WO2023071427A1 - Dispositif de fracture par impact de plaque calcifiée intravasculaire - Google Patents

Dispositif de fracture par impact de plaque calcifiée intravasculaire Download PDF

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Publication number
WO2023071427A1
WO2023071427A1 PCT/CN2022/112782 CN2022112782W WO2023071427A1 WO 2023071427 A1 WO2023071427 A1 WO 2023071427A1 CN 2022112782 W CN2022112782 W CN 2022112782W WO 2023071427 A1 WO2023071427 A1 WO 2023071427A1
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WIPO (PCT)
Prior art keywords
electrode layer
ring
balloon
annular
balloon catheter
Prior art date
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PCT/CN2022/112782
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English (en)
Chinese (zh)
Inventor
沈斌
Original Assignee
嘉兴嘉创智医疗设备有限公司
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Publication of WO2023071427A1 publication Critical patent/WO2023071427A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • 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
    • 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
    • A61M25/1002—Balloon catheters characterised by balloon shape
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • 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
    • A61B2017/22001—Angioplasty, e.g. PCTA
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • 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
    • A61B2017/22005—Effects, e.g. on tissue
    • A61B2017/22007—Cavitation or pseudocavitation, i.e. creation of gas bubbles generating a secondary shock wave when collapsing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • 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
    • A61B2017/22081—Treatment of vulnerable plaque
    • 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
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1075—Balloon catheters with special features or adapted for special applications having a balloon composed of several layers, e.g. by coating or embedding
    • 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
    • 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

Definitions

  • the invention relates to the technical field of medical equipment, in particular to an impact breaking device for intravascular calcified plaque.
  • Vascular calcification is a ubiquitous common pathological manifestation of atherosclerosis, hypertension, diabetic vasculopathy, vascular injury, chronic kidney disease, and aging.
  • the existing technology provides a method of treating calcification with an ultrasonic balloon, the specific method is as follows: the outer surface of the ultrasonic balloon coated with a pre-prepared air microbubble coating is delivered to the lesion and stretched , make the balloon contact with the diseased tissue, and then apply ultrasonic waves through the ultrasonic transducer inside the balloon, the sulfur hexafluoride air bubbles in the pre-set air microbubble coating will produce cavitation effect under the action of the ultrasonic transducer, The cavitation effect causes air bubbles to explode, shattering calcified plaque on the inner walls of blood vessels. Obviously, the therapeutic effect of this prior art needs to rely on the pre-set air microbubble coating on the outer surface of the balloon.
  • the main purpose of the present invention is to provide a device for impact breaking intravascular calcified plaque, which can better achieve the effect of impact breaking intravascular calcified plaque.
  • an intravascular calcified plaque impact fracture device including a balloon catheter, an ultrasonic transducer and a balloon arranged on the balloon catheter, the ultrasonic transducer
  • the device includes a first conductive lead, a second conductive lead, and an annular body disposed inside the balloon and sheathed on the balloon catheter;
  • the ring-shaped body includes a first ring-shaped electrode layer, a piezoelectric effect layer and a second ring-shaped electrode layer, the first ring-shaped electrode layer is located on the radially inner side, and the second ring-shaped electrode layer is located on the radially outer side , the piezoelectric effect layer is located between the first annular electrode layer and the second annular electrode layer, the piezoelectric effect layer includes a plurality of piezoelectric ceramic parts and a plurality of non-piezoelectric The polymer part, and the polymer part and the piezoelectric ceramic part are distributed at intervals in the circumferential direction of the annular body, so that the plurality of piezoelectric ceramic parts are in the circumferential direction of the annular body separated upwards;
  • the first conductive lead is electrically connected to the first ring-shaped electrode layer
  • the second conductive lead is electrically connected to the second ring-shaped electrode layer
  • the first conductive lead and the second conductive lead are used for A voltage is applied between the first ring-shaped electrode layer and the second ring-shaped electrode layer, so that the ring-shaped body generates ultrasonic waves in the radial direction of the balloon catheter.
  • first conductive lead and/or the second conductive lead is arranged along the balloon catheter and located on the surface of the balloon catheter;
  • the annular body is also provided with a first connection terminal electrically connected to the first ring electrode layer, the first connection terminal is arranged at a position close to the polymer part and along the balloon catheter. Extending in the axial direction, the first conductive lead is electrically connected to the first ring-shaped electrode layer through the second connection terminal;
  • the annular body is also provided with a second connection terminal electrically connected to the second ring electrode layer, the second connection terminal is arranged at a position close to the polymer part and along the balloon catheter. Extending in the radial direction, the second conductive lead is electrically connected to the second ring-shaped electrode layer through the second connection terminal.
  • the area of the plurality of piezoelectric ceramic parts is 40% to 90% of the total area of the annular end surface.
  • the balloon includes a cylindrical middle portion after expansion and a conical end portion after expansion, and the annular body is located at the middle portion.
  • the piezoelectric effect layer is pressed by the first ring-shaped electrode layer and the second ring-shaped electrode layer, and the first ring-shaped electrode layer is formed on the piezoelectric layer by cooling and pressing.
  • the inner side of the piezoelectric effect layer, and the second annular electrode layer is formed on the outer side of the piezoelectric effect layer by hot pressing.
  • the material of the polymer part includes at least one of polytetrafluoroethylene and epoxy resin
  • the material of the piezoelectric ceramic part includes at least one of PZT 4, PZT 5, and PZT8, and the first
  • the material of the first ring-shaped electrode layer and the second ring-shaped electrode layer includes at least one of steel, copper and aluminum.
  • the balloon catheter includes an inner tube and an outer tube, the outer tube is sheathed on the outer periphery of the inner tube, and there is a hole between the inner tube and the outer tube for feeding the balloon.
  • An annular cavity for conveying developing solution inside, the opening position of the balloon is sealed on the outer tube, and there is a missing area of the outer tube on the outer periphery of the inner tube in the balloon, so that the annular cavity is in contact with the outer tube.
  • the interior of the balloon communicates, and the annular body is sheathed on the inner tube located in the missing area.
  • the balloon catheter includes an inner tube, the opening position of the balloon is sealed on the inner tube, and there is a through hole on the inner tube inside the balloon, so that the inner tube and the The interior of the balloon communicates, and the annular body is sheathed on the inner tube located inside the balloon.
  • the device is used for human coronary arteries, and the device includes two annular bodies distributed along the axial direction of the balloon catheter.
  • the device is used for peripheral arteries of the human body, and the device includes three annular bodies distributed along the axial direction of the balloon catheter.
  • the ultrasonic transducer disposed inside the balloon includes a ring-shaped body sleeved on the balloon catheter, which includes a first ring-shaped electrode layer, a piezoelectric effect layer,
  • the second annular electrode layer can emit ultrasonic waves in different radial directions.
  • the annular body of the ultrasonic transducer can generate ultrasonic waves on the plaques at different positions on its periphery, and
  • the piezoelectric effect layer of the ultrasonic transducer includes multiple polymer parts and multiple piezoelectric ceramic parts. The polymer parts and piezoelectric ceramic parts are distributed at intervals in the circumferential direction of the annular body.
  • the polymer part can reduce the overall acoustic resistance of the annular body, so that more ultrasonic energy can be transmitted to the contrast agent in the balloon and act on the calcified plaque, which can be used in ultrasonic
  • the cavitation bubbles generated by the cavitation effect break down the calcified plaque, which can better achieve the impact fracture effect of the calcified plaque in the blood vessel, break the stress ring on the calcified plate, and facilitate the implementation of balloon angioplasty and stent implantation. It is beneficial to reduce the dependence on the special coating on the outer surface of the balloon (such as the air microbubble coating in the prior art), and it may even not
  • Fig. 1 is a schematic diagram of sending an intravascular calcified plaque impact breaking device into a blood vessel according to an embodiment of the present invention
  • Fig. 2 is an exploded schematic view of the intravascular calcified plaque impact breaking device provided by the embodiment of the present invention
  • FIG. 3 is a schematic diagram of an annular body of an ultrasonic transducer provided in an embodiment of the present invention.
  • Fig. 4 is a schematic diagram of a piezoelectric effect layer in the annular body shown in Fig. 3;
  • FIG. 5 is a schematic diagram of a first annular electrode layer in the annular body shown in FIG. 3;
  • FIG. 6 is a schematic diagram of a second annular electrode layer in the annular body shown in FIG. 3;
  • Fig. 7 is a working schematic diagram of the ultrasonic transducer provided by the embodiment of the present invention.
  • 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, the ultrasonic transducer
  • the transducer is a piezoelectric transducer, which includes a first conductive lead, a second conductive lead, and an annular body 50 disposed inside the balloon 30 and sheathed on the balloon catheter 20.
  • the annular body is specifically a circle ring;
  • 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 in the annular body 50, the second ring-shaped electrode layer 53 is located on the radial outside of the ring-shaped body 50, and the piezoelectric effect layer 52 is located between the first ring-shaped electrode layer 51 and the second ring-shaped electrode layer 51.
  • the piezoelectric effect layer 53 is also correspondingly ring-shaped, which includes a plurality of piezoelectric ceramic parts 52a and a plurality of non-piezoelectric polymer parts 52b, and the polymer parts 52b .
  • the piezoelectric ceramic parts 52a are distributed at intervals in the circumferential direction of the annular body 50, so that the plurality of piezoelectric ceramic parts 52a are spaced apart in the circumferential direction of the annular body 50;
  • the piezoelectric effect layer 53 may include four polymer parts 52b with the same shape and size and four piezoelectric ceramic parts 52a with the same shape and size.
  • the polymer parts 52b and the piezoelectric ceramic parts 52a are distributed at intervals to form a circular structure;
  • the first conductive lead is electrically connected to the first ring-shaped electrode layer 51
  • the second conductive lead is electrically connected to the second ring-shaped electrode layer 53
  • the first conductive lead and the second conductive lead are used for Applying a voltage between the first ring-shaped electrode layer and the second ring-shaped electrode layer causes the ring-shaped body to generate ultrasonic waves in the radial direction of the balloon catheter 20 .
  • the ultrasonic transducer disposed inside the balloon includes a ring-shaped body sleeved on the balloon catheter, which includes a first ring-shaped electrode layer, a piezoelectric effect layer and the second ring-shaped electrode layer, which can emit ultrasound in different radial directions.
  • the ring-shaped body of the ultrasound transducer can generate ultrasound waves on plaques at different positions on its periphery.
  • the piezoelectric effect layer of the ultrasonic transducer includes a plurality of polymer parts and a plurality of piezoelectric ceramic parts, and the polymer parts and piezoelectric ceramic parts are distributed at intervals in the circumferential direction of the annular body.
  • the design method can reduce the lateral coupling of piezoelectric ceramics in the piezoelectric effect layer, increase the electromechanical conversion efficiency of the piezoelectric effect layer in the radial direction of the annular body, and help reduce the energy loss caused by axial vibration , increase the ultrasonic energy in the radial direction, and at the same time, the polymer part can reduce the overall acoustic resistance of the annular body, so that more ultrasonic energy can be transmitted to the contrast agent in the balloon and act on the calcified plaque, which can Under the joint action of the cavitation bubbles generated by the ultrasonic cavitation effect, the calcified plaque can be crushed, which can better achieve the impact fracture effect of the calcified plaque in the blood vessel, break the stress ring on the calcified plate, and facilitate the development of balloon angioplasty and surgery.
  • stent implantation and it is beneficial to reduce the dependence on the special coating (such as the air microbubble coating in the prior art) on the outer surface of the balloon, and it is even unnecessary to
  • the ultrasonic transducer can transmit ultrasonic energy to the calcified plaque through vibration in the radial direction, so as to cause cracks in the plaque and destroy the internal stress ring.
  • the flexibility of the blood vessels at the plaque is increased to facilitate the expansion of the stent;
  • cavitation bubbles will be generated in the surrounding developer, and the cavitation bubbles will Under the action, it expands at a high speed and finally ruptures, thereby driving the surrounding liquid to form a micro-jet.
  • the micro-jet can crush the surface of the plaque a second time, generate a large number of micro-cracks, and release the local stress of the plaque; the third aspect, ultrasonic transduction
  • the ring-shaped body of the device is located inside the balloon, which can prevent the harmful substances in the ring-shaped body (such as lead in piezoelectric ceramics and other toxic substances) from harming the human body.
  • the first conductive lead wire and the second conductive lead wire can be connected to an external ultrasonic power supply for power supply.
  • the second conductive lead wire outputs a high-frequency voltage signal between the first ring electrode layer and the second ring electrode layer, so that the piezoelectric effect layer between the first ring electrode layer 51 and the second ring electrode layer 53 52 generates mechanical vibrations in the radial direction, thereby generating ultrasonic waves, wherein, in an embodiment of the present invention, the first conductive lead and/or the second conductive lead are arranged along the balloon catheter and located at the surface of the balloon catheter.
  • the annular body 50 is further provided with a first connecting terminal 54 electrically connected to the first annular electrode layer 51, and the first connecting terminal 54 is disposed close to The position of a polymer part 52b extends along the axial direction of the balloon catheter 20, and the first conductive lead is electrically connected to the first ring-shaped 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 arranged at a position close to a polymer part 52b and along the The radial direction of the balloon catheter 20 extends, and the second conductive lead wire is electrically connected to the second ring-shaped electrode 53 through the second connection terminal 55.
  • the second connection terminal 55 can be covered on the ring body 50 The position of the polymer portion on the annular end face of the .
  • the impact on the piezoelectric ceramic can be reduced.
  • the number, size and distribution of polymer parts will affect the performance of the ultrasonic transducer.
  • the proportion of piezoelectric ceramics in the entire piezoelectric effect layer is different, and the overall acoustic impedance and energy density of the piezoelectric effect layer are also different. , it can be understood that the greater the proportion of piezoelectric ceramics, the greater the acoustic impedance and energy density.
  • the area occupied by the plurality of piezoelectric ceramic parts is 40% to 90% of the total area of the annular end surface, for example, It is 60%, 80% etc.;
  • the polymer portion 52b and the piezoelectric ceramic portion 52a are columns with sides perpendicular to the bottom surface, so that the volume of a plurality of piezoelectric ceramic portions is 40% of the total volume of the piezoelectric effect layer ⁇ 90%, which can take into account the overall acoustic impedance and energy density of the piezoelectric effect layer, allowing more ultrasonic energy to act on calcified plaques.
  • the intravascular calcified plaque impact breaking device of the present invention may also include a developing part 40 disposed inside the balloon 30, for example, the developing part 40 may also be correspondingly ring-shaped and sleeved on the balloon catheter 30,
  • the position of the balloon can be observed through the developing part 40, and it can be positioned in the target treatment area, and then the developer is delivered to the inside of the balloon 30 through the balloon catheter 20, and the balloon can be inflated by the developer, and the balloon after expansion At least a part of it can be in close contact with the heart valve or blood vessel with calcified lesions.
  • the expansion and expansion of the balloon can also be observed through the developing solution.
  • the balloon 30 includes a cylindrical shape after expansion.
  • the middle part of the balloon 30 and the conical end after expansion, wherein the annular body 50 is located in the middle part, and the developing part 40 can be located in the end part.
  • the cylindrical middle part of the balloon 30 and the target treatment area The calcified plaques are closely attached to each other, so that the ultrasonic energy generated by the annular body and the micro jets formed by cavitation bubbles can better act on the calcified plaques.
  • the balloon 30 when the balloon 30 is delivered to the target treatment area in the human blood vessel 10 and is filled with the contrast agent, the outer surface of the balloon 30 is close to the calcified plaque 11 in the blood vessel, and the annular shape of the ultrasonic transducer
  • the main body 50 is connected to the external ultrasonic power supply through the first lead wire and the second conductive lead 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 contrast agent in the balloon 30, thereby A large number of microcracks are produced on the plaque.
  • the ultrasound generated by the annular body 50 will be refracted and reflected when 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 imaging agent, most of the energy is reflected back by the interface, and only a small amount of energy enters the imaging agent and finally acts on the calcified plaque.
  • the present invention adopts the piezoelectric composite material arranged at intervals between piezoelectric ceramics and polymers, on the one hand, it can reduce the energy loss caused by axial vibration; on the other hand, it can reduce the overall acoustic resistance of the piezoelectric effect layer, so that more Energy is passed into the contrast agent and acts on the calcified plaque.
  • the polymer portion 52b does not have piezoelectricity, and can be made of a polymer material that does not have piezoelectricity.
  • the material of the polymer portion 52b in the embodiment of the present invention can include polytetrafluoroethylene At least one of vinyl and epoxy resin;
  • the material of the piezoelectric ceramic part 52a may include at least one of PZT 4, PZT 5, and PZT8, and the materials of the first ring-shaped electrode layer and the second ring-shaped electrode layer include steel, copper, aluminum, etc. at least one of .
  • the piezoelectric effect layer is covered by the first annular electrode layer and the second annular electrode layer.
  • the electrode layer is extruded, the first ring-shaped electrode layer is formed on the inner side of the piezoelectric effect layer by cooling and pressing, and the second ring-shaped electrode layer is formed on the inner side of the piezoelectric effect layer by hot pressing. outside of the layer.
  • both the first ring-shaped electrode layer and the second ring-shaped electrode layer are thin-walled stainless steel rings, wherein the outer steel ring as the second ring-shaped electrode layer is inserted into the outer side of the ring-shaped piezoelectric effect layer by hot pressing , as the first annular electrode layer, the inner steel ring is pressed into the inner side of the annular piezoelectric effect layer by cooling, and both the inner and outer steel rings generate extrusion force on the annular piezoelectric effect layer, thereby increasing the energy of piezoelectric ceramics Density, while the inner and outer steel rings also act as electrodes.
  • the balloon catheter 20 is used to deliver a contrast agent to the inside of the balloon 30.
  • the balloon catheter 20 may include an inner tube and an outer tube, and the outer tube is sleeved on the There is an annular cavity on the outer periphery of the inner tube and between the inner tube and the outer tube for delivering developer solution to the inside of the balloon, the opening of the balloon is sealed on the outer tube, and is located at There is a missing area of the outer tube on the outer periphery of the inner tube in the balloon, so that the annular cavity communicates with the interior of the balloon, and the annular body is sheathed on the inner tube located in the missing area.
  • the balloon catheter 20 may only include an inner tube, the opening position of the balloon 30 is sealed on the inner tube, and there is an inner tube located in the balloon. through holes, so that the inner tube communicates with the inside of the balloon, and the annular body is sheathed on the inner tube inside the balloon.
  • the intravascular calcified plaque impact fracture device of the embodiment of the present invention is an interventional device that uses ultrasonic energy generated by the piezoelectric effect of piezoelectric ceramics to crush calcified plaques in blood vessels and promote balloon expansion and stent implantation.
  • the device can destroy the stress ring of the calcified plaque during the balloon angioplasty, so that the balloon can be expanded smoothly, and the success rate and quality can be improved.
  • the specific size and quantity of the annular body in the intravascular calcified plaque impact breaking device can be determined according to the body part to be treated;
  • the above-mentioned intravascular calcified plaque impact rupture device is used in human coronary arteries, which may include two annular bodies distributed along the axial direction of the balloon catheter.
  • the above-mentioned intravascular calcified plaque impact rupture device is used in peripheral arteries of the human body, which may include three annular bodies distributed along the axial direction of the balloon catheter.

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Abstract

L'invention concerne un dispositif de fracture par impact de plaque calcifiée intravasculaire, comprenant un cathéter à ballonnet (20), un transducteur ultrasonore et un ballonnet (30) disposé sur le cathéter à ballonnet (20), le transducteur ultrasonore comprenant un premier fil conducteur, un second fil conducteur, et des corps annulaires (50) disposés à l'intérieur du ballonnet (30) et emmanchés sur le cathéter à ballonnet (20). Chaque corps annulaire (50) comprend une première couche d'électrode annulaire (51), une couche à effet piézoélectrique (52), et une seconde couche d'électrode annulaire (53) ; la première couche d'électrode annulaire (51) est située sur le côté interne dans la direction radiale, la seconde couche d'électrode annulaire (53) est située sur le côté extérieur dans la direction radiale, la couche à effet piézoélectrique (52) est située entre la première couche d'électrode annulaire (51) et la seconde couche d'électrode annulaire (53), la couche à effet piézoélectrique (52) comprend une pluralité de parties céramiques piézoélectriques (52a) et une pluralité de parties polymères (52b) qui n'ont pas de piézoélectricité, et les parties polymères (52b) et les parties céramiques piézoélectriques (52a) sont réparties à intervalles dans la direction circonférentielle du corps annulaire (50). Selon le dispositif de fracture par impact de plaque calcifiée intravasculaire, l'effet de fracture par impact de plaque calcifiée intravasculaire peut être bien réalisé, un anneau de contrainte sur une plaque calcifiée est cassé, et une angioplastie par ballonnet et une implantation d'endoprothèse peuvent être réalisées de manière pratique.
PCT/CN2022/112782 2021-10-28 2022-08-16 Dispositif de fracture par impact de plaque calcifiée intravasculaire WO2023071427A1 (fr)

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CN202111279537.2 2021-10-28
CN202111279537.2A CN114027926A (zh) 2021-10-28 2021-10-28 血管内钙化斑块冲击断裂装置

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Publication number Priority date Publication date Assignee Title
CN114027926A (zh) * 2021-10-28 2022-02-11 嘉兴嘉创智医疗设备有限公司 血管内钙化斑块冲击断裂装置
CN114642477B (zh) * 2022-02-25 2022-10-25 广东博迈医疗科技股份有限公司 血管钙化斑块切割设备
CN116942246A (zh) * 2022-04-13 2023-10-27 深圳高性能医疗器械国家研究院有限公司 用于血管成形术的爆裂波发生方法及爆裂波发生系统
CN115154858A (zh) * 2022-07-26 2022-10-11 深圳高性能医疗器械国家研究院有限公司 爆裂波球囊导管

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