Shockwave balloon catheter and method of manufacturing the same

Abstract

The application discloses a shock wave balloon catheter and a manufacturing method thereof, and relates to the technical field of medical devices, which comprises a balloon, an electrode assembly and a lead wire, the balloon can be filled with a conductive solution, the inner tube is a hollow tubular structure, and the distal end of the inner tube can extend into the balloon, the electrode assembly comprises a positioning sleeve, a protective sleeve, an intermediate electrode and a lead wire electrode, the positioning sleeve and the protective sleeve are coaxially sleeved on the inner tube from inside to outside, the intermediate electrode and the lead wire electrode are respectively embedded in the positioning sleeve, the protective sleeve is provided with an excitation through hole for exposing at least part of the intermediate electrode and at least part of the lead wire electrode, so that the intermediate electrode and the lead wire electrode form an electrode pair, and at least one end of the lead wire is embedded in the positioning sleeve and connected with the lead wire electrode and guarantees smooth transition of the profile of each part of the protective sleeve. In this way, the overall outer diameter of the system electrode assembly is reduced, the strength of the connection between the intermediate electrode, the lead wire electrode and the lead wire is improved, and the stability of the electrode assembly is improved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a shockwave balloon catheter and its manufacturing method. Background Technology

[0002] Vascular calcification is a common vascular disease, pathologically characterized by the accumulation of plaques composed of fibrous, fatty, and calcium salts within blood vessels. This leads to narrowing and hardening of the vessels, obstructing blood flow and reducing oxygen and energy supply to bodily organs. Peripheral vascular calcification easily causes arteriosclerosis of the lower extremities, initially presenting with symptoms such as coldness, numbness, and claudication in the lower limbs. In severe cases, weakened dorsalis pedis artery pulsation may even necessitate amputation. Currently, minimally invasive interventional surgery is the main treatment for vascular calcification lesions. While techniques such as high-pressure balloons, chocolate balloons, and plaque ablation are commonly used, they have significant drawbacks. These methods not only carry a high risk of complications, such as vascular perforation, dissection, and embolism, but are also ineffective for deep or eccentric calcification lesions, making it difficult to completely remove the diseased tissue.

[0003] New endovascular treatment technologies have emerged, which draw on the principle of extracorporeal shock wave lithotripsy. A balloon catheter is delivered to the lesion site, and the electrode inside the balloon generates a hydroelectric shock wave under high voltage. Through the cavitation effect, the shock wave passes through the balloon and acts on the calcified area, thereby breaking up the calcified material, restoring the elasticity and remodeling of blood vessels, and reducing damage to the inner wall of blood vessels.

[0004] However, traditional shockwave balloon electrode designs have shortcomings. The method of laterally welding the electrode pads to the leads and overlapping the inner and outer electrodes with the insulation layer results in an excessively large outer diameter of the finished electrode, increasing the difficulty of balloon folding and obstructing passage through narrow blood vessels. Furthermore, the linear contact between the leads and the curved surface leads to low tensile strength, making them prone to instability such as lead detachment during surgical procedures, affecting treatment efficacy and safety. In addition, controlling the directionality of shockwave generation during electrode assembly typically relies on complex structures or tooling, which is not very convenient.

[0005] Therefore, how to effectively reduce its outer diameter, improve assembly directionality, and ensure that the balloon can obtain a smaller outer diameter after folding, thereby significantly improving the balloon's ability to pass through narrowed blood vessels and providing more convenient conditions for surgical operations, is a technical problem that needs to be solved by those skilled in the art. Summary of the Invention

[0006] The purpose of this invention is to provide a shockwave balloon catheter that can effectively reduce its outer diameter, ensuring that the balloon can obtain a smaller outer diameter after folding, thereby significantly improving the balloon's ability to pass through narrowed blood vessels, providing more convenient conditions for surgical operations, and also improving the stability of the electrode assembly.

[0007] To achieve the above objectives, the present invention provides the following technical solution:

[0008] A shockwave balloon catheter, comprising:

[0009] A balloon that can be filled with a conductive solution;

[0010] The inner tube is a hollow tubular structure, with its distal end extending into the balloon.

[0011] An electrode assembly includes a positioning sleeve, a protective sleeve, an intermediate electrode, and a lead electrode. The positioning sleeve and the protective sleeve are coaxially sleeved on the inner tube from the inside to the outside. The intermediate electrode and the lead electrode are respectively embedded in the positioning sleeve. The protective sleeve is provided with an excitation through hole for exposing at least part of the intermediate electrode and at least part of the lead electrode, so that the intermediate electrode and the lead electrode form an electrode pair.

[0012] A wire, at least one end of which is embedded in the positioning sleeve and connected to the wire electrode, forms an assembly with the wire and the wire electrode connected together. The maximum radial height of the assembly does not exceed the outer circumferential surface of the positioning sleeve, thereby giving the protective sleeve fitted over the assembly a smooth cylindrical structure. In one possible embodiment, the wire electrode is provided with a notch, and the positioning sleeve is provided with a notch, with one end of the wire extending into the notch and embedded in the notch.

[0013] In one possible implementation, at least two sets of electrode assemblies are included. The wires include bridging wires and electrode wires. Each electrode assembly is connected in series through bridging wires. The entire electrode assembly is connected to an excitation source through electrode wires. Each electrode assembly includes a positioning sleeve, a protective sleeve, an intermediate electrode, and two wire electrodes. The excitation through holes opened in the protective sleeves of each electrode assembly have different orientations.

[0014] In one possible implementation, two sets of electrode assemblies are included: a distal electrode assembly and a proximal electrode assembly.

[0015] The two lead electrodes of the distal electrode assembly are respectively connected to a bridging lead and an electrode lead, and both lead electrodes of the distal electrode assembly have notches facing the proximal end.

[0016] The lead electrode of the proximal electrode assembly for connecting the bridging lead has a notch or groove facing the distal end, and the lead electrode of the proximal electrode assembly for connecting the electrode lead has a notch or groove facing the proximal end or the distal end.

[0017] In one possible implementation, the electrode assembly includes a distal electrode assembly, which includes at least two electrode pairs formed by an intermediate electrode and two wire electrodes.

[0018] The intermediate electrode and the two lead electrodes are arranged in a row along the axial direction of the positioning sleeve, with the intermediate electrode located between the two lead electrodes, or...

[0019] The intermediate electrode and the two wire electrodes are offset from each other along the axial direction of the positioning sleeve, and the two wire electrodes are located on the same side or on both sides of the intermediate electrode.

[0020] In one possible implementation, the electrode assembly includes a proximal electrode assembly, which includes at least two electrode pairs formed by an intermediate electrode and two wire electrodes.

[0021] The positioning sleeve of the proximal electrode assembly is a non-closed annular part with several through slots extending axially, through slots for the electrode wires to be embedded through.

[0022] The intermediate electrode and the two lead electrodes are arranged in a row along the axial direction of the positioning sleeve, and the width of the through groove is not less than the width of one electrode lead, or...

[0023] The intermediate electrode and the two lead electrodes are offset axially from each other in the positioning sleeve. Both lead electrodes are located on the same side of the intermediate electrode. The total width of the through groove is not less than the sum of the widths of the two electrode lead electrodes, or...

[0024] The intermediate electrode and the two lead electrodes are staggered in the axial direction of the positioning sleeve. The two lead electrodes are located on both sides of the intermediate electrode, and the width of the through groove is not less than the width of one lead electrode.

[0025] In one possible implementation, the inner tube has at least a plurality of arc segments and a plurality of platform segments alternately distributed circumferentially at its distal end. The intermediate electrode is arc-shaped and spans at least one platform segment and two arc segments adjacent to the platform segment. The gap between the intermediate electrode and the platform segment it spans is used to accommodate adhesive. The wire electrode is at least connected to the platform segment. The gap between the protective sleeve and the platform segment is used to accommodate the wire and / or adhesive.

[0026] In one possible implementation, at least two sets of electrode assemblies are included, each set of electrode assemblies including a positioning sleeve, a protective sleeve, an intermediate electrode and two lead electrodes, and the excitation through holes of the protective sleeves of each electrode assembly are staggered from each other.

[0027] in,

[0028] The intermediate electrode and two lead electrodes are arranged in a row along the axial direction of the positioning sleeve. The platform section provides a positioning reference for the lead electrodes, and the gap between the lead electrodes and the intermediate electrode is located in the arc section and exposed by the excitation through-hole; or,

[0029] The intermediate electrode and the two lead electrodes are offset in the axial direction of the positioning sleeve. The two platform sections provide positioning references for the lead electrodes and the intermediate electrode. The gap between the lead electrodes and the intermediate electrode is located in the platform section and is exposed by the excitation through hole.

[0030] In one possible implementation, the intermediate electrode is partially surrounded by the inner tube, and the inner wall of the intermediate electrode includes alternating arc-shaped segments and deformable segments, the deformable segments being straight or wavy; and / or, the inner tube is provided with a first concave surface for embedding a wire.

[0031] In one possible implementation, the two positioning sleeves are integrated into a single structure via a flexible connector.

[0032] This application also provides a method for manufacturing a shockwave balloon catheter, applicable to the aforementioned shockwave balloon catheter, comprising the following steps: providing a positioning sleeve; forming a positioning hole for an intermediate electrode, a positioning hole for a lead electrode, and a notch by laser cutting, the notch communicating with the positioning hole for the lead electrode; forming a notch groove on the lead electrode by laser cutting; embedding the intermediate electrode and the lead electrode into the positioning hole for the intermediate electrode and the positioning hole for the lead electrode, respectively; placing the end of the lead electrode through the notch into the notch groove of the lead electrode and welding it in place; and fitting a protective sleeve around the outer periphery of the positioning sleeve, aligning the excitation through-hole with the gap between the intermediate electrode and the lead electrode to obtain an electrode pair composed of the intermediate electrode and the lead electrode. Compared with the above-mentioned background technology, the shockwave balloon catheter provided by this invention has at least the following beneficial effects:

[0033] The present invention has an intermediate electrode and a wire electrode embedded in a positioning sleeve, and a wire is embedded in the positioning sleeve and connected to the wire electrode. At the same time, through the interlocking of the inner tube, the positioning sleeve and the protective sleeve, the intermediate electrode, the wire electrode and the wire are clamped by the inner tube and the protective sleeve, which can also prevent their connection from loosening and falling off, thus ensuring the stability of the electrode assembly.

[0034] In other words, this inlay connection method avoids the problem of accumulated outer diameter caused by traditional overlapping structures, making the various parts of the electrode assembly tightly integrated and rationally distributed. It can control the final electrode assembly thickness to a level close to the wall thickness of the positioning sleeve and the protective sleeve, thereby significantly reducing the total outer diameter of the system electrode assembly. With a fixed balloon thickness, it effectively reduces the outer diameter of the balloon after folding, greatly enhancing the balloon's ability to pass through the stenotic vascular lesion, and significantly improving the operability and success rate of the surgery. Moreover, this connection method also improves the strength of the intermediate electrode, lead electrode, and lead connection, and improves the stability of the electrode assembly. Attached Figure Description

[0035] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the provided drawings without creative effort.

[0036] Figure 1 This is a schematic diagram of the electrode assembly and inner tube structure provided in an embodiment of the present invention;

[0037] Figure 2 for Figure 1 Cross-sectional view at point AA;

[0038] Figure 3 for Figure 1 Cross-sectional view at BB;

[0039] Figure 4 for Figure 1 A slanted view of the two protective sleeves on the hidden surface;

[0040] Figure 5 for Figure 4 Remove the oblique view of the inner tube;

[0041] Figure 6 This is a circuit diagram of the electrode assembly provided in an embodiment of the present invention;

[0042] Figure 7 A schematic diagram of an embodiment where the wire electrodes provided by the present invention are located on both sides of the intermediate electrode;

[0043] Figure 8 This is a schematic diagram of a structure provided in an embodiment of the present invention, in which the wire electrode and intermediate electrode are arranged together and the positioning sleeve and protective sleeve are hidden.

[0044] Figure 9 for Figure 8 Cross-sectional view at CC;

[0045] Figure 10 for Figure 8 Cross-sectional view at DD;

[0046] Figure 11 This is a schematic diagram of the connection structure between the wire electrode and the wire provided in an embodiment of the present invention;

[0047] Figure 12 This is a schematic diagram of the intermediate electrode structure provided in an embodiment of the present invention;

[0048] Figure 13 This is a schematic diagram of the inner tube provided in an embodiment of the present invention;

[0049] Figure 14 for Figure 13 The inner tube cross-section diagram;

[0050] Figure 15 This is a schematic diagram of another embodiment of the wire electrode provided by the present invention;

[0051] Figure 16Schematic structural diagram of another embodiment of the intermediate electrode provided by the present invention;

[0052] Figure 17 is Figure 16 Schematic structural diagram from another perspective;

[0053] Figure 18 Cross-sectional view of the structure of another embodiment provided by the present invention;

[0054] Figure 19 Schematic structural diagram of another embodiment of the wire electrode provided by the present invention;

[0055] Figure 20 Schematic structural diagram of another embodiment of the intermediate electrode provided by the present invention;

[0056] Figure 21 Schematic structural diagram of the positioning sleeve provided by the embodiment of the present invention;

[0057] Figure 22 Another schematic structural diagram of the positioning sleeve provided by the embodiment of the present invention;

[0058] Figure 23 Schematic structural diagram of the integrated positioning sleeve provided by the embodiment of the present invention;

[0059] Figure 24 Schematic structural diagram of an embodiment of the inner tube provided by the present invention;

[0060] Figure 25 Overall schematic diagram of another embodiment structure of the present invention;

[0061] Figure 26 Schematic structural diagram of an embodiment of the positioning sleeve provided by the present invention;

[0062] Figure 27 is Figure 26 Schematic structural diagram from another angle of;

[0063] Figure 28 The present invention provides a Figure 26 Schematic structural diagram of the protective sleeve配套 with the positioning sleeve in.

[0064] Where:

[0065] 100 - inner tube, 110 - outer plane, 120 - first inner concave surface, 130 - second inner concave surface;

[0066] 200 - distal electrode assembly;

[0067] 300 - proximal electrode assembly;

[0068] 410-Positioning sleeve, 411-Through groove, 412-Notch, 420-Protective sleeve, 421-Excitation through hole, 430-Intermediate electrode, 431-Intermediate electrode positioning hole, 440-Wire electrode, 441-Wire electrode positioning hole, 442-Notch groove, 450-Electrode wire, 460-Bridging wire, 470-Flexible connector, 480-Inner plane, 481-Groove. Detailed Implementation

[0069] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0070] To enable those skilled in the art to better understand the present invention, the invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. In the specific embodiments, the distal end refers to the part of the corresponding component that is farther from the operator, typically the end where the component enters the patient's body or surgical area. The proximal end is the part of the corresponding component that is closer to the operator, typically the end held or manipulated by the operator. For a single component, the end closer to the operator is the proximal end, and the end farther from the operator is the distal end. Furthermore, it should be noted that the connections mentioned in this application include both direct connections between systems, components, and parts, and indirect connections between systems, components, and parts via a medium. Those skilled in the art should not interpret this as a limitation but should adapt it according to specific needs; all such connections do not exceed the scope of protection of this application.

[0071] The purpose of this invention is to provide a shockwave balloon catheter that can effectively reduce its outer diameter, ensuring that the balloon can obtain a smaller outer diameter after folding, thereby significantly improving the balloon's ability to pass through narrowed blood vessels, providing more convenient conditions for surgical operations, and also improving the stability of the electrode assembly.

[0072] To achieve the above objectives, the present invention provides the following technical solution:

[0073] Please see Figures 1 to 10This embodiment provides a shockwave balloon catheter, including: a balloon, an electrode assembly, and leads. The interior of the balloon can be filled with a conductive solution; the inner tube 100 is a hollow tubular structure, the distal end of which can extend into the interior of the balloon; the material of the inner tube 100 is preferably a polymer material, which can be single-layered or multi-layered. When the inner tube 100 is multi-layered, the inner layer is generally a lubricating material such as PE (Polyethylene) or PTFE (Polytetrafluoroethylene), while the outer layer is a rigid polymer material providing support. When the strength is insufficient, a braided layer can also be added to the inner tube 100 to increase its overall strength.

[0074] The electrode assembly includes a positioning sleeve 410, a protective sleeve 420, an intermediate electrode 430, and a lead electrode 440. The positioning sleeve 410 and the protective sleeve 420 are coaxially sleeved on the inner tube 100 from the inside to the outside. Figure 21 , 22 As shown, the positioning sleeve 410 is provided with an intermediate electrode positioning hole / groove 431 and a wire electrode positioning hole / groove 441. The intermediate electrode 430 and the wire electrode 440 are respectively embedded in the corresponding holes / grooves in the positioning sleeve 410, as shown. Figure 4 , 5 As shown, a strong connection is achieved using adhesive techniques (such as super glue, UV glue, or epoxy glue).

[0075] In this embodiment, the lead electrode 440 and the intermediate electrode 430 are made of conductive materials, which can be the same material or different materials, generally 304V stainless steel, 304 stainless steel or platinum-iridium alloy.

[0076] To improve the overall dimensional consistency of the electrode assembly and the smoothness of the catheter delivery, the present application also incorporates a lead wire embedded in the positioning sleeve 410. The lead wire is connected to the lead electrode 440, forming an assembly. The maximum radial height of the assembly does not exceed the outer circumferential surface of the positioning sleeve 410, resulting in a smooth cylindrical structure for the protective sleeve 420 fitted over the assembly. This prevents bulges in the protective sleeve 420 caused by the lead wire and lead electrode 440, achieving both a reduction in the overall wall thickness of the electrode assembly and a smooth overall contour. The commensurate human body cavity is smaller than that of existing catheters, significantly enhancing the catheter's ability to pass through narrowed vascular lesions.

[0077] In this embodiment, the lead wire is preferably enameled wire, and its outer diameter is larger than the wall thickness of the lead wire electrode 440. The electrode wall thickness is not greater than the wall thickness of the positioning sleeve 410. Thus, the outer diameter of the entire electrode assembly is the outer diameter of the protective sleeve 420. The outer diameter a of the protective sleeve 420 = outer diameter of the inner tube 100 + outer diameter of the lead wire × 2 + wall thickness of the protective sleeve 420 × 2. The outer diameter b of the existing shockwave balloon electrode assembly = outer diameter of the inner tube 100 + outer diameter of the lead wire × 2 + wall thickness of the protective sleeve 420 × 2. The outer diameter of the entire electrode assembly in this application is significantly smaller than the outer diameter of the existing shockwave balloon electrode assembly. When the outer diameter of the electrode assembly is reduced, the entire shockwave balloon catheter can more easily pass through the stenotic lesion.

[0078] The positioning sleeve 410 is a round tube and is generally made of materials such as PI (polyimide), PEEK (polyether ether ketone), PEBAX (polyether block polyamide), and TPU (thermoplastic polyurethane elastomer). Since the positioning hole / groove 431 of the intermediate electrode and the positioning hole / groove 441 of the wire electrode are not in direct contact, the positioning sleeve 410 also serves as an insulating part between the intermediate electrode 430 and the wire electrode 440.

[0079] The protective sleeve 420 is also a cylindrical structure, which is sleeved on the outer periphery of the positioning sleeve 410. However, it is provided with an excitation through hole 421 for exposing at least part of the intermediate electrode 430 and at least part of the lead electrode 440, so that the intermediate electrode 430 and the lead electrode 440 form an electrode pair. That is, when the balloon is filled with conductive solution, the conductive solution will directly contact the lead electrode 440 and the intermediate electrode 430 through the excitation through hole 421 of the protective sleeve 420. The lead electrode 440 and the intermediate electrode 430 are connected to each other through the conductive solution. At this time, the insulation function of the positioning sleeve 410 fails, and an excitation point is formed in the excitation through hole 421 of the protective sleeve 420 and a cavitation effect is generated. The explosive impact force of the cavitation effect is excited radially outward through the excitation through hole 421, thereby generating an impact force on the plaque in the blood vessel and causing the plaque to break.

[0080] The present invention has an intermediate electrode 430 and a wire electrode 440 embedded in the positioning sleeve 410, and a wire is embedded in the positioning sleeve 410 and connected to the wire electrode 440. At the same time, through the interlocking of the inner tube 100, the positioning sleeve 410 and the protective sleeve 420, the intermediate electrode 430, the wire electrode 440 and the wire are clamped by the inner tube 100 and the protective sleeve 420, thereby preventing their connection from loosening and falling off, and ensuring the stability of the electrode assembly.

[0081] This inlay connection method avoids the problem of accumulated outer diameter caused by traditional overlapping structures, making the various parts of the electrode assembly tightly integrated and rationally distributed. It can control the final electrode assembly thickness to a level close to the wall thickness of the lead electrode 440 or the positioning sleeve 410, thereby significantly reducing the total outer diameter of the system electrode assembly. With a fixed balloon thickness, it effectively reduces the outer diameter of the balloon after folding, greatly enhancing the balloon's ability to pass through the stenotic vascular lesion, and significantly improving the operability and success rate of the surgery. Moreover, this connection method also improves the strength of the intermediate electrode 430, the lead electrode 440, and the lead connection, thus improving the stability of the electrode assembly.

[0082] In one possible implementation, the wire electrode 440 is provided with a notch 442, and the positioning sleeve 410 is provided with a notch 412, with one end of the wire extending into the notch 412 and embedded in the notch 442.

[0083] Specifically, such as Figure 7 , Figure 11 , Figure 15 , Figure 19 As shown, the notch 442 on the wall of the lead electrode 440 provides a stable structural foundation for lead connection. When connecting the lead to the lead electrode 440, the end of the lead is inserted into the notch 442. Preferably, the lead is fixed to the notch 442 by welding or pressing, ensuring that the wall thickness at the connection is consistent with the wall thickness of the lead electrode 440. This connection method increases the contact area between the lead electrode 440 and the lead, effectively dispersing the stress during external pulling. Compared with the traditional linear contact connection method, it significantly improves the tensile strength of the connection. During surgery, even under the influence of external forces generated by the complex hemodynamic environment within the blood vessels, the lead can be firmly connected to the lead electrode 440, ensuring the integrity and functional stability of the electrode assembly and providing reliable protection for the normal operation of the shockwave balloon.

[0084] Furthermore, to enable the wire to connect to the wire electrode 440 without increasing the overall thickness of the electrode assembly, the positioning sleeve 410 has an opening 412 at the end of the notch 442 of the wire electrode 440 for the wire to pass through. This connection method ensures that the thickness of the wire coincides with the thickness of the positioning sleeve 410, thus preventing an increase in the overall outer diameter of the electrode assembly due to the connection of the wire. Simultaneously, it increases the contact area between the wire and the positioning sleeve 210, optimizing the ease and robustness of assembly.

[0085] In one possible implementation, the shockwave balloon catheter includes at least two sets of electrode assemblies, specifically as follows: Figure 1 , Figure 4 , Figure 5 , Figure 7 , Figure 8 , Figure 23 , Figure 25 As shown; the conductors include bridging conductors 460 and electrode conductors 450. Each electrode assembly is connected in series through bridging conductors 460. The entire electrode assembly is connected to the excitation source through electrode conductors 450. Each electrode assembly includes the positioning sleeve 410, protective sleeve 420, intermediate electrode 430 and two conductor electrodes 440 mentioned above. The excitation through holes 421 opened in the protective sleeves 420 of each electrode assembly have different orientations, that is, the shock wave excitation point is located in different circumferential orientations of the conduit.

[0086] When there are more than two sets of electrode assemblies, one of the two lead electrodes 440 in the electrode assemblies at both ends is connected to the excitation source through the electrode lead 450, and the other lead electrode 440 is connected to one lead electrode 440 in the middle electrode assembly through the bridging lead 460. The other lead electrode 440 of the electrode assembly is connected to the lead electrode 440 of the next set of electrode assemblies through the bridging lead 460. This cycle continues until all electrode assemblies are connected in series through the bridging lead 460. In this way, the conductive solution in the excitation through hole on the protective sleeve 420 forms an excitation point, which can form a complete circuit together with the excitation source.

[0087] Moreover, by staggering the excitation through holes 421 on each group of electrode components, multi-directional vibrations can be generated on the vascular lesions to form a near-uniform vibration, thereby creating a more uniform effect on the vascular lesions and making it easier to break up the plaque.

[0088] Furthermore, the embodiments provided herein include two sets of electrode assemblies, namely a distal electrode assembly 200 and a proximal electrode assembly 300.

[0089] Specifically, such as Figure 1 , Figure 4 , Figure 5 , Figure 7 , Figure 8 , Figure 23 , Figure 25As shown, the two lead electrodes 440 of the distal electrode assembly 200 are respectively connected to a bridging lead 460 and an electrode lead 450. One of the two lead electrodes 440 of the proximal electrode assembly 300 is connected to the other end of the bridging lead 460, and the other is connected to the excitation source through another electrode lead 450. It should be noted that, in order to facilitate the connection of the bridging lead 460, reduce the winding length of the bridging lead 460, and avoid increasing the total outer diameter of the entire electrode assembly due to the connection of the bridging lead 460, this embodiment will use... The notch 442 of the two wire electrodes 440 connecting the bridging wire 460 are arranged opposite to each other. Specifically, both wire electrodes 440 of the distal electrode assembly 200 have notches 442 facing the proximal end, while the wire electrodes 440 of the proximal electrode assembly 300 used to connect the bridging wire 460 have notches 442 facing the distal end, and the wire electrodes 440 of the proximal electrode assembly 300 used to connect the electrode wire 450 can be selected to have notches 442 facing the proximal end or the distal end according to the actual situation.

[0090] Furthermore, in this embodiment, the protective sleeve 420 of both the distal electrode assembly 200 and the proximal electrode assembly 300 is provided with two excitation through holes 421 to correspond to the two lead electrodes 440. The two excitation through holes 421 are distributed at a 180° interval, which can form an approximately uniform vibration in the 360° direction, thereby creating a more uniform effect on intravascular lesions and improving the treatment effect.

[0091] Based on the above embodiments, the electrode assembly includes a distal electrode assembly 200, which includes at least two electrode pairs formed by an intermediate electrode 430 and two lead electrode 440; it should be noted that the intermediate electrode 430 and the two lead electrode 440 are arranged together in the axial direction of the positioning sleeve 410, such as Figure 8 , 9 As shown in Figure 10, the intermediate electrode 430 is located between the two wire electrodes 440, or the intermediate electrode 430 and the two wire electrodes 440 are offset from each other in the axial direction of the positioning sleeve 410. The offset arrangement includes the two wire electrodes 440 being located on the same side of the intermediate electrode 430 (e.g., ...). Figure 5 , 21 (as shown in Figure 22) or both sides (as shown in Figure 22) Figure 7 The arrangement shown is as shown.

[0092] In other words, the intermediate electrode 430 and the two lead electrodes 440 of the distal electrode assembly 200 can be arranged in a row along the axial direction of the positioning sleeve 410, that is, the intermediate electrode 430 and the two lead electrodes 440 are distributed on a circumference of the positioning sleeve 410. It should be noted that the arrangement here does not require that the two have the same size in the axial direction of the conduit, but rather that they overlap in the axial position of the conduit, and the excitation through hole 421 corresponds to the position where the two overlap in the axial direction, that is, the excitation point at the excitation through hole 421 is circumferentially connected between the intermediate electrode 430 and the lead electrodes 440; the intermediate electrode 430 and the two lead electrodes 440 can also be staggered in the axial direction of the positioning sleeve 410. The staggered arrangement includes the two lead electrodes 440 being located on both sides of the middle or on the same side of the intermediate electrode 430. It should be noted that the staggered arrangement here is limited to the axial direction of the positioning sleeve 410. Projecting the intermediate electrode 430 and the lead electrodes 440 along the axial direction, it can be seen that they overlap in the circumferential direction, such as Figure 4 , Figure 5 , Figure 7 As shown, the intermediate electrode 430 and the lead electrode 440 overlap circumferentially, meaning the excitation point at the excitation through-hole 421 is axially connected between the intermediate electrode 430 and the lead electrode 440. In simpler terms, taking the circumferential extension of the intermediate electrode 430 and the two lead electrodes 440 as their length, and the axial extension of the intermediate electrode 430 and the two lead electrodes 440 as their width, in an arrangement where the intermediate electrode 430 and the lead electrode 440 are arranged side-by-side, the excitation point is located at the gap between the intermediate electrode 430 and the two lead electrodes 440 along their length. In an arrangement where the intermediate electrode 430 and the lead electrode 440 are axially staggered, the excitation point is located at the gap between the intermediate electrode 430 and the two lead electrodes 440 along their width.

[0093] Specifically, the distribution of the intermediate electrode 430 and the two lead electrodes 440 in the distal electrode assembly 200 is divided into three types. The first distribution method is as follows: Figure 5 As shown, the two lead electrodes 440 are distributed on the same side of the intermediate electrode 430, and to facilitate the connection of the bridging lead 460, the lead electrodes 440 in the distal electrode assembly 200 are distributed inside the intermediate electrode 430, that is, on the side closer to the proximal electrode assembly 300; the second distribution method is similar. Figure 7 As shown in the right-hand electrode assembly, the two lead electrodes 440 in the distal electrode assembly 200 are distributed on both sides of the intermediate electrode 430. The arrangement of the lead electrodes 440 on both sides of the intermediate electrode 430 causes an increase in the axial dimension of the electrode assembly, while the difference in flexibility across different parts of the electrode assembly is relatively small. The third distribution method is specifically as follows... Figure 8 , Figure 9 and Figure 10The intermediate electrode 430 and the two lead electrodes 440 of the distal electrode assembly 200 are distributed on a circumference of the positioning sleeve 410, that is, the intermediate electrode 430 and the lead electrodes 440 can be arranged in parallel. In this embodiment, the two excitation through holes 421 can be spaced 90° apart circumferentially. Because of space constraints, the size of some electrodes needs to be reduced, which is not conducive to part processing and semi-finished product assembly, and also affects the electrode discharge parameters. In this way, the intermediate electrode 430 and the two lead electrodes 440 are concentrated in one axial region, resulting in a compact and reasonable layout in this region. However, the concentration in one axial region also results in a higher hardness of the electrode assembly in this region, which may affect the push compliance of the conduit. The above three methods each have their advantages and can be selected according to specific needs in specific embodiments, all of which are within the protection scope of this application.

[0094] In one possible implementation, the electrode assembly includes a proximal electrode assembly 300, which includes at least two electrode pairs formed by an intermediate electrode 430 and two lead electrodes 440. The positioning sleeve 410 of the proximal electrode assembly 300 is a non-closed annular member having a plurality of axially extending through grooves 411, such as... Figure 22 The through groove 411 allows the electrode wire to be embedded. It is understood that the through groove 411 facilitates the routing of the wire. After the wire is connected, it can be directly inserted into the through groove 411. In this way, the wire will be clamped in the space between the inner tube 100 and the protective sleeve 420. Its diameter will coincide with the thickness of the positioning sleeve 410, thereby avoiding pressing the wire under the wire electrode 440 and causing the outer diameter of the electrode assembly to increase. At the same time, it will be firmly fixed to the outer surface of the inner tube 100 under the pressure of the protective sleeve 420.

[0095] Based on the above embodiments, an optional embodiment is that the intermediate electrode 430 and two lead electrode 440 of the proximal electrode assembly 300 are arranged in a row along the axial direction of the positioning sleeve 410, and the width of the through groove 411 is not less than the width of one electrode lead 450, specifically as follows. Figure 8 , Figure 9 As shown, one of the lead electrodes 440 of the distal electrode assembly 200 is connected to a connecting wire 450, and the connecting wire 450 will pass directly through the through groove 411, that is, the through groove 411 is formed in... Figure 9 The connecting wire 450 is located at the position (positioning sleeve 410 not shown), and its width matches that of the connecting wire 450.

[0096] Based on the above embodiments, an optional embodiment is that the intermediate electrode 430 and the two lead electrodes 440 of the proximal electrode assembly 300 are staggered in the axial direction of the positioning sleeve 410, and the two lead electrodes 440 are both located on the same side of the intermediate electrode 430. The total width of the through groove 411 is not less than the sum of the widths of the two electrode leads 450, as specifically... Figure 5 As shown, the through groove 411 allows not only the connecting wires connected to the wire electrode 440 in the distal electrode assembly 200 to pass through, but also the connecting wires connected to the wire electrode 440 in the proximal electrode assembly 300 to pass through. Therefore, the width of the through groove 411 in this embodiment should not be less than the sum of the widths of the two wires, so that the two connecting wires are laid flat in the through groove 411 to avoid the cumulative effect on the radial dimensions. Of course, in this embodiment, two through grooves 411 can also be provided on the positioning sleeve 410, each through groove 411 of width can allow one wire to pass through, but preferably one through groove 411 with a width not less than the sum of the widths of the two wires, so as to better ensure that the positioning sleeve 410 has a better clamping and gripping shape of the inner tube 100.

[0097] Based on the above embodiments, an optional embodiment is that the intermediate electrode 430 and the two lead electrodes 440 of the proximal electrode assembly 300 are staggered axially in the positioning sleeve 410, with both lead electrodes 440 located on both sides of the intermediate electrode 430, and the width of the through groove 411 is not less than the width of one electrode lead 450, specifically as follows. Figure 7 As shown, due to the staggered arrangement of the two wire electrodes 440, one of the wire electrodes 440 is located at the outer end of the positioning sleeve 410, that is, the end closer to the excitation source. Therefore, the wire connected to the wire electrode 440 at this end is directly connected to the excitation source through the notch 412 of the positioning sleeve 410. Therefore, in this embodiment, it is only necessary to open a through groove 411 with a width not less than the width of one wire for one wire electrode 440 of the distal electrode assembly 200 to pass through the electrode wire 450 to connect to the excitation source.

[0098] It should be clarified that the above description of the electrode arrangement of the distal electrode assembly 200 and the proximal electrode assembly 300 of this application, as well as the different structures of the positioning sleeve 410 of the distal electrode assembly 200 and the proximal electrode assembly 300, should be understood as follows: the foregoing description does not limit the electrode arrangement of the distal electrode assembly 200 and the proximal electrode assembly 300 to be consistent. Rather, on the basis of non-contradiction, it is possible to select one of the three embodiments of the distal electrode assembly 200 and one of the three embodiments of the proximal electrode assembly 300 respectively and combine them to obtain two or more sets of electrode assemblies, all without departing from the protection of this application.

[0099] In one embodiment, the inner tube 100 has at least a plurality of arc segments and a plurality of platform segments alternately distributed circumferentially at its distal end. The intermediate electrode 430 is arc-shaped and is disposed across at least one platform segment and two arc segments adjacent to the platform segment. The gap between the intermediate electrode 430 and the platform segment it occupies is used to accommodate adhesive. The wire electrode 440 is at least connected to the platform segment. The gap between the protective sleeve 420 and the platform segment is used to accommodate wires and / or adhesive.

[0100] Specific methods can be as follows: Figure 14 As shown, the inner cavity of the inner tube 100 has a circular cross-section, while the outer wall has a polygonal cross-section. Four platform segments are evenly distributed on the outer circumference of the inner tube 100; these platform segments are... Figure 14 The four outer planes 110 are connected by arc segments; meanwhile, the intermediate electrode 430 has an arc-shaped structure, such as... Figure 9 , 10 As shown, during installation, it is fitted onto the outer periphery of the inner tube 100. This creates a gap between the inner surface of the intermediate electrode 430 and the outer plane 110 of the inner tube 100. In this embodiment, the wire electrode 440 is connected to another platform segment, and the wire electrode 440 is located within this gap. This gap is used for routing the electrode wire 450. Adhesive is used to fill the gap to strengthen the fixation of the wire electrode 440. Specifically, as shown... Figure 2 and Figure 18 As shown, this design not only enhances the connection strength of the wires, improving the stability and durability of the electrode assembly structure under shock wave conditions, but also, by shaping the surface of the inner tube 100, facilitates the use of it as an assembly reference for mounting the intermediate electrode 430 and the wire electrode 440. This allows for rapid assembly and simultaneously defines the circumferential orientation of both, ensuring the accuracy of the subsequent excitation point. Convenient and precise assembly can be achieved without relying on complex tooling. Furthermore, the platform section effectively removes a portion of the inner tube 100, freeing up radial dimensions for accommodating the electrode wire 450 and bridging wire 460. For electrode assemblies requiring high energy delivery, this might involve selecting wires with a diameter larger than the wall thickness of the wire electrode 440. The platform section ensures that even with thicker wires, the outer contour at the connection between the wire and the wire electrode 440 can still transition smoothly, preventing the wire from being pressed under the electrode and increasing the overall diameter of the electrode assembly, and avoiding bulges on the surface of the protective sleeve 420. Further, compared to... Figure 8 and Figure 9 As can be seen, the inner tube 100 can be adapted for electrode assembly and wire routing in both the proximal electrode assembly 300 and the distal electrode assembly 200. It cleverly connects one of the wire electrodes 440 of the distal electrode assembly 200 to the electrode wire 450 and routes it to an unoccupied platform segment of the proximal electrode assembly 300 (e.g., ...). Figure 9The plateau segment where the electrode lead 450 is located on the left side of the middle section ensures that the plateau segment has a high utilization rate in both the proximal electrode assembly 300 and the distal electrode assembly 200, so as to ensure that the overall arrangement is relatively compact and ingenious, resulting in a smaller overall outer diameter of the electrode assembly and improving the catheter's ability to pass through stenotic lesions.

[0101] In some embodiments, Figure 15 , 18 The inner surface of the wire electrode 440 shown is flat, and the outer surface is arc-shaped. It was found that when the wire electrode 440 has a flat surface, the flat surface of the wire electrode 440 will have a better plane-to-plane attachment with the platform section of the inner tube 100, which is conducive to the smooth transition between the outer surface of the wire electrode 440 and the positioning sleeve 410, and ensures the uniformity of the overall shape of the electrode assembly.

[0102] Of course, in another embodiment, the cross-section of the inner tube 100 is as follows: Figure 24 As shown, the first concave surface 120 of the inner tube 100 is used to embed the wire, and the outer cylindrical surface of the inner tube 100 is used to fit and contact the inner wall of the positioning sleeve 410. The second concave surface 130 of the inner tube 100 is used to embed multiple wires, such as electrode wires 450 and bridging wires 460, so as to avoid the wires being pressed under the electrode and increasing the thickness of the electrode assembly. The second concave surface 130 and the first concave surface 120 have the same function as the platform section in other embodiments, both of which are used to ensure that the overall arrangement is more compact and exquisite, so that the overall outer diameter of the electrode assembly is smaller and the catheter's ability to pass through stenotic lesions is improved.

[0103] In one embodiment, at least two sets of electrode assemblies are included. Each set of electrode assemblies includes a positioning sleeve 410, a protective sleeve 420, an intermediate electrode 430, and two lead electrodes 440. The excitation through holes 421 of the protective sleeves 420 of each electrode assembly are staggered to achieve approximately uniform vibration over 360°, thereby providing a more uniform effect on intravascular lesions. The intermediate electrode 430 and the two lead electrodes 440 are arranged axially along the positioning sleeve 410. The platform section provides a positioning reference for the lead electrodes 440. The gap between the lead electrodes 440 and the intermediate electrode 430 is located in an arc segment and exposed by the excitation through holes 421. Specifically... Figure 9 As shown; or, the intermediate electrode 430 and the two lead electrodes 440 are offset axially from each other in the positioning sleeve 410, wherein the two plateau segments serve as positioning references for the lead electrodes 440 and the intermediate electrode 430, respectively, and the gap between the lead electrodes 440 and the intermediate electrode 430 is located in the plateau segment and exposed by the excitation through hole 421, as specifically as... Figure 4 As shown.

[0104] In this embodiment, when there are only two electrode components, the electrode components include a proximal electrode component 300 and a distal electrode component 200. The excitation vias 421 of the proximal electrode component 300 and the distal electrode component 200 are mirror-symmetrical, specifically as follows: Figure 1 As shown, this can achieve a nearly uniform vibration across 360°, thus creating a more uniform effect on vascular lesions.

[0105] In one possible implementation, the intermediate electrode 430 is provided to partially surround the inner tube 100, and the inner wall of the intermediate electrode 430 includes alternating arc-shaped segments and deformation segments, the deformation segments being straight or wavy.

[0106] Figure 15 The outer surface of the middle conductor electrode 440 is an arc surface, and the inner surface (i.e., is) Figure 15 The inner plane 480 is a plane, and in some embodiments, a groove 481 may be provided on the inner plane 480; similarly, as Figure 16 , 17 As shown, the outer surface of the intermediate electrode 430 is an arc surface, and its inner surface is provided with an inner plane 480 corresponding to the platform end of the inner tube 100. A groove 481 is provided on the inner plane 480. It can be understood that when the inner surfaces of the intermediate electrode 430 and the wire electrode 440 are fully attached to the outer surface of the inner tube 100, the gap between the surfaces of the different parts is very small. In this way, the amount of glue poured into the gap is very small, which is not conducive to electrode fixation. In this embodiment, by providing a groove 481 on the inner plane 480, a glue pouring gap is reserved, and the glue can flow into the gap formed by the groove 481. This is beneficial to electrode fixation on the one hand, and does not reduce electrode adhesion on the other hand, greatly improving the durability of the electrode under shock waves.

[0107] In one possible implementation, the two positioning sleeves 410 are integrated into a single structure via a flexible connector 470.

[0108] Specifically, such as Figure 23 As shown, the integrated positioning sleeve 410 of this application is equivalent to connecting two separate positioning sleeves 410 together through a flexible connector 470. Figure 23The flexible connector 470 consists of two straight rods, but in other embodiments, it can be three or more straight rods. These rods can be straight, curved, or spiral; they can be rods or flexible structures formed by perforation. The two or more electrode assemblies on the shockwave balloon are generally arranged with a fixed axial distance to achieve precise control of the lesion treatment length. The other two electrode assemblies are typically arranged with a certain circumferential angle deviation to achieve more uniform 360° circumferential treatment of the blood vessel wall. This implementation is to some extent equivalent to setting a plateau segment or a first concave surface 120 and a second concave surface 130, facilitating convenient limitation of the circumferential misalignment angle between electrode assemblies. Figure 23 The flexible connector 470 does not significantly increase the bending stiffness of the catheter, nor does it reduce the catheter's delivery performance. It connects the two electrode assemblies, constraining the axial distance and circumferential angle differences between them, thus achieving a more controllable spatial arrangement of the excitation point. In existing shockwave balloons, the axial distance and circumferential angle deviation between the two electrode assemblies are determined manually during assembly. Clearly, the positioning accuracy of the electrode assemblies in existing shockwave balloons is inferior to that of the electrode assemblies described in this application.

[0109] In one possible implementation, the positioning sleeve 410 is formed with a recess for accommodating the intermediate electrode 430 and the wire electrode 440 by laser cutting or punching, and / or the intermediate electrode 430 and the wire electrode 440 are obtained by laser cutting or punching.

[0110] In this embodiment, the intermediate electrode positioning hole / groove 431, the lead electrode positioning hole / groove 441 on the positioning sleeve 410, and the excitation through hole 421 on the protective sleeve 420 are fabricated by laser cutting or drilling. Furthermore, the intermediate electrode 430 and the lead electrode 440 can also be obtained by laser cutting or drilling. This allows for precise control of the spacing or width of the excitation through hole 421, the intermediate electrode positioning hole / groove 431, and the lead electrode positioning hole / groove 441. Simultaneously, it ensures that the intermediate electrode 430 and the lead electrode 440 are precisely processed according to preset standards, thereby guaranteeing the concentricity and consistency of the excitation points. This avoids the problem of unstable excitation spacing caused by manual operation errors. Stable excitation point spacing ensures uniform and consistent shock wave energy excitation, allowing the shock wave energy to act more effectively on the vascular calcification area, improving the treatment effect. At the same time, uniform and stable energy excitation reduces energy impact fluctuations during electrode operation, reduces electrode wear, effectively extends the electrode's service life, reduces medical costs, and improves the cost-effectiveness of the medical device.

[0111] It should be noted that while the number of wire electrodes 440 in each of the above embodiments has been described, the number of intermediate electrodes 430 is not limited. In this embodiment, an embodiment including three excitation vias 421 is also provided, as detailed below. Figures 26 to 28 As shown, in this embodiment, the electrode assembly has two intermediate electrodes 430, the positioning sleeve 410 is provided with two parallel intermediate electrode positioning holes / grooves 431, and the protective sleeve 420 has three excitation through holes 421 to allow conductive liquid to pass through, thereby forming three excitation points.

[0112] This application also provides a method for manufacturing a shockwave balloon catheter, applied to the aforementioned shockwave balloon catheter, comprising the following steps:

[0113] Step S1: Provide a positioning sleeve 410, and form an intermediate electrode positioning hole 431, a wire electrode positioning hole 441 and a notch 412 by laser cutting. The notch 412 is connected to the wire electrode positioning hole 441.

[0114] Step S2: Form a notch 442 on the wire electrode 440 by laser cutting; there is no requirement for the order of steps S1 and S2.

[0115] Step S3: Embed the intermediate electrode 430 and the wire electrode 440 into the intermediate electrode positioning hole 431 and the wire electrode positioning hole 441, respectively;

[0116] Step S4: Pass the end of the wire through the notch 412 and place it in the notch 442 of the wire electrode 440, and then weld it in place;

[0117] Step S5: Place the protective sleeve 420 around the outer periphery of the positioning sleeve 410, and align the excitation through hole 421 with the gap between the intermediate electrode 430 and the wire electrode 440 to obtain an electrode pair composed of the intermediate electrode 430 and the wire electrode 440.

[0118] In some embodiments, the method further includes providing an inner tube 100 before S1, and machining a platform segment or a first concave section at a designated location in the inner tube 100 to arrange the wire routing without increasing the outer diameter. In some embodiments, the method further includes placing a balloon over the electrode assembly consisting of the positioning sleeve 410, the protective sleeve 420, the intermediate electrode 430, and the wire electrode 440 after S5.

[0119] In summary, this application provides a shockwave balloon catheter in which, during shockwave balloon operation, electrical energy generated by a high-voltage generator is transmitted through wires to the lead electrode 440 and intermediate electrode 430. Due to the unique embedded connection structure of this invention, the electrode assembly as a whole forms a highly efficient electric field generating system. When electrical energy acts on the electrodes, a strong electrohydraulic shock wave is generated in the conductive solution medium inside the balloon. The positioning sleeve 410, which also serves as an insulating layer, not only effectively isolates electrical interference between the electrodes, ensuring that electrical energy is transmitted along a predetermined path, but also provides stable physical support for the electrode assembly. This embedded design and the special surface morphology design of the inner tube 100 significantly reduce the outer diameter of the electrode assembly, improving the catheter's ability to pass through stenotic lesions. Moreover, the special surface morphology design of the inner tube 100 provides space for glue injection and bonding for electrode assembly fixation, improving the efficiency of the catheter. The robustness and durability of the electrode assembly ensure stable operation of the shockwave balloon. The embedded connection between the lead electrode 440 and the lead wire enhances the connection strength, ensuring the integrity and functional stability of the electrode assembly. The stable excitation point spacing formed by laser cutting or perforation, the shape design of the inner tube 100 for easy positioning and wiring, and the integrated positioning sleeve 410 design ensure uniform spatial distribution and stable excitation of shockwave energy. The uniform and stable shockwave energy can be precisely focused on the calcified area of ​​the blood vessel, using cavitation effect and mechanical impact to break up the calcified material, restore vascular elasticity, and achieve effective treatment of diseased blood vessels. At the same time, due to the compact structure and stable connection of the electrode assembly, it can maintain good stability during operation, reduce energy loss and unnecessary mechanical vibration, and further improve treatment efficiency and safety.

[0120] It should be noted that in this specification, relational terms such as "first" and "second" are used only to distinguish one entity from several other entities, and do not necessarily require or imply any such actual relationship or order between these entities. The various embodiments in this specification are described in a progressive manner, with each embodiment focusing on its differences from other embodiments. Similar or identical parts between embodiments can be referred to interchangeably.

[0121] The embodiments provided by the present invention have been described in detail above. Specific examples have been used to illustrate the principles and implementation methods of the present invention. The description of the above embodiments is only for the purpose of helping to understand the method and core ideas of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made to the present invention without departing from the principles of the present invention, and these improvements and modifications also fall within the protection scope of the present invention.

Claims

1. A shockwave balloon catheter, characterized in that, include: A balloon that can be filled with a conductive solution; The inner tube (100) is a hollow tubular structure, the distal end of which can extend into the interior of the balloon. The electrode assembly includes a positioning sleeve (410), a protective sleeve (420), an intermediate electrode (430), and a lead electrode (440). The positioning sleeve (410) and the protective sleeve (420) are coaxially sleeved on the inner tube (100) from the inside to the outside. The intermediate electrode (430) and the lead electrode (440) are respectively embedded in the positioning sleeve (410). The protective sleeve (420) is provided with an excitation through hole (421) for exposing at least a portion of the intermediate electrode (430) and at least a portion of the lead electrode (440), so that the intermediate electrode (430) and the lead electrode (440) form an electrode pair. A wire, at least one end of which is embedded in the positioning sleeve (410) and connected to the wire electrode (440), the wire and the wire electrode (440) are connected to form an assembly, the maximum radial height of the assembly does not exceed the outer circumferential surface of the positioning sleeve (410), so that the protective sleeve (420) sleeved outside the assembly has a smooth cylindrical structure. The wire electrode (440) is provided with a notch (442), and the positioning sleeve (410) is provided with a notch (412). One end of the wire extends into the notch (412) and is embedded in the notch (442).

2. The shockwave balloon catheter according to claim 1, characterized in that, The device includes at least two sets of electrode assemblies. The wires include bridging wires (460) and electrode wires (450). Each electrode assembly is connected in series through the bridging wires (460). The entire electrode assembly is connected to an excitation source through the electrode wires (450). Each electrode assembly includes a positioning sleeve (410), a protective sleeve (420), an intermediate electrode (430), and two wire electrodes (440). The excitation through-holes (421) opened in the protective sleeves (420) of each electrode assembly have different orientations.

3. The shockwave balloon catheter according to claim 2, characterized in that, It includes two sets of electrode assemblies, namely a distal electrode assembly (200) and a proximal electrode assembly (300). The two lead electrodes (440) of the distal electrode assembly (200) are respectively connected to the bridging lead (460) and an electrode lead (450), and both lead electrodes (440) of the distal electrode assembly (200) have notches (442) facing the proximal end. The wire electrode (440) of the proximal electrode assembly (300) for connecting the bridging wire (460) has a notch (442) facing the distal end, and the wire electrode (440) of the proximal electrode assembly (300) for connecting the electrode wire (450) has a notch (442) facing the proximal end or the distal end.

4. The shockwave balloon catheter according to claim 2, characterized in that, The electrode assembly includes a distal electrode assembly (200), which includes at least two electrode pairs formed by the intermediate electrode (430) and the two conductive electrodes (440); The intermediate electrode (430) and the two wire electrodes (440) are arranged in a row along the axial direction of the positioning sleeve (410), with the intermediate electrode (430) located between the two wire electrodes (440), or... The intermediate electrode (430) and the two wire electrodes (440) are offset from each other in the axial direction of the positioning sleeve (410), and the two wire electrodes (440) are located on the same side or on both sides of the intermediate electrode (430).

5. The shockwave balloon catheter according to claim 2, characterized in that, The electrode assembly includes a proximal electrode assembly (300), which includes at least two electrode pairs formed by the intermediate electrode (430) and the two wire electrodes (440); The positioning sleeve (410) of the proximal electrode assembly (300) is a non-closed annular component, which has a plurality of through grooves (411) extending axially, through grooves (411) for the electrode wire (450) to be embedded through. The intermediate electrode (430) and the two conductive electrodes (440) are arranged in a row along the axial direction of the positioning sleeve (410), and the width of the through groove (411) is not less than the width of one of the electrode conductive wires (450), or, The intermediate electrode (430) and the two wire electrodes (440) are offset axially from each other in the positioning sleeve (410). Both wire electrodes (440) are located on the same side of the intermediate electrode (430). The total width of the through groove (411) is not less than the sum of the widths of the two electrode wires (450), or... The intermediate electrode (430) and the two wire electrodes (440) are offset from each other in the axial direction of the positioning sleeve (410). The two wire electrodes (440) are located on both sides of the intermediate electrode (430). The width of the through groove (411) is not less than the width of one of the electrode wires (450).

6. The shockwave balloon catheter according to claim 1, characterized in that, The inner tube (100) has at least a plurality of arc segments and a plurality of platform segments alternately distributed circumferentially at its distal end. The intermediate electrode (430) is arc-shaped and spans at least one platform segment and two arc segments adjacent to the platform segment. The gap between the intermediate electrode (430) and the platform segment it spans is used to accommodate adhesive. The wire electrode (440) is at least connected to the platform segment. The gap between the protective sleeve (420) and the platform segment is used to accommodate wires and / or adhesive.

7. The shockwave balloon catheter according to claim 6, characterized in that, It includes at least two sets of the electrode assemblies, each set of the electrode assemblies including the positioning sleeve (410), the protective sleeve (420), the intermediate electrode (430) and the two wire electrodes (440), and the excitation through holes (421) of the protective sleeve (420) of each electrode assembly are staggered from each other; in, The intermediate electrode (430) and the two wire electrodes (440) are arranged in a row along the axial direction of the positioning sleeve (410). The platform segment provides a positioning reference for the wire electrodes (440). The gap between the wire electrodes (440) and the intermediate electrode (430) is located in the arc segment and exposed by the excitation through hole (421); or, The intermediate electrode (430) and the two wire electrodes (440) are offset in the axial direction of the positioning sleeve (410). The two platform segments provide positioning references for the wire electrodes (440) and the intermediate electrode (430) respectively. The gap between the wire electrode (440) and the intermediate electrode (430) is located in the platform segment and exposed by the excitation through hole (421).

8. The shockwave balloon catheter according to claim 1, characterized in that, The intermediate electrode (430) is partially surrounded by the inner tube (100), and the inner wall of the intermediate electrode (430) includes alternating arc-shaped segments and deformation segments, wherein the deformation segments are straight or wavy; and / or, The inner tube (100) is provided with a first concave surface (120) for embedding a wire.

9. The shockwave balloon catheter according to claim 1, characterized in that, The two positioning sleeves (410) are integrated into a single structure through a flexible connector (470).

10. A method for manufacturing a shockwave balloon catheter, characterized in that, The application of the shockwave balloon catheter as described in any one of claims 1-9 includes the following steps: A positioning sleeve (410) is provided, and a positioning hole (431), a wire electrode positioning hole (441) and a notch (412) are formed by laser cutting. The notch (412) is connected to the wire electrode positioning hole (441). A notch (442) is formed on the wire electrode (440) by laser cutting. The intermediate electrode (430) and the wire electrode (440) are respectively embedded in the intermediate electrode positioning hole (431) and the wire electrode positioning hole (441); The end of the wire is passed through the notch (412) and placed in the notch (442) of the wire electrode (440), and then welded and fixed. The protective sleeve (420) is fitted around the outer periphery of the positioning sleeve (410), and the excitation through hole (421) is aligned with the gap between the intermediate electrode (430) and the lead electrode (440) to obtain an electrode pair consisting of the intermediate electrode (430) and the lead electrode (440).

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