Shock wave catheter and shock wave equipment

Abstract

The invention discloses a shock wave catheter and shock wave equipment, and relates to the technical field of medical instruments.The shock wave catheter comprises an inner tube and at least one set of electrode assemblies fixedly arranged on the periphery of the inner tube, and all the electrode assemblies are arranged at intervals in the axial direction of the inner tube; each group of electrode assembly comprises an inner-layer electrode, an insulating sleeve and an outer-layer electrode which are sequentially arranged from inside to outside in the radial direction of the inner tube; the inner layer electrode comprises at least two inner electrode plates which are arranged at intervals in the circumferential direction of the inner pipe; the side wall of the insulating sleeve is provided with at least two discharge through holes; along the radial direction of the inner tube, the radial projections of all the discharge through holes fall on all the inner electrode plates in a one-to-one correspondence manner; the outer-layer electrode comprises two outer electrode rings which are arranged at the two ends of the insulating sleeve in a sleeving mode respectively, a discharging protrusion is arranged on the end face of at least one outer electrode ring, the discharging protrusion protrudes and extends in the direction close to the discharging through hole in the axial direction of the inner tube, the discharging mode is upgraded, the operation time is shortened, the shock wave occurrence frequency is reduced, the treatment effect is improved, and the operation time is shortened.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a shock wave catheter and shock wave device. Background Technology

[0002] In the ongoing development of percutaneous coronary intervention, coronary artery calcification remains one of the major challenges in clinical practice. Severe calcification can lead to decreased vascular compliance, often causing complications such as incomplete stent expansion and restenosis. Traditional treatment methods, such as high-pressure balloon angioplasty and rotational atherectomy, are not only complex to perform but also carry a high risk of vascular injury.

[0003] To address these issues, the shockwave balloon catheter was developed. This technology crosses the boundaries of urology, applying the mature principles of extracorporeal shock wave lithotripsy to cardiovascular intervention, resulting in endovascular coronary lithotripsy. Its working principle involves releasing pulses through electrodes within the balloon, utilizing the electrohydraulic effect to generate high-energy shock waves. These shock waves selectively target calcified plaques, causing multiple, micro-fragments through mechanical stress, thereby loosening the calcified tissue, improving vascular compliance and lumen area, and avoiding the damage to the vessel wall caused by traditional high-pressure dilation.

[0004] While shockwave balloon technology offers an innovative solution for coronary artery calcification, its clinical application remains limited by current technological capabilities. When dealing with rigid, severely calcified vessels or vessels with long calcified areas, a single treatment often fails to achieve sufficient vessel release. To achieve the desired luminal effect, operators frequently need to extend the procedure time or increase the number of shockwaves. This not only increases contrast agent usage and radiation exposure but also, due to the prolonged catheter manipulation time within the coronary artery and multiple energy releases, increases the risk of complications such as vascular dissection and perforation, severely impacting both the surgical outcome and procedure time. Summary of the Invention

[0005] In view of this, the purpose of the present invention is to provide a shock wave catheter and shock wave device, which changes the inner electrode to a split layout and adjusts the layout of the discharge through holes and discharge protrusions, while upgrading the discharge mode, effectively shortening the operation time and reducing the number of shock wave occurrences, thereby improving the treatment effect and shortening the operation time. This solves the technical problem that existing shock wave catheters have poor surgical results and long operation time due to their effective calcification and decomposition capabilities.

[0006] To achieve the above objectives, the present invention provides a shock waveguide, comprising an inner tube and at least one set of electrode assemblies fixed to the outer periphery of the inner tube, wherein each electrode assembly is arranged at intervals along the axial direction of the inner tube; each set of electrode assemblies comprises an inner electrode, an insulating sleeve and an outer electrode arranged sequentially from the inside to the outside along the radial direction of the inner tube.

[0007] The inner electrode includes at least two inner electrode plates arranged circumferentially spaced along the inner tube.

[0008] The sidewall of the insulating sleeve is provided with at least two discharge through holes, which are arranged one-to-one on the inner electrode plate and are used to partially expose the inner electrode plate.

[0009] The outer electrode includes two outer electrode rings respectively fitted onto both ends of the insulating sleeve. At least one outer electrode ring has a discharge protrusion on its end face. The discharge protrusion extends along the axial direction of the inner tube to approach the discharge through hole. The discharge through hole is used to form a discharge gap between the discharge protrusion and the opposite inner electrode.

[0010] In some embodiments, the inner electrode sheet includes a first inner electrode sheet, a second inner electrode sheet, and a third inner electrode sheet arranged sequentially along the circumference of the inner tube; the first inner electrode sheet and the third inner electrode sheet are symmetrically arranged on both sides of the second inner electrode sheet along the circumference of the inner tube.

[0011] The insulating sleeve includes a first discharge through hole, a second discharge through hole, a third discharge through hole and a fourth discharge through hole arranged sequentially along the circumference of the inner tube; the first discharge through hole is used to partially expose the first inner electrode plate, the second discharge through hole and the third discharge through hole are used to expose different parts of the second inner electrode plate respectively, and the fourth discharge through hole is used to partially expose the third inner electrode plate.

[0012] In some embodiments, the second and third discharge through holes are axially offset, the first and second discharge through holes are located on the same circumferential trajectory perpendicular to the axis, and the third and fourth discharge through holes are located on another circumferential trajectory perpendicular to the axis. The central angle of the first and second discharge through holes is α, the central angle of the third and fourth discharge through holes is b, and the central angle of the second and third discharge through holes is c. Wherein, α, b, and c satisfy: α is equal to b, (α+c) is equal to (b+c) and is not less than 120°, and cb≥2α.

[0013] In some embodiments, the outer electrode ring includes a first outer electrode and a second outer electrode. The first outer electrode is provided with a first discharge protrusion, and the second outer electrode is provided with a second discharge protrusion. The first discharge protrusion and the second discharge protrusion are staggered along the circumference of the inner tube.

[0014] Along the axial direction of the inner tube, the first discharge protrusion extends along the axial direction of the inner tube to approach the first discharge through hole and the second discharge through hole; the second discharge protrusion extends along the axial direction of the inner tube to approach the third discharge through hole and the fourth discharge through hole.

[0015] The first, second, third, and fourth discharge holes are evenly distributed in the projection along the axial direction of the inner tube.

[0016] In some embodiments, the outer electrode ring includes a first outer electrode and a second outer electrode. The first outer electrode is provided with a first discharge protrusion, and the second outer electrode is provided with a second discharge protrusion. The first discharge protrusion and the second discharge protrusion are 180° apart along the circumference of the inner tube.

[0017] Along the axial direction of the inner tube, the first discharge through hole and the second discharge through hole are respectively opposite to the first discharge protrusion; the third discharge through hole and the fourth discharge through hole are respectively opposite to the second discharge protrusion.

[0018] In some embodiments, the sidewall of the insulating sleeve is provided with an installation slit that extends axially through the inner tube; the installation slit is offset from the inner electrode along the circumference of the inner tube, and the installation slit is offset from the discharge protrusion along the circumference of the inner tube.

[0019] In some embodiments, an insulating spacer is provided between two adjacent inner electrode plates along the circumference of the inner tube.

[0020] In some embodiments, along the axial direction of the inner tube, the length of the insulating sleeve is greater than the length of the inner electrode, and both ends of the insulating sleeve extend beyond the inner electrode. The space between the extended portions of the insulating sleeve and the inner tube is filled with a sealant layer. Two outer electrode rings are respectively fitted onto the extended portions of the insulating sleeve at both ends.

[0021] In some embodiments, any two adjacent sets of electrode assemblies are electrically connected by wires; an annular gap is formed between the outer electrode and the inner tube, and the wires are arranged in the annular gap.

[0022] The present invention also provides a shock wave device, including a pulse generator, a connector and the aforementioned shock wave conduit, wherein the connector is connected between the pulse generator and the shock wave conduit.

[0023] Compared to the prior art, this invention provides a systematically optimized design for the electrode assembly of the shock waveguide. Specifically, the inner electrode is changed from a single integrated structure to at least two inner electrode plates spaced apart along the circumference of the inner tube, forming a split layout. This lays the foundation for achieving multiple independent discharge regions on the same cross-section. Based on this, the number of discharge vias on the insulating sleeve is increased accordingly, and their spatial distribution is redesigned to ensure that the radial projection of all discharge vias falls on the surface of the inner electrode plates. Simultaneously, the layout of the discharge protrusions on the end face of the outer electrode ring is adjusted to form a series circuit with twice the number of discharge points compared to the traditional electrode structure.

[0024] This series of improvements, by constructing a series circuit with double the discharge points and simultaneously upgrading the discharge mode, enhances the acoustic pressure intensity of a single electrode assembly and increases the acoustic pressure range of the electrode assembly by superimposing the sound pressure of the shock waves generated by multiple discharge points. This enables the shock wave catheter to obtain stronger calcification lysis capabilities, effectively addressing complex lesions such as severe calcification or long segmental calcification. Consequently, it helps to shorten operation time, reduce the number of shock wave occurrences, lower operation-related risks, effectively improve treatment outcomes, and shorten operation time. Attached Figure Description

[0025] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the provided drawings without creative effort.

[0026] Figure 1 This is a schematic diagram of the shock waveguide provided by the present invention;

[0027] Figure 2 This is a schematic diagram of a shock waveguide provided in some embodiments of the present invention;

[0028] Figure 3 for Figure 2 Schematic diagram of the middle electrode assembly;

[0029] Figure 4 for Figure 3 Assembly diagram of the inner tube, inner electrode, and insulating sleeve;

[0030] Figure 5 for Figure 3 Assembly diagram of the inner tube and inner electrode layer;

[0031] Figure 6 for Figure 3 Exploded view;

[0032] Figure 7 for Figure 3 Schematic diagram of the insulating sleeve;

[0033] Figure 8 for Figure 3 Schematic diagram of the inner and outer electrode rings;

[0034] Figure 9 This is a schematic diagram of the acoustic pressure range of the electrode assembly of the shock wave duct provided in some embodiments of the present invention;

[0035] Figure 10 This is a schematic diagram of the electrode assembly of the shock waveguide provided in some embodiments of the present invention;

[0036] Figure 11 for Figure 10 Exploded view;

[0037] Figure 12 for Figure 10 Schematic diagram of the insulating sleeve;

[0038] Figure 13 This is a schematic diagram showing the sound pressure range of the electrode assembly of the shock wave duct provided in some embodiments of the present invention.

[0039] The attached figures are labeled as follows:

[0040] Inner tube 1, electrode assembly 2, outer tube 3, balloon 4, wire 5, pulse generator 6, and connector 7;

[0041] Inner electrode 21, insulating sleeve 22 and outer electrode 23;

[0042] First inner electrode plate 211, second inner electrode plate 212, third inner electrode plate 213;

[0043] First discharge through hole 221, second discharge through hole 222, third discharge through hole 223 and fourth discharge through hole 224, and mounting slit 225;

[0044] First external electrode 231 and second external electrode 232;

[0045] First discharge protrusion 2311;

[0046] Second discharge protrusion 2321. Detailed Implementation

[0047] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0048] To enable those skilled in the art to better understand the present invention, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0049] This invention discloses a shock wave duct, as shown in the attached figure. Figure 1 and 2 As shown, it includes an inner tube 1 and at least one set of electrode assemblies 2 fixed to the outer periphery of the inner tube 1. Each electrode assembly 2 is arranged at intervals along the axial direction of the inner tube 1, so that a single treatment can cover a longer diseased blood vessel.

[0050] It should be noted that, as shown in the attached document Figure 1As shown, the shockwave catheter also includes an outer tube 3 and a balloon 4 axially connected to the outer tube 3. An inner tube 1 passes sequentially through the outer tube 3 and the balloon 4. The end of the balloon 4 furthest from the outer tube 3 is tightly fitted to the inner tube 1, forming a semi-closed structure with only a proximal exchange port to the outside environment. This ensures that the balloon 4 forms a stable liquid conductive medium environment after inflation. All electrode components 2 are located inside the balloon 4, and the generated pulsed mechanical energy is efficiently transmitted to the calcified area of ​​the blood vessel through the medium.

[0051] As attached Figures 2 to 6 As shown, each electrode assembly 2 includes an inner electrode 21, an insulating sleeve 22, and an outer electrode 23 arranged sequentially from the inside to the outside along the radial direction of the inner tube 1. The insulating sleeve 22 serves as an insulating barrier between the inner electrode 21 and the outer electrode 23, and guides and constrains the discharge path through the discharge through hole to prevent short circuits between the inner and outer electrodes.

[0052] As attached Figure 4 and 5 As shown, the inner electrode 21 includes at least two inner electrode plates arranged circumferentially along the inner tube 1. Each inner electrode plate forms an independent discharge path with the outer electrode 23 through a corresponding discharge through-hole. The sidewall of the insulating sleeve 22 is provided with at least two discharge through-holes. Each discharge channel can constrain and concentrate the current to achieve directional impact. The discharge through-holes are arranged one-to-one on the inner electrode plates and are used to partially expose the inner electrode plates.

[0053] Along the radial direction of the inner tube 1, the radial projection of all the discharge through holes corresponds to all the inner electrode plates, ensuring that the current emitted by each inner electrode plate has the shortest discharge path and the lowest impedance when passing through the discharge through hole and the corresponding outer electrode 23, minimizing the energy loss of the current during transmission, so that most of the electrical energy can be efficiently used to generate plasma at the discharge through hole, thereby converting it into impact mechanical energy.

[0054] As attached Figure 2 and 3 As shown, the outer electrode 23 includes two outer electrode rings respectively sleeved on both ends of the insulating sleeve 22. At least one outer electrode ring has a discharge protrusion on its end face. The discharge protrusion extends along the axial direction of the inner tube 1 to approach the discharge through hole. The discharge through hole is used to form a discharge gap between the discharge protrusion and the opposite inner electrode, thereby establishing a concentrated electric field in the axial direction of the inner tube 1 and converting it into a stronger shock wave.

[0055] When a momentary high-voltage pulse is applied between the inner electrode 21 and the outer electrode 23, the liquid medium at the discharge hole on the insulating sleeve 22 is ionized to form plasma. The rapid expansion of the plasma will generate a high-speed shock wave in the local liquid. The shock wave passes through the liquid medium inside the balloon 4 and is evenly transmitted to the calcified area of ​​the blood vessel from the center of the balloon 4, causing cracks in the hard calcified plate.

[0056] This invention provides a systematic optimization design for the electrode assembly 2 of the shock waveguide. Specifically, the inner electrode 21 is changed from a single integrated structure to at least two inner electrode plates spaced apart circumferentially along the inner tube 1, forming a split layout. This lays the foundation for achieving multiple independent discharge regions on the same cross-section. Based on this, the number of discharge vias on the insulating sleeve 22 is increased accordingly, and their spatial distribution is redesigned to ensure that the radial projection of all discharge vias falls on the surface of each inner electrode plate. Simultaneously, the layout of the discharge protrusions on the end face of the outer electrode ring is adjusted to form a series circuit with twice the number of discharge points compared to the traditional electrode structure.

[0057] In summary, the series of improvements in this invention, by constructing a series circuit with double the discharge points and simultaneously upgrading the discharge mode, enhance the sound pressure intensity of a single electrode assembly 2 and increase the sound pressure range of the electrode assembly by superimposing the sound pressure of the shock waves generated by multiple discharge points. This enables the shock wave catheter to obtain stronger calcification lysis capabilities, effectively addressing complex lesions such as severe calcification or long segmental calcification. Consequently, it helps to shorten operation time, reduce the number of shock wave occurrences, lower operation-related risks, and effectively improve surgical safety.

[0058] In some embodiments, as shown in the appendix Figures 4 to 6 As shown, electrode assembly 2 adopts an asymmetric design. By precisely controlling the generation point and propagation direction of the shock wave, it can actively focus energy on a specific target area. It can concentrate the peak sound pressure of the shock wave onto hard, severely calcified lesions, improving their fragmentation efficiency and depth, thereby enhancing surgical safety.

[0059] In some embodiments, as shown in the appendix Figure 4 and 5 As shown, the inner electrode 21 adopts an asymmetrical tripolar layout, which is suitable for complex lesions with non-uniform distribution. Specifically, the inner electrode includes a first inner electrode 211, a second inner electrode 212, and a third inner electrode 213 arranged sequentially along the circumference of the inner tube 1. Along the circumference of the inner tube 1, the first inner electrode 211 and the third inner electrode 213 are symmetrically arranged on both sides of the second inner electrode 212.

[0060] In some embodiments, as shown in the appendix Figure 4 , 6As shown in Figure 7, the insulating sleeve 22 has four discharge through holes arranged in pairs close to each other. The shock waves generated by two adjacent discharge points will rapidly superimpose due to their close proximity, creating two high-energy focusing zones inside the balloon 4. This results in strong calcification-breaking capabilities, making it suitable for severely calcified blood vessels. Specifically, the discharge through holes include a first discharge through hole 221, a second discharge through hole 222, a third discharge through hole 223, and a fourth discharge through hole 224 arranged sequentially along the circumference of the inner tube 1. All four are circular through holes. The first discharge through hole 221 is used to partially expose the first inner electrode 211, the second discharge through holes 222 and the third discharge through hole 223 are used to expose different parts of the second inner electrode 212, and the fourth discharge through hole 224 is used to partially expose the third inner electrode 213.

[0061] In some embodiments, along the radial direction of the inner tube 1, the radial projection of the first discharge through-hole 221 falls on the first inner electrode plate 211, the radial projections of the second discharge through-hole 222 and the third discharge through-hole 223 fall on the two ends of the second inner electrode plate 212 respectively, and the radial projection of the fourth discharge through-hole 224 falls on the third inner electrode plate 213; that is, the second inner electrode plate 212 simultaneously connects to two discharge through-holes, while the first inner electrode plate 211 and the third inner electrode plate 213 each connect to only one discharge through-hole, ensuring that the current path between each discharge through-hole and the corresponding inner electrode plate is minimized, thereby minimizing energy loss in line transmission and reducing the risk of short circuits due to misalignment. In other words, the present invention can precisely control four discharge through-holes using only three inner electrode plates, achieving the driving of the most discharge points with the fewest inner electrode plates, and improving energy coverage density without excessively increasing electrical complexity.

[0062] In some embodiments, along the circumference of the inner tube 1, the first inner electrode 211 and the third inner electrode 213 are symmetrically arranged on both sides of the second inner electrode 212, so that the inner electrode 21 forms a ring-shaped impact structure, which improves the efficiency of lithotripsy and ensures the uniformity and safety of the operation.

[0063] In some embodiments, as shown in the appendix Figure 2 , 3 As shown in Figure 6, the outer electrode ring includes a first outer electrode 231 and a second outer electrode 232. The first outer electrode 231 is provided with a first discharge protrusion 2311, and the second outer electrode 232 is provided with a second discharge protrusion 2321. The first discharge protrusion 2311 and the second discharge protrusion 2321 are staggered along the circumference of the inner tube 1, so as to establish two spatially separated energy emission sources in the balloon 4, effectively avoiding the energy dead zone that may exist in a single-point emission source, and ensuring complete coverage of long segment or angular lesions.

[0064] Along the axial direction of the inner tube 1, the first discharge protrusion 221 extends along the axial direction of the inner tube 1 to approach the first discharge through hole 221 and the second discharge through hole 222; the second discharge protrusion 222 extends along the axial direction of the inner tube 1 to approach the third discharge through hole 223 and the fourth discharge through hole 224; the first discharge through hole 221, the second discharge through hole 222, the third discharge through hole 223 and the fourth discharge through hole 224 are uniformly distributed in the projection along the axial direction of the inner tube 1.

[0065] In some embodiments, along the axial direction of the inner tube 1, the first discharge through hole 221 and the second discharge through hole 222 are respectively opposite to the first discharge protrusion 2311, and the third discharge through hole 223 and the fourth discharge through hole 224 are respectively opposite to the second discharge protrusion 2321, so that the number of discharge points is upgraded to eight, the discharge coverage is expanded, and it can act more comprehensively on the lesion area, thereby improving the efficiency of lithotripsy.

[0066] In some embodiments, as shown in the appendix Figure 5 As shown, the three inner electrode plates adopt a symmetrical design with a longer middle section and shorter ends. Specifically, the first inner electrode plate 211, the second inner electrode plate 212, and the third inner electrode plate 213 are all arc-shaped electrodes. The arc lengths of the first inner electrode plate 211 and the third inner electrode plate 213 are equal, ensuring that the electrical characteristics on both sides of the second inner electrode plate 212 are completely symmetrical. This avoids distortion of the shock wave field due to inconsistent electrode sizes, thereby preventing current bias to one side, reducing unnecessary vibration or torque, and effectively improving the working stability of the shock waveguide. Furthermore, the arc lengths of the first inner electrode plate 211 and the third inner electrode plate 213 are both smaller than the arc length of the second inner electrode plate 212. By extending the arc length of the second inner electrode plate 212, its discharge area is increased, allowing the second inner electrode plate 212 to better cover the core lesion area and provide sufficient energy to effectively decompose the heavily calcified area.

[0067] In some embodiments, as shown in the appendix Figure 4 and 7As shown, along the circumference of the inner tube 1, the first discharge through-hole 221 and the fourth discharge through-hole 224 are symmetrically arranged on both sides of the insulating sleeve 22, and the second discharge through-hole 222 and the third discharge through-hole 223 are symmetrically arranged on both sides of the insulating sleeve 22. Further, along the circumference of the inner tube 1, the arc length between the first discharge through-hole 221 and the second discharge through-hole 222, and the arc length between the third discharge through-hole 223 and the fourth discharge through-hole 224 are both smaller than the arc length between the second discharge through-hole 222 and the third discharge through-hole 223. By grouping the four discharge through-holes into pairs with a small circumferential distance, and setting a larger distance between the two groups, the four discharge through-holes are arranged close to each other, thus constructing two high-energy focusing zones within the balloon 4. Within each group, the shock waves generated between two adjacent discharge through-holes rapidly superimpose to generate a strong local sound pressure, while the larger distance between the two groups ensures that the two highly focused zones cover a wider impact range.

[0068] In one embodiment, the pulse generator 6 generates current, which passes through the first inner electrode 211, through the first discharge through-hole 221, and reaches the first discharge protrusion 2311 of the first outer electrode 231, forming a first discharge point at the first discharge through-hole 221. The current on the first discharge protrusion 2311 of the first outer electrode 231 passes through the second discharge through-hole 222 and reaches the second inner electrode 212, forming a second discharge point at the second discharge through-hole 222. The current on the second inner electrode 212 passes through the third discharge through-hole 223 and reaches the second discharge protrusion 2321 of the second outer electrode 232, forming a third discharge point at the third discharge through-hole 223. The current on the second discharge protrusion 2321 of the second outer electrode 232 passes through the fourth discharge through-hole 224 and reaches the third inner electrode 213, forming a fourth discharge point at the fourth discharge through-hole 224. The above describes the discharge points and current flow of one set of electrode components. The current is conducted through the wire 5 to another electrode component and finally returns to the pulse generator 6, thus forming a complete series circuit.

[0069] In some embodiments, such as Figure 4 , 7As shown, the second discharge through hole 222 and the third discharge through hole 223 are offset along the axial direction of the inner tube 1. The first discharge through hole 221 and the second discharge through hole 222 are located on the same circumferential trajectory perpendicular to the axis of the inner tube 1. The third discharge through hole 223 and the fourth discharge through hole 224 are located on another circumferential trajectory perpendicular to the axis of the inner tube 1. The central angle between the first discharge through hole 221 and the second discharge through hole 222 is α, and the central angle between the third discharge through hole 223 and the fourth discharge through hole 224 is b. The central angle c of the through hole 223 (since the second discharge through hole 222 and the third discharge through hole 223 are not arranged in the same row, the central angle here is calculated by projecting the centers of the two holes onto the same radial section and then using the axis center as the vertex. This angle is the central angle c at this location), where a, b, and c satisfy: a and b are approximately equal, (a+c) is approximately equal to (b+c) and both are not less than 120°, cb≥2a, for example, a and b are both 30° and c is 90°, or a and b are both 25° and c is 155°. Therefore, the first discharge through hole 221, the second discharge through hole 222, the third discharge through hole 223, and the fourth discharge through hole 224 are not circumferentially uniformly distributed, but form two concentrated discharge regions with their discharge positions close to each other on an electrode assembly 2, such as Figure 9 As shown, when the spacing between any two of the four discharge points approaches a certain value, the sound pressure intensity of the superimposed discharge region is significantly increased compared to conventional designs due to the superposition characteristics of shock waves. This significantly enhances the calcification dissolution capability and reduces the number of shock wave treatments required. Another set of discharge components can combine its superimposed discharge region with... Figure 9 The areas shown are staggered; for example, the discharge points are designed to be evenly distributed circumferentially along the axial projection. This ensures uniform disintegration of circumferentially calcified lesions, thereby shortening the overall operation time and reducing surgical risks. This electrode structure not only targets severely calcified lesions but also reduces the number of shock waves due to improved lithotripsy capabilities. Even in long diseased vessels, multiple catheter replacements are unnecessary, saving surgical costs and enhancing surgical safety. Furthermore, this structure can achieve calcification disintegration effects comparable to similar products at lower input voltages, significantly reducing electrode erosion and extending catheter lifespan.

[0070] In some embodiments, as shown in the appendix Figure 11 As shown, the inner electrode plates include a first inner electrode plate 211, a second inner electrode plate 212, and a third inner electrode plate 213 arranged sequentially along the circumference of the inner tube 1. Crucially, the four discharge through holes of the insulating sleeve 22 are circumferentially evenly spaced. Specifically, as shown in the attached diagram... Figure 12As shown, the discharge through-holes include a first discharge through-hole 221, a second discharge through-hole 222, a third discharge through-hole 223, and a fourth discharge through-hole 224, which are all circular through-holes, arranged at equal intervals along the circumference of the inner tube 1. The four discharge through-holes are distributed at equal intervals to achieve uniform energy output throughout the 360° circumference, which uniformly impacts the circumference of the blood vessel wall. This ensures that the shock wave energy acts simultaneously and indiscriminately on the entire circumference of the blood vessel wall, effectively avoiding the problem of incomplete calcification and lysis or the existence of treatment dead zones caused by uneven energy distribution.

[0071] Along the radial direction of the inner tube 1, the radial projection of the first discharge through hole 221 falls on the first inner electrode plate 211, the radial projections of the second discharge through hole 222 and the third discharge through hole 223 both fall on the second inner electrode plate 212, and the radial projection of the fourth discharge through hole 224 falls on the third inner electrode plate 213, ensuring that the energy source intensity of each discharge point is equal, avoiding local hot spots caused by energy source asymmetry, and making the treatment effect stable and reliable.

[0072] In some embodiments, as shown in the appendix Figure 10 and 11 As shown, the outer electrode ring includes a first outer electrode 231 and a second outer electrode 232. The first outer electrode 231 has a first discharge protrusion 2311, and the second outer electrode 232 has a second discharge protrusion 2321. The first discharge protrusion 2311 and the second discharge protrusion 2321 are 180° apart along the circumference of the inner tube 1, forming a completely symmetrical layout. This ensures that during pulse discharge, when the current passes through multiple series-connected discharge points, the sound pressure between the two sets of outer electrodes is uniform. The discharge forces induced by the first discharge protrusion 2311 and the second discharge protrusion 2321 are balanced in the circumferential space, and the shock wave or sound pressure generated by the discharge can radiate more uniformly around the inner tube. Figure 13 As shown, this avoids localized energy concentration or attenuation caused by discharge point misalignment, thereby improving the stability of the entire discharge process and facilitating more efficient pulse discharge operation. It also ensures uniform acoustic pressure between the two electrode sets during pulse discharge.

[0073] Furthermore, along the axial direction of the inner tube 1, the first discharge through hole 221 and the second discharge through hole 222 are respectively opposite to the first discharge protrusion 2311, and the third discharge through hole 223 and the fourth discharge through hole 224 are respectively opposite to the second discharge protrusion 2321. The four discharge through holes are aligned to form two independent discharge gaps, which can simultaneously excite two discharge points and help reduce power consumption.

[0074] When the first discharge protrusion 2311 discharges through the first and second through holes, it forms an action area inside the balloon 4; when the second discharge protrusion 2321 discharges through the third and fourth through holes, it forms another action area. The two action areas are misaligned in the axial direction. After the two areas are superimposed, they jointly construct a treatment field that is wider in the axial direction and more uniform in the circumferential direction inside the balloon 4, effectively ensuring that the calcification of long blood vessels can be uniformly covered.

[0075] In some embodiments, as shown in the appendix Figure 7 and 12 As shown, the insulating sleeve 22 has an axially extending mounting slit 225 on its side wall, providing a wiring channel for the wires 5 connected between the two sets of electrode assemblies 2, preventing the wires 5 from passing through the outer surface of the outer electrode 23 and obstructing the smooth passage of the inner tube 1. The mounting slit 225 is offset from the inner electrode 21 along the circumference of the inner tube 1, and the mounting slit 225 is also offset from the discharge protrusion along the circumference of the inner tube 1. This ensures that the insulating sleeve 22 provides effective insulation and isolation in the working area of ​​the discharge through-hole and the discharge gap, preventing local electric field distortion caused by the presence of the mounting slit 225, ensuring that the high-voltage pulse is strictly confined within the discharge through-hole, and effectively preventing short circuits between electrodes.

[0076] In a preferred embodiment, an insulating layer is provided between two adjacent inner electrode plates along the circumference of the inner tube 1. This effectively blocks the conductive path between adjacent inner electrode plates, achieving electrical isolation between them, preventing current interference between adjacent inner electrode plates, and ensuring that high-voltage pulses can only be released through the discharge through-hole, thereby improving the operational reliability of the shock waveguide. Specifically, the insulating layer can be an insulating material such as an adhesive layer or plastic sheet adhered to the outer circumference of the inner tube 1, but is not limited to these.

[0077] As a preferred embodiment, as shown in the appendix Figure 3 As shown, along the axial direction of the inner tube 1, the length of the insulating sleeve 22 is greater than the length of the inner electrode 21. Both ends of the insulating sleeve 22 extend beyond the inner electrode 21, and a sealant layer is filled between the extended portions of the insulating sleeve 22 and the inner tube 1, achieving a seamless seal between the insulating sleeve 22 and the inner tube 1. This prevents the liquid medium inside the balloon 4 from seeping into the inner electrode 21 under pressure, fundamentally avoiding short circuits caused by liquid medium intrusion and improving the operational reliability of the shock waveguide. Two outer electrode rings are respectively fitted onto the extended portions at both ends of the insulating sleeve 22, keeping the outer electrode rings away from the intense discharge working area in the middle, improving the mechanical stability of the outer electrode rings, and avoiding positioning inaccuracies or electric field interference problems caused by installation in the discharge through-hole or inner electrode plate.

[0078] As a preferred embodiment, as shown in the appendix Figure 2As shown, any two adjacent sets of electrode assemblies 2 are electrically connected via wires 5, allowing all motor assemblies to be driven with only a single power input, effectively improving structural compactness and ease of operation. An annular gap is formed between the outer electrode 23 and the inner tube 1, and the wires 5 are laid within the annular gap, eliminating the need for a separate channel. This avoids increasing the outer diameter of the shock waveguide due to wiring and prevents the wires 5 from being directly impacted by the fluid flow inside the balloon 4, minimizing the risk of short circuits or breakage of the wires 5 and ensuring the reliability of the electrical connection.

[0079] The present invention also provides a shock wave device, as shown in the attached figure. Figure 1 As shown, it includes a pulse generator 6, a connector 7 and the aforementioned shock wave duct. The connector 7 connects the pulse generator 6 and the shock wave duct. The high-voltage pulse generated by the pulse generator 6 is efficiently transmitted to the electrode assembly 2 inside the shock wave duct through the connector 7, achieving the same beneficial effect.

[0080] It should be noted that in this specification, relational terms such as first and second are used only to distinguish one entity from several other entities, and do not necessarily require or imply any such actual relationship or order between these entities.

[0081] This article uses specific examples to illustrate the principles and implementation methods of the present invention. The descriptions of the above embodiments are only for the purpose of helping to understand the method and core ideas of the present invention. It should be noted that those skilled in the art can make several improvements and modifications to the present invention without departing from the principles of the present invention, and these improvements and modifications also fall within the protection scope of the claims of the present invention.

Claims

1. A shock wave duct, characterized in that, It includes an inner tube and at least one set of electrode assemblies fixed to the outer periphery of the inner tube, with each electrode assembly arranged at intervals along the axial direction of the inner tube; each set of electrode assemblies includes an inner electrode, an insulating sleeve, and an outer electrode arranged sequentially from the inside to the outside along the radial direction of the inner tube. The inner electrode includes at least two inner electrode plates arranged circumferentially spaced along the inner tube. The sidewall of the insulating sleeve is provided with at least two discharge through holes, which are arranged one-to-one on the inner electrode sheet and are used to partially expose the inner electrode sheet; The outer electrode includes two outer electrode rings respectively sleeved on both ends of the insulating sleeve. At least one of the outer electrode rings has a discharge protrusion on its end face. The discharge protrusion extends along the axial direction of the inner tube to approach the discharge through hole. The discharge through hole is used to form a discharge gap between the discharge protrusion and the opposite inner electrode.

2. The shock wave duct according to claim 1, characterized in that, The inner electrode sheet includes a first inner electrode sheet, a second inner electrode sheet, and a third inner electrode sheet arranged sequentially along the circumference of the inner tube; along the circumference of the inner tube, the first inner electrode sheet and the third inner electrode sheet are respectively symmetrically arranged on both sides of the second inner electrode sheet; The insulating sleeve includes a first discharge through hole, a second discharge through hole, a third discharge through hole, and a fourth discharge through hole arranged sequentially along the circumference of the inner tube; the first discharge through hole is used to partially expose the first inner electrode, the second discharge through hole and the third discharge through hole are used to expose different parts of the second inner electrode, and the fourth discharge through hole is used to partially expose the third inner electrode.

3. The shock wave duct according to claim 2, characterized in that, The second and third discharge through holes are axially offset. The first and second discharge through holes are located on the same circumferential trajectory perpendicular to the axis. The third and fourth discharge through holes are located on another circumferential trajectory perpendicular to the axis. The central angle between the first and second discharge through holes is α, the central angle between the third and fourth discharge through holes is b, and the central angle between the second and third discharge through holes is c. α, b, and c satisfy the following conditions: α is equal to b, (a+c) equals (b+c) and is not less than 120°, and cb ≥ 2α.

4. The shock wave duct according to claim 2, characterized in that, The outer electrode ring includes a first outer electrode and a second outer electrode. The first outer electrode is provided with a first discharge protrusion, and the second outer electrode is provided with a second discharge protrusion. The first discharge protrusion and the second discharge protrusion are staggered along the circumference of the inner tube. Along the axial direction of the inner tube, the first discharge protrusion extends along the axial direction of the inner tube to approach the first discharge through hole and the second discharge through hole; the second discharge protrusion extends along the axial direction of the inner tube to approach the third discharge through hole and the fourth discharge through hole. The first discharge through hole, the second discharge through hole, the third discharge through hole, and the fourth discharge through hole are uniformly distributed in the projection along the axial direction of the inner tube.

5. The shock wave duct according to claim 4, characterized in that, The outer electrode ring includes a first outer electrode and a second outer electrode. The first outer electrode is provided with a first discharge protrusion, and the second outer electrode is provided with a second discharge protrusion. The first discharge protrusion and the second discharge protrusion are 180° apart along the circumference of the inner tube. Along the axial direction of the inner tube, the first discharge through hole and the second discharge through hole are respectively opposite to the first discharge protrusion; the third discharge through hole and the fourth discharge through hole are respectively opposite to the second discharge protrusion.

6. The shock waveguide according to any one of claims 1 to 5, characterized in that, The insulating sleeve sidewall is provided with an installation slit that extends axially along the inner tube; the installation slit and the inner electrode are offset circumferentially along the inner tube, and the installation slit and the discharge protrusion are also offset circumferentially along the inner tube.

7. The shock waveguide according to any one of claims 1 to 5, characterized in that, An insulating layer is provided between two adjacent inner electrode plates along the circumference of the inner tube.

8. The shock waveguide according to any one of claims 1 to 5, characterized in that, Along the axial direction of the inner tube, the length of the insulating sleeve is greater than the length of the inner electrode. Both ends of the insulating sleeve extend beyond the inner electrode, and a sealant layer is filled between the extended portions of the insulating sleeve and the inner tube. The two outer electrode rings are respectively fitted onto the extended portions of the insulating sleeve at both ends.

9. The shock waveguide according to any one of claims 1 to 5, characterized in that, Any two adjacent sets of the electrode assemblies are electrically connected by a wire; an annular gap is formed between the outer electrode and the inner tube, and the wire is laid in the annular gap.

10. A shock wave device, characterized in that, It includes a pulse generator, a connector, and a shock wave duct as described in any one of claims 1 to 9, wherein the connector is connected between the pulse generator and the shock wave duct.

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