Head electrode assembly and ablation catheter

Abstract

This application relates to a head electrode assembly and an ablation catheter. The head electrode assembly is disposed at the distal end of the catheter assembly of the ablation catheter. The head electrode assembly includes a tip, a pressure sensor, and a limiting member. The tip has a receiving space extending axially to the proximal end face of the tip, and the tip is used to release ablation energy. The pressure sensor is located in the receiving space and at least axially abuts against the tip to detect external pressure on the tip. The pressure sensor is configured to sense at least one of the axial pressure and radial pressure on the tip. The limiting member is disposed at the tip, and the limiting member and the tip are configured to at least jointly limit the axial displacement of the pressure sensor. The pressure sensor can sense the contact pressure between the tip and the tissue, reducing the occurrence of excessive contact force between the tip and the tissue, thereby reducing tissue damage and lowering the risk of damage to the atrial wall and adjacent tissues; it also helps to reduce the occurrence of insufficient contact force between the tip and the tissue, leading to poor contact between the tip and the tissue.

Description

Technical Field

[0001] This application relates to the field of medical device technology, such as cardiac electrophysiology, and specifically to head electrode assemblies and ablation catheters. Background Technology

[0002] With the development of medical technology, catheter ablation has gradually become an important treatment for atrial fibrillation, and pulmonary vein isolation (PVI) has become one of the standard procedures for catheter ablation of atrial fibrillation.

[0003] Because the posterior atrial wall histology and pulmonary veins share the same embryonic lineage, it is a potential source of atrial fibrillation. Adding posterior atrial wall isolation during pulmonary vein isolation can reduce or even prevent atrial fibrillation recurrence. However, during posterior atrial wall ablation, excessive contact force between the head electrode assembly and the tissue to be ablated can easily cause tissue damage, while insufficient contact force can lead to poor adhesion between the head electrode and the tissue, affecting the ablation effect. Summary of the Invention

[0004] In one embodiment, a head electrode assembly is provided, disposed at the distal end of an ablation catheter, the head electrode assembly comprising:

[0005] An end cap, wherein an accommodating space is provided within the end cap, the accommodating space extending axially to the proximal end face of the end cap, the end cap being used to release ablation energy; and

[0006] A pressure sensor is located in the accommodating space, and the pressure sensor abuts against the end at least axially to detect the external pressure on the end.

[0007] The pressure sensor is configured to sense at least one of the axial pressure and radial pressure applied to the end.

[0008] A limiting member is provided at the end, and the limiting member and the end are configured to at least jointly limit the axial displacement of the pressure sensing element.

[0009] In one embodiment, this application provides a head electrode assembly disposed at the distal end of an ablation catheter. The head electrode assembly includes a tip, a pressure sensor, and a limiting member. The tip has a receiving space extending axially to the proximal face of the tip, and the tip is used to release ablation energy. The pressure sensor is located within the receiving space and at least axially abuts against the tip to detect external pressure on the tip. The pressure sensor is configured to sense at least one of axial and radial pressure on the tip. The limiting member is disposed at the tip, and the limiting member and the tip are configured to at least jointly limit the axial displacement of the pressure sensor. The pressure sensor, located inside the tip, can sense the contact pressure between the tip and tissue, which helps reduce excessive contact force between the tip and tissue, thereby reducing tissue damage and lowering the risk of damage to the atrial wall and adjacent tissues. It also helps reduce insufficient contact force between the tip and tissue, which could lead to poor contact between the tip and tissue.

[0010] In one embodiment, this application also provides an ablation catheter, including a head electrode assembly, a catheter assembly, and an ablation component. The catheter assembly includes a control tube and a main tube, with the control tube inserted within the main tube and its distal end located on one side of the distal end of the main tube. The ablation component is located at the distal end of the main tube, with its proximal end connected to the main tube and its distal end connected to the distal end of the control tube. The ablation component has an extended shape and a contracted shape, with the radial dimension of the extended shape being larger than that of the contracted shape. The head electrode assembly is located at the distal end of the ablation component. The ablation component includes multiple branch tubes, which are spaced apart circumferentially along the ablation component to form an enclosed space. At least one ablation electrode is provided on at least one branch tube, and the head electrode assembly is located at the distal end of the ablation component. One of the control tube and the main tube is axially movable relative to the other, allowing the ablation component to switch between the extended and contracted shapes. The operator can adjust the distance between the distal ends of the control tube and the main tube, and adjust the outline diameter of the extended shape of the branch tubes. The shorter the distance between the distal ends of the control catheter and the distal ends of the main catheter—for example, when the distal ends of the control catheter and the distal ends of the main catheter are nearly in contact or abutting—the greater the extent of branch tube expansion (i.e., the larger the diameter of the expanded shape), and the larger the diameter of the ablation range formed by multiple ablation components. Therefore, the operator can adjust the distance between the distal ends of the control catheter and the distal ends of the main catheter according to the ablation requirements, thereby adjusting the diameter of the ablation range formed by multiple ablation components, i.e., adjusting the radial dimensions of the ablation components. This allows for the ablation of vessels of different diameters (such as pulmonary veins), which helps to improve the applicability of the ablation catheter. Attached Figure Description

[0011] Figure 1 This is a schematic diagram of the ablation catheter provided in one embodiment of this application.

[0012] Figure 2 This is a schematic diagram of the head electrode assembly provided in one embodiment of this application. Figure 1 .

[0013] Figure 3 This is a schematic diagram of the head electrode assembly provided in one embodiment of this application. Figure 2 .

[0014] Figure 4 This is a schematic diagram of the end structure provided in one embodiment of this application. Figure 1 .

[0015] Figure 5 This is a schematic diagram of the end structure provided in one embodiment of this application. Figure 2 .

[0016] Figure 6 This is a schematic diagram of the structure of the limiting member provided in one embodiment of this application.

[0017] Figure 7 This is a schematic diagram of atrial posterior wall ablation performed according to one embodiment of this application.

[0018] Figure 8 This is a schematic diagram of the ablation catheter provided in one embodiment of the present application when performing ablation on the pulmonary vein orifice and vestibule.

[0019] Figure 9 This is a schematic diagram of the ablation electrode discharge mode when the electrode assembly without a head is provided in one embodiment of this application.

[0020] Figure 10 This is a schematic diagram of the ablation electrode discharge pattern after adding a head electrode assembly in one embodiment of this application.

[0021] Explanation of reference numerals in the attached figures:

[0022] 100-ablation catheter;

[0023] 10-head electrode assembly;

[0024] 1-End; 11-Accommodating space; 111-Accommodating cavity; 111a-Second inner cavity; 12-Limiting ring block; 121-Limiting channel; 122-Second abutting surface; 123-Limiting groove; 13-First abutting surface; 14-Positioning ring block; 141-First inner cavity; 142-Third abutting surface; 15-First gap; 16-Second gap; 17-Third gap;

[0025] 2-Pressure sensing element;

[0026] 3-Limiting component; 31-Connecting part; 32-Limiting part; 321-Limiting body; 322-Limiting protrusion;

[0027] 20-Catheter assembly; 201-Control tube; 202-Main tube;

[0028] 30-Ablation assembly; 301-Branch tube; 302-Enclosed space; 303-Ablation electrode; 304-Headpiece;

[0029] 40 - Cushioning pad;

[0030] 50 - Calibration electrode;

[0031] 60 - Coaxial detection assembly; 601 - Magnetic positioning component; 602 - Reference electrode component. Detailed Implementation

[0032] It should be understood that the examples and illustrations in this application are for illustrative purposes, and deviations and variations can be constructed and deployed based on the teachings of this application without departing from the scope of this application. Before detailing at least one embodiment of this application, it should be understood that this application is not necessarily limited to the detailed configuration and arrangement of the components and / or methods set forth in the following description and / or illustrated in the drawings and / or embodiments. This application can have other embodiments or can be practiced or implemented in different ways.

[0033] Unless otherwise defined, all technical and / or scientific terms used in this application have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains. While similar or equivalent methods and materials to those described in this application may be used to practice or test embodiments of this application, exemplary methods and / or materials are described below. In the event of any conflict, the specification (including definitions) of this application shall prevail. Furthermore, these materials, methods, and embodiments are illustrative only and are not intended to impose necessary limitations.

[0034] In the description of this application, unless otherwise expressly specified and limited, the terms "connected," "linked," and "fixed" 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 based on the specific circumstances. Furthermore, the terms "first," "second," etc., are used merely for descriptive distinction and have no special meaning.

[0035] In this application, the distal end refers to the end of the ablation catheter and at least some of the components constituting the ablation catheter that are exemplary away from the operator during use (or, the distal end refers to the end of the ablation catheter and at least some of the components constituting the ablation catheter that are exemplary in contact with / intervene in the biological tissue when used on a living organism), and the proximal end refers to the end of the ablation catheter and at least some of the components constituting the ablation catheter that are exemplary close to the operator during operation (or, the proximal end refers to the end of the ablation catheter and at least some of the components constituting the ablation catheter that are exemplary in contact with / intervene in the biological tissue when used on a living organism compared to the distal end).

[0036] In this application, axial direction refers to the direction of the axis of the ablation catheter 100, radial direction refers to the direction perpendicular to the axial direction and containing the radius or diameter, and circumferential direction refers to the direction perpendicular to and surrounding the axial direction.

[0037] See Figure 1 , Figure 1 A schematic diagram of the structure of an ablation catheter 100 provided in one embodiment of this application is shown.

[0038] like Figure 1 As shown, this embodiment provides an ablation catheter 100, which includes a catheter assembly 20 and a head electrode assembly 10. The head electrode assembly 10 is disposed at the distal end of the catheter assembly 20. The head electrode assembly 10 is used to contact the site to be ablated, and point ablation is achieved by contacting the head electrode assembly 10 with the site to be ablated. For example, point ablation can be used for ablation of locations such as the posterior wall of the atrium.

[0039] In some embodiments, the catheter assembly 20 includes a control tube 201 and a main tube 202, the control tube 201 being inserted into the main tube 202, the distal end of the control tube 201 being located on one side of the distal end of the main tube 202, and the control tube 201 being movable along the axial direction of the main tube 202. The ablation catheter 100 also includes an ablation component 30. The ablation component 30 is located at the distal end of the main pipe 202. The proximal end of the ablation component 30 is connected to the main pipe 202, and the distal end of the ablation component 30 is connected to the distal end of the control tube 201. The ablation component 30 has an extended form and a contracted form, with the radial dimension of the extended form being larger than that of the contracted form. The head electrode assembly 10 is located at the distal end of the ablation component 20. The ablation component 20 includes a plurality of branch tubes 301, which are distributed circumferentially around the ablation component 20 to form an enclosed space 302. At least one ablation electrode 303 is provided on at least one branch tube 301. The head electrode assembly 10 is located at the distal end of the ablation component 30. One of the control tube 201 and the main pipe 202 is axially movable relative to the other, so that the ablation component 30 can switch between the extended form and the contracted form.

[0040] The operator can adjust the distance between the distal ends of the control tube 201 and the distal ends of the main tube 202 to adjust the diameter of the deployed branch tube 301. The shorter the distance between the distal ends of the control tube 201 and the main tube 202, for example, when the distal ends of the control tube 201 and the main tube 202 are close to contact or abutting each other, the greater the expansion of the branch tube 30 (i.e., the larger the diameter of the deployed shape), and the larger the diameter of the ablation range formed by the multiple ablation components 30. Therefore, the operator can adjust the distance between the distal ends of the control tube 201 and the main tube 202 according to the ablation requirements to adjust the diameter of the ablation range formed by the multiple ablation components 30, that is, to adjust the radial dimension of the ablation components 30, thereby meeting the ablation requirements of blood vessels of different diameters (such as pulmonary veins), which is beneficial to improving the applicability of the ablation catheter 100.

[0041] The ablation component 30 utilizes ablation energy to ablate tissue. The ablation energy can be pulse energy, radio frequency energy, ultrasound energy, or other suitable ablation energy.

[0042] In some embodiments, when the ablation catheter 100 is used for interventional procedures on blood vessels of different diameters, the operator inserts the distal end of the ablation catheter 100 into the human body. During the procedure, the diameter of the ablation component 30 can be adjusted to meet the ablation needs of blood vessels of different diameters without the need to remove and replace the ablation catheter 100. This reduces the number of steps involved in the procedure, such as removal, replacement, and insertion, and also reduces the number of intervention steps involving surgical instruments in the body, shortens the procedure time, and improves the safety and efficiency of the ablation process.

[0043] Furthermore, in some embodiments, when ablation is performed on the posterior wall of the atrium via the ablation catheter 100, since the ablation area of ​​the posterior wall of the atrium is relatively large, by increasing the ablation radius of multiple ablation components 30, the occurrence of ablation leaks can be reduced, and selective discharge can also be performed, which is beneficial to improving ablation efficiency.

[0044] In some embodiments, the number of branch tubes 301 is two, three, four, five, six, seven, eight, nine, ten, eleven, twelve, or any other suitable number. The branch tubes 301 can be evenly or non-uniformly distributed circumferentially around the control tube 201. Exemplarily, there are five branch tubes 301, spaced apart around the axis of the control tube 201, and evenly arranged circumferentially. Corresponding to the branch tubes 301, there are at least five ablation components 30, with at least one ablation component 30 disposed on each branch tube 301. Exemplarily, the ablation components 30 are disposed on the branch tubes 301 so that, as the control tube 201 moves along the distal end of the main tube 202, the diameter of the ablation component 30 gradually increases as the middle position of the branch tube 301 bulges outward, which is beneficial for increasing the ablation range that the ablation component 30 can ablate.

[0045] In some embodiments, the proximal ends of the plurality of branch pipes 301 may be an integral structure, such as being integrally cut from a single pipe, or the proximal ends of the plurality of branch pipes 301 may be connected into an integral structure by means of bonding, welding, or other methods. The proximal ends of the plurality of branch pipes 301 and the main pipe 202 may be bonded or welded, or both may be bonded and welded simultaneously. The distal ends of the plurality of branch pipes 301 may be connected to the head electrode assembly 10 by means of bonding or welding, or other methods.

[0046] Optionally, the main pipe 202 may have a single axial cavity or a central cavity (not shown in the figure), and the control pipe 201 may be disposed in the axial cavity or the central cavity. Depending on the requirements, the main pipe 202 may also have multiple cavities to accommodate draw wires, guide wires, electrical wires, and other wires and / or pipes that may be required in a particular application.

[0047] In some embodiments, along the axial direction of the control pipe 201, different distances between the distal end of the control pipe 201 and the distal end of the main pipe 202 result in different shapes for the branch pipe 301. These distances include a first position, a second position, and a third position. When the control pipe 201 is in the first position, the branch pipe 301 remains or nearly remains in a straight state, which is a contracted shape. When the control pipe 201 is in the second position, the branch pipe 301 has an arcuate bulge at the middle position along the axial direction, making it cage-like, which is one type of extended shape. When the control pipe 201 is in the third position, the branch pipe 301 has an arcuate bulge at the middle position along the axial direction to its maximum diameter, making it petal-shaped, which is another type of extended shape.

[0048] In some embodiments, as the distal end of the control tube 201 gradually approaches the distal end of the main tube 202, the shape of the branch tube 301 gradually changes from a straight line to a cage-like and / or petal-like shape. The ablation radius formed by the multiple ablation components 30 gradually increases, thereby adapting to the ablation needs of different regions of the atrium. This is beneficial for expanding the applicability of the ablation catheter 100 and improving ablation efficiency. For example, when performing large-area ablation such as on the posterior wall of the atrium, the control tube 201 can be controlled to a third position, making the branch tube 301 present a petal-like structure, keeping the multiple ablation components 30 within the maximum ablation range, thereby expanding the ablation area of ​​the ablation catheter 100 and improving ablation efficiency.

[0049] like Figure 1 As shown, Figure 1The control pipe 201 is in the second position, and the branch pipe 301 is cage-shaped. When the distal end of the control pipe 201 moves axially from the second position away from the main pipe, the axial dimension of the cage-shaped branch pipe 301 gradually increases (i.e., the distance between the distal end of the control rod and the distal end of the main pipe gradually increases), and the radial dimension of the branch pipe 301 gradually decreases. When the control pipe 201 moves to the first position, the branch pipe 301 changes from a cage shape to a straight shape. When the control pipe 201 moves axially from the second position towards the distal end of the main pipe, the axial dimension of the cage-shaped branch pipe 301 gradually decreases (i.e., the distance between the distal end of the control rod and the distal end of the main pipe gradually decreases), and the radial dimension of the branch pipe 301 gradually increases. When the control pipe 201 moves to the third position, the branch pipe 301 changes from a cage shape to a petal shape.

[0050] In some embodiments, the electrode polarities of the head electrode assembly 10 and the ablation assembly 30 are opposite, thereby creating a current loop for tissue ablation.

[0051] For example, the ablation energy is a pulsed electric field, with the head electrode assembly 10 as the positive electrode and the ablation assembly 30 as the negative electrode. When the ablation catheter 100 is performing a treatment procedure, the current loop of the ablation catheter 100 is from the head electrode assembly 10, through the target tissue, to the ablation assembly 30, thereby forming an ablation pulsed electric field for the target tissue. The head electrode assembly 10 and the ablation assembly 30 constitute orthogonal electric fields, increasing the ablation area and reducing the likelihood of missed ablation points when ablating the posterior wall of the atrium. Simultaneously, selective discharge is possible, improving ablation efficiency. Setting the ablation assembly 30 as the negative electrode helps to minimize the current path from the head electrode assembly 10 to the ablation assembly 30, ensuring that most of the current acts on the target tissue (such as myocardial tissue) between the head electrode assembly 10 and the ablation assembly 30, rather than diffusing to adjacent or more distant non-target tissues (such as healthy tissue).

[0052] like Figure 2 and Figure 3 As shown, in at least one embodiment, the head electrode assembly 10 includes a head 1 and a pressure sensor 2. The head 1 has a receiving space 11 extending axially to the proximal end face of the head 1. The head 1 is used to release ablation energy. The pressure sensor 2 is located in the receiving space 11 and abuts against the head 1 at least axially to detect external pressure on the head 1. The pressure sensor 2 is configured to sense at least one of axial pressure and radial pressure on the head 1. A limiting member 3 is provided on the head 1, and the limiting member 3 and the head 1 are configured to at least jointly limit the axial displacement of the pressure sensor 2.

[0053] The pressure sensor 2 is located inside the end 1 and can sense the contact pressure between the end 1 and the tissue. This helps to reduce the occurrence of excessive contact force between the end 1 and the tissue, thereby reducing tissue damage and lowering the risk of damage to the atrial wall and adjacent tissues. It also helps to reduce the occurrence of insufficient contact force between the end 1 and the tissue, which would lead to poor contact between the end 1 and the tissue.

[0054] For example, by using the sensing results of the pressure sensor 2, the operator can determine the contact force between the tip 1 and the tissue, thereby reducing the damage to the atrium caused by the tip 1 when ablating the atrial wall.

[0055] In one embodiment, the pressure sensor 2 is configured to sense the axial and / or radial pressure on the end cap 1, enabling it to detect pressure changes at the distal end and / or radial direction of the end cap 1. This ensures that the pressure at any point on the distal end or circumferentially oriented end cap 1 against the tissue can be sensed by the pressure sensor 2, reducing the unavoidable tissue damage caused by excessive radial pressure at the end cap in related technologies. The pressure sensor 2, by sensing the pressure between the end cap 1 and the atrial wall and adjacent tissues, helps reduce the risk of damage during the ablation process, improves the effectiveness of ablation, reduces the risk of poor contact due to insufficient pressure, and ultimately improves ablation efficiency.

[0056] For example, when performing circumferential ablation on the pulmonary vein, the pressure sensed by the pressure sensor 2 can be used to determine whether the end 1 is in contact with the pulmonary vein. If there is contact, the position of the ablation catheter 100 can be adjusted to improve the fit of the ablation electrode 303 on the branch tube 301, which is beneficial to improve the integrity or closed loop of the circumferential ablation.

[0057] In at least one embodiment, when performing point ablation or streaking ablation on the posterior wall of the atrium, the pressure sensed by the pressure sensor 2 can determine the contact force between the tip 1 and the tissue. This helps to reduce the occurrence of excessive contact force between the tip 1 and the tissue, thereby reducing tissue damage. It also helps to reduce the occurrence of insufficient contact force between the tip 1 and the tissue, leading to poor adhesion between the tip 1 and the tissue. For example, since the posterior wall of the atrium is anatomically adjacent to the esophagus, the ablation process may cause esophageal damage. Sensing the pressure of the tip 1 by the pressure sensor 2 can reduce the risk of esophageal damage.

[0058] In at least one embodiment, the pressure sensing element 2 is a capacitive pressure sensor. Compared with the high price of fiber optic pressure sensors used in related technologies, or the potential for inconsistent processing due to the use of multiple strain gauges as monitoring elements, capacitive pressure sensors are cheaper, have lower requirements for processing accuracy, and can stably detect axial and radial pressure changes.

[0059] During operation, the parameters detected by the capacitive pressure sensor change, and the operator can analyze the fit through the back-end analysis module to calculate the magnitude of the tissue contact force.

[0060] Optionally, end 1 is a head electrode, which can be a positive electrode or a negative electrode.

[0061] Optionally, end 1 is a platinum-iridium alloy, gold, or stainless steel plated part.

[0062] In at least one embodiment, the distal end face of the pressure sensor 2 abuts against the end head 1 in the axial direction, and the limiting member 3 is disposed at the proximal end of the pressure sensor 2. The limiting member 3 and the end head 1 are configured to jointly limit the axial displacement of the pressure sensor 2. At this time, the limiting member 3 is used to limit the pressure sensor 2, thereby improving the stability of the pressure sensor 2 in the accommodating space 11, reducing the risk of detachment, and also helping to improve the accuracy of the pressure sensor 2 in sensing the axial pressure of the end head 1. The limiting member 3 is supported on the proximal end of the pressure sensor 2, so that the pressure sensor 2 is limited in the accommodating space 11, realizing the assembly and implementation of the head electrode assembly 10.

[0063] In some embodiments, such as Figure 2 and Figure 3 As shown, by setting detailed structures in the accommodating space 11, the end 1 can simultaneously limit the axial and radial displacement of the pressure sensing element 2, that is, the radial direction of the pressure sensing element 2 contacts or abuts against the inner wall of the accommodating space 11, making the radial pressure of the end 1 easier to be detected by the pressure sensing element 2, which is beneficial to improving the sensitivity of the pressure sensing element 2 in detecting radial pressure changes.

[0064] like Figures 2-5 In some embodiments, the end 1 is provided with a limiting ring block 12, which is located at the proximal end of the accommodating space 11. The limiting ring block 12 is fixed to the inner peripheral wall of the end 1, so that the accommodating space 11 includes an accommodating cavity 111 and a limiting channel 121 that are interconnected from the distal end to the proximal end. The limiting channel 121 is the inner cavity of the limiting ring block 12. Along the radial direction of the end 1, the radial dimension of the accommodating cavity 111 is larger than the radial dimension of the limiting channel 121, so that a first abutting surface 13 and a second abutting surface 122 are formed in the end 1. The first abutting surface 13 is the inner wall surface of the distal end of the end 1 and is located at the distal end of the accommodating cavity 111. The second abutting surface 122 is the distal end surface of the limiting ring block 12. The pressure sensing element 2 is located in the accommodating cavity 111, and the first abutting surface 13 abuts against the distal end surface of the pressure sensing element 2. The limiting element 3 is provided on the limiting ring block 12. The limiting ring block 12 confines the limiting member 3 within the accommodating cavity 111, which helps to improve structural stability.

[0065] The axial positioning of the pressure sensor 2 and the limiting member 3 is achieved by the first contact surface 13 and the second contact surface 122, which helps to improve the positioning stability of the pressure sensor 2, enabling it to detect axial pressure changes more accurately, and also helps to improve the stability of the pressure sensor 2 in the accommodating space 11.

[0066] In one embodiment, such as Figures 2-3 , Figure 6 As shown, the limiting member 3 includes a connecting portion 31 and a limiting portion 32. The connecting portion 31 passes through the limiting channel 121, and the limiting portion 32 is connected to the distal end of the connecting portion 31 and is located in the receiving cavity 111. The distal end of the limiting portion 32 abuts against the pressure sensor 2, and the proximal end of the limiting portion 32 abuts against the second abutment surface 122. The limiting portion 32 is used to limit the pressure sensor 2 and maintain the stability of the axial displacement of the pressure sensor 2. The connecting portion 31 passing through the limiting channel 121 helps to improve the stability of the position of the limiting member 3 and the stability of the limiting member 3 in limiting the pressure sensor 2, thereby improving the sensitivity and accuracy of the pressure sensor 2 in detecting axial and radial pressure changes at the end 1.

[0067] Optionally, the connecting part 31 is fixed to the conduit assembly 20 by adhesive bonding.

[0068] In one embodiment, the limiting ring block 12 is provided with at least one limiting groove 123, which radially penetrates the inner peripheral wall of the limiting ring block 12. The limiting part 32 includes a limiting body 321 and at least one limiting protrusion 322 disposed on the outer periphery of the limiting body 321. Each limiting protrusion 322 corresponds to a limiting groove 123. The radial dimension of the limiting body 321 is not greater than the radial dimension of the limiting channel 121, and the radial dimension of the limiting protrusion 322 is greater than the radial dimension of the limiting channel 121. The radial dimension of the limiting protrusion 322 is the same as the radial dimension of the limiting groove 123. The limiting part 32 abuts against the second abutment surface 122 through the limiting protrusion 322. The limiting protrusion 322 and the limiting groove 123 are used to realize the installation and positioning of the limiting member 3, which facilitates the limiting part 32 to enter the receiving cavity 111 through the limiting channel 121 to limit the pressure sensing member 2.

[0069] For example, the limiting protrusion 322 and the limiting groove 123 are arc-shaped structures arranged in the circumferential direction. Along the circumferential direction of the end 1 or the limiting part 32, the arc corresponding to the limiting protrusion 322 and the limiting groove 123 is 60°-90° to ensure the stability of the limiting part 32 in the second inner cavity 111a.

[0070] There are multiple limiting protrusions 322, which are spaced apart circumferentially. When assembling the limiting part 32, the limiting protrusions 322 can be aligned with the limiting grooves 123. The limiting protrusions 322 are pushed into the limiting grooves 123 axially, and the limiting protrusions 322 are pushed further axially until the limiting protrusions 322 and the limiting part 32 are located in the second inner cavity 111a. Then, the limiting part 32 is rotated so that the limiting protrusions 322 correspond to the intervals between the two limiting grooves 123, thereby achieving axial limiting of the limiting part 32.

[0071] Optionally, there are two limiting protrusions 322 and two limiting grooves 123, with the two limiting protrusions 322 spaced apart circumferentially and the two limiting grooves 123 spaced apart circumferentially.

[0072] Optionally, such as Figure 4 and Figure 6 As shown, the surface of the limiting protrusion 322 located in the accommodating space 11 and abutting the second abutting surface 122 can be bonded with an adhesive. A gap may be provided between the radial outer peripheral surface of the limiting protrusion 322 and the second inner cavity 111a, and the gap can be filled and bonded with an adhesive.

[0073] Optionally, the two ends of the limiting protrusion 322 in the circumferential direction can be increased with micro-protrusion structures by dispensing or welding, thereby limiting the circumferential rotational freedom of the limiting protrusion 322, so that the end 1 separates from the limiting part 3 during the operation of the house operator.

[0074] like Figure 3 and Figure 5 As shown, in some embodiments, the end 1 is provided with a positioning ring block 14, which is located at the distal end of the accommodating cavity 111. The positioning ring block 14 is fixed to the inner peripheral wall of the end 1, such that the accommodating cavity 111 includes a first inner cavity 141 and a second inner cavity 111a that are interconnected from the distal end to the proximal end. The first inner cavity 141 is the inner cavity of the positioning ring block 14. Along the radial direction of the end 1, the radial dimension of the first inner cavity 141 is smaller than the radial dimension of the second inner cavity 111a, such that a first abutting surface 13, a second abutting surface 122 and a third abutting surface 142 are formed in the end 1. The first abutting surface 13 is located at the distal end of the first inner cavity 141, and the third abutting surface 142 is the proximal end face of the positioning ring block 14. The pressure sensing element 2 is located at least in the first inner cavity 141, and the limiting part 32 is located in the second inner cavity 111a.

[0075] In some embodiments, the radial dimension of the pressure sensor 2 is smaller than the radial dimension of the first inner cavity 141, such that a first gap 15 is provided between the outer peripheral surface of the pressure sensor 2 and the inner peripheral surface of the first inner cavity 141. The first gap 15 provides space for the pressure sensor 2 to deform under pressure, thereby reducing interference caused by the limiting part 32 to the deformation of the pressure sensor 2, which is beneficial to improving the accuracy of the detection results of the pressure sensor 2. At the same time, it provides buffer space for the contact between the end 1 and the tissue, reducing damage to the tissue.

[0076] The first gap 15 allows for radial deformation of the pressure sensor 2 and / or the end 1. In other words, the first gap 15 allows for slight deflection of the end 1, facilitating the operator's identification of radial or axial pressure while reducing damage to tissues caused by the end 1. For example, when the axial pressure on the end 1 increases, it may compress the pressure sensor 2, causing a certain deformation in the axial direction and increasing the radial dimension of the pressure sensor 2. In this case, the change in the radial dimension of the pressure sensor 2 can be contained within the first gap 15, reducing the risk of the pressure sensor 2 coming into contact with the sidewall of the accommodating space 11 due to changes in axial pressure, and thus detecting the radial pressure. This helps reduce the operator's misjudgment of axial or radial pressure and improves the accuracy of the operator's adjustment of the end 1 position.

[0077] In some embodiments, the first gap 15 is less than the preset deformation amount of the pressure at the end 1, so that when the radial pressure at the end 1 is large, the pressure sensing element 2 can detect the radial pressure.

[0078] In some embodiments, the first gap 15 is smaller than the axial dimension of the pressure sensor 2 or smaller than the safety deformation of the pressure sensor 2, thereby reducing or even avoiding damage to the pressure sensor 2 due to excessive contact pressure.

[0079] In some embodiments, the radial dimension of the limiting portion 32 is larger than the radial dimension of the pressure sensing element 2, and a second gap 16 is provided between the distal end face of the limiting portion 32 and the third abutment surface 142. This causes a portion of the pressure sensing element 2 facing proximal to protrude from the first inner cavity 141 and abut against the limiting portion 32. The space where the limiting portion 32 is located is the second inner ring 111a. Since the radial dimension of the limiting portion 32 is larger than the radial dimension of the pressure sensing element 2, that is, the radial dimension of the second inner cavity 111a is larger than the radial dimension of the first inner cavity 141, and the axial dimension of the second inner cavity 111a is larger than the axial dimension of the limiting portion 32, a second gap 16 is formed between the distal end face of the limiting portion 32 and the third abutment surface 142. The second gap 16 provides space for the pressure sensing element 2 to deform under pressure, reducing interference from the limiting portion 32 on the deformation of the pressure sensing element 2, which helps improve the accuracy of the detection results of the pressure sensing element 2. Simultaneously, it provides buffer space for the contact between the end 1 and the tissue, reducing damage to the tissue.

[0080] Optionally, the second gap 16 is greater than the axial deformation size of the pressure sensing element 2, thereby reserving deformation space when the end 1 comes into contact with the tissue, which helps to improve the flexibility of the end 1 and reduce the damage of the end 1 to the tissue.

[0081] For example, the distal end of end 1 can be a hemispherical structure or an olive-shaped structure.

[0082] The radial dimension of the limiting part 32 is smaller than the radial dimension of the second inner cavity 111a, so that a third gap 17 is provided between the outer peripheral surface of the limiting part 32 and the inner peripheral surface of the second inner cavity 111a. This provides deformation space when the end 1 comes into contact with the tissue, which helps to improve the flexibility of the end 1 and reduce the damage of the end 1 to the tissue.

[0083] In some embodiments, both the end 1 and the ablation electrode 303 are electrically connected to wires, and both the pressure sensing element 2 and the limiting element 3 are provided with through holes extending in the axial direction. The through holes are wire passage holes for threading wires during the ablation procedure.

[0084] like Figure 2 and Figure 3 As shown, optionally, the pressure sensor 2 and the limiting part 32 fill the accommodating space 11, which helps to improve the sensitivity of the pressure sensor 2 to changes in the contact force between the end 1 and the tissue.

[0085] The ablation assembly 30 includes a sleeve 304, with the distal ends of multiple branch tubes 231 fixed to the sleeve 304; a limiting member 3 is inserted into the sleeve 304 to fix the head electrode assembly 10 to the distal end of the ablation assembly 20, which helps to improve the stability of the branch tubes 301.

[0086] like Figure 3 As shown, the sleeve 4 is fitted onto the limiting member 3 and abuts against the end face of the near end of the end 1.

[0087] In one embodiment, the proximal end of the limiting member 3 protrudes from the accommodating space 11 and is inserted into the head 304; the ablation catheter also includes a buffer pad 40, which is sleeved on the limiting member 3, located outside the accommodating space 11, and disposed on the distal end face of the head, with the distal end face of the buffer pad 40 abutting against the limiting member 3 and the end 1 along the axial direction; when the end 1 abuts against the tissue, the buffer pad 5 can absorb part of the axial displacement caused by the contact force of the end 1, and use the axial displacement to compress the pressure sensing element 2 inside the end 1, causing a change in pressure buffer parameters. This structure is beneficial for improving the flexibility of the head electrode assembly 10 and transmitting a portion of the force value to the pressure sensing element 2, thereby improving the force value output accuracy of the pressure sensing element 2.

[0088] In one embodiment, at least the distal end of the sleeve 304 and the distal ends of the plurality of branch pipes 301 are located within the accommodating space 11, so that the sleeve 4 and the end 1 together fix and limit the branch pipes 301, which is beneficial to further improve the stability of the branch pipes 301.

[0089] like Figure 1 , Figure 7 and Figures 9-10 In some embodiments, at least one branch tube 301 is further provided with an ablation electrode 303. The ablation electrode 303 is located near the middle of the branch tube 301, which is beneficial for the diameter of the position corresponding to the ablation electrode 303 to gradually increase during the switching process of the branch tube 301 from a straight shape to a cage shape and / or a petal shape. When the branch tube 301 is cage-shaped or petal-shaped, the ablation electrode 303 is located at the position of the largest diameter of the branch tube 301, which is beneficial for making full use of the radial dimension of the branch tube 301 and for maximizing the ablation range of the branch tube 301 in the cage-shaped and / or petal-shaped state.

[0090] In some embodiments, such as Figure 1 and Figures 7-10 When the branch tube 301 of the ablation catheter 100 is petal-shaped, it can be used to ablate the posterior wall of the left atrium. In this case, the branch tube 301 of the ablation catheter 100 performs two rows of ablation on the posterior wall of the atrium in a petal shape. The atrium (e.g., the left atrium) includes the top regions of the bilateral superior pulmonary veins and the bottom regions of the bilateral inferior pulmonary veins. When the branch tube 301 is adjusted to a petal shape, because the distal tip electrode assembly 10 of the ablation catheter 100 is higher than the plane of the ablation electrode 303 on the petal-shaped branch tube 301 (i.e., the distal surface of the tip electrode assembly 10 is farther from the distal surface of the main tube 202 than the distal surface of the branch tube 301, or the distance between the distal surface of the tip electrode assembly 10 and the distal surface of the main tube 202 is greater than the distance between the distal surface of the branch tube 301 and the distal surface of the main tube 202), the distal end of the control rod can be retracted into the main tube, or the branch tube can be pre-treated. The shape is fixed so that the distal surface of the petal-shaped support component protrudes beyond the distal surface of the head electrode assembly 10. Alternatively, a push sheath (not shown in the figure) is provided over the main tube, and the distal end of the push sheath is controlled to move towards the head electrode assembly until the push sheath wraps the support component in the petal shape, such as wrapping the proximal and distal ends of the branch tube in the petal shape, so that the middle part of the branch tube moves away from the distal end of the main tube until the distal surface of the support component protrudes beyond the distal surface of the head electrode assembly 10, thereby facilitating contact with the target tissue (such as atrial tissue).

[0091] In some embodiments, an ablation assembly includes a plurality of ablation electrodes 303, which are spaced apart along the axial direction of a branch tube 301, with at least one ablation electrode 303 positioned near the center of the branch tube 301. The simultaneous or time-sharing discharge of the multiple ablation electrodes 303 facilitates the formation of a larger, more uniform energy field, enabling the single-pass coverage of a larger lesion or tissue area, reducing the number of punctures and manipulations, and shortening the operation time. Exemplarily, the ablation catheter 100 is suitable for scenarios requiring large-area or multi-point ablation, such as complex cardiac arrhythmias.

[0092] The number of ablation electrodes 303 on each branch tube 301 can be any suitable number. For example, in this embodiment, each branch tube 301 is provided with two ablation electrodes 303.

[0093] In some embodiments, at least one probe 50 is provided on at least one tube 301. The probe 50 is used to map the potential difference of the target tissue before and after the release of ablation energy. The probe 50 is used to collect electrical signals, which helps the operator determine whether effective tissue ablation has been performed and whether tissue ablation has been completed, thereby improving the safety and efficiency of ablation of the posterior atrial wall using the ablation catheter 100 to some extent. The probe 50 is located at the distal end of the ablation electrode 303, which helps to reduce the impact of the energy during the operation of the ablation electrode 303 on the electrical signal acquisition of the probe 50, and helps to improve the accuracy of signal acquisition. At the same time, the distal location of the probe 50 allows it to preferentially contact the tissue to be ablated in order to locate the ablation position and improve the accuracy of the ablation area of ​​the ablation electrode 303. The probe 50 can display a three-dimensional model of the tissue to be ablated at the operator's operating end, which helps the operator determine the ablation position.

[0094] In some embodiments, there are multiple mapping electrodes 50, which are spaced apart along the axial direction of the branch tube 301. Having multiple mapping electrodes 50 on each branch tube 301 to simultaneously acquire electrical signals is beneficial for acquiring spatial location information and electrophysiological signals in cavities such as the heart and blood vessels, improving mapping accuracy and reducing the possibility of errors. The number of mapping electrodes 50 on each branch tube 301 can be any suitable number. For example, each branch tube 301 may have two mapping electrodes 50.

[0095] Optionally, the length of the mapping electrode 50 is shorter than the length of the ablation electrode 303. A shorter mapping electrode 50 allows for more precise positioning of the ablation electrode 303 at the acquisition location, enabling real-time monitoring of the ablation results. It also helps reduce interference from the ablation energy on the signal acquisition of the mapping electrode 50, improving the accuracy of the mapping location. A longer ablation electrode 303 increases the area of ​​energy application, improves the stability of energy conduction, and expands the lesion coverage area.

[0096] For example, the length of the calibration electrode 50 along the axial direction is 0.5 mm to 0.8 mm to achieve accurate electrical signal acquisition.

[0097] Optionally, the ablation catheter 100 also includes a bending adjustment component (not shown in the figure), which is located at the distal end of the main tube 202 to allow the operator to adjust the axial angle between the control tube 201 and the blood vessel to be ablated, thereby improving the coaxiality between the axis of the control tube 201 and the blood vessel to be ablated.

[0098] In some embodiments, the ablation catheter further includes a coaxial detection component 60, which is disposed in the control tube 201 and located within the enclosing space 302. The coaxial detection component 60 is configured to detect the coaxiality of the axis of the control tube 201 with the axis of the vessel to be ablated. The ablation catheter 100 can confirm the coaxiality of the ablation area (such as the ablation component) of the ablation catheter 100 with the vessel to be ablated (such as the left superior pulmonary vein (LSPV)) through the coaxial detection component 60. This allows the operator to adjust the bending component according to the detection results to adjust the axis angle of the control tube 201 so that the ablation area and the vessel to be ablated remain coaxial. Compared with the problem of local contact being too tight or too loose in the non-coaxial state, the coaxial state is conducive to improving the stability of effective transmission of ablation energy, and also helps to reduce problems such as incomplete ablation or repeated operations caused by poor contact, and helps to reduce the risk of tissue damage caused by excessive local pressure. Meanwhile, adjusting the ablation area to be coaxial with the blood vessel to be ablated by the detection results of the coaxial detection component 60 helps reduce the risk of blood vessel wall scratches caused by guidewire assistance, reduces the number of guidewire insertion, adjustment and withdrawal operations, reduces the number of intervention steps of surgical instruments in the body, and shortens the operation time, thereby improving ablation safety and surgical efficiency.

[0099] In some embodiments, the coaxial detection assembly 60 includes a magnetic positioning element 601 and / or a reference electrode element 602. The magnetic positioning element 601 is configured to detect the coaxiality of the axis of the control tube 201 with the axis of the blood vessel to be ablated by an electromagnetic field; the reference electrode element 602 is configured to detect the coaxiality of the axis of the control tube 201 with the axis of the blood vessel to be ablated by a current field.

[0100] In some embodiments, the coaxial detection assembly 60 includes a magnetic positioning element 601, configured to detect the coaxiality of the axis of the control tube 201 with the axis of the blood vessel to be ablated via an electromagnetic field. The magnetic positioning element 601 can detect the axial position of the ablation catheter 100. Based on the three-dimensional model of the tissue detected by the mapping electrode 50, the operator can obtain the tissue contour of the blood vessel to be ablated. Combining this with the axial position of the control tube 201 detected by the magnetic positioning element 601, the operator can determine whether the two are coaxial based on the position of the axis of the control tube 201 relative to the axis of the tissue. When the operator determines that the two are not coaxial based on the detection results, the axial direction of the control tube 201 can be adjusted to keep the control tube 201 coaxial with the tissue.

[0101] In some embodiments, the magnetic positioning element 601 includes a first magnetic positioning sensor (not shown) and a second magnetic positioning sensor (not shown). The first magnetic positioning sensor is located at the distal end of the main tube 202; the second magnetic positioning sensor is located on the control tube 201 and is positioned close to the head electrode assembly 10. The first and second magnetic positioning sensors jointly detect both ends of the control tube 201 to determine the axial position and angle of the control tube 201, which helps to improve the accuracy of the detection results.

[0102] In some embodiments, the coaxial detection assembly 60 includes a reference electrode 602 configured to detect the coaxiality of the axis of the control tube 201 with the axis of the blood vessel to be ablated via a current field. Based on the detected axial position of the control tube 201, the reference electrode 602 allows the operator to determine whether the control tube 201 is coaxial with the tissue and adjust the axial angle of the control tube 201 according to the detection result to maintain coaxiality between the control tube 201 and the tissue.

[0103] In some embodiments, the coaxial detection assembly 60 includes both a magnetic positioning element 601 and a reference electrode element 602. The detection results of the reference electrode element 602 and the magnetic positioning element 601 can be mutually corrected to improve the accuracy of positioning and modeling information. This helps to reduce the possibility that some ablation electrodes 303 may not be in contact with the tissue or may not be in good contact during ablation in a non-coaxial state. It also helps to reduce the phenomenon of empty discharge of ablation electrodes 303 in the blood pool and helps to reduce the risk of hemolysis in patients.

[0104] In some embodiments, the reference electrode 602 includes a first reference electrode pair (not shown) and a second reference electrode pair (not shown). The first reference electrode pair is disposed at the distal end of the main tube 202, and the second reference electrode pair is disposed on the control tube 201, and is located close to the head electrode assembly 10. This arrangement of the reference electrode 602 facilitates the proximity of the first and second reference electrode pairs to the first and second magnetic positioning sensors, respectively, thereby improving the supplementary effect of the reference electrode 602 on the positioning of the magnetic positioning element 601 and ultimately enhancing the accuracy of the detection results.

[0105] In some embodiments, the first reference electrode pair consists of two annular reference electrodes arranged axially on both sides of the first magnetic positioning sensor, and the second reference electrode pair consists of two annular reference electrodes arranged axially on both sides of the second magnetic positioning sensor.

[0106] In some embodiments, such as Figure 7 As shown, Figure 7 This diagram illustrates ablation of the posterior atrial wall. In this case, the branch tube 301 is petal-shaped, and the ablation electrode 303 and the head electrode assembly 10 are attached to the posterior atrial wall tissue. During ablation of the posterior atrial wall, the ablation lines can be used as the lines connecting the left superior pulmonary vein (LSPV) to the right superior pulmonary vein (RSPV) and the left inferior pulmonary vein (LIPV) to the right inferior pulmonary vein (RIPV).

[0107] In some embodiments, such as Figure 8 As shown, Figure 8 This is a schematic diagram of the ablation catheter 100 performing ablation on the pulmonary vein orifice and vestibule. Under fluoroscopic guidance, the operator can insert the distal end of the ablation catheter 100 (e.g., support component 202) into the corresponding pulmonary vein. The magnetic positioning component 601 and reference electrode component 602 jointly position the axis of the head electrode assembly 10 and control tube 201 of the ablation catheter 100. This determines the relative position and angle between the axes of the multiple ablation electrodes 303 and the axis of the tissue when the branch tube 301 is linear, cage-shaped, or petal-shaped. The operator then determines whether the ablation area is coaxial with the pulmonary vein and adjusts the bending component accordingly to ensure coaxiality between the ablation area (e.g., branch tube 301) and the pulmonary vein.

[0108] In some embodiments, the head electrode assembly 10 may be omitted. Figure 9 This is a schematic diagram of the discharge mode of the ablation electrode 303 when the electrode assembly 10 is not attached. Figure 9 This is a schematic diagram of the ablation catheter 100 performing ablation on the pulmonary vein orifice and vestibule. The principle is similar to that described in the previous paragraph and will not be repeated here.

[0109] In some embodiments, Figure 10This is a schematic diagram of an ablation electrode 303 on an ablation catheter 100 with a head electrode assembly 10 performing ablation on a pulmonary vein. At this time, the head electrode assembly 10 is not in contact with the tissue. The ablation electrode 303 on the branch 301 can switch between negative and positive polarities. In two circumferentially adjacent branch 301 ablation electrodes 303, one branch 301 has a positive electrode and the other branch 301 has a negative electrode to form a paired electric field, thereby performing the treatment procedure on the target tissue.

[0110] It should be noted that the technical solutions formed by any of the above-described implementation methods (or embodiments) or any combination of implementation methods (or embodiments) are all within the scope of protection of this application.

[0111] Whenever a range of values ​​is indicated in this application, it refers to any of the listed values ​​(fractions and integers) that fall within the indicated range. The phrases “range between the first indicated value and the second indicated value” and “range from the first indicated value to the second indicated value” are used interchangeably in this application and refer to the first and second indicated values ​​as well as all fractional and integer values ​​in between.

[0112] As used herein, when used in conjunction with numerical values ​​and / or ranges, the terms “about” and / or “approximately” generally refer to those numerical values ​​and / or ranges that are close to the stated numerical value and / or range. In some cases, the terms “about” and “approximately” may mean within ±10% of the stated value. For example, in some cases, “about 100 [units]” may mean within ±10% of 100 (e.g., 90 to 110). The terms “about” and “approximately” may be used interchangeably.

[0113] As used in this application, the singular forms “an,” “a,” and “” include the plural forms unless the context clearly specifies otherwise. For example, the terms “a compound” or “at least one compound” can include a variety of compounds, including mixtures thereof.

[0114] The term "basically composed of" means that the composition, method, or structure may include additional ingredients, steps, and / or components, provided that these additional ingredients, steps, and / or components do not significantly alter the fundamental and novel properties of the claimed composition, method, or structure.

[0115] The implementation of the methods and / or systems of this application may include performing or fully performing selected tasks manually, automatically, or in a combination thereof. Furthermore, the actual instruments and equipment used in the implementation of the methods and / or systems of this application, using an operating system, may implement several selected tasks via hardware, software, firmware, or a combination thereof.

[0116] For example, the hardware used to perform the selected task according to embodiments of this application can be implemented in the form of a chip or circuit. As software, the selected task according to embodiments of this application can be implemented in the form of multiple software instructions executable by a computer using any suitable operating system. In exemplary embodiments of this application, one or more tasks of exemplary embodiments of the methods and / or systems according to this application are performed by a data processor, such as a computing platform for executing multiple instructions. Optionally, the data processor includes volatile memory for storing instructions and / or data and / or non-volatile memory for storing instructions and / or data, such as a magnetic hard disk and / or removable media. Optionally, a network connection is also provided. A display and / or user input devices such as a keyboard or mouse are also optionally provided.

[0117] It should be understood that certain features of this application described in the context of a single implementation for clarity can also be provided in combination in a single implementation. Conversely, multiple features of this application described in the context of a single implementation for brevity can also be provided individually or in any suitable sub-combination or, as appropriate, in any other described implementation of this application. Certain features described in the context of multiple implementations should not be considered essential features of those implementations unless the implementation does not function without these elements.

[0118] Although this application has been described in conjunction with its specific embodiments, it will be apparent to those skilled in the art that many alternatives, modifications, and variations are possible. Therefore, it is intended to include all such alternatives, modifications, and variations falling within the spirit and broad scope of the appended claims.

Claims

1. A head electrode assembly, characterized in that, The head electrode assembly, located at the distal end of the ablation catheter, includes: An end (1) having a receiving space (11) therein, the receiving space (11) extending axially to the proximal end face of the end (1), the end (1) being used to release ablation energy; and A pressure sensor (2) is located in the accommodating space (11), and the pressure sensor (2) abuts against the end (1) at least axially to detect the external pressure on the end (1); The pressure sensor (2) is configured to sense at least one of the axial pressure and radial pressure on the end (1); A limiting member (3) is provided on the end (1), and the limiting member (3) and the end (1) are configured to at least jointly limit the axial displacement of the pressure sensing element (2).

2. The head electrode assembly according to claim 1, characterized in that, The distal end face of the pressure sensor (2) abuts against the end (1) in the axial direction. The limiting member (3) is located at the proximal end of the pressure sensor (2). The limiting member (3) and the end (1) are configured to jointly limit the axial displacement of the pressure sensor (2).

3. The head electrode assembly according to claim 2, characterized in that, The end (1) is provided with a limiting ring block (12), the limiting ring block (12) is located at the proximal end of the accommodating space (11), the limiting ring block (12) is fixed to the inner peripheral wall of the end (1), so that the accommodating space (11) includes an accommodating cavity (111) and a limiting channel (121) that are interconnected from the distal end to the proximal end, and the limiting channel (121) is the inner cavity of the limiting ring block (12); Along the radial direction of the end (1), the radial dimension of the accommodating cavity (111) is greater than the radial dimension of the limiting channel (121), such that a first abutting surface (13) and a second abutting surface (122) are formed in the end (1). The first abutting surface (13) is the distal inner wall surface of the end (1) and is located at the distal end of the accommodating cavity (111). The second abutting surface (122) is the distal end surface of the limiting ring block (12). The pressure sensing element (2) is located in the accommodating cavity (111), and the first abutting surface (13) abuts against the distal end surface of the pressure sensing element (2). The limiting element (3) is disposed on the limiting ring block (12).

4. The head electrode assembly according to claim 3, characterized in that, The limiting member (3) includes: The connecting part (31) passes through the limiting channel (121); and The limiting part (32) is connected to the distal end of the connecting part (31) and the limiting part (32) is located in the accommodating cavity (111). The distal end face of the limiting part (32) abuts against the pressure sensing element (2) and the proximal end face of the limiting part (32) abuts against the second abutting surface (122).

5. The head electrode assembly according to claim 4, characterized in that, The limiting ring block (12) is provided with at least one limiting groove (123), the limiting groove (123) penetrates the inner peripheral wall of the limiting ring block (12) radially, and the limiting part (32) includes: a limiting body (321) and at least one limiting protrusion (322) disposed on the outer periphery of the limiting body (321). Each limiting protrusion (322) corresponds to one limiting groove (123). The radial dimension of the limiting body (321) is not greater than the radial dimension of the limiting channel (121), the radial dimension of the limiting protrusion (322) is greater than the radial dimension of the limiting channel (121), the radial dimension of the limiting protrusion (322) is the same as the radial dimension of the limiting groove (123), and the limiting part (32) abuts against the second abutting surface (122) through the limiting protrusion (322).

6. The head electrode assembly according to claim 5, characterized in that, The limiting protrusions (322) are provided in multiple ways, and the multiple limiting protrusions (322) are arranged at intervals along the circumference of the limiting body (321).

7. The head electrode assembly according to any one of claims 4-6, characterized in that, The end (1) is provided with a positioning ring block (14), the positioning ring block (14) is located at the distal end of the accommodating cavity (111), the positioning ring block (14) is fixed to the inner peripheral wall of the end (1), such that the accommodating cavity (111) includes a first inner cavity (141) and a second inner cavity (111a) that are interconnected from the distal end to the proximal end, the first inner cavity (141) is the inner cavity of the positioning ring block (14); Along the radial direction of the end (1), the radial dimension of the first inner cavity (141) is smaller than the radial dimension of the second inner cavity (111a), such that the first abutting surface (13), the second abutting surface (122) and the third abutting surface (142) are formed in the end (1). The first abutting surface (13) is located at the far end of the first inner cavity (141), and the third abutting surface (142) is the proximal end face of the positioning ring block (14). The pressure sensing element (2) is located at least in the first inner cavity (141), and the limiting part (32) is located in the second inner cavity (111a).

8. The head electrode assembly according to claim 7, characterized in that, The radial dimension of the pressure sensor (2) is smaller than the radial dimension of the first inner cavity (141), so that a first gap (15) is provided between the outer peripheral surface of the pressure sensor (2) and the inner peripheral surface of the first inner cavity (141).

9. The head electrode assembly according to claim 7, characterized in that, The radial dimension of the limiting part (32) is larger than the radial dimension of the pressure sensing element (2), and the distal end surface of the limiting part (32) and the third contact surface (142) are provided with a second gap (16).

10. The head electrode assembly according to claim 9, characterized in that, The second gap (16) is greater than the deformation dimension of the pressure sensing element (2) along the axial direction.

11. The head electrode assembly according to claim 9, characterized in that, The radial dimension of the limiting part (32) is smaller than the radial dimension of the second inner cavity (111a), so that a third gap (17) is provided between the outer peripheral surface of the limiting part (32) and the inner peripheral surface of the second inner cavity (111a).

12. An ablation catheter, characterized in that, include: The head electrode assembly (10) is the head electrode assembly according to any one of claims 1-11 above; The catheter assembly (20) includes a control tube (201) and a main tube (202), wherein the control tube (201) is inserted into the main tube (202), and the distal end of the control tube (201) is located on the distal side of the main tube (202); The ablation component (30) is located at the distal end of the main tube (202), the proximal end of the ablation component (30) is connected to the main tube (202), and the distal end of the ablation component (30) is connected to the distal end of the control tube (201). The ablation component (30) has an extended form and a contracted form, and the radial dimension of the extended form is greater than the radial dimension of the contracted form. The head electrode assembly (10) is located at the distal end of the ablation assembly (20); The ablation component (20) includes a plurality of branch tubes (301), which are distributed at intervals along the circumference of the ablation component (20) to enclose a space (302). At least one branch tube (301) is provided with at least one ablation electrode (303), and the head electrode assembly (10) is located at the distal end of the ablation component (30). One of the control tube (201) and the main tube (202) is axially movable relative to the other, so that the ablation assembly (30) can switch between the expanded and contracted states.

13. The ablation catheter according to claim 12, characterized in that, The ablation assembly (30) includes a sleeve (304), the distal ends of the plurality of branch tubes (231) are fixed to the sleeve (304); the limiting member (3) is inserted into the sleeve (304) to fix the head electrode assembly (10) to the distal end of the ablation assembly (20).

14. The ablation catheter according to claim 13, characterized in that, Includes either i) or ii) below: i) The proximal end of the limiting member (3) protrudes from the accommodating space (11) and is inserted into the sleeve (304); the ablation catheter also includes a buffer pad (40), the buffer pad (40) is sleeved on the limiting member (3), the buffer pad (40) is located outside the accommodating space (11), the buffer pad (40) is located on the distal end face of the sleeve, and the distal end face of the buffer pad (40) along the axial direction abuts against the limiting member (3) and the end (1); ii) At least the distal end of the head (304) and the distal ends of the plurality of branches (301) are located within the accommodating space (11).

15. The ablation catheter according to claim 12, characterized in that, At least one of the branch tubes (301) is further provided with at least one calibration electrode (50), which is used to measure the potential difference of the target tissue before and after the ablation energy is released.

16. The ablation catheter according to claim 13, characterized in that, The ablation catheter also includes: A coaxial detection component (60), disposed in the control tube (201) and located within the enclosed space (302), is configured to detect the coaxiality of the axis of the control tube (201) and the axis of the blood vessel to be ablated; the coaxial detection component (60) includes: The magnetic positioning element (601) is configured to detect the coaxiality of the axis of the control tube (201) with the axis of the blood vessel to be ablated via an electromagnetic field; and And / or, the reference electrode (602) is configured to detect the coaxiality of the axis of the control tube (201) with the axis of the blood vessel to be ablated by means of a current field.

17. The ablation catheter according to claim 16, characterized in that, The magnetic positioning element (601) includes: A first magnetic positioning sensor is disposed at the distal end of the main tube (202); and A second magnetic positioning sensor is disposed on the control tube (201) and is disposed close to the head electrode assembly (10).

18. The ablation catheter according to claim 16, characterized in that, The reference electrode (602) includes: A first reference electrode pair is disposed at the distal end of the main tube (202); and The second reference electrode pair is disposed on the control tube (201) and is disposed close to the head electrode assembly.

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