CN116942246A - Burst wave generating method and burst wave generating system for angioplasty - Google Patents

Burst wave generating method and burst wave generating system for angioplasty Download PDF

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Publication number
CN116942246A
CN116942246A CN202210385096.2A CN202210385096A CN116942246A CN 116942246 A CN116942246 A CN 116942246A CN 202210385096 A CN202210385096 A CN 202210385096A CN 116942246 A CN116942246 A CN 116942246A
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China
Prior art keywords
burst
transducer
wave
generator
module
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CN202210385096.2A
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Chinese (zh)
Inventor
肖杨
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Shenzhen National Research Institute of High Performance Medical Devices Co Ltd
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Shenzhen National Research Institute of High Performance Medical Devices Co Ltd
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Priority to CN202210385096.2A priority Critical patent/CN116942246A/en
Priority to PCT/CN2022/088753 priority patent/WO2023197367A1/en
Publication of CN116942246A publication Critical patent/CN116942246A/en
Pending legal-status Critical Current

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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
    • 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
    • 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
    • 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
    • A61B17/22022—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 using electric discharge
    • 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
    • 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
    • A61B2017/22082—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 after introduction of a substance
    • A61B2017/22091—Explosive

Abstract

The application relates to the technical field of medical instruments, in particular to a burst wave generation method and a burst wave generation system for angioplasty. The burst wave generation method comprises the following steps: providing a catheter assembly and a transducer, the transducer being disposed at a distal end of the catheter assembly, the transducer being delivered through the catheter assembly to a preset location within a blood vessel; providing a burst generator, connecting the burst generator with the transducer through a connecting wire; and starting the burst wave generator and generating burst waves at the preset position through the transducer. In the burst wave generation method of the embodiment, the transducer is started by the arranged burst generator to generate burst waves, the burst waves can be precisely controlled, the burst waves can be conducted to the calcified areas of the blood vessels through the sacculus, the conduction efficiency is high, meanwhile, soft tissues and the sacculus around the calcified areas can not be damaged, and the use safety is high.

Description

Burst wave generating method and burst wave generating system for angioplasty
Technical Field
The application relates to the technical field of medical instruments, in particular to a burst wave generation method and a burst wave generation system for angioplasty.
Background
Vascular stenosis is caused by arterial vascular stenosis and is mainly characterized by accumulation of lipid and complex carbohydrate substances in arteries, bleeding, thrombus, fibrous tissue hyperplasia and calcareous precipitation, so that atheromatous necrosis focus and hardening of vascular walls are formed, and arterial lumen is blocked and blood circulation is blocked in severe cases, so that ischemic or necrotic tissue and organ of blood supply is caused. When calcification occurs in the blood vessel, irregular stenosis and occlusion of the blood vessel wall, increased hardness of the blood vessel, reduced compliance, and difficult treatment, especially for patients with calcified lesions and calcified nodules.
Currently, the usual interventional methods for calcified lesions are: one is a simple balloon dilation angioplasty, which expands a lumen by balloon inflation; although the lumen is enlarged, the vascular compliance cannot be improved, the occurrence rate of interlayer is high, and the occurrence rate of restenosis after operation is high; secondly, in intravascular shock wave calcification fragmentation, placing a balloon filled with liquid in a calcified area, applying a voltage electric field between electrodes in the balloon, and conducting shock waves to the calcified area by utilizing the rapid expansion of the balloon caused by the electrohydraulic effect; but the shock wave generated by utilizing the hydro-electric effect is difficult to accurately control the conduction area, the direction and uniformity of the impact force, the action range is smaller, the impact pressure acting on the balloon is higher (generally up to 50 atmospheres), the balloon is easy to damage, and the danger of high-voltage electric leakage is generated.
How to realize calcified tissue disruption and ensure operation safety is an important topic to be solved in the industry at present.
Disclosure of Invention
The application provides a burst wave generation method and a burst wave generation system for angioplasty, which are used for solving the problems of poor treatment effect and danger in calcified lesion interventional therapy.
The application provides a burst wave generation method for angioplasty, which comprises the following steps:
providing a catheter assembly and a transducer, the transducer being disposed at a distal end of the catheter assembly, the transducer being delivered through the catheter assembly to a preset location within a blood vessel;
providing a burst generator, connecting the burst generator to the transducer through a wire connection lead;
starting the burst wave generator and generating burst waves at the preset position through the transducer; wherein the signal amplitude range of the bursting wave is 20V-500V, the frequency range is 100kHz-10MHz, and the peak pressure is less than 8MPa.
According to one embodiment of the application, the burst wave has a duty cycle in the range of 0.1% -10%;
and/or the burst has a pulse duration in the range of 10 mus to 500 mus;
and/or the burst wave has a repetition frequency in the range of 20Hz to 1000Hz.
According to one embodiment of the application, the method of generating a pop wave further comprises the steps of:
providing a liquid feeding injector connected to the catheter assembly and injecting sound guiding liquid into the catheter assembly so as to be positioned at the preset position;
starting the burst wave generator, and generating burst waves at the preset position through the transducer, wherein the burst waves are conducted to the preset position of the blood vessel through the sound guiding liquid; wherein the central frequency range of the transducer is 100kHz-10MHz, and the action area range of the bursting wave is 5mm 2 -150mm 2 。
The present application also provides a pop-wave generating system for angioplasty, comprising:
a catheter assembly comprising a catheter body and a balloon, the balloon being connected to a distal end of the catheter body;
the transducer is arranged in the balloon; and
the burst wave generator is arranged at the proximal end of the catheter body and is electrically connected with the transducer through a lead wire connection lead wire, and the burst wave generator is used for driving the transducer to generate burst waves; wherein the signal amplitude range of the bursting wave is 20V-500V, the frequency range is 100kHz-10MHz, and the peak pressure is less than 8MPa.
According to one embodiment of the application, the catheter assembly further comprises a radiolabel ring, the radiolabel ring is sleeved on the catheter body, and the radiolabel ring is located within the balloon.
According to one embodiment of the application, the catheter assembly further comprises a liquid feeding syringe, the proximal end of the catheter body further comprising a liquid injection port, the liquid feeding syringe being detachably connected to the liquid injection port; the saccule is communicated with the liquid injection interface through the catheter body, and the liquid adding injector is used for injecting sound guiding liquid into the saccule.
According to one embodiment of the application, the burst wave generator comprises a pulse waveform generation module, a connector module and a transducer matching module, wherein the transducer matching module is respectively connected with the pulse waveform generation module and the connector module in a signal way, and the connector module is provided with a high-voltage pulse signal end and is connected with the transducer through the high-voltage pulse signal end.
According to one embodiment of the application, the pop wave generator further comprises a power amplification module, which is respectively connected to the pulse wave generation module and the transducer matching module; the power amplification module comprises a gain control module and a field effect transistor and is used for amplifying signals sent by the pulse wave generation module;
and/or the burst wave generator further comprises an operation control module which is respectively connected with the pulse waveform generation module and the connector module in a signal manner and is used for controlling the starting or the closing of the pulse waveform generation module.
According to one embodiment of the application, the burst wave has a duty cycle in the range of 0.1% -10%;
and/or the burst has a pulse duration in the range of 10 mus to 500 mus;
and/or the burst wave has a repetition frequency in the range of 20Hz to 1000Hz.
According to one embodiment of the application, the number of the transducers is a plurality, the transducers are arranged at intervals along the catheter body, and the burst generators are respectively connected with the transducers in a signal mode.
The embodiment of the application has the following beneficial effects:
in the burst wave generation method and the generation system, the transducer is started by the arranged burst generator to generate burst waves, so that the burst waves can be precisely controlled, the burst waves can be conducted to the calcified region through the balloon, the conduction efficiency is high, meanwhile, soft tissues and the balloon around the calcified region can not be damaged, and the use safety is high.
Drawings
In order to more clearly illustrate the embodiments of the application or the technical solutions in the prior art, the drawings that are required in the embodiments or the description of the prior art will be briefly described, it being obvious that the drawings in the following description are only some embodiments of the application, and that other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.
Wherein:
FIG. 1 is a schematic flow chart of a method of generating a pop wave in an embodiment of the application;
FIG. 2 is a schematic flow diagram of a portion of a method of generating a pop in an embodiment of the application;
FIG. 3 is a schematic diagram of a burst wave generation system in accordance with an embodiment of the present application;
FIG. 4 is a schematic diagram of a pop wave generation system in accordance with an embodiment of the present application;
FIG. 5 is a single waveform diagram of a pop wave generated by a pop wave generation system in an embodiment of the application;
FIG. 6 is a waveform diagram of a pulse signal of a burst wave repeatedly emitted by a burst wave generating system in accordance with an embodiment of the present application;
reference numerals:
10. a pop wave generation system;
100. a catheter assembly; 110. a catheter body; 111. a liquid injection interface; 112. a guidewire interface; 113. a connection interface; 120. a balloon; 130. a radiolabeled ring; 140. a liquid adding injector; 150. a guide wire;
200. a burst wave generator; 210. a pulse waveform generation module; 220. a connector module; 230. a transducer matching module; 240. a power amplification module; 250. an operation control module;
300. a transducer; 310. and connecting the connecting wires.
Detailed Description
For the purpose of making the objects, technical solutions and advantages of the present application more apparent, the technical solutions of the present application will be clearly and completely described below with reference to the accompanying drawings, and it is apparent that the described embodiments are some embodiments of the present application, not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application.
Referring to fig. 1 to 6, an embodiment of the present application provides a burst wave generation method for angioplasty, which is applied to crack calcified plaque in blood vessels to improve vascular compliance, comprising the steps of:
step S100, providing a catheter assembly 100 and a transducer 300, wherein the transducer 300 is arranged at the distal end of the catheter assembly 100, and the transducer 300 is conveyed to a preset position in a blood vessel through the catheter assembly 100;
step S200, providing a burst wave generator 200, and connecting the burst wave generator 200 with the transducer 300 through a wire;
step S300, the burst generator 200 is started, and a burst wave is generated at a preset position by the transducer 300. Wherein the signal amplitude range of the bursting wave is 20V-500V, the frequency range is 100kHz-10MHz, and the peak pressure is less than 8MPa.
In the method for generating a pop wave according to the present embodiment, the transducer 300 is activated by the set pop generator to generate the pop wave, so that the pop wave can be precisely controlled, and the pop wave can be conducted to the calcified region through the balloon 120, so that the conduction efficiency is high, and meanwhile, soft tissues around the calcified region and the balloon 120 are not damaged, so that the use safety is high. When the burst generator 200 is used, a high voltage pulse electrical signal is applied across the electrodes of the transducer 300 by the burst generator 200 to cause the transducer 300 to repeatedly generate a burst wave.
It should be noted that, by using the mechanical effect of the generated burst wave, the burst wave generating method of the present embodiment generates a controllable, repeated and uniform mechanical force to directly act on the calcified plaque, so as to make it crack and break, without damaging surrounding soft tissues and the balloon 120 in the catheter assembly 100, thereby effectively improving the compliance of the blood vessel and not generating thermal injury. And the area of action can be controlled by the shape and structure of the transducer 300, the energy emitted is adjusted to control the magnitude of the applied force, and the frequency emitted is adjusted to control the size of calcified fragments. Specifically, the structure of the transducer 300 includes, but is not limited to, a single array element, a multiple array element, a circular tube, a flat plate, an area array, and a ring array.
Further, the burst has a duty cycle in the range of 0.1% -10%; the pulse duration of the burst wave ranges from 10 mus to 500 mus; the repetition frequency of the burst wave ranges from 20Hz to 1000Hz.
Compared with the existing shock wave, the burst wave of the embodiment has longer pulse delay time, energy which is lower than that of the shock wave by an order of magnitude, and higher repetition frequency, and the energy converter 300 is arranged to output the burst wave, so that the acting force can be controlled by adjusting the emission energy, and the calcified fragments can be controlled by adjusting the emission frequency, so that the use effect is good.
Specifically, 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 move the catheter assembly 100 to a predetermined position, and the connection interface 113 is used to pass through the connection wire 310 and electrically connect the burst generator 200 with the transducer 300. In one embodiment, the burst generator 200 includes a plurality of signal ports, and is electrically connected to the plurality of transducers 300 through the plurality of signal ports, so that the plurality of transducers 300 emit high-voltage pulse signals to generate burst waves.
In the pop generating system 10 of the present application, the predetermined location is preferably a calcified lesion area in a blood vessel, and the pop generator 200 is activated to generate a pop wave to break up calcified tissue of the calcified lesion area, thereby dredging the blood vessel.
Specifically, referring to fig. 2 and 3, step S300 further includes the steps of:
step S301, providing the liquid feeding syringe 140 connected to the catheter assembly 100, and injecting the sound guiding liquid into the catheter assembly 100 so as to be located at a preset position;
step S302, starting the burst wave generator 200, generating burst waves at preset positions through the transducer 300, and conducting the burst waves to the preset positions of the blood vessel through the sound guiding liquid; wherein the transducer 300 has a center frequency in the range of 100kHz-10MHz and a burst action area in the range of 5mm 2 -150mm 2 。
In this embodiment, the catheter assembly 100 further includes a liquid injection port 111, and is connected to an external liquid injection syringe 140 through the liquid injection port 111, and the catheter body 110 is communicated with the balloon 120 through the liquid injection port 111, the distal end of the catheter body 110 has a liquid injection port communicated with the liquid injection port 111, the liquid injection port is located inside the balloon 120, the balloon 120 is connected to the catheter body 110 in a sealing manner, and encloses the catheter body 110 to form a liquid injection cavity, the liquid injection syringe 140 injects the sound guiding liquid through the connection port 113 and fills the sound guiding liquid outside the transducer 300, and it should be noted that the sound guiding liquid is sealed in the liquid injection cavity through the balloon 120 to avoid leaking into the blood vessel. When the pop generator 200 drives the transducer 300 to generate a pop, the pop may be conducted through the sound guiding liquid, thereby securing the impact strength of the pop.
Referring to fig. 3-5, the present application also provides a burst generating system 10 for angioplasty, comprising a catheter assembly 100, a burst generator 200 and a transducer 300, the catheter assembly 100 being configured to guide the transducer 300 to a predetermined position, the burst generator 200 being configured to drive the transducer 300 to generate a burst wave; specifically, catheter assembly 100 includes a catheter body 110 and a balloon 120, balloon 120 being connected to a distal end of catheter body 110; transducer 300 is disposed within balloon 120; the burst generator 200 is disposed at the proximal end of the catheter body 110 and electrically connected to the transducer 300 via the connection wire 310, and the burst generator 200 is used for driving the transducer 300 to generate burst waves; wherein the signal amplitude range of the bursting wave is 20V-500V, the frequency range is 100kHz-10MHz, and the peak pressure is less than 8MPa.
In the pop generating system 10 of the present embodiment, the pop can be precisely controlled by activating the transducer 300 through the set pop generator, and the pop can be conducted to the calcified region through the balloon 120, so that the conduction efficiency is high, and meanwhile, soft tissues around the calcified region and the balloon 120 are not damaged, so that the use safety is high.
Compared with the existing shock wave, the burst wave generated by the burst wave generating system 10 of the embodiment has longer pulse delay time, energy which is lower than that of the shock wave by an order of magnitude, and higher repetition frequency, and the energy converter 300 is arranged to output the burst wave, so that the acting force can be controlled by adjusting the emission energy, and calcified fragments can be controlled by adjusting the emission frequency, so that the use effect is good. Specifically, the catheter body 110 may be made of an insulating material such as polyimide, polyetheretherketone, PEBA, PET, FEP, PTFE, etc., and the connection lead 310 may be made of a conductive material such as gold, silver, platinum, copper, etc., which is not limited thereto.
Further, the number of the transducers 300 is plural, and the plural transducers 300 are spaced along the catheter body 110, and the burst generator 200 is respectively signal-connected to the plural transducers 300.
Specifically, the number of the transducers 300 may be two or more, the center frequency of the transducers 300 may be in the range of 100kHz-10MHz, and the action area of the burst wave may be 5mm 2 -150mm 2 。
In one embodiment, the transducer 300 may be a piezoelectric transducer, and in other embodiments, the transducer 300 may generate a pop wave using, for example, mechanical energy, acoustic energy, magnetic energy, optical energy, and thermal energy, without limitation.
In particular, catheter assembly 100 further 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 configured to penetrate the guide wire 150 and guide movement of the catheter body 110 to move the catheter assembly 100 to a predetermined position, and the connection interface 113 is configured to penetrate the connection lead 310 and electrically connect the burst generator 200 to the transducer 300. In one embodiment, the burst generator 200 includes a plurality of signal ports, and is electrically connected to the plurality of transducers 300 through the plurality of signal ports, so that the plurality of transducers 300 emit high-voltage pulse signals to generate burst waves.
Further, referring to fig. 2, the catheter assembly 100 further includes a radiolabel ring 130, the radiolabel ring 130 is sleeved on the catheter body 110, and the radiolabel ring 130 is located in the balloon 120.
Thus configured, after placement of the burst generation system 10 within a blood vessel, the position of the transducer 300 within the blood vessel can be determined by visualizing the radiolabeled ring 130; in particular, the radiolabeled ring 130 may be used for visualization under X-rays, including but not limited to being made of platinum material.
In one embodiment, catheter assembly 100 further comprises a priming syringe 140, and the proximal end of catheter body 110 further comprises a priming port 111, with priming syringe 140 being removably connected to priming port 111; balloon 120 is in communication with fluid injection port 111 via catheter body 110, and fluid injection syringe 140 is used to inject acoustically-conductive fluid into balloon 120.
In this embodiment, the balloon 120 is sealingly connected to the distal end of the catheter body 110 and forms a fluid-filled cavity, and the transducer 300 and at least a portion of the catheter body 110 are both positioned within the fluid-filled cavity so that when the balloon 120 is inflated after being filled with an acoustically conductive fluid, it conforms to the inner wall of the blood vessel and/or calcified tissue, and the burst waves generated by the transducer 300 are conducted through the acoustically conductive fluid to the balloon 120 and further to the calcified area with little loss. In particular, the sound guiding fluid may be saline or a saline/contrast mixture, and balloon 120 may be made of sound guiding materials including, but not limited to, non-compliant sound guiding materials such as PET, semi-compliant sound guiding materials such as polyethylene, PBAX, nylon, PEBA, and compliant sound guiding materials such as polyurethane, silicone, and the like.
Specifically, referring to fig. 4, the burst generator 200 includes a pulse waveform generating module 210, a connector module 220, and a transducer matching module 230, the transducer matching module 230 is respectively signal-connected to the pulse waveform generating module 210 and the connector module 220, and 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.
In this embodiment, the pulse waveform generation module 210 supports multi-channel waveform transmission, and the timing and waveform parameters of each channel can be controlled independently corresponding to the plurality of transducers 300. The excitation time sequence control is completed by a programmable logic device (FPGA), and the basic parameters of the pulse comprise frequency, number, duty ratio, repetition frequency and the like which can be programmed and controlled; the connector module 220 is provided with a high voltage pulse signal terminal and is connected with the connection interface 113 of the catheter body 110 through the high voltage pulse signal terminal to provide the transducer 300 to emit a pulse signal to generate a burst wave. Specifically, the transducer matching module 230 includes an inductance, a capacitance, a resistance, and matches the output resistance to 50 ohms and is in signal connection with the connector module 220.
Further, the pop generator 200 further includes a power amplification module 240, and the power amplification module 240 is connected to the pulse wave generation module and the transducer matching module 230, respectively; the power amplifying module 240 includes a gain control module and a field effect transistor, and is used for amplifying the signal emitted by the pulse wave generating module.
In this embodiment, the power amplification module 240 amplifies the amplitude of the signal generated by the front-end pulse waveform generation module 210, and sends the amplified signal to the power mosfet for power amplification, and the signal is connected to and controlled by the programmable logic device, and the amplified waveform is output to the impedance matching circuit and is conducted to the transducer 300 for generating the burst wave.
In one embodiment, the pop generator 200 further includes an operation control module 250, where the operation control module 250 is respectively signal-connected to the pulse waveform generating module 210 and the connector module 220, and is used to control the start or stop of the pulse waveform generating module 210.
Specifically, the operation control module 250 may be an operation handle or a foot pedal, and is connected to the programmable logic device through a signal, and when in use, a key command may be compiled, and the pulse waveform generation module 210 is correspondingly controlled by a control signal to realize a corresponding function.
In a preferred embodiment, the burst wave has a duty cycle in the range of 0.1% -10%; the pulse duration of the burst wave ranges from 10 mus to 500 mus; the repetition frequency of the burst wave ranges from 20Hz to 1000Hz.
Compared with the existing shock wave, the burst wave of the embodiment has longer pulse delay time, energy which is lower than that of the shock wave by an order of magnitude, and higher repetition frequency, and the energy converter 300 is arranged to output the burst wave, so that the acting force can be controlled by adjusting the emission energy, and the calcified fragments can be controlled by adjusting the emission frequency, so that the use effect is good.
Specifically, 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 connection wire 310, among which a plurality of transducers 300 are connected in parallel, the common electrode layers are commonly connected to the connection wire 310, the respective electrode layers are respectively and independently led out of the wire, the proximal end of the catheter body 110 is respectively connected with the high-voltage pulse signal end of the connector module 220 of the burst generator 200, and the burst generator 200 provides a transmitting signal to generate burst waves, and in this embodiment, the transducer 300 may be circular tube-shaped and sleeved outside the catheter body 110, specifically, the circular tube-shaped transducer 300 has an inner diameter ranging from 0.5mm to 3mm, an outer diameter ranging from 1mm to 5mm, and a tube length ranging from 1mm to 10mm, as shown in fig. 3; when the transducer 300 is planar, the transducer 300 has a length in the range of 0.5mm-10mm and a width in the range of 0.5mm-5mm.
It should be noted that, the piezoelectric energy conversion device of the transducer 300 for converting the received high-voltage pulse electric signal into the burst wave signal in the ultrasonic frequency range may adopt a tubular or back-to-back planar structure, may be regarded as an approximate point source when in use, is a multi-layer structure, and may control the action area and direction of the burst wave by setting the shape, structure and size of the transducer 300. By separately routing each transducer 300, the energy emitted can be set to control the amount of force and the frequency emitted can be set to control the size of calcified fragments to meet the need for treatment of vascular calcification lesions of varying degrees.
Further, the piezoelectric material layer, which is a core component of the transducer 300, can realize the mutual conversion of an electrical signal and an acoustic signal according to the specific piezoelectric effect thereof, and vibrate in the thickness direction thereof to generate a burst signal after receiving the electrical signal, and the working frequency thereof is related to the size of the material, and the thinner the piezoelectric material layer, the higher the working frequency thereof. Specifically, the piezoelectric material layer may be prepared from piezoelectric single crystals, polycrystalline piezoelectric ceramics, high-molecular piezoelectric materials and polymer-piezoelectric ceramic composite materials.
The common electrode layer and the electrode layer may be made of a conductive material such as gold, silver, platinum, copper, or the like. A plurality of connection wires 310 connecting the common electrode layer and the electrode layer of the transducer 300 are placed in a plurality of lumens of the catheter body 110, communicate with the connection interface 113 of the catheter body 110, and are connected with the connector module 220 of the burst generator 200, thereby generating burst waves by supplying high voltage pulse signals to the transducer 300 through the burst generator 200.
Further, the backing layer absorbs energy radiated to the inside of the piezoelectric material layer due to vibration, prevents interference caused by energy reflection, and can be specifically prepared from epoxy resin, tungsten powder, alumina powder and an additive for enhancing attenuation.
In particular, the matching layer may be made of epoxy and a dense powder, such as alumina, glass frit, or the like, to acoustically match the acoustic impedance of the transducer 300 to that of biological tissue, enhancing the burst wave energy propagating into the tissue.
In the description of the embodiments of the present application, it should be noted that the terms "center", "longitudinal", "lateral", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, are merely for convenience in describing the embodiments of the present application and simplifying the description, and do not indicate or imply that the apparatus or elements referred to must have a specific orientation, be configured and operated in a specific orientation, and thus should not be construed as limiting the embodiments of the present application. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.
In describing embodiments of the present application, it should be noted that, unless explicitly stated and limited otherwise, the terms "coupled," "coupled," and "connected" should be construed broadly, and may be either a fixed connection, a removable connection, or an integral connection, for example; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium. The specific meaning of the above terms in embodiments of the present application will be understood in detail by those of ordinary skill in the art.
In embodiments of the application, unless expressly specified and limited otherwise, a first feature "up" or "down" on a second feature may be that the first and second features are in direct contact, or that the first and second features are in indirect contact via an intervening medium. Moreover, a first feature being "above," "over" and "on" a second feature may be a first feature being directly above or obliquely above the second feature, or simply indicating that the first feature is level higher than the second feature. The first feature being "under", "below" and "beneath" the second feature may be the first feature being directly under or obliquely below the second feature, or simply indicating that the first feature is less level than the second feature.
In the description of the present specification, a description referring to terms "one embodiment," "some embodiments," "examples," "specific examples," or "some examples," etc., means that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the embodiments of the present application. In this specification, schematic representations of the above terms are not necessarily directed to the same embodiment or example. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples. Furthermore, the different embodiments or examples described in this specification and the features of the different embodiments or examples may be combined and combined by those skilled in the art without contradiction.
Finally, it should be noted that: the above embodiments are only for illustrating the technical solution of the present application, and are not limiting; although the application has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical scheme described in the foregoing embodiments can be modified or some technical features thereof can be replaced by equivalents; such modifications and substitutions do not depart from the spirit and scope of the technical solutions of the embodiments of the present application.

Claims (10)

1. A method of generating a burst wave for use in angioplasty, comprising the steps of:
providing a catheter assembly and a transducer, the transducer being disposed at a distal end of the catheter assembly, the transducer being delivered through the catheter assembly to a preset location within a blood vessel;
providing a burst generator, connecting the burst generator with the transducer through a connecting wire;
starting the burst wave generator and generating burst waves at the preset position through the transducer; wherein the signal amplitude range of the bursting wave is 20V-500V, the frequency range is 100kHz-10MHz, and the peak pressure is less than 8MPa.
2. The method of claim 1, wherein the burst wave has a duty cycle in the range of 0.1% -10%;
and/or the burst has a pulse duration in the range of 10 mus to 500 mus;
and/or the burst wave has a repetition frequency in the range of 20Hz to 1000Hz.
3. The method of generating a burst wave of claim 1, further comprising the steps of:
providing a liquid feeding injector connected to the catheter assembly and injecting sound guiding liquid into the catheter assembly so as to be positioned at the preset position;
starting the burst wave generator, and generating burst waves at the preset position through the transducer, wherein the burst waves are conducted to the preset position of the blood vessel through the sound guiding liquid; wherein the central frequency range of the transducer is 1MHz-10MHz, and the action area range of the bursting wave is 5mm 2 -150mm 2 。
4. A pop-wave generating system for angioplasty, comprising:
a catheter assembly comprising a catheter body and a balloon, the balloon being connected to a distal end of the catheter body;
the transducer is arranged in the balloon; and
the burst wave generator is arranged at the proximal end of the catheter body and is electrically connected with the transducer through a connecting wire, and the burst wave generator is used for driving the transducer to generate burst waves; wherein the signal amplitude range of the bursting wave is 20V-500V, the frequency range is 100kHz-10MHz, and the peak pressure is less than 8MPa.
5. The pop wave generation system of claim 4, wherein the catheter assembly further comprises a radiolabel ring that is positioned over the catheter body and within the balloon.
6. The pop generating system of claim 4, wherein the catheter assembly further comprises a liquid filling syringe, the proximal end of the catheter body further comprising a liquid filling port, the liquid filling syringe being removably connected to the liquid filling port; the saccule is communicated with the liquid injection interface through the catheter body, and the liquid adding injector is used for injecting sound guiding liquid into the saccule.
7. The system of claim 4, wherein the burst generator comprises a pulse waveform generation module, a connector module, and a transducer matching module, the transducer matching module being signally connected to the pulse waveform generation module and the connector module, respectively, the connector module having a high voltage pulse signal end and being connected to the transducer through the high voltage pulse signal end.
8. The pop wave generation system of claim 7, wherein the pop wave generator further comprises a power amplification module connected to the pulse wave generation module and the transducer matching module, respectively; the power amplification module comprises a gain control module and a field effect transistor and is used for amplifying signals sent by the pulse wave generation module;
and/or the burst wave generator further comprises an operation control module which is respectively connected with the pulse waveform generation module and the connector module in a signal manner and is used for controlling the starting or the closing of the pulse waveform generation module.
9. The pop wave generation system of claim 4, wherein the duty cycle of the pop wave ranges from 0.1% to 10%;
and/or the burst has a pulse duration in the range of 10 mus to 500 mus;
and/or the burst wave has a repetition frequency in the range of 20Hz to 1000Hz.
10. The system of any of claims 4-8, wherein the number of transducers is a plurality and a plurality of the transducers are spaced along the catheter body, the burst generator being respectively signally connected to a plurality of the transducers.
CN202210385096.2A 2022-04-13 2022-04-13 Burst wave generating method and burst wave generating system for angioplasty Pending CN116942246A (en)

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PCT/CN2022/088753 WO2023197367A1 (en) 2022-04-13 2022-04-24 Burst wave generation method for angioplasty and burst wave generation system

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EP0582766A1 (en) * 1992-08-13 1994-02-16 Ministero Dell' Universita' E Della Ricerca Scientifica E Tecnologica Ultrasonic recanalization system and transducer therefor
US11071557B2 (en) * 2017-10-19 2021-07-27 Medtronic Vascular, Inc. Catheter for creating pulse wave within vasculature
US11103262B2 (en) * 2018-03-14 2021-08-31 Boston Scientific Scimed, Inc. Balloon-based intravascular ultrasound system for treatment of vascular lesions
EP3870092A1 (en) * 2018-10-24 2021-09-01 Boston Scientific Scimed, Inc. Photoacoustic pressure wave generation for intravascular calcification disruption
CN110623703A (en) * 2019-09-10 2019-12-31 丁·奥利弗 Ultrasonic balloon for cardiovascular lithotripsy and balloon catheter system
EP4201481A1 (en) * 2020-08-24 2023-06-28 Tsing Hua University Ultrasound and microbubble assisted balloon catheter system, and vascular dilation method using same
CN114027926A (en) * 2021-10-28 2022-02-11 嘉兴嘉创智医疗设备有限公司 Intravascular calcified plaque impact fracture device

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