An electrophysiological catheter and electrophysiological device

Abstract

This application discloses an electrophysiological catheter and an electrophysiological device, relating to the field of medical device technology. The electrophysiological catheter has multiple electrodes disposed at the distal end of its main body. A bending drive is embedded in the distal end of the catheter main body, and the bending drive is pre-shaped to have a predetermined bending shape, and is capable of elastic deformation. A bending mechanism is connected to the bending drive, and the bending mechanism applies force to the bending drive to prevent it from returning to the predetermined bending shape. When the bending mechanism reduces the force applied to the bending drive, the bending drive gradually and actively returns to the predetermined bending shape. The distal end of the catheter main body adaptively deforms according to the shape of the bending drive to adjust the distance and / or angle between the multiple electrodes. This electrophysiological catheter, utilizing a pre-shaped bending drive, effectively solves the problem of unstable bending shape in traditional electrophysiological catheters, improving the catheter's maneuverability and mapping accuracy.

Description

Technical Field

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

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

[0003] In practice, the inventors discovered the following defects in existing electrophysiological catheters:

[0004] Electrophysiological catheters are passively bent under the pull of a drawstring. This bending method results in unstable catheter shapes and necessitates additional structures to guide and support the drawstring, increasing the difficulty of catheter design and fabrication. Furthermore, current electrophysiological mapping procedures often require multiple replacements of different catheter models to meet the clinical needs of different sites, limiting their applicability. Summary of the Invention

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

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

[0007] Catheter body;

[0008] Multiple electrodes are disposed on the distal end of the catheter body;

[0009] A bending drive is embedded in the distal end of the conduit body. The bending drive is pre-shaped to have a set bending shape and is capable of elastic deformation.

[0010] A bending adjustment mechanism is connected to the bending adjustment drive component. The bending adjustment mechanism is used to apply force to the bending adjustment drive component to prevent the bending adjustment drive component from returning to the set bending shape.

[0011] 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 conduit body adapts to the shape of the bending adjustment drive to adjust the distance and / or angle between the multiple electrodes.

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

[0013] The distal end of the catheter body is made of a stretchable polymer material to follow the bending drive component in stretching and / or bending deformation.

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

[0015] When the bending drive is under tension, the main body of the guide tube is in a first state;

[0016] When no force is applied, the bending drive returns to the set bending shape, and the conduit body is in the second state;

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

[0018] In some embodiments, the bending drive component comprises bending segments having different preset bending patterns; or,

[0019] The number of the bending adjustment drive components is multiple, and the multiple bending adjustment drive components are distributed along the axial direction of the conduit body. The bending adjustment mechanism has traction components corresponding to the number of bending adjustment drive components. The bending adjustment drive components and the traction components are connected one-to-one. One or more of the traction components remove the force applied to the bending adjustment drive components so that the conduit body presents different overall bending shapes.

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

[0021] In some embodiments, the handle includes a push button, a push rod, a limiting groove, and a seat, and the traction member is a pull cable;

[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 extends and retracts relative to the conduit body as the push rod slides, thereby changing the force applied to the bending drive component.

[0025] In some embodiments, the limiting groove has a plurality of axially distributed locking positions, which engage with the push rod to prevent the bending drive from reverting to the set bending shape.

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

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

[0028] The sheath is disposed at the proximal end of the bending drive component, the sheath is sleeved over the traction component, and the sheath is capable of elastic deformation.

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

[0030] This application also provides an electrophysiological device, including an electrophysiological system and the aforementioned electrophysiological catheter, wherein the electrophysiological system is signal-connected to the electrophysiological catheter to obtain electrical signals at the contact portion of the electrophysiological catheter.

[0031] Compared to the aforementioned background technology, the electrophysiological catheter provided in this application mainly includes a catheter body, electrodes, a bending drive, and a bending mechanism; multiple electrodes are disposed on the distal end of the catheter body; the bending drive is embedded in the distal end of the catheter body, and the bending drive has a predetermined bending shape through pre-forming treatment, and the bending drive can undergo elastic deformation; the bending mechanism is connected to the bending drive, and the bending mechanism is used to apply force to the bending drive to prevent the bending drive from returning to the predetermined bending shape; when the bending mechanism reduces the force applied to the bending drive, the bending drive gradually and actively returns to the predetermined bending shape, and the distal end of the catheter body adaptively deforms according to the shape of the bending 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 bending shape is a key technical challenge, directly affecting the accuracy and safety of catheter manipulation within the heart. The electrophysiology catheter technology solution provided in this application effectively solves this problem through an innovative design of the bending drive and bending mechanism.

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

[0034] This design allows for more precise and flexible control of the catheter's bending shape, eliminating reliance solely on any drawstring or support structure. This simplifies the catheter's structure and improves its maneuverability and mapping accuracy. Through a pre-designed bending actuator, the catheter can actively return to a predetermined bending shape. This feature significantly enhances the stability and reliability of catheter navigation within the heart, enabling physicians to more accurately locate electrodes in complex cardiac anatomy for effective electrophysiological signal mapping and / or ablation. Furthermore, because the catheter actively adjusts its bending shape via the pre-designed bending actuator, it can present different bending shapes and adjust the electrode spacing, more flexibly and broadly meeting the catheter needs of the electrophysiology field, adapting to mapping and / or ablation purposes at multiple sites during operation.

[0035] Based on the above structural and process descriptions, it can be seen that the electrophysiological catheter has at least the following beneficial effects: The electrophysiological catheter utilizes a pre-designed bending drive, which effectively solves the problem of unstable bending shape of traditional electrophysiological catheters, improves the maneuverability and mapping accuracy of the catheter, and is suitable for mapping and / or ablation purposes at multiple sites. Attached Figure Description

[0036] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only embodiments of this application. For those skilled in the art, other drawings can be obtained based on the provided drawings without creative effort.

[0037] Figure 1 A schematic diagram showing that the electrophysiological catheter provided in this embodiment has not returned to the set bend shape;

[0038] Figure 2 A schematic diagram showing the electrophysiological catheter provided in this application returning to a predetermined curved shape;

[0039] Figure 3 A schematic diagram showing that the bending drive provided in this application embodiment has not returned to the set bending shape;

[0040] Figure 4 A schematic diagram illustrating the bending drive component provided in this application restoring to a set bending shape;

[0041] Figure 5 A schematic diagram showing that the catheter body has not returned to the set bending shape according to the embodiments of this application;

[0042] Figure 6 A schematic diagram showing the catheter body returning to a predetermined curved shape according to an embodiment of this application;

[0043] Figure 7 A schematic diagram (AA) of the catheter body provided in the embodiments of this application;

[0044] Figure 8 A schematic diagram of the catheter body provided in the embodiments of this application;

[0045] Figure 9 A schematic diagram of the bending mechanism provided in the embodiments of this application;

[0046] Figure 10 This is a first schematic diagram of the bending drive component provided in the embodiments of this application after assembly;

[0047] Figure 11 A second schematic diagram of the bending drive component provided in the embodiments of this application after assembly;

[0048] Figure 12 This is a third schematic diagram of the bending drive component provided in the embodiments of this application after assembly.

[0049] in:

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

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

[0052] Bending drive component 3, expansion joint 31, transition section 32, first bending drive component 301, second bending drive component 302.

[0053] The bending mechanism 4, handle 41, push button 411, push rod 412, limit groove 413, seat 414, fixed seat 415, and traction component 42. Detailed Implementation

[0054] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0055] To enable those skilled in the art to better understand the present application, the present application will be further described in detail below with reference to the accompanying drawings and specific embodiments. In the specific embodiments, the distal end refers to the portion of the corresponding component away from the operator, typically the end where the component enters the patient's body or surgical area. The proximal end is the portion of the corresponding component closer to the operator, typically the end held or manipulated by the operator. For a single component, the end closer to the operator is the proximal end, and the end further away from the operator is the distal end.

[0056] Please refer to Figure 1 and Figure 2 , Figure 1 This is a schematic diagram showing an electrophysiological catheter that has not returned to the intended curved shape, as provided in an embodiment of this application. Figure 2 This is a schematic diagram of the electrophysiological catheter provided in the embodiment of this application returning to the set curved shape.

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

[0058] Multiple electrodes 2 are disposed on the distal end of the catheter body 1; the bending drive 3 is embedded in the distal end of the catheter body 1, the bending drive 3 has a set bending shape through pre-forming treatment, and the bending drive 3 can undergo elastic deformation; the bending mechanism 4 is connected to the bending drive 3, and the bending mechanism 4 is used to apply force to the bending drive 3 to prevent the bending drive 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 returns to the set bending shape, and the distal end of the conduit body 1 adapts 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 explanation uses the mapping function of an electrophysiological catheter as an example. However, this application does not limit the application of electrophysiological catheters in the diagnosis and treatment of cardiac diseases such as arrhythmias. In the field of cardiac electrophysiology, by contacting electrodes with specific intracardiac tissues, such as the coronary sinus, His bundle, atrial wall, or ventricular wall, the electrocardiographic signals at that location are mapped, thereby enabling corresponding disease diagnosis. Conventional electrophysiological mapping catheters typically have 4 to 20 electrodes. The following illustration uses 4 mapping electrodes as an example, but this does not limit or exclude the number of electrodes in this application. Electrode 2 and the bending drive 3 are both located on the adjustable section at the distal end of the catheter.

[0061] In the design of traditional electrophysiology catheters, the stability of the catheter's bending shape is a key technical challenge, directly affecting the accuracy and safety of catheter manipulation within the heart. The electrophysiology catheter technology solution provided in this application effectively solves this problem through the innovative design of the bending drive component 3 and the bending mechanism 4.

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

[0063] This design allows for more precise and flexible control of the catheter's bending shape, eliminating reliance on any single drawstring or support structure. This simplifies the catheter's structure and improves its maneuverability and mapping accuracy. Through a pre-designed bending actuator 3, the catheter can actively return to a predetermined bending shape. This feature significantly enhances the stability and reliability of catheter navigation within the heart, enabling physicians to more accurately locate the electrode 2 within the complex cardiac anatomy for effective electrophysiological signal mapping and / or ablation. Furthermore, because the catheter actively adjusts its bending shape through the pre-designed bending actuator, it can present different bending shapes and adjust the electrode spacing, more flexibly and broadly meeting the catheter needs in the electrophysiological field, adapting to mapping and / or ablation purposes at multiple sites during operation.

[0064] Based on the above structural and process descriptions, it can be seen that the electrophysiological catheter has at least the following beneficial effects: The electrophysiological catheter utilizes a pre-designed bending drive 3, which effectively solves the problem of unstable bending shape of traditional electrophysiological catheters, improves the maneuverability and mapping accuracy of the catheter, and is suitable for mapping and / or ablation purposes at multiple sites.

[0065] It should be noted that the electrophysiological catheter provided in this embodiment adopts a novel bending adjustment mechanism, specifically a novel bending adjustment mechanism for electrophysiological catheters. This electrophysiological catheter achieves changes in bending shape through the bending adjustment drive 3 inside the catheter body 1, enabling diversified bending control and precise bending control.

[0066] In some cases, the bending drive 3 can be an elastic mechanism embedded inside the catheter body 1. The catheter body 1 is tightly connected to and synchronously changes with the elastic mechanism, which provides the driving force for the bending change of the catheter body 1. Although the bending mechanism 4 acts as an inhibitory control over the elastic mechanism, the driving source for the bending change of the electrophysiological catheter is actually the elastic mechanism. Through the pre-shaped treatment of the elastic mechanism, the elastic mechanism is shaped into an elongated state, a bent state, or a combination of both. Under the force applied by the bending mechanism 4, the elastic mechanism is compressed, deflected, or a combination of both, changing the force applied by the bending mechanism 4 so that the elastic mechanism can ultimately achieve the set bending state of the pre-shaped treatment.

[0067] The elastic mechanism can be a helical spring or a grooved tube. The helical spring is formed by winding round or flat wires, or by continuous cutting of the tube. The grooved tube is typically formed by discontinuous cutting of the tube. The pre-formed shape of the bending drive 3 can be as follows: Figure 1 , Figure 2 , Figure 3 or Figure 4 The shape and curvature of the distal end of any of the catheters shown in the figure are, as will be understood by those skilled in the art, not limited to the type shown in the figure, but adjusted according to actual needs, and all of them fall within the protection scope of this application.

[0068] Optionally, the elastic mechanism can be made of nickel-titanium alloy. By pre-shaping the elastic mechanism, its bending shape during expansion and contraction can be controlled to meet the bending requirements of the conduit. Specifically, during the pre-shaping process, the nickel-titanium alloy is wound into a filament structure onto a shaping mold with a predetermined bending shape, and then shaped into the set bending shape by heat treatment.

[0069] In some embodiments, baffles (not shown) are provided at both the distal and proximal ends of the elastic mechanism. The baffles are made of rigid material, such as metal structural components or adhesive fixing blocks with a certain strength. The bending mechanism 4 is connected to the baffles. The distal baffle provides space for the wire 23 to pass through, and the proximal baffle provides space for the wire 23 and the traction member 42 to pass through. The traction member 42 is connected to the distal baffle, and force is applied to the elastic mechanism through the traction member 42.

[0070] Please refer to Figure 3 and Figure 4 , Figure 3This is a schematic diagram showing the bending drive component provided in the embodiment of this application failing to return to the set bending shape. Figure 4 This is a schematic diagram of the bending drive component provided in the embodiment of this application restoring to the set bending shape.

[0071] In some embodiments, the bending drive 3 includes a plurality of telescopic joints 31 connected in sequence, and the bending drive 3 can be extended and / or bent by the deformation of the telescopic joints 31.

[0072] The distal end of the conduit body 1 is made of a stretchable polymer material to follow the bending drive 3 to stretch and / or bend.

[0073] In this embodiment, the bending drive 3 is a core component of the electrophysiological catheter, comprising multiple interconnected telescopic joints 31. These telescopic joints 31, through their own deformation capabilities, enable the bending drive 3 to extend and / or bend, thereby finely adjusting the curvature of the catheter body 1 to adapt to different surgical procedures and internal structures.

[0074] The distal end of the catheter body 1 is made of a stretchable polymer material, which allows the catheter body 1 to stretch and / or bend 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 ever-changing paths and target locations within the body while maintaining coordinated movement with the bending drive 3.

[0075] It should be understood that, compared to existing technologies that rely on a drawstring to bend the catheter, this method adjusts the catheter's shape by changing the length of the drawstring within the catheter, causing the distal end to bend and conform to the desired shape. In other words, the catheter's morphology depends on the length of the drawstring, meaning the catheter itself only bends and deforms without elongation or stretching. In existing technologies, the linear distance between electrodes is only affected by the bending angle; the axial distance between adjacent electrodes along the catheter's bending trajectory remains largely unchanged. Therefore, existing technologies do not consider the material of the distal end of the catheter. Consequently, while existing electrophysiological catheters have some bending capability, their applicability is limited, requiring operators to change catheters multiple times or combine multiple catheters to achieve clinical objectives. In contrast, this application uses the bending drive 3 as the power source to drive the catheter bending. The various types of bending drive structures listed above can bend and also expand and contract. That is, while the bending shape of the distal end of the catheter changes, the length of the adjustable bending section of the distal end of the catheter also changes. The straight distance between each electrode is not only affected by the bending angle, but the axial distance between adjacent electrodes also changes synchronously along the bending trajectory of the catheter. Based on this, the distal end of the catheter in this application is made of a polymer with good elasticity and compliance. Thus, this application can not only adjust the bending shape of the distal end of the catheter, but also adjust the length of the adjustable bending section of the distal end of the catheter, making the distribution of each electrode more flexible and catering to the clinical needs of the operator. When the bending actuator of this application returns to the set bending shape, the adjustable bending section of the catheter has the maximum length, which is suitable for entering deeper and more distant locations in the heart, such as inside the coronary sinus ostium. Thus, the catheter of this application can dynamically adjust the distribution of each electrode at the distal end of the catheter by reducing the inhibition of the bending actuator to different degrees, thereby enabling the bending actuator to actively bend into different bending shapes and extension lengths. This adapts to the guidance of multiple sites during mapping or ablation without the need for frequent catheter replacement, simplifying the operation steps and increasing the versatility of the catheter.

[0076] This design allows for more precise control of the catheter tip's position and orientation during electrophysiological signal mapping, improving surgical accuracy and safety. Simultaneously, the use of polymer materials ensures the catheter's biocompatibility within the body, reducing surgical risks.

[0077] In some cases, taking the bending drive 3 as an example of an elastic mechanism, the shape change of the bending drive 3 is actually produced by the superposition effect of the telescopic joints 31. Each telescopic joint 31 can extend, contract, and bend independently, but when they are connected in sequence to form the bending drive 3, their combined motion forms the overall shape change of the bending drive 3. This design enables the bending drive 3 to actively bend and / or extend in a precise and controllable manner in response to the force applied by the bending mechanism 4.

[0078] When the bending mechanism 4 applies force, the telescopic joints 31 compress or extend one by one. This continuous, 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 return to their initial state one by one, thereby restoring the bending drive 3 to the predetermined bending shape after pre-processing. This morphological change based on the superimposed changes of the telescopic joints 31 provides the electrophysiological catheter with high flexibility and precise control, enabling accurate positioning and mapping during surgery.

[0079] Please refer to Figure 5 and Figure 6 , Figure 5 This is a schematic diagram showing the catheter body not returning to the intended bent shape, as provided in an embodiment of this application. Figure 6 A schematic diagram of the catheter body restoring to a set curved shape according to an embodiment of this application (some electrodes are omitted).

[0080] In some embodiments, the force exerted by the bending mechanism 4 on the bending drive 3 is a tension force;

[0081] When the bending drive component 3 is under tension, the guide tube body 1 is in the first state;

[0082] When the bending drive 3 is not under any applied force, the bending drive 3 returns to the set bending shape, and the guide body 1 is in the second state;

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

[0084] In this embodiment, the bending mechanism 4 controls the state of the bending drive 3 by applying tension, thereby affecting the shape of the catheter body 1. When the bending mechanism 4 applies tension to the bending drive 3, the bending drive 3 is in a tensile state, causing the catheter body 1 to change to the first state. In this state, the curvature of the catheter body 1 is reduced and the length is shortened. This bending shape facilitates the catheter to pass through the sheath or the tortuous tissues of the human body and reach the target site more smoothly.

[0085] Conversely, when the bending mechanism 4 does not apply force to the bending drive 3, the bending drive 3 is not under force and will return to the predetermined bending shape according to the elastic properties of its material. At this time, the conduit body 1 changes to the second state. In the second state, the curvature of the conduit body 1 increases and its length increases. This design allows the conduit body 1 to adapt to a wider operating space or enter more complex target positions, providing better positioning and greater flexibility and adaptability.

[0086] This design allows the electrophysiological catheter to flexibly switch between two states by adjusting the tension applied by the bending mechanism 4, according to different needs during the procedure, to achieve optimal operational results and the highest level of surgical safety. This design not only improves the catheter's maneuverability but also allows it to better adapt to complex intraoperative pathways, providing a more precise and controllable tool for electrophysiological mapping.

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

[0088] Optionally, the adjustable bending segment 11 has a first state and a second state, wherein the arc of the adjustable bending segment 11 in the first state is smaller than that in the second state, and the length in the first state is shorter than that in the second state.

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

[0090] In one specific implementation, different implementation methods can be used to achieve a wider variety of bending shapes for the bending drive component 3.

[0091] In some embodiments, the bending drive 3 is composed of bending segments having different set bending patterns.

[0092] In this embodiment, the bending drive 3 is composed of multiple bending segments with different preset bending shapes. In this way, each bending segment can independently contribute to the overall bending shape of the catheter body 1, thereby enabling the catheter body 1 to achieve diverse bending forms. This design improves the flexibility and adaptability of the catheter, allowing it to better adapt to complex internal structures and surgical pathways.

[0093] In some embodiments, there are multiple bending drive members 3, which are distributed along the axial direction of the conduit body 1. The bending mechanism 4 has a traction member 42 corresponding to the number of bending drive members 3. The bending drive members 3 and the traction members 42 are connected in a one-to-one correspondence. One or more traction members 42 remove the force applied to the bending drive members 3 so that the conduit body 1 presents different overall bending shapes.

[0094] In this embodiment, this method uses a combination of multiple bending drive components 3 to achieve diversified bending adjustments of the conduit body 1 by using multiple bending drive components 3.

[0095] The bending drive components 3 are distributed along the axial direction of the conduit body 1, meaning they are arranged sequentially along the axial direction of the conduit, providing multiple bending adjustment areas for the conduit. The bending mechanism 4 is equipped with a number of traction components 42 equal to the number of bending drive components 3, ensuring that each bending drive component 3 can be connected to a traction component 42 in a one-to-one correspondence. This one-to-one correspondence allows for individual control of each bending drive component 3. By operating the traction component 42, force can be applied to or removed from a specific bending drive component 3.

[0096] When one or more traction elements 42 remove the force applied to the bending drive element 3, the corresponding bending drive element 3 will return to its preset bending shape according to the elasticity of its material. This change causes the catheter body 1 to exhibit different overall bending shapes, 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 pathways according to the specific needs of the surgical procedure. In this way, the electrophysiological catheter can reach the target location more accurately, improving the efficiency and safety of the surgery.

[0097] Please refer to Figures 10 to 12 ,in, Figure 10 This is a first schematic diagram of the bending drive component provided in the embodiments of this application after assembly. Figure 11 This is a second schematic diagram of the bending drive component provided in the embodiments of this application after assembly. Figure 12 This is a third schematic diagram of the bending drive component provided in the embodiments of this application after assembly.

[0098] In some cases, a transition section 32 is provided between multiple bending drive components 3 to connect adjacent bending drive components 3. The bending drive component 3 located at the far end of the transition section 32 will rely on the transition section 32 to generate bending shape changes. Generally, the ratio of pitch to line width of the transition section 32 is 1:1 to 2:1, while the ratio of pitch to line width of the bending drive component 3 is greater than 2:1. The transition section 32 is less sensitive to changes in the force applied by the bending mechanism 4 compared to the bending drive component 3.

[0099] by Figures 10 to 12 For example, there are two bending drive components 3, including a first bending drive component 301 and a second bending drive component 302. The first bending drive component 301 and the second bending drive component 302 are connected by a transition section 32. The first bending drive component 301 is located at the far end, and the second bending drive component 302 is located at the near end.

[0100] exist Figure 10 In the middle, the first bending drive 301 at the far end returns to the set bending shape, while the second bending drive 302 at the near end does not return to the set bending shape and is still in a compressed state. At this time, the first bending drive 301 and the second bending drive 302 form the first bending shape.

[0101] exist Figure 11 In the middle, the second bending drive 302 at the near end returns to the set bending shape, while the first bending drive 301 at the far end does not return to the set bending shape and is still in a compressed state. At this time, the first bending drive 301 and the second bending drive 302 form a second bending shape.

[0102] exist Figure 12 In the middle, the first bending drive 301 at the far end and the second bending drive 302 at the near end both return to the set bending state. At this time, the first bending drive 301 and the second bending drive 302 form a third bending state.

[0103] It should be noted that the above description and figures show the state and bending shape when any bending drive is fully restored to the set bending shape. In actual use, the intermediate state when any bending drive is not fully restored to the set bending shape also causes the distal end of the catheter to present different bending and stretching states. These intermediate states are also the result of the control of the distal end of the catheter in this application, so that the catheter of the application has diverse bending states and high flexibility. Thus, the catheter can adjust its shape to adapt to different operating environments and paths according to the specific needs of the operation.

[0104] By setting multiple bending drive components 3 in the adjustable bending section 11 and adjusting parameters such as the material, length, cross-sectional size, or pitch of the bending drive components 3, a special deformation sequence of the bending drive components 3 during bending can be designed, allowing for more flexible adjustment of the bending control shape and meeting more requirements for the positioning of the conduit.

[0105] Please refer to Figure 9 , Figure 9 This is a schematic diagram of the bending mechanism provided in an embodiment of this application.

[0106] In some embodiments, the bending mechanism 4 includes a handle 41 and a traction member 42. The handle 41 is connected to the proximal end of the catheter body 1, and the proximal end of the traction member 42 is connected to the handle 41. 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. Since the bending drive member 3 is nested within the catheter body 1, the distal end of the traction member 42 enters the inner cavity of the bending drive member 3 and connects to it, allowing the traction member 42 to extend and retract relative to 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 for easy gripping and operation by the operator. The proximal end of the traction member 42 is connected to the handle 41, while its distal end extends into the interior of the catheter body 1 and is connected to the bending drive member 3.

[0108] The force applied to the bending drive 3 by the traction member 42 can be controlled by operating the handle 41. This design allows the operator to precisely adjust the shape of the bending drive 3 via the external handle 41, thereby changing the bending shape of the catheter body 1. This mechanism enables the electrophysiological catheter to flexibly adjust its shape according to the needs of the surgical procedure, adapting to different operating environments and pathways.

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

[0110] The proximal end of the catheter body 1 is fixedly connected to the seat 414, and neither the proximal end of the catheter body nor the seat moves during the application of force by the handle to the bending drive 3.

[0111] Push button 411 is connected to push rod 412, push rod 412 is connected to pull wire, push rod 412 extends into limit groove 413 and slides in limit groove 413;

[0112] The pull wire slides with the push rod 412 and extends or retracts relative to the guide tube body 1 to change the force applied to the bending drive 3.

[0113] In this embodiment, the handle 41 is an important component of the bending mechanism 4, and it consists of several key components: push button 411, push rod 412, limiting groove 413, and seat 414. These components work together to enable the operator to precisely control the traction member 42, i.e., the pull line, thereby changing the force applied to the bending drive member 3.

[0114] The proximal end of the catheter body 1 is fixedly connected to the seat 414, ensuring stability and operational accuracy between the handle 41 and the catheter body 1. The push button 411 is connected to the push rod 412, allowing the operator to control the movement of the push rod 412 via the push button 411. The push rod 412 is connected to the pull cable, so its movement can be directly transmitted to the pull cable, enabling control of the pull cable.

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

[0116] Specifically, the traction component 42, i.e. the pull cable, is connected to the far end of the bending drive component 3.

[0117] In some cases, the bending mechanism 4 also includes a fixed seat 415, which is connected to the push rod 412. 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 tensioned or relaxed as the push button 411 and the push rod 412 move, thereby controlling the extension and retraction of the bending drive member 3. At the same time, since the proximal end of the conduit body 1 is fixed to the seat 414, the proximal end of the conduit body 1 will not move when the push button 411 and the push rod 412 are pushed. When the bending drive member 3 extends and retracts, since the conduit body 1 is made of a stretchable polymer material, it will follow the extension and retraction of the bending drive member 3 to achieve the bending shape change.

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

[0119] In some embodiments, the limiting groove 413 has a plurality of axially distributed locking positions, which engage with the push rod 412 to prevent the bending drive 3 from returning to the set bending shape and remaining in the current state. The current state can be any corresponding intermediate state before the bending drive 3 returns to the set bending shape.

[0120] In this embodiment, the limiting groove 413 includes multiple axially distributed locking positions, which provide different fixed positions for the push rod 412 under static conditions. Each locking position can engage with the push rod 412, generating sufficient friction to resist the restoring pull of the bending drive 3. This design ensures that when not in operation, the bending drive 3 can maintain its current bending state and will not return to its preset bending state due to the elasticity of the bending drive 3 itself.

[0121] When the operator needs to adjust the curvature of the catheter body 1, an appropriate pushing force is applied to the push button 411. This pushing force is sufficient to overcome the friction provided by the locking groove 413, thereby driving the push rod 412 to slide along the locking groove 413. The sliding of the push rod 412 is transmitted to the traction member 42, i.e., the pull wire, which in turn changes the force applied to the bending drive member 3, thereby achieving the adjustment of the curvature of the catheter body 1.

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

[0123] exist Figure 7In this structure, the adjustable bending section 11 has a single-cavity structure, and a bending drive 3 is installed inside the adjustable bending section 11. There is a very small gap or an interference fit between the adjustable bending section 11 and the bending drive 3. Sufficient space is reserved inside the bending drive 3 to allow the passage of the wire 23 and the traction member 42. The wire 23 is electrically connected to the electrode 2.

[0124] In some embodiments, such as Figure 8 The main body section 12 is a multi-cavity tube structure, which should ensure sufficient support and rigidity when the adjustable bending section 11 is bent. Higher rigidity materials or an embedded metal braided layer can be selected. The multiple cavities of the main body section 12 are respectively connected to the conductor 23 and the traction member 42. Specifically, taking an example with two traction members 42, the main body section 12 has a three-cavity tube structure. The middle cavity is the conductor cavity connected to the conductor 23, and the two outer cavities are the pull-line cavities connected to the traction members 42, i.e., the pull-line cavities. The two pull-line cavities are symmetrically arranged with the conductor cavity as the center.

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

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

[0127] The sheath is located near the bending drive 3 and is fitted over the traction member 42 of the main body section 12. The sheath is capable of elastic deformation.

[0128] In this embodiment, the bending mechanism 4 includes not only the traction member 42 but also a sheath component. The traction member 42 is directly connected to the bending drive member 3, responsible for transmitting the force required for bending, while the sheath is located at the proximal end of the bending drive member 3. Correspondingly, the bending drive member 3 is nested within the adjustable bending section 11 at the distal end of the conduit, and the main body section 12 is connected to the proximal end of the adjustable bending section 11. The sheath is located within the main body 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 line, to ensure the alignment of the pull line and prevent the conduit from bending.

[0129] The function of the sheath is to provide additional protection and support for the traction component 42. It can be selected as a helical spring tube, a polymer sheath, or a combination of both. The helical spring tube provides a certain degree of elasticity and support, while the polymer sheath increases wear resistance and protection. This design allows the sheath not only to withstand a certain mechanical load, but also to accommodate the elastic deformation of the traction component 42 during bending.

[0130] The sheath's elastic deformation capability means it remains stable when the traction element 42 is stretched or compressed, reducing frictional damage to the catheter body 1 and protecting the traction element 42 from potential external environmental influences. This design improves the durability and reliability of the bending mechanism 4, while also ensuring the stability and precision of the electrophysiological catheter during operation. In this way, the sheath helps maintain the overall performance of the catheter, extends its service life, and ensures the safety and effectiveness of the procedure.

[0131] Please continue to refer to this. 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 disposed separately along the distal end of the catheter body 1.

[0132] In this embodiment, the electrode system of the electrophysiological catheter consists of a head electrode 21 and multiple ring electrodes 22, which together constitute multiple electrodes 2. These electrodes are all disposed on the adjustable bend of the catheter. The head electrode 21 is located at the distal end of the catheter body 1, while the ring electrodes 22 are spaced apart along the distal end of the catheter body 1. This arrangement allows the catheter to map electrophysiological signals at different locations.

[0133] Furthermore, the lead wire 23 is electrically connected to these multiple electrodes 2, responsible for transmitting the electrophysiological signals detected by the electrodes to the electrophysiological device. The lead wire 23 passes through the inside of the catheter body 1, particularly 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 its bending shape is adjusted, the lead wire 23 will not interfere with the bending drive 3, 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, and the spacing between the first ring electrode 221, the second ring electrode 222, and the third ring electrode 223 varies according to the shape of the bend. Besides this, the ring electrode 22 can also be of other quantities, which will not be elaborated here.

[0135] In some embodiments, the bending drive is nested within the adjustable bend at the distal end of the conduit body. The adjustable bend can be shaped as a C, L, J, P, or S form under the drive of the bending drive. It should be noted that the bend shape can be a single bending drive 3 with pre-defined bends (C, L, J, P, and S), or it can be a combination of multiple bending drive 3s combined and presented as a whole when the bending mechanism 4 is released from force, or the shape of the adjustable bend in any intermediate state. These will not be listed individually here. It should be noted that the aforementioned bend shape refers to the shape of the adjustable bend resembling the aforementioned letter shape. This does not contradict the existing technology's designation of different conduit models based on adjustable bend length, adjustable bend radius, and bend type. For example, existing conduits designated A, B, C, D, E, F, K, and J are designations for specific adjustable bend lengths, adjustable bend radii, and bend types, used for differentiation. Those skilled in the art should understand that the conduit of this application presents different shapes and dynamically changes with set bending forms and intermediate states. Due to the structural and material characteristics of the solution of this application, it can present different bending shapes and different extension lengths. This allows for switching from one type of conduit in the prior art to another type of conduit, reducing the number of times the prior art needs to switch between different types of conduits due to the need to change shapes and lengths, making it more convenient and easier to operate.

[0136] In this embodiment, the design of the bending drive 3 allows it to obtain specific bending profiles through a pre-forming process, including C-shaped, L-shaped, J-shaped, P-shaped, and S-shaped profiles. The pre-forming process is a step in the manufacturing process that enables the bending drive 3 to be molded into specific shapes as needed and to retain these shapes after the molding force is removed.

[0137] This processing method gives the bending drive 3 the ability to automatically return 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 3, the bending drive 3 can return from the compressed or stretched state to its pre-shaped C, L, J, P and S shapes, with a deflection angle of 0° to 270°.

[0138] In one specific implementation, the process of using the electrophysiological catheter is described below.

[0139] When the bending drive 3 is in the extended state, it drives the adjustable bending section 11 of the conduit body 1 to extend, so that the adjustable bending section 11 exhibits a larger bending shape. At the same time, the spacing of the ring electrodes 22 also increases, so as to realize the real-time adjustment of the bipolar measurement position and range.

[0140] In the initial state of the catheter body 1, the push button 411 and push rod 412 of the bending mechanism 4 are in the 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 causes the bending drive member 3 connected to it to contract, causing the adjustable bending section 11 tube body fixedly connected to the bending drive member 3 to contract. At this time, the adjustable bending section 11 of the catheter is in the minimum bending state, which facilitates the catheter body 1 to pass through the sheath and enter the sheath more smoothly.

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

[0142] This application also provides an electrophysiological device, including an electrophysiological system and the aforementioned electrophysiological catheter, wherein the electrophysiological system is signal-connected to the electrophysiological catheter to obtain electrical signals from the contact portion of the electrophysiological catheter.

[0143] The electrophysiological device should have all the beneficial technical effects of the aforementioned electrophysiological catheters, which will not be elaborated here.

[0144] In this embodiment, the electrophysiological system is electrically connected to the lead wire 23 of the electrophysiological catheter, enabling the electrophysiological system to acquire electrical signals from the contact portion of the electrophysiological catheter. This design of the electrophysiological device ensures effective acquisition and transmission of electrophysiological signals, enabling real-time monitoring and analysis of cardiac electrophysiological activity.

[0145] It should be noted that many of the components mentioned in this application are general standard parts or components known to those skilled in the art, and their structure and principle 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 used only to distinguish one entity from several other entities, and do not necessarily require or imply any such actual relationship or order between these entities.

[0147] The electrophysiological catheters and electrophysiological devices provided in this application have been described in detail above. Specific examples have been used to illustrate the principles and implementation methods of this application. The descriptions of the embodiments above are only for the purpose of helping to understand the methods and core ideas of this application. It should be noted that those skilled in the art can make several improvements and modifications to this application without departing from the principles of this application, and these improvements and modifications also fall within the protection scope of the claims of this application.

Claims

1. An electrophysiological catheter, characterized in that, include: Catheter body; Multiple electrodes are disposed on the distal end of the catheter body; A bending drive is embedded in the distal end of the conduit body. The bending drive is pre-shaped to have a set bending shape and is capable of elastic deformation. A bending adjustment mechanism is connected to the bending adjustment drive component. The bending adjustment mechanism is used to apply force to the bending adjustment drive component to prevent the bending adjustment drive component 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 conduit body adapts to the shape of the bending adjustment drive to adjust the distance and angle between the multiple electrodes. The bending drive component includes multiple telescopic joints connected in sequence, and the bending drive component can be extended and / or bent by the deformation of the telescopic joints. The distal end of the catheter body is made of a stretchable polymer material to follow the bending drive component in stretching and / or bending deformation.

2. The electrophysiological catheter according to claim 1, characterized in that, The force exerted by the bending adjustment mechanism on the bending adjustment drive component is a tensile force; When the bending drive is under tension, the main body of the guide tube is in a first state; When no force is applied, the bending drive returns to the set bending shape, and the conduit body is in the second state; The curvature of the catheter body in the first state is smaller than that in the second state, and the length of the catheter body in the first state is shorter than that in the second state.

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

4. The electrophysiological catheter according to claim 3, characterized in that, The handle includes a push button, a push rod, a limiting groove, and a seat; the traction component is a pull cable. 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 extends and retracts relative to the conduit body as the push rod slides, thereby changing the force applied to the bending drive component.

5. The electrophysiological catheter according to claim 4, characterized in that, The limiting groove has multiple axially distributed locking positions, which engage with the push rod to prevent the bending drive from reverting to the set bending shape.

6. The electrophysiological catheter according to claim 1, characterized in that, The bending mechanism includes a traction component and a protective sleeve; The traction component is connected to the bending drive component; The sheath is disposed at the proximal end of the bending drive component, the sheath is sleeved over the traction component, and the sheath is capable of elastic deformation.

7. The electrophysiological catheter according to claim 1, characterized in that, The plurality of electrodes includes a head electrode and a plurality of ring electrodes. The head electrode is disposed at the distal end of the catheter body, and the plurality of ring electrodes are spaced apart along the distal end of the catheter body.

8. An electrophysiological device, characterized in that, It includes an electrophysiological system and an electrophysiological catheter as described in any one of claims 1 to 7, wherein the electrophysiological system is signal-connected to the electrophysiological catheter to obtain electrical signals at the contact portion of the electrophysiological catheter.

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