Electrode structure and shock wave release device

Abstract

The invention discloses an electrode structure and a shock wave release device, the electrode structure is sleeved on a support member, the electrode structure comprises an inner insulation assembly sleeved on the outer wall of the support member, an electrode assembly sleeved on the outer wall of the inner insulation assembly, and an outer insulation member coated on the outer wall of the electrode assembly, the electrode assembly comprises a first electrode, a second electrode and at least one transition electrode, the at least one transition electrode is arranged between the first electrode and the second electrode at intervals in the axial direction of the supporting piece, and a first discharge gap is formed by the minimum interval between the first electrode and the adjacent transition electrode; a second discharge gap is formed by the minimum interval between the second electrode and the adjacent transition electrode; the outer insulating part is provided with a plurality of radial through release through holes which are used for exposing the first discharge gap or the second discharge gap. The outer wall of the electrode assembly is coated with the outer insulating part, assembly is convenient, movement, deformation and disintegration of the electrode assembly in the using process are effectively restrained, and the service life of the electrode structure and the shock wave releasing device is prolonged.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to an electrode structure and a shock wave release device. Background Art

[0002] Cardiac valve calcification is the main pathological cause of cardiac valve stenosis and regurgitation, etc., and usually occurs in the elderly population; vascular calcification is a common pathological cause existing in atherosclerosis, hypertension, diabetic vascular lesions, vascular injury, chronic kidney disease, and aging, etc.

[0003] Currently, due to the advantages of easy operation and balloon pre - dilation, the shock wave balloon technology has been used to treat cardiac valve or vascular calcification. The key to realizing this shock wave balloon technology is the electrode structure installed in the balloon assembly of the shock wave release device. During the treatment process, the support is pushed to the treatment site of the patient, and a liquid medium (such as normal saline, contrast agent - normal saline mixture) is filled into the balloon assembly until the balloon assembly contacts the treatment site; then the energy generator is turned on, so that the electrode structure works and generates high - energy shock waves. These high - energy shock waves enter the calcified lesion area, that is, the treatment site, through the balloon assembly, and break the calcified structure, thereby softening the treatment site.

[0004] The intensity of the shock wave pressure released by this electrode structure and the service life of the shock wave release device are the key points determining the treatment effect and the safety of the device. However, the existing shock wave release device has a high assembly process difficulty and an unstable assembly process. The shock wave release device has a low life under a high - intensity shock wave release environment, and there is a great risk of electrode disintegration, making it difficult to provide a stable, continuous, and high - intensity shock wave pressure; moreover, the discharge path of the existing shock wave release device is mostly axial discharge, which has many restrictions on the length dimension of the internal electrode, and will also cause the service life of the shock wave release device to be further shortened. Summary of the Invention

[0005] Aiming at the problems existing in the above - mentioned prior art, the present invention provides an electrode structure and a shock wave release device, which are convenient to assemble, can effectively inhibit the movement, deformation, and disintegration of the electrodes in the electrode structure during use, and extend the service life of the electrode structure and the shock wave release device.

[0006] An electrode structure provided by the present invention is sleeved on a support. The electrode structure includes an inner insulation assembly, an outer insulation member, and an electrode assembly. The inner insulation assembly is sleeved on the outer wall of the support, the electrode assembly is sleeved on the outer wall of the inner insulation assembly, and the outer insulation member covers the outer wall of the electrode assembly.

[0007] The electrode assembly includes a first electrode, a second electrode, and at least one transition electrode. The at least one transition electrode is disposed between the first electrode and the second electrode in the axial direction of the support member, and the first electrode and the second electrode are respectively spaced apart from the transition electrode. The minimum distance between the first electrode and the adjacent transition electrode forms a first discharge gap, and the minimum distance between the second electrode and the adjacent transition electrode forms a second discharge gap. At least one of the first discharge gap and the second discharge gap forms a discharge path in the circumferential direction of the support member;

[0008] The outer insulating member is provided with a plurality of radially penetrating release through-holes for exposing the first discharge gap or the second discharge gap.

[0009] Further, the first electrode, the second electrode, and the transition electrode are respectively in interference fit with the outer insulating member.

[0010] Further, the gap length of the first discharge gap is the shortest distance of the first discharge path in the circumferential direction between the first electrode and the adjacent transition electrode; the gap length of the second discharge gap is the shortest distance of the second discharge path in the circumferential direction between the second electrode and the adjacent transition electrode.

[0011] Further, the gap length of the first discharge gap and / or the gap length of the second discharge gap is 0.2 mm to 0.8 mm.

[0012] Further, the first discharge gap and the second discharge gap are located in the same azimuth in the circumferential direction of the support member.

[0013] Further, the first discharge gap and the second discharge gap are arranged in a staggered manner in the circumferential direction of the support member.

[0014] Further, the electrode assembly includes at least two transition electrodes, and the adjacent two transition electrodes are spaced apart from each other. The minimum distance between the adjacent two transition electrodes forms a third discharge gap.

[0015] Further, the transition electrode includes a first transition discharge portion, a connecting portion, and a second transition discharge portion that are connected in sequence. The connecting portion is sleeved on the outer wall of the inner insulating assembly. The first transition discharge portion axially extends from the connecting portion toward the first electrode, and the second transition discharge portion axially extends from the connecting portion toward the second electrode.

[0016] Further, the first electrode includes a first fixing portion and a first discharging portion. The first fixing portion is sleeved on the outer wall of the inner insulating component, and the first discharging portion axially extends from the first fixing portion toward the second electrode;

[0017] The shortest distance between the first discharging portion and the first transitional discharging portion of the adjacent transitional electrode forms the first discharge gap. The first discharge gap is used to accommodate a liquid medium, so that under the energized state, the first discharging portion and the first transitional discharging portion of the adjacent transitional electrode are conducted through the liquid medium at the first discharge gap to form a current loop.

[0018] Further, the second electrode includes a second fixing portion and a second discharging portion. The second fixing portion is sleeved on the outer wall of the inner insulating component, and the second discharging portion axially extends from the second fixing portion toward the first electrode;

[0019] The shortest distance between the second discharging portion and the second transitional discharging portion of the adjacent transitional electrode forms the second discharge gap. The second discharge gap is used to accommodate a liquid medium, so that under the energized state, the second discharging portion and the second transitional discharging portion of the adjacent transitional electrode are conducted through the liquid medium at the second discharge gap to form a current loop.

[0020] Further, the axial distance between the first discharging portion of the first electrode and the connecting portion is greater than the gap length of the first discharge gap and less than the axial length of the first discharging portion;

[0021] The axial distance between the second discharging portion of the second electrode and the connecting portion is greater than the gap length of the second discharge gap and less than the axial length of the second discharging portion.

[0022] Further, axially penetrating notches are respectively provided on the first fixing portion of the first electrode, the second fixing portion of the second electrode and the connecting portion. The width of the notch in the state where the outer insulating member is pressed is smaller than the width of the notch in the state where the outer insulating member is not pressed.

[0023] Further, the inner insulating component includes a first insulating member and a second insulating member. The first insulating member is sleeved on the outer wall of the support member, the second insulating member is sleeved on the outer wall of the first insulating member, and the first electrode, the second electrode and the transitional electrode are respectively sleeved on the outer wall of the second insulating member.

[0024] Furthermore, the electrode structure further includes an electrical connection component for electrically connecting to a power source. The electrical connection component includes a first connection member and a second connection member. The first connection member is disposed between the first electrode and the second insulating member and is electrically connected to the first electrode. The second connection member is disposed between the first insulating member and the second insulating member, and protrudes from the second insulating member in the axial direction of the support member to be electrically connected to the second electrode.

[0025] The present invention also provides a shock wave release device, including a support member, a balloon assembly, and the electrode structure according to any one of the above. The electrode structure is disposed on the outer wall of the support member and is located inside the balloon assembly.

[0026] Implementing the present invention has the following beneficial effects:

[0027] 1. In the present invention, an outer insulating member with release through-holes is coated on the outer wall of the electrode assembly, and only the non-discharge area of the electrode assembly is tightly coated, which can effectively limit the relative displacement of the first electrode, the transition electrode, and the second electrode during use, and thus effectively inhibit the crosstalk, deformation, and disintegration of the electrode assembly during use, maintaining the discharge stability of the first discharge gap and the second discharge gap. And at least one of the first discharge gap and the second discharge gap provides a circumferential discharge path, which can reduce the limitation on the length of the electrode assembly itself, thereby being beneficial to improving the structural stability and overall ablation resistance of the first electrode, the transition electrode, and the second electrode. The coating method of the outer insulating member and the circumferential discharge method cooperate with each other to further synergistically improve the stability of the overall electrode assembly during use, enabling the discharge structure to stably and continuously output a high-intensity shock wave pressure, improving the overall discharge effectiveness and discharge stability of the electrode structure, and greatly extending the service life of the electrode structure and the shock wave release device under high-intensity working conditions. Moreover, the electrode structure, especially the electrode assembly and the outer insulating member, form a nested structure, which is convenient to assemble and has a low difficulty, being beneficial to improving the structural accuracy of the electrode structure, the use effectiveness, and the use stability of the electrode structure. In addition, the structure of the electrode structure is simple and the assembly convenience is high, being beneficial to improving the assembly efficiency and saving production costs.

[0028] 2. The first discharge gap and the second discharge gap are located in the same azimuth in the circumferential direction of the support member, enabling directional discharge, so that the shock wave pressure is concentrated on the treatment area on one side. The positioning and release accuracy of the shock wave pressure is high, and it can especially be applied to treat cardiac valve calcification or small-angle or mass calcification where the strength of calcified tissue is much higher than that of intravascular calcification, meeting the working conditions of local high voltage and high shock wave pressure required for treating small-angle or mass calcification or cardiac valve calcification. Moreover, the axially arranged first discharge gap and second discharge gap extend the influence area of the shock wave pressure in the axial direction, which is beneficial to increasing the redundancy of treatment operations and meeting the treatment requirements of treatment areas with various sizes.

[0029] 3. The present invention is provided with a plurality of transition electrodes in the axial direction and a third discharge gap is formed between the transition electrodes, which can further increase the number of discharge gaps in the axial direction and extend the release length of the shock wave pressure in the axial direction to achieve a longer influence area of the shock wave pressure and meet the treatment requirements of large-sized treatment areas.

[0030] 4. The first discharge gap and the second discharge gap are optionally arranged in a staggered manner in the circumferential direction of the support member. The setting is flexible and convenient, enabling non-directional discharge, and is applicable to treating intravascular calcification with relatively weak calcified tissue strength and large circumferential angle coverage. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] In order to more clearly illustrate the technical solutions of the present invention, the drawings used in the embodiments will be briefly introduced below, where the same components are denoted by the same reference numerals. Obviously, the drawings described below are only some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts.

[0032] Figure 1 Schematic three-dimensional structure diagram of an electrode structure provided by the present invention;

[0033] Figure 2 is Figure 1 Schematic diagram of the structure inside the outer insulating member of the electrode structure in

[0034] Figure 3 Schematic diagram of a transition electrode provided by the present invention;

[0035] Figure 4 Schematic diagram of a first electrode or a second electrode provided by the present invention;

[0036] Figure 5 Schematic diagram of the electrode structure inside the outer insulating member of another electrode structure provided in Embodiment 2 of the present invention;

[0037] Figure 6Schematic diagram of the electrode structure inside the outer insulating part of another electrode structure provided in Embodiment 3 of the present invention;

[0038] Figure 7 For Figure 6 Schematic diagram of the electrode structure in the state where the middle electrode structure is pressed by the outer insulating part;

[0039] Figure 8 Schematic diagram of the structure of a shock wave release device provided by the present invention;

[0040] Figure 9 Schematic diagram of the working state of the release device acting on the treatment area in an embodiment of the present invention;

[0041] Figure 10 Schematic diagram of the working state of the shock wave release device acting on the treatment area in another embodiment of the present invention;

[0042] Figure 11 Shock wave pressure distribution diagram generated by the shock wave release device in Embodiment 1;

[0043] Figure 12 Physical form diagram of the shock wave release device in Embodiment 1 before 600 pulsed discharges at 7000V high voltage;

[0044] Figure 13 Physical form diagram of the shock wave release device in Embodiment 1 after 600 pulsed discharges at 7000V high voltage;

[0045] Figure 14 Physical form diagram of the shock wave release device without an outer insulating layer after 600 pulsed discharges at 7000V high voltage;

[0046] Figure 15 Schematic diagram of the shock wave intensity detection at a distance of 10mm from the shock wave release device provided in Embodiment 1;

[0047] Figure 16 Schematic diagram of the shock wave intensity detection at a distance of 10mm from the shock wave release device without an outer insulating layer.

[0048] Among them, the corresponding reference numerals in the figure are as follows: 1 - support member, 2 - inner insulation assembly, 21 - first insulation member, 22 - second insulation member, 3 - electrode assembly, 31 - first electrode, 310 - first fixing portion, 311 - first discharge portion, 32 - second electrode, 320 - second fixing portion, 321 - second discharge portion, 33 - transition electrode, 330 - first transition discharge portion, 331 - connecting portion, 332 - second transition discharge portion, 34 - first discharge gap, 35 - second discharge gap, 36 - third discharge gap, 27 - notch, 4 - outer insulation member, 41 - release through - hole, 42 - limiting portion, 5 - electrical connection assembly, 51 - first connecting member, 52 - second connecting member, 6 - balloon assembly. Detailed implementation manners

[0049] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present invention. It should be noted that the orientation or positional relationship indicated by the terms "upper", "lower", "left", "right", "inner", "outer", "front", "rear", "both ends", "one end", "the other end", etc. is based on the orientation or positional relationship shown in the accompanying drawings, and is only for the convenience of describing the present invention, rather than indicating or implying that the device or structure referred to must have a specific orientation, be constructed and operated in a specific orientation, so it cannot be understood as a limitation to the present invention; and the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts belong to the scope of protection of the present invention.

[0050] In the prior art, when the electrodes in some shock - wave release devices release the shock - wave pressure, they themselves bear the reverse force from the discharge gap, and it is extremely easy to form a lap - short - circuit between two adjacent electrodes after multiple discharges, resulting in the failure of the shock - wave release device and being inapplicable to the working conditions of high voltage and high shock - wave pressure; in some other shock - wave devices, an insulating layer is provided between the inner and outer electrodes, but the direct intervention of the insulating layer in the electric breakdown will cause it to bear severe burning, thereby directly affecting the position and size of the discharge gap between the inner and outer electrodes. As the number of discharges increases, the shock - wave pressure cannot be continuously and stably output; there are also some shock - wave release devices that either use flexible circuits with poor natural shock - resistance performance or simply rely on bonding to fix the electrodes, and there is a great risk that the electrodes will disintegrate and cut through the balloon assembly under the working conditions of high - intensity shock - wave pressure, with poor safety; moreover, most of the existing shock - wave release devices have great assembly process difficulty and assembly process instability.

[0051] To solve at least one of the problems faced by the above-mentioned shock wave releasing device, the present invention provides an electrode structure and a shock wave releasing device. The shock wave releasing device includes a support member 1 and an electrode structure sleeved on the support member 1. As Figure 1 shown in Figure 2 , the electrode structure includes an inner insulation component 2, an electrode component 3 and an outer insulation member 4. The inner insulation component 2 is sleeved on the outer wall of the support member 1, the electrode component 3 is sleeved on the outer wall of the inner insulation component 2, and the outer insulation member 4 is coated on the outer wall of the electrode component 3. The socket connection method is convenient for assembly, effectively alleviates the assembly difficulty, improves the assembly convenience, and is also beneficial to improving the assembly accuracy of the electrode structure, and enhancing the structural stability and structural reliability.

[0052] Specifically, as Figure 2 shown in

[0053] , the electrode component 3 includes a first electrode 31, a second electrode 32 and at least one transition electrode 33. At least one transition electrode 33 is arranged between the first electrode 31 and the second electrode 32 in the axial direction of the support member 1, and the first electrode 31 and the second electrode 32 are respectively arranged at intervals from the transition electrode 33. The minimum interval between the first electrode 31 and the adjacent transition electrode 33 forms a first discharge gap 34. When the electrode component 3 is powered on, the voltage can break down the liquid medium in the first discharge gap 34, thereby conducting the first electrode 31 and the adjacent transition electrode 33. Similarly, the minimum interval between the second electrode 32 and the adjacent transition electrode 33 forms a second discharge gap 35, and the voltage can break down the liquid medium in the second discharge gap 35, thereby conducting the second electrode 32 and the adjacent transition electrode 33; through the transition electrode 33, the first electrode 31 and the second electrode 32 can be conducted, so that the electrode component 3 forms a current loop with the power supply, and a radially outward shock wave pressure is formed at the positions of the first discharge gap 34 and the second discharge gap 35 for treating the tissue calcification of the area to be treated. Among them, at least one of the first discharge gap 34 and the second discharge gap 35 forms a discharge path along the circumferential direction of the support member 1, which can reduce the length limitation of each electrode in the electrode component, greatly improve the flexibility of the axial lengths of the first electrode 31, the second electrode 32 and at least one transition electrode 33, and is beneficial to extending the service life of the electrode component.

[0054] Specifically, the outer insulating member 4 is provided with a plurality of radially penetrating release through-holes 41. One release through-hole 41 is used to expose the first discharge gap 34, and the other release through-hole 41 is used to expose the second discharge gap 35, facilitating the outward release of the shock wave pressure. Then, when the shock wave release device with this electrode structure contacts the area to be treated, the release through-hole 41 faces the area to be treated, so that the shock wave pressure can be released towards the area to be treated, and the output effectiveness and output stability of the shock wave pressure are good; the covering structure of the outer insulating member 4 covers the discharge areas such as the first discharge gap 34 and the second discharge gap 35, and can play a fastening role, effectively restricting the relative displacement between the electrodes in the electrode assembly 3, preventing the electrode assembly 3 from experiencing abnormal crosstalk, deformation or even disintegration due to the reaction force of the shock wave pressure during the shock wave release process, and greatly prolonging the discharge effectiveness and service life of the electrode structure.

[0055] Specifically, the first electrode 31, the second electrode 32 and the transition electrode 33 are respectively in interference fit with the outer insulating member 4, further enhancing the limiting effect of the outer insulating member 4 on the electrode assembly 3 in all directions such as the circumferential direction, axial direction and radial direction of the support member 1; and the outer insulating member 4 has a plurality of release through-holes 41 that can expose the discharge areas such as the first discharge gap 34 and the second discharge gap 35, that is, the outer insulating member 4 is specifically covered and fastened to the non-discharge area. Then, at the intervals between the first electrode 31, the second electrode 32 and the transition electrode 33, the outer insulating member 4 can also fill these non-discharge areas or non-discharge gaps between the first electrode 31, the second electrode 32 and the transition electrode 33, isolating the non-discharge areas of the first electrode 31, the second electrode 32 and the transition electrode 33, effectively preventing the abnormal breakdown of the liquid medium in the non-discharge area, improving the discharge accuracy, discharge effectiveness, discharge reliability and discharge safety, greatly reducing the risks of warping, crosstalk and disintegration of the electrode assembly 3, and further prolonging the service life of the electrode structure.

[0056] In some alternative embodiments, the material of the outer insulating member 4 is a flexible material with high insulation; further, the material of the outer insulating member 4 is a heat-shrinkable material with high insulation, such as polyethylene (PE); the flexible material has good elasticity. On the one hand, it is convenient for sleeving and assembling, and on the other hand, it has good fastening, covering and filling effects, can effectively prevent the movement of the electrode assembly 3 in the axial direction, circumferential direction and radial direction (hereinafter referred to as the axial direction, circumferential direction and radial direction, all based on the support member 1) and other directions, effectively maintaining the stability and anti-deformation ability of the structure of the electrode assembly 3, and can also prevent abnormal discharge in the non-discharge area, improving the durability and long-term effectiveness of the electrode assembly 3, and prolonging the service life of the electrode structure.

[0057] Specifically, in some alternative embodiments, such as Figure 1As shown, the outer insulating member 4 is provided with limiting portions 42 at both ends in the axial direction. One of the limiting portions 42 covers one end of the first electrode 31 away from the second electrode 32, and the other limiting portion 42 covers one end of the second electrode 32 away from the first electrode 31, so as to further enhance the limiting effect of the outer insulating member 4 in the axial direction, further inhibit the axial movement of the first electrode 31 and the second electrode 32, and extend the service life of the electrode structure.

[0058] Specifically, as Figure 3 shown, the transition electrode 33 includes a first transition discharge portion 330, a connecting portion 331 and a second transition discharge portion 332 which are connected in sequence. The connecting portion 331 is sleeved on the outer wall of the inner insulating assembly 2. The first transition discharge portion 330 axially extends from the connecting portion 331 towards the first electrode 31 and is used to form a first discharge electrode pair with the first electrode 31. The second transition discharge portion 332 axially extends from the connecting portion 331 towards the second electrode 32 and is used to form a second discharge electrode pair with the second electrode 32, that is, the first transition discharge portion 330 and the second transition discharge portion 332 are arranged back to back in the axial direction. Among them, the first transition discharge portion 330 is the side of the transition electrode 33 that is closest to the first electrode 31 in the circumferential direction. The first discharge gap 34 is located between the first transition discharge portion 330 of the transition electrode 33 and the first electrode 31, so that when the power is turned on, the electric energy breaks down the liquid medium in the first discharge gap 34, so that the first transition discharge portion 330 of the transition electrode 33 is conducted with the first electrode 31 to form a current loop and release the shock wave pressure.

[0059] Specifically, as Figure 4 shown, the first electrode 31 includes a first fixing portion 310 and a first discharge portion 311. The first fixing portion 310 is sleeved on the outer wall of the inner insulating assembly 2. The first discharge portion 311 axially extends from the first fixing portion 310 towards the second electrode 32. The shortest interval between the first discharge portion 311 and the first transition discharge portion 330 of the adjacent transition electrode 33 forms the first discharge gap 34, and the first discharge gap 34 is used to accommodate the liquid medium, so that the first discharge portion 311 and the first transition discharge portion 330 of the adjacent transition electrode 33 are conducted through the liquid medium at the first discharge gap 34 in the energized state to form a current loop.

[0060] One side of the first discharge part 311 is the side of the first electrode 31 that is closest to the adjacent transition electrode 33 in the circumferential direction. That is, the first discharge gap 34 is located between the first discharge part 311 and the first transition discharge part 330. The shortest distance between the first discharge part 311 and the first transition discharge part 330 is the gap length of the first discharge gap 34. The liquid medium between the first electrode 31 and the adjacent transition electrode 33 is most likely to be broken down at the first discharge gap 34. When the power supply is turned on, the electric energy can break down the liquid medium at the first discharge gap 34 between the first discharge part 311 and the first transition discharge part 330, but will not break down the liquid medium in the gap between the part of the first electrode 31 other than the first discharge part 311 and the part of the transition electrode 33 other than the first transition discharge part 330. Thus, the first electrode 31 and the adjacent transition electrode 33 are effectively conducted at the first discharge gap 34 to form a first discharge path, and the gap length of the first discharge gap 34 is the shortest distance of the first discharge path.

[0061] Specifically, the shape of the second electrode 32 and the shape of the first electrode 31 can be selected to be the same, and the sizes can be selected to be the same or different; in some alternative embodiments, the first electrode 31 and the second electrode 32 are symmetrically arranged with respect to the plane where the radial direction of the support 1 is located.

[0062] Specifically, as Figure 4 shown, the second electrode 32 includes a second fixed part 320 and a second discharge part 321. The second fixed part 320 is sleeved on the outer wall of the inner insulation assembly 2, and the second discharge part 321 axially extends from the second fixed part 320 towards the first electrode 31. The shortest interval between the second discharge part 321 and the second transition discharge part 332 of the adjacent transition electrode 33 forms a second discharge gap 35. The second discharge gap 35 is used to accommodate the liquid medium so that the second discharge part 321 and the second transition discharge part 332 of the adjacent transition electrode 33 are conducted through the liquid medium at the second discharge gap 35 to form a current loop.

[0063] One side of the second discharge portion 321 is the side of the second electrode 32 that is closest to the adjacent transition electrode 33 in the circumferential direction. That is, the second discharge gap 35 is located between the second discharge portion 321 and the second transition discharge portion 332. The shortest distance between the second discharge portion 321 and the second transition discharge portion 332 is the gap length of the second discharge gap 35. The liquid medium between the second electrode 32 and the adjacent transition electrode 33 is most easily broken down at the second discharge gap 35. When the power supply is turned on, the electric energy can break down the liquid medium at the second discharge gap 35 between the second discharge portion 321 and the second transition discharge portion 332, but will not break down the liquid medium in the gap between the portion of the second electrode 32 other than the second discharge portion 321 and the portion of the transition electrode 33 other than the second transition discharge portion 332. Thus, the second electrode 32 and the adjacent transition electrode 33 are effectively conducted at the second discharge gap 35 to form a second discharge path, and the gap length of the second discharge gap 35 is the shortest distance of the second discharge path.

[0064] Specifically, axially penetrating notches 37 are respectively provided on the first fixing portion 310 of the first electrode 31, the second fixing portion 320 of the second electrode 32, and the connecting portion 331 of the transition electrode 33. That is, the first fixing portion 310, the second fixing portion 320, and the connecting portion 331 are respectively of an open-ring structure. The width of the notch 37 in the state where the outer insulating member 4 is pressed is smaller than the width of the notch 37 in the state where the outer insulating member 4 is not pressed. Herein, the width of the notch 37 refers to the circumferential distance between the two side walls of the notch 37 in the circumferential direction of the support member 1. Then, under the fastening pressure of the outer insulating member 4, the first fixing portion 310, the second fixing portion 320, and the connecting portion 331 are compressed, so that the width of the notch 37 is reduced, to further enhance the static friction force between the electrode assembly 3 and the inner insulating assembly 2, further increase the difficulty of the electrode assembly 3 moving or disintegrating, and extend the overall service life of the electrode assembly, the electrode structure, and the shock wave release device.

[0065] In some alternative embodiments, the inner diameters of the first fixing portion 310, the second fixing portion 320, and the connecting portion 331 in the non-pressed state are respectively greater than or equal to the outer diameter of the inner insulating assembly 2, so as to facilitate the sleeving of the electrode assembly 3 on the inner insulating assembly 2 and improve the assembly convenience. After the outer insulating member 4 is assembled, under the fastening force of the outer insulating member 4, the inner diameters of the first fixing portion 310, the second fixing portion 320, and the connecting portion 331 in the pressed state are respectively smaller than the outer diameter of the inner insulating assembly 2, so as to form an interference fit between the electrode assembly 3 and the inner insulating assembly 2, further enhance the structural reliability and structural stability, prevent the electrode assembly 3 from warping, moving, or even disintegrating due to the reaction force of the shock wave pressure during the discharge process, and extend the service life.

[0066] Specifically, as Figure 5As shown, the electrode assembly 3 includes at least two transition electrodes 33. The adjacent two transition electrodes 33 are spaced apart, and the minimum spacing between the adjacent two transition electrodes 33 forms a third discharge gap 36. When the electrode assembly 3 is powered on, the voltage can break down the liquid medium in the third discharge gap 36, thereby conducting the adjacent two transition electrodes 33 and forming a radially outward shock wave pressure at the position of the third discharge gap 36. It can be understood that the number of transition electrodes 33 can be any positive integer greater than or equal to two. Exemplarily, the electrode assembly 3 can include two transition electrodes 33, three transition electrodes 33, four transition electrodes 33, five transition electrodes 33, etc. The multiple transition electrodes 33 extend the release length of the shock wave pressure in the axial direction, increase the influence area of the shock wave pressure in the axial direction, and can achieve a longer shock wave pressure treatment area.

[0067] Specifically, as Figure 5 shown, in two adjacent transition electrodes 33, the shortest spacing between the first transition discharge part 330 of one transition electrode 33 and the second transition discharge part 332 of the other transition electrode 33 forms a third discharge gap 36. The two are arranged opposite to each other to conduct the adjacent two transition electrodes 33 and form a current loop. The liquid medium between the adjacent two transition electrodes 33 is most easily broken down at the position between the first transition discharge part 330 of one transition electrode and the second transition discharge part 332 of the other transition electrode, that is, it is most easily broken down at the third discharge gap 36. When the power is turned on, the electric energy breaks down the liquid medium located in the third discharge gap 36, thereby effectively conducting the adjacent two transition electrodes 33 to form a third discharge path. The gap length of the third discharge gap 36 is the shortest distance of the third discharge path, and the breakdown effectiveness, breakdown accuracy, and breakdown stability are good.

[0068] Preferably, as Figure 2As shown, both the first discharge gap 34 and the second discharge gap 35 form discharge paths in the circumferential direction. The gap length of the first discharge gap 34 is the shortest distance of the first discharge path in the circumferential direction between the first electrode 31 and the adjacent transition electrode 33, that is, the gap length of the first discharge gap 34 is the shortest distance of the first discharge path in the circumferential direction between the first discharge part 311 and the adjacent first transition discharge part 330; the gap length of the second discharge gap 35 is the shortest distance of the second discharge path in the circumferential direction between the second electrode 32 and the adjacent transition electrode 33, that is, the gap length of the second discharge gap 35 is the shortest distance of the second discharge path in the circumferential direction between the second discharge part 321 and the adjacent second transition discharge part 332; the circumferential discharge path can avoid restricting the discharge lengths of the first discharge gap 34 and the second discharge gap 35 in the axial direction respectively, that is, weaken the length limitation on the first discharge part 311, the first transition discharge part 330, the second discharge part 321 and the second transition discharge part 332 in the axial direction, and improve the flexibility of the length setting of the first discharge part 311, the first transition discharge part 330, the second discharge part 321 and the second transition discharge part 332; exemplarily, when the extension lengths of the respective discharge parts in the axial direction are relatively long, it is beneficial to extend the discharge areas of the first discharge gap 34 and the second discharge gap 35 in the axial direction respectively, so as to expand the influence areas of the shock wave pressure formed by the first discharge gap 34 and the influence area of the shock wave pressure formed by the second discharge gap 35 respectively. In addition, in the energized state, the electrode assembly itself is always ablated to a certain extent, and the increase in the axial length of each discharge part can provide more areas of material to be ablated, making the overall electrode assembly more durable and beneficial to extending the service lives of the first electrode 31, the second electrode 32, the transition electrode 33 and their electrode assembly.

[0069] Specifically, in some alternative embodiments, the first discharge part 311 and the first transition discharge part 330 are located at the same position in the axial direction and are adjacent to each other in the circumferential direction to facilitate forming the first discharge path in the circumferential direction; in other alternative embodiments, the second discharge part 321 and the second transition discharge part 332 are located at the same position in the axial direction and are adjacent to each other in the circumferential direction to facilitate forming the second discharge path in the circumferential direction.

[0070] Specifically, in some alternative embodiments, as Figure 5 shown, the third discharge gap 36 forms a third discharge path in the circumferential direction. The gap length of the third discharge gap 36 is the shortest distance of the third discharge path in the circumferential direction between two adjacent transition electrodes 33, which is beneficial to expanding the influence area of the shock wave pressure formed by the third discharge gap 36.

[0071] Specifically, as Figure 2As shown, the axial interval between the first discharge part 311 and the connection part 331 is greater than the gap length of the first discharge gap 34 and less than the axial length of the first discharge part 311; in some alternative embodiments, the axial distance between the first transition discharge part 330 and the first fixed part 310 is less than the axial length of the first transition discharge part 330; thus, on the one hand, only concentrated discharge can occur between the first electrode 31 and the adjacent transition electrode 33 between the first discharge part 311 and the first transition discharge part 330, avoiding abnormal discharge in other areas, which is beneficial to precisely control the discharge position and the intensity of the shock wave pressure, and improving the control accuracy and reliability of the electrode structure and the shock wave release device; on the other hand, the structure of the electrode assembly 3 is compact, improving the space utilization rate of the electrode assembly 3; in addition, the discharge parts of each electrode are relatively long, while the gaps in the mutually insulated areas are relatively short, which also makes the axial lengths of the discharge gaps in the electrode assembly 3 longer under the same length condition, being beneficial to extending the influence area of the shock wave pressure.

[0072] In some alternative embodiments, the axial interval between the second discharge part 321 and the connection part 331 is greater than the gap length of the second discharge gap 35 and less than the axial length of the second discharge part 321; in some alternative embodiments, the axial distance between the second transition discharge part 332 and the second fixed part 320 is less than the axial length of the second transition discharge part 332, jointly improving the structural compactness and discharge reliability of the electrode assembly 3.

[0073] In some alternative embodiments, between two adjacent transition electrodes 33, the axial distance between the first transition discharge part 330 of one transition electrode 33 and the connection part 331 of the other transition electrode 33 is greater than the gap length of the third discharge gap 36 and less than the axial length of this first transition discharge part 330; the axial distance between the second transition discharge part 332 of one transition electrode 33 and the connection part 331 of the other transition electrode 33 is greater than the gap length of the third discharge gap 36 and less than the axial length of this second transition discharge part 332, jointly improving the structural compactness and discharge reliability of the electrode assembly 3.

[0074] Specifically, the gap length of the first discharge gap 34 and / or the gap length of the second discharge gap 35 is 0.2 mm to 0.8 mm; in an alternative embodiment, the gap length of the third discharge gap is 0.2 mm to 0.8 mm; it can be understood that the gap length can be any point value within 0.2 mm to 0.8 mm; exemplarily, the gap length can be 0.2 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.8 mm, etc.; within this gap length range, the liquid medium located in the first discharge gap 34 and the second discharge gap 35 can be effectively broken down, thereby conducting the first discharge part 311 and the first transition discharge part 330 in the electrode assembly 3, as well as the second transition discharge part 332 and the second discharge part 321, forming a current loop, and at the same time ensuring that the liquid medium in the non-discharge area of the electrode assembly 3 is not broken down, which is beneficial to extending the service life of the electrode assembly 3 and the entire electrode structure, with good control accuracy, good discharge stability and reliability, and good use safety.

[0075] Specifically, as Figure 2 shown, in an alternative embodiment, the first discharge gap 34 and the second discharge gap 35 are located in the same azimuth in the circumferential direction of the support member 1; as Figure 5 shown, in another alternative embodiment, the first discharge gap 34, the second discharge gap 35 and the third discharge gap 36 are located in the same azimuth in the circumferential direction; at this time, the high-intensity shock wave pressure formed by the electrode structure is directionally released towards a single / same direction, that is, the electrode structure adopts a co-side discharge arrangement, which can concentrate the shock wave pressure to the treatment area, with high positioning accuracy, is beneficial to increasing the intensity of the shock wave pressure on this side, and forms a shock wave pressure influence area with a relatively long axial length, especially suitable for treating cardiac valve calcification and small-angle or mass calcification in blood vessels; and, the first discharge gap 34 and the second discharge gap 35 do not need to be symmetric in the radial direction, which reduces the waste of energy to a certain extent.

[0076] In some alternative embodiments, the first transition discharge part 330 and the second transition discharge part 332 are symmetrically arranged with respect to the plane where the radial direction of the support member 1 is located, then the first discharge gap 34 and the second discharge gap 35 are located in the same azimuth in the circumferential direction, and directional discharge can be achieved. The structure of the transition electrode 33 is simple, the processing cost is low, and the assembly is also convenient.

[0077] Specifically, in an alternative embodiment, the first discharge gap 34 and the second discharge gap 35 are arranged in a staggered manner in the circumferential direction of the support member 1; in another alternative embodiment, as Figure 6 shown, at least two of the first discharge gap 34, the second discharge gap 35 and the third discharge gap 36 are arranged in a staggered manner in the circumferential direction of the support member 1; correspondingly, as Figure 7As shown, the release through-holes 41 are also staggeredly arranged in the circumferential direction to correspondingly expose the first discharge gap 34, the second discharge gap 35 and the third discharge gap 36. The setting method is flexible and can be applied to the treatment of calcification with large-angle coverage.

[0078] In some alternative embodiments, as Figure 6 described, the first transition discharge parts 330 of two adjacent transition electrodes 33 are staggeredly arranged in the circumferential direction. During installation, the orientation of two adjacent transition electrodes 33 can be quickly changed by rotating the transition electrodes 33, so that two adjacent transition electrodes 33 are staggeredly arranged. Correspondingly, the first discharge gap 34, the second discharge gap 35 and the third discharge gap 36 are also staggeredly arranged in the circumferential direction. In some other alternative embodiments, the first transition discharge part 330 and the second transition discharge part 332 in the same transition electrode 33 are staggeredly arranged in the circumferential direction, or the curved surface lengths of the first transition discharge part 330 and the second transition discharge part 332 in the circumferential direction are not equal. For example, the curved surface length of one transition discharge part is wide, and the curved surface length of the other transition discharge part is narrow, so that the first discharge gap 34 and the second discharge gap 35 are staggeredly arranged in the circumferential direction.

[0079] Specifically, as Figure 2 shown, the inner insulation assembly 2 includes a first insulation member 21 and a second insulation member 22. The first insulation member 21 is sleeved on the outer wall of the support member 1, and the second insulation member 22 is sleeved on the outer wall of the first insulation member 21. The first electrode 31, the second electrode 32 and the transition electrode 33 are respectively sleeved on the outer wall of the second insulation member 22 to isolate the electrode assembly 3 and the support member 1, prevent the electrode assembly 3 from damaging the support member 1 during the discharge process, and is beneficial to extending the service life of the electrode structure and the shock wave release device as a whole.

[0080] Specifically, as Figure 2 and Figure 5 shown, the electrode structure further includes an electrical connection assembly 5, and the electrical connection assembly 5 is used for electrically connecting with a power supply. The electrical connection assembly 5 includes a first connection member 51 and a second connection member 52. The first connection member 51 is arranged between the first electrode 31 and the second insulation member 22, and the first connection member 51 is electrically connected to the first electrode 31. The second connection member 52 is arranged between the first insulation member 21 and the second insulation member 22, and the second connection member 52 protrudes in the axial direction of the support member 1 and is electrically connected to the second electrode 32, so that the electrode assembly 3 is connected to the power supply to form a current loop. Optionally, the first connection member 51 is connected to the positive pole of the power supply, and the second connection member 52 is connected to the negative pole of the power supply. Alternatively, the first connection member 51 is connected to the negative pole of the power supply, and the second connection member 52 is connected to the positive pole of the power supply. The present invention does not limit this.

[0081] Wherein, a space is reserved between the first insulating member 21 and the second insulating member 22 for the second connecting member 52, so that the second connecting member 52 can be led out from the same end as the first connecting member 51, improving the layout neatness and assembly convenience of the electrical connection assembly 5; in an alternative embodiment, the electrical connection assembly 5 is a wiring structure, the first connecting member 51 and the second connecting member 52 are both electrode wires, and the two electrode wires are led out from the same end of the electrode structure, greatly improving the use convenience.

[0082] Specifically, the preset voltage applied to the electrode assembly is 3 kV to 8 kV. This preset voltage cooperates with the gap length and can effectively break down the liquid medium in the first discharge gap 42 and the second discharge gap 43 to form a shock wave, which is safe and reliable.

[0083] Specifically, as Figure 8 shown, the shock wave releasing device provided by the present invention includes a support member 1, a balloon assembly 6 and the electrode structure as described above. The electrode structure is disposed on the outer wall of the support member 1 and is located inside the balloon assembly 6; wherein, the support member 1 passes through the internal cavity of the first insulating member 21, and this support member 1 is used to guide the electrode structure and the shock wave releasing device to smoothly reach the treatment area; the inside of the balloon assembly 6 is a cavity structure, and this cavity structure is used to accommodate the electrode structure, the support member 1 and the liquid medium. The liquid medium is a liquid that can be broken down by discharge to generate a shock wave, preferably normal saline, a mixed solution of normal saline and contrast agent, silicone oil, etc.

[0084] Specifically, the material of the support member 1 can be selected as an alloy material with both shape memory and a certain rigidity, such as nickel-titanium alloy; in some alternative embodiments, this shock wave device is used to treat vascular calcification, as Figure 9 shown, the support member 1 is a hollow pipe fitting to facilitate the passage of a guide wire, such as a nickel-titanium alloy tube, a polymer material tube, a tubular structure with a mixed nesting of nickel-titanium alloy and polymer material, etc.; in other alternative embodiments, this shock wave device can be used to treat cardiac valve calcification, as Figure 10 shown, the support member 1 is a solid structure, and the guide wire passes through the guide wire cavity between the balloon assemblies 6 and does not pass through the inside of the balloon assembly 6.

[0085] Specifically, as Figure 8 shown, the length of the support member 1 is greater than the length of the balloon assembly. The distal end of the balloon assembly 6 is hermetically connected to the support member 1 to prevent leakage of the liquid medium. The inner diameter of the proximal end of the balloon assembly 6 is greater than or equal to the outer diameter of the electrode structure, facilitating the assembly of the electrode structure into the balloon assembly 6. The electrical connection assembly 5 is led out from the proximal end of the balloon assembly 6 and connected to a power source.

[0086] In some alternative embodiments, as Figure 10As shown, according to different treatment areas, multiple shock wave release devices can be connected in parallel and then jointly introduced into the treatment area to achieve the release of multi-directional shock wave pressure.

[0087] When the shock wave release device is powered on, the first electrode 31, the second electrode 32 and at least one transition electrode 33 of the electrode assembly 3 are conducted through the electrical connection assembly 5; the working current passes through the first electrode 31 from the first connecting member 51. After the electric energy breaks down the liquid medium in the first discharge gap 34 at the first discharge part 311, it is introduced into the transition electrode 33 through the first transition discharge part 330, and then the second transition discharge part 332 of the transition electrode 33 breaks down the liquid medium in the second discharge gap 34 (or the third discharge gap 35), so that the working current passes through the second discharge part 321 and is introduced into the second electrode 32, and flows out to the negative pole of the power supply through the second connecting member 52 connected to the second electrode 32, or the working current is transmitted in the reverse direction, so that the shock wave release device can stably discharge and form a longer influence area of shock wave pressure in the axial direction, increasing the redundancy of the treatment operation and meeting the treatment requirements of treatment areas with various sizes; and, during the discharge process, the outer insulating member 4 always wraps and fastens the electrode assembly 3, effectively preventing the warping deformation, crosstalk and disintegration of each electrode in the electrode assembly 3, and greatly prolonging the service life of the electrode structure and the shock wave release device.

[0088] When acting on the treatment area, the balloon catheter assembled with the shock wave release device is introduced into the human body along the path of the access device by the delivery system through the hemostatic valve, and is sent to the treatment area with the assistance of the imaging device. Subsequently, under the action of the vascular imaging device, the balloon assembly expands and closely adheres to the blood vessel wall when filled with a liquid medium containing a contrast agent; the control switch system is turned on, the parameters are adjusted, and the shock wave release device starts to work and emit shock waves to treat the treatment area; after the treatment is completed, the balloon catheter is depressurized; the balloon catheter is withdrawn through the access device to complete the treatment process.

[0089] The following introduces the specific embodiments of the present invention in combination with the above specific embodiments.

[0090] Embodiment 1

[0091] As Figure 2 And Figure 8As shown in the figure, the shock wave release device provided in this embodiment includes a support member 1, a balloon assembly 6, and an electrode structure located within the balloon assembly 6. The balloon assembly 6 is filled with a liquid medium that can be broken down. The electrode structure includes a first insulating member 21, a second insulating member 22, an electrode assembly 3, and an outer insulating member 4. Among them, the support member 1 has a certain rigidity and shape memory function. The first insulating member 21 is sleeved on the outer wall of the support member 1, the second insulating member 22 is sleeved on the outer wall of the first insulating member 21, the electrode assembly 3 is sleeved on the outer wall of the second insulating member 22, and the outer insulating member 4 is coated on the outer wall of the electrode assembly 3. The assembly is convenient and can effectively limit the warping deformation and crosstalk of the electrode assembly 3.

[0092] The electrode assembly 3 includes a first electrode 31, a second electrode 32, and a transition electrode 33. The transition electrode 33 is disposed between the first electrode 31 and the second electrode 32 at intervals in the axial direction of the support member 1. The minimum interval between the first electrode 31 and the transition electrode 33 forms a first discharge gap 34, and the minimum interval between the second electrode 32 and the transition electrode 33 forms a second discharge gap 35. The gap lengths of both the first discharge gap 34 and the second discharge gap 35 are 0.2 mm. The outer insulating member 4 is provided with two radially penetrating release through-holes 41. One release through-hole 41 is used to expose the first discharge gap 34, and the other release through-hole 41 is used to expose the second discharge gap 35, facilitating the outward release of the shock wave pressure and acting on the area to be treated.

[0093] Specifically, the electrode structure is provided with two electrode wires, namely a positive electrode wire and a negative electrode wire. The positive electrode wire is disposed between the first electrode 31 and the second insulating member 22, and one end of the positive electrode wire is electrically connected to the first electrode 31, and the other end is connected to the positive pole of the power supply. The negative electrode wire is disposed between the first insulating member 21 and the second insulating member 22. The negative electrode wire extends along the axial direction and one end radially penetrates the second insulating member 22 to be electrically connected to the second electrode 32, and the other end of the negative electrode wire is connected to the negative pole of the power supply. When the power supply is connected, the high-voltage electricity applied to the first electrode 31 and the second electrode 32 simultaneously breaks down the liquid medium in the first discharge gap 34 and the second discharge gap 35, and the working current is introduced into the transition electrode 33 to achieve the conduction of the first electrode 31, the transition electrode 33, and the second electrode 32, forming a shock wave pressure at the position of the discharge gap and completing the release of the shock wave under a pulsed voltage.

[0094] Specifically, as Figures 3 - 4As shown, the first electrode 31 and the second electrode 32 have the same structure and are arranged axially symmetrically; the first electrode 31 includes a first fixing part 310 and a first discharging part 311, the first fixing part 310 is sleeved on the outer wall of the inner insulating component 2, and the first discharging part 311 axially extends from the first fixing part 310 towards the second electrode 32; the second electrode 32 includes a second fixing part 320 and a second discharging part 321, the second fixing part 320 is sleeved on the outer wall of the inner insulating component 2, and the second discharging part 321 axially extends from the second fixing part 320 towards the first electrode 31; the transition electrode 33 includes a first transition discharging part 330, a connecting part 331 and a second transition discharging part 332 which are connected in sequence, the connecting part 331 is sleeved on the outer wall of the inner insulating component 2, the first transition discharging part 330 axially extends from the connecting part 331 towards the first electrode 31 and is used to form a first discharging electrode pair with the first electrode 31, and the circumferential gap between the first transition discharging part 330 and the first discharging part 311 is the first discharging gap 34; the second transition discharging part 332 axially extends from the connecting part 331 towards the second electrode 32 and is used to form a second discharging electrode pair with the second electrode 32, and the circumferential gap between the second transition discharging part 332 and the second discharging part 321 is the second discharging gap 35.

[0095] In this embodiment, axially penetrating notches 37 are respectively provided on the first fixing part 310, the second fixing part 320 and the connecting part 331. In the circumferential direction, the width of the notch 37 in the state where the outer insulating part 4 is pressed is smaller than the width of the notch 37 in the state where the outer insulating part 4 is not pressed, so as to further press the outer wall of the second insulating part 22, which is convenient for assembly and enhances the structural fastening property of the electrode assembly 3.

[0096] Specifically, as Figure 2 shown, both the first discharging gap 34 and the second discharging gap 35 form discharge paths in the circumferential direction; wherein, the first discharging part 311 and the first transition discharging part 330 are located at the same position in the axial direction and are adjacent to each other in the circumferential direction, and the gap length of the first discharging gap 34 is the shortest distance of the first discharge path in the circumferential direction between the first discharging part 311 and the first transition discharging part 330; the second discharging part 321 and the second transition discharging part 332 are located at the same position in the axial direction and are adjacent to each other in the circumferential direction, and the gap length of the second discharging gap 35 is the shortest distance of the second discharge path in the circumferential direction between the second discharging part 321 and the second transition discharging part 332; thus, it is beneficial to extend the discharge regions of the first discharging gap 34 and the second discharging gap 35 in the axial direction respectively and expand the influence region of the shock wave pressure.

[0097] Specifically, as Figure 2As shown, the axial interval between the first discharge part 311 and the connecting part 331 is greater than the gap length of the first discharge gap 34 and less than the axial length of the first discharge part 311. The axial distance between the first transition discharge part 330 and the first fixing part 310 is less than the axial length of the first transition discharge part 330. The axial interval between the second discharge part 321 and the connecting part 331 is greater than the gap length of the second discharge gap 35 and less than the axial length of the second discharge part 321. The axial distance between the second transition discharge part 332 and the second fixing part 320 is less than the axial length of the second transition discharge part 332. Thus, the structural compactness and discharge reliability of the electrode assembly 3 are synergistically improved.

[0098] Specifically, in this embodiment, as Figure 8 shown, the first discharge gap 34 and the second discharge gap 35 are located in the same azimuth in the circumferential direction of the support 1, so that the shock wave pressures at the two discharge gaps are both directionally discharged towards the same side, concentrating the shock wave pressure to the treatment area, with high positioning accuracy, which is beneficial to increasing the intensity of the shock wave pressure on this side and forming a shock wave pressure influence area with a relatively long axial length, especially suitable for treating cardiac valve calcification.

[0099] In this embodiment, the outer insulating part 4 is made of polyethylene material with high insulation performance, which can be in interference fit with the electrode assembly 3 and can also be filled in the non-discharge areas between the electrodes to define the discharge gaps and provide a fastening force for the electrode assembly 3, preventing the electrode assembly 3 from warping, moving or even disintegrating under the reaction force during the release of high-intensity shock wave pressure, and prolonging the service life of the electrode structure and the shock wave release device with this electrode structure.

[0100] As Figure 11 shown, the shock wave release device provided in this embodiment can generate a relatively strong shock wave force, which can effectively act on the treatment area in the radially outward direction for treatment. As Figure 12 and Figure 13 shown, they are the morphologies of the shock wave release device coated with the outer insulating part 4 provided in this embodiment before and after 600 pulsed discharges under a high voltage of 7000V. At this time, the shock wave release device can still work normally. As Figure 14As shown, it is the morphology of the shock wave release device without the outer insulating member 4 after 150 pulse discharges under a high voltage of 7000V. At this time, the shock wave release device can no longer discharge stably. It can be seen that the shock wave release device without the coverage of the outer insulating member 4 is more likely to form a larger discharge gap during a lower number of pulse discharges. This phenomenon will cause difficulty in breakdown, resulting in the inability of the shock wave release device to work properly. At the same time, after each electrode without the coverage of the outer insulating member 4 bears the reaction force of the shock wave, obvious crosstalk will occur and each discharge part will warp and deform, significantly increasing the risk of electrode disintegration during actual clinical use. However, the shock wave release device covered with the outer insulating member 4 provided in this embodiment can still discharge normally after a higher number of pulse discharges, and the electrode assembly does not show obvious warping deformation or crosstalk. It has good structural reliability and stability, a long service life of the shock wave release device, and is conducive to promoting the realization of high-pulse-number and high-pressure shock waves.

[0101] Furthermore, for the shock wave release device provided in this embodiment and the shock wave release device without the outer insulating member 4 coated, the shock wave pressures at a distance of 10 mm from the shock wave release device are measured respectively. The relationships between the number of pulse discharges and the average value of the peak pressures of the shock waves every 10 times are respectively as Figure 15 and Figure 16 shown. It can be seen that the shock wave release device without the outer insulating member 4 can no longer discharge after 140 pulse discharges, while the shock wave release device of this embodiment can still stably generate shock waves with higher pressures, having good persistence and high stability.

[0102] Embodiment 2

[0103] The difference between this embodiment and Embodiment 1 is that, as Figure 5 shown, the electrode assembly 3 includes two transition electrodes 33, which are arranged at intervals. The shortest interval between the first transition discharge part 330 of one transition electrode 33 and the second transition discharge part 332 of the other transition electrode 33 forms a third discharge gap 36. They are arranged opposite to each other to conduct the adjacent two transition electrodes 33 and form a current loop. The third discharge gap 36 forms a third discharge path in the circumferential direction. The gap length of the third discharge gap 36 is the shortest distance of the third discharge path in the circumferential direction between the adjacent two transition electrodes 33, which is beneficial to expanding the influence area of the shock wave pressure formed by the third discharge gap 36.

[0104] Specifically, the axial spacing between two transition electrodes 33 and between a connection portion 331 of a first transition discharge portion 330 and another transition electrode 33 is greater than the gap length of the third discharge gap 36 and less than the axial length of the first transition discharge portion 330; the axial spacing between a second transition discharge portion 332 and a connection portion 331 of another transition electrode 33 is greater than the gap length of the third discharge gap 36 and less than the axial length of the second transition discharge portion 332, which synergistically improves the structural compactness and discharge reliability of the electrode assembly 3.

[0105] Specifically, the first discharge gap 34, the second discharge gap 35, and the third discharge gap 36 are located in the same azimuth in the circumferential direction to achieve directional discharge and can be used to soften cardiac valve calcification.

[0106] Embodiment 3

[0107] Based on Embodiments 1 to 2, the difference between this embodiment and Embodiment 2 is that, as Figures 6 - 7 shown, the first discharge gap 34, the second discharge gap 35, and the third discharge gap 36 are arranged in a staggered manner in the circumferential direction of the support member 1, that is, two adjacent transition electrodes 33 are arranged in a staggered manner. Correspondingly, the release through holes 41 are also arranged in a staggered manner in the circumferential direction to correspondingly expose the first discharge gap 34, the second discharge gap 35, and the third discharge gap 36, which can achieve non-directional discharge and can be used to treat intravascular calcification with relatively weak calcified tissue strength and large circumferential angle coverage.

[0108] The above description is only some embodiments of the present invention and is not intended to limit the present invention. Those skilled in the art should understand that the present invention will have various changes and improvements, and any modifications, equivalent replacements, and improvements made in accordance with the present invention fall within the scope of protection required by the present invention.

Claims

1. An electrode structure is sleeved on a support member (1), characterized in that, The electrode structure includes an inner insulation assembly (2), an outer insulation member (4), and an electrode assembly (3). The inner insulation assembly (2) is sleeved on the outer wall of the support member (1), the electrode assembly (3) is sleeved on the outer wall of the inner insulation assembly (2), and the outer insulation member (4) covers the outer wall of the electrode assembly (3). The electrode assembly (3) includes a first electrode (31), a second electrode (32), and at least one transition electrode (33). The at least one transition electrode (33) is disposed between the first electrode (31) and the second electrode (32) in the axial direction of the support member (1), and the first electrode (31) and the second electrode (32) are respectively spaced apart from the transition electrode (33). The minimum distance between the first electrode (31) and the adjacent transition electrode (33) forms a first discharge gap (34), and the minimum distance between the second electrode (32) and the adjacent transition electrode (33) forms a second discharge gap (35). At least one of the first discharge gap (34) and the second discharge gap (35) forms a discharge path along the circumferential direction of the support member (1). The outer insulation member (4) is provided with a plurality of radially penetrating release through-holes (41), and the release through-holes (41) are used to expose the first discharge gap (34) or the second discharge gap (35).

2. The electrode structure according to claim 1, characterized in that, The first electrode (31), the second electrode (32), and the transition electrode (33) are respectively in interference fit with the outer insulation member (4).

3. The electrode structure according to claim 1, wherein The gap length of the first discharge gap (34) is the shortest distance of the first discharge path in the circumferential direction between the first electrode (31) and the adjacent transition electrode (33); the gap length of the second discharge gap (35) is the shortest distance of the second discharge path in the circumferential direction between the second electrode (32) and the adjacent transition electrode (33).

4. The electrode structure according to claim 1, characterized in that, The gap length of the first discharge gap (34) and / or the gap length of the second discharge gap (35) is 0.2 mm to 0.8 mm.

5. The electrode structure according to claim 1, wherein The first discharge gap (34) and the second discharge gap (35) are located in the same azimuth in the circumferential direction of the support member (1).

6. The electrode structure according to claim 1, characterized in that, The first discharge gap (34) and the second discharge gap (35) are arranged in a staggered manner in the circumferential direction of the support member (1).

7. The electrode structure according to any one of claims 1-6, characterized in that, The electrode assembly (3) includes at least two transition electrodes (33), and the adjacent two transition electrodes (33) are spaced apart. The minimum distance between the adjacent two transition electrodes (33) forms a third discharge gap (36).

8. The electrode structure according to any one of claims 1-6, characterized in that The transition electrode (33) includes a first transition discharge part (330), a connection part (331), and a second transition discharge part (332) that are connected in sequence. The connection part (331) is sleeved on the outer wall of the inner insulation component (2). The first transition discharge part (330) axially extends from the connection part (331) towards the first electrode (31), and the second transition discharge part (332) axially extends from the connection part (331) towards the second electrode (32).

9. The electrode structure according to any one of claims 1-6, characterized in that, The first electrode (31) includes a first fixing part (310) and a first discharge part (311). The first fixing part (310) is sleeved on the outer wall of the inner insulation component (2). The first discharge part (311) axially extends from the first fixing part (310) towards the second electrode (32). The shortest distance between the first discharge part (311) and the first transition discharge part (330) of the adjacent transition electrode (33) forms the first discharge gap (34). The first discharge gap (34) is used to accommodate a liquid medium so that, in the energized state, the first discharge part (311) and the first transition discharge part (330) of the adjacent transition electrode (33) are conducted through the liquid medium at the first discharge gap (34) to form a current loop.

10. The electrode structure according to any one of claims 1-6, characterized in that, The second electrode (32) includes a second fixing part (320) and a second discharge part (321). The second fixing part (320) is sleeved on the outer wall of the inner insulation component (2). The second discharge part (321) axially extends from the second fixing part (320) towards the first electrode (31). The shortest distance between the second discharge part (321) and the second transition discharge part (332) of the adjacent transition electrode (33) forms the second discharge gap (35). The second discharge gap (35) is used to accommodate a liquid medium so that, in the energized state, the second discharge part (321) and the second transition discharge part (332) of the adjacent transition electrode (33) are conducted through the liquid medium at the second discharge gap (35) to form a current loop.

11. The electrode structure according to claim 8, characterized in that, The axial distance between the first discharge part (311) of the first electrode (31) and the connection part (331) is greater than the gap length of the first discharge gap (34) and less than the axial length of the first discharge part (311). The axial distance between the second discharge part (321) of the second electrode (32) and the connection part (331) is greater than the gap length of the second discharge gap (35) and less than the axial length of the second discharge part (321).

12. The electrode structure according to claim 8, characterized in that, Axially penetrating notches (37) are respectively provided on the first fixing part (310) of the first electrode (31), the second fixing part (320) of the second electrode (32), and the connection part (331). The width of the notch (37) in the state where the outer insulating member (4) is pressed is smaller than the width of the notch (37) in the state where the outer insulating member (4) is not pressed.

13. The electrode structure according to any one of claims 1-6, characterized in that, The inner insulation assembly (2) includes a first insulation member (21) and a second insulation member (22). The first insulation member (21) is sleeved on the outer wall of the support member (1), and the second insulation member (22) is sleeved on the outer wall of the first insulation member (21). The first electrode (31), the second electrode (32), and the transition electrode (33) are respectively sleeved on the outer wall of the second insulation member (22).

14. The electrode structure according to claim 12, wherein, The electrode structure further includes an electrical connection assembly (5), and the electrical connection assembly (5) is used for electrically connecting to a power source. The electrical connection assembly (5) includes a first connection member (51) and a second connection member (52). The first connection member (51) is disposed between the first electrode (31) and the second insulation member (22), and the first connection member (51) is electrically connected to the first electrode (31). The second connection member (52) is disposed between the first insulation member (21) and the second insulation member (22), and the second connection member (52) protrudes from the second insulation member (22) in the axial direction of the support member (1) and is electrically connected to the second electrode (32).

15. A shock wave release device, characterized in that, It includes a support member (1), a balloon assembly (6), and the electrode structure according to any one of claims 1-14. The electrode structure is disposed on the outer wall of the support member (1), and the electrode structure is located inside the balloon assembly (6).

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