Balloon catheter flexible circuit board, balloon electrode assembly, and balloon ablation catheter

Abstract

The present invention relates to the field of ablation catheters, in particular to a balloon catheter flexible circuit board, a balloon electrode assembly, and a balloon ablation catheter. The balloon catheter flexible circuit board comprises: an insulating substrate, one side of the insulating substrate in the thickness direction being provided with an adhesive side surface, and the adhesive side surface being adhered and fixed to a balloon of a balloon electrode assembly; and an electrode sheet, the electrode sheet being provided on the side of the insulating substrate facing away from the adhesive side surface. A glue accommodation space is distributed on the insulating substrate, the glue accommodation space having an opening on the adhesive side surface, and the opening being used for introducing a glue for adhering the balloon catheter flexible circuit board; at least part of the glue accommodation space has a bottom wall, the bottom wall enabling the side of the glue accommodation space away from the opening to form a closed structure. The present invention mainly solves the technical problem that flexible circuit boards of balloon ablation catheters are prone to peeling off from balloon bodies.

Description

Balloon catheter flexible circuit board, balloon electrode assembly and balloon ablation catheter Technical Field

[0001] This invention relates to the field of ablation catheters, specifically to a balloon catheter flexible circuit board, a balloon electrode assembly, and a balloon ablation catheter. Background Technology

[0002] Globally, the patient population with tachyarrhythmias is large, and this number is expected to continue to grow rapidly. Among various treatment methods in the medical field, catheter-based focal ablation therapy is prioritized and recommended by multiple domestic and international guidelines due to its high success rate, good safety profile, and minimally invasive nature. Ablation catheters are further categorized based on the source of ablation energy, including radiofrequency, cryotherapy, and pulsed ablation. Currently, the latest cutting-edge technology in the industry is pulsed electric field ablation (PFA), and balloon-type pulsed electric field ablation products represent an important direction for the development of this technology.

[0003] The balloon electrode assembly of a balloon catheter includes a balloon body and a flexible circuit board, which is typically bonded to the outer surface of the balloon body. During use, the balloon will inflate and collapse, thus posing a risk that the flexible circuit board may peel off from the surface of the balloon body, which could affect the ablation effect and product quality. Summary of the Invention

[0004] This invention primarily addresses the technical problem that the flexible circuit board of a balloon ablation catheter is easily peeled off from the balloon body.

[0005] In a first aspect, the present invention provides a flexible circuit board for balloon catheters.

[0006] The flexible circuit board for the balloon catheter includes:

[0007] An insulating substrate, wherein one side of the insulating substrate in the thickness direction has an adhesive side surface, the adhesive side surface being used for bonding and fixing to the balloon of the balloon electrode assembly;

[0008] And an electrode sheet, the electrode sheet being disposed on the side of the insulating substrate opposite to the bonding side;

[0009] The insulating substrate has distributed colloid-containing spaces, each colloid-containing space forming an opening on the bonding side, the opening allowing the adhesive for bonding the flexible circuit board of the balloon catheter to enter; at least a portion of the colloid-containing spaces have a bottom wall, the bottom wall causing the side of the colloid-containing space away from the opening to form a closed structure.

[0010] In one embodiment, at least a portion of the colloid-containing space is formed by pores provided on the insulating substrate.

[0011] In one embodiment, at least a portion of the holes are blind holes, and the depth of the blind holes is 0.2 to 0.8 times the thickness of the insulating substrate.

[0012] In one embodiment, the minimum spacing between any two holes is 0.5 to 5 times the side length or diameter of the hole.

[0013] In one embodiment, at least some of the holes are circular, square, rhomboid, regular pentagonal, or regular hexagonal in shape.

[0014] In one embodiment, the diameter of the opening is 0.02 mm to 0.2 mm.

[0015] Secondly, the present invention provides a balloon electrode assembly.

[0016] The balloon electrode assembly includes:

[0017] A balloon, which is collapsible and inflatable;

[0018] And a flexible circuit board, which is fixedly attached to the outer surface of the balloon and bonded to the balloon; the flexible circuit board is the balloon catheter flexible circuit board described in any of the above claims.

[0019] Thirdly, the present invention provides a balloon ablation catheter.

[0020] Balloon ablation catheters include:

[0021] handle;

[0022] An insertion tube is connected to the distal end of the handle;

[0023] The balloon electrode assembly is fixed to the distal end of the insertion tube. The balloon electrode assembly includes a balloon and a flexible circuit board. The balloon is collapsible and inflatable. The flexible circuit board is fixedly attached to the outer surface of the balloon and is bonded to the balloon. The flexible circuit board is a flexible circuit board for balloon catheters as described above.

[0024] The beneficial effects of this invention are:

[0025] In an embodiment of the present invention, the insulating substrate of the flexible circuit board of the balloon catheter has an adhesive side, and an adhesive receiving space is provided on the adhesive side. The adhesive receiving space can form an opening on the adhesive side. When the flexible circuit board is bonded to the balloon through the adhesive side of the insulating substrate, the adhesive used to bond the flexible circuit board of the balloon catheter can enter the adhesive receiving space from the opening. The sidewall of the adhesive receiving space can contact the adhesive, resulting in a larger bonding area. After the adhesive in the adhesive receiving space is cured, the direction of the adhesive force between the sidewall of the adhesive receiving space and the adhesive can form an angle with the direction in which the flexible circuit board is peeled off from the balloon, thereby improving the bonding strength and helping to prevent the flexible circuit board of the balloon ablation catheter from peeling off from the balloon body, thus solving the technical problem that the flexible circuit board of the balloon ablation catheter is easily peeled off from the balloon body. Attached Figure Description

[0026] Figure 1 is a schematic diagram of a structure of an embodiment of the balloon electrode assembly of the present invention;

[0027] Figure 2 is a magnified view of a portion of Figure 1;

[0028] Figure 3 is a schematic diagram of the insulating substrate of the flexible circuit board in Figure 1;

[0029] Figure 4 is a magnified view of part A in Figure 3;

[0030] Figure 5 is a schematic diagram of the layered structure of an embodiment of the flexible circuit board for balloon catheters;

[0031] Figure 6 is a schematic diagram of the insulating substrate in another embodiment of the flexible circuit board;

[0032] Figure 7 is a schematic diagram of the insulating substrate in another embodiment of the flexible circuit board.

[0033] List of feature names corresponding to the labels in the figure:

[0034] 100. Balloon;

[0035] 200. Flexible circuit board; 210. Insulating substrate; 211. Adhesive side; 212. Colloid containment space; 213. Complete area; 220. Electrode sheet; 230. Protective layer;

[0036] 300. Proximal connector;

[0037] 400. Remote connector. Detailed Implementation

[0038] 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 associated 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.

[0039] 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.

[0040] 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).

[0041] The terms "proximal" and "distal" used in this article are conventional medical terms. For the instrument to be operated on, the proximal end is the end closer to the operator, and the distal end is the end farther from the operator. It is usually the end that enters the patient's body first. The proximal and distal ends can be referred to in Figure 1 for their orientation.

[0042] In this invention, the insulating substrate 210 of the flexible circuit board 200 of the balloon catheter is provided with a colloid receiving space 212. The colloid receiving space 212 forms an opening on the bonding side 211 of the insulating substrate 210. When the insulating substrate 210 is bonded to the balloon 100, the adhesive used to bond and fix the insulating substrate 210 can enter the colloid receiving space 212 through the opening 2121, which effectively increases the bonding area. The colloid formed after the adhesive has cured can bond with the side wall of the colloid receiving space 212 and can also change the direction of the bonding force at the side wall of the colloid receiving space 212. This is beneficial to improve the bonding effect and prevent the insulating substrate 210 from peeling off from the balloon 100.

[0043] Meanwhile, the colloidal accommodating space 212 distributed on the insulating substrate 210 can increase the flexibility of the insulating substrate 210, making it easier for the flexible circuit board 200 to deform accordingly with the collapse and inflation of the balloon 100, which helps to reduce the deformation inconsistency between the flexible circuit board 200 and the balloon 100, thereby better preventing the flexible circuit board 200 from peeling off from the balloon 100.

[0044] Embodiments of the balloon electrode assembly in this invention:

[0045] Please refer to Figures 1 and 2. In one embodiment, the balloon electrode assembly includes a balloon 100, a flexible circuit board 200, a proximal connector 300, and a distal connector 400.

[0046] Those skilled in the art will understand that the balloon 100 can be made of polymer materials such as nylon, PEBAX, PET, and polyurethane, and is flexible, capable of being inflated by filling with liquid or gas, and collapsing when the liquid or gas is expelled.

[0047] The proximal connector 300 is located at the proximal end of the balloon 100, and can be fixedly connected to the balloon 100 and the distal end of the insertion tube of the balloon ablation catheter. The proximal connector 300 can be a tube structure, and an inflation channel can be provided within the insertion tube and the proximal connector 300, for example, a channel formed by an inner lumen or a corresponding tubing. The inflation channel can realize the inflation and deflation of liquid or gas, thereby realizing the inflation and collapse of the balloon 100.

[0048] The distal connector 400 is located at the distal end of the balloon 100, allowing for distal connection of the balloon 100 and forming a channel for the guidewire to pass through. Those skilled in the art will understand that the guidewire provides auxiliary guidance within the vascular system, helping the ablation catheter navigate winding vascular paths to ultimately locate the specific cardiac structure or region causing the arrhythmia. In use, the tip of the guidewire often extends beyond the catheter, allowing the operator to guide the entire ablation device by controlling the guidewire. Once the guidewire is in place, the ablation catheter advances along it, ensuring accurate delivery to the treatment area.

[0049] It should be noted that in some other embodiments, the distal connector 400 may be located inside the balloon 100, the distal connector 400 may be omitted from the balloon electrode assembly, and the perforation for the guidewire to pass through the distal end of the balloon electrode assembly may also be omitted.

[0050] The balloon 100, proximal connector 300 and distal connector 400 of the balloon electrode assembly can adopt existing structures in related technologies, and will not be described further here.

[0051] The flexible circuit board 200 of the balloon electrode assembly is attached to the outer surface of the balloon 100, and the flexible circuit board 200 is bonded and fixed to the balloon 100. The flexible circuit board 200 includes an insulating substrate 210 and an electrode sheet 220. The electrode sheet 220 has an exposed portion exposed to the outside of the flexible circuit board 200, which can form an ablation electric field to achieve the corresponding ablation function.

[0052] Figure 1 shows only one flexible circuit board 200, and the balloon 100 is shown in a transparent state, only illustrating the outer contour line in the inflated state. The adhesive side of the flexible circuit board 200 faces outward from the paper, and the flexible circuit board 200 shown in Figure 1 is located on the side of the balloon 100 away from the paper. It should be noted that the specific number of flexible circuit boards 200 can be determined according to the ablation requirements, for example, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 or more. In addition, the arrangement position and area of ​​the flexible circuit boards 200 on the balloon 100 are not limited. For example, in the embodiment shown in Figure 1, the distal end of the flexible circuit board 200 is located at the distal end of the balloon 100, and the proximal end of the flexible circuit board 200 extends to the proximal connector 300. However, those skilled in the art should know that in some embodiments, the flexible circuit board 200 may also be disposed on the distal side of the balloon 100 or across the axial middle of the balloon 100 and biased towards the distal side of the balloon 100, or disposed on the proximal side of the balloon 100 or across the axial middle of the balloon 100 and biased towards the proximal side of the balloon 100; in addition, in some other embodiments, a portion of the flexible circuit board 200 may be disposed on the distal side of the balloon 100 or across the axial middle of the balloon 100 and biased towards the distal side of the balloon 100, while another portion of the flexible circuit board 200 may be disposed on the proximal side of the balloon 100 or across the axial middle of the balloon 100 and biased towards the proximal side of the balloon 100.

[0053] Those skilled in the art will understand that the insulating substrate 210 of the flexible circuit board 200 is compliant, providing support for the circuit and maintaining its bending and torsional flexibility and reliability. The insulating substrate can be made of polyimide (PI), polyethylene terephthalate (PET), etc.

[0054] The electrode sheet 220 is attached to the insulating substrate 210. The electrode occupies a certain surface area on the insulating substrate 210. The size and shape of the electrode sheet 220 can be designed according to the ablation requirements, and existing structures in related technologies can be used. Furthermore, the number of electrodes on the same insulating substrate 210 can be one or more. The electrode sheet 220 can be made of platinum-iridium alloy, stainless steel alloy, copper, etc. Those skilled in the art should understand that the bonding method of the electrode sheet 220 to the insulating substrate 210 is not limited; for example, it can be bonded to the insulating substrate 210 by means of bonding, etching, plating, etc.

[0055] When manufacturing the flexible circuit board 200, the electrode sheet 220 can be directly bonded and fixed to the insulating substrate 210, forming an exposed discharge surface. In some other embodiments, please refer to Figure 5, a protective layer 230 can also be provided on the side of the electrode sheet 220 away from the insulating substrate 210, which serves to fix and protect the electrode. Of course, a clearance opening can be provided on the protective layer 230 to expose the electrode. The material of the protective layer 230 can be the same as that of the insulating substrate 210, such as polyimide. It should be noted that Figure 5 is not used to show the actual product form of the flexible circuit board 200, but to illustrate a possible layered form of the flexible circuit board 200. The protective layer 230 is only shown as an illustration. The gap between the protective layer 230 and the insulating substrate 210 can be tightly attached and fixed to the insulating substrate 210 by bonding, hot pressing, or other methods when molding the flexible circuit board 200.

[0056] Referring to Figures 4 and 5, the insulating substrate 210 has an adhesive side surface 211 on one side in the thickness direction. The adhesive side surface 211 is used for bonding and fixing to the balloon 100 of the balloon electrode assembly. The electrode sheet 220 is disposed on the side of the insulating substrate 210 facing away from the adhesive side surface 211. As some examples, the adhesive between the flexible circuit and the balloon 100 can be polyurethane adhesive, UV adhesive, epoxy resin, acrylic resin, etc., and the adhesive between the electrode and the insulating substrate 210 can also be polyurethane adhesive, UV adhesive, epoxy resin, acrylic resin, etc.

[0057] When using the balloon electrode assembly, the balloon 100 needs to pass through the sheath in a collapsed state and reach the target location guided by the sheath. During ablation, liquid or gas is injected into the balloon 100 to inflate it so that the electrode pad 220 can better adhere to the tissue to be ablated. In addition, after ablation is completed, the balloon 100 needs to collapse again to return to the sheath.

[0058] Since balloon catheters typically use a pre-inserted sheath within a blood vessel as the interventional channel, and the sheath diameter is limited—an excessively large diameter can increase patient discomfort and restrict application scenarios, while an excessively small diameter makes it difficult for the balloon catheter to pass through smoothly—the industry standard allows for selection of sheath inner diameters as needed, such as 6Fr-24Fr. Those skilled in the art should know that the diameter of sheaths used in cardiac ablation surgery is commonly measured in "French" (Fr), where 3Fr = 1mm. For example, a 12Fr sheath diameter is approximately 4mm. During the aforementioned use, the flexible circuit board 200 changes shape as the balloon 100 inflates and collapses. Due to the significant shape change of the balloon 100, the flexible circuit board 200 is prone to detaching from the balloon 100, which is detrimental to ensuring the reliability of the balloon ablation catheter product and the surgical outcome.

[0059] In order to more reliably fix the flexible circuit board 200 to the balloon 100, in one embodiment, the insulating substrate 210 has an adhesive receiving space 212 distributed thereon, and the adhesive receiving space 212 has an opening on the bonding side 211 for the adhesive liquid used to bond the flexible circuit board 200 of the balloon catheter to enter.

[0060] By setting up the colloid containing space 212, when the flexible circuit board 200 is bonded to the balloon 100, the adhesive enters the colloid containing space 212 and cures. The peeling direction between the sidewall of the colloid containing space 212 and the colloid is along the normal of the corresponding part of the sidewall. This direction has an angle with the direction in which the flexible circuit board 200 is peeled from the balloon 100, which is beneficial to improving the bonding effect. At the same time, the colloid can form a larger bonding area, which is also beneficial to improving the bonding effect.

[0061] The aforementioned colloid-containing space 212 can be formed by a hole provided on the insulating substrate 210. In some embodiments, at least a portion of the colloid-containing space 212 may have a bottom wall, such that the side of the colloid-containing space 212 away from the opening forms a closed structure. For example, the hole may be a blind hole, the bottom wall of which forms a closed structure.

[0062] In some other embodiments, the holes provided on the insulating substrate 210 can also be through holes. When using through holes, both ends of the through hole can be provided with openings; in addition, a sealing structure can be provided on the side of the through hole near the electrode sheet to achieve closure, or closure can be achieved by relying on the electrode sheet. In some other embodiments, the colloid receiving space 212 can also adopt other structures, such as a groove with a curved inner wall surface. In some specific embodiments, the groove can be a spherical groove, an ellipsoidal groove, a parabolic groove, etc.

[0063] In some specific embodiments, the diameter of the blind hole can be from 0.02 mm to 0.2 mm, which facilitates the filling of adhesive while avoiding significant impact on the structure of the flexible circuit board 200.

[0064] Those skilled in the art will understand that the insulating substrate 210 needs to possess certain strength and toughness so that the flexible circuit board 200 can maintain a relatively stable shape and recover after deformation. Therefore, for the colloid-containing space 212 in the form of a blind via, in some embodiments, the depth of the blind via is 0.2 to 0.8 times the thickness of the insulating substrate 210. Furthermore, the minimum spacing between any two holes can be 0.5 to 5 times the side length or diameter of the hole. Those skilled in the art will understand that the aforementioned minimum spacing can be the shortest line length among all lines connecting any point on the outline of one hole to any point on the outline of another hole.

[0065] Of course, in some other embodiments, whether it is a blind hole type colloid containing space 212 or a through hole type colloid containing space 212, the strength and toughness of the insulating substrate 210 can be guaranteed by setting parameters such as the thickness of the insulating substrate 210, the diameter of the hole, and the minimum spacing size of the hole.

[0066] Referring to Figures 1 to 5, in one specific embodiment, the hole on the insulating substrate 210 is circular in shape to facilitate design and manufacturing. In some other embodiments, the shape of the hole can be replaced with other shapes, including but not limited to square (see Figure 6), rhombus, regular pentagon, or regular hexagon (see Figure 7). Those skilled in the art will understand that two or more openings of different shapes can also be provided on the insulating substrate 210 simultaneously.

[0067] Without affecting other functional designs, the colloid-containing space 212 can be located at any position on the adhesive side 211 of the insulating substrate 210. In some embodiments, to better improve the bonding and fixing effect, at least a portion of the colloid-containing space 212 can be located on the side of the electrode sheet 220 close to the adhesive side 211. However, as an example, in some embodiments, the balloon 100 and the flexible circuit board 200 may be provided with infusion holes for the infusion fluid to pass through. To avoid affecting the infusion holes, the colloid-containing space 212 can be positioned away from the area corresponding to the infusion holes, for example, by maintaining a set distance from the infusion holes.

[0068] In some embodiments, at least a portion of the edge of the insulating substrate 210 is a complete region 213 that does not include the colloid-accommodating space 212, and the colloid-accommodating spaces 212 are distributed in all other regions of the insulating substrate 210 except for the complete region 213. Providing the complete region 213 helps ensure the structural strength of the edge portion of the insulating substrate 210 and prevents the flexible circuit board 200 from cracking at the edge due to the presence of the colloid-accommodating space 212. Referring to FIG3, in one specific embodiment, the complete region 213 is provided on each side edge of the flexible circuit board 200. In some other embodiments, the complete region 213 may be provided only at a portion of the edge of the flexible circuit board 200, for example, only on both sides of the flexible circuit board 200 in the width direction.

[0069] By providing a colloid-containing space 212 on the insulating substrate 210 of the flexible circuit board 200, the adhesion between the insulating substrate 210 and the balloon 100 can be increased, better preventing delamination between the insulating substrate 210 and the balloon 100 and improving product reliability. Simultaneously, the colloid-containing space 212 can reduce the structural rigidity of the insulating substrate 210 and improve its compliance, allowing the balloon 100 and the flexible circuit board 200 to fit more closely during assembly. This facilitates manufacturing and improves the overall compliance of the balloon 100, enabling the product to better conform to lesions at different locations during surgery, thus facilitating the achievement of the desired ablation effect.

[0070] An embodiment of the flexible circuit board for balloon catheters in this invention:

[0071] The structure of the flexible circuit board of the balloon catheter is the same as that of the flexible circuit board 200 in any embodiment of the balloon electrode assembly described above, and will not be described again here.

[0072] Examples of balloon ablation catheters in this invention:

[0073] A balloon ablation catheter includes a handle, an insertion tube, and a balloon electrode assembly. The insertion tube is connected to the distal end of the handle, and the balloon electrode assembly is fixed to the distal end of the insertion tube. The balloon electrode assembly includes a balloon 100 and a flexible circuit board 200. The balloon 100 is collapsible and inflatable, and the flexible circuit board 200 is fixedly attached to the outer surface of the balloon 100. The flexible circuit board 200 is bonded and fixed to the balloon 100. The flexible circuit board 200 is any of the balloon catheter flexible circuit boards 200 described above.

[0074] 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 flexible circuit board for a balloon catheter, characterized in that, include: An insulating substrate, wherein one side of the insulating substrate in the thickness direction has an adhesive side surface, the adhesive side surface being used for bonding and fixing to the balloon of the balloon electrode assembly; And an electrode sheet, the electrode sheet being disposed on the side of the insulating substrate opposite to the bonding side; The insulating substrate has distributed colloid-containing spaces, each colloid-containing space forming an opening on the bonding side, the opening allowing the adhesive for bonding the flexible circuit board of the balloon catheter to enter; at least a portion of the colloid-containing spaces have a bottom wall, the bottom wall causing the side of the colloid-containing space away from the opening to form a closed structure.

2. The flexible circuit board for the balloon catheter as described in claim 1, characterized in that, At least a portion of the colloid-containing space is formed by pores provided on the insulating substrate.

3. The flexible circuit board for the balloon catheter as described in claim 2, characterized in that, At least a portion of the holes are blind holes, and the depth of the blind holes is 0.2 to 0.8 times the thickness of the insulating substrate.

4. The flexible circuit board for balloon catheters as described in claim 2, characterized in that, The minimum spacing between any two holes is 0.5 to 5 times the side length or diameter of the hole.

5. The flexible circuit board for balloon catheters as described in claim 2, characterized in that, At least some of the holes are circular, square, rhomboid, regular pentagonal, or regular hexagonal in shape.

6. The flexible circuit board for the balloon catheter as described in claim 2, characterized in that, The diameter of the opening is 0.02 mm to 0.2 mm.

7. The flexible circuit board for balloon catheters as described in claim 1 or 2, characterized in that, At least a portion of the colloid-containing space is located on the side of the electrode sheet closest to the adhesive side.

8. The flexible circuit board for balloon catheters as described in claim 1 or 2, characterized in that, At least a portion of the edge of the insulating substrate is a complete region that does not contain the colloid-containing space, and the colloid-containing space is distributed in all other regions of the insulating substrate except for the complete region.

9. A balloon electrode assembly, characterized in that, include: A balloon, which is collapsible and inflatable; And a flexible circuit board, which is fixedly attached to the outer surface of the balloon and bonded to the balloon; the flexible circuit board is the balloon catheter flexible circuit board according to any one of claims 1 to 8.

10. A balloon ablation catheter, characterized in that, include: handle; An insertion tube is connected to the distal end of the handle; The balloon electrode assembly is fixed to the distal end of the insertion tube. The balloon electrode assembly includes a balloon and a flexible circuit board. The balloon is collapsible and inflatable. The flexible circuit board is fixedly attached to the outer surface of the balloon and is bonded to the balloon. The flexible circuit board is the flexible circuit board of the balloon catheter according to any one of claims 1 to 8.

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