WO2020192146A1 - Ensemble cathéter à ballonnet ultrasonore, système de cathéter et procédé d'utilisation - Google Patents

Ensemble cathéter à ballonnet ultrasonore, système de cathéter et procédé d'utilisation Download PDF

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Publication number
WO2020192146A1
WO2020192146A1 PCT/CN2019/118641 CN2019118641W WO2020192146A1 WO 2020192146 A1 WO2020192146 A1 WO 2020192146A1 CN 2019118641 W CN2019118641 W CN 2019118641W WO 2020192146 A1 WO2020192146 A1 WO 2020192146A1
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WO
WIPO (PCT)
Prior art keywords
ultrasonic
balloon
catheter
catheter assembly
generating element
Prior art date
Application number
PCT/CN2019/118641
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English (en)
Chinese (zh)
Inventor
王卫
Original Assignee
苏州思维医疗科技有限公司
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Publication of WO2020192146A1 publication Critical patent/WO2020192146A1/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
    • 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
    • A61B17/22012—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 in direct contact with, or very close to, the obstruction or concrement
    • A61B17/2202—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 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
    • 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
    • A61B17/22012—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 in direct contact with, or very close to, the obstruction or concrement
    • A61B2017/22025—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 in direct contact with, or very close to, the obstruction or concrement applying a shock wave
    • 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
    • A61B2017/22051—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 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22062—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 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation to be filled with liquid

Definitions

  • the invention relates to an ultrasonic balloon catheter assembly, a catheter system and a use method, in particular to an ultrasonic balloon catheter assembly, a catheter system and a use method for removing calcified substances in blood vessels.
  • Vascular calcification refers to calcium deposits in the walls of arteries and veins, that is, calcified spots on the inner walls of arteries and veins, which seriously threaten the health of patients.
  • a catheter with a balloon is usually inserted into a blood vessel through a small operation, and the balloon is expanded when the balloon reaches the calcium deposit, and the balloon is arranged in the balloon.
  • the electrodes work to release high-voltage pulses to form shock waves, which propagate through the fluid and hit the balloon wall and calcified areas to use the repeated pulses to destroy calcium deposits.
  • the US Shockwave Medical Company provides a variety of implementation solutions for the principle of using shock waves to remove calcium deposits.
  • US patent publication numbers such as US8728091B2, US8888788 B2, US8956371 B2, US8956374 B2, US9011462, etc.
  • This kind of shock wave removes calcified plaques in human blood vessels. It needs to generate higher high-pressure pulses in the human body, and through the generated pulses to promote the formation of bubbles in the liquid filled in the balloon, so that the bubbles act on the balloon wall when they burst. , And then act on the calcified plaque.
  • the thickness of the blood vessels at different positions on the same blood vessel in the human body is not the same, and if the shock wave generated by the pulse is too large, it will cause a certain degree of damage to the blood vessel. Therefore, the above-mentioned technology of using pulse to eliminate calcified plaque in the human body does not It has not been used clinically, and at present, how to safely and effectively remove calcified plaques in blood vessels is still a major technical problem.
  • the first object of the present invention is to provide an ultrasound balloon catheter assembly that can safely and effectively remove calcified plaques in blood vessels.
  • an ultrasonic balloon catheter assembly comprising a catheter and an inflatable balloon arranged on the catheter, the catheter passing through the balloon in the axial direction
  • the cavity is used to pass fluid into the inner cavity of the balloon, and the circumference of the balloon is sealed with the catheter.
  • the catheter assembly also includes an ultrasonic generating element capable of emitting ultrasonic waves. The element is arranged on the catheter and located in the inner cavity of the balloon.
  • the catheter assembly further includes a connecting wire connected to the ultrasonic generating element, and the other end of the connecting wire passes out to the outside of the balloon.
  • the ultrasonic generating elements are arranged in multiple groups at intervals along the length extension direction of the catheter.
  • the ultrasonic generating element is fixedly arranged on the catheter through a carrier ring.
  • the carrier ring is fixedly sleeved on the catheter, and the carrier ring is provided with a supporting platform, and the ultrasonic generating element is fixedly provided on the supporting platform.
  • the carrier ring is a platinum ring or a 316 stainless steel ring.
  • the carrier ring is a ceramic ring plated with a gold layer on the surface.
  • the material of the ceramic ring is aluminum trioxide or aluminum zirconate titanate.
  • the ultrasonic generating elements are arranged in multiple groups at intervals along the length of the catheter, the ultrasonic generating elements are ultrasonic chip elements that can emit ultrasonic waves, and each of the ultrasonic chip elements passes through A carrier ring is fixedly arranged on the catheter, the catheter assembly further includes a connecting wire connected to the ultrasonic generating element, and the other end of the connecting wire penetrates out of the balloon.
  • the carrier ring is fixedly sleeved on the catheter, and the carrier ring is provided with a supporting platform, and the ultrasonic generating element is fixedly provided on the supporting platform.
  • the carrier ring is a platinum ring.
  • the second object of the present invention is to provide an ultrasonic balloon catheter system.
  • an ultrasonic balloon catheter system including the above-mentioned ultrasonic balloon catheter assembly, and also including an ultrasonic control generator for controlling the working state of the ultrasonic generating element, and A power source, and the ultrasonic generating element is connected to the ultrasonic control generator through a connecting wire that passes out of the balloon.
  • the third object of the present invention is to provide a method of using the above-mentioned ultrasonic balloon catheter assembly.
  • the technical solution adopted by the present invention is: a method of using an ultrasonic balloon catheter assembly, using the above-mentioned ultrasonic balloon catheter assembly, and the method of use includes:
  • the working frequency of the ultrasonic generating element is 20KHz-2MHz.
  • the working voltage of the ultrasonic generating element is 350-500V.
  • the ultrasound balloon catheter assembly of the present invention in which the catheter attached with the balloon is provided with an ultrasound generating element capable of emitting ultrasound, which is used to remove In the case of intravascular calcification plaques, you only need to inject fluid to make the balloon inflate and activate the ultrasonic generating element, which can make it emit ultrasonic waves directly through the fluid and the balloon to directly act on the vascular calcification plaques, thereby removing vascular calcification plaques Its purpose is to have good transmittance, to remove calcified spots more directly, and the ultrasonic waves generated during the working process will not cause harm to the human body.
  • Figure 1 is a three-dimensional schematic diagram of the ultrasound balloon catheter assembly of the present invention
  • Figure 2 is a schematic front view of the ultrasound balloon catheter assembly of the present invention
  • Fig. 3 is a schematic sectional view of the structure along the A-A direction in Fig. 2;
  • Fig. 4 is an enlarged schematic diagram of the structure of part B in Fig. 3;
  • Figure 5 is a schematic cross-sectional view of the structure along the line C-C in Figure 4;
  • Figure 6 is a schematic structural diagram of the ultrasound balloon catheter system of the present invention.
  • an ultrasonic balloon catheter assembly includes a catheter 1 and an inflatable balloon 2 arranged on the catheter 1.
  • the catheter 1 passes through the inner cavity of the balloon 2 in the axial direction and is used for Fluid is introduced into the inner cavity of the balloon 2, the circumference of the balloon 2 and the catheter 1 are sealed, and the balloon 2 is inflated after being filled with fluid.
  • the tube section of the catheter 1 located in the inner cavity of the balloon 2 is densely provided with micropores, so that when fluid is passed into the catheter 1, the fluid will enter the balloon 2 through the aforementioned micropores. The cavity, so that the balloon 2 is filled with fluid and then expanded.
  • the catheter assembly also includes an ultrasonic generating element 3 capable of emitting ultrasonic waves.
  • the ultrasonic generating element 3 is arranged on the catheter 1 and located in the inner cavity of the balloon 2.
  • the ultrasonic generating elements 3 may be one set, or multiple sets may be provided at intervals along the longitudinal extension direction of the catheter 1.
  • the catheter assembly also includes a connecting wire 5 connected to the ultrasonic generating element 3, and the other end of the connecting wire 5 penetrates to the outside of the balloon 2 for connecting with an ultrasonic control generator (not shown in the figure).
  • an ultrasonic control generator (not shown in the figure).
  • the ultrasonic generating element 3 may be an ultrasonic chip element capable of emitting ultrasonic waves.
  • the ultrasonic generating element 3 is fixedly arranged on the catheter 1 through the carrier ring 4.
  • the carrier ring 4 is fixedly sleeved on the catheter 1, and there is a supporting platform on it.
  • the ultrasonic generating element 3 is fixedly arranged on the supporting platform.
  • the carrier ring 4 includes a main body ring part that cooperates with the catheter 1 and has a U-shaped cross-section, and a straight section 42 extending from opposite ends of the main body ring part, and an opening 41 is formed between the two straight sections 42 And the two straight sections 42 together form the aforementioned supporting platform, and the ultrasonic generating element 3 is fixedly installed on the two straight sections 42 and is fixedly carried by the carrier ring 4.
  • the carrier ring 4 can be a platinum ring, or a 316 stainless steel ring, or a ceramic ring with a gold layer on the surface, wherein the material of the ceramic ring can be aluminum trioxide or aluminum zirconate titanate.
  • the ultrasonic control generator 6 works and controls the ultrasonic generating element 3 to emit ultrasonic waves, so that the ultrasonic waves directly act on the calcified plaques through the fluid and the balloon, so that the calcified plaques are stripped of blood vessels and fragmented and then discharged from the body with the blood circulation.
  • the ultrasonic frequency emitted by the ultrasonic generating element 3 is controlled by the ultrasonic control generator 6 at 20KHz ⁇ 2MHz, and the working voltage of the ultrasonic generating element 3 is 350 ⁇ 500V.
  • the ultrasonic waves at work are within a safe range for the human body. It will cause damage to the human body and has good safety.
  • the catheter 1 attached with the balloon 2 is provided with an ultrasound generating element 3 capable of emitting ultrasound.
  • an ultrasound generating element 3 capable of emitting ultrasound.
  • the ultrasonic generating element 3 is activated to enable it to emit ultrasonic waves and directly penetrate the fluid to directly act on the vascular calcified plaques, thereby achieving the purpose of removing the vascular calcified plaques.
  • the permeability is good, the removal of calcified spots is more direct, and the safety is better.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Vascular Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Mechanical Engineering (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Surgical Instruments (AREA)
  • Ultra Sonic Daignosis Equipment (AREA)

Abstract

L'invention concerne un ensemble cathéter à ballonnet ultrasonore, comprenant un cathéter (1) et un ballonnet (2) gonflable disposé sur le cathéter (1) ; le cathéter (1) traverse axialement une cavité interne du ballonnet (2) et est utilisé pour introduire un liquide dans la cavité interne du ballonnet (2), la partie périphérique du ballonnet (2) et le cathéter (1) comportent un joint d'étanchéité entre eux ; et ledit ensemble cathéter comprend en outre un élément de génération d'ultrasons (3) capable d'émettre des ultrasons, et l'élément de génération d'ultrasons (3) est disposé sur le cathéter (1) et est situé dans la cavité interne du ballonnet (2). Lorsque l'ensemble cathéter à ballonnet ultrasonore est utilisé pour éliminer une plaque calcifiée intravasculaire, il suffit d'introduire un liquide pour remplir le ballonnet (2), puis d'activer l'élément de génération d'ultrasons (3), permettant à l'élément de génération d'ultrasons d'émettre des ultrasons qui peuvent agir directement sur la plaque calcifiée intravasculaire à travers le liquide et le ballonnet (2), permettant ainsi d'atteindre l'objectif d'élimination de la plaque calcifiée intravasculaire. Ledit procédé parvient à un bon facteur de transmission, à une élimination plus directe de plaque calcifiée, et à une bonne sécurité.
PCT/CN2019/118641 2019-03-22 2019-11-15 Ensemble cathéter à ballonnet ultrasonore, système de cathéter et procédé d'utilisation WO2020192146A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201910220546.0A CN109953799A (zh) 2019-03-22 2019-03-22 一种超声球囊导管组件、导管系统及使用方法
CN201910220546.0 2019-03-22

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WO2020192146A1 true WO2020192146A1 (fr) 2020-10-01

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Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111135425B (zh) * 2020-03-06 2021-09-10 广东博迈医疗科技股份有限公司 一种医用微导管

Citations (8)

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US6296619B1 (en) * 1998-12-30 2001-10-02 Pharmasonics, Inc. Therapeutic ultrasonic catheter for delivering a uniform energy dose
US6461383B1 (en) * 1999-12-30 2002-10-08 Advanced Cardiovascular Systems, Inc. Ultrasonic catheter vascular stent system and method
CN105188830A (zh) * 2012-12-28 2015-12-23 巴德血管外围设备公司 通过机械振动球囊的药物传递
CN105769255A (zh) * 2014-12-25 2016-07-20 乐普（北京）医疗器械股份有限公司 一种单晶多声束换能器消融装置
CN106725838A (zh) * 2016-02-11 2017-05-31 上海魅丽纬叶医疗科技有限公司 兼具球囊扩张和射频消融功能的导管及其消融方法
CN107249487A (zh) * 2015-02-20 2017-10-13 心血管系统股份有限公司 用于破坏生物导管的钙化壁以及在其中的钙化病变的方法与系统
CN107348990A (zh) * 2017-08-25 2017-11-17 江西理工大学 超声除栓系统
CN108371745A (zh) * 2018-03-16 2018-08-07 上海心至医疗科技有限公司 一种带振动的药物洗脱球囊导管系统

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US6398792B1 (en) * 1999-06-21 2002-06-04 O'connor Lawrence Angioplasty catheter with transducer using balloon for focusing of ultrasonic energy and method for use
US6652547B2 (en) * 1999-10-05 2003-11-25 Omnisonics Medical Technologies, Inc. Apparatus and method of removing occlusions using ultrasonic medical device operating in a transverse mode
CN105744902A (zh) * 2013-11-18 2016-07-06 皇家飞利浦有限公司 引导式血栓消散导管
CN109394307A (zh) * 2018-11-19 2019-03-01 储新 一种血管内钙化斑或钙化环超声波研磨装置
CN209996422U (zh) * 2019-03-22 2020-01-31 苏州思维医疗科技有限公司 一种超声球囊导管组件及导管系统

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6296619B1 (en) * 1998-12-30 2001-10-02 Pharmasonics, Inc. Therapeutic ultrasonic catheter for delivering a uniform energy dose
US6461383B1 (en) * 1999-12-30 2002-10-08 Advanced Cardiovascular Systems, Inc. Ultrasonic catheter vascular stent system and method
CN105188830A (zh) * 2012-12-28 2015-12-23 巴德血管外围设备公司 通过机械振动球囊的药物传递
CN105769255A (zh) * 2014-12-25 2016-07-20 乐普（北京）医疗器械股份有限公司 一种单晶多声束换能器消融装置
CN107249487A (zh) * 2015-02-20 2017-10-13 心血管系统股份有限公司 用于破坏生物导管的钙化壁以及在其中的钙化病变的方法与系统
CN106725838A (zh) * 2016-02-11 2017-05-31 上海魅丽纬叶医疗科技有限公司 兼具球囊扩张和射频消融功能的导管及其消融方法
CN107348990A (zh) * 2017-08-25 2017-11-17 江西理工大学 超声除栓系统
CN108371745A (zh) * 2018-03-16 2018-08-07 上海心至医疗科技有限公司 一种带振动的药物洗脱球囊导管系统

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