CN120788677B - A shockwave balloon dilation catheter - Google Patents
A shockwave balloon dilation catheterInfo
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- CN120788677B CN120788677B CN202511258691.XA CN202511258691A CN120788677B CN 120788677 B CN120788677 B CN 120788677B CN 202511258691 A CN202511258691 A CN 202511258691A CN 120788677 B CN120788677 B CN 120788677B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B17/22004—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
- A61B17/22012—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
- A61B17/2202—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement the ultrasound transducer being inside patient's body at the distal end of the catheter
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M29/00—Dilators with or without means for introducing media, e.g. remedies
- A61M29/02—Dilators made of swellable material
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B17/22004—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
- A61B2017/22027—Features of transducers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22051—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
- A61B2017/22065—Functions of balloons
- A61B2017/22069—Immobilising; Stabilising
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22051—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
- A61B2017/22065—Functions of balloons
- A61B2017/22071—Steering
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22081—Treatment of vulnerable plaque
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Heart & Thoracic Surgery (AREA)
- Surgery (AREA)
- Biomedical Technology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Vascular Medicine (AREA)
- Mechanical Engineering (AREA)
- Anesthesiology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Hematology (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Ultra Sonic Daignosis Equipment (AREA)
Abstract
本发明涉及医疗器械技术领域，且公开了一种振波球囊扩张导管，包括导管主体，导管主体表面安装有超声波振动装置，导管主体表面两侧固定连接有囊体，囊体仅两侧与导管主体固定，中间区域为可形变自由段，超声波振动装置的两侧设置有压力居中板，压力居中板滑动连接于导管主体表面，源于压力居中板与导管主体的同心约束机制，通过刚性驱动板与密封适配板的协同设计，确保压力居中板在滑动过程中始终与导管主体保持几何轴线重合，两侧板体沿轴向同步等距位移，这种结构配合使注入介质后产生的扩张力能均匀作用于囊体，强制约束超声波振动装置的空间位置，使其始终稳定“悬浮”于囊体中心，显著提高了超声波能量分布的均匀性。
This invention relates to the field of medical device technology and discloses a shockwave balloon dilation catheter, comprising a catheter body, an ultrasonic vibration device mounted on the surface of the catheter body, and a balloon fixedly connected to both sides of the surface of the catheter body. The balloon is fixed to the catheter body only on both sides, with the middle region being a deformable free section. Pressure centering plates are provided on both sides of the ultrasonic vibration device and are slidably connected to the surface of the catheter body. Due to the concentric constraint mechanism between the pressure centering plate and the catheter body, and through the collaborative design of the rigid drive plate and the sealing adapter plate, it is ensured that the pressure centering plate always maintains geometric axis coincidence with the catheter body during sliding. The two side plates are synchronously and equidistantly displaced along the axial direction. This structural combination allows the expansion force generated after the injection of the medium to act evenly on the balloon, forcibly constraining the spatial position of the ultrasonic vibration device, so that it is always stably "suspended" in the center of the balloon, significantly improving the uniformity of ultrasonic energy distribution.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a vibration wave balloon dilation catheter.
Background
In the field of cardiovascular disease treatment, a vibration wave balloon dilation catheter is a key medical instrument for treating vascular calcification lesions, and the core principle is that an ultrasonic vibration device is used for carrying out fragmentation treatment on calcified plaques on the vascular wall by utilizing the mechanical effect of ultrasonic waves.
In clinical operation, firstly, the catheter is accurately conveyed to a lesion vessel segment, the balloon is expanded by injecting a medium (such as physiological saline) into the balloon, the ultrasonic vibration device is close to calcified plaque, then the device is started, the piezoelectric ceramic transducer generates mechanical vibration under the action of high-frequency electric signals, ultrasonic waves with specific frequency are output, vibration energy is transmitted to the calcified plaque by means of conduction of the physiological saline and other mediums, plaque fragmentation is realized, and conditions are created for vascular recanalization and blood circulation reconstruction.
However, the existing vibrating wave balloon dilation catheter technology has obvious defects, and in the balloon dilation link, when the medium is injected to deform the balloon, an effective structure is lacking to ensure the spatial position of the ultrasonic vibration device, and the ultrasonic vibration device deviates from the center of the balloon due to the fact that the blood vessel is complex in morphology (bending, bifurcation and the like) and calcified plaque is unevenly distributed, and stress asymmetry easily occurs after the balloon is dilated.
Once deviated, the ultrasonic wave propagation shows obvious differences that the vascular wall and plaque close to one side of the device can suffer unnecessary damage such as vascular endothelial peeling and elastic fiber fracture due to excessive concentration of ultrasonic energy, and the calcified plaque is insufficient due to insufficient fragmentation of the ultrasonic energy which is difficult to reach far from one side of the device, so that the treatment effect is affected, and the uniform and effective recanalization of the blood vessel can not be realized.
Meanwhile, due to the lack of a precise positioning and centering maintaining structure, the position stability of the catheter in the blood vessel is poor, the catheter is easy to shift and deflect in a complex blood vessel environment, the ultrasonic vibration device cannot be ensured to continuously act on the target calcified plaque, the position deviation of the ultrasonic vibration device in the balloon is further aggravated, the treatment accuracy and effectiveness are greatly reduced, and the application effect and safety of the vibration wave balloon dilating catheter in complex lesion treatment are restricted.
Therefore, the invention provides a vibrating wave balloon dilation catheter.
Disclosure of Invention
The invention aims to provide a vibrating wave balloon dilation catheter for solving the problems in the background art.
In order to achieve the above purpose, the invention provides the technical scheme that the vibration wave balloon dilation catheter comprises a catheter main body, wherein an ultrasonic vibration device is arranged on the surface of the catheter main body, two sides of the surface of the catheter main body are fixedly connected with balloon bodies, the balloon bodies are only fixed with the catheter main body, the middle area is a deformable free section, pressure centering plates are arranged on the two sides of the ultrasonic vibration device and are slidably connected to the surface of the catheter main body, the pressure centering plates are positioned in deformable free sections in the balloon bodies, a plurality of centering dilation pieces are linearly distributed between one side of the surface of the pressure centering plates facing the inner wall of the balloon body and the inner wall of the balloon body at equal intervals, and medium channels are arranged in the catheter main body and are communicated with the space surrounded by the balloon bodies and the pressure centering plates.
Preferably, the pressure centering plate is composed of a rigid driving plate and a sealing adapting plate, the rigid driving plate is connected to the surface of the catheter main body in a sealing sliding manner, the edge of the sealing adapting plate is attached to the inner wall of the capsule body, the sealing adapting plate is in sliding sealing fit with the capsule body, and when the pressure centering plate slides along the catheter main body, the sealing adapting plate moves synchronously with the rigid driving plate, and the edge of the sealing adapting plate always keeps sealing contact with the inner wall of the capsule body.
Preferably, the inner wall of the bag body corresponds to the sliding path of the sealing adapting plate, an external sealing groove is circumferentially arranged, an external sealing bulge matched with the external sealing groove is arranged at the edge of the sealing adapting plate, and meanwhile, a medical silica gel sealing strip is embedded at the outer side of the external sealing bulge, so that the edge of the sealing adapting plate is always kept in sealing contact with the inner wall of the bag body, and medium leakage is prevented.
Preferably, the whole pressure centering plate is arranged concentrically with the catheter body, the geometric central axis of the pressure centering plate coincides with the central axis of the catheter body, and the concentric state of the pressure centering plate is kept unchanged when the pressure centering plate slides along the catheter body.
Preferably, the expansion piece fixed connection in the face of sealed adapter board placed in middle, the expansion piece placed in middle is the form of buckling, and its direction of buckling is towards the inner wall of the utricule, the expansion piece placed in middle is the elastic wire, the inner wall of utricule is the annular equidistance and arranges the symmetry and install spacing casing, the expansion piece placed in middle is kept away from one side of pressure centering board and is installed in spacing casing inside.
Preferably, a telescopic corrugated pipe is arranged between the rigid driving plate and the surface of the catheter main body, and the corrugated pipe is positioned at two sides of the ultrasonic vibration device.
Preferably, one end of the corrugated pipe is fixedly connected with the surface of the rigid driving plate in a sealing way, the other end of the corrugated pipe is fixedly connected with the surface of the catheter main body, and the middle part of the corrugated pipe is a free telescopic section.
Preferably, the centering expansion piece is an expansion plate, the surface of the rigid driving plate extends towards one side far away from the ultrasonic vibration device, the surface of the extending section of the rigid driving plate is rotationally connected with driving shafts which are mutually matched with the centering expansion piece in number, and two driven shafts are rotationally connected between the inner side surface of each centering expansion piece and the surface of the catheter main body.
Preferably, the rotation direction of the driving shaft and the driven shaft is opposite.
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 of telescopic elastic structures.
Preferably, the elastic connecting piece adopts a medical nickel-titanium memory alloy spring.
Preferably, the ultrasonic vibration device is internally 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 main body through a wire, the piezoelectric ceramic generates mechanical vibration based on a reverse piezoelectric effect, and outputs ultrasonic waves with the frequency of 20kHz-100kHz, and the ultrasonic vibration device shell is packaged by adopting medical polysulfone materials, so that the vibration conduction efficiency of the piezoelectric ceramic is ensured, and the ultrasonic vibration device has good biocompatibility and pressure resistance.
Preferably, the medium channel is externally connected with a micro-injection pump, the injection medium is normal saline, and when the medium channel is used, the injection rate and the total amount of the normal saline are accurately controlled through the micro-injection pump, so that the pressure in the bag body is stably increased, and the pressure centering plate is driven to slide.
Preferably, the injected normal saline is medical isotonic normal saline, is matched with the osmotic pressure of human blood, can reduce the damage of vascular endothelial cells caused by the difference of osmotic pressure, and is used as an ultrasonic wave conduction medium, the acoustic impedance of the normal saline is close to that of human tissues, so that the energy attenuation of ultrasonic waves in the conduction process can be effectively reduced, and the ultrasonic speckle effect is ensured.
Compared with the prior art, the invention has the beneficial effects that:
1. The concentric constraint mechanism of the pressure centering plate and the catheter main body is adopted, the geometric axis coincidence of the pressure centering plate and the catheter main body is always kept in the sliding process through the cooperative design of the rigid driving plate and the sealing adapting plate, the two side plate bodies are synchronously and equidistantly displaced along the axial direction, the expansion force generated after medium injection can be uniformly acted on the capsule body through the structural cooperation, the space position of the ultrasonic vibration device is constrained in a forced mode, the ultrasonic vibration device is always stably suspended in the center of the capsule body, the uniformity of ultrasonic energy distribution is remarkably improved, the problem of excessive concentration or insufficient local energy caused by displacement of the vibration device in the prior art is effectively solved, calcified plaques in all areas of the vascular wall can be fully crushed, meanwhile, vascular endothelial injury is avoided, and compared with the problem of single-side displacement of the vibration device caused by lack of concentric constraint of the traditional catheter, the mechanism fundamentally ensures the safety and effectiveness of treatment.
2. The linkage mechanism of the elastic wire centering expansion piece and the limiting shell is another important advantage, the high deformation characteristic of the elastic wire enables the elastic wire to adaptively adjust the bending angle and the supporting force along with the blood vessel morphology, the elastic wire can locally shrink and avoid when encountering plaque bulges in a bent blood vessel, the elastic wire moderately stretches to provide stable support at the concave side of the blood vessel, the limiting shell ensures the controllability of an expansion track by limiting the tail end of the elastic wire, the design greatly improves the adaptation capability of a catheter to complex blood vessel scenes, effectively improves the problem that the traditional rigid expansion structure easily causes deflection of a vibration device in the bent blood vessel or complex plaque environment and even damages the blood vessel wall, ensures that the catheter can still maintain symmetrical distribution of a pressure centering plate in complex lesions of which the calcium blocks are distributed more and the blood vessel is bent, and ensures the neutral position stability of the ultrasonic vibration device.
3. Aiming at the light calcification scene of a straight blood vessel, the linkage mechanism of the rigid expansion plate and the reverse shaft shows unique advantages, the reverse rotation of the driving shaft and the driven shaft forms a constraint effect of limited deflection expansion, the expansion plate can controllably deflect around the shaft while moving along with the pressure centering plate in a small amplitude, the expanding force of the capsule body is concentrated and stable, the structural cooperation obviously improves the positioning accuracy of the vibration device in the straight blood vessel, the stable radial support can be quickly established, the problem of unstable neutral position caused by the dispersion of the supporting force of the traditional elastic expansion structure is effectively solved, the secondary damage to the light calcified plaque is reduced, and compared with the defect that the stability and the safety are difficult to consider in the light calcification treatment of the straight blood vessel in the prior art, and the mechanism realizes the organic combination of accurate positioning and the mild treatment.
4. The elastic restoring force is stored through the stretching deformation of the telescopic corrugated pipe in the elastic restoring mechanism, the pressure centering plate can be driven to quickly restore after treatment is finished, the centering expansion piece is folded, the bag body collapses to restore the low profile, the blood vessel is safely withdrawn, simultaneously, the elastic characteristic of the corrugated pipe can buffer the fluctuation of the injection liquid pressure in real time, the deviation of the vibration device caused by the instant pressure change is avoided, the recycling stability of the catheter is improved by the mechanism, the pressure dip and the vascular injury risk caused by the traditional catheter depending on medium withdrawal and restoring are effectively improved, and compared with the safety defect of the prior art in the withdrawal stage of the device, the mechanism ensures the stability and the safety of the whole treatment process.
Drawings
FIG. 1 is a schematic perspective view showing a part of a main structure in a first embodiment of the present invention;
FIG. 2 is a partially disassembled perspective view of a main structure according to a first embodiment of the present invention;
FIG. 3 is a schematic perspective view of the enlarged structure of FIG. 1A according to the present invention;
FIG. 4 is a schematic partial perspective view of a main structure according to a first embodiment of the present invention;
FIG. 5 is a schematic cross-sectional perspective view of a centering stent in accordance with a first embodiment of the present invention;
FIG. 6 is a partially cut-away perspective view of a body structure in a second embodiment of the invention;
FIG. 7 is a partially disassembled perspective view of a main structure in a second embodiment of the present invention;
Fig. 8 is a schematic plan view showing a movement state of a centering expansion member, a driving shaft and a driven shaft in a second embodiment of the present invention.
In the figure:
1. The device comprises a catheter main body, a medium channel, a2 ultrasonic vibration device, a3 balloon, a 4 pressure centering plate, a 401 rigid driving plate, a 402 sealing adapting plate, a 41 centering expansion piece, a 42 limiting shell, a 43, a corrugated pipe, a 44, a driving shaft, a 45, a driven shaft, a 46 and an elastic connecting piece.
Detailed Description
The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to fall within the scope of the invention.
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, the external sealing protrusion, the external sealing groove and the medical silica gel sealing strip only provide the function of sliding sealing, and the working principle and the specific structure of the above structure are all the prior art, so in view of the universality of the above structure, the specific principle is not repeated in the following.
Referring to fig. 1 to 5, an inflation catheter for an inflation balloon includes a catheter body 1, an ultrasonic vibration device 2 is installed on the surface of the catheter body 1, two sides of the surface of the catheter body 1 are fixedly connected with a balloon 3, only two sides of the balloon 3 are fixed with the catheter body 1, a middle area is a deformable free section, two sides of the ultrasonic vibration device 2 are provided with a pressure centering plate 4, the pressure centering plate 4 is slidably connected to the surface of the catheter body 1, the pressure centering plate 4 is located in the deformable free section of the balloon 3, a plurality of centering expansion members 41 are linearly distributed between one side of the surface of the pressure centering plate 4 facing the inner wall of the balloon 3 and the inner wall of the balloon 3 at equal intervals, a medium channel 11 is arranged in the catheter body 1, and the medium channel 11 is communicated with a space surrounded by the balloon 3 and the pressure centering plate 4.
It should be noted that, the pressure middle plate 4 is composed of a rigid driving plate 401 and a sealing adapting plate 402, the rigid driving plate 401 is connected to the surface of the catheter main body 1 in a sealing sliding manner, the edge of the sealing adapting plate 402 is attached to the inner wall of the balloon body 3, and the sealing adapting plate 402 is in sliding sealing fit with the balloon body 3, when the pressure middle plate 4 slides along the catheter main body 1, the sealing adapting plate 402 moves synchronously with the rigid driving plate 401, the edge of the sealing adapting plate always keeps sealing contact with the inner wall of the balloon body 3, the inner wall of the balloon body 3 corresponds to the sliding path of the sealing adapting plate 402, an external sealing groove is circumferentially arranged, an external sealing bulge matched with the external sealing groove is arranged at the edge of the sealing adapting plate 402, and meanwhile, a medical silica gel sealing strip is embedded at the outer side of the external sealing bulge, so that the edge of the sealing adapting plate 402 always keeps sealing contact with the inner wall of the balloon body 3 to prevent medium leakage, the pressure centering plate 4 is integrally arranged concentrically with the catheter main body 1, the geometric central axis of the pressure centering plate 4 coincides with the central axis of the catheter main body 1, when the pressure centering plate 4 slides along the catheter main body 1, the concentric state of the pressure centering plate 4 is kept unchanged, the centering expansion piece 41 is fixedly connected to the surface of the sealing adapting plate 402, the centering expansion piece 41 is in a bent shape, the bending direction of the centering expansion piece 41 faces the inner wall of the capsule body 3, the centering expansion piece 41 is elastic wires, the inner wall of the capsule body 3 is symmetrically provided with a limiting shell 42 in annular equidistant arrangement, one side of the centering expansion piece 41 far away from the pressure centering plate 4 is arranged in the limiting shell 42, a telescopic corrugated pipe 43 is arranged between the rigid driving plate 401 and the surface of the catheter main body 1, the corrugated pipe 43 is positioned on two sides of the ultrasonic vibration device 2, one end of the corrugated pipe 43 is fixedly connected with the surface of the rigid driving plate 401 in a sealing way, the other end of the corrugated pipe 43 is fixedly connected with the surface of the catheter main body 1, the middle part of bellows 43 is the free expansion segment, the built-in piezoceramics transducer of ultrasonic vibration device 2, when outside ultrasonic generator passes through the wire and presets the circuit along pipe main part 1 inside and applys high frequency electric signal to the transducer, piezoceramics produces mechanical vibration based on contrary piezoelectricity effect, output frequency is 20kHz-100 kHz's ultrasonic wave, ultrasonic vibration device 2 shell adopts medical polysulfone material encapsulation, both ensure piezoceramics's vibration conduction efficiency, possess good biocompatibility and withstand voltage, medium passageway 11 external micro-injection pump, the injection medium is normal saline, when using, the injection rate and the total amount of normal saline are accurately controlled through micro-injection pump, make the stable rising of pressure in the bag body 3, drive pressure is the normal saline of medical isotonic water in the middle plate 4 slip, match with human blood osmotic pressure, can reduce vascular endothelial cells and because of the damage that osmotic pressure difference produced, and normal saline is as the ultrasonic wave conduction medium, its impedance is close with human tissue, can effectively reduce the energy attenuation of ultrasonic wave speckle in the conduction process, ensure the effect of ultrasonic breaking.
Specifically, in clinical operation, after the catheter main body 1 is delivered to the lesion site through the vascular interventional path, the position is confirmed under the imaging device by the developing mark (usually an embedded medical developing ring) at the front end of the catheter main body 1, so that the ultrasonic vibration device 2 is ensured to be aligned with the calcified plaque region, the balloon 3 is in an unexpanded state, the pressure centering plate 4 keeps an initial position under the natural elastic force of the corrugated tube 43, the elastic wire of the centering expansion piece 41 is in a natural bending state, and the whole structure is attached to the surface of the catheter main body 1, so that flexible delivery in the blood vessel is facilitated.
When the treatment is started, the medical isotonic normal saline is injected into the closed space surrounded by the capsule body 3 and the pressure centering plate 4 through the medium channel 11 by the external micro-infusion pump, the pressure in the closed space is gradually increased along with the continuous injection of the normal saline, and the pressure centering plate 4 on two sides is pushed to synchronously slide along the axial direction of the catheter main body 1 in a direction away from the ultrasonic vibration device 2.
Because the pressure centering plate 4 and the catheter main body 1 are kept concentrically, the geometric central axis of the pressure centering plate is always coincident with the central axis of the catheter main body 1, the sliding distance of the pressure centering plates 4 at two sides is completely symmetrical, the offset risk caused by single-side stress is avoided, and a foundation is laid for the neutral position maintenance of the ultrasonic vibration device 2.
In the sliding process of the pressure centering plate 4, the sealing adapting plate 402 moves synchronously with the rigid driving plate 401, the external sealing bulge at the edge of the sealing adapting plate is precisely matched with the external sealing groove on the inner wall of the bag body 3, the embedded medical silica gel sealing strip is tightly attached to the inner wall of the groove all the time by virtue of elastic deformation, a dynamic sealing barrier is formed, the physiological saline is ensured to be fully used for driving the expansion action without leakage, and meanwhile, the sealing sliding connection of the rigid driving plate 401 and the catheter main body 1 further strengthens the sealing performance of the system, so that the pressure conduction efficiency is maximized.
Along with the sliding of the pressure centering plate 4, the elastic wire of the centering expansion piece 41 fixed between the surface of the sealing adapting plate 402 and the limiting shell 42 is extruded, and the elastic wire synchronously pushes the deformable free section of the capsule body 3 outwards under the action of the extrusion force, so that the capsule body 3 starts to expand uniformly from the middle area.
In this process, the expansion force of the elastic wires on both sides is transferred to the catheter main body 1 through the pressure centering plate 4 to form symmetrical radial supporting force, so that the catheter main body 1 and the ultrasonic vibration device 2 on the surface are stably suspended in the center of the blood vessel, and the neutral position is maintained.
When the balloon 3 expands to lightly touch the vessel wall, physiological saline is filled between the balloon 3 and the ultrasonic vibration device 2 to form a liquid cushion layer, and at the moment, the ultrasonic vibration device 2 starts to work.
The external ultrasonic generator inputs high-frequency electric signals to the built-in piezoelectric ceramic transducer through the lead, the piezoelectric ceramic generates mechanical vibration based on the inverse piezoelectric effect, the output ultrasonic waves are uniformly transmitted to calcified plaques of the vascular wall through the physiological saline cushion layer, and as the ultrasonic vibration device 2 is positioned at the neutral position, the ultrasonic waves emitted by the ultrasonic vibration device are uniformly transmitted to the periphery, the energy distribution is uniform, and the vascular damage caused by local energy is effectively avoided or the plaque breakage caused by insufficient energy is not thorough.
In the treatment process, if the blood vessel morphology has slight bending or uneven plaque distribution, the elastic deformation characteristic of the centering expansion piece 41 (elastic wire) can play a self-adaptive regulation role, when the pressure of the blood vessel wall at one side is increased, the elastic wire at the corresponding side can absorb the pressure through slight contraction, and the opposite side elastic wire keeps supporting force, the pressure centering plate 4 is ensured to be symmetrically distributed around the central axis of the catheter main body 1 all the time through the dynamic balance, and then the neutral position of the ultrasonic vibration device 2 is maintained, meanwhile, the corrugated tube 43 slides along with the pressure centering plate 4 to generate stretching deformation, the stored elastic restoring force can buffer the pressure fluctuation in real time, and the device deflection caused by the instant change of the injection pressure is avoided.
After the treatment is finished, the micro liquid injection pump stops injecting liquid and slowly pumps back physiological saline, the pressure in the closed space is reduced, the elastic restoring force of the corrugated pipe 43 drives the pressure centering plate 4 to reset, the centering expansion piece 41 (elastic wire) contracts back to an initial bending state under the action of self elastic force, the bag body 3 collapses along with the centering expansion piece, and the whole device restores to a low-profile state, so that the blood vessel can be safely withdrawn.
It should be noted that, because the centering expansion piece 41 adopts an elastic wire structure, the elastic wire structure has excellent deformability and elastic restoring capability, and has more advantages when facing complex pathological change scenes with more calcium block distribution and bending of blood vessels, the elastic wire can adaptively adjust bending angles and supporting forces along with the shape of the bent blood vessels, and avoid the calcified plaque bulge, and provide stable support on the concave side of the bending of the blood vessels through partial contraction and moderate extension, thereby avoiding excessive compression of the rigid structure on the blood vessel walls, and always maintaining symmetrical distribution of the pressure centering plate 4 in complex forms, ensuring that the neutral position of the ultrasonic vibration device 2 is not influenced by the bending of the blood vessels or uneven distribution of the plaque, and further realizing safe and effective ultrasonic plaque breaking treatment in complex vascular environments.
In the second embodiment, as shown in fig. 6 to 8, the centering expansion members 41 are expansion plates, the surface of the rigid driving plate 401 extends toward the side far away from the ultrasonic vibration device 2, the surface of the extending section of the rigid driving plate 401 is rotatably connected with driving shafts 44 which are mutually adapted to the number of the centering expansion members 41, and two driven shafts 45 are rotatably connected between the inner side surface of each centering expansion member 41 and the surface of the catheter main body 1.
It should be noted that, the rotation directions of the driving shaft 44 and the driven shaft 45 are opposite, a plurality of elastic connecting pieces 46 are installed between the opposite surfaces of the two rigid driving plates 401, the elastic connecting pieces 46 are telescopic elastic structures, and the elastic connecting pieces 46 are medical nickel-titanium memory alloy springs.
Specifically, on the basis of the first embodiment, as the physiological saline is filled, the pressure in the space of the balloon 3 gradually rises, and the rigid driving plates 401 on both sides are pushed to be axially and synchronously away from the ultrasonic vibration device 2 along the catheter main body 1.
In the pressure transmission process, when the rigid driving plate 401 slides, the driving shaft 44 on the surface of the extending section starts to rotate under the action of thrust, and the driving shaft 44 and the driven shaft 45 form reverse linkage constraint because the driving shaft 44 and the driven shaft 45 rotate in opposite directions, wherein the driving shaft 44 tries to push the centering expansion piece 41 (expansion plate) to be unfolded outwards greatly, but the driven shaft 45 on the inner side of the expansion plate is restrained by the surface of the catheter main body 1, and the excessive displacement of the expansion plate is limited.
Under the constraint, the expansion plate can only slightly move along with the pressure centering plate 4, and meanwhile, due to the reverse rotation of the driving shaft 44 and the driven shaft 45, the expansion plate controllably deflects around the shaft, namely, when the driving shaft 44 rotates clockwise, the driven shaft 45 rotates anticlockwise, so that the expansion plate is forced to push towards the inner wall of the bag body 3.
The linkage mechanism of limited deflection and expansion ensures that the expansion plates distributed in the circumferential direction are synchronously expanded towards the inner wall of the capsule body 3, and the deformable free section of the capsule body 3 is pushed to expand uniformly.
Because the expansion plate is of a rigid structure, the acting force on the capsule body 3 in the expanding process is more concentrated and controllable, and the formed radial supporting force is transmitted to the catheter main body 1 through the pressure centering plate 4, so that the ultrasonic vibration device 2 is stably suspended in the center of a blood vessel, and the neutral position is maintained.
When the capsule body 3 expands to be in contact with the blood vessel wall, physiological saline forms a uniform medium layer between the capsule body 3 and the ultrasonic vibration device 2, the ultrasonic vibration device 2 starts to work, the external ultrasonic generator drives the piezoelectric ceramic transducer through a lead, the output ultrasonic waves uniformly act on calcified plaques through the physiological saline layer, the ultrasonic waves are uniformly spread to the periphery due to the fact that the ultrasonic vibration device 2 is located at a neutral position, the energy distribution is uniform, and vascular damage or plaque breakage failure caused by local overhigh/insufficient energy is avoided.
It should be noted that, compared with the first embodiment, the rigid expansion plate and reverse shaft linkage structure of the present embodiment is more suitable for the scene with small calcified plaque volume and straighter blood vessel morphology, because the supporting force of the rigid expansion plate is concentrated, a stable neutral position can be quickly established, and the rigid expansion plate is suitable for accurate positioning in a straight blood vessel, and secondly, the reverse shaft linkage 'small amplitude deflection + expansion' is more uniform for extruding the blood vessel wall, so that the secondary damage of elastic deformation to the mild calcified plaque can be reduced, and finally, if the blood vessel has bending or calcified plaque is complicated, the deflection of the rigid expansion plate is limited, and the support imbalance is easily caused, but under the straight blood vessel and the light calcified scene, the stability and the accuracy of the rigid expansion plate are obviously better than those of the elastic wire structure.
After the treatment is finished, the micro-infusion pump pumps back physiological saline, the elastic connecting piece 46 releases elastic potential energy, the rigid driving plate 401 is pulled to reset, the driving shaft 44 and the driven shaft 45 rotate reversely, the expansion plate is driven to be folded and attached to the catheter main body 1, the bag body 3 collapses to restore a low section, and the blood vessel is conveniently and safely withdrawn.
It is noted that relational terms such as first and second, and the like are used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Moreover, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising one does not exclude the presence of other like elements in a process, method, article, or apparatus that comprises an element.
Although embodiments of the present 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 therein without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.
Claims (8)
1. The vibration wave balloon dilation catheter comprises a catheter main body (1), wherein an ultrasonic vibration device (2) is arranged on the surface of the catheter main body (1), balloon bodies (3) are fixedly connected to two sides of the surface of the catheter main body (1), the balloon bodies (3) are only fixed to the catheter main body (1) at two sides, and a deformable free section is arranged in the middle area, and the vibration wave balloon dilation catheter is characterized in that pressure centering plates (4) are arranged on two sides of the ultrasonic vibration device (2), the pressure centering plates (4) are slidably connected to the surface of the catheter main body (1), the pressure centering plates (4) are located in deformable free sections in the balloon bodies (3), a plurality of centering dilation pieces (41) are linearly distributed and arranged between one side, facing the inner wall of the balloon bodies (3), of the surface of the pressure centering plates (4), and a medium channel (11) is arranged in the catheter main body (1), and is communicated with a space surrounded by the balloon bodies (3) and the pressure centering plates (4);
The pressure centering plate (4) consists of a rigid driving plate (401) and a sealing adapting plate (402), the rigid driving plate (401) is connected to the surface of the catheter main body (1) in a sealing sliding manner, the edge of the sealing adapting plate (402) is attached to the inner wall of the balloon body (3), the sealing adapting plate (402) is in sliding sealing fit with the balloon body (3), and when the pressure centering plate (4) slides along the catheter main body (1), the sealing adapting plate (402) moves synchronously along with the rigid driving plate (401), and the edge of the sealing adapting plate always keeps sealing contact with the inner wall of the balloon body (3);
The pressure centering plate (4) is integrally arranged concentrically with the catheter main body (1), the geometric central axis of the pressure centering plate (4) coincides with the central axis of the catheter main body (1), and the concentric state of the pressure centering plate (4) is kept unchanged when the pressure centering plate (4) slides along the catheter main body (1).
2. The vibrating wave balloon dilation catheter of claim 1, wherein the centering dilation piece (41) is fixedly connected to the surface of the sealing adapting plate (402), the centering dilation piece (41) is bent, the bending direction of the centering dilation piece faces to the inner wall of the balloon body (3), the centering dilation piece (41) is elastic wires, limit shells (42) are symmetrically arranged on the inner wall of the balloon body (3) in an annular equidistant arrangement mode, and one side, far away from the pressure centering plate (4), of the centering dilation piece (41) is arranged inside the limit shells (42).
3. The vibrating balloon dilation catheter according to claim 2 wherein a retractable bellows (43) is mounted between the rigid drive plate (401) and the surface of the catheter body (1), the bellows (43) being located on either side of the ultrasonic vibration device (2).
4. The vibrating wave balloon dilation catheter of claim 3, wherein one end of the corrugated tube (43) is fixedly connected with the surface of the rigid driving plate (401) in a sealing way, the other end of the corrugated tube is fixedly connected with the surface of the catheter main body (1), and the middle part of the corrugated tube (43) is a free telescopic section.
5. The vibrating balloon dilation catheter according to claim 1 is characterized in that the centering dilators (41) are dilation plates, the surface of the rigid driving plate (401) extends towards the side far away from the ultrasonic vibration device (2), driving shafts (44) which are mutually matched with the centering dilators (41) in number are rotatably connected to the extending section surface of the rigid driving plate (401), and two driven shafts (45) are rotatably connected between the inner side surface of each centering dilator (41) and the surface of the catheter main body (1).
6. A vibrating balloon dilation catheter according to claim 5 wherein the drive shaft (44) and driven shaft (45) are rotated in opposite directions.
7. The balloon dilation catheter of claim 5 wherein a plurality of resilient connectors (46) are mounted between opposing surfaces of the rigid drive plates (401), the resilient connectors (46) being of a telescoping resilient construction.
8. The balloon dilation catheter of claim 7 wherein the resilient connector (46) is a medical nickel-titanium memory alloy spring.
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN117815521A (en) * | 2024-01-22 | 2024-04-05 | 广州启骏生物科技有限公司 | Balloon dilation catheter and operation monitoring device thereof |
| CN119497597A (en) * | 2022-07-12 | 2025-02-21 | 波士顿科学国际有限公司 | Cutting and Scoring Lithotripsy Balloon Catheters |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| US8827953B2 (en) * | 2013-01-15 | 2014-09-09 | Krishna Rocha-Singh | Apparatus and method for delivering intraluminal therapy |
| WO2015073114A1 (en) * | 2013-11-13 | 2015-05-21 | West Coast Catheter, Inc. | Flexible high-pressure balloons |
| CN106725838B (en) * | 2016-02-11 | 2024-03-29 | 上海魅丽纬叶医疗科技有限公司 | Catheter with balloon dilation and radio frequency ablation functions and ablation method thereof |
| CN115414577B (en) * | 2022-08-18 | 2023-09-26 | 广东博迈医疗科技股份有限公司 | Medicine sacculus pipe |
| CN221980818U (en) * | 2023-12-30 | 2024-11-12 | 深圳信立泰医疗器械股份有限公司 | Shock wave balloon catheter |
| CN222604628U (en) * | 2024-02-28 | 2025-03-14 | 上海佳沐垚医疗科技有限公司 | Ultrasonic balloon recanalization catheter |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN119497597A (en) * | 2022-07-12 | 2025-02-21 | 波士顿科学国际有限公司 | Cutting and Scoring Lithotripsy Balloon Catheters |
| CN117815521A (en) * | 2024-01-22 | 2024-04-05 | 广州启骏生物科技有限公司 | Balloon dilation catheter and operation monitoring device thereof |
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