WO2023197367A1

WO2023197367A1 - Burst wave generation method for angioplasty and burst wave generation system

Info

Publication number: WO2023197367A1
Application number: PCT/CN2022/088753
Authority: WO
Inventors: 肖杨
Original assignee: 深圳高性能医疗器械国家研究院有限公司
Priority date: 2022-04-13
Filing date: 2022-04-24
Publication date: 2023-10-19
Also published as: CN116942246A

Abstract

Provided are a burst wave generation method for angioplasty and a burst wave generation system (10). The burst wave generation method comprises the following steps: providing a catheter assembly (100) and a transducer (300) arranged at the distal end of the catheter assembly (100), and delivering the transducer (300) to a preset position in a blood vessel by means of the catheter assembly (100) (S100); providing a burst wave generator (200), and connecting the burst wave generator (200) to the transducer (300) by means of a connecting wire (310) (S200); and starting the burst wave generator (200) to generate a burst wave at the preset position by means of the transducer (300) (S300). According to the burst wave generation method, the transducer (300) is started by means of the provided burst wave generator (200) to generate a burst wave, such that the burst wave can be accurately controlled. The burst wave can be conducted to a calcified vascular region by means of a balloon (120) with high conduction efficiency, and will cause no damage to the soft tissue and the balloon (120) around the calcified region, thus possessing high safety.

Description

Burst wave generation method and burst wave generation system for angioplasty

Technical field

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.

Background technique

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. When 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.

technical problem

Currently, 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. to conduct shock waves to the calcified area; however, 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.

How to break up calcified tissue while ensuring surgical safety is an important issue that needs to be solved urgently in the industry.

Technical solutions

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:

Provide a catheter assembly and a transducer, 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;

Provide a burst wave generator, and connect the burst wave generator to the transducer through a wire connection wire;

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.

According to an embodiment of the present application, the duty cycle range of the burst wave is 0.1%-10%;

and/or the pulse duration of the burst wave ranges from 10 μs to 500 μs;

And/or the repetition frequency range of the burst wave is 20Hz-1000Hz.

According to an embodiment of the present application, the burst wave generation method further includes the steps:

Provide a liquid-adding syringe connected to the conduit assembly, and inject the sound-conducting liquid into the conduit assembly so that it is located at the preset position;

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 transducer located in the balloon; and

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.

According to one embodiment of the present application, 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.

According to one embodiment of the present application, the catheter assembly further includes a liquid-adding syringe, the proximal end of the catheter body further includes a liquid-filling interface, and the liquid-adding syringe is detachably connected to the liquid-filling interface; the balloon The catheter body is connected to the liquid injection interface, and the liquid adding syringe is used to inject sound-conducting liquid into the balloon.

According to an embodiment of the present application, 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.

According to an embodiment of the present application, 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;

And/or 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.

and/or the pulse duration of the burst wave ranges from 10 μs to 500 μs;

And/or the repetition frequency range of the burst wave is 20Hz-1000Hz.

According to an embodiment of the present application, 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.

beneficial effects

Implementing the embodiments of this application has the following beneficial effects:

In the burst wave generation method and generation system of this embodiment, 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.

Description of the drawings

In order to explain the embodiments of the present application or the technical solutions in the prior art more clearly, the drawings needed to be used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings in the following description are only These are some embodiments of the present application. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without exerting creative efforts.

in:

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;

Reference signs:

10. Explosion wave generation system;

100. 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;

200. Burst wave generator; 210. Pulse waveform generation module; 220. Connector module; 230. Transducer matching module; 240. Power amplification module; 250. Operation control module;

300. Transducer; 310. Connecting wires.

Embodiments of the invention

The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only some of the embodiments of the present application, rather than all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by those of ordinary skill in the art without creative efforts fall within the scope of protection of this application.

Referring to Figures 1 to 6, 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. Among them, 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.

In the burst wave generation method of this embodiment, 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. When the burst wave generator 200 is used, 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.

It should be noted that 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. And 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. Specifically, 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.

Further, the duty cycle range of the burst wave is 0.1%-10%; the pulse duration range of the burst wave is 10μs-500μs; and the repetition frequency range of the burst wave is 20Hz-1000Hz.

Using 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. 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.

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 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 . In one embodiment, 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.

In the burst wave generation system 10 of the present application, 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.

Specifically, referring to Figures 2 and 3, 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.

In this embodiment, 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. It should be noted that at this time, 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. When 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.

Referring to Figures 3 to 5, 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.

In the burst wave generation system 10 of this embodiment, 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.

Compared with the existing shock wave, 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. By setting the energy transducer 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. Specifically, the conduit body 110 can be made of insulating materials such as polyimide, polyetheretherketone, PEBA, PET, FEP, PTFE, etc., and the connecting wire 310 can be made of conductive materials such as gold, silver, platinum, copper, etc. There is no unique limitation here.

Furthermore, 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.

Specifically, 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.

In one embodiment, 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.

Specifically, 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 . In one embodiment, 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.

Further, as shown in FIG. 2 , 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 .

According to this arrangement, after the burst wave generating system 10 is placed in the blood vessel, 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.

In one embodiment, 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. In the liquid injection interface 111, the liquid adding syringe 140 is used to inject the sound-conducting liquid into the balloon 120.

In this embodiment, 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. When 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. Specifically, the sound-conducting liquid may be physiological saline or a physiological saline/contrast agent mixture, and 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. Semi-compliant sound-conducting materials such as ethylene, PBAX, nylon, and PEBA, and compliant sound-conducting materials such as polyurethane and silicone.

Specifically, as shown in Figure 4, 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.

In this embodiment, 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. Specifically, 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.

Further, 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.

In this embodiment, 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.

In one embodiment, 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.

Specifically, the operation control module 250 can be an operating handle or a foot pedal, and is connected to a programmable logic device with signals. When used, 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. .

In a preferred embodiment, the duty cycle of the burst wave ranges from 0.1% to 10%; the pulse duration of the burst wave ranges from 10 μs to 500 μs; and the repetition frequency range of the burst wave ranges from 20 Hz to 1000 Hz.

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 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. In this embodiment, the transducer 300 can be in the shape of a circular tube and is set on the outside of the catheter body 110. Specifically, 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.

It should be noted that 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 . By providing separate leads to each transducer 300, the emission energy can be set to control the size of the force, and 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.

Furthermore, 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. Specifically, 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.

Furthermore, the backing layer absorbs the energy radiated internally by the piezoelectric material layer due to vibration and prevents interference caused by energy reflection. Specifically, the backing layer can be prepared using epoxy resin, tungsten powder, alumina powder and additives that enhance attenuation.

Specifically, 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.

In the description of the embodiments of the present application, it should be noted that the terms "center", "longitudinal", "horizontal", "upper", "lower", "front", "back", "left" and "right" The orientations or positional relationships indicated by "vertical", "horizontal", "top", "bottom", "inner", "outer", etc. are based on the orientations or positional relationships shown in the accompanying drawings and are only for the convenience of describing this document. The application embodiments and simplified descriptions do not indicate or imply that the devices or elements referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be construed as limiting the embodiments of the 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 the description of the embodiments of this application, it should be noted that, unless otherwise clearly stated and limited, the terms "connected" and "connected" should be understood in a broad sense. For example, 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. For those of ordinary skill in the art, the specific meanings of the above terms in the embodiments of the present application can be understood in specific situations.

In the embodiments of this application, unless otherwise expressly provided and limited, 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. Furthermore, 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.

In the description of this specification, reference 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.

Finally, it should be noted that the above embodiments are only used to illustrate the technical solution of the present application, but not to limit it; although the present application has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that it can still be Modifications are made to the technical solutions described in the foregoing embodiments, or equivalent substitutions are made to some of the technical features; however, these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions in the embodiments of the present application.

Claims

A burst wave generation method for angioplasty, characterized by including the following steps:

Provide a catheter assembly and a transducer, 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;

Provide a burst wave generator, and connect the burst wave generator to the transducer through a connecting wire;

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 burst wave generation method according to claim 1, characterized in that the duty cycle range of the burst wave is 0.1%-10%;

and/or the pulse duration of the burst wave ranges from 10 μs to 500 μs;

And/or the repetition frequency range of the burst wave is 20Hz-1000Hz.
The burst wave generation method according to claim 1, characterized in that the burst wave generation method further includes the steps:

Provide a liquid-adding syringe connected to the conduit assembly, and inject the sound-conducting liquid into the conduit assembly so that it is located at the preset position;

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 center frequency range of the energizer is 1MHz-10MHz, and the action area range of the burst wave is 5mm2-150mm2.
A burst wave generation system for angioplasty, characterized by including:

a catheter assembly, including a catheter body and a balloon, the balloon being connected to the distal end of the catheter body;

a transducer located in the balloon; and

A burst wave generator is located at the proximal end of the catheter body and is electrically connected to the transducer through a connecting wire. The burst wave generator is used to drive the transducer to generate a burst wave; wherein, the 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 blast wave generation system according to claim 4, wherein 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 on the ball. In the capsule.
The burst wave generation system according to claim 4, wherein the catheter assembly further includes a liquid-adding syringe, the proximal end of the catheter body further includes a liquid-filling interface, and the liquid-adding syringe is detachably connected to the Liquid injection interface; the balloon is connected to the liquid injection interface through the catheter body, and the liquid adding syringe is used to inject sound-conducting liquid into the balloon.
The burst wave generation system according to claim 4, characterized in that the burst wave generator includes a pulse waveform generation module, a connector module and a transducer matching module, and the transducer matching module is respectively connected to the The pulse waveform generating module and the connector module, the 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 generation system according to claim 7, wherein the burst wave generator further includes a power amplification module, and the power amplification module is respectively connected to the pulse wave generation module and the transducer matching module. ;The power amplification module includes a gain control module and a field effect transistor, and is used to amplify the signal sent by the pulse wave generation module;

And/or 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 burst wave generation system according to claim 4, characterized in that the duty cycle range of the burst wave is 0.1%-10%;

and/or the pulse duration of the burst wave ranges from 10 μs to 500 μs;

And/or the repetition frequency range of the burst wave is 20Hz-1000Hz.
The burst wave generation system according to any one of claims 4 to 8, characterized in that the number of the transducers is multiple, and the plurality of transducers are arranged at intervals along the conduit body, and the The burst wave generator is signal-connected to a plurality of the transducers respectively.