Shock wave generating device and shock wave balloon catheter

Abstract

The invention provides a shock wave generating device and a shock wave balloon catheter. The shock wave generating device comprises a tubular component and at least two electrodes, and at least one insulating protrusion is arranged on a tube body of the tubular component in the radial direction of the tubular component in an outward protruding mode. The at least two electrodes form at least one electrode pair, and each electrode pair comprises two electrodes which are respectively positioned on two opposite sides of the insulating bulge; wherein the two electrodes in each electrode pair are separated through an insulating protrusion, and a gap used for generating shock waves is formed between the two electrodes. The insulation protrusion can fix the size of the gap by positioning the two electrodes, so that the size of a shock wave generation area can be fixed, the generated shock wave is more stable, the shock wave stably occurs in the gap, the shock wave generation position can be controlled, and the generated shock wave is more stable. In addition, the two electrodes generating shock waves are not stacked and arranged in the radial direction, and the radial size of the whole device can be smaller.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular, to a shock wave generating device and a shock wave balloon catheter. 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 damaging the flexible tissues of the human body. Therefore, it has very good therapeutic effects on diseases such as stones and calcifications in the body, and thus has a very broad development prospect.

[0003] Generally, a shock wave generating device can be used to generate shock waves by utilizing the liquid-electric effect. The shock wave generating device usually has a catheter and an electrode pair. The electrode pairs in the existing shock wave generating devices are usually formed by stacking along the radial direction of the catheter or arranging along the axial direction of the catheter. Among them, for the shock wave generating device 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 when applied to interventional therapy; while for the shock wave generating device formed by arranging electrode pairs along the axial direction, the distance between the two electrodes will change with the movement path of the overall shock wave generating device. Especially when the shock wave generating device moves along a curved and winding path, the distance between the two electrodes will change significantly, thereby affecting the generation efficiency of the shock wave 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 generating device is provided. The shock wave generating device includes a tubular member and at least two electrodes. At least one insulating protrusion is provided on the tube body of the tubular member and protrudes outward along the radial direction of the tubular member; at least two electrodes form at least one electrode pair, and each electrode pair includes two electrodes located on opposite sides of the insulating protrusion respectively; wherein, 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.

[0005] The shock wave generating device provided by the present invention is provided with insulating protrusions on the tubular member, and the insulating protrusions can be used to position the electrode pair. The insulating protrusions separate the two electrodes in the electrode pair to form a gap. That is to say, both of the two electrodes can partially abut against the insulating protrusions. Therefore, the insulating protrusions can fix the size of the gap by positioning the two electrodes. Since the gap serves as the shock wave generating region, the size of the shock wave generating region can be fixed. No matter how the shock wave generating device moves or in what working environment, the insulating protrusions can stably position the two electrodes, so that the size of the gap remains unchanged. In this way, the generation of shock waves is more stable, and the efficiency of generating shock waves is higher. Moreover, since the shock waves are stably generated at the gap, the position where the shock waves are generated can be controlled, and the generation of shock waves is also more stable. In addition, the two electrodes in the electrode pair for generating shock waves are respectively located on both sides of the insulating protrusion. Therefore, the two electrodes for generating shock waves are not arranged in a radially stacked manner, but are respectively arranged on the tubular member, and the radial size of the overall device can be smaller, which is more suitable for application in interventional therapy.

[0006] Exemplarily, at least two electrodes include a first electrode, a second electrode, and a third electrode. The third electrode is located between the first electrode and the second electrode. The first electrode has a first end face, the second electrode has a second end face, the third electrode has a third end face close to the first end face and a fourth end face close to the second end face. The third end face and the first end face are separated by at least one insulating protrusion and a gap is formed therebetween; the fourth end face and the second end face are separated by at least one insulating protrusion and a gap is formed therebetween.

[0007] Exemplarily, the first electrode, the second electrode, and the third electrode are arranged along the circumferential direction of the tubular member, and the insulating protrusions are parallel to the axial direction of the tubular member.

[0008] Exemplarily, the third electrode extends obliquely from the third end face around the central axis of the tubular member to the fourth end face, or extends spirally from the third end face around the central axis of the tubular member to the fourth end face.

[0009] Exemplarily, there is one insulating protrusion among at least one insulating protrusion that separates the first end face and the third end face, and separates the second end face and the fourth end face.

[0010] Exemplarily, there are at least two insulating protrusions. The at least two insulating protrusions form at least one pair of protrusions. The pair of protrusions includes two insulating protrusions. The two insulating protrusions in the pair of protrusions respectively have at least a part located between the two electrodes in an electrode pair to separate the two electrodes to form a gap.

[0011] Exemplarily, each electrode pair corresponds to at least one pair of protrusions.

[0012] Exemplarily, two electrodes in the electrode pair are arranged along the circumferential direction of the tubular member, and the insulating protrusions are parallel to the axial direction of the tubular member.

[0013] Exemplarily, the gap includes a plurality of sub-gaps arranged in the axial direction, and at least two of the plurality of sub-gaps are misaligned in the circumferential direction.

[0014] Exemplarily, along the axial direction, each sub-gap is misaligned with respect to the next sub-gap, and the misalignment direction of each sub-gap with respect to the next sub-gap is the same.

[0015] Exemplarily, the gap includes a plurality of sub-gaps arranged in the axial direction, the plurality of sub-gaps respectively have circumferential pitches in the circumferential direction, the plurality of circumferential pitches are also arranged in the axial direction, and the plurality of circumferential pitches decrease one by one along the axial direction.

[0016] Exemplarily, at least one electrode pair includes a first electrode and a second electrode, the first electrode has a first end face, the second electrode has a second end face opposite to the first end face, the first end face and the second end face are spaced apart by at least one insulating protrusion and a gap is formed therebetween.

[0017] Exemplarily, a first protrusion protruding towards the second end face is provided on the first end face, and at least part of the gap is formed between the first protrusion and the second end face.

[0018] Exemplarily, a second protrusion protruding towards the first end face is provided on the second end face, and at least part of the gap is formed between the second protrusion and the first end face.

[0019] Exemplarily, the electrode pair includes a first electrode and a second electrode. In adjacent two electrode pairs, the first electrode is connected to the second electrode in the adjacent electrode pair at the distal end by a wire; along the axial direction of the tubular member, the second electrode of the electrode pair at the nearest end and the first electrode of the electrode pair at the farthest end are respectively used to connect to a shock wave controller; the proximal end is closer to the operator than the distal end.

[0020] Exemplarily, the electrode pair includes a first electrode and a second electrode, and each first electrode and each second electrode are respectively used to connect to a shock wave controller.

[0021] Exemplarily, the wire adheres to the tube body of the tubular member.

[0022] Exemplarily, there are a plurality of electrodes, the plurality of electrodes form at least three electrode pairs, there are at least three insulating protrusions, each electrode pair corresponds to at least one insulating protrusion, the at least three insulating protrusions respectively space apart the at least three electrode pairs to form at least three gaps, and the coverage angle of the shock waves generated in the at least three gaps in the circumferential direction of the tubular member is not less than 360°.

[0023] Exemplarily, among at least three electrode pairs, three electrode pairs are arranged in a circumferential direction, a plurality of electrodes corresponding to the three electrode pairs are arranged in the circumferential direction, and the three gaps respectively formed by the three electrode pairs have an included angle of 120° with each other in the circumferential direction.

[0024] Exemplarily, the plurality of electrodes form at least two electrode groups arranged at intervals in the axial direction of the tubular member, 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.

[0025] Exemplarily, among two adjacent electrode groups, there is a first electrode group located at the proximal end of the tubular member and a second electrode group located at the distal end of the tubular member. The first electrode group and / or the second electrode group includes at least two electrode pairs. The gap formed in the first electrode group is misaligned with the gap formed in the second electrode group in the circumferential direction. The proximal end of the tubular member is closer to the operator than the distal end of the tubular member.

[0026] Exemplarily, the plurality of electrodes form a plurality of 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.

[0027] Exemplarily, two adjacent electrode groups are the same and are misaligned in the circumferential direction.

[0028] Exemplarily, the tube body of the tubular member has an outer sidewall, an insulating protrusion is provided on the outer sidewall, and the electrode pair is provided on the outer sidewall.

[0029] Exemplarily, the tube body of the tubular member has a cavity, an outer sidewall and an inner sidewall. The cavity is formed between the inner surface of the outer sidewall and the outer surface of the inner sidewall. Among them, the insulating protrusion is connected between the inner surface and the outer surface. The electrode pair is provided in the cavity, and the gap is formed in the cavity.

[0030] Exemplarily, a hollowed-out part is provided on the outer sidewall, and at least a part of the hollowed-out part in the circumferential direction of the tubular member is located radially outside the gap.

[0031] Exemplarily, the cross-sectional shape of the tubular member is circular or polygonal.

[0032] Exemplarily, the insulating protrusion is formed by an integral forming process of tube extrusion.

[0033] Exemplarily, a breakdown part extending in the axial direction of the tubular member is provided on the insulating protrusion, and the gap is formed on the breakdown part.

[0034] Exemplarily, the breakdown part is made of a material with a low breakdown field strength.

[0035] According to another aspect of the present invention, a shock wave balloon catheter is provided. The shock wave balloon catheter includes a catheter and any one of the shock wave generating devices as described above, and a tubular member is formed on the catheter.

[0036] Exemplarily, the catheter includes at least two segments, and the tubular member is connected between at least two segments of the catheter.

[0037] A series of concepts in simplified form are introduced in the summary of the invention, which will be further described in detail in the detailed description 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.

[0038] The advantages and features of the present invention will be described in detail below with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] 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,

[0040] Figure 1 is a perspective view of a shock wave balloon catheter according to an exemplary embodiment of the present invention;

[0041] Figure 2A is a cross-sectional view (1) of a shock wave generating device according to an exemplary embodiment of the present invention;

[0042] Figure 2B is Figure 2A a cross-sectional view (2) of the shown shock wave generating device;

[0043] Figure 3A is a cross-sectional view (1) of a shock wave generating device according to an exemplary embodiment of the present invention;

[0044] Figure 3B is Figure 3A a cross-sectional view (2) of the shown shock wave generating device;

[0045] Figure 4A is a cross-sectional view (1) of a shock wave generating device according to an exemplary embodiment of the present invention;

[0046] Figure 4B is Figure 4A a cross-sectional view (2) of the shown shock wave generating device;

[0047] Figure 5A is a cross-sectional view (1) of a shock wave generating device according to an exemplary embodiment of the present invention;

[0048] Figure 5B isFigure 5A Cross-sectional view (II) of the shock wave generating device shown;

[0049] Figure 6A Front view of a shock wave generating device according to an exemplary embodiment of the present invention;

[0050] Figure 6B is Figure 6A Rear view of the shock wave generating device shown;

[0051] Figure 6C is Figure 6A Top view of the shock wave generating device shown;

[0052] Figure 7A Front view of a shock wave generating device according to an exemplary embodiment of the present invention;

[0053] Figure 7B is Figure 7A Rear view of the shock wave generating device shown;

[0054] Figure 7C is Figure 7A Top view of the shock wave generating device shown;

[0055] Figure 8A Isometric view of a tubular member according to an exemplary embodiment of the present invention;

[0056] Figure 8B Isometric view of a shock wave generating device according to an exemplary embodiment of the present invention from a front perspective;

[0057] Figure 8C is Figure 8B Isometric view of the shock wave generating device shown from a rear perspective;

[0058] Figure 8D is Figure 8B Isometric view of the shock wave generating device shown from a top perspective;

[0059] Figure 9A Cross-sectional view of a shock wave generating device according to an exemplary embodiment of the present invention;

[0060] Figure 9B is Figure 9A Top view of the shock wave generating device shown;

[0061] Figure 10A Cross-sectional view of a shock wave generating device according to an exemplary embodiment of the present invention;

[0062] Figure 10B is Figure 10A Top view of the shock wave generating device shown;

[0063] Figure 11A Cross-sectional view of a shock wave generating device according to an exemplary embodiment of the present invention;

[0064] Figure 11B is Figure 11A Top view of the shock wave generating device shown;

[0065] Figure 12A Cross-sectional view of a shock wave generating device according to an exemplary embodiment of the present invention;

[0066] Figure 12B is Figure 12A Top view of the shock wave generating device shown;

[0067] Figure 13A Cross-sectional view of a shock wave generating device according to an exemplary embodiment of the present invention;

[0068] Figure 13B is Figure 13A Top view of the shock wave generating device shown;

[0069] Figure 14A Partial top view of a shock wave generating device according to an exemplary embodiment of the present invention;

[0070] Figure 14B is Figure 14A Partial bottom view of the shock wave generating device shown;

[0071] Figure 14C is Figure 14A Cross-sectional view of the shock wave generating device shown under section P-P;

[0072] Figure 15A Partial front view of a shock wave generating device according to an exemplary embodiment of the present invention;

[0073] Figure 15B is Figure 15A Partial top view of the shock wave generating device shown;

[0074] Figure 16A Partial front view of a shock wave generating device according to an exemplary embodiment of the present invention;

[0075] Figure 16B is Figure 16A Partial rear view of the shock wave generating device shown;

[0076] Figure 16C is Figure 16A Partial top view of the shock wave generating device shown;

[0077] Figure 17APartial front view of a shock wave generating device according to an exemplary embodiment of the present invention;

[0078] Figure 17B is Figure 17A Partial rear view of the shock wave generating device shown;

[0079] Figure 18A Stereogram of a tubular member according to an exemplary embodiment of the present invention;

[0080] Figure 18B is Figure 18A Cross-sectional view of the tubular member shown;

[0081] Figure 19A Stereogram of a tubular member according to an exemplary embodiment of the present invention;

[0082] Figure 19B is Figure 19A Cross-sectional view of the tubular member shown;

[0083] Figure 20A Cross-sectional view of a tubular member according to an exemplary embodiment of the present invention;

[0084] Figure 20B Cross-sectional view of a tubular member according to an exemplary embodiment of the present invention;

[0085] Figure 21A Stereogram of a tubular member according to an exemplary embodiment of the present invention;

[0086] Figure 21B Stereogram of a tubular member according to an exemplary embodiment of the present invention;

[0087] Among them, the above-mentioned drawings include the following reference numerals:

[0088] 10, shock wave generating device; 110, first electrode; 111, first end face; 1111, first protruding portion; 120, second electrode; 121, second end face; 1211, second protruding portion; 130, third electrode; 131, third end face; 132, fourth end face; 140, tubular member; 141, 141', insulating protrusion; 1411, breakdown portion; 142, outer side wall; 1421, inner surface; 1422, hollowed-out portion; 143, cavity; 144, inner side wall; 1441, outer surface; 150, 150a, 150b, gap; 151, sub-gap; 20, shock wave balloon catheter; 210, catheter; 220, balloon; 230, wire. Detailed Description of the Invention

[0089] In the following description, numerous specific details are provided to enable a thorough understanding of the present invention. However, those skilled in the art will appreciate that the following description merely 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, to avoid confusion with the present invention, some technical features well known in the art are not described in detail.

[0090] According to one aspect of the present invention, a shock wave generating device is provided. The shock wave generating device can be applied to any suitable device, including but not limited to a shock wave balloon catheter. Therefore, according to another aspect of the present invention, referring to Figure 1 , a shock wave balloon catheter 20 is provided. The shock wave balloon catheter 20 may include a catheter 210, a balloon 220, and any one of the shock wave generating devices 10 to be introduced below.

[0091] Referring jointly to Figure 2A and Figure 2B , the shock wave generating device 10 may include a tubular member 140 and at least two electrodes. The at least two electrodes may include a first electrode 110 and a second electrode 120. Here, the first electrode 110 and the second electrode 120 are only for convenience of description and are not subject to any limitation. Generally, the shock wave balloon catheter 20 may further include a balloon surrounding the outer periphery of the shock wave generating device 10. The shock wave generating device 10 may be located inside the balloon by connecting to the catheter 210 through the tubular member 140. The tubular member 140 may be integrally formed and connected to the catheter 210. At this time, it can be considered that the tubular member 140 is formed on the catheter 210. For example, the tubular member 140 may be a relatively long pipe segment. In particular, in some embodiments, the tubular member 140 in the form of a relatively long pipe segment may replace the catheter 210; the tubular member 140 may also be sleeved on the catheter 210 and formed on the catheter 210. The tubular member 140 may also be separately processed from the catheter 210. The catheter 210 may include at least two segments. The tubular member 140 may be connected between at least two segments of the catheter 210 in various forms such as welding, clamping, or screw connection. For example, the tubular member 140 may be a relatively short pipe segment, and the tubular member 140 may be one or more. One or more tubular members 140 in the form of relatively short pipe segments may be connected between at least two segments of the catheter 210. Among them, two segments of the catheter 210 may be connected to both ends of one tubular member 140, or multiple tubular members 140 may be first connected together, and both ends of the whole are connected to two ends of the catheter 210. The tubular member 140 can be made of flexible materials such as polyamide, polyether block polyamide, polyimide, polytetrafluoroethylene, silica gel, or hard plastics such as polyurethane, polystyrene, polyethylene, and poly maleic anhydride ester. Among them, when the shock wave generating device is applied to the shock wave balloon catheter, the tubular member 140 is preferably made of a flexible material.

[0092] For ease of description, the tubular member 140 in the form of a cylinder will be taken as an example for illustration hereinafter. However, the specific form of the tubular member 140 is not limited in this application. The cross-section of the tubular member 140 can be of any form, which will be introduced in detail hereinafter. It is agreed that the axial direction of the tubular member 140 is the direction parallel to the central axis, the circumferential direction of the tubular member 140 (the Y-Y direction shown in the figure) is the direction of rotation around the center of the circle along the outer circumference on the cross-section of the tubular member 140, and the radial direction is the direction perpendicular to the circumferential direction Y-Y on the cross-section of the tubular member 140, that is, the direction extending along any diameter on the cross-section of the tubular member 140. The circumferential direction Y-Y and the radial direction of the tubular member 140 together can be understood as a polar coordinate system parallel to the paper surface, and the axial direction, the circumferential direction Y-Y and the radial direction of the tubular member 140 together can be understood as a cylindrical coordinate system perpendicular to the paper surface. At least one insulating protrusion 141 can be provided on the tube body of the tubular member 140 to protrude outward along the radial direction of the tubular member 140. The insulating protrusion 141 can be of any form. For example, the insulating protrusion 141 can have an arc-shaped cross-section, a cross-section similar to a square or various other forms.

[0093] Specifically refer to Figure 2A , 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 electrodes can be various forms of conductors. For example, the electrodes can be made of metal materials such as stainless steel, platinum-iridium alloy, nickel-titanium 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 by means of rolling, cutting and curling, etc., so as to enhance the flexibility of the shock wave generating device 10. The electrodes can be connected to an external shock wave controller. The shock wave controller can be a high-voltage pulse generating host, and the shock wave controller can have a positive electrode and a negative electrode. The electrodes can be respectively connected to the positive electrode or the negative electrode of the external shock wave controller. Among them, specifically refer to Figure 2B, 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 tubular member 140, or the electrodes can be connected to the tubular member 140 by gluing, welding or other various forms. When the electrodes are welded to the tubular member 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 both be greater than the length of the insulating protrusion 141 in the axial direction. In this way, the first electrode 110 and the second electrode 120 are spaced apart by the insulating protrusion 141 due to being located on both sides of the insulating protrusion 141 respectively. 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 of the gap 150 for generating a shock wave here 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. 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 to say, the gap 150 can undergo a breakdown phenomenon under the action of a strong voltage. The present application does not limit the correspondence between the electrode pair and the electrodes. For example, Figure 2A and Figure 2B The embodiments shown show an embodiment in which two electrodes form an electrode pair. Figure 3A and Figure 3B show an embodiment in which three electrodes form two electrode pairs through two 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.

[0094] The following will provide a detailed description of how the shock wave generating device 10 generates shock waves. For the two electrodes in an electrode pair, one can be connected to the positive pole of the shock wave controller, and the other can be connected to the negative pole of the shock wave controller. For example, the first electrode 110 can be connected to the positive pole of the shock wave controller, and the second electrode 120 can be connected to the negative pole of the shock wave controller. 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 can 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 and the second electrode 120 is connected to the negative pole of the shock wave controller, 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 is turned on, 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. Exemplarily, the shock wave generating device 10 can be placed in an environment of a conductive liquid. Placing the shock wave generating device 10 in an environment of a conductive liquid can be more conducive to the generation of shock waves. For example, when the shock wave generating device 10 is applied to the shock wave balloon catheter 20, the shock wave generating device 10 can be located inside the balloon, and the inside of the balloon can be filled with a conductive liquid. At this time, the breakdown phenomenon occurring at the gap 150 will trigger a liquid-electric effect in the conductive liquid, thereby generating shock waves. Of course, the shock wave generating device 10 provided in the present application is not limited to being applied to the shock wave balloon catheter 20. The shock wave generating device 10 can be applied to any suitable device, and can even be used to generate shock waves in vitro. When the shock wave generating device 10 is applied to other devices, an environment of a conductive liquid may not be necessary.

[0095] Such as Figure 2A and Figure 2BIn 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 tubular member 140 may extend in any direction. For example, the insulating protrusion 141 may extend obliquely around the central axis of the tubular member 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.

[0096] The shock wave generating device 10 provided by the present invention is provided with an insulating protrusion 141 on the tubular member 140, which can use the insulating protrusion 141 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, both of the two electrodes can partially abut against the insulating protrusion 141. 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 generating area, the size of the shock wave generating area can be fixed. No matter how the shock wave generating device 10 moves or in what working environment, the insulating protrusion 141 can stably position the two electrodes, so that the size of the gap 150 remains unchanged. In this way, the generation of shock waves is more stable, and the efficiency of generating shock waves is higher. Moreover, since the shock waves are stably generated at the gap 150, the position of the shock wave generation can be controlled, and the generation of shock waves is also more stable. In addition, the two electrodes in the electrode pair for generating shock waves are respectively located on both sides of the insulating protrusion 141. Therefore, the two electrodes for generating shock waves are not arranged in a radial stack, but are respectively arranged on the tubular member 140, and the radial dimension of the overall device can be smaller, which is more suitable for application in interventional therapy.

[0097] In an embodiment of the present invention, refer to Figure 3A and Figure 3B, 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 an external shock wave controller, the second electrode 120 may be connected to the negative electrode of the external shock wave controller, and the third electrode 130 may not be connected to the external shock wave controller. After the shock wave controller 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, and 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 generating device 10, the three electrodes can form two electrode pairs by using two insulating protrusions 141, and shock waves can be generated at both of the two gaps 150. In this way, the coverage range of the generated shock waves can be wider and the covered angle can 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 enables the shock waves generated by the shock wave generating device 10 to be more stable.

[0098] Generally, when a shock wave generating device moves in a curved channel, for example, when the shock wave generating device moves in a curved channel similar to a blood vessel, relative displacement in the axial direction is likely to occur between the electrode on the concave side of the bend and the electrode on the convex side of the bend, causing changes in the size and position of the gap for generating the shock wave, and thus changing the efficiency of generating the shock wave. In the shock wave generating device 10 provided by the present invention, although the size and position of the gap 150 are determined by the insulating protrusions 141, in order to further ensure that the size and position of the gap 150 are not easily changed, 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 tubular member 140, and the insulating protrusions 141 may be parallel to the axial direction of the tubular member 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 tubular member 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 tubular member 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, the relative positions of the first electrode 110, the second electrode 120, and the third electrode 130 are not likely to change, and the sizes and positions of the gap 150 formed between the first end face 111 and the third end face 131 and 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 generating device 10 can generate shock waves more stably and is more suitable for application in interventional therapy.

[0099] 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 may 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 one electrode group, the tubular member 140 may include two electrode groups, and 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, it is possible to achieve a coverage angle of the generated shock wave of not less than 360°.

[0100] In an embodiment of the present invention, refer to Figure 5A and Figure 5B, two first electrodes 110, two second electrodes 120, and one third electrode 130 are provided on the tubular member 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, and the electrode group includes two electrode pairs, which can generate shock waves at two gaps 150 separated by two insulating protrusions 141; the remaining one first electrode 110 and one second electrode 120 can form an electrode pair, which can generate shock waves at the gap 150 separated 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. Thus, through reasonable arrangement, the coverage range of the generated shock waves can have an angle of not less than 360° in the circumferential direction Y-Y. For example, the three insulating protrusions 141 can be arranged at intervals of 120° from each other in the circumferential direction Y-Y. Such a shock wave generating device 10 realizes a coverage range angle of the shock waves of not less than 360° with a simpler structure.

[0101] For the shock wave generating device 10 with a coverage range angle of the generated shock waves of not less than 360°, the efficiency of the generated shock waves in affecting the outside is higher. For example, when applied to interventional therapy, such a shock wave generating device 10 can affect the entire circumference of the inner wall of the blood vessel, and the treatment effect is better.

[0102] Shock waves always tend to be generated at the minimum distance between electrodes. In an embodiment of the present invention, refer to Figure 6A , Figure 6B and Figure 6C , the third electrode 130 can extend obliquely from the third end face 131 to the fourth end face 132 around the central axis of the tubular member 140. In such a shock wave generating device 10, 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 (the illustrated X-X direction), 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.

[0103] In an embodiment of the present invention, refer to Figure 7A , Figure 7B and Figure 7C, the third electrode 130 can helically extend from the third end face 131 to the fourth end face 132 around the central axis of the tubular member 140. 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 generating device 10 can be wider. Further, there can be an insulating protrusion 141 among the at least one insulating protrusion 141 that separates the first end face 111 from the third end face 131 and separates the second end face 121 from the fourth end face 132. In such a shock wave generating device 10, only one insulating protrusion 141 can be provided on the tubular member 140, and the overall structure can be simpler. To improve the structural stability of the shock wave generating device 10, two insulating protrusions 141' can also be provided. The two insulating protrusions 141' can be respectively located at both ends of the insulating protrusion 141 in the axial direction X-X, and one of the two insulating protrusions 141' can be located between the first end face 111 and the third end face 131 to separate the first electrode 110 from the third electrode 130 and further position the gap 150a, and the other can be located between the second end face 121 and the fourth end face 132 to separate the second electrode 120 from the third electrode 130 and further position the gap 150b. The structure of such a shock wave generating device 10 can be more stable, and the three insulating protrusions 141 are located on a straight line parallel to the axial direction X-X, which is also easier to manufacture.

[0104] In an embodiment of the present invention, referring to Figure 8A , Figure 8B , Figure 8C and Figure 8D , the insulating protrusion 141 can be at least two. The 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 have at least a part located between the two electrodes in an electrode pair, so as to separate the two electrodes to form a gap 150. Both of the two insulating protrusions 141 separate 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 separating the two electrodes with a group of protrusions, the distance between the two electrodes is more stable and the distance is not likely to change. The size and position of the gap 150 can be more stable, so that the shock wave generating device 10 can generate shock waves more stably and the efficiency of generating shock waves can be higher.

[0105] Exemplarily, each pair of electrodes may correspond to at least one pair of protrusions. That is to say, the number of pairs of electrodes may not be greater than the number of pairs of protrusions. Among all the gaps 150 on such a shock wave generating device 10, at least the gaps 150 with the same number as the number of pairs of electrodes 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.

[0106] 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 pairs of electrodes, only the case where two electrodes in a pair of electrodes 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 tubular member 140, the two electrodes in the pair of electrodes are the two electrodes participating in generating the shock wave. The two electrodes in the pair of electrodes can be arranged along the circumferential direction of the tubular member 140, and the insulating protrusion 141 can be parallel to the axial direction of the tubular member 140. As described above, 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 X-X between the two electrodes in the pair of electrodes is not likely to occur, the relative positions of the two electrodes are not likely to change, the sizes and positions of the gaps 150 are not likely to change, and the shock wave generating device 10 can generate shock waves more stably and is more suitable for application in interventional therapy.

[0107] In an embodiment of the present invention, referring to Figure 9A and Figure 9B , a pair of protrusions spaces apart the two electrodes in the pair of electrodes to form a gap 150. An insulating protrusion 141' may 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 between the two electrodes forming the gap 150. The insulating protrusion 141' splitting the gap 150 into two smaller gaps 150 can reduce the range of ablation, thereby avoiding large-section ablation on the opposite end faces between the two electrodes. After the shock wave generating device 10 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 generating device 10 can continue to be used to generate shock waves, thereby extending the service life of the overall device.

[0108] In one embodiment of the present invention, referring to Figure 10A and Figure 10B , 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. When a shock wave is generated in the gap 150 in this way, the ablation occurring on the opposite end faces of the two electrodes in the electrode pair can be in sub-regions, and different regions on the opposite end faces corresponding to different sub-gaps 151 will undergo different ablation. In this way, through reasonable design, the more severely ablated parts can be protected, thereby extending the service life of the shock wave generating device 10.

[0109] Furthermore, referring to Figure 10A and Figure 10B , along the axial direction X-X, each sub-gap 151 is misaligned relative to the next sub-gap 151, and the misalignment direction of each sub-gap 151 relative to the next sub-gap 151 is the same. The plurality of sub-gaps 151 may be arranged in a stepped manner along the axial direction X-X. In such a shock wave generating device 10, the ablation occurring on the opposite end faces of the two electrodes in the electrode pair is not only in sub-regions, but also has a certain pattern because the plurality of sub-gaps 151 are actually arranged in a stepped manner along the axial direction X-X, so that the end faces of the electrodes can be better protected in a targeted manner.

[0110] In one embodiment of the present invention, referring to Figure 11A and Figure 11B, 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 be preferentially 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 generates 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 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 shock waves is higher. Such a shock - wave generating device 10 that generates shock waves in a segmented manner will generate shock waves with an initially higher 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 range of the shock - wave generating device 10 is wider.

[0111] 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 pole of an external shock - wave controller, so that the first electrode 110 can be regarded as a positive electrode. The second electrode 120 may be connected to the negative pole of the external shock - wave controller, so that the second electrode 120 can be regarded as a negative electrode. During long - term use, the first electrode 110 can always be used as the positive electrode, and the second electrode 120 can always be used as the negative electrode. In this way, the shock - wave generating device 10 can be more stable.

[0112] In one embodiment of the present invention, referring to Figure 12A and Figure 12B , 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 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 breakdown occurs at the gap 150, it can be considered that 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.

[0113] Similarly, in one embodiment of the present invention, referring to Figure 13A and Figure 13B , 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 generating shock waves is also higher.

[0114] Specifically, referring to Figure 13A and Figure 13B , 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 tip discharge effects exist at both the first protruding portion 1111 and the second protruding portion 1211, the efficiency of generating shock waves in the shock wave generating device 10 can be further improved.

[0115] In one embodiment of the present invention, referring to Figure 14A , Figure 14B , Figure 14C , Figure 15A , Figure 15B , Figure 16A , Figure 16B , Figure 16C , Figure 17A and Figure 17B。The electrode pair may include a first electrode 110 and a second electrode 120. In two adjacent electrode pairs, the first electrode 110 may be connected to the second electrode 120 in the adjacent distal electrode pair through a wire 230. The wire 230 may be attached to the tube body of the tubular member 140. Along the axial direction of the tubular member 140, the second electrode 120 of the electrode pair at the nearest end and the first electrode 110 of the electrode pair at the farthest end are respectively used to be connected to the shock wave controller through the wire 230. The proximal end is closer to the operator than the distal end. When the second electrode 120 of the electrode pair at the nearest end is connected to the positive electrode of the shock wave controller, there is a voltage between the first electrode 110 and the second electrode 120 of the electrode pair at the nearest end. And since the first electrode 110 at the nearest end is connected to the second electrode 120 in the adjacent distal electrode pair through the wire 230, there is also a voltage between the second electrode 120 and the first electrode 110 in the adjacent distal electrode pair. In this way, the voltage can be transmitted to the electrode pair at the farthest end. The second electrode 120 in the electrode pair at the farthest end is connected to the first electrode 110 in the adjacent proximal electrode pair through a wire, and the first electrode 110 in the electrode pair at the farthest end is connected to the positive electrode of the shock wave controller through the wire 230. 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 tubular member 140, which means that there is no stacking in the radial direction between the wire 230, the electrodes and the insulating protrusions. Thus, 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 tubular member 140. Since the multiple electrode pairs arranged in the axial direction X-X are sufficient to enable the coverage range of the shock wave to cover the entire circumference, it is not necessary for the electrodes and the insulating protrusions to cover the outer side surface of the tubular member on any cross-section of the tubular member 140. In this way, there are always gaps on the outer side surface of the tubular member 140 where the wire 230 can be arranged. For such a shock wave generating device 10, multiple electrode pairs are connected together in series, and the wire 230 can be attached to the tube body of the tubular member 140, so that the radial dimension of the overall device can still be relatively small, and the effect in interventional therapy is good. Moreover, multiple electrode pairs are connected together in series. When the number of electrodes is relatively large, the number of wires 230 is still small, and the overall wiring of the wires 230 can be simpler.

[0116] 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 through a wire 230. Multiple electrode pairs may be connected in parallel. In such a shock wave generating device 10, each electrode pair is respectively connected to the shock wave controller. Even if any one of the multiple electrode pairs fails, it will not cause the entire shock wave generating device 10 to stop working, and the stability of the overall device is better.

[0117] Of course, some of the multiple electrode pairs in the shock wave generating device 10 can be connected in series, and some can be connected in parallel, which will not be elaborated here. When the shock wave generating device 10 includes any one of the third electrodes 130 as described above, since the third electrode 130 actually only serves as a 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 between the first electrode 110 and the second electrode 120 does not affect the overall connection form.

[0118] In an embodiment of the present invention, the wire can be attached to the tube body of the tubular member 140. That is to say, on any cross-section of the shock wave generating device 10, there is always a gap on the outer peripheral side of the tubular member 140 where the wire can be arranged. For example, on the outer peripheral side of the tubular member 140, the electrodes and the insulating protrusions 141 do not cover the entire outer peripheral side of the tubular member 140. In this way, the wires, electrodes, and insulating protrusions in the shock wave generating device 10 will not be stacked in the radial direction, and the overall thickness in the radial direction can be smaller, making it easier to move in small blood vessels, and thus more suitable for use in interventional therapy, and the therapeutic effect of interventional therapy is also better.

[0119] In an embodiment of the present invention, refer to Figure 5A and Figure 5B , there can be multiple electrodes, 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, and at least three insulating protrusions 141 can separate at least three electrode pairs to form at least three gaps 150. The coverage angle of the shock waves generated in at least three gaps 150 in the circumferential direction of the tubular member 140 can be not less than 360°. That is to say, through reasonable arrangement of at least three gaps 150, the shock waves generated therein can cover the entire circumference in the circumferential direction. When the shock wave generating device 10 is applied to interventional therapy, the generated shock waves cover the entire circumference, and the calcified plaques on the entire circumference within the blood vessel wall can be treated simultaneously, without the need to adjust the angle multiple times and repeat the treatment multiple times, so the treatment efficiency is naturally higher.

[0120] In an embodiment of the present invention, refer to Figure 5A and Figure 5B, among 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 three gaps 150 formed corresponding to the three electrode pairs can have an angle of 120° with each other in the circumferential direction. For one shock wave generating device 10 in the shock wave generating device 10, two first electrodes 110, two second electrodes 120, and one third electrode 130 are provided on the tubular member 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, and the electrode group includes two electrode pairs, and shock waves can be generated at the two gaps 150 separated 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 shock waves can be generated at the gap 150 separated 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° from each other in the circumferential direction Y-Y. Such a shock wave generating device 10 realizes a coverage range angle of the shock wave not less than 360° with a simpler structure.

[0121] On the shock wave generating device 10, it is possible to 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 14A , Figure 14B and Figure 14C . As shown in the figure, one shock wave generating device 10 on the shock wave generating device 10 is shown. Since the coverage range of the shock waves generated by this shock wave generating device 10 has an angle not less than 360° in the circumferential direction, even if only such one shock wave generating device 10 is provided in the shock wave generating device 10, a good treatment effect can be achieved, and the overall structure can be very simple. Taking one first electrode 110, one second electrode 120, and one third electrode 130 as an electrode group, the illustrated embodiment includes two electrode groups, which are respectively Figure 14C the first electrode group Ⅰ located in the upper left corner in Figure 14C and the second electrode group Ⅱ located in the lower right corner in Figure 14BAs 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. As a result, there will also be a voltage between the first electrode 110 and the third electrode 130 in the first electrode group I. Consequently, a current will be generated in the third electrode 130 from the third end face 131 to the fourth end face 132, and thus 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 electrode of the shock wave controller through the wire 230. After the shock wave controller is turned on, four shock waves will be generated at the two gaps 150' and the two gaps 150. The coverage range of the four shock waves in the circumferential direction can be not less than 360°.

[0122] 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 X-X direction shown in the figure). 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 that a shock wave generating device 10 with one gap 150 and a shock wave generating device 10 with two gaps 150 are arranged at intervals in the axial direction; it can also be that three shock wave generating devices 10 each having one gap 150 are arranged 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 in the axial direction of the tubular member 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. Refer to Figure 15A and Figure 15B , at least two electrode groups can include the first electrode group I and the second electrode group II. The first electrode group I and the second electrode group II can be misaligned with each other in the circumferential direction Y-Y. For example, the second electrode group II can be rotated by 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 can complement each other. The coverage ranges of the shock waves generated by the first electrode group I and the second electrode group II are superimposed, so that the coverage range of the overall generated shock waves can cover the entire circumference. Such a shock wave generating device 10 has a simpler structure on the basis that the coverage range of the shock waves can cover the entire circumference.

[0123] It is understandable that the aforementioned coverage of the entire circumference refers to the entire circumference on the same cross section in the blood vessel. When a plurality of shock wave generating devices 10 spaced apart in the axial direction XX complement each other in terms of the coverage of the shock wave, this can be achieved by moving the shock wave generating device 10 in the axial direction XX. Compared to setting three shock wave generating devices 10 spaced apart in the axial direction XX, each having a gap 150, setting two shock wave generating devices 10 spaced apart in the axial direction XX, and when the coverage of the shock wave generated by these two shock wave generating devices 10 is sufficient to cover the entire circumference, the shock wave generating device 10 with two shock wave generating devices 10 can move a shorter distance in the axial direction XX during use. When two shock wave generating devices 10 are provided in the axial direction XX so that the coverage of the shock wave can cover the entire circumference, at least one of the two shock wave generating devices 10 should include two or more gaps 150. For example, in one embodiment of the present invention, see Figure 16A , Figure 16B and Figure 16C , the two adjacent electrode groups may include a first electrode group I located at the proximal end of the tubular member 140 and a second electrode group II located at the distal end of the tubular member 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, and the proximal end of the tubular member 140 is closer to the operator than the distal end of the tubular member 140. In such a shock wave generating device 10, 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, and since this unit only includes two electrode groups, the length in the axial direction XX may be shorter, and when the shock wave generating device 10 moves in the blood vessel so that the coverage range of the shock wave can cover the entire circumference in the blood vessel wall, the moving distance may be shorter. For the shock wave generating device 10 , any number of such units may be provided.

[0124] The plurality of electrodes may form a plurality of electrode groups, and the projections of the gaps 150 respectively formed in two electrode groups adjacent to one electrode group on a plane perpendicular to the axial direction may overlap. Figure 17A and Figure 17B, taking the second electrode group II and the adjacent first electrode group I and third electrode group III in the shock wave generating device 10 as examples. The projections of the gaps 150 respectively formed in the first electrode group I and the third electrode group III on a plane perpendicular to the axial direction can 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 can be regarded as a unit capable of generating a shock wave covering the entire circumference. At the same time, since the projection of the third electrode group III and the first electrode group I on a plane perpendicular to the axial direction can overlap, the second electrode group II and the third electrode group III can also be regarded as a unit capable of generating a shock wave covering the entire circumference. When such a shock wave generating device 10 moves in a 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; moreover, during the use of the shock wave generating device 10, the proportion of the time when the cross-section to be treated within the blood vessel wall is covered by the shock wave covering the entire circumference is larger.

[0125] Further, two adjacent electrode groups can be the same, and there is a dislocation between two adjacent electrode groups in the circumferential direction Y-Y. Continuing to refer to Figure 17A and Figure 17B , 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. The electrode pair specifications used in such a shock wave generating device 10 are consistent, and production is 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 tubular member 140 is more regular. Such a shock wave generating device 10 can be more regular and easier to produce.

[0126] In an embodiment of the present invention, the tube body of the tubular member 140 can have an outer wall, the insulating protrusions 141 can be arranged on the outer wall, and the electrode pairs can be arranged on the outer wall. When the shock wave generating device 10 is applied to interventional therapy, for example, when the shock wave generating device 10 is applied to the shock wave balloon catheter 20, interventional therapy has strict requirements on the inner diameter and the thickness in the radial direction of the tubular member 140. The tubular member 140 only serves to carry the insulating protrusions 141 and the electrodes. Therefore, the insulating protrusions 141 and the electrodes can be arranged on the outer wall of the tube body of the tubular member 140 to minimize the size of the shock wave generating device 10 in the radial direction. A smaller-sized shock wave generating device 10 can be more suitable for interventional therapy.

[0127] In an embodiment of the present invention, referring to Figure 18A and Figure 18B, the tube body of the tubular member 140 may have a cavity 143, an outer sidewall 142, and an inner sidewall 144. The outer sidewall 142 and the inner sidewall 144 may both have a thickness in a certain radial direction. The cavity 143 may be formed between the inner surface 1421 of the outer sidewall 142 and the outer surface 1441 of the inner sidewall 144. Among them, the insulating protrusion 141 may be connected between the inner surface 1421 and the outer surface 1441. The electrode pair may be disposed in the cavity 143, and a gap (not shown) may be formed in the cavity 143. Such a shock wave generating device 10 is equivalent to being sleeved with a tubular fixing member, and the tubular fixing member is integrally formed with the tubular member 140. The structure of such a shock wave generating device 10 can be more stable.

[0128] In the shock wave generating device 10 where a gap is formed in the cavity 143, the outer sidewall 142 may block the shock wave. Exemplarily, a hollowed-out portion 1422 may be provided on the outer sidewall 142. At least a part of the hollowed-out portion 1422 in the circumferential direction of the tubular member 140 may be located radially outside the gap (not shown). The hollowed-out portion 1422 will not block the shock wave generated in the gap, so that the effect of the shock wave generating device 10 generating the shock wave can be better.

[0129] In an embodiment of the present invention, refer to Figure 19A and Figure 19B , when the tube body of the tubular member 140 has a cavity 143, an outer sidewall 142, and an inner sidewall 144, the electrode pair may be disposed in the cavity 143. Among them, the electrode pair may also include three electrodes, namely a first electrode 110, a second electrode 120, and a third electrode 130, to form two electrode pairs. Similar to the above content, it will not be elaborated here.

[0130] 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 usually not less than the thickness of the electrode pair in the radial direction. Otherwise, a shock wave may be generated between the parts of the two electrodes in the electrode pair that exceed the insulating protrusion 141 in the radial direction. On this basis, the thickness of the insulating protrusion 141 in the radial direction being 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, making it more suitable for interventional therapy, having a wider application range, and better effect when applied to interventional therapy.

[0131] In the previous introduction, for the convenience of description, the cross-section of the tubular member 140 is taken as a circle as an example. In fact, the cross-section of the tubular member 140 may be in various forms such as a circle or a polygon. In an embodiment of the present invention, refer to Figure 20A, the cross-sectional shape of the tubular member 140 can be polygonal. In another embodiment of the present invention, refer to Figure 20B , the cross-sectional shape of the tubular member 140 can also be polygonal. The polygonal tubular member 140 can be more easily transported and stored.

[0132] The insulating protrusion 141 in the shock wave generating device 10 can be integrally formed with the tubular member 140, or can be separately processed from the tubular member 140 and then connected by welding, snap connection, gluing or various forms. Preferably, the insulating protrusion 141 can be formed by an extrusion molding process of a pipe. The related pipe extrusion process is mature and has high precision. Using the extrusion molding process of a pipe to form the insulating protrusion 141 on the tubular member 140, when the pair of electrodes is installed on the tubular member 140, there is no interference from joints such as weld beads between the insulating protrusion 141 and the tubular member 140, and there is no need to borrow additional calibration equipment to install the pair of electrodes, so it is easier to produce and has higher production efficiency.

[0133] Exemplarily, refer to Figure 21A , the gap 150 can be preset on the tubular member 140 before the pair of electrodes is installed on the tubular member 140. Among them, the gap 150 can be set on the insulating protrusion 141 by cutting, drilling or etching, etc., or can be naturally formed when the insulating protrusion 141 is formed on the tubular member 140 or the insulating protrusion 141 is connected to the tubular member 140.

[0134] In one embodiment of the present invention, refer to Figure 21B , a breakdown portion 1411 extending along the axial direction X-X of the tubular member 140 can be provided on the insulating protrusion 141, and the gap 150 can be formed on the breakdown portion 1411. The breakdown portion 1411 can be in the form of a window formed on the insulating protrusion 141, and the breakdown portion 1411 can have any shape. In such a shock wave generating device 10, the contact area between the insulating protrusion 141 and the electrode can be larger, and the positioning effect on the electrode is better.

[0135] Exemplarily, the breakdown portion 1411 can be made of a material with a low breakdown field strength. For example, the breakdown portion 1411 can be filled with materials such as alumina. Such a breakdown portion 1411 makes the breakdown phenomenon more likely to occur and can reduce the voltage required for the shock wave generating device 10 to generate a shock wave.

[0136] In the description of the present invention, it should be understood that the orientation or positional relationship indicated by orientation terms such as "front", "rear", "upper", "lower", "left", "right", "lateral", "vertical", "perpendicular", "horizontal", "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 explanation, these orientation terms 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 terms "inside" and "outside" refer to the inside and outside relative to the contour of each component itself.

[0137] For convenience of description, regional relative terms such as "above...", "over...", "on the upper surface of...", "upper...", 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 document is intended to cover all such situations.

[0138] 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.

[0139] 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 need to describe a specific order or sequence. It should be understood that such used data 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.

[0140] The present invention has been described by the above embodiments. However, it should be understood that the above embodiments are only for illustrative and exemplary purposes, 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 required by 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 generating device, characterized in that, Comprising: A tubular member, on the tube body of the tubular member, at least one insulating protrusion is provided protruding outward in the radial direction of the tubular member; And At least two electrodes, at least two of the electrodes form at least one electrode pair, and each electrode pair includes two of the electrodes respectively located on opposite sides of the insulating protrusion; Wherein, the two electrodes in each electrode pair are spaced apart by the insulating protrusion and a gap for generating shock waves is formed therebetween.

2. The shock wave generating device according to claim 1, characterized in that, At least two of the electrodes include a first electrode, a second electrode and a third electrode, the third electrode is located between the first electrode and the second electrode, the first electrode has a first end face, the second electrode has a second end face, the third electrode has a third end face close to the first end face and a fourth end face close to the second end face, the third end face and the first end face are spaced apart by at least one of the insulating protrusions and the gap is formed therebetween; the fourth end face and the second end face are spaced apart by at least one of the insulating protrusions and the gap is formed therebetween.

3. The shock wave generating device according to claim 2, characterized in that, The first electrode, the second electrode and the third electrode are arranged in the circumferential direction of the tubular member, and the insulating protrusion is parallel to the axial direction of the tubular member.

4. The shock wave generating device according to claim 2, characterized in that, The third electrode extends obliquely from the third end face around the central axis of the tubular member to the fourth end face, or extends spirally from the third end face around the central axis of the tubular member to the fourth end face.

5. The shock wave generating device according to claim 4, characterized in that, There is one of the at least one insulating protrusion that spaces apart the first end face and the third end face, and spaces apart the second end face and the fourth end face.

6. The shock wave generating device according to claim 1, wherein, The insulating protrusions are at least two, and at least two of the insulating protrusions form at least one protrusion pair, the protrusion pair includes two of the insulating protrusions, and two of the insulating protrusions in the protrusion pair respectively have at least a part located between two of the electrodes in one electrode pair to space apart the two electrodes to form the gap.

7. The shock wave generating device according to claim 6, characterized in that, Each electrode pair corresponds to at least one protrusion pair.

8. The shock wave generating device according to claim 1, wherein, The two electrodes in the electrode pair are arranged in the circumferential direction of the tubular member, and the insulating protrusion is parallel to the axial direction of the tubular member.

9. The shock wave generating device according to claim 8, wherein, The gap includes a plurality of sub-gaps arranged in the axial direction, and at least two of the plurality of sub-gaps are misaligned in the circumferential direction.

10. The shock wave generating device according to claim 9, characterized in that, Along the axial direction, each sub-gap is misaligned with the next sub-gap, and the misalignment direction of each sub-gap with respect to the next sub-gap is the same.

11. The shock wave generating device according to claim 8, characterized in that, The gap includes a plurality of sub-gaps arranged in the axial direction, the plurality of sub-gaps respectively have circumferential spacings in the circumferential direction, the plurality of circumferential spacings are also arranged in the axial direction, and the plurality of circumferential spacings decrease one by one along the axial direction.

12. The shock wave generating device according to claim 1, wherein At least one of the electrode pairs includes a first electrode and a second electrode. The first electrode has a first end face, and the second electrode has a second end face opposite to the first end face. The first end face and the second end face are spaced apart by at least one of the insulating protrusions, and a gap is formed therebetween.

13. The shock wave generating device according to claim 12, wherein, A first protrusion protruding toward the second end face is provided on the first end face, and at least a part of the gap is formed between the first protrusion and the second end face; and / or, a second protrusion protruding toward the first end face is provided on the second end face, and at least a part of the gap is formed between the second protrusion and the first end face.

14. The shock wave generating device according to claim 1, characterized in that, The electrode pair includes a first electrode and a second electrode. In two adjacent electrode pairs, the first electrode and the second electrode in the adjacent electrode pair at the distal end are connected by a wire; along the axial direction of the tubular member, the second electrode of the electrode pair at the nearest end and the first electrode of the electrode pair at the farthest end are respectively used to connect to a shock wave controller; the proximal end is closer to the operator than the distal end.

15. The shock wave generating device according to claim 1, wherein The electrode pair includes a first electrode and a second electrode. Each of the first electrodes and each of the second electrodes are respectively used to connect to a shock wave controller.

16. The shock wave generating device according to claim 14 or 15, characterized in that, The wire is attached to the tube body of the tubular member.

17. The shock wave generating device according to claim 1, characterized in that, 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. The coverage angle of the shock waves generated in at least three gaps in the circumferential direction of the tubular member is not less than 360°.

18. The shock wave generating device according to claim 17, wherein, 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 corresponding to the three electrode pairs have an included angle of 120° with each other in the circumferential direction.

19. The shock wave generating device according to claim 17, characterized in that, The multiple electrodes form at least two electrode groups arranged at intervals along the axial direction of the tubular member. 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.

20. The shock wave generating device according to claim 19, characterized in that, Among two adjacent electrode groups, there is a first electrode group at the proximal end of the tubular member and a second electrode group at the distal end of the tubular member. The first electrode group or / and the second electrode group includes at least two electrode pairs. The gaps formed in the first electrode group are misaligned in the circumferential direction with the gaps formed in the second electrode group. The proximal end of the tubular member is closer to the operator than the distal end of the tubular member.

21. The shock wave generating device according to claim 19, wherein, The multiple electrodes form multiple electrode groups. 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.

22. The shock wave generating device according to claim 21, wherein Two adjacent electrode groups are the same, and there is a misalignment between the two adjacent electrode groups in the circumferential direction.

23. The shock wave generating device according to claim 1, characterized in that, The tube body of the tubular member has an outer sidewall, the insulating protrusion is disposed on the outer sidewall, and the pair of electrodes is disposed on the outer sidewall.

24. The shock wave generating device according to claim 1, characterized in that, The tube body of the tubular member has a cavity, an outer sidewall and an inner sidewall, and the cavity is formed between the inner surface of the outer sidewall and the outer surface of the inner sidewall. Wherein, the insulating protrusion is connected between the inner surface and the outer surface, the pair of electrodes is disposed in the cavity, and the gap is formed in the cavity.

25. The shock wave generating device according to claim 24, wherein, A hollowed-out portion is provided on the outer sidewall, and at least a part of the hollowed-out portion in the circumferential direction of the tubular member is located radially outside the gap.

26. The shock wave generating device according to claim 1, characterized in that, The cross-sectional shape of the tubular member is circular or polygonal.

27. The shock wave generating device according to claim 1, wherein, The insulating protrusion is formed by an extrusion molding process of the pipe material.

28. The shock wave generating device according to claim 1, wherein, A breakdown portion extending in the axial direction of the tubular member is provided on the insulating protrusion, and the gap is formed on the breakdown portion.

29. The shock wave generating device according to claim 28, characterized in that, The breakdown portion is made of a material with a low breakdown field strength.

30. A shock wave balloon catheter, characterized in that, Comprising a catheter and a shock wave generating device according to any one of claims 1-29, the tubular member is formed on the catheter. And / or, the catheter comprises at least two sections, and the tubular member is connected between at least two sections of the catheter.

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