreversible electroporation, so that extracellular ions enter the cells, and when high-concentration calcium ions enter, the myocardial cells are cracked and die. The damage to the tissue with higher threshold of the pulse electric field is also reversible, so that the myocardial conduction system can be directionally damaged, and complications caused by damage to other surrounding tissues are avoided.

However, in the pulse ablation operation, after a plurality of pulse sequence discharges, the electrode has the problem of yellowing and blackening, which represents that the electrode is damaged. Electrode damage affects the effect of pulse release on the one hand and the electrode ability to be attached, causing incomplete and discontinuous attachment of the electrode to the intended subject, affecting the effectiveness of the procedure.

In addition, the prior art pulse ablation generally controls all electrodes to release pulses at the same time, namely, the electrodes of the same pulse ablation catheter device are ablated synchronously, but the ablation range cannot be controlled accurately when facing a complex ablation object.

Disclosure of Invention

In order to solve the above technical problems, an object of the present invention is to provide an ablation system, which at least solves the problem of electrode damage after multiple pulse train discharges in the prior art.

Another objective of the present invention is to provide an ablation system, which has a function of recognizing arrhythmia, and stops releasing pulses when arrhythmia is recognized, so as to improve the safety and reliability of the pulse ablation process.

In order to achieve the above object, the present invention provides an ablation system comprising a pulse control device and a pulse ablation catheter device;

the pulse ablation catheter apparatus includes a catheter and an electrode holder disposed at a distal end of the catheter and including at least one pair of electrodes;

the pulse control equipment comprises a main control module, a combined switch module and a high-voltage pulse module; the main control module is respectively in communication connection with the combined switch module and the high-voltage pulse module;

the main control module is used for controlling the high-voltage pulse module to output high-voltage pulses to the combined switch module;

the main control module is also used for controlling the on-off of a circuit between the high-voltage pulse module and the at least one pair of electrodes through the combined switch module, and controlling the polarity of the positive electrode and the negative electrode of any two adjacent pulse sequences received by the at least one pair of electrodes to be opposite through the combined switch module.

Optionally, the pair of electrodes includes a first electrode and a second electrode, and the combination switch module includes a pulse polarity selection switch;

when a current pulse sequence is issued, the main control module is used for controlling the pulse polarity selection switch to connect the positive electrode of the high-voltage pulse module with the first electrode and controlling the pulse polarity selection switch to connect the negative electrode of the high-voltage pulse module with the second electrode;

when a next pulse sequence adjacent to the current pulse sequence is issued, the main control module is used for controlling the pulse polarity selection switch to connect the anode of the high-voltage pulse module with the second electrode, and is used for controlling the pulse polarity selection switch to connect the cathode of the high-voltage pulse module with the first electrode.

Optionally, the combination switch module further includes electrode selection switches, the number of the electrode selection switches is the same as the number of the electrodes, and each electrode is connected to the high-voltage pulse module through a corresponding one of the electrode selection switches.

Optionally, the pulse control device further includes a refractory period detection module, and the main control module is in communication connection with the refractory period detection module; the refractory period detection module is used for identifying arrhythmia, when the refractory period detection module identifies arrhythmia, the refractory period detection module sends a signal for stopping outputting high-voltage pulse to the main control module, and the main control module controls the high-voltage pulse module to stop sending high-voltage pulse when receiving the signal for stopping outputting high-voltage pulse.

Optionally, the electrode holder comprises a plurality of pairs of electrodes; and the main control module is used for controlling at least one pair of the electrodes in the plurality of pairs of electrodes to release ablation energy through the combined switch module every time pulse ablation is carried out.

Optionally, the electrode holder includes an electrode proximal end, an electrode main body, and an electrode distal end, which are sequentially connected along the extension direction of the catheter;

the electrode main body is of a net structure, and at least one of the proximal end and the distal end of the electrode is movably connected with the catheter;

the electrode body is configured to transition between a collapsed state and an expanded state as the electrode proximal end and/or the electrode distal end moves along the catheter;

the electrode body expands radially outward of the catheter when the electrode body is in the expanded state.

Optionally, the pulse ablation catheter apparatus further comprises a balloon disposed at the distal end of the catheter; when the balloon is expanded, the electrode body is supported to keep the expanded state, so that the electrode body is attached to a preset object.

Optionally, the pulse control device further includes a cooling cycle control module in communication connection with the main control module; the cooling circulation control module is used for filling and recovering a cooling medium into the saccule under the control of the main control module.

Optionally, the pulse control device further includes an output signal detection module in communication connection with the main control module;

the output signal detection module is used for detecting an analog signal in the high-voltage pulse signal and converting the analog signal into an output voltage digital signal and/or an output current digital signal.

Optionally, the pulse control device further includes a refractory period detection module, and the main control module is in communication connection with the refractory period detection module; the refractory period detection module is used for extracting R waves from the electrocardiosignals, and the R waves are delayed for a certain time and then send signals for starting high-voltage pulse delivery to the main control module; the main control module is used for receiving the signal for starting the delivery of the high-voltage pulse, and controlling the high-voltage pulse module to output the high-voltage pulse to the combination switch module within the heart refractory period.

Optionally, the pulse control device further comprises a temperature detection module in communication connection with the main control module, and the temperature detection module is used for measuring the temperature of the electrode in real time and transmitting the temperature to the main control module.

Optionally, the electrode body comprises a plurality of first sub-electrodes extending in a longitudinal direction of the catheter, the plurality of first sub-electrodes being distributed circumferentially around the catheter; the electrode main body further comprises a plurality of second sub-electrodes, the second sub-electrodes extend along the transverse direction of the catheter, and two ends of each second sub-electrode are respectively connected with two adjacent first sub-electrodes;

the second sub-electrodes are mutually parallel; the second sub-electrode is V-shaped; the electrode body is configured to decrease in size from the electrode middle end toward the electrode proximal end and the electrode distal end when the electrode body is in the expanded state; the second sub-electrode comprises a first folded edge and a second folded edge, and at least one of the first folded edge and the second folded edge comprises at least two stages; the electrode body has the same radial dimension from the electrode proximal end to the electrode distal end when the electrode body is in the collapsed state; the electrode body comprises a first section and a second section from the electrode far end to the electrode near end, and the longitudinal arrangement density of the electrodes of at least one part of the second section is not less than that of the first section; the second section comprises a high-density subsection and a low-density subsection, the high-density subsection is close to the first section, the low-density subsection is far away from the first section, and the longitudinal arrangement density of the electrodes of the high-density subsection is not less than that of the electrodes of the low-density subsection and the first section respectively.

Optionally, the expanded state includes a first expanded sub-state and a second expanded sub-state, the maximum radial dimension of the electrode body is an electrode middle end, and a projection of the electrode middle end on the catheter is located between the electrode proximal end and the electrode distal end when the electrode body is in the first expanded sub-state; when the electrode body is in the second dilator state, one of the electrode proximal end and the electrode distal end, a projection of the tip on the catheter in the electrode, and the other of the electrode proximal end and the electrode distal end.

Optionally, the balloon is proximal to the electrode proximal end, the balloon being configured to limit displacement of the electrode proximal end toward the proximal end of the catheter when expanded.

In order to achieve the above object, the present invention also provides an ablation system comprising a pulse control device and a pulse ablation catheter device;

the pulse control equipment comprises a main control module, a high-voltage pulse module and a refractory period detection module; the main control module is respectively in communication connection with the high-voltage pulse module and the refractory period detection module;

the main control module is used for controlling the high-voltage pulse module to output high-voltage pulses;

the main control module is in communication connection with the refractory period detection module; the refractory period detection module is used for identifying arrhythmia, and when the refractory period detection module identifies arrhythmia, the refractory period detection module sends a signal for stopping outputting high-voltage pulses to the main control module, and the main control module controls the high-voltage pulse module to stop issuing high-voltage pulses when receiving the signal for stopping outputting high-voltage pulses.

The ablation system provided by the invention has the following advantages:

firstly, when a plurality of pulse sequences are discharged, the sequence of the positive electrode and the negative electrode is alternately selected, so that the electrode damage is reduced, the problems that the electrode damage reduces the pulse release effect and influences the electrode sticking capability are avoided, the pulse release effect is more stable, the electrode is completely stuck to a preset object, the ablation efficiency is improved, and the operation time is reduced;

the combined switch module comprises an electrode selection switch, the electrode selection switch controls the on-off of the high-voltage pulse module and an inter-electrode circuit, and when a plurality of pairs of electrodes exist, the electrodes can be respectively controlled to be switched on and off through the corresponding electrode selection switches, namely, the electrodes at different positions on the pulse ablation catheter equipment are gated, so that the accuracy of an ablation range can be improved;

when the refractory period detection module identifies arrhythmia, the refractory period detection module sends a signal for stopping outputting high-voltage pulse to the main control module, and the main control module controls the high-voltage pulse module to stop pulse transmission to stop ablation, so that the pulse ablation process is safer and more reliable;

fourthly, the electrode support of the pulse ablation catheter device comprises a mesh-shaped electrode main body, and the mesh-shaped structure can provide continuous contact, has larger electrode surface area and lower thermal effect; and the balloon is filled with a cooling medium, so that the cooling function of the electrode can be provided, the heat effect generated by the electrode is eliminated, and the electrode can be supported, so that the electrode can be better attached to tissues.

Drawings

FIG. 1 is a block diagram of an ablation system according to a preferred embodiment of the present invention;

FIG. 2 is a schematic view of the preferred embodiment of the electrode body of the present invention in an expanded state;

FIG. 3 is a schematic illustration of the electrode body of the preferred embodiment of the present invention in a contracted state;

FIG. 4 is a schematic view of the second sub-electrode with the electrode body in a contracted state according to the preferred embodiment of the present invention;

FIG. 5 is a schematic view of an electrode body of another preferred embodiment of the present invention;

FIGS. 6 and 7 are schematic views of a pulse ablation catheter apparatus in accordance with a preferred embodiment of the present invention;

FIG. 8 is a schematic view of a pulsatile ablation catheter apparatus in accordance with another preferred embodiment of the present invention;

FIG. 9 is an enlarged view of portion A of the electrode body of FIG. 5;

FIG. 10 is a cross-sectional view of the pulse ablation catheter apparatus of FIG. 8 taken along the direction B-B;

FIG. 11 is a schematic diagram of a single bipolar pulse signal in a preferred embodiment of the present invention;

FIG. 12 is a schematic diagram of a composite bipolar pulse signal in a preferred embodiment of the present invention;

fig. 13 is a schematic diagram of the switch connections of the combination switch module of the preferred embodiment of the present invention.

The reference numerals are explained below:

101-a pulse control device; 102-a master control module; 103-refractory period detection module; 104-temperature detection module; 105-a cooling cycle control module; 106-high voltage pulse module; 107-a combination switch module; 108-a human-computer interaction module; 109-output signal detection module; 310-a pulsed ablation catheter device;

131-a pulse polarity selection switch; 132-electrode selection switch;

100-electrodes; 110-electrode proximal end; 120-an electrode body; 121-electrode middle; 130-electrode distal end; 140-a first sub-electrode; 150-a second sub-electrode; 151-first folded edge; 152-a second folded edge; 1510-stage; 160-a first section; 170-a second section; 171-high density subsection; 172-low density subsection;

200-a catheter; 201-electrode holder; 210-an outer body; 220-a support shaft; 231-punch-in channels; 232-a recovery channel; 240-a guide wire channel; 250-a first wire channel; 260-a second wire channel;

300-a tuning electrode; 400-balloon; 500-a handle; 600-a wire; an X-catheter electrode section.

Detailed Description

The embodiments of the present invention are described below with reference to specific embodiments, and other advantages and effects of the present invention will be easily understood by those skilled in the art from the disclosure of the present specification. The invention is capable of other and different embodiments and of being practiced or of being carried out in various ways, and its several details are capable of modification in various respects, all without departing from the spirit and scope of the present invention. It should be noted that the drawings provided in the present embodiment are only for illustrating the basic idea of the present invention, and the drawings only show the components related to the present invention rather than the number, shape and size of the components in actual implementation, and the type, quantity and proportion of the components in actual implementation may be changed arbitrarily, and the layout of the components may be more complicated.

Furthermore, each of the embodiments described below has one or more technical features, which does not mean that all of the technical features of any one embodiment must be implemented simultaneously by the inventor or that only some or all of the technical features of different embodiments can be implemented separately. In other words, those skilled in the art can selectively implement some or all of the features of any embodiment or combinations of some or all of the features of multiple embodiments according to the disclosure of the present invention and according to design specifications or implementation requirements, thereby increasing the flexibility in implementing the invention. In addition, as used in this specification, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise.

The invention discloses an ablation system, which at least solves the problem that an electrode is damaged after multiple pulse sequence discharges in the prior art.

Fig. 1 is a block diagram of an ablation system according to a preferred embodiment of the present invention.

As shown in fig. 1, the present embodiment provides an ablation system comprising a pulse control device 101 and a pulse ablation catheter device 310. The pulse control device 101 comprises a main control module 102, a high-voltage pulse module 106 and a combination switch module 107; preferably, the pulse control apparatus 101 further comprises a refractory period detection module 103 and/or a cooling cycle control module 105.

The main control module 102 is in communication connection with the high-voltage pulse module 106 and the combination switch module 107, and further, the main control module 102 is also in communication connection with the refractory period detection module 103 and the cooling cycle control module 105.

The main control module 102 is used for controlling the high voltage pulse module 106 to output the high voltage pulse to the combination switch module 107. Further, the main control module 102 is further configured to control the refractory period detection module 103 to detect the electrocardiographic signal, after the refractory period detection module 103 obtains the electrocardiographic signal, the refractory period detection module 103 is further configured to extract an R wave from the electrocardiographic signal, and after the R wave is delayed for a certain time, the refractory period detection module 103 sends a signal for starting the delivery of the high-voltage pulse to the main control module 102. Further, the main control module 102 is also used for controlling the high voltage pulse module 106 to output the high voltage pulse to the combination switch module 107 in the heart refractory period according to the received signal for starting the delivery of the high voltage pulse.

Fig. 2 provides a pulse ablation catheter apparatus 310 in accordance with a preferred embodiment of the present invention. As shown in fig. 2, the pulse ablation catheter apparatus 310 includes a catheter 200 and an electrode holder 201, the electrode holder 201 is disposed at the distal end of the catheter 200, the electrode holder 201 includes at least one pair of electrodes 100, and the at least one pair of electrodes 100 is configured to receive a high voltage pulse emitted from the high voltage pulse module 106 to deliver ablation energy to a target tissue. It should be understood that each pair of electrodes 100 includes a positive electrode and a negative electrode, the positive electrode is used for electrically conducting with the positive electrode of the high voltage pulse module 106, and the positive electrode receives the first pulse wave of the pulse sequence as a positive voltage; the negative electrode is used for being electrically conducted with the negative electrode of the high-voltage pulse module 106, and the negative electrode receives the first pulse wave of the pulse sequence and is a negative voltage; and positive and negative electrodes are present in pairs to form current paths. In addition, the combination switch module 107 controls the on-off of the circuit between the at least one pair of electrodes 100 and the high-voltage pulse module 106 under the control of the main control module 102, and when the combination switch module 107 controls the conduction of the circuit between the electrodes 100 and the high-voltage pulse module 106, the high-voltage pulse emitted by the high-voltage pulse module 106 is allowed to be output to the at least one pair of electrodes 100, so that the at least one pair of electrodes 100 emits ablation energy after receiving the high-voltage pulse.

Further, the electrode holder 201 also includes an electrode loading device on which at least one pair of electrodes 100 is disposed, the electrode loading device being disposed at the distal end of the catheter 200. In some embodiments, the electrode loading apparatus includes a balloon with at least one pair of electrodes 100 disposed on a surface of the balloon, and the balloon can be inflated against the target tissue. In other embodiments, the electrode loading device is a mesh-like electrode holder 201, and the electrode holder 201 itself is comprised of the electrodes 100, i.e., the electrode holder 201 itself has electrical properties capable of delivering ablative energy to the target tissue.

In the following description, the ablation system of the present invention is further illustrated by the mesh electrode holder 201, but the mesh electrode holder should not be construed as limiting the present invention.

Further, the pulse ablation catheter apparatus 310 preferably further comprises a balloon 400 (see fig. 2, 6) disposed at the distal end of the catheter 200. When the balloon 400 is expanded, the electrode stent 201 is supported to maintain the expanded state so that the electrode stent 201 is applied to a predetermined object. By arranging the balloon 400, when the electrode stent 201 is in an expanded state, the balloon 400 is expanded by itself or the balloon 400 is expanded and then moves towards the distal end of the electrode stent 201 so as to apply a compressive stress towards the distal end of the electrode stent 201 to the electrode stent 201, so that the electrode stent 201 is attached to a predetermined object more stably, continuously and completely, and further the ablation efficiency is improved.

Further, the main control module 102 is also used to control the cooling circulation control module 105 to fill and retrieve a cooling medium (such as cold saline, nitrous oxide, or contrast agent) into the balloon 400. The balloon 400 is inflated with a cooling medium and then expanded, and the balloon 400 is contracted after the cooling medium is recovered. Here, the temperature of the electrode 100 can be controlled by providing the cooling cycle control module 105, preventing the electrode 100 from overheating.

In addition, the main control module 102 is preferably used to provide power to the high voltage pulse module 106, the refractory period detection module 103, and the cooling cycle control module 105. Further, the main control module 102 is an embedded industrial personal computer. Preferably, the main control module 102 includes a power supply module (not shown) for converting an externally input ac power into a dc power, and the main control module 102 provides the dc power to the high voltage pulse module 106 to convert the dc power into a high voltage pulse signal.

Further, the high voltage pulse module 106 includes a high voltage energy storage module (not shown) and a high voltage pulse generation circuit (not shown). The high-voltage pulse generating circuit is used for converting the direct current provided by the main control module 102 into a high-voltage pulse signal through processing such as inversion, isolation boosting, rectification filtering and the like, and inputting the high-voltage pulse signal into the high-voltage energy storage module for storage. Preferably, the high-voltage pulse generating circuit adopts a single chip microcomputer as a main chip, generates control pulses through programming, converts the control pulses into pulse signals through a level conversion chip, and further generates bipolar high-voltage pulse signals through a control circuit (such as an H-bridge circuit), wherein the bipolar high-voltage pulse signals comprise single bipolar pulse signals and composite bipolar pulse signals, and the process is to convert the high-voltage direct current signals into the high-voltage pulse signals. Preferably, the high-voltage energy storage module adopts a high-voltage energy storage capacitor. The high voltage storage capacitor is connected in parallel to the input of the high voltage pulse generation circuit and delivers the high voltage pulse signal to the combination switch module 107. The single bipolar pulse signal is shown in fig. 11, with time T on the abscissa and voltage U (unit V) on the ordinate. The composite bipolar pulse signal is shown in fig. 12, with time T on the abscissa and voltage U (unit V) on the ordinate.

Referring back to fig. 1, the pulse control apparatus 101 preferably further comprises an output signal detection module 109 communicatively coupled to the main control module 102 and the high voltage pulse module 106, respectively. The output signal detection module 109 is configured to detect a high-voltage pulse signal sent by the high-voltage pulse module 106 and send a detection result to the main control module 102, and the main control module 102 obtains pulse parameters issued by the high-voltage pulse module 106 according to the detection result of the output signal detection module 109, where the pulse parameters include information such as applied pulse voltage, pulse shape, single pulse width, pulse period and/or number of pulses in the pulse period, so that a doctor can control an ablation process according to the pulse parameters.

The output signal detection module 109 further includes a voltage detection circuit (not shown) for detecting a voltage signal in the high-voltage pulse signal emitted by the high-voltage pulse module 106, and a current detection circuit (not shown) for detecting a current signal in the high-voltage pulse signal emitted by the high-voltage pulse module 106. Preferably, the voltage detection circuit uses a voltage probe, and the current detection circuit uses a current sensor. The voltage probe is used for acquiring and converting the voltage of the high-voltage pulse signal output by the high-voltage pulse module 106, and converting the high-voltage signal into a low-voltage signal, wherein the corresponding voltage in the high-voltage signal is higher than the voltage in the low-voltage signal. The current sensor is configured to collect and convert a current of the high-voltage pulse signal output by the high-voltage pulse module 106, and convert a large-current signal into a low-current signal, where a corresponding current in the large-current signal is higher than a current in the low-current signal. The output signal detection module 109 further includes an analog-to-digital conversion circuit (not shown) for converting the low voltage signal and the low current signal into an output voltage digital signal and an output current digital signal and transmitting the output voltage digital signal and the output current digital signal to the main control module 102.

In addition, the main control module 102 also controls the on/off of the circuit between the high voltage pulse module 106 and at least one pair of electrodes 100 through the combination switch module 107. The main control module 102 has a switch control program, and controls the polarity of the positive electrode and the negative electrode of any two adjacent pulse sequences received by any pair of electrodes 100 in the combined switch module 107 to be opposite through the switch control program. Here, the first pulse wave of the pulse sequence output by the positive electrode of the high-voltage pulse module 106 is one electrode of a positive voltage, the positive electrode of the high-voltage pulse module 106 is connected to the positive electrode, the first pulse wave of the pulse sequence output by the negative electrode of the high-voltage pulse module 106 is one electrode of a negative voltage, and the negative electrode of the high-voltage pulse module 106 is connected to the negative electrode. In this embodiment, each pair of electrodes 100 includes a first electrode and a second electrode. Specifically, when a current pulse sequence is issued, the main control module 102 controls the positive electrode of the high-voltage pulse module 106 to be electrically conducted with a first electrode of the same pair of electrodes 100 through the combination switch module 107, and controls the negative electrode of the high-voltage pulse module 106 to be electrically conducted with a second electrode of the same pair of electrodes 100 through the combination switch module 107, where the first electrode is a positive electrode and the second electrode is a negative electrode; when the next pulse adjacent to the current pulse sequence is issued, the main control module 102 controls the positive electrode of the high-voltage pulse module 106 to be electrically conducted with the second electrode through the combination switch module 107, and controls the negative electrode of the high-voltage pulse module 106 to be electrically conducted with the first electrode through the combination switch module 107, at this time, the second electrode is a positive electrode, and the first electrode is a negative electrode; by analogy, the polarities of the two electrodes in the same electrode pair are changed alternately in the same mode, so that a pulse sequence is released for multiple times, the sequence of the positive electrode and the negative electrode is selected alternately when the pulse sequence is released for multiple times, the damage to the electrodes is reduced, the problems that the damage to the electrodes reduces the pulse release effect and influences the electrode sticking capacity are avoided, the pulse release effect is stable, the electrodes are completely stuck to a preset object, the ablation efficiency is improved, and the operation time is shortened.

Further, the combination switch module 107 receives a switch gating signal output by the main control module 102, and the switch gating signal needs to be preset in the main control module 102 in advance, so that the combination switch module 107 controls the polarities of the two electrodes of the same pair of electrodes 100 according to the switch gating signal and realizes electrical conduction, and a high-voltage pulse signal is output to the pulse ablation catheter device 310 through the positive current channel and the negative current channel to realize pulse ablation.

Further, in conjunction with fig. 1 and 13, the combination switch module 107 includes a pulse polarity selection switch 131. The main control module 102 is used to control the automatic pulse polarity switching selection switch 131 to be connected with the positive and negative electrodes of the corresponding pair of electrodes 100 each time when the high-voltage pulse sequence is released for multiple times through a switch control program. By connecting the pulse polarity-changing selection switch 131 with the positive and negative electrodes of the pair of electrodes 100, the problem that the electrodes 100 are yellow and black to cause electrode damage in a pulse ablation operation due to multiple pulse release pulse sequences can be greatly reduced, and the pulse release effect and the adhesion of the electrodes 100 to a preset object can be more stable. Further, as shown in fig. 13, a plurality of electrodes 100 may be connected in parallel, and in this case, only two pulse polarity selection switches 131 of positive pulse/negative pulse may be provided; it should be understood that similar circuit design changes are simple circuit transformations, and such changes are within the scope of the present invention.

In this embodiment, the combination switch module 107 further includes electrode selection switches 132, the number of the electrode selection switches 132 is the same as the number of the electrodes 100, each electrode 100 is connected to the high-voltage pulse module 106 through a corresponding one of the electrode selection switches, and a maximum of 36 pulse ablation catheter devices 310 can be accessed by one ablation system.

As shown in fig. 13, the high-voltage pulse module 106 outputs positive pulses and negative pulses, and the combined switch module 107 selectively switches in the positive pulses or the negative pulses by each pulse polarity selection switch 131 under the control of the switch control program, as indicated by the configuration of six electrodes (i.e., electrode one to electrode six) on one pulse ablation catheter device 310; each electrode selection switch 132 is independently controlled to be turned on or off, so that the on-off of each electrode 100 can be more accurately controlled, and for a complex ablation object, parts of electrodes 100 (such as a first electrode and a second electrode) on the same pulse ablation catheter device 310 can be controlled to perform ablation, so that the pulse ablation object is more accurate. That is, when the current pulse sequence is delivered, the main control module 102 can control at least one of the pairs of electrodes to release the pulse through the electrode selection switch 132, and can also control all the electrodes to deliver the pulse at the same time.

Preferably, the pulse polarity selection switch 131 and the electrode selection switch 132 may be vacuum relays, MOS transistors, or semiconductor devices such as silicon carbide.

Further, the refractory period detection module 103 generally includes an electrocardiograph (not shown) for acquiring electrocardiograph signals of the body surface and an electrocardiograph signal processing device (not shown). It is understood that the cardiac electrical signal is the conduction of bioelectric current generated by the heart at activation from the heart to various parts of the body; because the distance between each part of the body and the heart is different due to different tissues of each part of the body, the electrocardiosignals show different potential changes at different parts of the body surface. The variable electric potential between each part on the body surface is taken out through the electrocardio-electrode and the lead wire. The electrocardiograph signal processing device includes an electrocardiograph signal amplifier circuit (not shown), a filter circuit (not shown), and an R wave detection circuit (not shown), and is configured to find out an R wave from the electrocardiograph signal and transmit the R wave to the main control module 102. It should be understood that the R-wave delay of 50ms to 200ms is the effective refractory period of the heart, and the master control module 102 sends a signal to the high voltage pulse module 106 to start the high voltage pulse in the effective refractory period of the heart.

Preferably, the refractory period detection module 103 further has an electrocardiographic signal recognition program for recognizing arrhythmia, when the refractory period detection module 103 recognizes arrhythmia, the refractory period detection module 103 sends a signal to the main control module 102 to stop outputting high-voltage pulses, and the main control module 102 controls the high-voltage pulse module 106 to stop sending high-voltage pulses when receiving the signal to stop outputting high-voltage pulses, thereby stopping pulse ablation. Under the prior art, tens of types of arrhythmia can be identified by comparing the electrocardiosignals with the database, pulse ablation is stopped in time, and the pulse ablation process is safer and more reliable.

Preferably, the pulse control device 101 further comprises a temperature detection module 104 in communication connection with the main control module 102, and the temperature detection module 104 is disposed on the electrode holder 201 and is used for monitoring the thermal effect of the electrode 100. Further, the temperature detecting module 104 includes a temperature sensor (not shown) for measuring the temperature around the electrode 100 in real time and generating temperature information, and a temperature analog-to-digital converting circuit (not shown) for converting the temperature information into a digital signal and transmitting the digital signal to the main control module 102, and the main control module 102 further transmits the digital signal corresponding to the temperature to the display for displaying. Further, during the ablation process, the temperature of the ablation cannot exceed a preset range, and if the temperature exceeds the preset range, the system gives an alarm. Furthermore, the temperature alarm threshold is 50-60 ℃. In this embodiment, the temperature detection module 104 is configured to measure the temperature near each electrode, and send the temperature data near each electrode to the main control module 102 in real time, preferably, the main control module 102 may determine whether the detected temperature exceeds a temperature alarm threshold through a program, and when the temperature exceeds the temperature alarm threshold, prompt an operator to suspend ablation.

Preferably, the impulse control device 101 further comprises a human-machine interaction module 108 for inputting and displaying ablation-related data. Human-machine interaction module 108 includes a display (not shown) and an input device (not shown). The display is used for receiving and displaying various information transmitted by the main control module 102, such as output voltage digital signals, output current digital signals, R-wave, temperature and other information. For example, when the main control module 102 determines that the detected temperature exceeds the temperature alarm threshold, the display may prompt the operator to suspend ablation, and it should be understood that the prompting mode of the display may be a highlighted temperature value or a blinking temperature value. The human-computer interaction module 108 sets pulse parameters (including pulse voltage, pulse width, pulse period and the number in the pulse sequence) through an input device. Furthermore, the applied pulse voltage can cause the myocardial tissue to generate irreversible electroporation, so as to realize the effect of pulse ablation, and the range of the pulse voltage is usually 500V-2500V, the range of the single pulse width is 1us-200ms, the range of the pulse period is 2us-200ms, and the number in the pulse sequence is 1-1000. Preferably, the human-computer interaction module 108 may employ a computer touch screen, so that a display and an input device can be integrated. The invention is not limited to the specific device of the human-computer interaction module 108, and a display, a mouse and a keyboard can be designed as the human-computer interaction module 108.

Further, the cooling cycle control module 105 includes an infusion pump device (not shown) for filling and recovering the cooling medium to the balloon 400. The cooling cycle control module 105 is operated after the ablation catheter 310 reaches the vicinity of the target tissue, and can determine whether the ablation catheter 310 has reached the vicinity of the target tissue by the imaging device. When the balloon 400 is filled with the cooling medium, the filled cooling medium reaches a certain amount (the surface of the balloon 400 is completely opened without folds), and the balloon 400 is expanded; after the pulse ablation is completed, the cooling medium in the balloon 400 is pumped out and recovered by the perfusion pump device.

With further reference to fig. 2 in conjunction with fig. 3, the present embodiment also provides an electrode holder 201, wherein the electrode holder 201 is used for transmitting energy between the device and the human tissue. An electrode holder 201 is intended to be arranged at the distal end of the catheter 200. The electrode holder 201 comprises an electrode proximal end 110, an electrode main body 120 and an electrode distal end 130 which are sequentially connected along the axial direction of the catheter 200, wherein the electrode main body 120 is of a net structure (preferably, a spherical net structure), at least one of the electrode proximal end 110 and the electrode distal end 130 is movably connected with the catheter 200, and the electrode main body 120 is configured to be switched between a contraction state and an expansion state along with the movement of the electrode proximal end 110 and/or the electrode distal end 130 along the catheter 200; referring to fig. 3, when the electrode body 120 is in the contracted state, the electrode body 120 is folded and abuts against the catheter 200 inward along the radial direction of the catheter 200; with continued reference to fig. 2, when the electrode body 120 is in the expanded state, the electrode body 120 expands radially outward of the catheter 200. Further, the expanded state includes a first expanded sub-state (specifically shown in fig. 2 as the first expanded sub-state) and a second expanded sub-state, and the maximum radial dimension of the electrode body 120 is the electrode middle end 121. With continued reference to fig. 2, when the electrode body 120 is in the first dilating sub-state, the projection of the electrode middle end 121 on the catheter 200 is located between the electrode proximal end 110 and the electrode distal end 130; referring to fig. 7 (it should be noted that, the balloon 400 is not included here), when the electrode main body 120 is in the second dilating sub-state, one of the electrode proximal end 110 and the electrode distal end 130 is between the projection of the electrode middle end 121 on the catheter 200 and the other of the electrode proximal end 110 and the electrode distal end 130, specifically, it can be understood that, in the axial direction of the catheter 200, the electrode proximal end 110 is between the electrode middle end 121 and the electrode distal end 130, or the electrode distal end 130 is between the electrode proximal end 110 and the electrode middle end 121. It is to be understood that the maximum radial dimension herein refers to the maximum distance from the outer edge of the electrode body 120 to the catheter 200 when the electrode body 120 is in the first sub-state of expansion, the second sub-state of expansion, or a transition between the two sub-states of expansion; the projection here refers to the projection of the electrode middle end 121 along the radial direction of the catheter 200. By placing the electrode body 120 in an expanded state with displacement of the electrode proximal end 110 and/or the electrode distal end 130, the electrode body 120 can be deformed to abut a predetermined object, thereby performing an electrode ablation procedure.

Further, with continued reference to fig. 2 and 3, the catheter 200 includes an outer tube 210 and a stent shaft 220, and it should be noted that reference numerals of the stent shaft 220 in fig. 2 are labeled at a distal end of the stent shaft 220, and reference numerals of the stent shaft 220 in fig. 3 are labeled on a shaft body of the stent shaft 220. The support shaft 220 is movably disposed through the outer tube 210, and the support shaft 220 extends out of the outer tube 210 toward the distal end. The proximal electrode end 110 and the distal electrode end 130 are movably connected to the catheter 200, and in one embodiment, the proximal electrode end 110 and the distal electrode end 130 are movably disposed on the outer tube 210 or the stent shaft 220, and the state of the electrode body 120 is changed by changing the relative distance between the proximal electrode end 110 and the distal electrode end 130 after the proximal electrode end 110 and the distal electrode end 130 are moved. In another specific embodiment, one of the proximal electrode end 110 and the distal electrode end 130 is fixed to one end of the catheter 200, and the other is movably disposed on the catheter 200 relative to the catheter 200, such as one of the proximal electrode end 110 and the distal electrode end 130 is fixed to the stent shaft 220 and the other is movably disposed on the stent shaft 220, or one of the proximal electrode end 110 and the distal electrode end 130 is fixed to the outer tubular body 210 and the other is movably disposed on the outer tubular body 210. In addition, the positions of the outer tube body 210 and the stent shaft 220 can be locked so that the outer tube body 210 and the stent shaft 220 do not slide relative to each other, the electrode proximal end 110 can be movably arranged on the outer tube body 210, and/or the electrode distal end 130 can be movably arranged on the stent shaft 220, so that the state change of the electrode main body 120 can also be realized. In an exemplary embodiment, the electrode proximal end 110 and/or the electrode distal end 130 may be coupled to a pull wire, respectively, to guide the relative movement therebetween.

In the above description, the support shaft 220 is movably disposed through the outer tube body 210, and the present invention describes another embodiment that one of the electrode proximal end 110 and the electrode distal end 130 is movably connected to the catheter 200, that is, the electrode proximal end 110 is fixedly disposed on the outer tube body 210, and the electrode distal end 130 is fixedly disposed on the support shaft 220, so that the relative distance between the electrode proximal end 110 and the electrode distal end 130 can be changed by the movement of the support shaft 220 through the outer tube body 210 (for this reason, the catheter 200 can be understood to have flexibility). The electrode 100 will be described below by taking an umbrella as an example, and it should be understood that the example "umbrella" is only used for the auxiliary description of the electrode and is not limited thereto. The electrode and catheter assembly 200 is configured as an umbrella, the electrode body 120 is configured as an umbrella frame, the stent shaft 220 and the outer body 210 is configured as a telescoping umbrella shaft, and the electrode body 120 is configured to move from a collapsed state to a first expanded sub-state to a second expanded sub-state, such as from the collapsed state to a semi-expanded state to a fully expanded state. In other embodiments, the initial state of the electrode main body 120 is the second expansion sub-state, and the electrode main body 120 is inserted into the target site of the cavity after being converted into the contracted state, and then the electrode main body 120 is restored to the initial state (i.e. the second expansion sub-state) to ablate the target site due to the tension of the electrode main body 120 toward the distal end, specifically, as explained in the example of the umbrella, after the umbrella is opened, the umbrella is in the fully-expanded state due to the tension of the umbrella frame (equivalent to the electrode main body 120 being in the second expansion sub-state), and is gradually converted from the semi-expanded state (equivalent to the electrode main body 120 being in the first expansion sub-state) into the contracted state by means of external force, and after the external force is removed, the umbrella frame is automatically converted into the fully. In addition, the umbrella can be converted from a contraction state to a half-expansion state under the action of external force and then to a full-expansion state, so that the electrode main body 120 in the contraction state is inserted into a target position of the cavity, and then is converted into a first expansion sub-state and then is converted into a second expansion sub-state by virtue of the external force, and then ablation treatment is carried out. It will be appreciated that in this case, the electrode body 120 is in the contracted state, i.e. the electrode body 120 is in contact with the stent shaft 220 in the radial direction of the stent shaft 220, the electrode body 120 is in the first expanded sub-state, i.e. the projection of the electrode middle end 121 on the stent shaft 220 is between the electrode proximal end 110 and the electrode distal end 130, and the electrode body 120 is in the second expanded sub-state, i.e. the projection of the electrode proximal end 110 on the electrode middle end 121 on the stent shaft 220 is between the electrode distal end 130 and the electrode proximal end 121. It should be noted that, by switching the electrode main body 120 between the first expansion sub-state and the second expansion sub-state, the electrode main body 120 can be attached to a predetermined object to perform ablation, and it should be noted that, preferably, ablation is performed by using the electrode main body 120 in the second expansion sub-state, so that the ablation area can be increased, and the ablation efficiency can be improved.

Preferably, the electrode body 120 is made of a compliant or semi-compliant material, such as nitinol, so that the electrode body 120 in the expanded state provides an increased effective contact area with the target site, and the electrode body 120 in the contracted state provides an effective contact area with the catheter 200 (specifically, the stent shaft 220). More preferably, a metal coating, such as gold or tantalum, may be coated on the surface of the electrode body 120 to improve the stability and thermal conductivity of the electrode body 120.

Further, the electrode body 120 comprises a plurality of first sub-electrodes 140, the first sub-electrodes 140 extending in a longitudinal direction of the catheter 200, the plurality of first sub-electrodes 140 being circumferentially distributed around the catheter 200. Here, the longitudinal direction refers to a direction substantially along the axial direction of the catheter 200, and may also be understood as a direction substantially along the axial direction of the stent shaft 220, specifically, both ends of the first sub-electrode 140 are respectively connected with the stent shaft 220, i.e. the first sub-electrode 140 may be regarded as extending along the longitudinal direction of the stent shaft 220; the plurality of first sub-electrodes 140 may be uniformly or non-uniformly distributed circumferentially around the stent shaft 220, and those skilled in the art may configure the first sub-electrodes accordingly according to actual situations.

In an exemplary embodiment, referring to fig. 5, a plurality of first sub-electrodes 140 are cross-connected to each other in a transverse direction of the catheter 200 (stent shaft 220). The lateral direction here means substantially along the circumferential direction of the holder shaft 220. In the present embodiment, the electrode main body 120 is only formed by the plurality of first sub-electrodes 140 being woven to be crossed with each other in a mesh shape.

In another exemplary embodiment, with continued reference to fig. 2, the electrode main body 120 includes a plurality of second sub-electrodes 150, the second sub-electrodes 150 extend along the transverse direction of the catheter 200 (the stent shaft 220), and two ends of each second sub-electrode 150 are respectively connected to two adjacent first sub-electrodes 140. Unlike the electrode main body 120 formed of only the plurality of first sub-electrodes 140 as described above, the plurality of first sub-electrodes 140 of the electrode main body 120 in this embodiment do not intersect with each other in the electrode main body 120 except for being connectable to each other at the proximal and distal ends, and have a gap in the lateral direction of the stent shaft 220, and the second sub-electrodes 150 are disposed in the gap to connect the adjacent two first sub-electrodes 140. Further, the plurality of second sub-electrodes 150 are parallel to each other.

In a preferred embodiment, the second sub-electrode 150 has a V-shape. When the second, expanded sub-state of the electrode body 120 is with the electrode proximal end 110 located between the projection of the electrode middle end 121 on the catheter 200 and the electrode distal end 130, the open end of the V-shape is directed towards the electrode distal end 130; when the second, expanded sub-state of the electrode body 120 is such that the electrode distal end 130 is located between the projection of the electrode middle end 121 on the stent shaft 220 and the electrode proximal end 110, the open end of the V-shape is directed towards the electrode proximal end 110. By providing the second sub-electrode 150 in a V-shape, the electrode main body 120 is facilitated to be contracted and folded.

Preferably, the electrode body 120 is gradually reduced in size from the electrode middle end 121 towards the electrode proximal end 110 and the electrode distal end 130 when the electrode body 120 is in the expanded state (the first expansion sub-state or the second expansion sub-state). So configured, the electrode body 120 is tightly attached to the catheter 200 (specifically, the stent shaft 220) after the electrode body 120 is contracted and folded into a contracted state. It should be understood that the dimensions of the electrode body 120 herein refer to the degree of openness of the open end of the V-shape.

Further, the second sub-electrode 150 includes a first folded edge 151 and a second folded edge 152, the first folded edge 151 is connected to a proximal end of the second folded edge 152 to form a V-shaped corner, and distal ends of the first folded edge 151 and the second folded edge 152 are respectively connected to two adjacent first sub-electrodes 140; or the distal ends of the first folded edge 151 and the second folded edge 152 are connected to form a V-shaped corner, and the proximal ends of the first folded edge 151 and the second folded edge 152 are respectively connected to two adjacent first sub-electrodes 140. Both of these conditions depend on the particular morphology of the second dilator state. Preferably, the first folded edge 151 and the second folded edge 152 are connected by a torsion joint, so that the anti-kink performance of the second sub-electrode 150 can be increased, and the first folded edge 151 and the second folded edge 152 can be prevented from being broken when the electrode body 120 is in the first expanded sub-state or the second expanded sub-state.

It should be noted that the above-mentioned V-shape cannot be understood in a narrow sense as a V-shape formed by straight line segments of the first folded edge 151 and the second folded edge 152, and is understood as a substantially V-shape, for example, at least one of the first folded edge 151 and the second folded edge 152 has a curved line segment (the curvature of the curved line segment is small, for example, ± 5 °); or at least one of the first folded edge 151 and the second folded edge 152 is a broken line segment (shaped like a wavy line or a zigzag line), the broken line segment comprises a plurality of sub-line segments which are sequentially connected, and the length of the sub-line segment and the connecting angle of the two adjacent sub-line segments are negligible in the actual required range; or the first folded edge 151 and the second folded edge 152 may be a combination of any two of a curved line segment, a straight line segment, and a broken line segment.

In a preferred embodiment, as shown in fig. 4, at least one of the first folded edge 151 and the second folded edge 152 includes at least two stage 1510 (the first folded edge 151 and the second folded edge 152 shown in fig. 4 each include two stage 1510). This case corresponds to the case where the first folded edge 151 and the second folded edge 152 are both folded line segments, and preferably, two sub-line segments adjacent to each other of the folded line segments are respectively connected vertically, wherein a sub-line segment extending along the longitudinal direction of the catheter 200 (the horizontal direction in fig. 4) has a larger length, that is, a sub-line segment extending along the horizontal direction of the catheter 200 (the vertical direction in fig. 4) of the step section 1510 has a smaller length, and serves to connect two adjacent stage. Furthermore, when both folding edges have a step, the lifting directions of the steps of the two folding edges are opposite, such as one clockwise and the other counterclockwise.

Preferably, in two adjacent second sub-electrodes 150 located between the electrode distal end 130 and the electrode middle end 121, the length of the stage close to the electrode middle end 121 in the second sub-electrode close to the electrode distal end 130 is greater than the length of the stage close to the electrode distal end 130 in the second sub-electrode close to the electrode middle end 121. So configured, when the electrode main body 120 is in the contracted state, all the second sub-electrodes 150 between two adjacent first sub-electrodes 140 have the same length along the circumferential direction of the stent shaft 220, so that the electrode main body 120 is folded.

Alternatively, when the electrode body 120 is in the contracted state, the electrode body 120 has the same size from the electrode proximal end 110 to the electrode distal end 130, i.e., the radial size (specifically understood as the diameter) of each portion of the electrode body 120 is the same.

Optionally, the electrode body 120 includes a first section 160 and a second section 170 from the electrode distal end 130 to the electrode proximal end 110, and the first section 160 and the second section 170 of the electrode body 120 form an ellipsoidal shape when in the first expander state; when the electrode body 120 is in the second expander state, the first section 160 and the second section 170 form an umbrella shape; thus, the electrode main body 120 is switched between the first and second expansion sub-states, and can be brought into close contact with ablation target portions of different shapes. Alternatively, the first segment 160 may be divided into a plurality of sub-segments along the longitudinal direction by an insulating material to generate different polarities in the electrode body 120.

In addition, the longitudinal arrangement density of the electrodes of at least a portion of the second section 170 is not less than the longitudinal arrangement density of the electrodes of the first section 160. When the electrode main body 120 is used for ablation, a part of the second section 170 is mainly attached to a target position, and by increasing the longitudinal arrangement density of at least one part of the electrodes of the second section 170, the energy for ablation can be increased, and the ablation efficiency is improved. The electrode longitudinal arrangement density here refers to the arrangement number of the first sub-electrodes 140 and/or the second sub-electrodes 150 along the longitudinal direction of the catheter 200 (or the direction from the electrode proximal end 110 to the electrode distal end 130). Specifically, for the electrode main body 120 formed by only interleaving the first sub-electrodes 140 in fig. 5, the coverage area of the first sub-electrodes 140 in the second section 170 can be increased by increasing the number of times the first sub-electrodes 140 are interleaved in the second section, so as to increase the longitudinal arrangement density of the electrodes; for the electrode body 120 formed by connecting the first sub-electrode 140 and the second sub-electrode 150 in fig. 2, the longitudinal arrangement density of the electrodes can be increased by increasing the number of the second sub-electrodes 150 arranged in the longitudinal direction of the second section 170.

Further, the second section 170 includes a high density sub-section 171 and a low density sub-section 172, the high density sub-section 171 is close to the first section 160, the low density sub-section 172 is far from the first section 160, and the longitudinal arrangement density of the electrodes of the high density sub-section 171 is not less than that of the low density sub-section 172 and the first section 160, respectively. So configured, the high density sub-section 171 is used for the main ablation site, which can reduce the energy loss of the first section 160 and the low density sub-section 172 while improving the ablation efficiency.

As shown in fig. 6, the present embodiment further provides another pulse ablation catheter apparatus 310, which includes a balloon 400, a catheter 200 and the electrode holder 201 as described above, wherein the balloon 400 and the electrode 100 are disposed at the distal end of the catheter 200, and when the balloon 400 is expanded, the balloon is used to support the electrode main body 120 to maintain the expanded state, so that the electrode main body 120 is attached to the predetermined object.

In a preferred embodiment, referring to fig. 6 and 7, a balloon 400 is positioned adjacent to the electrode proximal end 110, and the balloon 400 is configured to limit the displacement of the electrode proximal end 110 toward the proximal end of the catheter 200 when the balloon 400 is expanded. Specifically, after the balloon 400 is expanded, the balloon is displaced towards the distal end to apply a compressive stress towards the electrode distal end 130 to the electrode main body 120, so that the electrode main body 120 maintains the second expander state, and the electrode main body 120 is more stably, continuously and completely attached to the predetermined object, thereby improving the ablation efficiency. In fact, after the electrode main body 120 is in the second dilating sub-state, it abuts against some predetermined object (such as the pulmonary vein ostium), the shape of the pulmonary vein ostium (which is substantially conical) does not completely fit with the shape of the electrode main body 120 in the second dilating sub-state (such as umbrella shape), so that a part of the pulmonary vein ostium cannot be ablated, and the goal of continuous ablation can be achieved by arranging the balloon 400 to abut against the electrode main body 120, and increasing the effective abutting area of the electrode main body 120 and the pulmonary vein ostium by utilizing the compliance or semi-compliance of the electrode main body 120 and the compressive stress applied by the balloon 400.

In other embodiments, referring to fig. 2 or 5, the balloon 400 may be disposed inside the electrode body 120, and the balloon 400 may be configured to limit deformation of the balloon 400 when the balloon 400 is expanded. Specifically, the balloon 400 expands by itself and abuts against the electrode main body 120, and further expands to bring the electrode main body 120 from the contracted state to the expanded state (specifically, the first expanded sub-state), and further adheres to the predetermined object.

Preferably, the balloon 400 is compliant or semi-compliant so that the balloon 400, when inflated, conforms to the structure of the site to be ablated to better conform the electrode body 120 to the site to be ablated. Additionally, balloon 400 is preferably made of a polymeric material, such as nylon, or a modified nylon (e.g., conductive nylon).

Further, referring to fig. 8, the ablation catheter apparatus 310 further includes a handle 500, the catheter 200 and the electrode holder 201 are sequentially connected from the proximal end to the distal end, specifically, the handle 500 is connected to the outer tube 210 for driving the outer tube 210 to move along the holder shaft 220 to control the configuration change of the electrode body 120. Optionally, referring to fig. 6, for the pulse ablation catheter apparatus 310, an adjusting electrode 300 with a polarity opposite to that of the electrode main body 120 may be disposed at the distal end of the stent shaft 220, and of course, for the electrode stent 201, a corresponding adjusting electrode 300 may also be disposed at the distal end of the stent shaft 220. With reference to the adjusting electrode 300 described above and with continued reference to fig. 8, the ablation component of the pulse ablation catheter apparatus 310 may be named as a catheter electrode segment X, specifically including the balloon 400, the electrode stent 201 and the adjusting electrode 300, and it can be understood that the electrode stent 201 is located at the distal end of the balloon 400 or wraps the balloon 400.

Other components of the pulse ablation catheter apparatus 310 may be suitably configured by those skilled in the art in light of the prior art and will not be described further herein. Referring to fig. 10, the stent shaft 220 includes a guide wire channel 240 extending therethrough in an axial direction for placing a pull wire connected to the electrode proximal end 110 for guiding the electrode body 120 of the pulse ablation catheter device 310 to a predetermined position (target site), preferably, the stent shaft 220 is made of stainless steel or reinforced plastic tube, and the guide wire channel 240 is made of Polytetrafluoroethylene (PTFE) or high density ethylene (HDPE) material, and may be further coated with a hydrophilic or hydrophobic ultra-slip coating.

Optionally, referring to fig. 10, the catheter 200 includes a fluid channel for supplying a cooling medium (such as nitrous oxide) to the balloon 400, so as to cool the electrode body 120 during ablation, reduce the thermal effect generated during the ablation stage, and improve the prognosis effect of the treatment. Specifically, the holder shaft 220 has a wash-in passage 231 and a recovery passage 232 that penetrate in the axial direction, the two passages communicate with each other at the distal end of the holder shaft 220, and the cooling medium flows in from the wash-in passage 231 and flows out from the recovery passage 232.

Further, with continuing reference to fig. 10 in conjunction with fig. 9, the stent shaft 220 further has at least one of a first lead channel 250 for placing a lead connected to the proximal end 110 of the electrode and a second lead channel 260 for placing a lead 600 connected to the distal end 130 of the electrode (the lead shown in fig. 9 is disposed in the second lead channel 260), and the energy supply end platform is connected to the electrode via the lead 600 for supplying energy for ablation to the electrode body 120. Fig. 9 is an enlarged view of the portion a in fig. 5 when the balloon 400 is disposed inside the electrode main body 120, or may be an enlarged view of the distal end of the stent shaft 220 when the balloon 400 is disposed at the electrode proximal end 110 and the electrode main body 120 is in the second dilating sub-state in fig. 7.

Optionally, the ablation system further includes a pressure sensor (not shown) disposed on the electrode body 120 for detecting the degree of abutment of the electrode body 120 with the target site.

It should be noted that some circuits related to the present invention, such as a high voltage pulse generating circuit, a voltage detecting circuit, a current detecting circuit, an analog-to-digital converting circuit, an electrocardiograph signal amplifier circuit, a filter circuit, and an R-wave detecting circuit, belong to common circuits known to those skilled in the art, and the present invention does not limit these common circuits in particular, and will not be described in detail.

Claims

1. An ablation system comprising a pulse control device and a pulse ablation catheter device;

the main control module is also used for controlling the on-off of a circuit between the high-voltage pulse module and at least one pair of electrodes through the combined switch module, and controlling the polarity of the positive electrode and the negative electrode of any two adjacent pulse sequences received by the at least one pair of electrodes to be opposite through the combined switch module;

the pair of electrodes comprises a first electrode and a second electrode, and the combination switch module comprises a pulse polarity selection switch;

2. The ablation system of claim 1, wherein the combination switch module further comprises a number of electrode selection switches corresponding to a number of electrodes, each electrode connected to the high voltage pulse module through a corresponding one of the electrode selection switches.

3. The ablation system of claim 1 or 2, wherein the pulse control device further comprises a refractory period detection module, the main control module being communicatively coupled to the refractory period detection module; the refractory period detection module is used for identifying arrhythmia, when the refractory period detection module identifies arrhythmia, the refractory period detection module sends a signal for stopping outputting high-voltage pulse to the main control module, and the main control module controls the high-voltage pulse module to stop sending high-voltage pulse when receiving the signal for stopping outputting high-voltage pulse.

4. The ablation system of claim 1 or 2, wherein the electrode support comprises a plurality of pairs of electrodes; and the main control module is used for controlling at least one pair of the electrodes in the plurality of pairs of electrodes to release ablation energy through the combined switch module every time pulse ablation is carried out.

5. The ablation system of claim 1, wherein the electrode holder includes an electrode proximal end, an electrode main body, and an electrode distal end connected in series along an extension direction of the catheter;

6. The ablation system of claim 5, wherein the pulse ablation catheter apparatus further comprises a balloon disposed at a distal end of the catheter; when the balloon is expanded, the electrode body is supported to keep the expanded state, so that the electrode body is attached to a preset object.

7. The ablation system of claim 6, wherein the pulse control device further comprises a cooling cycle control module communicatively coupled to the main control module; the cooling circulation control module is used for filling and recovering a cooling medium into the saccule under the control of the main control module.

8. The ablation system of claim 1 or 2, wherein the pulse control device further comprises an output signal detection module communicatively coupled to the main control module;

9. The ablation system of claim 1 or 2, wherein the pulse control device further comprises a refractory period detection module, the main control module being communicatively coupled to the refractory period detection module; the refractory period detection module is used for extracting R waves from the electrocardiosignals, and the R waves are delayed for a certain time and then send signals for starting high-voltage pulse delivery to the main control module; the main control module is used for receiving the signal for starting the delivery of the high-voltage pulse, and controlling the high-voltage pulse module to output the high-voltage pulse to the combination switch module within the heart refractory period.

10. The ablation system of claim 1 or 2, wherein the pulse control device further comprises a temperature detection module in communication with the main control module, the temperature detection module being configured to measure the temperature of the electrode in real time and transmit the measured temperature to the main control module.

11. The ablation system of any of claims 5-7, wherein the electrode body includes a plurality of first sub-electrodes extending longitudinally of the catheter, the plurality of first sub-electrodes being distributed circumferentially around the catheter; the electrode main body further comprises a plurality of second sub-electrodes, the second sub-electrodes extend along the transverse direction of the catheter, and two ends of each second sub-electrode are respectively connected with two adjacent first sub-electrodes;

the second sub-electrodes are mutually parallel; the second sub-electrode is V-shaped; the electrode body is configured to decrease in size from the electrode middle end toward the electrode proximal end and the electrode distal end when the electrode body is in the expanded state; the second sub-electrode comprises a first folded edge and a second folded edge, and at least one of the first folded edge and the second folded edge comprises at least two stages; the electrode body has the same radial dimension from the electrode proximal end to the electrode distal end when the electrode body is in the collapsed state; the electrode body comprises a first section and a second section from the electrode far end to the electrode near end, and the longitudinal arrangement density of the electrodes of at least one part of the second section is not less than that of the first section; the second section comprises a high-density subsection and a low-density subsection, the high-density subsection is close to the first section, the low-density subsection is far away from the first section, and the longitudinal arrangement density of the electrodes of the high-density subsection is respectively larger than that of the electrodes of the low-density subsection and the first section.

12. The ablation system of any of claims 5-7, wherein the expanded state includes a first expanded sub-state and a second expanded sub-state, the maximum radial dimension of the electrode body being an electrode middle, a projection of the electrode middle on the catheter being between the electrode proximal end and the electrode distal end when the electrode body is in the first expanded sub-state; when the electrode body is in the second dilator state, one of the electrode proximal end and the electrode distal end, a projection of the tip on the catheter in the electrode, and the other of the electrode proximal end and the electrode distal end.

13. The ablation system of claim 6, wherein the balloon is proximate the electrode proximal end, the balloon when expanded serving to limit displacement of the electrode proximal end toward the proximal end of the catheter.