Electrode assembly and shock wave balloon thereof

Abstract

The electrode assembly comprises at least two annular electrodes, a gap is formed between every two adjacent annular electrodes, and the annular electrodes are respectively connected with a power source. The annular electrode is configured to be capable of generating arc discharge in the gap and forming shock waves when voltage is applied, and the shock waves can be propagated in a medium around the slender component; the gap is configured to receive a conductive medium to facilitate formation of an arc discharge. The shock wave balloon aims at solving the problems that the discharge frequency of shock waves of the shock wave balloon is small, and the positioning direction of the shock waves is poor.

Description

Technical Field

[0001] This utility model relates to the field of interventional medical device technology, and in particular to an electrode assembly and its shockwave balloon. Background Technology

[0002] With the fast pace of life and unhealthy lifestyles, the incidence of vascular diseases is increasing year by year. Among them, vascular calcification is a common vascular pathological manifestation that has attracted widespread attention. In recent years, an emerging technology for treating vascular calcification—intraperitoneal shock wave lithotripsy—has begun to show promise in clinical applications abroad. The basic principle of this technology is to apply a high-voltage pulse to electrodes in a conductive liquid, generating a breakdown discharge. Under the influence of the electric field, the liquid cavitates, forming bubbles that burst instantaneously, thereby generating shock waves that break up the calcified lesions. In use, the shock wave balloon is first advanced to the calcified area in the blood vessel and then low-pressure inflated to conform to the vessel wall. Then, the high-voltage pulse power supply is activated to generate intermittent shock waves, thereby breaking up superficial and deep calcified plaques within the blood vessel. Finally, the balloon is further inflated to fully expand the blood vessel lumen, achieving the therapeutic goal. Summary of the Invention

[0003] Multiple experiments have revealed that the electrodes of shockwave balloons are usually made of metal materials. Shock waves are generated through the electrodes, and the electrodes are consumed after generating shock waves, especially after generating shock waves multiple times. Furthermore, the discharge point of the shock wave often occurs on the path of least impedance between the electrodes.

[0004] The purpose of this invention is also to provide an electrode assembly and a shock wave balloon to solve the problems of low discharge frequency and / or shock wave positioning direction and / or improve wiring efficiency and / or improve the passability of the shock wave balloon.

[0005] To achieve the above objectives, the first aspect of the present invention provides an electrode assembly for being disposed on the outer periphery of an elongated member. The electrode assembly includes at least two annular electrodes, with a gap between adjacent annular electrodes, and the annular electrodes are respectively connected to a power source.

[0006] The annular electrode is configured to generate an arc discharge and form a shock wave in the gap when a voltage is applied, and the shock wave can propagate in the medium around the slender member; the gap is configured to contain a conductive medium to facilitate the formation of the arc discharge.

[0007] As a preferred technical solution, at least one end of at least one annular electrode is a complete circle.

[0008] As a preferred technical solution, at least one ring electrode is configured as a closed ring structure or an open ring structure.

[0009] As a preferred technical solution, the distance between adjacent annular electrodes is 0.1-5 mm.

[0010] As a preferred technical solution, at least one annular electrode is provided with at least one protrusion, the protrusion is disposed in the gap between adjacent annular electrodes, and the distance between the protrusion and the adjacent annular electrode is smaller than the distance between other areas between adjacent annular electrodes.

[0011] As a preferred technical solution, it also includes an electrode bridge, which is disposed between two adjacent annular electrodes;

[0012] The electrode bridge comprises at least a portion of conductive material, and there are gaps between the electrode bridge and the adjacent annular electrode.

[0013] As a preferred technical solution, the electrode bridge is not connected to a power source.

[0014] As a preferred technical solution, at least one protrusion is provided at both ends of the electrode bridge.

[0015] As a preferred technical solution, the two ends of the annular electrode adjacent to the electrode bridge are smooth.

[0016] A second aspect of the present invention provides an electrode assembly disposed on the outer periphery of an elongated member. The electrode assembly includes at least two axially arranged annular electrodes, wherein the annular electrodes are closed annular structures or open annular structures, and a gap is provided between two adjacent annular electrodes; at least one end of at least one annular electrode is a complete circumference.

[0017] At least one electrode bridge is provided between adjacent annular electrodes, and at least a portion of the electrode bridge is made of conductive material. The electrode bridge has a gap with each adjacent annular electrode.

[0018] As a preferred technical solution, at least one annular electrode is provided with at least one protrusion, the protrusion is disposed at the gap of the annular electrode, and the gap distance between the protrusion and the adjacent annular electrode is smaller than the other gap distances between the adjacent annular electrodes.

[0019] As a preferred technical solution, the annular electrode includes a first annular electrode and a second annular electrode, with a gap between the first annular electrode and the second annular electrode;

[0020] At least the first annular electrode has at least one protrusion, and the protrusion is disposed on the side adjacent to the second annular electrode; or, at least the second annular electrode has at least one protrusion, and the protrusion is disposed on the side adjacent to the first annular electrode.

[0021] As a preferred technical solution, the first annular electrode has several protrusions circumferentially, and adjacent protrusions are arranged at equal or unequal intervals; or, the second annular electrode has several protrusions circumferentially, and adjacent protrusions are arranged at equal or unequal intervals.

[0022] As a preferred technical solution, both the first annular electrode and the second annular electrode are provided with protrusions. The circumferentially adjacent protrusions are arranged at equal and / or unequal intervals, and the axially adjacent protrusions are arranged opposite to each other and / or staggered.

[0023] As a preferred technical solution, at least one end of at least one electrode bridge is a smooth circle;

[0024] Or at least one end of at least one electrode bridge is provided with a protrusion;

[0025] Alternatively, at least one end of the electrode bridge may have at least one protrusion, and at least one end of the adjacent annular electrode may be smooth.

[0026] As a preferred technical solution, the electrode bridge includes a first electrode bridge, which has a plurality of protrusions. The protrusions are disposed on the side of the first electrode bridge opposite to the first annular electrode, and / or the protrusions are disposed on the side of the first electrode bridge opposite to the second annular electrode.

[0027] As a preferred technical solution, the circumferentially adjacent protrusions are arranged at equal and / or unequal intervals;

[0028] When both sides of the first electrode bridge are provided with protrusions, the axially adjacent protrusions are staggered and / or axially corresponding.

[0029] As a preferred technical solution, each end of the electrode bridge is provided with at least one protrusion, and the ends of adjacent annular electrodes are smooth.

[0030] As a preferred technical solution, the annular electrode is a flexible electrode.

[0031] As a preferred technical solution, the electrode bridge includes a first electrode bridge and a second electrode bridge, the second electrode bridge is arranged adjacent to the first electrode bridge, and gaps are provided between the second electrode bridge and the first electrode bridge and between the second annular electrode.

[0032] A third aspect of this invention provides a shockwave balloon, including an elongated member for entering a human body lumen, the distal end of the elongated member being the end that enters the human body, and the distal end of the elongated member being provided with an electrode assembly as described in any of the above claims.

[0033] The fourth aspect of this invention provides the application of the above-mentioned shock wave generating device and / or shock wave balloon in the treatment of vascular calcification and / or human lumen stones.

[0034] The aforementioned vascular calcifications include one or more of the following: peripheral vascular calcification, coronary artery calcification, carotid artery calcification, intracranial artery calcification, aortic arch calcification, and valve calcification.

[0035] The fifth aspect of this invention provides the application of the above-mentioned shock wave generating device and / or shock wave balloon in the treatment of poor stent apposition.

[0036] The aforementioned stents include one or more of the following: digestive tract stents, vascular stents, urinary system stents, ENT stents, reproductive system stents, and respiratory system stents.

[0037] During the procedure, interventional radiologists may discover poor apposition of the endovascular stent by using imaging techniques such as angiography, OCT, and IVUS. They can then use the shock wave generator or shock wave balloon described in this invention to emit shock waves, thereby promoting stent apposition to the vessel wall and facilitating the endothelialization process.

[0038] The aforementioned shock wave generating device and / or shock wave balloon can be applied to stents in the digestive tract, urinary system, ENT, reproductive system, and respiratory system where apposition to the stent is poor.

[0039] The purpose of this invention is also to provide an electrode assembly and a shock wave balloon to solve the problems of low discharge frequency and / or shock wave positioning direction and / or improve wiring efficiency and / or improve the passability of the shock wave balloon.

[0040] To achieve the above objectives, another aspect of this utility model provides an electrode assembly disposed on the outer periphery of an elongated member. The electrode assembly includes at least two axially arranged annular electrodes, wherein the annular electrodes are closed or open ring structures, and a gap is provided between two adjacent annular electrodes; at least one end of at least one annular electrode is a complete circumference; at least one electrode bridge is provided between adjacent annular electrodes, at least a portion of the electrode bridge is made of conductive material, and a gap is provided between the electrode bridge and each adjacent annular electrode; the electrode bridge is not connected to a wire.

[0041] As a preferred technical solution, the electrode bridge has a protrusion at each end. More preferably, the two protrusions are 180° opposite each other.

[0042] As a preferred technical solution, the ends of the first and second annular electrodes adjacent to the electrode bridge are smooth circumferences.

[0043] The purpose of this invention is also to provide an electrode assembly and a shock wave balloon to solve the problems of low discharge frequency and / or shock wave positioning direction and / or improve wiring efficiency and / or improve the passability of the shock wave balloon.

[0044] To achieve the above objectives, another aspect of this utility model provides an electrode assembly disposed on the outer periphery of an elongated member. The electrode assembly includes at least two axially arranged annular electrodes, wherein the annular electrodes are closed or open ring structures, and a gap is provided between two adjacent annular electrodes; at least one end of at least one annular electrode is a complete circumference; at least one electrode bridge is provided between adjacent annular electrodes, at least a portion of the electrode bridge is made of conductive material, and a gap is provided between the electrode bridge and each adjacent annular electrode; each end of the electrode bridge has a protrusion.

[0045] As a preferred technical solution, the two protrusions are 180° opposite each other.

[0046] As a preferred technical solution, the electrode bridge is not connected to wires.

[0047] As a preferred technical solution, the ends of the first and second annular electrodes adjacent to the electrode bridge are smooth circumferences.

[0048] The electrode assembly provided in this embodiment can be applied to shock wave balloons. The electrode assembly consists of multiple annular electrodes disposed on the outer periphery of an elongated member and bonded together with an adhesive. At least one protrusion is provided at the gap between the annular electrodes and / or electrode bridges. The gap between the protrusion and adjacent annular electrodes is smaller than the gaps at other locations between the annular electrodes. That is, the gap between the protrusion and adjacent annular electrodes is minimal, smaller than the normal gap between two annular electrodes. Because the gap between the protrusion and the annular electrode is smaller than the gap between the annular electrodes, the shock wave is generated at the protrusion. Each shock wave causes some wear on the electrode, making the gap at the protrusion slightly larger. Therefore, each time a shock wave is generated at one protrusion, the next time it is generated at another protrusion. This allows the location of the shock wave to be cyclical, ensuring that the location of the shock wave is controllable and that the damage to the protrusion is evenly distributed. This allows the electrode assembly to generate multiple shock waves in a single surgery, ensuring the stability and durability of the electrode assembly and making the shock wave balloon safer.

[0049] Meanwhile, the protrusion, as the point where the shock wave is generated, prevents the occurrence of shock wave phenomena between the wire and the ring electrode solder joint, making the wire connection more stable.

[0050] The protrusions provided at the gaps between the annular electrodes and / or electrode bridges can guide the direction of the shock wave, so that the propagation of the shock wave within the balloon is evenly distributed in two or more directions.

[0051] The above and other objects, advantages and features of this utility model will become more apparent to those skilled in the art from the following detailed description of specific embodiments of this utility model in conjunction with the accompanying drawings. Attached Figure Description

[0052] To more clearly illustrate the technical solutions of the embodiments of this utility model, the accompanying drawings used in the description of the embodiments will be briefly introduced below, forming part of this utility model. The illustrative embodiments of this utility model and their descriptions explain this utility model and do not constitute an improper limitation of this utility model. In the accompanying drawings:

[0053] Figure 1 This is a schematic diagram of a shockwave balloon in an embodiment of this utility model;

[0054] Figure 2 This is a schematic diagram of an electrode assembly in a shock wave balloon according to an embodiment of the present invention;

[0055] Figure 3 This is a schematic diagram of an electrode assembly in a shock wave balloon according to an embodiment of the present invention;

[0056] Figure 4 This is a schematic diagram of an electrode assembly in a shock wave balloon according to an embodiment of the present invention;

[0057] Figure 5 This is a schematic diagram of the electrode assembly in an embodiment of the present invention;

[0058] Figure 6 This is a schematic diagram of the electrode assembly in an embodiment of the present invention;

[0059] Figure 7 This is a schematic diagram of a preferred electrode assembly in an embodiment of the present invention;

[0060] Figure 8 This is a schematic diagram of the electrode assembly in an embodiment of the present invention;

[0061] Figure 9 This is a schematic diagram of the electrode assembly in an embodiment of the present invention;

[0062] Figure 10 This is a schematic diagram of the electrode assembly in an embodiment of the present invention;

[0063] Figure 11 This is a schematic diagram of the electrode assembly in an embodiment of the present invention;

[0064] Figure 12 This is a schematic diagram of the electrode assembly in an embodiment of the present invention;

[0065] Figure 13 This is a schematic diagram of the electrode assembly in an embodiment of the present invention;

[0066] Figure 14 This is a schematic diagram of the protrusion in an embodiment of the present invention.

[0067] Explanation of reference numerals in the attached figures:

[0068] The conduit 10, proximal end 11, imaging ring 12, positive electrode wire 13, negative electrode wire 14, distal end 20, electrode assembly 30, protrusion 301, conductive material 302, non-conductive material 303, first annular electrode 31, second annular electrode 32, first electrode bridge 33, and second electrode bridge 34. Detailed Implementation

[0069] To make the objectives, technical solutions, and advantages of this utility model clearer, the technical solutions of this utility model will be clearly and completely described below in conjunction with specific embodiments and corresponding drawings. In the description of this utility model, it should be noted that the term "or" is generally used to include the meaning of "and / or," unless otherwise expressly stated otherwise.

[0070] In the description of this utility model, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "joining" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances. Furthermore, in the description of this application, the terms "first," "second," etc., are used only for distinguishing descriptions and should not be construed as indicating or implying relative importance.

[0071] In the field of interventional medical device technology, the direction closer to the operator is generally defined as proximal, and the direction farther from the operator is defined as distal. The direction of the central axis of objects such as cylinders and tubes is defined as axial. Radial refers to the direction passing through the central axis in the radial plane, for example, a straight line along a diameter or radius, or a straight line perpendicular to the central axis.

[0072] Obviously, the described embodiments are only some embodiments of this utility model, and not all embodiments. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the protection scope of this utility model.

[0073] To address the problems existing in the prior art, embodiments of the present invention provide an electrode assembly disposed on the outer periphery of an elongated member for generating shock waves. The elongated member is preferably configured as a conduit 10, such as... Figure 1 , Figure 8 The catheter 10 is delivered into the human body through blood vessels. During surgery, the proximal end 11 of the catheter 10 is outside the body. It is preferably equipped with a handle and connected to a power source. The surgeon controls the catheter 10 through the handle so that its distal end 20 enters the human body.

[0074] Preferably, the electrode assembly 30 includes at least two annular electrodes, which are defined as a first annular electrode 31 and a second annular electrode 32, respectively. A gap is provided between the first annular electrode 31 and the second annular electrode 32. Figure 8 The first annular electrode 31 and the second annular electrode 32 are respectively connected to the power supply, and there is a gap between them. When the annular electrode is subjected to voltage, an arc discharge can be generated in the adjacent gap and a shock wave can be formed. The shock wave can propagate in the medium around the catheter 10. The gap between the first annular electrode 31 and the second annular electrode 32 contains a conductive medium, such as physiological saline, to promote the formation of arc discharge.

[0075] Preferably, the spacing between the first annular electrode 31 and the second annular electrode 32 is configured to be 0.1~5mm.

[0076] In a preferred embodiment, at least one end of at least one annular electrode is a complete circle; preferably, the circumferential surface is perpendicular to the axis of the annular electrode, and the other end may be configured as a circumferential surface having an angle that is not a right angle with the axis of the annular electrode. In this case, the other end of the annular electrode is an inclined surface, or both ends of the annular electrode are configured as a complete circle.

[0077] In another preferred embodiment, at least one annular electrode is configured as a closed annular structure or an open annular structure. When the annular electrode is configured as an open annular structure, the opening positions of adjacent annular electrodes can be set correspondingly or staggered, without specific limitations.

[0078] refer to Figure 1 and Figure 9 In a preferred embodiment, the first annular electrode 31 has at least one protrusion 301 on the side adjacent to the second annular electrode 32, or the second annular electrode 32 has at least one protrusion 301 on the side adjacent to the first annular electrode 31. The distance between the protrusion 301 and the adjacent annular electrode is less than the distance between other areas of the two annular electrodes. In this case, one of the two annular electrodes is connected to the positive electrode wire 13, and the other is connected to the negative electrode wire 14.

[0079] In a preferred embodiment, the first annular electrode 31 is connected to the positive electrode wire 13, and the second annular electrode 32 is connected to the negative electrode wire 14. The gap between the protrusion 301 of the first annular electrode 31 and the second annular electrode 32 is smaller than the gap between other areas between the two annular electrodes. When the first annular electrode 31 is energized, the current enters the first annular electrode 31 from the positive electrode, generating a shock wave at the protrusion 301. Then, the current enters the second annular electrode 32. The protrusion 301 is the point where the shock wave occurs, so that the point where the shock wave occurs can be predicted.

[0080] In a preferred embodiment, one or more protrusions 301 may be provided as needed. When multiple protrusions 301 are provided, the shock wave generated each time the power is applied can occur sequentially on different protrusions 301, thereby reducing the wear on a certain protrusion 301. When a certain annular electrode is provided with multiple protrusions 301, adjacent protrusions 301 may be arranged at equal or unequal distances, which is not specifically limited in this embodiment.

[0081] In a preferred embodiment, the electrode assembly further includes an electrode bridge, at least a portion of which is made of conductive material. The electrode bridge is disposed between two adjacent annular electrodes. For ease of explanation, the electrode bridge disposed between the first annular electrode 31 and the second annular electrode 32 is defined as the first electrode bridge 33. Figure 7 .

[0082] Preferably, the first electrode bridge 33 is provided with gaps between itself and the first annular electrode 31 and the second annular electrode 32 respectively. The first annular electrode 31 is connected to the positive electrode wire 13, and the second annular electrode 32 is connected to the negative electrode wire 14. The first electrode bridge 33 is not connected to any wires. The purpose of not connecting the wires is to reduce the complicated wiring process without affecting the discharge of the shock wave.

[0083] In a preferred embodiment, at least one protrusion 301 is provided at both ends of the first electrode bridge 33, and one end of the first annular electrode 31 adjacent to the first electrode bridge 33 and one end of the second annular electrode 32 adjacent to the first electrode bridge 33 are smooth, that is, no protrusion 301 is provided on the first annular electrode 31 and the second annular electrode 32.

[0084] In another preferred embodiment, the first annular electrode 31 and the second annular electrode 32 are provided with protrusions 301 on the sides adjacent to the first electrode bridge 33. The first electrode bridge 33 acts as a bridge in the middle, and the shock wave is generated at the protrusions 301. Specifically, the protrusions 301 provided on the first annular electrode 31 may or may not correspond to the protrusions 301 provided on the first electrode bridge 33; the protrusions 301 provided on the second annular electrode 32 may or may not correspond to the protrusions 301 provided on the first electrode bridge 33.

[0085] This invention further provides a shockwave balloon, which includes an elongated member and the aforementioned electrode assembly.

[0086] Furthermore, this embodiment of the invention provides a shockwave balloon, such as... Figure 1 The shockwave balloon includes an elongated component, which in a preferred embodiment is a catheter 10 that is delivered into the human body through a blood vessel. During surgery, the proximal end 11 of the catheter 10 is outside the body and preferably has a handle connected to a power source. The surgeon controls the catheter 10 through the handle so that its distal end 20 enters the human body.

[0087] Preferably, the catheter 10 is a flexible multi-lumen tube, with a balloon at its distal end 20. The inner lumen of the catheter 10 is used for inserting a guidewire, and the channel between the bottom lumen and the outer lumen is used for perfusion fluid to inflate the balloon. Preferably, the balloon has two states: collapsed and inflated. It is in a collapsed state during delivery within the body, and inflates upon reaching the lesion site through perfusion of contrast agent, thus becoming visible in the imaging system.

[0088] Preferably, the balloon has imaging rings 12 at both axial ends to facilitate doctors in determining the actual position of the balloon in the medical imaging system.

[0089] Preferably, since patients have different ages, genders, heights, weights, lesion locations, and lesion conditions, in order to ensure that the balloon can fit well with the lesion and play its role, the specific specifications and dimensions of the catheter 10 and the balloon can be adapted or selected according to the actual situation, and are not limited here.

[0090] In a preferred embodiment, the materials of the catheter 10 and the balloon can be any material disclosed in the prior art, without any specific limitation.

[0091] Preferably, an electrode assembly 30 is disposed within the area of ​​the catheter 10 covered by the balloon, and the electrode assembly 30 covers the outer periphery of the catheter.

[0092] Preferably, the electrode assembly 30 is made of a high-melting-point alloy. Under the instantaneous high-temperature environment during the generation of high-voltage pulses and breakdown discharge, the high-melting-point alloy can maintain its stability and is not easily melted or deformed, ensuring the structural integrity and normal function of the electrode assembly 30. At the same time, the high-melting-point alloy generally also has good conductivity, which can effectively conduct high-voltage pulse current and ensure the generation and transmission efficiency of shock waves.

[0093] Optionally, the electrode assembly 30 may be made of tungsten, tungsten alloy, rhenium, rhenium alloy, tantalum, tantalum alloy, molybdenum, molybdenum alloy, iridium, iridium alloy, niobium alloy, titanium, titanium alloy, high entropy alloy, iron-based superalloy, nickel-based superalloy, intermetallic compound or refractory metal alloy. This embodiment does not limit the specific composition of the material, and those skilled in the art can make flexible adjustments as needed.

[0094] In a preferred embodiment, the electrode assembly 30 includes at least two annular electrodes. The annular electrodes can be in the form of a closed ring structure or an open ring structure. When the annular electrodes are configured as an open ring structure, the opening positions of adjacent annular electrodes can be correspondingly set or staggered. Preferably, the annular electrodes include at least a first annular electrode 31 and a second annular electrode 32, and a gap is provided between the first annular electrode 31 and the second annular electrode 32.

[0095] In a preferred embodiment, at least one end of at least one annular electrode is a complete circle with its circumference surface perpendicular to the axis of the annular electrode. The other end may be configured as a circumference surface forming a non-right angle with the axis of the annular electrode. In this case, the other end of the annular electrode is an inclined surface. Figure 5 and Figure 6 Alternatively, both ends of the ring electrode are configured as a complete circle.

[0096] In a preferred embodiment, the first annular electrode 31 has at least one protrusion 301 on the side adjacent to the second annular electrode 32, or the second annular electrode 32 has at least one protrusion 301 on the side adjacent to the first annular electrode 31. The first annular electrode 31 is connected to the positive electrode wire 13, and the second annular electrode 32 is connected to the negative electrode wire 14. The wires are connected to the annular electrodes by welding, and the annular electrodes are conductive. The gap between the protrusion 301 of the first annular electrode 31 and the second annular electrode 32 is smaller than the gap in other areas between the two annular electrodes. When the first annular electrode 31 is energized, current enters the first annular electrode 31 from the positive electrode, generating a shock wave at the protrusion 301. Then, the current enters the second annular electrode 32. The protrusion 301 is the point where the shock wave occurs, thus making the point where the shock wave occurs predictable. It is preferable to provide multiple protrusions 301, so that each shock wave is generated sequentially on different protrusions 301, thereby reducing the wear and tear on the protrusions 301.

[0097] In a preferred embodiment, protrusions 301 are correspondingly provided on the first annular electrode 31 and the second annular electrode 32. The protrusions 301 on each annular electrode can be arranged equidistantly or unequally around the circumference. The protrusions 301 between the first annular electrode 31 and the second annular electrode 32 can be arranged facing each other or staggered. That is, the directional distribution of each pair of axially opposite protrusions 301 on the circumference can be adjusted according to requirements. Due to the large curvature of the surface of the protrusions 301, the local electric field around the protrusions 301 is significantly enhanced. At the same time, the gap between the protrusions 301 is the shortest, making it easier to generate discharge breakdown. This causes the conductive liquid between the protrusions 301 to be ionized and generate discharge, thereby generating shock waves. By adjusting the directional distribution of multiple pairs of protrusions 301 on the circumference, the shock waves emitted by each group of annular electrodes in series discharge can be clearly controlled in multiple directions, improving the efficiency of shock wave emission and making the shock wave therapy effect better.

[0098] In a preferred embodiment, a protrusion 301 is provided only on the first annular electrode 31, and the protrusion 301 is disposed on the side adjacent to the first annular electrode 31 and the second annular electrode 32. In this case, even if the protrusion 301 is provided on only one annular electrode, the relative distance between the protrusion 301 and the other annular electrode can be reduced, thereby realizing discharge at the protrusion 301. Optionally, the protrusions 301 on the first annular electrode 31 can be arranged circumferentially at equal or unequal intervals. In this embodiment, the number of protrusions 301 is not specifically limited. Those skilled in the art can provide one or more as needed.

[0099] In another preferred embodiment, a protrusion 301 is provided only on the second annular electrode 32, and the protrusion 301 is disposed on the side adjacent to the first annular electrode 31. In this case, even if the protrusion 301 is provided on only one annular electrode, the relative distance between the protrusion 301 and the other annular electrode can be reduced, thereby realizing discharge at the protrusion 301. Optionally, the protrusions 301 on the second annular electrode 32 can be arranged circumferentially at equal or unequal intervals. In this embodiment, the number of protrusions 301 is not specifically limited. Those skilled in the art can provide one or more as needed.

[0100] like Figure 2As shown, in a preferred embodiment, the annular electrode includes at least a first annular electrode 31, a second annular electrode 32, and a first electrode bridge 33. At least a portion of the first electrode bridge 33 is made of conductive material 302. The first electrode bridge 33 is disposed in the gap between the first annular electrode 31 and the second annular electrode 32, and gaps are provided between the first electrode bridge 33 and both the first annular electrode 31 and the second annular electrode 32. Preferably, the first annular electrode 31 is connected to the positive electrode wire 13, the second annular electrode 32 is connected to the negative electrode wire 14, and the first electrode bridge 33 is not connected to any wire. The purpose of not connecting the first electrode bridge 33 to any wire is to reduce the complexity of wiring without affecting the generation of the shock wave discharge.

[0101] In a preferred embodiment, the shock wave is generated in the gap between the first electrode bridge 33 and the first annular electrodes 31 and the second annular electrodes 32 on both sides. The first electrode bridge 33 in the middle is not provided with a protrusion 301, but is only used for intermediate transition, so that the current enters the second annular electrode 32 from the first annular electrode 31 through the first electrode bridge 33.

[0102] In a preferred embodiment, at least one end of the first electrode bridge 33 is a complete circumference, or at least one end of the first electrode bridge is provided with a protrusion 301.

[0103] Preferably, the first annular electrode 31 and the second annular electrode 32 have protrusions 301 on their sides adjacent to the first electrode bridge 33. The first electrode bridge 33 acts as a bridge in the middle, and the shock wave is generated at the protrusions 301. Since the electrode assembly itself is a very small structure, requiring all the protrusions 301 to correspond to each other would be very difficult to install. However, by setting the first electrode bridge 33 in the middle, the protrusions 301 of the first annular electrode 31 and the second annular electrode 32 can be corresponding or not, which reduces the installation difficulty and cost, and has significant practical application value.

[0104] In a preferred embodiment, the first annular electrode 31 and the second annular electrode 32 have multiple protrusions 301 on the sides adjacent to the first electrode bridge 33. Both ends of the first electrode bridge 33 also have multiple protrusions 301. The position of one protrusion 301 corresponds to the protrusion 301 on the first annular electrode 31, and the position of the other protrusion 301 corresponds to the protrusion 301 on the second annular electrode 32. This eliminates the need to consider protrusion alignment during electrode assembly, simplifying installation. Furthermore, since the first electrode bridge 33 is not connected to any wires, an electrode assembly can generate shock waves through two gaps without changing the number of wires, reducing wire distribution and increasing the number of shock wave generation points. Figure 3As shown, in another preferred embodiment, the electrode assembly 30 includes a first annular electrode 31, a second annular electrode 32, and a first electrode bridge 33. The first electrode bridge 33 is disposed between the first annular electrode 31 and the second annular electrode 32. Multiple protrusions 301 are provided on both sides of the first electrode bridge 33. The multiple protrusions 301 are all concentrated on one annular electrode, which simplifies the electrode structure. Since the first electrode bridge 33 is between the two annular electrodes, the current flows from the positive first annular electrode 31 through the first electrode bridge 33 and then into the second annular electrode 32. A shock wave is generated at the protrusions 301 of the first electrode bridge 33. Such an electrode can reduce the processing difficulty and manufacturing cost; at the same time, it is easy to install.

[0105] Preferably, in Figure 3 In the described embodiment, the protrusion 301 may be provided on only one side of the first electrode bridge 33, such as the side near the first annular electrode 31 or the side near the second annular electrode 32, or it may be provided on both sides. When both sides of the first electrode bridge 33 are provided with protrusions 301, the protrusions 301 provided on both sides of the first electrode bridge 33 may be provided correspondingly or staggered. The protrusions 301 provided on the same side may be provided at equal intervals in the circumferential direction or at unequal intervals in the circumferential direction.

[0106] like Figure 7 As shown, in a preferred embodiment, no protrusions 301 are provided on the first annular electrode 31 and the second annular electrode 32. Instead, a protrusion 301 is provided on both sides of the first electrode bridge 33 along its axial direction. The protrusions 301 on both sides are distributed at 180° around the circumference. One protrusion 301 generates a shock wave with the first annular electrode 31, and the other protrusion 301 generates a shock wave with the second annular electrode 32. This eliminates the need to consider the alignment of the protrusions 301 during electrode assembly, simplifying the installation of the electrode assembly. This distribution of protrusions 301 ensures more uniform shock wave generation in the circumferential direction, resulting in more uniform discharge and more uniform axial force on the calcified blood vessel, increasing the safety of the device. Furthermore, it reduces the corrosive effect of discharge on each electrode and increases the number of discharge cycles. Compared to simply providing the first annular electrode 31 and the second annular electrode 32, the additional provision of the first electrode bridge 33 offers at least the following advantages:

[0107] On the one hand, since each electrode assembly 30 consists of three electrodes: a first annular electrode 31, a second annular electrode 32, and a first electrode bridge 33, the first electrode bridge 33 is not connected to a wire, and the first annular electrode 31 and the second annular electrode 32 are connected to the positive and negative wires respectively, each electrode assembly is subjected to breakdown discharge through two gaps. Under the condition of the same pulse energy input to the power supply module, the discharge energy is localized, which can reduce the corrosive effect of discharge on the electrode, so as to facilitate more discharges and extend the service life of the electrode.

[0108] On the other hand, due to the breakdown discharge between electrode rings, the most favorable discharge channel is always selected. The discharge position or direction can be intervened through structural design (such as protrusion 301) and spacing adjustment. Increasing the number of (electrode ring) gaps is equivalent to increasing the number of discharge channels. By setting protrusion 301 on the electrode ring or electrode bridge, the discharge direction can be increased more effectively, thereby achieving control over the discharge direction.

[0109] refer to Figure 11 In a preferred embodiment, the two ends of the first electrode bridge 33 are made of conductive material 302, and the middle part is made of non-conductive material 303.

[0110] refer to Figure 12 In another preferred embodiment, each end of the first electrode bridge 33 is provided with at least one protrusion 301, the protrusions 301 at both ends are made of conductive material 302, and the protrusions 301 at both ends are electrically connected through conductive material 302, while other areas are made of non-conductive material 303.

[0111] refer to Figure 13 In another embodiment, at least one protrusion 301 is provided at each end of the first electrode bridge 33. The protrusions 301 at both ends are made of conductive material 302, while the other areas are made of non-conductive material.

[0112] Regardless of how the conductive material 302 and the non-conductive material 303 of the first electrode bridge 33 are arranged, the first electrode bridge 33 is not connected to any wires.

[0113] Figures 11 to 13 The electrode bridge in the device uses part of a conductive material and part of a non-conductive material. The non-conductive material can be made of materials such as plastic or rubber, which can increase the flexibility of the electrode and make the shock wave balloon pass through better.

[0114] refer to Figure 8 — Figure 10 , Figure 8 The electrode assembly includes a first annular electrode 31 and a second annular electrode 32. Neither electrode has a protrusion 301, and the edges of both electrode rings are smooth. Figure 9 The electrode assembly includes a first annular electrode 31 and a second annular electrode 32. Two protrusions 301 on each electrode are symmetrically distributed at 180°, with the protrusions 301 facing each other. Figure 10The electrode assembly includes a first annular electrode 31, a second annular electrode 32, and a first electrode bridge 33. The two protrusions 301 on a single electrode are symmetrically distributed at 180°. The protrusions of the first annular electrode 31 and the second annular electrode 32 are staggered at 90° and face the first electrode bridge 33 in the middle respectively. Under the same test conditions (voltage 3000V). Figure 8 The electrode assembly 30 shown has an average of 200 discharge cycles, a discharge energy (i.e., the maximum sound pressure of each discharge) greater than 50 atm, and a single discharge direction. Figure 9 The electrode assembly 30 shown has an average of 200 discharge cycles, a discharge energy greater than 50 atm, and discharge directions in two directions. Figure 10-13 The electrode assembly 30 shown has an average discharge count greater than 300 times, a discharge energy greater than 50 atm, and discharge directions of 2 to 4 directions; among which... Figure 11-13 The discharge direction basically follows the guiding direction of the electrode bridge, which makes the release of the shock wave more uniform and balanced. It should also be noted that... Figure 11-13 The use of conductive materials for all or part of the electrode bridges in the process increases the number of discharges and guides the discharge direction. Figure 11-13 The implementation method is based on the reference implementation method.

[0115] like Figure 4 As shown, in a preferred embodiment, the electrode assembly 30 includes a first annular electrode 31, a second annular electrode 32, a first electrode bridge 33, and a second electrode bridge 34. The first electrode bridge 33 and the second electrode bridge 34 are disposed between the first annular electrode 31 and the second annular electrode 32. Preferably, the first annular electrode 31 is connected to the positive electrode wire 13, the second annular electrode 32 is connected to the negative electrode wire 14, and neither the first electrode bridge 33 nor the second electrode bridge 34 is connected to any wire.

[0116] In a preferred embodiment, the first annular electrode 31 and the second annular electrode 32 at both ends do not have protrusions 301, while the first electrode bridge 33 and / or the second electrode bridge 34 in the middle have multiple protrusions 301. Shock waves are generated at the protrusions 301, preventing shock waves from forming at the solder joint, thus making the solder joint more stable. Furthermore, since multiple protrusions 301 are provided, each shock wave is generated sequentially at different protrusions 301, which reduces wear on the protrusions 301.

[0117] Preferably, the protrusion 301 can be provided only on the first electrode bridge 33. In this case, the protrusion 301 can be provided on the side adjacent to the second electrode bridge 34 or on the side adjacent to the second annular electrode 32. Alternatively, the protrusion 301 can be provided only on the second electrode bridge 34. In this case, the protrusion can be provided only on the side adjacent to the first electrode bridge 33 or on the side adjacent to the first annular electrode 31.

[0118] In a preferred embodiment, when both the first electrode bridge 33 and the second electrode bridge 34 are provided with protrusions 301, the protrusions 301 on the first electrode bridge 33 are disposed on the side adjacent to the second electrode bridge 34, and the protrusions 301 on the second electrode bridge 34 are disposed on the side adjacent to the first electrode bridge 33. The axially adjacent protrusions 301 can be disposed correspondingly or staggered. The protrusions 301 disposed on the same side can be disposed at equal intervals in the circumferential direction or at unequal intervals in the circumferential direction.

[0119] In another preferred embodiment, when both the first electrode bridge 33 and the second electrode bridge 34 are provided with protrusions 301, the protrusions 301 on the first electrode bridge 33 are disposed on the side adjacent to the first annular electrode 31, and the protrusions 301 on the second electrode bridge 34 are disposed on the side adjacent to the second annular electrode 32. The axially adjacent protrusions 301 can be disposed correspondingly or staggered. The protrusions 301 disposed on the same side can be disposed at equal intervals in the circumferential direction or at unequal intervals in the circumferential direction.

[0120] In a preferred embodiment, the first electrode bridge 33 and the second electrode bridge 34 located in the middle do not have protrusions 301, while the first annular electrode 31 and / or the second annular electrode 32 located at both ends have multiple protrusions 301. Shock waves are generated at the protrusions 301, avoiding the generation of shock waves at the solder joint, thus making the solder joint more stable. Furthermore, since multiple protrusions 301 are provided, each shock wave is generated sequentially at different protrusions 301, which can reduce wear on the protrusions 301.

[0121] In a preferred embodiment, the protrusion 301 may be provided only on the first annular electrode 31 or only on the second annular electrode 32. When both the first annular electrode 31 and the second annular electrode 32 are provided with protrusions 301, the protrusions 301 on the two can be positioned correspondingly or staggered. The protrusions 301 on the same side can be circumferentially equidistant or circumferentially unequally equidistant.

[0122] In a preferred embodiment, a protrusion 301 is provided on one side of the first electrode bridge 33 adjacent to the first annular electrode 31, and a protrusion 301 is provided on one side of the second electrode bridge 34 adjacent to the first electrode bridge 33.

[0123] In a preferred embodiment, a protrusion 301 is provided on one side of the second electrode bridge 34 adjacent to the second annular electrode 32, and a protrusion 301 is provided on one side of the first electrode bridge 33 adjacent to the second electrode bridge 34.

[0124] In a preferred embodiment, a protrusion 301 is provided on the side of the first electrode bridge 33 adjacent to the first annular electrode 31, and a protrusion 301 is provided on the side of the second annular electrode 32 adjacent to the second electrode bridge 34.

[0125] In a preferred embodiment, a protrusion 301 is provided on the side of the first annular electrode 31 adjacent to the first electrode bridge 33, and a protrusion 301 is provided on the side of the second electrode bridge 34 adjacent to the second annular electrode 32.

[0126] Preferably, the distribution angle of the plurality of protrusions 301 can be π, π / 2, π / 3, or π / 4, etc. The protrusions 301 are evenly distributed on each annular electrode, or they can be unevenly distributed. One, two, three, or four protrusions 301 can be provided. Figure 14 As shown, the protrusion 301 can be configured in various shapes, such as fan-shaped, circular, arc-shaped, semi-circular, conical, quadrilateral, and triangular.

[0127] In some disclosed embodiments, the annular electrode in the electrode assembly 30 is made of a conductive material, such as 304 steel or 316 steel, or a metal material with imaging function, such as a platinum-iridium alloy. The annular electrode is bonded to the catheter with an adhesive. Optionally, multiple electrode assemblies 30 described above can be provided on the catheter of a shockwave balloon.

[0128] In some publicly disclosed embodiments, such as Figures 1 to 4 As shown, the gap between adjacent annular electrodes is between 0.1 and 2 mm; the gap between an annular electrode and the protrusion 301 of another annular electrode, or the gap between the protrusion 301 of one annular electrode and the protrusion 301 of another annular electrode, is smaller than the gap between the annular electrodes. Because the gap of the protrusion 301 is smaller than the gap between the annular electrodes, the shock wave is generated at the protrusion 301. Each shock wave causes some wear on the electrode, making the gap of the protrusion 301 that generates the shock wave slightly larger. Therefore, each time a shock wave is generated at one protrusion 301, the next time it is generated at another protrusion 301. This allows the location of the shock wave to be cyclical, so that the location of the shock wave is controllable and the damage to the protrusion 301 is evenly distributed. This allows the electrode assembly to generate multiple shock waves in one operation, ensuring the stability of the electrode assembly and making the shock wave balloon safer.

[0129] Specifically, in any of the above embodiments, it is no longer limited whether the electrodes in the electrode assembly 30 have the same melting point. Each electrode is preferably made of a high melting point alloy, and the melting points of different electrodes may be the same or different.

[0130] The flexible electrodes described in this invention play an important role in the field of medical devices due to their unique structural features and advantages. They are typically composed of conductive materials (such as metals, alloys, or conductive polymers) and flexible substrate materials (such as silicone, polyvinyl alcohol (PVA), polyester (PET), polyimide (PI), polyethylene naphthalate (PEN), polydimethylsiloxane (PDMS), paper, textile materials, etc.). This structure allows the electrodes to fit closely to medical device devices and / or the human body surface or lumen, adapting to the deformation of organs such as skin, blood vessels, internal organs, and muscles.

[0131] The balloon is pierced by a catheter, with the electrode assembly looped around the catheter. This simple structure allows for easy bonding and provides good stability, avoiding the problems of electrode-to-structure clogging and uneven, inconsistent shock wave intensity found in existing technologies. Furthermore, the energy of the shock wave can be precisely controlled by altering the gap between the protrusions of the annular electrodes or by changing the voltage, pulse width, and other discharge parameters of the high-voltage pulse power supply module, ensuring the safety and effectiveness of shock wave therapy.

[0132] The above description is merely a preferred embodiment of this utility model, but the protection scope of this utility model is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in this utility model should be included within the protection scope of this utility model. Therefore, the protection scope of this utility model should be determined by the scope of the claims.

Claims

1. An electrode assembly for being disposed on the outer periphery of an elongated member, characterized in that, The electrode assembly includes at least two axially arranged annular electrodes with a gap between adjacent annular electrodes, and the annular electrodes are respectively connected to a power source. At least one end of at least one annular electrode is a complete circle; A gap is provided between two adjacent annular electrodes; at least one electrode bridge is provided between adjacent annular electrodes. At least a portion of the electrode bridge is made of conductive material, and there are gaps between the electrode bridge and each adjacent annular electrode. The annular electrode is configured to generate an electric arc discharge and form a shock wave in the gap when a voltage is applied, and the shock wave can propagate in the medium surrounding the elongated member; the gap is configured to contain a conductive medium to facilitate the formation of the electric arc discharge.

2. The electrode assembly according to claim 1, characterized in that, The electrode bridge is not connected to a power source.

3. The electrode assembly according to claim 1, characterized in that, At least one end of at least one of the ring electrodes is a complete circle.

4. The electrode assembly according to claim 1, characterized in that, At least one of the ring electrodes is configured as a closed ring structure or an open ring structure.

5. The electrode assembly according to claim 1, characterized in that, The distance between adjacent annular electrodes is 0.1-5 mm.

6. The electrode assembly according to claim 1, characterized in that, At least one of the annular electrodes is provided with at least one protrusion, the protrusion being disposed in the gap between adjacent annular electrodes, and the distance between the protrusion and the adjacent annular electrode is less than the distance between other areas between adjacent annular electrodes.

7. The electrode assembly according to claim 6, characterized in that, At least one protrusion is provided at both ends of the electrode bridge.

8. The electrode assembly according to any one of claims 1 to 6, characterized in that, The ends of the annular electrode adjacent to the electrode bridge are smooth.

9. The electrode assembly according to any one of claims 1 to 6, characterized in that, The annular electrode is a flexible electrode.

10. A shockwave balloon, characterized in that, It includes an elongated member for entering a human body lumen, the distal end of the elongated member being the end that enters the human body, and the distal end of the elongated member being provided with an electrode assembly as described in any one of claims 1-8.

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