WO2024000633A1 - 治疗闭塞性病变的前向爆裂波发生系统 - Google Patents

治疗闭塞性病变的前向爆裂波发生系统 Download PDF

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Publication number
WO2024000633A1
WO2024000633A1 PCT/CN2022/104870 CN2022104870W WO2024000633A1 WO 2024000633 A1 WO2024000633 A1 WO 2024000633A1 CN 2022104870 W CN2022104870 W CN 2022104870W WO 2024000633 A1 WO2024000633 A1 WO 2024000633A1
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Prior art keywords
burst wave
catheter body
transducer
generation system
burst
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PCT/CN2022/104870
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English (en)
French (fr)
Inventor
肖杨
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深圳高性能医疗器械国家研究院有限公司
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Publication of WO2024000633A1 publication Critical patent/WO2024000633A1/zh

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Classifications

    • 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
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1002—Balloon catheters characterised by balloon shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B2017/22005—Effects, e.g. on tissue
    • A61B2017/22007—Cavitation or pseudocavitation, i.e. creation of gas bubbles generating a secondary shock wave when collapsing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A61B2017/22014—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement the ultrasound transducer being outside patient's body; with an ultrasound transmission member; with a wave guide; with a vibrated guide wire
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/109—Balloon catheters with special features or adapted for special applications having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/32—General characteristics of the apparatus with radio-opaque indicia

Definitions

  • the present application relates to the technical field of medical devices, and more specifically, to a forward burst wave generation system for treating occlusive lesions.
  • CTO Arterial chronic total occlusion
  • vascular interventional therapy is the best treatment for CTO patients.
  • the current vascular interventional therapy methods for CTO lesions mainly include: 1 CTO-specific guidewire and catheter passing technology, including antegrade guidewire technology (Ategrade wire entry (AWE), forward sandwich reentry technology (Ategrade dissection/re-entry (ADR), Retrograde wire escalation (RWE), forward wire escalation technology uses guide wires of different hardnesses to pass forward through CTO lesions; forward dissection re-entry true cavity technology refers to surgical operations Artificially causes blunt subintimal tearing, allowing the guidewire to advance from under the intima across the occluded segment and into the true lumen of the distal blood vessel; in reverse guidewire technology, hydrophilic-coated guidewires with a composite axis design are often used to treat occlusions.
  • the forward burst wave generation system of the lesion With the support of the forward burst wave generation system of the lesion, it reaches the distal end of the occlusion via the retrograde collateral circulation, and controls the retrograde guide wire to pass through the fibrous cap at the distal end of the lesion, reach the proximal end of the lesion, meet the antegrade guide wire, and guide the antegrade guide wire through the occlusion segment.
  • the above-mentioned traditional guidewires and catheters can only achieve an opening rate of about 50%.
  • the surgery is complex and requires the operator and patient to be exposed to radiation for a long time.
  • the risk of perioperative complications is high, such as stroke, coronary artery perforation, and dissection.
  • the internal structure erodes the solid surface of the CTO, thereby automatically and selectively ablating plaques.
  • the ultrasonic energy that produces the cavitation effect is relatively large, which will produce significant thermal effects and easily cause thermal damage to normal soft tissues in blood vessels; 6Shock wave fragmentation, A high-voltage electric field is applied between the two electrodes, and the electrode discharge causes the liquid to vaporize and expand rapidly, generating cavitation bubbles or shock waves that act on the CTO lesion area to remove obstructions or make holes.
  • the disadvantages of this solution are: first, it is difficult to accurately control the conduction area, the direction and uniformity of the impact force; second, the impact force attenuates exponentially with distance.
  • the purpose of this application is to overcome the above-mentioned defects of the existing technology and provide a forward burst wave generation system for treating occlusive lesions, which utilizes forward burst waves of high frequency, short duration, and high repetition frequency to generate repetitive mechanical force. It directly acts on the obstruction in the blood vessel to fully break down the obstruction into tiny particles. At the same time, it does not produce thermal effects and does not damage the normal soft tissue in the blood vessel.
  • a forward burst wave generation system for treating occlusive lesions including a catheter body and a forward transducer;
  • the end of the catheter body close to the operator is the proximal end, and the end of the catheter body used to enter the blood vessel is the distal end;
  • the forward transducer is disposed at the distal end of the catheter body, the forward transducer is used to vibrate to generate burst waves, and the burst waves propagate forward along the axial direction of the catheter body;
  • the burst wave includes a plurality of pulse waves, the pulse wave includes a plurality of consecutive simple harmonic vibration cycles, the frequency of the pulse wave is 50 kHz ⁇ 15 MHz, and the duration of the pulse wave is 5 ⁇ s ⁇ 800 ⁇ s, The repetition frequency of the burst wave is 20 Hz ⁇ 5000 Hz.
  • the burst wave of this application can provide repeated forward mechanical force to directly act on the obstruction in the blood vessel without producing thermal effects and causing no thermal damage to the surrounding normal soft tissue.
  • the burst wave transmitted to the obstruction is high frequency (50 kHz ⁇ 15MHz), short duration (5 ⁇ s ⁇ 800 ⁇ s) of ultrasonic waves can directly act on the obstruction, cracking the obstruction into tiny particles (5 ⁇ m ⁇ 20 ⁇ m), thereby eliminating the obstruction, and the fragmented tiny particles can enter the blood circulation due to their smaller particle size, and It is cleared by phagocytes in the liver, spleen and lungs and will not cause secondary obstruction.
  • the burst wave of the present application Since the burst wave of the present application has a short duration, a low duty cycle, and directly acts on the obstruction, it will not cause thermal damage to the surrounding normal soft tissue. Therefore, the forward burst wave of the present application for treating occlusive lesions The generation system breaks up obstructions more safely and effectively.
  • Figure 1 is a schematic structural diagram of a forward burst wave generation system for treating occlusive lesions according to a specific embodiment of the present application.
  • FIG. 2 is a schematic structural diagram of the distal end of the forward burst wave generating system for treating occlusive lesions shown in FIG. 1 .
  • Figure 3 is a waveform diagram of a burst wave generated by a specific embodiment of the present application.
  • FIG. 4 is a waveform diagram of a single pulse wave in the burst wave shown in FIG. 3 .
  • Figure 5 is a waveform diagram of the shock wave.
  • Figure 6 is a schematic structural diagram of a burst wave generator according to a specific embodiment of the present application.
  • Burst wave generator 210. Pulse waveform generation module; 220. Connector module; 230. Transducer matching module; 240. Power amplification module; 250. Operation control module;
  • a forward burst wave generation system 10 for treating occlusive lesions, including a catheter assembly 100, a burst wave generator 200, a forward transducer 300 and a connecting wire 400.
  • the catheter assembly 100 includes a catheter body 110 and a guide wire 120.
  • the end of the catheter body 110 close to the operator is the proximal end, and the end of the catheter body 110 used to enter the blood vessel is the distal end; the proximal end of the catheter body 110 is provided with a guidewire interface 111 and wire interface 112.
  • the catheter body 110 is provided with mutually independent guide wire lumens and wire lumens.
  • the guide wire interface 111 is connected to the guide wire lumen, the wire cavity is connected to the wire interface 112, and the guide wire 120 is connected to the guide wire interface 111.
  • the guide wire 120 guides the movement of the catheter body 110
  • the connecting wire 400 is accommodated in the guide wire cavity
  • the forward transducer 300 is disposed at the distal end of the catheter body 110
  • the burst wave occurs.
  • the device 200 is disposed at the proximal end of the catheter body 110.
  • One end of the connecting wire 400 extends from the wire interface 112 and is electrically connected to the burst wave generator 200.
  • the other end of the connecting wire 400 is electrically connected to the forward transducer 300.
  • the forward transducer 300 is used to convert the signal of the burst wave generator 200 into a burst wave.
  • the burst wave propagates forward along the axial direction of the catheter body 110.
  • the burst wave includes multiple single pulse waves.
  • the wave consists of multiple consecutive simple harmonic vibration cycles, and the center frequency of the pulse wave is 50 kHz ⁇ 15MHz, pulse wave duration is 5 ⁇ s ⁇ 800 ⁇ s, the repetition frequency of the burst wave (the number of pulse waves completed per unit time) is 20 Hz ⁇ 5000 Hz.
  • the distal end of the catheter body 110 is placed in the blood vessel, the guide wire 120 guides the movement of the catheter body 110, and guides the distal end of the catheter body 110 to the CTO lesion area, and then the burst wave generator 200 is connected to the forward direction.
  • the transducer 300 is electrically connected, and the burst wave generator 200 is turned on.
  • the forward transducer 300 converts the signal of the burst wave generator 200 into a burst wave.
  • the burst wave is conducted to the obstruction, and repeated mechanical force is applied to the obstruction until it is crushed. Blockage.
  • the frequency of the burst wave in this application is relatively high, which generates a mechanical wave with a shorter wavelength that propagates forward along the axial direction of the catheter body 110. It can provide repeated forward mechanical force to directly act on the obstruction in the blood vessel without producing thermal effects and causing no damage to the surroundings.
  • the burst wave conducted to the obstruction is high frequency (50 kHz ⁇ 15MHz), short duration (5 ⁇ s ⁇ 800 ⁇ s), can directly act on the obstruction, splitting the obstruction into tiny particles (5 ⁇ m ⁇ 20 ⁇ m), thereby eliminating the obstruction, and the fragmented tiny particles can enter the blood circulation due to their smaller particle size and be transported by the liver , phagocytes in the spleen and lungs are cleared without causing secondary obstruction.
  • the single burst wave of the present application has a short duration, low duty cycle, and directly acts on the obstruction, it will not cause thermal damage to the surrounding normal soft tissue. Therefore, the forward direction of the present application for treating occlusive lesions is The burst wave generation system 10 can break up obstructions more safely and effectively.
  • This application can control the size of the force by setting the emission energy (voltage and repetition frequency), and set the emission frequency to control the size of the broken particles to meet the needs of treating CTO lesions, plaques of different hardness and thrombus.
  • the working principle of ultrasonic cavitation plaque ablation in the prior art is: ultrasonic waves first cavitate the liquid around it, causing the generated microbubbles to continuously expand and implode. The implosion generates impact and thermal effects to block the plaque. Material ablation.
  • the disadvantages of this technology are: the ultrasonic energy used to produce ultrasonic cavitation effect is relatively large, resulting in significant thermal effects, and the size, direction and scope of the impact force generated by implosion are uncontrollable, and it is easy to damage normal soft tissues in blood vessels.
  • the burst wave of this application mainly directly provides repeated mechanical force to the obstruction, and uses mechanical effects to crack the obstruction. There is no cavitation effect and no thermal effect. The size, direction and scope of the mechanical force that directly acts on the obstruction can be all. Therefore, the burst wave of the present application can eliminate obstructions more safely and effectively.
  • the shock wave used in the shock wave fragmentation technique in the prior art is shown in Figure 5.
  • the shock wave decays exponentially with time.
  • the voltage of the shock wave generated is at least thousands of volts and the current is at least several hundred amperes.
  • There is a risk of high-voltage electrical leakage. the instantaneous maximum impact force of the shock wave is large, and it is easy to damage the device and blood vessels.
  • the particle size of the diseased block broken by the shock wave is larger than that of the burst wave, which can easily lead to secondary blockage. Therefore, the burst wave of the present application can eliminate obstructions more safely and effectively than the shock wave.
  • the peak sound pressure of the burst wave is less than 20 MPa; the duty cycle of the burst wave is 0.1% ⁇ 10%.
  • This application uses forward burst waves with high frequency, short duration, high repetition frequency and low duty cycle to provide controllable, repetitive and uniform mechanical force to directly act on the obstruction, fully cracking it into tiny particles. particles (5 ⁇ m ⁇ 20 ⁇ m), thereby eliminating obstructions without damaging normal vascular soft tissue or causing thermal damage.
  • the forward transducer 300 is a piezoelectric transducer, and the piezoelectric transducer vibrates along its thickness direction.
  • the thickness direction of the piezoelectric transducer is along the axial direction of the catheter body 110.
  • the piezoelectric transducer vibrates along the axial direction of the catheter body 110. After receiving the electrical signal, the transducer will vibrate in the direction of its thickness.
  • the vibration direction is single, making it easier to accurately control the propagation direction, area of action, burst wave pressure and uniformity with low loss.
  • the end surface of the piezoelectric transducer is provided in a spherical shape that is concave toward the proximal end of the catheter body 110, which can produce a sound focusing effect toward the front of the distal end of the catheter body 110 and produce a larger sound. mechanical force, and improve the efficiency of acoustic-to-electrical conversion.
  • the end face of the piezoelectric transducer can also be flat.
  • the focal length of the piezoelectric transducer is set to 0.5 mm to 3 mm.
  • the forward transducer 300 is a multi-layered structure that is sequentially stacked along the axial direction of the catheter body 110, from the proximal end of the catheter body 110 to the distal end of the catheter body 110.
  • the forward transducer 300 includes a backing layer 310, a first electrode layer 320, a piezoelectric material layer 330, a second electrode layer 340 and a matching layer 350 in sequence.
  • the backing layer 310 is used to absorb the vibration of the piezoelectric material layer 330.
  • the energy radiated into the interior of the tube body 110 prevents energy reflection from interfering with the direction and pressure of the burst wave.
  • the first electrode layer 320 and the second electrode layer 340 provide driving voltages for the piezoelectric material layer 330 through the connecting wires 400 respectively.
  • the positive and negative electrodes of the burst wave generator 200 are electrically connected.
  • the matching layer 350 is used to match the acoustic impedance of the intravascular obstruction to avoid loss of acoustic wave efficiency.
  • the piezoelectric material layer 330 will vibrate in its thickness direction after receiving the electrical signal. to produce a blast wave.
  • the material of the piezoelectric material layer 330 may be a piezoelectric single crystal, a polycrystalline piezoelectric ceramic, a polymer piezoelectric material, or a polymer-piezoelectric ceramic composite material.
  • the operating frequency of the piezoelectric material layer 330 is related to its size. The thinner the piezoelectric material layer 330 is, the higher the operating frequency is. In this application, the thickness of the piezoelectric material layer 330 may be 0.2 mm ⁇ 5 mm to provide high-frequency burst waves.
  • the application randomly arranges piezoelectric ceramic columns in a polymer (specifically, epoxy resin) to make a type 1-3 piezoelectric composite material. After the polymer is cured, the piezoelectric ceramic columns are formed in a direction perpendicular to the ceramic columns. Cut and prepare 1-3 type piezoelectric composite material layers of required thickness. The random distribution of piezoelectric ceramic columns can well suppress its transverse vibration mode and increase its longitudinal electromechanical conversion efficiency.
  • a polymer specifically, epoxy resin
  • the backing layer 310 may be an epoxy resin layer doped with a sound wave attenuating additive, and the sound wave attenuating additive may be selected from tungsten powder and/or alumina powder, etc.
  • the first electrode layer 320 and the second electrode layer 340 are respectively metal conductive layers.
  • the material of the metal conductive layer can be gold, silver, platinum, copper, etc. specifically.
  • the matching layer 350 may be an epoxy resin layer doped with dense powder, and the dense powder may be selected from alumina powder and/or glass powder.
  • the spherical piezoelectric transducer of this application is prepared using spherical pressure focusing technology.
  • a convex spherical component with a predetermined radius of curvature is used to exert pressure on the piezoelectric material layer 330, thereby deforming the piezoelectric material layer 330 itself.
  • the depression forms a concave spherical shape.
  • the mold is cooled and solidified at room temperature and then taken out to obtain a spherical piezoelectric transducer.
  • the depression at the forward end of the spherical piezoelectric transducer is filled with a sound-conducting material 370.
  • the sound-conducting material 370 can be an insulating material such as polyimide, polyetheretherketone, PEBA, PET, FEP, or PTFE.
  • the distal end of the catheter body 110 is provided with an opening, and the distal end of the catheter body 110 is provided with an accommodation cavity 140 for communicating with the opening.
  • the forward transducer 300 Disposed in the accommodation cavity 140, the forward transducer 300 is recessed toward the interior of the conduit body 110, and the sound guide material 370 is filled in the recess 360, which not only seals the opening, but also avoids gaps between the forward transducer 300 and the obstruction. .
  • the inner diameter of the accommodation cavity 140 is 0.2 mm ⁇ 3 mm, that is, the diameter of the forward transducer 300 is 0.2 mm ⁇ 3 mm.
  • the shape of the piezoelectric transducer can adopt a variety of structures, such as single array element, multiple array elements, circular tube, flat plate, area array, ring array, focusing, non-focusing, etc.
  • the catheter assembly 100 further includes a radioactive marking ring 130.
  • the radioactive marking ring 130 is set on the catheter body 110.
  • the radioactive marking ring 130 is located at the distal end of the catheter body 110.
  • the radioactive marker ring 130 is positioned on a side of the forward transducer 300 close to the proximal end of the catheter body 110 .
  • the radiomarking ring 130 is used for X-ray imaging to accurately locate the active area of the forward transducer 300 during surgery.
  • the radiomarking ring 130 is embedded into the catheter body 110 to reduce the outer diameter of the working section of the catheter body 110 .
  • the radioactive labeling ring 130 may be an X-ray opaque metal ring, specifically made of metal materials such as gold, platinum, molybdenum, tungsten, or platinum-iridium alloy.
  • 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 connector module 220 respectively.
  • the connector module 220 has a high-voltage pulse signal terminal and is connected to the forward transducer 300 through the high-voltage pulse signal terminal.
  • the pulse waveform generation module 210 supports multi-channel waveform transmission and can correspond to multiple forward transducers 300.
  • 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 forward transducer 300 to transmit a pulse signal to generate a burst wave.
  • 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 waveform generation module 210 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 Amplify 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 forward 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. .

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Abstract

一种治疗闭塞性病变的前向爆裂波发生系统（10），包括导管体（110）和前向换能器（300）；前向换能器（300）设置于导管体（110）的远端，前向换能器（300）用于振动产生爆裂波，爆裂波沿导管体（110）轴向向前传播；爆裂波包括多个单次脉冲波，脉冲波包括连续多个简谐振动周期，脉冲波的频率为50kHz～15MHz，持续时间为5μs～800μs，重复频率为20Hz～5000Hz。治疗闭塞性病变的前向爆裂波发生系统（10）利用高频率、短持续时间、高重复频率的前向爆裂波产生重复机械力，直接作用于血管内阻塞物，使阻塞物充分裂解为微小颗粒，同时，不产生热效应，不损伤血管内正常组织。

Description

治疗闭塞性病变的前向爆裂波发生系统 技术领域
本申请涉及医疗器械技术领域，更具体地，涉及一种治疗闭塞性病变的前向爆裂波发生系统。
 背景技术
动脉慢性完全闭塞病变（Chronic total occlusion，CTO）是指动脉管腔完全闭塞，TIMI血流0级，且病史大于3个月的病变。CTO病变的形成通常从动脉粥样硬化易损斑块的破裂开始，在破裂斑块两端形成血栓，当血栓逐渐变得纤维化并逐渐坚硬且病理性，同时随着时间的延长，最终导致动脉血管腔完全闭塞。血管内阻塞物通常由动脉粥样硬化斑块和陈旧性血栓两种组织构成。
 技术问题
血管介入治疗是CTO患者较佳的治疗方式，目前CTO病变的血管介入治疗方法主要有：①CTO专用导丝和导管通过技术，包括正向导丝技术（Antegrade wire entry，AWE）、正向夹层再入真腔技术（Antegrade dissection/ re-entry，ADR）、逆向导丝技术（Retrograde wire escalation，RWE），正向导丝技术是使用不同硬度的导丝正向通过CTO 病变；正向夹层再入真腔技术指手术操作中人为造成内膜下钝性撕裂，使导丝从内膜下前行跨越闭塞段，进入远端血管真腔；逆向导丝技术常选用复合轴心设计的亲水涂层导丝在治疗闭塞性病变的前向爆裂波发生系统支持下经逆向侧支循环到达闭塞远端，操控逆向导丝穿过病变远端纤维帽到达病变近端与前向导丝交会并引导前向导丝通过闭塞段。但是使用上述传统导丝和导管开通仅能达到约50％的开通率，手术复杂，需要术者和患者长时间暴露在射线下，围术期并发症风险高，如卒中、冠状动脉穿孔、夹层、心包填塞、放射性皮肤损伤、对比剂肾病等；②单纯球囊扩张血管成形术(Percutaneous transluminal balloon catheter angioplasty, PTCA），通过球囊膨胀扩张管腔，夹层发生率高，易对血管壁造成损伤；③旋切或机械钻孔导管技术，使用可旋转打开的钳状结构，通过手柄控制钳状结构张合，夹紧斑块，使用旋转的转头将管腔内粥样硬化斑块、钙化组织碾磨成极细的微粒，从而将阻塞的管腔斑块消除，但存在极大的风险，第一，夹紧斑块时易导致斑块钝性撕裂，第二，需要经验极其丰富的医生使用，若治疗过程中发生偏移极有可能穿过血管；第三，操作复杂，不适用于小血管病变，对迂曲病变效果不佳且价格较昂贵；④准分子激光斑块消融术（Excimer laser coronary atherectomy, ELCA），激光以脉冲方式作用于组织，通过光化学作用破坏分子键，光热学作用产生热能，光机械作用产生动能，将钙化斑块裂解为微小颗粒，但操作复杂，对迂曲病变效果不佳且价格较昂贵；⑤超声空化斑块消蚀成形术，将电能转换成超声波振动能量，产生空化效应，使微气泡在导管的头端膨胀和内爆，破坏斑块的内部结构，侵蚀CTO的固体表面，从而自动选择性地消融斑块，但产生空化效应的超声能量较大，会产生显著热效应，易造成血管内正常软组织的热损伤；⑥冲击波碎裂术，在两电极间施加高压电场，电极放电使液体迅速汽化、膨胀，产生空穴气泡或冲击波作用于CTO病变区域，清除阻塞物或打孔。该方案的缺点是：第一，难以精准控制传导区域、产生冲击力的方向以及均匀一致性；第二，冲击力随距离而发生指数级衰减，要想使作用于球囊的单次冲击压达50 atm左右时，则需在电极之间施加上千伏电压以及几百安电流，如此高压电易损耗装置，且存在高压电漏电风险；第三，冲击波作用范围较小，冲击波碎裂钙化斑块的粒径较大。因此，如何安全、有效地治疗CTO病变仍然是临床面临的巨大挑战。
 技术解决方案
本申请的目的在于克服现有技术存在的上述缺陷，提供一种治疗闭塞性病变的前向爆裂波发生系统，利用高频率、短持续时间、高重复频率的前向爆裂波产生重复机械力，直接作用于血管内阻塞物，使阻塞物充分裂解为微小颗粒，同时，不产生热效应，不损伤血管内正常软组织。
为实现上述目的，本申请的技术方案如下：
一种治疗闭塞性病变的前向爆裂波发生系统，包括导管体和前向换能器；
所述导管体的靠近操作者的一端为近端，所述导管体的用于进入血管的一端为远端；
所述前向换能器设置于所述导管体的远端的端部，所述前向换能器用于振动产生爆裂波，所述爆裂波沿所述导管体轴向向前传播；
所述爆裂波包括多个脉冲波，所述脉冲波包括连续多个简谐振动周期，所述脉冲波的频率为50 kHz~15 MHz，所述脉冲波的持续时间为5 μs~800 μs，所述爆裂波的重复频率为20 Hz~5000 Hz。
 有益效果
实施本申请实施例，将具有如下有益效果：
本申请采用爆裂波对血管内阻塞物进行碎裂的原理为：采用相对较高的频率传递的声波来循环地对阻塞物施加重复机械力，直到粉碎阻塞物。
本申请的爆裂波能提供重复前向机械力直接作用于血管内阻塞物，且不产生热效应，不对周围的正常软组织造成热损伤；同时，被传导至阻塞物的爆裂波为高频（50 kHz~15MHz）、短持续时间（5 μs~800 μs）的超声波，能够直接作用于阻塞物，使阻塞物裂解为微小颗粒（5 μm ~ 20 μm），从而消除阻塞物，且碎裂的微小颗粒由于粒径较小，可进入血液循环，并由肝、脾及肺内的吞噬细胞清除，不会造成二次阻塞。由于本申请的爆裂波持续时间短，占空比低，且直接作用于阻塞物，因此，也不会对周围的正常软组织造成热损伤，因此，本申请的治疗闭塞性病变的前向爆裂波发生系统能够更安全、更有效的破碎阻塞物。
 附图说明
为了更清楚地说明本申请实施例或现有技术中的技术方案，下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本申请的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
其中：
图1是本申请一具体实施例的治疗闭塞性病变的前向爆裂波发生系统的结构示意图。
图2是图1所示的治疗闭塞性病变的前向爆裂波发生系统的远端端部的结构示意图。
图3是本申请一具体实施例产生的爆裂波的波形图。
图4是图3所示的爆裂波中的单次脉冲波的波形图。
图5是冲击波的波形图。
图6是本申请一具体实施例的爆裂波发生器的结构示意图。
附图标记：
10、治疗闭塞性病变的前向爆裂波发生系统；
100、导管组件；110、导管体；111、导丝接口；112、导线接口；120、导引导丝；130、放射标记环；140、容纳腔；
200、爆裂波发生器；210、脉冲波形发生模块；220、连接器模块；230、换能器匹配模块；240、功率放大模块；250、操作控制模块；
300、前向换能器；310、背衬层；320、第一电极层；330、压电材料层；340、第二电极层；350、匹配层；360、凹陷；370、导声材料；
400、连接导线。
 本发明的实施方式
下面将结合本申请实施例中的附图，对本申请实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本申请一部分实施例，而不是全部的实施例。基于本申请中的实施例，本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例，都属于本申请保护的范围。
参考图1和图2，本申请公开了一种治疗闭塞性病变的前向爆裂波发生系统10，包括导管组件100、爆裂波发生器200、前向换能器300和连接导线400，导管组件100包括导管体110和导引导丝120，导管体110的靠近操作者的一端为近端，导管体110的用于进入血管的一端为远端；导管体110的近端设有导丝接口111和导线接口112，导管体110内设有互相独立的导丝腔和导线腔，导丝接口111与导丝腔相连通，导线腔与导线接口112相连通，导引导丝120从导丝接口111进入并容纳于导丝腔，导引导丝120对导管体110的移动进行导向，连接导线400容纳于导线腔，前向换能器300设置于导管体110的远端的端部，爆裂波发生器200设置于导管体110的近端，连接导线400的一端从导线接口112伸出与爆裂波发生器200电连接，连接导线400的另一端与前向换能器300电连接，前向换能器300用于将爆裂波发生器200的信号转换为爆裂波，爆裂波沿所述导管体110轴向向前传播，参考图3和图4，爆裂波包括多个单次脉冲波，脉冲波包括连续多个简谐振动周期，脉冲波的中心频率为50 kHz~15MHz，脉冲波的持续时间为5 μs~800 μs，爆裂波的重复频率（单位时间内完成脉冲波的次数）为20 Hz~5000 Hz。
使用时，将导管体110的远端置于血管中，导引导丝120对导管体110的移动进行导向，引导导管体110的远端到达CTO病变区域，然后将爆裂波发生器200与前向换能器300电连接，打开爆裂波发生器200，前向换能器300将爆裂波发生器200的信号转化为爆裂波，爆裂波传导至阻塞物，对阻塞物施加重复机械力，直至粉碎阻塞物。
本申请的爆裂波的频率较高，产生了沿导管体110轴向向前传播的波长较短的机械波，能提供重复前向机械力直接作用于血管内阻塞物，且不产生热效应，不对周围的正常软组织造成热损伤；同时，被传导至阻塞物的爆裂波为高频（50 kHz~15MHz）、短持续时间（5 μs~800 μs），能够直接作用于阻塞物，使阻塞物裂解为微小颗粒（5 μm ~ 20 μm），从而消除阻塞物，且碎裂的微小颗粒由于粒径较小，可进入血液循环，并由肝、脾及肺内的吞噬细胞清除，不会造成二次阻塞。由于本申请的单次爆裂波持续时间短，占空比低，且直接作用于阻塞物，因此，也不会对周围的正常软组织造成热损伤，因此，本申请的治疗闭塞性病变的前向爆裂波发生系统10能够更安全、更有效的破碎阻塞物。
本申请可通过设置发射能量（电压和重复频率）来控制作用力的大小，设置发射频率来控制破碎颗粒的大小，以满足治疗CTO病变 不同硬度斑块和血栓的需求。
现有技术中的超声空化斑块消蚀成形术，其作用原理是：超声波先将其周围的液体空化，使产生的微气泡不断膨胀和内爆，内爆产生冲击力和热效应使阻塞物消融，该技术的缺点是：产生超声空化效应所使用的超声能量较大，产生显著热效应，且内爆产生的冲击力的大小、方向和作用范围均不可控，易损伤血管内正常软组织。然而，本申请的爆裂波主要直接对阻塞物提供重复机械力，利用机械效应裂解阻塞物，无空化效应，不产生热效应，且直接作用阻塞物的机械力的大小、方向和作用范围均可控，因此，本申请的爆裂波可更安全、更有效的消除阻塞物。
现有技术中的冲击波碎裂术所使用的冲击波，如图5所示，冲击波随时间延长呈指数级衰减，产生冲击波的电压至少上千伏，电流至少几百安，存在高压电漏电风险，冲击波的瞬时最高冲击力较大，易损伤装置和血管，冲击波破碎的病变块的粒径相比爆裂波更大，易导致二次堵塞。因此，本申请的爆裂波相比冲击波，也可更安全、更有效的消除阻塞物。
进一步的，爆裂波的峰值声压小于20 MPa；爆裂波的占空比为0.1% ~ 10%，本申请利用高频率、短持续时间、高重复频率以及低占空比的前向爆裂波，提供可控、重复、均匀的机械力直接作用于阻塞物，使其充分裂解为微小颗粒（5 μm ~ 20 μm），从而将阻塞物消除，而不损伤正常的血管软组织，不产生热损伤。
在一优选实施例中，前向换能器300为压电换能器，压电换能器沿其厚度方向振动，压电换能器的厚度方向为沿导管体110的轴向，压电换能器在接收到电信号后会在其厚度方向上振动，振动方向单一，更易于精准控制爆裂波的传播方向、作用区域、爆裂波压力大小和均匀一致性，且损耗小。
进一步的，在一优选实施例中，设置压电换能器的端面呈向导管体110的近端凹陷的球面型，可向导管体110的远端的前向产生声聚焦效果，产生更大机械力，以及提高声电转化效率。当然，压电换能器的端面也可以为平面型。
进一步的，当压电换能器的端面呈向导管体的近端凹陷的球面型时，设置压电换能器的焦距为0.5 mm~3 mm。
参考图2，具体的，在一具体实施例中，前向换能器300为沿导管体110轴向依次层叠的多层叠结构，从导管体110的近端到导管体110的远端的方向，前向换能器300依次包括背衬层310、第一电极层320、压电材料层330、第二电极层340和匹配层350，背衬层310用于吸收压电材料层330因振动而往导管体110的内部辐射的能量，防止能量反射对爆裂波的方向和压力造成干扰，第一电极层320和第二电极层340为压电材料层330提供驱动电压，分别通过连接导线400电连接爆裂波发生器200的正极和负极，匹配层350用于与血管内阻塞物声阻抗匹配，避免声波效率损失，压电材料层330在接收到电信号后会在其厚度方向上振动，以产生爆裂波。
具体的，压电材料层330的材料可以为压电单晶体、多晶体压电陶瓷、高分子压电材料或聚合物-压电陶瓷复合材料等。压电材料层330的工作频率与其尺寸有关，压电材料层330越薄，工作频率越高。在本申请中，压电材料层330的厚度可以为0.2 mm~5 mm，以能提供高频的爆裂波。
在本具体实施例中，本申请将压电陶瓷柱随机排列于聚合物（具体为环氧树脂）中制成1-3型压电复合材料，聚合物固化后，在垂直于陶瓷柱的方向切割制备成所需厚度的1-3型压电复合材料层。压电陶瓷柱的随机分布可以很好地抑制其横向振动模式，增大其纵向机电转换效率。
背衬层310可以为掺杂声波衰减添加物的环氧树脂层，声波衰减添加物可以选自钨粉和/或氧化铝粉等。
第一电极层320和第二电极层340分别为金属导电层，金属导电层的材料具体可以为金、银、铂、铜等。
匹配层350可以为掺杂致密粉末的环氧树脂层，致密粉末可以选自氧化铝粉和/或玻璃粉等。
本申请的球面型压电换能器采用球压聚焦技术制备，在高温环境下，用预定曲率半径的凸球面部件对压电材料层330施加压力，从而使压电材料层330自身发生形变，凹陷形成凹球面型，模具在室温中冷却固化后取出，得到球面型的压电换能器。
球面型压电换能器的前向端部的凹陷处填充导声材料370，导声材料370可以为聚酰亚胺、聚醚醚酮、PEBA、PET、FEP或PTFE等绝缘材料。
参考图2，在本申请的具体实施例中，导管体110的远端的端部设有开口，导管体110的远端设有用于与开口相连通的容纳腔140，前向换能器300设置于容纳腔140内，前向换能器300向导管体110的内部凹陷，在凹陷360内填充导声材料370，不仅密封开口，而且避免前向换能器300与阻塞物之间有间隙。
在本申请中，容纳腔140的内径为0.2 mm~3 mm，即前向换能器300的直径为0.2 mm~3 mm。
压电换能器的形状可采用多种结构，例如单阵元、多阵元，圆管状、平板状、面阵，环阵，聚焦、非聚焦等。
参考图1，在一具体实施例中，导管组件100还包括放射标记环130，放射标记环130套设于导管体110上，放射标记环130位于导管体110的远端，具体的，在本申请中，设置放射标记环130位于前向换能器300的靠近导管体110的近端的一侧。放射标记环130用于X射线显影，术中精确定位前向换能器300的作用区域。优选的，将放射标记环130嵌入导管体110内，减小导管体110工作段的外径。放射标记环130可以为不透X射线的金属环，具体可以为金、铂、钼、钨或铂铱合金等金属材料制造。
参阅图6所示，爆裂波发生器200包括脉冲波形发生模块210、连接器模块220和换能器匹配模块230，换能器匹配模块230分别信号连接于脉冲波形发生模块210和连接器模块220，连接器模块220具有高压脉冲信号端，并通过高压脉冲信号端连接于前向换能器300。
在本实施例中，脉冲波形发生模块210支持多通道波形发送，可对应多个前向换能器300，每个通道的时序和波形参数均可独立控制。激励时序控制由可编程逻辑器件（FPGA）完成，脉冲的基本参数包括频率、个数、占空比、重复频率等都可以进行编程控制；连接器模块220设置有高压脉冲信号端，并通过高压脉冲信号端与导管体110的连接接口113连接，以提供前向换能器300发射脉冲信号产生爆裂波。具体地，换能器匹配模块230包括电感、电容、电阻，将输出电阻匹配到50欧姆，并与连接器模块220信号连接。
进一步地，爆裂波发生器200还包括功率放大模块240，功率放大模块240分别连接于脉冲波形发生模块210和换能器匹配模块230；功率放大模块240包括增益控制模块和场效应晶体管，并用于放大脉冲波发生模块发出的信号。
在本实施例中，功率放大模块240由接收前端脉冲波形发生模块210产生的信号进行幅度放大，再送至功率金属-氧化物半导体场效应晶体管进行功率放大，二者信号连接于可编程逻辑器件并受其控制，放大后的波形输出给阻抗匹配电路，并传导至前向换能器300生成爆裂波。
在一实施例中，爆裂波发生器200还包括操作控制模块250，操作控制模块250分别信号连接于脉冲波形发生模块210和连接器模块220，并用于控制脉冲波形发生模块210的启动或关闭。
具体地，操作控制模块250可以为操作手柄或脚踏板，并信号连接于可编程逻辑器件，使用时可以将按键指令进行编译，通过控制信号对脉冲波形发生模块210进行相应控制以实现对应功能。
以上所述实施例仅表达了本申请的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对申请专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本申请构思的前提下，还可以做出若干变形和改进，这些都属于本申请的保护范围。因此，本申请专利的保护范围应以所附权利要求为准。

Claims (9)

  1. 一种治疗闭塞性病变的前向爆裂波发生系统，其特征在于，包括导管体和前向换能器；
    所述导管体的靠近操作者的一端为近端，所述导管体的用于进入血管的一端为远端；
    所述前向换能器设置于所述导管体的远端的端部，所述前向换能器用于振动产生爆裂波，所述爆裂波沿所述导管体轴向向前传播；
    所述爆裂波包括多个脉冲波，所述脉冲波包括连续多个简谐振动周期，所述脉冲波的频率为50 kHz~15MHz，所述脉冲波的持续时间为5 μs~800 μs，所述爆裂波的重复频率为20 Hz~5000 Hz。
  2. 根据权利要求1所述的治疗闭塞性病变的前向爆裂波发生系统，其特征在于，所述爆裂波的峰值声压小于20 MPa；
    所述爆裂波的占空比为0.1%~10%。
  3. 根据权利要求1所述的治疗闭塞性病变的前向爆裂波发生系统，其特征在于，所述前向换能器为压电换能器。
  4. 根据权利要求3所述的治疗闭塞性病变的前向爆裂波发生系统，其特征在于，所述压电换能器的端面呈向所述导管体的近端凹陷的球面型或平面型。
  5. 根据权利要求4所述的治疗闭塞性病变的前向爆裂波发生系统，其特征在于，当所述压电换能器的端面呈向所述导管体的近端凹陷的球面型时，所述压电换能器的焦距为0.5 mm~3 mm。
  6. 根据权利要求3或4或5所述的治疗闭塞性病变的前向爆裂波发生系统，其特征在于，从所述导管体的近端到所述导管体的远端的方向，所述压电换能器依次包括背衬层、第一电极层、压电材料层、第二电极层和匹配层，所述背衬层用于吸收所述压电材料层因振动而往所述导管体内部辐射的能量，所述第一电极层和所述第二电极层用于为所述压电材料层提供驱动电压，所述匹配层用于声阻抗匹配。
  7. 根据权利要求1所述的治疗闭塞性病变的前向爆裂波发生系统，其特征在于，其满足以下特征a~d中的至少一个：
    a. 还包括放射标记环，所述放射标记环套设于所述导管体上，所述放射标记环位于所述导管体的远端；
    b. 还包括导引导丝，所述导管体内设有导丝腔，所述导管体的近端设有导丝接口，所述导丝接口与所述导丝腔相连通；所述导引导丝从所述导丝接口进入并容纳于所述导丝腔，所述导引导丝对所述导管体的移动进行导向；
    c. 还包括爆裂波发生器，所述爆裂波发生器设置于所述导管体的近端，所述爆裂波发生器为所述前向换能器提供电信号，所述前向换能器根据所述电信号发生振动产生所述爆裂波；
    d. 还包括连接导线，所述导管体内设有导线腔，所述导管体的近端设有导线接口，所述导线接口与所述导线腔相连通，所述连接导线容纳于所述导线腔，所述连接导线用于为所述前向换能器提供驱动电信号。
  8. 根据权利要求7所述的治疗闭塞性病变的前向爆裂波发生系统，其特征在于，所述爆裂波发生器包括脉冲波形发生模块、连接器模块和换能器匹配模块，所述换能器匹配模块分别信号连接于所述脉冲波形发生模块和所述连接器模块，所述连接器模块具有高压脉冲信号端，并通过所述高压脉冲信号端连接于所述换能器。
  9. 根据权利要求8所述的治疗闭塞性病变的前向爆裂波发生系统，其特征在于，其满足以下特征a~b中的至少一个：
    a. 所述爆裂波发生器还包括功率放大模块，所述功率放大模块分别连接于所述脉冲波形发生模块和所述换能器匹配模块；
    b. 所述爆裂波发生器还包括操作控制模块，所述操作控制模块分别信号连接于所述脉冲波形发生模块和所述连接器模块，并用于控制所述脉冲波形发生模块的启动或关闭。
PCT/CN2022/104870 2022-07-01 2022-07-11 治疗闭塞性病变的前向爆裂波发生系统 WO2024000633A1 (zh)

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1774920A1 (en) * 2004-06-21 2007-04-18 Hiroshi Furuhata Ultrasonic brain infarction treating device
US20080294037A1 (en) * 2007-05-23 2008-11-27 Jacob Richter Apparatus and Method for Guided Chronic Total Occlusion Penetration
CN104161548A (zh) * 2014-08-27 2014-11-26 马永红 一种治疗动脉闭塞病变的器具及其应用
US10251657B1 (en) * 2013-05-02 2019-04-09 University Of Washington Through Its Center For Commercialization Noninvasive fragmentation of urinary tract stones with focused ultrasound
US20200100832A1 (en) * 2017-06-14 2020-04-02 Olympus Corporation Treatment system
US20210187330A1 (en) * 2018-08-16 2021-06-24 University Of Washington Apparatus and method for ultrasound beam shaping

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1774920A1 (en) * 2004-06-21 2007-04-18 Hiroshi Furuhata Ultrasonic brain infarction treating device
US20080294037A1 (en) * 2007-05-23 2008-11-27 Jacob Richter Apparatus and Method for Guided Chronic Total Occlusion Penetration
US10251657B1 (en) * 2013-05-02 2019-04-09 University Of Washington Through Its Center For Commercialization Noninvasive fragmentation of urinary tract stones with focused ultrasound
CN104161548A (zh) * 2014-08-27 2014-11-26 马永红 一种治疗动脉闭塞病变的器具及其应用
US20200100832A1 (en) * 2017-06-14 2020-04-02 Olympus Corporation Treatment system
US20210187330A1 (en) * 2018-08-16 2021-06-24 University Of Washington Apparatus and method for ultrasound beam shaping

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