Catheter electrode assembly for balloon catheter, balloon catheter, and catheter system

Abstract

The present application relates to the field of balloon catheters, and in particular to a catheter electrode assembly for a balloon catheter, a balloon catheter, and a catheter system. The catheter electrode assembly for a balloon catheter comprises a balloon body and electrode sheets disposed on the balloon body for transmitting electrical energy, wherein at least two groups of electrode sheets are disposed along the circumference of the balloon body; each group of electrode sheets comprises a proximal electrode sheet disposed on the proximal side of the balloon body and a distal electrode sheet disposed on the distal side of the balloon body; the proximal electrode sheet and the distal electrode sheet are arranged in the proximal-distal direction of the balloon body; the proximal electrode sheet forms a proximal electrode region, and the size of the proximal electrode region along the circumference of the balloon body gradually narrows from the middle of the balloon body in the proximal-distal direction to the proximal end of the balloon body; and the distal electrode sheet forms a distal electrode region, and the size of the distal electrode region along the circumference of the balloon body gradually narrows from the middle of the balloon body in the proximal-distal direction to the distal end of the balloon body. The present application mainly solves the technical problem of how to achieve better operation of a balloon catheter on target tissues in different orientations.

Description

A catheter electrode assembly for a balloon catheter, a balloon catheter, and a catheter system. Technical Field

[0001] This application relates to the field of balloon catheters, specifically to a balloon catheter electrode assembly, a balloon catheter, and a catheter system. 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 addressed in this application is how to enable balloon catheters to better interact with target tissues in different locations.

[0006] One embodiment provides a catheter electrode assembly for a balloon catheter, comprising:

[0007] A capsule, the capsule being inflatable and contractible, the capsule having a proximal end and a distal end;

[0008] And electrode plates, which are disposed on the capsule body for transmitting electrical energy;

[0009] 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.

[0010] 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.

[0011] 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.

[0012] 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;

[0013] 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.

[0014] In one embodiment, the flexible circuit board forms circuit strips, the number of which is at least two, the circuit strips are distributed circumferentially along the capsule, and the circuit strips include connecting portions connecting the proximal portion and the distal portion.

[0015] In one embodiment, the connecting portion is smaller in circumferential dimension than the proximal and distal portions.

[0016] In one embodiment, the number of circuit strips is 2 to 8.

[0017] 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.

[0018] In one embodiment, the proximal electrode and the distal electrode are arranged symmetrically in the proximal-distal direction.

[0019] In one embodiment, the distal end of the capsule has a concave portion or a smooth structure.

[0020] In one embodiment, the electrode pad forms an electrode region exposed on the surface of the catheter electrode assembly, the electrode region including a proximal electrode region located on the proximal side of the capsule and a distal electrode region located on the distal side of the capsule;

[0021] The proximal electrode region is provided with a segmentation region, which divides the proximal electrode region into at least two mutually insulated independent electrodes; and / or, the distal electrode region is provided with a segmentation region, which divides the distal electrode region into at least two mutually insulated independent electrodes.

[0022] In one embodiment, the segmentation region is arranged along the surface contour of the conduit electrode assembly;

[0023] The segmentation region extends along the proximal-distal direction, and the segmentation region causes the electrodes of the corresponding electrode regions to be arranged at intervals along the circumferential direction of the capsule; or, the segmentation region extends along the surface of the catheter electrode assembly, and the extension direction intersects the proximal-distal direction, so that the electrodes of the corresponding electrode regions are arranged at intervals along the proximal-distal direction.

[0024] In one embodiment, the proximal and distal ends of the proximal electrode region are both arc-shaped, and / or the proximal and distal ends of the distal electrode region are both arc-shaped; the segmentation region passes through the middle of the arc length of the corresponding arc.

[0025] In one embodiment, the width of the segmented region is smaller than the dimension of the independent electrode sheet segmented by the segmented region along the width direction of the segmented region.

[0026] In one embodiment, the width of the segmented area is not less than 0.3 mm.

[0027] In one embodiment, the conduit electrode assembly includes an insulating material, the entire circumferential edge of the individual electrode is covered by the insulating material, and / or the segmented area is covered by the insulating material.

[0028] One embodiment provides a balloon catheter, comprising:

[0029] Operating handle;

[0030] An insertion tube is connected to the distal end of the operating handle;

[0031] 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.

[0032] One embodiment provides a catheter system including a balloon catheter, and an ablation unit and / or a mapping unit;

[0033] The balloon catheter includes an operating handle, an insertion tube, and a catheter electrode assembly; the insertion tube is connected to the distal end of the operating handle, and the catheter electrode assembly is any of the catheter electrode assemblies described above, and the catheter electrode assembly is connected to the distal end of the insertion tube.

[0034] When the electrode region is divided into at least two mutually insulated independent electrodes by a segmentation, the ablation host or mapping host is connected to the operating handle to transmit electrical energy between itself and the independent electrodes. When the balloon catheter is connected to the ablation host, the balloon catheter has an ablation working mode. In this ablation working mode, for a proximal electrode region and a corresponding distal electrode region arranged along the proximal and distal ends of the balloon body, the polarity of the connecting line connected to the proximal electrode region is opposite to that of the connecting line connected to the proximal electrode region. When the balloon catheter is connected to the mapping host, the balloon catheter has a mapping working mode. In this mapping working mode, the polarity of the connecting lines connected to electrodes located on both sides of the same segmentation region in the width direction is opposite.

[0035] The beneficial effects of this application are:

[0036] 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

[0037] Figure 1 is a schematic diagram of a structure of an embodiment of the balloon catheter in this application;

[0038] Figure 2 is a perspective view of the catheter electrode assembly in Figure 1;

[0039] Figure 3 is a two-dimensional view of the catheter electrode assembly in Figure 1;

[0040] Figure 4 is a frontal projection view of the catheter electrode assembly in Figure 1;

[0041] Figure 5 is a comparative schematic diagram of the front and back of a single flexible circuit board;

[0042] Figure 6 is a schematic diagram of an embodiment of the balloon catheter in this application during ablation in different postures;

[0043] Figure 7 is a schematic diagram of an embodiment of the balloon catheter in this application when it is in a contracted state;

[0044] Figure 8 is a perspective view of another embodiment of the catheter electrode assembly of the balloon catheter;

[0045] Figure 9 is the front view of Figure 8;

[0046] Figure 10 is a schematic diagram of the structure of one of the flexible circuit boards in Figure 8;

[0047] Figure 11 is a schematic diagram of one electrode configuration of the balloon catheter in Figure 8 under ablation working mode;

[0048] Figure 12 is a schematic diagram of one electrode configuration for the balloon catheter in Figure 8 in the mapping working mode.

[0049] List of feature names corresponding to the labels in the figure:

[0050] 100. Operating handle; 110. Connector;

[0051] 200. Insertion tube; 210. Center rod;

[0052] 300. Catheter electrode assembly;

[0053] 310. Sac-like body; 311. Equatorial region;

[0054] 320. Flexible circuit board;

[0055] 321, Insulating substrate; 3211, Through hole;

[0056] 322, Electrode sheet; 3221, Proximal electrode sheet; 3222, Distal electrode sheet; 3223, Segmented region; 3224, Independent electrode sheet;

[0057] 323, conductive line; 3231, solder pad;

[0058] 3241. Proximal portion; 3242. Distal portion; 3243. Connecting portion; 3244. Lead-out portion;

[0059] 324. Insulating materials;

[0060] 400. Target organization;

[0061] 500, electric field. Detailed Implementation

[0062] The present application will now be described in further detail with reference to the accompanying drawings and specific embodiments. Similar elements in different embodiments are referred to by related similar element reference numerals. In the following embodiments, many details are described to facilitate a better understanding of the present application. However, those skilled in the art will readily recognize that some features may be omitted in different situations, or may be replaced by other elements, materials, or methods. In some cases, certain operations related to the present application are not shown or described in the specification. This is to avoid obscuring the core parts of the present application with excessive description. For those skilled in the art, detailed description of these related operations is not necessary; they can fully understand the related operations based on the description in the specification and general technical knowledge in the art.

[0063] 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.

[0064] 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).

[0065] In some embodiments of this application, 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.

[0066] Examples of balloon catheters in this application:

[0067] 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.

[0068] 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.

[0069] 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.

[0070] In addition, those skilled in the art should know that the capsule 310 of the catheter electrode assembly 300 in this application 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, which facilitates entry and exit from the sheath.

[0071] Electrode sheets 322 can be located on flexible circuit boards 320. Flexible circuit boards 320 include an insulating substrate 321 and electrode sheets 322. The insulating substrate 321 is attached to the capsule 310, and the electrode sheets 322 are fixed to the insulating substrate 321. The number of flexible circuit boards 320 can be set as needed. For example, the capsule 310 in Figure 2 has six flexible circuit boards 320, each of which is strip-shaped, forming a circuit strip. Each flexible circuit board 320 is distributed circumferentially along the capsule 310, and the electrode sheets 322 on each flexible circuit board 320 form a group. The flexible circuit boards 320 can be fixed to the capsule by methods such as bonding or hot pressing, and can deform with the deformation of the capsule 310 to present the desired shape for contact with the target tissue 400. After the capsule 310 reaches its full state, it has a large outer surface area, which allows it to support electrodes with a large 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 and 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.

[0072] In some cases, the balloon catheter may also include a central rod 210 (as shown in Figure 4, where the balloon body is shown in a transparent state). The central rod 210 passes through the insertion tube 200 and enters the balloon body 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 balloon body 310. For example, pushing the central rod 210 distally can increase the axial (i.e., proximal-distal) dimension of the balloon body 310, while moving the central rod 210 proximally can decrease the axial dimension of the balloon body 310. Those skilled in the art will understand that in some embodiments, the central rod 210 may be a solid rod or a hollow rod. When a hollow rod is used, fluid can still be delivered through the central rod 210. In addition, in some other embodiments, the central rod 210 is not a necessary structure and may be omitted, with the shape of the balloon body 310 changed solely by inflating or deflated fluid.

[0073] 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.

[0074] It should be noted that the balloon catheter in the embodiments of this application 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 this application can be a mapping catheter for collecting electrophysiological signals of the target tissue 400.

[0075] Depending on the relative position between the balloon catheter and the target tissue 400, during operation, the balloon catheter may need to be in a state where its distal end is obliquely facing the target tissue 400 (as shown in Figure 6a), a state where its distal end is directly facing the target tissue 400 (as shown in Figure 6b), a state where it is laterally facing the target tissue 400 (as shown in Figure 6c), or a state where its 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 during balloon catheter contraction and the firmness of the electrode pads 322, the electrode pads are 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.

[0076] In the embodiments of the balloon catheter of this application, 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 balloon body 310 and a distal electrode 3222 disposed on the distal side of the balloon body 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 balloon body 310. The proximal electrode 3221 forms a proximal gradient region (as shown in Figure 5, located in the proximal region). The region between the two double-dotted lines on the end 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 a distal gradient region (as shown in Figure 5, the region between the two double-dotted lines on the distal electrode 3222), the distal gradient region gradually narrows from the middle of the proximal end of the capsule 310 towards the distal end of the capsule 310 along the circumferential direction.

[0077] 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 proximal-distal directions. The electric field coverage is comprehensive, and the proximal and distal gradient regions can adapt to the characteristics of the catheter electrode assembly 300 after filling, which has a large diameter in the proximal-distal direction and gradually decreases in diameter towards the proximal and distal ends. The electric field distribution is more uniform, which makes it easier for the balloon catheter to achieve ablation in a 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, and in conjunction with the proximal and distal gradient regions, when the catheter electrode assembly 300 contracts, as shown in Figure 7, the middle part of the catheter electrode assembly 300 in the proximal-distal direction can form higher structural stability by relying on the proximal electrode 3221 and the distal electrode 3222. The proximal and distal ends can form a smaller outer diameter, which facilitates the passage through the narrow sheath 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 at the same time achieves continuity of ablation and large-area coverage.

[0078] The two sides of the aforementioned proximal and distal gradient regions (i.e., the two sides along the circumference of the capsule 310) can be arranged symmetrically or asymmetrically. For example, one side in the width direction may be straight relative to the axis of the catheter electrode assembly 300, while the other side may 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.

[0079] In one embodiment, referring to Figures 2 to 5, both the proximal and distal ends of the proximal electrode 3221 are arc-shaped, with a proximal gradient region located between the two arcs; both the proximal and distal ends of the distal electrode 3222 are arc-shaped, with a distal gradient region located between the two arcs. The arc-shaped structure of 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.

[0080] Those skilled in the art will understand that the flexible circuit board 320 may include an insulating substrate 321 and an electrode sheet 322. The insulating substrate 321 is attached to the capsule 310, and the electrode sheet 322 is fixed to the insulating substrate 321. In one specific embodiment, referring to FIG5, the flexible circuit board 320 includes a proximal portion 3241 and a distal portion 3242. The proximal portion 3241 and the distal portion 3242 are respectively disposed on the proximal side and the distal side of the capsule 310. The shape of the insulating substrate 321 of the proximal portion 3241 is a gradient shape matching the proximal electrode sheet 3221; the shape of the insulating substrate 321 of the distal portion 3242 is a gradient shape matching the distal electrode sheet 3222. Matching the shapes of the proximal portion 3241 and the distal portion 3242 of the insulating substrate 321 with the electrode sheet 322 can further ensure the morphological stability of the catheter electrode assembly 300 during filling and shrinking. In another 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.

[0081] 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, thereby forming a concave portion at the distal end of the balloon body 310.

[0082] 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.

[0083] 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 a connecting portion 3243 connecting the proximal portion 3241 and the distal portion 3242. The connecting portion 3243 allows for 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 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.

[0084] In one specific embodiment, the 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 connecting portion 3243 helps reduce 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.

[0085] 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.

[0086] 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 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 shown as the dotted line in Figure 5. In addition, an insulating layer can be set on the conductive line 323 to achieve insulation of the wire. For example, the conductive line 323 with an outer insulating layer can be soldered to the back of the electrode sheet 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.

[0087] When performing ablation using the balloon catheter of this application, the balloon catheter can be connected to the ablation host. The ablation host connects the electrode 322 to the circuit of the corresponding polarity. For example, the electrode 322 on one flexible circuit board 320 is connected to the positive electrode, and the electrode 322 on the adjacent flexible circuit board 320 is connected to the negative electrode. This creates an electric field around the catheter electrode assembly 300 in both the proximal and distal directions. When in contact with the target tissue 400, the target tissue 400 is discharged, achieving pulsed electric field ablation.

[0088] 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 application has a gradient region that adapts to the proximal end of the balloon body 310, and the circuit strip includes a connecting portion 3243 connecting the proximal portion 3241 and the distal portion 3242. This facilitates control of the radial dimensions of the catheter electrode assembly 300 and improves the connection stability between the flexible circuit board 320 and the balloon body 310.

[0089] In some embodiments, electrodes on the balloon catheter can be used to record electrical signals from the heart for mapping, thereby helping doctors identify abnormal patterns of cardiac electrical activity, determine the cause of arrhythmias, and develop treatment plans.

[0090] For cardiac mapping, it is often necessary to consider how to place a greater number of electrodes on the balloon catheter to obtain more accurate detection results. For ablation of target tissue, in some cases it is necessary to increase the surface area of ​​the electrodes to avoid excessive energy concentration and damage to the electrode pads when transmitting ablation current, and to facilitate obtaining a more uniform electric field.

[0091] Please refer to Figures 8 to 12. Some embodiments of this application provide a catheter electrode assembly for a balloon catheter, addressing the technical problem of how to better integrate mapping and ablation functions in a balloon catheter. In these embodiments, the electrode regions on the catheter electrode assembly of the balloon catheter include a proximal electrode region located on the proximal side and a distal electrode region located on the distal side. The proximal and / or distal electrode regions are provided with segmentation areas, dividing the electrode regions into at least two mutually insulated independent electrodes. This allows the balloon catheter to have a greater number of electrodes when operating in mapping mode, thereby improving mapping accuracy. When operating in ablation mode, the proximal and distal electrode regions enable the formation of an ablation electric field across the entire balloon surface, resulting in a more uniform electric field and overall better integration of mapping and ablation functions.

[0092] To accommodate mapping and ablation, the capsule 310 has an equatorial portion 311 (as shown in Figure 9) with the largest diameter after filling, a proximal portion located on the proximal side of the equatorial portion 311, and a distal portion located on the distal side of the equatorial portion 311. The diameter of the capsule 310 refers to its diameter perpendicular to the proximal-distal direction. The diameter of the capsule 310 gradually decreases from the equatorial portion 311 towards the proximal and distal ends of the capsule 310, respectively. Simultaneously, the exposed portion of the electrode pads 322 on the catheter electrode assembly 300 forms an electrode region. The electrode region formed by the electrode pads 322 on the catheter electrode assembly 300 includes a proximal electrode region located on the proximal portion and a distal electrode region located on the distal portion. A dividing region 3223 is provided on the proximal and / or distal electrode regions, dividing the electrode region into at least two mutually insulated independent electrodes 3224.

[0093] It should be noted that in some embodiments, the proximal and distal portions can be symmetrically arranged on both sides of the equatorial portion 311 in the proximal-distal direction, or they can be arranged in an asymmetrical form. For example, the axial dimension of the distal portion can be greater than or less than the axial dimension of the proximal portion.

[0094] The aforementioned segmented region 3223 can be formed by the gap between spaced independent electrode sheets 3224, which are formed on the insulating substrate 321 at certain intervals. Alternatively, the aforementioned segmented region 3223 can be formed by a single electrode sheet through a local elimination method, such as by etching or by laser.

[0095] To improve the insulation effect of the independent electrodes 3224 on both sides of the segmentation region 3223, in some embodiments, the conduit electrode assembly 300 includes an insulating material 324. The insulating material 324 can cover the segmentation region 3223, and the entire circumferential edge of the independent electrodes 3224 on both sides of the segmentation region 3223 can also be covered by the insulating material 324. The insulating material 324 can be a coating layer, a printed layer, etc., and the material can be solder resist ink, photoresist, polyimide, acrylic resin, silicon dioxide, etc. In some exemplary embodiments, the insulating material 324 can also be an insulating film, which can be bonded to the insulating volume and / or electrode area by means of bonding, hot pressing, etc.

[0096] The segmentation region 3223 is arranged along the surface contour of the catheter electrode assembly 300. For example, for a capsule 310 with a curved surface contour, the segmentation region 3223 may be an arcuate structure. As an illustrative example, for a capsule 310 whose surface contour includes a planar portion, the segmentation region 3223 located on the planar portion may be a straight line. The shape of the segmentation region 3223 is not limited; for example, it may be a straight line, a sine wave, a triangular wave, a parabola, etc. In some embodiments, referring to Figures 8 to 10, the segmentation region 3223 may extend in the proximal-distal direction, such that the individual electrode patches 3224 of the corresponding electrode regions are spaced apart circumferentially along the capsule 310. In some other embodiments, the segmentation region 3223 may also extend in a direction intersecting the proximal-distal direction, such that the individual electrode patches 3224 of the corresponding electrode regions are spaced apart in the proximal-distal direction. Those skilled in the art will understand that the intersection at this point does not necessarily mean perpendicularity. For example, the extending direction of the segmentation region 3223 can form an angle of 15°, 30°, 45°, 60°, etc., with the proximal-distal direction. In addition, in some other embodiments, segmentation regions 3223 extending along the proximal-distal direction and segmentation regions 3223 extending along a direction intersecting the proximal-distal direction can be provided simultaneously, thus forming an alternating arrangement of segmentation regions 3223. The number of segmentation regions 3223 can also be increased or decreased as needed.

[0097] In one embodiment, the catheter electrode assembly 300 includes at least two flexible circuit boards 320 distributed circumferentially along the capsule 310. The flexible circuit boards 320 are attached to the capsule 310, and the electrode regions are disposed on the flexible circuit boards 320. The flexible circuit board 320 includes a proximal portion 3241, a distal portion 3242, and a connecting portion 3243 connecting the proximal portion 3241 and the distal portion 3242. The proximal electrode region is disposed on the proximal portion 3241, and the distal electrode region is disposed on the distal portion 3242. By using the flexible circuit board 320 with the proximal portion 3241, the distal portion 3242, and the connecting portion 3243, the relative positions of the proximal electrode region and the distal electrode region can be easily located, which is beneficial for ensuring mapping accuracy or ablation accuracy.

[0098] In one specific embodiment, the connecting portion 3243 can be made smaller in circumferential dimension along the capsule 310 than the proximal portion 3241 and the distal portion 3242. Since the diameter of the middle part of the capsule 310 in the proximal-distal direction changes significantly during the inflation and deflation of the catheter electrode assembly 300, the thinner connecting portion helps reduce the stress between the flexible circuit board 320 and the capsule 310 during inflation and deflation, thus helping to prevent the flexible circuit board 320 from peeling off. In addition, by providing the above-mentioned thin strip-shaped connecting portion 3243, the catheter electrode assembly 300 can form a cylindrical shape with high axial strength when the capsule 310 is in the deflated state. When the surgeon pushes the catheter electrode assembly 300 into the sheath, it helps the catheter electrode assembly 300 to always maintain a cylindrical shape, preventing abnormal bulging of the catheter electrode assembly 300 in the sheath due to a long pushing path, and preventing the electrode pad 322 from scraping the inner wall of the sheath.

[0099] The width of the segmentation region 3223 is smaller than the dimension of the independent electrode 3224 divided by the segmentation region 3223 along the width direction of the segmentation region 3223, which is beneficial for achieving a greater number of independent electrode 3224. In one specific embodiment, the width of the segmentation region 3223 can be no less than 0.3mm, for example, 0.5mm, so that adjacent independent electrode 3224 form a corresponding size interval, which is beneficial for better ensuring the insulation strength between the independent electrode 3224 and improving the reliability of the product.

[0100] In some embodiments, the proximal electrode region forms a proximal gradient structure, the size of which gradually narrows from the distal side to the proximal side along the circumference of the capsule 310; the distal electrode region forms a distal gradient structure, the size of which gradually narrows from the proximal side to the distal side along the circumference of the capsule 310; the segmentation region 3223 extends along the proximal-distal direction, dividing the electrode region into two symmetrically arranged independent electrodes 3224, which is beneficial to improving the accuracy of data acquisition, facilitating the formation of a regular ablation electric field 500, and ensuring the morphological stability of the catheter electrode assembly 300 during filling and contraction. In some other embodiments, the two independent electrodes 3224 divided by the segmentation region 3223 extending along the proximal-distal direction may also be an asymmetrical structure with differences in shape and / or size.

[0101] The aforementioned electrode sheet 322 includes a proximal electrode sheet and a distal electrode sheet, with the proximal electrode region and the distal electrode region formed by exposed areas on the proximal electrode sheet and the distal electrode sheet, respectively. It should be noted that the electrode sheet 322 may include an electrode sheet 322 body and a coating disposed on the surface of the electrode sheet 322 body away from the capsule 310.

[0102] In addition, the proximal and distal portions of the capsule 310 can be symmetrically arranged on both sides of the equatorial portion 311 in the proximal-distal direction, and the proximal and distal regions of the electrode region can also be symmetrically arranged on both sides of the equatorial portion 311 in the proximal-distal direction, which is also beneficial to improving the uniformity of the electric field.

[0103] To achieve ablation or mapping, different independent electrodes 3224 need to be connected to circuits of corresponding polarities. Therefore, each independent electrode 3224 is connected to its own conductive line 323, which is used to transmit electrical energy to the independent electrode 3224. The conductive connection form of the conductive line 323 is not limited. For example, in some embodiments, referring to Figure 10, each independent electrode 3224 on the same flexible circuit board 320 has a pad 3231 on the side near the capsule 310. Wires can be soldered onto the pads 3231. After passing through the capsule 310, the wires enter the insertion tube 200 through the inside of the capsule 310, and then lead to the operating handle 100. They are then connected to the ablation host or mapping host through the connector 110 on the operating handle 100, forming a conductive line 323. The aforementioned pads 3231 can be located on the side of the insulating substrate 321 away from the electrode 322, and the conductive connection with the electrode 322 is achieved through a conductive structure spanning both sides of the thickness direction of the insulating substrate 321. The conductive structure can adopt existing methods in the field of flexible circuit boards, and the specific structural form is not limited. For example, it can be a via through the insulating substrate 321, i.e., a metallized via. Alternatively, a conductive layer can be provided on the lateral surface where the edge of the insulating substrate 321 intersects with the surface of the insulating substrate 321, relying on the conductive layer to achieve conductive connection between the front and back sides of the insulating substrate 321. Furthermore, in some embodiments, corresponding traces can be laid on the flexible circuit board 320, and each independent electrode 3224 is connected to the corresponding trace. The traces can be led to the connection portion near the end of the insulating substrate 321, and the connection portion can be provided with pads for trace connection, on which wires can be soldered. The traces can be formed using molding methods commonly used in the field of flexible circuit boards, such as etching. An embodiment of the catheter electrode assembly of the balloon catheter in this application:

[0104] 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.

[0105] Embodiments of the catheter system in this application:

[0106] The catheter system, including the balloon catheter in any of the above embodiments, also includes an ablation host and / or a mapping host. The ablation host or mapping host is connected to the operating handle 100 to transmit electrical energy between itself and the independent electrode 3224. It should be noted that the working principles of the ablation host and the mapping host can be found in existing products in related technologies, and will not be elaborated here. Accordingly, the balloon catheter has an ablation working mode and a mapping working mode, and the independent electrode 3224 has different polarity configurations in each mode.

[0107] Those skilled in the art will understand that, in the ablation mode, a pulsed electric field of 500° can be formed between the first and second electrodes with opposite polarities. Pulsed electric field ablation can be achieved by directly applying a high-voltage pulse to the patient's tissue using both electrodes (positive and negative). In the mapping mode, the electrodes of the balloon catheter can be placed against the heart chamber wall to acquire electrocardiogram (ECG) signals. Simultaneously, the position information of the electrodes is obtained through a positioning sensor. These two methods are fused to reconstruct the three-dimensional electroanatomical structure and acquire mapping signals. Mapping signals can be acquired using unipolar or bipolar signal acquisition. Unipolar signal acquisition refers to measuring the voltage difference between a reference point (usually a fixed position on the body, such as the right leg drive or a fixed electrode) and a moving electrode in the heart. This method can capture electrical signals from various parts of the heart and provide extensive information about cardiac electrical activity. Because unipolar signals involve a common reference point, they can provide information about cardiac electrical activity relative to that reference point, which helps identify differences in electrical activity between different regions of the heart. Bipolar acquisition refers to measuring the voltage difference between two adjacent electrodes inside the heart. This method is commonly used in interventional cardiology procedures such as catheter ablation because it can more accurately locate sources of electrical activity within the heart. Bipolar acquisition has a localized nature and usually has higher spatial resolution, making it more suitable for detecting changes in electrical activity over small areas, such as in identifying and mapping specific arrhythmias.

[0108] In some embodiments, when the balloon catheter is connected to the ablation host, the balloon catheter has an ablation working mode. In the ablation working mode, referring to FIG11, for a proximal electrode region and a corresponding distal electrode region arranged along the proximal and distal ends of the balloon body 310, the polarity of the conductive line 323 connected to the proximal electrode region is opposite to that of the conductive line 323 connected to the proximal electrode region, which can establish an electric field 500 between the proximal and distal portions of the balloon body 310.

[0109] When the balloon catheter is connected to the mapping host, the balloon catheter has a mapping working mode. In the mapping working mode, please refer to Figure 12. The polarities of the conductive lines 323 connected to the independent electrode plates 3224 located on both sides of the width direction of the same segment 3223 are opposite, which can establish an electric field 500 between the independent electrode plates 3224 separated by the same segment 3223.

[0110] By relying on the catheter electrode assembly 300 in the embodiments of this application, through the setting of the proximal electrode region and the distal electrode region of the electrode region, combined with the segmentation area 3223 on the electrode region, the balloon catheter can better adapt to mapping by relying on more independent electrodes 3224, and can form a larger electric field 500 for ablation, better adapt to ablation, thereby being more compatible with mapping and ablation.

[0111] The above examples illustrate this application only to aid understanding and are not intended to limit its scope. Those skilled in the art to which this application pertains can make various simple deductions, modifications, or substitutions based on the ideas presented.

Claims

1. 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 circuit strips, and the number of circuit strips is at least two. The circuit strips are distributed circumferentially along the capsule, and the circuit strips include connecting portions connecting 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. The catheter electrode assembly as claimed in claim 1, characterized in that, The electrode pads form electrode regions exposed on the surface of the catheter electrode assembly, and the electrode regions include a proximal electrode region located on the proximal side of the capsule and a distal electrode region located on the distal side of the capsule. The proximal electrode region is provided with a segmentation region, which divides the proximal electrode region into at least two mutually insulated independent electrodes; and / or, the distal electrode region is provided with a segmentation region, which divides the distal electrode region into at least two mutually insulated independent electrodes.

11. The catheter electrode assembly as claimed in claim 10, characterized in that, The segmentation region is arranged along the surface contour of the conduit electrode assembly; The segmentation region extends along the proximal-distal direction, and the segmentation region causes the electrodes of the corresponding electrode regions to be arranged at intervals along the circumferential direction of the capsule; or, the segmentation region extends along the surface of the catheter electrode assembly, and the extension direction intersects the proximal-distal direction, so that the electrodes of the corresponding electrode regions are arranged at intervals along the proximal-distal direction.

12. The catheter electrode assembly as claimed in claim 11, characterized in that, The proximal and distal ends of the proximal electrode region are both arc-shaped, and / or the proximal and distal ends of the distal electrode region are both arc-shaped; the segmentation region passes through the middle of the arc length of the corresponding arc.

13. The catheter electrode assembly according to any one of claims 10 to 12, characterized in that, The width of the segmented region is smaller than the dimension of the independent electrode sheet segmented by the segmented region along the width direction of the segmented region.

14. The catheter electrode assembly as claimed in claim 13, characterized in that, The width of the segmented area is not less than 0.3 mm.

15. The catheter electrode assembly according to any one of claims 10 to 12, characterized in that, The catheter electrode assembly includes an insulating material, the entire circumference of the individual electrode is covered by the insulating material, and / or the segmented area is covered by the insulating material.

16. 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 15, and the catheter electrode assembly is connected to the distal end of the insertion tube.

17. A catheter system, characterized in that, This includes balloon catheters, as well as ablation and / or mapping units; The balloon catheter includes an operating handle, an insertion tube, and a catheter electrode assembly; the insertion tube is connected to the distal end of the operating handle, and the catheter electrode assembly is the catheter electrode assembly according to any one of claims 10 to 15, wherein the catheter electrode assembly is connected to the distal end of the insertion tube. The ablation host or mapping host is connected to the operating handle to transmit electrical energy between itself and the independent electrode. When the balloon catheter is connected to the ablation host, the balloon catheter has an ablation working mode. In the ablation working mode, for a proximal electrode region and a corresponding distal electrode region arranged along the proximal and distal ends of the balloon body, the polarity of the connection line connected to the proximal electrode region is opposite to the polarity of the connection line connected to the proximal electrode region. When the balloon catheter is connected to the mapping host, the balloon catheter has a mapping working mode. In the mapping working mode, the polarities of the connecting lines connected to the electrodes located on both sides of the width direction of the same segment are opposite.

Images