Pulse ablation device

Abstract

The application discloses a kind of pulse ablation devices, comprising: outer tube and the inner tube of the ablation catheter of being set in the outer tube and being axially movable relative to the outer tube;Electrode assembly is arranged between the outer tube and inner tube, each electrode element in electrode assembly includes proximal end structure fixed to the distal end of the outer tube, distal end structure fixed to the distal end of the inner tube, and connecting rod structure is connected between the proximal end structure and distal end structure;Wherein, the inner tube is provided with buffer structure;The application utilizes the buffer structure for slowing down the expansion speed of electrode assembly when electrode assembly is converted from the shrinkage state to the expansion state on the inner tube, effectively solves the problem that human body tissue is easily damaged when electrode ball expands too fast or too large due to the force of pulling the inner tube being too large or too fast.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, and particularly relates to a pulse ablation device for a pulse ablation system. BACKGROUND

[0002] In the field of electrophysiological therapy, it is a common means to deliver energy and perform tissue ablation by using an ablation catheter. After the ablation catheter head (distal end) is inserted into the heart to reach the corresponding treatment target position, the energy medium (such as radio frequency, ultrasound, pulse, etc.) is sent from the energy platform connected to the tail end (proximal end) of the ablation catheter to the energy delivery electrode on the head end of the ablation catheter, and the electrode transmits the energy to the tissue after being in close contact with the tissue, so as to ablate the tissue.

[0003] The current stage commonly used ablation methods include radio frequency, ultrasound or freezing, etc. These ablation methods have certain advantages, but also have corresponding limitations, for example, the ablation energy lacks selectivity in damaging the tissue in the ablation area, and depends on the ablation force of the catheter, which may cause damage to the adjacent esophagus, coronary artery and phrenic nerve, etc. Therefore, exploring a safe and efficient ablation method to achieve persistent pulmonary vein isolation without damaging the adjacent tissue is a recent research hotspot in the industry. In addition to the application of pressure sensing and precise and safe radio frequency ablation according to the ablation index (AI) or the damage index (LSI), the new HPSD ablation method in the last two years also shows its high efficiency and safety, that is, the pulse field ablation (PFA) technology. Especially since the initial application of the new pulse field non-thermal energy energy shows better clinical effect, various researches around the PFA product have been increasing.

[0004] The common pulse electric field ablation catheter currently adopts a conventional ring electrode, such as arranging electrode pieces on a ring carrier to approach the tissue to be ablated, for example, the pulmonary vein part. The structure of the ring electrode is simple, but in actual ablation surgery, the expansion degree of the ring structure is not easy to adjust, or higher level operation requirements are put forward to the doctor, and the ideal ablation effect cannot be achieved. In addition, a strip-shaped basket electrode is arranged at the distal end of the ablation catheter to make up for the defects of the ring electrode, but the strip-shaped basket electrodes are not connected to each other, although they are easy to retract, but the adjacent electrodes often mis-touch in operation. In addition, the industry also proposes a mesh structure of the basket electrode. Although the mesh structure of the basket electrode is stable, when the basket electrode is released from the catheter of the delivery device during the operation, the electrode ball expands too fast or too large, which is easy to harm the human body tissue. Or after the operation, when it is retracted into the catheter, the force of the inner tube is too large or too fast, which causes the electrode to be difficult to be retracted into the catheter of the delivery device. Therefore, how to propose an inner tube structure which can reduce the difficulty of the operator's force control has become a technical problem to be solved in the field. SUMMARY

[0005] In view of the above-mentioned shortcomings of the related art, the purpose of the present application is to provide a pulse ablation device to solve the technical problems that the electrode ball expands too fast or too large when the basket electrode is released from the catheter of the delivery device during the operation, which is easy to harm the human body tissue; and when it is retracted into the catheter after the operation, the force of the inner tube is too large or too fast, which causes the electrode to be difficult to be retracted into the catheter of the delivery device.

[0006] To achieve the above-mentioned purpose and other related purposes, the present application discloses a pulse ablation device, comprising: an ablation catheter, an outer tube extending from a proximal end to a distal end, and an inner tube arranged in the outer tube and capable of moving axially relative to the outer tube; wherein the inner tube is provided with a buffer structure; an electrode assembly, a plurality of electrode elements arranged between the outer tube and the inner tube, each electrode element comprising a proximal end structure fixed to the distal end of the outer tube, a distal end structure fixed to the distal end of the inner tube, and a connecting rod structure connected between the proximal end structure and the distal end structure; wherein the buffer structure of the inner tube slows down the expansion speed of the electrode assembly when the electrode assembly is converted from a retracted state to an expanded state.

[0007] In an embodiment of the present application, when the inner tube moves towards the proximal end direction relative to the outer tube, the initial speed of the proximal end part of the inner tube is greater than the initial speed of the distal end part of the inner tube.

[0008] In an embodiment of the present application, the buffer structure is an axial elastic structure or an axial elastic material integrally formed on the inner tube.

[0009] In an embodiment of the present application, the axial elastic structure is a spring structure.

[0010] In an embodiment of the present application, the buffer structure is integrally formed in a section of the inner tube corresponding to the proximal end to the distal end of the electrode assembly, in a middle section of the inner tube, or in a section adjacent to the proximal end of the inner tube.

[0011] In an embodiment of the present application, the inner tube comprises a smooth section for being arranged in the outer tube and extending from the proximal end of the outer tube towards the distal end of the outer tube to a distal end portion of the outer tube, a fixing section protruding from the distal end of the outer tube for fixing the distal end of the electrode assembly, and a buffer structure formed between the smooth section and the fixing section.

[0012] In an embodiment of the present application, the fixing section is provided with a limiting structure for limiting displacement of the distal end of the electrode assembly relative to the inner tube.

[0013] In an embodiment of the present application, the buffer structure is a spring structure with a decreasing tube diameter from the proximal end towards the distal end.

[0014] In an embodiment of the present application, the inner tube is a tube body with a decreasing tube diameter from the proximal end towards the distal end.

[0015] In an embodiment of the present application, the buffer structure is a compression spring arranged on a section of the inner tube corresponding to the proximal end to the distal end of the electrode assembly.

[0016] In an embodiment of the present application, the electrode assembly comprises a plurality of electrode elements, each electrode element comprising a proximal double-bar structure fixed to the distal end of the outer tube, a distal double-bar structure fixed to the distal end of the inner tube, and a single-bar structure connected between the proximal double-bar structure and the distal double-bar structure.

[0017] In an embodiment of the present application, the single-bar structure of each electrode element of the plurality of electrode elements provides a contraction traction force when the electrode assembly is converted from an expanded state to a contracted state, and provides an expansion biasing force when the electrode assembly is converted from a contracted state to an expanded state.

[0018] In an embodiment of the present application, the proximal double-bar structure comprises a proximal limiting bar, and a first proximal bar and a second proximal bar bifurcated from the proximal limiting bar and symmetric to each other; and the distal double-bar structure comprises a distal limiting bar, and a first distal bar and a second distal bar bifurcated from the distal limiting bar and symmetric to each other.

[0019] In an embodiment of the present application, the distal end of the first proximal rod in one of the plurality of electrode elements is coupled to the distal end of the second proximal rod in another electrode element on its first side; the distal end of the second proximal rod in the electrode element is coupled to the distal end of the first proximal rod in another electrode element on its second side.

[0020] In an embodiment of the present application, the proximal end of the first distal rod in one of the plurality of electrode elements is coupled to the proximal end of the second distal rod in another electrode element on its first side; the proximal end of the second distal rod in the electrode element is coupled to the proximal end of the first distal rod in another electrode element on its second side.

[0021] In an embodiment of the present application, the proximal end of the single rod structure in one of the plurality of electrode elements is coupled to the distal end of the second proximal rod in another electrode element on its first side; the distal end is coupled to the proximal end of the first proximal rod in another electrode element on its second side.

[0022] In an embodiment of the present application, the electrode assembly comprises a plurality of electrode elements, each electrode element comprising a forward branch structure fixed to the distal end of the outer tube and a reverse branch structure fixed to the distal end of the inner tube, and at least one link structure coupled between the forward branch structure and the reverse branch structure; wherein the inner tube is axially moved relative to the outer tube to drive the electrode assembly to switch between a contracted state and an expanded state.

[0023] In an embodiment of the present application, the forward branch structure and the reverse branch structure of each of the plurality of electrode elements are moved relative to each other to switch the ablation electrode element between a contracted state and an expanded state, the at least one link structure provides a contraction traction force to the forward branch structure and the reverse branch structure in the contracted state or provides an expansion support force to the forward branch structure and the reverse branch structure in the expanded state.

[0024] In an embodiment of the present application, the forward branch structure of each electrode element comprises a proximal stop rod, and a first proximal rod and a second proximal rod symmetrically diverging forwardly from the proximal stop rod, a third proximal rod and a fifth proximal rod symmetrically diverging forwardly from the first proximal rod, and a fourth proximal rod and a sixth proximal rod symmetrically diverging forwardly from the second proximal rod; wherein the fifth proximal rod and the sixth proximal rod are coupled at a junction.

[0025] In an embodiment of the present application, the reverse branch structure of each electrode element comprises a distal end limiting rod, and a first distal end rod and a second distal end rod reversely branched from the distal end limiting rod and symmetric to each other, a third distal end rod and a fifth distal end rod reversely branched from the first distal end rod and symmetric to each other, and a fourth distal end rod and a sixth distal end rod reversely branched from the second distal end rod and symmetric to each other; wherein the fifth distal end rod and the sixth distal end rod are connected at a junction.

[0026] In an embodiment of the present application, the distal end of the third proximal end rod and / or the proximal end of the third distal end rod in one of the electrode elements has a connecting ring for connecting another ablation electrode element; and the distal end of the fourth proximal end rod and / or the proximal end of the fourth distal end rod has a connecting ring for connecting yet another ablation electrode element.

[0027] In an embodiment of the present application, a plurality of insulating members are further included for electrically insulating the connection between two different electrode elements.

[0028] In an embodiment of the present application, the insulating member comprises an insulating pin, an insulating pin, or an insulating gasket.

[0029] In an embodiment of the present application, the expansion degree of the electrode assembly in the expanded state determines the contact degree of each electrode element with the tissue.

[0030] In an embodiment of the present application, at least one measuring element is arranged on the proximal end structure, the distal end structure, or the connecting rod structure of at least one electrode element in the electrode assembly.

[0031] In an embodiment of the present application, at least one measuring element is arranged between at least two adjacent electrode elements in the electrode assembly.

[0032] In an embodiment of the present application, the measuring element comprises one of a temperature sensor, an impedance sensor, a positioning / position sensor, or an attitude sensor.

[0033] In an embodiment of the present application, a guide wire is further included which can be arranged in the inner tube.

[0034] In an embodiment of the present application, a proximal end fixing ring is further included which is arranged in the lumen of the distal end of the outer tube for fixing the proximal end structure of the electrode assembly, and a plurality of proximal end limiting portions corresponding to each electrode element are uniformly arranged on the ring body of the proximal end fixing ring, each proximal end limiting portion having a proximal end clamping groove for clamping the proximal end structure.

[0035] In an embodiment of the present application, a coating layer for fixing the electrode assembly is wrapped on the ring body of the proximal end fixing ring.

[0036] In an embodiment of the present application, a distal fixing ring is further included, which is arranged at the distal end of the inner tube and used for fixing the distal end structure of the electrode assembly, and a plurality of distal end limiting portions corresponding to each electrode element are evenly arranged on the ring body of the distal fixing ring, and each distal end limiting portion has a distal end clamping groove used for clamping the distal end structure.

[0037] In an embodiment of the present application, the electrode assembly includes six electrode elements evenly arranged between the outer tube and the inner tube.

[0038] In summary, the pulse ablation device provided by the present application effectively solves the phenomenon that the electrode ball is easily damaged to the human body tissue when the operator pulls the inner tube with too large or too fast force, by arranging the buffer structure on the inner tube used for slowing down the expansion speed of the electrode assembly when the electrode assembly is converted from the contracted state to the expanded state, effectively buffering the speed of the diameter change of the electrode ball when the electrode ball is pulled, making the diameter change relatively gentle, and reducing the operation difficulty of the operator, which is beneficial to the operation. BRIEF DESCRIPTION OF DRAWINGS

[0039] The specific features of the application involved in the present application are shown in the appended claims. The features and advantages of the application involved in the present application can be better understood by referring to the exemplary embodiments and the accompanying drawings described in detail below. The drawings are briefly described as follows:

[0040] Figure 1 The schematic diagram of the pulse ablation system in an embodiment of the present application is shown.

[0041] Figure 2 The schematic diagram of the electrode assembly in an embodiment of the present application is shown. Figure 1 The enlarged schematic diagram of A in FIG. 4 is shown.

[0042] Figure 3 The schematic diagram of the electrode assembly in an embodiment of the present application is shown.

[0043] Figure 4 The schematic diagram of the electrode assembly in an embodiment of the present application is shown.

[0044] Figure 5 The schematic diagram of the structure of the fixing ring in an embodiment of the present application is shown.

[0045] Figure 6 The cross-sectional schematic diagram of the distal fixing ring arranged at the distal end of the inner tube in an embodiment of the present application is shown.

[0046] Figure 7 The schematic diagram of the inner tube with the buffer structure in an embodiment of the present application is shown.

[0047] Figure 8Figure 1 shows a schematic view of an inner tube and electrode assembly having a buffer structure in an embodiment of the present application in a collapsed state.

[0048] Figure 9 Figure 2 shows a schematic view of an inner tube and electrode assembly having a buffer structure in an embodiment of the present application in an expanded state.

[0049] Figure 10 Figure 3 shows a schematic view of an inner tube having a buffer structure in another embodiment of the present application.

[0050] Figure 11 Figure 4 shows a schematic view of an inner tube having a buffer structure in yet another embodiment of the present application.

[0051] Figure 12 Figure 5 shows a schematic view of an inner tube and electrode assembly having a buffer structure in another embodiment of the present application in an expanded state.

[0052] Figure 13 Figure 6 shows a schematic view of an inner tube and electrode assembly having a buffer structure in yet another embodiment of the present application in an expanded state.

[0053] Figure 14 Figure 7 shows a schematic view of an electrode assembly in an embodiment of the present application in a collapsed state.

[0054] Figure 15 Figure 8 shows a schematic view of an electrode assembly in an embodiment of the present application in an expanded state.

[0055] Figure 16 Figure 9 shows a schematic view of an ablation electrode element structure of an electrode assembly in an embodiment of the present application in a first perspective view.

[0056] Figure 17 Figure 10 shows a schematic view of an ablation electrode element structure of an electrode assembly in an embodiment of the present application in a second perspective view.

[0057] Figure 18 Figure 11 shows a schematic view of the coupling between electrode elements of an electrode assembly in an embodiment of the present application.

[0058] Figure 19 Figure 12 shows a schematic view of the coupling between electrode elements of an electrode assembly in another embodiment of the present application.

[0059] Figure 20 Figure 13 shows a schematic view of an electrode assembly in another embodiment of the present application in a collapsed state.

[0060] Figure 21 Figure 14 shows a schematic view of an electrode assembly in another embodiment of the present application in an expanded state.

[0061] Figure 22Figure 1 shows a first perspective view of an ablation electrode assembly according to an embodiment of the application.

[0062] Figure 23 Figure 2 shows a second perspective view of an ablation electrode assembly according to an embodiment of the application.

[0063] Figure 24 Figure 3 shows a second perspective view of an ablation electrode assembly according to another embodiment of the application.

[0064] Figure 25 Figure 4 shows a schematic view of an ablation electrode assembly according to an embodiment of the application having a single central link.

[0065] Figure 26 Figure 5 shows a schematic view of an ablation electrode assembly according to an embodiment of the application having a single central link.

[0066] Figure 27 Figure 6 shows a schematic view of an ablation electrode assembly according to an embodiment of the application having a double link.

[0067] Figure 28 Figure 7 shows a schematic view of an ablation electrode assembly according to another embodiment of the application having a double link.

[0068] Figure 29 Figure 8 shows a schematic view of an ablation electrode assembly according to an embodiment of the application having a triple link.

[0069] Figure 30 Figure 9 shows a schematic view of an ablation electrode assembly according to an embodiment of the application showing the coupling between the electrode elements.

[0070] Figure 31 Figure 10 shows a schematic view of an ablation electrode assembly according to another embodiment of the application showing the coupling between the electrode elements.

[0071] Figure 32 Figure 11 shows a schematic view of an ablation electrode assembly according to another embodiment of the application showing the coupling between the electrode elements.

[0072] Figure 33 Figure 12 shows a schematic view of an ablation electrode assembly according to another embodiment of the application showing the coupling between the electrode elements.

[0073] Figure 34 Figure 13 shows a schematic view of an ablation electrode assembly according to another embodiment of the application showing the coupling between the electrode elements.

[0074] Figure 35 Figure 14 shows a schematic view of an ablation electrode assembly according to an embodiment of the application showing the coupling between the electrode elements. DETAILED DESCRIPTION

[0075] The following detailed description is presented in order to describe the embodiments of the application and it is not intended that the application be limited thereto. Persons skilled in the art can be able to use the disclosure in other embodiments and with modification applicable to the

[0076] In the following description, reference is made to the accompanying drawings which form a part hereof, and in which several embodiments of the present application are shown by way of illustration. It is understood that other embodiments can be utilized and mechanical, structural, electrical, and operational changes can be made without departing from the spirit and scope of the present disclosure. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of the embodiments of the present application are defined only by the claims. The summary of the application does not purposely limit the application's scope. Spatially relative terms, such as "upper", "lower", "left", "right", "beneath", "below", "bottom", "above", "top", and the like, can be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientations depicted in the figures. For example, if the device described is turned over in use, a relative prefiix term such as "lower", can be used to describe a

[0077] While in some examples the terms first, second, etc. are used herein to describe various elements or parameters, these elements or parameters should not be limited by these terms. These terms are only used to distinguish one element or parameter from another. For example, a first proximal end rod can be termed a second proximal end rod, and similarly, a second proximal end rod can be termed a first proximal end rod, without departing from the scope of the various described embodiments. Both the first proximal end rod and the second proximal end rod are a proximal end rod that is located proximally, but they are not the same proximal end rod unless the context clearly indicates otherwise. Similar cases include a first distal end rod and a second distal end rod, etc.

[0078] Also, as used in the description herein and throughout this application, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises", "comprising", "includes" and / or "including", when used herein, specify the presence of stated features, steps, operations, elements, components, items, and / or groups thereof, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, items, and / or groups thereof. As used herein, the terms "or" and "and / or" are to be interpreted as inclusive, i.e., as meaning one or any combination of the items. Thus, "A, B or C" or "A, B and / or C" means any of the following: A; B; C; A and B; A and C; B and C; A, B and C. This definition also applies to other common terms such as in combination with "comprising", "including", "containing", "involving", "having", "featuring", "characterized by", "including", "comprising", "having" and the like.

[0079] Cardiac impulse electric field ablation is a new type of ablation method using impulse electric field as energy. Impulse electric field ablation is to release ablation energy by designing appropriate impulse electric field, using multiple electric impulses of short time and high voltage, so that the ablation process is non-thermal energy ablation (no Joule heat), effectively inducing cardiac muscle cells to undergo electroporation, making extracellular ions enter the cells, leading to the death of cardiac muscle cells. The damage to the tissues with high threshold value of impulse electric field is also reversible, so as to selectively damage the myocardial conduction system and avoid complications caused by damage to other surrounding tissues; compared with traditional radiofrequency and cryogenic energy, impulse electric field ablation is non-thermal energy ablation, so impulse electric field can selectively damage myocardium while preserving blood vessels, nerves and surrounding tissues of the heart, such as lung, esophagus, phrenic nerve, etc.

[0080] In the present application, when describing any one component or part of the handle, ablation catheter or electrode assembly in the pulse ablation device or ablation device, the terms "proximal end" and "distal end" are the relative orientation, relative position and direction of elements or actions relative to each other from the perspective of the doctor using the product, although "proximal end" and "distal end" are not restrictive, but "proximal end" generally refers to the end of the product close to the doctor during normal operation, and "distal end" generally refers to the end first entering the patient's body. It can also be said that "proximal end" refers to the side close to the user / operator direction, and correspondingly, "distal end" refers to the side away from the user / operator direction; for example, when the ablation catheter delivers the electrode assembly to the target tissue site in the human body, the "distal end" is the side close to the target tissue; in the present application, "proximal end" and "distal end" are used to indicate a direction, and do not refer to a specific component or part in a device / element. For example, the "proximal end" of the ablation catheter refers to the end of the ablation catheter in the user / operator direction in the use state, and the "distal end" of the ablation catheter refers to the end of the ablation catheter away from the user / operator direction in the use state, and it should be understood that in the description of the present application, "proximal side" or "distal side" and the like can also be used to indicate a relative orientation, relative position or direction.

[0081] In the present application, the term "coupling" or "connection" refers to the mechanical combination between two components or parts, which can be a combination that can be disassembled or assembled, or a combination that cannot be separated and is integrally formed; in the present application, the term "integrally formed" refers to a structure formed by a machining process such as stamping, cutting, pouring, casting, injection molding, etc. The structure is an element as a whole and cannot be separated.

[0082] In the present application, the term "electrically connected" refers to an electrical connection for the transmission of electrical signals between two parts. For example, in some embodiments of the present application, the electrode element and the electrode connector in the electrode assembly are electrically connected by the electrode lead wire.

[0083] In the present application, the term "axial movement" refers to movement in the direction of the axial centerline, such as the axial movement of the inner tube, which means that the inner tube as a whole can move in the direction of its axial centerline, which can be from the distal end to the proximal end or from the proximal end to the distal end.

[0084] In the present application, the term "electroporation" is a phenomenon that causes the cell membrane to become "leaky" (i.e., permeable to molecules that the cell membrane would otherwise be impermeable or semi-permeable to); can also be referred to as electroporation of electropermeabilization, pulsed electric field treatment, non-thermal irreversible electroporation, irreversible electroporation, high-frequency irreversible electroporation, nanosecond electroporation, or nanoelectroporation involves the application of high-amplitude pulses to cause physiological modification of the cells of the tissue to which the energy is applied. These pulses can preferably be short, e.g., nanosecond, microsecond, or millisecond pulse width pulses, in order to allow the application of high voltages, high currents (e.g., 20 amperes or greater), without the long duration of flow that can cause significant tissue heating and muscle stimulation. The pulsed electric energy can induce the formation of microscopic defects that cause the over-permeabilization of the cell membrane. Depending on the characteristics of the electric pulses, electroporated cells can survive after electroporation, referred to as "reversible electroporation" or die after electroporation, referred to as "irreversible electroporation". Reversible electroporation can be used to deliver agents including genetic material and other macromolecules or small molecules into target cells for various purposes, including altering the action potential of cardiomyocytes.

[0085] In the present application, the term "electroporation" as used refers to the application of an electric field to a cell membrane to change the permeability of the cell membrane to the extracellular environment. The term "reversible electroporation" as used herein refers to the application of an electric field to a cell membrane to temporarily change the permeability of the cell membrane to the extracellular environment. For example, a cell that undergoes reversible electroporation can be observed to have temporary and / or intermittent formation of one or more pores in its cell membrane that close upon removal of the electric field. The term "irreversible electroporation" as used herein refers to the application of an electric field to a cell membrane to permanently change the permeability of the cell membrane to the extracellular environment. For example, a cell that undergoes irreversible electroporation can be observed to have formation of one or more pores in its cell membrane that remain present upon removal of the electric field.

[0086] The disclosed pulsed ablation system includes a control device or delivery console and a pulsed ablation device, wherein the control device or delivery console provides pulsed ablation energy output and control, measurement and / or monitoring of a patient's physiological condition, and in response to the monitored / measured condition, provides one or more predetermined or automatic programs to deliver ablation or treatment energy. For example, processing circuitry can be configured to execute a treatment program prior to or concurrent with delivery of ablation or treatment energy. The control unit can include dedicated user input devices (e.g., buttons, switches, GUI interfaces provided by a touchscreen, etc.) that allow an operator to quickly and easily execute relevant programs prior to initiating delivery of treatment or ablation energy, such as system parameters, medical devices used, target tissue types, non-target tissue types, energy modalities intended for treatment, user's assessment / judgment, etc.

[0087] The pulsed ablation device can be directly coupled to a control device or delivery console, such as a pulsed electric field generator that includes an energy control, delivery, and monitoring system. The control device or delivery console can also include a controller in communication with the generator for operating and controlling various functions of the generator. Further, the pulsed ablation device can include one or more diagnostic or treatment zones for energy, treatment, and / or detection or diagnostic interaction between the pulsed ablation device and a treatment site. The pulsed ablation device can deliver pulsed electric field electroporation energy to a target tissue region proximate to one or more treatment zones.

[0088] Referring to Figure 1 , a schematic diagram of a pulsed ablation system in an embodiment of the present application is shown, as illustrated, the pulsed ablation system includes a delivery console 1 and a pulsed ablation device 2; wherein the pulsed ablation device 2 includes an operating handle 20, an ablation catheter 30, and electrode assemblies 40, 50.

[0089] In the present application, the ablation catheter 30 can be a catheter that can be delivered to a target tissue region via a sheath or intravascular introducer, such as the use state of the ablation catheter 30, the guide sheath is pre-inserted into the right ventricle via the superior vena cava, the right atrium, the distal end of the ablation catheter 30 is extended from the distal end of the guide sheath, and inserted into the predetermined position of the ventricular wall, the electrode assemblies 40, 50 are extended out, then the electrode assemblies 40, 50 are inflated by operation, and the pulsed energy is released under the control of the control device to perform ablation. The elongated body of the ablation catheter 30 can define a proximal end portion, a distal end portion, and a longitudinal axis, and can further include one or more lumens arranged within its elongated body to provide mechanical communication, electrical communication, and / or fluid communication between the proximal end portion and the distal end portion of the elongated body.

[0090] Referring toFigure 2 shown as Figure 1 As shown in the enlarged view of A in FIG. 1, the ablation catheter 30 comprises an outer tube 31 and an inner tube 32 extending from a proximal end to a distal end, wherein the proximal end of the outer tube 31 is fixed on an operating handle, and the distal ends of the outer tube 31 and the inner tube 32 are fixed with an electrode assembly 40, 50. Specifically, the distal end of the outer tube 31 is provided with a plurality of electrode elements, and the proximal end structure of each electrode element is fixed on the distal end portion of the outer tube 31. The inner tube 32 is arranged in the outer tube 31 and can move axially relative to the outer tube 31 (as shown by the arrow in FIG. 1), that is, the inner tube 32 can be operated to make a telescopic movement in the outer tube 31. Figure 2

[0091] The distal end of the inner tube 32 is fixed with the electrode assembly 40, 50. Specifically, the distal end of the inner tube 32 is provided with a plurality of electrode elements together with the distal end of the outer tube 31, and the proximal end structure of each electrode element is fixed on the distal end portion of the outer tube 31, and the distal end structure of each electrode element is fixed on the distal end portion of the inner tube 32, so that the plurality of electrode elements in the electrode assembly 40, 50 are fixed between the distal end of the outer tube 31 and the distal end of the inner tube 32. Thus, when the inner tube 32 and the outer tube 31 move relative to each other, the plurality of electrode elements in the electrode assembly 40, 50 are converted between the contracted state and the expanded state.

[0092] Please refer to Figure 3 , shown as the electrode assembly contracted state schematic diagram in an embodiment of the present application, as shown in the figure, in the present application, the contracted state of the electrode assembly 40, 50 refers to the state that the proximal end portion / proximal end structure of each electrode element in the plurality of electrode elements in the electrode assembly 40, 50 gradually moves away from the distal end portion / distal end structure thereof, until the proximal end portion / proximal end structure and the distal end portion / distal end structure of each electrode element reach the maximum distance, at this time, the electrode assembly 40, 50 as a whole presents a long strip shape, presents the state as shown in Figure 3 .

[0093] Please refer to Figure 4 , shown as the electrode assembly expanded state schematic diagram in an embodiment of the present application, as shown in the figure, in the present application, the expanded state of the electrode assembly 40, 50 refers to the state that the proximal end portion / proximal end structure of each electrode element in the plurality of electrode elements in the electrode assembly 40, 50 gradually approaches the distal end portion / distal end structure thereof, and the whole electrode assembly 40, 50 presents a spherical expansion, presents the state as shown in Figure 4 ​​The intermediate portion / connection structure between the proximal portion / proximal structure and the distal portion / distal structure of each of the plurality of electrode elements tends to move away from the axis of the electrode assembly 40, 50 until the proximal portion / proximal structure and the distal portion / distal structure of each of the plurality of electrode elements reach a preset minimum distance.

[0094] In some embodiments, the outer tube 31 or the inner tube 32 of the ablation catheter 30 is made of a material including polyether block amide, nylon, polyurethane, or silicone, etc. In some embodiments, the ablation catheter 30 is equipped with a steerable function, so that the ablation catheter 30 can reach any tissue site of the heart as needed to adapt to various lesion sites. The ablation catheter 30 is a braided tube made of polyurethane and PEBAX material and stainless steel wire, which has good torque response and support. Alternatively, in some other embodiments, the material of the ablation catheter 30 is a high polymer material, and more preferably a thermoplastic material, which includes one or more combinations of PET (polyethylene terephthalate), PEBAX (polyether amide), PTFE (polytetrafluoroethylene), PI (polyimide), and PA (nylon) high polymer materials, so as to obtain the ablation catheter 30 with certain hardness and softness, which not only avoids damage to the electrode lead or the pull wire arranged inside the ablation catheter 30, but also better isolates the electrode lead or the pull wire. More preferably, the material of the ablation catheter 30 is PET material, so as to obtain a sleeve with certain hardness, which avoids deformation of the ablation catheter 30 during the movement of the pull wire, so that the ablation catheter 30 has better use effect.

[0095] In the present application, the plurality of electrode elements in the electrode assembly 40, 50 are fixed on the outer tube 31 or the inner tube 32 by the fixing ring.

[0096] Please refer to Figure 5 , which shows a structural schematic diagram of the fixing ring in an embodiment of the present application. It should be noted that the fixing ring fixed on the outer tube 31 or the inner tube 32 is a similar structure, and the fixing ring fixed on the outer tube 31 is a proximal fixing ring 33 in the following embodiments, and the fixing ring fixed on the distal end of the inner tube is a distal fixing ring 34 in the following embodiments.

[0097] In an embodiment, the distal end of the outer tube 31 (such as Figure 4A proximal fixing ring 33 is disposed within the lumen (shown at point D1). The proximal fixing ring 33 is used to fix the proximal structure of the electrode assembly. Multiple proximal limiting portions are evenly distributed on the ring body of the proximal fixing ring 33. Each of the multiple proximal limiting portions corresponds to fixing one electrode element. In this embodiment, each proximal limiting portion has a proximal locking groove 331 for engaging the proximal structure. A covering layer (not shown) for fixing the electrode assembly is wrapped around the ring body of the proximal fixing ring 33. The covering layer encloses the proximal portion / proximal structure of each of the multiple electrode elements in the electrode assembly within the proximal locking groove 331 of the proximal fixing ring 33 to reinforce the fixation of the electrode assembly on the proximal fixing ring 33. The covering layer is an insulating material, such as insulating tape.

[0098] Please see again Figure 6 The figure shows a cross-sectional view of a distal fixing ring disposed at the distal end of the inner tube in one embodiment of this application. As shown in the figure, in this embodiment, the distal end of the inner tube 32 (e.g., Figure 4 A distal fixing ring 34 is disposed within the lumen (as shown at point D2). The distal fixing ring 34 is used to fix the distal structure of the electrode assembly. Multiple distal limiting portions are evenly distributed on the ring body of the distal fixing ring 34. Each of the multiple distal limiting portions corresponds to fixing one electrode element. In this embodiment, each distal limiting portion has a distal locking groove 341 for engaging the proximal structure. Multiple distal locking grooves 341 are formed on the surrounding sidewalls of the distal fixing ring 34 for engaging the distal structure of the electrode assembly. The distal portion / distal structure of each of the multiple electrode elements in the electrode assembly is secured in the corresponding distal locking groove 341.

[0099] In this application, a buffer structure is provided on the inner tube. This buffer structure slows down the expansion rate of the electrode assembly when it transitions from a contracted state to an expanded state. In this embodiment, the buffer structure ensures that when the inner tube moves towards the proximal end relative to the outer tube (i.e., the outer tube is stationary while the inner tube moves towards the proximal end), the initial velocity of the proximal portion of the inner tube is greater than the initial velocity of the distal portion due to the buffer structure. This effectively slows down the expansion rate of the electrode assembly when it transitions from a contracted state to an expanded state.

[0100] In the present application, by setting a buffer structure on the inner tube, the phenomenon that the electrode ball expands too fast or too large to easily hurt the human body tissue when the operator pulls the inner tube with too large or too fast force is effectively solved. In one embodiment of the present application, for example, by utilizing the elastic axis of the screw rod, the speed of the diameter change of the electrode ball when pulling the electrode ball is effectively buffered, so that the diameter change is relatively gentle, and the operation difficulty of the operator is also reduced, which is beneficial to the operation.

[0101] In some embodiments, the buffer structure is an axial elastic structure or an axial elastic material integrally formed on the inner tube. The axial elastic material is, for example, a material with a certain elastic modulus or elastic deformation amount, such as plastic or rubber.

[0102] Please refer to Figure 7 , which shows the inner tube with a buffer structure in an embodiment of the present application. As shown in the figure, in this embodiment, the buffer structure 321 is a compression spring sleeved on the section of the inner tube 32 corresponding to the proximal end D1 to the distal end D2 of the electrode assembly.

[0103] Please refer to Figure 8 and Figure 9 , wherein, Figure 8 shows the inner tube and the electrode assembly with a buffer structure in a contracted state in an embodiment of the present application, Figure 9 shows the inner tube and the electrode assembly with a buffer structure in an expanded state in an embodiment of the present application. As shown in the figure, in this embodiment, when the inner tube 32 moves axially towards the proximal end (i.e. in the direction of the arrow shown in FIG. 9), Figure 8 or 9), the part located at the distal end of the inner tube 32 abuts against and compresses the buffer structure 321 which is a compression spring. Due to the elastic ability of the compression spring itself, when compressed, it generates a reverse elastic force (as shown in the direction of the arrow marked on the compression spring in Figure 7 ), which acts on the distal end of the inner tube 32, thereby reducing the movement speed of the distal end of the inner tube 32. The initial speed v1 of the proximal end D1 part of the inner tube 32 is greater than the initial speed v2 of the distal end part D2 of the inner tube 32, thereby playing a role in slowing down the expansion speed of the electrode assembly when the electrode assembly 40, 50 is converted from the contracted state to the expanded state. In the embodiment in which the distal end of the inner tube 32 is provided with a distal end fixing ring, Figure 7The buffer structure 321 abuts and compresses the compression spring. In this embodiment, the axial elasticity of the spring structure 321' formed on the inner tube 32 can slow down the speed of the electrode ball diameter change when the electrode ball is pulled in the proximal direction, making the diameter change relatively gentle, and also reducing the difficulty of the operator's operation.

[0104] Referring to Figure 10 , which shows a schematic diagram of the inner tube with a buffer structure in another embodiment of the present application. As shown in the figure, in this embodiment, the buffer structure is an axial elastic structure, such as a spring structure 321', which is integrally formed on the inner tube 32. In one example, the inner tube 32 is made of medical plastic material, and the spring structure 321' formed on the inner tube 32 is also made of medical plastic material, which has a certain modulus of elasticity or elastic deformation when stretched. Figure 10 In this embodiment, when the inner tube 32 moves axially towards the proximal end, the part at the distal end of the inner tube 32 abuts and compresses the spring structure 321'. Due to the elastic ability of the spring structure 321' itself, when it is compressed, it generates a reverse elastic force (as shown by the arrow on the spring structure 321' in the figure) acting on the distal end of the inner tube 32, thereby reducing the movement speed of the distal end of the inner tube 32. The initial speed v1 of the proximal end D1 of the inner tube 32 is greater than the initial speed v2 of the distal end D2 of the inner tube 32, thereby playing a role in slowing down the expansion speed of the electrode assembly when the electrode assembly is converted from the collapsed state to the expanded state. Figure 7 In this embodiment, the axial elasticity of the spring structure 321' formed on the inner tube 32 can slow down the speed of the electrode ball diameter change when the electrode ball is pulled in the proximal direction, making the diameter change relatively gentle.

[0105] In one embodiment, the section of the inner tube 32 corresponding to the proximal end to the distal end of the electrode assembly is a flexible section that can bend when subjected to a non-axial force (for example Figure 10The spring structure 321' shown can better or more effectively bring a portion of the electrode assembly into contact with or close to the target tissue to achieve the desired therapeutic effect. In this embodiment, the flexible sections at both ends of the inner tube 32 corresponding to the electrode assembly can be achieved by changing the material or structure. In one example, when manufacturing the inner tube 32, the material of the flexible section is differentiated from other parts to give the flexible section a lower elastic modulus or rigidity. In another example, the flexible section can be achieved by changing the structural design of the portion at both ends of the inner tube 32 corresponding to the electrode assembly, such as the spring structure described above.

[0106] Please see Figure 11 The figure shows a schematic diagram of an inner tube with a buffer structure in another embodiment of this application. As shown, in this embodiment, the buffer structure is a spring structure 321” whose diameter decreases from the proximal end to the distal end. In this embodiment, the two ends of the buffer structure 321” have different diameters, that is, the diameter of the proximal end of the spring structure 321” is larger than the diameter of the distal end (as shown in the figure), to accommodate the phenomenon that the diameter of veins in human tissue decreases. In one example, for example, the inner tube 32 is made of medical plastic, and the spring structure 321” formed on the inner tube 32 as a buffer structure is also made of medical plastic, which has a certain elastic modulus or elastic deformation when stretched. Furthermore, the section of the inner tube 32 corresponding to the proximal to distal end of the electrode assembly is a flexible section that can be bent when subjected to non-axial force (e.g. Figure 11 The spring structure 321” shown is a flexible section with a decreasing diameter from the proximal end to the distal end, which can better or more conveniently allow a portion of the electrode assembly to contact or approach the target tissue to achieve the desired therapeutic effect.

[0107] Please see Figure 12 The figure shows a schematic diagram of the expansion state of the inner tube and electrode assembly with a buffer structure in another embodiment of this application. As shown in the figure, in this embodiment, when the inner tube 32 moves axially toward the proximal end, the portion D2 located at the distal end of the inner tube 32 abuts against and compresses the spring structure 321". Due to the elasticity of the spring structure 321", it generates a reverse elastic force when compressed (e.g., ...). Figure 11The spring structure 321" is shown in the direction of the arrow marked on the spring structure 321" acts on the distal end of the inner tube 32, thereby reducing the movement speed of the distal end of the inner tube 32, the initial speed v1 of the proximal end D1 part of the inner tube 32 is greater than the initial speed v2 of the distal end part D2 of the inner tube 32, thereby slowing down the expansion speed of the electrode assembly when the electrode assembly is converted from the collapsed state to the expanded state. In the embodiment in which the distal end of the inner tube 32 is provided with a distal end fixing ring, when the inner tube 32 moves axially towards the proximal end, the distal end fixing ring at the distal end of the inner tube 32 (not shown in the figure) abuts and compresses the spring structure 321". Figure 9 In this embodiment, for example, by using the elastic of the axis of the helical rod structure formed on the inner tube 32, the speed of the change in the diameter of the electrode ball can be slowed down when the electrode ball is axially moved in the proximal direction to buffer the traction of the electrode ball, so that the change in the diameter of the electrode ball is relatively gentle. Figure 10 Or Figure 11 In the embodiment shown, the inner tube 32 is a tube body with a decreasing diameter from the proximal end to the distal end, so as to adapt to the phenomenon that the diameter of the vein in the human body tissue decreases.

[0108] As shown in Figure 10 Or Figure 11 The buffer structure is integrally formed in the section of the inner tube 32 corresponding to the proximal end to the distal end of the electrode assembly 40, 50, that is, the inner tube 32 is arranged in the outer tube 31, and the distal end part of the inner tube 32 continues to extend a certain length from the distal end outlet of the outer tube 31 to the end part at the distal end thereof, in this embodiment, the inner tube 32 includes a smooth section 322 for being arranged in the outer tube 31 and extending from the proximal end to the distal end of the outer tube 31 to the distal end part of the outer tube 31, a fixing section 323 protruding from the distal end of the outer tube 31 for fixing the distal end of the electrode assembly 40, 50, and a buffer structure 321" formed between the smooth section 322 and the fixing section 323.

[0109] In the embodiment shown in Figure 11 And Figure 12 The two ends of the electrode assembly 40, 50 are fixed in the smooth section 322 and the fixing section 323 respectively, specifically, the proximal end structure of the electrode assembly 40, 50 is fixed in the smooth section 322, the distal end structure of the electrode assembly 40, 50 is fixed in the fixing section 323, and the buffer structure 321" is integrally formed between the smooth section 322 and the fixing section 323, when the inner tube 32 is operated to move axially towards the proximal end, due to the buffer structure 321" between the smooth section 322 and the fixing section 323 of the inner tube 32, the initial speed v1 of the smooth section 322 part of the inner tube 32 (i.e. the part of D1 shown in Figure 11 The figure) is greater than the initial speed v2 of the fixing section 323 part of the distal end of the inner tube 32 (i.e. the part of D2 shown in Figure 11The initial velocity v2 of the portion D2 shown in the figure serves to slow down the expansion rate of the electrode assemblies 40, 50 as they transition from a contracted state to an expanded state.

[0110] exist Figure 11 and Figure 12 In the illustrated embodiment, the fixed section 323 of the inner tube 32 is provided with a limiting structure 3231 for restricting the displacement of the distal ends of the electrode assemblies 40, 50 relative to the inner tube 32. In this embodiment, the limiting mechanism is a protruding structure formed on the side wall of the outer tube 31, such as a rib structure, continuous or discontinuous protrusions, or a flange formed at the port of the distal end of the inner tube 32. In this embodiment, a distal fixing ring 34 is provided in the lumen of the distal end of the inner tube 32. The distal fixing ring 34 is used to fix the distal structure of the electrode assemblies 40, 50. The limiting structure is used to restrict the axial movement of the inner tube 32 towards the proximal end. The limiting structure can drive the distal fixing ring 34 to move axially towards the proximal end as well, thereby avoiding the risk of the distal fixing ring 34 detaching from the inner tube 32 due to poor fixation at the distal end of the inner tube 32.

[0111] In other embodiments, the buffer structure is integrally formed in the middle section of the inner tube (not shown), please refer to [reference needed]. Figure 13 The figure shows a schematic diagram of the expansion state of the inner tube and electrode assembly with a buffer structure in another embodiment of this application. As shown, the buffer structure 321”’ is integrally formed in the middle section of the inner tube, that is, the buffer structure 321”’ is not integrally formed in the section of the inner tube corresponding to the proximal to distal end of the electrode assembly 40, 50, but is integrally formed in the middle section of the inner tube, for example. Figure 13 The intermediate section is shown in the figure. In another possible embodiment, the buffer structure is integrally formed in the section adjacent to the proximal end of the inner tube (not shown). In the above embodiments, when the inner tube 32 is operated to move axially proximally, the initial velocities of the two ends of the buffer structure 321”' are different; that is, the initial velocity of the proximal portion of the buffer structure 321”' is greater than the initial velocity of the distal portion of the buffer structure, thereby slowing down the expansion rate of the electrode assembly 40, 50 when the electrode assembly transitions from a contracted state to an expanded state.

[0112] Presented as above Figure 5 and Figure 6In the shown embodiment, the ring body of the distal fixing ring 34 is uniformly provided with a plurality of distal limiting portions, each of the plurality of distal limiting portions corresponds to fixing one electrode element. In the present embodiment, a plurality of distal clamping grooves 341 for clamping the distal structure of the electrode assembly 40, 50 are provided on the peripheral sidewall of the distal fixing ring 34. The distal portion / distal structure of each of the plurality of electrode elements in the electrode assembly 40, 50 is clamped in the corresponding distal clamping groove 341.

[0113] In the pulse ablation catheter 30 or the pulse ablation device with the pulse ablation catheter 30 provided in the present application, the phenomenon that the electrode ball is easily to hurt the human body tissue due to the electrode ball expanding too fast or too large when the operator pulls the inner tube 32 with too large or too fast force is effectively solved by providing the buffer structure 321, 321', 321", or 321'" on the inner tube 32. In one embodiment provided in the present application, for example, the axis elasticity of the screw rod effectively buffers the speed of the diameter change of the electrode ball when the electrode ball is pulled, so that the diameter change of the electrode ball is relatively gentle, and the operation difficulty of the operator is also reduced, which is beneficial to the operation.

[0114] In some embodiments, the inner tube 32 of the ablation catheter 30 can have a lumen that can receive a guide wire 28, so that the distal end portion of the catheter can be delivered to the treatment site online. The lumen of the inner tube 32 can be configured to receive guide wires 28 of various sizes. In some embodiments, the guide wire 28 can be introduced into the inner tube 32 through the guide wire inlet of the handle.

[0115] In some embodiments, the ablation catheter 30 is provided with a passage (not shown) for the traction line and the electrode lead wire to pass through. In one embodiment, for example, one or more sleeves or sleeves (not shown) are provided between the outer tube 31 and the inner tube 32, and the sleeves or sleeves are provided with passages for the traction line and the electrode lead wire to pass through. In another embodiment, the passage for the traction line and the electrode lead wire to pass through can also be provided on the tube body of the outer tube 31, such as the lead or guide wire passage provided in the tube wall of the outer tube 31, so that the traction line extends from the distal end of the ablation catheter 30 to the traction mechanism of the handle; and the electrode lead wire extends from the electrode assembly 40, 50 fixed at the distal end of the ablation catheter 30 to the electrode connector on the handle and is electrically connected to the electrode connector.

[0116] In the present application, the pulsed ablation device further includes an electrode assembly comprised of one or more electrode elements (which in some examples can also be referred to as treatment elements) at, coupled to, or on a distal end portion of the elongated body of the ablation catheter for energy, treatment, and / or research or testing interaction between the ablation device and a treatment site or region. As a non-limiting example, the electrode assembly can be transitionable between a collapsed state and an expanded state in which each electrode element has an arcuate or substantially circular configuration. For example, the electrode elements can form a sphere or other expanded body structure such as a spherical, conical, football, hourglass, pear, onion, etc. in the expanded state, which can have a cross-section in a plane substantially normal to the longitudinal axis of the elongated body.

[0117] In one embodiment, the degree of expansion of the electrode assembly in the expanded state determines the degree of contact of each of the electrode elements with tissue. The spherical surface orientation of the expanded sphere can facilitate the application of energy from the plurality of electrode elements to target tissue at the treatment site in close proximity or contact. In one example, the target tissue is, for example, target tissue in a human heart, such as a pulmonary vein ostium.

[0118] In the present application, the plurality of electrode elements in the electrode assembly can also perform diagnostic functions such as collecting intracardiac electrocardiogram / electrogram (EGM or EKG) / or monophasic action potential (MAP) and performing selective pacing of intracardiac sites for diagnostic purposes. The measured signals can be fed back to a control device, and the plurality of electrode elements in the electrode assembly can also monitor proximity to target tissue and quality of contact with such tissue using impedance-based measurements. The energy generator of the control device can include high speed relays to disconnect / reconnect specific electrodes from the generator during energy delivery procedures. The relays can reconnect one or more electrode elements for diagnostic purposes following pulsed energy delivery.

[0119] In the present application, as Figure 1As shown, the electrode assembly 40, 50 includes a plurality of electrode elements disposed between the outer tube 31 and the inner tube 32 of the ablation catheter 30, each electrode element including a proximal structure fixed to the distal end of the outer tube 31 and a distal structure fixed to the distal end of the inner tube 32; that is, the distal ends of the inner tube 32 and the outer tube 31 are collectively provided with a plurality of electrode elements, the proximal structure of each electrode element is fixed to the distal end portion of the outer tube 31, and the distal structure of each electrode element is fixed to the distal end portion of the inner tube 32, so that the plurality of electrode elements in the electrode assembly 40, 50 are fixed between the distal end of the outer tube 31 and the distal end of the inner tube 32, and thus, the inner tube 32 and the outer tube 31 are relatively moved to convert the plurality of electrode elements in the electrode assembly between the contracted state and the expanded state.

[0120] In embodiments, the electrode assembly 40, 50 includes a plurality of electrode elements, and in some embodiments, the control device or delivery console can be configured to electrically connect a set of electrode elements of an ablation device to a set of electrode channels. The control device or delivery console can be configured to selectively deliver energy to the set of electrodes using the set of electrode channels. One or more ablation devices each having a set of electrodes can be connected to the delivery console. The set of electrodes can include any number of electrodes, such as 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20, or more electrodes. In one embodiment, the number of electrode elements of the electrode assembly, for example, is 6.

[0121] In some embodiments, the electrode elements of the electrode assembly 40, 50 are of a material such as Nitinol, and the electrode elements can also be coated with one or more of gold, tantalum, iridium oxide, or other materials.

[0122] In the following embodiments herein, a single electrode element of the electrode assembly is referred to as an ablation electrode element, please refer to Figure 14 and Figure 15 , Figure 14 a contracted state schematic diagram of the electrode assembly in an embodiment of the present application is shown, Figure 15 an expanded state schematic diagram of the electrode assembly in an embodiment of the present application is shown, as shown, the ablation electrode element 41 includes a proximal double-bar structure 411, a distal double-bar structure 413, and a single-bar structure 412.

[0123] The proximal double-bar structure 411 is located at the proximal end D1, specifically, the proximal double-bar structure 411 is fixed at the distal end of the outer tube 31 of the ablation catheter 30, correspondingly, the distal double-bar structure 413 is located at the distal end D2, specifically, the distal double-bar structure 413 is fixed at the distal end of the inner tube 32 of the ablation catheter 30, the single-bar structure 412 is connected between the proximal double-bar structure 411 and the distal double-bar structure 413, the proximal double-bar structure 411 and the distal double-bar structure 413 move relatively to make the ablation electrode element 41 transform between the contracted state and the expanded state, the single-bar structure 412 provides the contraction traction force to the proximal double-bar structure 411 and the distal double-bar structure 413 in the contracted state or provides the expansion biasing force to the proximal double-bar structure 411 and the distal double-bar structure 413 in the expanded state.

[0124] For example, when the inner tube 32 of the ablation catheter 30 moves axially towards the proximal direction, the distal double-bar structure 413 of the ablation electrode element 41 fixed at the distal end of the inner tube 32 also moves towards the proximal direction, while the position of the proximal double-bar structure 411 fixed at the distal end of the outer tube 31 does not change, at this time, the ablation electrode element 41 gradually changes from the contracted state to the expanded state, in this process, the single-bar structure 412 provides the expansion biasing force to the proximal double-bar structure 411 and the distal double-bar structure 413 in the expanded state, until the ablation electrode element 41 reaches the expected expansion degree; in this application, the expansion biasing force is a support force providing a certain biasing direction, that is, the support forces at both ends of the single-bar structure 412 are not parallel to the axial direction of the inner tube 32 or the electrode assembly, in the two-dimensional projection relationship, the biasing direction intersects with the circumferential direction at a certain angle, so that the single-bar structure 412 can support the ablation electrode element 41 to be raised in the middle and have a certain curvature when the ablation electrode element 41 gradually changes from the contracted state to the expanded state. Correspondingly, when the inner tube 32 of the ablation catheter 30 moves axially towards the distal direction, the distal double-bar structure 413 of the ablation electrode element 41 fixed at the distal end of the inner tube 32 also moves towards the distal direction, while the position of the proximal double-bar structure 411 fixed at the distal end of the outer tube 31 does not change, at this time, the ablation electrode element 41 gradually changes from the expanded state to the contracted state, the single-bar structure 412 provides the contraction traction force to the proximal double-bar structure 411 and the distal double-bar structure 413 in the contracted state, until the expected contraction degree is reached.

[0125] In an embodiment, in order to better achieve the purpose of the single-bar structure 412 providing the expansion biasing force to the proximal double-bar structure 411 and the distal double-bar structure 413 in the expanded state, the single-bar structure 412 is a link with curvature, that is, the single-bar structure 412 has a certain curvature in the natural state without force.

[0126] In an embodiment, the proximal double-bar structure 411, the distal double-bar structure 413, and the single-bar structure 412 are integrally formed structures. That is, the proximal double-bar structure 411, the distal double-bar structure 413, and the single-bar structure 412 are integrally formed structures prepared on a single material by laser cutting or other preparation processes. In a specific implementation, the material of the ablation electrode element 41 is, for example, nitinol material, and the electrode element can also be coated with one or more of gold, tantalum, iridium oxide, or other materials.

[0127] Please refer to Figure 16 and Figure 17 , Figure 16 shows a first view schematic diagram of the ablation electrode element structure of the electrode assembly in an embodiment of the present application, Figure 17 shows a second view schematic diagram of the ablation electrode element structure of the electrode assembly in an embodiment of the present application. As shown in the figure, in the present embodiment, the proximal double-bar structure 411 includes a proximal limiting rod 4110, and a first proximal rod 4111 and a second proximal rod 4112 which are formed from the proximal limiting rod 4110 and are symmetrical to each other; correspondingly, the distal double-bar structure 413 includes a distal limiting rod 4130, and a first distal rod 4131 and a second distal rod 4132 which are formed from the distal limiting rod 4130 and are symmetrical to each other. In the present embodiment, the proximal limiting rod 4110 of the proximal double-bar structure 411 and the distal limiting rod 4130 of the distal double-bar structure 413 are located on the same axial line, which should be understood as the axial line from the perspective of a single ablation electrode element 41, and it can also be understood that the proximal limiting rod 4110 of the proximal double-bar structure 411 and the distal limiting rod 4130 of the distal double-bar structure 413 are located on the same straight line.

[0128] In an embodiment, the first proximal rod 4111 and the second proximal rod 4112 in the proximal double-bar structure 411 have the same rod diameter or width, and in the present embodiment, the width or rod diameter of the proximal limiting rod 4110 is greater than that of the first proximal rod 4111 or the second proximal rod 4112; correspondingly, the first distal rod 4131 and the second distal rod 4132 in the distal double-bar structure 413 have the same rod diameter or width, and in the present embodiment, the width or rod diameter of the distal limiting rod 4130 is greater than that of the first distal rod 4131 or the second distal rod 4132.

[0129] In an embodiment, the diameter or width of the first proximal rod 4111 or the second proximal rod 4112 of the proximal double-rod structure 411 is equal to the diameter or width of the first distal rod 4131 and the second distal rod 4132 of the distal double-rod structure 413. In this embodiment, the diameter or width of the first proximal rod 4111 or the second proximal rod 4112 of the proximal double-rod structure 411, the diameter or width of the first distal rod 4131 and the second distal rod 4132 of the distal double-rod structure 413, and the diameter or width of the single rod structure 412 are the same.

[0130] In an embodiment, the proximal limiting rod 4110, the first proximal rod 4111, and the second proximal rod 4112 of the proximal double-rod structure 411 are integrally formed; correspondingly, the distal limiting rod 4130, the first distal rod 4131, and the second distal rod 4132 of the distal double-rod structure 413 are integrally formed. In this embodiment, as described above, the proximal double-rod structure 411, the distal double-rod structure 413, and the single rod structure 412 are integrally formed.

[0131] In this embodiment, the proximal limiting rod 4110 is used to fix the proximal end of the ablation electrode element 41 at the distal end of the outer tube 31, and the distal limiting rod 4130 is used to fix the distal end of the ablation electrode element 41 at the distal end of the inner tube 32. As described above, a proximal fixing ring 33 is arranged in the lumen of the distal end of the outer tube 31, and a plurality of proximal limiting portions are uniformly arranged on the ring body of the proximal fixing ring 33. Each proximal limiting portion has a proximal clamping groove 331 for clamping the proximal double-rod structure 411. Correspondingly, the proximal side of the proximal limiting rod 4110 of the proximal double-rod structure 411 has a proximal neck portion 41101 corresponding to the structure of the proximal clamping groove 331. The proximal neck portion 41101 can be clamped in the proximal clamping groove 331, thereby fixing the proximal end of the ablation electrode element 41 at the distal end of the outer tube 31. In this embodiment, the proximal clamping groove 331 includes two wider grooves and a narrower groove between the two wider grooves, and the proximal neck portion 41101 of the proximal limiting rod 4110 is clamped in the narrower groove. Preferably, the ring body of the proximal fixing ring 33 is wrapped with a coating layer for fixing the electrode assembly. The coating layer wraps the proximal limiting rod 4110 of the proximal double-rod structure 411 of each of the plurality of electrode elements of the electrode assembly in the proximal clamping groove 331 of the proximal fixing ring 33, so as to reinforce the fixation of the electrode assembly on the proximal fixing ring 33. The coating layer is made of insulating material, such as insulating tape or coated insulating glue.

[0132] In the present embodiment, the distal end limiting rod 4130 is used to fix the distal end of the ablation electrode element 41 at the distal end of the inner tube 32, as described above, the distal end of the inner tube 32 is sleeved with a distal end fixing ring 34, a plurality of distal end limiting portions are uniformly arranged on the ring body of the distal end fixing ring 34, each distal end limiting portion has a distal end clamping groove 341 for clamping the distal end double rod structure 413, and correspondingly, the distal end of the distal end limiting rod 4130 of the distal end double rod structure 413 has a distal end neck portion 41301 corresponding to the structure of the distal end clamping groove 341, the distal end neck portion 41301 can be clamped in the distal end clamping groove 341 to fix the distal end of the ablation electrode element 41 at the distal end of the inner tube 32. In the present embodiment, the distal end clamping groove 341 includes two wider grooves and a narrower groove between the two wider grooves, and the distal end neck portion 41301 of the distal end limiting rod 4130 is clamped in the narrower groove; preferably, the ring body of the distal end fixing ring 34 is wrapped with a cladding layer for fixing the electrode assembly, the cladding layer wraps the distal end double rod structure 413 of each of the plurality of electrode elements in the electrode assembly in the distal end clamping groove 341 of the distal end fixing ring 34 to reinforce the fixation of the electrode assembly on the distal end fixing ring 34. The cladding layer is made of insulating material, such as insulating tape or coated insulating glue.

[0133] In an embodiment, the two ends of the single rod structure 412 are respectively connected to the proximal end double rod structure 411 and the distal end double rod structure 413, in order to ensure that the single rod structure 412 provides expansion biasing force to the proximal end double rod structure 411 and the distal end double rod structure 413 in the expanded state, in the present embodiment, the proximal end of the single rod structure 412 is connected to the distal end of the first proximal rod 4111, and the distal end of the single rod structure 412 is connected to the proximal end of the second distal rod 4132; of course, in another embodiment, the proximal end of the single rod structure 412 can also be connected to the distal end of the second proximal rod 4112, and correspondingly, the distal end of the single rod structure 412 is connected to the proximal end of the first distal rod 4131.

[0134] In an embodiment, the first proximal rod 4111 and the second proximal rod 4112 are mutually symmetrical rod-shaped structures, specifically, the first proximal rod 4111 and the second proximal rod 4112 are mutually symmetrical curved rods, and the bending direction of the first proximal rod 4111 and the bending direction of the second proximal rod 4112 are in a mirror image relationship. In this embodiment, the first proximal rod 4111 and the second proximal rod 4112 extend towards opposite reverse bending directions after being separated from the distal end of the proximal limiting rod 4110, so as to form a U-shaped structure at the intersection of the first proximal rod 4111 and the second proximal rod 4112 at the intersection of the proximal limiting rod 4110.

[0135] In an embodiment, the first proximal rod 4111 and the second proximal rod 4112 are at a certain angle after being separated from the distal end of the proximal limiting rod 4110, and correspondingly, the first distal rod 4131 and the second distal rod 4132 are also at a certain angle after being separated from the proximal end of the distal limiting rod 4130. In this embodiment, the included angle between the first proximal rod 4111 and the second proximal rod 4112 formed by the bifurcation of the proximal limiting rod 4110 and mutually symmetrical is α, and the included angle between the first distal rod 4131 and the second distal rod 4132 formed by the bifurcation of the distal limiting rod 4130 and mutually symmetrical is β, wherein α≤β, and in a preferred embodiment, angle α< angle β.

[0136] In an embodiment, the included angle between the first proximal rod 4111 and the second proximal rod 4112 formed by the bifurcation of the proximal limiting rod 4110 and mutually symmetrical is α, wherein 10°≤α<120°; or 10°<α≤120°. The included angle is α, and in different embodiments, the included angle α can be selected as: 10°, 12°, 14°, 16°, 18°, 20°, 22°, 24°, 26°, 28°, 30°, 32°, 34°, 36°, 38°, 40°, 42°, 44°, 46°, 48°, 50°, 52°, 54°, 56°, 58°, 60°, 62°, 64°, 66°, 68°, 70°, 72°, 74°, 76°, 78°, 80°, 82°, 84°, 86°, 88°, 90°, 92°, 94°, 96°, 98°, 100°, 102°, 104°, 106°, 108°, 110°, 112°, 114°, 116°, 118°, or 120°.

[0137] In some embodiments, the included angle between the first distal rod 4131 and the second distal rod 4132 diverging from the distal limiting rod 4130 is β, wherein 10°≤β<120°; or 10°<β≤120°. In different embodiments, the included angle β can be selected as 10°, 12°, 14°, 16°, 18°, 20°, 22°, 24°, 26°, 28°, 30°, 32°, 34°, 36°, 38°, 40°, 42°, 44°, 46°, 48°, 50°, 52°, 54°, 56°, 58°, 60°, 62°, 64°, 66°, 68°, 70°, 72°, 74°, 76°, 78°, 80°, 82°, 84°, 86°, 88°, 90°, 92°, 94°, 96°, 98°, 100°, 102°, 104°, 106°, 108°, 110°, 112°, 114°, 116°, 118°, or 120°.

[0138] In one embodiment, the first distal rod 4131 and the second distal rod 4132 are straight rods symmetric to each other. In this embodiment, the first distal rod 4131 and the second distal rod 4132 converge at the intersection of the distal limiting rod 4130 to form a V-shaped structure. In another possible embodiment, the first distal rod 4131 and the second distal rod 4132 converge at the intersection of the distal limiting rod 4130 to form a U-shaped structure.

[0139] In some embodiments, the included angle between the first distal rod 4131 and the second distal rod 4132 diverging from the distal limiting rod 4130 is β, wherein 10°≤β<120°; or 10°<β≤120°. In different embodiments, the included angle β can be selected as 10°, 12°, 14°, 16°, 18°, 20°, 22°, 24°, 26°, 28°, 30°, 32°, 34°, 36°, 38°, 40°, 42°, 44°, 46°, 48°, 50°, 52°, 54°, 56°, 58°, 60°, 62°, 64°, 66°, 68°, 70°, 72°, 74°, 76°, 78°, 80°, 82°, 84°, 86°, 88°, 90°, 92°, 94°, 96°, 98°, 100°, 102°, 104°, 106°, 108°, 110°, 112°, 114°, 116°, 118°, or 120°.

[0140] In some embodiments, the included angle between the first distal rod 4131 and the second distal rod 4132 formed by bifurcating from the distal limiting rod 4130 and symmetric to each other is β, wherein 45°≤β<75°; or 45°<β≤75°. In different embodiments, the included angle of β degrees can be selected as: 45°, 46°, 47°, 48°, 49°, 50°, 51°, 52°, 53°, 54°, 55°, 56°, 57°, 58°, 59°, 60°, 61°, 62°, 63°, 64°, 65°, 66°, 67°, 68°, 69°, 70°, 71°, 72°, 73°, 74°, or 75°.

[0141] In another possible embodiment, the included angle between the first proximal rod 4111 and the second proximal rod 4112 formed by bifurcating from the proximal limiting rod 4110 and symmetric to each other is α, and the included angle between the first distal rod 4131 and the second distal rod 4132 formed by bifurcating from the distal limiting rod 4130 and symmetric to each other is β, wherein α>β.

[0142] In an embodiment, in order to control the expansion state of the plurality of ablation electrode elements 41 in the electrode assembly, the sphericity of the electrode ball can be adjusted by configuring one or more parts of the proximal double rod structure 411, the single rod structure 412, or the distal double rod structure 413 to present different sphericity structures. In an embodiment, the sphericity structure is, for example, the volume of the semi-sphere located at the proximal end is greater than the volume of the semi-sphere located at the distal end; or, the sphericity structure is, for example, the volume of the semi-sphere located at the proximal end is less than the volume of the semi-sphere located at the distal end; or, the sphericity structure is, for example, the volume of the semi-sphere located at the proximal end is equal to the volume of the semi-sphere located at the distal end.

[0143] In an embodiment, the lengths of the first proximal rod 4111 and the second proximal rod 4112 are the same, and the length of the first proximal rod 4111 or the second proximal rod 4112 is less than the length of the single rod structure 412. In another embodiment in which the lengths of the first proximal rod 4111 and the second proximal rod 4112 are the same, the length of the first proximal rod 4111 or the second proximal rod 4112 is equal to the length of the single rod structure 412.

[0144] In an embodiment, the lengths of the first distal rod 4131 and the second distal rod 4132 are the same, and the length of the first distal rod 4131 or the second distal rod 4132 is less than the length of the single rod structure 412. In another embodiment in which the lengths of the first distal rod 4131 and the second distal rod 4132 are the same, the length of the first distal rod 4131 or the second distal rod 4132 is equal to the length of the single rod structure 412.

[0145] As mentioned above, the first proximal rod 4111 and the second proximal rod 4112 have the same length, the first distal rod 4131 and the second distal rod 4132 have the same length, in one embodiment of this example, the length of the first proximal rod 4111 or the second proximal rod 4112 is equal to the length of the first distal rod 4131 or the second distal rod 4132. In another embodiment of this example, the length of the first proximal rod 4111 or the second proximal rod 4112 is less than the length of the first distal rod 4131 or the second distal rod 4132.

[0146] As mentioned above, when the plurality of electrode elements / ablation electrode elements 41 in the electrode assembly are arranged on the distal end of the ablation catheter 30, each two adjacent electrode elements are connected to each other, and therefore, a connection ring 410 is arranged on each ablation electrode element 41 to connect to the adjacent electrode element. In an embodiment, the distal ends of the first proximal rod 4111 and the second proximal rod 4112 of the proximal double rod structure 411 each have a connection ring 410; correspondingly, the proximal ends of the first distal rod 4131 and the second distal rod 4132 of the distal double rod structure 413 each have a connection ring 410. In this embodiment, the connection ring 410 is a circular hole structure integrally formed on the proximal rod or the distal rod, used to connect the proximal rod or the distal rod of other ablation electrode elements 41 by cooperating with the pin / pin member of insulating material.

[0147] In the embodiment in which the proximal end of the single rod structure 412 is connected to the distal end of the first proximal rod 4111, and the distal end of the single rod structure 412 is connected to the proximal end of the second distal rod 4132, the proximal end of the single rod structure 412 shares a connection ring 410 with the distal end of the first proximal rod 4111, and the distal end of the single rod structure 412 shares a connection ring 410 with the proximal end of the second distal rod 4132.

[0148] In the embodiment in which the proximal end of the single rod structure 412 is connected to the distal end of the second proximal rod 4112, and the distal end of the single rod structure 412 is connected to the proximal end of the first distal rod 4131, the proximal end of the single rod structure 412 shares a connection ring 410 with the distal end of the second proximal rod 4112, and the distal end of the single rod structure 412 shares a connection ring 410 with the proximal end of the first distal rod 4131.

[0149] In different embodiments, the opening width formed by the first proximal rod 4111 and the second proximal rod 4112 in the proximal double-rod structure 411 can be the same as or different from the opening width formed by the first distal rod 4131 and the second distal rod 4132 in the distal double-rod structure 413. For example, in one embodiment, the distance between the coupling ring 410 at the distal end of the first proximal rod 4111 and the coupling ring 410 at the distal end of the second proximal rod 4112 in the proximal double-rod structure 411 is G1, and the distance between the coupling ring 410 at the proximal end of the first distal rod 4131 and the coupling ring 410 at the proximal end of the second distal rod 4132 in the distal double-rod structure 413 is G2, where G1>G2. In another embodiment, G1=G2. In yet another embodiment, G1

[0150] In different embodiments, the distance between the proximal double-rod structure 411 and the distal double-rod structure 413 can be configured to different distances. For example, the distance between the proximal double-rod structure 411 and the distal double-rod structure 413 can be represented by the distance between the coupling ring 410 at the distal end of the first proximal rod 4111 in the proximal double-rod structure 411 and the coupling ring 410 at the proximal end of the first distal rod 4131 in the distal double-rod structure 413, or by the distance between the coupling ring 410 at the distal end of the second proximal rod 4112 in the proximal double-rod structure 411 and the coupling ring 410 at the proximal end of the second distal rod 4132 in the distal double-rod structure 413. For example, in the above-mentioned embodiment where the distance between the coupling ring 410 at the distal end of the first proximal rod 4111 and the coupling ring 410 at the distal end of the second proximal rod 4112 in the proximal double-rod structure 411 is G1, and the distance between the coupling ring 410 at the proximal end of the first distal rod 4131 and the coupling ring 410 at the proximal end of the second distal rod 4132 in the distal double-rod structure 413 is G2, the distance between the coupling ring 410 at the distal end of the first proximal rod 4111 in the proximal double-rod structure 411 and the coupling ring 410 at the proximal end of the first distal rod 4131 in the distal double-rod structure 413 is H, where 0

[0151] As shown in the embodiment of FIG. 6, the electrode assembly includes a plurality of electrode elements 41 disposed between the outer tube 31 and the inner tube 32 of the ablation catheter 30, each electrode element 41 including a proximal double-rod structure 411 fixed to the distal end of the outer tube 31, a distal double-rod structure 413 fixed to the distal end of the inner tube 32, and a single-rod structure 412 coupled between the proximal double-rod structure 411 and the distal double-rod structure 413. When the inner tube 32 moves axially relative to the outer tube 31, the electrode assembly is converted between the contracted state and the expanded state. Figure 14 and Figure 15 As shown in the embodiment of FIG. 6, the electrode assembly includes a plurality of electrode elements 41 disposed between the outer tube 31 and the inner tube 32 of the ablation catheter 30, each electrode element 41 including a proximal double-rod structure 411 fixed to the distal end of the outer tube 31, a distal double-rod structure 413 fixed to the distal end of the inner tube 32, and a single-rod structure 412 coupled between the proximal double-rod structure 411 and the distal double-rod structure 413. When the inner tube 32 moves axially relative to the outer tube 31, the electrode assembly is converted between the contracted state and the expanded state.

[0152] In the present application, the single-bar structure 412 of each of the plurality of electrode elements provides a contraction traction force when the electrode assembly is transitioning from the expanded state to the contracted state; and provides an expansion bias force when the electrode assembly is transitioning from the contracted state to the expanded state.

[0153] In an embodiment, the electrode assembly performs energy delivery for treatment of target tissue in the expanded state, and the degree of expansion of the electrode assembly in the expanded state determines the proximity or contact of the electrode elements to the tissue. In practice, when the ablation catheter 30 is delivered to the vicinity of the target tissue, the inner tube 32 is axially moved in the proximal direction to gradually expand the plurality of electrode elements in the electrode assembly from the contracted state to the expanded state, and in the process, the spherical surface of the expanded electrode balloon can help to apply the energy emitted by the plurality of ablation electrode elements 41 to the target tissue in the vicinity of or in contact with the treatment site, and in general, the distal spherical surface formed by the distal double-bar structure 413 of the electrode assembly in the expanded state is in the vicinity of or in contact with the target tissue at the treatment site.

[0154] In some embodiments, the plurality of ablation electrode elements 41 in the electrode assembly can also perform diagnostic functions, such as collecting intracardiac electrocardiogram / electrogram / or monophasic action potential, and performing selective pacing of intracardiac sites for diagnostic purposes. The measured signals can be fed back to the control device, and the plurality of electrode elements in the electrode assembly can also monitor the proximity to the target tissue and the quality of contact with the tissue using impedance-based measurements. One or more measurement elements can also be provided on the electrode assembly. In an embodiment, the measurement element comprises one of a temperature sensor, an impedance sensor, a positioning / location sensor, or an attitude sensor.

[0155] The measurement element can be provided at different locations in the electrode assembly depending on the measurement purpose, such as in an embodiment, the measurement element is provided on the proximal double-bar structure 411 of at least one of the electrode elements in the electrode assembly; such as in another embodiment, the measurement element is provided on the distal double-bar structure 413 of at least one of the electrode elements in the electrode assembly; such as in yet another embodiment, the measurement element is provided on the single-bar structure 412 of at least one of the electrode elements in the electrode assembly.

[0156] In an embodiment, in order to increase the stability of the measurement elements in the fixation of the electrode assembly or not to affect the working state of the ablation electrode elements 41, at least one measurement element is arranged between at least two adjacent electrode elements in the electrode assembly, i.e. each measurement element can be arranged across two adjacent electrode elements, such as in the actual structural design, the fixation of the measurement element can be achieved by means of a suture film or other components or structures, which will be described later.

[0157] In the present application, the electrode group can include any number of electrodes, such as 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20 or more ablation electrode elements 41. In the following embodiments, for example, the number of ablation electrode elements 41 of the electrode assembly is 6. The electrode assembly includes 6 ablation electrode elements 41 composed of proximal double rod structures 411, distal double rod structures 413, and single rod structures 412, wherein each ablation electrode element 41 is connected to two adjacent ablation electrode elements 41 on both sides.

[0158] In an embodiment, the distal end of the first proximal rod 4111 in an electrode element is connected to the distal end of the second proximal rod 4112 in another electrode element on its first side; the distal end of the second proximal rod 4112 in the electrode element is connected to the distal end of the first proximal rod 4111 in another electrode element on its second side. The proximal end of the first distal rod 4131 in an electrode element is connected to the proximal end of the second distal rod 4132 in another electrode element on its first side; the proximal end of the second distal rod 4132 in the electrode element is connected to the proximal end of the first distal rod 4131 in another electrode element on its second side. The proximal end of the single rod structure 412 in an electrode element is connected to the distal end of the second proximal rod 4112 in another electrode element on its first side; the distal end is connected to the proximal end of the first proximal rod 4111 in another electrode element on its second side.

[0159] For example, in the embodiment in which the proximal end of the single rod structure 412 of the electrode element is connected to the distal end of the first proximal rod 4111, and the distal end of the single rod structure 412 is connected to the proximal end of the second distal rod 4132, please refer to Figure 18, the connection between the electrode elements in one embodiment of the electrode assembly of the present application is shown in the figure. For the convenience of explanation of the connection structure between the electrode elements, one electrode element is defined as the intermediate electrode element 41, the electrode element on the first side of the intermediate electrode element 41 is defined as the first electrode element 41', and the electrode element on the second side of the intermediate electrode element 41 is defined as the second electrode element 41". In this embodiment, the distal end of the first proximal rod 4111 in the intermediate electrode element 41 is connected to the distal end of the second proximal rod 4112' of the first electrode element 41'. At the same time, since the distal end of the first proximal rod 4111 in the intermediate electrode element 41 is connected to the proximal end of the single rod structure 412 of the intermediate electrode element 41 through a connection ring 410, the distal end of the second proximal rod 4112' of the first electrode element 41' is also connected to the proximal end of the single rod structure 412 of the intermediate electrode element 41. The distal end of the second proximal rod 4112 in the intermediate electrode element 41 is connected to the distal end of the first proximal rod 4111" of the second electrode element 41". Similarly, since the distal end of the first proximal rod 4111" of the second electrode element 41" is connected to the proximal end of the single rod structure 412" of the second electrode element 41", the distal end of the second proximal rod 4112 in the intermediate electrode element 41 is also connected to the proximal end of the single rod structure 412" of the second electrode element 41". In this connection mode, the proximal end of the second distal rod 4132 in the intermediate electrode element 41 shares a connection ring 410 with the distal end of the single rod structure 412 of the intermediate electrode element 41, and the proximal end of the first distal rod 4131" of the second electrode element 41" is also connected to the connection ring 410 shared by the proximal end of the second distal rod 4132 in the intermediate electrode element 41 and the distal end of the single rod structure 412 of the intermediate electrode element 41. The proximal end of the first distal rod 4131 in the intermediate electrode element 41 is connected to the proximal end of the second distal rod 4132' of the first electrode element 41' and the distal end of the single rod structure 412' of the first electrode element 41'.

[0160] For example, in the embodiment in which the proximal end of the single rod structure 412 is connected to the distal end of the second proximal rod 4112, and the distal end of the single rod structure 412 is connected to the proximal end of the first distal rod 4131, please refer to Figure 19As shown in the figure, for the convenience of illustrating the connection structure between the plurality of electrode elements, one electrode element is defined as the intermediate electrode element 41, the electrode element located at the first side of the intermediate electrode element 41 is defined as the first electrode element 41', and the electrode element located at the second side of the intermediate electrode element 41 is defined as the second electrode element 41". In this embodiment, the distal end of the first proximal rod 4111 in the intermediate electrode element 41 is connected to the distal end of the second proximal rod 4112' of the first electrode element 41', and since the distal end of the second proximal rod 4112' of the first electrode element 41' is connected to the proximal end of the single rod structure 412' of the first electrode element 41', the distal end of the first proximal rod 4111 in the intermediate electrode element 41 is also connected to the proximal end of the single rod structure 412' of the first electrode element 41'; the distal end of the second proximal rod 4112 in the intermediate electrode element 41 is connected to the distal end of the first proximal rod 411" of the second electrode element 41", and the distal end of the second proximal rod 4112 in the intermediate electrode element 41 shares a connection ring 410 with the proximal end of the single rod structure 412 of the intermediate electrode element 41, so the distal end of the first proximal rod 4111" of the second electrode element 41" is also connected to the proximal end of the single rod structure 412 of the intermediate electrode element 41; the proximal end of the first distal rod 4131 in the intermediate electrode element 41 is connected to the proximal end of the second distal rod 4132' of the first electrode element 41', and since the proximal end of the first distal rod 4131 in the intermediate electrode element 41 shares a connection ring 410 with the distal end of the single rod structure 412 of the intermediate electrode element 41, the proximal end of the second distal rod 4132' of the first electrode element 41' is connected to the distal end of the single rod structure 412 of the intermediate electrode element 41; the proximal end of the second distal rod 4132 in the intermediate electrode element 41 is connected to the proximal end of the first distal rod 4131" of the second electrode element 41", and the proximal end of the second distal rod 4132 in the intermediate electrode element 41 is also connected to the distal end of the single rod structure 412" of the second electrode element 41".

[0161] In an embodiment, the electrode assembly further comprises a plurality of insulating members (not shown) for electrically insulating the connection between two different electrode elements. In some embodiments, the insulating members comprise insulating pins, insulating pins, or insulating spacers. The insulating members are, for example, any of various biocompatible polymers, such as polyimide or polyether ether ketone (PEEK) polymers, etc.

[0162] When the inner tube 32 of the ablation catheter 30 is axially moved towards the proximal direction, the distal double-bar structure 413 of each electrode element of the electrode assembly fixed at the distal end of the inner tube 32 is moved towards the proximal direction, while the proximal double-bar structure 411 of each electrode element of the electrode assembly fixed at the distal end of the outer tube 31 remains unchanged. As the inner tube 32 continues to be axially moved towards the proximal direction, the space at both ends of the electrode assembly is compressed, and the single-bar structure 412 of each electrode element provides an expansion biasing force to the proximal double-bar structure 411 and the distal double-bar structure 413. The electrode assembly provided in the present application includes the proximal double-bar structure 411, the distal double-bar structure 413, and the single-bar structure 412. The single-bar structure 412 is arranged at the proximal end and the distal end to provide expansion support. Compared with the traditional mesh electrode ball cage with a complex structure, the electrode assembly of the present application has the stability of the mesh ball cage type electrode and the advantage of easy folding of the strip ball cage type, so that the cardiac pulse ablation electrode can be more easily inserted into the human body, and the structure is stable after being opened in the human body, and the adjacent electrodes will not be miscontacted due to the lack of constraint.

[0163] In addition, the single-bar structure 412 arranged at the proximal end and the distal end to provide expansion support design in the present application makes the pulse ablation electrode more flexible and controllable. When the cardiac pulse ablation electrode is controlled by the inner tube 32, only the fold line part is deformed to increase the shape. Since each electrode element has only one single-bar structure 412 arranged in a fold line type, the force required for deformation is greatly reduced, which is beneficial to the expansion and contraction of the pulse ablation electrode in the human body.

[0164] In the following embodiments, the single electrode element in the electrode assembly is referred to as an ablation electrode element. Please refer to Figure 20 and Figure 21 , Figure 20 a schematic diagram showing the contraction state of the electrode assembly in another embodiment of the present application, Figure 21 a schematic diagram showing the expansion state of the electrode assembly in another embodiment of the present application. As shown in the figure, the ablation electrode element 51 includes a forward branch structure 511, a reverse branch structure 513, and a connecting rod structure 512.

[0165] The forward branch structure 511 is located at the proximal end D1, specifically, the forward branch structure 511 is fixed at the distal end of the outer tube 31 of the ablation catheter 30, correspondingly, the reverse branch structure 513 is located at the distal end D2, specifically, the reverse branch structure 513 is fixed at the distal end of the inner tube 32 of the ablation catheter 30, and the forward branch structure 511 and the reverse branch structure 513 are connected through at least one connecting rod structure 512. Wherein, the forward branch structure 511 and the reverse branch structure 513 move relatively to convert the ablation electrode element 51 between the contracted state and the expanded state, and the at least one connecting rod structure 512 provides a contraction traction force to the forward branch structure 511 and the reverse branch structure 513 in the contracted state or provides an expansion support force to the forward branch structure 511 and the reverse branch structure 513 in the expanded state.

[0166] In this application, the "forward" in the forward branch structure 511 refers to the direction from the proximal end to the distal end; correspondingly, the "forward" in the reverse branch structure 513 refers to the direction from the distal end to the proximal end.

[0167] For example, when the inner tube 32 of the ablation catheter 30 moves axially in the proximal direction, it drives the reverse branch structure 513 of the ablation electrode element 51 fixed at the distal end of the inner tube 32 to also move in the proximal direction, while the position of the forward branch structure 511 fixed at the distal end of the outer tube 31 remains unchanged, at this time the ablation electrode element 51 gradually changes from the contracted state to the expanded state, in this process, the at least one connecting rod structure 512 provides an expansion support force to the forward branch structure 511 and the reverse branch structure 513 in the expanded state, in this embodiment, the expansion support force is a force parallel to the axial direction of the inner tube 32 or the electrode assembly, the two ends of the at least one connecting rod structure 512 are extruded by the reverse branch structure 513 and the forward branch structure 511, the middle part of the at least one connecting rod structure 512 is raised and has a certain arc shape, at the same time, the reverse branch structure 513 and the forward branch structure 511 are driven by the axial movement of the inner tube 32 to a certain extent. raised, until the ablation electrode element 51 reaches the desired expansion degree; correspondingly, when the inner tube 32 of the ablation catheter 30 moves axially in the distal direction, it drives the reverse branch structure 513 of the ablation electrode element 51 fixed at the distal end of the inner tube 32 to also move in the distal direction, while the position of the forward branch structure 511 fixed at the distal end of the outer tube 31 remains unchanged, at this time the ablation electrode element 51 gradually changes from the expanded state to the contracted state, the at least one connecting rod structure 512 provides a contraction traction force to the forward branch structure 511 and the reverse branch structure 513 in the contracted state, until the desired contraction degree is reached.

[0168] In an embodiment, the forward branch structure 511, the reverse branch structure 513, and the at least one connecting rod structure 512 connecting between the forward branch structure 511 and the reverse branch structure 513 of the ablation electrode element 51 are integrally formed structures. The forward branch structure 511, the reverse branch structure 513, and the at least one connecting rod structure 512 of the ablation electrode element 51 are integrally formed structures prepared on a single material by laser cutting or other preparation processes. In a specific embodiment, the material of the ablation electrode element 51 is, for example, nitinol material, and the electrode element can also be coated with one or more of gold, tantalum, iridium oxide, or other materials.

[0169] In an embodiment, the at least one connecting rod structure 512 is a connecting rod with an arc, that is, the connecting rod has an arc in the natural state without force.

[0170] In an embodiment, the forward branch structure 511 is a two-level branch structure; the reverse branch structure 513 is a two-level branch structure. In this embodiment, the two-level branch structure can also be understood as a branch structure after two branches; for the sake of understanding, for example, a main rod is defined as a parent rod, and two or more branch rods formed from the parent rod are defined as child rods, in this state, the branch structure composed of the parent rod and the child rods is a one-level branch structure, and the child rods are further formed into two or more branch rods as grandchild rods, and the branch structure composed of the parent rod, the child rods, and the grandchild rods is a two-level branch structure.

[0171] Please refer to Figure 22 and Figure 24 , Figure 22 Figure 1 shows a first perspective view of an ablation electrode element structure of an electrode assembly in another embodiment of the present application, Figure 23 Figure 2 shows a second perspective view of an ablation electrode element structure of an electrode assembly in another embodiment of the present application, Figure 24 Figure 3 shows a second perspective view of an ablation electrode element structure of an electrode assembly in another embodiment of the present application, as shown, the forward branch structure 511 includes a proximal limiting rod 5110, and a first proximal rod 5111 and a second proximal rod 5112 symmetrically bifurcated forward from the proximal limiting rod 5110, a third proximal rod 5113 and a fifth proximal rod 5115 symmetrically bifurcated forward from the first proximal rod 5111, and a fourth proximal rod 5114 and a sixth proximal rod 5116 symmetrically bifurcated forward from the second proximal rod 5112; wherein the fifth proximal rod 5115 and the sixth proximal rod 5116 are connected.

[0172] In an embodiment where the forward branch structure 511 is a two-level branch structure, the forward branch structure 511 comprises a proximal limiting rod 5110, a first proximal rod 5111, a second proximal rod 5112, a third proximal rod 5113, a fourth proximal rod 5114, a fifth proximal rod 5115, and a sixth proximal rod 5116. The first proximal rod 5111 and the second proximal rod 5112 are formed by forward bifurcation from the proximal limiting rod 5110, and the first proximal rod 5111 and the second proximal rod 5112 are symmetrical to each other. The third proximal rod 5113 and the fifth proximal rod 5115 are formed by forward bifurcation from the first proximal rod 5111, and the third proximal rod 5113 and the fifth proximal rod 5115 are symmetrical to each other. The fourth proximal rod 5114 and the sixth proximal rod 5116 are formed by forward bifurcation from the second proximal rod 5112, and the fourth proximal rod 5114 and the sixth proximal rod 5116 are symmetrical to each other. The distal end of the fifth proximal rod 5115 and the distal end of the sixth proximal rod 5116 are connected. In this embodiment, the first proximal rod 5111, the second proximal rod 5112, the fifth proximal rod 5115, and the sixth proximal rod 5116 form a quadrilateral hole, and the two adjacent sides formed by the first proximal rod 5111 and the second proximal rod 5112 are equal in length, and the two adjacent sides formed by the fifth proximal rod 5115 and the sixth proximal rod 5116 are equal in length.

[0173] In an embodiment, the length of the first proximal rod 5111 or the second proximal rod 5112 of the forward branch structure 511 is greater than the length of the third proximal rod 5113, the fifth proximal rod 5115, the fourth proximal rod 5114, or the sixth proximal rod 5116 of the forward branch structure 511.

[0174] In an embodiment, the first proximal rod 5111, the second proximal rod 5112, the third proximal rod 5113, the fourth proximal rod 5114, the fifth proximal rod 5115, and the sixth proximal rod 5116 of the forward branch structure 511 have the same rod diameter or width, and the rod diameter or width of the proximal limiting rod 5110 of the forward branch structure 511 is greater than the rod diameter or width of the first proximal rod 5111, the second proximal rod 5112, the third proximal rod 5113, the fourth proximal rod 5114, the fifth proximal rod 5115, and the sixth proximal rod 5116.

[0175] In the present application, the proximal end limiting rod 5110 of the forward branch structure 511 is used to fix the proximal end of the ablation electrode element 51 at the distal end of the outer tube 31. In an embodiment, the proximal end of the proximal end limiting rod 5110 of the forward branch structure 511 has a proximal end neck 51101. As described above, the distal end of the outer tube 31 is provided with a proximal end fixing ring 33 in the lumen thereof, and the proximal end fixing ring 33 is uniformly provided with a plurality of proximal end limiting portions on the ring body, each of which has a proximal end clamping groove 331 for clamping the proximal end of the forward branch structure 511. Correspondingly, the proximal end of the proximal end limiting rod 5110 of the forward branch structure 511 has a proximal end neck 51101 corresponding to the structure of the proximal end clamping groove 331, which can be clamped in the proximal end clamping groove 331 to fix the proximal end of the ablation electrode element 51 at the distal end of the outer tube 31. In the present embodiment, the proximal end clamping groove 331 includes two wider grooves and a narrower groove between the two wider grooves, and the proximal end neck 51101 of the proximal end limiting rod 5110 is clamped in the narrower groove. Preferably, the ring body of the proximal end fixing ring 33 is wrapped with a cladding layer for fixing the electrode assembly, and the proximal end limiting rod 5110 of the forward branch structure 511 of each of the plurality of electrode elements in the electrode assembly is clamped in the proximal end clamping groove 331 of the proximal end fixing ring 33 to reinforce the fixation of the electrode assembly on the proximal end fixing ring 33. The cladding layer is made of insulating material, such as insulating tape.

[0176] In an embodiment, the forward branch structure 511 is a one-piece structure. In the present embodiment, the first proximal end rod 5111 and the second proximal end rod 5112 of the forward branch structure 511 are mutually symmetrical rod-shaped structures, specifically, the first proximal end rod 5111 and the second proximal end rod 5112 are mutually symmetrical curved rods, and the bending directions of the first proximal end rod 5111 and the second proximal end rod 5112 are in a mirror image relationship. In the present embodiment, the first proximal end rod 5111 and the second proximal end rod 5112 extend towards opposite reverse bending directions after being separated from the distal end of the proximal end limiting rod 5110 to form a U-shaped structure at the intersection of the first proximal end rod 5111 and the second proximal end rod 5112 at the intersection of the proximal end limiting rod 5110, so as to maintain a certain distance between the first proximal end rod 5111 and the second proximal end rod 5112 after being separated from the distal end of the proximal end limiting rod 5110 to eliminate the mutual influence of the two when being stressed.

[0177] In an embodiment, the first proximal rod 5111 and the second proximal rod 5112 are separated from the distal end of the proximal limiting rod 5110 at an angle, in this embodiment, the included angle between the first proximal rod 5111 and the second proximal rod 5112 which are branched from the proximal limiting rod 5110 and symmetric to each other is a, wherein 10°≤a<120°; or 10°<a≤120°. The included angle a, in different embodiments, the included angle a can be selected as: 10°, 12°, 14°, 16°, 18°, 20°, 22°, 24°, 26°, 28°, 30°, 32°, 34°, 36°, 38°, 40°, 42°, 44°, 46°, 48°, 50°, 52°, 54°, 56°, 58°, 60°, 62°, 64°, 66°, 68°, 70°, 72°, 74°, 76°, 78°, 80°, 82°, 84°, 86°, 88°, 90°, 92°, 94°, 96°, 98°, 100°, 102°, 104°, 106°, 108°, 110°, 112°, 114°, 116°, 118°, or 120°.

[0178] In some embodiments, the included angle between the first proximal rod 5111 and the second proximal rod 5112 which are branched from the proximal limiting rod 5110 and symmetric to each other is a, wherein 15°≤a<45°; or 15°<a≤45°. In different embodiments, the included angle a can be selected as: 15°, 16°, 17°, 18°, 19°, 20°, 21°, 22°, 23°, 24°, 25°, 26°, 27°, 28°, 29°, 30°, 31°, 32°, 33°, 34°, 35°, 36°, 37°, 38°, 39°, 40°, 41°, 42°, 43°, 44°, or 45°.

[0179] The reverse branch structure 513 includes a distal limiting rod 5130, and a first distal rod 5131 and a second distal rod 5132 which are branched from the distal limiting rod 5130 in reverse and symmetric to each other, a third distal rod 5133 and a fifth distal rod 5135 which are branched from the first distal rod 5131 in reverse and symmetric to each other, and a fourth distal rod 5134 and a sixth distal rod which are branched from the second distal rod 5132 in reverse; wherein the fifth distal rod 5135 and the sixth distal rod are connected at the intersection.

[0180] In an embodiment where the reverse branch structure 513 is a two-level branch structure, the reverse branch structure 513 comprises a distal limiting rod 5130, a first distal rod 5131, a second distal rod 5132, a third distal rod 5133, a fourth distal rod 5134, a fifth distal rod 5135, and a sixth distal rod 5136. The first distal rod 5131 and the second distal rod 5132 are formed by reverse branching from the distal limiting rod 5130, and the first distal rod 5131 and the second distal rod 5132 are symmetrical to each other. The third distal rod 5133 and the fifth distal rod 5135 are formed by reverse branching from the first distal rod 5131, and the third distal rod 5133 and the fifth distal rod 5135 are symmetrical to each other. The fourth distal rod 5134 and the sixth distal rod 5136 are formed by reverse branching from the second distal rod 5132, and the fourth distal rod 5134 and the sixth distal rod 5136 are symmetrical to each other. The proximal end of the fifth distal rod 5135 and the proximal end of the sixth distal rod 5136 are connected.

[0181] In an embodiment, the first distal rod 5131, the second distal rod 5132, the third distal rod 5133, the fifth distal rod 5135, the fourth distal rod 5134, and the sixth distal rod 5136 of the reverse branch structure 513 have the same length. Then, the quadrilateral composed of the first distal rod 5131, the second distal rod 5132, the fifth distal rod 5135, and the sixth distal rod 5136 is an equilateral quadrilateral.

[0182] In an embodiment, the first distal rod 5131, the second distal rod 5132, the third distal rod 5133, the fourth distal rod 5134, the fifth distal rod 5135, and the sixth distal rod 5136 of the reverse branch structure 513 have the same rod diameter or width, and the rod diameter or width of the distal limiting rod 5130 of the reverse branch structure 513 is greater than the rod diameter or width of the first distal rod 5131, the second distal rod 5132, the third distal rod 5133, the fourth distal rod 5134, the fifth distal rod 5135, and the sixth distal rod 5136.

[0183] In the present embodiment, the distal end limiting rod 5130 is used to fix the reverse branch structure 513 of the ablation electrode element 51 at the distal end of the inner tube 32, as described above, the distal end of the inner tube 32 is sleeved with a distal end fixing ring 34, a plurality of distal end limiting portions are uniformly arranged on the ring body of the distal end fixing ring 34, each distal end limiting portion has a distal end clamping groove 341 for clamping the distal end limiting rod 5130 of the reverse branch structure 513, and correspondingly, the distal end of the distal end limiting rod 5130 of the reverse branch structure 513 has a distal end neck portion 51301 corresponding to the structure of the distal end clamping groove 341, the distal end neck portion 51301 can be clamped in the distal end clamping groove 341 to fix the distal end of the ablation electrode element 51 at the distal end of the inner tube 32. In the present embodiment, the distal end clamping groove 341 includes two wider grooves and a narrower groove between the two wider grooves, and the distal end neck portion 51301 of the distal end limiting rod 5130 is clamped in the narrower groove; preferably, the ring body of the distal end fixing ring 34 is wrapped with a cladding layer for fixing the distal end limiting rod 5130 of the reverse branch structure 513, the cladding layer wraps the distal end limiting rod 5130 of each electrode element in the distal end clamping groove 341 of the distal end fixing ring 34 of the electrode assembly to reinforce the fixation of the electrode assembly on the distal end fixing ring 34. The cladding layer is made of insulating material, such as insulating tape.

[0184] In an embodiment, the reverse branch structure 513 is a one-piece structure. In the present embodiment, the first distal end rod 5131 and the second distal end rod 5132 of the reverse branch structure 513 are mutually symmetrical straight rods. In the present embodiment, the first distal end rod 5131 and the second distal end rod 5132 intersect at the intersection of the distal end limiting rod 5130 to form a V-shaped structure. In another possible embodiment, the first distal end rod 5131 and the second distal end rod 5132 intersect at the intersection of the distal end limiting rod 5130 to form a U-shaped structure.

[0185] In some embodiments, the included angle between the first distal rod 5131 and the second distal rod 5132 which are formed by the bifurcation of the distal limiting rod 5130 and symmetric to each other is β, wherein 10°≤β<120°; or 10°<β≤120°. In different embodiments, the included angle of β degrees can be selected as: 10°, 12°, 14°, 16°, 18°, 20°, 22°, 24°, 26°, 28°, 30°, 32°, 34°, 36°, 38°, 40°, 42°, 44°, 46°, 48°, 50°, 52°, 54°, 56°, 58°, 60°, 62°, 64°, 66°, 68°, 70°, 72°, 74°, 76°, 78°, 80°, 82°, 84°, 86°, 88°, 90°, 92°, 94°, 96°, 98°, 100°, 102°, 104°, 106°, 108°, 110°, 112°, 114°, 116°, 118°, or 120°.

[0186] In some embodiments, the included angle between the first distal rod 5131 and the second distal rod 5132 which are formed by the bifurcation of the distal limiting rod 5130 and symmetric to each other is β, wherein 45°≤β<75°; or 45°<β≤75°. In different embodiments, the included angle of β degrees can be selected as: 45°, 46°, 47°, 48°, 49°, 50°, 51°, 52°, 53°, 54°, 55°, 56°, 57°, 58°, 59°, 60°, 61°, 62°, 63°, 64°, 65°, 66°, 67°, 68°, 69°, 70°, 71°, 72°, 73°, 74°, or 75°.

[0187] In another possible embodiment, the included angle between the first proximal rod 5111 and the second proximal rod 5112 which are formed by the bifurcation of the proximal limiting rod 5110 and symmetric to each other is α, and the included angle between the first distal rod 5131 and the second distal rod 5132 which are formed by the bifurcation of the distal limiting rod 5130 and symmetric to each other is β, such as in an embodiment, α<β; in another embodiment, α=β; or in still another embodiment, α>β.

[0188] In an embodiment, in order to control the expansion state of the plurality of ablation electrode elements 51 in the electrode assembly, the sphericity of the electrode ball can be adjusted by configuring one or more portions of the forward branch structure 511, the link structure 512, or the reverse branch structure 513 to exhibit different sphericity. In an embodiment, the sphericity is such that the volume of the hemisphere at the proximal end is greater than the volume of the hemisphere at the distal end; alternatively, the sphericity is such that the volume of the hemisphere at the proximal end is less than the volume of the hemisphere at the distal end; or alternatively, the sphericity is such that the volume of the hemisphere at the proximal end is equal to the volume of the hemisphere at the distal end.

[0189] In an embodiment, the first proximal rod 5111, the second proximal rod 5112, the fifth proximal rod 5115, and the sixth proximal rod 5116 define a first quadrilateral hole; the first distal rod 5131, the second distal rod 5132, the fifth distal rod 5135, and the sixth distal rod 5136 define a second quadrilateral hole; in this embodiment, the first quadrilateral hole is larger than the second quadrilateral hole.

[0190] In this embodiment, the proximal limit rod 5110 of the forward branch structure 511 and the distal limit rod 5130 of the reverse branch structure 513 are located on the same axis line. It should be understood that the axis line described here is only the axis line from the perspective of a single ablation electrode element 51, and it can also be understood that the proximal limit rod 5110 of the forward branch structure 511 and the distal limit rod 5130 of the reverse branch structure 513 are located on the same straight line.

[0191] As described above, when the plurality of electrode elements / ablation electrode elements 51 in the electrode assembly are arranged on the distal end of the ablation catheter 30, each two adjacent electrode elements are connected to each other, and therefore, each ablation electrode element 51 is provided with a connection ring 510 for connecting to an adjacent electrode element. In an embodiment, the distal end of the third proximal rod 5113 and / or the proximal end of the third distal rod 5133 has a connection ring 510 for connecting to another ablation electrode element 51; the distal end of the fourth proximal rod 5114 and / or the proximal end of the fourth distal rod 5134 has a connection ring 510 for connecting to another ablation electrode element 51. In this embodiment, the connection ring 510 is a circular hole structure integrally formed on the proximal rod or the distal rod, which is used to connect the proximal rod or the distal rod of another ablation electrode element 51 by means of a pin / pin member of insulating material.

[0192] In different embodiments, the spacing between the forward branch structure 511 and the reverse branch structure 513 can be configured to different distances, for example, the spacing between the connecting ring 510 at the distal end of the third proximal rod 5113 and the connecting ring 510 at the proximal end of the third distal rod 5133 is L; in an embodiment, the spacing between the connecting ring 510 at the distal end of the fourth proximal rod 5114 and the connecting ring 510 at the proximal end of the fourth distal rod 5134 is L; accordingly, the spacing between the connecting ring 510 at the distal end of the third proximal rod 5113 and the connecting ring 510 at the proximal end of the third distal rod 5133 is L; wherein 0mm≤L<15mm.

[0193] In a specific embodiment, when the spacing L=0mm, it means that the distal end of the fourth proximal rod 5114 and the proximal end of the fourth distal rod 5134 share a connecting ring 510; the distal end of the third proximal rod 5113 and the proximal end of the third distal rod 5133 share a connecting ring 510.

[0194] In different embodiments, the single-link structure 512 connecting the forward branch structure 511 and the reverse branch structure 513 can also be connected by a double-link structure 512, and can also be connected by a three-link structure 512.

[0195] In some embodiments, the link structure connecting the forward branch structure and the reverse branch structure is a single central link. In an embodiment, the central link is located on the central axis of the ablation electrode element, that is, the central link, the proximal limiting rod and the distal limiting rod are on the same central axis, specifically, the proximal end of the central link is connected to the intersection of the fifth proximal rod and the sixth proximal rod; the distal end of the central link is connected to the intersection of the fifth distal rod and the sixth distal rod.

[0196] Please refer to Figure 25, shows a structural schematic diagram of the ablation electrode element with a single center link in an embodiment of the present application. As shown in the figure, in the above-mentioned one embodiment of the single center link structure 512, the distal end of the third proximal rod 5113 is connected to the proximal end of the third distal rod 5133; the distal end of the fourth proximal rod 5114 is connected to the proximal end of the fourth distal rod 5134; specifically, the distance between the connecting ring 510 at the distal end of the fourth proximal rod 5114 and the connecting ring 510 at the proximal end of the fourth distal rod 5134 is L; correspondingly, the distance between the connecting ring 510 at the distal end of the third proximal rod 5113 and the connecting ring 510 at the proximal end of the third distal rod 5133 is L; in the case of L = 0 mm, it means that the distal end of the fourth proximal rod 5114 and the proximal end of the fourth distal rod 5134 share a connecting ring 510; the distal end of the third proximal rod 5113 and the proximal end of the third distal rod 5133 share a connecting ring 510.

[0197] In the present embodiment, the intersection of the third proximal rod 5113 and the third distal rod 5133 has a connecting ring 510 for connecting another ablation electrode element 51; the intersection of the fourth proximal rod 5114 and the fourth distal rod 5134 has a connecting ring 510 for connecting still another ablation electrode element 51. In other words, the third proximal rod 5113 and the third distal rod 5133 share one connecting ring 510 at the intersection; the fourth proximal rod 5114 and the fourth distal rod 5134 share one connecting ring 510 at the intersection. In the present embodiment, the third proximal rod 5113, the fifth proximal rod 5115, the center link 5120, the fifth distal rod 5135, and the third distal rod 5133 form a first pentagonal hole; the fourth proximal rod 5114, the sixth proximal rod 5116, the center link 5120, the sixth distal rod 5136, and the fourth distal rod 5134 form a second pentagonal hole; the shape and size of the first pentagonal hole are equivalent to those of the second pentagonal hole.

[0198] Please refer to Figure 26, as shown in the figure, in another embodiment of the above-mentioned single central link structure 512, the distal end of the third proximal link 5113 is not directly connected with the proximal end of the third distal link 5133, and has a spacing L; the distal end of the fourth proximal link 5114 is not directly connected with the proximal end of the fourth distal link 5134, and has a spacing L; and in the case of the above-mentioned spacing L > 0 mm, it means that the distal end of the fourth proximal link 5114 and the proximal end of the fourth distal link 5134 each have a connecting ring 510 for connecting another electrode element; the distal end of the third proximal link 5113 and the proximal end of the third distal link 5133 each have a connecting ring 510 for connecting another electrode element. In this embodiment, the first proximal link 5111, the second proximal link 5112, the fifth proximal link 5115, and the sixth proximal link 5116 surround to form a quadrilateral hole; correspondingly, the first distal link 5131, the second distal link 5132, the fifth distal link 5135, and the sixth distal link 5136 surround to form a quadrilateral hole.

[0199] In some embodiments, the link structure 512 connected between the forward branch structure 511 and the reverse branch structure 513 is a double-link structure including a central link and a side link. In these embodiments, the side link can be selected as a left side link or a right side link, which should be understood as a relative concept for facilitating the description herein.

[0200] In the above-mentioned embodiment of the double-link structure 512, the central link 5120 is located on the central axis of the ablation electrode element 51, i.e. the central link 5120, the proximal limiting rod 5110, and the distal limiting rod 5130 are all on the same central axis, specifically, the proximal end of the central link 5120 is connected at the intersection of the fifth proximal link 5115 and the sixth proximal link 5116; the distal end of the central link 5120 is connected at the intersection of the fifth distal link 5135 and the sixth distal link 5136.

[0201] In this embodiment, the first proximal link 5111, the second proximal link 5112, the fifth proximal link 5115, and the sixth proximal link 5116 surround to form a first quadrilateral hole; the first distal link 5131, the second distal link 5132, the fifth distal link 5135, and the sixth distal link 5136 surround to form a second quadrilateral hole; wherein the first quadrilateral hole is larger than the second quadrilateral hole.

[0202] Please refer to Figure 27, shows a structural schematic diagram of the ablation electrode element with double-link structure in an embodiment of the present application. As shown in the figure, in this example, the proximal end of the side link 5121 is connected to the third proximal link 5113, and the distal end of the side link 5121 is connected to the third distal link 5133; that is, the proximal end of the side link 5121 shares a connection ring 510 with the distal end of the third proximal link 5113, and the distal end of the side link 5121 shares a connection ring 510 with the proximal end of the third distal link 5133. Then the third proximal link 5113, the fifth proximal link 5115, the center link 5120, the fifth distal link 5135, and the sixth distal link 5136 form a hexagonal hole.

[0203] Please refer to Figure 28 , shows a structural schematic diagram of the ablation electrode element with double-link structure in another embodiment of the present application. As shown in the figure, in this example, the proximal end of the side link 5121 is connected to the fourth proximal link 5114, and the distal end of the side link 5121 is connected to the fourth distal link 5134. That is, the proximal end of the side link 5121 shares a connection ring 510 with the distal end of the fourth proximal link 5114, and the distal end of the side link 5121 shares a connection ring 510 with the proximal end of the fourth distal link 5134. Then the fourth proximal link 5114, the sixth proximal link 5116, the center link 5120, the sixth distal link 5136, and the fourth distal link 5134 form a hexagonal hole.

[0204] In the above-mentioned embodiment in which the link structure 512 is double-link, the length of the center link 5120 is greater than the length of the side link 5121.

[0205] Please refer to Figure 29 , shows a structural schematic diagram of the ablation electrode element with triple-link structure in an embodiment of the present application. As shown in the figure, in this embodiment, the link structure 512 between the forward branch structure 511 and the reverse branch structure 513 is a triple-link structure including a center link 5120, a first side link 5121, and a second side link 5122. The center link 5120 is located on the central axis of the ablation electrode element 51, the proximal end of the center link 5120 is connected to the intersection of the fifth proximal link 5115 and the sixth proximal link 5116, the distal end of the center link 5120 is connected to the intersection of the fifth distal link 5135 and the sixth distal link 5136, the proximal end of the first side link 5121 is connected to the third proximal link 5113, and the distal end of the first side link 5121 is connected to the third distal link 5133; the proximal end of the second side link 5122 is connected to the fourth proximal link 5114, and the distal end of the second side link 5122 is connected to the fourth distal link 5134.

[0206] In an embodiment, the length of the first side link 5121 is equal to the length of the second side link 5122; the length of the center link 5120 is greater than the length of the first side link 5121 or the length of the second side link 5122.

[0207] In the embodiment of the above-mentioned three-link structure 512, the center link 5120 is located on the central axis of the ablation electrode element 51, that is, the center link 5120, the proximal limiting rod 5110, and the distal limiting rod 5130 are all on the same central axis. Specifically, the proximal end of the center link 5120 is connected to the intersection of the fifth proximal rod 5115 and the sixth proximal rod 5116; the distal end of the center link 5120 is connected to the intersection of the fifth distal rod 5135 and the sixth distal rod 5136.

[0208] In the embodiment, the first proximal rod 5111, the second proximal rod 5112, the fifth proximal rod 5115, and the sixth proximal rod 5116 form a first quadrilateral hole; the first distal rod 5131, the second distal rod 5132, the fifth distal rod 5135, and the sixth distal rod 5136 form a second quadrilateral hole; and the first quadrilateral hole is larger than the second quadrilateral hole.

[0209] In the embodiment, the third proximal rod 5113, the fifth proximal rod 5115, the center link 5120, the fifth distal rod 5135, and the sixth distal rod 5136 form a first hexagonal hole; the fourth proximal rod 5114, the sixth proximal rod 5116, the center link 5120, the sixth distal rod 5136, and the fourth distal rod 5134 form a second hexagonal hole; and the first hexagonal hole is equal in shape and size to the second hexagonal hole.

[0210] In an embodiment, the proximal end portion and the distal end portion of the first side link 5121 each has a connecting ring 510 for connecting another ablation electrode element 51; that is, the proximal end of the first side link 5121 shares one connecting ring 510 with the distal end of the third proximal rod 5113, and the distal end of the first side link 5121 shares one connecting ring 510 with the proximal end of the third distal rod 5133 for connecting another ablation electrode element 51; the proximal end portion and the distal end portion of the second side link 5122 each has a connecting ring 510 for connecting another ablation electrode element 51; that is, the proximal end of the second side link 5122 shares one connecting ring 510 with the distal end of the fourth proximal rod 5114, and the distal end of the second side link 5122 shares one connecting ring 510 with the proximal end of the fourth distal rod 5134 for connecting another ablation electrode element 51.

[0211] As described above, when the plurality of electrode elements / ablation electrode elements 51 in the electrode assembly are arranged on the distal end of the ablation catheter 30, each two adjacent electrode elements are connected to each other, and therefore, a connection ring 510 is arranged on each ablation electrode element 51 to connect the adjacent electrode elements. In order to ensure better connection of the two adjacent electrode elements at the connection ring 510, the proximal end portion and the distal end portion of the first side link 5121 are respectively provided with a bending structure, and the proximal end portion and the distal end portion of the second side link 5122 are respectively provided with a bending structure. When the connection ring 510 on the first side link of one electrode element and the second side link of another electrode element are fixed by a fixing member such as an insulating pin, the bending directions of the two bending structures are opposite to each other, and the connection ring 510 is in an intersecting state. In another embodiment, the bending structure can also be formed on the distal end of the first proximal link 5111 and the proximal end of the first distal link 5131, and the bending structure can also be formed on the distal end of the fourth proximal link 5114 and the proximal end of the fourth distal link 5134.

[0212] As shown in the above Figure 20 and Figure 21 embodiments, the electrode assembly includes a plurality of electrode elements arranged between the outer tube 31 and the inner tube 32, each electrode element including a forward branch structure 511 fixed to the distal end of the outer tube 31 and a reverse branch structure 513 fixed to the distal end of the inner tube 32, and at least one link structure 512 connected between the forward branch structure 511 and the reverse branch structure 513; wherein the inner tube 32 moves axially relative to the outer tube 31 to drive the electrode assembly to switch between the contracted state and the expanded state.

[0213] In the present application, the forward branch structure 511 and the reverse branch structure 513 of each electrode element of the plurality of electrode elements of the electrode assembly move relative to each other to switch the ablation electrode element 51 between the contracted state and the expanded state, and the at least one link structure 512 provides a contraction traction force to the forward branch structure 511 and the reverse branch structure 513 in the contracted state or provides an expansion support force to the forward branch structure 511 and the reverse branch structure 513 in the expanded state.

[0214] In an embodiment, the electrode assembly performs energy release in the expanded state to treat target tissue, and the degree of expansion of the electrode assembly in the expanded state determines the contact or proximity of each electrode element to the tissue. In actual application, when the electrode tissue is delivered to the vicinity of the target tissue by the ablation catheter 30, the operation of the inner tube 32 is axially moved in the proximal direction to gradually expand the plurality of electrode elements in the electrode assembly from the contracted state to the expanded state. In this process, the spherical surface orientation of the expanded electrode ball can help the energy emitted by the plurality of ablation electrode elements 51 to be applied to the target tissue in the vicinity of the treatment site or to be in contact with the target tissue. Generally, when the electrode assembly is expanded into an electrode ball, the distal spherical surface formed by the distal structure thereof approaches or contacts the target tissue at the treatment site.

[0215] In some embodiments, the plurality of ablation electrode elements 51 in the electrode assembly can also perform a diagnostic function, such as collecting intracardiac electrocardiogram / electrogram or monophasic action potential and performing selective pacing of intracardiac sites for diagnostic purposes. The measured signals can be fed back to the control device, and the plurality of electrode elements in the electrode assembly can also monitor the proximity to the target tissue and the quality of contact with the tissue using impedance-based measurements. One or more measurement elements are also provided on the electrode assembly. In an embodiment, the measurement element includes one of a temperature sensor, an impedance sensor, a positioning / position sensor, or an attitude sensor.

[0216] Based on different measurement purposes, the measurement elements can be arranged at different positions in the electrode assembly. For example, in an embodiment, at least one measurement element is arranged on the forward branch structure 511, the reverse branch structure 513, or the at least one connecting rod structure 512 of at least one electrode element in the electrode assembly. For example, in an embodiment, the measurement element is arranged on the forward branch structure 511 of at least one electrode element in the electrode assembly; for example, in another embodiment, the measurement element is arranged on the reverse branch structure 513 of at least one electrode element in the electrode assembly; for example, in still another embodiment, the measurement element is arranged on the connecting rod structure 512 of at least one electrode element in the electrode assembly.

[0217] In an embodiment, in order to increase the stability of the measurement element in the fixation of the electrode assembly or not to affect the working state of the ablation electrode element 51, at least one measurement element is arranged between at least two adjacent electrode elements in the electrode assembly, i.e., each measurement element can be arranged across the position between two adjacent electrode elements. For example, in actual structural design, the fixation of the measurement element can be achieved by a suture film or other components or structures, which will be described in detail later.

[0218] In the present application, the set of electrodes can include any number of electrodes, such as 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20 or more ablation electrode elements 51. In the following embodiments, the number of ablation electrode elements 51 of the electrode assembly is taken as an example of 6. The electrode assembly includes 6 ablation electrode elements 51 composed of a forward branch structure 511, a reverse branch structure 513, or at least one connecting rod structure 512, wherein each ablation electrode element 51 is connected with two ablation electrode elements 51 adjacent to both sides.

[0219] In an embodiment, the electrode assembly further includes a plurality of insulating members for achieving electrical insulation between two different electrode elements at the connection between the two different electrode elements, and in some embodiments, the insulating members include insulating pins, insulating pins, or insulating gaskets. The insulating members are, for example, any of a variety of biocompatible polymers, such as polyimide or polyether ether ketone (PEEK) polymers, etc.

[0220] As described above Figure 25 As shown in the above embodiment in which the connecting rod structure 512 is a single central connecting rod 5120, the distal end of the third proximal rod 5113 is connected to the proximal end of the third distal rod 5133; the distal end of the fourth proximal rod 5114 is connected to the proximal end of the fourth distal rod 5134; in particular, the spacing between the connection ring 510 at the distal end of the fourth proximal rod 5114 and the connection ring 510 at the proximal end of the fourth distal rod 5134 is L; accordingly, the spacing between the connection ring 510 at the distal end of the third proximal rod 5113 and the connection ring 510 at the proximal end of the third distal rod 5133 is L; in the case where the spacing L = 0 mm, it means that the distal end of the fourth proximal rod 5114 and the proximal end of the fourth distal rod 5134 share a connection ring 510; the distal end of the third proximal rod 5113 and the proximal end of the third distal rod 5133 share a connection ring 510.

[0221] In the present embodiment, when assembling a plurality of electrode elements into an electrode assembly, please refer to Figure 30, as shown in the figure, for the convenience of explaining the connection structure between the plurality of electrode elements, one electrode element is defined as the intermediate electrode element 51, the electrode element located at the first side of the intermediate electrode element 51 is defined as the first electrode element 51', and the electrode element located at the second side of the intermediate electrode element 51 is defined as the second electrode element 51". In this embodiment, the third proximal rod 5113 of the intermediate electrode element 51 and the fourth proximal rod 5114' of the first electrode element 51' are connected to each other, the third distal rod 5133 of the intermediate electrode element 51 and the fourth distal rod 5134' of the first electrode element 51' are connected to each other, the fourth proximal rod 5114 of the intermediate electrode element 51 and the third proximal rod 5113" of the second electrode element 51" are connected to each other, and the fourth distal rod 5134 of the intermediate electrode element 51 and the third distal rod 5133" of the second electrode element 51" are connected to each other.

[0222] as shown above Figure 26 In another embodiment of the above-mentioned single central link 5120, the distal end of the third proximal rod 5113 and the proximal end of the third distal rod 5133 are not directly connected and have a spacing L, and the distal end of the fourth proximal rod 5114 and the proximal end of the fourth distal rod 5134 are not directly connected and have a spacing L. When the above-mentioned spacing L > 0 mm, it means that the distal end of the fourth proximal rod 5114 and the proximal end of the fourth distal rod 5134 each have a connection ring 510 for connecting another electrode element, and the distal end of the third proximal rod 5113 and the proximal end of the third distal rod 5133 each have a connection ring 510 for connecting another electrode element.

[0223] In this embodiment, when assembling a plurality of electrode elements into an electrode assembly, please refer to Figure 31 , as shown in the figure, for the convenience of explaining the connection structure between the plurality of electrode elements, one electrode element is defined as the intermediate electrode element 51, the electrode element located at the first side of the intermediate electrode element 51 is defined as the first electrode element 51', and the electrode element located at the second side of the intermediate electrode element 51 is defined as the second electrode element 51". In this embodiment, the third proximal rod 5113 of the intermediate electrode element 51 and the fourth proximal rod 5114' of the first electrode element 51' are connected to each other, the third distal rod 5133 of the intermediate electrode element 51 and the fourth distal rod 5134' of the first electrode element 51' are connected to each other, the fourth proximal rod 5114 of the intermediate electrode element 51 and the third proximal rod 5113" of the second electrode element 51" are connected to each other, and the fourth distal rod 5134 of the intermediate electrode element 51 and the third distal rod 5133" of the second electrode element 51" are connected to each other.

[0224] as shown aboveFigure 27 As shown, in the embodiment of the above-mentioned double-link structure 512, the center link 5120 is located on the central axis of the ablation electrode element 51, i.e. the center link 5120, the proximal limiting rod 5110 and the distal limiting rod 5130 are all on the same central axis, specifically, the proximal end of the center link 5120 is connected to the intersection of the fifth proximal rod 5115 and the sixth proximal rod 5116; the distal end of the center link 5120 is connected to the intersection of the fifth distal rod 5135 and the sixth distal rod 5136. The proximal end of the side link 5121 is connected to the third proximal rod 5113, and the distal end of the side link 5121 is connected to the third distal rod 5133; i.e. the proximal end of the side link 5121 and the distal end of the third proximal rod 5113 share a connecting ring 510, and the distal end of the side link 5121 and the proximal end of the third distal rod 5133 share a connecting ring 510.

[0225] Please refer to Figure 32 , which shows the combination of electrode elements in another embodiment of the electrode assembly in the present application. As shown, in this embodiment, when assembling multiple electrode elements into an electrode assembly, for the convenience of explaining the connection structure between multiple electrode elements, one electrode element is still defined as the intermediate electrode element 51, the electrode element located on the first side of the intermediate electrode element 51 is defined as the first electrode element 51', and the electrode element located on the second side of the intermediate electrode element 51 is defined as the second electrode element 51". In this embodiment, the distal end of the third proximal rod 5113 of the intermediate electrode element 51, the proximal end of the side link 5121 of the intermediate electrode element 51, and the distal end of the fourth proximal rod 5114' of the first electrode element 51' are connected to each other; the proximal end of the third distal rod 5133 of the intermediate electrode element 51, the distal end of the side link 5121 of the intermediate electrode element 51, and the proximal end of the fourth distal rod 5134' of the first electrode element 51' are connected to each other; the distal end of the fourth proximal rod 5114 of the intermediate electrode element 51, the distal end of the third proximal rod 5113 of the second electrode element 51", and the proximal end of the side link 5121" of the second electrode element 51" are connected to each other; the proximal end of the fourth distal rod 5134 of the intermediate electrode element 51, the proximal end of the third distal rod 5133" of the second electrode element 51", and the distal end of the side link 5121" of the second electrode element 51" are connected to each other.

[0226] As described above Figure 28As shown, in another embodiment of the above-mentioned double-link structure 512, the center link 5120 is located on the central axis of the ablation electrode element 51, i.e. the center link 5120, the proximal limiting rod 5110 and the distal limiting rod 5130 are all on the same central axis, specifically, the proximal end of the center link 5120 is connected to the intersection of the fifth proximal rod 5115 and the sixth proximal rod 5116; the distal end of the center link 5120 is connected to the intersection of the fifth distal rod 5135 and the sixth distal rod 5136. The proximal end of the side link 5121 is connected to the fourth proximal rod 5114, and the distal end of the side link 5121 is connected to the fourth distal rod 5134. That is, the proximal end of the side link 5121 and the distal end of the fourth proximal rod 5114 share a connecting ring 510, and the distal end of the side link 5121 and the proximal end of the fourth distal rod 5134 share a connecting ring 510.

[0227] Referring to Figure 33 , which shows the combination of electrode elements in another embodiment of the electrode assembly in the present application. As shown, in this embodiment, when assembling multiple electrode elements into an electrode assembly, for the convenience of explaining the connection structure between multiple electrode elements, one electrode element is still defined as the intermediate electrode element 51, the electrode element located on the first side of the intermediate electrode element 51 is defined as the first electrode element 51', and the electrode element located on the second side of the intermediate electrode element 51 is defined as the second electrode element 51". In this embodiment, the distal end of the third proximal rod 5113 of the intermediate electrode element 51, the distal end of the fourth proximal rod 5114' of the first electrode element 51', and the proximal end of the side link 5121' of the first electrode element 51' are connected to each other; the proximal end of the third distal rod 5133 of the intermediate electrode element 51, the proximal end of the fourth distal rod 5134' of the first electrode element 51', and the distal end of the side link 5121' of the first electrode element 51' are connected to each other; the distal end of the fourth proximal rod 5114 of the intermediate electrode element 51, the proximal end of the side link 5121 of the intermediate electrode element 51, and the distal end of the third proximal rod 5113" of the second electrode element 51" are connected to each other; the proximal end of the fourth distal rod 5134 of the intermediate electrode element 51, the distal end of the side link 5121 of the intermediate electrode element 51, and the proximal end of the third distal rod 5133" of the second electrode element 51" are connected to each other;

[0228] As described above Figure 29As shown, in the above embodiment of the three-linkage linkage structure 512, the linkage structure 512 connecting between the forward branch structure 511 and the reverse branch structure 513 is a three-linkage linkage structure including a center linkage 5120, and a first side linkage 5121, and a second side linkage 5122. The center linkage 5120 is located on the central axis of the ablation electrode element 51, the proximal end of the center linkage 5120 is connected to the intersection of the fifth proximal rod 5115 and the sixth proximal rod 5116; the distal end of the center linkage 5120 is connected to the intersection of the fifth distal rod 5135 and the sixth distal rod 5136; the proximal end of the first side linkage 5121 is connected to the third proximal rod 5113, and the distal end of the first side linkage 5121 is connected to the third distal rod 5133; the proximal end of the second side linkage 5122 is connected to the fourth proximal rod 5114, and the distal end of the second side linkage 5122 is connected to the fourth distal rod 5134.

[0229] Please refer to Figure 34 , which shows the schematic diagram of the connection between the electrode elements in another embodiment of the electrode assembly in the present application. As shown, in this embodiment, when assembling multiple electrode elements into an electrode assembly, in order to facilitate the description of the connection structure between the multiple electrode elements, one electrode element is still defined as the intermediate electrode element 51, the electrode element located on the first side of the intermediate electrode element 51 is defined as the first electrode element 51', and the electrode element located on the second side of the intermediate electrode element 51 is defined as the second electrode element 51". In this embodiment, the distal end of the third proximal rod 5113 of the intermediate electrode element 51, the proximal end of the first side linkage 5121 of the intermediate electrode element 51, the distal end of the fourth proximal rod 5114' of the first electrode element 51', and the proximal end of the second side linkage 5122' of the first electrode element 51' are connected to each other; the proximal end of the third distal rod 5133 of the intermediate electrode element 51, the distal end of the first side linkage 5121 of the intermediate electrode element 51, the proximal end of the fourth distal rod 5134' of the first electrode element 51', and the distal end of the second side linkage 5122' of the first electrode element 51' are connected to each other; the distal end of the fourth proximal rod 5114 of the intermediate electrode element 51, the proximal end of the second side linkage 5122 of the intermediate electrode element 51, the distal end of the third proximal rod 5113" of the second electrode element 51", and the proximal end of the first side linkage 5121" of the second electrode element 51" are connected to each other; the proximal end of the fourth distal rod 5134 of the intermediate electrode element 51, the distal end of the second side linkage 5122 of the intermediate electrode element 51, the proximal end of the third distal rod 5133" of the second electrode element 51", and the distal end of the first side linkage 5121" of the second electrode element 51" are connected to each other.

[0230] As described above, when the plurality of electrode elements / ablation electrode elements 51 in the electrode assembly are arranged on the distal end of the ablation catheter 30, each two adjacent electrode elements are connected to each other, and therefore, a connecting ring 510 is arranged on each ablation electrode element 51 to connect the adjacent electrode elements. In order to ensure better connection of the two adjacent electrode elements at the connecting ring 510, in an embodiment, the proximal end portion and the distal end portion of the first side connecting rod 5121 have a bending structure, respectively. Please refer to Figure 35 , which shows an enlarged schematic view of the connection of the plurality of electrode elements in the electrode assembly in an embodiment of the present application. As shown in the figure, the proximal end portion and the distal end portion of the second side connecting rod 5122 have a bending structure 5123, respectively. When the connecting ring 510 on the first side connecting rod 5121 of one electrode element and the second side connecting rod 5122 of another electrode element are fixed by a fixing member such as an insulating pin, since the bending directions of the bending structures 5123 are opposite to each other, the connecting ring 510 is in an intersecting state. In another embodiment, the bending structure 5123 can also be formed on the distal end of the first proximal rod 5111 and the proximal end of the first distal rod 5131, and the bending structure 5123 can also be formed on the distal end of the fourth proximal rod 5114 and the proximal end of the fourth distal rod 5134.

[0231] When the inner tube 32 of the ablation catheter 30 moves axially in the proximal direction, it drives the forward branch structure 511 of each electrode element in the electrode assembly fixed on the distal end of the inner tube 32 to move in the proximal direction, and at the same time, the position of the reverse branch structure 513 of each electrode element in the electrode assembly fixed on the distal end of the outer tube 31 remains unchanged. As the inner tube 32 continues to move axially in the proximal direction, the space at both ends of the electrode assembly is compressed, and the at least one connecting rod structure 512 provides expansion support to the forward branch structure 511 and the reverse branch structure 513 during this process. Since each ablation electrode element 51 in the electrode assembly is a two-level branch structure, only one prismatic structure is provided on the proximal end and the distal end of each electrode element, which is beneficial to control the size of the expanded ball of the electrode assembly, and in particular, it can adapt to more patients, such as patients with different sizes of ostia of pulmonary veins in the heart.

[0232] In addition, the electrode assembly formed by the electrode elements composed of the forward branch structure 511, the reverse branch structure 513 and the connecting rod structure 512 can control the size of the ablation electrode by the length of the forward branch structure 511, the reverse branch structure 513 or the connecting rod structure 512.

[0233] Furthermore, the electrode assembly is easier to stretch or expand compared to a more complex mesh-type electrode assembly, and the prismatic structure retained in the secondary branch structure at both ends of the electrode sheet can provide support for the electrode element, so that the electrode ball composed of the electrode sheet can have better elasticity and can better expand in the human body.

[0234] In summary, the pulse ablation catheter provided in the present application effectively solves the phenomenon that the electrode ball expands too fast or too large to easily harm the human body tissue when the operator pulls the inner tube too hard or too fast by providing a buffer structure on the inner tube. In one embodiment provided in the present application, for example, the axis elasticity of the screw rod effectively buffers the speed of the diameter change of the expanded electrode ball when pulling the electrode assembly in the above-mentioned different embodiments, so that the diameter change is relatively gentle, and the operation difficulty of the operator is also reduced, which is beneficial to the operation.

[0235] The above embodiments only exemplarily illustrate the principles and effects of the present application, and are not used to limit the present application. Any person skilled in the art can modify or change the above embodiments without departing from the spirit and scope of the present application. Therefore, all equivalent modifications or changes completed by those skilled in the art without departing from the spirit and technical idea disclosed in the present application should be covered by the claims of the present application.

Claims

1. A pulsed ablation device, characterized by, The application relates to an ablation catheter, comprising: an outer tube extending from a proximal end to a distal end; an inner tube disposed in the outer tube and axially movable relative to the outer tube, wherein the inner tube is provided with a buffer structure which is an axially elastic structure or an axially elastic material integrally formed on the inner tube; an electrode assembly disposed between the outer tube and the inner tube, the electrode assembly comprising a plurality of electrode elements, each electrode element comprising a proximal end structure fixed to the distal end of the outer tube, a distal end structure fixed to the distal end of the inner tube, and a connecting rod structure connected between the proximal end structure and the distal end structure; 2. The pulsed ablation device of claim 1, wherein, wherein the buffer structure of the inner tube slows down the expansion speed of the electrode assembly when the electrode assembly is converted from a contracted state to an expanded state, and the initial speed of the proximal end portion of the inner tube is greater than that of the distal end portion of the inner tube when the inner tube moves towards the proximal end relative to the outer tube.

3. The pulsed ablation device of claim 1, wherein, The axially elastic structure is a spring structure.

4. The pulsed ablation device of claim 3, wherein, The buffer structure is integrally formed on the inner tube corresponding to the proximal end to the distal end of the electrode assembly, the middle section of the inner tube, or the section near the proximal end of the inner tube.

5. The pulsed ablation device of claim 4, wherein, The inner tube comprises a smooth section for being disposed in the outer tube and extending from the proximal end to the distal end of the outer tube to the distal end portion of the outer tube, a fixed section protruding from the distal end of the outer tube for fixing the distal end of the electrode assembly, and a buffer structure formed between the smooth section and the fixed section.

6. The pulsed ablation device of claim 1, wherein, The fixed section is provided with a limiting structure for limiting the displacement of the distal end of the electrode assembly relative to the inner tube.

7. The pulsed ablation device of claim 6, wherein, The buffer structure is a spring structure with a decreasing tube diameter from the proximal end to the distal end.

8. The pulsed ablation device of claim 1, wherein, The inner tube is a tube body with a decreasing tube diameter from the proximal end to the distal end.

9. The pulsed ablation device of claim 8, wherein, The electrode assembly comprises a plurality of electrode elements, each electrode element comprising a proximal end double rod structure fixed to the distal end of the outer tube, a distal end double rod structure fixed to the distal end of the inner tube, and a single rod structure connected between the proximal end double rod structure and the distal end double rod structure.

10. The pulsed ablation device of claim 8, wherein, The single rod structure of each electrode element in the plurality of electrode elements provides a contraction traction force when the electrode assembly is converted from an expanded state to a contracted state, and provides an expansion biasing force when the electrode assembly is converted from a contracted state to an expanded state.

11. The pulsed ablation device of claim 10, wherein, The proximal end double rod structure comprises a proximal end limiting rod, and a first proximal end rod and a second proximal end rod bifurcated from the proximal end limiting rod and symmetric to each other; the distal end double rod structure comprises a distal end limiting rod, and a first distal end rod and a second distal end rod bifurcated from the distal end limiting rod and symmetric to each other.

12. The pulsed ablation device of claim 11, wherein, The distal end of the first proximal end rod in one electrode element of the plurality of electrode elements is connected with the distal end of the second proximal end rod in another electrode element on the first side of the one electrode element; the distal end of the second proximal end rod in the one electrode element is connected with the distal end of the first proximal end rod in another electrode element on the second side of the one electrode element. The proximal end of the first distal end rod in one electrode element of the plurality of electrode elements is connected with the proximal end of the second distal end rod in another electrode element on the first side of the one electrode element; the proximal end of the second distal end rod in the one electrode element is connected with the proximal end of the first distal end rod in another electrode element on the second side of the one electrode element.

13. The pulsed ablation device of claim 12, wherein, The proximal end of the single rod structure in one of the plurality of electrode elements is coupled to the distal end of a second proximal rod in another electrode element on the first side of the electrode element; and the distal end of the second proximal rod is coupled to the proximal end of a first proximal rod in another electrode element on the second side of the electrode element.

14. The pulsed ablation device of claim 1, wherein, The electrode assembly comprises a plurality of electrode elements, each electrode element comprising a forward branch structure fixed to the distal end of the outer tube and a reverse branch structure fixed to the distal end of the inner tube, and at least one connecting rod structure coupled between the forward branch structure and the reverse branch structure; wherein the inner tube is axially moved relative to the outer tube to drive the electrode assembly to switch between the contracted state and the expanded state.

15. The pulsed ablation device of claim 14, wherein, The forward branch structure and the reverse branch structure of each electrode element in the plurality of electrode elements are moved relative to each other to switch the electrode element between the contracted state and the expanded state, and the at least one connecting rod structure provides a contraction traction force to the forward branch structure and the reverse branch structure in the contracted state or provides an expansion support force to the forward branch structure and the reverse branch structure in the expanded state.

16. The pulsed ablation device of claim 14, wherein, The forward branch structure of each electrode element comprises a proximal end limiting rod, and a first proximal rod and a second proximal rod symmetrically bifurcated from the proximal end limiting rod, a third proximal rod and a fifth proximal rod symmetrically bifurcated from the first proximal rod, and a fourth proximal rod and a sixth proximal rod symmetrically bifurcated from the second proximal rod; wherein the fifth proximal rod and the sixth proximal rod are coupled at a junction.

17. The pulsed ablation device of claim 16, wherein, The reverse branch structure of each electrode element comprises a distal end limiting rod, and a first distal rod and a second distal rod symmetrically bifurcated from the distal end limiting rod, a third distal rod and a fifth distal rod symmetrically bifurcated from the first distal rod, and a fourth distal rod and a sixth distal rod symmetrically bifurcated from the second distal rod; wherein the fifth distal rod and the sixth distal rod are coupled at a junction.

18. The pulsed ablation device of claim 17, wherein, The distal end of the third proximal rod in one of the plurality of electrode elements and / or the proximal end of the third proximal rod has a coupling ring for coupling to another ablation electrode element; and the distal end of the fourth proximal rod and / or the proximal end of the fourth proximal rod has a coupling ring for coupling to another ablation electrode element.

19. The pulsed ablation device of claim 1, wherein, A plurality of insulating members are further included for electrically insulating the coupling between two different electrode elements.

20. The pulsed ablation device of claim 19, wherein, The insulating members comprise insulating pins, insulating pins, or insulating spacers.

21. The pulsed ablation device of claim 1, wherein, The expansion degree of the electrode assembly in the expanded state determines the contact degree of each electrode element with the tissue.

22. The pulsed ablation device of claim 1, wherein, At least one measuring element is arranged on the proximal structure, the distal structure, or the connecting rod structure of at least one electrode element in the electrode assembly.

23. The pulsed ablation device of claim 1, wherein, At least one measuring element is arranged between at least two adjacent electrode elements in the electrode assembly.

24. The pulsed ablation device of claim 22 or 23, wherein, The measuring element comprises one of a temperature sensor, an impedance sensor, a positioning / position sensor, or an attitude sensor.

25. The pulsed ablation device of claim 1, wherein, A guide wire is further included, which can be arranged in the inner tube.

26. The pulsed ablation device of claim 1, wherein, The proximal end fixing ring is provided with a plurality of proximal end limiting portions corresponding to each electrode element on the ring body.

27. The pulsed ablation device of claim 26, wherein, The proximal end fixing ring is provided with a plurality of proximal end limiting portions corresponding to each electrode element on the ring body.

28. The pulsed ablation device of claim 1, wherein, The distal end fixing ring is provided with a plurality of distal end limiting portions corresponding to each electrode element on the ring body.

29. The pulsed ablation device of claim 1, wherein, The electrode assembly comprises six electrode elements arranged uniformly between the outer tube and the inner tube.

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