PFA ablation device and system

Abstract

The invention provides a PFA ablation device and system. The PFA ablation device comprises an ablation needle assembly and a conveying assembly. The conveying assembly comprises an adjustable bent catheter, the adjustable bent catheter comprises two inner cavities, the ablation needle assembly comprises at least one ablation unit, and each ablation unit comprises a first ablation needle and a second ablation needle opposite to the first ablation needle in polarity. The first ablation needle and the second ablation needle are movably arranged in the inner cavity in a penetrating mode. After the first ablation needle and the second ablation needle extend out of the far-end opening of the adjustable bent catheter, the distance between the corresponding extending parts of the first ablation needle and the second ablation needle in the radial direction of the adjustable bent catheter is gradually increased from near to far; therefore, the average distance between the first ablation needle and the second ablation needle can be increased, and the ablation range between the first ablation needle and the second ablation needle can be increased.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a PFA ablation device and system. Background Art

[0002] Hypertrophic cardiomyopathy (HCM) is a common autosomal dominant cardiovascular disease, which is mainly manifested by hypertrophy of one or more segments of the left ventricle (LV). The general diagnostic standard is a thickness greater than or equal to 15 mm. Its treatment methods mainly include drug therapy, surgical septal myectomy, and ventricular septal ablation.

[0003] Pulsed Field Ablation (PFA) can be used for ventricular septal ablation, such as Figure 1 As shown, the prior art discloses a double-needle PFA ablation device, wherein two mutually parallel ablation needles are arranged at intervals at the distal end of the ablation device, wherein the ablation needle 13 serves as the positive electrode and the ablation needle 14 serves as the negative electrode, and the proximal end of the ablation device is connected to an ablation device that provides energy, and the ablation device can be movably disposed in an adjustable bend catheter 12, and the adjustable bend catheter 12 can be movably disposed in an adjustable bend sheath 11, and under the guidance of the adjustable bend sheath 11 and the adjustable bend catheter 12, the ablation needles 13 and 14 can reach the target position, and then after the ablation device provides ablation energy to the two ablation needles, discharge occurs between the positive electrode and the negative electrode to break down the ventricular septum myocardial cells located between the two ablation needles and form irreversible electroporation (IRE), thereby completing PFA ablation.

[0004] Since the ablation device needs to enter the body through a catheter, and the ablation needles 13 and 14 are arranged in parallel, the distance between the ablation needles 13 and 14 is relatively close, resulting in a relatively small ablation range A of the ablation needles 13 and 14 . Summary of the invention

[0005] In order to solve the above technical problems, the present invention provides a PFA ablation device, including an ablation needle assembly and a delivery assembly;

[0006] The transport assembly includes an adjustable bend catheter, which includes at least two inner cavities. The ablation needle assembly includes at least one ablation unit. Each of the ablation units includes a first ablation needle and a second ablation needle with opposite polarity to the first ablation needle. The first ablation needle and the second ablation needle are respectively movably arranged in one of the inner cavities. After the first ablation needle and the second ablation needle extend out of the distal opening of the adjustable bend catheter, the distance between the corresponding extending parts of the first ablation needle and the second ablation needle in the radial direction of the adjustable bend catheter gradually increases from near to far.

[0007] The present invention also provides an ablation system comprising the above-mentioned PFA ablation device and an energy generating device, wherein the energy generating device is electrically connected to the first ablation needle and the second ablation needle of the PFA ablation device to provide energy for the PFA ablation device.

[0008] After the first ablation needle and the second ablation needle of the PFA ablation device and system of the present invention reach the target position through the catheter, the energy generating device is started to provide ablation energy to the first ablation needle and the second ablation needle, and ablate the tissue around the first ablation needle and the second ablation needle; after the distal ends of the first ablation needle and the second ablation needle extend out of the distal opening of the adjustable bend catheter, as the first ablation needle and the second ablation needle extend, the distance between the first ablation needle and the second ablation needle gradually increases from near to far, which can increase the average distance between the first ablation needle and the second ablation needle, and further increase the ablation range between the first ablation needle and the second ablation needle. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] In order to more clearly illustrate the technical solution of the embodiment of the present invention, the drawings required for use in the implementation mode will be briefly introduced below. Obviously, the drawings described below are some implementation modes of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0010] Figure 1 It is a schematic diagram of the structure of the PFA double ablation needle in the prior art;

[0011] Figure 2 A schematic diagram of the structure of an ablation device provided in Embodiment 1 of the present invention;

[0012] Figure 3A for Figure 2 A schematic diagram of a partially enlarged structure of a distal portion of an ablation device;

[0013] Figure 3B for Figure 3A A cross-sectional view of the ablation device at HH;

[0014] Figure 4 is a schematic diagram of a bevel needle tip;

[0015] Figure 5 for Figure 4 Schematic diagram of another perspective of the needle tip;

[0016] Figure 6 A schematic diagram of a needle tip having a first edge surface and a second edge surface;

[0017] Figure 7 for Figure 6 Schematic diagram of another perspective of the needle tip;

[0018] Figure 8 It is a schematic diagram of the structure of the adjustable bending sheath tube in a natural state in some embodiments of the present invention;

[0019] Fig. 9 It is a structural schematic diagram of the adjustable bending sheath tube in a straightening transition state;

[0020] Fig.10 It is a structural diagram of the adjustable bending sheath tube in a straightened state;

[0021] Fig.11 This is a schematic diagram of the structure of the adjustable bending sheath tube located in the aorta;

[0022] Fig.12 for Fig.11 Schematic diagram of the structure of the adjustable bending sheath tube at the aorta MM from another perspective;

[0023] Fig.13 It is a structural schematic diagram of another embodiment of an adjustable bending sheath tube;

[0024] Fig.14 for Fig.13 Another perspective diagram of the adjustable bending sheath tube;

[0025] Fig.15 It is a schematic diagram of the structure of an adjustable bending catheter and an adjustable bending sheath tube;

[0026] Fig.16 It is a schematic diagram of the structure of the distal end of the adjustable curved catheter crossing the aortic valve;

[0027] Fig.17 for Fig.16 Schematic diagram of the structure of the adjustable curved catheter at the aorta NN from another perspective;

[0028] Fig.18 It is a schematic diagram of adjusting the bend of the distal end of the adjustable bend catheter;

[0029] Fig.19 A schematic diagram of a partially enlarged structure of a distal portion of an ablation device provided in Embodiment 2 of the present invention;

[0030] Fig. 20 A schematic diagram of a partially enlarged structure of a distal portion of an ablation device provided in Embodiment 3 of the present invention;

[0031] Fig.21A A schematic diagram of a partially enlarged structure of a distal portion of an ablation device provided in Embodiment 4 of the present invention;

[0032] Fig. 21B is a schematic diagram of the structure of multiple concave parts;

[0033] Fig. 22 This is a schematic diagram of the tissue ablation area after the ablation device is withdrawn;

[0034] Fig.23 is a structural schematic diagram of an ablation system provided by Embodiment 5 of the present invention;

[0035] Fig.24 It is a structural schematic diagram of an ablation system provided in Example 6 of the present invention. DETAILED DESCRIPTION

[0036] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0037] The following descriptions of the various embodiments are made with reference to the attached drawings to illustrate specific embodiments in which the present invention may be implemented. The directional terms mentioned in the present invention, such as "top", "bottom", "front", "back", "left", "right", "inside", "outside", "side", etc., are only with reference to the directions of the attached drawings. Therefore, the directional terms used are for better and clearer description and understanding of the present invention, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore cannot be understood as limiting the present invention.

[0038] In the description of the present invention, it should be noted that, unless otherwise clearly stipulated and limited, the terms "installed", "connected", "connected", and "set on..." should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, and it can be the internal connection of two elements.

[0039] In the field of interventional medical devices, the proximal end of a medical device refers to the end closer to the operator, while the distal end of a medical device refers to the end farther from the operator; the axial direction refers to the direction parallel to the line connecting the distal and proximal centers of the medical device, the radial direction refers to the straight line direction along the diameter, and the circumferential direction refers to the direction around the axis of the cylinder. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0040] It should also be noted that the X direction mentioned in the text is the axial direction of the adjustable curved conduit 120, the Y direction is perpendicular to the X direction and along the radial direction of the adjustable curved conduit 120, and the XY plane refers to the plane where the X direction and the Y direction are located.

[0041] Embodiment 1:

[0042] like Figure 2 -3 and 23, embodiment 1 of the present invention provides a PFA ablation device 10, which includes an ablation needle assembly 3 and a conveying assembly; the conveying assembly includes an adjustable curved catheter 120, the adjustable curved catheter 120 includes two inner cavities, the ablation needle assembly 3 includes at least one ablation unit, each ablation unit includes an ablation needle 130 and an ablation needle 140 with opposite polarity to the ablation needle 130, the ablation needle 130 and the ablation needle 140 are respectively movably arranged in one of the inner cavities; after the ablation needle 130 and the ablation needle 140 extend out of the distal opening 124 of the adjustable curved catheter 120, the distance between the corresponding extending parts of the ablation needle 130 and the ablation needle 140 in the radial direction of the adjustable curved catheter 120 gradually increases from near to far.

[0043] Specifically, Figure 2 , 3A-3B, the delivery assembly includes an adjustable bending sheath tube 110 and an adjustable bending catheter 120, the proximal end of the adjustable bending sheath tube 110 is connected to the handle 1 and the handle 1 can bend the distal end of the adjustable bending sheath tube 110, the proximal end of the adjustable bending catheter 120 is connected to the handle 2 and the handle 2 can bend the distal end of the adjustable bending catheter 120, the adjustable bending catheter 120 can be movably arranged in the adjustable bending sheath tube 110, the proximal end of the adjustable bending catheter 120 can extend out of the proximal end of the adjustable bending sheath tube 110, and the distal end of the adjustable bending catheter 120 can extend out of the distal end of the adjustable bend sheath 110; the adjustable bend catheter 120 has two inner cavities, the ablation needles 130, 140 are respectively located in the two inner cavities, and the ablation needles 130, 140 can be movably arranged in the adjustable bend catheter 120, the proximal ends of the ablation needles 130, 140 are connected to the handle 4, and the handle 4 can advance or withdraw the ablation needle 130 and / or the ablation needle 140, so that the ablation needle 130 and / or the ablation needle 140 can extend out of the distal end of the adjustable bend catheter 120 or retract into the adjustable bend catheter 120. Among them, the ablation needle 130 and the ablation needle 140 with opposite polarity to the ablation needle 130 constitute an ablation unit. A PFA ablation device 10 can include at least one ablation unit at the same time, that is, a PFA ablation device 10 can include at least one ablation needle 130 and an ablation needle 140 at the same time. The following is an example of a PFA ablation device 10 with one ablation unit.

[0044] In a natural state, the ablation needle 130 is not subjected to external pressure, and an angle α is formed between the distal end portion of the ablation needle 130 and the proximal end portion of the ablation needle 130, and the ablation needle 140 is straight or quasi-straight. Through the above arrangement, after the ablation needles 130 and 140 extend from the distal end opening 124 of the adjustable bend catheter 120, an angle α is formed between the ablation needle 130 and the X direction, and the ablation needle 130 extends in a direction away from the ablation needle 140, and the ablation needle 140 extends in the X direction along the opening of the adjustable bend catheter 120, so an angle α is also formed between the ablation needles 130 and 140, so as the ablation needles 130 and 140 extend, the ablation needles 130 and 140 extend in a direction away from the ablation needle 140. The distance between the ablation needle 130 and the ablation needle 140 also increases linearly from near to far (i.e., the distance change rate a between the ablation needle 130 and the ablation needle 140 remains unchanged, where a=Δy / Δx, Δy is the distance increment between the ablation needle 130 and the ablation needle 140 in the Y direction, and Δx is the distance increment between the ablation needle 130 and the distal opening 124 in the X direction), thereby increasing the average distance between the ablation needle 130 and the ablation needle 140 (i.e., the average distance between the ablation needle 130 and the ablation needle 140 in the Y direction), reducing the overlapping part of the ablation range of the ablation needle 130 and the ablation needle 140, and further increasing the ablation range B between the ablation needles 130 and 140. Generally, the angle α is 10°-80°, preferably the angle α is 20°-70°, and more preferably the angle α is 30°-60°. The corresponding extended portion refers to the portion where the same plane perpendicular to the axial direction of the adjustable bend catheter 120 intersects with the ablation needle 130 and the ablation needle 140 .

[0045] In some embodiments, in a natural state, the ablation needles 130 and 140 are straight or quasi-straight, and an angle α is formed between the opening direction of the distal opening 124 of one of the inner lumens of the adjustable curved catheter 120 and the X direction. Through the above arrangement, the ablation needle 130 will also deflect after passing through the distal opening 124, so that an angle α is also formed between the part extending out of the distal opening 124 and the X direction. As the ablation needles 130 and 140 extend, the distance between the ablation needles 130 and 140 also continuously increases linearly (that is, the distance change rate a between the ablation needles 130 and 140 remains unchanged), thereby increasing the average distance between the ablation needles 130 and 140, and further increasing the ablation range B between the ablation needles 130 and 140, and the ablation range B is greater than the ablation range A.

[0046] like Figure 3BAs shown, the ablation needle 130 has an inner cavity, and the ablation needle 130 is provided with at least one perfusion hole 131. The proximal end of the inner cavity of the ablation needle 130 is connected to the handle 4, and the distal end of the inner cavity is connected to the perfusion hole 131, so that the perfusion hole 131 can act as the outlet of the inner cavity. Through the above arrangement, during PFA ablation, electrolyte liquid is perfused into the inner cavity, and the electrolyte liquid can flow out from the perfusion hole 131. Similarly, the ablation needle 140 also has an inner cavity and a perfusion hole 141, and its structure is the same as that of the ablation needle 130, which will not be repeated here.

[0047] When in use, the ablation needles 130 and 140 serve as positive / negative electrodes and negative / positive electrodes, respectively. If the electrical contact between the ablation needles 130 and 140 and the tissue is not good, it is easy to cause the contact impedance between the above two electrodes and the tissue to be too high, or even a tiny gap between the electrode and the tissue. When the above two electrodes apply high-voltage pulse energy, the gap between the above two electrodes and the tissue is broken down, forming a gap spark discharge, generating high temperature, sparks and even explosions locally, causing the temperature of the above two electrodes to rise rapidly, and also causing severe contraction and shaking of the tissue, which has an extremely adverse effect on the safety of treatment. In order to eliminate the above safety hazards, in the embodiment of the present application, the electrolyte liquid is injected into the inner cavity and flows out from the injection holes 131 and 141, so that the electrolyte liquid can be filled into the gap between the above electrodes and the tissue, enhancing the conductivity between the above two electrodes and the tissue, and reducing the possibility of heating and spark discharge.

[0048] The electrolyte liquid that can be used includes but is not limited to 0.9% NaCl solution at room temperature, 0.9% NaCl solution at 5°C, 5% glucose solution, heparinized 0.9% NaCl solution, a mixed solution of 0.9% NaCl solution and contrast agent, etc. Preferably, 0.9% NaCl solution at about 5°C is used.

[0049] The electrolyte liquid needs to flow in the inner cavity and flow out from the injection holes 131 and 141 , and the Reynolds number directly affects the flow state of the electrolyte liquid in the inner cavity. The larger the Reynolds number, the more unstable the flow of the electrolyte liquid.

[0050] Specifically, the Reynolds number is calculated according to the following formula:

[0051]

[0052] in:

[0053] Re——Reynolds number;

[0054] ρ——Fluid density, in kg / m 3 ;

[0055] v——fluid flow rate (i.e., perfusion flow rate), in m / s;

[0056] d——diameter of the inner cavity (i.e., the inner diameter of the ablation needle 130, 140), in m; generally, the diameter of the inner cavity (i.e., the inner diameter of the ablation needle 130, 140) is 0.1 mm-2 mm, preferably, the diameter of the inner cavity is 0.15 mm-1.2 mm, and more preferably, the diameter of the inner cavity is 0.3 mm-0.8 mm;

[0057] μ——Fluid viscosity, unit is Pa·s.

[0058] It can be seen that the greater the perfusion flow rate and the smaller the diameter of the inner cavity, the greater the Reynolds number; conversely, the smaller the Reynolds number. Since the larger the Reynolds number, the more turbulent the electrolyte liquid is when it flows in the inner cavity, resulting in unstable outflow of the electrolyte liquid from the perfusion hole 111, which is not conducive to perfusion ablation.

[0059] For the ablation needles 130 and 140, when the Reynolds number Re is between 10 and 1000, the electrolyte liquid can flow stably in the inner cavity with a smaller diameter, and the electrolyte liquid can flow out smoothly and stably from the perfusion hole 111, thereby ensuring that the electrolyte liquid can contact the outer surface and tissue of the ablation needles 130 and 140 in time to avoid excessive temperature rise of both. The Reynolds number is jointly determined by the fluid density ρ, the fluid flow rate v, the inner diameter of the ablation needles 130 and 140, and the fluid viscosity μ, so the corresponding Reynolds number can be obtained by adjusting the corresponding parameters.

[0060] The ablation needles 130 and 140 are preferably made of nickel-titanium alloy tubes with superelastic properties, so that the ablation needles 130 and 140 are elastic. The ablation needles 130 and 140 can reach the ventricular septum by puncturing the epicardium through the apex or reach the ventricular septum by puncturing the endocardium through the vascular intervention path via the catheter; during the catheter intervention, in order to align the ablation needles 130 and 140 with the puncture point of the ventricular septum, the ablation needles 130 and 140 need to be bent multiple times under the drive of the adjustable bend catheter 120, so the ablation needles 130 and 140 have certain flexibility and elasticity, and can smoothly pass through the winding blood vessels without being damaged and losing elasticity and being unable to restore the original shape. Therefore, it is preferred to use a nickel-titanium alloy with superelastic properties. This material can undergo corresponding deformation when subjected to an external force, and recover to its original shape after the external force is unloaded. It can be suitable for the application scenarios of this device. At the same time, since the nickel-titanium material will form a stable titanium oxide layer on the outer layer, the material has good chemical stability, strong corrosion resistance, and good biocompatibility. At this time, the ablation needles 130 and 140 as a whole serve as electrodes.

[0061] In other embodiments, an insulating layer may be attached to the outer surface of the ablation needles 130 and 140, and the exposed area at the distal end of the ablation needles 130 and 140 that is not covered by the insulating layer serves as an electrode for releasing ablation energy. The insulating layer may be a layer of polymer material coated on the ablation needles 130 and 140 by heat shrinking, or may be directly sleeved on the outside of the ablation needles 130 and 140, or may be attached to the outside of the ablation needles 130 and 140 by a coating process. The outer surface of the insulating layer should have a low friction coefficient and a high insulation resistance. The low friction coefficient can give the ablation needles 130 and 140 good lubricity and pushing performance, and the high insulation resistance can enable the insulating layer to maintain excellent dielectric insulation without being broken down under the action of high-frequency pulses.

[0062] When the insulating layer is wrapped on the outside of the ablation needle 130, 140 by heat shrinking, the insulating material is preferably PET (polyethylene terephthalate), PTFE (polytetrafluoroethylene), FEP (fluorinated ethylene propylene) and other materials. When the insulating layer is fixed on the outside of the ablation needle 130, 140 by sleeve installation, the insulating layer is preferably made of PEEK (polyetheretherketone), PI (polyimide) and other materials. When the insulating layer is adhered to the outside of the ablation needle 130, 140 by a coating process, the insulating material is preferably Parylene (polyparaxylene).

[0063] In some other possible embodiments, the ablation needles 130 and 140 may also be made of polymer materials. In this case, at least one component with good electrical conductivity should be fixed on the ablation needles 130 and 140. Specifically, one or more ring-shaped metal electrodes are fixed to the distal ends of the ablation needles 130 and 140 by means including but not limited to bonding, welding, crimping, welding, etc., and are electrically connected to the external energy generating device through a wire. The metal electrode is preferably made of a radiopaque metal material such as platinum-iridium alloy, cobalt-chromium alloy, tantalum, etc., so that it has excellent electrical conductivity and can also have a development effect under radiation, which helps the operator to confirm the position of the metal electrode.

[0064] When the ablation needles 130 and 140 are made of polymer materials, the polymer materials used should have excellent strength, hardness, high elastic modulus and good bending resistance, and should not break or plastically deform under repeated bending. On the other hand, in order to ensure that the ablation needles 130 and 140 have excellent pushing performance during the forward and backward movement along the central axis of the adjustable curved catheter 120, the material should have a low surface friction coefficient, which can reduce the pushing resistance of the ablation needles 130 and 140 in the lumen of the adjustable curved catheter 120. At the same time, in order to ensure the insulation of the ablation needles 130 and 140, the material should have excellent dielectric insulation, high insulation resistance, small dielectric constant, and high voltage resistance. Therefore, the ablation needles 130 and 140 are preferably made of polymer materials such as polypropylene PP, high-density polyethylene HDPE, and polytetrafluoroethylene PTFE.

[0065] In some possible embodiments, the insulating layer contains a material with ultrasound absorption. Through the above configuration, under ultrasound, the insulating layer has a lower echo, and the ablation needles 130, 140 or the metal electrodes have a higher echo. Therefore, under ultrasound imaging, the operator can easily identify the positions of the ablation needles 130, 140 or the metal electrodes, which can avoid prolonged operation time due to difficulty in identifying the positions of the ablation needles 130, 140 or the metal electrodes. At the same time, it can also avoid incorrect ablation position errors caused by misidentification of the positions of the ablation needles 130, 140 or the metal electrodes, which can cause adverse effects on patients.

[0066] like Figure 4-5 As shown, the ablation needle 130 has a needle tip 132, and the needle tip 132 is a closed and sharp tip structure, and its shape includes but is not limited to a cone, a triangular pyramid, a quadrangular pyramid, a single-bevel blade, etc. The shape of the needle tip 132 can provide the ablation needle 130 with a sufficiently sharp needle tip 132 structure, so that it can pierce the endocardial or epicardial tissue with a smaller puncture force, thereby smoothly entering the ventricular septum myocardial tissue.

[0067] The ablation needle 130 is integrally formed by laser cutting, grinding, wire cutting and other processing methods. The needle tip 132 is a beveled structure and is provided with a first blade surface 1321. The first blade surface 1321 forms an angle γ with the axial direction of the distal end of the ablation needle 130. The above arrangement can enhance the sharpness of the needle tip 132, so that the operator only needs to apply a small force to the ablation needle to puncture the endocardium to ablate the ventricular septum tissue. The angle γ is 10°-45°, preferably 15°-40°, and more preferably 20°-35°.

[0068] In some embodiments, Figure 6-7As shown, the distal end of the first blade surface 1321 is also provided with two second blade surfaces 1322 symmetrical with respect to the first blade surface 1321, and the distal ends of the second blade surfaces 1322 intersect at the farthest end of the first blade surface 1321, and each second blade surface 1322 forms an angle δ with the axial direction of the ablation needle 130, so that the first blade surface 1321 and the second blade surface 1322 are located in different planes. Through the above arrangement, during the puncture of the needle tip 132, the two second blade surfaces 1322 cut the tissue on their respective planes, and the first blade surface 1321 cuts the tissue on another plane, thereby forming at least 3 incisions in the tissue, which is convenient for the perfusion liquid to enter the tissue through the above incisions during perfusion ablation and diffuse to a farther part, which is beneficial to enhancing the ablation range; at the same time, the first blade surface 1321 and the second blade surface 1322 cut the tissue in different directions, thereby further enhancing the sharpness of the needle tip 132 and allowing the needle tip 132 to puncture the tissue more quickly. The angle δ is 10-45°, preferably 15-40°, and more preferably 20-35°. In addition, the surface of the needle tip 132 may be plated with a layer of gold coating or other coating materials with strong developing performance to enhance the developing performance of the needle tip 132 under external imaging equipment.

[0069] In some embodiments, the needle tip 132 and the ablation needle 130 are split structures. The needle tip 132 is a separately processed needle head, and the distal end of the needle tip 132 is in a shape including but not limited to a cone, a triangular pyramid, a quadrangular pyramid, a single bevel edge, etc., and its proximal end is fixedly connected to the distal end of the ablation needle 130 by means including but not limited to bonding, welding, etc. In this embodiment, the ablation needle 130 is made of a metal tube with good electrical conductivity and a hollow inner cavity, which can achieve electrical conduction, thereby achieving the purpose of the needle tip 132 and the ablation needle 130 releasing ablation energy. At the same time, a temperature sensor can be set in the inner cavity to monitor the real-time temperature of the distal end of the ablation needle 130 during ablation. The structure of the ablation needle 140 is the same as that of the ablation needle 130, and will not be repeated here.

[0070] See also Figure 2 , Figure 8 , below, taking the adjustable curved sheath 110 entering the left ventricle through the aorta as an example, when other pathways are used to ablate the ventricular septum tissue, the structure of the adjustable curved sheath 110 can be adaptively adjusted with reference to the corresponding pathways.

[0071] The adjustable bending sheath tube 110 includes an adjustable bending sheath tube 110 and a handle 1, wherein the adjustable bending sheath tube 110 is a prefabricated pipe fitting with certain rigidity and flexibility. The adjusting component adjusts the shape of the adjustable bending sheath tube 110 by applying a force to the adjustable bending sheath tube 110. After the force of the adjusting component is eliminated, the adjustable bending sheath tube 110 can gradually return to its natural state. The adjustable bending sheath tube 110 has a hollow inner cavity.

[0072] The adjustable bending sheath tube 110 includes a first tube segment 111, a second tube segment 112 and a third tube segment 113 which are sequentially connected from the proximal end to the distal end.

[0073] As a possible implementation, in a natural state, the first tube segment 111, the second tube segment 112 and the third tube segment 113 are all located on the same plane, the second tube segment 112 first extends in a direction away from the first tube segment, and then extends in a direction close to the first tube segment 111, and the third tube segment 113 extends in a direction close to the first tube segment 111, so that the first tube segment 111 is adapted to the shape of the descending aorta of the human body, the second tube segment 112 is adapted to the shape of the aortic arch of the human body, and the third tube segment 113 is adapted to the shape of the ascending aorta of the human body, and the distal end of the third tube segment 113 is close to the middle part of the aortic valve of the human body. Therefore, the adjustable curved sheath tube 110 under this implementation has a predetermined shape in a natural state, which matches the shape of the human aorta, and is convenient for entering the left ventricle from the aorta across the aortic valve to treat the myocardial tissue.

[0074] See also Figure 8 , the adjustable bending sheath tube 110 is in a natural state. The handle 1 is connected to the adjustable bending sheath tube 110, which is used to adjust the shape of the adjustable bending sheath tube 110. By operating the handle 1, the adjustable bending sheath tube 110 can be adjusted in a straightened state (such as Fig.10 shown) and the natural state (as Figure 8 The straightening state refers to a state in which the shape of the adjustable bending sheath tube 110 is approximately a straight line by the handle 1. Specifically, the handle 1 is operated to apply an external force opposite to the direction F shown in the figure to the adjustable bending sheath tube 110 so that the shape of the adjustable bending sheath tube changes from the natural state (as shown in the figure) to the straightening state. Figure 8 The bending shape under the transition state (as shown) Fig. 9 As shown) into an approximately straight line shape (i.e., a straightened state, such as Fig.10As shown). Therefore, before intervening in the human body, the adjustable bending sheath tube 110 is first adjusted from the natural state to the straightened state. As the adjustable bending sheath tube 110 penetrates into the human vascular path, the self-straightened state gradually changes to the natural state, and finally restores the natural state. Then, the distal end of the adjustable bending sheath tube 110 can also be bent by operating the handle 1. At this time, the adjustable bending sheath tube 110 is in the bent state. Specifically, an anchor ring is provided at the distal end of the third tube section 113 of the above-mentioned adjustable bending sheath tube 110, and the above-mentioned anchor ring is connected to the distal end of the traction wire built into the above-mentioned adjustable bending sheath tube 110, and the proximal end of the above-mentioned traction wire is connected to the above-mentioned handle 1. Therefore, the handle 1 can adjust the degree of curvature of the third tube segment 113 by pushing and pulling the traction wire. When the third tube segment 113 is bent to a certain degree away from the first tube segment 111, it can continue to adjust. At this time, it can affect the second tube segment 112 and gradually straighten the second tube segment 112, and finally adjust the first tube segment 111, the second tube segment 112, and the third tube segment 113 to a straight line or a state of approximate straight lines. Therefore, the adjustable bending sheath tube 110 can be put into a straightened state by operating the handle 1. Since the adjustable bending sheath tube 110 is straightened by operating the handle 1, the third tube segment 113 of the adjustable bending sheath tube 110 in the straightened state during this operation will be partially bent, but this part does not affect the overall entry of the adjustable bending sheath tube 110 into the relevant blood vessel path. As the adjustable bending sheath tube 110 penetrates into the human vascular path, the external force applied to the handle 1 is gradually reduced, so that the self-straightening state of the adjustable bending sheath tube 110 gradually changes to a natural state, and finally restores the natural state. Alternatively, in some embodiments, the operator can also insert a dilator into the adjustable bending sheath tube 110, and use the dilator to straighten the adjustable bending sheath tube 110, so that the first tube segment 111, the second tube segment 112, and the third tube segment 113 are adjusted to a straight line or a nearly straight line state, and then as the adjustable bending sheath tube 110 penetrates into the human vascular path, the dilator is gradually withdrawn to make the self-straightening state gradually change to a natural state, and finally restore the natural state, and then the distal end of the adjustable bending sheath tube 110 can be adjusted by operating the handle 1, and at this time, the adjustable bending sheath tube 110 is in a bending state.

[0075] By such arrangement, the adjustable bend sheath tube 110 in a natural state fits the shape of the aorta, wherein the first tube segment 111 is similar to or identical to the shape of the descending aorta, the second tube segment 112 is similar to or identical to the shape of the aortic arch, and the third tube segment 113 is similar to the shape of the ascending aorta, so that when the adjustable bend sheath tube 110 is inserted into the aorta and restored to a natural state, the distal end of the third tube segment 113 will be close to the middle part of the aortic valve, and when the distal opening of the third tube segment 113 is not facing the aortic valve or a predetermined direction, the direction of the distal opening of the third tube segment 113 can be adjusted by operating the handle 1, and at this time, the adjustable bend sheath tube 110 is in a bending state.

[0076] In the prior art, the adjustable sheath tube is a straight line or an approximately straight line as a whole in a natural state. The operator applies external force through the handle to adjust the bending degree of the distal end of the adjustable sheath tube, and the handle state needs to be maintained after the adjustable sheath tube becomes the target shape; in the present embodiment, the adjustable sheath tube 110 is a predetermined shape in a natural state, that is, the third tube segment 113, the second tube segment 112 and the first tube segment 111 are located in the same plane, the second tube segment 112 first extends in a direction away from the first tube segment 111 and then extends in a direction toward the first tube segment 111, and the third tube segment 113 extends in a direction toward the first tube segment 111. Before the adjustable sheath tube 110 enters the aorta, the operator applies external force through the handle 1 or inserts a dilator into the adjustable sheath tube 110. The device is used to adjust the adjustable sheath tube 110 to a straight line or an approximate straight line. In the process of passing through the descending aorta, the aortic arch and reaching the ascending aorta, the straightening external force applied by the handle 1 to the adjustable sheath tube 110 is gradually reduced or the dilator is withdrawn, so that the first tube segment 111, the second tube segment 112 and the third tube segment 113 of the adjustable sheath tube 110 gradually return to a natural state. At this time, in the adjustable sheath tube 110 after entering the heart, the distal end of the third tube segment 113 reaches the ascending aorta and its opening points to the direction of the aortic valve close to the mitral valve, the second tube segment 112 is located in the aortic arch, and the first tube segment 111 is located in the descending aorta. The operator does not need to apply any external force to the handle 1, thereby improving the surgical efficiency, avoiding the operator from pulling the handle 1 for a long time, and reducing the possibility of misoperation. If the distal opening of the third tube segment 113 is not facing the aortic valve or the predetermined direction, the direction of the distal opening of the third tube segment 113 can be adjusted by operating the handle 1, and the adjustable sheath tube 110 is in a bending state.

[0077] The shape of the third tube segment 113 in the natural state can ensure that the distal end of the third tube segment 113 moves in two directions close to the ventricular septum or away from the ventricular septum, thereby facilitating the subsequent selection of different puncture sites and providing different positions for the adjustable bend catheter 120 and the ablation needle 13 installed in the adjustable bend sheath 110.

[0078] See also Fig.11 , Fig.12 Furthermore, the swing of the third tube segment 113 can be controlled by controlling the circumferential rotation of the adjustable bend sheath tube 110 through the adjusting component to control the direction of the distal opening of the third tube segment 113; specifically, when the adjustable bend sheath tube 110 is controlled to rotate clockwise through the adjusting component, the third tube segment 113 will swing toward the side of the aortic arch close to the chest cavity. It can be known that when the adjustable bend sheath tube 110 is controlled to rotate counterclockwise, the third tube segment 113 will swing toward the side of the aortic arch close to the back.

[0079] By controlling the swing of the third tube segment 113, the different orientations of the distal opening of the third tube segment 113 can be controlled, and the adjustable bend catheter 120 inserted in the adjustable bend sheath tube 110 can be controlled to extend from the distal opening of the third tube segment 113 at different angles.

[0080] In some possible implementations, in a natural state, the first tube segment 111 is in a straight line.

[0081] In some possible implementations, the proximal end of the first tube segment 111 is straight, and the distal end is curved.

[0082] In some possible implementations, the curved portion of the third tube segment 113 may be in a regular or irregular curve shape, preferably in an arc shape.

[0083] In some possible implementations, in a natural state, the second pipe segment 112 is curved, and the middle portion thereof is arched relative to the two ends. Further, the second pipe segment 112 may be in a regular or irregular curved shape, and the second pipe segment 112 is preferably in an arc shape, so that the connection transition between the first pipe segment 111 and the third pipe segment 113 is smooth.

[0084] In some possible implementations, in a natural state, the third tube segment 113 is curved, and the curvature of the proximal portion of the third tube segment 113 is smaller than the curvature of the distal portion of the third tube segment 113, that is, the degree of curvature of the distal portion of the third tube segment 113 is greater than the degree of curvature of the proximal portion. Under the premise that the distal portion of the second tube segment 112 and the third tube segment 113 extend toward the first tube segment 111, the distal portion of the third tube segment 113 will move closer to the first tube segment 111.

[0085] Through the above-mentioned arrangement, when the third tube segment 113 is located in the ascending aorta in a natural state, the distal end of the third tube segment 113 is located close to the middle part of the aortic valve and biased towards the descending aorta, that is, the distal end of the third tube segment 113 is away from the ventricular septum, thereby increasing the distance from the distal end of the third tube segment 113 to the ventricular septum, thereby increasing the selection range of the adjustable bend sheath tube 110 and the adjustable bend catheter 120.

[0086] In some possible implementations, the first pipe segment 111 , the second pipe segment 112 , and the third pipe segment 113 have different curvatures, and the curvature of the second pipe segment 112 is greater than that of the first pipe segment 111 and the third pipe segment 113 , and the curvature of the third pipe segment 113 is greater than that of the first pipe segment 111 .

[0087] In some possible implementations, the curvature of the second tube segment 112 may remain unchanged, or may be configured such that, from the proximal end to the distal end, the curvature of the second tube segment 112 first increases and then decreases, or gradually increases.

[0088] When the curvature of the second tube segment 112 remains unchanged, the second tube segment 112 has substantially no conflict with the aortic arch, and the damage to the blood vessel wall is minimal.

[0089] When the curvature of the second tube segment 112 increases first and then decreases, the second tube segment 112 partially contacts the aortic arch and the contact area is small. The force provided by the blood vessel wall to the second tube segment 112 can help the adjustable sheath tube 110 maintain its position.

[0090] When the curvature of the third tube segment 112 gradually increases, the second tube segment 112 partially interferes with the aortic arch and the interference area is relatively large, which can increase the force provided for positioning the second tube segment 112 .

[0091] See also Figure 13-14 In some embodiments, some changes are made to the shape of the adjustable bending sheath tube 110, and the only difference from the above embodiments is that: in the natural state, the first tube segment 111 and the second tube segment 112 of the adjustable bending sheath tube 110 are located in the first plane 91, and the third tube segment 113 is located in the second plane 92 having an angle θ with the first plane 91.

[0092] Specifically, considering that the aortic arch is not a planar structure but a three-dimensional spatial structure, therefore, according to the actual shape of the aortic arch, in this embodiment, the third tube segment 113, the second tube segment 112 and the first tube segment 111 of the adjustable bend sheath tube 110 are also correspondingly set to a three-dimensional spatial structure, wherein the second tube segment 112 and the first tube segment 111 are located in the same plane 91, and the third tube segment 113 is located in the second plane 92 forming a certain angle with the first plane 91.

[0093] According to the actual shape of the aortic arch, the bending direction F of the third tube segment 113 is toward the side of the aortic arch close to the human chest. The above setting can make the adjustable sheath tube 110 better fit the shape of the aortic arch.

[0094] In some possible implementations, 10°≤θ≤45°; further, θ is preferably 15°, 20°, 25°, 30°, 35° or 40°.

[0095] In some embodiments, the ablation device can perform endocardial puncture and ablation on the ventricular septum via a path such as the inferior vena cava-right atrium-right ventricle or the inferior vena cava-right atrium-atrial septum-left atrium-left ventricle, and the structure of the adjustable sheath 110 can be adaptively adjusted with reference to this embodiment.

[0096] The structure of the adjustable curved sheath tube 110 that enters the left ventricle through the aorta is used as an example below to illustrate the structure of the adjustable curved catheter 120. When other paths are used to ablate the ventricular septum, the structure of the adjustable curved catheter 120 is adaptively adjusted with reference to this embodiment.

[0097] See also Fig.15 The adjustable bend catheter 120 has at least a main section 121, a shaping section 122 and a bend adjustment section 123 from the proximal end to the distal end. The shape of the main section 121 is adapted to the shape of the first section 111 of the adjustable bend sheath tube 110, and the shape of the shaping section 122 is adapted to the shapes of the second section 112 and the third section 113 of the adjustable bend sheath tube 110, so as to achieve better adaptability of the adjustable bend catheter 120 and the adjustable bend sheath tube 110 in terms of structural morphology. The adjustable bend catheter 120 is disposed in the hollow inner cavity of the adjustable bend sheath tube 110, and can realize relative movement with the adjustable bend sheath tube 110 along the central axis direction.

[0098] Specifically, when the adjustable bending sheath tube 110 of the above embodiment is used, the distal end portion of the shaping section 122 extends in the direction away from the interventricular septum, and the bending adjustment section 123 extends in the direction toward the interventricular septum.

[0099] See also Figure 16-18 When the adjustable bend sheath 110 is located in the aorta and is in a natural state, the adjustable bend catheter 120 is transported through the inner cavity of the adjustable bend sheath 110, and the bend adjustment section 123 extends from the distal opening of the third tube section 113 of the adjustable bend sheath 110, crosses the aortic valve, and reaches the LVOT (left ventricular outflow tract) position. At this time, the adjustable bend catheter 120 is in a natural state (not adjusted).

[0100] The adjustable bend conduit 120 is connected to a bend adjustment handle 2 , and the circumferential swing of the bend adjustment section 123 of the adjustable bend conduit 120 can be controlled by controlling the rotation of the bend adjustment handle 2 of the adjustable bend conduit 120 .

[0101] Through the joint rotation of the third tube section 113 of the adjustable sheath tube 110 and the bending section 123 of the adjustable bending catheter 120, different orientations of the bending section 123 of the adjustable bending catheter 120 can be achieved, thereby achieving point selection at different positions on the ventricular septum.

[0102] like Fig.18As shown, the bending direction G of the bending section 123 can be toward the outside of the aortic arch, that is, toward the interventricular septum. By controlling the bending handle 2 of the adjustable bending catheter 120, the bending section 123 can be bent toward the outside of the aortic arch 42, thereby ensuring that the distal end of the bending section 123 is always toward the side of the interventricular septum, so that the ablation needle 13 has the correct needle exit angle and direction during puncture.

[0103] When the bending section 123 is bent to a suitable angle in the G direction, the distal end of the bending section 123 will contact the left ventricular side wall of the interventricular septum, thereby preparing for subsequent needle removal.

[0104] The distal end of the shaping section 122 extends in the direction away from the interventricular septum, and the bending adjustment section 123 extends in the direction of the interventricular septum, that is, the shape of the distal end of the adjustable bending catheter 120 is set in a manner of first moving away from and then approaching the interventricular septum. Through the above setting, the distal opening angle of the bending adjustment section 123 can be increased by adopting a manner of first moving away from and then approaching the interventricular septum, which is beneficial to the implementation of the operation.

[0105] Embodiment 2:

[0106] See also Fig.19 The second embodiment of the present invention provides a PFA ablation device. The PFA ablation device of this embodiment is different from the PFA ablation device of the first embodiment only in that the ablation needle assembly 3a is different.

[0107] Specifically, the ablation needle assembly 3a includes ablation needles 130 and 140a. In a natural state, the distal end of the ablation needle 130 has an angle α with the X direction, the distal end of the ablation needle 140 has an angle β with the X direction, and the ablation needle 140a extends in a direction away from the ablation needle 130. Through the above arrangement, after the ablation needles 130 and 140a extend from the distal end opening of the adjustable bend catheter 120, the ablation needle 130 and the ablation needle 140a have an angle α+β between them. As the ablation needles 130 and 140a extend, the angle α+β between the ablation needles 130 and 140a increases. 140a, the distance between the ablation needle 130 and the ablation needle 140a also increases linearly (that is, the distance change rate b between the ablation needle 130 and the ablation needle 140a remains unchanged, wherein the calculation method of b is the same as the distance change rate a and b is greater than a), thereby increasing the average distance between the ablation needle 130 and the ablation needle 140a, reducing the overlapping part of the ablation range of the ablation needle 130 and the ablation needle 140a, and further increasing the ablation range C between the ablation needles 130 and 140a. Generally, the angle β is 10°-80°, preferably the angle β is 20°-70°, and more preferably the angle β is 30°-60°; therefore, the angle α+β between the ablation needle 130 and the ablation needle 140a is 20°-160°.

[0108] In some embodiments, in a natural state, the ablation needles 130 and 140a are straight or quasi-straight, and an angle α is formed between the opening direction of the distal end opening 124 of one inner cavity of the adjustable curved catheter 120 and the X direction, and an angle β is formed between the distal end opening direction of the other inner cavity and the X direction. Through the above arrangement, the ablation needles 130 and 140a are deflected after extending from the distal end opening of the adjustable curved catheter 120, so that the portion of the ablation needles 130 and 140a extending from the distal end opening is aligned with the X direction. There are angles α and β between the directions respectively. As the ablation needles 130 and 140a are extended, the distance between the ablation needles 130 and 140a also increases linearly (that is, the distance change rate b between the ablation needles 130 and 140a remains unchanged, where b is greater than a), thereby further increasing the average distance between the ablation needles 130 and 140a, and then increasing the ablation range C between the ablation needles 130 and 140a; the ablation range C is greater than the ablation range B.

[0109] Embodiment three:

[0110] See also Fig. 20 The third embodiment of the present invention provides a PFA ablation device. The PFA ablation device of this embodiment is different from the PFA ablation devices of the first and second embodiments only in that the ablation needle assembly 3b is different.

[0111] Specifically, the ablation needle assembly 3b includes ablation needles 230 and 240, and the ablation needles 230 and 240 are respectively provided with perfusion holes 231 and 241. In a natural state, the distal ends of the ablation needles 230 and 240 have a curved portion, and the curved portion extends away from the central axis of the adjustable bend catheter 120, and the curvature of the curved portion is consistent, so that the needle tips of the ablation needles 230 and 240 are both away from the central axis of the adjustable bend catheter 120. Through the above-mentioned setting, as the ablation needles 230 and 240 extend, the distance between the ablation needles 230 and 240 increases nonlinearly, and the rate of change c of increase in the distance between the ablation needles 230 and 240 continues to increase, so that the average distance between the ablation needles 230 and 240 can be quickly increased, and the overlapping part of the ablation range of the ablation needles 230 and 240 is reduced, and the ablation range D between the ablation needles 230 and 240 can be further increased, and the ablation range D can be greater than the ablation range C.

[0112] In some embodiments, the curvature of the curved portion gradually increases. Through the above configuration, the average distance between the ablation needle 230 and the ablation needle 240 can be further quickly increased, thereby further increasing the ablation range D between the ablation needles 230 and 240.

[0113] Embodiment 4:

[0114] See also Fig.21A The fourth embodiment of the present invention provides a PFA ablation device. The PFA ablation device of this embodiment is different from the PFA ablation device of the third embodiment only in that the ablation needle assembly 3c is different.

[0115] Specifically, the ablation needle 230a is provided with an inner recess 232 recessed into the interior of the ablation needle 230a. When the distal end of the ablation needle 230a is located in the tissue, part of the tissue surrounding the ablation needle 230a is located in the inner recess 232. When the energy generating device 20 provides PFA ablation energy to the ablation needle 230a, a voltage difference exists between the ablation needle 230a (positive or negative electrode) and the ablation needle 240a (negative or positive electrode), and a pulse ablation occurs. Since the part of tissue is located in the inner concave portion 232 and the ablation area of ​​the PFA ablation device, the part of tissue will also be affected by the PFA ablation energy and produce irreversible electroporation. After ablation, the projection of the ablated tissue on the XY plane is the ablation area D. After the ablation needle 230a is withdrawn from the tissue, the tissue in the ablation area D loses the squeezing effect of the ablation needle 230a, and the projection of the ablated tissue on the XY plane is the ablation area E. Fig. 22 As shown. Since the ablation needle 230 in the third embodiment has no inner concave portion, its volume is relatively large; while the ablation needle 230a in this embodiment is provided with an inner concave portion 232, its volume is relatively small compared to the ablation needle 230; in the case where the ablation areas that can be ablated by the ablation needles are the same and the ablation needles need to occupy a certain volume of the ablation area, the smaller the volume of the ablation needle, the more tissues can be ablated, so the ablation area E is larger than the ablation area D.

[0116] It can be seen that by providing the inner concave portion 232, more tissues close to the ablation needle 230a and equivalent to the size of the inner concave portion 232 can be ablated by the ablation needle 230a and the ablation needle 240a, thereby increasing the ablation range of the PFA ablation device 10 and improving the ablation efficiency. Similarly, providing the inner concave portion 242 on the ablation needle 240a can also play the same role.

[0117] Due to the existence of the inner recess 232, the diameter of the inner cavity portion corresponding to the inner recess 232 is smaller than the diameter of other portions of the inner cavity, that is, the diameter of the inner cavity is large-small-large from the proximal end to the distal end, and the portion with a smaller diameter is close to the perfusion hole 231. Therefore, in the process of the electrolyte liquid flowing from the proximal end to the distal end of the inner cavity, it needs to pass through a narrow inner cavity to reach the perfusion hole 231. Therefore, the electrolyte liquid will increase its flow rate when flowing through this portion of the inner cavity, so that the electrolyte liquid can reach the perfusion hole 231 faster and flow out of the perfusion hole 231, which can improve the perfusion efficiency and is beneficial to perfusion ablation.

[0118] like Fig. 21B As shown, in some embodiments, at least two inner recesses 232 are provided on the ablation needle 230a, and two adjacent inner recesses 232 are spaced apart in a single spiral manner along the direction of the central axis of the ablation needle 230a. Specifically, on a radial section perpendicular to the central axis of the ablation needle 230a, there is only one inner recess 232 in the same radial section, and two inner recesses 232 adjacent along the X direction are staggered in the Z direction (the Z direction is the circumferential direction of the ablation needle), and two or more inner recesses 232 arranged in this regular pattern continuously form a single spiral structure H1, and at this time, the two or more inner recesses 232 are evenly distributed in the X direction. Through the above arrangement, on the radial cross section of the ablation needle 230a, it is ensured that there is only one inner concave portion 232 in the same radial cross section, avoiding the situation where the strength of the ablation needle 230a needle body is reduced due to multiple inner concave portions 232 distributed on the same radial cross section, thereby ensuring the strength and structural stability of the ablation needle 230a needle body itself, so that when the ablation needle 230a passes through the blood vessel and adjusts the bend, the structural strength of the ablation needle 230a will not be greatly reduced and the ablation needle 230a needle body will not be broken due to the existence of the inner concave portion 232. In addition, by providing two or more inner concave portions 232, the volume of the ablation needle 230a can be further reduced, thereby further increasing the ablation area E.

[0119] Of course, the ablation needle in the first and second embodiments may also be provided with an inner recess, which may play the same role.

[0120] Embodiment five:

[0121] See also Fig.23 , Embodiment 5 of the present invention provides an ablation system 100, which includes the ablation device 10 of one of the above embodiments 1 to 4; and also includes an energy generating device 20, which is electrically connected to the ablation device 10 to provide energy for the ablation device 10. It can be seen from the above embodiments that the ablation device 10 includes an ablation needle assembly 3, and the distal end of the ablation needle assembly 3 includes an ablation needle 130 as a positive electrode or a negative electrode and an ablation needle 140 as a negative electrode or a positive electrode, wherein the ablation needle 130 and the ablation needle 140 are both connected to the energy generating device 20; the ablation needle assembly 3 enters the ventricular septum tissue by puncturing the endocardium through a catheter, and then the energy generating device 20 provides energy to the ablation needle 130 and the ablation needle 140 to ablate the ventricular septum tissue.

[0122] Embodiment six:

[0123] See also Fig.24The sixth embodiment of the present invention provides an ablation system 100a. Compared with the ablation system 100 in the fifth embodiment, the ablation system 100a is different in that the ablation system 100a further includes an irrigation device 30. The irrigation device 30 includes an irrigation pump and a liquid source. The liquid source provides an irrigation liquid for the ablation device 10 through the irrigation pump. The irrigation liquid is an electrolyte liquid. As mentioned above, the ablation needle 130 and the ablation needle 140 are respectively provided with an irrigation hole 131 and an irrigation hole 141.

[0124] In some embodiments, in order to meet the perfusion needs, the output capacity of the perfusion pump should at least meet 0.1-5.0mL / min. Since the perfusion pump needs to continuously supply liquid to the ablation needle 130 and the ablation needle 140 through the catheter during the perfusion ablation process, the catheter needs to have a certain size to avoid deformation and rupture due to the thin wall when the ablation needle 130 and the ablation needle 140 with a small aperture and a small inner diameter outputs the expected flow rate. Taking 5.0mL / min as an example, when the wall thickness is less than 0.5mm, the catheter is prone to deformation and rupture. When the wall thickness of the catheter is not less than 0.5mm, the catheter will not deform or rupture. Preferably, the catheter wall thickness is not less than 0.65mm, and more preferably not less than 1mm. The catheter can also be composed of two hoses of different sizes, for example, a first catheter section with an outer diameter of 2.5 mm and an inner diameter of 1.2 mm (single-side wall thickness of 0.65 mm), and a second catheter section with an outer diameter of 4.0 mm and an inner diameter of 0.8 mm (single-side wall thickness of 1.6 mm), as long as the wall thickness is not less than 0.5 mm.

[0125] The above is a preferred embodiment of the present invention. It should be pointed out that a person skilled in the art can make several improvements and modifications without departing from the principle of the present invention. These improvements and modifications are also considered to be within the scope of protection of the present invention.

Claims

1. A PFA ablation device, characterized in that: It includes an ablation needle assembly and a delivery assembly; the delivery assembly includes an adjustable bend catheter, the adjustable bend catheter includes at least two inner cavities, the ablation needle assembly includes at least one ablation unit, each of the ablation units includes a first ablation needle and a second ablation needle with a polarity opposite to that of the first ablation needle, the first ablation needle and the second ablation needle are respectively movably arranged in one of the inner cavities; after the first ablation needle and the second ablation needle extend out of the distal opening of the adjustable bend catheter, the distance between the corresponding extended parts of the first ablation needle and the second ablation needle in the radial direction of the adjustable bend catheter gradually increases from near to far.

2. The PFA ablation device according to claim 1, characterized in that: A first angle is formed between the first ablation needle and the axial direction of the adjustable bend catheter, and in the radial direction of the adjustable bend catheter, the first ablation needle extends in a direction away from the second ablation needle.

3. The PFA ablation device according to claim 2, characterized in that: The first angle is defined between the distal end of the first ablation needle and the rest of the first ablation needle, or between the central axis of the distal opening and the central axis of the adjustable bend catheter; the first angle ranges from 10° to 80°.

4. The PFA ablation device according to claim 1, characterized in that: When the second ablation needle extends out of the distal opening of the adjustable bend catheter, a second angle is formed between the second ablation needle and the axial direction of the adjustable bend catheter, and the second ablation needle extends in a direction away from the first ablation needle.

5. The PFA ablation device according to claim 1, characterized in that: The distal end of the first ablation needle has a curved portion extending away from the central axis of the adjustable bend catheter. After the first ablation needle extends out of the distal opening of the adjustable bend catheter, the needle tip of the first ablation needle deviates from the central axis of the adjustable bend catheter.

6. The PFA ablation device according to claim 1, characterized in that: The distal end of the second ablation needle has a curved portion extending away from the central axis of the adjustable bend catheter. After the second ablation needle extends out of the distal opening of the adjustable bend catheter, the needle tip of the second ablation needle deviates from the central axis of the adjustable bend catheter.

7. The PFA ablation device according to any one of claims 1 to 6, characterized in that: The distal end portion of the first ablation needle is provided with a first inner recessed portion recessed toward the inside of the first ablation needle.

8. The PFA ablation device according to any one of claims 1 to 6, characterized in that: The distal end portion of the second ablation needle is provided with a second inner recessed portion recessed toward the inside of the second ablation needle.

9. The PFA ablation device according to claim 1, characterized in that: The first ablation needle and / or the second ablation needle has an inner cavity, and at least one perfusion hole is opened at the distal end of the first ablation needle and / or the second ablation needle, and the perfusion hole is configured as an outlet of the inner cavity.

10. The PFA ablation device according to claim 1, characterized in that: The first ablation needle and / or the second ablation needle comprises a needle tip, and the needle tip comprises a first blade surface, and the first blade surface forms a third angle with the axial direction of the first ablation needle and / or the second ablation needle.

11. The PFA ablation device according to claim 10, characterized in that: The needle tip further includes two second blade surfaces, which are symmetrically arranged; the second blade surfaces and the first blade surfaces are located in different planes, and the second blade surfaces have a fourth angle with the axial direction of the first ablation needle.

12. An ablation system, characterized in that: It comprises the PFA ablation device of any one of claims 1 to 10 and an energy generating device, wherein the energy generating device is electrically connected to the first ablation needle and the second ablation needle of the PFA ablation device to provide energy for the PFA ablation device.

13. The ablation system according to claim 12, characterized in that: The ablation system also includes an irrigation device, which includes an irrigation pump and a liquid source. The liquid source provides irrigation liquid to the PFA ablation device through the irrigation pump. After the irrigation device injects electrolyte liquid into the inner cavity, the electrolyte liquid can flow out from the irrigation hole. When the electrolyte liquid flows in the inner cavity, it has a Reynolds number not higher than 1000.

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