Outer electrode, electrode assembly, shockwave balloon catheter, and shockwave balloon catheter system

Abstract

This application provides an external electrode, an electrode assembly, a shockwave balloon catheter, and a shockwave balloon catheter system. The external electrode includes a body configured to surround at least a portion of the outer periphery of the inner tube of the shockwave balloon catheter in a circumferential direction. The body has a first end and a second end that are disconnected in the circumferential direction. The curvature of the body is elastically adjustable to change the distance between the first end and the second end. The body includes a discharge section configured to surround a portion of the outer periphery of the inner tube of the shockwave balloon catheter in a circumferential direction and having a discharge edge; and a mounting section, one end of which is connected to the discharge section. The center of the discharge section is offset relative to the center of the mounting section in a first length direction along the length of the shockwave balloon catheter. This achieves better permeability while ensuring the therapeutic effect of shockwave therapy.

Description

Technical Field

[0001] This application relates to the field of interventional therapy technology, specifically to an external electrode, electrode assembly, shockwave balloon catheter, and shockwave balloon catheter system for a shockwave balloon catheter. Background Technology

[0002] Cardiovascular disease has long been a leading cause of death worldwide, with atherosclerosis, caused by atherosclerotic plaque buildup, having an extremely high mortality and disability rate. Plaques in the blood vessel walls are composed of fat, cholesterol, calcium, thrombi, connective tissue, and other blood substances. Traditional treatments for vascular calcification-induced stenosis include using high-pressure balloons or scoring balloons to open the narrowed lesions with significant pressure, and also using methods such as rotary ablation or laser ablation to open the narrowed area. However, these treatments carry high clinical risks and postoperative complications, and their therapeutic effects are not ideal.

[0003] In recent years, intravascular lithotripsy (IVL), derived from extracorporeal shock wave lithotripsy in urology, has been widely used in the treatment of vascular calcification lesions. Compared with traditional treatment methods, IVL can efficiently and safely destroy superficial and deep calcifications by emitting unfocused, circular and pulsed shock waves to the lesion site, thereby improving vascular compliance and achieving the purpose of treatment.

[0004] Shockwave balloon catheters can generate shockwaves within blood vessels to break up calcified tissue. Reducing the diameter of the shockwave balloon catheter allows it to navigate more complex vascular environments, improving treatment effectiveness. However, commercially available shockwave balloon catheters often have relatively long electrodes, which affects their passage through tortuous blood vessels. Utility Model Content

[0005] To at least partially address the problems existing in the prior art, one aspect of this application provides an external electrode for a shockwave balloon catheter. The external electrode includes a body configured to surround at least a portion of the outer periphery of the inner tube of the shockwave balloon catheter in a circumferential direction. The body has a first end and a second end that are disconnected in the circumferential direction. The curvature of the body is elastically adjustable to change the distance between the first end and the second end. The body includes: a discharge portion configured to surround a portion of the outer periphery of the inner tube of the shockwave balloon catheter in a circumferential direction and having a discharge edge; and a mounting portion, one end of which is connected to the discharge portion, wherein the center of the discharge portion is offset relative to the center of the mounting portion in a first length direction in the length direction of the shockwave balloon catheter.

[0006] For example, the discharge section has a first side and a second side opposite to each other in the circumferential direction, wherein: a mounting section is connected to one of the first side and the second side, and a first end and a second end are respectively located on the other of the first side and the second side, and on the mounting section.

[0007] For example, both the first side and the second side are connected to mounting parts, and the first end and the second end are located on different mounting parts.

[0008] For example, the connecting portion does not protrude from the discharge portion in the first length direction.

[0009] For example, the discharge section has: a first side and a second side opposite to each other in the circumferential direction, and a third side and a fourth side opposite to each other in the length direction of the shock wave balloon catheter, the third side facing the first length direction, wherein: the first side and the fourth side are connected by an arcuate transition.

[0010] For example, the second side and the fourth side are connected by a circular arc surface transition.

[0011] For example, along the circumferential direction, the size of the discharge section is less than half the circumference of the circle in which the main body is located.

[0012] For example, the first end and the second end are connected to each other by a tenon and mortise structure.

[0013] For example, the external electrode further includes a first elastic portion connected between the first end and the second end.

[0014] For example, the first elastic part is in the shape of a bent strip, and the first elastic part is located in the same plane as the main body and is bent in the length direction of the shock wave balloon catheter.

[0015] For example, the discharge section has a third side and a fourth side opposite to each other along the length direction of the shock wave balloon catheter, the third side facing a first length direction and the fourth side facing a second length direction opposite to the first length direction, and at least a portion of the fourth side forms a discharge edge.

[0016] For example, an external electrode discharge hole is provided in the middle region of the discharge section. The external electrode discharge hole penetrates the discharge section along the radial direction of the shock wave balloon catheter, and the edge of the external electrode discharge hole forms a discharge edge.

[0017] This application also provides an electrode assembly for a shockwave balloon catheter, comprising: an inner electrode for being disposed on the inner tube of the shockwave balloon catheter; the aforementioned outer electrode, disposed outside the inner electrode; and an insulating sleeve sandwiched between the inner electrode and the outer electrode, the insulating sleeve having a sleeve discharge hole extending radially along the shockwave balloon catheter, the sleeve discharge hole exposing the inner electrode, wherein: the exposed portion of the inner electrode and the discharge edge of the outer electrode form a discharge gap.

[0018] For example, the insulating sleeve is broken along the circumferential direction of the shock wave balloon catheter, such that the insulating sleeve is C-shaped and a first gap is formed at the break of the insulating sleeve.

[0019] For example, the two ends of the disconnected insulating sleeve are connected by a second elastic part or tenon structure, which is located within the first gap.

[0020] For example, the inner electrode is disconnected along the circumferential direction of the shock wave balloon catheter, such that the inner electrode is C-shaped and a second gap is formed at the disconnection of the inner electrode.

[0021] For example, the two ends of the disconnected inner electrode are connected by a third elastic part or tenon structure, which is located within the second gap.

[0022] For example, the second gap at least partially exposes the first gap, the disconnected first end and the second end of the outer electrode are spaced apart to form a third gap, the third gap at least partially exposes the second gap, and the outer electrode and / or the inner electrode are connected to wires that pass through the first gap, the second gap and the third gap.

[0023] For example, the electrode assembly includes two external electrodes arranged along the length of the shockwave balloon catheter, with the mounting portions of the two external electrodes offset in opposite directions relative to their respective discharge points, such that the distance between the mounting portions of the two external electrodes is greater than the distance between the discharge portions of the two external electrodes.

[0024] For example, the electrode assembly includes n external electrodes spaced apart and n-1 internal electrodes spaced apart, where n is an integer greater than or equal to 2. Each external electrode and its adjacent external electrode form a discharge interval with the same internal electrode. The external electrode corresponding to only one internal electrode is connected to a wire.

[0025] For example, the electrode assembly includes n-1 external electrodes spaced apart and n internal electrodes spaced apart, where n is an integer greater than or equal to 2. Each internal electrode and its adjacent internal electrode form a discharge interval with the same external electrode, and the internal electrode corresponding to only one external electrode is connected to a wire.

[0026] For example, the number of insulating sleeves is one, and the insulating sleeve is provided with sleeve discharge holes that are the same as the total number of external electrodes and are provided one-to-one.

[0027] For example, the discharge edge of at least one external electrode is offset from the discharge edges of other external electrodes along the circumferential direction of the shock wave balloon catheter.

[0028] For example, when the external electrode includes an external electrode discharge hole, the sleeve discharge hole is aligned with the center of the external electrode discharge hole.

[0029] This application also provides a shockwave balloon catheter, characterized in that it comprises: an inner tube, the lumen of which is used for a guidewire to pass through; an outer tube, which is sleeved on the inner tube and spaced apart from the inner tube; a balloon, which is sleeved on the inner tube and spaced apart from the inner tube, and the balloon is connected to the outer tube; and the aforementioned electrode assembly, which is disposed in the space between the balloon and the inner tube, wherein: the inner electrode of the electrode assembly is disposed on the inner tube.

[0030] For example, the wires of the electrode assembly are close to the inner tube.

[0031] For example, the inner electrode, insulating sleeve, and outer electrode of the electrode assembly are fixed to the inner tube by adhesive.

[0032] For example, the shockwave balloon catheter includes multiple electrode assemblies spaced apart along the length of the inner tube.

[0033] For example, in the case where each electrode assembly includes two external electrodes, the lead wires of the shockwave balloon catheter include a first external lead wire, a second external lead wire, and a series lead wire. The first external lead wire is connected to an external electrode of the proximal electrode assembly; the second external lead wire is connected to an external electrode of the distal electrode assembly; a series lead wire is connected between the external electrodes of adjacent electrode assemblies; and each external electrode is connected to only one lead wire.

[0034] This application also provides a shockwave balloon catheter system, comprising: the aforementioned shockwave balloon catheter; and a main unit, wherein the inner and outer electrodes of the shockwave balloon catheter are electrically connected to the main unit.

[0035] In the above embodiments, the external electrode of this shape can be coupled with another external electrode of the same or similar shape, with their discharge portions offset circumferentially. This allows for multiple unconnected external electrodes to be configured within a shorter length, forming multiple discharge intervals. This results in more shock wave generation sites within a shorter electrode assembly, achieving better permeability while ensuring the effectiveness of shock wave therapy. Furthermore, the curvature of the main body of the external electrode is elastically adjustable. By adjusting the distance between the first and second ends, the external electrode can be in an open state, easily fitted into the installation position. It can deform during fitting to increase its inner diameter and return to its initial size upon reaching the installation position, thus reliably fitting into the installation position. Alternatively, sufficient pressure can be applied to the adhesive to ensure reliable adhesion. Therefore, the external electrode does not require high processing precision, reducing costs. Moreover, the inner diameter of the external electrode can be very close to the outer diameter of its inner portion, allowing for a reduction in the diameter of the shock wave balloon catheter.

[0036] This utility model description introduces a series of simplified concepts, which will be further explained in detail in the detailed description section. This utility model description is not intended to limit the key features and essential technical features of the claimed technical solution, nor is it intended to determine the scope of protection of the claimed technical solution.

[0037] The advantages and features of this utility model will be described in detail below with reference to the accompanying drawings. Attached Figure Description

[0038] The above and other objects, features, and advantages of this application will become more apparent from the more detailed description of the embodiments of this application in conjunction with the accompanying drawings. The accompanying drawings are used to provide a further understanding of the embodiments of this application and form part of the specification. They are used together with the embodiments of this application to explain this application and do not constitute a limitation thereof. In the accompanying drawings, the same reference numerals generally represent the same components or steps.

[0039] Figure 1A A schematic diagram of a shockwave balloon catheter according to a first embodiment of this application is shown;

[0040] Figure 1B It shows according to Figure 1A A perspective view of the shockwave balloon catheter of the illustrated embodiment, in which the balloon and outer tube are concealed;

[0041] Figure 1C It shows according to Figure 1A The front view of the shockwave balloon catheter of the illustrated embodiment, in which the balloon and outer tube are hidden;

[0042] Figure 2A It shows according to Figure 1A A perspective view of the electrode assembly in the illustrated embodiment;

[0043] Figure 2B A perspective view of an electrode assembly according to another embodiment is shown;

[0044] Figure 3 It shows according to Figure 1A A perspective view of the external electrode in the illustrated embodiment from a first-view perspective;

[0045] Figure 4 A perspective view of the external electrode according to the second embodiment of this application is shown from a first perspective.

[0046] Figure 5 A perspective view of the external electrode according to the third embodiment of this application is shown from a first-view perspective;

[0047] Figure 6 A perspective view of the external electrode according to the fourth embodiment of this application is shown from a first-view perspective;

[0048] Figure 7 A perspective view of the external electrode according to the fifth embodiment of this application is shown from a first-view perspective;

[0049] Figure 8 A perspective view of the external electrode according to the sixth embodiment of this application is shown from a first-view perspective;

[0050] Figure 9A It shows according to Figure 1A A perspective view of the external electrode from a second viewpoint in the illustrated embodiment;

[0051] Figure 9B It shows according to Figure 1A A perspective view of the external electrode from a third-angle perspective in the embodiment shown;

[0052] Figure 10 A perspective view of the external electrode according to the seventh embodiment of this application is shown from a first-view perspective;

[0053] Figure 11 A schematic diagram of the electrode assembly arrangement of a shockwave balloon catheter according to the eighth embodiment of this application is shown, wherein the inner tube, outer tube and balloon are concealed;

[0054] Figure 12 It shows according to Figure 11 A cross-sectional view of the shockwave balloon catheter of the illustrated embodiment;

[0055] Figure 13 A cross-sectional view of a shockwave balloon catheter according to a ninth embodiment of this application is shown;

[0056] Figure 14 It shows according to Figure 11 A perspective view of the insulating sleeve in the illustrated embodiment;

[0057] Figure 15 It shows according to Figure 11 A perspective view of the internal electrode in the illustrated embodiment.

[0058] The above figures include the following reference numerals:

[0059] 10. Electrode assembly; 20. Inner tube; 30. Outer tube; 40. Balloon; 50. Wire; 100. Inner electrode; 110. Second gap; 200. Outer electrode; 211. First end; 212. Second end; 213. Outer electrode discharge hole; 214. Discharge part; 2141. Discharge edge; 215. Mounting part; 216. Third side; 217. Fourth side; 218. Arc surface; 220. First elastic part; 230. Third gap; 240. Tenon and mortise structure; 300. Insulating sleeve; 310. Sleeve discharge hole; 320. First gap; 400. Discharge interval. Detailed Implementation

[0060] In the following description, numerous details are provided to enable a thorough understanding of this application. However, those skilled in the art will appreciate that the following description merely illustrates preferred embodiments of the application by way of example only. Furthermore, to avoid confusion with this application, some technical features well-known in the art have not been described in detail.

[0061] Figure 1A This application illustrates an exemplary embodiment of a shockwave balloon catheter. The shockwave balloon catheter may include an inner tube 20, the lumen of which is used for the passage of a guidewire. The shockwave balloon catheter may also include an outer tube 30, which is sleeved on and spaced apart from the inner tube 20. The outer tube 30 may be connected to a balloon 40 of the shockwave balloon catheter, which is sleeved on and spaced apart from the inner tube 20. The shockwave balloon catheter includes an electrode assembly 10 disposed within the space between the balloon 40 and the inner tube 20. The balloon 40 may be filled with a liquid such as saline or a contrast agent, which has low breakdown strength and can serve as a discharge medium. When a shock wave is generated, the inner electrode 100 and the outer electrode 200 can generate a large voltage between each other, and the discharge medium between the inner electrode 100 and the outer electrode 200 can be broken down under this large voltage, generating a discharge and thus forming a shock wave.

[0062] like Figure 2A and Figure 2B As shown, the electrode assembly 10 includes an inner electrode 100 and an outer electrode 200. The inner electrode 100 is disposed on the inner tube 20 of the shock wave balloon catheter, and the outer electrode 200 is disposed on the outside of the inner electrode 100. Figure 3 An exemplary embodiment of an external electrode 200 is shown. The external electrode 200 may include a conductive body configured to surround at least a portion of the outer periphery of the inner tube 20 of the shock wave balloon catheter along its circumferential direction. The body may be made of a conductive material, such as a metal or conductive ceramic, that is resistant to strong impacts. Preferably, the body may be made of 316 stainless steel. Optionally, the body may have a certain degree of elasticity. Optionally, the body may be configured to be larger than a semicircle, allowing it to be clamped onto the inner tube 20. Optionally, the body may also be positioned onto the inner tube 20 by means of adhesive or heat fusion.

[0063] The main body can have a first end 211 and a second end 212 that are disconnected along the circumferential direction. The curvature of the main body can be elastically adjusted to change the distance between the first end 211 and the second end 212. When the distance between the first end 211 and the second end 212 of the outer electrode 200 increases, the inner diameter of the outer electrode 200 also increases, thus allowing it to be easily fitted onto the inner tube 20, the insulating layer, and the inner electrode 100. After the external force on the outer electrode 200 disappears, the distance between the first end 211 and the second end 212 can be restored to its original distance. This significantly reduces the difficulty of installing the outer electrode 200. Optionally, the inner diameter of the outer electrode 200 can be slightly larger than the outer diameter of the portion accommodated within it. During the installation of the outer electrode 200, adhesive can be filled between the outer electrode 200 and the inner portion. After the outer electrode 200 returns to its shape, excess adhesive can be squeezed inward without further inward compressive stress. This avoids the compressive stress of the outer electrode 200 from affecting the structure of the inner electrode 100 or the function of the inner tube 20.

[0064] The main body may include a discharge portion 214 configured to surround a portion of the outer periphery of the inner tube of the shockwave balloon catheter in a circumferential direction, and the discharge portion 214 has a discharge edge 2141. The discharge portion 214 is configured such that, when the outer electrode 200 is mounted onto the shockwave balloon catheter, the discharge edge 2141 forms a discharge gap 400 between it and the inner electrode 100 on the shockwave balloon catheter. The discharge edge and the inner electrode 100 may be spaced apart by an insulating layer that exposes the inner electrode 100, such that sufficient insulation strength can be formed between the outer electrode 200 and the inner electrode 100, except for the discharge edge 2141, allowing the outer electrode 200 to discharge to the inner electrode 100 only through the discharge edge 2141. In some embodiments, the discharge edge 2141 may be configured to have a flat discharge surface. In some embodiments, the discharge edge 2141 may also be curved or have a notch. Optionally, the edge of the notch may form the discharge edge 2141. The discharge interval 400 can be changed by altering the distance from the discharge edge 2141 to the inner electrode 100 exposed outside the insulating layer, thereby adjusting the properties of the shock wave.

[0065] like Figure 3As shown, the main body may further include a mounting portion 215, one end of which is connected to a discharge portion 214, wherein the center of the discharge portion 214 is offset relative to the center of the mounting portion 215 in a first length direction along the length of the shock wave balloon catheter. In the embodiment shown, the mounting portion 215 can be fitted onto the inner tube, fixing the outer electrode to the inner tube 20 and positioning the discharge portion 214 outside the insulating layer. Optionally, the mounting portion 215 can also be fitted onto the insulating layer. In summary, the mounting portion 215 can be fitted onto the inner tube 20 and serve to fix the outer electrode. Optionally, the outer electrode 200 may not be formed by tubular processing, but rather by stamping or cutting sheet metal, allowing for more diverse processing methods and reducing material costs and processing difficulty through appropriate shape design. In some embodiments, the mounting portion may wrap around the inner tube 20 one or more times. In some embodiments, the mounting portion may be a closed structure or an open structure in the circumferential direction.

[0066] For example, the discharge part 214 and / or the mounting part 215 may have a certain degree of elasticity.

[0067] In the above embodiments, the external electrode 200 of this shape can be configured to cooperate with another external electrode 200 having the same or similar shape, with their discharge portions 214 offset circumferentially. This allows for the provision of multiple unconnected external electrodes 200 within a shorter length, forming multiple discharge intervals 400. This results in more shock wave generating sites within a shorter electrode assembly, achieving better permeability while ensuring the effectiveness of shock wave therapy. Furthermore, the curvature of the main body of the external electrode is elastically adjustable. By adjusting the distance between the first and second ends, the external electrode can be in an open state, easily fitted into the installation position. It can deform during fitting to increase the inner diameter and return to its initial size upon reaching the installation position, thus reliably fitting into the installation position. Alternatively, sufficient pressure can be applied to the adhesive to ensure reliable adhesion. Therefore, the external electrode does not require high processing precision, reducing costs. Moreover, the inner diameter of the external electrode can be very close to the outer diameter of its inner portion, allowing for a reduction in the diameter of the shock wave balloon catheter.

[0068] For example, such as Figure 3 As shown, the discharge section 214 may have a first side and a second side opposite to each other along the circumferential direction. In one specific embodiment, the first side is connected to the mounting section 215, and the first end and the second end are respectively located on the first side and the mounting section 215. In another specific embodiment, the second side is connected to the mounting section 215, and the first end and the second end are respectively located on the second side and the mounting section 215.

[0069] like Figure 4 As shown, both the first side and the second side can be connected to a mounting part 215, and the first end and the second end are located on different mounting parts 215.

[0070] For example, the connecting portion does not protrude from the discharge portion 214 in the first length direction. While maintaining the size of the discharge portion 214, this allows the outer electrode to be shorter in the first length direction, improving the passability of the electrode assembly.

[0071] For example, along the circumferential direction, the size of the discharge section 214 is less than half the circumference of the circle containing the main body. Thus, the discharge sections 214 of the two outer electrodes can be staggered in the circumferential direction and overlap in the first length direction, thereby reducing the size of the electrode assembly in the first length direction.

[0072] For example, the discharge section has a third side and a fourth side opposite to each other along the length direction of the shock wave balloon catheter. The third side faces a first length direction, and the fourth side faces a second length direction opposite to the first length direction. At least a portion of the fourth side forms a discharge edge. Thus, the location of the discharge edge is opposite to the location of the mounting section, thereby preventing a weak connection between the discharge section and the mounting section due to discharge ablation.

[0073] For example, an external electrode discharge hole 213 is provided in the middle region of the discharge section 214. The external electrode discharge hole 213 penetrates the discharge section 214 along the radial direction of the shock wave balloon catheter, and the edge of the external electrode discharge hole 213 forms a discharge edge 2141.

[0074] As described above, by way of example, the electrode assembly 10 may further include an insulating sleeve 300 sandwiched between the inner electrode 100 and the outer electrode 200, and the insulating sleeve 300 is provided with a sleeve discharge hole 310 extending in the radial direction of the shock wave balloon catheter. Figure 2A and Figure 2B Perspective views of electrode assemblies from two different embodiments are shown, with the sleeve discharge hole 310 exposing the inner electrode 100. The insulating sleeve 300 separates the other parts of the inner electrode 100 from the outer electrode 200. Since the breakdown voltage of the insulating sleeve 300 is much higher than that of the discharge medium filled in the balloon 40, even if the insulating sleeve 300 separating the inner electrode 100 and the outer electrode 200 is very thin, a breakdown discharge will still occur between the inner electrode 100 and the outer electrode 200 exposed through the sleeve discharge hole 310.

[0075] The size of the sleeve discharge hole 310 is smaller than the size of the outer electrode discharge hole 213, and the centers of the sleeve discharge hole 310 and the outer electrode discharge hole 213 are aligned. The distance between the edges of the sleeve discharge hole 310 and the outer electrode discharge hole 213 is the discharge interval 400. Optionally, the insulating sleeve 300 can only partially cover the inner electrode 100. Except for the exposed part of the sleeve discharge hole 310, the distance between the other parts of the inner electrode 100 and the outer electrode 200 is much larger than the discharge interval 400, so that the breakdown discharge can only be formed at the sleeve discharge hole 310. With the centers of the sleeve discharge hole 310 and the outer electrode discharge hole 213 aligned, even if the discharge interval 400 increases due to ablation of one side of the outer electrode discharge hole 213 after multiple discharges of the inner electrode 100 and the outer electrode 200, the other edges of the outer electrode discharge hole 213 can still meet the discharge requirements at the discharge interval 400 from the inner electrode 100. The size of the external electrode discharge hole 213 is larger than that of the external electrode discharge hole 213, so that the shock wave generated by the discharge will not act on the external electrode 200 as much as possible, and prevent the shock wave from causing the external electrode 200 to peel off.

[0076] For example, when the outer electrode includes an outer electrode discharge hole 213, the sleeve discharge hole 310 is aligned with the center of the outer electrode discharge hole 213. This allows the discharge medium to enter the discharge gap 400 and prevents shock waves from acting on the outer electrode 200.

[0077] For example, the first end 211 and the second end 212 can be connected to each other via a tenon and mortise structure 240. Figure 5 As shown, in Figure 3 Based on the illustrated embodiment, the first end 211 and the second end 212 can be constructed as a complementary tenon and mortise structure 240. The tenon and mortise structure 240 does not need to be perfectly fitted, as long as it provides a limiting function when the distance between the first end 211 and the second end 212 increases. When installing the outer electrode 200B, the positioning effect of the tenon and mortise can be rendered ineffective by misaligning the first end 211 and the second end 212. This allows for a larger distance between the first end 211 and the second end 212, thereby increasing the inner diameter of the outer electrode 200. Once the outer electrode 200B is in place, the tenon and mortise structure 240 can be fitted. During use, there is almost no external force that would cause the first end 211 and the second end 212 to misalign, allowing the outer electrode 200B to be firmly positioned on the inner tube 20, the outer tube 30, and the insulating sleeve 300, and providing a fixing effect on their inner structures. This prevents the structure from peeling off due to shock waves. For other shapes of external electrodes 200C, their first end 211 and second end 212 can also be constructed as a tenon and mortise structure 240, such as... Figure 6 As shown.

[0078] Optionally, to prevent the tenon and mortise structures 240 from misaligning during use, a reasonable design can be used to ensure that the force acting on the first end 211 and the force acting on the second end 212 when the shock wave acts on the external electrode 200 are approximately the same. Optionally, in embodiments where the force of the shock wave acting on the first end 211 and the force acting on the second end 212 are different, the tenon and mortise structures 240 can be engaged with each other in the radial direction to prevent the shock wave from causing the first end 211 and the second end 212 to misalign.

[0079] For example, a first elastic portion 220 is connected between the first end 211 and the second end 212. In some embodiments, the first elastic portion 220 may be separate from the outer electrode 200, for example, by using stamped spring sheets to hook onto the first end 211 and the second end 212 respectively, thereby limiting the distance between the first end 211 and the second end 212. Optionally, the first elastic portion 220 may be connected to the body of the outer electrode 200 and formed by laser cutting, so that the first elastic portion 220 is part of the outer electrode 200. In summary, the first elastic portion 220 allows the distance between the first end 211 and the second end 212 to be increased to a limited extent before the outer electrode 200 is installed in place, so as to facilitate the installation of the outer electrode 200. When the outer electrode 200 is installed in place and the inner electrode 100 and the outer electrode 200 discharge to form a shock wave, the first elastic portion 220 can absorb the shock wave acting on the outer electrode 200 to a certain extent, preventing the shock wave from having an adverse effect on the electrode assembly 10.

[0080] In some exemplary embodiments, the first elastic portion 220 may be attached to the external electrode 200 and bent toward the inner or outer direction of the shockwave balloon catheter to increase elasticity. In some embodiments, the first elastic portion 220 may also be connected to the first end 211 and the second end 212 of the external electrode 200 by means of welding or the like. Exemplarily, the first elastic portion 220 may be in the shape of a bent strip, and the first elastic portion 220 is located in the same plane as the main body and bent toward the length direction of the shockwave balloon catheter. Optionally, as... Figure 8 The external electrode 200E shown has a first elastic portion 220 that can be in the form of a bent strip. The first elastic portion 220 is located in the same plane as the main body and is bent along the length direction of the shockwave balloon catheter. Preferably, the first elastic portion 220 can be formed by creating a pattern on the external electrode 200. Forming methods include, but are not limited to, laser cutting, wire cutting, and etching. Therefore, the first elastic portion 220 does not additionally increase the diameter of the shockwave balloon catheter and does not affect the passage performance of the shockwave balloon catheter. Figure 3 An exemplary embodiment of an external electrode 200D, based on the external electrode 200 of the illustrated embodiment, wherein the first end 211 and the second end 212 are connected by a first elastic portion 220, is as follows: Figure 7 As shown.

[0081] Exemplarily, the main body also includes a first part 214 and a second part 215, which are arranged along the circumferential direction of the shockwave balloon catheter and connected to each other. A first end 211 is located on the first part 214, a second end 212 is located on the second part 215, and an external electrode discharge hole 213 is located on the first part 214. Along the length direction of the shockwave balloon catheter, the size of the first part 214 is larger than the size of the second part 215, and the second part 215 is formed as a clamp for fixing to the shockwave balloon catheter. Figure 9A and Figure 9B for Figure 3 The illustrated embodiment shows a perspective view of the external electrode 200 from another angle. The first portion 214 has a relatively large area, with a sufficiently large region on which the external electrode discharge hole 213 is provided. Optionally, the circumferential dimension of the first portion 214 is no greater than a semicircle, such that the first portions 214 of the plurality of external electrodes 200 can be arranged along the circumferential direction of the shock wave balloon catheter and spaced apart from each other. The arrangement of the plurality of external electrodes 200 will be described in detail below. Thus, the second portion 215 allows the external electrode 200 to be reliably fixed to the shock wave balloon catheter, and the elasticity of the second portion 215 can at least partially offset the impact of the shock wave on the external electrode 200, preventing the external electrode 200 from peeling off from the shock wave balloon catheter when subjected to external force.

[0082] For example, along the length of the shockwave balloon catheter, the body has opposing third sides 216 and fourth sides 217, wherein a second portion 215 is connected to the third side 216. Specifically, the edges of the first portion 214 and the second portion 215 of the outer electrode 200 can be flush, so that the outer electrode 200 has a flat third side 216. This results in higher material utilization during processing.

[0083] For example, the distance from the second portion 215 to the third side 216 is less than the distance to the fourth side 217. Thus, the outer electrode 200 forms a structure that is not symmetrical in the length direction, with a protruding first portion 214 from the fourth side 217 to the third side 216, and the third side 216 forming the aforementioned clamp structure. Optionally, the edge of the clamp may not be flush with the third side 216, allowing the second portion 215 to connect to the middle portion of the first portion 214, resulting in better balance when the outer electrode is fixed to the conduit, thereby improving the stability of the outer electrode fixed to the conduit. Figure 9A and Figure 9B The structure of one embodiment of the external electrode 200 is shown from different angles. Figure 10 The structure of the external electrode 200F in another embodiment is shown.

[0084] For example, the first side and the fourth side 217 are connected by a curved surface 218. A smoother connection avoids sharp protrusions and reduces the possibility of tip discharge in unwanted locations. When the two outer electrodes 200 are fitted together, the curved surface 218 can create a larger gap, preventing discharge caused by insufficient spacing between the two outer electrodes 200. Optionally, the second side and the fourth side 217 can also be connected by a curved surface.

[0085] For example, the electrode assembly includes two external electrodes arranged along the length of the shockwave balloon catheter. The mounting portions of the two external electrodes are offset in opposite directions relative to their respective discharge points, such that the distance between the mounting portions of the two external electrodes is greater than the distance between the discharge portions of the two external electrodes. This allows for a shorter length of the electrode assembly and the arrangement of multiple external electrodes within a shorter length to form multiple discharge intervals. This improves the permeability of the electrode assembly.

[0086] For example, the electrode assembly 10 may include n external electrodes 200 spaced apart and n-1 internal electrodes 100 spaced apart, where n is an integer greater than or equal to 2. Each external electrode 200 and its adjacent external electrode 200 form a discharge interval 400 with the same internal electrode 100. Only one internal electrode 100 of the external electrode 200 is connected to a wire 50. Figure 11 A perspective view of an electrode assembly 10 according to an exemplary embodiment is shown. As shown, an inner electrode 100 may surround an inner tube 20; in other embodiments, the inner electrode 100 may be configured as a C-shape as described above. An insulating sleeve 300 covers the surface of the inner electrode 100, and the insulating sleeve 300 may be configured as a C-shape as shown in the figure, with the opening of the C-shape exposing a portion of the inner electrode 100. Optionally, the insulating sleeve 300 may not have an opening in the circumferential direction. An outer electrode 200 is disposed outside the insulating sleeve 300, and a first portion 214 of the outer electrode 200 may be symmetrically disposed outside the insulating sleeve 300 in the circumferential direction, with a portion of the outer electrode 200 extending beyond the distance between two inner electrodes 100 along the length of the conduit. Figure 12 It shows Figure 11A cross-sectional view of an embodiment is shown. For ease of understanding, the outer electrodes 200 in the figure are referred to as the first outer electrode 200G, the second outer electrode 200H, the third outer electrode 200I, and the fourth outer electrode 200J, as well as the first inner electrode 100A, the second inner electrode 100B, and the third inner electrode 100C. As shown in the figure, the first outer electrode 200G can be connected to the wire 50, and the fourth inner electrode 100 can also be connected to the wire 50. The first outer electrode 200G can discharge to the first inner electrode 100A, and the current is conducted through the first inner electrode 100A and discharged to the second outer electrode 200H. The second outer electrode 200H conducts current and discharges to the second inner electrode 100B, the second inner electrode 100B discharges to the third outer electrode 200I, the third outer electrode 200I discharges to the third inner electrode 100C, and the third inner electrode 100C discharges to the fourth outer electrode 200J. Thus, the multiple discharge gaps are equivalent to being connected in series and can discharge synchronously. It should be clarified that... Figure 12 This illustration only shows one arrangement of the electrode assembly 10 and does not represent the actual dimensions of the product. In the actual product, the spacing between the first external electrode 200G and the second external electrode 200H, the second external electrode 200H and the third external electrode 200I, and the third external electrode 200I and the fourth external electrode 200J is greater than twice the discharge gap, or the gap is filled with insulating material to prevent discharge between adjacent external electrodes 200. In this embodiment, the first external electrode 200G discharges only to the first internal electrode 100A, and the fourth external electrode 200J discharges only to the third internal electrode 100C. Therefore, the first external electrode 200G and the fourth external electrode 200J can be connected to the wire 50. The second external electrode 200H and the third external electrode 200I both discharge with the two internal electrodes 100, which is equivalent to being connected in series in the circuit, and therefore do not require connection to the wire 50. In the embodiment shown in the figure, at least a portion of the external electrode discharge holes 213 of the external electrodes 200 may face different directions than the external electrode discharge holes 213 of the other external electrodes 200. In embodiments not shown, all the external electrode discharge holes 213 of the external electrodes 200 may face the same direction. Optionally, the number of inner electrodes 100 may be one, two, four, or more. The more inner electrodes 100 there are, the higher the voltage required for discharge, and the longer the coverage area of ​​the resulting shock wave along the length of the conduit.

[0087] Exemplarily, the electrode assembly 10 includes n-1 external electrodes 200 spaced apart and n internal electrodes 100 spaced apart, where n is an integer greater than or equal to 2. Each internal electrode 100 and its adjacent internal electrode 100 form a discharge interval 400 with the same external electrode 200. Only one internal electrode 100 corresponding to one external electrode 200 is connected to a wire 50. Figure 11 and Figure 12In a different embodiment, the outer electrode 200 can be constructed in a C-shape, with each outer electrode 200 corresponding to two inner electrodes 100 to form a discharge interval 400. For ease of understanding, the inner electrodes 100 in the figure can be referred to as the fourth inner electrode 100D, the fifth inner electrode 100E, the sixth inner electrode 100F, and the seventh inner electrode 100G. Correspondingly, the outer electrodes 200 in the figure can be referred to as the fifth outer electrode 200K, the sixth outer electrode 200L, and the seventh outer electrode 200M. The fourth inner electrode 100D can discharge only to the first outer electrode 200G; therefore, the fourth inner electrode 100D can be connected to a wire 50. The fourth inner electrode 100D discharges to the fifth outer electrode 200K, the fifth outer electrode 200K transmits and discharges to the fifth inner electrode 100E, the fifth inner electrode 100E discharges to the sixth outer electrode 200L... and the seventh outer electrode 200M discharges to the seventh inner electrode 100G, until a discharge is finally formed between all the inner electrodes 100 and the outer electrodes 200. The seventh inner electrode 100G can be connected to another wire 50 to form a circuit. As shown in the figure, a portion of the inner electrode 100 is constructed to have a greater length, extending beyond the two outer electrodes 200, such that the inner electrode 100 has two regions corresponding to the outer electrode discharge holes 213 of the two outer electrodes 200, respectively. The number of outer electrodes 200 can also be one, two, four, or more. In an embodiment not shown, the outer electrode discharge holes 213 of all outer electrodes 200 can also face the same direction. The more outer electrodes 200 there are, the higher the voltage required for discharge, and the longer the coverage of the resulting shock wave along the length of the conduit. It should be noted that the second portion 215 of each outer electrode 200 is not shown in the figure, but this does not mean that the outer electrodes 200 of the actual product do not have a second portion 215.

[0088] For example, the number of insulating sleeves 300 can be one. Discharge between the outer electrode 200 and the inner electrode 100 can be achieved solely through the sleeve discharge holes 310 on the insulating sleeve 300. Outside of the sleeve discharge holes 310, the inner electrode 100 and the outer electrode 200 can be completely isolated. The insulating sleeve 300 can extend between multiple inner electrodes 100 and outer electrodes 200 without causing short circuits between adjacent inner electrodes 100 and adjacent outer electrodes 200. As described above, the discharge interval 400 can be determined by the sleeve discharge holes 310 of the insulating sleeve 300 and the outer electrode discharge holes 213 of the outer electrode 200. Therefore, the insulating sleeve 300 can be provided with the same total number of sleeve discharge holes 310 as the number of outer electrodes 200, and these holes are arranged in a one-to-one correspondence. Using a single insulating sleeve 300 can significantly reduce the number of times the insulating sleeve 300 needs to be cut during production, simplifying the production process, significantly reducing costs, and shortening production time.

[0089] In some embodiments, the external electrode discharge holes 213 of the multiple external electrodes 200 can be arranged on one side of the shockwave balloon catheter. This allows the shock wave to be emitted in only one direction, resulting in a higher intensity of the localized shock wave. For example, the external electrode discharge holes 213 of the external electrodes 200 are staggered along the circumferential direction of the shockwave balloon catheter. This allows for more directions of shock wave emission. Compared to the shock wave intensity, which can be changed by adjusting the discharge parameters, the direction of the shock wave requires the operator to rotate the electrode assembly 10, and may even require depressurizing the balloon 40, rotating the entire shockwave balloon catheter, and then refilling the balloon 40 before discharging, making the operation complex. By designing the electrode assembly 10 with multiple external electrode discharge holes 213 staggered along the circumferential direction, the complexity of the operator's operation can be reduced, and the treatment effect can be improved.

[0090] For example, the external electrodes are configured in pairs, and when the external electrodes include clamps, the clamps for each pair of electrodes are respectively disposed at opposite ends of that pair of electrodes. Return to Reference Figure 1B and Figure 1C An electrode assembly may include two external electrodes. Since clamps surround the shockwave balloon catheter, the two clamps are positioned at opposite ends, causing the first portions of the external electrodes to face each other. The first portion of each of the two external electrodes has two edges along the circumferential direction. The two edges of the first external electrode are spaced apart from the two edges of the second external electrode, and the spacing can be greater than twice the discharge interval. Optionally, the spaced edges can be filled with a material that enhances insulation, such as insulating adhesive, and the edges of the external electrodes can be covered. As described above, the first end 211 and the fourth side 217 are connected by an arc surface 218. The edges of one pair of external electrodes can be spaced further apart by the arc surface 218, thereby preventing discharge from occurring due to insufficient spacing between the two external electrodes 200. The spacing between the clamp formed by the second portion of the first external electrode and the first portion of the second external electrode can also be greater than twice the discharge interval. Thus, it is possible to achieve the aforementioned arrangement where the multiple external electrode discharge holes 213 are staggered along the circumferential direction. The paired external electrodes can discharge with the same internal electrode, meaning each electrode assembly can form two shock wave generation regions. In the embodiment shown, the two shock wave generation discharge intervals are arranged opposite to each other. Adjacent electrode assemblies can be connected to each other via wires.

[0091] The electrode assembly formed by the paired external electrodes in the above embodiment can be spaced apart along the first length direction, so that the shock wave balloon catheter does not have a long, difficult-to-bend area, thereby increasing the permeability of the shock wave balloon catheter.

[0092] For example, each pair of outer electrodes 200 at least partially overlaps along the length of the shockwave balloon catheter. This allows for a smaller spacing between the emitted shockwaves along the length, thereby enabling more concentrated shockwave therapy to the lesion area and improving treatment efficacy.

[0093] For example, each pair of outer electrodes 200 has the same structure. As a result, each shockwave balloon catheter requires fewer types of parts, resulting in lower production costs and easier assembly.

[0094] The above embodiments can be combined with each other where the features are not contradictory. Specifically, for example, Figure 5 The external electrode 200B of the embodiment shown Figure 7 The external electrode 200D of the illustrated embodiment and Figure 10 The external electrode 200F of the embodiment shown is Figure 3 The external electrodes of the illustrated embodiments are similar, each having a first portion and a second portion, thereby enabling them to be used as follows: Figure 1C As shown, two identical external electrodes are combined to form a pair, and the two external electrodes of the electrode assembly can simultaneously discharge with one internal electrode. In contrast, only one of the external electrodes 200, 200B, 200D, and 200F in the above embodiments... Figure 3 The external electrode 200 shown has a third gap, which allows wires to pass through, unlike the wires in other embodiments.

[0095] For example, a conduit may contain at least two electrode assemblies. Further, on a conduit, the electrode assembly formed by the paired external electrodes described in the above embodiments may also cooperate with other forms of electrode assemblies, which may include the following structure: an inner electrode the same as in the foregoing embodiments, an insulating sleeve the same as in the foregoing embodiments, and an outer electrode with a circumferentially closed structure, wherein the outer electrode is cylindrical and has a discharge edge that cooperates with the inner electrode and the insulating sleeve.

[0096] refer to Figure 14 For example, the insulating sleeve 300 is broken along the circumferential direction of the shockwave balloon conduit, making the insulating sleeve 300 C-shaped and forming a first gap 320 at the break point. Similar to the design of the outer electrode 200, compared to an insulating sleeve 300 without the first gap 320, the C-shaped insulating sleeve 300 allows for a larger gap due to its elasticity, thus facilitating its placement on the inner electrode 100. Optionally, the insulating sleeve 300 can be made of a flexible material, allowing it to be formed not by tubing, but by cutting or stamping sheet-like insulating material. This reduces processing costs. The insulating sleeve 300 can be made of materials including, but not limited to, ceramics, polyimide film, and polytetrafluoroethylene.

[0097] For example, the two disconnected ends of the insulating sleeve 300 are connected by a second elastic portion or tenon structure, which is located within the first gap. This allows the insulating sleeve 300 to be reliably fixed to the outer surface of the inner electrode 100, resulting in higher reliability.

[0098] Alternatively, there can be two insulating sleeves, which can be spaced apart in the circumferential direction, and each insulating sleeve can be provided with a sleeve discharge hole.

[0099] refer to Figure 15 For example, the inner electrode 100 is disconnected along the circumferential direction of the shockwave balloon catheter, making the inner electrode 100 C-shaped and forming a second gap 110 at the disconnection point. The inner electrode 100 can be made of the same conductive material as the outer electrode 200. The C-shaped inner electrode 100 allows for a larger gap due to its elasticity, making it easier to fit over the shockwave balloon catheter. The C-shaped inner electrode 100 can also be made by cutting sheet metal from a sheet material, resulting in higher material utilization.

[0100] For example, the two disconnected ends of the inner electrode 100 are connected by a third elastic part or tenon structure, which is located within the second gap. Thus, the inner electrode 100 can be reliably fixed to the outer surface of the inner tube 20.

[0101] Alternatively, there can be two inner electrodes, which can be spaced apart along the circumferential direction.

[0102] Exemplarily, the second gap 110 at least partially exposes the first gap 320, and the disconnected first end 211 and second end 212 of the external electrode 200 are spaced apart to form a third gap 230, which at least partially exposes the second gap 110. The external electrode 200 and / or the internal electrode 100 are connected to a wire 50, which passes through the first gap 320, the second gap 110, and the third gap 230. As described above, reducing the diameter of the shockwave balloon catheter can improve its permeability for treatment in complex vascular environments. The size of the wire 50 also affects the size of the shockwave balloon catheter in at least one direction. Positioning the wire 50 within the first gap 320, the second gap 110, and the third gap 230 prevents the wire 50 from protruding radially from the surface of the external electrode 200. This results in a more regular shape and better permeability of the shockwave balloon catheter. Exemplarily, the wire 50 of the electrode assembly 10 can be closely abutted against the inner tube 20 to further reduce the outer diameter of the shockwave balloon catheter. When the outer electrode 200 is provided with a first elastic portion 220, resulting in the absence of a third gap 230, and the inner electrode 100 and the insulating sleeve 300 have a first gap 320 and a second gap 110, the wire can pass through the second gap 320 and the first gap 110. Optionally, the wire can also be laid from the outside of the outer electrode 200.

[0103] For example, the inner electrode 100, insulating sleeve 300, and outer electrode 200 of the electrode assembly 10 can be fixed to the inner tube 20 using an adhesive. After the inner electrode 100, insulating sleeve 300, and outer electrode 200 are installed in the inner tube 20, the adhesive ensures that the shock wave will not cause the electrodes to shift. For the sheet-like insulating sleeve 300, the adhesive prevents the edges of the insulating sleeve 300 from lifting off the inner electrode 100. The outer electrode 200 can also be further adhered to the insulating sleeve 300 using an adhesive. As described above, the elasticity of the inner electrode 100 and outer electrode 200 can cooperate with the adhesive, making the electrode assembly 10 more reliably positioned. The adhesive also eliminates the need for an interference fit between the inner tube 20, inner electrode 100, outer electrode 200, and insulating sleeve 300, simplifying the manufacturing process.

[0104] For example, the shockwave balloon catheter may include a plurality of electrode assemblies 10, which may be spaced apart along the length of the inner tube 20. (Return to Reference) Figure 1A , Figure 1A A shockwave balloon catheter with two electrode assemblies 10 is shown. Since each electrode assembly 10 can form up to two discharge gaps, the shockwave can propagate in two directions. By using multiple sets of electrode assemblies 10, the shockwave coverage area can be increased by staggering the external electrode discharge holes 213. Alternatively, the external electrode discharge holes 213 can be aligned so that the shockwaves can overlap at certain locations, achieving a more potent treatment.

[0105] exist Figure 2B In the illustrated embodiment, exemplarily, the discharge edge 2141 of at least one external electrode 200 is offset from the discharge edges 2141 of other external electrodes 200 along the circumferential direction of the shockwave balloon catheter. As described above, one electrode assembly 10 can generate shock waves in two directions. For narrower blood vessels, the angle at which the shock wave can act on the blood vessel may be limited due to the limited diameter of the balloon 40, making it difficult to perform uniform shockwave therapy from all directions. By providing multiple electrode assemblies 10 and oriented the discharge interval 400 of the multiple electrode assemblies 10 in different directions, the shock wave can be transmitted to different angles within the blood vessel without rotating the shockwave balloon catheter, achieving better therapeutic effects. In some specific embodiments, one electrode assembly 10 can generate two opposing cone-shaped shock waves with an arc of 90 degrees, and adjacent electrode assemblies 10 can also generate two opposing cone-shaped shock waves with an arc of 90 degrees. The shock wave axes formed by the two electrodes are perpendicular to each other, thereby achieving 360-degree shockwave therapy. In embodiments not shown, the shock wave propagation angle generated by a single electrode may be smaller, and the shock wave balloon catheter may be equipped with more sets of electrodes to achieve more comprehensive shock wave therapy from more angles.

[0106] For example, in the case where each electrode assembly includes two external electrodes, the lead wires of the shockwave balloon catheter include a first external lead wire, a second external lead wire, and a series lead wire. The first external lead wire is connected to an external electrode of the proximal electrode assembly; the second external lead wire is connected to an external electrode of the distal electrode assembly; series lead wires connect the external electrodes of adjacent electrode assemblies; and each external electrode is connected to only one lead wire. This reduces the number of lead wires and avoids increasing the radial dimension due to a larger number of lead wires. The lead wires can be threaded through gaps in the inner electrode, insulating sleeve, and / or external electrode to avoid increasing the outer diameter of the electrode assembly. If there are no gaps in the inner electrode, insulating sleeve, and external electrode, the lead wires can also be threaded on the outside of the electrode assembly.

[0107] Another aspect of this application provides a shockwave balloon catheter system, including the shockwave balloon catheter of the above embodiment and a main unit, wherein the inner electrode 100 and the outer electrode 200 of the shockwave balloon catheter are electrically connected to the main unit. The main unit can output high-voltage pulses, which are transmitted to the inner electrode 100 and the outer electrode 200 via the wire 50, thereby forming an arc discharge between the inner electrode 100 and the outer electrode 200 and generating a shockwave in the treatment area.

[0108] In the description of this application, it should be understood that the orientation or positional relationship indicated by directional terms such as "front", "back", "up", "down", "left", "right", "horizontal", "vertical", "horizontal", "top", and "bottom" is generally based on the orientation or positional relationship shown in the accompanying drawings and is only for the convenience of describing this application and simplifying the description. Unless otherwise stated, these directional terms do not indicate or imply that the device or element referred to must have a specific orientation or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation on the scope of protection of this utility model; the directional terms "inner" and "outer" refer to the inner and outer contours relative to the outline of each component itself.

[0109] For ease of description, relative terms such as "above," "over," "on the upper surface of," and "above" are used here to describe the regional positional relationship of one or more components or features shown in the figures to other components or features. It should be understood that relative terms include not only the orientation of the component as depicted in the figure but also different orientations during use or operation. For example, if the components in the figures are inverted as a whole, "above" or "above other components or features" will include cases where the component is "below" or "under" other components or features. Thus, the exemplary term "above" can include both "above" and "below." Furthermore, these components or features may also be positioned at other different angles (e.g., rotated 90 degrees or other angles), and this document intends to include all such cases.

[0110] It should be noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the exemplary embodiments according to this application. As used herein, the singular form is intended to include the plural form as well, unless the context clearly indicates otherwise. Furthermore, it should be understood that when the terms "comprising" and / or "including" are used in this specification, they indicate the presence of features, steps, operations, parts, components, and / or combinations thereof.

[0111] It should be noted that the terms "first," "second," etc., in the specification, claims, and accompanying drawings of this application are used to distinguish similar subjects and are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate so that the embodiments of this application described herein can be implemented in sequences other than those illustrated or described herein.

[0112] This application has been described through the above embodiments. However, it should be understood that the above embodiments are for illustrative purposes only and are not intended to limit this application to the scope of the described embodiments. Furthermore, those skilled in the art will understand that this application is not limited to the above embodiments, and many more variations and modifications can be made based on the teachings of this application, all of which fall within the scope of protection claimed by this utility model. The scope of protection of this utility model is defined by the appended claims and their equivalents.

Claims

1. An external electrode for a shockwave balloon catheter, characterized in that, The external electrode includes a body configured to surround at least a portion of the outer periphery of the inner tube of the shockwave balloon catheter in a circumferential direction. The body has a first end and a second end disconnected along the circumferential direction. The curvature of the body is elastically adjustable to change the distance between the first end and the second end. The body includes: A discharge section, configured to surround a portion of the outer periphery of the inner tube of the shockwave balloon catheter along the circumferential direction, and the discharge section having a discharge edge; and The mounting part, one end of which is connected to the discharge part, wherein the center of the discharge part is offset relative to the center of the mounting part in a first length direction along the length of the shock wave balloon catheter.

2. The external electrode as described in claim 1, characterized in that, The discharge section has a first side and a second side opposite to each other along the circumferential direction, wherein: The mounting portion is connected to one of the first side and the second side, and the first end and the second end are respectively located on the other of the first side and the second side, and on the mounting portion; or Both the first side and the second side are connected to the mounting portion, and the first end and the second end are located on different mounting portions.

3. The external electrode as described in claim 2, characterized in that, Oriented toward the first length direction, the connecting portion does not protrude from the discharge portion.

4. The external electrode as described in claim 1, characterized in that, The discharge section has: a first side and a second side opposite to each other along the circumferential direction, and a third side and a fourth side opposite to each other along the length direction of the shock wave balloon catheter, wherein the third side faces the first length direction, wherein: The first side and the fourth side are connected by a circular arc surface transition; and / or The second side and the fourth side are connected by a circular arc surface.

5. The external electrode as described in claim 1, characterized in that, Along the circumferential direction, the size of the discharge section is less than half the circumference of the circle in which the main body is located.

6. The external electrode as described in claim 1, characterized in that, The first end and the second end are connected to each other by a tenon and mortise structure.

7. The external electrode as claimed in claim 1, characterized in that, The external electrode further includes a first elastic portion, which is connected between the first end and the second end.

8. The external electrode as described in claim 7, characterized in that, The first elastic part is in the shape of a bent strip, and the first elastic part is located in the same plane as the main body and is bent towards the length direction of the shock wave balloon catheter.

9. The external electrode as claimed in claim 1, characterized in that, The discharge section has a third side and a fourth side opposite to each other along the length direction of the shock wave balloon catheter, the third side facing the first length direction and the fourth side facing a second length direction opposite to the first length direction. At least a portion of the fourth side forms the discharge edge.

10. The external electrode as claimed in claim 1, characterized in that, An external electrode discharge hole is provided in the middle region of the discharge section. The external electrode discharge hole penetrates the discharge section along the radial direction of the shock wave balloon catheter, and the edge of the external electrode discharge hole forms the discharge edge.

11. An electrode assembly for a shockwave balloon catheter, characterized in that, include: An internal electrode is used to be installed on the inner tube of the shock wave balloon catheter; The outer electrode as claimed in any one of claims 1-10, wherein the outer electrode is disposed outside the inner electrode; and An insulating sleeve is sandwiched between the inner electrode and the outer electrode. The insulating sleeve has a discharge port extending radially along the shockwave balloon catheter, exposing the inner electrode. Wherein: The exposed portion of the inner electrode forms a discharge gap with the discharge edge of the outer electrode.

12. The electrode assembly as claimed in claim 11, characterized in that, The insulating sleeve is broken along the circumferential direction of the shock wave balloon catheter, so that the insulating sleeve is C-shaped and a first gap is formed at the break point of the insulating sleeve.

13. The electrode assembly as claimed in claim 12, characterized in that, The two ends of the disconnected insulating sleeve are connected by a second elastic part or a tenon structure, which is located within the first gap.

14. The electrode assembly as claimed in claim 12, characterized in that, The inner electrode is disconnected along the circumferential direction of the shock wave balloon catheter, so that the inner electrode is C-shaped and a second gap is formed at the disconnection point of the inner electrode.

15. The electrode assembly as claimed in claim 14, characterized in that, The two ends of the disconnected inner electrode are connected by a third elastic part or tenon structure, which is located within the second gap.

16. The electrode assembly as claimed in claim 14, characterized in that, The second gap at least partially exposes the first gap. The disconnected first and second ends of the external electrode are spaced apart to form a third gap, the third gap at least partially exposing the second gap. The outer electrode and / or the inner electrode are connected to wires, which pass through the first gap, the second gap and the third gap.

17. The electrode assembly as claimed in claim 11, characterized in that, The electrode assembly includes two external electrodes arranged along the length of the shockwave balloon catheter. The mounting portions of the two external electrodes are offset in opposite directions relative to their respective discharge points, such that the distance between the mounting portions of the two external electrodes is greater than the distance between the discharge portions of the two external electrodes.

18. The electrode assembly as claimed in claim 11, characterized in that, The electrode assembly includes n external electrodes spaced apart and n-1 internal electrodes spaced apart, where n is an integer greater than or equal to 2. Each external electrode and its adjacent external electrode form the discharge interval with the same internal electrode. The outer electrode, corresponding to only one inner electrode, is connected to a wire.

19. The electrode assembly as claimed in claim 11, characterized in that, The electrode assembly includes n-1 external electrodes spaced apart and n internal electrodes spaced apart, where n is an integer greater than or equal to 2. Each inner electrode and its adjacent inner electrode form the discharge interval with the same outer electrode. The inner electrode, which corresponds to only one outer electrode, is connected to a wire.

20. The electrode assembly as described in any one of claims 17-19, characterized in that, The number of insulating sleeves is one, and the insulating sleeve is provided with sleeve discharge holes that are the same as the total number of external electrodes and are provided one-to-one.

21. The electrode assembly as described in any one of claims 17-19, characterized in that, The discharge edge of at least one external electrode is offset from the discharge edges of the other external electrodes along the circumferential direction of the shock wave balloon catheter.

22. The electrode assembly as claimed in claim 11, characterized in that, When the external electrode includes the external electrode discharge hole, the sleeve discharge hole is aligned with the center of the external electrode discharge hole.

23. A shockwave balloon catheter, characterized in that, include: Inner tube, the lumen of which is used for the guide wire to pass through; An outer tube, which is sleeved on the inner tube and spaced apart from the inner tube; A balloon, which is fitted onto and spaced apart from the inner tube, and is connected to the outer tube; as well as The electrode assembly as described in any one of claims 11-22 is disposed within the space between the balloon and the inner tube, wherein the inner electrode of the electrode assembly is disposed on the inner tube.

24. The shockwave balloon catheter as described in claim 23, characterized in that, The wires of the electrode assembly are in close contact with the inner tube.

25. The shockwave balloon catheter as described in claim 23, characterized in that, The inner electrode, the insulating sleeve, and the outer electrode of the electrode assembly are fixed to the inner tube by adhesive.

26. The shockwave balloon catheter as described in claim 23, characterized in that, The shockwave balloon catheter includes a plurality of electrode assemblies, which are spaced apart along the length of the inner tube.

27. The shockwave balloon catheter as described in claim 26, characterized in that, In the case where each of the electrode assemblies includes two external electrodes, the lead wires of the shockwave balloon catheter include a first external lead wire, a second external lead wire, and a series lead wire. The first external lead wire is connected to an external electrode of the proximal electrode assembly; The second external wire is connected to an external electrode of the remote electrode assembly; The series wires connect the outer electrodes of adjacent electrode assemblies; and Each external electrode is connected to only one wire.

28. A shockwave balloon catheter system, characterized in that, include: Shockwave balloon catheter as described in any one of claims 23-27; as well as The host unit, wherein the inner electrode and the outer electrode of the shockwave balloon catheter are electrically connected to the host unit.

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