[go: up one dir, main page]

WO2026000367A1 - Basket assembly and basket catheter - Google Patents

Basket assembly and basket catheter

Info

Publication number
WO2026000367A1
WO2026000367A1 PCT/CN2024/102560 CN2024102560W WO2026000367A1 WO 2026000367 A1 WO2026000367 A1 WO 2026000367A1 CN 2024102560 W CN2024102560 W CN 2024102560W WO 2026000367 A1 WO2026000367 A1 WO 2026000367A1
Authority
WO
WIPO (PCT)
Prior art keywords
connector
distal
basket assembly
proximal
support frame
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/CN2024/102560
Other languages
French (fr)
Chinese (zh)
Inventor
张媛
谢宇
冯君
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Enchannel Medical Guangzhou Inc
Original Assignee
Enchannel Medical Guangzhou Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Enchannel Medical Guangzhou Inc filed Critical Enchannel Medical Guangzhou Inc
Priority to PCT/CN2024/102560 priority Critical patent/WO2026000367A1/en
Publication of WO2026000367A1 publication Critical patent/WO2026000367A1/en
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Definitions

  • This invention relates to the field of electrophysiological catheters, and more specifically to basket catheters and basket components of basket catheters.
  • Electrophysiology catheters can be used for cardiac electrophysiological mapping and cardiac ablation.
  • the diagnosis of arrhythmias often relies on high-density contact mapping techniques.
  • high-density contact mapping techniques During mapping, it is crucial to ensure good electrode contact with cardiac tissue to guarantee accuracy.
  • basket catheters i.e., mapping catheters with a basket structure, are frequently used because this structure can accommodate more electrodes.
  • the basket assembly of the basket catheter may include a distal connector, a proximal connector, and a spline connecting the distal connector and the proximal connector.
  • the spline may be made of materials such as nickel-titanium alloy, which has good elasticity. Electrodes may be set on the spline to achieve mapping and/or ablation.
  • the spline needs to have a certain stiffness.
  • the stiffness of the spline will limit the flexibility of the basket assembly, affect the deformation of the basket assembly, and make it difficult for the basket assembly to adhere well to the target biological tissue.
  • the present invention mainly solves the technical problem that the basket assembly is not easy to adhere well to the target biological tissue.
  • the present invention provides a basket assembly.
  • the basket assembly includes a near-end connector, a far-end connector, and a spline
  • the proximal connector is used for fixed connection of the proximal end of the spline
  • the distal connector is used for fixed connection of the distal end of the spline
  • the spline As the distal connector approaches and moves away from the proximal connector, the spline has a retracted state and an open state.
  • the spline includes:
  • a support frame wherein the support frame is elastic
  • a flexible connector is attached to the support frame.
  • the flexible connector includes an extended portion and a folded portion.
  • the extended portion protrudes from the distal end of the support frame.
  • the folded portion is connected to the extended portion and folded towards the proximal end of the basket assembly.
  • the folded portion is fixed to the distal end connector.
  • the flexible connector includes an arc-shaped bend portion connecting the extended portion and the reverse bend portion, the arc-shaped bend portion forming a "U" shape with the extended portion and the reverse bend portion, the opening of the "U" shape facing the proximal end of the basket assembly.
  • the arc-shaped bend protrudes beyond the distal end face of the distal connector, or the distal end of the arc-shaped bend is flush with the distal end face of the distal connector.
  • a flexible circuit board is included, the flexible circuit board including an insulating substrate and electrodes, and the flexible connector is formed from the flexible circuit board.
  • the flexible circuit board has an inner side surface, which is the side of the flexible circuit board near the line connecting the proximal connector and the distal connector, and a flexible reinforcing layer is provided on the inner side surface.
  • the flexible circuit board has an inner side surface, which is the side of the flexible circuit board near the line connecting the proximal connector and the distal connector, and the support frame is disposed on the inner side surface of the flexible circuit board.
  • a retaining ring is included, which is sleeved on the outside of the distal connector.
  • the folded portion has a fixing segment, which is disposed between the retaining ring and the outer peripheral surface of the distal connector.
  • a curing colloid is included, at least a portion of which is located on the distal side of the fixing ring, the curing colloid being elastic; the flexible connector has a transition section located on the distal side of the fixing section, the curing colloid fixing the transition section to the distal connector.
  • the proximal end of the support frame is parallel to the line connecting the proximal connector and the distal connector, the proximal end of the support frame is fixed to the proximal connector, and when the spline is in the retracted state, the folded portion is parallel to the support frame.
  • the present invention provides a basket guide tube.
  • Net basket conduit including:
  • An insertion tube is connected to the distal end of the handle
  • a basket assembly wherein the basket assembly is any one of the basket assemblies described above, and the basket assembly is connected to the distal end of the insertion tube;
  • a pull rod which is movably disposed in the insertion tube and is connected to the distal connector of the basket assembly to drive the distal connector toward and away from the proximal connector.
  • a spline is connected between a distal connector and a proximal connector.
  • the elastic support frame allows the spline to have a retracted and open state.
  • the spline includes a flexible connector.
  • the extended portion of the flexible connector, protruding from the distal end of the support frame, is connected to a folded portion, which is fixed to the distal connector. This folded portion allows the distal portion of the spline to flexibly deflect circumferentially along the basket assembly, move radially along the basket assembly, or undergo a certain degree of torsional deformation through its own deformation. This provides good self-adaptability when the basket assembly is in contact with the target biological tissue, making it easier to adhere to the target biological tissue.
  • the flexible deformation of the folded part can prevent the basket assembly from making hard contact with the organism, which helps to avoid scratching the organism, improves safety, and also helps to prevent the spline from breaking due to excessive stress.
  • Figure 1 is a schematic diagram of an embodiment of the basket assembly of the present invention in the fully open state
  • Figure 2 is a magnified view of the spline area in Figure 1;
  • Figure 3 is a cross-sectional view of the connection between the spline and the distal connector in Figure 2;
  • Figure 4 is a perspective view of the connection between the spline and the distal connector in Figure 2;
  • Figure 5 is a partial three-dimensional view of the basket assembly in Figure 1 when it is in the retracted state.
  • Figure 6 is a cross-sectional view of the basket assembly in Figure 5;
  • Figure 7 is a schematic diagram of the structure of the distal part of the spline in Figure 6.
  • connection and “linkage” used in this application, unless otherwise specified, include both direct and indirect connections (linkages).
  • the spline 300 of the basket assembly is provided with a flexible connector 330.
  • the distal end of the flexible connector 330 is provided with a folded portion 333, which is fixed on the distal connector 200, forming a deformable hinge structure. This allows the spline 300 to move adaptively when subjected to the reaction force of the target biological tissue, thereby making it easier to adhere to the target biological tissue.
  • the basket assembly includes a proximal connector 100, a distal connector 200, and a spline 300.
  • the proximal connector 100 provides a proximal fixed connection for the spline 300
  • the distal connector 200 provides a distal fixed connection for the spline 300.
  • proximal and distal used in this article are conventional terms in the medical field.
  • the proximal end is the end closer to the operator, and the distal end is the end farther away from the operator.
  • the distal end is usually the end that enters the patient's body first.
  • the proximal and distal ends can be referred to the orientation shown in Figure 1.
  • the proximal connector 100 can be a section of tubing, the inner cavity of which forms a connecting cavity for the proximal insertion and fixed connection of the spline 300.
  • the specific fixing method between the spline 300 and the proximal connector 100 is not limited; for example, they can be fixedly connected by bonding, welding, or other methods.
  • the proximal connector 100 can be connected to the insertion tube of the basket conduit, allowing the basket assembly to be transported to the target location by the insertion tube.
  • the distal connector 200 is a sleeve structure.
  • a central hole in the sleeve allows a pull rod 500 to be connected, enabling the distal connector 200 to move via the pull rod 500.
  • a sensor 600 can also be installed within the central hole of the distal connector 200.
  • the sensor 600 is used for position detection of the basket assembly; for example, it can be a magnetoelectric positioning sensor.
  • the pull rod 500 can pass through the insertion tube of the basket guide tube and connect to the handle of the basket guide tube.
  • a drive button can be installed on the handle. Operating the drive button moves the pull rod 500 towards the distal or proximal end of the basket assembly, thereby driving the distal connector 200 to move towards the distal or proximal end of the basket assembly via the pull rod 500.
  • proximal connector 100 and the distal connector 200 can be replaced with other structural forms, as long as the spline 300 can be installed; the accessories connected to the proximal connector 100 and the distal connector 200 can also be set as needed.
  • specific structure of the pull rod 500 and the handle can refer to existing structures in related technologies, and 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.
  • the proximal connector 100 is fixed to the insertion tube 700, when the distal connector 200 moves towards the proximal end of the basket assembly, the distal connector 200 gradually approaches the proximal connector 100, and the basket assembly gradually opens from a retracted state until it reaches its maximum stroke, at which point the basket assembly is in a fully open state.
  • the spline 300 can smoothly bend radially outwards towards the basket assembly, as shown in Figures 1 to 4.
  • the open state of the basket assembly refers to the state in which the basket assembly can be used for electrophysiological mapping or ablation of the heart; the basket assembly can have different degrees of opening depending on the morphology and size of the target biological tissue.
  • Figures 1 to 4 only show the state when the basket assembly is fully open.
  • the structure of the spline 300 itself and the connection structure of the spline 300 between the proximal connector 100 and the distal connector 200 will affect the opening shape of the basket assembly, which will be described in detail below. It should be noted that the number of splines 300 is not limited in this invention.
  • spline 300 may include a support frame 310 and a flexible circuit board 320.
  • the support frame 310 is elastic and can be made of an elastic metal, such as a nickel-titanium alloy, which has good biocompatibility and can rebound well to its initial shape after being deformed by external force.
  • the support frame 310 can be a straight structure, allowing the spline 300 to be close to the distal connector 200 and the pull rod 500, thus minimizing the radial dimension of the basket assembly.
  • the support frame 310 can be sheet-like, facilitating the connection of the flexible circuit board 320.
  • the support frame 310 can also be replaced with other forms, such as a linear form.
  • the flexible circuit board 320 has an inner side surface, which is the side of the flexible circuit board 320 near the line connecting the proximal connector 100 and the distal connector 200.
  • the support frame 310 can be disposed on the inner side surface of the flexible circuit board 320, so that the electrodes 322 on the flexible circuit board 320 face the outer side of the basket assembly, thereby enabling them to adhere to the target biological tissue.
  • the flexible circuit board 320 can be fixed to the support frame 310 by adhesive bonding, and the adhesive can be polyurethane glue, UV glue, epoxy resin, acrylic resin, etc.
  • the proximal end of the support frame 310 can be flush with the proximal end of the spline 300, and the portion of the support frame 310 and the flexible circuit board 320 connected to the support frame 310 together form the main body of the spline.
  • the flexible circuit board 320 may include an insulating substrate 321 and electrodes 322.
  • the insulating substrate 321 may be made of polyimide (PI), polyethylene terephthalate (PET), etc.
  • the electrodes 322 may be made of platinum-iridium alloy, stainless steel alloy, copper, etc.
  • the bonding method of the electrodes 322 to the insulating substrate 321 is not limited; for example, they can be bonded to the insulating substrate 321 by means of bonding, etching, plating, etc.
  • the electrodes 322 have exposed discharge surfaces and can form an electric field during use.
  • the flexible circuit board 320 may also include a cover layer.
  • the material of the cover layer may be the same as that of the insulating substrate 321, and it can be bonded to the insulating substrate 321 by means of bonding, hot pressing, etc., providing protection for the circuit on the insulating substrate 321.
  • the length of the flexible circuit board 320 is greater than the length of the support frame 310.
  • the distal end of the flexible circuit board 320 extends beyond the distal end of the support frame 310, forming an overhang portion 331.
  • the flexible circuit board 320 includes a folded portion 333, which connects to the overhang portion 331 and folds towards the proximal end of the basket assembly. The folded portion 333 is fixed to the distal connector 200.
  • each corresponding spline 300 can be displaced relatively easily, for example, in the direction indicated by the bidirectional arrow in Figure 2, or in the radial direction corresponding to the corresponding spline 300 on the basket assembly. This can increase the compliance of the entire basket assembly, so as to fit more closely to the target biological tissue.
  • the flexible connector 330 can also prevent the spline 300 from breaking due to the tearing of the opening on the flexible circuit board 320 caused by external force, thus ensuring the reliability of the basket assembly.
  • the splines 300 of the basket cannula are arranged at intervals along the circumference.
  • the target biological tissue may enter the intervals between the splines 300.
  • the biological tissue may be easily scratched.
  • the flexible hinge formed by the extended portion 331 and the folded portion 333 can prevent hard contact between the splines 300 and the biological tissue, which helps to avoid the basket assembly scratching the biological tissue and improves the safety of the operation.
  • the flexible connector 330 may also be a separate structure independent of the flexible circuit board 320, such as a sheet structure formed of polyimide (PI), polyethylene terephthalate (PET), etc. Additionally, in some other embodiments, the proximal end of the flexible connector 330 may be directly connected to the distal end of the support frame 310.
  • PI polyimide
  • PET polyethylene terephthalate
  • the basket assembly may include a retaining ring 400, which is sleeved on the outside of the distal connector 200.
  • the folded portion 333 has a fixing section, which is the portion of the folded portion 333 located between the retaining ring 400 and the outer peripheral surface of the distal connector 200.
  • the folded portion 333 is inserted into the gap between the distal connector 200 and the retaining ring 400, and then glue is applied to bond and fix the folded portion 333 to the distal connector 200.
  • the retaining ring 400 can play an auxiliary fixing and positioning role, ensuring the uniform distribution of each spline 300.
  • the folded portion 333 can also be secured by the retaining ring 400.
  • the aforementioned fixing ring 400 can be a contrast ring, which can be used simultaneously for contrasting the tip of the basket catheter and fixing the flexible circuit board 320. This reduces the number of parts, saves space, and lowers costs.
  • the contrast ring in the ablation catheter can be made of precious metals such as platinum and iridium. Such rings are clearly visible under X-rays, allowing doctors to precisely control the catheter's position during the procedure.
  • a separate ring body can be used as the fixing ring 400, solely for fixing the folded portion 333 to the distal connector 200.
  • the folded portion 333 can be directly bonded to the outer peripheral surface of the distal connector 200 or the wall of the central hole of the distal connector 200.
  • the end of the folded portion 333 can also have an L-shaped bend, which fixes it to the end face of the distal connector 200.
  • a fixed connection area can be formed between the folded portion 333 and the distal connector 200, and there is a gap between the distal edge of the fixed connection area and the distal end of the flexible connector 330. This gap increases the flexibility of the spline 300 during the opening of the basket.
  • the fixed connection area corresponds to the fixed segment of the folded portion 333 and is distributed around the axis of the distal connector 200.
  • the flexible connector 330 includes an arc-shaped bend 332, which connects the extended portion 331 and the reverse bend 333.
  • the arc-shaped bend 332, the extended portion 331, and the reverse bend 333 form a "U" shape, with the opening of the "U" facing the proximal end of the basket assembly.
  • the bend allows for a smooth reverse bend of the flexible circuit board 320, which is more conducive to preventing breakage of the flexible circuit board 320.
  • the reverse bend 333 can also be directly folded back, forming a crease between the extended portion 331 and the reverse bend 333.
  • the arc-shaped bend 332 protrudes from the distal end face of the distal connector 200; in some other embodiments, the distal end of the arc-shaped bend 332 may also be flush with the distal end face of the distal connector 200.
  • the aforementioned protruding or flush structure increases the flexibility of the spline 300's movement and makes the distal side of the basket assembly flatter after opening, preventing the distal connector 200 from protruding from the spline 300.
  • this allows the electrode 322 to better adhere to the target biological tissue.
  • the pressure generated is also lower compared to a structure where the distal connector protrudes from the spline, thus increasing patient safety.
  • the distal end of the arc-shaped bend 332 may be closer to the proximal end of the basket assembly than the distal end face of the distal connector 200.
  • the basket assembly may further include a curable adhesive (not shown in the figure), at least a portion of which is located on the distal side of the fixing ring 400.
  • the curable adhesive is elastic.
  • the curable adhesive can be formed by curing polyurethane, epoxy resin, acrylate, or other adhesives.
  • the flexible connector 330 has a transition section located on the distal side of the fixing section, and the curable adhesive fixes the transition section to the distal connector 200. By providing the curable adhesive and the transition section, the elastic curable adhesive can deform along with the flexible connector 330, providing cushioning and protection.
  • the flexible connector 330 formed by the flexible circuit board 320 will not rub against or be cut by the fixing ring 400 during movement, which helps prevent breakage of the flexible circuit board 320 and improves the operational reliability of the basket assembly.
  • the flexible circuit board 320 includes a flexible reinforcing layer 323 disposed on the inner surface of the flexible circuit board 320.
  • the flexible reinforcing layer 323 can be polyurethane, polyimide, polyethylene fiber, polyester fiber, nylon fiber, polyester fiber, polyethylene terephthalate, etc.
  • the flexible reinforcing layer 323 can be bonded and fixed to the side of the insulating substrate 321 facing away from the electrode 322.
  • the flexible reinforcing layer 323 can be bent synchronously with the insulating substrate 321 to improve the bending fatigue strength of the flexible circuit board 320.
  • the flexible reinforcing layer 323 can have the same width as the insulating substrate 321; in some other embodiments, the width of the flexible reinforcing layer 323 can be smaller or larger than the insulating substrate 321.
  • the flexibility of the flexible reinforcing layer 323 should be greater than the flexibility of the supporting frame 310, that is, it can be deformed more easily than the supporting frame 310.
  • the flexible reinforcing layer 323 can be provided only at the location on the flexible circuit board 320 used to form the flexible connector 330, or it can be provided on the entire flexible circuit board 320.
  • the proximal end of the support frame 310 is parallel to the line connecting the proximal connector 100 and the distal connector 200.
  • the proximal end of the support frame 310 is fixed to the proximal connector 100.
  • the folded portion 333 is parallel to the support frame 310.
  • the basket assembly can form a pear-shaped structure with a larger distal diameter and a smaller proximal diameter when opened, making it easier to meet mapping or ablation requirements.
  • the folded portion 333 may also have an angle with the axis of the basket assembly.
  • the basket assembly including the aforementioned flexible connector 330 can be used for electrophysiological mapping of the heart. In some other embodiments, the basket assembly including the aforementioned flexible connector 330 can also be used for cardiac ablation, such as pulsed electric field ablation (PFA) or radiofrequency ablation (RF).
  • PFA pulsed electric field ablation
  • RF radiofrequency ablation
  • the basket guide tube includes a handle, an insertion tube, a basket assembly, and a pull rod 500.
  • the insertion tube is connected to the distal end of the handle, and the basket assembly is connected to the distal end of the insertion tube.
  • the basket assembly is any of the basket assemblies described in the above embodiments, and will not be repeated here.
  • the pull rod 500 is movably disposed in the insertion tube and is connected to the distal end connector 200 of the basket assembly to drive the distal end connector 200 closer to and further away from the proximal end connector 100.

Landscapes

  • Surgical Instruments (AREA)

Abstract

The present invention relates to the field of electrophysiological catheters, and in particular, to a basket catheter and a basket assembly of the basket catheter. Provided are a basket assembly and a basket catheter. The basket assembly comprises a proximal connecting base, a distal connecting base, and splines. The proximal connecting base is configured to be fixedly connected to proximal ends of the splines, and the distal connecting base is configured to be fixedly connected to distal ends of the splines. During processes in which the distal connecting base moves close to and away from the proximal connecting base, the splines have a closed state and an open state. The spline comprises: a support frame having elasticity; and a flexible connecting member attached to the support frame. The flexible connecting member comprises an extending portion and a reverse folding portion. The extending portion is exposed beyond a distal end of the support frame, the reverse folding portion is connected to the extending portion and folded toward a proximal end of the basket assembly, and the reverse folding portion is fixed to the distal connecting base. The present invention primarily solves the technical problem that the basket assembly is not easily attached well to the target biological tissue.

Description

网篮组件及网篮导管Net basket assembly and net basket conduit 技术领域Technical Field

本发明涉及电生理导管领域,具体涉及网篮导管及网篮导管的网篮组件。This invention relates to the field of electrophysiological catheters, and more specifically to basket catheters and basket components of basket catheters.

背景技术Background Technology

电生理导管可以用于心脏电生理的标测和心脏消融。心率失常的诊断常常需要依赖高密度接触式标测技术,标测过程中需要保证电极很好的接触心脏组织,才能保证标测的准确性。在心脏电生理的高密度标测过程中,常常使用网篮导管,即网篮结构的标测导管,这是因为网篮结构的标测导管可以承载更多的电极。Electrophysiology catheters can be used for cardiac electrophysiological mapping and cardiac ablation. The diagnosis of arrhythmias often relies on high-density contact mapping techniques. During mapping, it is crucial to ensure good electrode contact with cardiac tissue to guarantee accuracy. In high-density cardiac electrophysiological mapping, basket catheters, i.e., mapping catheters with a basket structure, are frequently used because this structure can accommodate more electrodes.

网篮导管的网篮组件可以包括远端连接座、近端连接座和连接在远端连接座与近端连接座之间的花键,花键可以采用镍钛合金等材质制成,具有较好的弹性,花键上可以设置电极以实现标测和/或消融。The basket assembly of the basket catheter may include a distal connector, a proximal connector, and a spline connecting the distal connector and the proximal connector. The spline may be made of materials such as nickel-titanium alloy, which has good elasticity. Electrodes may be set on the spline to achieve mapping and/or ablation.

为了保证每条花键上各电极分布位置的稳定性,花键需要具备一定的刚度,但是花键的刚度会限制网篮组件的柔性,影响网篮组件的变形,造成网篮组件不易良好地贴靠目标生物组织。To ensure the stability of the electrode distribution on each spline, the spline needs to have a certain stiffness. However, the stiffness of the spline will limit the flexibility of the basket assembly, affect the deformation of the basket assembly, and make it difficult for the basket assembly to adhere well to the target biological tissue.

发明内容Summary of the Invention

本发明主要解决网篮组件不易良好地贴靠目标生物组织的技术问题。The present invention mainly solves the technical problem that the basket assembly is not easy to adhere well to the target biological tissue.

第一方面,本发明提供了一种网篮组件。In a first aspect, the present invention provides a basket assembly.

网篮组件,包括近端连接座、远端连接座和花键;The basket assembly includes a near-end connector, a far-end connector, and a spline;

所述近端连接座供所述花键的近端固定连接,所述远端连接座供所述花键的远端固定连接;The proximal connector is used for fixed connection of the proximal end of the spline, and the distal connector is used for fixed connection of the distal end of the spline.

所述远端连接座在靠近和远离所述近端连接座的过程中,所述花键具有收拢状态和打开状态;As the distal connector approaches and moves away from the proximal connector, the spline has a retracted state and an open state.

所述花键包括:The spline includes:

支撑骨架,所述支撑骨架具有弹性;A support frame, wherein the support frame is elastic;

柔性连接件,所述柔性连接件附着于所述支撑骨架上,所述柔性连接件包括外伸部分和反折部分,所述外伸部分露出所述支撑骨架的远端,所述反折部分与所述外伸部分连接并折向所述网篮组件的近端,所述反折部分固定在所述远端连接座上。A flexible connector is attached to the support frame. The flexible connector includes an extended portion and a folded portion. The extended portion protrudes from the distal end of the support frame. The folded portion is connected to the extended portion and folded towards the proximal end of the basket assembly. The folded portion is fixed to the distal end connector.

一种实施例中,所述柔性连接件包括弧形弯折部分,所述弧形弯折部分连接在所述外伸部分和所述反折部分之间,所述弧形弯折部分与所述外伸部分和所述反折部分形成“U”形,所述“U”形的开口朝向所述网篮组件的近端。In one embodiment, the flexible connector includes an arc-shaped bend portion connecting the extended portion and the reverse bend portion, the arc-shaped bend portion forming a "U" shape with the extended portion and the reverse bend portion, the opening of the "U" shape facing the proximal end of the basket assembly.

一种实施例中,所述弧形弯折部分凸出所述远端连接座的远端端面,或者,所述弧形弯折部分的远端与所述远端连接座的远端端面平齐。In one embodiment, the arc-shaped bend protrudes beyond the distal end face of the distal connector, or the distal end of the arc-shaped bend is flush with the distal end face of the distal connector.

一种实施例中,包括柔性电路板,所述柔性电路板包括绝缘基体和电极,所述柔性连接件由所述柔性电路板形成。In one embodiment, a flexible circuit board is included, the flexible circuit board including an insulating substrate and electrodes, and the flexible connector is formed from the flexible circuit board.

一种实施例中,所述柔性电路板具有内侧面,所述内侧面为所述柔性电路板靠近所述近端连接座与所述远端连接座的连线的一侧,所述内侧面上设有柔性加强层。In one embodiment, the flexible circuit board has an inner side surface, which is the side of the flexible circuit board near the line connecting the proximal connector and the distal connector, and a flexible reinforcing layer is provided on the inner side surface.

一种实施例中,所述柔性电路板具有内侧面,所述内侧面为所述柔性电路板靠近所述近端连接座与所述远端连接座的连线的一侧,所述支撑骨架设置在所述柔性电路板的内侧面上。In one embodiment, the flexible circuit board has an inner side surface, which is the side of the flexible circuit board near the line connecting the proximal connector and the distal connector, and the support frame is disposed on the inner side surface of the flexible circuit board.

一种实施例中,包括固定环,所述固定环套在所述远端连接座的外侧,所述反折部分具有固定段,所述固定段设置在所述固定环与所述远端连接座的外周面之间。In one embodiment, a retaining ring is included, which is sleeved on the outside of the distal connector. The folded portion has a fixing segment, which is disposed between the retaining ring and the outer peripheral surface of the distal connector.

一种实施例中,包括固化胶体,所述固化胶体的至少一部分位于所述固定环的远端侧,所述固化胶体具有弹性;所述柔性连接件具有位于所述固定段的远端侧的过渡段,所述固化胶体将所述过渡段固定在所述远端连接座上。In one embodiment, a curing colloid is included, at least a portion of which is located on the distal side of the fixing ring, the curing colloid being elastic; the flexible connector has a transition section located on the distal side of the fixing section, the curing colloid fixing the transition section to the distal connector.

一种实施例中,所述支撑骨架的近端平行于所述近端连接座与远端连接座的连线,所述支撑骨架的近端固定在所述近端连接座上,所述花键处于收拢状态时,所述反折部分平行于所述支撑骨架。In one embodiment, the proximal end of the support frame is parallel to the line connecting the proximal connector and the distal connector, the proximal end of the support frame is fixed to the proximal connector, and when the spline is in the retracted state, the folded portion is parallel to the support frame.

第二方面,本发明提供了一种网篮导管。Secondly, the present invention provides a basket guide tube.

网篮导管,包括:Net basket conduit, including:

手柄;handle;

插入管,所述插入管连接在所述手柄的远端;An insertion tube is connected to the distal end of the handle;

网篮组件,所述网篮组件为上述任一项所述的网篮组件,所述网篮组件连接在所述插入管的远端;A basket assembly, wherein the basket assembly is any one of the basket assemblies described above, and the basket assembly is connected to the distal end of the insertion tube;

以及拉杆,所述拉杆活动设置在所述插入管中,所述拉杆与所述网篮组件的远端连接座连接以驱动所述远端连接座靠近和远离所述近端连接座。And a pull rod, which is movably disposed in the insertion tube and is connected to the distal connector of the basket assembly to drive the distal connector toward and away from the proximal connector.

本发明的有益效果:The beneficial effects of this invention are:

网篮组件的实施例中,花键连接在远端连接座与近端连接座之间,远端连接座靠近和远离所述近端连接座的过程中,有弹性的支撑骨架能够使花键具有收拢状态和打开状态,同时,花键包括柔性连接件,柔性连接件露出所述支撑骨架的远端的外伸部分连接有反折部分,反折部分固定在所述远端连接座上,能够通过自身的变形使花键的远端部分能够较为灵活地沿网篮组件周向偏摆、沿网篮组件径向移动,或者产生一定的扭转变形,在网篮组件贴靠目标生物组织时,能够具有较好的自适应性,从而更容易地贴靠目标生物组织。In one embodiment of the basket assembly, a spline is connected between a distal connector and a proximal connector. As the distal connector moves closer to and away from the proximal connector, the elastic support frame allows the spline to have a retracted and open state. Simultaneously, the spline includes a flexible connector. The extended portion of the flexible connector, protruding from the distal end of the support frame, is connected to a folded portion, which is fixed to the distal connector. This folded portion allows the distal portion of the spline to flexibly deflect circumferentially along the basket assembly, move radially along the basket assembly, or undergo a certain degree of torsional deformation through its own deformation. This provides good self-adaptability when the basket assembly is in contact with the target biological tissue, making it easier to adhere to the target biological tissue.

另外,通过反折部分的灵活变形,能够避免网篮组件硬性地接触生物体,有利于避免划伤生物体,安全性更好,也有利于避免花键受力过大而导致断裂。In addition, the flexible deformation of the folded part can prevent the basket assembly from making hard contact with the organism, which helps to avoid scratching the organism, improves safety, and also helps to prevent the spline from breaking due to excessive stress.

附图说明Attached Figure Description

图1是本发明中网篮组件的一个实施例处于完全打开状态时的结构示意图;Figure 1 is a schematic diagram of an embodiment of the basket assembly of the present invention in the fully open state;

图2是图1中花键部位的局部放大图;Figure 2 is a magnified view of the spline area in Figure 1;

图3是图2中花键与远端连接座的连接部位的剖视图;Figure 3 is a cross-sectional view of the connection between the spline and the distal connector in Figure 2;

图4是图2中花键与远端连接座的连接部位的立体图;Figure 4 is a perspective view of the connection between the spline and the distal connector in Figure 2;

图5是图1中的网篮组件处于收拢状态时的局部结构立体图;Figure 5 is a partial three-dimensional view of the basket assembly in Figure 1 when it is in the retracted state.

图6是图5中网篮组件的剖视图;Figure 6 is a cross-sectional view of the basket assembly in Figure 5;

图7是图6中花键的远端部位的结构示意图。Figure 7 is a schematic diagram of the structure of the distal part of the spline in Figure 6.

图中附图标记对应的特征名称列表:List of feature names corresponding to the labels in the figure:

100、近端连接座;100. Proximal connector;

200、远端连接座;200. Remote connector;

300、花键;310、支撑骨架;320、柔性电路板;321、绝缘基体;322、电极;323、柔性加强层;330、柔性连接件;331、外伸部分;332、弧形弯折部分;333、反折部分;300. Spline; 310. Support frame; 320. Flexible circuit board; 321. Insulating substrate; 322. Electrode; 323. Flexible reinforcing layer; 330. Flexible connector; 331. Extended portion; 332. Arc-shaped bending portion; 333. Reverse bending portion;

400、固定环;400. Retaining ring;

500、拉杆;500, pull rod;

600、传感器;600. Sensors;

700、插入管。700. Insert tube.

具体实施方式Detailed Implementation

下面通过具体实施方式结合附图对本发明作进一步详细说明,其中不同实施方式中类似元件采用了相关联的类似的元件标号。在以下的实施方式中,很多细节描述是为了使得本申请能被更好的理解。然而,本领域技术人员可以毫不费力地认识到,其中部分特征在不同情况下是可以省略的,或者可以由其他元件、材料、方法所替代。在某些情况下,本申请相关的一些操作并没有在说明书中显示或者描述,这是为了避免本申请的核心部分被过多的描述所淹没,而对于本领域技术人员而言,详细描述这些相关操作并不是必要的,他们根据说明书中的描述以及本领域的一般技术知识即可完整了解相关操作。The present invention will be further described in detail below with reference to specific embodiments and accompanying drawings, wherein similar elements in different embodiments are referred to by associated similar element reference numerals. In the following embodiments, many details are described to facilitate a better understanding of this 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 this application are not shown or described in the specification. This is to avoid obscuring the core parts of this 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.

另外,说明书中所描述的特点、操作或者特征可以以任意适当的方式结合形成各种实施方式。同时,方法描述中的各步骤或者动作也可以按照本领域技术人员所能显而易见的方式进行顺序调换或调整。因此,说明书和附图中的各种顺序只是为了清楚描述某一个实施例,并不意味着是必须的顺序,除非另有说明其中某个顺序是必须遵循的。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.

本文中为部件所编序号本身,例如“第一”、“第二”等,仅用于区分所描述的对象,不具有任何顺序或技术含义。而本申请所说“连接”、“联接”,如无特别说明,均包括直接和间接连接(联接)。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).

在本发明的实施例中,网篮组件的花键300设置有柔性连接件330,柔性连接件330的远端设有反折部分333,反折部分333固定在远端连接座200上,形成了可变形的铰链结构,能够使花键300在受到目标生物组织的反作用力时适应性地活动,从而能够更容易地贴靠目标生物组织。In an embodiment of the present invention, the spline 300 of the basket assembly is provided with a flexible connector 330. The distal end of the flexible connector 330 is provided with a folded portion 333, which is fixed on the distal connector 200, forming a deformable hinge structure. This allows the spline 300 to move adaptively when subjected to the reaction force of the target biological tissue, thereby making it easier to adhere to the target biological tissue.

本发明中网篮组件的实施例:Embodiment of the net basket assembly in this invention:

在一种实施例中,请参考图1,网篮组件包括近端连接座100、远端连接座200和花键300,近端连接座100供花键300的近端固定连接,远端连接座200供花键300的远端固定连接。In one embodiment, referring to FIG1, the basket assembly includes a proximal connector 100, a distal connector 200, and a spline 300. The proximal connector 100 provides a proximal fixed connection for the spline 300, and the distal connector 200 provides a distal fixed connection for the spline 300.

需要说明的是,本文中出现的“近端”和“远端”是医疗领域的常规称谓,对于待操作的器械来说,近端即靠近器械操作者的一端,远端即远离器械操作者的一端,远端通常是首先进入患者体内的一端;近端和远端可参考图1所显示的方位。It should be noted that the terms "proximal" and "distal" used in this article are conventional terms in the medical field. For the instrument to be operated, the proximal end is the end closer to the operator, and the distal end is the end farther away from the operator. The distal end is usually the end that enters the patient's body first. The proximal and distal ends can be referred to the orientation shown in Figure 1.

在一种具体实施例中,近端连接座100可以为一段管体,管体的内腔形成供花键300的近端插入并固定连接的连接腔。花键300与近端连接座100的具体固定方式不限,例如可以通过粘接、焊接等方式固定连接。在组装网篮导管时,近端连接座100可以与网篮导管的插入管连接,使得网篮组件能够被插入管输送至目标位置。In one specific embodiment, the proximal connector 100 can be a section of tubing, the inner cavity of which forms a connecting cavity for the proximal insertion and fixed connection of the spline 300. The specific fixing method between the spline 300 and the proximal connector 100 is not limited; for example, they can be fixedly connected by bonding, welding, or other methods. During the assembly of the basket conduit, the proximal connector 100 can be connected to the insertion tube of the basket conduit, allowing the basket assembly to be transported to the target location by the insertion tube.

请参考图3、图6,在一种具体实施例中,远端连接座200为套体结构。套体的中心孔可以供拉杆500连接,以通过拉杆500驱动远端连接座200移动。远端连接座200的中心孔内还可以设置传感器600,传感器600用于实现网篮组件的位置检测,例如可以是磁电定位传感器。上述拉杆500可以从网篮导管的插入管内通过并连接至网篮导管的手柄,手柄上可以设置驱动钮,操作驱动钮动作可以带动拉杆500向网篮组件的远端或近端移动,进而通过拉杆500驱动远端连接座200向网篮组件的远端或近端移动。Referring to Figures 3 and 6, in one specific embodiment, the distal connector 200 is a sleeve structure. A central hole in the sleeve allows a pull rod 500 to be connected, enabling the distal connector 200 to move via the pull rod 500. A sensor 600 can also be installed within the central hole of the distal connector 200. The sensor 600 is used for position detection of the basket assembly; for example, it can be a magnetoelectric positioning sensor. The pull rod 500 can pass through the insertion tube of the basket guide tube and connect to the handle of the basket guide tube. A drive button can be installed on the handle. Operating the drive button moves the pull rod 500 towards the distal or proximal end of the basket assembly, thereby driving the distal connector 200 to move towards the distal or proximal end of the basket assembly via the pull rod 500.

本领域技术人员可以理解,近端连接座100和远端连接座200还可以替换为其他结构形式,能够实现花键300的安装即可;近端连接座100和远端连接座200上连接的附件也可以根据需要设置。并且,本领域技术人员可以理解,拉杆500、手柄的具体结构可以参考相关技术中的已有结构,考虑到与本申请的创新内容和所要解决的技术问题无直接关联,此处不再赘述。Those skilled in the art will understand that the proximal connector 100 and the distal connector 200 can be replaced with other structural forms, as long as the spline 300 can be installed; the accessories connected to the proximal connector 100 and the distal connector 200 can also be set as needed. Furthermore, those skilled in the art will understand that the specific structure of the pull rod 500 and the handle can refer to existing structures in related technologies, and 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.

由于近端连接座100固定在插入管700上,因此,当远端连接座200向网篮组件的近端移动时,远端连接座200逐渐靠近近端连接座100,网篮组件由收拢状态逐渐打开,直至运动至最大行程,此时网篮组件处于完全打开状态。网篮组件在打开的过程中,由于花键300的主体部分具有弹性,因此,花键300能够平滑地向网篮组件的径向外侧弯曲,如图1至图4所示;当远端连接座200向网篮组件的远端移动时,远端连接座200逐渐远离近端连接座100,网篮组件逐渐收拢,直至运动至最大行程,此时网篮组件处于完全收拢状态,各花键300的主体部分处于平直状态,如图5和图6所示。Since the proximal connector 100 is fixed to the insertion tube 700, when the distal connector 200 moves towards the proximal end of the basket assembly, the distal connector 200 gradually approaches the proximal connector 100, and the basket assembly gradually opens from a retracted state until it reaches its maximum stroke, at which point the basket assembly is in a fully open state. During the opening process, due to the elasticity of the main body of the spline 300, the spline 300 can smoothly bend radially outwards towards the basket assembly, as shown in Figures 1 to 4. When the distal connector 200 moves towards the distal end of the basket assembly, the distal connector 200 gradually moves away from the proximal connector 100, and the basket assembly gradually retracts until it reaches its maximum stroke, at which point the basket assembly is in a fully retracted state, and the main body of each spline 300 is in a straight state, as shown in Figures 5 and 6.

需要说明的是,网篮组件的打开状态是指网篮组件能够用于心脏的电生理标测或消融的状态;根据目标生物组织的形态和尺寸,网篮组件可以具有不同的打开程度。图1至图4中,仅显示了网篮组件完全打开时的状态。It should be noted that the open state of the basket assembly refers to the state in which the basket assembly can be used for electrophysiological mapping or ablation of the heart; the basket assembly can have different degrees of opening depending on the morphology and size of the target biological tissue. Figures 1 to 4 only show the state when the basket assembly is fully open.

花键300的自身结构和花键300在近端连接座100和远端连接座200之间的连接结构会影响网篮组件的打开形态,下面将具体介绍。需要说明的是,本发明中不限制花键300的数量。The structure of the spline 300 itself and the connection structure of the spline 300 between the proximal connector 100 and the distal connector 200 will affect the opening shape of the basket assembly, which will be described in detail below. It should be noted that the number of splines 300 is not limited in this invention.

在一些实施例中,花键300可以包括支撑骨架310和柔性电路板320。In some embodiments, spline 300 may include a support frame 310 and a flexible circuit board 320.

支撑骨架310具有弹性,可以由弹性金属制成,例如镍钛合金,具有较好的生物相容性并且能够在受外力变形后较好地回弹到初始形状。支撑骨架310在远端连接座200处于自由状态时可以为直线结构,此时支撑骨架310能够使花键300贴近远端连接座200和拉杆500,使网篮组件尽量收拢为较小的径向尺寸。在一些实施例中,支撑骨架310可以是片状,便于柔性电路板320的连接。本领域技术人员可以理解,在一些其他实施例中,支撑骨架310还可以替换为其他形式,例如线状。The support frame 310 is elastic and can be made of an elastic metal, such as a nickel-titanium alloy, which has good biocompatibility and can rebound well to its initial shape after being deformed by external force. When the distal connector 200 is in a free state, the support frame 310 can be a straight structure, allowing the spline 300 to be close to the distal connector 200 and the pull rod 500, thus minimizing the radial dimension of the basket assembly. In some embodiments, the support frame 310 can be sheet-like, facilitating the connection of the flexible circuit board 320. Those skilled in the art will understand that in some other embodiments, the support frame 310 can also be replaced with other forms, such as a linear form.

柔性电路板320具有内侧面,内侧面为柔性电路板320靠近近端连接座100与远端连接座200的连线的侧面。在一种具体实施例中,支撑骨架310可以设置在柔性电路板320的内侧面上,这样可以使柔性电路板320上的电极322朝向网篮组件的外侧,从而能够贴靠到目标生物组织上。柔性电路板320可以采用粘接方式固定在支撑骨架310上,粘接剂可以采用聚氨酯胶、UV胶、环氧树脂、丙烯酸树脂等。支撑骨架310的近端可以与花键300的近端平齐,支撑骨架310和柔性电路板320与支撑骨架310连接的部分整体形成花键的主体部分。The flexible circuit board 320 has an inner side surface, which is the side of the flexible circuit board 320 near the line connecting the proximal connector 100 and the distal connector 200. In one specific embodiment, the support frame 310 can be disposed on the inner side surface of the flexible circuit board 320, so that the electrodes 322 on the flexible circuit board 320 face the outer side of the basket assembly, thereby enabling them to adhere to the target biological tissue. The flexible circuit board 320 can be fixed to the support frame 310 by adhesive bonding, and the adhesive can be polyurethane glue, UV glue, epoxy resin, acrylic resin, etc. The proximal end of the support frame 310 can be flush with the proximal end of the spline 300, and the portion of the support frame 310 and the flexible circuit board 320 connected to the support frame 310 together form the main body of the spline.

在一种具体实施例中,柔性电路板320可以包括绝缘基体321和电极322。本领域技术人员应当知晓:绝缘基体321的材质可以是聚酰亚胺(Polyimide,PI)、聚对苯二甲酸乙二醇酯(Polyethylene Terephthalate,PET)等,而电极322的材质可以为铂铱合金、不锈钢合金、铜等。电极322在绝缘基体321上的结合方式不限,例如可以通过粘贴、蚀刻、镀层等方式结合到绝缘基体321上。电极322具有暴露的放电表面,使用时能够形成电场,在本申请中单个花键300上的电极322数量、形状、尺寸和分布位置不做限定,本领域技术人员可以根据需要设计。在一些实施例中,柔性电路板320还可以包括覆盖层,覆盖层的材质可以与绝缘基体321相同,能够与绝缘基体321通过粘接、热压等方式结合在一起,对绝缘基体321上的电路起到防护作用。In one specific embodiment, the flexible circuit board 320 may include an insulating substrate 321 and electrodes 322. Those skilled in the art will understand that the insulating substrate 321 may be made of polyimide (PI), polyethylene terephthalate (PET), etc., while the electrodes 322 may be made of platinum-iridium alloy, stainless steel alloy, copper, etc. The bonding method of the electrodes 322 to the insulating substrate 321 is not limited; for example, they can be bonded to the insulating substrate 321 by means of bonding, etching, plating, etc. The electrodes 322 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 322 on a single spline 300 are not limited, and those skilled in the art can design them as needed. In some embodiments, the flexible circuit board 320 may also include a cover layer. The material of the cover layer may be the same as that of the insulating substrate 321, and it can be bonded to the insulating substrate 321 by means of bonding, hot pressing, etc., providing protection for the circuit on the insulating substrate 321.

为了使柔性电路板320上的电极322能够更好地贴靠目标生物组织,在一种实施例中,如图3和图7所示,柔性电路板320的长度大于支撑骨架310的长度,柔性电路板320的远端伸出支撑骨架310的远端,形成外伸部分331;另外,柔性电路板320包括反折部分333,反折部分333与外伸部分331连接并折向网篮组件的近端,反折部分333固定在远端连接座200上。柔性电路板320的上述外伸部分331和反折部分333构成了柔性连接件330,能够形成柔性的铰链,从而增加花键300远端的灵活性。在网篮组件受到与网篮组件的轴向具有夹角的作用力时,各相应花键300均能够相对容易地产生位移,例如沿图2中的双向箭头所示的方向产生位移,再如沿网篮组件上与相应花键300对应的径向产生位移,能够增加整个网篮组件的顺应性,以更吻合地贴靠目标生物组织。To enable the electrodes 322 on the flexible circuit board 320 to better adhere to the target biological tissue, in one embodiment, as shown in Figures 3 and 7, the length of the flexible circuit board 320 is greater than the length of the support frame 310. The distal end of the flexible circuit board 320 extends beyond the distal end of the support frame 310, forming an overhang portion 331. Additionally, the flexible circuit board 320 includes a folded portion 333, which connects to the overhang portion 331 and folds towards the proximal end of the basket assembly. The folded portion 333 is fixed to the distal connector 200. The aforementioned overhang portion 331 and folded portion 333 of the flexible circuit board 320 constitute a flexible connector 330, capable of forming a flexible hinge, thereby increasing the flexibility of the distal end of the spline 300. When the basket assembly is subjected to a force that forms an angle with the axial direction of the basket assembly, each corresponding spline 300 can be displaced relatively easily, for example, in the direction indicated by the bidirectional arrow in Figure 2, or in the radial direction corresponding to the corresponding spline 300 on the basket assembly. This can increase the compliance of the entire basket assembly, so as to fit more closely to the target biological tissue.

另外,柔性连接件330还能够避免外力导致柔性电路板320上的开口撕裂而导致花键300断裂,能够保证网篮组件的可靠性。In addition, the flexible connector 330 can also prevent the spline 300 from breaking due to the tearing of the opening on the flexible circuit board 320 caused by external force, thus ensuring the reliability of the basket assembly.

并且,网篮导管的花键300沿圆周方向间隔布置,在使用网篮导管的过程中,目标生物组织可能进入花键300之间的间隔内,网篮组件转动或移动的过程中有可能容易刮伤生物组织,而外伸部分331和反折部分333形成的柔性铰链能够避免花键300与生物组织之间出现硬接触,有利于避免网篮组件刮伤生物组织,提升手术安全性。Furthermore, the splines 300 of the basket cannula are arranged at intervals along the circumference. During the use of the basket cannula, the target biological tissue may enter the intervals between the splines 300. During the rotation or movement of the basket assembly, the biological tissue may be easily scratched. The flexible hinge formed by the extended portion 331 and the folded portion 333 can prevent hard contact between the splines 300 and the biological tissue, which helps to avoid the basket assembly scratching the biological tissue and improves the safety of the operation.

在一些其他实施例中,柔性连接件330也可以为独立于柔性电路板320设置的单独结构,例如由聚酰亚胺(Polyimide,PI)、聚对苯二甲酸乙二醇酯(Polyethylene Terephthalate,PET)等形成的片状结构。另外,在一些其他实施例中,柔性连接件330的近端可以直接与支撑骨架310的远端连接。In some other embodiments, the flexible connector 330 may also be a separate structure independent of the flexible circuit board 320, such as a sheet structure formed of polyimide (PI), polyethylene terephthalate (PET), etc. Additionally, in some other embodiments, the proximal end of the flexible connector 330 may be directly connected to the distal end of the support frame 310.

反折部分333与远端连接座200之间的固定方式不限,例如,在一种实施例中,网篮组件可以包括固定环400,固定环400套在远端连接座200的外侧,反折部分333具有固定段,固定段即反折部分333位于固定环400与远端连接座200的外周面之间的部分。将反折部分333连接至远端连接座200时,可以在网篮组件处于收拢状态下将花键300远端的柔性电路板320弯折,形成朝向网篮组件的近端延伸的反折部分333,将反折部分333插入远端连接座200与固定环400之间的间隙中,然后点胶,将反折部分333粘接固定到远端连接座200上。固定环400可以起到辅助固定作用和定位作用,能够保证各花键300的分布均匀性。在一些其他实施例中,反折部分333也可以依靠固定环400箍紧并实现固定。The fixing method between the folded portion 333 and the distal connector 200 is not limited. For example, in one embodiment, the basket assembly may include a retaining ring 400, which is sleeved on the outside of the distal connector 200. The folded portion 333 has a fixing section, which is the portion of the folded portion 333 located between the retaining ring 400 and the outer peripheral surface of the distal connector 200. When connecting the folded portion 333 to the distal connector 200, the flexible circuit board 320 at the distal end of the spline 300 can be bent in the folded state of the basket assembly to form a folded portion 333 extending towards the proximal end of the basket assembly. The folded portion 333 is inserted into the gap between the distal connector 200 and the retaining ring 400, and then glue is applied to bond and fix the folded portion 333 to the distal connector 200. The retaining ring 400 can play an auxiliary fixing and positioning role, ensuring the uniform distribution of each spline 300. In some other embodiments, the folded portion 333 can also be secured by the retaining ring 400.

上述固定环400可以为显影环,显影环能够同时用于网篮导管的头端的显影和固定柔性电路板320,有利于减少零部件,并且有助于节约空间并降低成本。本领域技术人员应当知晓,消融导管中的显影环可以由铂和铱等贵金属制成,这种环在X射线下能够清晰可见,因此医生在操作过程中能够精确地控制导管的位置。在一些其他实施例中,也可以设置单独的环体作为固定环400,仅用于将反折部分333固定到远端连接座200上。另外,在一些其他实施例中,反折部分333也可以直接粘接到远端连接座200的外周面或远端连接座200的中心孔孔壁上,反折部分333末端还可以设置L形弯折段,依靠L形弯折段固定到远端连接座200的端面上。The aforementioned fixing ring 400 can be a contrast ring, which can be used simultaneously for contrasting the tip of the basket catheter and fixing the flexible circuit board 320. This reduces the number of parts, saves space, and lowers costs. Those skilled in the art will know that the contrast ring in the ablation catheter can be made of precious metals such as platinum and iridium. Such rings are clearly visible under X-rays, allowing doctors to precisely control the catheter's position during the procedure. In some other embodiments, a separate ring body can be used as the fixing ring 400, solely for fixing the folded portion 333 to the distal connector 200. Additionally, in some other embodiments, the folded portion 333 can be directly bonded to the outer peripheral surface of the distal connector 200 or the wall of the central hole of the distal connector 200. The end of the folded portion 333 can also have an L-shaped bend, which fixes it to the end face of the distal connector 200.

反折部分333和远端连接座200之间能够形成固定连接区域,固定连接区域的远端侧边缘与柔性连接件330的远端之间具有间隔。网篮在打开过程中,上述间隔能够增加花键300移动的灵活性。采用固定环400固定反折部分333时,固定连接区域与反折部分333的固定段对应,并环绕远端连接座200的轴线分布。A fixed connection area can be formed between the folded portion 333 and the distal connector 200, and there is a gap between the distal edge of the fixed connection area and the distal end of the flexible connector 330. This gap increases the flexibility of the spline 300 during the opening of the basket. When the folded portion 333 is fixed using the retaining ring 400, the fixed connection area corresponds to the fixed segment of the folded portion 333 and is distributed around the axis of the distal connector 200.

在一种具体实施例中,柔性连接件330包括弧形弯折部分332,弧形弯折部分332连接在外伸部分331和反折部分333之间,弧形弯折部分332与外伸部分331和反折部分333形成“U”形,“U”形的开口朝向网篮组件的近端。设置弯折部分能够实现柔性电路板320的平滑反折,更有利于避免柔性电路板320断裂。在一些其他实施例中,反折部分333也可以直接反折,在外伸部分331与反折部分333之间形成折痕。In one embodiment, the flexible connector 330 includes an arc-shaped bend 332, which connects the extended portion 331 and the reverse bend 333. The arc-shaped bend 332, the extended portion 331, and the reverse bend 333 form a "U" shape, with the opening of the "U" facing the proximal end of the basket assembly. The bend allows for a smooth reverse bend of the flexible circuit board 320, which is more conducive to preventing breakage of the flexible circuit board 320. In some other embodiments, the reverse bend 333 can also be directly folded back, forming a crease between the extended portion 331 and the reverse bend 333.

在一种实施例中,请参考图5和图6,弧形弯折部分332凸出远端连接座200的远端端面;在一些其他实施例中,弧形弯折部分332的远端也可以与远端连接座200的远端端面平齐。网篮在打开过程中,采用上述凸出或平齐结构能够增加花键300移动的灵活性,并且使得网篮组件打开后远端侧能够更加平整,远端连接座200不会凸出花键300,在贴靠心肌时,可让电极322更好地贴靠目标生物组织,当医生用力贴靠心肌时,相比远端连接座凸出花键的结构,产生的压强也更小,有助于增加患者的安全性。In one embodiment, referring to Figures 5 and 6, the arc-shaped bend 332 protrudes from the distal end face of the distal connector 200; in some other embodiments, the distal end of the arc-shaped bend 332 may also be flush with the distal end face of the distal connector 200. During the opening process, the aforementioned protruding or flush structure increases the flexibility of the spline 300's movement and makes the distal side of the basket assembly flatter after opening, preventing the distal connector 200 from protruding from the spline 300. When applied to the myocardium, this allows the electrode 322 to better adhere to the target biological tissue. When the doctor applies force to the myocardium, the pressure generated is also lower compared to a structure where the distal connector protrudes from the spline, thus increasing patient safety.

当然,在另外一些其他实施例中,弧形弯折部分332的远端也可以相比于远端连接座200的远端端面更靠近网篮组件的近端。Of course, in some other embodiments, the distal end of the arc-shaped bend 332 may be closer to the proximal end of the basket assembly than the distal end face of the distal connector 200.

在一种实施例中,网篮组件还可以包括固化胶体(图中未显示),固化胶体的至少一部分位于固定环400的远端侧,固化胶体具有弹性;上述固化胶体可以由聚氨酯、环氧树脂、丙烯酸酯等胶液固化形成。柔性连接件330具有位于固定段的远端侧的过渡段,固化胶体将过渡段固定在远端连接座200上。通过设置固化胶体和过渡段,具有弹性的固化胶体能够跟随柔性连接件330出现变形,起到缓冲和保护作用,柔性电路板320形成的柔性连接件330在发生活动时不会与固定环400形成摩擦或被固定环400切割,有利于避免柔性电路板320断裂,能够提高网篮组件的工作可靠性。In one embodiment, the basket assembly may further include a curable adhesive (not shown in the figure), at least a portion of which is located on the distal side of the fixing ring 400. The curable adhesive is elastic. The curable adhesive can be formed by curing polyurethane, epoxy resin, acrylate, or other adhesives. The flexible connector 330 has a transition section located on the distal side of the fixing section, and the curable adhesive fixes the transition section to the distal connector 200. By providing the curable adhesive and the transition section, the elastic curable adhesive can deform along with the flexible connector 330, providing cushioning and protection. The flexible connector 330 formed by the flexible circuit board 320 will not rub against or be cut by the fixing ring 400 during movement, which helps prevent breakage of the flexible circuit board 320 and improves the operational reliability of the basket assembly.

请参考图7,在一种实施例中,柔性电路板320包括柔性加强层323,柔性加强层323设置在柔性电路板320的内侧面上。在一些实施例中,柔性加强层323可以为聚氨酯、聚酰亚胺、聚乙烯纤维、聚酯纤维、尼龙纤维、涤纶纤维、聚对苯二甲酸乙二醇酯等,柔性加强层323可以粘接固定在绝缘基体321背向电极322的一侧,柔性加强层323能够随绝缘基体321同步弯折以提高柔性电路板320的弯曲疲劳强度。在一种实施例中,柔性加强层323可以与绝缘基体321具有相同的宽度;在一些其他实施例中,柔性加强层323的宽度还可以小于绝缘基体321或大于绝缘基体321。本领域技术人员可以理解,柔性加强层323的柔性应当大于支撑骨架310的柔性,即相比于支撑骨架310能够更容易地变形。柔性加强层323可以仅设置在柔性电路板320用于形成柔性连接件330的位置,也可以设置于整个柔性电路板320。Referring to Figure 7, in one embodiment, the flexible circuit board 320 includes a flexible reinforcing layer 323 disposed on the inner surface of the flexible circuit board 320. In some embodiments, the flexible reinforcing layer 323 can be polyurethane, polyimide, polyethylene fiber, polyester fiber, nylon fiber, polyester fiber, polyethylene terephthalate, etc. The flexible reinforcing layer 323 can be bonded and fixed to the side of the insulating substrate 321 facing away from the electrode 322. The flexible reinforcing layer 323 can be bent synchronously with the insulating substrate 321 to improve the bending fatigue strength of the flexible circuit board 320. In one embodiment, the flexible reinforcing layer 323 can have the same width as the insulating substrate 321; in some other embodiments, the width of the flexible reinforcing layer 323 can be smaller or larger than the insulating substrate 321. Those skilled in the art will understand that the flexibility of the flexible reinforcing layer 323 should be greater than the flexibility of the supporting frame 310, that is, it can be deformed more easily than the supporting frame 310. The flexible reinforcing layer 323 can be provided only at the location on the flexible circuit board 320 used to form the flexible connector 330, or it can be provided on the entire flexible circuit board 320.

在一种实施例中,支撑骨架310的近端平行于近端连接座100与远端连接座200的连线,支撑骨架310的近端固定在近端连接座100上,花键300处于收拢状态时,反折部分333平行于支撑骨架310。支撑骨架310的近端和反折部分333采用上述结构,网篮组件打开时能够形成远端直径大、近端直径小的梨形结构,能够更容易地满足标测或消融需求。在一些其他实施例中,反折部分333也可以与网篮组件的轴线具有夹角。In one embodiment, the proximal end of the support frame 310 is parallel to the line connecting the proximal connector 100 and the distal connector 200. The proximal end of the support frame 310 is fixed to the proximal connector 100. When the spline 300 is in the retracted state, the folded portion 333 is parallel to the support frame 310. With the above-described structure of the proximal end and the folded portion 333 of the support frame 310, the basket assembly can form a pear-shaped structure with a larger distal diameter and a smaller proximal diameter when opened, making it easier to meet mapping or ablation requirements. In some other embodiments, the folded portion 333 may also have an angle with the axis of the basket assembly.

另外需要说明的是,包括有上述柔性连接件330的网篮组件可以用于心脏的电生理标测。在一些其他实施例中,包括有上述柔性连接件330的网篮组件也可以用于心脏的消融,例如脉冲电场消融(PFA)或者射频消融(RF)。It should also be noted that the basket assembly including the aforementioned flexible connector 330 can be used for electrophysiological mapping of the heart. In some other embodiments, the basket assembly including the aforementioned flexible connector 330 can also be used for cardiac ablation, such as pulsed electric field ablation (PFA) or radiofrequency ablation (RF).

本发明中网篮导管的实施例:Embodiments of the basket conduit in this invention:

网篮导管包括手柄、插入管、网篮组件和拉杆500,插入管连接在手柄的远端,网篮组件连接在插入管的远端,网篮组件为上述任意实施例中的网篮组件,此处不再赘述。拉杆500活动设置在插入管中,拉杆500与网篮组件的远端连接座200连接以驱动远端连接座200靠近和远离近端连接座100。The basket guide tube includes a handle, an insertion tube, a basket assembly, and a pull rod 500. The insertion tube is connected to the distal end of the handle, and the basket assembly is connected to the distal end of the insertion tube. The basket assembly is any of the basket assemblies described in the above embodiments, and will not be repeated here. The pull rod 500 is movably disposed in the insertion tube and is connected to the distal end connector 200 of the basket assembly to drive the distal end connector 200 closer to and further away from the proximal end connector 100.

以上应用了具体个例对本发明进行阐述,只是用于帮助理解本发明,并不用以限制本发明。对于本发明所属技术领域的技术人员,依据本发明的思想,还可以做出若干简单推演、变形或替换。The above examples illustrate the present invention only to aid in understanding it and are not intended to limit the scope of the invention. Those skilled in the art can make various simple deductions, modifications, or substitutions based on the principles of this invention.

Claims (10)

网篮组件,其特征在于,包括近端连接座、远端连接座和花键;A basket assembly, characterized in that it includes a near-end connector, a far-end connector, and a spline; 所述近端连接座供所述花键的近端固定连接,所述远端连接座供所述花键的远端固定连接;The proximal connector is used for fixed connection of the proximal end of the spline, and the distal connector is used for fixed connection of the distal end of the spline. 所述远端连接座在靠近和远离所述近端连接座的过程中,所述花键具有收拢状态和打开状态;As the distal connector approaches and moves away from the proximal connector, the spline has a retracted state and an open state. 所述花键包括:The spline includes: 支撑骨架,所述支撑骨架具有弹性;A support frame, wherein the support frame is elastic; 柔性连接件,所述柔性连接件附着于所述支撑骨架上,所述柔性连接件包括外伸部分和反折部分,所述外伸部分露出所述支撑骨架的远端,所述反折部分与所述外伸部分连接并折向所述网篮组件的近端,所述反折部分固定在所述远端连接座上。A flexible connector is attached to the support frame. The flexible connector includes an extended portion and a folded portion. The extended portion protrudes from the distal end of the support frame. The folded portion is connected to the extended portion and folded towards the proximal end of the basket assembly. The folded portion is fixed to the distal end connector. 如权利要求1所述的网篮组件,其特征在于,所述柔性连接件包括弧形弯折部分,所述弧形弯折部分连接在所述外伸部分和所述反折部分之间,所述弧形弯折部分与所述外伸部分和所述反折部分形成“U”形,所述“U”形的开口朝向所述网篮组件的近端。The basket assembly as claimed in claim 1, wherein the flexible connector includes an arc-shaped bend portion connected between the extended portion and the reverse bend portion, the arc-shaped bend portion forming a "U" shape with the extended portion and the reverse bend portion, and the opening of the "U" shape facing the proximal end of the basket assembly. 如权利要求2所述的网篮组件,其特征在于,所述弧形弯折部分凸出所述远端连接座的远端端面,或者,所述弧形弯折部分的远端与所述远端连接座的远端端面平齐。The basket assembly as claimed in claim 2 is characterized in that the arc-shaped bend protrudes from the distal end face of the distal connector, or the distal end of the arc-shaped bend is flush with the distal end face of the distal connector. 如权利要求1至3中任一项所述的网篮组件,其特征在于,包括柔性电路板,所述柔性电路板包括绝缘基体和电极,所述柔性连接件由所述柔性电路板形成。The basket assembly as claimed in any one of claims 1 to 3 is characterized in that it includes a flexible circuit board, the flexible circuit board including an insulating substrate and electrodes, and the flexible connector is formed by the flexible circuit board. 如权利要求4所述的网篮组件,其特征在于,所述柔性电路板具有内侧面,所述内侧面为所述柔性电路板靠近所述近端连接座与所述远端连接座的连线的一侧,所述内侧面上设有柔性加强层。The basket assembly as claimed in claim 4, wherein the flexible circuit board has an inner side surface, the inner side surface being the side of the flexible circuit board near the line connecting the proximal connector and the distal connector, and a flexible reinforcing layer is provided on the inner side surface. 如权利要求4所述的网篮组件,其特征在于,所述柔性电路板具有内侧面,所述内侧面为所述柔性电路板靠近所述近端连接座与所述远端连接座的连线的一侧,所述支撑骨架设置在所述柔性电路板的内侧面上。The basket assembly as claimed in claim 4, wherein the flexible circuit board has an inner side surface, the inner side surface being the side of the flexible circuit board near the line connecting the proximal connector and the distal connector, and the support frame is disposed on the inner side surface of the flexible circuit board. 如权利要求1至3中任一项所述的网篮组件,其特征在于,包括固定环,所述固定环套在所述远端连接座的外侧,所述反折部分具有固定段,所述固定段设置在所述固定环与所述远端连接座的外周面之间。The basket assembly as described in any one of claims 1 to 3 is characterized in that it includes a retaining ring, the retaining ring being sleeved on the outside of the distal connecting seat, the folded portion having a fixing segment, the fixing segment being disposed between the retaining ring and the outer peripheral surface of the distal connecting seat. 如权利要求7所述的网篮组件,其特征在于,包括固化胶体,所述固化胶体的至少一部分位于所述固定环的远端侧,所述固化胶体具有弹性;所述柔性连接件具有位于所述固定段的远端侧的过渡段,所述固化胶体将所述过渡段固定在所述远端连接座上。The basket assembly of claim 7, characterized in that it includes a curing colloid, at least a portion of which is located on the distal side of the fixing ring, the curing colloid being elastic; the flexible connector having a transition section located on the distal side of the fixing section, the curing colloid fixing the transition section to the distal connector. 如权利要求1至3中任一项所述的网篮组件,其特征在于,所述支撑骨架的近端平行于所述近端连接座与远端连接座的连线,所述支撑骨架的近端固定在所述近端连接座上,所述花键处于收拢状态时,所述反折部分平行于所述支撑骨架。The basket assembly as described in any one of claims 1 to 3, characterized in that the proximal end of the support frame is parallel to the line connecting the proximal end connector and the distal end connector, the proximal end of the support frame is fixed on the proximal end connector, and when the spline is in the retracted state, the folded portion is parallel to the support frame. 网篮导管,其特征在于,包括:The basket guide tube is characterized by comprising: 手柄;handle; 插入管,所述插入管连接在所述手柄的远端;An insertion tube is connected to the distal end of the handle; 网篮组件,所述网篮组件为权利要求1至9中任一项所述的网篮组件,所述网篮组件连接在所述插入管的远端;A basket assembly, wherein the basket assembly is the basket assembly according to any one of claims 1 to 9, the basket assembly being connected to the distal end of the insertion tube; 以及拉杆,所述拉杆活动设置在所述插入管中,所述拉杆与所述网篮组件的远端连接座连接以驱动所述远端连接座靠近和远离所述近端连接座。And a pull rod, which is movably disposed in the insertion tube and is connected to the distal connector of the basket assembly to drive the distal connector toward and away from the proximal connector.
PCT/CN2024/102560 2024-06-28 2024-06-28 Basket assembly and basket catheter Pending WO2026000367A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/CN2024/102560 WO2026000367A1 (en) 2024-06-28 2024-06-28 Basket assembly and basket catheter

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/CN2024/102560 WO2026000367A1 (en) 2024-06-28 2024-06-28 Basket assembly and basket catheter

Publications (1)

Publication Number Publication Date
WO2026000367A1 true WO2026000367A1 (en) 2026-01-02

Family

ID=98220547

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2024/102560 Pending WO2026000367A1 (en) 2024-06-28 2024-06-28 Basket assembly and basket catheter

Country Status (1)

Country Link
WO (1) WO2026000367A1 (en)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104434083A (en) * 2013-09-16 2015-03-25 韦伯斯特生物官能(以色列)有限公司 Basket catheter with deflectable spine
CN114191071A (en) * 2021-11-19 2022-03-18 杭州德诺电生理医疗科技有限公司 Ablation device
CN114343831A (en) * 2020-10-12 2022-04-15 伯恩森斯韦伯斯特(以色列)有限责任公司 Basket Catheter with Balloon
CN115736931A (en) * 2023-01-05 2023-03-07 心航路医学科技(广州)有限公司 Basket electrode and basket catheter
CN116549093A (en) * 2022-01-28 2023-08-08 心航路医学科技(广州)有限公司 Ultrasonic double-layer basket ablation catheter
CN118236157A (en) * 2024-05-27 2024-06-25 心航路医学科技(广州)有限公司 Basket electrode skeleton, basket electrode assembly and basket catheter

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104434083A (en) * 2013-09-16 2015-03-25 韦伯斯特生物官能(以色列)有限公司 Basket catheter with deflectable spine
CN114343831A (en) * 2020-10-12 2022-04-15 伯恩森斯韦伯斯特(以色列)有限责任公司 Basket Catheter with Balloon
CN114191071A (en) * 2021-11-19 2022-03-18 杭州德诺电生理医疗科技有限公司 Ablation device
CN116549093A (en) * 2022-01-28 2023-08-08 心航路医学科技(广州)有限公司 Ultrasonic double-layer basket ablation catheter
CN115736931A (en) * 2023-01-05 2023-03-07 心航路医学科技(广州)有限公司 Basket electrode and basket catheter
CN118236157A (en) * 2024-05-27 2024-06-25 心航路医学科技(广州)有限公司 Basket electrode skeleton, basket electrode assembly and basket catheter

Similar Documents

Publication Publication Date Title
US12329448B2 (en) Flexible multi-arm catheter with diametrically opposed sensing electrodes
JP4209004B2 (en) Operable and deflectable catheter for vascular regeneration of ischemic myocardial tissue
JP4223102B2 (en) Operable DMR catheter with infusion tube
JP4223103B2 (en) Operable DMR catheter handle
CN103328033B (en) There is the seal wire of internal pressure sensor
JP6771878B2 (en) Basket catheter with distal tip of microelectrode array
US7522950B2 (en) Basket catheter with improved expansion mechanism
JP5653594B2 (en) Catheter having a bendable tip
JPH10137340A (en) Catheter, multifunctional wire used therefor, and method of manufacturing catheter
CN107773300A (en) Catheter with bipolar electrode spacer and related methods
JP2008508063A (en) Operable catheter
JP2004130114A (en) Catheter and method for mapping purkinje's fiber
AU2010241407A8 (en) Catheter with pressure measuring tip
CN111683716A (en) Catheter and method of making the same
CN118787432A (en) Basket assembly and basket catheter
JP4209003B2 (en) Thin-walled catheter with high torsional rigidity
CN114533129B (en) Intravascular ultrasound catheter with spring structure
JP3637216B2 (en) Endoscopic treatment tool
WO2026000367A1 (en) Basket assembly and basket catheter
US11234846B2 (en) Guide catheter and delivery system
CN219355028U (en) Core wire structure and micro-guide wire
CN218128740U (en) Ablation device
CN120345872B (en) OCT imaging catheter
JP6780162B1 (en) Guide wire type electrode catheter
WO2026011648A1 (en) Balloon catheter flexible circuit board, balloon electrode assembly, and balloon ablation catheter