CN117814869A - Shock wave balloon catheter and catheter system - Google Patents

Abstract

The invention provides a shock wave balloon catheter and a catheter system. The shock wave balloon catheter includes a catheter shaft and a balloon disposed on the catheter shaft. The shock wave balloon catheter also comprises an electrode assembly and a reflecting assembly, wherein the electrode assembly is arranged on the catheter shaft and is used for releasing pulses so as to generate shock waves in the balloon; the reflecting component is arranged on the balloon and is used for reflecting the shock wave towards the direction of the electrode component. The shock wave balloon catheter can enhance the fragmentation capability of target tissues, reduce the operation time and realize the directional treatment of the target tissues.

Description

Shock wave balloon catheters and catheter systems

Technical Field

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 technique

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 are prone to 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 vessel.

To solve the above problems, a shock wave balloon catheter is provided in the prior art. The balloon catheter uses the hydroelectric effect to destroy the fibrosis or calcification spots in the blood vessels. The principle is to perform arc discharge on the relative electrodes to create a high-voltage pulse of short duration (<10ms) in the blood vessels, and then generate a high-energy sound wave (i.e., shock wave) with strong sound pressure. The high-energy sound wave propagates to the calcified plaques on the blood vessels. Similar to the fracture of any fragile object, the stress generated by the shock wave causes the calcification to begin to form cracks. At the same time, under the repeated action of the shock wave, the calcified cracks further disintegrate and break, and the broken calcified lesions can expand under low pressure, so as to avoid the problem of sudden and substantial expansion of the blood vessels under the high pressure of the balloon in traditional angioplasty, thereby causing damage to the blood vessel wall.

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.

Summary of the invention

The object of the present invention is to provide a shock wave balloon catheter and a catheter system, wherein the catheter can enhance the fragmentation capability of target tissue, reduce operation time, and achieve directional treatment of target tissue.

To achieve the above-mentioned purpose, 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 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 wave in the direction of the electrode assembly.

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

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.

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 line of the balloon at the fixed position is defined as a first straight line, and a 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.

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

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

Optionally, 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 being filled 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.

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.

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.

Optionally, the electrode assemblies are provided in a plurality of groups, and all groups of the electrode assemblies are arranged at intervals along the axial direction of the catheter axis.

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 an electrode assembly of the shock wave balloon catheter.

The present invention provides a shock wave balloon catheter and a catheter system. The shock wave balloon catheter comprises a catheter shaft and a balloon. The balloon is arranged at the distal end of the catheter shaft. The shock wave balloon catheter also comprises 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 in the direction of the electrode assembly.

The shock wave balloon catheter provided by the present invention has a reflection component capable of reflecting 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 crushing ability of the shock wave catheter on the calcified lesion in the predetermined part 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 to improve the lesion treatment efficiency, reduce the operation time, reduce the total pulse number of the shock wave, and reduce the discharge number requirement of the electrode assembly and the total treatment cycle energy.

In addition, by locating the geometric center of the arc-shaped reflective component at the target tissue, a high-intensity focused shock wave can be formed after reflection by 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 of traditional shock waves in the process of transmitting to the surroundings, achieve targeted treatment of calcified lesions, and improve the efficiency of lesion treatment.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG1 is a schematic diagram of an axial cross-sectional structure of a catheter system in a preferred embodiment of the present invention;

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;

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;

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;

FIG. 5 is a schematic diagram showing the working principle of a reflective assembly in a preferred embodiment of the present invention.

In the figure:

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

10-predetermined site; 20-target tissue.

Detailed ways

The present invention is further described in detail below in conjunction with 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 accompanying drawings are in very simplified form and in non-precise proportions, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention.

The orientation or position relationship indicated by 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 are based on the orientation or position relationship shown in the drawings and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the referred device or element must have a specific orientation, be constructed and operate in a specific orientation, and therefore should not be understood as limiting the present invention.

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.

In the present invention, unless otherwise clearly specified and limited, the terms "installation", "connection", "fixation" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection, an electrical connection, or communication with each other; it can be a direct connection, or a connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

The exemplary embodiments of the present application are described in detail below in conjunction with the accompanying drawings. In the absence of conflict, the following embodiments and features in the embodiments may complement or be combined with each other.

As shown in Figures 1 to 4, a preferred embodiment of the present invention provides a shock wave balloon catheter, including a catheter shaft 1 and a balloon 2, wherein the balloon 2 is arranged on the catheter shaft 1. The shock wave balloon catheter also includes an electrode assembly 3, wherein the electrode assembly 3 is arranged on the catheter shaft 1. The electrode assembly 3 is specifically fixed on the outer surface of the catheter shaft 1 and is located inside the balloon 2. The balloon 2 can be contracted and inflated, and is used to contact a predetermined part 10 after being inflated. The electrode assembly 3 is used to release pulses, thereby generating shock waves in the balloon 2.

Furthermore, the shock wave balloon catheter further includes a reflection component 4, which is disposed on the balloon 2. In one example, the reflection component 4 is fixedly connected to the balloon 2. The reflection component 4 is used to reflect the shock wave toward the direction of the electrode component 3.

In more detail, the shock wave balloon catheter can be implanted in a blood vessel and moved to a predetermined position 10 in the blood vessel, wherein the predetermined position 10 has a target tissue 20 (e.g., a calcified lesion). After the shock wave balloon catheter moves to the predetermined position 10, the reflective component 4 is located on the side of the electrode component 3 away from the target tissue. The electrode component 3 is made to release a high-voltage pulse, which can act on the target tissue 20. At the same time, the reflective component 4 can resist the impact of the shock wave and can reflect the shock wave toward the position of the electrode component 3, so that the reflected high-voltage pulse acts on the target tissue 20, thereby achieving the purpose of shattering the target tissue 20.

It should be understood that the predetermined part 10 generally refers to the inner wall of the blood vessel at the lesion part, that is, the inner wall of the blood vessel covering the target tissue 20 in the blood vessel where the shock wave balloon catheter is implanted, such as the inner wall of the blood vessel of the coronary artery. The target tissue 20 refers to the calcified lesion in the inner wall of the blood vessel, such as fibrosis or calcified spots. It should also be understood that the voltage range of the high-voltage pulse released by the electrode assembly 3 is preferably 1KV to 20KV.

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.

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 .

After the shock wave balloon catheter reaches the predetermined position 10, the filling medium can be filled into or withdrawn from the balloon 2 to achieve the expansion or contraction of the balloon 2. After the balloon 2 expands and fits the predetermined position 10, the electrode assembly 3 can perform arc discharge after receiving the electrical energy of the pulse generator to create a short-duration high-voltage pulse in the balloon 2. The high-voltage pulse causes bubbles to be generated in the filling medium in the balloon 2 that is close to the electrode assembly 3. The energy generated when the bubbles expand and burst acts on the adjacent filling medium to push the filling medium in the balloon 2 to generate a shock wave moving toward the inner wall of the balloon 2. The shock wave propagates in the filling medium and hits the intravascular calcified lesions through the balloon wall to crack and break the calcified lesions, restore the elasticity of the blood vessels and reshape the diseased blood vessels, while avoiding damage to the inner wall or endothelium of the blood vessels.

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 the calcified lesion in the predetermined position 10 (i.e., the target position 20) 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 to improve the efficiency of lesion treatment, reduce the 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.

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 transmitting to the surroundings.

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, which makes it difficult to control the position and degree of the calcified lesions broken by the balloon catheter.

To solve the above problems, referring to 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.

In this way, the geometric center 41 of the arc-shaped reflective component 4 is located at the target tissue 20, so that the reflective component can form a high-intensity focused shock wave after reflection. That is to say, the shock wave balloon catheter can achieve energy focusing of the reflected shock wave through the arc-shaped reflective component 4, and then focus the shock wave energy reflected by the reflective component 4 at one point, so that the shock wave can act more effectively on the local area of the predetermined part 10. By setting the target tissue 20 at the focal position of the reflective component 4, the reflective component 4 can focus the reflected high-intensity shock wave energy on the calcified lesion to break up the calcified lesion to the maximum extent, thereby avoiding the energy loss of the traditional shock wave in the process of transmitting to the surroundings, achieving directional treatment of calcified lesions, and improving the efficiency of lesion treatment.

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

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 .

Preferably, the position where the reflective component 4 is connected to the balloon 2 is defined as a fixed position 42, the tangent line of the balloon 2 at the fixed position 42 is defined as a first straight line (not numbered), and the 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 component 4 is symmetrically arranged about the second straight line 43, so that the geometric center 41 of the reflective component 4 is located on the second straight line 43. This can help the shock wave reflected by the reflective component 4 to focus on the geometric center 41 of the reflective component 4, thereby achieving the concentration of shock wave energy.

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 in the predetermined position 10, thereby focusing the high-energy shock wave reflected by the reflective component 4 on the target tissue 20.

In another specific embodiment, the reflective component 4 is fixed to the inner surface of the balloon 2 to avoid interference of the reflective component 4 with the inner wall of the blood vessel. In this case, the radius of the reflective component 4 is not 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. At this time, the target tissue 20 can only receive part of the shock wave energy reflected by the reflective component 4 and be fragmented.

In another specific embodiment, the reflective component 4 may also be provided as a 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 the radius 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 part of the shock wave energy reflected by the reflective component 4 and be fragmented.

Preferably, on the cross section of the catheter shaft 1, the electrode assembly 3 is symmetrically arranged about the second straight line 43. In a specific example, the number of the electrode assembly 3 is one, and the electrode assembly 3 is located on the second straight line 43, that is, the electrode assembly 3 is located on the line between the geometric center 41 and the fixed position 42 of the reflective assembly 4. In this way, the reflective assembly 4 can receive and reflect the shock wave released by the electrode assembly 3 to a large extent.

Further, the shock wave balloon catheter has at least one of the following structures: the diameter of the balloon 2 after filling 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; the arc length of the reflective component 4 in the cross section perpendicular to the axial direction of the catheter shaft 1 is preferably 0.5 mm to 20 mm.

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 a variety of combinations of different size structures to adapt to the pathological conditions of different patients.

It should be noted that the diameter of the balloon 2 after filling and expansion determines the position of the reflective component 4 relative to the electrode component 3 and the target tissue 20 after the balloon 2 is filled, that is, the diameter of the balloon 2 after filling determines the distance between the electrode component 3 and the reflective component 4, and also determines the distance between the reflective component 4 and the target tissue 20. The diameter of the balloon 2 can affect the intensity of the shock wave reflected by the reflective component 4 and focused and transmitted to the target tissue 20. The operator can design the diameter of the balloon 2 according to the size of the blood vessel.

It should also be noted that the arc length and fixed position of the reflective component 4 need to be designed according to the position of the target tissue 20 in the blood vessels of different patients. Specifically, after knowing the position of the target tissue 20 of the patient, the operator can design the reflective component 4 with the geometric center 41 located at the position of the target tissue 20, that is, the operator can design the arc of the transmitting component 4 according to the distance between the target tissue 20 and the reflective component 4. At the same time, the operator can also design the fixed position 42 of the reflective component 4, the electrode component 3 and the target tissue 20 to be on the same straight line, so that the shock wave reflected by the reflective component 4 can be focused on the target tissue 20.

In addition, the length of the reflective component 4 needs to be designed according to the size of the calcified spots in the blood vessels of different patients. Specifically, the operator can design the length of the reflective component 4 according to the energy value of the shock wave required to break the calcified spots, so that the reflective component 4 can receive and reflect the shock wave energy sufficient to break the calcified spots.

In order to ensure that the reflective component 4 can reflect more shock waves, the acoustic impedance of the material used to make the reflective component 4 needs to be significantly different from the acoustic impedance of the medium filled in the balloon 2. This is because when the acoustic impedance of the material used to make the reflective component 4 is significantly different from the acoustic impedance of the medium filled in the balloon 2, the reflective component 4 is more inclined to resist the shock wave to change the direction of travel of the shock wave. When the acoustic impedance of the material used to make the reflective component 4 is slightly different from the acoustic impedance of the medium filled in the balloon 2, the shock wave is more inclined to pass over the reflective component 4 and continue to travel in the original propagation direction.

Making the acoustic impedance of the transmitting component 4 and the acoustic impedance of the filling medium in the balloon 2 significantly different can enable the reflecting component 4 to reflect the shock wave to a greater extent, even if the shock wave reflected by the reflecting component 4 has sufficient energy.

Generally speaking, the filling medium in the balloon 2 is a mixed solution of physiological saline and contrast agent, and its acoustic impedance is relatively small. Therefore, the acoustic impedance of the reflective component 4 is preferably greater than the acoustic impedance of the filling medium in the balloon 2. In this case, the reflective component 4 can be made of metal material or a polymer material with relatively large acoustic impedance to achieve a relatively large difference between the acoustic impedance of the reflective component 4 and the acoustic impedance of the filling medium in the balloon 2.

Referring back to FIG. 2 , the number of electrode assemblies 3 can be one or more groups. The number of electrode assemblies 3 is preferably multiple groups, in which case the electrode assemblies 3 can be 3 groups as shown in FIG. 2 , or can be 2 groups, 4 groups or more groups. All groups of electrode assemblies 3 can be arranged at intervals along the axial direction of the catheter shaft 1.

Furthermore, each electrode assembly 3 includes an inner electrode and an outer electrode (not shown), which are arranged opposite to each other and are used to interact with each other to generate pulses. Specifically, the inner electrode and the outer electrode arranged opposite to each other are used to perform arc discharge to generate high-voltage pulses, and the high-voltage pulses act on the filling medium in the balloon 2 to generate shock waves acting on the balloon wall.

Continuing to refer to FIG. 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 .

2 and 3, in a preferred embodiment, the cross-sections of the inner electrode and the outer electrode (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 electrode and the outer electrode may also be square, rectangular or other suitable shapes.

The present application does not limit the fixed positions of the inner electrode and the outer electrode. In a specific example, the inner electrode and the outer electrode in each electrode assembly 3 are arranged at intervals in the circumferential direction of the catheter shaft 1, and the inner electrode and the outer electrode are connected end to end to form a ring sleeved on the catheter shaft 1.

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

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 the 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.

In addition, by locating 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 on the calcified lesion to maximize the fragmentation of the calcified lesion. This can avoid the energy loss of traditional shock waves in the process of transmitting to the surroundings, achieve targeted treatment of calcified lesions, and improve the efficiency of lesion treatment.

The above description is only a description of the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention. Any changes or modifications made by a person skilled in the art in the field of the present invention based on the above disclosure shall fall within the protection scope of the present invention.

Claims (11)

1. A shock wave balloon catheter comprising a catheter shaft and a balloon disposed at a distal end of the catheter shaft, wherein the shock wave balloon catheter further comprises an electrode assembly and a reflective assembly; the electrode assembly is arranged on the catheter shaft and is used for releasing pulses so as to generate shock waves in the balloon; the reflecting component is arranged on the balloon and is used for reflecting the shock wave towards the direction of the electrode component.

2. The shock wave balloon catheter of claim 1, wherein the reflective assembly is disposed outside of the balloon and fixedly connected to an outer surface of the balloon.

3. The shock wave balloon catheter according to claim 1, wherein the reflecting assembly is of arcuate configuration, the concave surface of the reflecting assembly facing the electrode assembly, the reflecting assembly being adapted to reflect shock waves toward a target tissue, the geometric center of the reflecting assembly being positionable at the target tissue.

4. The shock wave balloon catheter of claim 2, wherein, in a cross-section of the catheter shaft, a location at which the reflective assembly is connected to the balloon is defined as a fixed location, a tangent to the balloon at the fixed location is defined as a first straight line, and a straight line passing through a geometric center of the balloon and perpendicular to the first straight line is defined as a second straight line; the reflecting component is symmetrically arranged about the second line.

5. The shock wave balloon catheter of claim 4, wherein the electrode assembly is symmetrically disposed about the second line in a cross-section of the catheter shaft.

6. The shock wave balloon catheter of claim 1, wherein the acoustic impedance of the reflective assembly is greater than the acoustic impedance of the medium filled within the balloon.

7. The shock wave balloon catheter of claim 1, wherein the shock wave balloon catheter has at least one of the following structures:

the length of the reflecting component in the axial direction of the catheter shaft is 5 mm-120 mm;

the arc length of the reflecting component on the cross section perpendicular to the axial direction of the catheter shaft is 0.5 mm-20 mm;

the diameter of the balloon after filling is 1 mm-10 mm;

the length of the balloon in the axial direction of the catheter shaft is 6 mm-150 mm.

8. The shock wave balloon catheter according to any one of claims 1-7, wherein the number of electrode assemblies is at least one, each set of the electrode assemblies comprising an inner electrode and an outer electrode, the inner electrode and the outer electrode being disposed opposite each other, the inner electrode and the outer electrode interacting to generate a pulse.

9. The shock wave balloon catheter according to claim 8, wherein the inner electrode and the outer electrode are each arcuate in cross-section; the inner and outer electrodes in each set of the electrode assemblies are spaced apart in the circumferential direction of the catheter shaft.

10. The shock wave balloon catheter of claim 8, wherein the number of electrode assemblies is a plurality of groups, all groups of the electrode assemblies being spaced apart along the axial direction of the catheter shaft.

11. A catheter system comprising a pulse generator and the shock wave balloon catheter of any one of claims 1-10, the pulse generator being electrically connected to an electrode assembly of the shock wave balloon catheter.