Electrode assembly and shock wave balloon

Abstract

Provided are an electrode assembly (30) and a shock wave balloon, wherein the electrode assembly (30) is composed of a plurality of annular electrodes (31, 32). The electrode assembly (30) comprises at least two axially arranged annular electrodes (31, 32), wherein the annular electrodes (31, 32) are of a closed annular structure or an open annular structure; a gap and electrode bridges (33, 34) are provided between two adjacent annular electrodes (31, 32); and at least one end of at least one of the annular electrodes (31, 32) is a complete circumference.

Description

Electrode assembly and shock wave balloon Technical Field

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

[0002] With the accelerated pace of life and unhealthy lifestyles, the incidence of vascular diseases is increasing year by year. Vascular calcification, a common vascular pathology, has garnered widespread attention. In recent years, an emerging technology for treating vascular calcification—intravascular shock wave lithotripsy—has gained recognition in clinical practice abroad. The basic principle of this technology is to apply high-voltage pulses to electrodes within a conductive liquid, generating a breakdown discharge. The electric field induces cavitation in the liquid, forming bubbles that instantly collapse, generating shock waves that fragment calcified tissue. In use, a shock wave balloon is first advanced into the calcified area of ​​the vessel and inflated at low pressure to conform to the vessel wall. Then, a high-voltage pulsed power supply is activated, generating intermittent shock waves that fragment superficial and deep calcified plaques within the vessel. Finally, the balloon is further inflated to fully expand the vessel lumen, achieving the therapeutic goal.

[0003] Summary of the Invention

[0004] After many experiments, it was found that the electrodes of the shock wave balloon are usually made of metal materials. The shock waves are generated by the electrodes, and the electrodes will be consumed after the shock waves are generated, especially after multiple shock waves are generated. The consumption is more serious; and the discharge point of the shock wave mostly occurs on the path with the smallest impedance between the electrodes.

[0005] The present invention also aims to provide an electrode assembly and a shock wave balloon for solving the problem of low shock wave discharge times and / or shock wave positioning direction and / or improving wiring efficiency and / or improving the passability of the shock wave balloon.

[0006] To achieve the above-mentioned object, the first aspect of the present invention provides an electrode assembly, which is arranged on the periphery of a slender member, and the electrode assembly includes at least two axially arranged annular electrodes, wherein the annular electrodes are a closed annular structure or an open annular structure, wherein a gap is provided between two adjacent annular electrodes; at least one end of at least one annular electrode is a complete circumference;

[0007] 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 gaps are provided between the electrode bridges and adjacent annular electrodes.

[0008] As a preferred technical solution, at least one annular electrode is provided with at least one protrusion, which is arranged at a gap between the annular electrodes, and the gap distance between the protrusion and the adjacent annular electrode is smaller than other gap distances between adjacent annular electrodes.

[0009] As a preferred technical solution, the annular electrode includes a first annular electrode and a second annular electrode, and a gap is provided between the first annular electrode and the second annular electrode;

[0010] At least the first annular electrode is provided with at least one protrusion, and the protrusion is provided on the side adjacent to the second annular electrode; or at least the second annular electrode is provided with at least one protrusion, and the protrusion is provided on the side adjacent to the first annular electrode.

[0011] As a preferred technical solution, the first annular electrode is provided with several convex portions in the circumference, and adjacent convex portions are arranged at equal or unequal distances; or, the second annular electrode is provided with several convex portions in the circumference, and adjacent convex portions are arranged at equal or unequal distances.

[0012] As a preferred technical solution, both the first annular electrode and the second annular electrode are provided with protrusions, circumferentially adjacent protrusions are arranged equidistantly and / or unequally, and axially adjacent protrusions are arranged oppositely and / or staggered.

[0013] As a preferred technical solution, at least one end of at least one electrode bridge is a smooth circle;

[0014] Or at least one end of at least one electrode bridge is provided with a protrusion;

[0015] Alternatively, at least one end of the electrode bridge is provided with at least one protrusion, and at least one end of the adjacent ring-shaped electrode is smooth.

[0016] As a preferred technical solution, the electrode bridge includes a first electrode bridge, which is provided with several protrusions, which are arranged on the side opposite to the first annular electrode and / or the protrusions are arranged on the side opposite to the second annular electrode.

[0017] As a preferred technical solution, circumferentially adjacent protrusions are arranged at equal and / or unequal distances;

[0018] When both sides of the first electrode bridge are provided with protrusions, axially adjacent protrusions are arranged alternately and / or axially correspondingly.

[0019] As a preferred technical solution, at least one protrusion is provided at both ends of the electrode bridge, and both ends of adjacent ring electrodes are smooth.

[0020] 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 respectively provided between the second electrode bridge and the first electrode bridge and between the second annular electrodes.

[0021] A second aspect of the present invention provides a shock wave generating device and / or shock wave balloon, comprising a slender member for entering a biological lumen, the distal end of the slender member being the end that enters the human body, and the distal end of the slender member being provided with an electrode assembly as described above.

[0022] A third aspect of the present invention provides use of the shock wave generating device and / or shock wave balloon in treating vascular calcification and / or calculi in a biological lumen.

[0023] The above-mentioned vascular calcification includes one or more of peripheral vascular calcification, coronary artery calcification, carotid artery calcification, intracranial artery calcification, aortic arch calcification, and valve calcification.

[0024] A fourth aspect of the present invention provides use of the shock wave generating device and / or shock wave balloon in treating stent malapposition.

[0025] The above-mentioned stents include one or more of the following: digestive tract stents, intravascular stents, urinary system stents, ENT stents, reproductive system stents, and respiratory system stents.

[0026] During surgery, interventional doctors may find that the intravascular stent is poorly adhered to the wall through imaging methods such as angiography, OCT, and IVUS. They can operate the shock wave generating device or shock wave balloon described in the present invention to emit shock waves, thereby promoting the adhesion of the stent to the blood vessel wall and promoting the endothelialization process.

[0027] The shock wave generating device and / or shock wave balloon can be used in the treatment of poorly adhered stents in the digestive tract, urinary system, ENT, reproductive system, and respiratory system.

[0028] The present invention also aims to provide an electrode assembly and a shock wave balloon for solving the problem of low shock wave discharge times and / or shock wave positioning direction and / or improving wiring efficiency and / or improving the passability of the shock wave balloon.

[0029] To achieve the above-mentioned purpose, another aspect of the present invention provides an electrode assembly, which is arranged on the periphery of a slender member, and the electrode assembly includes at least two axially arranged ring electrodes, wherein the ring electrodes are closed ring structures or open ring structures, and a gap is provided between two adjacent ring electrodes; at least one end of at least one ring electrode is a complete circumference; at least one electrode bridge is provided between adjacent ring electrodes, and at least a part of the electrode bridge is made of conductive material, and there is a gap between the electrode bridge and the adjacent ring electrodes; the electrode bridge is not connected to the wire.

[0030] As a preferred technical solution, there is a protrusion at each end of the electrode bridge. More preferably, the two protrusions are 180 degrees opposite to each other.

[0031] As a preferred technical solution, the ends of the first annular electrode and the second annular electrode adjacent to the electrode bridge are smooth circles.

[0032] The present invention also aims to provide an electrode assembly and a shock wave balloon for solving the problem of low shock wave discharge times and / or shock wave positioning direction and / or improving wiring efficiency and / or improving the passability of the shock wave balloon.

[0033] To achieve the above-mentioned purpose, another aspect of the present invention provides an electrode assembly, which is arranged on the periphery of a slender member, and the electrode assembly includes at least two axially arranged ring electrodes, wherein the ring electrodes are closed ring structures or open ring structures, and a gap is provided between two adjacent ring electrodes; at least one end of at least one ring electrode is a complete circumference; at least one electrode bridge is provided between adjacent ring electrodes, at least a part of the electrode bridge is made of conductive material, and there is a gap between the electrode bridge and the adjacent ring electrodes; there is a protrusion at each end of the electrode bridge.

[0034] As a preferred technical solution, the two protrusions are 180° opposite to each other.

[0035] As a preferred technical solution, the electrode bridge is not connected to a wire.

[0036] As a preferred technical solution, the ends of the first annular electrode and the second annular electrode adjacent to the electrode bridge are smooth circles.

[0037] The electrode assembly provided by an embodiment of the present invention can be applied to a shock wave balloon. The electrode assembly is composed of a plurality of ring electrodes, which are arranged on the outer periphery of a slender member and bonded by an adhesive. At least one protrusion is provided at the gap between the ring electrodes and / or the electrode bridge. The gap between the protrusion and the adjacent ring electrodes is smaller than the gap between the ring electrodes at other locations. That is, the gap between the protrusion and the adjacent ring electrodes is the smallest and smaller than the gap between two normal ring electrodes. Since the gap between the protrusion and the ring electrodes is smaller than the gap between the ring electrodes, the location where the shock wave is generated is at the protrusion. The occurrence of a shock wave has a certain consumption on the electrode, so that the gap between the protrusion generating the shock wave will be slightly larger. Therefore, each time a shock wave is generated at one protrusion, the next shock wave is generated at another protrusion. In this way, the location where the shock wave is generated can be cyclically repeated, that is, the location where the shock wave is generated can be controlled, and the damage caused by the shock wave to the protrusion can be evenly distributed. This allows the electrode assembly to emit multiple shock waves during a single operation, ensuring the stability and durability of the electrode assembly and making the shock wave balloon safer.

[0038] At the same time, the raised portion serves as the generating point of the shock wave, thereby avoiding the occurrence of the shock wave phenomenon at the welding point between the wire and the annular electrode, making the wire connection more stable.

[0039] The protrusions provided at the gaps between the annular electrodes and / or the electrode bridge can guide the direction in which the shock wave is generated, so that the propagation of the shock wave in the balloon is evenly distributed in two or more directions.

[0040] Based on the following detailed description of specific embodiments of the present invention in conjunction with the accompanying drawings, those skilled in the art will become more aware of the above and other objects, advantages and features of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for describing the embodiments, which constitute a part of the present invention. The exemplary embodiments of the present invention and their descriptions are provided to explain the present invention and do not constitute an undue limitation of the present invention. In the drawings:

[0042] FIG1 is a schematic diagram of a shock wave balloon according to an embodiment of the present invention;

[0043] FIG2 is a schematic diagram of an electrode assembly in a shock wave balloon according to an embodiment of the present invention;

[0044] FIG3 is a schematic diagram of an electrode assembly in a shock wave balloon according to an embodiment of the present invention;

[0045] FIG4 is a schematic diagram of an electrode assembly in a shock wave balloon according to an embodiment of the present invention;

[0046] FIG5 is a schematic diagram of an electrode assembly in an embodiment of the present invention;

[0047] FIG6 is a schematic diagram of an electrode assembly in an embodiment of the present invention;

[0048] FIG7 is a schematic diagram of a preferred electrode assembly according to an embodiment of the present invention;

[0049] FIG8 is a schematic diagram of an electrode assembly in an embodiment of the present invention;

[0050] FIG9 is a schematic diagram of an electrode assembly in an embodiment of the present invention;

[0051] FIG10 is a schematic diagram of an electrode assembly in an embodiment of the present invention;

[0052] FIG11 is a schematic diagram of an electrode assembly in an embodiment of the present invention;

[0053] FIG12 is a schematic diagram of an electrode assembly in an embodiment of the present invention;

[0054] FIG13 is a schematic diagram of an electrode assembly in an embodiment of the present invention;

[0055] FIG14 is a schematic diagram of a raised portion in an embodiment of the present invention.

[0056] Description of reference numerals:

[0057] Catheter 10, proximal end 11, developing ring 12, positive wire 13, negative wire 14, distal end 20, electrode assembly 30, protrusion 301, conductive material 302, non-conductive material 303, first ring electrode 31, second ring electrode 32, first electrode bridge 33, second electrode bridge 34. DETAILED DESCRIPTION

[0058] To make the objectives, technical solutions, and advantages of the present invention more clear, the technical solutions of the present invention will be clearly and completely described below in conjunction with specific embodiments of the present invention and corresponding drawings. In the description of the present invention, it should be noted that the term "or" is generally used in the sense of including "and / or" unless the content clearly indicates otherwise.

[0059] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or an indirect connection through an intermediate medium, or it can be internal communication between two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to the specific circumstances. In addition, in the description of this application, the terms "first", "second", etc. are only used to distinguish the description and cannot be understood as indicating or implying relative importance.

[0060] In the field of interventional medical device technology, the direction closest to the operator is generally defined as the proximal end, and the direction away from the operator is defined as the distal end. The direction of the central axis of objects such as cylinders and tubes is defined as the axial direction. The radial direction refers to the direction passing through the central axis in a radial plane, for example, along a straight line of diameter or radius, or perpendicular to the central axis.

[0061] Obviously, the embodiments described are only some of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0062] The shock wave balloon provided by an embodiment of the present invention is described below with reference to FIG1 . The shock wave balloon includes a slender member. In a preferred embodiment, the slender member is a catheter 10, which is delivered into the human body through a blood vessel. During surgery, the proximal end 11 of the catheter 10 is outside the body. The catheter 10 is preferably provided with a handle connected to a power source. The operator controls the catheter 10 through the handle so that the distal end 20 thereof enters the human body.

[0063] Preferably, catheter 10 is a flexible multi-lumen tube with a balloon disposed at its distal end 20. The inner lumen of catheter 10 is used to pass a guidewire, and the channel between the bottom lumen and the outer lumen is used to inject fluid to expand the balloon. Preferably, the balloon has two states: collapsed and inflated. During delivery within the human body, the balloon is in a collapsed state. Upon reaching the lesion, it can be inflated by infusion of a contrast agent, allowing visualization in an imaging system.

[0064] Preferably, developing rings 12 are provided at both axial ends of the balloon to facilitate doctors to determine the actual position of the balloon in a medical imaging system.

[0065] 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 to function, the specific specifications and sizes of the catheter 10 and the balloon can be adaptively adjusted or selected according to actual conditions, and are not limited here.

[0066] In a preferred embodiment, the material of the catheter 10 and the balloon can be any material disclosed in the prior art, and is not specifically limited here.

[0067] Preferably, an electrode assembly 30 is provided in the area of ​​the catheter 10 covered by the balloon, and the electrode assembly 30 covers the outer circumference of the catheter.

[0068] 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, thereby 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 electrical conductivity and can effectively conduct high-voltage pulse current, thereby ensuring the generation and transmission efficiency of shock waves.

[0069] 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, niobium alloy, titanium, titanium alloy, high entropy alloy, iron-based high-temperature alloy, nickel-based superalloy, intermetallic compound or refractory metal alloy. This embodiment no longer limits the specific components of the material, and those skilled in the art can flexibly adjust it according to needs.

[0070] In a preferred embodiment, the electrode assembly 30 includes at least two ring electrodes, and the ring electrodes can be a closed ring structure or an open ring structure. When the ring electrodes are configured as an open ring structure, the opening positions of adjacent ring electrodes can be set correspondingly or staggered. Preferably, the ring electrodes include at least a first ring electrode 31 and a second ring electrode 32, and a gap is set between the first ring electrode 31 and the second ring electrode 32.

[0071] In a preferred embodiment, at least one end of at least one annular electrode is a complete circle, and the circumferential surface is perpendicular to the axis of the annular electrode, and the other end can be configured as a circular surface having an angle that is not a right angle to the axis of the annular electrode. In this case, the other end of the annular electrode is an inclined surface, refer to Figures 5 and 6, or, both ends of the annular electrode are configured as a complete circle.

[0072] In a preferred embodiment, the first ring electrode 31 is provided with at least one raised portion 301 on the side adjacent to the second ring electrode 32, or the second ring electrode 32 is provided with at least one raised portion 301 on the side adjacent to the first ring electrode 31. The first ring electrode 31 is connected to the positive wire 13, and the second ring electrode 32 is connected to the negative wire 14. The wires and the ring electrodes are connected by welding, making the ring electrodes conductive. The gap between the raised portion 301 of the first ring electrode 31 and the second ring electrode 32 is smaller than the gap between the other areas of the two ring electrodes. When the first ring electrode 31 is energized, current enters the first ring electrode 31 from the positive electrode, generating a shock wave at the raised portion 301. The current then enters the second ring electrode 32. The raised portion 301 is the point where the shock wave is generated, making the point where the shock wave is generated predictable. It is preferred that a plurality of raised portions 301 are provided, and each time a shock wave is generated, it is generated in different raised portions 301 in sequence to reduce the loss of the raised portions 301 .

[0073] In a preferred embodiment, protrusions 301 are correspondingly provided on the first and second annular electrodes 31, 32. The protrusions 301 provided on each annular electrode can be arranged equidistantly or unequally spaced around the circumference. The protrusions 301 between the first and second annular electrodes 31, 32 can be arranged directly opposite each other or staggered. That is, the circumferential distribution of each pair of axially opposed protrusions 301 can be adjusted as needed. Due to the large surface curvature of the protrusions 301, the local electric field around the protrusions 301 is significantly enhanced. Simultaneously, the gaps between the protrusions 301 are minimized, making it more likely for discharge breakdown to occur. This ionizes the conductive liquid between the protrusions 301, generating discharges and, in turn, shock waves. By adjusting the circumferential distribution of multiple pairs of protrusions 301, each set of series-connected annular electrodes can be clearly controlled to emit shock waves in multiple directions, improving the efficiency of shock wave emission and achieving a more effective shock wave therapy.

[0074] In a preferred embodiment, the protrusion 301 is provided only on the first annular electrode 31, and the protrusion 301 is provided on the edge 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 to achieve discharge at the protrusion 301; optionally, the protrusions 301 on the first annular electrode 31 can be provided circumferentially at equal or unequal intervals. In this embodiment, the number of the protrusions 301 is not specifically limited, and those skilled in the art can provide one or more protrusions as needed.

[0075] In another preferred embodiment, the protrusion 301 is provided only on the second annular electrode 32, and the protrusion 301 is provided on the edge of the second annular electrode 32 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 to achieve discharge at the protrusion 301; optionally, the protrusions 301 on the second annular electrode 32 can be provided circumferentially at equal or unequal intervals. In this embodiment, the number of the protrusions 301 is no longer specifically limited, and those skilled in the art can provide one or more protrusions as needed.

[0076] As shown in FIG2 , in a preferred embodiment, the ring electrode comprises at least a first ring electrode 31, a second ring electrode 32, and a first electrode bridge 33. At least a portion of the first electrode bridge 33 is made of a conductive material 302. The first electrode bridge 33 is disposed in the gap between the first ring electrode 31 and the second ring electrode 32, with gaps being provided between the first electrode bridge 33 and each of the first and second ring electrodes 31 and 32. Preferably, the first ring electrode 31 is connected to the positive wire 13, the second ring electrode 32 is connected to the negative wire 14, and the first electrode bridge 33 is not connected to any wires. The purpose of not connecting the first electrode bridge 33 to any wires is to reduce the cumbersome wiring process without affecting the discharge of the shock wave.

[0077] In a preferred embodiment, the shock wave is generated in the gap between the first electrode bridge 33 and the first annular electrode 31 and the second annular electrode 32 on both sides. The middle first electrode bridge 33 is not provided with a protrusion 301 and is only used for intermediate transition, so that the current flows from the first annular electrode 31 through the first electrode bridge 33 into the second annular electrode 32.

[0078] 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 .

[0079] Preferably, the first and second annular electrodes 31 and 32 are provided with raised portions 301 on their sides adjacent to the first electrode bridge 33. The first electrode bridge 33 acts as a bridge in the middle, and shock waves are generated at the raised portions 301. Since the electrode assembly itself is a very small structure, requiring all raised portions 301 to correspond to each other would be very difficult to install. However, the intermediate first electrode bridge 33 allows the raised portions 301 of the first and second annular electrodes 31 and 32 to correspond or not, reducing installation difficulty and cost, and having significant practical application value.

[0080] In a preferred embodiment, the first annular electrode 31 and the second annular electrode 32 are provided with multiple protrusions 301 on the sides adjacent to the first electrode bridge 33. Multiple protrusions 301 are also provided on both ends of the first electrode bridge 33. The protrusions 301 on one side correspond to the protrusions 301 provided on the first annular electrode 31, and the protrusions 301 on the other side correspond to the protrusions 301 provided on the second annular electrode 32. This eliminates the need to consider the alignment of the protrusions when assembling the electrode assembly, making installation of the electrode assembly easier. Furthermore, the middle first electrode bridge 33 is not connected to the wires, allowing one electrode assembly to have two gaps for generating shock waves while maintaining the same number of wires. This reduces the distribution of wires and increases the number of locations where shock waves are generated. As shown in Figure 3, in another preferred embodiment, the electrode assembly 30 includes a first ring electrode 31, a second ring electrode 32 and a first electrode bridge 33. The first electrode bridge 33 is arranged between the first ring electrode 31 and the second ring electrode 32. A plurality of protrusions 301 are arranged on both sides of the first electrode bridge 33. The plurality of protrusions 301 are concentrated on one ring electrode, which simplifies the electrode structure. The first electrode bridge 33 is between the two ring electrodes. The current has the positive first ring electrode 31 pass through the first electrode bridge 33 and then enter the second ring electrode 32, generating a shock wave at the protrusion 301 of the first electrode bridge 33. Such an electrode can reduce processing difficulty and reduce production costs; at the same time, it is easy to install.

[0081] Preferably, in the embodiment described in Figure 3, the raised portion 301 can be arranged only on one side of the first electrode bridge 33, such as the side close to the first ring electrode 31, or the side close to the second ring electrode 32, or can be arranged on both sides. When the raised portions 301 are provided on both sides of the first electrode bridge 33, the raised portions 301 arranged on both sides of the first electrode bridge 33 can be arranged correspondingly or staggered. The raised portions 301 arranged on the same side can be arranged equidistantly or unequally spaced circumferentially.

[0082] As shown in FIG7 , in a preferred embodiment, no protrusion 301 is provided on the first annular electrode 31 and the second annular electrode 32. Instead, a protrusion 301 is provided on both axial sides of the first electrode bridge 33. The protrusions 301 on both sides are distributed 180° around the circumference. The protrusion 301 on one side generates a shock wave with the first annular electrode 31, while the protrusion 301 on the other side generates a shock wave with the second annular electrode 32. This eliminates the need to consider the alignment of the protrusions 301 when assembling the electrode assembly, making the installation of the electrode assembly simpler. This distribution of the protrusions 301 can make the shock wave more uniform in the circumferential direction, resulting in more uniform discharge, uniform axial force on the calcified blood vessels, and improve the safety of the device. Furthermore, it can reduce the corrosive effect of discharge on each electrode and increase the number of discharges of the electrodes. Compared to only providing the first annular electrode 31 and the second annular electrode 32, the advantages of further providing the first electrode bridge 33 are at least the following:

[0083] On the one hand, since each electrode assembly 30 is composed of three electrodes, namely the first annular electrode 31, the second annular electrode 32 and the first electrode bridge 33, the first electrode bridge 33 is not connected to the wire, and the first annular electrode 31 and the second annular electrode 32 are connected to the positive and negative wires respectively, each electrode group has two gaps for breakdown discharge. When the same pulse energy is input to the power module, the discharge energy is localized, which can reduce the corrosive effect of the discharge on the electrode, allowing for more discharges and extending the service life of the electrode.

[0084] On the other hand, due to the breakdown discharge between the electrode rings, the channel that is most conducive to discharge is always selected. The discharge position or direction can be intervened by structural design (such as the protrusion 301) and spacing adjustment. Increasing the number of (electrode ring) gaps means increasing the number of discharge channels. By setting the protrusion 301 on the electrode ring or electrode bridge, the discharge direction can be more effectively increased and the discharge direction can be controlled.

[0085] 11 , in a preferred embodiment, both ends of the first electrode bridge 33 are made of a conductive material 302 , and the middle portion is made of a non-conductive material 303 .

[0086] Referring to Figure 12, in another preferred 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, and the protrusions 301 at both ends are conductively connected through the conductive material 302, and the other areas are made of non-conductive material 303.

[0087] 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 a conductive material 302 , while the other regions are made of a non-conductive material.

[0088] No matter 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 wire.

[0089] The electrode bridges in Figures 11 to 13 are made of conductive material in one part and non-conductive material in the other part. The non-catheter material can be plastic, rubber or the like, which can increase the flexibility of the electrode and make the shock wave balloon more passable.

[0090] 8 to 10, the electrode assembly in FIG8 includes a first annular electrode 31 and a second annular electrode 32, both electrodes have no raised portion 301, and the edges of both electrode rings are smooth; the electrode assembly in FIG9 includes a first annular electrode 31 and a second annular electrode 32, and the two raised portions 301 on a single electrode are symmetrically distributed at 180°, and the raised portions 301 of the two electrodes are facing each other; the electrode assembly in FIG10 includes a first annular electrode 31, a second annular electrode 32, and a first electrode bridge 33, and the two raised portions 301 on a single electrode are symmetrically distributed at 180°, and the raised portions 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), the electrode assembly 30 shown in FIG8 The average number of discharges is 200 times, the discharge energy (that is, the maximum sound pressure of each discharge) is greater than 50atm, and the discharge direction is single; the average number of discharges of the electrode assembly 30 shown in Figure 9 is 200 times, the discharge energy is greater than 50atm, and the discharge direction is two directions; the average number of discharges of the electrode assembly 30 shown in Figures 10-13 is greater than 300 times, the discharge energy is greater than 50atm, and the discharge direction is 2 to 4 directions; among them, the discharge direction of Figures 11-13 is basically discharged in accordance with the guidance direction of the electrode bridge, which can make the release of the shock wave more uniform and balanced. At the same time, it is also necessary to explain that the electrode bridges in Figures 11-13 are all made of conductive materials and / or partially made of conductive materials, which have the effect of increasing the number of discharges and guiding the discharge direction. The implementation method of Figures 11-13 is a reference implementation method.

[0091] As shown in Figure 4, in a preferred embodiment, the electrode assembly 30 includes a first ring electrode 31, a second ring electrode 32, a first electrode bridge 33 and a second electrode bridge 34, and the first electrode bridge 33 and the second electrode bridge 34 are arranged between the first ring electrode 31 and the second ring electrode 32. Preferably, the first ring electrode 31 is connected to the positive wire 13, the second ring electrode 32 is connected to the negative wire 14, and the first electrode bridge 33 and the second electrode bridge 34 are not connected to the wires.

[0092] In a preferred embodiment, the first and second annular electrodes 31, 32 at the ends are not provided with raised portions 301. Instead, the first and / or second electrode bridges 33, 34 in the middle are provided with multiple raised portions 301. Generating shock waves at the raised portions 301 prevents shock waves from forming at the weld point, thereby enhancing the weld stability. Furthermore, multiple raised portions 301 are provided, so that each shock wave is generated sequentially at different raised portions 301, reducing wear and tear on the raised portions 301.

[0093] Preferably, the raised portion 301 can be arranged only on the first electrode bridge 33, in which case the raised portion 301 can be arranged on the side adjacent to the second electrode bridge 34, or on the side adjacent to the second ring electrode 32; the raised portion 301 can also be arranged only on the second electrode bridge 34, in which case the raised portion can be arranged only on the side adjacent to the first electrode bridge 33, or on the side adjacent to the first ring electrode 31.

[0094] In a preferred embodiment, when both the first electrode bridge 33 and the second electrode bridge 34 are provided with a protrusion 301, the protrusion 301 on the first electrode bridge 33 is arranged on the side adjacent to the second electrode bridge 34, and the protrusion 301 on the second electrode bridge 34 is arranged on the side adjacent to the first electrode bridge 33. The axially adjacent protrusions 301 can be arranged correspondingly or staggered. The protrusions 301 arranged on the same side can be arranged equidistantly or unequally spaced circumferentially.

[0095] In another preferred embodiment, when both the first electrode bridge 33 and the second electrode bridge 34 are provided with a protrusion 301, the protrusion 301 on the first electrode bridge 33 is arranged on the side adjacent to the first annular electrode 31, and the protrusion 301 on the second electrode bridge 34 is arranged on the side adjacent to the second annular electrode 32. The axially adjacent protrusions 301 can be arranged correspondingly or staggered, and the protrusions 301 arranged on the same side can be arranged equidistantly or unequally circumferentially.

[0096] In a preferred embodiment, the first and second electrode bridges 33 and 34, positioned in the middle, are not provided with raised portions 301. Instead, the first and / or second annular electrodes 31 and 32, positioned at both ends, are provided with multiple raised portions 301. Generating shock waves at the raised portions 301 prevents shock waves from forming at the weld point, thereby enhancing the weld stability. Furthermore, by providing multiple raised portions 301, each shock wave is generated sequentially at different raised portions 301, reducing wear and tear on these portions.

[0097] In a preferred embodiment, the raised portion 301 can be provided only on the first ring electrode 31, or can be provided only on the second ring electrode 32. When the raised portion 301 is provided on both the first ring electrode 31 and the second ring electrode 32, the raised portions 301 on the two can be provided in corresponding positions or can be provided in an alternating manner. The raised portions 301 provided on the same side can be provided at equal intervals or at unequal intervals in the circumferential direction.

[0098] In a preferred embodiment, a protrusion 301 is provided on a side of the first electrode bridge 33 adjacent to the first annular electrode 31 , and a protrusion 301 is provided on a side of the second electrode bridge 34 adjacent to the first electrode bridge 33 .

[0099] In a preferred embodiment, a protrusion 301 is provided on a side of the second electrode bridge 34 adjacent to the second annular electrode 32 , and a protrusion 301 is provided on a side of the first electrode bridge 33 adjacent to the second electrode bridge 34 .

[0100] In a preferred embodiment, a protrusion 301 is provided on a side of the first electrode bridge 33 adjacent to the first annular electrode 31 , and a protrusion 301 is provided on a side of the second annular electrode 32 adjacent to the second electrode bridge 34 .

[0101] In a preferred embodiment, a protrusion 301 is provided on a side of the first annular electrode 31 adjacent to the first electrode bridge 33 , and a protrusion 301 is provided on a side of the second electrode bridge 34 adjacent to the second annular electrode 32 .

[0102] Preferably, the distribution angle of the plurality of protrusions 301 can be π, π / 2, π / 3, or π / 4, etc. The protrusions 301 can be evenly distributed on each annular electrode, or unevenly distributed. The number of protrusions 301 can be 1, 2, 3, or 4. As shown in FIG14 , the protrusions 301 can be arranged in various shapes, such as fan-shaped, circular, arc-shaped, semicircular, conical, quadrilateral, triangular, etc.

[0103] In some disclosed embodiments, the ring electrode in the above-mentioned electrode assembly 30 can be made of a conductive material, such as 304 steel or 316 steel or a metal material with a developing function such as a platinum-iridium alloy. The ring electrode is bonded to the catheter by an adhesive. Optionally, multiple above-mentioned electrode assemblies 30 can be set on the catheter of a shock wave balloon.

[0104] In some disclosed embodiments, as shown in Figures 1 to 4, the gap between adjacent ring electrodes is between 0.1 and 2 mm; the gap between the ring electrode and the raised portion 301 of another ring electrode or the gap between the raised portion 301 of one ring electrode and the raised portion 301 of another ring electrode is smaller than the gap between the ring electrodes. Since the gap of the raised portion 301 is smaller than the gap between the ring electrodes, the position where the shock wave is generated is at the raised portion 301. The occurrence of a shock wave has a certain consumption on the electrode, so that the gap of the raised portion 301 where the shock wave is generated will be slightly larger. Therefore, each time a shock wave is generated at one raised portion 301, the next time a shock wave is generated at another raised portion 301, so that the position where the shock wave is generated can be cyclically repeated, that is, the position where the shock wave is generated can be controlled, and the damage caused by the shock wave to the raised portion 301 can be evenly distributed. In this way, the electrode assembly can emit multiple shock waves in one operation, ensuring the stability of the electrode assembly and making the shock wave balloon safer.

[0105] 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.

[0106] The balloon is inserted through a catheter, and the electrode assembly is looped onto the catheter. This simple structure is easy to bond and provides excellent stability. It also avoids the problems of clogging through the electrode pair structure in existing technologies, which can lead to uneven and fluctuating shock wave generation. By varying the gap between the ring-shaped electrode protrusions or by adjusting discharge parameters such as the voltage and pulse width of the high-voltage pulse power module, the shock wave energy can be precisely controlled, ensuring the safety and effectiveness of shock wave therapy.

[0107] The above description is merely a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any changes or substitutions that can be easily conceived by a person skilled in the art within the technical scope disclosed in the present invention should be included in the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be based on the scope of protection of the claims.

Claims

1. An electrode assembly is disposed on the outer periphery of an elongated member, characterized in that, The electrode assembly includes at least two axially arranged annular electrodes, wherein the annular electrodes are of a closed annular structure or an open-loop structure, and there is a gap between two adjacent annular electrodes; at least one end of at least one of the annular electrodes is a complete circumference; There is at least one electrode bridge between adjacent annular electrodes, at least a part of the electrode bridge is made of a conductive material, and there is a gap between the electrode bridge and the adjacent annular electrodes respectively.

2. The electrode assembly according to claim 1, wherein At least one of the annular electrodes is provided with at least one protrusion, the protrusion is arranged 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.

3. The electrode assembly according to claim 2, characterized in that, The annular electrodes include a first annular electrode and a second annular electrode, and there is a gap between the first annular electrode and the second annular electrode; At least the first annular electrode is provided with at least one of the protrusions, and the protrusion is arranged on the side adjacent to the second annular electrode; or, At least the second annular electrode is provided with at least one of the protrusions, and the protrusion is arranged on the side adjacent to the first annular electrode.

4. The electrode assembly according to claim 3, characterized in that, The first annular electrode is circumferentially provided with a plurality of the protrusions, and the adjacent protrusions are arranged at equal or unequal intervals; or, the second annular electrode is circumferentially provided with a plurality of the protrusions, and the adjacent protrusions are arranged at equal or unequal intervals.

5. The electrode assembly according to claim 4, wherein Both the first annular electrode and the second annular electrode are provided with the protrusions, the circumferentially adjacent protrusions are arranged at equal and / or unequal intervals, and the axially adjacent protrusions are arranged opposite to and / or staggered with each other.

6. The electrode assembly according to any one of claims 1-5, characterized in that, At least one end of at least one of the electrode bridges is a smooth circumference; Or at least one end of at least one of the electrode bridges is provided with a protrusion; Or at least one of the ends of the electrode bridge is provided with at least one of the protrusions, and at least one end of the adjacent annular electrode is smooth.

7. The electrode assembly according to claim 6, characterized in that, The electrode bridge includes a first electrode bridge, the first electrode bridge is provided with a plurality of the protrusions, the protrusions are arranged on the side of the first electrode bridge opposite to the first annular electrode, and / or the protrusions are arranged on the side of the first electrode bridge opposite to the second annular electrode.

8. The electrode assembly according to claim 7, characterized in that, The circumferentially adjacent protrusions are arranged at equal and / or unequal intervals; When both sides of the first electrode bridge are provided with the protrusions, the axially adjacent protrusions are arranged staggered and / or axially corresponding.

9. The electrode assembly according to claim 6, wherein Both ends of the electrode bridge are provided with at least one of the protrusions, and both ends of the adjacent annular electrodes are smooth.

10. The electrode assembly according to any one of claims 1-5, characterized in that, 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 there are gaps between the second electrode bridge and the first electrode bridge and between the second electrode bridge and the second annular electrode respectively.

11. A shock wave generating device and / or a shock wave balloon, comprising an elongate member for entering a body lumen, wherein the distal end of the elongate member is the end for entering the human body, characterized in that, The distal end of the slender member is provided with the electrode assembly according to any one of claims 1-10 above.

12. Use of the shock wave generating device and / or shock wave balloon according to claim 11 in the treatment of vascular calcification and / or biological lumen stones.

13. The application according to claim 12, wherein The vascular calcification includes one or more of peripheral vascular calcification, coronary artery calcification, carotid artery calcification, intracranial artery calcification, aortic arch calcification, and valvular calcification.

14. Use of the shock wave generating device and / or shock wave balloon according to claim 11 in the treatment of poor stent apposition.

15. The application according to claim 14, wherein The stent includes one or more of an endogastric stent, an endovascular stent, a urinary system stent, an otorhinolaryngological stent, a reproductive system stent, and a respiratory system stent.

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