Single-needle bipolar PFA ablation device and system

Abstract

The invention provides a single-needle bipolar PFA ablation device. The single-needle bipolar PFA ablation device comprises an ablation needle main body and a handle, the near end of the ablation needle main body is connected with energy generation equipment through the handle, the first insulating layer is located between the first electrode and the second electrode, and the polarity of the first electrode is opposite to that of the second electrode; the first electrode and the second electrode are used for releasing PFA ablation energy to tissues; wherein the average outer diameter of the first insulating layer is smaller than the average outer diameter of the first electrode and the second electrode. Through the arrangement, the first insulating layer is sunken towards the direction close to the central axis of the ablation needle main body relative to the first electrode and the second electrode, so that the ablation range of the PFA ablation device can be increased.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a single-needle bipolar 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 single-needle bipolar PFA ablation needle, wherein a positive electrode 11 and a negative electrode 13 are spaced apart at the distal end of the ablation needle, and the proximal end of the ablation needle is connected to an ablation device that provides energy. After the ablation device provides ablation energy to the ablation needle, discharge occurs between the positive electrode 11 and the negative electrode 13 to break down the myocardial cells located between the above two electrodes and form irreversible electroporation (IRE), thereby completing PFA ablation.

[0004] An insulating layer 12 is provided between the two electrodes to avoid direct electrical connection between the two electrodes, and the average outer diameter of the insulating layer 12 is substantially the same as the average outer diameter of the two electrodes; during PFA ablation, the closer to the two electrodes, the greater the electric field strength, and the farther away from the two electrodes, the smaller the electric field strength. After PFA ablation, the ablated tissue forms a dumbbell-shaped ablation area A with large sides and a small middle. Part of the tissue 14 outside the ablation area A and close to the insulating layer 12 is difficult to form irreversible electroporation, resulting in the part of the tissue 14 being difficult to ablate and a smaller ablation area. Summary of the invention

[0005] The technical problem to be solved by the present invention is to overcome the defects of the above-mentioned prior art and provide a single-needle bipolar PFA ablation device and system which can increase the ablation range and improve the ablation efficiency.

[0006] The technical solution of the present invention is to provide a single-needle bipolar PFA ablation device having the following structure: It includes an ablation needle body and a handle; the proximal end of the ablation needle body is connected to an energy generating device through the handle, and the distal end of the ablation needle body is provided with a first electrode, the first electrode is provided with a first insulating layer, and the first insulating layer is provided with a second electrode; the first insulating layer is located between the first electrode and the second electrode, and the polarity of the first electrode is opposite to that of the second electrode; the first electrode and the second electrode are used to release PFA ablation energy to tissue; wherein the average outer diameter of the first insulating layer is smaller than the average outer diameter of the first electrode and the second electrode at the same time.

[0007] Preferably, the outer diameter of the first insulating layer decreases first and then increases from the proximal end to the distal end, so that a concave portion is formed in the middle of the first insulating layer, and the concave portion is recessed toward the central axis of the ablation needle body relative to the first electrode and the second electrode.

[0008] Preferably, the handle is provided with a knob and at least one interface, the knob is used to adjust the relative position of the first electrode and the first insulating layer; the interface is used to connect with the energy generating device so that the energy generating device can provide ablation energy to the first electrode and the second electrode.

[0009] Preferably, a first angle is formed between the distal end portion of the ablation needle body and the axial direction of the ablation needle body, and the first angle is 10°-150°.

[0010] Preferably, the ablation needle body comprises a needle tip, the needle tip comprises a first blade surface, and the first blade surface forms a second angle with the axial direction of the ablation needle body.

[0011] Preferably, 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 third angle with the axial direction of the ablation needle.

[0012] 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 electrode of the PFA ablation device to provide energy for the PFA ablation device.

[0013] After the first electrode and the second electrode of the PFA ablation device and system of the present invention reach the target position, the energy generating device is started to provide ablation energy to the first electrode and the second electrode, and the tissue around the first electrode and the second electrode is ablated; the first insulating layer is located between the first electrode and the second electrode, and the average outer diameter of the first insulating layer is set to be smaller than the average outer diameter of the first electrode and the second electrode, so that the first insulating layer is recessed relative to the first electrode and the second electrode toward the central axis of the ablation needle body, so that more tissue can be located in the ablation area of ​​the PFA ablation device, thereby increasing the ablation range of the PFA ablation device; a first angle is set between the distal end of the ablation needle body and the axial direction of the ablation needle body, so that the straight-line distance between the tissue around the first insulating layer 120b and the first electrode 110 and the second electrode 130 is shortened, so that this part of the tissue is more likely to produce irreversible electroporation during PFA ablation, thereby enhancing the ablation effect on this part of the tissue and improving the ablation efficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] 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.

[0015] Figure 1 It is a schematic diagram of the structure of a PFA single-needle bipolar ablation needle in the prior art; Figure 2 is a schematic structural diagram of an ablation device provided in Embodiment 1 of the present invention; Figure 3 yes Figure 2 A schematic diagram of a partially enlarged structure of a distal portion of an ablation device; Figure 4 yes Figure 3 Schematic diagram of the ablation area where the ablation device is withdrawn from the tissue after ablation; Figure 5 is a schematic structural diagram of an ablation device according to another embodiment; Figure 6 yes Figure 5 Schematic diagram of the ablation area where the ablation device is withdrawn from the tissue after ablation; Figure 7 is a schematic diagram of a bevel needle tip; Figure 8 for Figure 7 Schematic diagram of another perspective of the needle tip; Fig. 9A schematic diagram of a needle tip having a first edge surface and a second edge surface; Fig.10 for Fig. 9 Schematic diagram of another perspective of the needle tip; Fig.11 is a structural schematic diagram of an ablation system provided by Embodiment 2 of the present invention; DETAILED DESCRIPTION

[0016] 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.

[0017] 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.

[0018] 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.

[0019] 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 center and the proximal center of the medical device. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0020] It should also be noted that the X direction mentioned in the text is the axial direction of the ablation needle body, the Y direction is the radial direction of the ablation needle body, and the XY plane refers to the plane where the X direction and the Y direction are located. Example

[0021] like Figure 2 , 11As shown, the first embodiment of the present invention provides a single-needle bipolar PFA ablation device 10, which includes an ablation needle body and a handle 150; the proximal end of the ablation needle body is connected to the energy generating device 20 (see Fig.11 As shown), the distal end of the ablation needle body is provided with a first electrode 110, a first insulating layer 120 is partially sleeved on the first electrode 110, and a second electrode 130 is sleeved on the first insulating layer 120; the first insulating layer 120 is located between the first electrode 110 and the second electrode 130, and the polarity of the first electrode 110 is opposite to that of the second electrode 130; the first electrode 110 and the second electrode 130 are used to release PFA ablation energy to the tissue; wherein the average outer diameter of the first insulating layer 120 is smaller than the average outer diameter of the first electrode 110 and the second electrode 130.

[0022] Specifically, Figure 2 As shown, the proximal end of the first insulating layer 120 is an end close to the handle 150, and the distal end is an end away from the handle 150. The first insulating layer 120 is located between the first electrode 110 and the second electrode 130, and the first insulating layer 120 isolates the above two electrodes to avoid direct connection between the above two electrodes. The outer diameter of the first electrode 110 is consistent along the X direction, and the outer diameter of the first insulating layer 120 decreases first and then increases from the proximal end to the distal end in the X direction, and the outer diameter of the second electrode 130 is consistent along the X direction, wherein the average outer diameter of the first insulating layer 120 is smaller than the average outer diameter of the first electrode 110 and the second electrode 130, and the outer diameter of the first electrode 110 is the same as the outer diameter of the second electrode 130 or the outer diameter of the first electrode 110 is slightly smaller than the outer diameter of the second electrode 130.

[0023] Through the above arrangement, a concave portion 121 is formed in the middle of the first insulating layer 120. The concave portion 121 is concave relative to the first electrode 110 and the second electrode 130 toward the central axis of the ablation needle body. When the distal end of the ablation needle body is located in the tissue, part of the tissue surrounding the first insulating layer 120 is located in the concave portion 121, so that the part of the tissue is closer to the central axis of the ablation needle body relative to the first electrode 110 and the second electrode 130. When the energy generating device 20 provides PFA ablation energy to the ablation device 10, there is a voltage difference between the first electrode 110 (positive or negative) and the second electrode 130 (negative or positive), and a pulse discharge occurs between the first electrode 110 and the second electrode 130; since the part of the tissue is located in the concave portion 121 and the ablation area of ​​the PFA ablation device, the part of the tissue will also be affected by the above-mentioned PFA ablation energy and produce irreversible electroporation. After ablation, the projection of the ablated tissue on the XY plane is the ablation area B, as shown in FIG. Figure 3 As shown; after the PFA ablation device 10 is withdrawn from the tissue, the tissue in the ablation area B loses the squeezing effect of the PFA ablation device 10, and the projection of the ablated tissue on the XY plane is the ablation area C, as shown Figure 4 As shown. Among them, due to Figure 1 The insulating layer 12 in the PFA ablation device 10 has no recessed portion, so the volume is relatively large; while the first insulating layer 120 of the PFA ablation device 10 is provided with a recessed portion 121, so the volume is relatively small; when the ablation areas that can be ablated by the single-needle bipolar ablation device are the same and the ablation device needs to occupy a certain volume of the ablation area, the smaller the volume of the ablation device, the more tissue can be ablated, so the ablation area C is larger than the ablation area A.

[0024] It can be seen that by providing the inner recess 121, more tissues close to the first insulating layer 120 and equivalent to the size of the inner recess 121 can be ablated by the PFA ablation device 10, thereby increasing the ablation range of the PFA ablation device 10 and improving the ablation efficiency.

[0025] In some embodiments, at least two inner recesses 121 are provided on the first insulating layer 120, and two adjacent inner recesses 121 are spaced apart in a single spiral manner along the direction of the central axis of the first insulating layer 120. Specifically, on a radial section perpendicular to the central axis of the first insulating layer 120, there is only one inner recess 121 in the same radial section, and two inner recesses 121 adjacent along the X direction are staggered in the Z direction (i.e., the circumferential direction of the ablation needle body), and two or more inner recesses 121 arranged in this regular pattern continuously form a single spiral structure H1, and at this time, the two or more inner recesses 121 are evenly distributed in the X direction. Through the above arrangement, on the radial cross section of the first insulating layer 120, it is ensured that there is only one inner concave portion 121 in the same radial cross section, avoiding the situation where the strength of the ablation needle body is reduced due to multiple inner concave portions 121 distributed on the same radial cross section, thereby ensuring the strength and structural stability of the ablation needle body itself, so that the ablation needle body will not be greatly reduced in structural strength and breakage of the ablation needle body during the process of passing through the blood vessel and adjusting the bend due to the existence of the inner concave portion 121. In addition, by providing two or more inner concave portions 121, the volume of the first insulating layer 120 can be further reduced, thereby further increasing the ablation area D.

[0026] like Figure 2 As shown, the handle 150 is provided with a knob 151 and at least one interface 152, the knob 151 is used to adjust the first electrode 110 or the first insulating layer 120 or the second electrode 130 or the second insulating layer 140, and the interface 152 is used to connect with the energy generating device 20 so that the energy generating device 20 can provide ablation energy to the first electrode 110 and the second electrode 130.

[0027] In some embodiments, the first insulating layer 120, the second electrode 130 and the second insulating layer 140 are all fixedly arranged, and the length of the first electrode 110 extending out of the first insulating layer 120 can be adjusted by operating the knob 151; in some embodiments, the first electrode 110, the second electrode 130 and the second insulating layer 140 are all fixedly arranged, and the length of the first insulating layer 120 covering the first electrode 110 can be adjusted by operating the knob 151; in some embodiments, the first electrode 110, the first insulating layer 120 and the second insulating layer 140 are all fixedly arranged, and the length of the second electrode 130 extending out of the second insulating layer 140 can be adjusted by operating the knob 151; in some embodiments, the first electrode 110, the first insulating layer 120 and the second electrode 130 are all fixedly arranged, and the length of the second insulating layer 140 covering the second electrode 130 can be adjusted by operating the knob 151.

[0028] like Figure 5As shown, in some embodiments, in a natural state, an angle α is formed between the distal end of the ablation needle body and the X direction. Specifically, the ablation needle body is bent at the connection between the first insulating layer 120b and the second electrode 130 and has an angle α with the X direction, or the ablation needle body is bent at the middle position of the first insulating layer 120b and has an angle α with the X direction. Through the above arrangement, the straight-line distance between the first electrode 110 and the second electrode 130 is shortened, so that the straight-line distance between the tissue located around the first insulating layer 120b and the first electrode 110 and the second electrode 130 is also shortened, making it easier for this part of the tissue to produce irreversible electroporation during PFA ablation, thereby enhancing the ablation effect on this part of the tissue and improving the ablation efficiency; after ablation using the ablation needle body, the projection of the ablated tissue on the XY plane is the ablation area D, as shown in FIG. Figure 6 Generally, the angle α is 10°-150°, preferably the angle α is 30°-120°, and more preferably the angle α is 60°-90°.

[0029] The ablation needle body is preferably made of a nickel-titanium alloy tube with superelastic properties, so that the ablation needle body has elasticity. The ablation needle body 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 a catheter; during the catheter intervention, in order to align the ablation needle body with the puncture point of the ventricular septum, the ablation needle body needs to be bent multiple times under the drive of the catheter, so the ablation needle body has a certain degree of flexibility and elasticity, and can smoothly pass through the winding blood vessels without being damaged and losing elasticity and 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 external force, and return to its original shape after the external force is unloaded. It can be suitable for the application scenario of this device. At the same time, because 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 first electrode 110 serves as a part of the ablation needle body.

[0030] In a possible embodiment, one or both of the first electrode 110 and the second electrode 130 are metal electrodes of a ring, sheet or other structure made by external processing, fixed to the ablation needle body or the first insulating layer 120 by means including but not limited to bonding, crimping, welding or the like, and connected to the energy generating device 20 by a wire to achieve electrical conduction. The metal electrode is preferably made of metal materials such as gold, silver, platinum-based alloy, cobalt-chromium alloy, tantalum or the like.

[0031] In other embodiments, the outer surface of the ablation needle body may be attached with a first insulating layer 120, and the exposed area of ​​the distal end of the ablation needle body that is not covered by the first insulating layer 120 serves as the first electrode 110 for releasing ablation energy. Then, the second electrode 130 is sleeved on the first insulating layer 120, and at least part of the first insulating layer 120 is between the first electrode 110 and the second electrode 130 to avoid direct connection between the two; and the second insulating layer 140 is sleeved between the second electrode 130 and the handle 150.

[0032] The first insulating layer 120 / the second insulating layer 140 may be a layer of polymer material wrapped on the ablation needle body / the second electrode 130 by heat shrinking, or may be directly sleeved on the outside of the ablation needle body / the second electrode 130, or may be attached to the outside of the ablation needle body / the second electrode 130 by a coating process. The outer surfaces of the first insulating layer 120 and the second insulating layer 140 should have a low friction coefficient and a high insulation resistance. The low friction coefficient can give the ablation needle body good lubricity and pushing performance, and the high insulation resistance can make the first insulating layer 120 and the second insulating layer 140 still maintain excellent dielectric insulation without being broken down under the action of high-frequency pulses.

[0033] When the first insulating layer 120 / the second insulating layer 140 is wrapped on the outside of the ablation needle body / the second electrode 130 by heat shrinking, the insulating material is preferably PET (polyethylene terephthalate), PTFE (polytetrafluoroethylene), FEP (fluorinated ethylene propylene) and other materials. When the first insulating layer 120 / the second insulating layer 140 is fixed on the outside of the ablation needle body / the second electrode 130 by sleeve installation, the first insulating layer 120 / the second insulating layer 140 is preferably made of PEEK (polyetheretherketone), PI (polyimide) and other materials. When the first insulating layer 120 / the second insulating layer 140 is adhered to the outside of the ablation needle body / the second electrode 130 by a coating process, the insulating material is preferably Parylene (polyparaxylene).

[0034] In some other possible embodiments, the ablation needle body may also be made of a polymer material. In this case, the first electrode 110 should be an independent component with good electrical conductivity fixed to the ablation needle body. Specifically, the first electrode 110 should be one or more ring-shaped metal electrodes, which are fixed to the distal end of the ablation needle body by means including but not limited to bonding, welding, crimping, welding, etc., and are electrically connected to an external energy generating device through a wire. The ring-shaped 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 confirm the position of the first electrode 110.

[0035] When the ablation needle body is made of polymer material, the polymer material 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 needle body has excellent pushing performance during the forward and backward movement along the central axis of the adjustable curved catheter, the material should have a low surface friction coefficient, which can reduce the pushing resistance of the ablation needle body in the lumen of the adjustable curved catheter 120. At the same time, in order to ensure the insulation of the ablation needle body, the material should have excellent dielectric insulation, high insulation resistance, small dielectric constant, and high voltage resistance. Therefore, the ablation needle body preferably uses polymer materials such as polypropylene PP, high-density polyethylene HDPE, and polytetrafluoroethylene PTFE.

[0036] In some possible embodiments, the first insulating layer 120 and the second insulating layer 140 contain materials with ultrasound absorption. Through the above configuration, under ultrasound, the two insulating layers have lower echoes, while the first electrode 110 and the second electrode 130 have higher echoes. Therefore, under ultrasound imaging, the operator can easily identify the positions of the first electrode 110 and the second electrode 130, which can avoid prolonged operation time due to difficulty in identifying the positions of the first electrode 110 and the second electrode 130. At the same time, it can also avoid incorrect ablation position caused by incorrect identification of the positions of the first electrode 110 and the second electrode 130, which can cause adverse effects on patients.

[0037] like Figure 7-8 The ablation needle body has a needle tip 112, which is a closed and sharp tip structure. Its shape includes but is not limited to a cone, a triangular pyramid, a quadrangular pyramid, a single-bevel cutting edge, etc. The shape of the needle tip 112 can provide the ablation needle body with a sufficiently sharp needle tip 112 structure, so that it can pierce the endocardial or epicardial tissue with a smaller puncture force, thereby smoothly entering the ventricular septum myocardial tissue.

[0038] The ablation needle body is integrally formed by laser cutting, grinding, wire cutting and other processing methods. The needle tip 112 is a beveled structure and is provided with a first blade surface 1121. The first blade surface 1121 forms a first angle β with the axial direction (i.e., X direction) of the ablation needle body. The above arrangement can enhance the sharpness of the needle tip 112, 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 first angle β is 10°-45°, preferably the first angle β is 15°-40°, and more preferably the first angle β is 20°-35°.

[0039] In some embodiments, Figure 9-10As shown, the distal end of the first blade surface 1121 is also provided with two second blade surfaces 1122 symmetrical with respect to the first blade surface 1121, and the distal ends of the second blade surfaces 1122 meet at the most distal end of the first blade surface 1121, and each second blade surface 1122 forms a second angle γ with the axial direction of the ablation needle body, so that the first blade surface 1121 and the second blade surface 1122 are located in different planes. Through the above arrangement, during the puncture of the needle tip 112, the two second blade surfaces 1122 cut tissues on their respective planes, and the first blade surface 1121 cuts tissues on another plane, which can further enhance the sharpness of the needle tip 112 and enable the needle tip 112 to puncture tissues more quickly. The second angle γ is 10-45°, preferably the second angle γ is 15°-40°, and more preferably the second angle γ is 20°-35°. In addition, the surface of the needle tip 112 may be coated with a layer of gold coating or other non-radio-transmissive coating materials, so as to enhance the visualization of the needle tip 112 under external imaging equipment.

[0040] In some embodiments, the needle tip 112 and the ablation needle body are split structures. The needle tip 112 is a separately processed needle head, and the distal end of the needle tip 112 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 body by means including but not limited to bonding, welding, etc. In this embodiment, the ablation needle body 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 112 and the first electrode 110 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 body during ablation. Example

[0041] See also Fig.11 , Embodiment 2 of the present invention discloses an ablation system 2, which includes the ablation device 10 in the above-mentioned embodiment 1; 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-mentioned embodiment that the ablation device 10 includes an ablation needle body, and the distal end of the ablation needle body includes a needle tip 112, a first electrode 110, and a second electrode 130; the ablation needle body enters the ventricular septal tissue through the apex by puncturing the epicardium, and then the energy generating device 20 provides energy to the first electrode 110 and the second electrode 130 to ablate the ventricular septal tissue.

[0042] The above description is only a specific implementation mode of the present invention, but the protection scope of the present invention is not limited thereto. Any changes or substitutions that can be easily thought of by any technician familiar with the technical field within the technical scope disclosed by the present invention should be included in the protection scope of the present invention. Therefore, the protection scope of the present invention should be based on the protection scope of the claims.

Claims

1. A single-needle bipolar PFA ablation device, characterized in that: It includes an ablation needle body and a handle; the proximal end of the ablation needle body is connected to an energy generating device through the handle, and the distal end of the ablation needle body is provided with a first electrode, the first electrode is provided with a first insulating layer, and the first insulating layer is provided with a second electrode; the first insulating layer is located between the first electrode and the second electrode, and the polarity of the first electrode is opposite to that of the second electrode; the first electrode and the second electrode are used to release PFA ablation energy to tissue; wherein the average outer diameter of the first insulating layer is smaller than the average outer diameter of the first electrode and the second electrode at the same time.

2. A single-needle bipolar PFA ablation device according to claim 1, characterized in that: The outer diameter of the first insulating layer decreases first and then increases from the proximal end to the distal end, so that a concave portion is formed in the middle of the first insulating layer, and the concave portion is recessed toward the central axis of the ablation needle body relative to the first electrode and the second electrode.

3. A single-needle bipolar PFA ablation device according to claim 1, characterized in that: The handle is provided with a knob and at least one interface, the knob is used to adjust the relative position of the first electrode and the first insulating layer; the interface is used to connect with the energy generating device so that the energy generating device can provide ablation energy for the first electrode and the second electrode.

4. A single-needle bipolar PFA ablation device according to claim 1, characterized in that: A first angle is formed between the distal end portion of the ablation needle body and the axial direction of the ablation needle body, and the first angle is 10°-150°.

5. A single-needle bipolar PFA ablation device according to claim 1, characterized in that: The ablation needle body includes a needle tip, and the needle tip includes a first blade surface. The first blade surface has a second angle with the axial direction of the ablation needle body.

6. A single-needle bipolar PFA ablation device according to claim 5, 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 third angle with the axial direction of the ablation needle.

7. An ablation system, characterized in that: It comprises the PFA ablation device according to any one of claims 1 to 6 and an energy generating device, wherein the energy generating device is electrically connected to the first electrode of the PFA ablation device to provide energy for the PFA ablation device.

Images