Shock wave balloon device

Abstract

The invention relates to the technical field of medical instruments, in particular to a shock wave balloon device which comprises a handle structure and a balloon structure slidably arranged with the handle structure. The handle structure comprises a handle arranged at the near end and an outer tube fixedly arranged at the far end of the handle. Wherein a sliding button is arranged on the handle in a sliding manner, and the sliding button is fixedly connected with the near end of the balloon structure; the balloon structure comprises a middle tube, an inner tube, a balloon and a tip tube, wherein the near end of the middle tube is fixedly connected with the sliding button, the inner tube is fixedly and coaxially sleeved with the middle tube, the balloon is fixedly arranged at the far end of the middle tube, and the tip tube is fixedly arranged at the far end of the balloon. The balloon in a special shape is utilized, the balloon is centered among the three valve leaflets, the balloon is matched with the clamping arms in a special shape, trauma to a patient is reduced, and meanwhile visual operation of a doctor is increased.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and particularly to a shock wave balloon device. Background Art

[0002] As a common valvular heart disease, calcific aortic valve disease (CAVD) has a disease spectrum covering a series of conditions from aortic valve sclerosis to calcific aortic stenosis (AS). Aortic valve sclerosis is often a pre - manifestation of aortic valve stenosis. Approximately 9% of aortic valve sclerosis cases will progress to stenosis within 5 years. Cardiovascular health research shows that about 1% - 2% of aortic valve sclerosis cases develop into stenosis each year, and 75% of these patients will need to undergo valve replacement surgery due to heart failure or die within 2 - 5 years. The leaflet stiffness of calcific aortic stenosis gradually increases in the clinical pathogenesis, and the late - stage lesions are similar to bone formation, with calcification as a significant feature. Currently, transcatheter aortic valve implantation (TAVI) is the main treatment for calcific aortic stenosis, while drug treatment is still in the research stage.

[0003] Although artificial valves have been proven to have certain safety and effectiveness in clinical applications, their surgical costs are high, and there are death risks (EuroSCORE≥20%, STS≥10%). In addition, artificial valves will recalcify and fail over time. With the gradual promotion of the concept of "interventional without implantation", both doctors and patients are more expecting a low - risk, non - implantable device that can soften the valve, thereby delaying the time of artificial valve implantation instead of directly performing valve replacement surgery, and also expecting to improve the valve function of calcified artificial valve prostheses.

[0004] In recent years, intravascular shock wave technology has been continuously developing. In terms of intracoronary balloon shock wave lithotripsy, clinical research data of multiple companies at home and abroad have been successively published, fully demonstrating the safety and effectiveness of intravascular shock wave treatment for calcification. In the field of heart valves, the Journal of the Society for Cardiovascular Angiography and Interventions (JSCAI) and the Journal of the American College of Cardiology (JACC) reported cases of shock wave balloon - assisted treatment of mitral valve calcification. Cardiawave Company used extracorporeal ultrasound technology to treat 10 patients with aortic calcification and successfully verified the feasibility of ultrasound treatment for aortic calcification. Many foreign companies and institutions have conducted in - depth explorations on ultrasonic cavitation effects and shock wave cavitation effects for treating valve calcification, and the results show that they can effectively soften calcified valves and biological tissues. Based on these research results, the present invention focuses on the application of shock wave cavitation effects, and is committed to designing a safe, convenient and efficient device. By applying shock waves to calcified valves, promoting valve calcification fractures, and then achieving the purpose of softening the valves, so as to meet the urgent needs of the current cardiovascular disease treatment field for low - risk, non - implantable treatment options. Summary of the Invention

[0005] The purpose of the present invention is to provide a shock wave balloon device in view of the deficiencies in the prior art;

[0006] To achieve the above object, the technical solution adopted by the present invention is:

[0007] The present invention provides a shock wave balloon device, comprising: a handle structure, and a balloon structure slidably arranged with the handle structure; wherein:

[0008] The handle structure comprises: a handle arranged at the proximal end, and an outer tube fixedly arranged at the distal end of the handle;

[0009] Wherein, a sliding button is slidably provided on the handle, and the sliding button is fixedly connected to the proximal end of the balloon structure;

[0010] The balloon structure comprises: a middle tube whose proximal end is fixedly connected to the sliding button, an inner tube fixedly and coaxially sleeved inside the middle tube, a balloon fixedly arranged at the distal end of the middle tube, and a tip tube fixedly arranged at the distal end of the balloon;

[0011] Wherein, the middle tube and the outer tube are slidably matched, and the balloon is sleeved on the outside of the inner tube.

[0012] Further, the proximal end of the inner tube passes through the balloon, the middle tube is coaxially sleeved outside the inner tube, the outer tube is coaxially sleeved outside the middle tube, and the proximal end of the tip tube is fixedly arranged at the distal end of the balloon.

[0013] Wherein, a clamping arm device is fixedly provided at the distal end of the outer tube, and a hemostatic valve is fixedly provided at the proximal end of the outer tube;

[0014] The distal end of the inner tube is fixedly connected to the proximal end of the tip tube, and the tip tube is coaxial with the inner tube;

[0015] There is a first gap between the inner tube and the middle tube, thereby forming a first channel, and there is a second gap between the middle tube and the outer tube, thereby forming a second channel, and the first channel is connected to the cavity in the balloon;

[0016] Wherein, two opposite outer cavities are provided on the outer wall of the inner tube, a plurality of electrode assemblies are fixedly arranged in the inner tube, and a positive electrode line and a negative electrode line are fixedly arranged in the two opposite outer cavities respectively;

[0017] The handle comprises: a main body, a joint, and a sliding button; wherein the main body has a cavity inside, the hemostatic valve is fixedly arranged in the main body, the joint is slidably arranged at the proximal end of the main body, the proximal end of the joint penetrates the proximal end of the main body, a groove is opened on one side of the main body, the sliding button is slidably arranged in the groove, and one side of the sliding button is fixedly arranged on the proximal outer wall of the intermediate tube;

[0018] Wherein, the proximal ends of the intermediate tube and the inner tube are fixedly connected to the distal end of the joint.

[0019] Furthermore, the joint includes: a third channel, a fourth channel, and a fifth channel; wherein,

[0020] The third channel, the fourth channel, and the fifth channel pass through the main body. The third channel is communicated with the lumen of the inner tube. The fourth channel is for the positive wire and the negative wire to pass through. The fifth channel is communicated with the first channel.

[0021] Further, the clamping arm device comprises: a metal seat, and three clamping arms fixedly arranged at the distal end of the metal seat;

[0022] The cross section of the metal seat is hexagonal, the head end of the clamping arm is a flat arc, each of the clamping arms has two feet, the leg of each clamping arm is fixedly arranged at the vertex of each metal seat, the wire diameter of the head end of the clamping arm is smaller than the wire diameter of the leg of the clamping arm, and the outer surface of the clamping arm is coated or covered with a lubricating material;

[0023] The distance between the head end of the clamping arm and the distal end of the metal seat is 1 cm to 3 cm, and the diameter of the fitting circle of the open dimensions of the head ends of the three clamping arms is 1.0 cm to 3.5 cm.

[0024] Furthermore, the balloon is in the shape of an arc triangular pyramid, the angle of the cone of the cone surface of the balloon is 28° to 60°, the axial lengths of the arc surface and the cone surface of the balloon are equal, and the length of the cone surface of the balloon is 1cm to 5cm.

[0025] Furthermore, the bending angle of the distal end of the clamping arm matches the angle of the cone of the conical surface of the balloon, and the axial length of the clamping arm matches the axial length of the conical surface of the balloon.

[0026] Further, the hemostatic valve comprises: a first outlet channel, and a second outlet channel;

[0027] Wherein, a silicone sealing ring is fixedly arranged in the first outlet channel, the proximal end of the intermediate tube passes through the silicone sealing ring, and the silicone sealing ring is used to seal the second channel;

[0028] Wherein, the second outlet channel is communicated with the second channel, the side of the second outlet channel away from the outer tube penetrates the side wall of the main body, and the second outlet channel is fixedly connected to a three-way valve;

[0029] Among them, the compressive strength of the silicone sealing ring is 200psi to 500psi.

[0030] Furthermore, the outer tube is composed of a connecting section, a soft section, and a pushing section from the distal end to the proximal end;

[0031] The soft segment and the push segment are woven from braided wires. The hardness of the push segment is greater than that of the soft segment. The hardness of the soft segment is 35D to 55D. The length of the soft segment is 10cm to 35cm.

[0032] The inner wall of the outer tube is coated with a PTFE coating or a lubricant.

[0033] Furthermore, the clamping arm is made of nickel-titanium memory alloy material;

[0034] The intermediate tube includes: a distal section and a proximal section; the distal section is a braided tube made of braided wire, the hardness of the distal section is 50D-70D, the proximal section of the intermediate tube is a metal tube, and the length of the proximal section is greater than the distance from the joint to the three-way valve sealing rubber ring. Further, the electrode assembly is three groups;

[0035] The three groups of electrode assemblies are coaxially arranged, and the electrode assemblies include, from the inside to the outside, an inner electrode, an insulating tube, and an outer electrode; a plurality of discharge holes are provided on the insulating tube and the outer electrode, and the three groups of electrode assemblies are connected in series;

[0036] Among them, the inner electrode of the first electrode group is connected to the negative electrode line, the outer electrode of the first electrode group is connected to the outer electrode of the second electrode group, the inner electrode of the second electrode group is connected to the inner electrode of the third electrode group, and the outer electrode of the third electrode group is connected to the positive electrode line.

[0037] The present invention adopts the above technical solution, and has the following technical effects compared with the prior art:

[0038] The present invention utilizes a balloon of a special shape, which is centered between the three leaflets. The balloon cooperates with a clamping arm of a special shape to make the valve stick to the balloon. The curvature of the balloon serves as a fulcrum, and the two legs of the clamping arm apply force in the direction of the fulcrum. While clamping the valve, it is easier to fracture the calcified valve. The centered balloon does not contact the valve ring, reducing the impact of shock wave energy on heart point conduction. The three clamping arms clamp the three valves to avoid the impact of heart beating on the surgical process. The three clamping arms clamp the three valves at the same time for shock wave treatment, thereby increasing surgical efficiency. During treatment, the device is provided with angiography channels above the valve (first channel) and below the valve (second channel), and no additional angiography catheter intervention is required, thereby reducing trauma to the patient and increasing the doctor's visualized operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1 It is a structural schematic diagram of the present invention;

[0040] Figure 2 It is a schematic diagram of the enlarged structure of region A in the present invention;

[0041] Figure 3 It is a schematic diagram of the cross-sectional structure of the inner tube in the present invention;

[0042] Figure 4 It is a schematic structural diagram of the arc surface of the balloon in the present invention;

[0043] Figure 5 It is a schematic diagram of the structure of the electrode assembly in the present invention;

[0044] Figure 6 It is a schematic diagram of the cross-sectional structure of the outer tube, the middle tube, and the inner tube in the present invention;

[0045] Figure 7 It is a schematic structural diagram of the clamping arm device in the present invention;

[0046] The reference numerals in the accompanying drawings are:

[0047] Handle, 9; sliding button, 92; connector, 91; third channel, 911; fourth channel, 12; fifth channel, 913; balloon, 1; intermediate tube, 3; inner tube, 2; tip tube, 8; first channel, 5; second channel, 6; outer cavity 7; positive wire, 71; negative wire, 72; outer tube, 4; clamping arm device, 10; metal seat, 11; clamping arm, 12; hemostatic valve, 13; first outlet channel, 131; second outlet channel, 132; three-way valve, 133; first electrode group, 21; second electrode group, 22; third electrode group, 23. DETAILED DESCRIPTION

[0048] The specific embodiments of the present invention will be described in detail below.

[0049] Unless otherwise defined, technical or scientific terms used in the claims and the specification shall have the common meanings understood by persons having ordinary skills in the technical field to which the present invention belongs.

[0050] The words "include" or similar words used in the patent application specification and claims of the present invention mean that the items appearing before "include" include the items listed after "include" or their equivalents, and do not exclude other items.

[0051] The numerical values ​​mentioned in the present invention include all numerical values ​​that increase from low to high by one unit, assuming that there are at least two units between any lower value and the higher value. For example, if a component or a physical quantity is said to be from 1 to 100, 10 to 90 is more preferred, and 20 to 80 is the most preferred, it is intended to express that values ​​such as 5 to 95, 14 to 76, 23 to 67, 32 to 58, 41 to 49 are clearly listed in this specification; for values ​​less than 1, 0.0001, 0.001, 0.01 or 0.1 are considered to be more suitable as a unit. The above examples are for illustrative purposes only. In fact, all numerical combinations between the lowest value and the highest value listed are deemed to be clearly listed in this specification in a similar manner.

[0052] Example 1

[0053] This embodiment provides a shock wave balloon device, comprising: a handle structure, and a balloon structure slidably arranged with the handle structure; wherein:

[0054] The handle structure comprises: a handle 9 arranged at the proximal end, and an outer tube 4 fixedly arranged at the distal end of the handle 9;

[0055] The handle 9 is slidably provided with a sliding button 92, which is fixedly connected to the proximal end of the balloon structure. The handle 9 provided at the proximal end is convenient for doctors to hold and operate, and its distal end is fixedly connected to the outer tube 4. The sliding button 92 on the handle 9 is fixedly connected to the proximal end of the balloon structure, and the movement of the balloon structure can be accurately controlled by the sliding button 92;

[0056] The balloon structure includes: an intermediate tube 3 whose proximal end is fixedly connected to the sliding button 92, an inner tube 2 fixedly and coaxially sleeved inside the intermediate tube 3, a balloon 1 fixedly arranged at the distal end of the intermediate tube 3, and a tip tube 8 fixedly arranged at the distal end of the balloon 1;

[0057] Among them, the middle tube 3 is slidably matched with the outer tube 4, the balloon 1 is sleeved on the outside of the inner tube 2, the distal end of the inner tube 2 is fixedly connected to the proximal end of the tip tube 8, and the tip tube 8 is coaxial with the inner tube 2; the balloon 1 is an arc triangular pyramid, the cone angle of the cone surface of the balloon 1 is 28°, the arc surface and the axial length of the cone surface of the balloon 1 are equal, and the cone surface length of the balloon 1 is 3cm.

[0058] The proximal end of the inner tube 2 penetrates the balloon 1, the middle tube 3 is coaxially sleeved on the outside of the inner tube 2, the outer tube 4 is coaxially sleeved on the outside of the middle tube 3, and the proximal end of the tip tube 8 is fixedly arranged on the distal end of the balloon 1.

[0059] Wherein, a clamping arm device 10 is fixedly provided at the distal end of the outer tube 4, and a hemostatic valve 13 is fixedly provided at the proximal end of the outer tube 4;

[0060] There is a first gap between the inner tube 2 and the middle tube 3, thereby forming a first channel 5, and there is a second gap between the middle tube 3 and the outer tube 4, thereby forming a second channel 6. The first channel 5 is connected to the cavity in the balloon 1, and the balloon 1 is filled with contrast agent, and the contrast agent in the balloon 1 flows into the first channel 5;

[0061] The outer wall of the inner tube 2 is provided with two opposite outer cavities 7, a plurality of electrode assemblies are fixedly arranged in the inner tube 2, and the two opposite outer cavities 7 are respectively fixedly arranged with a positive electrode line 71 and a negative electrode line 72;

[0062] The handle 9 comprises: a main body, a joint 91, and a sliding button 92; wherein the main body has a cavity inside, the hemostatic valve 13 is fixedly arranged in the main body, the joint 91 is slidably arranged at the proximal end of the main body, the proximal end of the joint passes through the proximal end of the main body, a groove is provided on one side of the main body, the sliding button 92 is slidably arranged in the groove, one side of the sliding button 92 is fixedly arranged on the proximal outer wall of the intermediate tube 3, the proximal ends of the intermediate tube 3 and the inner tube 2 are fixedly connected to the distal end of the joint 91, wherein when the sliding button 92 is pushed, the sliding button 92 drives the intermediate tube 3 to move, and the balloon 1 moves following the intermediate tube 3;

[0063] The joint 91 includes a third channel 911, a fourth channel 912, and a fifth channel 913;

[0064] The third channel 911, the fourth channel 912, and the fifth channel 913 run through the main body, the third channel 911 is communicated with the lumen 14 of the inner tube 2, the fourth channel 912 is for the positive electrode line 71 and the negative electrode line 72 to pass through, wherein the distal end of the electrode line is connected to a high-voltage plug, and the fifth channel 913 is communicated with the first channel 5;

[0065] Furthermore, the clamping arm device 10 comprises: a metal seat 11, and three clamping arms 12 fixedly disposed at the distal end of the metal seat 11;

[0066] The cross section of the metal seat 11 is hexagonal, the head end of the clamping arm 12 is a flat arc, each of the clamping arms 12 has two feet, and the legs of each of the clamping arms 12 are fixedly arranged at the vertex of each of the metal seats 11. The wire diameter of the head end of the clamping arm 12 is smaller than the wire diameter of the legs of the clamping arm 12. The outer surface of the clamping arm 12 is coated with a lubricating material. The axial length of the clamping arm 12 matches the axial length of the conical surface of the balloon 1, and the bending angle of the distal end of the clamping arm 12 matches the conical surface of the balloon 1. The angle of the shape matches the shape, and the clamping arm 12 is made of nickel-titanium memory alloy material; wherein, the outer surface of the three clamping arms is coated or covered with a lubricating material, which is conducive to reducing damage to the valve and better clamping the valve; the head ends of the three clamping arms are flat arcs and the wire diameter is smaller than the leg, and the lubricating material is coated on the outside, and the leg is fixed to the vertex of the metal seat 11 with a hexagonal cross-section, and the bending angle of the distal ends of the three clamping arms matches the angle of the conical surface of the balloon 1, and the axial length matches the axial length of the conical surface of the balloon. The synergistic effect of the three clamping arms and the balloon 1 can effectively clamp the calcified valve;

[0067] The distance between the head end of the clamping arm 12 and the distal end of the metal seat 11 is 1 cm, and the diameter of the fitting circle of the open size of the head ends of the three clamping arms 12 is 1.0 cm;

[0068] Wherein, the hemostatic valve 13 comprises: a first outlet channel 131 and a second outlet channel 132;

[0069] Wherein, a silicone sealing ring is fixedly arranged in the first outlet channel 131, and the proximal end of the intermediate tube 3 passes through the silicone sealing ring, and the silicone sealing ring is used to seal the second channel 6;

[0070] The second outlet channel 132 is connected to the second channel 6, and the side of the second outlet channel 132 away from the outer tube 4 penetrates the side wall of the main body. The second outlet channel 132 is fixedly connected to a three-way valve 133, and the three-way valve 133 can be used to introduce contrast agent or heparin;

[0071] Among them, the compressive strength of the silicone seal is 200psi;

[0072] The outer tube 4 is composed of a connecting section, a soft section, and a pushing section from the distal end to the proximal end;

[0073] The soft segment and the push segment are woven from braided wires, the hardness of the push segment is greater than the hardness of the soft segment, the hardness of the soft segment is 35D, and the length of the soft segment is 10 cm; wherein the soft segment has a hardness of 35D and a length of 10 cm and the push segment is woven from braided wires, the hardness of the push segment is greater than the hardness of the soft segment, and this design enables the catheter to be smoothly pushed in the blood vessel and adapt to the curvature and softness of the blood vessel, thereby reducing damage to the blood vessel wall;

[0074] The inner wall of the outer tube is coated with PTFE coating or lubricant, which reduces the friction of the middle tube relative to the outer tube when the middle tube and the button slide. When contrast agent is injected, the shear force between the contrast agent and the tube is reduced, and the contrast agent flow rate is increased. Or if blood enters the cavity, it is convenient for liquid flushing to prevent blood from clotting and adhering to the inner cavity.

[0075] The clamping arm 12 is made of nickel-titanium memory alloy material, and the intermediate tube 3 includes: a distal section and a proximal section. The distal section is a braided tube made of braided wire. The hardness of the distal section of the intermediate tube 3 is 50D. The proximal section of the intermediate tube 3 is a metal tube. The length of the proximal section is greater than the distance from the joint 91 to the sealing rubber ring of the three-way valve 133.

[0076] Wherein, the electrode assembly is in three groups;

[0077] The three groups of electrode assemblies are coaxially arranged, and the electrode assemblies include, from the inside to the outside, an inner electrode, an insulating tube, and an outer electrode; a plurality of discharge holes are provided on the insulating tube and the outer electrode, and the three groups of electrode assemblies are connected in series;

[0078] Among them, the inner electrode of the first electrode group 21 is connected to the negative electrode line 72, the outer electrode of the first electrode group 21 is connected to the outer electrode of the second electrode group 22, the inner electrode of the second electrode group 22 is connected to the inner electrode of the third electrode group 23, and the outer electrode of the third electrode group 23 is connected to the positive electrode line 71.

[0079] As a preferred embodiment, the material of the balloon 1 can be nylon and its derivatives, and the acoustic impedance of nylon and its derivatives is close to the optimal acoustic impedance of the liquid after the balloon is pressurized.

[0080] As a preferred embodiment, the distal end of the tip tube 8 has a chamfered cut with a certain taper, and the hardness of the tip of the tip tube is 30D.

[0081] Example 2

[0082] This embodiment provides a method for using a shock wave balloon device. Carefully load the valve shock wave device along the pre-implanted guide wire, and slowly push the shock wave catheter along the inner wall of the adjustable bending sheath until it reaches the top of the aortic valve. During the pushing process, pay attention to the structural characteristics of the outer tube 4. The connection section and the soft section have a hardness of 35D, a length of 10cm, and cooperate with the pushing section. The higher hardness of the pushing section facilitates pushing, and the moderate softness and specific length of the soft section can effectively adapt to the bending and soft characteristics of the blood vessel, reducing damage to the blood vessel wall;

[0083] The doctor holds and operates the sliding button 92 fixedly connected to the proximal end of the middle tube 3 on the handle 9, and drives the middle tube 3 through the sliding button 92 to push the balloon 1, and at the same time closely observes the mark of the balloon 1 by X-ray, and pushes the balloon 1 to the bottom of the valve, at which time the three clamping arms 12 of the clamping arm device 10 at the distal end of the outer tube 4 are fully released;

[0084] Then adjust the X-ray shooting angle to observe the positions of the three clamping arms and the movement of the valve. If the position of the clamping arms is found to be deviated, gently rotate the catheter to finely adjust the position of the clamping arms until they perfectly coincide with the three sinuses of the aorta to ensure that the clamping arms can act on the valve evenly and stably. Use ultrasound equipment to observe the movement of the aortic valve to further confirm the details of the valve and the relative position relationship between the device and the valve.

[0085] The contrast agent is filled into the balloon 1 through the first channel 5, providing an effective path for balloon filling and internal fluid circulation. When the balloon 1 is pressurized to a specified pressure, under real-time ultrasound observation, the sliding button 92 on the control handle 9 moves the balloon so that the valve is tightly clamped by the three clamping arms 12.

[0086] Then press the treatment button on the IVL connector cable to deliver 10 pulses within the pre-set time. At this time, the three sets of electrode assemblies in the inner tube 2 start working, and the electric arc breaks through the liquid in the balloon to generate shock waves. The shock waves are transmitted to the surface of the balloon 1 through the liquid to perform shock wave treatment on the calcified valve. After the pulse delivery is completed, the balloon 1 is completely retracted, and the adjustable sheath and guide wire are carefully withdrawn, thus completing the entire surgical process.

[0087] In summary, the present invention utilizes a balloon of a special shape, which is centered between the three leaflets. The balloon cooperates with a clamping arm of a special shape to make the valve stick to the balloon. The curvature of the balloon serves as a fulcrum, and the two feet of the clamping arm apply force in the direction of the fulcrum. While clamping the valve, it is easier to fracture the calcified valve. The centered balloon does not contact the valve ring, reducing the impact of shock wave energy on heart point conduction. The three clamping arms clamp the three valves to avoid the impact of heart beating on the surgical process. The three clamping arms clamp the three valves at the same time for shock wave therapy, thereby increasing surgical efficiency. During treatment, the device is provided with angiography channels above and below the valve, and no additional angiography catheter intervention is required, thereby reducing trauma to the patient and increasing the doctor's visualization operation.

[0088] The above description is only a preferred embodiment of the present invention, and does not limit the implementation mode and protection scope of the present invention. For those skilled in the art, it should be aware that all solutions obtained by equivalent substitutions and obvious changes made using the description and illustrations of the present invention should be included in the protection scope of the present invention.

Claims

1. A shock wave balloon device, characterized in that: include: A handle structure, and a balloon structure slidably arranged with the handle structure; wherein, The handle structure comprises: a handle (9) arranged at the proximal end, and an outer tube (4) fixedly arranged at the distal end of the handle (9); Wherein, a sliding button (92) is slidably provided on the handle (9), and the sliding button (92) is fixedly connected to the proximal end of the balloon structure; The balloon structure comprises: an intermediate tube (3) whose proximal end is fixedly connected to the sliding button (92), an inner tube (2) fixedly and coaxially sleeved inside the intermediate tube (3), a balloon (1) fixedly arranged at the distal end of the intermediate tube (3), and a tip tube (8) fixedly arranged at the distal end of the balloon (1); The intermediate tube (3) and the outer tube (4) are slidably matched, and the balloon (1) is sleeved on the outside of the inner tube (2).

2. A shock wave balloon device according to claim 1, characterized in that: The proximal end of the inner tube (2) penetrates the balloon (1), the middle tube (3) is coaxially sleeved on the outside of the inner tube (2), the outer tube (4) is coaxially sleeved on the outside of the middle tube (3), and the proximal end of the tip tube (8) is fixedly arranged on the distal end of the balloon (1). Wherein, a clamping arm device (10) is fixedly provided at the distal end of the outer tube (4), and a hemostatic valve (13) is fixedly provided at the proximal end of the outer tube (4); The distal end of the inner tube (2) is fixedly connected to the proximal end of the tip tube (8), and the tip tube (8) is coaxial with the inner tube (2); There is a first gap between the inner tube (2) and the middle tube (3), thereby forming a first channel (5), and there is a second gap between the middle tube (3) and the outer tube (4), thereby forming a second channel (6), and the first channel (5) is connected to the cavity in the balloon (1); The outer wall of the inner tube (2) is provided with two opposite outer cavities (7), a plurality of electrode assemblies are fixedly arranged in the inner tube (2), and the two opposite outer cavities (7) are respectively fixedly arranged with a positive electrode line (71) and a negative electrode line (72); The handle (9) comprises: a main body, a joint (91), and a sliding button (92); wherein the main body has a cavity inside, the hemostatic valve (13) is fixedly arranged in the main body, the joint (91) is slidably arranged at the proximal end of the main body, the proximal end of the joint passes through the proximal end of the main body, a groove is provided on one side of the main body, the sliding button (92) is slidably arranged in the groove, and one side of the sliding button (92) is fixedly arranged on the proximal outer wall of the intermediate tube (3); Wherein, the proximal ends of the intermediate tube (3) and the inner tube (2) are fixedly connected to the distal end of the joint (91).

3. A shock wave balloon device according to claim 2, characterized in that: The joint (91) comprises: a third channel (911), a fourth channel (912), and a fifth channel (913); wherein, The third channel (911), the fourth channel (912), and the fifth channel (913) pass through the main body; the third channel (911) is connected to the lumen (14) of the inner tube (2); the fourth channel (912) is used for the positive electrode line (71) and the negative electrode line (72) to pass through; and the fifth channel (912) is connected to the first channel (5).

4. A shock wave balloon device according to claim 2, characterized in that: The clamping arm device (10) comprises: a metal seat (11), and three clamping arms (12) fixedly arranged at the distal end of the metal seat (11); The cross section of the metal seat (11) is hexagonal, the head end of the clamping arm (12) is a flat arc, each of the clamping arms (12) has two feet, the leg of each clamping arm (12) is fixedly arranged at the vertex of each of the metal seats (11), the wire diameter of the head end of the clamping arm (12) is smaller than the wire diameter of the leg of the clamping arm (12), and the outer surface of the clamping arm (12) is coated or covered with a lubricating material; The distance between the head end of the clamping arm (12) and the distal end of the metal seat (11) is 1 cm to 3 cm, and the diameter of the fitting circle of the open size of the head ends of the three clamping arms (12) is 1.0 cm to 3.5 cm.

5. A shock wave balloon device according to claim 4, characterized in that: The balloon (1) is in the shape of an arc triangular pyramid, the angle of the cone of the cone surface of the balloon (1) is 28° to 60°, the axial lengths of the arc surface and the cone surface of the balloon (1) are equal, and the length of the cone surface of the balloon (1) is 1 cm to 5 cm.

6. A shock wave balloon device according to claim 5, characterized in that: The bending angle of the distal end of the clamping arm (12) matches the angle of the cone of the conical surface of the balloon (1), and the axial length of the clamping arm (12) matches the axial length of the conical surface of the balloon (1).

7. A shock wave balloon device according to claim 2, characterized in that: The hemostatic valve (13) comprises: a first outlet channel (131) and a second outlet channel (132); Wherein, a silicone sealing ring is fixedly arranged in the first outlet channel (131), the proximal end of the intermediate tube (3) passes through the silicone sealing ring, and the silicone sealing ring is used to seal the second channel (6); The second outlet channel (132) is in communication with the second channel (6); the side of the second outlet channel (132) away from the outer tube (4) penetrates the side wall of the main body; and the second outlet channel (132) is fixedly connected to a three-way valve (133); Among them, the compressive strength of the silicone sealing ring is 200psi to 500psi.

8. A shock wave balloon device according to claim 2, characterized in that: The outer tube (4) comprises a connecting section, a soft section and a pushing section from the distal end to the proximal end; The soft segment and the push segment are woven from braided wires. The hardness of the push segment is greater than that of the soft segment. The hardness of the soft segment is 35D to 55D. The length of the soft segment is 10cm to 35cm. The inner wall of the outer tube is coated with a PTFE coating or a lubricant.

9. A shock wave balloon device according to claim 3, characterized in that: The clamping arm (12) is made of nickel-titanium memory alloy material; The intermediate tube (3) comprises: a distal section and a proximal section; the distal section is a braided tube made of braided wire, the hardness of the distal section is 50D-70D, the proximal section of the intermediate tube (3) is a metal tube, and the length of the proximal section is greater than the distance from the joint (91) to the sealing rubber ring of the three-way valve (133).

10. The shock wave balloon device according to claim 1, characterized in that: The electrode assembly comprises three groups; The three groups of electrode assemblies are coaxially arranged, and the electrode assemblies include, from the inside to the outside, an inner electrode, an insulating tube, and an outer electrode; a plurality of discharge holes are provided on the insulating tube and the outer electrode, and the three groups of electrode assemblies are connected in series; The inner electrode of the first electrode group (21) is connected to the negative electrode line (72), the outer electrode of the first electrode group (21) is connected to the outer electrode of the second electrode group (22), the inner electrode of the second electrode group (22) is connected to the inner electrode of the third electrode group (23), and the outer electrode of the third electrode group (23) is connected to the positive electrode line (71).

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