A shockwave balloon device

Abstract

The application relates to the technical field of medical devices, in particular to an impact wave balloon device which comprises a handle structure and a balloon structure arranged in sliding mode with the handle structure; wherein the handle structure comprises a handle arranged at a proximal end and an outer tube fixedly arranged at a distal end of the handle; wherein a sliding button is arranged in sliding mode on the handle and fixedly connected with a proximal end of the balloon structure; the balloon structure comprises an intermediate tube fixedly connected with the sliding button at a proximal end, an inner tube fixedly coaxially sleeved on the inside of the intermediate tube, a balloon fixedly arranged at a distal end of the intermediate tube and a tip tube fixedly arranged at a distal end of the balloon; the special-shaped balloon is arranged in the middle of three leaflets, the balloon is matched with the special-shaped clamping arm, the trauma to the patient is reduced, and the visual operation of the doctor is improved.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and more particularly to a shockwave balloon device. Background Technology

[0002] Calcific aortic valve disease (CAVD), a common valvular heart disease, encompasses a range of conditions from aortic sclerosis to calcific aortic stenosis (AS). Aortic sclerosis is often a precursor to aortic stenosis, with approximately 9% of sclerotic aortic valve diseases progressing to stenosis within 5 years. Cardiovascular health studies show that about 1%-2% of sclerotic aortic valve diseases develop into stenosis each year, and 75% of these patients will require valve replacement surgery due to heart failure or die within 2-5 years. In calcific aortic stenosis, the leaflet stiffness gradually increases in the clinical pathogenesis, and the late-stage lesions resemble bone formation, with calcification as a prominent feature. Currently, transcatheter aortic valve implantation (TAVI) is the main treatment for calcific aortic stenosis, while drug therapy is still in the research and exploration stage.

[0003] Although artificial valves have been proven to have a certain degree of safety and effectiveness in clinical applications, the surgery is expensive and carries a risk of death (EuroSCORE ≥ 20%, STS ≥ 10%). In addition, artificial valves can recalcify and become ineffective over time after implantation. With the gradual promotion of the "mediation without implantation" concept, both doctors and patients hope for a low-risk, non-implantable device that can soften the valve and thus delay the implantation of artificial valves, rather than directly performing valve replacement surgery. They also hope to improve the valve function of calcified artificial valve prostheses.

[0004] In recent years, intravascular shockwave technology has been continuously developing. In the area of ​​intracoronary balloon shockwave lithotripsy, clinical research data from multiple companies both domestically and internationally have been published, fully demonstrating the safety and effectiveness of intravascular shockwave therapy for calcification. In the field of heart valves, the American Journal of Cardiovascular Angiography and Intervention (JSCAI) and the American College of Cardiology (JACC) reported cases of shockwave balloon-assisted treatment of mitral valve calcification. Cardiawave successfully verified the feasibility of ultrasound therapy for aortic calcification by treating 10 patients with extracorporeal ultrasound technology. Numerous international companies and institutions have conducted in-depth research on the cavitation effects of ultrasound and shockwave in treating valve calcification, showing that it can effectively soften calcified valves and biological tissues. Based on these research findings, this invention focuses on the application of shockwave cavitation effects, aiming to design a safe, convenient, and efficient device that applies shockwaves to calcified valves, inducing valve calcification and fracture, thereby softening the valve and meeting the urgent need in the current cardiovascular disease treatment field for low-risk, non-implantable treatment options. Summary of the Invention

[0005] The purpose of this invention is to address the shortcomings of existing technologies by providing a shockwave balloon device;

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

[0007] This invention provides a shockwave balloon device, comprising: a handle structure and a balloon structure slidably disposed with the handle structure; wherein,

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

[0009] 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 includes: a middle tube fixedly connected to the sliding button at its proximal end, an inner tube fixedly coaxially sleeved inside the middle tube, a balloon fixedly disposed at the distal end of the middle tube, and a tip tube fixedly disposed at the distal end of the balloon.

[0011] The intermediate tube and the outer tube are slidably fitted together, and the balloon is sleeved on the outside of the inner tube.

[0012] Furthermore, the distal end of the inner tube extends through the balloon, the intermediate tube is coaxially sleeved outside the inner tube, the outer tube is coaxially sleeved outside the intermediate tube, and the proximal end of the tip tube is fixedly disposed at the distal end of the balloon.

[0013] The distal end of the outer tube is fixedly provided with a clamping arm device, and the proximal end of the outer tube is fixedly provided with a hemostatic valve.

[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] The inner tube and the intermediate tube have a first gap, thereby forming a first channel; the intermediate tube and the outer tube have a second gap, thereby forming a second channel; and the first channel communicates with the cavity inside the balloon.

[0016] The inner tube has two opposing outer cavities on its outer wall. Several 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 opposing outer cavities, respectively.

[0017] The handle includes a main body, a connector, and a sliding button. The main body has an internal cavity, the hemostatic valve is fixedly disposed in the main body, the connector is slidably disposed at the proximal end of the main body, the proximal end of the connector passes through the proximal end of the main body, a groove is formed on one side of the main body, the sliding button is slidably disposed in the groove, and one side of the sliding button is fixedly disposed on the proximal outer wall of the intermediate tube.

[0018] The proximal ends of the intermediate tube and the inner tube are fixedly connected to the distal end of the connector.

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

[0020] The third, fourth, and fifth channels extend through the main body. The third channel is connected to the lumen of the inner tube. The fourth channel allows the positive and negative wires to pass through. The fifth channel is connected to the first channel.

[0021] Furthermore, the clamping arm device includes: a metal base, and three clamping arms fixedly disposed at the distal end of the metal base;

[0022] The metal base has a hexagonal cross-section, the head end of the clamping arm is a flat arc, each clamping arm has two legs, the legs of each clamping arm are fixedly disposed at each vertex of the metal base, the wire diameter of the head end of the clamping arm is smaller than the wire diameter of the legs 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 far end of the metal seat is 1cm to 3cm, and the diameter of the fitted circle of the opening size of the head ends of the three clamping arms is 1.0cm to 3.5cm.

[0024] Furthermore, the balloon is an arc-shaped triangular pyramid, the included angle of the cone surface of the balloon is 28°~60°, the axial length 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~5cm.

[0025] Furthermore, the bending angle of the distal end of the clamping arm matches the cone angle 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] Furthermore, the hemostatic valve includes: a first outlet channel and a second outlet channel;

[0027] A silicone sealing ring is fixedly provided in the first outlet channel, and the proximal end of the intermediate tube passes through the silicone sealing ring, which is used to seal the second channel.

[0028] The second outlet channel is connected to the second channel, and the side of the second outlet channel away from the outer tube passes through the side wall of the main body. A three-way valve is fixedly connected to the second outlet channel.

[0029] The silicone sealing ring has a pressure resistance of 200psi to 500psi.

[0030] Furthermore, the outer tube consists of a connecting section, a flexible section, and a pushing section, arranged sequentially from the distal end to the proximal end;

[0031] The soft segment and the pushing segment are woven from braided yarns. The hardness of the pushing segment is greater than that of the soft segment. The hardness of the soft segment is 35D~55D, and the length of the soft segment is 10cm~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 shape 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 yarn, and 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 connector to the sealing ring of the three-way valve. Further, the electrode assembly consists of three sets.

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

[0036] In this configuration, 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] This invention utilizes a specially shaped balloon, centrally positioned between the three valve leaflets. The balloon, in conjunction with specially shaped clamping arms, allows the valve to adhere to the balloon. The balloon's curvature serves as a fulcrum, with the two legs of the clamping arms applying force towards this fulcrum. This clamping action not only secures the valve but also facilitates fracture of calcified valves. The centrally positioned balloon avoids contact with the valve annulus, reducing the impact of shock wave energy on cardiac conduction. The three clamping arms clamp the three valves, preventing the heart's beating from affecting the surgical procedure. Simultaneous clamping of the three valves by the three arms for shock wave therapy increases surgical efficiency. During treatment, the device provides angiography channels above the valve (first channel) and below the valve (second channel), eliminating the need for additional angiography catheters, reducing patient trauma, and enhancing the surgeon's visualization. Attached Figure Description

[0039] Figure 1 This is a schematic diagram of the structure of the present invention;

[0040] Figure 2 This is an enlarged structural diagram of region A in this invention;

[0041] Figure 3 This is a schematic cross-sectional view of the inner tube in this invention;

[0042] Figure 4 This is a schematic diagram of the arc surface of the balloon in this invention;

[0043] Figure 5 This is a schematic diagram of the electrode assembly in this invention;

[0044] Figure 6 This is a schematic cross-sectional view of the outer tube, middle tube, and inner tube in this invention.

[0045] Figure 7 This is a schematic diagram of the clamping arm device in this invention;

[0046] The reference numerals in the attached figures are:

[0047] Handle, 9; Slide 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; External cavity, 7; Positive electrode wire, 71; Negative electrode 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 Implementation

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

[0049] Unless otherwise defined, the technical or scientific terms used in the claims and description shall have the ordinary meaning as understood by one of ordinary skill in the art to which this invention pertains.

[0050] The word "comprising" or similar terms used in the specification and claims of this patent application mean that the objects preceding "comprising" include the objects listed after "comprising" or their equivalents, and do not exclude other objects.

[0051] The numerical values ​​mentioned in this invention include all values ​​increasing one unit at a time from low to high, assuming that there is at least a two-unit interval between any lower and higher value. For example, if it is said that a component quantity or a physical quantity is better from 1 to 100, 10 to 90, and 20 to 80, it means that values ​​such as 5 to 95, 14 to 76, 23 to 67, 32 to 58, and 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 a suitable unit. The foregoing examples are for illustrative purposes only; in practice, all combinations of values ​​between the lowest and highest listed values ​​are considered to be clearly listed in this specification in a similar manner.

[0052] Example 1

[0053] This embodiment provides a shockwave balloon device, including: a handle structure and a balloon structure slidably disposed with the handle structure; wherein...

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

[0055] The handle 9 is slidably equipped with a sliding button 92, which is fixedly connected to the proximal end of the balloon structure. The handle 9, located at the proximal end, is convenient for doctors to hold and operate, while 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 precisely controlled by sliding the button 92.

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

[0057] The intermediate tube 3 and the outer tube 4 are slidably fitted together. 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. The tip tube 8 is coaxial with the inner tube 2. The balloon 1 is an arc-shaped triangular pyramid. The included angle of the cone of the balloon 1 is 28°. The axial length of the arc surface and the cone surface of the balloon 1 are equal. The length of the cone surface of the balloon 1 is 3 cm.

[0058] The distal end of the inner tube 2 extends through the balloon 1, the intermediate tube 3 is coaxially sleeved outside the inner tube 2, the outer tube 4 is coaxially sleeved outside the intermediate tube 3, and the proximal end of the tip tube 8 is fixedly disposed at the distal end of the balloon 1.

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

[0060] The inner tube 2 and the intermediate tube 3 have a first gap, thereby forming a first channel 5. The intermediate tube 3 and the outer tube 4 have a second gap, thereby forming a second channel 6. The first channel 5 communicates with the cavity inside the balloon 1. The balloon 1 is filled with contrast agent, and the contrast agent in the balloon 1 flows in through the first channel 5.

[0061] The inner tube 2 has two opposing outer cavities 7 on its outer wall. Several electrode assemblies are fixedly arranged in the inner tube 2. The two opposing outer cavities 7 are respectively fixedly arranged with a positive electrode line 71 and a negative electrode line 72.

[0062] The handle 9 includes a main body, a connector 91, and a sliding button 92. The main body has an internal cavity, and the hemostatic valve 13 is fixedly disposed in the main body. The connector 91 is slidably disposed at the proximal end of the main body, and the proximal end of the connector passes through the proximal end of the main body. A groove is formed on one side of the main body, and the sliding button 92 is slidably disposed in the groove. One side of the sliding button 92 is fixedly disposed 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 connector 91. When the sliding button 92 is pushed, the sliding button 92 drives the intermediate tube 3 to move, and the balloon 1 moves with the intermediate tube 3.

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

[0064] The third channel 911, the fourth channel 912, and the fifth channel 913 penetrate the main body. The third channel 911 is connected to the cavity 14 of the inner tube 2. The fourth channel 912 allows the positive electrode 71 and the negative electrode 72 to pass through, wherein the far end of the electrode wire is connected to a high-voltage plug. The fifth channel 913 is connected to the first channel 5.

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

[0066] The metal seat 11 has a hexagonal cross-section, and the clamping arms 12 have flattened arc ends. Each clamping arm 12 has two legs, which are fixedly positioned at each vertex of the metal seat 11. The wire diameter at the head end of the clamping arm 12 is smaller than the wire diameter at the legs. The outer surface of the clamping arm 12 is covered with a lubricating material. The axial length of the clamping arm 12 matches the axial length of the conical surface of the balloon 1. The bending angle of the distal end of the clamping arm 12 is related to the conical surface of the balloon 1. The cone-shaped included angles are matched, and the clamping arms 12 are made of nickel-titanium shape memory alloy. The structure design of coating or covering the outer surface of the three clamping arms with lubricating material helps to reduce damage to the valve and better clamp the valve. The head end of the three clamping arms is a flat arc with a wire diameter smaller than that of the legs, and is covered with lubricating material. The legs are fixed to the apex of the metal seat 11 with a hexagonal cross section. The bending angle of the distal end of the three clamping arms matches the included 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 from the head end of the clamping arm 12 to the far end of the metal base 11 is 1 cm, and the diameter of the fitted circle of the opening size of the head ends of the three clamping arms 12 is 1.0 cm.

[0068] The hemostatic valve 13 includes a first outlet channel 131 and a second outlet channel 132.

[0069] A silicone sealing ring is fixedly provided in the first outlet channel 131, and the proximal end of the intermediate tube 3 passes through the silicone sealing ring. 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. The side of the second outlet channel 132 away from the outer tube 4 passes through the side wall of the main body. The second outlet channel 132 is fixedly connected to a three-way valve 133, which can be used to introduce contrast agent or heparin.

[0071] The silicone sealing ring has a pressure resistance of 200 psi;

[0072] The outer tube 4 consists of a connecting section, a flexible section, and a pushing section from the distal end to the proximal end.

[0073] The flexible segment and the pushing segment are made of braided yarn. The pushing segment has a higher hardness than the flexible segment. The flexible segment has a hardness of 35D and a length of 10cm. The design of the flexible segment (35D hardness, 10cm length) and the pushing segment (made of braided yarn with a higher hardness than the flexible segment) allows the catheter to be smoothly pushed into the blood vessel while adapting to the curvature and flexibility of the vessel, reducing damage to the vessel wall.

[0074] The inner wall of the outer tube is coated with a PTFE coating or lubricant, which reduces the friction between the middle tube and the outer tube when the middle tube or button slides. Furthermore, it reduces the shear force between the contrast agent and the tubing during contrast agent injection, increasing the contrast agent flow rate. Alternatively, if blood enters the cavity, it facilitates fluid flushing and prevents blood from clotting and adhering to the inner lumen.

[0075] The clamping arm 12 is made of nickel-titanium shape memory alloy. 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 connector 91 to the sealing ring of the three-way valve 133.

[0076] The electrode assembly consists of three sets;

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

[0078] In this configuration, 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] In a preferred embodiment, the balloon 1 can be made of nylon or its derivatives, and the acoustic impedance of nylon or its derivatives is close to the acoustic impedance of the liquid after the balloon is pressurized.

[0080] In one preferred embodiment, the distal end of the tip tube 8 has a chamfered kerf 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 shockwave balloon device. The valve shockwave device is carefully loaded along a pre-implanted guidewire, and the shockwave catheter is slowly advanced along the inner wall of an adjustable curved sheath until it reaches above the aortic valve. During advancement, attention is paid to the structural characteristics of the outer tube 4. Its connecting section and flexible section have a hardness of 35D and a length of 10cm, working in conjunction with the advancement section. The higher hardness of the advancement section facilitates advancement, while the moderate flexibility and specific length of the flexible section effectively adapt to the curvature and flexibility of the blood vessel, reducing damage to the vessel wall.

[0083] The doctor holds the sliding button 92 fixed to the proximal end of the intermediate tube 3 on the handle 9 and pushes the balloon 1 by sliding the intermediate tube 3 through the sliding button 92. At the same time, the doctor closely observes the marker of the balloon 1 with X-ray and pushes the balloon 1 to below the valve. At this time, the three clamping arms 12 of the clamping arm device 10 at the distal end of the outer tube 4 will be fully released.

[0084] Then adjust the X-ray shooting angle to observe the position of the three clamping arms and the movement of the valve. If the position of the clamping arms is found to be deviated, the catheter can be gently rotated to finely adjust the position of the clamping arms until they perfectly coincide with the three sinuses of the aorta, ensuring 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 detailed condition of the valve and the relative positional 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 inflation and internal fluid circulation. When the balloon 1 is pressurized to the specified pressure, under real-time ultrasound observation, the balloon is moved by the sliding button 92 on the control handle 9, 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 preset time. At this time, the three sets of electrode components in the inner tube 2 start working, generating shock waves by puncturing the fluid inside the balloon through an electric arc. The shock waves are transmitted through the fluid to the surface of balloon 1 to perform shock wave therapy on the calcified valve. After the pulse delivery is completed, balloon 1 is completely retracted, and the adjustable bending sheath and guidewire are carefully withdrawn, thus completing the entire surgical procedure.

[0087] In summary, this invention utilizes a specially shaped balloon, centrally positioned between the three valve leaflets. The balloon, in conjunction with specially shaped clamping arms, allows the valve to adhere to the balloon. The balloon's curvature serves as a fulcrum, with the two legs of the clamping arms applying force towards this fulcrum. This clamping action not only secures the valve but also facilitates fracture of calcified valves. The centrally positioned balloon avoids contact with the valve annulus, reducing the impact of shock wave energy on cardiac conduction. The three clamping arms clamp the three valves, preventing the heart's beating from affecting the surgical procedure. Simultaneous clamping of the three valves by the three arms for shock wave therapy increases surgical efficiency. The device provides angiography channels above and below the valves during treatment, eliminating the need for additional angiography catheters, reducing patient trauma, and enhancing the surgeon's visualization.

[0088] The above description is merely a preferred embodiment of the present invention and does not limit the implementation and protection scope of the present invention. Those skilled in the art should realize that any equivalent substitutions and obvious changes made based on the description and illustrations of the present invention should be included within the protection scope of the present invention.

Claims

1. A shockwave balloon device, characterized in that, include: A handle structure and a balloon structure slidably disposed with the handle structure; The handle structure includes: a handle (9) disposed at the proximal end, and an outer tube (4) fixedly disposed at the distal end of the handle (9). A clamping arm device (10) is fixedly disposed at the distal end of the outer tube (4). The clamping arm device (10) includes a metal base (11) and three clamping arms (12) fixedly disposed at the distal end of the metal base (11). A sliding button (92) is slidably disposed on the handle (9), and the sliding button (92) is fixedly connected to the proximal end of the balloon structure. The balloon structure includes: a middle tube (3) whose proximal end is fixedly connected to the sliding button (92); an inner tube (2) fixedly and coaxially sleeved inside the middle tube (3); a balloon (1) fixedly disposed at the distal end of the middle tube (3); and a tip tube (8) fixedly disposed at the distal end of the balloon (1); the middle tube (3) and the outer tube (4) are slidably engaged, and the balloon (1) is sleeved outside the inner tube (2); The balloon (1) is a circular arc triangular pyramid shape. The bending angle of the distal end of the clamping arm (12) matches the cone angle of the conical surface of the balloon (1). The axial length of the clamping arm (12) matches the axial length of the conical surface of the balloon (1). The three clamping arms (12) work together with the balloon (1) to effectively clamp the calcified valve.

2. The shockwave balloon device according to claim 1, characterized in that, The distal end of the inner tube (2) penetrates the balloon (1), the intermediate 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 intermediate tube (3), and the proximal end of the tip tube (8) is fixedly disposed at the distal end of the balloon (1). Among them, 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). The first channel (5) is connected to the cavity inside the balloon (1). The inner tube (2) has two opposing outer cavities (7) on its outer wall. Several electrode assemblies are fixedly arranged in the inner tube (2). The two opposing outer cavities (7) are respectively fixedly arranged with a positive electrode line (71) and a negative electrode line (72). The handle (9) includes a main body, a connector (91), and a sliding button (92); the main body has an internal cavity, the hemostatic valve (13) is fixedly disposed in the main body, the connector (91) is slidably disposed at the proximal end of the main body, the proximal end of the connector 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 disposed in the groove, and one side of the sliding button (92) is fixedly disposed 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 connector (91).

3. The shockwave balloon device according to claim 2, characterized in that, The connector (91) includes: 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) penetrate the main body. The third channel (911) is connected to the lumen (14) of the inner tube (2). The fourth channel (912) allows the positive electrode line (71) and the negative electrode line (72) to pass through. The fifth channel (913) is connected to the first channel (5).

4. The shockwave balloon device according to claim 1, characterized in that, The metal base (11) has a hexagonal cross-section, and the head end of the clamping arm (12) is a flat arc. Each clamping arm (12) has two legs. The legs of each clamping arm (12) are fixedly disposed at each vertex of the metal base (11). The wire diameter at 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 or covered with a lubricating material.

5. The shockwave balloon device according to claim 4, characterized in that, The distance between the head end of the clamping arm (12) and the far end of the metal seat (11) is 1cm to 3cm, and the diameter of the fitted circle of the opening size of the head ends of the three clamping arms (12) is 1.0cm to 3.5cm.

6. The shockwave balloon device according to claim 5, characterized in that, The included angle of the cone shape of the conical surface of the balloon (1) is 28°~60°, the axial length of the arc surface of the balloon (1) is equal to that of the cone surface, and the length of the cone surface of the balloon (1) is 1cm~5cm.

7. The shockwave balloon device according to claim 2, characterized in that, The hemostatic valve (13) includes: a first outlet channel (131) and a second outlet channel (132); A silicone sealing ring is fixedly provided in the first outlet channel (131), and the proximal end of the intermediate tube (3) passes through the silicone sealing ring. The silicone sealing ring is used to seal the second channel (6). 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) passes through the side wall of the main body. The second outlet channel (132) is fixedly connected to a three-way valve (133). The silicone sealing ring has a pressure resistance of 200psi to 500psi.

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

9. A shockwave balloon device according to claim 7, characterized in that, The clamping arm (12) is made of nickel-titanium shape memory alloy material; The intermediate tube (3) includes a distal section and a proximal section; the distal section is a braided tube made of braided yarn, 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 connector (91) to the sealing ring of the three-way valve (133).

10. A shockwave balloon device according to claim 2, characterized in that, The electrode assembly consists of three sets; The three sets of electrode assemblies are coaxially arranged, and the electrode assembly includes, from the inside to the outside, an inner electrode, an insulating tube, and an outer electrode; the insulating tube and the outer electrode are provided with a plurality of discharge holes, and the three sets 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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