Dual-energy discharge ablation catheter

Abstract

The application provides a dual-energy discharge ablation catheter, and a energy output electrode group is formed at the distal end of the catheter, wherein the energy output electrode group at least comprises a combined electrode and a first pulse discharge electrode, and the catheter is configured to: in a radio frequency ablation mode, discharge is performed by at least part of the combined electrode; in a pulse electric field ablation mode, a second pulse discharge electrode is formed by at least part of the combined electrode, the polarity of the first pulse discharge electrode and the second pulse discharge electrode is opposite; the combined electrode comprises two or more electrode parts, each electrode part is arranged in a spaced manner along the catheter axis direction, and at least one pair of adjacent two electrode parts is separated by an insulating structure. Through the innovative design of the combined electrode, the application realizes efficient cooperation and function adaptation of the two modes of radio frequency ablation and pulse electric field ablation, and solves many pain points of the existing dual-mode catheter in energy output, operation safety, abutting adaptation and the like, and has extremely high clinical application value.

Description

Technical Field

[0001] This invention relates to the field of cardiovascular interventional device technology, and in particular to a dual-energy discharge ablation catheter. Background Technology

[0002] Currently, electrophysiological ablation catheters are widely used in the treatment of diseases such as arrhythmias. The ablation energies commonly used in clinical practice mainly include radiofrequency ablation and pulsed electric field ablation. Radiofrequency ablation relies on thermal effects to achieve coagulative necrosis of tissue, and has a good ablation effect on thicker myocardial tissue. Pulsed electric field ablation relies on high-voltage pulsed electric fields to achieve irreversible electroporation of cells, and has advantages such as high tissue selectivity, controllable damage, and small thermal effects.

[0003] To improve surgical efficiency and expand indication coverage, dual-mode ablation catheters capable of simultaneously supporting radiofrequency ablation and pulsed electric field ablation have become the industry's development direction. However, most existing dual-mode ablation catheters employ simple multi-electrode arrangements, making it difficult to simultaneously adapt to the optimal operating conditions of both energy modes. The technical challenges include: radiofrequency ablation requires a larger effective discharge area to reduce contact impedance and improve energy output and ablation depth; while pulsed electric field ablation requires a controllable and uniform electrode pair structure to form a stable electric field and avoid tip discharge. Existing multi-electrode arrangements are fixed, making it difficult to achieve ideal energy output and electric field distribution in both modes. Integrated electrodes can only achieve overall contact assessment and cannot identify localized suspension or poor contact, easily leading to insufficient ablation or localized overheating. Furthermore, the integrated structure is not conducive to achieving independent saline perfusion in multiple areas, making it difficult to effectively reduce the risk of tissue rupture (POP) in radiofrequency mode and to improve electric field distribution and reduce hemolysis risk in pulsed electric field ablation mode. Summary of the Invention

[0004] In view of this, embodiments of the present invention provide a dual-energy discharge ablation catheter to eliminate or improve one or more defects existing in the prior art.

[0005] The distal end of the catheter is provided with an energy output electrode assembly, which includes at least one combined electrode and a first pulse discharge electrode. The catheter is configured such that, in radiofrequency ablation mode, at least a portion of the combined electrode discharges; and in pulsed electric field ablation mode, at least a portion of the combined electrode forms a second pulse discharge electrode, wherein the first pulse discharge electrode and the second pulse discharge electrode have opposite polarities. The combined electrode comprises two or more electrode segments, which are spaced apart along the axial direction of the catheter, and at least one pair of adjacent electrode segments are separated by an insulating structure.

[0006] In some embodiments, the insulating structure includes an insulating pad, and each of the electrode components is connected by its own wire to a cable connector near the end of the conduit, such that each electrode component is isolated from the others and can individually measure its own contact resistance.

[0007] In some embodiments, each of the electrode segments is a ring electrode, or the electrode segment located at the farthest end is a cap-shaped electrode, and the remaining electrode segments are ring electrodes.

[0008] In some embodiments, the combined electrode includes two electrode components, namely a first electrode and a second electrode, wherein the first electrode is located at the far end of the conduit and the length of the first electrode is shorter than that of the second electrode.

[0009] In some embodiments, a plurality of circumferential grooves are formed on the surface of the first pulse discharge electrode; the conduit has a bendable structure formed in the section where the first pulse discharge electrode is located, the bendable structure including at least one of a tapering structure, circumferential grooves, a heat-treated low-stiffness region, and a low-strength dissimilar material region.

[0010] In some embodiments, the first pulse discharge electrode is a spring-wound structure formed by spirally winding an elastic filament; the filament has multiple turns, and at least every other turn, adjacent turns of filament are welded and fixed on opposite sides along their axial direction, with a welding length of 0.1~1mm; the cross-sectional profile of the filament is circular or includes rounded corners.

[0011] In some embodiments, a plurality of first discharge ports are formed on the first electrode; a plurality of second discharge ports are formed on the second electrode; a plurality of third discharge ports are formed on the conduit and connected to the overcurrent structure of the first pulse discharge electrode; each discharge port is used to discharge coolant.

[0012] In some embodiments, the catheter further includes at least one mapping electrode; when there are two or more mapping electrodes, the mapping electrodes are spaced apart along the axial direction of the catheter.

[0013] In some embodiments, the conduit includes: a tube body and an adapter, the adapter being connected to the distal end of the tube body; the tube body includes a dual-lumen section, the first pulse discharge electrode and the mapping electrode being located in the dual-lumen section, one lumen of the dual-lumen section being used for passing through or forming a coolant conduit, and the other lumen being used for passing through the wires of each electrode.

[0014] In some embodiments, the catheter includes a bending control assembly, which includes a bending control ring, a rigid adapter, a bending control wire, and a bending control handle. The catheter body has a bending control section located on the proximal side of the dual-lumen section. The bending control ring is fixedly sleeved on the inner or outer wall of the bending control section of the catheter body. The bending control ring is fixedly connected to one end of the bending control wire via the rigid adapter, and the other end of the bending control wire is fixedly connected to the bending control handle. The rigid adapter is fixed within an eccentric cavity in the bending control section and has a set length along the axial direction of the catheter, such that the bending control ring and the flexible and bendable bending control wire are offset in the axial direction.

[0015] In some embodiments, the first electrode is bonded to the distal end of the adapter; the second electrode is pressed against the outer periphery of the adapter; the insulating gasket is bonded to the adapter, and its two axial sides are adjacent to the first electrode and the second electrode, respectively.

[0016] In some embodiments, the bonding portion of the first electrode has an enlarged diameter structure; and / or, the annular portion of the adapter for bonding with the first electrode has an uneven structure that increases the surface area; and / or, the adapter is made of an insulating rigid material, and a first annular groove is formed at the portion where the insulating gasket is installed, and a second annular groove is formed at the portion where the second electrode is installed; and / or, the outer diameters of the first electrode and the second electrode are the same, and the outer surfaces of the first electrode and the second electrode protrude from the outer surface of the tube body.

[0017] In some embodiments, a semiconductive adhesive for sealing with the tube body is provided at the proximal end of the second electrode and at both ends of the first pulse discharge electrode, the volume resistivity of which is configured to be 10. 4 -10 10 Between Ω·m.

[0018] In some embodiments, the distal end of the tube body has a countersunk structure, and an enlarged diameter section is formed inside the countersunk structure. The proximal end of the adapter has a plug section and a snap-fit ​​section located at the proximal end, and the snap-fit ​​section is installed on the enlarged diameter section.

[0019] In some embodiments, the first electrode and the second electrode are configured to be connected in parallel; and / or, the width of the insulating pad is configured to be 0.1~1mm.

[0020] In some embodiments, the first electrode is connected to the cable connector via a first wire, the distal end of which is connected to the circumferential inner wall or end inner wall of the first electrode; the second electrode is connected to the cable connector via a second wire, the distal end of which is connected to the circumferential inner wall of the second electrode; and the first pulse discharge electrode is connected to the cable connector via a third wire, the distal end of which is connected to the circumferential inner wall of the first pulse discharge electrode.

[0021] In some embodiments, the first conductor includes a safety wire, one end of which is welded to the first electrode, and the other end of the safety wire or the middle section of the first conductor is fixed to the bending control ring.

[0022] In some embodiments, the conduit further includes a thermal sensor disposed within the first electrode, wherein the sensing portion of the thermal sensor is located on the distal plane, outer peripheral surface, or within the first electrode.

[0023] In some embodiments, the thermal sensor is disposed at the center hole of the distal end of the first electrode, the thermal sensor is encapsulated in the first electrode, its end is flush with the plane of the distal end of the first electrode, and is sealed and fixed by potting compound.

[0024] In some embodiments, the thermal sensor is encapsulated within the first electrode by a thermal insulation structure to isolate it from coolant.

[0025] In some embodiments, the heat insulation structure includes: an outer PI tube and an inner PI tube, with a gap formed between the annular walls of the outer PI tube and the inner PI tube; the distal end of the outer PI tube is unfolded and bonded to the inner wall plane of the end of the first electrode.

[0026] In some embodiments, the adapter has a central hole extending along its axial direction and a side hole that connects the central hole and the second discharge port, allowing coolant in the central hole to enter the second discharge port through the side hole.

[0027] In some embodiments, the minimum cross-sectional area of ​​the main pipe upstream of the third discharge port of the coolant pipe is A, the sum of the cross-sectional areas of all the first discharge ports of the first electrode is m, the sum of the cross-sectional areas of all the second discharge ports of the second electrode is n, and the sum of the cross-sectional areas of all the third discharge ports of the first pulse discharge electrode is p, satisfying: A≥m+n+p, and / or, m=n, and / or, p<1 / 3(m+n+p).

[0028] In some embodiments, the proximal end of the conduit is further provided with a Luer connector that communicates with the coolant conduit.

[0029] This invention, through its integrated design of combined electrodes, eliminates the need for separate electrode structures for radiofrequency and pulse modes, simplifying the overall catheter structure, reducing the number of electrodes, leads, and other components, and lowering manufacturing difficulty and cost. Furthermore, in clinical use, it allows for rapid switching between radiofrequency and pulse modes without catheter replacement, shortening surgical time, reducing the use of disposable consumables, lowering clinical treatment costs, improving surgical efficiency, and alleviating the treatment burden on patients.

[0030] Additional advantages, objects, and features of the invention will be set forth in part in the description which follows, and will also become apparent in part to those skilled in the art upon studying the description, or may be learned by practice of the invention. The objects and other advantages of the invention can be realized and obtained by means of the structures specifically pointed out in the description and drawings.

[0031] Those skilled in the art will understand that the objectives and advantages achievable with the present invention are not limited to those specifically described above, and that the above and other objectives achievable with the present invention will become clearer from the following detailed description. Attached Figure Description

[0032] The accompanying drawings, which are included to provide a further understanding of the invention and form part of this application, are not intended to limit the scope of the invention. The components in the drawings are not drawn to scale but are merely illustrative of the principles of the invention. For ease of illustration and description of certain parts of the invention, corresponding portions in the drawings may be enlarged, i.e., may appear larger relative to other components in an exemplary device actually manufactured according to the invention.

[0033] Figure 1 This is an overall structural diagram of the dual-energy discharge ablation catheter according to an embodiment of the present invention.

[0034] Figure 2 for Figure 1 A magnified view of part I in the middle section.

[0035] Figure 3 for Figure 1 A magnified view of a section of the middle part (II).

[0036] Figure 4 This is a partial cross-sectional view of the distal end of the catheter in one embodiment of the present invention.

[0037] Figure 5 This is a schematic diagram of the state of the dual-energy discharge ablation catheter after bending in one embodiment of the present invention.

[0038] Figure 6 This is a schematic diagram of the structure of the first pulse discharge electrode in another embodiment of the present invention.

[0039] Figure 7 This is a half-sectional view of the distal end of the catheter in one embodiment of the present invention.

[0040] Figure 8 This is a schematic diagram of a partial segment of the distal end of the catheter in one embodiment of the present invention.

[0041] Figure 9 This is a schematic diagram of the end face of the double-lumen segment of the catheter in one embodiment of the present invention.

[0042] Figure 10 This is a schematic diagram of the adapter structure in one embodiment of the present invention.

[0043] Figure 11 This is a schematic diagram of a second electrode hidden at the distal end of a catheter in one embodiment of the present invention.

[0044] Figure 12 This is a partial structural schematic diagram of the bending control component in one embodiment of the present invention.

[0045] Figure 13 This is a schematic diagram of the assembly of the bending control component in the bending control section according to an embodiment of the present invention.

[0046] Figure 14 This is a schematic diagram of the distal end of the catheter from an external perspective in one embodiment of the present invention.

[0047] Figure 15 This is a structural schematic diagram of the distal end of the catheter in one embodiment of the present invention, viewed from an internal perspective.

[0048] Figure 16 This is a view showing the wire distribution and coolant piping design at the distal end of the dual-energy discharge ablation catheter in one embodiment of the present invention.

[0049] Figure label: 1. Energy output electrode assembly; 110. Combined electrode; 111, First electrode; 112, Second electrode; 113, Insulating pad; 121, First pulse discharge electrode; 121-1, Groove; 121-2, Wire; 201, Fourth electrode; 202, Fifth electrode; a. First emission port; b. Second emission port; c. Third emission port; 111-1. Expansion structure; 310. Adapter; 311. First convex ring section; 311-1. Adhesive groove; 312. First annular groove; 313. Second convex ring section; 314. Second annular groove; 315. Third convex ring section; 316. Plug-in section; 317. Snap-in section; 318. Center hole; 319-1. Overcurrent side hole; 319-2. Wire side hole; 320. Pipe body; 321. Double-lumen section; 321-1. Double-lumen section conductor lumen; 321-2. Double-lumen section coolant lumen; 322. Bending control section; 322-1. Four-lumen section conductor lumen; 322-2. Four-lumen section coolant lumen; 322-3. Eccentric cavity; 323. Single-lumen section; 320-3. Tapering structure; 320-1. Countersunk hole structure; 320-2. Expanded diameter section; 410. Bending control ring; 420. Rigid adapter; 430. Bending control screw; 440. Bending control handle; 441. Handle body; 442. Handle core; e. Semiconducting adhesive; 501. Thermal sensor; 502. Outer PI tube; 503. Inner PI tube; 502-1. Cutting unfolding; 6. Cable connector; 610. First conductor; 620. Second conductor; 630. Third conductor; 7. Luer connector. Detailed Implementation

[0050] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the embodiments and accompanying drawings. Here, the illustrative embodiments and descriptions of this invention are used to explain the invention, but are not intended to limit the invention.

[0051] It should also be noted that, in order to avoid obscuring the invention with unnecessary details, only the structures and / or processing steps closely related to the solution according to the invention are shown in the accompanying drawings, while other details that are not closely related to the invention are omitted.

[0052] It should be emphasized that the term "including / comprises" as used herein refers to the presence of a feature, element, step, or component, but does not exclude the presence or addition of one or more other features, elements, steps, or components.

[0053] It should also be noted that, unless otherwise specified, the term "connection" in this article can refer not only to a direct connection, but also to an indirect connection involving an intermediary.

[0054] In the following description, embodiments of the invention will be illustrated with reference to the accompanying drawings. In the drawings, the same reference numerals represent the same or similar parts, or the same or similar steps.

[0055] This invention provides a dual-energy discharge ablation catheter. Through the innovative design of the combined electrode 110, it achieves efficient synergy and functional compatibility between radiofrequency ablation and pulsed electric field ablation (PFA) modes. At the same time, it solves many pain points of existing dual-mode catheters in terms of energy output, operation safety, and fit, and has extremely high clinical application value.

[0056] Understandably, in the context of this dual-energy ablation catheter, the terms "distal" and "proximal" are relative definitions based on the location of the catheter during clinical use, with "closer to the lesion site inside the body" being the distal end and "closer to the external operating end" being the proximal end.

[0057] like Figures 1-5 As shown, an energy output electrode group 1 is formed at the distal end of the conduit, and the energy output electrode group 1 includes at least a combined electrode 110 and a first pulse discharge electrode 121.

[0058] The catheter is configured such that, in radiofrequency ablation mode, at least a portion of the combined electrode 110 discharges; and in pulsed electric field ablation mode, at least a portion of the combined electrode 110 forms a second pulsed discharge electrode, wherein the polarity of the first pulsed discharge electrode 121 is opposite to that of the second pulsed discharge electrode.

[0059] The combined electrode 110 includes two or more electrode components, each of which is arranged at intervals along the axial direction of the conduit, and at least one pair of adjacent electrode components is separated by an insulating structure.

[0060] The phrase "at least part of the combined electrode 110" as used herein refers to the fact that the electrode components for discharge can be a portion of the combined electrode 110 or all of the electrodes in the combined electrode 110. Because the combined electrode 110 consists of multiple electrode components spaced apart along the axis of the conduit, and adjacent electrode components are separated by an insulation structure of reasonable width, short circuits between electrodes are avoided, and the effective discharge area is not interrupted. The multiple electrode components together constitute a larger equivalent effective discharge area.

[0061] In radiofrequency ablation mode, compared with conventional single integrated single-head electrode, the larger discharge area can significantly reduce the contact impedance between the electrode and the tissue. Under the same voltage conditions, the energy output is more stable and sufficient, thereby improving the ablation depth and ablation efficiency. It is especially suitable for the ablation of thicker myocardial tissue, solving the problems of limited energy output and insufficient ablation depth of traditional integrated electrodes.

[0062] In the pulsed electric field ablation mode, the second pulsed discharge electrode formed by some or all of the electrodes of the combined electrode 110 works in conjunction with the first pulsed discharge electrode 121 to precisely control the electric field strength and range of action. Combined with the reasonable layout of the insulation structure, it effectively suppresses tip discharge, reduces damage to blood cells by high-voltage pulses, and lowers the risk of hemolysis. At the same time, the uniform electric field distribution can avoid excessive damage to local tissues and improve the safety and controllability of pulsed ablation.

[0063] Compared to a single-piece electrode, the modular electrode 110's split structure reduces overall electrode rigidity, making the catheter tip more flexible and better adaptable to the curved contours of complex anatomical structures such as the heart chambers. This reduces localized suspension caused by excessive electrode rigidity and improves the adhesion between the electrode and tissue. Furthermore, the two separate electrodes are spaced apart along the catheter axis, allowing them to fit different curved tissue areas, further enhancing the flexibility and adaptability of the fit and meeting the ablation needs of various anatomical locations.

[0064] Each individual electrode is independent and can be used to detect the adhesion resistance between itself and the tissue. By comparing the adhesion resistance of the two individual electrodes, the operator can accurately judge the overall uniformity of the adhesion of the combined electrode, effectively identify false positives such as "overall adhesion is qualified, but local suspension", avoid problems such as insufficient ablation, energy waste or local overheating caused by poor local adhesion, and improve the accuracy of adhesion judgment and the reliability of ablation.

[0065] Compared to integrated electrodes, the two separate electrodes can deform synchronously with the bending of the catheter, reducing local stress concentration when the electrodes are in contact with the tissue and avoiding tissue damage caused by excessive stress. At the same time, the separate structure can make the contact pressure between the electrodes and the tissue more uniform, improve the durability of the contact, avoid the contact falling off due to slight displacement of the catheter during the operation, and further ensure the stability of the ablation effect.

[0066] Furthermore, the modular electrode 110 can be configured to allow for the selection of individual electrodes to participate in radiofrequency discharge, or to be combined to form second pulse discharge electrodes of different specifications, depending on the surgical requirements. This adapts to the ablation needs of different locations and tissues of different thicknesses, expanding the clinical indications of the catheter. It eliminates the need to replace the catheter for different ablation scenarios, thus improving the convenience of the procedure.

[0067] This invention, through the integrated design of the combined electrode 110, eliminates the need for separate electrode structures for radiofrequency and pulse modes, simplifying the overall catheter structure, reducing the number of electrodes, leads, and other components, and lowering manufacturing difficulty and cost. Furthermore, in clinical use, it allows for rapid switching between radiofrequency and pulse modes without catheter replacement, shortening surgical time, reducing the use of disposable consumables, lowering clinical treatment costs, improving surgical efficiency, and alleviating the treatment burden on patients.

[0068] In some embodiments, such as Figure 3As shown, the insulating structure includes an insulating pad 113, and each electrode component is connected to a cable connector 6 near the proximal end of the conduit by its own wire, thus isolating each electrode component from the others and allowing for individual measurement of its own contact resistance. This design allows for individual measurement of the contact resistance between each electrode component and the tissue. By comparing the resistance values ​​of different electrode components, the overall uniformity of electrode contact can be accurately determined, identifying false positives such as "overall contact is acceptable, but some areas are suspended," avoiding problems such as insufficient ablation, energy waste, or local overheating caused by poor local contact, thereby improving the accuracy of ablation.

[0069] Furthermore, the insulation structure between adjacent electrode sections not only prevents short circuits between electrodes but also improves the overall structural stability of the electrodes. At the same time, the insulating pad 113 can have a certain degree of flexibility. The split design can reduce the overall rigidity of the electrodes, making the distal end of the catheter more flexible and better able to adapt to complex in vivo anatomical structures (such as the pulmonary vein orifice, auricle, etc.), improve the stability of the fit, reduce ablation deviation caused by catheter displacement during the operation, and reduce the risk of surgical complications.

[0070] Optionally, to balance insulation reliability and effective discharge area, the width of the insulating pad 113 is configured to be 10.1~1mm. This width range can effectively achieve electrical isolation between the first electrode 111 and the second electrode 112 to prevent short circuits between the electrodes, while avoiding excessive fragmentation of the effective discharge area of ​​the combined electrode 110. This ensures that a continuous equivalent discharge surface is formed when the two electrodes discharge together, guaranteeing energy output and ablation depth in radio frequency mode. At the same time, it avoids electric field distortion caused by excessively wide pads, adapting to the electric field distribution requirements in pulse mode.

[0071] In some embodiments, each of the electrodes is a ring electrode, or, as... Figure 7 As shown, the electrode at the farthest end is a cap-shaped electrode, while the remaining electrodes are ring-shaped electrodes. A cap-shaped electrode refers to an electrode with a flat end face and a ring-shaped circumferential surface, forming a structure similar to a cap. The flat end face facilitates stable contact with the target tissue, while the ring-shaped circumferential surface increases the electrode surface area, which is beneficial for improving energy output efficiency in radiofrequency ablation mode and ensuring uniform electric field distribution in pulsed electric field ablation mode. The cap-shaped electrode at the farthest end is more conducive to stable contact with the tissue and achieving radiofrequency energy output, and also facilitates the formation of electrode pairs with clear polarity and uniform electric field in pulsed electric field ablation mode.

[0072] As at least one possible way, such as Figures 2-5 and Figure 7As shown, the combined electrode 110 includes two electrode components: a first electrode 111 and a second electrode 112. The first electrode 111 is located at the distal end of the catheter, serving as the ablation electrode at the very tip of the catheter. The length of the first electrode 111 is shorter than that of the second electrode 112, and the two electrodes are arranged sequentially along the catheter axis. The first electrode 111 is a short electrode, and the second electrode 112 is a long electrode; they are separated by an insulating structure and form an integral combined electrode 110.

[0073] Furthermore, the first electrode 111 is configured as a short electrode located at the farthest end, which helps to improve the flexibility of the catheter tip and enhance its adhesion stability to the tissue; the second electrode 112 is configured as a long electrode, which can increase the effective discharge area and improve energy output and ablation range. The combination of long and short electrodes can balance adhesion performance and ablation effect, enabling the catheter to achieve optimal energy output in both radiofrequency ablation and pulsed electric field ablation modes.

[0074] The shorter length of the first electrode 111, located at the distal end, reduces the rigidity of the catheter tip, making it easier to bend and deform. This allows for better contact with complex anatomical structures such as the cardiac chamber wall, reducing local suspension and improving uniformity of contact and ablation reliability. The combination of long and short electrodes makes the catheter tip lighter and more flexible, facilitating angle adjustments in complex anatomical structures for precise contact. Simultaneously, the short electrode can penetrate into narrow anatomical areas (such as the pulmonary vein orifice) for contact, while the long electrode provides a larger contact area. The synergistic effect of both ensures precise and stable contact, guaranteeing effective delivery of ablation energy to the target tissue.

[0075] The first electrode 111 and the second electrode 112 are arranged compactly along the axis of the conduit. In radio frequency mode, they can form an equivalent large surface area electrode, which reduces impedance and increases ablation depth. In pulse mode, they can form a regular and uniform electrode pair, which avoids electric field distortion and tip discharge, and improves the safety and controllability of pulse ablation.

[0076] The combined electrode 110 uses only two separate electrodes to achieve dual-mode functionality. Its simple structure and clear layout reduce the complexity of the distal end of the catheter and facilitate the arrangement and fixation of components such as wires, infusion lines, and sensors, thereby improving product consistency and reliability.

[0077] In some embodiments, such as Figures 2-4As shown, the surface of the first pulsed discharge electrode 121 has several circumferential grooves 121-1, i.e., a cutting electrode form. The grooves 121-1 extend circumferentially along the first pulsed discharge electrode 121 and are spaced apart along the axial direction of the catheter. While ensuring the structural strength and electrical performance of the electrode, the cutting electrode can further improve its bending compliance, allowing the electrode to bend synchronously with the catheter body, avoiding poor contact due to excessive electrode rigidity, while not affecting the electrode's energy output and mapping function. The circumferential grooves 121-1 also make the surface contour of the first pulsed discharge electrode 121 smoother and the electric field distribution more uniform. In pulsed electric field ablation mode, this effectively suppresses tip discharge, reduces high-voltage pulse damage to the blood, lowers the risk of hemolysis, and improves surgical safety.

[0078] Furthermore, the transition areas of each surface of the first pulse discharge electrode 121 are rounded, meaning that the edges, corners, and steps of the electrode surface all adopt a smooth transition structure to avoid sharp corners, sharp edges, or abrupt changes. This makes the electric field distribution on the electrode surface more uniform, significantly reduces the electric field concentration effect during pulsed electric field ablation, effectively suppresses sharp discharge, and improves the stability of pulsed ablation. The smooth transition of the rounded corner structure can also reduce the stimulation and damage to blood cells under high-voltage pulses, further reducing the risk of hemolysis, while reducing local stimulation to tissues and improving surgical safety.

[0079] In some embodiments, the conduit has a bendable structure formed in the segment where the first pulse discharge electrode 121 is located. The bendable structure includes at least one of a tapering structure 320-3, a circumferential groove, a heat-treated low-stiffness region, and a low-strength dissimilar material region, used to reduce the bending stiffness of the segment and improve the flexibility and bending compliance of the distal end of the conduit. Figure 4 In the illustrated embodiment, the bendable structure is configured as a tapering structure 320-3. The outer wall of the catheter (body 320) is tapered or reduced in diameter, significantly reducing the bending stiffness in that area. This makes the distal end of the catheter more flexible and bendable, allowing for better contact with complex anatomical structures (such as the pulmonary vein orifice, auricle, etc.), effectively improving the quality of contact, reducing local suspension or poor contact, and enhancing the accuracy and reliability of ablation. The bending shape of the catheter at the first pulse discharge electrode 121 is as follows... Figure 5 As shown.

[0080] In some embodiments, to improve the flexibility and bending responsiveness of the first pulse discharge electrode 121, such as Figure 6As shown, the first pulse discharge electrode 121 adopts a spring-wound structure, formed by spirally winding an elastic wire 121-2 in the circumferential direction. The wire can be made of metal, such as a platinum-iridium alloy or a medical-grade titanium alloy, which are corrosion-resistant and biocompatible. The spring-wound structure itself has good elasticity and flexibility, and can bend and deform synchronously with the catheter body, greatly reducing the electrode rigidity. This makes the electrode easier to conform to complex anatomical curves, improves the contact quality, and avoids poor contact or tissue irritation caused by an overly rigid electrode.

[0081] Furthermore, the wire 121-2 forms a multi-turn spiral structure, and between turns, at least every other turn, the opposite sides of adjacent turns of wire are locally welded and fixed, with the length of each weld controlled within the range of 0.1 to 1 mm. This embodiment, through the method of "local spot welding at least every other turn," ensures the overall structural stability and circumferential integrity of the coiled electrode, preventing spring slippage, deformation, and displacement during use, while also maintaining sufficient bendable gaps to avoid loss of flexibility due to continuous welding throughout the circumference, thus achieving a balance between structural strength and bending performance. Controlling the welding length within the small range of 0.1 to 1 mm minimizes the heat-affected zone, avoids local material hardening and embrittlement, reduces the risk of fatigue fracture at the weld points during repeated bending of the conduit, and simultaneously reduces stress concentration, improving the electrode's service life and reliability.

[0082] Furthermore, the cross-sectional profile of the filament 121-2 is circular, or the cross-sectional edge includes rounded corners to avoid sharp edges, which can significantly alleviate electric field concentration and tip discharge under pulsed electric field, making the electric field distribution more uniform and reducing the risk of hemolysis and tissue damage; at the same time, the smooth profile can reduce mechanical scratching of blood vessels and the inner wall of the heart chamber, improving biocompatibility and operational safety.

[0083] In addition, the first pulse discharge electrode 121 is a spiral spring structure formed by elastic wire, which has good resilience and can effectively restore its shape after bending. This is beneficial for maintaining a stable electrode shape in complex anatomical environments, ensuring the consistency of the pulse discharge area, and improving the controllability and repeatability of ablation.

[0084] In some embodiments, such as Figure 4 As shown, to achieve efficient coolant discharge and ensure temperature control during the ablation process, this invention features a multi-port discharge structure. Specifically, the first electrode 111 has several first discharge ports a, the second electrode 112 has several second discharge ports b, and the conduit has several third discharge ports c, all connected to the flow-through structure of the first pulse discharge electrode 121 (including the groove 121-1 of the annular cut electrode and the spiral gap of the coiled electrode). The discharge ports work together to discharge coolant, forming a comprehensive, multi-regional cooling system.

[0085] The first discharge port a and the second discharge port b correspond to the two electrode components of the combined electrode 110, respectively, and the third discharge port c corresponds to the groove 121-1 area of ​​the first pulse discharge electrode 121. This achieves full-coverage cooling of all ablation electrodes and key areas, which can effectively reduce the temperature rise at the electrode-tissue interface, significantly reduce the risk of tissue rupture (POP) during radiofrequency ablation, and at the same time avoid performance degradation of the electrode due to overheating, ensuring the stability of energy output.

[0086] The third discharge port c is connected to the groove 121-1 of the first pulse discharge electrode 121. The groove 121-1 can play a guiding role, so that the coolant can evenly cover the electrode surface and be discharged quickly, avoiding local accumulation or poor flow of coolant, and further improving cooling efficiency. At the same time, the multiple discharge ports are distributed in a dispersed manner, which can make the coolant distribution more uniform, ensure that the temperature of each ablation area is consistent, and improve the stability of the ablation effect.

[0087] In some embodiments, the catheter further includes at least one mapping electrode for acquiring electrocardiogram signals and mapping tissue potentials. The mapping electrode can acquire potential signals of the target tissue in real time, enabling pre-ablation mapping, monitoring during ablation, and post-ablation verification, helping the operator accurately identify abnormal potential areas, improving the accuracy of ablation target localization, and enhancing the effectiveness of the procedure.

[0088] Furthermore, when two or more mapping electrodes are provided, the mapping electrodes are spaced apart along the axial direction of the conduit to achieve multi-point synchronous mapping. For example... Figure 2 As shown, the mapping electrode may include a fourth electrode 201 and a fifth electrode 202. The mapping electrode can be flush with the tube structure of the catheter, making the outer surface of the catheter smooth and continuous, significantly improving the catheter's pushability, passage and flexibility in blood vessels and heart chambers, and reducing scratch damage to the inner wall of blood vessels or myocardial tissue.

[0089] In some embodiments, such as Figure 7 As shown, the catheter includes a tube body 320 and an adapter 310. The adapter 310 is connected to the distal end of the tube body 320 and is used to assemble, seal, and transition the distal end structure of the catheter.

[0090] like Figure 8 As shown, the tube body 320 includes a dual-cavity section 321, and the first pulse discharge electrode 121 and the calibration electrode are both located in the dual-cavity section 321.

[0091] like Figure 9As shown, one cavity of the dual-cavity section 321 (such as the dual-cavity coolant pipe cavity 321-2) is used to pass through or form a coolant pipe, while the other cavity (such as the dual-cavity wire pipe cavity 321-1) is used to pass through the wires of each electrode. The dual-cavity structure provides a fixed and orderly channel for the coolant pipe and wires, avoiding entanglement, compression, and wear between the wires and pipes, facilitating the installation and assembly of internal components, and improving production efficiency and product consistency.

[0092] In some embodiments, such as Figure 7 As shown, the bonding portion of the first electrode 111 has an enlarged diameter structure 111-1. This enlarged diameter structure 111-1 can be seen as an enlarged hole in the proximal inner wall of the first electrode 111, which can increase the bonding contact area, making the bonding stronger and the adhesion more powerful. It is understood that the first electrode 111 still maintains a certain wall thickness based on this enlarged diameter structure 111-1 to ensure sufficient strength.

[0093] In some embodiments, the annular portion of the adapter 310 for bonding with the first electrode 111 has a concave-convex structure that increases the surface area. This concave-convex structure refers to the ability to create grooves or protrusions on the annular surface of the adapter 310. Compared to a regular annular surface, either grooves or protrusions increase the adhesive contact area. Figure 10 The adhesive reservoir 311-1 shown is designed to hold more adhesive, resulting in a stronger bond. This effectively reduces the risk of electrode detachment or loosening during conduit bending and twisting, improving structural reliability and service life. Furthermore, multiple adhesive reservoirs 311-1 are evenly distributed, ensuring more uniform bonding, reducing localized stress concentration, and enhancing the overall strength of the distal structure.

[0094] In some embodiments, such as Figure 7 and Figure 10 As shown, the adapter 310 is made of insulating rigid material, such as ceramic. Ceramic has excellent insulation performance, high structural strength, good biocompatibility, and will not interfere with the electric field and energy output.

[0095] In some embodiments, the first electrode 111 is bonded to the distal end of the adapter 310; the second electrode 112 is pressed against the outer periphery of the adapter 310; the insulating pad 113 is bonded to the adapter 310, and its two axial sides are adjacent to the first electrode 111 and the second electrode 112, respectively.

[0096] Furthermore, a first annular groove 312 is formed at the location where the insulating pad 113 is installed in the adapter 310, and a second annular groove 314 is formed at the location where the second electrode 112 is installed; this allows for further weight reduction of the adapter 310 while ensuring installation strength. The first annular groove 312 also allows for precise positioning, circumferential limiting, and axial fixation of the insulating pad 113, preventing assembly misalignment, rotation, or displacement. The second annular groove 314 also allows for uniform distribution of coolant to the second electrode 112, as the side hole of the adapter 310 is located in this location.

[0097] Furthermore, such as Figure 7 and Figure 10 As shown, the adapter 310 also has a first convex ring segment 311, a second convex ring segment 313, and a third convex ring segment 315. The first electrode 111 is fixedly connected to the outer peripheral surface of the first convex ring segment 311 by adhesive bonding, achieving a stable assembly between the first electrode 111 and the adapter 310. The second electrode 112 is fixed to the outer peripheral surfaces of both the second convex ring segment 313 and the third convex ring segment 315 by press-fitting. The cooperation of the two convex ring segments achieves precise positioning and firm fixation of the second electrode 112, which, together with the first electrode 111 and the insulating gasket 113, constitutes a combined electrode 110 structure.

[0098] In some embodiments, such as Figure 7 and Figure 10 As shown, the first electrode 111 and the second electrode 112 have the same outer diameter, making the outer contour of the combined electrode 110 continuous and regular, facilitating stable contact with tissue and improving contact consistency. Furthermore, the outer surfaces of the first electrode 111 and the second electrode 112 protrude from the outer surface of the tube body 320, ensuring reliable contact between the electrodes and myocardial tissue and avoiding poor contact and increased impedance caused by obstruction from the tube body sidewalls. Further, the convex structure can further increase the effective discharge area, reduce contact impedance, and improve the radiofrequency ablation energy output and ablation depth.

[0099] In some embodiments, to achieve a stable connection and precise positioning between the tube body 320 and the adapter 310, such as Figure 7 and Figure 10As shown, a countersunk hole structure 320-1 is formed at the distal end of the tube body 320, and an enlarged diameter section 320-2 is integrally formed on the inner side of the countersunk hole structure 320-1. The inner diameter of the enlarged diameter section 320-2 is larger than other parts of the countersunk hole structure 320-1, which is used to achieve the snap-fit ​​fixation of the adapter 310. Correspondingly, a plug-in section 316 and a snap-fit ​​section 317 are formed at the proximal end of the adapter 310. The snap-fit ​​section 317 is located at the proximal end of the adapter 310, and its outer diameter is adapted to the inner diameter of the enlarged diameter section 320-2 at the distal end of the tube body 320. During assembly, the snap-fit ​​section 317 of the adapter 310 is installed in the enlarged diameter section 320-2 to form a hook-like connection. The plug-in section 316 fits against the inner wall of the countersunk hole structure 320-1 to achieve precise assembly and stable connection between the tube body 320 and the adapter 310. Optionally, since the material of the tube body 320 has a certain degree of elasticity and flexibility, even if the outer diameter of the snap-fit ​​section 317 is larger than the inner diameter of the countersunk structure 320-1, the snap-fit ​​section 317 can still enter the enlarged diameter section 320-2 through the countersunk structure 320-1 and form a stable connection.

[0100] In some embodiments, such as Figure 7 As shown, to achieve sealing protection, electric field optimization, and electrical safety between the electrode and the tube body 320, a semi-conductive adhesive e is provided near the proximal end of the second electrode 112 and at both ends of the first pulse discharge electrode 121 for sealing with the tube body 320. Since the outer diameters of the combined electrode 110 and the first pulse discharge electrode 121 are slightly larger than the outer diameter of the tube body 320, the semi-conductive adhesive e can transform the stepped transition between the corresponding electrode and the tube body 320 into a gradual transition, making the surface smoother. Optionally, the volume resistivity of the semi-conductive adhesive e is configured to be 10. 4 -10 10 The current is between Ω·m, which gives it moderate conductivity, so that it does not form a short circuit and can also play a role in buffering and transitioning the electric field.

[0101] Especially in pulsed electric field ablation mode, the semiconductive gel e can significantly suppress tip discharge, reduce the generation of bubbles during discharge, avoid problems such as hemolysis and tissue damage caused by electric field distortion, and at the same time ensure the stability of energy output in both radiofrequency and pulsed modes, thus improving the consistency of ablation effect.

[0102] In some embodiments, to achieve precise bending control of the distal end of the catheter and adapt to the fitting requirements of complex anatomical structures, the catheter includes a bending control component, such as... Figure 1 and Figure 12 As shown, the bending control assembly includes a bending control ring 410, a rigid adapter 420, a bending control wire 430, and a bending control handle 440, etc.; the tube body 320 has a bending control section 322, which is located on the side of the double-lumen section 321 near the proximal end, that is, between the double-lumen section 321 and the proximal operating end of the catheter, and is used to realize the bending action of the distal end of the catheter.

[0103] It should be noted that the section of tube 320 between its distal end and the bend control section 322 can be considered as the head end tube. The entire head end tube can change its orientation when the bend control section 322 is manipulated, so that the electrode can accurately attach to the target ablation site.

[0104] Furthermore, such as Figure 13 As shown, the bending control ring 410 is fixedly sleeved on the inner or outer wall of the bending control section 322 of the tube body 320 to enhance the structural strength of the bending control section 322 and ensure accurate transmission of bending action. The bending control ring 410 is fixedly connected to one end of the bending control wire 430 through the rigid adapter 420, and the other end of the bending control wire 430 is fixedly connected to the bending control handle 440; the operator can pull the bending control wire 430 by manipulating the bending control handle 440, thereby driving the bending control ring 410 and the bending control section 322 to achieve bending. Figure 1 As shown, optionally, the bending control handle 440 includes a handle body 441 and a handle core 442 that are sleeved or plugged into each other, wherein one of the handle body 441 and the handle core 442 is fixedly connected to the tube body 320, and the other is fixedly connected to the bending control screw 430.

[0105] Furthermore, the rigid adapter 420 is fixed within an eccentric cavity 322-3 within the bending control section 322. The rigid adapter 420 has a predetermined length along the axial direction of the conduit, causing the bending control ring 410 and the elastic and bendable bending control wire 430 to be offset axially, making the bending action easier. This design effectively avoids interference between the bending control wire 430 and the bending control ring 410 during the bending process, ensuring smooth and stable bending action, while reducing wear on the bending control wire 430 and extending the service life of the bending control assembly.

[0106] The bending control component enables precise bending control of the catheter tip. Operators can flexibly adjust the angle of the catheter tip by manipulating the bending control handle 440, allowing the electrode to accurately contact the target ablation site (such as the pulmonary vein orifice, atrial appendage, and other complex areas). This solves the problems of inaccurate bending and difficulty in contact with the target site of traditional catheters, improving ablation accuracy. At the same time, the bending control segment 322 is located at the proximal end of the dual-lumen segment 321, which does not affect the normal operation of the electrode, coolant pipeline, and lead wire, achieving synergistic adaptation between the bending control function and the ablation function.

[0107] As one possible approach, such as Figure 13As shown, the bending control section 322 can have four cavities: a four-cavity conductor conduit cavity 322-1, a four-cavity coolant conduit cavity 322-2, an eccentric cavity 322-3, and a spare cavity. The four-cavity conductor conduit cavity 322-1 is used to carry the conductors for each electrode; the four-cavity coolant conduit cavity 322-2 is used to transport coolant, working in conjunction with the coolant conduit of the dual-cavity section 321 to ensure smooth coolant flow; the eccentric cavity 322-3 is used to fix the rigid adapter 420, ensuring stable transmission of the bending control assembly; optionally, the spare cavity is also an eccentric cavity 322-3, which can be used to install another bending control assembly. Through the coordinated operation of the two bending control assemblies, bidirectional bending control of the distal end of the conduit can be achieved, further improving the bending flexibility and control precision of the conduit. The spare cavity can also be used to place a magnetic sensor, which can be connected to a three-dimensional mapping system to display the position of the catheter in the heart in real time. The magnetic sensor is axially mounted within the length of the rigid adapter 420. The rigid adapter 420 has high strength, so that the magnetic sensor will not bend with the bending of the control section 322, thus protecting the magnetic sensor.

[0108] In some embodiments, the pipe body 320 on the proximal side of the bending section 322 can be configured as a single-cavity section 323, in which coolant can be transported through a pipeline, which needs to be sealed to the four-cavity coolant cavity 322-2; while in the bending section 322 and the double-cavity section 321, the coolant cavity formed by the pipe body 320 can be used as a transport channel, without the need for additional pipelines.

[0109] In some embodiments, to achieve the temperature measurement function, such as Figure 7 As shown, the conduit also includes a thermal sensor 501 disposed within the first electrode 111 for real-time detection of the temperature of the ablation site or the first electrode 111. Optionally, depending on actual needs, the sensing part of the thermal sensor 501 is located on the distal plane, outer peripheral surface, or within the first electrode 111.

[0110] As at least one possible implementation, the thermal sensor 501 is disposed at the central hole 318 at the distal end of the first electrode 111. The thermal sensor 501 is encapsulated within the first electrode 111, with its end flush with the distal end plane of the first electrode 111, and is sealed and fixed by potting compound. Optionally, the potting compound here is a thermally conductive adhesive, which can ensure both the accuracy of temperature measurement by the thermal sensor and its strength, providing a seal. The thermal sensor 501 can collect the tissue interface temperature in real time and accurately, avoiding tissue bursting or carbonization due to overheating, or insufficient ablation due to insufficient temperature. The end of the thermal sensor 501 is flush with the distal end plane of the first electrode 111, which does not affect electrode contact and will not cause electric field concentration or tip discharge, thus balancing temperature measurement and ablation performance. It is understood that the term "flush" here means that the end of the thermal sensor 501 does not exceed the distal end plane of the first electrode 111, but the potting compound can be slightly raised smoothly. The use of potting compound for sealing and fixation can prevent coolant and blood from seeping in, protect the thermal sensor 501, and at the same time improve structural strength and withstand the bending and torsion of the conduit.

[0111] In some embodiments, the thermal sensor 501 is encapsulated within the first electrode 111 by a thermal insulation structure to isolate it from the coolant. The thermal insulation structure effectively blocks the interference of the coolant's coldness, allowing the thermal sensor 501 to more accurately reflect the tissue ablation temperature rather than the coolant temperature, thus significantly improving temperature measurement accuracy.

[0112] As at least one possible way, such as Figure 7 and Figure 15 As shown, the heat insulation structure includes an outer PI tube 502 and an inner PI tube 503. A gap is formed between the annular walls of the outer PI tube 502 and the inner PI tube 503. This gap can serve as an air insulation layer, providing strong heat insulation, a flexible structure, and without increasing electrode rigidity or affecting the flexibility of the conduit. The distal end of the outer PI tube 502 is unfolded 502-1 and bonded to the inner wall plane of the end of the first electrode 111. This provides a large bonding area and strong adhesion, maintaining stability even under high temperature and bending conditions, thus improving product reliability.

[0113] In some embodiments, to optimize the energy output efficiency in radiofrequency ablation mode, the first electrode 111 and the second electrode 112 are configured in parallel. This parallel configuration enables the two electrodes to form a synergistic discharge structure with the same potential and phase in radiofrequency mode, jointly serving as the radiofrequency energy output terminal. This ensures the stability and consistency of energy output while further reducing the contact impedance between the electrodes and the tissue, thereby improving energy output efficiency.

[0114] In some embodiments, such as Figure 16As shown, to achieve electrical signal and energy transmission between each electrode and external energy and control devices, each electrode of the conduit is connected to the cable connector 6 via a corresponding wire. Specifically, the first electrode 111 is connected to the cable connector 6 via a first wire 610, with the distal end of the first wire 610 connected to the inner circumferential or end inner wall of the first electrode 111 to ensure the stability and conductivity of the connection; the second electrode 112 is connected to the cable connector 6 via a second wire 620, with the distal end of the second wire 620 connected to the inner circumferential wall of the second electrode 112; and the first pulse discharge electrode 121 is connected to the cable connector 6 via a third wire 630, with the distal end of the third wire 630 connected to the inner circumferential wall of the first pulse discharge electrode 121.

[0115] The proximal ends of each wire extend to the proximal end of the conduit and connect to the corresponding terminals of the cable connector 6. The cable connector 6 is used to connect to an external energy generator (RF / pulse) and control equipment. Each wire is arranged independently and does not interfere with each other, and is respectively used to transmit the electrical signals and ablation energy of each electrode.

[0116] Optionally, to further improve the reliability and safety of the first conductor 610 connection, the first conductor 610 includes a safety wire. One end of the safety wire is welded to the first electrode 111 to achieve a stable electrical connection with the first electrode 111. The other end of the safety wire, or the middle section of the first conductor 610, is fixed to the bending control ring 410. The bending control ring 410 provides auxiliary fixation and limiting for the safety wire and the first conductor 610, and can also further prevent the distal electrode from falling off. In addition, the safety wire can also be bonded to the outer PI tube 502 to further enhance the fixing effect of the safety wire and prevent it from shifting or shaking.

[0117] In addition, the adapter 310 also has a wire side hole 319-2 for the passage of the second wire 620.

[0118] Optionally, from the distal end to the proximal end, after the first conductor 610, the second conductor 620 and the third conductor 630 exit the double-cavity conductor tube 321-1 of the double-cavity section 321, they can pass through the bending control ring 410 and then enter the four-cavity conductor tube 322-1 to achieve a fixed connection between the first conductor 610, the second conductor 620 and the third conductor 630.

[0119] In some embodiments, to achieve smooth delivery and discharge of coolant, the adapter 310 is provided with a through-flow channel structure: such as... Figure 16As shown, the adapter 310 has a central hole 318 extending along its axial direction, and also has a side hole. This side hole connects the central hole 318 with the second discharge port b (located on the second electrode 112), forming a complete coolant flow path. This allows the coolant in the central hole 318 to smoothly enter the second discharge port b through the side hole and ultimately discharge to the electrode surface, achieving cooling of the second electrode 112 and the ablation area. The side hole mentioned here refers to… Figure 16 The flow-through side hole 319-1 in the middle.

[0120] In the above embodiment, the flow-through side hole 319-1 connects the central hole 318 and the second discharge port b, eliminating the need for additional connecting pipes, reducing coolant flow resistance, and allowing coolant to be discharged quickly and evenly through the second discharge port b, thus improving cooling efficiency. Simultaneously, the flow channel structure is integrated into the adapter 310, occupying no extra space, making the distal end of the conduit more compact, and not increasing the outer diameter of the conduit. Both the central hole 318 and the side hole are directly formed into the adapter 310, integrally molded with it, resulting in high structural strength and good sealing performance, effectively preventing coolant leakage, reducing the number of parts, simplifying the assembly process, reducing assembly errors, and improving product consistency and reliability. Furthermore, the flow channel structure does not interfere with the wire arrangement and electrode function, achieving synergistic adaptation between the cooling function and other functions.

[0121] In some embodiments, to optimize the discharge efficiency of the coolant and ensure uniform cooling at each discharge port, the cross-sectional areas of the coolant pipe and each discharge port are precisely designed: the minimum flow cross-sectional area of ​​the main pipe section upstream of the third discharge port is A, the sum of the cross-sectional areas of all first discharge ports a of the first electrode 111 is m, the sum of the cross-sectional areas of all second discharge ports b of the second electrode 112 is n, and the sum of the cross-sectional areas of all third discharge ports of the first pulse discharge electrode 121 is p, satisfying: A≥m+n+p, and / or, m=n, and / or, p<1 / 3(m+n+p).

[0122] Among them, the minimum cross-sectional area of ​​the main pipe section, A≥m+n+p, can ensure that the conveying capacity of the coolant pipeline is not less than the total discharge capacity of all outlets, avoid coolant accumulation in the pipeline and reduction of flow velocity, and ensure the timeliness and uniformity of cooling.

[0123] The total area m of the first discharge port a is equal to the total area n of the second discharge port b (m=n), which ensures that the coolant discharge of the first electrode 111 and the second electrode 112 is consistent, thus ensuring that the cooling effect of the two electrodes is balanced and avoiding local overheating or differences in ablation effect caused by uneven cooling.

[0124] The total area p of the third discharge port c is less than one-third of (m+n+p) (p < 1 / 3 (m+n+p)), which allows for a reasonable allocation of coolant discharge from each discharge port. This ensures that the coolant is primarily concentrated on the first electrode 111 and the second electrode 112 (combined ablation electrodes), meeting the cooling requirements of their main ablation function while also providing basic cooling for the first pulse discharge electrode 121, thus avoiding waste of cooling resources. Through this cross-sectional area allocation, preferential flow of coolant at the first pulse discharge electrode 121 can be suppressed, preventing maximum loss at the first pulse discharge electrode 121 and thus avoiding insufficient or no water output from the first and second electrodes 112. This improves the balance and stability of multi-electrode injection.

[0125] As an example, the first electrode 111 may be provided with 6 first discharge ports a, the second electrode 112 may be provided with 6 second discharge ports b, and the dual-cavity section 321 of the tube body 320 may be provided with 3 third discharge ports c (see Figure 9 (In the middle), the locations of the emission outlets are evenly distributed circumferentially. The number and location of each emission outlet can be determined according to the actual situation.

[0126] The coolant used in this invention is preferably a medical coolant (such as physiological saline or a special medical infusion solution) with good biocompatibility, non-irritation, and conductivity suitable for ablation requirements. Its physicochemical properties are stable, it will not damage human tissue, nor will it interfere with the energy output and electrical signal conduction of the electrode. It also possesses good heat dissipation performance, quickly removing the heat generated during ablation. The core functions of the coolant are: first, to reduce the surface temperature of the ablation electrode, preventing tissue carbonization and pop-up (POP) caused by overheating during radiofrequency ablation, and preventing electrode performance degradation due to high temperatures; second, to optimize the contact environment between the electrode and tissue, helping to stabilize contact impedance and ensure uniform energy output; third, in pulsed electric field ablation mode, it can help optimize the electric field distribution, further reducing the risk of hemolysis and improving surgical safety; and fourth, to provide a certain degree of cleaning effect on the electrode surface, reducing the possibility of thrombus formation.

[0127] In some embodiments, such as Figure 1As shown, the proximal end of the conduit is also provided with a Luer connector 7 that communicates with the coolant pipeline. The external infusion device delivers coolant to the inlet of the Luer connector 7 at the proximal end of the conduit. The coolant flows sequentially through the four-section coolant pipeline 322-2 and the two-section coolant pipeline 321-2 of the tube body 320, and enters the central hole 318 of the adapter 310. A portion of the coolant enters the second discharge port of the second electrode 112 through the flow-through side hole 319-1 of the adapter 310 and is discharged to the surface of the second electrode 112. A portion of the coolant flows through the corresponding channel inside the first electrode 111 and is discharged to the surface of the first electrode 111 through the first discharge port a of the first electrode 111. Another portion of the coolant flows through the groove 121-1 of the first pulse discharge electrode 121 through the third discharge port on the conduit and is discharged to the surface of the first pulse discharge electrode 121. Finally, comprehensive cooling of all ablation electrodes and ablation areas is achieved, and the cooled coolant is discharged from the body along with the body fluid.

[0128] The dual-energy discharge ablation catheter provided in this embodiment of the invention, through the synergistic design of its structure and energy channels, enables the catheter to employ an optimal energy output structure matching the corresponding energy form in both radiofrequency ablation and pulsed electric field ablation (PFA) operating modes, achieving efficient and stable energy release. Simultaneously, the catheter exhibits superior tissue adhesion in both ablation modes and can perform saline irrigation / rinsing on all electrodes involved in the discharge, reducing the risk of tissue rupture (POP) caused by excessive temperature rise at the electrode-tissue interface. Furthermore, saline irrigation improves the electric field and current distribution around the electrodes, reducing the risk of hemolysis caused by high voltage during PFA ablation, and enhancing the safety and controllability of the ablation process.

[0129] In this invention, features described and / or illustrated for one embodiment may be used in the same or similar manner in one or more other embodiments, and / or combined with or in place of features of other embodiments.

[0130] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, various modifications and variations of the embodiments of the present invention are possible. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A dual-energy discharge ablation catheter, characterized in that, An energy output electrode assembly (1) is formed at the distal end of the catheter. The energy output electrode assembly (1) includes at least a combined electrode (110) and a first pulse discharge electrode (121). The combined electrode (110) is located at the distal end of the catheter. The first pulse discharge electrode (121) and the combined electrode (110) are coaxially arranged on the catheter with a gap and are located on the proximal side of the combined electrode (110). The catheter is configured as follows: In radiofrequency ablation mode, discharge is performed by at least a portion of the combined electrode (110); in pulsed electric field ablation mode, a second pulsed discharge electrode is formed by the combined electrode (110), wherein the polarity of the first pulsed discharge electrode (121) is opposite to that of the second pulsed discharge electrode. The combined electrode (110) includes two or more electrode components, each of which is arranged at intervals along the axial direction of the conduit, and adjacent electrode components are separated by an insulating structure; the insulating structure includes an insulating pad (113), and each electrode component is connected to a cable connector (6) at the proximal end of the conduit by its own wire, so that each electrode component is isolated from each other and can measure its own contact resistance independently.

2. The dual-energy discharge ablation catheter according to claim 1, characterized in that, Each of the electrode segments is a ring electrode, or the electrode segment located at the farthest end is a cap-shaped electrode, and the remaining electrode segments are ring electrodes.

3. The dual-energy discharge ablation catheter according to claim 1, characterized in that, The combined electrode (110) includes two electrode components, namely a first electrode (111) and a second electrode (112), wherein the first electrode (111) is located at the farthest end of the conduit and the length of the first electrode (111) is shorter than that of the second electrode (112).

4. The dual-energy discharge ablation catheter according to claim 3, characterized in that, The surface of the first pulse discharge electrode (121) has a plurality of circumferential grooves (121-1). The conduit has a bendable structure in the section where the first pulse discharge electrode (121) is located. The bendable structure includes at least one of the following: a tapering structure (320-3), a circumferential groove, a heat-treated low-stiffness region, and a low-strength dissimilar material region.

5. The dual-energy discharge ablation catheter according to claim 3, characterized in that, The first pulse discharge electrode (121) is a spring-wound structure, formed by spirally winding elastic wire; The wire has multiple turns, with at least one turn between each other. Two adjacent turns of wire are welded and fixed on opposite sides along their axial direction, with a weld length of 0.1~1mm. The cross-sectional profile of the filament is circular or includes rounded corners.

6. The dual-energy discharge ablation catheter according to claim 3 or 4, characterized in that, A plurality of first discharge ports (a) are formed on the first electrode (111); A plurality of second discharge ports (b) are formed on the second electrode (112); The conduit has several third discharge ports (c) formed on it and is connected to the overcurrent structure of the first pulse discharge electrode (121); Each outlet is used to discharge coolant.

7. The dual-energy discharge ablation catheter according to claim 6, characterized in that, The catheter also includes at least one mapping electrode; when there are two or more mapping electrodes, the mapping electrodes are spaced apart along the axial direction of the catheter.

8. The dual-energy discharge ablation catheter according to claim 7, characterized in that, The catheter includes a tube body (320) and an adapter (310), the adapter (310) being connected to the distal end of the tube body (320); The tube body (320) includes a dual-cavity section (321), where the first pulse discharge electrode (121) and the calibration electrode are both located in the dual-cavity section (321). One cavity of the dual-cavity section (321) is used to pass through or form a coolant pipe, and the other cavity is used to pass through the wires of each electrode.

9. The dual-energy discharge ablation catheter according to claim 8, characterized in that, The catheter includes a bending control assembly, which includes a bending control ring (410), a rigid adapter (420), a bending control wire (430), and a bending control handle (440); the tube body (320) has a bending control section (322) located on the proximal side of the dual-lumen section (321); The bending control ring (410) is fixedly sleeved on the inner or outer wall of the bending control section (322) of the tube body (320). The bending control ring (410) is fixedly connected to one end of the bending control wire (430) through the rigid adapter (420). The other end of the bending control wire (430) is fixedly connected to the bending control handle (440). The rigid adapter (420) is fixed in an eccentric cavity (322-3) within the bending control section (322). The rigid adapter (420) has a set length along the axial direction of the conduit, such that the bending control ring (410) is offset from the bending control wire (430) which is elastic and bendable in the axial direction.

10. The dual-energy discharge ablation catheter according to claim 8, characterized in that, The first electrode (111) is bonded to the distal end of the adapter (310); The second electrode (112) is pressed against the outer periphery of the adapter (310); The insulating pad (113) is bonded to the adapter (310), and its two sides in the axial direction are adjacent to the first electrode (111) and the second electrode (112) respectively.

11. The dual-energy discharge ablation catheter according to claim 10, characterized in that, The bonding portion of the first electrode (111) has an expanded diameter structure (111-1); and / or, The annular portion of the adapter (310) for bonding with the first electrode (111) has an uneven structure that increases the surface area; and / or, The adapter (310) is made of an insulating rigid material, and a first annular groove (312) is formed at the location where the insulating pad (113) is installed, and a second annular groove (314) is formed at the location where the second electrode (112) is installed; and / or, The first electrode (111) and the second electrode (112) have the same outer diameter, and the outer surfaces of the first electrode (111) and the second electrode (112) protrude from the outer surface of the tube body (320).

12. The dual-energy discharge ablation catheter according to claim 11, characterized in that, At the proximal end of the second electrode (112) and at both ends of the first pulse discharge electrode (121), a semiconductive adhesive (e) for sealing with the tube body (320) is provided, the volume resistivity of which is configured to be 10. 4 -10 10 Between Ω·m.

13. The dual-energy discharge ablation catheter according to claim 8, characterized in that, The distal end of the tube body (320) has a countersunk structure (320-1) and an enlarged diameter section (320-2) is formed inside the countersunk structure (320-1). The proximal end of the adapter (310) has a plug section (316) and a snap-fit ​​section (317) located at the proximal end. The snap-fit ​​section (317) is installed on the enlarged diameter section (320-2).

14. The dual-energy discharge ablation catheter according to claim 8, characterized in that, The first electrode (111) and the second electrode (112) are configured to be connected in parallel; and / or, The width of the insulating pad (113) is configured to be 0.1~1mm.

15. The dual-energy discharge ablation catheter according to claim 9, characterized in that, The first electrode (111) is connected to the cable connector (6) via a first wire (610), the distal end of which is connected to the circumferential inner wall or end inner wall of the first electrode (111); the second electrode (112) is connected to the cable connector (6) via a second wire (620), the distal end of which is connected to the circumferential inner wall of the second electrode (112); the first pulse discharge electrode (121) is connected to the cable connector (6) via a third wire (630), the distal end of which is connected to the circumferential inner wall of the first pulse discharge electrode (121).

16. The dual-energy discharge ablation catheter according to claim 15, characterized in that, The first conductor (610) includes a safety wire, one end of which is welded to the first electrode (111), and the other end of the safety wire or the middle section of the first conductor (610) is fixed to the bending control ring (410).

17. The dual-energy discharge ablation catheter according to claim 3, characterized in that, The conduit also includes a thermal sensor (501) disposed in the first electrode (111), wherein the sensing part of the thermal sensor (501) is located on the distal plane, outer peripheral surface or inside the first electrode (111).

18. The dual-energy discharge ablation catheter according to claim 17, characterized in that, The thermal sensor (501) is located at the center hole (318) of the distal end of the first electrode (111). The thermal sensor (501) is encapsulated inside the first electrode (111), with its end flush with the plane of the distal end of the first electrode (111) and sealed and fixed by potting compound.

19. The dual-energy discharge ablation catheter according to claim 18, characterized in that, The thermal sensor (501) is encapsulated within the first electrode (111) by a thermal insulation structure to isolate it from the coolant.

20. The dual-energy discharge ablation catheter according to claim 19, characterized in that, The heat insulation structure includes an outer PI tube (502) and an inner PI tube (503), with a gap formed between the annular tube walls of the outer PI tube (502) and the inner PI tube (503); the distal end of the outer PI tube (502) is unfolded (502-1) and bonded to the inner end wall plane of the first electrode (111).

21. The dual-energy discharge ablation catheter according to claim 8, characterized in that, The adapter (310) has a central hole (318) extending through it along its axial direction and a side hole that connects the central hole (318) and the second discharge port (b), allowing coolant in the central hole (318) to enter the second discharge port (b) through the side hole.

22. The dual-energy discharge ablation catheter according to claim 8, characterized in that, The minimum cross-sectional area of ​​the main pipe upstream of the third discharge port of the coolant pipe is A, the sum of the cross-sectional areas of all the first discharge ports (a) of the first electrode (111) is m, the sum of the cross-sectional areas of all the second discharge ports (b) of the second electrode (112) is n, and the sum of the cross-sectional areas of all the third discharge ports (c) of the first pulse discharge electrode (121) is p, satisfying: A≥m+n+p, and / or, m=n, and / or, p < 1 / 3 (m + n + p).

23. The dual-energy discharge ablation catheter according to claim 21, characterized in that, The proximal end of the conduit is also provided with a Luer connector (7) that communicates with the coolant pipe.

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