Pulsed field ablation catheter and apparatus

Abstract

The embodiment of the present application discloses a kind of pulse field ablation catheter and equipment.Pulse field ablation catheter includes inner tube and elastic deformation body;The elastic deformation body is arranged at the front end of the inner tube, and at least one end of the elastic deformation body is fixedly connected with the inner tube;The middle part of the elastic deformation body can expand or contract, and when the elastic deformation body contracts, the inner surface of the elastic deformation body at least partially matches the inner tube.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a pulse field ablation catheter and device. BACKGROUND

[0002] Pulse field ablation (PFA) is a technology that uses high-voltage discharge to cause irreversible electroporation of cells, which can directly act on cells to cause apoptosis to achieve a therapeutic purpose. The irreversible electroporation ablation technology used by pulse field ablation is a non-heating ablation technology, which has some theoretical advantages compared with other ablation methods. First, the ablation time of irreversible electroporation is very short; second, since irreversible electroporation is a non-thermal ablation, there is no heat sink effect, and complete cell death can be produced around blood vessels; third, irreversible electroporation can ablate living cells, which theoretically preserves the cell matrix and the structure around the cells; in addition, when using irreversible electroporation to ablate the edge or top of a lesion, the possibility of indirect damage to nearby structures is very small. At the same time, the mechanism by which irreversible electroporation causes cell death is apoptosis, rather than necrosis. The advantage of cell apoptosis is that the apoptotic cells are removed by immune intervention, and the phagocytic cells remove the apoptotic cells as a normal cell death process, thereby promoting the regeneration and repair of normal tissues, so that the treatment area can be replaced by normal cells in a short time after irreversible electroporation treatment to restore the original function. SUMMARY

[0003] One of the embodiments of the present application provides a pulse field ablation catheter, comprising an inner tube and an elastic deformation body; the elastic deformation body is arranged at the front end of the inner tube, at least one end of the elastic deformation body is fixedly connected with the inner tube; the middle part of the elastic deformation body can expand or contract, and when the elastic deformation body contracts, the inner surface of the elastic deformation body at least partially matches the inner tube.

[0004] One of the embodiments of the present application provides a pulse field ablation device, comprising a pulse field ablation catheter and a control handle; the pulse field ablation catheter comprises an inner tube, an elastic deformation body and an outer tube; the elastic deformation body is arranged at the front end of the inner tube, at least one end of the elastic deformation body is fixedly connected with the inner tube, and the middle part of the elastic deformation body can expand or contract; when the elastic deformation body contracts, the inner surface of the elastic deformation body at least partially matches the inner tube; the outer tube is sleeved outside the inner tube, and the inner tube can move relative to the outer tube; the control handle is used to control the relative movement of the inner tube and the outer tube to control the expansion or contraction of the middle part of the elastic deformation body. BRIEF DESCRIPTION OF DRAWINGS

[0005] The present application will be further illustrated in the manner of exemplary embodiments, which will be described in detail with reference to the accompanying drawings. These embodiments are not restrictive, and in these embodiments, the same reference numbers represent the same structures, in which:

[0006] Figure 1 is a schematic diagram of the overall structure of a pulse field ablation catheter and device according to some embodiments of the present application;

[0007] Figure 2 is a schematic diagram of the structure of a pulse field ablation catheter with an elastic deformation body in a contracted state according to some embodiments of the present application;

[0008] Figure 3 is a schematic diagram of the overall structure of a pulse field ablation catheter and device according to another embodiment of the present application;

[0009] Figure 4 is a schematic diagram of the structure of a pulse field ablation catheter with an elastic deformation body in an expanded state according to another embodiment of the present application;

[0010] Figure 5 is a schematic diagram of a pulse field ablation scene according to some embodiments of the present application;

[0011] Figure 6 is a schematic diagram of a pulse field ablation scene according to another embodiment of the present application;

[0012] Figure 7 is a schematic diagram of a pulse field ablation catheter and ablation scene according to yet another embodiment of the present application;

[0013] Figure 8 is a schematic diagram of the structure of a control handle containing a bending control mechanism according to some embodiments of the present application;

[0014] Figure 9 is a schematic diagram of the structure of a left rotation of a bending control mechanism according to some embodiments of the present application;

[0015] Figure 10 is a schematic diagram of the structure of a right rotation of a bending control mechanism according to some embodiments of the present application;

[0016] Figure 11 is an exemplary flowchart of a pulse field ablation control method according to some embodiments of the present application;

[0017] Figure 12 is a module diagram of a pulse field ablation control system according to some embodiments of the present application;

[0018] Figure 13 is an exemplary flowchart of a lesion tissue feature determination model training method according to some embodiments of the present application;

[0019] Figure 14 is an example flowchart of an ablation parameter determination model training method according to some embodiments of the present application.

[0020] In the figure, 1 is the front end of the inner tube, 2 is the outer tube, 3 is the control handle, 31 is the control button, 31' is the control button in the rear end state, 31a is the control button in the rear end state, 4 is the cable plug, 11 is the inner tube, 12 is the elastic deformation body, 121 is the front end fixed ring, 122 is the rear end fixed ring, 131 is the No. 1 electrode, 132 is the No. 2 electrode, 133 is the No. 3 electrode, 134 is the No. 4 electrode, 5 is the bronchoscope, 51 is the inner tube channel, 6 is the tissue lumen, 61 is the lesion tissue, 7 is the control bending knob, 7a is the control bending knob left rotation state, 7b is the control bending knob right rotation state, 11a is the inner tube left bending state, 11b is the inner tube right bending state, 2a is the outer tube left bending state, 2b is the outer tube right bending state, 12a is the first elastic deformation body, 12b is the second elastic deformation body, 13c is the No. 5 electrode, 13d is the No. 6 electrode, and 14 is the pulsed field region. DETAILED DESCRIPTION

[0021] In order to make the purpose, technical solutions and advantages of the present application clearer, the present application is further described in detail below in combination with the drawings and examples. It should be understood that the specific examples described herein are only used to explain the present application and are not used to limit the present application. On the contrary, the present application covers any alternative, modification, equivalent method and solution defined by the claims within the essence and scope of the present application. Further, in order for the public to have a better understanding of the present application, some specific details are described in the following detailed description of the present application. The present application can also be completely understood without the description of these details by those skilled in the art.

[0022] Since the position of the product of the present application can be changed at will, the relative positional relationship is indicated by the relative positional relationship, and the absolute positional relationship is not limited by the relative positional relationship. In addition, the "front end" in the present application refers to the end far from the surgeon, and the "rear end" refers to the end close to the surgeon.

[0023] The flowchart is used to illustrate the operations performed by the system according to the embodiments of the present application. It should be understood that the operations before or after the flowchart are not necessarily executed in sequence. On the contrary, each step can be processed in reverse order or simultaneously. At the same time, other operations can be added to these processes, or one or more steps of operations can be removed from these processes.

[0024] Embodiments of the present application relate to a pulsed field ablation catheter and device. The pulsed field ablation catheter and device can be used for ablation of diseased tissue. In some embodiments, the pulsed field ablation catheter and device can be used for ablation of various diseased tissues (e.g., lesions) in different parts of the human body. For example, the pulsed field ablation catheter and device can be used for ablation of lesions in the trachea, bronchus, intestinal tract (e.g., large intestine, small intestine, duodenum, etc.), gallbladder, heart, etc. For another example, the pulsed field ablation catheter and device can be used for ablation of lesions related to bronchitis, emphysema, bronchial gland hyperplasia, atrial fibrillation, local hyperplastic tumors, etc. The ablation principle of the pulsed field ablation catheter and device will be described below with the example of chronic obstructive pulmonary disease (COPD).

[0025] Chronic obstructive pulmonary disease (COPD) is a common chronic disease characterized by airflow obstruction, chronic bronchitis and / or emphysema, which can further develop into pulmonary heart disease and respiratory failure. Clinical studies have found that inflammatory cells such as neutrophils, macrophages and T lymphocytes are involved in the pathogenesis of COPD, and chronic inflammation of the airway, lung parenchyma and pulmonary vessels is a distinct feature of COPD. Activation and aggregation of neutrophils is an important link in the inflammatory process of COPD, which causes chronic mucus hypersecretion and destroys lung parenchyma by releasing neutrophil elastase, neutrophil cathepsin G, neutrophil proteinase 3 and matrix metalloproteinase.

[0026] Inflammation of the tissue is an important factor in the development of COPD. COPD pathological changes mainly manifested as chronic bronchitis and emphysema. Bronchial mucosa epithelial cell degeneration, necrosis, ulcer formation. Cilia inverted, short, uneven, adhesion, partial shedding. Remission period of mucosal epithelial repair, hyperplasia, squamous epithelial metaplasia and granuloma formation. The number of goblet cells increased hypertrophy, hypersecretion, intracavity secretion storage. Basement membrane thickening necrosis. Bronchial gland hyperplasia, gland hypertrophy and bronchial wall thickness ratio is often greater than 0.55-0.79 (normal less than 0.4). All levels of bronchial wall have a variety of inflammatory cell infiltration, mainly neutrophils and lymphocytes. Acute exacerbations can be seen in a large number of neutrophils, severe purulent inflammation, mucosal congestion, edema, degeneration and necrosis and ulcer formation, basement granuloma tissue and fibrous tissue proliferation leading to stenosis. Inflammation leads to airway wall damage-repair process repeatedly, and then cause airway remodeling, collagen content and scar formation, these pathological changes are one of the main pathological basis of airflow limitation in COPD. Emphysema pathological changes can be seen in the lung overexpansion, decreased elasticity. Gray or pale appearance, the surface can be seen in a number of different size of the large bulla. Microscopy showed that the alveolar wall thinning, alveolar cavity expansion, rupture or form a large bulla, reduced blood supply, elastic fiber network destruction. Bronchioles have inflammatory cell infiltration, bronchial gland and goblet cell hyperplasia, hypertrophy, ciliary epithelial damage, cilia reduction. Some of the lumen is thin or twisted expansion, lumen with sputum retention. Bronchioles intima can be thickened or occluded.

[0027] According to the site of the involved pulmonary lobule, obstructive emphysema can be divided into three types: lobular central type, whole lobular type and mixed type between the two. Among them, the lobular central type is more common. Lobular central type is due to inflammation of terminal bronchioles or primary respiratory bronchioles, which causes lumen stenosis, and the distal secondary respiratory bronchioles are cystic dilatation. Its characteristic is that the cystic dilatation of the respiratory bronchioles is located in the central area of the secondary lobule. The whole lobular type is the stenosis of the respiratory bronchioles, which causes the expansion of the terminal lung tissue, i.e. alveolar duct, alveolar sac and alveoli. Its characteristic is that the emphysema cystic cavity is small and distributed in the pulmonary lobule. Sometimes both types exist in a lung, which is called mixed emphysema. It is usually based on the lobular central type and complicated by the expansion of the peripheral lung tissue of the lobule.

[0028] The clinical manifestations of chronic obstructive pulmonary disease are airway stenosis and occlusion in the lung, forming a lung bulla to block the airway. In surgical treatment, the clinician generally uses a bronchoscope and surgical instruments to remove the lung bulla, but postoperative acute exacerbation of chronic obstructive pulmonary disease, pneumonia and hemoptysis are relatively common, and the patient's life cannot be prolonged. In the treatment of chronic obstructive pulmonary disease (COPD), radiofrequency ablation technology is also used, that is, cold ablation or hot ablation of the lesion tissue, but it will damage the airway. For example, by high temperature, the protein tissue at the airway is denatured, so as to achieve the effect of ablation of the lesion tissue, but high temperature in the ablation process may cause carbonization of the airway, and the airway is burned and collapsed.

[0029] The pulse field ablation catheter and device according to the embodiments of the present application can ablate the lesions inside the human bronchus. Unlike surgical resection and surgical ablation (such as microwave and radiofrequency), the access to the lung of the human body that the pulse field ablation catheter can adopt is the human upper respiratory tract bronchus, so it will not penetrate the bronchus and lung lobe, will not form pneumothorax, and will not cause needle channel burns, hemoptysis, pleural effusion, pneumonia and other complications. The pulse field ablation catheter of the embodiments of the present application has a flexible and deformable elastic mesh support member (such as an elastic deformation body), which can adapt to the lumen structure of the lung bronchus and bronchus, so that when the ablation electrode is arranged at the periphery of the lesion bronchus, the electrode can still maintain relative static with the lesion when the person is breathing. The hollow mesh support member has elasticity and can adapt to the lumen of the human body tissue. The hollow spherical mesh support structure can be more conducive to the positioning of the catheter. The elastic mesh support member (such as the elastic deformation body) can be expanded to contact and support the lesion tissue in the bronchus. The hollow elastic deformation body can allow the tissue fluid in the human bronchus to seep into contact with the electrode. In some embodiments, the electrode (or part of the electrode) is arranged in the middle of the elastic deformation body. After the elastic deformation body is expanded, the electrode is naturally arranged at the central part of the lesion tissue. Through high-voltage discharge, the non-contact electric field energy covers the lesion tissue, and ablation can be achieved without needing to contact the lesion tissue as in radiofrequency ablation. The high-voltage electric field has selectivity to the lesion tissue, and the non-lesion tissue will not be ablated when passing through the high-voltage electric field. Neutrophils, macrophages, T lymphocytes and other inflammatory cells are involved in the pathogenesis of COPD, and such cells are more sensitive to electric fields and are more likely to absorb electric field energy and be ablated. Therefore, the pulse field ablation catheter and device of the embodiments of the present application can directly act on the lesion tissue in the lung bronchus, effectively achieve the treatment of COPD, and at the same time, since the pulse field ablation does not generate high temperature, it will not cause carbonization or collapse of the airway.

[0030] Figure 1 It is a schematic diagram of the overall structure of the pulse field ablation catheter and device according to some embodiments of the present application; Figure 2 It is a schematic diagram of the structure of the pulse field ablation catheter with the elastic deformation body in the contracted state according to some embodiments of the present application;Figure 3 is a schematic diagram of the overall structure of a pulse field ablation catheter and device according to another embodiment of the present application; Figure 4 is a schematic diagram of the structure of a pulse field ablation catheter in which the elastic deformation body is in an expanded state according to another embodiment of the present application; Figure 5 is a schematic diagram of a pulse field ablation scene according to some embodiments of the present application; Figure 6 is a schematic diagram of a pulse field ablation scene according to another embodiment of the present application; Figure 7 is a schematic diagram of a pulse field ablation catheter and ablation scene according to yet another embodiment of the present application. The following will be described in combination with the accompanying drawings Figures 1-7 The pulse field ablation catheter and device according to the embodiments of the present application will be described in detail. It should be noted that the following embodiments are merely used to explain the present application and do not constitute a limitation of the present application.

[0031] Figure 1 is a schematic diagram of the overall structure of a pulse field ablation catheter and device according to some embodiments of the present application, in which the front end of the inner tube 1 is enlarged. In some embodiments, as shown in Figure 1 , the pulse field ablation catheter can include an inner tube 11 and an elastic deformation body 12. The elastic deformation body 12 is arranged at the front end of the inner tube 11, where the front end can refer to the end away from the operator. In some embodiments, at least one end of the elastic deformation body 12 is fixedly connected to the inner tube 11. For example, at least one end of the elastic deformation body 12 can be fixedly connected to the inner tube 11 by welding, clamping, bonding, heat staking, threaded connection or one-piece forming, etc. The middle part of the elastic deformation body 12 can expand or contract, and when the elastic deformation body 12 contracts, the inner surface of the elastic deformation body 12 at least partially fits the inner tube 11. The middle part of the elastic deformation body 12 can be understood as the middle part of the elastic deformation body 12 along its length direction. As shown in Figure 2 or Figure 5 is a schematic diagram of the elastic deformation body 12 in a contracted state. In the embodiments shown in Figure 2 or Figure 5 , the inner surface of the elastic deformation body 12 can completely fit the inner tube 11 in the contracted state, so as to effectively reduce the volume of the pulse field ablation catheter when the elastic deformation body 12 is in the contracted state. In some embodiments, when the elastic deformation body 12 contracts, the inner surface of the elastic deformation body 12 can not completely fit the inner tube 11. In some embodiments, when the elastic deformation body 12 contracts, the elastic deformation body 12 can be cylindrical.

[0032] In some embodiments, the elastic deformation body 12 can be a hollow mesh structure. By setting the elastic deformation body 12 as a hollow mesh structure, liquid (such as tissue fluid) can flow into the elastic deformation body 12, thereby better achieving ablation of the diseased tissue. In addition, the hollow elastic deformation body 12 can facilitate positioning of the pulsed field ablation catheter, and facilitate observation of the diseased tissue by endoscopy, X-ray, etc. In some embodiments, the elastic deformation body 12 can be made of a material capable of elastic deformation, and the elastic deformation body 12 can expand or contract when subjected to external force. The expansion or contraction of the elastic deformation body 12 can be understood as the cross section of at least a part (such as the middle part) of the elastic deformation body 12 expanding or shrinking. In some embodiments, the material of the elastic deformation body 12 can include but is not limited to metal materials (such as spring steel, nickel-titanium alloy, etc.), plastics (such as high-elasticity nylon materials, etc.), thermoplastic elastomers (such as TPU, TPS, etc.), etc. In some embodiments, the elastic deformation body 12 can be woven from a filamentous raw material. For example, the elastic deformation body 12 can be woven from a nickel-titanium alloy wire. In some embodiments, the elastic deformation body 12 can be cut from a tubular material. For example, the elastic deformation body 12 can be cut from a nickel-titanium alloy tube by laser cutting or water cutting, etc. In some embodiments, the mesh structure and the elasticity of the elastic deformation body 12 can adapt to the lumen of the human body tissue, and can make the electrode position of the pulsed field ablation catheter correspond to the diseased tissue and remain relatively stationary, thereby enhancing the effect of ablation of the diseased tissue.

[0033] In some embodiments, the pulsed field ablation catheter can include an outer tube 2, which is sleeved outside the inner tube 11, and the inner tube 11 can move relative to the outer tube 2 (such as moving along the axis direction of the inner tube / outer tube). In some embodiments, the relative movement between the inner tube 11 and the outer tube 2 can control the expansion and / or contraction of the elastic deformation body 12 at the front end of the inner tube 11. In some embodiments, the inner tube and / or the outer tube can be made of insulating material, and the inner tube and the outer tube after being made have a certain elasticity, can be bent under force and are not easy to be deformed by bending. In some embodiments, the inner tube 11 and / or the outer tube 2 can be made of high molecular insulating material. The high molecular insulating material can include but is not limited to a combination of one or more of polyurethane (PU), polyethylene (PE), polyether block polyamide (PEBAX), etc. In some embodiments, the materials of the inner tube 11 and the outer tube 2 can be the same or different.

[0034] In some embodiments, as shown in FIG. 2, the pulsed field ablation catheter can include a handle 1, an inner tube 11, an elastic deformation body 12, an outer tube 2, and a pulsed field generator 3. The handle 1 can be connected to the inner tube 11, and the inner tube 11 can be connected to the elastic deformation body 12. The elastic deformation body 12 can be connected to the outer tube 2, and the outer tube 2 can be connected to the pulsed field generator 3. In some embodiments, the handle 1 can be connected to the inner tube 11 by a threaded connection, and the inner tube 11 can be connected to the elastic deformation body 12 by a threaded connection. In some embodiments, the elastic deformation body 12 can be connected to the outer tube 2 by a threaded connection, and the outer tube 2 can be connected to the pulsed field generator 3 by a threaded connection. Figures 1-2As shown, the two ends of the elastic deformation body 12 can be fixedly connected with the inner tube 11. The manner of fixedly connecting the two ends of the elastic deformation body 12 with the inner tube 11 can include, but is not limited to, one or more of welding, clamping, bonding, heat melting, threaded connection, etc. In some embodiments, the elastic deformation body 12 can be in an expanded state in a natural state. The middle part of the elastic deformation body 12 can automatically expand when the outer tube 2 is extended, and the middle part of the elastic deformation body 12 can automatically contract when the outer tube 2 is retracted. Wherein, the diameter of the middle part of the elastic deformation body 12 in the expanded state is greater than the diameter of the outer tube 2; the diameter of the middle part of the elastic deformation body 12 in the contracted state is less than the diameter of the outer tube 2. By fixedly connecting the two ends of the elastic deformation body 12 with the inner tube 11, the inner tube 11 and the outer tube 2 can drive the elastic deformation body 12 to extend or retract in the outer tube 2 by relative movement, so as to control the elastic deformation body 12 to automatically expand or contract, and the control mode is simple and stable. In some embodiments, when the elastic deformation body 12 is contracted, its diameter can be 0.3-3 mm (such as 0.3 mm, 0.5 mm, 0.7 mm, 1 mm, 2 mm, 3 mm, etc.). The diameter of the inner wall of the outer tube 2 can be slightly larger than the diameter of the elastic deformation body 12 when it is contracted. For example, the diameter of the inner wall of the outer tube 2 can be 0.4-3.5 mm (such as 0.4 mm, 0.6 mm, 0.8 mm, 1.2 mm, 2.2 mm, 3.5 mm, etc.). When the elastic deformation body 12 is expanded, its maximum expanded diameter can be 5-40 mm (such as 5 mm, 8 mm, 15 mm, 25 mm, 40 mm, etc.). In some embodiments, the sizes of the inner tube 11 and the outer tube, and the size of the elastic deformation body 12 can be adaptively adjusted according to the ablation site, the type of lesion tissue, the age of the patient, etc., which are not limited in the present application.

[0035] In some embodiments, as Figure 1As shown, in the expanded state, the middle portion of the elastic deformable body 12 is at least partially cylindrical, and the diameter of the cylinder gradually decreases from both ends to the ends of the elastic deformable body 12. By designing the middle portion of the elastic deformable body 12 to be at least partially cylindrical in the expanded state, the force exerted by the elastic deformable body 12 against the tissue lumen during expansion is more uniform, thus reducing the risk of damage to the tissue lumen. In some embodiments, the elastic deformable body 12 can be formed by cutting a first tube (such as a nickel-titanium alloy tube, a high-elasticity nylon tube, etc.). The diameter of the first tube can be the same as the diameter of the middle portion of the elastic deformable body 12 in the expanded state. In some embodiments, the structure after cutting the first tube can be heat-treated (e.g., heat-treated for shaping), the ends can be gathered, and the ends can be fixed to form the elastic deformable body 12. By using the first tube to cut and form the elastic deformable body 12, the middle portion of the elastic deformable body 12 can automatically expand to the diameter of the first tube (or the heat-treated and shaped structure) under its own elastic force in the expanded state. In some alternative embodiments, the diameter of the first tube may be greater than or less than the diameter of the middle portion of the elastic deformable body 12 in the expanded state. In some embodiments, the elastic deformable body 12 may be woven from filamentous raw materials (such as nickel-titanium alloy wire). In some embodiments, the elastic deformable body 12 may be formed into other shapes. In some embodiments, the elastic deformable body 12 has the largest diameter in its expanded state, and the diameter of the elastic deformable body 12 gradually decreases from the middle to both ends. In some embodiments, the shape of the elastic deformable body 12 in the expanded state may be spindle-shaped, ellipsoidal, etc.

[0036] In some embodiments, such as Figures 3-4 As shown, the front end of the elastic deformable body 12 can be fixedly connected to the inner tube 11, and the rear end of the elastic deformable body 12 can be fixedly connected to the front end of the outer tube 2. The inner tube 11 and the outer tube 2 can move relative to each other to control the expansion or contraction of the elastic deformable body 12. In some embodiments, the way the front end of the elastic deformable body 12 is fixedly connected to the inner tube 11 and the way the rear end is fixedly connected to the outer tube 2 can be, but is not limited to, welding, snap-fitting, bonding, heat fusion welding, threaded connection, or one or more combinations thereof. In some embodiments, such as Figure 3 As shown, the front end of the elastic deformable body 12 can be fixedly connected to the inner tube 11 through the front end fixing ring 121; the rear end of the elastic deformable body 12 can be fixedly connected to the front end of the outer tube 2 through the rear end fixing ring 122.

[0037] In some embodiments, such as Figure 3As shown, the rear end of the elastic deformation body 12 can be fixedly connected with the inner wall of the front end of the outer tube 2. In some embodiments, the rear end of the elastic deformation body 12 can be fixedly connected with the outer wall of the front end of the outer tube 2. In some embodiments, the rear end of the elastic deformation body 12 can be fixedly connected with the end of the front end of the outer tube 2. By fixing the front end of the elastic deformation body 12 with the inner tube 11 and the rear end of the elastic deformation body 12 with the front end of the outer tube 2, the inner tube 11 and the outer tube 2 can drive the distance between the two ends of the elastic deformation body 12 to change through relative movement. When the elastic deformation body 12 is in the contracted state, the distance between the two ends of the elastic deformation body 12 can be the largest. When the distance between the two ends of the elastic deformation body 12 gradually decreases from the largest, the elastic deformation body 12 will be squeezed so that the middle part of the elastic deformation body 12 can gradually expand. In the present embodiment, the relative movement of the inner tube 11 and the outer tube 2 can accurately control the distance between the two ends of the elastic deformation body 12, so that the expansion degree of the middle part of the elastic deformation body 12 can be accurately adjusted, and the pulse field ablation catheter can be suitable for different tissue lumens and / or lesion tissues.

[0038] In some embodiments, the elastic deformation body 12 can be cut from a second tube body (such as a nickel-titanium alloy tube, a highly elastic nylon tube, etc.), and the diameter of the second tube body can be the same as the diameter of the middle part of the elastic deformation body 12 in the contracted state. In some embodiments, the structure after cutting the second tube body can be subjected to heat treatment (such as heat treatment shaping), fixed at both ends, and the like, thereby forming the elastic deformation body 12. By cutting the elastic deformation body 12 from the second tube body, the elastic deformation body 12 can better fit the inner tube in the contracted state, thereby reducing the risk of scratching the tissue lumen during the delivery of the pulse field ablation catheter. At the same time, the diameter of the second tube body is small, which can save the manufacturing material of the elastic deformation body 12 to some extent. In some alternative embodiments, the diameter of the second tube body can be greater than or less than the diameter of the middle part of the elastic deformation body 12 in the contracted state. In some embodiments, the elastic deformation body 12 can be woven from a wire-shaped raw material (such as a nickel-titanium alloy wire). In some embodiments, the elastic deformation body 12 can be formed by extrusion, 3D printing, etc. Figure 4 As shown, the diameter of the middle part of the elastic deformation body 12 in the expanded state is the largest, and the diameter of the elastic deformation body 12 gradually decreases from the middle part to the two ends. In some embodiments, the shape of the elastic deformation body 12 in the expanded state can be spindle-shaped, ellipsoidal, etc. In some embodiments, the middle part of the elastic deformation body 12 in the expanded state can be at least partially cylindrical, and the diameter of the two ends of the cylindrical shape gradually decreases to the diameter of the two ends of the elastic deformation body 12.

[0039] In some embodiments, one end of the elastic deformable body 12 can be fixedly connected to the inner tube 11, and the other end of the elastic deformable body 12 can be movably connected relative to the inner tube 11. Specifically, the front end of the elastic deformable body 12 can be fixedly connected to the inner tube 11, and the rear end of the elastic deformable body 12 can be movably sleeved outside the inner tube 11. The elastic deformable body 12 can be in a contracted state in its natural state. In this embodiment, when the pulsed field ablation catheter is delivered into the tissue lumen, the elastic deformable body 12 can contract inside the outer tube 2 to avoid damage to the tissue lumen. When the pulsed field ablation catheter is delivered to the designated position, the inner tube 11 can move relative to the outer tube 2 to drive the elastic deformable body 12 out of the outer tube 2. After the elastic deformable body 12 extends out of the outer tube 2, the rear end of the elastic deformable body 12 (or the limiting component fixedly connected to the rear end) can engage with the front end of the outer tube 2 to prevent the elastic deformable body 12 from retracting into the outer tube 2. After the elastic deformable body 12 extends out of the outer tube 2, the relative movement between the inner tube 11 and the outer tube 2 can cause the distance between the two ends of the elastic deformable body 12 to change, thereby controlling the expansion or contraction of the elastic deformable body 12.

[0040] In some embodiments, such as Figures 1-5 As shown, at least two annular electrodes can be spaced apart on the outer side of the inner tube 11. For example, the number of electrodes spaced apart on the outer side of the inner tube 11 can include 2, 3, 4, 6, 8, etc. In some embodiments, the annular electrodes can be arranged around the outer side of the inner tube 11. The connection method between the annular electrodes and the inner tube 11 can include, but is not limited to, welding, snap-fitting, gluing, integral molding, etc. The length of the annular electrodes can be 0.4 to 20 mm (e.g., 0.4 mm, 0.6 mm, 0.8 mm, 1 mm, 3 mm, 10 mm, 20 mm, etc.). In some embodiments, two adjacent annular electrodes can be connected to the positive and negative terminals of an energy generator (not shown in the figure), respectively. Each annular electrode can be connected to the positive or negative terminal of the energy generator via a wire. In some embodiments, the wire can be enameled wire, which has electrical insulation properties and can withstand a voltage greater than or equal to 500V. The wire can run from inside the inner tube 11, or between the inner tube 11 and the outer tube 2, or it can be embedded in the inner tube wall. In some embodiments, such as Figures 1-5 As shown, four annular electrodes can be spaced apart on the outer side of the inner tube 11, namely: electrode 131, electrode 132, electrode 133, and electrode 134. In some embodiments, such as Figure 5 As shown, electrodes 131 and 33 can be connected to the positive terminal of the energy generator, and electrodes 232 and 434 can be connected to the negative terminal of the energy generator. Figure 5In the illustrated embodiment, the pulse field ablation catheter can be used to ablate the diseased tissue 61 in the tissue lumen 6 (e.g., a bronchus). During the ablation process, the elastic deformation body 12 can be expanded to abut the diseased tissue 61, and then the four ring electrodes can be energized to form a pulse field that covers the diseased tissue 61, thereby achieving ablation of the diseased tissue 61. In some embodiments, by arranging the ring electrodes, the pulse field formed between the electrodes can be more uniform, thereby achieving better ablation results. In some embodiments, some or all of the electrodes arranged outside the inner tube 11 can be non-ring electrodes. In some embodiments, only some of the electrode pieces can be arranged on one side of the inner tube 11, so that the pulse field formed between the electrode pieces can be used to ablate the diseased tissue on that side. In some embodiments, electrode pieces can be arranged on multiple sides (e.g., two sides, three sides) of the inner tube 11, so that the pulse field formed between the electrode pieces can be used to ablate the diseased tissue on multiple sides.

[0041] In some embodiments, the ring electrodes (e.g., the No. 1 electrode 131, the No. 2 electrode 132, the No. 3 electrode 133, and the No. 4 electrode 134, etc.) can be located inside the elastic deformation body 12. By arranging the ring electrodes inside the elastic deformation body 12, the relative positions of the diseased tissue and the ring electrodes can be observed using endoscopy, X-ray imaging, ultrasound imaging, etc., to more accurately ablate the diseased tissue. At the same time, by arranging the ring electrodes inside the elastic deformation body 12, when the elastic deformation body 12 is in an expanded state in the tissue lumen, the ring electrodes will be in the center of the tissue lumen. The centrally placed ring electrodes can allow the generated ablation electric field to be uniformly distributed in the center of the diseased tissue in the tissue lumen and uniformly cover the diseased tissue, thereby reducing the difficulty of the operation and reducing the requirement for the accuracy of the position arrangement when the physician operates. In some alternative embodiments, the ring electrodes can be partially or entirely arranged at both ends or outside the elastic deformation body 12.

[0042] In some embodiments, multiple annular electrodes (e.g., three or more) may be spaced apart on the outer side of the inner tube 11, and these annular electrodes may be spaced equally or unequally. In some embodiments, the spacing between the multiple annular electrodes may be greater than or equal to 0.3 mm (e.g., 0.3 mm, 0.5 mm, 0.8 mm, 1 mm, 2 mm, etc.). In some embodiments, all the annular electrodes on the outer side of the inner tube 11 may be energized simultaneously, thereby forming a pulsed electric field between each annular electrode for ablation of the lesion tissue covered by the pulsed electric field. In some embodiments, the multiple annular electrodes may be connected to the same positive or negative electrode of the energy generator, thereby easily achieving simultaneous energization of all annular electrodes. In some embodiments, any two adjacent annular electrodes on the outer side of the inner tube 11 may be energized, thereby forming a pulsed electric field only between (or within a certain range around) the energized annular electrodes for ablation of lesion tissue at a specific location. In some embodiments, the plurality of ring electrodes can be connected to different positive or negative terminals on the energy generator, thereby allowing any two adjacent ring electrodes on the outer side of the inner tube 11 to be energized by the energy generator. For example, each ring electrode can be connected to a different positive or negative terminal on the energy generator via a separate wire.

[0043] In some embodiments, at least one annular electrode (e.g., 1, 2, 3, 4, 5, 8, etc.) may be provided on the outer side of the inner tube 11. The annular electrode is located inside the elastic deformable body 12, which is made of a metallic material (e.g., spring steel, nickel-titanium alloy, etc.) and is conductive. In some embodiments, the annular electrode and the elastic deformable body 12 can be respectively connected to the positive and negative terminals of the energy generator. In some embodiments, such as Figure 6 As shown, the annular electrodes (such as electrode 131, electrode 132, electrode 133, and electrode 134) can be connected to the positive terminal of the energy generator, and the elastic deformable body 12 is connected to the negative terminal of the energy generator. In some embodiments, the annular electrodes can be connected to the negative terminal of the energy generator, and the elastic deformable body 12 can be connected to the positive terminal of the energy generator. In some embodiments, each annular electrode can be connected to the positive or negative terminal of the energy generator via a wire (such as enameled wire). The elastic deformable body 12 can be connected to the negative or positive terminal of the energy generator via a wire. In some embodiments, some or all of the wires can run from inside the inner tube 11, or from between the inner tube 11 and the outer tube 2, or can be embedded in the inner tube wall. By connecting the elastic deformable body 12 to one pole of the energy generator, a pulsed electric field can be formed between the elastic deformable body 12 and the annular electrode (or within a certain range around it), thereby achieving ablation of the lesion tissue. Figure 6In the illustrated embodiment, the pulsed field ablation catheter can be used to ablate lesion tissue 61 within a tissue lumen 6 (such as a bronchus). During ablation, the elastic deformable body 12 can expand and adhere to the lesion tissue 61. Then, energizing the four annular electrodes and the elastic deformable body 12 creates a pulsed field that covers the lesion tissue 61, thereby achieving ablation of the lesion tissue 61. In some embodiments, because the elastic deformable body 12 can expand and adhere to the inner wall of the tissue lumen or the lesion tissue, ablation can be performed by using the elastic deformable body 12 as an electrode. For example, using the elastic deformable body 12 as an electrode can ablate lesion tissue within a certain range (e.g., 10 mm, 15 mm, etc.) from the inner wall of the lumen (such as the tracheal wall), thus enabling ablation of lesion tissue farther from the inner wall of the lumen. In some embodiments, by attaching the elastic deformable body 12 as an electrode to the inner wall of the lumen (such as the tracheal wall), the pulse field ablation device can accurately detect the impedance of the tissue, thereby distinguishing different lesion tissues and performing targeted ablation (such as setting the corresponding pulse voltage according to the tolerance of the lesion tissue), thereby improving the ablation effect of the lesion tissue.

[0044] In some embodiments, at least two annular electrodes (e.g., 2, 3, 4, 5, 8, etc.) may be provided on the outer side of the inner tube 11. Each of these at least two annular electrodes is connected to one pole (e.g., positive or negative) of the energy generator; the elastic deformable body 12 is connected to the other pole (e.g., negative or positive) of the energy generator. In some embodiments, all the annular electrodes and elastic deformable bodies 12 on the outer side of the inner tube 11 can be energized simultaneously, thereby forming a pulsed electric field between each annular electrode and the elastic deformable body 12 for ablation of the lesion tissue covered by the pulsed electric field. In some embodiments, at least two annular electrodes can be connected to the same positive or negative pole of the energy generator, thus easily enabling simultaneous energization of all annular electrodes and elastic deformable bodies 12. In some embodiments, any annular electrode and elastic deformable body 12 on the outer side of the inner tube 11 can be energized, thereby forming a pulsed electric field only between (or within a certain range around) the energized annular electrode and elastic deformable body 12 for ablation of lesion tissue at a specific location. In some embodiments, at least two annular electrodes may be connected to different positive (or different negative) terminals on the energy generator, thereby enabling the energy generator to energize the elastic deformable body 12 and any one or more annular electrodes.

[0045] In some embodiments, such as Figure 7 As shown, the pulsed field ablation catheter may include an inner tube 11 and at least two elastic deformable bodies 12 (e.g., 2, 3, 4, etc.), with at least two elastic deformable bodies 12 spaced apart at the front end of the inner tube 11 along its length. Figure 7As shown, the at least two elastic deformable bodies 12 can include a first elastic deformable body 12a and a second elastic deformable body 12b. Both ends of the first elastic deformable body 12a and the second elastic deformable body 12b are fixedly connected to the inner tube 11. The first elastic deformable body 12a and the second elastic deformable body 12b can be in an expanded state in a natural state. The middle part of the first elastic deformable body 12a and the second elastic deformable body 12b can automatically expand when the outer tube 2 is extended and can automatically contract when the outer tube 2 is retracted. In some embodiments, at least two ring electrodes can be arranged at intervals on the outer side of the inner tube 11, and adjacent two ring electrodes are respectively connected to the positive and negative poles of the energy generator. As shown in the figure, Figure 7 As shown, the inner tube 11 can be arranged at intervals on the outer side of the inner tube 11. The 5th electrode 13c is connected to the positive pole of the energy generator, and the 6th electrode 13d is connected to the negative pole of the energy generator. In some embodiments, the pulse field region formed by the at least two ring electrodes can cover the interval region of the at least two elastic deformable bodies (such as the first elastic deformable body 12a and the second elastic deformable body 12b). When the lesion tissue is ablated by the pulse field ablation catheter, the lesion tissue can be placed in the interval region of the at least two elastic deformable bodies, so that the lesion tissue is ablated by the pulse electric field formed by the at least two ring electrodes. By arranging at least two elastic deformable bodies 12, the supporting and positioning effect of the elastic deformable body 12 can be better. By placing the lesion tissue in the interval region of the at least two elastic deformable bodies, the blocking of the elastic deformable body 12 can be avoided, so that the lesion tissue is closer to the ring electrode, thereby improving the ablation effect. In some embodiments, the at least two ring electrodes can be located inside the at least two elastic deformable bodies 12, so that the pulse field region formed by the at least two ring electrodes can cover the interval region of the at least two elastic deformable bodies 12. For example, as shown in the figure, Figure 7 As shown, the 5th electrode 13c can be located in the first elastic deformable body 12a, and the 6th electrode 13d can be located in the second elastic deformable body 13d. In the embodiment shown, Figure 7 As shown in the embodiment, the pulse field ablation catheter can be used to ablate the lesion tissue 61 in the tissue lumen 6 (such as a bronchus). During the ablation process, the first elastic deformable body 12a and the second elastic deformable body 12b can be expanded and respectively supported and positioned at both ends of the lesion tissue 61, and then the 5th electrode 13c and the 6th electrode 13d are powered to form a pulse field region 14, which can cover the lesion tissue 61 located between the first elastic deformable body 12a and the second elastic deformable body 12b, thereby realizing the ablation of the lesion tissue 61. In some alternative embodiments, the at least two elastic deformable bodies 12 can be respectively connected to one pole (such as the positive pole or the negative pole) of the energy generator, and the at least two elastic deformable bodies 12 can form a pulse electric field with the ring electrode inside to ablate the lesion tissue at the corresponding position.

[0046] Embodiments of the present application also relate to a pulsed field ablation device. In some embodiments, as shown in Figures 1-4 the pulsed field ablation device can include a pulsed field ablation catheter and a control handle 3. In some embodiments, the pulsed field ablation device can include the pulsed field ablation catheter as described in any of the embodiments of the present application. For example, the pulsed field ablation catheter can include an inner tube 11, an elastically deformable body 12 and an outer tube 2; the elastically deformable body 12 is arranged at the front end of the inner tube 11, at least one end of the elastically deformable body 12 is fixedly connected to the inner tube 11, the middle part of the elastically deformable body 12 is capable of expanding or contracting, the inner surface of the elastically deformable body 12 at least partially conforms to the inner tube 11 when the elastically deformable body 12 is contracted; the outer tube 2 is sleeved outside the inner tube 11, and the inner tube 11 is capable of moving relative to the outer tube 2. In some embodiments, the control handle 3 can be used to control the relative movement of the inner tube 11 and the outer tube 2 so as to control the expansion or contraction of the middle part of the elastically deformable body 12.

[0047] In some embodiments, the control handle 3 can include a housing and a control button 31, and the control button 31 is capable of sliding relative to the housing. In some embodiments, the housing of the control handle 3 can have a long strip structure, and the direction in which the control button 31 slides relative to the housing can be consistent with the length direction of the housing, thereby facilitating the operation of the control handle 3 to control the relative movement of the inner tube 11 and the outer tube 2. In some embodiments, one side of the housing can be provided with a sliding groove, and the control button 31 can be in sliding connection with the sliding groove, so that the control button 31 is capable of sliding relative to the housing. In some embodiments, one of the inner tube 11 or the outer tube 2 can be connected (such as glued, welded, clamped, etc.) to the control button 31, and the other one of the inner tube 11 or the outer tube 2 can be connected (such as glued, welded, clamped, etc.) to the housing; the sliding of the control button 31 relative to the housing can drive the relative movement of the inner tube 11 and the outer tube 2.

[0048] In some embodiments, as shown in Figures 1-2 the inner tube 11 (such as the rear end of the inner tube 11) can be connected to the control button 31, and the outer tube 2 (such as the rear end of the outer tube 2) can be connected to the housing; when the control button 31 slides relative to the housing, the inner tube 11 connected thereto is capable of moving relative to the outer tube 2, thereby causing the elastically deformable body 12 at the front end of the inner tube 11 to extend out of the outer tube 2 or retract into the outer tube 2. As shown in Figure 2As shown, the control button 31 and 31' can have two sliding states, corresponding to the state of the control button 31 sliding to the front end and the rear end, respectively. In some embodiments, when the control button 31 is slid from the rear end to the front end, the front end of the inner tube 11 can be moved out of the outer tube 2, and the elastic deformation body 12 provided at the front end of the inner tube 11 can be extended out of the outer tube 2 and expanded under the action of its own elastic force. In actual application scenarios, when the front end of the outer tube 2 extends into a specified position of the tissue lumen, medical personnel can control the elastic deformation body 12 to extend and expand to support positioning at the specified position by pushing the control button 31 to slide from the rear end to the front end. In some embodiments, when the control button 31 is slid from the front end to the rear end, the front end of the inner tube 11 can be moved into the outer tube 2, and the elastic deformation body 12 provided at the front end of the inner tube 11 can be retracted under the restriction of the inner wall of the outer tube 2 and move into the outer tube 2 along with the inner tube 11. In actual application scenarios, after the treatment of the patient is completed, medical personnel can control the elastic deformation body 12 to retract into the outer tube 2 by pushing the control button 31 to slide from the front end to the rear end, and then the pulse field ablation catheter (such as including the outer tube 2 and the inner tube 11) can be removed from the tissue lumen, so that the elastic deformation body 12 abutting against the inner wall of the tissue lumen can be prevented from causing damage to the inner wall of the tissue lumen during movement. In some alternative embodiments, the outer tube 2 (such as the rear end of the outer tube 2) can be connected with the control button 31, and the inner tube 11 (such as the rear end of the inner tube 11) can be connected with the housing, and when the control button 31 slides relative to the housing, the outer tube 2 connected therewith can move relative to the inner tube 11, so that the elastic deformation body 12 at the front end of the inner tube 11 can extend out of the outer tube 2 or retract into the outer tube 2.

[0049] In some embodiments, as shown in FIG. 1, the inner tube 11 (such as the rear end of the inner tube 11) can be connected with the control button 31, and the outer tube 2 (such as the rear end of the outer tube 2) can be connected with the housing, and when the control button 31 slides relative to the housing, the inner tube 11 connected therewith can move relative to the outer tube 2, so as to control the elastic deformation body 12 to expand or contract. Figures 3-4 In some embodiments, as shown in FIG. 1, the inner tube 11 (such as the rear end of the inner tube 11) can be connected with the control button 31, and the outer tube 2 (such as the rear end of the outer tube 2) can be connected with the housing, and when the control button 31 slides relative to the housing, the inner tube 11 connected therewith can move relative to the outer tube 2, so as to control the elastic deformation body 12 to expand or contract. Figures 3-4 In some embodiments, as shown in FIG. 1, the inner tube 11 (such as the rear end of the inner tube 11) can be connected with the control button 31, and the outer tube 2 (such as the rear end of the outer tube 2) can be connected with the housing, and when the control button 31 slides relative to the housing, the inner tube 11 connected therewith can move relative to the outer tube 2, so as to control the elastic deformation body 12 to expand or contract. Figure 4 In some embodiments, as shown in FIG. 1, the inner tube 11 (such as the rear end of the inner tube 11) can be connected with the control button 31, and the outer tube 2 (such as the rear end of the outer tube 2) can be connected with the housing, and when the control button 31 slides relative to the housing, the inner tube 11 connected therewith can move relative to the outer tube 2, so as to control the elastic deformation body 12 to expand or contract. Figure 3As shown), the distance between the two ends of the elastic deformable body 12 can be at its maximum. During the sliding of the control button 31 from the front end to the rear end, the distance between the two ends of the elastic deformable body 12 can gradually decrease from its maximum, causing the elastic deformable body 12 to be compressed, thus allowing the middle part of the elastic deformable body 12 to gradually expand. When the control button 31 is at the rear end, the elastic deformable body 12 can be in an expanded state (as shown). Figure 4 (As shown). In practical applications, as the inner tube 11 and outer tube 2 extend into the tissue lumen, the control button 31 can remain in the front position, at which point the elastic deformable body 12 remains contracted. When the front end of the inner tube 11 reaches the designated position in the tissue lumen, medical personnel can push the control button 31 to slide it from the front to the rear, thereby controlling the expansion of the elastic deformable body 12 to achieve support and positioning at the designated position. After the patient's treatment is completed, medical personnel can push the control button 31 to slide it from the rear to the front, controlling the contraction of the elastic deformable body 12, and then remove the pulse field ablation catheter (including the outer tube 2 and inner tube 11) from the tissue lumen, thus avoiding damage to the inner wall of the tissue lumen caused by the elastic deformable body 12 during movement. In some embodiments, medical personnel can push the control button 31 to stop at multiple or arbitrary positions on the slide, thereby adjusting the degree of expansion of the middle part of the elastic deformable body 12, making the pulse field ablation catheter suitable for different tissue lumens and / or lesions. In some embodiments, a limiting mechanism may be provided between the control button 31 and the slide. When the control button 31 stops at multiple or any position on the slide, the limiting mechanism can restrict the relative movement of the control button 31 and the slide, thereby avoiding unnecessary movement of the control button 31 during the ablation process. In some embodiments, the limiting mechanism may include, but is not limited to, a snap-fit ​​structure, a damping structure, a magnetic structure, or a combination of one or more of these. In some alternative embodiments, the outer tube 2 (e.g., the rear end of the outer tube 2) may be connected to the control button 31, and the inner tube 11 (e.g., the rear end of the inner tube 11) may be connected to the outer shell. When the control button 31 slides relative to the outer shell, the outer tube 2 connected to it may move relative to the inner tube 11, thereby controlling the expansion or contraction of the elastic deformable body 12.

[0050] In some embodiments, the pulsed field ablation device may include an energy generator. The energy generator can be used to apply high voltage to electrodes to form a pulsed field (or pulsed electric field). In some embodiments, electrodes (such as ring electrodes, elastic deformable bodies 12) can be connected to the positive or negative terminal of the energy generator via wires. In some embodiments, such as Figure 1As shown, the plurality of wires can be connected to the energy generator through the cable plug 4. In some embodiments, at least two ring electrodes can be arranged on the outer side of the inner tube 11, and the adjacent two ring electrodes are connected to the positive and negative poles of the energy generator, respectively. In some embodiments, at least three ring electrodes can be arranged on the outer side of the inner tube 11, and the energy generator can control the formation of a pulse field between any two adjacent ring electrodes. For example, the energy generator can control the energization of any two adjacent ring electrodes. For another example, the energy generator can control the simultaneous energization of all ring electrodes. By energizing any two adjacent ring electrodes on the outer side of the inner tube 11, a pulse electric field can be formed only between (or within a certain range around) the energized ring electrodes, so as to perform targeted ablation on the diseased tissue at a specific position. In some embodiments, at least one ring electrode can be arranged on the outer side of the inner tube, and the at least one ring electrode is located inside the elastic deformer 12; the elastic deformer is made of a metal material. In some embodiments, the at least one ring electrode is connected to the positive pole of the energy generator, and the elastic deformer 12 is connected to the negative pole of the energy generator; or the at least one ring electrode is connected to the negative pole of the energy generator, and the elastic deformer 12 is connected to the positive pole of the energy generator. By connecting the ring electrode and the elastic deformer 12 to the positive and negative poles of the energy generator, respectively, the energy generator can control the formation of a pulse electric field between the ring electrode and the elastic deformer 12, so as to perform ablation on the diseased tissue at a corresponding position. In some embodiments, at least two ring electrodes can be arranged on the outer side of the inner tube 11, and the energy generator can control the formation of a pulse field between any ring electrode and the elastic deformer 12. For example, the energy generator can control the energization of any ring electrode and the elastic deformer 12. For another example, the energy generator can control the simultaneous energization of all ring electrodes and the elastic deformer 12. By energizing any ring electrode on the outer side of the inner tube 11 and the elastic deformer 12, a pulse electric field can be formed only between (or within a certain range around) the energized ring electrode and the elastic deformer 12, so as to perform targeted ablation on the diseased tissue at a specific position; and the ablation site can be flexibly adjusted without moving the pulse field ablation catheter.

[0051] Figure 8 is a schematic view of a control handle structure comprising a bending control mechanism according to some embodiments of the present application; Figure 9 is a schematic view of a left rotation structure of the bending control mechanism according to some embodiments of the present application; Figure 10 is a schematic view of a right rotation structure of the bending control mechanism according to some embodiments of the present application. In some embodiments, as shown in Figures 8-10 , the control handle 3 can comprise a bending control mechanism, which can be used to control the bending of the front part of the outer tube 2. In some embodiments, as shown in Figures 8-10As shown, the bending control mechanism may include a bending control knob 7. When the bending control knob 7 is rotated to different states, the front part of the outer tube 2 can be bent in different directions. For example, as Figure 8 As shown, when the bending control knob 7 is rotated to the left rotation state 7a, the front part of the outer tube 2 can bend to the left to achieve the outer tube left bending state 2a, and the inner tube 11 can bend along with the outer tube 2 to achieve the inner tube left bending state 11a. For example, as... Figure 9 As shown, when the bending control knob 7 is rotated to the right rotation state 7b, the front part of the outer tube 2 can bend to the right to achieve the outer tube right bend state 2b, and the inner tube 11 can bend along with the outer tube 2 to achieve the inner tube right bend state 11b. In some embodiments, the bending control knob 7 can control the bending of the front part of the outer tube 2 via traction ropes. For example, the bending control knob 7 can be connected to one end of two traction ropes, and the other ends of the two traction ropes can be connected to the left and right sides of the front end of the outer tube 2 respectively. When the bending control knob 7 is rotated to the left or right, the bending control knob 7 can pull different traction ropes respectively, thereby controlling the front part of the outer tube 2 to bend to the left or right. In some embodiments, the structure of the front part of the outer tube 2 is different from the structure of other parts of the outer tube, making the front part of the outer tube 2 easier to bend under force compared to other parts of the outer tube 2. In some embodiments, the bending control mechanism can include other structures that can control the bending of the front part of the outer tube 2. For example, the bending control mechanism can include a push-pull structure, a button structure, a rocker arm structure, etc. By setting a bending control mechanism to control the bending of the front part of the outer tube 2, it is possible to facilitate the delivery of the pulse field ablation catheter (such as the outer tube 2 and / or the inner tube 11) into the tissue lumen.

[0052] In some embodiments, the outer tube 2 may include one or more channels, and the inner tube 11 may pass through one of these channels and move relative to the outer tube 2. In some embodiments, such as Figures 5-7 As shown, the pulsed field ablation catheter can be used to ablate lesions 6 inside tissue cavities 6 (such as bronchioles). Figures 5-7 In the illustrated embodiment, the outer tube 2 can be a bronchoscope 5 (such as a fiberoptic bronchoscope), which may include three channels, through which the inner tube 11 can pass. In some embodiments, the pulsed field ablation device may also include an endoscope, and the outer tube 2 may have a channel for the endoscope to pass through (such as one of the channels of the bronchoscope 5). The endoscope facilitates observation of the pulsed field ablation catheter's status in the tissue lumen and the ablation of the lesion. In some embodiments, other channels of the outer tube 2 can be used for other instruments (such as biopsy needles).

[0053] The pulse field ablation catheter and the device disclosed in the present application can bring benefits including but not limited to: (1) can be applied to various lesion tissues in different parts for pulse field ablation; (2) can conveniently position the ablation electrode at a specified position; (3) can perform targeted ablation on lesion tissues in different positions without moving the pulse field ablation catheter; (4) can ablate lesion tissues far from the inner wall of the tissue lumen; (5) can reduce damage to the inner wall of the tissue lumen during ablation; (6) simple operation and strong practicability. It should be noted that different embodiments can have different benefits, and in different embodiments, the benefits can be any one or a combination of the above, or any other possible benefit.

[0054] The embodiments of the present application also relate to a pulse field ablation control method and system. The pulse field ablation control system can be used to control the pulse field ablation device, so that the pulse field ablation device can adopt a targeted pulse field ablation scheme according to different lesion tissues, thereby better achieving ablation of the lesion tissues.

[0055] Figure 11 is an exemplary flowchart of the pulse field ablation control method according to some embodiments of the present application. The pulse field ablation control method 1100 can be performed by the pulse field ablation control system 1200. As shown in Figure 11 The pulse field ablation control method 1100 can include the following steps:

[0056] Step 1110, determining the impedance characteristics of the ablation site. In some embodiments, step 1110 can be performed by the pulse field ablation control system 1200 (such as the impedance characteristic determination module 1210).

[0057] In some embodiments, the ablation site can be a region ready for pulse field ablation. In some embodiments, the ablation site can include at least part of the lesion tissue. In some embodiments, the ablation site can be selected and determined by medical personnel. For example, medical personnel can use an endoscope, X-ray imaging, ultrasonic imaging, etc. to check the tissue lumen, so as to determine the ablation site.

[0058] In some embodiments, the impedance characteristic of the site to be ablated can include one or more impedance values of the site to be ablated. In some embodiments, the impedance characteristic determination module 1210 can apply a voltage to at least two electrodes at the site to be ablated and detect a current flowing through the at least two electrodes; according to the voltage and the current, the impedance characteristic determination module 1210 can determine an impedance value of the site to be ablated. Specifically, the impedance characteristic determination module 1210 can control the energy generator to apply a voltage to at least two electrodes at the site to be ablated and detect a current flowing through the at least two electrodes. In some embodiments, the at least two electrodes at the site to be ablated can be electrodes whose regions of the formed pulsed electric field overlap with the site to be ablated. In some embodiments, the at least two electrodes at the site to be ablated can be electrodes whose regions of the formed pulsed electric field can cover the site to be ablated.

[0059] In some embodiments, the electrodes can be disposed outside the inner tube 11 (e.g., the first electrode 131, the second electrode 132, the third electrode 133, and the fourth electrode 134). In some embodiments, when there are two electrodes (e.g., two adjacent electrodes) at the site to be ablated, the impedance characteristic determination module 1210 can apply a voltage to the two electrodes and detect a current flowing through the two electrodes, thereby determining an impedance value of the site to be ablated. In some embodiments, when there are multiple electrodes (e.g., three electrodes, four electrodes) at the site to be ablated, the site to be ablated can be divided into two or more sub-sites, and the impedance value of the site to be ablated can include sub-impedance values of the two or more sub-sites. Each sub-site is the site to be ablated between two adjacent electrodes. The impedance characteristic determination module 1210 can apply a voltage to any two adjacent electrodes of the multiple electrodes and detect a current flowing through the two adjacent electrodes, thereby determining an impedance value of a corresponding sub-site of the site to be ablated.

[0060] In some embodiments, the elastic deformable body 12 can serve as one of the electrodes, and at least one annular electrode can be provided on the outer side of the inner tube 11, with the at least one annular electrode located inside the elastic deformable body 12. In some embodiments, when the elastic deformable body 12 is in an expanded state, the impedance characteristic determination module 1210 can apply a voltage to the elastic deformable body 12 and at least one annular electrode at the ablation site, and detect the current flowing through the elastic deformable body 12 and at least one annular electrode, thereby determining the impedance value of the ablation site. In some embodiments, when two or more annular electrodes are at the ablation site, the ablation site can be divided into two or more sub-sites, and the impedance value of the ablation site can include the sub-impedance values ​​of the two or more sub-sites. Each sub-site can be the ablation site that can be covered by the pulsed electric field formed between each annular electrode and the elastic deformable body 12. The impedance characteristic determination module 1210 can apply a voltage to any annular electrode and the elastic deformable body 12, and detect the current flowing through the annular electrode and the elastic deformable body 12, thereby determining the impedance value of the corresponding sub-site of the ablation site.

[0061] In some embodiments, the impedance characteristic determination module 1210 can acquire multiple impedance values ​​of the ablation site corresponding to multiple states of the elastic deformable body 12. In some embodiments, the state of the elastic deformable body 12 can reflect the degree of expansion of the elastic deformable body 12. In some embodiments, the degree of expansion of the elastic deformable body 12 can be adjusted. When the degree of expansion of the elastic deformable body 12 is different, the contact area and / or contact force between the elastic deformable body 12 and the lesion tissue or the inner wall of the lumen is different, thereby resulting in different impedance values ​​measured at the ablation site. In some embodiments, the degree of expansion of the elastic deformable body 12 can be adjusted by the distance between the two ends of the elastic deformable body 12. For example, as... Figures 3-4 As shown, the greater the distance between the two ends of the elastic deformable body 12, the smaller its expansion degree; the smaller the distance between the two ends of the elastic deformable body 12, the greater its expansion degree. In some embodiments, medical personnel can control the distance between the two ends of the elastic deformable body 12 by controlling the control button 31 on the control handle 3, thereby controlling the expansion degree of the elastic deformable body 12. In some embodiments, the impedance characteristic determination module 1210 can acquire the state of the elastic deformable body 12 (such as the distance between its two ends). For example, the impedance characteristic determination module 1210 can acquire the position information of the control button 31 on the control handle 3 by a sensor (such as a displacement sensor), and determine the distance between the two ends of the elastic deformable body 12 based on the position information of the control button 31. In some embodiments, when the medical personnel push the control button 31 to move so that the state of the elastic deformable body 12 changes, the impedance characteristic determination module 1210 can acquire the state of the elastic deformable body 12 and the impedance value of the ablation site in this state at certain intervals (such as 0.2s, 0.5s, 1s, etc.).

[0062] In some embodiments, the impedance characteristic determination module 1210 can determine the impedance characteristic of the site to be ablated according to the impedance value of the site to be ablated. In some embodiments, the impedance characteristic determination module 1210 can take one or more impedance values of the site to be ablated as the impedance characteristic of the site to be ablated. In some embodiments, the impedance characteristic determination module 1210 can determine the impedance characteristic of the site to be ablated according to a plurality of states of the elastic deformation body 12 and a plurality of impedance values of the site to be ablated corresponding to the plurality of states. In this case, the impedance characteristic can be represented as a mapping relationship between the plurality of states of the elastic deformation body 12 and the plurality of impedance values of the site to be ablated. In some embodiments, the impedance characteristic of the site to be ablated can include an impedance value change curve. In some embodiments, the impedance value change curve can reflect the change of the impedance value of the site to be ablated with respect to the state of the elastic deformation body 12. For example, the impedance value change curve can reflect the change of the impedance value of the site to be ablated with respect to the distance between the two ends of the elastic deformation body 12.

[0063] In some embodiments, the impedance characteristic determination module 1210 can detect the impedance value of the site to be ablated in other ways. In some embodiments, the impedance characteristic determination module 1210 can detect the impedance value of the site to be ablated by applying a current to the electrode at the site to be ablated. For example, the impedance characteristic determination module 1210 can apply an alternating current with constant amplitude to a pair of electrodes at the site to be ablated, and detect the voltage across the pair of electrodes; thereby determining the impedance value of the site to be ablated according to the alternating current with constant amplitude and the detected voltage.

[0064] At step 1120, the characteristic of the lesion tissue is determined according to the impedance characteristic of the site to be ablated. In some embodiments, step 1120 can be performed by the pulse field ablation control system 1200 (e.g., the lesion tissue characteristic determination module 1220).

[0065] In some embodiments, the characteristic of the lesion tissue can include any combination of one or more of the type, shape, volume, and mass of the lesion tissue, etc. In some embodiments, the type of the lesion tissue can include, but is not limited to, bronchitis, emphysema, bronchial gland hyperplasia, atrial fibrillation, local hyperplastic tumor, etc. In some embodiments, the type of the lesion tissue can also include classification information of cells, bacteria, fungi, viruses, etc. in the lesion tissue. For example, bronchitis can include bacterial bronchitis, fungal bronchitis, viral bronchitis, etc. In some embodiments, the shape of the lesion tissue can include, but is not limited to, regular shape (e.g., spherical, ellipsoidal, etc.) or irregular shape.

[0066] In some embodiments, the lesion tissue characteristic determination module 1220 can determine the characteristic of the lesion tissue according to the impedance value of the site to be ablated and the correspondence between the impedance value and the characteristic of the lesion tissue. In some embodiments, the correspondence between the impedance value and the characteristic of the lesion tissue can be determined according to clinical experience and / or experiment, etc. In some embodiments, the pulse field ablation control system 1200 can include a database established according to the correspondence between the impedance value and the characteristic of the lesion tissue. When the impedance characteristic of the site to be ablated is an impedance value, the lesion tissue characteristic determination module 1220 can search the database according to the impedance value to obtain the corresponding characteristic of the lesion tissue. In some embodiments, the impedance characteristic of the site to be ablated can include only one impedance value. In this case, the lesion tissue characteristic determination module 1220 can determine the characteristic of the lesion tissue according to the impedance value and the correspondence between the impedance value and the characteristic of the lesion tissue. In some embodiments, the impedance characteristic of the site to be ablated can include two or more impedance values. For example, the impedance characteristic of the site to be ablated can include a plurality of impedance values corresponding to the site to be ablated in a plurality of states of the elastic deformation body. In this case, the lesion tissue characteristic determination module 1220 can determine the characteristic of the lesion tissue according to the average of the plurality of impedance values and the correspondence between the impedance value and the characteristic of the lesion tissue. By determining the characteristic of the lesion tissue based on the impedance value and the correspondence between the impedance value and the characteristic of the lesion tissue, the determination process can be simple, efficient and accurate.

[0067] In some embodiments, the pulse field ablation control system 1200 can establish a plurality of sub-databases according to different parts of the human body (such as bronchus, intestinal tract, gallbladder, etc.), and each sub-database includes the correspondence between the impedance value and the characteristic of the lesion tissue at the part. The lesion tissue characteristic determination module 1220 can search the impedance value in the corresponding sub-database according to the position of the site to be ablated in the human body to determine the characteristic of the lesion tissue. In some embodiments, the lesion tissue characteristic determination module 1220 can determine the position of the site to be ablated in the human body according to the information input by the user. For example, the user (such as medical personnel) can input the position of the site to be ablated in the human body through an input device (such as a mouse, a keyboard, etc.). By establishing different sub-databases for different parts of the human body, the accuracy of the determination of the characteristic of the lesion tissue can be improved. In some embodiments, when the site to be ablated is divided into two or more sub-sites, the lesion tissue characteristic determination module 1220 can determine the characteristic of the lesion tissue of each sub-site according to the impedance value of each sub-site and the correspondence between the impedance value and the characteristic of the lesion tissue.

[0068] In some embodiments, the lesion tissue feature determination module 1220 can determine the feature of the lesion tissue according to the impedance value change curve of the ablation site to be ablated, by using the trained lesion tissue feature determination model. In some embodiments, the lesion tissue feature determination model can be a machine learning model. The lesion tissue feature determination model can include, but is not limited to, one or any combination of a convolutional neural network model (CNN), a recurrent neural network model (RNN), a RCNN model (Regions with CNN), a Fast-RCNN model, a BP neural network model, a K nearest neighbor algorithm model (KNN), a support vector machine model (SVM), etc. In some embodiments, the lesion tissue feature determination module 1220 can determine one or more lesion tissue features of the ablation site to be ablated by using the trained lesion tissue feature determination model. By determining the feature of the lesion tissue based on the impedance value change curve of the ablation site to be ablated, using the lesion tissue feature determination model, the accuracy of the determination can be effectively improved. For more details of the lesion tissue feature determination model, please refer to Figure 13 and the related description.

[0069] In some embodiments, the pulse field ablation control system 1200 can obtain a plurality of lesion tissue feature determination sub-models by training according to different parts of the human body (such as bronchus, intestinal tract, gallbladder, etc.). The lesion tissue feature determination module 1220 can determine the feature of the lesion tissue according to the position of the ablation site to be ablated in the human body, by using the corresponding lesion tissue feature determination sub-model. In some embodiments, the lesion tissue feature determination module 1220 can determine the position of the ablation site to be ablated in the human body according to the information input by the user. For example, the user (such as medical personnel) can input the position of the ablation site to be ablated in the human body through an input device (such as a mouse, a keyboard, etc.). By using different lesion tissue feature determination sub-models for different parts of the human body, the accuracy of the lesion tissue feature determination can be improved. In some embodiments, when the ablation site to be ablated is divided into two or more sub-sites, the lesion tissue feature determination module 1220 can determine the feature of the lesion tissue according to the impedance value change curve of each sub-site, respectively, by using the trained lesion tissue feature determination model.

[0070] In some embodiments, the pulsed field ablation control system 1200 can determine the characteristics of the lesion tissue in other manners. In some embodiments, the pulsed field ablation control system 1200 can obtain the identification information of the characteristics of the lesion tissue input by a user (e.g., medical staff). For example, the user can identify the characteristics of the lesion tissue at the ablation site based on endoscopic images, X-ray images, ultrasonic images, etc. according to experience, and input the result to the pulsed field ablation control system 1200. In some embodiments, the user can input the determination result of the characteristics of the lesion tissue by operating a terminal / human-computer interaction interface. Specifically, the user input methods can include but are not limited to voice input, text input, mouse selection input, touch screen input, etc.

[0071] In some embodiments, the lesion tissue characteristic determination module 1220 can first determine the characteristics of the lesion tissue by using the trained lesion tissue characteristic determination model, and then send the information of the characteristics of the lesion tissue to the user for confirmation (e.g., show or broadcast the information of the characteristics of the lesion tissue to the user). The user can confirm or re-input / select the information of the characteristics of the lesion tissue, so as to determine the final characteristics of the lesion tissue. By combining model recognition with manual judgment, the recognition efficiency and accuracy can be improved. In some embodiments, based on the user's confirmation of the information, the system failure or the situation that the lesion tissue characteristic determination model cannot identify the characteristics of the lesion tissue can be prevented. In some embodiments, when the lesion tissue characteristic determination module 1220 determines the characteristics of the lesion tissue, but the user does not recognize the result, the user can feed back to the pulsed field ablation control system 1200 and make the system perform secondary processing. In the secondary processing, the lesion tissue characteristic determination module 1220 can determine the characteristics of the lesion tissue again in combination with the identification information of the characteristics of the lesion tissue input by the user.

[0072] At step 1130, the pulsed field ablation parameters are determined based on the characteristics of the lesion tissue. In some embodiments, step 1130 can be performed by the pulsed field ablation control system 1200 (e.g., the ablation parameter determination module 1230).

[0073] In some embodiments, the pulsed field ablation parameters can include but are not limited to one or more combinations of ablation time, pulse voltage, pulse width, and pulse frequency, etc. The ablation time can include the ablation start time, the ablation end time, and / or the ablation duration. The pulse voltage can be the voltage applied to the electrode. The pulse width can be the time duration of the high level. The pulse frequency can be the number of pulses per unit time (e.g., 1 s). In some embodiments, when the elastically deformable body is used as the electrode, the pulsed field ablation parameters can further include the state of the elastically deformable body (e.g., the degree of expansion).

[0074] In some embodiments, the ablation parameter determination module 1230 can determine the pulsed field ablation parameters based on the characteristics of the lesion tissue and according to a correspondence between the characteristics of the lesion tissue and the pulsed field ablation parameters. In some embodiments, the correspondence between the characteristics of the lesion tissue and the pulsed field ablation parameters can be determined according to clinical experience and / or experiments. In some embodiments, a database established according to the correspondence between the characteristics of the lesion tissue and the pulsed field ablation parameters can be included in the pulsed field ablation control system 1200. The ablation parameter determination module 1230 can retrieve the corresponding pulsed field ablation parameters from the database based on the characteristics of the lesion tissue. By determining the pulsed field ablation parameters based on the correspondence between the characteristics of the lesion tissue and the pulsed field ablation parameters, the process of determining the ablation parameters can be facilitated, efficient and accurate. In some embodiments, the ablation parameter determination module 1230 can determine the state of the elastic deformation body in the pulsed field ablation parameters based on the characteristics of the lesion tissue and the correspondence between the characteristics of the lesion tissue and the pulsed field ablation parameters, so that a more optimal state of the elastic deformation body is adopted in the ablation process, thereby improving the ablation effect.

[0075] In some embodiments, the ablation parameter determination module 1230 can determine the pulsed field ablation parameters based on the characteristics of the lesion tissue by using a trained ablation parameter determination model. In some embodiments, the ablation parameter determination model can be a machine learning model. The ablation parameter determination model can include, but is not limited to, one or any combination of a convolutional neural network model (CNN), a recurrent neural network model (RNN), a RCNN model (regions with CNN), a Fast-RCNN model, a BP neural network model, a K-nearest neighbor algorithm model (KNN), a support vector machine model (SVM), etc. In some embodiments, the ablation parameter determination module 1230 can determine one or more ablation parameters by using the trained ablation parameter determination model. By determining the pulsed field ablation parameters based on the characteristics of the lesion tissue by using the trained ablation parameter determination model, the accuracy of determining the ablation parameters can be effectively improved. For more details of the ablation parameter determination model, please refer to Figure 14 and the related description.

[0076] In some embodiments, when the ablation site to be ablated is divided into two or more sub-sites, the ablation parameter determination module 1230 can determine the pulsed field ablation parameters according to the characteristics of the lesion tissue of each sub-site, respectively. In some embodiments, when the characteristics of the lesion tissue of each sub-site are different, the ablation parameter determination module 1230 can determine different pulsed field ablation parameters for each sub-site, so that the lesion tissue of each sub-site can be more effectively and accurately ablated.

[0077] In some embodiments, the pulsed field ablation control system 1200 can determine the pulsed field ablation parameters in other manners. In some embodiments, the pulsed field ablation control system 1200 can obtain the determination of the pulsed field ablation parameters input by a user (e.g., medical staff). For example, the user can determine the ablation parameters according to artificial judgment and input the ablation parameters through the terminal / human-computer interaction interface. Specifically, the user input methods can include, but are not limited to, voice input, text input, mouse selection input, touch screen input, etc.

[0078] In some embodiments, the ablation parameter determination module 1230 can first determine the ablation parameters by using the trained ablation parameter determination model, and then send the ablation parameter information to the user for confirmation (e.g., display or broadcast the ablation parameter information to the user). The user can confirm or re-input / choose the ablation parameter information, so as to determine the final pulsed field ablation parameters. By combining model recognition with artificial judgment, the ablation parameter determination efficiency and accuracy can be improved. In some embodiments, based on the user's confirmation of the information, the system failure or the situation that the ablation parameter determination model cannot obtain the ablation parameters can be prevented. In some embodiments, when the ablation parameter determination module 1230 determines the ablation parameters, but the user does not confirm the result, the user can feed back to the pulsed field ablation control system 1200 and make the system perform secondary processing or manually input the ablation parameters.

[0079] At step 1140, ablation is performed on the lesion tissue based on the pulsed field ablation parameters. In some embodiments, step 1140 can be performed by the pulsed field ablation control system 1200 (e.g., the ablation module 1240).

[0080] In some embodiments, the ablation module 1240 can control the energy generator to energize at least two electrodes at the ablation site based on the pulsed field ablation parameters (e.g., ablation time, pulse voltage, pulse width, and pulse frequency, etc.), so as to ablate the lesion tissue at the ablation site. In some embodiments, when the ablation site is divided into two or more sub-sites, the ablation module 1240 can energize the electrodes corresponding to each sub-site according to the pulsed field ablation parameters of each sub-site, so as to ablate the lesion tissue of each sub-site. In some embodiments, when the pulsed field ablation parameters include the state of the elastic deformation body, the ablation module 1240 can prompt the user (e.g., medical staff) to control the elastic deformation body to reach the specified state. In some embodiments, the state of the elastic deformation body during the ablation process can be the expanded state of the elastic deformation body.

[0081] It should be noted that the above description of the pulse field ablation control method 1100 is merely for example and illustration, and does not limit the scope of the application. Those skilled in the art can make various modifications and changes to the pulse field ablation control method 1100 under the guidance of the application. However, these modifications and changes are still within the scope of the application. For example, the determination of the impedance characteristic of the ablation site in step 1110 can be omitted, and the user's identification information of the lesion tissue feature can be directly obtained. For another example, the determination of the lesion tissue feature in step 1120 can be omitted, and the relationship between the impedance characteristic and the ablation parameter can be directly established.

[0082] Figure 12 is a module diagram of a pulse field ablation control system according to some embodiments of the application. As shown in Figure 12 the pulse field ablation control system 1200 can include an impedance characteristic determination module 1210, a lesion tissue feature determination module 1220, an ablation parameter determination module 1230, and an ablation module 1240.

[0083] The impedance characteristic determination module 1210 can be configured to determine the impedance characteristic of the ablation site. In some embodiments, the impedance characteristic determination module 1210 can obtain an impedance value of the ablation site, thereby determining the impedance characteristic of the ablation site. In some embodiments, the impedance characteristic determination module 1210 can obtain a plurality of impedance values of the ablation site, establish an impedance value change curve, thereby determining the impedance characteristic of the ablation site.

[0084] The lesion tissue feature determination module 1220 can be configured to determine the feature of the lesion tissue according to the impedance characteristic of the ablation site. In some embodiments, the lesion tissue feature determination module 1220 can determine the feature of the lesion tissue according to the impedance value of the ablation site and the corresponding relationship between the impedance value and the feature of the lesion tissue. In some embodiments, the lesion tissue feature determination module 1220 can determine the feature of the lesion tissue by using a trained lesion tissue feature determination model according to the impedance value change curve of the ablation site.

[0085] The ablation parameter determination module 1230 can be configured to determine the pulse field ablation parameter based on the feature of the lesion tissue. In some embodiments, the ablation parameter determination module 1230 can determine the pulse field ablation parameter based on the feature of the lesion tissue and according to the corresponding relationship between the feature of the lesion tissue and the pulse field ablation parameter. In some embodiments, the ablation parameter determination module 1220 can determine the pulse field ablation parameter by using a trained ablation parameter determination model based on the feature of the lesion tissue.

[0086] The ablation module 1240 can be configured to ablate the lesion tissue. In some embodiments, the ablation module 1240 can be configured to ablate the lesion tissue based on the pulse field ablation parameter.

[0087] In some embodiments, the pulse field ablation control system 1200 can further include other execution modules. For example, the pulse field ablation control system 1200 can further include any combination of one or more of a data processing module, an information display module, an information prompting module, a model training module, and the like.

[0088] In some embodiments, the pulse field ablation control system 1200 can include a computing device, which can include at least one processor that can be used to implement the various modules described above. In some embodiments, the computing device can be a single server or a group of servers. The group of servers can be centralized or distributed. In some embodiments, the computing device can be local or remote. In some embodiments, the computing device can also be implemented on a cloud platform.

[0089] In some embodiments, the pulse field ablation control system 1200 can further include a combination of one or more of an input device, an output device, a network, a terminal, a storage medium, and the like. In some embodiments, the network can include any suitable network capable of facilitating the exchange of information and / or data of the pulse field ablation control system 1200. For example, the network can include a public network (such as the Internet), a private network (such as a local area network (LAN), a wide area network (WAN), and the like), a wired network (such as an Ethernet network), a wireless network (such as an 802.11 network, a WiFi network, and the like), a cellular network, a frame relay network, a virtual private network (VPN), a satellite network, a telephone network (including voice over

[0090] In some embodiments, the pulsed field ablation control system 1200 can have signal connection (e.g., through network connection) with the pulsed field ablation device, so that the pulsed field ablation control system 1200 can control components of the pulsed field ablation device or acquire information of the components. For example, the pulsed field ablation control system 1200 can control the pulsed field energy generator to energize the electrodes so as to ablate the lesion tissue. For another example, the pulsed field ablation control system 1200 can acquire position information of the control button 31 on the control handle 3. In some embodiments, the pulsed field ablation control system 1200 can be integrated in the pulsed field ablation device in whole or in part. For example, the pulsed field ablation device can include a storage medium and a processor, the storage medium stores computer instructions, and the processor can execute the pulsed field ablation control method described in any of the embodiments of the present application after reading the computer instructions in the storage medium.

[0091] It should be noted that the above description of the pulsed field ablation control system and its modules is for the convenience of description, and cannot limit the present application to the scope of the embodiments. It can be understood that, for those skilled in the art, after understanding the principle of the system, any combination of the modules or connection of the modules with other modules can be made without departing from the principle. For example, in some embodiments, Figure 12 The impedance characteristic determination module 1210, the lesion tissue characteristic determination module 1220, the ablation parameter determination module 1230 and the ablation module 1240 disclosed in the above embodiments can be different modules in a system, or one module can implement the functions of two or more modules. For example, the lesion tissue characteristic determination module 1220 and the ablation parameter determination module 1230 can be two modules, or one module can have the functions of determining the lesion tissue characteristic and determining the ablation parameter. For another example, each module can share one storage module, or each module can have its own storage module. Such variations are within the scope of the present application.

[0092] Figure 13 is an exemplary flowchart of a lesion tissue characteristic determination model training method according to some embodiments of the present application. The lesion tissue characteristic determination model training method 1300 can be executed by the pulsed field ablation control system 1200. As shown in Figure 13 , the training method 1300 can include:

[0093] Step 1310, acquiring an impedance value change curve sample.

[0094] In some embodiments, the impedance value change curve sample can include an impedance value change curve of the site to be ablated in a historical ablation process. In some embodiments, the impedance value change curve sample can reflect a change of the impedance value of the site to be ablated relative to the state of the elastic deformation body 12 in the historical ablation process. For example, the impedance value change curve sample can reflect a change of the impedance value of the site to be ablated relative to the distance between the two ends of the elastic deformation body 12 in the historical ablation process. In some embodiments, the impedance value change curve of the site to be ablated obtained in the historical ablation process can be stored in a storage medium (such as a database), and the pulse field ablation control system 1200 can obtain the impedance value change curve sample from the database. In some embodiments, the impedance value change curve sample can be obtained in other ways. For example, the impedance value change curve sample can include a test sample, a simulation sample, etc.

[0095] In step 1320, the lesion tissue feature corresponding to the impedance value change curve sample is obtained.

[0096] In some embodiments, the lesion tissue feature corresponding to the impedance value change curve sample can be obtained by a user (such as medical staff) labeling. Specifically, the user can comprehensively identify the feature of the lesion tissue based on the information corresponding to the impedance value change curve sample (such as the image of the lesion tissue in the site to be ablated, the position where the lesion tissue is located, the detection result of the lesion tissue, the patient information, etc.). In some embodiments, the user can label the lesion tissue feature corresponding to the impedance value change curve sample by operating the terminal / human-computer interaction interface. Specifically, the user can input the lesion tissue feature identification information through the human-computer interaction interface. The way in which the user inputs the lesion tissue feature identification information can include but is not limited to voice input, text input, mouse selection input, touch screen input, etc. For example, after the user selects a certain impedance value change curve sample, the system can display the information corresponding to the sample and pop up a lesion tissue feature list, and the user can select the lesion tissue feature corresponding to the curve according to the judgment. In some embodiments, the impedance value change curve sample and the corresponding lesion tissue feature can be stored in a database, and the pulse field ablation control system 1200 can obtain the lesion tissue feature corresponding to the impedance value change curve sample from the database.

[0097] After performing steps 1310 and 1320, the pulse field ablation control system 1200 can obtain a plurality of sample pairs, each sample pair including an impedance value change curve sample and a corresponding lesion tissue feature. In some embodiments, as shown in FIG. 13B, the pulse field ablation control system 1200 can obtain a plurality of sample pairs by performing steps 1310 and 1320 a plurality of times. Figure 13As shown, the pulse field ablation control system 1200 can divide the plurality of sample pairs into a model training set 1301 and a model testing set 1302. The model training set 1301 can be used to train the lesion tissue feature determination model; the model testing set 1302 can be used to test the lesion tissue feature determination model obtained by training. In some embodiments, the pulse field ablation control system 1200 can randomly divide the plurality of sample pairs in a certain ratio. For example, the ratio of the training set and the testing set can be 8 to 2, 9 to 1, 9.5 to 0.5, etc.

[0098] Step 1330, inputting the model training set into the initial lesion tissue feature determination model for training to obtain the lesion tissue feature determination model.

[0099] In some embodiments, the initial lesion tissue feature determination model can include, but is not limited to, one of a convolutional neural network model (CNN), a recurrent neural network model (RNN), a RCNN model (regions with CNN), a Fast-RCNN model, a BP neural network model, a K nearest neighbor algorithm model (KNN), a support vector machine model (SVM), etc. or any combination thereof. In a specific embodiment, the initial lesion tissue feature determination model can be constructed based on a convolutional neural network (CNN) model. The CNN model can include one input node and multiple output nodes. In the training process, the input of the input node is the impedance value change curve sample in the model training set 1301, and the output of the output node is the type, volume and mass of the lesion tissue. By inputting the sample pairs in the model training set 1301 into the initial lesion tissue feature determination model, a trained lesion tissue feature determination model can be obtained.

[0100] Step 1340, testing the lesion tissue feature determination model.

[0101] In this step, the pulse field ablation control system 1200 can input the sample pair data in the model testing set 1302 into the trained lesion tissue feature determination model obtained in step 1330 for testing to obtain the output result. The pulse field ablation control system 1200 can further compare whether the output result of the model is consistent with the labeled information of the test data. For example, the pulse field ablation control system 1200 can determine whether the lesion tissue features (such as type, volume and mass) recognized by the model are consistent with the labeled lesion tissue features.

[0102] Step 1350, determining whether the lesion tissue feature determination model meets the requirements.

[0103] In this step, the pulse field ablation control system 1200 can count the accuracy of the lesion tissue feature determination model test result, and determine whether the model meets the requirements based on the accuracy. Specifically, when the accuracy of the model test result exceeds a preset threshold (such as 85%, 90%, 95%, 98%, etc.), the pulse field ablation control system 1200 can consider that the trained model passes the test, and the model training method 1300 can proceed to step 1360. When the accuracy of the model test result is lower than the preset threshold, the pulse field ablation control system 1200 can consider that the trained model does not pass the test, and the model training method 1300 can re-perform step 1330.

[0104] Step 1360, output the trained lesion tissue feature determination model.

[0105] In some embodiments, the trained lesion tissue feature determination model can be applicable to the determination of lesion tissue features of multiple parts of the human body (such as bronchus, intestinal tract, gallbladder, etc.). In some embodiments, the pulse field ablation control system 1200 can respectively train corresponding lesion tissue feature determination sub-models according to different parts of the human body.

[0106] It should be noted that the above description of the model training method 1300 is only for example and illustration, and does not limit the scope of application of the present application. Those skilled in the art can make various modifications and changes to the model training method 1300 under the guidance of the present application. However, these modifications and changes are still within the scope of the present application. For example, the pulse field ablation control system 1200 can divide the labeled samples into a training set, a validation set and a test set, and when the lesion tissue feature determination model is initially trained, the pulse field ablation control system 1200 can use the validation set to verify the model. For another example, the pulse field ablation control system 1200 can periodically or irregularly update the model based on the situation of the model in use (such as user feedback on the model processing result).

[0107] Figure 14 is an exemplary flowchart of an ablation parameter determination model training method according to some embodiments of the present application. The ablation parameter determination model training method 1400 can be performed by the pulse field ablation control system 1200. As shown in Figure 14 , the training method 1400 can include:

[0108] Step 1410, obtaining a lesion tissue feature sample.

[0109] In some embodiments, the lesion tissue feature sample can include a feature of the lesion tissue in a historical ablation procedure. In some embodiments, the lesion tissue feature sample can include a combination of one or more of a type, a shape, a volume, and a mass of the lesion tissue, etc. In some embodiments, the lesion tissue feature sample can be obtained by a user (e.g., a medical staff) identifying. Specifically, the user can identify the feature of the lesion tissue based on an image of the lesion tissue in the site to be ablated, a location where the lesion tissue is located, a detection result of the lesion tissue, patient information, etc. In some embodiments, the lesion tissue feature sample can also be obtained by other manners. For example, the lesion tissue feature sample can be obtained by an image recognition model recognizing the image of the lesion tissue. For another example, the lesion tissue feature sample can be obtained by simulation. For yet another example, the lesion tissue feature sample can be obtained by a lesion tissue feature determination model. In some embodiments, the feature of the lesion tissue in the historical ablation procedure can be stored in a storage medium (e.g., a database), and the pulse field ablation control system 1200 can obtain the lesion tissue feature sample from the database.

[0110] At step 1420, an ablation parameter corresponding to the lesion tissue feature sample is obtained.

[0111] In some embodiments, the ablation parameter corresponding to the lesion tissue feature sample can be obtained by a user (e.g., a medical staff) labeling. For example, the user can determine the ablation parameter corresponding to the lesion tissue feature sample based on information (e.g., a type, a shape, a volume, and a mass of the lesion tissue, etc.) of the lesion tissue feature sample. For another example, the user can determine the ablation parameter corresponding to the lesion tissue feature sample by trial. In some embodiments, the user can label the ablation parameter corresponding to the lesion tissue feature sample by operating a terminal / human-computer interaction interface. Specifically, the user can input the ablation parameter information through the human-computer interaction interface. The manner of the user inputting the ablation parameter information can include, but is not limited to, voice input, text input, mouse selection input, touch screen input, etc. In some embodiments, the lesion tissue feature sample and the ablation parameter corresponding thereto can be stored in a database, and the pulse field ablation control system 1200 can obtain the ablation parameter corresponding to the lesion tissue feature sample from the database.

[0112] After performing steps 1410 and 1420, the pulse field ablation control system 1200 can obtain a plurality of sample pairs, each of which includes a lesion tissue feature sample and a corresponding ablation parameter. In some embodiments, as shown in FIG. 13, the pulse field ablation control system 1200 can obtain a plurality of sample pairs by performing steps 1410 and 1420 a plurality of times. Figure 14As shown, the pulse field ablation control system 1200 can divide the plurality of sample pairs into a model training set 1401 and a model testing set 1402. The model training set 1401 can be used to train the ablation parameter determination model; the model testing set 1402 can be used to test the ablation parameter determination model obtained by training. In some embodiments, the pulse field ablation control system 1200 can randomly divide the plurality of sample pairs in a certain ratio. For example, the ratio of the training set and the testing set can be 8:2, 9:1, 9.5:0.5, etc.

[0113] Step 1430, inputting the model training set into the initial ablation parameter determination model for training to obtain an ablation parameter determination model.

[0114] In some embodiments, the initial ablation parameter determination model can include, but is not limited to, one or any combination of a convolutional neural network model (CNN), a recurrent neural network model (RNN), a RCNN model (regions with CNN), a Fast-RCNN model, a BP neural network model, a K nearest neighbor algorithm model (KNN), a support vector machine model (SVM), etc.

[0115] Step 1440, testing the ablation parameter determination model.

[0116] In this step, the pulse field ablation control system 1200 can input the sample pair data in the model testing set 1402 into the trained ablation parameter determination model obtained in step 1430 for testing to obtain an output result. The pulse field ablation control system 1200 can further compare whether the output result of the model is consistent with the labeled information of the testing data. For example, the pulse field ablation control system 1200 can determine whether the ablation parameters recognized by the model are consistent with the labeled ablation parameters.

[0117] Step 1450, determining whether the ablation parameter determination model meets the requirements.

[0118] In this step, the pulse field ablation control system 1200 can count the accuracy of the testing result of the ablation parameter determination model, and determine whether the model meets the requirements based on the accuracy. Specifically, when the accuracy of the testing result of the model exceeds a preset threshold (such as 85%, 90%, 95%, 98%, etc.), the pulse field ablation control system 1200 can consider that the trained model passes the test, and the model training method 1400 can proceed to step 1460. When the accuracy of the testing result of the model is lower than the preset threshold, the pulse field ablation control system 1200 can consider that the trained model does not pass the test, and the model training method 1400 can re-proceed to step 1430.

[0119] At step 1460, the trained ablation parameter determination model is outputted.

[0120] It should be noted that the above description of the model training method 1400 is merely for example and illustration, and does not limit the scope of the application. Those skilled in the art can make various modifications and changes to the model training method 1400 under the guidance of the present application. However, these modifications and changes are still within the scope of the present application. For example, the pulse field ablation control system 1200 can divide the labeled samples into a training set, a validation set and a test set, and when the ablation determination model is initially trained, the pulse field ablation control system 1200 can use the validation set to verify the model. For another example, the pulse field ablation control system 1200 can periodically or irregularly update the model based on the situation of the model in use (such as user feedback on the processing result of the model).

[0121] The pulse field ablation control method and system of the embodiments of the present application can bring beneficial effects, including but not limited to: (1) the characteristics of the lesion tissue can be accurately and efficiently determined; (2) different pulse field ablation schemes can be provided for different lesion tissues for targeted ablation. It should be noted that different embodiments can have different beneficial effects, and in different embodiments, the beneficial effects that can be produced can be any one or a combination of the above, or any other beneficial effects that can be obtained.

[0122] The above is only a preferred embodiment of the present application, and does not limit the present application. Any modification, equivalent replacement and improvement made within the spirit and principle of the present application shall be included in the protection scope of the present application. The present application uses specific words to describe the embodiments of the present application. As "one embodiment", "an embodiment", and / or "some embodiments" means a certain feature, structure or characteristic related to at least one embodiment of the present application. Therefore, it should be emphasized and noted that the "an embodiment" or "one embodiment" or "an alternative embodiment" mentioned in different positions in the specification does not necessarily refer to the same embodiment. In addition, certain features, structures or characteristics in one or more embodiments of the present application can be properly combined.

[0123] Furthermore, various aspects of this application can be executed entirely by hardware, entirely by software (including firmware, resident software, microcode, etc.), or by a combination of hardware and software. The aforementioned hardware or software may be referred to as a "data block," "module," "engine," "unit," "component," or "system." Additionally, various aspects of this application may manifest as a computer product located on one or more computer-readable media, the product including computer-readable program code. A computer storage medium may contain a propagated data signal containing computer program code, for example, on baseband or as part of a carrier wave. This propagated signal may have various forms, including electromagnetic, optical, etc., or suitable combinations thereof. A computer storage medium can be any computer-readable medium other than a computer-readable storage medium, which can be connected to an instruction execution system, apparatus, or device to enable communication, propagation, or transmission of a program for use. Program code located on a computer storage medium can be propagated through any suitable medium, including radio, cable, fiber optic cable, RF, or similar media, or any combination of the above media.

[0124] The computer program code required for the operation of each part of this application can be written in any one or more programming languages, including object-oriented programming languages ​​such as Java, Scala, Smalltalk, Eiffel, JADE, Emerald, C++, C#, VB.NET, Python, etc., conventional procedural programming languages ​​such as C, Visual Basic, Fortran 12003, Perl, COBOL 12002, PHP, ABAP, dynamic programming languages ​​such as Python, Ruby, and Groovy, or other programming languages. This program code can run entirely on the user's computer, or as a standalone software package on the user's computer, or partially on the user's computer and partially on a remote computer, or entirely on a remote computer or server. In the latter case, the remote computer can be connected to the user's computer through any network, such as a local area network (LAN) or wide area network (WAN), or connected to an external computer (e.g., via the Internet), or in a cloud computing environment, or used as a service such as Software as a Service (SaaS).

[0125] Furthermore, the order of processing elements or sequences, or other names of components, unless specifically stated in the claims, are not intended to explicitly limit the order or use of such in the processes and methods disclosed. Although the above disclosure discusses some presently preferred embodiments of the application, the embodiments disclosed should not be construed to limit the scope of the application, which is defined by the appended claims. For example, although the system components described above can be implemented by hardware devices, they can also be implemented by software solutions only, such as installing the described system on an existing server or mobile device.

[0126] Similarly, it is to be noted that the foregoing description is directed to particular embodiments of the application for the purpose of illustration and description. It is not intended to limit the scope of the application beyond the breadth of the claims. Indeed, various features of the application can be combined in any suitable manner without departing from the scope of the application.

Claims

1. A pulsed field ablation catheter, characterized in that, Includes the inner tube and the elastic deformable body; The elastic deformable body is disposed at the front end of the inner tube, and at least one end of the elastic deformable body is fixedly connected to the inner tube. The middle part of the elastic deformable body can expand or contract. When the elastic deformable body contracts, the inner surface of the elastic deformable body is at least partially in contact with the inner tube. At least two annular electrodes are spaced apart on the outer side of the inner tube, and the at least two annular electrodes are located in the middle of the interior of the elastic deformable body. When the elastic deformable body is in an expanded state in the tissue lumen to support the diseased tissue, the at least two annular electrodes are located in the center of the diseased tissue, and the pulsed electric field is uniformly distributed in the center of the diseased tissue in the tissue lumen and uniformly covers the diseased tissue. The at least two annular electrodes are connected to the positive terminal of the energy generator, and the elastic deformable body is connected to the negative terminal of the energy generator; or... The at least two annular electrodes are connected to the negative electrode of the energy generator, and the elastic deformable body is connected to the positive electrode of the energy generator; The energy generator energizes the annular electrode and the elastic deformable body, thereby forming a pulsed electric field between the energized annular electrode and the elastic deformable body.

2. The pulsed field ablation catheter as described in claim 1, characterized in that, It also includes an outer tube, which is sleeved outside the inner tube, and the inner tube is movable relative to the outer tube; Both ends of the elastic deformable body are fixedly connected to the inner tube; the middle part of the elastic deformable body can automatically expand when it extends out of the outer tube, and the middle part of the elastic deformable body can automatically contract when it retracts into the outer tube.

3. The pulsed field ablation catheter as described in claim 2, characterized in that, The elastic deformable body has a mesh structure; the elastic deformable body is cut and formed from a first tube, and the diameter of the first tube is the same as the diameter of the middle part of the elastic deformable body in the expanded state.

4. The pulsed field ablation catheter as described in claim 1, characterized in that, It also includes an outer tube, which is sleeved outside the inner tube, and the inner tube is movable relative to the outer tube; The front end of the elastic deformable body is fixedly connected to the inner tube, and the rear end of the elastic deformable body is fixedly connected to the front end of the outer tube. The inner tube and the outer tube can move relative to each other to control the expansion or contraction of the elastic deformable body.

5. The pulsed field ablation catheter as described in claim 4, characterized in that, The elastic deformable body has a mesh structure; the elastic deformable body is cut and formed by a second tube, and the diameter of the second tube is the same as the diameter of the middle part of the elastic deformable body in the contracted state.

6. The pulsed field ablation catheter as described in claim 1, characterized in that, The pulsed field ablation catheter includes at least two elastic deformable bodies, which are spaced apart at the front end of the inner tube along the length of the inner tube.

7. The pulsed field ablation catheter as described in claim 6, characterized in that, At least two annular electrodes are spaced apart on the outer side of the inner tube, and two adjacent annular electrodes are respectively connected to the positive and negative electrodes of the energy generator; The pulsed field region formed by the at least two annular electrodes can cover the interval region of the at least two elastic deformable bodies.

8. The pulsed field ablation catheter as described in any one of claims 1-7, characterized in that, The pulsed field ablation catheter is used to treat lesions in the bronchi of the lungs; the elastic deformable body can adhere to the inner wall of the bronchus or the lesions in the bronchus when it is in an expanded state.

9. A pulsed field ablation device, characterized in that, The pulsed field ablation catheter included in any one of claims 1-8.

10. A pulsed field ablation device, characterized in that, Includes pulsed field ablation catheter and control handle; The pulsed field ablation catheter includes an inner tube, an elastic deformable body, and an outer tube; The elastic deformable body is disposed at the front end of the inner tube, at least one end of the elastic deformable body is fixedly connected to the inner tube, the middle part of the elastic deformable body can expand or contract, and when the elastic deformable body contracts, at least part of the inner surface of the elastic deformable body is in contact with the inner tube. The outer tube is sleeved outside the inner tube, and the inner tube is movable relative to the outer tube; At least two annular electrodes are spaced apart on the outer side of the inner tube, and the at least two annular electrodes are located in the middle of the interior of the elastic deformable body. When the elastic deformable body is in an expanded state in the tissue lumen to support the diseased tissue, the at least two annular electrodes are located in the center of the diseased tissue, and the pulsed electric field is uniformly distributed in the center of the diseased tissue in the tissue lumen and uniformly covers the diseased tissue. The at least two annular electrodes are connected to the positive terminal of the energy generator, and the elastic deformable body is connected to the negative terminal of the energy generator; or... The at least two annular electrodes are connected to the negative electrode of the energy generator, and the elastic deformable body is connected to the positive electrode of the energy generator; The energy generator energizes the annular electrode and the elastic deformable body, thereby forming a pulsed electric field between the energized annular electrode and the elastic deformable body. The control handle is used to control the relative movement of the inner tube and the outer tube, thereby controlling the expansion or contraction of the middle part of the elastic deformable body.

11. The pulsed field ablation device as described in claim 10, characterized in that, The control handle includes a housing and a control button, the control button being slidable relative to the housing; One of the inner tube or the outer tube is connected to the control button, and the other of the inner tube or the outer tube is connected to the outer shell; The control button can slide relative to the outer casing, thereby causing the inner tube and the outer tube to move relative to each other.

12. The pulsed field ablation device as described in claim 10, characterized in that, At least three annular electrodes are spaced apart on the outer side of the inner tube, and the energy generator can control the formation of a pulse field between any two adjacent annular electrodes.

13. The pulsed field ablation device as described in claim 10, characterized in that, The control handle also includes a bending control mechanism, which is used to control the bending of the front part of the outer tube.

14. The pulsed field ablation device as described in claim 10, characterized in that, The pulsed field ablation device also includes an endoscope, and the outer tube has a channel for the endoscope to pass through.

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