Electrode device, forming method and shock wave system

Abstract

The present invention discloses an electrode device, a forming method and a shock wave system, which are arranged on a catheter and include at least one first electrode assembly, wherein the first electrode assembly includes a first outer electrode, a first insulating tube and at least two first inner electrodes arranged at intervals, wherein the first inner electrode and the first outer electrode are isolated by the first insulating tube; at least one end of the first insulating tube protrudes from the end surface of the first outer electrode along the axial direction of the catheter, and one end of the first inner electrode protrudes from the end surface of the first insulating tube along the axial direction; and a first discharge gap is provided between the first inner electrode and the first outer electrode. The present invention protrudes the first inner electrode axially from the first insulating tube, and the first insulating tube axially protrudes from the first outer electrode, increases the distance between the position of the first electrode assembly for electrical connection with the first wiring assembly and the first discharge gap, reduces the damage of the shock wave to the connection between the first electrode assembly and the first wiring assembly, prolongs the life of the electrode device, and improves the stability of shock wave release.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an electrode device, a forming method and a shock wave system. Background Art

[0002] Shock wave balloon technology is a new, safe and effective technology for treating heart valve and vascular calcification. It has the advantages of easy operation and balloon pre-expansion. During the treatment process, the shock wave balloon is pushed to the area to be treated through a catheter, and a medium is filled in the balloon so that the balloon surface contacts the area to be treated. Then the energy generator is turned on to make the electrodes in the balloon work and generate high-energy shock wave force. The high-energy shock wave force passes through the balloon surface into the area to be treated with calcified lesions, destroying the calcified structure and softening the area to be treated.

[0003] However, the structure of the shock wave electrode in the existing balloon still has many defects. Due to the limitation of the overall size of the shock wave balloon, the material on the electrode should be as thin as possible, which brings great challenges to the insulation strength of the electrode insulation layer and the life of the electrode; the holes in the existing electrodes lead to multiple weak points on the electrodes, which are difficult to withstand higher working voltages and are easily broken down; and when the electrodes are working, the layers of electrode materials will be ablated outward along the opening position. When the ablation reaches a certain extent, the electrode is damaged and cannot continue to discharge, resulting in the rapid exhaustion of the electrode life. Summary of the invention

[0004] In view of the problems existing in the above-mentioned prior art, the present invention provides an electrode device, a forming method and a shock wave system. The technical solution is as follows:

[0005] The present invention provides an electrode device, which is arranged on a catheter and comprises:

[0006] at least one first electrode assembly, the first electrode assembly comprising a first outer electrode, a first insulating tube and at least two first inner electrodes spaced apart, the first inner electrode and the first outer electrode being separated by the first insulating tube;

[0007] At least one end of the first insulating tube protrudes from the end surface of the first outer electrode along the axial direction of the catheter, and one end of the first inner electrode protrudes from the end surface of the first insulating tube along the axial direction; a first discharge gap is formed between the first inner electrode and the first outer electrode.

[0008] Furthermore, the first insulating tube is coated on the conduit, the first inner electrode is embedded between the conduit and the first insulating tube, and the first outer electrode is sleeved on the outer wall of the first insulating tube.

[0009] Furthermore, among the at least two first inner electrodes, some of the first inner electrodes protrude from the proximal end surface of the first insulating tube, and the remaining first inner electrodes protrude from the distal end surface of the first insulating tube.

[0010] Furthermore, two adjacent first inner electrodes are staggered in the circumferential direction of the catheter, and a central angle corresponding to the shortest interval between two adjacent first inner electrodes in the circumferential direction is 30° to 90°.

[0011] Furthermore, the electrode device comprises at least two groups of first electrode assemblies, and the first inner electrodes of the at least two groups of the first electrode assemblies are staggered in the circumferential direction of the catheter.

[0012] Furthermore, the electrode device further comprises at least one second electrode assembly, and the at least one first electrode assembly and the at least one second electrode assembly are spaced apart from each other in the axial direction.

[0013] Further, the second electrode assembly includes a second outer electrode, a second insulating tube and at least two second inner electrodes arranged at intervals, and the second inner electrode and the second outer electrode are isolated by the second insulating tube;

[0014] At least one end of the second insulating tube protrudes axially from the end surface of the second outer electrode, one end of the second inner electrode protrudes from the end surface of the second insulating tube, and a second discharge gap is defined between the second inner electrode and the second outer electrode.

[0015] Furthermore, one end of the second insulating tube close to the distal end protrudes axially from the end surface of the second outer electrode, and one end of the second inner electrode close to the distal end protrudes from the end surface of the second insulating tube to generate a shock wave force released toward the distal end.

[0016] Furthermore, the at least two second inner electrodes both protrude from the same end surface of the second insulating tube.

[0017] Furthermore, the shortest spacing between two adjacent second inner electrodes in the circumferential direction of the conduit is greater than the gap length of the second discharge gap, and the gap length of the second discharge gap is the minimum straight-line distance of the discharge path between the second inner electrode and the second outer electrode, and the discharge path passes through the end surface of the second insulating tube.

[0018] Furthermore, the electrode device also includes a first wiring assembly and a second wiring assembly isolated from each other, the first electrode assembly is electrically connected to a power source via the first wiring assembly, and the second electrode assembly is electrically connected to the power source via the second wiring assembly.

[0019] Further, the first wiring assembly is electrically connected to at least two first inner electrodes of the first electrode assembly, and one end of the first inner electrode located in the first insulating tube is electrically connected to the first wiring assembly;

[0020] The second wiring assembly is electrically connected to at least two second inner electrodes of the second electrode assembly, and one end of the second inner electrode located in the second insulating tube of the second electrode assembly is electrically connected to the second wiring assembly.

[0021] The present invention further provides a shock wave system, comprising a catheter, a balloon and an electrode device as described in any one of the above items, wherein the electrode device is arranged on the outer wall of the catheter and is located inside the balloon.

[0022] In another aspect, the present invention further provides a method for forming an electrode device, comprising:

[0023] Connecting at least two first inner electrodes to the catheter; at least two first inner electrodes are spaced apart from each other;

[0024] The first insulating tube is sleeved on the outer sides of the at least two first inner electrodes; one end of the first inner electrode protrudes out of the end surface of the first insulating tube along the axial direction of the conduit;

[0025] A first outer electrode is sleeved on the outer side of a first insulating tube, so that the first outer electrode, the first insulating tube and at least two first inner electrodes form a first electrode assembly to obtain an electrode device; the first inner electrode and the first outer electrode are isolated by the first insulating tube, at least one end of the first insulating tube protrudes from the end surface of the first outer electrode along the axial direction, and a first discharge gap is provided between the first inner electrode and the first outer electrode.

[0026] The implementation of the present invention has the following beneficial effects:

[0027] 1. In the first electrode assembly of the present invention, at least one end of the first insulating tube protrudes axially from the end surface of the first outer electrode, and one end of the first inner electrode protrudes axially from the end surface of the first insulating tube, so that the first discharge gap is formed at one end of the first electrode assembly in the axial direction, which can significantly increase the distance between the position where the first electrode assembly is used to connect with the first wiring assembly and the first discharge gap, reduce the damage to the connection between the first electrode assembly and the first wiring assembly caused by the shock wave force generated at the first discharge gap during use, greatly reduce the risk of the first wiring assembly breaking and failing at the connection, greatly extend the service life of the electrode device, and at the same time, help to improve the release stability of the shock wave force, and improve the effectiveness and safety of the electrode device and the shock wave system.

[0028] 2. The present invention arranges at least one second electrode assembly on the catheter, arranges the second inner electrode to protrude axially from the second insulating tube, and arranges the second insulating tube to protrude axially from the second outer electrode, forming a stepped protruding structure in the axial direction, so that when the second inner electrode and the second outer electrode are turned on, a shock wave force is generated that is released axially in a concentrated manner, which can open up a severely calcified area at the distal end of the electrode device. The expansion is simple and efficient, which is beneficial to improving the passability of the electrode device and the remaining proximal parts thereof, facilitating the electrode device to penetrate into the area to be treated, and improving the effectiveness, accuracy and stability of the electrode device in releasing the shock wave force to the area to be treated.

[0029] 3. In the present invention, the end of the second inner electrode close to the distal end protrudes from the end surface of the second insulating tube, so that the second electrode assembly can release the shock wave force forward at a position closer to the distal end, further reducing the distance between the shock wave force and the severely calcified area in the tissue, reducing the loss of the shock wave force during the transmission process, and increasing the intensity of the shock wave acting on the severely calcified tissue, which is beneficial to improving the expansion efficiency and expansion effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] In order to more clearly illustrate the technical solution of the present invention, the following is a brief introduction to the drawings used in the embodiments, wherein the same components are represented by the same reference numerals. Obviously, the drawings described below are only some embodiments of the present invention, and it is possible for ordinary technicians in this field to obtain other drawings based on these drawings without creative work.

[0031] Figure 1 A schematic diagram of the three-dimensional structure of an electrode device provided in an embodiment of the present invention;

[0032] Figure 2 A schematic diagram of the assembly structure of an electrode device provided by an embodiment of the present invention;

[0033] Figure 3 A schematic diagram of an assembly structure of a first electrode assembly provided by an embodiment of the present invention;

[0034] Figure 4 An exploded view of a first electrode assembly provided by an embodiment of the present invention;

[0035] Figure 5 An exploded view of a second electrode assembly provided by an embodiment of the present invention;

[0036] Figure 6 A schematic diagram of a connection structure between a first wiring assembly and a second wiring assembly provided by an embodiment of the present invention;

[0037] Figure 7 A schematic structural diagram of a shock wave system provided by an embodiment of the present invention;

[0038] Figure 8 is an electrical connection framework diagram of an electrode device in an exemplary embodiment of the present invention;

[0039] Fig. 9 is a schematic structural diagram of a shock wave system in another embodiment;

[0040] Fig.10 is an electrical connection framework diagram of an electrode device in another exemplary embodiment of the present invention;

[0041] Fig.11 is a schematic diagram of the three-dimensional structure of the electrode device in Example 4;

[0042] Fig.12 Schematic diagram of the test results of the maximum pulse discharge times of the electrode device in Example 4;

[0043] Fig.13 is a schematic diagram of detecting the peak pressure of a shock wave at a distance of 3 mm from the electrode device within the service life of the electrode device of Example 4;

[0044] Fig.14 This is a physical morphology diagram of the electrode device after its life is exhausted in Example 4;

[0045] Fig.15 The figure is a physical diagram of an electrode device in the prior art after its life is exhausted.

[0046] Among them, the reference numerals in the figure correspond to:

[0047] 1-catheter, 2-first electrode assembly, 21-first outer electrode, 22-first insulating tube, 23-first inner electrode, 3-second electrode assembly, 31-second outer electrode, 32-second insulating tube, 33-second inner electrode, 4-first wiring assembly, 5-second wiring assembly, 6-balloon. DETAILED DESCRIPTION

[0048] The technical solutions in the embodiments of the present invention will be described clearly and completely below in conjunction with the drawings in the embodiments of the present invention. It should be noted that the terms "upper", "lower", "left", "right", "inside", "outside", "front", "back", "two ends", "one end", "the other end" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for the convenience of describing the present invention, and do not indicate or imply that the device or structure referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention; and the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments in the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0049] In the prior art, the electrode assembly structure in the shock wave system has many defects, and the wiring components such as the wires used to conduct the circuit have poor mechanical impact resistance, which limits the life of the electrode device. The instantaneous high impact pressure and high temperature generated at the moment of shock wave release will damage the weak part of the wire, which is usually the connection position between the wire and the electrode. During the continuous discharge process, the damage to the weak part continues to accumulate until it breaks and fails, resulting in the inability of the electrode assembly to discharge, that is, the life is exhausted; for example, in some electrode assemblies, holes are opened on the electrodes, resulting in multiple structural weak points on the electrodes, which are difficult to withstand high working voltages and are easily broken down, affecting the life; in other electrode assemblies, in order to ensure the symmetry of the discharge point, the discharge point (or discharge gap) is usually placed in the center of the electrode assembly, so that the distance between the discharge point and the weak part of the wire is usually less than half the length of the electrode assembly. If the discharge point and the weak part of the wire are too close, the weak part of the wire will bear most of the mechanical impact force and heat brought by the shock wave, and the life of the electrode assembly will be sharply reduced.

[0050] In addition, there are some shock wave systems in which the balloon diameter is larger than the catheter diameter. In areas with severe calcification, especially in coronary and peripheral blood vessels, the space available for the balloon to pass through the calcified tissue is limited, making it difficult for the distal end of a conventional balloon to pass through, and even prone to forming an occluded section. Conventional balloon expansion is also very difficult, resulting in the catheter passing through but the balloon having difficulty passing through, and being unable to reach the area to be treated for treatment, which greatly limits the passability of the balloon and the therapeutic effect of the shock wave system.

[0051] In order to solve at least one of the above problems faced by the shock wave system, the present invention provides an electrode device, a forming method and a shock wave system, wherein: Figure 1 and Figure 2As shown, the electrode device is arranged on the catheter 1 of the shock wave system, and the electrode device is located inside the balloon 6 of the shock wave system. The electrode device includes at least one first electrode assembly 2, and the first electrode assembly 2 is mainly used to release the shock wave force toward the area to be treated after reaching the area to be treated, thereby softening the calcified tissue in the area to be treated and realizing precise treatment.

[0052] Specifically, Figure 3 and Figure 4 As shown, the first electrode assembly 2 includes a first outer electrode 21, a first insulating tube 22 and at least two first inner electrodes 23 arranged at intervals, and the first inner electrode 23 and the first outer electrode 21 are isolated by the first insulating tube 22; at least one end of the first insulating tube 22 protrudes axially from the end surface of the first outer electrode 21, and one end of the first inner electrode 23 protrudes from the end surface of the first insulating tube 22, and a first discharge gap is provided between the first inner electrode 23 and the first outer electrode 21; thus, the first electrode assembly 2 is connected to the power supply through the first wiring assembly 4 to achieve conduction, and the first discharge gap is located at one end of the first electrode assembly 2, allowing the first wiring assembly 4 to be connected to The other end of the first electrode assembly 2 is away from the first discharge gap, that is, the distance between the position where the first electrode assembly 2 is connected to the first wiring assembly 4 and the first discharge gap is significantly increased, thereby reducing the damage to the connection between the first electrode assembly 2 and the first wiring assembly 4 caused by the shock wave force generated at the first discharge gap during use, especially reducing the damage to the first wiring assembly 4, greatly reducing the risk of breakage and failure of the first wiring assembly 4 at the connection, greatly extending the service life of the electrode device, and at the same time, helping to improve the release stability of the shock wave force, and improving the effectiveness and safety of the electrode device and the shock wave system.

[0053] Specifically, Figure 1-2 As shown, the first insulating tube 22 is coated on the catheter 1, the first inner electrode 23 is embedded between the catheter 1 and the first insulating tube 22, and the first outer electrode 21 is sleeved on the outer wall of the first insulating tube 22, so that the first insulating tube 22 effectively isolates the first outer electrode 21 and the first inner electrode 23; in some exemplary embodiments, the first insulating tube 22 and the first inner electrode 23 are interference fit, so as to effectively isolate the first outer electrode 21 and the first inner electrode 23 while improving the limiting effect of the first insulating tube 22 on the first inner electrode 23, preventing the first inner electrode 23 from abnormally moving during operation, which is beneficial to improving the output stability of the shock wave system and also beneficial to extending the service life of the first electrode assembly 2 and the electrode device.

[0054] Specifically, Figure 2As shown, in some exemplary embodiments, one end of the first insulating tube 22 axially protrudes from the end surface of the first outer electrode 21, and the protruding end can be the distal end or the proximal end of the first outer electrode 21, and the other end is flush with the end surface of the first outer electrode 21, which can save material for the first insulating tube 22 and reduce costs. During assembly, it is only necessary to determine the lengths of the first insulating tube 22 and the first outer electrode 21, and one end can be aligned for assembly, thereby improving assembly convenience. In other exemplary embodiments, the two ends of the first insulating tube 22 respectively protrude axially from the end surfaces of the first outer electrode 21, so as to avoid the unexpected situation that the first outer electrode 21 axially protrudes from the first insulating tube 22 due to micro-movement during operation, thereby causing a short circuit with the first inner electrode 23 in an area outside the first discharge gap. This can greatly reduce the damage that the electrode device may suffer during use, and improve the working stability, reliability and durability of the first electrode assembly 2 and the electrode device.

[0055] Specifically, in some exemplary embodiments, the axial length of the protruding end of the first insulating tube 22 protruding from the first outer electrode 21 is 0 mm to 0.5 mm; it can be understood that the axial length of the protruding end of the first insulating tube 22 protruding from the first outer electrode 21 can be any point value between 0 mm and 0.5 mm; exemplarily, the axial length of the protruding end of the first insulating tube 22 protruding from the first outer electrode 21 can be 0 mm, 0.1 mm, 0.2 mm, 0.25 mm, 0.3 mm, 0.4 mm, 0.5 mm, etc.; in this way, the short circuit during operation can be effectively avoided, and the working stability, reliability and durability of the first electrode assembly 2 and the electrode device can be greatly improved; in some preferred embodiments, the axial length of the protruding end of the first insulating tube 22 protruding from the first outer electrode 21 is greater than 0 mm and less than 0.5 mm.

[0056] Specifically, in some exemplary embodiments, in the same first electrode assembly 2, two adjacent first inner electrodes 23 are staggered in the circumferential direction of the catheter 1, and the central angle corresponding to the shortest spacing between the two adjacent first inner electrodes 23 in the circumferential direction is 30°~90°; it can be understood that the central angle corresponding to the shortest spacing between the two adjacent first inner electrodes 23 in the circumferential direction can be any point value between 30° and 90°; exemplarily, the central angle corresponding to the shortest spacing between the two adjacent first inner electrodes 23 in the circumferential direction can be 30°, 45°, 50°, 55°, 60°, 75°, 80°, 90°, etc.; in this way, the spacing between the two first inner electrodes 23 can be increased, ensuring that the two first inner electrodes 23 cannot touch each other, thereby improving the discharge effectiveness and discharge accuracy of the first electrode assembly 2, and having good reliability and safety.

[0057] Specifically, in some exemplary embodiments, the axial length of the first inner electrode 23 is 1.0 mm to 2.0 mm; it can be understood that the axial length of the first inner electrode 23 can be any point value between 1.0 mm and 2.0 mm; in some exemplary embodiments, the length of the protruding section of the first inner electrode 23 protruding axially from the first insulating tube 22 is greater than 0.2 mm and less than 0.25 times the axial length of the first inner electrode 23; exemplarily, the axial length of the first inner electrode 23 is 2.0 mm, and the length of the protruding section of the first inner electrode 23 protruding axially from the first insulating tube 22 is greater than 0.2 mm and less than 0.5 mm; in this way, the discharge effectiveness and discharge reliability can be improved, and at the same time, it is beneficial to extend the service life of the first electrode assembly 2.

[0058] Specifically, Figure 2 As shown, the electrode device also includes a first wiring assembly 4, and the first electrode assembly 2 is electrically connected to the power supply through the first wiring assembly 4; the first wiring assembly 4 is electrically connected to at least one of the at least two first inner electrodes 23 to conduct the first electrode assembly 2; and, one end of the first inner electrode 23 located in the first insulating tube 22 is electrically connected to the first wiring assembly 4, that is, one end of the first inner electrode 23 away from the first discharge gap is electrically connected to the first wiring assembly 4, thereby increasing the distance from the first discharge gap to the connection of the first wiring assembly 4, reducing the damage to the connection of the first wiring assembly 4 caused by the shock wave force, which is beneficial to prolonging the life of the first wiring assembly 4, the first electrode assembly 2 and the electrode device as a whole, and is also beneficial to improving the discharge stability of the first electrode assembly 2 and the electrode device.

[0059] Specifically, Figure 4 As shown, in some exemplary embodiments, the first electrode assembly 2 includes at least two first inner electrodes 23 spaced apart from each other, and among the at least two first inner electrodes 23, some of the first inner electrodes 23 protrude from the proximal end surface of the first insulating tube 22, and the remaining first inner electrodes 23 protrude from the distal end surface of the first insulating tube 22, that is, first discharge gaps are respectively formed at both ends of the first electrode assembly 2, which is beneficial to disperse multi-point positioning treatment of multiple areas to be treated and enhance the axial treatment area of ​​the electrode device. In addition, the asymmetric discharge structure is beneficial to disperse the damage caused by the shock wave force to the connection of the first wiring assembly 4, which is beneficial to prolong the life of the electrode device.

[0060] Specifically, the first wiring assembly 4 is electrically connected to at least two first inner electrodes 23 of the first electrode assembly 2, and the connection between the first wiring assembly 4 and the first inner electrode 23 is located inside the first insulating tube 22, which can play a certain protective role on the first wiring assembly 4, and, as Figure 3As shown, the connection between the first inner electrode 23 and the first wiring assembly 4 is located at one end of the first inner electrode 23, which is far away from the end of the first inner electrode 23 for forming the first discharge gap, which can significantly increase the distance A between the first discharge gap and the connection of the first wiring assembly 4. The shock wave is severely attenuated in a short distance, and a small distance difference can produce a large shock wave difference, thereby greatly reducing the damage of the shock wave force to the connection of the first wiring assembly 4 during use, reducing the risk of the first wiring assembly 4 breaking and failing, and greatly extending the service life of the first wiring assembly 4; when the voltage is applied, at least two first inner electrodes 23 are connected to the power supply through the first wiring assembly 4, and the current passes through one first inner electrode 23, breaks through the liquid medium of one first discharge gap, and introduces the working current into the first outer electrode 21, and then breaks through the liquid medium of another first discharge gap, and introduces the working current into the other first inner electrode 23, so as to realize the conduction discharge of the first electrode assembly 2, thereby effectively treating the treatment area.

[0061] Specifically, at least two first inner electrodes 23 are spaced apart in the circumferential direction of the catheter 1, that is, the shortest circumferential spacing between two adjacent first inner electrodes 23 is greater than the gap length of the first discharge gap, so as to prevent abnormal breakdown in the non-discharge area between the first inner electrodes 23; and the first insulating tube 22 is interference fit with the first inner electrode 23, and is tightly attached to the internal catheter 1 in the circumferential area between the two adjacent first inner electrodes 23, which can also isolate the two adjacent first inner electrodes 23 to a certain extent, prevent abnormal breakdown, improve the discharge reliability of the first electrode assembly 2, and improve the safety of the treatment process.

[0062] Among them, the gap length of the first discharge gap is the minimum straight-line distance of the discharge path between the first inner electrode 23 and the first outer electrode 21, and its discharge path passes over the end face of the first insulating tube 22, so that when the voltage is turned on, the liquid medium at the first discharge gap can be effectively broken down, but it is not easy to break down the liquid medium in other non-discharge areas, thereby ensuring the accuracy and reliability of the discharge position and improving the treatment effect.

[0063] In some exemplary embodiments, the electrode device includes a first electrode assembly 2; in other exemplary embodiments, the electrode device includes at least two first electrode assemblies 2; thus, the first electrode assembly 2 is flexibly arranged and can be applied to a variety of different treatment scenarios and treatment needs.

[0064] In some exemplary embodiments, when the electrode device includes at least two first electrode assemblies 2, two adjacent first electrode assemblies 2 are insulated from each other in the axial direction, that is, the minimum axial spacing between at least one of the first outer electrode 21 and the first inner electrode 23 of one first electrode assembly 2 and at least one of the first outer electrode 21 and the first inner electrode 23 of the adjacent first electrode assembly 2 is greater than the gap length of the first discharge gap, so as to avoid abnormal breakdown in the non-discharge area outside the first discharge gap, which can not only improve the accuracy of the formation of the shock wave force, but also reduce the risk of abnormal damage to the first electrode assembly 2.

[0065] Specifically, Figure 2 As shown, in some exemplary embodiments, when the electrode device includes at least two first electrode assemblies 2, the first inner electrodes 23 of at least two groups of first electrode assemblies 2 are staggered in the circumferential direction of the catheter 1; further, the first inner electrodes 23 of two adjacent groups of first electrode assemblies 2 are staggered in the circumferential direction; during assembly, the first inner electrode 23 can be rotated to quickly adjust the orientation of the two adjacent first electrode assemblies 2, thereby adjusting the relative position of the first discharge gaps in the two adjacent first electrode assemblies 2, so that the first discharge gaps in the two adjacent first electrode assemblies 2 are also staggered in the circumferential direction, so as to perform multi-point and multi-directional discharge, which is convenient for treating intravascular calcification; exemplarily, the angle formed by the two adjacent groups of first electrode assemblies 2 around the central axis of the catheter 1 is 90°.

[0066] Specifically, Figure 1 and Figure 5 As shown, the electrode device includes at least one second electrode assembly 3, and the at least one second electrode assembly 3 is spaced apart from the at least one first electrode assembly 2 in the axial direction, that is, the first electrode assembly 2 and the second electrode assembly 3 are insulated from each other in the axial direction to avoid abnormal discharge interference; in addition, it should be noted that the second electrode assembly 3 is located at the distal end of the catheter 1 relative to the first electrode assembly 2, that is, the second electrode assembly 3 is relatively located at the head of the balloon 6, so as to provide a more concentrated axial shock wave force for expansion, so as to facilitate the balloon 6 to effectively open the severely calcified area to be treated.

[0067] The second electrode assembly 3 includes a second outer electrode 31, a second insulating tube 32 and at least two second inner electrodes 33 arranged at intervals. The second inner electrode 33 and the second outer electrode 31 are isolated by the second insulating tube 32, so that the second inner electrode 33 and the second outer electrode 31 are relatively insulated; and at least one end of the second insulating tube 32 protrudes from the end surface of the second outer electrode 31 along the axial direction of the catheter 1, and one end of the second inner electrode 33 protrudes from the end surface of the second insulating tube 32 along the axial direction, so that a second discharge gap is formed between the second inner electrode 33 and the second outer electrode 31, and the second discharge gap is the second inner electrode 33 axially extending from the end surface of the second insulating tube 32. The minimum distance between the portion protruding from the second insulating tube 32 and the end face of the second outer electrode 31; that is, in some embodiments, the shape of the first electrode assembly 2 is the same as the shape of the second electrode assembly 3; the second discharge gap in the second electrode assembly 3 is also located at one end of the second electrode assembly 3 in the axial direction, which can significantly increase the distance from the connection point of the second wiring assembly 5 used to conduct the second electrode assembly 3 to the second discharge gap, thereby reducing the risk of breakage and failure of the second wiring assembly 5 at the connection point, greatly extending the life of the electrode device, and at the same time, helping to improve the stability of the release of the shock wave force.

[0068] When voltage is applied to the second electrode assembly 3, the second electrode assembly 3 is in the liquid medium in the balloon 6, and the voltage can break through the liquid medium in the second discharge gap, so that the second inner electrode 33 is connected to the second outer electrode 31 through the part of the second insulating tube 32 that protrudes axially, generating a shock wave force that is at least partially released along the axial direction of the catheter 1, helping the distal end (or head) of the balloon 6 to expand the calcified area, so that the balloon 6 as a whole can pass through the calcified area and accurately reach the area to be treated, greatly improving the passability of the balloon 6 and the shock wave system, and thus helping to improve the accuracy and effectiveness of treating tissue calcification in the area to be treated.

[0069] Specifically, Figure 1 As shown, the second insulating tube 32 is covered on the conduit 1. Figure 2 As shown, the second inner electrode 33 is embedded between the catheter 1 and the second insulating tube 32, and the second outer electrode 31 is sleeved on the outer wall of the second insulating tube 32, so that the second insulating tube 32 effectively isolates the second outer electrode 31 and the second inner electrode 33; in some exemplary embodiments, the second insulating tube 32 and the second inner electrode 33 are interference fit, so as to effectively isolate the second outer electrode 31 and the second inner electrode 33 while improving the limiting effect of the second insulating tube 32 on the second inner electrode 33, preventing the second inner electrode 33 from abnormally moving during operation, which is beneficial to improving the output stability of the shock wave system and also beneficial to extending the service life of the second electrode assembly 3 and the electrode device.

[0070] In some exemplary embodiments, the material of the first insulating tube 22 and the second insulating tube 32 is a flexible material with high insulation properties; further, the material of the first insulating tube 22 and the second insulating tube 32 is a heat-shrinkable material with high insulation properties, such as polyethylene (PE); the flexible material has good elasticity, and on the one hand, it is convenient for sheathing and assembly, and on the other hand, it has good fastening, coating and filling effects, and can effectively prevent the first inner electrode 23 and the second inner electrode 33 from moving in the axial, circumferential and radial directions of the catheter 1, effectively maintain the structural stability and deformation resistance of the second electrode assembly 3 and the first electrode assembly 2 and the entire electrode device, and can also prevent abnormal discharge in the non-discharge area, thereby improving the durability and long-term effectiveness of the electrode device.

[0071] Specifically, in some exemplary embodiments, one end of the second insulating tube 32 axially protrudes from the end surface of the second outer electrode 31, and the protruding end can be the distal end or the proximal end of the second outer electrode 31, and the other end is flush with the end surface of the second outer electrode 31, which can save material of the second insulating tube 32 and reduce costs. During assembly, it is only necessary to determine the length of the second insulating tube 32 and the second outer electrode 31, and one end can be aligned for assembly, which greatly improves the convenience of assembly. In other exemplary embodiments, the two ends of the second insulating tube 32 respectively protrude axially from the end surfaces of the second outer electrode 31 to avoid the unexpected situation that the second outer electrode 31 axially protrudes from the second insulating tube 32 due to slight movement during operation, thereby causing a short circuit between the second inner electrode 33 and the second discharge gap. This can greatly reduce the damage that the electrode device may suffer during use, and improve the working stability, reliability and durability of the second electrode assembly 3 and the electrode device.

[0072] Specifically, in some exemplary embodiments, the axial length of the protruding end of the second insulating tube 32 protruding from the second outer electrode 31 is 0 mm to 0.5 mm; it can be understood that the axial length of the protruding end of the second insulating tube 32 protruding from the second outer electrode 31 can be any point value between 0 mm and 0.5 mm; exemplarily, the axial length of the protruding end of the second insulating tube 32 protruding from the second outer electrode 31 can be 0 mm, 0.1 mm, 0.2 mm, 0.25 mm, 0.3 mm, 0.4 mm, 0.5 mm, etc.; in this way, the short circuit during operation can be effectively avoided, and the working stability, reliability and durability of the second electrode assembly 3 and the electrode device can be greatly improved; in some preferred embodiments, the axial length of the protruding end of the second insulating tube 32 protruding from the second outer electrode 31 is greater than 0 mm and less than 0.5 mm.

[0073] Specifically, in some exemplary embodiments, the axial length of the second inner electrode 33 is 1.0 mm to 2.0 mm; it can be understood that the axial length of the second inner electrode 33 can be any point value between 1.0 mm and 2.0 mm; in some exemplary embodiments, the length of the protruding section of the second inner electrode 33 protruding axially from the second insulating tube 32 is greater than 0.2 mm and less than 0.25 times the axial length of the second inner electrode 33; exemplarily, the axial length of the second inner electrode 33 is 2.0 mm, and the length of the protruding section of the second inner electrode 33 protruding axially from the second insulating tube 32 is greater than 0.2 mm and less than 0.5 mm; in this way, the discharge effectiveness and discharge reliability can be improved, and at the same time, it is beneficial to extend the service life of the second electrode assembly 3.

[0074] Specifically, in some exemplary embodiments, the end of the second insulating tube 32 near the proximal end protrudes axially from the end surface of the second outer electrode 31, and the end of the second inner electrode 33 near the proximal end protrudes axially from the end surface of the second insulating tube 32, so as to generate an axial shock wave force at the end near the proximal end of the second electrode assembly 3, and the second electrode assembly 3 is located at the front end of the balloon 6. The second electrode assembly 3 itself is also relatively small in size. Even if an axial shock wave force is generated at the proximal end of the second electrode assembly 3, the axial shock wave force is generated at the distal end of the balloon 6, that is, it can be used to expand the calcified area blocked at the front end of the balloon 6.

[0075] Specifically, in some preferred embodiments, one end of the second insulating tube 32 near the distal end protrudes axially from the end surface of the second outer electrode 31, and one end of the second inner electrode 33 near the distal end protrudes from the end surface of the second insulating tube 32 to generate a shock wave force released toward the distal end. Then, at the front end of the balloon 6, the distance between the shock wave force and the area to be expanded can be further shortened, and the transmission loss of the shock wave force can be reduced, so that the shock wave force reaching the area to be expanded still retains a relatively high intensity, which is beneficial to enhancing the effectiveness and efficiency of expansion and saving operation time.

[0076] Specifically, Figure 2 As shown, the electrode device also includes a second wiring assembly 5, and the second electrode assembly 3 is electrically connected to the power supply through the second wiring assembly 5; the second wiring assembly 5 is electrically connected to at least one of the at least two second inner electrodes 33 to conduct the second electrode assembly 3; and, one end of the second inner electrode 33 located in the second insulating tube 32 is electrically connected to the second wiring assembly 5, that is, one end of the second inner electrode 33 away from the second discharge gap is electrically connected to the second wiring assembly 5, thereby increasing the distance from the second discharge gap to the connection of the second wiring assembly 5, reducing the damage to the connection of the second wiring assembly 5 caused by the shock wave force, which is beneficial to prolonging the life of the second wiring assembly 5, the second electrode assembly 3 and the electrode device as a whole, and is also beneficial to improving the discharge stability of the second electrode assembly 3 and the electrode device.

[0077] Specifically, Figure 5 As shown, in some exemplary embodiments, the second electrode assembly 3 includes at least two second inner electrodes 33 arranged at intervals, and at least two second inner electrodes 33 protrude from the same end surface of the second insulating tube 32 to form a second discharge gap with the at least two second inner electrodes 33 on the same end surface of the second outer electrode 31; and, each second inner electrode 33 forms a second discharge gap with the second outer electrode 31 for fixed-point discharge, which is beneficial to reduce the discharge discreteness of the second electrode assembly 3, so that the generated shock wave force is more concentrated, and has a stronger shock wave force along the axial direction to expand the calcified area, thereby improving the passability of the shock wave system balloon; in addition, the second insulating tube 32 can form a fastening limit for the at least two second inner electrodes 33, without the need to further add a limit structure, which is beneficial to simplifying the structure of the second electrode assembly 3 and improving the convenience of assembly.

[0078] Specifically, the second wiring assembly 5 is electrically connected to at least two second inner electrodes 33 of the second electrode assembly 3, and the connection between the second wiring assembly 5 and the second inner electrode 33 is located inside the second insulating tube 32, which can play a certain protective role on the second wiring assembly 5, and the connection between the second inner electrode 33 and the second wiring assembly 5 is located at one end of the second inner electrode 33, which is far away from the end of the second inner electrode 33 for forming the second discharge gap, which can significantly increase the distance between the second discharge gap and the connection between the second wiring assembly 5, and greatly reduce the damage to the connection of the second wiring assembly 5 caused by the shock wave force during use. When voltage is applied, at least two second inner electrodes 33 are connected to the power supply through the second wiring assembly 5, and the current passes through one second inner electrode 33, breaks through the liquid medium of the second discharge gap, and introduces the working current into the second outer electrode 31, and then breaks through the liquid medium of another second discharge gap, and introduces the working current into the other second inner electrode 33, so as to realize the conduction discharge of the second electrode assembly 3, thereby effectively expanding the calcified occlusion area at the distal end of the balloon 6, and improving the passability of the shock wave system with the second electrode assembly 3.

[0079] Specifically, at least two second inner electrodes 33 are spaced apart in the circumferential direction of the catheter 1, that is, the shortest spacing between two adjacent second inner electrodes 33 in the circumferential direction is greater than the gap length of the first discharge gap, so as to prevent abnormal breakdown of the non-discharge area between the second inner electrodes 33; and the second insulating tube 32 is interference fit with the second inner electrode 33, and is tightly attached to the internal catheter 1 in the circumferential area between the two adjacent second inner electrodes 33, which can also isolate the two adjacent second inner electrodes 33 to a certain extent, prevent abnormal breakdown, improve the discharge reliability of the second electrode assembly 3, and also help to generate axially released shock wave force between the second inner electrode 33 and the second outer electrode 31, thereby effectively exerting the expansion effect of the second electrode assembly 3.

[0080] Among them, the gap length of the second discharge gap is the minimum straight-line distance of the discharge path between the second inner electrode 33 and the second outer electrode 31, and its discharge path passes over the end face of the second insulating tube 32, so that when the voltage is turned on, the liquid medium at the second discharge gap can be effectively broken down, and it is not easy to break down the liquid medium in other non-discharge areas, ensuring that the formed shock wave force has at least an axial component, thereby improving the discharge accuracy and discharge stability for effective expansion; in addition, it should be noted that the shock wave force generated at the second discharge gap is released in multiple directions, and not only has an axial component, but also has circumferential and radial components. The second electrode assembly 3 uses the axial component of the shock wave force to concentrate on expansion, thereby greatly improving the passability of the balloon 6 with the second electrode assembly 3 in calcified tissue.

[0081] In some exemplary embodiments, the electrode device includes a second electrode assembly 3; in other exemplary embodiments, the electrode device includes at least two second electrode assemblies 3; in this way, the second electrode assembly 3 is flexibly arranged and can be applicable to severely calcified areas with different degrees of blockage and a variety of different treatment scenarios.

[0082] In some exemplary embodiments, when the electrode device includes at least two second electrode assemblies 3, two adjacent second electrode assemblies 3 are insulated from each other in the axial direction, that is, the minimum axial spacing between at least one of the second outer electrode 31 and the second inner electrode 33 of one second electrode assembly 3 and at least one of the second outer electrode 31 and the second inner electrode 33 of the adjacent second electrode assembly 3 is greater than the gap length of the second discharge gap; further, the minimum axial spacing between the adjacent second electrode assemblies 3 and the first electrode assembly 2, and between the second inner electrode 33 (and the second outer electrode 31) and the adjacent first outer electrode 21 or the first inner electrode 23 are also greater than the first discharge gap and the second discharge gap, so as to avoid abnormal breakdown in the non-discharge area outside the first discharge gap and the second discharge gap, improve discharge accuracy, and reduce the risk of abnormal damage to the electrode device.

[0083] In addition, in some optional embodiments, the gap lengths of the first discharge gap and the second discharge gap may be equal or different, and accordingly, the voltage applied to the second electrode assembly 3 and the voltage applied to the first electrode assembly 2 may be equal or different to adapt to different application scenarios and requirements.

[0084] Specifically, Figure 6 As shown, the first wiring assembly 4 and the second wiring assembly 5 are isolated from each other so that the first electrode assembly 2 and the second electrode assembly 3 can be controlled separately; wherein, at least one first electrode assembly 2 forms a first electrical circuit through the first wiring assembly 4, and at least one second electrode assembly 3 forms a second electrical circuit through the second wiring assembly 5, and the first electrical circuit and the second electrical circuit can be controlled separately, so that the first electrode assembly 2 and the second electrode assembly 3 can work separately without affecting each other, thereby improving the control accuracy.

[0085] Specifically, Figure 6 As shown, the first wiring assembly 4 includes at least a first positive electrode line and a first negative electrode line, and the second wiring assembly 5 includes at least a second positive electrode line and a second negative electrode line, wherein the first positive electrode line and the second positive electrode line are respectively connected to different positive power supply interfaces, and / or the first negative electrode line and the second negative electrode line are respectively connected to different negative power supply interfaces, so as to respectively control the first electrode assembly 2 and the second electrode assembly 3; illustratively, the first positive electrode line and the second positive electrode line are connected to the same positive power supply interface, and the first negative electrode line and the second negative electrode line are respectively connected to different negative power supply interfaces.

[0086] In addition, in some exemplary embodiments, the first wiring assembly 4 and the second wiring assembly 5 can share the same positive power supply interface, or share the same negative power supply interface. The present invention does not make specific limitations on this, as long as the electrode device can be turned on.

[0087] Specifically, in some exemplary embodiments, when the electrode device includes at least two first electrode assemblies 2 spaced apart in the axial direction, at least two first electrode assemblies 2 are connected in series and / or in parallel through a first wiring assembly 4 to extend the circumferential length of the first electrode assembly 2 acting on the area to be treated and expand the treatment range of the electrode device; the first wiring assembly 4 also includes a first transition wiring, and both ends of the first transition wiring are respectively electrically connected to two adjacent first electrode assemblies 2 to effectively conduct the two adjacent first electrode assemblies 2.

[0088] Specifically, in some exemplary embodiments, when the electrode device includes at least two second electrode assemblies 3 spaced apart in the axial direction, at least two second electrode assemblies 3 are connected in series and / or in parallel through a second wiring assembly 5 to enhance the strength of the shock wave force in the axial direction and improve the expansion efficiency and expansion effect; the second wiring assembly 5 also includes a second transition wiring, and both ends of the second transition wiring are respectively electrically connected to two adjacent second electrode assemblies 3 to effectively conduct the two adjacent second electrode assemblies 3.

[0089] Optionally, the number of first electrode assemblies 2 can be 1 to 7, and the number of second electrode assemblies 3 can be 1 to 5. The combination is flexible and can be applied to a variety of different treatment needs with good applicability. Exemplarily, the number of first electrode assemblies 2 is 3, and the corresponding globe capsule 6 is shorter, which is suitable for treating coronary calcification with a smaller calcification length; Exemplarily, the number of first electrode assemblies 2 is 4 or 5, and the corresponding globe capsule 6 is longer, which is suitable for treating peripheral vascular calcification with a longer calcification length.

[0090] Specifically, Figure 7 As shown, the shock wave system provided by the present invention includes a catheter 1, a balloon 6 and the electrode device as described above, wherein the electrode device is arranged on the outer wall of the catheter 1, and the electrode device is located in the balloon 6; wherein the catheter 1 passes through the inner wall of the first inner electrode 21 and the inner wall of the second inner electrode 31, and the material of the catheter 1 can be selected from an alloy material having both shape memory and a certain rigidity, such as nickel-titanium alloy, so that the electrode device and the shock wave system can smoothly reach the area to be treated under the guidance of the catheter 1 and the expansion of the second electrode assembly 3; the interior of the balloon 6 is a cavity structure, and the cavity structure is used to accommodate the electrode device, the catheter 1 and a liquid medium, and the liquid medium is a liquid that can be punctured by discharge and generate a shock wave force, and is preferably physiological saline, a mixed solution of physiological saline and contrast agent, silicone oil, etc.

[0091] Specifically, Fig. 9 As shown, the length of the catheter 1 is greater than the length of the balloon 6, the distal end of the balloon 6 is sealed and connected to the catheter 1 to prevent leakage of the liquid medium, the inner diameter of the proximal end of the balloon 6 is greater than or equal to the outer diameter of the electrode device, and it is convenient to assemble the electrode device into the balloon 6, and the first wiring assembly 4 and the second wiring assembly 5 are led out from the proximal end of the balloon 6 and connected to a power source.

[0092] When the balloon 6 of the shock wave system has difficulty passing through a blocked area, a voltage is applied to the second electrode assembly 3 through the second wiring assembly 5. The voltage passes through a second inner electrode 33 to break through the liquid medium of a second discharge gap. The working current is introduced into the second outer electrode 31 through the second discharge gap. Then the voltage breaks through the liquid medium of another second discharge gap. The working current is introduced into another second inner electrode 33 through the second discharge gap, and finally flows back to the negative pole of the power supply through the second negative electrode line. In this process, the second electrode assembly 3 generates a shock wave force that is at least partially released toward the distal axial direction, which can effectively expand the blocked area at the front end of the balloon 6, making it easier for the balloon 6 to pass through and reach the area to be treated.

[0093] After reaching the area to be treated, a voltage is applied to the first electrode assembly 2 through the first wiring assembly 4.

[0094] The voltage passes through a first inner electrode 23, breaks down the liquid medium of a first discharge gap, and the working current is introduced into the first outer electrode 21 through the first discharge gap. Then the voltage breaks down the liquid medium of another first discharge gap, and the working current is introduced into another first inner electrode 23 through the first discharge gap, and finally flows back to the negative pole of the power supply through the first negative electrode line, so that the first electrode assembly 2 is turned on to generate a shock wave force for treating the area to be treated; after the treatment is completed, the balloon catheter is depressurized and withdrawn to complete the treatment process.

[0095] On the other hand, an embodiment of the present invention further provides a method for forming an electrode device, comprising:

[0096] S1, connecting at least two first inner electrodes to a catheter; at least two of the first inner electrodes are spaced apart from each other;

[0097] S2, sleeve the first insulating tube onto the outer sides of the at least two first inner electrodes; one end of the first inner electrode protrudes out of the end surface of the first insulating tube along the axial direction of the conduit;

[0098] S3, a first outer electrode is sleeved on the outer side of the first insulating tube, so that the first outer electrode, the first insulating tube and at least two first inner electrodes form a first electrode assembly to obtain an electrode device; the first inner electrode and the first outer electrode are isolated by the first insulating tube, at least one end of the first insulating tube protrudes from the end surface of the first outer electrode along the axial direction, and a first discharge gap is provided between the first inner electrode and the first outer electrode.

[0099] The method for forming the electrode device is simple and convenient, and only three steps are required to form a first electrode assembly. If there are multiple first electrode assemblies in the electrode device, the above steps S1 to S3 can be repeated to form multiple first electrode assemblies, which is convenient to assemble and has high assembly accuracy.

[0100] Furthermore, the second electrode assembly can also be formed by the same process, including connecting at least two second inner electrodes to the catheter, and the at least two second inner electrodes are spaced apart from each other; then the second insulating tube is sleeved on the outside of the at least two second inner electrodes, and one end of the second inner electrode protrudes out of the end surface of the second insulating tube along the axial direction of the catheter; finally, the second outer electrode is sleeved on the outside of the second insulating tube, so that the second outer electrode, the second insulating tube and the at least two second inner electrodes form a second electrode assembly, and an electrode device having a second electrode assembly is obtained. The formation method of the second electrode assembly is simple and convenient, and the assembly efficiency is high.

[0101] The specific embodiments of the present invention are described below in combination with the above specific implementation modes.

[0102] Example 1

[0103] like Figure 1 and Figure 6 As shown, the shock wave system provided in this embodiment includes a catheter 1, a balloon 6 and an electrode device located in the balloon 6, and the balloon 6 is filled with a liquid medium that can be penetrated, and the electrode device includes a second electrode assembly 3, the second electrode assembly 3 includes a second outer electrode 31, a second insulating tube 32 and two second inner electrodes 33, the second insulating tube 32 is sleeved on the catheter 1, the two second inner electrodes 33 are embedded between the catheter 1 and the second insulating tube 32, and the second outer electrode 31 is sleeved on the outer wall of the second insulating tube 32; and, the two ends of the second insulating tube 32 protrude from the two end faces of the second outer electrode 31 along the axial direction of the catheter 1, and the ends of the two second inner electrodes 33 close to the distal end both protrude from the end face of the second insulating tube 32 along the axial direction, then there is a second discharge gap between the second inner electrode 33 and the second outer electrode 31, which can generate a shock wave force toward the distal end and released along the axial direction, thereby effectively expanding the occluded area and improving the passability of the balloon 6.

[0104] Specifically, the two second inner electrodes 33 are spaced apart in the circumferential direction, and the shortest distance between two adjacent second inner electrodes 33 in the circumferential direction is greater than the gap length of the second discharge gap to prevent abnormal breakdown of the non-discharge region between the second inner electrodes 33 .

[0105] Specifically, the electrode device also includes three first electrode assemblies 2 connected in series, and the first electrode assemblies 2 and the second electrode assemblies 3 are spaced apart in the circumferential direction; the first electrode assembly 2 includes a first outer electrode 21, a first insulating tube 22 and two first inner electrodes 23, the first insulating tube 22 is sleeved on the catheter 1, the two first inner electrodes 23 are embedded between the catheter 1 and the first insulating tube 22, and the first outer electrode 21 is sleeved on the outer wall of the first insulating tube 22; and the two ends of the first insulating tube 22 protrude from the two end surfaces of the first outer electrode 21 along the axial direction of the catheter 1, respectively, of the two first inner electrodes 23, one end of the first inner electrode 23 close to the distal end protrudes from the distal end surface of the first insulating tube 22 along the axial direction, and the other end of the first inner electrode 23 close to the proximal end protrudes from the proximal end surface of the first insulating tube 22 along the axial direction, and a first discharge gap is provided between the first inner electrode 23 and the first outer electrode 21, so that the first electrode assembly 2 can release the shock wave force for treatment, and at the same time can have a longer life and better shock wave release stability.

[0106] Specifically, the two first inner electrodes 23 are spaced apart in the circumferential direction, and the shortest spacing between two adjacent first inner electrodes 23 in the circumferential direction is greater than the gap length of the first discharge gap, so as to prevent abnormal breakdown of the non-discharge area between the first inner electrodes 23; in addition, the proximal end face of the second inner electrode 31 and the proximal end face of the second inner electrode 33 and the first inner electrode 23 of the adjacent first electrode assembly 2 and the first outer electrode 21 The shortest axial spacing is greater than the first discharge gap and the second discharge gap, further avoiding abnormal breakdown in the non-discharge area and improving the discharge reliability.

[0107] Specifically, the first inner electrodes 23 of two adjacent groups of first electrode assemblies 2 are staggered in the circumferential direction, so that the first discharge gaps in two adjacent first electrode assemblies 2 are also staggered in the circumferential direction to perform multi-point and multi-directional discharge, which is convenient for treating intravascular calcification.

[0108] Specifically, the electrode device includes a first wiring assembly 4, which is used to electrically connect the first electrode assembly 2 to a power source; Figure 6 and Figure 8 As shown, three first electrode assemblies 2 are connected in series, a first inner electrode 23 of the first first electrode assembly 2 is connected to the positive electrode of the power supply through a first positive electrode line, another first inner electrode 23 of the first electrode assembly 2 is connected to a first inner electrode 23 of an adjacent first electrode assembly 2 through a first transition connection, and another first inner electrode 23 of the adjacent first electrode assembly 2 is connected to a first inner electrode 23 of the third first electrode assembly 2 through another first transition connection, and another first inner electrode 23 of the third first electrode assembly 2 is connected to the negative electrode of the power supply through a second negative electrode line.

[0109] Specifically, the electrode device also includes a second wiring assembly 5 for electrically connecting the second electrode assembly 3 and the power supply, and the first wiring assembly 4 and the second wiring assembly 5 are isolated from each other so that the second electrode assembly 3 and the first electrode assembly 2 can be controlled separately and individually, thereby improving the control accuracy; wherein the second wiring assembly 5 includes a second positive electrode line and a second negative electrode line, the second positive electrode line is connected to a second inner electrode 33, and another second inner electrode 33 is connected to the first negative electrode line, and the second positive electrode line is connected to the first inner electrode 23 connected to the positive pole of the power supply among the three first electrode assemblies 2 (that is, a first inner electrode 23 connected to the first positive electrode line in the first first electrode assembly 2), so that the second electrode assembly 3 and the first electrode assembly 2 share a common positive pole of the power supply, thereby reducing the complexity of wiring, and at the same time will not affect the separate control of the second electrode assembly 3 and the first electrode assembly 2.

[0110] Example 2

[0111] The difference between this embodiment and embodiment 1 is that Fig. 9 and Fig.10 As shown, the electrode device includes four first electrode assemblies 2 , and the four electrode assemblies 3 are connected in series to further extend the treatment range of the first electrode assembly 2 .

[0112] Example 3

[0113] The difference between this embodiment and embodiment 1 is that the electrode device includes two second electrode assemblies 3 connected in series, wherein the second inner electrode 33 of one second electrode assembly 3 is connected to the positive electrode of the power supply (or the first inner electrode 23 in the first electrode assembly 2 connected to the positive electrode of the power supply) through a second positive electrode line, and the other second inner electrode 33 of the second electrode assembly 3 is connected to the second inner electrode 33 of another second electrode assembly 3 through a second transition connection, and the other second inner electrode 33 of the other second electrode assembly 3 is connected to the negative electrode of the power supply through a second negative electrode line, so as to effectively conduct the two second electrode assemblies 3, accurately expand the occluded area, and improve the passability of the balloon 6.

[0114] Example 4

[0115] The difference between this embodiment and embodiment 1 is that Fig.11 As shown, the electrode device includes two first electrode assemblies 2 connected in series; the rest is the same as the first embodiment.

[0116] Using the electrode device of this embodiment, three samples were randomly selected to test the life span and shock wave release stability. The life span of the electrode device composed of two electrode assemblies connected in series in the prior art is usually less than 150 pulses. Fig.12As shown in FIG. 1 , the three samples of this embodiment can achieve more than 1000 pulse discharge times. Compared with the electrode device of the prior art, the life of the electrode device of this embodiment is greatly extended; and Fig.13 As shown, during the above-mentioned 1000 or more discharge processes, that is, within the life of the electrode device, the three samples can release stable shock wave forces, which greatly improves the discharge stability and safety of the electrode device and the shock wave system having the electrode device.

[0117] Further, the electrode devices in this embodiment and the prior art are analyzed after their life is exhausted, such as Fig.14 and Fig.15 As shown, the failure mode of the first electrode assembly 2 of the present embodiment is mainly manifested in the first outer electrode 21. Excessive discharge ablation causes the first discharge gap to be too large, which in turn causes discharge difficulties. However, the weak positions inside the first electrode assembly 2 involving circuit conduction, namely, the connection between the first inner electrode 23 and the first wiring assembly 4, do not show serious damage. It can be seen that compared with the electrode device in the prior art, the electrode device provided in the embodiment of the present invention has the advantages of long service life and good discharge stability.

[0118] What is described above are only some embodiments of the present invention and are not intended to limit the present invention. Those skilled in the art should understand that the present invention may be subject to various changes and improvements, and any modifications, equivalent substitutions and improvements made in accordance with the present invention shall fall within the scope of protection required by the present invention.

Claims

1. An electrode device, arranged on a catheter (1), characterized in that: include: At least one first electrode assembly (2), at least one second electrode assembly (3) connected in parallel with the first electrode assembly (2), a first wiring assembly (4) and a second wiring assembly (5) isolated from each other, the at least one first electrode assembly (2) and the at least one second electrode assembly (3) being arranged spaced apart in the axial direction, the first electrode assembly (2) being electrically connected to a power source via the first wiring assembly (4), and the second electrode assembly (3) being electrically connected to the power source via the second wiring assembly (5); The first electrode assembly (2) comprises a first outer electrode (21), a first insulating tube (22), and at least two first inner electrodes (23) arranged at intervals in the circumferential direction, wherein the first inner electrode (23) and the first outer electrode (21) are isolated by the first insulating tube (22); At least one end of the first insulating tube (22) protrudes from the end surface of the first outer electrode (21) along the axial direction of the catheter (1); among the at least two first inner electrodes (23), some of the first inner electrodes (23) protrude from the proximal end surface of the first insulating tube (22), and the remaining first inner electrodes (23) protrude from the distal end surface of the first insulating tube (22), and only one end of the first inner electrode (23) protrudes from the first insulating tube (22); a first discharge gap is formed between the end surface portion of the first inner electrode (23) protruding from the first insulating tube (22) and the end surface of the first outer electrode (21); The second electrode assembly (3) comprises a second outer electrode (31), a second insulating tube (32), and at least two second inner electrodes (33) arranged at intervals in the circumferential direction, wherein the second inner electrode (33) and the second outer electrode (31) are isolated by the second insulating tube (32); At least one end of the second insulating tube (32) protrudes axially from the end surface of the second outer electrode (31), one end of the second inner electrode (33) protrudes from the end surface of the second insulating tube (32), and a second discharge gap is provided between the second inner electrode (33) and the second outer electrode (31); and only one end of the second inner electrode (33) protrudes from the second insulating tube (32); One end of the second insulating tube (32) close to the distal end protrudes axially from the end surface of the second outer electrode (31), and one end of the second inner electrode (33) close to the distal end protrudes from the end surface of the second insulating tube (32), forming a second discharge gap with the distal end surface of the second outer electrode (31); The at least two second inner electrodes (33) both protrude from the same end surface of the second insulating tube (32); The first wiring assembly (4) comprises a first positive electrode line, a first negative electrode line and a first transition line, a plurality of the first electrode assemblies (2) are connected in series, a first inner electrode (23) of the first first electrode assembly (2) is connected to the positive electrode of the power supply via the first positive electrode line, another first inner electrode (23) of the first first electrode assembly (2) is connected to a first inner electrode (23) of an adjacent first electrode assembly (2) via the first transition line, another first inner electrode (23) of an adjacent first electrode assembly (2) is connected to a first inner electrode (23) of another adjacent or last first electrode assembly (2) via another first transition line, and another first inner electrode (23) of the last first electrode assembly (2) is connected to the negative electrode of the power supply via the first negative electrode line; The first transition wire, the first negative electrode wire and the first inner electrode (23) connected thereto are electrically connected via one end of the first inner electrode (23) located inside the first insulating tube (22); The second wiring assembly (5) comprises a second positive electrode line and a second negative electrode line, wherein the second positive electrode line is connected to one of the second inner electrodes (33), another second inner electrode (33) is connected to the second negative electrode line, and the second positive electrode line is connected to the first inner electrode (23) connected to the positive electrode of a power source among the plurality of first electrode assemblies (2), so that the second electrode assemblies (3) and the first electrode assemblies (2) share a common positive electrode of the power source; The second positive electrode line, the second negative electrode line and the second inner electrode (33) connected thereto are electrically connected via one end of the second inner electrode (33) located inside the second insulating tube (32).

2. The electrode device according to claim 1, characterized in that The first insulating tube (22) is coated on the conduit (1), the first inner electrode (23) is embedded between the conduit (1) and the first insulating tube (22), and the first outer electrode (21) is sleeved on the outer wall of the first insulating tube (22).

3. The electrode device according to claim 1, characterized in that Two adjacent first inner electrodes (23) are staggered in the circumferential direction of the catheter (1), and the center angle corresponding to the shortest spacing between two adjacent first inner electrodes (23) in the circumferential direction is 30° to 90°.

4. The electrode device according to claim 1, characterized in that The electrode device comprises at least two groups of first electrode assemblies (2), and the first inner electrodes (23) of the at least two groups of the first electrode assemblies (2) are staggered in the circumferential direction of the catheter (1).

5. The electrode device according to claim 1, characterized in that The shortest distance between two adjacent second inner electrodes (33) in the circumferential direction of the conduit (1) is greater than the gap length of the second discharge gap, and the gap length of the second discharge gap is the minimum straight-line distance of a discharge path between the second inner electrode (33) and the second outer electrode (31), and the discharge path passes through the end surface of the second insulating tube (32).

6. A shock wave system, characterized in that: It comprises a catheter (1), a balloon (6), and an electrode device according to any one of claims 1 to 5, wherein the electrode device is arranged on the outer wall of the catheter (1), and the electrode device is located inside the balloon (6).

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