Shockwave emission device and shockwave system

Abstract

Provided are a shockwave emission device and a shockwave system. The shockwave emission device comprises a catheter (1), a balloon (6) and a plurality of electrode assemblies (2, 3), wherein the balloon (6) is sleeved on the catheter (1), the plurality of electrode assemblies (2, 3) are arranged in an inner cavity of the balloon (6), and the plurality of electrode assemblies (2, 3) are sleeved on the catheter (1) and extend along the length of the catheter (1); and the plurality of electrode assemblies (2, 3) are configured into at least two shockwave generation channels, the electrode assemblies (2, 3) in each shockwave generation channel are connected in series, at least one shockwave generation channel comprises three or more electrode assemblies (2), the at least two shockwave generation channels share one electrode line, and the electrode line is a positive electrode line or a negative electrode line. The shockwave generation channels of the shockwave emission device of the present invention share one electrode line, and the electrode assemblies (2, 3) in each shockwave generation channel are connected in series, which enable higher superposition efficiency of shockwave energy and a larger energy coverage area per unit time while reducing the space occupancy rate of electrical wires in the balloon (6) cavity and enhancing the therapeutic effect of the shockwave system.

Description

Shock wave emitting device and shock wave system TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, and in particular to a shock wave emitting device and a shock wave system. BACKGROUND

[0002] The shock wave balloon technology is a new, safe and effective technology for treating heart valves and vascular calcification, and has the advantages of easy operation and balloon tortuosity. In the treatment process, the shock wave balloon is pushed to the treatment area by a catheter, and a medium is filled in the balloon to make the balloon surface contact the treatment area. Then, the energy generator is turned on to make the electrodes in the balloon work and generate high-energy shock wave force. The high-energy shock wave force penetrates the balloon surface into the calcified lesion to be treated, thereby softening the treatment area.

[0003] Currently, the shock wave balloon uses multiple electrode assemblies to achieve greater shock waves. With the increase in the number of electrode assemblies, the shock wave emitting source connected by the electrode assemblies requires higher voltage, which affects the safety performance of the shock wave system. In addition, the number of electrode wires connected to the shock wave emitting source also increases, resulting in a small liquid medium flow volume in the balloon cavity, a slow balloon pressure charging and discharging speed, and further affecting the treatment effect of the shock wave system. SUMMARY

[0004] To solve at least one of the above technical problems, the present application provides an electrode device, a forming method, a shock wave emitting device and a shock wave system.

[0005] According to some embodiments of the present application, a shock wave emitting device is provided, comprising a catheter, a balloon and a plurality of electrode assemblies, the balloon being sleeved on the catheter, the plurality of electrode assemblies being arranged in the inner cavity of the balloon, the plurality of electrode assemblies being sleeved on the catheter and extending along the length direction of the catheter; the plurality of electrode assemblies are arranged into at least two shock wave generating channels, the electrode assemblies of each shock wave generating channel being connected in series, at least one of the shock wave generating channels comprising a plurality of electrode assemblies, the at least two shock wave generating channels sharing one electrode wire, the electrode wire being a positive electrode wire or a negative electrode wire.

[0006] In some possible implementations, the at least two shock wave generating channels comprise a first shock wave generating channel and a second shock wave generating channel, the first shock wave generating channel comprising the electrode assembly at the distal end of the catheter.

[0007] In some possible implementations, the second shock wave generating channel comprises more than three electrode assemblies, and the electrode assemblies are arranged at equal intervals.

[0008] In some possible embodiments, the electrode assembly comprises an outer electrode, an insulation layer, and at least two inner electrodes, the inner electrodes are arranged on the inner side of the insulation layer, the outer electrode is sleeved on the outer side of the insulation layer, and the discharge gap between each inner electrode and the outer electrode is consistent.

[0009] In some possible embodiments, the axial length B of the insulation layer is obtained based on the following formula: B=A+M*N*K1*K2*L1, wherein A is the axial length of the inner electrode of the electrode assembly, the unit of A is mm, M is the number of inner electrodes contained in one electrode assembly, N is the number of electrode assemblies contained in one shock wave generating channel, K1 is a discharge coefficient, the range of K1 is 4-8KV / mm, K2 is an insulation coefficient, the range of K2 is 0.5-0.8mm / KV, and L1 is the discharge gap distance between the inner electrode and the outer electrode in the electrode assembly, the range of L1 is 0.05-0.1mm; the axial length difference between the insulation layer and the inner electrode ranges from MN*0.1mm to MN*0.64mm.

[0010] In some possible embodiments, a protective sleeve is arranged between adjacent electrode assemblies, two ends of the protective sleeve are connected to the outer electrode edges of adjacent electrode assemblies respectively, and the protective sleeve is used for wrapping the series connection line between adjacent electrode assemblies; the axial length C of the protective sleeve is obtained based on the following formula: C=D-Y, wherein D is the axial spacing of adjacent electrode assemblies, and Y is the axial length of the connecting piece between the protective sleeve and the electrode assembly.

[0011] In some possible embodiments, at least two first through holes are formed in the outer electrode, the first through holes correspond to the inner electrodes one by one, each first through hole is aligned with the corresponding inner electrode, at least two second through holes are formed in the insulation layer, the second through holes correspond to the first through holes one by one, and the discharge gap is formed between the first through holes and the inner electrodes.

[0012] In some possible embodiments, the inner electrode protrudes axially from the insulation layer, and the protruding end of the inner electrode forms a discharge gap with the end of the adjacent outer electrode.

[0013] In some possible embodiments, the electrode assembly comprises at least one group of first electrode assemblies and at least one group of second electrode assemblies, the at least one group of first electrode assemblies and the at least one group of second electrode assemblies are arranged at intervals in the axial direction, and the second electrode assemblies are located at the distal end of the catheter relative to the first electrode assemblies.

[0014] In some possible embodiments, the first electrode assembly comprises a first outer electrode, a first insulating layer, and at least two first inner electrodes arranged in an interval, the first inner electrodes and the first outer electrode are isolated by the first insulating layer, and the first inner electrodes and the first outer electrode have a first discharge gap therebetween;

[0015] The second electrode assembly comprises a second outer electrode, a second insulating layer, and at least two second inner electrodes arranged in an interval, the second inner electrodes and the second outer electrode are isolated by the second insulating layer, and the second inner electrodes and the second outer electrode have a second discharge gap therebetween.

[0016] In some possible embodiments, the first inner electrodes of the at least two groups of first electrode assemblies are arranged in an interval in a circumferential direction of the catheter.

[0017] In some possible embodiments, the shock wave emitting device comprises at least two groups of first electrode assemblies, and the first inner electrodes of the at least two groups of first electrode assemblies are arranged in an interval in a circumferential direction of the catheter.

[0018] In some possible embodiments, one end of the second insulating layer close to a distal end protrudes an end surface of the second outer electrode in an axial direction, and one end of the second inner electrode close to the distal end protrudes an end surface of the second insulating layer to generate a shock wave acting force released towards the distal end, and the at least two second inner electrodes protrude the same end surface of the second insulating layer.

[0019] In some possible embodiments, a shortest interval between two adjacent second inner electrodes in a circumferential direction of the catheter is greater than a gap length of the second discharge gap, and the gap length of the second discharge gap is a minimum distance of a discharge path between the second inner electrodes and the second outer electrode.

[0020] In some possible embodiments, the first inner electrodes of the first electrode assembly are connected to a first electrode wire, and one end of the first electrode wire is connected to the first inner electrodes which do not protrude the first insulating layer; and the second inner electrodes of the second electrode assembly are connected to a second electrode wire, and one end of the second electrode wire is connected to the first inner electrodes which do not protrude the first insulating layer.

[0021] In some possible embodiments, a forming method of the first electrode assembly comprises:

[0022] at least two first inner electrodes are connected to the catheter, and the at least two first inner electrodes are arranged at intervals from each other;

[0023] a first insulation layer is sleeved outside the at least two first inner electrodes, and one end of the first inner electrode protrudes from an end surface of the first insulation layer along an axial direction of the catheter;

[0024] a first outer electrode is sleeved outside the first insulation layer, so that the first outer electrode, the first insulation layer and the at least two first inner electrodes form a first electrode assembly, the first inner electrode and the first outer electrode are separated by the first insulation layer, at least one end of the first insulation layer protrudes from an end surface of the first outer electrode along the axial direction, and a first discharge gap is formed between the first inner electrode and the first outer electrode.

[0025] According to another embodiment of the present application, there is provided a shock wave system, comprising a pulse generating device and the shock wave emitting device according to any one of the above embodiments, the shock wave emitting device being electrically connected to the pulse generating device, and the pulse generating device being configured to provide a high-voltage pulse signal to the shock wave emitting device.

[0026] In some possible embodiments, a chip assembly is arranged in the connector, and the chip assembly is configured to acquire state parameters of the shock wave emitting device, the state parameters including at least one of the following: a number of released pulses, a powered-on time, a consumable type of the electrode assembly, and a catheter balloon type.

[0027] In some possible embodiments, the pulse generating device comprises a control module, a charging and discharging module, a triggering module and a pulse output module, the control module stores a preset configuration file, the control module is communicatively connected to the chip assembly of the connector, the connector is configured to acquire state parameters of the shock wave emitting device and send the state parameters to the control module, and the control module is further connected to a monitoring module, and the monitoring module is configured to acquire static parameters of the shock wave emitting device.

[0028] In some possible embodiments, the control module is electrically connected to the charging and discharging module and the pulse output module respectively, the control module is configured to send a charging control signal to the charging and discharging module and send a shock wave control signal to the pulse output module, and the control module comprises an energy enhancement circuit, and the energy enhancement circuit is configured to control an energy parameter of the shock wave, so that the energy of the shock wave emitted by the shock wave emitting device changes in multiples.

[0029] In some possible implementation manners, the charging and discharging module comprises a pulse width modulation charging circuit and an energy storage capacitor, a power input end of the pulse width modulation charging circuit is connected with a charging power supply, a control input end of the pulse width modulation charging circuit is configured to receive the charging control signal, and an output end of the pulse width modulation charging circuit is electrically connected with the energy storage capacitor, and the output end of the pulse width modulation charging circuit is configured to charge the energy storage capacitor.

[0030] In some possible implementation manners, the trigger module comprises a pulse switch, an input end of the trigger module is electrically connected with the energy storage capacitor, an output end of the trigger module is connected with an input end of the pulse output module, and the trigger module controls the pulse switch to open to release the electric energy of the energy storage capacitor after receiving the trigger signal.

[0031] An output end of the pulse output module is connected with an input end of the shock wave emitting device, and the pulse output module controls the opening and closing of a shock wave generating channel of the shock wave emitting device after receiving the shock wave control signal.

[0032] In some possible implementation manners, the pulse generating device further comprises an isolation device, and the control module, the charging and discharging module, the trigger module, the pulse output module, and each two of the modules are provided with the isolation device, and the isolation device comprises at least one of a signal isolator, an electrical isolator, and a high-voltage isolation circuit.

[0033] In some possible implementation manners, the shock wave system further comprises a connector connected with the pulse generating device and the shock wave emitting device respectively, a chip assembly is arranged in the connector, the chip assembly is configured to acquire a state parameter of the shock wave emitting device connected with the connector, the state parameter comprises at least one of a number of released pulses, a powered-on time, a type of consumables of an electrode assembly, and a type of a catheter balloon, and the chip assembly is in communication connection with the control module, and the chip assembly is configured to send the state parameter to the control module.

[0034] In some possible implementation manners, the shock wave system adopts the following control method:

[0035] In a case where the shock wave emitting device is connected to the pulse generating device, a static parameter of the shock wave emitting device is acquired, and the static parameter of the shock wave emitting device comprises at least one of a number of shock wave generating channels, a number of electrode assemblies in the shock wave generating channels, and a structure of the electrode assemblies in the shock wave generating channels.

[0036] Configure working parameters of the pulse generating device based on the preset configuration file and the obtained static parameters, and control the pulse generating device to send a pulse signal to the shock wave emitting device;

[0037] In a case where the shock wave emitting device releases a shock wave, obtain a state parameter of the shock wave emitting device, the state parameter of the shock wave emitting device including at least one of the following: a number of released pulses, a powered-on time, and a consumable model of the electrode assembly.

[0038] Obtain a preset state comparison condition based on the preset configuration file, and in a case where the obtained state parameter meets the preset state comparison condition, control the pulse generating device to stop sending a pulse signal to the shock wave emitting device.

[0039] The present application has the following advantages:

[0040] 1. In the electrode device, the first electrode assembly protrudes at least one end of the first insulating layer in the axial direction beyond the end surface of the first outer electrode, and one end of the first inner electrode protrudes in the axial direction beyond the end surface of the first insulating layer, so that the first discharge gap is formed at one end of the first electrode assembly in the axial direction. This can significantly increase the distance between the position for connecting the first electrode assembly to the first electrode wire and the first discharge gap, reduce the damage to the connection between the first electrode assembly and the first electrode wire caused by the shock wave force generated at the first discharge gap during use, greatly reduce the risk of fracture failure of the first electrode wire at the connection, and greatly extend the service life of the electrode device. At the same time, it is beneficial to improve the release stability of the shock wave force and improve the effectiveness and safety of use of the electrode device and the shock wave system.

[0041] 2. In the electrode device, at least one second electrode assembly is provided on the catheter, the second inner electrode is arranged to protrude in the axial direction beyond the second insulating layer, and the second insulating layer is arranged to protrude in the axial direction beyond the second outer electrode, forming a stepped protruding structure in the axial direction. When the second inner electrode and the second outer electrode are conductive, the shock wave force is concentrated and released in the axial direction, which can expand the severe calcification area at the distal end of the electrode device simply and efficiently, and is beneficial to improve the passability of the electrode device and the remaining components at the proximal end thereof, facilitate the deepening of the electrode device into the treatment area, and improve the effectiveness, accuracy and stability of the electrode device in releasing the shock wave force to the treatment area.

[0042] 3、The second electrode assembly of the electrode device can release the shock wave action force forward at a position closer to the distal end, further reducing the distance between the shock wave action force and the calcified serious area in the tissue, reducing the loss of the shock wave action force in the transmission process, improving the shock wave intensity acting on the calcified serious tissue, and being beneficial to improving the expansion efficiency and expansion effect.

[0043] 4、The at least two shock wave generation channels of the shock wave emitting device share one electrode line, and the electrode assemblies in each shock wave generation channel are connected in series, which can reduce the occupancy rate of the electric wire to the balloon cavity space, make the balloon have a larger liquid flow area, facilitate the pressure charging and pressure releasing process of the balloon, and further improve the treatment effect of the shock wave system.

[0044] 5、The shock wave generation channel comprises five or more electrode assemblies connected in series, so that the shock wave emitted by the shock wave emitting device has a wider coverage in the length direction of the balloon, and the intensity of the emitted shock wave is balanced along the length direction of the balloon.

[0045] 6、The protective sleeve is arranged between adjacent electrode assemblies, and the two ends of the protective sleeve are connected to the outer electrode edges of the adjacent electrode assemblies, so that the burning damage of the outer electrode during discharge of the electrode assembly can be improved, the protective sleeve can limit and fix the series connection line between the electrode assemblies, the insulation strength of the series connection line can be enhanced, the series connection line can be prevented from being vibrated and displaced by mechanical impact force, and the service life of the shock wave emitting device can be prolonged.

[0046] 7、The pulse generation device adopts a pulse width modulation charging circuit, can realize output of 1KV-20KV voltage within milliseconds, and can realize adjustable output voltage and adjustable shock wave pulse release frequency within 1-30Hz through adjustment of the control signal by the control module.

[0047] 8、The shock wave system can adjust the pulse signal of the pulse generation device in real time according to the static parameters and state parameters of the shock wave emitting device connected to the pulse generation device, so as to achieve the effect of intelligent identification and regulation of shock wave release.

[0048] It should be understood that the above general description and the following detailed description are only exemplary and explanatory, but not limiting the present application.

[0049] Other features and aspects of the present application will become apparent from the following detailed description of exemplary embodiments, taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF DRAWINGS

[0050] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, and the advantages thereof, the following will briefly introduce the drawings needed in the embodiments or prior art description. Obviously, the drawings in the following description are only some embodiments of the present application, and for those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0051] Fig. 1 is a perspective structural schematic view of an electrode device according to an embodiment of the present application;

[0052] Fig. 2 is an assembly structural schematic view of an electrode device according to an embodiment of the present application;

[0053] Fig. 3 is an assembly structural schematic view of a first electrode assembly according to an embodiment of the present application;

[0054] Fig. 4 is an exploded view of a first electrode assembly according to an embodiment of the present application;

[0055] Fig. 5 is an exploded view of a second electrode assembly according to an embodiment of the present application;

[0056] Fig. 6 is a connection structural schematic view of a first electrode wire and a second electrode wire according to an embodiment of the present application;

[0057] Fig. 7 is a structural schematic view of a shock wave system including an electrode device according to an embodiment of the present application;

[0058] Fig. 8 is an electrical connection framework view of an electrode device in an exemplary embodiment of the present application;

[0059] Fig. 9 is a structural schematic view of a shock wave system including an electrode device according to another embodiment of the present application;

[0060] Fig. 10 is an electrical connection framework view of an electrode device in another exemplary embodiment of the present application;

[0061] Fig. 11 is a perspective structural schematic view of an electrode device in Example 4;

[0062] Fig. 12 is a test result schematic view of the maximum pulse discharge times of an electrode device in Example 4;

[0063] Fig. 13 is a detection schematic view of the shock wave peak pressure at a distance of 3 mm from an electrode device within the service life of the electrode device in Example 4;

[0064] Fig. 14 is a physical appearance view of an electrode device after the service life of the electrode device in Example 4 is exhausted;

[0065] Fig. 15 is a physical appearance view of an electrode device in the prior art after the service life of the electrode device is exhausted.

[0066] Figure 16 shows a structural schematic diagram of a shock wave emitting device according to an embodiment of the present application;

[0067] Figure 17 shows a shock wave release intensity diagram of three parallelly connected electrode assemblies in the related art;

[0068] Figure 18 shows a shock wave intensity diagram of a shock wave generating channel containing five electrode assemblies according to an embodiment of the present application;

[0069] Figure 19 shows a shock wave intensity diagram of a shock wave generating channel containing five electrode assemblies released under a higher voltage pulse signal driving according to an embodiment of the present application;

[0070] Figure 20 shows a wiring diagram of two shock wave generating channels sharing one electrode line according to an embodiment of the present application;

[0071] Figure 21 shows a series wiring diagram of electrode assemblies according to an embodiment of the present application;

[0072] Figure 22 shows a structural schematic diagram of a center aperture discharge electrode assembly according to an embodiment of the present application;

[0073] Figure 23 shows a structural schematic diagram of a two-end discharge electrode assembly according to an embodiment of the present application;

[0074] Figure 24 shows a structural schematic diagram of different electrode assemblies with the inner electrodes of the electrode assemblies disposed in a circumferential staggered manner according to an embodiment of the present application;

[0075] Figure 25 shows a curve diagram of the minimum applied voltage and discharge gap of a single electrode assembly according to an embodiment of the present application;

[0076] Figure 26 shows an installation position schematic diagram of a protective sleeve of a shock wave emitting device according to an embodiment of the present application;

[0077] Figure 27 shows a structural block diagram of a shock wave system containing a shock wave emitting device according to an embodiment of the present application;

[0078] Figure 28 shows a control method flowchart one of a shock wave system according to an embodiment of the present application;

[0079] Figure 29 shows a control method flowchart two of a shock wave system according to an embodiment of the present application.

[0080] In the drawings:

[0081] 1-catheter, 2-first electrode assembly, 21-first outer electrode, 22-first insulation layer, 23-first inner electrode, 3-second electrode assembly, 31-second outer electrode, 32-second insulation layer, 33-second inner electrode, 4-first electrode wire, 5-second electrode wire, 6-balloon; 100-catheter; 200-balloon; 300-electrode assembly; 301-outer electrode; 3011-first through hole; 302-insulation layer; 3021-second through hole; 303-inner electrode; 400-protective sleeve; 500-control module; 600-charge and discharge module; 700-trigger module; 800-pulse output module; 900-connector. DETAILED DESCRIPTION

[0082] The technical solutions in the embodiments of the present specification will be described clearly and completely below in combination with the drawings in the embodiments of the present specification. Obviously, the described embodiments are only part of the embodiments of the present specification, rather than all the embodiments. Based on the embodiments in the present specification, all other embodiments obtained by those skilled in the art without creative work belong to the protection scope of the present specification.

[0083] It should be noted that the terms "first", "second", and the like in the specification and claims of the present specification and the above-described drawings are used to distinguish similar objects, and do not necessarily have to be used to describe a specific order or sequence. It should be understood that the data used in this way can be interchanged under appropriate circumstances, so that the embodiments of the present specification described herein can be implemented in an order other than those illustrated or described herein. In addition, the terms "include" and "have" and any variations thereof are intended to cover non-exclusive inclusion, for example, a process, method, system, product or server including a series of steps or units does not have to be limited to those steps or units clearly listed, but can include other steps or units not clearly listed or inherent to these processes, methods, products or devices.

[0084] Various exemplary embodiments, features and aspects of the present specification will be described in detail below with reference to the accompanying drawings. The same reference numerals in the drawings represent functionally the same or similar elements. Although various aspects of the embodiments are shown in the drawings, the drawings are not necessarily drawn to scale unless specifically indicated.

[0085] The word "exemplary" is used herein in the sense of being an example, instance, or illustration. Any embodiment described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments.

[0086] The term “and / or”, as used herein, merely describes association between associated objects, and can indicate that three types of relationships can exist, for example, A and / or B can mean that A exists alone, A and B exist together, and B exists alone. In addition, the term “at least one of’ herein means any one of or a combination of at least two of a plurality, for example, at least one of A, B, and C can mean any one or more elements selected from the set consisting of A, B, and C.

[0087] It should be noted that when an element is considered to be “connected” to another element, it can be directly connected to the other element or connected to the other element through a central element. In the following embodiments, “connected” should be understood as “electrically connected”, “communicatively connected” and the like if the circuits, modules, units and the like connected to each other have transmission of electrical signals or data.

[0088] In addition, in order to better illustrate the present application, numerous specific details are given in the specific embodiments below. Those skilled in the art should understand that the present application can also be implemented without some specific details. In some examples, methods, means, elements and circuits well known to those skilled in the art are not described in detail, in order to highlight the main idea of the present application.

[0089] The shock wave balloon technology is a new, safe and effective technology for treating heart valves and vascular calcification. In related technologies, the electrode assembly structure in the shock wave system has many defects, and the wiring assembly such as the lead wire for conducting the circuit itself is poor in mechanical impact resistance, thereby restricting the service life of the electrode device. The instantaneous high impact pressure and high temperature generated in the moment of shock wave release can damage the weak part of the lead wire, which is usually the connecting position of the lead wire and the electrode. In the process of continuous discharge, the damage to the weak part accumulates until the lead wire breaks down, resulting in the electrode assembly being unable to discharge, i.e. the service life is exhausted. For example, some electrode assemblies have holes on the electrodes, resulting in multiple structural weak points on the electrodes, which are difficult to withstand high working voltage and are easily broken down, affecting the service life. In addition, in order to ensure the symmetry of the discharge point, the discharge point (or discharge gap) is usually placed at the central position of the electrode assembly, so that the distance between the discharge point and the weak part of the lead wire is usually less than half the length of the electrode assembly. The weak part of the lead wire is too close to the discharge point and will bear most of the mechanical impact force and heat brought by the shock wave, and the service life of the electrode assembly is sharply reduced.

[0090] In addition, the balloon diameter of some shock wave systems is larger than the catheter diameter, and in the calcified area, especially in the calcified area of coronary and peripheral vessels, the space available for the balloon to pass between the calcified tissues is limited, making it difficult for the distal end of the conventional balloon to pass through, and even forming an occluded section. It is very difficult for the conventional balloon to expand, resulting in the catheter passing through but the balloon being difficult to pass through, and failing to reach the treatment area for treatment, greatly limiting the passability of the balloon and the treatment effect of the shock wave system.

[0091] To solve at least one of the above problems faced by the shock wave system, the present application provides an electrode device, wherein, as shown in Figures 1 and 2, the electrode device is arranged on the catheter 1 of the shock wave system, and the electrode device is located inside the balloon 6 of the shock wave system, and the electrode device comprises at least one first electrode assembly 2, which is mainly used to release the shock wave action force towards the treatment area after reaching the treatment area, so as to soften the calcified tissue of the treatment area and achieve precise treatment.

[0092] Specifically, as shown in Figures 3 and 4, the first electrode assembly 2 comprises a first outer electrode 21, a first insulating layer 22 and at least two first inner electrodes 23 arranged at intervals, the first inner electrodes 23 and the first outer electrode 21 are isolated by the first insulating layer 22; at least one end of the first insulating layer 22 protrudes from the end face of the first outer electrode 21, and one end of the first inner electrode 23 protrudes from the end face of the first insulating layer 22, and the first inner electrode 23 and the first outer electrode 21 have a first discharge gap therebetween; in this way, the first electrode assembly 2 is connected with the power supply through the first electrode wire 4 to realize conduction, the first discharge gap is located at one end of the first electrode assembly 2, allowing the first electrode wire 4 to be connected to the other end of the first electrode assembly 2 away from the first discharge gap, i.e. significantly increasing the distance between the position of the first electrode assembly 2 for connecting with the first electrode wire 4 and the first discharge gap, reducing the damage to the connection between the first electrode assembly 2 and the first electrode wire 4 caused by the shock wave action force generated at the first discharge gap during use, especially reducing the damage to the first electrode wire 4, greatly reducing the risk of breakage of the first electrode wire 4 at the connection, greatly prolonging the service life of the electrode device, and at the same time, being conducive to improving the release stability of the shock wave action force, improving the effectiveness and safety of use of the electrode device and the shock wave system.

[0093] Specifically, as shown in FIGS. 1-2, the first insulating layer 22 is wrapped on the conduit 1, the first inner electrode 23 is embedded between the conduit 1 and the first insulating layer 22, and the first outer electrode 21 is sleeved on the outer wall of the first insulating layer 22, so that the first insulating layer 22 effectively isolates the first outer electrode 21 and the first inner electrode 23; in some exemplary embodiments, the first insulating layer 22 is in interference fit with the first inner electrode 23, so as to improve the limiting effect of the first insulating layer 22 on the first inner electrode 23 while effectively isolating the first outer electrode 21 and the first inner electrode 23, prevent the first inner electrode 23 from abnormally shifting during work, and be beneficial to improving the output stability of the shock wave system and prolonging the service life of the first electrode assembly 2 and the electrode device.

[0094] Specifically, as shown in FIG. 2, in some exemplary embodiments, one end of the first insulating layer 22 protrudes axially from the end face of the first outer electrode 21, and the other end is flush with the end face of the first outer electrode 21, which can save the material of the first insulating layer 22, reduce the cost, and when assembling, only the lengths of the first insulating layer 22 and the first outer electrode 21 need to be determined, and then the two ends can be aligned and assembled, thereby improving the assembly convenience; in other exemplary embodiments, both ends of the first insulating layer 22 protrude axially from the end faces of the two ends of the first outer electrode 21, so as to avoid the undesired situation that the first outer electrode 21 protrudes axially from the first insulating layer 22 and causes conduction short circuit between the first inner electrode 23 and the first outer electrode 21 in the area outside the first discharge gap due to slight shift during work, which can greatly reduce the damage that the electrode device may suffer during use, and improve the working stability, reliability and durability of the first electrode assembly 2 and the electrode device.

[0095] Specifically, in some exemplary embodiments, the axial length of the protruding end of the first insulating layer 22 protruding from the first outer electrode 21 is 0mm-0.5mm; it can be understood that the axial length of the protruding end of the first insulating layer 22 protruding from the first outer electrode 21 can be any point value in the range of 0mm-0.5mm; for example, the axial length of the protruding end of the first insulating layer 22 protruding from the first outer electrode 21 can be 0mm, 0.1mm, 0.2mm, 0.25mm, 0.3mm, 0.4mm, 0.5mm, etc.; in this way, the short circuit during work can be effectively avoided, and the working stability, reliability and durability of the first electrode assembly 2 and the electrode device can be greatly improved; in some preferred embodiments, the axial length of the protruding end of the first insulating layer 22 protruding from the first outer electrode 21 is greater than 0mm and less than 0.5mm.

[0096] Specifically, in some exemplary embodiments, in the same first electrode assembly 2, the two adjacent first inner electrodes 23 are arranged in the circumferential direction of the catheter 1, and the shortest distance between the two adjacent first inner electrodes 23 in the circumferential direction corresponds to a central angle of 30°-90°. Understandably, the shortest distance between the two adjacent first inner electrodes 23 in the circumferential direction corresponds to a central angle of any point value in 30°-90°. For example, the shortest distance between the two adjacent first inner electrodes 23 in the circumferential direction corresponds to a central angle of 30°, 45°, 50°, 55°, 60°, 75°, 80°, 90°, etc. In this way, the distance between the two first inner electrodes 23 can be increased to ensure that the two first inner electrodes 23 cannot be contacted, and the discharge effectiveness and accuracy of the first electrode assembly 2 can be improved, and the reliability and safety are good.

[0097] Specifically, in some exemplary embodiments, the axial length of the first inner electrode 23 is 1.0-2.0 mm. Understandably, the axial length of the first inner electrode 23 can be any point value in 1.0-2.0 mm. In some exemplary embodiments, the length of the protruding section of the first inner electrode 23 protruding out of the first insulating layer 22 in the axial direction is greater than 0.2 mm and less than 0.25 times the axial length of the first inner electrode 23. For example, the axial length of the first inner electrode 23 is 2.0 mm, and the length of the protruding section of the first inner electrode 23 protruding out of the first insulating layer 22 in the axial direction is greater than 0.2 mm and less than 0.5 mm. In this way, the discharge effectiveness and reliability can be improved, and the service life of the first electrode assembly 2 can be prolonged.

[0098] Specifically, as shown in FIG. 2, the electrode device further comprises a first electrode wire 4, and the first electrode assembly 2 is electrically connected to the power supply through the first electrode wire 4. The first electrode wire 4 is electrically connected to at least one of the at least two first inner electrodes 23 to conduct the first electrode assembly 2. Moreover, one end of the first inner electrode 23 located in the first insulating layer 22 is electrically connected to the first electrode wire 4, i.e., one end of the first inner electrode 23 away from the first discharge gap is electrically connected to the first electrode wire 4, which increases the distance from the first discharge gap to the connection of the first electrode wire 4, reduces the damage of the shock wave force to the connection of the first electrode wire 4, and is conducive to prolonging the service life of the first electrode wire 4, the first electrode assembly 2, and the electrode device as a whole, and is also conducive to improving the discharge stability of the first electrode assembly 2 and the electrode device.

[0099] Specifically, as shown in FIG. 4, in some exemplary embodiments, the first electrode assembly 2 includes at least two first inner electrodes 23 arranged at intervals, among which part of the first inner electrodes 23 protrude from the proximal end face of the first insulation layer 22, and the rest of the first inner electrodes 23 protrude from the distal end face of the first insulation layer 22, i.e., respectively forming a first discharge gap at both ends of the first electrode assembly 2, which is conducive to dispersing multi-point positioning treatment on multiple areas to be treated, improving the axial treatment area of the electrode device, and the asymmetric discharge structure is conducive to dispersing the damage to the connection of the first electrode wire 4 caused by the impact wave force, thereby prolonging the service life of the electrode device.

[0100] Specifically, the first electrode wire 4 is electrically connected with the at least two first inner electrodes 23 of the first electrode assembly 2, and the connection between the first electrode wire 4 and the first inner electrodes 23 is located inside the first insulation layer 22, which can play a certain protective role for the first electrode wire 4, and as shown in FIG. 3, the connection between the first inner electrode 23 and the first electrode wire 4 is located at one end of the first inner electrode 23, which is away from the end of the first inner electrode 23 used to form the first discharge gap, which can significantly increase the distance A between the first discharge gap and the connection of the first electrode wire 4. The shock wave decays severely in a short distance, and a small distance difference can produce a large shock wave difference, thereby greatly reducing the damage to the connection of the first electrode wire 4 caused by the impact wave force during use, reducing the risk of breakage of the first electrode wire 4, and greatly prolonging the service life of the first electrode wire 4; when a voltage is applied, the at least two first inner electrodes 23 are connected with the power supply through the first electrode wire 4, the current passes through one first inner electrode 23, breaks through the liquid medium at one first discharge gap, and then the working current is introduced into the first outer electrode 21, and then breaks through the liquid medium at another first discharge gap, and the working current is introduced into another first inner electrode 23, thereby realizing the conduction discharge of the first electrode assembly 2, and effectively treating the area to be treated.

[0101] Specifically, the at least two first inner electrodes 23 are arranged at intervals in the circumferential direction of the catheter 1, i.e., the shortest distance between the two adjacent first inner electrodes 23 in the circumferential direction is greater than the gap length of the first discharge gap, so as to prevent abnormal breakdown in the non-discharge area between the first inner electrodes 23; and the first insulation layer 22 is in interference fit with the first inner electrodes 23, and the circumferential area between the two adjacent first inner electrodes 23 is tightly attached to the inner catheter 1, which can also isolate the two adjacent first inner electrodes 23 to a certain extent, prevent abnormal breakdown, improve the discharge reliability of the first electrode assembly 2, and improve the safety of the treatment process.

[0102] The gap length of the first discharge gap is the minimum straight-line distance between the first inner electrode 23 and the first outer electrode 21, and the discharge path thereof passes through the end surface of the first insulating layer 22, so that the liquid medium at the first discharge gap can be effectively broken down when the voltage is turned on, and the liquid medium in other non-discharge areas is not easily broken down, ensuring the accuracy and reliability of the discharge position and improving the treatment effect.

[0103] In some exemplary embodiments, the electrode device comprises one first electrode assembly 2; in other exemplary embodiments, the electrode device comprises at least two first electrode assemblies 2; in this way, the first electrode assembly 2 is arranged flexibly and can be applied to various treatment scenarios and treatment needs.

[0104] In some exemplary embodiments, in the case where the electrode device comprises at least two first electrode assemblies 2, the two adjacent first electrode assemblies 2 are insulated from each other in the axial direction, that is, the axial minimum distance between at least one of the first outer electrode 21 and the first inner electrode 23 of one first electrode assembly 2 and at least one of the first outer electrode 21 and the first inner electrode 23 of the adjacent first electrode assembly 2 is greater than the gap length of the first discharge gap, so as to avoid abnormal breakdown phenomenon in the non-discharge area outside the first discharge gap, which can not only improve the accuracy of the formation of the shock wave force, but also reduce the risk of abnormal damage of the first electrode assembly 2.

[0105] Specifically, as shown in FIG. 2, in some exemplary embodiments, in the case where the electrode device comprises at least two first electrode assemblies 2, the first inner electrodes 23 of the at least two groups of first electrode assemblies 2 are arranged in a circumferential direction of the catheter 1; further, the first inner electrodes 23 of the two adjacent groups of first electrode assemblies 2 are arranged in a circumferential direction; during assembly, the first inner electrodes 23 can be rotated to quickly adjust the orientation of the two adjacent first electrode assemblies 2, so as to adjust the relative position of the first discharge gap in the two adjacent first electrode assemblies 2, so that the first discharge gap in the two adjacent first electrode assemblies 2 is also arranged in a circumferential direction, so as to perform multi-point and multi-direction discharge, which is convenient for treating intravascular calcification; for example, the included angle formed by the two adjacent groups of first electrode assemblies 2 around the central axis of the catheter 1 is 90°.

[0106] Specifically, as shown in FIG. 1 and FIG. 5, the electrode device comprises at least one second electrode assembly 3, which is arranged axially spaced apart from the at least one first electrode assembly 2, i.e. the first electrode assembly 2 and the second electrode assembly 3 are axially insulated from each other to avoid abnormal discharge mutual interference; in addition, it should be noted that the second electrode assembly 3 is located at the distal end of the catheter 1 relative to the first electrode assembly 2, i.e. the second electrode assembly 3 is located at the head of the balloon 6, so as to provide more concentrated axial shock wave force for expansion, facilitating the balloon 6 to effectively open the calcified treatment area.

[0107] The second electrode assembly 3 comprises a second outer electrode 31, a second insulating layer 32 and at least two second inner electrodes 33 arranged spaced apart, the second inner electrodes 33 and the second outer electrode 31 are insulated by the second insulating layer 32, so that the second inner electrodes 33 and the second outer electrode 31 are relatively insulated; and at least one end of the second insulating layer 32 protrudes from the end face of the second outer electrode 31 along the axial direction of the catheter 1, and one end of the second inner electrode 33 protrudes from the end face of the second insulating layer 32 along the axial direction, so that the second inner electrode 33 and the second outer electrode 31 have a second discharge gap, which is the minimum interval between the part of the second inner electrode 33 protruding from the second insulating layer 32 and the end face of the second outer electrode 31; i.e. in some embodiments, the shape of the first electrode assembly 2 is the same as that of the second electrode assembly 3; the second discharge gap in the second electrode assembly 3 is also located at one end of the second electrode assembly 3 in the axial direction, which can significantly increase the distance from the connection of the second electrode wire 5 for conducting the second electrode assembly 3 to the second discharge gap, thereby reducing the risk of fracture failure of the second electrode wire 5 at the connection, greatly prolonging the service life of the electrode device, and at the same time, facilitating to improve the release stability of the shock wave force.

[0108] When a voltage is applied to the second electrode assembly 3, the second electrode assembly 3 is in a liquid medium in the balloon 6, and the voltage can break through the liquid medium in the second discharge gap, so that the second inner electrode 33 is conducted with the second outer electrode 31 through the part of the second inner electrode 33 protruding from the second insulating layer 32, generating a shock wave force released at least partially along the axial direction of the catheter 1, helping the distal end (or head) of the balloon 6 to expand the calcified area, so as to facilitate the balloon 6 as a whole to accurately reach the treatment area through the calcified area, greatly improving the passability of the balloon 6 and the shock wave system, and thereby facilitating to improve the accuracy and effectiveness of treating the calcification of the treatment area.

[0109] Specifically, as shown in FIG. 1, the second insulation layer 32 is wrapped on the conduit 1, as shown in FIG. 2, the second inner electrode 33 is embedded between the conduit 1 and the second insulation layer 32, and the second outer electrode 31 is sleeved on the outer wall of the second insulation layer 32, so that the second insulation layer 32 effectively isolates the second outer electrode 31 and the second inner electrode 33; in some exemplary embodiments, the second insulation layer 32 and the second inner electrode 33 are interference fit, so as to improve the limiting effect of the second insulation layer 32 on the second inner electrode 33 while effectively isolating the second outer electrode 31 and the second inner electrode 33, preventing the second inner electrode 33 from abnormally moving during work, which is conducive to improving the output stability of the shock wave system and prolonging the service life of the second electrode assembly 3 and the electrode device.

[0110] In some exemplary embodiments, the materials of the first insulation layer 22 and the second insulation layer 32 are flexible materials with high insulation; further, the materials of the first insulation layer 22 and the second insulation layer 32 are heat-shrinkable materials with high insulation, such as polyethylene (PE); the flexible material has good elasticity, which is convenient for sleeving and assembling on one hand, and has good fastening, wrapping and filling effects on the other hand, can effectively prevent the first inner electrode 23 and the second inner electrode 33 from moving in the axial, circumferential and radial directions of the conduit 1, effectively maintain the structural stability and deformation resistance of the second electrode assembly 3, the first electrode assembly 2 and the entire electrode device, and can also prevent abnormal discharge in the non-discharge area, thereby improving the durability and long-term effectiveness of the electrode device.

[0111] Specifically, in some exemplary embodiments, one end of the second insulation layer 32 protrudes axially beyond the end face of the second outer electrode 31, and the other end is flush with the end face of the second outer electrode 31, which can save the material of the second insulation layer 32, reduce the cost, and when assembling, only the lengths of the second insulation layer 32 and the second outer electrode 31 need to be determined, and then the two ends can be aligned and assembled, which greatly improves the assembly convenience; in other exemplary embodiments, both ends of the second insulation layer 32 protrude axially beyond the end faces of both ends of the second outer electrode 31, so as to avoid the undesired situation that the second outer electrode 31 protrudes axially beyond the second insulation layer 32 and is in conduction with the second inner electrode 33 in the area outside the second discharge gap due to slight movement during work, which can greatly reduce the damage that the electrode device may suffer during use, and improve the working stability, reliability and durability of the second electrode assembly 3 and the electrode device.

[0112] Specifically, in some exemplary embodiments, the axial length of the second insulating layer 32 protruding from the protruding end of the second outer electrode 31 is 0mm-0.5mm; it can be understood that the axial length of the second insulating layer 32 protruding from the protruding end of the second outer electrode 31 can be any point value in 0mm-0.5mm; for example, the axial length of the second insulating layer 32 protruding from the protruding end of the second outer electrode 31 can be 0mm, 0.1mm, 0.2mm, 0.25mm, 0.3mm, 0.4mm, 0.5mm, etc.; in this way, the short circuit during operation can be effectively avoided, and the working stability, reliability and durability of the second electrode assembly 3 and the electrode device can be greatly improved; in some preferred embodiments, the axial length of the second insulating layer 32 protruding from the protruding end of the second outer electrode 31 is greater than 0mm and less than 0.5mm.

[0113] Specifically, in some exemplary embodiments, the axial length of the second inner electrode 33 is 1.0mm-2.0mm; it can be understood that the axial length of the second inner electrode 33 can be any point value in 1.0mm-2.0mm; in some exemplary embodiments, the length of the protruding section of the second inner electrode 33 protruding from the second insulating layer 32 in the axial direction is greater than 0.2mm and less than 0.25 times the axial length of the second inner electrode 33; for example, the axial length of the second inner electrode 33 is 2.0mm, and the length of the protruding section of the second inner electrode 33 protruding from the second insulating layer 32 in the axial direction is greater than 0.2mm and less than 0.5mm; in this way, the discharge effectiveness and discharge reliability can be improved, and the service life of the second electrode assembly 3 can be prolonged.

[0114] Specifically, in some exemplary embodiments, one end of the second insulating layer 32 close to the proximal end protrudes from the end face of the second outer electrode 31 in the axial direction, and one end of the second inner electrode 33 close to the proximal end protrudes from the end face of the second insulating layer 32 in the axial direction, so as to generate an axial shock wave acting force at one end close to the proximal end in the second electrode assembly 3; since the second electrode assembly 3 is located at the front end of the balloon 6, and the size of the second electrode assembly 3 itself is also small, even if the axial shock wave acting force is generated at the proximal end of the second electrode assembly 3, it is generated at the distal end of the balloon 6, i.e. it can be used to expand the calcified area blocking the front end of the balloon 6.

[0115] Specifically, in some preferred embodiments, the second insulation layer 32 protrudes the end surface of the second outer electrode 31 at the end close to the distal end in the axial direction, and the second inner electrode 33 protrudes the end surface of the second insulation layer 32 at the end close to the distal end, so as to generate the shock wave acting force released towards the distal end. Therefore, at the front end of the balloon 6, the distance between the shock wave acting force and the region to be expanded can be further reduced, the transmission loss of the shock wave acting force can be reduced, the shock wave acting force reaching the region to be expanded still retains a high strength, which is beneficial to enhance the expansion effectiveness and expansion efficiency, and save the operation time.

[0116] Specifically, as shown in FIG. 2, the electrode device further comprises a second electrode wire 5, the second electrode assembly 3 is electrically connected with the power supply through the second electrode wire 5; the second electrode wire 5 is electrically connected with at least one of the at least two second inner electrodes 33, so as to turn on the second electrode assembly 3; and one end of the second inner electrode 33 located in the second insulation layer 32 is electrically connected with the second electrode wire 5, that is, the end of the second inner electrode 33 away from the second discharge gap is electrically connected with the second electrode wire 5, which increases the distance from the second discharge gap to the connection position of the second electrode wire 5, reduces the damage of the shock wave acting force to the connection position of the second electrode wire 5, is beneficial to prolong the service life of the second electrode wire 5, the second electrode assembly 3 and the electrode device as a whole, and is also beneficial to improve the discharge stability of the second electrode assembly 3 and the electrode device.

[0117] Specifically, as shown in FIG. 5, in some exemplary embodiments, the second electrode assembly 3 comprises at least two second inner electrodes 33 arranged at intervals, and the at least two second inner electrodes 33 all protrude the same end surface of the second insulation layer 32, so as to form the second discharge gap with the at least two second inner electrodes 33 respectively on the same end surface of the second outer electrode 31; and each second inner electrode 33 forms a second discharge gap with the second outer electrode 31 to perform point discharge, which is beneficial to reduce the discharge dispersion of the second electrode assembly 3, so that the generated shock wave acting force is more concentrated and has stronger shock wave acting force in the axial direction to expand the calcified region, and the passability of the shock wave system balloon is improved; in addition, the second insulation layer 32 can fasten and limit the at least two second inner electrodes 33, without further adding a limiting structure, which is beneficial to simplify the structure of the second electrode assembly 3 and improve the assembly convenience.

[0118] Specifically, the second electrode wire 5 is electrically connected with at least two second inner electrodes 33 of the second electrode assembly 3, and the connection between the second electrode wire 5 and the second inner electrode 33 is located inside the second insulating layer 32, which can protect the second electrode wire 5 to a certain extent, and the connection between the second inner electrode 33 and the second electrode wire 5 is located at one end of the second inner electrode 33, which is away from the end of the second inner electrode 33 for forming the second discharge gap, which can significantly increase the distance between the second discharge gap and the connection of the second electrode wire 5, greatly reduce the damage of the shock wave force to the connection of the second electrode wire 5 during use, reduce the risk of fracture failure of the second electrode wire 5, and prolong the service life of the second electrode wire 5; when the voltage is applied, at least two second inner electrodes 33 are connected with the power supply through the second electrode wire 5, the current passes through one second inner electrode 33, breaks through the liquid medium at one second discharge gap, and then leads the working current into the second outer electrode 31, and then breaks through the liquid medium at another second discharge gap, and leads the working current into another second inner electrode 33, to realize the conduction discharge of the second electrode assembly 3, so as to effectively expand the calcified occlusion area at the distal end of the balloon 6, and improve the passability of the shock wave system with the second electrode assembly 3.

[0119] Specifically, the at least two second inner electrodes 33 are arranged at intervals in the circumferential direction of the catheter 1, that is, the shortest distance between the two adjacent second inner electrodes 33 in the circumferential direction is greater than the gap length of the first discharge gap, so as to prevent abnormal breakdown of the non-discharge area between the second inner electrodes 33; and the second insulating layer 32 is in interference fit with the second inner electrode 33, and is tightly attached to the inner catheter 1 in the circumferential area between the two adjacent second inner electrodes 33, which can also isolate the two adjacent second inner electrodes 33 to a certain extent, prevent abnormal breakdown, improve the discharge reliability of the second electrode assembly 3, and also help to generate axial release of the shock wave force between the second inner electrode 33 and the second outer electrode 31, thereby effectively expanding the second electrode assembly 3.

[0120] Wherein, the gap length of the second discharge gap is the minimum straight-line distance between the second inner electrode 33 and the second outer electrode 31, and the discharge path thereof passes through the end face of the second insulating layer 32, so that the liquid medium at the second discharge gap can be effectively broken down when the voltage is turned on, and the liquid medium in other non-discharge areas is not easy to be broken down, thereby ensuring that the formed shock wave force has at least an axial component, improving the discharge accuracy and stability, and effectively expanding; in addition, it should be noted that the shock wave force generated at the second discharge gap is released in multiple directions, not only in the axial direction, but also in the circumferential and radial directions. The second electrode assembly 3 uses the axial component of the shock wave force for concentrated expansion, thereby greatly improving the passability of the balloon 6 with the second electrode assembly 3 in the calcified tissue.

[0121] In some example embodiments, the electrode device comprises one second electrode assembly 3; in other example embodiments, the electrode device comprises at least two second electrode assemblies 3; in this way, the second electrode assembly 3 can be arranged flexibly to adapt to calcified regions with different degrees of blockage and various treatment scenarios.

[0122] In some example embodiments, in the case where the electrode device comprises at least two second electrode assemblies 3, the two adjacent second electrode assemblies 3 are insulated from each other in the axial direction, i.e., the axial minimum distance between at least one of the second outer electrode 31 and the second inner electrode 33 of one second electrode assembly 3 and at least one of the second outer electrode 31 and the second inner electrode 33 of the adjacent second electrode assembly 3 is greater than the gap length of the second discharge gap; further, the axial minimum distance between the second inner electrode 33 (and the second outer electrode 31) and the adjacent first outer electrode 21 or first inner electrode 23 between the second electrode assembly 3 and the first electrode assembly 2 is also greater than the first discharge gap and the second discharge gap, so as to avoid abnormal breakdown phenomenon in the non-discharge region outside the first discharge gap and the second discharge gap, improve the discharge accuracy, and also reduce the risk of abnormal damage to the electrode device.

[0123] In addition, in some optional embodiments, the gap length of the first discharge gap and the second discharge gap can be equal or not equal, and accordingly, the voltage applied to the second electrode assembly 3 and the voltage applied to the first electrode assembly 2 can be equal or not equal to adapt to different application scenarios and requirements.

[0124] Specifically, as shown in FIG. 6, the first electrode line 4 and the second electrode line 5 are isolated from each other, so that the first electrode assembly 2 and the second electrode assembly 3 can be controlled respectively; wherein at least one first electrode assembly 2 forms a first electric circuit through the first electrode line 4, and at least one second electrode assembly 3 forms a second electric circuit through the second electrode line 5, and the first electric circuit and the second electric circuit can be controlled separately, so that the first electrode assembly 2 and the second electrode assembly 3 can work independently without affecting each other, and the control accuracy is improved.

[0125] Specifically, as shown in FIG. 6, the first electrode line 4 at least comprises a first positive electrode line and a first negative electrode line, and the second electrode line 5 at least comprises a second positive electrode line and a second negative electrode line, wherein the first positive electrode line and the second positive electrode line are respectively connected to different positive electrode interfaces of a power supply, and / or the first negative electrode line and the second negative electrode line are respectively connected to different negative electrode interfaces of a power supply, so as to control the first electrode assembly 2 and the second electrode assembly 3 respectively; for example, the first positive electrode line and the second positive electrode line are connected to the same positive electrode interface of a power supply, and the first negative electrode line and the second negative electrode line are respectively connected to different negative electrode interfaces of a power supply.

[0126] In addition, in some exemplary embodiments, the first electrode line 4 and the second electrode line 5 can share the same positive electrode interface or the same negative electrode interface, and the present application does not make specific limitations as long as the electrode device can be turned on.

[0127] Specifically, in some exemplary embodiments, when the electrode device comprises at least two first electrode assemblies 2 arranged axially at intervals, the at least two first electrode assemblies 2 are connected in series and / or in parallel through the first electrode line 4, so as to prolong the circumferential length of the first electrode assembly 2 acting on the region to be treated and expand the treatment range of the electrode device; the first electrode line 4 further comprises a first transition wire, both ends of the first transition wire being electrically connected to adjacent two first electrode assemblies 2, so as to effectively turn on the adjacent two first electrode assemblies 2.

[0128] Specifically, in some exemplary embodiments, when the electrode device comprises at least two second electrode assemblies 3 arranged axially at intervals, the at least two second electrode assemblies 3 are connected in series and / or in parallel through the second electrode line 5, so as to enhance the strength of the shock wave acting force in the axial direction and improve the expansion efficiency and expansion effect; the second electrode line 5 further comprises a second transition wire, both ends of the second transition wire being electrically connected to adjacent two second electrode assemblies 3, so as to effectively turn on the adjacent two second electrode assemblies 3.

[0129] Optionally, the number of the first electrode assemblies 2 can be 1-7, and the number of the second electrode assemblies 3 can be 1-5, and the combination mode is flexible, which can be suitable for various treatment needs and has good applicability; for example, the number of the first electrode assemblies 2 is 3, the corresponding balloon 6 is relatively short, and is suitable for treating coronary calcification with small calcification length; for example, the number of the first electrode assemblies 2 is 4 or 5, the corresponding balloon 6 is relatively long, and is suitable for treating peripheral vascular calcification with long calcification length.

[0130] The present application also provides a shock wave system, and specifically, as shown in FIG. 7, the shock wave system provided by the present application comprises a catheter 1, a balloon 6 and an electrode device as described above, the electrode device is arranged on the outer wall of the catheter 1 and located in the balloon 6; wherein the catheter 1 penetrates the inner wall of the first inner electrode 21 and the inner wall of the second inner electrode 31, the material of the catheter 1 can be an alloy material with shape memory and certain rigidity, for example, nickel-titanium alloy, so that the electrode device and the shock wave system can smoothly reach the region to be treated under the guidance of the catheter 1 and the expansion of the second electrode assembly 3; the balloon 6 is internally provided with a cavity structure, the cavity structure is used for accommodating the electrode device, the catheter 1 and a liquid medium, the liquid medium is a liquid that can be broken down by discharge and generate a shock wave acting force, and is preferably physiological saline, a mixed solution of physiological saline and contrast agent, silicone oil and the like.

[0131] Specifically, as shown in Fig. 9, the length of the catheter 1 is greater than the length of the balloon 6, the distal end of the balloon 6 is sealingly connected with the catheter 1 to avoid leakage of the liquid medium, the inner diameter of the proximal end of the balloon 6 is greater than or equal to the outer diameter of the electrode device, facilitating assembly of the electrode device into the balloon 6, and the first electrode wire 4 and the second electrode wire 5 are led out of the proximal end of the balloon 6 and connected with the power supply.

[0132] When the balloon 6 of the shock wave system is difficult to pass through an occluded region, a voltage is applied to the second electrode assembly 3 through the second electrode wire 5, the voltage passes through a second inner electrode 33, breaks through the liquid medium of a second discharge gap, working current is led into a second outer electrode 31 through the second discharge gap, then the voltage breaks through the liquid medium of another second discharge gap, working current is led into another second inner electrode 33 through the second discharge gap, and finally flows back to the negative pole of the power supply through the second negative electrode wire; in the process, the second electrode assembly 3 generates at least partially distally and axially released shock wave acting force, which can effectively expand the occluded region in front of the balloon 6, facilitating the balloon 6 to pass through to reach the treatment region.

[0133] After reaching the treatment region, a voltage is applied to the first electrode assembly 2 through the first electrode wire 4,

[0134] the voltage passes through a first inner electrode 23, breaks through the liquid medium of a first discharge gap, working current is led into a first outer electrode 21 through the first discharge gap, then the voltage breaks through the liquid medium of another first discharge gap, working current is led into another first inner electrode 23 through the first discharge gap, and finally flows back to the negative pole of the power supply through the first negative electrode wire, so that the first electrode assembly 2 is turned on to generate shock wave acting force for treating the treatment region; after the treatment is completed, the balloon catheter is depressurized and withdrawn, and the treatment process is completed.

[0135] The embodiment of the application also provides a forming method of the electrode device, comprising:

[0136] S001, connecting at least two first inner electrodes to the catheter; the at least two first inner electrodes are arranged at intervals from each other;

[0137] S002, sleeving a first insulation layer outside the at least two first inner electrodes; one end of the first inner electrode protrudes from the end surface of the first insulation layer along the axial direction of the catheter;

[0138] S003, sleeving a first outer electrode outside the first insulation layer, so that the first outer electrode, the first insulation layer and the at least two first inner electrodes form a first electrode assembly, and an electrode device is obtained; the first inner electrode and the first outer electrode are isolated by the first insulation layer, at least one end of the first insulation layer protrudes from the end surface of the first outer electrode along the axial direction, and the first inner electrode and the first outer electrode have a first discharge gap therebetween.

[0139] The method for forming the electrode device is simple and convenient, and only three steps are needed to form a first electrode assembly. If there are multiple first electrode assemblies in the electrode device, the above steps S001-S003 can be repeatedly performed to form multiple first electrode assemblies, which is convenient to assemble and has high assembly precision.

[0140] In addition, the second electrode assembly can also be formed by the same process, including connecting at least two second inner electrodes to the catheter, the at least two second inner electrodes being spaced apart from each other; then sleeving a second insulating layer outside the at least two second inner electrodes, one end of the second inner electrode protruding from the end face of the second insulating layer in the axial direction of the catheter; and finally, sleeving a second outer electrode outside the second insulating layer, so that the second outer electrode, the second insulating layer and the at least two second inner electrodes form a second electrode assembly, obtaining an electrode device with the second electrode assembly. The second electrode assembly is simple and convenient to form, and has high assembly efficiency.

[0141] Four specific embodiments are given below to introduce the shock wave system based on the above electrode device. Embodiment 1

[0142] As shown in FIG. 1 and FIG. 6, the shock wave system provided by the embodiment includes a catheter 1, a balloon 6 and an electrode device located in the balloon 6, and the balloon 6 is filled with a liquid medium that can be broken. The electrode device includes a second electrode assembly 3, the second electrode assembly 3 includes a second outer electrode 31, a second insulating layer 32 and two second inner electrodes 33, the second insulating layer 32 is sleeved on the catheter 1, the two second inner electrodes 33 are embedded between the catheter 1 and the second insulating layer 32, and the second outer electrode 31 is sleeved on the outer wall of the second insulating layer 32. In addition, the two ends of the second insulating layer 32 protrude from the two end faces of the second outer electrode 31 in the axial direction of the catheter 1, and the end close to the distal end of each of the two second inner electrodes 33 protrudes from the end face of the second insulating layer 32 in the axial direction. Then, the second inner electrode 33 and the second outer electrode 31 have a second discharge gap, which can generate a shock wave force released in the axial direction towards the distal end, thereby effectively expanding the occluded area and improving the passability of the balloon 6.

[0143] Specifically, the two second inner electrodes 33 are spaced apart in the circumferential direction, and the shortest distance between the adjacent two second inner electrodes 33 in the circumferential direction is greater than the gap length of the second discharge gap, so as to prevent abnormal breakdown in the non-discharge area between the second inner electrodes 33.

[0144] Specifically, the electrode device further comprises three first electrode assemblies 2 arranged in series with each other and spaced apart in the circumferential direction between the first electrode assemblies 2 and between the first electrode assemblies 2 and the second electrode assembly 3; the first electrode assembly 2 comprises a first outer electrode 21, a first insulating layer 22 and two first inner electrodes 23, the first insulating layer 22 is sleeved on the catheter 1, the two first inner electrodes 23 are embedded between the catheter 1 and the first insulating layer 22, and the first outer electrode 21 is sleeved on the outer wall of the first insulating layer 22; and the two ends of the first insulating layer 22 protrude beyond the two end faces of the first outer electrode 21 in the axial direction of the catheter 1, one of the two first inner electrodes 23 protrudes beyond the distal end face of the first insulating layer 22 in the axial direction at the distal end, and the other first inner electrode 23 protrudes beyond the proximal end face of the first insulating layer 22 in the axial direction at the proximal end, and the first inner electrode 23 and the first outer electrode 21 have a first discharge gap therebetween, so that the first electrode assembly 2 can release the shock wave force for treatment, while having a longer service life and better shock wave release stability.

[0145] Specifically, the two first inner electrodes 23 are arranged in the circumferential direction and spaced apart, and the shortest distance between the two adjacent first inner electrodes 23 in the circumferential direction is greater than the gap length of the first discharge gap, so as to prevent abnormal breakdown of the non-discharge area between the first inner electrodes 23; in addition, the axial shortest distance between the proximal end face of the second inner electrode 31 and the proximal end face of the second inner electrode 33 and the first inner electrode 23 and the first outer electrode 21 of the adjacent first electrode assembly 2 is greater than the first discharge gap and the second discharge gap, further avoiding abnormal breakdown of the non-discharge area and improving the discharge reliability.

[0146] Specifically, the first inner electrodes 23 of the two adjacent first electrode assemblies 2 are arranged in the circumferential direction and are misaligned, so that the first discharge gaps in the two adjacent first electrode assemblies 2 are also misaligned in the circumferential direction to perform multi-point and multi-directional discharge, facilitating the treatment of calcification in the blood vessel.

[0147] Specifically, the electrode device comprises a first electrode wire 4 for electrically connecting the first electrode assembly 2 with the power supply; as shown in FIGS. 6 and 8, the three first electrode assemblies 2 are connected in series, one of the first inner electrodes 23 of the first first electrode assembly 2 is connected with the positive electrode of the power supply through a first positive electrode wire, the other first inner electrode 23 of the first electrode assembly 2 is connected with one of the first inner electrodes 23 of the adjacent first electrode assembly 2 through a first transition wire, the other first inner electrode 23 of the adjacent first electrode assembly 2 is connected with one of the first inner electrodes 23 of the third first electrode assembly 2 through another first transition wire, and the other first inner electrode 23 of the third first electrode assembly 2 is connected with the negative electrode of the power supply through a second negative electrode wire.

[0148] Specifically, the electrode device further comprises a second electrode wire 5 for electrically connecting the second electrode assembly 3 and the power supply, the first electrode wire 4 and the second electrode wire 5 are isolated from each other, so that the second electrode assembly 3 and the first electrode assembly 2 can be controlled separately, improving the control accuracy; wherein the second electrode wire 5 comprises a second positive electrode wire and a second negative electrode wire, one second inner electrode 33 is connected with the second positive electrode wire, and the other second inner electrode 33 is connected with the first negative electrode wire, the second positive electrode wire is connected to the first inner electrode 23 of the three first electrode assemblies 2 connected with the positive electrode of the power supply (i.e. one first inner electrode 23 of the first electrode assembly 2 connected with the first positive electrode wire), so that the second electrode assembly 3 and the first electrode assembly 2 share one positive electrode of the power supply, reducing the complexity of wiring, while not affecting the individual control of the second electrode assembly 3 and the first electrode assembly 2.

[0149] Embodiment 2

[0150] The difference between this embodiment and embodiment 1 is that, as shown in FIG. 9 and FIG. 10, the electrode device comprises four first electrode assemblies 2, and the four electrode assemblies 3 are connected in series with each other, further extending the treatment range of the first electrode assembly 2.

[0151] Embodiment 3

[0152] The difference between this embodiment and embodiment 1 is that the electrode device comprises two second electrode assemblies 3 connected in series with each other, wherein the second inner electrode 33 of one second electrode assembly 3 is connected with the positive electrode of the power supply (or the first inner electrode 23 of the first electrode assembly 2 connected with the positive electrode of the power supply) through the second positive electrode wire, the second inner electrode 33 of the second electrode assembly 3 is connected with the second inner electrode 33 of the other second electrode assembly 3 through the second transition wire, and the second inner electrode 33 of the other second electrode assembly 3 is connected with the negative electrode of the power supply through the second negative electrode wire, so as to effectively turn on the two second electrode assemblies 3, accurately expand the occlusion area, and improve the passability of the balloon 6.

[0153] Embodiment 4

[0154] The difference between this embodiment and embodiment 1 is that, as shown in FIG. 11, the electrode device comprises two first electrode assemblies 2 connected in series with each other; the rest is the same as embodiment 1.

[0155] The electrode device of the embodiment is used, three samples are randomly selected, and the service life and the release stability of the shock wave are tested. The service life of the electrode device composed of two electrode assemblies in the prior art is usually less than 150 pulses, and as shown in FIG. 12, in the three samples of the embodiment, the pulse discharge times are more than 1000 times, compared with the electrode device in the prior art, the service life of the electrode device of the embodiment is greatly prolonged; and as shown in FIG. 13, during the above 1000 times of discharge, that is, within the service life of the electrode device, the three samples can release stable shock wave forces, greatly improving the discharge stability and safety of the electrode device and the shock wave system with the electrode device.

[0156] Further, after the service life of the electrode device in the embodiment and the prior art is exhausted, analysis is performed, as shown in FIG. 14 and FIG. 15, the failure mode of the first electrode assembly 2 in the embodiment mainly occurs on the first outer electrode 21, excessive discharge ablation causes the first discharge gap to be too large, thereby causing discharge difficulty, and the weak positions related to circuit conduction inside the first electrode assembly 2, that is, the connection positions of the first inner electrode 23 and the first electrode wire 4, etc. do not show serious damage. It can be seen that, compared with the electrode device in the prior art, the electrode device provided by the embodiment of the application has the advantages of long service life and good discharge stability.

[0157] The above embodiment and example improve the electrode device in the shock wave system, thereby solving the structural defects of the shock wave electrode in the existing balloon. However, the shock wave balloon also has other problems in actual application scenarios. Specifically, the treatment effect of the shock wave balloon is affected by the shock wave intensity and frequency, and one of the ways to improve the shock wave intensity of the shock wave balloon is to arrange multiple electrode assemblies in the balloon. With the increase of the number of electrode assemblies, the voltage level of the shock wave generation source required by the shock wave balloon also increases, thereby affecting the safety performance of the shock wave system.

[0158] In the related art, in order to reduce the voltage level of the shock wave generation source, multiple electrode assemblies are arranged in different shock wave generation channels. However, with the increase of the number of shock wave generation channels, the number of electrode assembly wires also increases, and multiple pairs of electrode wires occupy the inner cavity space of the balloon, thereby reducing the liquid medium flow area and affecting the inflation and deflation speed of the balloon. Because the size of the balloon is limited, the treatment effect of the shock wave balloon is limited. In addition, because the voltage level of the shock wave generation source is not enough, the number of series connection of the electrode assemblies is controlled to be less than two, thereby causing low shock wave energy superposition efficiency, small energy coverage area per unit time, and limited treatment effect.

[0159] To solve the above technical problems, the embodiment of the present application also provides an impact wave emitting device, as shown in Figure 16, which comprises a catheter 100, a balloon 200 and a plurality of electrode assemblies 300, the balloon 200 and the plurality of electrode assemblies 300 are sleeved on the catheter 100, the electrode assemblies 300 are arranged in the inner cavity of the balloon 200, and the plurality of electrode assemblies 300 extend along the length direction of the catheter 100, the plurality of electrode assemblies 300 are connected in series to form an impact wave generating channel, after receiving a high-voltage pulse signal, the pulse of the plurality of electrode assemblies 300 breaks through the fluid medium in the balloon and releases an impact wave force, the impact wave force makes the fluid in the balloon 200 vibrate, and the mechanical energy generated by the fluid vibration is transmitted to the lesion through the balloon wall. Based on the above configuration, the plurality of electrode assemblies 300 of the impact wave generating channel are connected in series, on the one hand, the occupancy rate of the inner cavity space of the balloon 200 can be reduced, the series connection of the plurality of electrode assemblies 300 can be realized through a pair of electrode wires (one positive electrode wire and one negative electrode wire), so that the balloon 200 has a larger liquid flow area, and the inflation and deflation process of the balloon 200 is facilitated; on the other hand, the plurality of series-connected electrode assemblies 300 can release the impact wave at the same time under one pulse signal, and the impact waves released by the plurality of electrode assemblies 300 can be superimposed, so that the waveform pulse width of the superimposed impact wave is longer, the energy density is higher, and the force on a larger area of calcified lesions in a unit time is improved, thereby improving the effectiveness and treatment efficiency of the impact wave device.

[0160] In the related art, the plurality of electrode assemblies 300 in the impact wave generating channel are connected in parallel, for example, the impact wave generating channel contains three parallel-connected electrode assemblies 300, and the three parallel-connected electrode assemblies 300 release the impact wave in turn with time. Since the three electrode assemblies 300 do not break down at the same time, only a specific position can receive the impact wave force at any time, the intensity of the impact wave released by the impact wave generating channel changes in a wave shape along the length direction of the balloon 200, and the coverage of the impact wave released by the impact wave generating channel is narrow. Figure 17 shows the impact wave intensity distance distribution of the three parallel-connected electrode assemblies 300 under the action of 6KV voltage, as shown in Figure 17, at the points A and B shown in the figure, the impact wave intensity is less than 2MPa.

[0161] In the embodiment of the present application, since the plurality of electrode assemblies 300 are connected in series, the plurality of electrode assemblies 300 can release the shock waves at the same time, the shock waves of the plurality of electrode assemblies 300 are superimposed on each other, and the force of the superimposed shock waves on the balloon 200 is balanced. Referring to FIG. 18, the intensity of the shock waves released by the shock wave generation channel varies along the length direction of the balloon 200 in the embodiment, and the superimposed shock waves have another advantage that the coverage of the shock waves released by the shock wave generation channel is wide. As shown in FIG. 18, the shock wave intensity at the A point and the B point is greater than 2 MPa. It should be understood that, in order to achieve the above-mentioned superimposed shock wave effect, the number of the electrode assemblies 300 connected in series in the shock wave generation channel should be more than three, and in some preferred embodiments, the number of the electrode assemblies 300 connected in series in the shock wave generation channel is more than five.

[0162] In the embodiment of the present application, one shock wave generation channel corresponds to at least one pulse signal emitting source, and the present application does not limit the shock wave emitting device to include only one shock wave generation channel, that is, the shock wave emitting device can include two or more shock wave generation channels. When the shock wave emitting device includes two or more shock wave generation channels, the structure of the electrode assemblies 300 in each shock wave generation channel is not limited to be consistent, specifically, the number of the electrode assemblies 300 in each shock wave generation channel is not limited to be consistent, for example, one shock wave generation channel includes two electrode assemblies 300, and another shock wave generation channel includes three electrode assemblies 300; and the connection relationship of the electrode assemblies 300 in each shock wave generation channel is not limited to be consistent, for example, one shock wave generation channel includes two electrode assemblies 300 connected in parallel, and another shock wave generation channel includes three electrode assemblies 300 connected in series. It should be understood that, when the shock wave emitting device includes two or more shock wave generation channels, and the electrode assemblies 300 in a certain shock wave generation channel are connected in parallel, the shock wave generation channel can be connected to multiple pulse signal emitting sources. In addition, it is worth noting that the above-mentioned pulse signal emitting source can be understood as a signal emitting device, or as a signal emitting connection port.

[0163] In some embodiments of the present application, the plurality of electrode assemblies 300 of the shock wave emitting device are arranged into at least two shock wave generation channels. The shock wave generation channel in the present disclosure should be understood as a path channel for converting a high-voltage pulse signal into a shock wave. The electrode assemblies included in one shock wave generation channel release shock waves according to a corresponding rule under the action of a pulse signal.

[0164] In the embodiments of the present disclosure, the at least one shock wave generating channel includes three or more electrode assemblies 300, and the three or more electrode assemblies 300 are connected in series. Based on the above embodiments, one shock wave generating channel corresponds to at least one pulse signal emitting source, that is, the shock wave generating channel is connected to the corresponding pulse signal generating source through a pair of electrode wires. With the increase in the number of shock wave generating channels, the number of electrode wires connected to the pulse signal generating source of the shock wave emitting device also increases, and the occupancy rate of the electrode wires to the lumen space of the balloon 200 also increases.

[0165] In the above embodiments, in order to reduce the occupancy rate of the electrode wires to the lumen space of the balloon 200 without reducing the voltage level and the shock wave energy density, at least two shock wave generating channels of the shock wave emitting device share one electrode wire, which is any one of the positive electrode wire and the negative electrode wire. In a specific embodiment, as shown in FIG. 20, the shock wave emitting device includes six electrode assemblies 300, each of which includes one first electrode and two second electrodes for connecting the electrode wires. Generally, the electrode assembly 300 adopts a ring electrode structure, and the first electrode can be any one of the inner electrode 303 and the outer electrode 301, and the second electrode is the other one of the inner electrode 303 and the outer electrode 301, for example, the first electrode is the outer electrode 301, and the second electrode is the inner electrode 303. Five of the electrode assemblies 300 are connected in series as one shock wave generating channel, and the other one is separately used as another shock wave generating channel, and the two shock wave generating channels share the same negative electrode wire. Based on the above configuration, one end of each electrode assembly 300 is connected to at most two electrode wires, which can effectively reduce the occupancy rate of the electrode wires to the lumen space of the balloon 200 and improve the inflation and deflation effect of the balloon 200. According to the above two shock wave generating channel scheme, the same reasoning can be applied to the scheme of the shock wave emitting device including three or more shock wave generating channels, and the embodiments of the present disclosure do not make more redundant descriptions.

[0166] In the embodiments of the present application, the multiple shock wave generating channels are provided for the following reasons. The shock wave effect released by the electrode assembly 300 in the shock wave generating channel depends on the number and position of the electrode assembly 300 in the channel, and thus different shock wave generating channels can release shock wave forces with different pressures and energy densities. For example, when there are two shock wave generating channels, one shock wave generating channel contains only one electrode assembly 300, and the other shock wave generating channel contains multiple electrode assemblies 300 connected in series, the shock wave effects released by the two shock wave generating channels are different, which can be adapted to different treatment needs. For example, in some possible cases, for the calcified serious areas of the coronary vessels and peripheral vessels, the space available for the balloon 200 to pass through is limited, and it is necessary to send shock waves at the distal end of the balloon 200 to expand the passage so that the balloon 200 can pass through the calcified serious area smoothly. Or, in some possible cases, for the calcified serious areas of the peripheral vessels, it is necessary to increase the intensity of the shock waves released by the shock wave generating channel, otherwise the balloon 200 is difficult to expand, resulting in an insignificant treatment effect. By providing multiple different shock wave generating channels in the shock wave emitting device, the shock wave characteristics of different shock wave generating channels can be utilized to improve the treatment effect.

[0167] In some embodiments of the present application, the multiple electrodes of the shock wave emitting device are arranged into at least two shock wave generating channels, including a first shock wave generating channel and a second shock wave generating channel. The first shock wave generating channel includes the electrode assembly 300 at the distal end of the catheter 100. The first shock wave generating channel is used to release shock waves towards the distal end of the balloon 200 to expand the passage, thereby facilitating the balloon 200 to pass through the narrow blood vessel smoothly.

[0168] The number of electrode assemblies 300 in the first shock wave generating channel is not limited in the present embodiment. There can be only one electrode assembly 300 at the distal end of the balloon 200 in the first shock wave generating channel, or there can be multiple continuous electrode assemblies 300 including the electrode assembly 300 at the distal end of the balloon 200. In some preferred embodiments, the number of electrode assemblies 300 in the first shock wave generating channel is less than two.

[0169] Based on the above embodiments, the second shock wave generating channel includes five or more electrode assemblies 300, and the shock wave generating channel formed by the five or more electrode assemblies 300 releases shock waves with high average intensity. In the embodiments of the present disclosure, the five or more electrode assemblies 300 can be arranged at equal intervals or at unequal intervals. When the electrode assemblies 300 are arranged at equal intervals, it is helpful to make the distribution of the shock wave force even.

[0170] Please refer to Fig. 18, which is the intensity distribution of the shock wave released by one shock wave generation channel containing five electrode assemblies 300 along the length direction of the balloon 200. The shock wave intensity changes in a trend of gentle rise and gentle decline in sequence, and the average intensity of the shock wave is high, which is greater than 2 MPa. Please refer to Fig. 19, which is the intensity distribution of the shock wave released by one shock wave generation channel containing five electrode assemblies 300 along the length direction of the balloon 200 under the driving of a pulse signal with a higher voltage. The shock wave intensity still changes in a trend of gentle rise and gentle decline in sequence, and the average intensity of the shock wave is higher.

[0171] In the embodiments of the present application, as the number of electrode assemblies 300 in the shock wave generation channel increases, the voltage level of the pulse signal required by the shock wave generation channel is higher. The voltage level of the pulse signal is related to the number of electrode assemblies 300 on one hand, and is related to the structure of the electrode assembly 300 itself on the other hand.

[0172] Specifically, the electrode assembly 300 includes an outer electrode 301, an insulating layer 302, and at least two inner electrodes 303. The inner electrodes 303 are arranged on the inner side of the insulating layer 302, and the outer electrode 301 is sleeved on the outer side of the insulating layer 302. There is a discharge gap between each inner electrode 303 and the outer electrode 301, and the discharge gaps of each inner electrode 303 and the outer electrode 301 are consistent. Based on the above arrangement, the electrode assembly 300 includes two or more inner electrodes 303, which helps to realize the series connection between the electrode assemblies 300, thereby reducing the number of electric wires in the shock wave generation channel. When the electrode assembly 300 includes only two inner electrodes 303, please refer to Fig. 21, one inner electrode 303 of the proximal electrode assembly 300 is connected to the positive electrode line, and the other inner electrode 303 is connected to one inner electrode 303 of the adjacent electrode assembly 300. Similarly, one inner electrode 303 of the distal electrode assembly 300 is connected in sequence, and then the other inner electrode 303 of the distal electrode assembly 300 is connected to the negative electrode line, so as to realize the series connection of multiple electrodes.

[0173] The embodiments of the present application do not limit the structure selection of the electrode assembly 300. Specifically, the pulse release point of the electrode assembly 300 is not limited, that is, how the discharge gap between the inner electrode 303 and the outer electrode 301 is formed is not limited. For example, the inner electrode 303 can protrude axially from the outer electrode 301 to form a discharge gap with the outer electrode 301, that is, the pulse release point is located at both ends of the outer electrode 301; or a discharge hole can be formed in the outer electrode 301 to form a discharge gap with the inner electrode 303, that is, the pulse release point is located at the central hole of the outer electrode 301.

[0174] In some specific embodiments, the pulse release point of the electrode assembly 300 is located at the center opening of the outer electrode 301. Please refer to FIG. 22, which shows a structural diagram of the electrode assembly 300 with center opening discharge. The insulating layer 302 is sleeved on the catheter 100, and the two inner electrodes 303 are arranged on the inner side of the insulating layer 302. The insulating layer 302 is a tubular structure, and the inner electrodes 303 are curved sheet structures. The inner electrodes 303 are embedded between the insulating layer 302 and the catheter 100. The outer electrode 301 is sleeved on the outer side of the insulating layer 302, and the outer electrode 301 is a tubular structure. Two first through holes 3011 are formed on the outer electrode 301, and the first through holes 3011 correspond to the inner electrodes 303 one by one. The two first through holes 3011 are respectively aligned with the middle positions of the two inner electrodes 303. Two second through holes 3021 are formed on the insulating layer 302, and the positions of the two second through holes 3021 correspond to the positions of the two first through holes 3011 one by one. The discharge gap is formed between the first through hole 3011 of the outer electrode 301 and the inner electrode 303. After the pulse signal is applied to the inner electrode 303 and the outer electrode 301, the shock wave is released from the first through hole 3011.

[0175] In the above specific embodiments, the axial length of the insulating layer 302 is the longest, and the axial length of the inner electrode 303 is the shortest. Each inner electrode 303 is connected to one inner electrode 303 of the adjacent electrode assembly 300 through one electrically conductive wire, that is, the series connection wire, and the two inner electrodes 303 of the same electrode assembly 300 are respectively connected to the inner electrodes 303 of different electrode assemblies 300.

[0176] In other specific embodiments, the pulse release point of the electrode assembly 300 is located at the two ends of the outer electrode 301. Please refer to FIG. 23, which shows a structural diagram of the electrode assembly 300 with two-end discharge. The insulating layer 302 is sleeved on the catheter 100, and the two inner electrodes 303 are arranged on the inner side of the insulating layer 302. The insulating layer 302 is a tubular structure, and the inner electrodes 303 are curved sheet structures. The inner electrodes 303 are embedded between the insulating layer 302 and the catheter 100. The outer electrode 301 is sleeved on the outer side of the insulating layer 302, and the outer electrode 301 is a tubular structure. The axial length of the insulating layer 302 is the longest, and the axial length of the inner electrode 303 is the shortest.

[0177] For any inner electrode 303, one end protrudes axially from the insulating layer 302, and the protruding end of the inner electrode 303 forms a discharge gap with the end of the adjacent outer electrode 301. The other end of the inner electrode 303 is covered by the insulating layer 302, and the other end is connected to the series connection wire for connecting to one inner electrode 303 of the adjacent electrode assembly 300. The two inner electrodes 303 of the same electrode assembly 300 can protrude axially from the insulating layer 302 in the same direction, or can protrude axially from the insulating layer 302 in opposite directions, respectively.

[0178] It should be understood that the number of inner electrodes 303 of the same electrode assembly 300 is not limited to two, and can be more than three.

[0179] In addition, the circumferential angle between the inner electrodes 303 of the electrode assembly 300 is not limited in the embodiment. Specifically, in a first aspect, the circumferential arrangement of the inner electrodes 303 of the same electrode assembly 300 is not limited, and the inner electrodes 303 of the same electrode assembly 300 can be uniformly arranged in the circumferential direction, so as to realize uniform release of the shock wave; or the inner electrodes 303 of the same electrode assembly 300 can be arranged at a specific angle, so as to realize directional release of the shock wave. In a second aspect, the circumferential arrangement of the inner electrodes 303 of different electrode assemblies 300 is also not limited, that is, the inner electrodes 303 of different electrode assemblies 300 can be arranged along the same ridge line outside the catheter 100, and in this case, only M inner electrodes 303 can be seen in the projection in the axial direction of the catheter 100, M being the number of inner electrodes 303 in each electrode assembly 300; or the inner electrodes 303 of different electrode assemblies 300 can also be arranged in a staggered manner in the circumferential direction. Please refer to FIG. 24, as shown in the figure, each electrode assembly 300 includes two inner electrodes 303, the two inner electrodes 303 are arranged oppositely, and the inner electrodes 303 of different electrode assemblies 300 are arranged in a staggered manner in the circumferential direction, and the staggered angle is 90°.

[0180] In the embodiment of the application, since one shock wave generating channel includes a plurality of electrode assemblies 300 connected in series, and the shock wave generating channel is driven based on a pulse signal source, under the action of the pulse voltage applied by the pulse signal source, the discharge gap of the plurality of electrode assemblies 300 connected in series is filled with electric sparks, and then the liquid medium in the inner cavity of the balloon 200 is broken down, the more the number of electrode assemblies 300 connected in series, the greater the discharge gap that needs to be broken down, and the higher the difficulty of breakdown. Please refer to FIG. 25, which shows the minimum applied voltage required by a single electrode assembly 300 at different discharge gaps, and a plurality of electrode assemblies 300 connected in series can be regarded as a total electrode assembly 300, and as the number of electrode assemblies 300 connected in series increases, the discharge gap of the total electrode assembly 300 also increases, and the minimum applied voltage required also increases.

[0181] Specifically, when N electrode assemblies 300 are included in a shock wave generation channel, each electrode assembly 300 includes one outer electrode 301 and M inner electrodes 303, the discharge gap between each inner electrode 303 and the outer electrode 301 is L1, the discharge gap of each electrode assembly 300 is M*L1 (mm), and the total discharge gap L2 of the shock wave generation channel is N*M*L1 (mm). At this time, the voltage U1 of the pulse signal generation source matched with the shock wave generation channel is K1*L2=K1*M*N*L1=MN*K1*L1 (KV), where K1 is a discharge coefficient, and the range of K1 is 4-8 KV / mm. In order to reduce the difficulty of structural design of the electrode assembly 300, M can be selected as 2, that is, each electrode assembly 300 includes one outer electrode 301 and two inner electrodes 303. At this time, the difficulty of series connection between the electrode assemblies 300 is low, and the number of required conductive wires is small.

[0182] In some possible embodiments, the range of L1 is 0.05-0.1 mm. In some preferred embodiments, K1=6 and L1=0.075 mm.

[0183] With the increase of the total discharge gap of the shock wave generation channel, the voltage required for the breakdown of the discharge gap is greater, which can cause the outer electrode 301 of the electrode assembly 300 and the electrode connecting wire of the electrode assembly 300 to be more easily broken down. In addition, the shock wave energy increases after the voltage is increased, and the electrode ring is more easily worn out. Therefore, the outer electrode 301 also needs to be designed to be longer. Therefore, in order to prolong the service life of the electrode assembly 300 and improve the safety of the shock wave emission device, the axial length of the insulating layer 302 of the electrode assembly 300 is also designed to be longer.

[0184] Specifically, based on the above embodiments, the axial length of the inner electrode 303 of a single electrode assembly 300 is A mm, the axial length of the insulating layer 302 is B mm, and the axial length of the insulating layer 302 is B=A+K2U1, where K2 is an insulation coefficient, the range of K2 is 0.5-0.8 mm / KV, and the unit of U1 is KV. When N electrode assemblies 300 are included in a shock wave generation channel, the axial length of the insulating layer 302 of each electrode assembly 300 in the shock wave generation channel is B=A+M*N*K1*K2*L1.

[0185] In some possible embodiments, the range of L1 is 0.05-0.1 mm, the range of K1 is 4-8 KV / mm, and the range of K2 is 0.5-0.8 mm / KV. Therefore, the range of the axial length of the insulating layer 302 is A+(0.1-0.64)*MN (mm), that is, the range of the axial length difference between the insulating layer 302 and the inner electrode 303 is MN*0.1 mm-MN*0.64 mm.

[0186] In one specific embodiment, the shock wave generating channel includes five electrode assemblies 300, the shock wave generating channel matches the voltage U1=4.5 kV of the pulse signal source, and the axial length of the insulating layer 302 of each electrode assembly 300 is set to B=2.25-3.6 mm. The above parameter range is based on experiments. After setting multiple control groups and conducting power operation, multiple experimental groups that can stably discharge for more than 1,000 times and each time release a pulse intensity greater than a reference threshold are obtained. The minimum and maximum values of the axial length of the insulating layer 302 of the electrode assembly 300 in the experimental groups are determined, and the above parameter range is obtained.

[0187] In the above embodiment, the purpose of increasing the axial length of the insulating layer 302 in the single electrode assembly 300 is to prolong the service life of the electrode assembly 300. In related technologies, factors that restrict the service life of the electrode assembly 300 include mechanical impact resistance and ablation resistance.

[0188] Mechanical impact resistance specifically refers to that, at the moment of discharging the shock wave by the electrode assembly 300, the instantaneous high impact pressure and high temperature will cause damage to the weak part of the electric wire. Generally, the weak part of the electric wire is the position where the electric wire is connected to the electrode assembly 300, that is, the connection position between the electric wire and the inner electrode 303 in the embodiment. In the continuous discharge process of the electrode assembly 300, the damage to the weak part of the electric wire accumulates continuously until the weak part of the electric wire breaks down and fails, thereby causing the electrode assembly 300 to be unable to discharge, i.e., the service life of the electrode assembly 300 is exhausted.

[0189] Ablation resistance specifically refers to that, after the electrode assembly 300 is applied with a high-voltage pulse signal, the discharge gap between the outer electrode 301 and the inner electrode 303 is broken down and discharged. During the discharge process, the outer electrode 301 and / or the inner electrode 303 will be ablated to different degrees under the action of current and high temperature, thereby increasing the discharge gap. In the continuous discharge process of the electrode assembly 300, the degree of ablation accumulates continuously until the discharge gap between the outer electrode 301 and the inner electrode 303 is too large, and the electrode assembly 300 cannot normally discharge under the action of the high-voltage pulse signal with the same parameters, and the electrode assembly 300 fails.

[0190] The ablation resistance of the electrode assembly 300 can be improved by increasing the axial length of the insulating layer 302 in the above embodiments, thereby prolonging the service life of the electrode assembly 300. Specifically, the extension of the axial length of the insulating layer 302 helps to improve the ablation phenomenon of the edges of the outer electrode 301 of the electrode assembly 300. Due to the high voltage level of the pulse signal connected to the shock wave generating channel, the instantaneous high voltage causes the components of the electrode assembly 300 to ablate, among which the ablation of the edges of the outer electrode 301 is the most serious, resulting in an excessively large discharge gap of the electrode assembly 300, thereby causing the electrode assembly 300 to be difficult to discharge or even fail. After the extension of the axial length of the insulating layer 302, the ablation of the edges of the outer electrode 301 is alleviated as the shock wave attenuates after discharge, the number of pulse discharges that can be achieved by the electrode assembly 300 is increased, and the service life of the electrode assembly 300 is prolonged.

[0191] To further enhance the stability of the electrode assembly 300, in some embodiments of the present application, a protective sleeve 400 is arranged between adjacent electrode assemblies 300, the edges of the outer electrode 301 of the adjacent electrode assemblies 300 are covered at both ends of the protective sleeve 400, and the protective sleeve 400 is used to wrap the series connection line between the adjacent electrode assemblies 300. The protective sleeve 400 can improve the mechanical impact resistance and ablation resistance of the electrode assembly 300. Specifically, the edges of the outer electrode 301 of the adjacent electrode assemblies 300 can be wrapped by connecting the two ends of the protective sleeve 400, which can effectively improve the ablation phenomenon of the edges of the outer electrode 301, thereby improving the ablation resistance of the electrode assembly 300. In addition, since a plurality of series-connected electrode assemblies 300 are included in one shock wave generating channel, the plurality of series-connected electrode assemblies 300 work simultaneously, which will bring greater instantaneous shear force to the series connection line. By wrapping the series connection line between the adjacent electrode assemblies 300 with the protective sleeve 400, the possibility of the series connection line between the adjacent electrode assemblies 300 being cut by physical impact force can be reduced, the mechanical impact resistance of the electrode assembly 300 can be improved, and the service life of the electrode assembly 300 can be prolonged. It should be understood that the protective sleeve 400 is made of an insulating material, and the edges of the outer electrode 301 are also insulated from the protective sleeve 400. In addition, the embodiments of the present application do not limit the protective sleeve 400.

[0192] In some possible embodiments, the protective sleeve 400 can be configured as a heat shrink tube, and the two ends of the heat shrink tube are connected to the edges of the outer electrode 301 by glue or dispensing. Specifically, referring to FIG. 26, the axial length C of the heat shrink tube is equal to D-Y mm, D is the axial spacing of the adjacent electrode assemblies 300, and Y is the distance left for the glue, which can be selected as 1 mm. By using the heat shrink tube in combination with the glue connection mode, the electrode assembly 300 can be protected at a lower cost, the service life of the electrode assembly 300 can be prolonged, and the stability of the shock wave emitting device can be enhanced.

[0193] The above-mentioned multiple embodiments have explained in detail the shock wave emitting device of the present application, and the features of the above-mentioned multiple embodiments can be freely combined to form new schemes without conflict.

[0194] According to the above content, the shock wave emitting device of the present application includes multiple shock wave generating channels, and multiple pulse signal generating sources are required; and the shock wave emitting device includes the shock wave generating channels formed by multiple series-connected electrode assemblies 300, and the required driving signal of the shock wave generating channels is a high-voltage pulse signal, and the driving signal needs to meet the requirements of high voltage and high frequency at the same time; in addition, multiple different shock wave generating channels work in different application scenarios, and the pulse signal generating source needs to flexibly set the parameters of the pulse signal according to the different needs of the application scenarios; in addition, because the service life of the shock wave generating channel is affected by the number of series-connected electrode assemblies 300 in the channel, the pulse signal generating source also needs to monitor the state parameters of the shock wave generating channel to flexibly adjust the pulse signal, so the control requirement of the shock wave emitting device of the present application for the pulse signal generating source is high. In the face of the above requirements, the pulse power supply of the related art cannot realize fast charging and discharging on one hand when realizing high-voltage pulse, and on the other hand, it also cannot realize flexible monitoring, control and adjustment of the pulse signal parameters.

[0195] In order to solve the above problems, the embodiment of the present application further provides a shock wave system, which includes a pulse generating device and the shock wave emitting device of any one of the above-mentioned embodiments, and the shock wave emitting device is electrically connected with the pulse generating device, and the pulse generating device is used to provide a high-voltage pulse signal for the shock wave emitting device. The pulse generating device of the embodiment of the present application can realize output of 1KV~20KV voltage within milliseconds, and through the adjustment of the control signal by the control module 500, it can realize adjustable output voltage and adjustable shock wave pulse release frequency within 1~30Hz, and the shock wave system can adjust the pulse signal of the pulse generating device according to the use position and use state of the shock wave emitting device, so that the shock wave system can flexibly cope with multiple different treatment situations.

[0196] Specifically, please refer to Figure 27, the pulse generating device includes a control module 500, a charge-discharge module 600, a trigger module 700 and a pulse output module 800, the control module 500 is electrically connected with the charge-discharge module 600, the trigger module 700 and the pulse output module 800 respectively, the control module 500 first sends a charging control signal to the charge-discharge module 600, the charge-discharge module 600 charges after receiving the charging control signal, the control module 500 sends a trigger signal to the trigger module 700, the trigger module 700 triggers the charge-discharge module 600 to discharge after receiving the trigger signal, and the control module 500 finally sends a shock wave control signal to the pulse output module 800, and the pulse output module 800 controls the opening and closing of the shock wave generating channel in the shock wave emitting device after receiving the shock wave control signal.

[0197] In the embodiment of the application, the control module 500 is a function module for realizing adjustable voltage and frequency, and has the functions of receiving, processing and outputting electrical signals, and generates the above-mentioned multiple different control signals based on automatic operation or manual instruction. The application does not limit the specific selection of the control module 500, and the control module 500 can be an industrial computer, an upper computer, a microcomputer system, a single-chip microcomputer and a programmable circuit, etc. In some preferred embodiments, in order to reduce the size of the system, the control module 500 is selected to be an MCU control module, i.e. a single-chip microcomputer control module, which can reduce the cost and enhance the high-frequency signal processing performance based on the single-chip microcomputer control module.

[0198] Based on the above-mentioned embodiments, further, the control module is externally connected with at least one monitoring component, and the monitoring component is used for monitoring at least one of the working state of the pulse generating device, the real-time lesion information of the treatment area of the shock wave system and the working state of the shock wave emitting device. The working state of the pulse generating device includes parameter information of the pulse generating device and / or each function component therein, and the parameter information includes but is not limited to output voltage, instantaneous current, start signal, trigger signal, temperature, pulse width duration, etc. Based on the above-mentioned setting, the control module can intelligently identify the shock wave emitting device connected to the pulse generating device, and automatically match the appropriate treatment pulse parameters in combination with the monitored working state of the pulse generating device, the real-time lesion information of the treatment area of the shock wave system and the working state of the shock wave emitting device, to generate corresponding charging control signals, trigger signals and shock wave control signals.

[0199] In a specific embodiment, the control module is connected with a first monitoring component, a second monitoring component and a control console, the first monitoring component is used to identify the model of the shock wave emitting device, the second monitoring component is used to obtain the working state of the shock wave emitting device, and the control console is used to send real-time lesion information of a treatment area and real-time control instructions of an operator to the control module, the control module judges whether the model of the shock wave emitting device is correct according to the real-time lesion information of the treatment area, and automatically matches appropriate treatment pulse parameters, the treatment pulse parameters are data stored in the control module in advance, when the operator sends the real-time control instructions through the control console, the treatment pulse parameters are subject to parameters contained in the real-time control instructions, and in the case that the working state of the shock wave emitting device obtained by the second monitoring component is normal, the control module generates corresponding charging control signals, trigger signals and shock wave control signals, and the shock wave system enters a shock wave treatment process.

[0200] In the embodiment of the application, the charge-discharge module 600 is a functional module for realizing a high-frequency high-voltage pulse signal, and the charge-discharge module 600 comprises a pulse width modulation charging circuit and an energy storage capacitor, a charging power supply is connected to a power input end of the pulse width modulation charging circuit, a control input end of the pulse width modulation charging circuit is used to receive a charging control signal, and an output end of the pulse width modulation charging circuit is electrically connected to the energy storage capacitor, and the output end of the pulse width modulation charging circuit is used to charge the energy storage capacitor.

[0201] Specifically, the charging control signal comprises input voltage control, pulse width modulation duty cycle (PWM duty cycle) control and pulse width modulation frequency (PWM frequency) control, wherein the PMW duty cycle is used to adjust a set voltage, the input voltage U1 is set, the positive duty cycle is D, and a single pulse period is T, so that the set voltage U2 = ∫T (U1*D). The set voltage passes through an amplification circuit to control an output voltage, and an amplification coefficient K (generally 10000). The PWM frequency f is used to adjust the power P of the output voltage, the output voltage is set as U3, the output current is I1, and P = (1 / f)*U3*I1.

[0202] In the embodiment of the application, the trigger module 700 and the pulse output module 800 are both used to realize the output of a pulse signal, wherein the trigger module 700 comprises a pulse switch, an output end of the trigger module 700 is electrically connected to the energy storage capacitor, a pulse switch of the trigger module 700 is connected to an input end of the pulse output module 800, and the trigger module 700 controls the pulse switch to open to release the electric energy of the energy storage capacitor after receiving a trigger signal. It should be understood that the above-mentioned pulse switch is a high-frequency pulse switch, which can realize the adjustable release frequency of the shock wave pulse in 1-30 Hz, the trigger module 700 can be a pulse switch circuit realized based on a high-frequency pulse switch, or can be an integrated pulse switch chip, and the specific configuration is selected according to the actual scene, and the embodiment does not limit this.

[0203] The output end of the pulse output module 800 is connected with the input end of the shock wave emission device, and the pulse output module 800 controls the opening and closing of the shock wave generation channel of the shock wave emission device after receiving the shock wave control signal. In the embodiment, one output end of the pulse output module 800 is one signal emission connection port described above, and the number of output ends of the pulse output module 800 is greater than or equal to the number of shock wave generation channels of the shock wave generation device. Through the shock wave control signal, single shock wave generation channel or multiple shock wave generation channels can be flexibly released and opened.

[0204] In some embodiments, the control module 500 further comprises an energy enhancement circuit, which is used to control the energy parameter of the shock wave, so that the shock wave energy emitted by the shock wave emission device changes in multiples. Specifically, in an embodiment, the control module is provided with an interactive device such as a touch screen, a handle, a switch button, etc. After the energy enhancement command is issued based on the interactive device, the energy enhancement circuit automatically adjusts the energy parameter, and the shock wave energy emitted by the shock wave emission device after adjustment is 1.5 times or higher than that in the conventional mode.

[0205] The pulse generation device of the embodiment of the present application is used to generate a high-voltage high-frequency adjustable pulse signal to drive the shock wave emission device to work for treatment. In order to ensure the safety performance of the pulse generation device, the pulse generation device further comprises an isolation device, which is used to isolate the input signal, the output signal and the environmental signal of the functional module, so as to avoid the output signal of the functional module from being affected by the input signal and / or the environmental signal to cause signal disorder and fluctuation. Therefore, the control module 500, the charge and discharge module 600, the trigger module 700 and the pulse output module 800 are all provided with isolation devices between each other, and the control module 500, the charge and discharge module 600, the trigger module 700 and the pulse output module 800 also comprise isolation devices. The isolation device can be a single or multiple separate electrical elements, or an integrated chip and / or circuit realized based on electrical elements. In some specific embodiments, the isolation device comprises at least one of the following: a semiconductor power device, an optical coupling, a relay.

[0206] In the embodiment of the present application, the isolation device is present in the entire circuit system of the pulse generating device, and based on the isolation device, the operation of any functional module is not interfered by signals of other functional modules and clutter signals in the environment, thereby ensuring the stability and safety of the pulse generating device. The isolation device can be further divided into a signal isolator, an electrical isolator and a high-voltage isolation circuit in terms of function. The signal voltage levels isolated by isolation devices with different functions are different, and the electrical elements contained are also different. The signal isolator can include but is not limited to at least one of an optical coupler, a diode, a triode and a low-voltage relay; the electrical isolator can include but is not limited to at least one of a diode, a high-voltage relay, a thyristor and a field effect transistor, and the high-voltage isolation circuit includes a high-voltage relay.

[0207] It should be understood that the signal isolator, the electrical isolator and the high-voltage isolation circuit described above can be provided by selecting only one of them or by selecting a combination of a plurality of them.

[0208] In a specific embodiment, the isolation device provided in the charge-discharge module 600 is selected to be a signal isolator and an electrical isolator. Specifically, a signal isolator is provided between the control module 500 and the pulse width modulation charging circuit, an electrical isolator is provided between the pulse width modulation charging circuit and the energy storage capacitor, and the pulse width modulation charging circuit is provided with an independent isolation power supply.

[0209] In another specific embodiment, the isolation device provided in the trigger module 700 includes a signal isolator and an electrical isolator. The signal isolator includes an optical coupler, and the electrical isolator includes a thyristor and an isolation transformer. Since the trigger module 700 is used to control the charge-discharge module 600 to release the electrical energy in the energy storage capacitor, the trigger module 700 needs to be isolated from the charge-discharge module 600 by the above-mentioned isolation device to avoid mutual interference between the two signals.

[0210] In another specific embodiment, the isolation device provided between the pulse output module 800 and the shock wave emitting device includes a signal isolator, an electrical isolator and a high-voltage isolation circuit. The signal sent from the pulse output module 800 flows to the shock wave emitting device after being processed by the signal isolator, the electrical isolator and the high-voltage isolation circuit in turn. Since the pulse output module 800 works in a high-voltage circuit, multiple isolation is needed to ensure normal operation.

[0211] In some embodiments of the present application, the shock wave system further comprises a connector 900 connected with the pulse generating device and the shock wave emitting device respectively, a chip assembly is arranged in the connector 900, the chip assembly is used to acquire state parameters of the shock wave emitting device connected with the connector 900, the state parameters include at least one of the following: the number of released pulses, the powered time, the consumable model of the electrode assembly 300, the catheter balloon model; the chip assembly is in communication connection with the control module 500, and the chip assembly is used to send the state parameters to the control module 500. Based on the above setting, the shock wave emitting device is connected with the pulse generating device to start timing and calculate the number of released pulses, and the consumables of the shock wave generating device are determined to be invalid after the preset time, so as to ensure the sterile effect of the product.

[0212] Based on the above, the shock wave emitting device of the present application can flexibly adjust the static parameters such as the structure of the electrode assembly 300, the number of the electrode assembly 300 and the number of the shock wave generating channels according to the actual treatment needs. The treatment area, service life, pulse generating source and other state parameters corresponding to the shock wave emitting devices with different static parameters are also different, and the required pulse signal parameters are also different. Therefore, after the different shock wave emitting devices are connected with the pulse generating device and the same shock wave emitting device works several times, the pulse signal parameters need to be flexibly monitored, controlled and adjusted to achieve the effect of intelligent matching of the pulse signal. According to the above embodiment, when the control module 500 is externally connected with a specific external detection device, the control module can intelligently identify the shock wave emitting device connected with the pulse generating device, receive the monitored device working state and real-time lesion information of the system treatment area, and automatically match the appropriate treatment pulse parameters according to the information, including matching the shock wave emitting devices at different positions, the pulse voltage, the pulse current, the pulse frequency and the pulse duration.

[0213] In order to further realize the intelligent matching of the pulse signal, the present application further provides a control method of a shock wave system, the shock wave system comprising a pulse generating device and a shock wave emitting device connected through a connector 900, the pulse generating device comprising a control module 500, the control module 500 storing a preset configuration file, the control module 500 being in communication connection with the connector 900, the connector 900 being used to acquire the state parameters of the shock wave emitting device, and the control module 500 being externally connected with a monitoring module, the monitoring module being used to acquire the static parameters of the shock wave emitting device.

[0214] Please refer to FIG. 28, the control method of the above shock wave system comprises:

[0215] S101, in the case that the shock wave emitting device is connected to the pulse generating device, acquiring static parameters of the shock wave emitting device, the static parameters of the shock wave emitting device at least including the number of shock wave generating channels, the number of electrode assemblies in the shock wave generating channels, and the structure of the electrode assemblies in the shock wave generating channels;

[0216] S102, based on the preset configuration file and the acquired static parameters, configuring working parameters of the pulse generating device, and controlling the pulse generating device to send a pulse signal to the shock wave emitting device;

[0217] S103, in the case that the shock wave emitting device releases a shock wave, acquiring state parameters of the shock wave emitting device, the state parameters of the shock wave emitting device at least including the number of pulses released, the time of being powered on, and the type of consumables of the electrode assemblies;

[0218] S104, based on the preset state comparison condition obtained from the preset configuration file, in the case that the acquired state parameters meet the preset state comparison condition, controlling the pulse generating device to stop sending a pulse signal to the shock wave emitting device.

[0219] In the control method, the working parameters of the pulse generating device include at least one of the following: input voltage, PWM duty ratio, PWM frequency, pulse period, output voltage, output current, and output power.

[0220] In the control method, the preset state comparison condition includes the number of discharges of the electrode assemblies and the total power-on time of the shock wave emitting device, which aims to limit the long-time work of the shock wave emitting device and avoid the failure of the electrode assemblies and the reduction of the sterile performance of the shock wave emitting device. In a specific embodiment, the preset state comparison condition includes that the number of discharges of any electrode assembly in the shock wave emitting device reaches 1000 times, and / or the power-on time of the shock wave emitting device after being connected to the pulse generating device reaches 6 hours.

[0221] In some possible embodiments, the control module is further connected to a control console, and the control console is configured to send real-time lesion information of a treatment area and real-time control instructions of an operator to the control module. Based on the control console, please refer to FIG. 29, the control method of the shock wave system further includes:

[0222] S201, in the case that the shock wave emitting device is connected to the pulse generating device, acquiring real-time lesion information of a treatment area monitored by the control console;

[0223] S202, based on a preset configuration file and the real-time lesion information of the treatment area, configuring working parameters of the pulse generating device;

[0224] S203, acquire the real-time control instruction input by the console, adjust the working parameter of the pulse generating device based on the real-time control instruction, and control the pulse generating device to send a pulse signal to the shock wave launching device.

[0225] The embodiments of the present application also provide a storage medium, which stores at least one instruction or at least one program, and the at least one instruction or the at least one program is loaded and executed by a processor to implement the above-mentioned control method for a shock wave system; optionally, the storage medium can be located in at least one network server in a plurality of network servers of a computer network; in addition, the storage medium can include, but is not limited to, a random access memory (RAM), a read-only memory (ROM), a non-volatile memory (NVM), a U disk, a mobile hard disk, a disk storage device, a flash memory device, other volatile solid-state storage devices, and various storage media capable of storing program codes.

[0226] It should be noted that the above-mentioned sequence of the embodiments of the present application is only for description, not representing the advantages and disadvantages of the embodiments. The above-mentioned embodiments are described in the specification. Other embodiments are within the scope of the appended claims. In some cases, the actions or steps recorded in the claims can be executed in an order different from that in the embodiments and still achieve the desired results. In addition, the processes depicted in the drawings do not necessarily require the specific order or continuous order shown to achieve the desired results. In some embodiments, multi-task processing and parallel processing are possible or can be advantageous.

[0227] The embodiments of the present application have been described above, the above description is exemplary, not exhaustive, and is not limited to the disclosed embodiments. Many modifications and changes are obvious to those skilled in the art without departing from the scope and spirit of the described embodiments. The selection of terms used herein is intended to best explain the principles of the embodiments, practical application or improvement of technology in the market, or to enable other ordinary skilled in the art to understand the embodiments disclosed herein.

Claims

1. A shockwave emitting device comprising a catheter, a balloon, and a plurality of electrode assemblies, the balloon being sleeved on the catheter, the plurality of electrode assemblies being disposed in a lumen of the balloon, characterized in that, The plurality of electrode assemblies are sleeved on the catheter and extend along the length direction of the catheter; The plurality of electrode assemblies are arranged into at least two shock wave generating channels, the electrode assemblies of each shock wave generating channel are connected in series, at least one of the shock wave generating channels comprises a plurality of electrode assemblies, and the at least two shock wave generating channels share one electrode line.

2. The shockwave launch device of claim 1, wherein, The at least two shock wave generating channels comprise a first shock wave generating channel and a second shock wave generating channel, the first shock wave generating channel comprises the electrode assembly at the distal end of the catheter, and the second shock wave generating channel comprises more than three electrode assemblies.

3. The shockwave launch according to claim 1 or 2, wherein, The electrode assembly comprises an outer electrode, an insulation layer and at least two inner electrodes, the inner electrodes are arranged on the inner side of the insulation layer, and the outer electrode is sleeved on the outer side of the insulation layer, and the discharge gap between each inner electrode and the outer electrode is uniform.

4. The shockwave launch according to claim 3, wherein, The axial length B of the insulation layer is obtained based on the following formula: B=A+M*N*K1*K2*L1, wherein A is the axial length of the inner electrode of the electrode assembly, the unit of A is mm, M is the number of inner electrodes contained in one electrode assembly, N is the number of electrode assemblies contained in one shock wave generating channel, K1 is a discharge coefficient, the range of K1 is 4-8KV / mm, K2 is an insulation coefficient, the range of K2 is 0.5-0.8mm / KV, and L1 is the discharge gap distance between the inner electrode and the outer electrode in the electrode assembly, the range of L1 is 0.05-0.1mm; the axial length difference between the insulation layer and the inner electrode ranges from MN*(0.1-0.64)mm.

5. The shockwave launch according to claim 3, wherein, A protective sleeve is arranged between adjacent electrode assemblies, two ends of the protective sleeve are connected to the outer electrode edges of adjacent electrode assemblies respectively, the protective sleeve is used for wrapping the series connection line between adjacent electrode assemblies, and the axial length C of the protective sleeve is obtained based on the following formula: C=D-Y, wherein D is the axial spacing of adjacent electrode assemblies, and Y is the axial length of the connecting piece between the protective sleeve and the electrode assembly.

6. The shockwave launch device of claim 3, wherein, At least two first through holes are formed in the outer electrode, the first through holes correspond to the inner electrodes one by one, each first through hole is aligned with the corresponding inner electrode, at least two second through holes are formed in the insulation layer, the second through holes correspond to the first through holes one by one, and the discharge gap is formed between the first through holes and the inner electrodes.

7. The shockwave launch device of claim 3, wherein, The inner electrode protrudes axially from the insulation layer, and the protruding end of the inner electrode forms a discharge gap with the end of the adjacent outer electrode.

8. The shockwave launch device of claim 7, wherein, The electrode assembly comprises at least one group of first electrode assemblies and at least one group of second electrode assemblies, the at least one group of first electrode assemblies and the at least one group of second electrode assemblies are arranged at intervals in the axial direction, and the second electrode assemblies are located at the distal end of the catheter relative to the first electrode assemblies.

9. The shockwave launch device of claim 8, wherein, The first electrode assembly comprises a first outer electrode, a first insulation layer and at least two first inner electrodes arranged in intervals, the first inner electrodes and the first outer electrode are separated by the first insulation layer, and a first discharge gap is formed between the first inner electrodes and the first outer electrode. The second electrode assembly comprises a second outer electrode, a second insulation layer and at least two second inner electrodes arranged in intervals, the second inner electrodes and the second outer electrode are separated by the second insulation layer, and a second discharge gap is formed between the second inner electrodes and the second outer electrode.

10. The shockwave launch device of claim 9, wherein, At least one end of the first insulation layer protrudes from an end surface of the first outer electrode along an axial direction of the catheter; among the at least two first inner electrodes, part of the first inner electrodes protrude from a proximal end surface of the first insulation layer, and the rest of the first inner electrodes protrude from a distal end surface of the first insulation layer.

11. The shockwave launch device of claim 10, wherein, The adjacent two first inner electrodes are arranged in a circumferential direction of the catheter, and the shortest distance between the adjacent two first inner electrodes in the circumferential direction corresponds to a central angle of 30°-90°.

12. The shockwave launch device of claim 10, wherein, The shock wave emitting device comprises at least two groups of first electrode assemblies, and the first inner electrodes of the at least two groups of first electrode assemblies are arranged in a circumferential direction of the catheter.

13. The shock wave emitting device according to claim 9, wherein The second insulation layer protrudes from an end surface of the second outer electrode along an axial direction at a distal end, and the second inner electrodes protrude from an end surface of the second insulation layer at a distal end to generate a shock wave acting force released towards the distal end, and the at least two second inner electrodes all protrude from the same end surface of the second insulation layer.

14. The shockwave launch device of claim 9, wherein, The shortest distance between the adjacent two second inner electrodes in the circumferential direction of the catheter is greater than the gap length of the second discharge gap, and the gap length of the second discharge gap is the minimum distance of a discharge path between the second inner electrodes and the second outer electrode.

15. The shockwave launch device of claim 9, wherein, The first inner electrodes of the first electrode assembly are connected to a first electrode wire, and the first electrode wire is connected to an end of the first inner electrodes which does not protrude from the first insulation layer; The second inner electrodes of the second electrode assembly are connected to a second electrode wire, and the second electrode wire is connected to an end of the first inner electrodes which does not protrude from the first insulation layer.

16. The shockwave launch device of claim 8, wherein, The forming method of the first electrode assembly comprises: connecting at least two first inner electrodes to a catheter; the at least two first inner electrodes are arranged in intervals; sleeving a first insulation layer outside the at least two first inner electrodes; one end of the first inner electrodes protrudes from an end surface of the first insulation layer along an axial direction of the catheter; sleeving a first outer electrode outside the first insulation layer, so that the first outer electrode, the first insulation layer and the at least two first inner electrodes form a first electrode assembly; the first inner electrodes and the first outer electrode are separated by the first insulation layer, at least one end of the first insulation layer protrudes from an end surface of the first outer electrode along the axial direction, and a first discharge gap is formed between the first inner electrodes and the first outer electrode.

17. A shockwave system characterized in that, The shock wave emission device is connected with the pulse generation device through the connector, and the pulse generation device is used to provide a high-voltage pulse signal for the shock wave emission device.

18. The shockwave system of claim 17, wherein, The chip assembly is arranged in the connector and is used to acquire state parameters of the shock wave emission device, and the state parameters include at least one of the following: the number of released pulses, the powered-on time, the consumable model of the electrode assembly, and the catheter balloon model.

19. The shockwave system of claim 18, wherein, The pulse generation device includes a control module, a charging and discharging module, a trigger module, and a pulse output module. The control module stores a preset configuration file, is in communication connection with the chip assembly of the connector, is used to acquire state parameters of the shock wave emission device and send the state parameters to the control module, and is further connected with a monitoring module, which is used to acquire static parameters of the shock wave emission device.

20. The shockwave system of claim 19, wherein, The control module is electrically connected with the charging and discharging module and the pulse output module, is used to send a charging control signal to the charging and discharging module and a shock wave control signal to the pulse output module, and includes an energy enhancement circuit, which is used to control the energy parameters of the shock wave so that the energy of the shock wave emitted by the shock wave emission device changes in multiples.

21. The shockwave system of claim 20, wherein, The charging and discharging module includes a pulse width modulation charging circuit and an energy storage capacitor, a charging power supply is connected to a power input end of the pulse width modulation charging circuit, a control input end of the pulse width modulation charging circuit is used to receive the charging control signal, an output end of the pulse width modulation charging circuit is electrically connected with the energy storage capacitor, and the output end of the pulse width modulation charging circuit is used to charge the energy storage capacitor.

22. The shockwave system of claim 21, wherein, The trigger module includes a pulse switch, an output end of the trigger module is electrically connected with the energy storage capacitor, the pulse switch is connected with the pulse output module, and the trigger module is used to control the pulse switch to open to release the electric energy of the energy storage capacitor after receiving the trigger signal. An output end of the pulse output control module is connected with an input end of the shock wave emission device, and the pulse output control module is used to control the opening and closing of a shock wave generation channel of the shock wave emission device after receiving the shock wave control signal.

23. The shockwave system of claim 19, wherein, The pulse generation device further includes an isolation device, and the control module, the charging and discharging module, the trigger module, the pulse output module, and each module are provided with the isolation device between any two of them, and the isolation device includes at least one of the following: a signal isolator, an electrical isolator, and a high-voltage isolation circuit.

24. The shock wave system according to claim 23, characterized in that, The shock wave system adopts the following control method: In a case where the shock wave emitting device is connected to the pulse generating device, static parameters of the shock wave emitting device are acquired, the static parameters of the shock wave emitting device including at least one of a number of shock wave generating channels, a number of electrode assemblies in the shock wave generating channels, a structure of the electrode assemblies in the shock wave generating channels, and a catheter balloon model; Based on the preset configuration file and the acquired static parameters, working parameters of the pulse generating device are configured, and the pulse generating device is controlled to send a pulse signal to the shock wave emitting device; In a case where the shock wave emitting device releases a shock wave, state parameters of the shock wave emitting device are acquired, the state parameters of the shock wave emitting device including at least one of a number of released pulses, a powered-on time, a consumable model of an electrode assembly, and a catheter balloon model; Based on a preset state comparison condition acquired from the preset configuration file, in a case where the acquired state parameters satisfy the preset state comparison condition, the pulse generating device is controlled to stop sending a pulse signal to the shock wave emitting device.

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