Shock wave balloon catheter device

Abstract

An embodiment of the present application provides a shock wave balloon catheter device, comprising a catheter, a balloon, an electrode pair and a wire; the first electrode and the second electrode of the electrode pair are arranged at intervals along the circumference of the catheter, and a first gap and a second gap are provided between the first electrode and the second electrode, and a discharge shock wave is formed through at least one of the first gap and the second gap, so that only a single layer of electrodes is arranged on the periphery of the catheter; the electrode pair comprises a distal electrode pair and a proximal electrode pair; the wire comprises a first wire connected between the pulse voltage generator and the distal electrode pair; the first wire comprises a first proximal overlapping section located in the interval where the proximal electrode is located along the axial direction of the catheter; the first proximal overlapping section of the first wire is arranged in the first gap or the second gap of the proximal electrode pair, thereby avoiding the first wire occupying space at the proximal electrode pair, resulting in an increase in the outer contour cross-sectional area at the proximal electrode pair; in summary, the catheter in the embodiment of the present application has good passability in the blood vessel.

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 narrow the vessels, reduce blood flow, and ultimately lead to complete occlusion.

[0003] A shock wave balloon catheter device is provided for vascular calcification lesions. During treatment, the balloon on the catheter is pushed into the area of ​​vascular calcification. The balloon is then inflated and pressurized with fluid. High-voltage pulses are applied to the electrode pairs in the balloon, causing the electrode pairs to discharge and generate shock waves in the fluid. The shock waves strike the balloon wall, rupturing the calcified plaque. After the calcified plaque ruptures, the balloon can be further inflated to open the blood vessel.

[0004] In the shock wave balloon catheter device, the balloon is carried by the catheter and moves in the blood vessels, so the catheter needs to have good passability in the blood vessels. Summary of the Invention

[0005] The embodiments of the present application provide a shock wave balloon catheter device having good permeability in blood vessels.

[0006] In one embodiment, a shock wave balloon catheter device is provided, comprising

[0007] catheter;

[0008] sealing a balloon surrounding the circumference of the catheter;

[0009] At least two electrode pairs are disposed within the balloon; each of the electrode pairs comprises a first electrode and a second electrode;

[0010] The wire has an outer insulating layer; the electrode pair is electrically connected to a pulse voltage generator through the wire; the pulse voltage generator is used to provide a pulse voltage to the electrode pair; characterized in that:

[0011] The first electrode and the second electrode are spaced apart along the circumference of the catheter; the first electrode includes a first end face located at one circumferential end of the catheter and a second end face located at the other circumferential end of the catheter; the second electrode includes a third end face located at one circumferential end of the catheter and a fourth end face located at the other circumferential end of the catheter; the first end face and the fourth end face are adjacent to each other and define a first gap; the second end face and the third end face are adjacent to each other and define a second gap; when the pulse voltage generator applies a pulse voltage between the first electrode and the second electrode, the first electrode and the second electrode are configured to form a discharge shock wave in at least one of the first gap and the second gap;

[0012] The at least two electrode pairs include a distal electrode pair and a proximal electrode pair; the proximal electrode pair is located between the pulse voltage generator and the distal electrode pair;

[0013] The guide wire includes a first guide wire connected between the pulse voltage generator and the distal electrode pair; the first guide wire includes a first proximal overlapping segment; the first proximal overlapping segment is located in the interval where the proximal electrode is located along the axial direction of the catheter; the first proximal overlapping segment is arranged in the first gap or the second gap of the proximal electrode pair.

[0014] In the embodiments provided by the present application, the first electrode and the second electrode of the electrode pair are arranged at intervals along the circumference of the catheter, and a first gap and a second gap are provided between the first electrode and the second electrode. A discharge shock wave is formed through at least one of the first gap and the second gap, so that only a single layer of electrodes is arranged on the periphery of the catheter; and by arranging the first proximal overlapping section of the first wire in the first gap or the second gap of the proximal electrode pair, it is avoided that the first wire occupies space at the proximal electrode pair and causes the outer contour cross-sectional area at the proximal electrode pair to increase; in summary, in the embodiments provided by the present application, the catheter has good passability in the blood vessels. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] 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.

[0016] Figure 1 A schematic structural diagram of a shock wave balloon catheter device provided in one embodiment of the present application;

[0017] Figure 2 A schematic diagram of the structure of a cross section of an electrode pair provided in one embodiment of the present application;

[0018] Figure 3 A schematic structural diagram of a shock wave balloon catheter device provided in another embodiment of the present application;

[0019] Figure 4 A cross-sectional view of a catheter, an electrode pair, and a positioning sheath provided in accordance with one embodiment of the present application;

[0020] Figure 5 A schematic structural diagram of a catheter, an electrode pair, and a positioning sheath provided in one embodiment of the present application;

[0021] Figure 6 A schematic structural diagram of a catheter, an electrode pair, and a positioning sheath provided in another embodiment of the present application;

[0022] Figure 7 A schematic structural diagram of a cross section of a catheter provided in accordance with an embodiment of the present application;

[0023] Figure 8 A schematic structural diagram of a cross section of an electrode pair provided in another embodiment of the present application;

[0024] Figure 9 An axonometric diagram of an electrode pair provided in accordance with one embodiment of the present application;

[0025] Figure 10 A schematic structural diagram of a cross section of an electrode pair provided in another embodiment of the present application;

[0026] Figure 11 A radial view of an electrode pair provided for one embodiment of the present application;

[0027] Figure 12 A schematic structural diagram of a cross section of an electrode pair provided in another embodiment of the present application;

[0028] Figure 13 A schematic structural diagram of a cross section of an electrode pair provided in another embodiment of the present application;

[0029] Figure 14 A schematic structural diagram of a cross section of an electrode pair provided in another embodiment of the present application;

[0030] Figure 15 A schematic diagram of the connection between a pulse voltage generator and an electrode pair provided in one embodiment of the present application;

[0031] Figure 16 A schematic diagram of the connection structure of the electrode pairs and the wires provided in an embodiment of the present application, in which the distal electrode pair and the proximal electrode pair are respectively electrically connected to the pulse voltage generator via a power supply circuit;

[0032] Figure 17 for Figure 16 Schematic diagram of the AA cross-sectional structure;

[0033] Figure 18 This is a schematic diagram of the connection structure of the electrode pairs and the wires provided in another embodiment of the present application, in which the distal electrode pair and the proximal electrode pair are respectively electrically connected to the pulse voltage generator via a power supply circuit;

[0034] Figure 19 A schematic diagram of the connection structure of the electrode pairs and the wires provided in an embodiment of the present application in which the distal electrode pair and the proximal electrode pair are connected in series to the pulse voltage generator;

[0035] Figure 20 This is a schematic diagram of the connection structure of the electrode pair and the wire provided in another embodiment of the present application in which the distal electrode pair and the proximal electrode pair are connected in series to the pulse voltage generator;

[0036] Figure 21 A schematic diagram of the cross-sectional structure of an electrode pair, an insulating medium, and a wire provided in one embodiment of the present application;

[0037] Figure 22 A schematic diagram of the cross-sectional structure of an electrode pair, an insulating medium, and a wire provided in another embodiment of the present application.

[0038] Description of reference numerals:

[0039] 1. Catheter; 101. First tube inner cavity; 102. Second tube inner cavity; 103. Second discharge hole;

[0040] 2. Balloon;

[0041] 3. Electrode pair; 3a. Distal electrode pair; 3b. Proximal electrode pair; 301. First electrode; 302. Second electrode; 3011. First end surface; 3011a. Raised portion; 3012. Second end surface; 3021. Third end surface; 3022. Fourth end surface; 3022a. Groove; 303. First gap; 304. Second gap;

[0042] 4. Positioning sheath; 401. First discharge hole;

[0043] 5. Insulating medium; 501. First insulating strip; 502. Second insulating strip;

[0044] 6. Pulse voltage generator;

[0045] 7. Development ring;

[0046] 801, first conductor; 801a, first distal overlapping segment; 801b, first proximal overlapping segment; 802, second conductor; 803, third conductor; 804, fourth conductor; 804a, fourth distal overlapping segment; 804b, fourth proximal overlapping segment. DETAILED DESCRIPTION

[0047] 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.

[0048] 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.

[0049] The following will be combined Figures 1 to 22 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.

[0050] 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.

[0051] The shock wave balloon catheter device is indicated for interventional treatment of vascular calcification. 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 fluid. 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 in the fluid within the balloon between the first and second electrodes, thereby generating bubbles within the fluid. The bubbles expand and collapse, subsequently generating a mechanical shock wave within the balloon. The mechanical shock wave is mechanically transmitted through the fluid and the balloon to apply mechanical force or pressure to break apart any calcified plaque on or in the wall of the vascular system.

[0052] 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 between the first and second electrodes. 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.

[0053] 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.

[0054] 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.

[0055] 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, a layer of insulating medium is stacked between the first and second electrodes. This configuration, with two layers of electrodes and a layer of insulating medium stacked on the catheter's outer wall, results in a larger cross-sectional area at the location of the electrode pair, resulting in poor flexibility and difficulty in passing through vessels with severe stenosis or complete occlusion.

[0056] 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 includes a catheter 1, a balloon 2 sealed around the outer circumference of the catheter 1, and at least one electrode pair 3 disposed in the balloon 2; the balloon 2 can be filled with fluid, wherein the fluid includes but is not limited to water, saline, contrast agent, and mixtures thereof.

[0057] Optionally, in this embodiment, the number of the electrode pairs 3 is at least 2, and at least 2 electrode pairs 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.

[0058] like Figure 2As shown, each electrode pair 3 includes a first electrode 301 and a second electrode 302, and the first electrode 301 and the second electrode 302 are spaced apart along the circumference of the catheter 1. Optionally, the cross-sections of the first electrode 301 and the second electrode 302 are both arc-shaped, and the inner walls of the first electrode 301 and the inner walls of the second electrode 302 are respectively attached to the outer wall of the catheter 1, which makes the connection more stable and reduces the cross-sectional size.

[0059] The first electrode 301 includes a first end face 3011 located at one circumferential end of the catheter 1, and a second end face 3012 located at the other circumferential end of the catheter 1; the second electrode 302 includes a third end face 3021 located at one circumferential end of the catheter 1, and a fourth end face 3022 located at the other circumferential end of the catheter 1; the first end face 3011 is adjacent to the fourth end face 3022 and defines a first gap 303; the second end face 3012 is adjacent to the third end face 3021 and defines a second gap 304.

[0060] The arc angles of the arc-shaped first electrode 301 and the second electrode 302 may be the same or different. For example, the arc angles of the first electrode 301 and the second electrode 302 are both 175°; or the arc angle of the first electrode 301 is 120°, and the arc angle of the second electrode 302 is 100°.

[0061] The lengths of the first electrode 301 and the second electrode 302 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.

[0062] When a pulse voltage is applied between the first electrode 301 and the second electrode 302, a potential difference is formed between the first electrode 301 and the second electrode 302, and a discharge shock wave is generated in at least one of the first gap 303 and the second gap 304. When the pulse voltage is applied between the first electrode 301 and the second electrode 302, the balloon 2 needs to be filled with fluid.

[0063] Optionally, the first gap 303 between the first electrode 301 and the second electrode 302 is relatively small, allowing for the formation of a discharge shock wave; while the second gap 304 is relatively large, preventing the formation of a discharge shock wave. For example, if the arc angle of the first electrode 301 is 120° and the arc angle of the second electrode 302 is 100°, and the central angle between the first end face 3011 and the fourth end face 3022 is 5°, the first gap 303 is sufficiently small to allow for the formation of a discharge shock wave; however, if the central angle between the second end face 3012 and the third end face 3021 is 135°, the second gap 304 does not form a discharge shock wave due to the greater distance between the second end face 3012 and the third end face 3021.

[0064] In this embodiment, the first gap 303 and the second gap 304 are both sufficiently small that, when a voltage is applied between the first electrode 301 and the second electrode 302, a discharge shock wave can be generated in both the first gap 303 and the second gap 304. For example, if the arc angles of the first electrode 301 and the second electrode 302 are both 175° and they are arranged symmetrically, then the central angle between the first end surface 3011 and the fourth end surface 3022 is 5°, and the central angle between the second end surface 3012 and the third end surface 3021 is also 5°. Thus, a discharge shock wave can be generated in both the first gap 303 and the second gap 304.

[0065] Optionally, between two adjacent electrode pairs 3, the gap between one electrode pair 3 capable of generating a discharge shock wave and the gap between the other electrode pair 3 capable of generating a discharge shock wave are spaced apart along the circumference of the catheter 1. This configuration makes the shock wave applied to the lesion more dispersed, which is beneficial for breaking up calcified plaques.

[0066] In the above embodiment, the first electrode 301 and the second electrode 302 are arranged at intervals along the circumference of the catheter 1; therefore, only a single layer of electrodes is arranged on the periphery of the catheter 1, with a small cross-sectional area and good flexibility, so that the catheter 1 has good permeability in the blood vessels.

[0067] In an optional embodiment, the device further includes a wire; the wire has an outer insulating layer; the electrode pair 3 is electrically connected to a pulse voltage generator 6 via the wire; the pulse voltage generator 6 is used to provide a pulse voltage to the electrode pair.

[0068] In an optional embodiment, the number of electrode pairs 3 is at least two, and the at least two electrode pairs 3 include a distal electrode pair 3a and a proximal electrode pair 3b; the proximal electrode pair 3b is located between the pulse voltage generator 6 and the distal electrode pair 3a. The distal electrode pair 3a and the proximal electrode pair 3b are used to distinguish the two electrode pairs 3 by their relative positional relationship. When the number of electrode pairs 3 is greater than two, the distal electrode pair 3a and the proximal electrode pair 3b do not specifically refer to a single electrode pair 3; any two of the electrode pairs 3 may be referred to as the distal electrode pair 3a and the proximal electrode pair 3b.

[0069] The conductor includes a first conductor 801 connected between the pulse voltage generator 6 and the distal electrode pair 3a; the first conductor 801 is laid along the extension direction of the catheter 1, and must pass through the interval where the proximal electrode is located along the axial direction of the catheter 1. The part of the first conductor 801 located in the interval where the proximal electrode is located along the axial direction of the catheter 1 is defined as the first proximal overlapping segment 801b.

[0070] Optionally, the first proximal overlapping section 801b is stacked on the outer wall of the proximal electrode pair 3b. In this embodiment, the first wire 801 will increase the cross-sectional area of ​​the outer contour at the proximal electrode pair 3b, reducing the passability and compliance of the catheter 1.

[0071] In another optional embodiment, the first proximal overlapping section 801b is disposed within the first gap 303 or the second gap 304 of the proximal electrode pair 3b. In this embodiment, the space occupied by the first wire 801 at the proximal electrode pair 3b does not increase the cross-sectional area of ​​the outer contour of the proximal electrode pair 3b. Compared to the previous embodiment, the catheter 1 has better passability through the vessel. In addition, the first proximal overlapping section 801b is disposed within the first gap 303 or the second gap 304 to maintain insulation between the first electrode 301 and the second electrode 302 of the proximal electrode pair 3b.

[0072] Optionally, the first proximal overlapping section 801b is disposed within the first gap 303 of the proximal electrode pair 3b; the first proximal overlapping section 801b is fixedly connected to the first end surface 3011 of the proximal electrode pair 3b. The present application does not limit the method of fixing the first and second electrodes, and a fixing structure such as bonding or snapping may be used; the first proximal overlapping section 801b is fixedly connected to the fourth end surface 3022 of the proximal electrode pair 3b. In this embodiment, the first electrode 301 and the second electrode 302 of the proximal electrode pair 3b are fixedly connected via the first proximal overlapping section 801b at the first gap 303, thereby making the positions of the first electrode 301 and the second electrode 302 on the catheter 1 more secure and stable.

[0073] The distal electrode pair 3a and the proximal electrode pair 3b can be electrically connected to the pulse voltage generator 6 through an independent power supply circuit respectively; or they can share a power supply circuit, and the distal electrode pair 3a and the proximal electrode pair 3b are connected in series to the pulse voltage generator 6.

[0074] like Figure 15 In an embodiment in which the distal electrode pair 3a and the proximal electrode pair 3b are electrically connected to the pulse voltage generator 6 through an independent power supply circuit, the wire connected between the pulse voltage generator 6 and the distal electrode pair 3a also includes a second wire 802; the second wire 802 includes a second proximal overlapping segment, and the second proximal overlapping segment is located in the interval where the proximal electrode is located along the axial direction of the catheter 1; the first wire 801 is electrically connected between the pulse voltage generator 6 and the first electrode 301 of the distal electrode pair 3a; the second wire 802 is electrically connected between the pulse voltage generator 6 and the second electrode 302 of the distal electrode pair 3a, and of the first electrode 301 and the second electrode 302 of the distal electrode pair 3a, one is electrically connected to the anode of the pulse voltage generator 6, and the other is electrically connected to the cathode of the pulse voltage generator 6.

[0075] Correspondingly, one of the first electrode 301 and the second electrode 302 of the proximal electrode pair 3b is electrically connected to the anode of the pulse voltage generator 6 through a wire, and the other is electrically connected to the cathode of the pulse voltage generator 6 through a wire.

[0076] In this embodiment, the first proximal overlapping segment 801b and the second proximal overlapping segment are arranged in the following manner:

[0077] Optional, such as Figure 16 and Figure 17As shown, the first proximal overlapping section 801b is disposed within the first gap 303 of the proximal electrode pair 3b; the second proximal overlapping section is disposed within the second gap 304 of the proximal electrode pair 3b. This embodiment allows the first end surface 3011 and the fourth end surface 3022 of the proximal electrode pair 3b to be insulated and isolated by the first proximal overlapping section 801b, and the second end surface 3012 and the third end surface 3021 of the proximal electrode pair 3b to be insulated and isolated by the second proximal overlapping section, thereby enhancing device reliability.

[0078] Optionally, the first proximal overlapping section 801b is fixedly connected to the first end surface 3011 of the proximal electrode pair 3b, and the first proximal overlapping section 801b is fixedly connected to the fourth end surface 3022 of the proximal electrode pair 3b; the second proximal overlapping section is fixedly connected to the second end surface 3012 of the proximal electrode pair 3b, and the second proximal overlapping section is fixedly connected to the third end surface 3021 of the proximal electrode pair 3b. In this embodiment, the first electrode 301, the second electrode 302, the first proximal overlapping section 801b, and the second proximal overlapping section of the proximal electrode pair 3b are fixedly connected together to form a ring-shaped structure that is sleeved on the catheter 1. This makes the position of the first electrode 301 and the second electrode 302 of the proximal electrode pair 3b on the catheter 1 more secure and stable, and effectively prevents the first electrode 301 and the second electrode 302 of the proximal electrode pair 3b from falling off the catheter 1.

[0079] Optionally, the first proximal overlapping section 801b and the second proximal overlapping section are both disposed within the first gap 303 of the proximal electrode pair 3b; or the first proximal overlapping section 801b and the second proximal overlapping section are both disposed within the second gap 304 of the proximal electrode pair 3b. In this embodiment, when the distance between the first end surface 3011 and the fourth end surface 3022 of the proximal electrode pair 3b is relatively small, and the distance between the second end surface 3012 and the third end surface 3021 of the proximal electrode pair 3b is relatively large, the following can be performed based on the spacing between the first gap 303 and the second gap 304 of the proximal electrode pair 3b:

[0080] In one case, the first gap 303 of the proximal electrode pair 3b is too small to fit the first proximal overlapping section 801b and the second proximal overlapping section. In this case, the first proximal overlapping section 801b and the second proximal overlapping section can only be placed in the second gap 304 of the proximal electrode pair 3b.

[0081] In another case, the size of the first gap 303 of the proximal electrode pair 3b can accommodate the first proximal overlapping segment 801b and the second proximal overlapping segment at the same time. It is also possible to choose to set the first proximal overlapping segment 801b and the second proximal overlapping segment in the first gap 303 of the proximal electrode pair 3b, so that the first end face 3011 of the proximal electrode pair 3b and the fourth end face 3022 are kept insulated and isolated by the first proximal overlapping segment 801b; and the distance between the second end face 3012 of the proximal electrode pair 3b and the third end face 3021 is relatively large, and the change in the insulation state between the second end face 3012 and the third end face 3021 of the proximal electrode pair 3b can be ignored.

[0082] In the above embodiment, optionally, the first wire 801 is electrically connected to the axial end face of the first electrode 301 of the distal electrode pair 3a close to the pulse voltage generator 6; the second wire 802 is electrically connected to the axial end face of the second electrode 302 of the distal electrode pair 3a close to the pulse voltage generator 6; therefore, the first wire 801 and the second wire 802 have no axial overlapping area with the distal electrode pair 3a, and neither the first wire 801 nor the second wire 802 passes through the first gap 303 and the second gap 304 of the distal electrode pair 3a.

[0083] When no insulating medium is provided within the first gap 303 or the second gap 304 of the distal electrode pair 3a, considering the insulation reliability between the first electrode 301 and the second electrode 302 of the distal electrode pair 3a, optionally, the first conductive wire 801 is electrically connected to the axial end surface of the first electrode 301 of the distal electrode pair 3a on the side away from the pulse voltage generator 6, and / or the second conductive wire 802 is electrically connected to the axial end surface of the second electrode 302 of the distal electrode pair 3a on the side away from the pulse voltage generator 6. The first conductive wire 801 includes a first distal overlapping section 801a, which is located within the section where the distal electrode pair 3a is located along the axial direction of the catheter 1; the second conductive wire 802 includes a second distal overlapping section, which is located within the section where the distal electrode pair 3a is located along the axial direction of the catheter 1.

[0084] In this embodiment, the first distal overlapping segment 801a and the second distal overlapping segment are arranged in the following manner:

[0085] Optional, such as Figure 18As shown, the first distal overlapping section 801a is disposed within the first gap 303 of the distal electrode pair 3a; the second distal overlapping section is disposed within the second gap 304 of the distal electrode pair 3a. This embodiment allows the first end face 3011 and the fourth end face 3022 of the distal electrode pair 3a to be insulated and isolated by the first distal overlapping section 801a, and the second end face 3012 and the third end face 3021 of the distal electrode pair 3a to be insulated and isolated by the second distal overlapping section, thereby enhancing device reliability.

[0086] Optionally, the first distal overlapping section 801a and the second distal overlapping section are both disposed within the first gap 303 of the distal electrode pair 3a; or the first distal overlapping section 801a and the second distal overlapping section are both disposed within the second gap 304 of the distal electrode pair 3a. In this embodiment, when the distance between the first end surface 3011 and the fourth end surface 3022 of the distal electrode pair 3a is relatively small, and the distance between the second end surface 3012 and the third end surface 3021 of the distal electrode pair 3a is relatively large, the following can be performed based on the spacing between the first gap 303 and the second gap 304 of the distal electrode pair 3a:

[0087] In one case, the first gap 303 of the distal electrode pair 3a is too small to fit the first distal overlapping segment 801a and the second distal overlapping segment. Therefore, the first distal overlapping segment 801a and the second distal overlapping segment can only be placed in the second gap 304 of the distal electrode pair 3a.

[0088] In another case, the size of the first gap 303 of the distal electrode pair 3a can accommodate the first distal overlapping segment 801a and the second distal overlapping segment at the same time. In this case, the first distal overlapping segment 801a and the second distal overlapping segment can also be selected to be arranged in the first gap 303 of the distal electrode pair 3a, so that the first end face 3011 and the fourth end face 3022 of the distal electrode pair 3a are insulated and isolated by the first distal overlapping segment 801a; and the distance between the second end face 3012 and the third end face 3021 of the distal electrode pair 3a is relatively large, and the change in the insulation state between the second end face 3012 and the third end face 3021 of the distal electrode pair 3a can be ignored.

[0089] In the embodiment where the distal electrode pair 3a and the proximal electrode pair 3b are connected in series to the pulse voltage generator 6, the wire connected between the pulse voltage generator 6 and the proximal electrode pair 3b includes a third wire 803; the second electrode 302 of the proximal electrode pair 3b is electrically connected to the pulse voltage generator 6 through the third wire 803; the first electrode 301 of the proximal electrode pair 3b is electrically connected to the second electrode 302 of the distal electrode pair 3a through the fourth wire 804; the first electrode 301 of the distal electrode pair 3a is electrically connected to the pulse voltage generator 6 through the first wire 801. When one pole of the pulse voltage generator 6 applies a pulse voltage to the second electrode 302 of the proximal electrode pair 3b through the third wire 803, a discharge arc is generated between the second electrode 302 of the proximal electrode pair 3b and the first electrode 301, so that current flows through the proximal electrode pair 3b; the first electrode 301 of the proximal electrode pair 3b is electrically connected to the second electrode 302 of the distal electrode pair 3a through the fourth wire 804; a discharge arc is generated between the second electrode 302 of the distal electrode pair 3a and the first electrode 301, so that current flows through the distal electrode pair 3a; the first electrode 301 of the distal electrode pair 3a is electrically connected to the other pole of the pulse voltage generator 6 through the first wire 801.

[0090] In an alternative embodiment, if Figure 19 As shown, the first proximal overlapping section 801b is arranged in the first gap 303 or the second gap 304 of the proximal electrode pair 3b; the first wire 801 is electrically connected to the axial end face of the first electrode 301 of the distal electrode pair 3a close to the pulse voltage generator 6; the third wire 803 is electrically connected to the axial end face of the second electrode 302 of the proximal electrode pair 3b close to the pulse voltage generator 6; one end of the fourth wire 804 is electrically connected to the axial end face of the first electrode 301 of the proximal electrode pair 3b away from the pulse voltage generator 6, and the other end of the fourth wire 804 is electrically connected to the axial end face of the second electrode 302 of the distal electrode pair 3a close to the pulse voltage generator 6. Therefore, the first wire 801 and the fourth wire 804 have no axial overlapping section with the distal electrode pair 3a, and the first wire 801 and the fourth wire 804 do not pass through the first gap 303 and the second gap 304 of the distal electrode pair 3a, and the third wire 803 and the fourth wire 804 have no axial overlapping section with the proximal electrode pair 3b, and the third wire 803 and the fourth wire 804 do not pass through the first gap 303 and the second gap 304 of the proximal electrode pair 3b.

[0091] When no insulating medium is provided in the first gap 303 and the second gap 304 of the proximal electrode pair 3b, and considering the insulation reliability between the first electrode 301 and the second electrode 302 of the proximal electrode pair 3b, it is required that the first gap 303 and the second gap 304 of the proximal electrode pair 3b are both isolated by wire insulation, the following options are optional:

[0092] The third wire 803 is electrically connected to the axial end surface of the second electrode 302 of the proximal electrode pair 3b away from the pulse voltage generator 6. The third wire 803 includes a third proximal overlapping section, which is located within the section where the proximal electrode is located along the axial direction of the catheter 1; the first proximal overlapping section 801b is arranged within the first gap 303 of the proximal electrode pair 3b; and the third proximal overlapping section is arranged within the second gap 304 of the proximal electrode pair 3b.

[0093] or,

[0094] like Figure 20 As shown, the fourth wire 804 is electrically connected to the axial end surface of the first electrode 301 of the proximal electrode pair 3b close to the pulse voltage generator 6, and the fourth wire 804 includes a fourth proximal overlapping section 804b, and the fourth proximal overlapping section 804b is located in the section where the proximal electrode is located along the axial direction of the catheter 1;

[0095] The first proximal overlapping section 801b is disposed in the first gap 303 of the proximal electrode pair 3b; the fourth proximal overlapping section 804b is disposed in the second gap 304 of the proximal electrode pair 3b.

[0096] When no insulating medium is provided in the first gap 303 or the second gap 304 of the distal electrode pair 3a, considering the insulation reliability between the first electrode 301 and the second electrode 302 of the distal electrode pair 3a, optionally, the first wire 801 is electrically connected to the axial end face of the first electrode 301 of the distal electrode pair 3a away from the pulse voltage generator 6, and / or the fourth wire 804 is electrically connected to the axial end face of the second electrode 302 of the distal electrode pair 3a away from the pulse voltage generator 6.

[0097] Optional, such as Figure 20 As shown, the first conductive wire 801 includes a first distal overlapping segment 801a, and the first distal overlapping segment 801a is located in the interval where the distal electrode pair 3a is located along the axial direction of the catheter 1; the fourth conductive wire 804 includes a fourth distal overlapping segment 804a, and the fourth distal overlapping segment 804a is located in the interval where the distal electrode pair 3a is located along the axial direction of the catheter 1;

[0098] In this embodiment, the first distal overlapping segment 801a and the fourth distal overlapping segment 804a are arranged in the following manner:

[0099] Optionally, the first distal overlapping section 801a is disposed within the first gap 303 of the distal electrode pair 3a, and the fourth distal overlapping section 804a is disposed within the second gap 304 of the distal electrode pair 3a. This embodiment allows the first end surface 3011 and the fourth end surface 3022 of the distal electrode pair 3a to be insulated and isolated by the first distal overlapping section 801a, and the second end surface 3012 and the third end surface 3021 of the distal electrode pair 3a to be insulated and isolated by the fourth distal overlapping section 804a, thereby enhancing device reliability.

[0100] Optionally, the first distal overlapping segment 801a and the fourth distal overlapping segment 804a are both disposed within the first gap 303 of the distal electrode pair 3a; or the first distal overlapping segment 801a and the fourth distal overlapping segment 804a are both disposed within the second gap 304 of the distal electrode pair 3a. In this embodiment, when the distance between the first end surface 3011 and the fourth end surface 3022 of the distal electrode pair 3a is relatively small, and the distance between the second end surface 3012 and the third end surface 3021 of the distal electrode pair 3a is relatively large, the following can be performed based on the spacing between the first gap 303 and the second gap 304 of the distal electrode pair 3a:

[0101] In one case, the first gap 303 of the distal electrode pair 3a is too small to fit the first distal overlapping segment 801a and the fourth distal overlapping segment 804a. Therefore, the first distal overlapping segment 801a and the fourth distal overlapping segment 804a must be placed in the second gap 304 of the distal electrode pair 3a.

[0102] In another case, the size of the first gap 303 of the distal electrode pair 3a can accommodate the first distal overlapping segment 801a and the fourth distal overlapping segment 804a at the same time. It is also possible to choose to set the first distal overlapping segment 801a and the fourth distal overlapping segment 804a in the first gap 303 of the distal electrode pair 3a, so that the first end face 3011 and the fourth end face 3022 of the distal electrode pair 3a are insulated and isolated by the first distal overlapping segment 801a; and the distance between the second end face 3012 and the third end face 3021 of the distal electrode pair 3a is relatively large, and the change in the insulation state between the second end face 3012 and the third end face 3021 of the distal electrode pair 3a can be ignored.

[0103] The embodiment of the present application also provides another shock wave balloon catheter device, comprising

[0104] Catheter 1;

[0105] A balloon 2 is sealed around the outer circumference of the catheter 1;

[0106] A distal electrode pair 3a and a proximal electrode pair 3b are provided in the balloon 2; the proximal electrode pair 3b is located between the pulse voltage generator 6 and the distal electrode pair 3a; the proximal electrode pair 3b includes a first electrode 301 and a second electrode 302;

[0107] The wire has an outer insulating layer; the distal electrode pair 3a and the proximal electrode pair 3b are electrically connected to a pulse voltage generator 6 via wires; the pulse voltage generator 6 is used to provide a pulse voltage for the distal electrode pair 3a and the proximal electrode;

[0108] The first electrode 301 and the second electrode 302 are arranged at intervals along the circumference of the catheter 1; the first electrode 301 includes a first end surface 3011 located at one circumferential end of the catheter 1, and a second end surface 3012 located at the other circumferential end of the catheter 1; the second electrode 302 includes a third end surface 3021 located at one circumferential end of the catheter 1, and a fourth end surface 3022 located at the other circumferential end of the catheter 1; the first end surface 3011 and the fourth end surface 3022 are adjacent to each other and define a first gap 303; the second end surface 3012 and the third end surface 3021 are adjacent to each other and define a second gap 304; when the pulse voltage generator 6 applies a pulse voltage between the first electrode 301 and the second electrode 302, the first electrode 301 and the second electrode 302 are configured to form a discharge shock wave in at least one of the first gap 303 and the second gap 304;

[0109] The wire includes a first wire connected between the pulse voltage generator 6 and the distal electrode pair 3a; the first wire includes a first proximal overlapping segment; the first proximal overlapping segment is located in the interval where the proximal electrode is located along the axial direction of the catheter 1; the first proximal overlapping segment is arranged in the first gap 303 or the second gap 304 of the proximal electrode pair 3b.

[0110] This embodiment does not impose any limitation on the structure of the distal electrode pair 3a.

[0111] In an optional embodiment, a mounting groove extending in a circumferential direction is provided on the outer wall of the tube body of the catheter 1; the electrode pair 3 is arranged in the mounting groove, such as Figure 1By arranging the electrode pair 3 in the installation groove, the cross-sectional area of ​​the location where the electrode pair 3 is located can be further reduced, thereby improving the passability of the catheter 1.

[0112] As the electrode pair 3 follows the catheter 1 in the body's blood vessels and discharges, the electrode pair 3 bends with the catheter 1 and is subject to the resistance exerted by the blood vessels and mechanical vibrations. This may cause the electrode pair 3 to shift 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 member; the positioning member is used to maintain the relative position between the electrode pair 3 and the catheter 1.

[0113] Optionally, the positioning member is an adhesive layer, and the first electrode 301 and the second electrode 302 are respectively adhered to the catheter 1 through the adhesive layer.

[0114] Optionally, the positioning member is a positioning pin, a positioning bolt, a positioning screw, a rivet or other equivalent structures, and the first electrode 301 and the second electrode 302 are respectively fixed on the catheter 1 by the positioning pin, the positioning bolt, the positioning screw, the rivet or other equivalent structures, and the first electrode 301 and the second electrode 302 can also be fixedly connected by the positioning pin, the positioning bolt, the positioning screw, the rivet or other equivalent structures.

[0115] Optionally, the positioning member is a mortise and tenon structure, an interference fit structure, or other equivalent structures. The first electrode 301 and the second electrode 302 are respectively fixed on the catheter 1 through the mortise and tenon structure, interference fit structure, or other equivalent structures. The first electrode 301 and the second electrode 302 can also be fixedly connected through the mortise and tenon structure, interference fit structure, or other equivalent structures.

[0116] In an optional embodiment, the positioning member includes a positioning sheath 4 of an insulating material arranged on the periphery of the electrode pair 3, such as Figure 3 Optionally, the positioning sheath 4 is formed by thermoplastic molding.

[0117] like Figure 4 As shown, the first electrode 301 and the second electrode 302 are wrapped and fixed on the catheter 1 by the thermoplastically formed positioning sheath 4, which can effectively prevent the first electrode 301 or the second electrode 302 from falling off from the catheter 1 due to various factors during the operation, and the first electrode 301 or the second electrode 302 from being displaced relative to the catheter 1, thereby improving the safety and reliability of the device.

[0118] The positioning sheath 4 is provided with a first discharge hole 401; the first discharge hole 401 is located outside the gap between the first gap 303 and the second gap 304 where a discharge shock wave can be generated. In this embodiment, since both the first gap 303 and the second gap 304 can generate a discharge shock wave, the positioning sheath 4 is provided with the first discharge hole 401 outside the first gap 303 and the second gap 304, respectively. The first discharge hole 401 is used to allow the fluid within the balloon 2 to enter the first gap 303 and the second gap 304. After the fluid in the first gap 303 and the second gap 304 generates bubbles during electrode discharge, the shock wave energy generated by the bubbles can pass through the first discharge hole 401 and reach the wall of the balloon 2.

[0119] When the number of the electrode pairs 3 is at least 2, optionally, as Figure 5 As shown, one positioning sheath 4 is correspondingly covered on the outside of each electrode pair 3; or Figure 6 As shown, one positioning sheath 4 covers the outside of at least two electrode pairs 3 ; further, one positioning sheath 4 is made by thermoplastic molding to cover the outside of all electrode pairs 3 on the catheter 1 .

[0120] In the above embodiment, the cross-section at the position where the electrode pair 3 is located includes the catheter 1, the electrode pair 3 sleeved on the outer periphery of the catheter 1, and the positioning sheath 4 sleeved on the outer periphery of the electrode pair 3. The diameter of the cross-section at this position (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 can effectively fix the electrode pair 3 while having extremely little effect on the cross-sectional size of the catheter 1.

[0121] In another alternative embodiment, Figure 7As shown, the body of the catheter 1 is provided with a first inner cavity 101 and a second inner cavity 102 spaced circumferentially. The first electrode 301 is embedded in the first inner cavity 101, and the second electrode 302 is embedded in the second inner cavity 102. The first inner cavity 101 and the second inner cavity 102 constitute the positioning member, which can maintain the relative position between the electrode pair 3 and the catheter 1. Furthermore, embedding the first electrode 301 and the second electrode 302 separately within the body further reduces the cross-sectional dimensions of the catheter 1 at the location of the electrode pair 3. A second discharge hole 103 is provided on the outer wall of the catheter 1. The second discharge hole 103 is located at the gap between the first gap 303 and the second gap 304 where a discharge shock wave can be generated. In this embodiment, since both the first gap 303 and the second gap 304 can generate a discharge shock wave, the second discharge hole 103 is provided on the outer wall of the catheter 1 at the first gap 303 and the second gap 304, respectively. The second discharge hole 103 is used to allow the fluid in the balloon 2 to enter the first gap 303 and the second gap 304, and after the fluid in the first gap 303 and the second gap 304 generates bubbles during electrode discharge, the shock wave energy generated by the bubbles can reach the wall of the balloon 2 through the second discharge hole 103.

[0122] It should be noted that the positioning member may also be a combination of the above embodiments.

[0123] In the above embodiment, the first end surface 3011 and the fourth end surface 3022 are adjacent to each other and define a first gap 303, while the second end surface 3012 and the third end surface 3021 are adjacent to each other and define a second gap 304. The first gap 303 and the second gap 304 separate the first electrode 301 from the second electrode 302. The positioning member is used to maintain the relative position between the electrode pair 3 and the catheter 1, that is, to keep the first electrode 301 and the second electrode 302 separated. Therefore, it is not necessary to provide an insulating medium at the first gap 303 and the second gap 304.

[0124] However, to facilitate discharge, the distance between the first gap 303 and the second gap 304 is relatively small. In extreme cases, the relative positions of the first electrode 301 and the second electrode 302 may change due to a loose fixation of the first electrode 301 or the second electrode 302, or due to bending of the catheter 1, leading to contact and a short circuit between the first electrode 301 and the second electrode 302. This situation needs to be avoided. Therefore, in an optional embodiment, an insulating medium 5 is provided in the first gap 303 and the second gap 304, at least in the gap where the discharge shock wave can be generated, to prevent contact between the first electrode 301 and the second electrode 302, thereby improving the reliability of the device.

[0125] In this embodiment, both the first gap 303 and the second gap 304 can generate a discharge shock wave, and therefore, an insulating medium 5 is provided at both the first gap 303 and the second gap 304 .

[0126] The space between the first gap 303 and the second gap 304 must contain fluid so that bubbles are generated in the fluid between the first gap 303 and the second gap 304 when a discharge occurs between the first electrode 301 and the second electrode 302. Therefore, the space between the first gap 303 and the second gap 304 cannot be completely occupied by the insulating medium 5; that is, the volume of the insulating medium 5 at the first gap 303 is smaller than that of the first gap 303; and the volume of the insulating medium 5 at the second gap 304 is smaller than that of the second gap 304.

[0127] Optionally, the insulating medium 5 at the first gap 303 is in contact with the first end face 3011, and the contact area between the two is smaller than the surface area of ​​the first end face 3011; the insulating medium 5 at the first gap 303 is in contact with the fourth end face 3022, and the contact area between the two is smaller than the surface area of ​​the fourth end face 3022. Similarly, the insulating medium 5 at the second gap 304 is in contact with the second end face 3012, and the contact area between the two is smaller than the surface area of ​​the second end face 3012; the insulating medium 5 at the second gap 304 is in contact with the third end face 3021, and the contact area between the two is smaller than the surface area of ​​the third end face 3021.

[0128] Optionally, the insulating medium 5 at the first gap 303 is fixedly connected to the first end face 3011. This application does not limit the fixing method between the two, and fixing structures such as bonding, screws, and mortise and tenon can be used. The same applies below; the insulating medium 5 at the first gap 303 is fixedly connected to the fourth end face 3022; in this embodiment, the first electrode 301 and the second electrode 302 are fixedly connected through the insulating medium 5 at the first gap 303, so that the positions of the first electrode 301 and the second electrode 302 on the catheter 1 are more firm and stable. Furthermore, the insulating medium 5 at the second gap 304 is fixedly connected to the second end face 3012; the insulating medium 5 at the second gap 304 is connected to the third end face 3021; ​​the first electrode 301, the second electrode 302, the first gap 303 and the insulating medium 5 at the second gap 304 are fixedly connected together to form a ring structure that is sleeved on the catheter 1, so that the positions of the first electrode 301 and the second electrode 302 on the catheter 1 are more firmly and stably maintained, and the first electrode 301 and the second electrode 302 can be effectively prevented from falling off from the catheter 1.

[0129] In an alternative embodiment, if Figure 8 As shown, at the first gap 303, the width of the insulating medium 5 in the radial direction of the catheter 1 is smaller than the width of the first end surface 3011, and the width of the insulating medium 5 in the radial direction of the catheter 1 is smaller than the width of the fourth end surface 3022. Furthermore, the insulating medium 5 is located on the side close to the outer wall of the catheter 1. In this embodiment, the portion of the space in the first gap 303 radially away from the outer wall of the catheter 1 contains a fluid capable of generating bubbles, so that the shock wave energy generated by the bubbles can reach the wall of the balloon 2 without obstruction.

[0130] Similarly, at the second gap 304, the width of the insulating medium 5 in the radial direction of the catheter 1 is smaller than the width of the second end surface 3012, and the width of the insulating medium 5 in the radial direction of the catheter 1 is smaller than the width of the third end surface 3021. Furthermore, the insulating medium 5 is located on the side closer to the outer wall of the catheter 1. In this embodiment, the portion of the space in the second gap 304 radially away from the outer wall of the catheter 1 contains a fluid capable of generating bubbles, allowing the shock wave energy generated by the bubbles to reach the wall of the balloon 2 unimpeded.

[0131] In another alternative embodiment, Figure 9As shown, at the first gap 303, the length of the insulating medium 5 along the axial direction of the catheter 1 is less than the length of the first end surface 3011, and the length of the insulating medium 5 along the axial direction of the catheter 1 is less than the length of the fourth end surface 3022. In this embodiment, the insulating medium 5 can be positioned at the center of the first gap 303 along the axial direction of the catheter 1, or near either side of the axial direction. In this embodiment, the portion of the space in the first gap 303 along the axial direction of the catheter 1 contains a fluid capable of generating bubbles, so that the shock wave energy generated by the bubbles can reach the wall of the balloon 2 without obstruction.

[0132] Similarly, at the second gap 304, the length of the insulating medium 5 along the axial direction of the catheter 1 is less than the length of the second end surface 3012, and the length of the insulating medium 5 along the axial direction of the catheter 1 is less than the length of the third end surface 3021. In this embodiment, the insulating medium 5 can be positioned at the center of the second gap 304 along the axial direction of the catheter 1, or near either side of the axial direction. In this embodiment, the portion of the space in the second gap 304 along the axial direction of the catheter 1 contains a fluid capable of generating bubbles, so that the shock wave energy generated by the bubbles can reach the wall of the balloon 2 without obstruction.

[0133] exist Figure 10 and Figure 11 In the optional embodiment shown, at the first gap 303, the insulating medium 5 includes a first insulating strip 501 and a second insulating strip 502. Figure 10 As shown, the first insulating strip 501 and the second insulating strip 502 are arranged radially apart from each other along the catheter 1, and the space between the first insulating strip 501 and the second insulating strip 502 is a fluid that can generate bubbles, and the shock wave energy generated by the bubbles can reach the wall of the balloon 2; or as Figure 11 As shown, the first insulating strip 501 and the second insulating strip 502 are arranged axially apart from each other along the catheter 1, and the space between the first insulating strip 501 and the second insulating strip 502 is a fluid that can generate bubbles, and the shock wave energy generated by the bubbles can reach the wall of the balloon 2 without obstacles.

[0134] Similarly, at the second gap 304, the insulating medium 5 includes a first insulating strip 501 and a second insulating strip 502. Optionally, Figure 10 As shown, the first insulating strip 501 and the second insulating strip 502 are arranged radially apart from each other along the catheter 1, and the space between the first insulating strip 501 and the second insulating strip 502 is a fluid that can generate bubbles, and the shock wave energy generated by the bubbles can reach the wall of the balloon 2; or as Figure 11As shown, the first insulating strip 501 and the second insulating strip 502 are arranged axially apart from each other along the catheter 1, and the space between the first insulating strip 501 and the second insulating strip 502 is a fluid that can generate bubbles, and the shock wave energy generated by the bubbles can reach the wall of the balloon 2 without obstacles.

[0135] In an optional embodiment, at the first gap 303, a protrusion 3011a extending in the axial direction or radial direction is provided on the first end surface 3011; a groove 3022a extending in the axial direction or radial direction is provided at a corresponding position on the fourth end surface 3022; Figures 12 to 14 In the illustrated embodiment, the raised portion 3011a and the recessed portion 3022a extend axially. The raised portion 3011a on the first end surface 3011 and the recessed portion 3022a on the fourth end surface 3022 are adaptively matched in shape and can be triangular, trapezoidal, or arcuate. The raised portion 3011a on the first end surface 3011 and the recessed portion 3022a on the fourth end surface 3022 define a first gap 303 extending axially or radially therebetween. The area on the first end surface 3011 that contacts the insulating medium 5 is located outside the raised portion 3011a; the area on the fourth end surface 3022 that contacts the insulating medium 5 is located outside the recessed portion 3022a.

[0136] Similarly, at the second gap 304, a protrusion 3011a extending axially or radially is provided on the second end surface 3012; a groove 3022a extending axially or radially is provided at a corresponding position on the third end surface 3021. The protrusion 3011a on the second end surface 3012 and the groove 3022a on the third end surface 3021 can both be triangular, trapezoidal, or arcuate in shape. The protrusion 3011a on the second end surface 3012 and the groove 3022a on the third end surface 3021 define the second gap 304 extending axially or radially. The area of ​​the second end surface 3012 that contacts the insulating medium 5 is located outside the protrusion 3011a; the area of ​​the third end surface 3021 that contacts the insulating medium 5 is located outside the groove 3022a.

[0137] In this embodiment, the cooperation between the protrusion 3011a and the groove 3022a increases the area of ​​adjacent end surfaces for discharge, which is conducive to discharge between adjacent end surfaces of the electrodes.

[0138] In an optional embodiment, when both the first gap 303 and the second gap 304 of the proximal electrode pair 3b are provided with an insulating medium 5, the insulating medium 5 and the first proximal overlapping section 801b are located in the same gap of the proximal electrode pair 3b; when only one of the first gap 303 and the second gap 304 of the proximal electrode pair 3b is provided with an insulating medium 5, one of the insulating medium 5 and the first proximal overlapping section 801b is located in the first gap 303 of the proximal electrode pair 3b, and the other is located in the second gap 304 of the proximal electrode pair 3b.

[0139] When the insulating medium 5 and the first proximal overlapping section 801b are both located in the first gap 303 of the proximal electrode pair 3b:

[0140] In an alternative embodiment, if Figure 21 As shown, the radial width of the insulating medium 5 along the catheter 1 is smaller than the width of the first end face 3011, and the radial width of the insulating medium 5 along the catheter 1 is smaller than the width of the fourth end face 3022; and the insulating medium 5 is located between the first proximal overlapping section 801b and the outer wall of the catheter 1.

[0141] In another optional embodiment, the axial length of the insulating medium 5 along the catheter 1 is less than the length of the first end face 3011, and the axial length of the insulating medium 5 along the catheter 1 is less than the length of the fourth end face 3022; and a channel is provided on the insulating medium 5 that passes through the axial direction of the catheter 1; and the first proximal overlapping section 801b is provided in the channel.

[0142] In another alternative embodiment, Figure 22 As shown, the insulating medium 5 includes a first insulating strip 501 and a second insulating strip 502; wherein the first insulating strip 501 and the second insulating strip 502 are arranged radially and spaced apart along the catheter 1, and the first proximal overlapping section 801b is located between the first insulating strip 501 and the second insulating strip 502; or the first insulating strip 501 and the second insulating strip 502 are arranged axially and spaced apart along the catheter 1, and the first insulating strip 501 and the second insulating strip 502 are respectively provided with a channel passing through the axial direction of the catheter 1; the first proximal overlapping section 801b is provided in the channel between the first insulating strip 501 and the second insulating strip 502.

[0143] In another optional embodiment, a protrusion 3011a is provided on the first end surface 3011; a groove 3022a is provided at a corresponding position of the fourth end surface 3022; the area on the first end surface 3011 that contacts the insulating medium 5 is located outside the protrusion 3011a; the area on the fourth end surface 3022 that contacts the insulating medium 5 is located outside the groove 3022a; and the first proximal overlapping section 801b is located between the protrusion 3011a and the groove 3022a.

[0144] In an optional embodiment, a developing ring 7 is mounted on the outside of the catheter 1. Positioned within the balloon 2, the developing ring 7 is used to mark the position of the balloon 2 within the human body using an imaging system. Preferably, the developing ring 7 is positioned outside the electrode pair 3, rather than overlapping it, to prevent the catheter 1 from having a partially enlarged cross-section.

[0145] 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.

[0146] 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.

[0147] 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 catheter; sealing a balloon surrounding the circumference of the catheter; At least two electrode pairs are disposed within the balloon; each of the electrode pairs comprises a first electrode and a second electrode; The wire has an outer insulating layer; the electrode pair is electrically connected to a pulse voltage generator through the wire; the pulse voltage generator is used to provide a pulse voltage to the electrode pair; characterized in that: The first electrode and the second electrode are spaced apart along the circumference of the catheter; the first electrode includes a first end face located at one circumferential end of the catheter and a second end face located at the other circumferential end of the catheter; the second electrode includes a third end face located at one circumferential end of the catheter and a fourth end face located at the other circumferential end of the catheter; the first end face and the fourth end face are adjacent to each other and define a first gap; the second end face and the third end face are adjacent to each other and define a second gap; when the pulse voltage generator applies a pulse voltage between the first electrode and the second electrode, the first electrode and the second electrode are configured to form a discharge shock wave in at least one of the first gap and the second gap; The at least two electrode pairs include a distal electrode pair and a proximal electrode pair; the proximal electrode pair is located between the pulse voltage generator and the distal electrode pair; The wire includes a first wire connected between the pulse voltage generator and the distal electrode pair; the first wire includes a first proximal overlapping segment; the first proximal overlapping segment is located in the interval where the proximal electrode pair is located along the axial direction of the catheter; the first proximal overlapping segment is arranged in the first gap or the second gap of the proximal electrode pair.

2. The device according to claim 1, wherein: The wire connected between the pulse voltage generator and the distal electrode pair further includes a second wire; the second wire includes a second proximal overlapping section, and the second proximal overlapping section is located within the section where the proximal electrodes are located along the axial direction of the catheter; The first wire is electrically connected between the pulse voltage generator and the first electrode; the second wire is electrically connected between the pulse voltage generator and the second electrode; The first proximal overlapping section is arranged in the first gap of the proximal electrode pair; the second proximal overlapping section is arranged in the second gap of the proximal electrode pair; or The first proximal overlapping section and the second proximal overlapping section are both arranged in the first gap of the proximal electrode pair; or The first proximal overlapping segment and the second proximal overlapping segment are both disposed within the second gap of the proximal electrode pair.

3. The device according to claim 2, characterized in that: The first guide wire includes a first distal overlapping segment, and the first distal overlapping segment is located in the interval where the distal electrode pair is located along the axial direction of the catheter; the second guide wire includes a second distal overlapping segment, and the second distal overlapping segment is located in the interval where the distal electrode pair is located along the axial direction of the catheter; The first distal overlapping segment is disposed within the first gap of the distal electrode pair; the second distal overlapping segment is disposed within the second gap of the distal electrode pair; or The first distal overlapping segment and the second distal overlapping segment are both disposed within the first gap of the distal electrode pair; or The first distal overlapping segment and the second distal overlapping segment are both disposed within the second gap of the distal electrode pair.

4. The device according to claim 1, wherein: The wires connected between the pulse voltage generator and the proximal electrode pair include a third wire; the second electrode of the proximal electrode pair is electrically connected to the pulse voltage generator via the third wire; the first electrode of the proximal electrode pair is electrically connected to the second electrode of the distal electrode pair via a fourth wire; and the first electrode of the distal electrode pair is electrically connected to the pulse voltage generator via the first wire.

5. The device according to claim 4, characterized in that: The third guide wire includes a third proximal overlapping section, and the third proximal overlapping section is located within the interval where the proximal electrode is located along the axial direction of the catheter; The first proximal overlapping segment is disposed in the first gap of the proximal electrode pair; and the third proximal overlapping segment is disposed in the second gap of the proximal electrode pair.

6. The device according to claim 4, characterized in that: The fourth guide wire includes a fourth proximal overlapping segment, and the fourth proximal overlapping segment is located within the interval where the proximal electrode is located along the axial direction of the catheter; The first proximal overlapping segment is disposed in the first gap of the proximal electrode pair; and the fourth proximal overlapping segment is disposed in the second gap of the proximal electrode pair.

7. The device according to claim 5 or 6, characterized in that: The first guide wire includes a first distal overlapping segment, which is located in the interval where the distal electrode pair is located along the axial direction of the catheter; the fourth guide wire includes a fourth distal overlapping segment, which is located in the interval where the distal electrode pair is located along the axial direction of the catheter; The first distal overlapping segment is disposed in the first gap of the distal electrode pair; the fourth distal overlapping segment is disposed in the second gap of the distal electrode pair; or The first distal overlapping segment and the fourth distal overlapping segment are both disposed within the first gap of the distal electrode pair; or The first distal overlapping segment and the fourth distal overlapping segment are both disposed within the second gap of the distal electrode pair.

8. The device according to claim 1, wherein: The first proximal overlapping section is arranged in the first gap of the proximal electrode pair; the first proximal overlapping section is fixedly connected to the first end surface of the proximal electrode pair; the first proximal overlapping section is fixedly connected to the fourth end surface of the proximal electrode pair.

9. The device according to claim 1, wherein: A positioning member is also included; the positioning member is used to maintain the relative position between the electrode pair and the catheter.

10. The device according to claim 9, characterized in that: The positioning member includes a positioning sheath made of an insulating material and arranged on the periphery of the electrode.

11. The device according to claim 10, characterized in that: The positioning sleeve is formed by thermoplastic molding.

12. The device according to claim 10, wherein: The outer diameter of the cross section at the location of the electrode pair is less than 1.2 mm.

13. The device according to claim 10, wherein: The positioning sleeve is provided with a first discharge hole; the first discharge hole is located outside the gap between the first gap and the second gap where a discharge shock wave can be formed.

14. The device according to claim 10, wherein: The number of the electrode pairs is at least 2, and at least 2 of the electrode pairs are spaced apart along the axial direction of the catheter; One positioning sheath covers the outside of at least two electrode pairs.

15. The device according to claim 1, wherein: The inner wall of the first electrode and the inner wall of the second electrode are respectively attached to the outer wall of the catheter.

16. The device according to claim 1, wherein: An installation groove extending in a circumferential direction is provided on the outer wall of the tube body of the catheter; the electrode pair is arranged in the installation groove.

17. The device according to claim 1, wherein: In the first gap and the second gap of the proximal electrode pair, an insulating medium is provided at the gap where a discharge shock wave can be formed; The insulating medium and the first proximal overlapping section are located in the same gap of the proximal electrode pair, or one of the insulating medium and the first proximal overlapping section is located in the first gap of the proximal electrode pair, and the other is located in the second gap of the proximal electrode pair.

18. The device according to claim 17, wherein: The first electrode and the second electrode of the proximal electrode pair are configured to form a discharge shock wave in the first gap; the insulating medium is fixedly connected to the first end face, and the contact area between the two is smaller than the surface area of ​​the first end face; the insulating medium is fixedly connected to the fourth end face, and the contact area between the two is smaller than the surface area of ​​the fourth end face; the first proximal overlapping section is located in the first gap of the proximal electrode pair.

19. The device according to claim 18, characterized in that: The insulating medium has a radial width smaller than that of the first end face of the conduit, and a radial width smaller than that of the fourth end face of the conduit; and the insulating medium is located between the first proximal overlapping section and the outer wall of the conduit.

20. The device according to claim 18, wherein: The length of the insulating medium along the axial direction of the catheter is less than the length of the first end face, and the length of the insulating medium along the axial direction of the catheter is less than the length of the fourth end face; and a channel is provided on the insulating medium that passes through the axial direction of the catheter; the first proximal overlapping section is provided in the channel.

21. The device according to claim 18, wherein: The insulating medium includes a first insulating strip and a second insulating strip; wherein the first insulating strip and the second insulating strip are arranged at intervals along the radial direction of the catheter, and the first proximal overlapping section is located between the first insulating strip and the second insulating strip; or the first insulating strip and the second insulating strip are arranged at intervals along the axial direction of the catheter, and the first insulating strip and the second insulating strip are respectively provided with a channel passing through the axial direction of the catheter; the first proximal overlapping section is provided in the channel between the first insulating strip and the second insulating strip.

22. The device according to claim 18, wherein: A protrusion is provided on the first end surface; a groove is provided at a corresponding position on the fourth end surface; the area on the first end surface that contacts the insulating medium is located outside the protrusion; and the area on the fourth end surface that contacts the insulating medium is located outside the groove; The first proximal overlapping section is located between the protrusion and the groove.

23. A shock wave balloon catheter device comprising catheter; sealing a balloon surrounding the circumference of the catheter; A distal electrode pair and a proximal electrode pair are provided in the balloon; the proximal electrode pair is located between the pulse voltage generator and the distal electrode pair; the proximal electrode pair includes a first electrode and a second electrode; wire; The wire has an outer insulating layer; the distal electrode pair and the proximal electrode pair are respectively electrically connected to a pulse voltage generator through the wire; the pulse voltage generator is used to provide a pulse voltage to the distal electrode pair and the proximal electrode pair; and the characteristics are: The first electrode and the second electrode are spaced apart along the circumference of the catheter; the first electrode includes a first end face located at one circumferential end of the catheter and a second end face located at the other circumferential end of the catheter; the second electrode includes a third end face located at one circumferential end of the catheter and a fourth end face located at the other circumferential end of the catheter; the first end face and the fourth end face are adjacent to each other and define a first gap; the second end face and the third end face are adjacent to each other and define a second gap; when the pulse voltage generator applies a pulse voltage between the first electrode and the second electrode, the first electrode and the second electrode are configured to form a discharge shock wave in at least one of the first gap and the second gap; The wire includes a first wire connected between the pulse voltage generator and the distal electrode pair; the first wire includes a first proximal overlapping segment; the first proximal overlapping segment is located in the interval where the proximal electrode pair is located along the axial direction of the catheter; the first proximal overlapping segment is arranged in the first gap or the second gap of the proximal electrode pair.

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