FIG. 4, each balloon 10 includes a shock wave transmitter 20 which is disposed inside the balloon body of the balloon. Therefore, compared with the shock wave apparatus 900 in the prior art shown in FIG. 1, when the shock wave apparatus 100 of one exemplary embodiment of the present disclosure is in operation state, the distance between the electrode assembly 30 of the shock wave transmitter 20 that generates shock wave and a portion of the outer surface of the balloon 10 that is in contact with the calcification lesion portion is significantly shortened. Therefore, a shock wave generated by a lower voltage/current pulse can maintain sufficient intensity even though the shock wave is conducted to the calcification lesion portion, thereby obtaining a satisfactory therapeutic effect.

In another aspect, since the shock wave apparatus 100 of the present disclosure have a structure described above, that is, the cylindrical balloon bodies of each balloon 10 in the shock wave apparatus 100 are parallel to each other, the balloons are not prone to displacement caused by the slight pressing of a valve when the balloons are in contact with the calcification lesion portion during a surgery, and therefore, a healthcare worker can obtain a satisfactory therapeutic effect only by performing simple positioning operations. The requirement to operation proficiency level of the operator by the shock wave apparatus 100 in the embodiments of the present disclosure is significantly reduced, such that an operator having ordinary intervention surgery experience can proficiently operate the shock wave apparatus 100 of the present disclosure. Therefore, the time for a surgery can be significantly shortened, and a burden to a treatment subject is alleviated, thereby improving the success rate of the surgery, and reducing various types of risks during the surgery.

In another aspect, in one embodiment of the present disclosure, a plurality of balloons 10 are provided, and a gap for passage of blood is provided between or among balloons 10, such that a surgery can be performed in a case of ensuring the blood to flow without blocking, thereby alleviating a burden to a treatment subject caused by the surgery. Specifically, as shown in FIG. 4, after the plurality of balloons 10 (three in the figure) are dilated, an adequate gap is reserved in both a balloon outer-side region and a balloon inner-side region (portion C in FIG. 4). In an exemplary embodiment of the present disclosure as shown in FIG. 4, the shock wave apparatus 100 is provided with three balloons 10. However, in the other embodiments of the present disclosure, there may be two, four or more balloons 10.

In the shock wave apparatus 100 of an exemplary embodiment of the present disclosure, the diameter of a body portion of a balloon 10 is 2 mm to 12 mm. The diameter of the balloon 10 is preferably 6 mm to 10 mm, and more preferably 8 mm to 10 mm. When the diameter of the balloon is greater than 12 mm, the distance between the electrode assembly and the calcification lesion portion increases, posing a risk of over-attenuation of the intensity of shock wave.

The length of the body portion of the balloon 10 is 20 mm to 60 mm, for example, 20 mm, 35 mm, mm, 55 mm or 60 mm. When the balloon 10 is excessively long, there is a possibility of damage to heart tissue during the surgery, and it is too difficult for the shock wave apparatus to pass a bend when being delivered during the intervention surgery. On the other hand, when the balloon 10 is excessively short, it will be more difficult for operator to position the shock wave apparatus during the surgery.

The fluid which is used in the shock wave apparatus 100 and is injected into the balloon 10 is not specifically limited. The liquid may be an electrolyte liquid, for example, normal saline, etc., or the liquid may also be a non-electrolyte liquid, for example, glycerinum, etc.

The balloon 10 of the shock wave apparatus 100 of the present disclosure may be designed as a disposable consumable or a consumable that can be repeatedly used. When the balloon is the consumable that can be repeatedly used, disinfection and sterilization are required before using it. Moreover, the shock wave apparatus 100 of the present disclosure is provided with a plurality of separate balloons 10, and therefore, when one balloon is broken, it is possible to replace the broken balloon only, instead of discarding the entire shock wave apparatus, thereby significantly reducing the cost of a maintenance fee of the shock wave apparatus.

Electrode Assembly 30

FIG. 5 shows an exemplary example of the electrode assembly of the present disclosure. As shown in FIG. 5, in one exemplary embodiment of the present disclosure, the electrode assembly 30 comprises an inner electrode 301, an insulating layer 302, a first electrical conductor 303 and an outer electrode 304.

The inner electrode 301 is a first electrode, which is disposed on the innermost layer of the electrode assembly 30, and is electrically connected to a power supply unit by means of a wire of the electrode cable 21. The material forming the inner electrode 301 is not specifically limited, may be any electrical conductor, but is preferably metal materials such as copper, silver, tungsten, etc. The shape of the inner electrode 201 is not specifically limited. However, as shown in FIG. 5, the inner electrode preferably has a rod shape with a circular cross section. The diameter of the rod-shaped inner electrode 301 is 0.1 mm to 1.0 mm, and preferably 0.1 mm to 0.5 mm.

The insulating layer 302 covers at least a portion of an outer peripheral surface of the inner electrode 301, such that a terminal end of the inner electrode 301 is exposed from a terminal end of the insulating layer 302. The terminal end of the inner electrode 301 may also be aligned with the terminal end of the insulating layer 302, alternatively, the terminal end of the inner electrode 301 may protrude from the terminal end of the outer insulating layer 302. The material forming the insulating layer 302 is not specifically limited and may be any insulator, but is preferably high-voltage resistant material such as polyimide or polytetrafluoroethylene. The shape of the insulating layer 302 is not specifically limited, as shown in FIG. 5, while is preferably an insulating sheath that covers the outer peripheral surface of the inner electrode 301 and has an annular cross section. The wall thickness of the annular insulating sheath is 0.1 mm to 1.0 mm, and preferably 0.2 mm to 0.5 mm. The length of the inner electrode 301 that is exposed from the distal end of the insulating layer 302 is not specifically defined.

The first electrical conductor 303 is disposed at the terminal end of the insulating layer 302 and covers at least a portion of the outer peripheral surface of the insulating layer 302. The first electrical conductor is not electrically connected to the power supply unit, and thus does not have any polarity. The material for forming the first electrical conductor 303 is not specifically limited, may be any conductor, but is preferably metal materials such as stainless steel, copper, etc. The shape of the first electrical conductor 303 is not specifically limited. However, as shown in FIG. 5, the first electrical conductor preferably has an annular shape that covers the outer peripheral surface of the terminal end of the insulating layer 302. The wall thickness of the annular first electrical conductor 303 is 0.1 mm to 1.0 mm.

Compared to the first electrical conductor 303, the outer electrode 304 is disposed at the base end of the insulating layer 302 spaced apart from the first electrical conductor 303 by a certain distance, 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 by means of one wire of the electrode cable 21. The material for forming the outer electrode 304 is not specifically limited, but is preferably metal materials such as stainless steel, copper, etc. The shape of the outer electrode 304 is not specifically limited, as shown in FIG. 5, while preferably has an annular shape that covers the outer peripheral surface of the base end of the insulating layer 302. The wall thickness of the annular outer electrode 304 is 0.1 mm to 1.0 mm. As shown in FIG. 5, an insulating gap is provided between the first electrical conductor 303 and the outer electrode 304 which are disposed on the outer peripheral surface of the insulating layer 302.

Based on the described electrode assembly 30, when a voltage is applied between the inner electrode 301 and the outer electrode 304, due to a voltage difference formed between the inner electrode 301 and the outer electrode 304 and according to voltage dividing principle in series circuits, voltage differences also exist in a gap (a first discharge point) between the terminal end of the inner electrode 301 and the first electrical conductor 303 and in a gap (a second discharge point) between the first electrical conductor 303 and the outer electrode 304. Mediums at the first discharge point and the second discharge point are broken down at the same time and shock wave energy is generated due to the presence of above voltage differences. Shock wave energy generated at the first discharge point (a head end of the electrode assembly 30) is radially conducted in an axial direction of the electrode assembly 30, while shock wave energy generated at the second discharge point is radially conducted in a radial direction of the electrode assembly 30.

Satisfactory effects can be obtained when the manner of discharge and shock wave conduction described above is used for treating severer cardiac valve and blood vessel calcification, especially severe cardiac valve calcification. When severe calcification occurs at, for example, a cardiac valve, it is difficult for the balloon of the shock wave apparatus to enter into a valvular annulus to dilate the valve. Therefore, when the shock wave apparatus which is provided with the electrode assembly 30 of the present disclosure is used, the shock wave which is generated at the first discharge point is conducted forward in the axial direction of the electrode assembly 30, so as to perform shock wave pre-dilation on a severely calcified valve, such that the balloon easily enters the valvular annulus. When the balloon of the shock wave apparatus completely enters into the valvular annulus, the shock wave which is generated at the second discharge point and is conducted in a radial direction of the electrode assembly 30 can further act on the calcification lesion portion. Therefore, more satisfactory effects can be obtained when the electrode assembly 30 of the present disclosure is used to treat a treatment subject having severe cardiac valve calcification, for example.

In an exemplary example of electrode assembly 30 shown in FIG. 5, a discharge gap (a discharge distance) D₁at the first discharge point is constant, and D₁is approximately the wall thickness of the insulating layer 302. A discharge gap D₂at the second discharge point is not specifically limited. However, the sum of D₁and D₂, i.e., the total discharge gap D (D=D₁+D₂) should be smaller than the maximum distance D_maxthat can be broken down by an actual operation voltage. For example, taking pure water as a medium, D_maxis approximately 1 mm when a voltage is 6 KV. According to the electrode assembly 30 of the present disclosure, since D₁is constant, the total discharge gap increases correspondingly as D₂increases, such that the intensity of shock waves generated at the second discharge point can be enhanced. In one exemplary embodiment of the present disclosure, the length of D₂is greater than the length of D₁, so that more energy are applied on the calcification lesion portion. In one exemplary embodiment of the present disclosure, D₂can be appropriately adjusted in advance according to the degree of calcification of a cardiac valve or a blood vessel of a treatment subject. In another exemplary embodiment of the present disclosure, D₂can be adjusted according to actual needs during a surgery to achieve an optimal therapeutic effect. For example, it is possible to make D₂decrease to be smaller than D₁during pre-dilation, so that energy is concentrated at the first discharge point; and after the balloon enters into a valvular annulus, it is possible to increase D₂to be greater than D₁(D₂>D₁), so that more energy is concentrated at the second discharge point. The specific method for adjusting D₂is not specifically limited. For example, the outer electrode 304 may be connected to a control apparatus at a handle of the shock wave apparatus as shown in FIG. 2 by means of an insulating guide wire (not shown in the figures), such that the outer electrode 304 can be moved by means of the guide wire and the control apparatus, so as to adjust D₂. In one exemplary embodiment of the present disclosure, D₂is 0.2 mm to 0.9 mm, and preferably 0.2 mm to 0.5 mm.

In one exemplary embodiment of the present disclosure, the outer electrode 304 and/or the first electrical conductor 303 may be provided with a protruding part 309. As shown in FIG. 6A, the protruding part 309 of the outer electrode 304 extends from the terminal end of the outer electrode 304 towards the first electrical conductor 303 along the outer surface of the insulating layer 302, but is not contact to the first electrical conductor 303. In another exemplary embodiment of the present disclosure, the first electrical conductor 303 may be provided with a protruding part 309 (not shown in the figures), which extends from the base end of the first electrical conductor 303 towards the outer electrode 304 along the outer surface of the insulating layer 302, but is not contact to the outer electrode 304. In still another embodiment of the present disclosure, each of the first electrical conductor 303 and the outer electrode 304 may be provided with a protruding part 309. By means of the provision of the protruding part 309, the discharge gap D₂at the second discharge point becomes different in the entire circumferential direction of the electrode assembly 30. Specifically, D₂becomes smaller at a position where the protruding part 309 is provided, and therefore, discharge also occurs between the protruding part 309 and the corresponding first electrical conductor 303/outer electrode 304, instead of randomly occurring across the entire second discharge point. According to the electrode assembly 30 of the described structure, the release and conduction directions of shock wave can be controlled, so as to better cooperate with the shock wave apparatus of the present disclosure that is provided with a plurality of balloons and to realize directed release of a shock wave, thereby further improving the quality and effect. The shape of the protruding part 309 is not specifically limited.

In one embodiment of the present disclosure, when the shock wave apparatus which is provided with the plurality of balloons is used, preferably, each balloon 10 is internally disposed with at least one electrode assembly 30. More preferably, the electrode assembly 30 in each balloon is provided with one protruding part 309. Still more preferably, the protruding part of each electrode assembly 30 is disposed at a side of the second discharge point that faces a position where the shock wave apparatus is in contact with the calcification lesion portion.

In one embodiment of the present disclosure, the inner electrode 301 can be moved inside the insulating layer 302 in the axial direction of the insulating layer 302. For example, the inner electrode 301 may be connected to the control apparatus at the handle (not shown in the figures) of the shock wave apparatus through an insulating guide wire (not shown in the figures), such that the inner electrode 301 can be moved by means of the guide wire and the control apparatus.

In one embodiment of the present disclosure, the terminal end of the movable inner electrode 301 is provided with the connecting part 310, as shown in FIG. 6B. Preferably, the connecting part 310 can come into contact with the terminal end of the first electrical conductor 303 during the movement of the inner electrode 301, such that the inner electrode 301 is electrically connected to the first electrical conductor 303. According to the electrode assembly 30 of the described structure, when pre-dilation is completed and the balloon enters into the valvular annulus, the tip end (the first discharge point) of the electrode assembly 30 no longer needs to discharge. At this time, the discharge at the first discharge point is cancelled by means of the above-described electrical connection between the inner electrode 301 and the first electrical conductor 303, and discharge only occurs at the second discharge point. Therefore, the calcification lesion portion of the cardiac valve can be treated more effectively. The shape of the connecting part 310 is not specifically defined, as long as it realizes the above-described electrical connection between the inner electrode and the first electrical conductor 303.

In one embodiment of the present disclosure, in addition to the first electrical conductor 303, the electrode assembly 30 may further be provided with at least one second electrical conductor 305, as shown in FIG. 7A. The second electrical conductor 305 is disposed between the first electrical conductor 303 and the outer electrode 304. When more than two second electrical conductors 305 are provided, the second electrical conductors 305 are arranged at intervals between the first electrical conductor 303 and the outer electrode 304.

The first electrical conductor 303 and the second electrical conductors 305 (hereinafter sometimes collectively referred to as the electrical conductor) are not electrically connected to the power supply unit, and therefore do not have any polarity. The material for forming the second electrical conductor 305 is not specifically limited, may be any conductor, and preferably is metal materials such as stainless steel, copper, etc. The shape of the second electrical conductor 305 is not specifically limited, and the respective shapes of the first electrical conductor 303 and the second electrical conductors 305 may be the same or different. However, preferably, the second electrical conductors 305 have a shape of annular shape that covers a portion of the outer peripheral surface of the insulating layer 302, as shown in FIG. 7A. The wall thickness of each of the annular second electrical conductors is 0.1 mm to 1.0 mm. The number of second electrical conductors 305 in the electrode assembly 30 is not limited. However, preferably, the electrode assembly 30 is provided with one to four second electrical conductors 305, and more preferably one to two of same.

As shown in FIG. 7A, an insulating gap is provided between the first electrical conductor 303 and the second electrical conductor 305 adjacent thereto, an insulating gap is provided between the outer electrode 304 and the second electrical conductor 305 adjacent thereto, and an insulating gap is provided between any two adjacent second electrical conductors 305.

In one exemplary embodiment of the present disclosure, at least one second electrical conductor 30 may be provided with the protruding part 309, as shown in FIG. 7B. The arrangement of the protruding part 309 of the second electrical conductor 305 is similar to the protruding parts of the first electrical conductor 303 and the outer electrode 304, that is, the protruding part 309 extends from an end of the second electrical conductor 305 to the base end or the terminal end of the insulating layer 302 along the outer peripheral surface of the insulating layer 302, but is not in contact with the first electrical conductor 303/second electrical conductor 305/outer electrode 304 adjacent thereto.

According to the electrode assembly 30 of the present disclosure, when a treatment subject having severe cardiac valve and blood vessel calcification, and in particular severe cardiac valve calcification is treated, the balloon of the shock wave apparatus can easily enter into the valvular annulus by means of pre-dilation; moreover, after the balloon enters into the valvular annulus, the discharge of the head end of the electrode assembly 30 may be cancelled, such that energy is concentrated on the treatment of the calcification lesion portion.

Some other exemplary embodiments of the present disclosure will be described below with reference to FIG. 8 to FIG. 12, and for the same or similar components to those of the foregoing exemplary embodiments, details are not described hereinafter again, and differences therebetween are emphasized.

In another exemplary embodiment of the present disclosure, as shown in FIG. 8 and FIG. 9, the shock wave apparatus 100 comprises at least one balloon 10. The balloon 10 is provided with balloon body. Preferably, the balloon body of the balloon 10 is cylindrical after dilated. The shapes of two end parts of the balloon 10 in a lengthwise direction are not specifically defined, as long as the balloon body of the balloon 10 has a shape of cylindrical after being dilated. The balloon 10 of the shock wave apparatus of the present disclosure may also have other shapes.

The balloon 10 is internally disposed with at least one shock wave transmitter which is used for receiving a voltage/current pulse and generating shock wave. The shock wave transmitter comprises at least one electrode cable which receives and conducts a voltage/current pulse and at least one electrode assembly 40 which is electrically connected to the electrode cable and is used for receiving the voltage/current pulse to generate shock wave. The shock wave generated by the electrode assembly 40 is radially conducted to a surface of the balloon 10 through the liquid inside the balloon and is then conducted to the calcification lesion portion through the surface of the balloon.

As shown in FIG. 9, during a surgery, the balloon 10 of the shock wave apparatus 100 is positioned at, for example, a blood vessel. Preferably, the position of the electrode assembly 40 inside the balloon 10 corresponds to the calcification lesion portion, such that the distance between the electrode assembly 40 and the calcification lesion portion is the shortest.

As is shown in FIG. 10A, the electrode assembly 40 comprises an inner insulating layer 401, an inner electrode 402, an outer insulating layer 403, a first electrical conductor 404a and an outer electrode 405.

The inner insulating layer 401 functions as a second insulating layer which is located on the innermost side of the electrode assembly 40, as shown in FIG. 10A. Preferably, the inner insulating layer 401 is an elongated hollow insulator made of an insulating material. The inner insulating layer 401 may be used as a guide cavity so that guide wire(s) or other components of the shock wave apparatus pass through an inner cavity of the inner insulating layer 401. When being used as, for example, the guide cavity, the inner insulating layer 401 may protrude with respect to the other components of the electrode assembly 40, as shown in FIG. 10B. Moreover, when being used as the guide cavity, the inner insulating layer 401 and the balloon 10 are in sealed connection at both ends of the balloon 10. The material for forming the inner insulating layer 401 is not specifically limited, but is preferably a high-voltage resistant material such as polyimide or polytetrafluoroethylene. The shape of an outer insulating layer 403 is not specifically limited, but an insulating sheath with an annular cross section is preferred, as shown in FIG. 10C. The inner diameter of the inner insulating layer 401 shaped into an annular insulating sheath is 0.3 mm to 0.4 mm, and preferably 0.3 mm to mm. The wall thickness of the inner insulating layer 401 is preferably 0.1 mm to 0.2 mm, and more preferably 0.1 mm to 0.15 mm.

When the guide wire(s) or other components of the shock wave apparatus are not required to pass through inside of the inner insulating layer 401, the electrode assembly 40 of the present disclosure may be provided with no inner insulating layer 401.

As shown in FIG. 10A, an inner electrode 402 is disposed on an outer side of the inner insulating layer 401 and covers at least a portion of an outer peripheral surface of a terminal end of the inner insulating layer 401. A terminal end of the inner electrode 402 is exposed from a terminal end of the outer insulating layer (i.e., a first insulating layer) 403. The terminal end of the inner electrode 402 may be aligned with the terminal end of the outer insulating layer 403, or alternatively, the terminal end of the inner electrode 402 may protrude from the terminal end of the outer insulating layer 403. The inner electrode 402 is electrically connected to a power supply unit by means of one wire of an electrode cable. The material for forming the inner electrode 402 is not specifically limited, may be any electrical conductor, but is preferably a metal material such as copper, silver, tungsten, etc. The shape of the inner electrode 402 is not specifically limited, but, as shown in FIG. 10C, the inner electrode 402 is preferably an annular electrode with a circular cross section. The wall thickness of the annular inner electrode 402 is 0.05 mm to 0.2 mm, and preferably 0.1 mm to 0.15 mm.

The outer insulating layer 403 is the first insulating layer and has an elongated hollow structure. Both the inner insulating layer 401 and the inner electrode 402 are located in an interior space of the outer insulating layer 403. Specifically, as shown in FIG. 10A, the inner electrode 402 is disposed in a gap between the inner insulating layer 401 and the outer insulating layer 402. A terminal end of the inner electrode 402 is exposed from the terminal end of the outer insulating layer 403. The terminal end of the inner electrode 402 may be aligned with the terminal end of the outer insulating layer 403, or alternatively, the terminal end of the inner electrode 402 may protrude from the terminal end of the outer insulating layer 403.

The material for forming the outer insulating layer 403 is not specifically limited, and may be any insulator, but is preferably high-voltage resistant material such as polyimide or polytetrafluoroethylene. The shape of the outer insulating layer 403 is not specifically limited, but an insulating sheath with an annular cross section is preferred, as shown in FIG. 10C. The wall thickness of the outer insulating layer shaped into the insulating sheath is 0.1 mm to 0.2 mm, and preferably mm to 0.15 mm. A length of the inner electrode 402 being exposed from a distal end of the outer insulating layer 403 is not specifically limited.

A first electrical conductor 404a is disposed on at least a portion of an outer peripheral surface of the terminal end of the outer insulating layer 403. A terminal end of the first electrical conductor 404a may be aligned with the terminal end of the outer insulating layer 403, or alternatively, the terminal end of the first electrical conductor 404a may protrude from the terminal end of the outer insulating layer 403. However, preferably, the terminal end of the first electrical conductor 404a is aligned with the terminal end of the outer insulating layer 403.

In one exemplary embodiment of the present disclosure, in addition to the first electrical conductor 404a, the electrode assembly 40 is further provided with at least one second electrical conductor 404b. As shown in FIG. 10B, the first electrical conductor 404a is disposed on the outer peripheral surface of the terminal end of the outer insulating layer 403, and the second electrical conductors 404b are sequentially arranged at intervals along a direction directed to the base end of the outer insulating layer 403.

None of the first electrical conductor 404a and the second electrical conductors 404b (hereinafter, collectively referred to as electrical conductors 404 sometimes) is electrically connected to the power supply unit, and therefore none of electrical conductor 404 has any polarity. The material for forming the electrical conductors 404 is not specifically limited, may be any electrical conductor, but is preferably a metal material such as stainless steel, copper, etc. The shape of the electrical conductor 404 is not specifically limited, and the respective shapes of the first electrical conductor 404a and the second electrical conductor 404b may be the same as or different from each other. However, preferably, an annular shape that covers a portion of the outer peripheral surface of the outer insulating layer 403 is preferred, as shown in FIG. 10C. The wall thickness of each of the annular electrical conductors 404 is 0.1 mm to 0.2 mm, and preferably 0.1 mm to 0.15 mm. The specific number of second electrical conductors 404b in the electrode assembly 40 is not limited. However, preferably, the electrode assembly 40 is provided with one to five second electrical conductors 404b, and more preferably two to three of second electrical conductors 404b.

As shown in FIG. 10A and FIG. 10B, compared to the electrical conductors 404, an outer electrode 405 is disposed at the base end of the outer insulating layer 403 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 by means of one wire of the electrode cable. The material forming the outer electrode 405 is not specifically limited, but is preferably a metal material such as stainless steel, copper, etc. The shape of the outer electrode 405 is not specifically limited, but is preferably an annular shape that covers the outer peripheral of the base end of the outer insulating layer 403, as shown in FIG. 10C. The wall thickness of the annular outer electrode 405 is 0.05 mm to 0.2 mm, and preferably 0.1 mm to 0.15 mm.

As shown in FIG. 10A, an insulating gap is provided between the first electrical conductor 404a and the outer electrode 405, which are disposed on the outer peripheral surface of the outer insulating layer 403. Moreover, as shown in FIG. 10B, an insulating gap is provided between the first electrical conductor 404a and the second electrical conductor 404b adjacent thereto, between the outer electrode 405 and the second electrical conductor 404b adjacent thereto, and between any two adjacent second electrical conductors 404b.

In an electrode assembly 40 as shown in FIG. 10A, a discharge principle thereof is basically the same as that of the above-described electrode assembly 30. Specifically, according to voltage dividing principle in series circuits, there are voltage differences at a gap between the terminal end of the inner electrode 402 and a first electrical conductor 404a (a first discharge point), a gap between the first electrical conductor 404a and the second electrical conductor 404b adjacent thereto, a gap between any two adjacent second electrical conductors 404b of the plurality of second electrical conductors 404b and a gap between the second electrical conductor 404b adjacent to the outer electrode 405 and the outer electrode 405 (a plurality of second discharge points). Mediums at the first discharge point and the plurality of second discharge points are broken down at the same time and shock wave energy is generated due to the presence of above voltage differences.

According to the above electrode assembly 40, discharge can be realized at multiple points at the same time. Therefore, compared to a single-point discharge electrode assembly in the prior art, as for the treatment of a treatment subject having blood vessel calcification, and in particular severe coronary vessel calcification which making it difficult for a balloon to enter into a calcification lesion portion, preliminary treatment can be performed on the calcification lesion portion at first by means of discharge of the head end of the electrode assembly 40, such that the calcification lesion portion turns into soft. That is, a pre-dilation function on a vessel with severe calcification can be achieved by the discharge of the head end of the electrode assembly 40, making it easy for the balloon 10 of the shock wave apparatus to enter into the calcification lesion portion smoothly. Shock waves generated at the second discharge points can further act on the calcification lesion portion after the balloon 10 smoothly enters into the calcification lesion portion. Therefore, more satisfactory effects can be obtained when the electrode assembly 40 of the present disclosure is used to treat a treatment subject having, for example, severe coronary vessel calcification.

For the setting of a discharge gap, etc. in the electrode assembly 40 shown in FIG. 10A to FIG. 10C, reference can be made to the above-described electrode assembly 30.

As shown in FIG. 11, in an exemplary embodiment of the present disclosure, the outer electrode 405 and/or the first electrical conductor 404a may be provided with a protruding part 409, similarly to the electrode assembly 30. In addition, any of one or more of the plurality of second electrical conductors 404b may be provided with a protruding part 409. The protruding parts 409 of the second electrical conductors 404b are disposed in a similar manner to the protruding parts of the first electrical conductor 404a and the outer electrode 405, that is, extending from one end of the second electrical conductor 404b to the base end or terminal end of the outer insulating layer 403 along the outer peripheral surface of the outer insulating layer 403, but being not contact with the adjacent first electrical conductor 404a/second electrical conductor 404b/outer electrode 405.

By means of the provision of the protruding parts 409, the discharge gap D₂at the second discharge point 408 becomes different in the entire circumferential direction of the electrode assembly 40. Specifically, D₂becomes smaller at a position where the protruding part 409 is provided, and therefore, discharge also occurs between the protruding part 409 and the corresponding first electrical conductor 404a/outer electrode 405, instead of randomly occurring across the entire second discharge point 408. According to the electrode assembly 40 of the described structure, the release and conduction directions of shock waves can be controlled, and it realizes directed release of shock waves, thereby further improving the quality and effects. The shape of the protruding part 409 is not specifically limited.

The numbers of respective protruding parts of the outer electrode 405 and the plurality of electrical conductors 404, and total number of protruding parts provided on the outer electrode