An integrated shockwave balloon catheter and method of operating the same

Abstract

The application discloses an integrated shock wave balloon catheter and an operation method thereof. The balloon catheter comprises a balloon, an outer tube, an inner tube, a guide wire, a shock wave generating device, a control handle, a developing ring, a longitudinal shock wave electrode and a piezoelectric ceramic crystal axial shock wave electrode. The core advantage of the application is to utilize the inverse piezoelectric effect of the piezoelectric ceramic crystal to generate an axial shock wave, and to realize the focusing of the high-energy shock wave through the unique axial piezoelectric ceramic electrode structure, thereby improving the treatment efficiency on the calcified area. Moreover, the axial shock wave and the longitudinal shock wave are combined to realize the all-round calcification treatment. When the calcification is serious and the narrow channel cannot be passed, a small amount of conductive medium (a mixed solution of physiological saline and contrast agent with a volume ratio of 1:1) can be injected in the case that the balloon is not fully expanded. Firstly, the axial shock wave is generated by the piezoelectric ceramic crystal through the shock wave generating device to break a part of the calcification and open the channel for the balloon to advance. After the channel for the balloon to advance is successfully opened, the balloon is inflated, and after the balloon is attached to the surrounding calcified area, the longitudinal shock wave mode is switched to perform the calcification treatment.

Description

Technical Field

[0001] This invention belongs to the field of medical devices, and specifically relates to an integrated shockwave balloon catheter and its operation method. Background Technology

[0002] Vascular calcification is an important pathological process in cardiovascular disease, particularly common in the elderly, diabetics, and patients with chronic kidney disease, and has become a significant factor affecting cardiovascular health. The mechanisms of vascular calcification are complex, and the degree of calcification is positively correlated with the risk of cardiovascular events. Severe calcification can lead to increased vascular stiffness, affecting blood flow. Currently, the treatment of severe calcified lesions remains challenging. Traditional treatments have limited effectiveness in dealing with severe calcification, often resulting in incomplete stent expansion and poor apposition.

[0003] Intravascular lithotripsy (IVL) is a novel treatment technique for vascular calcification that has emerged in recent years. This technique borrows the principle of extracorporeal shock wave lithotripsy (ESWL) used in kidney stone treatment, breaking up calcified plaques by generating controlled shock waves within the blood vessel. IVL has shown good safety in treating coronary and peripheral vascular calcification. However, current technology still has some limitations, such as the need to improve shock wave generation efficiency and relatively limited direction and range of action. Furthermore, due to limitations in electrode structure, most current shock wave balloons are longitudinal shock wave balloons.

[0004] When treating severely calcified areas, the unidirectional longitudinal shock wave propagation pattern prevents the balloon from passing smoothly through narrow channels, thus hindering treatment. Therefore, there is a need to develop an integrated balloon capable of generating both axial and longitudinal shock waves.

[0005] Piezoelectric ceramics are functional ceramic materials exhibiting the inverse piezoelectric effect, whose core characteristic is the ability to convert mechanical energy into electrical energy. When an alternating electric field is applied along the polarization direction of a piezoelectric ceramic, the material generates periodic mechanical vibrations. Unlike traditional electrode discharge methods, piezoelectric ceramics can produce more precise and controllable mechanical vibrations, thereby generating high-quality shock waves.

[0006] Through a unique piezoelectric ceramic electrode structure design, precise focusing of shock wave energy can be achieved, and the focal point is adjustable. This concentrates the shock wave energy onto the calcified region, improving the processing efficiency of the calcified area.

[0007] Furthermore, the inverse piezoelectric effect of piezoelectric ceramics has advantages such as fast response speed, high energy conversion efficiency, and good controllability. Therefore, based on the inverse piezoelectric effect of piezoelectric ceramics, by designing a specific piezoelectric ceramic array structure, axial shock waves can be generated, providing a better solution when a balloon encounters a narrow channel and cannot pass through. Summary of the Invention

[0008] The purpose of this invention is to address the shortcomings of existing technologies by providing an integrated axial and longitudinal shock wave balloon catheter that utilizes the inverse piezoelectric effect of piezoelectric ceramic crystals to generate high-energy axial shock waves. This invention aims to solve the problem of coronary pulse shock wave balloons being unable to pass through narrow channels caused by severe calcification.

[0009] To achieve the above objectives, the present invention adopts the following technical solution: an integrated shock wave balloon catheter, comprising: a balloon, an outer tube, an inner tube, a guidewire, a shock wave generating device, a control handle, a contrast ring, a longitudinal shock wave electrode, and a piezoelectric ceramic crystal axial shock wave electrode;

[0010] The tail of the inner tube extends out of the front end of the outer tube. The balloon covers the outside of the inner tube. A guidewire is installed inside the inner tube and extends out of the tail of the outer tube. The catheter can be moved forward by the guidewire.

[0011] The imaging ring, longitudinal shock wave electrode, and piezoelectric ceramic crystal axial shock wave electrode are disposed inside the balloon and sleeved on the outside of the inner tube. The electrodes are connected to the control handle at the tail of the outer tube via wires disposed inside the inner and outer tubes. The handle is connected to the shock wave generating device to control the electrodes to generate axial and transverse shock waves. The shock waves are conducted through the fluid inside the balloon to the surface of the balloon and the tip of the catheter, softening, pyrolyzing, or breaking down the material that comes into contact with the outside of the balloon or the tip of the catheter.

[0012] Furthermore, the outer tube is provided with a tailstock at its tail end. The tailstock is multi-outlet in shape and is provided with a water injection chamber, a drain chamber, a guide wire chamber, and a wire chamber for connecting the control handle. The balloon connects the water injection chamber and the drain chamber. Liquid is injected through the water injection chamber and air is discharged from the balloon through the drain chamber. The tail ends of the water injection chamber and the drain chamber are provided with one-way straight-through valves.

[0013] Furthermore, the balloon has a cylindrical shape in the middle and cones at both ends. It can be folded before liquid is injected. The front cone is connected to the catheter tip and the inner tube, and the rear cone is connected to the outer tube.

[0014] Furthermore, the diameter of the balloon cylinder ranges from 1.25 to 4.0 mm, and the length ranges from 6 to 20 mm. The balloon is made of nylon or polyethylene terephthalate material and can be folded and wrapped around the outside of the inner tube before use.

[0015] Furthermore, the piezoelectric ceramic crystal axial shock wave electrode is located at the front of the inner tube near the tip of the conduit, and is curved into the balloon in the shape of a spherical crown or in the shape of a circular plate. From the outside to the inside, it includes a first electrode, a first piezoelectric ceramic layer, a second electrode, a second piezoelectric ceramic layer and a third electrode. The focusing center of the piezoelectric ceramic crystal axial shock wave electrode is located 5-10 mm at the front end of the balloon, and the three electrodes are controlled separately.

[0016] Furthermore, the first and third piezoelectric ceramic layers include several piezoelectric ceramic wafers, which are arranged in a circular or linear pattern.

[0017] Furthermore, the longitudinal shock wave electrode is annular and fitted in the middle of the inner tube, with one or more longitudinal shock wave electrodes evenly distributed between the two imaging rings; the longitudinal shock wave electrode includes an outer electrode, an insulating layer, and an inner electrode from the outside to the inside; the outer electrode and the inner electrode are made of platinum, platinum-iridium alloy, or stainless steel, and the insulating layer is made of polyimide.

[0018] A method for operating the aforementioned integrated shockwave balloon catheter, characterized by comprising the following steps:

[0019] (1) Insert the balloon catheter into the blood vessel;

[0020] (2) When the balloon encounters a narrow channel, inject an appropriate amount of shock wave conduction medium into the balloon to ensure that the balloon does not inflate. After completely emptying the air from the balloon, seal the balloon and push the front end of the balloon to press against the calcified area.

[0021] (3) A high-voltage pulse signal is transmitted to the axial shock wave electrode of the piezoelectric ceramic crystal through a shock wave generator to generate an axial shock wave for pretreatment of the calcified region.

[0022] (4) As the channel is opened, the balloon is delivered to the calcified location under the guidance of the guidewire. The pulse signal is turned off by the control handle to stop the generation of axial pulses.

[0023] (5) Inject shock wave transmission medium into the balloon at a pressure of about 2 to 5 atm, wait for the balloon to expand to the required extent, and seal the balloon after it is in close contact with the calcified area.

[0024] (6) A high-voltage pulse signal is sent to the longitudinal shock wave electrode through the control handle to start generating longitudinal shock waves to treat the calcified area.

[0025] Furthermore, the shock wave transmission medium is a 1:1 volume ratio mixture of physiological saline and contrast agent.

[0026] Furthermore, the voltage parameters of the piezoelectric ceramic crystal axial shock wave electrode are adjusted according to the degree of vascular stenosis:

[0027] When the degree of vascular stenosis is less than 50%, the first electrode and the second electrode are connected by a shock wave generator, and the voltage value is between 100 and 150V, and the first piezoelectric ceramic layer generates a shock wave.

[0028] When the vascular stenosis is greater than 50%, the shock wave generator connects the first electrode, the second electrode, and the third electrode, with a voltage value between 150 and 200V. Both the first piezoelectric ceramic layer and the second piezoelectric ceramic layer generate shock waves.

[0029] The core advantage of this invention lies in utilizing the inverse piezoelectric effect of piezoelectric ceramic crystals. Through a unique axial piezoelectric ceramic electrode structure, it achieves high-energy shock wave focusing, improving the processing efficiency of calcified areas. Furthermore, it combines axial and longitudinal shock waves to achieve comprehensive calcification treatment. When facing severely calcified and narrow channels that cannot be traversed, a small amount of conductive medium (a 1:1 volume ratio mixture of physiological saline and contrast agent) can be injected without fully deploying the balloon. First, the shock wave generator uses the piezoelectric ceramic crystals to generate axial shock waves, breaking up a portion of the calcification and opening a passage for the balloon to advance.

[0030] After successfully opening a passage, the balloon is inflated and then, once it adheres to the surrounding calcified area, the longitudinal shock wave mode is switched to perform calcification treatment. Attached Figure Description

[0031] Figure 1 This is a schematic diagram of the integrated axial and longitudinal shock wave balloon catheter structure in Example 1.

[0032] Figure 2 This is a schematic diagram of the front end of an integrated axial and longitudinal shockwave balloon catheter.

[0033] Figure 3 This is a schematic diagram of the structure of the piezoelectric ceramic crystal axial shock wave electrode in Example 1.

[0034] Figure 4 This is a schematic diagram of the piezoelectric ceramic wafer arrangement in Example 1.

[0035] Figure 5 This is a schematic diagram of the longitudinal shock wave electrode structure in Example 1.

[0036] Figure 6 This is a schematic diagram of balloon catheter operation when encountering a narrow channel in Example 1.

[0037] Figure 7 This is a schematic diagram of the integrated axial and longitudinal shockwave balloon catheter structure in Example 2.

[0038] Figure 8 This is a schematic diagram of the structure of the piezoelectric ceramic crystal axial shock wave electrode in Example 2. Detailed Implementation

[0039] To enable those skilled in the art to better understand the present application, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present application, and not all embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative effort should fall within the scope of protection of the present application.

[0040] It should be noted that the terms "comprising" and "having" and any variations thereof in the specification, claims and accompanying drawings of this application are intended to cover non-exclusive inclusion. For example, a process, method, system, product or device that includes a series of steps or units is not necessarily limited to those steps or units that are explicitly listed, but may include other steps or units that are not explicitly listed or that are inherent to such process, method, product or device.

[0041] An integrated axial and longitudinal shock wave balloon catheter is provided, which consists of a balloon, a shock wave generating device, a control handle, a tailstock, an outer tube, an inner tube, a radiopaque ring, a longitudinal shock wave electrode, and a piezoelectric ceramic crystal axial shock wave electrode.

[0042] This invention provides an integrated axial and longitudinal shock wave balloon catheter, which is composed of a balloon, a shock wave generating device, a control handle, a tailstock, an outer tube, an inner tube, a radiopaque ring, a longitudinal shock wave electrode, and a piezoelectric ceramic crystal axial shock wave electrode.

[0043] In this invention, the balloon serves to fill a shock wave conducting medium. The conducting medium is a 1:1 volume ratio mixture of physiological saline (0.9% concentration) and contrast agent. The contrast agent provides the physician with information on balloon expansion and positioning. The physiological saline provides good conductivity. After the balloon is injected with the conducting medium and inflated, it adheres tightly to the calcified site, allowing the shock wave to be effectively conducted to the calcified area. The shock wave is then generated by the shock wave generator to treat the calcified area.

[0044] The principle behind the generation of axial shock waves in this invention is based on the inverse piezoelectric effect of piezoelectric ceramic crystals. When a high-voltage pulse is applied to both ends of a piezoelectric ceramic, the internal domain structure of the material undergoes directional alignment, resulting in instantaneous lattice deformation. This process is called the inverse piezoelectric effect. Upon receiving a high-voltage pulse signal, the piezoelectric ceramic crystal undergoes rapid expansion and contraction within an extremely short time, generating high-frequency mechanical vibrations. The rate of deformation is proportional to the rate of change of the applied voltage, typically completed within microseconds. This rapid mechanical vibration pushes the surrounding conductive medium, generating strong compression waves within it. When the intensity of the compression wave exceeds the tolerance limit of the medium, a shock wave is formed.

[0045] This invention differs from traditional shockwave balloons in that they cannot focus shockwaves and suffer from high energy loss. To reduce energy loss and improve energy utilization efficiency, the axial shockwave electrode of the piezoelectric ceramic crystal is treated with focusing technology, and a dual-stage shockwave release is achieved through a double piezoelectric ceramic layer.

[0046] There are two focusing methods for axial shock waves in this invention. One method is to arrange a piezoelectric ceramic wafer array on an arc-shaped structure to focus the axial shock waves. The second method is to use an arc-shaped reflective ring to focus the axial shock waves.

[0047] The piezoelectric ceramic crystal axial shock wave electrode of this invention has the following advantages:

[0048] 1. It can focus the energy of shock waves, and the focusing distance can be adjusted.

[0049] 2. The energy of the shock wave can be directly controlled through the double-layer piezoelectric ceramic layer structure without the need for complex circuit design.

[0050] In this invention, the piezoelectric ceramic crystal axial shock wave electrode is placed at the front end of the balloon, and its outer circumferential dimensions are the same as those of the longitudinal shock wave electrode, so as not to affect the contraction and folding of the balloon.

[0051] In order to improve the processing efficiency of calcified areas, the front end of the balloon needs to be closely attached to the calcified blood vessel, and the front end of the balloon is protected by a soft silicone material bonded to it.

[0052] The principle of longitudinal shock wave generation in this invention is as follows: The shock wave balloon catheter is connected to an external shock wave generator. A conductive medium is injected through the water injection chamber, and the balloon is pressurized and maintained at a certain pressure. Then, the switch is turned on, and the shock wave generator sends a pulse signal. Upon receiving the pulse signal, the longitudinal shock wave discharge electrode generates a high-voltage arc. This high-voltage arc causes tiny bubbles to form in the liquid medium. These tiny bubbles then implode under high pressure for a very short time, instantly releasing enormous energy and generating a shock wave. The shock wave is conducted through the liquid medium to the balloon surface and then to the surrounding calcified area. When the shock wave reaches the hard calcified area, the ultrasonic wave front end generates compressive stress on the calcification. Because the calcified area has high compressive strength, it is not broken at this point. As the shock wave continues to propagate, when it reaches the rear interface of the calcified area, part of the shock wave is reflected, generating strong tensile stress that causes the calcification to crack. Furthermore, due to the uneven propagation of the shock wave in the calcified area, shear stress is generated, leading to the breakage of the calcified area. Therefore, under the combined action of compressive stress, tensile stress, and shear stress, the calcified area is broken up. When ultrasound waves are transmitted to the soft tissue of blood vessels, the sound waves can easily pass through because the soft tissue of blood vessels has low acoustic impedance and is elastic, without damaging the blood vessel tissue.

[0053] Example 1

[0054] like Figure 1 As shown, the integrated axial and longitudinal shock wave balloon catheter in this embodiment consists of a balloon, a shock wave generating device, a control handle, a tailstock, an outer tube, an inner tube, a radiopaque ring, a longitudinal shock wave electrode, and a piezoelectric ceramic crystal axial shock wave electrode.

[0055] The shock wave balloon catheter in this embodiment mainly consists of a balloon part, an arc-shaped piezoelectric ceramic crystal axial shock wave electrode part, and a longitudinal shock wave electrode part.

[0056] The material of the balloon body can be selected according to different usage environments. Polyamide (Nylon) can be selected when high tensile strength and high pressure resistance are required, while polyethylene terephthalate (PET) can be selected when thinner wall thickness is required. In order to improve the passage of the balloon catheter, the balloon needs to be folded. The number of folds of the balloon can be selected as 4 or 6.

[0057] The balloon body is divided into a transition section and a working section. The transition section is connected to the outer tube, and the connection method can be laser welding or thermal welding. Using thermal welding, the heating time is 20 to 45 seconds at a temperature of 175°C to 225°C. Using laser welding, the laser power can be set to 1-1.2W, and the welding time is 5-7 seconds to ensure that the total heat is not less than 6J.

[0058] The transition section has a conical overall shape. The working section has a cylindrical overall structure, and its dimensions are selected according to actual needs. The diameter range is typically 1.25 mm - 4.0 mm, increasing in increments of 0.25 mm or 0.5 mm, with 2.0 mm - 3.5 mm being the preferred size. The overall length of the balloon is available in various sizes, including 6 mm, 8 mm, 10 mm, 12 mm, 15 mm, and 20 mm, which can be selected according to actual requirements.

[0059] The balloon contains an inner tube, which primarily serves as a carrier for the electrodes and imaging ring. The outer tube can be made of materials such as polyether block amide (Pebax), polyurethane (TPU), or nylon, with polyether block amide (Pebax) being the preferred material.

[0060] The developing ring can be made of platinum-iridium alloy (90% platinum + 10% iridium or 80% + 20% iridium), pure platinum (Pt), gold (Au), tantalum (Ta), or stainless steel doped with tungsten / bismuth. Platinum-iridium alloy is preferred due to its good developing performance, strength, and biocompatibility.

[0061] The outer tube is connected to the tailstock, which has a water injection chamber, a drainage chamber, and a guide wire chamber.

[0062] like Figure 2 As shown, the front end of the balloon is protected by a protective sleeve glued to the surface. The sleeve is made of silicone and is 0.1mm thick. The length of the balloon's front end is between 10mm and 15mm.

[0063] In this embodiment, the axial shock wave is generated by a piezoelectric ceramic crystal axial shock wave electrode, as shown in the schematic diagram below. Figure 3 As shown, the overall structure consists of a first electrode, a first piezoelectric ceramic layer, a second electrode, a second piezoelectric ceramic layer, and a third electrode.

[0064] The first, second, and third electrodes are connected to the shock wave generating device via wires. The electrodes can be made of copper, and the wires are soldered to the electrodes using either tin soldering or resistance welding. The electrodes provide high-frequency pulsed electrical signals to the piezoelectric ceramic layer, causing the piezoelectric ceramic wafer to expand and compress rapidly. This high-frequency mechanical vibration propels the surrounding shock wave to the medium, generating high pressure and producing a high-energy axial shock wave.

[0065] The piezoelectric ceramic layer consists of a number of spherical piezoelectric ceramic wafers, ranging from 20 to 100. These wafers are made of high-performance materials such as lead zirconate titanate (PZT). The number of piezoelectric ceramic wafers can be selected according to actual needs.

[0066] The thickness of the piezoelectric ceramic wafer is selected between 0.1mm and 1mm, and the overall appearance is an arc-shaped disc with a curvature between 5° and 45°.

[0067] The vibration amplitude of the spherical piezoelectric ceramic wafer is directly proportional to the applied voltage; the higher the voltage, the greater the mechanical vibration amplitude. In this embodiment, the voltage supplied to the spherical piezoelectric ceramic wafer by the ultrasonic generator is between 100V and 200V, and its vibration amplitude is between 10μm and 40μm.

[0068] To ensure accurate reception of electrical pulse signals by the piezoelectric ceramic, the piezoelectric ceramic wafers should be tightly attached to the first, second, and third shock wave electrodes. To further focus the shock wave, the piezoelectric wafers are arranged in a circular pattern. Alternatively, without affecting the axial shock wave intensity, the piezoelectric wafers can be arranged in a vertical line, as shown in the schematic diagram below. Figure 4 As shown.

[0069] The advantage of circular arrangement is that it is more focused and more efficient at treating localized calcification. The advantage of linear arrangement is that it is simple to arrange and has low manufacturing cost.

[0070] Specifically, in this invention, the axial shock wave electrode of the piezoelectric ceramic crystal is composed of two piezoelectric ceramic layers. When the vascular stenosis is less than 50% and calcification is mild, and higher shock wave energy is not required, only voltage signals need to be transmitted to the first and second electrodes to generate shock waves from a single piezoelectric ceramic layer. When the vascular stenosis is greater than 50% and calcification is severe, and higher shock wave energy is required, high-frequency voltage signals are transmitted to the first, second, and third shock wave electrodes to generate shock waves from both piezoelectric ceramic layers, thereby obtaining higher energy.

[0071] To achieve better focusing and improve the energy utilization rate of the shock wave, the axial shock wave in this embodiment is formed by a piezoelectric ceramic crystal axial shock wave electrode with a certain curvature, the radius of curvature R of which is related to the focusing distance L of the shock wave. The focusing distance of the spherical piezoelectric ceramic wafer is fixed, and the focal length is usually approximately equal to the radius of curvature. The formula for calculating the radius of curvature R is:

[0072]

[0073] R: Radius of curvature (determines the focal length)

[0074] r: the aperture radius (crystal radius) of the piezoelectric wafer.

[0075] h: Sagitta (vertical height from the center of the wafer to the edge)

[0076] For short-range shock wave focusing, spherical piezoelectric ceramic wafers with smaller radii of curvature are used; for long-range shock wave focusing, spherical piezoelectric ceramic wafers with larger radii of curvature are used. Therefore, different shock wave focusing distances can be obtained based on different radii of curvature, and shock wave balloons of different specifications can be formed.

[0077] Preferably, the axial shock wave focusing center is controlled at a position 5mm-10mm away from the front end of the balloon.

[0078] In this invention, the longitudinal shock wave is generated through a longitudinal shock wave electrode, the structure of which is as follows: Figure 5 As shown. Longitudinal shock wave electrodes are evenly distributed between the imaging rings; in this embodiment, the number of electrode pairs is 4. The number of electrode pairs can be selected according to the actual length of the balloon. The longitudinal shock wave electrodes are divided into inner and outer electrodes. The electrode materials can be platinum or platinum-iridium alloys with good corrosion resistance and arc erosion resistance, or stainless steel. The inner and outer electrodes are separated by an insulating layer, preferably made of polyimide (PI) with ultra-high dielectric strength and good heat resistance. The electrodes are connected to the shock wave generating device via wires, and the electrodes are fixed to the wires with adhesive, which can be either instant adhesive or UV-cured adhesive.

[0079] This invention provides an operational procedure and parameter selection method for shock wave balloon catheters encountering narrow channels:

[0080] When the balloon encounters a narrow channel, an appropriate amount of shock wave conducting medium (a 1:1 volume ratio of physiological saline and contrast agent mixture) is first injected into the balloon to ensure that the working section of the balloon does not inflate. To avoid residual air in the balloon that could block shock wave transmission, it is necessary to wait for the conducting medium to flow out of the drainage chamber. After completely emptying the balloon of air, the drainage chamber is closed using a one-way valve. The balloon is then pushed forward until its tip is in close contact with the calcified area. Subsequently, a high-voltage pulse electrical signal is transmitted to the piezoelectric ceramic crystal axial shock wave device separately through the shock wave generator to produce an axial shock wave for pretreatment of the severely calcified area. No longitudinal shock wave is generated at this stage.

[0081] With the channel opened, the balloon, guided by the guidewire, is advanced to the calcified location. The high-voltage pulse signal is then deactivated via the control handle, stopping the axial pulse. Subsequently, a shock wave transmission medium is injected through the infusion chamber. This medium is a 1:1 volume ratio mixture of saline and contrast agent, which provides the physician with information about the balloon's expansion and position.

[0082] The balloon is then injected and pressurized to approximately 2-5 atm. After the balloon has fully inflated and is firmly against the calcified area, the one-way check valve is closed, maintaining balloon pressure. A high-voltage pulse electrical signal is then delivered to the longitudinal shock wave electrode via the control handle, initiating the generation of longitudinal shock waves to treat the calcified area around the blood vessel wall.

[0083] This shockwave balloon can be adjusted with appropriate parameters according to different degrees of vascular stenosis. When the stenosis is less than 50%, the shockwave generator connects the first and second electrodes, with a voltage range of 100-150V, and the first piezoelectric ceramic layer generates a shockwave. When the stenosis is greater than 50%, the shockwave generator connects the first, second, and third electrodes, with a voltage range of 150-200V, and both the first and second piezoelectric ceramic layers generate shockwaves, achieving a higher intensity shockwave and a more efficient vascular calcification treatment effect.

[0084] Example 2

[0085] like Figure 5 As shown, the integrated axial and longitudinal shock wave balloon catheter in this embodiment consists of a balloon, a shock wave generating device, a control handle, a tailstock, an outer tube, an inner tube, a imaging ring, a longitudinal shock wave electrode, a piezoelectric ceramic crystal axial shock wave electrode, and an arc-shaped reflective ring. The difference from Embodiment 1 lies in the structure of the piezoelectric ceramic layer in the piezoelectric ceramic crystal axial shock wave electrode.

[0086] In this embodiment, the piezoelectric ceramic is plate-shaped. The advantage of this shape is that the piezoelectric ceramic crystal does not need to be fabricated with a specific curvature, simplifying the fabrication process. The matching arc-shaped reflective ring can be made of stainless steel, and its curvature can be adjusted according to the size of the piezoelectric ceramic crystal.

[0087] The structure of this piezoelectric crystal axial shock wave device is as follows: Figure 8 As shown, the entire assembly consists of a first electrode, a second electrode, a third electrode, a first piezoelectric ceramic layer, and a second piezoelectric ceramic layer. The piezoelectric ceramic layers should be in close contact with the first, second, and third electrodes, and their ends should be fixed with adhesive.

[0088] The first, second, and third electrodes are connected to the shock wave generating device via wires. The electrodes can be made of stainless steel, and the wires are soldered to the electrodes using either soldering or resistance welding. The electrodes provide a high-voltage pulse electrical signal to the piezoelectric ceramic layer, causing the piezoelectric ceramic to generate high-frequency mechanical vibrations. The rapid expansion and compression of the piezoelectric ceramic pushes the surrounding conductive medium to generate high pressure, producing a high-energy axial shock wave.

[0089] Unlike Example 1, the piezoelectric ceramic layer in this example is a disc shape, instead of using a small piezoelectric ceramic wafer. The advantage of this electrode structure is that the piezoelectric ceramic layer does not need to be fabricated with a specific curvature, the fabrication process is simple, the overall amplitude is larger, and it can generate stronger shock wave energy.

[0090] Specifically, in this embodiment, there are two methods for adjusting the axial shock wave focusing center of the balloon:

[0091] 1. Adjustment is achieved by adjusting the distance between the arc-shaped reflective ring and the axial shock wave electrode of the piezoelectric ceramic crystal.

[0092] 2. The distance between the fixed arc-shaped reflective ring and the axial shock wave electrode of the piezoelectric ceramic crystal is adjusted by adjusting the curvature of the arc-shaped reflective ring.

[0093] Preferably, the axial shock wave focusing center is controlled at a position 5mm-10mm away from the front end of the balloon.

[0094] The matching arc-shaped reflective ring can be made of stainless steel, and its curvature can be adjusted according to the size of the piezoelectric ceramic crystal.

[0095] In this embodiment, the operation steps when the balloon catheter encounters a narrow channel are the same as those in Embodiment 1.

[0096] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. An integrated shockwave balloon catheter, characterized in that... include: Balloon, outer tube, inner tube, guidewire, shock wave generator, control handle, imaging ring, longitudinal shock wave electrode and piezoelectric ceramic crystal axial shock wave electrode; The tail of the inner tube extends out of the front end of the outer tube. The balloon covers the outside of the inner tube. A guidewire is installed inside the inner tube and extends out of the tail of the outer tube. The catheter can be moved forward by the guidewire. The imaging ring, longitudinal shock wave electrode, and piezoelectric ceramic crystal axial shock wave electrode are disposed inside the balloon and sleeved on the outside of the inner tube. The electrodes are connected to the control handle at the tail of the outer tube via wires disposed inside the inner and outer tubes. The handle is connected to the shock wave generating device to control the electrodes to generate axial and transverse shock waves. The shock waves are conducted through the fluid inside the balloon to the surface of the balloon and the tip of the catheter, softening, pyrolyzing, or breaking down the material that comes into contact with the outside of the balloon or the tip of the catheter.

2. The integrated shockwave balloon catheter according to claim 1, characterized in that: The outer tube is provided with a tailstock at its tail end. The tailstock is multi-outlet in shape and is provided with a water injection chamber, a drain chamber, a guide wire chamber, and a wire chamber for connecting the control handle. The balloon is connected to the water injection chamber and the drain chamber. Liquid is injected through the water injection chamber and air is discharged from the balloon through the drain chamber. The tail ends of the water injection chamber and the drain chamber are provided with one-way straight-through valves.

3. The integrated shockwave balloon catheter according to claim 1, characterized in that: The balloon is cylindrical in the middle and conical at both ends. It can be folded before liquid is injected. The front cone is connected to the catheter tip and the inner tube, and the rear cone is connected to the outer tube.

4. The integrated shockwave balloon catheter according to claim 3, characterized in that: The diameter of the balloon cylinder ranges from 1.25 to 4.0 mm, and the length ranges from 6 to 20 mm. The balloon is made of nylon or polyethylene terephthalate and can be folded and wrapped around the outside of the inner tube before use.

5. The integrated shockwave balloon catheter according to claim 1, characterized in that: The piezoelectric ceramic crystal axial shock wave electrode is located at the front of the inner tube near the tip of the conduit. It is shaped like a spherical crown and bends into the balloon, or it is shaped like a circular plate. From the outside to the inside, it includes a first electrode, a first piezoelectric ceramic layer, a second electrode, a second piezoelectric ceramic layer, and a third electrode. The focusing center of the piezoelectric ceramic crystal axial shock wave electrode is located 5-10 mm at the front end of the balloon. The three electrodes control the balloon separately.

6. The integrated shockwave balloon catheter according to claim 5, characterized in that: The first and third piezoelectric ceramic layers include several piezoelectric ceramic wafers, which are arranged in a circular or linear pattern.

7. The integrated shockwave balloon catheter according to claim 1, characterized in that: The longitudinal shock wave electrode is annular and fitted in the middle of the inner tube. One or more longitudinal shock wave electrodes are evenly distributed between the two developing rings. The longitudinal shock wave electrode includes an outer electrode, an insulating layer, and an inner electrode from the outside to the inside. The outer electrode and the inner electrode are made of platinum, platinum-iridium alloy, or stainless steel, and the insulating layer is made of polyimide.

8. A method of operating the integrated shockwave balloon catheter according to any one of claims 1 to 7, characterized in that... Includes the following steps: (1) Insert the balloon catheter into the blood vessel; (2) When the balloon encounters a narrow channel, inject an appropriate amount of shock wave conduction medium into the balloon to ensure that the balloon does not inflate. After completely emptying the air from the balloon, seal the balloon and push the front end of the balloon to press against the calcified area. (3) A high-voltage pulse signal is transmitted to the axial shock wave electrode of the piezoelectric ceramic crystal through a shock wave generator to generate an axial shock wave for pretreatment of the calcified region. (4) As the channel is opened, the balloon is delivered to the calcified location under the guidance of the guidewire. The pulse signal is turned off by the control handle to stop the generation of axial pulses. (5) Inject shock wave transmission medium into the balloon at a pressure of about 2 to 5 atm, wait for the balloon to expand to the required extent, and seal the balloon after it is in close contact with the calcified area. (6) A high-voltage pulse signal is sent to the longitudinal shock wave electrode through the control handle to start generating longitudinal shock waves to treat the calcified area.

9. The operating method according to claim 8, characterized in that: The shock wave transmission medium is a mixture of physiological saline and contrast agent with a volume ratio of 1:

1.

10. The operating method according to claim 9, characterized in that: The voltage parameters of the piezoelectric ceramic crystal axial shock wave electrode are adjusted according to the degree of vascular stenosis: When the degree of vascular stenosis is less than 50%, the first electrode and the second electrode are connected by a shock wave generator, and the voltage value is between 100 and 150V, and the first piezoelectric ceramic layer generates a shock wave. When the vascular stenosis is greater than 50%, the shock wave generator connects the first electrode, the second electrode, and the third electrode, with a voltage value between 150 and 200V. Both the first piezoelectric ceramic layer and the second piezoelectric ceramic layer generate shock waves.

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