Catheter electrode assembly of balloon catheter and balloon catheter

Abstract

The invention relates to the field of electrophysiological catheters, in particular to a catheter electrode assembly of a balloon catheter and the balloon catheter. The catheter electrode assembly of the balloon catheter comprises a balloon body and an electrode plate, and the electrode plate is arranged on the balloon body and used for transmitting electric energy. At least two groups of electrode plates are arranged in the circumferential direction of the capsule body, each group of electrode plates comprises near-end electrode plates arranged on the near-end side of the capsule body and far-end electrode plates arranged on the far-end side of the capsule body, and the near-end electrode plates and the far-end electrode plates are arranged in the near-far end direction of the capsule body; the near-end pole piece forms a near-end gradual change area, and the size of the near-end gradual change area in the circumferential direction of the capsule body is gradually narrowed from the middle of the capsule body in the near-far end direction to the near end of the capsule body; the far-end pole piece forms a far-end gradual change area, and the size of the far-end gradual change area in the circumferential direction of the capsule body is gradually narrowed from the middle of the capsule body in the near-far end direction to the far end of the capsule body. The invention mainly solves the technical problem of how to enable the balloon catheter to better act with target tissues in different directions.

Description

Technical Field

[0001] This invention relates to the field of electrophysiological catheters, and more specifically to catheter electrode assemblies and balloon catheters. Background Technology

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

[0003] Most pulse ablation devices on the market are currently valve-shaped or basket-shaped catheters, which can be configured in different ways by controlling the push and pull of the core. Valve-shaped or basket-shaped catheters usually have multiple slender, flexible branches carrying ablation electrodes. In actual use, due to the continuous contraction and relaxation of the heart and the rapid flow of blood, it is not easy to ensure the stability of the catheter's shape in the body and the orientation and angle between the electrodes on the flexible branches. For tissues with special anatomical structures and complex morphologies, the discharge position is difficult to control, and there may even be situations where the ablation electrodes are squeezed or there are abnormal electrode connections, which prevent the effective transfer of ablation energy. The heat generated by abnormal electrodes may lead to the formation of more air bubbles in the blood, thereby increasing the risk of stroke in patients.

[0004] Another type of balloon catheter typically includes an insertion tube and a catheter electrode assembly. The electrode assembly is located at the distal end of the insertion tube. The balloon catheter can be inflated by filling it with liquid or gas, causing the flexible circuit boards distributed on the balloon to unfold into the desired shape so that the electrodes on the flexible circuit boards can contact the target tissue in the human body. Balloon catheters are advantageous for controlling the position of the ablation electrodes; however, balloon catheters need to consider how to interact with target tissues in different orientations. Summary of the Invention

[0005] The main technical problem solved by this invention is how to enable balloon catheters to better interact with target tissues in different locations.

[0006] In one aspect, one embodiment provides a catheter electrode assembly for a balloon catheter.

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

[0008] A capsule, the capsule being inflatable and contractible, the capsule having a proximal end and a distal end;

[0009] And electrode plates, which are disposed on the capsule body for transmitting electrical energy;

[0010] The electrode pads are provided in at least two sets along the circumference of the capsule. Each set of electrode pads includes a proximal electrode pad disposed on the proximal side of the capsule and a distal electrode pad disposed on the distal side of the capsule. The proximal electrode pads and the distal electrode pads are arranged along the proximal-distal direction of the capsule.

[0011] The proximal electrode forms a proximal gradient region, which gradually narrows from the middle of the proximal end of the capsule towards the proximal end along the circumferential dimension of the capsule body; the distal electrode forms a distal gradient region, which gradually narrows from the middle of the proximal end of the capsule body towards the distal end along the circumferential dimension of the capsule body.

[0012] In one embodiment, both the proximal and distal ends of the proximal electrode are arc-shaped, and the proximal gradient region is located between the arcs at both ends; and / or, both the proximal and distal ends of the distal electrode are arc-shaped, and the distal gradient region is located between the arcs at both ends.

[0013] In one embodiment, the catheter electrode assembly includes a flexible circuit board, the flexible circuit board including an insulating substrate and the electrode sheet, the insulating substrate being attached to the capsule, and the electrode sheet being fixed to the insulating substrate;

[0014] The flexible circuit board includes a proximal portion and a distal portion, which are respectively disposed on the proximal side and the distal side of the capsule. The insulating substrate of the proximal portion has a gradient shape that matches the proximal electrode; the insulating substrate of the distal portion has a gradient shape that matches the distal electrode.

[0015] In one embodiment, the flexible circuit board forms at least two circuit strips distributed circumferentially along the capsule, the circuit strips including a connecting portion connecting the proximal portion and the distal portion.

[0016] In one embodiment, the connecting portion is smaller in circumferential dimension than the proximal and distal portions.

[0017] In one embodiment, the number of circuit strips is 2 to 8.

[0018] In one embodiment, the flexible circuit board has an edge portion located around the electrode sheet, and at least a portion of the edge portion has through holes distributed thereon, the through holes being used to improve the compliance of the edge portion.

[0019] In one embodiment, the proximal electrode and the distal electrode are arranged symmetrically in the proximal-distal direction.

[0020] In one embodiment, the distal end of the capsule has a concave portion or a smooth structure.

[0021] Secondly, one implementation provides a balloon catheter.

[0022] Balloon catheters, including:

[0023] Operating handle;

[0024] An insertion tube is connected to the distal end of the operating handle;

[0025] A catheter electrode assembly, wherein the catheter electrode assembly is any one of the catheter electrode assemblies described above, and the catheter electrode assembly is connected to the distal end of the insertion tube.

[0026] The beneficial effects of this invention are:

[0027] The electrode pads on the surface of the balloon catheter include proximal and distal electrodes respectively arranged on the proximal and distal sides of the balloon. The proximal electrode forms a proximal gradient region, and the distal electrode forms a distal gradient region. After the balloon of the catheter electrode assembly is inflated, the aforementioned proximal and distal gradient regions can adapt to the structure of the balloon gradually decreasing in diameter from the middle to both sides in the proximal-distal direction after inflation. This creates the hardware conditions to make the distribution of the electrode pads more uniform across the entire balloon surface and to form a more uniform electric field around the catheter electrode assembly. This allows the proximal, distal, and proximal-distal sides of the catheter electrode assembly to act on target tissues in different positions of the human body, enabling flexible application of different postures to the target tissue, making it more convenient to use and helping to reduce surgical time. Attached Figure Description

[0028] Figure 1 This is a schematic diagram of the structure of one embodiment of the balloon catheter in this invention;

[0029] Figure 2 yes Figure 1 Three-dimensional of the catheter electrode assembly Figure 1 ;

[0030] Figure 3 yes Figure 1 Three-dimensional of the catheter electrode assembly Figure 2 ;

[0031] Figure 4 yes Figure 1 Orthographic projection view of the catheter electrode assembly in the image;

[0032] Figure 5 This is a comparative diagram of the front and back sides of a single flexible circuit board;

[0033] Figure 6 This is a schematic diagram of the ablation electric field formed by an embodiment of the balloon catheter in this invention;

[0034] Figure 7 This is a schematic diagram of an embodiment of the balloon catheter in this invention undergoing ablation in different postures;

[0035] Figure 8 This is a schematic diagram of an embodiment of the balloon catheter in the present invention in a contracted state.

[0036] List of feature names corresponding to the labels in the figure:

[0037] 100. Operating handle;

[0038] 200. Insertion tube; 210. Center rod;

[0039] 300. Catheter electrode assembly;

[0040] 310. Cyst;

[0041] 320. Flexible circuit board;

[0042] 321, Insulating substrate; 3211, Through hole;

[0043] 322, Electrode piece; 3221, Proximal electrode piece; 3222, Distal electrode piece;

[0044] 323, conductive line; 3231, solder pad;

[0045] 3241. Proximal portion; 3242. Distal portion; 3243. Intermediate connecting portion; 3244. Lead-out portion;

[0046] 400. Target organization. Detailed Implementation

[0047] The present invention 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.

[0048] 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.

[0049] 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).

[0050] In some embodiments of the present invention, the electrode pads on the capsule include a proximal electrode pad disposed on the proximal side of the capsule and a distal electrode pad disposed on the distal side of the capsule. The proximal electrode pad forms a gradually narrowing proximal gradient region, and the distal electrode pad forms a gradually narrowing distal gradient region. When the capsule is inflated, the wider end of the corresponding gradient region corresponds to the middle of the capsule with a larger diameter in the proximal-distal direction, while the narrower end of the corresponding gradient region corresponds to the proximal or distal end of the capsule with a smaller diameter. This makes the distribution of the electrode pads more uniform across the entire capsule surface, creating a more uniform electric field around the catheter electrode assembly. This allows the proximal side, distal side, and middle portion of the catheter electrode assembly to act on target tissues in different locations of the human body, enabling flexible application of different postures to the target tissue.

[0051] Examples of balloon catheters in this invention:

[0052] Please refer to Figure 1 In one embodiment, the balloon catheter includes an operating handle 100, an insertion tube 200, and a catheter electrode assembly 300, which are connected sequentially from the proximal end to the distal end of the balloon catheter.

[0053] The operating handle 100 allows the operator to grip and perform corresponding operations. Its specific operating functions can be designed as needed, such as adjusting the balloon catheter and controlling the inflation and contraction of the balloon. The insertion tube 200 is connected to the distal end of the operating handle 100, enabling the movement of the catheter electrode assembly 300 and providing a substrate for the corresponding circuits, fluid circuits, and / or gas circuits, allowing these circuits, fluid circuits, and / or gas circuits to connect to the catheter electrode assembly 300 via the operating handle 100. The catheter electrode assembly 300 includes a balloon body 310 and electrode pads 322. The balloon body 310 can inflate and contract, and the electrode pads 322 are disposed on the surface of the balloon body 310, inflating and contracting with the balloon body 310. When inflated, it can contact the target tissue 400, such as the myocardium causing atrial fibrillation, thereby achieving the transmission of electrical energy.

[0054] 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.

[0055] Furthermore, those skilled in the art should know that the capsule 310 of the catheter electrode assembly 300 in this invention can be made of polymer materials such as nylon (PA), block polyetheramide (PEBAX), polyethylene terephthalate (PET), and polyurethane (PU), and is flexible, capable of being filled with liquid or gas and contracting when the liquid or gas is discharged; when the capsule 310 is filled, it can generate tension and form a corresponding shape, such as spherical, ellipsoidal, or other desired shape; when the capsule 310 contracts, the catheter electrode assembly 300 transforms into a cylindrical structure, facilitating entry and exit from the sheath.

[0056] Electrode 322 can be located on flexible circuit board 320. Flexible circuit board 320 includes insulating substrate 321 and electrode 322. Insulating substrate 321 is attached to capsule 310, and electrode 322 is fixed to insulating substrate 321. The number of flexible circuit boards 320 can be set as needed, for example... Figure 2The capsule 310 has six flexible circuit boards 320, each strip-shaped, forming a circuit strip. These flexible circuit boards 320 are distributed circumferentially along the capsule 310, and each flexible circuit board 320 has a set of electrode sheets 322. The flexible circuit boards 320 can be fixed to the capsule by methods such as bonding or hot pressing, and can deform with the capsule 310 to achieve the desired shape for contact with the target tissue 400. When the capsule 310 is fully filled, it has a large outer surface area, allowing it to support electrodes of a larger area. Those skilled in the art will understand that the insulating substrate can be made of common materials in the field of flexible circuit boards, such as PI or PET; while the electrode sheets can be made of copper, silver, etc., and can be plated, such as with a gold plating layer. Of course, plating is not a necessary structure.

[0057] In some cases, the balloon catheter may also include a central strut 210 (e.g., Figure 4 , Figure 4 (The capsule is shown in a transparent state). A central rod 210 passes through the insertion tube 200 and enters the capsule 310. The distal end of the catheter electrode assembly 300 is fixedly connected to the central rod 210. The central rod 210 is used to move along the insertion tube 200 to adjust the position of the distal end of the capsule 310. For example, pushing the central rod 210 distally can increase the axial (i.e., proximal-distal) dimension of the capsule 310, while moving the central rod 210 proximally can decrease the axial dimension of the capsule 310. Those skilled in the art will understand that in some embodiments, the central rod 210 can be a solid rod or a hollow rod. When a hollow rod is used, fluid can also be delivered through the central rod 210. In addition, in some other embodiments, the central rod 210 is not a necessary structure and can be omitted, with the shape of the capsule 310 changed only by filling or draining fluid.

[0058] The specific structures of the aforementioned operating handle 100, insertion tube 200, electrode plate 322, center rod 210, and other components can be referred to existing structures in related technologies. Considering that they are not directly related to the innovative content of this application and the technical problem to be solved, they will not be described in detail here.

[0059] It should be noted that the balloon catheter in the embodiments of the present invention can be an ablation catheter for ablation of the target tissue 400, for example, for pulsed electric field ablation; in addition, in some other embodiments, the balloon catheter in the embodiments of the present invention can be a mapping catheter for collecting electrophysiological signals of the target tissue 400.

[0060] Depending on the relative position of the balloon catheter and the target tissue 400, during balloon catheter operation, the balloon catheter may need to be positioned distally at an angle towards the target tissue 400 (e.g., Figure 7a) In a state where it is located at a distance and directly facing the target organization 400 (e.g.) Figure 7 b), and in a position where the tissue is 400 degrees to the side facing the target tissue (e.g.) Figure 7 c) It may also be in a state where the proximal end is obliquely facing the target tissue 400 (not shown in the figure). However, in related technologies, considering factors such as the control of radial dimensions when the balloon catheter contracts and the firmness of the electrode pad 322, the electrode pad is often only set in the area between the middle of the proximal and distal ends of the balloon body 310 and the distal end of the balloon body 310. Therefore, the flexibility of use is poor and the requirements for the posture adjustment of the distal end of the balloon catheter are high.

[0061] In the embodiments of the balloon catheter of the present invention, please refer to... Figures 2 to 4 The electrode pads 322 on the catheter electrode assembly 300 include a proximal electrode 3221 disposed on the proximal side of the capsule 310 and a distal electrode 3222 disposed on the distal side of the capsule 310. The proximal electrode 3221 and the distal electrode 3222, located on the same flexible circuit board 320, are arranged along the proximal-distal direction of the capsule 310; the proximal electrode 3221 forms a proximal gradient region (e.g., Figure 5 The region located between the two double-dotted lines on the proximal electrode 3221, the proximal gradient region gradually narrows from the middle of the proximal end of the capsule 310 towards the proximal end of the capsule 310 along the circumferential direction; the distal electrode 3222 forms the distal gradient region (e.g. Figure 5 The region located between the two double-dotted lines of the distal electrode 3222, the distal gradient region gradually narrows from the middle of the proximal end of the capsule 310 to the distal end of the capsule 310 along the circumferential direction.

[0062] By simultaneously setting the proximal electrode 3221 and the distal electrode 3222, and making the proximal electrode 3221 form a proximal gradient region and the distal electrode 3222 form a distal gradient region, the catheter electrode assembly 300 can generate an electric field in the proximal, distal, and mid-proximal directions. The electric field coverage is comprehensive, and the proximal and distal gradient regions can adapt to the characteristic that the diameter of the catheter electrode assembly 300 is large in the mid-proximal direction after inflation, gradually decreasing towards the proximal and distal ends, resulting in a more uniform electric field distribution. This allows the balloon catheter to achieve ablation with more flexible posture. In addition, since the proximal electrode 3221 and the distal electrode 3222 are respectively located on the proximal and distal sides of the balloon body 310, in conjunction with the proximal and distal gradient regions, when the catheter electrode assembly 300 contracts, such as Figure 8As shown, the proximal and distal portions of the catheter electrode assembly 300 can achieve higher structural stability by relying on the proximal electrode 3221 and the distal electrode 3222. The proximal and distal portions can form a smaller outer diameter, which facilitates passage through narrow sheaths and allows the catheter to move more smoothly back and forth in the sheath. This makes it easier for the balloon catheter to enter and exit the human body, reduces vascular access damage, and also enables continuous ablation and large-area coverage.

[0063] The proximal and distal gradient regions mentioned above can be arranged symmetrically or asymmetrically on both sides of their width direction (i.e., on both sides circumferentially along the capsule 310). For example, one side of the width direction can be straight relative to the axis of the catheter electrode assembly 300, while the other side can be inclined relative to the axis of the catheter electrode assembly 300. A symmetrical arrangement is more conducive to ensuring the morphological stability of the catheter electrode assembly 300 during filling and contraction.

[0064] In one embodiment, please refer to Figures 2 to 5 The proximal and distal ends of the proximal electrode 3221 are both arc-shaped, with a proximal gradient region located between the two arcs; the proximal and distal ends of the distal electrode 3222 are both arc-shaped, with a distal gradient region located between the two arcs. The arc-shaped structure at the distal end of the electrode 322, as described above, is more conducive to the contraction of the balloon body 310 and can also form a guiding structure, facilitating the entry and exit of the balloon catheter from the sheath. In some other embodiments, the proximal and distal ends of the proximal electrode 3221 and the distal electrode 3222 can also be other shapes, such as straight lines or angles.

[0065] Those skilled in the art will understand that the flexible circuit board 320 may include an insulating substrate 321 and electrode sheets 322, with the insulating substrate 321 attached to the capsule 310 and the electrode sheets 322 fixed to the insulating substrate 321. In one specific embodiment, please refer to... Figure 5 The flexible circuit board 320 includes a proximal portion 3241 and a distal portion 3242, which are respectively disposed on the proximal and distal sides of the capsule 310. The shape of the insulating substrate 321 of the proximal portion 3241 is a gradient shape matching the proximal electrode 3221; the shape of the insulating substrate 321 of the distal portion 3242 is a gradient shape matching the distal electrode 3222. Matching the shapes of the proximal and distal portions 3241 and 3242 of the insulating substrate 321 with the electrode 322 further ensures the morphological stability of the conduit electrode assembly 300 during filling and shrinking. In addition, in one embodiment, the proximal electrode 3221 and the distal electrode 3222 can be arranged symmetrically in the proximal-distal direction, which is more conducive to forming a uniform electric field.

[0066] When the balloon catheter is in operation, with the catheter electrode assembly 300 distally facing the target tissue 400, to avoid interference between the distal end of the catheter electrode assembly 300 and the target tissue 400, which could lead to patient injury, in some embodiments, the distal end of the balloon body 310 has a concave portion or a smooth structure. As an example, the distal end of the balloon body 310 can be provided with a cylindrical portion, which is bent in the opposite direction towards the proximal end of the balloon body 310 and then fixed to the distal end connector of the balloon body 310, thus forming a concave portion at the distal end of the balloon body 310.

[0067] In some embodiments, the flexible circuit board 320 has an edge portion located around the electrode sheet 322, and at least a portion of the edge portion has through holes 3211 distributed thereon. The through holes 3211 can reduce the strength of the edge portion and improve the compliance of the edge portion, thereby better preventing the insulating portion of the edge of the flexible circuit board 320 from peeling off from the capsule 310.

[0068] To facilitate the determination of ablation sites, the electrode pads 322 should be accurately positioned on the capsule 310 during manufacturing. In some embodiments, the flexible circuit board 320 may form at least two circuit strips distributed circumferentially along the capsule 310, each circuit strip including an intermediate connecting portion 3243 connecting the proximal portion 3241 and the distal portion 3242. The intermediate connecting portion 3243 enables the positioning of the relative positions between the proximal portion 3241 and the distal portion 3242, thereby better ensuring the relative positions of the electrode pads 322. In some other embodiments, the intermediate connecting portion 3243 may be omitted, and the positioning of the proximal portion 3241 and the distal portion 3242 may be achieved using a positioning fixture or the like.

[0069] In one specific embodiment, the intermediate connecting portion 3243 can be smaller in circumferential dimension along the capsule 310 than the proximal portion 3241 and the distal portion 3242. Since the diameter of the capsule 310 changes significantly in the proximal-distal direction during the inflation and deflation of the catheter electrode assembly 300, a thinner intermediate connecting portion 3243 helps reduce the stress between the flexible circuit board 320 and the capsule 310 during inflation and deflation, thus preventing the flexible circuit board 320 from peeling off. Furthermore, the aforementioned thin strip-shaped intermediate connecting portion 3243 allows the catheter electrode assembly 300 to form a cylindrical shape with high axial strength when the capsule 310 is in a contracted state. When the surgeon pushes the catheter electrode assembly 300 into the sheath, it helps the catheter electrode assembly 300 maintain its cylindrical shape, preventing abnormal bulging of the catheter electrode assembly 300 within the sheath due to a long pushing path, and preventing the electrode pads 322 from scraping the inner wall of the sheath.

[0070] Depending on the ablation requirements of the catheter electrode assembly 300, in some embodiments, the number of circuit strips can be 2 to 8. Since the outer diameter of the catheter electrode assembly 300 is generally not much different, this range of circuit strips can ensure that each electrode sheet 322 has a large contact area and facilitate the assembly of the flexible circuit board 320 and the capsule 310.

[0071] The electrode 322 on the flexible circuit board 320 can be connected to the conductive line 323. The conductive line 323 can be led to the operating handle 100 through the insertion tube 200, and then connected to the corresponding ablation host or mapping host through the connector on the operating handle 100. The connection method between the electrode 322 and the conductive line 323 is not limited. For example, the conductive line 323 can be etched on the insulating substrate 321 of the flexible circuit board 320, arranged to the lead-out portion 3244 near the end of the insulating substrate 321, and then soldered to the wire through the solder pad 3231. The conductive line 323 connected to the near electrode 3221 and the conductive line 323 connected to the far electrode 3222 can be set on different sides of the insulating substrate 321. The conductive line 323 on the back side can be arranged as follows: Figure 5 As shown by the dotted line; in addition, an insulating layer can be provided on the conductive line 323 to achieve insulation of the wire line. For example, the conductive line 323 with an outer insulating layer can be soldered to the back of the electrode plate 322, then pass through the capsule 310 and through the inner cavity of the capsule 310, and then continue to be laid to the operating handle 100.

[0072] When performing ablation using the balloon catheter of this invention, the balloon catheter can be connected to the ablation host. The ablation host connects the electrode pads 322 to circuits of corresponding polarity. For example, the electrode pads 322 on one flexible circuit board 320 are connected to the positive terminal, and the electrode pads 322 on an adjacent flexible circuit board 320 are connected to the negative terminal. This creates an electric field around the catheter electrode assembly 300 along the proximal and distal directions. Figure 6 As shown, when in contact with the target tissue 400, discharge is applied to the target tissue 400 to achieve pulsed electric field ablation.

[0073] Furthermore, during balloon inflation and deflation, the larger the area of ​​the flexible circuit board 320 in the catheter electrode assembly 300, the larger the space it occupies after deflation, making it difficult to control the radial dimensions. Moreover, during repeated balloon inflation and deflation, cracks, detachment, and adhesive leakage are more likely to occur between the flexible circuit board 320 and the balloon body 310, making it difficult to ensure the connection stability between the flexible circuit board 320 and the balloon body 310. In contrast, the electrode sheet 322 of the catheter electrode assembly 300 in this invention is provided with a gradient region that adapts to the proximal end of the balloon body 310, and the circuit strip includes an intermediate connecting portion 3243 connecting the proximal portion 3241 and the distal portion 3242, which is beneficial for controlling the radial dimensions of the catheter electrode assembly 300 and improving the connection stability between the flexible circuit board 320 and the balloon body 310.

[0074] An embodiment of the catheter electrode assembly of the balloon catheter in this invention:

[0075] The structure of the catheter electrode assembly of the balloon catheter can be the same as that of the catheter electrode assembly 300 in any of the above embodiments of the balloon catheter, and will not be described again here.

[0076] 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

1. A catheter electrode assembly for a balloon catheter, characterized in that, include: A capsule, the capsule being inflatable and contractible, the capsule having a proximal end and a distal end; And electrode plates, which are disposed on the capsule body for transmitting electrical energy; The electrode pads are provided in at least two sets along the circumference of the capsule. Each set of electrode pads includes a proximal electrode pad disposed on the proximal side of the capsule and a distal electrode pad disposed on the distal side of the capsule. The proximal electrode pads and the distal electrode pads are arranged along the proximal-distal direction of the capsule. The proximal electrode forms a proximal gradient region, which gradually narrows from the middle of the proximal end of the capsule towards the proximal end along the circumferential dimension of the capsule body; the distal electrode forms a distal gradient region, which gradually narrows from the middle of the proximal end of the capsule body towards the distal end along the circumferential dimension of the capsule body.

2. The catheter electrode assembly as described in claim 1, characterized in that, The proximal and distal ends of the proximal electrode are both arc-shaped, and the proximal gradient region is located between the arcs at both ends; and / or, the proximal and distal ends of the distal electrode are both arc-shaped, and the distal gradient region is located between the arcs at both ends.

3. The catheter electrode assembly as described in claim 1, characterized in that, The catheter electrode assembly includes a flexible circuit board, which includes an insulating substrate and an electrode sheet. The insulating substrate is attached to the capsule, and the electrode sheet is fixed to the insulating substrate. The flexible circuit board includes a proximal portion and a distal portion, which are respectively disposed on the proximal side and the distal side of the capsule. The insulating substrate of the proximal portion has a gradient shape that matches the proximal electrode; the insulating substrate of the distal portion has a gradient shape that matches the distal electrode.

4. The catheter electrode assembly as described in claim 3, characterized in that, The flexible circuit board forms at least two circuit strips distributed circumferentially along the capsule, the circuit strips including connecting portions between the proximal portion and the distal portion.

5. The catheter electrode assembly as described in claim 4, characterized in that, The dimension of the connecting portion along the circumference of the capsule is smaller than that of the proximal portion and the distal portion.

6. The catheter electrode assembly as claimed in claim 4, characterized in that, The number of circuit strips is 2 to 8.

7. The catheter electrode assembly as described in any one of claims 3 to 6, characterized in that, The flexible circuit board has an edge portion located around the electrode sheet, and at least a portion of the edge portion has through holes distributed thereon, the through holes being used to improve the compliance of the edge portion.

8. The catheter electrode assembly as described in any one of claims 1 to 6, characterized in that, The proximal electrode and the distal electrode are arranged symmetrically in the proximal-distal direction.

9. The catheter electrode assembly as described in any one of claims 1 to 6, characterized in that, The distal end of the capsule has a concave portion or a smooth structure.

10. A balloon catheter, characterized in that, include: Operating handle; An insertion tube is connected to the distal end of the operating handle; A catheter electrode assembly, wherein the catheter electrode assembly is any one of claims 1 to 9, and the catheter electrode assembly is connected to the distal end of the insertion tube.

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