Electrode carriers, electrophysiological catheters, and high-voltage pulse ablation systems

Abstract

This invention provides an electrode carrier, an electrophysiological catheter, and a high-voltage pulse ablation system. The electrophysiological catheter includes a catheter shaft and an electrode segment, the electrode segment being disposed at the distal end of the catheter shaft. The electrode segment includes a terminal electrode and an electrode assembly, the electrode assembly being closer to the proximal end of the catheter shaft than the terminal electrode. The electrode assembly includes at least one electrode carrier and a plurality of electrodes located on the electrode carrier. When the terminal electrode ablates the target tissue, the terminal electrode pairs with at least one of the electrodes to discharge, and at least one of the electrodes participating in the paired discharge is located on the side of the electrode carrier near the catheter shaft. When the terminal electrode is used to ablate the target tissue, this invention enables the paired electrodes to face away from or at least make it difficult for them to contact non-target tissue, thereby preventing the paired electrodes from acting on non-target tissue to form unintended ablation foci.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an electrode carrier, an electrophysiological catheter, and a high-voltage pulse ablation system. Background Technology

[0002] Atrial fibrillation (AF) is one of the most common arrhythmias in clinical practice. Pulsed electric field (PEF) ablation is a relatively new method for AF ablation. In PEF ablation, a pulsed electric field is delivered to the myocardial tissue via a catheter electrode. The pulsed electric field induces irreversible electroporation, increasing cell permeability and leading to cell death and the formation of an ablation focus. Compared to traditional radiofrequency ablation and cryoablation, PEF ablation is a non-thermal ablation technique, and its cell selectivity makes it safer for AF treatment.

[0003] Pulsed electric field ablation surgery is a vascular interventional procedure in which the distal end of a catheter is inserted into the body to reach the corresponding treatment target. Energy media (such as radiofrequency, ultrasound, pulse, etc.) are sent through an energy platform connected to the proximal end of the catheter. The distal end of the catheter is equipped with an energy delivery electrode. After the electrode is in contact with the tissue, it transfers energy to the tissue, thereby performing tissue ablation.

[0004] The catheter's structure primarily consists of a polymer tubing combined with a ring electrode assembly. A certain number of electrode assemblies are circumferentially arranged on the catheter axis to form electrode segments. Relative movement of the catheter axis allows these electrode segments to switch between contracted, basket-like, and petal-like states, adapting to different vascular anatomy structures for better treatment. Simultaneously, to compensate for the limitations of small-area ablation by the electrode segments, a distal electrode is placed at the distal end. The distal electrode employs unipolar and multipolar ablation modes. Unipolar mode utilizes energy transfer between the distal electrode at the target ablation site and a reference electrode on the body surface. Multipolar mode utilizes energy transfer between the distal electrode and the ring electrode of the electrode segment. In actual atrial fibrillation surgery, in multipolar mode, when the distal electrode is positioned at the intended ablation site, the ring electrode typically floats in the blood, but there is a certain probability that it may adhere to a non-intended ablation site. When a pulsed voltage is applied, a high-intensity electric field is generated at both the distal electrode and the ring electrode, potentially leading to ablation of the non-intended ablation site adjacent to the ring electrode, resulting in complications.

[0005] Besides catheter electrode segments using polymer-coated ring electrodes, electrode segments composed of flexible circuit boards as electrode carriers are also used in catheter structure design for atrial fibrillation treatment. However, due to limitations in manufacturing technology, flexible circuit boards have poor torsional and bending resistance. When used as electrode segment carriers, the morphological changes of flexible circuit boards are somewhat restricted, especially when the electrode segment becomes petal-shaped. The bending at the junction of the electrode segment and the head electrode creates a small radius of curvature, leading to stress concentration and a decrease in the bending fatigue performance of the flexible circuit. Summary of the Invention

[0006] The purpose of this invention is to provide an electrode carrier, an electrophysiological catheter, and a high-voltage pulse ablation system to at least solve one of the technical problems existing in the prior art or related technologies.

[0007] To achieve the above objectives, in a first aspect, the present invention provides an electrophysiological catheter, comprising a catheter shaft and an electrode segment, wherein the electrode segment is disposed at the distal end of the catheter shaft;

[0008] The electrode segment includes an end electrode and an electrode assembly, the electrode assembly being closer to the proximal end of the catheter axis relative to the end electrode;

[0009] The electrode assembly includes at least one electrode carrier and a plurality of electrodes located on the electrode carrier. When the end electrode ablates the target tissue, the end electrode is paired with at least one of the electrodes to discharge.

[0010] The electrode carriers on which at least one of the electrodes participating in the paired discharge is located are different from the electrode carriers electrically connected to the end electrode.

[0011] Optionally, the electrode assembly includes a plurality of inner electrodes located on the side of the electrode carrier near the conduit axis, and the inner electrodes include at least one of the electrodes participating in the paired discharge.

[0012] Optionally, the inner electrode has a position facing the distal end of the conduit axis.

[0013] Optionally, the electrode carriers on which at least one of the electrodes participating in the paired discharge is located are electrically connected to the end electrode and are alternately arranged in the circumferential direction of the conduit shaft.

[0014] Optionally, the inner electrode has at least a first position and a second position;

[0015] In the first position, the electrode carrier where the inner electrode is located is in a contracted state, and the electrode carrier is drawn towards the duct axis.

[0016] In the second position, the electrode carrier is in an expanded state, and at least a portion of the electrode carrier moves from a position that converges toward the catheter axis to a position that moves away from the catheter axis, with the inner electrode facing the distal end of the catheter axis.

[0017] Optionally, the electrode assembly further includes a plurality of outer electrodes located on the side of the electrode carrier away from the conduit axis, and the outer electrodes being closer to the end electrode than the inner electrodes.

[0018] Optionally, the inner electrode has at least a third position, in which the electrode carrier on which the inner electrode is located is in an expanded state, and at least a portion of the inner electrode and at least a portion of the outer electrode act on the target tissue and ablate it.

[0019] Optionally, the electrode carrier of the electrode assembly includes a proximal end and a distal end, which are capable of relative movement to allow the electrode carrier of the electrode assembly to switch between a contracted state and an expanded state.

[0020] Optionally, the electrophysiological catheter further includes at least one stress diffuser disposed on at least one of the proximal end and the distal end of the carrier. In the expanded state, the stress diffuser is capable of dispersing the stress acting on at least one of the proximal end and the distal end of the carrier.

[0021] Optionally, the stress diffuser is fitted onto at least one of the proximal end and the distal end of the carrier, and in the expanded state, at least a portion of the stress diffuser deforms under the action of the at least one of the proximal end and the distal end of the carrier.

[0022] Optionally, the electrophysiological catheter further includes a shaping element disposed within the electrode assembly. The shaping element is sleeved on the catheter shaft. In the contracted state, the shaping element acts on at least one of the proximal end and the distal end of the carrier, causing the at least one of the proximal end and the distal end of the carrier to protrude outward away from the catheter shaft.

[0023] Optionally, the conduit shaft includes an inner shaft and an outer tube, the inner shaft and the outer tube being movable relative to each other, the proximal end of the carrier being disposed on the outer tube, and the distal end of the carrier being disposed on the inner shaft;

[0024] The shaping component is disposed on the inner shaft near the far end of the carrier.

[0025] Optionally, the shaping component is a variable diameter structure to enable the electrode carrier to form a predetermined working shape.

[0026] Optionally, the radial dimension of at least one of the distal end and proximal end of the shaping member is not greater than the inner diameter of the circle containing the end of the electrode carrier.

[0027] Optionally, the length of the shaping component is between 1mm and 5mm.

[0028] Optionally, the distance between the shaping component and the gathering component disposed on the guide shaft for gathering the distal end of the carrier is no greater than 5 mm.

[0029] Optionally, at least one electrode carrier of the electrode assembly includes a transmission line and a blind line, the transmission line being electrically connected to the electrode of the electrode assembly, and the blind line being electrically connected to the power supply unit but not forming an electrical circuit.

[0030] When the electrode assembly is working normally, the blind circuit and the transmission line do not conduct electricity; when the electrode carrier is cracked, the blind circuit and the transmission line conduct electricity and form an electrical circuit with the power supply unit.

[0031] Optionally, the electrode carrier further includes an insulating layer and a substrate, the transmission line is disposed on the insulating layer, the substrate covers the transmission line, and the electrode is disposed on the other side of the substrate relative to the transmission line and is electrically connected to the transmission line.

[0032] Optionally, the blind line extends along the extension direction of the electrode carrier from at least the proximal end of the electrode carrier to the point of maximum curvature of the distal end of the electrode carrier in the expanded state.

[0033] Optionally, the blind line is positioned closer to the outer side of the electrode carrier than the transmission line.

[0034] Optionally, there may be multiple electrode carriers electrically connected to the end electrodes.

[0035] Optionally, a superelastic shape memory alloy is disposed in at least one electrode carrier of the electrode assembly to improve its shape retention capability.

[0036] Secondly, the present invention provides a high-voltage pulse ablation system, including a power supply unit, a main control module, an electrode combination switch, a user interface, and an electrophysiological catheter as described above;

[0037] The main control module is used to send work instructions;

[0038] The power supply unit is communicatively connected to the main control module and is used to deliver high-voltage pulses to the electrode segments of the electrophysiological catheter according to the working instructions.

[0039] The electrode combination switch is communicatively connected to the main control module and is used to select the transmission line of the electrode carrier of the electrode assembly that needs to transmit energy according to the working instruction so as to realize the paired discharge of the electrode segments.

[0040] The user interface is communicatively connected to the main control module and is used for human-computer interaction to control and display information about the high-voltage pulse ablation system.

[0041] Optionally, the high-voltage pulse ablation system includes at least one of the following operating modes:

[0042] In the first working mode, ablation is performed through the end electrode;

[0043] In the second working mode, the electrode segment is in an expanded state, and ablation is performed through the end electrode and / or the outer electrode of the electrode assembly;

[0044] In the third working mode, the electrode segment is in an expanded state, and ablation is performed through the inner electrode and the outer electrode of the electrode assembly.

[0045] Optionally, the main control module can selectively control the end electrode, the outer electrode, and the inner electrode.

[0046] Thirdly, the present invention provides a high-voltage pulse ablation system, including a power supply unit, a main control module, an electrode combination switch, a user interface, and an electrophysiological catheter as described above;

[0047] The main control module is used to send work instructions;

[0048] The power supply unit is communicatively connected to the main control module and is used to deliver high-voltage pulses to the electrode segments of the electrophysiological catheter according to the working instructions.

[0049] The electrode combination switch is communicatively connected to the main control module and is used to select the transmission line that needs to deliver energy according to the working instruction in order to realize the paired discharge of the electrode segments.

[0050] The user interface is communicatively connected to the main control module and is used for human-computer interaction to control the high-voltage pulse ablation system and display information.

[0051] The power supply unit is also used to energize the blind line and the transmission line that needs to be discharged, so that the polarity of the blind line is opposite to that of at least one of the transmission lines.

[0052] The ablation system also includes a crack detection module that is communicatively connected to the main control module. The crack detection module is used to detect whether there is continuity between the blind line and the transmission line. If there is continuity, a crack signal is sent to the main control module.

[0053] Optionally, the power supply unit delivers a high-voltage pulse to the blind line.

[0054] Optionally, the power supply unit further includes a low-voltage generator. In the non-discharge state, the electrode combination switch can be switched to be connected to the low-voltage generator. The two poles of the low-voltage generator are electrically connected to the blind line and at least one of the transmission lines, respectively.

[0055] Fourthly, the present invention provides a catheter for treating target tissue, comprising a catheter shaft and a basket structure, the basket structure being disposed at the distal end of the catheter shaft and having a contracted state and an expanded state. In the contracted state, the basket structure retracts toward the catheter shaft to ensure that the catheter can safely reach the area where the target tissue is located; in the expanded state, at least a portion of the basket structure moves from a position retracting toward the catheter shaft to a position away from the catheter shaft.

[0056] The basket structure includes a proximal end and a distal end, which are capable of relative movement to allow the basket structure to switch between the contracted state and the expanded state.

[0057] At least one stress diffuser is disposed on at least one of the proximal end and the distal end of the basket, wherein, in the expanded state, the stress diffuser is capable of dispersing the stress acting on at least one of the proximal end and the distal end of the basket.

[0058] Optionally, the stress diffuser is fitted onto at least one of the proximal end and the distal end of the basket, and in the expanded state, at least a portion of the stress diffuser deforms under the action of the at least one of the proximal end and the distal end of the basket.

[0059] Optionally, the catheter further includes a shaping member disposed within the basket structure. The shaping member is sleeved on the catheter shaft. In the contracted state, the shaping member acts on at least one of the proximal end and the distal end of the basket, causing the at least one of the proximal end and the distal end of the basket to protrude outward away from the catheter shaft.

[0060] Optionally, the guide shaft includes an inner shaft and an outer tube, the inner shaft and the outer tube being movable relative to each other, the proximal end of the basket being disposed on the outer tube, and the distal end of the basket being disposed on the inner shaft; the shaping member is disposed on the inner shaft adjacent to the distal end of the basket.

[0061] Optionally, the shaping component is a variable diameter structure to enable the electrode carrier to form a predetermined working shape.

[0062] Optionally, the radial dimension of at least one of the distal end and proximal end of the shaping member is not greater than the inner diameter of the circle containing the end of the electrode carrier.

[0063] Optionally, the length of the shaping component is between 1mm and 5mm.

[0064] Optionally, the distance between the shaping component and the gathering component disposed on the guide shaft for gathering the far end of the basket is no more than 5mm.

[0065] Optionally, the basket structure includes a superelastic shape memory alloy to improve the shape retention capability of the basket structure.

[0066] Fifthly, the present invention provides a catheter for treating target tissue, comprising a catheter shaft and a basket structure, the basket structure being disposed at the distal segment of the catheter shaft and having a contracted state and an expanded state. In the contracted state, the basket structure retracts toward the catheter shaft to ensure that the catheter can safely reach the area where the target tissue is located; in the expanded state, at least a portion of the basket structure moves from a position retracting toward the catheter shaft to a position away from the catheter shaft.

[0067] The basket structure includes a proximal end and a distal end, which are capable of relative movement to allow the basket structure to switch between the contracted state and the expanded state.

[0068] The catheter also includes a shaping member disposed within the basket structure. The shaping member is sleeved on the catheter shaft. In the contracted state, the shaping member acts on at least one of the proximal end and the distal end of the basket, causing the at least one of the proximal end and the distal end of the basket to protrude outward away from the catheter shaft.

[0069] Optionally, the conduit shaft includes an inner shaft and an outer tube, the inner shaft and the outer tube being movable relative to each other, the proximal end of the basket being disposed on the outer tube, and the distal end of the basket being disposed on the inner tube;

[0070] The shaping component is disposed on the inner tube near the far end of the basket.

[0071] Optionally, the shaping component is a variable diameter structure to enable the electrode carrier to form a predetermined working shape.

[0072] Optionally, the radial dimension of at least one of the distal end and proximal end of the shaping member is not greater than the inner diameter of the circle containing the end of the electrode carrier.

[0073] Optionally, the length of the shaping component is between 1mm and 5mm.

[0074] Optionally, the distance between the shaping component and the gathering component disposed on the guide shaft for gathering the far end of the basket is no more than 5mm.

[0075] In a sixth aspect, the present invention provides an electrode carrier that can be disposed in the distal section of a conduit and includes a transmission line and a blind line, wherein the transmission line is electrically connected to the electrode and the blind line is electrically connected to the power supply unit and does not form an electrical circuit.

[0076] When the electrode carrier is working normally, the blind circuit and the transmission line do not conduct electricity; when the electrode carrier is cracked, the blind circuit and the transmission line conduct electricity and form an electrical circuit with the power supply unit.

[0077] Optionally, the electrode carrier further includes an insulating layer and a substrate, the transmission line is disposed on the insulating layer, the substrate covers the transmission line, and the electrode is disposed on the other side of the substrate relative to the transmission line and is electrically connected to the transmission line.

[0078] Optionally, the blind line extends along the extension direction of the electrode carrier from at least the proximal end of the electrode carrier to the point of maximum curvature of the distal end of the electrode carrier in the expanded state.

[0079] Optionally, the blind line is positioned closer to the outer side of the electrode carrier than the transmission line.

[0080] Optionally, a superelastic shape memory alloy is disposed in the electrode carrier to improve its shape retention capability.

[0081] In a seventh aspect, the present invention provides an electrophysiological catheter for ablation of target tissue, comprising a catheter shaft and an electrode assembly, wherein the electrode assembly is disposed at the distal segment of the catheter shaft;

[0082] The electrode assembly includes an electrode carrier as described above and the electrode located on the electrode carrier.

[0083] Optionally, the electrode includes an inner electrode and an outer electrode. The inner electrode is located on the side of the electrode carrier near the catheter axis, and the outer electrode is located on the side of the electrode carrier away from the catheter axis. The outer electrode is closer to the distal end of the catheter axis than the inner electrode.

[0084] Eighthly, the present invention provides a high-voltage pulse ablation system, including a power supply unit, a main control module, an electrode combination switch, a user interface, and an electrophysiological catheter as described above;

[0085] The main control module is used to send work instructions;

[0086] The power supply unit is communicatively connected to the main control module and is used to deliver high-voltage pulses to the electrode assembly according to the working instructions.

[0087] The electrode combination switch is communicatively connected to the main control module and is used to select the transmission line that needs to deliver energy according to the working instruction in order to realize the paired discharge of the electrode assembly.

[0088] The user interface is communicatively connected to the main control module and is used for human-computer interaction to control the high-voltage pulse ablation system and display information.

[0089] The power supply unit is also used to energize the blind line and the transmission line that needs to be discharged, so that the polarity of the blind line is opposite to that of at least one of the transmission lines.

[0090] The ablation system also includes a crack detection module that is communicatively connected to the main control module. The crack detection module is used to detect whether there is continuity between the blind line and the transmission line. If there is continuity, a crack signal is sent to the main control module.

[0091] Optionally, the power supply unit delivers a high-voltage pulse to the blind line.

[0092] Optionally, the power supply unit further includes a low-voltage generator. In the non-discharge state, the electrode combination switch can be switched to be connected to the low-voltage generator. The two poles of the low-voltage generator are electrically connected to the blind line and at least one of the transmission lines, respectively.

[0093] The electrode carrier, electrophysiological catheter, and high-voltage pulse ablation system provided by this invention have at least one of the following beneficial effects:

[0094] 1) By positioning at least one of the electrodes participating in the paired discharge on the side of the electrode carrier near the catheter axis, when the target tissue is ablated using the end electrode, the paired electrodes can be positioned away from the non-target tissue or at least make it difficult to contact the non-target tissue, thereby preventing the paired electrodes from acting on the non-target tissue to form an unintended ablation focus.

[0095] 2) By providing the stress diffuser on at least one of the proximal end and the distal end of the carrier, in the expanded state, the stress diffuser can disperse the stress acting on at least one of the proximal end and the distal end of the carrier, increase the bending radius of the electrode carrier corresponding to the location of the stress diffuser, prevent stress concentration, and thus avoid cracking of the electrode carrier.

[0096] 3) By providing a shaping element within the electrode assembly, the shaping element is sleeved on the catheter shaft. In the contracted state, the shaping element acts on at least one of the proximal and distal ends of the carrier, causing the at least one of the proximal and distal ends of the carrier to protrude outward away from the catheter shaft. Furthermore, when the electrode assembly acts on a tortuous blood vessel, by sleeved on the catheter shaft adjacent to the distal and / or proximal ends of the carrier, it is ensured that the electrode carrier can still bend away from the catheter shaft, avoiding bending towards the catheter shaft (i.e., folding back), thus preventing the electrode assembly from forming the predetermined working shape (such as a basket shape or petal shape).

[0097] 4) By setting the shaping component, the maximum distance of relative movement between the inner shaft and the outer tube of the guide tube shaft can also be controlled, thereby controlling the final shape of the expansion of the electrode assembly;

[0098] 5) By adding a blind circuit to the electrode carrier, under normal conditions, when the blind circuit is energized, since the blind circuit is electrically insulated from the transmission line, no electrical circuit is formed; when the electrode carrier cracks, the blind circuit is exposed to the external environment, and blood can act as a conductive medium, causing the insulation between the blind circuit and the transmission line that needs to transmit energy to fail, thereby forming an electrical circuit and generating current. This current can be detected by the crack detection module (such as a current sensor), and then it can be determined whether the electrode carrier is cracked. Attached Figure Description

[0099] 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:

[0100] Figure 1 This is a schematic diagram of an electrophysiological catheter in a contracted state according to an embodiment of the present invention;

[0101] Figure 2 This is a schematic diagram of an electrophysiological catheter in a basket state according to an embodiment of the present invention;

[0102] Figure 3 This is a schematic diagram of an electrophysiological catheter in a petal-like state according to an embodiment of the present invention;

[0103] Figure 4 This is an electrical schematic diagram of the end electrode ablation process according to an embodiment of the present invention;

[0104] Figure 5 This is a schematic diagram of a stress diffusion component provided in an embodiment of the present invention in its natural state;

[0105] Figure 6This is a schematic diagram of a stress diffusion component in operation according to an embodiment of the present invention;

[0106] Figure 7 This is a schematic diagram of a shaping component arranged at the far end of a carrier according to an embodiment of the present invention.

[0107] Figure 8 This is a schematic diagram of a variable-diameter shaping component arranged near the end of a carrier according to an embodiment of the present invention.

[0108] Figure 9 This is a schematic diagram of a variable diameter shaping component arranged at the far end of a carrier according to an embodiment of the present invention.

[0109] Figure 10 This is a schematic diagram illustrating the installation of a blind circuit according to an embodiment of the present invention;

[0110] Figure 11 This is a schematic diagram of the structure of an electrode carrier provided in an embodiment of the present invention;

[0111] Figure 12 This is a schematic diagram showing the connection between the end electrode and the electrode carrier according to an embodiment of the present invention;

[0112] Figure 13 This is a schematic diagram of the structure of an insulating layer provided in an embodiment of the present invention;

[0113] Figure 14 This is a schematic diagram of a high-voltage pulse ablation system provided in an embodiment of the present invention;

[0114] Figure 15 This is a schematic diagram of another high-voltage pulse ablation system provided in an embodiment of the present invention.

[0115] In the attached image:

[0116] 1-Conduit shaft; 2-End electrode; 3-Electrode assembly; 4-Stress diffusion component; 5-Shaping component; 6-Basket structure; 7-Collapsing component;

[0117] 10-Inner shaft; 11-Outer tube; 20-End electrode pad; 30-Electrode carrier; 31-Electrode; 32-Transmission line; 33-Blind line; 34-Insulating layer; 36-Superelastic shape memory alloy;

[0118] 310 - Inner electrode; 311 - Outer electrode; 312 - Electrode pad; 321 - First transmission line; 322 - Second transmission line; 323 - Third transmission line; 341 - First insulating layer; 342 - Second insulating layer; 351 - First substrate; 352 - Second substrate;

[0119] 1001-Power supply unit; 1002-Main control module; 1003-Electrode combination switch; 1004-User interface; 1005-Electrophysiological catheter; 1006-Crack detection module. Detailed Implementation

[0120] The core idea of ​​this invention is to provide an electrode carrier, an electrophysiological catheter, and a high-voltage pulse ablation system to solve the problems of electrode contact with non-predetermined ablation sites and electrode carrier cracking caused by stress concentration when using ring electrodes for high-voltage pulse ablation in the prior art.

[0121] In a first aspect, the present invention provides an electrophysiological catheter, comprising a catheter shaft and an electrode segment, wherein the electrode segment is disposed at the distal end of the catheter shaft;

[0122] The electrode segment includes an end electrode and an electrode assembly, the electrode assembly being closer to the proximal end of the catheter axis relative to the end electrode;

[0123] The electrode assembly includes at least one electrode carrier and a plurality of electrodes located on the electrode carrier. When the end electrode ablates the target tissue, the end electrode is paired with at least one of the electrodes to discharge. At least one of the electrodes participating in the paired discharge is located on the side of the electrode carrier near the catheter axis.

[0124] Secondly, the present invention provides a high-voltage pulse ablation system, including a power supply unit, a main control module, an electrode combination switch, a user interface, and an electrophysiological catheter as described above;

[0125] The main control module is used to send work instructions;

[0126] The power supply unit is communicatively connected to the main control module and is used to deliver high-voltage pulses to the electrode segments of the electrophysiological catheter according to the working instructions.

[0127] The electrode combination switch is communicatively connected to the main control module and is used to select the transmission line of the electrode carrier of the electrode assembly that needs to transmit energy according to the working instruction so as to realize the paired discharge of the electrode segments.

[0128] The user interface is communicatively connected to the main control module and is used for human-computer interaction to control and display information about the high-voltage pulse ablation system.

[0129] Thirdly, the present invention provides a high-voltage pulse ablation system, including a power supply unit, a main control module, an electrode combination switch, a user interface, and an electrophysiological catheter as described above;

[0130] The main control module is used to send work instructions;

[0131] The power supply unit is communicatively connected to the main control module and is used to deliver high-voltage pulses to the electrode segments of the electrophysiological catheter according to the working instructions.

[0132] The electrode combination switch is communicatively connected to the main control module and is used to select the transmission line that needs to deliver energy according to the working instruction in order to realize the paired discharge of the electrode segments.

[0133] The user interface is communicatively connected to the main control module and is used for human-computer interaction to control the high-voltage pulse ablation system and display information.

[0134] The power supply unit is also used to energize the blind line and the transmission line that needs to be discharged, so that the polarity of the blind line is opposite to that of at least one of the transmission lines.

[0135] The ablation system also includes a crack detection module that is communicatively connected to the main control module. The crack detection module is used to detect whether there is continuity between the blind line and the transmission line. If there is continuity, a crack signal is sent to the main control module.

[0136] Fourthly, the present invention provides a catheter for treating target tissue, comprising a catheter shaft and a basket structure, the basket structure being disposed at the distal end of the catheter shaft and having a contracted state and an expanded state. In the contracted state, the basket structure retracts toward the catheter shaft to ensure that the catheter can safely reach the area where the target tissue is located; in the expanded state, at least a portion of the basket structure moves from a position retracting toward the catheter shaft to a position away from the catheter shaft.

[0137] The basket structure includes a proximal end and a distal end, which are capable of relative movement to allow the basket structure to switch between the contracted state and the expanded state.

[0138] At least one stress diffuser is disposed on at least one of the proximal end and the distal end of the basket, wherein, in the expanded state, the stress diffuser is capable of dispersing the stress acting on at least one of the proximal end and the distal end of the basket.

[0139] Fifthly, the present invention provides a catheter for treating target tissue, comprising a catheter shaft and a basket structure, the basket structure being disposed at the distal segment of the catheter shaft and having a contracted state and an expanded state. In the contracted state, the basket structure retracts toward the catheter shaft to ensure that the catheter can safely reach the area where the target tissue is located; in the expanded state, at least a portion of the basket structure moves from a position retracting toward the catheter shaft to a position away from the catheter shaft.

[0140] The basket structure includes a proximal end and a distal end, which are capable of relative movement to allow the basket structure to switch between the contracted state and the expanded state.

[0141] The catheter also includes a shaping member disposed within the basket structure. The shaping member is sleeved on the catheter shaft. In the contracted state, the shaping member acts on at least one of the proximal end and the distal end of the basket, causing the at least one of the proximal end and the distal end of the basket to protrude outward away from the catheter shaft.

[0142] In a sixth aspect, the present invention provides an electrode carrier that can be disposed in the distal section of a conduit and includes a transmission line and a blind line, wherein the transmission line is electrically connected to the electrode and the blind line is electrically connected to the power supply unit and does not form an electrical circuit.

[0143] When the electrode carrier is working normally, the blind circuit and the transmission line do not conduct electricity; when the electrode carrier is cracked, the blind circuit and the transmission line conduct electricity and form an electrical circuit with the power supply unit.

[0144] In a seventh aspect, the present invention provides an electrophysiological catheter for ablation of target tissue, comprising a catheter shaft and an electrode assembly, wherein the electrode assembly is disposed at the distal segment of the catheter shaft;

[0145] The electrode assembly includes an electrode carrier as described above and the electrode located on the electrode carrier.

[0146] Eighthly, the present invention provides a high-voltage pulse ablation system, including a power supply unit, a main control module, an electrode combination switch, a user interface, and an electrophysiological catheter as described above;

[0147] The main control module is used to send work instructions;

[0148] The power supply unit is communicatively connected to the main control module and is used to deliver high-voltage pulses to the electrode assembly according to the working instructions.

[0149] The electrode combination switch is communicatively connected to the main control module and is used to select the transmission line that needs to deliver energy according to the working instruction in order to realize the paired discharge of the electrode assembly.

[0150] The user interface is communicatively connected to the main control module and is used for human-computer interaction to control the high-voltage pulse ablation system and display information.

[0151] The power supply unit is also used to energize the blind line and the transmission line that needs to be discharged, so that the polarity of the blind line is opposite to that of at least one of the transmission lines.

[0152] The ablation system also includes a crack detection module that is communicatively connected to the main control module. The crack detection module is used to detect whether there is continuity between the blind line and the transmission line. If there is continuity, a crack signal is sent to the main control module.

[0153] This configuration, by positioning at least one of the electrodes participating in the paired discharge on the side of the electrode carrier near the catheter axis, ensures that when the target tissue is ablated using the end electrode, the paired electrodes face away from or are at least unlikely to contact the non-target tissue, thereby preventing the paired electrodes from forming unintended ablation foci on the non-target tissue. Furthermore, by providing the stress diffuser on at least one of the proximal and distal ends of the carrier, in the expanded state, the stress diffuser can disperse the stress acting on at least one of the proximal and distal ends of the carrier, increasing the bending radius of the electrode carrier corresponding to the location of the stress diffuser, preventing stress concentration, and thus avoiding cracking of the electrode carrier.

[0154] 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.

[0155] 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.

[0156] 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.

[0157] Please refer to Figures 1-3 In a first aspect, embodiments of the present invention provide an electrophysiological catheter 1005 for ablation of target tissue, comprising a catheter shaft 1 and an electrode segment, wherein the electrode segment is disposed at the distal end of the catheter shaft 1;

[0158] The electrode segment includes an end electrode 2 and an electrode assembly 3, wherein the electrode assembly 3 is closer to the proximal end of the catheter shaft 1 relative to the end electrode 2;

[0159] The electrode assembly 3 includes at least one electrode carrier 30 and a plurality of electrodes 31 located on the electrode carrier 30. When the end electrode 2 ablates the target tissue, the end electrode 2 is paired with at least one of the electrodes 31 for discharge. At least one of the electrodes 31 participating in the paired discharge is located on the side of the electrode carrier 30 near the catheter shaft 1.

[0160] When the end electrode 2 is used to ablate the target tissue, by positioning at least one of the electrodes 31 participating in the paired discharge on the side of the electrode carrier 30 near the catheter shaft 1, the paired electrodes 31 can face away from or at least have difficulty contacting the non-target tissue, thereby preventing the paired electrodes 31 from acting on the non-target tissue to form an unintended ablation foci. Preferably, all the electrodes 31 participating in the paired discharge are located on the side of the electrode carrier 30 near the catheter shaft 1.

[0161] 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.

[0162] In this embodiment, the electrode carrier 30 of the electrode assembly 3 includes a proximal end and a distal end, which are capable of relative movement to allow the electrode carrier 30 of the electrode assembly 3 to switch between a contracted state and an expanded state. Figure 1 As shown, in the contracted state, the electrode carrier 30 retracts towards the catheter axis 1 to ensure that the catheter can safely reach the target tissue area; in the expanded state, at least a portion of the electrode carrier 30 moves from a position retracted towards the catheter axis 1 to a position away from the catheter axis 1. When switching from the contracted state to the expanded state, the position of the electrode 31 on the electrode carrier 30 also changes accordingly. In this embodiment, it will be referred to as a basket (e.g.) Figure 2 (as shown) and petal state (as shown) Figure 3 The technical concept of the present invention is further illustrated by taking these two typical expansion states as examples.

[0163] In this embodiment, the conduit shaft 1 includes an inner shaft 10 and an outer tube 11. The proximal end of the carrier is disposed on the outer tube 11, and the distal end of the carrier is disposed on the inner shaft 10. The inner shaft 10 and the outer tube 11 can move relative to each other so that the electrode carrier 30 of the electrode assembly 3 can switch between a contracted state and an expanded state.

[0164] Preferably, the outer tube 11 is sleeved on the inner shaft 10. Preferably, the inner shaft 10 and the outer shaft can be woven from materials such as polyurethane, Pebax (polyether block polyamide), and polyimide.

[0165] Preferably, the electrode carrier 30 on which at least one of the electrodes 31 participating in the paired discharge is located is a different electrode carrier 30 from the electrode carrier 30 electrically connected to the end electrode 2. Since the electrodes 31 participating in the paired discharge need to transmit high-voltage pulses through transmission lines, to reduce the insulation design requirements of the electrode carrier 30 and prevent high-voltage insulation breakdown between the transmission lines of the electrode 31 on the electrode carrier 30 on which the end electrode 2 is located and the transmission lines of the end electrode 2, the end electrodes 2 and 31 located on different electrode carriers 30 can be paired for discharge.

[0166] Preferably, multiple electrode carriers 30 are electrically connected to the end electrode 2 to disperse the current and reduce the linewidth of the electrode carrier 30 carrying the current of the end electrode 2. For cardiac ablation therapy, to achieve an ablation depth of 3-10 mm, at a voltage of 500 V to 2000 V, the corresponding linewidth of the end electrode 2 is between 0.05 mm and 0.3 mm. Generally, when considering the linewidth, the line thickness should be taken into account, and the line thickness is generally 20 μm copper.

[0167] More preferably, the electrode carrier 30 containing at least one of the electrodes 31 participating in the paired discharge and the electrode carrier 30 electrically connected to the end electrode 2 are alternately arranged in the circumferential direction of the conduit shaft 1, so as to design as many electrode carriers 30 electrically connected to the end electrode 2 as possible, thereby improving the ablation effect. For example, such as Figure 4 As shown, viewed from the axial direction of the conduit shaft 1, the electrode carriers 30 are numbered in a clockwise direction. The electrode carriers 30 that are electrically connected to the end electrode 2 are numbered with odd numbers, while the electrode carriers 30 where the electrode 31 that is paired with the end electrode 2 for discharge are located are numbered with even numbers. Figure 4 The "+" and "-" in the text represent different polarities.

[0168] Furthermore, the electrode assembly 3 includes a plurality of inner electrodes 310, which are located on the side of the electrode carrier 30 near the conduit shaft 1, and the inner electrodes 310 include at least one of the electrodes 31 participating in the paired discharge.

[0169] Furthermore, the inner electrode 310 is positioned toward the distal end of the conduit shaft 1.

[0170] In this embodiment, the inner electrode 310 has at least a first position and a second position;

[0171] In the first position, the electrode carrier 30 where the inner electrode 310 is located is in a contracted state, and the electrode carrier 30 retracts toward the conduit shaft 1.

[0172] In the second position, the electrode carrier 30 is in an expanded state (e.g., Figure 2 (as shown in the basket configuration), at least a portion of the electrode carrier 30 moves from a position retracted toward the conduit shaft 1 to a position away from the conduit shaft 1, with the inner electrode 310 facing the distal end of the conduit shaft 1.

[0173] It can be seen that when the end electrode 2 is paired with at least one of the inner electrodes 310 to ablate the target tissue, the inner electrode 310 will not act on non-target tissue to form an unexpected ablation foci.

[0174] Furthermore, the electrode assembly 3 also includes a plurality of outer electrodes 311, which are located on the side of the electrode carrier 30 opposite to the conduit axis 1. The outer electrodes 311 are closer to the end electrode 2 than the inner electrodes 310. That is, the inner electrodes 310 and the outer electrodes 311 are located on two opposite sides of the electrode carrier 30, and the electrode 31 is divided into the inner electrodes 310 and the outer electrodes 311 by being closer to or further away from the conduit axis 1.

[0175] Furthermore, the inner electrode 310 has at least a third position, in which the electrode carrier 30 on which the inner electrode 310 is located is in an expanded state (e.g., Figure 3 (as shown in the petal state), at least one of the inner electrodes 310 is capable of pairing and discharging with at least one of the outer electrodes 311, and at least a portion of the inner electrodes 310 participating in the paired discharge and at least a portion of the outer electrodes 311 act on the target tissue and ablate it.

[0176] Preferably, the electrode carrier 30 is made of a flexible material, and the electrode 31 can be made of materials such as platinum, gold, or platinum-iridium alloy. Preferably, the electrode 31 is a sheet electrode.

[0177] Please refer to Figures 5-6 The electrophysiological catheter 1005 further includes at least one stress diffuser 4, which is disposed on at least one of the proximal end and the distal end of the carrier. In the expanded state, the stress diffuser 4 can disperse the stress acting on at least one of the proximal end and the distal end of the carrier, increase the bending radius of the electrode carrier 30 corresponding to the location of the stress diffuser 4, prevent stress concentration, and thus avoid cracking of the electrode carrier 30.

[0178] Furthermore, the stress diffuser 4 is sleeved on at least one of the proximal end and the distal end of the carrier. In the expanded state, at least a portion of the stress diffuser 4 deforms under the action of the at least one of the proximal end and the distal end of the carrier. In this embodiment, the stress diffuser 4 has an initial form and an active form. In the initial form, such as... Figure 5 The stress diffuser 4 remains in its natural state; in the operating mode, such as Figure 6 At least a portion of the stress diffuser 4 deforms under the action of the end section, dispersing the stress acting on at least one of the proximal end and the distal end of the carrier. For example, the stress diffuser 4 is provided at the distal end of the carrier, and when the electrode carrier 30 switches from a contracted state to an expanded state, the stress diffuser 4 replaces the end electrode 2 in acting on the distal end of the carrier, allowing the portion of the electrode carrier 30 adjacent to the distal end of the carrier to move away from the conduit shaft 1.

[0179] Preferably, at least a portion of the stress diffuser 4 has greater flexibility than the end electrode 2.

[0180] Preferably, the stress diffuser 4 is an annular member, fitted onto at least one of the proximal end and the distal end of the carrier, with a diameter equivalent to that of the end electrode 2 to ensure normal sheath passage. The length of the stress diffuser 4 is generally between 0.5 mm and 5 mm, and the thickness is between 0.1 mm and 0.5 mm, and it can be made of elastic materials such as Pebax or polyurethane. Preferably, the free end of the stress diffuser 4 is made of elastic material and can be fixed by adhesive bonding.

[0181] Please refer to Figure 7 The electrophysiological catheter 1005 further includes a shaping member 5 disposed within the electrode assembly 3. The shaping member 5 is sleeved on the catheter shaft 1. In the contracted state, the shaping member 5 acts on at least one of the proximal end and the distal end of the carrier, causing the at least one of the proximal end and the distal end of the carrier to bulge outward away from the catheter shaft 1.

[0182] When the electrode assembly 3 is applied to a curved blood vessel, by fitting the shaping element 5 onto the catheter shaft 1 adjacent to the distal end and / or proximal end of the carrier, it is ensured that the electrode carrier 30 can still bend away from the catheter shaft 1, avoiding bending towards the catheter shaft 1 (i.e., folding back), which would prevent the electrode assembly 3 from forming the predetermined working shape (such as a basket shape or petal shape). Furthermore, the shaping element 5 ensures that the electrode carrier 30, even with a sheet-like flexible structure, can form the predetermined working shape at the site of the curved blood vessel.

[0183] When the shaping member 5 is disposed near the distal end of the carrier, the shaping member 5 can be disposed on the inner shaft 10 of the conduit shaft 1; when the shaping member 5 is disposed near the proximal end of the carrier, the shaping member 5 can be disposed on the outer tube 11 of the conduit shaft 1, or alternatively, can be movably disposed on the inner shaft 10 relative to the inner shaft 10. Preferably, in this embodiment, as... Figure 7 The shaping component 5 is disposed on the inner shaft 10 adjacent to the far end of the carrier.

[0184] Preferably, the maximum outer diameter of the shaping component 5 is greater than the outer diameter of the circle containing the distal end of the carrier, so that when the electrode assembly 3 is in a contracted state, the distal end of the carrier can bulge outward, tending to move away from the guide shaft 1, thus playing a pre-shaping role. When the shaping component 5 is positioned close to the proximal end of the carrier, the maximum outer diameter of the shaping component 5 is greater than the outer diameter of the circle containing the proximal end of the carrier. More preferably, the maximum outer diameter of the shaping component 5 is less than the maximum outer diameter of the outer tube 11 and the maximum outer diameter of the gathering component 7 at the distal end of the carrier. Preferably, the gathering component 7 is the end electrode 2, the stress diffusion component 4, or other components that gather the distal end of the carrier. It should be understood that, in this application, the gathering component 7 is... Figures 1-3 , Figures 5-8 The figure may be in the form of the end electrode 2.

[0185] Furthermore, the radial dimension of at least one of the distal and proximal ends of the shaping member 5 is not greater than the inner diameter of the circle containing the end of the electrode carrier 30. This is to prevent the end of the shaping member 5 from compressing the end of the electrode carrier 30 when the electrode carrier 30 switches from a contracted state to an expanded state, thus preventing stress concentration and subsequent bending and cracking of the electrode carrier 30. For example, when the shaping member 5 is disposed on the inner shaft 10 near the distal end of the carrier, the outer diameter of the proximal end of the shaping member 5 is smaller than the inner diameter of the circle containing the proximal end of the carrier. In this way, when the electrode carrier 30 switches from a contracted state to an expanded state, the proximal end of the shaping member 5 will not compress the proximal end of the carrier, reducing the possibility of bending and cracking.

[0186] More preferably, at least a portion of the shaping member 5 has a distal outer diameter near the end electrode 2 that is smaller than the proximal outer diameter of the shaping member 5 away from the end electrode 2, in combination with Figure 8 The shaping component 5 has a variable diameter structure to better enable the electrode carrier 30 to form a predetermined working shape.

[0187] Preferably, the conduit shaft 1 includes an inner shaft 10 and an outer tube 11, the inner shaft 10 and the outer tube 11 are capable of relative movement, the proximal end of the carrier is disposed on the outer tube 11, the distal end of the carrier is disposed on the inner shaft 10, and the shaping member 5 is disposed on the inner shaft 10 adjacent to the distal end of the carrier. The shaping member 5 can control the maximum distance of relative movement between the inner shaft 10 and the outer tube 11 of the conduit shaft 1, thereby controlling the final shape of the expansion of the electrode assembly 3.

[0188] Furthermore, when the shaping component 5 is disposed at the proximal end of the carrier, the proximal end of the carrier can be clamped and fixed by the shaping component 5 and the outer tube 11.

[0189] In this embodiment, the shaping component 5 can be made of elastic materials such as Pebax (polyether block polyamide) or polyurethane. Preferably, the shaping component 5 is bonded and fixed to the inner shaft 10 or the outer tube 11.

[0190] Preferably, the distance between the shaping member 5 and the end electrode 2 is no greater than 5 mm. More preferably, the dimension of the shaping member 5 near the end electrode 2 is smaller than the outer diameter of the circle containing the distal end of the carrier, so as to reduce the movement of the shaping member 5.

[0191] Please refer to Figure 10 At least one electrode carrier 30 of the electrode assembly 3 includes a transmission line 32 and a blind line 33. The transmission line 32 is electrically connected to the electrode 31 of the electrode assembly 3, and the blind line 33 is electrically connected to the power supply unit and does not form an electrical circuit.

[0192] When the electrode assembly 3 is working normally, the blind line 33 and the transmission line 32 do not conduct electricity; when the electrode carrier 30 is cracked, the blind line 33 and the transmission line 32 conduct electricity and form an electrical circuit with the power supply unit.

[0193] Under normal conditions, when the blind circuit 33 is energized, it will not form an electrical circuit because it is electrically insulated from the transmission line 32. When the electrode carrier 30 cracks, the blind circuit 33 is exposed to the external environment. Blood can act as a conductive medium, causing the insulation between the blind circuit 33 and the transmission line 32 that needs to transmit energy to fail, thereby forming an electrical circuit and generating current. This current can be detected by the crack detection module (such as a current sensor) and thus determine whether the electrode carrier 30 is cracked.

[0194] Preferably, the blind line 33 and the transmission line 32 are layered structures, with layers arranged between each other.

[0195] Preferably, considering that the distal end of the electrode carrier 30 is more prone to cracking at the point of maximum bending in the expanded state, the blind line 33 extends at least from the proximal end of the electrode carrier 30 to the point of maximum bending at the distal end of the electrode carrier 30 in the expanded state along the extension direction of the electrode carrier 30.

[0196] Preferably, the blind line 33 is positioned closer to the outer side of the electrode carrier 30 than the transmission line 32, so as to detect cracks in the electrode carrier 30 in a timely manner and ensure the safety of treatment.

[0197] Optionally, the electrode segment may be provided with one blind line 33 or multiple blind lines 33 that are insulated from each other. This application does not limit this.

[0198] In this embodiment, the electrode carrier 30 further includes an insulating layer 34 and a substrate. The transmission line 32 is disposed on the insulating layer 34, and the substrate covers the transmission line 32. The electrode 31 is disposed on the other side of the substrate relative to the transmission line 32 and is electrically connected to the transmission line 32.

[0199] Preferably, an electrode pad 312 is provided on the other side of the substrate, and the electrode 31 is electrically connected to the transmission line 32 through the pad 312.

[0200] Please refer to Figure 11 In this embodiment, the transmission line 32 includes a first transmission line 321 electrically connected to the inner electrode 310 and a second transmission line 322 electrically connected to the outer electrode 311. Correspondingly, the substrate includes a first substrate 351 and a second substrate 352. The first transmission line 321 and the second transmission line 322 are respectively disposed on opposite sides of the insulating layer 34. The first substrate 351 and the second substrate 352 respectively cover the first transmission line 321 and the second transmission line 322. The insulating layer 34 is used to isolate the first transmission line 321 and the second transmission line 322.

[0201] Please continue to refer to Figure 11 The transmission line 32 further includes a third transmission line 323 connected to the end electrode 2, and the third transmission line 323 is electrically connected to the end electrode 2 through the end electrode pad 20 disposed on the substrate.

[0202] Please refer to Figure 12The end electrode pad 20 is electrically connected to the end electrode 2 via a wire. The end electrode 2 can be filled with glue to ensure the connection between the electrode carrier 30 and the end electrode 2. This provides a buffer space when the electrode carrier 30 switches to the expanded state, preventing the connection between the end electrode 2 and the electrode carrier 30 from accidentally becoming loose.

[0203] Optionally, the third transmission line 323 may be set in the first transmission line layer, the second transmission line layer, or a third transmission line layer may be set independently. This application does not limit this.

[0204] In this embodiment, the material of the insulating layer 34 includes, but is not limited to, polyimide, PDMS (polydimethylsiloxane), or LCP (industrial liquid crystal polymer).

[0205] For preferred options, please refer to [the provided text]. Figure 13 The insulating layer 34 is a composite insulating layer, which includes a first insulating layer 341 and a second insulating layer 342. A superelastic shape memory alloy 36, such as a nickel-titanium alloy, is disposed between the first insulating layer 341 and the second insulating layer 342 to improve the shape retention capability of the electrode carrier 30.

[0206] In this embodiment, insulating adhesive is filled between the insulating layer and the base layer for bonding between layers and for insulation of the transmission line.

[0207] Preferably, at least one electrode carrier 30 of the electrode assembly 3 is provided with a superelastic shape memory alloy 36 to improve its shape retention capability.

[0208] Please refer to Figure 14 and combined Figures 1-4 as well as Figure 11 The present invention provides a high-voltage pulse ablation system, including a power supply unit 1001, a main control module 1002, an electrode combination switch 1003, a user interface 1004, and an electrophysiological catheter 1005 as described above.

[0209] The main control module 1002 is used to send working instructions;

[0210] The power supply unit 1001 is communicatively connected to the main control module 1002 and is used to deliver high-voltage pulses to the electrode segments of the electrophysiological catheter 1005 according to the working instructions.

[0211] The electrode combination switch 1003 is communicatively connected to the main control module 1002 and is used to select the transmission line 32 of the electrode carrier 30 of the electrode assembly that needs to transmit energy according to the working instruction so as to realize the paired discharge of the electrode segments.

[0212] The user interface 1004 is communicatively connected to the main control module 1002 and is used for human-computer interaction to control the high-voltage pulse ablation system and display information.

[0213] Furthermore, the high-voltage pulse ablation system includes at least one of the following operating modes:

[0214] In the first working mode, ablation is performed through the end electrode 2;

[0215] In the second working mode, the electrode segment is in an expanded state and is ablated by the end electrode 2 and / or the outer electrode 311 of the electrode assembly 3;

[0216] In the third working mode, the electrode segment is in an expanded state and is ablated by the inner electrode 310 and / or the outer electrode 311 of the electrode assembly 3.

[0217] Among them, the most important working mode of the high-voltage pulse ablation system provided in this embodiment is the ablation through the end electrode 2 and the inner electrode 310 of the electrode assembly 3.

[0218] In this embodiment, in the first working mode, the electrode segment is in a contracted state and is ablated by the end electrode 2. In this state, the end electrode 2 and the inner electrode 310 of the electrode assembly 3 are paired and discharged.

[0219] In this embodiment, in the second working mode, the electrode segment is in a basket state and can be ablated by the end electrode 2 and / or the outer electrode 311 of the electrode assembly 3; when ablation is performed by the end electrode 2, the end electrode 2 and the inner electrode 310 of the electrode assembly 3 are paired and discharged; when ablation is performed by the outer electrode 311 of the electrode assembly 3, the outer electrode 311 and the inner electrode 310 are paired and discharged.

[0220] In this embodiment, in the third working mode, the electrode segment is in a petal state and is ablated by the inner electrode 310 and / or the outer electrode 311 of the electrode assembly 3. In this state, the outer electrode 311 and the inner electrode 310 perform paired discharge.

[0221] Preferably, the main control module 1002 can selectively control the end electrode 2, the outer electrode 311 and the inner electrode 310.

[0222] Furthermore, the power supply unit 1001 is also used to energize the blind line 33 and the transmission line 32 that needs to be discharged, so that the polarity of the blind line 33 is opposite to the polarity of at least one of the transmission lines 32.

[0223] Please refer to Figure 15 and combined Figure 10 The ablation system also includes a crack detection module 1006 that is communicatively connected to the main control module 1002. The crack detection module 1006 is used to detect whether there is continuity between the blind line 33 and the transmission line 32. If there is continuity, a crack signal is sent to the main control module 1002.

[0224] Under normal conditions, since the blind circuit 33 is electrically insulated from the external environment, it does not form an electrical circuit with the transmission line 32, and the crack detection module 1006 cannot detect the current generated between the normally discharging transmission line 32 and the blind circuit 33. When the electrode carrier 30 cracks, the blind circuit 33 is exposed to the external environment. Blood can act as a conductive medium, causing the insulation between the blind circuit 33 and the discharging transmission line 32 to fail, thereby forming an electrical circuit and generating current. The crack detection module 1006 can detect this current and send a crack signal to the main control module 1002. The main control module 1002 interrupts the discharge of the high-voltage pulse electric field generator to end the treatment based on the crack signal, or provides a warning (such as issuing an alarm) to improve system safety.

[0225] Preferably, the transmission line 32 for the discharge is a transmission line 32 adjacent to the blind line 33.

[0226] In this embodiment, the power supply unit 1001 includes a high-voltage pulse electric field generator, which can transmit high-voltage pulses to the blind line 33.

[0227] Preferably, the power supply unit 1001 further includes a low-voltage generator. In the non-discharge state, the electrode combination switch 1003 can switch to be connected to the low-voltage generator, replacing the high-voltage pulse electric field generator to energize the blind circuit 33. The two poles of the low-voltage generator are electrically connected to the blind circuit 33 and at least one of the transmission lines 32, respectively. Since the low-voltage generator continuously releases a low-voltage signal, the current can be detected in real time by the crack detection module 1006. By transmitting an electrical signal to the blind circuit 33 through the low-voltage generator, the insulation design of the electrode carrier 30 can be reduced, while ensuring treatment safety.

[0228] On the other hand, please combine Figure 2 , Figure 5 and Figure 6This invention provides a catheter for treating target tissue, comprising a catheter shaft 1 and a basket structure 6. The basket structure 6 is disposed at the distal end of the catheter shaft 1 and has a contracted state and an expanded state. In the contracted state, the basket structure 6 retracts towards the catheter shaft 1 to ensure that the catheter can safely reach the area where the target tissue is located. In the expanded state, at least a portion of the basket structure 6 moves from the position retracted towards the catheter shaft 1 to a position away from the catheter shaft 1.

[0229] The basket structure 6 includes a proximal end and a distal end, which are capable of relative movement to allow the basket structure 6 to switch between the contracted state and the expanded state.

[0230] At least one stress diffuser 4 is disposed on at least one of the proximal end and the distal end of the basket. In the expanded state, the stress diffuser 4 can disperse the stress acting on the at least one of the proximal end and the distal end of the basket, increase the bending radius of the basket structure 6 corresponding to the location of the stress diffuser 4, prevent stress concentration, thereby avoiding cracking of the basket structure 6 and preventing the proximal end and the distal end of the basket from failing to return to their contracted state under excessive stress.

[0231] In this embodiment, the basket structure 6 includes, but is not limited to, the electrode assembly 3 in the aforementioned embodiments. The catheter includes, but is not limited to, the electrophysiological catheter 1005 in the aforementioned embodiments. It should be understood that, in this application, the basket structure 6... Figures 1-3 It can exist in the form of the electrode assembly 3.

[0232] Furthermore, the stress diffuser 4 is sleeved on at least one of the proximal end and the distal end of the basket. In the expanded state, at least a portion of the stress diffuser 4 deforms under the action of the at least one of the proximal end and the distal end of the basket. In this embodiment, the stress diffuser 4 has an initial form and an active form. In the initial form, the stress diffuser 4 maintains its natural state; in the active form, at least a portion of the stress diffuser 4 deforms under the action of the end section, dispersing the stress acting on the at least one of the proximal end and the distal end of the basket.

[0233] Preferably, the stress diffuser 4 is a ring-shaped component, fitted onto at least one of the near end and far end of the basket. The stress diffuser 4 typically has a length between 0.5mm and 5mm and a thickness between 0.1mm and 0.5mm, and can be made of elastic materials such as Pebax or polyurethane. Preferably, the free end of the stress diffuser 4 is made of an elastic material and can be fixed using adhesive.

[0234] Furthermore, in combination Figure 7 The catheter further includes a shaping member 5 disposed within the basket structure 6. The shaping member 5 is sleeved on the catheter shaft 1. In the contracted state, the shaping member 5 acts on at least one of the proximal and distal ends of the basket, causing the proximal and distal ends of the basket to bulge outwards away from the catheter shaft 1. When the catheter is applied to a tortuous blood vessel, by sleeved on the catheter shaft 1 adjacent to the distal and / or proximal ends of the basket, it is ensured that the basket structure 6 can still bend away from the catheter shaft 1, preventing it from bending towards the catheter shaft 1 (i.e., folding back), thus preventing the basket structure 6 from forming its intended working shape. Furthermore, the shaping member 5 ensures that the basket structure 6, even with a sheet-like flexible structure, can form its intended working shape at the site of a tortuous blood vessel.

[0235] Furthermore, the conduit shaft 1 includes an inner shaft 10 and an outer tube 11, which are movable relative to each other. The proximal end of the basket is disposed on the outer tube 11, and the distal end of the basket is disposed on the inner shaft 10. When the shaping member 5 is disposed near the distal end of the basket, the shaping member 5 can be disposed on the inner shaft 10 of the conduit shaft 1; when the shaping member 5 is disposed near the proximal end of the basket, the shaping member 5 can be disposed on the outer tube 11 of the conduit shaft 1, or alternatively, it can be movably disposed on the inner shaft 10 relative to the inner shaft 10.

[0236] Preferably, the shaping member 5 is disposed on the inner shaft 10 near the far end of the basket. The shaping member 5 can control the maximum distance of relative movement between the inner shaft 10 and the outer tube 11 of the guide shaft 1, thereby controlling the final shape of the expansion of the basket structure 6.

[0237] Preferably, the maximum outer diameter of the shaping member 5 is greater than the outer diameter of the circle containing the distal end of the basket, so that when the basket structure 6 is in a contracted state, the distal end of the basket can bulge outward, tending to move away from the guide shaft 1, thus playing a pre-shaping role. When the shaping member 5 is positioned close to the proximal end of the basket, the maximum outer diameter of the shaping member 5 is greater than the outer diameter of the circle containing the proximal end of the basket. More preferably, the maximum outer diameter of the shaping member 5 is less than the maximum outer diameter of the outer tube 11 and the maximum outer diameter of the retracting member 7 at the distal end of the basket.

[0238] Furthermore, the radial dimension of at least one of the distal and proximal ends of the shaping member 5 is not greater than the inner diameter of the circle containing the end of the basket structure 6. This is to prevent the end of the shaping member 5 from compressing the end of the basket structure 6 when the basket structure 6 switches from a contracted state to an expanded state, thus preventing stress concentration and subsequent bending and cracking of the basket structure 6. For example, when the shaping member 5 is disposed on the inner shaft 10 near the distal end of the basket, the outer diameter of the proximal end of the shaping member 5 is smaller than the inner diameter of the circle containing the proximal end of the basket. In this way, when the basket structure 6 switches from a contracted state to an expanded state, the proximal end of the shaping member 5 will not compress the proximal end of the basket, reducing the possibility of bending and cracking.

[0239] Preferred, such as Figure 8 As shown, at least a portion of the shaping member 5 has a distal outer diameter near the distal end of the conduit shaft 1 that is smaller than the proximal outer diameter near the proximal end of the shaping member 5 that is closer to the conduit shaft 1. That is, the shaping member 5 can be designed as a variable diameter structure to better enable the basket structure 6 to form a predetermined working shape.

[0240] The shaping component 5 can be made of elastic materials such as Pebax (polyether block polyamide) and polyurethane, and the shaping component 5 is bonded and fixed to the inner shaft 10 or the outer tube 11.

[0241] Preferably, the length of the shaping component 5 is between 1mm and 5mm.

[0242] Preferably, the distance between the shaping component 5 and the gathering component 7 disposed on the guide shaft 1 for gathering the distal end of the basket is no greater than 5 mm. Preferably, the gathering component 7 is the end electrode 2, the stress diffusion component 4, or other components that gather the distal end of the basket.

[0243] Preferably, the basket structure 6 includes a superelastic shape memory alloy 36 to improve the shape retention capability of the basket structure 6.

[0244] On the other hand, combining Figure 2 and Figure 7 This invention provides a catheter for treating target tissue, comprising a catheter shaft 1 and a basket structure 6. The basket structure 6 is disposed at the distal end of the catheter shaft 1 and has a contracted state and an expanded state. In the contracted state, the basket structure 6 retracts towards the catheter shaft 1 to ensure that the catheter can safely reach the area where the target tissue is located. In the expanded state, at least a portion of the basket structure 6 moves from the position retracted towards the catheter shaft 1 to a position away from the catheter shaft 1.

[0245] The basket structure 6 includes a proximal end and a distal end, which are capable of relative movement to allow the basket structure 6 to switch between the contracted state and the expanded state.

[0246] The catheter also includes a shaping member 5 disposed within the basket structure 6. The shaping member 5 is sleeved on the catheter shaft 1. In the contracted state, the shaping member 5 acts on at least one of the proximal end and the distal end of the basket, causing the at least one of the proximal end and the distal end of the basket to bulge outward away from the catheter shaft 1.

[0247] In this embodiment, the basket structure 6 includes, but is not limited to, the electrode assembly 3 in the aforementioned embodiments. The catheter includes, but is not limited to, the electrophysiological catheter 1005 in the aforementioned embodiments.

[0248] On the other hand, combining Figure 2 and Figure 10 This invention provides an electrode carrier that can be disposed at the distal end of a conduit and includes a transmission line 32 and a blind line 33. The transmission line 32 is electrically connected to an electrode 31, and the blind line 33 is electrically connected to a power supply unit but does not form an electrical circuit.

[0249] When the electrode carrier 30 is working normally, the blind circuit 33 and the transmission line 32 do not conduct electricity; when the electrode carrier 30 is cracked, the blind circuit 33 and the transmission line 32 conduct electricity and form an electrical circuit with the power supply unit.

[0250] Under normal conditions, when the blind circuit 33 is energized, it does not form an electrical circuit because it is electrically insulated from the transmission line 32. When the electrode carrier 30 cracks, the blind circuit 33 is exposed to the external environment. Blood can act as a conductive medium, causing the insulation between the blind circuit 33 and the transmission line 32, which needs to transmit energy, to fail, thus forming an electrical circuit and generating current. This current can be detected by a crack detection module (such as a current sensor), which can then determine whether the electrode carrier 30 is cracked. Cracks can also be detected by impedance detection, which uses high frequency and low voltage (1kHz to 100kHz, below 5V) for impedance detection.

[0251] In this embodiment, the catheter includes, but is not limited to, the electrophysiological catheter 1005 in the aforementioned embodiments.

[0252] On the other hand, combining Figures 1-4 This invention provides an electrophysiological catheter 1005 for ablation of target tissue, including a catheter shaft 1 and an electrode assembly 3, wherein the electrode assembly 3 is disposed at the distal end of the catheter shaft 1.

[0253] The electrode assembly 3 includes the electrode carrier 30 as described above and the electrode 31 located on the electrode carrier 30.

[0254] Furthermore, the electrode 31 includes an inner electrode 310 and an outer electrode 311. The inner electrode 310 is located on the side of the electrode carrier 30 near the catheter shaft 1, and the outer electrode 311 is located on the side of the electrode carrier 30 away from the catheter shaft 1. The outer electrode 311 is closer to the distal end of the catheter shaft 1 than the inner electrode 310.

[0255] On the other hand, combining Figure 10 and Figure 15 This invention provides a high-voltage pulse ablation system, including a power supply unit 1001, a main control module 1002, an electrode combination switch 1003, a user interface 1004, and an electrophysiological catheter 1005 as described above.

[0256] The main control module 1002 is used to send working instructions;

[0257] The power supply unit 1001 is communicatively connected to the main control module 1002 and is used to transmit high-voltage pulses to the electrode assembly 3 according to the working instructions.

[0258] The electrode combination switch 1003 is communicatively connected to the main control module 1002 and is used to select the transmission line 32 that needs to transmit energy according to the working instruction in order to realize the paired discharge of the electrode assembly 3.

[0259] The user interface 1004 is communicatively connected to the main control module 1002 and is used for human-computer interaction to control the high-voltage pulse ablation system and display information.

[0260] The power supply unit 1001 is also used to energize the blind line 33 and the transmission line 32 that needs to be discharged, so that the polarity of the blind line 33 is opposite to the polarity of at least one of the transmission lines 32.

[0261] The ablation system also includes a crack detection module 1006 that is communicatively connected to the main control module 1002. The crack detection module 1006 is used to detect whether there is continuity between the blind line 33 and the transmission line 32. If there is continuity, a crack signal is sent to the main control module 1002.

[0262] Under normal conditions, since the blind circuit 33 is electrically insulated from the external environment, it does not form an electrical circuit with the transmission line 32, and the crack detection module 1006 cannot detect the current generated between the normally discharging transmission line 32 and the blind circuit 33. When the electrode carrier 30 cracks, the blind circuit 33 is exposed to the external environment. Blood can act as a conductive medium, causing the insulation between the blind circuit 33 and the discharging transmission line 32 to fail, thereby forming an electrical circuit and generating current. The crack detection module 1006 can detect this current and send a crack signal to the main control module 1002. The main control module 1002 interrupts the discharge of the high-voltage pulse electric field generator to end the treatment based on the crack signal, or provides a warning (such as issuing an alarm) to improve system safety.

[0263] Preferably, the transmission line 32 for the discharge is a transmission line 32 adjacent to the blind line 33.

[0264] In this embodiment, the power supply unit 1001 includes a high-voltage pulse electric field generator, which can transmit high-voltage pulses to the blind line 33.

[0265] Preferably, the power supply unit 1001 further includes a low-voltage generator. In the non-discharge state, the electrode combination switch 1003 can switch to be connected to the low-voltage generator, replacing the high-voltage pulse electric field generator to energize the blind circuit 33. The two poles of the low-voltage generator are electrically connected to the blind circuit 33 and at least one of the transmission lines 32, respectively. Since the low-voltage generator continuously releases a low-voltage signal, the current can be detected in real time by the crack detection module 1006. By transmitting an electrical signal to the blind circuit 33 through the low-voltage generator, the insulation design of the electrode carrier 30 can be reduced, while ensuring treatment safety.

[0266] 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. An electrophysiology catheter for use in ablation of target tissue, characterized by, It includes a catheter shaft and an electrode segment, wherein the electrode segment is disposed at the distal end of the catheter shaft; The electrode segment includes an end electrode and an electrode assembly, the electrode assembly being closer to the proximal end of the catheter axis relative to the end electrode; The electrode assembly includes at least one electrode carrier and a plurality of electrodes located on the electrode carrier. When the end electrode ablates the target tissue, the end electrode is paired with at least one of the plurality of electrodes located on the electrode carrier to discharge. There are multiple electrode carriers electrically connected to the end electrode. The electrode carrier where at least one of the electrodes participating in the paired discharge is located is a different electrode carrier from the electrode carrier electrically connected to the end electrode. The electrode carrier where at least one of the electrodes participating in the paired discharge is located is alternately arranged with the electrode carrier electrically connected to the end electrode in the circumferential direction of the conduit shaft.

2. The electrophysiology catheter of claim 1, wherein, The electrode assembly includes a plurality of inner electrodes located on the side of the electrode carrier near the conduit axis, and the inner electrodes include at least one of the electrodes participating in the paired discharge; The electrode carrier of the electrode assembly includes a proximal end and a distal end, which are capable of relative movement to allow the electrode carrier of the electrode assembly to switch between a contracted state and an expanded state.

3. The electrophysiological catheter according to claim 2, characterized in that, The inner electrode is positioned toward the distal end of the conduit axis.

4. The electrophysiological catheter according to claim 2, characterized in that, The inner electrode has at least a first position and a second position; In the first position, the electrode carrier where the inner electrode is located is in a contracted state, and the electrode carrier is drawn towards the duct axis. In the second position, the electrode carrier is in an expanded state, and at least a portion of the electrode carrier moves from a position that converges toward the catheter axis to a position that moves away from the catheter axis, with the inner electrode facing the distal end of the catheter axis.

5. The electrophysiological catheter according to any one of claims 2-4, characterized in that, The electrode assembly also includes several outer electrodes located on the side of the electrode carrier away from the conduit axis, and the outer electrodes are closer to the end electrode than the inner electrodes.

6. The electrophysiological catheter according to claim 5, characterized in that, The inner electrode has at least a third position, in which the electrode carrier on which the inner electrode is located is in an expanded state, and at least a portion of the inner electrode and at least a portion of the outer electrode act on the target tissue and ablate it.

7. The electrophysiological catheter according to claim 2, characterized in that, The electrophysiological catheter also includes a shaping element disposed within the electrode assembly. The shaping element is sleeved on the catheter shaft. In the contracted state, the shaping element acts on at least one of the proximal end and the distal end of the carrier, causing the at least one of the proximal end and the distal end of the carrier to protrude outward away from the catheter shaft. The length of the shaping element is between 1 mm and 5 mm.

8. The electrophysiological catheter according to claim 2, characterized in that, The electrophysiological catheter also includes a shaping member disposed within the electrode assembly. The shaping member is sleeved on the catheter shaft. In the contracted state, the shaping member acts on at least one of the proximal end and the distal end of the carrier, causing the at least one of the proximal end and the distal end of the carrier to protrude outward away from the catheter shaft. The distance between the shaping member and the gathering member disposed on the catheter shaft for gathering the distal end of the carrier is no greater than 5 mm.

9. The electrophysiological catheter according to claim 7 or 8, characterized in that, The conduit shaft includes an inner shaft and an outer tube, the inner shaft and the outer tube are capable of relative movement, the proximal end of the carrier is disposed on the outer tube, and the distal end of the carrier is disposed on the inner shaft; The shaping component is disposed on the inner shaft near the far end of the carrier.

10. The electrophysiological catheter according to claim 7 or 8, characterized in that, The shaping component has a variable diameter structure to enable the electrode carrier to form a predetermined working shape.

11. The electrophysiological catheter according to claim 7 or 8, characterized in that, The radial dimension of at least one of the distal end and proximal end of the shaping component is not greater than the inner diameter of the circle containing the end of the electrode carrier.

12. The electrophysiological catheter according to any one of claims 1-4 and 6-8, characterized in that, At least one electrode carrier of the electrode assembly includes a transmission line and a blind line. The transmission line is electrically connected to the electrode of the electrode assembly, and the blind line is electrically connected to the power supply unit but does not form an electrical circuit. When the electrode assembly is working normally, the blind circuit and the transmission line do not conduct electricity; when the electrode carrier is cracked, the blind circuit and the transmission line conduct electricity and form an electrical circuit with the power supply unit.

13. The electrophysiological catheter according to any one of claims 1-4 and 6-8, characterized in that, At least one electrode carrier of the electrode assembly is provided with a superelastic shape memory alloy to improve its shape retention capability.

14. A high-voltage pulse ablation system, characterized in that, Includes a power supply unit, a main control module, an electrode combination switch, a user interface, and an electrophysiological catheter according to any one of claims 1-13; The main control module is used to send work instructions; The power supply unit is communicatively connected to the main control module and is used to deliver high-voltage pulses to the electrode segments of the electrophysiological catheter according to the working instructions. The electrode combination switch is communicatively connected to the main control module and is used to select the transmission line of the electrode carrier of the electrode assembly that needs to transmit energy according to the working instruction so as to realize the paired discharge of the electrode segments. The user interface is communicatively connected to the main control module and is used for human-computer interaction to control and display information about the high-voltage pulse ablation system.

15. The high-voltage pulse ablation system according to claim 14, characterized in that, The high-voltage pulse ablation system includes at least one of the following operating modes: In the first working mode, ablation is performed through the end electrode; In the second working mode, the electrode segment is in an expanded state, and ablation is performed through the end electrode and / or the outer electrode of the electrode assembly; In the third working mode, the electrode segment is in an expanded state, and ablation is performed through the inner electrode and the outer electrode of the electrode assembly.

16. The high-voltage pulse ablation system according to claim 15, characterized in that, The main control module can selectively control the end electrode, the outer electrode, and the inner electrode.

17. A high-voltage pulse ablation system, characterized in that, Includes a power supply unit, a main control module, an electrode combination switch, a user interface, and the electrophysiological catheter according to claim 12; The main control module is used to send work instructions; The power supply unit is communicatively connected to the main control module and is used to deliver high-voltage pulses to the electrode segments of the electrophysiological catheter according to the working instructions. The electrode combination switch is communicatively connected to the main control module and is used to select the transmission line that needs to deliver energy according to the working instruction in order to realize the paired discharge of the electrode segments. The user interface is communicatively connected to the main control module and is used for human-computer interaction to control the high-voltage pulse ablation system and display information. The power supply unit is also used to energize the blind line and the transmission line that needs to be discharged, so that the polarity of the blind line is opposite to that of at least one of the transmission lines. The ablation system also includes a crack detection module that is communicatively connected to the main control module. The crack detection module is used to detect whether there is continuity between the blind line and the transmission line. If there is continuity, a crack signal is sent to the main control module.

18. The high-voltage pulse ablation system according to claim 17, characterized in that, The power supply unit delivers high-voltage pulses to the blind line.

19. The high-voltage pulse ablation system according to claim 17, characterized in that, The power supply unit also includes a low-voltage generator. In the non-discharge state, the electrode combination switch can be switched to be connected to the low-voltage generator. The two poles of the low-voltage generator are electrically connected to the blind line and at least one of the transmission lines, respectively.

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