Pulse ablation device

Abstract

The present application discloses a pulse ablation device, comprising: an ablation catheter having an outer tube and an inner tube passing through the outer tube and capable of axially moving relative to the outer tube, and an electrode assembly arranged at the distal end of the ablation catheter; each electrode element in the electrode assembly comprises a proximal double-rod structure fixed to the distal end of the outer tube and a distal double-rod structure fixed to the distal end of the inner tube, and a single-rod structure connected between the proximal double-rod structure and the distal double-rod structure; the electrode element of the present application adopts a biased single-rod structure at the proximal and distal ends to provide an expansion support design. When the pulse ablation electrode is controlled by the inner tube, the force required for deformation will be greatly reduced, which is beneficial to the contraction or expansion of the pulse ablation electrode in the human body.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a pulse ablation device for a pulse ablation system. Background Art

[0002] In the field of electrophysiological therapy, using an ablation catheter to deliver energy and perform tissue ablation is a common method. After the distal end of the ablation catheter is inserted into the heart and reaches the corresponding treatment target, an energy platform connected to the proximal end of the ablation catheter transmits energy (such as radiofrequency, ultrasound, pulse energy, etc.) to the energy delivery electrode on the ablation catheter tip. Once the electrode contacts the tissue, it transfers energy to the tissue, ablating it.

[0003] Currently, commonly used ablation methods include radiofrequency, ultrasound, or cryoablation. While these ablation methods offer certain advantages, they also have limitations. For example, the ablation energy lacks selectivity in destroying tissue in the ablation area and relies on the force of the catheter, potentially causing damage to the adjacent esophagus, coronary arteries, and phrenic nerves. Therefore, the search for a safe and efficient ablation method that achieves durable pulmonary vein isolation without damaging adjacent tissues has become a recent research hotspot in the industry. In addition to using pressure-sensing radiofrequency ablation based on the ablation index (AI) or lesion index (LSI), a new high-power, short-duration (HPSD) ablation method, namely pulsed field ablation (PFA), has also demonstrated its effectiveness and safety in the past two years. Since the initial application of this novel non-thermal pulsed field energy system demonstrated promising clinical results, research on PFA products has been increasing.

[0004] Currently, common pulsed electric field ablation catheters use conventional ring electrodes. For example, electrode sheets are arranged at intervals on a ring carrier to approach the tissue to be ablated, such as the pulmonary vein. Although the structure of this type of ring electrode is simple, in actual ablation surgery, it is often difficult to adjust the expansion degree of its ring structure or it requires doctors to have a higher level of operation, thereby failing to achieve the ideal ablation effect. In addition, strip-shaped ball cage electrodes are set at the distal end of the ablation catheter to make up for the defects of the ring electrode. However, these strip-shaped ball cage electrodes are not connected to each other. Although they are easy to retract, adjacent electrodes often collide with each other during operation. Furthermore, the industry has also proposed a mesh-structured ball cage electrode. Although the mesh-structured ball cage electrode is stable, it is not easy to retract into the sheath of the conveyor when the ablation catheter is withdrawn after surgery, making the operation difficult and time-consuming. Summary of the Invention

[0005] In view of the shortcomings of the related technologies mentioned above, the purpose of this application is to provide a pulse ablation device to solve the technical problems in the prior art, such as the complex structure of the ball cage electrode and the unsmooth or unstable transition between the contraction and expansion states.

[0006] To achieve the above-mentioned purpose and other related purposes, the present application discloses a pulse ablation device, comprising: an ablation catheter, comprising an outer tube extending from the proximal end toward the distal end and an inner tube passing through the outer tube and capable of axially moving relative to the outer tube; an electrode assembly, comprising a plurality of electrode elements arranged between the outer tube and the inner tube, each electrode element comprising a proximal double-rod structure fixed to the distal end of the outer tube and a distal double-rod structure fixed to the distal end of the inner tube, and a single-rod structure connected between the proximal double-rod structure and the distal double-rod structure; wherein, when the inner tube moves axially relative to the outer tube, it drives the electrode assembly to switch between a contracted state and an expanded state.

[0007] In one embodiment of the present application, the single-rod structure of each electrode element in the multiple electrode elements provides a contraction traction force when the electrode assembly is transformed from an expanded state to a contracted state; and provides an expansion bias force when the electrode assembly is transformed from a contracted state to an expanded state.

[0008] In one embodiment of the present application, the expansion degree of the electrode assembly in the expanded state determines the contact or proximity degree between each electrode element and the tissue.

[0009] In one embodiment of the present application, at least one measuring element is provided on the proximal double-rod structure, the distal double-rod structure, or the single-rod structure of at least one electrode element in the electrode assembly.

[0010] In one embodiment of the present application, at least one measuring element is provided between at least two adjacent electrode elements in the electrode assembly.

[0011] In one embodiment of the present application, the measuring element includes one of a temperature sensor, an impedance sensor, a positioning / position sensor, or a posture sensor.

[0012] In one embodiment of the present application, a guide wire that can be passed through the inner tube is also included.

[0013] In one embodiment of the present application, it also includes a proximal fixing ring arranged in the tubular cavity at the distal end of the outer tube for fixing the proximal double-rod structure of the electrode assembly, and the ring body of the proximal fixing ring is evenly provided with multiple proximal limiting portions corresponding to each electrode element, and each proximal limiting portion has a proximal clamping groove for engaging the proximal double-rod structure.

[0014] In one embodiment of the present application, the ring body of the proximal fixing ring is wrapped with a coating layer for fixing the electrode assembly.

[0015] In one embodiment of the present application, it also includes a distal fixing ring arranged at the distal end of the inner tube for fixing the distal double-rod structure of the electrode assembly, and the ring body of the distal fixing ring is evenly provided with multiple proximal limiting portions corresponding to each electrode element, and each proximal limiting portion has a distal clamping groove for engaging the distal double-rod structure.

[0016] In one embodiment of the present application, the electrode assembly includes six electrode elements evenly arranged between the outer tube and the inner tube.

[0017] In one embodiment of the present application, the proximal double-rod structure of each electrode element includes a proximal limiting rod, and a first proximal rod and a second proximal rod that are forked from the proximal limiting rod and are symmetrical to each other; the distal double-rod structure of each electrode element includes a distal limiting rod, and a first distal rod and a second distal rod that are forked from the distal limiting rod and are symmetrical to each other.

[0018] In one embodiment of the present application, the distal end of the first proximal rod in one electrode element among the multiple electrode elements is connected 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 connected to the distal end of the first proximal rod in another electrode element on its second side.

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

[0020] In one embodiment of the present application, the proximal end of the single-rod structure in one of the multiple electrode elements is connected to the distal end of the second proximal rod in another electrode element on the first side of the electrode element; and its distal end is connected to the proximal end of the first proximal rod in another electrode element on the second side of the electrode element.

[0021] In one embodiment of the present application, a plurality of insulating members are further included for electrically insulating the connection between two different electrode elements.

[0022] In one embodiment of the present application, the insulating member includes an insulating nail, an insulating pin, or an insulating gasket.

[0023] To summarize, the pulse ablation device provided in the present application adopts an ablation electrode structure including a proximal double-rod structure, a distal double-rod structure, and a single-rod structure. A biased single-rod structure is used at the proximal and distal parts of the ablation electrode element to provide expansion support to form a ball cage electrode. Compared with the traditional mesh electrode ball cage with a complex structure, the electrode assembly of the present application has both the stability of the mesh ball cage type electrode and the advantage of the easy folding of the strip ball cage type. Therefore, 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 adjacent electrodes will not accidentally touch each other due to lack of constraints.

[0024] In addition, each electrode element in the pulse ablation device of the present application adopts a single-rod structure with a biased setting at the proximal and distal parts to provide an expansion support design, so that the pulse ablation electrode can achieve more flexible controllability. When the cardiac pulse ablation electrode is controlled by the inner tube, only the fold line part is deformed into an enlarged shape. Because each electrode element has only a single-rod structure with a fold line biased setting, the force required for deformation will be greatly reduced, which is conducive to the enlargement and reduction of the pulse ablation electrode in the human body. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] The specific features of the inventions of this application are set forth in the appended claims. The features and advantages of the inventions of this application can be better understood by referring to the exemplary embodiments described in detail below and the accompanying drawings. A brief description of the drawings is as follows:

[0026] Figure 1 Shown is a schematic diagram of a pulse ablation system in one embodiment of the present application.

[0027] Figure 2 Display as Figure 1 Enlarged schematic diagram of point A in the middle.

[0028] Figure 3 Shown is a schematic diagram of the electrode assembly in a contracted state in one embodiment of the present application.

[0029] Figure 4 Shown is a schematic diagram of the expanded state of the electrode assembly in one embodiment of the present application.

[0030] Figure 5 Shown is a schematic structural diagram of a fixing ring in one embodiment of the present application.

[0031] Figure 6 It is a cross-sectional schematic diagram of a distal fixing ring provided at the distal end of the inner tube in one embodiment of the present application.

[0032] Figure 7 Shown is a schematic diagram of the contracted state of an electrode assembly in one embodiment of the present application.

[0033] Figure 8 Shown is a schematic diagram of the expanded state of an electrode assembly in one embodiment of the present application.

[0034] Figure 9 Shown is a schematic diagram from a first perspective of the ablation electrode element structure of an electrode assembly in one embodiment of the present application.

[0035] Figure 10 A schematic diagram showing the ablation electrode element structure of an electrode assembly in one embodiment of the present application from a second perspective is shown.

[0036] Figure 11 Shown is a schematic diagram of the connection between electrode elements in one embodiment of the electrode assembly in this application.

[0037] Figure 12 Shown is a schematic diagram of the connection between electrode elements in another embodiment of the electrode assembly in this application. DETAILED DESCRIPTION

[0038] The following describes the implementation of the present application through specific embodiments. People familiar with this technology can easily understand other advantages and effects of the present application from the contents disclosed in this specification.

[0039] In the following description, reference is made to the accompanying drawings, which describe several embodiments of the present application. It should be understood that other embodiments may also be used, and that mechanical, structural, electrical, and operational changes may be made without departing from the spirit and scope of the present disclosure. The following detailed description should not be considered restrictive, and the scope of the embodiments of the present application is limited only by the claims of the published patents. The terms used herein are only for the purpose of describing specific embodiments and are not intended to limit the present application. Spatially related terms, such as "upper", "lower", "left", "right", "below", "below", "lower", "above", "upper", etc., may be used in the text to illustrate the relationship between one element or feature shown in the figure and another element or feature.

[0040] Although the terms first, second, etc. are used in some instances herein to describe various elements or parameters, these elements or parameters should not be limited by these terms. These terms are merely used to distinguish one element or parameter from another. For example, a first proximal rod can be referred to as a second proximal rod, and similarly, a second proximal rod can be referred to as a first proximal rod without departing from the scope of the various described embodiments. The first proximal rod and the second proximal rod both describe a rod located at the proximal end, but unless the context clearly indicates otherwise, they are not the same proximal rod. Similar situations also include a first distal rod and a second distal rod, etc.

[0041] Furthermore, as used herein, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context indicates otherwise. It should be further understood that the terms "comprise", "include" indicate the presence of the described features, steps, operations, elements, components, items, kinds, and / or groups, but do not exclude the presence, occurrence, or addition of one or more other features, steps, operations, elements, components, items, kinds, and / or groups. The terms "or" and "and / or" used herein are interpreted as inclusive, or mean any one or any combination. 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". Exceptions to this definition occur only when the combination of elements, functions, steps, or operations is inherently mutually exclusive in some way.

[0042] Cardiac pulsed electric field ablation is a new ablation method that uses pulsed electric fields as energy. Pulsed electric field ablation is achieved by designing an appropriate pulsed electric field and using multiple short-duration, high-voltage electric pulses to release ablation energy, making the ablation process non-thermal (no Joule heat generation), effectively inducing electroporation in myocardial cells, allowing extracellular ions to enter the cells, and causing myocardial cell fragmentation and death. The damage to tissues with a higher pulsed electric field threshold is also reversible, which can target damage to the myocardial conduction system and avoid complications caused by damage to other surrounding tissues. Compared with traditional radiofrequency and cryoenergy, pulsed electric field ablation is non-thermal ablation, so the pulsed electric field can selectively damage the myocardium while preserving blood vessels, nerves and tissues around the heart, such as the lungs, esophagus, and phrenic nerves.

[0043] In this application, when describing the pulse ablation device or any component or part of the handle, ablation catheter, or electrode assembly in the ablation device, the terms "proximal" and "distal" refer to the relative orientation, position, and direction of the components or actions relative to each other from the perspective of the physician using the product. Although "proximal" and "distal" are not restrictive, "proximal" generally refers to the end of the product that is closest to the physician during normal operation, while "distal" generally refers to the end that first enters the patient's body. In other words, "proximal" refers to the side that is closer to the user / operator, and correspondingly, "distal" refers to the side that is away from the user / operator; for example, when the ablation catheter delivers the electrode assembly to the target tissue in the human body, "distal" refers to the side that is closer to the target tissue; in this application, "proximal" and "distal" both indicate a direction and do not specifically refer to a component or a part of a device / element. For example, the "proximal end" of the ablation catheter refers to the end of the ablation catheter that is in the direction of the user / operator when in use, and the "distal end" of the ablation catheter refers to the end of the ablation catheter that is away from the direction of the user / operator when in use. It should be understood that in the description of this application, expressions such as "proximal side" or "distal side" may also be used to indicate a relative orientation, relative position, or direction.

[0044] In this application, the term "connection" or "connection" refers to a mechanical combination between two components or parts, which may be a combination that can be disassembled or assembled, or an inseparable one-piece combination; in this application, the term "integrated molding" refers to a structure that is formed in one step through a processing technology such as stamping, cutting, pouring, casting, injection molding, etc. The structure as a whole is an element and is inseparable.

[0045] In this application, the term "electrical connection" refers to an electrical connection used to achieve the transmission of electrical signals between two parts. For example, in some embodiments of this application, the electrode elements and electrode connectors in the electrode assembly are used to achieve the path of electrical signals through the electrode wire.

[0046] In this application, the term "axial movement" refers to movement along the axis direction. For example, the inner tube performs axial movement, which means that the inner tube as a whole can move along the axis direction. The movement can be from the distal direction to the proximal direction, or from the proximal direction to the distal direction.

[0047] In the present application, term " electroporation " is the phenomenon (that is, permeable molecules, cell membrane can be otherwise impermeable or semi-permeable to the molecules) that causes cell membrane to become " leaky ";It can also be referred to as electroosmosis, pulsed electric field treatment, non-thermal irreversible electroporation, irreversible electroporation, high-frequency irreversible electroporation, nanosecond electroporation or nano-electroporation electroporation and relate to applying high amplitude pulses to cause the physiological modification of the tissue cells applying energy. These pulses can preferably be short, for example, nanoseconds, microseconds or millisecond pulse widths, so as to allow application of high voltage, high current (for example, 20 amperes or more amperes), without the long duration current flow that may cause significant tissue heating and muscle stimulation. Pulsed electrical energy can induce the formation of microscopic defects, which cause the excessive permeability of cell membrane. Depending on the characteristics of the electric pulse, electroporated cells can survive after electroporation, known as " reversible electroporation " or die after electroporation, known as " irreversible electroporation ". Reversible electroporation can be used to deliver agents, including genetic material and other macromolecules or small molecules, into target cells for a variety of purposes, including altering the action potential of cardiomyocytes.

[0048] In this application, the term "electroporation" as used herein refers to applying an electric field to the cell membrane to change the permeability of the cell membrane to the extracellular environment. As used herein, the term "reversible electroporation" refers to applying an electric field to the cell membrane to temporarily change the permeability of the cell membrane to the extracellular environment. For example, cells undergoing reversible electroporation can observe temporary and / or intermittent formation of one or more pores in their cell membranes, which are closed when the electric field is removed. As used herein, the term "irreversible electroporation" refers to applying an electric field to the cell membrane to permanently change the permeability of the cell membrane to the extracellular environment. For example, cells undergoing irreversible electroporation can observe the formation of one or more pores in their cell membranes, which are still present when the electric field is removed.

[0049] The pulse ablation system disclosed in the present application includes a control device or delivery console and a pulse ablation device, wherein the control device or delivery console provides pulse ablation energy output and control, measurement and / or monitoring of the patient's physiological condition, and in response to the monitored / measured conditions, provides one or more predetermined or automatic programs for the emission of ablation or therapeutic energy. For example, the processing circuit system can be configured to execute a treatment program before or during the delivery of ablation or therapeutic energy. The control unit may include a dedicated user input device (e.g., a button, a switch, a GUI interface provided by a touch screen, etc.) that allows the operator to quickly and easily execute relevant programs before initiating the delivery of treatment or ablation energy, such as system parameters, the medical device used, the target tissue type, the non-target tissue type, the energy modality of the intended treatment, the user's assessment / judgment, etc.

[0050] The pulse ablation device can be directly coupled to a control device or a delivery console (such as a pulsed electric field generator that includes an energy control, delivery, and monitoring system). The control device or delivery console may also include a controller that communicates with the generator for operating and controlling various functions of the generator. Furthermore, the pulse ablation device may include one or more diagnostic or treatment areas for energy, treatment, and / or detection or diagnostic interaction between the pulse ablation device and the treatment site. The pulse ablation device can deliver pulsed electric field electroporation energy to a target tissue area near one or more treatment areas.

[0051] This application proposes a pulse ablation device, including: an ablation catheter and an electrode assembly. Figure 1 , which is a schematic diagram of a pulse ablation system in one embodiment of the present application. As shown in the figure, the pulse ablation system includes a delivery console 1 and a pulse ablation device 2; wherein, the pulse ablation device 2 includes an operating handle 20, an ablation catheter 30, and an electrode assembly 40.

[0052] In the present application, the ablation catheter 30 may be a catheter that can be delivered to a target tissue area via a sheath or an intravascular introducer. For example, in the use state of the ablation catheter 30, the guide sheath is pre-entered into the right ventricle via the superior vena cava and the right atrium. The distal end of the ablation catheter 30 extends from the distal end of the guide sheath and is inserted into a predetermined position of the ventricular wall to extend the electrode assembly 40. The electrode assembly 40 then expands during operation and releases pulse energy under the control of a control device / equipment to perform ablation. The elongated body of the ablation catheter 30 may define a proximal portion, a distal portion, and a longitudinal axis, and may further include one or more lumens disposed within the elongated body to provide mechanical communication, electrical communication, and / or fluid communication between the proximal portion and the elongated distal portion of the elongated body.

[0053] See also Figure 2 , displayed as Figure 1 The enlarged schematic diagram at A in the middle shows that the ablation catheter 30 includes an outer tube 31 and an inner tube 32 extending from the proximal end to the distal end, wherein the proximal end of the outer tube 31 is fixed to the operating handle, and the distal ends of the outer tube 31 and the inner tube 32 are fixed with an electrode assembly 40. 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 to the distal end portion of the outer tube 31. The inner tube 32 is inserted into the outer tube 31 and can move axially relative to the outer tube 31 (such as Figure 2 In the direction indicated by the arrow in the middle), the inner tube 32 can be operated to perform telescopic movement in the outer tube 31.

[0054] An electrode assembly 40 is fixed to the distal end of the inner tube 32. Specifically, the distal end of the inner tube 32 and the distal end of the outer tube 31 are jointly provided with a plurality of electrode elements. The proximal structure of each electrode element is fixed to the distal portion of the outer tube 31, and the distal structure of each electrode element is fixed to the distal portion of the inner tube 32, so that the plurality of electrode elements in the electrode assembly 40 are fixed between the distal end of the outer tube 31 and the distal end of the inner tube 32. In this way, 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 are switched between a contracted state and an expanded state.

[0055] See also Figure 3 , which is a schematic diagram of the electrode assembly in an embodiment of the present application in a contracted state. As shown in the figure, in the present application, the contracted state of the electrode assembly 40 refers to a state in which the proximal portion / proximal structure of each electrode element in the plurality of electrode elements in the electrode assembly 40 gradually moves away from its distal portion / distal structure, until the proximal portion / proximal structure and the distal portion / distal structure of each electrode element reach a maximum distance. At this time, the electrode assembly 40 as a whole presents a long strip shape, as shown in FIG. Figure 3 The status shown.

[0056] See also Figure 4 , which is a schematic diagram of the expanded state of the electrode assembly in one embodiment of the present application. As shown in the figure, in the present application, the expanded state of the electrode assembly 40 refers to the state in which the proximal portion / proximal structure of each electrode element in the plurality of electrode elements in the electrode assembly 40 gradually approaches its distal portion / distal structure, and the entire electrode assembly 40 expands in a spherical shape, as shown in FIG. Figure 4 The state shown. That is, the intermediate portion / connecting structure between the proximal portion / proximal structure and the distal portion / distal structure of each electrode element in the plurality of electrode elements tends to move away from the axis of the electrode assembly 40 until a preset minimum distance is reached between the proximal portion / proximal structure and the distal portion / distal structure of each electrode element.

[0057] In some embodiments, the outer tube 31 or inner tube 32 of the ablation catheter 30 may be made of materials such as polyether block amide, nylon, polyurethane, or silicone. In some embodiments, the ablation catheter 30 is equipped with an adjustable bend function, allowing it to reach any cardiac tissue site, thereby accommodating various lesion locations. The ablation catheter 30 comprises a braided tube made of polyurethane, PEBAX, and stainless steel wire, providing excellent torque response and support. Alternatively, in other embodiments, the ablation catheter 30 is made of a polymer material, more preferably a thermoplastic material, including one or more combinations of polymer materials such as PET (polyethylene terephthalate), PEBAX (polyether amide), PTFE (polytetrafluoroethylene), PI (polyimide), and PA (nylon). This provides the ablation catheter 30 with a certain degree of hardness and softness, preventing damage to the electrode wires or traction wires disposed therein while also effectively isolating the electrode wires or traction wires. More preferably, the ablation catheter 30 is made of PET material to obtain a sleeve with a certain hardness, thereby preventing the ablation catheter 30 from being deformed during the movement of the traction wire, thereby achieving a better use effect of the ablation catheter 30.

[0058] In the present application, the plurality of electrode elements in the electrode assembly 40 are fixed to the outer tube 31 or the inner tube 32 via a fixing ring.

[0059] See also Figure 5 , which is a schematic structural diagram of a fixing ring in one embodiment of the present application. It should be noted that the fixing ring fixed on the outer tube 31 or the inner tube 32 has the same structure. Due to different directions, the fixing ring fixed on the outer tube 31 is the proximal fixing ring 33 in the following embodiments, and the fixing ring fixed on the distal end of the inner tube is the distal fixing ring 34 in the following embodiments.

[0060] In one embodiment, the distal end of the outer tube 31 (e.g. Figure 4 A proximal fixing ring 33 is provided in the lumen of the proximal fixing ring 33 (shown at D1 in the figure). The proximal fixing ring 33 is used to fix the proximal structure of the electrode assembly. A plurality of proximal limiting portions are evenly provided on the ring body of the proximal fixing ring 33. Each of the plurality of proximal limiting portions corresponds to fixing an electrode element. In this embodiment, each proximal limiting portion has a proximal clamping groove 331 for engaging the proximal structure. The ring body of the proximal fixing ring 33 is wrapped with a coating layer (not shown) for fixing the electrode assembly. The coating layer wraps the proximal portion / proximal structure of each of the plurality of electrode elements in the electrode assembly in the proximal clamping groove 331 of the proximal fixing ring 33 to reinforce the fixation of the electrode assembly on the proximal fixing ring 33. The coating layer is made of an insulating material, such as insulating tape.

[0061] See also Figure 6 , which is a cross-sectional view of a distal fixing ring provided at the distal end of the inner tube in one embodiment of the present application. As shown in the figure, in this embodiment, the distal end of the inner tube 32 (such as Figure 4 A distal fixing ring 34 is disposed within the lumen of the distal end of the electrode assembly (shown at D2 in the figure). The distal fixing ring 34 is used to fix the distal structure of the electrode assembly. The ring body of the distal fixing ring 34 is evenly provided with multiple distal stoppers, each of which corresponds to fixing an electrode element. In this embodiment, each distal stopper has a distal retaining groove 341 for engaging the proximal structure. The peripheral sidewalls of the distal fixing ring 34 are provided with multiple distal retaining grooves 341 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 retained in a corresponding distal retaining groove 341.

[0062] In some embodiments, the inner tube 32 of the ablation catheter 30 may have a lumen that can receive a guidewire 28, so that the distal end of the catheter can be delivered to the treatment site over the wire. The lumen of the inner tube 32 can be configured to receive guidewires 28 of various sizes. In some embodiments, the guidewire 28 can be introduced into the inner tube 32 through a guidewire inlet of the handle.

[0063] In some embodiments, the ablation catheter 30 is provided with a channel (not shown) for the passage of the traction wire and the electrode wire. In one embodiment, for example, one or more rings or sleeves (not shown) are provided between the outer tube 31 and the inner tube 32, and the rings or sleeves are provided with a channel for the passage of the traction wire and the electrode wire. In another embodiment, the channel for the passage of the traction wire and the electrode wire can also be provided on the body of the outer tube 31, such as providing a wire or guidewire channel in the wall of the outer tube 31, so that the traction wire extends from the distal end of the ablation catheter 30 to the traction mechanism of the handle; and the electrode wire extends from the electrode assembly 40 fixed at the distal end of the ablation catheter 30 to the electrode connector on the handle and electrically connected thereto.

[0064] Present as Figure 1In the embodiment shown, the pulse ablation device 1 of the present application also includes an operating handle 20 coupled to the proximal portion of the ablation catheter 30 having a slender body. The operating handle 20 includes a connector (electrode connector in the present application) that can establish communication with a control device. The operating handle 20 may also include one or more actuating or control components to control the distal end of the ablation catheter to perform actions such as deflection, steering or axial movement. The operating handle 20 for the ablation catheter of the present application is used to connect the inner tube 32 and the outer tube 31 of the ablation catheter 30. In an embodiment, an electrode connector is also provided on the operating handle 20 for electrically connecting each electrode element in the electrode assembly 40 located at the distal end of the ablation catheter.

[0065] In the present application, the pulse ablation device further includes an electrode assembly consisting of one or more electrode elements (in some examples, the electrode elements may also be referred to as therapeutic elements), the one or more electrode elements being located at, coupled to, or on the distal end portion of the elongated body of the ablation catheter for energy, therapeutic, and / or investigative or testing interaction between the ablation device and the treatment site or region. As a non-limiting example, the electrode assembly can be converted between a contracted state and an expanded state, in which each electrode element has an arched or substantially circular configuration in the expanded state. For example, the electrode element can form a sphere or other expandable structure in the expanded state, such as a spherical, conical, rugby-shaped, hourglass-shaped, pear-shaped, onion-shaped, etc., and the cross-section of the sphere or other expandable structure can be located in a plane substantially orthogonal to the longitudinal axis of the elongated body.

[0066] In one embodiment, the degree of expansion of the electrode assembly in the expanded state determines the degree of contact between each electrode element and tissue. The spherical orientation of the expanded sphere can facilitate directing energy emitted by the multiple electrode elements into proximity or contact with target tissue at the treatment site. In one example, the target tissue is, for example, target tissue in the human heart, such as a pulmonary vein ostium.

[0067] In the present application, the plurality of electrode elements in the electrode assembly may also perform diagnostic functions, such as collecting intracardiac electrocardiograms / electrographs (EGM or EKG) / or monophasic action potentials (MAP) and performing selective pacing of intracardiac sites for diagnostic purposes. The measured signals may be fed back to a control device, and the plurality of electrode elements in the electrode assembly may also monitor proximity to target tissues and the quality of contact with such tissues using impedance-based measurements. The energy generator of the control device may include a high-speed relay to disconnect / reconnect specific electrodes from the generator during an energy delivery procedure. Immediately following pulsed energy delivery, the relay may reconnect one or more electrode elements for diagnostic purposes.

[0068] In this application, Figure 1 As shown, the electrode assembly 40 includes a plurality of electrode elements arranged between the outer tube 31 and the inner tube 32 of the ablation catheter 30, and each electrode element includes 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 end of the inner tube 32 and the distal end of the outer tube 31 are jointly provided with a plurality of electrode elements, the proximal structure of each electrode element is fixed to the distal part of the outer tube 31, and the distal structure of each electrode element is fixed to the distal part of the inner tube 32, so that the plurality of electrode elements in the electrode assembly 40 are fixed between the distal end of the outer tube 31 and the distal end of the inner tube 32, so that when the inner tube 32 and the outer tube 31 move relative to each other, the plurality of electrode elements in the electrode assembly are converted between a contracted state and an expanded state.

[0069] In an embodiment, the electrode assembly 40 includes a plurality of electrode elements. In some embodiments, a control device or a delivery console can be configured to electrically connect a set of electrode elements of the ablation device to a set of electrode channels. The control device or the 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, for example, the number of electrode elements of the electrode assembly is 6 for illustration.

[0070] In some embodiments, the material of the electrode elements in the electrode assembly 40 is, for example, Nitinol material. The electrode elements may also be coated with one or more of gold, tantalum, iridium oxide, or other materials.

[0071] In the following embodiments of this document, a single electrode element in the electrode assembly is referred to as an ablation electrode element. Figure 7 and Figure 8 , Figure 7 Shown is a schematic diagram of the contracted state of the electrode assembly in one embodiment of the present application, Figure 8 The figure shows the expanded state of the electrode assembly in one embodiment of the present application. As shown in the figure, the ablation electrode element 41 includes a proximal double-rod structure 411 , a distal double-rod structure 413 , and a single-rod structure 412 .

[0072] The proximal double-rod structure 411 is located at the proximal end D1, specifically, the proximal double-rod structure 411 is fixed at the distal end of the outer tube 31 of the ablation catheter 30, and accordingly, the distal double-rod structure 413 is located at the distal end D2, specifically, the distal double-rod structure 413 is fixed at the distal end of the inner tube 32 of the ablation catheter 30, and the single-rod structure 412 is connected between the proximal double-rod structure 411 and the distal double-rod structure 413. When the proximal double-rod structure 411 and the distal double-rod structure 413 move relative to each other, the ablation electrode element 41 is converted between a contracted state and an expanded state. The single-rod structure 412 provides a contraction traction force to the proximal double-rod structure 411 and the distal double-rod structure 413 in the contracted state or provides an expansion bias force to the proximal double-rod structure 411 and the distal double-rod structure 413 in the expanded state.

[0073] For example, when the inner tube 32 of the ablation catheter 30 moves axially toward the proximal direction, it drives the distal double-rod structure 413 of the ablation electrode element 41 fixed at the distal end of the inner tube 32 to move toward the proximal direction, while the position of the proximal double-rod structure 411 fixed at the distal end of the outer tube 31 remains unchanged. At this time, the ablation electrode element 41 gradually changes from a contracted state to an expanded state. During this process, the single-rod structure 412 provides an expansion bias force to the proximal double-rod structure 411 and the distal double-rod structure 413 in the expanded state until the ablation electrode element 41 is in a contracted state. The pole element 41 is expanded until the expected degree of expansion is reached; in the present application, the expansion bias force is a supporting force that provides a certain bias direction, that is, the supporting forces at both ends of the single-rod structure 412 are not parallel to the axial centerline direction of the inner tube 32 or the electrode assembly, and in the two-dimensional projection relationship, the bias direction intersects with the circumferential centerline direction at a certain angle, so that when the ablation electrode element 41 gradually changes from a contracted state to an expanded state, the single-rod structure 412 can support the ablation electrode element 41 into a shape with a raised middle part and a certain curvature. Correspondingly, when the inner tube 32 of the ablation catheter 30 moves axially toward the distal direction, it drives the distal double-rod structure 413 of the ablation electrode element 41 fixed at the distal end of the inner tube 32 to move toward the distal direction, while the position of the proximal double-rod structure 411 fixed at the distal end of the outer tube 31 remains unchanged. At this time, the ablation electrode element 41 gradually changes from an expanded state to a contracted state, and the single-rod structure 412 provides a contraction traction force to the proximal double-rod structure 411 and the distal double-rod structure 413 in the contracted state until the expected degree of contraction is reached.

[0074] In one embodiment, in order to better achieve the purpose of providing an expansion bias force to the proximal double-rod structure 411 and the distal double-rod structure 413 in the expanded state by the single-rod structure 412, the single-rod structure 412 is a connecting rod with an arc, that is, the single-rod structure 412 has a certain arc in a natural state without being subjected to force.

[0075] In one embodiment, the proximal dual-rod structure 411, the distal dual-rod structure 413, and the single-rod structure 412 are integrally formed. Specifically, the proximal dual-rod structure 411, the distal dual-rod structure 413, and the single-rod structure 412 are integrally formed from a single material via laser cutting or other fabrication processes. In a specific embodiment, the ablation electrode element 41 is made of, for example, nitinol. The electrode element may also be coated with one or more of gold, tantalum, iridium oxide, or other materials.

[0076] See also Figure 9 and Figure 10 , Figure 9 It is a schematic diagram showing the ablation electrode element structure of an electrode assembly in one embodiment of the present application from a first perspective. Figure 10 A second-perspective schematic diagram of the ablation electrode element structure of the electrode assembly in one embodiment of the present application is shown. As shown in the figure, in this embodiment, the proximal double-rod structure 411 includes a proximal limiting rod 4110, and a first proximal rod 4111 and a second proximal rod 4112 that are forked from the proximal limiting rod 4110 and are symmetrical to each other; accordingly, the distal double-rod structure 413 includes a distal limiting rod 4130, and a first distal rod 4131 and a second distal rod 4132 that are forked from the distal limiting rod 4130 and are symmetrical to each other. In this embodiment, the proximal limiting rod 4110 of the proximal double-rod structure 411 and the distal limiting rod 4130 of the distal double-rod structure 413 are located on the same axial line. It should be understood that the axial line mentioned here is only the axial line from the perspective of a single ablation electrode element 41. It can also be understood that the proximal limiting rod 4110 of the proximal double-rod structure 411 and the distal limiting rod 4130 of the distal double-rod structure 413 are located on the same straight line.

[0077] In one embodiment, the first proximal rod 4111 and the second proximal rod 4112 in the proximal double-rod structure 411 have the same rod diameter or width. In this 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; accordingly, the first distal rod 4131 and the second distal rod 4132 in the distal double-rod structure 413 have the same rod diameter or width. In this 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.

[0078] In one embodiment, the rod diameter or width of the first proximal rod 4111 or the second proximal rod 4112 in the proximal double-rod structure 411 is equal to the rod diameter or width of the first distal rod 4131 and the second distal rod 4132 in the distal double-rod structure 413. In this embodiment, the rod diameter or width of the first proximal rod 4111 or the second proximal rod 4112 in the proximal double-rod structure 411, and the rod diameter or width of the first distal rod 4131 and the second distal rod 4132 in the distal double-rod structure 413 are the same as the rod diameter or width of the single-rod structure 412.

[0079] In one embodiment, the proximal stopper 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 stopper 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.

[0080] In this embodiment, the proximal limiting rod 4110 is used to fix the proximal end of the ablation electrode element 41 to 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 to the distal end of the inner tube 32. As mentioned above, a proximal fixing ring 33 is provided in the tubular cavity at the distal end of the outer tube 31, and a plurality of proximal limiting portions are evenly provided on the ring body of the proximal fixing ring 33. Each proximal limiting portion has a proximal clamping groove 331 for engaging with the proximal double-rod structure 411. Correspondingly, corresponding to the structure of the proximal clamping groove 331, the proximal side of the proximal limiting rod 4110 of the proximal double-rod structure 411 has a proximal neck 41101, and the proximal neck 41101 can be engaged in the proximal clamping groove 331 to thereby fix the proximal end of the ablation electrode element 41 to the distal end of the outer tube 31. In this embodiment, the proximal locking groove 331 includes two wider grooves and a narrower groove located between the two wider grooves. The proximal neck 41101 of the proximal limiting rod 4110 is engaged with the narrower groove. Preferably, the ring body of the proximal fixing ring 33 is wrapped with a coating for fixing the electrode assembly. The coating wraps the proximal limiting rod 4110 of the proximal double-rod structure 411 of each of the multiple electrode elements in the electrode assembly within the proximal locking groove 331 of the proximal fixing ring 33, thereby strengthening the fixation of the electrode assembly to the proximal fixing ring 33. The coating is made of an insulating material, such as insulating tape or a coated insulating adhesive.

[0081] In this embodiment, the distal limiting rod 4130 is used to fix the distal end of the ablation electrode element 41 to the distal end of the inner tube 32. As mentioned above, the distal end of the inner tube 32 is sleeved with a distal fixing ring 34, and the ring body of the distal fixing ring 34 is evenly provided with a plurality of distal limiting parts, each distal limiting part has a distal clamping groove 341 for engaging with the distal double-rod structure 413. Accordingly, corresponding to the structure of the distal clamping groove 341, the distal side of the distal limiting rod 4130 of the distal double-rod structure 413 has a distal neck 41301, and the distal neck 41301 can be engaged in the distal clamping groove 341 to thereby fix the distal end of the ablation electrode element 41 to the distal end of the inner tube 32. In this embodiment, the distal locking groove 341 includes two wider grooves and a narrower groove located between the two wider grooves. The distal neck 41301 of the distal limiting rod 4130 is engaged with the narrower groove. Preferably, the ring body of the distal fixing ring 34 is wrapped with a coating for fixing the electrode assembly. The coating wraps the distal double-rod structure 413 of each of the multiple electrode elements in the electrode assembly within the distal locking groove 341 of the distal fixing ring 34 to strengthen the fixation of the electrode assembly to the distal fixing ring 34. The coating is made of an insulating material, such as insulating tape or a coated insulating adhesive.

[0082] In one embodiment, the two ends of the single-rod structure 412 are respectively connected to the proximal double-rod structure 411 and the distal double-rod structure 413. To ensure that the single-rod structure 412 provides an expansion bias force to the proximal double-rod structure 411 and the distal double-rod structure 413 in the expanded state, in this 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 accordingly, the distal end of the single-rod structure 412 is connected to the proximal end of the first distal rod 4131.

[0083] In one embodiment, the first proximal rod 4111 and the second proximal rod 4112 are symmetrical rod-shaped structures. Specifically, the first proximal rod 4111 and the second proximal rod 4112 are symmetrical curved rods, and the bending direction of the first proximal rod 4111 is a mirror image of the bending direction of the second proximal rod 4112. In this embodiment, after separating from the distal end of the proximal stop rod 4110, the first proximal rod 4111 and the second proximal rod 4112 bend and extend in opposite directions, forming a mirror image relationship of bending directions. In order to maintain a certain distance between the first proximal rod 4111 and the second proximal rod 4112 after separating from the distal end of the proximal stop rod 4110 to eliminate mutual influence when the first proximal rod 4111 and the second proximal rod 4112 are subjected to force, the first proximal rod 4111 and the second proximal rod 4112 form a U-shaped structure at the intersection of the proximal stop rod 4110.

[0084] In one embodiment, the first proximal rod 4111 and the second proximal rod 4112 form a certain angle therebetween after being separated from the distal end of the proximal limit rod 4110. Correspondingly, the first distal rod 4131 and the second distal rod 4132 also form a certain angle therebetween after being separated from the proximal end of the distal limit rod 4130. In this embodiment, the angle between the first proximal rod 4111 and the second proximal rod 4112, which are symmetrical to each other and are forked from the proximal limit rod 4110, is α, and the angle between the first distal rod 4131 and the second distal rod 4132, which are symmetrical to each other and are forked from the distal limit rod 4130, is β, wherein α≤β. In a preferred embodiment, the angle α is less than the angle β.

[0085] In one embodiment, the angle between the first proximal rod 4111 and the second proximal rod 4112, which are forked from the proximal limit rod 4110 and are symmetrical to each other, is α, wherein 10°≤α<120°; or 10°<α≤120°. The angle is α, wherein, in different embodiments, the angle α can be selected as follows: 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°, 61°, 62°, 63°, 64°, 65°, 66°, 67°, 68°, 69°, 70°, 71°, 72°, 73°, 74°, 75°, 76°, 77°, 78°, 79°, 80°, 81°, 82°, 83°, 84°, 85°, 86°, 87°, 88°, 89°, 90°, 91°, 92°, 93°, 94°, 95°, 96°, 97°, 98°, 99°, 100° 0°, 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°.

[0086] In some embodiments, the angle α between the first proximal rod 4111 and the second proximal rod 4112, which are symmetrical and bifurcated from the proximal stop rod 4110, is 15°≤α<45°; or 15°<α≤45°. In different embodiments, the angle α can be selected from: 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°.

[0087] In one embodiment, the first distal rod 4131 and the second distal rod 4132 are symmetrical straight rods. In this embodiment, the first distal rod 4131 and the second distal rod 4132 intersect at the distal stop rod 4130 to form a V-shaped structure. In another possible embodiment, the first distal rod 4131 and the second distal rod 4132 intersect at the distal stop rod 4130 to form a U-shaped structure.

[0088] In some embodiments, the angle between the first distal rod 4131 and the second distal rod 4132, which are forked from the distal limit rod 4130 and symmetrical to each other, is β, wherein 10°≤β<120°; or 10°<β≤120°. In different embodiments, the angle β can be selected as follows: 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°.

[0089] In some embodiments, the angle β between the first distal rod 4131 and the second distal rod 4132, which are symmetrical and bifurcated from the distal stop rod 4130, is 45°≤β<75°; or 45°<β≤75°. In different embodiments, the angle β can be selected from: 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°.

[0090] In another possible embodiment, the angle between the first proximal rod 4111 and the second proximal rod 4112 that are forked from the proximal limit rod 4110 and are symmetrical to each other is α, and the angle between the first distal rod 4131 and the second distal rod 4132 that are forked from the distal limit rod 4130 and are symmetrical to each other is β, wherein α>β.

[0091] In an embodiment, to control the expanded state of the multiple ablation electrode elements 41 in the electrode assembly, the spherical shape of the electrode sphere can be adjusted by configuring one or more portions of the proximal double-rod structure 411, the single-rod structure 412, or the distal double-rod structure 413 to present different spherical structures. In an embodiment, the spherical structure can be, for example, a structure in which the volume of the hemisphere at the proximal end is greater than the volume of the hemisphere at the distal end; or, alternatively, a structure in which the volume of the hemisphere at the proximal end is smaller than the volume of the hemisphere at the distal end; or, alternatively, a structure in which the volume of the hemisphere at the proximal end is equal to the volume of the hemisphere at the distal end.

[0092] In one embodiment, the first proximal rod 4111 and the second proximal rod 4112 have the same length, 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 first proximal rod 4111 and the second proximal rod 4112 have the same length, 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.

[0093] In one embodiment, the first distal rod 4131 and the second distal rod 4132 have the same length, 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 first distal rod 4131 and the second distal rod 4132 have the same length, 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.

[0094] As described above, the first proximal rod 4111 and the second proximal rod 4112 have the same length, and 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.

[0095] As described above, when the multiple electrode elements / ablation electrode elements 41 in the electrode assembly are disposed on the distal end of the ablation catheter 30, each two adjacent electrode elements are interconnected. Therefore, each ablation electrode element 41 is provided with a connecting ring 410 that connects to the adjacent electrode elements. In one embodiment, the distal ends of the first proximal rod 4111 and the second proximal rod 4112 of the proximal dual-rod structure 411 each have a connecting ring 410; correspondingly, the proximal ends of the first distal rod 4131 and the second distal rod 4132 of the distal dual-rod structure 413 each have a connecting ring 410. In this embodiment, the connecting ring 410 is a circular hole structure integrally formed on the proximal rod or distal rod, which is used to connect the proximal rod or distal rod of the other ablation electrode element 41 with a pin / pin made of insulating material.

[0096] In an 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 and the distal end of the first proximal rod 4111 share a connecting ring 410, and the distal end of the single-rod structure 412 and the proximal end of the second distal rod 4132 share a connecting ring 410.

[0097] In an 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 and the distal end of the second proximal rod 4112 share a connecting ring 410, and the distal end of the single-rod structure 412 and the proximal end of the first distal rod 4131 share a connecting ring 410.

[0098] In different embodiments, the opening amplitude formed by the first proximal rod 4111 and the second proximal rod 4112 in the proximal double-rod structure 411 and the opening amplitude formed by the first distal rod 4131 and the second distal rod 4132 in the distal double-rod structure 413 may be the same or different. For example, the distance between the connecting ring 410 at the distal end of the first proximal rod 4111 of the proximal double-rod structure 411 and the connecting ring 410 at the distal end of the second proximal rod 4112 is G1, and the distance between the connecting ring 410 at the proximal end of the first distal rod 4131 of the distal double-rod structure 413 and the connecting ring 410 at the proximal end of the second distal rod 4132 is G2. In one embodiment, G1>G2; or in another embodiment, G1=G2; in yet another embodiment, G1<G2.

[0099] In different embodiments, the spacing between the proximal double-rod structure 411 and the distal double-rod structure 413 can be configured with different distances. For example, the spacing between the proximal double-rod structure 411 and the distal double-rod structure 413 can be represented by the spacing between the connecting ring 410 at the distal end of the first proximal rod 4111 of the proximal double-rod structure 411 and the connecting ring 410 at the proximal end of the first distal rod 4131 of the distal double-rod structure 413, or by the spacing between the connecting ring 410 at the distal end of the second proximal rod 4112 of the proximal double-rod structure 411 and the connecting ring 410 at the proximal end of the second distal rod 4132 of the distal double-rod structure 413. For example, in the above-mentioned proximal double-rod structure In an embodiment in which the distance between the connecting ring 410 at the distal end of the first proximal rod 4111 of the double-rod structure 411 and the connecting ring 410 at the distal end of the second proximal rod 4112 is G1, and the distance between the connecting ring 410 at the proximal end of the first distal rod 4131 of the distal double-rod structure 413 and the connecting ring 410 at the proximal end of the second distal rod 4132 is G2, the distance between the connecting ring 410 at the distal end of the first proximal rod 4111 of the proximal double-rod structure 411 and the connecting ring 410 at the proximal end of the first distal rod 4131 of the distal double-rod structure 413 is H, in one embodiment, 0<H<G1; in another embodiment, 0<H<G2; in yet another embodiment, 0<H<G1+G2.

[0100] Present as Figure 7 and Figure 8 In the embodiment shown, the electrode assembly includes a plurality of electrode elements 41 arranged between the outer tube 31 and the inner tube 32 of the ablation catheter 30, each electrode element 41 includes a proximal double-rod structure 411 fixed to the distal end of the outer tube 31 and a distal double-rod structure 413 fixed to the distal end of the inner tube 32, and a single-rod structure 412 connected between the proximal double-rod structure 411 and the distal double-rod structure 413; wherein, when the inner tube 32 moves axially relative to the outer tube 31, it drives the electrode assembly to switch between a contracted state and an expanded state.

[0101] In the present application, the single-rod structure 412 of each electrode element in the plurality of electrode elements provides a contraction traction force when the electrode assembly transitions from an expanded state to a contracted state; and provides an expansion bias force when the electrode assembly transitions from a contracted state to an expanded state.

[0102] In an embodiment, the electrode assembly releases energy in an expanded state to treat the target tissue, and the degree of expansion of the electrode assembly in the expanded state determines the degree of contact or proximity between each electrode element and the tissue. In actual application, when the electrode tissue is delivered to the vicinity of the target tissue through the ablation catheter 30, the inner tube 32 is operated to move axially in the proximal direction so that the multiple electrode elements in the electrode assembly gradually expand from a contracted state to an expanded state. During this process, the spherical orientation of the expanded electrode ball can help apply the energy emitted by the multiple ablation electrode elements 41 to the target tissue at the treatment site, so that the energy is close to or in contact with the target tissue at the treatment site. Generally, when the electrode assembly expands into an electrode ball, the distal spherical surface formed by its distal double-rod structure 413 approaches or contacts the target tissue at the treatment site.

[0103] In some embodiments, the multiple ablation electrode elements 41 in the electrode assembly can also perform diagnostic functions, such as collecting intracardiac electrocardiograms / electrographs / or monophasic action potentials and performing selective pacing of intracardiac sites for diagnostic purposes. The measured signals can be fed back to the control device, and the multiple electrode elements in the electrode assembly can also monitor the proximity to the target tissue and the quality of contact with these tissues using impedance-based measurements. One or more measuring elements are also provided on the electrode assembly. In an embodiment, the measuring element includes one of a temperature sensor, an impedance sensor, a positioning / position sensor, or a posture sensor.

[0104] Based on different measurement purposes, the measuring element can be set at different positions in the electrode assembly. For example, in one embodiment, the measuring element is set on the proximal double-rod structure 411 of at least one electrode element in the electrode assembly; for example, in another embodiment, the measuring element is set on the distal double-rod structure 413 of at least one electrode element in the electrode assembly; for example, in yet another embodiment, the measuring element is set on the single-rod structure 412 of at least one electrode element in the electrode assembly.

[0105] In one embodiment, in order to increase the stability of the measuring element fixed in the electrode assembly or not affect the working state of the ablation electrode element 41, at least one measuring element is arranged between at least two adjacent electrode elements in the electrode assembly, that is, each measuring element can be arranged across the position between two adjacent electrode elements. For example, in actual structural design, the measuring element can be fixed by suture membranes and other components or structures, which will be described in detail later.

[0106] In the present application, the set of electrodes may 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 in the electrode assembly is 6. The electrode assembly includes 6 ablation electrode elements 41 consisting of a proximal double-rod structure 411, a distal double-rod structure 413, and a single-rod structure 412, wherein each ablation electrode element 41 is connected to two adjacent ablation electrode elements 41 on both sides.

[0107] In one embodiment, the distal end of the first proximal rod 4111 in one of the plurality of electrode elements is coupled 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 coupled 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 one of the plurality of electrode elements is coupled 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 coupled 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 one of the plurality of electrode elements is coupled to the distal end of the second proximal rod 4112 in another electrode element on its first side; and its distal end is coupled to the proximal end of the first proximal rod 4111 in another electrode element on its second side.

[0108] For example, in an embodiment where 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, see Figure 11, which is a schematic diagram of the connection between electrode elements in one embodiment of the electrode assembly in the present application. As shown in the figure, in order to conveniently illustrate the connection structure between multiple electrode elements, one electrode element is defined as an intermediate electrode element 41, the electrode element located on the first side of the intermediate electrode element 41 is defined as a first electrode element 41', and the electrode element located on the second side of the intermediate electrode element 41 is defined as a 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 of the intermediate electrode element 41 and the proximal end of the single rod structure 412 of the intermediate electrode element 41 share a connecting 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 second proximal rod 4112' 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 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 is connected to the proximal end of the single-rod structure 412" of the intermediate electrode element 41. The distal ends of the first distal rod 4131' of the second electrode element 41' share a connecting ring 410, and the proximal end of the first distal rod 4131' of the second electrode element 41' is also connected to the connecting 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'.

[0109] For another example, in the embodiment where the proximal end of the single-rod structure 412 in the electrode element 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 12, which is a schematic diagram showing the connection between electrode elements in another embodiment of the electrode assembly of the present application. As shown in the figure, in order to facilitate the description of the connection structure between multiple electrode elements, one electrode element is still defined as an intermediate electrode element 41, the electrode element located on the first side of the intermediate electrode element 41 is defined as a first electrode element 41', and the electrode element located on the second side of the intermediate electrode element 41 is still defined as a 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 first electrode element 41'. The distal end of the second proximal rod 4112' of the first electrode element 41' is connected. Since the distal end of the second proximal rod 4112' of the first electrode element 41' shares a connecting ring with 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'. The distal end of the second proximal rod 4112 of the intermediate electrode element 41 shares a connecting ring 410 with the proximal end of the single rod structure 412 of the intermediate electrode element 41. 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 of the intermediate electrode element 41 is connected to the proximal end of the second distal rod 4132' of the first electrode element 41'. The distal ends of the single-rod structure 412 of the intermediate electrode element 41 share a connecting ring 410, and 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 at the same time, 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".

[0110] In one embodiment, the electrode assembly further includes a plurality of insulating members (not shown) for electrically insulating the two different electrode elements at the junction between the two different electrode elements. In some embodiments, the insulating members include insulating nails, insulating pins, or insulating spacers. The insulating members are, for example, any of various biocompatible polymers, such as polyimide or polyetheretherketone (PEEK).

[0111] When the inner tube 32 of the ablation catheter 30 moves axially toward the proximal direction, it drives the distal double-rod structure 413 of each electrode element in the electrode assembly fixed at the distal end of the inner tube 32 to move toward the proximal direction. At this time, the position of the proximal double-rod structure 411 of each electrode element in the electrode assembly fixed at the distal end of the outer tube 31 remains unchanged. As the inner tube 32 continues to move axially toward the proximal direction, the space at both ends of the electrode assembly is compressed. At this time, the single-rod structure 412 of each electrode element provides an expansion bias force to the connected proximal double-rod structure 411 and the distal double-rod structure 413. In the structure of the electrode assembly provided, which includes a proximal double-rod structure 411, a distal double-rod structure 413, and a single-rod structure 412, a biased single-rod structure 412 is used at the proximal and distal parts to provide expansion support. Compared with the traditional mesh electrode ball cage with a complex structure, the electrode assembly of the present application has both the stability of the mesh ball cage type electrode and the advantage of the easy folding of the strip ball cage type. Therefore, the cardiac pulse ablation electrode can be more easily introduced into the human body, and the structure is stable after being opened in the human body, and there will be no situation where adjacent electrodes accidentally touch each other due to lack of constraints.

[0112] In addition, in the present application, a single-rod structure with a biased setting is used in the proximal and distal parts to provide an expansion support design, so that the pulse ablation electrode can achieve more flexible controllability. When the cardiac pulse ablation electrode is controlled by the inner tube, only the fold line part is deformed into an enlarged shape. Because each electrode element has only a single-rod structure with a fold line biased setting, the force required for deformation will be greatly reduced, which is conducive to the enlargement and reduction of the pulse ablation electrode in the human body.

[0113] The above embodiments are merely illustrative of the principles and effects of this application and are not intended to limit this application. Anyone skilled in the art may modify or alter the above embodiments without departing from the spirit and scope of this application. Therefore, all equivalent modifications or alterations made by one of ordinary skill in the art without departing from the spirit and technical concepts disclosed in this application shall be covered by the claims of this application.

Claims

1. A pulse ablation device, characterized in that: include: The ablation catheter comprises an outer tube extending from a proximal end toward a distal end and an inner tube passing through the outer tube and capable of axial movement relative to the outer tube; An electrode assembly, a plurality of electrode elements arranged between the outer tube and the inner tube, each electrode element comprising a proximal double-rod structure fixed to the distal end of the outer tube and a distal double-rod structure fixed to the distal end of the inner tube, and a single-rod structure connected between the proximal double-rod structure and the distal double-rod structure; wherein the inner tube drives the electrode assembly to switch between a contracted state and an expanded state when the inner tube moves axially relative to the outer tube, and the single-rod structure of each electrode element in the plurality of electrode elements provides a contraction traction force when the electrode assembly switches from the expanded state to the contracted state; and when the electrode assembly switches from the contracted state to the expanded state Provide expansion bias force during state conversion; the proximal double-rod structure of each electrode element includes a proximal limit rod, and a first proximal rod and a second proximal rod that are forked from the proximal limit rod and are symmetrical to each other; the distal double-rod structure of each electrode element includes a distal limit rod, and a first distal rod and a second distal rod that are forked from the distal limit rod and are symmetrical to each other, the proximal end of the single-rod structure in one electrode element among the multiple electrode elements is connected to the distal end of the second proximal rod in another electrode element on the first side of the electrode element; its distal end is connected to the proximal end of the first proximal rod in another electrode element on the second side of the electrode element.

2. The pulse ablation device according to claim 1, characterized in that The degree of expansion of the electrode assembly in the expanded state determines the degree of contact or proximity between each electrode element and tissue.

3. The pulse ablation device according to claim 1, characterized in that: At least one measuring element is provided on the proximal double-rod structure, the distal double-rod structure, or the single-rod structure of at least one electrode element in the electrode assembly.

4. The pulse ablation device according to claim 1, characterized in that: At least one measuring element is arranged between at least two adjacent electrode elements in the electrode assembly.

5. The pulse ablation device according to claim 3 or 4, characterized in that: The measuring element includes one of a temperature sensor, an impedance sensor, a positioning / position sensor, or a posture sensor.

6. The pulse ablation device according to claim 1, characterized in that: It also includes a guide wire that can be inserted into the inner tube.

7. The pulse ablation device according to claim 1, characterized in that: It also includes a proximal fixing ring arranged in the tubular cavity at the distal end of the outer tube for fixing the proximal double-rod structure of the electrode assembly, and a plurality of proximal limiting portions corresponding to each electrode element are evenly opened on the ring body of the proximal fixing ring, and each proximal limiting portion has a proximal clamping groove for clamping the proximal double-rod structure.

8. The pulse ablation device according to claim 7, characterized in that: The ring body of the proximal fixing ring is wrapped with a coating layer for fixing the electrode assembly.

9. The pulse ablation device according to claim 1, characterized in that: It also includes a distal fixing ring arranged at the distal end of the inner tube for fixing the distal double-rod structure of the electrode assembly, and a plurality of proximal limiting portions corresponding to each electrode element are evenly opened on the ring body of the distal fixing ring, and each proximal limiting portion has a distal clamping groove for engaging the distal double-rod structure.

10. The pulse ablation device according to claim 1, characterized in that: The electrode assembly includes six electrode elements evenly arranged between the outer tube and the inner tube.

11. The pulse ablation device according to claim 1, characterized in that: The distal end of the first proximal rod in one of the multiple electrode elements is connected 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 connected to the distal end of the first proximal rod in another electrode element on its second side.

12. The pulse ablation device according to claim 11, characterized in that: The proximal end of the first distal rod in one of the multiple electrode elements is connected 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 connected to the proximal end of the first distal rod in another electrode element on its second side.

13. The pulse ablation device according to claim 11, characterized in that: It also includes a plurality of insulating parts for electrically insulating the connection between two different electrode elements.

14. The pulse ablation device according to claim 13, characterized in that: The insulating member includes an insulating nail, an insulating pin, or an insulating spacer.

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