Electrophysiology catheter and electrode assembly for an electrophysiology catheter

Abstract

The application relates to the field of electrophysiological catheters, and provides an electrophysiological catheter and an electrode assembly of the electrophysiological catheter. The electrode assembly of the electrophysiological catheter comprises a spline and a spline connecting seat, the spline is arranged on the distal end side of the spline connecting seat, the spline connecting seat comprises a first seat body and a second seat body, the second seat body is embedded in the first seat body, the distal end of the second seat body is exposed to the distal end of the first seat body, and the second seat body is rotatably arranged on the first seat body; a first sensor is arranged on the first seat body, the first sensor is non-coaxial with the second seat body, and the detectable signal of the first sensor comprises the spatial position of the first sensor relative to the rotation axis of the second seat body; and a second sensor is arranged on the second seat body, the second sensor is coaxially arranged with the second seat body, and the detectable signal of the second sensor comprises the rotation angle of the second seat body. The application mainly solves the problem of how to obtain the driving angle of a driving rod of an electrophysiological catheter.

Description

Technical Field

[0001] This application relates to the field of electrophysiological catheters. Background Technology

[0002] Atrial fibrillation (AF) is the most common arrhythmia in clinical practice, and its incidence gradually increases with age. Currently, catheter ablation has become an important treatment for AF. Pulsed electric field ablation is a novel tissue ablation technique based on physical energy factors that has emerged in recent years. It mainly utilizes the principle of irreversible electroporation, applying a high-voltage pulsed electric field to cells to cause irreversible perforation of the cell membrane, leading to gradual cell necrosis and ultimately achieving tissue ablation.

[0003] Currently, most pulse ablation devices on the market use petal-shaped or basket-shaped electrophysiological catheters, meaning the electrode assembly is a petal-shaped or basket-shaped catheter. By pushing and pulling the drive rod inside the tube, the distal end of the electrode assembly can be moved closer to or further away from the proximal end, thus retracting and expanding. When retracted, it is roughly cylindrical to facilitate entry and exit from the sheath; when expanded, it is petal-shaped or basket-shaped for ablation or mapping.

[0004] However, some designs require the rotation of a drive rod to adjust the shape of the electrode assembly, which necessitates obtaining the rotation angle of the drive rod in order to control the shape of the electrode assembly. Summary of the Invention

[0005] This application primarily addresses the problem of how to obtain the driving angle of the driving rod in an electrophysiological catheter.

[0006] In one aspect, an electrode assembly for an electrophysiological catheter is provided.

[0007] The electrode assembly of the electrophysiology catheter includes:

[0008] Splines, wherein electrodes are provided for transmitting electrical energy;

[0009] And a spline connector, wherein the spline is disposed on the distal end of the spline connector, the spline connector includes a first body and a second body, the second body is embedded in the first body, the distal end of the second body is exposed to the distal end of the first body, and the second body is rotatably disposed on the first body;

[0010] A first sensor is mounted on the first base. The first sensor is not coaxial with the second base. The detectable signal of the first sensor includes the spatial position of the first sensor relative to the rotation axis of the second base.

[0011] The second sensor is mounted on the second base and is coaxially arranged with the second base. The detectable signal of the second sensor includes the rotation angle of the second base.

[0012] In one embodiment, the first sensor and the second sensor are columnar structures, and the axes of the first sensor and the second sensor are both parallel to the rotation axis of the second base.

[0013] In one embodiment, the first sensor is at least a 5-DOF magnetic sensing coil, capable of detecting signals including coordinates along its own axis, two-dimensional coordinates perpendicular to its own axis, and rotations about each axis of the two-dimensional coordinate system; and / or, the second sensor is at least a 6-DOF magnetic sensing coil, capable of detecting signals including coordinates along its own axis, two-dimensional coordinates perpendicular to its own axis, rotations about its own axis, and rotations about each axis of the two-dimensional coordinate system.

[0014] In one embodiment, the projection is made along a direction parallel to the rotation axis of the second seat, and the projection of the first seat and the first sensor at least partially overlap.

[0015] In one embodiment, a receiving space is provided on the side wall of the first base, and at least a portion of the first sensor is disposed in the receiving space.

[0016] In one embodiment, the first seat is a tube, and the side wall of the tube is provided with a groove, which forms the receiving space.

[0017] In one embodiment, the electrode assembly includes a protective tube that is fixedly fitted over the outside of the first base, with the first sensor completely located inside the protective tube.

[0018] In one embodiment, the second seat is a tube, the second sensor is disposed in the inner cavity of the second seat, and at least a portion of the first sensor is located radially outside the second sensor.

[0019] In one embodiment, the spline is elastically deformable, the spline is a linear structure, and the spline has a first end and a second end;

[0020] The first seat is fixedly connected to the first end of the spline, the second seat is fixedly connected to the second end of the spline, and the side of the spline away from the spline connecting seat has a reverse fold portion;

[0021] When the first seat rotates relative to the second seat, the electrode assembly has an unfolded state and a retracted state; in the unfolded state, each spline forms a petal shape on the radially outer side of the spline connector; in the retracted state, the first end and the second end of any spline are offset along the circumference of the electrode assembly, and the spline has a retracted amount that bends toward the distal end of the electrode assembly compared to the unfolded state.

[0022] Secondly, an electrophysiological catheter is provided.

[0023] An electrophysiological catheter includes an operating handle, a tube body, and an electrode assembly connected sequentially from proximal to distal end, wherein the electrode assembly is any of the electrode assemblies described above, and the first seat of the electrode assembly is fixed to the tube body.

[0024] It also includes a drive rod, the distal end of which is connected to the second base to drive the second base to rotate. The operating handle includes a drive module, the proximal end of which is connected to the drive module, and the drive module is used to drive the drive rod to rotate.

[0025] The beneficial effects of this application are:

[0026] According to the electrode assembly in this application embodiment, the first sensor disposed on the first base is not coaxial with the second base. When the entire electrode assembly rotates around the axis of the second base, the detectable signal of the first sensor includes the spatial position of the first sensor relative to the rotation axis of the second base. At the same time, the second sensor disposed on the second base is coaxial with the second base, and the detectable signal of the second sensor includes the rotation angle of the second base, that is, the rotation angle around the rotation axis of the second base. Compared with obtaining the rotation angle of the second base by the sensor alone, the first sensor and the second sensor using the above arrangement can cooperate with each other to provide the necessary parameters for determining the overall rotation angle of the spline connector and the relative rotation angle between the first base and the second base, thereby creating conditions for obtaining the driving angle of the drive rod relative to the first base, so as to determine the shape of the electrode assembly. Attached Figure Description

[0027] Figure 1 This is a schematic diagram of the structure of one embodiment of the electrophysiology catheter in this application;

[0028] Figure 2 It is located in Figure 1 A three-dimensional view of the mid-to-rear electrode assembly in its deployed state;

[0029] Figure 3 yes Figure 2 Orthographic view;

[0030] Figure 4 yes Figure 3 Top view;

[0031] Figure 5 yes Figure 4 A schematic diagram of the first and second elastic skeletons of one of the splines;

[0032] Figure 6 yes Figure 3 A schematic diagram of the electrode assembly without connecting pipes and electrodes;

[0033] Figure 7 yes Figure 3 A three-dimensional view of the first base body and the first elastic skeleton connected to the first base body;

[0034] Figure 8 This is a schematic diagram of a usage scenario corresponding to an embodiment of an electrophysiological catheter in its deployed state;

[0035] Figure 9 yes Figure 8 A schematic diagram of the shape of the middle electrode assembly;

[0036] Figure 10 This is a schematic diagram of another usage scenario corresponding to one embodiment of the electrophysiology catheter in the deployed state;

[0037] Figure 11 yes Figure 10 Orthographic projection view of the middle electrode assembly;

[0038] Figure 12 This is a schematic diagram illustrating a usage scenario corresponding to an embodiment of an electrophysiological catheter in an incompletely retracted state;

[0039] Figure 13 yes Figure 12 Orthographic projection view of the middle electrode assembly;

[0040] Figure 14 yes Figure 13 Top view;

[0041] Figure 15 This is a schematic diagram of a usage scenario corresponding to an embodiment of an electrophysiological catheter in its fully retracted state;

[0042] Figure 16 This is a schematic diagram illustrating another usage scenario corresponding to an embodiment of the electrophysiology catheter in its fully retracted state;

[0043] Figure 17 yes Figure 15 and Figure 16 A three-dimensional schematic diagram of the middle electrode assembly;

[0044] Figure 18 yes Figure 17 Orthographic view;

[0045] Figure 19 yes Figure 18 Top view;

[0046] Figure 20 This is a sectional view of the distal portion of an embodiment of an electrophysiological catheter, with the cutting plane passing through the axis of the electrophysiological catheter and the center of the first end of the corresponding spline;

[0047] Figure 21 This is a sectional view of the distal portion of an embodiment of an electrophysiological catheter, with the cutting plane passing through the axis of the electrophysiological catheter and the center of the second end of the corresponding spline;

[0048] Figure 22 yes Figure 21 A magnified view of a specific part;

[0049] Figure 23 yes Figure 22 A schematic diagram of the fluid channels in the image;

[0050] Figure 24 This is a schematic diagram showing the connection between the infusion tubing and the supply tubing in one embodiment of an electrophysiology catheter;

[0051] Figure 25 yes Figure 24 A three-dimensional view of a local part.

[0052] List of feature names corresponding to the labels in the figure:

[0053] 100. Operating handle;

[0054] 200. Pipe body;

[0055] 210. Outer tube body; 211. Outer bending section; 2111. Outer tube body; 2112. Inner tube body; 2113. Braided layer; 212. Outer main body section;

[0056] 220. Inner tube body; 221. Inner bending section; 2211. Tube core; 2212. Flexible sealing tube; 222. Inner main body section;

[0057] 230. Injection pipe; 231. Adapter sleeve;

[0058] 240. Liquid supply pipe;

[0059] 250. Fluid channel;

[0060] 300. Electrode assembly;

[0061] 310. Spline; 311. First end; 312. Second end; 313. Fold-back section;

[0062] 321. Part One; 322. Part Two; 323. Middle Part;

[0063] 330. Spline connector; 331. First seat body; 3311. Slot; 332. Second seat body;

[0064] 340. Protective pipe;

[0065] 351. First elastic frame; 352. Second elastic frame; 353. Connecting pipe;

[0066] 361. First electrode; 362. Second electrode; 363. Intermediate electrode;

[0067] 371. First sensor; 372. Second sensor;

[0068] 400. Drive lever;

[0069] 500. Target organization. Detailed Implementation

[0070] The present application will now be described in further detail with reference to the accompanying drawings and specific embodiments. Similar elements in different embodiments are referred to by related similar element reference numerals. In the following embodiments, many details are described to facilitate a better understanding of the present application. However, those skilled in the art will readily recognize that some features may be omitted in different situations, or may be replaced by other elements, materials, or methods. In some cases, certain operations related to the present application are not shown or described in the specification. This is to avoid obscuring the core parts of the present application with excessive description. For those skilled in the art, detailed description of these related operations is not necessary; they can fully understand the related operations based on the description in the specification and general technical knowledge in the art.

[0071] Furthermore, the features, operations, or characteristics described in the specification can be combined in any suitable manner to form various embodiments. At the same time, the steps or actions in the method description can be rearranged or adjusted in a manner obvious to those skilled in the art. Therefore, the various orders in the specification and drawings are only for the clear description of a particular embodiment and do not imply a necessary order, unless otherwise stated that a particular order must be followed.

[0072] The serial numbers assigned to components in this document, such as "first" and "second," are used only to distinguish the described objects and have no sequential or technical meaning. The terms "connection" and "linkage" used in this application, unless otherwise specified, include both direct and indirect connections (linkages).

[0073] In the embodiments of this application, the electrode assembly is provided with a first sensor on the first base and a second sensor on the second base. The first sensor and the rotation axis of the second base are spaced apart, and the second sensor is arranged coaxially with the second base. When the second base is rotated, the signals collected by the first and second sensors can not only provide the required parameters for obtaining the overall rotation position of the electrode assembly, but also provide the required parameters for obtaining the rotation position of the second base relative to the first base, which facilitates obtaining the driving angle of the drive rod.

[0074] Those skilled in the art should understand that the terms "proximal" and "distal" used in this article are conventional medical terms. For the instrument to be operated on, the proximal end is the end closer to the operator, and the distal end is the end furthest from the operator. The distal end is usually the end that enters the patient's body first. For further information on proximal and distal ends, please refer to [reference needed]. Figure 1 The orientation shown in the diagram. Accordingly, the axial direction of the electrode assembly is the distribution direction of the proximal and distal ends, the radial direction is any direction perpendicular to the axial direction, and the circumferential direction is the direction in which the corresponding component surrounds the axis corresponding to the proximal and distal directions.

[0075] Examples of electrophysiological catheters in this application:

[0076] Please refer to Figure 1 In some embodiments, the electrophysiological catheter includes an operating handle 100, a tube body 200, and an electrode assembly 300, which are connected sequentially from the proximal end to the distal end of the electrophysiological catheter.

[0077] Among them, such as Figure 1 , Figure 24 The tube body 200 includes an outer tube body 210 and an inner tube body 220 nested within the outer tube body 210. The inner tube body 220 is used to transmit torque to the electrode assembly 300, forming a drive rod 400 (e.g., Figure 20 The pipe body 200 includes a bending section located at the distal end. Correspondingly, the outer pipe body 210 and the inner pipe body 220 respectively include an outer bending section 211 and an inner bending section 221 located at the distal end. The outer pipe body 210 and the inner pipe body 220 also include an outer main body section 212 and an inner main body section 222 respectively. The outer main body section 212 is connected to the proximal end of the outer bending section 211, and the inner main body section 222 is connected to the proximal end of the inner bending section 221.

[0078] The operating handle 100 allows the operator to grip and perform corresponding operations. Its specific operating functions can be designed as needed, such as adjusting the distal end of the tube body 200 and controlling the shape of the electrode assembly 300. The tube body 200 is connected to the distal end of the operating handle 100, enabling the electrode assembly 300 to move, and providing a substrate for the corresponding circuits, liquid circuits, and / or gas circuits, allowing these circuits, liquid circuits, and / or gas circuits to connect to the electrode assembly 300 via the operating handle 100. The electrode assembly 300 includes an elastically deformable spline 310, on which electrodes for transmitting electrical energy are distributed. By changing the shape of the spline 310, the distribution of the electrodes can be changed to meet different usage requirements.

[0079] It should be noted that the electrophysiological catheter in the embodiments of this application can be an ablation catheter used to ablate the target tissue 500, such as pulsed electric field ablation, radiofrequency ablation, etc.; in addition, in some other embodiments, the electrophysiological catheter in the embodiments of this application can be a mapping catheter used to collect electrophysiological signals of the target tissue 500.

[0080] To achieve morphological variations in the electrode assembly 300, in one embodiment of the electrophysiological catheter, the spline 310 is a linear structure with a folded portion 313, and the spline 310 has a first end 311 and a second end 312. Simultaneously, the electrode assembly 300 includes a spline connector 330, with the spline 310 disposed at the distal end of the spline connector 330. The spline connector 330 includes a first seat body 331 and a second seat body 332 (e.g., ...). Figure 6 The second seat 332 is embedded within the first seat 331, with the distal end of the second seat 332 exposed beyond the distal end of the first seat 331. The second seat 332 is rotatably disposed on the first seat 331. The first seat 331 is fixedly connected to the first end 311 of the spline 310, and the second seat 332 is fixedly connected to the second end 312 of the spline 310. Figure 2 , Figure 3 , Figure 7 The electrophysiological catheter may include a protective tube 340, which can be sleeved on the outside of the first base 331 to protect and decorate the internal structure. The protective tube 340 can be fixedly connected to the first base 331, for example, by adhesive bonding, and the protective tube 340 can be fixed to the tube body 200. In some other embodiments, the protective tube 340 may be omitted, in which case the outer peripheral surface of the first base 331 can serve as the outer peripheral surface of the corresponding part of the electrophysiological catheter.

[0081] It should be noted that the spline 310 with the folded portion 313 can be of appropriate thickness, cross-sectional shape, and bend profile as needed. For example, the cross-section of the spline 310 can be circular to better fit the target tissue 500 in different orientations. Furthermore, the outline of the bend profile of the spline 310 can be a smooth arc, such as a teardrop shape; it can also be a zigzag profile with corners, such as a triangle; or the outline of the spline 310 can include both straight and curved sections, such as a fan shape.

[0082] In one specific embodiment, please refer to Figures 2 to 5 The spline 310 includes a first portion 321 near the first end 311, a second portion 322 near the second end 312, and an intermediate portion 323 connecting the first portion 321 and the second portion 322. In the unfolded state, the projections of the first portion 321 and the second portion 322 along the axis of the spline connector 330 can both be straight lines, and the first portion 321 and the second portion 322 can be curved in an arc shape, forming an arch convex towards the proximal side of the electrode assembly 300, for example... Figure 3 and Figure 6 .

[0083] In some embodiments, the middle portion 323 can be V-shaped, with its opening facing the spline connector 330. The middle portion 323 forms a corner with the first portion 321 and with the second portion 322. The V-shape of the middle portion 323 allows the portions on both sides of the V-shaped opening to form a guiding structure during the transition of the electrode assembly 300 from an unfolded state to a retracted state, facilitating the intersection of the splines 310 and ensuring the morphological stability of the splines 310. Furthermore, when the splines 310 are in the retracted state, the V-shape of the middle portion 323 facilitates a smoother transition of the contour surface of the electrode assembly 300. It should be noted that the portions on both sides of the V-shaped opening can be straight or curved.

[0084] Considering the stress when the spline 310 is closed and the shape control of the spline 310, in some embodiments, the included angle corresponding to the "V" shape in the unfolded state is not less than 90°. Of course, in some other embodiments, the specific value of the above included angle can also be adjusted as needed.

[0085] In some embodiments, please refer to Figures 5 to 7The spline 310 may include a first elastic skeleton 351, a second elastic skeleton 352, and a connecting tube 353. The two ends of the connecting tube 353 are respectively fitted onto the first elastic skeleton 351 and the second elastic skeleton 352. The middle section of the connecting tube 353 located between the first elastic skeleton 351 and the second elastic skeleton 352 forms an intermediate portion 323. The connection method between the first elastic skeleton 351, the second elastic skeleton 352, and the connecting tube 353 is not limited; for example, it may be adhesive bonding.

[0086] With this structure, the initial positions of the first elastic skeleton 351 and the second elastic skeleton 352 can be determined first, and then the connecting pipe 353 can be installed, which facilitates assembly. If the spline 310 adopts an integral structure, the first end 311 and the second end 312 are connected to the spline connecting seat 330 during assembly. However, due to the small size of the spline 310 and the spline connecting seat 330, this may be difficult to do.

[0087] The materials of the first elastic skeleton 351 and the second elastic skeleton 352 only need to meet the elastic support requirements. They can be metal or non-metal materials commonly used in the art for forming splines, such as nitinol. The material of the connecting tube 353 can be selected as needed, such as TPU (Thermoplastic Urethane), Pebax (Polyether Block Amide), or PA (Polyamide). The connecting tube 353 can form a softer segment at the end of the spline 310, resulting in higher overall safety when the distal end of the electrode assembly 300 is close to the target tissue 500. Of course, in some other embodiments, an intermediate elastic skeleton can also be provided between the first elastic skeleton 351 and the second elastic skeleton 352. The material of the intermediate elastic skeleton can be the same as that of the first elastic skeleton 351 and the second elastic skeleton 352. In this case, the skeleton of the spline 310 can be a single integral skeleton.

[0088] In some embodiments, both the first seat 331 and the second seat 332 can be tubes. The first elastic frame 351 is integrally formed with the first seat 331, and the second elastic frame 352 is integrally formed with the second seat 332. The second seat 332 is coaxially sleeved within the first seat 331. This integral forming method facilitates the positioning of the first elastic frame 351 and the second elastic frame 352. Both the first elastic frame 351 and the second elastic frame 352 can be formed by cutting and bending the tube wall. In other embodiments, the elastic frame and the corresponding seat can also be manufactured separately and fixedly connected, for example, by welding.

[0089] To facilitate the rotation of the second end 312, in the unfolded state, the portion of the first part 321 near the first end 311 and the portion of the second part 322 near the second end 312 are offset along the axial direction of the spline connector 330 to avoid interference when the first part 321 and the second part 322 rotate relative to each other. In one specific embodiment, please refer to... Figure 6 The distal end of the second seat 332 protrudes beyond the distal end of the first seat 331, causing the first end 311 and the second end 312 of the spline 310 to be offset along the axial direction of the spline connector 330. In some other embodiments, the distal end of the second seat 332 may also be flush with the distal end of the first seat 331, or it may be recessed into the first seat 331. In this case, the aforementioned axial offset can be achieved through an extension portion of the second end 312 that extends approximately along the axial direction of the spline connector 330.

[0090] Of course, those skilled in the art will understand that the first end 311 and the second end 312 can be radially offset along the spline connector 330. For example, the tube diameter of the second seat 332 is smaller than the tube diameter of the first seat 331, so that the rotation trajectory of the second end 312 about the axis of the spline connector 330 is located within the circle enclosed by the first end 311, thereby achieving radial offset of the first end 311 and the second end 312.

[0091] In the above embodiments, the first elastic frame 351 is integrally formed with the first seat 331, and the first end 311 is connected to the distal end face of the first seat 331. The second elastic frame 352 is integrally formed with the second seat 332, and the second end 312 is connected to the distal end face of the second seat 332. In some other embodiments, the first end 311 may also be connected to the outer peripheral surface or inner wall surface of the first seat 331, and similarly, the second end 312 may also be connected to the outer peripheral surface or inner wall surface of the second seat 332.

[0092] Electrodes for transmitting electrical energy are distributed on the spline 310 to achieve ablation or mapping. In some embodiments, the electrode includes at least two first electrodes 361 disposed on the first portion 321 and at least two second electrodes 362 disposed on the second portion 322, which can determine the distribution position of the electrodes by relying on the first portion 321 and the second portion 322 to ablate the target tissue 500. The electrode also includes intermediate electrodes 363 disposed on the middle portion 323, with intermediate electrodes 363 disposed on the portions corresponding to the two sides of the "V" shape on the middle portion 323, which can form a greater number of electrodes and can perform point ablation by relying on the intermediate electrodes 363 at the distal end of the electrode assembly 300 when the electrode assembly 300 is closed to a certain extent.

[0093] In some embodiments, the electrode can be an annular electrode surrounding the outer peripheral surface of the spline 310, which facilitates better contact between the electrode and the target tissue 500 when the electrode assembly 300 is in different unfolded and retracted states.

[0094] In some embodiments, in the unfolded state, the distance from the center of any first electrode 361 on the same spline 310 to the axis of the spline connector 330 is different from the distance from the center of any second electrode 362 to the axis of the spline connector 330. In one specific embodiment, three first electrodes 361 may be provided on the first portion 321, while two second electrodes 362 may be provided on the second portion 322. The effect of this structure is that the electrodes can be staggered, forming a wider electric field.

[0095] When the first seat 331 rotates relative to the second seat 332 via the spline 310 and spline connector 330, the electrode assembly 300 has an unfolded state and a retracted state. In the unfolded state, each spline 310 forms a petal shape on the radially outer side of the spline connector 330. In the retracted state, the first end 311 and the second end 312 of any spline 310 are offset along the circumference of the electrode assembly 300, and the spline 310 has a retracted amount that bends toward the distal end of the electrode assembly 300 compared to the unfolded state.

[0096] To achieve relative rotation between the first seat 331 and the second seat 332, in some embodiments, the first seat 331 can be fixed while the second seat 332 rotates, or the first seat 331 can rotate while the second seat 332 is fixed, or both the first seat 331 and the second seat 332 can rotate. Considering the complexity of the structure and the scenario where the electrophysiological catheter needs to enter the human body, fixing the first seat 331 and rotating the second seat 332 is relatively preferable in some cases.

[0097] In some embodiments, spline 310 is a self-expanding spline 310, meaning that spline 310 is in an unfolded state when there is no external driving force, and is used to enter and exit the sheath through its own elastic deformation when subjected to axial pushing and pulling forces. This allows the shape and orientation of spline 310 to be controlled simply by the relative rotation of the first end 311 and the second end 312 of spline 310. Those skilled in the art will understand that the sheath can serve as a channel for the entry and exit of the tube body 200 of the electrophysiological catheter and the electrode assembly 300 into and out of the human body. Its specific structure can be referenced from existing structures in related technologies. Considering that it is not directly related to the innovative content and technical problem to be solved in this application, it will not be described in detail here.

[0098] Those skilled in the art will understand that, in the illustrated embodiment, in the initial state, since the first end 311 of the spline 310 is fixed, and the second end 312 is approximately on the same side of the spline connector 330 as the first end 311, the positions of the first end 311 and the second end 312, along with the folded portion 313 on the spline 310 away from the spline connector 330, will essentially determine the shape and position of the spline 310. When the shape of the spline 310 needs to be adjusted, taking the first seat 331 being fixed and the second seat 332 rotating as an example, the rotation of the second seat 332 causes the second end 312 to rotate around the axis of the spline connector 330. Since the second end 312 moves to a side of the spline connector 330 different from the position of the first end 311, the space enclosed by the spline 310 will span at least a portion of the spline connector 330, and the spline 310 will be closer to the axis of the spline connector 330 than in its unfolded state, thus resulting in a retraction. Please refer to... Figure 2 and Figure 3 When the spline 310 is in the unfolded state, it is tilted towards the far end of the electrode assembly 300, which makes it easier for the spline 310 to close.

[0099] In some embodiments, the folded state includes the following configuration: at least one spline 310 enters the space enclosed by another spline 310 (e.g., Figure 14 This allows for a smaller convergence diameter. In some embodiments, the convergence state includes the following configuration: the first end 311 and the second end 312 of the same spline 310 are located on opposite sides of the spline connector 330, that is, the line connecting the first end 311 and the second end 312 intersects the rotation axis of the second seat 332 (e.g., Figure 18 The current state of spline 310 can be taken as the limit of convergence.

[0100] In some embodiments, the first seat 331 of the electrode assembly 300 can be fixed to the tube body 200, while the drive rod 400 of the electrophysiological catheter (e.g., Figure 20 The distal end of the inner tube 220 can be connected to the second seat 332 to drive the second seat 332 to rotate. The operating handle 100 includes a drive module, and the proximal end of the drive rod 400 is connected to the drive module. The drive module is used to drive the drive rod 400 to rotate. The specific structure of the drive module is not limited, as long as it can realize the forward and reverse rotation of the drive rod 400. It can be manually driven or electrically driven. For example, a wheel can be mounted on the operating handle 100, and the proximal end of the drive rod 400 can be fixed on the wheel. The wheel has an operating part exposed outside the operating handle 100, and the user can rotate the driving rod 400 by rotating the operating part. The specific structure of the drive rod 400 is not limited, for example, it can be a solid rod or a hollow rod.

[0101] To obtain the rotation angle when the drive rod 400 drives the second seat 332 to rotate, in some embodiments, please refer to... Figures 20 to 23 The electrode assembly 300 also includes a first sensor 371 and a second sensor 372. The first sensor 371 is disposed on the first base 331, and is not coaxial with the second base 332. The detectable signal of the first sensor 371 includes the spatial position of the first sensor 371 relative to the rotation axis of the second base 332. The second sensor 372 is disposed on the second base 332, and is coaxially arranged with the second base 332. The detectable signal of the second sensor 372 includes the rotation angle of the second base 332. The fixing method of the first sensor 371 and the second sensor 372 is not limited; for example, they can be fixed by adhesive. In some other embodiments, the second base 332 and the inner tube 220 can be an integral structure.

[0102] It should be noted that the first sensor 371 and the second base 332 are not coaxial. Therefore, the rotation axes of the first sensor 371 and the second base 332 do not coincide. Specifically, the first sensor 371 can be parallel to the second base 332 and spaced apart. Alternatively, the first sensor 371 can be arranged such that its axis intersects or spatially crosses the rotation axis of the second base 332. For the second sensor 372, the rotation angle of the second base 332 it detects is also the rotation angle of the second sensor 372 itself around the axis of the second base 332.

[0103] In use, the second sensor 372 can be used to obtain the corresponding pose of the second seat 332, including the rotation angle around its own longitudinal axis. The second sensor 372 can be used to obtain the corresponding pose of the second seat 332. Combined with the position of the rotation axis of the second sensor 372, the rotation angle of the second sensor 372 relative to the first sensor 371 can be determined, that is, the rotation angle of the second seat 332 relative to the first seat 331.

[0104] In some embodiments, the first sensor 371 and the second sensor 372 are columnar structures, and the axes of both the first sensor 371 and the second sensor 372 are parallel to the rotation axis of the second base 332. This facilitates the establishment of a coordinate system and saves space, avoiding an increase in the diameter of the electrophysiological catheter. In some other embodiments, the first sensor 371 and the second sensor 372 can be replaced with other structural forms, such as a chip structure.

[0105] Those skilled in the art will understand that the coordinate system of the sensor can be a Cartesian coordinate system, including three mutually perpendicular axes and rotational directions about each axis, each axis and rotational direction about each axis can correspond to a degree of freedom. In some embodiments, the first sensor 371 is at least a 5-DOF magnetic sensing coil, and the detectable signals include coordinates along its own axis, two-dimensional coordinates perpendicular to its own axis, and rotations about each axis of the two-dimensional coordinate system; and / or, the second sensor 372 is at least a 6-DOF magnetic sensing coil, and the detectable signals include coordinates along its own axis, two-dimensional coordinates perpendicular to its own axis, rotations about its own axis, and rotations about each axis of the two-dimensional coordinate system. This facilitates a more comprehensive acquisition of the pose information of the first sensor 371 and the second sensor 372. Of course, the detectable signals of each sensor can also be changed according to usage requirements.

[0106] In some embodiments, the first sensor 371 can be a 5-DOF magnetic sensor, and the second sensor 372 can be a 6-DOF magnetic sensor. It should be noted that magnetic sensors are commonly used in electrophysiological catheters and can be made of coils. During use, a magnetic field is established around the patient; as the coil's orientation changes, the magnetic flux also changes, thus enabling position detection. For a 6-DOF magnetic sensor, it can be composed of two 5-DOF magnetic sensors combined in a non-coaxial manner to detect the rotation angle around its own axis. The specific structure of the aforementioned magnetic sensors can be referenced from existing structures in related technologies; however, considering that it is not directly related to the innovative content and technical problem to be solved in this application, it will not be elaborated further here.

[0107] In some embodiments, the second sensor 372 is disposed in the inner cavity of the second seat 332 in the form of a tube, while at least a portion of the first sensor 371 is located radially outside the second sensor 372, which facilitates more accurate calculation of the relative positional change between the first sensor 371 and the second sensor 372.

[0108] Because electrophysiological catheters are often small in diameter, in order to meet spatial arrangement requirements while simultaneously placing the first sensor 371 and the second sensor 372, in some embodiments, the projection of the first seat 331 along a direction parallel to the rotation axis of the second seat 332 is at least partially coincident with the projection of the first sensor 371. For example, a receiving space can be provided on the side wall of the first seat 331, and at least a portion of the first sensor 371 can be disposed in the receiving space. In one specific embodiment, for the first seat 331 in the above-described tube form, a slot 3311 is provided on the side wall of the tube, forming a receiving space. The axis of the sensor can coincide with the side wall of the tube. In some embodiments, the first sensor 371 can also be offset from the first seat 331 along the catheter axis, which also allows the projection of the first seat 331 and the first sensor 371 to at least partially coincide.

[0109] The slot 3311 on the first base 331 exposes the first sensor 371. Additionally, the outer periphery of the first base 331 may require other structures, resulting in unevenness. In some embodiments, the electrode assembly 300 includes a protective tube 340, which is fixedly fitted over the outside of the first base 331, with the first sensor 371 completely within the protective tube 340. The protective tube 340 and the first base 331 can be bonded together using adhesive.

[0110] The first seat 331 can be fixedly connected to the distal end of the outer tube 210, and the second seat 332 can be fixedly connected to the distal end of the inner tube 220. In this way, the first seat 331 can be fixed by the outer tube 210, while the second seat 332 can rotate with the inner tube 220. The inner tube 220 is used as a driving element to realize the shape adjustment of the electrode assembly 300.

[0111] To meet the perfusion fluid supply requirements during the use of the electrophysiological catheter, the insertion assembly also includes an perfusion tube 230 for bending with the inner bend 221. The perfusion tube 230 is fitted over the inner bend 221 and forms a fluid channel 250 between the inner bend 221 and the inner bend 221 for fluid passage. Figure 23 (As shown more clearly in the filled pattern), the fluid channel 250 leads to the distal side of the insertion assembly. The insertion assembly also includes a supply tube 240, the distal end of which communicates with the proximal end of the fluid channel 250. The supply tube 240 can be routed along the insertion assembly to the operating handle 100 and then extended from the operating handle 100 to connect to an external perfusion fluid supply device, allowing perfusion fluid to be delivered to the distal side of the electrode assembly 300.

[0112] In some embodiments, please refer to Figure 22 , Figure 23The inner bending section 221 includes a flexible core 2211 and a flexible sealing tube 2212 fitted over the core 2211. The core 2211 is made of a rigid material and has a flexible structure. The flexible structure forms a gap in the wall of the core 2211, and the flexible sealing tube 2212 forms a sealing layer on the outside of the core 2211. The flexible structure forming a gap in the wall of the core 2211 provides better bending performance for the inner bending section 221, while the sealing layer formed by the flexible sealing tube 2212 on the outside of the core 2211 can seal the gap, laying the foundation for establishing the fluid channel 250.

[0113] In some embodiments, the flexible sealing tube 2212 can be a polymer material tube, such as PI (Polyimide). The molding method of the flexible sealing tube 2212 on the core 2211 is not limited. For example, it can be fitted onto the flexible structure and sealed by heat shrinking, elastic shrinking, or bonding, or it can be directly attached to the flexible structure to form a tubular structure by coating or dip-coating. In some other embodiments, the flexible sealing tube 2212 can also be made of other materials, such as Pebex, TPU, PTFE, silicone, etc.

[0114] Please refer to Figure 22 In some embodiments, the outer bending section 211 may include an outer tube 2111, an inner tube 2112 embedded within the outer tube 2111, and a braided layer 2113 disposed between the outer tube 2111 and the inner tube 2112. The braided layer 2113 and the outer tube 2111 can be combined to form a composite layer. For example, after the braided layer 2113 is braided on the inner tube 2112, the outer tube 2111 can be fitted on top, and the outer tube 2111 and the braided layer 2113 can be fused together by hot pressing. Alternatively, after the braided layer 2113 is braided on the inner tube 2112, a heated fluid can be used to coat the braided layer 2113, and after cooling, the outer tube 2111 is formed, thus fusing the outer tube 2111 and the braided layer 2113. The above structure is beneficial for improving the structural strength and fatigue resistance of the outer bending section 2111 and for ensuring effective torque transmission. The outer main body section 212 of the outer tube 210 can adopt the same structure as the inner tube 2112.

[0115] The specific structure of the injection pipe 230 is not limited; for example, it can be a corrugated pipe, which can better adapt to the bending of the inner bend section 221 and help ensure the cross-sectional stability of the fluid channel 250 during bending. In some other embodiments, the injection pipe 230 can also be a straight-walled pipe. Additionally, please refer to... Figure 22 The corrugated pipe may include a straight pipe section at the distal end, which helps to ensure that the fluid is smoothly discharged from the distal end of the fluid channel 250, thereby helping to ensure the injection volume and reduce the injection pressure.

[0116] In one specific embodiment, the core 2211 may include multiple wires arranged side by side, which are spirally wound to form a tubular structure, similar to a multi-threaded thread. The wires can be stainless steel wire, nickel-titanium alloy wire, or precious metal wire. The number of strands can be set as needed. Multiple wires arranged side by side have higher mechanical properties than a single wire, which is beneficial for more complete transmission of torque from the proximal end to the distal end, and also facilitates stable rotation in narrow, tortuous blood vessels.

[0117] Those skilled in the art will understand that the flexible structure can be a thallium tube structure or a serpentine structure. The specific structure of the thallium tube structure or the serpentine structure can refer to existing structures in related technologies, which can realize the bending of the catheter or sheath, for example, it can be used for the bending section of the catheter or sheath.

[0118] For a slub tube structure, it may include a first groove and a second groove respectively disposed on opposite sides of the tube wall of the core 2211. The depth of the first groove and the second groove is less than the radius of the core 2211, and the first groove and the second groove are offset along the axial direction of the core 2211. In some other embodiments, the first groove and the second groove may also be arranged aligned. For a serpentine structure, as an example, slots can be formed by laser cutting grooves on the side wall of the tube, and these slots can provide deformation space for the bending of the core 2211. For a serpentine structure, the flexible structure may also be a hinged structure disposed between two adjacent serpentine unit sections. Such a hinged structure can refer to existing structures in related technologies, and will not be described in detail here.

[0119] In one specific embodiment, the rigid material used for the core 2211 can be a metal material, such as nitinol or stainless steel, which can provide better mechanical properties and more effectively transmit torque. Similarly, the inner body section 222 can also be a metal tube, and the material can also be nitinol, stainless steel, etc., to more effectively transmit torque.

[0120] To connect the supply tube 240 and the infusion tube 230, in some embodiments, the insertion assembly includes an adapter sleeve 231, which is fitted onto the inner tube body 220. The distal end of the adapter sleeve 231 communicates with the proximal end of the infusion tube 230. The sleeve wall of the adapter sleeve 231 includes a first arc-shaped portion, a second arc-shaped portion, and two transition portions. The first arc-shaped portion and the second arc-shaped portion are located on opposite sides of the adapter sleeve 231 in the circumferential direction. The inner wall of the first arc-shaped portion matches the corresponding side of the inner tube body 220, and the inner wall of the second arc-shaped portion matches the corresponding side of the supply tube 240. The two transition portions are respectively connected between the two sides of the first arc-shaped portion and the corresponding side of the second arc-shaped portion. The adapter sleeve 231 with the above structure can control the radial dimension of the adapter sleeve 231 while enabling the liquid supply pipe 240 to connect with the fluid channel 250. This is beneficial for the overall rotation of the integrated structure formed by the inner tube 220, adapter sleeve 231, injection pipe 230 and liquid supply pipe 240.

[0121] Those skilled in the art will understand that the proximal end of the aforementioned adapter sleeve 231 and the distal end of the inner main body section 222 and the distal end of the liquid supply pipe 240 have a sealing structure. The specific form of the sealing structure is not limited. For example, it can be sealed by injection and bonding, sealed by interference fit, or sealed by setting a sealing ring.

[0122] In some embodiments, the liquid supply pipe 240 is parallel to the inner main body section 222 and is disposed on one side of the inner main body section 222. This design is simple and facilitates smooth flow of fluid within the liquid supply pipe 240. Furthermore, the liquid supply pipe 240 can employ an offset structure within the pipe body 200, with the outer pipe body 210, inner pipe body 220, and injection pipe 230 arranged coaxially. This helps ensure that the inner pipe body 220 extends along the axis of the insertion assembly center, thereby ensuring the coaxiality of the second seat 332 and the first seat 331 of the electrode assembly 300.

[0123] In some embodiments, when the inner tube 220 is a hollow tube, at least a portion of the lead wires on the electrode assembly 300 are led out from the inner tube 220. For example, the lead wires on the second portion 322 of the spline 310 can be led out from the inner tube 220. Of course, the lead wires on the first portion 321 and the second portion 322 of the spline 310 can also be led out from the inner tube 220. If other electronic components, such as a magnetic sensor, are provided on the electrode assembly 300, the lead wires connected to the magnetic sensor can also be led out from the inner tube 220.

[0124] It should be noted that in some other embodiments, the insertion component may also refer to the part that does not include the electrode component 300 described above, that is, the part corresponding to the tube body 200.

[0125] With the injection pipe 230 and supply pipe 240 of the above structure, the inner tube 220 can realize torque transmission and bending while delivering injection fluid through the supply pipe 240 and fluid channel 250.

[0126] Whether the electrode assembly 300 is in the deployed or retracted state, it can be used for ablation or mapping, and the degree of retraction can be adapted to different application scenarios. Below, in conjunction with... Figures 8 to 19 Several possible application scenarios will be introduced.

[0127] Please refer to Figure 8 and Figure 9 At this point, the electrode assembly 300 is in the deployed state. The target tissue 500 to be ablated is the posterior wall of the left atrium. The electrode assembly 300 can cover the posterior wall of the left atrium. Under the reaction force of the posterior wall of the left atrium, each spline 310 deforms, becoming approximately a planar structure, enabling ablation of the entire posterior wall of the left atrium. This allows for the rapid and effective formation of multiple large-area sheet-like ablation zones in one operation, isolating abnormal electrical signals from the target tissue 500. The desired ablation shape can be achieved by configuring the electrodes with different polarities. For example, electrodes located on both sides of the fold 313 on the same spline 310 can be configured with different polarities; or, electrodes on the same spline 310 can be configured with the same polarity, while electrodes on adjacent splines 310 can be configured with opposite polarities; or, adjacent electrodes on the same spline 310 can be arranged with alternating polarities.

[0128] Please refer to Figure 10 and Figure 11 At this time, the electrode assembly 300 is also in the deployed state. The target tissue 500 to be ablated is the pulmonary vein vestibule. The pulmonary vein vestibule is covered by the electrode assembly 300. Under the reaction force of the posterior wall of the left atrium, each spline 310 deforms and forms a reverse bend towards the proximal side of the electrode assembly 300, which can ablate the entire pulmonary vein vestibule. At this time, the first electrode 361 and the second electrode 362 adjacent to the middle part 323, as well as the intermediate electrode 363 on the middle part 323, can be configured as positive electrodes, while the remaining first electrodes 361 and the second electrode 362 can be configured as negative electrodes.

[0129] Please refer to Figures 12 to 14At this point, the electrode assembly 300 is in a retracted state, but not yet at its retracted limit, suitable for scenarios where the target tissue 500 to be ablated is the pulmonary vein orifice. During the ablation operation, the electrode assembly 300 can first be fully retracted and inserted into the pulmonary vein orifice. Then, the electrode assembly 300 can be opened to a semi-open state, allowing each spline 310 to abut against the inner wall of the pulmonary vein orifice for ablation. At this time, the polarity configuration of the electrodes can be the same as when ablating the pulmonary vein vestibule; roughly, the electrodes on the distal half of the bud-like structure formed by the retracted electrode assembly 300 are configured as positive electrodes, while the electrodes on the proximal half are configured as negative electrodes. Even if the distal electrodes of the electrode assembly 300 touch, the same polarity will not affect the ablation discharge.

[0130] Please refer to section 15. Figure 19 At this point, the electrode assembly 300 is in a fully retracted state, which is suitable for cases where the target tissue 500 to be ablated is the posterior wall / isthmus line (the ablation line connecting the anterior inferior margin of the left inferior pulmonary vein (LIPV) and the mitral valve annulus). Point ablation of the target tissue 500 can be performed through the tip or side. In this case, the polarity configuration of the electrode can also be the same as in the previous scenario.

[0131] It should be noted that the polarity configuration of the electrodes described above is only an example, and those skilled in the art can use other polarity configurations as needed. In addition, the number of splines 310 can be 2, 3, 4, 5, 6, 7, 8, 9 or 10, or even more. Each spline 310 can be evenly distributed along the circumference of the spline connector 330 to form a uniform electrode structure.

[0132] Those skilled in the art will understand that the above-mentioned operating handle 100, tube body 200 and electrode assembly 300, except for the parts related to the improvements of this application, can refer to existing structures in related technologies. Considering that they are not directly related to the innovative content of this application and the technical problem to be solved, they will not be described in detail here.

[0133] The electrophysiological catheter in this application uses a method of relative rotation between the first end 311 and the second end 312 of the spline 310 to control the shape of the electrode assembly 300. This method is simple to operate, has good usability, and provides stable electrode positioning. Furthermore, the electrode assembly 300 has an unfolded state and different degrees of retraction. When facing large-diameter pulmonary veins, it can be used in a petal shape to conform to the pulmonary vein; when facing small-diameter pulmonary veins, it can be used in a bud shape for ablation. It can also be retracted and extended into the lumen, and then further unfolded to conform to the inner wall of the lumen. This flexible usage method and wider applicability make the product better able to handle different types of arrhythmias.

[0134] Furthermore, since petal-shaped or basket-shaped catheters currently on the market often require guidewire guidance, and each spline 310 needs to be merged at the tip, and different shapes of the electrode assembly 300 need to be formed by push-pull drive rods, the setting of the guide is unavoidable. This results in such products only being able to perform pulmonary vein ablation and not being able to be used for ablation in other parts of the heart. However, the electrophysiological catheter in this application, because the spline 310 is connected by the first end 311 and the second end 312, does not require a guide structure, making the entire distal end flatter and without protrusions in the middle, thus making it safer when applied to the endocardium and allowing for greater freedom of operation for the user.

[0135] For basket-type or petal-type conduits that unfold and retract by relative movement of their proximal and distal ends along the conduit axis, it is often necessary to place a sensor at the proximal and distal ends of the electrode assembly 300 to obtain the pose of the electrode assembly 300. In the embodiments of this application, the first sensor 371 and the second sensor 372, in addition to obtaining the relative rotation angle of the first seat 331 and the second seat 332 to determine the unfolded state of the spline 310, can also simultaneously obtain the pose of the electrode assembly 300.

[0136] It should be noted that the electrode assembly 300 capable of achieving a flower bud shape described above is merely an example where the unfolding and retracting states are adjusted by rotating the drive rod 400. In some embodiments, the sensor configuration described above can also be used for other electrophysiological catheters that require rotation of the drive rod 400. Furthermore, the electrophysiological catheter described above can be connected to a corresponding host computer for processing of the sensor signals.

[0137] Embodiments of the electrode assembly of the electrophysiological catheter in this application:

[0138] Its structure is the same as that of the electrode assembly in the above-described electrophysiological catheter embodiment, and will not be described again here.

[0139] The above examples illustrate the invention and are intended only to aid understanding, not to limit its scope. Those skilled in the art can make various simple deductions, modifications, or substitutions based on the ideas presented in this invention.

Claims

1. An electrode assembly for an electrophysiological catheter, characterized in that, include: Splines, wherein electrodes are provided for transmitting electrical energy; And a spline connector, wherein the spline is disposed on the distal end of the spline connector, the spline connector includes a first body and a second body, the second body is embedded in the first body, the distal end of the second body is exposed to the distal end of the first body, and the second body is rotatably disposed on the first body; A first sensor is mounted on the first base. The first sensor is not coaxial with the second base. The detectable signal of the first sensor includes the spatial position of the first sensor relative to the rotation axis of the second base. The second sensor is mounted on the second base and is coaxially arranged with the second base. The detectable signal of the second sensor includes the rotation angle of the second base.

2. The electrode assembly as described in claim 1, characterized in that, The first sensor and the second sensor are columnar structures, and the axes of the first sensor and the second sensor are parallel to the rotation axis of the second base.

3. The electrode assembly as described in claim 2, characterized in that, The first sensor is at least a 5-DOF magnetic sensing coil, capable of detecting signals including coordinates along its own axis, two-dimensional coordinates perpendicular to its own axis, and rotations about each axis of the two-dimensional coordinate system; and / or, the second sensor is at least a 6-DOF magnetic sensing coil, capable of detecting signals including coordinates along its own axis, two-dimensional coordinates perpendicular to its own axis, rotations about its own axis, and rotations about each axis of the two-dimensional coordinate system.

4. The electrode assembly as described in any one of claims 1 to 3, characterized in that, The projection of the first seat and the first sensor is at least partially coincident when projected along a direction parallel to the rotation axis of the second seat.

5. The electrode assembly as described in claim 4, characterized in that, The first base has a receiving space on its side wall, and at least a portion of the first sensor is disposed in the receiving space.

6. The electrode assembly as described in claim 5, characterized in that, The first seat is a tube, and the side wall of the tube is provided with a groove, which forms the receiving space.

7. The electrode assembly as described in any one of claims 1 to 3, characterized in that, The electrode assembly includes a protective tube, which is fixedly fitted onto the outside of the first base body, and the first sensor is completely located inside the protective tube.

8. The electrode assembly as described in any one of claims 1 to 3, characterized in that, The second seat is a tube, the second sensor is disposed in the inner cavity of the second seat, and at least a portion of the first sensor is located radially outside the second sensor.

9. The electrode assembly as described in any one of claims 1 to 3, characterized in that, The spline is elastically deformable, the spline is a linear structure, and the spline has a first end and a second end; The first seat is fixedly connected to the first end of the spline, the second seat is fixedly connected to the second end of the spline, and the side of the spline away from the spline connecting seat has a reverse fold portion; When the first seat rotates relative to the second seat, the electrode assembly has an unfolded state and a retracted state; in the unfolded state, each spline forms a petal shape on the radially outer side of the spline connector; in the retracted state, the first end and the second end of any spline are offset along the circumference of the electrode assembly, and the spline has a retracted amount that bends toward the distal end of the electrode assembly compared to the unfolded state.

10. An electrophysiological catheter, characterized in that, It includes an operating handle, a tube body, and an electrode assembly connected sequentially from the proximal end to the distal end, wherein the electrode assembly is the electrode assembly according to any one of claims 1 to 9, and the first seat of the electrode assembly is fixed to the tube body; It also includes a drive rod, the distal end of which is connected to the second base to drive the second base to rotate. The operating handle includes a drive module, the proximal end of which is connected to the drive module, and the drive module is used to drive the drive rod to rotate.

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