+

WO2023197367A1 - Procédé de génération d'onde par salves pour angioplastie et système de génération d'onde par salves - Google Patents

Procédé de génération d'onde par salves pour angioplastie et système de génération d'onde par salves Download PDF

Info

Publication number
WO2023197367A1
WO2023197367A1 PCT/CN2022/088753 CN2022088753W WO2023197367A1 WO 2023197367 A1 WO2023197367 A1 WO 2023197367A1 CN 2022088753 W CN2022088753 W CN 2022088753W WO 2023197367 A1 WO2023197367 A1 WO 2023197367A1
Authority
WO
WIPO (PCT)
Prior art keywords
burst wave
transducer
module
burst
wave generation
Prior art date
Application number
PCT/CN2022/088753
Other languages
English (en)
Chinese (zh)
Inventor
肖杨
Original Assignee
深圳高性能医疗器械国家研究院有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 深圳高性能医疗器械国家研究院有限公司 filed Critical 深圳高性能医疗器械国家研究院有限公司
Publication of WO2023197367A1 publication Critical patent/WO2023197367A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A61B17/22022—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement using electric discharge
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22082—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance
    • A61B2017/22091—Explosive

Definitions

  • the present application relates to the technical field of medical devices, and in particular to a burst wave generation method and burst wave generation system for angioplasty.
  • Vascular stenosis is caused by arterial stenosis, which is mainly manifested by the accumulation of lipids and complex carbohydrates in the arteries, bleeding, thrombus, fibrous tissue proliferation, and calcium precipitation, thereby forming atherosclerotic lipid-containing necrosis lesions and blood vessel walls.
  • the hardening of the arteries can block the arterial lumen and hinder blood circulation in severe cases, leading to ischemia or necrosis of blood supplying tissues and organs.
  • calcification occurs in blood vessels, the blood vessel wall becomes irregularly narrowed and occluded, the hardness of the blood vessel increases, and the compliance decreases, making treatment difficult, especially for patients with calcified lesions and calcified nodules.
  • the commonly used interventional treatments for calcified lesions include: one is simple balloon dilatation angioplasty, which expands the lumen through balloon expansion; although the lumen is expanded, it cannot improve vascular compliance, and the incidence of dissection is high.
  • the incidence of postoperative restenosis is high;
  • the second is intravascular shock wave calcification fragmentation, which places a fluid-filled balloon in the calcified area and applies a voltage electric field between the electrodes in the balloon, using the hydroelectric effect to cause rapid expansion of the balloon.
  • the shock wave generated by the hydroelectric effect is difficult to accurately control its conduction area, the direction of the impact force, and its uniformity.
  • the range of action is also small, and the impact pressure acting on the balloon is high (usually up to 50 atmospheres), which can easily cause damage to the balloon, resulting in the risk of high-voltage electric leakage.
  • This application provides a burst wave generation method and burst wave generation system for angioplasty, which are used to solve the problem of poor therapeutic effect and danger during interventional treatment of calcified lesions.
  • This application proposes a burst wave generation method for angioplasty, which includes the following steps:
  • the transducer is located at the distal end of the catheter assembly, and the transducer is transported to a preset position within the blood vessel through the catheter assembly;
  • the burst wave generator Start the burst wave generator, and generate a burst wave at the preset position through the transducer; wherein the signal amplitude range of the burst wave is 20V-500V, the frequency range is 100kHz-10MHz, and the peak pressure is less than 8MPa.
  • the duty cycle range of the burst wave is 0.1%-10%
  • the pulse duration of the burst wave ranges from 10 ⁇ s to 500 ⁇ s;
  • the repetition frequency range of the burst wave is 20Hz-1000Hz.
  • the burst wave generation method further includes the steps:
  • the burst wave generator is started, and the burst wave is generated at the preset position by the transducer, and the burst wave is conducted to the preset position of the blood vessel through the sound-conducting liquid; wherein, the transducer
  • the central frequency range of the energizer is 100kHz-10MHz, and the action area range of the burst wave is 5mm2-150mm2.
  • This application also provides a burst wave generation system for angioplasty, including:
  • a catheter assembly including a catheter body and a balloon, the balloon being connected to the distal end of the catheter body;
  • a burst wave generator is located at the proximal end of the catheter body and is electrically connected to the transducer through a wire connection wire.
  • the burst wave generator is used to drive the transducer to generate a burst wave; wherein,
  • the signal amplitude range of the burst wave is 20V-500V, the frequency range is 100kHz-10MHz, and the peak pressure is less than 8MPa.
  • the catheter assembly further includes a radioactive marking ring, the radioactive marking ring is sleeved on the catheter body, and the radioactive marking ring is located within the balloon.
  • the catheter assembly further includes a liquid-adding syringe
  • the proximal end of the catheter body further includes a liquid-filling interface
  • the liquid-adding syringe is detachably connected to the liquid-filling interface
  • the balloon is connected to the liquid injection interface, and the liquid adding syringe is used to inject sound-conducting liquid into the balloon.
  • the burst wave generator includes a pulse waveform generation module, a connector module and a transducer matching module.
  • the transducer matching module is signal-connected to the pulse waveform generation module and the transducer matching module respectively.
  • a connector module has a high-voltage pulse signal terminal and is connected to the transducer through the high-voltage pulse signal terminal.
  • the burst wave generator further includes a power amplification module, which is respectively connected to the pulse wave generation module and the transducer matching module;
  • the power amplification module includes a gain control module and field effect transistor, and used to amplify the signal sent by the pulse wave generating module;
  • the burst wave generator further includes an operation control module, the operation control module is signal-connected to the pulse waveform generation module and the connector module respectively, and is used to control the startup or shutdown of the pulse waveform generation module.
  • the duty cycle range of the burst wave is 0.1%-10%
  • the pulse duration of the burst wave ranges from 10 ⁇ s to 500 ⁇ s;
  • the repetition frequency range of the burst wave is 20Hz-1000Hz.
  • the number of the transducers is multiple, and the multiple transducers are arranged at intervals along the conduit body, and the burst wave generators are respectively connected with signals to multiple transducers. energy device.
  • the burst wave is generated by starting the transducer through the set burst generator, which can accurately control the burst wave, and the burst wave can be transmitted to the calcified area through the balloon. It is highly efficient and will not damage the soft tissue and balloon around the calcified area, making it highly safe to use.
  • Figure 1 is a schematic flow chart of a burst wave generation method in an embodiment of the present application
  • Figure 2 is a partial flow diagram of a burst wave generation method in an embodiment of the present application
  • Figure 3 is a schematic structural diagram of the burst wave generation system in the embodiment of the present application.
  • Figure 4 is a schematic diagram of the principle of the burst wave generation system in the embodiment of the present application.
  • Figure 5 is a single waveform diagram of the burst wave generated by the burst wave generation system in the embodiment of the present application;
  • Figure 6 is a pulse signal waveform diagram of a burst wave repeatedly emitted by the burst wave generation system in the embodiment of the present application;
  • Catheter assembly 110. Catheter body; 111. Liquid injection interface; 112. Guide wire interface; 113. Connection interface; 120. Balloon; 130. Radioactive marking ring; 140. Liquid adding syringe; 150. Guide wire;
  • Burst wave generator 210. Pulse waveform generation module; 220. Connector module; 230. Transducer matching module; 240. Power amplification module; 250. Operation control module;
  • embodiments of the present application provide a burst wave generation method for angioplasty, which is used to dissolve calcified plaques in blood vessels and improve blood vessel compliance, which includes the following steps:
  • Step S100 Provide the catheter assembly 100 and the transducer 300.
  • the transducer 300 is located at the distal end of the catheter assembly 100, and the transducer 300 is delivered to a preset position in the blood vessel through the catheter assembly 100;
  • Step S200 Provide a burst wave generator 200, and connect the burst wave generator 200 to the transducer 300 through wires;
  • Step S300 Start the burst wave generator 200 and generate a burst wave at a preset position through the transducer 300.
  • the signal amplitude range of the burst wave is 20V-500V
  • the frequency range is 100kHz-10MHz
  • the peak pressure is less than 8MPa.
  • the burst wave is generated by starting the transducer 300 through the set burst generator.
  • the burst wave can be accurately controlled, and the burst wave can be conducted to the calcified area through the balloon 120, with high conduction efficiency. High, while not damaging the soft tissue and balloon 120 around the calcification area, it is highly safe to use.
  • a high-voltage pulse electrical signal is applied to both ends of the electrodes of the transducer 300 through the burst wave generator 200, so that the transducer 300 repeatedly generates burst waves.
  • the burst wave generation method of this embodiment utilizes the mechanical effect of the generated burst wave to generate a controllable, repetitive, and uniform mechanical force that directly acts on the calcified plaque to crack and break it without damaging the surrounding tissue.
  • the soft tissue and balloon 120 in the catheter assembly 100 effectively improve the compliance of blood vessels without causing thermal damage.
  • the action area can be controlled by the shape and structure of the transducer 300, the emission energy can be adjusted to control the size of the action force, and the emission frequency can be adjusted to control the size of the calcified fragments.
  • the structure of the transducer 300 includes but is not limited to single array element, multiple array element, circular tube shape, flat plate shape, area array, and ring array.
  • the duty cycle range of the burst wave is 0.1%-10%; the pulse duration range of the burst wave is 10 ⁇ s-500 ⁇ s; and the repetition frequency range of the burst wave is 20Hz-1000Hz.
  • the burst wave of this embodiment compared with the existing shock wave, the burst wave has a longer pulse delay time, an order of magnitude lower energy than the shock wave, and a higher repetition frequency.
  • the transducer 300 By setting the transducer 300 to output the burst wave, it is possible By adjusting the emission energy to control the size of the force, and adjusting the emission frequency to control the size of the calcified fragments, the effect is good.
  • the catheter body 110 includes a guide wire interface 112 and a connection interface 113.
  • the guide wire interface 112 is used to penetrate the guide wire 150 and guide the movement of the catheter body 110 so that the catheter assembly 100 moves to a preset position.
  • the connection interface 113 is used to pass through the connection wire 310 and electrically connect the burst wave generator 200 and the transducer 300 .
  • the burst wave generator 200 includes a plurality of signal ports, and is electrically connected to a plurality of transducers 300 through the plurality of signal ports, so that the plurality of transducers 300 emit high-voltage pulse signals to generate bursts. Wave.
  • the preset position is preferably a calcified lesion area within the blood vessel.
  • the burst wave generator 200 is started and the transducer 300 generates burst waves to crush the calcified tissue in the calcified lesion area. Thereby achieving the effect of dredging blood vessels.
  • step S300 also includes the steps:
  • Step S301 Provide a liquid-adding syringe 140 connected to the conduit assembly 100, and inject the sound-conducting liquid into the conduit assembly 100 so that it is located at a preset position;
  • Step S302 Start the burst wave generator 200, and generate a burst wave at a preset position through the transducer 300.
  • the burst wave is conducted to the preset position of the blood vessel through the sound-guiding liquid; wherein, the center frequency range of the transducer 300 is 100 kHz. -10MHz, the action area of the burst wave is 5mm2-150mm2.
  • the catheter assembly 100 further includes a liquid filling interface 111, and is connected to an external liquid filling syringe 140 through the liquid filling interface 111, and the catheter body 110 is connected to the balloon 120 through the liquid filling interface 111.
  • the catheter body 110 The distal end has a liquid filling port connected to the liquid injection interface 111.
  • the liquid filling port is located inside the balloon 120.
  • the balloon 120 is sealingly connected to the catheter body 110 and is enclosed with the catheter body 110 to form a liquid injection cavity.
  • the liquid filling syringe 140 Inject the sound-conducting liquid through the connection interface 113 and fill it outside the transducer 300.
  • the sound-conducting liquid is sealed in the liquid injection cavity through the balloon 120 to prevent it from leaking to the blood vessels. middle.
  • the burst wave generator 200 drives the transducer 300 to generate a burst wave
  • the burst wave can be transmitted through the sound-conducting liquid, thereby ensuring the impact strength of the burst wave.
  • the present application also provides a burst wave generation system 10 for angioplasty, which includes a catheter assembly 100, a burst wave generator 200 and a transducer 300.
  • the catheter assembly 100 is used for The transducer 300 is guided to move to a preset position, and the burst wave generator 200 is used to drive the transducer 300 to generate a burst wave; specifically, the catheter assembly 100 includes a catheter body 110 and a balloon 120, and the balloon 120 is connected to the catheter body 110. the distal end; the transducer 300 is located in the balloon 120; the burst wave generator 200 is located at the proximal end of the catheter body 110, and is electrically connected to the transducer 300 through the connecting wire 310.
  • the burst wave generator 200 is A burst wave is generated by driving the transducer 300; the signal amplitude range of the burst wave is 20V-500V, the frequency range is 100kHz-10MHz, and the peak pressure is less than 8MPa.
  • the burst wave is generated by starting the transducer 300 with the burst generator.
  • the burst wave can be accurately controlled, and the burst wave can be transmitted to the calcified area through the balloon 120. It is highly efficient, will not damage the soft tissue and balloon 120 around the calcification area, and is highly safe to use.
  • the burst wave generated by the burst wave generation system 10 of this embodiment has a longer pulse delay time, an order of magnitude lower energy than the shock wave, and a higher repetition frequency.
  • the device 300 outputs a burst wave, and can control the size of the force by adjusting the emission energy, and control the size of the calcification fragments by adjusting the emission frequency, and the use effect is good.
  • the conduit body 110 can be made of insulating materials such as polyimide, polyetheretherketone, PEBA, PET, FEP, PTFE, etc.
  • the connecting wire 310 can be made of conductive materials such as gold, silver, platinum, copper, etc. There is no unique limitation here.
  • the number of transducers 300 is multiple, and the multiple transducers 300 are spaced apart along the conduit body 110 , and the burst wave generator 200 is connected to the multiple transducers 300 via signals respectively.
  • the number of transducers 300 may be two or more, the center frequency range of the transducers 300 may be 100kHz-10MHz, and the action area of the burst wave may be 5mm2-150mm2.
  • the transducer 300 can be a piezoelectric transducer. In other embodiments, the transducer 300 can also use, for example, mechanical energy, acoustic energy, magnetic energy, optical energy and thermal energy to generate burst waves. This is not the case here. Make the only limitation.
  • the catheter assembly 100 also includes a guide wire 150; the catheter body 110 includes a guide wire interface 112 and a connection interface 113.
  • the guide wire interface 112 is used to penetrate the guide wire 150 and guide the movement of the catheter body 110 to The catheter assembly 100 is moved to a preset position, and the connection interface 113 is used to pass through the connection wire 310 and electrically connect the burst wave generator 200 and the transducer 300 .
  • the burst wave generator 200 includes a plurality of signal ports, and is electrically connected to a plurality of transducers 300 through the plurality of signal ports, so that the plurality of transducers 300 emit high-voltage pulse signals to generate bursts. Wave.
  • the catheter assembly 100 further includes a radioactive marking ring 130 .
  • the radioactive marking ring 130 is sleeved on the catheter body 110 , and the radioactive marking ring 130 is located in the balloon 120 .
  • the position of the transducer 300 in the blood vessel can be determined by developing the radioactive marking ring 130; specifically, the radioactive marking ring 130 can be used to detect under X-ray Develop, including but not limited to, made of platinum materials.
  • the catheter assembly 100 further includes a liquid filling syringe 140, and the proximal end of the catheter body 110 further includes a liquid filling interface 111.
  • the liquid filling syringe 140 is detachably connected to the liquid filling interface 111; the balloon 120 is connected through the catheter body 110.
  • the liquid adding syringe 140 is used to inject the sound-conducting liquid into the balloon 120.
  • the balloon 120 is sealingly connected to the distal end of the catheter body 110 to form a liquid injection cavity, and the transducer 300 and at least part of the catheter body 110 are located in the liquid injection cavity.
  • the balloon 120 is filled with the catheter
  • the acoustic liquid is then expanded to adhere to the inner wall of the blood vessel and/or the calcified tissue.
  • the burst wave generated by the transducer 300 can be transmitted to the balloon 120 through the acoustic liquid with almost no loss and further reach the calcified area.
  • the sound-conducting liquid may be physiological saline or a physiological saline/contrast agent mixture
  • the balloon 120 may be made of sound-conducting materials, including but not limited to non-compliant sound-conducting materials such as PET, such as polyethylene.
  • non-compliant sound-conducting materials such as PET, such as polyethylene.
  • Semi-compliant sound-conducting materials such as ethylene, PBAX, nylon, and PEBA, and compliant sound-conducting materials such as polyurethane and silicone.
  • the burst wave generator 200 includes a pulse waveform generation module 210, a connector module 220 and a transducer matching module 230.
  • the transducer matching module 230 is signal-connected to the pulse waveform generation module 210 and the connection module 230, respectively.
  • the connector module 220 has a high-voltage pulse signal terminal and is connected to the transducer 300 through the high-voltage pulse signal terminal.
  • the pulse waveform generation module 210 supports multi-channel waveform transmission, corresponding to multiple transducers 300, and the timing and waveform parameters of each channel can be independently controlled.
  • the excitation sequence control is completed by a programmable logic device (FPGA).
  • the basic parameters of the pulses including frequency, number, duty cycle, repetition frequency, etc., can be programmed and controlled;
  • the connector module 220 is provided with a high-voltage pulse signal terminal, and passes the high-voltage
  • the pulse signal end is connected to the connection interface 113 of the conduit body 110 to provide the transducer 300 to emit pulse signals to generate burst waves.
  • the transducer matching module 230 includes an inductor, a capacitor, and a resistor, matches the output resistance to 50 ohms, and is connected to the connector module 220 for signals.
  • the burst wave generator 200 also includes a power amplification module 240, which is connected to the pulse wave generation module and the transducer matching module 230 respectively; the power amplification module 240 includes a gain control module and a field effect transistor, and is used for amplification The signal sent by the pulse wave generation module.
  • the power amplification module 240 amplifies the amplitude of the signal generated by the receiving front-end pulse waveform generation module 210, and then sends it to the power metal-oxide semiconductor field effect transistor for power amplification.
  • the two signals are connected to the programmable logic device and Under its control, the amplified waveform is output to the impedance matching circuit and conducted to the transducer 300 to generate a burst wave.
  • the burst wave generator 200 further includes an operation control module 250.
  • the operation control module 250 is connected with signals to the pulse waveform generation module 210 and the connector module 220 respectively, and is used to control the startup or shutdown of the pulse waveform generation module 210.
  • the operation control module 250 can be an operating handle or a foot pedal, and is connected to a programmable logic device with signals.
  • the key instructions can be compiled, and the pulse waveform generation module 210 can be controlled accordingly through the control signal to implement the corresponding function. .
  • the duty cycle of the burst wave ranges from 0.1% to 10%; the pulse duration of the burst wave ranges from 10 ⁇ s to 500 ⁇ s; and the repetition frequency range of the burst wave ranges from 20 Hz to 1000 Hz.
  • the burst wave of this embodiment compared with the existing shock wave, the burst wave has a longer pulse delay time, an order of magnitude lower energy than the shock wave, and a higher repetition frequency.
  • the transducer 300 By setting the transducer 300 to output the burst wave, it is possible By adjusting the emission energy to control the size of the force, and adjusting the emission frequency to control the size of the calcified fragments, the effect is good.
  • the transducer matching module 230 includes a matching layer, an electrode layer, a piezoelectric material layer, a common electrode layer, a backing layer and a connecting wire 310.
  • Multiple transducers 300 are connected in parallel, and their common electrode layers Commonly connected to the connecting wire 310, each electrode layer independently leads out the wire, and is connected to the high-voltage pulse signal end of the connector module 220 of the burst wave generator 200 at the proximal end of the catheter body 110, and the burst wave generator 200 provides a transmission signal.
  • a burst wave is generated, as shown in Figure 3.
  • the transducer 300 can be in the shape of a circular tube and is set on the outside of the catheter body 110.
  • the inner diameter of the circular tube transducer 300 ranges from 0.5mm to - 3mm, the outer diameter range is 1mm-5mm, and the tube length range is 1mm-10mm; when the transducer 300 is flat, the length range of the transducer 300 is 0.5mm-10mm, and the width range is 0.5mm-5mm.
  • the transducer 300 is a piezoelectric energy conversion device that converts the received high-voltage pulse electrical signal into a burst wave signal in the ultrasonic frequency range. It can adopt a circular tube shape or a back-to-back planar structure, and can be regarded as an approximate
  • the point source is a multi-layered structure, and the action area and direction of the burst wave can be controlled by setting the shape, structure, and size of the transducer 300 .
  • the emission energy can be set to control the size of the force
  • the emission frequency can be set to control the size of the calcified fragments to meet the needs of treating different degrees of vascular calcification lesions.
  • the piezoelectric material layer can realize mutual conversion between electrical signals and acoustic signals according to its unique piezoelectric effect, and is the core component of the transducer 300. After receiving the electrical signal, the piezoelectric material layer will move in the thickness direction. The piezoelectric material vibrates to generate a burst wave signal, and its operating frequency is related to the size of the material. The thinner the piezoelectric material layer, the higher the operating frequency.
  • the piezoelectric material layer can be prepared using materials including, but not limited to, piezoelectric single crystals, polycrystalline piezoelectric ceramics, polymer piezoelectric materials, and polymer-piezoelectric ceramic composite materials.
  • the common electrode layer and the electrode layer can be made of conductive materials such as gold, silver, platinum, copper, etc.
  • a plurality of connection wires 310 connecting the common electrode layer and the electrode layer of the transducer 300 are placed in multiple inner cavities of the catheter body 110, connected with the connection interface 113 of the catheter body 110, and with the connector module of the burst wave generator 200 220 is connected, thereby providing a high-voltage pulse signal to the transducer 300 through the burst wave generator 200 to generate a burst wave.
  • the backing layer absorbs the energy radiated internally by the piezoelectric material layer due to vibration and prevents interference caused by energy reflection.
  • the backing layer can be prepared using epoxy resin, tungsten powder, alumina powder and additives that enhance attenuation.
  • the matching layer can be prepared using epoxy resin and dense powder such as alumina, glass powder, etc., so as to acoustically match the acoustic impedance of the transducer 300 with the acoustic impedance of the biological tissue and enhance the burst wave energy propagated into the tissue.
  • connection should be understood in a broad sense.
  • it can be a fixed connection or a detachable connection. Or integrated connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium.
  • connection should be understood in specific situations.
  • the first feature "on” or “below” the second feature may be that the first and second features are in direct contact, or the first and second features are in intermediate contact. Indirect media contact.
  • the terms “above”, “above” and “above” the first feature is above the second feature may mean that the first feature is directly above or diagonally above the second feature, or simply means that the first feature is higher in level than the second feature.
  • "Below”, “below” and “beneath” the first feature to the second feature may mean that the first feature is directly below or diagonally below the second feature, or simply means that the first feature has a smaller horizontal height than the second feature.
  • references to the terms “one embodiment,” “some embodiments,” “an example,” “specific examples,” or “some examples” or the like means that specific features are described in connection with the embodiment or example. , structures, materials or features are included in at least one embodiment or example of the embodiments of this application. In this specification, the schematic expressions of the above terms are not necessarily directed to the same embodiment or example. Furthermore, the specific features, structures, materials or characteristics described may be combined in any suitable manner in any one or more embodiments or examples. Furthermore, those skilled in the art may combine and combine different embodiments or examples and features of different embodiments or examples described in this specification unless they are inconsistent with each other.

Landscapes

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

Abstract

L'invention concerne un procédé de génération d'onde par salves pour angioplastie et un système de génération d'onde par salves (10). Le procédé de génération d'onde par salves comprend les étapes suivantes consistant à : fournir un ensemble cathéter (100) et un transducteur (300) disposé à l'extrémité distale de l'ensemble cathéter (100), et poser le transducteur (300) au niveau d'une position prédéfinie dans un vaisseau sanguin au moyen de l'ensemble cathéter (100) (S100) ; fournir un générateur d'onde par salves (200), et connecter le générateur d'onde par salves (200) au transducteur (300) au moyen d'un fil de connexion (310) (S200) ; et démarrer le générateur d'onde par salves (200) pour générer une onde par salves au niveau de la position prédéfinie au moyen du transducteur (300) (S300). Selon le procédé de génération d'onde par salves, le transducteur (300) est démarré au moyen du générateur d'onde par salves fourni (200) pour générer une onde par salves, de telle sorte que l'onde par salves peut être commandée avec précision. L'onde par salves peut être conduite vers une région vasculaire calcifiée au moyen d'un ballonnet (120) avec une efficacité de conduction élevée, et ne provoquera pas de lésion du tissu mou et du ballonnet (120) autour de la région calcifiée, possédant ainsi une sécurité élevée.
PCT/CN2022/088753 2022-04-13 2022-04-24 Procédé de génération d'onde par salves pour angioplastie et système de génération d'onde par salves WO2023197367A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202210385096.2 2022-04-13
CN202210385096.2A CN116942246A (zh) 2022-04-13 2022-04-13 用于血管成形术的爆裂波发生方法及爆裂波发生系统

Publications (1)

Publication Number Publication Date
WO2023197367A1 true WO2023197367A1 (fr) 2023-10-19

Family

ID=88328726

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2022/088753 WO2023197367A1 (fr) 2022-04-13 2022-04-24 Procédé de génération d'onde par salves pour angioplastie et système de génération d'onde par salves

Country Status (2)

Country Link
CN (1) CN116942246A (fr)
WO (1) WO2023197367A1 (fr)

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0582766A1 (fr) * 1992-08-13 1994-02-16 Ministero Dell' Universita' E Della Ricerca Scientifica E Tecnologica Système et transducteur pour recanalisation par ultrason
CN109674508A (zh) * 2017-10-19 2019-04-26 美敦力瓦斯科尔勒公司 用于在脉管内产生脉冲波的导管
US20190282249A1 (en) * 2018-03-14 2019-09-19 Boston Scientific Scimed, Inc. Balloon-based intravascular ultrasound system for treatment of vascular lesions
CN110623703A (zh) * 2019-09-10 2019-12-31 丁·奥利弗 一种用于心血管碎石的超声波球囊及球囊导管系统
US20200129195A1 (en) * 2018-10-24 2020-04-30 Boston Scientific Scimed, Inc. Photoacoustic pressure wave generation for intravascular calcification disruption
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
US20220054155A1 (en) * 2020-08-24 2022-02-24 National Tsing Hua University Balloon catheter system assisted by ultrasound and microbubbles and method for vasodilation

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0582766A1 (fr) * 1992-08-13 1994-02-16 Ministero Dell' Universita' E Della Ricerca Scientifica E Tecnologica Système et transducteur pour recanalisation par ultrason
CN109674508A (zh) * 2017-10-19 2019-04-26 美敦力瓦斯科尔勒公司 用于在脉管内产生脉冲波的导管
US20190282249A1 (en) * 2018-03-14 2019-09-19 Boston Scientific Scimed, Inc. Balloon-based intravascular ultrasound system for treatment of vascular lesions
US20200129195A1 (en) * 2018-10-24 2020-04-30 Boston Scientific Scimed, Inc. Photoacoustic pressure wave generation for intravascular calcification disruption
CN110623703A (zh) * 2019-09-10 2019-12-31 丁·奥利弗 一种用于心血管碎石的超声波球囊及球囊导管系统
US20220054155A1 (en) * 2020-08-24 2022-02-24 National Tsing Hua University Balloon catheter system assisted by ultrasound and microbubbles and method for vasodilation
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

Also Published As

Publication number Publication date
CN116942246A (zh) 2023-10-27

Similar Documents

Publication Publication Date Title
JP7232757B2 (ja) バルーンカテーテルを通して機械的波動を送達するための装置
US7135029B2 (en) Ultrasonic surgical instrument for intracorporeal sonodynamic therapy
JP4873816B2 (ja) ガイドワイヤトラッキング機構を備えた先端部可撓性カテーテル
EP2629681B1 (fr) Émetteur-récepteur d'ultrasons
US6755821B1 (en) System and method for stimulation and/or enhancement of myocardial angiogenesis
CN114027926B (zh) 血管内钙化斑块冲击断裂装置
US20210007759A1 (en) Ultrasound transducer and array for intravascular thrombolysis
AU2002316433A1 (en) An ultrasonic surgical instrument for intracorporeal sonodynamic therapy
JP2004503324A (ja) 膨張性環状レンズによるエネルギー付与装置
CN110623703A (zh) 一种用于心血管碎石的超声波球囊及球囊导管系统
CN115778485A (zh) 冲击波发生装置、冲击波发生系统和方法
WO2022023968A1 (fr) Dispositif médical à émission d'ondes ultrasonores
CN113729855B (zh) 介入式组合超声溶栓装置
CN114916992A (zh) 一种集成脉冲聚焦超声的压力波球囊导管及其使用方法
WO2023197367A1 (fr) Procédé de génération d'onde par salves pour angioplastie et système de génération d'onde par salves
JPH10248854A (ja) 超音波治療装置
US20070232986A1 (en) Low-profile implantable ultrasound array and method for enhancing drug delivery to tissue
WO2024021159A1 (fr) Cathéter à ballonnet à onde en rafale
CN219021398U (zh) 一种集成脉冲聚焦超声的压力波球囊导管
CN211325372U (zh) 一种用于心血管碎石的超声波球囊及球囊导管系统
WO2000033913A2 (fr) Systeme et procede de stimulation et/ou de renforcement de l'angiogenese myocardique
CN114948079A (zh) 一种超声换能装置及其治疗系统
WO2024000633A1 (fr) Système de génération d'onde de choc avant pour le traitement de maladies occlusives
CN219538433U (zh) 载药球囊及具有其的医疗设备
RU225238U1 (ru) Устройство для ультразвуковой облитерации подкожных вен нижних конечностей

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 22937011

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

点击 这是indexloc提供的php浏览器服务，不要输入任何密码和下载