Electrophysiology catheter

Abstract

The present application relates to an electrophysiological catheter. The electrophysiological catheter includes a sleeved inner tube and an outer tube, with an annular accommodating channel between the inner tube and the outer tube, and an electrode assembly at least partially extending into the accommodating channel. The electrode assembly includes: a base body, the base body is deformable, and the two ends of the base body along the length direction are respectively connected to the inner tube and the outer tube. The base body includes at least a plurality of first base bodies and a plurality of second base bodies. In the cross section of the electrophysiological catheter, the plurality of first base bodies are arranged circumferentially around the accommodating channel with a first diameter, and the plurality of second base bodies are arranged circumferentially around the accommodating channel with a second diameter, the second diameter is smaller than the first diameter, and in the radial direction, the second base body is at least partially located between two adjacent first base bodies; at least one electrode is connected to the base body, and the plurality of electrodes are arranged along the length direction of the base body. The solution provided by the present application can add more electrodes without increasing the size of the catheter, thereby improving the efficiency of use.

Description

Technical Field

[0001] The present application relates to the field of medical device technology, and in particular to an electrophysiological catheter. Background Art

[0002] With the continuous increase in the number of patients in the heart rate market, the continuous development of medical technology, the advancement of minimally invasive interventional devices and other factors, the field of electrophysiology has gradually received more attention. The instruments related to cardiac electrophysiological interventional technology mainly include mapping catheters, ablation catheters and other electrophysiological interventional devices. Among them, mapping catheters and most ablation catheters (radiofrequency ablation and pulsed field ablation) are collectively referred to as electrophysiological catheters. The catheters require metal electrodes as a medium for signal or energy transmission, and the shape and density of the electrodes have a great influence on the efficiency and effect of mapping catheters and ablation catheters (radiofrequency ablation and pulsed field ablation). In electrophysiological catheters, the electrodes are generally limited by the size of the catheter. How to set more electrodes in a limited space has become a key point and a difficulty. Summary of the Invention

[0003] In order to solve or partially solve the problems existing in the related art, the present application provides an electrophysiological catheter that can add more electrodes without increasing the size of the catheter, thereby improving its efficiency.

[0004] The present application provides an electrophysiological catheter, comprising an inner tube and an outer tube connected together, an annular accommodating channel being defined between the inner tube and the outer tube, an electrode assembly at least partially extending into the accommodating channel, and the electrode assembly comprising:

[0005] a plurality of bases, each of which is deformable and connected to the inner tube and the outer tube at both ends along the length direction, the bases comprising at least a first base and a second base. In a cross section of the electrophysiological catheter, the bases are located in the accommodating channel. A plurality of the first bases are arranged circumferentially around the accommodating channel with a first diameter. A plurality of the second bases are arranged circumferentially around the accommodating channel with a second diameter, the second diameter being smaller than the first diameter. In a radial direction, the second bases are at least partially located between two adjacent first bases.

[0006] At least one electrode is connected to the substrate, and a plurality of electrodes are arranged along the length direction of the substrate.

[0007] In one embodiment, along the mating direction of the inner tube and the outer tube, the first substrate is located on the outer layer of the second substrate.

[0008] A plurality of the first bases and a plurality of the second bases are respectively arranged at intervals around the circumference of the accommodating channel, and a gap between adjacent first bases is larger than a gap between adjacent second bases.

[0009] In one embodiment, along the length direction of the substrate, the sum of the areas of the cross sections of the substrate is a preset area, and the cross section of the substrate includes at least one of an ellipse and a polygon.

[0010] In one embodiment, the ratio of the sum of the cross-sectional areas of the substrates to the cross-sectional area of ​​the accommodating channel is greater than sixty-five percent.

[0011] In one embodiment, the base further includes a third base, which is located in the inner layer of the second base along the fitting direction of the inner tube and the outer tube. A plurality of the third bases are arranged around the accommodating channel at a third diameter, and the gap between adjacent second bases is larger than the gap between adjacent third bases.

[0012] In one embodiment, the matrix comprises at least a first state and a second state.

[0013] In the first state, the length direction of the base is parallel to the axial direction of the electrophysiological catheter, and at least a portion of the base extends into the accommodating channel;

[0014] In the second state, the two ends of the substrate in the length direction are close to each other, and the substrate can be deformed, so that multiple first substrates and multiple second substrates form a preset first shape and a preset second shape respectively, and the planes formed by the maximum diameters of the preset first shape and the preset second shape are located in the same plane, and the electrode is at least arranged at the position corresponding to the maximum diameter of the substrate.

[0015] In one embodiment, in the second state, the deformation degree of the second substrate is greater than the deformation degree of the first substrate, so that the maximum diameter of the preset second shape formed is the same as the maximum diameter of the preset first shape formed, and the first substrate and the second substrate are arranged in an staggered manner.

[0016] In one embodiment, a connecting component is provided at one end of the inner tube extending from the outer tube, and the connecting component includes a first connecting portion and a second connecting portion arranged in sequence along the axial direction, the first connecting portion is located on a side of the second connecting portion away from the outer tube, and a preset distance is provided between the first connecting portion and the second connecting portion.

[0017] An end portion of the first base is fixedly connected to the first connecting portion, and an end portion of the second base is fixedly connected to the second connecting portion.

[0018] In one embodiment, as the preset distance increases, the deformation degree of the second substrate increases.

[0019] In one embodiment, the electrophysiological catheter further includes an adjusting portion, which connects the inner tube and the outer tube and is used to drive the inner tube to move relative to the outer tube in an axial direction, so that the base is switched between the first state and the second state.

[0020] The technical solution provided by the present application may have the following beneficial effects: the electrode assembly includes multiple deformable substrates, each of which is connected to an inner tube and an outer tube at both ends along its length, and includes at least a first substrate and a second substrate. In the cross section of the electrophysiology catheter, the substrate is located in the receiving channel, multiple first substrates are arranged circumferentially around the receiving channel with a first diameter, and multiple second substrates are arranged circumferentially around the receiving channel with a second diameter that is smaller than the first diameter. In the radial direction, the second substrate is at least partially located between two adjacent first substrates; at least one electrode is connected to the substrate, and the multiple electrodes are arranged along the length of the substrate. This at least two-layer arrangement can be confined to the spatial range of the receiving channel when inserted into a blood vessel without exceeding the maximum diameter of the catheter. After insertion into the heart, the multi-layer substrate arrangement effectively increases the number of electrodes, and the density between the electrodes is also increased after the electrode assembly is unfolded, effectively improving the efficiency and effectiveness of treatment and shortening the operation time.

[0021] It should be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The above and other objects, features and advantages of the present application will become more apparent through a more detailed description of exemplary embodiments of the present application in conjunction with the accompanying drawings, wherein the same reference numerals generally represent the same components in the exemplary embodiments of the present application.

[0023] Figure 1 1 is a schematic diagram of the structure of the electrode assembly at the head position of the electrophysiological catheter shown in an embodiment of the present application;

[0024] Figure 2 is a cross-sectional view of the electrode assembly and the catheter of the electrophysiological catheter shown in an embodiment of the present application;

[0025] Figure 3 Schematic diagram of the base structure of the electrophysiological catheter shown in an embodiment of the present application;

[0026] Figure 4 is a schematic diagram of the electrode structure of an electrophysiological catheter shown in an embodiment of the present application;

[0027] Figure 5 is a schematic structural diagram of the second state of the electrophysiological catheter shown in an embodiment of the present application;

[0028] Figure 6 yes Figure 5 A partial enlarged view of the middle electrode assembly;

[0029] Figure 7 is a schematic structural diagram of the first state of an electrophysiological catheter shown in an embodiment of the present application;

[0030] Figure 8 yes Figure 7 A partial enlarged view of part B. DETAILED DESCRIPTION

[0031] The following describes embodiments of the present application in more detail with reference to the accompanying drawings. Although the accompanying drawings illustrate embodiments of the present application, it should be understood that the present application can be implemented in various forms and should not be limited by the embodiments described 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.

[0032] The terms used in this application are for the purpose of describing specific embodiments only and are not intended to limit this application. As used in this application and the appended claims, the singular forms "a," "an," "the," and "the" are 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 encompasses any and all possible combinations of one or more of the associated listed items.

[0033] It should be understood that although the terms "first", "second", "third", etc. may be used in this application to describe various information, this information should not be limited to these terms. These terms are only used to distinguish information of the same type from each other. For example, without departing from the scope of this application, the first information may also be referred to as the second information, and similarly, the second information may also be referred to as the first information. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of this application, the meaning of "plurality" is two or more, unless otherwise clearly and specifically defined.

[0034] In surgeries utilizing electrophysiological therapy, it is common to use catheters to transmit energy and perform tissue ablation or mapping. This is achieved by using electrodes installed on the catheter as a medium for signal or energy transmission. For example, instruments related to cardiac electrophysiological interventional technology mainly include mapping catheters, ablation catheters, and other electrophysiological interventional devices, which we collectively refer to as electrophysiological catheters without making specific distinctions. Electrophysiological catheters are always equipped with metal electrodes as a medium for signal or energy transmission, and the shape and density of the electrodes have a significant impact on the efficiency and effectiveness of the electrophysiological catheter.

[0035] Generally, electrophysiology catheters need to pass through blood vessels into the heart, so there are certain restrictions on the catheter's diameter. The smaller the catheter diameter, the better the catheter's passability. The catheter's head needs to be equipped with electrodes to reach the target location for treatment or mapping. The catheter's tail is connected to a power source to provide radiofrequency or pulses to the electrodes, or to serve as a channel for transmitting intracardiac electrical signals collected by the electrodes to the device. To ensure that the electrodes can pass smoothly through the blood vessels and into the heart with the catheter, the multiple electrodes are retracted to the catheter wall and cannot exceed the maximum diameter of the catheter. After entering the heart, the multiple electrodes need to be deployed into an umbrella or basket shape to act on the relatively large space inside the heart. To achieve good treatment effects and efficient signal acquisition, after the electrodes are deployed inside the heart, the electrophysiology catheter needs to have the characteristics of a large ablation area, a uniform electric field, good adhesion, strong support, relatively stable electrode position, and simple operation. This requires a higher density and more stable shape of the electrodes inside the heart. However, given the limitation of the maximum diameter of the catheter, the number and density of the electrodes are also limited. Therefore, there is a conflict between reducing the diameter of the catheter and increasing the ablation effect, making it impossible for the electrophysiology catheter to meet both requirements at the same time.

[0036] In response to the above problems, an embodiment of the present application provides an electrophysiological catheter that can add more electrodes without increasing the size of the catheter, thereby improving its efficiency and effectiveness.

[0037] The technical solutions of the embodiments of the present application are described in detail below with reference to the accompanying drawings.

[0038] Figure 1 Schematic diagram of the electrode assembly structure at the head position of the electrophysiological catheter shown in an embodiment of the present application. Figure 2 This is a cross-sectional view of the electrode assembly of the electrophysiology catheter shown in an embodiment of the present application in cooperation with the catheter.

[0039] like Figure 1 and Figure 2As shown, as one embodiment of the present application, an electrophysiology catheter includes a sleeved inner tube 2 and an outer tube 1, with an annular accommodating channel 11 formed between the inner tube 2 and the outer tube 1, and an electrode assembly at least partially extending into the accommodating channel 11. At the end of the electrophysiology catheter, the annular accommodating channel 11 formed between the sleeved inner tube 2 and the outer tube 1 can be used to accommodate the electrode assembly. During relative movement between the inner tube 2 and the outer tube 1, when the inner tube 2 extends a certain distance from the outer tube 1, the electrode assembly is located within the diameter range of the accommodating channel 11 and is in contact with the outer wall of the inner tube 2. In this case, the maximum diameter of the electrode assembly does not exceed the diameter of the inner wall of the outer tube 1, which is beneficial for the catheter's passage performance when the electrophysiology catheter is inserted into a blood vessel. When the end reaches the heart, the distance the inner tube extends into the outer tube 1 can be controlled to decrease, thereby causing the electrode assembly connecting the inner tube 2 and the outer tube 1 to deform into a treatment state. In order to ensure the efficiency and effectiveness of treatment in this state, the electrode assembly is designed accordingly based on not exceeding the shaded range of the accommodating channel 11 in the axial direction.

[0040] The electrode assembly includes a base 3 and at least one electrode 4 connected to the base 3. Multiple electrodes 4 are arranged along the length of the base 3. The base 3 is deformable, and its ends along the length are connected to the inner tube 2 and the outer tube 1, respectively. The base 3 comprises at least a plurality of first bases 31 and a plurality of second bases 32. In the cross-section of the electrophysiology catheter, the base 3 is positioned within the receiving channel 11. The first bases 31 are arranged circumferentially around the receiving channel 11 with a first diameter L1. The second bases 32 are arranged circumferentially around the receiving channel 11 with a second diameter L2 that is smaller than the first diameter L1. In the radial direction, the second bases 32 are at least partially located between adjacent first bases 31. Along the catheter's axial direction, the electrode assembly maximizes the utilization of the limited shadow area enclosed by the receiving channel 11 by arranging the bases 3 into at least two layers of annular structures arranged within the receiving channel 11. This arrangement of at least two layers allows the catheter to be confined within the spatial range of the accommodating channel 11 when inserted into the blood vessel without exceeding the maximum diameter of the catheter. After being inserted into the heart, the arrangement structure of the multi-layer substrate 3 effectively increases the number of electrodes, and the density between the electrodes is increased after the electrode assembly is unfolded, thereby effectively improving the efficiency and effect of the treatment and shortening the operation time.

[0041] In one embodiment, the base 3 has at least a first state and a second state. In the first state, the length direction of the base 3 is parallel to the axis of the electrophysiology catheter, and at least a portion of the base 3 extends into the accommodating channel 11. In this first state (the tightened state), the base 3 is arranged in at least a double-layered annular configuration within the accommodating channel 11. For example, in a double-layered configuration, the second base 32 located in the layer closest to the inner tube 2 can at least partially adhere to the outer surface of the inner tube 2 along the circumference of the inner tube 2, and the first base 31 located in the layer closest to the outer tube 1 can at least partially adhere to the inner wall of the outer tube 1 along the circumference of the inner tube 2. The two layers of first and second bases 31, 32 are arranged circumferentially around the accommodating channel 11 with different diameters, and the first and second bases 31, 32 are staggered in the radial direction. This improves the utilization of the area enclosed by the accommodating channel 11, allowing for the arrangement of more bases 3 within the limited area, thereby facilitating a higher density of electrodes 4 disposed on the base 3 during ablation. That is, in the second state (the deployed state), as the distance that the inner tube 2 extends from the outer tube 1 decreases, the two ends of the matrix 3 in the longitudinal direction approach each other, and the matrix 3 is deformable, so that the multiple first matrices 31 and the multiple second matrices 32 respectively form a predetermined first shape and a predetermined second shape. After forming the predetermined first shape and the predetermined second shape, the electrodes 4 located in the first matrices 31 and the second matrices 32 are arranged at intervals in the deployed state, and the distance between the multiple electrodes 4 is relatively small. When the electrodes 4 act on the treatment location, the simultaneous action of the multiple electrodes 4 and the closer or intersecting fields generated by adjacent electrode pairs can increase the intensity of the electrodes 4, thereby improving the efficiency of the treatment.

[0042] In the mating direction of the inner tube 2 and the outer tube 1, the first substrate 31 is located on the outer layer of the second substrate 32. Multiple first substrates 31 and multiple second substrates 32 are spaced apart circumferentially around the accommodating channel 11, with the gaps between adjacent first substrates 31 being larger than the gaps between adjacent second substrates 32. Optionally, the multiple first substrates 31 and multiple second substrates 32 are evenly arranged within each layer. This gap-free and even arrangement creates a structural coordination of different layers. After transitioning from the first state to the second state, the electrodes 4 within each layer can be evenly arranged circumferentially to form a corresponding predetermined shape. At the same time, the arrangement of the second substrate 32 radially between the two first substrates 31 increases the types of second preset shapes that can be allowed in the second state. For example, the second preset shape can be located inside the shape enclosed by the first preset shape, or part of the second preset shape can extend from the gap between the two first substrates 31, so that part of the second preset shape is within the range enclosed by the first preset shape, and the other part is outside the range, or the maximum deformation position of the second preset shape coincides with part of the first preset shape, so that the electrodes 4 set on the first substrate 31 and the second substrate 32 are evenly arranged on the same ring, thereby increasing the density of the electrode 4 and the ablation efficiency, and preventing the first substrate 31 and the second substrate 32 from partially contacting each other, causing the electrodes 4 set thereon to be in contact and connected, thereby destroying the treatment effect.

[0043] It is understood that before the electrode assembly is installed in the electrophysiology catheter, it needs to be pre-shaped to form the corresponding preset shapes in different layers. That is, each layer of the multiple substrates 3 formed in the accommodating channel 11 is pre-shaped according to the shape required in the second state. This avoids the multi-layer substrate 3 having a large unpredictability when transitioning from the first state to the second state, resulting in large differences in the shape formed by each layer, and thus large differences in the gaps between the electrodes 4 in different layers, resulting in uneven electrode distribution density, which in turn affects the use effect.

[0044] As for the preset first shape and the preset second shape, in order to match the treatment position in the human body, they are generally circular depressions or cavity structures. Therefore, in order to ensure the uniformity and stability of the simultaneous treatment of the surrounding tissues, the preset first shape and the preset second shape are spherical structures formed by multiple bases 3 spaced apart and evenly arranged.

[0045] Optionally, for the predetermined first and second shapes, to ensure that the electrodes 4 can uniformly act on the treatment location in the circumferential direction and with high efficiency in the second state, the plane formed by the maximum diameters of the predetermined first and second shapes can be located on the same plane A, and the electrodes 4 can be positioned at least at the location corresponding to the maximum diameter of the substrate 3. That is, within the two interlocking spherical structures of the predetermined first and second shapes, there is a difference in diameter between the two predetermined shapes at different cross-sections along the axis of the catheter, and the size of the difference may also vary. As long as the maximum diameters of the two predetermined shapes are ultimately the same, the substrates 3 in the two layers of the predetermined shapes can be evenly arranged to form a circle on plane A at the location of the maximum diameter. In the second state, the deformation degree of the second substrate 32 is greater than that of the first substrate 31, so that the maximum diameter of the predetermined second shape formed is the same as the maximum diameter of the predetermined first shape formed, and the first substrate 31 and the second substrate 32 are arranged in an alternating manner. When the electrode 4 is arranged on the first substrate 31 and the second substrate 32 at this position, the density of the electrode 4 arrangement is increased, and the circumferential arrangement ensures that the field formed by the electrode 4 in the circumferential direction is uniform, ensuring a uniform ablation effect, and one-time ablation can be achieved without rotating the electrode, thereby improving the ablation efficiency.

[0046] In order to achieve better ablation effect and to achieve better uniformity between the electrodes 4 with the largest diameters on different layers of substrates 3, the second substrate 32 needs to be located in the middle of the two first substrates 31 along the radial direction on the basis of the staggered arrangement of the first substrate 31 and the second substrate 32.

[0047] The provided base 3 may include a metal wire and an insulating layer, with the insulating layer covering the outer wall of the metal wire, so that the base 3 can have a certain degree of support stability, a certain degree of deformation ability to switch between the first state and the second state, and can be insulated from the electrode 4. Alternatively, the base 3 can also be a non-metallic, non-conductive member with deformation ability, which is not specifically limited here.

[0048] In one embodiment, if Figure 1 、 Figure 2 、 Figure 3 and Figure 4As shown, along the length direction of the substrate 3, the sum of the cross-sectional areas of the substrate 3 is a predetermined area, and the cross-sectional area of ​​the substrate 3 includes at least one of an ellipse and a polygon. In the above-mentioned arrangement of the substrate 3 in the receiving channel 11 as a structural arrangement of at least two layers, and in order to be able to arrange multiple layers of substrates 3 in the limited space of the receiving channel 11, the cross-sectional area of ​​the substrate 3 can be set to a variety of different shapes to fully utilize the gaps between the substrates 3, thereby increasing the number of substrates 3 arranged in the receiving channel 11. For example, the substrate 3 can be set to an elliptical structure, with the narrower width of the ellipse arranged in the radial direction of the conduit, so that there is space to accommodate more layers of substrates 3, thereby increasing the number of substrates 3 arranged. Alternatively, it can also be set to a polygonal structure such as a sheet, a wave, a square, etc., which is not specifically limited here.

[0049] It is understood that no matter what structure the substrate 3 is made into to match the arrangement of the multi-layer substrate, in order to ensure that more electrodes 4 can be arranged to improve the ablation efficiency, the ratio of the sum of the cross-sectional areas of the substrates 3 to the cross-sectional area of ​​the accommodating channel 11 is greater than 65%. As many substrates 3 as possible are arranged within the limited cross-sectional area of ​​the accommodating channel 11. The shape of the substrate 3 can be adaptively designed according to the number of substrates to be arranged and the size of the substrate 3 relative to the cross-sectional area of ​​the accommodating channel 11. For example, when the substrate 3 is arranged as follows: Figure 2 In the case of an elliptical structure and a double-layer substrate layout, the ratio of the sum of the cross-sectional area of ​​the substrate 3 to the cross-sectional area of ​​the accommodating channel 11 is approximately 70%, which can fully utilize the space of the accommodating channel 11. Depending on the requirements for ablation efficiency in different scenarios, the shape of the substrate 3 can be adaptively adjusted to fully utilize the limited space to install more electrodes and improve ablation efficiency. This is not specifically limited here.

[0050] For the electrode 4 provided on the substrate 3, the electrode 4 is in a ring-shaped structure and is sleeved on different layers of the substrate 3. The ring-shaped structure provided can be a ring adapted to the cross-sectional shape of the substrate 3, or a circular ring electrode 4 can be directly sleeved to save costs. As long as the cross-sectional area of ​​the ring electrode 4 meets the requirements to ensure the ablation effect, no specific limitation is made here. When the electrode 4 is provided as a ring-shaped structure adapted to the cross-sectional shape of the substrate 3, in order to achieve a multi-layer arrangement, the substrate 3 has a circumferential length greater than a radial width in the circumferential direction of the substrate 3 when arranged circumferentially around the catheter, forming an elliptical structure, which is beneficial to increasing the effective area of ​​the electrode 4 for ablation and increasing the efficiency of ablation. Therefore, for the electrode 4 provided on the substrate 3, it is better to provide a non-circular structure.

[0051] When multiple electrodes 4 are arranged on different layers of the substrate 3, in addition to arranging the electrodes 4 at the maximum diameter position enclosed between different layers so that the electrodes 4 form a uniformly arranged annular structure in the axial cross section, the electrodes 4 can also be arranged at other positions on the substrate 3. For example, the electrodes 4 can be arranged at a position closer to the catheter end relative to the maximum diameter position in the outermost layer of the substrate 3 to increase the ablation area of ​​the electrodes 4. Alternatively, the electrodes 4 can be arranged at other positions, which are not specifically limited here.

[0052] To enable electrodes 4 to produce an ablation effect, electrodes 4 are electrically connected to a power supply at the end of the catheter via a wire, which provides energy to the electrodes. It is understood that each pair of adjacent electrodes 4 can be used as an electrode pair. An electrode pair consists of one electrode being assigned a positive electrode and the other a negative electrode via a power supply. The interaction between the positive and negative electrodes forms a field, thereby achieving ablation of the human body part within the field range. The specific implementation method is not described in detail here.

[0053] Optionally, the base 3 may further include a third base. This third base is located within the second base 32 along the mating direction of the inner tube 2 and outer tube 1. Multiple third bases are spaced apart around the accommodating channel at a third diameter, with the gaps between adjacent second bases 32 being greater than the gaps between adjacent third bases. In other words, a third layer, or even more layers, may be provided in addition to the two-layer arrangement described above. The multi-layer arrangement of the bases within the accommodating channel 11 is related to the shape of the base 3 and can be adaptively adjusted based on actual conditions, as long as the total area of ​​the arranged bases 3 ultimately accounts for at least 65 percent of the cross-sectional area of ​​the accommodating channel 11. This is not specifically limited herein.

[0054] In one embodiment, if Figure 5 、 Figure 6 、 Figure 7 and Figure 8As shown, a connecting component 6 is provided at the end of the inner tube 2 extending from the outer tube 1. The connecting component 6 includes a first connecting portion 62 and a second connecting portion 61 arranged sequentially along the axial direction. The first connecting portion 62 is located on the side of the second connecting portion 61 away from the outer tube 1. A preset distance M is provided between the first connecting portion 62 and the second connecting portion 61. The end of the first substrate 31 is fixedly connected to the first connecting portion 62, and the end of the second substrate 32 is fixedly connected to the second connecting portion 61. When the electrode assembly is connected to the inner tube 2 and the outer tube 1, respectively, the ends of the substrate 3 along the length direction are fixedly connected to the inner tube 2 and the outer tube 1, respectively, so that in the first state, the distance that the inner tube 2 extends out of the outer tube 1 is a first distance. Most of the base 3 extends beyond the outer tube 1, with only one end extending into and fixedly connected to the inner wall of the outer tube 1. At the other end of the base 3, the second base 32 located in the inner layer is fixedly connected to the second connecting portion 61, while the first base 31 located in the outer layer is fixedly connected to the first connecting portion 62. This allows the deformable length of the first base 31 to be greater than the deformable length of the second base 32, and the extension direction of the base 3 is parallel to the axis of the catheter. When transitioning from the first state to the second state, as the first distance the inner tube 2 extends from the outer tube 1 decreases, the first base 31 and the second base 32 bend and deform accordingly. When the inner tube 2 extends from the outer tube 2 to the second distance, the second state is reached. In this state, since the first base 31 and the second base 32 have been pre-processed before installation in the catheter, they bend along the pre-processed shape to form the corresponding predetermined first and second shapes.

[0055] Optionally, the preset distance M can be adaptively adjusted based on the preset shape. The preset distance M defines the size of the preset shape that can be formed in the second state and the specific shape's outer shape, which is not specifically limited here. Regarding the preset shapes of the different layers, since there is a preset distance M between the connection points where the base 3 connects to one end of the inner tube 2, when forming the preset shape, the preset shapes formed by the different layers of sleeves are not necessarily symmetrical along the axial direction of the catheter. For example, to ensure that the electrodes 4 at the maximum diameter positions of different layers are located in the same plane A in an annular shape, the outermost layer of the base 3 can be configured in a symmetrically curved form during the preset processing, so that the maximum diameter is located in the middle of the base 3. On this basis, the inner layer of the base 3 can be pre-shaped into the curved shape of the inner layer base 3 based on the preset shape of the outermost layer, so that the electrodes 4 at the maximum diameter positions of different layers are located in the same plane A and are evenly arranged in the same annular shape.

[0056] It is understood that when the multi-layered substrate 3 is fixedly connected to the inner wall of the outer tube 1, both the inner and outer layers of the substrate 3 can be welded to the inner wall of the outer tube 1. Since the gaps between the substrate 3 layers are very small and may even be close together in the first state, when the ends of the substrate 3 are connected to the inner wall of the outer tube 1, they can be directly fixed by welding without the assistance of additional connectors. It should be emphasized that the specific method for fixing the multi-layered substrate 3 to the inner wall of the outer tube 1 is not limited to welding. For example, it can also be in the form of bonding, snap-fit ​​connection, etc., which is not specifically limited here.

[0057] In one embodiment, as the preset distance M increases, the degree of deformation of the second base 32 increases. To meet the requirement that different layers have the same maximum diameter and are located in the same plane A, when different layers have different base 3 lengths, a larger preset distance M indicates a shorter base 3 in the inner layer, and a greater degree of deformation is required to meet the required bending requirements. This is an adaptive adjustment based on different needs and is not specifically limited here.

[0058] In one embodiment, if Figure 5 and Figure 7 As shown, the electrophysiology catheter also includes an adjustment portion 5, which connects the inner tube 2 and the outer tube 1 and is used to drive the inner tube 2 to move in the axial direction relative to the outer tube 1, so as to switch the base 3 between the first state and the second state. Specifically, the adjustment portion 5 is provided at the tail end of the electrophysiology catheter. The adjustment portion 5 includes a button and a sliding assembly that slidably connects the inner tube 2 and the outer tube 1. Pushing the button can drive the sliding assembly to produce a coordinated movement, thereby driving the inner tube 2 to move axially relative to the outer tube 1. The adjustment portion 5 can control the movement of the inner tube 2 in the axial direction relative to the outer tube 1, thereby driving the electrode assembly provided at the end of the electrophysiology catheter to switch between the first state and the second state.

[0059] Optionally, the provided button may also be electrically connected to a power source, and the button switch can be automatically controlled by the power source to control the conversion of the electrode assembly between the first state and the second state, which is not specifically limited here.

[0060] The embodiments of the present application have been described above. The above description is illustrative and not exhaustive, and is not limited to the disclosed embodiments. Many modifications and variations will be apparent to those skilled in the art without departing from the scope and spirit of the described embodiments. The terminology used herein is selected to best explain the principles of the embodiments, their practical applications, or improvements to the technology in the market, or to enable other persons skilled in the art to understand the embodiments disclosed herein.

Claims

1. An electrophysiological catheter, characterized in that The electrode assembly comprises an inner tube and an outer tube which are sleeved together, wherein an annular accommodating channel is provided between the inner tube and the outer tube, and the electrode assembly at least partially extends into the accommodating channel. The electrode assembly comprises: a plurality of bases, each of which is deformable and connected to the inner tube and the outer tube at both ends along the length direction, the bases comprising at least a first base and a second base. In a cross section of the electrophysiological catheter, the bases are located in the accommodating channel. A plurality of the first bases are arranged circumferentially around the accommodating channel with a first diameter. A plurality of the second bases are arranged circumferentially around the accommodating channel with a second diameter, the second diameter being smaller than the first diameter. In a radial direction, the second bases are at least partially located between two adjacent first bases. At least one electrode is connected to the substrate, and a plurality of electrodes are arranged along the length direction of the substrate.

2. The electrophysiological catheter according to claim 1, wherein Along the fitting direction of the inner tube and the outer tube, the first substrate is located on the outer layer of the second substrate. A plurality of the first bases and a plurality of the second bases are respectively arranged at intervals around the circumference of the accommodating channel, and a gap between adjacent first bases is larger than a gap between adjacent second bases.

3. The electrophysiological catheter according to claim 1, wherein Along the length direction of the substrate, the sum of the areas of the cross sections of the substrate is a preset area, and the cross section of the substrate includes at least one of an ellipse and a polygon.

4. The electrophysiological catheter according to claim 1, wherein The ratio of the sum of the cross-sectional areas of the substrates to the cross-sectional area of ​​the accommodating channel is greater than sixty-five percent.

5. The electrophysiological catheter according to claim 2, characterized in that The base also includes a third base. Along the fitting direction of the inner tube and the outer tube, the third base is located in the inner layer of the second base. A plurality of the third bases are arranged around the accommodating channel at intervals of a third diameter, and the gap between adjacent second bases is larger than the gap between adjacent third bases.

6. The electrophysiological catheter according to any one of claims 1 to 5, characterized in that The matrix includes at least a first state and a second state, In the first state, the length direction of the base is parallel to the axial direction of the electrophysiological catheter, and at least a portion of the base extends into the accommodating channel; In the second state, the two ends of the substrate in the length direction are close to each other, and the substrate can be deformed, so that multiple first substrates and multiple second substrates form a preset first shape and a preset second shape respectively, and the planes formed by the maximum diameters of the preset first shape and the preset second shape are located in the same plane, and the electrode is at least arranged at the position corresponding to the maximum diameter of the substrate.

7. The electrophysiological catheter according to claim 6, characterized in that In the second state, the deformation degree of the second substrate is greater than that of the first substrate, so that the maximum diameter of the preset second shape formed is the same as the maximum diameter of the preset first shape formed, and the first substrate and the second substrate are arranged in an alternating manner.

8. The electrophysiological catheter according to claim 6, characterized in that The end of the inner tube extending out of the outer tube is provided with a connecting component, the connecting component including a first connecting portion and a second connecting portion arranged in sequence along the axial direction, the first connecting portion is located on a side of the second connecting portion away from the outer tube, and a preset distance is provided between the first connecting portion and the second connecting portion. An end portion of the first base is fixedly connected to the first connecting portion, and an end portion of the second base is fixedly connected to the second connecting portion.

9. The electrophysiological catheter according to claim 8, characterized in that As the preset distance increases, the deformation degree of the second substrate increases.

10. The electrophysiological catheter according to claim 6, characterized in that The electrophysiological catheter further includes an adjusting portion, which connects the inner tube and the outer tube and is used to drive the inner tube to move relative to the outer tube in an axial direction, so that the base body switches between the first state and the second state.

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