A surgical ablation catheter

Abstract

This invention belongs to the field of medical device technology and discloses a surgical ablation catheter, including a catheter body, at least one ablation electrode, and a shaping tube. The catheter body includes an ablation segment disposed at the distal end, and has a lumen within the catheter body. Along an axial direction perpendicular to the catheter body, the ablation segment has an arc-shaped cross-section with a circular arc side and a straight side. The ablation segment has a corresponding fitting portion on the straight side, which extends along a plane and is used to abut against the target tissue. The ablation electrode is disposed outside the fitting portion and extends along the fitting portion. The shaping tube passes through the lumen and extends along the axial direction of the catheter body. The shaping tube can undergo plastic bending to maintain the corresponding bending posture of the catheter body. The surgical ablation catheter of this invention increases the effective coupling area between the ablation electrode and the target tissue, improves the consistency of ablation depth, reduces the risk of slippage and detachment, and improves the stability of the surgical ablation catheter. It can also be manually bent to adapt to target tissue surfaces with different curvatures.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a surgical ablation catheter. Background Technology

[0002] Pulsed Field Ablation (PFA) is a non-thermal ablation technique based on the principle of irreversible electroporation. Surgical PFA ablation catheters are specialized surgical instruments that perform pulsed field ablation via the epicardial pathway. Through electrodes at the distal end of the catheter, high-voltage short-duration electrical pulses are released into the target myocardial tissue, inducing irreversible perforation of the myocardial cell membrane, thereby selectively causing apoptosis of the target myocardial cells and blocking abnormal electrical signal conduction pathways. It has advantages such as high myocardial tissue selectivity, non-thermal damage, and no risk of steam bursting, and has become an important direction for the development of surgical treatment of arrhythmias.

[0003] Most existing surgical ablation catheters use a circular cross-section, primarily due to the mature manufacturing process and the continuation of traditional interventional catheter design principles. However, the circular cross-section only forms linear or minimal contact with the epicardial tissue, resulting in insufficient effective electrode coupling area, uneven electric field distribution, and poor consistency in ablation depth. Furthermore, the epicardial surface is constantly subject to dynamic displacement due to the periodic contraction and relaxation of the myocardium, making the catheter prone to slippage during cardiac pulsation. Existing surgical PFA ablation catheters rely solely on their own weight or pressure applied by the operator to maintain contact with the target tissue, making them highly susceptible to target tissue detachment during high-voltage pulsed discharge. This interruption of the ablation line ultimately affects the stability of the ablation effect and the surgical efficacy.

[0004] Furthermore, surgical ablation catheters need to be axially aligned with the surface of the heart (epidermal surface) for ablation. Significant individual differences exist in the anatomical morphology of different parts of the heart, and target sites such as the pulmonary vein vestibule, the root of the left atrial appendage, and the atrial wall have different curvatures and spatial orientations. Current surgical ablation catheters often use adjustable wires with control handles for temporary random bending or use shape-memory alloys to create curved tubes. Controlling the handles with both hands is unsuitable for flexible adjustments under direct surgical visualization, while the shape-memory alloy method allows for flexible adjustments based on actual anatomical morphology, resulting in poor adaptability. Summary of the Invention

[0005] The purpose of this invention is to provide a surgical ablation catheter that can solve the problems caused by the existing circular cross-section tubes, such as the small contact area with the target tissue, the easy detachment of the target tissue, which leads to the interruption of the continuity of the ablation line, and the difficulty in adapting to the curvature changes of the target tissue in different locations.

[0006] To achieve this objective, the present invention adopts the following technical solution: A surgical ablation catheter is provided, comprising: The catheter body includes an ablation segment disposed at the distal end. The catheter body has a lumen along an axial direction perpendicular to the catheter body. The cross-sectional shape of the ablation segment is arc-shaped, with an arc side and a straight side. The ablation segment has an abutment portion corresponding to the straight side. The abutment portion extends along a plane and is used to abut against the target tissue. At least one ablation electrode is disposed on the outside of the bonding portion and extends along the bonding portion; A shaped tube is inserted into the lumen and extends axially along the main body of the conduit. The shaped tube is capable of plastic bending so that the main body of the conduit maintains a corresponding bending posture.

[0007] In one embodiment, the fitting portion has a through-hole for adsorption, and the surgical ablation catheter also includes a negative pressure component disposed within the lumen. The proximal end of the negative pressure component is connected to a negative pressure generating device, and the distal end is in fluid communication with the adsorption hole. The negative pressure component is used to provide negative pressure to the adsorption hole so that the fitting portion adheres to the target tissue.

[0008] In one embodiment, the fitting portion has a plurality of adsorption holes, which are spaced apart along the axial direction of the catheter body.

[0009] In one embodiment, the surgical ablation catheter includes a plurality of ablation electrodes, which are spaced apart along the axial direction of the catheter body, and the ablation electrodes and the suction holes are staggered.

[0010] In one embodiment, the fitting portion is provided with sealing protrusions on both radially adjacent edges, and the adsorption hole is located between two of the sealing protrusions.

[0011] In one embodiment, along a direction perpendicular to the bonding portion, the height of the ablation electrode is not less than the height of the sealing protrusion; and / or, The surgical ablation catheter also includes two sealing strips, the length of which extends along the axial direction of the catheter body. The sealing strips are attached to the outer surface of the fitting portion, and the two sealing strips are spaced apart on both radially adjacent edges of the fitting portion.

[0012] In one embodiment, the shaped tube comprises at least one solid metal wire and / or the shaped tube comprises at least one hollow metal tube; and / or, The main body of the catheter is made of flexible plastic, and the shaped tube is made of malleable metal.

[0013] In one embodiment, the shaped tube comprises a hollow metal tube having a receiving cavity extending along its own axial direction.

[0014] The material of the shaped tube is aluminum, aluminum alloy, stainless steel, copper, or copper alloy.

[0015] In one embodiment, the length of the straight side is L1, and the diameter of the arc side is L2, where 0.6×L2≤L1≤0.85×L2.

[0016] The beneficial effects of this invention are: The surgical ablation catheter provided by this invention includes a catheter body and at least one ablation electrode. The catheter body includes an ablation segment disposed at its distal end and has a lumen within it. Along an axial direction perpendicular to the catheter body, the ablation segment has an arc-shaped cross-section with a circular arc side and a straight side. The ablation segment has a corresponding fitting portion on the straight side, extending along a plane and used to abut against the target tissue. The ablation electrode is disposed outside the fitting portion and extends along it. The ablation electrode is electrically connected to an external pulsed electric field generator via an insulated wire passing through the lumen, used to apply a high-voltage pulsed electric field to the target tissue, achieving irreversible electroporation ablation. A shaping tube is inserted into the lumen and extends along the axial direction of the catheter body. The shaping tube is capable of plastic bending to maintain a corresponding bending posture of the catheter body.

[0017] With the above configuration, the surgical ablation catheter employs an ablation segment with an arc-shaped cross-section. Firstly, during the ablation process, the ablation segment abuts against the target tissue with its corresponding straight side, transforming the traditional line contact between a circular tube and the tissue into a surface contact, effectively increasing the effective coupling area between the ablation electrode and the target tissue. Secondly, the straight side of the ablation segment closely adheres to the target tissue plane, eliminating the wedge-shaped gap naturally present between the arc surface and the flat tissue, reducing current shunting caused by blood seeping into the wedge-shaped gap, ensuring that the pulsed electric field energy effectively acts on the target tissue, and improving ablation effectiveness and energy utilization. Furthermore, the ablation electrode acts uniformly on the target tissue along the straight side of the ablation segment, and the pulsed electric field is uniformly distributed along the target tissue plane during discharge, avoiding the problem of rapid radial attenuation of the electric field intensity caused by arc-shaped surface contact, significantly improving the consistency of the ablation depth. On the other hand, surface contact increases the static friction and lateral constraint between the ablation segment and the target tissue, which can better adapt to the dynamic tissue displacement caused by myocardial contraction and relaxation, reduce the risk of slippage and detachment of the surgical ablation catheter during cardiac pulsation and pulse discharge, effectively ensure the accuracy of the ablation site and the continuity of the ablation line, and improve the stability of the surgical ablation catheter.

[0018] In addition, the operator can shape the tubing into the desired form, such as a straight line, arc, S-shape, or L-shape, by simple manual bending operations before or during the procedure, based on the anatomical morphology of the target site. This deformation of the tubing causes the main body of the catheter to deform, ensuring the overall curvature of the surgical ablation catheter matches the curvature of different target sites (such as the large curvature of the atrial wall). This eliminates the need for a fixed template, and the bent posture of the catheter body is permanently maintained after shaping, without automatically reverting to its original position. It is unaffected by body temperature or the physiological environment, meeting the requirements for stable and close-fitting ablation in complex anatomical situations. Furthermore, since the bending and shaping of the tubing occurs preoperatively, it does not interfere with intraoperative hand manipulation, making it convenient to use. Attached Figure Description

[0019] Figure 1 This is a schematic diagram of the structure of the surgical ablation catheter described in an embodiment of the present invention; Figure 2 yes Figure 1 A magnified view of part A in the middle; Figure 3 This is a cross-sectional view of the surgical ablation catheter described in an embodiment of the present invention.

[0020] In the picture: 1. Catheter body; 11. Ablation section; 12. Lumen; 13. Adhesion part; 131. Adsorption hole; 132. Sealing protrusion; 133. Infusion hole; 14. Arc side; 15. Straight side; 16. Shaped tube; 2. Ablation electrode; 21. Insulated wire; 3. Negative pressure assembly; 4. Handle. Detailed Implementation

[0021] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0022] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance. The terms "first position" and "second position" refer to two different positions. Furthermore, "above," "on top of," and "over" the first feature in relation to the second feature includes the first feature directly above and diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "under," and "below" the first feature in relation to the second feature includes the first feature directly below and diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0023] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0024] Embodiments of the present invention are described in detail below. Examples of these embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present invention, and should not be construed as limiting the present invention.

[0025] The technical solution of the present invention will be further described below with reference to the accompanying drawings and specific embodiments.

[0026] like Figures 1 to 3As shown, this invention provides a surgical ablation catheter, comprising a catheter body 1 and at least one ablation electrode 2. The catheter body 1 includes an ablation segment 11 disposed distally, and a lumen 12 within the catheter body 1. Along an axial direction perpendicular to the catheter body 1, the ablation segment 11 has an arc-shaped cross-section, with an arcuate side 14 and a straight side 15. The ablation segment 11 has a corresponding fitting portion 13 on the straight side 15, extending along a plane and used to abut against the target tissue. The ablation electrode 2 is disposed outside the fitting portion 13 and extends along it. The ablation electrode 2 is electrically connected to an external pulsed electric field generator via an insulated wire 21 passing through the lumen 12, for applying a high-voltage pulsed electric field to the target tissue to achieve irreversible electroporation ablation. A shaping tube 16 passes through the lumen 12 and extends along the axial direction of the catheter body 1. The shaping tube 16 is capable of plastic bending to maintain a corresponding bending posture of the catheter body 1.

[0027] With the above configuration, the surgical ablation catheter employs an ablation segment 11 with an arc-shaped cross-section. On one hand, during the ablation process, the ablation segment 11, with its corresponding flat side 15, abuts against the target tissue, transforming the traditional line contact between the circular tube and the tissue into surface contact, effectively increasing the effective coupling area between the ablation electrode 2 and the target tissue. The flat abutment 13 fits tightly against the target tissue plane, eliminating the wedge-shaped gap naturally present between the arc surface and the flat tissue, reducing current shunting caused by blood seeping into the wedge-shaped gap, ensuring that the pulsed electric field energy effectively acts on the target tissue, and improving ablation effectiveness and energy utilization. Furthermore, the ablation electrode 2 acts uniformly on the target tissue along the flat, extended abutment 13, and during discharge, the pulsed electric field is uniformly distributed along the target tissue plane, avoiding the problem of rapid radial attenuation of the electric field intensity caused by arc-shaped surface contact, significantly improving the consistency of the ablation depth. On the other hand, the increased surface contact increases the static friction and lateral constraint between the ablation segment 11 and the target tissue, which can better adapt to the dynamic tissue displacement caused by myocardial contraction and relaxation, reduce the risk of slippage and detachment of the surgical ablation catheter during cardiac pulsation and pulse discharge, effectively ensure the accuracy of the ablation site and the continuity of the ablation line, and improve the stability of the surgical ablation catheter.

[0028] In addition, the operator can shape the shaping tube 16 into the desired shape, such as a straight line, arc, S-shape, or L-shape, by simple manual bending operations before or during the procedure, based on the anatomical morphology of the target site. The deformation of the shaping tube 16 causes the catheter body 1 to deform, so that the overall curvature of the surgical ablation catheter matches the curvature of different target sites (such as the large curvature of the atrial wall). There is no need to rely on a fixed template. After shaping, the bending posture of the catheter body 1 is permanently maintained and will not automatically recover. It is not affected by body temperature or physiological environment, meeting the stable and close-fitting ablation requirements in complex anatomical situations. Moreover, the bending and shaping of the shaping tube 16 occurs before the procedure and will not affect the operation of both hands during the procedure, making it more convenient to use.

[0029] The ablation segment 11 has a length of 20mm to 120mm to meet the ablation area requirements of the target tissue. The proximal end of the catheter body 1 is a circular tube for easy sealing connection with the handle 4. A smooth end cap can be provided at the distal end of the catheter body 1 to prevent accidental tissue puncture during operation.

[0030] In one embodiment, the fitting portion 13 has a through suction hole 131. The surgical ablation catheter also includes a negative pressure component 3, which is disposed in the lumen 12. The proximal end of the negative pressure component 3 is connected to a negative pressure generating device, and the distal end is in fluid communication with the suction hole 131. The negative pressure component 3 is used to provide negative pressure to the suction hole 131 so that the fitting portion 13 fits the target tissue, effectively counteracting the displacement caused by myocardial pulsation. During the entire ablation and discharge process, the contact between the fitting portion 13 and the target tissue is maintained, further avoiding slippage and detachment of the surgical ablation catheter, reducing the risk of ablation failure and repeated discharge caused by detachment, and improving operational stability and ablation effect.

[0031] The specific structure and working principle of the negative pressure component 3 can be set with reference to existing technology, and will not be described in detail in this embodiment.

[0032] In one embodiment, the fitting part 13 has a plurality of adsorption holes 131, which are spaced apart along the axial direction of the catheter body 1. This allows for multi-point uniform adsorption within the axial range of the ablation section 11, ensuring that the fitting part 13 and the target tissue are tightly fitted along the entire axial direction. This eliminates local gaps in the fitting, further enhances the contact stability between the fitting part 13 and the target tissue, better counteracts the dynamic displacement caused by myocardial pulsation, and ensures the continuity of the ablation line and the uniformity of the ablation depth.

[0033] For example, the pore size of the adsorption pore 131 is 0.5 mm to 2 mm, the spacing between adjacent adsorption pores 131 is 3 mm to 8 mm, and the adsorption force provided by the adsorption pore 131 is approximately 0.5 N / cm. 2 ~1.5N / cm 2 The specific values ​​of the above parameters can be set according to clinical needs, and this embodiment does not impose any restrictions.

[0034] In one embodiment, the surgical ablation catheter includes multiple ablation electrodes 2, which are spaced apart along the axial direction of the catheter body 1, and the ablation electrodes 2 and the suction holes 131 are staggered. On the one hand, the negative pressure suction force can be evenly applied to the tissue area between each ablation electrode 2, causing the entire adhesive portion 13 to be flatly attached to the target tissue, avoiding local adhesion gaps and warping, and ensuring that each ablation electrode 2 forms a stable and effective contact with the target tissue, better counteracting myocardial pulsation displacement; on the other hand, the staggered arrangement avoids the suction holes 131 occupying the electrode layout space, ensuring the effective discharge area and axial continuity of the ablation electrodes 2, while eliminating adhesion gaps around the ablation electrodes 2, reducing current shunting caused by blood infiltration, and making the pulse electric field evenly distributed along the ablation line, improving the consistency of ablation depth and the stability of ablation effect.

[0035] In one embodiment, the surgical ablation catheter includes 8 to 16 platinum-iridium alloys, and at least two adsorption holes 131 are provided between two adjacent ablation electrodes 2. Through multi-point adsorption, the adsorption force of a single adsorption hole 131 can be reduced, avoiding damage to the target tissue due to excessive local negative pressure; at the same time, the adsorption force distribution between the ablation electrodes 2 is more uniform, ensuring that the fitting part 13 is flat and fitted, eliminating local fitting gaps, maintaining stable contact between the surgical ablation catheter and the target tissue, and improving the uniformity of ablation.

[0036] In one embodiment, the bonding portion 13 has sealing protrusions 132 on both radially adjacent edges, and the adsorption hole 131 is located between the two sealing protrusions 132. During negative pressure adsorption, the sealing protrusions 132 first abut against the target tissue, enclosing a closed negative pressure space, which can effectively prevent external blood from seeping in, improve the sealing performance of the adsorption hole 131, reduce negative pressure leakage, and ensure stable and long-lasting adsorption force; at the same time, it can further eliminate the bonding gap around the ablation electrode 2, reducing the current shunting caused by blood seepage.

[0037] Along the direction perpendicular to the bonding portion 13, the height of the ablation electrode 2 is not lower than the height of the sealing protrusion 132. The surface of the ablation electrode 2 protrudes slightly from the surface of the sealing protrusion 132 by about 0.1mm to 0.3mm, or the surface of the ablation electrode 2 is flush with the surface of the sealing protrusion 132. When the height of the ablation electrode 2 is not lower than the sealing protrusion 132, it can ensure effective direct contact between the ablation electrode 2 and the target tissue during the negative pressure adsorption bonding process, avoiding the sealing protrusion 132 blocking the ablation electrode 2 and causing it to be suspended, thus ensuring that the pulsed electric field energy is fully applied to the target tissue. The setting of the surface of the ablation electrode 2 protruding slightly by 0.1mm to 0.3mm allows the ablation electrode 2 to preferentially and tightly contact the target tissue, improving the consistency of the ablation depth.

[0038] In one embodiment, the ablation electrode 2 is a non-circular annular electrode. The cross-sectional shape of the ablation electrode 2 along the axis perpendicular to the catheter body 1 is arc-shaped. The ablation electrode 2 is sleeved on the ablation section 11 and is arranged around the sealing protrusion 132. The cross-sectional shape of the ablation electrode 2 is adapted to the cross-sectional shape of the ablation section 11. The surface of the ablation electrode 2 protrudes from the sealing protrusion 132.

[0039] In one embodiment, the surgical ablation catheter further includes two sealing strips. The length of the sealing strips extends axially along the catheter body 1, and the sealing strips are attached to the outer surface of the fitting portion 13. The two sealing strips are spaced apart on both radially adjacent edges of the fitting portion 13. The sealing strips are made of flexible silicone material, forming a peripheral seal after the fitting portion 13 comes into contact with the target tissue, improving the airtightness of the adsorption pore 131 and enhancing the adsorption effect. The sealing strips form sealing protrusions 132, reducing the processing difficulty of the fitting portion 13; moreover, the sealing strips are relatively soft, providing better sealing performance and reducing damage to the target tissue.

[0040] The shaped tube 16 can be at least one solid metal wire, or at least one hollow metal tube, or simultaneously have solid metal wires and hollow metal tubes arranged in parallel. When multiple solid metal wires or hollow metal tubes are arranged in parallel, each solid metal wire or metal tube is kept insulated from other electrical components (such as the insulated wire 21 of the ablation electrode 2) within the tube cavity 12 to prevent high-voltage pulse conduction.

[0041] The catheter body 1 is made of flexible plastic, and the shaping tube 16 is made of malleable metal. Exemplarily, in one embodiment, the flexible plastic is PFA (perfluoroalkoxy polymer), which has excellent insulation properties, and the softness of PFA does not affect the bending deformation of the shaping tube 16; the two work together to achieve a combination of malleability and high insulation. The catheter body 1 is formed into the outline of the ablation segment 11 through extrusion molding, a relatively simple processing method. The malleable metal is any one of pure aluminum, aluminum alloy, soft-annealed stainless steel, pure copper, or copper alloy; its hardness should be sufficient for an adult surgeon to bend it by hand, while maintaining its shape against external forces during surgical procedures after bending. When the shaped tube 16 is a hollow metal tube, the wall thickness of the hollow metal tube is 0.2mm to 0.4mm. The hollow metal tube can be bent under a hand force of 10N to 30N, and the bending angle can reach 0° to 180°. The residual springback angle after bending does not exceed 5°, combining the convenience of shaping and shape stability. Pure aluminum is aluminum metal with an aluminum mass fraction ≥99.0%; pure copper is copper metal with a copper mass fraction ≥99.9%; soft annealed stainless steel, also known as soft-state annealed stainless steel, refers to the soft material obtained by fully recrystallizing annealing cold-rolled stainless steel, eliminating the work hardening caused by cold rolling, reducing hardness and increasing plasticity, making it suitable for bending and stretching.

[0042] In one embodiment, the conduit body 1 has multiple mutually isolated lumens 12, which are parallel to each other and extend along the axial direction of the conduit body 1. The multiple lumens 12 are used to pass through multiple structural components such as the plastic tube 16 and the insulated wire 21, so as to realize the separate cavity setting of each structural component, avoid mutual interference and entanglement between structural components, and improve the structural stability of the conduit body 1. At the same time, it is beneficial to isolate the fluid passage and electrical circuit within the lumen 12 from each other, reduce the risk of electrical interference, and ensure the reliability and insulation of electrical connection.

[0043] In one embodiment, the hollow metal tube has a receiving cavity extending along its own axis. The receiving cavity serves as an auxiliary channel for threading a positioning guidewire or other instruments, or for irrigation fluid, etc. This makes full use of the internal space of the hollow metal tube, eliminating the need for additional independent lumens, simplifying the internal structure of the catheter body 1, reducing the outer diameter of the catheter body 1, improving the passability of the surgical ablation catheter, and enhancing the convenience of operation.

[0044] In one embodiment, the bonding portion 13 also has a through-hole 133, which is located between two adjacent ablation electrodes 2. Preferably, two adsorption holes 131 are also provided between two adjacent ablation electrodes 2, and the 133 is located between the two adsorption holes 131. An infusion conduit communicating with the 133 is provided in the lumen 12, and the proximal end of the infusion conduit is connected to an infusion device (not shown in the figure). The infusion device infuses a flushing medium, such as physiological saline, into the surface of the target tissue through the infusion hole 133. Blood may seep out of the target tissue such as the epicardium. The blood seeping out and covering the surface of the bonding portion 13 will shunt the pulse electric field and reduce the electric field strength at the target tissue. Therefore, by infusing with physiological saline, the thin layer of blood seeping out on the surface of the bonding portion 13 is flushed away, and the bypass shunt of the pulse current caused by blood is inhibited.

[0045] In one embodiment, the length of the straight side 15 is L1, and the diameter of the arc side 14 is L2, where 0.6×L2≤L1≤0.85×L2. For example, L1 is equal to 0.6×L2, or 0.7×L2, or 0.85×L2, or any value between 0.6×L2 and 0.85×L2. By limiting the dimensions of the straight side 15 and the arc side 14 as described above, a more reasonable cross-sectional structure ratio can be obtained. This ensures that the fitting part 13 has sufficient planar area, which is convenient for setting the ablation electrode 2 and the adsorption hole 131, and ensures the effective fitting area with the target tissue. At the same time, the structural dimensions of the arc side 14 are maintained to ensure the radial structural strength of the catheter body 1, improve the deformation resistance of the fitting part 13, avoid bending deformation under negative pressure adsorption and cardiac pulsation, stably maintain the shape of the surgical ablation catheter, and ensure the reliable performance of the ablation operation.

[0046] Optionally, imaging markers, such as barium sulfate rings, can be placed between the ablation electrodes 2 on the outer surface of the catheter body 1 to facilitate intraoperative X-ray or ultrasound positioning.

[0047] This embodiment of the surgical ablation catheter, designed to meet surgical aseptic requirements, comprises a single-use unit consisting of the catheter body 1, ablation electrode 2, negative pressure assembly 3, and handle 4. Before leaving the factory, it is sterilized with ethylene oxide and then individually aseptically packaged. In use, the proximal connector of the negative pressure assembly 3 connects to a reusable negative pressure generating device, and the proximal connector of the insulated wire 21 of the ablation electrode 2 connects to the reusable external pulse electric field generator wire. After ablation, the entire surgical ablation catheter is discarded to avoid cross-infection and improve reliability.

[0048] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the implementation of the present invention. Those skilled in the art can make other variations or modifications based on the above description. It is neither necessary nor possible to exhaustively describe all embodiments here. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the scope of protection of the claims of the present invention.

Claims

1. A surgical ablation catheter, characterized in that, include: The catheter body (1) includes an ablation segment (11) disposed at the distal end. The catheter body (1) has a lumen (12) inside. Along the axial direction perpendicular to the catheter body (1), the cross-sectional shape of the ablation segment (11) is arc-shaped, the arc shape has an arc side (14) and a straight side (15), the ablation segment (11) has a fitting portion (13) corresponding to the straight side (15), the fitting portion (13) extends along the plane, and the fitting portion (13) is used to abut against the target tissue. At least one ablation electrode (2) is disposed on the outside of the bonding portion (13) and extends along the bonding portion (13); A plastic tube (16) is inserted into the lumen (12) and extends along the axial direction of the catheter body (1). The plastic tube (16) can be plastically bent so that the catheter body (1) maintains the corresponding bending posture.

2. The surgical ablation catheter according to claim 1, characterized in that, The fitting part (13) has a through suction hole (131). The surgical ablation catheter also includes a negative pressure component (3). The negative pressure component (3) is disposed in the lumen (12). The proximal end of the negative pressure component (3) is connected to a negative pressure generating device, and the distal end is in fluid communication with the suction hole (131). The negative pressure component (3) is used to provide negative pressure to the suction hole (131) so that the fitting part (13) fits the target tissue.

3. The surgical ablation catheter according to claim 2, characterized in that, The fitting part (13) has a plurality of adsorption holes (131), which are spaced apart along the axial direction of the catheter body (1).

4. The surgical ablation catheter according to claim 3, characterized in that, The surgical ablation catheter includes a plurality of ablation electrodes (2), which are spaced apart along the axial direction of the catheter body (1), and the ablation electrodes (2) and the adsorption holes (131) are staggered.

5. The surgical ablation catheter according to claim 2, characterized in that, The fitting part (13) is provided with sealing protrusions (132) on both sides along the radial direction, and the adsorption hole (131) is located between the two sealing protrusions (132).

6. The surgical ablation catheter according to claim 5, characterized in that, Along a direction perpendicular to the bonding portion (13), the height of the ablation electrode (2) is not less than the height of the sealing protrusion (132); and / or, The surgical ablation catheter also includes two sealing strips. The length of the sealing strips extends along the axial direction of the catheter body (1). The sealing strips are attached to the outer surface of the fitting part (13). The two sealing strips are spaced apart on both radial edges of the fitting part (13).

7. The surgical ablation catheter according to claim 1, characterized in that, The shaped tube (16) comprises at least one solid metal wire and / or the shaped tube (16) comprises at least one hollow metal tube; and / or, The material of the catheter body (1) is flexible plastic, and the material of the shaped tube (16) is malleable metal.

8. The surgical ablation catheter according to claim 7, characterized in that, The shaped tube (16) includes a hollow metal tube having a receiving cavity extending along its own axial direction.

9. The surgical ablation catheter according to claim 7, characterized in that, The material of the shaped tube (16) is aluminum, aluminum alloy, stainless steel, copper, or copper alloy.

10. The surgical ablation catheter according to any one of claims 1-9, characterized in that, The length of the straight side (15) is L1, and the diameter of the arc side (14) is L2, 0.6×L2≤L1≤0.85×L2.

Images