Shockwave balloon catheter

Abstract

This application relates to the field of interventional medical device technology and provides a shockwave balloon catheter, including a balloon, an inner tube, an outer tube, and an electrode assembly. The distal end of the inner tube passes through the lumen of the balloon and is sealed to the distal end of the balloon; the outer tube is sleeved on the inner tube, and the proximal end of the balloon is sealed to the distal end of the outer tube. The electrode assembly is used to generate a shockwave by energizing the inner tube, and the electrode assembly is connected to the inner tube located in the lumen. In this embodiment, an insulating layer is provided on the outer surface of the electrode assembly, and a discharge zone is formed by removing parts of the insulating layer on the outer surface of the electrode assembly. This insulating layer insulates the outer surface of the electrode assembly, allowing the charge on the electrode assembly to be concentrated in the discharge zone, thereby stably generating an electric arc and forming a stable shockwave that acts on the calcified vascular lesion, improving the surgical treatment effect.

Description

Technical Field

[0001] This application relates to the field of interventional medical device technology, and in particular to a shockwave balloon catheter. Background Technology

[0002] In the treatment of vascular calcification lesions, a shock wave balloon is usually delivered to the lesion site and then filled with conductive fluid. The built-in electrode instantly vaporizes and rapidly liquefies the conductive solution inside the balloon. The expansion and bursting of the bubbles generate mechanical shock waves at the treatment site, breaking up the calcified plaques in the blood vessel lumen and expanding the blood vessel lumen, thereby significantly improving vascular compliance.

[0003] In related technologies, shockwave balloon catheters have electrodes installed on the catheter inside the balloon. The electrodes are mostly integral conductive structures, but the charges distributed on the electrodes are disordered, randomly dispersed, and poorly concentrated, which leads to unstable arc generation and large fluctuations in the energy output of the shockwave, thus affecting the effectiveness of surgical treatment. Summary of the Invention

[0004] In view of this, the present invention provides a shockwave balloon catheter to solve the problem of uneven charge concentration on the electrodes affecting the treatment effect.

[0005] To solve the above problems, the technical solution of this application embodiment is implemented as follows: A shock wave balloon catheter includes: a balloon having an inner lumen; an inner tube, the distal end of which passes through the inner lumen and is sealed to the distal end of the balloon; an outer tube sleeved on the inner tube, forming a channel between the outer tube and the inner tube for introducing a filling medium into the inner lumen, the proximal end of the balloon being sealed to the distal end of the outer tube; and an electrode assembly for generating an arc pulse discharge in the filling medium between the two electrodes upon energization, the pulse discharge forming a plasma channel and triggering a violent expansion and explosion of the filling medium, thereby generating a shock wave, the electrode assembly being connected to the inner tube located in the inner lumen; wherein an insulating layer is disposed on the outer surface of the electrode assembly, and a discharge zone is formed on the outer surface of the electrode assembly by removing a portion of the insulating layer.

[0006] In some embodiments, the electrode assembly includes a distal electrode and a proximal electrode, and at least one conductive hole for electrical connection with a power supply wire is provided on the distal electrode and the proximal electrode respectively. The insulating layer and the discharge region are respectively provided on the distal electrode and the proximal electrode; wherein the distal electrode and the proximal electrode are sequentially arranged side by side on the inner tube.

[0007] In some embodiments, the electrode assembly further includes an intermediate electrode, on which the insulating layer and the discharge region are disposed; wherein the distal electrode, the intermediate electrode, and the proximal electrode are sequentially arranged side-by-side on the inner tube. In some embodiments, the distal electrode and the proximal electrode each have one discharge region, and the intermediate electrode has two discharge regions distributed at 180°; wherein the discharge region on the distal electrode and any one of the discharge regions on the intermediate electrode are disposed on the outer peripheral wall and face the same direction, and the discharge region on the proximal electrode and the other discharge region on the intermediate electrode are disposed on the outer peripheral wall and face the same direction; or, the distal electrode, the intermediate electrode, and the proximal electrode are sequentially spaced apart, the discharge region on the distal electrode and any one of the discharge regions on the intermediate electrode are respectively disposed on two sidewalls within the gap and are arranged opposite each other; the discharge region on the proximal electrode and the other discharge region on the intermediate electrode are respectively disposed on two sidewalls within the gap and are arranged opposite each other.

[0008] In some embodiments, the discharge regions respectively disposed on the distal electrode, the intermediate electrode and the proximal electrode are located at the axial center of the corresponding electrode, or at any edge of the two opposite ends of the axial direction, or connect the two opposite ends of the axial direction.

[0009] In some embodiments, a mounting structure is provided between the inner tube and the electrode assembly, the mounting structure being used to position the electrode assembly connected to the inner tube.

[0010] In some embodiments, the mounting structure includes a positioning groove formed on the outer wall of the inner tube, and the electrode assembly is engaged within the positioning groove.

[0011] In some embodiments, the mounting structure further includes a guide groove and a positioning block, wherein the guide groove is disposed on either the inner tube or the electrode group, and the positioning block is disposed on the other of the inner tube or the electrode group; wherein the positioning block slides along the guide groove into the positioning groove and abuts against the inner sidewall of the positioning groove.

[0012] In some embodiments, the guide groove is disposed on the outer side wall of the inner tube and extends at least along the axial direction of the inner tube to communicate with the positioning groove, and the positioning block is disposed on the inner wall of the electrode assembly; wherein, at least two guide grooves and two positioning blocks are respectively symmetrically arranged.

[0013] In some embodiments, at least two electrode groups are provided, all of which are disposed on the inner tube located in the inner cavity and are respectively close to the distal end and the proximal end of the balloon; wherein, the distal electrode close to the distal end of the balloon is connected to a high-voltage pulse generator via a first wire, the proximal electrode close to the distal end of the balloon is connected to the distal electrode close to the proximal end of the balloon via a second wire, and the proximal electrode close to the proximal end of the balloon is connected to the high-voltage pulse generator via a third wire.

[0014] In some embodiments, the electrode assembly further includes an insulating ring fitted onto the inner tube and located between the distal electrode and the proximal electrode.

[0015] In some embodiments, the electrode assembly further includes a first insulating ring and a second insulating ring, the first insulating ring being sleeved on the inner tube and located between the distal electrode and the intermediate electrode, and the second insulating ring being sleeved on the inner tube and located between the intermediate electrode and the proximal electrode.

[0016] In some embodiments, the axial length of at least one of the distal electrode, the intermediate electrode, the proximal electrode, the first insulating ring, and the second insulating ring is less than the radial wall thickness; and / or, the axial length of any one of the distal electrode, the intermediate electrode, and the proximal electrode is greater than or equal to the axial length of any one of the first insulating ring and the second insulating ring.

[0017] This application provides a shockwave balloon catheter, comprising a balloon, an inner tube, an outer tube, and an electrode assembly. The distal end of the inner tube passes through the lumen of the balloon and is sealed to the distal end of the balloon. The outer tube is fitted over the inner tube, and the proximal end of the balloon is sealed to the distal end of the outer tube. The electrode assembly is connected to the inner tube located within the lumen. This application employs an insulating layer on the outer surface of the electrode assembly, and by removing portions of the insulating layer on the outer surface of the electrode assembly, a discharge zone is formed. This insulating layer insulates the outer surface of the electrode assembly, allowing the charge on the electrode assembly to concentrate within the discharge zone, thereby stably generating an electric arc. This, in turn, generates a stable shockwave that acts on the calcified vascular lesion, improving the effectiveness of surgical treatment. Attached Figure Description

[0018] Figure 1 This is a schematic diagram of the structure of the shockwave balloon catheter provided in the embodiments of this application; Figure 2 This is a schematic diagram of the inner tube provided in an embodiment of this application; Figure 3 This is a schematic diagram of the structure of the first electrode assembly provided in the embodiments of this application; Figure 4This is a schematic diagram of the structure of the second type of electrode assembly provided in the embodiments of this application; Figure 5 This is a schematic diagram of the structure of the first type of distal electrode provided in the embodiments of this application; Figure 6 This is a schematic diagram of the structure of the second type of distal electrode provided in the embodiments of this application; Figure 7 This is a schematic diagram of the structure of the third type of distal electrode provided in the embodiments of this application; Figure 8 This is a schematic diagram of the structure of the first type of intermediate electrode provided in the embodiments of this application; Figure 9 This is a schematic diagram of the structure of the second type of intermediate electrode provided in the embodiments of this application; Figure 10 These are schematic diagrams of the structures of the three intermediate electrodes provided in the embodiments of this application; Figure 11 This is a schematic diagram of the structure of the first proximal electrode provided in the embodiments of this application; Figure 12 This is a schematic diagram of the structure of the second type of proximal electrode provided in the embodiments of this application; Figure 13 This is a schematic diagram of the structure of the third proximal electrode provided in the embodiments of this application; Figure 14 This is a schematic diagram of the structure of the first type of distal electrode in another set of electrode groups provided in the embodiments of this application; Figure 15 This is a schematic diagram of the structure of the second type of distal electrode in another set of electrode groups provided in the embodiments of this application; Figure 16 This is a schematic diagram of the structure of the third type of distal electrode in another set of electrode groups provided in the embodiments of this application; Figure 17 This is a schematic diagram of the structure of the first insulating ring or the second insulating ring provided in the embodiments of this application.

[0019] Explanation of reference numerals in the attached figures: 1. Shockwave balloon catheter; 10. Channel; 11. Balloon; 110. Inner lumen; 12. Inner tube; 120. Guide wire lumen; 121. Mounting structure; 1211. Positioning groove; 1212. Guide groove; 1213. Positioning block; 13. Outer tube; 14. Electrode assembly; 1400. Insulating layer; 1401. Discharge zone; 141. Distal electrode; 142. Intermediate electrode; 143. Proximal electrode; 144. Conductive hole; 145. Protrusion; 146. Through hole; 1471. First conductor; 1472. Second conductor; 1473. Third conductor; 148. First insulating ring; 149. Second insulating ring; 16. Imaging ring; 17. Guide head; 18. Catheter seat; 19. Hypoallergenic tube; 21. High-voltage pulse generator. Detailed Implementation

[0020] To make the objectives, technical solutions, and advantages of this application clearer, the application will be further described in detail below with reference to the accompanying drawings. The described embodiments should not be regarded as limitations on this application. All other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0021] The specific technical features described in the specific embodiments can be combined in any suitable manner without contradiction. For example, different combinations of specific technical features can form different embodiments and technical solutions. To avoid unnecessary repetition, the various possible combinations of the specific technical features in this application will not be described separately.

[0022] In the following description, the terms “first, second, third, ……” are used only to distinguish similar objects and do not represent a specific ordering of objects. It is understood that “first, second, third, ……” may be interchanged in a specific order or sequence where permitted, so that the embodiments of this application described herein can be implemented in an order other than that illustrated or described herein.

[0023] It should be understood that the directional descriptions "above", "below", "outside" and "inside" involved in the embodiments of this application refer to the directional descriptions under normal use. The "left" and "right" directions refer to the left and right directions shown in the corresponding schematic diagrams. They can be the left and right directions under normal use or not.

[0024] It should be noted that the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Unless otherwise specified, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes that element. "A plurality of" means two or more.

[0025] Unless otherwise defined, all technical and scientific terms used in the embodiments of this application have the same meaning as commonly understood by one of ordinary skill in the art. The terminology used in the embodiments of this application is for descriptive purposes only and is not intended to limit the scope of this application.

[0026] like Figure 1As shown in the embodiment of this application, a shockwave balloon catheter 1 can be used at least to intervene in a blood vessel with calcified lesions. When energized, it generates shockwaves that act on the calcified lesion tissue, thereby breaking up the calcified lesion tissue and achieving the purpose of treating the calcified blood vessel. In related technologies, shockwave balloon catheters suffer from large fluctuations in shockwave energy output due to the disordered charge distribution on the electrodes. Therefore, to improve the problem of large fluctuations in shockwave energy output, the shockwave balloon catheter 1 provided in this embodiment of the application insulates the electrodes, allowing for concentrated discharge and thus ensuring a stable output of shockwave energy, improving the treatment effect.

[0027] In this article, the term "distal" refers to the end of the shockwave balloon catheter 1 that is inserted into the blood vessel or the end that is close to the site of treatment. "Proximal" refers to the end of the shockwave balloon catheter 1 that is close to the operator or the end that is connected to the operating device.

[0028] like Figure 1 and Figure 2 As shown in the embodiment of this application, a shock wave balloon catheter 1 includes a balloon 11, an inner tube 12, an outer tube 13, and an electrode assembly 14. The balloon 11 has an inner cavity 110, and the distal end of the inner tube 12 passes through the inner cavity 110 and is sealed to the distal end of the balloon 11. The outer tube 13 is sleeved on the inner tube 12, and a channel 10 for introducing a filling medium into the inner cavity 110 is formed between the outer tube 13 and the inner tube 12. The proximal end of the balloon 11 is sealed to the distal end of the outer tube 13. The electrode assembly 14 is connected to the inner tube 12 located in the inner cavity 110. The electrode assembly 14 is used to generate an arc pulse discharge in the filling medium between the two electrodes. The pulse discharge forms a plasma channel and causes the filling medium to expand and burst violently, thereby generating a shock wave. The electrode assembly 14 is connected to the inner tube 12 located in the inner cavity 110 so that it can discharge at a relatively stable position inside the balloon 11 and ultimately obtain a shock wave with mechanical energy. An insulating layer 1400 is provided on the outer surface of the electrode assembly 14, and a discharge region 1401 is formed on the outer surface of the electrode assembly 14 by removing a portion of the insulating layer 1400. In this way, the charge on the electrode assembly 14 can be concentrated in the discharge region 1401 and will not be randomly distributed, thereby stably generating an electric arc, which can then form a stable shock wave that acts on the calcified lesion of the blood vessel, thus improving the effect of surgical treatment.

[0029] Specifically, balloon 11 is made of semi-compliant material Pebax (Chinese name: polyether block polyamide) or non-compliant material nylon. Balloon 11 has an inner lumen 110, which can be inflated by injecting a conductive filling medium. This allows the inner lumen 110 to expand upon filling with the medium or shrink upon deflating. The burst pressure of balloon 11 can reach up to 24 atm (atm, atmospheric pressure). This high burst pressure reduces the risk of balloon 11 rupture during surgery, improving surgical safety. When uninflated, balloon 11 is in a low-profile folded state for easy intravascular delivery. Upon reaching the calcified lesion site, its inner lumen 110 can be filled with a filling medium (such as saline or diluted contrast agent) to expand and adhere to the vessel wall.

[0030] The inner tube 12 can be a multi-layered composite hollow tube composed of PTFE (PTFE is an abbreviation for Polytetrafluoroethylene), PE (PE is an abbreviation for Polyethylene), Pebax (polyether block polyamide), or nylon. The inner layer is a PTFE layer, which has an extremely low coefficient of friction, facilitating the passage of the guidewire during surgery. The outermost layer is a Pebax or nylon layer, providing sufficient support strength and thus improving overall maneuverability. The distal end of the inner tube 12 passes through the inner lumen 110. This can be achieved by having the end of the inner tube 12 remain within the inner lumen 110 and be sealed to the distal end of the balloon 11; or by having part of the end of the inner tube 12 protrude from the balloon 11 and then be sealed to the distal end of the balloon 11, thus preserving the overall seal of the inner lumen 110. The sealing connection between the distal end of the balloon 11 and the inner tube 12 can be achieved through welding, gluing, or thermal fusion.

[0031] The outer tube 13 may be a hollow tube extruded from nylon material, so that the outer tube 13 is fitted onto the inner tube 12, forming a channel 10 between the outer tube 13 and the inner tube 12 for introducing filling medium into the inner cavity 110. That is, the diameter of the outer tube 13 is larger than the outer diameter of the inner tube 12, thus forming a gap between the outer tube 13 and the inner tube 12, which can at least be used to introduce filling medium (such as physiological saline) into the inner cavity 110 of the balloon 11. The proximal end of the balloon 11 can be sealed to the distal end of the outer tube 13 by welding, gluing, or heat fusion. In this way, both the distal and proximal ends of the balloon 11 are sealed, so that the inner cavity 110 is only connected to the channel 10. The filling medium can be introduced into the inner cavity 110 through the channel 10, the balloon 11 is inflated, or the filling medium in the inner cavity 110 is discharged through the channel 10, and the balloon 11 shrinks. Channel 10 can also be used for wiring of the connecting electrode group 14, so that the wires are confined between the outer wall of the inner tube 12 and the inner wall of the outer tube 13, the wiring is neat and will not cause an increase in the overall size of the outer tube 13, thus achieving better passability.

[0032] Electrode assembly 14 is connected to inner tube 12 located within lumen 110. Electrode assembly 14 typically includes at least one pair of electrodes with opposite polarities, which are electrically connected to a proximal high-voltage pulse generator 21 via wires passing through inner tube 12 and / or outer tube 13. When filling medium is injected into lumen 110 of balloon 11 and a high-voltage pulse is applied, an electric spark is generated between the electrodes, instantly vaporizing the surrounding liquid to form bubbles. The bubbles then violently collapse, generating a shock wave. The energy of the shock wave is released in the target segment of balloon 11, thereby effectively acting on the calcified lesion, breaking up the calcified plaque in the lumen 110, and dilating the lumen of the blood vessel, thereby achieving the therapeutic purpose of improving vascular compliance.

[0033] In this embodiment, an insulating layer 1400 is provided on the outer surface of the electrode assembly 14, and a discharge region 1401 is formed on the outer surface of the electrode assembly 14 by removing a portion of the insulating layer 1400. This discharge region 1401 is one or more exposed windows on the insulating layer 1400, and the exposed electrode metal surface beneath it is the effective discharge site. The insulating layer 1400 concentrates any randomly distributed surface charges on the electrode assembly 14 into the discharge region 1401. This concentration of charges within the discharge region 1401 ensures a more consistent starting voltage and energy density for each breakdown discharge, resulting in a more stable arc in terms of position, shape, and intensity. Furthermore, the stable arc directly leads to more controllable bubble formation and collapse processes, resulting in a stable and less fluctuating shock wave energy output. Consequently, the shock wave energy can act more uniformly and precisely on the vascular calcification lesion, significantly improving the safety and effectiveness of surgical treatment.

[0034] In the above description, "forming the discharge region 1401 on the outer surface of the electrode assembly 14 by removing a portion of the insulating layer 1400" means that an insulating layer 1400 can be first provided on the entire outer surface of the electrode assembly 14, and then, according to the needs of the discharge position, the insulating material can be removed at the corresponding position on the electrode assembly 14, exposing the internal metal part to form the discharge region 1401. Alternatively, when providing the insulating layer 1400, the position on the electrode assembly 14 where the discharge region 1401 needs to be formed can be covered, so that no insulating material is provided at this position, while the insulating layer 1400 is provided at other positions except for this position.

[0035] The insulating layer 1400 can be set on the electrode assembly 14 by means of magnetron sputtering, printing, 3D printing, electroplating or vapor deposition, or by coating or sintering. There are various ways to set it, and you can choose flexibly.

[0036] This application provides a shockwave balloon catheter 1, comprising a balloon 11, an inner tube 12, an outer tube 13, and an electrode assembly 14. The distal end of the inner tube 12 passes through the inner cavity 110 of the balloon 11 and is sealed to the distal end of the balloon 11. The outer tube 13 is sleeved on the inner tube 12, and the proximal end of the balloon 11 is sealed to the distal end of the outer tube 13. The electrode assembly 14 is connected to the inner tube 12 located in the inner cavity 110. A channel 10 for introducing a filling medium into the inner cavity 110 is formed between the outer tube 13 and the inner tube 12. This application embodiment employs an insulating layer 1400 on the outer surface of the electrode assembly 14, and a discharge region 1401 is formed on the electrode assembly 14 by partially removing the insulating layer 1400. This design allows most of the electrode surface to be physically covered by the insulating layer 1400, exposing only the metal of the electrode in the discharge region 1401, forcing all discharge to be concentrated within the discharge region 1401, thereby concentrating scattered charges. The concentrated charge ensures that the generated arc maintains good consistency in position, shape, and starting voltage during each breakdown discharge. This stable and controllable arc leads to a more uniform and predictable vaporization and bubble collapse process of the filling medium, ultimately resulting in a shock wave with stable and uniform energy distribution. This method of generating a stable arc by concentrating the charge, and then forming a uniform and reliable shock wave, ensures that the mechanical energy applied to the calcified vascular lesion is more precise and reliable, fundamentally improving the safety and effectiveness of surgical treatment.

[0037] In some embodiments, such as Figure 1 , Figure 3 and Figure 4As shown, the electrode assembly 14 includes a distal electrode 141 and a proximal electrode 143. The materials of each electrode (the collective term for the distal electrode 141 and the proximal electrode 143) can be nickel-titanium alloy, stainless steel, platinum, titanium and titanium alloys, tungsten-copper alloy, etc. Each electrode can be cut from tubing or sheet metal, and its internal shape matches the external shape of the inner tube 12 to be fitted and installed. Each electrode has a positioning block 1213 on its inner wall for positioning and installation. At least the distal electrode 141 and the proximal electrode 143 each have a conductive hole 144 for electrical connection with a power supply wire, allowing the power supply wire to be passed through the conductive hole 144 to supply power to the corresponding electrode.

[0038] Specifically, the distal electrode 141 and the proximal electrode 143 are sequentially arranged and sleeved on the inner tube 12. That is, when inserting the electrodes from the distal end of the inner tube 12, the proximal electrode 143 can be inserted first, followed by the distal electrode 141, so that the electrodes are arranged side by side along the axial direction of the inner tube 12. In this way, arranging the electrodes side by side instead of stacking them coaxially reduces the profile of the folded balloon 11, resulting in better permeability and allowing the shockwave balloon catheter 1 to reach narrower, calcified lesion sites.

[0039] In some embodiments, such as Figure 1 , Figure 3 and Figure 4 As shown, the electrode assembly also includes an intermediate electrode 142, on which an insulating layer 1400 and a discharge region 1401 are disposed. Specifically, when the intermediate electrode 142 is provided, it is positioned between the distal electrode 141 and the proximal electrode 143. Thus, when energized, pulsed discharges can be formed between the distal electrode 141 and the intermediate electrode 142, and between the intermediate electrode 142 and the proximal electrode 143, thereby generating shock waves. The direction of the generated shock waves can be adjusted by adjusting the position of the pulsed discharges, enabling the generation of shock waves in the same and / or different directions. In other words, the combination of the distal electrode 141, the intermediate electrode 142, and the proximal electrode 143 can generate multi-point, multi-directional shock waves, improving the efficiency of calcified tissue fragmentation and the safety of treatment.

[0040] Specifically, when the electrode assembly 14 is configured to include an intermediate electrode 142, the distal electrode 141, intermediate electrode 142, and proximal electrode 143 are sequentially arranged side-by-side on the inner tube 12. This avoids increasing the radial dimension, allowing the balloon 11 to maintain a small profile even after folding, resulting in good permeability and facilitating the shockwave balloon catheter 1 to reach narrower, calcified lesion locations.

[0041] In some embodiments, such as Figures 3 to 16As shown, an insulating layer 1400 and a discharge region 1401 are respectively provided on the distal electrode 141, the intermediate electrode 142, and the proximal electrode 143. Specifically, during installation, an insulating layer 1400 is provided on the surface of each electrode except for the conductive hole 144, and the thickness of each insulating layer 1400 is generally between 0.001-0.5 mm. In this way, the insulating layer 1400 prevents direct conduction between the side-by-side electrodes. At the same time, according to the design requirements, a discharge region 1401 is formed at the corresponding position of each electrode by partially removing the insulating layer 1400. This region is used for charge accumulation to generate a stable shock wave. The insulating layer 1400 has anti-electrical breakdown characteristics and can be formed with a preset thickness from materials such as ceramics, Parylene, and polytetrafluoroethylene (PTFE), thereby creating a safe breakdown distance between the electrodes and allowing the electrodes to discharge in the designed manner.

[0042] In some embodiments, such as Figures 5 to 16As shown, a discharge region 1401 is provided on the distal electrode 141 and the proximal electrode 143, while two discharge regions 1401 are provided on the intermediate electrode 142, distributed at 180°. The discharge regions 1401 on the distal electrode 141 and either of the discharge regions 1401 on the intermediate electrode 142 are both located on the outer peripheral wall and face the same direction. Similarly, the discharge regions 1401 on the proximal electrode 143 and the other discharge region 1401 on the intermediate electrode 142 are both located on the outer peripheral wall and face the same direction. With this arrangement, each discharge region 1401 is located on the outer peripheral wall of its corresponding electrode and faces the same direction (towards the inner wall of the balloon 11). Adjacent electrodes can either abut against each other or have a gap between them. Of course, as another possible implementation, the distal electrode 141, the intermediate electrode 142, and the proximal electrode 143 can be sequentially and alternately arranged on the inner tube 12. The discharge area 1401 on the distal electrode 141 and any one of the discharge areas 1401 on the intermediate electrode 142 are respectively arranged on two side walls within the gap and are kept opposite each other. Similarly, the discharge area 1401 on the proximal electrode 143 and another discharge area 1401 on the intermediate electrode 142 are respectively arranged on two side walls within the gap and are kept opposite each other. In this arrangement, because there is a gap between two adjacent electrodes, there will be no short circuit between the two opposite discharge areas 1401. Therefore, the two configurations described above ultimately enable the generation of a first electric arc between the discharge area 1401 on the intermediate electrode 142 and the discharge area 1401 on the distal electrode 141 after energization, and a second electric arc between the other discharge area 1401 on the intermediate electrode 142 and the discharge area 1401 on the proximal electrode 143 after energization. The first and second electric arcs are oriented in opposite directions and lie in the same plane, thus enabling impact treatment of the calcified lesion from different directions, which is beneficial for breaking up the calcified tissue and achieving a better therapeutic effect. Of course, it is understandable that by setting different numbers of discharge areas 1401 at other locations on each electrode, electric arcs oriented in different directions can be formed, further enhancing the therapeutic effect.

[0043] Specifically, such as Figure 5 As shown, the discharge region 1401 can be located at the center of the electrode axis; or as... Figure 6 As shown, it can also be completely removed axially to the edges at both ends, or as... Figure 7As shown, the discharge zone 1401 is positioned at either of the two opposite edges along the axial direction. The outline shape of the discharge zone 1401 can be circular, rectangular, or elliptical, or it can be customized depending on its location. For example, when the discharge zone 1401 is positioned at the edge of the electrode end face, it can be semi-circular, arc-shaped, or rectangular. The specific location and shape can be selectively designed based on the required location or intensity of the shock wave. The differentiated design of the shape and location of the discharge zone 1401 allows for active control of the electric field distribution, arc characteristics, and the final shock wave pattern. Furthermore, it can be matched to the morphology of the calcified lesion for targeted treatment, improving the precision of the treatment effect.

[0044] In some embodiments, such as Figure 1 and Figure 2 As shown, a mounting structure 121 is provided between the inner tube 12 and the electrode assembly 14. The mounting structure 121 is used to position the electrode assembly 14 connected to the inner tube 12, so that the electrode assembly 14 can be firmly installed in the preset position of the inner tube 12. Therefore, when the balloon 11 is located at the vascular lesion site, the shock wave generated by the electrode assembly 14 can accurately act on the lesion site for treatment, improving the safety and effectiveness of the treatment. Specifically, the mounting structure 121 is used to precisely and firmly position and connect the electrode assembly 14 to a predetermined position on the outer surface of the inner tube 12 in the axial and / or circumferential directions. This mechanically restricts the positional movement of the electrode assembly 14 relative to the inner tube 12. This ensures that the electrode assembly 14 can be stably held in the designed position regardless of the friction and torque experienced when the catheter bends and moves through the blood vessel, or the severe mechanical vibration generated by the pulse discharge. This ensures that during treatment, the energy of the shock wave is always precisely released to the target segment of the balloon 11, thereby effectively acting on the vascular calcification lesion, greatly improving the controllability and effectiveness of the treatment.

[0045] Specifically, the mounting structure 121 may be a raised annular rib or boss, or a recessed annular groove or pit, machined on the outer wall of the inner tube 12. The inner diameter of the electrode assembly 14 (such as an electrode ring) is adapted to these protrusions or grooves, and fixed by interference fit, snap-fit, or fitting. In one possible embodiment, the mounting structure 121 includes at least one limiting protrusion protruding outward from the outer wall of the inner tube 12, and the proximal and / or distal end faces of the electrode assembly 14 (such as an electrode ring) can abut against the sidewall of the limiting protrusion protrusion to achieve axial positioning. Two spaced limiting protrusions can form a groove to confine the electrode assembly 14 within the groove, thereby preventing axial movement. The limiting protrusions can be formed by thermoforming, molding, or welding additional annular components to the outer wall of the inner tube 12. In another possible implementation, the mounting structure 121 may include an annular groove formed on the outer wall of the inner tube 12, with an inwardly protruding retaining block or the entire electrode ring embedded in the groove on the electrode assembly 14. This design allows the outer surface of the electrode assembly 14 to be flush with the outer wall of the inner tube 12, reducing flow resistance and potential snagging risks. The mounting structure 121 may also be a mounting sleeve fitted and fixed to the outer wall of the inner tube 12. The mounting sleeve can be fixed to the inner tube 12 by welding or threaded connection, while the electrode assembly 14 is positioned and installed to the mounting sleeve by steps or threads. This design, which separates the positioning element of the electrode assembly 14 from the inner tube 12, improves the flexibility of the mounting sleeve installation. Of course, it is understandable that the mounting structure 121 can also be a combination of designs set on the outer wall of the inner tube 12 and set inside the electrode assembly 14, such as pre-designing roughened bonding areas on the electrode assembly 14 and the inner tube 12 respectively, and then using UV glue (UV is an abbreviation for Ultraviolet Rays, and UV glue is also known as shadowless glue or photosensitive glue) to achieve a fixed connection between the two.

[0046] In some embodiments, such as Figures 2 to 4As shown, the mounting structure 121 includes a positioning groove 1211. The positioning groove 1211 is formed on the outer wall of the inner tube 12, and the electrode assembly 14 is fitted into the positioning groove 1211. Specifically, the positioning groove 1211 is formed on the outer wall of the inner tube 12, that is, a local recessed area directly formed on the outer surface of the inner tube 12 by cutting, etching, or laser processing. The electrode assembly 14 is fitted into the positioning groove 1211 accordingly. The positioning groove 1211 provides a accommodating space with positional boundaries for the electrode assembly 14 in the axial and / or circumferential directions. When the electrode assembly 14 is installed in the positioning groove 1211, its degrees of freedom are directly restricted by the groove wall, thereby limiting the possibility of the electrode assembly 14 sliding axially or rotating circumferentially on the outer wall of the inner tube 12. Compared to conventional methods of simple mounting or localized adhesive application, the positional accuracy of the electrode assembly 14, which is secured within the positioning groove 1211, is guaranteed by the machining precision of the positioning groove 1211. Mechanical interlocking provides reliable fixation, ensuring that the stability of the fixation does not depend on adhesives or friction. This ensures the absolute stability of the electrode's spatial position under complex conditions such as bending and torsion during catheter delivery and repeated vibrations caused by shock waves, thereby guaranteeing the precision of the treatment site.

[0047] The positioning groove 1211 can be a partial arc segment formed on the outer side wall of the inner tube 12 along its circumferential direction, or it can be arranged around the entire circumference. The electrode assembly 14 can slide and engage with the positioning groove 1211 by the elastic deformation of the inner tube 12. The opening of the positioning groove 1211 can be provided with a guide slope to facilitate the engagement of the electrode assembly 14. The depth of the positioning groove 1211 is sufficient to effectively limit the position of the electrode assembly 14 without compromising the sealing of the inner tube 12. The axial width of the positioning groove 1211 and the axial thickness of the electrode assembly 14 form an interference fit or a small clearance fit, allowing the electrode assembly 14 to abut against the inner wall of the positioning groove 1211 at both ends in the axial direction, achieving tight axial positioning.

[0048] In some embodiments, such as Figures 2 to 4As shown, the mounting structure 121 also includes a guide groove 1212 and a positioning block 1213. The guide groove 1212 is disposed on either the inner tube 12 or the electrode assembly 14, and the positioning block 1213 is disposed on the other of the inner tube 12 or the electrode assembly 14. Thus, the positioning block 1213 can slide along the guide groove 1212 into the positioning groove 1211 and abut against the inner wall of the positioning groove 1211. Specifically, the depth of the guide groove 1212 in the radial direction of the inner tube 12 is generally less than or equal to the depth of the positioning groove 1211, and the guide groove 1212 provides a preset sliding path for the installation of the positioning block 1213. When installing the electrode assembly 14, the operator can smoothly and accurately guide the electrode assembly 14 to the predetermined installation position by sliding the positioning block 1213 along the guide groove 1212. After the positioning block 1213 slides into the positioning groove 1211, the positioning block 1213 can be abutted against the inner wall of the positioning groove 1211 by the elastic reset of the inner tube 12; or, after the positioning block 1213 slides into the positioning groove 1211, the positioning block 1213 can be misaligned with the guide groove 1212 by rotating the conductive component, so that the end face of the positioning block 1213 abuts against the inner wall of the positioning groove 1211. This abutting relationship constitutes mechanical limiting and fixing, thereby realizing the position limitation of the conductive component, which can effectively prevent the electrode group 14 from moving along the axial direction of the inner tube 12 due to the impact of the shock wave, and significantly improve the stability of the shock wave.

[0049] The “inner wall” mentioned above usually refers to the side of the main limiting groove 1211 formed in the axial direction.

[0050] This design, through the cooperation of the guide groove 1212 and the positioning block 1213, not only provides guidance for the installation of the electrode assembly 14, improving the ease of assembly, but also allows the positioning block 1213 to slide from the guide groove 1212 into the positioning groove 1211, and then be rotated to misalign with the guide groove 1212 (if the positioning block 1213 and the guide groove 1212 are not aligned, the positioning block 1213 cannot slide directly into the guide groove 1212), thereby enabling the end face of the positioning block 1213 to abut against the side wall of the positioning groove 1211 for reliable positioning. The guide groove 1212 can extend in a straight line or a curve, with flexible design, allowing the positioning block 1213 to slide smoothly along the guide groove 1212 into the positioning groove 1211.

[0051] In some embodiments, such as Figure 2As shown, a guide groove 1212 is disposed on the outer wall of the inner tube 12 and extends along the axial direction of the inner tube 12 to at least communicate with the positioning groove 1211. Alternatively, the guide groove 1212 can extend linearly from either the distal or proximal end of the inner tube 12 until it connects with the positioning groove 1211, or it can extend from the distal to the proximal end of the inner tube 12, along the entire length of the inner tube 12, and connect with the positioning groove 1211 at some intermediate position. The positioning block 1213 is disposed on the inner wall of the electrode assembly 14, so that when the electrode assembly 14 is installed onto the inner tube 12, the positioning block 1213 on the electrode assembly 14 aligns with the guide groove 1212 on the inner tube 12 and slides in.

[0052] Specifically, to improve the reliability of the positioning effect, at least two guide grooves 1212 and two positioning blocks 1213 can be symmetrically arranged. That is, two guide grooves 1212 are symmetrically arranged on the outer wall of the inner tube 12, and the two guide grooves 1212 are distributed at a 180° angle around the circumference of the inner tube 12. Correspondingly, two positioning blocks 1213 are symmetrically arranged on the inner wall of the electrode assembly 14, and the two positioning blocks 1213 are distributed at a 180° angle. Thus, the two positioning blocks 1213 and the two guide grooves 1212 can correspond one-to-one, providing reliable guidance for the installation of the electrode assembly 14. After installation, the reliability of the limiting is improved by the joint limiting of the two positioning blocks 1213. Of course, it is understandable that the guide grooves 1212 and the positioning blocks 1213 can also be set to the same number, or the number of guide grooves 1212 can be greater than the number of positioning blocks 1213, so that the corresponding guide grooves 1212 can be selected to match and install with the positioning blocks 1213 according to the installation requirements.

[0053] Specifically, the electrode assembly 14 is installed by fitting it onto the inner tube 12, thus the electrode assembly 14 has holes through which the inner tube 12 passes. During installation, the diameter of the holes on the electrode assembly 14 is equal to the outer diameter of the inner tube 12, and the diameter of the hole formed between the two opposing positioning blocks 1213 is directly equal to that of the positioning groove 1211, thereby enabling smooth assembly and stable positioning after installation.

[0054] In some embodiments, to further ensure the stability of the electrode assembly 14 mounted on the inner tube 12, it is also used to position and fix the electrode assembly 14 at both ends with medical adhesive or heat shrink tubing, which can further prevent the position of the electrode assembly 14 from shifting.

[0055] In some embodiments, such as Figures 2 to 4As shown, at least two sets of electrode groups 14 are provided. All electrode groups 14 are disposed on the inner tube 12 located in the inner cavity 110, and are respectively close to the distal end and proximal end of the balloon 11. Simultaneously, the distal electrode 141 near the distal end of the balloon 11 is connected to the high-voltage pulse generator 21 via a first wire 1471, and the proximal electrode 143 near the distal end of the balloon 11 is connected to the distal electrode 141 near the proximal end of the balloon 11 via a second wire 1472. The proximal electrode 143 near the proximal end of the balloon 11 is connected to the high-voltage pulse generator 21 via a third wire 1473. Specifically, by providing at least two sets of electrode groups 14, shock waves with different directions of force can be generated during treatment, thereby improving the treatment effect. With two sets of electrode groups 14, the first wire 1471 and the third wire 1473 both extend from the proximal end of the outer tube 13 to facilitate positive and negative connection with the high-voltage pulse generator 21. When there are two or more electrode groups 14, they can be connected in series and energized by wires. To facilitate the wiring of the first wire 1471 without increasing the overall radial dimension of the balloon 11, through holes 146 are provided on the intermediate electrode 142 and the proximal electrode 143. These through holes 146 penetrate the axial thickness of the intermediate electrode 142 and the proximal electrode 143, allowing the first wire 1471 to pass through the interior of the respective electrode. This not only avoids increasing the radial dimension of the balloon 11 but also fixes the position of the first wire 1471. The diameter of the through hole 146 is equal to the outer diameter of the first wire 1471, allowing the first wire 1471 to pass through.

[0056] Specifically, the diameter of the conductive hole 144 provided on the corresponding electrode is 0.9-1 times the diameter of the conductor core to be electrically connected, so that the conductor core and the inside of the conductive hole 144 can be kept in close contact, which can prevent the conductor from falling off and increase the stability of current and voltage transmission.

[0057] In the electrode assembly 14 located near the proximal end of the balloon 11, each electrode is provided with a through hole 146 for the first lead wire 1471 to pass through. Simultaneously, a third electric arc is generated between the discharge area 1401 on the distal electrode 141 and one discharge area 1401 on the intermediate electrode 142 after energization. A fourth electric arc is generated between the other discharge area 1401 on the intermediate electrode 142 and the discharge area 1401 on the proximal electrode 143 after energization. The third and fourth electric arcs face opposite directions and lie in the same plane, but are perpendicular to the plane containing the first and second electric arcs. This distribution of four electric arcs facilitates the uniform application of shock waves to the surface of the balloon 11, thereby uniformly fragmenting calcified lesions.

[0058] Specifically, such as Figures 14 to 16As shown, in the electrode group 14 located near the proximal end of the balloon 11, the discharge area 1401 on the distal electrode 141 is distributed at a 90° angle to the through hole 146 through which the first wire 1471 passes. Similarly, the discharge area 1401 on the proximal electrode 143 is also distributed at a 90° angle to the through hole 146 through which the first wire 1471 passes. This ensures that the wiring of the wires and the positions of each discharge area 1401 do not interfere with each other, allowing each area to reliably perform its respective function.

[0059] Specifically, except for the discharge area 1401 and the conductive hole 144, which are not provided with an insulating layer 1400, all other parts of each electrode are provided with an insulating layer 1400 to ensure good safety insulation between the electrodes. Furthermore, this increases the degree of charge accumulation, thereby forming a stable electric arc and improving the therapeutic effect.

[0060] In some embodiments, when the electrode assembly 14 includes a distal electrode 141 and a proximal electrode 143, the electrode assembly 14 further includes an insulating ring (not shown in the figure), which is sleeved on the inner tube 12 and located between the distal electrode 141 and the proximal electrode 143. By providing an insulating ring between the distal electrode 141 and the proximal electrode 143, current leakage, short circuits, or discharges in non-target areas between the electrodes can be avoided, better ensuring that the shock wave is generated only between the preset electrode pairs, thereby ensuring the safety and effectiveness of the treatment.

[0061] In some embodiments, such as Figure 4 and Figure 17 As shown, when the electrode assembly 14 is configured to include a distal electrode 141, an intermediate electrode 142, and a proximal electrode 143, the electrode assembly 14 also includes a first insulating ring 148 and a second insulating ring 149. The first insulating ring 148 and the second insulating ring 149 have essentially the same shape and are made of the same material. The first insulating ring 148 is fitted onto the inner tube 12 and is located between the distal electrode 141 and the intermediate electrode 142. The second insulating ring 149 is fitted onto the inner tube 12 and is located between the intermediate electrode 142 and the proximal electrode 143. The insulating rings (the collective term for the first insulating ring 148 and the second insulating ring 149) are fitted side-by-side with the electrodes onto the inner tube 12. This not only avoids increasing the overall radial dimension of the balloon 11, but also maintains a predetermined safe insulating distance between adjacent electrodes through the insulating rings, thereby increasing the stability of the shock wave.

[0062] With the insulating rings in place, the thickness of the insulating layer 1400 on each electrode can be set to 0.001-0.05 mm, taking advantage of the insulation provided by the insulating rings. Furthermore, protrusions 145 corresponding to the guide grooves 1212 can be provided on the inner wall of each insulating ring, with the inner diameter of the protrusions 145 equal to the outer diameter of the positioning grooves 1211. This ensures a tight fit between the insulating rings and the positioning grooves 1211, increasing the stability of the electrode assembly 14 after installation. The insulating rings can be made of polyimide, polyurethane, nylon (PA), polyethylene (PE), or mixtures thereof, and can be cut from pipes or sheets. Moreover, when insulating rings are placed between adjacent electrodes, the positions of the discharge areas 1401 on each electrode can be determined as follows: Figures 5 to 13 The design approach is flexible, as shown in any of the methods.

[0063] When no insulating ring is provided between two adjacent electrodes, the thickness of the insulating layer 1400 on the end face of each electrode (the two sides along the axial direction of the inner tube 12 after installation) should be at least 0.01-0.5 mm to form a safe breakdown distance and improve the stability of the function of each electrode. Furthermore, when no insulating ring is provided between two adjacent electrodes, the position of the discharge area 1401 on each electrode can be as follows: Figure 5 , Figure 8 or Figure 11 As shown, each discharge region 1401 is positioned at the center of the electrode axis, thus providing sufficient safety distance for stable discharge.

[0064] Specifically, the inner diameter formed by the positioning block 1213 on each electrode or the inner diameter formed by the protrusion on each insulating ring is equal to the outer diameter of the positioning groove 1211; the inner diameter of each electrode or the inner diameter of each insulating ring is equal to the outer diameter of the inner tube 12, thereby improving the stability of electrode fixation and giving the balloon 11 a smooth and natural outer contour after folding, so that the catheter can pass through calcified lesions more easily, improving the safety of surgical operation and the comfort of the patient during the operation.

[0065] Specifically, when two sets of electrode groups 14 are provided (one near the distal end of the balloon 11 and the other near the proximal end of the balloon 11, respectively; "near" means, for example, near the distal end of the balloon 11, indicating that the distance between the electrode closest to the distal end of the balloon 11 in the corresponding electrode group 12 and the distal end of the balloon 11 is within a preset range, such as 0.5-2cm), the specific structures of the distal electrode 141, intermediate electrode 142, and proximal electrode 143 included in each electrode group 14, or the first insulating ring 148 and the second insulating ring 149, are basically set according to the above-described arrangement. However, since wire connection and wiring are required, each electrode and insulating ring can also be designed with corresponding conductive holes 144 and wire-passing holes 146 according to the actual wiring and electrical connection requirements. For example, in the electrode group 14 near the proximal end of the balloon 11, the distal electrode 141 needs to be electrically connected to the second wire 1472 and also needs to allow the first wire 1471 to pass through. Therefore, a conductive hole 144 and a wire passage hole 146 are provided on the distal electrode 141 at this location. Thus, the distal electrode 141 in the electrode group 14 near the distal end of the balloon 11 differs from the distal electrode 141 in that it has an additional wire passage hole 146. However, this structural difference does not affect the realization of its basic discharge function. Therefore, it can be understood that although the two distal electrodes 141 have structural differences, they both belong to the electrodes located at the distal end of the corresponding electrode group 14, and are therefore both called distal electrodes 141. That is, provided that the basic function is satisfied and their positions in each group are the same, they can both be called distal electrodes. Similarly, if the intermediate electrodes 142 and proximal electrodes 143 also have the above situation, they can be understood using the above explanation, and will not be elaborated further here. That is, when the names are the same and the actual functions are the same, structural differences are allowed. Furthermore, this also applies when there are three, four, or more electrode groups 14, and electrical connections are required between adjacent electrode groups 14. When conductive holes 144 and wire-passing holes 146 (such as near-end electrode 143) are simultaneously provided on the corresponding electrodes, the positional relationship between the conductive holes 144 and wire-passing holes 146 is not strictly limited, as long as the electrical connection and wiring requirements are met. For example, the conductive holes 144 and wire-passing holes 146 can be arranged at a 90° or 180° angle.

[0066] In some embodiments, the axial length of at least one of the distal electrode 141, intermediate electrode 142, proximal electrode 143, first insulating ring 148, and second insulating ring 149 is less than the radial wall thickness; and / or, the axial length of any one of the distal electrode 141, intermediate electrode 142, and proximal electrode 143 is greater than or equal to the axial length of any one of the first insulating ring 148 and second insulating ring 149. Specifically, "the axial length of at least one of the distal electrode 141, intermediate electrode 142, proximal electrode 143, first insulating ring 148, and second insulating ring 149 is less than the radial wall thickness" means that among these, at least one (such as the distal electrode 141) may be set to have an axial length less than the radial wall thickness, or two of them may be set in this way, or all of them may be set in this way, but at least one of them must be set to this way. This design not only reduces the axial stiffness of the electrode in the inner tube 12, making it easier for the catheter to pass through curved blood vessels, but also ensures that the electrode wall thickness is relatively high without increasing the folded contour of the balloon 11. This improves the electrode's corrosion resistance, makes the shock wave energy more stable, and prevents the electrode from falling off, thereby increasing the success rate and safety of the surgery.

[0067] In the above description, "the axial length of any one of the distal electrode 141, intermediate electrode 142, and proximal electrode 143 is greater than or equal to the axial length of any one of the first insulating ring 148 and the second insulating ring 149" means that among the three electrodes, at least one has an axial length greater than or equal to the axial length of any one of the first insulating ring 148 and the second insulating ring 149. It could also be two or all three, but at least one of them must be in this configuration. In this embodiment, the axial lengths of the distal electrode 141, intermediate electrode 142, and proximal electrode 143 are set to be equal, and the axial lengths of the first insulating ring 148 and the second insulating ring 149 are also set to be equal. Furthermore, the axial length of the insulating ring is 0.5-0.8 times the axial length of the electrode. This allows for a large and stable energy output from the shockwave balloon catheter 1.

[0068] In some embodiments, such as Figure 1As shown, the inner tube 12, located at both ends of the inner cavity 110, is provided with contrast-enhancing rings 16. The contrast-enhancing rings 16 are made of contrast-enhancing metal wires (such as tantalum, platinum-tungsten alloy, platinum, and platinum-iridium alloy wires), which are forged and installed on the inner tube 12, with the electrode assembly 14 positioned between the two contrast-enhancing rings 16. By setting the contrast-enhancing rings 16, the working length and position of the balloon 11 within the human body can be clearly displayed during the surgical procedure using appropriate detection equipment, ensuring the safety of the surgery. And / or, a guide head 17 is provided at the connection between the distal end of the inner tube 12 and the distal end of the balloon 11. The guide head 17 is a relatively flexible composite hollow tube composed of low-density polyethylene and high-density polyethylene. The guide head 17 is designed to enter the blood vessel first, and its distal end is designed with a pointed tip and rounded chamfers. This not only facilitates entry into the blood vessel but also effectively prevents damage to the blood vessel wall during advancement. And / or, a conduit seat 18 for introducing filling medium into the inner cavity 110 is connected to the proximal end of the outer tube 13, and the output tube of the external pressurization device is connected to the conduit seat 18, so that the filling medium can be introduced into the channel 10.

[0069] In some embodiments, such as Figure 1 As shown, the internal cavity of the inner tube 12 forms a guidewire lumen 120 for the guidewire to pass through, thereby providing guidance and strength support for the advancement of the balloon 11 within the blood vessel. The proximal end of the inner tube 12 is inserted through the middle of the outer tube 13 at a predetermined distance from the proximal end of the outer tube 13, thus providing space for guidewire manipulation.

[0070] In some embodiments, such as Figure 1 As shown, the shockwave balloon catheter 1 also includes a thiopancreatography (THB) tube 19, which is connected between the proximal end of the outer tube 13 and the catheter hub 18. The main purpose of the THB tube 19 is to act as a proximal pusher, providing good force transmission and support so as to accurately push the balloon 11 to the target location to be treated.

[0071] The above description is merely an embodiment of this application and is not intended to limit the scope of protection of this application. Any modifications, equivalent substitutions, and improvements made within the spirit and scope of this application are included within the scope of protection of this application.

Claims

1. A shockwave balloon catheter, characterized in that, include: A balloon with an internal cavity; An inner tube, the distal end of which passes through the inner cavity and is sealed to the distal end of the balloon; An outer tube is sleeved on the inner tube and forms a channel between the outer tube and the inner tube for introducing a filling medium into the inner cavity. The proximal end of the balloon is sealed to the distal end of the outer tube. An electrode assembly is used to generate an electric arc pulse discharge in the filling medium between two electrodes after being energized. The pulse discharge forms a plasma channel and causes the filling medium to expand and explode violently, thereby generating a shock wave. The electrode assembly is connected to the inner tube located in the inner cavity. An insulating layer is provided on the outer surface of the electrode assembly, and a discharge region is formed by removing a portion of the insulating layer on the outer surface of the electrode assembly.

2. The shockwave balloon catheter as described in claim 1, characterized in that, The electrode assembly includes a distal electrode and a proximal electrode, and at least one conductive hole for electrical connection with a power supply wire is provided on the distal electrode and the proximal electrode respectively. The insulating layer and the discharge region are respectively provided on the distal electrode and the proximal electrode. The distal electrode and the proximal electrode are sequentially arranged side by side on the inner tube.

3. The shockwave balloon catheter as described in claim 2, characterized in that, The electrode assembly further includes an intermediate electrode, on which the insulating layer and the discharge region are disposed; The distal electrode, the intermediate electrode, and the proximal electrode are sequentially arranged side by side on the inner tube.

4. The shockwave balloon catheter as described in claim 3, characterized in that, The distal electrode and the proximal electrode are each provided with a discharge region, and the intermediate electrode is provided with two discharge regions, which are distributed at 180°. Wherein, the discharge region on the distal electrode and any one of the discharge regions on the intermediate electrode are both located on the outer peripheral wall and face the same direction; the discharge region on the proximal electrode and the other discharge region on the intermediate electrode are both located on the outer peripheral wall and face the same direction; or, The distal electrode, the intermediate electrode, and the proximal electrode are arranged sequentially at intervals. The discharge region on the distal electrode and any one of the discharge regions on the intermediate electrode are respectively arranged on two sidewalls within the gap and are arranged opposite to each other. The discharge region on the proximal electrode and another discharge region on the intermediate electrode are respectively arranged on two sidewalls within the gap and are arranged opposite to each other.

5. The shockwave balloon catheter as described in claim 3, characterized in that, The discharge regions respectively provided on the distal electrode, the intermediate electrode and the proximal electrode are located at the axial center of the corresponding electrode, or at any edge of the two opposite ends of the axial direction, or connect the two opposite ends of the axial direction.

6. The shockwave balloon catheter as described in claim 1, characterized in that, An installation structure is provided between the inner tube and the electrode assembly, and the installation structure is used to position the electrode assembly connected to the inner tube.

7. The shockwave balloon catheter as described in claim 6, characterized in that, The mounting structure includes: A positioning groove is formed on the outer wall of the inner tube, and the electrode assembly is fitted into the positioning groove.

8. The shockwave balloon catheter as described in claim 7, characterized in that, The mounting structure further includes a guide groove and a positioning block. The guide groove is disposed on either the inner tube or the electrode group, and the positioning block is disposed on the other of the inner tube or the electrode group. The positioning block slides along the guide groove into the positioning groove and abuts against the inner wall of the positioning groove.

9. The shockwave balloon catheter as described in claim 8, characterized in that, The guide groove is disposed on the outer side wall of the inner tube and extends at least along the axial direction of the inner tube to communicate with the positioning groove; the positioning block is disposed on the inner wall of the electrode assembly; wherein, at least two guide grooves and two positioning blocks are respectively symmetrically disposed.

10. The shockwave balloon catheter as described in claim 2 or 3, characterized in that, The electrode assembly comprises at least two sets, all of which are disposed on the inner tube located within the inner cavity and are respectively close to the distal end and proximal end of the balloon. The distal electrode close to the distal end of the balloon is connected to a high-voltage pulse generator via a first wire, the proximal electrode close to the distal end of the balloon is connected to the distal electrode close to the proximal end of the balloon via a second wire, and the proximal electrode close to the proximal end of the balloon is connected to the high-voltage pulse generator via a third wire.

11. The shockwave balloon catheter as described in claim 2 or 3, characterized in that, The electrode assembly also includes an insulating ring, which is sleeved on the inner tube and located between the distal electrode and the proximal electrode.

12. The shockwave balloon catheter as described in claim 3, characterized in that, The electrode assembly further includes a first insulating ring and a second insulating ring. The first insulating ring is sleeved on the inner tube and located between the distal electrode and the intermediate electrode. The second insulating ring is sleeved on the inner tube and located between the intermediate electrode and the proximal electrode.

13. The shockwave balloon catheter as described in claim 12, characterized in that, The axial length of at least one of the distal electrode, the intermediate electrode, the proximal electrode, the first insulating ring, and the second insulating ring is less than the radial wall thickness; and / or, The axial length of any one of the distal electrode, the intermediate electrode, and the proximal electrode is greater than or equal to the axial length of any one of the first insulating ring and the second insulating ring.

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