Shock wave balloon catheter and shock wave system

Abstract

The invention provides a shock wave balloon catheter and a shock wave system. The shock wave balloon catheter is used for being connected to a shock wave controller. The shock wave balloon catheter comprises a balloon, an inner tube and at least two electrodes. A cavity is formed in the balloon. The inner pipe is located in the cavity, and at least one insulating protrusion is arranged on a pipe body of the inner pipe in the radial direction of the inner pipe in an outward protruding mode. The at least two electrodes form at least one electrode pair, each electrode pair comprises two electrodes located on the two opposite sides of the insulating protrusion respectively, the at least two electrodes comprise a positive electrode and a negative electrode, and the positive electrode and the negative electrode are used for being connected to a shock wave controller respectively. Wherein the insulation protrusions and the electrodes are located in the cavity, the two electrodes in each electrode pair are separated through the insulation protrusions, a gap used for generating shock waves is formed between the two electrodes, and the positive electrode and the negative electrode receive trigger signals transmitted by the shock wave controller through the corresponding wires respectively. Shock waves are generated in the gap under the trigger of the trigger signal.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular, to a shock wave balloon catheter and a shock wave system. Background Art

[0002] The liquid-electric effect has very wide applications in the industrial and medical device industries. Currently, in the medical device industry, especially in interventional therapy, the shock waves generated by the liquid-electric effect can crack hard crystalline tissues in the body without harming the flexible tissues of the human body, thus having a very good therapeutic effect on diseases such as stones and calcifications in the body, and therefore having a very broad development prospect.

[0003] Generally, a shock wave balloon catheter can be used to generate shock waves by utilizing the liquid-electric effect and use the shock waves to treat diseases such as stones and calcifications in the body. The electrode pairs in the existing shock wave balloon catheters are usually formed by stacking in the radial direction of the catheter or arranging along the axial direction of the catheter. Among them, for the shock wave balloon catheter formed by stacking electrode pairs in the radial direction, the size in the radial direction is too large, and the overall device cannot be made small enough, which will have more limitations in interventional therapy; while for the shock wave balloon catheter formed by arranging electrode pairs along the axial direction, the distance between the two electrodes will change with the shape of channels such as blood vessels, thus affecting the generation efficiency of shock waves and further affecting the therapeutic effect. Summary of the Invention

[0004] In order to at least partially solve the problems existing in the prior art, according to one aspect of the present invention, a shock wave balloon catheter is provided. The shock wave balloon catheter is used to be connected to a shock wave controller. The shock wave balloon catheter includes a balloon, an inner tube, and at least two electrodes. A chamber is formed inside the balloon. The inner tube is located in the chamber, and at least one insulating protrusion is provided on the tube body of the inner tube protruding outward in the radial direction of the inner tube. At least two electrodes form at least one electrode pair, and each electrode pair includes two electrodes respectively located on opposite sides of the insulating protrusion. At least two electrodes include a positive electrode and a negative electrode, and the positive electrode and the negative electrode are respectively used to be connected to the shock wave controller. Among them, the insulating protrusion and the electrodes are both located in the chamber. The two electrodes in each electrode pair are spaced apart by the insulating protrusion and a gap for generating shock waves is formed between them. The positive electrode and the negative electrode respectively receive the trigger signals transmitted by the shock wave controller through the corresponding wires, and shock waves are generated in the gap under the trigger of the trigger signals.

[0005] The shock wave balloon catheter provided by the present invention is provided with insulating protrusions on the inner tube, which can use the insulating protrusions to position the electrode pair. The insulating protrusions separate the two electrodes in the electrode pair to form a gap. That is to say, the two electrodes in the electrode pair that generates the shock wave are respectively located on both sides of the insulating protrusion. Therefore, the two electrodes that generate the shock wave are not arranged in a radial stack, but are respectively arranged on the inner tube, and the radial dimension of the overall device can be smaller, and the effect of applying to interventional therapy is better. Moreover, both electrodes can partially abut against the insulating protrusion respectively, so the insulating protrusion can fix the size of the gap by positioning the two electrodes. Since the gap is the shock wave generation area, the size of the shock wave generation area can be fixed. No matter how the shock wave balloon catheter moves in a channel, the size of the shock wave generation area will not change. Such a shock wave balloon catheter generates shock waves more stably and has a higher efficiency of generating shock waves. In addition, since the shock wave is stably generated at the gap, the position where the shock wave is generated can be controlled, and such a shock wave balloon catheter also generates shock waves more stably.

[0006] Exemplarily, the wire is attached to the tube body of the inner tube.

[0007] Exemplarily, the electrode pair includes a first electrode and a second electrode. In adjacent electrode pairs, the first electrode is connected to the second electrode in the adjacent electrode pair at the distal end through a wire; along the axial direction of the inner tube, the second electrode of the electrode pair at the proximal end and the first electrode of the electrode pair at the distal end are respectively used to be connected to the shock wave controller through wires; the proximal end is closer to the operator than the distal end.

[0008] Exemplarily, the electrode pair includes a first electrode and a second electrode, and each first electrode and each second electrode are respectively connected to the shock wave controller through wires.

[0009] Exemplarily, there are multiple electrodes, and the multiple electrodes form at least three electrode pairs. The insulating protrusions are at least three. Each electrode pair corresponds to at least one insulating protrusion. The at least three insulating protrusions respectively separate the at least three electrode pairs to form at least three gaps. The coverage angle of the shock waves generated in the at least three gaps in the circumferential direction of the inner tube is not less than 360°.

[0010] Exemplarily, among the at least three electrode pairs, three electrode pairs are arranged in the circumferential direction. The multiple electrodes corresponding to the three electrode pairs are arranged in the circumferential direction, and the three gaps formed by the three electrode pairs are at an angle of 120° to each other in the circumferential direction.

[0011] Exemplarily, the multiple electrodes form at least two electrode groups arranged at intervals along the axial direction of the inner tube. Each electrode group includes at least one electrode pair, and the electrodes corresponding to the electrode pairs in each electrode group are arranged in the circumferential direction.

[0012] Exemplarily, among two adjacent electrode groups, there is a first electrode group located at the proximal end of the inner tube and a second electrode group located at the distal end of the inner tube. The first electrode group or / and the second electrode group includes at least two electrode pairs. The gap formed in the first electrode group and the gap formed in the second electrode group are misaligned in the circumferential direction. The proximal end of the inner tube is closer to the operator than the distal end of the inner tube.

[0013] Exemplarily, multiple electrodes form multiple electrode groups, and the projections of the gaps respectively formed in two electrode groups adjacent to one of the electrode groups overlap in a plane perpendicular to the axial direction.

[0014] Exemplarily, two adjacent electrode groups are the same and are misaligned in the circumferential direction.

[0015] According to another aspect of the present invention, a shock wave system is provided. The shock wave system includes a shock wave controller and any one of the shock wave balloon catheters as described above.

[0016] In the summary of the invention, a series of simplified concepts are introduced, which will be further described in detail in the detailed implementation section. The summary of the invention does not mean to attempt to define the key features and essential technical features of the claimed technical solution, nor does it mean to attempt to determine the protection scope of the claimed technical solution.

[0017] The advantages and features of the present invention will be described in detail below with reference to the accompanying drawings. Description of the Drawings

[0018] The following drawings of the present invention are used as part of the present invention to understand the present invention. The embodiments of the present invention shown in the drawings and their descriptions are used to explain the principles of the present invention. In the drawings,

[0019] Figure 1 is a perspective view of a shock wave balloon catheter according to an exemplary embodiment of the present invention;

[0020] Figure 2 is a front view of a shock wave balloon catheter according to an exemplary embodiment of the present invention;

[0021] Figure 3A is a partial cross-sectional view (one) of a shock wave balloon catheter according to an exemplary embodiment of the present invention;

[0022] Figure 3B is Figure 3A a partial cross-sectional view (two) of the shock wave balloon catheter shown;

[0023] Figure 4A is a partial cross-sectional view (one) of a shock wave balloon catheter according to an exemplary embodiment of the present invention;

[0024] Figure 4B is Figure 4A Partial cross-sectional view (II) of the shock wave balloon catheter shown;

[0025] Figure 5A Partial cross-sectional view (I) of the shock wave balloon catheter according to an exemplary embodiment of the present invention;

[0026] Figure 5B is Figure 5A Partial cross-sectional view (II) of the shock wave balloon catheter shown;

[0027] Figure 6A Partial top view of the shock wave balloon catheter according to an exemplary embodiment of the present invention;

[0028] Figure 6B is Figure 6A Partial bottom view of the shock wave balloon catheter shown;

[0029] Figure 6C is Figure 6A Cross-sectional view of the shock wave balloon catheter shown under section P-P;

[0030] Figure 7A Partial front view of the shock wave balloon catheter according to an exemplary embodiment of the present invention;

[0031] Figure 7B is Figure 7A Partial top view of the shock wave balloon catheter shown;

[0032] Figure 8A Partial front view of the shock wave balloon catheter according to an exemplary embodiment of the present invention;

[0033] Figure 8B is Figure 8A Partial rear view of the shock wave balloon catheter shown;

[0034] Figure 8C is Figure 8A Partial top view of the shock wave balloon catheter shown;

[0035] Figure 9A Partial front view of the shock wave balloon catheter according to an exemplary embodiment of the present invention;

[0036] Figure 9B is Figure 9A Partial rear view of the shock wave balloon catheter shown;

[0037] Figure 10A Partial cross-sectional view (I) of the shock wave balloon catheter according to an exemplary embodiment of the present invention;

[0038] Figure 10B isFigure 10A Partial cross-sectional view (II) of the shock wave balloon catheter shown;

[0039] Figure 11A Partial front view of the shock wave balloon catheter according to an exemplary embodiment of the present invention;

[0040] Figure 11B is Figure 11A Partial rear view of the shock wave balloon catheter shown;

[0041] Figure 11C is Figure 11A Partial top view of the shock wave balloon catheter shown;

[0042] Figure 12A Stereogram of the inner tube according to an exemplary embodiment of the present invention;

[0043] Figure 12B Stereogram of the shock wave balloon catheter according to an exemplary embodiment of the present invention from the front perspective;

[0044] Figure 12C is Figure 12B Stereogram of the shock wave balloon catheter shown from the rear perspective;

[0045] Figure 12D is Figure 12B Stereogram of the shock wave balloon catheter shown from the top-down perspective;

[0046] Figure 13A Partial cross-sectional view of the shock wave balloon catheter according to an exemplary embodiment of the present invention;

[0047] Figure 13B is Figure 13A Partial top view of the shock wave balloon catheter shown;

[0048] Figure 14A Partial cross-sectional view of the shock wave balloon catheter according to an exemplary embodiment of the present invention;

[0049] Figure 14B is Figure 14A Partial top view of the shock wave balloon catheter shown;

[0050] Figure 15A Partial cross-sectional view of the shock wave balloon catheter according to an exemplary embodiment of the present invention;

[0051] Figure 15B is Figure 15A Partial top view of the shock wave balloon catheter shown;

[0052] Figure 16APartial cross-sectional view of a shock wave balloon catheter according to an exemplary embodiment of the present invention;

[0053] Figure 16B is Figure 16A Partial top view of the shock wave balloon catheter shown;

[0054] Figure 17A Partial cross-sectional view of a shock wave balloon catheter according to an exemplary embodiment of the present invention;

[0055] Figure 17B is Figure 17A Partial top view of the shock wave balloon catheter shown;

[0056] Figure 18A Isometric view of an inner tube according to an exemplary embodiment of the present invention; and

[0057] Figure 18B Isometric view of an inner tube according to an exemplary embodiment of the present invention.

[0058] Wherein, the above-mentioned drawings include the following reference numerals:

[0059] 10, shock wave generating device; 110, first electrode; 111, first end face; 1111, first protrusion; 120, second electrode; 121, second end face; 1211, second protrusion; 130, third electrode; 131, third end face; 132, fourth end face; 140, inner tube; 141, insulating protrusion; 1411, breakdown part; 150, gap; 151, sub-gap; 20, shock wave balloon catheter; 210, catheter; 220, balloon; 230, wire; 30, shock wave controller. Detailed Description of the Invention

[0060] In the following description, a large number of details are provided to enable a thorough understanding of the present invention. However, those skilled in the art can understand that the following description only exemplarily shows the preferred embodiments of the present invention, and the present invention can be implemented without one or more of such details. In addition, in order to avoid confusion with the present invention, some well-known technical features in the art are not described in detail.

[0061] In the present application, the "proximal end" can be considered as the end close to the operator, and the "distal end" can be considered as the end far from the operator.

[0062] According to one aspect of the present invention, a shock wave balloon catheter is provided. The shock wave balloon catheter can be applied to any suitable system, including but not limited to a shock wave system. Therefore, according to another aspect of the present invention, a shock wave system is provided. See Figure 1 and Figure 2, the shock wave balloon catheter 20 can be connected to the shock wave controller 30, the shock wave controller 30 can be a high-voltage pulse generating host, and the shock wave controller 30 can have a positive electrode and a negative electrode.

[0063] The shock wave balloon catheter 20 can include a balloon 220, an inner tube 140, and at least two electrodes.

[0064] A chamber can be formed inside the balloon 220. When the shock wave balloon catheter 20 is applied to interventional therapy, the balloon 220 can be placed inside a blood vessel, and the chamber inside the balloon 220 can be filled with a conductive liquid. The conductive liquid filled in the balloon 220 can be a mixed liquid of 50% normal saline and 50% contrast agent, or various other forms of conductive liquid, and this application does not limit this.

[0065] The inner tube 140 can be located inside the chamber, and at least one insulating protrusion 141 can be provided on the tube body of the inner tube 140 and protrude outward along the radial direction of the inner tube 140. The insulating protrusion 141 can be in any form. For example, the insulating protrusion 141 can have an arc-shaped cross-section, a square-like cross-section, or various other forms.

[0066] The at least two electrodes can form at least one electrode pair, and each electrode pair can include two electrodes located on opposite sides of the insulating protrusion 141 respectively. The at least two electrodes can include a positive electrode and a negative electrode, and the positive electrode and the negative electrode are respectively used to connect to the shock wave controller 30. Among them, the positive electrode can be connected to the positive electrode of the shock wave controller 30, and the negative electrode can be connected to the negative electrode of the shock wave controller 30. The at least two electrodes can include a first electrode 110 and a second electrode 120. Here, the first electrode 110 and the second electrode 120 are only for the convenience of description and are not subject to any limitation. For example, the first electrode 110 can be the positive electrode and the second electrode 120 can be the negative electrode, or the first electrode 110 can be the negative electrode and the second electrode 120 can be the positive electrode, or the first electrode 110 and the second electrode 120 may not be connected to the shock wave controller 30 at all. The electrodes can be various forms of conductors. For example, the electrodes can be made of metal materials such as stainless steel, platinum-iridium alloy, nitinol alloy, gold, silver, copper, aluminum, etc., or can be made of non-metal materials such as graphite. Preferably, the electrodes can be made of flexible materials such as graphite through methods such as rolling, cutting, and curling, so as to enhance the flexibility of the shock wave balloon catheter 20.

[0067] The shock wave balloon catheter 20 generally may further include a catheter 210. The inner tube 140 may be integrally formed and connected with the catheter 210. At this time, it can be considered that the inner tube 140 is formed on the catheter 210, and the inner tube 140 may be the part of the catheter 210 located in the chamber; the inner tube 140 may also be sleeved on the catheter 210. For the inner tube 140 sleeved on the catheter 210, since the thickness of the inner tube 140 in the radial direction can be very small, even if the inner tube 140 is sleeved on the catheter 210, the increase in the overall thickness in the radial direction can be negligible. The inner tube 140 may also be separately processed and formed with the catheter 210. The catheter 210 may include at least two sections, and the inner tube 140 may be connected between at least two sections of the catheter 210 in various forms such as welding, clamping or threaded connection. For example, the inner tube 140 may be a shorter tube section, and the inner tube 140 may be one or more. One or more shorter tube sections of the inner tube 140 may be connected between at least two sections of the catheter 210. Among them, both ends of one inner tube 140 may be connected to two sections of the catheter 210, or multiple inner tubes 140 may be connected together first, and both ends of the whole are connected to two ends of the catheter 210. The inner tube 140 may be made of flexible materials such as polyamide, polyether block polyamide, polyimide, polytetrafluoroethylene, and silica gel. The shock wave balloon catheter 20 is generally applied in interventional therapy. Therefore, the inner tube 140 and the catheter 210 in the shock wave balloon catheter 20 are preferably circular in cross section.

[0068] For ease of description, the part of the shock wave balloon catheter 20 for generating shock waves is called the shock wave generating device 10. For example, the shock wave generating device 10 may include an insulating protrusion 141, a part of the inner tube 140 connected to the insulating protrusion 141, and electrodes arranged on this part of the inner tube 140. It is agreed that the axial direction of the inner tube 140 is the direction parallel to the central axis, the circumferential direction of the inner tube 140 (the Y-Y direction shown in the figure) is the direction of rotating around the center of the circle along the outer circumference on the cross section of the inner tube 140, and the radial direction is the direction perpendicular to the circumferential direction Y-Y on the cross section of the inner tube 140, that is, the direction extending along any diameter on the cross section of the inner tube 140.

[0069] Both the insulating protrusion 141 and the electrodes may be located in the chamber. The two electrodes in each pair of electrodes may be spaced apart by the insulating protrusion 141, and a gap 150 for generating shock waves may be formed between them. The electrodes may be respectively connected to the positive or negative pole of the shock wave controller 30. Among them, for specific reference, see Figure 3A and Figure 3B, the two electrodes in each electrode pair are spaced apart by an insulating protrusion 141, and a gap 150 for generating a shock wave is formed therebetween. The electrodes can be abutted against the inner tube 140, or the electrodes can be connected to the inner tube 140 by gluing, welding or other various forms. When the electrodes are welded to the inner tube 140, it can be hot melt welding or laser welding. Each electrode pair includes two electrodes. Taking an electrode pair including a first electrode 110 and a second electrode 120 as an example for illustration. The lengths of the first electrode 110 and the second electrode 120 in the axial direction can be both greater than the length of the insulating protrusion 141 in the axial direction. Thus, the first electrode 110 and the second electrode 120 are spaced apart by the insulating protrusion 141 because they are respectively located on both sides of the insulating protrusion 141. At the same time, a gap 150 will be formed between the part of the first electrode 110 exceeding the insulating protrusion 141 and the part of the second electrode 120 exceeding the insulating protrusion 141 in the axial direction. It should be noted that the meaning that the gap 150 is used to generate a shock wave is that the gap 150 is the gap with the closest distance between the two electrodes in an electrode pair. When the conditions for generating a shock wave are met, a shock wave will be generated at the gap 150. In order to ensure that a shock wave can be generated at the gap 150, the thickness of the insulating protrusion 141 in the radial direction can be not less than the thickness of the electrode in the radial direction, so as to avoid generating a shock wave between the parts of the first electrode 110 and the second electrode 120 exceeding the insulating protrusion 141 in the radial direction. It can be understood that an insulating protrusion 141 located between an electrode pair can generate one or two gaps 150 between this electrode pair. The electrode pair corresponds to the gap 150. Only two electrodes located on both sides of the same insulating protrusion 141 and meeting the following two conditions can be called an electrode pair: First, there is a gap 150 formed by the spacing of the insulating protrusion 141 between the two electrodes; Second, the gap 150 can be used to generate a shock wave, that is, the gap 150 can undergo a breakdown phenomenon under the action of a strong voltage. This application does not limit the correspondence between the electrode pair and the electrodes. For example, Figure 3A and Figure 3B The embodiments shown show embodiments in which two electrodes form an electrode pair. Figure 4A and Figure 4B show embodiments in which six electrodes form four electrode pairs through four insulating protrusions 141. That is to say, one electrode in an electrode pair can also form a new electrode pair with other electrodes. This embodiment will be described in detail below.

[0070] The following will provide a detailed description of how the shock wave balloon catheter 20 generates and utilizes shock waves. For the two electrodes in an electrode pair, one can be connected to the positive pole of the shock wave controller 30, and the other can be connected to the negative pole of the shock wave controller 30. For example, the first electrode 110 can be connected to the positive pole of the shock wave controller 30, and the second electrode 120 can be connected to the negative pole of the shock wave controller 30. The first electrode 110 and the second electrode 120 can be respectively located on opposite sides of the insulating protrusion 141. It can be that the first electrode 110 and the second electrode 120 respectively abut against the opposite sides of the insulating protrusion 141, or the first electrode 110 and the second electrode 120 can be respectively connected to the opposite sides of the insulating protrusion 141 through various forms such as gluing, welding, etc. A gap 150 for generating shock waves is formed by separating the first electrode 110 and the second electrode 120 by the insulating protrusion 141. When the first electrode 110 is connected to the positive pole of the shock wave controller 30 and the second electrode 120 is connected to the negative pole of the shock wave controller 30, the first electrode 110 and the second electrode 120 are respectively located on opposite sides of the insulating protrusion 141. The distance between the first electrode 110 and the second electrode 120 can be considered to be determined by the insulating protrusion 141, that is, the size of the gap 150 can be determined by the insulating protrusion 141. When the shock wave controller 30 transmits a trigger signal, a strong voltage can exist between the first electrode 110 and the second electrode 120. The strong voltage at both ends of the insulating protrusion 141 has no effect on the insulating protrusion 141, but the strong voltage between the first electrode 110 and the second electrode 120 will also act on the gap 150. The strong voltage acting on the gap 150 can cause a breakdown phenomenon at the gap 150. Since the gap 150 is in the conductive liquid environment inside the balloon 220, the breakdown phenomenon will generate bubbles at the gap 150, and these bubbles will rapidly expand and collapse, thereby generating shock waves. The shock waves can be conducted through the balloon 220 to the location of the calcified plaque on or in the blood vessel wall and cause it to crack, thus playing a therapeutic role. The above content actually describes the situation where the first electrode 110 is the positive electrode, the second electrode 120 is the negative electrode, and an electrode pair is formed between the positive and negative electrodes. Among them, the positive and negative electrodes respectively receive the trigger signals transmitted by the shock wave controller 30 through the corresponding wires, and shock waves are generated at the gap under the trigger of the trigger signal. The first electrode 110 may not be the positive electrode, and the second electrode 120 may not be the negative electrode either. However, the first electrode 110 can be connected in series or in parallel with the positive electrode, and the second electrode can be connected in series or in parallel with the negative electrode, so that the gap in the electrode pair formed by the first electrode 110 and the second electrode 120 can generate shock waves. It should be noted that as described above, the first electrode 110 and the second electrode 120 here are only for distinction for the convenience of description and are not subject to any limitations.

[0071] Such as Figure 3A AndFigure 3B In the illustrated embodiment, the insulating protrusion 141 is parallel to the axial direction and perpendicular to the circumferential direction Y-Y. In other embodiments not shown, the insulating protrusion 141 on the inner tube 140 may extend in any direction, for example, the insulating protrusion 141 may extend obliquely around the central axis of the inner tube 140 or may extend in the circumferential direction Y-Y. The present application does not limit the specific form of the insulating protrusion 141. Correspondingly, the two electrodes located on both sides of the insulating protrusion 141 may also have any shape and size, as long as the gap 150 is the gap with the closest distance between the two electrodes.

[0072] For the shock wave balloon catheter 20 provided by the present invention, by providing the insulating protrusion 141 on the inner tube 140, the insulating protrusion 141 can be used to position the electrode pair. The insulating protrusion 141 separates the two electrodes in the electrode pair to form a gap 150. That is to say, the two electrodes in the electrode pair that generate shock waves are respectively located on both sides of the insulating protrusion 141. Therefore, the two electrodes that generate shock waves are not arranged in a radial stack, but are respectively arranged on the inner tube 140, and the radial dimension of the overall device can be smaller, and the effect applied to interventional therapy is better. Moreover, both electrodes can partially abut against the insulating protrusion 141 respectively. Therefore, the insulating protrusion 141 can fix the size of the gap 150 by positioning the two electrodes. Since the gap 150 is the shock wave generation area, the size of the shock wave generation area can be fixed. No matter how the shock wave balloon catheter 20 moves in a channel, the size of the shock wave generation area will not change. Such a shock wave balloon catheter 20 generates shock waves more stably and has a higher efficiency of generating shock waves. In addition, since the shock wave is stably generated at the gap 150, the shock wave generation position can be controlled, and such a shock wave balloon catheter 20 generates shock waves more stably.

[0073] In an embodiment of the present invention, the wire can be attached to the tube body of the inner tube 140. That is to say, on any cross-section of the shock wave balloon catheter 20, there is always a gap on the outer peripheral side of the inner tube 140 where the wire can be arranged. For example, on the outer peripheral side of the inner tube 140, the electrodes and the insulating protrusion 141 do not cover the entire outer peripheral side of the inner tube 140. In this way, the thickness of the shock wave balloon catheter 20 in the radial direction can be smaller, it is easier to move in small blood vessels, and it is more suitable for application in interventional therapy, and the treatment effect applied to interventional therapy is also better.

[0074] In an embodiment of the present invention, see Figure 4A and Figure 4B, at least two electrodes may include a first electrode 110, a second electrode 120, and a third electrode 130. The third electrode 130 may be located between the first electrode 110 and the second electrode 120. The first electrode 110 may have a first end face 111, the second electrode 120 may have a second end face 121, the third electrode 130 may have a third end face 131 close to the first end face 111 and a fourth end face 132 close to the second end face 121. The third end face 131 and the first end face 111 may be spaced apart by at least one insulating protrusion 141 and a gap 150 is formed therebetween; the fourth end face 132 and the second end face 121 may be spaced apart by at least one insulating protrusion 141 and a gap 150 is formed therebetween. Exemplarily, the first electrode 110 may be connected to the positive electrode of the shock wave controller 30, the second electrode 120 may be connected to the negative electrode of the shock wave controller 30, and the third electrode 130 may not be connected to the external shock wave controller 30. After the shock wave controller 30 is turned on, there is a voltage between the first end face 111 of the first electrode 110 and the third end face 131 of the third electrode 130. A current from the third end face 131 to the fourth end face 132 may be formed on the third electrode 130. Thus, there is also a voltage between the fourth end face 132 of the third electrode 130 and the second end face 121 of the second electrode 120. Accordingly, there is a voltage across the gap 150 between the first end face 111 of the first electrode 110 and the third end face 131 of the third electrode 130, and there is also a voltage across the gap 150 between the fourth end face 132 of the third electrode 130 and the second end face 121 of the second electrode 120. Breakdown may occur in both of these gaps 150 to generate shock waves. In such a shock wave balloon catheter 20, three electrodes in one shock wave generating device 10 may form two electrode pairs by using two insulating protrusions 141, and shock waves may be generated at both of the two gaps 150. In this way, the coverage range of the generated shock waves may be wider and the coverage angle may be larger. Moreover, the sizes and positions of these two gaps 150 are determined by the insulating protrusions 141. Not only do the sizes and positions of these two gaps 150 not change themselves, but the relative positions between the two gaps 150 also do not change, which makes the shock waves generated by the shock wave generating device 10 more stable.

[0075] Generally, when the shock wave balloon catheter 20 moves in a curved channel, for example, when the shock wave balloon catheter 20 moves in a curved channel similar to a blood vessel, relative displacement in the axial direction is likely to occur between the electrodes on the concave side of the bend and the electrodes on the convex side of the bend, causing changes in the gap size and position for generating shock waves, thereby changing the efficiency of generating shock waves. In the shock wave balloon catheter 20 provided by the present invention, although the size and position of the gap 150 are determined by the insulating protrusions 141, to further ensure that the size and position of the gap 150 are not likely to change, exemplarily, the first electrode 110, the second electrode 120, and the third electrode 130 may be arranged along the circumferential direction Y-Y of the inner tube 140, and the insulating protrusions 141 may be parallel to the axial direction of the inner tube 140. The gap 150 formed between the first end face 111 and the third end face 131 is parallel to the axial direction of the inner tube 140, and the gap 150 formed between the second end face 121 and the fourth end face 132 is parallel to the axial direction of the inner tube 140. When such a shock wave generating device 10 moves on a curved and winding path, for example, when the shock wave generating device 10 moves in a curved channel similar to a blood vessel, relative displacement in the axial direction is not likely to occur between the first electrode 110, the second electrode 120, and the third electrode 130, and the relative positions of the first electrode 110, the second electrode 120, and the third electrode 130 are not likely to change either. The size and position of the gap 150 formed between the first end face 111 and the third end face 131 and the size and position of the gap 150 formed between the second end face 121 and the fourth end face 132 are not likely to change either. The shock wave balloon catheter 20 can generate shock waves more stably and has a better effect in interventional therapy.

[0076] The first electrode 110, the second electrode 120, and the third electrode 130 are only for distinction and are not specially limited. The number of the first electrode 110, the second electrode 120, and the third electrode 130 can also be arbitrary. In an embodiment of the present invention, refer to Figure 4A and Figure 4B , taking the first electrode 110, the second electrode 120, and the third electrode 130 as described above as an electrode group, the inner tube 140 may include two electrode groups, and among them, the four insulating protrusions 141 may be arranged at intervals of 90° one by one. By reasonably arranging the electrodes and the insulating protrusions in the circumferential direction Y-Y, the coverage angle of the generated shock waves can be made not less than 360°.

[0077] In an embodiment of the present invention, refer to Figure 4A and Figure 4B, there can be multiple electrodes, and the multiple electrodes can form at least three electrode pairs. The insulating protrusions 141 can be at least three. Each electrode pair can correspond to at least one insulating protrusion 141. The at least three insulating protrusions 141 can respectively space apart the at least three electrode pairs to form at least three gaps 150. The coverage angle of the shock waves generated in the at least three gaps 150 in the circumferential direction of the inner tube 140 can be not less than 360°. That is to say, through reasonable arrangement of the at least three gaps 150, the shock waves generated therein can cover the entire circumference in the circumferential direction. When the shock wave balloon catheter 20 is in a blood vessel, when the generated shock waves cover the entire circumference, the calcified plaques on the entire circumference of the blood vessel wall can be treated simultaneously, without the need to adjust the angle multiple times and repeat the treatment multiple times, and the treatment efficiency is naturally higher.

[0078] In an embodiment of the present invention, refer to Figure 5A and Figure 5B , among the at least three electrode pairs, three electrode pairs can be arranged in the circumferential direction. The multiple electrodes corresponding to the three electrode pairs can be arranged in the circumferential direction, and the included angles between the three gaps 150 formed corresponding to the three electrode pairs in the circumferential direction can be 120°. For a shock wave generating device 10 in the shock wave balloon catheter 20, two first electrodes 110, two second electrodes 120, and one third electrode 130 are provided on the inner tube 140, as well as three insulating protrusions. Among them, one first electrode 110, one second electrode 120, and one third electrode 130 form an electrode group. The electrode group includes two electrode pairs and can generate shock waves at the two gaps 150 spaced apart by the two insulating protrusions 141; the remaining one first electrode 110 and the remaining one second electrode 120 can form an electrode pair and can generate shock waves at the gap 150 spaced apart by the remaining one insulating protrusion 141. In such a shock wave generating device 10, three gaps 150 are realized with a relatively small number of electrodes, and the coverage range of the generated shock waves has an angle not less than 360° in the circumferential direction Y-Y through the three gaps 150. For example, the three insulating protrusions 141 can be arranged at intervals of 120° in the circumferential direction Y-Y. Such a shock wave generating device 10 realizes a coverage range angle of the shock waves not less than 360° with a simpler structure.

[0079] The shock wave balloon catheter 20 can achieve that the coverage range of the generated shock waves can cover the entire circumference by only providing one shock wave generating device 10. In an embodiment of the present invention, refer to Figure 6A , Figure 6B and Figure 6CAs shown in the figure, a shock wave generating device 10 is shown on a shock wave balloon catheter 20. Since the coverage angle of the shock waves generated by this shock wave generating device 10 in the circumferential direction is not less than 360°, even if only such a shock wave generating device 10 is provided in the shock wave balloon catheter 20, a good treatment effect can be achieved, and the overall structure can be very simple. Taking a first electrode 110, a second electrode 120, and a third electrode 130 as an electrode group, the illustrated embodiment includes two electrode groups, which are respectively Figure 6C the first electrode group I located in the upper left corner in Figure 6C and the second electrode group II located in the lower right corner in. Among them, the first electrode 110' in the second electrode group II can be connected to the positive pole of the shock wave controller 30 through a wire 230. As described above, a current from the third end face 131' to the fourth end face 132' will be generated in the third electrode 130' belonging to the second electrode group II. Therefore, a voltage will exist between the third electrode 130' and the second electrode 120' belonging to the second electrode group II. As Figure 6B shown, the second electrode 120' in the second electrode group II can be connected to the first electrode 110 in the first electrode group I through a wire 230. Therefore, a voltage will also exist between the first electrode 110 and the third electrode 130 in the first electrode group I. A current from the third end face 131 to the fourth end face 132 will be generated in the third electrode 130 accordingly. Therefore, a voltage will exist between the third electrode 130 and the second electrode 120. The second electrode 120 belonging to the first electrode group I can be connected to the negative pole of the shock wave controller 30 through a wire 230. After the shock wave controller 30 is turned on, four shock waves will be generated at the two gaps 150' and the two gaps 150. The coverage angle of the four shock waves in the circumferential direction can be not less than 360°.

[0080] In order to enable the coverage range of the generated shock waves to cover the entire circumference, it can also be achieved by arranging a plurality of shock wave generating devices 10 at intervals in the axial direction (the illustrated X-X direction). In order to enable the coverage range of the shock waves to cover the entire circumference, at least three gaps 150 are required. For arranging a plurality of shock wave generating devices 10 at intervals in the axial direction, it can be arranging a shock wave generating device 10 with one gap 150 and a shock wave generating device 10 with two gaps 150 at intervals in the axial direction; it can also be arranging three shock wave generating devices 10 each with one gap 150 at intervals in the axial direction. In an embodiment of the present invention, a plurality of electrodes can form at least two electrode groups arranged at intervals along the axial direction of the inner tube 140. Each electrode group can include at least one electrode pair, and the electrodes corresponding to the electrode pair in each electrode group can be arranged in the circumferential direction. See Figure 7A and Figure 7B, at least two electrode groups may include a first electrode group I and a second electrode group II. The first electrode group I and the second electrode group II may be offset from each other in the circumferential direction Y-Y. For example, the second electrode group II may be rotated 90° relative to the first electrode group I in the circumferential direction Y-Y. The coverage ranges of the shock waves generated by the first electrode group I and the second electrode group II may complement each other. When the coverage ranges of the shock waves generated by the first electrode group I and the second electrode group II are superimposed, the coverage range of the overall generated shock wave can cover the entire circumference. Such a shock wave balloon catheter 20 has a simpler structure on the basis that the coverage range of the shock wave can cover the entire circumference.

[0081] It can be understood that the aforementioned covering of the entire circumference refers to the entire circumference of the same cross-section within the blood vessel. When the coverage ranges of the shock waves between multiple shock wave generating devices 10 spaced apart in the axial direction X-X complement each other, it can be achieved by the movement of the shock wave balloon catheter 20 in the axial direction X-X. Compared with arranging three shock wave generating devices 10 each having a gap 150 at intervals in the axial direction X-X, when arranging two shock wave generating devices 10 in the axial direction X-X and the coverage ranges of the shock waves generated by these two shock wave generating devices 10 are sufficient to cover the entire circumference, the shock wave balloon catheter 20 with two shock wave generating devices 10 can move a shorter distance in the axial direction X-X during use. And when the coverage range of the shock wave can cover the entire circumference by arranging two shock wave generating devices 10 in the axial direction X-X, at least one of these two shock wave generating devices 10 should include two or more gaps 150. For example, in an embodiment of the present invention, refer to Figure 8A , Figure 8B and Figure 8C, among two adjacent electrode groups, it may include the first electrode group I located at the proximal end of the inner tube 140 and the second electrode group II located at the distal end of the inner tube 140. The first electrode group I or / and the second electrode group II may include at least two electrode pairs. The gap 150 formed in the first electrode group I and the gap 150 formed in the second electrode group may be misaligned in the circumferential direction. The proximal end of the inner tube 140 is closer to the operator than the distal end of the inner tube 140. In such a shock wave balloon catheter 20, the first electrode group I and the second electrode group II may form two shock wave generating devices 10. The coverage range of the shock wave generated by the first electrode group I and the coverage range of the shock wave generated by the second electrode group II may complement each other. The first electrode group I and the second electrode group II may be regarded as a unit capable of generating shock waves covering the entire circumference. Since this unit only includes two electrode groups, its length in the axial direction X-X may be shorter. When the shock wave balloon catheter 20 moves in the blood vessel so that the coverage range of the shock wave can cover the entire circumference within the blood vessel wall, the moving distance may be shorter. For the shock wave balloon catheter 20, any number of such units may be provided.

[0082] Multiple electrodes may form multiple electrode groups. The projections of the gaps 150 respectively formed in two electrode groups adjacent to one of the electrode groups in a plane perpendicular to the axial direction may overlap. In an embodiment of the present invention, refer to Figure 9A and Figure 9B , taking the second electrode group II and the adjacent first electrode group I and third electrode group III in the shock wave balloon catheter 20 as an example. The projections of the gaps 150 respectively formed in the first electrode group I and the third electrode group III in a plane perpendicular to the axial direction may overlap. That is to say, the coverage ranges of the shock waves respectively generated in the first electrode group I and the third electrode group III are the same in the circumferential direction. The first electrode group I and the second electrode group II may be regarded as a unit capable of generating shock waves covering the entire circumference. At the same time, since the projection of the third electrode group III and the first electrode group I in a plane perpendicular to the axial direction may overlap, the second electrode group II and the third electrode group III may also be regarded as a unit capable of generating shock waves covering the entire circumference. When such a shock wave balloon catheter 20 moves in the blood vessel so that the coverage range of the shock wave can cover the entire circumference within the blood vessel wall, whether moving proximally or distally, the coverage range of the shock wave can cover the entire circumference within the blood vessel wall; and during the use of the shock wave balloon catheter 20, the proportion of the time when the cross-section to be treated within the blood vessel wall is covered by the shock wave over the entire circumference is greater.

[0083] Furthermore, two adjacent electrode groups may be the same, and there is a misalignment between two adjacent electrode groups in the circumferential direction Y-Y. Continue to refer to Figure 9A and Figure 9B, the first electrode group Ⅰ, the second electrode group Ⅱ, and the third electrode group Ⅲ can be the same electrode groups, except that there is a dislocation between every two adjacent electrode groups in the circumferential direction Y-Y. In this way, the electrode pair specifications used in the shock wave balloon catheter 20 are consistent, making production easier. Further, the dislocation angles between two adjacent electrode groups in the circumferential direction Y-Y can be the same, so that the arrangement of the insulating protrusions 141 on the inner tube 140 is more regular. Such a shock wave balloon catheter 20 can be more regular and easier to produce.

[0084] In an embodiment of the present invention, refer to Figure 7A , Figure 7B , Figure 8A , Figure 8B , Figure 8C , Figure 9A and Figure 9B。The electrode pair may include a first electrode 110 and a second electrode 120. In two adjacent electrode pairs, the first electrode 110 of one electrode pair may be connected to the second electrode 120 of the adjacent electrode pair at the distal end through a wire 230. The wire 230 may be attached to the tube body of the inner tube 140. Along the axial direction of the inner tube 140, the second electrode 120 of the electrode pair at the proximal end and the first electrode 110 of the electrode pair at the distal end are respectively used to be connected to the shock wave controller 30 through wires. The proximal end is closer to the operator than the distal end. When the second electrode 120 of the electrode pair at the proximal end is connected to the positive electrode of the shock wave controller 30, there is a voltage between the first electrode 110 and the second electrode 120 of the electrode pair at the proximal end. Since the first electrode 110 at the proximal end is connected to the second electrode 120 of the adjacent electrode pair at the distal end through the wire 230, there is also a voltage between the second electrode 120 of the adjacent electrode pair at the distal end and the first electrode 110 of the adjacent electrode pair at the distal end. In this way, the voltage can be transmitted to the electrode pair at the most distal end. The second electrode 120 of the electrode pair at the most distal end is connected to the first electrode 110 of the adjacent electrode pair at the proximal end through a wire, and the first electrode 110 of the electrode pair at the most distal end is connected to the positive electrode of the shock wave controller 30 through a wire. In this way, multiple electrode pairs can be all connected in series. Among them, the wire 230 can be attached to the tube body of the inner tube 140, which means that there is no stacking in the radial direction between the wire 230, the electrodes and the insulating protrusions. Therefore, the arrangement of the wire 230 will not increase the thickness in the radial direction. The electrodes and the insulating protrusions 141 can be reasonably arranged so that the wire 230 can be attached to the tube body of the inner tube 140. Since the multiple electrode pairs arranged in the axial direction X-X are sufficient to make the coverage range of the shock wave cover the entire circumference, it is not necessary for the electrodes and the insulating protrusions to cover the outer side surface of the inner tube 140 on any cross-section of the inner tube 140. Thus, there is always a gap on the outer side surface of the inner tube 140 where the wire 230 can be arranged. For such a shock wave balloon catheter 20, multiple electrode pairs are connected together in series, and the wire 230 can be attached to the tube body of the inner tube 140, so that the radial dimension of the overall device can still be relatively small, and the effect of applying it to interventional therapy is good.

[0085] In an embodiment of the present invention, the electrode pair may include a first electrode 110 and a second electrode 120. Each first electrode 110 and each second electrode 120 may be respectively connected to the shock wave controller 30 through wires. Multiple electrode pairs may be connected in parallel. In such a shock wave balloon catheter 20, each electrode pair is respectively connected to the shock wave controller 30. Even if any one of the multiple electrode pairs fails, it will not cause the entire shock wave balloon catheter 20 to be unable to work, and the stability of the overall device is better.

[0086] Of course, multiple electrode pairs in the shock wave balloon catheter 20 can also be partially connected in series and partially connected in parallel, which will not be elaborated here. Since the third electrode 130 actually only serves to transition between the first electrode 110 and the second electrode 120, the purpose of setting the third electrode 130 is to be able to adjust the actual position of the gap 150. Therefore, although the series connection between the multiple electrode pairs mentioned does not mention the third electrode 130, it can be understood that setting the third electrode 130 that is not connected to the shock wave controller 30 between the first electrode 110 and the second electrode 120 does not affect the overall connection form.

[0087] Shock waves always tend to be generated at the minimum distance between electrodes. In one embodiment of the present invention, referring to Figure 10A , Figure 10B , Figure 11A , Figure 11B and Figure 11C , the third electrode 130 can extend obliquely from the third end face 131 around the central axis of the inner tube 140 to the fourth end face 132. In such a shock wave balloon catheter 20, there is not only a distance between the first electrode 110 and the second electrode 120 in the circumferential direction Y-Y, but also a distance in the axial direction X-X, which can ensure that there is a sufficiently large distance between the first electrode 110 and the second electrode 120. The minimum distance between the first electrode 110 and other electrodes is only at the gap 150 between the first end face 111 and the third end face 131, and the minimum distance between the second electrode 120 and other electrodes is only at the gap 150 between the second end face 121 and the fourth end face 132. Furthermore, it can ensure that shock waves can be stably generated at the two gaps 150.

[0088] In an embodiment not shown, the third electrode 130 can extend spirally from the third end face 131 around the central axis of the inner tube 140 to the fourth end face 132. By cooperating the positions of the first electrode 110 and the second electrode 120 with such a third electrode 130, the gap 150 can be set at a more appropriate position, so that the applicable surface of the shock wave balloon catheter 20 can be wider.

[0089] In one embodiment of the present invention, referring to Figure 12A , Figure 12B , Figure 12C and Figure 12D, the insulating protrusions 141 can be at least two. At least two insulating protrusions 141 can form at least one pair of protrusions. The pair of protrusions can include two insulating protrusions 141. The two insulating protrusions 141 in the pair of protrusions can respectively include at least a part located between two electrodes in an electrode pair to space apart the two electrodes and form a gap 150. Both of the two insulating protrusions 141 space apart the two electrodes in an electrode pair to form the same gap 150, which can be understood as the two insulating protrusions 141 being located at both ends of this gap 150. By using a group of protrusions to space apart the two electrodes, the distance between the two electrodes is more stable and less likely to change. The size and position of the gap 150 can be more stable, so that the shock wave balloon catheter 20 can generate shock waves more stably and with higher efficiency.

[0090] Exemplarily, each electrode pair can correspond to at least one pair of protrusions. That is to say, the number of electrode pairs can be no greater than the number of pairs of protrusions. In this way, among all the gaps 150 on the shock wave balloon catheter 20, at least the gaps 150 with the same number as the number of electrode pairs have their sizes and positions determined by a pair of protrusions. These gaps 150 can generate shock waves more stably, so that the shock wave generating device 10 as a whole can generate shock waves more stably and with higher efficiency.

[0091] As introduced above, whether it is the arrangement of three electrodes such as the first electrode 110, the second electrode 120, and the third electrode 130 forming two gaps 150, or the arrangement of only two electrodes such as the first electrode 110 and the second electrode 120 forming one gap 150, the shock wave is generated only at the gap 150. Below, without considering the number of electrodes and electrode pairs, only the case where two electrodes in an electrode pair are spaced apart by a pair of protrusions to form a gap 150 will be introduced. Among the multiple electrodes that may be provided on the inner tube 140, the two electrodes in the electrode pair are the two electrodes participating in generating the shock wave. The two electrodes in the electrode pair can be arranged along the circumferential direction of the inner tube 140, and the insulating protrusions 141 can be parallel to the axial direction of the inner tube 140. As described above, when such a shock wave balloon catheter 20 moves on a curved and winding path, for example, when the shock wave balloon catheter 20 moves in a curved channel similar to a blood vessel, the two electrodes in the electrode pair are not likely to have relative displacement in the axial direction X-X, the relative positions of the two electrodes are not likely to change, and the size and position of the gap 150 are not likely to change. The shock wave balloon catheter 20 can generate shock waves more stably and is more suitable for interventional treatment.

[0092] In an embodiment of the present invention, refer to Figure 13A and Figure 13B, a protrusion pairs the two electrodes in the electrode pair to form a gap 150. An insulating protrusion 141' can still be provided in the gap 150, and the insulating protrusion 141' can split the gap 150. When the gap 150 has a relatively long length in the axial direction, the insulating protrusion 141' can split the gap 150 into two smaller gaps 150. When the shock wave generating device 10 generates a shock wave, serious ablation may occur on the opposite end faces of the two electrodes forming the gap 150. The insulating protrusion 141' splitting the gap 150 into two smaller gaps 150 can reduce the scope of ablation, thereby avoiding large-section ablation on the opposite end faces of the two electrodes. After the shock wave balloon catheter 20 is used for a period of time, the two electrodes can be slightly moved in the axial direction X-X, so that the unablated parts on the opposite end faces of the two electrodes form the gap 150, and thus the shock wave balloon catheter 20 can continue to be used to generate shock waves, thereby prolonging the service life of the overall device.

[0093] In an embodiment of the present invention, referring to Figure 14A and Figure 14B , the gap 150 may include a plurality of sub-gaps 151 arranged in the axial direction X-X, and at least two of the plurality of sub-gaps 151 may be misaligned in the circumferential direction. In this way, when a shock wave is generated in the gap 150, the ablation occurring on the opposite end faces of the two electrodes in the electrode pair can be in regions. Different regions on the opposite end faces corresponding to different sub-gaps 151 will have different ablation. In this way, the more severely ablated parts can be protected through reasonable design, thereby prolonging the service life of the shock wave balloon catheter 20.

[0094] Furthermore, referring to Figure 14A and Figure 14B , along the axial direction X-X, each sub-gap 151 is misaligned with the next sub-gap 151, and the misalignment direction of each sub-gap 151 with respect to the next sub-gap 151 is the same. The plurality of sub-gaps 151 can be arranged in a stepped shape along the axial direction X-X. In such a shock wave balloon catheter 20, the ablation occurring on the opposite end faces of the two electrodes in the electrode pair is not only in regions. Since the plurality of sub-gaps 151 are actually arranged in a stepped shape along the axial direction X-X, the ablation that occurs will also have a certain pattern, so that the end faces of the electrodes can be better protected in a targeted manner.

[0095] In an embodiment of the present invention, referring to Figure 15A and Figure 15B, the gap 150 may include a plurality of sub-gaps 151 arranged in the axial direction X-X. The plurality of sub-gaps 151 may respectively have a circumferential pitch in the circumferential direction. The plurality of circumferential pitches may also be arranged in the axial direction, and the plurality of circumferential pitches may decrease one by one in the axial direction. In the illustrated embodiment, the gap 150 includes two sub-gaps 151 arranged in the axial direction X-X. The two sub-gaps 151 respectively have a circumferential pitch M and a circumferential pitch N. Among them, the circumferential pitch M is greater than the circumferential pitch N. When such a shock wave generating device 10 generates a shock wave, a shock wave will preferentially be generated at the sub-gap 151 corresponding to the circumferential pitch N. Then, the end faces of the two electrodes at the sub-gap 151 corresponding to the circumferential pitch N will be ablated first. After the ablation occurs, the circumferential pitch N will continuously expand. When the circumferential pitch N expands to be close to the circumferential pitch M, a shock wave will also be generated at the sub-gap 151 corresponding to the circumferential pitch M. Such a shock wave generating device 10 will generate shock waves in a segmented manner, and the voltage requirements for generating shock waves are also different. Only when a shock wave is generated at the sub-gap 151 corresponding to the circumferential pitch N, since the circumferential pitch of the gap 150 where the shock wave is generated is small, the voltage required for the shock wave generating device 10 to generate a shock wave is small; when the circumferential pitch N expands to be close to the circumferential pitch M and a shock wave is also generated at the sub-gap 151 corresponding to the circumferential pitch M, since the circumferential pitch of the gap 150 where the shock wave is generated is large, the voltage required for the shock wave generating device 10 to generate a shock wave is large. At this time, an external shock wave controller 30 with adjustable voltage can be used to meet the requirements of the shock wave generating device 10. Moreover, since the circumferential pitch N is smaller than the circumferential pitch M, when only the sub-gap 151 corresponding to the circumferential pitch N generates a shock wave, the efficiency of the shock wave generating device 10 in generating a shock wave is higher. Such a shock wave generating device 10 that generates shock waves in a segmented manner will generate shock waves with an initially high efficiency, and the efficiency of generating shock waves will decrease after a period of time, which can meet the requirements of specific occasions, and the applicable surface of the shock wave balloon catheter 20 is wider.

[0096] At least one pair of electrodes may include a first electrode 110 and a second electrode 120. The first electrode 110 may have a first end face 111, and the second electrode 120 may have a second end face 121 opposite to the first end face 111. The first end face 111 and the second end face 121 may be spaced apart by at least one insulating protrusion 141 and a gap 150 may be formed therebetween. The first electrode 110 may be connected to the positive electrode of the external shock wave controller 30, so that the first electrode 110 may be regarded as the positive electrode. The second electrode 120 may be connected to the negative electrode of the external shock wave controller 30, so that the second electrode 120 may be regarded as the negative electrode. During long-term use, the first electrode 110 may always be used as the positive electrode, and the second electrode 120 may always be used as the negative electrode. In this way, the shock wave balloon catheter 20 may be more stable.

[0097] In one embodiment of the present invention, referring to Figure 16A and Figure 16B , a second protruding portion 1211 protruding toward the first end face 111 may be provided on the second end face 121, and at least a part of the gap 150 may be formed between the second protruding portion 1211 and the first end face 111. The second protruding portion 1211 may have a tip discharge effect. Therefore, providing the second protruding portion 1211 protruding toward the first end face 111 on the second end face 121 can make the discharge efficiency of the shock wave generating device 10 higher, and thus the efficiency of the shock wave balloon catheter 20 generating shock waves is also higher. Moreover, the first electrode 110 is connected to the positive electrode, and the second electrode 120 is connected to the negative electrode. When a breakdown phenomenon occurs at the gap 150, it can be considered that the breakdown occurs from the first end face 111 to the second end face 121. Compared with the ablation occurring on the first end face 111, more serious ablation may occur on the second end face 121. The setting of the second protruding portion 1211 can delay the damage of the second end face 121 due to ablation.

[0098] Similarly, in one embodiment of the present invention, referring to Figure 17A and Figure 17B , a first protruding portion 1111 protruding toward the second end face 121 may also be provided on the first end face 111, and at least a part of the gap 150 may be formed between the first protruding portion 1111 and the second end face 121. The first protruding portion 1111 may have a tip discharge effect. Therefore, providing the first protruding portion 1111 protruding toward the second end face 121 on the first end face 111 can make the discharge efficiency of the shock wave generating device 10 higher, and thus the efficiency of the shock wave balloon catheter 20 generating shock waves is also higher.

[0099] Particularly, referring to Figure 17A and Figure 17B , a first protruding portion 1111 protruding toward the second end face 121 may be provided on the first end face 111, and a second protruding portion 1211 protruding toward the first end face 111 may also be provided on the second end face 121. As described above, since there is a tip discharge effect at both the first protruding portion 1111 and the second protruding portion 1211, the efficiency of the shock wave balloon catheter 20 generating shock waves can be further improved.

[0100] ​In an embodiment of the present invention, the thickness of the insulating protrusion 141 in the radial direction may be equal to the thickness of the electrode pair in the radial direction. To ensure that the shock wave is generated in the gap 150, the thickness of the insulating protrusion 141 in the radial direction is generally not less than the thickness of the electrode pair in the radial direction. Otherwise, a shock wave may be generated between the portions of the two electrodes in the electrode pair that exceed the insulating protrusion 141 in the radial direction. On this basis, making the thickness of the insulating protrusion 141 in the radial direction equal to the thickness of the electrode pair in the radial direction can minimize the thickness of the shock wave generating device 10 in the radial direction. The shock wave balloon catheter 20 can have a smaller size in the radial direction and has a better effect when applied to interventional therapy.

[0101] The insulating protrusion 141 in the shock wave balloon catheter 20 may be integrally formed with the inner tube 140, or may be separately processed from the inner tube 140 and then connected by welding, clamping, gluing or various forms. Preferably, the insulating protrusion 141 can be formed by a tube extrusion one-piece forming process. The related tube extrusion process is mature and has high precision. Using the tube extrusion one-piece forming process to form the insulating protrusion 141 on the inner tube 140, when the electrodes are installed on the inner tube 140, there is no interference from connection parts such as welding feet between the insulating protrusion 141 and the inner tube 140, and there is no need to borrow additional calibration equipment to install the electrode pair. Therefore, it is easier to produce and has higher production efficiency.

[0102] Exemplarily, referring to Figure 18A , the gap 150 may be preset on the inner tube 140 before the electrode pair is installed on the inner tube 140. Among them, the gap 150 may be set on the insulating protrusion 141 by cutting, drilling or etching, etc., or may be naturally formed when the insulating protrusion 141 is formed on the inner tube 140 or may be naturally formed when the insulating protrusion 141 is connected to the inner tube 140.

[0103] In an embodiment of the present invention, referring to Figure 18B , a breakdown portion 1411 extending along the axial direction X-X of the inner tube 140 may be provided on the insulating protrusion 141, and the gap 150 may be formed on the breakdown portion 1411. The breakdown portion 1411 may be in the form of a window formed on the insulating protrusion 141, and the breakdown portion 1411 may have any shape. In such a shock wave balloon catheter 20, the contact area between the insulating protrusion 141 and the electrode can be larger, and the positioning effect on the electrode is better.

[0104] Exemplarily, the breakdown part 1411 can be made of a material with a low breakdown field strength. For example, the breakdown part 1411 can be filled with materials such as alumina. Such a breakdown part 1411 makes the breakdown phenomenon more likely to occur, and can reduce the voltage required for the shock wave generating device 10 in the shock wave balloon catheter 20 to generate shock waves.

[0105] In the description of the present invention, it should be understood that the orientation or positional relationship indicated by orientation words such as "front", "rear", "upper", "lower", "left", "right", "lateral", "vertical", "perpendicular", "horizontal" and "top", "bottom", etc. is usually based on the orientation or positional relationship shown in the drawings. It is only for the convenience of describing the present invention and simplifying the description. Without contrary description, these orientation words do not indicate and imply that the device or element referred to must have a specific orientation or be constructed and operated in a specific orientation. Therefore, it should not be construed as a limitation on the protection scope of the present invention; the orientation words "inside" and "outside" refer to the inside and outside relative to the contour of each component itself.

[0106] For the convenience of description, regional relative terms such as "above...", "over...", "on the upper surface of...", "above" etc. can be used here to describe the regional positional relationship between one or more components or features shown in the drawings and other components or features. It should be understood that the regional relative terms not only include the orientation of the components described in the drawings, but also different orientations during use or operation. For example, if the components in the drawings are inverted as a whole, then the component "above other components or features" or "over other components or features" will include the situation where the component is "below other components or structures" or "under other components or structures". Thus, the exemplary term "above..." can include both the orientations of "above..." and "below...". In addition, these components or features can also be positioned at other different angles (such as rotated 90 degrees or other angles), and this article intends to cover all such situations.

[0107] It should be noted that the terms used here are only for describing specific embodiments and are not intended to limit the exemplary embodiments according to the present invention. As used here, unless the context clearly indicates otherwise, the singular form is also intended to include the plural form. In addition, it should also be understood that when the terms "comprise" and / or "include" are used in this specification, they indicate the presence of features, steps, operations, components, assemblies and / or combinations thereof.

[0108] It should be noted that the terms "first", "second", etc. in the description, claims and above-mentioned drawings of the present invention are used to distinguish similar objects, and do not necessarily describe a specific order or sequence. It should be understood that the data used in this way can be interchanged under appropriate circumstances so that the embodiments of the present invention described here can be implemented in an order other than those illustrated or described here.

[0109] The present invention has been illustrated by the above embodiments. However, it should be understood that the above embodiments are only for the purpose of exemplification and illustration, and are not intended to limit the present invention to the scope of the described embodiments. In addition, those skilled in the art can understand that the present invention is not limited to the above embodiments, and more variations and modifications can be made according to the teachings of the present invention, and these variations and modifications all fall within the scope of protection of the present invention. The scope of protection of the present invention is defined by the appended claims and their equivalent scope.

Claims

1. A shock wave balloon catheter, characterized in that, The shock wave balloon catheter is used to be connected to a shock wave controller, and the shock wave balloon catheter includes: a balloon, with a chamber formed inside the balloon; an inner tube located in the chamber, and at least one insulating protrusion is provided on the tube body of the inner tube and protrudes outward in the radial direction of the inner tube; and at least two electrodes, at least two of the electrodes form at least one electrode pair, each electrode pair includes two of the electrodes respectively located on opposite sides of the insulating protrusion, at least two of the electrodes include a positive electrode and a negative electrode, and the positive electrode and the negative electrode are respectively used to be connected to the shock wave controller; wherein, the insulating protrusion and the electrodes are both located in the chamber, two of the electrodes in each electrode pair are spaced apart by the insulating protrusion and a gap for generating a shock wave is formed therebetween, the positive electrode and the negative electrode respectively receive trigger signals transmitted by the shock wave controller through corresponding wires, and a shock wave is generated in the gap under the trigger of the trigger signal.

2. The shock wave balloon catheter according to claim 1, wherein The wire is attached to the tube body of the inner tube.

3. The shock wave balloon catheter according to claim 1, characterized in that, The electrode pair includes a first electrode and a second electrode. Among adjacent two electrode pairs, the first electrode and the second electrode in the electrode pair adjacent to the distal end are connected by a wire; along the axial direction of the inner tube, the second electrode of the electrode pair located at the nearest end and the first electrode of the electrode pair located at the farthest end are respectively used to be connected to the shock wave controller through the wire; the proximal end is closer to the operator than the distal end.

4. The shock wave balloon catheter according to claim 1, wherein The electrode pair includes a first electrode and a second electrode, and each of the first electrode and the second electrode is respectively connected to the shock wave controller through the wire.

5. The shock wave balloon catheter according to claim 1, wherein There are multiple electrodes, and the multiple electrodes form at least three electrode pairs, the insulating protrusions are at least three, each electrode pair corresponds to at least one insulating protrusion, at least three insulating protrusions respectively space apart at least three electrode pairs to form at least three gaps, and the coverage angle of the shock waves generated in at least three gaps in the circumferential direction of the inner tube is not less than 360°.

6. The shock wave balloon catheter according to claim 5, characterized in that, Among at least three electrode pairs, three electrode pairs are arranged in the circumferential direction, the multiple electrodes corresponding to the three electrode pairs are arranged in the circumferential direction, and the three gaps formed by the three electrode pairs are at an angle of 120° with each other in the circumferential direction.

7. The shock wave balloon catheter according to claim 5, characterized in that, The multiple electrodes form at least two electrode groups arranged at intervals along the axial direction of the inner tube, each electrode group includes at least one electrode pair, and the electrodes corresponding to the electrode pairs in each electrode group are arranged in the circumferential direction.

8. The shock wave balloon catheter according to claim 7, wherein, Among two adjacent electrode groups, there is a first electrode group located at the proximal end of the inner tube and a second electrode group located at the distal end of the inner tube. The first electrode group or / and the second electrode group includes at least two electrode pairs. The gap formed in the first electrode group and the gap formed in the second electrode group are misaligned in the circumferential direction. The proximal end of the inner tube is closer to the operator than the distal end of the inner tube.

9. The shock wave balloon catheter according to claim 7, characterized in that, A plurality of the electrodes form a plurality of the electrode groups, and projections of the gaps respectively formed in two electrode groups adjacent to one of the electrode groups overlap in a plane perpendicular to the axial direction.

10. The shock wave balloon catheter according to claim 9, characterized in that, Two adjacent electrode groups are the same, and there is a dislocation between two adjacent electrode groups in the circumferential direction.

11. A shock wave system, characterized in that, It includes a shock wave controller and the shock wave balloon catheter according to any one of claims 1-10, and the shock wave balloon catheter is connected to the shock wave controller.

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