Pulse ablation system

Abstract

The present application relates to the technical field of medical devices, and particularly relates to a pulse ablation system, which comprises an energy supply module, a high-voltage pulse generation module, an impedance detection module, a pulse ablation catheter and a control module; the energy supply module is configured to supply energy to the high-voltage pulse generation module; the high-voltage pulse generation module is configured to send a high-voltage pulse signal to the pulse ablation catheter; the pulse ablation catheter comprises a plurality of ablation electrodes, the ablation electrodes comprise outer electrodes and inner electrodes, and at least part of the ablation electrodes are configured as working electrodes for receiving the high-voltage pulse signal and performing ablation treatment on target tissue; the impedance detection module is configured to select paired ablation electrodes and detect an impedance value between the paired ablation electrodes, at least one of the paired ablation electrodes being a working electrode; and the control module is configured to receive the impedance value and evaluate the abutting degree of the working electrode and the target tissue. The present application does not need to additionally increase electrodes and sensors, and has high detection speed and precision.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a pulse ablation system. Background Technology

[0002] The application of irreversible electroporation pulsed electric field ablation technology in the treatment of atrial fibrillation is currently a global research hotspot. Pulsed electric field ablation has unparalleled technical advantages over traditional thermal effects; its cell selectivity effectively avoids esophageal and phrenic nerve damage during pulmonary vein isolation ablation. To achieve effective ablation depth, the distribution area of ​​the pulsed electric field intensity formed by the catheter must be maximized, and effective contact between the ablation electrode and the tissue must be ensured.

[0003] Existing technologies include low-voltage pulse detection and sensor-based detection of contact status. The former requires emitting a certain amount of ablation power and cannot achieve real-time detection, while the latter requires additional sensor components and feedback signals from these additional components. Another approach utilizes high-frequency signal detection circuits to detect contact status. These circuits output a weak high-frequency signal to the tissue, rectify and filter it to detect the amplitude of the high-frequency signal, and then detect the impedance. However, this method has limited testing accuracy and cannot meet the requirements for rapid, multi-channel measurements. Summary of the Invention

[0004] The purpose of this invention is to provide a pulse ablation system to at least solve one of the technical problems existing in the prior art or related art.

[0005] To achieve the above objectives, in a first aspect, the present invention provides a pulse ablation system, comprising a power supply module, a high-voltage pulse generation module, an impedance detection module, a pulse ablation catheter, and a control module; wherein,

[0006] The power supply module is electrically connected to the high-voltage pulse generating module and is configured to supply power to the high-voltage pulse generating module.

[0007] The high-voltage pulse generating module is electrically connected to the pulse ablation catheter and the impedance detection module, and is configured to send a high-voltage pulse signal to the pulse ablation catheter.

[0008] The pulse ablation catheter includes a catheter shaft and an electrode segment disposed at the distal end of the catheter shaft. The electrode segment includes an electrode assembly, which includes at least one electrode carrier and a plurality of ablation electrodes located on the electrode carrier. The ablation electrodes include an outer electrode and an inner electrode. In the initial state, the working surface of the outer electrode faces away from the catheter shaft, and the working surface of the inner electrode faces the catheter shaft. At least a portion of the ablation electrodes are configured as working electrodes to receive the high-voltage pulse signal and perform ablation treatment on the target tissue.

[0009] The impedance detection module is electrically connected to the pulse ablation catheter and the control module, and is configured to select paired ablation electrodes and detect the impedance value between the paired ablation electrodes under the control of the control module, wherein at least one of the paired ablation electrodes is the working electrode.

[0010] The control module is configured to receive the impedance value detected by the impedance detection module and evaluate the degree of contact between the working electrode and the target tissue.

[0011] Optionally, at least one of the paired ablation electrodes is the outer electrode.

[0012] Optionally, the outer electrode is disposed near the distal end of the electrode carrier, and the inner electrode is disposed near the proximal end of the electrode carrier, wherein the paired ablation electrodes are the inner electrode and / or the outer electrode.

[0013] Optionally, the electrode segment further includes an end electrode disposed at the distal end of the catheter shaft, wherein one of the paired ablation electrodes is the end electrode and the other is the lateral electrode.

[0014] Optionally, the outer electrodes located on the same electrode carrier are divided into an outer electrode group, and the end electrodes are paired with the outer electrode group in turn to detect the impedance value between the end electrodes and the outer electrodes.

[0015] Optionally, the proximal and distal ends of the electrode carrier are respectively connected to the catheter shaft and can move relative to each other on the catheter shaft, so that the electrode segment switches between a contracted state and an expanded state. In the expanded state, with the distal end of the catheter shaft as the center, the ablation electrodes located within the same outer diameter range are divided into an electrode group, and the paired ablation electrodes in each electrode group are paired in turn at fixed intervals.

[0016] Optionally, the expansion state includes a basket state or a petal state. In the basket state, the paired ablation electrodes are outer electrodes; in the petal state, the paired ablation electrodes are an inner electrode disposed near the proximal end of the electrode carrier and an outer electrode disposed near the distal end of the electrode carrier.

[0017] Optionally, the proximal and distal ends of the electrode carrier are respectively connected to the catheter shaft and can move relative to each other on the catheter shaft, so that the electrode segment switches between a contracted state and an expanded state, the expanded state including a petal state; in the petal state, with the distal end of the catheter shaft as the center, the outer electrodes located within the same outer diameter range are divided into outer electrode groups, and the inner electrodes located within the same outer diameter range are divided into inner electrode groups, the paired ablation electrodes in each outer electrode group are paired alternately at a fixed interval, and the paired ablation electrodes in each inner electrode group are paired alternately at a fixed interval; and / or,

[0018] In the petal state, the outer electrodes located on the same electrode carrier are divided into an outer electrode group, and the inner electrodes located on the same electrode carrier are divided into an inner electrode group. The paired ablation electrodes in each outer electrode group are paired in turn at a fixed interval, and the paired ablation electrodes in each inner electrode group are paired in turn at a fixed interval.

[0019] Optionally, the impedance detection module detects the initial impedance value when the ablation electrode comes into contact with blood, and the paired ablation electrode used to detect the initial impedance value is an inner electrode located near the proximal end of the electrode carrier.

[0020] Optionally, the initial impedance value is detected before the working electrode is brought into contact with the target tissue.

[0021] Optionally, the impedance detection module further includes a first multiplexer switch, which includes a plurality of first selector switches that correspond one-to-one with and are electrically connected to the ablation electrodes. The first selector switches are configured to selectively open or close under the control of the control module, so that the impedance detection module is electrically connected to the corresponding paired ablation electrodes.

[0022] Optionally, the pulse ablation system further includes a mapping module, which is electrically connected to the pulse ablation catheter and the control module. The mapping module is configured to select at least a portion of the ablation electrodes as mapping electrodes under the control of the control module to detect the electrocardiogram signal of the target tissue.

[0023] Secondly, the present invention also provides another pulse ablation system, including a power supply module, a high-voltage pulse generation module, a mapping module, a pulse ablation catheter, a control module, and an interlocking module; wherein,

[0024] The power supply module is electrically connected to the high-voltage pulse generating module and is configured to supply power to the high-voltage pulse generating module.

[0025] The high-voltage pulse generating module is electrically connected to the pulse ablation catheter and the mapping module, and is configured to send a high-voltage pulse signal to the pulse ablation catheter.

[0026] The pulse ablation catheter includes a plurality of ablation electrodes, at least some of which are configured as working electrodes to receive the high-voltage pulse signal and perform ablation treatment on the target tissue.

[0027] The mapping module is electrically connected to the pulse ablation catheter and the control module, and is configured to select at least a portion of the ablation electrodes as mapping electrodes under the control of the control module to detect the electrocardiogram signal of the target tissue.

[0028] The interlock module is electrically connected to the control module and the high-voltage pulse generation module. During mapping, the mapping module sends a cut-off signal to the control module. The control module controls the interlock module to cut off the high-voltage pulse signal output of the high-voltage pulse generation module, and receives the electrocardiogram signal detected by the mapping module to evaluate the treatment effect.

[0029] Thirdly, the present invention also provides another pulse ablation system, including a power supply module, a high-voltage pulse generation module, a data acquisition module, a diagnostic module, a pulse ablation catheter, and a control module; wherein,

[0030] The power supply module is electrically connected to the high-voltage pulse generation module and is configured to supply power to the high-voltage pulse generation module.

[0031] The high-voltage pulse generating module is electrically connected to the pulse ablation catheter and is configured to send a high-voltage pulse signal to the pulse ablation catheter.

[0032] The pulse ablation catheter includes a plurality of ablation electrodes, at least some of which are configured as working electrodes to receive the high-voltage pulse signal and perform ablation treatment on the target tissue.

[0033] The control module is configured to control the high-voltage pulse generation module to perform pre-discharge according to the discharge mode. During pre-discharge, the working voltage provided by the power supply module is less than the working voltage provided by the power supply module during ablation treatment.

[0034] The acquisition module is electrically connected to the pulse ablation catheter and is configured to acquire the current and voltage data of the working electrode during pre-discharge.

[0035] The diagnostic module is electrically connected to the acquisition module and the control module, and is configured to determine whether the discharge of the working electrode is normal based on the acquired current and voltage data, and to feed back to the control module.

[0036] Optionally, the pulse ablation system further includes a human-machine interface electrically connected to the control module. The control module is also configured to establish a three-dimensional model of the pulse ablation catheter based on impedance values ​​according to the electrode morphology in the treatment mode, and display it through the human-machine interface.

[0037] Optionally, the pulse ablation system further includes an electrode switching module, which is electrically connected to the high-voltage pulse generation module, the pulse ablation catheter, and the control module. The electrode switching module is configured to receive the high-voltage pulse signal sent by the high-voltage pulse generation module under the control of the control module, and to select the working electrode and switch between positive and negative poles.

[0038] Optionally, the electrode switching module includes a first-layer combination switch, a second-layer combination switch, and a third-layer combination switch; wherein,

[0039] The input terminals of the first layer combination switch are electrically connected to the positive and negative terminals of the high-voltage pulse signal output, respectively;

[0040] The input terminals of the second-layer combination switch can be switched to correspond to the output terminals of the first-layer combination switch, and the second-layer combination switch is configured to perform the reversal of the positive and negative poles under the control of the control module;

[0041] The third-layer combination switch includes multiple ablation selection switches that correspond one-to-one with the ablation electrodes. The input terminal of the ablation selection switch is electrically connected to the second-layer combination switch, and the output terminal of the ablation selection switch is electrically connected to the corresponding ablation electrode. The third-layer combination switch is configured to select the working electrode and determine the positive and negative values ​​of each working electrode under the control of the control module.

[0042] Optionally, the mapping module further includes a second multiplexer switch, which includes multiple second selectors electrically connected to the ablation electrodes one-to-one. The second selectors are configured to selectively open or close under the control of the control module to select mapping electrodes and detect the electrocardiogram signal of the target tissue through the mapping electrodes.

[0043] Optionally, the pulse ablation system further includes an interlock module electrically connected to the control module and the high-voltage pulse generation module. The mapping module sends a cut-off signal to the control module during mapping and / or when the impedance detection module is detecting. The control module controls the interlock module to cut off the high-voltage pulse signal output of the high-voltage pulse generation module. The control module is also configured to receive the electrocardiogram signal detected by the mapping module and evaluate the treatment effect and / or receive the impedance value detected by the impedance detection module and evaluate the adhesion between the working electrode and the target tissue.

[0044] Optionally, the control module is further configured to control the high-voltage pulse generating module to perform pre-discharge according to the discharge mode, and the pulse ablation system further includes:

[0045] The acquisition module, electrically connected to the pulse ablation catheter, is configured to acquire current and voltage data of the working electrode during pre-discharge.

[0046] The diagnostic module, electrically connected to the acquisition module and the control module, is configured to determine whether the discharge of the working electrode is normal based on the acquired current and voltage data, and to feed back the results to the control module.

[0047] Fourthly, the present invention also provides another pulse ablation system, including a power supply module, a high-voltage pulse generation module, an electrode switching module, a pulse ablation catheter, and a control module; wherein,

[0048] The power supply module is electrically connected to the high-voltage pulse generating module and is configured to supply power to the high-voltage pulse generating module.

[0049] The high-voltage pulse generating module is electrically connected to the pulse ablation catheter and is configured to send a high-voltage pulse signal to the pulse ablation catheter.

[0050] The pulse ablation catheter includes a plurality of ablation electrodes, at least some of which are configured as working electrodes to receive the high-voltage pulse signal and perform ablation treatment on the target tissue.

[0051] The electrode switching module is electrically connected to the high-voltage pulse generating module, the pulse ablation catheter, and the control module. The electrode switching module is configured to receive the high-voltage pulse signal sent by the high-voltage pulse generating module under the control of the control module, and to select the working electrode and switch between positive and negative poles.

[0052] The electrode switching module includes a first-layer combination switch, a second-layer combination switch, and a third-layer combination switch; wherein...

[0053] The input terminals of the first layer combination switch are electrically connected to the positive and negative terminals of the high-voltage pulse signal output, respectively;

[0054] The input terminals of the second-layer combination switch can be switched to correspond to the output terminals of the first-layer combination switch, and the second-layer combination switch is configured to perform the reversal of the positive and negative poles under the control of the control module;

[0055] The third-layer combination switch includes multiple ablation selection switches that correspond one-to-one with the ablation electrodes. The input terminal of the ablation selection switch is electrically connected to the second-layer combination switch, and the output terminal of the ablation selection switch is electrically connected to the corresponding ablation electrode. The third-layer combination switch is configured to select the working electrode and determine the positive and negative values ​​of each working electrode under the control of the control module.

[0056] The pulse ablation system provided by this invention has at least one of the following beneficial effects:

[0057] 1) No additional electrodes or sensors are required. An impedance detection module is added to the existing pulse ablation system hardware. The degree of contact between the working electrode and the target tissue can be obtained by detecting the impedance value between the paired ablation electrodes, including the working electrode. The detection speed is fast and the accuracy is high, with real-time performance.

[0058] 2) A mapping module is also added, which can detect the electrocardiogram signal of the target tissue area for evaluating the treatment subject and the treatment effect;

[0059] 3) By setting up an interlock module, it is possible to ensure that high-voltage pulses are not delivered to the mapping module and impedance detection module during ablation treatment, and to ensure that the high-voltage pulse generation module does not output high-voltage pulse signals during ECG signal detection or impedance detection, thereby enabling each functional module to work independently.

[0060] 4) The control module is also configured to control the high-voltage pulse generation module to pre-discharge according to the discharge mode, quickly assess the current discharge status of the system through low-voltage discharge, detect the integrity of the discharge circuit, and thus ensure the discharge safety of ablation therapy. Attached Figure Description

[0061] Those skilled in the art will understand that the accompanying drawings are provided to better understand the invention and do not constitute any limitation on the scope of the invention. Wherein:

[0062] Figure 1 This is a structural block diagram of a pulse ablation system provided in an embodiment of the present invention;

[0063] Figure 2 This is a schematic diagram of an electrode segment in a contracted state according to an embodiment of the present invention;

[0064] Figure 3 This is a schematic diagram of an electrode segment in a basket state according to an embodiment of the present invention;

[0065] Figure 4 This is a schematic diagram of an electrode segment in a petal-like state according to an embodiment of the present invention;

[0066] Figure 5This is a schematic diagram of the grouping of the outer electrodes provided in an embodiment of the present invention;

[0067] Figure 6 This is a schematic diagram showing the connection of functional modules in a pulse ablation system provided in an embodiment of the present invention.

[0068] in:

[0069] 1-Power supply module; 2-High voltage pulse generation module; 3-Impedance detection module; 4-Pulse ablation catheter; 5-Control module; 6-Human-machine interface; 7-Electrode switching module; 8-Mapping module; 9-Interlock module; 10-Acquisition module; 11-Diagnostic module;

[0070] 40 - Conduit shaft; 41 - Electrode segment; 31 - First multiplexer; 32 - Impedance detection unit; 71 - First layer combination switch; 72 - Second layer combination switch; 73 - Third layer combination switch; 80 - Second multiplexer;

[0071] 400 - Inner shaft; 401 - Outer tube; 410 - Electrode carrier; 411 - Outer electrode; 412 - Inner electrode; 413 - End electrode;

[0072] 411-1 - First outer electrode; 411-2 - Second outer electrode; 411-3 - Third outer electrode; 411-4 - Fourth outer electrode; 411-5 - Fifth outer electrode; 411-6 - Sixth outer electrode; 411-7 - Seventh outer electrode; 411-8 - Eighth outer electrode; 411-9 - Ninth outer electrode; 411-10 - Tenth outer electrode; 411-11 - Eleventh outer electrode; 411-12 - Twelfth outer electrode; 411-13 - Thirteenth outer electrode; 411-14 - Fourteenth outer electrode; 411-15 - Fifteenth outer electrode. Detailed Implementation

[0073] To make the objectives, advantages, and features of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. It should be noted that the drawings are in a very simplified form and use non-precise proportions, and are only used to facilitate and clearly illustrate the purpose of the embodiments of this invention. Please refer to the accompanying drawings to make the objectives, features, and advantages of this invention more apparent and understandable. It should be understood that the structures, proportions, sizes, etc., depicted in the accompanying drawings are only used to complement the content disclosed in the specification, for those skilled in the art to understand and read, and are not intended to limit the implementation conditions of this invention. Any modifications to the structure, changes in proportions, or adjustments to the size, if they are the same as or similar to the effects and objectives achieved by this invention, should still fall within the scope of the technical content disclosed in this invention.

[0074] As used herein, the singular forms “a,” “an,” and “the” include plural objects unless otherwise expressly indicated. As used herein, the term “or” is generally used to include “and / or” unless otherwise expressly indicated. As used herein, the term “a number” is generally used to include “at least one” unless otherwise expressly indicated. As used herein, the term “at least two” is generally used to include “two or more” unless otherwise expressly indicated. Furthermore, the terms “first,” “second,” and “third” are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined as “first,” “second,” or “third” may explicitly or implicitly include one or at least two of that feature.

[0075] In the description of this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," and "fixing" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0076] Firstly, please refer to Figure 1 This invention provides a pulse ablation system for ablating target tissue, comprising a power supply module 1, a high-voltage pulse generation module 2, an impedance detection module 3, a pulse ablation catheter 4, and a control module 5; wherein,

[0077] Power supply module 1 is electrically connected to high voltage pulse generation module 2 and is configured to supply power to high voltage pulse generation module 2;

[0078] The high-voltage pulse generation module 2 is electrically connected to the pulse ablation catheter 4 and the impedance detection module 3, and is configured to send a high-voltage pulse signal to the pulse ablation catheter 4.

[0079] The pulse ablation catheter 4 includes a catheter shaft 40 and an electrode segment 41 disposed at the distal end of the catheter shaft 40. The electrode segment 41 includes an electrode assembly, which includes at least one electrode carrier and a plurality of ablation electrodes located on the electrode carrier 410. The ablation electrodes include an outer electrode 411. In the initial state, the working surface of the outer electrode 411 faces away from the catheter shaft 40, and the working surface of the inner electrode 412 faces the catheter shaft 40. At least some of the ablation electrodes are configured as working electrodes to receive high-voltage pulse signals and perform ablation treatment on the target tissue.

[0080] Impedance detection module 3, electrically connected to pulse ablation catheter 4 and control module 5, is configured to select paired ablation electrodes and detect the impedance value between paired ablation electrodes under the control of control module 5, wherein at least one of the paired ablation electrodes is a working electrode.

[0081] The control module 5 is configured to receive the impedance value detected by the impedance detection module 3 and evaluate the degree of contact between the working electrode and the target tissue.

[0082] The embodiments of the present invention do not require additional electrodes and sensors. The degree of adhesion between the working electrode and the target tissue can be obtained by detecting the impedance value between the paired ablation electrodes, including the working electrode. The detection speed is fast and the accuracy is high, and it is real-time.

[0083] It is important to understand that the terms "proximal" and "distal" in this article are defined as follows: "proximal" usually refers to the end of the medical device that is closest to the operator during normal operation, while "distal" usually refers to the end of the medical device that first enters the patient's body during normal operation.

[0084] For details, please refer to Figures 2-4 As a preferred example in this embodiment, at least one of the ablation electrodes in the pulse ablation catheter is the outer electrode 411.

[0085] As another preferred example in this embodiment, the outer electrode 411 is disposed near the distal end of the electrode carrier 410 and the inner electrode 412 is disposed near the proximal end of the electrode carrier 410, and the ablation electrodes involved in the pairing are the inner electrode 412 and / or the outer electrode 411.

[0086] Furthermore, electrode segment 41 also includes end electrode 413, which is disposed at the distal end of catheter shaft 40. One of the paired ablation electrodes is end electrode 413, and the other is outer electrode 411.

[0087] In this embodiment, the proximal and distal ends of the electrode carrier 410 are connected to the catheter shaft 40 and can move relative to each other on the catheter shaft 40, so that the electrode segment 41 can switch between a contracted state and an expanded state. The expanded state includes a basket state and a petal state. The pulse ablation system has treatment modes corresponding to different states of the electrode segment 41. Depending on the different shapes of the electrode segment 41, the pulse ablation system has different ablation treatment modes.

[0088] For example, in the contracted state, the electrode carrier 410 is attached to the outer wall of the catheter shaft 40, the working surface of the outer electrode 411 faces away from the catheter shaft 40, and the working surface of the inner electrode 412 faces the catheter shaft 40. The pulse ablation system has a head-end treatment mode corresponding to the contracted state. In the contracted state, the working electrode is the end electrode 413. The end electrode 413 is paired with the inner electrode 412 to perform ablation treatment. When performing impedance detection, the end electrode 413 is paired with the outer electrode 411.

[0089] Preferably, in the contracted state, the outer electrodes 411 located on the same electrode carrier 410 are divided into an outer electrode group, and the end electrode 413 is paired with each outer electrode group in turn to detect the impedance value between the end electrode 413 and the corresponding outer electrode 411.

[0090] In the basket state, the electrode carrier 410 is in an expanded state, and the working surface of the outer electrode 411 is at least partially facing the distal end of the catheter axis 40. The pulse ablation system has a basket treatment mode corresponding to the basket state. In the basket state, the working electrode is the outer electrode 411 and / or the end electrode 413. In this state, since the end electrode 413 is more prominent than the outer electrode 411, the degree of contact between the outer electrode 411 and the target tissue can be detected to reflect the degree of contact between the end electrode 413 and the target tissue.

[0091] In the petal state, the electrode carrier 410 is in an expanded state, and the working surfaces of the outer electrode 411 and the inner electrode 412 are both facing the distal end of the catheter axis 40. The pulse ablation system has a petal treatment mode corresponding to the petal state. The working electrodes are the outer electrode 411 and / or the inner electrode 412. When performing impedance detection, the outer electrode 411 is paired with the inner electrode 412, or the outer electrode 411 is paired with the inner electrode 412.

[0092] Furthermore, the proximal and distal ends of the electrode carrier 410 are connected to the catheter shaft 40 and can move relative to it, allowing the electrode segment 41 to switch between a contracted and an expanded state. In the expanded state, with the distal end of the catheter shaft 40 as the center, ablation electrodes within the same outer diameter range are divided into an electrode group. Paired ablation electrodes within each electrode group are paired alternately at fixed intervals. Through axial grouping of the electrodes, the degree of electrode contact can be dynamically monitored in real time based on changes in local impedance.

[0093] Specifically, the expansion state includes the basket state or the petal state. In the basket state, the main focus is on detecting the degree of contact between the outer electrode 411 and the target tissue. Therefore, the outer electrodes 411 located within the same outer diameter range can be divided into an outer electrode group with the distal end of the catheter shaft 40 as the center. The paired ablation electrodes in each outer electrode group are paired in turn at fixed intervals.

[0094] like Figure 5 As shown, assume that the outer electrode 411 is divided into three groups: the first outer electrode group includes the first outer electrode 411-1, the second outer electrode 411-2, the third outer electrode 411-3, the fourth outer electrode 411-4, and the fifth outer electrode 411-5; the second outer electrode group includes the sixth outer electrode 411-6, the seventh outer electrode 411-7, the eighth outer electrode 411-8, the ninth outer electrode 411-9, and the tenth outer electrode 411-10; and the third outer electrode group includes the eleventh outer electrode 411-11, the twelfth outer electrode 411-12, the thirteenth outer electrode 411-13, the fourteenth outer electrode 411-14, and the fifteenth outer electrode 411-15. Each group of outer electrodes is paired separately and impedance values ​​are detected.

[0095] Specifically, for each outer electrode group, every two outer electrodes 411 are paired alternately at a fixed interval. The number of pairs is the same as the number of electrodes (i.e., five outer electrodes correspond to five pairs). The impedance value between the paired electrodes is detected. Taking the first outer electrode group as an example, if the pairing interval is 0, the paired electrodes are the first outer electrode 411-1 and the second outer electrode 411-2, the second outer electrode 411-2 and the third outer electrode 411-3, the third outer electrode 411-3 and the fourth outer electrode 411-4, and the fourth outer electrode 411-5. Electrode 411-4 and fifth outer electrode 411-5, fifth outer electrode 411-5 and first outer electrode 411-1; if the pairing interval is 1, the paired electrodes are respectively first outer electrode 411-1 and third outer electrode 411-3, second outer electrode 411-2 and fourth outer electrode 411-4, third outer electrode 411-3 and fifth outer electrode 411-5, fourth outer electrode 411-4 and first outer electrode 411-1, fifth outer electrode 411-5 and second outer electrode 411-2. Impedance detection module 3 detects the impedance value of each pair of paired electrodes to determine the degree of contact between the first outer electrode 411-1 group and the lateral region. It should be understood that the pairing interval can be set according to the number of electrodes, and this application does not limit it. Theoretically, the smaller the pairing interval, the higher the measurement accuracy of the impedance value, and the easier it is to determine the degree of contact between the outer electrode and the target tissue.

[0096] Alternatively, in the basket configuration, the outer electrodes 411 located on the same electrode carrier 410 can be divided into an outer electrode group and paired with the end electrodes 413 respectively. This allows for more accurate determination of which outer electrode 412 on the electrode carrier 410 paired with the end electrode 413 is in contact with the tissue and which outer electrode 412 on the electrode carrier 410 is located in the blood, thereby improving the reliability of the contact degree detection. The outer electrodes 411 located on the same electrode carrier 410 can also be paired alternately to further improve the reliability of the contact degree detection.

[0097] In the petal state, the working electrodes are the outer electrode 411 and the inner electrode 412, and the electrode carrier 410 has the largest expansion outer diameter. Compared with the basket state, the contact degree detection in the petal state adds the pairing impedance detection of the inner electrode 412. At the same time, the electrode grouping in the petal state can be carried out in the same way as in the basket state, with the outer electrodes 411 in each group paired with each other, and the inner electrodes 412 in each group paired with each other.

[0098] Preferably, in the petal state, with the distal end of the catheter shaft 40 as the center, the outer electrodes 411 within the same outer diameter range are divided into outer electrode groups, and the inner electrodes 412 within the same outer diameter range are divided into inner electrode groups. Paired ablation electrodes within each outer electrode group are paired alternately at fixed intervals, and paired ablation electrodes within each inner electrode group are paired alternately at fixed intervals; and / or,

[0099] In the petal state, the outer electrodes 411 located on the same electrode carrier 410 are divided into an outer electrode group, and the inner electrodes 412 located on the same electrode carrier 410 are divided into an inner electrode group. Paired ablation electrodes within each outer electrode group are paired alternately at fixed intervals, and paired ablation electrodes within each inner electrode group are paired alternately at fixed intervals; and / or,

[0100] In the petal state, electrodes located within the same outer diameter range are grouped together, that is, the inner and outer electrodes within the same outer diameter range are grouped together, in order to further understand the contact status of the working electrode area within the same outer diameter range.

[0101] Preferably, the conduit shaft 40 includes, for example, an inner shaft 400 and an outer tube 401, with the proximal end of the carrier disposed on the outer tube 401 and the distal end of the carrier disposed on the inner shaft 400. By driving the inner shaft 400 and the outer tube 401 to move relative to each other, the electrode carrier 410 can switch between a contracted state and an expanded state.

[0102] Preferably, the outer tube 401 is sleeved on the inner shaft 400. Preferably, the inner shaft 400 and the outer shaft can be woven from materials such as polyurethane, Pebax (polyether block polyamide), and polyimide.

[0103] Preferably, the impedance detection module 3 is further configured to detect the impedance values ​​between the paired electrodes before and after the working electrode is attached to the target tissue, to overcome individual differences caused by the patient. Detecting the impedance value of the paired electrodes before the working electrode is attached to the tissue obtains the initial impedance value of the paired electrodes when they come into contact with blood, thereby obtaining the patient's initial attachment data. Since the closer the working electrode is to the target tissue, the greater the increase in impedance value, the impedance value of the paired electrodes can be detected after the working electrode is attached to the tissue, so as to determine the degree of attachment of each electrode by the change in impedance value before and after attachment.

[0104] In practical applications, before measuring the contact impedance of each paired electrode, it is necessary to obtain the initial impedance value of the paired electrode in the blood. However, this initial impedance value varies for different patients and in different tissues. Moreover, during the measurement process, the outer electrode 411 may come into contact with other tissues, leading to inaccurate initial impedance measurements. To address this issue, this application provides a method for obtaining the initial impedance value by measuring the impedance value between paired inner electrodes 412, based on the characteristic that the inner electrode 412 is less likely to come into contact with tissues. First, to obtain the mapping relationship between the impedance values ​​of each paired electrode and the impedance value of the inner electrode 412, the initial impedance value between the inner electrodes 412 is measured and recorded during the production of the pulse ablation catheter 4. This can be the average value of all adjacent inner electrodes 412 in a stable electrolyte solution. Then, the initial impedance value of each paired electrode in a stable electrolyte solution is measured. Based on the ratio between the initial impedance values ​​of other paired electrodes and the initial impedance values ​​of the paired inner electrodes 412, the mapping ratio between them is determined. Next, when the pulse ablation catheter 4 enters the patient's body, the impedance value between the paired inner electrodes 412 is obtained when the patient is in a contracted (or dilated) state. Then, the impedance values ​​of other paired electrodes in the blood and the threshold for contact determination are determined according to the corresponding mapping relationship.

[0105] In this embodiment, please refer to Figure 6 The impedance detection module 3 further includes a first multiplexer 31, which comprises multiple first selection switches that correspond one-to-one with and are electrically connected to the ablation electrodes. These first selection switches are configured to selectively open or close under the control of the control module 5, thereby enabling electrical connection between the impedance detection module 3 and the paired ablation electrodes. In this embodiment, the impedance detection module 3 includes several impedance detection units 32, each unit being used to detect the impedance value between each paired ablation electrode.

[0106] For example, in the contracted state, the end electrode 413 is the working electrode. The control module 5 can control the activation of the first selection switch corresponding to the end electrode 413. Simultaneously, the control module 5 also controls the first selection switches of each outer electrode 411 paired with the end electrode 413, achieving pairing of the end electrode 413 with each outer electrode 411. This allows for polling and detecting the impedance values ​​of the end electrode 413 and the outer electrodes 411, thus facilitating the determination of the degree of contact between the end electrode 413 and the target tissue. It should be understood that since only the end electrode 413 is the working electrode in the contracted state, as long as an impedance value indicating complete contact between the end electrode 413 and the target tissue is obtained, it can be determined that the end electrode 413 is completely in contact with the target tissue. The different impedance values ​​obtained between different outer electrodes 411 and the end electrode 413 can be used to reflect the contact status of the outer electrodes 411.

[0107] For example, assuming the impedance of the end electrode 413 in blood is 500 ohms, if the detected impedance between the end electrode 413 and at least one outer electrode 411 is 600 ohms, it is determined that both the end electrode 413 and the outer electrode 411 are completely in contact with the tissue. If the detected impedance between the end electrode 413 and the outer electrode 411 is 550 ohms, it is determined that the working electrode is partially in contact with the target tissue; that is, the better the contact, the higher the resistance. If the detected impedance between the end electrode 413 and at least one outer electrode 411 is 600 ohms, and simultaneously the detected impedance between the end electrode 413 and a portion of the outer electrode 411 is less than 600 ohms, it indicates that the outer electrode 411 is partially in contact with the target tissue.

[0108] Furthermore, the control module 5 can also control the first multiplexer 31 to detect the impedance values ​​of the end electrode 413 and the outer electrode 411 in batches. For example, the outer electrode 411 can be divided into multiple outer electrode groups. The end electrode 413 is first paired with the first outer electrode group, and the detected impedance value of that group is sent to the control module 5. Then it is paired with the second outer electrode group, and the detected impedance value of that group is sent to the control module 5, until the pairing and detection of all outer electrode groups is completed. In this way, the degree of contact between the end electrode 413 and each outer electrode 411 and the target tissue can be determined in three dimensions.

[0109] Preferably, the pulse ablation system also includes a human-machine interface 6 electrically connected to the control module 5. When the impedance detection module 3 detects the impedance value of the paired electrodes and transmits it to the control module 5, the control module 5 can establish a three-dimensional model of the pulse ablation catheter based on the impedance value according to the electrode morphology in the treatment mode. This three-dimensional model can display the degree of contact between each electrode and the tissue based on the impedance value, and can be displayed on the human-machine interface 6 through the transmission of the control module 5.

[0110] Furthermore, the control module 5 can combine real-time imaging data of the tissue to display the degree of adhesion between the electrode and the tissue in real time on the human-computer interaction interface 6, and guide the user on how to adjust the electrode segment 41 to improve the adhesion effect.

[0111] In this embodiment, the control module 5 can identify the treatment mode by reading the position of the push-pull component on the operating handle of the pulse ablation catheter 4, or by inputting through the human-machine interface 6, or by a combination of both. This application does not limit this.

[0112] Please continue to refer to Figure 1 The pulse ablation system also includes an electrode switching module 7, which is electrically connected to the high-voltage pulse generation module 2, the pulse ablation catheter 4, and the control module 5. The electrode switching module 7 is configured to receive the high-voltage pulse signal sent by the high-voltage pulse generation module 2 under the control of the control module 5, and to select the working electrode and switch between positive and negative poles.

[0113] Preferred, combined Figure 6 The electrode switching module 7 includes a first-layer combination switch 71, a second-layer combination switch 72, and a third-layer combination switch 73; wherein,

[0114] The input terminals of the first-level combination switch 71 are electrically connected to the positive and negative terminals of the high-voltage pulse signal output, respectively;

[0115] The input terminals of the second-layer combination switch 72 can be switched to correspond to the output terminals of the first-layer combination switch 71. The second-layer combination switch 72 is configured to perform positive and negative reversal under the control of the control module 5.

[0116] The third-layer combination switch 73 includes multiple ablation selection switches corresponding to ablation electrodes. The input terminals of the ablation selection switches are electrically connected to the second-layer combination switch, and the output terminals of the ablation selection switches are electrically connected to the corresponding ablation electrodes. The third-layer combination switch 73 is configured to select the working electrodes and determine the positive and negative values ​​of each working electrode under the control of the control module.

[0117] In this embodiment, the first-layer combination switch 71 includes two control switches. The input terminals of the two control switches are electrically connected to the positive and negative terminals of the high-voltage pulse signal output, respectively. The first-layer combination switch 71 can select the positive and negative terminals according to the discharge requirements to ensure the stability of the discharge, and can also cut off the output of the high-voltage pulse signal in time under abnormal conditions. For example, when the second-layer combination switch 72 and / or the third-layer combination switch 73 need to disconnect the pulse output, but cannot disconnect in time due to problems such as adhesion or damage, or when the system malfunctions, the output of the high-voltage pulse signal can be cut off by controlling the disconnection of the first-layer combination switch 71, thereby ensuring the safety of the treatment. The second-layer combination switch 72 includes two reversing switches. The input terminals of the two reversing switches can be switched to correspond to the output terminals of the two control switches. The second-layer combination switch 72 is configured to perform positive and negative reversal under the control of the control module 5.

[0118] For the preferred options, please continue to refer to [the relevant documentation / reference]. Figure 1 The pulse ablation system also includes a mapping module 8, which is electrically connected to the pulse ablation catheter 4 and the control module 5. The mapping module 8 is configured, under the control of the control module 5, to select at least some of the ablation electrodes as mapping electrodes to detect the electrocardiogram (ECG) signal of the target tissue. The mapping module 8 can detect the ECG signal of the target tissue area and transmit the ECG signal to a multichannel instrument to evaluate the treatment recipient and the treatment effect.

[0119] Furthermore, the mapping module 8 also includes a second multiplexer 80, which includes multiple second selection switches that are electrically connected one-to-one with the ablation electrodes. The second selection switches are configured to selectively open or close under the control of the control module 5 to select mapping electrodes and detect the electrocardiogram signal of the target tissue through the mapping electrodes.

[0120] Please refer to Figure 6 The pulse ablation system also includes an interlock module 9, which is electrically connected to the impedance detection module 3, the mapping module 8, and the control module 5. The mapping module 8 sends a cutoff signal to the control module 5 during mapping and / or impedance detection module 3 detection. The control module 5 controls the interlock module 9 to cut off the high-voltage pulse signal output of the high-voltage pulse generation module 2. The control module 5 is also configured to receive the electrocardiogram signal detected by the mapping module and evaluate the treatment effect, and / or receive the impedance value detected by the impedance detection module and evaluate the adhesion between the working electrode and the target tissue. The interlock module 9 ensures that high-voltage pulses are not delivered to the mapping module 8 and the impedance detection module 3 during ablation treatment, and ensures that the high-voltage pulse generation module 2 does not output a high-voltage pulse signal during electrocardiogram or impedance detection.

[0121] In this embodiment, when the pulse ablation system is working, electrode segment 41 is placed in the target tissue area. The treatment mode is selected, and the corresponding working state of electrode segment 41 (contraction state, basket state, and petal state) is determined. The control module 5 controls the second multiplexer 80 to electrically connect the mapping module 8 to the selected working electrode according to the treatment mode. At this time, the mapping module 8 sends a mapping interlock signal to the interlock module 9. After receiving the mapping interlock signal, the interlock module 9 cuts off the high-voltage pulse signal output of the high-voltage pulse generation module 2. The mapping module 8 detects the electrocardiogram signal of the target tissue area and transmits it to the control module 5 to confirm the treatment area. The control module 5 can identify the treatment mode by reading the position of the push-pull component on the operating handle of the pulse ablation catheter 4, by inputting through the human-machine interface, or a combination of both. After confirming the treatment area, the control module 5 controls the first multiplexer 31 to electrically connect the impedance detection module 3 to the selected working electrode according to the treatment mode. At this time, the impedance detection module 3 sends an impedance detection interlock signal to the interlock module 9. After receiving the impedance detection interlock signal, the interlock module 9 sends a signal to the control module 5. The control module 5 controls the second multiplexer 80 to disconnect the electrical connection between the mapping module 8 and the working electrode. The impedance detection module 3 detects the impedance value of the paired electrode and transmits it to the control module 5 to confirm the degree of contact between the working electrode and the target tissue. Based on the detection result, the control module 5 adjusts the contact between the working electrode and the target tissue. When the working electrode and the target tissue reach the expected degree of contact, the control module 5 controls the first multiplexer 31 and the second multiplexer 80 to disconnect the electrical connection between the mapping module 8 and the impedance detection module 3 and the working electrode. Then, the control module 2 outputs a high-voltage pulse signal that passes through the first layer combination switch 71, the second layer combination switch 72, and the third layer combination switch 73 to the working electrode to perform ablation treatment on the target tissue. After ablation treatment, the control module 5 controls the second multiplexer 80 to electrically connect the mapping module 8 to the selected working electrode. At this time, the mapping module 8 sends a mapping interlock signal to the interlock module 9. After receiving the mapping signal, the interlock module 9 cuts off the high voltage pulse signal output of the high voltage pulse generation module 2. The mapping module 8 then detects the electrocardiogram signal and confirms the treatment effect.

[0122] Furthermore, control module 5 is also configured to control high-voltage pulse generation module 2 to perform pre-discharge according to the discharge mode. This allows for rapid assessment of the system's current discharge status through lower voltage discharge, detection of the discharge circuit's integrity, and thus ensures the safety of subsequent ablation treatment. The pulse ablation system also includes:

[0123] The acquisition module 10 is electrically connected to the pulse ablation catheter 4 and is configured to acquire the current and voltage data of the working electrode during pre-discharge.

[0124] The diagnostic module 11 is electrically connected to the acquisition module 10 and the control module 5. It is configured to determine whether the discharge of the working electrode is normal based on the acquired current and voltage data, and to feed back the results to the control module 5.

[0125] The difference between pre-discharge and formal discharge is that the voltage and number of energy output pulses used in pre-discharge are different. By collecting feedback information such as the current and voltage of the system during pre-discharge, the discharge situation can be evaluated, such as discharge short circuit, open circuit, pulse number error, etc. This can effectively avoid surgical interruption caused by problems such as short circuit of certain electrodes of the pulse ablation catheter 4, improve surgical ablation efficiency and reduce surgical time.

[0126] The pre-discharge process is roughly as follows:

[0127] S1. After the pre-discharge begins, first control the voltage of power supply module 1 to a very low voltage (generally not higher than 500V).

[0128] S2. Perform pre-discharge according to the normal treatment discharge mode. The pre-discharge mode is the same as the formal discharge mode, but the number of pulses can be adjusted to 10 or less, and the discharge interval (the interval between each pulse group) is set to a relatively low interval such as 50ms-200ms, so that a rapid discharge check can be completed;

[0129] S3. Collect data such as voltage and current of the working electrode;

[0130] S4. Determine whether the system discharge is normal based on the collected voltage and current data. For example, whether the actual discharge voltage is the predetermined voltage; whether the current is neither too large nor too small (too large a current indicates a short circuit in the electrode or other reasons, while too small a current indicates an open circuit in the currently detected electrode combination); and whether the number of discharge pulses is abnormal.

[0131] In addition, the system can shut down the discharge of only one or two groups of electrodes if only one or two groups are abnormal, while the other groups discharge normally, based on the feedback of the electrode combination. If the system detects three or more abnormal discharge groups, it will not allow the system to continue discharging and will prompt the system to replace the pulse ablation catheter 4 or adjust the status of the pulse ablation catheter 4.

[0132] Secondly, embodiments of the present invention provide a pulse ablation system for ablating target tissue, comprising a power supply module 1, a high-voltage pulse generation module 2, a mapping module 8, a pulse ablation catheter 4, a control module 5, and an interlocking module 9; wherein...

[0133] Power supply module 1 is electrically connected to high voltage pulse generation module 2 and is configured to supply power to high voltage pulse generation module 2;

[0134] The high-voltage pulse generation module 2 is electrically connected to the pulse ablation catheter 4 and the mapping module 8, and is configured to send a high-voltage pulse signal to the pulse ablation catheter 4.

[0135] The pulse ablation catheter 4 includes several ablation electrodes, at least some of which are configured as working electrodes to receive high-voltage pulse signals and perform ablation treatment on the target tissue.

[0136] The mapping module 8 is electrically connected to the pulse ablation catheter 4 and the control module 5, and is configured to select at least some of the ablation electrodes as mapping electrodes under the control of the control module 5 to detect the electrocardiogram signal of the target tissue.

[0137] Interlock module 9 is electrically connected to control module 5 and high-voltage pulse generation module 2. During mapping, mapping module 8 sends a cut-off signal to control module 5. Control module 5 controls interlock module 9 to cut off the high-voltage pulse signal output of high-voltage pulse generation module 2, and receives the electrocardiogram signal detected by mapping module 8 to evaluate the treatment effect.

[0138] Thirdly, the present invention provides yet another pulse ablation system, comprising a power supply module 1, a high-voltage pulse generation module 2, a data acquisition module 10, a diagnostic module 11, a pulse ablation catheter 4, and a control module 5; wherein,

[0139] Power supply module 1 is electrically connected to high voltage pulse generation module 2 and is configured to supply power to high voltage pulse generation module 2;

[0140] The high-voltage pulse generation module 2 is electrically connected to the pulse ablation catheter 4 and is configured to send a high-voltage pulse signal to the pulse ablation catheter 4.

[0141] The pulse ablation catheter 4 includes several ablation electrodes, at least some of which are configured as working electrodes to receive high-voltage pulse signals and perform ablation treatment on the target tissue.

[0142] Control module 5 is configured to control high voltage pulse generation module 2 to perform pre-discharge according to the discharge mode. During pre-discharge, the working voltage provided by power supply module 1 is less than the working voltage provided by power supply module 1 during ablation treatment.

[0143] The acquisition module 10 is electrically connected to the pulse ablation catheter 4 and is configured to acquire the current and voltage data of the working electrode during pre-discharge.

[0144] The diagnostic module 11 is electrically connected to the acquisition module 10 and the control module 5, and is configured to determine whether the working electrode discharge is normal based on the acquired current and voltage data, and to feed back to the control module 5.

[0145] Fourthly, the present invention provides yet another pulse ablation system, comprising a power supply module 1, a high-voltage pulse generation module 2, an electrode switching module 7, a pulse ablation catheter 4, and a control module 5; wherein,

[0146] Power supply module 1 is electrically connected to high voltage pulse generation module 2 and is configured to supply power to high voltage pulse generation module 2;

[0147] The high-voltage pulse generation module 2 is electrically connected to the pulse ablation catheter 4 and is configured to send a high-voltage pulse signal to the pulse ablation catheter 4.

[0148] The pulse ablation catheter 4 includes several ablation electrodes, at least some of which are configured as working electrodes to receive high-voltage pulse signals and perform ablation treatment on the target tissue.

[0149] Electrode switching module 7 is electrically connected to high voltage pulse generation module 2, pulse ablation catheter 4 and control module 5. Electrode switching module 7 is configured to receive high voltage pulse signal sent by high voltage pulse generation module 2 under the control of control module 5, and to select working electrode and switch positive and negative electrodes.

[0150] Electrode switching module 7 includes a first-layer combination switch 71, a second-layer combination switch 72, and a third-layer combination switch 73; wherein,

[0151] The input terminals of the first-level combination switch 71 are electrically connected to the positive and negative terminals of the high-voltage pulse signal output, respectively;

[0152] The input terminals of the second-layer combination switch 72 can be switched to correspond to the output terminals of the first-layer combination switch 71. The second-layer combination switch 72 is configured to perform positive and negative reversal under the control of the control module 5.

[0153] The third-layer combination switch 73 includes multiple ablation selection switches corresponding to ablation electrodes. The input terminals of the ablation selection switches are electrically connected to the second-layer combination switch 72, and the output terminals of the ablation selection switches are electrically connected to the corresponding ablation electrodes. The third-layer combination switch 73 is configured to select the working electrodes and determine the positive and negative values ​​of each working electrode under the control of the control module 5.

[0154] In summary, this invention provides a pulse ablation system that does not require additional electrodes or sensors. It adds an impedance detection module to the existing pulse ablation system hardware, and the degree of contact between the working electrode and the target tissue can be obtained by detecting the impedance value between the paired electrodes, including the working electrode. The detection speed is fast and the accuracy is high, and it has real-time performance.

[0155] The above description is merely a description of preferred embodiments of the present invention and is not intended to limit the scope of the invention in any way. Any changes or modifications made by those skilled in the art based on the above disclosure are within the protection scope of the present invention. Obviously, those skilled in the art can make various modifications and variations to the present invention without departing from its spirit and scope. Therefore, if these modifications and variations fall within the scope of the present invention and its equivalents, the present invention also intends to include these modifications and variations.

Claims

1. A pulse ablation system, characterized in that, It includes a power supply module, a high-voltage pulse generation module, an electrode switching module, a pulse ablation catheter, and a control module; among which, The power supply module is electrically connected to the high-voltage pulse generating module and is configured to supply power to the high-voltage pulse generating module. The high-voltage pulse generating module is electrically connected to the pulse ablation catheter and is configured to send a high-voltage pulse signal to the pulse ablation catheter. The pulse ablation catheter includes a plurality of ablation electrodes, at least some of which are configured as working electrodes to receive the high-voltage pulse signal and perform ablation treatment on the target tissue. The electrode switching module is electrically connected to the high-voltage pulse generating module, the pulse ablation catheter, and the control module. The electrode switching module is configured to receive the high-voltage pulse signal sent by the high-voltage pulse generating module under the control of the control module, and to select the working electrode and switch between positive and negative poles. The electrode switching module includes a first-layer combination switch, a second-layer combination switch, and a third-layer combination switch; wherein... The input terminals of the first layer combination switch are electrically connected to the positive and negative terminals of the high-voltage pulse signal output, respectively; The input terminals of the second-layer combination switch can be switched to correspond to the output terminals of the first-layer combination switch, and the second-layer combination switch is configured to perform the reversal of the positive and negative poles under the control of the control module; The third-layer combination switch includes multiple ablation selection switches that correspond one-to-one with the ablation electrodes. The input terminal of the ablation selection switch is electrically connected to the second-layer combination switch, and the output terminal of the ablation selection switch is electrically connected to the corresponding ablation electrode. The third-layer combination switch is configured to select the working electrode and determine the positive and negative values ​​of each working electrode under the control of the control module.

2. The pulse ablation system according to claim 1, characterized in that, It also includes a calibration module and an interlock module; among which, The mapping module is electrically connected to the pulse ablation catheter and the control module, and is configured to select at least a portion of the ablation electrodes as mapping electrodes under the control of the control module to detect the electrocardiogram signal of the target tissue. The interlock module is electrically connected to the control module and the high-voltage pulse generation module. During mapping, the mapping module sends a cut-off signal to the control module. The control module controls the interlock module to cut off the high-voltage pulse signal output of the high-voltage pulse generation module, and receives the electrocardiogram signal detected by the mapping module to evaluate the treatment effect.

3. The pulse ablation system according to claim 1, characterized in that, It also includes a data acquisition module and a diagnostic module; among which, The control module is configured to control the high-voltage pulse generation module to perform pre-discharge according to the discharge mode. During pre-discharge, the working voltage provided by the power supply module is less than the working voltage provided by the power supply module during ablation treatment. The acquisition module is electrically connected to the pulse ablation catheter and is configured to acquire the current and voltage data of the working electrode during pre-discharge. The diagnostic module is electrically connected to the acquisition module and the control module, and is configured to determine whether the discharge of the working electrode is normal based on the acquired current and voltage data, and to feed back to the control module.

4. The pulse ablation system according to any one of claims 1-3, characterized in that, The pulse ablation system also includes a human-machine interface electrically connected to the control module. The control module is further configured to establish a three-dimensional model of the pulse ablation catheter based on impedance values ​​according to the electrode morphology in the treatment mode, and display it through the human-machine interface.

5. The pulse ablation system according to claim 1, characterized in that, The pulse ablation system further includes a mapping module, which is electrically connected to the pulse ablation catheter and the control module. The mapping module is configured to select at least a portion of the ablation electrodes as mapping electrodes under the control of the control module to detect the electrocardiogram signal of the target tissue.

6. The pulse ablation system according to claim 2, characterized in that, The mapping module further includes a second multiplexer, which includes multiple second selectors that are electrically connected to the ablation electrodes one by one. The second selectors are configured to selectively open or close under the control of the control module to select mapping electrodes and detect the electrocardiogram signal of the target tissue through the mapping electrodes.

7. The pulse ablation system according to claim 1, characterized in that, The control module is further configured to control the high-voltage pulse generating module to perform pre-discharge according to the discharge mode, and the pulse ablation system further includes: The acquisition module, electrically connected to the pulse ablation catheter, is configured to acquire current and voltage data of the working electrode during pre-discharge. The diagnostic module, electrically connected to the acquisition module and the control module, is configured to determine whether the discharge of the working electrode is normal based on the acquired current and voltage data, and to feed back the results to the control module.

8. The pulse ablation system according to claim 3, characterized in that, If the number of abnormal discharges at the working electrode is not less than 3, the pulse ablation system is not allowed to continue discharging.

9. The pulse ablation system according to any one of claims 1-3, characterized in that, The pulse ablation system further includes an impedance detection module, which is electrically connected to the pulse ablation catheter and the control module, and is configured to select paired ablation electrodes and detect the impedance value between the paired ablation electrodes under the control of the control module, wherein at least one of the paired ablation electrodes is the working electrode. The control module is also configured to receive the impedance value detected by the impedance detection module and evaluate the degree of contact between the working electrode and the target tissue.

Images