Flexible circuit of balloon catheter and balloon catheter

Abstract

The utility model relates to a balloon catheter, in particular to a flexible circuit of the balloon catheter. A flexible circuit of a balloon catheter, comprising: an insulating base for affixing to a surface of a balloon; the electrode is attached and fixed to the surface of the insulating base body and used for making contact with the target tissue; at least one part of the edge of the insulation base body in the width direction is provided with an open hole, and the hole wall of the open hole is used for adhesion and fixation of an adhesive so as to improve the bonding strength between the insulation base body and the balloon. A manufacturing step of the flexible circuit: forming an open hole in at least one part of the edge of the width direction of the insulating substrate of the flexible circuit; and the flexible circuit is bonded and fixed to the surface of the balloon, so that at least one part of the hole wall of at least part of the open hole is attached and fixed to the adhesive, and the bonding strength between the insulating base body and the balloon is improved. The utility model mainly solves the problem that the bonding firmness between the flexible circuit of the balloon catheter and the balloon is not easy to guarantee.

Description

Technical Field

[0001] The utility model relates to a balloon catheter, in particular to a flexible circuit of the balloon catheter and the balloon catheter. Background Art

[0002] The balloon catheter is a medical device that can be used clinically to treat arrhythmias. It includes an inflatable and collapsible balloon (which can be inflated and collapsed by filling and releasing air or liquid) and a flexible circuit attached to the outer surface of the balloon. The flexible circuit includes an insulating substrate and electrodes. The electrodes can maintain good contact with the surface of the heart tissue, and then discharge based on a high-voltage pulse waveform to achieve ablation of the target tissue. When the balloon structure reaches the filled state, it has a large external surface area, based on which it can carry a larger area of ​​electrode distribution. During the operation, in order to achieve a better treatment effect, the balloon electrode needs to maintain good contact with the surface of the heart tissue.

[0003] Currently, balloon catheters have the following technical and process defects: the flexible circuit of the balloon catheter is usually attached to the outer surface of the balloon and then coated with adhesive to achieve gluing and fixing with the balloon. Since the surface of the flexible circuit is smooth, and the conductive layer of the flexible circuit has high inherent strength and high stress when bent, the degree of adhesion between the flexible circuit and the outer surface of the balloon and its effectiveness during its life cannot be well guaranteed. During the operation of balloon inflation and deflation, there is a potential risk of peeling or detaching of the flexible circuit from the outer surface of the balloon, which in turn raises concerns about the clinical use of balloon catheter products affecting their safety and effectiveness. Utility Model Content

[0004] The utility model mainly solves the technical problem that it is difficult to ensure the firmness of the bonding between the flexible circuit of the balloon catheter and the balloon.

[0005] In a first aspect, the utility model provides a flexible circuit of a balloon catheter.

[0006] Flexible circuits for balloon catheters, including:

[0007] An insulating substrate, the insulating substrate being used to be attached and fixed to the surface of the balloon so as to change its bending state as the balloon expands and collapses;

[0008] and an electrode, wherein the electrode is attached and fixed to the surface of the insulating substrate and is used for contacting the target tissue;

[0009] At least a portion of the edge of the insulating substrate in the width direction is provided with an opening, and the hole wall of the opening is used for adhesive to adhere and fix to improve the bonding strength between the insulating substrate and the balloon.

[0010] In a technical solution, the diameter of the opening ranges from 0.03 mm to 0.20 mm.

[0011] In a technical solution, the openings are provided in at least two rows, and the openings in each row are arranged along a direction from an edge in the width direction of the insulating substrate to a center in the width direction.

[0012] In a technical solution, at least part of the openings in at least one column of the openings are staggered with the openings in an adjacent column along the length direction of the flexible circuit.

[0013] In a technical solution, the distal end of the insulating substrate has an end portion for bending when the balloon collapses, and the openings are distributed on the widthwise edge and the central area of ​​the end portion.

[0014] In a technical solution, the openings are distributed at all locations along the edge of the insulating substrate in the width direction.

[0015] In a technical solution, the distance between the edge of the electrode and the edge of the insulating substrate is not less than 0.4 mm.

[0016] In a technical solution, the distance between the edge of the electrode and the edge of the insulating substrate is 0.4 mm to 2.0 mm.

[0017] In a technical solution, the electrode comprises at least two sheet-shaped electrodes spaced apart from the middle of the insulating substrate in the length direction to the distal end, and the edges of the sheet-shaped electrodes are smooth edges.

[0018] In a technical solution, the electrode comprises at least two sheet electrodes spaced apart from the middle of the length direction of an insulating substrate to the distal end, the insulating substrate comprises an intermediate connecting portion, and the intermediate connecting portion is arranged between two adjacent sheet electrodes along the length direction of the insulating substrate; the width of the intermediate connecting portion is smaller than the width of the sheet electrodes, and the opening is provided on at least the edges on both sides in the width direction of the intermediate connecting portion.

[0019] In a second aspect, the utility model provides a balloon catheter.

[0020] Balloon catheters, including:

[0021] a catheter tube having a proximal end and a distal end;

[0022] A balloon, the balloon being fixed to the distal end of the catheter body and being expandable and deflated;

[0023] and a flexible circuit, wherein the flexible circuit is bonded and fixed to the surface of the balloon; the flexible circuit of the balloon catheter comprises:

[0024] An insulating substrate, the insulating substrate being used to be attached and fixed to the surface of the balloon so as to change its bending state as the balloon expands and collapses;

[0025] and an electrode, wherein the electrode is attached and fixed to the surface of the insulating substrate and is used for contacting the target tissue;

[0026] At least a portion of the edge of the insulating substrate in the width direction is provided with an opening, and the hole wall of the opening is used for adhesive to adhere and fix to improve the bonding strength between the insulating substrate and the balloon.

[0027] In a technical solution, the diameter of the opening ranges from 0.03 mm to 0.20 mm.

[0028] In a technical solution, the openings are provided in at least two rows, and the openings in each row are arranged along a direction from an edge in the width direction of the insulating substrate to a center in the width direction.

[0029] In a technical solution, at least part of the openings in at least one column of the openings and the openings in an adjacent column are configured to be staggered along the length direction of the flexible circuit.

[0030] In a technical solution, the distal end of the insulating substrate has an end portion for bending when the balloon collapses, and the openings are distributed on the widthwise edge and the central area of ​​the end portion.

[0031] In a technical solution, the openings are distributed at all locations along the edge of the insulating substrate in the width direction.

[0032] In a technical solution, the distance between the edge of the electrode and the edge of the insulating substrate is not less than 0.4 mm.

[0033] In a technical solution, the distance between the edge of the electrode and the edge of the insulating substrate is 0.4 mm to 2.0 mm.

[0034] In a technical solution, the electrode comprises at least two sheet-shaped electrodes spaced apart from the middle of the insulating substrate in the length direction to the distal end, and the edges of the sheet-shaped electrodes are smooth edges.

[0035] In a technical solution, the electrode comprises at least two sheet electrodes spaced apart from the middle of the length direction of an insulating substrate to the distal end, the insulating substrate comprises an intermediate connecting portion, and the intermediate connecting portion is arranged between two adjacent sheet electrodes along the length direction of the insulating substrate; the width of the intermediate connecting portion is smaller than the width of the sheet electrodes, and the opening is provided on at least the edges on both sides in the width direction of the intermediate connecting portion.

[0036] Beneficial effects of the utility model:

[0037] According to the flexible circuit of the above-mentioned balloon catheter, at least a portion of the edge of the insulating substrate in the width direction is provided with an opening, and the hole wall of the opening is used for the adhesive to attach and fix. Since the hole wall of the opening is in a cross state with the surface of the balloon, the force direction of the adhesive at the opening can be changed, and the opening can increase the bonding width area. At the same time, the flexibility of the opening part on the flexible circuit is improved, and a flexible to rigid transition area can be formed from the edge of the flexible circuit in the width direction to the electrode direction. The transition area can reduce the stress between the insulating substrate and the balloon when the balloon expands and collapses, thereby improving the bonding strength between the flexible circuit and the outer surface of the balloon, avoiding tearing at the bonding point between the two, and achieving the purpose of improving the bonding firmness and reliability, which is beneficial to avoiding the potential risk of peeling or detachment between the flexible circuit and the outer surface of the balloon. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Figure 1 It is a structural schematic diagram of an embodiment of a balloon catheter in the utility model;

[0039] Figure 2 A schematic diagram of the structure of a flexible circuit of a balloon catheter;

[0040] Figure 3 for Figure 2 A schematic diagram of the structure of the farthest end of the flexible circuit and an electrode close to the far end;

[0041] Figure 4 for Figure 2 Schematic diagram of the structure at another electrode of the flexible circuit.

[0042] List of feature names corresponding to the reference numerals in the figure:

[0043] 10. Balloon; 20. Insulating substrate; 30. Electrode; 40. Opening; 51. First connecting seat; 52. First connecting seat. DETAILED DESCRIPTION

[0044] The present invention is further described in detail below by specific embodiments in conjunction with the accompanying drawings. Wherein similar elements in different embodiments adopt associated similar element numbers. In the following embodiments, many detailed descriptions are intended to enable the present application to be better understood. However, those skilled in the art can easily recognize that some of the features can be omitted in different situations, or can be replaced by other elements, materials, and methods. In some cases, some operations related to the present application are not shown or described in the specification, in order to avoid the core part of the present application being overwhelmed by too much description, and for those skilled in the art, it is not necessary to describe these related operations in detail, and they can fully understand the related operations based on the description in the specification and the general technical knowledge in the art.

[0045] In addition, the features, operations or characteristics described in the specification can be combined in any appropriate manner to form various implementations. At the same time, the steps or actions in the method description can also be interchanged or adjusted in a manner that is obvious to those skilled in the art. Therefore, the various sequences in the specification and the drawings are only for the purpose of clearly describing a certain embodiment and are not meant to be a required sequence, unless otherwise specified that a certain sequence must be followed.

[0046] The serial numbers of the components in this document, such as "first", "second", etc., are only used to distinguish the objects described and do not have any order or technical meaning. The "connection" and "coupling" mentioned in this application, unless otherwise specified, include direct and indirect connections (couplings).

[0047] In an embodiment of the utility model, the flexible circuit of the balloon catheter includes an insulating substrate 20 and an electrode 30. The insulating substrate 20 is used to be attached and fixed to the surface of the balloon 10 so as to change the bending state as the balloon 10 expands and collapses. The electrode 30 is attached and fixed to the surface of the insulating substrate 20 for contacting the target tissue. In order to improve the bonding strength between the insulating substrate 20 and the balloon 10, at least a portion of the width edge of the insulating substrate 20 is provided with an opening 40, and the hole wall of the opening 40 is used for the adhesive to adhere and fix. Since the hole wall of the opening 40 is in a cross state with the surface of the balloon 10, the force direction of the adhesive at the opening 40 can be changed, and the opening 40 can increase the bonding width area. At the same time, the flexibility of the opening 40 on the flexible circuit is improved, and a flexible to rigid transition area can be formed from the width edge of the flexible circuit toward the electrode 30. The transition area can reduce the stress between the insulating substrate 20 and the balloon 10 when the balloon 10 expands and collapses, thereby improving the bonding strength between the flexible circuit and the outer surface of the balloon 10, avoiding tearing at the bonding point between the two, and achieving the purpose of improving the bonding firmness and reliability.

[0048] It should be noted that the target tissue contacted by the electrode 30 attached and fixed to the surface of the insulating substrate 20 during use can be the area to be ablated in the organism or the area to be physiologically mapped in the organism; for the area to be ablated in the organism, the electrode 30 can ablate the target tissue by discharge, and for the area to be physiologically mapped in the organism, the electrode 30 can conduct bioelectric signals. In addition, the "proximal" and "distal" that appear below are conventional terms in the medical field. For the instrument to be operated, the proximal end is the end close to the operator of the instrument, and the distal end is the end far away from the operator of the instrument; Figure 1In the figure, the proximal end and the distal end are indicated by arrows. Furthermore, the flexible circuit has a length direction and a width direction perpendicular to the length direction and corresponding to the circumference of the balloon 10. In one embodiment, the length direction corresponds to the generatrix of the balloon 10 (a moving line revolves around a fixed straight line to form a rotation surface, the fixed straight line is called the axis of the rotating body, and the moving straight line is called the generatrix of the rotating body).

[0049] In one embodiment, the insulating substrate 20 of the flexible circuit can be formed of a PI film, which is a polyimide film (Polyimide Film), which is a commonly used film-type insulating material in the art. A trace can be set in the insulating substrate 20, and the trace is used to provide a conductive path for the electrode 30 attached and fixed on the surface of the insulating substrate 20 to achieve wiring of the electrode 30.

[0050] Please refer to Figure 1 The balloon electrode assembly of the balloon catheter shown in the figure has a plurality of flexible circuits disposed on the outer surface of the balloon 10, each flexible circuit being evenly distributed along the circumference of the balloon 10, the distal end of each flexible circuit being fixed to a first connecting seat 51 at the distal end of the balloon 10, and the proximal end of each flexible circuit being fixed to a second connecting seat 52 at the proximal end of the balloon 10. The specific fixing method can adopt the existing methods in the art. The number of flexible circuits on the balloon 10 can be determined according to the use requirements of the balloon catheter, and is not limited in the present utility model. In one embodiment, please refer to Figure 1 and Figure 2 , two sheet-shaped electrodes 30 are provided on the half section near the distal end of each flexible circuit, and the size of the one near the distal end of the two electrodes 30 is smaller than the one near the proximal end. It should be noted that in some other embodiments, the number of electrodes 30 on each flexible circuit can be increased or decreased according to the use requirements, for example, only one electrode can be provided, or more than three electrodes can be provided; in addition, electrodes can also be provided on the half section near the proximal end of the flexible circuit.

[0051] In one embodiment, the electrode includes at least two sheet electrodes spaced from the middle of the length direction of the insulating substrate 20 to the distal end, and the edge of the sheet electrode is a smooth edge, that is, the edge of the sheet electrode is composed of a straight edge and / or a curved edge connected to the straight edge and convex to the outside of the extension direction of the sheet electrode. Therefore, the edge of the sheet electrode adopts a smooth edge, the shape is relatively regular, it is easy to manufacture, a larger electrode area can be achieved, and the openings provided can ensure the flexibility of the flexible circuit. The specific shape of the electrode is not limited, for example, it can be an oblong, an oblong whose width gradually narrows from the proximal end to the distal end, an ellipse, a circle, etc., and can also be other shapes.

[0052] In one embodiment, the electrode 30 and the insulating substrate 20 are arranged in the center along the width direction of the flexible circuit, and the side edge of the electrode 30 in the width direction is spaced from the side edge of the insulating substrate 20 in the width direction, and the spacing forms an uncovered area not covered by the electrode 30 at the edge of the insulating substrate 20, and the area covered with the electrode 30 on the insulating substrate 20 is the electrode covered area. In some other embodiments, the width of the uncovered area on both sides of the insulating substrate 20 in the width direction may be different. Since the electrode 30 is made of metal material and has a certain thickness to ensure strength and flow capacity, plus the inherent strength of the insulating substrate 20, the flexible circuit has a certain bending resistance. When the bending state changes, stress will be generated at the bonding portion with the balloon 10, and the surface of the flexible circuit is relatively smooth, so the adhesive is easy to peel off or detach. In order to improve this situation, at least a portion of the edge of the insulating substrate 20 in the width direction is provided with an opening 40. In a specific embodiment, openings 40 are distributed at all places along the width direction edge of the insulating substrate 20, so that the uncovered area at the edge of the insulating substrate 20 forms a transition area. The flexibility of the transition area is higher than the electrode covering area of ​​the insulating substrate 20, so it can better produce bending deformation, thereby reducing the stress between the flexible circuit and the balloon 10 when the balloon 10 is filled and collapsed. At the same time, since the insulating substrate 20 is bonded and fixed to the outer surface of the balloon 10, and the hole wall of the opening 40 is used for the adhesive to adhere and fix, the force direction of the adhesive at the opening 40 can be changed, and it is beneficial to increase the bonding area between the insulating substrate and the balloon, thereby improving the bonding strength between the insulating substrate 20 and the balloon 10. In this way, the flexible circuit can be better bonded to the balloon 10 as a whole, which is beneficial to avoid the potential risk of peeling or detachment of the flexible circuit.

[0053] In one embodiment, the distance between the edge of the electrode 30 and the edge of the insulating substrate 20 is not less than 0.4 mm. Due to the provision of the opening 40, the insulating substrate 20 is more flexible and can be deformed more easily with the balloon 10. Therefore, the distance between the edge of the electrode 30 and the edge of the insulating substrate 20 can be set to be larger, thereby achieving a better bonding effect. In the industry, balloon catheters are generally inserted into the blood vessels through a sheath tube as an intervention channel, and the sheath tube diameter is limited. A sheath tube diameter that is too large will increase the patient's pain and limit the application scenarios. A sheath tube diameter that is too small will make it difficult for a balloon catheter to pass smoothly. Therefore, the generally recommended inner diameter of the sheath tube in the industry is 12Fr-13Fr (Fr is a unit used to describe the diameter in the field of catheter medical devices, 3Fr = 1mm). As for the balloon catheter, its diameter will be limited by the diameter of the sheath. In order to ensure the size of the electrode 30 within a limited overall size, the width of the uncovered area at the edge of the insulating substrate 20 cannot be too large. In a specific embodiment, the width of the uncovered area on one side is 0.4 mm to 2.0 mm, that is, the distance between the edge of the electrode 30 and the edge of the insulating substrate 20 is 0.4 mm to 2.0 mm. The specific value of the width can be determined based on the diameter of the balloon catheter, the number of flexible circuits attached to the balloon 10, the type of adhesive, the bonding strength requirements, etc.

[0054] In one embodiment, the diameter of the opening 40 ranges from 0.03 mm to 0.20 mm, which can avoid excessive impact on the structural strength of the flexible circuit. For example, in some other embodiments, the diameter of the opening 40 can be 0.08 mm. Under the condition of satisfying the flexibility of the structural strength of the insulating substrate 20, the diameter of the opening 40 can also be any other value between 0.03 mm and 0.20 mm. It should be noted that in some other embodiments, the diameter of the opening 40 can also be larger or smaller. For ease of processing, in a specific embodiment, the opening 40 is formed by a laser punching process. Of course, in other embodiments, the opening 40 can also be formed by other methods, such as stamping, puncture, etc.

[0055] In order to better avoid the occurrence of large stress on the flexible circuit during the process of balloon 10 collapse and filling, the openings 40 are arranged in at least two rows along the direction from the width edge of the insulating substrate 20 to the width center of the insulating substrate 20. Furthermore, at least one part of the openings in the at least two rows of openings 40 are arranged to be staggered along the length direction of the flexible circuit. Figure 2, two rows of openings 40 are respectively provided on both sides of the width direction of the electrode 30 on the insulating substrate 20, and the two rows of openings 40 are arranged in a staggered manner. Providing at least two rows of openings 40 can further improve the flexibility of the edge of the flexible circuit and better avoid the generation of stress. The staggered arrangement of at least two rows of openings 40 can further enhance this effect. Of course, in some other embodiments, the openings 40 can also be arranged in one row, or in three or more rows. In some cases, limited by the width of the flexible circuit, two rows are a relatively suitable arrangement.

[0056] In order to ensure that the edges of the flexible circuit and the balloon 10 can form a high bonding strength, such as Figure 2 , openings 40 are distributed at all positions along the width direction edge of the insulating substrate 20. In a specific embodiment, the distance between the edge of the electrode 30 and the edge of the insulating substrate 20 is 0.4 mm to 1.0 mm, which can form a wider rigid to flexible transition area and prevent the flexible circuit from being too wide, thereby preventing the balloon catheter from being too large after collapse.

[0057] In one embodiment, please refer to Figure 2 and Figure 3 The distal end of the insulating substrate 20 has a tip portion for bending when the balloon 10 collapses. After the balloon catheter collapses, when entering the sheath, the tip portion of the distal end will bend at a large angle. Therefore, the risk of the flexible circuit at the distal tip portion being peeled off is the greatest. To avoid this problem, the openings 40 of the tip portion are distributed more densely than the rest of the portion. In one embodiment, the openings 40 are distributed in the widthwise edge and the center area of ​​the tip portion. Figure 3 In addition to the two rows of openings 40 on the side edges in the width direction of the insulating substrate 20, three rows of openings 40 roughly arranged along the length direction of the flexible circuit can be arranged in the central area. Of course, arranging three rows of openings 40 to increase the distribution density of the openings 40 is an example. In other embodiments, the opening density can also be increased by other methods, such as evenly distributing several rows of inclined holes at the end portion, arranging some openings in an array, or arranging some openings in a concentric circle shape.

[0058] Please refer to Figure 3 : In some embodiments, the center line spacing a of two adjacent openings 40 in the same row is 0.08±0.01 mm; in some embodiments, the spacing b between the edge of the insulating substrate 20 and the center line of a row of openings 40 closest to the edge of the insulating substrate 20 is 0.05±0.01 mm; in some embodiments, the spacing c between the edge of the electrode 30 and the center line of a row of openings 40 closest to the edge of the electrode 30 is 0.05±0.01 mm. Figure 3In the figure, the center line spacing a of two adjacent openings 40 in the same row is 0.08 mm, the spacing b between the edge of the insulating substrate 20 and the center line of a row of openings 40 closest to the edge of the insulating substrate 20 is 0.05 mm, and the spacing c between the edge of the electrode 30 and the center line of a row of openings 40 closest to the edge of the electrode 30 is 0.05 mm. Figure 4 In the embodiment, the parameters of the opening 40 around the electrode 30 are Figure 3 same. Figure 3 and Figure 4 The a, b, and c marks are used to indicate the positions of corresponding parameters and are not intended to represent actual sizes and proportions.

[0059] In one embodiment, the insulating substrate 20 includes an intermediate connecting portion 21, which is disposed between two adjacent sheet electrodes along the length direction of the insulating substrate 20; the width of the intermediate connecting portion 21 is smaller than the width of the sheet electrodes, and the intermediate connecting portion 21 is provided with openings 40 at least on the edges of both sides in the width direction. The intermediate connecting portion 21 is relatively small in width and is provided with openings, which can reduce the stress on the intermediate connecting portion 21 when the balloon 10 is expanded and collapsed, and is conducive to making the flexible circuit collapse more easily with the balloon 10.

[0060] The method for making the balloon catheter comprises the following steps:

[0061] Step 1, providing an opening at least in a portion of the edge of the insulating substrate 20 of the flexible circuit in the width direction;

[0062] Step two, bonding and fixing the flexible circuit to the surface of the balloon 10 , so that at least a portion of the hole wall of at least part of the opening 40 is attached and fixed with the adhesive to improve the bonding strength between the insulating substrate 20 and the balloon 10 .

[0063] In a specific embodiment, the opening 40 is formed by laser punching. Of course, in other embodiments, the opening 40 can also be formed by other methods, such as stamping, puncture, etc. The adhesive between the flexible circuit and the balloon can be polyurethane glue, epoxy resin, acrylic resin, etc.

[0064] In one embodiment, the distal end of the insulating substrate 20 has an end portion for bending when the balloon 10 collapses, and the widthwise edge and the center area of ​​the end portion are distributed with openings 40. In one embodiment, the widthwise edge of the insulating substrate 20 is distributed with openings 40. In one embodiment, at least a portion of the hole wall of all the openings 40 is attached and fixed with an adhesive, and the size of the portion of the hole wall of the opening 40 attached with the adhesive can be determined according to the bonding strength requirements, so that the hole wall of the entire opening 40 is attached with the adhesive. In one embodiment, at least two rows of openings 40 are arranged along the widthwise edge of the insulating substrate 20 toward the widthwise center of the insulating substrate 20; further, at least a portion of the openings 40 in at least one row of openings are staggered with the openings 40 in the adjacent row along the length direction of the flexible circuit.

[0065] In one embodiment, when the flexible circuit is bonded and fixed to the surface of the balloon 10, the flexible circuit is first placed against the surface of the balloon 10, and then adhesive is applied to the width edge of the flexible circuit, so that at least part of the opening 40 is coated with adhesive and the adhesive contacts the balloon 10 through the opening 40. In some other embodiments, the method for making a balloon catheter may also apply adhesive to the side of the insulating substrate 20 close to the balloon 10, and then bond the insulating substrate 20 to the balloon 10, or apply adhesive to the balloon 10, and then bond the insulating substrate 20 to the balloon 10, or apply adhesive to both the insulating substrate 20 and the balloon 10, and then bond the two together.

[0066] A specific balloon catheter corresponding to the balloon catheter manufacturing method is as follows Figures 1 to 4 As shown, the relevant parameters are the same as any embodiment of the flexible circuit of the balloon catheter described above.

[0067] Embodiment of the balloon catheter in the utility model:

[0068] The balloon catheter comprises: a catheter body, the catheter body having a proximal end and a distal end; a balloon 10, the balloon 10 being fixed to the distal end of the catheter body, and the balloon 10 being expandable and deflated; and a flexible circuit, the flexible circuit being bonded and fixed to the surface of the balloon 10, the structure of the flexible circuit being the same as any embodiment of the flexible circuit of the above-mentioned balloon catheter, and will not be described again here. The structures of the above-mentioned balloon catheter except the flexible circuit can adopt existing solutions, and have no direct relationship with the improvement claimed by the present utility model, and will not be described in detail here.

[0069] The above specific examples are used to illustrate the present invention, which are only used to help understand the present invention and are not intended to limit the present invention. For those skilled in the art of the present invention, some simple deductions, deformations or substitutions can be made based on the idea of ​​the present invention.

Claims

1. A flexible circuit for a balloon catheter, characterized in that include: An insulating substrate, the insulating substrate being used to be attached and fixed to the surface of the balloon so as to change its bending state as the balloon expands and collapses; and an electrode, wherein the electrode is attached and fixed to the surface of the insulating substrate and is used for contacting the target tissue; At least a portion of the edge of the insulating substrate in the width direction is provided with an opening, and the hole wall of the opening is used for adhesive to adhere and fix to improve the bonding strength between the insulating substrate and the balloon.

2. The flexible circuit of the balloon catheter according to claim 1, characterized in that: The diameter of the opening ranges from 0.03 mm to 0.20 mm.

3. The flexible circuit of the balloon catheter according to claim 1 or 2, characterized in that: The openings are arranged in at least two rows, and the openings in each row are arranged along a direction from an edge in the width direction of the insulating substrate to a center in the width direction.

4. The flexible circuit of the balloon catheter according to claim 3, characterized in that: At least part of the openings in at least one column of the openings are staggered with the openings in an adjacent column along the length direction of the flexible circuit.

5. The flexible circuit of the balloon catheter according to claim 1 or 2, characterized in that: The distal end of the insulating substrate has an end portion for bending when the balloon collapses, and the openings are distributed on the widthwise edge and the central area of ​​the end portion.

6. The flexible circuit of the balloon catheter according to claim 1 or 2, characterized in that: The distance between the edge of the electrode and the edge of the insulating substrate is not less than 0.4 mm.

7. The flexible circuit of the balloon catheter according to claim 6, characterized in that: The distance between the edge of the electrode and the edge of the insulating substrate is 0.4 mm to 2.0 mm.

8. The flexible circuit of the balloon catheter according to claim 1 or 2, characterized in that: The electrode comprises at least two sheet-shaped electrodes which are arranged at intervals from the middle part to the distal end in the length direction of the insulating substrate, and the edges of the sheet-shaped electrodes are smooth edges.

9. The flexible circuit of the balloon catheter according to claim 1 or 2, characterized in that: The electrode comprises at least two sheet electrodes spaced apart from the middle of the insulating substrate in the length direction to the distal end, the insulating substrate comprises an intermediate connecting portion, and the intermediate connecting portion is arranged between two adjacent sheet electrodes along the length direction of the insulating substrate; the width of the intermediate connecting portion is smaller than the width of the sheet electrodes, and the opening is provided on at least the edges on both sides in the width direction of the intermediate connecting portion.

10. A balloon catheter, characterized in that: include: a catheter tube having a proximal end and a distal end; A balloon, the balloon being fixed to the distal end of the catheter body and being expandable and deflated; and a flexible circuit, wherein the flexible circuit is adhesively fixed to the surface of the balloon, and the flexible circuit is the flexible circuit described in any one of claims 1 to 9.

Images