Spline of basket catheter, basket electrode assembly, and method for fabricating spline
By combining a flexible reinforcing member and a distal heat shrink tubing on the spline of the basket-shaped conduit, the problems of high manufacturing difficulty and poor fatigue resistance of the spline are solved, enabling flexible bending and high-strength connection of the spline, thus improving the safety and reliability of the conduit.
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- ENCHANNEL MEDICAL GUANGZHOU INC
- Filing Date
- 2025-01-06
- Publication Date
- 2026-07-09
AI Technical Summary
The spline of the existing basket-shaped conduit is difficult to manufacture, and the integrated connection at the distal end of the support results in poor fatigue resistance, making it difficult to achieve the designed expansion and contraction shapes.
The system employs a combination structure of flexible reinforcement and distal heat shrink tubing. The flexible reinforcement is stacked with the flexible circuit board, and the distal heat shrink tubing wraps around the extension of the flexible reinforcement and the circuit board to form a distal bending section, which is used to bend during expansion and contraction to avoid excessive stress at the distal end of the spline.
It improves the bending flexibility and fatigue strength of the spline, is easy to manufacture, reduces stress concentration, and enhances the safety and reliability of the conduit.
Smart Images
Figure CN2025070773_09072026_PF_FP_ABST
Abstract
Description
Splines of basket-shaped conduits, basket electrode assemblies and spline manufacturing methods Technical Field
[0001] This application relates to the field of electrophysiological catheter technology, specifically to the spline of a basket-shaped catheter, a basket electrode assembly, and a method for manufacturing the spline. Background Technology
[0002] Using a spherical basket-shaped ablation catheter, the electric field generated by short-duration high-voltage pulses released from its electrodes can ablate target tissues, achieving the clinical treatment of arrhythmias. The spherical catheter tip allows the basket electrode assembly to better adhere to the local tissue, resulting in better ablation effects; at the same time, the corresponding basket structure allows for greater flexibility in catheter application, buffering the pressure when applying pressure to the target tissue and achieving lower pressure.
[0003] Currently, there are relatively few spherical net basket structures on the market. The main reason is that the overall structural rigidity of the net basket electrode assembly needs to be considered during the research and development process. Often, the support of the net basket electrode assembly is processed as a whole, and the far ends of each spline are connected as one piece. During the process of the support closing and expanding, the far end bears greater stress, has poor fatigue resistance, and it is not easy to achieve the designed expansion and closing shape, making manufacturing difficult. Summary of the Invention
[0004] This application mainly addresses the technical problem of the difficulty in manufacturing the splines of basket-shaped conduits.
[0005] One embodiment provides a spline of a basket-shaped conduit.
[0006] The splines of basket-shaped vessels include:
[0007] Strip-shaped elastic sheet;
[0008] A flexible reinforcement member is provided along the spline, the flexible reinforcement member has a fixed portion and an extended portion, the fixed portion is connected to the elastic sheet, and the extended portion extends beyond the distal end of the elastic sheet;
[0009] A flexible circuit board, fixed to the elastic sheet, the flexible circuit board including electrodes for transmitting electrical energy; the flexible circuit board having an extension portion extending beyond the distal end of the elastic sheet and stacked with an extension portion of the flexible reinforcement;
[0010] And a distal heat shrink tubing, a portion of which wraps around the overlapping section of the flexible circuit board and the elastic sheet, and another portion of which wraps around the extension of the flexible reinforcement and the extended portion of the flexible circuit board, thereby forming a distal bend at the distal end of the spline, the distal bend being used to bend when the basket electrode assembly expands and contracts.
[0011] One embodiment provides a basket electrode assembly.
[0012] The basket electrode assembly includes:
[0013] Splines, the splines described above, are distributed at circumferential intervals along the basket electrode assembly;
[0014] A proximal fixing seat is fixedly connected to the proximal end of each spline;
[0015] And a remote fixing seat, wherein the remote fixing seat is fixedly connected to the remote curved portion of the distal end of each spline.
[0016] One embodiment provides a method for manufacturing the spline of a basket-shaped conduit.
[0017] A method for manufacturing splines of basket-shaped ducts includes the following steps:
[0018] Step 1: A flexible reinforcement is provided on the strip-shaped elastic sheet. The flexible reinforcement is provided along the spline and has a fixed portion connected to the elastic sheet and an extended portion extending beyond the distal end of the elastic sheet.
[0019] Step 2: Fix the flexible circuit board onto the elastic sheet. The flexible circuit board includes electrodes for transmitting electrical energy. The flexible circuit board has an extended portion that extends beyond the distal end of the elastic sheet and is stacked with the extended portion of the flexible reinforcement.
[0020] Step 3: Apply the distal heat shrink tubing, so that the first part of the distal heat shrink tubing wraps around the overlapping section of the flexible circuit board and the elastic sheet, and the second part wraps around the extended portion of the flexible reinforcement and the extended portion of the flexible circuit board. Heat the distal heat shrink tubing so that the first part shrinks and hugs the overlapping section, and the second part shrinks and hugs the extended portion and the extended portion, forming a distal bend at the distal end of the spline. The distal bend is used to bend when the basket electrode assembly expands and contracts.
[0021] The beneficial effects of this application are:
[0022] According to the spline of the aforementioned basket-shaped conduit, a flexible reinforcing member is provided on the spline. The extended portion of the flexible reinforcing member extending beyond the elastic sheet overlaps with the extended portion of the flexible circuit board extending beyond the elastic sheet. Furthermore, the first part of the distal heat-shrink tubing wraps the overlapping section of the flexible circuit board and the elastic sheet, and the second part wraps the extended portion of the flexible reinforcing member and the extended portion of the flexible circuit board. The second part of the distal heat-shrink tubing, the extended portion of the flexible reinforcing member, and the extended portion of the flexible circuit board overlap, forming a distal bending portion at the distal end of the spline. This distal bending portion is used to bend when the basket electrode assembly expands and contracts, which can avoid large stress at the distal end of the spline, providing good bending flexibility. Moreover, the distal heat-shrink tubing and the flexible reinforcing member can achieve a certain bending fatigue strength, which is beneficial for easily avoiding excessive stress while achieving flexible bending of the spline. Each spline can be manufactured individually and then connected between the distal fixing seat and the proximal connecting seat. The distal heat-shrink tubing and the flexible reinforcing member can also be easily set, thus facilitating the manufacturing of the spline. Attached Figure Description
[0023] Figure 1 is a structural diagram of an embodiment of the basket-shaped catheter in this application;
[0024] Figure 2 is a perspective view of the basket electrode assembly in Figure 1;
[0025] Figure 3 is the front view of Figure 2;
[0026] Figure 4 is a 3D view of one of the splines;
[0027] Figure 5 is a cross-sectional view of Figure 3, with the cutting plane passing through the axis of the basket electrode assembly;
[0028] Figure 6 is a magnified view of the distal part of the spline in Figure 5;
[0029] Figure 7 is a magnified view of the upper left part of Figure 5;
[0030] Figure 8 is a structural schematic diagram of another embodiment of the basket electrode assembly in Figure 1;
[0031] Figure 9 is a cross-sectional view AA of Figure 8;
[0032] Figure 10 is a partial enlarged view of the distal fixing seat in Figure 9;
[0033] Figure 11 is a perspective view of another embodiment of the basket electrode assembly;
[0034] Figure 12 is a cross-sectional view of the basket electrode assembly in Figure 11.
[0035] List of feature names corresponding to the labels in the figure:
[0036] 100. Operating handle;
[0037] 200. Pipe body;
[0038] 300. Basket electrode assembly;
[0039] 310. Spline; 311. Elastic sheet; 3111. Distal transition section; 3112. Distal transition section; 3113. Bending portion; 3114. Straight portion; 312. Flexible circuit board; 3121. Insulating substrate; 3122. Electrode; 3123. Extended portion; 313. Distal bending portion; 3131. Bending portion; 3132. Connecting portion; 314. Flexible reinforcement; 3141. Fixing portion; 3142. Extension portion; 315. Distal heat shrink tubing; 316. Main heat shrink tubing;
[0040] 320. Proximal fixation base;
[0041] 330. Remote mounting base; 331. Mounting cavity; 332. Through channel; 3321. First step; 3322. Second step; 333. Positioning groove;
[0042] 340. End cap;
[0043] 350. Functional components;
[0044] 360. Base lead wire; 361. Sheath tube; 362. Flexible frame; 363. Transmission line; 364. Flexible telescopic section; 365. Straight section. Detailed Implementation
[0045] 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.
[0046] 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.
[0047] 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).
[0048] In the embodiments of this application, each spline is a separate part, and at the far end of the spline, the extension portion of the far end heat shrink tubing, the flexible reinforcement, and the extended portion of the flexible circuit board overlap, forming a far end bend at the far end of the spline. The far end bend is used to bend when the basket electrode assembly expands and contracts, which can avoid excessive bending stress at the far end of the elastic sheet and is easy to manufacture.
[0049] Examples of basket-shaped catheters in this application:
[0050] Please refer to Figure 1. In one embodiment, the basket-shaped conduit includes an operating handle 100, a tube body 200, and a basket electrode assembly 300, which are connected sequentially from the proximal end to the distal end of the basket-shaped conduit.
[0051] Those skilled in the art should understand that the terms "proximal" and "distal" used in this document are conventional medical terms. For the instrument to be operated, the proximal end is the end closer to the operator, and the distal end is the end farther from the operator. The distal end is usually the end that first enters the patient's body. The proximal and distal ends can be referred to in the diagram for their orientation. Correspondingly, the proximal-distal direction refers to the distribution direction of the proximal and distal ends of the corresponding components, while the circumferential direction refers to the direction of the axis around the corresponding component that is parallel to the proximal-distal direction.
[0052] The operating handle 100 allows the operator to grip and perform corresponding operations. Its specific operating functions can be designed as needed, such as for adjusting the bending section at the distal end of the basket-shaped conduit. The tube body 200 is connected to the distal end of the operating handle 100. The operating handle 100 and the tube body 200 can drive the basket electrode assembly 300 to move. The tube body 200 can also provide a substrate for laying out corresponding circuits and / or fluid circuits, allowing the corresponding circuits and / or fluid circuits to pass from the operating handle 100 to the basket electrode assembly 300.
[0053] Please refer to Figures 2 to 3 and Figure 5. The basket electrode assembly 300 includes a spline 310, a proximal fixing base 320, and a distal fixing base 330. The specific structure of the basket electrode assembly 300 is described below.
[0054] The splines 310 of the basket electrode assembly 300 are distributed at intervals along the circumference of the basket electrode assembly 300, and the number can be set as needed. For example, in the illustrated embodiment, there are 6 splines 310.
[0055] In some embodiments, each spline 310 is a curved structure in its free state, so that the basket electrode assembly 300 is in an expanded shape, such as a sphere, in its free state. It should be noted that a curved spline 310 means that at least a portion of the spline 310 is curved, and the specific shape can be determined according to the required expansion shape of the basket electrode assembly 300. This structural form of the spline 310 makes the basket electrode assembly 300 a self-expanding basket electrode assembly 300. When the basket electrode assembly 300 retracts into the sheath, the sheath compresses the spline 310, causing the spline 310 to gradually elastically deform and straighten, and the basket electrode assembly 300 contracts into a tubular shape; when the basket electrode assembly 300 emerges from the sheath opening at the distal end of the sheath, the spline 310 gradually returns to its curved shape, and the basket electrode assembly 300 can self-expand and spring back into its expanded shape.
[0056] In some other embodiments, the shape change of the basket electrode assembly 300 can also be controlled by a drive rod. Specifically, the drive rod can pass through the tube 200 and can extend and retract within the tube 200. The distal end of the drive rod is connected to the distal fixing seat 330, and the proximal end of the drive rod is connected to the drive mechanism within the operating handle 100. In use, the operator operates the drive mechanism to extend or retract the drive rod, thereby changing the shape of the basket electrode assembly 300. When the drive rod extends to the distal end, the distance between the distal fixing seat 330 and the proximal fixing seat 320 increases, the spline 310 is straightened by the distal fixing seat 330, and the basket electrode assembly 300 gradually forms a closed shape. Conversely, when the drive rod retracts to the proximal end, the distance between the distal fixing seat 330 and the proximal fixing seat 320 decreases, the spline 310 is bent by the pressure of the distal fixing seat 330, and the basket electrode assembly 300 gradually forms an expanded shape.
[0057] In some embodiments, spline 310 may include a support frame and electrodes 3122. In one specific embodiment, spline 310 includes an elastic sheet 311 for forming the support frame and a flexible circuit board 312 for setting the electrodes 3122. The self-expanding and springing force of the basket electrode assembly 300 can be provided by the elastic sheet 311. The elastic sheet 311 is elastic and, in some embodiments, can be made of an elastic metal, such as a nickel-titanium alloy. Nickel-titanium alloys are shape memory alloys with good biocompatibility and can rebound well to their initial shape after being deformed by external force. Of course, in some other embodiments, the elastic sheet 311 can also be made of other materials, such as non-metallic materials. In some other embodiments, spline 310 can also be replaced with other structural forms. For example, the support frame can also be a columnar frame, and the electrodes 3122 can be annular electrodes 3122 arranged around the elastic frame 362.
[0058] In one specific embodiment, the flexible circuit board 312 may include an insulating substrate 3121 and electrodes 3122 for transmitting electrical energy. Those skilled in the art will understand that the insulating substrate 3121 may be made of polyimide (PI), polyethylene terephthalate (PET), etc., while the electrodes 3122 may be made of platinum-iridium alloy, stainless steel alloy, copper, etc., and a coating may be applied to the surface of the electrodes 3122 to meet corresponding functional requirements. The bonding method of the electrodes 3122 to the insulating substrate 3121 is not limited; for example, they may be bonded to the insulating substrate 3121 by means of bonding, etching, plating, etc. The electrodes 3122 have exposed discharge surfaces and can form an electric field during use. In this application, the number, shape, size, and distribution position of the electrodes 3122 on a single spline 310 are not limited, and those skilled in the art can design them as needed. In some embodiments, the flexible circuit board 312 may also include a cover layer, the material of which may be the same as that of the insulating substrate 3121, and which may be bonded to the insulating substrate 3121 by means of bonding, hot pressing or other methods, thereby providing protection for the circuit on the insulating substrate 3121.
[0059] The flexible circuit board 312 is fixed to the elastic sheet 311 and bends and deforms with the elastic sheet 311. The flexible circuit board 312 and the elastic sheet 311 can be directly fixed or indirectly fixed through other structures, such as a main heat shrink tubing 316 (described below) between them, and both can be fixed to the main heat shrink tubing 316. The fixing method between the flexible circuit board 312 and the elastic sheet 311 is not limited. For example, in some embodiments, it can be fixed by adhesive, and the adhesive can be polyurethane glue, UV glue, epoxy resin, acrylic resin, etc.; in other embodiments, the flexible circuit board 312 can also be fixed to the elastic sheet 311 or the main heat shrink tubing 316 by heat pressing. Those skilled in the art will understand that the hot-pressing process, referencing existing processes in related technologies, can soften and flow the adhesive or coating between the material to be fixed (e.g., flexible circuit board 312) and the substrate (e.g., elastic sheet 311) by applying a certain temperature and pressure, filling the tiny gaps between them, thereby creating a tight contact and bond. Considering that this is not directly related to the innovative content and technical problem to be solved in this application, it will not be elaborated further here. Using hot pressing is beneficial for achieving strong bonding strength and high production efficiency.
[0060] Referring to Figure 6, to avoid excessive stress when the distal end of the spline 310 bends, the flexible circuit board 312 has an extension portion 3123 that extends beyond the distal end of the elastic sheet 311. The spline 310 also includes a flexible reinforcement 314, which is disposed along the spline 310. The flexible reinforcement 314 has a fixed portion 3141 and an extension portion 3142. The fixed portion 3141 is connected to the elastic sheet 311 and can deform synchronously with the elastic sheet 311. The extension portion 3142 extends beyond the distal end of the elastic sheet 311 and is stacked with the flexible circuit board 312 having the extension portion 3123. Meanwhile, the spline 310 also includes a distal heat shrink tubing 315, which comprises a first part and a second part. The first part wraps around the overlapping section of the flexible circuit board 312 and the elastic sheet 311. The second part wraps around the extension portion 3142 of the flexible reinforcement 314 and the extended portion 3123 of the flexible circuit board 312. The extension portion 3142, the extended portion 3123, and the distal heat shrink tubing 315 form a distal bending portion 313 at the distal end of the spline 310. The distal bending portion 313 is used to bend when the basket electrode assembly 300 expands and contracts. The flexible circuit board 312, the flexible reinforcement 314, and the distal heat shrink tubing 315 of the distal bending portion 313 are all relatively easy to bend and deform, thus easily meeting the bending requirements at the distal end of the spline 310, avoiding excessive stress during bending, and also improving the safety of the basket-shaped conduit.
[0061] It should be noted that those skilled in the art will understand that heat shrink tubing can shrink when heated, thereby wrapping around the object inside the tubing and compressing it. The heat shrink tubing can be made of any available material in the relevant field, such as polyester (PET). However, since the basket-like catheter needs to be inserted into the patient's body, biocompatibility can also be considered when selecting the material.
[0062] In some embodiments, the proximal end of the distal heat shrink tubing 315 is located on the portion of the distal end of the flexible circuit board 312 where the electrode 3122 is not provided, which can strengthen the connection between the flexible circuit board 312 and the elastic sheet 311, and also prevent the spline 310 from being too thick and wide.
[0063] The aforementioned flexible reinforcing member 314 can be a flexible rope. The flexible reinforcing member 314 can protect the distal end of the spline 310, which is beneficial to improving the reliability and service life of the bending structure of the spline 310. Simultaneously, the fixed portion 3141 of the flexible reinforcing member 314 can be fixedly connected to the elastic sheet 311, enabling structural connection and force transmission between the extended portion 3142 of the flexible reinforcing member 314 and the extended portion 3123 of the flexible circuit board 312 and the elastic sheet 311. In some embodiments, the proximal end of the flexible reinforcing member 314 is located at the proximal end of the elastic sheet 311, which can structurally strengthen the elastic sheet 311, thus improving the overall structural stability of the basket electrode assembly 300 and increasing the bending fatigue strength of the elastic sheet 311.
[0064] The flexible reinforcement 314 arranged along the spline 310 can take various forms, such as being made of high-molecular-weight polyethylene fiber, polyester fiber, nylon fiber, or aramid fiber, and having a side-by-side structure, a cross-laminated structure, or other woven structures. The flexible reinforcement 314 and the flexible circuit board 312 can be tightly bonded together by the wrapping of the distal heat-shrink tubing 315, or they can be directly fixed, for example, by adhesive bonding or heat pressing. For example, when using adhesive bonding, the adhesive can be epoxy resin, ethyl cyanoacrylate, acrylic resin, ethyl acetate, etc. The coverage width of the flexible reinforcement 314 can be equal to the width of the elastic sheet 311, which is beneficial for providing stable support to the flexible circuit board 312. In some other embodiments, the coverage width of the flexible reinforcement 314 can also be less than or greater than the width of the elastic sheet 311.
[0065] The surface of the elastic sheet 311 facing the flexible circuit board 312 can be bonded or heat-pressed to the flexible reinforcement 314. In one specific embodiment, the flexible reinforcement 314 can be pre-fixed to the surface of the elastic sheet 311, then the main heat shrink tubing 316 is fitted on (as shown in Figures 6 and 7), and then heat-pressed to bond the flexible reinforcement 314 to the elastic sheet 311, ensuring reliable connection between the main heat shrink tubing 316 and the flexible reinforcement 314 and the elastic sheet 311. Pre-fixation can be achieved by applying adhesive to the strip-shaped elastic sheet 311 and bonding the flexible reinforcement 314 to the surface of the elastic sheet 311 with the adhesive. The adhesive can be, for example, PU adhesive or epoxy resin adhesive.
[0066] When the elastic sheet 311 is in a bent shape in its free state, the flexible circuit board 312 is less likely to be reliably connected to the elastic sheet 311 compared to a planar elastic sheet 311. Therefore, in some embodiments, the spline 310 further includes a main heat-shrink tubing 316, which wraps around the overlapping section of the elastic sheet 311 and the flexible reinforcement 314. At least a portion of the flexible circuit board 312 is fixed to the main heat-shrink tubing 316. The proximal end of the main heat-shrink tubing 316 can be located near the proximal end of the elastic sheet 311. In this case, the flexible circuit board 312 can be completely fixed to the main heat-shrink tubing 316, which is more conducive to the connection of the flexible circuit board 312 and avoids the formation of steps on the surface of the flexible circuit board 312 due to partial absence of the main heat-shrink tubing 316. The material of the main heat-shrink tubing 316 can be the same as that of the distal heat-shrink tubing 315, which will not be described further here.
[0067] In some embodiments, the distal end of the distal heat shrink tubing 315 extends to the end of the extension portion 3142 of the flexible reinforcement 314 and the end of the extended portion 3123 of the flexible circuit board 312. For example, the distal ends of the distal heat shrink tubing 315, the aforementioned extension portion 3142 and the extended portion 3123 can be flush, or although they are not flush, they all extend into the distal fixing seat 330, which is beneficial to forming a more stable and reliable connection structure.
[0068] Referring to Figure 4, in some embodiments, the distal end of the elastic sheet 311 includes a distal tapered section 3112, the width of which gradually narrows toward the distal end of the elastic sheet 311; and / or, the proximal end of the elastic sheet 311 is provided with a proximal tapered section, the width of which gradually narrows toward the proximal end of the elastic sheet 311. Using the above-mentioned width-gradient structure is beneficial for improving the bending and deformation flexibility of the spline 310.
[0069] In some embodiments, the elastic sheet 311 may include a bent portion 3113 and a straight portion 3114 connected to the proximal end of the bent portion 3113, with a bend formed between the straight portion 3114 and the bent portion 3113; the distal end of the bent portion 3113 is located at the extension line of the straight portion 3114. To make the basket electrode assembly 300 spherical in its free state, the bent portion may be arc-shaped, and the straight portion 3114 allows the proximal end of the spline 310 to extend axially along the proximal connector, thereby making it easier for the basket electrode assembly 300 and the proximal connector to form a coaxial structure. Those skilled in the art will understand that, to make the elastic sheet 311 have a specific shape in its free state, the transformation temperature of the shape memory alloy can be utilized to give the elastic sheet 311 a corresponding shape and avoid stress residue caused by direct bending.
[0070] The proximal retainer 320 of the basket electrode assembly 300 provides a proximal fixed connection for the spline 310. During the manufacture of the basket-shaped conduit, the proximal retainer 320 can be fixed to the tube body 200 of the basket-shaped conduit, thereby connecting the basket electrode assembly 300 to the tube body 200. In some embodiments, the proximal retainer 320 can be a section of tube, and the proximal end of the spline 310 can be fixed to the inner wall of the tube body. Those skilled in the art will understand that in some other embodiments, the proximal retainer 320 can be replaced with other structures, not limited to a hollow tube body, as long as it meets the fixing requirements of the proximal end of the spline 310 and other requirements of the basket-shaped conduit.
[0071] The distal end fixing seat 330 of the basket electrode assembly 300 provides a fixed connection for the distal end of the spline 310. For example, as shown in Figure 5, the distal end of the spline 310 can be bent and inserted into the mounting cavity 331 of the proximal end fixing seat 320 for fixation. The distal end fixing seat 330 is movable relative to the proximal end fixing seat 320 along the proximal-distal direction of the basket electrode assembly 300, while the spline 310 is deformable. In some embodiments, the distal end fixing seat 330 can fix the distal ends of the independent splines 310 together, so that the basket electrode assembly 300 has a controllable shape.
[0072] When the spline 310 adopts the above-described independent structure, the reliability of the connection between the spline 310 and the distal fixing seat 330 is an important factor affecting the reliable operation of the basket electrode assembly 300. In some embodiments, the distal bending portion 313 of the spline 310 includes a bent portion 3131 located at the farthest end of the spline 310, and a connecting portion 3132 located between the bent portion 3131 and the elastic sheet 311 (see FIG. 5). The bent portion 3131 extends along the proximal-distal direction of the basket electrode assembly 300. The distal fixing seat 330 is provided with a mounting cavity 331, which forms an opening on the distal end face of the distal fixing seat 330. The bent portion 3131 is fixed in the mounting cavity 331. The method of fixing the bent portion 3131 in the mounting cavity 331 of the distal fixing seat 330 is not limited. For example, it can be bonding, potting, or it can be pressed against the cavity wall of the mounting cavity 331 by a plug inserted into the mounting cavity 331 (for example, it can be part of the end cap 340). The force direction between the bent portion 3131 and the distal fixing seat 330 is different from the force direction of the connecting portion 3132 during the expansion and retraction of the basket electrode assembly, which helps to prevent the distal end of the spline 310 from detaching from the distal fixing seat 330.
[0073] In addition, the distribution position of splines 310 in the circumferential direction of the basket electrode assembly 300 will affect the distribution of electrodes 3122 and electric field. Therefore, in some embodiments, positioning grooves 333 can be provided on the distal end face of the distal fixing seat 330. The positioning grooves 333 are distributed at intervals along the circumferential direction of the basket electrode assembly, and the distal bent portion 313 of each spline 310 is respectively embedded in the corresponding positioning groove 333 to be positioned along the circumferential direction of the basket electrode assembly 300.
[0074] For basket-shaped catheters, it is necessary to determine the position of the basket electrode assembly 300 within the patient's body and / or to perform some probing within the patient's body during use. Therefore, in some embodiments, the basket electrode assembly 300 may also include functional components 350 disposed on the distal fixation base 330. These functional components 350 may be electronic components, such as magnetic field-based position sensors, which can sense information such as the spatial position and / or angle of the basket electrode assembly 300. In some other embodiments, the functional components 350 may also be other components, such as an ultrasound module, a ranging module, a visual imaging module, a pressure sensor, etc. The ultrasound module is used to perform ultrasound detection on the target tissue, the ranging module is used to detect the distance between the distal end of the basket electrode assembly 300 and the target tissue, the visual imaging module is used to image the surrounding environment of the distal end of the basket electrode assembly 300, and the pressure sensor is used to detect the adhesion force between the basket electrode assembly 300 and the target tissue.
[0075] The distal mounting base 330 can be a rotating structure, facilitating manufacturing and ensuring the uniformity of the basket electrode assembly 300 in all directions. To facilitate the installation of the functional component 350, in some embodiments, referring to Figures 5 and 6, the distal mounting base 330 has a mounting cavity 331. The mounting cavity 331 forms an opening on the distal mounting base 330 for the installation of the functional component 350. For example, an opening is formed on the distal end face of the distal mounting base 330, and the functional component 350 can be fixed within the mounting cavity 331. The basket electrode assembly 300 may also include an end cap 340, which can be fixed to the distal opening of the distal mounting base 330, for example, by adhesive bonding, snap-fit fixing, welding, or other methods. The annular end face of the proximal end of the end cap 340 can position the distal ends of each spline 310 along the proximal-distal direction, further ensuring the uniformity of the position of each spline 310. In addition, the outer diameter of the end cap 340 can be consistent with the outer diameter of the distal end face of the distal fixing seat 330, which is conducive to the smooth entry and exit of the basket electrode assembly 300 into and out of the sheath.
[0076] In some other embodiments, the opening for receiving the functional component 350 may also be provided at other locations of the distal retainer 330, such as the proximal end face or the outer peripheral face. In addition, the functional component 350 may also be provided on the outside of the distal retainer 330.
[0077] For the basket electrode assembly 300 with functional component 350, since functional component 350 often needs to be connected to lead wires, and the basket electrode assembly 300 is a self-expanding structure, the tube body 200 of the basket-shaped conduit does not have a drive rod for driving the distal fixing seat 330 to move. Therefore, the lead wire cannot be led out from the drive rod. In order to facilitate the free extension of the lead wire of functional component 350 when the basket-shaped conduit expands and retracts, in some cases, the lead wire is often led out through spline 310. However, in this case, the lead wire needs to be fixed on spline 310, which increases the manufacturing difficulty of spline 310 and basket electrode assembly 300.
[0078] In some embodiments, to avoid increasing the manufacturing difficulty of the spline 310 and the basket electrode assembly 300 by fixing the lead wire to the spline 310, please refer to Figures 8 to 10. The basket electrode assembly 300 also includes a base lead wire 360. The base lead wire 360 includes an elastic telescopic section 364 and a straight section 365. At least a portion of the elastic telescopic section 364 is located between the proximal fixing seat 320 and the distal fixing seat 330. The elastic telescopic section 364 is used to change its size along the proximal-distal direction according to the position change of the distal fixing seat 330, thereby avoiding setting the lead wire on the spline 310 while meeting the lead wire ... At least one of the proximal and distal ends of the elastic telescopic segment 364 may be connected to the aforementioned straight segment 365. The straight segment 365 at the proximal end of the elastic telescopic segment 364 may be connected to the proximal fixing seat 320, and the straight segment 365 at the distal end of the elastic telescopic segment 364 may be connected to the distal fixing seat 330.
[0079] In some embodiments, the distal end of the seat lead 360 is connected to the distal fixing base 330, and the seat lead 360 passes through the proximal fixing base 320. In one specific embodiment, referring to FIG10, a through channel 332 is provided on the bottom wall of the mounting cavity 331 of the distal fixing base 330, through channel 332 for the lead to pass through to connect with the functional component 350. It should be noted that although this specification defines that the distal end of the seat lead 360 is connected to the distal fixing base 330, in the case where the functional component 350 is provided, the seat lead 360 is actually ultimately connected to the functional component 350. Furthermore, the seat lead 360 can have a direct connection with the distal fixing base 330, or it can be indirectly connected to the distal fixing base 330 through the functional component 350.
[0080] The elastic telescopic function of the elastic telescopic segment 364 is achieved through its elastic telescopic structure. In some embodiments, the elastic telescopic structure of the elastic telescopic segment 364 can be a spiral structure. When the proximal and distal ends of the elastic telescopic segment 364 are stretched, the spiral structure undergoes elastic deformation, increasing the pitch. When the tension changes, the pitch changes accordingly, thereby achieving a positional change in the distal fixing seat 330. In one specific embodiment, the elastic telescopic segment 364 can be a circular spiral structure, that is, a spiral structure that appears circular when viewed along the axis of the elastic telescopic segment 364, which is relatively easy to manufacture. Those skilled in the art will understand that in some other embodiments, the elastic telescopic segment 364 can also be a spiral structure of other shapes, such as square, rectangular, or elliptical. In addition, in some other embodiments, the elastic telescopic segment 364 can also adopt other structural forms to achieve elastic telescopicity, such as a wavy zigzag structure.
[0081] In one specific embodiment, referring to Figure 10, the lead wire 360 of the base includes a sheath tube 361, an elastic skeleton 362, and a transmission line 363. The elastic skeleton 362 and the transmission line 363 pass through the cavity of the sheath tube 361. The elastic skeleton 362 is used to realize the elastic expansion and contraction of the elastic telescopic section 364. For example, the sheath tube 361 can be made of polyurethane (PU), polytetrafluoroethylene (PTFE), nylon (PA), etc. The sheath tube 361 can protect the elastic skeleton 362 and the transmission line 363, which helps to prevent the elastic skeleton 362 and the transmission line 363 from being exposed to liquid environments, such as blood, and also helps to prevent damage to the transmission line 363. Furthermore, the elastic skeleton 362 and the transmission line 363 are both disposed inside the sheath tube 361, and the sheath tube 361 and the elastic skeleton 362 are fixed to the distal fixing seat 330, which helps to prevent the transmission line 363 from being directly stressed, and the structure is relatively neat, making it less likely to interfere with the spline 310.
[0082] In some embodiments, the inner diameter of the sheath 361 may be larger than the inner diameter of the elastic skeleton 362, and the gap formed between the sheath 361 and the elastic skeleton 362 facilitates the arrangement of the transmission line 363. The arrangement of the transmission line 363 within the sheath 361 is not limited; for example, it may be arranged side-by-side with the elastic skeleton 362 or wound around the elastic skeleton 362. In some embodiments, the outer contour of the cross-section of the base lead-out line 360 may be circular. For the base lead-out line 360 with the sheath 361, the cross-section of the sheath 361 may be circular.
[0083] The aforementioned elastic frame 362 can be made of metal or non-metal, such as stainless steel or nickel-titanium alloy. The aforementioned transmission line 363 can be enameled wire or an insulated conductor.
[0084] It should be noted that in some other embodiments, the specific structure of the elastic telescopic section 364 of the base lead 360 can also be replaced with other forms. For example, referring to Figures 11 to 12, the transmission line 363 itself can be made into an elastic telescopic structure; or, the above-mentioned sheath tube 361 can be omitted.
[0085] To facilitate the connection between the sheath tube 361 and the elastic skeleton 362 and the distal fixing seat 330, in some embodiments, the through channel 332 on the distal fixing seat 330 for the lead wire of the functional component 350 to pass through is a stepped hole structure, including a first stepped section 3321 and a second stepped section 3322 arranged sequentially from the proximal end to the distal end of the distal fixing seat 330. The inner diameters of the first stepped section 3321 and the second stepped section 3322 gradually decrease. The first stepped section 3321 is used for the distal end of the sheath tube 361 to be inserted and fixed, and the second stepped section 3322 is used for the straight portion 3114 of the distal end of the elastic skeleton 362 to be inserted and fixed. The connection method between the sheath tube 361 and the elastic skeleton 362 and the distal fixing seat 330 is not limited, for example, it can be adhesive bonding, interference fit, or welding. The first step 3321 and the second step 3322 are provided to ensure the reliability of the connection between the sheath tube 361 and the elastic skeleton 362 and the distal fixing seat 330. In some other embodiments, the sheath tube 361 and the elastic skeleton 362 can also be fixed to the distal fixing seat 330 in other ways, such as by mating to the proximal end face of the distal fixing seat 330.
[0086] For the self-expanding basket electrode assembly 300, the basket electrode assembly 300 is in an expanded state in its free state. When it enters the sheath, it is compressed and contracts, and the distal fixing seat 330 moves towards the distal end of the basket electrode assembly 300. To avoid the elastic telescopic section 364 affecting the expanded state of the basket electrode assembly 300 in its free state, in some embodiments, when the basket electrode assembly 300 is in its expanded state, the elastic telescopic section 364 is in a free state, that is, the axial dimension of the elastic telescopic section 364 is its original dimension. This arrangement of the elastic telescopic section 364 can avoid affecting the expanded state of the basket electrode assembly 300, allowing for greater freedom of movement of the entire basket at the head end. In some other embodiments, when the basket electrode assembly 300 is in its expanded state, the elastic telescopic section 364 may also have an elastic deformation.
[0087] The lead wire 360 is disposed within the internal space of the basket electrode assembly 300 and passes through the proximal fixing seat 320, thus allowing direct access to the tube body 200. In one specific embodiment, the portion of the lead wire 360 passing through the proximal fixing seat 320 can be fixedly connected to the proximal fixing seat 320. This helps ensure the consistency of the movement of the elastic telescopic section 364, thereby avoiding any impact on the shape of the basket electrode assembly 300 in its expanded state. The method of fixing the lead wire 360 to the proximal fixing seat 320 is not limited. For example, glue can be injected into the proximal fixing seat 320, and after the glue cures, the lead wire 360 can be fixed to the proximal fixing seat 320. In some other embodiments, the lead wire 360 can also be fixed to the tube body 200 or to a circuit board inside the operating handle 100. In some embodiments, the sheath tube 361 and the elastic skeleton 362 may be located only between the proximal fixation seat 320 and the distal fixation seat 330, which helps to avoid occupying space within the tube body 200, thereby enabling the tube body 200 to achieve a smaller outer diameter.
[0088] As the basket electrode assembly 300 is pulled into the sheath by the tube body 200, it is radially compressed and retracts. The distal fixing seat 330 moves towards the distal end of the basket electrode assembly 300 relative to the proximal fixing seat 320. Simultaneously, the distal end of the elastic telescopic section 364 is pulled towards the distal end of the basket electrode assembly 300 by the distal fixing seat 330, and the elastic telescopic section 364 undergoes elastic tensile deformation. As the basket electrode assembly 300 is pushed out of the sheath by the tube body 200, it gradually and automatically expands into an expanded state. Under the action of the rebound force of the elastic telescopic section 364 and the spline 310, the distal fixing seat 330 moves towards the proximal end of the basket electrode assembly 300. The elastic telescopic section 364, through its own elongation and retraction, can adapt to the positional changes of the distal fixing seat 330 relative to the proximal fixing seat 320 and ensure the conductivity of the lead wire.
[0089] It should be noted that the basket-shaped catheter in the embodiments of this application can be an ablation catheter used to ablate the target tissue, such as pulsed electric field ablation (PFA) or radiofrequency ablation (RF); in addition, in some other embodiments, the basket-shaped catheter in the embodiments of this application can be a mapping catheter used to collect electrophysiological signals of the target tissue.
[0090] In some other embodiments, the base lead 360 can be a conductive wire or a fluid conduit. When the base lead 360 is a conductive wire, it can be used to lead out the conductor of the electrode 3122 on the spline 310, regardless of whether the functional component 350 is provided.
[0091] An embodiment of the spline manufacturing method of the basket-shaped conduit in this application:
[0092] The method for manufacturing the spline of a basket-shaped conduit may include the following steps:
[0093] Step 1: A flexible reinforcing member 314 is provided on the strip-shaped elastic sheet 311. The flexible reinforcing member 314 is provided along the spline 310. The flexible reinforcing member 314 has a fixed portion 3141 connected to the elastic sheet 311 and an extension portion 3142 extending out of the distal end of the elastic sheet 311.
[0094] The fixed portion 3141 of the flexible reinforcement 314 can be the same length as the elastic sheet 311 or shorter than the length of the elastic sheet 311.
[0095] Step 2: Fix the flexible circuit board 312 to the side of the elastic sheet 311 that protrudes outward when in use. The flexible circuit board 312 includes an electrode 3122 for transmitting electrical energy. The flexible circuit board 312 has an extension portion 3123 that extends outward from the far end of the elastic sheet 311 and is stacked with the extension portion 3142 of the flexible reinforcement 314.
[0096] Step 3: Apply the distal heat shrink tubing 315, so that the first part of the distal heat shrink tubing 315 wraps the overlapping section of the flexible circuit board 312 and the elastic sheet 311, and the second part wraps the extension portion 3142 of the flexible reinforcement 314 and the extended portion 3123 of the flexible circuit board 312. Heat the distal heat shrink tubing 315 so that the first part shrinks and hugs the overlapping section, and the second part shrinks and hugs the extension portion 3142 and the extended portion 3123. A distal bending portion 313 is formed at the distal end of the spline 310. The distal bending portion 313 is used to bend when the basket electrode assembly 300 expands and contracts.
[0097] In some embodiments, the steps prior to step two include: putting on the aforementioned main heat shrink tube 316, the main heat shrink tube 316 wrapping the overlapping section of the elastic sheet 311 and the flexible reinforcement 314; heating the main heat shrink tube 316 to shrink it and tightly hold the overlapping section of the elastic sheet 311 and the flexible reinforcement 314.
[0098] In some embodiments, the flexible circuit board 312 can be hot-pressed onto the main heat shrink tube 316 by a curved clamp. The curved clamp has a support surface adapted to the bending shape of the strip-shaped elastic sheet 311. The elastic sheet 311, which is fitted with the main heat shrink tube 315, can fit into the support surface of the curved clamp. At this time, hot pressing can keep the elastic sheet 311 in its set free bending shape.
[0099] In some embodiments, in step one, the flexible reinforcement 314 is pre-fixed to the surface of the elastic sheet 311 by dispensing adhesive; after the main body heat shrink tube 316 is put on, hot pressing is performed so that the flexible reinforcement 314 is fixed to the elastic sheet 311 by hot pressing.
[0100] In some embodiments, in step three, placing the proximal end of the distal heat shrink tubing 315 on the portion of the distal end of the flexible circuit board 312 where the electrode 3122 is not located can avoid obstructing the electrode 3122, thereby ensuring electrical conduction between the spline 310 and the surrounding target tissue.
[0101] The elastic sheet 311, flexible circuit board 312, flexible reinforcement 314 and distal heat shrink tubing 315 mentioned above can be referred to the embodiment of the basket electrode assembly 300 described above, and will not be repeated here.
[0102] Embodiments of the net basket electrode assembly in this application:
[0103] The basket electrode assembly can be the basket electrode assembly 300 in any of the above-described basket-shaped conduits, including a spline 310, a proximal fixation seat 320, a distal fixation seat 330, and a seat lead wire 360. The specific structure will not be described again here.
[0104] The above examples illustrate this application only to aid understanding and are not intended to limit its scope. Those skilled in the art to which this application pertains can make various simple deductions, modifications, or substitutions based on the ideas presented.
Claims
1. The spline of a basket-like vascular bundle, characterized in that, include: A strip-shaped elastic sheet; A flexible reinforcement member is provided along the spline, the flexible reinforcement member has a fixed portion and an extended portion, the fixed portion is connected to the elastic sheet, and the extended portion extends beyond the distal end of the elastic sheet; A flexible circuit board, the flexible circuit board being fixed to the elastic sheet, the flexible circuit board including electrodes for transmitting electrical energy; The flexible circuit board has an extended portion that extends beyond the distal end of the elastic sheet and is stacked with an extended portion of the flexible reinforcement. And a distal heat shrink tubing, a portion of which wraps around the overlapping section of the flexible circuit board and the elastic sheet, and another portion of which wraps around the extension of the flexible reinforcement and the extended portion of the flexible circuit board, thereby forming a distal bend at the distal end of the spline, the distal bend being used to bend when the basket electrode assembly expands and contracts.
2. The spline as described in claim 1, characterized in that, The elastic sheet is bent in the free state, so that the basket-shaped conduit is expanded in the free state.
3. The spline as described in claim 1 or 2, characterized in that, The distal end of the distal heat shrink tubing extends to the ends of the extension portion and the outward portion.
4. The spline as described in claim 1 or 2, characterized in that, The proximal end of the distal heat shrink tubing is located on the portion of the distal end of the flexible circuit board where the electrode is not located.
5. The spline as described in claim 1 or 2, characterized in that, It includes a main heat shrink tubing that wraps around the overlapping section of the elastic sheet and the flexible reinforcement, and at least a portion of the flexible circuit board is fixed to the main heat shrink tubing.
6. The spline as described in claim 5, characterized in that, The proximal ends of the flexible reinforcement and the main heat shrink tubing are both located near the proximal end of the elastic sheet.
7. The spline as described in claim 1 or 2, characterized in that, The distal end of the elastic sheet includes a distal gradient segment, the width of which gradually narrows toward the distal end of the elastic sheet; and / or, the proximal end of the elastic sheet is provided with a proximal gradient segment, the width of which gradually narrows toward the proximal end of the elastic sheet.
8. The spline as described in claim 1 or 2, characterized in that, The elastic sheet includes a curved portion and a straight portion connected to the proximal end of the curved portion, wherein the straight portion and the curved portion form a bend; the distal end of the curved portion is located at the extension of the straight portion.
9. The spline as described in claim 8, characterized in that, The curved portion is arc-shaped, used to make the expanded shape of the electrode assembly of the basket-shaped conduit spherical.
10. The spline as described in claim 1 or 2, characterized in that, The elastic sheet is bonded or heat-pressed to the surface of the flexible circuit board facing the flexible reinforcing member.
11. The spline as described in claim 1 or 2, characterized in that, The coverage width of the flexible reinforcement is equal to or less than the width of the elastic sheet.
12. The spline as described in claim 1 or 2, characterized in that, The flexible reinforcement is a flexible rope.
13. A basket electrode assembly, characterized in that, include: Splines, wherein the splines are any of claims 1 to 12, and the splines are distributed circumferentially along the basket electrode assembly; A proximal fixing seat is fixedly connected to the proximal end of each spline; And a remote fixing seat, wherein the remote fixing seat is fixedly connected to the remote curved portion of the distal end of each spline.
14. The basket electrode assembly as described in claim 13, characterized in that, The distal bending portion includes a bent portion located at the farthest end of the spline, and a connecting portion located between the bent portion and the elastic sheet. The bent portion extends along the proximal-distal direction of the basket electrode assembly. The distal end face of the distal fixing seat is provided with a mounting cavity, and the bent portion is fixed in the mounting cavity.
15. The basket electrode assembly as described in claim 13, characterized in that, The distal end face of the distal fixing seat is provided with positioning grooves, which are distributed at intervals along the circumference of the basket electrode assembly. The distal curved portion of each spline is embedded in the corresponding positioning groove to be positioned along the circumference of the basket electrode assembly.
16. The basket electrode assembly as claimed in claim 13, characterized in that, The assembly includes a base lead wire, the distal end of which is connected to the distal fixing seat, and the base lead wire passes through the proximal fixing seat. The base lead wire includes an elastic telescopic section, at least a portion of which is located between the proximal fixing seat and the distal fixing seat. The elastic telescopic section is used to change its size along the proximal-distal direction of the basket electrode assembly as the position of the distal fixing seat changes.
17. The basket electrode assembly as claimed in claim 16, characterized in that, The elastic expansion segment has a spiral structure.
18. The basket electrode assembly as claimed in claim 16, characterized in that, The lead wire of the seat includes a sheath tube, an elastic skeleton and a transmission line. The elastic skeleton and the transmission line are inserted into the cavity of the sheath tube. The elastic skeleton is used to realize the elastic expansion and contraction of the elastic expansion section. The sheath tube and the elastic skeleton are fixed to the distal fixing seat.
19. The basket electrode assembly as claimed in claim 16, characterized in that, When the basket electrode assembly is in an expanded state, the elastic telescopic section is in a free state.
20. A method for manufacturing the spline of a basket-shaped duct, characterized in that, Includes the following steps: Step 1: A flexible reinforcement is provided on the strip-shaped elastic sheet. The flexible reinforcement is provided along the spline and has a fixed portion connected to the elastic sheet and an extended portion extending beyond the distal end of the elastic sheet. Step 2: Fix the flexible circuit board onto the elastic sheet. The flexible circuit board includes electrodes for transmitting electrical energy. The flexible circuit board has an extended portion that extends beyond the distal end of the elastic sheet and is stacked with the extended portion of the flexible reinforcement. Step 3: Apply the distal heat shrink tubing, so that the first part of the distal heat shrink tubing wraps around the overlapping section of the flexible circuit board and the elastic sheet, and the second part wraps around the extended portion of the flexible reinforcement and the extended portion of the flexible circuit board. Heat the distal heat shrink tubing so that the first part shrinks and hugs the overlapping section, and the second part shrinks and hugs the extended portion and the extended portion, forming a distal bend at the distal end of the spline. The distal bend is used to bend when the basket electrode assembly expands and contracts.
21. The spline manufacturing method as described in claim 20, characterized in that, Before step two, the method further includes the following steps: putting on the main heat shrink tubing, which wraps around the overlapping section of the elastic sheet and the flexible reinforcement; heating the main heat shrink tubing to shrink it and tightly hold the overlapping section of the elastic sheet and the flexible reinforcement.
22. The spline manufacturing method as described in claim 21, characterized in that, The flexible circuit board is hot-pressed onto the main heat-shrink tubing using a curved clamp, the curved clamp having a support surface adapted to the bending shape of the elastic sheet.
23. The spline manufacturing method as described in claim 21, characterized in that, In step one, glue is applied to the strip-shaped elastic sheet, and the flexible reinforcement is pre-fixed to the surface of the elastic sheet by the glue; after the main heat shrink tube is put on, heat pressing is performed so that the flexible reinforcement is fixed to the elastic sheet by heat pressing.
24. The spline manufacturing method according to any one of claims 20 to 23, characterized in that, In step three, the proximal end of the distal heat shrink tubing is positioned on the distal portion of the flexible circuit board where the electrode is not located.