Shock wave electrode assembly and balloon catheter device

Abstract

The shock wave electrode assembly 100 and the balloon catheter device 300 include the shock wave electrode assembly 100. The shock wave electrode assembly 100 includes an inner electrode 110, an outer electrode 130, and an insulating layer 120 located between the inner electrode 110 and the outer electrode 130. A first hole 112 is provided in the inner electrode 110, a second hole 122 is provided in the insulating layer 120, and a third hole 132 is provided in the outer electrode 130. The diameter of the second hole 122 is equal to or larger than the diameter of the first hole 112, and the diameter of the third hole 132 is equal to or larger than the diameter of the second hole 122. The first hole 112, the second hole 122, and the third hole 132 are sequentially connected to form a cavity 140.

Description

Technical Field

[0001] The present disclosure relates to an electrode assembly, particularly to a shock wave electrode assembly and a balloon catheter device. For all purposes, this application claims the priority of Chinese Patent Application No. 202211718322.0 filed on December 29, 2022, and the content disclosed in the above Chinese patent application is incorporated herein by reference as part of this application.

Background Art

[0002] Atherosclerotic disease is an arterial stenosis and sclerosis disease caused by the accumulation of plaques. Plaques consist of fibrous tissue, fat, and calcium. The accumulated calcified plaques inhibit the normal flow of blood and reduce the supply of oxygen and nutrients to the body. This causes related diseases in the arteries that supply blood to the major parts of the body (including the brain, heart, and limbs). The method of the liquid electric effect is used to destroy the calcified lesion structure attached to the diseased blood vessel wall. That is, an electrode is inserted into an angioplasty balloon and acts together with a high-voltage generator, and can be used in the operation of calcified lesions in the arterial wall. In such an operation, after pushing the balloon catheter along the guide wire to the occluded area, the balloon is pressurized with a conductive fluid to make the balloon adhere to the blood vessel. A series of high-voltage pulses are applied to the electrodes in the balloon by a high-voltage generator, each pulse passes through the electrodes to generate microbubbles in the conductive fluid, these bubbles generate shock waves through growth and instantaneous rupture, and pass through the balloon wall to reach the occluded area.

Summary of the Invention

Means for Solving the Problems

[0003] This disclosure provides a shock wave electrode assembly comprising an internal electrode, an external electrode, and an insulating layer located between the internal electrode and the external electrode. The internal electrode is provided with a first hole, the insulating layer with a second hole, and the external electrode with a third hole, wherein the diameter of the second hole is greater than or equal to the diameter of the first hole, and the diameter of the third hole is greater than or equal to the diameter of the second hole, and the first hole, the second hole, and the third hole are in sequential communication to form a cavity.

[0004] In one embodiment, the diameter of the second hole and / or the third hole is larger than the diameter of the first hole.

[0005] In one embodiment, the diameters of the first, second, and third holes increase in order, and the cavity takes on a flared shape.

[0006] In one embodiment, the axis of the cavity is perpendicular to the outer surface of the external electrode.

[0007] In one embodiment, the axis of the cavity intersects with and is not perpendicular to the outer surface of the external electrode.

[0008] In one embodiment, the internal electrode, insulating layer, and external electrode are all annular and arranged coaxially, the external electrode is placed over the insulating layer, the insulating layer is placed over the internal electrode, and the first, second, and third holes are provided coaxially.

[0009] In one embodiment, the ratio of the thickness of the internal electrode to the thickness of the external electrode is in the range of 1:2-2:1, and the ratio of the thickness of the insulating layer to the thickness of the internal electrode is in the range of 1:2-2:1.

[0010] In one embodiment, the ratio of the diameter of the first hole to the diameter of the second hole is in the range of 1:1-1:5, and the ratio of the diameter of the second hole to the diameter of the third hole is in the range of 1:1-1:5.

[0011] In one embodiment, the ratio of the length of the internal electrode to the length of the insulating layer is in the range of 1:2-1:10, and the ratio of the length of the external electrode to the length of the insulating layer is in the range of 1:1-1:10.

[0012] In one embodiment, the radial cross-sectional shape of the first hole, the second hole, and / or the third hole is a parallelogram, rectangle, trapezoid, or triangle.

[0013] In one embodiment, the shape of the first hole, the second hole, and / or the third hole is cylindrical, frustoconical, or conical.

[0014] In one embodiment, the shape of the radial cross-section of the first hole is a parallelogram, rectangle, trapezoid, or triangle, and the shapes of the radial cross-sections of the second and third holes are independently a parallelogram, rectangle, or trapezoid.

[0015] In one embodiment, the shape of the first hole is cylindrical, frustoconical, or conical, and the shapes of the second and third holes are independently cylindrical or frustoconical.

[0016] This disclosure provides a shock wave electrode assembly comprising an internal electrode, an external electrode, and an insulating layer, wherein the insulating layer is located between the internal electrode and the external electrode, a first hole is provided in the internal electrode, a second hole is provided in the insulating layer, and a third hole is provided in the external electrode, the projected area of ​​the second hole along the axial direction is greater than or equal to the projected area of ​​the first hole along the axial direction, the projected area of ​​the third hole along the axial direction is greater than or equal to the projected area of ​​the second hole along the axial direction, and the first hole, the second hole, and the third hole are in sequential communication to form a cavity.

[0017] In one embodiment, the projected area along the axial direction of the second hole and / or the third hole is larger than the projected area along the axial direction of the first hole.

[0018] In one embodiment, the projected area of ​​the first hole, the second hole, and the third hole increases in order along their respective axial directions, and the cavity exhibits a flared shape.

[0019] In one embodiment, the axis of the cavity intersects the axis of the shock wave electrode assembly.

[0020] This disclosure provides a balloon catheter device comprising a balloon, an inner tube, an outer tube, and at least one of the above-described shock wave electrode assemblies. The distal end of the inner tube extends through the balloon and is connected to the distal end of the balloon, the shock wave electrode assembly is provided on the outer surface of the inner tube located inside the balloon, the outer tube is fitted outside the inner tube, and the distal end of the outer tube is connected to the proximal end of the balloon.

[0021] In one embodiment, the balloon catheter device includes a plurality of shock wave electrode assemblies arranged at intervals along the axial direction of the inner tube, wherein the plurality of shock wave electrode assemblies are arranged in the same circumferential direction of the inner tube or at an angle to the circumferential direction.

[0022] In one embodiment, the axial directions of the cavities of multiple shock wave electrode assemblies are substantially coincide.

[0023] In one embodiment, the shock wave electrode assembly is provided with multiple cavities.

[0024] The shock wave electrode assemblies according to the embodiments of this disclosure have flared cavities, which can reduce shock wave diffusion, focus shock waves, and increase shock wave intensity. At the same time, by changing the direction of the flared opening, the direction of shock wave propagation can be changed, improving the directionality of the shock wave, which is advantageous for targeted therapy of calcified lesions and intravascular calcified lesions. The internal electrodes of the shock wave electrode assemblies according to the embodiments of this disclosure have annular structures, which can realize multiple discharge cavities without increasing the number of internal electrodes, and the annular internal electrodes can also maintain good mechanical strength and are less likely to shift during the discharge process. [Brief explanation of the drawing]

[0025] To more clearly illustrate the technical concepts of the embodiments of this disclosure, the drawings of the embodiments will be briefly described below, and it is clear that the drawings in the following description relate only to some embodiments of this disclosure and do not limit this disclosure. [Figure 1A] Figure 1A is a schematic cross-sectional view of a shock wave electrode assembly according to an embodiment of the present disclosure. [Figure 1B] Figure 1B is a schematic cross-sectional view of a shock wave electrode assembly according to an embodiment of the present disclosure. [Figure 1C] Figure 1C is a schematic cross-sectional view of a shock wave electrode assembly according to an embodiment of the present disclosure. [Figure 1D] Figure 1D is a schematic cross-sectional view of a shock wave electrode assembly according to an embodiment of the present disclosure. [Figure 2] Figure 2 is a perspective schematic view of a shock wave electrode assembly according to an embodiment of the present disclosure. [Figure 3] Figure 3 is an exploded view of the shock wave electrode assembly of Figure 2. [Figure 4] Figure 4 is a schematic view of the flare effect of the cavity of a shock wave electrode assembly according to an embodiment of the present disclosure. [Figure 5] Figure 5 is a schematic view of a balloon catheter device according to an embodiment of the present disclosure. [Figure 6A] Figure 6A is a schematic cross-sectional view of a balloon catheter device according to an embodiment of the present disclosure. [Figure 6B] Figure 6B is a schematic cross-sectional view of a balloon catheter device according to an embodiment of the present disclosure. [Figure 6C] Figure 6C is a schematic cross-sectional view of a balloon catheter device according to an embodiment of the present disclosure. [Figure 7] Figure 7 is a schematic view of a balloon catheter device having a plurality of shock wave electrode assemblies according to some embodiments of the present disclosure.

Mode for Carrying Out the Invention

[0026] Hereinafter, referring to the drawings in the embodiments of the present disclosure, the technical solutions in the embodiments of the present disclosure will be clearly and completely described. Obviously, the described embodiments are only a part of the embodiments of the present disclosure, not all of the embodiments. Based on the embodiments in the present disclosure, all other embodiments obtained by those skilled in the art without creative labor shall fall within the protection scope of the present disclosure.

[0027] Unless otherwise defined, all terms used in the embodiments of this disclosure (including technical and scientific terms) have the same meaning as those commonly understood by those skilled in the art. Furthermore, terms as defined in a standard dictionary should be interpreted to have the same meaning as in the context of the relevant art, unless the embodiments of this disclosure explicitly define them, and should be interpreted without applying idealized or highly formalized meanings.

[0028] The terms “first,” “second,” and similar terms used in the embodiments of this disclosure do not indicate any order, quantity, or importance, but are used to distinguish different components. Similar terms such as “one,” “one,” or “the said” also indicate that there is at least one, not a quantitative limitation. Similarly, similar terms such as “comprising” or “comprising” mean that the element or article appearing before the term includes the element or article and its equivalents listed after the term, and do not exclude other elements or articles. Similar terms such as “connected” or “linked” are not limited to physical or mechanical connections, but may include electrical or communication connections, whether direct or indirect. “Outer surface of external electrode” as defined in this disclosure means the surface of the external electrode away from the internal electrode. “Thickness” as defined in this disclosure means the distance between two opposing surfaces of an object. “Distal end” and “proximal end” as defined in this disclosure describe how the balloon device enters the blood vessels of the human body after passing through the skin of the human body and enters the lesion site along the direction of the blood vessels of the human body. With the entry point through which the human skin is inserted as the reference point, the end of the balloon that is further away from the reference point is designated as the distal end, and the end that is closer to the reference point is designated as the proximal end, along the direction of balloon movement.

[0029] Traditional angioplasty often involves using a balloon catheter to physically expand the lesion (e.g., a calcified lesion) and allow it to pass through the blood vessel. However, the adventitia of the blood vessel is easily torn and damaged during balloon expansion.

[0030] The inventors have found that in some prior art, the liquid electrostatic effect method can be used to destroy calcified lesion structures attached to diseased blood vessel walls. Specifically, by inserting electrodes into an angioplasty-type balloon and using it in conjunction with a high-voltage generator, it can be used in surgery for calcified lesions in arterial walls. However, since the discharge position of general electrode units is often random, the direction of the shock wave due to the discharge is numerous, the intensity is relatively dispersed, and it is difficult to focus. To address these problems, this disclosure provides a shock wave electrode assembly and a balloon catheter device.

[0031] The embodiments and examples of the present disclosure will be described in detail below with reference to the drawings.

[0032] Figures 1A-1D are schematic cross-sectional views of shock wave electrode assemblies according to several embodiments of the present disclosure. Figure 2 is a schematic perspective view of a shock wave electrode assembly according to one embodiment of the present disclosure. Figure 3 is an exploded view of the shock wave electrode assembly of Figure 2.

[0033] As shown in Figures 1A-1D, the shock wave electrode assembly 100 includes an internal electrode 110, an external electrode 130, and an insulating layer 120, the insulating layer 120 being located between the internal electrode 110 and the external electrode 130. A first hole 112 is provided in the internal electrode 110, a second hole 122 is provided in the insulating layer 120, and a third hole 132 is provided in the external electrode 130. The diameter of the second hole 122 is greater than or equal to the diameter of the first hole 112, and the diameter of the third hole 132 is greater than or equal to the diameter of the second hole 122. The first hole 112, the second hole 122, and the third hole 132 are in sequential communication, forming a cavity 140. In one embodiment, the diameters of the second hole and / or the third hole are greater than the diameter of the first hole, in which case the diameter of the first hole is the minimum. In another embodiment, the diameters of the first, second, and third holes increase in order, and the cavity 140 exhibits a flared shape, as shown in the figure. Since the cavity is flared, it can be understood that, along the central axis direction of the cavity, the shape of the cavity generally follows a trend from large to small or small to large. This creates a certain gap between the internal electrode 110 and the external electrode 130, which forms a discharge circuit between the external electrode 130 and the internal electrode 110. When this shock wave electrode assembly is placed in a liquid and an appropriate pulse voltage is applied, the liquid between the internal and external electrodes is disrupted, generating an electric spark and a shock wave. According to embodiments of this disclosure, the first hole 112, the second hole 122, and the third hole 132 can be formed using any suitable physical, chemical, or physicochemical process, such as a mechanical drill, laser drill, or mask and etching process. In this disclosure, "the pore diameter increases sequentially" includes both cases where the pore diameter changes linearly (as shown in Figure 1C, for example) and cases where the pore diameter changes non-linearly.

[0034] This disclosure further provides shock wave electrode assemblies, which can also be referenced to Figures 1A-1D. The shock wave electrode assembly 100 includes an internal electrode 110, an external electrode 130, and an insulating layer 120, the insulating layer 120 being located between the internal electrode 110 and the external electrode 130, the internal electrode 110 having a first hole 112, the insulating layer 120 having a second hole 122, and the external electrode 130 having a third hole 132, the projected area of ​​the second hole 122 along the axial direction being greater than or equal to the projected area of ​​the first hole 112 along the axial direction being greater than or equal to the projected area of ​​the second hole 122 along the axial direction being greater than or equal to the projected area of ​​the second hole 122, the first hole 112, the second hole 122, and the third hole 132 are in sequential communication, forming a cavity 140.

[0035] In one embodiment, the projected area along the axial direction of the second hole 122 and / or the third hole 132 is larger than the projected area along the axial direction of the first hole 112.

[0036] In one embodiment, the projected area of ​​the first hole 112, the second hole 122, and the third hole 132 increases in the axial direction in order, and the cavity 140 exhibits a flared shape.

[0037] In one embodiment, the axis of the cavity 140 intersects the axis of the shock wave electrode assembly 100.

[0038] Depending on the actual needs, the direction of the shock wave can be adjusted by changing the angle of the opening. In one embodiment, the axis of the cavity 140 is perpendicular to the outer surface of the external electrode 130, as shown in Figures 1A, 1B, and 1C. In this case, the shock wave emitted from the cavity 140 propagates mainly in a direction perpendicular to the outer surface of the external electrode 130. In one embodiment, the axis of the cavity 140 intersects with and is not perpendicular to the outer surface of the external electrode 130. In actual surgery, some calcified lesions require targeted treatment with shock waves. In this case, the cavity can be designed so that its axis intersects with and is not perpendicular to the outer surface of the external electrode, and the cavity can be changed to an inclined, flared shape, so that the shock wave generated along the axis of the cavity propagates directionally to the calcified lesion to be treated, as shown in Figure 1D. The shock wave electrode assembly according to this disclosure offers the possibility of targeted treatment of calcified lesions. Depending on the actual situation, the angle between the cavity axis and the outer surface of the external electrode can be adaptively adjusted.

[0039] In one embodiment, as shown in Figures 2 and 3, the internal electrode 110, the insulating layer 120, and the external electrode 130 are all annular. The internal electrode 110, the external electrode 130, and the insulating layer 120 are arranged coaxially, and the external electrode 130 is fitted to the outside of the insulating layer 120, with the inner diameter of the external electrode 130 matching the outer diameter of the insulating layer 120 to reduce the possibility of relative movement between the external electrode 130 and the insulating layer 120. Similarly, the insulating layer 120 is also provided to be fitted to the outside of the internal electrode 110, with the inner diameter of the insulating layer 120 matching the outer diameter of the internal electrode 110 to ensure stability of the discharge process. Referring to Figure 2, the shock wave electrode assembly, including the internal electrode 110, the external electrode 130, and the insulating layer 120, is further fitted to the outside of the inner tube 320. In this embodiment, the axes of the internal electrode 110, the insulating layer 120, and the external electrode 130 are perpendicular to the axes of the first hole 112, the second hole 122, and the third hole 132.

[0040] In one embodiment, the ratio of the thickness of the internal electrode 110 to the thickness of the external electrode 130 is in the range of 1:2-2:1. In one embodiment, the ratio of the thickness of the insulating layer 120 to the thickness of the internal electrode 110 is in the range of 1:2-2:1. According to the embodiments of this disclosure, the insulating layer 120 mainly serves to separate the internal electrode 110 from the external electrode 130. If the thickness of the insulating layer 120 is small, that is, if the distance between the internal electrode 110 and the external electrode 130 is too small, the conductive medium between the internal electrode and the external electrode is easily destroyed, the generated shock wave energy is small, and consequently the internal electrode and the external electrode conduct directly, resulting in no shock wave being generated. If the thickness of the insulating layer 120 is large (for example, if the ratio of the thickness of the insulating layer to the thickness of the internal electrode is greater than 5:1), that is, if the distance between the internal electrode 110 and the external electrode 130 is too large, the conductive medium is less likely to be effectively destroyed, and shock waves are less likely to be effectively generated. In the embodiments of this disclosure, "thickness" refers to the distance between two opposing upper and lower surfaces of an object. Specifically, the thickness of the internal electrode 110, the external electrode 130, or the insulating layer 120 refers to the distance between the opposing inner and outer surfaces that are close to and far from the inner tube 320. The thickness of the external electrode 130 is, for example, the distance between the inner surface of the external electrode 130 that is close to the inner tube 320 and the outer surface that is far from the inner tube 320. The material of the insulating layer 120 is a non-conductive insulator, such as a polymer such as polyimide, polyamide, fluorine-containing polymer (e.g., PTFE, FEP, etc.), poly(ether block amide), polyethylene, or polypropylene. Furthermore, the thickness of the insulating layer 120 is related to the dielectric constant of the insulating material. A high dielectric constant provides good insulating performance, and in the same case, a thin insulating layer 120 can satisfy the requirements, for example, a polyamide material with a high dielectric constant. Therefore, depending on the actual situation, insulating layers can be made using insulating materials with different dielectric constants, and the thickness ratio of the internal electrode 110, insulating layer 120, and external electrode 130 will also change accordingly. Furthermore, the materials of the external electrode 130 and the internal electrode 110 may be conductive metals such as stainless steel, copper, silver, or gold.

[0041] In some embodiments, the length of the internal electrode 110 and the length of the insulating layer 120 are in a ratio of 1:2 to 1:10. If the length of the internal electrode 110 is too short, the internal electrode 110 is more likely to undergo translational motion relative to the insulating layer 120. If the length of the internal electrode 110 is too long, it affects the transport of the balloon catheter within the patient's body and also increases material costs. Therefore, the length of the external electrode 130 can be adjusted accordingly depending on the actual situation, and this disclosure is not limited thereto. In some embodiments, the length of the external electrode 130 and the length of the insulating layer 120 are in a ratio of 1:1 to 1:10. According to embodiments of this disclosure, if the length of the external electrode 130 is too long, it affects the passability of the balloon catheter. Therefore, the length of the internal electrode 110 can be adjusted accordingly depending on the actual situation, and this disclosure is not limited thereto. According to embodiments of this disclosure, since the length of the external electrode 130 is smaller than the length of the insulating layer 120, it can be better fixed to the insulating layer 120. In the embodiments of this disclosure, the length of the internal electrode 110, the external electrode 130, or the insulating layer 120 refers to the distance between the opposing ends along the axial direction of the shock wave electrode assembly 100.

[0042] In one embodiment, the first hole 112, the second hole 122, and the third hole 132 are provided coaxially, and the insulating layer is located between the internal electrode 110 and the external electrode 130, so that a certain gap is formed between the external electrode 130 and the internal electrode 110, and this gap is advantageous for uniform discharge. In one embodiment, the range of the ratio of the hole diameter of the second hole 122 to the hole diameter of the third hole 132 is 1:1-1:5. In one embodiment, the range of the ratio of the hole diameter of the first hole 112 to the hole diameter of the second hole 122 is 1:1-1:5. In a typical electrode unit, due to the randomness of the discharge position, there are many directions in which shock waves are generated, and the intensity is relatively dispersed. According to the shock wave electrode assembly of the embodiment of this disclosure, the hole diameters of the first hole 112 in the internal electrode 110, the first hole 122 in the insulating layer 120, and the third hole 132 in the external electrode 130 increase in order, so that the cavity 140 has a flared structure that is narrow at one end and wide at the other end. This flared structure can partially reflect diffused sound waves, concentrate energy, reduce diffusion loss, and superimpose wave amplitudes, thereby increasing the intensity of the shock wave and allowing it to propagate over longer distances.

[0043] In one embodiment, the cross-sectional shapes of the first hole 112, the second hole 122, and the third hole 132 may be other shapes, such as elliptical, in addition to the circular structure shown in the illustrated embodiment. Furthermore, the structure of the holes in the internal electrode 110, the external electrode 130, and the insulating layer 120 may be other shapes, and in one embodiment, the radial cross-sectional shapes of the first hole 112, the second hole 122, and the third hole 132 are parallelograms, rectangles, trapezoids, or triangles.

[0044] Here, the radial cross-section is any cross-section where the axis of the cavity is located. In one embodiment, the shapes of the first hole 112, the second hole 122 and / or the third hole 132 are cylindrical, frustoconical, or conical. When the radial cross-sectional shapes of the first hole 112, the second hole 122 and the third hole 132 are all rectangular, this is when the shapes of the first hole 112, the second hole 122 and the third hole 132 are all cylindrical, as shown in Figure 1A. To understand this, a hole having a cylindrical shape may be a typical cylinder or a slanted cylinder, that is, when the axis of the cylinder and the plane on which both ends of the cylinder are located are not perpendicular. When the radial cross-sectional shapes of the first hole 112, the second hole 122, and the third hole 132 are all parallelograms, the shapes of the first hole 112, the second hole 122, and the third hole 132 are all obliquely cut cylinders, as shown in Figure 1D. Preferably, in one embodiment, the radial cross-sectional shapes of the first hole 112 of the internal electrode 110, the second hole 122 of the insulating layer 120, and the third hole 132 of the external electrode 130 are all trapezoidal, as shown in Figure 1C, that is, the shapes of the first hole 112 of the internal electrode 110, the second hole 122 of the insulating layer 120, and the third hole 132 of the external electrode 130 are all frustum-shaped. Such a structure has a more regular flared shape, which promotes the flared concentration effect of the shock wave and can improve the directionality and intensity of the shock wave. In principle, the length of the flared shape and the width of the flared opening greatly affect the cohesive effect of the flared shape; the longer the flared shape and the narrower the opening, the better the cohesive effect can be achieved. In some embodiments of this disclosure, by increasing the thickness of the internal electrode 110, the insulating layer, and the external electrode 130, or by decreasing the diameter of the third hole 132 of the external electrode 130, the diffusion propagation of the shock wave can be reduced, the cohesive effect on the shock wave can be increased, and the shock wave intensity can be improved.

[0045] According to embodiments of this disclosure, a discharge circuit is formed between the external electrode 130 and the internal electrode 110. When the shock wave electrode unit 100 is placed in a liquid and an appropriate pulse voltage is applied, the filling liquid is destroyed, an electric spark is generated, and a shock wave is produced. This shock wave collides with the balloon wall and calcified areas due to the propagation of the liquid inside the balloon. Repeated pulses destroy the structure of the calcified foci, and narrowed blood vessels can be dilated without damaging the surrounding soft tissue. The first hole 112 of the internal electrode 110, the second hole 122 of the insulating layer, and the third hole 132 of the external electrode 130 constitute a cavity 140 having a flared structure that is narrow at one end and wide at the other. As shown in Figure 4, this structure partially reflects diffused sound waves, concentrates energy, reduces diffusion loss, and superimposes the amplitude of the waves, thus increasing the shock wave intensity and allowing it to propagate to a greater distance. Furthermore, the flared shape allows the direction of the shock wave to be adjusted by changing the structure.

[0046] Figure 5 is a schematic diagram of a balloon catheter device according to one embodiment of the present disclosure. As shown in Figure 5, the balloon catheter device 300 includes a terminal 310, an inner tube 320, a balloon 330, an outer tube 350, and a shock wave electrode assembly 200. As described above, the shock wave electrode assembly 200 includes an internal electrode 210, an external electrode 230, and an insulating layer 220, the insulating layer 220 being located between the internal electrode 210 and the external electrode 230. The first hole 112, the second hole 122, and the third hole 132 are provided on the internal electrode 210, the insulating layer 220, and the external electrode 230, respectively. Details of the shock wave electrode assembly have been described above and will not be explained here. The distal end of the inner tube 320 extends through the balloon 330 and is connected to the distal end and terminal 310 of the balloon 330. The shock wave electrode assembly 200 is provided on the outer surface of the inner tube 320 located on the balloon 330. The outer tube 350 is fitted over the outside of the inner tube 320, and the distal end of the outer tube 350 is connected to the proximal end of the balloon 330. The interior of the inner tube 320 is a guidewire cavity through which the guidewire passes during surgery, and the gap between the inner tube 320 and the outer tube 350 constitutes a fluid-passing cavity. The interior of the balloon 330 may be filled with conductive fluid via a fluid-passing chamber. In one embodiment, as shown in Figure 5, the balloon catheter device 300 further includes a guidewire 340 extending along the axial direction of the balloon catheter device 300, the guidewire 340 including a first guidewire 340A and a second guidewire 340B. A first conductor 340A is connected to an internal electrode 210, and a second conductor 340B is connected to an external electrode 230. The two conductors extend along the axial direction of the balloon catheter device 300 and are connected to a high-voltage generator (not shown). Current is transmitted to the internal electrode 210 via the first conductor 340A, where the internal electrode 210, along with the filled conductive fluid and the external electrode 230, forms a circuit. The high-voltage pulse disrupts the conductive fluid, generating a shock wave in the axial direction of the cavity 140. The current is then transmitted to the external electrode 230 and returns to the high-voltage generator along the second conductor 340B. The shock wave electrode assembly described above is arranged inside the balloon of the balloon catheter device according to an embodiment of the present disclosure, which can efficiently generate shock waves, rupture calcified lesions in blood vessels, and effectively improve the therapeutic effect of occluded lesions.Simultaneously, by adjusting the direction of the flared opening and changing the direction of the shock wave, it is possible to treat calcified lesions.

[0047] Figure 6A is a schematic cross-sectional view of a balloon catheter device according to an embodiment of the present disclosure. Referring to Figures 3, 5, and 6A, the assembly process of the shock wave electrode assembly 200 in the balloon catheter device 300 will be explained. In order to attach the shock wave electrode assembly to the balloon catheter device, first the internal electrode 210 is fitted onto the inner tube 320 and the internal electrode 210 and the inner tube 320 are fixed with adhesive. Next, the insulating layer 220 having a second hole 222 is fitted onto the internal electrode 210, the insulating layer 220 is moved to align the first hole 222 with the first hole 212 of the internal electrode 210, the two holes are made coaxial, and the inner tube 320 and the insulating layer 220 are fixed with adhesive. Next, the external electrode 230 is fitted onto the outside, the second hole 232 is moved to align with the first hole 222, and the two holes are made coaxial, thereby forming a cavity 140 with the first hole 212, the second hole 222, and the third hole 232 coaxial, and the external electrode 230 is fixed to the insulating layer 220 with adhesive. In this embodiment, the axes of the internal electrode 210, the insulating layer 220, and the external electrode 230 are perpendicular to the axes of the first hole 212, the second hole 222, and the third hole 232. Since the inner tube, internal electrode, insulating layer, and external electrode all have a circular cross-section, this design reduces the difficulty of assembling the shock wave electrode assembly in the balloon catheter, simplifies the process, and makes it easier to manufacture balloon catheter devices at low cost. In one embodiment, the shock wave electrode assembly is provided with multiple cavities, specifically, multiple first holes 212 are arranged in the internal electrode, multiple second holes 222 are arranged in the insulating layer 220, and multiple third holes 232 are arranged in the external electrode 230. The number of first holes 222, second holes 232, and third holes 232 are equal. Considering that in actual surgery it may be necessary to treat multiple calcified lesions in the circumferential direction of a blood vessel, if a balloon catheter device with one shock wave electrode assembly is used, multiple calcified lesions must be treated one by one. Therefore, a structure having multiple shock wave electrode assemblies can be adopted, creating multiple discharge areas in the balloon catheter device and giving the balloon catheter device the ability to treat multiple calcified lesions simultaneously. Furthermore, the arrangement of multiple shock wave electrode assemblies improves the uniformity of the spatial distribution of shock waves in the circumferential direction of the inner tube, which is advantageous for treating calcified lesions.Figures 6A, 6B, and 6C show schematic cross-sectional views of balloon catheter devices with shock wave electrode assemblies having one, two, or four cavities, respectively. The circumferential distribution of the inner tube 320 of the shock wave electrode assembly is adjusted accordingly to adapt to the actual location distribution of calcified lesions awaiting treatment, but this disclosure is not limited thereto.

[0048] In one embodiment, the balloon catheter device 300 includes a plurality of shock wave electrode assemblies 200 arranged at intervals along the axial direction of the inner tube 320. When multiple calcified lesions are required in actual surgery and these lesions are located at a certain distance apart, employing a balloon catheter device with a single shock wave electrode assembly 200 would require transporting the balloon catheter device to the location of each calcified lesion and processing them one by one, which would be inconvenient for the physician. In response to this, a balloon catheter device having multiple shock wave electrode assemblies 200 arranged at intervals along the axial direction of the inner tube can be employed, and Figure 7 shows a schematic diagram of a balloon catheter device having three shock wave electrode assemblies 200. The balloon surrounds a catheter extending axially, and the inside of the balloon may be filled with a conductive fluid through a fluid-permeable cavity. Referring to Figure 7, the three shock wave electrode assemblies 200 (200A, 200B, and 200C) are arranged at regular intervals on the outer surface of the inner tube 320 and transmit current by connecting two conductors. Here, the first conductor 340A is connected to the internal electrodes 210A, 210B, and 210C, and the second conductor 340B is connected to the external electrodes 230A, 230B, and 230C, thereby forming a discharge circuit between the internal and external electrodes of each shock wave electrode assembly 200 and generating shock waves. Specifically, a first shock wave is generated in the axial direction of the cavity 240A of the shock wave electrode unit 200A, a second shock wave is generated in the axial direction of the cavity 240B of the shock wave electrode unit 200B, and a third shock wave is generated in the axial direction of the cavity 240C of the shock wave electrode unit 200C. Using a similar connection method, multiple shock wave electrode assemblies can be placed inside a balloon, and shock waves can be generated in the axial direction of the cavity of the shock wave electrode assembly 200. Simultaneously, the axial distribution of the inner tubes 320 of different shock wave electrode assemblies 200 is adjusted accordingly based on the actual location distribution of calcified lesions awaiting treatment, and this disclosure does not limit this. In one embodiment, the axial directions of the cavities of multiple shock wave electrode assemblies are substantially coincide.For example, if a calcified lesion area exists along the axial direction of the blood vessel wall, the axial direction of the cavity of multiple shock wave electrode assemblies, which are spaced apart along the axial direction of the inner tube, can be directed almost coincidentally to the calcified lesion area. This allows for targeted shock wave therapy to be performed on the calcified lesion area, significantly improving the therapeutic effect.

[0049] In one embodiment, the multiple shock wave electrode assemblies 200 are arranged in the same circumferential direction of the inner tube 320, or at an angle in the circumferential direction. In a balloon catheter device provided with multiple shock wave electrode assemblies 200, the relative arrangement direction between the shock wave electrode assemblies 200 affects the intensity and distribution of the shock waves generated by the entire balloon. Depending on the location of the calcified lesion to be treated in surgery, the multiple shock wave electrode assemblies 200 can be arranged in the same circumferential direction of the inner tube 320, or at an angle in the circumferential direction, and this disclosure is not limited thereto. Figure 7 is a schematic diagram of a balloon catheter device in which three shock wave electrode assemblies 200A, 200B, and 200C are arranged at 90-degree intervals along the circumferential direction of the inner tube 320, that is, the projections of the three shock wave electrode assemblies in a projection plane perpendicular to the central axis of the inner tube do not overlap. In the embodiments of this disclosure, by employing multiple shock wave electrode assemblies, the balloon catheter device is equipped with the ability to treat multiple calcified lesions simultaneously, and the positions of the multiple shock wave electrode assemblies 200 can be arranged in correspondence with the locations of the multiple calcified lesions to be treated. For example, by arranging them in the same direction circumferentially or sequentially at a certain angle apart, the therapeutic effect on occluded lesions is improved, surgical time is saved, and efficiency is increased.

[0050] The discharge locations of conventional electrode assemblies are usually highly random, resulting in multiple directions for generating shock waves, making focusing difficult, relatively dispersed in intensity, and significant dissipation of shock waves during propagation, which is unfavorable for targeted treatment of lesions. The shock wave electrode assembly according to the embodiment of this disclosure has a flared cavity structure, which can reduce shock wave diffusion, focus shock waves, and increase shock wave intensity. At the same time, by changing the flared structure, specifically by adjusting the direction in which the flare opens, the propagation direction of shock waves generated from the cavity of the shock wave electrode assembly can be changed. Such a design improves the directionality of shock waves and is advantageous for targeted treatment of calcified lesions and intravascular calcified lesions. The internal electrode of the shock wave electrode assembly according to the embodiment of this disclosure has an annular structure, which allows for the realization of multiple discharge cavities without increasing the number of internal electrodes, and the annular internal electrode can also maintain good mechanical strength and is less prone to displacement during the discharge process.

[0051] The following points will be explained. (1) The drawings of the embodiments of this disclosure relate only to the structures relating to the embodiments of this disclosure, and other structures may refer to conventional designs. (2) The embodiments and features of the embodiments herein can be combined to obtain new embodiments, provided they do not contradict each other.

[0052] The above are merely specific embodiments of the present disclosure, and the scope of protection of the present disclosure is not limited thereto; the scope of protection of the present disclosure should be based on the scope of protection of the claims described above.

Claims

1. A shock wave electrode assembly, It includes an internal electrode, an external electrode, and an insulating layer located between the internal electrode and the external electrode. The internal electrode is provided with a first hole. A second hole is provided in the insulating layer. A third hole is provided in the external electrode. The diameter of the second hole is greater than or equal to the diameter of the first hole. The diameter of the third hole is greater than or equal to the diameter of the second hole. A shock wave electrode assembly characterized in that the first hole, the second hole, and the third hole are sequentially connected to form a cavity.

2. The shock wave electrode assembly according to claim 1, characterized in that the diameter of the second hole and / or the third hole is larger than the diameter of the first hole.

3. The shock wave electrode assembly according to claim 1, characterized in that the diameters of the first hole, the second hole, and the third hole increase in order, and the cavity exhibits a flared shape.

4. The shock wave electrode assembly according to any one of claims 1 to 3, characterized in that the axis of the cavity is perpendicular to the outer surface of the external electrode.

5. The shock wave electrode assembly according to any one of claims 1 to 3, characterized in that the axis of the cavity intersects with and is not perpendicular to the outer surface of the external electrode.

6. The shock wave electrode assembly according to any one of claims 1 to 3, characterized in that the internal electrode, the insulating layer, and the external electrode are all annular and coaxially arranged, the external electrode is fitted outside the insulating layer, the insulating layer is fitted outside the internal electrode, and the first hole, the second hole, and the third hole are provided coaxially.

7. The shock wave electrode assembly according to any one of claims 1-3, characterized in that the ratio of the thickness of the internal electrode to the thickness of the external electrode is in the range of 1:2-2:1, and the ratio of the thickness of the insulating layer to the thickness of the internal electrode is in the range of 1:2-2:

1.

8. The shock wave electrode assembly according to any one of claims 1 to 3, characterized in that the ratio of the hole diameter of the first hole to the hole diameter of the second hole is in the range of 1:1 to 1:5, and the ratio of the hole diameter of the second hole to the hole diameter of the third hole is in the range of 1:1 to 1:

5.

9. The shock wave electrode assembly according to any one of claims 1 to 3, characterized in that the ratio of the length of the internal electrode to the length of the insulating layer is in the range of 1:2 to 1:10, and the ratio of the length of the external electrode to the length of the insulating layer is in the range of 1:1 to 1:

10.

10. The shock wave electrode assembly according to any one of claims 1-3, characterized in that the radial cross-sectional shape of the first hole, the second hole and / or the third hole is a parallelogram, rectangle, trapezoid, or triangle.

11. The shock wave electrode assembly according to any one of claims 1-3, characterized in that the shape of the first hole, the second hole and / or the third hole is cylindrical, frustoconical, or conical.

12. A shock wave electrode assembly, It includes an internal electrode, an external electrode, and an insulating layer located between the internal electrode and the external electrode. The internal electrode is provided with a first hole. A second hole is provided in the insulating layer. A third hole is provided in the external electrode. The projected area of ​​the second hole along the axial direction is greater than or equal to the projected area of ​​the first hole along the axial direction. The projected area of ​​the third hole along the axial direction is greater than or equal to the projected area of ​​the second hole along the axial direction. A shock wave electrode assembly characterized in that the first hole, the second hole, and the third hole are sequentially connected to form a cavity.

13. The shock wave electrode assembly according to claim 12, characterized in that the projected area of ​​the second hole and / or the third hole along the axial direction is greater than the projected area of ​​the first hole along the axial direction of the first hole.

14. The shock wave electrode assembly according to claim 12, characterized in that the projected area of ​​the first hole, the second hole, and the third hole increases in order along their respective axial directions, and the cavity exhibits a flared shape.

15. The shock wave electrode assembly according to any one of claims 12-14, characterized in that the axis of the cavity intersects with the axis of the shock wave electrode assembly.

16. A balloon catheter device, The assembly comprises a balloon, an inner tube, an outer tube, and at least one shock wave electrode assembly according to any one of claims 1-3, 12-14, The distal end of the inner tube extends through the balloon and is connected to the distal end of the balloon. The shock wave electrode assembly is provided on the outer surface of the inner tube in the balloon, The outer tube is fitted to the outside of the inner tube, A balloon catheter device characterized in that the distal end of the outer tube is connected to the proximal end of the balloon.

17. The inner tube comprises a plurality of shock wave electrode assemblies arranged at intervals along the axial direction, The balloon catheter device according to claim 16, characterized in that the plurality of shock wave electrode assemblies are arranged in the same circumferential direction of the inner tube, or arranged at an angle in the circumferential direction.

18. The balloon catheter device according to claim 17, characterized in that the axial directions of the cavities of the plurality of shock wave electrode assemblies are substantially coincide.

19. The balloon catheter device according to claim 18, characterized in that a plurality of cavities are provided in the shock wave electrode assembly.

Images