Pulse ablation catheters and pulse ablation devices

Abstract

This invention discloses a pulse ablation catheter and a pulse ablation device, belonging to the field of pulse ablation technology. This pulse ablation catheter expands the ablation electric field range while maintaining the flexibility of the distal tube. The pulse ablation catheter includes an ablation component and a distal tube. The ablation component receives pulse signals to perform pulse ablation on the target tissue. The ablation component includes a positive electrode group and a negative electrode group, which are disposed on the distal tube and sequentially distributed along the axial direction of the distal tube. The positive electrode group includes at least two axially distributed positive electrodes with a spacing between adjacent positive electrodes; the negative electrode group includes at least two axially distributed negative electrodes with a spacing between adjacent negative electrodes.

Description

Technical Field

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

[0002] Pulsed ablation is an effective treatment for persistent atrial fibrillation and ventricular arrhythmias. By applying an ablation electric field to the lesion using a pulsed ablation device, pores are created in the cell membrane of target cells, thereby disrupting cell stability and causing apoptosis.

[0003] The pulse ablation catheter is a crucial component of pulse ablation equipment, comprising a distal catheter body and an ablation assembly mounted on the distal catheter body. During use, the distal catheter body is advanced through a blood vessel to the target area, and the ablation assembly applies an ablation electric field to the target cells in the target area, achieving pulse ablation.

[0004] In related technologies, the ablation assembly has a positive electrode and a negative electrode. To expand the ablation range, the length of the positive and negative electrodes along the axial direction of the distal tube needs to be increased. However, this also increases the rigidity of the distal tube, making it difficult for the distal tube to adapt to the complex and curved structure of the human body, thus hindering the accurate delivery of the electrode to the target area. Summary of the Invention

[0005] The technical problem to be solved by the present invention is to overcome the defect of high distal tube hardness when increasing the ablation range of the catheter in the prior art, and to provide a pulse ablation catheter and pulse ablation device.

[0006] The present invention solves the above-mentioned technical problems through the following technical solution:

[0007] In a first aspect, embodiments of the present invention provide a pulse ablation catheter, the pulse ablation catheter including an ablation component and a distal tube body, the ablation component being used to receive pulse signals to discharge and perform pulse ablation on target tissue;

[0008] The ablation assembly includes a positive electrode group and a negative electrode group, which are disposed on the distal tube and distributed sequentially along the axial direction of the distal tube.

[0009] The positive electrode group includes at least two positive electrodes distributed along the axial direction, with adjacent positive electrodes having a spacing; the negative electrode group includes at least two negative electrodes distributed along the axial direction, with adjacent negative electrodes having a spacing.

[0010] Optionally, both the positive electrode and the negative electrode are annular electrodes sleeved on the distal tube body.

[0011] The diameters of the positive electrode and the negative electrode are 0.3 mm to 3 mm; and / or,

[0012] The lengths of the positive electrode and the negative electrode along the axial direction of the distal tube are 0.5 mm to 4 mm.

[0013] Optionally, the distance between adjacent positive electrodes is less than or equal to the distance between adjacent positive electrode groups and negative electrode groups;

[0014] The distance between adjacent negative electrodes is less than or equal to the distance between adjacent positive electrode groups and negative electrode groups.

[0015] Optionally, the spacing between adjacent positive electrodes is configured to be 0.3 mm to 4 mm; and / or,

[0016] The spacing between adjacent negative electrodes is configured to be 0.3 mm to 4 mm.

[0017] Optionally, the spacing between adjacent positive electrode groups and negative electrode groups is configured as follows:

[0018] L1≤L2≤a·L1 b +c

[0019] Wherein, L1 is the distance between adjacent positive electrodes or adjacent negative electrodes, and the distance between adjacent positive electrodes is equal to the distance between adjacent negative electrodes;

[0020] L2 is the distance between adjacent positive electrode groups and negative electrode groups;

[0021] a, b, and c are the fitting coefficients.

[0022] Optionally, the positive electrode group and the negative electrode group are distributed alternately on the distal tube.

[0023] Optionally, the pulse ablation catheter further includes a proximal tube body and a handle, wherein the handle, the proximal tube body, and the distal tube body are connected sequentially.

[0024] The distal tube has a first inner cavity, the proximal tube has a second inner cavity communicating with the first inner cavity, and the handle is provided with an electrode socket, which communicates with the second inner cavity;

[0025] The ablation assembly also includes an electrode wire that connects the positive electrode and the negative electrode and extends through the first cavity and the second cavity to connect with the electrode socket.

[0026] Optionally, the handle is further provided with a guide interface that communicates with the second inner cavity;

[0027] The pulse ablation catheter also includes a guide, which enters the second inner lumen from the guide interface and extends to the first inner lumen;

[0028] The end of the first inner cavity furthest from the second inner cavity is a closed end, or...

[0029] The end of the first inner cavity away from the second inner cavity is an open end. A protective tube and a sealing member are also provided in the first inner cavity. The protective tube is sleeved outside the guide to isolate the guide and the electrode wire. The sealing member is provided at the open end to block the space formed by the outer side of the protective tube and the first inner cavity.

[0030] Optionally, the second inner cavity includes a wire channel and a guide channel, the wire channel accommodating the electrode wire, and the guide channel accommodating the guide.

[0031] Optionally, the handle is provided with a drive assembly;

[0032] The proximal tube includes an outer tube and an inner tube disposed within the outer tube. One end of the inner tube is connected to the drive assembly, and the other end is connected to the distal tube. The inner tube is used to drive the distal tube to move axially along the outer tube by the drive assembly.

[0033] Optionally, the drive assembly includes a motor connected to the inner tube; or, the drive assembly includes a guide portion and a drive portion.

[0034] The guide part is movably connected to the drive part and is used to restrict the drive part from moving in a set direction. The drive part is connected to the inner tube and is used to move in the set direction under external force so as to drive the inner tube to move.

[0035] Optionally, the inner tube includes a wire sheath and a support tube;

[0036] A connecting pipe is provided in the outer tube, which connects the inner tube and the distal tube body. The connecting pipe is provided with a wire channel and a guide channel.

[0037] The wire channel is connected to the wire sleeve to accommodate the electrode wire;

[0038] The guide channel is connected to the support tube to accommodate the guide.

[0039] Optionally, the outer pipe includes a support pipe section and an intermediate pipe section distributed along the axial direction, wherein the radial cross-sectional area of ​​the support pipe section is greater than the radial cross-sectional area of ​​the intermediate pipe section.

[0040] Secondly, embodiments of the present invention provide a pulse ablation device, the pulse ablation device including the pulse ablation catheter provided in the first aspect above.

[0041] Optionally, the pulse ablation device further includes a pulse energy output device.

[0042] The pulse energy output device is electrically connected to the pulse ablation catheter ablation assembly, and the pulse energy output device is used to output pulse signals to the ablation assembly;

[0043] Optionally, the pulse ablation device further includes a detection device, which is electrically connected to the pulse energy output device. The detection device is used to acquire the electrocardiogram of the target object and send a trigger command to the pulse energy output device when a preset waveform is detected, so that the pulse energy output device outputs the pulse signal based on the trigger command.

[0044] The positive and progressive effects of this invention are as follows:

[0045] Since the ablation assembly includes at least two positive electrodes in the positive electrode group and at least two negative electrodes in the negative electrode group, the surface area of ​​the electrode group can be increased by increasing the number of electrodes, thereby expanding the range of the ablation electric field. Furthermore, there is a gap between adjacent electrodes of the same polarity, and the distal tube is not covered by the electrodes at the gap, preserving good flexibility. In this way, the influence of multiple electrodes on the overall rigidity of the distal tube is reduced. In other words, this embodiment increases the ablation range while maintaining the flexibility of the distal tube by setting the electrode spacing, allowing the distal tube to adapt to the complex and curved structures within the human body, ensuring the ablation assembly is successfully delivered to the target area. Simultaneously, the use of two adjacent electrodes can also be used for signal mapping after ablation to determine the immediate ablation effect. Attached Figure Description

[0046] Figure 1 This is a schematic diagram of the structure of a pulse ablation catheter according to an exemplary embodiment;

[0047] Figure 2 This is a schematic diagram of the structure at the ablation component according to an exemplary embodiment;

[0048] Figure 3-1 This is a graph illustrating the relationship between electric field strength at the electrode edge and tissue depth under different electrode surface areas, according to an exemplary embodiment.

[0049] Figure 3-2 This is a diagram showing the relationship between the electric field strength and tissue depth in the intermediate region between adjacent electrodes under different electrode surface areas, according to an exemplary embodiment.

[0050] Figure 4 This is a schematic diagram of the structure at the ablation component according to another exemplary embodiment;

[0051] Figure 5-1 and Figure 5-2 These are ablation electric field distribution diagrams shown according to different exemplary embodiments;

[0052] Figure 6 This is a graph illustrating the variation of ablation depth with the spacing between adjacent positive and negative electrode groups under different electrode spacings, according to an exemplary embodiment.

[0053] Figures 7-1 to 7-3 This is a schematic diagram of the structure of the distal tube body according to different exemplary embodiments;

[0054] Figure 8-1 and Figure 8-2 This is a schematic diagram of the radial cross-section of the proximal tube body according to different exemplary embodiments;

[0055] Figure 9 This is a schematic diagram of the structure of a pulse ablation catheter according to another exemplary embodiment;

[0056] Figure 10 This is a schematic diagram of the structure at the connection between the distal tube and the outer tube according to another exemplary embodiment;

[0057] Figure 11-1 and Figure 11-2 This is a schematic diagram of the structure of a pulse ablation device according to different exemplary embodiments.

[0058] The meanings of the markings in the diagram are as follows:

[0059] 100. Ablation assembly; 110. Positive electrode assembly; 111. Positive electrode; 120. Negative electrode assembly; 121. Negative electrode; 130. Electrode lead; 141. First ablation range; 142. Second ablation range; 143. Third ablation range;

[0060] 200. Distal tube body; 210. First inner cavity; 220. Plug; 230. Protective tube; 240. Sealing component;

[0061] 300. Proximal tube body; 310. Second inner cavity; 311. Conductor cavity; 312. Guide cavity; 313. Cable cavity; 320. Outer tube; 321. Supporting tube section; 322. Intermediate tube section; 330. Inner tube; 331. Conductor sleeve; 332. Supporting tube; 333. Cable sleeve; 340. Connecting tube; 341. Conductor channel; 342. Guide channel; 350. Cable;

[0062] 400, Handle; 410, Electrode socket; 420, Guide interface; 430, Drive assembly;

[0063] 500. Guide components;

[0064] 600. Pulse energy output device;

[0065] 700. Detection equipment. Detailed Implementation

[0066] The present invention will be further illustrated by way of embodiments below, but the present invention is not limited to the scope of the embodiments described herein.

[0067] In related technologies, when expanding the ablation range of an ablation assembly, the diameter of the distal tube is difficult to change, so the length of the electrode along the axial direction of the distal tube in the ablation assembly is usually increased. However, this approach also increases the hardness of the distal tube and reduces its flexibility, making it difficult for the distal tube to adapt to complex tissue structures and making it difficult to deliver the electrode smoothly to the target area.

[0068] To address the aforementioned issues, this embodiment provides a pulsed ablation catheter and a pulsed ablation device that balances ablation range and distal catheter flexibility. The specific details of this embodiment are described below with reference to the accompanying drawings.

[0069] Firstly, this embodiment provides a pulse ablation catheter. Figure 1 This is a schematic diagram of the structure of a pulse ablation catheter according to an exemplary embodiment. Figure 2 This is a schematic diagram illustrating the structure of the ablation component in a pulsed ablation catheter according to an exemplary embodiment. Figure 1 and Figure 2 As shown, the pulse ablation catheter provided in this embodiment includes an ablation component 100, a distal tube body 200, a proximal tube body 300, and a handle 400. The distal tube body 200, the proximal tube body 300, and the handle 400 are connected sequentially. The ablation component 100 includes a positive electrode group 110 and a negative electrode group 120 disposed on the distal tube body 200.

[0070] The ablation assembly 100 applies an ablation electric field through the positive electrode group 110 and the negative electrode group 120. The distal tube 200 is flexible and is used to deliver the ablation assembly 100 to the target area within the tissue. The proximal tube 300 supports the distal tube 200, facilitating its smooth entry into the tissue.

[0071] When using this ablation catheter, the operator holds the handle 400 and inserts most of the proximal tube 300 and the distal tube 200 into the tissue to deliver the ablation component 100 to the target area. The distal tube 200 has a diameter of 1F to 10F, a hardness of 20D to 40D, and a length of 50mm to 400mm. Accordingly, the distal tube 200, carrying the ablation component 100, can perform pulsed ablation at locations such as the great cardiac vein and the vain of Marshall (VOM).

[0072] In this embodiment, the positive electrode group 110 and the negative electrode group 120 are sequentially distributed along the axial direction 200x of the distal tube body 200. The positive electrode group 110 includes at least two positive electrodes 111 distributed along the axial direction 200x, with a gap between adjacent positive electrodes 111. The negative electrode group 120 includes at least two negative electrodes 121 distributed along the axial direction 200x, with a gap between adjacent negative electrodes 121.

[0073] In this way, at least two electrodes are used as electrodes of the same polarity. In this case, the surface area of ​​an electrode group is increased by increasing the number of electrodes of the same polarity.

[0074] Figure 3-1 This is a graph illustrating the relationship between electric field strength at the electrode edge and tissue depth under different electrode surface areas, according to an exemplary embodiment. Figure 3-2 This is a diagram illustrating the relationship between the electric field strength and tissue depth in the intermediate region between adjacent electrodes under different electrode surface areas, according to an exemplary embodiment.

[0075] The surface area of ​​the electrode is related to the range of the ablation field. For example... Figure 3-1 As shown, the electric field strength at the electrode edge decreases with increasing electrode surface area, and the rate of decrease in electric field strength along the tissue depth direction slows down with increasing electrode surface area. However, excessively high electric field strength at the electrode edge can easily lead to ionization reactions, affecting the safety of the ablation device. Figure 3-2 As shown, the electric field strength in the region between adjacent electrodes increases with the increase of electrode surface area.

[0076] In summary, increasing the surface area of ​​the electrode can increase the range of the ablation field and reduce the electric field strength at the electrode edge, thereby reducing the risk of ionization reaction.

[0077] In this embodiment, by increasing the number of electrodes in an electrode group, the surface area of ​​the electrode group is increased, thereby expanding the range of the ablation electric field of the ablation component 100. Furthermore, there is a gap between adjacent electrodes of the same polarity, and the distal end of the tube 200 at the gap is not covered by the electrode, maintaining good flexibility. In addition, this method allows for the use of two adjacent electrodes to perform electrical signal mapping before and after ablation to determine the immediate ablation effect. For example, the two farthest electrodes on the distal tube 200 can be used for electrical signal mapping.

[0078] In this way, the influence of multiple electrodes on the overall rigidity of the distal tube 200 is reduced. In other words, this embodiment increases the ablation range while taking into account the flexibility of the distal tube 200 by setting the electrode spacing, so that the distal tube 200 can adapt to the complex curved structures in the human body, ensuring that the ablation component 100 is delivered smoothly to the target area. At the same time, the two adjacent electrodes with spacing can be used for electrical signal mapping before and after ablation to determine the immediate ablation effect.

[0079] Both the positive electrode 111 and the negative electrode 121 are annular electrodes fitted onto the distal tube 200, such as platinum-iridium alloy annular electrodes or gold annular electrodes. The diameters of the positive electrode 111 and the negative electrode 121 are 0.3 mm to 3 mm, for example, 0.5 mm, 1 mm, 1.5 mm, 2 mm, 2.5 mm, etc. The lengths of the positive electrode 111 and the negative electrode 121 along the axial direction of the distal tube are 0.5 mm to 4 mm, for example, 1.0 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 3.5 mm, etc. This size range further avoids increasing the hardness of the distal tube 200 and reduces the defect of easy ionization reaction caused by excessively small electrodes.

[0080] In this embodiment, the sum of the surface areas of the positive electrodes 111 in a group of positive electrodes 110 is the same as the sum of the surface areas of the negative electrodes 121 in a group of negative electrodes 120. For example, the number of positive electrodes 111 in a positive electrode group 110 and the specifications (including length and diameter) and the number of negative electrodes 121 in a negative electrode group 120 are the same. Accordingly, when a group of positive electrodes 110 and a group of negative electrodes 120 participate in discharge, an ablation electric field with uniform field strength distribution can be achieved. The number of electrodes in an electrode group is not specifically limited.

[0081] The number of positive electrode groups 110 and negative electrode groups 120 is not specifically limited. When two or more pairs of positive electrode groups 110 and negative electrode groups 120 are provided on the distal tube 200, the positive electrode groups 110 and negative electrode groups 120 are distributed alternately. In this way, while keeping the position of the distal tube 200 unchanged, different ablation ranges can be achieved by selecting positive electrode groups 110 and negative electrode groups 120 at different positions on the distal tube 200 to participate in the discharge, so as to meet different application requirements.

[0082] Figure 4 This is a schematic diagram of the structure at the ablation component according to another exemplary embodiment. (e.g.) Figure 4 As shown, two sets of positive electrode groups (110a, 110b) and two sets of negative electrode groups (120a, 120b) are distributed alternately. The first ablation range 141 is achieved by using positive electrode group 110a and negative electrode group 120a for discharge; the second ablation range 142 is achieved by using positive electrode group 110b and negative electrode group 120a for discharge; and the third ablation range 143 is achieved by using positive electrode group 110b and negative electrode group 120b for discharge.

[0083] During discharge, the intensity of the ablation electric field is maximum at the electrode surface and gradually decreases away from the electrode. Between electrodes of opposite polarity, the electric field intensity gradually decreases from the electrode edge towards the center region. Therefore, the electrode spacing affects the electric field intensity distribution. In this embodiment, to achieve a continuous and effective ablation electric field, the spacing between electrodes of the same polarity and electrodes of different polarities is configured as follows.

[0084] First, the distance between adjacent same-polarity electrodes

[0085] The spacing between adjacent electrodes of the same polarity refers to the distance between adjacent positive electrodes 111 in a positive electrode group 110, or the distance between adjacent negative electrodes 121 in a negative electrode group 120. In this embodiment, the spacing between electrodes of the same polarity is configured to be 0.3mm to 4mm, such as 1mm, 1.5mm, 2mm, etc.

[0086] Figure 5-1 and Figure 5-2 These are ablation electric field distribution diagrams illustrated according to different exemplary embodiments. Figure 5-1 and Figure 5-2 For example, the positive electrode group 110 includes two positive electrodes 111, and the negative electrode group 120 includes two negative electrodes 121. Figure 5-1 and Figure 5-2 The spacing between the same type of electrodes is different. Figure 5-1 The spacing between isotropic electrodes is less than Figure 5-2 Spacing between isotropic electrodes.

[0087] contrast Figure 5-1 and Figure 5-2 When L1 is large, the ablation field between adjacent electrodes of the same polarity is discontinuous, and the ablation assembly cannot form a continuously distributed ablation field. Furthermore, if L1 is too small, it is not conducive to expanding the range of the ablation field. Considering both the continuity and range of the electric field, in this embodiment, the spacing between electrodes of the same polarity is 0.3 mm to 4 mm.

[0088] Second, the spacing between adjacent opposite electrodes

[0089] The spacing between adjacent opposite electrodes refers to the distance between adjacent positive electrode groups 110 and negative electrode groups 120. In this embodiment, the spacing between adjacent opposite electrodes is related to the spacing between adjacent same electrodes.

[0090] Figure 6 This is a graph illustrating the variation of ablation depth with the distance between adjacent positive and negative electrode groups under different electrode spacings, according to an exemplary embodiment. L1 represents the distance between adjacent same-polarity electrodes, and L2 represents the distance between adjacent opposite-polarity electrodes. Figure 6As shown, with L1 remaining constant, when L2 is less than the critical value, the ablation depth does not change significantly with increasing L2; however, when L2 is greater than the critical value, the ablation depth continuously decreases with increasing L2. Furthermore, for the same ablation depth, different L1 values ​​correspond to different L2 values. When L2 is too small, ionization is easily generated between adjacent opposite electrodes, causing tissue vaporization and the formation of bubbles; when L2 is too large, the ablation depth decreases, affecting the ablation effect.

[0091] Therefore, in this embodiment, the spacing between adjacent heterogeneous electrodes is configured as follows:

[0092] L1≤L2≤a·L1 b +c

[0093] Where L1 is the distance between adjacent electrodes of the same polarity;

[0094] L2 is the distance between adjacent positive electrode groups and negative electrode groups;

[0095] a, b, and c are fitting coefficients. Optionally, the value range of a is [-1, -0.01], the value range of b is [0.5, 3.5], and the value range of c is [4.2, 9.2].

[0096] It should be noted that, in this embodiment, the spacing between the positive electrodes 111 in the positive electrode group 110 is the same as the spacing between the negative electrodes 121 in the negative electrode group 120. In this way, the loads of the positive electrode group 110 and the negative electrode group 120 participating in the discharge are equal, ensuring safe use; and the electric field strength of the ablation electric field achieved by the electrode group is uniformly distributed, which is convenient for use.

[0097] In summary, this embodiment employs multiple electrodes to form an electrode group, increasing the surface area of ​​the electrode group by increasing the number of electrodes to expand the ablation range. By leaving gaps between adjacent electrodes, the flexibility of the distal tube 200 is ensured to adapt to complex tissue structures. Furthermore, by limiting the spacing between adjacent same-polarity electrodes and adjacent opposite-polarity electrodes, the ablation assembly 100 provides a continuous and uniformly distributed ablation electric field, ensuring the ablation effect.

[0098] See also Figure 1 The distal tube 200 has a first inner cavity 210, the proximal tube 300 has a second inner cavity 310, and the handle 400 is provided with an electrode socket 410 and a guide interface 420. The second inner cavity 310 connects the first inner cavity 210 and the electrode socket 410, and the second inner cavity 310 also connects the first inner cavity 210 and the guide interface 420.

[0099] The ablation assembly 100 also includes electrode leads 130, which connect the positive electrode 111 and the negative electrode 121, and extend along the first inner cavity 210 and the second inner cavity 310 to connect with the electrode socket 410. The electrode socket 410 is used to electrically connect to a pulse energy output device, providing a pulse signal to the ablation assembly 100 through the electrode leads 130, thereby generating an ablation electric field. The electrode leads 130 are disposed within the first inner cavity 210 and the second inner cavity 310 to avoid contact with blood and ensure device safety. Optionally, the electrode leads 130 include multiple independently distributed leads, with each electrode connected to a corresponding lead.

[0100] The pulse ablation catheter also includes a guide 500, which enters the second lumen 310 from the guide interface 420 and extends into the first lumen 210. The guide 500 increases the internal rigidity of the distal tube body 200, preventing deformation of the distal tube body 200 during tissue displacement.

[0101] In this embodiment, the distal tube 200 and the proximal tube 300 can be implemented in various ways to accommodate the electrode wire 130 and the guide 500. Figures 7-1 to 7-3 The following is a schematic diagram of the structure of the distal tube body according to different exemplary embodiments, which will be described in detail below with reference to the accompanying drawings.

[0102] like Figure 7-1 As shown, the end of the first inner cavity 210 away from the second inner cavity (not shown) is a closed end, enclosing the electrode wire 130 and the guide 500 within the first inner cavity 210. For example, a plug 220 is provided at the end of the distal tube 200 to seal the first inner cavity 210, or the distal tube 200 is a one-piece molded structure. In this case, contact between the electrode wire 130 and the blood is avoided.

[0103] like Figure 7-2 and Figure 7-3 As shown, the end of the first inner cavity 210 away from the second inner cavity (not shown in the figure) is an open end, and the guide 500 extends out of the first inner cavity 210 from this open end. At this time, during the displacement of the distal tube 200, the guide 500 first contacts the tissue, and plays a guiding role for the subsequent displacement of the distal tube 200.

[0104] In this situation, to prevent blood from contacting the electrode wire 130, a protective tube 230 and a sealing member 240 are also provided in the first inner cavity 210. The protective tube 230 is sleeved on the guide member 500 to isolate the guide member 500 and the electrode wire 130. The sealing member 240 is located at the open end of the first inner cavity 210, sealing the space formed by the outer side of the protective tube 230 and the first inner cavity 210. Specifically, the sealing member 240 has a ring-shaped structure, forming an annular channel together with the inner wall of the first inner cavity 210 and the outer wall of the protective tube 230 to accommodate the electrode wire 130. At this time, the sealing member 240 prevents the electrode wire 130 from contacting the blood.

[0105] See also Figure 1 The outer diameter of the proximal tube 300 is larger than that of the distal tube 200 to provide support and facilitate the movement of the distal tube 200 within the tissue. The diameter of the second inner cavity 310 is larger than that of the first inner cavity 210 to accommodate other components. For example, an electromagnetic positioning sensor is placed near the distal tube 200 in the proximal tube 300, and the wires of the electromagnetic positioning sensor are placed within the second inner cavity 310.

[0106] Figure 8-1 and Figure 8-2 This is a schematic diagram of the radial cross-section of the proximal tube body according to different exemplary embodiments. For example... Figure 8-1 As shown, the proximal tube 300 is a multi-cavity tube, and the second inner cavity includes a wire cavity 311 for accommodating the electrode wire 130, a guide cavity 312 for accommodating the guide 500, and a cable cavity 313 for accommodating other cables (such as electromagnetic positioning sensor wires).

[0107] like Figure 8-2 As shown, the proximal tube 300 includes an outer tube 320 and an inner tube 330 disposed within the outer tube 320. The inner tube 330 includes independently distributed wire sheaths 331, support tubes 332, and cable sheaths 333. The wire sheath 331 is sleeved on the electrode wire 130, the support tube 332 is sleeved on the guide member 500, and the cable sheath 333 is sleeved on other cables 350 (e.g., electromagnetic positioning sensor wires).

[0108] When the proximal tube body 300 adopts Figure 8-2 In the illustrated configuration, the inner tube 330 can also move relative to the outer tube 320 along the outer tube axial direction. Based on this, the ablation catheter also has the following implementation methods.

[0109] Figure 9 This is a schematic diagram of the structure of a pulse ablation catheter according to another exemplary embodiment. Figure 10 This is a schematic diagram illustrating the structure of the connection between the distal tube and the outer tube according to another exemplary embodiment. Figure 8-2 Based on the combination Figure 9 and Figure 10 A drive assembly 430 is provided on the handle 400. One end of the inner tube 330 in the proximal tube 300 is connected to the drive assembly 430, and the other end is connected to the distal tube 200. At this time, the inner tube 330 is driven by the drive assembly 430, causing the distal tube 200 to move axially along the outer tube 320. In this way, the positions of the positive and negative electrode groups on the distal tube 200 in the tissue can be adjusted, thereby adjusting the relative position of the ablation electric field with the target area and optimizing the ablation effect.

[0110] Optionally, the support tube 332 in the inner tube 330 is connected to the drive assembly 430. The support tube 332 is made of polyimide, which has high hardness and is not easily deformed when driven by the drive assembly 430, thus ensuring structural stability.

[0111] Optionally, a connecting pipe 340 is provided in the outer tube 320, connecting the inner tube 330 and the distal tube body 200. The connecting pipe 340 is provided with a wire channel 341 and a guide channel 342. The wire channel 341 communicates with the wire sleeve 331 in the inner tube 330 to accommodate the electrode wire 130. The guide channel 342 communicates with the support tube 332 in the inner tube 330 to accommodate the guide 500.

[0112] The connecting tube 340 ensures a tight seal between the inner tube 330 and the distal tube body 200. The connecting tube is fixedly connected to both the inner tube 330 and the distal tube body 200 (e.g., by bonding or welding). This prevents blood from contacting the electrode leads 130, ensuring device safety.

[0113] The drive assembly 430 can be implemented in several ways. Optionally, the drive assembly 430 includes a motor directly connected to the inner tube 330. Optionally, the drive assembly 430 includes a guide portion and a drive portion. The guide portion is movably connected to the drive portion and is used to limit the movement of the drive portion along a set direction. The drive portion is connected to the inner tube 330 and is used to move along the set direction under external force, thereby driving the inner tube 330 to move. For example, the drive portion is a slider, the guide portion is a slide rail, and the user manually controls the drive portion to move along the guide portion.

[0114] In this situation, when the electrode position needs to be adjusted, the drive component 430 acts on the support tube 332, the support tube 332 drives the connecting tube 340, and in turn drives the distal tube 200 connected to the connecting tube 340 to move.

[0115] Furthermore, the outer tube 320 includes a support segment 321 and an intermediate segment 322 distributed along the axial direction, with the radial cross-sectional area of ​​the support segment 321 being larger than that of the intermediate segment 322. In this case, the structural stability of the support segment 321 is superior to that of the intermediate segment 322, making it less prone to deformation. Accordingly, the morphological stability of the intermediate end 322 is improved by the support segment 321, preventing the intermediate ends 322 from stacking during tissue advancement and affecting the use of the ablation catheter. Optionally, the outer tube 320 is made of a medical polymer material with flexibility, softness, and elasticity, such as nylon or polyesteramine.

[0116] The pulse ablation catheter provided in this embodiment expands the ablation range while maintaining the flexibility of the distal tube, allowing the electrodes in the ablation assembly to be smoothly delivered to the target area within the tissue. Furthermore, by optimizing the electrode layout in the ablation assembly 100, a uniform and continuously distributed ablation electric field is ensured by the pulse ablation catheter. Improvements to the structure of the distal tube 200 and proximal tube 300 ensure safe use of the device and allow for fine-tuning of the electrode positions, guaranteeing that the ablation electric field covers the target area and optimizing the ablation effect.

[0117] Secondly, this embodiment provides a pulse ablation device, which includes the pulse ablation catheter provided in Embodiment 1 above. Figure 11-1 and Figure 11-2 These are schematic diagrams illustrating the structure of a pulse ablation device according to different exemplary embodiments. For example... Figure 11-1 As shown, the pulse ablation device includes Figure 1 The pulse ablation catheter shown is as follows: Figure 11-2 As shown, the pulse ablation device includes Figure 9 The pulse ablation catheter shown.

[0118] In addition, the pulse ablation device also includes a pulse energy output device 600 and a detector 700. The pulse energy output device 600 is electrically connected to the electrode socket 410 on the handle 400 of the pulse ablation catheter. The pulse energy output device 600 is also electrically connected to the ablation assembly 100 and is used to output a pulse signal to excite the ablation assembly 100 to generate an ablation electric field. Optionally, the pulse width of the pulse signal output by the pulse energy output device 600 is 0.5µs to 100µs, and the voltage range is 500V to 2000V. Optionally, the pulse energy output device 600 also includes an interactive interface for operators to adjust pulse parameters.

[0119] The detector 700 is electrically connected to the pulse energy output device 600 to acquire the electrocardiogram (ECG) of the target object. When the detector 700 detects a preset waveform (e.g., P wave, R wave), it sends a trigger command to the pulse energy output device 600, causing the pulse energy output device 600 to output a pulse signal based on the trigger command. For example, when the detector 700 detects an R wave, it controls the pulse energy output device 600 to output a pulse signal with a delay of 10ms to 200ms to ensure that the pulse release is synchronized with the heart rate.

[0120] The pulse ablation device provided in this embodiment expands the ablation range while also ensuring the operability of the pulse ablation catheter. Specifically, while increasing the electrode surface area, it ensures good flexibility of the distal tube, allowing the electrodes in the ablation assembly to be smoothly delivered to the target area within the tissue, thus optimizing the ablation effect.

[0121] While specific embodiments of the present invention have been described above, those skilled in the art should understand that these are merely illustrative examples, and the scope of protection of the present invention is defined by the appended claims. Those skilled in the art can make various changes or modifications to these embodiments without departing from the principles and essence of the present invention, but all such changes and modifications fall within the scope of protection of the present invention.

Claims

1. A pulsed ablation catheter, comprising: The pulse ablation catheter comprises an ablation assembly for receiving a pulse signal to perform pulse ablation on target tissue, and a distal tube body; The ablation assembly comprises a positive electrode group and a negative electrode group arranged on the distal tube body and sequentially distributed along the axial direction of the distal tube body; The positive electrode group comprises at least two positive electrodes distributed along the axial direction, and adjacent positive electrodes have a spacing; the negative electrode group comprises at least two negative electrodes distributed along the axial direction, and adjacent negative electrodes have a spacing; The spacing between adjacent positive electrode groups and negative electrode groups is configured as: Wherein, L1 is the spacing between adjacent positive electrodes or adjacent negative electrodes, the spacing between adjacent positive electrodes is equal to the spacing between adjacent negative electrodes; L2 is the spacing between adjacent positive electrode groups and negative electrode groups; a, b, c are fitting coefficients; wherein, the value range of a is -1~0.01, the value range of b is 0.5~3.5, and the value range of c is 4.2~9.2; The positive electrode group and the negative electrode group are alternately distributed on the distal tube body. The positive electrode and the negative electrode are both ring electrodes sleeved on the distal tube body, 2. The pulsed ablation catheter of claim 1, wherein, The diameter of the positive electrode and the negative electrode is 0.3mm~3mm; and / or, The length of the positive electrode and the negative electrode along the axial direction of the distal tube body is 0.5mm~4mm. The spacing between adjacent positive electrodes is less than or equal to the spacing between adjacent positive electrode groups and negative electrode groups; 3. The pulsed ablation catheter of claim 1, wherein, The spacing between adjacent negative electrodes is less than or equal to the spacing between adjacent positive electrode groups and negative electrode groups. The spacing between adjacent positive electrodes is configured as 0.3mm~4mm; and / or, 4. The pulsed ablation catheter of claim 3, wherein, The spacing between adjacent negative electrodes is configured as 0.3mm~4mm. The pulse ablation catheter further comprises a proximal tube body and a handle, the handle, the proximal tube body and the distal tube body are sequentially connected; 5. The pulsed ablation catheter of claim 1, wherein, The distal tube body has a first lumen, the proximal tube body has a second lumen in communication with the first lumen, and the handle is provided with an electrode socket in communication with the second lumen; The ablation assembly further comprises an electrode lead wire connected to the positive electrode and the negative electrode and extending to the electrode socket through the first lumen and the second lumen. The handle is further provided with a guide piece interface in communication with the second lumen; 6. The pulsed ablation catheter of claim 5, wherein, The pulse ablation catheter further comprises a guide piece which enters the second lumen from the guide piece interface and extends to the first lumen; The end of the first lumen away from the second lumen is a closed end, or The end of the first lumen away from the second lumen is an open end, and the first lumen is further provided with a protection tube and a blocking piece, the protection tube is sleeved outside the guide piece to isolate the guide piece and the electrode lead wire; the blocking piece is arranged at the open end to block the space formed between the outside of the protection tube and the first lumen. ​ 7. The pulsed ablation catheter of claim 6, wherein, The second inner cavity comprises a wire channel and a guide channel, the wire channel accommodating the electrode wire, and the guide channel accommodating the guide.

8. The pulsed ablation catheter of claim 6, wherein, The handle is provided with a driving assembly; The proximal tube body comprises an outer tube and an inner tube arranged in the outer tube, one end of the inner tube being connected to the driving assembly, and the other end being connected to the distal tube body; the inner tube is used to drive the distal tube body to move along the axial direction of the outer tube under the driving of the driving assembly.

9. The pulsed ablation catheter of claim 8, wherein, The driving assembly comprises a motor connected to the inner tube; or The driving assembly comprises a guide part and a driving part, The guide part is movably connected to the driving part, and is used to limit the movement of the driving part along a set direction, The driving part is connected to the inner tube, and is used to move along the set direction under an external force to drive the inner tube to move.

10. The pulsed ablation catheter of claim 8, wherein, The inner tube comprises a wire sleeve and a support tube; A connecting tube is arranged in the outer tube, the connecting tube connecting the inner tube and the distal tube body, and the connecting tube being provided with a wire channel and a guide channel, The wire channel is in communication with the wire sleeve to accommodate the electrode wire; The guide channel is in communication with the support tube to accommodate the guide.

11. The pulsed ablation catheter of claim 10, wherein, The outer tube comprises axially distributed support tube segments and intermediate tube segments, the radial cross-sectional area of the support tube segments being greater than that of the intermediate tube segments.

12. A pulsed ablation device, characterized by, The pulse ablation device comprises the pulse ablation catheter according to any one of claims 1-11.

13. The pulsed ablation device of claim 12, wherein, The pulse ablation device further comprises a pulse energy output device, The pulse energy output device is electrically connected to the ablation assembly in the pulse ablation catheter, and is used to output a pulse signal to the ablation assembly.

14. The pulsed ablation device of claim 13, wherein, The pulse ablation device further comprises a detection device, The detection device is electrically connected to the pulse energy output device, and is used to acquire an electrocardiogram of a target object, and send a trigger instruction to the pulse energy output device when a preset waveform is detected, so that the pulse energy output device outputs the pulse signal based on the trigger instruction.

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