CN114027926A - Intravascular calcified plaque impact fracture device - Google Patents
Intravascular calcified plaque impact fracture device Download PDFInfo
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- CN114027926A CN114027926A CN202111279537.2A CN202111279537A CN114027926A CN 114027926 A CN114027926 A CN 114027926A CN 202111279537 A CN202111279537 A CN 202111279537A CN 114027926 A CN114027926 A CN 114027926A
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B17/22004—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
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- A—HUMAN NECESSITIES
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- 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
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1002—Balloon catheters characterised by balloon shape
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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
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/104—Balloon catheters used for angioplasty
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- A—HUMAN NECESSITIES
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- A61B17/22004—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
- A61B2017/22005—Effects, e.g. on tissue
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- A—HUMAN NECESSITIES
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- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1079—Balloon catheters with special features or adapted for special applications having radio-opaque markers in the region of the balloon
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Abstract
The invention provides an intravascular calcified plaque impact fracture device which comprises a balloon catheter, an ultrasonic transducer and a balloon arranged on the balloon catheter, wherein the ultrasonic transducer comprises a first conductive lead, a second conductive lead and an annular body which is arranged in the balloon and sleeved on the balloon catheter; the annular body comprises a first annular electrode layer, a piezoelectric effect layer and a second annular electrode layer, the first annular electrode layer is located on the radial inner side, the second annular electrode layer is located on the radial outer side, the piezoelectric effect layer is located between the first annular electrode layer and the second annular electrode layer, the piezoelectric effect layer comprises a plurality of piezoelectric ceramic parts and a plurality of polymer parts without piezoelectricity, and the polymer parts and the piezoelectric ceramic parts are distributed at intervals in the circumferential direction of the annular body. The intravascular calcified plaque impact fracture device can better realize the intravascular calcified plaque impact fracture effect, break the stress ring on a calcified plate and facilitate the development of balloon angioplasty and stent implantation.
Description
Technical Field
The invention relates to the technical field of medical equipment, in particular to an intravascular calcified plaque impact fracture device.
Background
Vascular calcification is a common pathological manifestation of atherosclerosis, hypertension, diabetic vasculopathy, vascular injury, chronic kidney disease, aging and the like.
For the treatment of vascular calcification, the prior art provides a way of treating calcification with an ultrasonic balloon, which specifically includes the following steps: the ultrasonic balloon coated with the preset air microbubble coating on the outer surface is delivered to a diseased region and then is expanded to enable the balloon to be in contact with diseased tissue, ultrasonic waves are applied through an ultrasonic transducer in the balloon, sulfur hexafluoride air bubbles in the preset air microbubble coating generate a cavitation effect under the action of the ultrasonic transducer, the cavitation effect enables the air bubbles to explode, and calcified plaques on the inner wall of a blood vessel are smashed. Clearly, the therapeutic effect of this prior art technique needs to rely on a pre-placed coating of air microbubbles on the outer surface of the balloon.
Disclosure of Invention
In view of the above-mentioned situation, a main object of the present invention is to provide an intravascular calcified plaque impact fracturing device which can achieve a better intravascular calcified plaque impact fracturing effect.
In order to achieve the purpose, the technical scheme of the invention provides an intravascular calcified plaque impact fracture device which comprises a balloon catheter, an ultrasonic transducer and a balloon arranged on the balloon catheter, wherein the ultrasonic transducer comprises a first conductive lead, a second conductive lead and an annular body which is arranged in the balloon and sleeved on the balloon catheter;
the annular body comprises a first annular electrode layer, a piezoelectric effect layer and a second annular electrode layer, the first annular electrode layer is positioned on the radial inner side, the second annular electrode layer is positioned on the radial outer side, the piezoelectric effect layer is positioned between the first annular electrode layer and the second annular electrode layer, the piezoelectric effect layer comprises a plurality of piezoelectric ceramic parts and a plurality of polymer parts without piezoelectricity, and the polymer parts and the piezoelectric ceramic parts are distributed at intervals in the circumferential direction of the annular body, so that the piezoelectric ceramic parts are separated from each other in the circumferential direction of the annular body;
the first conductive lead is electrically connected with the first annular electrode layer, the second conductive lead is electrically connected with the second annular electrode layer, and the first conductive lead and the second conductive lead are used for applying voltage between the first annular electrode layer and the second annular electrode layer to enable the annular body to generate ultrasonic waves in the radial direction of the balloon catheter.
Further, the first and/or second electrically conductive leads are disposed along the balloon catheter and at a surface of the balloon catheter;
the annular body is further provided with a first connecting terminal electrically connected with the first annular electrode layer, the first connecting terminal is arranged at a position close to the polymer part and extends along the axial direction of the balloon catheter, and the first conductive lead is electrically connected with the first annular electrode layer through the second connecting terminal;
the annular body is further provided with a second wiring terminal electrically connected with the second annular electrode layer, the second wiring terminal is arranged at a position close to the polymer part and extends along the radial direction of the balloon catheter, and the second conductive lead is electrically connected with the second annular electrode layer through the second wiring terminal.
Further, on the annular end face of the piezoelectric effect layer, the area of the plurality of piezoelectric ceramic parts is 40% to 90% of the total area of the annular end face.
Further, the balloon comprises a cylindrical middle part after being inflated and a conical end part after being inflated, and the annular body is positioned in the middle part.
Further, the piezoelectric effect layer is pressed by the first annular electrode layer formed on the inner side of the piezoelectric effect layer by cooling press-fitting and the second annular electrode layer formed on the outer side of the piezoelectric effect layer by hot press-fitting.
Further, the material of the polymer part comprises at least one of polytetrafluoroethylene and epoxy resin, the material of the piezoelectric ceramic part comprises at least one of PZT 4, PZT 5 and PZT8, and the material of the first annular electrode layer and the second annular electrode layer comprises at least one of steel, copper and aluminum.
Further, the sacculus pipe includes inner tube and outer tube, the outer pipe box is established the periphery of inner tube, just the inner tube with there is the annular chamber that is used for to carry the developer between the outer tube the inside of sacculus, the open position of sacculus is sealed on the outer tube, and is located there is the disappearance district of outer tube in the periphery of the inner tube in the sacculus, so that the annular chamber with the inside intercommunication of sacculus, cyclic annular body cover is established and is located on the inner tube in disappearance district.
Furthermore, the balloon catheter comprises an inner tube, the opening position of the balloon is sealed on the inner tube, a through hole is formed in the inner tube in the balloon, so that the inner tube is communicated with the inside of the balloon, and the annular body is sleeved on the inner tube in the balloon.
Further, the device is used for human coronary artery, and the device comprises two annular bodies distributed along the axial direction of the balloon catheter.
Further, the device is used for a peripheral artery of a human body and comprises three annular bodies distributed along the axial direction of the balloon catheter.
The invention provides an intravascular calcified plaque impact fracture device, wherein an ultrasonic transducer arranged in a balloon comprises an annular body sleeved on a balloon catheter, the annular body comprises a first annular electrode layer, a piezoelectric effect layer and a second annular electrode layer, and can emit ultrasonic waves in different radial directions of the balloon catheter, after the balloon is sent to a lesion part, the annular body of the ultrasonic transducer can generate the ultrasonic waves to plaques at different positions on the periphery of the annular body, the piezoelectric effect layer of the ultrasonic transducer comprises a plurality of polymer parts and a plurality of piezoelectric ceramic parts, the polymer parts and the piezoelectric ceramic parts are distributed at intervals in the circumferential direction of the annular body, and by the piezoelectric composite design mode, the transverse coupling of the piezoelectric ceramic in the piezoelectric effect layer can be reduced, the electromechanical conversion efficiency of the piezoelectric effect layer in the radial direction of the annular body is increased, namely, the energy loss caused by axial vibration is favorably reduced, increase the ascending ultrasonic energy of radial direction, simultaneously, the polymer portion can reduce the whole acoustic resistance of cyclic annular body, can make more ultrasonic energy pass into the developer in the sacculus and act on calcified plaque like this, can smash calcified plaque under the combined action of the cavitation bubble that ultrasonic cavitation effect produced, and then can be better realize endovascular calcified plaque impact fracture effect, break the stress ring on the calcified plate, be convenient for carry out sacculus plasty and stent implantation, and be favorable to reducing the reliance to the special coating on the sacculus surface (like the air microbubble coating among the prior art), can not even need not to add this kind of special coating again on the surface of sacculus.
Drawings
Preferred embodiments according to the present invention will be described below with reference to the accompanying drawings. In the figure:
FIG. 1 is a schematic view of an intravascular calcified plaque blast breaking device delivered into a blood vessel according to an embodiment of the present invention;
FIG. 2 is an exploded view of an intravascular calcified plaque blast fracturing device provided by an embodiment of the present invention;
FIG. 3 is a schematic diagram of an annular body of an ultrasonic transducer according to an embodiment of the present invention;
FIG. 4 is a schematic view of a piezoelectric effect layer in the annular body shown in FIG. 3;
FIG. 5 is a schematic view of a first annular electrode layer in the annular body shown in FIG. 3;
FIG. 6 is a schematic view of a second annular electrode layer in the annular body shown in FIG. 3;
fig. 7 is a schematic diagram of an operation of an ultrasonic transducer according to an embodiment of the present invention.
Detailed Description
The present invention will be described below based on examples, but the present invention is not limited to only these examples. In the following detailed description of the present invention, certain specific details are set forth in order to avoid obscuring the nature of the present invention, well-known methods, procedures, and components have not been described in detail.
Further, those of ordinary skill in the art will appreciate that the drawings provided herein are for illustrative purposes and are not necessarily drawn to scale.
Unless the context clearly requires otherwise, throughout the description and the claims, the words "comprise", "comprising", and the like are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense; that is, what is meant is "including, but not limited to".
In the description of the present invention, it is to be understood that the terms "first," "second," and the like are used for descriptive purposes only and are not to be construed as indicating or implying relative importance. In addition, in the description of the present invention, "a plurality" means two or more unless otherwise specified.
Referring to fig. 1 and 2, the intravascular calcified plaque impact fracture device provided by the embodiment of the present invention includes a balloon catheter 20, a balloon 30 disposed on the balloon catheter 20, and an ultrasonic transducer, where the ultrasonic transducer is a piezoelectric transducer and includes a first conductive lead, a second conductive lead, and an annular body 50 disposed inside the balloon 30 and sleeved on the balloon catheter 20, for example, the annular body is in a circular ring shape;
referring to fig. 3 to 6, the annular body 50 includes a first annular electrode layer 51, a piezoelectric effect layer 52 and a second annular electrode layer 53, the first annular electrode layer 51 is located at the radial inner side of the annular body 50, the second annular electrode layer 53 is located at the radial outer side of the annular body 50, the piezoelectric effect layer 52 is located between the first annular electrode layer 51 and the second annular electrode layer 53, the piezoelectric effect layer 53 is also in a corresponding annular shape, and includes a plurality of piezoelectric ceramic portions 52a and a plurality of polymer portions 52b without piezoelectricity, and the polymer portions 52b and the piezoelectric ceramic portions 52a are distributed at intervals in the circumferential direction of the annular body 50, so that the piezoelectric ceramic portions 52a are separated from each other in the circumferential direction of the annular body 50;
for example, the piezoelectric effect layer 53 may include four polymer portions 52b having the same shape and size and four piezoelectric ceramic portions 52a having the same shape and size, where the polymer portions 52b and the piezoelectric ceramic portions 52a are distributed at intervals to form a circular structure;
the first conductive lead is electrically connected to the first annular electrode layer 51, the second conductive lead is electrically connected to the second annular electrode layer 53, and the first conductive lead and the second conductive lead are used for applying a voltage between the first annular electrode layer and the second annular electrode layer, so that the annular body generates ultrasonic waves in the radial direction of the balloon catheter 20.
The intravascular calcified plaque impact fracture device provided by the embodiment of the invention is characterized in that an ultrasonic transducer arranged in a balloon comprises an annular body sleeved on a balloon catheter, the annular body comprises a first annular electrode layer, a piezoelectric effect layer and a second annular electrode layer, and can emit ultrasonic waves in different radial directions of the balloon catheter, after the balloon is sent to a lesion part, the annular body of the ultrasonic transducer can generate the ultrasonic waves to plaques at different positions on the periphery of the annular body, the piezoelectric effect layer of the ultrasonic transducer comprises a plurality of polymer parts and a plurality of piezoelectric ceramic parts, the polymer parts and the piezoelectric ceramic parts are distributed at intervals in the circumferential direction of the annular body, and by the piezoelectric composite design mode, the transverse coupling of the piezoelectric ceramic in the piezoelectric effect layer can be reduced, the electromechanical conversion efficiency of the piezoelectric effect layer in the radial direction of the annular body is increased, namely, the energy loss caused by axial vibration is favorably reduced, increase the ascending ultrasonic energy of radial direction, simultaneously, the polymer portion can reduce the whole acoustic resistance of cyclic annular body, can make more ultrasonic energy pass into the developer in the sacculus and act on calcified plaque like this, can smash calcified plaque under the combined action of the cavitation bubble that ultrasonic cavitation effect produced, and then can be better realize endovascular calcified plaque impact fracture effect, break the stress ring on the calcified plate, be convenient for carry out sacculus plasty and stent implantation, and be favorable to reducing the reliance to the special coating on the sacculus surface (like the air microbubble coating among the prior art), can not even need not to add this kind of special coating again on the surface of sacculus.
According to the intravascular calcified plaque impact fracture device provided by the embodiment of the invention, on the first hand, the ultrasonic energy can be transmitted to calcified plaque through radial vibration by the ultrasonic transducer, so that the plaque is cracked, and a stress ring in the plaque is damaged, so that the flexibility of a blood vessel at the plaque is increased, and a stent is conveniently expanded; in the second aspect, in the vibration process of the ultrasonic transducer, cavitation bubbles are generated in a developer around the ultrasonic transducer, the cavitation bubbles are expanded at a high speed under the action of the internal and external pressure difference and are finally broken, so that surrounding liquid is driven to form micro-jet flow, the micro-jet flow can carry out secondary smashing on the surface of a patch, a large number of micro-cracks are generated, and the local stress of the patch is released; in a third aspect, the annular bodies of the ultrasonic transducers are positioned inside the balloon, so that toxic substances (such as lead in piezoelectric ceramics) in the annular bodies can be prevented from injuring human bodies.
In the present invention, the first conductive lead and the second conductive lead may be connected to an external ultrasound power supply for supplying power, for example, after the annular body 50 is delivered to a lesion site of a human body, the ultrasound power supply located outside the human body outputs a high-frequency voltage signal to a position between the first annular electrode layer and the second annular electrode layer through the first conductive lead and the second conductive lead, so that the piezoelectric effect layer 52 located between the first annular electrode layer 51 and the second annular electrode layer 53 generates a mechanical vibration in a radial direction, thereby generating an ultrasound wave, wherein in an embodiment of the present invention, the first conductive lead and/or the second conductive lead are disposed along the balloon catheter and are located on a surface of the balloon catheter.
In an embodiment of the present invention, the annular body 50 is further provided with a first connection terminal 54 electrically connected to the first annular electrode layer 51, the first connection terminal 54 is disposed at a position close to a polymer portion 52b and extends in the axial direction of the balloon catheter 20, and the first conductive lead is electrically connected to the first annular electrode layer 51 through the second connection terminal 54;
the annular body 50 is further provided with a second connection terminal 55 electrically connected to the second annular electrode layer 53, the second connection terminal 55 is disposed at a position close to a polymer portion 52b and extends in a radial direction of the balloon catheter 20, and the second conductive lead is electrically connected to the second annular electrode 53 through the second connection terminal 55, for example, the second connection terminal 55 may cover a position of the polymer portion on an annular end surface of the annular body 50.
By disposing the first connection terminal and the second connection terminal at positions close to the polymer portion, i.e., away from the piezoelectric ceramics, since the polymer portion does not have conductivity, the influence on the piezoelectric ceramics can be reduced.
In the invention, the number, size and distribution of the polymer parts all affect the performance of the ultrasonic transducer, the proportion of the piezoelectric ceramics in the whole piezoelectric effect layer is different, and the acoustic impedance and energy density of the whole piezoelectric effect layer are also different, and it can be understood that the larger the proportion of the piezoelectric ceramics is, the larger the acoustic impedance and energy density are.
For example, in one embodiment, on the annular end face of the piezoelectric effect layer, the occupied area of the plurality of piezoelectric ceramic parts is 40% to 90% of the total area of the annular end face, and may be, for example, 60%, 80%, or the like; for example, the polymer portion 52b and the piezoelectric ceramic portion 52a are both columnar in shape with the side surface perpendicular to the bottom surface, and thus the volume of the plurality of piezoelectric ceramic portions is 40% to 90% of the total volume of the piezoelectric effect layer, so that acoustic impedance and energy density of the entire piezoelectric effect layer can be satisfied, and a large amount of ultrasonic energy can be applied to the calcified plaque.
In addition, the intravascular calcified plaque impact fracture device of the present invention may further include a developing unit 40 disposed inside the balloon 30, for example, the developing unit 40 may also be in a corresponding ring shape and fit on the balloon catheter 30, the position of the balloon can be observed through the developing unit 40, the balloon is positioned in the target treatment area, and then a developer is delivered into the balloon 30 through the balloon catheter 20, the balloon can be inflated by the developer, at least a portion of the inflated balloon can be closely attached to a heart valve or a blood vessel with calcific lesions, and in addition, the inflated and expanded condition of the balloon can be observed through the developer, preferably, in an embodiment of the present invention, the balloon 30 includes a cylindrical middle portion and a conical end portion after inflation, wherein the ring-shaped body 50 is located in the middle portion thereof, the developing unit 40 may be located at the end portion thereof, and when the balloon 30 is inflated, the cylindrical middle part of the annular body is tightly attached to the calcified plaque in the target treatment area, so that the ultrasonic energy generated by the annular body and the micro-jet formed by cavitation bubbles can better act on the calcified plaque.
For example, referring to fig. 7, when the balloon 30 is delivered to a target treatment area in a human blood vessel 10 and filled with a developer, the outer surface of the balloon 30 is closely attached to a calcified plaque 11 in the blood vessel, the annular body 50 of the ultrasonic transducer is connected to an external ultrasonic power supply through a first conducting wire and a second conducting wire on the surface of the balloon catheter 20 to generate ultrasonic vibration, and the vibration energy is transmitted to the calcified plaque 11 through the developer in the balloon 30, so that a large number of microcracks are generated on the plaque. Meanwhile, the high-frequency piezoelectric ultrasound generates cavitation bubbles 60 on the interface between the annular body 50 and the developer, the bubbles expand at a high speed under the action of the internal and external pressure difference and break finally, surrounding liquid is driven to form micro-jet, and the calcified plaque 11 is further smashed.
Wherein the ultrasound generated by the ring-shaped body 50 is refracted and reflected while propagating on the interface between the piezoelectric ceramic and the developer. Due to the large difference in acoustic impedance between the piezoelectric ceramic and the developer, most of the energy is reflected back by the interface, and only a small amount of energy enters the developer and eventually acts on calcified plaque. The piezoelectric composite material which is arranged at intervals of the piezoelectric ceramic and the polymer is adopted, so that on one hand, the energy loss caused by axial vibration can be reduced; on the other hand, the overall acoustic resistance of the piezoelectric effect layer can be reduced, so that more energy is transmitted into the developer and acts on the calcified plaque.
In the present invention, the polymer portion 52b has no piezoelectricity, and may be made of a polymer material having no piezoelectricity, for example, the material of the polymer portion 52b in the embodiment of the present invention may include at least one of polytetrafluoroethylene and epoxy resin;
the material of the piezoceramic segment 52a may include at least one of PZT 4, PZT 5, and PZT8, and the material of the first and second annular electrode layers may include at least one of steel, copper, and aluminum.
Preferably, in the embodiment of the present invention, in order to further increase the energy density of the ultrasonic transducer, in the annular body 50, the piezoelectric effect layer is pressed by the first annular electrode layer formed on the inner side of the piezoelectric effect layer by being pressed in by cooling and the second annular electrode layer formed on the outer side of the piezoelectric effect layer by being pressed in by heating.
For example, the first annular electrode layer and the second annular electrode layer are both thin-walled stainless steel rings, wherein the outer steel ring serving as the second annular electrode layer is sleeved outside the annular piezoelectric effect layer in a hot pressing mode, the inner steel ring serving as the first annular electrode layer is pressed inside the annular piezoelectric effect layer in a cooling mode, and the inner steel ring and the outer steel ring both generate extrusion force on the annular piezoelectric effect layer, so that the energy density of the piezoelectric ceramic is improved, and meanwhile, the inner steel ring and the outer steel ring also serve as electrodes.
In the present invention, the balloon catheter 20 is used for delivering the developer to the inside of the balloon 30, for example, in an embodiment, the balloon catheter 20 may include an inner tube and an outer tube, the outer tube is sleeved on the periphery of the inner tube, an annular cavity for delivering the developer to the inside of the balloon is arranged between the inner tube and the outer tube, the opening position of the balloon is sealed on the outer tube, the periphery of the inner tube in the balloon has a missing region of the outer tube, so that the annular cavity is communicated with the inside of the balloon, and the annular body is sleeved on the inner tube in the missing region.
For example, in another embodiment, the balloon catheter 20 may only include an inner tube, the opening of the balloon 30 is sealed on the inner tube, and there is a through hole on the inner tube inside the balloon to communicate the inner tube with the inside of the balloon, and the annular body is sleeved on the inner tube inside the balloon.
The intravascular calcified plaque impact fracture device provided by the embodiment of the invention is an interventional device which utilizes ultrasonic energy generated by piezoelectric efficiency of piezoelectric ceramics to break calcified plaques in a blood vessel and promote balloon expansion and stent implantation, and can break stress rings of the calcified plaques in a balloon forming operation process, so that the balloons can be smoothly expanded, and the success rate and the quality are improved.
In the embodiment of the invention, the specific size and the number of the annular bodies in the intravascular calcified plaque impact fracture device can be determined according to the part of a human body to be treated;
for example, in an embodiment of the present invention, the intravascular calcified plaque impact fracturing device is used for a human coronary artery, and may include two annular bodies distributed along the axial direction of a balloon catheter.
For example, in another embodiment of the present invention, the intravascular calcified plaque impact fracturing device is used for a peripheral artery of a human body, and may comprise three annular bodies distributed along the axial direction of a balloon catheter.
It will be appreciated by those skilled in the art that the above-described preferred embodiments may be freely combined, superimposed, without conflict.
It will be understood that the embodiments described above are illustrative only and not restrictive, and that various obvious and equivalent modifications and substitutions for details described herein may be made by those skilled in the art without departing from the basic principles of the invention.
Claims (10)
1. An intravascular calcified plaque impact fracture device comprises a balloon catheter (20), an ultrasonic transducer and a balloon (30) arranged on the balloon catheter (20), wherein the ultrasonic transducer comprises a first conductive lead, a second conductive lead and an annular body (50) which is arranged inside the balloon (30) and sleeved on the balloon catheter (20);
the annular body (50) comprises a first annular electrode layer (51), a piezoelectric effect layer (52) and a second annular electrode layer (53), the first annular electrode layer (51) is located on the radial inner side, the second annular electrode layer (53) is located on the radial outer side, the piezoelectric effect layer (52) is located between the first annular electrode layer (51) and the second annular electrode layer (53), the piezoelectric effect layer (52) comprises a plurality of piezoelectric ceramic parts (52a) and a plurality of polymer parts (52b) without piezoelectricity, and the polymer parts (52b) and the piezoelectric ceramic parts (52a) are distributed at intervals in the circumferential direction of the annular body (50), so that the piezoelectric ceramic parts (52a) are separated in the circumferential direction of the annular body (50);
the first conductive lead is electrically connected with the first annular electrode layer (51), the second conductive lead is electrically connected with the second annular electrode layer (53), and the first conductive lead and the second conductive lead are used for applying voltage between the first annular electrode layer (51) and the second annular electrode layer (53) so that the annular body (50) generates ultrasonic waves in the radial direction of the balloon catheter (20).
2. The device of claim 1, wherein the first and/or second electrically conductive leads are disposed along the balloon catheter (20) and at a surface of the balloon catheter (20);
the annular body (50) is further provided with a first connecting terminal (54) electrically connected with the first annular electrode layer (51), the first connecting terminal (54) is arranged at a position close to the polymer part (52b) and extends along the axial direction of the balloon catheter (20), and the first conductive lead is electrically connected with the first annular electrode layer (51) through the second connecting terminal (55);
the annular body (50) is further provided with a second connection terminal (55) electrically connected with the second annular electrode layer (53), the second connection terminal (55) is arranged at a position close to the polymer part (52b) and extends along the radial direction of the balloon catheter (20), and the second conductive lead is electrically connected with the second annular electrode layer (53) through the second connection terminal (55).
3. The device according to claim 1, wherein, on the annular end face of the piezoelectric effect layer (52), the area of the plurality of piezoelectric ceramic portions (52a) is 40% to 90% of the total area of the annular end face.
4. The device according to claim 1, characterized in that said balloon comprises an intermediate portion, cylindrical after inflation, and an end portion, conical after inflation, said annular body (50) being located in said intermediate portion.
5. The device according to claim 1, wherein the piezoelectric effect layer (52) is pressed by the first annular electrode layer (51) and the second annular electrode layer (53), the first annular electrode layer (51) is formed inside the piezoelectric effect layer (52) by being pressed in by cooling, and the second annular electrode layer (53) is formed outside the piezoelectric effect layer (52) by being pressed in by heat.
6. The device according to claim 1, wherein the material of the polymer part (52b) comprises at least one of polytetrafluoroethylene and epoxy resin, the material of the piezoceramic part (52a) comprises at least one of PZT 4, PZT 5, PZT8, and the material of the first and second annular electrode layers (51, 53) comprises at least one of steel, copper, and aluminum.
7. The device according to any one of claims 1 to 6, wherein the balloon catheter (20) comprises an inner tube and an outer tube, the outer tube is sleeved on the periphery of the inner tube, an annular cavity for delivering the developing solution to the inside of the balloon is arranged between the inner tube and the outer tube, the opening position of the balloon is sealed on the outer tube, the missing area of the outer tube is arranged on the periphery of the inner tube in the balloon, so that the annular cavity is communicated with the inside of the balloon, and the annular body (50) is sleeved on the inner tube in the missing area.
8. The device according to any one of claims 1 to 6, wherein the balloon catheter (20) comprises an inner tube, the opening of the balloon is sealed on the inner tube, a through hole is formed in the inner tube positioned in the balloon so that the inner tube is communicated with the inside of the balloon, and the annular body (50) is sleeved on the inner tube positioned in the balloon.
9. Device according to any one of claims 1 to 8, for use in a human coronary artery, comprising two said annular bodies (50) distributed along the axial direction of the balloon catheter (20).
10. Device according to any one of claims 1 to 8, for use in a peripheral artery of a human body, comprising three said annular bodies (50) distributed along the axial direction of the balloon catheter (20).
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202111279537.2A CN114027926A (en) | 2021-10-28 | 2021-10-28 | Intravascular calcified plaque impact fracture device |
| PCT/CN2022/112782 WO2023071427A1 (en) | 2021-10-28 | 2022-08-16 | Intravascular calcified plaque impact fracture device |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202111279537.2A CN114027926A (en) | 2021-10-28 | 2021-10-28 | Intravascular calcified plaque impact fracture device |
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| CN114027926A true CN114027926A (en) | 2022-02-11 |
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| CN202111279537.2A Pending CN114027926A (en) | 2021-10-28 | 2021-10-28 | Intravascular calcified plaque impact fracture device |
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| CN (1) | CN114027926A (en) |
| WO (1) | WO2023071427A1 (en) |
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| CN114642477A (en) * | 2022-02-25 | 2022-06-21 | 广东博迈医疗科技股份有限公司 | Blood vessel calcified plaque cutting device |
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| WO2023071427A1 (en) * | 2021-10-28 | 2023-05-04 | 嘉兴嘉创智医疗设备有限公司 | Intravascular calcified plaque impact fracture device |
| WO2023197367A1 (en) * | 2022-04-13 | 2023-10-19 | 深圳高性能医疗器械国家研究院有限公司 | Burst wave generation method for angioplasty and burst wave generation system |
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