Pulsed electric field ablation catheter

Abstract

This application provides a pulsed electric field ablation catheter, comprising: a tube body, the tube body including a first tube body segment, a second tube body segment, and a third tube body segment connected in sequence, the second tube body segment being deformable; a handle connected to the third tube body segment; an inner tube sleeved on the tube body and movable along the axial direction of the tube body; an electrode assembly connecting the inner tube and the first tube body segment, the electrode assembly being deformable when the inner tube moves relative to the tube body to adjust the position of the electrodes in the electrode assembly; and an operating mechanism disposed on the handle and connected to the second tube body segment and the inner tube, used to control the deformation and bending of the second tube body segment, and to control the movement of the inner tube relative to the tube body, which can stop at any position within the range of movement. This application uses a dual adjustment mechanism of changing the state of the electrode assembly and the deformation and bending of the second tube body segment to adjust the position of the electrodes, greatly improving the range of electrode position adjustment and increasing the flexibility of surgical operation.

Description

Technical Field

[0001] This application relates to the field of medical devices, and more particularly to a pulsed electric field ablation catheter. Background Technology

[0002] Cardiovascular disease is one of the leading causes of health problems, not only reducing patients' quality of life but also threatening their lives. Traditional radiofrequency ablation is one of the most widely used catheter ablation techniques, but its heat is difficult to control precisely, easily causing thermal damage to adjacent normal tissues and leading to complications.

[0003] Pulsed electric field ablation, as an emerging method for treating cardiovascular diseases, works by ablating specific tissues based on the differences in cell sensitivity to high-intensity, short-duration pulsed electric fields. This results in higher tissue selectivity and faster ablation efficiency. However, the catheter used in pulsed electric field ablation requires a certain degree of rigidity to ensure smooth advancement within the blood vessel and reach the target location. This leads to poor catheter flexibility during the procedure, affecting the surgical outcome. Summary of the Invention

[0004] In view of this, embodiments of this application provide a pulsed electric field ablation catheter to at least partially solve the above-mentioned problems.

[0005] This application provides a pulsed electric field ablation catheter, comprising: a tube body, the tube body including a first tube body segment, a second tube body segment, and a third tube body segment connected in sequence, the second tube body segment being deformable; a handle connected to the third tube body segment; an inner tube sleeved on the tube body and movable along the axial direction of the tube body; an electrode assembly connecting the inner tube and the first tube body segment, wherein the electrode assembly is deformable when the inner tube moves relative to the tube body to adjust the position of the electrodes in the electrode assembly; and an operating mechanism disposed on the handle and connected to the second tube body segment and the inner tube, used to control the deformation of the second tube body segment to bend, and to control the movement of the inner tube relative to the tube body, which can stop at any position within the range of movement.

[0006] Furthermore, in the aforementioned pulsed electric field ablation catheter, the hardness of the second tube segment is lower than that of the first tube segment and the third tube segment.

[0007] Furthermore, in the aforementioned pulsed electric field ablation catheter, the first tube segment is deformable; the operating mechanism is used to simultaneously control the deformation of the first tube segment and the second tube segment to cause bending; or, the operating mechanism is used to control the deformation of the first tube segment and the second tube segment to cause bending independently.

[0008] Furthermore, in the aforementioned pulsed electric field ablation catheter, the hardness of the first tube segment is lower than that of the second tube segment; and the hardness of the second tube segment is lower than that of the third tube segment.

[0009] Furthermore, in the aforementioned pulsed electric field ablation catheter, the operating mechanism includes: a first connecting mechanism connected to the first tube segment and the second tube segment; and a first bending control component disposed on the outer surface of the handle and connected to the first connecting mechanism, for applying force to the first tube segment and the second tube segment through the first connecting mechanism to cause the first tube segment and the second tube segment to bend.

[0010] Furthermore, in the aforementioned pulsed electric field ablation catheter, the first connecting mechanism includes: a first slider slidably connected to the handle along the axial direction of the handle; a first traction wire, with its distal end connected to the first tube segment and its proximal end connected to the first slider, and the distal and proximal ends of the first traction wire also connected to the second tube segment; and a first bending control component connected to the first slider for controlling the sliding of the first slider relative to the handle to apply tension to the first traction wire, thereby causing the first tube segment and the second tube segment to deform and bend.

[0011] Furthermore, in the aforementioned pulsed electric field ablation catheter, the operating mechanism includes: a second connecting mechanism connected to the first tube segment; a second bending control component disposed on the outer surface of the handle and connected to the second connecting mechanism, used to apply force to the first tube segment through the second connecting mechanism to cause the first tube segment to deform and bend; a third connecting mechanism connected to the second tube segment; and a third bending control component disposed on the outer surface of the handle and connected to the third connecting mechanism, used to apply force to the second tube segment through the third connecting mechanism to cause the second tube segment to deform and bend.

[0012] Furthermore, in the aforementioned pulsed electric field ablation catheter, the second connecting mechanism includes a second slider and a second traction wire, and the third connecting mechanism includes a third slider and a third traction wire; the second slider and the third slider are sequentially arranged along the axial direction of the handle and are slidably connected to the handle; the distal end of the second traction wire is connected to the first tube body segment, the proximal end of the second traction wire is connected to the second slider, the distal end of the third traction wire is connected to the second tube body segment, and the proximal end of the third traction wire is connected to the third slider; the second bending control component is connected to the second slider and is used to control the sliding of the second slider relative to the handle to apply tension to the second traction wire; the third bending control component is connected to the third slider and is used to control the sliding of the third slider relative to the handle to apply tension to the third traction wire.

[0013] Furthermore, in the aforementioned pulsed electric field ablation catheter, the first bending control component is a sleeve with internal threads, and the first slider is an annular cylinder with external threads. The first bending control component is sleeved outside the first slider and threadedly connected to the first slider, so that when the first bending control component is screwed, the first slider can be driven to move axially along the handle; or, the second bending control component and the third bending control component are both sleeves with internal threads, and the second slider and the third slider are both annular cylinders with external threads. The second bending control component is sleeved outside the second slider and threadedly connected to the second slider, so that when the second bending control component is rotated, the second slider can be driven to move axially along the handle, and the third bending control component is sleeved outside the third slider and threadedly connected to the third slider, so that when the third bending control component is screwed, the third slider can be driven to move axially along the handle.

[0014] Furthermore, in the aforementioned pulsed electric field ablation catheter, the electrode assembly includes: multiple substrate groups, each substrate group comprising two or more substrates arranged sequentially along the circumference of the inner tube, wherein the substrates connect the inner tube and a first tube body segment, the substrates are deformable, each substrate includes at least a connected first segment and a second segment, a first connection point being provided between the first segment and the second segment, and the first connection point in the same substrate group being contacted to form a connecting portion; an electrode, the electrode being at least disposed in the connecting portion; the operating mechanism further includes: an electrode control assembly, disposed on the handle and connected to the inner tube, for controlling the movement of the inner tube relative to the tube body, thereby causing the substrate to deform to adjust the state of the electrode assembly.

[0015] Furthermore, in the aforementioned pulsed electric field ablation catheter, the electrode control component includes: a push-pull button; the handle has a sliding groove; the push-pull button is movably disposed in the sliding groove and can stop at any position in the sliding groove; one end of the push-pull button located inside the push-pull groove is connected to the inner tube.

[0016] Furthermore, the aforementioned pulsed electric field ablation catheter also includes a Luer component, through which the push-pull button is connected to the inner tube.

[0017] In this embodiment, the inner tube can stop at any position within its range of motion via the operating mechanism, meaning the state of the electrode assembly can change continuously. The electrode assembly can be adjusted as needed, allowing the electrodes to be precisely positioned in various locations, making electrode positioning more flexible and meeting the needs of different surgical procedures, ensuring optimized treatment outcomes. Furthermore, the operating mechanism can control the deformation and bending of the second tube segment, further increasing the position adjustment range of the electrodes in the electrode assembly and making electrode positioning more diverse. It can be seen that this embodiment uses a dual adjustment mechanism—changing the state of the electrode assembly and deforming and bending the second tube segment—to adjust the electrode position, greatly improving the electrode position adjustment range and enhancing the flexibility of surgical procedures.

[0018] It should be understood that the above general description and the following detailed description are exemplary and explanatory only, and do not limit this application. Attached Figure Description

[0019] The above and other objects, features and advantages of this application will become more apparent from the more detailed description of exemplary embodiments thereof in conjunction with the accompanying drawings, wherein the same reference numerals generally represent the same components in the exemplary embodiments thereof.

[0020] Figure 1 This is a schematic diagram of the structure of the pulsed electric field ablation catheter shown in an embodiment of this application;

[0021] Figure 2 This is a schematic diagram of the tube body structure shown in an embodiment of this application;

[0022] Figure 3 This is an axial sectional view of the first tube section and a portion of the second tube section shown in an embodiment of this application;

[0023] Figure 4 This is a diagram showing the bent state of the second pipe section in an embodiment of this application;

[0024] Figure 5 This is a schematic diagram of the handle structure shown in an embodiment of this application;

[0025] Figure 6 for Figure 5 The axial sectional view of the handle is shown.

[0026] Figure 7 This is a schematic diagram of the tube body structure shown in an embodiment of this application;

[0027] Figure 8 This is a schematic diagram of the connection structure of the first traction line shown in an embodiment of this application;

[0028] Figure 9 This is a schematic diagram of the electrode assembly shown in an embodiment of this application;

[0029] Figure 10 This is a schematic diagram of the electrode assembly in a first state as shown in an embodiment of this application;

[0030] Figure 11 This is a top view of the electrode assembly in a first state as shown in an embodiment of this application;

[0031] Figure 12 This is a schematic diagram of the electrode assembly in the second state as shown in an embodiment of this application;

[0032] Figure 13 This is a top view of the electrode assembly in a second state as shown in an embodiment of this application;

[0033] Figure 14 This is a schematic diagram illustrating the working state of the electrode assembly in an embodiment of this application;

[0034] Figure 15 This is a schematic diagram of the structure of the tee component shown in the embodiment of this application;

[0035] Figure 16 for Figure 7 BB cross-sectional view;

[0036] Figure 17 for Figure 7 CC section view. Detailed Implementation

[0037] Preferred embodiments of the present application will now be described in more detail with reference to the accompanying drawings. While preferred embodiments of the present application are shown in the drawings, it should be understood that the present application may be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided to make the present application more thorough and complete, and to fully convey the scope of the present application to those skilled in the art.

[0038] The terminology used in this application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The singular forms “a,” “the,” and “the” used in this application and the appended claims are also intended to include the plural forms unless the context clearly indicates otherwise. It should also be understood that the term “and / or” as used herein refers to and includes any or all possible combinations of one or more of the associated listed items.

[0039] It should be understood that although the terms "first," "second," "third," etc., may be used in this application to describe various components, these components should not be limited to these terms. These terms are only used to distinguish components of the same type from one another. For example, without departing from the scope of this application, a first component may also be referred to as a second component, and similarly, a second component may also be referred to as a first component. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this application, "a plurality of" means two or more, unless otherwise explicitly specified.

[0040] In the description of this application, it should be understood that the terms "length", "width", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this application and 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, and therefore should not be construed as a limitation of this application.

[0041] Unless otherwise expressly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; 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; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this application according to the specific circumstances.

[0042] Pulsed electric field ablation is based on the differences in cell sensitivity to high-intensity, short-duration pulsed electric fields to ablate specific tissues, thus offering higher tissue selectivity and faster ablation efficiency. However, for pulsed electric field ablation catheters, the catheters need to have a certain degree of rigidity to smoothly advance through blood vessels and reach the target location, which limits the catheter's flexibility during the procedure and affects the surgical outcome.

[0043] To address the aforementioned issues, this application provides a pulsed electric field ablation catheter, which can at least partially solve the above-mentioned technical problems.

[0044] The technical solutions of the embodiments of this application are described in detail below with reference to the accompanying drawings.

[0045] See Figure 1 According to one embodiment of this application, a pulsed electric field ablation catheter includes a tube body 100, a handle 200, an inner tube 300, an electrode assembly 400, and an operating mechanism. The handle 200 is located at the proximal end of the tube body 100. Figure 1 The electrode assembly 400 is connected to the right end shown, and the electrode assembly 400 is connected to the distal end of the tube body 100. Figure 1 It is connected to the left end shown. The operating mechanism is located on the outer surface of the handle 200 for easy operation by the operator.

[0046] It is understood that this embodiment may also include a connector 600, a side branch 700, and a loader 800. Both the connector 600 and the side branch 700 are connected to the handle 200. The connector 600 can be used to connect to an ablation or mapping host, such as a multichannel instrument, a three-dimensional mapping host, or an instrument with similar functions. The side branch 700 can be used to deliver liquid to the target location. The loader 800 can function as a device for mounting the pulsed electric field ablation catheter onto the catheter delivery system.

[0047] It should be noted that in the embodiments of this application, the distal end is the end closer to the electrode assembly 400, and the proximal end is the end farther away from the electrode assembly 400.

[0048] The effective length of the pulsed electric field ablation catheter is the length L of the tube body 100 excluding the handle 200 and the length of the electrode assembly 400 connected to the tube body 100. The effective length is the part that can enter the human blood vessels, and its effective length can be determined according to the actual situation, for example, it can be more than 50cm.

[0049] See Figure 2 and Figure 7 The tube body 100 includes a first tube body section 110, a second tube body section 120 and a third tube body section 130 that are coaxially arranged and connected in sequence, and the second tube body section 120 is deformable. Figure 2 The length of the first tube segment 110 shown is L1, the length of the second tube segment 120 is L2, and the length of the third tube segment 130 is L3. The specific values ​​of each length can be determined according to the actual situation, and no limitation is made here in this embodiment.

[0050] In practice, the first tube segment 110, the second tube segment 120, and the third tube segment 130 can all be composed of polymer materials, such as commonly used medical-grade polymer materials, like PEBAX (polyether amide block copolymer), PA (polyamide), and TPU (thermoplastic polyurethane).

[0051] The right end of the handle 200 and the third tube section 130 (relative to) Figure 2 (As shown in the diagram) are connected. An inner tube channel 160 is provided within the tube body 100, see [reference]. Figure 17 The inner tube 300 is sleeved inside the tube body 100 through the inner tube channel 160 and can move along the axial direction of the tube body 100. The distal part of the inner tube 300 ( Figure 1 The left end (shown) extends out of the first tube segment 110. The electrode assembly 400 connects the inner tube 300 (e.g., the distal end of the inner tube 300) to the first tube segment 110. When the inner tube 300 moves relative to the tube body 100, it applies a force to the electrode assembly 400, causing the electrode assembly 400 to deform and change its state. This allows adjustment of the position of the electrodes in the electrode assembly 400 to suit different surgical sites or patients. The inner tube 300 extends axially along the tube body 100, with its proximal end extending into the handle 200.

[0052] In practice, the handle 200, the tube body 100, and the inner tube 300 can be coaxially connected.

[0053] An operating mechanism is located on the handle 200 and connected to the second tube segment 120 and the inner tube 300. It is used to control the deformation and bending of the second tube segment 120, and to control the movement of the inner tube 300 relative to the tube body 100, allowing it to remain stationary and fixed at any position within its range of motion. The operator can use the operating mechanism to control the bending of the second tube segment 120 and the state of the electrode assembly 400.

[0054] See Figure 4 The control mechanism can apply a pulling force to the second tube section 120 towards the proximal end, thereby causing the second tube section 120 to bend back towards the proximal end, driving the electrode assembly 400 to change direction.

[0055] In this embodiment, the inner tube 300 can stop at any position within its range of motion via the operating mechanism, meaning the state of the electrode assembly 400 can continuously change. The electrode assembly 400 can be adjusted as needed, allowing the electrodes to be precisely positioned in various locations, making electrode positioning more flexible and meeting the needs of different surgical procedures, ensuring optimized treatment outcomes. Furthermore, the operating mechanism can control the deformation and bending of the second tube segment 120, further increasing the position adjustment range of the electrodes in the electrode assembly 400 and making electrode positioning more diverse. It can be seen that this embodiment uses a dual adjustment mechanism—changing the state of the electrode assembly 400 and deforming and bending the second tube segment 120—to adjust the electrode position, greatly improving the electrode position adjustment range and enhancing the flexibility of surgical procedures.

[0056] In some embodiments, the second tube segment 120 serves as a bending segment of the overall tube segment 100. The hardness of the second tube segment 120 may be lower than that of the first tube segment 110 and the third tube segment 130, so that the second tube segment 120 is easier to bend and deform.

[0057] In some embodiments, the first tube segment 110 can also bend and deform. An operating mechanism can be used to simultaneously control the bending of the first tube segment 110 and the second tube segment 120. Specifically, the operating mechanism is fixedly connected to the first tube segment 110 and the second tube segment 120, and simultaneously applies a proximal bending force to both tube segments 110 and 120, causing them to bend proximally at the same time. A first bending control component 530 is disposed on the outer surface of the handle 200 and connected to the first slider 510, used to control the sliding of the first slider 510 relative to the handle 200, thereby applying a pulling force to the first tube segment 110 and the second tube segment 120, causing them to bend and bend proximally.

[0058] In some embodiments, see Figures 4 to 8 The operating mechanism includes a first connecting mechanism and a first bending control component 530. The first connecting mechanism is connected to the first tube segment 110 and the second tube segment 120. The first bending control component 530 is disposed on the outer surface of the handle 200 and connected to the first connecting mechanism, and is used to apply force to the first tube segment 110 and the second tube segment 120 through the first connecting mechanism to deform and bend the first tube segment 110 and the second tube segment 120.

[0059] In one specific implementation, see [link to relevant documentation]. Figures 4 to 8 The first connecting mechanism includes a first slider 510 and a first traction line 520. The first slider 510 is slidably connected to the handle 200 along its axial direction. The distal end of the first traction line 520 is connected to the first tube section 110, and the proximal end is connected to the first slider 510. The distal and proximal ends of the first traction line 520 are also connected to a second tube section 120. The second tube section 120 and the third tube section 130 of the tube body 100 are hollow structures, with traction line channels 140 inside for the first traction line 520 to pass through. (See [reference]). Figure 17The first traction wire 520 is installed at the connection between the first tube section 110 and the second tube section 120. The diameter of the distal end of the first traction wire 520 is larger than the diameter of the traction wire channel 140, and the distal end of the first traction wire 520 is encapsulated inside the first tube section 110. The first traction wire 520 is connected to the first slider 510 through the traction wire channel 140. The surgeon can rotate the first bending control component 530 to drive the first slider 510 to move along the axial direction of the tube 100, thereby applying a bending force to the second tube section 120, thus realizing the bending function of the second tube section 120.

[0060] The first traction line 520 should be bendable. The material can be inelastic or have a certain degree of elasticity, as long as it can transmit tensile force. For example, the material can be nylon, rubber, latex, silicone, cotton thread, etc.

[0061] The first traction line 520 and the second tube section 120 can also be connected in the manner described above. Of course, they can also be fixedly connected by other structures. This embodiment does not impose any limitations on this.

[0062] The first bending control component 530 is a sleeve with internal threads, and the first slider 510 is an annular cylinder with external threads. The first bending control component 530 is sleeved on the outside of the first slider 510 and threadedly connected to the first slider 510, so that when the first bending control component 530 is rotated, the first slider 510 can be driven to move along the axial direction of the handle 200.

[0063] This embodiment only illustrates one specific implementation of the operating mechanism. Of course, it can also be implemented by other structures, as long as it can apply tension to the first tube section 110 and the second tube section 120.

[0064] In some embodiments, the operating mechanism can also be used to control the first tube segment 110 and the second tube segment 120 to deform and bend independently. The operator can operate the operating mechanism to control the first tube segment 110 to deform and bend independently, in which case the second tube segment 120 will not deform and bend. Alternatively, the operator can control the second tube segment 120 to deform and bend independently, in which case the first tube segment 110 will not deform and bend.

[0065] In specific implementation, the operating structure may include a first operating mechanism for controlling the bending of the first tube segment 110 and a second operating mechanism for controlling the bending of the second tube segment 120, so as to control the first tube segment 110 and the second tube segment 120 respectively.

[0066] In some embodiments, the operating mechanism includes: a second connecting mechanism, a second bending control component, a third connecting mechanism, and a third bending control component. The second connecting mechanism is connected to the first tube segment 110. The second bending control component is disposed on the outer surface of the handle 200 and connected to the second connecting mechanism, and is used to apply a force to the first tube segment 110 through the second connecting mechanism to cause the first tube segment 110 to deform and bend. The third connecting mechanism is connected to the second tube segment 120. The third bending control component is disposed on the outer surface of the handle 200 and connected to the third connecting mechanism, and is used to apply a force to the second tube segment 120 through the third connecting mechanism to cause the second tube segment 120 to deform and bend.

[0067] In one specific implementation, the second connecting mechanism includes a second slider and a second traction line, and the third connecting mechanism includes a third slider and a third traction line. The second and third sliders are sequentially arranged along the axial direction of the handle 200 and are slidably connected to the handle 200. The distal end of the second traction line is connected to the first tube section 110, the proximal end of the second traction line is connected to the second slider, the distal end of the third traction line is connected to the second tube section 120, and the proximal end of the third traction line is connected to the third slider. A second bending control component is disposed on the outer surface of the handle 200 and connected to the second slider, used to control the sliding of the second slider relative to the handle 200. A third bending control component is disposed on the outer surface of the handle 200 and connected to the third slider, used to control the sliding of the third slider relative to the handle 200.

[0068] Both the second and third bending control components are sleeves with internal threads, and both the second and third sliders are annular cylinders with external threads. The second bending control component is sleeved on the outside of the second slider and threadedly connected to the second slider so that the second slider can be moved axially along the handle 200 when the second bending control component is rotated. The third bending control component is sleeved on the outside of the third slider and threadedly connected to the third slider so that the third slider can be moved axially along the handle 200 when the third bending control component is rotated.

[0069] In this embodiment, the operator can control the deformation and bending of the first tube segment 110 and the second tube segment 120 by using the second bending control component and the third bending control component, respectively.

[0070] It should be noted that the specific implementation process of the first operating mechanism and the second operating mechanism can be found in the above embodiments, and will not be repeated here.

[0071] In some embodiments, the catheter body 100 employs segments with varying hardness. Specifically, the first segment 110 has a lower hardness than the second segment 120, which in turn has a lower hardness than the third segment 130. This progressively increasing hardness design makes the first and second segments 110 and 120 easier to bend and deform during operation. By reducing the hardness of the first two segments, the surgeon can more flexibly manipulate the distal end of the catheter, enabling it to smoothly pass through complex vascular pathways and accurately reach the target location. Simultaneously, the third segment 130 maintains a higher hardness, providing necessary support and stability for the catheter. This ensures that the overall shape of the catheter and the accurate position of the electrode assembly 400 are effectively maintained during surgical procedures, balancing the catheter's flexibility and rigidity and improving the convenience and safety of the surgical operation.

[0072] In some embodiments, see Figures 9 to 14 The electrode assembly 400 includes multiple substrate groups 410 and electrodes 420. The operating mechanism also includes an electrode control assembly 540, see [link to details]. Figure 5 The multiple substrate groups include two or more substrates 411 arranged sequentially along the circumference of the inner tube 300. Each substrate 411 connects the inner tube 300 to the first tube body segment 110 of the tube body 100. The substrates 411 are deformable. Each substrate 411 includes at least a first segment and a second segment connected together, with a first connection point between the first and second segments. The first connection points in the same substrate group 410 are in contact to form a connecting portion. An electrode 420 is at least disposed at the connecting portion. An electrode control assembly 540 is disposed on the handle 200 and connected to the inner tube 300. It controls the movement of the inner tube 300 relative to the tube body 100, thereby causing the substrates 411 to deform and adjust the state of the electrode assembly 400.

[0073] The substrate 411 can have a certain degree of elasticity and can be composed of nickel-titanium alloy and composite polymer materials, or it can be composed entirely of polymer materials. Multiple electrodes 420 are arranged on the substrate 411. The electrode 420 can be made of platinum-iridium alloy or gold. The distal end of the inner tube 300 is connected to the distal end of the electrode assembly 400, and the proximal end of the inner tube 300 passes through the guide wire cavity 230 of the handle 200 and is connected to the electrode control component 540. (See also...) Figure 5 and Figure 6 By operating the electrode control component 540, the following can be achieved: Figures 10 to 13 The electrode assembly 400 can switch between the first, second, third and fourth states as shown, or it can be fixed in any intermediate state to adapt to the ablation requirements of different ablation sites. Figure 14 This is a schematic diagram of electrode 420 during ablation of pulmonary vein a.

[0074] In this embodiment, the electrode assembly 400 can be stopped and fixed in any state. Specifically, a certain frictional force can be set between the inner tube 300 and the tube body 100. This frictional force can stably fix the electrode assembly 400 in the stopped position. Of course, a locking component can also be applied to the electrode control assembly 540 or a frictional force can be applied to the inner tube 300. This embodiment does not limit its specific structure.

[0075] In practical implementation, the electrode 420 can be designed with different combinations of electrode spacing and polarity according to actual needs. Each electrode 420 can be controlled to discharge independently. The conductor path used to connect the electrode 420 can withstand high voltage, such as 4000V. Once the target catheter is positioned, the connector 600 can be connected to the pulse emission device to effectively transmit high-voltage pulse energy to the target tissue through the remote electrode 420 to achieve effective ablation. At the same time, this embodiment can also be connected to instruments with the same function, such as a multichannel instrument and a three-dimensional mapping host. The electrode 420 can simultaneously record and transmit electrical signals in real time, display the potential of the part where the electrode is attached in real time, and perform three-dimensional mapping to help the operator judge the ablation situation.

[0076] In this embodiment, the electrode 420 can also be disposed on the substrate 411 at other locations besides the connecting portion.

[0077] For the specific implementation process of the electrode assembly 400 in this embodiment, please refer to the patent with publication number CN114917021A. The structure and working state of the electrode assembly 400 in this patent include all the structures and states in that patent, and are applicable to this embodiment.

[0078] In some embodiments, see Figure 5 and Figure 6 The electrode control assembly 540 includes a push-pull button 541. The handle 200 has a sliding groove 210, and the push-pull button 541 is movably disposed in the sliding groove 210 and can stop and be fixed at any position within the sliding groove 210; one end of the push-pull button 541, located inside the sliding groove 210, is connected to the inner tube 300. Specifically, the inner tube 300 passes through the guide wire cavity 230 of the handle 200, and the push-pull button 541 can be connected to the inner tube 300 via a Luer component.

[0079] The electrode assembly 400 can be switched between a first state and a second state by pushing and pulling the push-pull key 541. When the push-pull key 541 is at the far end, the electrode assembly 400 is in the first state (shuttle-shaped) (see...). Figure 10 and Figure 11 When the push-pull button 541 is in the proximal position, the electrode assembly 400 is in the second state (flower shape) (see...). Figure 12 and Figure 13 ).

[0080] See Figure 17 The second tube segment 120 and the third tube segment 130 are also equipped with a first lead channel 150. Each electrode 420 is individually connected to a lead and then connected to a connector 600 through the first lead channel 150. After the electrode 420 is connected to ablation mapping and other equipment through the connector 600, it can release pulse energy to the target tissue. At the same time, it can perform intracardiac electrical signal mapping and pacing stimulation. The operator can perform real-time cardiac electrophysiological examinations through the catheter, including functions such as 3D modeling. The basket-like structure of the electrode assembly 400 hinges to each other, ensuring that the electrodes 420 can be evenly distributed in different configurations. During ablation, short circuits will not occur between adjacent electrodes 420, thus avoiding related safety issues.

[0081] Understandable, see [link / reference] Figure 3 and Figure 16 The first tube segment 110 may encapsulate a magnetic sensor 111, which may be one, two, or more. The second tube segment 120 and the third tube segment 130 also have a second wire channel 170, through which the magnetic sensor 111 connects to the connector 600 at the near end. Tube electrodes 112 (which may be annular or similar in shape) may also be arranged on the outer surface of the first tube segment 110. The tube electrodes 112 also connect to the connector 600 at the near end through the first wire channel 150, primarily for electro-positioning-assisted three-dimensional mapping.

[0082] In this embodiment, the connector 600 at the distal end of the handle 200 is connected to the electrode 420 on the electrode assembly 400, the tube electrode 112 on the tube body 100, and the magnetic sensor 111 in the first tube body segment 110 via wires. The connector 600 is then connected to the ablation or mapping host to achieve energy transmission and perform ablation, three-dimensional mapping, or pacing stimulation on the target location.

[0083] See Figure 3 , 15 16. In some embodiments, an intermediate tube 900 may be provided between the tube body 100 and the inner tube 300, and a side branch 700 may be provided at the tail of the handle 200. Figure 1 The right side (shown) has a branch 700 connected to a three-way assembly 220 (e.g., a three-way valve) in the handle 200, see [link / reference]. Figure 6 and Figure 15The three-way assembly 220 consists of a three-way front cover 221, a three-way rear cover 222, and an O-ring 223. The intermediate tube 900 is fixed inside the three-way front cover 221 and sealed with glue. The inner tube 300 passes through the intermediate tube 900 and the O-ring 223 and connects to the guidewire lumen. During the operation, the surgeon can perform liquid irrigation through the side branch 700. The liquid enters from the three-way assembly 220 of the side branch 700, then enters the three-way assembly 220 through the liquid inlet A of the three-way rear cover 222, then enters the gap between the intermediate tube 900 and the inner tube 300, and flows out from the electrode assembly 400 at the distal end of the intermediate tube 900.

[0084] Obviously, those skilled in the art can make various modifications and variations to this application without departing from the spirit and scope of this application. Therefore, if such modifications and variations fall within the scope of the claims of this application and their equivalents, this application also intends to include such modifications and variations.

Claims

1. A pulsed electric field ablation catheter, characterized in that, include: The tube body comprises a first tube body segment, a second tube body segment, and a third tube body segment connected in sequence, wherein the second tube body segment is deformable; The handle is connected to the third tube section; The inner tube is fitted onto the tube body and can move along the axial direction of the tube body; An electrode assembly connects the inner tube and the first tube body segment. When the inner tube moves relative to the tube body, the electrode assembly can deform to adjust the position of the electrodes in the electrode assembly. An operating mechanism, disposed on the handle and connected to the second tube section and the inner tube, is used to control the deformation of the second tube section to cause bending, and to control the movement of the inner tube relative to the tube body, which can stop at any position within the range of movement.

2. The pulsed electric field ablation catheter according to claim 1, characterized in that, The hardness of the second tube section is lower than that of the first tube section and the third tube section.

3. The pulsed electric field ablation catheter according to claim 1, characterized in that, The first tube section is deformable; The operating mechanism is used to simultaneously control the deformation and bending of the first tube segment and the second tube segment; or, The operating mechanism is used to control the first tube segment and the second tube segment to deform and bend independently.

4. The pulsed electric field ablation catheter according to claim 3, characterized in that, The hardness of the first tube section is lower than that of the second tube section; The hardness of the second tube section is lower than that of the third tube section.

5. The pulsed electric field ablation catheter according to claim 3, characterized in that, The operating mechanism includes: A first connecting mechanism is connected to the first tube segment and the second tube segment; A first bending control component is disposed on the outer surface of the handle and connected to the first connecting mechanism, and is used to apply force to the first tube segment and the second tube segment through the first connecting mechanism to cause the first tube segment and the second tube segment to bend.

6. The pulsed electric field ablation catheter according to claim 5, characterized in that, The first connecting mechanism includes: A first slider is slidably connected to the handle along the axial direction of the handle; The first traction line has its distal end connected to the first tube segment and its proximal end connected to the first slider. The distal end and proximal end of the first traction line are also connected to the second tube segment. The first bending control component is connected to the first slider and is used to control the first slider to slide relative to the handle in order to apply tension to the first traction line, thereby causing the first tube segment and the second tube segment to deform and bend.

7. The pulsed electric field ablation catheter according to claim 3, characterized in that, The operating mechanism includes: The second connecting mechanism is connected to the first tube section; The second bending control component is disposed on the outer surface of the handle and connected to the second connecting mechanism, and is used to apply force to the first tube segment through the second connecting mechanism so that the first tube segment deforms and bends. The third connecting mechanism is connected to the second tube section; The third bending control component is disposed on the outer surface of the handle and connected to the third connecting mechanism, and is used to apply force to the second tube segment through the third connecting mechanism to cause the second tube segment to deform and bend.

8. The pulsed electric field ablation catheter according to claim 7, characterized in that, The second connecting mechanism includes a second slider and a second traction line, and the third connecting mechanism includes a third slider and a third traction line; The second slider and the third slider are arranged sequentially along the axial direction of the handle and are slidably connected to the handle; The distal end of the second traction line is connected to the first tube segment, the proximal end of the second traction line is connected to the second slider, the distal end of the third traction line is connected to the second tube segment, and the proximal end of the third traction line is connected to the third slider. The second bending control component is connected to the second slider and is used to control the second slider to slide relative to the handle in order to apply tension to the second traction line; the third bending control component is connected to the third slider and is used to control the third slider to slide relative to the handle in order to apply tension to the third traction line.

9. The pulsed electric field ablation catheter according to claim 6 or claim 8, characterized in that, The first bending control component is a sleeve with internal threads, and the first slider is an annular cylinder with external threads. The first bending control component is sleeved on the outside of the first slider and threadedly connected to the first slider, so that when the first bending control component is turned, it can drive the first slider to move axially along the handle; or, Both the second and third bending control components are sleeves with internal threads, and both the second and third sliders are annular cylinders with external threads. The second bending control component is sleeved on the outside of the second slider and threadedly connected to the second slider, so that when the second bending control component is rotated, the second slider can be moved along the axial direction of the handle. The third bending control component is sleeved on the outside of the third slider and threadedly connected to the third slider, so that when the third bending control component is screwed on, the third slider can be moved along the axial direction of the handle.

10. The pulsed electric field ablation catheter according to claim 1, characterized in that, The electrode assembly includes: Multiple base groups, each base group comprising two or more bases arranged sequentially along the circumference of the inner tube, wherein the bases connect the inner tube and the first tube body segment of the tube body, the bases are deformable, and each base includes at least a first segment and a second segment connected together, wherein the first segment and the second segment have a first connection point, and the first connection point in the same base group is contacted to form a connecting part; An electrode, wherein the electrode is at least disposed in the connecting portion; The operating mechanism also includes: An electrode control assembly, disposed on the handle and connected to the inner tube, is used to control the movement of the inner tube relative to the tube body, thereby causing the substrate to deform to adjust the state of the electrode assembly.

11. The pulsed electric field ablation catheter according to claim 10, characterized in that, The electrode control assembly includes: The push-pull button has a sliding groove on the handle, and the push-pull button is movably disposed in the sliding groove and can stop at any position in the sliding groove; one end of the push-pull button located inside the push-pull groove is connected to the inner tube.

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