Electrode assembly and shock wave balloon

Abstract

The invention relates to an electrode assembly and a shock wave balloon, the electrode assembly is composed of a plurality of annular electrodes, the electrode assembly comprises at least two annular electrodes which are axially arranged, each annular electrode is of a closed annular structure or an open annular structure, and a gap and an electrode bridge are arranged between every two adjacent annular electrodes; and at least one end of the at least one annular electrode is a complete circumference. The invention aims to solve the problems of few discharge times of shock waves of the shock wave balloon and positioning direction of the shock waves.

Description

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 has increased year by year. Among them, vascular calcification is a common vascular pathological manifestation and has attracted widespread attention. In recent years, an emerging technology for the treatment of vascular calcification, intravascular shock wave lithotripsy, has emerged in clinical applications abroad. The basic principle of this technology is to apply high-voltage pulses to the electrodes in the conductive liquid to produce breakdown discharge. The liquid cavitation occurs under the action of the electric field, forming bubbles that burst instantly, thereby generating shock waves to break up the calcified lesions. When in use, the shock wave balloon is first pushed into the calcified part of the blood vessel, and it is expanded at low pressure to fit the blood vessel wall, and then the high-voltage pulse power supply is started to generate intermittent shock waves, thereby breaking up the superficial and deep calcified plaques in the blood vessel, and finally the balloon is further expanded to fully expand the blood vessel lumen to achieve the purpose of treatment. Summary of the invention

[0003] 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 the shock waves are generated multiple times. In addition, the discharge point of the shock wave mostly occurs on the path with the smallest impedance between the electrodes.

[0004] The present invention also aims to provide an electrode assembly and a shock wave balloon, which are used to solve the problem of low number of shock wave discharges and / or the positioning direction of the shock wave and / or to improve the wiring efficiency and / or improve the passability of the shock wave balloon.

[0005] To achieve the above 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;

[0006] At least one electrode bridge is arranged between adjacent annular electrodes. At least a part of the electrode bridge is made of conductive material. There is a gap between the electrode bridge and adjacent annular electrodes.

[0007] 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 a gap distance between the protrusion and an adjacent annular electrode is smaller than other gap distances between adjacent annular electrodes.

[0008] 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;

[0009] At least the first ring-shaped electrode is provided with at least one protrusion, and the protrusion is provided on the side adjacent to the second ring-shaped electrode; or at least the second ring-shaped electrode is provided with at least one protrusion, and the protrusion is provided on the side adjacent to the first ring-shaped electrode.

[0010] As a preferred technical solution, the first annular electrode is provided with a plurality of protrusions in the circumferential direction, and adjacent protrusions are arranged at equal or unequal distances; or, the second annular electrode is provided with a plurality of protrusions in the circumferential direction, and adjacent protrusions are arranged at equal or unequal distances.

[0011] 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.

[0012] As a preferred technical solution, at least one end of at least one electrode bridge is a smooth circle;

[0013] Or at least one end of at least one electrode bridge is provided with a protrusion;

[0014] Alternatively, at least one end of the electrode bridge is provided with at least one protrusion, and at least one end of the adjacent annular electrode is smooth.

[0015] As a preferred technical solution, the electrode bridge includes a first electrode bridge, the first electrode bridge is provided with a plurality of protrusions, the protrusions are arranged on the side opposite to the first annular electrode, and / or the protrusions are arranged on the side opposite to the first electrode bridge and the second annular electrode.

[0016] As a preferred technical solution, circumferentially adjacent protrusions are arranged at equal and / or unequal distances;

[0017] When both sides of the first electrode bridge are provided with protrusions, the axially adjacent protrusions are arranged alternately and / or axially correspondingly.

[0018] As a preferred technical solution, at least one protrusion is provided at both ends of the electrode bridge, and both ends of adjacent annular electrodes are smooth.

[0019] 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. Gaps are respectively provided between the second electrode bridge and the first electrode bridge and between the second annular electrodes.

[0020] The 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 entering the human body, and the distal end of the slender member is provided with an electrode assembly as described in any one of the above items.

[0021] The third aspect of the present invention provides the use of the above-mentioned shock wave generating device and / or shock wave balloon in treating vascular calcification and / or calculi in the lumen of a living body.

[0022] 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.

[0023] A fourth aspect of the present invention provides the use of the shock wave generating device and / or shock wave balloon in treating stent malapposition.

[0024] 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.

[0025] During the operation, the interventional doctor may find that the intravascular stent is poorly adhered to the wall through imaging methods such as angiography, OCT, and IVUS. The doctor may 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.

[0026] The shock wave generating device and / or shock wave balloon can be applied to the application of digestive tract stents, urinary system stents, ENT stents, reproductive system stents, respiratory system stents with poor wall adhesion, and so on.

[0027] The present invention also aims to provide an electrode assembly and a shock wave balloon, which are used to solve the problem of low number of shock wave discharges and / or the positioning direction of the shock wave and / or to improve the wiring efficiency and / or improve the passability of the shock wave balloon.

[0028] 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 a closed ring structure or an open ring structure, wherein a gap is provided between two adjacent ring electrodes; at least one end of at least one ring electrode is a complete circle; 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; the electrode bridge is not connected to the wire.

[0029] 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.

[0030] 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.

[0031] The present invention also aims to provide an electrode assembly and a shock wave balloon, which are used to solve the problem of low number of shock wave discharges and / or the positioning direction of the shock wave and / or to improve the wiring efficiency and / or improve the passability of the shock wave balloon.

[0032] To achieve the above-mentioned purpose, another aspect of the present invention provides an electrode assembly, which is arranged on the outer periphery of a slender member, and the electrode assembly includes at least two axially arranged ring electrodes, wherein the ring electrodes are a closed ring structure or an open ring structure, wherein 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; and there is a protrusion at each end of the electrode bridge.

[0033] As a preferred technical solution, the two protrusions are 180° opposite to each other.

[0034] As a preferred technical solution, the electrode bridge is not connected to a wire.

[0035] 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.

[0036] The electrode assembly provided by the embodiment of the present invention can be applied to a shock wave balloon. The electrode assembly is composed of a plurality of annular electrodes, which are arranged on the periphery of the slender member and bonded by an adhesive. At least one protrusion is arranged at the gap between the annular electrode and / or the electrode bridge, and the gap between the protrusion and the adjacent annular electrode is smaller than the gap between other positions of the annular electrodes. That is, the gap between the protrusion and the adjacent annular electrode is the smallest, which is smaller than the gap between two normal annular electrodes. Since the gap between the protrusion and the annular electrode is smaller than the gap between the annular electrodes, the position where the shock wave is generated is at the protrusion, and a shock wave has a certain consumption on the electrode, so that the gap of the protrusion generating the shock wave will be slightly larger, so each time a shock wave is generated at a protrusion, the next time a shock wave is generated at another protrusion, so that the position where the shock wave is generated can be cyclically reciprocated, that is, the position where the shock wave is generated can be controlled, and the damage to the protrusion caused by the shock wave can be evenly distributed, so that the electrode assembly can emit multiple shock waves in one operation, ensuring the stability and durability of the electrode assembly, and making the shock wave balloon safer.

[0037] At the same time, the raised portion serves as a generating point of the shock wave, thereby avoiding the occurrence of the shock wave phenomenon between the wire and the ring electrode welding point, and making the wire connection more stable.

[0038] The protrusions arranged at the gaps between the annular electrodes and / or the electrode bridges can guide the direction in which the shock wave occurs, so that the propagation of the shock wave in the balloon is evenly distributed in two or more directions.

[0039] 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

[0040] 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 explain the present invention and do not constitute improper limitations on the present invention. In the drawings:

[0041] Figure 1 is a schematic diagram of a shock wave balloon in an embodiment of the present invention;

[0042] Figure 2 is a schematic diagram of an electrode assembly in a shock wave balloon according to an embodiment of the present invention;

[0043] Figure 3 is a schematic diagram of an electrode assembly in a shock wave balloon according to an embodiment of the present invention;

[0044] Figure 4 is a schematic diagram of an electrode assembly in a shock wave balloon according to an embodiment of the present invention;

[0045] Figure 5 is a schematic diagram of an electrode assembly in an embodiment of the present invention;

[0046] Figure 6 is a schematic diagram of an electrode assembly in an embodiment of the present invention;

[0047] Figure 7 is a schematic diagram of a preferred electrode assembly in an embodiment of the present invention;

[0048] Figure 8 is a schematic diagram of an electrode assembly in an embodiment of the present invention;

[0049] Fig. 9 is a schematic diagram of an electrode assembly in an embodiment of the present invention;

[0050] Fig.10 is a schematic diagram of an electrode assembly in an embodiment of the present invention;

[0051] Fig.11is a schematic diagram of an electrode assembly in an embodiment of the present invention;

[0052] Fig.12 is a schematic diagram of an electrode assembly in an embodiment of the present invention;

[0053] Fig.13 is a schematic diagram of an electrode assembly in an embodiment of the present invention;

[0054] Fig.14 Schematic diagram of a protrusion in an embodiment of the present invention.

[0055] Description of reference numerals:

[0056] 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 annular electrode 31 , second annular electrode 32 , first electrode bridge 33 , second electrode bridge 34 . DETAILED DESCRIPTION

[0057] In order to make the purpose, technical solution and advantages of the present invention clearer, the technical solution of the present invention will be clearly and completely described below in conjunction with the specific embodiments of the present invention and the corresponding drawings. In the description of the present invention, it should be noted that the term "or" is usually used in the sense of including "and / or", unless the content clearly indicates otherwise.

[0058] 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 it can be indirectly connected 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 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.

[0059] In the field of interventional medical device technology, the direction close 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 an object such as a cylinder or a tube is defined as the axial direction. The radial direction refers to the direction passing through the central axis in the radial plane, for example, the straight line direction along the diameter or radius, or the straight line direction perpendicular to the central axis.

[0060] Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0061] Reference below Figure 1 The shock wave balloon provided in an embodiment of the present invention is described. The shock wave balloon includes a slender member. In a preferred embodiment, the slender member is a catheter 10, which is transported into the human body through a blood vessel. During surgery, the proximal end 11 of the catheter 10 is outside the body. A handle is preferably provided and 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.

[0062] Preferably, the catheter 10 is a flexible multi-lumen tube, and a balloon is provided at its distal end 20. The inner lumen of the catheter 10 is used to pass a guide wire, and the channel between the bottom lumen and the outer lumen is used to perfuse fluid to expand the balloon. Preferably, the balloon has two states: collapsed and expanded. It is in a collapsed state when transported in the human body, and can be expanded by perfusing a contrast agent after reaching the lesion, and can be visualized in an imaging system.

[0063] Preferably, developing rings 12 are provided at both axial ends of the balloon to help doctors determine the actual position of the balloon in a medical imaging system.

[0064] Preferably, since patients have different ages, genders, heights, weights, lesion locations and lesion conditions, in order to ensure that the balloon and the lesion can fit well 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.

[0065] 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.

[0066] Preferably, an electrode assembly 30 is disposed in the area of ​​the catheter 10 covered by the balloon, and the electrode assembly 30 covers the outer circumference of the catheter.

[0067] 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.

[0068] 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 technicians in this field can flexibly adjust it according to needs.

[0069] In a preferred embodiment, the electrode assembly 30 includes at least two annular electrodes, and the annular electrodes may be in a closed annular structure or an open annular structure. When the annular electrodes are configured as an open annular structure, the opening positions of adjacent annular electrodes may be set correspondingly or staggered. Preferably, the annular electrodes include at least a first annular electrode 31 and a second annular electrode 32, and a gap is set between the first annular electrode 31 and the second annular electrode 32.

[0070] 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 circumferential surface having an angle with the axis of the annular electrode that is not a right angle. In this case, the other end of the annular electrode is an inclined surface, referring to Figure 5 and Figure 6 , or, both ends of the ring electrode are configured as a complete circle.

[0071] In a preferred embodiment, the first ring electrode 31 is provided with at least one protrusion 301 on the side adjacent to the second ring electrode 32, or the second ring electrode 32 is provided with at least one protrusion 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, and the ring electrodes can be conductive. The gap between the protrusion 301 of the first ring electrode 31 and the second ring electrode 32 is smaller than the gap in other areas between the two ring electrodes. When the first ring electrode 31 is energized, the current enters the first ring electrode 31 from the positive electrode, and a shock wave is generated at the protrusion 301. Then, the current enters the second ring 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. It is preferred that a plurality of protrusions 301 are provided, and each time a shock wave is generated, it is generated in different protrusions 301 in sequence, so as to reduce the loss of the protrusions 301 .

[0072] In a preferred embodiment, the first annular electrode 31 and the second annular electrode 32 are provided with protrusions 301 correspondingly. The protrusions 301 provided on each annular electrode can be arranged equidistantly or unequally in the circumference. The protrusions 301 between the first annular electrode 31 and the second annular electrode 32 can be arranged opposite to each other or staggered, that is, the circumferential direction distribution of each pair of axially opposite protrusions 301 can be adjusted according to the needs. Due to the large curvature of the structural 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, which makes it easier to produce discharge breakdown, so that the conductive liquid between the protrusions 301 is ionized to produce discharge, and then generate shock waves. By adjusting the circumferential direction distribution of multiple pairs of protrusions 301, each group of serially discharged annular electrodes can be clearly controlled to emit shock waves in multiple directions, thereby improving the efficiency of shock wave emission and making the shock wave treatment effect better.

[0073] In a preferred embodiment, the protrusion 301 is provided only on the first annular electrode 31, and the protrusion 301 is arranged 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 circumferentially equidistant or unequally spaced. In this embodiment, the number of the protrusions 301 is not specifically limited, and those skilled in the art can set one or more protrusions as needed.

[0074] In another preferred embodiment, the protrusion 301 is provided only on the second annular electrode 32, and the protrusion 301 is arranged 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 circumferentially equidistant or unequally spaced. In this embodiment, the number of the protrusions 301 is not specifically limited, and those skilled in the art can set one or more protrusions as needed.

[0075] like Figure 2As shown, in a preferred embodiment, the ring electrode is provided with at least a first ring electrode 31, a second ring electrode 32 and a first electrode bridge 33, at least a part of the first electrode bridge 33 is made of a conductive material 302, the first electrode bridge 33 is arranged in the gap between the first ring electrode 31 and the second ring electrode 32, and a gap is arranged between the first electrode bridge 33 and the first ring electrode 31 and the second ring electrode 32 respectively; preferably, the first ring electrode 31 is connected to the positive electrode wire 13, the second ring electrode 32 is connected to the negative electrode wire 14, and the first electrode bridge 33 is not connected to the wire. The function of the first electrode bridge 33 not being connected to the wire is to reduce the cumbersome process of wiring without affecting the occurrence of the discharge of the shock wave.

[0076] 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, which 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.

[0077] 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 .

[0078] Preferably, the first annular electrode 31 and the second annular electrode 32 are provided with a protrusion 301 on the side adjacent to the first electrode bridge 33, and the first electrode bridge 33 acts as a bridge in the middle, and the shock wave is generated at the protrusion 301. Since the electrode assembly itself is a very small structure, it is very difficult to install the protrusions 301 if the protrusions 301 are required to correspond to each other. However, the first electrode bridge 33 is provided in the middle, so that the protrusions 301 of the first annular electrode 31 and the second annular electrode 32 can correspond or not correspond, which reduces the difficulty of installation and the cost of installation, and has obvious practical application value.

[0079] In a preferred embodiment, the first annular electrode 31 and the second annular electrode 32 are provided with a plurality of protrusions 301 on the sides adjacent to the first electrode bridge 33, and both ends of the first electrode bridge 33 are also provided with a plurality of protrusions 301, and the positions of the protrusions 301 on one side correspond to the protrusions 301 provided on the first annular electrode 31, and the positions of the protrusions 301 on the other side correspond to the protrusions 301 provided on the second annular electrode 32. In this way, there is no need to consider the alignment of the protrusions when assembling the electrode assembly, making the installation of the electrode assembly easier; and, the first electrode bridge 33 in the middle is not connected to the wires, so that one electrode assembly can have two gaps to generate shock waves, and the number of wires remains unchanged, which can reduce the distribution of the wires and increase the locations where shock waves are generated. Figure 3As shown, 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 passing through the first electrode bridge 33 and then entering 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 manufacturing cost; at the same time, it is easy to install.

[0080] Preferably, Figure 3 In the described embodiment, the raised portion 301 may be disposed on only one side of the first electrode bridge 33, such as the side close to the first annular electrode 31, or the side close to the second annular electrode 32, or may be disposed on both sides. When raised portions 301 are disposed on both sides of the first electrode bridge 33, the raised portions 301 disposed on both sides of the first electrode bridge 33 may be disposed correspondingly or may be disposed alternately. The raised portions 301 disposed on the same side may be disposed equidistantly or unequally spaced circumferentially.

[0081] like Figure 7 As shown, in a preferred embodiment, no protrusion 301 is provided on the first annular electrode 31 and the second annular electrode 32, and a protrusion 301 is provided on both axial sides of the first electrode bridge 33, and the protrusions 301 on both sides are distributed at 180° on the circumference, and the protrusion 301 on one side generates a shock wave with the first annular electrode 31, and the protrusion 301 on the other side generates a shock wave with the second annular electrode 32, so that when assembling the electrode assembly, there is no need to consider the alignment of the protrusion 301, making the installation of the electrode assembly simpler; this distribution of the protrusion 301 can make the shock wave generated in the circumferential direction more uniform, and the discharge is also more uniform, so that the axial force of the calcified blood vessel is uniform, which increases the safety of the device, and can reduce the corrosion effect of the discharge on each electrode, and increase the number of discharges of the electrode. Compared with only setting the first annular electrode 31 and the second annular electrode 32, when the first electrode bridge 33 is further provided, its advantages are at least:

[0082] On the one hand, since each group of electrode assemblies 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 group of electrodes is subjected to breakdown discharge by two gaps. When the same pulse energy is input to the power module, the discharge energy is localized, which can reduce the corrosion effect of the discharge on the electrode, so as to facilitate more discharges and extend the service life of the electrode;

[0083] 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), spacing adjustment, etc., and increasing the number of (electrode ring) gaps means increasing the number of discharge channels. By setting the protrusion 301 on the electrode exchange or electrode bridge, the discharge direction can be more effectively increased and the control of the discharge direction can be achieved.

[0084] refer to Fig.11 In a preferred embodiment, both ends of the first electrode bridge 33 are made of conductive material 302 , and the middle portion is made of non-conductive material 303 .

[0085] refer to Fig.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 a 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 a non-conductive material 303 .

[0086] refer to Fig.13 In another embodiment, at least one protrusion 301 is disposed at each end of the first electrode bridge 33 , and the protrusions 301 at the two ends are made of a conductive material 302 , while the other regions are made of a non-conductive material.

[0087] 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.

[0088] Figures 11 to 13 The electrode bridge is made of a conductive material in part and a non-conductive material in part. The non-catheter material can be plastic, rubber or the like, which can increase the flexibility of the electrode and improve the permeability of the shock wave balloon.

[0089] refer to Figure 8 — Fig.10 , Figure 8 The electrode assembly includes a first ring electrode 31 and a second ring electrode 32, both electrodes have no protrusion 301, and the edges of both electrode rings are smooth; Fig. 9 The electrode assembly includes a first annular electrode 31 and a second annular electrode 32, and two protrusions 301 on a single electrode are symmetrically distributed at 180 degrees, and the protrusions 301 of the two electrodes are facing each other. Fig.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 discharge frequency of 200 times, a discharge energy (i.e., the maximum sound pressure of each discharge) of greater than 50 atm, and a single discharge direction; Fig. 9 The electrode assembly 30 shown has an average discharge number of 200 times, a discharge energy greater than 50 atm, and a discharge direction in two directions; Figure 10-13 The electrode assembly 30 shown has an average discharge frequency of more than 300 times, a discharge energy of more than 50 atm, and a discharge direction of 2 to 4 directions; Figure 11-13 The discharge direction is basically in accordance with the guiding direction of the electrode bridge, which can make the release of shock waves more uniform and balanced. At the same time, it is also necessary to explain Figure 11-13 The electrode bridge in the apparatus is entirely made of conductive material and / or partially made of conductive material, which has the effect of increasing the number of discharges and guiding the discharge direction. Figure 11-13 The implementation is the reference implementation.

[0090] like Figure 4 As shown, 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.

[0091] In a preferred embodiment, the first annular electrode 31 and the second annular electrode 32 disposed at both ends are not provided with the protrusion 301, and the first electrode bridge 33 and / or the second electrode bridge 34 disposed in the middle are provided with a plurality of protrusions 301. The shock wave is generated at the protrusion 301, thereby avoiding the generation of the shock wave at the welding point, thereby making the welding point more stable. In addition, a plurality of protrusions 301 are provided, and each time the shock wave is generated, it is generated at different protrusions 301 in sequence, which can reduce the loss of the protrusion 301.

[0092] Preferably, the raised portion 301 can be only arranged on the first electrode bridge 33, in which case the raised portion 301 can be arranged on the edge adjacent to the second electrode bridge 34, or on the edge adjacent to the second ring-shaped electrode 32; the raised portion 301 can also be only arranged on the second electrode bridge 34, in which case the raised portion can be only arranged on the edge adjacent to the first electrode bridge 33, or on the edge adjacent to the first ring-shaped electrode 31.

[0093] 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, and the protrusions 301 arranged on the same side can be arranged equidistantly or unequally circumferentially.

[0094] 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 edge adjacent to the first annular electrode 31, and the protrusion 301 on the second electrode bridge 34 is arranged on the edge 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 edge can be arranged equidistantly or unequally circumferentially.

[0095] In a preferred embodiment, the first electrode bridge 33 and the second electrode bridge 34 disposed in the middle are not provided with the protrusion 301, and the first annular electrode 31 and / or the second annular electrode 32 disposed at both ends are provided with multiple protrusions 301. The shock wave is generated at the protrusion 301, which avoids the generation of shock waves at the welding point, thereby making the welding point more stable. In addition, multiple protrusions 301 are provided, and each time the shock wave is generated, it is generated in different protrusions 301 in turn, which can reduce the loss of the protrusion 301.

[0096] In a preferred embodiment, the protrusion 301 can be only arranged on the first ring-shaped electrode 31, or can be only arranged on the second ring-shaped electrode 32. When the protrusion 301 is provided on both the first ring-shaped electrode 31 and the second ring-shaped electrode 32, the protrusions 301 on the two can be arranged in corresponding positions or staggered. The protrusions 301 arranged on the same side can be arranged at equal distances in the circumferential direction or at unequal distances in the circumferential direction.

[0097] 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 .

[0098] 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 .

[0099] 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 annular electrode 32 adjacent to the second electrode bridge 34 .

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

[0101] Preferably, the distribution angle of the plurality of protrusions 301 may be π, π / 2, π / 3 or π / 4, etc. The protrusions 301 may be evenly distributed on each annular electrode, or unevenly distributed. The number of protrusions 301 may be 1, 2, 3 or 4. Fig.14 As shown, the protrusion 301 can be set to a variety of shapes, such as fan-shaped, circular, arc-shaped, semicircular, conical, quadrilateral, triangle, etc.

[0102] 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, and the ring electrode is bonded to the catheter by an adhesive. Optionally, a plurality of the above-mentioned electrode assemblies 30 can be arranged on the catheter of a shock wave balloon.

[0103] In some disclosed embodiments, Figures 1 to 4 As shown, the gap between adjacent ring electrodes is between 0.1 and 2 mm; the gap between the ring electrode and the protrusion 301 of another ring electrode or the gap between the protrusion 301 of one ring electrode and the protrusion 301 of another ring electrode is smaller than the gap between the ring electrodes. Since the gap of the protrusion 301 is smaller than the gap between the ring electrodes, the position where the shock wave is generated is at the protrusion 301, and the occurrence of a shock wave has a certain consumption on the electrode, so that the gap of the protrusion 301 generating the shock wave will be slightly larger, so each time a shock wave is generated at a protrusion 301, the next time a shock wave is generated at another protrusion 301, so that the position where the shock wave is generated can be cyclically reciprocated, that is, the position where the shock wave is generated can be controlled, and the damage to the protrusion 301 caused by the shock wave can be evenly distributed, so that 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.

[0104] 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.

[0105] The balloon is penetrated by a catheter, and the electrode assembly ring is worn on the catheter. The structure is simple, easy to bond, and has good stability. It avoids the problem of easy blockage of the through hole of the electrode pair structure in the prior art, and the uneven and sometimes strong and sometimes weak shock waves. The energy of the shock wave can also be accurately controlled by changing the gap between the annular electrode protrusions, or changing the discharge parameters such as the voltage and pulse width of the high-voltage pulse power module, to ensure the safety and effectiveness of shock wave therapy.

[0106] The above is only a preferred specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any changes or substitutions that can be easily thought of by a person skilled in the art within the technical scope disclosed by the present invention should be included in the protection scope of the present invention. Therefore, the protection scope of the present invention should be based on the protection scope of the claims.

Claims

1. An electrode assembly, arranged on the periphery of a slender member, characterized in that: The electrode assembly comprises 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; 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 is a gap between the electrode bridge and adjacent annular electrodes.

2. The electrode assembly according to claim 1, characterized in that: At least one of the annular electrodes is provided with at least one protrusion, and the protrusion is arranged at a gap between the annular electrodes, and a gap distance between the protrusion and an adjacent annular electrode is smaller than other gap distances between adjacent annular electrodes.

3. The electrode assembly according to claim 2, characterized in that: The annular electrode comprises a first annular electrode and a second annular electrode, and a gap is provided between the first annular electrode and the second annular electrode; At least the first annular electrode is provided with at least one protrusion, and the protrusion is arranged on a side adjacent to the second annular electrode; or, At least the second ring-shaped electrode is provided with at least one protrusion, and the protrusion is arranged on a side adjacent to the first ring-shaped electrode.

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

5. The electrode assembly according to claim 4, characterized in that: The first annular electrode and the second annular electrode are both provided with the protrusions, and the protrusions adjacent to each other in the circumferential direction are arranged with equal spacing and / or unequal spacing, and the protrusions adjacent to each other in the axial direction are arranged oppositely and / or staggered.

6. The electrode assembly according to any one of claims 1 to 5, characterized in that: At least one end of at least one of the electrode bridges is a smooth circle; Or at least one end of at least one of the electrode bridges is provided with a protrusion; Alternatively, at least one end of the electrode bridge is provided with at least one protrusion, 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 opposite to the first annular electrode of the first electrode bridge, and / or the protrusions are arranged on the side opposite to the second annular electrode of the first electrode bridge.

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

9. The electrode assembly according to claim 6, characterized in that: At least one protrusion is provided at two ends of the electrode bridge, and two ends of adjacent annular electrodes are smooth.

10. The electrode assembly according to any one of claims 1 to 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. Gaps are respectively provided between the second electrode bridge and the first electrode bridge and between the second annular electrodes.

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

12. Use of the shock wave generating device and / or shock wave balloon according to claim 11 in treating vascular calcification and / or luminal calculi in a living body.

13. The use according to claim 12, characterized in that: The 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.

14. Use of the shock wave generating device and / or shock wave balloon according to claim 11 in treating stent malapposition.

15. The use according to claim 14, characterized in that: The stent includes one or more of a digestive tract stent, a vascular stent, a urinary system stent, an ENT stent, a reproductive system stent, and a respiratory system stent.

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