Shock wave generating assembly, electrode balloon catheter and manufacturing method

Abstract

The present application is about a shock wave generating component, an electrode balloon catheter and a manufacturing method. The shock wave generating component includes: a substrate, the substrate is a flexible member; a metal wire layer, located on one side of the substrate; an insulating layer, at least covering the metal wire layer; an electrode pair, along the arrangement direction of the substrate and the insulating layer, the electrode pair is located on at least one side of the insulating layer, the electrode pair is electrically connected to the metal wire layer, the electrode pair includes a first electrode and at least one second electrode, the first electrode and the second electrode are arranged at intervals through the insulating layer, and in the projection of the electrode pair in the direction of the substrate, at least part of the first electrode and at least part of the second electrode are exposed from the insulating layer. The solution provided by the present application can solve the problem that the electrode balloon catheter is difficult to pass through the blood vessel or even breaks.

Description

Technical Field

[0001] The present application relates to the field of medical device technology, and in particular to a shock wave generating assembly, an electrode balloon catheter and a manufacturing method thereof. Background Art

[0002] In surgeries to treat narrow or calcified blood vessels, electrode balloon catheters are usually used. During use, the catheter needs to be inserted into the blood vessel and the balloon is aligned with the location of the calcified lesion, using the generated shock wave and liquid propagation to impact the corresponding location, thereby achieving the purpose of treatment. For electrode balloon catheters, since the balloon position needs to be equipped with a component that generates shock waves, the diameter of the corresponding balloon position is larger than the diameter of other parts of the catheter, making it difficult for the electrode balloon catheter to pass through the blood vessel and even causing it to break. Summary of the invention

[0003] In order to solve or partially solve the problems existing in the related art, the present application provides a shock wave generating component, an electrode balloon catheter and a manufacturing method, which can solve the problem that the electrode balloon catheter is difficult to pass through the blood vessel or even breaks.

[0004] The first aspect of the present application provides a shock wave generating assembly, comprising:

[0005] A substrate, wherein the substrate is a flexible member;

[0006] A metal wire layer, located on one side of the substrate;

[0007] an insulating layer, at least covering the metal wire layer;

[0008] an electrode pair, along the arrangement direction of the substrate and the insulating layer, the electrode pair is located on at least one side of the insulating layer, the electrode pair is electrically connected to the metal wire layer,

[0009] The electrode pair includes a first electrode and at least one second electrode, the first electrode and the second electrode are arranged with spacing through the insulating layer, and in a projection of the electrode pair toward the substrate, at least part of the first electrode and at least part of the second electrode are exposed from the insulating layer.

[0010] A second aspect of the present application provides an electrode balloon catheter, comprising:

[0011] Internal catheter;

[0012] At least one shock wave generating assembly, wherein the shock wave generating assembly is the shock wave generating assembly described above, the shock wave generating assembly is enclosed in the circumference of the inner conduit, and a plurality of the shock wave generating assemblies are arranged along the axial direction of the inner conduit;

[0013] The balloon is sleeved on the outer wall of the inner catheter and at least covers the shock wave generating component.

[0014] The third aspect of the present application provides a method for manufacturing an electrode balloon catheter, the electrode balloon catheter comprising an inner catheter, at least one shock wave generating component and a balloon, the shock wave generating component being connected to the outer wall of the inner catheter, the balloon being sleeved on the outer wall of the inner catheter and at least covering the shock wave generating component, the manufacturing method comprising:

[0015] forming the shock wave generating assembly, wherein the shock wave generating assembly comprises a substrate, a metal wire layer, an insulating layer and an electrode pair, wherein the electrode pair comprises a first electrode and at least one second electrode, wherein the substrate is a flexible member, wherein a metal wire layer and the second electrode and the first electrode electrically connected to the metal wire layer are prepared on the substrate, wherein the first electrode and the second electrode are separated by the insulating layer, wherein the insulating layer at least covers the metal wire layer, and in a projection of the electrode pair toward the substrate, at least a portion of the first electrode and at least a portion of the second electrode are exposed from the insulating layer; and

[0016] The shock wave generating assembly is mounted on the inner conduit.

[0017] The technical solution provided by the present application may include the following beneficial effects: the shock wave generating assembly includes: a substrate, a metal wire layer, an insulating layer and an electrode pair, the substrate is a flexible member, the metal wire layer is located on one side of the substrate, the insulating layer at least covers the metal wire layer, the electrode pair is located on at least one side of the insulating layer along the arrangement direction of the substrate and the insulating layer, the electrode pair is electrically connected to the metal wire layer, the electrode pair includes a first electrode and at least one second electrode, the first electrode and the second electrode are arranged at intervals through the insulating layer, and in the projection of the electrode pair to the substrate direction, at least part of the first electrode and at least part of the second electrode are exposed from the insulating layer. By setting a flexible substrate and forming the electrode pair thereon, a shock wave generating assembly is formed to be electrically connected to an external high-voltage generating device. The formed shock wave generating assembly can be easily installed on a catheter due to its flexible bending and deformation ability, reducing the difficulty of assembly, and when the shock wave generating assembly is prepared into an annular structure that cooperates with the catheter, it can be conveniently and quickly realized by only using the flexible deformation ability of the substrate. At the same time, since the electrode is directly formed on the substrate, the substrate provides protection for the bending and deformation of the electrode, avoiding direct bending of the hard electrode to damage the electrode. Furthermore, when the electrode balloon catheter is inserted into the human body, since the shock wave generating assembly is connected to the inner catheter through a flexible member as a substrate, and the electrode is formed on the substrate, when entering a narrow blood vessel or a local squeeze, the substrate can provide a compression buffer for the electrode, preventing the electrode from directly contacting the squeezed part and scratching the balloon or even human tissue, thereby ensuring that the electrode balloon catheter with such a shock wave generating assembly has good passability. In addition, for the form of forming the electrode using a flexible substrate, this structural coordination using an insulating layer for insulation can reduce the overall thickness of the shock wave generating assembly, which is conducive to reducing the thickness of the electrode to improve its passability in the human body.

[0018] It should be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The above and other objects, features and advantages of the present application will become more apparent through a more detailed description of exemplary embodiments of the present application in conjunction with the accompanying drawings, wherein the same reference numerals generally represent the same components in the exemplary embodiments of the present application.

[0020] Figure 1 : is a schematic cross-sectional structure diagram of a shock wave generating assembly shown in an embodiment of the present application, wherein the direction indicated by arrow L is the arrangement direction of the substrate and the insulating layer;

[0021] Figure 2 is another cross-sectional structural schematic diagram of the shock wave generating assembly shown in the embodiment of the present application, wherein the direction indicated by the arrow L is the arrangement direction of the substrate and the insulating layer;

[0022] Figure 3 is a top view of a substrate in a shock wave generating assembly shown in an embodiment of the present application;

[0023] Figure 4 is a top view of a shock wave generating assembly shown in an embodiment of the present application;

[0024] Figure 5 is another cross-sectional structural schematic diagram of the shock wave generating assembly shown in the embodiment of the present application, wherein the direction indicated by the arrow L is the arrangement direction of the substrate and the insulating layer;

[0025] Figure 6 It is a simple structural cross-sectional view of the shock wave generating assembly shown in the embodiment of the present application when it is in the electrode balloon catheter;

[0026] Figure 7 It is a schematic diagram of a simple structural cross-section of an electrode balloon catheter shown in an embodiment of the present application. DETAILED DESCRIPTION

[0027] The embodiments of the present application will be described in more detail below with reference to the accompanying drawings. Although the embodiments of the present application are shown in the accompanying drawings, it should be understood that the present application can be implemented in various forms and should not be limited by the embodiments described herein. On the contrary, these embodiments are provided to make the present application more thorough and complete, and to fully convey the scope of the present application to those skilled in the art.

[0028] The terms used in this application are for the purpose of describing specific embodiments only and are not intended to limit this application. The singular forms of "a", "said" and "the" used in this application and the appended claims are also intended to include plural forms unless the context clearly indicates other meanings. It should also be understood that the term "and / or" used herein refers to and includes any or all possible combinations of one or more associated listed items.

[0029] It should be understood that although the terms "first", "second", "third", etc. may be used in this application to describe various information, this information should not be limited to these terms. These terms are only used to distinguish the same type of information from each other. For example, without departing from the scope of this application, the first information may also be referred to as the second information, and similarly, the second information may also be referred to as the first information. Thus, the features defined as "first" and "second" may explicitly or implicitly include one or more of the features. In the description of this application, the meaning of "multiple" is two or more, unless otherwise clearly and specifically defined.

[0030] In surgeries using electrophysiological therapy, using a catheter to transfer energy and perform tissue ablation is a common method. After the tip of the catheter enters the human body and reaches the corresponding treatment target, the tail end of the catheter sends energy such as pulses through the connected electrical device, so that the energy output component set at the tip outputs energy combined with liquid to act on the lesion location. Taking the electrode balloon catheter used to treat narrow or calcified blood vessels as an example, the tip of the catheter outputs the generated shock wave energy through the shock wave generating component set, and uses the filling liquid in the space formed by the balloon covering the shock wave generating component to spread the shock energy to impact the calcified location, thereby achieving the treatment purpose.

[0031] The shock wave generating assembly is provided with electrodes for generating shock wave energy. In the electrode balloon catheter, the shock wave generating assembly is provided on the outer wall of the inner catheter and is covered by a deformable balloon. When the electrode balloon catheter is used, the balloon is covered on the outer wall of the inner catheter and contacts the shock wave generating assembly. In this state, the catheter is inserted into the human body and the outer wall of the balloon is aligned with the lesion. After the positioning is completed, the electrical device at the tail end of the catheter is started, and the filling fluid enters between the balloon and the outer wall of the inner catheter, so that the balloon can contract and expand in the radial direction of the catheter under the action of the filling fluid. At the same time, the shock wave generating assembly located in the balloon can generate shock waves of different degrees under the control of the electrical device. The shock wave propagates in the liquid to hit the corresponding lesion position, thereby achieving the treatment purpose.

[0032] It is understandable that the filling liquid filled in the balloon can be a liquid that can be used in the human body, such as physiological saline, contrast agent, or a mixed solution of the two, etc., which is not specifically limited here. However, the filling liquid is preferably a liquid with good conductive properties to facilitate the occurrence of the hydroelectric effect.

[0033] Optionally, an electrical device (such as a high voltage generating device) connected to the tail end of the catheter is electrically connected to the shock wave generating assembly via wires to be able to control the intensity of the shock wave generated, and its specific implementation method is not described in detail here.

[0034] When using an electrode balloon catheter to treat narrow or calcified blood vessels, during the operation of inserting the catheter into the blood vessel, the balloon position is where the electrode that generates the shock wave is set, and the catheter diameter at this position is larger than that at other positions, resulting in poor passability and easy breakage during the process of catheter intervention in the human body. In addition, when passing through relatively narrow blood vessels or due to improper human operation, when the side wall of the balloon is partially squeezed and deformed, the electrode can easily scratch the balloon, causing damage to the electrode balloon catheter.

[0035] In view of the above problems, an embodiment of the present application provides a shock wave generating assembly, which can solve the problem that the electrode balloon catheter is difficult to pass through the blood vessel or even breaks.

[0036] The technical solution of the embodiments of the present application is described in detail below with reference to the accompanying drawings.

[0037] Figure 1 It is a schematic diagram of a cross-sectional structure of a shock wave generating assembly shown in an embodiment of the present application, wherein the direction indicated by the arrow L is the arrangement direction of the substrate and the insulating layer.

[0038] like Figure 1 As shown, as an embodiment of the present application, the shock wave generating assembly includes a substrate 1, which is a flexible member; a metal wire layer 3, which is located on one side of the substrate 1; an insulating layer 2, which at least covers the metal wire layer 3; an electrode pair 4, which is arranged along the direction L of the substrate 1 and the insulating layer 2 (as shown in FIG. Figure 1 The electrode pair 4 is located on at least one side of the insulating layer 2, and the electrode pair 4 is electrically connected to the metal wire layer 3. The electrode pair 4 includes a first electrode 41 and at least one second electrode 42. The first electrode 41 and the second electrode 42 are arranged at intervals through the insulating layer 2. In the projection of the electrode pair 4 toward the substrate 1, at least part of the first electrode 41 and at least part of the second electrode 42 are exposed from the insulating layer 2.

[0039] It should be emphasized here that the first electrode 41 and the second electrode 42 can be metals with good conductivity, such as gold, silver, copper, platinum, tungsten, etc., or non-metals with good conductivity, such as graphite, which are not specifically limited here.

[0040] Optionally, the substrate 1 may be a flexible member with bending and deformation capabilities made of polyvinyl alcohol, polyester, polyimide and other materials as main materials, and the substrate 1 does not have conductive capabilities, which is not specifically limited here.

[0041] Furthermore, in the shock wave generating assembly, based on the deformable substrate 1, the corresponding electrode pairs 4, metal wire layers 3, etc. are directly formed thereon, so that the thickness of each layer formed on the substrate 1 can be thinner, thereby reducing the overall thickness of the shock wave generating assembly.

[0042] By setting a flexible substrate 1 and forming an electrode pair 4 thereon, a shock wave generating assembly is formed to be electrically connected to an external high-voltage generating device. The formed shock wave generating assembly can be easily installed on a catheter due to its flexible bending and deformation ability, which reduces the difficulty of assembly. Moreover, when the shock wave generating assembly is prepared into a ring structure matched with the catheter, it can be conveniently and quickly realized by using the flexible deformation ability of the substrate 1. At the same time, since the electrode pair 4 is directly formed on the substrate 1, the substrate 1 provides protection for the bending and deformation of the electrode, avoiding direct bending of the rigid electrode to damage the electrode. Moreover, when the electrode balloon catheter is inserted into the human body, since the shock wave generating assembly is connected to the inner catheter through a flexible member as the substrate 1, and the electrode is formed on the substrate, when entering a narrow blood vessel or local extrusion, the substrate 1 can provide compression or dislocation buffering for the electrode, avoiding the electrode directly contacting the extruded part and scratching the balloon or even human tissue, thereby ensuring the good passability of the electrode balloon catheter provided with such a shock wave generating assembly. In addition, for the form of forming the electrode using the flexible substrate 1, this kind of structural coordination using the insulating layer 2 for insulation makes it light and flexible, which can reduce the overall thickness of the shock wave generating component, and is conducive to reducing the thickness of the electrode to improve its passability in the human body.

[0043] Optionally, for the first electrode 41 and / or the second electrode 42 prepared on the substrate 1, when any electrode is prepared on the substrate 1, it can be directly prepared on the surface or inside of the substrate 1 by magnetron sputtering, printing, 3D printing, electroplating or vapor deposition. This direct preparation method makes the electrode and the substrate 1 more integrated, avoids the electrode from falling off, and utilizes the flexible substrate 1 to play a better auxiliary role for the electrode, which is beneficial to the overall thinning of the shock wave generating assembly.

[0044] It is understandable that the metal wire layer 3 located on one side of the substrate 1 can be arranged on the surface of the substrate 1 to form an independent layer structure, or it can be arranged on the surface of the substrate 1 to form an independent layer structure. Figure 1 The dotted line in the figure is arranged in the base 1, and no specific limitation is made here. In the present application, in order to enable the electrode balloon catheter to have higher permeability, it is preferred to arrange the metal wire layer 3 in the base 1, and the structure of the metal wire layer 3 partially protrudes from the base 1 or does not protrude from the surface of the base 1 at all, thereby reducing the overall thickness of the shock wave generating assembly, which is beneficial to reduce the overall diameter when the shock wave generating assembly is installed in the catheter, thereby improving the permeability of the electrode balloon catheter when intervening in the human body.

[0045] The first electrode 41 and the second electrode 42 which are insulated by the insulating layer 2 and are disposed on the substrate 1 may include a variety of different structural combinations. The present application is described in detail with specific examples below, but is not limited thereto.

[0046] In one embodiment, if Figure 1 and Figure 2 As shown, along the arrangement direction L of the substrate 1 and the insulating layer 2, the first electrode 41 is located on the side of the insulating layer 2 away from the substrate 1, and the second electrode 42 is at least partially located on the side of the substrate 1 facing the insulating layer 2, and the insulating layer 2 is provided with a through hole 21 corresponding to the position of the second electrode 42, for exposing at least part of the second electrode 42. One of the first electrode 41 and the second electrode 42 is set as a positive electrode and the other is set as a negative electrode by a connected high-voltage generator. After the high-voltage generator emits a high-voltage pulse to the two electrodes, a field is formed between the positive electrode and the negative electrode to discharge, thereby forming the required shock wave. It can be understood that the setting of the positive and negative electrodes in the first electrode 41 and the second electrode 42 can be adjusted by the change of the pulse emitted by the high-voltage generator, as long as it can form a matching electrode pair of positive and negative electrodes, and whether the electrode is a positive electrode or a negative electrode is not specifically limited here.

[0047] Among them, for the first electrode 41 arranged on the insulating layer 2, in order to make it have better flexible deformation ability, the first electrode 41 is formed on the flexible insulating layer 2. Similarly, the first electrode 41 prepared on the insulating layer 2 can be directly prepared on its surface or inside by magnetron sputtering, printing, 3D printing, electroplating or vapor deposition. It can be understood that in order to reduce the overall thickness of the shock wave generating assembly, the thickness of the insulating layer 2 should not be too thick while ensuring that it can play an insulating effect, and no specific limitation is made here. As for the first electrode 41 formed thereon, the thickness of the first electrode 41 can be adjusted according to the different thicknesses set by the insulating layer 2 and whether it is formed on its surface or at least partially extends into the insulating layer. However, the maximum thickness of the first electrode 41 cannot exceed 0.04 mm, and no specific limitation is made here.

[0048] In order to reduce the overall thickness of the shock wave generating assembly, ensure that its diameter is smaller when installing the electrode balloon catheter to improve passability. At least part of the second electrode 42 can be arranged in the substrate 1, so that the sum of the thickness of the second electrode 42 and the substrate 1 can be smaller. Optionally, the substrate 1 is provided with a recess 11, and the second electrode 42 is at least partially connected to the recess 11. Along the arrangement direction L of the substrate 1 and the insulating layer 2, the through hole 21 is located in the shadow range formed by the recess 11. The recess 11 provided can be processed by etching or the like, and the second electrode 42 is directly formed in the recess 11 to improve the integration performance of the second electrode 42 and the substrate 1.

[0049] It can be understood that, for the recess 11 provided for arranging the second electrode 42, along the arrangement direction L of the substrate 1 and the insulating layer 2, the depth of the recess 11 is not greater than one third of the thickness of the substrate 1. Thus, it can be ensured that the second electrode 42 is installed on the substrate 1, and it can also be ensured that the substrate 1 drives the second electrode 42 to have a good deformation ability, which can facilitate the installation to form an electrode balloon catheter. When the second electrode 42 is squeezed in the thickness direction, the deformation ability of the substrate 1 can be used to provide it with contraction deformation, which is beneficial to the passability of the narrow blood vessel position and avoids the damage of the balloon by the hard electrode.

[0050] In one embodiment, if Figure 3 As shown, when the substrate is simultaneously provided with a metal wire layer 3 and a second electrode 42 is provided through a recess 11, in order to avoid providing too many structures on the substrate 1 to reduce the flexibility of the substrate 1, so as to ensure that the substrate 1 can have a better performance. The recess 11 can overlap with the channel where the metal wire layer 3 is provided, and the second electrode 42 can be provided above the connecting line corresponding to the metal wire layer 3. This method can simplify the structural design of the substrate 1, so that the substrate 1 can give full play to its flexibility.

[0051] Specifically, a wiring channel 31 is provided on one side of the substrate 1 close to the insulating layer 2 (the recess 11 is part of the wiring channel 31), and the metal wire layer 3 includes at least a first electrode line and a second electrode line, which are arranged in the wiring channel 31 for connecting with the first electrode 41 and the second electrode 42 respectively. The way in which the recess 11 overlaps with the wiring channel 31 avoids the need to provide a recess 11 on the substrate 1 to provide the second electrode 42, thereby reducing the wiring difficulty of the electrical connection between the second electrode 42 and the second electrode line. In addition, the wiring channel 31 for providing the first electrode line and the second electrode line can be in the form of straight grooves respectively provided on the substrate 1 and extending in the horizontal direction, which has a simple structure and avoids the influence of complex structural settings on the intensity and stability of shock waves formed by the electrodes.

[0052] Optionally, the wiring channel 31 may be: Figure 3The grooves that run through the horizontal direction shown in the figure may also be in a non-through form, which is not specifically limited here. Similarly, in order to avoid the electrode wires set on the substrate 1 affecting the flexibility of the substrate 1, the thickness of the electrode wires in the thickness direction of the substrate 1 does not exceed 0.04mm. As for the wiring channel 31 set, the width of the wiring channel 31 along the extension direction can be between 0.05-0.15, and the depth along the thickness direction of the substrate 1 can be between 0.03-0.1mm, so as to avoid the setting of an overly large channel affecting the flexibility of the substrate 1 itself as a shock wave generating component after being used as a connecting electrode, and to ensure better passability. The specific design of the wiring channel 31 can be selected according to the actual situation such as the material of the electrode wire selected by the staff to ensure the safety of power supply and the flexibility of the shock wave generating component, which is not specifically limited here.

[0053] Continue as Figure 1 and Figure 2 ,as well as Figure 4 As shown, for the second electrode 42, when it is set on the substrate 1, the insulating layer 2 above the second electrode 42 is provided with a through hole 21 to connect the second electrode 42 with the outside. When the first electrode 41 and the second electrode 42 are assigned positive and negative electrodes, a field strength can be formed between the two to generate a shock wave. For the second electrode 42, in order to ensure the good flexibility of the shock wave generating component, the second electrode 42 can be as follows Figure 1 The entirety of the substrate 1 does not extend outward. Alternatively, it may be as follows Figure 2 As shown in , the second electrode 42 includes a connecting portion 421 and a reaction portion 422 connected to each other, the connecting portion 421 is connected to the recess 11, and the reaction portion 422 extends out of the insulating layer 2 through the through hole 21, so that part of the reaction portion 422 is arranged in the same layer as the first electrode 41, and the first electrode 41 and the reaction portion 422 are gap-matched. In the form of the connecting portion 421 and the reaction portion 422, on the basis of arranging the second electrode 42 on the substrate 1, the reaction portion 422 extends out from the through hole 21 and is arranged in the same layer as the first electrode 41, so that the discharge gap between the first electrode 41 and the second electrode 42 can be significantly reduced without affecting the overall flexibility, so that the breakdown energy required for electrode discharge is reduced, and discharge is easier.

[0054] Among them, in the structural coordination of the first electrode 41 and the second electrode 42 arranged on the substrate 1, in order to enable it to have a better discharge effect, in the projection of the electrode toward the substrate 1, the first electrode 41 covers the second electrode 42, and a small gap for generating shock waves is reserved between the first electrode 41 and the second electrode 42. That is, the first electrode 41 can be a plate-like structure covering the insulating layer 2, and the first electrode 41 has a through hole 411. Along the arrangement direction L of the substrate 1 and the insulating layer 2, the through hole 411 at least covers the through hole 21. The first electrode 41 and the second electrode 42 are sleeved annular structures. The circumference of the second electrode 42 can react with the circumference of the first electrode 41.

[0055] Optionally, the end of the reaction portion 422 of the second electrode 42 is configured as a hemispherical structure having an arc surface 422a, so as to increase the effective area of ​​the second electrode 42 capable of reacting with the first electrode 41, reduce the loss rate of the first electrode 41 when the liquid-electric effect occurs, and improve the electrode life. Figure 5 As shown, the hemispherical structure of the arc surface 422a can also be replaced by a conical structure with an inclined surface 422b, so that the electrohydraulic effect is easier to carry out, the energy of the generated shock wave is greater, and the lithotripsy effect on vascular lesions is better, which is not specifically limited here.

[0056] It can be understood that, in the above-mentioned matching structure of sleeve-connecting the first electrode 41 and the second electrode 42, when the electrode pair 4 is provided in plurality, it is not necessary to separately provide the first electrode 41, and it is only necessary to provide the sleeve-connected second electrode 42 on the basis of the first electrode 41. That is, the second electrode 42 includes more than two, the insulating layer 2 covers the substrate 1, the first electrode 41 covers part of the insulating layer 2, and the plurality of second electrodes 42 are arranged at intervals in the first electrode 41 along the projection direction of the insulating layer 2 to the substrate 1. Different shock waves can be formed according to the different voltages given to the second electrodes 42, and the same voltage can also be given to the second electrodes 42 to generate the same shock wave, which acts evenly on the lesion position and expands the treatment area.

[0057] In order to be able to electrically connect the second electrode 42 and the first electrode 41 to the high voltage generating device through corresponding electrode wires, such as Figure 4 As shown, the shock wave generating assembly further includes at least one pad 5, which is electrically connected to the metal wire layer 3, and the pad 5 is exposed through the insulating layer 2 along the arrangement direction of the substrate 1 and the insulating layer 2. The pad 5 is provided to electrically connect the electrode wire therein with the high-voltage generating device through an electric wire, and the positive or negative wire electrically connected to the high-voltage generating device is respectively connected to the pad 5 by pressing or welding, thereby connecting the power supply to receive the high-voltage pulse.

[0058] The present application also provides an electrode balloon catheter, such as Figure 6and Figure 7 As shown, the electrode balloon catheter includes an inner catheter 200, at least one shock wave generating assembly 100, the shock wave generating assembly 100 is the shock wave generating assembly 100 described above, the shock wave generating assembly 100 is enclosed in the circumference of the inner catheter 200, and a plurality of shock wave generating assemblies 100 are arranged along the axial direction of the inner catheter 200, and a balloon 300 is sleeved on the outer wall of the inner catheter 200 and at least covers the shock wave generating assembly 100. And a high-voltage generating device 400, the positive and negative electrodes of the high-voltage generating device 400 are respectively connected to the pads through electric wires, so that they are connected to the corresponding first electrode wire and the second electrode wire through the pads. When the shock wave generating assembly 100 is enclosed in the circumference of the inner catheter 200, based on its flexible substrate 1, the shock wave generating assembly 100 can be easily and quickly supported into a cylindrical shape by, for example, mechanical rolling, and then installed on the outside of the inner catheter 200. The electrode balloon catheter formed by the light weight and strong flexibility of the shock wave generating assembly 100 makes it easy to process and improve the matching accuracy when the shock wave generating assembly 100 is prepared in the inner catheter 200. At the same time, the flexibility can make the electrode balloon catheter more passable in the human body.

[0059] Optionally, in order to meet the requirement of a stronger passability of the electrode balloon catheter in the human body, when the shock wave generating assembly 100 is prepared into a cylindrical structure and sleeved on the inner catheter 200, the thickness of the shock wave generating assembly 100 in the inner catheter 200 along the radial direction of the inner catheter 200 does not exceed 0.3 mm. When the shock wave generating assembly 100 is designed, the overall thickness of the shock wave generating assembly 100 will also be different according to the setting of the electrode and the different matching with the substrate 1, so as to meet the requirement of a smaller diameter as possible when the shock wave generating assembly 100 is matched with the inner catheter 200, so as to improve the passability of the electrode balloon catheter. Therefore, the side of the substrate 1 away from the insulating layer 2 can be attached to the surface of the inner catheter 200, or at least a part of the substrate 1 can also be embedded in the outer wall of the inner catheter 200, which is not specifically limited here.

[0060] It is understandable that when the shock wave generating assembly 100 is provided with a plurality of second electrodes 42, when it is prepared into a cylindrical structure to cooperate with the inner catheter 200, the plurality of second electrodes 42 are evenly arranged along the circumference of the inner catheter 200. For example, when there are two second electrodes 42, when the shock wave generating assembly 100 is prepared in the inner catheter 200, the angle between the two second electrodes 42 is 180°, so that the two are relatively arranged on the same straight line, so as to form a uniform shock wave acting on the lesion position, and the action area can be increased.

[0061] Based on the electrode balloon catheter described above, the present application also provides a method for manufacturing an electrode balloon catheter, the manufacturing method comprising:

[0062] A formed shock wave generating assembly 100, the shock wave generating assembly 100 comprises a substrate 1, a metal wire layer, an insulating layer 2 and an electrode pair, the electrode pair comprises a first electrode 41 and at least one second electrode 42, the substrate 1 is a flexible member, a metal wire layer and a second electrode 42 and a first electrode 41 electrically connected to the metal wire layer are prepared on the substrate 1, the first electrode 41 and the second electrode 42 are separated by an insulating layer 2, the insulating layer 2 at least covers the metal wire layer, and in a projection of the electrode pair toward the substrate 1, at least a portion of the first electrode 41 and at least a portion of the second electrode 42 are exposed from the insulating layer 2; and

[0063] The shock wave generating assembly 100 is installed on the inner conduit 200 .

[0064] In the above-mentioned manufacturing method, by first forming the shock wave generating assembly 100, the formed shock wave generating assembly 100 is in the form of using a flexible member as the substrate 1, directly preparing and forming the first electrode 41 and the second electrode 42 on the substrate 1, and using the thin film structure of the insulating layer 2 to reduce the thickness while insulating. The obtained shock wave generating assembly 100 can not only be thinner, but also has the characteristics of lightness and flexibility due to the provision of a flexible substrate 1 and an insulating layer 2. When the shock wave generating assembly 100 is installed in the inner catheter 200, the installation difficulty can be reduced, and the diameter of the obtained electrode balloon catheter can be smaller, which is conducive to the passability in the human body. Moreover, when the part of the electrode corresponding to the electrode of the electrode balloon catheter is locally squeezed by human tissue, the flexibility of the substrate 1 enables it to play a role in buffering deformation and avoid scratching the balloon by the electrode. Optionally, when forming the shock wave generating assembly 100, the specific matching form and implementation means between the substrate 1, the metal wire layer, the insulating layer 2 and the electrode pair can refer to the description of the shock wave generating assembly 100 mentioned above, and will not be described in detail here.

[0065] Among them, the manufacturing method of installing the shock wave generating assembly 100 on the inner catheter 200 includes: installing at least one shock wave generating assembly 100 on the inner catheter 200, and multiple shock wave generating assemblies 100 are arranged along the axial direction of the inner catheter 200. When the shock wave generating assembly 100 is installed on the inner catheter 200, the shock wave generating assembly 100 is prepared into a cylindrical structure that matches the outer wall of the inner catheter 200 and is sleeved on the outer wall of the inner catheter 200. The second electrode 42 in the shock wave generating assembly 100 includes more than two, and the multiple second electrodes 42 are evenly arranged along the circumference of the inner catheter. The substrate 1 is attached to the surface of the inner catheter 200, or at least part of the substrate 1 is embedded in the outer wall of the inner catheter 200. The shock wave generating assembly 100 is prepared into a cylindrical shape by mechanical rolling, and the processing technology is simple and efficient; with the characteristics of light weight and strong flexibility of the flexible material, the prepared shock generating device has better flexibility, so that the electrode balloon catheter has stronger passability in the human body.

[0066] It is understandable that when executing the above method to prepare the electrode balloon catheter, some detailed designs and specific matching forms in the preparation process can refer to the structures of the above-mentioned shock wave generating assembly 100 and the electrode balloon catheter, which will not be repeated here.

[0067] By means of the shock wave generating assembly, the electrode balloon catheter and the manufacturing method, the electrode balloon catheter formed can be used. Since the radial dimension of the electrode balloon catheter becomes smaller, the radial dimension of the electrode balloon catheter is closer to the pre-expansion dimension of the balloon 300, thereby improving the passability of the electrode balloon catheter in human body and avoiding the breakage of the electrode balloon catheter when passing through the human body. When the electrode balloon catheter is inserted into the position of the vascular lesion of the human body, the high voltage pulse generated by the high voltage generating device 400 is input to the first electrode 41 and the second electrode 42 through the pad connected by the wire. Through the setting of the through hole 21 and the through hole 411, the two electrodes are connected to the outside, and the space between the two electrodes is filled with the filling liquid, the filling liquid fills the balloon 300, and the reference pressure inside the balloon 300 is 4 atmospheres. After the high voltage generating device 400 emits a high voltage pulse to the first electrode 41 and the second electrode 42, the filling liquid between the first electrode 41 and the second electrode 42 is broken down, so that discharge occurs between the two metal electrodes, and then a violent shock wave and a large number of bubbles are generated in the filling liquid. Furthermore, the energy generated by the shock wave and bubble collapse softens and breaks up the calcified lesions in the blood vessels. At the same time, the balloon 300 expands under the action of the filling fluid, further squeezing the calcified lesions in the blood vessels, thereby achieving the purpose of unblocking the blood vessels and providing sufficient space for the subsequent implantation of vascular stents.

[0068] The embodiments of the present application have been described above, and the above description is exemplary, not exhaustive, and is not limited to the disclosed embodiments. Many modifications and changes will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments. The selection of terms used herein is intended to best explain the principles of the embodiments, practical applications, or improvements to the technology in the market, or to enable other persons of ordinary skill in the art to understand the embodiments disclosed herein.

Claims

1. A shock wave generating assembly, characterized in that: include: A substrate, wherein the substrate is a flexible member; A metal wire layer, located on one side of the substrate; an insulating layer, at least covering the metal wire layer, wherein the insulating layer is made of a flexible material; an electrode pair, along the arrangement direction of the substrate and the insulating layer, the electrode pair is located on at least one side of the insulating layer, the electrode pair is electrically connected to the metal wire layer, The electrode pair includes a first electrode and at least one second electrode, the first electrode and the second electrode are arranged with spacing through the insulating layer, and in a projection of the electrode pair toward the substrate, at least part of the first electrode and at least part of the second electrode are exposed from the insulating layer.

2. The shock wave generating assembly according to claim 1, characterized in that: Along the arrangement direction of the substrate and the insulating layer, the first electrode is located on a side of the insulating layer away from the substrate, the second electrode is at least partially located on a side of the substrate facing the insulating layer, and the insulating layer is provided with a through hole corresponding to the position of the second electrode for exposing at least a portion of the second electrode.

3. The shock wave generating assembly according to claim 2, characterized in that: The substrate is provided with a recess, the second electrode is at least partially connected to the recess, and along the arrangement direction of the substrate and the insulating layer, the through hole is located in the shadow range formed by the recess.

4. The shock wave generating assembly according to claim 3, characterized in that: Along the arrangement direction of the substrate and the insulating layer, the depth of the recess is no more than one third of the thickness of the substrate.

5. The shock wave generating assembly according to claim 3, characterized in that: The second electrode includes a connected connection part and a reaction part, the connection part is connected to the recess, the reaction part extends out of the insulating layer through the through hole, so that part of the reaction part is arranged in the same layer as the first electrode, and the first electrode and the reaction part are gap-matched.

6. The shock wave generating assembly according to claim 4, characterized in that: The first electrode has a through hole, and along the arrangement direction of the substrate and the insulating layer, the through hole at least covers the through hole.

7. The shock wave generating assembly according to any one of claims 1 to 6, characterized in that: The second electrode includes two or more electrodes. The insulating layer covers the substrate, the first electrode covers a portion of the insulating layer, and along a projection direction of the insulating layer onto the substrate, a plurality of the second electrodes are arranged at intervals in the first electrode.

8. The shock wave generating assembly according to any one of claims 1 to 6, characterized in that: A wiring channel is provided on one side of the substrate close to the insulating layer. The metal wire layer includes at least a first electrode wire and a second electrode wire. The first electrode wire and the second electrode wire are arranged in the wiring channel to be connected to the first electrode and the second electrode respectively.

9. The shock wave generating assembly according to any one of claims 1 to 6, characterized in that: The shock wave generating component further comprises at least one pad, which is electrically connected to the metal wire layer, and along the arrangement direction of the substrate and the insulating layer, the pad is exposed through the insulating layer.

10. The shock wave generating assembly according to any one of claims 1 to 6, characterized in that: The flexible material of the substrate includes polyvinyl alcohol, polyester and polyimide.

11. An electrode balloon catheter, characterized in that: include: Internal catheter; At least one shock wave generating assembly, wherein the shock wave generating assembly is a shock wave generating assembly according to any one of claims 1 to 10, the shock wave generating assembly is enclosed in the circumference of the inner conduit, and a plurality of the shock wave generating assemblies are arranged along the axial direction of the inner conduit; The balloon is sleeved on the outer wall of the inner catheter and at least covers the shock wave generating component.

12. The electrode balloon catheter according to claim 11, characterized in that: The second electrodes in the shock wave generating assembly include more than two, and the plurality of second electrodes are evenly arranged along the circumference of the inner conduit.

13. The electrode balloon catheter according to claim 12, characterized in that: Along the radial direction of the inner conduit, the thickness of the shock wave generating assembly in the inner conduit does not exceed 0.3 mm. The side of the substrate away from the insulating layer is attached to the surface of the inner conduit, or at least a part of the substrate is embedded in the outer wall of the inner conduit.

14. A method for manufacturing an electrode balloon catheter, characterized in that: The electrode balloon catheter comprises an inner catheter, at least one shock wave generating component and a balloon, wherein the shock wave generating component is connected to the outer wall of the inner catheter, and the balloon is sleeved on the outer wall of the inner catheter and at least covers the shock wave generating component. The manufacturing method comprises: forming the shock wave generating assembly, wherein the shock wave generating assembly comprises a substrate, a metal wire layer, an insulating layer and an electrode pair, wherein the electrode pair comprises a first electrode and at least one second electrode, wherein the substrate is a flexible member, wherein a metal wire layer and the second electrode and the first electrode electrically connected to the metal wire layer are prepared on the substrate, wherein the first electrode and the second electrode are separated by the insulating layer, wherein the insulating layer at least covers the metal wire layer, and in a projection of the electrode pair toward the substrate, at least a portion of the first electrode and at least a portion of the second electrode are exposed from the insulating layer; and The shock wave generating assembly is mounted on the inner conduit.

15. The manufacturing method according to claim 14, characterized in that: The manufacturing method of installing the shock wave generating assembly on the inner conduit comprises: At least one shock wave generating assembly is installed on the inner conduit, and a plurality of the shock wave generating assemblies are arranged along the axial direction of the inner conduit. When the shock wave generating assembly is installed on the inner conduit, the shock wave generating assembly is prepared into a cylindrical structure that matches the outer wall of the inner conduit and is sleeved on the outer wall of the inner conduit. The second electrodes in the shock wave generating assembly include more than two, and the plurality of the second electrodes are evenly arranged along the circumference of the inner conduit. The substrate is attached to the surface of the inner conduit, or at least a portion of the substrate is embedded in the outer wall of the inner conduit.

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