Shock wave balloon catheter and shock wave generating device

Abstract

The utility model discloses a shock wave balloon catheter and shock wave generating device, the shock wave balloon catheter comprises a balloon and a catheter main body, the balloon is connected with the catheter main body, the shock wave balloon catheter also comprises an electrode assembly used for generating shock wave, the electrode assembly is connected with the catheter main body, and the electrode assembly is connected with the catheter main body. And the balloon is a high-pressure non-compliant balloon and is positioned in the balloon. By means of the high-pressure non-compliance shock wave balloon, the treatment effect of high-pressure expansion lumen modification capacity and shock wave emission capacity can be achieved in lumen stenosis caused by vascular calcification, insufficient stent expansion caused by calcification or stent restenosis lesion, the use amount of instruments in an operation can be reduced, and the treatment cost is reduced. Operation time is shortened, and operation efficiency is improved.

Description

Technical Field

[0001] The utility model relates to the technical field of medical equipment, in particular to a shock wave balloon catheter and a shock wave generating device. Background Art

[0002] At present, the recommended treatment for in-stent restenosis after insufficient stent expansion caused by vascular calcification mainly includes shock wave balloon catheter. The existing shock wave balloon catheter consists of components such as balloon, inner tube, outer tube, shock wave generator, etc. Its balloon is a low-pressure semi-compliant balloon with a treatment pressure of 4atm, a nominal pressure and post-treatment pressure of 6atm, and a rated burst pressure of 10atm. However, in vascular calcification and insufficient stent expansion caused by it, in-stent restenosis, and other lesions that require simultaneous treatment with shock waves and high-pressure non-compliant balloons, a single low-pressure semi-compliant shock wave balloon cannot complete the lumen modification of the diseased blood vessels before and after pulse energy treatment. Good lesion lumen modification often requires high-pressure non-compliant balloons to perform high-pressure expansion to reconstruct the overall morphology of the plaque tissue. The balloon pressure during the expansion and reconstruction process often needs to be increased to 18-20atm, which far exceeds the pressure range of low-pressure semi-compliant shock wave balloons. Therefore, the current low-pressure semi-compliant shock wave balloon has limited expansion capacity and weak high-pressure resistance, and cannot meet the requirements for lumen modification of diseased blood vessels. Utility Model Content

[0003] The embodiments of the utility model provide a shock wave balloon catheter and a shock wave generating device, which are intended to solve the problem that the existing low-pressure semi-compliant shock wave balloon has limited expansion capability and cannot meet the requirements for lumen modification of diseased blood vessels.

[0004] The utility model provides a shock wave balloon catheter, comprising a balloon and a catheter body, wherein the balloon is connected to the catheter body, and the shock wave balloon catheter further comprises: an electrode assembly for generating shock waves, wherein the electrode assembly is connected to the catheter body and is located in the balloon, and the balloon is a high-pressure non-compliant balloon.

[0005] In the shock wave balloon catheter provided by the utility model, the high-pressure non-compliant balloon is a single-layer balloon, and the single-layer balloon is made of a combination of one or more of nylon, polyethylene terephthalate and polyethylene.

[0006] In the shock wave balloon catheter provided by the utility model, the high-pressure non-compliant balloon is a single-layer balloon, and the single-layer balloon is made of a combination of one or more of nylon, polyethylene terephthalate and polyethylene.

[0007] In the shock wave balloon catheter provided by the utility model, the high-pressure non-compliant balloon is a double-layer balloon, which includes an inner balloon and an outer balloon. The inner balloon is made of a combination of one or more of nylon, polyethylene terephthalate and polyethylene, and the outer balloon is made of a combination of one or more of thermoplastic polyurethane rubber, polyurethane resin and polyether amide block copolymer.

[0008] In the shock wave balloon catheter provided by the utility model, the high-pressure non-compliant balloon is a double-layer balloon, which includes an inner balloon and an outer balloon, the inner layer is made of a combination of one or more of thermoplastic polyurethane rubber, polyurethane resin, and polyetheramide block copolymer, and the outer balloon is made of a combination of one or more of nylon, polyethylene terephthalate, and polyethylene.

[0009] In the shock wave balloon catheter provided by the utility model, when the high-pressure non-compliant balloon is inflated to a nominal pressure value, the deformation rate of the high-pressure non-compliant balloon reaches a critical value.

[0010] In the shock wave balloon catheter provided by the utility model, the length of the high-pressure non-compliant balloon ranges from 5 to 50 mm.

[0011] In the shock wave balloon catheter provided by the utility model, the diameter of the high-pressure non-compliant balloon ranges from 1.5 to 10 mm.

[0012] In the shock wave balloon catheter provided by the utility model, the deformation amount of the high-pressure non-compliant balloon is not higher than 6%.

[0013] In the shock wave balloon catheter provided by the utility model, the nominal pressure range of the high-pressure non-compliant balloon is 10-30 atm.

[0014] In the shock wave balloon catheter provided by the utility model, the catheter body includes an inner tube and an outer tube, an inflation and relief cavity of the balloon is formed between the inner tube and the outer tube, the proximal end of the balloon is connected to the distal end of the outer tube, and the distal end of the balloon is connected to the distal end of the inner tube.

[0015] In the shock wave balloon catheter provided by the utility model, the shock wave balloon catheter further comprises an operating part, and the operating part is connected to the proximal end of the outer tube.

[0016] In the shock wave balloon catheter provided by the utility model, the electrode assembly includes: an inner electrode, an outer electrode and an insulating member, the inner electrode is attached to the outer wall of the inner tube, the outer electrode is arranged on the outer periphery of the inner electrode, and the insulating member is arranged between the inner electrode and the outer electrode.

[0017] The utility model also provides a shock wave generating device, comprising: a shock wave balloon catheter and a shock wave transmitter, wherein the shock wave balloon catheter is the above-mentioned shock wave balloon catheter, and the shock wave transmitter is electrically connected to the electrode assembly of the shock wave balloon catheter.

[0018] The utility model provides a shock wave balloon catheter and a shock wave generating device. The shock wave balloon catheter comprises a balloon, a catheter body and an electrode assembly. The balloon is connected to the catheter body. The electrode assembly is arranged on the catheter body and located in the balloon. The electrode assembly is used to generate shock waves. The balloon is a high-pressure non-compliant balloon. Therefore, it has both the expansion ability of a high-pressure balloon and the energy emission ability of a shock wave balloon, can realize lumen modification, expand the application range of the balloon, improve surgical efficiency, reduce medical consumption, and reduce treatment risks. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] In order to more clearly illustrate the technical solutions of the embodiments of the utility model, the drawings required for use in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are some embodiments of the utility model. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0020] Figure 1 This is a schematic diagram of a shock wave generating device according to an embodiment of the utility model;

[0021] Figure 2 A schematic diagram of the relationship between the pressure and deformation rate of the balloon in an embodiment of the utility model;

[0022] Reference numerals:

[0023] 1. Balloon; 2. Inner tube; 3. Outer tube; 4. Electrode assembly; 5. Operating unit; 6. Shock wave transmitter. DETAILED DESCRIPTION

[0024] The following will be combined with the drawings in the embodiments of the utility model to clearly and completely describe the technical solutions in the embodiments of the utility model. Obviously, the described embodiments are part of the embodiments of the utility model, not all of the embodiments. Based on the embodiments of the utility model, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the utility model.

[0025] The directional terms mentioned in the present invention, such as "upper", "lower", "front", "back", "left", "right", "inner", "outer", "side", etc., are only for reference to the directions of the attached drawings. Therefore, the directional terms used are used to illustrate and understand the present invention, but not to limit the present invention. In addition, in the drawings, structures with similar or identical structures are represented by the same reference numerals.

[0026] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include one or more of the features. In the description of the present utility model, the meaning of "plurality" is two or more, unless otherwise clearly and specifically defined.

[0027] In order to facilitate understanding of the shock wave balloon catheter of this embodiment, the relevant medical background of the shock wave balloon catheter is further introduced below.

[0028] Coronary heart disease is the leading cause of death and disability in many countries. Percutaneous coronary intervention (PCI) has become an effective means of treating coronary artery stenosis. The earliest and most mature one is percutaneous coronary stent implantation. After years of development, the rapid development of stent bioengineering technology has improved the safety and effectiveness of stent treatment. With the continuous development of PCI, interventional treatment involves more complex lesions. Coronary artery calcification lesions often run through various complex lesions, which increases the difficulty of coronary artery interventional treatment and is one of the main challenges faced by cardiovascular interventional physicians. In particular, severe calcified lesions, or severely calcified lesions with distortion, angulation, and diffuseness, significantly increase the incidence of immediate surgical complications and early and late major adverse cardiovascular events. In-stent restenosis (ISR) is the main group of restenosis after PCI and is an important burden of PCI treatment. ISR refers to the phenomenon that after the implantation of a stent at the target vascular lesion site, pathological processes such as neointimal tissue hyperplasia and new atherosclerosis occur, leading to restenosis of the vascular lumen. It usually occurs 6-12 months after PCI. ISR may also lead to the recurrence of major adverse cardiovascular events (MACE), including angina pectoris, acute myocardial infarction, and even sudden cardiac death, greatly limiting the clinical safety and effectiveness of PCI. The mechanism of ISR is multifactorial, including mechanical factors, biological factors, patient factors, and operator factors. Among them, calcified lesions are closely related to the formation of higher intra-stent thrombosis and target lesion revascularization, which may lead to insufficient stent expansion and poor stent adhesion leading to stent failure, and are one of the main causes of ISR.

[0029] At present, the recommended treatment for vascular calcification and in-stent restenosis after insufficient stent expansion is mainly shock wave balloon. As a new technology, this system mainly draws on the extracorporeal lithotripsy of urology. The working principle is different from the traditional treatment technology of calcified lesions. By perfectly combining the sonic calcification fracturing technology with the balloon catheter, it can provide unfocused, circumferential and pulsed mechanical energy to the lesion during balloon expansion to efficiently and safely destroy superficial and deep calcification, thereby significantly improving vascular compliance. This unique mechanism of action makes the device effective not only for superficial calcification and deep calcification, but also for eccentric lesions and non-eccentric lesions. It is simple to use and has almost no learning curve.

[0030] When using shock wave balloons for clinical work, the shock wave balloon should first be delivered to the site of calcified lesions with the help of a balloon catheter platform, and the balloon should be pressurized by a pressure pump to ensure close contact with the blood vessel wall; then the lithotripsy transmitter at the tip of the balloon catheter is activated to intermittently emit pulses, thereby forming a short burst of acoustic pressure waves. The acoustic pressure wave passes through the coronary artery tissue, impacting and destroying the calcified lesions with effective pressure, and eventually the multiple transmitters installed on the balloon catheter can produce an acoustic circumferential field effect in the blood vessel, resulting in calcified ruptures of the intima and media. Once 10 pulses are completed per cycle, the balloon can increase the pressure to 6atm (standard atmospheric pressure) to increase the compliance of the balloon, so that the modification effect of the calcified lesions can be judged by evaluating the symmetrical expansion of the balloon.

[0031] After fully understanding the relevant medical background of shock wave balloon catheters, the technical background of existing shock wave balloon catheters will be further explained.

[0032] The existing shock wave balloon catheter is composed of components such as a balloon, an inner tube, an outer tube, and a shock wave generating device. The balloon is a low-pressure semi-compliant balloon with a treatment pressure of 4 atm, a nominal pressure and a post-treatment pressure of 6 atm, and a rated burst pressure of 10 atm. However, in vascular calcification and the insufficient stent expansion or in-stent restenosis caused by it, and other lesions that require simultaneous treatment with shock waves and high-pressure non-compliant balloons, a single low-pressure semi-compliant shock wave balloon cannot complete the lumen modification of the diseased blood vessels before and after pulse energy treatment. Good lesion lumen modification often requires high-pressure non-compliant balloons to perform high-pressure expansion to reconstruct the overall morphology of the plaque tissue. The balloon pressure during the expansion and reconstruction process often needs to be increased to 18-20 atm, which far exceeds the pressure range of the low-pressure semi-compliant shock wave balloon. The differences between existing semi-compliant balloons and non-compliant balloons are shown in Table 1.

[0033]

[0034] Table 1

[0035] Therefore, the following problems exist in the current treatment of vascular calcification and its resulting insufficient stent expansion or in-stent restenosis and other lesions that require simultaneous treatment with shock waves and high-pressure non-compliant balloons:

[0036] The current shock wave balloons are low-pressure semi-compliant balloons with single functions, and are unable to modify the lumen in lesions such as vascular calcification and in-stent restenosis caused by insufficient stent expansion. After using the shock wave balloon to lyse the calcification, the surgeon needs to use a high-pressure non-compliant balloon to modify the lumen. During the operation, the surgeon needs to alternate between the high-pressure non-compliant balloon and the shock wave balloon. This alternating use requires repeatedly moving different balloons in and out of the patient's coronary artery along the working guidewire, which seriously prolongs the duration of the entire PCI operation, while increasing the surgical risk and the surgeon's workload, wasting medical resources to a certain extent.

[0037] Easy to rupture, high risk. The current shock wave balloon is made of a relatively soft material. Since it acts on the calcified area of ​​the blood vessels, there is a great risk of the balloon rupture. At the same time, data from the adverse event database also show that the balloon rupture rate in clinical practice is relatively high, especially when the balloon ruptures accidentally when the shock wave releases energy, which can cause unpredictable damage to the blood vessels and the patient, and there is a high risk.

[0038] Medical consumption is high. The current shock wave balloon also requires the use of other pre-dilation balloons, post-dilation balloons, etc., which consumes too many balloon consumables and increases the medical burden.

[0039] To this end, the embodiments of the present invention provide a shock wave balloon catheter and a shock wave generating device to solve the problem that the existing low-pressure semi-compliant shock wave balloon has limited expansion capacity and cannot meet the requirements of lumen modification of diseased blood vessels. By providing a high-pressure non-compliant shock wave balloon, it has both the expansion capacity of the high-pressure balloon and the energy emission capacity of the shock wave balloon, thereby expanding the scope of application of the balloon, improving surgical efficiency, reducing medical consumption, and lowering treatment risks.

[0040] The embodiment of the present invention is to solve the above problem that lumen modification cannot be achieved, and its technical solution is as follows:

[0041] The specific solution is to improve the low-pressure semi-compliant shock wave balloon catheter into a high-pressure non-compliant shock wave balloon catheter. Compared with the existing low-pressure semi-compliant shock wave balloon and high-pressure non-compliant balloon, this solution combines the advantages of both. On the one hand, a high-pressure non-compliant balloon is used to enable it to have the expansion ability of a high-pressure balloon. On the other hand, an electrode assembly is used to generate shock waves, which enables it to have energy emission capabilities. Therefore, this solution proposes a high-pressure non-compliant shock wave balloon, which has both the expansion ability of a high-pressure balloon and the energy emission ability of a shock wave balloon. It can perform lumen modification in lesions such as vascular calcification and in-stent restenosis caused by insufficient stent expansion. There is no need to use additional high-pressure non-compliant balloons or other pre-expansion balloons, which shortens the operation time, reduces the risk of surgery, improves the efficiency of surgery, reduces medical consumables, and reduces the medical burden. At the same time, the material of the high-pressure non-compliant balloon is harder and has strong pressure resistance, making it more resistant to puncture, greatly reducing the balloon rupture rate and improving the safety of use.

[0042] In order to better understand the above technical solution, the above technical solution will be described in detail below in conjunction with the accompanying drawings and specific implementation methods.

[0043] Reference Figure 1 The utility model embodiment provides a shock wave balloon catheter, comprising a balloon 1 and a catheter body, wherein the balloon 1 is connected to the catheter body, and the shock wave balloon catheter further comprises: an electrode assembly 4 for generating shock waves, wherein the electrode assembly 4 is connected to the catheter body and is located in the balloon 1, and the balloon 1 is a high-pressure non-compliant balloon 1. The high-pressure non-compliant balloon 1 can be a balloon made of a high-pressure non-compliant material.

[0044] Specifically, the catheter body is in the shape of a long strip as a whole, one end of the catheter body is connected to the balloon 1, and the other end is connected to the operating part 5 for the doctor to operate. An electrode assembly 4 is arranged on one end of the catheter body, and the balloon 1 wraps the electrode assembly 4. The balloon 1 is filled with a conductive liquid, which can be a contrast agent. The conductive liquid is used to conduct shock waves, and the contrast agent can also help the doctor locate the lesion. In the specific operation, a pressure charging and relief cavity is arranged on the catheter body, and the entrance of the pressure charging and relief cavity is arranged on the early operating part 5. A syringe is used to inject the conductive liquid into the liquid channel through the entrance of the pressure charging and relief cavity on the operating part 5, and enter the balloon 1 through the pressure charging and relief cavity. The operating part 5 is connected to the shock wave transmitter 6 through a power cord. The shock wave transmitter is used to provide a voltage / current pulse to the electrode assembly 4. After applying the pulse high voltage, the electrode assembly 4 discharges, and the arc breaks through the contrast liquid between the electrode assemblies 4, causing it to gasify and expand to generate shock waves, thereby calcifying the lesion. Then, by utilizing the characteristics of the high-pressure non-compliant balloon 1 that it can withstand higher pressures while not undergoing significant deformation, the balloon 1 deforms after being pressurized to reshape the morphology of the diseased blood vessel, thereby achieving lumen modification of the diseased blood vessel.

[0045] Through this embodiment, a high-pressure non-compliant shock wave balloon 1 is provided, which has both the expansion ability of the high-pressure balloon 1 and the energy emission ability of the shock wave balloon 1. It can not only partially lyse the calcification of calcified lesions, but also expand the blood vessels to complete lumen modification, thereby expanding the application scope of the balloon 1, improving surgical efficiency, reducing medical consumption, and reducing treatment risks.

[0046] Continue to refer to Figure 1In this embodiment, the catheter body includes an inner tube 2 and an outer tube 3, and a pressure-inflating and decompression cavity of the balloon 1 is formed between the inner tube 2 and the outer tube 3. The proximal end of the balloon 1 is connected to the distal end of the outer tube 3, and the distal end of the balloon 1 is connected to the distal end of the inner tube 2. Specifically, the end of the outer tube 3 close to the operating part 5 is the proximal end of the outer tube 3, and the end of the outer tube 3 away from the operating part 5 is the distal end of the outer tube 3. The end of the inner tube 2 close to the operating part 5 is the proximal end of the inner tube 2, and the end of the inner tube 2 away from the operating part 5 is the distal end of the inner tube 2. The end of the balloon 1 close to the operating part 5 is the proximal end of the balloon 1, and the end of the balloon 1 away from the operating part 5 is the distal end of the balloon 1. The proximal end of the outer tube 3 is connected to the operating part 5, the distal end of the inner tube 2 exceeds the distal end of the outer tube 3, the electrode assembly 4 is arranged at the part of the distal end of the inner tube 2 that exceeds the distal end of the outer tube 3, the proximal end of the balloon 1 is connected to the distal end of the outer tube 3, the distal end of the balloon 1 is connected to the distal end of the inner tube 2, and the balloon 1 wraps the electrode assembly 4. The outer tube 3 is sleeved on the outside of the inner tube 2, and a pressure filling and relief cavity of the balloon 1 is formed between the outer tube 3 and the inner tube 2. The balloon 1 is filled with conductive liquid through the pressure filling and relief cavity. The balloon 1 expands and adheres to the blood vessel wall under the filling of the conductive liquid. When the treatment is completed, the conductive liquid in the balloon 1 also flows out through the pressure filling and relief cavity to relieve the pressure of the balloon 1. Through the structure of the catheter body of this embodiment, the balloon 1, the inner tube 2 and the outer tube 3 form a relatively sealed area with only one channel to the outside world.

[0047] Furthermore, the shock wave balloon catheter also includes an operating part 5, which is connected to the proximal end of the outer tube 3. The operating part 5 of this embodiment is a handle, which can be set to a shape that is convenient for the doctor to hold, such as a cylindrical structure, and the outer periphery of the handle can also be provided with anti-skid patterns to increase friction and avoid slipping. The handle is connected to the outer tube 3 by spiral tightening or snapping. The end of the handle away from the outer tube 3 is also connected to a power cord for connecting the shock wave transmitter 6.

[0048] In this embodiment, the electrode assembly 4 includes: an inner electrode (not shown in the figure), an outer electrode (not shown in the figure) and an insulating member (not shown in the figure), the inner electrode is attached to the outer wall of the inner tube 2, the outer electrode is arranged on the outer periphery of the inner electrode, and the insulating member is arranged between the inner electrode and the outer electrode.

[0049] Specifically, the mechanism of action of shock wave therapy is based on the hydrostatic effect generated by the discharge of electrodes in a liquid medium. During the discharge of electrodes, the large current passing through the liquid medium can vaporize the surrounding liquid to form bubbles that expand rapidly outward, and then shrink in volume in a very short time, producing a cavitation effect. During the rapid expansion and rupture of the bubbles, since the particle movement speed exceeds the speed of sound in the medium, a powerful shock wave is generated. This phenomenon is also called the hydrostatic effect. The shock wave generated by the hydrostatic effect is used to impact the calcified area of ​​the lesion to break or loosen the calcified tissue, thereby expanding the diameter of the blood vessels and achieving a therapeutic effect.

[0050] The electrode assembly 4 in this embodiment has a three-layer structure, which includes, from the inside to the outside, an inner electrode fitted to the outer wall of the inner tube 2, an insulating member, and an outer electrode on the outermost layer. The insulating member may be an insulating sleeve. The gap between the inner and outer electrodes may be adjusted by the insulating sleeve. During operation, the electric arc penetrates the contrast fluid between the inner and outer electrodes, causing it to vaporize and expand to generate a shock wave.

[0051] The conventional non-compliant balloon 1 is usually made of nylon. In order to further improve the puncture resistance and working pressure of the balloon 1, the material of the balloon 1 is optimized in this embodiment. Several preferred implementations are provided below.

[0052] In one embodiment, the high-pressure non-compliant balloon 1 is a single-layer balloon 1, and the single-layer balloon 1 is made of a combination of one or more of nylon, polyethylene terephthalate and polyethylene.

[0053] In one embodiment, the high-pressure non-compliant balloon 1 is a double-layer balloon 1, and the double-layer balloon 1 includes an inner layer balloon 1 and an outer layer balloon 1, the inner layer balloon 1 is made of a combination of one or more of nylon, polyethylene terephthalate and polyethylene, and the outer layer is made of a combination of one or more of thermoplastic polyurethane rubber, polyurethane resin, and polyether amide block copolymer.

[0054] In one embodiment, the high-pressure non-compliant balloon 1 is a double-layer balloon 1, and the double-layer balloon 1 includes an inner layer balloon 1 and an outer layer balloon 1, the inner layer is made of a combination of one or more of thermoplastic polyurethane rubber, polyurethane resin, and polyetheramide block copolymer, and the outer layer balloon 1 is made of a combination of one or more of nylon, polyethylene terephthalate, and polyethylene.

[0055] The above-mentioned embodiment optimizes the material of the balloon 1 to make it more puncture-resistant, greatly reduce the rupture rate, and improve the safety of use.

[0056] In one embodiment, when the high-pressure non-compliant balloon 1 is pressurized to a nominal pressure value, the deformation rate of the high-pressure non-compliant balloon 1 reaches a critical value. Specifically, in the manufacturing process of the balloon 1, by controlling the size of the balloon 1 mold, especially the radial size of the mold, and the specific proportional relationship with the nominal diameter, when the balloon 1 is pressurized to the nominal pressure value after the balloon 1 is manufactured, the deformation rate of the balloon 1 material reaches a critical value, so that when the balloon 1 is subjected to a larger pressure value, its deformation changes non-obvious with the change of the pressure value, and has the characteristics of a non-compliant balloon 1. Specifically, assuming that the nominal diameter of the balloon 1 is D1 (not shown in the figure), the radial diameter of the mold for making the balloon 1 is D2 (not shown in the figure), and D1 and D2 satisfy a preset proportional relationship. The preset proportional relationship is set by those skilled in the art according to actual needs and is not limited here. By controlling the above-mentioned proportional relationship, the balloon 1 has the characteristics of a non-compliant balloon 1. As Figure 2 As shown, the balloon 1 is filled with conductive liquid. As the filling pressure increases in the working range, the deformation rate of the balloon 1 also increases. However, when the pressure of the balloon 1 reaches a critical value, even if the pressure continues to increase, the deformation rate of the balloon 1 will not increase, but will be relatively flat, without significant changes, and the balloon 1 will not continue to expand. The high-pressure resistance is strong, the rated bursting pressure of the balloon 1 is increased, and the probability of the balloon 1 rupturing during surgery is greatly reduced.

[0057] By optimizing the material tube for making the balloon 1 as described above, the working pressure of the balloon 1 is increased by utilizing the manufacturing process of the single-layer mixed material balloon 1 or the double-layer balloon 1, and combined with the optimization of controlling the balloon 1 mold and the balloon 1 molding process as described above, a high-pressure non-compliant balloon 1 is manufactured.

[0058] The high-pressure non-compliant balloon 1 manufactured by this embodiment has the following shape characteristics, which are as follows:

[0059] In one embodiment, the length of the high pressure non-compliant balloon 1 ranges from 5 to 50 mm. Exemplarily, the length of the high pressure non-compliant balloon 1 is 5 mm. Exemplarily, the length of the high pressure non-compliant balloon 1 is 50 mm. Exemplarily, the length of the high pressure non-compliant balloon 1 is 25 mm.

[0060] In one embodiment, the diameter of the high pressure non-compliant balloon 1 ranges from 1.5 to 10 mm. Exemplarily, the diameter of the high pressure non-compliant balloon 1 is 1.5 mm. Exemplarily, the diameter of the high pressure non-compliant balloon 1 is 10 mm. Exemplarily, the diameter of the high pressure non-compliant balloon 1 is 5 mm.

[0061] In one embodiment, the deformation amount of the high-pressure non-compliant balloon 1 is not higher than 6%. Specifically, the deformation amount of this embodiment refers to the diameter change of the balloon 1 before and after filling. For example, after the balloon 1 is filled, the diameter of the balloon 1 increases by 6%. Exemplarily, the deformation amount of the high-pressure non-compliant balloon 1 is not higher than 6%, that is, the maximum deformation amount is 6%. Exemplarily, the maximum deformation amount of the high-pressure non-compliant balloon 1 is 5%.

[0062] In one embodiment, the nominal pressure range of the high-pressure non-compliant balloon 1 is 10-30atm. Exemplarily, the nominal pressure of the high-pressure non-compliant balloon 1 is 10atm. Exemplarily, the nominal pressure of the high-pressure non-compliant balloon 1 is 30atm. Exemplarily, the nominal pressure of the high-pressure non-compliant balloon 1 is 20atm. The high-pressure non-compliant balloon 1 of this embodiment can withstand a pressure of at least 40atm without rupture.

[0063] The present utility model embodiment also provides a shock wave generating device, comprising: a shock wave balloon catheter and a shock wave transmitter 6, wherein the shock wave balloon catheter is the shock wave balloon catheter mentioned above, and the shock wave transmitter 6 is electrically connected to the electrode assembly 4 of the shock wave balloon catheter. The shock wave balloon catheter has been described in detail in the above embodiment, and for the sake of brevity of the specification, it will not be repeated here.

[0064] Specifically, the shock wave transmitter 6 of this embodiment mainly provides high voltage pulses to the electrode assembly 4. The electrical connection structure between the shock wave transmitter 6 and the electrode assembly 4 can be a wire or other structure, which is not limited here.

[0065] In order to further illustrate the working principle of the shock wave generating device of this embodiment, the following is an explanation of the surgical process using the shock wave generating device:

[0066] The working process is as follows: after the patient's chest is opened by means of surgery, an incision is made on the apex of the heart, and the medical staff holds the shock wave generating device and enters the heart along the pre-established pathway, and reaches the target area to be treated under the action of the contrast agent; under the action of the vascular imaging device, the balloon 1 is expanded and closely adheres to the blood vessel wall when filled with electrolyte liquid containing contrast agent; the control switch of the device is turned on, the parameters are adjusted, and the shock wave transmitter 6 starts to work and emits shock waves to treat the target area to soften the calcified part of the lesion and improve the compliance of the blood vessel; then the expansion step is performed, the pressure of the balloon 1 is continued to be increased, and the overall morphology of the plaque tissue is reconstructed through high-pressure expansion to achieve lumen modification; after the treatment is completed, the electrolyte liquid containing contrast fluid in the balloon 1 flows out of the balloon 1 to relieve the pressure of the balloon 1; finally, the catheter is withdrawn to complete the treatment process.

[0067] Through the shock wave generating device of this embodiment, only one shock wave balloon catheter is needed to complete the treatment of vascular calcification and the insufficient stent expansion or stent restenosis caused by it, and other lesions that require shock waves and high-pressure non-compliant balloon 1 to be treated at the same time, so that it can have the effect of high-pressure expansion of the lumen modification ability and shock wave emission to treat the lesions of lumen stenosis caused by vascular calcification, insufficient stent expansion caused by calcification, or stent restenosis. At the same time, the material of the balloon 1 is changed to make it more puncture-resistant, greatly reduce the rupture rate, and improve the safety of use.

[0068] The above is only a specific implementation of the utility model, but the protection scope of the utility model is not limited thereto. Any technician familiar with the technical field can easily think of various equivalent modifications or replacements within the technical scope disclosed by the utility model, and these modifications or replacements should be included in the protection scope of the utility model. Therefore, the protection scope of the utility model should be based on the protection scope of the claims.

Claims

1. A shock wave balloon catheter, comprising a balloon and a catheter body, wherein the balloon is connected to the catheter body, characterized in that: The shock wave balloon catheter further comprises: an electrode assembly for generating shock waves, wherein the electrode assembly is connected to the catheter body and is located in the balloon, and the balloon is a high-pressure non-compliant balloon.

2. The shock wave balloon catheter according to claim 1, characterized in that: The high-pressure non-compliant balloon is a single-layer balloon, and the single-layer balloon is made of one of nylon, polyethylene terephthalate and polyethylene.

3. The shock wave balloon catheter according to claim 1, characterized in that: The high-pressure non-compliant balloon is a double-layer balloon, which includes an inner layer balloon and an outer layer balloon. The inner layer balloon is made of one of nylon, polyethylene terephthalate and polyethylene, and the outer layer is made of one of thermoplastic polyurethane rubber, polyurethane resin and polyether amide block copolymer.

4. The shock wave balloon catheter according to claim 1, characterized in that: The high-pressure non-compliant balloon is a double-layer balloon, which includes an inner layer balloon and an outer layer balloon, wherein the inner layer is made of one of thermoplastic polyurethane rubber, polyurethane resin, and polyetheramide block copolymer, and the outer layer balloon is made of one of nylon, polyethylene terephthalate, and polyethylene.

5. The shock wave balloon catheter according to any one of claims 1 to 4, characterized in that: When the high-pressure non-compliant balloon is inflated to a nominal pressure value, the deformation rate of the high-pressure non-compliant balloon reaches a critical value.

6. The shock wave balloon catheter according to any one of claims 1 to 4, characterized in that: The length of the high-pressure non-compliant balloon ranges from 5 to 50 mm.

7. The shock wave balloon catheter according to any one of claims 1 to 4, characterized in that: The diameter of the high-pressure non-compliant balloon ranges from 1.5 to 10 mm.

8. The shock wave balloon catheter according to any one of claims 1 to 4, characterized in that: The deformation amount of the high-pressure non-compliant balloon is no more than 6%.

9. The shock wave balloon catheter according to any one of claims 1 to 4, characterized in that: The nominal pressure range of the high-pressure non-compliant balloon is 10-30 atm.

10. The shock wave balloon catheter according to claim 1, characterized in that: The catheter body comprises an inner tube and an outer tube, an inflation and relief cavity of the balloon is formed between the inner tube and the outer tube, the proximal end of the balloon is connected to the distal end of the outer tube, and the distal end of the balloon is connected to the distal end of the inner tube.

11. The shock wave balloon catheter according to claim 10, characterized in that: The shock wave balloon catheter further includes an operating portion connected to the proximal end of the outer tube.

12. The shock wave balloon catheter according to claim 10, characterized in that: The electrode assembly includes: an inner electrode, an outer electrode and an insulating member, the inner electrode is attached to the outer wall of the inner tube, the outer electrode is arranged on the outer periphery of the inner electrode, and the insulating member is arranged between the inner electrode and the outer electrode.

13. A shock wave generating device, characterized in that: include: A shock wave balloon catheter and a shock wave transmitter, wherein the shock wave balloon catheter is the shock wave balloon catheter according to any one of claims 1 to 12, and the shock wave transmitter is electrically connected to an electrode assembly of the shock wave balloon catheter.

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