Mesh basket electrode assembly and ablation catheter

Abstract

The utility model relates to the technical field of medical instruments, and provides a mesh basket electrode assembly and an ablation catheter, the mesh basket electrode assembly comprises a plurality of electrode arms, each electrode arm comprises an electrode layer, a first insulating layer, a metal framework layer and a second insulating layer which are laminated from top to bottom; and the edges of the first insulating layer and the second insulating layer are in contact so as to completely wrap the metal framework layer. According to the mesh basket electrode assembly provided by the utility model, the electrode layer and the metal framework layer are insulated and isolated by using the first insulating layer, and one surface, far away from the first insulating layer, of the metal framework layer is insulated and isolated by using the second insulating layer; moreover, the edge of the first insulating layer is in contact with the edge of the second insulating layer, and the metal framework layer is completely wrapped in the first insulating layer. Through the arrangement, the insulation effect of the metal framework layer can be improved, and the risk of discharge short circuit between the electrodes is obviously reduced.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, specifically to a basket electrode assembly and an ablation catheter. Background Technology

[0002] Ablation catheters play a crucial role in the field of cardiac electrophysiology, primarily used to treat cardiac diseases such as arrhythmias. In recent years, the use of ring-shaped multipolar ablation catheters has been widely adopted due to their advantages over monopolar ablation catheters, including shorter ablation time, less radiation exposure time, and reduced operator skill requirements. However, the unique structure of pulmonary veins and individual differences can prevent effective adhesion between the catheter and the target site, leading to insufficient electric field and inadequate therapeutic effects. Petal-shaped basket electrode assemblies, on the other hand, can adjust the size of the basket by the elastic bending of the circumferentially distributed basket framework to accommodate pulmonary vein cavities of varying sizes.

[0003] Existing wire baskets mainly consist of multiple electrode arms, each comprising a metal frame and electrodes mounted thereon. The metal frame is coated with an insulating material to prevent short circuits between the electrodes. However, since the metal frame is typically a thin metal sheet, the insulating material is difficult to adhere to its sides, resulting in suboptimal insulation performance of existing electrode arms. Utility Model Content

[0004] Therefore, this invention aims to solve the problem of unsatisfactory insulation effect of the electrode arms in existing net baskets, and thus provides a net basket electrode assembly and ablation catheter.

[0005] To solve the above-mentioned technical problems, the technical solution of this utility model is as follows:

[0006] On one hand, the present invention provides a basket electrode assembly, comprising: a plurality of electrode arms, wherein each electrode arm comprises an electrode layer, a first insulating layer, a metal skeleton layer and a second insulating layer stacked from top to bottom; the edges of the first insulating layer and the second insulating layer are in contact with each other so as to completely cover the metal skeleton layer.

[0007] Furthermore, the electrode layer, the first insulating layer, and the metal skeleton layer are all centrally located relative to the second insulating layer.

[0008] Furthermore, the widths of both the electrode layer and the metal skeleton layer are smaller than the width of the first insulating layer.

[0009] Furthermore, along the length direction of the electrode arm, the length of the metal skeleton layer is less than the length of the first insulating layer.

[0010] Furthermore, the second insulating layer has a groove on the side facing the metal skeleton layer, and the metal skeleton layer is at least partially embedded in the groove along the thickness direction of the electrode arm.

[0011] Furthermore, the entire metal skeleton layer is embedded in the groove so that the side of the metal skeleton layer facing the first insulating layer is flush with the side of the second insulating layer facing the first insulating layer.

[0012] Furthermore, along the width direction of the electrode arm, the thickness of the two edges of the second insulating layer is less than the thickness of the middle.

[0013] Furthermore, the surface of the metal skeleton layer is gold-plated, with a gold plating thickness ranging from 0.2 μmm to 1 μmm.

[0014] On the other hand, the present invention also provides an ablation catheter, including the basket electrode assembly described in any one of the above.

[0015] The technical solution of this utility model has the following advantages:

[0016] The basket electrode assembly provided by this utility model utilizes a first insulating layer to insulate and isolate the electrode layer from the metal skeleton layer, and a second insulating layer to insulate and isolate the side of the metal skeleton layer away from the first insulating layer; moreover, the edges of the first insulating layer and the second insulating layer are in contact, completely enclosing the metal skeleton layer. This configuration can improve the insulation effect of the metal skeleton layer and significantly reduce the risk of short circuits between the electrodes. Attached Figure Description

[0017] To more clearly illustrate the specific embodiments of this utility model or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this utility model. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0018] Figure 1 This is a schematic diagram showing the various electrode arms of the basket electrode assembly in a divergent state in one embodiment of the present invention;

[0019] Figure 2 for Figure 1 Sectional view at point AA;

[0020] Figure 3 This is a schematic diagram of the ablation catheter in one embodiment of the present invention.

[0021] Explanation of reference numerals in the attached figures:

[0022] 1. Basket electrode assembly; 2. Electrode arm; 3. Electrode layer; 4. First insulating layer; 5. Metal skeleton layer; 6. Second insulating layer; 7. Outer tube; 8. Inner tube assembly; 9. Planar end. Detailed Implementation

[0023] The technical solution of this utility model will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this utility model. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this utility model.

[0024] In the description of this utility model, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the accompanying drawings and are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this utility model. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0025] In the description of this utility model, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "joining" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances.

[0026] Furthermore, the technical features involved in the different embodiments of this utility model described below can be combined with each other as long as they do not conflict with each other.

[0027] like Figure 1 , Figure 2 As shown, this embodiment provides a basket electrode assembly 1, including: a plurality of electrode arms 2, each electrode arm 2 including an electrode layer 3, a first insulating layer 4, a metal skeleton layer 5, and a second insulating layer 6 stacked from top to bottom; the first insulating layer 4 insulates and isolates the electrode layer 3 from the metal skeleton layer 5; the second insulating layer 6 is used to insulate and isolate the side of the metal skeleton layer 5 away from the first insulating layer 4. The edges of the first insulating layer 4 and the second insulating layer 6 can contact each other to completely cover the metal skeleton layer 5.

[0028] The basket electrode assembly 1 provided in this embodiment uses a first insulating layer 4 to insulate and isolate the electrode layer 3 from the metal skeleton layer 5, and a second insulating layer 6 to insulate and isolate the side of the metal skeleton layer 5 away from the first insulating layer 4; moreover, the edges of the first insulating layer 4 and the second insulating layer 6 are in contact, completely covering the metal skeleton layer 5. This configuration can improve the insulation effect of the metal skeleton layer 5 and significantly reduce the risk of short circuits between electrodes.

[0029] In this configuration, the direction from top to bottom of electrode arm 2 corresponds to the direction from outside to inside, with the direction closer to the inner tube being the inner side and the direction farther from the inner tube being the outer side. For example, along the width of the metal skeleton layer 5, the edges of the first insulating layer 4 and the second insulating layer 6 can be bonded together to enclose the metal skeleton layer 5. For example, both the first insulating layer 4 and the second insulating layer 6 are made of materials with insulating properties. For example, the second insulating layer 6 can be an insulating thin film. This configuration can significantly reduce the risk of short circuits between electrodes.

[0030] In this configuration, the electrode layer 3, the first insulating layer 4, and the metal skeleton layer 5 are all centrally located relative to the second insulating layer 6; the widths of the electrode layer 3 and the metal skeleton layer 5 are both smaller than the width of the first insulating layer 4. This arrangement helps to prevent the generation of electric arcs.

[0031] Wherein, along the length direction of the electrode arm 2, the length of the metal skeleton layer 5 may be less than the length of the first insulating layer 4.

[0032] The second insulating layer 6 has a groove on the side facing the metal skeleton layer 5, and the metal skeleton layer 5 is at least partially embedded in the groove along the thickness direction of the electrode arm 2. For example, the metal skeleton layer 5 can be completely embedded in the groove so that the side of the metal skeleton layer 5 facing the first insulating layer 4 is flush with the side of the second insulating layer 6 facing the first insulating layer 4. With this configuration, the metal skeleton layer 5 is completely embedded in the second insulating layer 6, achieving the optimal effect of complete insulation by the metal skeleton layer 5, and also making the overall structure of the electrode arm 2 more compact and thinner.

[0033] In particular, along the width direction of the electrode arm 2, the thickness of the two edges of the second insulating layer 6 can be less than the thickness of the middle.

[0034] The metal skeleton layer 5 is at least partially embedded within the second insulating layer 6. For example, a groove adapted to the size and shape of the metal skeleton layer 5 can be provided on the second insulating layer 6, so that the entire metal skeleton layer 5 is embedded within the groove, and the upper surface of the metal skeleton layer 5 can be flush with the upper surface of the second insulating layer 6. For example, the thickness at both edges of the second insulating layer 6 can be less than the thickness in the middle, and the thicker area in the middle can be used to embed the metal skeleton layer 5.

[0035] The surface of the metal framework layer 5 is gold-plated, with a plating thickness ranging from 0.2 μmm to 1 μmm. For example, the plating thickness can be 0.2 μmm, 0.5 μmm, or 1 μmm, and can be designed according to actual needs. This configuration enhances the imaging effect of the metal framework layer 5 under X-rays.

[0036] For example, the metal skeleton layer 5 can be cut from shape memory metal sheets. Alternatively, the metal skeleton layer 5 can be integrally formed by spinning a planar high-toughness metal to improve the coordination of the electrode arm 2 during expansion and contraction deformation.

[0037] like Figure 3 As shown, another embodiment provides an ablation catheter, including: an outer tube 7; an inner tube assembly 8, the proximal end of which is movably inserted into the outer tube 7 along the axial direction of the outer tube 7; a plurality of electrode arms 2 extending from the distal end of the inner tube assembly 8 and converging at the distal end of the outer tube 7; the distal end of the inner tube assembly 8 has a planar structure so that the inner tube assembly 8 forms a planar end 9 at the distal end of the basket electrode assembly 1 after being connected to the distal end of the basket electrode assembly 1.

[0038] The ablation catheter provided in this embodiment has a basket electrode assembly 1 consisting of multiple electrode arms 2 extending from the distal end of the inner tube assembly 8 and converging at the distal end of the outer tube 7. The distal end of the inner tube assembly 8 has a planar structure, so that after the inner tube assembly 8 is connected to the distal end of the basket electrode assembly 1, a planar tip 9 is formed at the distal end of the basket electrode assembly 1. Compared with the ablation catheters in the prior art, since the distal end of the ablation catheter is a planar tip 9, the risk of the ablation catheter tip puncturing the inner wall of the heart chamber can be reduced when the ablation catheter enters the heart chamber during treatment.

[0039] The multiple electrode arms 2 are integral structures formed by cutting a single flexible electrode. In their natural state, the multiple electrode arms 2 have a structure that radiates outward from the center; for example, the multiple electrode arms 2 can be petal-shaped. For example, the distal ends of the multiple electrode arms 2 are connected with a certain size of connection area, while the proximal ends radiate outward. In use, an assembly hole can be provided in the center of the connection area at the distal ends of the multiple electrode arms 2 to facilitate connection with the inner tube assembly 8. The proximal ends of the multiple electrode arms 2 can all be fixedly connected to the outer tube 7. Compared with a basket electrode assembly 1 formed by coupling a single electrode arm 2 at its distal end in a similar way to its proximal end, this configuration results in higher overall strength for the basket electrode assembly 1. Moreover, the deformation of each electrode arm 2 under stress is consistent, which improves the coordination between the various electrode arms 2 of the entire basket electrode assembly 1.

[0040] In summary, the ablation catheter in this application has a planar end 9, and the metal skeleton layer 5 is integrally formed by spinning a planar high-toughness metal, resulting in higher coordination between the expansion and contraction deformation of the electrode arms 2.

[0041] The ablation catheter in this application has a high-toughness metal skeleton layer 5 that is fully covered by two layers of high-polymer insulating material, and the metal skeleton layer 5 has good insulation properties.

[0042] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the protection scope of this invention.

Claims

1. A basket electrode assembly, characterized in that, include: Multiple electrode arms (2), each electrode arm (2) comprising an electrode layer (3), a first insulating layer (4), a metal skeleton layer (5), and a second insulating layer (6) stacked from top to bottom; The first insulating layer (4) contacts the edge of the second insulating layer (6) to completely cover the metal skeleton layer (5).

2. The basket electrode assembly according to claim 1, characterized in that, The electrode layer (3), the first insulating layer (4), and the metal skeleton layer (5) are all centered relative to the second insulating layer (6).

3. The basket electrode assembly according to claim 1, characterized in that, The widths of both the electrode layer (3) and the metal skeleton layer (5) are smaller than the width of the first insulating layer (4).

4. The basket electrode assembly according to claim 1, characterized in that, Along the length direction of the electrode arm (2), the length of the metal skeleton layer (5) is less than the length of the first insulating layer (4).

5. The basket electrode assembly according to claim 1, characterized in that, The second insulating layer (6) has a groove on the side facing the metal skeleton layer (5), and the metal skeleton layer (5) is at least partially embedded in the groove along the thickness direction of the electrode arm (2).

6. The basket electrode assembly according to claim 5, characterized in that, The metal skeleton layer (5) is completely embedded in the groove so that the side of the metal skeleton layer (5) facing the first insulating layer (4) is flush with the side of the second insulating layer (6) facing the first insulating layer (4).

7. The basket electrode assembly according to claim 1, characterized in that, Along the width direction of the electrode arm (2), the thickness of the two edges of the second insulating layer (6) is less than the thickness in the middle.

8. The basket electrode assembly according to claim 1, characterized in that, The surface of the metal skeleton layer (5) is gold-plated, and the thickness of the gold plating ranges from 0.2μmm to 1μmm.

9. An ablation catheter, characterized in that, Includes the basket electrode assembly (1) according to any one of claims 1-8.

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