WO2022120836A1 - Irreversible sonoporation device and apparatus, and computer readable storage medium - Google Patents

Abstract

An irreversible sonoporation device and apparatus, and a computer readable storage medium, relating to the medical field. The device comprises an ultrasonic intervention module, an ultrasonic electronic excitation module, an ultrasonic imaging monitoring module, and a control module. The ultrasonic electronic excitation module generates an excitation signal of ultrasonic waves. The ultrasound intervention module emits ultrasonic waves that can be focused on a region of interest to generate a cloud of cavitation bubbles in the region of interest of a target tissue. A plurality of irreversible pore channels are formed on outer membranes of biological cells by means of the cavitation effect, and internal and external water balance of the cells is destroyed, so that apoptosis of the cells is caused, the purpose of ablating biological tissues is realized, and the problem of thermal deposition caused by a thermal effect can be avoided. Moreover, the device has a small damage to surrounding tissues, the integrity of cell matrixes and other structures around the cells can be retained, pain caused by electroporation treatment is reduced, and complications caused by high-voltage electric pulse are avoided. Accurate control of ablation is performed by the monitoring imaging module and the control module.

Description

不可逆声穿孔设备、装置及计算机可读存储介质Irreversible acoustic perforation device, device and computer readable storage medium 技术领域technical field

本申请属于医疗领域，尤其涉及不可逆声穿孔设备、装置及计算机可读存储介质。The present application belongs to the medical field, and particularly relates to irreversible acoustic perforation equipment, devices and computer-readable storage media.

背景技术Background technique

肿瘤是一类常见病，多发病，其中恶性肿瘤是目前危害人类健康和生命最严重的一类疾病。传统的治疗手段为手术治疗、放射治疗和化学治疗，这些方法由于会给患者留下较大创伤，容易复发转移，并且会出现相应的适应症、禁忌症和副作用等弊端。Tumor is a common and frequently-occurring disease, among which malignant tumor is the most serious type of disease that endangers human health and life. The traditional treatment methods are surgery, radiotherapy and chemotherapy. These methods are prone to recurrence and metastasis due to the large trauma to the patient, and there are corresponding indications, contraindications and side effects.

近年来，随着靶向、免疫、微创消融等精准治疗技术在临床得到广泛的应用。其中，肿瘤的微创消融术是在医学影像引导下对肿瘤定位，采取局部的物理或化学的方法，直接杀灭肿瘤组织。其以缩短住院时间、对患者身体损伤小等优点成为肿瘤治疗的新手段之一。In recent years, precision treatment technologies such as targeting, immunization, and minimally invasive ablation have been widely used in clinical practice. Among them, the minimally invasive ablation of tumors is to locate the tumor under the guidance of medical images, and use local physical or chemical methods to directly kill the tumor tissue. It has become one of the new methods of tumor treatment with the advantages of shortening the hospitalization time and causing little damage to the patient's body.

传统的消融术包括：射频消融、微波消融、高强度聚焦超声消融(High Intensity Focused Ultrasound,HIFU)、激光消融、氩氦刀消融等。传统的消融技术主要采用的是热消融，导致肿瘤靠近胃肠道、胆管、尿道、神经等重要组织时成为消融禁区，且大血管也因“热沉降”效应而影响疗效。Traditional ablation techniques include: radiofrequency ablation, microwave ablation, High Intensity Focused Ultrasound (HIFU), laser ablation, and argon-helium knife ablation. The traditional ablation technique mainly uses thermal ablation, which makes the tumor close to the gastrointestinal tract, bile duct, urethra, nerves and other important tissues to become a forbidden area for ablation, and the large blood vessels also affect the curative effect due to the "heat sedimentation" effect.

不可逆细胞电穿孔消融技术(Irreversible Electroporation,IRE)，又称纳米刀，是一种较新的消融技术。与其他消融方法比较，不仅能够实现对肿瘤细胞的灭活治疗，还具有微创、快捷、可控、可视、选择性和无热沉积的优势和特色，被逐渐应用于临床治疗中，对胰腺癌、肝癌、肾癌、***癌等肿瘤的治疗具有很好的效果。但是患者在电治疗过程中，往往会出现不同程度的肌肉收缩现象而导致其疼痛感和不适，而且纳米刀释放的高压脉冲对心电信号的产生和传导会产生极大的干扰，增大了引发心律失常等术中并发症的几率。Irreversible Electroporation (IRE), also known as Nanoknife, is a relatively new ablation technique. Compared with other ablation methods, it can not only achieve the inactivation of tumor cells, but also has the advantages and characteristics of minimally invasive, fast, controllable, visible, selective and no thermal deposition, and has been gradually applied in clinical treatment. The treatment of pancreatic cancer, liver cancer, kidney cancer, prostate cancer and other tumors has a very good effect. However, in the process of electrotherapy, patients often experience different degrees of muscle contraction, which leads to pain and discomfort, and the high-voltage pulses released by the nanoknife will greatly interfere with the generation and conduction of ECG signals. The risk of intraoperative complications such as arrhythmias.

技术问题technical problem

有鉴于此，本申请实施例提供了不可逆声穿孔设备、装置及计算机可读存储介质，以解决现有技术中进行消融时，容易使患者产生疼痛和不适，增大引发以待失常并发症的几率的问题。In view of this, the embodiments of the present application provide an irreversible acoustic perforation device, a device, and a computer-readable storage medium, so as to solve the problem that when ablation is performed in the prior art, it is easy to cause pain and discomfort to the patient, and increase the risk of complications to be caused. question of probability.

技术解决方案technical solutions

为解决上述技术问题，本申请实施例采用的技术方案是：In order to solve the above-mentioned technical problems, the technical solutions adopted in the embodiments of the present application are:

本申请实施例的第一方面提供了一种不可逆声穿孔设备，所述设备包括超声介入模块、超声电子激励模块、超声成像监控模块和控制模块，其中：A first aspect of the embodiments of the present application provides an irreversible acoustic perforation device, the device includes an ultrasound intervention module, an ultrasound electronic excitation module, an ultrasound imaging monitoring module, and a control module, wherein:

所述超声电子激励模块用于根据待消融的感兴趣区域的空间位置，确定生成超声波的激励信号；The ultrasonic electronic excitation module is used to determine the excitation signal for generating ultrasonic waves according to the spatial position of the region of interest to be ablated;

所述超声介入模块用于根据待消融的感兴趣区域进行目标组织的穿刺操作，并根据所述超声电子激励模块所生成的激励信号，发射可聚焦于所述感兴趣区域的超声波，使目标组织的感兴趣区域处的生物细胞的细胞膜上形成不可逆孔道，从而造成细胞凋亡，对所述目标组织的感兴趣区域进行消融；The ultrasonic intervention module is used to perform the puncture operation of the target tissue according to the region of interest to be ablated, and according to the excitation signal generated by the ultrasonic electronic excitation module, emit ultrasonic waves that can be focused on the region of interest, so that the target tissue can be punctured. irreversible pores are formed on the cell membrane of biological cells at the region of interest, thereby causing apoptosis, and ablating the region of interest in the target tissue;

所述超声监控成像模块用于接收所述超声介入模块所发射的超声波的回波信号，并根据所接收的回波信号生成和显示超声图像；The ultrasonic monitoring and imaging module is configured to receive the echo signal of the ultrasonic wave transmitted by the ultrasonic intervention module, and generate and display an ultrasonic image according to the received echo signal;

所述控制模块用于接收设置参数，并根据所述设置参数调整所述激励信号。The control module is used for receiving setting parameters and adjusting the excitation signal according to the setting parameters.

结合第一方面，在第一方面的第一种可能实现方式中，所述超声电子激励模块包括信号发送单元、功率放大单元和波束合成单元，其中：With reference to the first aspect, in a first possible implementation manner of the first aspect, the ultrasonic electronic excitation module includes a signal sending unit, a power amplifying unit and a beam forming unit, wherein:

所述波束合成单元用于根据所述超声图像中的感兴趣区域的空间位置，计算所述超声介入模块中的阵元的延迟时间；The beam forming unit is configured to calculate the delay time of the array elements in the ultrasound intervention module according to the spatial position of the region of interest in the ultrasound image;

所述信号发送单元用于根据超声介入模块中的阵元的延迟时间生成发送至各个阵元的信号；The signal sending unit is configured to generate a signal sent to each array element according to the delay time of the array element in the ultrasound intervention module;

所述功率放大单元用于对所述信号发送单元所发生的信号进行功率放大。The power amplifying unit is used for power amplifying the signal generated by the signal transmitting unit.

结合第一方面，在第一方面的第二种可能实现方式中，所述超声成像监控模块包括回波信号采集单元和图像重建单元，其中：With reference to the first aspect, in a second possible implementation manner of the first aspect, the ultrasonic imaging monitoring module includes an echo signal acquisition unit and an image reconstruction unit, wherein:

所述回波信号采集单元用于在所述超声介入模块发射超声波时，接收所发射的超声波对应的回波信号，提取所述回波信号中基波成分和非线性谐波成分；The echo signal acquisition unit is configured to receive the echo signal corresponding to the transmitted ultrasonic wave when the ultrasonic intervention module transmits the ultrasonic wave, and extract the fundamental wave component and the nonlinear harmonic component in the echo signal;

所述图像重建单元用于根据所述回波信号中的基波成分和非线性谐波成分变换，得到所述超声波对应的超声图像。The image reconstruction unit is configured to transform according to the fundamental wave component and the nonlinear harmonic component in the echo signal to obtain an ultrasound image corresponding to the ultrasound.

结合第一方面的第二种可能实现方式，在第一方面的第三种可能实现方式中，所述回波信号采集单元包括转换开关子单元、前置放大子单元、A/D采集子单元、时间增益补偿子单元、数字波束合成子单元、直流滤波子单元、I/Q解调子单元和带通滤波子单元，其中：With reference to the second possible implementation manner of the first aspect, in a third possible implementation manner of the first aspect, the echo signal acquisition unit includes a switch subunit, a preamplifier subunit, and an A/D acquisition subunit , time gain compensation subunit, digital beam forming subunit, DC filtering subunit, I/Q demodulation subunit and bandpass filtering subunit, wherein:

所述转换开关子单元用于在信号发射时，将信号模式在发射模式和接收模式之间转换；The transfer switch subunit is used to convert the signal mode between the transmitting mode and the receiving mode when the signal is transmitted;

所述前置放大子单元用于在信号模式处于接收模式时所接收的回波信号进行放大，通过所述A/D采集子单元采集得到数字信号；The preamplifier subunit is used for amplifying the echo signal received when the signal mode is in the receiving mode, and the digital signal is acquired by the A/D acquisition subunit;

所述时间增益补偿子单元用于对所采集的数字信号进行增益补偿；The time gain compensation subunit is used to perform gain compensation on the collected digital signal;

所述数字波束合成子单元用于根据不同空间点的延迟时间对增益补偿后的所述数字信号进行聚焦，得到波束合成后的回波信号；The digital beam forming subunit is used for focusing the digital signal after gain compensation according to the delay time of different spatial points, so as to obtain the echo signal after beam forming;

所述直流滤波子单元用于过滤所述波束合成后的回波信号中的直流分量，并通过所述I/Q解调子单元进行解调和带通滤波子单元的滤波处理，提取所述回波信号中的基波成分和 非线性谐波成分。The DC filtering subunit is used for filtering the DC component in the echo signal after the beam synthesis, and performs demodulation and filtering processing by the bandpass filtering subunit through the I/Q demodulation subunit, and extracts the Fundamental and nonlinear harmonic components in the echo signal.

结合第一方面的第二种可能实现方式，在第一方面的第四种可能实现方式中，所述图像重建单元包括包络提取子单元、压缩子单元、图像优化子单元和扫描变换子单元，其中：With reference to the second possible implementation manner of the first aspect, in a fourth possible implementation manner of the first aspect, the image reconstruction unit includes an envelope extraction subunit, a compression subunit, an image optimization subunit, and a scan conversion subunit ,in:

所述包络提取子单元用于根据基波成分和非线性谐波成分中的同相/正交分量，计算所述回波信号的幅度信息；The envelope extraction subunit is configured to calculate the amplitude information of the echo signal according to the in-phase/quadrature components in the fundamental component and the nonlinear harmonic component;

所述压缩子单元用于对所述幅度信息进行压缩，使数据压缩至适合显示的范围；The compression subunit is used for compressing the amplitude information, so that the data is compressed to a range suitable for display;

所述图像优化子单元用于对图像进行边缘增强和/或斑点噪声掏处理；The image optimization subunit is used to perform edge enhancement and/or speckle noise processing on the image;

所述扫描变换子单元用于通过坐标变换，对扫描的数据进行插值显示。The scan transformation subunit is used for interpolating and displaying the scanned data through coordinate transformation.

结合第一方面，在第一方面的第五种可能实现方式中，所述超声介入模块包括超声换能器单元和声结构单元，其中：With reference to the first aspect, in a fifth possible implementation manner of the first aspect, the ultrasound intervention module includes an ultrasound transducer unit and an acoustic structure unit, wherein:

所述超声换能器单元用于根据所述超声电子激励模块所产生的信号转换为超声波；The ultrasonic transducer unit is used for converting into ultrasonic waves according to the signal generated by the ultrasonic electronic excitation module;

所述声结构单元用于提高所转换后的超声波的声功率。The acoustic structural unit is used to increase the acoustic power of the converted ultrasonic waves.

结合第一方面的第五种可能实现方式，在第一方面的第六种可能实现方式中，所述超声换能器单元包括单阵元换能器以及线阵换能器，所述单阵元换能器设置在超声换能单元中的针管的前端，所述线阵换能器设置在所述超声换能器单元中的针管侧面的声窗处。With reference to the fifth possible implementation of the first aspect, in a sixth possible implementation of the first aspect, the ultrasonic transducer unit includes a single-array element transducer and a linear array transducer, and the single-array The primary transducer is arranged at the front end of the needle tube in the ultrasonic transducer unit, and the linear array transducer is arranged at the acoustic window on the side of the needle tube in the ultrasonic transducer unit.

结合第一方面，在第一方面的第七种可能实现方式中，所述控制模块包括焦点声压估测单元、空化效应计算单元、组织温升估计单元和激励参数优化单元，其中：With reference to the first aspect, in a seventh possible implementation manner of the first aspect, the control module includes a focus sound pressure estimation unit, a cavitation effect calculation unit, a tissue temperature rise estimation unit, and an excitation parameter optimization unit, wherein:

所述焦点声压估测单元用于根据焦点区域的形状对感兴趣区域进行填充，确定感兴趣区域内的焦点的位置分布，并根据焦点和各个阵元之间的距离，计算阵元发射信号的相位延迟，根据所述相位延迟计算声压场分布，根据所述声压场分布确定焦点声压；The focus sound pressure estimation unit is used to fill the area of interest according to the shape of the focus area, determine the position distribution of the focus in the area of interest, and calculate the transmission signal of the array element according to the distance between the focus and each array element the phase delay, calculate the sound pressure field distribution according to the phase delay, and determine the focus sound pressure according to the sound pressure field distribution;

所述空化效应计算单元用于根据所述焦点声压和微泡动力学议程，得到微泡的散射声压，并根据微泡空化引起的阈值剪切力确定焦点处的阈值声压，根据述微泡的散射声压和所述阈值声压，确定所述焦点处的空化效应信息；The cavitation effect calculation unit is used to obtain the scattered sound pressure of the microbubble according to the sound pressure of the focus and the dynamic agenda of the microbubble, and to determine the threshold sound pressure at the focus according to the threshold shear force caused by the cavitation of the microbubble, According to the scattered sound pressure of the microbubble and the threshold sound pressure, determine the cavitation effect information at the focal point;

所述组织温升估计单元用于根据所述声压场分布和预设的目标组织热扩散议程，得到所述目标组织随着时间变化的温度场分布；The tissue temperature rise estimation unit is configured to obtain the temperature field distribution of the target tissue over time according to the sound pressure field distribution and a preset thermal diffusion agenda of the target tissue;

所述激励参数优化单元用于根据所述组织温升估计单元和所述空化效应计算单元的结果，调整信号的激励参数。The excitation parameter optimization unit is configured to adjust the excitation parameter of the signal according to the results of the tissue temperature rise estimation unit and the cavitation effect calculation unit.

本申请实施例的第二方面提供了一种不可逆声穿孔装置，不可逆声穿孔装置，所述装置包括：A second aspect of the embodiments of the present application provides an irreversible acoustic perforation device, the irreversible acoustic perforation device, the device comprising:

激励信号确定单元，用于根据待消融的感兴趣区域的空间位置，确定阵元所对应的超声波的激励信号的延迟时间；an excitation signal determination unit, configured to determine the delay time of the excitation signal of the ultrasonic wave corresponding to the array element according to the spatial position of the region of interest to be ablated;

超声波发射单元，用于根据所确定的延迟时间发送激励所述阵元的信号，得到所述信号对应的、用于在所述感兴趣区域实现超声波聚焦的超声波，以根据所述聚焦的超声波在所述感兴趣区域产生空化效应；The ultrasonic transmitting unit is configured to send a signal to excite the array element according to the determined delay time, and obtain the ultrasonic wave corresponding to the signal and used to realize the ultrasonic focusing in the region of interest, so that according to the focused ultrasonic wave the region of interest produces a cavitation effect;

超声图像获取单元，用于采集所发射的超声波发射对应的回波信号，根据所述回波信号生成超声图像；an ultrasonic image acquisition unit, configured to collect echo signals corresponding to the transmitted ultrasonic waves, and generate an ultrasonic image according to the echo signals;

调整单元，用于接收用户根据所述超声图像输入的控制参数，根据所述控制参数调整所述超声波的激励信号。The adjusting unit is configured to receive the control parameters input by the user according to the ultrasonic image, and adjust the excitation signal of the ultrasonic wave according to the control parameters.

本申请实施例的第四方面提供了一种计算机可读存储介质，所述计算机可读存储介质存储有计算机程序，所述计算机程序包括第二方面所述装置中的单元。A fourth aspect of the embodiments of the present application provides a computer-readable storage medium, where the computer-readable storage medium stores a computer program, and the computer program includes the units in the apparatus of the second aspect.

有益效果beneficial effect

本申请实施例与现有技术相比存在的有益效果是：本申请实施例所述不可逆声穿孔设备，通过超声电子激励模块根据感兴趣区域的空间位置生成超声波的激励信号，所述超声介入模块根据所生成的激励信号转换为超声波，诱发目标组织内产生空化泡云，利用空化效应在目标组织的感兴趣区域的生物细胞的细胞膜处形成多个不可逆孔道，破坏细胞内外水平衡，引起细胞凋亡，从而对目标组织中的感兴趣区域进行消融，并通过监控成像模块所采集的回波信号显示超声图像，并可通过控制模块接收参数的设置和调整，可用于对超声激励***进行调整。由于本申请所述设备利用超声波在目标组织的感兴趣区域产生空化泡云，利用空化效应使生物细胞的细胞膜产生不可逆声穿孔，引起细胞凋亡，实现灭活癌细胞的目的可避免使用热效应所产生的热沉积问题，并且对周围组织损伤小，可以保留细胞基质和细胞周围的其它结构，包括如神经、大血管和胆管等结构的完整性，减少由电穿孔治疗的疼痛，避免因高压脉冲而产生并发症。通过控制模块可以根据超声影像对消融过程进行精准监测，有利于提高消融控制精度。The beneficial effects of the embodiments of the present application compared with the prior art are: the irreversible sonoporation device described in the embodiments of the present application generates an ultrasonic excitation signal according to the spatial position of the region of interest through the ultrasonic electronic excitation module, and the ultrasonic intervention module The generated excitation signal is converted into ultrasonic waves to induce cavitation bubble clouds in the target tissue, and the cavitation effect is used to form multiple irreversible pores in the cell membrane of biological cells in the region of interest in the target tissue, disrupting the water balance inside and outside the cells, causing Cell apoptosis, so as to ablate the region of interest in the target tissue, and display the ultrasonic image by monitoring the echo signal collected by the imaging module, and can receive the setting and adjustment of the parameters through the control module, which can be used for the ultrasonic excitation system. Adjustment. Since the device described in this application uses ultrasonic waves to generate cavitation bubble clouds in the region of interest of the target tissue, and uses the cavitation effect to cause irreversible acoustic perforation of the cell membrane of biological cells, causing cell apoptosis, the purpose of inactivating cancer cells can be avoided. The thermal deposition problem caused by the thermal effect and the small damage to the surrounding tissue can preserve the integrity of the cell matrix and other structures around the cell, including structures such as nerves, large blood vessels, and bile ducts, reduce pain treated by electroporation, and avoid Complications from high voltage pulses. The control module can accurately monitor the ablation process according to the ultrasound image, which is beneficial to improve the ablation control accuracy.

附图说明Description of drawings

为了更清楚地说明本申请实施例中的技术方案，下面将对实施例或示范性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它的附图。In order to illustrate the technical solutions in the embodiments of the present application more clearly, the following briefly introduces the accompanying drawings that are used in the description of the embodiments or exemplary technologies. Obviously, the drawings in the following description are only for the present application. In some embodiments, for those of ordinary skill in the art, other drawings can also be obtained according to these drawings without any creative effort.

图1是本申请实施例提供的不可逆声穿孔的实现原理示意图；Fig. 1 is the realization principle schematic diagram of the irreversible acoustic perforation provided by the embodiment of the present application;

图2是本申请实施例提供的一种可逆声穿孔设备的模块示意图；2 is a schematic diagram of a module of a reversible acoustic perforation device provided by an embodiment of the present application;

图3是本申请实施例提供的超声换能器结构示意图；3 is a schematic structural diagram of an ultrasonic transducer provided by an embodiment of the present application;

图4-图8是本申请实施例提供的不同阵元的发射相位延迟时间对应的超声波图像示意 图；4 to 8 are schematic diagrams of ultrasonic images corresponding to the transmission phase delay times of different array elements provided by the embodiments of the present application;

图9是本申请实施例提供的不可逆声穿孔装置的示意图；9 is a schematic diagram of an irreversible acoustic perforation device provided by an embodiment of the present application;

图10为本申请实施例提供的又一不可逆声穿孔装置的示意图。FIG. 10 is a schematic diagram of yet another irreversible acoustic perforation device provided by an embodiment of the present application.

本发明的实施方式Embodiments of the present invention

以下描述中，为了说明而不是为了限定，提出了诸如特定***结构、技术之类的具体细节，以便透彻理解本申请实施例。然而，本领域的技术人员应当清楚，在没有这些具体细节的其它实施例中也可以实现本申请。在其它情况中，省略对众所周知的***、装置、电路以及方法的详细说明，以免不必要的细节妨碍本申请的描述。In the following description, for the purpose of illustration rather than limitation, specific details such as a specific system structure and technology are set forth in order to provide a thorough understanding of the embodiments of the present application. However, it will be apparent to those skilled in the art that the present application may be practiced in other embodiments without these specific details. In other instances, detailed descriptions of well-known systems, devices, circuits, and methods are omitted so as not to obscure the description of the present application with unnecessary detail.

为了说明本申请所述的技术方案，下面通过具体实施例来进行说明。In order to illustrate the technical solutions described in the present application, the following specific embodiments are used for description.

目前的消融手术，通常采用的热消融方式，导致肿瘤靠近胃肠道、胆管、尿道、神经等重要组织时，热消融无法对这种部位的肿瘤进行消融处理。并且，由于大血管的热沉降效应，会影响到热消融的疗效。而不可逆细胞电穿孔消融技术与其它消融技术相比，不仅能够实现对肿瘤的灭活治疗，还具有微创、快捷、可控、可视、可选择性和无热沉积的优势，被逐渐应用于临床治疗中，对胰腺癌、肝癌、肾癌、***癌等肿瘤的治疗具有很好的效果。但是患者在电治疗过程往往会出现不同程度的肌肉收缩现象而导致其疼痛感和不适，而且纳米刀释放的高压脉冲对心电信号的产生和传导会产生极大的干扰，增大了引发心律失常等术中并发症的机率。The current ablation operation usually adopts the thermal ablation method. When the tumor is close to important tissues such as the gastrointestinal tract, bile duct, urethra, and nerve, thermal ablation cannot ablate the tumor in this part. In addition, due to the thermal deposition effect of large blood vessels, the efficacy of thermal ablation will be affected. Compared with other ablation techniques, irreversible cell electroporation ablation technology can not only achieve tumor inactivation treatment, but also has the advantages of minimally invasive, rapid, controllable, visual, selective and no thermal deposition, and has been gradually applied. In clinical treatment, it has a good effect on the treatment of pancreatic cancer, liver cancer, kidney cancer, prostate cancer and other tumors. However, patients often experience different degrees of muscle contraction during electrotherapy, which leads to pain and discomfort, and the high-voltage pulses released by the nanoknife will greatly interfere with the generation and conduction of ECG signals, increasing the risk of cardiac rhythm. The probability of intraoperative complications such as abnormalities.

基于上述问题，本申请提出了一种不可逆声穿孔设备，可以基于声波不可逆声穿孔效应实现肿瘤消融。如图1所示为本申请实施例提供的不可逆声穿孔的实现原理示意图，通过该设备，可以在生物组织的细胞上产生不可逆的孔道，引起细胞凋亡，从而消融生物组织。利用针式的超声换能器及声波引导结构，穿刺到生物组织内部，直接接触要消融的生物组织，采用高声压、短脉冲(比如可以为微秒级的短脉冲)，诱发声波引导结构周围的生物组织内产生空化泡云。利用空化效应使生物细胞的外膜形成不可逆的也孔道。破坏细胞内外的水平衡，从而造成细胞凋亡。同时，体内吞噬细胞将细胞碎片吞噬后，激活机体免疫反应，实现对肿瘤的灭活效果。基于空化效应的超声波消融方式，可以实现无热沉积的效果，对周围正常组织操伤小。Based on the above problems, the present application proposes an irreversible acoustic perforation device, which can realize tumor ablation based on the irreversible acoustic perforation effect of acoustic waves. Figure 1 shows a schematic diagram of the implementation principle of the irreversible acoustic perforation provided in the embodiment of the present application. With this device, irreversible pores can be generated in the cells of biological tissue, causing apoptosis, thereby ablating biological tissue. A needle-type ultrasonic transducer and a sound wave guiding structure are used to puncture into the biological tissue and directly contact the biological tissue to be ablated. High sound pressure and short pulses (such as short pulses in microseconds) are used to induce the sound wave guiding structure. A cloud of cavitation bubbles is created in the surrounding biological tissue. The cavitation effect is used to form irreversible pores in the outer membrane of biological cells. Disrupting the water balance inside and outside cells, resulting in apoptosis. At the same time, after phagocytizing the cell debris, the phagocytic cells in vivo activate the body's immune response to inactivate the tumor. The ultrasonic ablation method based on the cavitation effect can achieve the effect of no thermal deposition and cause little damage to the surrounding normal tissue.

图2为本申请实施例提供的一种不可逆声穿孔设备的模块示意图，如图2所示，所述不可逆声穿孔设备包括超声介入模块、超声电子激励模块、超声成像监控模块和控制模块，其中：FIG. 2 is a schematic block diagram of an irreversible acoustic perforation device provided in an embodiment of the application. As shown in FIG. 2 , the irreversible acoustic perforation device includes an ultrasound intervention module, an ultrasound electronic excitation module, an ultrasound imaging monitoring module, and a control module, wherein :

所述超声电子激励模块用于根据待消融的感兴趣区域的空间位置，确定生成超声波的激励信号；The ultrasonic electronic excitation module is used to determine the excitation signal for generating ultrasonic waves according to the spatial position of the region of interest to be ablated;

所述超声介入模块用于根据待消融的感兴趣区域进行目标组织的穿刺操作，并根据所述超声电子激励模块所生成的激励信号，发射可聚焦于所述感兴趣区域的超声波，在目标组织的感兴趣区域处的细胞膜形成不可逆孔道，对所述感兴趣区域进行消融；The ultrasonic intervention module is used to perform a puncture operation on the target tissue according to the region of interest to be ablated, and according to the excitation signal generated by the ultrasonic electronic excitation module, emit ultrasonic waves that can be focused on the region of interest, and transmit the ultrasonic waves in the target tissue. The cell membrane at the region of interest forms an irreversible pore, and the region of interest is ablated;

所述超声监控成像模块用于接收所述超声介入模块所发射的超声波的回波信号，并根据所接收的回波信号生成和显示超声图像；The ultrasonic monitoring and imaging module is configured to receive the echo signal of the ultrasonic wave transmitted by the ultrasonic intervention module, and generate and display an ultrasonic image according to the received echo signal;

所述控制模块用于接收设置参数，并根据所述设置参数调整所述激励信号。The control module is used for receiving setting parameters and adjusting the excitation signal according to the setting parameters.

其中，所述超声介入模块可以包括超声换能器单元和声结构单元。所述超声换能器单元用于产生超声波。声结构单元用于提高声功率。超声换能器单元为功率型换能器，用于发射功率聚焦超声，通过空化效应，引起肿瘤细胞的凋亡。Wherein, the ultrasonic intervention module may include an ultrasonic transducer unit and an acoustic structure unit. The ultrasonic transducer unit is used to generate ultrasonic waves. Acoustic structural units are used to increase the sound power. The ultrasonic transducer unit is a power type transducer, which is used for transmitting power focused ultrasonic waves to induce apoptosis of tumor cells through the cavitation effect.

为了达到微创的效果，考虑加工工艺的难度，如图3所示，超声换能器单元可以为针管结构。针管内径可以为1-2毫米，外径为1.5-2.5毫米。所述超声换能器单元包括单阵元换能器1和线阵换能器2，其中，单阵元换能器1设置在超声换能器单元中的针管的前端，比如图3位于穿刺针头3的位置，所述线阵换能器2设置在超声换能器单元的针管的侧面的声窗处。In order to achieve a minimally invasive effect, considering the difficulty of the processing technology, as shown in FIG. 3 , the ultrasonic transducer unit may be a needle tube structure. The inner diameter of the needle can be 1-2 mm and the outer diameter is 1.5-2.5 mm. The ultrasonic transducer unit includes a single-array element transducer 1 and a linear array transducer 2, wherein the single-array element transducer 1 is arranged at the front end of the needle tube in the ultrasonic transducer unit, for example, in Fig. The position of the needle 3, the linear array transducer 2 is arranged at the acoustic window on the side of the needle tube of the ultrasonic transducer unit.

在可能的实现方式中，线阵换能器中的可以包括多个阵元，比如图3中包括16个阵元。每个阵元的百度可以为2-2.5毫米，阵元间距可以为1-2毫米。激励所述阵元的中心频率可以为1MHz。In a possible implementation manner, the linear array transducer may include multiple array elements, for example, 16 array elements in FIG. 3 . The Baidu of each array element can be 2-2.5 mm, and the array element spacing can be 1-2 mm. The center frequency for exciting the array element may be 1 MHz.

所述超声电子激励模块用于产生可激励阵元发射超声波的信号。在可能的实现方式中，所述超声电子激励模块可以包括信号发送单元、功率放大单元和波束合成单元，其中：The ultrasonic electronic excitation module is used to generate a signal that can excite the array element to emit ultrasonic waves. In a possible implementation manner, the ultrasonic electronic excitation module may include a signal sending unit, a power amplifying unit and a beam forming unit, wherein:

所述波束合成单元用于根据所述超声图像中的感兴趣区域的空间位置，计算所述超声介入模块中的阵元的延迟时间。The beam forming unit is configured to calculate the delay time of the array elements in the ultrasound intervention module according to the spatial position of the region of interest in the ultrasound image.

所述信号发送单元用于根据超声介入模块中的阵元的延迟时间生成发送至各个阵元的信号；所述功率放大单元用于对所述信号发送单元所发生的信号进行功率放大。The signal sending unit is configured to generate a signal to be sent to each array element according to the delay time of the array elements in the ultrasound intervention module; the power amplifying unit is configured to power amplify the signal generated by the signal sending unit.

所述波束合成单元可以根据超声图像中感兴趣区域的空间位置，结合超声换能器的针管的位置，计算超声换能器中的每个阵元产生超声波的延迟时间。将将所计算的每个阵元的延迟时间发送至各个阵元所对应的信号发送单元。所述信号发送单元根据计算的延迟时间发送信号，经功率放大单元放大后，激励相应的阵元发射超声波，各阵元发射的超声波传播至感兴趣区域并聚焦。The beam forming unit can calculate the delay time for each array element in the ultrasonic transducer to generate ultrasonic waves according to the spatial position of the region of interest in the ultrasonic image and in combination with the position of the needle tube of the ultrasonic transducer. The calculated delay time of each array element is sent to the signal sending unit corresponding to each array element. The signal sending unit sends a signal according to the calculated delay time, and after being amplified by the power amplifying unit, the corresponding array element is excited to emit ultrasonic waves, and the ultrasonic waves emitted by each array element propagate to the region of interest and focus.

在可能的实现方式中，所述信号发送单元可由2台8通道的TEK(泰克)信号发生器AWG5208和一台AFG2000实现。功率放大单元可以通过17个功率放大器LZY-22X+实现。2台AWG5208为穿刺换能器中的线阵换能器提供16路发射信号，1台AFG2000为其单阵 元换能器提供1路发射信号。In a possible implementation, the signal sending unit can be realized by two 8-channel TEK signal generators AWG5208 and one AFG2000. The power amplification unit can be realized by 17 power amplifiers LZY-22X+. Two sets of AWG5208 provide 16 channels of transmit signals for the linear array transducer in the puncture transducer, and one set of AFG2000 provides one channel of transmit signals for its single-array element transducer.

在可能的实现方式中，所述超声成像监控模块包括回波信号采集单元和图像重建单元，其中：所述回波信号采集单元用于在所述超声介入模块发射超声波时，接收所发射的超声波对应的回波信号，提取所述回波信号中基波成分和非线性谐波成分；所述图像重建单元用于根据所述回波信号中的基波成分和非线性谐波成分变换，得到所述超声波对应的超声图像。In a possible implementation manner, the ultrasonic imaging monitoring module includes an echo signal acquisition unit and an image reconstruction unit, wherein: the echo signal acquisition unit is configured to receive the transmitted ultrasonic waves when the ultrasonic intervention module transmits ultrasonic waves The corresponding echo signal is extracted from the fundamental wave component and the nonlinear harmonic component in the echo signal; the image reconstruction unit is used for transforming the fundamental wave component and the nonlinear harmonic component in the echo signal to obtain The ultrasound image corresponding to the ultrasound.

如图2所示，所述回波信号采集单元可以包括转换开关子单元、前置放大子单元、A/D采集子单元、时间增益补偿子单元、数字波束合成子单元、直流滤波子单元、I/Q解调子单元和带通滤波子单元，其中：As shown in FIG. 2 , the echo signal acquisition unit may include a switch subunit, a preamplifier subunit, an A/D acquisition subunit, a time gain compensation subunit, a digital beam synthesis subunit, a DC filter subunit, I/Q demodulation subunit and bandpass filtering subunit, where:

所述转换开关子单元用于在信号发射时，将信号模式在发射模式和接收模式之间转换；所述前置放大子单元用于在信号模式处于接收模式时所接收的回波信号进行放大，通过所述A/D采集子单元采集得到数字信号；所述时间增益补偿子单元用于对所采集的数字信号进行增益补偿；所述数字波束合成子单元用于根据不同空间点的延迟时间对增益补偿后的所述数字信号进行聚焦，得到波束合成后的回波信号；所述直流滤波子单元用于过滤所述波束合成后的回波信号中的直流分量，并通过所述I/Q解调子单元进行解调和带通滤波子单元的滤波处理，提取所述回波信号中的基波成分和非线性谐波成分。The conversion switch subunit is used to convert the signal mode between the transmission mode and the reception mode when the signal is transmitted; the preamplifier subunit is used to amplify the echo signal received when the signal mode is in the reception mode , the digital signal is collected by the A/D collection subunit; the time gain compensation subunit is used to perform gain compensation on the collected digital signal; the digital beam synthesis subunit is used for delay time according to different spatial points Focusing the digital signal after gain compensation to obtain an echo signal after beam synthesis; the DC filter subunit is used to filter the DC component in the echo signal after beam synthesis, and pass the I/ The Q demodulation subunit performs the filtering processing of the demodulation and bandpass filtering subunits, and extracts the fundamental wave component and the nonlinear harmonic component in the echo signal.

波束合成单元根据感兴趣区域的空间位置聚焦所需要的延迟时间，确定信号发送单元发送信号的延迟时间。根据所述延迟时间将信号发送至对应的单阵元，激励产生超声波，在感兴趣的空间位置处形成聚焦。The beam synthesizing unit determines the delay time of the signal sent by the signal sending unit according to the delay time required for focusing on the spatial position of the region of interest. According to the delay time, the signal is sent to the corresponding unit array element, and the ultrasonic wave is excited and generated, and the focus is formed at the spatial position of interest.

在所述超声波的发射间期，可以通过转换开关子单元将阵元从发射模式转换为接收模式，在接收模式下，接收不同位置的回波信号。其中，所述转换开关子单元可以按照预定的转换频率进行接收模式和发射模式的转换。回波信号经过前置放大子单元放大后，经过A/D采集，将模拟信号转换为数字信号，并经过时间增益补偿子单元对衰减的信号进行补偿。数字波束合成子单元用于根据不同空间点的延迟时间对回波信号进行聚焦，波束合成后的回波信号，通过直流滤波子单元过滤其中的直流分量，并经过I/Q(同相/正交)解调子单元进行解调处理，以及通过带通滤波子单元进行滤波处理，从回波信号中提取出其中的基波成分和非线性谐波成分，以便于根据所提取的基波成分和非线性谐波成分进行成像计算。During the transmission period of the ultrasonic wave, the array element can be converted from the transmission mode to the reception mode through the switch subunit, and in the reception mode, echo signals at different positions are received. Wherein, the switch sub-unit can perform switching between the receiving mode and the transmitting mode according to a predetermined switching frequency. After the echo signal is amplified by the preamplifier subunit, it is collected by A/D, converts the analog signal into a digital signal, and compensates the attenuated signal through the time gain compensation subunit. The digital beamforming subunit is used to focus the echo signal according to the delay time of different spatial points. The echo signal after beamforming is filtered by the DC filtering subunit, and the DC component is filtered through the I/Q (in-phase/quadrature). ) The demodulation subunit performs demodulation processing, and performs filtering processing through the band-pass filtering subunit, and extracts the fundamental wave component and the nonlinear harmonic component from the echo signal, so as to facilitate the extraction of the fundamental wave component and the nonlinear harmonic component according to the extracted Nonlinear harmonic components for imaging calculations.

所述图像重建单元包括包络提取子单元、压缩子单元、图像优化子单元和扫描变换子单元，其中：The image reconstruction unit includes an envelope extraction subunit, a compression subunit, an image optimization subunit and a scan transformation subunit, wherein:

所述包络提取子单元用于根据基波成分和非线性谐波成分中的同相/正交分量，计算所 述回波信号的幅度信息；所述压缩子单元用于对所述幅度信息进行压缩，使数据压缩至适合显示的范围；所述图像优化子单元用于对图像进行边缘增强和/或斑点噪声掏处理；所述扫描变换子单元用于通过坐标变换，对扫描的数据进行插值显示。The envelope extraction subunit is used to calculate the amplitude information of the echo signal according to the in-phase/quadrature components in the fundamental wave component and the nonlinear harmonic component; the compression subunit is used to perform the amplitude information analysis. Compression to compress the data to a range suitable for display; the image optimization subunit is used to perform edge enhancement and/or speckle noise processing on the image; the scan conversion subunit is used to interpolate the scanned data through coordinate transformation show.

对于基波和非线性谐波的I/Q(同相/正交)分量计算回波幅度信息后，可以对所计算的数据进行压缩，比如可以通过对数压缩的方式进行压缩。使压缩后的数据适合显示的动态范围。进一步对图像进行优化处理时，可以包括对图像进行边缘增强处理，以及斑点噪声抑制处理等。通过扫描变换，可以将数据进行坐标变换，将数据所在的坐标系变换为显示器的显示坐标系。对扫描的数据可以进行插值后显示。After the echo amplitude information is calculated for the I/Q (in-phase/quadrature) components of the fundamental wave and nonlinear harmonics, the calculated data may be compressed, for example, by logarithmic compression. Fits the compressed data into the dynamic range of the display. When further optimizing the image, it may include edge enhancement processing, speckle noise suppression processing, etc. on the image. Through scan transformation, the data can be coordinate transformed, and the coordinate system where the data is located can be transformed into the display coordinate system of the display. The scanned data can be interpolated and displayed.

在可能的实现方式中，超声成像的发射、接收与采集中，信号发送单元可以通过高压脉冲发射芯片LM96550实现，转换开关子单元可以通过高压收发转换芯片LM96530实现。前置放大、A/D采样可以通过芯片AD9272实现，控制采集的时钟可以通过芯片AD951X实现，数字波束合成可以通过FPGA实现，I/Q解调可以通过芯片AD8339实现。带通滤波等信号处理可以通过后台软件处理完成。In a possible implementation manner, in the transmission, reception and acquisition of ultrasonic imaging, the signal transmission unit can be realized by the high-voltage pulse transmitting chip LM96550, and the switch sub-unit can be realized by the high-voltage transceiver chip LM96530. The pre-amplification and A/D sampling can be realized by the chip AD9272, the clock to control the acquisition can be realized by the chip AD951X, the digital beam forming can be realized by the FPGA, and the I/Q demodulation can be realized by the chip AD8339. Signal processing such as band-pass filtering can be done through background software processing.

在可能的实现方式中，所述控制模块可以包括焦点声压估测单元、空化效应计算单元、组织温升估计单元和激励参数优化单元，其中：In a possible implementation manner, the control module may include a focus sound pressure estimation unit, a cavitation effect calculation unit, a tissue temperature rise estimation unit, and an excitation parameter optimization unit, wherein:

所述焦点声压估测单元用于根据焦点区域的形状对感兴趣区域进行填充，确定感兴趣区域内的焦点的位置分布，并根据焦点和各个阵元之间的距离，计算阵元发射信号的相位延迟，根据所述相位延迟计算声压场分布，根据所述声压场分布确定焦点声压；The focus sound pressure estimation unit is used to fill the area of interest according to the shape of the focus area, determine the position distribution of the focus in the area of interest, and calculate the transmission signal of the array element according to the distance between the focus and each array element the phase delay, calculate the sound pressure field distribution according to the phase delay, and determine the focus sound pressure according to the sound pressure field distribution;

所述空化效应计算单元用于根据所述焦点声压和微泡动力学议程，得到微泡的散射声压，并根据微泡空化引起的阈值剪切力确定焦点处的阈值声压，根据述微泡的散射声压和所述阈值声压，确定所述焦点处的空化效应信息；The cavitation effect calculation unit is used to obtain the scattered sound pressure of the microbubble according to the sound pressure of the focus and the dynamic agenda of the microbubble, and to determine the threshold sound pressure at the focus according to the threshold shear force caused by the cavitation of the microbubble, According to the scattered sound pressure of the microbubble and the threshold sound pressure, determine the cavitation effect information at the focal point;

所述组织温升估计单元用于根据所述声压场分布和预设的目标组织热扩散议程，得到所述目标组织随着时间变化的温度场分布；The tissue temperature rise estimation unit is configured to obtain the temperature field distribution of the target tissue over time according to the sound pressure field distribution and a preset thermal diffusion agenda of the target tissue;

所述激励参数优化单元用于根据所述组织温升估计单元和所述空化效应计算单元的结果，调整信号的激励参数。The excitation parameter optimization unit is configured to adjust the excitation parameter of the signal according to the results of the tissue temperature rise estimation unit and the cavitation effect calculation unit.

其中，在确定焦点声压时，可以根据焦点区域的开卷对感兴趣区域进行填充，以设计感兴趣区域(或治疗区域)内焦点的位置分布。根据焦点的位置分布，以及各阵元之间的距离，通过惠更斯原理，可以计算各个阵元发射信号的相位延迟。将计算的相位延迟代入声波动方程，结合伪谱法即可计算声压场分布，根据声压场分布确定焦点声压。Wherein, when determining the focal sound pressure, the region of interest can be filled according to the unwinding of the focal region, so as to design the position distribution of the focal point in the region of interest (or treatment region). According to the position distribution of the focal point and the distance between each array element, the phase delay of the signal transmitted by each array element can be calculated by the Huygens principle. Substitute the calculated phase delay into the acoustic wave equation, and combine the pseudospectral method to calculate the sound pressure field distribution, and determine the focal sound pressure according to the sound pressure field distribution.

在对空化效应进行计算时，可以将焦点处的声压作为入射声压，代入微泡动力学方程，得到微泡振动的半径-时间曲线，根据该曲线得到微泡的散射声压。结合微泡空化引起的阈 值剪切力的大小所确定的焦点处的阈值声压，确定焦点处的空化效应的状态。When calculating the cavitation effect, the sound pressure at the focal point can be used as the incident sound pressure, and it can be substituted into the microbubble dynamic equation to obtain the radius-time curve of the microbubble vibration. According to the curve, the scattered sound pressure of the microbubble can be obtained. Combined with the threshold sound pressure at the focal point determined by the magnitude of the threshold shear force caused by microbubble cavitation, the state of the cavitation effect at the focal point is determined.

在确定组织温升时，可以将计算得到的声压场分布代入生物组织热扩散方程，得到生物组织随时间变化的温度场分布，从而估计超声的作用时间、声压大小等参数。When determining the tissue temperature rise, the calculated sound pressure field distribution can be substituted into the thermal diffusion equation of the biological tissue to obtain the temperature field distribution of the biological tissue over time, thereby estimating parameters such as the action time of the ultrasound and the sound pressure.

根据上述的不可逆声穿孔设备进行治疗的实现方式中，可以在成像模式下发射3.5MHz超声对感兴趣区域或治疗区域进行成像。通过控制模块可以在显示的图像上标出感兴趣区域。基于-6dB焦域形状对感兴趣区域进行填充，各焦域的中心位置即为设计焦点位置。依次激发线阵换能器中的各个阵元发射超声波，并利用成像换能器接收信号，以计算各阵元与设置的焦点位置之间的距离，并进一步计算所获得的各个阵元的发射信号的相位延迟。将所计算的相位延迟代入波动方程，结合伪谱法即可计算得到声压场分布。In the implementation manner of performing treatment according to the above-mentioned irreversible sonoporation device, the region of interest or the treatment region can be imaged by transmitting 3.5 MHz ultrasound in the imaging mode. The region of interest can be marked on the displayed image through the control module. The region of interest is filled based on the shape of the -6dB focal region, and the center position of each focal region is the design focus position. Each array element in the linear array transducer is excited in turn to emit ultrasonic waves, and the imaging transducer is used to receive the signal to calculate the distance between each array element and the set focus position, and further calculate the obtained emission of each array element Phase delay of the signal. Substitute the calculated phase delay into the wave equation, and combine the pseudospectral method to calculate the sound pressure field distribution.

针对小振幅声波在均匀分布的非衰减介质中的传播情况，经过k空间伪谱法变换的一阶波动方程组的离散表达形式可以为：For the propagation of small-amplitude acoustic waves in a uniformly distributed non-attenuating medium, the discrete expression of the first-order wave equations transformed by the k-space pseudospectral method can be:

其中：ρ ₀为待治疗区域的组织密度，u为声质点速度，Δt是时间步长，ξ表示空间中笛卡尔坐标系的各个方向，uξ表示ξ方向上的声质点速度。，

表示空间傅立叶变换，

表示空间傅立叶逆变换，k为k空间算子，其定义是κ＝sinc((c ₀kΔt)/2)，i为虚数单位，kξ表示ξ方向上的波数，Δξ表示ξ方向上的空间网格间距，u为声质点速度，uξ表示ξ方向上的声质点速度。ξ表示空间中笛卡尔坐标系的各个方向，为待治疗区域的组织密度，u为声质点速度，Δt是时间步长，ρξ表示ξ方向上的密度。 Where: ρ ₀ is the tissue density of the area to be treated, u is the acoustic particle velocity, Δt is the time step, ξ is the directions of the Cartesian coordinate system in space, and uξ is the acoustic particle velocity in the ξ direction. ,

represents the spatial Fourier transform,

Represents the space inverse Fourier transform, k is the k-space operator, which is defined as κ=sinc((c ₀ kΔt)/2), i is the imaginary unit, kξ represents the wave number in the ξ direction, and Δξ represents the space network in the ξ direction grid spacing, u is the sound particle velocity, uξ represents the sound particle velocity in the direction of ξ. ξ represents each direction of the Cartesian coordinate system in space, is the tissue density in the area to be treated, u is the acoustic particle velocity, Δt is the time step, and ρξ represents the density in the ξ direction.

通过求解上述方程组可得到声场分布。The sound field distribution can be obtained by solving the above equations.

而入射声波传播到达超声造影剂微泡位置处的声压为p _ac(t)，该声压激励微泡产生的非线性振动可通过Rayleigh-Plesset类型的方程(RP方程)进行描述 The sound pressure of the incident sound wave propagating to the position of the ultrasound contrast agent microbubble is p _ac (t). The nonlinear vibration generated by the sound pressure excited microbubbles can be described by the Rayleigh-Plesset type equation (RP equation).

其中，ρ _l为微泡周围介质密度，R表示微泡的瞬时半径，

表示微泡瞬时半径的一阶导数，

表示微泡瞬时半径的二阶导数，p _g0为泡内气压，k为多方气体指数，R _e为微泡的初始平衡半径，μ _L为微泡周围介质的粘度，μ _s为微泡外壳的剪切粘度，G _s为微泡外壳的剪切模量，d _se为微泡外壳的厚度，p _ac(t)表示入射声波传播到达超声造影剂微泡位置处的声压。 Among them, ρ _l is the density of the medium around the microbubble, R is the instantaneous radius of the microbubble,

represents the first derivative of the instantaneous radius of the microbubble,

Represents the second derivative of the instantaneous radius of the microbubble, p _g0 is the air pressure in the bubble, k is the polytropic gas index, _Re is the initial equilibrium radius of the microbubble, _μL is the viscosity of the medium around the microbubble, and _μs is the microbubble shell Shear viscosity, G _s is the shear modulus of the microbubble shell, _dse is the thickness of the microbubble shell, and p _ac (t) is the sound pressure at which the incident acoustic wave propagates to the location of the ultrasound contrast agent microbubble.

通过四阶-五步的龙格-库塔法求解上述方程可得到微泡瞬时半径-时间(R-t)曲线，并可进一步计算微泡的散射声压

(r为距离微泡中心的距离)，以及微泡对临近细胞的法向应力P _n＝(2πf) ²ρR ₀(εR ₀)，以及切向应力τ _AC≈2(μρ) ^1/2(πf) ^3/2(εR ₀)(|ε|＜＜1)。通过调整输入参数，使得焦域产生的切向应力超过细胞开孔的阈值剪切应力。其中，f为入射超声波的频率，ρ为介质密度，μ为介质的剪切粘度，R0为微泡初始半径，ε为预设常数。 The instantaneous radius-time (Rt) curve of the microbubble can be obtained by solving the above equation by the fourth-order-five-step Runge-Kutta method, and the scattered sound pressure of the microbubble can be further calculated.

(r is the distance from the center of the microbubble), and the normal stress of the microbubble to the adjacent cells P _n =(2πf) ² ρR ₀ (εR ₀ ), and the tangential stress τ _AC ≈2(μρ) ^1/2 ( πf) ^3/2 (εR ₀ ) (|ε|<<1). By adjusting the input parameters, the tangential stress generated by the focal domain exceeds the threshold shear stress of cell opening. Among them, f is the frequency of the incident ultrasonic wave, ρ is the density of the medium, μ is the shear viscosity of the medium, R0 is the initial radius of the microbubble, and ε is a preset constant.

所述控制模块的实现方式中，可以采用复杂可编程逻辑器件(ComplexProgrammable Logic Device，CPLD)EPM7128SLC84-15为***的控制核心，控制器在整个电子***的工作中主要实现以下功能：液晶显示***的控制和操作界面，设置***工作参数，如超声换能器工作频率，重复频率，占空比、强度、导入时间、输出功率的设置，输出相应脉宽和频率的超声波PWM脉冲等。In the implementation of the control module, a complex programmable logic device (CPLD) EPM7128SLC84-15 can be used as the control core of the system, and the controller mainly realizes the following functions in the work of the entire electronic system: Control and operation interface, set system working parameters, such as ultrasonic transducer operating frequency, repetition frequency, duty cycle, intensity, lead-in time, output power settings, output ultrasonic PWM pulses with corresponding pulse width and frequency, etc.

所述控制模块可以包括人机交互电路，人机界面模块是人与***进行交互的接口，可以通过液晶屏显示***的工作参数和状态，并以触摸屏来实现***工作参数的设置。本申请实施例可以采用开关稳压器提供各部件所需电压值。The control module may include a human-computer interaction circuit, and the human-computer interface module is an interface for interaction between humans and the system. The operating parameters and status of the system can be displayed on a liquid crystal screen, and the setting of the operating parameters of the system can be realized by a touch screen. In this embodiment of the present application, a switching regulator may be used to provide voltage values required by each component.

为了验证本申请实施例所述不可逆声穿孔设备的可行性和有效性，通过仿真超声换能器声场分布，通过调整阵元的发射相位的延迟时间，控制聚焦点的空间位置发生改变，当 聚焦的中心声压超过20MPa时，达到细胞穿孔阈值。如图4-图8为本申请实施例提供的不同阵元的发射相位的延迟时间所得到的超声波图像示意图。从图中可以看出，对不同的发射相位的延迟时间，聚焦点与超声换能单元的针管的距离也不同，从而可以实现对不同空间的感兴趣区域进行聚焦调节的要求。In order to verify the feasibility and effectiveness of the irreversible acoustic perforation device described in the embodiment of the present application, by simulating the sound field distribution of the ultrasonic transducer and adjusting the delay time of the emission phase of the array element, the spatial position of the focusing point is controlled to change. When the central sound pressure exceeds 20MPa, the cell perforation threshold is reached. FIG. 4-FIG. 8 are schematic diagrams of ultrasonic images obtained by the delay time of the emission phases of different array elements according to the embodiments of the present application. It can be seen from the figure that the distance between the focus point and the needle tube of the ultrasonic transducer unit is also different for the delay time of different emission phases, so that the requirements of focusing adjustment for the region of interest in different spaces can be achieved.

图9为本申请实施例提供的一种不可逆声穿孔装置的示意图，如图9所示，该装置包括：FIG. 9 is a schematic diagram of an irreversible acoustic perforation device provided by an embodiment of the present application. As shown in FIG. 9 , the device includes:

激励信号确定单元901，用于根据待消融的感兴趣区域的空间位置，确定阵元所对应的超声波的激励信号的延迟时间；The excitation signal determination unit 901 is configured to determine the delay time of the excitation signal of the ultrasonic wave corresponding to the array element according to the spatial position of the region of interest to be ablated;

超声波发射单元902，用于根据所确定的延迟时间发送激励所述阵元的信号，得到所述信号对应的、用于在所述感兴趣区域实现超声波聚焦的超声波，以根据所述聚焦的超声波在所述感兴趣区域产生空化效应；The ultrasonic transmitting unit 902 is configured to send a signal for exciting the array element according to the determined delay time, and obtain the ultrasonic wave corresponding to the signal and used to realize the ultrasonic focusing in the region of interest, so as to obtain the ultrasonic wave corresponding to the signal for realizing the ultrasonic focusing in the region of interest, so as to obtain the ultrasonic wave corresponding to the signal for realizing the ultrasonic focusing in the region of interest. generating a cavitation effect in the region of interest;

超声图像获取单元903，用于采集所发射的超声波发射对应的回波信号，根据所述回波信号生成超声图像；an ultrasonic image acquisition unit 903, configured to collect an echo signal corresponding to the transmitted ultrasonic emission, and generate an ultrasonic image according to the echo signal;

调整单元904，用于接收用户根据所述超声图像输入的控制参数，根据所述控制参数调整所述超声波的激励信号。The adjusting unit 904 is configured to receive control parameters input by the user according to the ultrasonic image, and adjust the excitation signal of the ultrasonic wave according to the control parameters.

图9所示的不可逆声穿孔装置，与图2所示的不可逆声穿孔设备对应。The irreversible acoustic perforation device shown in FIG. 9 corresponds to the irreversible acoustic perforation device shown in FIG. 2 .

图10是本申请一实施例提供的又一不可逆声穿孔装置的示意图。如图10所示，该实施例的不可逆声穿孔装置10包括：处理器100、存储器101以及存储在所述存储器101中并可在所述处理器100上运行的计算机程序102，例如不可逆声穿孔程序。所述处理器100执行所述计算机程序102时实现上述各个不可逆声穿孔方法实施例中的步骤。或者，所述处理器100执行所述计算机程序102时实现上述各装置实施例中各模块/单元的功能。FIG. 10 is a schematic diagram of yet another irreversible acoustic perforation device provided by an embodiment of the present application. As shown in FIG. 10 , the irreversible acoustic perforation device 10 of this embodiment includes: a processor 100, a memory 101, and a computer program 102 stored in the memory 101 and executable on the processor 100, such as an irreversible acoustic perforation program. When the processor 100 executes the computer program 102, the steps in each of the above-mentioned embodiments of the irreversible acoustic perforation method are implemented. Alternatively, when the processor 100 executes the computer program 102, the functions of the modules/units in the foregoing device embodiments are implemented.

示例性的，所述计算机程序102可以被分割成一个或多个模块/单元，所述一个或者多个模块/单元被存储在所述存储器101中，并由所述处理器100执行，以完成本申请。所述一个或多个模块/单元可以是能够完成特定功能的一系列计算机程序指令段，该指令段用于描述所述计算机程序102在所述不可逆声穿孔装置10中的执行过程。Exemplarily, the computer program 102 may be divided into one or more modules/units, and the one or more modules/units are stored in the memory 101 and executed by the processor 100 to complete the this application. The one or more modules/units may be a series of computer program instruction segments capable of accomplishing specific functions, and the instruction segments are used to describe the execution process of the computer program 102 in the irreversible acoustic perforation device 10 .

所述不可逆声穿孔装置可包括，但不仅限于，处理器100、存储器101。本领域技术人员可以理解，图10仅仅是不可逆声穿孔装置10的示例，并不构成对不可逆声穿孔装置10的限定，可以包括比图示更多或更少的部件，或者组合某些部件，或者不同的部件，例如所述不可逆声穿孔装置还可以包括输入输出设备、网络接入设备、总线等。The irreversible acoustic perforation device may include, but is not limited to, a processor 100 and a memory 101 . Those skilled in the art can understand that FIG. 10 is only an example of the irreversible acoustic perforation device 10, and does not constitute a limitation to the irreversible acoustic perforation device 10, and may include more or less components than those shown in the figure, or combine some components, Or different components, for example, the irreversible acoustic perforation device may further include input and output devices, network access devices, buses, and the like.

所称处理器100可以是中央处理单元(Central Processing Unit，CPU)，还可以是其他通用处理器、数字信号处理器(Digital Signal Processor，DSP)、专用集成电路(Application  Specific Integrated Circuit，ASIC)、现场可编程门阵列(Field-Programmable Gate Array，FPGA)或者其他可编程逻辑器件、分立门或者晶体管逻辑器件、分立硬件组件等。通用处理器可以是微处理器或者该处理器也可以是任何常规的处理器等。The so-called processor 100 may be a central processing unit (Central Processing Unit, CPU), or other general-purpose processors, digital signal processors (Digital Signal Processors, DSP), application specific integrated circuits (Application Specific Integrated Circuit, ASIC), Field-Programmable Gate Array (FPGA) or other programmable logic devices, discrete gate or transistor logic devices, discrete hardware components, etc. A general purpose processor may be a microprocessor or the processor may be any conventional processor or the like.

所述存储器101可以是所述不可逆声穿孔装置10的内部存储单元，例如不可逆声穿孔装置10的硬盘或内存。所述存储器101也可以是所述不可逆声穿孔装置10的外部存储设备，例如所述不可逆声穿孔装置10上配备的插接式硬盘，智能存储卡(Smart Media Card,SMC)，安全数字(Secure Digital,SD)卡，闪存卡(Flash Card)等。进一步地，所述存储器101还可以既包括所述不可逆声穿孔装置10的内部存储单元也包括外部存储设备。所述存储器101用于存储所述计算机程序以及所述不可逆声穿孔装置所需的其他程序和数据。所述存储器101还可以用于暂时地存储已经输出或者将要输出的数据。The memory 101 may be an internal storage unit of the irreversible acoustic perforation device 10 , such as a hard disk or a memory of the irreversible acoustic perforation device 10 . The memory 101 may also be an external storage device of the irreversible acoustic punching device 10, such as a pluggable hard disk, a smart memory card (Smart Media Card, SMC), a secure digital (Secure Digital) device equipped on the irreversible acoustic punching device 10. Digital, SD) card, flash memory card (Flash Card), etc. Further, the memory 101 may also include both an internal storage unit of the irreversible acoustic perforation device 10 and an external storage device. The memory 101 is used for storing the computer program and other programs and data required by the irreversible acoustic perforation device. The memory 101 can also be used to temporarily store data that has been output or will be output.

所属领域的技术人员可以清楚地了解到，为了描述的方便和简洁，仅以上述各功能单元、模块的划分进行举例说明，实际应用中，可以根据需要而将上述功能分配由不同的功能单元、模块完成，即将所述装置的内部结构划分成不同的功能单元或模块，以完成以上描述的全部或者部分功能。实施例中的各功能单元、模块可以集成在一个处理单元中，也可以是各个单元单独物理存在，也可以两个或两个以上单元集成在一个单元中，上述集成的单元既可以采用硬件的形式实现，也可以采用软件功能单元的形式实现。另外，各功能单元、模块的具体名称也只是为了便于相互区分，并不用于限制本申请的保护范围。上述***中单元、模块的具体工作过程，可以参考前述方法实施例中的对应过程，在此不再赘述。Those skilled in the art can clearly understand that, for the convenience and simplicity of description, only the division of the above-mentioned functional units and modules is used as an example. Module completion, that is, dividing the internal structure of the device into different functional units or modules to complete all or part of the functions described above. Each functional unit and module in the embodiment may be integrated in one processing unit, or each unit may exist physically alone, or two or more units may be integrated in one unit, and the above-mentioned integrated units may adopt hardware. It can also be realized in the form of software functional units. In addition, the specific names of the functional units and modules are only for the convenience of distinguishing from each other, and are not used to limit the protection scope of the present application. For the specific working processes of the units and modules in the above-mentioned system, reference may be made to the corresponding processes in the foregoing method embodiments, which will not be repeated here.

在上述实施例中，对各个实施例的描述都各有侧重，某个实施例中没有详述或记载的部分，可以参见其它实施例的相关描述。In the foregoing embodiments, the description of each embodiment has its own emphasis. For parts that are not described or described in detail in a certain embodiment, reference may be made to the relevant descriptions of other embodiments.

本领域普通技术人员可以意识到，结合本文中所公开的实施例描述的各示例的单元及算法步骤，能够以电子硬件、或者计算机软件和电子硬件的结合来实现。这些功能究竟以硬件还是软件方式来执行，取决于技术方案的特定应用和设计约束条件。专业技术人员可以对每个特定的应用来使用不同方法来实现所描述的功能，但是这种实现不应认为超出本申请的范围。Those of ordinary skill in the art can realize that the units and algorithm steps of each example described in conjunction with the embodiments disclosed herein can be implemented in electronic hardware, or a combination of computer software and electronic hardware. Whether these functions are performed in hardware or software depends on the specific application and design constraints of the technical solution. Skilled artisans may implement the described functionality using different methods for each particular application, but such implementations should not be considered beyond the scope of this application.

在本申请所提供的实施例中，应该理解到，所揭露的装置/终端设备和方法，可以通过其它的方式实现。例如，以上所描述的装置/终端设备实施例仅仅是示意性的，例如，所述模块或单元的划分，仅仅为一种逻辑功能划分，实际实现时可以有另外的划分方式，例如多个单元或组件可以结合或者可以集成到另一个***，或一些特征可以忽略，或不执行。另一点，所显示或讨论的相互之间的耦合或直接耦合或通讯连接可以是通过一些接口，装 置或单元的间接耦合或通讯连接，可以是电性，机械或其它的形式。In the embodiments provided in this application, it should be understood that the disclosed apparatus/terminal device and method may be implemented in other manners. For example, the apparatus/terminal device embodiments described above are only illustrative. For example, the division of the modules or units is only a logical function division. In actual implementation, there may be other division methods, such as multiple units. Or components may be combined or may be integrated into another system, or some features may be omitted, or not implemented. On the other hand, the shown or discussed mutual coupling or direct coupling or communication connection may be through some interfaces, indirect coupling or communication connection of devices or units, which may be in electrical, mechanical or other forms.

所述作为分离部件说明的单元可以是或者也可以不是物理上分开的，作为单元显示的部件可以是或者也可以不是物理单元，即可以位于一个地方，或者也可以分布到多个网络单元上。可以根据实际的需要选择其中的部分或者全部单元来实现本实施例方案的目的。The units described as separate components may or may not be physically separated, and components displayed as units may or may not be physical units, that is, may be located in one place, or may be distributed to multiple network units. Some or all of the units may be selected according to actual needs to achieve the purpose of the solution in this embodiment.

另外，在本申请各个实施例中的各功能单元可以集成在一个处理单元中，也可以是各个单元单独物理存在，也可以两个或两个以上单元集成在一个单元中。上述集成的单元既可以采用硬件的形式实现，也可以采用软件功能单元的形式实现。In addition, each functional unit in each embodiment of the present application may be integrated into one processing unit, or each unit may exist physically alone, or two or more units may be integrated into one unit. The above-mentioned integrated units may be implemented in the form of hardware, or may be implemented in the form of software functional units.

所述集成的模块/单元如果以软件功能单元的形式实现并作为独立的产品销售或使用时，可以存储在一个计算机可读取存储介质中。基于这样的理解，本申请实现上述实施例方法中的全部或部分流程，也可以通过计算机程序指令相关的硬件来完成，所述的计算机程序可存储于一计算机可读存储介质中，该计算机程序在被处理器执行时，可实现上述各个方法实施例的步骤。其中，所述计算机程序包括计算机程序代码，所述计算机程序代码可以为源代码形式、对象代码形式、可执行文件或某些中间形式等。所述计算机可读介质可以包括：能够携带所述计算机程序代码的任何实体或装置、记录介质、U盘、移动硬盘、磁碟、光盘、计算机存储器、只读存储器(ROM，Read-Only Memory)、随机存取存储器(RAM，Random Access Memory)、电载波信号、电信信号以及软件分发介质等。需要说明的是，所述计算机可读介质包含的内容可以根据司法管辖区内立法和专利实践的要求进行适当的增减，例如在某些司法管辖区，根据立法和专利实践，计算机可读介质不包括是电载波信号和电信信号。The integrated modules/units, if implemented in the form of software functional units and sold or used as independent products, may be stored in a computer-readable storage medium. Based on this understanding, all or part of the processes in the methods of the above embodiments can also be implemented by computer programs instructing related hardware, and the computer programs can be stored in a computer-readable storage medium. When executed by the processor, the steps of the above-mentioned various method embodiments may be implemented. Wherein, the computer program includes computer program code, and the computer program code may be in the form of source code, object code, executable file or some intermediate form, and the like. The computer-readable medium may include: any entity or device capable of carrying the computer program code, a recording medium, a U disk, a removable hard disk, a magnetic disk, an optical disk, a computer memory, a read-only memory (ROM, Read-Only Memory) , Random Access Memory (RAM, Random Access Memory), electric carrier signal, telecommunication signal and software distribution medium, etc. It should be noted that the content contained in the computer-readable media may be appropriately increased or decreased according to the requirements of legislation and patent practice in the jurisdiction, for example, in some jurisdictions, according to legislation and patent practice, the computer-readable media Excluded are electrical carrier signals and telecommunication signals.

以上所述实施例仅用以说明本申请的技术方案，而非对其限制；尽管参照前述实施例对本申请进行了详细的说明，本领域的普通技术人员应当理解：其依然可以对前述各实施例所记载的技术方案进行修改，或者对其中部分技术特征进行等同替换；而这些修改或者替换，并不使相应技术方案的本质脱离本申请各实施例技术方案的精神和范围，均应包含在本申请的保护范围之内。The above-mentioned embodiments are only used to illustrate the technical solutions of the present application, but not to limit them; although the present application has been described in detail with reference to the above-mentioned embodiments, those of ordinary skill in the art should understand that: it can still be used for the above-mentioned implementations. The technical solutions described in the examples are modified, or some technical features thereof are equivalently replaced; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the spirit and scope of the technical solutions in the embodiments of the application, and should be included in the within the scope of protection of this application.

Claims (10)

1. 一种不可逆声穿孔设备，其特征在于，所述设备包括超声介入模块、超声电子激励模块、超声成像监控模块和控制模块，其中：An irreversible acoustic perforation device, characterized in that the device comprises an ultrasonic intervention module, an ultrasonic electronic excitation module, an ultrasonic imaging monitoring module and a control module, wherein:

   所述超声电子激励模块用于根据待消融的感兴趣区域的空间位置，确定生成超声波的激励信号；The ultrasonic electronic excitation module is used to determine the excitation signal for generating ultrasonic waves according to the spatial position of the region of interest to be ablated;

   所述超声介入模块用于根据待消融的感兴趣区域进行目标组织的穿刺操作，并根据所述超声电子激励模块所生成的激励信号，发射可聚焦于所述感兴趣区域的超声波，使目标组织的感兴趣区域处的生物细胞的细胞膜上形成不可逆孔道，从而造成细胞凋亡，对所述目标组织的感兴趣区域进行消融；The ultrasonic intervention module is used to perform the puncture operation of the target tissue according to the region of interest to be ablated, and according to the excitation signal generated by the ultrasonic electronic excitation module, emit ultrasonic waves that can be focused on the region of interest, so that the target tissue can be punctured. irreversible pores are formed on the cell membrane of biological cells at the region of interest, thereby causing apoptosis, and ablating the region of interest in the target tissue;

   所述超声监控成像模块用于接收所述超声介入模块所发射的超声波的回波信号，并根据所接收的回波信号生成和显示超声图像；The ultrasonic monitoring and imaging module is configured to receive the echo signal of the ultrasonic wave transmitted by the ultrasonic intervention module, and generate and display an ultrasonic image according to the received echo signal;

   所述控制模块用于接收设置参数，并根据所述设置参数调整所述激励信号。The control module is used for receiving setting parameters and adjusting the excitation signal according to the setting parameters.
2. 根据权利要求1所述的设备，其特征在于，所述超声电子激励模块包括信号发送单元、功率放大单元和波束合成单元，其中：The device according to claim 1, wherein the ultrasonic electronic excitation module comprises a signal transmitting unit, a power amplifying unit and a beam combining unit, wherein:

   所述波束合成单元用于根据所述超声图像中的感兴趣区域的空间位置，计算所述超声介入模块中的阵元的延迟时间；The beam forming unit is configured to calculate the delay time of the array elements in the ultrasound intervention module according to the spatial position of the region of interest in the ultrasound image;

   所述信号发送单元用于根据超声介入模块中的阵元的延迟时间生成发送至各个阵元的信号；The signal sending unit is configured to generate a signal sent to each array element according to the delay time of the array element in the ultrasound intervention module;

   所述功率放大单元用于对所述信号发送单元所发生的信号进行功率放大。The power amplifying unit is used for power amplifying the signal generated by the signal transmitting unit.
3. 根据权利要求1所述的设备，其特征在于，所述超声成像监控模块包括回波信号采集单元和图像重建单元，其中：The device according to claim 1, wherein the ultrasonic imaging monitoring module comprises an echo signal acquisition unit and an image reconstruction unit, wherein:

   所述回波信号采集单元用于在所述超声介入模块发射超声波时，接收所发射的超声波对应的回波信号，提取所述回波信号中基波成分和非线性谐波成分；The echo signal acquisition unit is configured to receive the echo signal corresponding to the transmitted ultrasonic wave when the ultrasonic intervention module transmits the ultrasonic wave, and extract the fundamental wave component and the nonlinear harmonic component in the echo signal;

   所述图像重建单元用于根据所述回波信号中的基波成分和非线性谐波成分变换，得到所述超声波对应的超声图像。The image reconstruction unit is configured to transform according to the fundamental wave component and the nonlinear harmonic component in the echo signal to obtain an ultrasound image corresponding to the ultrasound.
4. 根据权利要求3所述的设备，其特征在于，所述回波信号采集单元包括转换开关子单元、前置放大子单元、A/D采集子单元、时间增益补偿子单元、数字波束合成子单元、 直流滤波子单元、I/Q解调子单元和带通滤波子单元，其中：The device according to claim 3, wherein the echo signal acquisition unit comprises a switch subunit, a preamplifier subunit, an A/D acquisition subunit, a time gain compensation subunit, and a digital beam synthesis subunit , DC filtering subunit, I/Q demodulation subunit and bandpass filtering subunit, wherein:

   所述转换开关子单元用于在信号发射时，将信号模式在发射模式和接收模式之间转换；The conversion switch subunit is used to convert the signal mode between the transmission mode and the reception mode when the signal is transmitted;

   所述前置放大子单元用于在信号模式处于接收模式时所接收的回波信号进行放大，通过所述A/D采集子单元采集得到数字信号；The preamplifier subunit is used for amplifying the echo signal received when the signal mode is in the receiving mode, and the digital signal is acquired by the A/D acquisition subunit;

   所述时间增益补偿子单元用于对所采集的数字信号进行增益补偿；The time gain compensation subunit is used to perform gain compensation on the collected digital signal;

   所述数字波束合成子单元用于根据不同空间点的延迟时间对增益补偿后的所述数字信号进行聚焦，得到波束合成后的回波信号；The digital beam synthesis sub-unit is used to focus the digital signal after gain compensation according to the delay time of different spatial points, to obtain the echo signal after beam synthesis;

   所述直流滤波子单元用于过滤所述波束合成后的回波信号中的直流分量，并通过所述I/Q解调子单元进行解调和带通滤波子单元的滤波处理，提取所述回波信号中的基波成分和非线性谐波成分。The DC filtering subunit is used to filter the DC component in the echo signal after the beam synthesis, and performs demodulation and filtering processing by the bandpass filtering subunit through the I/Q demodulation subunit, and extracts the Fundamental and nonlinear harmonic components in the echo signal.
5. 根据权利要求3所述的设备，其特征在于，所述图像重建单元包括包络提取子单元、压缩子单元、图像优化子单元和扫描变换子单元，其中：The device according to claim 3, wherein the image reconstruction unit comprises an envelope extraction subunit, a compression subunit, an image optimization subunit and a scan conversion subunit, wherein:

   所述包络提取子单元用于根据基波成分和非线性谐波成分中的同相/正交分量，计算所述回波信号的幅度信息；The envelope extraction subunit is configured to calculate the amplitude information of the echo signal according to the in-phase/quadrature components in the fundamental wave component and the nonlinear harmonic component;

   所述压缩子单元用于对所述幅度信息进行压缩，使数据压缩至适合显示的范围；The compression subunit is used for compressing the amplitude information, so that the data is compressed to a range suitable for display;

   所述图像优化子单元用于对图像进行边缘增强和/或斑点噪声掏处理；The image optimization subunit is used to perform edge enhancement and/or speckle noise processing on the image;

   所述扫描变换子单元用于通过坐标变换，对扫描的数据进行插值显示。The scan transformation subunit is used for interpolating and displaying the scanned data through coordinate transformation.
6. 根据权利要求1所述的设备，其特征在于，所述超声介入模块包括超声换能器单元和声结构单元，其中：The device according to claim 1, wherein the ultrasonic intervention module comprises an ultrasonic transducer unit and an acoustic structure unit, wherein:

   所述超声换能器单元用于根据所述超声电子激励模块所产生的信号转换为超声波；The ultrasonic transducer unit is used for converting into ultrasonic waves according to the signal generated by the ultrasonic electronic excitation module;

   所述声结构单元用于提高所转换后的超声波的声功率。The acoustic structural unit is used to increase the acoustic power of the converted ultrasonic waves.
7. 根据权利要求6所述的设备，其特征在于，所述超声换能器单元包括单阵元换能器以及线阵换能器，所述单阵元换能器设置在超声换能单元中的针管的前端，所述线阵换能器设置在所述超声换能器单元中的针管侧面的声窗处。The device according to claim 6, wherein the ultrasonic transducer unit comprises a single-array element transducer and a linear array transducer, and the single-array element transducer is provided in the ultrasonic transducer unit. At the front end of the needle tube, the linear array transducer is arranged at the acoustic window on the side of the needle tube in the ultrasonic transducer unit.
8. 根据权利要求1所述的设备，其特征在于，所述控制模块包括焦点声压估测单元、空化效应计算单元、组织温升估计单元和激励参数优化单元，其中：The device according to claim 1, wherein the control module comprises a focus sound pressure estimation unit, a cavitation effect calculation unit, a tissue temperature rise estimation unit and an excitation parameter optimization unit, wherein:

   所述焦点声压估测单元用于根据焦点区域的形状对感兴趣区域进行填充，确定感兴趣 区域内的焦点的位置分布，并根据焦点和各个阵元之间的距离，计算阵元发射信号的相位延迟，根据所述相位延迟计算声压场分布，根据所述声压场分布确定焦点声压；The focus sound pressure estimation unit is used to fill the area of interest according to the shape of the focus area, determine the position distribution of the focus in the area of interest, and calculate the transmission signal of the array element according to the distance between the focus and each array element the phase delay, calculate the sound pressure field distribution according to the phase delay, and determine the focus sound pressure according to the sound pressure field distribution;

   所述空化效应计算单元用于根据所述焦点声压和微泡动力学议程，得到微泡的散射声压，并根据微泡空化引起的阈值剪切力确定焦点处的阈值声压，根据述微泡的散射声压和所述阈值声压，确定所述焦点处的空化效应信息；The cavitation effect calculation unit is used to obtain the scattered sound pressure of the microbubble according to the sound pressure of the focus and the dynamic agenda of the microbubble, and to determine the threshold sound pressure at the focus according to the threshold shear force caused by the cavitation of the microbubble, According to the scattered sound pressure of the microbubble and the threshold sound pressure, determine the cavitation effect information at the focal point;

   所述组织温升估计单元用于根据所述声压场分布和预设的目标组织热扩散议程，得到所述目标组织随着时间变化的温度场分布；The tissue temperature rise estimation unit is configured to obtain the temperature field distribution of the target tissue over time according to the sound pressure field distribution and a preset thermal diffusion agenda of the target tissue;

   所述激励参数优化单元用于根据所述组织温升估计单元和所述空化效应计算单元的结果，调整信号的激励参数。The excitation parameter optimization unit is configured to adjust the excitation parameter of the signal according to the results of the tissue temperature rise estimation unit and the cavitation effect calculation unit.
9. 一种不可逆声穿孔装置，其特征在于，所述装置包括：An irreversible acoustic perforation device, characterized in that the device comprises:

   激励信号确定单元，用于根据待消融的感兴趣区域的空间位置，确定阵元所对应的超声波的激励信号的延迟时间；an excitation signal determination unit, configured to determine the delay time of the excitation signal of the ultrasonic wave corresponding to the array element according to the spatial position of the region of interest to be ablated;

   超声波发射单元，用于根据所确定的延迟时间发送激励所述阵元的信号，得到所述信号对应的、用于在所述感兴趣区域实现超声波聚焦的超声波，以根据所述聚焦的超声波在所述感兴趣区域产生空化效应；The ultrasonic transmitting unit is configured to send a signal for exciting the array element according to the determined delay time, and obtain the ultrasonic wave corresponding to the signal and used to realize the ultrasonic focusing in the region of interest, so that the focused ultrasonic wave can be the region of interest produces a cavitation effect;

   超声图像获取单元，用于采集所发射的超声波发射对应的回波信号，根据所述回波信号生成超声图像；an ultrasonic image acquisition unit, configured to collect an echo signal corresponding to the transmitted ultrasonic wave emission, and generate an ultrasonic image according to the echo signal;

   调整单元，用于接收用户根据所述超声图像输入的控制参数，根据所述控制参数调整所述超声波的激励信号。The adjustment unit is configured to receive the control parameters input by the user according to the ultrasonic image, and adjust the excitation signal of the ultrasonic wave according to the control parameters.
10. 一种计算机可读存储介质，所述计算机可读存储介质存储有计算机程序，其特征在于，所述计算机程序包括权利要求9所述装置中的单元。A computer-readable storage medium storing a computer program, characterized in that, the computer program includes the unit in the apparatus of claim 9 .

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