Electrode device and shock wave device

Abstract

The application discloses an electrode device and a shock wave device, which comprise at least one hard conductive piece, an electrode wire and at least two electrode assemblies, adjacent electrode assemblies are electrically connected through the hard conductive piece, and the hard conductive piece is an integral structure; the at least two electrode assemblies comprise a distal end electrode assembly and a proximal end electrode assembly, the distal end electrode assembly is coupled with a power supply through an electrode wire, and the proximal end electrode assembly is coupled with the power supply through another electrode wire. The hard conductive piece is adopted to replace an original electrode wire to realize electrical connection between adjacent two electrode assemblies, the hard conductive piece has high structural strength and good structural stability, can resist high-frequency and high-intensity shock waves, effectively reduces the risk that the electrode wire is easily disintegrated and falls off under extreme working conditions, and the service life is greatly prolonged.

Description

TECHNICAL FIELD

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

[0002] The existing shock wave device suitable for intravascular indications generally has a lower shock wave pressure of about 5 MPa, a lower required voltage, and a shorter service life. In the application of heart valve, the shock wave balloon catheter often needs to release a higher shock wave energy than that in the intravascular application, so that the shock wave device itself is subjected to a stronger reaction force, is difficult to withstand high-frequency and high-intensity discharge, and the electrode assembly in the shock wave device is mostly connected through an electrode wire (i.e. a lead wire), which has a limited strength and is difficult to withstand high-frequency and high-intensity discharge. In extreme working conditions, it is extremely easy to disintegrate and fall off, resulting in the overall failure of the shock wave device and a shorter service life. SUMMARY

[0003] In view of the problems in the prior art, the present application provides an electrode device and a shock wave device, and the technical solution is as follows:

[0004] The electrode device provided by the present application is used for a heart valve calcification treatment device, and includes at least one hard conductive part, an electrode wire, and at least two electrode assemblies. Adjacent electrode assemblies are electrically connected through the hard conductive part, and the hard conductive part is an integral structure.

[0005] The at least two electrode assemblies include a distal electrode assembly and a proximal electrode assembly. The distal electrode assembly is coupled with a power supply through one electrode wire, and the proximal electrode assembly is coupled with the power supply through another electrode wire.

[0006] Further, the distal electrode assembly and the proximal electrode assembly each include a first outer electrode, a first insulating layer located inside the first outer electrode, and a first inner electrode located inside the first insulating layer. The first inner electrode is connected with the electrode wire. The first outer electrode and the first insulating layer are provided with at least one first discharge hole penetrating in the radial direction. At least one first discharge hole exposes the first inner electrode. A first discharge gap is formed between the first outer electrode and the first inner electrode through the first discharge hole.

[0007] Further, the first outer electrode and the first insulating layer are provided with at least two first discharge holes penetrating in the radial direction. At least one of the at least two first discharge holes exposes the hard conductive part. The area of the hard conductive part exposed to the first discharge hole can be reused as a second inner electrode of the electrode assembly.

[0008] Further, the at least two electrode assemblies further comprise at least one intermediate electrode assembly, which is spaced apart from the distal electrode assembly and the proximal electrode assembly in the axial direction of the electrode device.

[0009] The intermediate electrode assembly comprises a second outer electrode and a second insulating layer inside the second outer electrode, and the second outer electrode and the second insulating layer are provided with at least one second radial through discharge hole, which exposes the hard conductive member, and the area of the hard conductive member exposed to the second discharge hole can be reused as a third inner electrode of the intermediate electrode assembly.

[0010] A second discharge gap is formed between the second outer electrode and the third inner electrode through the second discharge hole.

[0011] Further, the first inner electrode comprises an integrated discharge area and a clamping area, the first discharge hole exposes at least part of the discharge area, and the clamping area is connected with the electrode wire, and the first discharge hole is axially offset and away from the clamping area.

[0012] Further, the material of the hard conductive member comprises a hard metal, and the hard metal comprises at least one of steel, titanium alloy, copper alloy, nickel alloy and aluminum alloy.

[0013] Further, the axial spacing between the discharge holes of two adjacent electrode assemblies is less than or equal to a preset spacing, and the preset spacing is 4.8mm-5.5mm.

[0014] Further, the electrode wire comprises a leading segment and a limiting segment, the leading segment extends from the proximal end of the electrode assembly, and the limiting segment extends from the distal end of the electrode assembly.

[0015] Further, the heart valve calcification treatment device comprises a support, and the electrode device further comprises an inner insulating layer, which is arranged between the inner electrode of the electrode assembly and the support.

[0016] Further, the electrode device further comprises an insulating coating layer, which at least partially covers the electrode assembly and exposes the discharge gap of the electrode assembly, and the insulating coating layer is filled between two adjacent electrode assemblies.

[0017] In another aspect, the present application also provides an implosion device, comprising an inner tube, an expandable component connected to part of the inner tube and a support, and the electrode device as claimed in any one of the preceding claims, the expandable component has a receiving cavity therein, the support is at least partially located in the receiving cavity, and the distal end of the support is connected to the inner tube; the electrode device is arranged on the support, and in the working state, the radial distance between the electrode device and the expandable component is constant.

[0018] Further, the support comprises a limiting portion, which abuts against the inner wall of the expandable component in the radial direction, and the electrode device is located between two adjacent limiting portions in the axial direction.

[0019] Further, the support is a deformable support, which can adjust the distance between the inner wall of the expandable component by deformation; and the deformable support can move in coordination with the electrode device by deformation, so that the deformable support can be folded and close to the inner tube or be arched and away from the inner tube in coordination with the electrode device.

[0020] Further, the implosion device comprises a plurality of expandable components, which are arranged circumferentially on the side of the inner tube.

[0021] Further, the implosion device comprises a single expandable component, which is sleeved on part of the inner tube, and the receiving cavity is located between the expandable component and the inner tube.

[0022] Further, the expandable component is a special-shaped expandable component, which comprises a fitting portion and a protruding portion, the protruding portion is located between two adjacent fitting portions in the axial direction, in the expanded state of the expandable component, the radial distance between the inner wall of the protruding portion and the inner tube is greater than the radial distance between the fitting portion and the inner tube; and in the arched state of the support, the limiting portion of the support abuts against the inner wall of the fitting portion.

[0023] The implementation of the present application has the following beneficial effects:

[0024] The present application uses a hard conductive part to replace the original electrode wire to realize the electrical connection between two adjacent electrode assemblies, has high structural strength, good connection reliability, and compared with the existing split connection mode of the inner electrode and the electrode wire, the hard conductive part is an integral structure, has few weak points in structure, can further improve the structural strength and electrical connection reliability, so that the hard conductive part can withstand high-frequency and high-intensity implosion energy, effectively reduces the risk of easy disintegration and falling of the electrode wire under extreme working conditions, and effectively prolongs the service life of the electrode device. BRIEF DESCRIPTION OF DRAWINGS

[0025] In order to more clearly illustrate the technical solutions of the present application, the drawings used in the embodiments will be briefly introduced as follows, wherein the same parts are denoted by the same reference numerals. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can be obtained by those skilled in the art without any creative effort based on these drawings.

[0026] Figure 1 A structural schematic diagram of an electrode device provided in an embodiment of the present application is shown in FIG. 1.

[0027] Figure 2 A structural schematic diagram of another electrode device provided in an embodiment of the present application is shown in FIG. 2.

[0028] Figure 3 An assembly flowchart of a first inner electrode and an electrode wire in an embodiment of the present application is shown in FIG. 3.

[0029] Figure 4 A life test result schematic diagram of an electrode device provided in the present application and an existing electrode device connected with a wire is shown in FIG. 4.

[0030] Figure 5 A comparison diagram of shock wave pressures generated by some different electrode assemblies provided in the present application is shown in FIG. 5.

[0031] Figure 6 An assembly structural schematic diagram of an electrode wire in an electrode device provided in an embodiment of the present application is shown in FIG. 6.

[0032] Figure 7 An assembly structural schematic diagram of an electrode wire in an electrode device provided in an embodiment of the present application is shown in FIG. 6. Figure 6 A life test structural schematic diagram of an electrode device provided in the present application and an existing electrode device is shown in FIG. 7.

[0033] Figure 8 A structural schematic diagram of another electrode device provided in an embodiment of the present application is shown in FIG. 8.

[0034] Figure 9 An assembly structural schematic diagram of an electrode wire in an electrode device provided in an embodiment of the present application is shown in FIG. 6. Figure 8 An enlarged structural diagram of a distal electrode assembly in an embodiment of the present application is shown in FIG. 9.

[0035] Figure 10 An assembly structural schematic diagram of an electrode device and a support in an impulse wave device provided in an embodiment of the present application is shown in FIG. 10.

[0036] Figure 11 An assembly structural schematic diagram of an insulating coating layer provided in an embodiment of the present application is shown in FIG. 11.

[0037] Figure 12 An assembly structural schematic diagram of an electrode wire in an electrode device provided in an embodiment of the present application is shown in FIG. 6. Figure 11 A life test result schematic diagram of an electrode device provided in the present application and an existing electrode device is shown in FIG. 12.

[0038] Figure 13 A partial view of an embodiment of the present application;

[0039] Figure 14 A partial view of an embodiment of the present application; Figure 13 A partial view of an embodiment of the present application;

[0040] Figure 15 A partial view of an embodiment of the present application; Figure 13 A partial view of an embodiment of the present application;

[0041] Figure 16 A partial view of an embodiment of the present application; Figure 13 A partial view of an embodiment of the present application;

[0042] Figure 17 A partial view of an embodiment of the present application;

[0043] Figure 18 A partial view of an embodiment of the present application; Figure 17 A partial view of an embodiment of the present application;

[0044] Figure 19 A partial view of an embodiment of the present application; Figure 17 A partial view of an embodiment of the present application;

[0045] Figure 20 A partial view of an embodiment of the present application;

[0046] Figure 21 A partial view of an embodiment of the present application;

[0047] Figure 22 A partial view of an embodiment of the present application; Figure 21 A partial view of an embodiment of the present application;

[0048] Figure 23 A partial view of an embodiment of the present application; Figure 21 A partial view of an embodiment of the present application;

[0049] Figure 24 A partial view of an embodiment of the present application;

[0050] Figure 25 A partial view of an embodiment of the present application;

[0051] Figure 26 A partial view of an embodiment of the present application; Figure 25 A partial view of an embodiment of the present application;

[0052] Figure 27Schematic view of the shock wave device with multiple inflatable components in some possible embodiments of the present application;

[0053] Figure 28 For Figure 27 Schematic view of the cross section along B-B in the middle;

[0054] Figure 29 Schematic view of the structure of a deformable support provided in an embodiment of the present application;

[0055] Figure 30 Schematic view of the position relationship between the limiting part and the inflatable component provided in an embodiment of the present application;

[0056] Figure 31 Schematic view of the position relationship between the limiting part and the inflatable component provided in another embodiment of the present application;

[0057] Figure 32 Schematic view of the position relationship between the limiting part and the inflatable component in some possible embodiments of the present application;

[0058] Figure 33 Schematic view of the position relationship between the limiting part and the inflatable component in some possible embodiments of the present application;

[0059] Figure 34 Schematic view of the assembly steps of a shock wave device provided in an embodiment of the present application;

[0060] Figure 35 Schematic view of the assembly steps of another shock wave device provided in an embodiment of the present application;

[0061] Figure 36 For Figure 35 Schematic view of the three-dimensional structure of the integral structure of the deformable support;

[0062] Figure 37 Schematic view of the structure of the conversion between the arched state and the folded state of a shock wave device provided in an embodiment of the present application;

[0063] Figure 38 Schematic view of the structure of the conversion between the arched state and the folded state of another shock wave device provided in an embodiment of the present application;

[0064] Figure 39 Schematic view of the cross section of the second connecting piece in some possible embodiments of the present application;

[0065] Figure 40 Schematic view of the sliding mode of a second connecting piece provided in an embodiment of the present application;

[0066] Figure 41A shock wave device provided by the embodiment of the present application is used to measure the peak pressure of the shock wave at the detection point under different arch heights, and a schematic diagram is shown in the figure;

[0067] Figure 42 A schematic diagram of the change of the sound pressure energy in the inflatable part of the shock wave device provided by the embodiment of the present application under different working frequencies is shown in the figure;

[0068] Figure 43 A schematic diagram of the temperature rise of the inflatable part provided by the embodiment of the present application in 37℃ water under different working frequencies is shown in the figure;

[0069] Figure 44 A schematic diagram of the lithotripsy probability and treatment time of the shock wave device provided by the embodiment of the present application under the same number of pulses and different pulse frequencies is shown in the figure.

[0070] In the figure, the reference signs correspond to:

[0071] 1-hard conductive part, 11-second inner electrode, 12-third inner electrode, 2-electrode wire, 21-leading-out section, 22-limiting section, 3-electrode assembly, 31-distal electrode assembly, 310-first outer electrode, 311-first insulating layer, 312-first inner electrode, 3120-discharge area, 3121-clamping area, 313-first discharge hole, 32-proximal electrode assembly, 33-intermediate electrode assembly, 330-second outer electrode, 331-second insulating layer, 332-second discharge hole, 4-inner insulating layer, 5-supporting part, 51-deformable supporting part, 52-supporting section, 53-bending section, 54-connecting section, 55-limiting section, 6-insulating coating layer, 7-inner tube, 8-inflatable part, 81-receiving cavity, 82-adhering section, 83-protruding section, 84-first connecting part, 85-second connecting part, 86-pushing and pulling part, 9-outer tube, 91-first gap, 92-annular guide part, 93-second gap. DETAILED DESCRIPTION

[0072] The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. It should be noted that the terms “upper”, “lower”, “left”, “right”, “inner”, “outer”, “front”, “back”, “two ends”, “one end”, “the other end” and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only used to facilitate the description of the present application, and do not indicate or imply that the devices or structures referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation on the present application. Moreover, the described embodiments are only a part of the embodiments of the present application, not all embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative labor fall within the scope of the present application.

[0073] In view of the problem that in the existing shock wave device, the electrode assemblies are electrically connected through electrode wires, the inner electrode and the electrode wire are connected in a split body, there is a weak connection point, and the electrode wire is prone to disintegration and falling off, resulting in failure of the shock wave device, the electrode device and the shock wave device are provided, the electrode device is used for a heart valve calcification treatment device, the heart valve calcification treatment device belongs to a shock wave device, and the electrode device includes at least one hard conductive piece 1, an electrode wire 2 and at least two electrode assemblies 3. Figure 1 As shown in the figure, the electrode device includes at least one hard conductive piece 1, an electrode wire 2 and at least two electrode assemblies 3, and the adjacent electrode assemblies 3 are electrically connected through the hard conductive piece 1. The hard conductive piece 1 has high structural strength and good connection reliability, can effectively improve the electrical connection strength and reliability between the adjacent electrode assemblies 3, can withstand high-frequency and high-intensity shock wave energy, effectively reduces the risk of electrode wire 2 disintegration and falling off under extreme working conditions, and effectively prolongs the service life of the electrode device as a whole. At the same time, the hard conductive piece 1 is of an integral structure, has few weak points in its own structure compared with the split structure of the electrode wire 2 and the inner electrode, and is conducive to further improving the reliability of the electrical connection between the adjacent electrode assemblies 3 and prolonging the service life of the electrode device.

[0074] Moreover, the at least two electrode assemblies 3 include a distal electrode assembly 31 and a proximal electrode assembly 32, the distal electrode assembly 31 is located at the farthest end of the electrode device, and the proximal electrode assembly 32 is located at the nearest end of the electrode device. The distal electrode assembly 31 is coupled with the power supply through an electrode wire 2, and the proximal electrode assembly 32 is coupled with the power supply through another electrode wire 2. That is, in the electrode device, the adjacent electrode assemblies 3 are electrically connected through the hard conductive piece 1, and the electrode assemblies 3 located at the axial end of the heart valve calcification treatment device are coupled with the external power supply through the electrode wire 2. Compared with the original structure in which the electrode assemblies are electrically connected through the electrode wire 2, the number of electrode wires 2 is reduced, the weak point of electrical connection is correspondingly reduced, and the position of disintegration and falling off of the electrode wire 2 can be further reduced, thereby improving the durability of the electrode device as a whole. In this way, the electrode device in which the hard conductive piece 1 is used to electrically connect the adjacent electrode assemblies 3 can be applied to hard calcification (such as valve calcification indications), can emit shock waves at high frequency and high intensity under extreme working conditions, and has good durability. Compared with the original electrical connection mode through the electrode wire 2, the service life of the electrode device is at least doubled.

[0075] Specifically, the material of the hard conductive piece 1 includes a hard metal, the hard metal includes at least one of steel, titanium alloy, copper alloy, nickel alloy and aluminum alloy, can withstand high-frequency and high-voltage discharge, has high structural strength and good connection reliability, and the service life is effectively prolonged.

[0076] In some example embodiments, the hard conductive piece 1 can be in a sheet structure, for example, a conductive steel sheet, which is good in conductivity, easy to assemble, and high in strength.

[0077] In some example embodiments, the hard conductive piece 1 has a thickness of 0.1 mm to 0.35 mm in the radial direction of the electrode assembly 3. It can be understood that the thickness of the hard conductive piece 1 in the radial direction of the electrode assembly 3 can be any value within the range of 0.1 mm to 0.35 mm. For example, the thickness of the hard conductive piece 1 in the radial direction of the electrode assembly 3 can be 0.1 mm, 0.15 mm, 0.2 mm, 0.25 mm, 0.3 mm, 0.35 mm, etc. Within this thickness range, sufficient structural strength can be provided, the electrode assembly 3 is not prone to disintegration and fracture, the electrical connection reliability is improved, and the discharge stability of the electrode assembly 3 is improved.

[0078] Specifically, as shown in Figure 1 and Figure 2 the distal electrode assembly 31 and the proximal electrode assembly 32 each include a first outer electrode 310, a first insulating layer 311 located inside the first outer electrode 310, and a first inner electrode 312 located inside the first insulating layer 311. The first inner electrode 312 is connected to the electrode wire 2. The first inner electrode 312 and the first outer electrode 310 are isolated by the first insulating layer 311. The first outer electrode 310 and the first insulating layer 311 are provided with at least one first discharge hole 313 that penetrates in the radial direction. The at least one first discharge hole 313 exposes the first inner electrode 312. A first discharge gap is formed between the first outer electrode 310 and the first inner electrode 312 through the first discharge hole 313. The first inner electrode 312 and the first outer electrode 310 discharge only in the area of the first discharge gap. The first insulating layer 311 protrudes axially at both ends in the axial direction of the electrode device beyond the axial end of the first outer electrode 310. This avoids undesired discharge between the first outer electrode 310 and the first inner electrode 312 in an undesired area, greatly improving the discharge effectiveness, discharge strength, and discharge reliability of the entire electrode assembly 3.

[0079] In some example embodiments, as shown in Figure 3 the first inner electrode 312 is connected to the electrode wire 2 in two parts. The end of the electrode wire 2 has an exposed area and the rest of the area is an insulating covered area. The exposed area can be inserted into the first inner electrode 312, and then the first inner electrode 312 is flattened to achieve the connection between the first inner electrode 312 and the electrode wire 2.

[0080] Specifically, as shown in Figure 1As shown, the first outer electrode 310 and the first insulating layer 311 are provided with at least two first discharge holes 313 penetrating in the radial direction, the at least two first discharge holes 313 are respectively located in different regions of the first outer electrode 310 in the circumferential direction of the electrode device, at least one of the at least two first discharge holes 313 exposes the hard conductive member 1, and the region of the hard conductive member 1 exposed to the first discharge hole 313 can be reused as the second inner electrode 11 of the electrode assembly 3; or, the second inner electrodes 11 of two adjacent electrode assemblies 3 are shared, and the second inner electrode 11 is reused as the electrode wire 2 between the two adjacent electrode assemblies 3, which improves the utilization rate of the second inner electrode 11 while improving the electrical connection reliability and prolonging the service life of the electrode device.

[0081] For example, in one specific embodiment, the electrode device includes two electrode assemblies 3, namely a distal electrode assembly 31 and a proximal electrode assembly 32, each of which is provided with a first outer electrode 310, a first insulating layer 311, and a first inner electrode 312, and the first outer electrode 310 and the first insulating layer 311 are provided with two first discharge holes 313 penetrating in the radial direction, one of which exposes the first inner electrode 312 to form a first discharge gap between the first outer electrode 310 and the first inner electrode 312, and the other of which exposes the hard conductive member 1, so that the hard conductive member 1 extends into the inside of the first insulating layer 311 of the distal electrode assembly 31 at one end and extends into the inside of the first insulating layer 311 of the proximal electrode assembly 32 at the other end to achieve electrical connection between the two electrode assemblies 3, while the region of the hard conductive member 1 exposed to the first discharge hole 313 of the distal electrode assembly 31 can be reused as the second inner electrode 11 of the distal electrode assembly 31, and the region of the hard conductive member 1 exposed to the first discharge hole 313 of the proximal electrode assembly 32 can be reused as the second inner electrode 11 of the proximal electrode assembly 32, which improves the electrical connection reliability, prolongs the service life of the electrode device, and improves the utilization rate of the inner electrodes inside the electrode device.

[0082] Specifically, as shown in Figure 1 and Figure 2 The at least two electrode assemblies 3 further include at least one intermediate electrode assembly 33, which is arranged between the distal electrode assembly 31 and the proximal electrode assembly 32 in the axial direction of the electrode device, and the number of the intermediate electrode assembly 33 can be one, two, three, etc., which extends the discharge range of the electrode device to cover a larger treatment area and enables the superposition of shock wave energy between multiple electrode assemblies 3.

[0083] The intermediate electrode assembly 33 includes a second outer electrode 330 and a second insulating layer 331 located inside the second outer electrode 330. The second outer electrode 330 and the second insulating layer 331 have at least one radially penetrating second discharge hole 332. The second discharge hole 332 exposes a rigid conductive member 1. The area of ​​the rigid conductive member 1 exposed to the second discharge hole 332 can be reused as the third inner electrode 12 of the intermediate electrode assembly 33. Alternatively, the third inner electrode 12 of the intermediate electrode assembly 33 is shared with the inner electrode (second inner electrode 11 or adjacent third inner electrode 12) of the adjacent electrode assembly 3. The third inner electrode 12 of the intermediate electrode assembly 33 is reused as the electrode line 2 between the intermediate electrode assembly 33 and the adjacent electrode assembly 3. This improves the reliability of the electrical connection, extends the life of the electrode device, and increases the utilization rate of the third inner electrode 12.

[0084] A second discharge gap is formed between the second outer electrode 330 and the third inner electrode 12 through the second discharge hole 332, so that the discharge between the third inner electrode 12 and the second outer electrode 330 is only within the area of ​​the second discharge gap. The two ends of the second insulating layer 331 in the axial direction of the electrode device protrude axially from the axial ends of the second outer electrode 330 to avoid unwanted discharge between the second outer electrode 330 and the third inner electrode 12 in unwanted areas, which greatly improves the overall discharge effectiveness, discharge intensity and discharge reliability of the intermediate electrode assembly 33. In this way, there is no need to set an additional inner electrode in the intermediate electrode assembly 33, and the discharge function and electrical connection function of the inner electrode can be realized simultaneously by the hard conductive member 1.

[0085] The electrode device (sample A) using the hard conductive component 1 of this invention was subjected to discharge testing with an existing wire-connected internal electrode (sample B). The device was discharged 500 times at an 8kV, 10Hz pulse frequency. Figure 4 As shown, the hard conductive component 1 of sample A was slightly ablated, but the structure was not damaged and it could continue to discharge. However, the inner electrode of sample B was burned through, and the electrode wire 2 fell off, resulting in the inability to discharge normally. This shows that the use of hard conductive component 1 for electrical connection in this invention can effectively extend the service life of the electrode device and has good discharge reliability.

[0086] Specifically, the axial distance between the discharge holes of the two adjacent electrode assemblies 3 is less than or equal to a preset distance, wherein, in the case that the two adjacent electrode assemblies 3 are the distal electrode assembly 31 and the proximal electrode assembly 32, the axial distance refers to the axial distance between the first discharge hole 313 of the distal electrode assembly 31 and the first discharge hole 313 of the proximal electrode assembly 32; in the case that the two adjacent electrode assemblies 3 are two intermediate electrode assemblies 33, the axial distance refers to the axial distance between the second discharge holes 332 of the two adjacent intermediate electrode assemblies 33; in the case that the two adjacent electrode assemblies 3 include the distal electrode assembly 31 or the proximal electrode assembly 32 and one intermediate electrode assembly 33, the axial distance refers to the axial distance between the first discharge hole 313 in the distal electrode assembly 31 or the proximal electrode assembly 32 and the second discharge hole 332 of the adjacent intermediate electrode assembly 33.

[0087] The preset distance is 4.8mm-5.5mm; it can be understood that the preset distance can be any point value in 4.8mm-5.5mm; for example, the preset distance can be 4.8mm, 4.9mm, 5.0mm, 5.1mm, 5.2mm, 5.3mm, 5.4mm, 5.5mm, etc.; within the preset distance range, the axial distance between the two adjacent electrode assemblies 3 is small, a multi-electrode compact series structure is formed in the entire electrode device, which can effectively cause high-intensity energy superposition between the multiple electrode assemblies 3 while extending the shock wave energy coverage range generated by the entire electrode device, thereby improving the treatment effectiveness and efficiency on hard calcification; for example, in some specific embodiments, the preset distance is 5.5mm, i.e., the axial distance between the discharge holes of the two adjacent electrode assemblies 3 is less than or equal to 5.5mm; in other specific embodiments, the preset distance is 5.0mm, i.e., the axial distance between the discharge holes of the two adjacent electrode assemblies 3 is less than or equal to 5.0mm.

[0088] It should be noted that the two adjacent electrode assemblies 3 are electrically connected by the hard conductive piece 1, which can withstand high-frequency and high-intensity shock wave performance and allow the axial distance between the electrode assemblies 3 to be further shortened, thereby improving the arrangement compactness of the electrode assemblies 3 in the electrode device, i.e., the axial distance less than or equal to the preset distance can be achieved on the basis of electrical connection by the hard conductive piece 1, thereby achieving the near distance between the electrode assemblies 3 in the electrode device, high-frequency and high-intensity shock wave force, and the performance of not being easily damaged, so that the electrode device can be suitable for extreme working conditions of hard calcification (valve calcification) and emit long-life, high-frequency, and high-intensity shock waves.

[0089] The peak pressure of the shock wave generated by the electrode device under different axial distances is tested, such as Figure 5As shown, the peak pressure of the shock wave generated when the axial spacing between two adjacent electrode assemblies 3 is 5 mm is obviously higher than that when the axial spacing is 7 mm, and in the compact electrode device formed by three electrode assemblies 3, the axial spacing between the middle electrode assembly 33 and the adjacent two electrode assemblies 3 is 5 mm and 4 mm respectively, and compared with the electrode device composed of double electrode assemblies 3, the peak pressure of the shock wave generated by the electrode device is superimposed 3 more seriously.

[0090] Specifically, in some preferred embodiments, as Figure 6 As shown, the electrode wire 2 includes an outgoing section 21 and a limiting section 22, and the part of the electrode wire 2 exposed outside the first inner electrode 312 is an insulating coated area to prevent abnormal discharge on the electrode wire 2 from damaging the electrode wire 2 and the electrode assembly 3, and correspondingly, the part of the outgoing section 21 and the limiting section 22 exposed outside the first inner electrode 312 is also an insulating coated area, wherein the outgoing section 21 extends from the proximal end of the electrode assembly 3 and specifically from the proximal end of the first inner electrode 312, and the limiting section 22 extends from the distal end of the electrode assembly 3 and specifically from the distal end of the first inner electrode 312; in this way, the electrode wire 2 protrudes towards the distal end, and even after the first inner electrode 312 is ablated, the first outer electrode 310 and the first insulating layer 311 on the distal side of the first discharge hole 313 can still exert a certain extrusion and limitation on the electrode wire 2, preventing the electrode wire 2 from immediately disintegrating and separating from the first inner electrode 312 and causing the electrode assembly 3 to fail.

[0091] The electrode assemblies 3 with the electrode wire 2 protruding at the distal end (sample C) and the electrode assemblies 3 with the electrode wire 2 not protruding (sample B) are subjected to discharge test, and the discharge is performed 500 times at 8 kV and 10 Hz pulse frequency, as Figure 7 As shown, the inner electrode of sample B is burned through, and the electrode wire 2 falls off, which cannot continue to discharge, while the electrode wire 2 of sample C protrudes at the distal end, although the inner electrode is burned through and part of the structure of the electrode wire 2 is impacted by the shock wave energy and protrudes outward from the first discharge hole 313, the electrode wire 2 still does not fall off and can continue to maintain normal discharge, which shows that the electrode wire 2 of the electrode assembly 3 protruding at the distal end can effectively prolong the service life of the electrode wire 2, greatly reduce the risk of disintegration and falling off of the electrode wire 2 under extreme working conditions of high frequency and high intensity, and improve the overall durability of the electrode device.

[0092] In some optional embodiments, the electrode wire 2 connected to the distal electrode assembly 31 can be led out through the inner side of the second insulating layer 331 of the adjacent middle electrode assembly 33 and / or the inner side of the first insulating layer 311 of the adjacent proximal electrode assembly 32; in other optional embodiments, as Figure 6As shown, the electrode wire 2 connected to the distal electrode assembly 31 can be led out through the outside of the second outer electrode 330 of the adjacent middle electrode assembly 33 and / or the outside of the first outer electrode 310 of the adjacent proximal electrode assembly 32, and the arrangement is flexible and does not affect the discharge stability of the electrode device.

[0093] Specifically, as shown in Figure 8 and Figure 9 , the first inner electrode 312 includes an integrated discharge area 3120 and a clamping area 3121, and the first discharge hole 313 exposes at least part of the discharge area 3120, so that the discharge area 3120 forms a first discharge gap with the first outer electrode 310; the clamping area 3121 is connected to the electrode wire 2, and the leading section 21 of the electrode wire 2 extends from the proximal end of the clamping area 3121, and the first discharge hole 313 can be axially extended towards the direction away from the clamping area 3121, so that the first discharge hole 313 is arranged axially offset and away from the clamping area 3121 and the leading section 21 of the electrode wire 2, which can effectively reduce the influence of discharge ablation of the discharge area 3120 on the clamping area 3121, thereby reducing the risk of the electrode wire 2 falling off.

[0094] Optionally, in some exemplary embodiments, a part of the hard conductive member 1 can also be arranged on the first inner electrode 312 to further improve the reliability of the electrical connection on the first inner electrode 312; the first inner electrode 312 has a hard electrical connection area, which is an integrated structure, and the material of the hard electrical connection area includes at least one of steel, titanium alloy, copper alloy, nickel alloy and aluminum alloy, i.e., the hard electrical connection area is the same as the hard conductive member 1, and the hard electrical connection area is located at one end of the first inner electrode 312 away from the clamping area 3121, and the hard electrical connection area forms a first discharge gap with the first outer electrode 310 through the first discharge hole 313.

[0095] Specifically, as shown in Figure 10 , the heart valve calcification treatment device includes a support 5, and the electrode device further includes an inner insulating layer 4 arranged between the inner electrodes of the electrode assembly 3 and the support 5; wherein in the distal electrode assembly 31 and the proximal electrode assembly 32, the inner insulating layer 4 specifically separates the first inner electrode 312 and the support 5, and separates the second inner electrode 11 and the support 5; in the middle electrode assembly 33, the inner insulating layer 4 specifically separates the third inner electrode 12 (i.e., the hard conductive member 1) and the support 5; in this way, the inner insulating layer 4 can form an effective insulating separation between the electrode assembly 3 and the support 5, so as to avoid the support 5 from damaging the service life of the electrode device by breakdown discharge.

[0096] Specifically, as shown in Figure 11As shown, the electrode device further comprises an insulating coating layer 6, which at least partially covers the electrode assembly 3 and exposes the discharge gap of the electrode assembly 3, specifically exposes the first discharge gap and the second discharge gap, and fills between two adjacent electrode assemblies 3, that is, the insulating coating layer 6 covers all structures of the electrode device except the first discharge hole 313 and the second discharge hole 332. The insulating coating layer 6 can be formed by glue filling or the like, can relieve impact, effectively limit abnormal discharge of non-discharge area, avoid false breakdown under high voltage load, at the same time improve the overall structural firmness of the electrode device, reduce the risk of displacement of each component in the electrode device under high-frequency high-intensity shock wave, and can greatly improve the discharge stability and durability.

[0097] In addition, in some preferred embodiments, the insulating coating layer 6 can also be used to seal and fix the limiting section 22 of the electrode wire 2, thereby further improving the limiting effect on the electrode wire 2, preventing the electrode wire 2 from disintegrating and falling off, thereby prolonging the service life of the electrode device.

[0098] As shown in the left side of the figure, Figure 12 the electrode device structure with the insulating coating layer 6, and the right side is the electrode device structure without the insulating coating layer 6 in the prior art. Under the condition of 8kV, 10Hz pulse frequency and 500 times of discharge, it can be seen that the part with the insulating coating layer 6 is still structurally stable, while the part without the insulating coating layer 6 has structural disintegration due to mechanical, high temperature and other factors, which shows that the insulating coating layer 6 can effectively improve the structural stability and service life of the electrode device.

[0099] On the other hand, as shown in Figure 13 , Figure 14 , Figure 15 and Figure 16 , the present application further provides an impact wave device comprising the electrode device as described above. In an impact wave device, at least one electrode device can be included to meet the treatment needs in different scenarios, so that the impact wave device can withstand high-frequency high-energy shock waves for a long service life.

[0100] Specifically, in some exemplary embodiments, the impact wave device further comprises an inner tube 7, an inflatable component 8 connected to part of the inner tube 7, and a support 5 connected to the inner tube 7 at the distal end, and the electrode device is arranged in the inner tube 7. Figure 17The electrode device shown in the drawings is arranged on the support 5, wherein the inflatable component 8 has a receiving cavity 81 inside, and the support 5 is at least partially located in the receiving cavity 81, and the radial distance between the electrode device and the inflatable component 8 is constant in the working state. In this way, by reasonably arranging the position of the support 5, the electrode device can be relatively close to the inflatable component 8, reducing the attenuation of the shock wave energy released by the electrode device when propagating, improving the treatment effectiveness on the treatment area, and avoiding the electrode device being too close to the edge wall of the inflatable component to break the inflatable component, improving the service life and operation stability of the shock wave device, and improving the treatment efficiency, treatment effectiveness, treatment stability and treatment safety.

[0101] As shown in Figure 17 and Figure 20 , the shock wave device can also be applied to treat the calcification of tissues such as blood vessels and heart valves, that is, the shock wave device can include at least one of a heart valve calcification treatment device and an intravascular calcification treatment device.

[0102] Specifically, in some exemplary embodiments, the support 5 is a deformable support 51 capable of adjusting the distance from the inner wall of the inflatable component 8 by deformation, and the deformable support 51 is capable of moving in coordination with the electrode device by deformation, so that the deformable support 51 is folded and close to the inner tube 7 or arched and away from the inner tube 7 in coordination with the electrode device; on the one hand, during the intervention of the shock wave device, the inflatable component 8 is in a rolled and contracted state, so that the circumferential size of the entire shock wave device including the deformable support 51, the electrode device and its pins is reduced, which is beneficial to the passage of the shock wave device, improves the passability and effectiveness and stability of reaching the treatment area, and facilitates subsequent precise and effective treatment, especially can meet the high requirements for size in the scenarios of vascular intervention and heart valve intervention; on the other hand, after the inflatable component 8 of the shock wave device reaches the treatment area, the inflatable component 8 can expand, and in the expanded state of the inflatable component 8, the deformable support 51 loses the pressure applied by the rolling of the inflatable component 8, and can arch and drive the electrode device close to the edge wall of the inflatable component 8, thereby shortening the radial distance between the electrode device and the inner wall of the inflatable component 8, that is, the electrode device is closer to the treatment area, which reduces the energy attenuation of the shock wave energy generated by the electrode device when reaching the treatment area, and effectively improves the treatment efficiency and treatment effect; it should be noted that in the arched state of the deformable support 51, the radial distance between the electrode device and the inflatable component 8 in the working state of the shock wave device is constant, so as to avoid the situation that the deformable support 51 in the inflatable component 8 at the distal end is biased to one side due to the limitation of the bending blood vessel direction of the proximal end during the access of the blood vessel, effectively preventing the deformable support 51 in coordination with the electrode device from contacting the inner wall of the inflatable component 8 and damaging the inflatable component 8 during discharge, improving the treatment stability, reliability and safety, and also being beneficial to prolonging the service life of the shock wave device.

[0103] In some exemplary embodiments, the inner tube 7 is a bendable tube, which can freely adjust the bending direction and degree of the inner tube 7 during the intervention of the shock wave device, so as to facilitate the flexible adjustment of the shock wave device in the human body, improve the passability of the shock wave device, and adjust the position of the inflatable component 8 in the heart valve or blood vessel according to the treatment area, thereby improving the effectiveness and accuracy of the inflatable component 8 of the shock wave device reaching the treatment area, and further improving the treatment efficiency and treatment safety.

[0104] Specifically, in some exemplary embodiments, the shock wave device includes a single inflatable component 8, such as Figure 17As shown, the inflatable component 8 is sleeved on the inner tube 7, and a containing cavity 81 can be formed between the inflatable component 8 and the inner tube 7. During the intervention of the shock wave device, the inflatable component 8 is in a winding and shrinking state, at this time, the containing cavity 81 has almost no volume, and the pressure of the winding and shrinking of the inflatable component 8 can make the deformable support 51 in a folding state or a winding and folding state, and the deformable support 51 is close to the inner tube 7. After the inflatable component 8 reaches the treatment area, the inflatable component 8 can be filled with liquid medium, so that the inflatable component 8 expands to an expanded state, and the volume of the containing cavity 81 is increased. At this time, the inflatable component 8 is released, and the containing cavity 81 can reserve space for the subsequent arching of the deformable support 51, and the effectiveness of the arching of the deformable support 51 is improved.

[0105] Specifically, as shown in Figure 17 , the shock wave device further comprises an outer tube 9 sleeved on the inner tube 7, the inner diameter of the outer tube 9 is greater than the outer diameter of the inner tube 7, and the outer tube 9 and the inner tube 7 have a first gap 91. The distal end of the outer tube 9 is connected to the proximal end of the inflatable component 8, and the first gap 91 is in communication with the containing cavity 81, so that the liquid medium is introduced into the containing cavity 81 through the first gap 91 between the outer tube 9 and the inner tube 7, and the electrode device generates shock wave energy through the liquid-electric effect. Wherein, the outer tube 9 can also be an adjustable bending pipe, which can be bent together with the inner tube 7, has good flexibility, and can adjust the position of the inflatable component 8 in the heart valve or blood vessel according to the treatment area, thereby improving the efficiency and accuracy of the inflatable component 8 of the shock wave device reaching the treatment area.

[0106] Specifically, in some exemplary embodiments, as shown in Figure 14 and Figure 15 , the outer tube 9 comprises a plurality of first gaps 91, and each first gap 91 is used for the proximal end of the deformable support 51 to extend into, so as to provide the containing cavity 81 with a liquid channel and an electrical circuit channel. Further, in some exemplary embodiments, as shown in Figure 16 , the shock wave device comprises a plurality of inflatable components 8, and each electrode device is built in the containing cavity 81 of each inflatable component 8. The end of the inflatable component 8 and the end of the deformable support 51 extend into each first gap 91, so as to fix the inflatable component 8 through the first gap 91 and provide the inflatable component 8 with a liquid channel and an electrical circuit channel.

[0107] Specifically, in some exemplary embodiments, as shown in Figure 14 and Figure 15 , the outer tube 9 further comprises a second gap 93, and the second gap 93 is connected with the inner tube 7, so that the proximal end of the inner tube 7 can extend into the second gap 93 to provide a liquid channel through the second gap 93. Further, in some exemplary embodiments, as shown in Figure 16As shown, the second gap 93 is also provided with an inflatable component 8, which is not provided with an electrode device inside, but serves as a guide wire accommodating channel and provides a liquid channel.

[0108] For example, as Figures 14-16 shown, in one specific embodiment, the outer tube 9 includes one second gap 93 and three circumferentially arranged first gaps 91, each of which is fixed with an inflatable component 8, each of which is provided with an electrode device and provides a liquid channel and an electrical circuit channel for the accommodating cavity 81 inside the inflatable component 8; while the second gap 93 is fixed with an inflatable component 8, which is not provided with an electrode device, which is used as a guide wire accommodating channel and provides a liquid channel, so as to effectively realize the release of high-intensity high-frequency shock waves in the working state, with good stability.

[0109] Specifically, in some optional embodiments, the shock wave device includes one deformable support 51; in some preferred embodiments, as Figure 18 and Figure 22 shown, the shock wave device includes a plurality of deformable supports 51, and the shock wave device can include two, three, four, five, etc. deformable supports 51, wherein the plurality of deformable supports 51 are arranged in the accommodating cavity 81 along the circumference of the inner tube 7, which is beneficial to enhance the intensity of the shock wave energy released by the shock wave device; in some specific embodiments, as Figures 17-20 shown, the shock wave device can include three deformable supports 51; in other specific embodiments, as Figures 20-24 shown, the shock wave device can include two deformable supports 51.

[0110] Specifically, as Figure 19 and Figure 23 shown, the plurality of deformable supports 51 are arranged in the accommodating cavity 81 along the circumference of the inner tube 7 at equal intervals, which improves the uniformity of the shock wave released by the electrode device in the arched state of the deformable support 51.

[0111] Preferably, the shock wave device includes a plurality of circumferentially arranged deformable supports 51, each of which is provided with an electrode device, so that the shock wave release can cover all directions of the inflatable component 8, expand the coverage area of the shock wave energy, and improve the treatment efficiency and treatment effect.

[0112] Among them, as Figure 20 and Figure 24As shown, the circumferential cross section of the inflatable member 8 can be a regular shape such as a circle, or an irregular shape such as a gourd shape, a petal shape, an oval shape, a circumferential protrusion, etc. The present application does not make specific limitations on this, and the shape of the inflatable member 8 capable of converting between the wound and contracted state and the expanded state and capable of reserving a certain accommodation cavity 81 in the expanded state can all be within the protection scope of the present application. For example, Figure 20 In a), the circumferential cross section of the inflatable member 8 is a circle; in Figure 20 b) and Figure 20 c), the circumferential cross section of the inflatable member 8 is a relatively narrow petal shape and a relatively wide petal shape, respectively. In addition, it needs to be explained that when the inflatable member 8 is in the wound and contracted state, the circumferential cross section of the circumscribed shape composed of the deformable support 51, the electrode device and the inner tube 7 is smaller than the inner wall circumference of the tube pin at the proximal end of the inflatable member 8, so that the circumferential cross-sectional area of the inflatable member 8 as a whole in the wound and contracted state is smaller, thereby improving the passability of the inflatable member 8 during the intervention process.

[0113] Specifically, in some other exemplary embodiments, as shown in Figure 25 , Figure 26 , Figure 27 and Figure 28 , the shock wave device includes a plurality of inflatable members 8, which are circumferentially arranged on the outer side of the inner tube 7, and the proximal end of each of the plurality of inflatable members 8 can extend into a first gap 91, which provides a liquid passage and an electrical circuit passage for each inflatable member 8. Wherein, the support 5 can be a rigid support or a deformable support 51, and the distal end of the support 5 can axially protrude the inflatable member 8 so as to be fixed to the distal end of the inner tube 7.

[0114] Specifically, in the case that the circumferential section of the inflatable component 8 is a special-shaped, the circumscribed circle diameter of the inflatable component 8 is 8mm-28mm, which refers to the circumscribed circle diameter of the inflatable component 8 in the expanded state when the shape of the inflatable component 8 is irregular; in addition, in the case that the circumferential section of the inflatable component 8 is a circular shape of silicon germanium, the diameter of the inflatable component 8 is 8mm-28mm, which refers to the diameter of the inflatable component 8 in the expanded state when the cross-sectional shape of the inflatable component 8 is circular; it can be understood that the diameter or the circumscribed circle diameter of the inflatable component 8 can be any point value in 8mm-28mm; for example, the diameter or the circumscribed circle diameter of the inflatable component 8 can be 8mm, 10mm, 12mm, 15mm, 18mm, 20mm, 22mm, 24mm, 25mm, 28mm, etc.; within the range of the diameter or the circumscribed circle diameter, a certain volume of the accommodation cavity 81 can be reserved for the arching of the deformable support 51, which is convenient for reaching the treatment area during the intervention process, and the distance between the electrode device and the edge wall of the inflatable component 8 is relatively small, which reduces the attenuation of the shock wave energy released by the electrode device when reaching the treatment area, and improves the treatment efficiency.

[0115] In the case that the shock wave device includes a single inflatable component 8, the diameter or the circumscribed circle diameter of the single inflatable component 8 is 18mm-28mm; in the case that the shock wave device includes multiple inflatable components 8, the diameter or the circumscribed circle diameter of each inflatable component 8 in the multiple inflatable components 8 is 8mm-12mm, in order to meet the requirements of different shock wave devices and improve the treatment effectiveness and safety.

[0116] Specifically, the wall thickness of the inflatable component 8 is greater than or equal to a preset wall thickness, which is 0.05mm-0.07mm; it can be understood that the preset wall thickness can be any point value in 0.05mm-0.07mm; for example, the preset wall thickness can be 0.05mm, 0.055mm, 0.06mm, 0.065mm, 0.07mm, etc., the wall thickness of the inflatable component 8 is relatively thick, which can provide a larger binding force to effectively cover the electrode device and the deformable support 51 on the inner tube 7 in the coiled and contracted state, reduce the cross-sectional area of the shock wave device during the intervention process, and improve the passability; for example, in one specific embodiment, the preset wall thickness is 0.05mm, i.e., the wall thickness of the inflatable component 8 is greater than or equal to 0.05mm; in another specific embodiment, the preset wall thickness is 0.065mm, i.e., the wall thickness of the inflatable component 8 is greater than or equal to 0.065mm.

[0117] Specifically, the deformable support 51 can be a pre-shaped support made of a metal material with a memory function, that is, the shape of the deformable support 51 after shaping is the shape in the arched state, and after shaping, it is in a relatively soft state, and can be deformed to reach the collapsed state under the action of external force, facilitating the compression of the electrode device with the deformable support 51 in the expandable component 8 and the overall retreat of the shock wave device, but in the case of losing external force, it can recover to the arched state, and can effectively cooperate with the movement of the electrode device to make the electrode device play different roles in different working processes. When collapsed and close to the inner tube 7, it can facilitate the intervention of the shock wave device, or when arched and away from the inner tube 7 (i.e. close to the edge wall of the expandable component 8), it can facilitate the reduction of the energy attenuation of the shock wave released by the electrode device to the treatment area, and improve the treatment efficiency and treatment stability.

[0118] In some embodiments, the material of the deformable support 51 includes nickel-titanium alloy, by adjusting the content of nickel in the nickel-titanium alloy, the AF point of the deformable support 51 can be adjusted, and at the same time, by using a certain heat treatment temperature and heat treatment time, the phase transition temperature and microstructure of the nickel-titanium alloy can be changed, and the AF point of the deformable support 51 can be further adjusted to improve the performance of the nickel-titanium alloy and meet the application requirements in the shock wave device.

[0119] Specifically, the radial distance between the electrode device and the inner tube 7 in the arched state of the deformable support 51 is greater than the radial distance between the electrode device and the inner tube 7 in the collapsed state of the deformable support 51, so that the electrode device is close to the edge wall of the expandable component 8 when the deformable support 51 is deformed and arched, shortens the distance between the electrode device and the treatment area, reduces the attenuation of the shock wave energy generated by the electrode device when reaching the treatment area, and improves the treatment efficiency and treatment reliability.

[0120] Specifically, as shown in FIG. 6, the deformable support 51 is in the arched state, and the electrode device is close to the edge wall of the expandable component 8, so that the distance between the electrode device and the treatment area is shortened, and the attenuation of the shock wave energy generated by the electrode device when reaching the treatment area is reduced, thereby improving the treatment efficiency and treatment reliability. Figure 29As shown, the deformable support 51 comprises a support portion 52, a bending portion 53 and a connecting portion 54, and the electrode device is located on at least one of the support portion 52 and the bending portion 53; in the case that the electrode device is located on the support portion 52, the support portion 52 can be arched to cooperate with the electrode device to be close to the edge wall of the inflatable component 8, so as to reduce the attenuation when the electrode device releases the shock wave energy; and in the case that the electrode device is located on the bending portion 53, the bending portion 53 has a certain angle between the axial direction of the inner tube 7, so that the electrode device can emit the shock wave energy obliquely, and generate the shock wave force in the axial direction, which is beneficial to widen the passage of the shock wave device and improve the passability of the shock wave device when the shock wave device encounters a narrow intervention position; one end of the support portion 52 is connected with one end of the bending portion 53, and the other end of the bending portion 53 is connected with the connecting portion 54; similarly, the other end of the support portion 52 is connected with one end of the other bending portion 53, and the other end of the other bending portion 53 is connected with the other connecting portion 54; and the two connecting portions 54 are respectively connected with the inner tube 7, so that the deformable support 51 is connected with the inner tube 7.

[0121] As shown, Figure 29 in the arched state of the deformable support 51, the radial distance between the support portion 52 and the inner tube 7 is greater than the radial distance between the connecting portion 54 and the inner tube 7, and in the axial direction away from the support portion 52, the bending portion 53 gradually bends towards the inner tube 7, that is, the deformable support 51 gradually moves away from the inner tube 7 from the connecting portion 54 to the support portion 52, and is close to the edge wall of the inflatable component 8, so as to reduce the attenuation when the electrode device generates the shock wave energy; in some optional embodiments, the shape of the deformable support 51 can be trapezoidal, arcuate, arc-shaped, irregular and the like, and the present application does not make specific limitation thereon, and the shape of the deformable support 51 in the arched state towards the edge wall of the inflatable component 8 can be within the protection scope of the present application.

[0122] Specifically, in the arched state of the deformable support 51, or in the case that the support 5 is a hard support 5, the radial distance between the electrode device and the inner wall of the inflatable component 8 is 1mm-4mm; it can be understood that the radial distance between the electrode device and the inner wall of the inflatable component 8 can be any point value in the range of 1mm-4mm; for example, the radial distance between the electrode device and the inner wall of the inflatable component 8 can be 1mm, 1.5mm, 2mm, 2.5mm, 3mm, 3.5mm, 4mm and the like; in this way, the radial distance between the electrode device and the edge wall of the inflatable component 8 is small, which can effectively reduce the energy attenuation of the shock wave energy reaching the treatment area, and improve the treatment efficiency and treatment reliability; in some preferred embodiments, the radial distance between the electrode device and the inner wall of the inflatable component 8 is 1mm-4mm.

[0123] Specifically, the height A of the arching of the support part 52 of the deformable support 51 is determined based on the size of the inflatable member 8; assuming the diameter of the inflatable member 8 is D, the height A of the arching of the deformable support 51 satisfies the following formula:

[0124]

[0125] That is, the difference between the radius of the inflatable member 8 and the arching height of the deformable support 51 is 1mm-4mm.

[0126] In some preferred embodiments, the height A of the arching of the deformable support 51 satisfies the following formula:

[0127]

[0128] That is, the difference between the radius of the inflatable member 8 and the arching height of the deformable support 51 is 1mm-3mm.

[0129] Specifically, in some exemplary embodiments, the support 5 comprises a limiting part 55 which, in the arching state, abuts against the inner wall of the inflatable member 8 on the outer side in the radial direction, and the electrode device is located between two adjacent limiting parts 55 in the axial direction, which is good in balance. The limiting part 55 has a certain width in the radial direction, and when the deformable support 51 is arched to the limit position or the rigid support 5 is in contact with the limiting part 55 and the inner wall of the inflatable member 8, the electrode device and the inflatable member 8 can always maintain a constant distance therebetween, avoiding contact between the electrode device and the side wall of the inflatable member 8, thereby preventing the inflatable member 8 from being broken in the subsequent discharge process. Further, the limiting part 55 is close to the electrode device in the axial direction, which can improve the anti-deformation ability of the deformable support 51 on the side of the electrode device under the condition of being pressed by the inflatable member 8 or subjected to non-desired external forces such as proximal bending force, thereby further helping to maintain the constant radial distance between the electrode device and the inner wall of the inflatable member 8, greatly improving the treatment effectiveness and safety.

[0130] In addition, when the support 5 is the deformable support 51, even if the proximal end of the shock wave device is limited by the bending of the blood vessel, part of the deformable support 51 may be bent, but limited by the pressure between the limiting part 55 and the inner wall of the inflatable member 8, the limiting part 55 will only displace in the circumferential direction, and the radial distance between the position of the electrode device and the side wall of the inflatable member 8 will not change, thereby effectively maintaining the constant distance between the electrode device and the inner wall of the inflatable member 8, greatly improving the discharge stability, reliability and safety.

[0131] Exemplarily, as shown in Figure 25 and Figure 30As shown, the limiting portion 55 can be a spacer block arranged on the support portion 52, which has a certain width in the radial direction and can abut against the inner wall of the inflatable member 8, and the width of the electrode device in the radial direction is smaller than the radial width of the spacer block, so that a certain space is always left between the electrode device and the inner wall of the inflatable member 8, preventing the electrode device from directly contacting the inner wall of the inflatable member 8 and breaking the inflatable member 8 during the discharge process, greatly improving the treatment stability and treatment safety, and prolonging the service life of the shock wave device.

[0132] Specifically, in some optional embodiments, as shown in Figure 31 As shown, the limiting portion 55 is the bending portion 53, and in the arched state of the deformable support 51, the bending portion 53 is attached to or parallel with the inner wall of the tapered section of the inflatable member 8, so that the inner wall of the tapered section of the inflatable member 8 limits the bending portion 53, and even if the proximal end is bent due to the pressure of the blood vessel during the intervention process, the support portion 52 between the two bending portions 53 is not easily affected, that is, the radial distance between the electrode device arranged on the support portion 52 and the inner wall of the inflatable member 8 can still be effectively kept constant; and the length of the bending portion 53 in the axial direction of the inner tube 7 is smaller than the length of the tapered section of the inflatable member 8 in the axial direction of the inner tube 7, and similarly, the width of the bending portion 53 in the radial direction of the inner tube 7 is also smaller than the width of the tapered section of the inflatable member 8 in the radial direction of the inner tube 7, so that the maximum arching height of the support portion 52 is always smaller than the arching height of the middle part of the inflatable member 8, avoiding the contact between the electrode device arranged on the support portion 52 and the inner wall of the inflatable member 8, greatly reducing the risk of breaking the inflatable member 8 during the discharge process, improving the discharge stability and discharge safety, and prolonging the service life of the shock wave device.

[0133] Specifically, in some optional embodiments, as shown in Figure 27 and Figure 32 As shown, the limiting portion 55 is located between the support portion 52 and the bending portion 53, and the end of the limiting portion 55 connected to the support portion 52 is recessed in the radial direction of the inner tube 7, so that the position of the limiting portion 55 farthest from the inner tube 7 in the radial direction can contact the inner wall of the inflatable member 8, effectively limiting the radial position of the support portion 52 between the two limiting portions 55 to be constant, and the limiting portion 55 gradually recesses inwardly to the support portion 52, increasing the radial distance between the support portion 52 and the inner wall of the inflatable member 8, so that the electrode device arranged on the support portion 52 can have a certain radial distance from the inner wall of the inflatable member 8 and maintain the radial distance constant, preventing the proximal end from bending and driving the deformable support 51 and the electrode device to contact the inner wall of the inflatable member 8, greatly prolonging the service life of the inflatable member 8 and improving the stability, reliability and safety of the treatment during the discharge process.

[0134] Specifically, in other optional embodiments, as shown in Figure 33 In the case that the expandable component 8 is a profiled expandable component, the profiled expandable component includes the abutting portion 82 and the protruding portion 83, wherein the protruding portion 83 is located between two adjacent abutting portions 82 in the axial direction of the inner tube 7, and the radial distance between the inner wall of the protruding portion 83 and the inner tube 7 is greater than the radial distance between the abutting portion 82 and the inner tube 7 in the expanded state of the expandable component 8, the abutting portion 82 is used to abut against the limiting portion 55 to define the position of the electrode device on the deformable support 51, and the protruding portion 83 is used to expand the radial distance between the inner wall of the expandable component 8 and the electrode device to further avoid the contact between the electrode device and the inner wall of the expandable component 8.

[0135] Optionally, in the profiled expandable component, the limiting portion 55 can be a spacer as shown in Figure 30 , or can be a concave structure as shown in Figure 32 ; in addition, as shown in Figure 33 , the limiting portion 55 can also be located on the end portion of the support portion 52 connected with the bending portion 53, through which the limiting portion 55 can contact and abut against the inner wall of the abutting portion 82 in the arched state of the deformable support 51, and cooperate with the protruding portion 83 protruding radially away from the inner tube 7 to limit the electrode device between the two limiting portions 55 from contacting the expandable component 8 and maintain the constant radial distance therebetween, with good limiting reliability.

[0136] Specifically, as shown in Figure 34 , in some exemplary embodiments, the two ends of the deformable support 51 in the axial direction are fixedly connected with the inner tube 7, which can be fixed by welding, bonding or the like; during assembly, one deformable support 51 can be assembled by fixing the two ends thereof to the inner tube 7, and the above steps can be repeated to assemble multiple deformable supports 51, and finally the expandable component 8 is sleeved to form the shock wave device, which is simple and convenient to assemble and fixedly reliable.

[0137] Specifically, as shown in Figure 35 , in other exemplary embodiments, in the case that the shock wave device includes multiple deformable supports 51, at least two deformable supports 51 among the multiple deformable supports 51 are in an integrated structure, the two deformable supports 51 are connected to each other in an integrated manner at one end of the distal end of the inner tube 7 and are fixedly connected with the inner tube 7, and the deformable supports 51 at one end of the proximal end of the inner tube 7 are respectively fixedly connected with the inner tube 7; during assembly, the two deformable supports 51 can be assembled as a group to greatly improve the assembly efficiency; as shown in Figure 36As shown, in other exemplary embodiments, the two deformable supports 51 are connected to each other at one end of the distal end of the inner tube 7, and the two deformable supports 51 are also connected to each other at one end of the proximal end of the inner tube 7, further improving assembly convenience; and the two deformable supports 51 at the end are offset relative to the outer wall of the inner tube 7 to effectively avoid the inner tube 7.

[0138] In addition, in other optional embodiments, the deformable support 51 at one end of the proximal end of the inner tube 7 can be connected to the inner tube 7 relative to the inner tube 7, so that the proximal end of the deformable support 51 can reciprocate along the inner tube 7 in the axial direction, change the shape of the deformable support 51, and can be stepless deformation between the arching state and the folding state.

[0139] Specifically, in some exemplary embodiments, as shown in Figure 17 and Figure 21 , the shock wave device includes a first connecting piece 84 connected to the distal end of the inner tube 7, and the distal end of the deformable support 51 is connected to the inner tube 7 through the first connecting piece 84; in other exemplary embodiments, as shown in Figure 17 and Figure 21 , the shock wave device includes a second connecting piece 85 connected to the proximal end of the inner tube 7, and the proximal end of the deformable support 51 is connected to the inner tube 7 through the second connecting piece 85; in some preferred embodiments, the shock wave device includes a first connecting piece 84 and a second connecting piece 85, the first connecting piece 84 is connected to the distal end of the inner tube 7, and the second connecting piece 85 is connected to the proximal end of the inner tube 7, and the end of the deformable support 51 is connected to the inner tube 7 through the first connecting piece 84 and the second connecting piece 85; wherein the first connecting piece 84 and the second connecting piece 85 can include at least one of a heat shrink tube, an injection molding part, and other connecting parts, to realize the assembly between the deformable support 51 and the inner tube 7, and improve the connection effectiveness and stability.

[0140] Specifically, as shown in Figure 17 and Figure 21 , in some exemplary embodiments, the first connecting piece 84 and the second connecting piece 85 are respectively fixedly connected to the inner tube 7, in the case that the inflatable component 8 is in the winding and shrinking state, the deformable support 51 is folded on the surface of the inner tube 7 under the pressure of the winding of the inflatable component 8, and after the inflatable component 8 is expanded, the deformable support 51 which loses the external force limitation can restore the original shape, especially the support part 52 can cooperate with the electrode device to approach the edge wall of the expanded inflatable component 8, reduce the energy attenuation of the shock wave generated by the electrode device when reaching the treatment area, improve the intensity of the shock wave energy acting on the treatment area, and improve the treatment efficiency.

[0141] Specifically, as shown in Figure 37As shown, in some other exemplary embodiments, the first connector 84 is fixedly connected to the inner tube 7 to fix the distal end of the deformable support 51 to the distal end of the inner tube 7; while the second connector 85 is movably connected to the inner tube 7, and the second connector 85 can reciprocate along the axial direction of the inner tube 7 under the action of external force, so that the proximal end of the deformable support 51 is in a movable state, causing the deformable support 51 to retract or arch; then, in the arched state, the axial length decreases and the radial height increases, especially the radial height of the support portion 52 increases. The coordinating electrode device is located close to the sidewall of the expandable component 8 to reduce energy attenuation, enhance the intensity of the shock wave energy acting on the treatment area, and improve treatment efficiency. During the deformation process towards the contracted state, the deformable support 51 is relatively soft, the axial length of the deformable support 51 increases, or even straightens completely, and part of the structure of the deformable support 51 can extend into the first gap 91 of the outer tube 9. At the same time, the radial height decreases, and the coordinating electrode device is located close to the inner tube 7 so that the shock wave device can be smoothly intervened or withdrawn when the treatment is completed.

[0142] Specifically, such as Figure 38 As shown, in some other exemplary embodiments, the first connector 84 is movably connected to the inner tube 7, and the second connector 85 is movably connected to the inner tube 7. This means that both ends of the deformable support 51 are movable, and the deformable support 51 itself has a pre-shaping force capable of maintaining its current shape without deformation. In other words, the deformable support 51 itself has a certain supporting strength. With both ends movable, when either the first connector 84 or the second connector 85 is subjected to force, it will preferentially drive the entire deformable support 51 to move, thereby enabling the entire deformable support 51 and the electrode assembly to move under external force. The device reciprocates along the axial direction of the inner tube 7, allowing the deformable support 51, along with the electrode device, to be contained within the first gap 91 of the outer tube 9 during the non-shock wave release phase. This significantly reduces the radial height of the deformable support 51 in the contained state, facilitating a reduction in the overall circumferential area of ​​the expandable component 8 for easier intervention or retraction. Conversely, it also allows the deformable support 51 to be easily pushed out of the first gap 91 of the outer tube 9 into the accommodating cavity 81, effectively arching up without external force to help the electrode device approach the sidewall of the expandable component 8, shortening the radial distance between the electrode device and the sidewall of the expandable component 8, and improving treatment efficiency.

[0143] In some exemplary embodiments, the movable connection may employ a sliding connection, wherein, for example... Figure 39As shown, the first connecting member 84 and / or the second connecting member 85 can be a ring structure, the end of the deformable support 51 can be fixed to the inner wall of the ring structure or to the outer wall of the ring structure, or can axially penetrate the ring structure, which is simple to assemble and low in cost, and facilitates the end of the deformable support 51 to axially slide along the inner tube 7 with the first connecting member 84 and / or the second connecting member 85, which is high in sliding convenience and not easy to jam.

[0144] Optionally, in some example embodiments, as shown in Figure 40 As shown, the cross-sectional area of the ring structure is smaller than that of the first gap 91, so that the liquid medium is not blocked during injection into the inflatable component 8; and the outer tube 9 is provided with a ring guide 92 on the inner wall, which is located in the pin region near the end of the inflatable component 8. The ring structure and the ring guide 92 are both hard and not easy to deform, so that the ring structure can axially slide along the ring guide 92 with the liquid medium when the inflatable component 8 is filled or depressurized, to realize the forward movement or retreat of the deformable support 51.

[0145] Specifically, as shown in Figure 37 and Figure 38 In some example embodiments, the second connecting member 85 is movably connected with the inner tube 7, and the shock wave device further comprises a push-pull member 86, one end of which is fixedly connected with the second connecting member 85, for applying an external force to the second connecting member 85 to drive the second connecting member 85 to reciprocatingly move along the axial direction of the inner tube 7. When the push-pull member 86 applies a pushing force to the second connecting member 85, the second connecting member 85 can be pushed into the accommodating cavity 81 of the inflatable component 8 together with the deformable support 51, at this time, the deformable support 51 will not be subjected to the pressure applied by the inner wall of the outer tube 9, and the inflatable component 8 in the expanded state will not generate pressure on the deformable support 51, and the proximal end of the deformable support 51 will gradually arch during the movement towards the distal end of the inner tube 7, and the electrode device will be close to the side wall of the inflatable component 8, to effectively reduce the attenuation of the shock wave energy. Conversely, when the push-pull member 86 applies a pulling force to the second connecting member 85, the proximal end of the deformable support 51 can be straightened together with the second connecting member 85, that is, the deformable support 51 will gradually retract and approach the inner tube 7, and the proximal end of the deformable support 51 can be pulled into the first gap 91 between the outer tube 9 and the inner tube 7, or even the deformable support 51 together with the electrode device can be pulled into the first gap 91 to be retracted, and the deformable support 51 will be deformed due to at least one of the pressure of the outer tube 9 and the pulling force of the push-pull member 86, and will gradually retract on the inner tube 7. The push-pull member 86 is convenient to operate as a whole and has high control precision; in some preferred embodiments, the push-pull member 86 can be a metal wire, which is convenient to assemble, accurate to control and low in cost.

[0146] Furthermore, in some exemplary embodiments, the shock wave device also includes an operating handle, with the other end of the push-pull member 86 connected to the operating handle. The operating handle allows the push-pull member 86 to pull or push out the second connecting member 85 and the deformable support member 51, making control convenient and quick. The stroke of the second connecting member 85 is precisely controllable. Exemplarily, in some specific embodiments, the operating handle may include an adjustment knob. By rotating the adjustment knob, the length of the push-pull member 86 in the axial direction of the inner tube 7 can be adjusted, thereby realizing the pulling or pushing out of the second connecting member 85.

[0147] Specifically, the operating handle has an axially movable threaded tube inside, and the proximal end of the push-pull member 86 extends axially through the outer tube 9 and connects to the threaded tube; the adjusting knob is a threaded rotating member and is nested on the outside of the threaded tube, so that rotating the adjusting knob can drive the threaded tube to move, thereby pulling or pushing the deformable support member 51 to move; for example, the push-pull member 86 can be a metal wire, which can achieve a pulling force towards the proximal end; as another example, when the push-pull member 86 is a hollow tube, it has a certain supporting strength and can achieve the external force required for reciprocating push and pull.

[0148] In some alternative embodiments, a sealing ring is provided at the proximal end of the outer tube 9 and is located at the position where the push-pull member 86 protrudes from the outer tube 9. The sealing ring is fitted onto the push-pull member 86 and is interference-fitted with the push-pull member 86 to prevent leakage of liquid medium, improve the durability and safety of the shock wave device, and also improve the stability and safety of the treatment process.

[0149] The following test was conducted using the shock wave device provided in the embodiments of the present invention.

[0150] First, under different arch heights (A), the peak shock wave pressure at a point 24 mm from the center of the inner tube 7 was measured. Figure 41 As shown, under the same conditions, the greater the arch height A, the closer the electrode device is to the side wall of the expandable component 8, and the greater the detected peak pressure of the shock wave. This indicates that the shock wave device provided in this embodiment of the invention can effectively reduce the energy attenuation when reaching the detection point or the treatment area when the electrode device is close to the side wall of the expandable component 8, and the shock wave energy reaching the treatment area can be effectively enhanced, thereby improving treatment efficiency and treatment reliability.

[0151] Secondly, the operating status of the shock wave device was tested at different pulse frequencies; among them, such as Figure 42 As shown, when shock waves are continuously released at 1Hz, 10Hz, and 20Hz, the sound pressure energy is almost always between 2MPa and 3MPa. The difference in sound pressure energy at different operating frequencies is small, or even almost non-existent, indicating that the shock wave device provided in this embodiment of the invention can achieve almost the same sound pressure energy at different operating frequencies;Figure 43 As shown, at a low frequency of 3Hz and a high frequency of 20Hz, the temperature of the surface of the expandable component 8 is almost the same when the shock wave is released the same number of times. This indicates that the temperature rise of the surface of the expandable component 8 of the shock wave device provided in this embodiment of the invention is almost the same at different operating frequencies.

[0152] like Figure 44 As shown, a plaster ring simulates the tissue structure of the area to be treated in the human body. The same number of shock waves were continuously released at both a low frequency of 1Hz and a high frequency of 20Hz. It can be seen that the number of plaster ring fragments is almost identical, and the fragmentation distance is also very small. However, under the same number of releases, the required shock wave release time is longer at low frequency and shorter at high frequency. That is, the treatment time is longer at low frequency and shorter at high frequency. This indicates that the shock wave device provided by this embodiment has almost consistent treatment effects at different operating frequencies, making it suitable for both low-frequency and high-frequency working conditions, meeting the needs of various applications. Furthermore, it can significantly shorten treatment time under high-frequency conditions, greatly improving treatment efficiency and avoiding prolonged vascular blockage, which is particularly significant in applications involving heart valves.

[0153] The following describes specific embodiments of the present invention in conjunction with the above-described specific implementation methods.

[0154] Example 1

[0155] like Figure 1 , Figure 2 and Figure 14 As shown, the shock wave device includes an electrode device, which includes two rigid conductive parts 1, electrode wires 2, and three electrode assemblies 3. Adjacent electrode assemblies 3 are electrically connected through the rigid conductive parts 1. The device has high structural strength, good connection reliability, and can withstand high-frequency and high-intensity shock wave energy. This effectively reduces the risk of electrode wires 2 easily breaking off under extreme working conditions and effectively extends the overall service life of the electrode device.

[0156] Furthermore, the three electrode assemblies 3 include a distal electrode assembly 31, an intermediate electrode assembly 33, and a proximal electrode assembly 32. In the axial direction of the electrode device, the intermediate electrode assembly 33 is spaced between the distal electrode assembly 31 and the proximal electrode assembly 32. The distal electrode assembly 31 is located at the farthest end of the electrode device, and the proximal electrode assembly 32 is located at the closest end of the electrode device. The distal electrode assembly 31 is coupled to the power supply through an electrode wire 2, and the proximal electrode assembly 32 is coupled to the power supply through another electrode wire 2. Compared with the original electrode device structure in which all electrical connections are made through electrode wires 2, the number of electrode wires 2 is reduced, and the weak points of electrical connection are reduced accordingly. This synergistically improves the overall durability of the electrode device, increasing the lifespan of the electrode device by at least two times.

[0157] Specifically, the hard conductive piece 1 is a conductive steel sheet, the thickness of the hard conductive piece 1 in the radial direction of the electrode assembly 3 is 0.3 mm, the conductive property is good, the assembly is convenient, and the strength is high.

[0158] Specifically, as shown in Figure 1 and Figure 2 , the distal electrode assembly 31 and the proximal electrode assembly 32 each include a first outer electrode 310, a first insulating layer 311 located inside the first outer electrode 310, and a first inner electrode 312 located inside the first insulating layer 311, the first inner electrode 312 is connected with the electrode wire 2, the first inner electrode 312 and the first outer electrode 310 are isolated by the first insulating layer 311, and the first outer electrode 310 and the first insulating layer 311 are provided with two first discharge holes 313 penetrating in the radial direction, one of the first discharge holes 313 exposes the first inner electrode 312, a first discharge gap is formed between the first outer electrode 310 and the first inner electrode 312 through the first discharge hole 313, so that the first inner electrode 312 and the first outer electrode 310 only discharge in the area range of the first discharge gap, and the two ends of the first insulating layer 311 in the axial direction at least protrude axially beyond the axial end of the first outer electrode 310, so as to avoid the first outer electrode 310 and the first inner electrode 312 from generating undesired discharge in an undesired area, greatly improving the discharge effectiveness, discharge strength and discharge reliability of the electrode assembly 3 as a whole.

[0159] In some exemplary embodiments, as shown in Figure 3 , the first inner electrode 312 is connected with the electrode wire 2 in a split manner, the end of the electrode wire 2 has a bare area and the rest is an insulating covered area, the bare area can be inserted into the first inner electrode 312, and then the first inner electrode 312 is flattened to realize the connection between the first inner electrode 312 and the electrode wire 2.

[0160] Specifically, as shown in Figure 1 , the two first discharge holes 313 are located in different areas of the first outer electrode 310 in the circumferential direction of the electrode device, one of the two first discharge holes 313 exposes the hard conductive piece 1, and the area of the hard conductive piece 1 exposed to the first discharge hole 313 can be reused as the second inner electrode 11 of the electrode assembly 3; or, the second inner electrodes 11 of adjacent two electrode assemblies 3 are shared, and the second inner electrode 11 is reused as the electrode wire 2 between the adjacent two electrode assemblies 3, which improves the utilization rate of the second inner electrode 11 while improving the electrical connection reliability and prolonging the service life of the electrode device.

[0161] Specifically, the intermediate electrode assembly 33 comprises a second outer electrode 330 and a second insulating layer 331 located inside the second outer electrode 330, and the second outer electrode 330 and the second insulating layer 331 are provided with two radially-through second discharge holes 332, the second discharge holes 332 expose the hard conductive piece 1, and the area of the hard conductive piece 1 exposed to the second discharge holes 332 can be reused as the third inner electrode 12 of the intermediate electrode assembly 33; or, the third inner electrode 12 of the intermediate electrode assembly 33 shares the inner electrode (the second inner electrode 11 or the adjacent third inner electrode 12) of the adjacent electrode assembly 3, and the third inner electrode 12 of the intermediate electrode assembly 33 is reused as the electrode wire 2 between the intermediate electrode assembly 33 and the adjacent electrode assembly 3, which improves the utilization of the third inner electrode 12 while improving the electrical connection reliability and prolonging the service life of the electrode device.

[0162] Through the second discharge holes 332, the second discharge gap is formed between the second outer electrode 330 and the third inner electrode 12, so that the third inner electrode 12 and the second outer electrode 330 only discharge in the area range of the second discharge gap, and the second insulating layer 331 protrudes at least axially from the axial end of the second outer electrode 330 in the axial direction of the electrode device, so as to avoid the occurrence of undesired discharge between the second outer electrode 330 and the third inner electrode 12 in the undesired area, greatly improving the discharge effectiveness, discharge intensity and discharge reliability of the entire intermediate electrode assembly 33; in this way, the inner electrode of the intermediate electrode assembly 33 does not need to be additionally arranged, and the discharge function and electrical connection function of the inner electrode can be realized at the same time through the hard conductive piece 1.

[0163] Specifically, the preset interval is 5.5 mm, that is, the axial interval between the discharge holes of the adjacent two electrode assemblies 3 is less than or equal to 5.5 mm, the axial interval between the discharge holes of the adjacent two electrode assemblies 3 is small, a multi-electrode compact series structure is formed in the entire electrode device, which can effectively cause high-intensity energy superposition between the plurality of electrode assemblies 3 while prolonging the impact wave energy coverage range generated by the entire electrode device, thereby improving the treatment effectiveness and treatment efficiency on the hard calcification.

[0164] It should be noted that the adjacent two electrode assemblies 3 are electrically connected through the hard conductive piece 1, which can further shorten the axial interval between the electrode assemblies 3 while improving the electrical connection strength and stability, improve the arrangement compactness of the electrode assemblies 3 in the electrode device, that is, the axial interval less than or equal to the preset interval can be realized on the basis of the electrical connection by the hard conductive piece 1, so as to achieve the near interval between the electrode assemblies 3 in the electrode device, the high-frequency and high-intensity impact wave force, and the performance of not being easy to be damaged, so that the electrode device can be applied to the extreme working condition of hard calcification (valve calcification) and emit long-life, high-frequency and high-intensity impact waves.

[0165] Specifically, as shown in Figure 6 the electrode wire 2 includes an extension section 21 and a limiting section 22, and the part of the electrode wire 2 exposed at least outside the first inner electrode 312 is an insulation covering area to prevent abnormal discharge on the electrode wire 2 from damaging the electrode wire 2 and the electrode assembly 3, and correspondingly, the part of the extension section 21 and the limiting section 22 exposed outside the first inner electrode 312 is also an insulation covering area, wherein the extension section 21 extends from the proximal end of the first inner electrode 312; and the limiting section 22 extends from the distal end of the first inner electrode 312; in this way, the electrode wire 2 protrudes towards the distal end, and even after the first inner electrode 312 is ablated, the first outer electrode 310 and the first insulation layer 311 on the side distal to the first discharge hole 313 can still exert a certain extrusion and limiting on the electrode wire 2, preventing the electrode wire 2 from immediately disintegrating and separating from the first inner electrode 312 and causing the electrode assembly 3 to fail.

[0166] Specifically, as shown in Figure 6 the electrode wire 2 connected to the distal electrode assembly 31 can pass through the outside of the second outer electrode 330 of the adjacent middle electrode assembly 33 and the outside of the first outer electrode 310 of the proximal electrode assembly 32, without affecting the discharge stability of the electrode device.

[0167] Specifically, as shown in Figure 8 and Figure 9 the first inner electrode 312 includes an integrated discharge area 3120 and a clamping area 3121, the first discharge hole 313 exposes at least part of the discharge area 3120 to form a first discharge gap between the discharge area 3120 and the first outer electrode 310; the clamping area 3121 is connected to the electrode wire 2, and the extension section 21 of the electrode wire 2 extends from the proximal end of the clamping area 3121, and the first discharge hole 313 can be axially extended towards the direction away from the clamping area 3121, in this way, the first discharge hole 313 is axially offset and away from the clamping area 3121 and the extension section 21 of the electrode wire 2, which can effectively reduce the influence of discharge ablation of the discharge area 3120 on the clamping area 3121, and further reduce the risk of the electrode wire 2 falling off.

[0168] Specifically, as shown in Figure 10As shown, the shock wave device further comprises a support 5, and the electrode device further comprises an inner insulation layer 4, which is arranged between the inner electrodes of the electrode assemblies 3 and the support 5; wherein in the distal electrode assembly 31 and the proximal electrode assembly 32, the inner insulation layer 4 specifically separates the first inner electrode 312 and the support 5, and separates the second inner electrode 11 and the support 5; in the middle electrode assembly 33, the inner insulation layer 4 specifically separates the third inner electrode 12 (i.e. the hard conductive member 1) and the support 5; in this way, the inner insulation layer 4 can form an effective insulation separation between the electrode assemblies 3 and the support 5, so as to avoid the support 5 from being damaged by the breakdown discharge and affecting the service life of the electrode device.

[0169] Specifically, as shown in the drawings, Figure 11 The electrode device further comprises an insulation coating layer 6, which is coated on the electrode assemblies 3 and exposes the discharge gaps of the electrode assemblies 3, specifically exposes the first discharge gap and the second discharge gap, and is filled between two adjacent electrode assemblies 3, that is, the insulation coating layer 6 coats all structures of the electrode device except the first discharge hole 313 and the second discharge hole 332. The insulation coating layer 6 can be formed by glue filling or the like, which can effectively limit the abnormal discharge of the non-discharge area, improve the overall structural firmness of the electrode device, reduce the risk of displacement of each component in the electrode device under high-frequency high-intensity shock wave, and greatly improve the discharge stability and durability.

[0170] In addition, in some preferred embodiments, the insulation coating layer 6 can also be used to seal and fix the limiting section 22 of the electrode wire 2, so as to further improve the limiting effect on the electrode wire 2, prevent the electrode wire 2 from disintegrating and falling off, and prolong the service life of the electrode device.

[0171] As shown in the drawings, Figure 17 And Figure 21As shown, the shock wave device further comprises an inner tube 7 and an inflatable component 8 sleeved on the inner tube 7, the support 5 is a deformable support 51, and the electrode device is arranged on the deformable support 51, wherein the inflatable component 8 and the inner tube 7 have a receiving cavity 81 therebetween, the deformable support 51 is located in the receiving cavity 81, the deformable support 51 can adjust the distance from the inner wall of the inflatable component 8 by deformation, and the deformable support 51 can move cooperatively with the electrode device by deformation, so that the deformable support 51 cooperates with the electrode device to be folded and close to the inner tube 7 or to be arched and close to the inner wall of the inflatable component 8; on the one hand, during the intervention of the shock wave device, the inflatable component 8 is in a wound and contracted state, so that the circumferential cross section of the entire shock wave device including the deformable support 51 and the electrode device is small, which is beneficial to the passage of the shock wave device, improves the passability and effectiveness and stability of reaching the treatment area, and facilitates subsequent accurate and effective treatment, on the other hand, after the inflatable component 8 of the shock wave device reaches the treatment area, the inflatable component 8 can be expanded, the deformable support 51 loses the pressure applied by the winding of the inflatable component 8, and can be arched and drive the electrode device to be close to the edge wall of the inflatable component 8, that is, the electrode device is closer to the treatment area, reduces the energy attenuation of the shock wave energy generated by the electrode device when reaching the treatment area, and effectively improves the treatment efficiency and treatment effect.

[0172] Specifically, the inner tube 7 is an adjustable bending pipe or an adjustable bending guide wire, which can freely adjust the bending direction and bending degree of the inner tube 7 during the intervention of the shock wave device, so as to facilitate the flexible adjustment of the shock wave device in the human body, improve the passability of the shock wave device, and adjust the position of the inflatable component 8 in the heart valve or blood vessel according to the treatment area, improve the effectiveness and accuracy of the inflatable component 8 of the shock wave device reaching the treatment area, and further improve the treatment efficiency and treatment safety.

[0173] As shown in Figure 17 The inflatable component 8 is wrapped on the inner tube 7 and can form a receiving cavity 81 therebetween, during the intervention of the shock wave device, the inflatable component 8 is in a wound and contracted state, at this time, the receiving cavity 81 almost does not exist, and the pressure applied by the winding of the inflatable component 8 can make the deformable support 51 in a folded state or a wound and folded state, and the deformable support 51 is close to the inner tube 7; and after the inflatable component 8 reaches the treatment area, the inflatable component 8 can be filled with liquid medium, so that the inflatable component 8 expands to an expanded state, increases the volume of the receiving cavity 81, at this time, the inflatable component 8 loses the constraint, and the receiving cavity 81 can reserve space for the subsequent arching of the deformable support 51, and improves the effectiveness of the subsequent arching of the deformable support 51.

[0174] Specifically, the cross section of the inflatable component 8 is circular, and the diameter of the inflatable component 8 is 20 mm, which refers to the diameter of the inflatable component 8 in the expanded state, which can reserve a certain volume of the accommodation cavity 81 for the arching of the deformable support 51, facilitate the reaching of the treatment area during the intervention, and make the spacing between the electrode device and the edge wall of the inflatable component 8 relatively small, reduce the attenuation of the shock wave energy released by the electrode device when reaching the treatment area, and improve the treatment efficiency.

[0175] Specifically, the wall thickness of the inflatable component 8 is greater than or equal to 0.065 mm, which is relatively thick and can provide a larger binding force to effectively cover the electrode device and the deformable support 51 on the inner tube 7 in the wound and contracted state, reduce the cross-sectional area of the shock wave device during the intervention, and improve the passability.

[0176] Specifically, as shown in Figure 17 the shock wave device further comprises an outer tube 9 sleeved on the inner tube 7, the inner diameter of the outer tube 9 is greater than the outer diameter of the inner tube 7, and the outer tube 9 and the inner tube 7 have a first gap 91, the distal end of the outer tube 9 is connected with the proximal end of the inflatable component 8, and the first gap 91 is communicated with the accommodation cavity 81, so as to facilitate the introduction of liquid medium into the accommodation cavity 81 through the first gap 91 of the outer tube 9 and the inner tube 7, so that the electrode device generates shock wave energy for treatment through the liquid-electric effect; wherein the outer tube 9 is a adjustable bending pipe, which can be bent together with the inner tube 7, has good flexibility, can adjust the position of the inflatable component 8 in the heart valve or blood vessel according to the treatment area, and improve the efficiency and accuracy of the inflatable component 8 of the shock wave device to reach the treatment area.

[0177] Specifically, the shock wave device comprises three deformable supports 51, each of which is provided with an electrode device, and the three deformable supports 51 are arranged equidistantly along the circumference of the inner tube 7 in the accommodation cavity 81, so that the shock wave can cover all directions of the inflatable component 8 when released, expand the coverage area of the shock wave energy and improve the treatment efficiency and treatment effect.

[0178] In addition, it should be noted that when the inflatable component 8 is in the wound and contracted state, the circumferential cross-sectional perimeter of the circumscribed shape composed of the deformable support 51, the electrode device and the inner tube 7 is smaller than the inner wall circumference of the pin at the proximal end of the inflatable component 8, so that the circumferential cross-sectional area of the inflatable component 8 as a whole in the wound and contracted state is relatively small, and the passability of the inflatable component 8 during the intervention is improved.

[0179] Specifically, the deformable support 51 is a pre-shaped support made of a metal material with a memory function, that is, the shape of the deformable support 51 after shaping is in an arched state, and after shaping, it is in a relatively soft state, and can be deformed to a collapsed state under the action of external force, facilitating the compression of the electrode device in the expandable component 8 and the overall retreat of the shock wave device, but in the absence of external force, it can recover to the arched state, effectively cooperate with the movement of the electrode device, so that the electrode device can play different roles in different working processes. When collapsed and close to the inner tube 7, it can facilitate the intervention of the shock wave device, or when arched and close to the edge wall of the expandable component 8, it can facilitate the reduction of the energy attenuation of the shock wave released by the electrode device to the treatment area, improving the treatment efficiency and treatment stability.

[0180] Among them, the material of the deformable support 51 includes nickel-titanium alloy, by adjusting the content of nickel in the nickel-titanium alloy, the AF point of the deformable support 51 can be adjusted, at the same time, by using a heat treatment temperature of 350°C and a heat treatment time, the phase transition temperature and microstructure of the nickel-titanium alloy can be changed, further adjusting the AF point of the deformable support 51, to improve the performance of the nickel-titanium alloy, so that the deformable support 51 after heat setting meets the needs of application in the shock wave device.

[0181] Specifically, the radial distance between the electrode device and the inner tube 7 in the arched state of the deformable support 51 is greater than the radial distance between the electrode device and the inner tube 7 in the collapsed state of the deformable support 51, so that the electrode device is close to the edge wall of the expandable component 8 with the deformable support 51 deformed and arched, shortens the distance between the electrode device and the treatment area, reduces the attenuation of the shock wave energy generated by the electrode device when reaching the treatment area, and improves the treatment efficiency and treatment reliability.

[0182] Specifically, as shown in Figure 29 The deformable support 51 is arched, the deformable support 51 includes a support portion 52, a bending portion 53 and a connecting portion 54, the electrode device is located on the support portion 52, the support portion 52 can be arched to cooperate with the electrode device to approach the edge wall of the expandable component 8 and reduce the attenuation of the shock wave energy released by the electrode device; one end of the support portion 52 is connected with one end of the bending portion 53, the other end of the bending portion 53 is connected with the connecting portion 54, likewise, the other end of the support portion 52 is connected with one end of the other bending portion 53, the other end of the other bending portion 53 is connected with the other connecting portion 54, and the two connecting portions 54 are respectively connected with the inner tube 7, so that the deformable support 51 is connected to the inner tube 7.

[0183] As shown in Figure 29As shown, in the arched state of the deformable support 51, the radial distance between the support portion 52 and the inner tube 7 is greater than the radial distance between the connecting portion 54 and the inner tube 7, and in the axial direction away from the support portion 52, the bending portion 53 gradually bends towards the inner tube 7, that is, the deformable support 51 gradually moves away from the inner tube 7 from the connecting portion 54 to the support portion 52, and approaches the side wall of the inflatable component 8, thereby reducing the attenuation of the shock wave energy generated by the electrode device.

[0184] Specifically, in the arched state of the deformable support 51, the radial distance between the electrode device and the inner wall of the inflatable component 8 is 2mm, and the radial distance between the electrode device and the side wall of the inflatable component 8 is smaller, which can effectively reduce the energy attenuation of the shock wave energy reaching the treatment area, and improve the treatment efficiency and treatment reliability.

[0185] Specifically, the arching height A of the support portion 52 of the deformable support 51 is determined based on the size of the inflatable component 8; assuming that the diameter of the inflatable component 8 is D, the arching height of the deformable support 51 satisfies the following formula:

[0186]

[0187] That is, the difference between the radius of the inflatable component 8 and the arching height of the deformable support 51 is 2mm.

[0188] Specifically, as shown in the drawings, Figure 17 the shock wave device includes a first connecting piece 84 and a second connecting piece 85, the first connecting piece 84 is fixedly connected with the distal end of the inner tube 7, the second connecting piece 85 is fixedly connected with the proximal end of the inner tube 7, and the end of the deformable support 51 is fixedly connected with the inner tube 7 through the first connecting piece 84 and the second connecting piece 85; wherein the first connecting piece 84 and the second connecting piece 85 are injection molded parts, which can effectively realize the assembly between the deformable support 51 and the inner tube 7, and improve the connection effectiveness and stability; when the inflatable component 8 is in the wound and contracted state, the deformable support 51 is contracted on the surface of the inner tube 7 under the pressure of the winding of the inflatable component 8, and after the expansion of the inflatable component 8, the deformable support 51 which loses the external force limitation can restore the original shape, especially the support portion 52 can approach the side wall of the expanded inflatable component 8 in cooperation with the electrode device, thereby reducing the energy attenuation of the shock wave generated by the electrode device when reaching the treatment area, improving the intensity of the shock wave acting on the treatment area, and improving the treatment efficiency.

[0189] Embodiment 2

[0190] The difference between this embodiment and embodiment 1 is that, as shown in the drawings, Figures 21-24 the shock wave device includes two deformable supports 51 arranged uniformly along the circumference of the inner tube 7; the rest is the same as embodiment 1.

[0191] Embodiment 3

[0192] The difference between this embodiment and embodiment 2 is that, as shown in Figure 35 two deformable supports 51 are integrally connected to each other at one end of the distal end of the inner tube 7 and fixedly connected to the inner tube 7, and the deformable supports 51 at the other end of the proximal end of the inner tube 7 are respectively fixedly connected to the inner tube 7; during assembly, the two deformable supports 51 can be assembled as a group, greatly improving the assembly efficiency.

[0193] Embodiment 4

[0194] The difference between this embodiment and embodiment 1 is that the first connecting member 84 and the second connecting member 85 are annular structures, and the end of the deformable support 51 is fixed to the inner wall of the annular structure; as shown in Figure 37 the first connecting member 84 is fixedly connected to the inner tube 7 to fix the distal end of the deformable support 51 to the distal end of the inner tube 7, and the second connecting member 85 is slidingly connected to the inner tube 7, and the second connecting member 85 can reciprocally move along the axial direction of the inner tube 7 under the action of an external force, so that the proximal end of the deformable support 51 is in a movable state, driving the deformable support 51 to fold or arch; in the arched state, the axial length is reduced, the radial height is increased, especially the radial height of the support portion 52 is increased, and the electrode device is close to the side wall of the inflatable member 8, so as to reduce the energy attenuation, enhance the strength of the shock wave energy acting on the treatment area, and improve the treatment efficiency; in the process of changing to the folded state, the deformable support 51 is relatively soft, the axial length of the deformable support 51 is increased, and even completely straightened, and the structure of part of the deformable support 51 can extend into the first gap 91 of the outer tube 9, at the same time, the radial height is reduced, and the electrode device is close to the inner tube 7, so that the shock wave device can smoothly intervene or be withdrawn after the treatment is completed.

[0195] Specifically, the shock wave device further comprises a push-pull piece 86, one end of the push-pull piece 86 is fixedly connected with the second connecting piece 85, and is used to apply an external force to the second connecting piece 85 to drive the second connecting piece 85 to reciprocate along the axial direction of the inner tube 7 under the action of the external force. When the push-pull piece 86 applies a pushing force to the second connecting piece 85, the second connecting piece 85 can be pushed into the accommodating cavity 81 of the inflatable component 8 together with the deformable support 51. At this time, the deformable support 51 is not subjected to the pressure applied by the inner wall of the outer tube 9, and the inflatable component 8 in the expanded state also does not generate pressure on the deformable support 51. The proximal end of the deformable support 51 gradually arches during the movement towards the distal end of the inner tube 7, and cooperates with the electrode device to approach the side wall of the inflatable component 8, so as to effectively reduce the attenuation of the shock wave energy. Conversely, when the push-pull piece 86 applies a pulling force to the second connecting piece 85, the proximal end of the deformable support 51 can be straightened together with the second connecting piece 85, that is, the deformable support 51 gradually contracts and approaches the inner tube 7. The proximal end of the deformable support 51 can be pulled into the first gap 91 between the outer tube 9 and the inner tube 7. The deformable support 51 is deformed by the pressure of the outer tube 9 and the pulling force of the push-pull piece 86, and gradually contracts on the inner tube 7. The overall operation is convenient, and the control precision is high.

[0196] The shock wave device further comprises an operation handle, the other end of the push-pull piece 86 is connected with the operation handle. The operation handle can comprise an adjusting knob. By rotating the adjusting knob, the push-pull piece 86 can be controlled to pull or push the second connecting piece 85 and the deformable support 51. The control is convenient and fast.

[0197] Embodiment 5

[0198] The difference between this embodiment and embodiment 4 is that, as shown in Figure 38 the first connecting piece 84 is movably connected with the inner tube 7, that is, both ends of the deformable support 51 are movable, and can drive the entire deformable support 51 and the electrode device to reciprocate along the axial direction of the inner tube 7 under the action of an external force. The structure of the deformable support 51 or even the electrode device can be entirely retracted in the first gap 91 of the outer tube 9 in the non-shock wave release stage. In the retracted state, the radial height of the deformable support 51 is greatly reduced, which facilitates the reduction of the circumferential area of the inflatable component 8 to facilitate the intervention or withdrawal of the inflatable component 8. Conversely, the deformable support 51 can be easily pushed out of the first gap 91 of the outer tube 9 into the accommodating cavity 81. Under the action of no external force, the deformable support 51 is effectively arched to approach the side wall of the inflatable component 8 together with the electrode device, the radial distance between the electrode device and the side wall of the inflatable component 8 is shortened, and the treatment efficiency is improved.

[0199] Embodiment 6

[0200] The difference between this embodiment and embodiment 1 is that, as shown in Figure 30As shown, the deformable support 51 includes a limiting portion 55 which abuts against the inner wall of the inflatable part 8 in the radial direction of the inner tube 7 in the arched state, and the electrode device is located between two adjacent limiting portions 55 in the axial direction, and has good balance; the limiting portion 55 is a spacer block provided on the support portion 52, and has a certain width in the radial direction, and can abut against the inner wall of the inflatable part 8, while the width of the electrode device in the radial direction is smaller than the radial width of the spacer block, so that a certain space is always left between the electrode device and the inner wall of the inflatable part 8, preventing the electrode device from directly contacting the inner wall of the inflatable part 8 and breaking the inflatable part 8 in the discharge process, greatly improving the treatment stability and treatment safety, and prolonging the service life of the shock wave device.

[0201] Embodiment 7

[0202] The difference between this embodiment and embodiment 6 is that, as shown, Figure 31 the limiting portion 55 is a bent portion 53, so that in the arched state of the deformable support 51, the bent portion 53 is attached to the inner wall of the tapered section of the inflatable part 8, so that the inner wall of the tapered section of the inflatable part 8 limits the bent portion 53, and even if the proximal end is bent due to the pressure of the blood vessel during the intervention process, it is not easy to affect the support portion 52 located between the two bent portions 53, that is, the radial distance between the electrode device provided on the support portion 52 and the inner wall of the inflatable part 8 can still be effectively kept constant; and the length of the bent portion 53 in the axial direction of the inner tube 7 is smaller than the length of the tapered section of the inflatable part 8 in the axial direction of the inner tube 7, and similarly, the width of the bent portion 53 in the radial direction of the inner tube 7 is also smaller than the width of the tapered section of the inflatable part 8 in the radial direction of the inner tube 7, so that the maximum arching height of the support portion 52 is always smaller than the arching height of the middle part of the inflatable part 8, avoiding the contact between the electrode device provided on the support portion 52 and the inner wall of the inflatable part 8, greatly reducing the risk of breaking the inflatable part 8 in the discharge process, improving the discharge stability and discharge safety, and prolonging the service life of the shock wave device.

[0203] Embodiment 8

[0204] The difference between this embodiment and embodiment 6 is that, as shown, Figure 32As shown, the limiting portion 55 is located between the supporting portion 52 and the bending portion 53, and the end of the limiting portion 55 connected with the supporting portion 52 is radially recessed towards the inner tube 7. In this way, the position of the limiting portion 55 farthest from the inner tube 7 in the radial direction can be in contact with the inner wall of the inflatable member 8, so as to effectively limit the radial position of the supporting portion 52 between the two limiting portions 55 to be constant. Meanwhile, the limiting portion 55 is gradually recessed towards the supporting portion 52, which increases the radial distance between the supporting portion 52 and the inner wall of the inflatable member 8, so that the electrode device arranged on the supporting portion 52 can have a certain radial distance with the inner wall of the inflatable member 8, thereby preventing the proximal end from being bent to drive the deformable supporting member 51 to contact the inner wall of the inflatable member 8 together with the electrode device, which greatly prolongs the service life of the inflatable member 8 and improves the stability, reliability and safety of treatment during discharge.

[0205] Embodiment 9

[0206] The difference between this embodiment and embodiment 6 is that, as shown, Figure 33 The inflatable member 8 is a special-shaped inflatable member, which includes a fitting portion 82 and a protruding portion 83. The protruding portion 83 is located between two adjacent fitting portions 82 in the axial direction of the inner tube 7. In the expanded state of the inflatable member 8, the radial distance between the inner wall of the protruding portion 83 and the inner tube 7 is greater than that between the fitting portion 82 and the inner tube 7. The fitting portion 82 is used to abut against the limiting portion 55, so as to limit the position of the electrode device on the deformable supporting member 51. The protruding portion 83 is used to increase the radial distance between the inner wall of the inflatable member 8 and the electrode device, so as to further avoid the contact between the electrode device and the inner wall of the inflatable member 8.

[0207] The limiting portion 55 is located on the end of the supporting portion 52 connected with the bending portion 53, which can be in contact with and abut against the inner wall of the fitting portion 82 in the arched state of the deformable supporting member 51, and cooperate with the protruding portion 83 radially protruding away from the inner tube 7, so as to limit the electrode device between the two limiting portions 55 from contacting the inflatable member 8 and maintain the radial distance between them constant in the working state, which has good limiting reliability.

[0208] Embodiment 10

[0209] The difference between this embodiment and embodiment 6 is that the shock wave device includes three inflatable members 8, which are arranged on the circumferential side of the inner tube 7. The supporting member 5 is made of hard material, and the distal end of the supporting member 5 protrudes out of the inflatable member 8 and is connected with the distal end of the inner tube 7.

[0210] Embodiment 11

[0211] The difference between this embodiment and embodiment 8 is that the shock wave device comprises three inflatable components 8 arranged circumferentially on the side of the inner tube 7, the support 5 is made of hard material, and the distal end of the support 5 protrudes the inflatable component 8 and is connected to the distal end of the inner tube 7.

[0212] Embodiment 12

[0213] The difference between this embodiment and embodiment 11 is that the support 5 is a deformable support 51; the rest is the same as embodiment 11.

[0214] Embodiment 13

[0215] The difference between this embodiment and embodiment 1 is that the electrode device comprises two electrode assemblies 3, namely a distal electrode assembly 31 and a proximal electrode assembly 32, and does not comprise a middle electrode assembly 33, the distal electrode assembly 31 and the proximal electrode assembly 32 are electrically connected through a hard conductive piece 1, and the area of the hard conductive piece 1 exposed to the first discharge hole 313 of the distal electrode assembly 31 can be reused as the second inner electrode 11 of the distal electrode assembly 31, and the area of the hard conductive piece 1 exposed to the first discharge hole 313 of the proximal electrode assembly 32 can be reused as the second inner electrode 11 of the proximal electrode assembly 32, which not only improves the electrical connection reliability and prolongs the service life of the electrode device, but also improves the utilization rate of the inner electrode inside the electrode device; the rest is the same as embodiment 1.

[0216] Embodiment 14

[0217] The difference between this embodiment and embodiment 1 is that the electrode device comprises two middle electrode assemblies 33, the two middle electrode assemblies 33 are electrically connected through a hard conductive piece 1, the discharge range of the electrode device is extended to cover a larger treatment area, and the superposition of shock wave energy between multiple electrode assemblies 3 can be generated; the rest is the same as embodiment 1.

[0218] Embodiment 15

[0219] The difference between this embodiment and embodiment 1 is that the preset interval is 5.0 mm, that is, the axial interval between the discharge holes of adjacent two electrode assemblies 3 is less than or equal to 5.0 mm; the rest is the same as embodiment 1.

[0220] Embodiment 16

[0221] The difference between this embodiment and embodiment 1 is that an electrode wire 2 connected to the distal electrode assembly 31 can be led out through the inside of the second insulating layer 331 of the adjacent middle electrode assembly 33 and the inside of the first insulating layer 311 of the proximal electrode assembly 32; the rest is the same as embodiment 1.

[0222] Embodiment 17

[0223] The embodiment is different from the embodiment 1 in that the part of the hard conductive member 1 can also be arranged on the first inner electrode 312 to further improve the reliability of the electrical connection on the first inner electrode 312; the first inner electrode 312 has a hard electrical connection area, the hard electrical connection area is an integral structure, the material of the hard electrical connection area includes hard metal, the hard metal includes at least one of steel, titanium alloy, copper alloy, nickel alloy and aluminum alloy, that is, the hard electrical connection area is the same as the hard conductive member 1, the hard electrical connection area is located at one end of the first inner electrode 312 away from the clamping area 3121, and the hard electrical connection area forms a first discharge gap with the first outer electrode 310 through the first discharge hole 313.

[0224] Embodiment 18

[0225] The embodiment is different from the embodiment 1 in that, as shown in Figures 13-16 The shock wave device includes three inflatable components 8 with electrode devices and one inflatable component 8 without an electrode device, the outer tube 9 includes one second gap 93 and three first gaps 91 arranged in a circumferential direction, each first gap 91 is fixed with one inflatable component 8, and provides a liquid passage and an electrical circuit passage for the internal accommodating cavity 81 of the inflatable component 8; and the second gap 93 is fixed with one inflatable component 8, the inflatable component 8 is not provided with an electrode device, is used as a guide wire accommodating passage, and provides a liquid passage, so that the release of high-strength and high-frequency shock waves is effectively realized in the working state, and the stability is good.

[0226] The above only describes some embodiments of the present application and is not used to limit the present application. It should be understood by those skilled in the art that the present application can have various changes and improvements, and any modification, equivalent replacement and improvement according to the present application all fall within the scope of the present application.

Claims

1. An electrode device for a heart valve calcification treatment device, characterized by, The electrode device comprises at least one hard conductive piece (1), electrode wires (2) and at least two electrode assemblies (3), adjacent electrode assemblies (3) are electrically connected through the hard conductive piece (1), and the hard conductive piece (1) is an integral structure. The at least two electrode assemblies (3) comprise a distal electrode assembly (31) and a proximal electrode assembly (32), the distal electrode assembly (31) is coupled with a power supply through one electrode wire (2), and the proximal electrode assembly (32) is coupled with the power supply through another electrode wire (2).

2. The electrode device of claim 1, wherein, The distal electrode assembly (31) and the proximal electrode assembly (32) each comprise a first outer electrode (310), a first insulating layer (311) located inside the first outer electrode (310) and a first inner electrode (312) located inside the first insulating layer (311), the first inner electrode (312) is connected with the electrode wire (2), the first outer electrode (310) and the first insulating layer (311) are provided with at least one first discharge hole (313) penetrating in a radial direction, at least one of the at least one first discharge hole (313) exposes the first inner electrode (312), and a first discharge gap is formed between the first outer electrode (310) and the first inner electrode (312) through the first discharge hole (313).

3. The electrode device of claim 2, wherein, The first outer electrode (310) and the first insulating layer (311) are provided with at least two first discharge holes (313) penetrating in a radial direction, at least one of the at least two first discharge holes (313) exposes the hard conductive piece (1), and the area of the hard conductive piece (1) exposed to the first discharge hole (313) can be reused as a second inner electrode (11) of the electrode assembly (3).

4. The electrode device of claim 1, wherein, The at least two electrode assemblies (3) further comprise at least one intermediate electrode assembly (33), and the intermediate electrode assembly (33) is arranged between the distal electrode assembly (31) and the proximal electrode assembly (32) in the axial direction of the electrode device. The intermediate electrode assembly (33) comprises a second outer electrode (330) and a second insulating layer (331) located inside the second outer electrode (330), and the second outer electrode (330) and the second insulating layer (331) are provided with at least one second discharge hole (332) penetrating in a radial direction, the second discharge hole (332) exposes the hard conductive piece (1), and the area of the hard conductive piece (1) exposed to the second discharge hole (332) can be reused as a third inner electrode (12) of the intermediate electrode assembly (33). A second discharge gap is formed between the second outer electrode (330) and the third inner electrode (12) through the second discharge hole (332).

5. The electrode device of claim 2, wherein, The first inner electrode (312) comprises a discharge area (3120) and a clamping area (3121) connected integrally, the first discharge hole (313) exposes at least part of the discharge area (3120), the clamping area (3121) is connected with the electrode wire (2), and the first discharge hole (313) is arranged axially offset and away from the clamping area (3121).

6. The electrode device according to any one of claims 1 to 5, characterized in that The material of the hard conductive member (1) comprises a hard metal, and the hard metal comprises at least one of steel, titanium alloy, copper alloy, nickel alloy and aluminum alloy.

7. The electrode device according to any one of claims 1 to 5, characterized in that The axial spacing between the discharge holes of two adjacent electrode assemblies (3) is less than or equal to a preset spacing, and the preset spacing is 4.8mm-5.5mm.

8. The electrode device according to any one of claims 1 to 5, characterized by The electrode wire (2) comprises a leading section (21) and a limiting section (22), the leading section (21) extends from the proximal end of the electrode assembly (3), and the limiting section (22) extends from the distal end of the electrode assembly (3).

9. The electrode device according to any of claims 1-5, said heart valve calcification treatment device comprising a support member (5), characterized in that, The electrode device further comprises an inner insulation layer (4) arranged between the inner electrode of the electrode assembly (3) and the support (5).

10. The electrode device according to any one of claims 1 to 5, characterized in that The electrode device further comprises an insulation covering layer (6) at least partially covering the electrode assembly (3) and exposing the discharge gap of the electrode assembly (3), and the insulation covering layer (6) is filled between two adjacent electrode assemblies (3).

11. A shockwave device characterized by, The electrode device comprises an inner tube (7), an expandable component (8) connected to part of the inner tube (7), and a support (5), and the electrode device is as claimed in any one of claims 1-10, the expandable component (8) has a receiving cavity (81) therein, the support (5) is at least partially located in the receiving cavity (81), and the distal end of the support (5) is connected with the inner tube (7); the electrode device is arranged on the support (5), and in a working state, the radial spacing between the electrode device and the expandable component (8) is constant.

12. The shockwave device of claim 11, wherein, The support (5) comprises a limiting portion (55) which abuts against the inner wall of the expandable component (8) in the radial direction, and the electrode device is located axially between two adjacent limiting portions (55).

13. The shock wave device of claim 11, wherein, The support (5) is a deformable support (51) which can adjust the distance between the inner wall of the expandable component (8) by deformation; and the deformable support (51) can move cooperatively with the electrode device by deformation, so that the deformable support (51) cooperates with the electrode device to fold and approach the inner tube (7) or arch and move away from the inner tube (7).

14. The shockwave device of claim 11, wherein, The shock wave device comprises a plurality of expandable components (8) which are arranged circumferentially on the side of the inner tube (7).

15. The shock wave device of claim 11, wherein, The shock wave device comprises a single expandable component (8) which is sleeved on part of the inner tube (7), and the receiving cavity (81) is located between the expandable component (8) and the inner tube (7).

16. The shock wave device of claim 12, wherein, The expandable component (8) is a special-shaped expandable component, which comprises a fitting part (82) and a protruding part (83), the protruding part (83) is located between two adjacent fitting parts (82) in the axial direction, the radial distance between the inner wall of the protruding part (83) and the inner tube (7) is greater than the radial distance between the fitting part (82) and the inner tube (7) in the expanded state of the expandable component (8); in the arched state of the support member (5), the limiting part (55) of the support member (5) is fitted with the inner wall of the fitting part (82).

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