Shockwave balloon catheter device

Abstract

A shockwave balloon catheter device, which comprises a balloon (2), electrode assemblies (3) arranged in the balloon (2), and positioning sheaths (4) wrapped around the peripheries of the electrode assemblies (3), wherein each electrode assembly (3) comprises a first electrode (301), an intermediate electrode unit and a second electrode (303) which are sequentially arranged at intervals in the circumferential direction of a catheter (1); the first electrode (301), the intermediate electrode unit and the second electrode (303) each comprise a discharge portion; each discharge portion is located outside of the axial coverage range of each positioning sheath (4) and can come into contact with a liquid in the balloon (2); and when a voltage is applied between the first electrode (301) and the second electrode (303), the discharge portion of the first electrode (301) and the discharge portion of the intermediate electrode unit can form discharge arcs in the liquid, and the discharge portion of the intermediate electrode unit and the discharge portion of the second electrode (303) can form discharge arcs in the liquid, so as to allow a current to sequentially pass through the first electrode (301), the intermediate electrode unit and the second electrode (303). It is not necessary to provide holes in the positioning sheaths (4); thus, the shockwave balloon catheter device has good integrity and stability, does not easily deform or get damaged, and has a long service life.

Description

Shock wave balloon catheter device 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 an optional embodiment, the first and second electrodes are radially stacked on the catheter. To prevent short circuits between the first and second electrodes, an insulating layer is stacked between the first and second electrodes. Furthermore, holes are provided in the second electrode and the insulating layer to allow the first electrode to be exposed and contact the fluid within the balloon. The holes in the second electrode and the insulating layer reduce their strength, making them susceptible to deformation and damage, thereby reducing the product's service life.

[0004] Summary of the Invention

[0005] The embodiments of the present application provide a shock wave balloon catheter device with a long product life.

[0006] 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, and an electrode assembly disposed within the balloon, wherein the balloon can be filled with a liquid; the electrode assembly comprises a first electrode, an intermediate electrode unit, and a second electrode; the first electrode, the intermediate electrode unit, and the second electrode are sequentially spaced apart along the circumference of the catheter;

[0007] The device further includes a positioning sheath wrapped around the periphery of the electrode assembly;

[0008] The first electrode, the intermediate electrode unit, and the second electrode each include a discharge portion; each of the discharge portions is located outside the axial coverage area of ​​the positioning sheath, and each of the discharge portions can contact the liquid in the balloon;

[0009] When a voltage is applied between the first electrode and the second electrode, the discharge portion of the first electrode and the discharge portion of the intermediate electrode unit are configured to form a discharge arc in the liquid, and the discharge portion of the intermediate electrode unit and the discharge portion of the second electrode are configured to form a discharge arc in the liquid; so as to allow current to pass through the first electrode, the intermediate electrode unit, and the second electrode in sequence.

[0010] In the embodiment provided by the present application, the discharge parts of the first electrode, the intermediate electrode unit and the second electrode are all located outside the axial coverage range of the positioning sleeve, so the positioning sleeve does not need to have a hole, so that the positioning sleeve has good integrity and stability, is not easy to deform and damage, and has a long product service life. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] 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.

[0012] FIG1 is a schematic structural diagram of a shock wave balloon catheter device provided by one embodiment of the present application;

[0013] FIG2 is a schematic structural diagram of a cross section of an electrode assembly provided by one embodiment of the present application;

[0014] FIG3 is an axonometric view of an electrode assembly provided in one embodiment of the present application;

[0015] FIG4 is an isometric perspective view of an electrode assembly provided in one embodiment of the present application;

[0016] FIG5 is an axonometric view of an electrode assembly provided in another embodiment of the present application;

[0017] FIG6 is an axonometric view of an electrode assembly provided in accordance with an embodiment of the present application. DETAILED DESCRIPTION

[0018] 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.

[0019] 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 at the same time.

[0020] The shock wave balloon catheter device according to the embodiment of this specification will be explained and described below with reference to Figures 1 to 6. It should be noted that, in the embodiments of the present invention, identical reference numerals denote identical components. For the sake of brevity, detailed descriptions of identical components will be omitted in different embodiments, and descriptions of identical components may be cross-referenced and referenced.

[0021] 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.

[0022] The shock wave balloon catheter device is indicated for interventional treatment of vascular calcifications. It 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, generating bubbles within the liquid. These bubbles expand and collapse, subsequently generating mechanical shock waves within the balloon. These shock waves are mechanically transmitted through the liquid and balloon to apply mechanical force or pressure to disrupt any calcified plaque on or in the walls of the vascular system.

[0023] 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.

[0024] 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.

[0025] In the above-mentioned shock wave balloon catheter device, the balloon is carried by the catheter and moves in the blood vessels. In some cases, the blood vessels have already suffered severe stenosis or even complete occlusion. Therefore, it is necessary to minimize the cross-sectional area of ​​the catheter and improve the flexibility of the catheter to ensure good permeability in the blood vessels.

[0026] In an optional embodiment, the first electrode and the second electrode are radially stacked on the catheter, and in order to prevent the first electrode and the second electrode from short-circuiting, an insulating medium layer is stacked between the first electrode and the second electrode; and holes are also required in the second electrode and the insulating medium layer so that the first electrode can be exposed and contact the liquid in the balloon.

[0027] This design, with two layers of electrodes and one insulating dielectric layer stacked on the outer wall of the catheter, results in a large cross-sectional area at the location of the electrodes, resulting in poor flexibility and difficulty in passing through vessels with severe stenosis or complete occlusion. Furthermore, the openings in the second electrode and the insulating dielectric layer reduce their strength, making them susceptible to deformation and damage.

[0028] An optional embodiment of the shock wave balloon catheter device provided herein, as shown in FIG1 , comprises a catheter 1, a balloon 2 sealed around the outer periphery of the catheter 1, and at least one electrode assembly 3 disposed within the balloon 2; the balloon 2 can be filled with a liquid. The liquid includes, but is not limited to, water, saline, a contrast agent, and mixtures thereof.

[0029] Optionally, in this embodiment, the number of the electrode assemblies 3 is at least 2, and at least 2 of the electrode assemblies 3 are arranged at intervals along the axial direction of the catheter 1, so that discharge shock waves are generated at multiple positions in the balloon 2, thereby more efficiently destroying the calcified area.

[0030] The electrode assembly includes a first electrode 301 , an intermediate electrode unit, and a second electrode 303 ; the first electrode 301 , the intermediate electrode unit, and the second electrode 303 are sequentially spaced apart along the circumference of the catheter 1 .

[0031] Specifically, the intermediate electrode unit includes a first intermediate electrode, a second intermediate electrode, ..., and an Nth intermediate electrode, where N ≥ 1; the first electrode, the first intermediate electrode, the second intermediate electrode, ..., the Nth intermediate electrode, and the second electrode are sequentially spaced apart along the circumference of the catheter. In this embodiment, the first, second, ..., and Nth intermediate electrodes are defined as a continuous natural number sequence, used to describe the naming of multiple intermediate electrodes when multiple intermediate electrodes are provided; therefore, embodiments in which the intermediate electrode unit has only one first intermediate electrode are not excluded.

[0032] In this embodiment, the first intermediate electrode, the second intermediate electrode, ..., the Nth intermediate electrode are neither grounded through a wire nor connected to a power source through a wire.

[0033] In the embodiment shown in Figure 2, the intermediate electrode unit includes a first intermediate electrode 302; each electrode assembly 3 includes a first electrode 301, a first intermediate electrode 302, and a second electrode 303. The first electrode 301, the first intermediate electrode 302, and the second electrode 303 are spaced apart along the circumference of the catheter 1. Optionally, the cross-sections of the first electrode 301, the first intermediate electrode 302, and the second electrode 303 are all arc-shaped, with the inner walls of the first electrode 301 and the inner walls of the first intermediate electrode 302 respectively affixed to the outer wall of the catheter 1, thereby ensuring a more stable connection and reducing the cross-sectional dimensions. The first electrode 301, the first intermediate electrode 302, and the second electrode 303 are spaced apart in sequence along the circumference of the catheter 1.

[0034] It is understood that the number of intermediate electrodes in the intermediate electrode unit is not limited to this embodiment. For example, if N = 2, each electrode assembly 3 includes a first electrode 301, a first intermediate electrode 302, a second intermediate electrode, and a second electrode 303. The first electrodes 301, 302, 303 are spaced apart along the circumference of the catheter 1. The first electrode 301 and the first intermediate electrode 302 form an electrode pair; the first intermediate electrode 302 and the second intermediate electrode form an electrode pair; and the second intermediate electrode and the second electrode 303 form an electrode pair. When a voltage is applied between the first electrode 301 and the second electrode 303, the electrode pairs are configured to form discharge arcs in the liquid, allowing current to flow through the first electrode 301, the first intermediate electrode 302, the second intermediate electrode, and the second electrode 303 in sequence.

[0035] The arc angles of the arc-shaped first electrode 301, first intermediate electrode 302, and second electrode 303 can be the same or different. For example, the arc angles of the first electrode 301, first intermediate electrode 302, and second electrode 303 are all 100°; or the arc angle of the first electrode 301 is 120°, and the arc angles of the first intermediate electrode 302 and second electrode 303 are 100°.

[0036] The lengths of the first electrode 301 , the first intermediate electrode 302 and the second electrode 303 along the axial direction of the catheter 1 may be the same or different; they only need to be at least partially located in the same interval in the axial direction.

[0037] When the first electrode 301 is adjacent to the second electrode 303, optionally, the distance between the first electrode 301 and the second electrode 303 is configured such that, when a voltage is applied between the first electrode 301 and the second electrode 303, no discharge arc is formed between the first electrode 301 and the second electrode 303. For example, the arc angles of the first electrode 301, the first intermediate electrode 302, and the second electrode 303 are all 100°, and the central angle corresponding to the two gaps 305 is 5°, which is small enough to form a discharge shock wave. Therefore, the central angle between the first electrode 301 and the second electrode 303 is 50°. Due to the large distance between the first electrode 301 and the second electrode 303, no discharge arc is formed between the first electrode 301 and the second electrode 303.

[0038] When the first electrode 301 is adjacent to the second electrode 303, an insulating shielding medium is optionally provided between the first electrode 301 and the second electrode 303. The insulating shielding medium is configured to fill the entire area between the first electrode 301 and the second electrode 303, so that no liquid is present between the first electrode 301 and the second electrode 303. Therefore, when a voltage is applied between the first electrode 301 and the second electrode, no discharge arc is formed between the first electrode 301 and the second electrode 303.

[0039] As the electrode assembly 3 follows the catheter 1 in the movement of the human body's blood vessels and during the discharge process, the electrode assembly 3 will bend with the catheter 1 and be subject to the resistance exerted by the blood vessels and mechanical vibrations, which may cause the electrode assembly 3 to be displaced relative to the catheter 1 or even fall off the catheter 1. Therefore, in an optional embodiment of the present application, the shock wave balloon catheter device further includes a positioning sheath 4 disposed on the periphery of the electrode assembly 3.

[0040] Optionally, the positioning sheath 4 is made of insulating material through thermoplastic molding.

[0041] Alternatively, the positioning sheath 4 includes a metal inner core and a sheath insulation layer; the sheath insulation layer wraps around the outer surface of the metal inner core to maintain insulation between the metal inner core and the electrode assembly; the sheath insulation layer can specifically be an insulating coating applied to the outer surface of the metal inner core. Positioning sheaths 4 made of this material are stronger and less susceptible to deformation and damage.

[0042] The positioning sheath 4 wraps and fixes the electrode assembly 3 on the catheter 1, which can effectively prevent the electrode assembly 3 from falling off the catheter 1 due to various factors during the operation, and the electrode assembly 3 from being displaced relative to the catheter 1, thereby improving the safety and reliability of the device.

[0043] In the optional embodiments shown in FIG3 and FIG4 , the first electrode 301, the first intermediate electrode 302, and the second electrode 303 each include a discharge portion; each of the discharge portions is located outside the axial coverage area of ​​the positioning sheath 4, and each of the discharge portions can contact the liquid in the balloon 2;

[0044] When a voltage is applied between the first electrode 301 and the second electrode 303, the discharge portion of the first electrode 301 and the discharge portion of the first intermediate electrode 302 are configured to form a discharge arc in the liquid, and the discharge portion of the first intermediate electrode 302 and the discharge portion of the second electrode 303 are configured to form a discharge arc in the liquid; so as to allow current to pass through the first electrode 301, the first intermediate electrode 302, and the second electrode 303 in sequence.

[0045] Optionally, a sealing portion is provided at the connection between the axial end surface of the positioning sheath 4 and the catheter; and a sealing portion is provided at the connection between the axial end surface of the positioning sheath 4 and the electrode assembly. The sealing portion prevents liquid from entering the positioning sheath 4, thereby ensuring that only the discharge portion of the first electrode 301, the first intermediate electrode 302, and the second electrode 303 can come into contact with the liquid in the balloon 2. Optionally, the sealing portion is a sealant applied to the axial end surface of the positioning sheath 4.

[0046] In the above embodiment, the discharge portions of the first electrode 301 , the first intermediate electrode 302 and the second electrode 303 are all located outside the axial coverage area of ​​the positioning sleeve 4 , so the positioning sleeve 4 does not need to have a hole, so that the positioning sleeve 4 has good integrity and stability, is not easily deformed or damaged, and has a long product life.

[0047] The cross-section at the location of the electrode assembly 3 includes a catheter 1, the electrode assembly 3 sleeved on the outer periphery of the catheter 1, and a positioning sheath 4 sleeved on the outer periphery of the electrode assembly 3. The diameter of the cross-section at this location (i.e., the outer wall diameter of the positioning sheath 4) can be less than 1.2 mm, and has good permeability in the blood vessels; the thickness of the positioning sheath 4 formed by thermoplastic molding can be as low as 0.01 mm, so the positioning sheath 4 has a very low impact on the cross-sectional size of the catheter 1 while effectively fixing the electrode assembly 3.

[0048] Optionally, the intermediate electrode unit includes a first intermediate electrode, a second intermediate electrode, ..., and an Nth intermediate electrode, where N ≥ 1; the first intermediate electrode, the second intermediate electrode, ..., and the Nth intermediate electrode respectively include a discharge portion; each of the discharge portions is located outside the axial coverage area of ​​the positioning sheath, and each of the discharge portions can contact the liquid in the balloon;

[0049] The first electrode, the first intermediate electrode, the second intermediate electrode, ..., the Nth intermediate electrode, and the second electrode are sequentially spaced apart along the circumference of the catheter;

[0050] When a voltage is applied between the first electrode and the second electrode, the discharge portion of the first electrode and the discharge portion of the intermediate electrode unit are configured to form a discharge arc in the liquid; the discharge portion of the i-th intermediate electrode and the discharge portion of the i+1-th intermediate electrode are configured to form a discharge arc in the liquid, 1≤i≤N-1; the discharge portion of the N-th intermediate electrode unit and the discharge portion of the second electrode are configured to form a discharge arc in the liquid; so as to allow current to pass through the first electrode, the first intermediate electrode, the second intermediate electrode,..., the N-th intermediate electrode, and the second electrode in sequence.

[0051] In the optional embodiment shown in FIG3 , the discharge portion of the first electrode comprises a portion of the outer peripheral wall at the proximal or distal end of the first electrode; the portion of the outer peripheral wall at the proximal or distal end of the first electrode is located outside the axial coverage area of ​​the positioning sheath and constitutes the discharge portion. The discharge portions of the remaining electrodes may also be the outer peripheral walls at the proximal or distal ends of the electrodes.

[0052] In the optional embodiment shown in FIG5 , the positioning sheath includes a first sheath 401 and a second sheath 402. The first sheath 401 and the second sheath 402 are spaced axially and wrap around the periphery of an electrode assembly. In the axial gap between the first sheath 401 and the second sheath 402, i.e., outside the axial coverage area of ​​the first sheath 401 and the second sheath 402, a portion of the outer circumferential wall of the first electrode 301 is exposed to contact the liquid in the balloon, forming a discharge portion. A portion of the outer circumferential wall of the intermediate electrode unit is exposed to contact the liquid in the balloon, forming a discharge portion. A portion of the outer circumferential wall of the second electrode 303 is exposed to contact the liquid in the balloon, forming a discharge portion. The first sheath 401 and the second sheath 402 seal the proximal and distal end faces of the first electrode 301, or the proximal and distal end faces of the first electrode 301 are sealed with insulating adhesive to prevent them from contacting the liquid in the balloon. In this embodiment, the discharge portion of each electrode is located in the middle of the electrode, and the first sheath 401 and the second sheath 402 are distributed on both sides of the discharge portion in the axial direction, so that the discharge portion is more firmly fixed and less likely to be deformed.

[0053] In another optional embodiment, the proximal end surface of the first electrode is flush with the proximal end surface of the positioning sheath; the proximal end surface of the first electrode constitutes the discharge portion;

[0054] and / or,

[0055] The distal end surface of the first electrode is flush with the distal end surface of the positioning sheath; the distal end surface of the first electrode constitutes the discharge portion. In this application, when the proximal end surface of the first electrode is flush with the proximal end surface of the positioning sheath, the proximal end surface of the first electrode is defined as being outside the axial coverage area of ​​the positioning sheath. The proximal or distal end surfaces of the remaining electrodes may also be flush with the positioning sheath, constituting the discharge portion of that electrode.

[0056] When the number of the electrode assemblies 3 is at least 2, optionally, one positioning sheath 4 is correspondingly covered on the outside of each electrode assembly 3; or, one positioning sheath 4 covers the outside of at least 2 electrode assemblies 3; further, the positioning sheath 4 covers the outside of all the electrode assemblies 3 on the catheter 1.

[0057] In an optional embodiment, a developing ring 5 is mounted on the outside of the catheter 1. Positioned within the balloon 2, the developing ring 5 is used to mark the position of the balloon 2 within the human body using an imaging system. Preferably, the developing ring 5 is positioned outside the electrode assembly 3, rather than overlapping it, to prevent the catheter 1 from having excessively large cross-sectional dimensions.

[0058] Regarding the power supply scheme of the electrode assembly 3, the present application provides an optional embodiment, in which the first electrode 301 of each of the electrode assemblies 3 is electrically connected to the same first power supply terminal of the pulse voltage generator; the second electrode 303 of each of the electrode assemblies 3 is electrically connected to the same second power supply terminal of the pulse voltage generator; the pulse voltage generator is used to provide a pulse voltage to the electrode assembly 3; one of the first power supply terminal and the second power supply terminal is the positive pole of the power supply, and the other is the negative pole of the power supply.

[0059] In another optional embodiment of the present application, the electrode assembly 3 is supplied with a pulse voltage through a pulse voltage generator; the pulse voltage generator includes a plurality of power supply units, each of which corresponds to one of the electrode assemblies 3 and forms a power supply circuit; each of the power supply units includes a first power supply terminal and a second power supply terminal; one of the first power supply terminal and the second power supply terminal is a positive power supply electrode, and the other is a negative power supply electrode; the first power supply terminal of each power supply circuit is electrically connected to the first electrode 301 of a corresponding electrode assembly 3; the second power supply terminal of each power supply circuit is electrically connected to the second electrode 303 of a corresponding electrode assembly 3. In this embodiment, each of the electrode assemblies 3 is powered by an independent power supply circuit, and the working state of each electrode assembly 3 can be individually controlled.

[0060] In another optional embodiment of the present application, at least one of the electrode assemblies 3 includes a first electrode assembly and a second electrode assembly; the second electrode of the first electrode assembly is electrically connected to the first electrode of the second electrode assembly; when a voltage is applied between the first electrode of the first electrode assembly and the second electrode of the second electrode assembly, a discharge arc is generated between the discharge parts to allow current to pass through the first electrode of the first electrode assembly, the intermediate electrode unit of the first electrode assembly, the second electrode of the first electrode assembly, the first electrode of the second electrode assembly, the intermediate electrode unit of the second electrode assembly, and the second electrode of the second electrode assembly in sequence.

[0061] In the above embodiment, the number of the electrode assemblies can be greater. At least one of the electrode assemblies includes a first electrode assembly, a second electrode assembly, ..., a Y-th electrode assembly; wherein Y ≥ 3;

[0062] The second electrode 303 of the kth electrode assembly is electrically connected to the first electrode of the k+1th electrode assembly; wherein 1≤k≤Y-1;

[0063] When a voltage is applied between the first electrode 301 of the first electrode assembly and the second electrode 303 of the Y-th electrode assembly, current is allowed to pass through the first electrode assembly, the second electrode assembly, . . . , the N-th electrode assembly in sequence.

[0064] In the optional embodiment of Figure 6 , the number of electrode assemblies 3 is at least two, and the at least two electrode assemblies 3 include a distal electrode assembly 3a and a proximal electrode assembly 3b; the proximal electrode assembly 3b is located between the pulse voltage generator and the distal electrode assembly 3a; the pulse voltage generator is used to provide a pulse voltage to the electrode assemblies. The distal electrode assembly 3a and the proximal electrode assembly 3b are used to distinguish the two electrode assemblies by their relative positional relationship. When the number of electrode assemblies 3 is greater than two, the distal electrode assembly 3a and the proximal electrode assembly 3b do not specifically refer to a single electrode assembly; any two of the electrode assemblies may be referred to as the distal electrode assembly 3a and the proximal electrode assembly 3b.

[0065] The device further comprises a first wire 6 ; the first wire 6 is electrically connected between the pulse voltage generator and the distal electrode assembly 3 a.

[0066] The first conductive wire 6 is laid along the extension direction of the catheter 1 and must pass through the section where the proximal electrode is located along the axial direction of the catheter 1 . The portion of the first conductive wire 6 located within the section where the proximal electrode is located along the axial direction of the catheter 1 is defined as a first proximal overlapping section 601 .

[0067] Optionally, the first proximal overlapping section is stacked on the outer wall of the proximal electrode assembly. In this embodiment, the first wire will increase the cross-sectional area of ​​the outer contour of the proximal electrode assembly, reducing the passability and compliance of the catheter.

[0068] In the alternative embodiment of FIG6 , the first proximal overlapping section 601 is disposed in the circumferential gap between two adjacent electrodes of the proximal electrode assembly 3 b. In this embodiment, the first wire 6 does not occupy space at the proximal electrode assembly 3 b, thereby increasing the outer cross-sectional area of ​​the proximal electrode assembly 3 b. Compared to the previous embodiment, the catheter 1 has better passability in blood vessels.

[0069] On the one hand, when the first proximal overlapping section 601 is disposed in the circumferential gap between two adjacent electrodes of the proximal electrode assembly 3b, it can be used to maintain insulation isolation between the electrodes of the proximal electrode assembly 3b. Optionally, the first proximal overlapping section 601 is disposed in the circumferential gap between two adjacent electrodes of any electrode pair of the proximal electrode assembly 3b; the first proximal overlapping section 601 is fixedly connected to the corresponding two adjacent electrodes. The present application does not limit the fixing method between the two adjacent electrodes, and fixing structures such as bonding and snapping can be used; thus, the position of the two adjacent electrodes on the catheter 1 is more firmly and stably maintained.

[0070] To enhance treatment effectiveness, multiple discharge locations on an electrode assembly 3 are optionally distributed substantially evenly along the circumference of the catheter. The electrode assembly 3 includes a first electrode 301, a first intermediate electrode 302, and a second electrode 303. In a cross-section of the electrode assembly 3, the two discharge locations are substantially symmetrically distributed relative to the center of the catheter 1. Specifically, the central angles of the two discharge locations relative to the center of the catheter 1 range from 160° to 200°.

[0071] 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.

[0072] 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.

[0073] 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 circumference of the catheter, and an electrode assembly arranged in the balloon, wherein the balloon can be filled with liquid; characterized in that: The electrode assembly comprises a first electrode, an intermediate electrode unit and a second electrode; the first electrode, the intermediate electrode unit and the second electrode are sequentially arranged at intervals along the circumference of the catheter; The device also includes a positioning sheath wrapped around the periphery of the electrode assembly; The first electrode, the intermediate electrode unit and the second electrode respectively include a discharge portion; each of the discharge portions is located outside the axial coverage interval of the positioning sheath, and each of the discharge portions can contact the liquid in the balloon; When a voltage is applied between the first electrode and the second electrode, the discharge portion of the first electrode and the discharge portion of the intermediate electrode unit are configured to form a discharge arc in the liquid, and the discharge portion of the intermediate electrode unit and the discharge portion of the second electrode are configured to form a discharge arc in the liquid; To allow current to pass through the first electrode, the middle electrode unit, and the second electrode in sequence.

2. The device according to claim 1, characterized in that: The intermediate electrode unit comprises a first intermediate electrode, a second intermediate electrode, ..., and an Nth intermediate electrode, where N≥1; the first intermediate electrode, the second intermediate electrode, ..., and the Nth intermediate electrode respectively comprise a discharge portion; each of the discharge portions is located outside the axial coverage interval of the positioning sheath, and each of the discharge portions can contact with the liquid in the balloon; The first electrode, the first intermediate electrode, the second intermediate electrode, ..., the Nth intermediate electrode, and the second electrode are sequentially spaced apart along the circumference of the catheter; When a voltage is applied between the first electrode and the second electrode, the discharge portion of the first electrode and the discharge portion of the intermediate electrode unit are configured to form a discharge arc in the liquid; the discharge portion of the i-th intermediate electrode and the discharge portion of the i+1-th intermediate electrode are configured to form a discharge arc in the liquid, 1≤i≤N-1; the discharge portion of the N-th intermediate electrode unit and the discharge portion of the second electrode are configured to form a discharge arc in the liquid; To allow current to sequentially pass through the first electrode, the first intermediate electrode, the second intermediate electrode, . . . , the Nth intermediate electrode, and the second electrode.

3. The device according to claim 1, characterized in that: The positioning sheath includes a first sheath and a second sheath; the first sheath and the second sheath are spaced apart in the axial direction and wrapped around the outer circumference of an electrode assembly; each of the discharge parts is located at the gap between the first sheath and the second sheath.

4. The device according to claim 1, characterized in that: The discharge portion of the first electrode includes a portion of an outer peripheral wall of the first electrode; the portion of the outer peripheral wall of the first electrode is located outside the axial coverage interval of the positioning sleeve.

5. The device according to claim 1, characterized in that: The proximal end surface of the first electrode is flush with the proximal end surface of the positioning sheath; the proximal end surface of the first electrode constitutes the discharge portion; and / or, The distal end surface of the first electrode is flush with the distal end surface of the positioning sheath; the distal end surface of the first electrode constitutes the discharge portion.

6. The device according to claim 1, characterized in that: The number of the electrode assemblies is at least two, including a first electrode assembly and a second electrode assembly; the second electrode of the first electrode assembly is electrically connected to the first electrode of the second electrode assembly; when a voltage is applied between the first electrode of the first electrode assembly and the second electrode of the second electrode assembly, each of the electrode pairs is configured to form a discharge arc in the liquid, respectively, to allow current to pass through the first electrode of the first electrode assembly, the intermediate electrode unit of the first electrode assembly, the second electrode of the first electrode assembly, the first electrode of the second electrode assembly, the intermediate electrode unit of the second electrode assembly, and the second electrode of the second electrode assembly in sequence.

7. The device according to claim 1, characterized in that: The number of the electrode assemblies is at least two, including a distal electrode assembly and a proximal electrode assembly; the proximal electrode assembly is located between a pulse voltage generator and the distal electrode assembly; the pulse voltage generator is used to provide a pulse voltage for the electrode assembly; The device further comprises a first wire; the first wire is electrically connected between the pulse voltage generator and the distal electrode assembly; The first conductive wire comprises a first proximal overlapping segment; the first proximal overlapping segment is located in the interval where the proximal electrode assembly is located along the axial direction of the catheter; the first proximal overlapping segment is arranged in the circumferential gap between any two adjacent electrodes in the proximal electrode assembly.

8. The device according to claim 1, characterized in that: The intermediate electrode unit comprises a first intermediate electrode; when a voltage is applied between the first electrode and the second electrode, the discharge portion of the first electrode and the discharge portion of the first intermediate electrode are configured to form a discharge arc in the liquid; the discharge portion of the first intermediate electrode and the discharge portion of the second electrode are configured to form a discharge arc in the liquid; To allow current to pass through the first electrode, the first intermediate electrode, and the second electrode in sequence.

9. The device according to claim 8, characterized in that: The cross sections of the first electrode, the first intermediate electrode and the second electrode are all arc-shaped.

10. The device according to claim 1, characterized in that: The positioning sheath comprises Metal core; A sheath insulating layer; the sheath insulating layer is wrapped around the outer surface of the metal inner core and is used to maintain insulation between the metal inner core and the electrode assembly.

11. The device according to claim 1, characterized in that: A sealing portion is provided at the connection between the axial end surface of the positioning sleeve and the catheter; a sealing portion is provided at the connection between the axial end surface of the positioning sleeve and the electrode assembly.

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