Shock wave balloon catheter device

By designing a combination structure of multiple electrode pairs in the shock wave balloon catheter device, the shock wave energy is enhanced and evenly distributed, solving the problems of insufficient energy and uneven distribution in existing devices, and achieving effective rupture and safe treatment of harder calcified plaques.

CN120814877APending Publication Date: 2025-10-21SUZHOU RAINMED INTELLIGENT TECH DEV LTD
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Patent Information

Application Number
CN202410410910.0
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-04-07
Publication Date
2025-10-21

AI Technical Summary

Technical Problem

When existing shock wave balloon catheter devices are used to rupture harder calcified plaques, the shock wave energy is insufficient and unevenly distributed, resulting in some calcified plaques not being effectively impacted.

Method used

A shock wave balloon catheter device is designed, which adopts a combination structure of multiple electrode pairs. Through the insulating separation of the outer electrode sheath and the inner electrode assembly, multiple electrode pairs are formed to generate a discharge arc in the liquid, which enhances the shock wave energy. The electrode pairs are distributed in the circumferential and axial directions to enhance the coverage of the shock wave.

Benefits of technology

The increased shock wave energy enables more effective rupture of harder calcified plaques, and the application of shock waves at multiple locations along the circumference of the blood vessel improves treatment efficacy and reduces the risk of complications such as dissection and perforation.

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Abstract

The embodiment of the invention provides a shock wave balloon catheter device. The shock wave balloon catheter device comprises a first outer electrode sheath; the first inner electrode comprises a first discharging part and a first fixing part; the second inner electrode comprises a second discharging part and a second fixing part; the first fixing part and the second fixing part are positioned between the outer wall of the catheter and the inner wall of the first outer electrode sheath; a second external electrode sheath; the third inner electrode comprises a third discharging part and a third fixing part; the fourth inner electrode comprises a fourth discharging part and a fourth fixing part; the third fixing part and the fourth fixing part are positioned between the outer wall of the catheter and the inner wall of the second outer electrode sheath; the first discharge part and the second discharge part respectively form an electrode pair with the first outer electrode sheath; the third discharge part and the fourth discharge part respectively form an electrode pair with the first outer electrode sheath; wherein three electrode pairs are close to each other to generate shock waves which are mutually interfered and enhanced at local positions in the circumferential direction, and the other electrode pair generates shock waves at other circumferential positions, so that the shock waves are applied to two positions in the circumferential direction.
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Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a shock wave balloon catheter device. Background Art

[0002] As heart disease patients age and their disease progresses, plaques in peripheral blood vessels and coronary arteries gradually calcify. This bone-like structure can cause vascular narrowing, reduce blood flow, and ultimately lead to complete vascular occlusion. A shock wave balloon catheter device is provided to treat vascular calcification. During treatment, a balloon on the catheter is advanced to the calcified area of ​​the vessel. The balloon is then inflated and pressurized with fluid. High-voltage pulses are applied to the electrode pairs in the balloon, causing them to discharge and generate shock waves in the fluid. The shock waves strike the balloon wall, rupturing the calcified plaque. After the plaque ruptures, the balloon can be further inflated to open the vessel.

[0003] In some embodiments of shock wave balloon catheter devices, a portion of the catheter within the balloon is provided with multiple, spaced-apart electrode pairs. It is desirable that the shock waves generated by these multiple electrode pairs be as strong as possible, enabling them to rupture harder calcified plaques. Furthermore, calcified plaques within a blood vessel may be distributed across multiple circumferential regions. The more concentrated the shock waves generated by these electrode pairs are, the greater the likelihood that at least some of the calcified plaques will not be affected by the shock waves. Therefore, the shock waves generated by these multiple electrode pairs can be distributed across as many circumferential regions as possible, enabling them to rupture calcified plaques distributed across multiple locations around the vessel. Summary of the Invention

[0004] An embodiment of the present application provides a shock wave balloon catheter device that can enhance shock wave energy and distribute the shock wave to multiple areas in a circumferential direction.

[0005] In one embodiment of the present application, a shock wave balloon catheter device is provided, comprising a catheter, a balloon sealed around the outer circumference of the catheter, a first electrode assembly and a second electrode assembly disposed in the balloon, wherein the balloon can be filled with a liquid;

[0006] The first electrode assembly includes

[0007] a first outer electrode sheath; the first outer electrode sheath is sleeved on the outer periphery of the catheter;

[0008] a first inner electrode; the first inner electrode comprises a first discharge portion and a first fixing portion; the first fixing portion is located between the outer wall of the catheter and the inner wall of the first outer electrode sheath; the first discharge portion can contact the liquid in the balloon; the first outer electrode sheath and the first inner electrode are configured to be insulated and separated;

[0009] a second inner electrode; the second inner electrode includes a second discharge portion and a second fixing portion; the second fixing portion is located between the outer wall of the catheter and the inner wall of the first outer electrode sheath; the second discharge portion can contact the liquid in the balloon; the second discharge portion and the first discharge portion are arranged at intervals along the circumference of the catheter; the first outer electrode sheath and the second inner electrode are configured to be insulated and separated;

[0010] The second electrode assembly includes

[0011] a second outer electrode sheath; the second outer electrode sheath is sleeved on the outer periphery of the catheter; and the second outer electrode sheath and the first outer electrode sheath are spaced apart in the axial direction;

[0012] a third inner electrode; the third inner electrode comprises a third discharge portion and a third fixing portion; the third fixing portion is located between the outer wall of the catheter and the inner wall of the second outer electrode sheath; the third discharge portion can contact the liquid in the balloon; the third inner electrode is electrically connected to the second inner electrode; the second outer electrode sheath and the third inner electrode are configured to be insulated and separated;

[0013] a fourth inner electrode; the fourth inner electrode comprising a fourth discharge portion and a fourth fixing portion; the fourth fixing portion being located between the outer wall of the catheter and the inner wall of the second outer electrode sheath; the fourth discharge portion being capable of contacting the liquid within the balloon; the fourth discharge portion and the third discharge portion being spaced apart along the circumference of the catheter; and the second outer electrode sheath and the fourth inner electrode being configured to be insulated and separated;

[0014] When a voltage is applied between the first inner electrode and the fourth inner electrode, an electrode pair formed between the first discharge portion and the first outer electrode sheath can generate a discharge arc in the liquid, an electrode pair formed between the first outer electrode sheath and the second discharge portion can generate a discharge arc in the liquid, an electrode pair formed between the third discharge portion and the second outer electrode sheath can generate a discharge arc in the liquid, and an electrode pair formed between the second outer electrode sheath and the fourth discharge portion can generate a discharge arc in the liquid; so that current is allowed to flow through the first discharge portion, the first outer electrode sheath, the second discharge portion, the third discharge portion, the second outer electrode sheath, and the fourth discharge portion in sequence;

[0015] The first discharge portion and the second discharge portion have a first circumferential gap and a second circumferential gap along the circumferential direction; the circumferential angle corresponding to the first circumferential gap is greater than 30° and less than 150°; the circumferential angle corresponding to the second circumferential gap is greater than the circumferential angle corresponding to the first circumferential gap;

[0016] Among the third discharge portion and the fourth discharge portion, at least a portion of the circumferential position of one discharge portion is located in the first circumferential gap, and the circumferential position of the other discharge portion is located in the second circumferential gap; a first circumferential gap is formed between the one discharge portion and the first discharge portion, and a first second circumferential gap is formed between the one discharge portion and the second discharge portion; a second circumferential gap is formed between the other discharge portion and the first discharge portion, and a second second circumferential gap is formed between the other discharge portion and the second discharge portion;

[0017] The circumferential angle corresponding to the first circumferential gap is smaller than the circumferential angle corresponding to the second circumferential gap, and the circumferential angle corresponding to the first circumferential gap is smaller than the circumferential angle corresponding to the second circumferential gap;

[0018] The circumferential angle corresponding to the first two circumferential gaps is smaller than the circumferential angle corresponding to the second circumferential gap, and the circumferential angle corresponding to the first two circumferential gaps is smaller than the circumferential angle corresponding to the second two circumferential gaps.

[0019] Another embodiment of the present application provides a shock wave balloon catheter device, comprising a catheter, a balloon sealed around the outer circumference of the catheter, a first electrode assembly and a second electrode assembly disposed in the balloon, wherein the balloon can be filled with a liquid;

[0020] The first electrode assembly includes

[0021] a first outer electrode sheath; the first outer electrode sheath is sleeved on the outer periphery of the catheter;

[0022] a first inner electrode; the first inner electrode comprises a first discharge portion and a first fixing portion; the first fixing portion is located between the outer wall of the catheter and the inner wall of the first outer electrode sheath; the first discharge portion can contact the liquid in the balloon; the first outer electrode sheath and the first inner electrode are configured to be insulated and separated;

[0023] a second inner electrode; the second inner electrode includes a second discharge portion and a second fixing portion; the second fixing portion is located between the outer wall of the catheter and the inner wall of the first outer electrode sheath; the second discharge portion can contact the liquid in the balloon; the second discharge portion and the first discharge portion are arranged at intervals along the circumference of the catheter; the first outer electrode sheath and the second inner electrode are configured to be insulated and separated;

[0024] The second electrode assembly includes

[0025] a second outer electrode sheath; the second outer electrode sheath is sleeved on the outer periphery of the catheter; and the second outer electrode sheath and the first outer electrode sheath are spaced apart in the axial direction;

[0026] a third inner electrode; the third inner electrode comprises a third discharge portion and a third fixing portion; the third fixing portion is located between the outer wall of the catheter and the inner wall of the second outer electrode sheath; the third discharge portion can contact the liquid in the balloon; the third inner electrode is electrically connected to the second inner electrode; the second outer electrode sheath and the third inner electrode are configured to be insulated and separated;

[0027] a fourth inner electrode; the fourth inner electrode comprising a fourth discharge portion and a fourth fixing portion; the fourth fixing portion being located between the outer wall of the catheter and the inner wall of the second outer electrode sheath; the fourth discharge portion being capable of contacting the liquid within the balloon; the fourth discharge portion and the third discharge portion being spaced apart along the circumference of the catheter; and the second outer electrode sheath and the fourth inner electrode being configured to be insulated and separated;

[0028] When a voltage is applied between the first inner electrode and the fourth inner electrode, a first electrode pair formed between the first discharge portion and the first outer electrode sheath can generate a discharge arc in the liquid, a second electrode pair formed between the first outer electrode sheath and the second discharge portion can generate a discharge arc in the liquid, a third electrode pair formed between the third discharge portion and the second outer electrode sheath can generate a discharge arc in the liquid, and a fourth electrode pair formed between the second outer electrode sheath and the fourth discharge portion can generate a discharge arc in the liquid; so that current is allowed to sequentially pass through the first discharge portion, the first outer electrode sheath, the second discharge portion, the third discharge portion, the second outer electrode sheath, and the fourth discharge portion;

[0029] The first discharge portion and the second discharge portion have a first circumferential gap along the circumference; the circumferential angle corresponding to the first circumferential gap is greater than 30° and less than 150°

[0030] The third discharge portion and the fourth discharge portion are substantially symmetrically arranged along the axis; and at least a portion of a circumferential position of one of the third discharge portion and the fourth discharge portion is located within the first circumferential gap.

[0031] Another embodiment of the present application provides a shock wave balloon catheter device, comprising a catheter, a balloon sealed around the outer circumference of the catheter, a first electrode assembly and a second electrode assembly disposed in the balloon, wherein the balloon can be filled with a liquid;

[0032] The first electrode assembly includes

[0033] a first outer electrode sheath; the first outer electrode sheath is sleeved on the outer periphery of the catheter;

[0034] a first inner electrode; the first inner electrode comprises a first discharge portion and a first fixing portion; the first fixing portion is located between the outer wall of the catheter and the inner wall of the first outer electrode sheath; the first discharge portion can contact the liquid in the balloon; the first outer electrode sheath and the first inner electrode are configured to be insulated and separated;

[0035] a second inner electrode; the second inner electrode includes a second discharge portion and a second fixing portion; the second fixing portion is located between the outer wall of the catheter and the inner wall of the first outer electrode sheath; the second discharge portion can contact the liquid in the balloon; the second discharge portion and the first discharge portion are arranged at intervals along the circumference of the catheter; the first outer electrode sheath and the second inner electrode are configured to be insulated and separated;

[0036] The second electrode assembly includes

[0037] a second outer electrode sheath; the second outer electrode sheath is sleeved on the outer periphery of the catheter; and the second outer electrode sheath and the first outer electrode sheath are spaced apart in the axial direction;

[0038] a third inner electrode; the third inner electrode comprises a third discharge portion and a third fixing portion; the third fixing portion is located between the outer wall of the catheter and the inner wall of the second outer electrode sheath; the third discharge portion can contact the liquid in the balloon; the third inner electrode is electrically connected to the second inner electrode; the second outer electrode sheath and the third inner electrode are configured to be insulated and separated;

[0039] a fourth inner electrode; the fourth inner electrode comprising a fourth discharge portion and a fourth fixing portion; the fourth fixing portion being located between the outer wall of the catheter and the inner wall of the second outer electrode sheath; the fourth discharge portion being capable of contacting the liquid within the balloon; the fourth discharge portion and the third discharge portion being spaced apart along the circumference of the catheter; and the second outer electrode sheath and the fourth inner electrode being configured to be insulated and separated;

[0040] When a voltage is applied between the first inner electrode and the fourth inner electrode, a first electrode pair formed between the first discharge portion and the first outer electrode sheath can generate a discharge arc in the liquid, a second electrode pair formed between the first outer electrode sheath and the second discharge portion can generate a discharge arc in the liquid, a third electrode pair formed between the third discharge portion and the second outer electrode sheath can generate a discharge arc in the liquid, and a fourth electrode pair formed between the second outer electrode sheath and the fourth discharge portion can generate a discharge arc in the liquid; so that current is allowed to sequentially pass through the first discharge portion, the first outer electrode sheath, the second discharge portion, the third discharge portion, the second outer electrode sheath, and the fourth discharge portion;

[0041] The first discharge portion and the second discharge portion have a first circumferential gap and a second circumferential gap along the circumferential direction; the circumferential angle corresponding to the first circumferential gap is greater than 30° and less than 150°; the circumferential angle corresponding to the second circumferential gap is greater than the circumferential angle corresponding to the first circumferential gap;

[0042] Among the third discharge portion and the fourth discharge portion, at least a portion of the circumferential position of one discharge portion is located in the first circumferential gap, and the circumferential position of the other discharge portion is located approximately at the center of the second circumferential gap.

[0043] Yet another embodiment of the present application provides a shock wave balloon catheter device, comprising a catheter, and a balloon sealed around the outer circumference of the catheter, wherein the balloon can be filled with a liquid;

[0044] a first outer electrode sheath; the first outer electrode sheath is sleeved on the outer periphery of the catheter;

[0045] a second outer electrode sheath; the second outer electrode sheath is sleeved on the outer periphery of the catheter; and the second outer electrode sheath and the first outer electrode sheath are spaced apart in the axial direction;

[0046] a first insulated wire; a portion of the first insulated wire is crimped between the outer wall of the catheter and the inner wall of the first outer electrode sheath; a portion of the insulation layer of the first insulated wire is removed to form a first discharge portion; the first discharge portion can contact the liquid in the balloon;

[0047] a second insulated conductor; a portion of the second insulated conductor is crimped between the outer wall of the catheter and the inner wall of the first outer electrode sheath, and another portion of the second insulated conductor is crimped between the outer wall of the catheter and the inner wall of the second outer electrode sheath; a portion of the insulation layer of the second insulated conductor is removed to form a second discharge portion, and another portion of the insulation layer of the second insulated conductor is removed to form a third discharge portion; both the second discharge portion and the third discharge portion can contact the liquid in the balloon;

[0048] a third insulated wire; a portion of the third insulated wire is crimped between the outer wall of the catheter and the inner wall of the second outer electrode sheath; a portion of the insulation layer of the third insulated wire is removed to form a fourth discharge portion; the fourth discharge portion can contact the liquid in the balloon;

[0049] When a voltage is applied between the first insulated wire and the third insulated wire, a first electrode pair formed between the first discharge portion and the first outer electrode sheath can generate a discharge arc in the liquid, a second electrode pair formed between the first outer electrode sheath and the second discharge portion can generate a discharge arc in the liquid, a third electrode pair formed between the third discharge portion and the second outer electrode sheath can generate a discharge arc in the liquid, and a fourth electrode pair formed between the second outer electrode sheath and the fourth discharge portion can generate a discharge arc in the liquid; so as to allow current to sequentially pass through the first discharge portion, the first outer electrode sheath, the second discharge portion, the third discharge portion, the second outer electrode sheath, and the fourth discharge portion;

[0050] The first discharge portion and the second discharge portion have a first circumferential gap and a second circumferential gap along the circumferential direction; the circumferential angle corresponding to the first circumferential gap is greater than 30° and less than 150°; the circumferential angle corresponding to the second circumferential gap is greater than the circumferential angle corresponding to the first circumferential gap;

[0051] Among the third discharge portion and the fourth discharge portion, at least a portion of the circumferential position of one discharge portion is located in the first circumferential gap, and the circumferential position of the other discharge portion is located in the second circumferential gap; a first circumferential gap is formed between the one discharge portion and the first discharge portion, and a first second circumferential gap is formed between the one discharge portion and the second discharge portion; a second circumferential gap is formed between the other discharge portion and the first discharge portion, and a second second circumferential gap is formed between the other discharge portion and the second discharge portion;

[0052] The circumferential angle corresponding to the first circumferential gap is smaller than the circumferential angle corresponding to the second circumferential gap, and the circumferential angle corresponding to the first circumferential gap is smaller than the circumferential angle corresponding to the second-second circumferential gap; the circumferential angle corresponding to the first-second circumferential gap is smaller than the circumferential angle corresponding to the second circumferential gap, and the circumferential angle corresponding to the first-second circumferential gap is smaller than the circumferential angle corresponding to the second-second circumferential gap.

[0053] In the above embodiment, among the four electrode pairs, three electrode pairs generate mutually interference-enhanced shock waves at local circumferential positions, and another electrode pair generates shock waves at other circumferential positions, thereby applying shock waves at two circumferential positions. BRIEF DESCRIPTION OF THE DRAWINGS

[0054] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present application. For those skilled in the art, other drawings can be obtained based on these drawings without expending creative labor.

[0055] Figure 1 A schematic structural diagram of a shock wave balloon catheter device provided in one embodiment of the present application;

[0056] Figure 2 A longitudinal cross-sectional view of a first electrode assembly provided in one embodiment of the present application;

[0057] Figure 3 A schematic structural diagram of an electrode assembly provided in the first embodiment of the present application;

[0058] Figure 4 A schematic structural diagram of an electrode assembly provided in a second embodiment of the present application;

[0059] Figure 5 A schematic structural diagram of an electrode assembly provided in a third embodiment of the present application;

[0060] Figure 6 A schematic structural diagram of an electrode assembly provided in a third embodiment of the present application;

[0061] Figure 7 For this application Figure 6 A schematic structural diagram of the first discharge portion and the second discharge portion in the AA direction view;

[0062] Figure 8 For this application Figure 6 A schematic structural diagram of the first discharge portion, the second discharge portion, the third discharge portion, and the fourth discharge portion in the BB direction view;

[0063] Figure 9 A schematic structural diagram of a solution with three electrode assemblies provided for the third embodiment of the present application;

[0064] Figure 10 A schematic diagram of an exploded view of an electrode assembly provided in accordance with one embodiment of the present application. DETAILED DESCRIPTION

[0065] The technical solution of the present invention will be described in detail below in conjunction with the accompanying drawings and specific embodiments. It should be understood that these embodiments are only used to illustrate the present invention and are not used to limit the scope. After reading the present invention, modifications of various equivalent forms of the present invention by those skilled in the art all fall within the scope defined in this application.

[0066] It should be noted that when an element is referred to as being "disposed on" another element, it may be directly on the other element or there may be an intermediate element. When an element is referred to as being "connected to" another element, it may be directly connected to the other element or there may be an intermediate element. In this application, "proximal end" refers to the side closer to the operator, and "distal end" refers to the side farther from the operator.

[0067] The following will be combined Figures 1 to 10 The shock wave balloon catheter device according to the embodiments of this specification is explained and described. It should be noted that, in the embodiments of the present invention, the same reference numerals represent the same components. For the sake of brevity, detailed descriptions of the same components in different embodiments are omitted, and the descriptions of the same components can be cross-referenced and referenced.

[0068] As heart disease patients age and their disease progresses, plaques in peripheral blood vessels and coronary arteries gradually calcify. This bone-like structure can narrow the vessels, reduce blood flow, and ultimately lead to complete occlusion.

[0069] The shock wave balloon catheter device is indicated for interventional treatment of vascular calcifications. The device comprises a catheter, a balloon sealed around the catheter, and at least one electrode pair disposed within the balloon. The balloon can be filled with a liquid. Each electrode pair comprises a first electrode and a second electrode. When a voltage is applied between the first and second electrodes, a plasma arc is formed between the first and second electrodes in the liquid within the balloon, thereby generating bubbles within the liquid. These bubbles expand and collapse, subsequently generating a mechanical shock wave within the balloon. The mechanical shock wave is mechanically transmitted through the liquid and balloon to apply mechanical force or pressure to disrupt any calcified plaque on or in the wall of the vascular system.

[0070] During clinical use, the device is first delivered to the site of a calcified lesion in a deflated state and pressurized to ensure a tight fit against the vessel wall. A voltage is then applied between the first and second electrodes, creating a discharge shock wave within the balloon's fluid. This shock wave impacts and disrupts the calcified lesion, causing calcified fractures in the intima and media. The effectiveness of the modified lesion can be assessed by evaluating the symmetric expansion of the balloon.

[0071] The shock wave balloon catheter device effectively and safely destroys both superficial and deep calcifications, significantly improving vascular compliance. The device is effective not only for superficial and deep calcifications, but also for both eccentric and non-eccentric lesions, reducing the risk of complications such as dissection and perforation.

[0072] In some schemes of shock wave balloon catheter devices, there are multiple electrode pairs arranged axially in the balloon; experiments show that when the distance between two adjacent electrode pairs is small enough (for example, less than 6 mm), the shock waves generated by the two adjacent electrode pairs will interfere with each other, thereby enhancing the shock wave energy, and the smaller the distance between the two adjacent electrode pairs, the greater the enhanced shock wave energy; and when the distance between two adjacent electrode pairs is large enough (for example, greater than 6 mm), the shock waves generated by the two adjacent electrode pairs will not interfere with each other, and the shock wave energy generated by each electrode pair is less than the above-mentioned enhanced shock wave energy. The enhancement of shock wave energy enables it to rupture calcified plaques with greater hardness. Therefore, the structural design of the electrode pairs should facilitate the axially arranged electrode pairs to be close to each other to an appropriate distance.

[0073] In some embodiments of the shock wave balloon catheter device, the balloon includes multiple electrode pairs arranged circumferentially along the catheter. When the angle (central angle) between two electrode pairs arranged circumferentially along the catheter is sufficiently small (for example, the angle between the two electrode pairs is greater than 30° and less than 150°), the shock waves generated by the two electrode pairs interfere with each other, thereby enhancing the shock wave energy. When the angle between the two electrode pairs is sufficiently large (for example, greater than 150°), the shock waves generated by the two electrode pairs do not interfere with each other, and the shock wave energy generated by each electrode pair is less than the enhanced shock wave energy.

[0074] In some embodiments of shock wave balloon catheter devices, a portion of the catheter within the balloon is provided with multiple electrode pairs arranged at intervals. The desired situation is that: on the one hand, the shock wave energy generated by the multiple electrode pairs is as strong as possible, so that it can rupture harder calcified plaques; on the other hand, calcified plaques on a blood vessel may be distributed in multiple circumferential regions of the vessel. The more concentrated the shock waves generated by the electrode pairs are in the circumferential direction, the greater the likelihood that at least some of the calcified plaques will not be affected by the shock waves. Therefore, the shock waves generated by the multiple electrode pairs can be distributed in as many circumferential regions as possible, so that they can rupture calcified plaques distributed in multiple locations along the circumference of the vessel.

[0075] To solve the above technical problems, the present application provides an optional shock wave balloon catheter device, such as Figure 1 , comprising a catheter 1, a balloon 2 sealed around the outer circumference of the catheter 1, a first electrode assembly and a second electrode assembly disposed in the balloon 2; the balloon 2 can be filled with a liquid, wherein the liquid includes but is not limited to water, saline, a contrast agent and a mixture thereof;

[0076] The first electrode assembly is Figure 2 ,include

[0077] A first outer electrode sheath 101; the first outer electrode sheath 101 is sleeved on the outer circumference of the catheter 1;

[0078] a first inner electrode 102; the first inner electrode 102 includes a first discharge portion 1021 and a first fixing portion; the first fixing portion is located between the outer wall of the catheter 1 and the inner wall of the first outer electrode sheath 101; the first discharge portion 1021 can contact the liquid in the balloon 2; the first outer electrode sheath 101 and the first inner electrode 102 are configured to be insulated and separated;

[0079] a second inner electrode 103; the second inner electrode 103 includes a second discharge portion 1031 and a second fixing portion; the second fixing portion is located between the outer wall of the catheter 1 and the inner wall of the first outer electrode sheath 101; the second discharge portion 1031 can contact the liquid in the balloon 2; the second discharge portion 1031 and the first discharge portion 1021 are arranged at intervals along the circumference of the catheter 1; the first outer electrode sheath 101 and the second inner electrode 103 are configured to be insulated and separated;

[0080] The second electrode assembly includes

[0081] A second outer electrode sheath 104; the second outer electrode sheath 104 is sleeved on the outer periphery of the catheter 1; and the second outer electrode sheath 104 and the first outer electrode sheath 101 are spaced apart in the axial direction;

[0082] a third inner electrode; the third inner electrode comprises a third discharge portion 1051 and a third fixing portion; the third fixing portion is located between the outer wall of the catheter 1 and the inner wall of the second outer electrode sheath 104; the third discharge portion 1051 can contact the liquid in the balloon 2; the third inner electrode is electrically connected to the second inner electrode 103; the second outer electrode sheath 104 and the third inner electrode are configured to be insulated and separated;

[0083] a fourth inner electrode; the fourth inner electrode includes a fourth discharge portion 1061 and a fourth fixing portion; the fourth fixing portion is located between the outer wall of the catheter 1 and the inner wall of the second outer electrode sheath 104; the fourth discharge portion 1061 can contact the liquid in the balloon 2; the fourth discharge portion 1061 and the third discharge portion 1051 are arranged at intervals along the circumference of the catheter 1; the second outer electrode sheath 104 and the fourth inner electrode are configured to be insulated and separated;

[0084] When a voltage is applied between the first inner electrode 102 and the fourth inner electrode, a first electrode pair is formed between the first discharge portion 1021 and the first outer electrode sheath 101, a discharge arc is generated in the liquid, a second electrode pair is formed between the first outer electrode sheath 101 and the second discharge portion 1031, a discharge arc is generated in the liquid, a third electrode pair is formed between the third discharge portion 1051 and the second outer electrode sheath 104, a discharge arc is generated in the liquid, and a fourth electrode pair is formed between the second outer electrode sheath 104 and the fourth discharge portion 1061, so that current is allowed to sequentially pass through the first discharge portion 1021, the first outer electrode sheath 101, the second discharge portion 1031, the third discharge portion 1051, the second outer electrode sheath 104, and the fourth discharge portion 1061.

[0085] The circumferential direction in the embodiment of the present application is based on the axis of the catheter 1.

[0086] This application provides a first optional embodiment of the above device, such as Figure 3 The first discharge section 1021 and the second discharge section 1031 are circumferentially spaced at an angle of 180°. The first discharge section 1021 and the fourth discharge section 1061 are located at substantially the same circumferential position, and the distance between the first electrode pair and the fourth electrode pair is between 1-5 mm, so that the shock waves generated by them interfere with each other, thereby enhancing the shock wave energy. The second discharge section 1031 and the third discharge section 1051 are located at substantially the same circumferential position, and the distance between the second electrode pair and the third electrode pair is between 1-5 mm, so that the shock waves generated by them interfere with each other, thereby enhancing the shock wave energy. The enhanced shock waves generated by the first and fourth electrode pairs, and the enhanced shock waves generated by the second and third electrode pairs, are symmetrically distributed on both sides of the catheter 1, enabling more uniform application of shock waves to multiple locations along the circumference of the blood vessel.

[0087] This application provides a second optional embodiment of the above device, such as Figure 4The first discharge portion 1021 and the second discharge portion 1031 are spaced circumferentially at an angle of 120°. The first discharge portion 1021 and the fourth discharge portion 1061 are located at substantially the same circumferential position. The distance between the first electrode pair and the fourth electrode pair is between 1 and 5 mm. The second discharge portion 1031 and the third discharge portion 1051 are located at substantially the same circumferential position. The distance between the second electrode pair and the third electrode pair is between 1 and 5 mm. The shock waves generated by the first, second, third, and fourth electrode pairs interfere with each other, thereby enhancing the shock wave energy. In this embodiment, the direction of the shock waves generated by the four electrode pairs is relatively more concentrated. Compared to the shock waves enhanced by the interference of two electrode pairs in the first embodiment, the shock waves enhanced by the interference of four electrode pairs in the second embodiment have stronger energy.

[0088] In the above optional embodiment, the first discharge portion 1021 and the third discharge portion 1051 may be located at substantially the same circumferential position; the second discharge portion 1031 and the fourth discharge portion 1061 may be located at substantially the same circumferential position.

[0089] This application provides a third optional embodiment of the above device, such as Figures 5 to 8 As shown, the first discharge portion 1021 and the second discharge portion 1031 have a first circumferential gap and a second circumferential gap along the circumferential direction; Figure 7 , the circumferential angle corresponding to the first circumferential gap is 90°, and the circumferential angle corresponding to the second circumferential gap is 270°;

[0090] like Figure 8 The third discharge portion 1051 is at least partially circumferentially located in the first circumferential gap 1101, the fourth discharge portion 1061 is circumferentially located in the second circumferential gap 1102, and the fourth discharge portion 1061 is circumferentially located in the second circumferential gap 1102; the third discharge portion 1051 and the first discharge portion 1021 have a first circumferential gap 1101a along the circumference, and the third discharge portion 1051 and the second discharge portion 1031 have a first second circumferential gap 1101b along the circumference; the fourth discharge portion 1061 and the first discharge portion 1021 have a second circumferential gap 1102a along the circumference, and the fourth discharge portion 1061 and the second discharge portion 1031 have a second second circumferential gap 1102b along the circumference;

[0091] The circumferential angle corresponding to the first circumferential gap 1101a is smaller than the circumferential angle corresponding to the second circumferential gap 1102a, and the circumferential angle corresponding to the first circumferential gap 1101a is smaller than the circumferential angle corresponding to the second circumferential gap 1102b;

[0092] The circumferential angle corresponding to the first and second circumferential gaps 1101b is smaller than the circumferential angle corresponding to the second circumferential gap 1102a, and the circumferential angle corresponding to the first and second circumferential gaps 1101b is smaller than the circumferential angle corresponding to the second and second circumferential gaps 1102b.

[0093] In the third embodiment, the first electrode pair, the second electrode pair, and the third electrode pair locally generate mutually interfering shock waves. Compared to the first embodiment, in which two electrode pairs generate mutually interfering shock waves, the third embodiment can locally apply shock waves with stronger energy to the blood vessels. Furthermore, like the second embodiment, the third embodiment can also apply shock waves at two circumferential locations.

[0094] The third embodiment described above can apply shock waves at two circumferential positions. Compared with the second embodiment, the third embodiment can apply shock waves at more circumferential positions, thus avoiding the inability of shock waves to be applied to calcified plaques in blood vessels due to the concentrated direction of shock waves.

[0095] Optionally, the circumferential position of the fourth discharge portion 1061 is located at approximately the center of the second circumferential gap 1102, and the first circumferential gap 1101a and the first-second circumferential gap 1101b are 135° respectively; the circumferential position of the third discharge portion 1051 is located at approximately the center of the first circumferential gap 1101, and the second circumferential gap 1102a and the second-second circumferential gap 1102b are 45° respectively.

[0096] Optionally, the third discharge portion 1051 and the fourth discharge portion 1061 are arranged substantially symmetrically along the axis.

[0097] In a third optional embodiment, optionally, the distance between the first electrode pair and the third electrode pair is between 1-5 mm; the distance between the second electrode pair and the third electrode pair is between 1-5 mm; the shock waves generated by the first electrode pair, the second electrode pair, and the third electrode pair interfere with each other, thereby enhancing the shock wave energy. The fourth electrode pair generates independent shock waves at other circumferential positions.

[0098] Specifically, the second outer electrode sheath 104 has a second first end surface and a second second end surface in the axial direction; the third discharge portion 1051 is close to the second first end surface in the axial direction of the second outer electrode sheath 104;

[0099] An axial distance between an end surface of the first outer electrode sheath 101 close to the first discharge portion 1021 and the second end surface of the second outer electrode sheath 104 is between 1 mm and 5 mm;

[0100] An axial distance between an end surface of the first outer electrode sheath 101 close to the second discharge portion 1031 and the second first end surface of the second outer electrode sheath 104 is between 1 mm and 5 mm.

[0101] In an optional scheme of the third embodiment, the second outer electrode sheath 104 is located between the first discharge portion 1021 and the third discharge portion 1051, and the distance between the first electrode pair and the third electrode pair is greater than the axial width of the second outer electrode sheath 104; for example, if the axial width of the second outer electrode sheath 104 is 5 mm, the distance between the first electrode pair and the third electrode pair must be greater than 5 mm.

[0102] In this optional solution, the first outer electrode sheath 101 and the second outer electrode sheath 104 are located between the second discharge portion 1031 and the third discharge portion 1051, and the distance between the second electrode pair and the third electrode pair is greater than the sum of the axial width of the first outer electrode sheath 101 and the axial width of the second outer electrode sheath 104; for example, if the axial widths of the first outer electrode sheath 101 and the second outer electrode sheath 104 are both 5 mm, the distance between the second electrode pair and the third electrode pair must be greater than 10 mm.

[0103] It can be seen that in this optional scheme, since at least one of the first outer electrode sheath 101 and the second outer electrode sheath 104 is located between two axially adjacent electrode pairs, the two axially adjacent electrode pairs must be separated by a certain distance, which may affect the interference enhancement of the shock wave between the two axially adjacent electrode pairs; on the other hand, when the interference enhancement of the shock wave is generated between the two axially adjacent electrode pairs, the area between the two axially adjacent electrode pairs will generate enhanced shock wave energy, and the above-mentioned enhanced shock wave energy will generate mechanical impact on the outer electrode sheath located between the two axially adjacent electrode pairs, which may easily cause the outer electrode sheath to deform and loosen.

[0104] In another alternative of the third embodiment, as Figure 5 and Figure 6 The first discharge portion 1021 and the second discharge portion 1031 are both located in the gap between the first outer electrode sheath 101 and the second outer electrode sheath 104; the third discharge portion 1051 is located in the gap between the first outer electrode sheath 101 and the second outer electrode sheath 104.

[0105] In another optional scheme, the first electrode assembly is located at the proximal end of the second electrode assembly; the first discharge portion 1021 is located distal to the distal end face of the first outer electrode sheath 101; the second discharge portion 1031 is located distal to the distal end face of the first outer electrode sheath 101; the third discharge portion 1051 is located proximal to the proximal end face of the second outer electrode sheath 104; the first discharge portion 1021, the second discharge portion 1031, and the third discharge portion 1051 are all located in the gap between the first outer electrode sheath 101 and the second outer electrode sheath 104, and the distance between the two axially adjacent electrode pairs can be adjusted as needed; the first outer electrode sheath 101 and the second outer electrode sheath 104 will not separate the two axially adjacent electrode pairs, and will not withstand the enhanced shock wave energy in the area between the two axially adjacent electrode pairs.

[0106] In another optional solution, optionally, Figure 6 , the fourth discharge portion 1061 is located on the side of the second outer electrode sheath 104 away from the first outer electrode sheath 101, that is, on the far side of the distal end surface of the second outer electrode sheath 104; or Figure 5 The fourth discharge portion 1061 is located on a side of the second outer electrode sheath 104 close to the first outer electrode sheath 101 , that is, proximal to the proximal end surface of the second outer electrode sheath 104 . Figure 5 and Figure 6 In the figure, the fourth discharge portion 1061 is located on the back of the catheter, so the dotted line is used to indicate that it is a perspective view.

[0107] In the third embodiment, optionally, Figure 9 As shown, the device further includes a third electrode assembly; the third electrode assembly includes

[0108] a third outer electrode sheath 107 ; the third outer electrode sheath 107 is sleeved on the outer periphery of the catheter 1 ; and the second outer electrode sheath 104 is located between the third outer electrode sheath 107 and the first outer electrode sheath 101 ;

[0109] a fifth inner electrode; the fifth inner electrode comprises a fifth discharge portion 1081 and a fifth fixing portion; the fifth fixing portion is located between the outer wall of the catheter 1 and the inner wall of the third outer electrode sheath 107; the fifth discharge portion 1081 can contact the liquid in the balloon 2; the fifth inner electrode is electrically connected to the fourth inner electrode; the third outer electrode sheath 107 and the fifth inner electrode are configured to be insulated and separated;

[0110] a sixth inner electrode; the sixth inner electrode includes a sixth discharge portion 1091 and a sixth fixing portion; the sixth fixing portion is located between the outer wall of the catheter 1 and the inner wall of the third outer electrode sheath 107; the sixth discharge portion 1091 can contact the liquid in the balloon 2; the sixth discharge portion 1091 and the fifth discharge portion 1081 are arranged at intervals along the circumference of the catheter 1; the third outer electrode sheath 107 and the sixth inner electrode are configured to be insulated and separated;

[0111] When a voltage is applied between the fifth inner electrode and the sixth inner electrode, a discharge arc may be generated in the liquid between the fifth discharge portion 1081 and the third outer electrode sheath 107, and a discharge arc may be generated in the liquid between the third outer electrode sheath 107 and the sixth discharge portion 1091, allowing current to pass through the fifth discharge portion 1081, the third outer electrode sheath 107, and the sixth discharge portion 1091 in sequence.

[0112] Optionally, a voltage is applied between the first inner electrode 102 and the sixth inner electrode to allow current to pass through the first discharge portion 1021, the first outer electrode sheath 101, the second discharge portion 1031, the third discharge portion 1051, the second outer electrode sheath 104, the fourth discharge portion 1061, the fifth discharge portion 1081, the third outer electrode sheath 107, and the sixth discharge portion 1091 in sequence.

[0113] Alternatively, two power supply circuits are provided, wherein one power supply circuit applies a voltage between the first inner electrode 102 and the fourth inner electrode, and the other power supply circuit applies a voltage between the fifth inner electrode and the sixth inner electrode; the time for applying the voltage by the two power supply circuits should be the same.

[0114] The fifth discharge portion 1081 and the sixth discharge portion 1091 have a third circumferential gap and a fourth circumferential gap along the circumferential direction; the circumferential angle corresponding to the third circumferential gap is greater than 30° and less than 150°, namely, 90°; the circumferential angle corresponding to the fourth circumferential gap is greater than the circumferential angle corresponding to the third circumferential gap, namely, 270°;

[0115] The third discharge portion 1051 is circumferentially located in the fourth circumferential gap; at least a portion of the fourth discharge portion 1061 is circumferentially located in the third circumferential gap; a third circumferential gap is defined between the third discharge portion 1051 and the fifth discharge portion 1081, and a third second circumferential gap is defined between the third discharge portion 1051 and the sixth discharge portion 1091; a fourth circumferential gap is defined between the fourth discharge portion 1061 and the fifth discharge portion 1081, and a fourth second circumferential gap is defined between the fourth discharge portion 1061 and the sixth discharge portion 1091.

[0116] The circumferential angle corresponding to the third circumferential gap is greater than the circumferential angle corresponding to the fourth circumferential gap, and the circumferential angle corresponding to the third circumferential gap is greater than the circumferential angle corresponding to the fourth circumferential gap;

[0117] The circumferential angle corresponding to the third-second circumferential gap is greater than the circumferential angle corresponding to the fourth circumferential gap, and the circumferential angle corresponding to the third-second circumferential gap is greater than the circumferential angle corresponding to the fourth-second circumferential gap.

[0118] Optionally, the circumferential position of the fourth discharge portion 1061 is located at approximately the center of the third circumferential gap, and the fourth circumferential gap and the fourth-second circumferential gap are 45° respectively; the circumferential position of the third discharge portion 1051 is located at approximately the center of the fourth circumferential gap, and the third circumferential gap and the third-second circumferential gap are 135° respectively.

[0119] Specifically, the second outer electrode sheath 104 has a second first end surface and a second second end surface in the axial direction; the fourth discharge portion 1061 is close to the second second end surface in the axial direction of the second outer electrode sheath 104;

[0120] An axial distance between an end surface of the third outer electrode sheath 107 close to the fifth discharge portion 1081 and the second end surface of the second outer electrode sheath 104 is between 1 mm and 5 mm;

[0121] An axial distance between an end surface of the third outer electrode sheath 107 close to the sixth discharge portion 1091 and the second end surface of the second outer electrode sheath 104 is between 1 mm and 5 mm.

[0122] In the above optional scheme, the first electrode pair, the second electrode pair and the third electrode pair generate mutually interfering enhanced shock waves at a local position, and the fourth electrode pair, the fifth electrode pair and the sixth electrode pair generate mutually interfering enhanced shock waves at another local position; the shock waves at the two positions are both enhanced by the interference of the three electrode pairs, and the two positions have circumferential and axial spacing, and can act on multiple positions of the blood vessel.

[0123] Optionally, the fourth discharge portion 1061, the fifth discharge portion 1081, and the sixth discharge portion 1091 are all located in the gap between the second outer electrode sheath 104 and the third outer electrode sheath 107; the distance between two axially adjacent electrode pairs can be adjusted as needed; the second outer electrode sheath 104 and the third outer electrode sheath 107 will not separate the two axially adjacent electrode pairs, and will not withstand the enhanced shock wave energy in the area between the two axially adjacent electrode pairs.

[0124] In an optional embodiment of the present application, optionally, the first inner electrode, the second inner electrode, the third inner electrode, and the fourth inner electrode in the shock wave balloon catheter device are all composed of insulated wires; specifically, the shock wave balloon catheter device includes a catheter and a balloon sealed around the outer circumference of the catheter, and the balloon can be filled with liquid;

[0125] a first outer electrode sheath; the first outer electrode sheath is sleeved on the outer periphery of the catheter;

[0126] a second outer electrode sheath; the second outer electrode sheath is sleeved on the outer periphery of the catheter; and the second outer electrode sheath and the first outer electrode sheath are spaced apart in the axial direction;

[0127] a first insulated wire; a portion of the first insulated wire is crimped between the outer wall of the catheter and the inner wall of the first outer electrode sheath; the first insulated wire passes through the wire's insulation layer, so that the conductor of the wire and the first outer electrode sheath are insulated; a portion of the insulation layer of the first insulated wire is removed to form a first discharge portion; the first discharge portion can contact the liquid in the balloon; the first discharge portion is located in the gap between the first outer electrode sheath and the second outer electrode sheath;

[0128] a second insulated conductor; a portion of the second insulated conductor is crimped between the outer wall of the catheter and the inner wall of the first outer electrode sheath, and another portion of the second insulated conductor is crimped between the outer wall of the catheter and the inner wall of the second outer electrode sheath; a portion of the insulation layer of the second insulated conductor is removed to form a second discharge portion, and another portion of the insulation layer of the second insulated conductor is removed to form a third discharge portion; both the second discharge portion and the third discharge portion can contact the liquid in the balloon; both the second discharge portion and the third discharge portion are located in the gap between the first outer electrode sheath and the second outer electrode sheath;

[0129] a third insulated conductor; a portion of the third insulated conductor is crimped between the outer wall of the catheter and the inner wall of the second outer electrode sheath; a portion of the insulation layer of the third insulated conductor is removed to form a fourth discharge portion; the fourth discharge portion can contact the liquid in the balloon; the fourth discharge portion is located in the gap between the first outer electrode sheath and the second outer electrode sheath;

[0130] When a voltage is applied between the first insulated wire and the third insulated wire, a discharge arc may be generated in the liquid between the first discharge portion and the first outer electrode sheath, a discharge arc may be generated in the liquid between the first outer electrode sheath and the second discharge portion, a discharge arc may be generated in the liquid between the third discharge portion and the second outer electrode sheath, and a discharge arc may be generated in the liquid between the second outer electrode sheath and the fourth discharge portion; so as to allow current to pass through the first discharge portion, the first outer electrode sheath, the second discharge portion, the third discharge portion, the second outer electrode sheath, and the fourth discharge portion in sequence.

[0131] In the optional embodiment of the present application, optionally, as Figure 10 The first inner electrode 203, the second inner electrode 204, the third inner electrode 207, and the fourth inner electrode 208 are all in the shape of arc plates; and the inner walls of the first inner electrode 203, the second inner electrode 204, the third inner electrode 207, and the fourth inner electrode 208 are all attached to the outer wall of the catheter;

[0132] The first electrode assembly further includes a first insulating sheath 202; the first insulating sheath 202 is located between the first outer electrode sheath 201 and the first inner electrode 203, and is used to insulate and separate the first outer electrode sheath 201 and the first inner electrode 203; and the first insulating sheath 202 is located between the first outer electrode sheath 201 and the second inner electrode 204, and is used to insulate and separate the first outer electrode sheath 201 and the second inner electrode 204;

[0133] The second electrode assembly also includes a second insulating sheath 206; the second insulating sheath 206 is located between the second outer electrode sheath 205 and the third inner electrode 207, and is used to insulate and separate the second outer electrode sheath 205 and the third inner electrode 207; and the second insulating sheath 206 is located between the second outer electrode sheath 205 and the fourth inner electrode 208, and is used to insulate and separate the second outer electrode sheath 205 and the fourth inner electrode 208.

[0134] In this embodiment, the optional arc angle corresponding to the first inner electrode 203 is 30° to 120°; the arc angle corresponding to the second inner electrode 204 is 30° to 120°; the arc angle corresponding to the third inner electrode 207 is 30° to 120°; and the arc angle corresponding to the fourth inner electrode 208 is 30° to 120°.

[0135] The first inner electrode 203 , the second inner electrode 204 , the third inner electrode 207 , and the fourth inner electrode 208 are all in the shape of arc plates, so that the discharge position of each electrode pair is random, and shock waves can be applied to more positions on the circumference of the blood vessel.

[0136] In the embodiment of the present application, the circumferential spacing angle between the discharge portions may be the circumferential spacing angle between the geometric centers of the discharge portions, or may be the spacing angle between adjacent circumferential end faces of the discharge portions.

[0137] It should be noted that, in the description of this specification, the terms "first," "second," etc., are used solely for descriptive purposes and to distinguish similar objects. There is no order of precedence between the two, nor should they be understood to indicate or imply relative importance. Furthermore, in the description of this specification, unless otherwise specified, "plurality" means two or more.

[0138] The above embodiments are intended only to illustrate the technical concepts and features of this application. Their purpose is to enable those familiar with the art to understand the content of this application and implement it accordingly. They are not intended to limit the scope of protection of this application. Any equivalent changes or modifications made in accordance with the spirit of this application shall be included in the scope of protection of this application.

[0139] It should be understood that the above description is for illustration and not for limitation. Many embodiments and applications beyond the examples provided will be apparent to those skilled in the art upon reading the above description. For comprehensive purposes, all articles and references, including disclosures of patent applications and publications, are incorporated herein by reference.

Claims

1. A shock wave balloon catheter device comprising a catheter, a balloon sealed around the outer periphery of the catheter, a first electrode assembly and a second electrode assembly disposed within the balloon, wherein the balloon can be filled with a liquid; The first electrode assembly includes a first outer electrode sheath; the first outer electrode sheath is sleeved on the outer periphery of the catheter; a first inner electrode; the first inner electrode comprises a first discharge portion and a first fixing portion; the first fixing portion is located between the outer wall of the catheter and the inner wall of the first outer electrode sheath; the first discharge portion can contact the liquid in the balloon; the first outer electrode sheath and the first inner electrode are configured to be insulated and separated; a second inner electrode; the second inner electrode includes a second discharge portion and a second fixing portion; the second fixing portion is located between the outer wall of the catheter and the inner wall of the first outer electrode sheath; the second discharge portion can contact the liquid in the balloon; the second discharge portion and the first discharge portion are arranged at intervals along the circumference of the catheter; the first outer electrode sheath and the second inner electrode are configured to be insulated and separated; The second electrode assembly includes a second outer electrode sheath; the second outer electrode sheath is sleeved on the outer periphery of the catheter; and the second outer electrode sheath and the first outer electrode sheath are spaced apart in the axial direction; a third inner electrode; the third inner electrode comprises a third discharge portion and a third fixing portion; the third fixing portion is located between the outer wall of the catheter and the inner wall of the second outer electrode sheath; the third discharge portion can contact the liquid in the balloon; the third inner electrode is electrically connected to the second inner electrode; the second outer electrode sheath and the third inner electrode are configured to be insulated and separated; a fourth inner electrode; the fourth inner electrode comprising a fourth discharge portion and a fourth fixing portion; the fourth fixing portion being located between the outer wall of the catheter and the inner wall of the second outer electrode sheath; the fourth discharge portion being capable of contacting the liquid within the balloon; the fourth discharge portion and the third discharge portion being spaced apart along the circumference of the catheter; and the second outer electrode sheath and the fourth inner electrode being configured to be insulated and separated; When a voltage is applied between the first inner electrode and the fourth inner electrode, a discharge arc may be generated in the liquid between the first discharge portion and the first outer electrode sheath, a discharge arc may be generated in the liquid between the first outer electrode sheath and the second discharge portion, a discharge arc may be generated in the liquid between the third discharge portion and the second outer electrode sheath, and a discharge arc may be generated in the liquid between the second outer electrode sheath and the fourth discharge portion; to allow current to sequentially pass through the first discharge portion, the first outer electrode sheath, the second discharge portion, the third discharge portion, the second outer electrode sheath, and the fourth discharge portion; Its characteristics are: The first discharge portion and the second discharge portion have a first circumferential gap and a second circumferential gap along the circumferential direction; the circumferential angle corresponding to the first circumferential gap is greater than 30° and less than 150°; the circumferential angle corresponding to the second circumferential gap is greater than the circumferential angle corresponding to the first circumferential gap; Among the third discharge portion and the fourth discharge portion, at least a portion of the circumferential position of one discharge portion is located in the first circumferential gap, and the circumferential position of the other discharge portion is located in the second circumferential gap; a first circumferential gap is formed between the one discharge portion and the first discharge portion along the circumference, and a first second circumferential gap is formed between the one discharge portion and the second discharge portion along the circumference; There is a second circumferential gap between the other discharge portion and the first discharge portion, and there is a second second circumferential gap between the other discharge portion and the second discharge portion. The circumferential angle corresponding to the first circumferential gap is smaller than the circumferential angle corresponding to the second circumferential gap, and the circumferential angle corresponding to the first circumferential gap is smaller than the circumferential angle corresponding to the second circumferential gap; The circumferential angle corresponding to the first two circumferential gaps is smaller than the circumferential angle corresponding to the second circumferential gap, and the circumferential angle corresponding to the first two circumferential gaps is smaller than the circumferential angle corresponding to the second two circumferential gaps.

2. The device according to claim 1, wherein: Of the third discharge portion and the fourth discharge portion, the other discharge portion is located approximately at the center of the second circumferential gap in the circumferential direction.

3. The device according to claim 2, characterized in that: A circumferential position of one of the third discharge portion and the fourth discharge portion is located approximately at a center position of the first circumferential gap.

4. The device according to claim 1, wherein: The first discharge portion and the second discharge portion are both located in the gap between the first outer electrode sheath and the second outer electrode sheath; At least a portion of the circumferential position of one of the third discharge portion and the fourth discharge portion is located in the first circumferential gap, and the one discharge portion is located in the gap between the first outer electrode sheath and the second outer electrode sheath.

5. The device according to claim 1, wherein: The first discharge portion and the second discharge portion are both located in the gap between the first outer electrode sheath and the second outer electrode sheath; The circumferential position of the other of the third discharge portion and the fourth discharge portion is located in the second circumferential gap, and the other discharge portion is located on a side of the second outer electrode sheath away from the first outer electrode sheath.

6. The device according to any one of claims 1 to 5, characterized in that: The second outer electrode sheath has a second first end surface and a second second end surface in the axial direction; at least a portion of the circumferential position of one of the third discharge portion and the fourth discharge portion is located in the first circumferential gap, and the one discharge portion is close to the second first end surface in the axial direction of the second outer electrode sheath; An axial distance between an end surface of the first outer electrode sheath close to the first discharge portion and the second end surface of the second outer electrode sheath is between 1 mm and 5 mm; An axial distance between an end surface of the first outer electrode sheath close to the second discharge portion and the second first end surface of the second outer electrode sheath is between 1 mm and 5 mm.

7. The device according to claim 1, wherein: The device further comprises a third electrode assembly; the third electrode assembly comprises a third outer electrode sheath; the third outer electrode sheath is sleeved on the outer periphery of the catheter; and the second outer electrode sheath is located between the third outer electrode sheath and the first outer electrode sheath; a fifth inner electrode; the fifth inner electrode comprising a fifth discharge portion and a fifth fixing portion; the fifth fixing portion being located between the outer wall of the catheter and the inner wall of the third outer electrode sheath; the fifth discharge portion being capable of contacting the liquid within the balloon; the fifth inner electrode being electrically connected to the fourth inner electrode; and the third outer electrode sheath being configured to be insulated and separated from the fifth inner electrode; a sixth inner electrode; the sixth inner electrode comprising a sixth discharge portion and a sixth fixing portion; the sixth fixing portion being located between the outer wall of the catheter and the inner wall of the third outer electrode sheath; the sixth discharge portion being capable of contacting the liquid within the balloon; the sixth discharge portion and the fifth discharge portion being spaced apart along the circumference of the catheter; the third outer electrode sheath and the sixth inner electrode being configured to be insulated and separated; When a voltage is applied between the fifth inner electrode and the sixth inner electrode, a discharge arc may be generated in the liquid between the fifth discharge portion and the third outer electrode sheath, and a discharge arc may be generated in the liquid between the third outer electrode sheath and the sixth discharge portion; to allow current to sequentially pass through the fifth discharge portion, the third outer electrode sheath, and the sixth discharge portion; The fifth discharge portion and the sixth discharge portion have a third circumferential gap and a fourth circumferential gap along the circumferential direction; the circumferential angle corresponding to the third circumferential gap is greater than 30° and less than 150°; the circumferential angle corresponding to the fourth circumferential gap is greater than the circumferential angle corresponding to the third circumferential gap; Among the third discharge portion and the fourth discharge portion, at least a portion of the circumferential position of one discharge portion is located in the first circumferential gap, and the circumferential position of the one discharge portion is located in the fourth circumferential gap; the circumferential position of the other discharge portion is located in the second circumferential gap, and at least a portion of the circumferential position of the other discharge portion is located in the third circumferential gap; the one discharge portion and the fifth discharge portion have a third circumferential gap along the circumference, and the one discharge portion and the sixth discharge portion have a third second circumferential gap along the circumference; the other discharge portion and the fifth discharge portion have a fourth circumferential gap along the circumference, and the other discharge portion and the sixth discharge portion have a fourth second circumferential gap along the circumference; The circumferential angle corresponding to the third circumferential gap is greater than the circumferential angle corresponding to the fourth circumferential gap, and the circumferential angle corresponding to the third circumferential gap is greater than the circumferential angle corresponding to the fourth circumferential gap; The circumferential angle corresponding to the third-second circumferential gap is greater than the circumferential angle corresponding to the fourth circumferential gap, and the circumferential angle corresponding to the third-second circumferential gap is greater than the circumferential angle corresponding to the fourth-second circumferential gap.

8. The device according to claim 7, characterized in that: Of the third discharge portion and the fourth discharge portion, the other discharge portion is located approximately at the center of the third circumferential gap in the circumferential direction.

9. The device according to claim 7, wherein: The circumferential position of one of the third discharge portion and the fourth discharge portion is approximately at the center of the fourth circumferential gap.

10. The device according to claim 7, wherein: The fifth discharge portion and the sixth discharge portion are both located in the gap between the second outer electrode sheath and the third outer electrode sheath; At least a portion of the circumferential position of the other of the third discharge portion and the fourth discharge portion is located in the third circumferential gap, and the other discharge portion is located in the gap between the second outer electrode sheath and the third outer electrode sheath.

11. The device according to any one of claims 7 to 10, characterized in that: The second outer electrode sheath has a second first end surface and a second second end surface in the axial direction; at least a portion of the circumferential position of the other of the third discharge portion and the fourth discharge portion is located in the third circumferential gap, and the other discharge portion is close to the second second end surface in the axial direction of the second outer electrode sheath; An axial distance between an end surface of the third outer electrode sheath close to the fifth discharge portion and the second second end surface of the second outer electrode sheath is between 1 mm and 5 mm; An axial distance between an end surface of the third outer electrode sheath close to the sixth discharge portion and the second second end surface of the second outer electrode sheath is between 1 mm and 5 mm.

12. The device according to claim 1, wherein: The first internal electrode constitutes a first insulated wire, and a portion of the insulation layer of the first insulated wire is removed to form the first discharge portion; The second inner electrode and the third inner electrode constitute a second insulated wire, a portion of the insulation layer of the second insulated wire is removed to form the second discharge portion, and another portion of the insulation layer of the second insulated wire is removed to form the third discharge portion; The third internal electrode constitutes a third insulated conductive line, and a portion of the insulating layer of the third insulated conductive line is removed to constitute the fourth discharge portion.

13. The device according to claim 1, wherein: The first inner electrode, the second inner electrode, the third inner electrode, and the fourth inner electrode are all in the shape of arc plates; and the inner walls of the first inner electrode, the second inner electrode, the third inner electrode, and the fourth inner electrode are all attached to the outer wall of the catheter; The first electrode assembly further includes a first insulating sheath; the first insulating sheath is located between the first outer electrode sheath and the first inner electrode, and is used to insulate and separate the first outer electrode sheath and the first inner electrode; and the first insulating sheath is located between the first outer electrode sheath and the second inner electrode, and is used to insulate and separate the first outer electrode sheath and the second inner electrode; The second electrode assembly also includes a second insulating sheath; the second insulating sheath is located between the second outer electrode sheath and the third inner electrode, and is used to insulate and separate the second outer electrode sheath and the third inner electrode; and the second insulating sheath is located between the second outer electrode sheath and the fourth inner electrode, and is used to insulate and separate the second outer electrode sheath and the fourth inner electrode.

14. The device according to claim 13, wherein: The arc angle corresponding to the first inner electrode is 30° to 120°; the arc angle corresponding to the second inner electrode is 30° to 120°; the arc angle corresponding to the third inner electrode is 30° to 120°; and the arc angle corresponding to the fourth inner electrode is 30° to 120°.

15. A shock wave balloon catheter device comprising a catheter, a balloon sealed around the outer circumference of the catheter, a first electrode assembly and a second electrode assembly disposed within the balloon, wherein the balloon can be filled with a liquid; The first electrode assembly includes a first outer electrode sheath; the first outer electrode sheath is sleeved on the outer periphery of the catheter; a first inner electrode; the first inner electrode comprises a first discharge portion and a first fixing portion; the first fixing portion is located between the outer wall of the catheter and the inner wall of the first outer electrode sheath; the first discharge portion can contact the liquid in the balloon; the first outer electrode sheath and the first inner electrode are configured to be insulated and separated; a second inner electrode; the second inner electrode includes a second discharge portion and a second fixing portion; the second fixing portion is located between the outer wall of the catheter and the inner wall of the first outer electrode sheath; the second discharge portion can contact the liquid in the balloon; the second discharge portion and the first discharge portion are arranged at intervals along the circumference of the catheter; the first outer electrode sheath and the second inner electrode are configured to be insulated and separated; The second electrode assembly includes a second outer electrode sheath; the second outer electrode sheath is sleeved on the outer periphery of the catheter; and the second outer electrode sheath and the first outer electrode sheath are spaced apart in the axial direction; a third inner electrode; the third inner electrode comprises a third discharge portion and a third fixing portion; the third fixing portion is located between the outer wall of the catheter and the inner wall of the second outer electrode sheath; the third discharge portion can contact the liquid in the balloon; the third inner electrode is electrically connected to the second inner electrode; the second outer electrode sheath and the third inner electrode are configured to be insulated and separated; a fourth inner electrode; the fourth inner electrode comprising a fourth discharge portion and a fourth fixing portion; the fourth fixing portion being located between the outer wall of the catheter and the inner wall of the second outer electrode sheath; the fourth discharge portion being capable of contacting the liquid within the balloon; the fourth discharge portion and the third discharge portion being spaced apart along the circumference of the catheter; and the second outer electrode sheath and the fourth inner electrode being configured to be insulated and separated; When a voltage is applied between the first inner electrode and the fourth inner electrode, a discharge arc may be generated in the liquid between the first discharge portion and the first outer electrode sheath, a discharge arc may be generated in the liquid between the first outer electrode sheath and the second discharge portion, a discharge arc may be generated in the liquid between the third discharge portion and the second outer electrode sheath, and a discharge arc may be generated in the liquid between the second outer electrode sheath and the fourth discharge portion; to allow current to sequentially pass through the first discharge portion, the first outer electrode sheath, the second discharge portion, the third discharge portion, the second outer electrode sheath, and the fourth discharge portion; Its characteristics are: The first discharge portion and the second discharge portion have a first circumferential gap along the circumference; the circumferential angle corresponding to the first circumferential gap is greater than 30° and less than 150° The third discharge portion and the fourth discharge portion are substantially symmetrically arranged along the axis; and at least a portion of a circumferential position of one of the third discharge portion and the fourth discharge portion is located within the first circumferential gap.

16. A shock wave balloon catheter device comprising a catheter, a balloon sealed around the outer periphery of the catheter, a first electrode assembly and a second electrode assembly disposed within the balloon, wherein the balloon can be filled with a liquid; The first electrode assembly includes a first outer electrode sheath; the first outer electrode sheath is sleeved on the outer periphery of the catheter; a first inner electrode; the first inner electrode comprises a first discharge portion and a first fixing portion; the first fixing portion is located between the outer wall of the catheter and the inner wall of the first outer electrode sheath; the first discharge portion can contact the liquid in the balloon; the first outer electrode sheath and the first inner electrode are configured to be insulated and separated; a second inner electrode; the second inner electrode includes a second discharge portion and a second fixing portion; the second fixing portion is located between the outer wall of the catheter and the inner wall of the first outer electrode sheath; the second discharge portion can contact the liquid in the balloon; the second discharge portion and the first discharge portion are arranged at intervals along the circumference of the catheter; the first outer electrode sheath and the second inner electrode are configured to be insulated and separated; The second electrode assembly includes a second outer electrode sheath; the second outer electrode sheath is sleeved on the outer periphery of the catheter; and the second outer electrode sheath and the first outer electrode sheath are spaced apart in the axial direction; a third inner electrode; the third inner electrode comprises a third discharge portion and a third fixing portion; the third fixing portion is located between the outer wall of the catheter and the inner wall of the second outer electrode sheath; the third discharge portion can contact the liquid in the balloon; the third inner electrode is electrically connected to the second inner electrode; the second outer electrode sheath and the third inner electrode are configured to be insulated and separated; a fourth inner electrode; the fourth inner electrode comprising a fourth discharge portion and a fourth fixing portion; the fourth fixing portion being located between the outer wall of the catheter and the inner wall of the second outer electrode sheath; the fourth discharge portion being capable of contacting the liquid within the balloon; the fourth discharge portion and the third discharge portion being spaced apart along the circumference of the catheter; and the second outer electrode sheath and the fourth inner electrode being configured to be insulated and separated; When a voltage is applied between the first inner electrode and the fourth inner electrode, a discharge arc may be generated in the liquid between the first discharge portion and the first outer electrode sheath, a discharge arc may be generated in the liquid between the first outer electrode sheath and the second discharge portion, a discharge arc may be generated in the liquid between the third discharge portion and the second outer electrode sheath, and a discharge arc may be generated in the liquid between the second outer electrode sheath and the fourth discharge portion; to allow current to sequentially pass through the first discharge portion, the first outer electrode sheath, the second discharge portion, the third discharge portion, the second outer electrode sheath, and the fourth discharge portion; Its characteristics are: The first discharge portion and the second discharge portion have a first circumferential gap and a second circumferential gap along the circumferential direction; the circumferential angle corresponding to the first circumferential gap is greater than 30° and less than 150°; the circumferential angle corresponding to the second circumferential gap is greater than the circumferential angle corresponding to the first circumferential gap; Among the third discharge portion and the fourth discharge portion, at least a portion of the circumferential position of one discharge portion is located in the first circumferential gap, and the circumferential position of the other discharge portion is located approximately at the center of the second circumferential gap.

17. A shock wave balloon catheter device comprising a catheter and a balloon sealed around the outer circumference of the catheter, wherein the balloon can be filled with a liquid; a first outer electrode sheath; the first outer electrode sheath is sleeved on the outer periphery of the catheter; a second outer electrode sheath; the second outer electrode sheath being sleeved on the outer periphery of the catheter; The second outer electrode sheath and the first outer electrode sheath are spaced apart from each other in the axial direction; a first insulated wire; a portion of the first insulated wire is crimped between the outer wall of the catheter and the inner wall of the first outer electrode sheath; a portion of the insulation layer of the first insulated wire is removed to form a first discharge portion; the first discharge portion can contact the liquid in the balloon; a second insulated conductor; a portion of the second insulated conductor is crimped between the outer wall of the catheter and the inner wall of the first outer electrode sheath, and another portion of the second insulated conductor is crimped between the outer wall of the catheter and the inner wall of the second outer electrode sheath; a portion of the insulation layer of the second insulated conductor is removed to form a second discharge portion, and another portion of the insulation layer of the second insulated conductor is removed to form a third discharge portion; both the second discharge portion and the third discharge portion can contact the liquid in the balloon; a third insulated wire; a portion of the third insulated wire is crimped between the outer wall of the catheter and the inner wall of the second outer electrode sheath; a portion of the insulation layer of the third insulated wire is removed to form a fourth discharge portion; the fourth discharge portion can contact the liquid in the balloon; When a voltage is applied between the first insulated wire and the third insulated wire, a discharge arc may be generated in the liquid between the first discharge portion and the first outer electrode sheath, a discharge arc may be generated in the liquid between the first outer electrode sheath and the second discharge portion, a discharge arc may be generated in the liquid between the third discharge portion and the second outer electrode sheath, and a discharge arc may be generated in the liquid between the second outer electrode sheath and the fourth discharge portion; to allow current to sequentially pass through the first discharge portion, the first outer electrode sheath, the second discharge portion, the third discharge portion, the second outer electrode sheath, and the fourth discharge portion; Its characteristics are: The first discharge portion and the second discharge portion have a first circumferential gap and a second circumferential gap along the circumferential direction; the circumferential angle corresponding to the first circumferential gap is greater than 30° and less than 150°; the circumferential angle corresponding to the second circumferential gap is greater than the circumferential angle corresponding to the first circumferential gap; Among the third discharge portion and the fourth discharge portion, at least a portion of the circumferential position of one discharge portion is located in the first circumferential gap, and the circumferential position of the other discharge portion is located in the second circumferential gap; a first circumferential gap is formed between the one discharge portion and the first discharge portion along the circumference, and a first second circumferential gap is formed between the one discharge portion and the second discharge portion along the circumference; There is a second circumferential gap between the other discharge portion and the first discharge portion, and there is a second second circumferential gap between the other discharge portion and the second discharge portion. The circumferential angle corresponding to the first circumferential gap is smaller than the circumferential angle corresponding to the second circumferential gap, and the circumferential angle corresponding to the first circumferential gap is smaller than the circumferential angle corresponding to the second-second circumferential gap; the circumferential angle corresponding to the first-second circumferential gap is smaller than the circumferential angle corresponding to the second circumferential gap, and the circumferential angle corresponding to the first-second circumferential gap is smaller than the circumferential angle corresponding to the second-second circumferential gap.