Shock wave balloon catheter and catheter system

Abstract

A shock wave balloon catheter and a catheter system. The catheter system comprises a pulse generator and a shock wave balloon catheter. The shock wave balloon catheter comprises a catheter shaft (1) and a balloon (2). The balloon (2) is arranged on the catheter shaft (1). The shock wave balloon catheter further comprises an electrode assembly (3) and a reflection assembly (4). The electrode assembly (3) is arranged on the catheter shaft (1). The electrode assembly (3) is used for releasing pulses, such that shock waves can be generated in the balloon (2). The reflection assembly (4) is arranged on the balloon (2) and is used for reflecting the shock waves towards the electrode assembly (3). The shock wave balloon catheter can enhance the crushing capacity of the target tissue, thereby shortening the surgical time, and achieving targeted therapy of the target tissue.

Description

Shock wave balloon catheters and catheter systems Technical Field

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

[0002] With the continuous development of percutaneous coronary intervention (PCI), the lesions involved are becoming more and more numerous and complex. Among them, coronary artery calcification lesions have always been the difficulty and risk of interventional treatment, especially for severe calcification lesions, or complex calcification lesions accompanied by distortion, angulation, and diffusion. In order to effectively treat calcification lesions, correct identification and evaluation of calcification lesions before surgery, and selection of appropriate interventional treatment techniques are the key to improving the success rate of surgery, reducing surgery-related complications, and improving patients' short-term and long-term prognosis. Because the existing high-pressure balloons commonly used to treat calcification lesions can easily cause pneumatic damage to the blood vessels after acting on the vascular endothelium, it may cause tearing of the vascular endothelium, or lead to thrombosis and restenosis in the blood vessels.

[0003] To address these issues, a shock wave balloon catheter has been developed. This catheter utilizes the electrohydraulic effect to destroy fibrotic or calcified plaques within blood vessels. Arc discharge is performed via opposing electrodes, creating a short-duration (<10ms) high-voltage pulse within the vessel. This pulse then generates a high-energy acoustic wave (i.e., a shock wave) with strong acoustic pressure. This high-energy acoustic wave propagates to the calcified plaque within the vessel. Similar to the fracture of any fragile object, the stress generated by the shock wave causes the calcified plaque to begin to crack. Simultaneously, under the repeated action of the shock wave, the calcified cracks further disintegrate and shatter, allowing the broken calcified lesions to expand at low pressure, thus avoiding the problem of sudden, large-scale expansion of the vessel under the high pressure of the balloon during traditional angioplasty, which can cause damage to the vessel wall.

[0004] However, this method often requires more pulses and higher pulse energy when treating eccentric calcification and local calcified nodules, resulting in longer treatment time and poor treatment effect.

[0005] Summary of the Invention

[0006] The object of the present invention is to provide a shock wave balloon catheter and a catheter system, which can enhance the fragmentation ability of target tissue, reduce operation time, and achieve targeted treatment of target tissue.

[0007] To achieve the above-mentioned objectives, the present invention provides a shock wave balloon catheter, comprising a catheter shaft and a balloon, wherein the balloon is arranged at the distal end of the catheter shaft; the shock wave balloon catheter also includes an electrode assembly and a reflection assembly; the electrode assembly is arranged on the catheter shaft, and is used to release pulses, thereby generating shock waves in the balloon; the reflection assembly is arranged on the balloon and is used to reflect the shock waves toward the direction of the electrode assembly.

[0008] Optionally, the reflective component is disposed outside the balloon and fixedly connected to the outer surface of the balloon.

[0009] Optionally, the reflective component is an arc-shaped structure, the inner concave surface of the reflective component faces the electrode assembly, the reflective component is used to reflect shock waves toward the target tissue, and the geometric center of the reflective component can be located at the target tissue.

[0010] Optionally, on the cross-section of the catheter shaft, the position where the reflective component is connected to the balloon is defined as a fixed position, the tangent of the balloon at the fixed position is defined as a first straight line, and the straight line passing through the geometric center of the balloon and perpendicular to the first straight line is defined as a second straight line; the reflective component is symmetrically arranged about the second straight line.

[0011] Optionally, in a cross section of the catheter shaft, the electrode assembly is symmetrically arranged about the second straight line.

[0012] Optionally, the acoustic impedance of the reflective component is greater than the acoustic impedance of the medium filled in the balloon.

[0013] Optionally, the shock wave balloon catheter has at least one of the following structures:

[0014] The length of the reflective component in the axial direction of the catheter shaft is 5 mm to 120 mm;

[0015] The arc length of the reflective component on the cross section perpendicular to the axial direction of the catheter axis is 0.5 mm to 20 mm;

[0016] The diameter of the balloon after inflation is 1 mm to 10 mm;

[0017] The length of the balloon in the axial direction of the catheter shaft is 6 mm to 150 mm.

[0018] Optionally, the number of the electrode assemblies is at least one group, each group of the electrode assemblies includes an inner electrode and an outer electrode, the inner electrode and the outer electrode are arranged opposite to each other, and the inner electrode and the outer electrode interact with each other to generate pulses.

[0019] Optionally, the cross sections of the inner electrode and the outer electrode are both arc-shaped; the inner electrodes and the outer electrodes in each group of the electrode assemblies are arranged at intervals in the circumferential direction of the catheter shaft.

[0020] Optionally, the electrode assemblies are provided in multiple groups, and all groups of the electrode assemblies are arranged at intervals along the axial direction of the catheter axis.

[0021] To achieve the above object, the present invention further provides a catheter system, comprising a pulse generator and any one of the shock wave balloon catheters, wherein the pulse generator is electrically connected to the electrode assembly of the shock wave balloon catheter.

[0022] The present invention provides a shock wave balloon catheter and a catheter system. The shock wave balloon catheter includes a catheter shaft and a balloon. The balloon is arranged at the distal end of the catheter shaft. The shock wave balloon catheter also includes an electrode assembly and a reflection assembly. The electrode assembly is arranged on the catheter shaft and is used to release pulses, thereby generating shock waves in the balloon. The reflection assembly is arranged on the balloon and is used to reflect the shock waves toward the direction of the electrode assembly.

[0023] The shock wave balloon catheter provided by the present invention has a reflection component that can reflect shock waves. After the calcified lesion receives the shock wave reflected by the reflection component, the stress of the local calcified lesion can be enhanced, the shock wave catheter's ability to break up the calcified lesion in the predetermined position is increased, and the rupture rate and degree of the calcified lesion are improved. It is suitable for acting on asymmetric eccentric calcified lesions or calcified nodules in blood vessels, so as to improve the efficiency of lesion treatment, reduce operation time, reduce the total number of shock wave pulses, and reduce the discharge number requirements of the electrode assembly and the total treatment cycle energy.

[0024] In addition, by positioning the geometric center of the arc-shaped reflective component at the target tissue, a high-intensity focused shock wave can be formed after reflection from the reflective component, and the energy of the reflected shock wave can be concentrated on the calcified lesion to maximize the fragmentation of the calcified lesion. This can avoid the energy loss during the transmission of traditional shock waves to the surrounding area, achieve targeted treatment of calcified lesions, and improve the efficiency of lesion treatment. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] FIG1 is a schematic diagram of an axial cross-sectional structure of a catheter system according to a preferred embodiment of the present invention;

[0026] FIG2 is a schematic diagram of an axial cross-sectional structure of a portion of a shock wave balloon catheter in a preferred embodiment of the present invention;

[0027] FIG3 is a schematic diagram of a radial cross-sectional structure of a shock wave balloon catheter in a preferred embodiment of the present invention;

[0028] FIG4 is a schematic radial cross-sectional view of an application scenario of a shock wave balloon catheter in a preferred embodiment of the present invention;

[0029] FIG5 is a schematic diagram showing the working principle of a reflective assembly in a preferred embodiment of the present invention.

[0030] In the picture:

[0031] 1-catheter shaft; 2-balloon; 3-electrode assembly; 4-reflection assembly; 41-geometric center; 42-fixed position; 43-second straight line; 5-guide wire;

[0032] 10-predetermined site; 20-target tissue. DETAILED DESCRIPTION

[0033] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. The advantages and features of the present invention will become more apparent from the following description. It should be noted that the drawings are greatly simplified and not to exact scale, and are only used to facilitate and clearly illustrate the embodiments of the present invention.

[0034] The terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore should not be understood as limiting the present invention.

[0035] As used in this specification, "distal end" generally refers to the end of the shock wave guide tube away from the operator; the term "proximal end" is opposite to the "distal end" and generally refers to the end of the shock wave guide tube close to the operator; the term "axial direction" refers to the extension direction of the axis of the catheter shaft.

[0036] In the present invention, unless otherwise specified or limited, the terms "installed," "connected," "fixed," and the like should be understood broadly. For example, they may refer to fixed connections, detachable connections, or integration; mechanical connections, electrical connections, or communication between them; direct connections or connections through an intermediate medium; and internal communication between two components or interaction between two components, unless otherwise specified. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on specific circumstances.

[0037] The following exemplary embodiments of the present application are described in detail with reference to the accompanying drawings. In the absence of conflict, the following embodiments and features thereof may complement or be combined with each other.

[0038] As shown in Figures 1 to 4, a preferred embodiment of the present invention provides a shock wave balloon catheter, comprising a catheter shaft 1 and a balloon 2, wherein the balloon 2 is disposed on the catheter shaft 1. The shock wave balloon catheter further comprises an electrode assembly 3, which is disposed on the catheter shaft 1. The electrode assembly 3 is specifically fixed to the outer surface of the catheter shaft 1 and is located within the balloon 2. The balloon 2 is capable of contracting and inflating, and is configured to contact a predetermined portion 10 after being inflated. The electrode assembly 3 is configured to release pulses, thereby generating shock waves in the balloon 2.

[0039] Furthermore, the shock wave balloon catheter further includes a reflective component 4, which is disposed on the balloon 2. In one example, the reflective component 4 is fixedly connected to the balloon 2. The reflective component 4 is used to reflect the shock wave toward the electrode assembly 3.

[0040] More specifically, the shock wave balloon catheter can be implanted within a blood vessel and moved to a predetermined location 10 within the vessel, where target tissue 20 (e.g., a calcified lesion) is located. After the shock wave balloon catheter reaches the predetermined location 10, the reflector assembly 4 is positioned on the side of the electrode assembly 3 facing away from the target tissue. The electrode assembly 3 then releases a high-voltage pulse, which then acts on the target tissue 20. Simultaneously, the reflector assembly 4 resists the impact of the shock wave and reflects the shock wave toward the location of the electrode assembly 3, causing the reflected high-voltage pulse to act on the target tissue 20, thereby shattering the target tissue 20.

[0041] It should be understood that the predetermined location 10 generally refers to the vascular lining at the site of the lesion, i.e., the vascular lining surrounding the target tissue 20 in the vessel into which the shock wave balloon catheter is implanted, such as the vascular lining of a coronary artery. The target tissue 20 refers to a calcified lesion in the vascular lining, such as fibrosis or calcified spots. It should also be understood that the voltage range of the high-voltage pulse delivered by the electrode assembly 3 is preferably 1 kV to 20 kV.

[0042] A preferred embodiment of the present invention also provides a catheter system, including a pulse generator (such as a high-voltage pulse generator) and a shock wave balloon catheter, wherein the pulse generator is electrically connected to the electrode assembly 3 of the shock wave balloon catheter, and the pulse generator is used to provide the shock wave balloon catheter with the voltage required to generate shock waves.

[0043] When the shock wave balloon catheter is actually implanted, the balloon 2 and the reflective component 4 can be folded and transported to the predetermined location 10 . After the balloon 2 and the reflective component 4 arrive at the predetermined location 10 , the balloon 2 can be inflated and expanded to fit the predetermined location 10 .

[0044] After the shock wave balloon catheter reaches the predetermined location 10, the filling medium can be filled into or withdrawn from the balloon 2 to achieve expansion or contraction of the balloon 2. After the balloon 2 expands and fits the predetermined location 10, the electrode assembly 3 can perform arc discharge after receiving electrical energy from the pulse generator to create a short-duration high-voltage pulse in the balloon 2. The high-voltage pulse causes bubbles to form in the filling medium in the balloon 2 that is closer to the electrode assembly 3. The energy generated when the bubbles expand and burst acts on the adjacent filling medium, pushing the filling medium in the balloon 2 to generate a shock wave that moves toward the inner wall of the balloon 2. The shock wave propagates in the filling medium and strikes the calcified lesions in the blood vessels through the balloon wall, thereby cracking and breaking up the calcified lesions, restoring the elasticity of the blood vessels and reshaping the diseased blood vessels, while at the same time avoiding damage to the inner wall or endothelium of the blood vessels.

[0045] The shock wave balloon catheter provided by the present invention has a reflection component 4 that can reflect shock waves. After the calcified lesion receives the shock wave reflected by the reflection component 4, the stress of the local calcified lesion can be enhanced, the shock wave's ability to break up the calcified lesion in the predetermined position 10 (i.e., the target position 20) can be increased, and the rupture rate and degree of the calcified lesion can be improved. It is suitable for acting on asymmetric eccentric calcified lesions or calcified nodules in blood vessels to improve lesion treatment efficiency, reduce operation time, reduce the total number of shock wave pulses, and reduce the discharge number requirements of the electrode assembly and the total treatment cycle energy.

[0046] In addition, the shock wave balloon catheter sets the reflective component 4 on the side of the electrode component 3 away from the target tissue 20, so that the shock wave can be controlled to act on the local calcified lesion site, which can achieve targeted treatment of calcified lesions and avoid energy loss in the process of traditional shock waves being transmitted to the surrounding areas.

[0047] In the prior art, since the shock wave balloon catheter based on the electrohydraulic effect lacks a focusing component, the shock wave released is non-focused, making it difficult to control the location and degree of calcification lesion fragmentation by the balloon catheter.

[0048] To solve the above problems, as shown in Figures 3 to 5, in a preferred embodiment, the reflective component 4 is an arc-shaped structure, the concave surface of the reflective component 4 faces the electrode component 3, and the reflective component 4 is used to emit shock waves to the target tissue 20. The geometric center 41 (i.e., the focusing point) of the reflective component 4 can be located at the target tissue 20.

[0049] This arrangement positions the geometric center 41 of the arcuate reflective component 4 at the target tissue 20, allowing the reflective component to generate a high-intensity focused shock wave after reflection. In other words, the shock wave balloon catheter can focus the energy of the reflected shock wave through the arcuate reflective component 4, thereby focusing the shock wave energy reflected by the reflective component 4 at a single point, allowing the shock wave to more effectively act on a localized area of ​​the predetermined site 10. By positioning the target tissue 20 at the focal point of the reflective component 4, the reflective component 4 can focus the reflected high-intensity shock wave energy on calcified lesions to maximize their fragmentation. This avoids energy loss during the propagation of traditional shock waves, achieves targeted treatment of calcified lesions, and improves lesion treatment efficiency.

[0050] The present application does not limit the fixing position of the reflective component 4 on the balloon 2 . The reflective component 4 can be fixed on the inner surface or the outer surface of the balloon 2 .

[0051] 3 to 5 , in a specific embodiment, the reflective component 4 is disposed outside the balloon 2 and fixedly connected to the outer surface of the balloon 2 .

[0052] Preferably, the location where the reflective assembly 4 is connected to the balloon 2 is defined as a fixed location 42, a tangent line to the balloon 2 at the fixed location 42 is defined as a first straight line (unnumbered), and a straight line passing through the geometric center of the balloon 2 and perpendicular to the first straight line is defined as a second straight line 43. The reflective assembly 4 is symmetrically arranged about the second straight line 43, so that the geometric center 41 of the reflective assembly 4 is located on the second straight line 43. This facilitates focusing the shock wave reflected by the reflective assembly 4 on the geometric center 41 of the reflective assembly 4, thereby achieving concentration of the shock wave energy.

[0053] In this embodiment, the radius of the reflective component 4 is greater than the radius of the balloon 2. At this time, the radius of the reflective component 4 can be set as needed so that the geometric center 41 of the reflective component 4 is located at the target tissue 20 within the predetermined position 10, thereby focusing the high-energy shock wave reflected by the reflective component 4 on the target tissue 20.

[0054] In another embodiment, the reflective component 4 is fixed to the inner surface of the balloon 2 to prevent interference with the inner wall of the blood vessel. In this case, the radius of the reflective component 4 is no greater than the radius of the balloon 2, and the geometric center 41 of the reflective component 4 is no longer located at the target tissue 20. In this case, the target tissue 20 can only receive a portion of the shock wave energy reflected by the reflective component 4 and undergo fragmentation.

[0055] In another specific embodiment, the reflective component 4 may be provided as part of the balloon 2, and the radius of the reflective component 4 may be the same as or different from the radius of the balloon 2. When the radius of the reflective component 4 is the same as that of the balloon 2, the geometric center 41 of the reflective component 4 coincides with the geometric center of the balloon 2, that is, the curvature of the reflective component 4 is consistent with the curvature of the balloon 2. In this case, the target tissue 20 can only receive a portion of the shock wave energy reflected by the reflective component 4 and be fragmented.

[0056] Preferably, in the cross section of the catheter shaft 1, the electrode assemblies 3 are symmetrically arranged about the second straight line 43. In one specific example, there is one electrode assembly 3, which is located on the second straight line 43, that is, on the line connecting the geometric center 41 and the fixed position 42 of the reflector assembly 4. This arrangement allows the reflector assembly 4 to receive and reflect the shock waves released by the electrode assembly 3 to a greater extent.

[0057] Furthermore, the shock wave balloon catheter has at least one of the following structures: the diameter of the balloon 2 after inflation is preferably 1 mm to 10 mm; the length of the balloon 2 in the axial direction of the catheter shaft 1 is preferably 6 mm to 150 mm; the length of the reflective component 4 in the axial direction of the catheter shaft 1 is preferably 5 mm to 120 mm, and the length of the reflective component 4 is less than the length of the balloon 2 in the axial direction of the catheter shaft 1; and the arc length of the reflective component 4 in a cross section perpendicular to the axial direction of the catheter shaft 1 is preferably 0.5 mm to 20 mm.

[0058] In actual design, the diameter and length of the balloon 2, as well as the length and arc length of the reflective component 4, can be set to various combinations of different size structures to adapt to the pathological conditions of different patients.

[0059] It should be noted that the diameter of the balloon 2 after inflation determines the position of the reflector assembly 4 relative to the electrode assembly 3 and the target tissue 20. That is, the diameter of the balloon 2 after inflation determines the distance between the electrode assembly 3 and the reflector assembly 4, and also determines the distance between the reflector assembly 4 and the target tissue 20. The diameter of the balloon 2 can affect the intensity of the shock wave reflected by the reflector assembly 4 and focused on the target tissue 20. The operator can design the diameter of the balloon 2 based on the size of the blood vessel.

[0060] It should also be noted that the arc length and fixed position of the reflective assembly 4 need to be designed based on the location of the target tissue 20 in the patient's blood vessels. Specifically, after knowing the location of the patient's target tissue 20, the operator can design the reflective assembly 4 so that its geometric center 41 is located at the target tissue 20. In other words, the operator can design the arc of the emitting assembly 4 based on the distance between the target tissue 20 and the reflective assembly 4. Furthermore, the operator can also design the fixed position 42 of the reflective assembly 4, the electrode assembly 3, and the target tissue 20 to be aligned in a straight line, so that the shock wave reflected by the reflective assembly 4 is focused on the target tissue 20.

[0061] Furthermore, the length of the reflective assembly 4 needs to be designed based on the size of the calcified spots in the blood vessels of different patients. Specifically, the operator can design the length of the reflective assembly 4 based on the energy value of the shock wave required to shatter the calcified spots, so that the reflective assembly 4 can receive and reflect the shock wave energy sufficient to shatter the calcified spots.

[0062] To ensure that reflective component 4 can reflect a greater amount of shock waves, the acoustic impedance of the material used to make reflective component 4 must differ significantly from the acoustic impedance of the medium filling balloon 2. This is because when the acoustic impedance of the material used to make reflective component 4 differs significantly from that of the medium filling balloon 2, reflective component 4 is more likely to resist shock waves, thereby redirecting them. On the other hand, when the acoustic impedance difference between the material used to make reflective component 4 and the medium filling balloon 2 is smaller, shock waves are more likely to bypass reflective component 4 and continue in their original propagation direction.

[0063] By making the acoustic impedance of the transmitting component 4 and the acoustic impedance of the filling medium in the balloon 2 have a large difference, the reflecting component 4 can reflect the shock wave to a large extent, even if the shock wave reflected by the reflecting component 4 has sufficient energy.

[0064] Generally speaking, the filling medium in balloon 2 is a mixture of physiological saline and contrast agent, which has a low acoustic impedance. Therefore, the acoustic impedance of reflective component 4 is preferably greater than the acoustic impedance of the filling medium in balloon 2. In this case, reflective component 4 can be made of a metal material or a polymer material with a high acoustic impedance to achieve a large difference between the acoustic impedance of reflective component 4 and the acoustic impedance of the filling medium in balloon 2.

[0065] Referring back to FIG. 2 , the number of electrode assemblies 3 can be one or more. Preferably, the number of electrode assemblies 3 is multiple. In this case, the electrode assemblies 3 can be three as shown in FIG. 2 , or two, four, or more. All electrode assemblies 3 can be spaced apart along the axial direction of the catheter shaft 1.

[0066] Furthermore, each electrode assembly 3 includes an inner electrode and an outer electrode (not shown), which are disposed opposite each other and are configured to interact with each other to generate pulses. Specifically, the opposing inner and outer electrodes are configured to generate arc discharges to generate high-voltage pulses, which act on the filling medium within the balloon 2 to generate shock waves that act on the balloon wall.

[0067] 2 , the catheter system further includes a wire 5 , one end of which is connected to the pulse generator, and the other end of which is respectively connected to the inner electrode and the outer electrode in each electrode assembly 3 .

[0068] 2 and 3 , in a preferred embodiment, the cross-sections of the inner and outer electrodes (i.e., the cross-sections perpendicular to the axis of the catheter shaft 1) are both arc-shaped. In another preferred embodiment, the cross-sections of the inner and outer electrodes may also be square, rectangular, or other suitable shapes.

[0069] The present application does not limit the fixed positions of the inner and outer electrodes. In a specific example, the inner and outer electrodes in each electrode assembly 3 are spaced apart in the circumferential direction of the catheter shaft 1. In this case, the inner and outer electrodes are connected end to end to form a ring that is sleeved on the catheter shaft 1.

[0070] In another specific example, the inner electrodes and outer electrodes in each electrode assembly 3 may also be arranged at intervals in the axial direction of the catheter shaft 1 . In this case, the inner electrodes and outer electrodes that cooperate with each other are arranged relatively in the axial direction of the catheter shaft 1 .

[0071] In summary, the shock wave balloon catheter provided by the present invention has a reflection component 4 that can reflect shock waves. After the calcified lesion receives the shock wave reflected by the reflection component 4, the stress of the local calcified lesion can be enhanced, the ability of the shock wave to break up the calcified lesion in the predetermined part 10 can be increased, and the rupture rate and degree of the calcified lesion can be improved. It is suitable for acting on asymmetric eccentric calcified lesions or calcified nodules in blood vessels to improve the efficiency of lesion treatment, reduce operation time, reduce the total number of shock wave pulses, and reduce the discharge number requirements of the electrode assembly and the total treatment cycle energy.

[0072] In addition, by positioning the geometric center 41 of the arc-shaped reflective component 4 at the target tissue 20, the reflective component 4 can form a high-intensity focused shock wave after reflection, and concentrate the energy of the reflected shock wave at the calcified lesion to maximize the fragmentation of the calcified lesion. This can avoid the energy loss during the transmission of traditional shock waves to the surroundings, achieve targeted treatment of calcified lesions, and improve the efficiency of lesion treatment.

[0073] The above description is only a description of the preferred embodiments of the present invention and does not limit the scope of the present invention. Any changes and modifications made by ordinary technicians in the field of the present invention based on the above disclosure are within the scope of protection of the present invention.

Claims

1. A shock wave balloon catheter comprising a catheter shaft and a balloon, wherein the balloon is disposed at the distal end of the catheter shaft, characterized in that: The shock wave balloon catheter also includes an electrode assembly and a reflection assembly; the electrode assembly is arranged on the catheter shaft, and the electrode assembly is used to release pulses, thereby generating shock waves in the balloon; the reflection assembly is arranged on the balloon and is used to reflect the shock waves in the direction of the electrode assembly.

2. The shock wave balloon catheter according to claim 1, wherein: The reflective component is arranged outside the balloon and is fixedly connected to the outer surface of the balloon.

3. The shock wave balloon catheter according to claim 1, wherein: The reflective component is an arc-shaped structure, the inner concave surface of the reflective component faces the electrode component, the reflective component is used to reflect shock waves toward the target tissue, and the geometric center of the reflective component can be located at the target tissue.

4. The shock wave balloon catheter according to claim 2, wherein: On the cross section of the catheter shaft, the position where the reflective component is connected to the balloon is defined as a fixed position, the tangent line of the balloon at the fixed position is defined as a first straight line, and the straight line passing through the geometric center of the balloon and perpendicular to the first straight line is defined as a second straight line; the reflective component is symmetrically arranged about the second straight line.

5. The shock wave balloon catheter according to claim 4, characterized in that: In a cross section of the catheter shaft, the electrode assembly is symmetrically arranged about the second straight line.

6. The shock wave balloon catheter according to claim 1, wherein: The acoustic impedance of the reflective component is greater than the acoustic impedance of the medium filled in the balloon.

7. The shock wave balloon catheter according to claim 1, wherein: The shock wave balloon catheter has at least one of the following structures: The length of the reflective component in the axial direction of the catheter shaft is 5 mm to 120 mm; The arc length of the reflective component on the cross section perpendicular to the axial direction of the catheter axis is 0.5 mm to 20 mm; The diameter of the balloon after inflation is 1 mm to 10 mm; The length of the balloon in the axial direction of the catheter shaft is 6 mm to 150 mm.

8. The shock wave balloon catheter according to any one of claims 1 to 7, characterized in that: The number of the electrode assemblies is at least one group, and each group of the electrode assemblies includes an inner electrode and an outer electrode. The inner electrode and the outer electrode are arranged opposite to each other, and the inner electrode and the outer electrode interact with each other to generate pulses.

9. The shock wave balloon catheter according to claim 8, characterized in that: The cross sections of the inner electrode and the outer electrode are both arc-shaped; the inner electrodes and the outer electrodes in each group of the electrode assemblies are spaced apart in the circumferential direction of the catheter shaft.

10. The shock wave balloon catheter according to claim 8, wherein: The electrode assemblies are arranged in a plurality of groups, and all the groups of electrode assemblies are spaced apart along the axial direction of the catheter shaft.

11. A catheter system, characterized in that: The invention comprises a pulse generator and the shock wave balloon catheter according to any one of claims 1 to 10, wherein the pulse generator is electrically connected to the electrode assembly of the shock wave balloon catheter.

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