Electrode assembly and shock wave device using the same

Abstract

The present invention provides an electrode assembly for a shock wave device, the electrode assembly is arranged inside the balloon of the shock wave device, and the electrode assembly comprises: a first electrode; an insulating layer, the first electrode is arranged inside the insulating layer and the end of the first electrode is exposed from the end of the insulating layer; a first conductor, the first conductor is arranged on at least a part of the outer peripheral surface of the end of the insulating layer; a second electrode, the second electrode is arranged on at least a part of the outer peripheral surface of the base end of the insulating layer, so that there is an insulating gap between the second electrode and the first conductor. The electrode assembly of the present invention can not only effectively reduce the attenuation of the shock wave during the conduction process, but also effectively prolong the service life of the electrode assembly, thereby safely and reliably achieving a satisfactory treatment effect.

Description

Technical Field

[0001] The invention belongs to the field of medical technology, and in particular relates to an electrode for a shock wave device for treating heart valve or blood vessel calcification, a shock wave device using the electrode, and a method for treating animal heart valve or blood vessel calcification. Background Art

[0002] Heart valve calcification is the main pathological manifestation of heart valve stenosis and regurgitation, which usually occurs in the elderly; vascular calcification is a common pathological manifestation of atherosclerosis, hypertension, diabetic vascular disease, vascular damage, chronic kidney disease and aging.

[0003] Currently, shock wave balloon technology has been used to treat heart valve or vascular calcification due to its advantages of easy operation and balloon pre-expansion. Figure 1 As shown, a shock wave device 900 for treating heart valve calcification in the prior art includes a shock wave transmitter 920 and a balloon 910. The shock wave transmitter 920 includes an electrode cable and an electrode assembly 922, the electrode cable receives and conducts voltage / current pulses, and the electrode assembly 922 is electrically connected to the electrode cable for receiving voltage / current pulses to generate shock waves. The balloon 910 is wrapped around the outside of the shock wave transmitter 920 and has retractable, foldable and insulating properties. The balloon 910 also has a through hole for liquid to flow in, so that the inside of the balloon 910 is filled with liquid. When the inside of the balloon 910 is filled with liquid, the balloon 910 is filled so that at least a portion of the outer surface of the balloon 910 contacts the heart valve or blood vessel with calcified lesions (hereinafter sometimes referred to as "calcified lesions" or "heart valve or blood vessel with calcified lesions"). The shock wave generated by the electrode assembly 922 is radially transmitted to the surface of the balloon 910 through the liquid inside the balloon 910, and then transmitted to the calcified lesion through the surface of the balloon. When the shock wave is transmitted to the calcified lesion, the compression stress of the shock wave will cause the calcified tissue at the calcified lesion to break. The shock wave of appropriate intensity can satisfy the requirement of destroying the calcified tissue without generating additional burden on the soft tissue around the calcified tissue.

[0004] However, the electrode assembly of the shock wave device in the prior art is mainly composed of a metal conductor and an insulating sheath, and the treatment of calcified heart valve lesions often requires higher energy. The voltage between the positive and negative electrodes of the shock wave electrode may reach 7-10KV. When the electrode discharges, it will generate strong thermal energy and mechanical energy, which will cause destructive impacts on the shock wave electrode structure and put a great test on the life of the shock wave electrode. In addition, in the case of severe calcification of the heart valve or blood vessels, it is often difficult for the balloon of the shock wave device to smoothly enter the calcified lesion. Therefore, there is a need for improvement in improving the accuracy and effectiveness of treatment for calcified lesions, increasing the service life of shock wave electrodes under high pressure, and optimizing the design of electrode control systems.

[0005] In addition, in the shock wave device with multiple balloons and / or multiple shock wave transmitters in the prior art, a low-voltage front-end multi-channel control method is adopted. In this control method, a multi-channel control circuit is arranged before the boost circuit, and each circuit requires a separate boost circuit and a high-voltage trigger switch. Since the boost components and the high-voltage trigger switch are large in size, the overall circuit volume is large, resulting in a large shock wave device volume, which in turn leads to the problem of inconvenience in operation during the interventional surgery. Summary of the invention

[0006] In view of the above-mentioned technical problems existing in the prior art, the present invention provides an electrode assembly for a shock wave device for treating heart valve or vascular calcification, which can effectively reduce the attenuation of shock waves during the conduction process, and achieve a satisfactory treatment effect on heart valve or vascular calcification. In addition, the electrode assembly of the present invention can significantly extend the service life of the electrode and the shock wave device. The electrode assembly of the present invention can also enable the shock wave device to quickly enter the calcified lesion of the heart valve, effectively shortening the operation time. In addition, the present invention also provides a shock wave device using the electrode assembly of the present invention, a control system for controlling the shock wave device of the present invention, and a method for treating heart valve or vascular calcification using the shock wave device of the present invention.

[0007] In order to solve the above technical problems, one aspect of an embodiment of the present invention provides an electrode assembly for a shock wave device, wherein the electrode assembly is arranged inside a balloon of the shock wave device, and the electrode assembly comprises:

[0008] a first electrode;

[0009] an insulating layer, wherein the first electrode is disposed inside the insulating layer and an end of the first electrode is exposed from an end of the insulating layer;

[0010] a first conductor disposed on at least a portion of an outer peripheral surface of a terminal end of the insulating layer;

[0011] A second electrode is provided on at least a portion of an outer peripheral surface of a base end of the insulating layer so that an insulating gap exists between the second electrode and the first conductor.

[0012] In an electrode assembly according to one aspect of an embodiment of the present invention, at least one of the first conductor and the second electrode has a protrusion extending from one of the first conductor and the second electrode along the outer peripheral surface of the insulating layer toward the other of the first conductor and the second electrode.

[0013] According to one aspect of an embodiment of the present invention, the electrode assembly further includes at least one second conductor, which is arranged on at least a portion of the outer peripheral surface of the insulating layer and is located between the first conductor and the second electrode, so that there is an insulating gap between the first conductor and the second conductor and between the second conductor and the second electrode.

[0014] In the electrode assembly according to one aspect of the embodiment of the present invention, at least one of the second electrical conductors has a protrusion extending from the second electrical conductor along the outer circumference of the insulating layer toward a base end or a distal end of the insulating layer.

[0015] In an electrode assembly according to one aspect of an embodiment of the present invention, the first conductor, the second conductor and the second electrode have two or more protrusions in total, and the two or more protrusions are spaced apart at an angle α in the circumferential direction of the insulating layer, α=360° / N, where N is the number of the protrusions.

[0016] According to an electrode assembly of one aspect of an embodiment of the present invention, the first electrode is movable inside the insulating layer along the length direction of the insulating layer, and

[0017] The first electrode has a connecting portion at a distal end thereof, and the connecting portion electrically connects or disconnects the first electrode and the first conductor as the first electrode moves.

[0018] In the electrode assembly according to one aspect of an embodiment of the present invention, the first electrode is a rod-shaped electrode with a diameter of 0.1 to 1.0 mm, preferably 0.1 to 0.5 mm.

[0019] In the electrode assembly according to one aspect of the embodiments of the present invention, the second electrode is a ring-shaped electrode with a wall thickness of 0.1 to 1.0 mm.

[0020] In the electrode assembly according to one aspect of an embodiment of the present invention, each of the first conductor and the second conductor is a ring-shaped conductor with a wall thickness of 0.1 to 1.0 mm.

[0021] In the electrode assembly according to one aspect of the embodiments of the present invention, the insulating layer is a cylindrical insulating sheath with a wall thickness of 0.1 to 1.0 mm.

[0022] Another aspect of an embodiment of the present invention provides a shock wave device, which includes the electrode assembly of the present invention.

[0023] Another aspect of an embodiment of the present invention provides a shock wave device, the shock wave device comprises two or more balloons, and

[0024] At least one of the two or more balloons is provided with an electrode assembly including the above-mentioned present invention inside.

[0025] Another aspect of the embodiments of the present invention provides a method for treating heart valve calcification, wherein the method uses the shock wave device of the present invention to treat the calcified portion of the heart valve.

[0026] According to one embodiment of the present invention, an electrode assembly for a shock wave device for treating heart valve or vascular calcification can be provided. The electrode assembly can not only effectively reduce the attenuation of the shock wave during the conduction process, but also effectively extend the service life of the electrode assembly, thereby safely and reliably achieving a satisfactory treatment effect. In addition, the shock wave device of the present invention is simple to operate, and the requirements for the operator's proficiency in operation are significantly reduced, thereby significantly shortening the operation time, reducing the burden on the treatment object, thereby improving the success rate of the operation, and effectively reducing various risks during the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following briefly introduces the drawings required for describing the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative work, among which:

[0028] Figure 1 It is a structural schematic diagram of a shock wave device of the prior art;

[0029] Figure 2 is a schematic structural diagram of an embodiment of the shock wave device of the present invention;

[0030] Figure 3 is a schematic diagram of a use state of an embodiment of the shock wave device of the present invention;

[0031] Figure 4 is a cross-sectional schematic diagram of the balloon portion of the shock wave device of the present invention in a working state;

[0032] Figure 5is a schematic diagram of an embodiment of an electrode assembly for a shock wave device of the present invention;

[0033] Fig. 6A and 6B is a schematic diagram of an improved example of an electrode assembly for a shock wave device of the present invention;

[0034] Fig. 7A and 7B is a schematic diagram of a circuit control system of an improved example of an electrode assembly of a shock wave device of the present invention; and

[0035] Figure 8 It is a schematic diagram of a circuit control system of the shock wave device of the present invention. DETAILED DESCRIPTION

[0036] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0037] In the present application, "shock wave" is a general term for various forms of waves (such as pressure waves, etc.) that can be generated by an electrode assembly during discharge, and is not used to limit specific wave forms.

[0038] In the present application, the "distal end" or "tip" of a shock wave device or an electrode assembly or other component thereof refers to the end toward the lead tip that enters the body of the treated subject during surgery, while the "proximal end" or "base end" of a shock wave device or its component refers to the end toward the handle that remains outside the body of the treated subject during surgery.

[0039] In this application, "multiple" means two or more than two. In view of this, in the embodiments of the present invention, "multiple" can also be understood as "at least two". "And / or" describes the association relationship of associated objects, indicating that three relationships can exist. For example, A and / or B can represent: A exists alone, A and B exist at the same time, and B exists alone. In addition, the character " / ", unless otherwise specified, generally indicates that the associated objects before and after are in an "or" relationship.

[0040] In this application, "heart valve" and "valve" are collectively referred to valves including the mitral valve, tricuspid valve and aortic valve. In this application, "heart valves and blood vessels with calcified lesions" are sometimes referred to as "heart valves and blood vessels with calcified lesions" or "calcified lesions".

[0041] Shockwave device

[0042] like Figure 2 As shown, a shock wave device 100 of an embodiment of the present invention may include at least one balloon 10. The balloon 10 has at least one balloon body. Preferably, the balloon body of the balloon 10 is cylindrical after being filled. As long as the balloon body of the balloon 10 after being filled is cylindrical, the shapes of the two ends of the balloon 10 in the length direction are not specifically limited. More preferably, the cylindrical balloon bodies of the balloon 10 are parallel to each other in the length direction. Specifically, the axes of the cylindrical balloon bodies of the balloon 10 in their respective length directions are parallel to each other. The balloon 10 of the shock wave device of the present invention may also have other shapes. For example, in one embodiment of the present invention, the balloon 10 may have a plurality of balloon bodies, which may have the same shape, such as a cylinder, after being filled with liquid, and these balloon bodies are interconnected so that liquid can flow between these balloon bodies.

[0043] The balloon 10 can be formed of a polymer material as a semi-compliant or non-compliant balloon, and has retractable, foldable and insulating properties. There is no specific limitation on the material forming the balloon 10, for example, it can be nylon, polyether block amide (PEBA) or polyethylene terephthalate (PET). The balloon 10 also has at least one through hole, which is connected to the connecting tube A14 and is used to inject liquid into the balloon 10 to fill the balloon 10. When the balloon 10 is filled with liquid, the balloon 10 is filled so that at least a portion of the outer surface of the balloon 10 contacts the heart valve or blood vessel (calcified lesion) with calcified lesions.

[0044] At least one shock wave transmitter 20 is disposed inside the balloon 10, and the shock wave transmitter 20 is used to receive voltage / current pulses and generate shock waves. Figure 2 As shown, at least one shock wave transmitter 20 is disposed in each balloon body of the balloon 10. The shock wave transmitter 20 includes at least one electrode cable 21 and at least one electrode assembly 30. The electrode cable 21 receives and conducts voltage / current pulses. The electrode assembly 30 is electrically connected to the electrode cable 21 and is used to receive voltage / current pulses to generate shock waves. The shock waves generated by the electrode assembly 30 are radially conducted to the surface of the balloon 10 via the liquid inside the balloon 10, and then conducted to the calcified lesion via the surface of the balloon.

[0045] like Figure 3 As shown, during the operation, the balloon 10 of the shock wave device 100 is positioned at, for example, the position of the heart valve. Preferably, the position of the electrode assembly 30 in the balloon 10 corresponds to the calcified lesion, so that the distance between the electrode assembly 30 and the calcified lesion is the shortest.

[0046] Figure 4 Shows Figure 3FIG. 1 is a cross-sectional schematic diagram of the balloon portion of the shock wave device 100 in a working state (after being filled). Figure 4 As shown, each balloon 10 includes a shock wave transmitter 20 disposed inside its balloon body. Figure 1 In the shock wave device 900 of the prior art shown in the figure, when the shock wave device 100 of one embodiment of the present invention is used, the distance from the electrode assembly 30 of the shock wave transmitter 20 generating the shock wave to the outer surface of the portion of the balloon 10 that contacts the calcified lesion is significantly shortened. Therefore, even when the shock wave generated by a relatively low voltage / current pulse is transmitted to the calcified lesion, it can maintain sufficient intensity, thereby obtaining a satisfactory treatment effect.

[0047] On the other hand, since the shock wave device 100 of the present invention has the above structure, that is, the cylindrical balloon bodies of the balloons 10 in the shock wave device 100 are parallel to each other, during the operation, when the balloon contacts the calcified lesion, the balloon is not easily displaced due to slight squeezing of the valve, and therefore, the medical staff only needs to perform simple positioning operations to obtain satisfactory treatment effects. The shock wave device 100 of the embodiment of the present invention significantly reduces the operator's operating proficiency requirements, so that an operator with ordinary interventional surgery experience can skillfully operate the shock wave device 100 of the present invention. Therefore, it is possible to significantly shorten the operation time, reduce the burden on the treatment object, thereby improving the success rate of the operation, and reducing various risks during the operation.

[0048] On the other hand, in one embodiment of the present invention, since a plurality of balloons 10 are provided, there are gaps between the balloons 10 for blood to pass through, which can ensure that the surgery can be performed with smooth blood flow, thereby reducing the burden of the surgery on the treatment object. Figure 4 As shown, after the multiple balloons 10 (3 in the figure) are filled, the outer area of ​​the balloon and the inner area of ​​the balloon ( Figure 4 There is enough clearance in the C section. Figure 4 In the illustrated embodiment of the present invention, the shock wave device 100 is provided with three balloons 10 , but in other embodiments of the present invention, the number of balloons 10 may be two, four or more.

[0049] In the shock wave device 100 of one embodiment of the present invention, the diameter of the main part of the balloon 10 is 2-12 mm. The diameter of the balloon 10 is preferably 6-10 mm, and more preferably 8-10 mm. When the diameter of the balloon is greater than 12 mm, the distance between the electrode assembly and the calcified lesion increases, and there is a risk of excessive attenuation of the intensity of the shock wave.

[0050] The length of the main part of the balloon 10 is 20-60 mm, for example, 20 mm, 35 mm, 40 mm, 55 mm or 60 mm. When the length of the balloon 10 is too long, there is a possibility of causing damage to the heart tissue during the operation, and it is too difficult to pass through the corners when the shock wave device is delivered during the interventional operation. On the other hand, when the length of the balloon 10 is too short, it will increase the difficulty of positioning the shock wave device during the operation.

[0051] There is no particular limitation on the liquid injected into the balloon 10 used in the shock wave device 100 of the present invention. The liquid may be an electrolyte liquid, such as physiological saline, or a non-electrolyte liquid, such as glycerol.

[0052] The balloon 10 of the shock wave device 100 of the present invention can be designed as a disposable consumable or a reusable consumable. When it is a reusable consumable, it needs to be disinfected and sterilized before use. In addition, since the shock wave device 100 of the present invention has multiple independent balloons 10, when a balloon is damaged, only the damaged balloon can be replaced without discarding the entire shock wave device, thereby significantly reducing the maintenance cost of the shock wave device.

[0053] Electrode assembly 30

[0054] Figure 5 An example of an electrode assembly of the present invention is shown. Figure 5 As shown, in one embodiment of the present invention, the electrode assembly 30 includes an inner electrode 301 , an insulating layer 302 , a first conductor 303 and an outer electrode 304 .

[0055] The inner electrode 301 is a first electrode, which is disposed in the innermost layer of the electrode assembly 30 and is electrically connected to the power supply unit through a wire of the electrode cable 21. There is no particular restriction on the material constituting the inner electrode 301, and it can be any conductor, but preferably a metal material such as copper, silver, tungsten, etc. There is no particular restriction on the shape of the inner electrode 201, but if Figure 5 As shown, the cross section of the rod-shaped internal electrode 301 is preferably a rod-shaped electrode with a circular cross section. The diameter of the rod-shaped internal electrode 301 is 0.1 to 1.0 mm, preferably 0.1 to 0.5 mm.

[0056] The insulating layer 302 covers at least a portion of the outer circumference of the inner electrode 301, so that the end of the inner electrode 301 is exposed from the end of the insulating layer 302. The end of the inner electrode 301 can be aligned with the end of the insulating layer 302, or, alternatively, the end of the inner electrode 301 can protrude from the end of the outer insulating layer 302. There is no particular limitation on the material constituting the insulating layer 302, and it can be any insulator, but it is preferably a high-voltage resistant material such as polyimide or polytetrafluoroethylene. There is no particular limitation on the shape of the insulating layer 302, but if Figure 5As shown, the insulating sheath preferably has a circular cross-section covering the outer peripheral surface of the inner electrode 301. The wall thickness of the circular insulating sheath is 0.1-1.0 mm, preferably 0.2-0.5 mm. There is no particular limitation on the length of the inner electrode 301 exposed from the far end of the insulating layer 302.

[0057] The first conductor 303 is disposed at the end of the insulating layer 302 and covers at least a portion of the outer peripheral surface of the insulating layer 302. The first conductor is not electrically connected to the power supply unit, so it does not have any polarity. There is no particular restriction on the material constituting the first conductor 303, and it can be any conductor, but preferably a metal material such as stainless steel or copper. There is no particular restriction on the shape of the first conductor 303, but if Figure 5 As shown, it is preferably in a ring shape covering the outer peripheral surface of the end of the insulating layer 302. The thickness of the ring-shaped first conductor 303 is 0.1 to 1.0 mm.

[0058] The outer electrode 304 is provided at the base end of the insulating layer 302 relative to the first conductor 303, and is spaced a distance from the first conductor 303 and covers at least a portion of the outer peripheral surface of the insulating layer 302. The outer electrode 304 is a second electrode, which is electrically connected to the power supply unit through a conductor of the electrode cable 21. There is no particular restriction on the material constituting the outer electrode 304, but it is preferably a metal material such as stainless steel or copper. There is no particular restriction on the shape of the outer electrode 304, but if Figure 5 As shown in FIG. 3 , the outer electrode 304 preferably has an annular shape covering the outer peripheral surface of the base end of the insulating layer 302. The thickness of the annular outer electrode 304 is 0.1 to 1.0 mm. Figure 5 As shown, there is an insulating gap between the first conductor 303 disposed on the outer peripheral surface of the outer insulating layer 302 and the outer electrode 304 .

[0059] According to the electrode assembly 30 as described above, when a voltage is applied between the inner electrode 301 and the outer electrode 304, a pressure difference is formed between the inner electrode 301 and the outer electrode 304, and according to the series voltage division principle, a pressure difference also exists in the gap between the end of the inner electrode 301 and the first conductor 303 (first discharge point) and the gap between the first conductor 303 and the outer electrode 304 (second discharge point). Due to the existence of the above-mentioned pressure difference, the dielectrics at the first discharge point and the second discharge point are simultaneously broken down and release shock wave energy. The shock wave generated at the first discharge point (the head end of the electrode assembly 30) is radially transmitted along the axial direction of the electrode assembly 30, while the shock wave generated at the second discharge point is radially transmitted along the radial direction of the electrode assembly 30.

[0060] The above-mentioned discharge and shock wave conduction method can achieve satisfactory results when used to treat more serious heart valve and vascular calcification, especially severe heart valve calcification. When a heart valve is severely calcified, it will be difficult for the balloon of the shock wave device to enter the valve ring and open the valve. Therefore, when using a shock wave device with the electrode assembly 30 of the present invention, the shock wave generated at the first discharge point is conducted forward along the axial direction of the electrode assembly 30, which can pre-expand the severely calcified valve and make it easier for the balloon to enter the valve ring. When the balloon of the shock wave device completely enters the valve ring, the shock wave generated by the second discharge point and conducted along the radial direction of the electrode assembly 30 can have a further effect on the calcified lesions. Therefore, the electrode assembly 30 of the present invention can achieve more satisfactory results when treating subjects with severe heart valve calcification.

[0061] exist Figure 5 In the electrode assembly 30 shown, the discharge gap (discharge distance) D1 at the first discharge point is fixed, and the size of D1 is approximately the wall thickness of the insulating layer 302. The discharge gap at the second discharge point is D2. There is no particular restriction on the size of D2, but the sum of D1 and D2, that is, the total discharge gap D (D = D1 + D2) should be less than the maximum distance D that can be broken down by the actual working voltage. max For example, with pure water as the medium, when the voltage is 6kV, D max is about 1mm. According to the electrode assembly 30 of the present invention, since D1 is fixed, when D2 is increased, the total discharge gap is also increased accordingly, so that the intensity of the shock wave generated at the second discharge point can be enhanced. In one embodiment of the present invention, the length of D2 is greater than the length of D1, so that more energy can be applied to the calcified lesion. In one embodiment of the present invention, D2 can be appropriately pre-adjusted according to the degree of calcification of the heart valve or blood vessel of the treatment object. In another embodiment of the present invention, the size of D2 can be adjusted according to actual needs during surgery to achieve the best treatment effect. For example, during pre-expansion, D2 can be reduced to less than D1 so that the energy is concentrated at the first discharge point; and when the balloon enters the valve annulus, D2 can be increased so that D2>D1, so that more energy is concentrated at the second discharge point. There is no particular limitation on the specific method of adjusting D2. For example, the outer electrode 304 can be connected to the valve annulus via an insulating guide wire (not shown in the figure) such as Figure 2 The control device at the handle of the base end of the shock wave device is connected, so that the outer electrode 304 can be moved through the guide wire and the control device to adjust the size of D2. In one embodiment of the present invention, D2 is 0.2mm-0.9mm, preferably 0.2mm-0.5mm.

[0062] In one embodiment of the present invention, the outer electrode 304 and / or the first electrical conductor 303 may have a protrusion 309. Fig. 6A As shown, the protrusion 309 of the external electrode 304 extends from the end of the external electrode 304 along the outer surface of the insulating layer 302 toward the first conductor 303, but does not contact the first conductor 303. In another embodiment of the present invention, the first conductor 303 may have a protrusion 309 (not shown in the figure) extending from the base end of the first conductor 303 along the outer surface of the insulating layer 302 toward the external electrode 304, but does not contact the external electrode 304. In another embodiment of the present invention, the first conductor 303 and the external electrode 304 may have protrusions 309 respectively. The provision of the protrusion 309 makes the discharge gap D2 at the second discharge point no longer uniform in the entire circumferential direction of the electrode assembly 30. Specifically, at the position where the protrusion 309 is provided, D2 will become smaller, and therefore the discharge will also occur between the protrusion 309 and the corresponding first conductor 303 / external electrode 304, rather than randomly occurring at the entire second discharge point. The electrode assembly 30 according to the above structure can control the release and conduction direction of the shock wave, and thus can better cooperate with the shock wave device with multiple balloons of the present invention to realize directional release of the shock wave, thereby further improving the quality effect. There is no particular limitation on the shape of the protrusion 309.

[0063] In one embodiment of the present invention, when a shock wave device having multiple balloons is used, preferably, at least one electrode assembly 30 is disposed inside each balloon 10. More preferably, the electrode assembly 30 inside each balloon has a protrusion 309. Still more preferably, the protrusion of each electrode assembly 30 is disposed on the side of the second discharge point that faces the shock wave device in contact with the calcified lesion.

[0064] In one embodiment of the present invention, the inner electrode 301 can move inside the insulating layer 302 along the axial direction of the insulating layer 302. For example, the inner electrode 301 can be connected to a control device at a handle (not shown) at the base end of the shock wave device via an insulating guide wire (not shown in the figure), so that the inner electrode 301 can be moved through the guide wire and the control device.

[0065] In one embodiment of the present invention, Figure 6BAs shown, the end of the movable inner electrode 301 has a connecting portion 310. Preferably, the connecting portion 310 can be in contact with the end of the first conductor 303 during the movement of the inner electrode 301, so that the inner electrode 301 and the first conductor 303 are electrically connected. According to the electrode assembly 30 of the above structure, when the pre-expansion is completed and the balloon enters the valve ring, the head end (first discharge point) of the electrode assembly 30 is no longer required to discharge. At this time, the discharge at the first discharge point is cancelled by electrically connecting the inner electrode 301 and the first conductor 303 as described above, so that the discharge will only occur at the second discharge point. Therefore, the calcified lesions of the heart valve can be treated more effectively. There is no special limitation on the specific shape of the connecting portion 310, as long as the electrical connection between the inner electrode and the first conductor 303 can be achieved as described above.

[0066] In one embodiment of the present invention, Fig. 7A As shown, in addition to the first conductor 303, the electrode assembly 30 may further include at least one second conductor 305. The second conductor 305 is disposed between the first conductor 303 and the external electrode 304. When two or more second conductors 305 are provided, the second conductors 305 are arranged at intervals between the first conductor 303 and the external electrode 304.

[0067] The first conductor 303 and the second conductor 305 (hereinafter sometimes collectively referred to as conductors) are not electrically connected to the power supply unit and therefore do not have any polarity. There is no particular restriction on the material constituting the second conductor 305, and it can be any conductor, but preferably a metal material such as stainless steel or copper. There is no particular restriction on the shape of the second conductor 305, and the shapes of the first conductor 303 and the second conductor 305 can be the same or different. However, preferably, as Fig. 7A As shown, the shape of the second conductor 305 is preferably a ring shape covering a portion of the outer peripheral surface of the insulating layer 302. The wall thickness of the ring-shaped second conductor is 0.1-1.0 mm. There is no limitation on the specific number of the second conductors 305 in the electrode assembly 30. However, preferably, the number of the second conductors 305 of the electrode assembly 30 is 1 to 4, more preferably 1 to 2.

[0068] like Fig. 7A As shown, there is an insulating gap between the first conductor 303 and the adjacent second conductor 305 , there is an insulating gap between the outer electrode 304 and the adjacent second conductor 305 , and there is an insulating gap between any two adjacent second conductors 305 .

[0069] In one embodiment of the present invention, Figure 7BAs shown, at least one second electrical conductor 305 may have a protrusion 309. The protrusion 309 of the second electrical conductor 305 is arranged in a manner similar to the protrusions of the first electrical conductor 303 and the external electrode 304, that is, it extends from one end of the second electrical conductor 305 along the outer circumference of the insulating layer 302 to the base end or the end of the insulating layer 302, but does not contact the adjacent first electrical conductor 303 / second electrical conductor 305 / external electrode 304.

[0070] According to the electrode assembly 30 of the present invention, when treating subjects with heart valve and vascular calcification, especially those with severe heart valve calcification, the balloon of the shock wave device can be easily entered into the valve annulus through pre-expansion, and the head end discharge of the electrode assembly 30 can be cancelled after the balloon enters the valve annulus, thereby concentrating the energy on the treatment of the calcified lesions.

[0071] In one embodiment of the present invention, the shock wave device 100 includes a circuit control system 40 for controlling the shock wave transmitter 20. Figure 8 As shown in the dashed box, the circuit control system 40 of the shock wave device of the present invention includes a control unit 401 , a high voltage isolation unit 402 and a multi-channel control unit 403 .

[0072] The control unit 401 is controlled by a single-chip program software delay or a hardware timer circuit. Multiple output pins correspond to multiple electrodes respectively, and can send low-level, high-level or PWM signals to control the switch components in the multi-channel control unit 403.

[0073] The high-voltage isolation unit 402 is also called a high-voltage isolation circuit. Since the working voltage of the electrode during discharge is 1 to 20 kV, strong peak voltage / current and electromagnetic interference will be generated during discharge. The working voltage of the control unit 401 is only 3 to 5 V, and the anti-interference ability is poor. In addition, the driving voltage / current of the high-voltage switching device is large, and the signal output by the single-chip microcomputer cannot be driven directly, and the driving signal needs to be boosted before control. The high-voltage isolation circuit 403 can use devices such as optocouplers to enhance the output signal driving capability of the single-chip microcomputer of the control unit, while ensuring effective isolation of the control circuit and the load circuit, isolating the digital signal from the analog signal, and avoiding interference of the high-voltage load circuit with the control circuit.

[0074] The multi-channel control unit 403 is also called a multi-channel independent control switch, which is used to control the on and off of the circuit. Specific examples of multi-channel independent control switches include but are not limited to high-voltage switching devices such as high-voltage relays, high-voltage thyristors, and high-voltage IGBTs. When the signal output by the control unit 401 is a low level, the switch is disconnected; when the signal output by the control unit 401 is a high level, the switch is closed; when the output signal of the control unit 401 is a PWM signal, the switch is periodically turned on and off. In the multi-channel control unit of the present invention, the components require higher withstand voltage parameters and an overcurrent capability greater than 20A, and the dv / dt should be greater than 7000V / μs to ensure stable switch performance. The high-voltage trigger switch is controlled by the multi-channel control unit 403, and then the electrode assembly 30 is discharged through the high-voltage energy storage capacitor.

[0075] In one embodiment of the present invention, the circuit control system may further include a low-voltage isolation unit 404. The low-voltage isolation unit 404 is also called a low-voltage isolation circuit, and specific examples thereof include digital isolators, etc., which can meet electrical safety standards or reduce noise in ground loops, etc. The low-voltage isolation unit 404 can achieve dual isolation of digital signals and analog signals, while improving the load capacity of the control signal, and reducing or avoiding the impact of multiple optoelectronic isolation components on speed and power consumption.

[0076] According to the circuit control system of the present invention in the above embodiment, multi-channel control can be achieved by using only one boost circuit, thereby reducing the overall volume of the high voltage generator by dozens of times, and the control circuit board only needs a PCB of about 10cm*10cm area.

[0077] In one embodiment of the present invention, according to the actual situation of the treatment object, the shock wave emitters 20 in the multiple balloons 10 can be controlled separately during the operation to generate shock waves of different intensities; the filling degrees of the multiple balloons 10 can be controlled separately to control the intensities of the shock waves transmitted to the calcified lesions with different degrees of calcification; or a combination of the two can be used to generate / transmit shock waves of different intensities to the calcified lesions with different degrees of calcification.

[0078] Although the above embodiments of the present invention take humans as treatment objects and describe the structure and usage of the shock wave device of the present invention, the treatment objects of the shock wave device of the present invention are not limited to humans, but may also be other animals. For example, the patent object of the shock wave device of the present invention may be pets such as cats and dogs, large animals such as cows and horses, and rare wild animals such as pandas.

[0079] The above descriptions are merely embodiments of the present invention and are not intended to limit the patent scope of the present invention. Any equivalent structure or equivalent process transformation made using the contents of the present invention specification and drawings, or directly or indirectly applied in other related technical fields, are also included in the patent protection scope of the present invention.

Claims

1. An electrode assembly for a shock wave device, the electrode assembly being arranged inside a balloon of the shock wave device, characterized in that: include: a first electrode; an insulating layer, wherein the first electrode is disposed inside the insulating layer and an end of the first electrode is exposed from an end of the insulating layer; a first conductor disposed on at least a portion of an outer peripheral surface of a terminal end of the insulating layer; A second electrode, the second electrode is disposed on at least a portion of the outer peripheral surface of the base end of the insulating layer, so that there is an insulating gap between the second electrode and the first conductor; The first electrode can move inside the insulating layer along the length direction of the insulating layer, and the end of the first electrode has a connecting portion, and the connecting portion electrically connects or disconnects the first electrode and the first conductor as the first electrode moves; The second electrode is movably arranged to adjust the insulation gap between the second electrode and the first conductor.

2. The electrode assembly according to claim 1, characterized in that: At least one of the first conductor and the second electrode has a protrusion extending from one of the first conductor and the second electrode toward the other of the first conductor and the second electrode along the outer peripheral surface of the insulating layer.

3. The electrode assembly according to claim 1 or 2, characterized in that: It also includes at least one second conductor, which is arranged on at least a portion of the outer peripheral surface of the insulating layer and is located between the first conductor and the second electrode, so that there is an insulating gap between the first conductor and the second conductor and between the second conductor and the second electrode.

4. The electrode assembly according to claim 3, characterized in that: At least one of the second electrical conductors has a protrusion extending from the second electrical conductor along the outer peripheral surface of the insulating layer toward a base end or a terminal end of the insulating layer.

5. The electrode assembly according to claim 4, characterized in that: The first conductor, the second conductor and the second electrode have two or more protrusions in total, and the two or more protrusions are spaced apart by an angle α in the circumferential direction of the insulating layer, α=360° / N, where N is the number of the protrusions.

6. The electrode assembly according to claim 1, characterized in that: The first electrode is a rod-shaped electrode with a diameter of 0.1-1.0 mm.

7. The electrode assembly according to claim 1, characterized in that: The second electrode is a ring electrode with a wall thickness of 0.1-1.0 mm.

8. The electrode assembly according to claim 3, characterized in that: The first conductor and the second conductor are each a ring-shaped conductor with a wall thickness of 0.1 to 1.0 mm.

9. The electrode assembly according to claim 1, characterized in that: The insulating layer is a cylindrical insulating sheath with a wall thickness of 0.1-1.0 mm.

10. A shock wave device, characterized in that: Comprising the electrode assembly according to any one of claims 1 to 9.

11. A shock wave device, characterized in that: The shock wave device comprises two or more balloons, and At least one of the two or more balloons is provided with the electrode assembly according to any one of claims 1 to 9.

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