Shock wave balloon catheter device

Abstract

The embodiment of the invention provides a shock wave balloon catheter device. The shock wave balloon catheter device comprises a balloon, an electrode assembly arranged in the balloon and a positioning sheath wrapping the periphery of the electrode assembly. The electrode assembly comprises a first electrode, a middle electrode unit and a second electrode which are sequentially arranged at intervals in the circumferential direction of the catheter; the first electrode, the intermediate electrode unit and the second electrode respectively comprise a discharge part; each discharge part is located outside the axial coverage interval of the positioning sheath and can be in contact with liquid in the balloon; when a voltage is applied between the first electrode and the second electrode, the discharge part of the first electrode and the discharge part of the intermediate electrode unit can form a discharge arc in the liquid, and the discharge part of the intermediate electrode unit and the discharge part of the second electrode can form a discharge arc in the liquid; current is allowed to sequentially pass through the first electrode, the middle electrode unit and the second electrode. The positioning sheath provided by the embodiment of the invention does not need to be holed, so that the positioning sheath has good integrity and stability, is not easy to deform and damage, and is long in service life.

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 the disease progresses, plaques in peripheral blood vessels and coronary arteries gradually calcify. This bone-like structure analogue causes vascular stenosis, reduces vascular blood flow, and may eventually lead to complete vascular occlusion. A shock wave balloon catheter device is provided for vascular calcification lesions; during treatment, the balloon on the catheter is pushed into the vascular calcification area; the balloon is then inflated and pressurized with liquid; a high-voltage pulse is applied to the electrode pair in the balloon, causing the electrode pair to discharge and generate shock waves in the liquid; the shock wave hits the balloon wall, rupturing the calcified plaque; after the calcified plaque ruptures, the balloon can be further inflated to open the vessel.

[0003] In an optional embodiment, the first electrode and the second electrode are radially stacked and installed on the catheter, and in order to prevent the first electrode and the second electrode from being short-circuited, an insulating medium layer needs to be stacked between the first electrode and the second electrode; and a hole needs to be opened on the second electrode and the insulating medium layer so that the first electrode can be exposed and contact the liquid in the balloon. The openings on the second electrode and the insulating medium layer reduce the strength of the second electrode and the insulating medium layer, and the openings are easily deformed and damaged, which reduces the service life of the product. Summary of the invention

[0004] The embodiments of the present application provide a shock wave balloon catheter device with a long product life.

[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, and an electrode assembly arranged in the balloon, wherein the balloon can be filled with 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 and arranged along the circumference of the catheter;

[0006] The device also includes a positioning sheath wrapped around the periphery of the electrode assembly;

[0007] 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;

[0008] 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.

[0009] 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 area 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

[0010] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. 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 paying any creative labor.

[0011] Figure 1 A schematic diagram of the structure of a shock wave balloon catheter device provided in one embodiment of the present application;

[0012] Figure 2 A schematic diagram of the structure of a cross section of an electrode assembly provided in one embodiment of the present application;

[0013] Figure 3 An axonometric view of an electrode assembly provided for one embodiment of the present application;

[0014] Figure 4 An isometric perspective view of an electrode assembly provided for one embodiment of the present application;

[0015] Figure 5 An axonometric view of an electrode assembly provided for another embodiment of the present application;

[0016] Figure 6 An axonometric view of an electrode assembly provided for one embodiment of the present application. DETAILED DESCRIPTION

[0017] The technical solution of the present invention will be described in detail below in conjunction with the accompanying drawings and specific implementation methods. It should be understood that these implementation methods are only used to illustrate the present invention and are not used to limit the scope. After reading the present invention, various equivalent forms of modifications to the present invention by those skilled in the art all fall within the scope defined in this application.

[0018] 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 considered to be "connected to" another element, it may be directly connected to the other element or there may be an intermediate element at the same time.

[0019] The following will be combined Figures 1 to 6 The shock wave balloon catheter device of the embodiment of this specification is explained and described. It should be noted that in the embodiment of the present invention, the same reference numerals represent the same components. For the sake of brevity, the detailed description of the same components is omitted in different embodiments, and the descriptions of the same components can be referenced and quoted to each other.

[0020] As heart disease patients age and the disease progresses, plaques in peripheral blood vessels and coronary arteries gradually calcify. This bone-like structure can cause narrowing of the vessels, reduce blood flow in the vessels, and may eventually lead to complete occlusion of the vessels.

[0021] The indications of the shock wave balloon catheter device include interventional treatment of vascular calcification lesions. The shock wave balloon catheter device includes a catheter, a balloon sealed around the outer circumference of the catheter, and at least one electrode pair arranged in the balloon; the balloon can be filled with liquid; each of the electrode pairs includes a first electrode and a second electrode; when a voltage is applied between the first electrode and the second electrode, a plasma arc is formed in the liquid in the balloon between the first electrode and the second electrode, thereby generating bubbles in the liquid, which expand and collapse, and then forming a mechanical shock wave in the balloon, which is mechanically transmitted through the liquid and the balloon to apply mechanical force or pressure to split any calcified plaque on or in the wall of the vascular system.

[0022] When the device is used clinically, the balloon in a decompressed state should first be delivered to the site of the calcified lesion, and the balloon should be pressurized to ensure that it fits tightly against the blood vessel wall; then a voltage is applied between the first electrode and the second electrode, and the liquid in the balloon between the first electrode and the second electrode forms a discharge shock wave. The shock wave impacts and destroys the calcified lesion, causing the calcification of the intima and the media to break. The modification effect of the calcified lesion can be judged by evaluating the symmetrical expansion of the balloon.

[0023] The shock wave balloon catheter device efficiently and safely destroys superficial and deep calcifications, thereby significantly improving vascular compliance. The device is effective not only for superficial and deep calcifications, but also for eccentric and non-eccentric lesions, reducing the risk of complications such as dissection and perforation.

[0024] In the above-mentioned shock wave balloon catheter device, the balloon is carried by the catheter to move in the blood vessels. In some cases, the blood vessels have already suffered from severe stenosis or even complete occlusion. Therefore, it is necessary to reduce the cross-sectional area of ​​the catheter as much as possible and improve the flexibility of the catheter so that it has good permeability in the blood vessels.

[0025] 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, it is necessary to stack an insulating medium layer between the first electrode and the second electrode; and it is also necessary to open a hole in the second electrode and the insulating medium layer so that the first electrode can be exposed and contact the liquid in the balloon.

[0026] In this structure, two layers of electrodes and one insulating medium layer are superimposed on the outer wall of the catheter, so that the cross-sectional area of ​​the electrode pair is large, the flexibility is poor, and it is difficult to pass through the blood vessels with severe stenosis or completely occluded lesions, and the permeability is poor. In addition, the openings on the second electrode and the insulating medium layer reduce the strength of the second electrode and the insulating medium layer, and the openings are prone to deformation and damage.

[0027] An optional embodiment of the shock wave balloon catheter device provided by the present application is as follows: Figure 1 As shown, the shock wave balloon catheter device comprises a catheter 1, a balloon 2 sealed around the outer circumference of the catheter 1, and at least one electrode assembly 3 disposed in the balloon 2; the balloon 2 can be filled with liquid, wherein the liquid includes but is not limited to water, saline, contrast agent and a mixture thereof.

[0028] 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.

[0029] 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 arranged at intervals along the circumference of the catheter 1 .

[0030] Specifically, the intermediate electrode unit includes a first intermediate electrode, a second intermediate electrode, ..., an Nth intermediate electrode, N≥1; the first electrode, the first intermediate electrode, the second intermediate electrode, ..., the Nth intermediate electrode, and the second electrode are sequentially spaced along the circumference of the catheter. In this embodiment, the first, second, ..., and Nth intermediate electrodes are defined to define a continuous natural number sequence, which is used to describe the naming method of multiple intermediate electrodes when multiple intermediate electrodes are provided; therefore, the embodiment in which the intermediate electrode unit has only one first intermediate electrode is not excluded.

[0031] In this embodiment, the first intermediate electrode, the second intermediate electrode, ..., and the Nth intermediate electrode are neither grounded through a wire nor connected to a power source through a wire.

[0032] like Figure 2 In the illustrated embodiment, the intermediate electrode unit includes a first intermediate electrode 302; each of the electrode assemblies 3 includes a first electrode 301, a first intermediate electrode 302, and a second electrode 303, and the first electrode 301, the first intermediate electrode 302, and the second electrode 303 are arranged at intervals along the circumference of the conduit 1. Optionally, the cross-sectional shapes of the first electrode 301, the first intermediate electrode 302, and the second electrode 303 are all arc-shaped, and the inner wall of the first electrode 301 and the inner wall of the first intermediate electrode 302 are respectively attached to the outer wall of the conduit 1, so that the connection is more stable and the cross-sectional size is reduced. The first electrode 301, the first intermediate electrode 302, and the second electrode 303 are arranged at intervals in sequence along the circumference of the conduit 1.

[0033] It can be understood that the number of intermediate electrodes in the intermediate electrode unit is not limited to the present embodiment; for example, N=2, then each of the electrode assemblies 3 includes a first electrode 301, a first intermediate electrode 302, a second intermediate electrode, and a second electrode 303, and the first electrode 301, the first intermediate electrode 302, the second intermediate electrode, and the second electrode 303 are arranged at intervals 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; 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 pair is configured to form a discharge arc in the liquid, respectively, so as to allow current to pass through the first electrode 301, the first intermediate electrode 302, the second intermediate electrode, and the second electrode 303 in sequence.

[0034] The arc angles of the arc-shaped first electrode 301, the first intermediate electrode 302, and the second electrode 303 may be the same or different. For example, the arc angles of the first electrode 301, the first intermediate electrode 302, and the 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 the second electrode 303 are 100°.

[0035] 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 may be at least partially located in the same interval in the axial direction.

[0036] 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 center angles corresponding to the two gaps 305 are 5°, and the gaps 305 are small enough to form a discharge shock wave; then the center angle between the first electrode 301 and the second electrode 303 is 50°, and since the distance between the first electrode 301 and the second electrode 303 is relatively far, no discharge arc is formed between the first electrode 301 and the second electrode 303.

[0037] When the first electrode 301 is adjacent to the second electrode 303, optionally, an insulating shielding medium is 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 there is no liquid between the first electrode 301 and the second electrode 303, and when a voltage is applied between the first electrode and the second electrode, no discharge arc is formed between the first electrode 301 and the second electrode 303.

[0038] During the process of the electrode assembly 3 following the movement of the catheter 1 in the human body's blood vessels and the discharge process, the electrode assembly 3 will bend along with the catheter 1 and be subject to the resistance exerted by the blood vessels and mechanical vibration, 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.

[0039] Optionally, the positioning sleeve 4 is made of insulating material through thermoplastic molding.

[0040] Alternatively, the positioning sheath 4 includes a metal inner core and a sheath insulation layer; the sheath insulation layer is wrapped around the outer surface of the metal inner core to maintain insulation between the metal inner core and the electrode assembly; the sheath insulation can specifically be an insulating coating coated on the outer wall of the metal inner core. The positioning sheath 4 made of this material has higher strength and is not easily deformed or damaged.

[0041] 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.

[0042] exist Figure 3and Figure 4 In the optional embodiment shown, the first electrode 301, the first intermediate electrode 302 and the second electrode 303 respectively include a discharge portion; each of the discharge portions is located outside the axial coverage interval of the positioning sheath 4, and each of the discharge portions can contact the liquid in the balloon 2;

[0043] 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.

[0044] Optionally, a sealing portion is provided at the connection between the axial end face of the positioning sheath 4 and the catheter; and a sealing portion is provided at the connection between the axial end face 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 contact the liquid in the balloon 2. Optionally, the sealing portion is a sealant coated on the axial end face of the positioning sheath 4.

[0045] In the above embodiment, the discharge parts 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 be opened, so that the positioning sleeve 4 has good integrity and stability, is not easy to deform and damage, and has a long product service life.

[0046] 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; wherein 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 little effect on the cross-sectional size of the catheter 1 while effectively fixing the electrode assembly 3.

[0047] 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 interval of the positioning sheath, and each of the discharge portions can contact the liquid in the balloon;

[0048] 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;

[0049] 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.

[0050] exist Figure 3 In the optional embodiment shown, the discharge portion of the first electrode includes a portion of the outer peripheral wall of the proximal end or distal end of the first electrode; the portion of the outer peripheral wall of the proximal end or distal end of the first electrode is located outside the axial coverage area of ​​the positioning sheath, constituting the discharge portion. The discharge portion of the remaining electrodes may also be the outer peripheral wall of the proximal end or distal end of the electrode.

[0051] exist Figure 5 In the optional embodiment shown, the positioning sheath includes a first sheath 401 and a second sheath 402; the first sheath 401 and the second sheath 402 are spaced apart in the axial direction and wrapped around the periphery of an electrode assembly; at the axial gap between the first sheath 401 and the second sheath 402, that is, outside the axial coverage interval of the first sheath 401 and the second sheath 402, part of the outer peripheral wall of the first electrode 301 is exposed to contact the liquid in the balloon, forming a discharge part; part of the outer peripheral wall of the intermediate electrode unit is exposed to contact the liquid in the balloon, forming a discharge part, and part of the outer peripheral wall of the second electrode 303 is exposed to contact the liquid in the balloon, forming a discharge part. The first sheath 401 and the second sheath 402 seal and wrap the proximal end face and the distal end face of the first electrode 301, or seal the proximal end face and the distal end face of the first electrode 301 with insulating glue so that they cannot contact 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.

[0052] 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;

[0053] and / or,

[0054] 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 the present 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 interval of the positioning sheath. The proximal or distal end surfaces of the remaining electrodes may also be flush with the positioning sheath to constitute the discharge portion of the electrode.

[0055] 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 two electrode assemblies 3; further, the positioning sheath 4 covers the outside of all the electrode assemblies 3 on the catheter 1.

[0056] In an optional embodiment, a developing ring 5 is sleeved on the outside of the catheter 1. The developing ring 5 is located in the balloon 2 and is used to mark the position of the balloon 2 in the human body through an imaging system. Preferably, the developing ring 5 is located in an area outside the electrode assembly 3, and is not placed overlapping with the electrode assembly 3, so as to prevent the local cross-sectional size of the catheter 1 from being too large.

[0057] 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.

[0058] 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 controlled individually.

[0059] 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.

[0060] In the previous embodiment, the number of the electrode assemblies may be greater. At least one of the electrode assemblies includes a first electrode assembly, a second electrode assembly, ..., a Yth electrode assembly; wherein Y≥3;

[0061] 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;

[0062] 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.

[0063] exist Figure 6 In an optional embodiment, the number of the electrode assemblies 3 is at least two, and at least two of the 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 assembly. The distal electrode assembly 3a and the proximal electrode assembly 3b are used to distinguish the two electrode assemblies by the relative positional relationship between the two electrode assemblies. When the number of the electrode assemblies 3 is greater than two, the distal electrode assembly 3a and the proximal electrode assembly 3b do not specifically refer to a certain electrode assembly, and any two of the electrode assemblies can be referred to as the distal electrode assembly 3a and the proximal electrode assembly 3b.

[0064] 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 3a.

[0065] 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 .

[0066] 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 at the proximal electrode assembly, reducing the passability and compliance of the catheter.

[0067] exist Figure 6 In an optional embodiment, the first proximal overlapping section 601 is arranged at the circumferential gap between two adjacent electrodes of the proximal electrode assembly 3b. In this embodiment, the first wire 6 is prevented from occupying space at the proximal electrode assembly 3b, which results in an increase in the outer contour cross-sectional area at the proximal electrode assembly 3b. Compared with the previous embodiment, the catheter 1 has better passability in the blood vessel.

[0068] On the one hand, when the first proximal overlapping section 601 is arranged at 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 arranged at 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, and the present application does not limit the fixing method between the two, and a fixing structure such as bonding, snapping, etc. can be used; so that the position of the two adjacent electrodes on the catheter 1 is more firm and stable.

[0069] In order to improve the treatment effect, optionally, multiple discharge positions on an electrode assembly 3 are substantially evenly distributed 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; on the cross section of the electrode assembly 3, two discharge positions are substantially symmetrically distributed relative to the center of the catheter 1; specifically, the value range of the central angle of the two discharge positions relative to the center of the catheter 1 is 160° to 200°.

[0070] It should be noted that, in the description of this specification, the terms "first", "second", etc. are only used for descriptive purposes and to distinguish similar objects. There is no order of precedence between the two, and they cannot be understood as indicating or implying relative importance. In addition, in the description of this specification, unless otherwise specified, the meaning of "plurality" is two or more.

[0071] The above embodiments are only for illustrating the technical concept and features of the present application, and their purpose is to enable people familiar with the technology to understand the content of the present application and implement it accordingly, and they cannot be used to limit the protection scope of the present application. Any equivalent changes or modifications made according to the spirit of the present application should be included in the protection scope of the present application.

[0072] It should be understood that the above description is for illustration and not for limitation. By reading the above description, many embodiments and many applications beyond the provided examples will be apparent to those skilled in the art. For comprehensive purposes, all articles and references, including the disclosures of patent applications and announcements, 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 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 interval of the positioning sheath, and each of the discharge portions can contact 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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