A pulsatile balloon dilation catheter

Abstract

The present application relates to the technical field of medical devices, and discloses a vibrating wave balloon dilatation catheter, which comprises a catheter main body, an ultrasonic vibration device is installed on the surface of the catheter main body, balloon bodies are fixedly connected to the two sides of the surface of the catheter main body, the balloon bodies are fixed only at the two sides of the catheter main body, and the middle region is a deformable free section; pressure centering plates are arranged on the two sides of the ultrasonic vibration device and are slidingly connected to the surface of the catheter main body; the concentric constraint mechanism of the pressure centering plates and the catheter main body, the cooperative design of rigid driving plates and sealing adapter plates ensure that the pressure centering plates always coincide with the geometric axis of the catheter main body during sliding, and the two side plate bodies are synchronously and equidistantly displaced along the axial direction; the structural cooperation enables the expansion force generated after the injection of a medium to uniformly act on the balloon bodies, forcibly restricts the spatial position of the ultrasonic vibration device, and makes the ultrasonic vibration device always stably 'float' in the center of the balloon bodies, thereby significantly improving the uniformity of ultrasonic energy distribution.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a vibration wave balloon dilatation catheter. BACKGROUND

[0002] In the field of cardiovascular disease treatment, the vibration wave balloon dilatation catheter is a key medical device for dealing with vascular calcification lesions. Its core principle is to use the mechanical effect of ultrasonic waves to fragment the calcified plaque on the blood vessel wall with the help of an ultrasonic vibration device.

[0003] In clinical operation, the catheter is first accurately delivered to the lesion blood vessel segment, the balloon is expanded by injecting a medium (such as normal saline) into the balloon, the ultrasonic vibration device is attached to the calcified plaque, and then the device is started. The piezoelectric ceramic transducer produces mechanical vibration under the action of high-frequency electrical signals, outputs ultrasonic waves of a specific frequency, and transmits vibration energy to the calcified plaque through the medium such as normal saline, thereby achieving plaque fragmentation and creating conditions for blood vessel recanalization and blood supply reconstruction.

[0004] However, the existing vibration wave balloon dilatation catheter technology has significant defects. During the balloon expansion process, the injection of the medium causes the balloon to deform, and there is a lack of effective structure to ensure the spatial position of the ultrasonic vibration device. Due to the complex shape of the blood vessel (existence of bending, branching, etc.), uneven distribution of calcified plaque, and asymmetric stress after balloon expansion, the ultrasonic vibration device deviates from the center of the balloon.

[0005] Once deviated, the ultrasonic wave propagation will show obvious differences: the blood vessel wall and plaque near the device will suffer unnecessary damage, such as endothelial denudation and elastic fiber rupture, due to excessive concentration of ultrasonic energy; far from the device, the ultrasonic energy is difficult to effectively reach, the calcified plaque is not fully fragmented, affecting the treatment effect, and the blood vessel cannot be uniformly and effectively recanalized.

[0006] At the same time, due to the lack of precise positioning and centering maintenance structure, the position stability of the catheter in the blood vessel is poor, and it is easy to shift and deflect in complex blood vessel environment, which cannot ensure that the ultrasonic vibration device continuously acts on the target calcified plaque, further exacerbates the position deviation of the device in the balloon, and greatly reduces the precision and effectiveness of the treatment, thereby restricting the application effect and safety of the vibration wave balloon dilatation catheter in complex lesion treatment.

[0007] Therefore, the present application provides a vibration wave balloon dilatation catheter. SUMMARY

[0008] The present application aims to provide a vibration wave balloon dilatation catheter to solve the problems raised in the background.

[0009] In order to achieve the above object, the present application provides the following technical scheme: a vibrating wave balloon dilatation catheter, comprising a catheter main body, an ultrasonic vibration device is mounted on the surface of the catheter main body, two sides of the surface of the catheter main body are fixedly connected with a balloon body, only two sides of the balloon body are fixed with the catheter main body, and the middle region is a deformable free section, two sides of the ultrasonic vibration device are provided with a pressure centering plate, the pressure centering plate is slidably connected to the surface of the catheter main body, and the pressure centering plate is located in the deformable free section inside the balloon body, a plurality of centering expansion pieces are linearly and equidistantly arranged and mounted between one side of the surface of the pressure centering plate facing the inner wall of the balloon body and the inner wall of the balloon body, a medium channel is arranged in the catheter main body, and the medium channel is in communication with the space surrounded by the balloon body and the pressure centering plate.

[0010] Preferably, the pressure centering plate is composed of a rigid driving plate and a sealing adapter plate, the rigid driving plate is sealingly and slidably connected to the surface of the catheter main body, the edge of the sealing adapter plate is attached to the inner wall of the balloon body, and the sealing adapter plate is in sliding sealing cooperation with the balloon body, when the pressure centering plate slides along the catheter main body, the sealing adapter plate moves synchronously with the rigid driving plate, and the edge thereof keeps sealing contact with the inner wall of the balloon body.

[0011] Preferably, the inner wall of the balloon body is circumferentially provided with an external sealing groove corresponding to the sliding path of the sealing adapter plate, the edge of the sealing adapter plate is provided with an external sealing protrusion matched with the external sealing groove, and the outer side of the external sealing protrusion is embedded with a medical silica gel sealing strip, so as to ensure that the edge of the sealing adapter plate keeps sealing contact with the inner wall of the balloon body and prevents medium leakage.

[0012] Preferably, the pressure centering plate is concentrically arranged with the catheter main body, the geometric center axis of the pressure centering plate coincides with the center axis of the catheter main body, and the concentric state of the pressure centering plate keeps unchanged when the pressure centering plate slides along the catheter main body.

[0013] Preferably, the centering expansion piece is fixedly connected to the surface of the sealing adapter plate, the centering expansion piece is in a bent shape, the bending direction of the centering expansion piece is towards the inner wall of the balloon body, the centering expansion piece is an elastic wire, the inner wall of the balloon body is symmetrically mounted with a limiting shell in a ring-shaped and equidistant arrangement, and one side of the centering expansion piece away from the pressure centering plate is mounted in the interior of the limiting shell.

[0014] Preferably, a telescopic bellows is mounted between the surface of the rigid driving plate and the surface of the catheter main body, and the bellows is located at two sides of the ultrasonic vibration device.

[0015] Preferably, one end of the bellows is sealingly and fixedly connected with the surface of the rigid driving plate, the other end is fixedly connected with the surface of the catheter main body, and the middle part of the bellows is a free telescopic section.

[0016] Preferably, the central expansion piece is an expansion plate, the surface of the rigid driving plate extends towards the side away from the ultrasonic vibration device, the extended surface of the rigid driving plate is rotationally connected with a number of driving shafts corresponding to the number of central expansion pieces, and the inner surface of each central expansion piece is rotationally connected with two driven shafts.

[0017] Preferably, the rotation directions of the driving shafts and the driven shafts are opposite.

[0018] Preferably, a plurality of elastic connecting pieces are arranged between the opposite surfaces of the two rigid driving plates, and the elastic connecting pieces are telescopic elastic structures.

[0019] Preferably, the elastic connecting pieces are medical nickel-titanium memory alloy springs.

[0020] Preferably, the ultrasonic vibration device is provided with a piezoelectric ceramic transducer, when an external ultrasonic generator applies a high-frequency electric signal to the transducer along a preset line inside the catheter body through a wire, the piezoelectric ceramic generates mechanical vibration based on the inverse piezoelectric effect, and outputs ultrasonic waves with a frequency of 20 kHz-100 kHz, and the shell of the ultrasonic vibration device is packaged with medical polysulfone material, which not only guarantees the vibration conduction efficiency of the piezoelectric ceramic, but also has good biocompatibility and pressure resistance.

[0021] Preferably, the medium channel is connected with a micro-liquid injection pump, the injected medium is physiological saline, and when in use, the injection rate and total amount of the physiological saline are accurately controlled by the micro-liquid injection pump, so that the pressure in the capsule body stably rises and drives the central pressure plate to slide.

[0022] Preferably, the injected physiological saline is medical isotonic saline, which matches the osmotic pressure of human blood, can reduce the damage caused by the osmotic pressure difference of vascular endothelial cells, and the physiological saline as an ultrasonic wave conduction medium has a sound impedance close to human tissues, which can effectively reduce the energy attenuation of ultrasonic waves in the conduction process and guarantee the ultrasonic fragmentation effect.

[0023] Compared with the prior art, the present application has the following advantages:

[0024] 1. Based on the concentric constraint mechanism between the pressure centering plate and the catheter body, the coordinated design of the rigid drive plate and the sealing adapter plate ensures that the pressure centering plate always maintains geometric axis coincidence with the catheter body during sliding. The two side plates move synchronously and equidistantly along the axial direction. This structural combination allows the expansion force generated after the injection of the medium to act evenly on the capsule, forcibly constraining the spatial position of the ultrasonic vibration device, making it always stably "suspended" in the center of the capsule. This significantly improves the uniformity of ultrasonic energy distribution and effectively improves the problem of excessive or insufficient local energy concentration caused by the displacement of the vibration device in the existing technology. It ensures that calcified plaques in all areas of the blood vessel wall can be fully fragmented, while avoiding damage to the vascular endothelium. Compared with the problem of unilateral displacement of the vibration device caused by the lack of concentric constraint in traditional catheters, this mechanism fundamentally guarantees the safety and effectiveness of treatment.

[0025] 2. The linkage mechanism between the elastic wire central expansion component and the limiting shell is another important advantage. The high deformation characteristics of the elastic wire allow it to adaptively adjust the bending angle and support force according to the vascular morphology. When encountering plaque protrusions in curved blood vessels, it can locally contract to avoid them, and moderately extend to provide stable support on the concave side of the blood vessel. The constraint of the limiting shell on the end of the elastic wire ensures the controllability of the expansion trajectory. This design greatly improves the adaptability of the catheter to complex vascular scenarios and effectively improves the problem that traditional rigid expansion structures are prone to causing the vibration device to deviate or even damage the blood vessel wall in curved blood vessels or complex plaque environments. It allows the catheter to maintain the symmetrical distribution of the pressure central plate in complex lesions with many calcium deposits and curved blood vessels, ensuring the neutral and stable position of the ultrasonic vibration device.

[0026] 3. For mild calcification of straight vessels, the linkage mechanism between the rigid expansion plate and the reverse axis exhibits unique advantages. The reverse rotation of the active and driven axes creates a "constraint-deflection-expansion" effect, allowing the expansion plate to move slightly with the pressure centering plate while being controllably deflected around the axis. This concentrates and stabilizes the opening force on the cyst. This structural combination significantly improves the positioning accuracy of the vibration device within the straight vessel, enabling the rapid establishment of stable radial support. It effectively improves the problem of neutral instability caused by the dispersed support force of traditional elastic expansion structures, while reducing secondary damage to mild calcified plaques. Compared to the shortcomings of existing technologies in treating mild calcification of straight vessels, which struggle to balance stability and safety, this mechanism achieves an organic combination of precise positioning and gentle treatment.

[0027] 4、The corrugated tube elastic reset mechanism stores elastic restoring force through the tensile deformation of the telescopic corrugated tube. After the treatment is completed, it can drive the pressure centering plate to reset quickly, make the centering expansion piece fold, and the capsule collapse to recover low profile, which is convenient for safe withdrawal from the blood vessel. At the same time, the elastic properties of the corrugated tube can buffer the pressure fluctuation in real time, avoid the vibration device offset caused by instantaneous pressure change, and improve the stability of the circulation of the catheter. This mechanism improves the stability and safety of the treatment process compared with the prior art, which improves the risk of pressure drop and blood vessel injury caused by the dependence of traditional catheters on medium suction reset. BRIEF DESCRIPTION OF DRAWINGS

[0028] Figure 1 is a partial cross-sectional perspective view of the main structure in embodiment one of the present application;

[0029] Figure 2 is a partial exploded perspective view of the main structure in embodiment one of the present application;

[0030] Figure 3 is a partial cross-sectional perspective view of the main structure in embodiment two of the present application; Figure 1 is an enlarged structure perspective view of position A in the present application;

[0031] Figure 4 is a partial perspective view of the main structure in embodiment one of the present application;

[0032] Figure 5 is a cross-sectional perspective view of the centering expansion piece in embodiment one of the present application;

[0033] Figure 6 is a partial cross-sectional perspective view of the main structure in embodiment two of the present application;

[0034] Figure 7 is a partial exploded perspective view of the main structure in embodiment two of the present application;

[0035] Figure 8 is a planar view of the movement state of the centering expansion piece, driving shaft and driven shaft in embodiment two of the present application.

[0036] In the figure:

[0037] 1, catheter main body; 11, medium channel; 2, ultrasonic vibration device; 3, capsule; 4, pressure centering plate; 401, rigid driving plate; 402, sealing adapter plate; 41, centering expansion piece; 42, limiting shell; 43, corrugated tube; 44, driving shaft; 45, driven shaft; 46, elastic connecting piece. DETAILED DESCRIPTION

[0038] With reference to the drawings of the embodiments of the present application, the technical solutions in the embodiments of the present application will be described clearly and completely. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments of the present application. Based on the embodiments of the present application, all the other embodiments obtained by those of ordinary skill in the art without creative work fall within the protection scope of the present application.

[0039] It should be noted that the ultrasonic vibration device 2 only provides the function of generating ultrasonic vibration, the medium channel 11 and the external micro-injection pump only provide the function of injecting physiological saline, and the external sealing protrusion, the external sealing groove and the medical silica gel sealing strip only provide the function of sliding sealing. The working principles and specific structures of the above structures are prior art, and therefore, in view of the universality of the above structures, the specific principles will not be described in detail.

[0040] Embodiment one, please refer to as Figures 1 to 5 A wave balloon dilatation catheter, comprising a catheter body 1, the surface of the catheter body 1 is provided with an ultrasonic vibration device 2, both sides of the surface of the catheter body 1 are fixedly connected with a balloon body 3, the balloon body 3 is fixed only at both sides of the catheter body 1, and the middle region is a deformable free section, both sides of the ultrasonic vibration device 2 are provided with a pressure centering plate 4, the pressure centering plate 4 is slidingly connected to the surface of the catheter body 1, and the pressure centering plate 4 is located in the deformable free section inside the balloon body 3, a plurality of centering expansion pieces 41 are arranged in linear equidistance between the side of the surface of the pressure centering plate 4 facing the inner wall of the balloon body 3 and the inner wall of the balloon body 3, a medium channel 11 is arranged inside the catheter body 1, and the medium channel 11 is in communication with the space surrounded by the balloon body 3 and the pressure centering plate 4.

[0041] It should be noted that the pressure centering plate 4 is composed of a rigid drive plate 401 and a sealing adapter plate 402. The rigid drive plate 401 is slidably connected to the surface of the catheter body 1. The edge of the sealing adapter plate 402 is in contact with the inner wall of the capsule 3, and the sealing adapter plate 402 and the capsule 3 are in a sliding sealing fit. When the pressure centering plate 4 slides along the catheter body 1, the sealing adapter plate 402 moves synchronously with the rigid drive plate 401, and its edge always maintains a sealing contact with the inner wall of the capsule 3. The inner wall of the capsule 3 corresponds to the sliding path of the sealing adapter plate 402 and is provided with an external sealing groove in the circumference. The edge of the sealing adapter plate 402 is provided with an external sealing protrusion that matches the external sealing groove. A medical silicone sealing strip is embedded on the outer side of the sealing protrusion to ensure that the edge of the sealing adapter plate 402 always maintains a sealed contact with the inner wall of the capsule 3, preventing media leakage. The pressure centering plate 4 is concentrically set with the catheter body 1, and the geometric center axis of the pressure centering plate 4 coincides with the center axis of the catheter body 1. When the pressure centering plate 4 slides along the catheter body 1, its concentric state remains unchanged. The centering expansion member 41 is fixedly connected to the surface of the sealing adapter plate 402. The centering expansion member 41 is bent, and its bending direction is towards the inner wall of the capsule 3. The centering expansion member 41 is an elastic wire. The inner wall of the capsule 3 is symmetrically installed with equidistant ring-shaped limit shells 42. The centering expansion member 41 is away from the pressure centering plate 402. One side of the middle plate 4 is installed inside the limiting housing 42. A retractable bellows 43 is installed between the rigid drive plate 401 and the surface of the conduit body 1. The bellows 43 is located on both sides of the ultrasonic vibration device 2. One end of the bellows 43 is sealed and fixedly connected to the surface of the rigid drive plate 401, and the other end is fixedly connected to the surface of the conduit body 1. The middle part of the bellows 43 is a free-expanding section. The ultrasonic vibration device 2 has a built-in piezoelectric ceramic transducer. When an external ultrasonic generator applies a high-frequency electrical signal to the transducer through a wire along a preset circuit inside the conduit body 1, the piezoelectric ceramic generates mechanical vibration based on the inverse piezoelectric effect, outputting ultrasonic waves with a frequency of 20kHz-100kHz. The outer shell of the device 2 is encapsulated with medical-grade polysulfone material, which ensures the vibration transmission efficiency of the piezoelectric ceramic and has good biocompatibility and pressure resistance. The medium channel 11 is connected to a micro-infusion pump, and the injected medium is physiological saline. During use, the injection rate and total amount of physiological saline are precisely controlled by the micro-infusion pump, so that the pressure inside the capsule 3 rises steadily, driving the pressure center plate 4 to slide. The injected physiological saline is medical isotonic physiological saline, which matches the osmotic pressure of human blood, and can reduce the damage to vascular endothelial cells caused by osmotic pressure differences. In addition, as an ultrasonic transmission medium, the acoustic impedance of physiological saline is close to that of human tissue, which can effectively reduce the energy attenuation of ultrasonic waves during transmission and ensure the ultrasonic fragmentation effect.

[0042] Specifically, in clinical practice, after the catheter body 1 is delivered to the lesion site via the vascular interventional route, the position is first confirmed under imaging equipment by the imaging mark (usually an embedded medical imaging ring) at the front end of the catheter body 1 to ensure that the ultrasonic vibration device 2 is aligned with the calcified plaque area. At this time, the capsule 3 is in an undilated state, the pressure centering plate 4 maintains its initial position under the natural elastic force of the corrugated tube 43, and the elastic wire of the centering expansion member 41 is in a naturally bent state. The overall structure fits the surface of the catheter body 1, which facilitates flexible delivery in the blood vessel.

[0043] When treatment begins, an external micro-infusion pump injects medical isotonic saline into the closed space surrounding the capsule 3 and the pressure center plate 4 through the medium channel 11. As the saline is continuously injected, the pressure in the closed space gradually increases, pushing the pressure center plates 4 on both sides to slide synchronously away from the ultrasonic vibration device 2 along the axial direction of the catheter body 1.

[0044] Since the pressure centering plate 4 is concentrically set with the conduit body 1, and its geometric center axis always coincides with the center axis of the conduit body 1, the sliding distance of the pressure centering plates 4 on both sides is completely symmetrical, avoiding the risk of displacement caused by unilateral force, and laying the foundation for maintaining the neutral position of the ultrasonic vibration device 2.

[0045] During the sliding of the pressure centering plate 4, the sealing adapter plate 402 moves synchronously with the rigid drive plate 401. The external sealing protrusions on its edge precisely match the external sealing grooves on the inner wall of the capsule 3. The embedded medical silicone sealing strip always fits tightly against the inner wall of the groove due to its elastic deformation, forming a dynamic sealing barrier to ensure that all physiological saline is used to drive the dilation action without leakage. At the same time, the sealed sliding connection between the rigid drive plate 401 and the catheter body 1 further enhances the sealing performance of the system, maximizing the pressure transmission efficiency.

[0046] As the pressure centering plate 4 slides, the elastic wire of the centering expansion member 41, which is fixed between the surface of the sealing adapter plate 402 and the limiting housing 42, is squeezed. Under the action of the squeezing force, the elastic wire pushes the deformable free section of the bladder 3 outward in a synchronous manner, so that the bladder 3 expands evenly from the middle area.

[0047] During this process, the expansion force of the elastic wires on both sides is transmitted to the catheter body 1 through the pressure centering plate 4, forming a symmetrical radial support force, which stably "suspends" the catheter body 1 and the ultrasonic vibration device 2 on its surface in the center of the blood vessel, thus maintaining a neutral position.

[0048] When the capsule 3 expands to lightly touch the blood vessel wall, physiological saline fills the space between the capsule 3 and the ultrasonic vibration device 2 to form a liquid cushion, at which point the ultrasonic vibration device 2 starts working.

[0049] An external ultrasound generator inputs a high-frequency electrical signal to the built-in piezoelectric ceramic transducer via a wire. The piezoelectric ceramic generates mechanical vibration based on the inverse piezoelectric effect, and the output ultrasound waves are evenly transmitted to the calcified plaques on the blood vessel wall through the saline pad. Since the ultrasound vibration device 2 is in a neutral position, the ultrasound waves it emits propagate evenly in all directions, and the energy distribution is uniform, which can effectively avoid blood vessel damage caused by excessive local energy or incomplete plaque fragmentation caused by insufficient energy.

[0050] During treatment, if there is slight curvature of the blood vessel or uneven distribution of plaque, the elastic deformation characteristics of the central dilator 41 (elastic wire) will play an adaptive adjustment role. When the pressure on one side of the blood vessel wall increases, the elastic wire on the corresponding side will absorb the pressure by slight contraction, while the elastic wire on the opposite side maintains the support force. This dynamic balance ensures that the pressure central plate 4 is always symmetrically distributed around the central axis of the catheter body 1, thereby maintaining the neutral position of the ultrasonic vibration device 2. At the same time, the bellows 43 slides with the pressure central plate 4 and generates tensile deformation. The stored elastic recovery force can buffer pressure fluctuations in real time and avoid device displacement caused by instantaneous changes in injection pressure.

[0051] After treatment, the micro-infusion pump stops infusing and slowly aspirates saline. The pressure in the enclosed space decreases, and the elastic restoring force of the bellows 43 causes the pressure centering plate 4 to reset. The centering expansion member 41 (elastic wire) contracts back to its initial bent state under its own elastic force, and the cyst 3 collapses. The entire device returns to a low profile state, which facilitates safe removal from the blood vessel.

[0052] It should be noted that, since the central expansion member 41 adopts an elastic wire structure, it has excellent deformability and elastic recovery ability. It is more advantageous when facing complex lesion scenarios with a large distribution of calcium plaques and tortuous blood vessels. The elastic wire can adaptively adjust the bending angle and support force according to the shape of the tortuous blood vessel. It can avoid the protrusion of calcified plaques by local contraction and provide stable support by moderate extension on the concave side of the tortuous blood vessel. This avoids excessive pressure on the blood vessel wall by the rigid structure and can always maintain the symmetrical distribution of pressure on the central plate 4 under complex morphology. This ensures that the neutral position of the ultrasonic vibration device 2 is not affected by the tortuous blood vessel or uneven plaque distribution, so that safe and effective ultrasonic plaque fragmentation treatment can still be achieved in complex vascular environments.

[0053] Example 2, please refer to the following: Figures 6 to 8 As shown, the central expansion member 41 is an expansion plate, and the surface of the rigid drive plate 401 extends toward the side away from the ultrasonic vibration device 2. The extended section of the rigid drive plate 401 is rotatably connected to an active shaft 44 that matches the number of central expansion members 41. The inner surface of each central expansion member 41 is rotatably connected to two driven shafts 45 between it and the surface of the conduit body 1.

[0054] It should be noted that the rotation directions of the drive shaft 44 and the driven shaft 45 are opposite. Several elastic connectors 46 are installed between the opposing surfaces of the two rigid drive plates 401. The elastic connectors 46 are stretchable elastic structures and are made of medical nickel-titanium memory alloy springs.

[0055] Specifically, based on Example 1, as the saline solution is filled, the pressure inside the capsule 3 gradually increases, pushing the rigid drive plates 401 on both sides to move away from the ultrasonic vibration device 2 synchronously along the axial direction of the catheter body 1.

[0056] During the pressure transmission process, when the rigid drive plate 401 slides, the active shaft 44 on the surface of its extension section begins to rotate under the action of thrust. Since the active shaft 44 and the driven shaft 45 rotate in opposite directions, they form a "reverse linkage constraint": the active shaft 44 attempts to push the central expansion member 41 (expansion plate) to expand outward significantly, but the driven shaft 45 on the inner side of the expansion plate is constrained by the surface of the conduit body 1, limiting its excessive displacement.

[0057] Under this constraint, the expansion plate can only move slightly following the pressure center plate 4. At the same time, due to the opposite rotation of the drive shaft 44 and the driven shaft 45, the expansion plate undergoes a controllable deflection around the axis—when the drive shaft 44 rotates clockwise, the driven shaft 45 rotates counterclockwise, forcing the expansion plate to push against the inner wall of the bladder 3.

[0058] This "restricted-deflected-expanded" linkage mechanism causes the circumferentially distributed expansion plates to expand synchronously toward the inner wall of the capsule 3, promoting the uniform expansion of the deformable free segment of the capsule 3.

[0059] Because the expansion plate is a rigid structure, the force exerted on the cyst 3 during its expansion process is more concentrated and controllable. The resulting radial support force is transmitted to the catheter body 1 through the pressure centering plate 4, which stably "suspends" the ultrasonic vibration device 2 in the center of the blood vessel, thus maintaining a neutral position.

[0060] When the capsule 3 expands to contact the blood vessel wall, the saline solution forms a uniform medium layer between the capsule 3 and the ultrasonic vibration device 2. The ultrasonic vibration device 2 starts working, and the external ultrasonic generator drives the piezoelectric ceramic transducer through the wire. The output ultrasonic waves act uniformly on the calcified plaque through the saline layer. Since the ultrasonic vibration device 2 is in a neutral position, the ultrasonic waves propagate a consistent distance in all directions, and the energy distribution is uniform, avoiding vascular damage or plaque fragmentation failure caused by excessive / insufficient local energy.

[0061] It should be noted that, compared with Embodiment 1, the rigid expansion plate + reverse axis linkage structure of this embodiment is more suitable for scenarios with small calcified plaques and relatively straight blood vessel morphology. The reason is that: the rigid expansion plate has concentrated support force, which can quickly establish a stable neutral position, suitable for precise positioning in straight blood vessels. Secondly, the "small-amplitude deflection + expansion" of the reverse axis linkage provides more uniform compression of the blood vessel wall, which can reduce secondary damage to mild calcified plaques caused by elastic deformation. Finally, if the blood vessel is curved or the calcified plaque is complex, the deflection of the rigid expansion plate is restricted, which can easily lead to support imbalance. However, in scenarios with straight blood vessels and mild calcification, its stability and accuracy are significantly better than the elastic wire structure.

[0062] After treatment, the micro-infusion pump draws back saline, the elastic connector 46 releases elastic potential energy, pulls the rigid drive plate 401 to reset, the active shaft 44 and the driven shaft 45 rotate in opposite directions, causing the expansion plate to close and fit the catheter body 1, the capsule 3 collapses and restores its low profile, making it easy to safely withdraw from the blood vessel.

[0063] It should be noted that, in this document, relational terms such as "first" and "second" are used merely to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0064] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A shockwave balloon dilation catheter, comprising a catheter body (1), wherein an ultrasonic vibration device (2) is mounted on the surface of the catheter body (1), and a balloon (3) is fixedly connected to both sides of the surface of the catheter body (1), wherein the balloon (3) is fixed to the catheter body (1) only on both sides, and the middle region is a deformable free segment, characterized in that: The ultrasonic vibration device (2) is provided with pressure centering plates (4) on both sides. The pressure centering plates (4) are slidably connected to the surface of the catheter body (1). The pressure centering plates (4) are located in the deformable free section inside the capsule (3). Several centering expansion members (41) are installed linearly and equidistantly between the side of the pressure centering plate (4) facing the inner wall of the capsule (3) and the inner wall of the capsule (3). The catheter body (1) is provided with a medium channel (11). The medium channel (11) is connected to the space surrounded by the capsule (3) and the pressure centering plates (4). The pressure centering plate (4) is composed of a rigid drive plate (401) and a sealing adapter plate (402). The rigid drive plate (401) is slidably connected to the surface of the catheter body (1). The edge of the sealing adapter plate (402) is in contact with the inner wall of the capsule (3), and the sealing adapter plate (402) and the capsule (3) are in sliding sealing contact. When the pressure centering plate (4) slides along the catheter body (1), the sealing adapter plate (402) moves synchronously with the rigid drive plate (401), and its edge always maintains a sealing contact with the inner wall of the capsule (3). The pressure center plate (4) is set concentrically with the catheter body (1). The geometric center axis of the pressure center plate (4) coincides with the center axis of the catheter body (1). When the pressure center plate (4) slides along the catheter body (1), its concentric state remains unchanged.

2. The waveguide balloon dilation catheter according to claim 1, characterized in that: The centering expansion member (41) is fixedly connected to the surface of the sealing adapter plate (402). The centering expansion member (41) is bent, and its bending direction is towards the inner wall of the bladder (3). The centering expansion member (41) is an elastic wire. The inner wall of the bladder (3) is symmetrically installed with a ring-shaped equidistant arrangement of the limiting housing (42). The side of the centering expansion member (41) away from the pressure centering plate (4) is installed inside the limiting housing (42).

3. The waveguide balloon dilation catheter according to claim 2, characterized in that: A retractable corrugated tube (43) is installed between the rigid drive plate (401) and the surface of the conduit body (1), and the corrugated tube (43) is located on both sides of the ultrasonic vibration device (2).

4. The waveguide balloon dilation catheter according to claim 3, characterized in that: One end of the corrugated pipe (43) is sealed and fixedly connected to the surface of the rigid drive plate (401), and the other end is fixedly connected to the surface of the conduit body (1). The middle part of the corrugated pipe (43) is a free expansion and contraction section.

5. The waveguide balloon dilation catheter according to claim 1, characterized in that: The central expansion member (41) is an expansion plate. The surface of the rigid drive plate (401) extends toward the side away from the ultrasonic vibration device (2). The extended section of the rigid drive plate (401) is rotatably connected to an active shaft (44) that matches the number of central expansion members (41). The inner surface of each central expansion member (41) is rotatably connected to two driven shafts (45) between it and the surface of the conduit body (1).

6. The waveguide balloon dilation catheter according to claim 5, characterized in that: The driving shaft (44) rotates in the opposite direction to the driven shaft (45).

7. The waveguide balloon dilation catheter according to claim 5, characterized in that: A plurality of elastic connectors (46) are installed between the opposing surfaces of the two rigid drive plates (401), and the elastic connectors (46) are stretchable elastic structures.

8. The waveguide balloon dilation catheter according to claim 7, characterized in that: The elastic connector (46) is made of medical nickel-titanium memory alloy spring.

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