Shock wave electrodes and shock wave balloon catheters

Abstract

The present invention provides a shock wave electrode and a shock wave balloon catheter. The shock wave electrode comprises a first electrode and a second electrode which are arranged at intervals and extend in the same direction; the first electrode has a first distal surface, and the second electrode has a second distal surface; when the first distal surface and the second distal surface are located in a conductive liquid and a voltage is applied to the first electrode and the second electrode, a shock wave can be triggered only between the first distal surface and the second distal surface. The shock wave balloon catheter comprises the shock wave electrode. The shock wave electrode and the shock wave balloon catheter of the present application can withstand a higher applied voltage, stably generate shock waves with a sufficient number of times and a stronger single shock wave energy, have a sufficiently large single shock wave energy and cumulative shock wave energy, and can achieve the treatment of hardened tissues in parts that cannot or are inconvenient to expand without the aid of expansion, using only shock wave energy, so as to soften these hardened tissues and restore some tissue functions.

Description

Technical Field

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

[0002] When the shock wave encounters a situation where the acoustic impedance of two adjacent materials is greatly different during propagation, a strong interaction will occur at the interface between the two. When the shock wave is transmitted from liquid or liquid-like soft tissue to solid tissue (such as calcified tissue in blood vessels), it will have a strong interaction with the solid tissue at the conduction interface, and continue to propagate and gradually attenuate in the liquid or liquid-like soft tissue medium. Within the appropriate energy range, the damage effect of the shock wave energy on the soft tissue can be ignored. The interaction between the shock wave and the solid tissue includes compression, shearing, stretching, cavitation effect and extrusion, which makes the solid tissue loose or cracks. Considering safety and controllability, the most widely used in the medical field is the liquid-electric shock wave. The basic principle of the occurrence of the liquid-electric shock wave is to load a high voltage (potential difference) to the electrode in a liquid medium (conductive liquid) with a certain conductivity, and generate an instantaneous discharge of a large current within a few microseconds. During the discharge process, a high-energy-density, high-temperature, high-pressure plasma zone is formed on the discharge channel, causing the discharge channel to expand rapidly and forming a pressure pulse in the liquid medium, that is, a shock wave. In addition to generating shock waves, part of the electrical energy is converted into heat and light during the discharge process.

[0003] Current shock wave catheters are used to loosen or crack calcified diseased tissue in coronary or peripheral blood vessels, and then expand them by inflating a balloon, thereby alleviating the stenosis of the blood vessels or facilitating subsequent treatment. Shock wave catheters have been marketed and their safety and effectiveness have been fully verified. However, existing shock wave balloon catheters are still unable to achieve treatment for hardened tissue (such as calcified diseased tissue) in areas that cannot or are inconvenient to expand (such as the mitral valve and aortic valve of the human body). Summary of the invention

[0004] In view of this, the present invention provides a shock wave electrode and a shock wave balloon catheter to achieve the purpose of using shock wave energy to treat hardened tissue in a part that cannot or is inconvenient to expand.

[0005] An embodiment of the present invention provides a shock wave electrode, comprising a first electrode and a second electrode which are arranged at an interval and extend in the same direction; the first electrode has a first distal surface, and the second electrode has a second distal surface; when the first distal surface and the second distal surface are located in a conductive liquid and a voltage is applied to the first electrode and the second electrode, a shock wave can be induced only between the first distal surface and the second distal surface.

[0006] The present invention also provides a shock wave balloon catheter, comprising the above-mentioned shock wave electrode, a tube body and an expansion element that can be filled with conductive liquid; the expansion element is sealed and connected to the distal end of the tube body, and the first distal end surface and the second distal end surface of the shock wave electrode are both located in the expansion element; when the expansion element is filled with conductive liquid and a voltage is applied to the first electrode and the second electrode of the shock wave electrode, a shock wave can be induced only between the first distal end surface and the second distal end surface.

[0007] Compared with the prior art, the beneficial effects that can be achieved by at least one of the above-mentioned technical solutions adopted in the embodiments of this specification include at least the following: the shock wave electrode of the present application can withstand a higher applied voltage, stably generate shock waves with a sufficient number of times and stronger single shock wave energy, and have a sufficiently large single shock wave energy and cumulative shock wave energy, so as to achieve the treatment of hardened tissues in parts that cannot or are inconvenient to expand without the help of expansion, using only shock wave energy, so as to soften these hardened tissues and restore some tissue functions. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for use in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0009] Figure 1 is a three-dimensional schematic diagram of the first structure in the first embodiment of the present application;

[0010] Figure 2 is an axial projection schematic diagram of the second structure in the first embodiment of the present application;

[0011] Figure 3 is an axial projection schematic diagram of the third structure in the first embodiment of the present application;

[0012] Figure 4 is an axial projection schematic diagram of the first structure in the second embodiment of the present application;

[0013] Figure 5 is an axial projection schematic diagram of the second structure in the second embodiment of the present application;

[0014] Figure 6 is an axial projection schematic diagram of the third structure in the second embodiment of the present application;

[0015] Figure 7 is an axial projection schematic diagram of the fourth structure in the second embodiment of the present application;

[0016] Figure 8is an axial projection schematic diagram of the fifth structure in the second embodiment of the present application;

[0017] Fig. 9 yes Figure 8 Theoretical schematic diagram of the energy variation of a single shock wave for the structure shown;

[0018] Fig.10 It is a schematic axial projection diagram of a structure of the third embodiment of the present application;

[0019] Fig.11 yes Fig.10 Theoretical schematic diagram of the energy variation of a single shock wave for the structure shown;

[0020] Fig.12 is an axial projection schematic diagram of the first structure in the fourth embodiment of the present application;

[0021] Fig.13 is an axial projection schematic diagram of the second structure in the fourth embodiment of the present application;

[0022] Fig.14 It is a schematic axial projection diagram of a structure of the fifth embodiment of the present application;

[0023] Fig.15 is a three-dimensional schematic diagram of a first structure in a first type of embodiment of the present application having an insulating portion;

[0024] Fig.16 is an axial projection schematic diagram of the second structure in the first embodiment of the present application having an insulating portion;

[0025] Fig.17 is an axial projection schematic diagram of the third structure in the first embodiment of the present application having an insulating portion;

[0026] Fig.18 is an axial projection schematic diagram of the first structure in the second embodiment of the present application having an insulating portion;

[0027] Fig.19 is an axial projection schematic diagram of a second structure in a second type of embodiment with an insulating portion of the present application;

[0028] Fig. 20 is an axial projection schematic diagram of the third structure in the second embodiment of the present application having an insulating portion;

[0029] Fig.21 is an axial projection schematic diagram of the fourth structure of the second embodiment with an insulating portion of the present application;

[0030] Fig. 22 is an axial projection schematic diagram of the fifth structure in the second embodiment of the present application having an insulating portion;

[0031] Fig.23 is an axial projection schematic diagram of a structure of the third embodiment of the present application having an insulating portion;

[0032] Fig.24 is an axial projection schematic diagram of the first structure in the fourth embodiment of the present application having an insulating portion;

[0033] Fig.25 is an axial projection schematic diagram of the second structure in the fourth embodiment of the present application having an insulating portion;

[0034] Fig.26 is an axial projection schematic diagram of a structure of the fifth embodiment of the present application having an insulating portion;

[0035] Fig. 27 It is a structural schematic diagram of a preferred embodiment of the present application;

[0036] Fig.28 It is a partial structural schematic diagram of an embodiment of a blind-end balloon of a shock wave balloon catheter of the present application.

[0037] Reference numerals in the figures:

[0038] 10. First electrode; 11. First distal surface; 1101. First segment of first distal surface; 1102. Second segment of first distal surface; 1103. Third segment of first distal surface; 20. Second electrode; 21. Second distal surface; 211. First sub-electrode segment; 212. Second sub-electrode segment; 213. Third sub-electrode segment; 2101. First segment of second distal surface; 2102. Second segment of second distal surface; 2103. Third segment of second distal surface; 2104. Fourth segment of second distal surface; 30. Expansion element; 40. Insulation part; 41. Distal surface; 50. Fluid inlet cavity; 60. Fluid discharge cavity; 70. Insulation member; 80. Tube body; 100. Shock wave electrode; 200. Shock wave balloon catheter. DETAILED DESCRIPTION

[0039] The embodiments of the present application are described in detail below with reference to the accompanying drawings.

[0040] The following describes the implementation methods of the present application through specific examples, and those skilled in the art can easily understand other advantages and effects of the present application from the contents disclosed in this specification. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. The present application can also be implemented or applied through other different specific implementation methods, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present application. It should be noted that, in the absence of conflict, the following embodiments and the features in the embodiments can be combined with each other. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in the field without making creative work belong to the scope of protection of the present application.

[0041] Since the shock wave balloon catheter of the prior art is only used to form cracks on the tissue to be treated with a tubular structure (such as coronary arteries and peripheral blood vessels), the shock wave generating device is very easy to be close to the tissue to be treated, and the distance between the shock wave generating device and the hardened tissue of the lesion is very close, and the utilization rate of the shock wave energy is high. Therefore, the shock wave electrode of the prior art only needs to provide shock waves with fewer initiation times and lower single energy, that is, to obtain lower single shock wave energy and cumulative shock wave energy, so as to form cracks on the tissue to be treated in the blood vessel. However, even if the utilization rate of the shock wave energy of the tissue to be treated with a tubular structure is higher, higher single shock wave energy and cumulative shock wave energy are still helpful for the treatment of the tissue to be treated. However, a higher applied voltage means a faster electrode melting and ablation speed (during the discharge breakdown process). Since the existing shock wave electrode is constrained by its own design characteristics, when the shock wave electrode of the prior art is connected to a higher applied voltage, the electrode is rapidly melted and ablated, and the distal end of the shock wave electrode presents a concave structure, and the material generated by the electrode melting and ablation is accumulated in the concave structure, thereby causing the shock wave electrode of the prior art to fail rapidly. Therefore, the shock wave electrode of the present application aims to enable the electrode to withstand a sufficiently high applied voltage and form a sufficient number of discharge breakdowns through structural changes, so as to obtain stable shock waves with sufficient frequency and sufficient single energy, and then obtain sufficiently large single shock wave energy and cumulative shock wave energy, so as to achieve the purpose of using shock wave energy to treat hardened tissue in areas that cannot or are inconvenient to expand, and solve the problem that hardened tissue in the lesion area cannot be treated using the shock wave balloon catheter of the prior art or cannot be treated using the shock wave balloon catheter of the prior art in combination with the expansion device.

[0042] Based on the shock wave electrode of the present application, the inventor of the present application has found through a large number of shock wave energy test studies that, when other conditions remain unchanged, the discharge distance, electrode exposed area and applied voltage have the following relationship with the single shock wave energy. Among them, the discharge distance refers to the electrical gap between the two electrodes (when the two electrodes are only insulated by air) or the creepage distance (when there is an insulator between the two electrodes that affects the electrical gap), the electrode exposed area refers to the exposed area of ​​the electrode in the air (without insulation performance, used to generate shock waves), the single shock wave energy refers to the shock wave energy released by a single shock wave, and the cumulative shock wave energy refers to the total shock wave energy released during the entire discharge breakdown process of the shock wave electrode. The "discharge distance remains unchanged" here means that the electrode distance hardly changes during the entire breakdown process.

[0043] 1. The discharge distance and the exposed area of ​​the electrode remain unchanged: when the applied voltage is small, no shock wave is generated; when the applied voltage reaches the first value, the electrode begins to discharge and break down to form a shock wave; the applied voltage continues to increase, and the energy of a single shock wave increases with the increase in the applied voltage, but the increase in the energy of a single shock wave is not proportional to the increase in the applied voltage, and the increase in the energy of a single shock wave is small; when the applied voltage reaches the second value, the increase in the energy of a single shock wave is significantly reduced, but the duration of the discharge breakdown to form a shock wave is shortened. Here, the first value is defined as the minimum breakdown voltage, and the second value is defined as the maximum effective voltage;

[0044] 2. Only the exposed area of ​​the electrode remains unchanged: the greater the discharge distance, the greater the minimum breakdown voltage, and at the same time, the greater the energy of the single shock wave formed by the discharge breakdown; vice versa;

[0045] 3. The exposed area of ​​the electrode and the applied voltage remain unchanged: when the discharge distance is large, no shock wave is generated; the discharge distance gradually decreases until the electrode begins to discharge and break down to form a shock wave. The smaller the discharge distance, the smaller the energy of a single shock wave.

[0046] 4. When the discharge distance remains unchanged, the smaller of the exposed areas of the electrodes has an impact on the discharge breakdown of the electrodes: as the exposed area of ​​the smaller electrode increases, the minimum breakdown voltage of the electrode discharge breakdown increases; however, the impact of the smaller exposed area of ​​the electrode on the minimum breakdown voltage is much smaller than the impact of the discharge distance on the minimum breakdown voltage;

[0047] 5. Discharge distance and applied voltage remain unchanged: When the applied voltage is greater than the minimum breakdown voltage and less than the maximum effective voltage, the larger the exposed area of ​​the smaller electrode, the longer the time for the discharge breakdown to form a shock wave, and the greater the energy of a single shock wave, and vice versa;

[0048] 6. The single shock wave energy when the electrode with a smaller exposed area is the positive electrode is greater than the single shock wave energy when the electrode with a smaller exposed area is the negative electrode.

[0049] It can be seen from this that if one wants to achieve the purpose of using shock wave energy to treat hardened tissue in areas that are unable or inconvenient to expand, it is necessary to obtain sufficiently large single shock wave energy and cumulative shock wave energy. Based on the above findings, it can be learned that this requires the electrode to be able to withstand a sufficiently high applied voltage and form a sufficient number of discharge breakdowns, so that a stable shock wave with sufficient number of times and sufficient single energy can be obtained during multiple discharge breakdown processes.

[0050] like Figures 1 to 27 As shown, an embodiment of the present invention provides a shock wave electrode 100, comprising a first electrode 10 and a second electrode 20 which are arranged at intervals and extend in the same direction; the first electrode 10 has a first distal surface 11, and the second electrode 20 has a second distal surface 21; when the first distal surface 11 and the second distal surface 21 are located in a conductive liquid and a voltage is applied to the first electrode 10 and the second electrode 20, a shock wave can be induced only between the first distal surface 11 and the second distal surface 21.

[0051] In this article, "distal end" refers to the end away from the operator, and "proximal end" refers to the end close to the operator. The shock wave electrode 100 of the present application generates a shock wave at the distal surface. The extension direction of the second electrode 20 is the same as the extension direction of the first electrode 10, which only means that the first electrode 10 and the second electrode 20 both extend between the proximal end and the distal end, and it is not necessary for the extension direction of the second electrode 20 to be parallel to the extension direction of the first electrode 10. The sides of the first electrode 10 and the second electrode 20 in the extension direction are insulated from each other, and the insulation strength value is greater than the applied voltage value; the first distal surface 11 of the first electrode 10 and the second distal surface 21 of the second electrode 20 are non-insulated. When the first electrode 10 and the second electrode 20 are subjected to the applied voltage, the sides of the first electrode 10 and the second electrode 20 in the extension direction do not discharge and break down, and only the corresponding potential difference is generated between the first distal surface 11 and the second distal surface 21, and the discharge and breakdown generate shock waves.

[0052] The following is a brief description of the discharge breakdown process of the shock wave electrode 100 of the present application. The first distal face 11 is a set of points A (including points A1, A2, ...An), and the second distal face 21 is a set of points B (including points B1, B2, ...Bn). The first electrode 10 and the second electrode 20 are electrically connected to a high-voltage pulse power supply, and a first potential difference is generated between the first electrode 10 and the second electrode 20. Discharge and breakdown occur between the two points A1 and B1 that are closest to the first distal face 11 and the second distal face 21, and electrical energy is rapidly converted into heat energy to form a first shock wave, and A1 and B1 are ablated and rapidly form a molten material. The changes of the first distal surface 11 and the second distal surface 21 are as follows: 1) The first distal surface 11 is ablated at A1 and the second distal surface 21 is ablated at B1 to form a depression. At the location of this depression, the distance between the first distal surface 11 and the second distal surface 21 increases; 2) The conductivity of the melt formed by the ablation of A1 and B1 is much lower than that of the electrode itself. Therefore, it is difficult for the melt to discharge and break down to generate shock waves, or the energy intensity of the shock waves generated by the barely broken down discharge is not enough to have a therapeutic effect. Therefore, when the second potential difference is generated between the first electrode 10 and the second electrode 20, if A2 and B2 are the two points closest to the first distal surface 11 and the second distal surface 21 at this time, discharge and breakdown occur between A2 and B2, and electrical energy is quickly converted into heat energy to form a second shock wave, and so on. Therefore, increasing the ablation area of ​​the first distal surface 11 and the second distal surface 21 at the same time can trigger more shock waves.

[0053] Therefore, the shock wave electrode 100 of the present application sets the location where the shock wave occurs at the distal surface, so that the first distal surface 11 of the first electrode 10 and the second distal surface 21 of the second electrode 20 can be set as surface structures, the first distal surface 11 can be set as a plane or a curved surface, and the second distal surface 21 can be set as a plane or a curved surface; according to the target value of a single shock wave energy, the first distal surface 11 and the second distal surface 21 both have a suitable exposed area, that is, the first electrode 10 and the second electrode 20 can obtain a sufficiently large effective melting volume. From the above-mentioned discharge breakdown process of the shock wave electrode 100 of the present application, it can be known that: 1) a larger effective melting volume allows a sufficiently far electrode distance to be set between the first distal end face 11 and the second distal end face 21, so that when a sufficiently high applied voltage is applied to the first electrode 10 and the second electrode 20, a shock wave with a stronger single shock wave energy is obtained in a single discharge breakdown process; and, 2) when a shock wave is generated under the same applied voltage, a larger effective melting volume allows the first distal end face 11 and the second distal end face 21 to stably withstand more times of melting and ablation, thereby having more shock wave initiation times, and stably obtaining shock waves with a sufficient number of times and a sufficiently strong single shock wave energy. Therefore, the shock wave electrode 100 of the present application can withstand a sufficiently high applied voltage for a sufficient number of times, obtain a sufficiently large single shock wave energy and cumulative shock wave energy at a suitable electrode distance, and achieve the purpose of using shock wave energy to treat hardened tissue in a part that cannot or is inconvenient to expand.

[0054] As a spherical wave, the shock wave propagates radially outward from the shock wave generating position within the range of the shock wave electrode 100 toward the distal end, and the shock wave energy with a therapeutic effect is defined as effective shock wave energy. The relative position between the two electrodes that form the shock wave by discharge breakdown will affect the propagation direction of the shock wave, thereby affecting the distribution form of the effective shock wave energy in space. When the second electrode 20 is spaced outside the first electrode 10, the first distal end face 11 and the second distal end face 21 are located in the same cross section of the shock wave electrode 100, or when the first electrode 10 and the second electrode 20 are spaced side by side, and the first distal end face 11 and the second distal end face 21 are located in the same cross section of the shock wave electrode 100, the distribution form of the effective shock wave energy in space is hemispherical. When the second electrode 20 is sleeved outside the first electrode 10 at intervals, the first distal surface 11 is located at the distal end of the second distal surface 21, or when the first electrode 10 and the second electrode 20 are arranged side by side at intervals, the electrode closer to the axis of the shock wave electrode 100 is located at the distal end of the other electrode (for example, when the distance between the first distal surface 11 and the axis of the shock wave electrode 100 is less than the distance between the second distal surface 21 and the axis of the shock wave electrode 100, the first distal surface 11 is located at the distal end of the second distal surface 21), the distribution form of the effective shock wave energy in space is a form larger than a hemisphere. It can be seen that by changing the relative position of the first distal surface 11 and the second distal surface 21 in space, the distribution form of the effective shock wave energy in space can be effectively adjusted, so as to obtain an effective shock wave energy coverage range with a distribution form of a hemispherical shape or even larger than a hemispherical shape, so that the shock wave energy covers as much as possible all hardened tissues in the parts near the shock wave electrode 100 that cannot or are inconvenient to expand, thereby achieving the purpose of treatment.

[0055] In a specific embodiment, the distal end surface of the shock wave electrode 100 is a plane or a convex surface, and the first distal end surface 11 and the second distal end surface 21 are located on the plane or the convex surface. By changing the relative positions of the first distal end surface 11 and the second distal end surface 21 on the plane or the convex surface, an effective shock wave energy coverage range with a distribution form of hemispherical or even larger than hemispherical is obtained, so that the shock wave energy covers as much as possible all hardened tissues in the parts near the shock wave electrode 100 that cannot or are inconvenient to expand, thereby achieving the purpose of treatment. When the distal end surface of the shock wave electrode 100 is a convex surface, it is preferred that the convex surface is an axisymmetric convex surface structure so that the effective shock wave energy can be relatively evenly distributed in space. The convex surface can be, for example, a spherical cap, a truncated cone, an ellipsoid, or a rotating parabola. In order to obtain higher single shock wave energy, the electrode corresponding to the smaller of the area of ​​the first distal surface 11 and the area of ​​the second distal surface 21 is the positive electrode. When the area of ​​the first distal surface 11 is smaller than the area of ​​the second distal surface 21, the first electrode 10 is the positive electrode; when the area of ​​the second distal surface 21 is smaller than the area of ​​the first distal surface 11, the second electrode 20 is the positive electrode.

[0056] In order to enable the electrodes to withstand the large amount of heat and impact generated in the process of generating shock waves, the material of the first electrode 10 and the material of the second electrode 20 in the embodiment of the present invention are preferably high temperature resistant and impact resistant materials, such as stainless steel, tungsten, tungsten alloy, titanium, titanium alloy, platinum, platinum alloy and other alloys, so that the first electrode 10 and the second electrode 20 can withstand higher applied voltages and stably generate more shock waves with stronger single shock wave energy.

[0057] In addition, the prior art achieves insulation between electrodes through a polymer insulating layer. The heat generated by the formation of the shock wave can melt the polymer insulating layer or even degrade and carbonize it. At the same time, under the action of thermal energy, the molten material formed by the ablation of the electrode and the molten material formed by the combustion of the polymer insulating layer mix with each other to form a mixture with extremely weak conductivity. In the absence of a significant increase in the potential difference, these mixtures cannot achieve breakdown discharge. In order to prevent the molten material produced after the electrode melts from reducing the electrical properties of the electrode, and the molten material from being conductive or the molten material produced after the polymer insulating layer melts, resulting in the inability to continue to discharge and break down, the shock wave electrode 100 of the present application is also provided with an insulating portion 40 between the first electrode 10 and the second electrode 20, and the insulating portion 40 has a distal surface 41. Preferably, the insulating portion 40 is filled between the first electrode 10 and the second electrode 20, Figures 15 to 26 Shown Figures 1 to 14The schematic diagram of the structure of the shock wave electrode 100 of the present application in the specific embodiment shown has an insulating part 40. The insulating part 40 is made of an insulating material with high breakdown strength (tolerating more discharge breakdowns under a sufficiently high applied voltage), high heat resistance (bearing more heat during the discharge breakdown process), high resistivity (sufficiently small influence on the discharge breakdown between the first distal end face 11 and the second distal end face 21), and high mechanical strength (able to withstand all impact forces during the entire discharge breakdown process). Since the heat and impact strength generated when the discharge breakdown forms a shock wave are very large, the insulating part 40 is preferably selected from insulating materials with higher values ​​of these performance indicators, and the higher the values ​​of the performance indicators, the better. For example, it can be existing ceramics or minerals (such as artificial diamonds), bakelite (a kind of plastic, chemical name is phenolic plastic), modified impact-resistant glass (existing, such as lead-added modification), quartz, or special ceramics that are modified to be more resistant to high temperatures, easier to process, and more impact-resistant. With the development of materials, if there are other materials with higher values ​​of performance indicators, the insulating part 40 can also be used. Therefore, during the process of generating the shock wave, the insulating portion 40 will not generate a melt, and will not generate a mixture containing a melt.

[0058] In the axial projection of the shock wave electrode 100 of the present application, the distal surface 41 is flush with the first distal surface 11, flush with the second distal surface 21, or located between the first distal surface 11 and the second distal surface 21. When the first distal surface 11 and the second distal surface 21 are discharged and broken down to form a shock wave, the shock wave is formed on the distal surface 41. The distal surface 41 can be a plane or a convex surface. By changing the shape of the distal surface of the insulating portion 40, the following are achieved: 1) a more precise discharge distance is provided between the first distal surface 11 and the second distal surface 21; for example, the discharge distance between the first distal surface 11 and the second distal surface 21 can be made longer by the insulating portion 40. The invention discloses a method for producing a shock wave electrode 100 of the present invention in a manner that is substantially equal to each other, and obtains a more stable single shock wave energy while maintaining a stable potential difference between the first electrode 10 and the second electrode 20; 2) utilizing the reflection effect of the distal end surface of the insulating portion 40 on the shock wave to more accurately adjust the distribution of the shock wave energy in space; 3) the molten material produced by electrode ablation cannot remain between the first electrode 10 and the second electrode 20, but is washed away under the impact force of the shock wave on the distal end surface of the shock wave electrode 100 of the present invention, and has a self-cleaning function, which completely solves the problem that the molten material accumulates on the electrode surface to reduce the electrical properties of the electrode, and the molten material conducts and causes the inability to continue to discharge and break down. Therefore, through the insulating portion 40, the influence of the electrode melting and the melting of the polymer insulating layer on the discharge distance in the prior art, as well as the unknown and unpredictable influence of the shock wave on the spatial distribution of the shock wave energy in the prior art, can be basically avoided, and a single shock wave energy and cumulative shock wave energy closer to the expected, as well as a shock wave energy spatial distribution closer to the expected, can be obtained. For example, when the distal surface of the insulating portion 40 is a plane, the shock wave energy caused by the distal ends of the first electrode 10 and the second electrode 20 is transmitted outward in a hemispherical shape of approximately 180°. When the distal surface of the insulating portion 40 is a convexity, especially a spherical crown convexity, the shock wave energy caused by the distal ends of the first electrode 10 and the second electrode 20 will be transmitted outward in a spherical crown shape greater than 180° due to the reflection effect of the distal surface of the insulating portion 40. It can be seen that the insulating portion 40 will constrain the direction of the shock wave, and the direction of the shock wave can be controlled by controlling the thickness, height and surface shape of the insulating portion 40. However, those skilled in the art should be able to imagine that the surface of the insulating portion 40 can be slightly lower than the lower of the first distal surface 11 and the second distal surface 21, which is basically the same as the surface of the insulating portion 40 being substantially level with the lower of the first distal surface 11 and the second distal surface 21, and the technical effect is not much different. The surface of the first distal end surface 11 and the second distal end surface 21 that is closer to the proximal end of the shock wave electrode 100 of the present application is the lower one. The height of the insulating portion 40 can be obtained through experimental testing.

[0059] As can be seen from the foregoing, by changing the discharge distance between the first distal end face 11 and the second distal end face 21, the energy of a single shock wave can be controlled. Specifically, the discharge distance between the first distal end face 11 and the second distal end face 21 is at least one of equal, continuously increasing, and step-increasing. Since the shock wave is formed between the two points closest to the first distal end face 11 and the second distal end face 21, the discharge breakdown process in which the discharge distance between the first distal end face 11 and the second distal end face 21 is continuously reduced is the same as the discharge breakdown process in which the discharge distance between the first distal end face 11 and the second distal end face 21 is continuously increased, and the discharge breakdown process in which the discharge distance between the first distal end face 11 and the second distal end face 21 is stepped reduced is the same as the discharge breakdown process in which the discharge distance between the first distal end face 11 and the second distal end face 21 is stepped increased.

[0060] When the discharge distance between the first distal face 11 and the second distal face 21 is equal, if the applied voltage is constant, the magnitude of the single shock wave energy remains basically unchanged. As long as the first electrode 10 and the second electrode 20 are subjected to a suitable applied voltage, any two points closest to the first distal face 11 and the second distal face 21 will discharge and break down and quickly melt after the shock wave is formed. If it is expected to obtain the target cumulative shock wave energy in a shorter time, a higher applied voltage can be applied if the single shock wave energy meets the safety requirements. Here, "suitable applied voltage" means that the applied voltage is greater than the minimum breakdown voltage between the first distal face 11 and the second distal face 21 and less than the maximum effective breakdown voltage between the first distal face 11 and the second distal face 21. The "higher applied voltage" here also needs to meet the range of "suitable applied voltage".

[0061] When the discharge distance between the first distal surface 11 and the second distal surface 21 is continuously increased, if the applied voltage is constant and the applied voltage is greater than the minimum breakdown voltage of all discharge distances and less than the maximum effective voltage of all discharge distances, it can be understood that the interval between the discharge breakdown to form the shock wave is getting longer and longer, and the energy of a single shock wave is getting larger and larger.

[0062] When the discharge distance between the first distal surface 11 and the second distal surface 21 increases in steps, if the applied voltage is constant and the applied voltage is greater than the minimum breakdown voltage of all discharge distances that increase in steps and less than the maximum effective voltage of all discharge distances that increase in steps, it can be understood that the interval time for the discharge breakdown to form a shock wave will increase in steps, and the energy of a single shock wave will also increase in steps.

[0063] In summary, the spatial distribution form and size of the effective shock wave energy can be adjusted by changing the spatial relative position and discharge distance between the first distal end surface 11 and the second distal end surface 21. Therefore, the discharge distance between the first distal end surface 11 and the second distal end surface 21 can be set according to the requirements of the effective shock wave energy size.

[0064] The following is Figures 1 to 14 The specific embodiment shown in the figure is used to illustrate that by changing the spatial position of the first electrode 10 and the second electrode 20, different discharge distances are formed between the first distal surface 11 and the second distal surface 21, so as to obtain shock waves with different single shock wave energy sizes. For example, at the location of the more severely hardened lesion tissue, a larger shock wave energy is implemented. The following structures are all applicable to the case where the distal surface of the shock wave electrode 100 is a plane or a convex surface, that is, they are all applicable to the case where the distribution form of the effective shock wave energy in space is a hemispherical form or a form larger than a hemisphere.

[0065] In the first type of embodiments, the second electrode 20 is spaced outside the first electrode 10, and the discharge gap formed between the outer contour of the first distal surface 11 and the inner contour of the second distal surface 21 is the discharge distance between the first distal surface 11 and the second distal surface 21. When a suitable voltage is applied to the first electrode 10 and the second electrode 20, a discharge breakdown occurs randomly between the entire outer contour of the first distal surface 11 and the inner contour of the second distal surface 21 to form a shock wave, and the discharge distance between the outer contour of the first distal surface 11 and the inner contour of the second distal surface 21 is at least one of equal and continuously increasing.

[0066] In the first case, the discharge distance between the inner contour of the second distal face 21 and the outer contour of the first distal face 11 is equal. The inner contour shape of the second distal face 21 is an equidistantly expanded shape of the outer contour shape of the first distal face 11. The equidistantly expanded shape refers to the inner contour of the second distal face 21, which is a shape formed by equidistantly expanding the outer contour of the first distal face 11. As a result, a discharge gap of uniform width is formed between the outer contour of the first distal face 11 and the inner contour of the second distal face 21. In the process of discharge breakdown between the first distal face 11 and the second distal face 21 to form a shock wave, the time interval of the shock wave remains almost unchanged, and the energy of a single shock wave is almost equal. In such a case, Figure 1 In the specific embodiment shown, the first distal surface 11 is circular (or annular), the second distal surface 21 is annular, and the second distal surface 21 is coaxially sleeved on the outer periphery of the first distal surface 11. The axis of the first electrode 10, the axis of the second electrode 20 and the axis of the shock wave electrode 100 overlap, so that the shock wave energy can form a uniform spatial distribution at the distal end of the shock wave electrode. The first distal surface 11 can also be elliptical or elliptical ring, and the second distal surface 21 is an elliptical ring that expands outward at equal distances from the first distal surface 11. In order to further increase the breakdown length of the first electrode 10 and the second electrode 20, the outer contour of the first distal surface 11 and the inner contour of the second distal surface 21 can also be wavy, and the discharge and breakdown can be formed along the outer contour of the entire wavy first distal surface 11 to form a shock wave.

[0067] In the second case, the discharge distance between the inner contour of the second distal end surface 21 and the outer contour of the first distal end surface 11 is continuously increased. In the process of the discharge breakdown between the first distal end surface 11 and the second distal end surface 21 to form a shock wave, the time interval of the shock wave gradually increases, and the energy of a single shock wave gradually increases. Figure 2 In the specific embodiment shown, the first distal face 11 is circular (it can also be annular, elliptical or elliptical ring), the second distal face 21 is elliptical ring (it can also be annular), and the axis of the second distal face 21 is spaced apart from the axis of the first distal face 11, that is, the second electrode 20 is non-concentrically arranged on the outer periphery of the first electrode 10.

[0068] In the third case, the discharge distance between the inner contour of the second distal end face 21 and the outer contour of the first distal end face 11 includes both an equal portion and a continuously increasing portion. In the process of the discharge breakdown between the first distal end face 11 and the second distal end face 21 to form a shock wave, in the portion where the discharge distance is equal, the time interval of the shock waves is almost unchanged and the energy of a single shock wave is almost equal, and in the portion where the discharge distance is continuously increasing, the time interval of the shock waves gradually increases and the energy of a single shock wave gradually increases. Figure 3 As shown, the first distal end face 11 includes two parallel sides, and the two parallel sides are respectively connected to two arcs, and the second distal end face 21 is an oval shape (the two parallel sides of the long rectangle are respectively connected to two semicircles). At the position of the two parallel sides of the first distal end face 11, the discharge distance between the inner contour of the second distal end face 21 and the outer contour of the first distal end face 11 is equal. At the arc position of the first distal end face 11, the discharge distance between the inner contour of the second distal end face 21 and the outer contour of the first distal end face 11 increases continuously.

[0069] In the second type of embodiments, the first electrode 10 and the second electrode 20 are arranged side by side with an interval, and a discharge gap formed between a portion of the first distal surface 11 adjacent to the second distal surface 21 and a portion of the second distal surface 21 adjacent to the first distal surface 11 is the discharge distance between the first distal surface 11 and the second distal surface 21. When a suitable voltage is applied to the first electrode 10 and the second electrode 20, discharge breakdown occurs randomly between adjacent portions of the first distal surface 11 and the second distal surface 21 to form a shock wave, and the discharge distance between the portion of the first distal surface 11 adjacent to the second distal surface 21 and the portion of the second distal surface 21 adjacent to the first distal surface 11 is at least one of equal and continuously increasing.

[0070] In the first case, the discharge distance between the portion of the first distal surface 11 adjacent to the second distal surface 21 and the portion of the second distal surface 21 adjacent to the first distal surface 11 are equal. Those skilled in the art should understand that the distance between the portion of the first distal surface 11 adjacent to the second distal surface 21 and the portion of the second distal surface 21 adjacent to the first distal surface 11 is the shortest spacing distance between the first distal surface 11 and the second distal surface 21. Figure 4 In the specific embodiment shown, the first distal end face 11 and the second distal end face 21 are both rectangular, and the rectangular long sides of the first distal end face 11 and the rectangular long sides of the second distal end face 21 are arranged parallel and spaced apart. In this embodiment, the distance between the rectangular long sides of the first distal end face 11 and the rectangular long sides of the second distal end face 21 is the same and is the shortest distance between the first distal end face 11 and the second distal end face 21. Figure 5 In the specific embodiment shown, the first distal face 11 and the second distal face 21 are both right-angled trapezoids, and the right-angled waist of the first distal face 11 and the right-angled waist of the second distal face 21 are arranged in parallel and spaced apart. In other words, regardless of whether the width of the first distal face 11 in the extension direction of the first distal face 11 is consistent, or whether the width of the second distal face 21 in the extension direction of the second distal face 21 is consistent, it is sufficient to ensure that there is at least one interval between the first distal face 11 and the second distal face 21, which is the same and is the shortest interval between the first distal face 11 and the second distal face 21. Those skilled in the art should understand that the first distal face 11 is a right-angled trapezoid and the second distal face 21 is a rectangle, or the first distal face 11 is a rectangle and the second distal face 21 is a right-angled trapezoid, which is also within the scope of protection of the present application. Figure 4 and Figure 5 In the specific embodiment shown, the two parallel sides between the first distal face 11 and the second distal face 21 are both straight lines. Those skilled in the art should understand that a curved side in the first distal face 11 and a curved side in the second distal face 21 being parallel are also within the protection scope of the present application.

[0071] In the second case, the discharge distance between the portion of the first distal end surface 11 adjacent to the second distal end surface 21 and the portion of the second distal end surface 21 adjacent to the first distal end surface 11 increases continuously. Figure 6 In a simple exemplary embodiment shown, the first distal end surface 11 and the second distal end surface 21 are both rectangular, the long sides of the two rectangular structures are arranged at intervals, and the interval distance between the two rectangular structures increases continuously.

[0072] In the third case, the discharge distance between the portion of the first distal end surface 11 adjacent to the second distal end surface 21 and the portion of the second distal end surface 21 adjacent to the first distal end surface 11 includes both an equal portion and a continuously increasing portion. Figure 7In the specific embodiments shown, the discharge distance between the first distal end face 11 and the second distal end face 21 first increases continuously and then remains equal.

[0073] The following takes Figure 8 the embodiments shown as an example to illustrate the influence of the change in the applied voltage on the single - shock wave energy. The discharge distances between the first distal end face 11 and the second distal end face 21 from small to large are L1, L2, L3, and L4 respectively, and the corresponding minimum breakdown voltages of L1, L2, L3, and L4 are U 01 , U 02 , U 03 and U 04 . The applied voltage is U0 and remains unchanged, and the discharge distance between the first distal end face 11 and the second distal end face 21 is L0. In the first stage, U 01 < U0 < U 02 , partial discharge breakdown occurs in the part where the condition L1 ≤ L0 < L2 is satisfied between the first distal end face 11 and the second distal end face 21. As the discharge breakdown continues, the discharge distance between the first distal end face 11 and the second distal end face 21 gradually increases, and the single - shock wave energy gradually increases, as shown in the E1 section of Fig. 9 . Since U0 < U 02 , the position where the discharge distance between the first distal end face 11 and the second distal end face 21 is L2 cannot have discharge breakdown. In the second stage, U0 is increased until U 02 < U0 < U 03 and then remains unchanged. Partial discharge breakdown occurs in the part where the condition L2 ≤ L0 < L3 is satisfied between the first distal end face 11 and the second distal end face 21. Similarly, as the discharge breakdown continues, the discharge distance between the first distal end face 11 and the second distal end face 21 gradually increases, and the single - shock wave energy gradually increases, as shown in the E2 section of Fig. 9 , until the discharge distance between the first distal end face 11 and the second distal end face 21 reaches L3 and the breakdown discharge terminates. Since U0 increases from the first stage to the second stage, there is an energy sudden increase from E1 to E2. In the third stage, U0 is increased until U0 ≥ U 04 , and in a sufficient duration, the first distal end face 11 and the second distal end face 21 complete all discharge breakdowns, and the change in the single - shock wave energy is as shown in the E3 section of Fig. 9 . Similarly, there is also an energy sudden increase from E2 to E3.

[0074] Furthermore, the first distal end face 11 and the second distal end face 21 can also adopt a multi - segment structure. By changing the connection mode of the wire with the first electrode 10 and the second electrode 20, the energy distribution of the shock wave in space can be changed.

[0075] In the third type of embodiments, the first distal end face 11 has a multi-segment structure, and the discharge distance between each segment of the first distal end face 11 and the second distal end face 21 is less than the sum of the discharge distance between this segment of the first distal end face 11 and another adjacent segment of the first distal end face 11 closest to it and the discharge distance between the other adjacent segment of the first distal end face 11 and the second distal end face 21. If the second electrode 20 is sleeved on the first electrode 10 at intervals, that is, multiple segments of the first distal end face 11 are arranged inside the second distal end face 21, the discharge distance between the outer contour of each segment of the first distal end face 11 and the inner contour of the second distal end face 21 is at least one of being equal, continuously increasing, and stepwise increasing. If the first electrode 10 and the second electrode 20 are arranged side by side at intervals, the discharge distance between the part of each segment of the first distal end face adjacent to the second distal end face and the part of the second distal end face adjacent to the first distal end face is at least one of being equal, continuously increasing, and stepwise increasing.

[0076] In a simple embodiment as shown in Fig.10 , the second distal end face 21 has a rectangular structure, and the first distal end face 11 includes a first distal end face first segment 1101, a first distal end face second segment 1102, and a first distal end face third segment 1103 that are sequentially arranged on one side of the second distal end face 21. The discharge distance between the first distal end face first segment 1101 and the second distal end face 21 is equal and is a1, and the minimum breakdown voltage of a1 is U1. The discharge distance between the first distal end face second segment 1102 and the second distal end face 21 is equal and is a2, and the minimum breakdown voltage of a2 is U2. The discharge distance between the first distal end face third segment 1103 and the second distal end face 21 is equal and is a3, and the minimum breakdown voltage of a3 is U3. Since a1 < a2 < a3, so U1 < U2 < U3.

[0077] When the three segments of the first distal end face 11 are connected to the same wire, the applied voltage is U'. By adjusting the magnitude of the applied voltage, different changes in shock wave energy can be obtained. If U1 < U' < U2, only the first distal end face first segment 1101 and the second distal end face 21 discharge and break down to form a shock wave, and the single-shot shock wave energy is basically stable. If U' > U3, in the first stage, the first distal end face first segment 1101 and the second distal end face 21 discharge and break down to form a shock wave, and the single-shot shock wave energy is basically stable until the first distal end face first segment 1101 is completely melted; in the second stage, the first distal end face second segment 1102 and the second distal end face 21 discharge and break down to form a shock wave, and the single-shot shock wave energy is basically stable until the first distal end face second segment 1102 is completely melted; in the third stage, the first distal end face third segment 1103 and the second distal end face 21 discharge and break down to form a shock wave, and the single-shot shock wave energy is basically stable; during the entire discharge process, the change in the single-shot shock wave energy is as shown in Fig.11As shown, it is first basically stable, then undergoes two sudden increases, and remains basically stable after the increase. Those skilled in the art should be able to understand the energy change of the shock wave obtained when U2 < U’ < U3, which will not be elaborated here.

[0078] When each of the three segments of the first distal end face 11 is connected to a wire, taking the second segment 1102 of the first distal end face as an example, the discharge interval between the second segment 1102 of the first distal end face and the first segment 1101 of the first distal end face is a201, and the discharge interval between the second segment 1102 of the first distal end face and the third segment 1103 of the first distal end face is a203. As Fig.10 shown, a201 > a203. When a2 < a3 + a203, a2 < a3 + a201 also holds. A voltage U” is applied between the second segment 1102 of the first distal end face and the second distal end face 21, where U” > U2. Since the closest discharge distance between the second segment 1102 of the first distal end face and the second distal end face 21 is a2, only a discharge breakdown occurs between the second segment 1102 of the first distal end face and the second distal end face 21 to form a shock wave, and the first segment 1101 and the third segment 1103 of the first distal end face have no influence on this discharge process. Those skilled in the art should be able to understand that if only a discharge breakdown between the first segment 1101 or the third segment 1103 of the first distal end face and the second distal end face 21 is required to form a shock wave, it can be achieved by adjusting the magnitude of U”. Thus, the energy magnitude of the shock wave can be selected according to the degree of hardening of the hardened tissue at the lesion site.

[0079] In the fourth type of embodiment, the second distal end face 21 is a multi-segment structure, and the discharge distance between each segment of the second distal end face 21 and the first distal end face 11 is less than the sum of the discharge distance between this segment of the second distal end face 21 and its nearest adjacent other segment of the second distal end face 21 and the discharge distance between the nearest adjacent other segment of the second distal end face 21 and the first distal end face 11. If the second electrode 20 is sleeved outside the first electrode 10 at intervals, the discharge distance between the inner contour of each segment of the second distal end face 21 and the outer contour of the first distal end face 11 is at least one of equal, continuously increasing, and stepwise increasing. If the first electrode 10 and the second electrode 20 are arranged side by side at intervals, the discharge distance between the part of each segment of the second distal end face 21 adjacent to the first distal end face 11 and the part of the first distal end face 11 adjacent to the second distal end face 21 is at least one of equal, continuously increasing, and stepwise increasing. Preferably, the segments of the second distal end face 21 are arranged at uniform intervals.

[0080] As Fig.12In a preferred embodiment shown, the first distal end face 11 is annular, and the second distal end face 21 includes a first sub-electrode segment 211, a second sub-electrode segment 212, and a third sub-electrode segment 213, all of which are arc-shaped structures and have equal diameters, and these three arc-shaped structures are evenly spaced and concentrically sleeved on the circular periphery of the first distal end face 11. When the three segments of the second distal end face 21 are each connected to a wire, the occurrence area and the number of occurrences of shock waves with equal single shock wave energy can be selected. For example, when the applied voltage is U'' and the number of shock wave induction times required is N, the number of times the shock wave occurs between the first sub-electrode segment 211 and the first distal surface 11, the number of times the shock wave occurs between the second sub-electrode segment 212 and the first distal surface 11, and the number of times the shock wave occurs between the third sub-electrode segment 213 and the first distal surface 11 are all controlled to be N / 3, so as to obtain a relatively uniform spatial distribution of shock wave energy. Alternatively, the shock wave occurrence area is selected according to the location of the hardened tissue at the lesion site, without adjusting the shock wave balloon catheter using this electrode structure. When the three segments of the second distal surface 21 are connected to the same wire, the shock wave occurs randomly between each segment of the second distal surface 21 and the first distal surface 11. In actual experiments, it is found that compared with Figure 1 In the illustrated embodiment, the shock wave occurs randomly between the outer circumference of the first distal surface 11 and the inner circumference of the second distal surface 21. The second distal surface 21 is configured as a three-section arc structure with uniform intervals, and the distribution of the shock wave energy in space is also more uniform.

[0081] like Fig.13 In another preferred embodiment shown, the first distal surface 11 is circular, and the second distal surface 21 includes a second distal surface first section 2101, a second distal surface second section 2102, a second distal surface third section 2103, and a second distal surface fourth section 2104, all of which are arc-shaped structures with successively increasing diameters. The central angles of these four arc structures are the same, and the angles between the central angles of two adjacent arc structures are the same. At the same time, these four arc structures are concentrically sleeved on the circular periphery of the first distal surface 11. Fig.12 The same as the embodiments shown is that when the four sections of the second distal surface 21 are each connected to a wire, the location and number of occurrences of the shock wave can be selected, and the difference is that the discharge distance between each arc structure and the first distal surface 11 is different, and the single shock wave energy of the shock wave induced is also different. By rotating the shock wave balloon catheter with this electrode structure, a shock wave with greater energy can be released to the location where the sclerosis tissue of the lesion is more severe.

[0082] In the fifth type of embodiments, the first distal surface 11 and the second distal surface 21 are both multi-segment structures; if the second electrode 20 is arranged outside the first electrode 10 at intervals, the discharge distance between the outer contour of each segment of the first distal surface and the inner contour of at least one segment of the second distal surface is equal, continuously increasing, and step-increasing; if the first electrode 10 and the second electrode 20 are arranged side by side at intervals, the discharge distance between the portion adjacent to each segment of the first distal surface 11 and the second distal surface 21 and the portion adjacent to the second distal surface 21 is equal, continuously increasing, and step-increasing.

[0083] like Fig.14 In a specific embodiment shown, the first distal end face 11 and the second distal end face 21 are both four-segment rectangular structures, and the four-segment rectangular structures of the second distal end face 21 correspond to the four-segment rectangular structures of the first distal end face 11 to form four groups of electrode pairs, and the distance between the two rectangular structures in each group of electrode pairs is equal. By selecting the electrode pair for discharge breakdown to form the shock wave, the initiation position and initiation number of the shock wave can be controlled.

[0084] The embodiment of the present invention further provides a shock wave balloon catheter 200, comprising the shock wave electrode 100 as described above, a tube body 80 and an expansion element 30 capable of being filled with a conductive liquid, the expansion element 30 being sealed and connected to the distal end of the tube body 80, the first distal end face 11 and the second distal end face 21 of the shock wave electrode 100 being both located in the expansion element 30; when the expansion element 30 is filled with a conductive liquid and a voltage is applied to the first electrode 10 and the second electrode 20 of the shock wave electrode, shock waves can be induced only between the first distal end face 11 and the second distal end face 21. The tube body 80 includes a catheter body that enters the human body and other external parts, and the other external parts include, for example, a handle, a side branch, and other circuit interfaces and fluid circuit interfaces.

[0085] It can be seen from the description of the prior art that in the process of forming a shock wave using the liquid-electric method, small bubbles will be formed on the discharge surface of the first electrode 10 and the second electrode 20, and large bubbles will also be formed in the conductive liquid. The small bubbles accumulated on the discharge surface will affect the conductive properties of the conductive liquid, and then affect the discharge breakdown between the first distal end face 11 and the second distal end face 21. The large bubbles in the conductive liquid will affect the intensity of the shock wave (the size of the shock wave energy) during the shock wave transmission process. For this reason, the shock wave balloon catheter 200 of the present application is further provided with a circulation system of the conductive liquid, so that the conductive liquid can flow during the discharge breakdown process, so that the large bubbles and small bubbles are taken away by the flowing conductive liquid.

[0086] The shock wave electrode 100 of the present application may further include a through cavity, which is used as a guide wire cavity or a fluid inlet cavity 50 for a conductive liquid. When the through cavity of the shock wave electrode 100 is used as a fluid inlet cavity 50 for a conductive liquid, the tube body 80 may be provided with a fluid discharge cavity 60, and the outflow port of the fluid inlet cavity 50 and the inflow port of the fluid discharge cavity 60 are both located in the expansion element 30, so as to form a circulation system for the conductive liquid, and the conductive liquid enters from the fluid inlet cavity 50 and flows through the discharge surface between the first distal end face 11 and the second distal end face 21, and then flows out through the fluid discharge cavity 60, taking away large bubbles in the conductive liquid and small bubbles formed on the discharge surfaces of the first electrode 10 and the second electrode 20, and flushing the first distal end face 11 and the second distal end face 21. Alternatively, the shock wave electrode 100 further includes a through first fluid inlet cavity and a through first fluid discharge cavity; the distance between the first fluid inlet cavity and the axis of the shock wave electrode 100 is smaller than the distance between the first fluid discharge cavity and the axis of the shock wave electrode 100, the conductive liquid enters from the first fluid inlet cavity, flows out through the first fluid discharge cavity, takes away the large bubbles in the conductive liquid, the small bubbles formed on the discharge surfaces of the first electrode 10 and the second electrode 20, and washes the first distal end face 11 and the second distal end face 21. When the shock wave electrode 100 has the first fluid inlet cavity and the first fluid discharge cavity, the outflow port of the first fluid inlet cavity and the inlet port of the first fluid discharge cavity are both located in the expansion element 30. Whether the fluid inlet cavity 50, the first fluid inlet cavity or the first fluid discharge cavity should not be arranged in the discharge gap between the first distal end face 11 and the second distal end face 21, so as to avoid affecting the insulation environment between the first distal end face 11 and the second distal end face 21. Alternatively, the through cavity of the shock wave electrode 100 of the present application is used as a guide wire cavity, and when the tube body 80 has a second fluid inlet cavity and a second fluid discharge cavity, the outflow port of the second fluid inlet cavity and the inflow port of the second fluid discharge cavity are located in the expansion element 30, and the conductive liquid enters from the second fluid inlet cavity and flows out through the second fluid discharge cavity, taking away large bubbles in the conductive liquid and small bubbles formed on the discharge surfaces of the first electrode 10 and the second electrode 20.

[0087] by Fig. 27Taking the shock wave electrode 100 as an example, the second electrode 20 is coaxially sleeved outside the first electrode 10, the first distal end face 11 is annular, the second distal end face 21 is three equal-diameter arcs arranged at equal intervals and coaxially, and the first electrode 10 has a central through cavity; an insulating portion 40 is arranged between the first electrode 10 and the second electrode 20; the first distal end face 11, the distal end face 41 of the insulating portion 40 and the second distal end face 21 are located on the same smooth convex surface, which is the distal end face of the shock wave electrode. Relative to the second distal end face 21, the first distal end face 11 is closer to the distal end. An insulating member 70 made of an insulating material is filled between the three equal-diameter arcs of the second distal end face 21. The insulating material can be a polymer insulating material used in the prior art, or it can be an insulating material that is the same as the material of the insulating portion 40.

[0088] In one embodiment, the central through cavity of the first electrode 10 is used as the fluid inlet cavity 50. Fig.28 As shown, the expansion element 30 of the shock wave balloon catheter 200 is a blind-end balloon, and the tube body 80 is provided with a fluid discharge cavity 60. The blind-end balloon refers to a balloon with a closed end at the distal end. In the process of forming the shock wave, the conductive liquid continuously enters the blind-end balloon from the fluid inlet cavity 50 and flows out from the fluid discharge cavity 60, which can not only take away the large bubbles in the conductive liquid and the small bubbles formed on the discharge surfaces of the first electrode 10 and the second electrode 20, but also can wash the first distal end surface 11 and the second distal end surface 21, and under the action of the reverse shock wave, take away the metal melt on the first distal end surface 11 and the second distal end surface 21. When in use, the shock wave balloon catheter 200 is first placed near the tissue to be treated in the human body, and a conductive liquid is injected and pressurized through the fluid inlet cavity 50, so that the blind-end balloon is close to or against the tissue to be treated; the first distal surface 11 and the second distal surface 21 are discharged and broken down to form a shock wave, and the target shock wave energy value is obtained. At a set frequency, the shock wave is released after a set time to obtain the cumulative shock wave energy required for treatment until the treatment is completed; in the process of releasing the shock wave, the conductive liquid is made to flow to take away the bubbles and the smaller electrode melt in the blind-end balloon. The conductive liquid can flow continuously or flow in the gaps between the shock waves to complete the replacement of the conductive liquid.

[0089] Still taking the shock wave electrode 100 of this structure as an example, the central through cavity of the first electrode 10 is the guide wire cavity 90. The expansion element 30 of the shock wave balloon catheter 200 is a balloon with a central cavity, and the tube body 80 has not only a second fluid inlet cavity and a second fluid discharge cavity, but also a cavity for passing a guide wire, and the central cavity is connected with the guide wire cavity of the first electrode 10. The guide wire can enter the guide wire cavity of the first electrode 10 and the central cavity of the expansion element in sequence through the cavity of the tube body 80, and extend from the distal end of the central cavity of the expansion element, and the shock wave balloon catheter 200 can be quickly and accurately delivered to the lesion site by relying on the guide wire.

[0090] As can be seen from the above, the shock wave electrode 100 and the shock wave balloon catheter 200 of the present application have a larger electrode effective melting volume, can withstand a sufficiently high applied voltage for a sufficient number of times, and under a suitable applied voltage and electrode distance, have more shock wave initiation times and a larger cumulative shock wave energy, and can continuously perform shock wave treatment on the tissue to be treated in the part that cannot or is inconvenient to expand, so that the hardened tissue in the part that cannot or is inconvenient to expand can be treated by using only shock wave energy.

[0091] The above is only a specific implementation of the present application, but the protection scope of the present application is not limited thereto. Any changes or substitutions that can be easily thought of by a person skilled in the art within the technical scope disclosed in the present application should be included in the protection scope of the present application. Therefore, the protection scope of the present application shall be based on the protection scope of the claims.

Claims

1. A shock wave electrode, characterized in that: include: A first electrode and a second electrode which are spaced apart and extend in the same direction; The first electrode has a first distal surface, and the second electrode has a second distal surface; when the first distal surface and the second distal surface are located in a conductive liquid and a voltage is applied to the first electrode and the second electrode, a shock wave can be induced only between the first distal surface and the second distal surface; The first distal end surface is a multi-segment structure, and the discharge distance between each segment of the first distal end surface and the second distal end surface is smaller than the sum of the discharge distance between the segment of the first distal end surface and another segment of the first distal end surface that is closest to it and the discharge distance between the another segment of the first distal end surface that is closest to it and the second distal end surface; The second electrode is sleeved outside the first electrode at intervals, and the first distal end surface and the second distal end surface are located in the same cross section, or the first distal end surface is located at the distal end of the second distal end surface; the discharge distance between the outer contour of each section of the first distal end surface and the inner contour of the second distal end surface is at least one of equal, continuously increasing, and step-increasing; or, The first electrode and the second electrode are arranged side by side with an interval, and the first distal surface and the second distal surface are located in the same cross section; or, the distance between the first distal surface and the axis of the tube body is smaller than the distance between the second distal surface and the axis of the tube body, and the first distal surface is located at the distal end of the second distal surface; the discharge distance between each section of the first distal surface adjacent to the second distal surface and the section of the second distal surface adjacent to the first distal surface is at least one of equal, continuously increasing and step-increasing; the first distal surface is a rectangle or a right-angled trapezoid, the second distal surface is a rectangle or a right-angled trapezoid, the long side or right-angled side of the first distal surface is parallel to the long side or right-angled side of the second distal surface, the interval distance increases gradually or the interval distance increases in a step-like manner.

2. The shock wave electrode according to any one of claims 1, characterized in that The segments of the first distal end surface are evenly spaced; or, The first distal end surface is a plane or a curved surface, and the second distal end surface is a plane or a curved surface; or, The distal end surface of the shock wave electrode is a plane or a convex surface, and the first distal end surface and the second distal end surface are located on the plane or the convex surface; or, When the area of ​​the first distal end surface is smaller than the area of ​​the second distal end surface, the first electrode is a positive electrode; when the area of ​​the second distal end surface is smaller than the area of ​​the first distal end surface, the second electrode is a positive electrode; or, The material of the first electrode and the material of the second electrode include stainless steel, tungsten, tungsten alloy, titanium, titanium alloy, platinum, platinum alloy; or, It also includes an insulating portion, which is disposed between the first electrode and the second electrode; or, Also includes a through cavity; or, It also includes a through first fluid inlet cavity and a through first fluid discharge cavity; the distance between the first fluid inlet cavity and the axis of the shock wave electrode is smaller than the distance between the first fluid discharge cavity and the axis of the shock wave electrode.

3. The shock wave electrode according to claim 2, characterized in that: When the shock wave electrode further comprises an insulating portion, and the insulating portion is disposed between the first electrode and the second electrode, The insulating portion is filled and arranged between the first electrode and the second electrode. or, Insulation materials include ceramic, mineral, bakelite, modified impact-resistant glass or quartz.

4. A shock wave electrode, characterized in that: include: A first electrode and a second electrode which are spaced apart and extend in the same direction; The first electrode has a first distal surface, and the second electrode has a second distal surface; when the first distal surface and the second distal surface are located in a conductive liquid and a voltage is applied to the first electrode and the second electrode, a shock wave can be induced only between the first distal surface and the second distal surface, and both the first distal surface and the second distal surface are multi-segment structures.

5. The shock wave electrode according to claim 4, characterized in that: The second electrode is sleeved outside the first electrode at intervals, and the discharge distance between the outer contour of each first distal end surface and the inner contour of at least one second distal end surface is equal, continuously increased, or stepped.

6. The shock wave electrode according to claim 5, characterized in that: The axis of the second distal end surface is spaced apart from the axis of the first distal end surface. The first distal end surface is in the shape of multiple arcs or multiple elliptical arcs, and the second distal end surface is in the shape of multiple arcs or multiple elliptical arcs.

7. The shock wave electrode according to claim 4, characterized in that: The first electrode and the second electrode are arranged side by side with an interval, and the discharge distance between each section of the first distal end surface adjacent to the second distal end surface and at least one of the sections of the second distal end surface adjacent to the first distal end surface is equal, continuously increased, and stepped increased.

8. The shock wave electrode according to claim 7, characterized in that: The first distal end face is a rectangle or a right-angled trapezoid, the second distal end face is a rectangle or a right-angled trapezoid, the long side or right-angled side of the first distal end face is parallel to the long side or right-angled side of the second distal end face, and the spacing distance gradually increases or the spacing distance increases in steps.

9. The shock wave electrode according to any one of claims 4 to 8, characterized in that: The segments of the first distal end surface are evenly spaced, and the segments of the second distal end surface are evenly spaced; or, The first distal end surface is a plane or a curved surface, and the second distal end surface is a plane or a curved surface; or, The distal end surface of the shock wave electrode is a plane or a convex surface, and the first distal end surface and the second distal end surface are located on the plane or the convex surface; or, When the area of ​​the first distal end surface is smaller than the area of ​​the second distal end surface, the first electrode is a positive electrode; when the area of ​​the second distal end surface is smaller than the area of ​​the first distal end surface, the second electrode is a positive electrode; or, The material of the first electrode and the material of the second electrode include stainless steel, tungsten, tungsten alloy, titanium, titanium alloy, platinum, platinum alloy; or, It also includes an insulating portion, which is disposed between the first electrode and the second electrode; or, Also includes a through cavity; or, It also includes a through first fluid inlet cavity and a through first fluid discharge cavity; the distance between the first fluid inlet cavity and the axis of the shock wave electrode is smaller than the distance between the first fluid discharge cavity and the axis of the shock wave electrode.

10. The shock wave electrode according to claim 9, characterized in that: When the shock wave electrode further includes an insulating portion, and the insulating portion is disposed between the first electrode and the second electrode, the insulating portion is filled and disposed between the first electrode and the second electrode. or, Insulation materials include ceramic, mineral, bakelite, modified impact-resistant glass or quartz.

11. A shock wave balloon catheter, characterized in that: include: A shock wave electrode, a tube body and an expansion element capable of being filled with a conductive liquid as described in any one of claims 1 to 10; the expansion element is sealed and connected to the distal end of the tube body, and the first distal end face and the second distal end face of the shock wave electrode are both located in the expansion element; when the expansion element is filled with a conductive liquid and a voltage is applied to the first electrode and the second electrode of the shock wave electrode, a shock wave can be induced only between the first distal end face and the second distal end face.

12. The shock wave balloon catheter according to claim 11, characterized in that: When the shock wave electrode has a through cavity, the tube body is provided with a fluid discharge cavity, and the flow outlet of the through cavity and the flow inlet of the fluid discharge cavity are both located in the expansion element; or, When the shock wave electrode has a first fluid inlet cavity and a first fluid discharge cavity, the outflow port of the first fluid inlet cavity and the inlet port of the first fluid discharge cavity are located in the expansion element; or, The tube body has a second fluid inlet cavity and a second fluid discharge cavity, and an outflow port of the second fluid inlet cavity and an inlet port of the second fluid discharge cavity are located in the expansion element.

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