Electrophysiology catheter and electrophysiology equipment

Abstract

The invention discloses an electrophysiology catheter and electrophysiology equipment, and relates to the technical field of medical instruments. A plurality of electrodes of the electrophysiology catheter are arranged at the far end of a catheter body; the bending adjusting driving part is embedded in the far end of the catheter main body, the bending adjusting driving part is provided with a set bending shape through pre-shaping treatment, and the bending adjusting driving part can generate elastic deformation; the bending adjusting mechanism is connected with the bending adjusting driving piece, and the bending adjusting mechanism is used for applying force to the bending adjusting driving piece so as to prevent the bending adjusting driving piece from being recovered to the set bending form; and when the bending adjusting mechanism reduces the force applied to the bending adjusting driving piece, the bending adjusting driving piece gradually and actively recovers to the set bending form, and the far end of the catheter main body adaptively deforms along with the form of the bending adjusting driving piece so as to adjust the distances and / or angles among the electrodes. According to the electrophysiology catheter, the preset bending adjusting driving piece is utilized, the problem that a traditional electrophysiology catheter is unstable in bending shape is effectively solved, and the controllability and mapping accuracy of the catheter are improved.

Description

Technical Field

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

[0002] Electrophysiology catheters include mapping and ablation functions, including collecting electrophysiological signals from the heart and applying energy to facilitate the diagnosis and / or treatment of heart diseases such as arrhythmias.

[0003] In practice, the inventors found that the electrophysiological catheter in the prior art has the following defects:

[0004] The electrophysiological catheter is passively bent under the pull of the pull wire. In this bending mode, the bending shape of the catheter is unstable. At the same time, additional structures are required to guide and support the pull wire, which increases the difficulty of catheter design and processing. In addition, in the existing electrophysiological mapping process, different types of electrophysiological catheters often need to be replaced multiple times to meet the clinical needs of different parts, and the scope of application is relatively limited. Summary of the invention

[0005] The purpose of the present application is to provide an electrophysiological catheter to overcome at least one problem existing in the prior art. Another purpose of the present application is to provide an electrophysiological device.

[0006] To achieve the above objectives, the present application provides an electrophysiological catheter, comprising:

[0007] a catheter body;

[0008] a plurality of electrodes, a plurality of said electrodes being disposed on the distal end of said catheter body;

[0009] A bending drive member is embedded in the distal end of the catheter body, the bending drive member has a set bending shape through a pre-forming process, and the bending drive member can undergo elastic deformation;

[0010] A bending adjustment mechanism connected to the bending adjustment drive member, the bending adjustment mechanism is used to apply force to the bending adjustment drive member to inhibit the bending adjustment drive member from returning to the set bending state;

[0011] When the bending mechanism reduces the force applied to the bending drive member, the bending drive member gradually and actively restores to the set bending state, and the distal end of the catheter body adaptively deforms along with the shape of the bending drive member to adjust the distance and / or angle between the multiple electrodes.

[0012] In some embodiments, the bending drive member includes a plurality of telescopic joints connected in sequence, and the telescopic and / or bending of the bending drive member is achieved through deformation of the telescopic joints;

[0013] The distal end of the catheter body is made of a retractable polymer material so as to follow the bending drive component to perform retraction and / or bending deformation.

[0014] In some embodiments, the force applied by the bending adjustment mechanism to the bending adjustment drive member is a pulling force;

[0015] When the bending drive member is in a tensioned state, the catheter body is in a first state;

[0016] When the bending drive member is not subjected to force, the bending drive member returns to the set bending state, and the catheter body is in the second state;

[0017] The curvature of the catheter body in the first state is smaller than the curvature of the catheter body in the second state, and the length of the catheter body in the first state is shorter than the length of the catheter body in the second state.

[0018] In some embodiments, the bending drive member is composed of bending segments with different set bending shapes; or,

[0019] There are multiple bending adjustment drive members, and the multiple bending adjustment drive members are distributed along the axial direction of the catheter body. The bending adjustment mechanism has traction members corresponding to the number of the bending adjustment drive members. The bending adjustment drive members are connected to the traction members one by one. One or more of the traction members remove the force applied to the bending adjustment drive members to make the catheter body present a different overall bending shape.

[0020] In some embodiments, the bending adjustment mechanism includes a handle and a traction member, the handle is connected to the proximal end of the catheter body, the proximal end of the traction member is connected to the handle, the distal end of the traction member enters the catheter body and is connected to the bending adjustment drive member, and the handle controls the traction member to apply force to the bending adjustment drive member, thereby changing the bending shape of the bending adjustment drive member.

[0021] In some embodiments, the handle includes a push button, a push rod, a limit slot and a seat body, and the traction member is a pull wire;

[0022] The proximal end of the catheter body is fixedly connected to the seat body;

[0023] The push button is connected to the push rod, the push rod is connected to the pull wire, and the push rod extends into the limiting groove and is slidably connected to the limiting groove;

[0024] The pull wire slides with the push rod and expands and contracts relative to the catheter body to change the force applied to the bending drive member.

[0025] In some embodiments, the limiting groove has a plurality of axially distributed locking positions, and the locking positions are engaged with the push rod to inhibit the bending adjustment driving member from returning to the set bending state.

[0026] In some embodiments, the bending adjustment mechanism includes a traction member and a sheath;

[0027] The traction member is connected to the bending adjustment drive member;

[0028] The sheath is arranged at the proximal end of the bending drive component, the sheath is sleeved outside the traction component, and the sheath member can undergo elastic deformation.

[0029] In some embodiments, the plurality of electrodes include a head electrode and a plurality of ring electrodes, the head electrode being disposed at the head end of the distal end of the catheter body, and the plurality of ring electrodes being spaced apart and disposed along the distal end of the catheter body.

[0030] The present application also provides an electrophysiological device, including an electrophysiological system and the above-mentioned electrophysiological catheter, wherein the electrophysiological system is signal-connected to the electrophysiological catheter to obtain an electrical signal from a contact portion of the electrophysiological catheter.

[0031] Compared with the above-mentioned background technology, the electrophysiological catheter provided in the present application mainly includes a catheter body, an electrode, a bending adjustment drive and a bending adjustment mechanism; a plurality of electrodes are arranged on the distal end of the catheter body; the bending adjustment drive is embedded in the distal end of the catheter body, the bending adjustment drive has a set bending shape through a pre-forming process, and the bending adjustment drive can undergo elastic deformation; the bending adjustment mechanism is connected to the bending adjustment drive, and the bending adjustment mechanism is used to apply force to the bending adjustment drive to inhibit the bending adjustment drive from returning to the set bending shape; when the bending adjustment mechanism reduces the force applied to the bending adjustment drive, the bending adjustment drive gradually and actively returns to the set bending shape, and the distal end of the catheter body adaptively deforms according to the shape of the bending adjustment drive to adjust the distance and / or angle between the multiple electrodes.

[0032] In the design of traditional electrophysiology catheters, the stability of the catheter's bend is a key technical problem, which directly affects the catheter's operating accuracy and safety in the heart. The electrophysiology catheter technical solution provided in this application effectively solves this problem through the innovative design of the bend adjustment drive and the bend adjustment mechanism.

[0033] The core innovation of this electrophysiological catheter lies in its bending drive, which is embedded in the distal end of the catheter body and has a set bending shape through pre-forming. This pre-forming process enables the bending drive to elastically deform when the force changes, thereby actively adjusting the bending shape of the catheter. The bending mechanism is connected to the bending drive and is responsible for applying force to the bending drive to control its bending shape. When the bending mechanism reduces the force, the bending drive will gradually return to its preset bending shape, thereby causing the distal end of the catheter body to deform adaptively and adjust one or both of the distance and angle between the electrodes.

[0034] This design makes the catheter's bending control more precise and flexible, and no longer relies solely on the control of any pull wire or support structure, thereby simplifying the catheter's structure and improving its maneuverability and mapping accuracy. Through the pre-shaped bending drive, the catheter can actively return to the set bending state. This feature significantly improves the stability and reliability of the catheter's navigation within the heart, allowing doctors to more accurately position electrodes in complex cardiac anatomy and perform effective electrophysiological signal mapping and / or ablation. In addition, because the catheter actively adjusts its bending shape through the pre-shaped bending drive, the catheter can present different bending shapes and adjust the spacing between electrodes, which can more flexibly and widely meet the catheter needs in the field of electrophysiology, and adapt to the mapping and / or ablation purposes of multiple parts during operation.

[0035] Combined with the above structure and process description, it can be seen that the EP catheter has at least the following beneficial effects: the EP catheter utilizes a predetermined bending drive component to effectively solve the problem of unstable bending of traditional EP catheters, improves the catheter's maneuverability and mapping accuracy, and is suitable for mapping and / or ablation purposes of multiple locations. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on the provided drawings without paying any creative work.

[0037] Figure 1 A schematic diagram of an electrophysiological catheter provided in an embodiment of the present application that has not returned to a set bending state;

[0038] Figure 2 A schematic diagram of an electrophysiological catheter provided in an embodiment of the present application returning to a set curved state;

[0039] Figure 3 A schematic diagram of a bending drive member provided in an embodiment of the present application that has not returned to a set bending state;

[0040] Figure 4 A schematic diagram of the bending drive member provided in an embodiment of the present application returning to a set bending state;

[0041] Figure 5 A schematic diagram of a catheter body provided in an embodiment of the present application that has not returned to a set bending state;

[0042] Figure 6 A schematic diagram of the catheter body provided in an embodiment of the present application returning to a set curved state;

[0043] Figure 7 AA schematic diagram of the catheter body provided in an embodiment of the present application;

[0044] Figure 8 A BB schematic diagram of a catheter body provided in an embodiment of the present application;

[0045] Fig. 9 A schematic diagram of a bending adjustment mechanism provided in an embodiment of the present application;

[0046] Fig.10 A first schematic diagram of the bending drive member after assembly provided in an embodiment of the present application;

[0047] Fig.11 A second schematic diagram of the bending drive member provided in an embodiment of the present application after assembly;

[0048] Fig.12 This is a third schematic diagram of the bending drive component after assembly provided in an embodiment of the present application.

[0049] in:

[0050] Catheter body 1, adjustable bend section 11, main section 12,

[0051] Electrode 2, head electrode 21, ring electrode 22, first ring electrode 221, second ring electrode 222, third ring electrode 223, wire 23,

[0052] The bending drive member 3, the telescopic joint 31, the transition section 32, the first bending drive member 301, the second bending drive member 302,

[0053] The bending adjustment mechanism 4 , the handle 41 , the push button 411 , the push rod 412 , the limiting groove 413 , the seat body 414 , the fixing seat 415 , and the traction member 42 . DETAILED DESCRIPTION

[0054] The following will be combined with the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0055] In order to enable those skilled in the art to better understand the present application, the present application is further described in detail below in conjunction with the accompanying drawings and specific embodiments. For the distal end and proximal end in the specific embodiments, the distal end refers to the part of the corresponding component away from the operator, usually the end of the component entering the patient's body or the surgical area, and the proximal end refers to the part of the corresponding component close to the operator, usually the end held or operated by the operator. For a single component, the end closer to the operator is the proximal end, and the end farther away from the operator is the distal end.

[0056] Please refer to Figure 1 and Figure 2 , Figure 1 A schematic diagram of an electrophysiological catheter provided in an embodiment of the present application that has not returned to a set bending state, Figure 2 A schematic diagram of an electrophysiological catheter provided in an embodiment of the present application returning to a set curved shape.

[0057] In a first specific embodiment, the electrophysiological catheter provided in the embodiment of the present application mainly includes a catheter body 1, an electrode 2, a bending adjustment drive 3 and a bending adjustment mechanism 4.

[0058] A plurality of electrodes 2 are arranged on the distal end of the catheter body 1; a bending adjustment drive member 3 is embedded in the distal end of the catheter body 1, and the bending adjustment drive member 3 has a set bending shape through a pre-forming process, and the bending adjustment drive member 3 can undergo elastic deformation; a bending adjustment mechanism 4 is connected to the bending adjustment drive member 3, and the bending adjustment mechanism 4 is used to apply force to the bending adjustment drive member 3 to inhibit the bending adjustment drive member 3 from returning to the set bending shape.

[0059] When the bending mechanism 4 reduces the force applied to the bending drive 3, the bending drive 3 gradually and actively restores to the set bending state, and the distal end of the catheter body 1 adaptively deforms according to the shape of the bending drive 3 to adjust the distance and / or angle between the multiple electrodes 2.

[0060] For ease of understanding, the following text uses the mapping function of an electrophysiology catheter as an example for explanation, but the catheter of this application does not limit the application of electrophysiology catheters in the diagnosis and treatment of heart diseases such as arrhythmias. In the field of cardiac electrophysiology, the electrocardiogram (ECG) signal at that location is mapped by contacting the electrode with specific tissues in the heart, such as the coronary sinus, the bundle of His, the inner wall of the atrium or the inner wall of the ventricle, and then the corresponding disease diagnosis is performed. The number of electrodes in a conventional electrophysiology mapping catheter is 4 to 20, and the following diagram uses 4 mapping electrodes as an example for illustration, but it is not a limitation or exclusion of the number of electrodes in this application. Among them, the electrode 2 and the bending drive 3 are both arranged on the adjustable bending section at the distal end of the catheter.

[0061] In the design of traditional electrophysiological catheters, the stability of the catheter's bend is a key technical problem, which directly affects the catheter's operating accuracy and safety in the heart. The electrophysiological catheter technical solution provided in this application effectively solves this problem through the innovative design of the bend adjustment drive 3 and the bend adjustment mechanism 4.

[0062] The core innovation of this electrophysiological catheter lies in its bending drive 3, which is embedded in the distal end of the catheter body 1 and has a set bending shape through a pre-forming process. This pre-forming process enables the bending drive 3 to undergo elastic deformation when the force changes, thereby actively adjusting the bending shape of the catheter. The bending mechanism 4 is connected to the bending drive 3 and is responsible for applying force to the bending drive 3 to control its bending shape. When the bending mechanism 4 reduces the force, the bending drive 3 will gradually return to its preset bending shape, thereby causing the distal end of the catheter body 1 to deform adaptively and adjust one or both of the distance and angle between the electrodes 2.

[0063] This design makes the catheter's bending control more precise and flexible, and no longer relies solely on any pull wire or support structure, thereby simplifying the catheter's structure and improving its maneuverability and mapping accuracy. Through the pre-shaped bending drive 3, the catheter can actively return to the set bending state. This feature significantly improves the stability and reliability of the catheter's navigation within the heart, allowing doctors to more accurately position the electrode 2 in the complex cardiac anatomical structure and perform effective electrophysiological signal mapping and / or ablation. In addition, because the catheter actively adjusts the bending shape through the pre-shaped bending drive, the catheter can present different bending shapes and adjust the spacing between electrodes, which can more flexibly and widely meet the catheter needs in the field of electrophysiology, and adapt to the mapping and / or ablation purposes of multiple parts during operation.

[0064] Combined with the above structure and process description, it can be seen that the electrophysiology catheter has at least the following beneficial effects: the electrophysiology catheter utilizes a predetermined bending drive 3 to effectively solve the problem of unstable bending of traditional electrophysiology catheters, improves the catheter's maneuverability and mapping accuracy, and is suitable for mapping and / or ablation purposes of multiple locations.

[0065] It should be noted that the electrophysiological catheter provided in this embodiment adopts a new bending mechanism, specifically an electrophysiological catheter with a new bending mechanism. The electrophysiological catheter realizes the change of bending shape through the bending drive 3 inside the catheter body 1, which can realize diversified bending control and precise bending control.

[0066] In some cases, the bending drive 3 can be an elastic mechanism embedded in the catheter body 1. The catheter body 1 is tightly connected to the elastic mechanism and changes synchronously. The elastic mechanism provides the driving force for the bending change of the catheter body 1. Although the bending mechanism 4 plays an inhibitory control on the elastic mechanism, the driving source of the bending change of the electrophysiological catheter is actually the elastic mechanism. Through the pre-forming treatment of the elastic mechanism, the elastic mechanism is shaped into an elongated state, a bent state, or a combination of the two. The elastic mechanism is compressed, deflected, or a combination of the two under the force of the bending mechanism 4. The force of the bending mechanism 4 is changed so that the elastic mechanism can finally reach the set bending state of the pre-forming treatment.

[0067] The elastic mechanism can be a helical spring or a grooved hypotube. The helical spring is formed by winding a round wire or a flat wire, or by continuous cutting of a tube. In addition, the grooved hypotube is generally formed by discontinuous cutting of the tube. The predetermined shape of the bending drive member 3 can be as follows: Figure 1 , Figure 2 , Figure 3 or Figure 4 As for the shape and curvature of the distal end of the catheter shown in any one of the figures, those skilled in the art will appreciate that the predetermined shape is not limited to the types illustrated in the figures, but can be adjusted according to actual needs, and all of them fall within the scope of protection of the present application.

[0068] Optionally, the elastic mechanism may be made of nickel-titanium alloy, and the elastic mechanism may be pre-shaped to control its bending shape during expansion and contraction to meet the bending shape required for the catheter to bend. Specifically, during the pre-shaped process, the nickel-titanium alloy is wound in a wire-like structure onto a shaping mold having a predetermined bending shape, and then shaped into the set bending shape by heating.

[0069] In some embodiments, baffles (not shown) are provided at both the distal end and the proximal end of the elastic mechanism. The baffles are made of hard material and can be metal structural parts or glue fixing blocks with a certain strength. The bending mechanism 4 is connected to the baffles. The baffle at the distal end reserves a passage space for the wire 23, and the baffle at the proximal end reserves a passage space for the wire 23 and the traction member 42. The traction member 42 is connected to the baffle at the distal end, and the traction member 42 applies force to the elastic mechanism.

[0070] Please refer to Figure 3 and Figure 4 , Figure 3This is a schematic diagram of a bending drive member provided in an embodiment of the present application that has not returned to a set bending state. Figure 4 A schematic diagram of a bending drive member provided in an embodiment of the present application returning to a set bending state.

[0071] In some embodiments, the bending drive member 3 includes a plurality of telescopic joints 31 connected in sequence, and the telescopic and / or bending of the bending drive member 3 is achieved by deformation of the telescopic joints 31;

[0072] The distal end of the catheter body 1 is made of a retractable polymer material so as to follow the bending drive member 3 to perform retraction and / or bending deformation.

[0073] In this embodiment, the design of the bending drive member 3 is the core component of the electrophysiological catheter, which includes a plurality of telescopic joints 31 connected in sequence. These telescopic joints 31 enable the bending drive member 3 to achieve telescoping and / or bending through their own deformation ability, thereby finely adjusting the bending shape of the catheter body 1 to adapt to different surgical operation requirements and body structures.

[0074] The distal end of the catheter body 1 is made of a retractable polymer material, which enables the catheter body 1 to be retracted and / or bent synchronously with the bending drive 3. This synchronous deformation capability is crucial for electrophysiological catheters because it allows the catheter to better adapt to the changing paths and target locations in the body while maintaining coordinated movement with the bending drive 3.

[0075] It should be understood that compared with the prior art that relies on the pull wire to achieve the bending of the catheter, it drags the distal end of the catheter to yield and then present a bent shape by changing the length of the pull wire in the catheter, that is, the change in the shape of the catheter depends on the change in the telescopic length of the pull wire, so that the catheter body itself only bends and deforms during the process without stretching and telescoping. The linear distance between the electrodes in the prior art is only affected by the bending angle, and in fact, the axial spacing between two adjacent electrodes along the bending trajectory of the catheter does not change significantly. Based on this, the material of the distal end of the catheter in the prior art is not specially considered. Accordingly, although the electrophysiological catheter in the prior art has a certain bending function, its application range is narrow, resulting in the operator needing to replace the catheter multiple times or combine multiple catheters during actual clinical operations to achieve clinical purposes. In contrast, the present application uses the bending drive member 3 as the power source for driving the bending of the catheter. The various types of structures of the bending drive members listed above can bend and expand and contract at the same time, that is, the bending shape of the distal end of the catheter changes while the length of the adjustable bend section of the distal end of the catheter changes. The straight-line distance between the electrodes is not only affected by the bending angle, but also the axial spacing between two adjacent electrodes along the bending trajectory of the catheter changes synchronously. Based on this, the material of the distal end of the catheter of the present application is a polymer with good elasticity and compliance. Therefore, the present application can not only adjust the bending shape of the distal end of the catheter but also adjust the length of the adjustable bend section of the distal end of the catheter, so that the distribution of each electrode is more flexible and caters to the clinical needs of the operator. When the bending drive member of the present application returns to the set bending state, the adjustable bending section of the catheter has the maximum length, which is suitable for entering deeper and farther positions in the heart, such as the inside of the coronary sinus ostium. Therefore, the catheter of the present application can reduce the inhibition of the bending drive member to different degrees, so that the bending drive member can actively bend into different bending shapes and telescopic lengths, dynamically adjust the distribution of each electrode at the distal end of the catheter, and adapt to the guidance of multiple parts during mapping or ablation without the need for frequent replacement of the catheter, simplifying the operating steps and increasing the versatility of the catheter.

[0076] This design enables the electrophysiology catheter to more accurately control the position and direction of the catheter tip when performing electrophysiological signal mapping, improving the accuracy and safety of the operation. At the same time, the use of polymer materials also ensures the biocompatibility of the catheter in the body and reduces the risk of surgery.

[0077] In some cases, taking the case where the bending drive member 3 is an elastic mechanism, the shape change of the bending drive member 3 is actually caused by the superposition effect of the telescopic joints 31. Each telescopic joint 31 can be extended and bent independently, but when they are connected in sequence to form the bending drive member 3, their movement combination forms the overall shape change of the bending drive member 3. This design enables the bending drive member 3 to actively bend and / or extend in a precise and controllable manner in accordance with the force applied by the bending mechanism 4.

[0078] When the bending mechanism 4 applies force, the telescopic joints 31 are compressed or extended one by one. This continuous and cumulative change enables the bending drive 3 to achieve complex bending adjustments. When the force applied by the bending mechanism 4 is reduced, the telescopic joints 31 will return to their initial states one by one, so that the bending drive 3 returns to the set bending state after the predetermined shaping process. This morphological change based on the superposition of the telescopic joints 31 provides the electrophysiological catheter with a high degree of flexibility and precise control capability, enabling it to achieve precise positioning and mapping during surgery.

[0079] Please refer to Figure 5 and Figure 6 , Figure 5 A schematic diagram of a catheter body provided in an embodiment of the present application that has not returned to a set bending state, Figure 6 A schematic diagram of the catheter body provided in an embodiment of the present application returning to a set bending state (some electrodes are omitted and not drawn).

[0080] In some embodiments, the force applied by the bending adjustment mechanism 4 to the bending adjustment driving member 3 is a pulling force;

[0081] When the bending drive member 3 is in a tensioned state, the catheter body 1 is in a first state;

[0082] When the bending driving member 3 is not subjected to force, the bending driving member 3 returns to the set bending state, and the catheter body 1 is in the second state;

[0083] The curvature of the catheter body 1 in the first state is smaller than the curvature of the catheter body 1 in the second state, and the length of the catheter body 1 in the first state is shorter than the length of the catheter body 1 in the second state.

[0084] In this embodiment, the bending mechanism 4 controls the state of the bending drive member 3 by applying a pulling force, thereby affecting the shape of the catheter body 1. When the bending mechanism 4 applies a pulling force to the bending drive member 3, the bending drive member 3 is in a tensioned state, causing the catheter body 1 to be transformed into a first state. In this state, the curvature of the catheter body 1 is reduced and the length is shortened. Such a curved shape facilitates the catheter to pass through the sheath or the tortuous tissue of the human body and reach the target site more smoothly.

[0085] On the contrary, when the bending mechanism 4 does not apply force to the bending drive member 3, the bending drive member 3 is not affected by the force and will return to the predetermined bending state according to the elastic characteristics of its material, and the catheter body 1 is transformed into the second state. In the second state, the curvature of the catheter body 1 increases and the length becomes longer. Such a design enables the catheter body 1 to adapt to a wider operating space or enter a more complex target position, has better positioning, and provides more flexibility and adaptability.

[0086] This design allows the electrophysiology catheter to flexibly switch between the two states according to different needs during the operation by adjusting the tension applied by the bending mechanism 4, so as to achieve the best operating effect and the highest surgical safety. This design not only improves the maneuverability of the catheter, but also enables the catheter to better adapt to complex in vivo pathways, providing a more accurate and controllable tool for electrophysiological mapping.

[0087] In some cases, the catheter body 1 includes an adjustable bend section 11 and a main section 12, the adjustable bend section 11 is located at the distal end, the main section 12 is located at the proximal end, the bend drive 3 is embedded in the adjustable bend section 11, and the electrode 2 is disposed in the adjustable bend section 11. The overall hardness of the adjustable bend section 11 is lower than that of the main section 12, and the feature that the adjustable bend section 11 is easier to deform is achieved by differentiating the hardness of the two sections.

[0088] Optionally, the adjustable curved section 11 has a first state and a second state, the curvature of the adjustable curved section 11 in the first state is smaller than that in the second state, and the length in the first state is shorter than the length in the second state.

[0089] The adjustable bending section 11 is made of a stretchable polymer material, and the polymer material should have good biocompatibility, such as Pebax, TPU, PA, etc.

[0090] In a specific implementation, in order to achieve a richer bending shape of the bending drive member 3, different implementations may be used.

[0091] In some embodiments, the bending drive member 3 is composed of bending segments with different set bending shapes.

[0092] In this embodiment, this method involves that the bending drive member 3 is composed of a plurality of bending segments with different set bending shapes. In this way, each bending segment can independently contribute to the overall bending shape of the catheter body 1, so that the catheter body 1 can achieve a variety of bending shapes. This design improves the flexibility and adaptability of the catheter, allowing it to better adapt to complex in vivo structures and surgical paths.

[0093] In some embodiments, there are multiple bending drive members 3, and the multiple bending drive members 3 are distributed along the axial direction of the catheter body 1. The bending mechanism 4 has traction members 42 corresponding to the number of the bending drive members 3. The bending drive members 3 are connected to the traction members 42 one by one. One or more traction members 42 remove the force on the bending drive members 3 to make the catheter body 1 present a different overall bending shape.

[0094] In this embodiment, this method adopts a combination of multiple bending adjustment driving members 3, and realizes diversified bending adjustment of the catheter body 1 by using multiple bending adjustment driving members 3.

[0095] The bending drive members 3 are distributed along the axial direction of the catheter body 1, which means that they are arranged in sequence in the axial direction of the catheter, providing the catheter with multiple bending adjustment areas. The bending mechanism 4 is equipped with traction members 42 equal in number to the bending drive members 3, ensuring that each bending drive member 3 can be connected to a traction member 42 in a one-to-one correspondence. This one-to-one connection allows each bending drive member 3 to be controlled individually. By operating the traction member 42, force can be applied to or removed from a specific bending drive member 3.

[0096] When one or more traction members 42 remove the force applied to the bending drive member 3, the corresponding bending drive member 3 will return to its preset bending state according to the elasticity of its material. This change will cause the catheter body 1 to present a different overall bending shape, thereby achieving precise bending control of the catheter body 1. This design provides a high degree of flexibility, allowing the catheter to adjust its shape to adapt to different operating environments and paths according to specific needs during the operation. In this way, the electrophysiological catheter can reach the target location more accurately, improving the efficiency and safety of the operation.

[0097] Please refer to Figures 10 to 12 ,in, Fig.10 This is a first schematic diagram of the bending drive member provided in the embodiment of the present application after assembly, Fig.11 A second schematic diagram of the bending drive member after assembly provided in an embodiment of the present application, Fig.12 This is a third schematic diagram of the bending drive component after assembly provided in an embodiment of the present application.

[0098] In some cases, a transition section 32 is provided between multiple bending drive members 3 to achieve connection between adjacent bending drive members 3, and the bending drive member 3 at the far end of the transition section 32 will rely on the transition section 32 to produce a bending change. Generally, the ratio of the pitch to the line width of the transition section 32 is 1:1-2:1, and the ratio of the pitch to the line width of the bending drive member 3 is greater than 2:1. The transition section 32 is less sensitive to the force change of the bending mechanism 4 than the bending drive member 3.

[0099] by Figures 10 to 12 For example, there are two bending adjustment drive members 3, including a first bending adjustment drive member 301 and a second bending adjustment drive member 302. The first bending adjustment drive member 301 and the second bending adjustment drive member 302 are connected by a transition section 32. The first bending adjustment drive member 301 is located at the distal end, and the second bending adjustment drive member 302 is located at the proximal end.

[0100] exist Fig.10 In the embodiment, the first bending adjustment driving member 301 at the distal end returns to the set bending state, while the second bending adjustment driving member 302 at the proximal end does not return to the set bending state and is still in a compressed state. At this time, the first bending adjustment driving member 301 and the second bending adjustment driving member 302 form a first bending state.

[0101] exist Fig.11 In the embodiment, the second bending adjustment drive member 302 at the proximal end returns to the set bending state, while the first bending adjustment drive member 301 at the distal end does not return to the set bending state and is still in a compressed state. At this time, the first bending adjustment drive member 301 and the second bending adjustment drive member 302 form a second bending state.

[0102] exist Fig.12 In the embodiment, the first bending adjustment driving member 301 at the distal end and the second bending adjustment driving member 302 at the proximal end are both restored to the set bending state. At this time, the first bending adjustment driving member 301 and the second bending adjustment driving member 302 form a third bending state.

[0103] It should be noted that the above description and drawings show the state and bending shape of any bending drive component when it is fully restored to the set bending state. In actual use, the intermediate state when any bending drive component has not fully restored to the set bending state also makes the distal end of the catheter present different bending states and telescopic states. These several intermediate states are also used as the result of regulating the distal end of the catheter in this application, so that the catheter of the application has a variety of bending states and a high degree of flexibility, so that the catheter can adjust its shape to adapt to different operating environments and paths according to the specific needs during the operation.

[0104] By setting multiple bending drive members 3 in the adjustable bending section 11 and adjusting parameters such as the material, length, cross-sectional size or pitch of the bending drive members 3, a special deformation sequence of the bending drive members 3 during bending can be designed, and the bending shape can be adjusted more flexibly to meet more catheter positioning requirements.

[0105] Please refer to Fig. 9 , Fig. 9 A schematic diagram of a bending adjustment mechanism provided in an embodiment of the present application.

[0106] In some embodiments, the bending mechanism 4 includes a handle 41 and a traction member 42, wherein the handle 41 is connected to the proximal end of the catheter body 1, the proximal end of the traction member 42 is connected to the handle 41, and the distal end of the traction member 42 enters the catheter body 1 and is connected to the bending drive member 3. The handle 41 controls the traction member 42 to apply force to the bending drive member 3, thereby changing the bending shape of the bending drive member 3. Among them, the distal end of the traction member 42 enters the catheter body 1 and is connected to the bending drive member 3. Since the bending drive member 3 is nested with the catheter body 1, the distal end of the traction member 42 enters the inner cavity of the bending drive member 3 and is connected to the inner cavity of the bending drive member 3, so that the traction member 42 is equivalent to the expansion and contraction of the catheter body 2, thereby adjusting the force applied to the bending drive member 3.

[0107] In this embodiment, the handle 41 is located at the proximal end of the catheter body 1, which is convenient for the operator to hold and operate. The proximal end of the traction member 42 is connected to the handle 41, and the distal end thereof extends into the catheter body 1 and is connected to the bending drive member 3.

[0108] By operating the handle 41, the force applied by the traction member 42 to the bending drive member 3 can be controlled. This design allows the operator to accurately adjust the shape of the bending drive member 3 through the external handle 41, thereby changing the bending shape of the catheter body 1. This mechanism enables the electrophysiology catheter to flexibly adjust its shape according to the needs during the operation to adapt to different operating environments and paths.

[0109] In some embodiments, the handle 41 includes a push button 411, a push rod 412, a limit groove 413 and a seat body 414, and the traction member 42 is a pull wire;

[0110] The proximal end of the catheter body 1 is fixedly connected to the seat body 414, and the proximal end of the catheter body and the seat body do not move during the process of the handle applying force to the bending drive member 3;

[0111] The push button 411 is connected to the push rod 412, the push rod 412 is connected to the pull wire, and the push rod 412 extends into the limiting groove 413 and is slidably connected to the limiting groove 413;

[0112] The pull wire slides with the push rod 412 and expands and contracts relative to the catheter body 1 to change the force applied to the bending drive member 3 .

[0113] In this embodiment, the handle 41 is an important component of the bending adjustment mechanism 4, and is composed of several key components: a push button 411, a push rod 412, a limit groove 413, and a seat body 414. These components work together to enable the operator to accurately control the traction member 42, i.e., the pull wire, and thus change the force applied to the bending adjustment drive member 3.

[0114] The proximal end of the catheter body 1 is fixedly connected to the seat body 414, ensuring the stability between the handle 41 and the catheter body 1 and the accuracy of operation. The push button 411 is connected to the push rod 412, and this connection mode allows the operator to control the movement of the push rod 412 through the push button 411. The push rod 412 is connected to the pull wire, so the movement of the push rod 412 can be directly transmitted to the pull wire to achieve control of the pull wire.

[0115] The push rod 412 extends into the limiting groove 413 and is slidably connected with the limiting groove 413. This design allows the push rod 412 to move within a certain range while limiting its excessive movement, thereby ensuring the accuracy and safety of the operation. As the push rod 412 slides in the limiting groove 413, the pull wire will expand and contract accordingly, thereby changing the force applied to the bending drive member 3. This design allows the bending drive member 3 to flexibly adjust its bending shape according to the needs of the surgical process to adapt to different operating environments and paths.

[0116] Particularly, the traction member 42 , ie the pull wire, is connected to the distal end of the bending drive member 3 .

[0117] In some cases, the bending mechanism 4 further includes a fixed seat 415, which is connected to the push rod 412, and the traction member 42, i.e., the pull wire, is connected to the push rod 412 through the fixed seat 415. When the push button 411 and the push rod 412 are pushed, the pull wire is tightened or loosened as the push button 411 and the push rod 412 move, thereby controlling the expansion and contraction of the bending drive member 3. At the same time, since the proximal end of the catheter body 1 is fixed to the seat 414, when the push button 411 and the push rod 412 are pushed, the proximal end of the catheter body 1 will not change with it. When the bending drive member 3 expands and contracts, since the catheter body 1 is made of a retractable polymer material, it will follow the expansion and contraction of the bending drive member 3 to achieve a change in the bending type.

[0118] In some cases, for a single bending drive member 3, the traction members 42, i.e., the pull wires, are arranged in two groups, and the two groups of traction members 42 are symmetrically arranged, preferably at an angle of 180°. The stable extension and retraction of the bending drive member 3 is achieved through the simultaneous action of the two groups of traction members 42.

[0119] In some embodiments, the limit groove 413 has multiple axially distributed locking positions, which are engaged with the push rod 412 to prevent the bending drive member 3 from returning to the set bending state and staying in the current state, which can be any corresponding intermediate state before the bending drive member 3 returns to the set bending state.

[0120] In this embodiment, the limiting groove 413 includes a plurality of axially distributed positions, and the function of these positions is to provide different fixed positions for the push rod 412 under static conditions. Each position can be engaged with the push rod 412 to generate sufficient friction to resist the restoring tension of the bending drive member 3. This design ensures that when not in operation, the bending drive member 3 can maintain its current bending state and will not return to its preset bending state due to the elasticity of the bending drive member 3 itself.

[0121] When the operator needs to adjust the curvature of the catheter body 1, an appropriate thrust is applied to the push button 411, and this thrust is sufficient to overcome the friction provided by the stop groove 413, thereby driving the push rod 412 to slide along the stop groove 413. The sliding of the push rod 412 is transmitted to the traction member 42, that is, the pull wire, thereby changing the force applied to the curvature adjustment drive member 3, thereby adjusting the curvature of the catheter body 1.

[0122] Please refer to Figure 7 and Figure 8 , Figure 7 AA schematic diagram of the catheter body provided in the embodiment of the present application, Figure 8 This is a BB schematic diagram of the catheter body provided in an embodiment of the present application.

[0123] exist Figure 7In the embodiment, the adjustable bending section 11 is a single-cavity structure, and a bending driving member 3 is arranged inside the adjustable bending section 11. There is a small gap or an interference fit between the adjustable bending section 11 and the bending driving member 3. Sufficient space is reserved inside the bending driving member 3 so that the wire 23 and the traction member 42 can be passed through, and the wire 23 is electrically connected to the electrode 2.

[0124] In some embodiments, Figure 8 The main section 12 is a multi-lumen tube structure, which should ensure that it has sufficient support force and hardness when the adjustable bending section 11 is bent. A material with higher hardness or an embedded metal braided layer can be selected. The multiple cavities of the main section 12 pass through the wire 23 and the traction member 42 respectively. In particular, taking the number of traction members 42 as an example, the main section 12 is a three-lumen tube structure, the middle cavity is the wire cavity through which the wire 23 passes, and the cavities on both sides are the wire cavities through which the traction member 42, i.e., the pull wire, passes, and the two pull wire cavities are symmetrically arranged with the wire cavity as the center.

[0125] In some embodiments, the bending adjustment mechanism 4 includes a traction member 42 and a sheath;

[0126] The traction member 42 is connected to the bending drive member 3;

[0127] The sheath is arranged at the proximal end of the bending drive member 3 , the sheath is sleeved outside the traction member 42 of the main body section 12 , and the sheath member can undergo elastic deformation.

[0128] In this embodiment, the design of the bending mechanism 4 not only includes a traction member 42, but also a sheath component. The traction member 42 is directly connected to the bending drive member 3 and is responsible for transmitting the force required for the bending, while the sheath is arranged at the proximal end of the bending drive member 3. Accordingly, the bending drive member 3 is nested in the adjustable bending section 11 at the distal end of the catheter, the main section 12 is connected to the proximal end of the adjustable bending section 11, and the sheath is arranged in the main section 12 and sleeved on the traction member 42. Specifically, it is sleeved on the outside of the traction member 42, i.e., the pull wire, to ensure the centering of the pull wire and prevent the catheter from bending.

[0129] The function of the sheath is to provide additional protection and support for the traction member 42. It can be selected as a spiral spring tube, a polymer sheath, or a combination of the two. The spiral spring tube provides a certain elasticity and support, while the polymer sheath increases wear resistance and protection. Such a design enables the sheath to not only withstand a certain mechanical load, but also adapt to the elastic deformation of the traction member 42 during the bending process.

[0130] The elastic deformation ability of the sheath means that it can remain stable when the traction member 42 is stretched or compressed, reducing friction damage to the catheter body 1 and protecting the traction member 42 from possible influences of the external environment. This design improves the durability and reliability of the bending mechanism 4, while also ensuring the stability and accuracy of the electrophysiological catheter during operation. In this way, the sheath helps maintain the overall performance of the catheter, prolongs its service life, and ensures safety and effectiveness during surgery.

[0131] Please continue to refer to Figure 5 and Figure 6 In some embodiments, the plurality of electrodes 2 include a head electrode 21 and a plurality of ring electrodes 22 , the head electrode 21 is disposed at the head end of the distal end of the catheter body 1 , and the plurality of ring electrodes 22 are spaced apart along the distal end of the catheter body 1 .

[0132] In this embodiment, the electrode system of the electrophysiological catheter is composed of a head electrode 21 and a plurality of ring electrodes 22, which together constitute a plurality of electrodes 2, and the plurality of electrodes are arranged on the adjustable curved section of the catheter. The head electrode 21 is located at the head end of the distal end of the catheter body 1, and the ring electrodes 22 are arranged at intervals along the distal end of the catheter body 1. Such a layout enables the catheter to map electrophysiological signals at different positions.

[0133] In addition, the wire 23 is electrically connected to the plurality of electrodes 2 and is responsible for transmitting the electrophysiological signals detected by the electrodes to the electrophysiological device. The wire 23 passes through the interior of the catheter body 1, especially inside the bending drive 3, and its design cleverly avoids affecting the bending shape of the bending drive 3. This means that even when the catheter body 1 is bent or the bending shape is adjusted, the wire 23 will not interfere with the bending drive 3, thereby ensuring the flexibility and functionality of the catheter.

[0134] In some cases, the ring electrode 22 includes a first ring electrode 221, a second ring electrode 222, and a third ring electrode 223. The spacing between the first ring electrode 221, the second ring electrode 222, and the third ring electrode 223 varies according to the change of the bend. In addition, the ring electrode 22 can also be other numbers, which will not be repeated here.

[0135] In some embodiments, the bending drive is nested in the adjustable bend section at the distal end of the catheter body, and the adjustable bend section can be driven by the bending drive to be C-shaped, L-shaped, J-shaped, P-shaped and S-shaped as a whole. It should be noted that it can be a single bending drive 3 that has a set bend shape including C-shaped, L-shaped, J-shaped, P-shaped and S-shaped through a predetermined shape treatment, or it can be a combination of multiple bending drives 3 and the shape presented as a whole when the bending mechanism 4 removes the force, or the shape presented by the adjustable bend section in any intermediate state, which will not be listed here one by one. It should be noted that the aforementioned bend shape is similar to the aforementioned letter shape presented by the adjustable bend section, which is not inconsistent with the different types of catheters specified in the prior art from multiple aspects such as the adjustable bend length, the adjustable bend radius, and the bend type. For example, the existing catheters with codes A, B, C, D, E, F, K, and J in the prior art are code names for specific adjustable bend lengths, adjustable bend radius, and bend types for distinguishing and using. It should be understood by those skilled in the art that the catheter of the present application presents different shapes and dynamically changes with set bending states and intermediate states, so that due to the structural characteristics and material characteristics of the scheme of the present application, it can present different bending shapes and different telescopic lengths, so that it can switch from a certain code-type catheter in the prior art to another code-type catheter, reducing the number of times that different code-type catheters need to be replaced due to the need to switch shapes and lengths in the prior art, which is more convenient and easy to operate.

[0136] In this embodiment, the design of the bending drive member 3 allows it to obtain specific bending shapes through pre-forming, and these bending shapes include C-type, L-type, J-type, P-type and S-type. Pre-forming is a step in the manufacturing process, which enables the bending drive member 3 to be molded into specific shapes as required and maintain these shapes after the molding force is removed.

[0137] This processing method enables the bending drive member 3 to automatically restore to the preset bending shape when no external force is applied. For example, when the bending mechanism 4 reduces or removes the force applied to the bending drive member 3, the bending drive member 3 can be restored from the compressed or stretched state to the C-shape, L-shape, J-shape, P-shape and S-shape after the preset processing, and the deflection angle is 0° to 270°.

[0138] In a specific embodiment, the process of using an electrophysiological catheter is described as follows.

[0139] The bending drive 3 drives the adjustable bending section 11 of the catheter body 1 to extend in the extended state, so that the adjustable bending section 11 exhibits a larger bending shape, and the spacing between the ring electrodes 22 also increases accordingly, so as to realize real-time adjustment of the bipolar mapping position and range.

[0140] In the initial state of the catheter body 1, the push button 411 and the push rod 412 of the bending mechanism 4 are in a retracted state, which causes the proximal end of the traction member 42 to retract and approach the proximal end of the handle 41. The retraction of the traction member 42 drives the bending drive member 3 connected thereto to contract, so that the bending drive member 3 and the adjustable bending section 11 fixedly connected thereto contract. At this time, the adjustable bending section 11 of the catheter is in a minimum bending state, which facilitates the catheter body 1 to pass through the sheath tube and enter the sheath tube more smoothly.

[0141] When the catheter body 1 is ready to enter a complex target site, the operator can release the traction member 42 by appropriately pushing the push button 411, thereby gradually releasing the bending drive member 3 to a predetermined shape. As the bending drive member 3 is released, the adjustable bending section 11 gradually extends, and its distal end can approach the target site, achieving better positioning of the catheter and facilitating accurate mapping of electrophysiological signals.

[0142] The present application also provides an electrophysiological device, including an electrophysiological system and the above-mentioned electrophysiological catheter, wherein the electrophysiological system is signal-connected to the electrophysiological catheter to obtain an electrical signal from a contact portion of the electrophysiological catheter.

[0143] The electrophysiological device should have all the beneficial technical effects of the above-mentioned electrophysiological catheter, which will not be described in detail here.

[0144] In this embodiment, the electrophysiological system is electrically connected to the lead wire 23 of the electrophysiological catheter, so that the electrophysiological system can obtain the electrical signal of the contact part of the electrophysiological catheter. The design of this electrophysiological device ensures the effective collection and transmission of electrophysiological signals, and can monitor and analyze the electrophysiological activity of the heart in real time.

[0145] It should be noted that many of the components mentioned in this application are universal standard parts or components known to those skilled in the art, and their structures and principles can be learned by those skilled in the art through technical manuals or through conventional experimental methods.

[0146] It should be noted that, in this specification, relational terms such as first and second are merely used to distinguish one entity from other entities, but do not necessarily require or imply any actual relationship or order between these entities.

[0147] The above is a detailed introduction to the electrophysiological catheter and electrophysiological device provided by the present application. Specific examples are used in this article to illustrate the principles and implementation methods of the present application. The description of the above embodiments is only used to help understand the method and core idea of ​​the present application. It should be pointed out that for ordinary technicians in this technical field, without departing from the principles of the present application, several improvements and modifications can be made to the present application, and these improvements and modifications also fall within the scope of protection of the claims of the present application.

Claims

1. An electrophysiological catheter, characterized in that: include: a catheter body; a plurality of electrodes, a plurality of said electrodes being disposed on the distal end of said catheter body; A bending drive member is embedded in the distal end of the catheter body, the bending drive member has a set bending shape through a pre-forming process, and the bending drive member can undergo elastic deformation; A bending adjustment mechanism connected to the bending adjustment drive member, the bending adjustment mechanism is used to apply force to the bending adjustment drive member to inhibit the bending adjustment drive member from returning to the set bending state; When the bending mechanism reduces the force applied to the bending drive member, the bending drive member gradually and actively restores to the set bending state, and the distal end of the catheter body adaptively deforms along with the shape of the bending drive member to adjust the distance and / or angle between the multiple electrodes.

2. The electrophysiological catheter according to claim 1, characterized in that The bending drive member includes a plurality of telescopic joints connected in sequence, and the telescopic and / or bending of the bending drive member is achieved through deformation of the telescopic joints; The distal end of the catheter body is made of a retractable polymer material so as to follow the bending drive component to perform retraction and / or bending deformation.

3. The electrophysiological catheter according to claim 1, characterized in that: The force applied by the bending adjustment mechanism to the bending adjustment drive member is a pulling force; When the bending drive member is in a tensioned state, the catheter body is in a first state; When the bending drive member is not subjected to force, the bending drive member returns to the set bending state, and the catheter body is in the second state; The curvature of the catheter body in the first state is smaller than the curvature of the catheter body in the second state, and the length of the catheter body in the first state is shorter than the length of the catheter body in the second state.

4. The electrophysiological catheter according to claim 1, characterized in that: The bending drive member is composed of bending segments with different set bending shapes; or, There are multiple bending adjustment drive members, and the multiple bending adjustment drive members are distributed along the axial direction of the catheter body. The bending adjustment mechanism has traction members corresponding to the number of the bending adjustment drive members. The bending adjustment drive members are connected to the traction members one by one. One or more of the traction members remove the force applied to the bending adjustment drive members to make the catheter body present a different overall bending shape.

5. The electrophysiological catheter according to claim 1, characterized in that: The bending adjustment mechanism includes a handle and a traction member, the handle is connected to the proximal end of the catheter body, the proximal end of the traction member is connected to the handle, the distal end of the traction member enters the catheter body and is connected to the bending adjustment drive member, and the handle controls the traction member to apply force to the bending adjustment drive member, thereby changing the bending shape of the bending adjustment drive member.

6. The electrophysiological catheter according to claim 5, characterized in that The handle includes a push button, a push rod, a limit groove and a seat body, and the traction member is a pull wire; The proximal end of the catheter body is fixedly connected to the seat body; The push button is connected to the push rod, the push rod is connected to the pull wire, and the push rod extends into the limiting groove and is slidably connected to the limiting groove; The pull wire slides with the push rod and expands and contracts relative to the catheter body to change the force applied to the bending drive member.

7. The electrophysiological catheter according to claim 6, characterized in that: The limiting groove has a plurality of axially distributed locking positions, and the locking positions are engaged with the push rod to inhibit the bending adjustment driving member from returning to the set bending state.

8. The electrophysiological catheter according to claim 1, characterized in that: The bending adjustment mechanism includes a traction member and a sheath; The traction member is connected to the bending adjustment drive member; The sheath is arranged at the proximal end of the bending drive component, the sheath is sleeved outside the traction component, and the sheath member can undergo elastic deformation.

9. The electrophysiological catheter according to claim 1, characterized in that: The plurality of electrodes include a head electrode and a plurality of ring electrodes. The head electrode is arranged at the head end of the distal end of the catheter body, and the plurality of ring electrodes are arranged in a spaced manner along the distal end of the catheter body.

10. An electrophysiological device, characterized in that: The invention comprises an electrophysiological system and an electrophysiological catheter as claimed in any one of claims 1 to 9, wherein the electrophysiological system is signal-connected to the electrophysiological catheter to acquire an electrical signal of a contact portion of the electrophysiological catheter.

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