Pulse ablation device

Abstract

The application discloses a pulse ablation device, which comprises an ablation catheter, an outer tube, an inner tube arranged in the outer tube and capable of moving axially relative to the outer tube, an electrode assembly arranged between the outer tube and the inner tube of the ablation catheter, and an operating handle connected to the ablation catheter. The angle control assembly and the axial movement assembly are arranged in a single handle through a middle core rod by the unique configuration mode and mechanism design of the mechanical assembly, which not only optimizes the design of the operating handle of the traditional ablation pulse, but also provides smaller operation difficulty for the operator, especially the doctor in the operation, thereby facilitating the operation and the precision control.

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 ablation catheter tail (proximal end) to the energy delivery electrode on the ablation catheter head, and the electrode delivers energy to the tissue after being in close contact with the tissue, so as to ablate the tissue.

[0003] The current stage generally uses ablation methods including 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 applying pressure sensing and performing precise and safe radio frequency ablation according to the ablation index (AI) or the lesion index (LSI), the new HPSD ablation method in the past 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 PFA products have been increasing.

[0004] In the ablation operation of atrial fibrillation, it is necessary to adjust the bending angle or expansion degree of the ablation electrode located in the human tissue such as the heart through the handle. In the prior art, the mechanism for driving the ablation electrode bending and the mechanism for driving the ablation electrode expansion or contraction are usually configured on different operation handles. In the process of operation by the doctor, usually, multiple people need to cooperate to complete the control of the expected action of the ablation catheter, which is a great challenge to the operation efficiency and accuracy. SUMMARY

[0005] In view of the above-mentioned defects of the related art, the purpose of the present application is to provide a pulse ablation device to solve the problems of inconvenience and complexity caused by the need to equip different handles for different operations in the prior art.

[0006] To achieve the above object and other related objects, the pulse ablation device comprises 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; an electrode assembly comprising a plurality of electrode elements arranged between the outer tube and the inner tube of the ablation catheter, each electrode element comprising a proximal end structure fixed to the distal end of the outer tube and a distal end structure fixed to the distal end of the inner tube; and an operating handle for connecting the ablation catheter, comprising a handle body, an angle control assembly arranged on the handle body for controlling the angle turning of the distal end of the ablation catheter, and an axial movement assembly for driving the inner tube to move relative to the outer tube so as to switch the plurality of electrode elements between a contracted state and an expanded state.

[0007] In an embodiment of the present application, the operating handle comprises a handle body formed with an external holding portion, a first accommodating space formed in the interior of the handle body and located at a distal end portion, and a second accommodating space formed in the interior of the handle body and located at a proximal end portion.

[0008] In an embodiment of the present application, the angle control assembly comprises an angle driving mechanism arranged in the first accommodating space, and an angle knob arranged at the distal end of the handle body and fixedly connected with the angle driving mechanism.

[0009] In an embodiment of the present application, the axial movement assembly comprises an axial driving mechanism arranged in the second accommodating space and fixedly connected with the proximal end of the inner tube, and a knob partially located in the second accommodating space and used for operating the axial movement of the axial driving mechanism.

[0010] In an embodiment of the present application, a portion of the side wall of the handle body corresponding to the second accommodating space is provided with a guide wire hole for passing a guide wire so that the guide wire enters the handle body from the guide wire hole.

[0011] In an embodiment of the present application, the guide wire hole is located near the proximal end of the handle body.

[0012] In an embodiment of the present application, the handle body comprises a first shell and a second shell engaged with the first shell, wherein the first accommodating space formed in the first shell and the second shell is a closed space, and the second accommodating space formed in the first shell and the second shell is an open space to expose a portion of the knob arranged therein.

[0013] In an embodiment of the present application, the proximal end of the handle body is sleeved with a proximal end cover to fix the proximal ends of the first shell and the second shell.

[0014] In an embodiment of the present application, the knob is located at a position of 1 / 3 of the handle body near the proximal end.

[0015] In an embodiment of the present application, a third accommodation space is formed in the handle body and located at the proximal end of the handle body for accommodating an electrode connector, which is electrically connected to the electrode assembly through an electrode lead.

[0016] In an embodiment of the present application, a middle core rod is hollow for connecting the outer tube and the inner tube of the ablation catheter, and for arranging the angle driving mechanism in the first accommodation space and the axial movement mechanism in the second accommodation space.

[0017] In an embodiment of the present application, the proximal end of the outer tube is fixed in the middle core rod, and the proximal end of the inner tube is fixedly connected to the axial movement mechanism.

[0018] In an embodiment of the present application, a compartment for clamping the middle core rod is provided between the first accommodation space and the second accommodation space in the handle body, and a clamping structure is provided in the compartment to clamp the middle core rod in the handle body.

[0019] In an embodiment of the present application, the compartment is located at a position of 1 / 3 of the handle body near the distal end.

[0020] In an embodiment of the present application, the middle core rod comprises a hollow rod body and a clamping portion provided in the middle of the rod body to be clamped in the compartment to clamp the rod body in the handle body.

[0021] In an embodiment of the present application, the rod body comprises a first limiting portion provided at the distal end of the rod body, a second limiting portion provided between the first limiting portion and the clamping portion, and a third limiting portion provided between the clamping portion and the proximal end of the rod body.

[0022] In an embodiment of the present application, the first limiting portion and / or the second limiting portion are clamping grooves provided in the rod body for cooperating with a clamping ring or a clamping sheet, and the third limiting portion is a protrusion integrally formed on the rod body.

[0023] In an embodiment of the present application, a first wire groove for passing a traction line is provided on the rod body between the distal end of the rod body and the second limiting portion.

[0024] In an embodiment of the present application, the proximal end portion of the rod body has a second wire slot extending from the proximal end of the rod body towards the distal end and terminating between the third limiting portion and the clamping portion to form an opening for the electrode lead wire to pass through the portion between the third limiting portion and the clamping portion.

[0025] In an embodiment of the present application, the angle driving mechanism comprises: a first traction member slidably sleeved between the second limiting portion and the clamping portion of the middle core rod; a first screw portion provided with external threads and a traction portion integrally formed with the first screw portion; a first sleeve sleeved between the first limiting portion and the clamping portion of the middle core rod, the distal end of which is fixedly connected with the angle knob, and the inner wall of the barrel of the first sleeve is formed with internal threads corresponding to the external threads of the first screw portion, so that when the angle knob drives the first sleeve to rotate, the first traction member screwed therein is displaced between the second limiting portion and the clamping portion.

[0026] In an embodiment of the present application, the distal end of the middle core rod protrudes out of the distal end of the first sleeve and is located in the angle knob.

[0027] In an embodiment of the present application, a linear guide rail is arranged on the rod body between the second limiting portion and the clamping portion, and the inner wall of the first traction member has a guide groove corresponding to the linear guide rail.

[0028] In an embodiment of the present application, the first screw portion is provided with a first wire hole for the traction wire from the distal end of the outer tube and / or the inner tube to pass through.

[0029] In an embodiment of the present application, the traction portion is provided with a second wire hole to fix the traction wire from the distal end of the outer tube and / or the inner tube.

[0030] In an embodiment of the present application, the distal end of the first sleeve exposes the first accommodating space of the handle body to combine the angle knob.

[0031] In an embodiment of the present application, the distal end of the first accommodating space has a sleeve clamping groove, and the outer lateral wall of the first sleeve is provided with a clamping strip corresponding to the sleeve clamping groove to limit a portion of the first sleeve in the first accommodating space.

[0032] In an embodiment of the present application, the axial driving mechanism comprises: a second traction member, which is slidably arranged between the third limiting portion of the middle core rod and the proximal end of the rod body; a second screw portion provided with external threads and a fixed tube integrally formed with the second screw portion; and a second sleeve, which is sleeved between the third limiting portion of the middle core rod and the proximal end of the rod body, and the inner wall of the barrel of the second sleeve is formed with internal threads corresponding to the external threads of the second screw portion, so that when the angle knob drives the first sleeve to rotate, the second traction member screwed in the first sleeve is displaced between the third limiting portion and the proximal end of the rod body.

[0033] In an embodiment of the present application, the knob is integrally formed at the proximal end of the second sleeve to drive the second sleeve to rotate when being actuated.

[0034] In an embodiment of the present application, the segment of the middle core rod from the third limiting portion towards the proximal end is a two-symmetrical columnar structure, and a second wire slot is formed between the two-symmetrical columnar structure.

[0035] In an embodiment of the present application, the second traction member has two crescent-shaped holes for respectively penetrating the two-symmetrical columnar structures on the rod body.

[0036] In an embodiment of the present application, the proximal end of the inner tube is fixed on the fixed tube of the second traction member.

[0037] In an embodiment of the present application, the second screw portion of the second traction member is provided with a through hole for the electrode lead wire to pass through.

[0038] In summary, the pulse ablation device of the present application is configured on different operation handles relative to the mechanism for driving the bending of the ablation electrode and the mechanism for driving the expansion or contraction of the ablation electrode in the prior art. The present application realizes both the bending function of the ablation catheter and the control of the expansion and contraction of the electrode ball on a single handle body. The angle control assembly and the axial motion assembly are configured in a single handle through a unique configuration mode and mechanism design of the middle core rod, which not only optimizes the design of the traditional ablation pulse operation handle, but also provides smaller operation difficulty for the operator, especially the doctor in the operation, thereby facilitating the operation and precision control. BRIEF DESCRIPTION OF DRAWINGS

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

[0040] Figure 1 FIG. 1 shows a schematic diagram of the pulse ablation system in an embodiment of the present application.

[0041] Figure 2 is shown as Figure 1 is shown as an enlarged view of the middle A.

[0042] Figure 3 is shown as an electrode assembly in a contracted state in an embodiment of the present application.

[0043] Figure 4 is shown as an electrode assembly in an expanded state in an embodiment of the present application.

[0044] Figure 5 is shown as a structure of a fixing ring in an embodiment of the present application.

[0045] Figure 6 is shown as a cross-sectional view of a distal end fixing ring provided at a distal end of an inner tube in an embodiment of the present application.

[0046] Figure 7 is shown as a schematic view of an operation handle in an embodiment of the present application.

[0047] Figure 8 is shown as an exploded view of a first housing and a second housing of an operation handle in an embodiment of the present application.

[0048] Figure 9 is shown as a schematic view of an internal structure of an operation handle in an embodiment of the present application.

[0049] Figure 10 is shown as an exploded view of an operation handle in an embodiment of the present application.

[0050] Figure 11 is shown as an exploded view of an angle control assembly in an embodiment of the present application.

[0051] Figure 12 is shown as an exploded view of an axial driving mechanism in an embodiment of the present application.

[0052] Figure 13 is shown as a schematic view of an operation handle in an embodiment of the present application assembling an angle control assembly and an axial driving mechanism. DETAILED DESCRIPTION

[0053] The advantages and effects of the present application can be easily understood by those skilled in the art from the contents disclosed in the present specification.

[0054] In the following description, reference is made to the accompanying drawings which form a part hereof, and in which are shown several embodiments of the present application. 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 not to be taken in a limiting sense, and the scope of embodiments of the present application are defined only by the claims of the issued patent. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of this application. Spatially relative terms, such as "upper", "lower", "left", "right", "below", "below", "bottom", "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.

[0055] Although the terms first, second, etc. can be 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 element or parameter. For example, a first shell can be termed a second shell, and similarly, a second shell can be termed a first shell, without departing from the scope of the various described embodiments. Both the first shell and the second shell are shells of a handle.

[0056] Also, as used in the description herein, 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 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. Only when changes of the combinations of elements, functions, steps or operations are inherently mutually exclusive, does this definition exception apply.

[0057] 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.

[0058] 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, 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 specifically refer to a component or part of 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, direction.

[0059] 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. In the present application, the term "coupling" or "connection" can also be directly connected, or indirectly connected through an intermediate medium, and can be an internal connection of two elements or an interaction relationship between two elements.

[0060] 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 to realize the passage of electrical signals.

[0061] In the present application, the term "axial movement" refers to movement in the direction of the axis, 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 axis, which can be from the distal end to the proximal end or from the proximal end to the distal end.

[0062] The pulse ablation system disclosed in the present application comprises 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 physiological condition of the patient, and in response to the monitored / measured condition, provides one or more predetermined or automatic programs to emit ablation or treatment energy. For example, the processing circuitry can be configured to execute a treatment program before or during the delivery of ablation or treatment energy. The control unit can include a dedicated user input device (e.g., buttons, switches, 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, medical devices used, target tissue types, non-target tissue types, energy modalities of the intended treatment, user's assessment / judgment, etc.

[0063] The pulse ablation device can be directly coupled to the control device or delivery console (such as a pulse electric field generator including 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 pulse ablation device can 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 pulse electric field electroporation energy to a target tissue region near one or more treatment areas.

[0064] Please refer to Figure 1 , which shows a schematic diagram of the pulse ablation system in an embodiment of the present application, as shown in the figure, the pulse ablation system comprises a delivery console 1 and a pulse ablation device 2; wherein the pulse ablation device 2 comprises an operating handle 20, an ablation catheter 30, an electrode assembly 40, 50.

[0065] 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 guide, 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 assembly 40, 50 is extended, then the electrode assembly 40, 50 is expanded by operation, and the pulse energy is released under the control of the control device / equipment 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 the elongated body thereof to provide mechanical communication, electrical communication and / or fluid communication between the proximal end portion and the distal end portion of the elongated body.

[0066] Please refer to Figure 2 , shown as Figure 1 , 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 on the operating handle, and the distal end of the outer tube 31 and the inner tube 32 is fixed with the 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 Figure 2 ), that is, the inner tube 32 can be operated to make telescopic movement in the outer tube 31.

[0067] 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 and the distal end of the outer tube 31 are 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, 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, so that the inner tube 32 and the outer tube 31 move relative to each other to convert the plurality of electrode elements in the electrode assembly 40, 50 between the contracted state and the expanded state.

[0068] Please refer to Figure 3, which shows a schematic diagram of the electrode assembly in a contracted state 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 a state in which the proximal end portion / proximal end structure of each of 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 of the electrode elements reach a maximum distance, at which time the electrode assembly 40, 50 as a whole assumes an elongated shape, as shown in the figure. Figure 3

[0069] Referring to Figure 4 , which shows a schematic diagram of the electrode assembly in an expanded state 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 a state in which the proximal end portion / proximal end structure of each of the plurality of electrode elements in the electrode assembly 40, 50 gradually moves closer to the distal end portion / distal end structure thereof, and the entire electrode assembly 40, 50 assumes a spherical shape, as shown in the figure. That is, the intermediate portion / connection structure between the proximal end portion / proximal end structure and the distal end portion / distal end structure of each of the plurality of electrode elements tends to move away from the axial line of the electrode assembly 40, 50 until the proximal end portion / proximal end structure and the distal end portion / distal end structure of each of the electrode elements reach a preset minimum distance. Figure 4

[0070] In some embodiments, the outer tube 31 or the inner tube 32 of the ablation catheter 30 is made of a material such as polyether block amide, nylon, polyurethane, or silicone. In some embodiments, the ablation catheter 30 is provided with an adjustable bending function, so that the ablation catheter 30 can reach any tissue site in the heart, so as 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 other embodiments, the material of the ablation catheter 30 is a high polymer material, 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 a certain degree of 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 a certain degree of hardness, which avoids deformation of the ablation catheter 30 during the movement of the pull wire, so that the ablation catheter 30 has a better use effect.

[0071] ​​In some embodiments, the inner tube 32 of the ablation catheter 30 can have a lumen that can receive the guidewire 28 such that the distal end portion of the catheter can be delivered over the guidewire to the treatment site. 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.

[0072] In some embodiments, the ablation catheter 30 is provided with a passage for the pull wire and the electrode wire to pass through (not shown), in one embodiment, for example, one or more collars or sleeves (not shown) are provided between the outer tube 31 and the inner tube 32, the collars or sleeves are provided with a passage for the pull wire and the electrode wire to pass through, in another embodiment, the passage for the pull wire and the electrode wire to pass through can also be provided on the tube body of the outer tube 31, such as a wire or guidewire passage provided in the tube wall of the outer tube 31, so that the pull wire extends from the distal end of the ablation catheter 30 to the pull mechanism of the handle, and the electrode wire extends from the electrode assembly 40, 50 fixed at the distal end of the ablation catheter 30 to the electrode connector electrically connected to the handle.

[0073] In the present application, the pulsed ablation device further comprises an electrode assembly composed of one or more electrode elements (in some examples, the electrode elements can also be referred to as treatment elements), which are 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 transitioned 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 inflated body structure, such as a spherical, conical, football, hourglass, pear, onion, etc., in the expanded state, a cross-section of which can lie in a plane substantially orthogonal to the longitudinal axis of the elongated body.

[0074] 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 inflated sphere can facilitate the application of energy emitted by the plurality of electrode elements to target tissue in proximity to or contact with the tissue to be treated. In one example, the target tissue is, for example, target tissue in a human heart, such as a pulmonary vein ostium.

[0075] In this application, multiple electrode elements in the electrode assembly can also perform diagnostic functions, such as collecting intracardiac electrograms / electrocardiograms (EGM or EKG) / or monophasic action potentials (MAP) and performing selective pacing of intracardiac positions for diagnostic purposes. The measured signals can be fed back to a control device, and the multiple electrode elements in the electrode assembly can also use impedance-based measurements to monitor the proximity to target tissues and the quality of contact with these tissues. The energy generator of the control device may include a high-speed relay to disconnect / reconnect specific electrodes from the generator during energy delivery procedures. Immediately following pulsed energy delivery, the relay can reconnect one or more electrode elements for diagnostic purposes.

[0076] In this application, as shown Figure 1 As 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 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 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. This allows the plurality of electrode elements in the electrode assembly 40, 50 to be 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 switch between a contracted state and an expanded state.

[0077] In embodiments, the electrode assemblies 40, 50 include a plurality of electrode elements. In some embodiments, a control device or delivery console may be configured to electrically connect a set of electrode elements of the ablation device to a set of electrode channels. The control device or delivery console may 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, may be connected to the delivery console. The set of electrodes may contain 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 in the electrode assembly is described as 6.

[0078] In some embodiments, the electrode elements in the electrode assemblies 40, 50 are made of materials such as nitinol, and the electrode elements may also be coated with one or more of gold, tantalum, iridium oxide or other materials.

[0079] 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.

[0080] Please refer to Figure 5 , which shows the structure 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 similar in structure. Due to different directions, the fixing ring fixed on the outer tube 31 is the proximal end fixing ring 33 in the following embodiments, and the fixing ring fixed on the distal end of the inner tube is the distal end fixing ring 34 in the following embodiments.

[0081] In an embodiment, the lumen of the distal end of the outer tube 31 (as shown at D1 in Figure 4 ) is provided with a proximal end fixing ring 33, which is used to fix the proximal end structure of the electrode assembly. The ring body of the proximal end fixing ring 33 is uniformly provided with a plurality of proximal end limiting portions, and each proximal end limiting portion corresponds to fix an electrode element. In the present embodiment, each proximal end limiting portion has a proximal end clamping groove 331 for clamping the proximal end structure. The ring body of the proximal end fixing ring 33 is wrapped with a cladding layer (not shown) for fixing the electrode assembly. The cladding layer wraps the proximal end portion / proximal end structure of each electrode element in the plurality of electrode elements of the electrode assembly in the proximal end clamping groove 331 of the proximal end fixing ring 33, so as 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, etc.

[0082] Please refer to Figure 6 , which shows the cross-sectional view of the distal end fixing ring provided on the distal end of the inner tube in an embodiment of the present application. As shown in the figure, in the present embodiment, the lumen of the distal end of the inner tube 32 (as shown at D2 in Figure 4 ) is provided with a distal end fixing ring 34, which is used to fix the distal end structure of the electrode assembly. The ring body of the distal end fixing ring 34 is uniformly provided with a plurality of distal end limiting portions, and each distal end limiting portion corresponds to fix an electrode element. In the present embodiment, each distal end limiting portion has a distal end clamping groove 341 for clamping the proximal end structure. The four peripheral side walls of the distal end fixing ring 34 are provided with a plurality of distal end clamping grooves 341 for clamping the distal end structure of the electrode assembly. The distal end portion / distal end structure of each electrode element in the plurality of electrode elements of the electrode assembly is clamped in the corresponding distal end clamping groove 341.

[0083] In the present application, please refer to Figure 1 Figure 7 , Figure 7 ​The diagram shows an operating handle in one embodiment of this application. As shown, the pulse ablation device includes an operating handle 20 coupled to the proximal portion of an ablation catheter 30, which is an elongated body. The operating handle 20 includes a connector (electrode connector in this application) for establishing communication with a control device 1. The operating handle 20 may also include one or more actuating or controlling components 24 and 25 to control the distal end of the ablation catheter 30 to perform actions such as deflection, turning, or axial movement. The operating handle 20 for the ablation catheter 30 in this application is used to connect the inner tube 32 and the outer tube 31 of the ablation catheter 30. In this embodiment, the operating handle 20 is also provided with an electrode connector (…). Figure 7 (Not shown in the image), used for electrically connecting each electrode element in the electrode assemblies 40, 50 located at the distal end of the ablation catheter 30. In this embodiment, the operating handle 20 includes a handle body 21, an angle control assembly 24, and an axial movement assembly 25.

[0084] In one embodiment, the operating handle 20 includes a handle body 21 having an external grip portion, the external grip portion being an ergonomic single-handed grip structure conforming to the operator's ergonomics. The handle body 21 is defined as a distal portion and a proximal portion according to the direction from the distal end D2 toward the proximal end D1. For example, the distal portion refers to the portion approximately between 1 / 2 of the entire handle body 21 and the distal end, and the proximal portion refers to the portion approximately between 1 / 2 of the entire handle body 21 and the proximal end.

[0085] Please see Figure 8 and Figure 9 , Figure 8 The diagram shown is an exploded view of the first and second housings of the operating handle in one embodiment of this application. Figure 9 The figure shows a schematic diagram of the internal structure of the operating handle in one embodiment of this application. As shown, in this embodiment, the handle body 21 has a first accommodating space 213 and a second accommodating space 214, wherein the first accommodating space 213 is located at the distal end of the handle body 21; and the second accommodating space 214 is located at the proximal end of the handle body 21. In this embodiment, the first accommodating space 213 and the second accommodating space 214 formed in the handle body 21 are realized by assembling a first housing 211 and a second housing 212.

[0086] The angle control assembly 24 is arranged on the handle body 21 for controlling the angle steering of the distal end of the ablation catheter 30. In an embodiment, the angle control assembly 24 comprises an angle driving mechanism 240 and an angle knob 243. The angle driving mechanism 240 is arranged in the first accommodating space 213, and the angle knob 243 is arranged at the distal end of the handle body 21 and fixedly connected to the angle driving mechanism 240. When the angle knob 243 is operated to rotate, the corresponding components in the angle driving mechanism 240 can be driven to rotate.

[0087] In the present application, the angle control assembly 24 is used to drive the distal end of the ablation catheter 30 to bend / steer, so that the electrode assembly at the distal end of the ablation catheter 30 can more accurately act on the target tissue to achieve the desired treatment effect.

[0088] The axial motion assembly 25 is used to drive the inner tube 32 to move relative to the outer tube 31 to switch the plurality of electrode elements between the contracted state and the expanded state. In an embodiment, the angle control assembly 24 comprises an axial driving mechanism 250 and a dial knob 253. The axial driving mechanism 250 is arranged in the second accommodating space 214 and fixedly connected to the proximal end of the inner tube 32. The dial knob 253 is partially arranged in the second accommodating space 214 for operating the axial driving mechanism 250 to move axially. When the dial knob 253 is operated, the corresponding components of the axial driving mechanism 250 in the second accommodating space 214 can be driven to move axially, thereby pulling or pushing the inner tube 32 to move axially relative to the outer tube 31, to realize the operation of contracting and expanding the plurality of electrode elements arranged at the distal end of the ablation catheter 30.

[0089] In an embodiment, a portion of the side wall of the handle body 21 corresponding to the second accommodating space 214 is provided with a guide wire hole 210 for passing a guide wire, so that the guide wire 28 can enter the inner tube 32 connected to the handle body 21 from the guide wire hole 210. In this embodiment, the guide wire hole 210 is located near the proximal end of the handle body 21. Specifically, the guide wire hole 210 is formed via a channel obliquely inserted into the side wall of the handle body 21. The channel of the guide wire hole 210 forms an angle of about 10°-60° with the axis of the handle body 21, so that the guide wire 28 can be inserted into the delivery tube inside the handle body 21 from the proximal end of the handle body 21 through the guide wire hole 210, and then reach the desired tissue site through the lumen of the delivery tube. In an embodiment, the angle between the channel of the guide wire hole 210 and the axis of the handle body 21 can be 10°, 15°, 20°, 25°, 30°, 35°, 40°, 45°, 50°, 55°, or 60°.

[0090] In this embodiment, the handle body 21 includes a first housing 211 and a second housing 212. The first housing 211 and the second housing 212 are connected and fixed by a snap-fit ​​structure. In this embodiment, the first housing 211 is provided with a plurality of hooks (not shown), and the second housing 212 is provided with a plurality of holes or slots 2120 corresponding to each hook. When assembling the first housing 211 and the second housing 212, the hooks on the first housing 211 are snapped into the holes or slots 2120 on the second housing 212 to achieve the purpose of assembling the two together.

[0091] In this embodiment, the first accommodating space 213 and the second accommodating space 214 formed within the handle body 21 are realized through the assembly of the first housing 211 and the second housing 212. The first accommodating space 213 formed within the first housing 211 and the second housing 212 is a closed space, meaning that when the first housing 211 and the second housing 212 are assembled together, the components disposed within the first accommodating space 213 are not visible. The second accommodating space 214 formed within the first housing 211 and the second housing 212 is an open space (appearing as...). Figure 9 The portion indicated by 215 exposes a portion of the dial 253 disposed therein. That is, when the first housing 211 and the second housing 212 are assembled together, a portion of the dial 253 disposed in the second receiving space 214 is exposed to the handle body 21. Specifically, in this embodiment, for ease of operation, half of the dial 253 protrudes from the second receiving space 214 or the handle body 21 so that it can be operated by tossing.

[0092] In this embodiment, to reinforce the combination of the first housing 211 and the second housing 212, a proximal end cap 22 is fitted onto the proximal end of the handle body 21 to secure the proximal ends of the first housing 211 and the second housing 212. In this embodiment, the proximal end cap 22 is screwed onto the proximal ends of the first housing 211 and the second housing 212 by means of internal threads on the proximal end cap 22 and external threads on the proximal end of the handle body 21; or it is secured to the proximal ends of the first housing 211 and the second housing 212 by means of snap-fit ​​or screw fastening. In this embodiment, the proximal end cap 22 has a through hole 220 to allow a cable plug from the ablation control device to be inserted into an electrode connector 23 installed inside the handle body 21.

[0093] In an embodiment, a third accommodating space 215 is formed in the handle body 21, which is located at the proximal end of the handle body 21 (the first shell 211 and the second shell 212) and is used to accommodate an electrode connector 23. In the embodiment, the electrode connector 23 is fixed in the third accommodating space 215, the distal end of which is an output end, and the proximal end is an input end. The output end of the electrode connector 23 is electrically connected to the electrode assembly through electrode wires. The input end of the electrode connector 23 is a plug structure or an interface, so that the cable plug from the ablation control device is inserted into the electrode connector 23 installed in the handle body 21.

[0094] In some embodiments, 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; accordingly, the electrode connector 23 connected to the set of electrodes through electrode wires has terminals corresponding to the distal and proximal ends of each electrode. For example, in an embodiment of the present application, the number of electrode elements in the electrode assembly is 10, and the number of terminals on the electrode connector 23 is 10. For another example, the number of electrode elements in the electrode assembly is 6, and the number of terminals on the electrode connector 23 is 10. In a specific implementation, the terminals in the electrode connector 23 are pins corresponding to the jacks.

[0095] In an embodiment as shown in FIG. 1, Figure 9 In an embodiment, a middle core rod 26 is arranged in the handle body 21, which is used to connect the outer tube 31 and the inner tube 32 of the ablation catheter 30. The middle core rod 26 is also used to arrange the angle driving mechanism 240 in the first accommodating space 213 and the axial movement mechanism 25 in the second accommodating space 214. The outer tube 31 and the inner tube 32 of the ablation catheter 30 are fixed on the middle core rod 26.

[0096] In an embodiment, the proximal end of the outer tube 31 is fixed on the distal end portion of the middle core rod 26, that is, the proximal end of the outer tube 31 is fixedly connected to the distal end of the middle core rod 26. In a specific implementation, the outer tube 31 can be fixed on the distal end of the middle core rod 26 by screw locking, clamping or heat staking, etc.

[0097] In another embodiment, the proximal end of the outer tube 31 is fixed to the middle portion of the central core rod 26. In this embodiment, the outer tube 31 is inserted into the central core rod 26 a certain distance to the middle portion of the central core rod 26 and then fixedly connected to the central core rod 26. A first groove 265 is provided on the rod body 260 of the central core rod 26 so that the traction wire 27 for bending from the distal end of the ablation catheter 30 passes through the first groove 265 to connect to the traction block. In this embodiment, the traction block is referred to as the first traction member 241, which will be described in detail later. The first groove 265 is provided on the rod body 260 of the central core rod 26 and extends from the distal end to the proximal end by a certain distance. The position where the proximal end of the outer tube 31 is fixed to the middle portion of the central core rod 26 is a certain distance away from the proximal end of the first groove 265 so as to leave a gap for the traction wire to pass through. In a specific implementation, the outer tube 31 can be fixed to the middle part of the central core rod 26 (near the near end of the wire groove) by means of screw fastening, snap-fitting, or heat fusion.

[0098] In one embodiment, the proximal end of the inner tube 32 is fixedly connected to the axial motion mechanism 25. Specifically, the axial motion mechanism 25 includes a traction block for pulling the inner tube 32 in axial movement. In this embodiment, the traction block is referred to as the second traction member, which will be described in detail later. The traction block is provided with a fixing hole for fixing the proximal end of the inner tube 32, so that the inner tube 32 is fixed to the traction block by means of screw fastening, snap-fitting, or heat fusion.

[0099] Presented as Figure 9 In the illustrated embodiment, a compartment 216 for engaging the central core rod 26 is provided between the first accommodating space 213 and the second accommodating space 214 in the handle body 21. The compartment 216 contains an engaging structure (not shown) to secure the central core rod 26 within the handle body 21. In this embodiment, the engaging structure is a locking block, used to engage with a slot formed on the central core rod 26 to prevent the central core rod 26 from rotating or moving axially within the handle body 21. The compartment 216 between the first accommodating space 213 and the second accommodating space 214 is located approximately one-third of the way down the handle body 21 from its distal end; that is, from the perspective of the handle body 21 as a whole, the compartment 216 is closer to the distal end of the handle body 21.

[0100] Accordingly, in the present embodiment, the middle core rod 26 comprises a hollow rod body 260 and a clamping portion 261 arranged at the middle portion of the rod body 260 to be clamped in the compartment 216 so as to clamp the rod body 260 in the handle body 21. The clamping portion 261 is a circular plate integrally formed on the rod body 260 of the middle core rod 26, and the clamping portion 261 is provided with a clamping groove or notch corresponding to the clamping block in the compartment 216. When the clamping portion 261 of the middle core rod 26 is combined with the clamping block of the compartment 216, the side walls on both sides of the compartment 216 limit the displacement of the middle core rod 26 in the distal and proximal directions, and the clamping block of the compartment 216 limits the rotation of the middle core rod 26 in the handle body 21.

[0101] Referring to Figure 10 , which shows an exploded view of an embodiment of the operating handle of the present application. As shown in the figure, in the present embodiment, the hollow rod body 260 of the middle core rod 26 comprises a plurality of limiting portions, specifically, a first limiting portion 262, a second limiting portion 263, and a third limiting portion 264. The first limiting portion 262 is arranged at the distal end portion of the rod body 260, the second limiting portion 263 is arranged between the first limiting portion 262 and the clamping portion 261, and the third limiting portion 264 is arranged between the clamping portion 261 and the proximal end of the rod body 260. In the present embodiment, the first limiting portion 262 and / or the second limiting portion 263 are clamping grooves provided on the rod body 260 for cooperating with a clamping ring or a clamping sheet, and the third limiting portion 264 is a protrusion integrally formed on the rod body 260.

[0102] Referring to Figure 11 , which shows an exploded view of an embodiment of the angle control assembly of the present application. As shown in the figure, in the present embodiment, a clamping groove is provided on the cylindrical rod body 260 of the middle core rod 26 to form the above-mentioned first limiting portion 262 or second limiting portion 263. The clamping groove can be matched with a clamping ring 29 or a clamping sheet to limit the components arranged on the rod body 260. In the implementation, the components of the angle driving mechanism 240 are considered to be installed, and the clamping ring is a non-closed clamping ring which can be installed on the clamping groove from the radial direction or taken off from the clamping groove from the radial direction.

[0103] In Figure 10 the example, the third limiting portion 264 is a protrusion or a protruding block integrally formed on the rod body 260 to limit the activity range of the corresponding components in the axial driving mechanism 250. Of course, as for the arrangement of the first limiting portion 262 and the second limiting portion 263, the third limiting portion 264 can also adopt the implementation manner of the first limiting portion 262 and the second limiting portion 263.

[0104] InFigure 11 In the example shown in FIG. 6, the rod body 260 of the middle core rod 26 has a wire slot formed on the distal end portion thereof. In the example shown in FIG. 6, a first wire slot 265 is formed on the rod body 260 between the distal end of the rod body 260 and the second limiting portion 263, for the bending wire 27 to pass through. The bending wire 27 from the distal end of the outer tube 31 passes through the first wire slot 265 to be connected to the traction block (first traction member 251). Due to the presence of the first wire slot 265, the distal end of the rod body 260 has a C-shaped cross section.

[0105] In an embodiment, the distal end of the middle core rod 26 protrudes out of the distal end of the first sleeve 242 and is located in the angle knob 243. In the example shown in FIG. 6, the proximal end of the outer tube 31 is fixed to the distal end portion of the middle core rod 26, i.e., the proximal end of the outer tube 31 is combined with the portion of the middle core rod 26 that protrudes out of the first sleeve 242. In a specific implementation, the outer tube 31 can be fixed to the distal end of the middle core rod 26 by screwing, clamping, heat staking or other means. Correspondingly, the first limiting portion 262 is also located on the portion of the middle core rod 26 that protrudes out of the distal end of the first sleeve 242, so as to limit the first sleeve 242 on the middle core rod 26.

[0106] In an embodiment, the rod body 260 of the middle core rod 26 has a wire slot formed on the proximal end portion thereof. In the example shown in FIG. 6, the proximal end portion of the rod body 260 has a second wire slot 266 extending from the proximal end of the rod body 260 towards the distal end and terminating between the third limiting portion 264 and the clamping portion 261, so as to form an opening for the electrode lead 230 to pass through between the third limiting portion 264 and the clamping portion 261. Specifically, in the direction from the proximal end towards the distal end, the distal end of the second wire slot 266 is located between the third limiting portion 264 and the clamping portion 261, i.e., the distal end of the second wire slot 266 cannot reach the third limiting portion 264 when the traction block of the axial driving mechanism 250 is axially displaced. Thus, a gap is left between the distal end of the second wire slot 266 and the third limiting portion 264, for the electrode lead from the electrode assembly at the distal end of the ablation catheter 30 to pass through and be electrically connected to the electrode connector 23 provided at the proximal end of the handle body 21.

[0107] In an embodiment, the distal end of the first sleeve 242 exposes the first accommodating space 213 of the handle body 21 to combine with the angle knob 243, and in this embodiment, the first sleeve 242 and the angle knob 243 are coaxially arranged. A fixing hole 2420 is formed on the side wall of the distal end of the sleeve, and correspondingly, a fixing hole 2430 is formed on the angle knob 243 corresponding to the position of the fixing hole 2430. In an embodiment, the fixing hole 2420 or 2430 is, for example, a screw hole, which is used to fix the angle knob 243 to the distal end of the first sleeve 242 by combining a screw or a bolt with the screw hole. In this embodiment, the inner distal end of the angle knob 243 is formed with a counterbore structure for combining with the distal end of the middle core rod 26 protruding out of the distal end of the first sleeve 242.

[0108] In an embodiment, the distal end of the handle body 21 is a tightening port structure, and the distal end of the first accommodating space 213 has a sleeve clamping groove (not shown), and correspondingly, the outer side wall of the first sleeve 242 is provided with a clamping strip 2421 corresponding to the sleeve clamping groove, so as to limit a part of the first sleeve 242 in the first accommodating space 213, thereby avoiding the first sleeve 242 from being axially separated from the handle body 21.

[0109] The angle driving mechanism 240 is used to drive the traction line 27 from the distal end of the ablation catheter 30 (the distal end of the outer tube 31 and / or the inner tube 32) by the axial movement of the internal components, so as to make the distal end of the ablation catheter 30 change direction, so that the electrode assembly at the distal end of the ablation catheter 30 can better approach the target tissue.

[0110] In an embodiment, the angle driving mechanism 240 includes a first traction member 241 and a first sleeve 242. In this embodiment, the first traction member 241 is slidably sleeved between the second limiting portion 263 and the clamping portion 261 of the middle core rod 26, and can be axially displaced between the second limiting portion 263 and the clamping portion 261 when being driven; the first sleeve 242 is sleeved between the first limiting portion 262 and the clamping portion 261 of the middle core rod 26, so as to limit the sleeve to only rotate relative to the middle core rod 26 and cannot be axially displaced.

[0111] The first traction member 241 is sleeved on the middle core rod 26 in a slidable manner. In the embodiment, the first traction member 241 comprises a first spiral part 2411 and a traction part 2414, and specifically, the first spiral part 2411 and the traction part 2414 are integrally formed. The first spiral part 2411 is a spiral ring with external threads. The traction part 2414 is a sleeve integrally formed with the spiral ring. A protrusion 2416 is formed on the outer wall of the sleeve corresponding to the angle or direction of the first wire slot 265. A second wire hole 2415 is arranged on the protrusion 2416 for fixing the traction wire 27 from the distal end of the ablation catheter 30 (the distal end of the outer tube 31 and / or the inner tube 32) for bending adjustment. Specifically, the overall cross section of the first traction member 241 is in a T-shaped structure.

[0112] In the embodiment, in order to finally reach the protrusion 2416 from the traction wire 27 from the distal end of the ablation catheter 30 for bending adjustment, as described above, the first wire slot 265 is arranged on the rod body 260 between the distal end of the rod body 260 and the second limiting part 263. The first wire hole 2413 for the traction wire 27 is arranged on the first spiral part 2411 of the first traction member 241. The traction wire 27 reaches the second wire hole 2415 arranged on the traction part 2414 through the lumen of the ablation catheter 30, the first wire slot 265 and the first wire hole 2413, and is fixed on the protrusion 2416 of the traction part 2414. When the first traction member 241 moves linearly in the axial direction on the middle core rod 26, the traction wire 27 is pulled or relaxed, thereby achieving the purpose of bending or releasing the traction of the distal end of the ablation catheter 30. In the assembly of the angle driving mechanism 240 in the embodiment, the positions of the first wire slot 265, the first wire hole 2413 and the second wire hole 2415 are located on the same straight line.

[0113] In the embodiment, the linear guide rail 267 is arranged on the rod body 260 between the second limiting part 263 and the clamping part 261 of the middle core rod 26. The linear guide rail 267 is one or two linear protruding ribs integrally formed on the side wall of the rod body 260 of the middle core rod 26. Correspondingly, the inner wall of the first traction member 241 has a guide groove corresponding to the linear guide rail 267. Through the combination of the guide groove and the linear guide rail 267, the first traction member 241 does not rotate when moving in the axial direction on the rod body 260 of the middle core rod 26, thereby ensuring the stability of the linear motion.

[0114] In the embodiment, the first sleeve 242 is sleeved between the first limiting portion 262 and the clamping portion 261 of the middle core rod 26, and the distal end of the first sleeve 242 is fixedly connected with the angle knob 243, so as to drive the first sleeve 242 to rotate when the angle knob 243 rotates. The inner wall of the barrel of the first sleeve 242 is formed with internal threads corresponding to the external threads of the first helical portion 2411, so as to drive the first traction member 241 screwed therein to displace between the second limiting portion 263 and the clamping portion 261 when the angle knob 243 drives the first sleeve 242 to rotate. In a specific implementation, the first traction member 241 is screwed into the first sleeve 242 through the first helical portion 2411, and the first traction member 241 can move linearly in the axial direction of the first sleeve 242 due to the helical action of the internal and external threads when the first sleeve 242 rotates.

[0115] In the embodiment, the angle knob 243 is provided with a first operation portion 2431, which is a non-slip structure integrally formed on the angle knob 243 or a non-slip material wrapped on the angle knob 243 in a specific implementation. In an exemplary embodiment, the non-slip structure on the first operation portion 2431 is a protruding rib, and the interval of the rib is uniform. When an operator operates the angle knob 243, the operator can perceive the degree of traction of the traction wire 27 and the degree of bending of the distal end of the ablation catheter 30 by tactile perception of the rotating rib.

[0116] Please refer to Figure 12 , which is an exploded schematic view of an embodiment of the axial driving mechanism of the present application. As shown in the figure, in the embodiment, the axial driving mechanism 250 drives the inner tube 32 to move axially relative to the outer tube 31 by controlling the axial movement of the internal elements, so that the electrode assembly fixed between the distal end of the outer tube 31 and the distal end of the inner tube 32 is expanded / dilated / inflated and contracted. In an embodiment, the axial driving mechanism 250 includes a second traction member 251 and a second sleeve 252.

[0117] The second traction member 251 is slidably arranged between the third limiting portion 264 of the middle core rod 26 and the proximal end of the rod body 260, that is, the second traction member 251 can move axially between the third limiting portion 264 of the middle core rod 26 and the proximal end of the rod body 260. In the embodiment, the proximal end of the inner tube 32 is fixed on the second traction member 251, so as to pull or push the inner tube 32 to move axially when the second traction member 251 moves axially on the rod body 260.

[0118] In the embodiment, the second traction member 251 comprises a second screw portion 2511 and a fixing tube 2512, wherein the second screw portion 2511 is externally threaded, and the fixing tube 2512 is integrally formed with the second screw portion 2511, and specifically, the fixing tube 2512 is a tubular structure. Specifically, the overall cross section of the second traction member 251 is in a T-shaped structure.

[0119] In the embodiment, the middle core rod 26 comprises two symmetrical columnar structures at a section of the middle core rod 26 proximal to the third limiting portion 264, and a second wire slot 266 is formed between the two symmetrical columnar structures. Correspondingly, the second traction member 251 has two crescent-shaped holes (not shown) for respectively penetrating the two symmetrical columnar structures of the rod body 260, so that the second traction member 251 is in a linear motion state when it moves axially on the middle core rod 26, in other words, the two symmetrical columnar structures of the rod body 260 are inserted into the two crescent-shaped holes of the second traction member 251, and the second traction member 251 is limited from rotating relative to the rod body 260 and can only move linearly relative to the rod body 260. In the embodiment, the fixing tube 2512 of the second traction member 251 is located in the space between the two symmetrical columnar structures, that is, the fixing tube 2512 of the second traction member 251 has a smaller diameter than the rod body 260.

[0120] In the embodiment, the second wire slot 266 extends from the proximal end of the rod body 260 to the distal end and terminates between the third limiting portion 264 and the clamping portion 261, so as to form an opening for the electrode lead wire 230 to pass through between the third limiting portion 264 and the clamping portion 261. Specifically, in the direction from the proximal end to the distal end, the distal end of the second wire slot 266 is located beyond the third limiting portion 264, that is, the distal end of the second wire slot 266 is located between the third limiting portion 264 and the clamping portion 261, in other words, when the traction block of the axial driving mechanism 250 is axially displaced, it cannot reach the distal end of the second wire slot 266 due to the presence of the third limiting portion 264, so that a gap g is left between the distal end of the second wire slot 266 and the third limiting portion 264, which is used for the electrode lead wire 230 from the distal electrode assembly of the ablation catheter 30 to pass through.

[0121] In the embodiment, the second helical part 2511 of the second traction member 251 is provided with a through hole 2513 for the electrode lead 230 to pass through, so that the electrode lead 230 from the distal electrode assembly of the ablation catheter 30 passes through the channel between the outer tube 31 and the inner tube 32, and then passes out through the distal gap g of the second wire slot 266, and then passes through the through hole of the second helical part 2511, and finally reaches and is electrically connected to the electrode connector 23 at the proximal end of the handle body 21. The second helical part 2511 has a central hole for the inner tube 32 of the ablation catheter 30 to pass through and be fixed on the distal fixing tube 2512.

[0122] In the embodiment, the second sleeve 252 is sleeved between the third limiting part 264 of the middle core rod 26 and the proximal end of the rod body 260, and the inner wall of the barrel of the second sleeve 252 is formed with internal threads corresponding to the external threads of the second helical part 2511, so that the second traction member 251 screwed therein is driven to move axially on the rod body 260 by the rotation of the second sleeve 252, and then drives the inner tube 32 fixed on the second traction member 251 to move axially.

[0123] In the embodiment, the knob 253 is integrally formed at the proximal end of the second sleeve 252 to drive the second sleeve 252 to rotate when being pushed. That is, when the angle knob 243 drives the first sleeve 242 to rotate, the second traction member 251 screwed therein is driven to move axially between the third limiting part 264 and the proximal end of the rod body 260. Specifically, the second sleeve 252 has a T-shaped structure in cross section, and the T-shaped direction of the second traction member 251 with a T-shaped cross section is opposite to the T-shaped direction of the second sleeve 252 with a T-shaped cross section when the second sleeve 252 and the second traction member 251 are assembled in the handle body 21.

[0124] In the embodiment, the second accommodating space 214 formed in the first shell 211 and the second shell 212 is an open space to expose part of the knob 253 arranged therein. Specifically, in the embodiment, half of the knob 253 is exposed outside the second accommodating space 214 or the handle body 21 for easy operation, so that the knob 253 is operated by pushing.

[0125] In an embodiment, the knob 253 arranged in the open space of the second accommodating space 214 is located at the position of 1 / 3 of the side close to the proximal end of the handle body 21, that is, the compartment 216 is closer to the side of the proximal end of the handle body 21 from the whole handle body 21.

[0126] In an embodiment, the knob 253 is provided with a second operation part 2531, in a specific implementation, the second operation part 2531 is an anti-slip structure integrally formed on the knob 253 or an anti-slip material wrapped on the knob 253. In an exemplary embodiment, the anti-slip structure on the second operation part 2531 is a protruding rib, and the interval of the ribs is uniform. When the operator rotates the knob 253, the operator can perceive the degree of axial pulling or pushing of the inner tube 32 by the tactile perception of the rotating ribs, and further perceive the degree of expansion of the electrode assembly at the distal end of the ablation catheter 30.

[0127] Please refer to Figure 13 , which shows a schematic diagram of an embodiment of the operating handle of the present application equipped with an angle control assembly and an axial driving mechanism. As shown in the figure, the angle control assembly 240 and the axial movement assembly 250 are configured in a single handle 20 through a middle core rod by the unique configuration mode and mechanism design of the mechanical assembly of the present application. This not only optimizes the design of the traditional ablation pulse operating handle, but also provides smaller operation difficulty for the operator, especially the doctor in the operation, thereby facilitating the operation and precision control.

[0128] As disclosed in the above embodiment, the electrode connector 23 installed in the third accommodating space 215 of the proximal end portion of the operating handle 20 is electrically connected to the control device or delivery console through a cable. The operating handle 20 is connected to the ablation catheter 30, and the ablation catheter 30 is extended from the distal end of the handle body 21. During use, when it is necessary to change the direction of the distal end of the ablation catheter 30, for example, when the ablation catheter 30 enters the human body, it is necessary to change the direction of the distal end of the ablation catheter 30 so that the electrode assembly at the distal end of the ablation catheter 30 can better approach the target tissue. The operator rotates the angle knob 243 arranged at the distal end of the handle body 21, and the angle knob 243 drives the first traction member 241 of the angle driving mechanism 240 to axially displace in the first sleeve 242. Since the proximal end of the traction line 27 is fixed on the first traction member 241, the axial displacement of the first traction member 241 will pull or release the traction line 27, thereby realizing the directional adjustment of the distal end of the ablation catheter 30 at the distal end of the traction line.

[0129] In the surgery, when the positioning of the target tissue is completed or the electrode assembly at the distal end of the ablation catheter 30 reaches the target position, one of the diagnosis, measurement and treatment needs to be performed, and the electrode assembly in the contracted state needs to be released from the ablation catheter 30 and expanded from the contracted state to the expanded state. At this time, the operator needs to pull the knob 253 exposed to a part of the handle body 21, and the knob 253 drives the second traction member 251 of the axial driving mechanism 250 to axially displace in the second sleeve 252 when the knob 253 rotates. Since the proximal end of the inner tube 32 is fixed to the second traction member 251, the inner tube 32 is also axially displaced when the second traction member 251 is axially displaced. Since the plurality of electrode elements in the electrode assembly are fixed between the distal end of the outer tube 31 and the distal end of the inner tube 32, the relative movement of the inner tube 32 and the outer tube 31 causes the plurality of electrode elements in the electrode assembly to switch between the contracted state and the expanded state.

[0130] As described above, the operation handle of the pulse ablation device and the ablation catheter of the present application is configured on different operation handles relative to the mechanism for driving the bending of the ablation electrode and the mechanism for driving the expansion or contraction of the ablation electrode in the prior art. The present application realizes both the bending function of the ablation catheter and the control of the expansion and contraction of the electrode ball on a single handle body. The present application configures the angle control assembly and the axial movement assembly through a middle core rod in a single handle through a unique configuration mode and mechanism design, which not only optimizes the design of the traditional operation handle of the ablation pulse, but also provides smaller operation difficulty for professionals, especially doctors, in the application in the surgery, thereby facilitating the surgery and the control of the precision.

[0131] 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 made 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, which comprises 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; a middle core rod in a hollow structure is arranged for connecting the outer tube and the inner tube of the ablation catheter; an electrode assembly is arranged between the outer tube and the inner tube of the ablation catheter, and each electrode element of the electrode assembly comprises a proximal end structure fixed to the distal end of the outer tube and a distal end structure fixed to the distal end of the inner tube; an operation handle is arranged for connecting the ablation catheter, and the operation handle comprises a handle body, an angle control assembly arranged on the handle body and used for controlling the angle turning of the distal end of the ablation catheter, and an axial movement assembly used for driving the inner tube to move relative to the outer tube so as to switch the plurality of electrode elements between a contraction state and an expansion state; the operation handle comprises the handle body formed with an external holding part, a first accommodating space formed in the interior of the handle body and located at a distal end part, and a second accommodating space formed in the interior of the handle body and located at a proximal end part; a compartment for clamping the middle core rod is arranged between the first accommodating space and the second accommodating space in the handle body; the middle core rod comprises a hollow rod body and a clamping part arranged in the middle of the rod body and clamped in the compartment so as to clamp the rod body in the handle body; the rod body comprises a first limiting part arranged at the distal end of the rod body and a second limiting part arranged between the first limiting part and the clamping part; the angle control assembly comprises an angle driving mechanism arranged in the first accommodating space and an angle knob fixedly connected with the angle driving mechanism and arranged at the distal end of the handle body; the angle driving mechanism comprises a first traction part slidably sleeved between the second limiting part and the clamping part of the middle core rod, a first screw part provided with external threads, and a traction part integrally formed with the first screw part; a first sleeve is sleeved between the first limiting part and the clamping part of the middle core rod, and the distal end of the first sleeve is fixedly connected with the angle knob; an internal thread is formed on the inner wall of the cylinder body of the first sleeve and corresponds to the external threads of the first screw part, so that when the angle knob drives the first sleeve to rotate, the first traction part screwed in the first sleeve is driven to move between the second limiting part and the clamping part; the axial movement assembly comprises an axial driving mechanism arranged in the second accommodating space and fixedly connected with the proximal end of the inner tube, and a knob partially arranged in the second accommodating space and used for operating the axial movement of the axial driving mechanism; a guide wire hole is arranged in the side wall of the handle body and corresponds to the second accommodating space, so that a guide wire can enter the handle body from the guide wire hole; the guide wire hole is arranged near the proximal end of the handle body; the handle body comprises a first shell and a second shell clamped and connected with the first shell, wherein the first accommodating space formed in the first shell and the second shell is a closed space, and the second accommodating space formed in the first shell and the second shell is an open space so as to expose a part of the knob arranged in the second accommodating space. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 2. The pulsed ablation device of claim 1, wherein, ​ 3. The pulsed ablation device of claim 2, wherein, ​ 4. The pulsed ablation device of claim 3, wherein, ​ 5. The pulsed ablation device of claim 4, wherein, A proximal end cover is arranged on the proximal end of the handle body to fix the proximal ends of the first and second housings.

6. The pulsed ablation device of claim 1, wherein, The knob arranged in the open space of the second accommodating space is located at the position of 1 / 3 of the side of the handle body close to the proximal end.

7. The pulsed ablation device of claim 1, wherein, A third accommodating space is formed in the handle body and located at the proximal end of the handle body to accommodate an electrode connector electrically connected to the electrode assembly through an electrode lead.

8. The pulsed ablation device of claim 1, wherein, The middle core rod is also used to arrange the angle driving mechanism in the first accommodating space and the axial driving mechanism in the second accommodating space.

9. The pulsed ablation device of claim 8, wherein, The proximal end of the outer tube is fixed in the middle core rod, and the proximal end of the inner tube is fixedly connected to the axial driving mechanism.

10. The pulsed ablation device of claim 9, wherein, The compartment is provided with a clamping structure to clamp the middle core rod in the handle body.

11. The pulsed ablation device of claim 10, wherein, The compartment is located at the position of 1 / 3 of the side of the handle body close to the distal end.

12. The pulsed ablation device of claim 11, wherein, The rod body further comprises a third limiting portion arranged between the clamping portion and the proximal end of the rod body.

13. The pulsed ablation device of claim 12, wherein, The first limiting portion and / or the second limiting portion are clamping grooves arranged on the rod body to cooperate with a clamping ring or a clamping card; and the third limiting portion is a protrusion integrally formed on the rod body.

14. The pulsed ablation device of claim 13, wherein, A first wire slot is arranged on the rod body between the distal end of the rod body and the second limiting portion to pass through a traction line.

15. The pulsed ablation device of claim 14, wherein, The proximal end portion of the rod body has a second wire slot extending from the proximal end of the rod body towards the distal end and terminating between the third limiting portion and the clamping portion to form an opening for the electrode lead to pass through between the third limiting portion and the clamping portion.

16. The pulsed ablation device of claim 15, wherein, The distal end of the middle core rod protrudes out of the distal end of the first sleeve and is located in the angle knob.

17. The pulsed ablation device of claim 16, wherein, A linear guide rail is arranged on the rod body between the second limiting portion and the clamping portion, and the inner wall of the first traction member has a guide groove corresponding to the linear guide rail.

18. The pulsed ablation device of claim 16, wherein, A first wire hole is arranged on the first spiral portion for the traction line from the distal end of the outer tube and / or the inner tube to pass through.

19. The pulsed ablation device of claim 16, wherein, A second wire hole is arranged on the traction portion to fix the traction line from the distal end of the outer tube and / or the inner tube.

20. The pulsed ablation device of claim 16, wherein, The distal end of the first sleeve exposes the first accommodating space of the handle body to combine the angle knob.

21. The pulsed ablation device of claim 16, wherein, The distal end of the first accommodating space has a sleeve clamping groove, and the outer side wall of the first sleeve is provided with a clamping strip corresponding to the sleeve clamping groove to limit a part of the first sleeve in the first accommodating space.

22. The pulsed ablation device of claim 8, wherein, The axial driving mechanism comprises: A second traction member is slidably arranged between the third limiting portion of the middle core rod and the proximal end of the rod body, and comprises a second spiral portion provided with external threads and a fixing tube integrally formed with the second spiral portion; A second sleeve is arranged between the third limiting portion of the middle core rod and the proximal end of the rod body, and the inner wall of the barrel of the second sleeve is formed with internal threads corresponding to the external threads of the second spiral portion, so that when the angle knob drives the first sleeve to rotate, the second traction member screwed therein is displaced between the third limiting portion and the proximal end of the rod body.

23. The pulsed ablation device of claim 22, wherein, The knob is integrally formed at the proximal end of the second sleeve to drive the second sleeve to rotate when being pushed.

24. The pulsed ablation device of claim 22, wherein, The middle core rod has two symmetrical column piece structures from the third limiting part to the proximal end section, and a second wire slot is formed between the two symmetrical column piece structures.

25. The pulsed ablation device of claim 22, wherein, The second traction member has two crescent-shaped holes for the two symmetrical column piece structures on the rod body.

26. The pulsed ablation device of claim 22, wherein, The proximal end of the inner tube is fixed on the fixed tube of the second traction member.

27. The pulsed ablation device of claim 22, wherein, A through hole is formed on the second spiral part of the second traction member for the electrode lead wire to pass through.

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