Electrode for shock wave device and shock wave device for treating heart valve or blood vessel calcification

Abstract

The present invention provides an electrode assembly for a shock wave device, which is arranged inside the balloon of the shock wave device, and is characterized in that it comprises: a first insulating layer, which has a slender hollow structure; an inner electrode; the inner electrode is located inside the first insulating layer; a first conductor, which is arranged on at least a part of the outer peripheral surface of the end of the first insulating layer; and an outer electrode, which is arranged on at least a part of the outer peripheral surface of the base end of the first insulating layer, so that there is an insulating gap between the outer electrode and the first conductor. The electrode assembly 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 of the prior art is mainly composed of a metal conductor and an insulating sheath, and higher energy is often required for the treatment of calcified lesions. 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 pose a great challenge to the life of the shock wave electrode. In addition, in the case of severe calcification of valves or blood vessels, the accommodating space often becomes smaller, making it 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. Summary of the invention

[0005] The present invention provides an electrode assembly for a shock wave device for treating heart valve or blood vessel calcification, the electrode assembly can effectively reduce the attenuation of shock waves during the conduction process, and achieve a satisfactory treatment effect on heart valve or blood vessel 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 in the blood vessel, 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 blood vessel calcification using the shock wave device of the present invention.

[0006] 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:

[0007] A first insulating layer, the first insulating layer having an elongated hollow structure;

[0008] An inner electrode; the inner electrode is located inside the first insulating layer;

[0009] A first conductor provided on at least a portion of an outer peripheral surface of an end of the first insulating layer; and

[0010] An external electrode is provided on at least a portion of an outer peripheral surface of a base end of the first insulating layer so that an insulating gap exists between the external electrode and the first conductor.

[0011] In an electrode assembly according to one aspect of an embodiment of the present invention, at least one of the first conductor and the external electrode has a protrusion extending from one of the first conductor and the external electrode along the outer peripheral surface of the first insulating layer toward the other of the first conductor and the external electrode.

[0012] 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 first insulating layer and is located between the first conductor and the outer electrode, so that there is an insulating gap between the first conductor and the second conductor and between the second conductor and the outer electrode.

[0013] According to an electrode assembly of one aspect of the embodiments of the present invention, the electrode assembly includes two or more second electrical conductors, and an insulating gap is provided between any two adjacent second electrical conductors.

[0014] According to an electrode assembly of one aspect of an embodiment of the present invention, at least one of the second conductors has a protrusion extending from the second conductor along the outer circumference of the first insulating layer toward a base end or a distal end of the first 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 outer 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 first insulating layer, α=360° / N, where N is the number of the protrusions.

[0016] According to an electrode assembly according to one aspect of an embodiment of the present invention, the electrode assembly includes 2 to 5 second electrical conductors.

[0017] According to an electrode assembly of one aspect of an embodiment of the present invention, the inner electrode is movable inside the first insulating layer along the length direction of the first insulating layer, and

[0018] A connecting portion is formed at a distal end of the inner electrode, and the connecting portion electrically connects or disconnects the inner electrode and the first conductor as the inner electrode moves in an axial direction.

[0019] In the electrode assembly according to one aspect of the embodiments of the present invention, the inner electrode is a ring-shaped electrode with a wall thickness of 0.05 to 0.2 mm.

[0020] In the electrode assembly according to one aspect of the embodiments of the present invention, the outer electrode is a ring-shaped electrode with a wall thickness of 0.05 to 0.2 mm.

[0021] In the electrode assembly according to one aspect of an embodiment of the present invention, the first conductor is a ring-shaped conductor with a wall thickness of 0.05 to 0.2 mm.

[0022] In the electrode assembly according to one aspect of an embodiment of the present invention, the first insulating layer is a cylindrical insulating layer with a wall thickness of 0.05 to 0.2 mm.

[0023] In the electrode assembly according to one aspect of the embodiments of the present invention, the second conductor is a ring-shaped conductor with a wall thickness of 0.05 to 0.2 mm.

[0024] The electrode assembly according to one aspect of an embodiment of the present invention further includes a second insulating layer disposed inside the first insulating layer, and the inner electrode is disposed on at least a portion of an outer circumferential surface of an end of the second insulating layer.

[0025] In the electrode assembly according to one aspect of an embodiment of the present invention, the second insulating layer is a cylindrical insulating layer having an inner diameter of 0.3 to 0.4 mm and a wall thickness of 0.1 to 0.2 mm.

[0026] Another aspect of an embodiment of the present invention provides a shock wave device, characterized by comprising the electrode assembly of the present invention.

[0027] Another aspect of an embodiment of the present invention provides a method for treating vascular wall calcification, characterized in that the calcified part of the blood vessel is treated using the shock wave device of the present invention.

[0028] 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

[0029] 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:

[0030] Figure 1 It is a structural schematic diagram of a shock wave device of the prior art;

[0031] Figure 2 is a schematic structural diagram of an embodiment of the shock wave device of the present invention;

[0032] Figure 3 is a schematic diagram of a use state of an embodiment of the shock wave device of the present invention;

[0033] Figures 4A to 4C is a schematic diagram of an embodiment of an electrode assembly for a shock wave device of the present invention;

[0034] Figure 5 is a schematic diagram of an improved example of an electrode assembly for a shock wave device of the present invention; and

[0035] Fig. 6A and 6B It is a schematic diagram of an improved example of the electrode assembly for a shock wave device according to 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 2As shown, a shock wave device 100 of an embodiment of the present invention includes at least one balloon 10. The balloon 10 has a 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 is cylindrical after being filled, the shapes of the two ends of the balloon 10 in the length direction are not specifically limited. The balloon 10 of the shock wave device of the present invention may also have other shapes.

[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, and it can be, for example, 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 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 is arranged inside the balloon 10, and the shock wave transmitter is used to receive voltage / current pulses and generate shock waves. The shock wave transmitter includes at least one electrode cable and at least one electrode assembly 40, and the electrode cable receives and conducts voltage / current pulses. The electrode assembly 40 is electrically connected to the electrode cable and is used to receive voltage / current pulses to generate shock waves. The shock wave generated by the electrode assembly 40 is radially transmitted to the surface of the balloon 10 through the liquid inside the balloon 10, and then transmitted to the calcified lesion through 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, a blood vessel. Preferably, the position of the electrode assembly 40 in the balloon 10 corresponds to the calcified lesion, so that the distance between the electrode assembly 40 and the calcified lesion is the shortest.

[0046] 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.

[0047] 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.

[0048] 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.

[0049] Electrode assembly 40

[0050] Figures 4A to 4C An example of an electrode assembly for a shock wave device of the present invention is shown. Figure 4A The electrode assembly 40 includes an inner insulating layer 401 , an inner electrode 402 , an outer insulating layer 403 , a first conductor 404 a and an outer electrode 405 .

[0051] like Figure 4A As shown, the inner insulating layer 401 is a second insulating layer, which is located at the innermost side of the electrode assembly 40. Preferably, the inner insulating layer 401 is an elongated hollow insulator made of insulating material. The inner insulating layer 401 can be used as a guide cavity to allow the guide wire or other components of the shock wave device to pass through its inner cavity. Figure 4B As shown, when the inner insulating layer 401 is used as a guide cavity, it can protrude relative to other components of the electrode assembly 40. And, when used as a guide cavity, the inner insulating layer 401 is sealed and connected between the two ends of the balloon 10 and the balloon 10. There is no particular restriction on the insulating material constituting the inner insulating layer 401, but it is preferably a high-voltage resistant material such as polyimide or polytetrafluoroethylene. There is no particular restriction on the shape of the outer insulating layer 403, but it can be Figure 4C As shown, the cross section of the insulating sheath is preferably annular. The inner diameter of the inner insulating layer 401 in the shape of annular insulating sheath is 0.3-0.4 mm, preferably 0.3-0.35 mm. The wall thickness of the inner insulating layer 401 is preferably 0.1-0.2 mm, preferably 0.1-0.15 mm.

[0052] When the guide wire or other components of the shock wave device do not need to pass through the interior of the electrode assembly 40 , the electrode assembly 40 of the present invention may not be provided with the inner insulating layer 401 .

[0053] like Figure 4A As shown, the inner electrode 402 is arranged outside the inner insulating layer 401 and covers at least a portion of the outer peripheral surface of the end of the inner insulating layer 401. And the end of the inner electrode 402 is exposed from the end of the outer insulating layer 403. The end of the inner electrode 402 can be aligned with the end of the outer insulating layer 403, or, alternatively, the end of the inner electrode 402 can protrude from the end of the outer insulating layer 403. The inner electrode 402 is electrically connected to the power supply unit via a conductor of the electrode cable. There is no particular restriction on the material constituting the inner electrode 402, and it can be any conductor, but it is preferably a metal material such as copper, silver, tungsten, etc. There is no particular restriction on the shape of the inner electrode 402, but preferably, as Figure 4CAs shown, the inner electrode 402 is a ring-shaped electrode with a circular cross section. The wall thickness of the ring-shaped inner electrode 402 is 0.05-0.2 mm, preferably 0.1-0.15 mm.

[0054] The outer insulating layer 403 is a first insulating layer having an elongated hollow structure, and the inner insulating layer 401 and the inner electrode 402 are both located in the inner space of the outer insulating layer 403. Figure 4A As shown, the inner electrode 402 is disposed in a gap between the inner insulating layer 401 and the outer insulating layer 403. The end of the inner electrode 402 is exposed from the end of the outer insulating layer 403. The end of the inner electrode 402 may be aligned with the end of the outer insulating layer 403, or, alternatively, the end of the inner electrode 402 may protrude from the end of the outer insulating layer 403.

[0055] There is no particular restriction on the material constituting the outer insulating layer 403, and it can be any insulator, but preferably a high voltage resistant material such as polyimide or polytetrafluoroethylene. There is no particular restriction on the shape of the outer insulating layer 403, but if Figure 4C As shown, the insulating sheath is preferably an annular cross section. The wall thickness of the outer insulating layer in the shape of the insulating sheath is 0.1 to 0.2 mm, preferably 0.1 to 0.15 mm. There is no particular limitation on the length of the inner electrode 402 exposed from the distal end of the outer insulating layer 403.

[0056] The first electrical conductor 404a is provided on at least a portion of the outer circumference of the end of the outer insulating layer 403. The end of the first electrical conductor 404a may be aligned with the end of the outer insulating layer 403, or, alternatively, the end of the first electrical conductor 404a may protrude from the end of the outer insulating layer 403. However, preferably, the end of the first electrical conductor 404a is aligned with the end of the outer insulating layer 403.

[0057] In one embodiment of the present invention, in addition to the first conductor 404a, the electrode assembly 40 further has at least one second conductor 404b. Figure 4B As shown, the first conductor 404 a is disposed on the outer peripheral surface of the end of the outer insulating layer 403 , and the second conductors 404 b are arranged in sequence and spaced apart toward the base end of the outer insulating layer 403 .

[0058] The first conductor 404a and the second conductor 404b (hereinafter sometimes collectively referred to as the conductor 404) 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 conductor 404, 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 conductor 404, and the shapes of the first conductor 404a and the second conductor 404b can be the same or different. However, it is preferably as follows: Figure 4CThe annular shape shown covers a portion of the outer peripheral surface of the outer insulating layer 403. The wall thickness of the annular conductor 404 is 0.1 to 0.2 mm, preferably 0.1 to 0.15 mm. There is no limitation on the specific number of the second conductors 404b in the electrode assembly 40. However, preferably, the number of the second conductors 404b of the electrode assembly 40 is 1 to 5, more preferably 2 to 3.

[0059] like Figure 4A and 4B As shown in FIG. 1 , the outer electrode 405 is disposed at the base end of the outer insulating layer 403 relative to the conductor 404 and covers a portion of the outer peripheral surface of the outer insulating layer 403. The outer electrode 405 is electrically connected to the power supply unit through a conductor of the electrode cable. There is no particular restriction on the material constituting the outer electrode 405, 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 405, but it is preferably as follows: Figure 4C The annular shape shown covers the outer peripheral surface of the base end of the outer insulating layer 403. The thickness of the annular outer electrode 405 is 0.05 to 0.2 mm, preferably 0.1 to 0.15 mm.

[0060] like Figure 4A As shown, there is an insulating gap between the first conductor 404a disposed on the outer peripheral surface of the outer insulating layer 403 and the outer electrode 405. Figure 4B As shown, there is an insulating gap between the first conductor 404a and the adjacent second conductor 404b, there is an insulating gap between the external electrode 405 and the adjacent second conductor 404b, and there is an insulating gap between any two adjacent second conductors 404b.

[0061] In such Figure 4A In the electrode assembly 40 shown in FIG. 1 , when a voltage is applied between the inner electrode 402 and the outer electrode 405, a pressure difference is formed between the inner electrode 402 and the first conductor 404a and between the first conductor 404a and the outer electrode 405. Therefore, the dielectric at the gap between the end of the inner electrode 402 and the first conductor 404a disposed at the end of the outer insulating layer 403 (first discharge point) and the gap between the first conductor 404b and the outer electrode 405 is broken down and the shock wave energy is released. Figure 4BIn the electrode assembly 40 shown, when a voltage is applied between the inner electrode 402 and the outer electrode 405, according to the series voltage division principle, there is also a pressure difference between the end of the inner electrode 402 and the first conductor 404a disposed at the end of the outer insulating layer 403 (first discharge point), the gap between the first conductor 404a and the adjacent second conductor 404b, each gap between any two adjacent second conductors 404b among the plurality of second conductors 404b, and the gap between the second conductor 404b adjacent to the outer electrode 405 and the outer electrode 405 (multiple second discharge points). Due to the existence of the above-mentioned pressure difference, the dielectrics at the first discharge point and the plurality of second discharge points 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 40) is radially transmitted along the axial direction of the electrode assembly 40, while the shock waves generated at the plurality of second discharge points are radially transmitted along the radial direction of the electrode assembly 40.

[0062] According to the electrode assembly 40 as described above, multi-point simultaneous discharge can be achieved. Therefore, compared with the electrode assembly of the prior art with single-point discharge, the electrode assembly 40 of the present invention can first discharge through the head end of the electrode assembly 40 to perform preliminary treatment on the calcified lesions and soften the calcified lesions when treating calcified heart valves and blood vessels, especially those with severe calcification of coronary vessels, which makes it difficult for the balloon of the shock wave device to enter the calcified lesions. That is, the discharge at the head end of the electrode assembly 40 can pre-expand the severely calcified blood vessels, making it easier for the balloon 10 of the shock wave device to enter the calcified lesions smoothly. After the balloon 10 successfully enters the calcified lesions, the shock wave generated at the second discharge point can further act on the calcified lesions. Therefore, the electrode assembly 40 of the present invention can achieve more satisfactory results when treating subjects with severe calcification of coronary vessels.

[0063] exist Figures 4A to 4C In the electrode assembly 40 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 outer insulating layer 403. 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 About 1mm. Figure 4AIn the electrode assembly 40 shown, 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 408 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 subject. 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 the pre-expansion period, 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 calcified lesion, D2 can be increased so that D2>D1, so that more energy is concentrated at the second discharge point. For example, the outer electrode 405 can be connected to the control device at the handle (not shown in the figure) at the base end of the shock wave device via an insulating guide wire (not shown in the figure), so that the outer electrode 405 can be moved through the guide wire and the control device, thereby adjusting the size of D2. In one embodiment of the present invention, D2 is 0.2 mm-0.9 mm, preferably 0.2 mm-0.5 mm.

[0064] like Figure 5 As shown, in one embodiment of the present invention, the outer electrode 405 and / or the first conductor 404a may have a protrusion 409. Figure 5 As shown, the protrusion 409 of the external electrode 405 extends from the end of the external electrode 405 along the outer peripheral surface of the outer insulating layer 403 toward the first conductor 404a, but does not contact the first conductor 404a. In another embodiment of the present invention, the first conductor 404a may have a protrusion 409 (not shown) extending from the base end of the first conductor 404a along the outer peripheral surface of the outer insulating layer 403 toward the external electrode 405, but does not contact the external electrode 405. In yet another embodiment of the present invention, the first conductor 404a and the external electrode 405 may each have a protrusion 409.

[0065] like Figure 5 As shown, in one embodiment of the present invention, any one or more of the plurality of second conductors 404b may have a protrusion 409. The protrusion 409 of the second conductor 404b is arranged in a manner similar to the protrusions of the first conductor 404a and the external electrode 405, that is, extending from one end of the second conductor 404b along the outer circumference of the external insulating layer 403 to the base end or the end of the external insulating layer 403, but not in contact with the adjacent first conductor 404a / second conductor 404b / external electrode 405.

[0066] The arrangement of the protrusion 409 makes the discharge gap D2 at the second discharge point 408 no longer uniform in the entire circumferential direction of the electrode assembly 40. Specifically, at the position where the protrusion 409 is arranged, D2 will become smaller, and therefore the discharge will also occur between the protrusion 409 and the corresponding first conductor 404a / external electrode 405, rather than randomly occurring at the entire second discharge point 408. According to the electrode assembly 40 of the above structure, it is possible to control the release and conduction direction of the shock wave, realize the directional release of the shock wave, and further improve the quality effect. There is no particular restriction on the shape of the protrusion 409.

[0067] There is no particular limitation on the number of protrusions 409 of each of the external electrode 405 and the plurality of electrical conductors 404, and the total number of protrusions on the external electrode 405 and the plurality of electrical conductors 404. However, preferably, only one protrusion 409 is provided on any one of the external electrode 405 and the plurality of electrical conductors 404. When the total number of protrusions on the external electrode 405 and the plurality of electrical conductors 404 is 2 or more, when observed from the end of the electrode assembly 40 as shown in 4C, the 2 or more protrusions 409 are evenly distributed on the circumference of the cross section of the electrode assembly 40. That is, for example, when the total number of protrusions 409 is N, the angle α between the N protrusions on the circumference of the cross section of the electrode assembly 40 is 360° / N. Specifically, when N is 2, α is 180°; when N is 3, α is 120°, and so on. There is no particular limitation on the extending direction of the protrusions 409 on the external electrode 405 and the plurality of conductors 404 , but preferably, only one protrusion is provided at each second discharge point.

[0068] In one embodiment of the present invention, the inner electrode 402 can move inside the outer insulating layer 403 along the axial direction of the outer insulating layer 403. There is no particular limitation on the specific method of controlling the movement of the inner electrode 402. For example, the inner electrode 402 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 402 can be moved through the guide wire and the control device.

[0069] In one embodiment of the present invention, Fig. 6AAs shown, the end of the inner electrode 402 also has a connecting portion 410. Preferably, the connecting portion 410 can be in contact with the end of the first conductor 404a during the movement of the inner electrode 402, so that the inner electrode 402 and the first conductor 404a are electrically connected. According to the electrode assembly 40 of the above structure, when the pre-expansion is completed and the balloon enters the calcified lesion of the blood vessel, the head end (first discharge point) of the electrode assembly 40 is no longer required to discharge. At this time, the discharge at the first discharge point is cancelled by electrically connecting the inner electrode 402 and the first conductor 404a as described above, so that the discharge only occurs at the second discharge point. Therefore, the calcified lesion can be treated more effectively. There is no particular limitation on the specific shape of the connecting portion 410, as long as the electrical connection between the inner electrode and the first conductor can be achieved as described above.

[0070] According to the electrode assembly 40 of the present invention, when treating a subject with heart valve and vascular calcification, especially severe vascular wall calcification, the balloon of the shock wave device can be easily entered into the calcified lesion through pre-expansion, and the head end discharge of the electrode assembly 40 can be cancelled after the balloon enters the calcified lesion, thereby concentrating the energy on the treatment of the calcified lesion.

[0071] 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.

[0072] 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 insulating layer, the first insulating layer having an elongated hollow structure; Internal electrode; The inner electrode is located inside the first insulating layer; A first conductor, the first conductor being disposed on at least a portion of an outer peripheral surface of an end of the first insulating layer; as well as an external electrode, the external electrode being disposed on at least a portion of an outer peripheral surface of a base end of the first insulating layer so that an insulating gap exists between the external electrode and the first conductor; At least one second conductor, which is disposed on at least a portion of the outer peripheral surface of the first insulating layer and is located between the first conductor and the external electrode, so that there is an insulating gap between the first conductor and the second conductor and between the second conductor and the external electrode; the second conductors are arranged in sequence and spaced apart toward the base end direction of the first insulating layer; The inner electrode can move inside the first insulating layer along the length direction of the first insulating layer, and a connecting portion is formed at the end of the inner electrode. The connecting portion electrically connects or disconnects the inner electrode and the first conductor as the inner electrode moves axially.

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

3. The electrode assembly according to claim 1 or 2, characterized in that: The electrode assembly includes two or more second electrical conductors, and an insulating gap is provided between any two adjacent second electrical conductors.

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

5. The electrode assembly according to claim 1, characterized in that: The first conductor, the second conductor and the outer 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 first 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 electrode assembly includes 2 to 5 second conductors.

7. The electrode assembly according to claim 1, characterized in that The inner electrode is a ring electrode with a wall thickness of 0.05-0.2 mm.

8. The electrode assembly according to claim 1, characterized in that The outer electrode is a ring electrode with a wall thickness of 0.05-0.2 mm.

9. The electrode assembly according to claim 1, characterized in that The first conductor is a ring-shaped conductor with a wall thickness of 0.05-0.2 mm.

10. The electrode assembly according to claim 1, characterized in that The first insulating layer is a cylindrical insulating layer with a wall thickness of 0.05-0.2 mm.

11. The electrode assembly according to claim 1, characterized in that The second conductor is a ring-shaped conductor with a wall thickness of 0.05-0.2 mm.

12. The electrode assembly according to claim 1, characterized in that The invention also includes a second insulating layer, which is arranged inside the first insulating layer, and the internal electrode is arranged on at least a part of the outer circumference of the end of the second insulating layer.

13. The electrode assembly according to claim 12, characterized in that The second insulating layer is a cylindrical insulating layer with an inner diameter of 0.3-0.4 mm and a wall thickness of 0.1-0.2 mm.

14. A shock wave device, characterized in that: Comprising the electrode assembly according to any one of claims 1 to 13.

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