WO2023284390A1 - 一种超声医疗设备 - Google Patents

一种超声医疗设备 Download PDF

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Publication number
WO2023284390A1
WO2023284390A1 PCT/CN2022/092103 CN2022092103W WO2023284390A1 WO 2023284390 A1 WO2023284390 A1 WO 2023284390A1 CN 2022092103 W CN2022092103 W CN 2022092103W WO 2023284390 A1 WO2023284390 A1 WO 2023284390A1
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sound wave
treatment
focal area
focused
feature information
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PCT/CN2022/092103
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English (en)
French (fr)
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龚晓波
宇景斌
尤开军
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重庆融海超声医学工程研究中心有限公司
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Publication of WO2023284390A1 publication Critical patent/WO2023284390A1/zh

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00Ultrasound therapy
    • A61N7/02Localised ultrasound hyperthermia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0833Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures

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  • the present invention relates to the field of ultrasonic medical equipment, in particular to an ultrasonic medical equipment.
  • High Intensity Focused Ultrasound (HIFU) surgery is a non-invasive treatment method, which uses the focusability and penetrability of ultrasound to focus on a specific position after passing through the human body, making the temperature of the focus area rise. High coagulation necrosis occurs, so as to achieve the purpose of treatment.
  • image monitoring has led to the development and application of this technology in clinical practice.
  • imaging tools are generally needed to monitor the effect of HIFU treatment on tissue destruction, so as to determine the effectiveness and safety of treatment.
  • imaging tools are mainly realized by magnetic resonance imaging and B-scan ultrasound (B-scan ultrasonography) imaging technology.
  • B-scan ultrasound B-scan ultrasonography
  • the price of magnetic resonance imaging equipment is relatively expensive, and the time for each scan is too long, which easily delays the treatment process of HIFU treatment.
  • B-ultrasound can meet the needs of HIFU treatment for image monitoring, and high-intensity focused ultrasound equipment guided by B-ultrasound has multiple advantages such as good real-time performance and low price.
  • the present invention aims to provide an ultrasonic medical device capable of improving the efficiency and safety of HIFU treatment.
  • the present invention provides an ultrasonic medical device, which is used to emit therapeutic sound waves to the focal area inside the tissue in each treatment round, so as to ablate the tissue in the focal area
  • the ultrasonic medical device includes a control device and a first sound wave transceiver assembly
  • the control device is used to control the first sound wave transceiver assembly to transmit focused detection sound waves to the focal area and receive the focal area during the gap between the treatment rounds
  • the control device is also used to extract characteristic information of the response sound wave, and generate focal area state prompt information according to the characteristic information.
  • the ultrasonic medical equipment further includes a B-ultrasound probe and a display device
  • the control device is also used to obtain the B-ultrasound image of the focal area through the B-ultrasound probe, and control the display device to display the B-ultrasound image and the prompt information of the focal area state.
  • the first sound wave transceiving component includes a first focused ultrasonic transducer
  • the response sound wave includes a reflected sound wave or a scattered sound wave generated by reflection or scattering of the detection sound wave in the focal area
  • the control device It is used to control the first focused ultrasonic transducer to emit focused detection sound waves to the focal area, and receive the reflected sound waves or the scattered sound waves.
  • the first sound wave transceiving component includes a first focused ultrasonic transducer and a receiving sensor
  • the response sound wave includes a reflected sound wave or a scattered sound wave generated by reflection or scattering of the detection sound wave in the focal area
  • the control device is used to control the first focused ultrasound transducer to transmit focused detection sound waves to the focal area, and control the receiving sensor to receive the reflected sound waves or the scattered sound waves.
  • the receiving sensor includes a second focused ultrasound transducer, and a focus of the second focused ultrasound transducer coincides with the focus area.
  • the receiving sensor is the B-ultrasound probe.
  • control device is also used to control the operation of the first sound wave transceiving component before the start of the first treatment round, extract the characteristic information of the response sound wave as the reference characteristic information, and The extracted feature information is compared with the reference feature information to obtain a feature information difference; the focal area state prompt information includes the value of the feature information difference.
  • the detection sound wave includes a plurality of pulse signals
  • the control device is specifically configured to extract multiple times of feature information from the multiple pulse signals in the response sound wave, and extract the feature information of the multiple times extracted The average value is compared with the reference feature information to obtain the feature information difference.
  • control device is further configured to determine a difference threshold according to the current treatment depth, and the prompt information of the focal region state further includes the current difference threshold.
  • control device is also used to control the first focused ultrasound transducer to emit the treatment sound waves in each treatment round.
  • the control device can control the first sound wave transceiver component to perform sound wave detection in the gap between treatment rounds, so as to obtain the characteristic information of the response sound wave generated by the tissue in the focal region, thereby generating real-time information related to the characteristic sound wave.
  • the prompt information of the focal zone state corresponding to the information.
  • Fig. 1 is a flowchart of the functions performed by the control device in the ultrasonic medical equipment provided by the embodiment of the present invention
  • Fig. 2 is a flow chart of the functions performed by the control device in the ultrasonic medical equipment provided by another embodiment of the present invention.
  • Fig. 3 is a flowchart of the functions performed by the control device in the ultrasonic medical equipment provided by another embodiment of the present invention.
  • Fig. 4 is a schematic diagram of a screen displayed by a display device in an ultrasonic medical device according to an embodiment of the present invention.
  • the inventor of the present invention found in the process of carrying out experimental research on HIFU treatment equipment that during the working process of HIFU treatment equipment, a kind of foggy artifact sometimes appears in the monitoring image of B-ultrasound, which affects the quality of the image. The process will undoubtedly increase the probability of misdiagnosis. And this foggy artifact only exists in the B-ultrasound-guided HIFU system, and does not exist in the traditionally used ultrasonic diagnostic images.
  • the experimental results obtained after the inventor adjusted the position of the B-ultrasound probe several times showed that the multiple reflections and refractions of the sound waves at this distance may be the cause of the fog artifact.
  • the present invention provides an ultrasonic medical device, which is used to emit therapeutic sound waves to the focal area (focal area) inside the tissue in each treatment round, so as to ablate the tissue in the focal area.
  • Ultrasonic medical equipment includes a control device and a first sound wave transceiver assembly, the control device is used to control the first sound wave transceiver assembly to emit focused detection sound waves to the focal area during the gap between treatment rounds, and receive the tissue response of the focal area It is used to detect the response sound wave generated by the sound wave (for example, the reflection sound wave generated by the reflection of the sound wave in the focal area or the scattered sound wave generated by scattering); the control device is also used to extract the characteristic information of the response sound wave, and generate the focal area state prompt information according to the characteristic information.
  • the control device is used to control the first sound wave transceiver assembly to emit focused detection sound waves to the focal area during the gap between treatment rounds, and to receive the response sound waves (reflected sound waves) produced by the tissue in the focal area.
  • Acoustic waves or scattered sound waves as the tissue in the focal area is ablated under the action of ultrasound, the acoustic impedance of the tissue in the focal area also changes, so that the characteristic information of the response to the acoustic wave changes, and then the characteristic information can reflect the tissue in the focal region.
  • Status degree of ablation
  • the control device controls the first sound wave transceiver assembly to perform sound wave detection in the interval between treatment rounds, so as to obtain the characteristic information of the response sound wave generated by the focal region tissue, so as to generate the focal region state prompt information corresponding to the characteristic information in real time.
  • medical personnel can comprehensively judge the tissue state of the focal area in combination with the prompt information of the focal area state, and then control the progress of treatment according to the prompt information of the focal area state when foggy artifacts appear in the B-ultrasound image.
  • additional operations such as adjusting the position of the B-ultrasound probe are frequently performed, which improves the treatment efficiency of HIFU ultrasound medical equipment and the safety of the treatment process.
  • the embodiment of the present invention does not specifically limit the characteristic information of the acoustic wave, as long as the characteristic information can change with the change of the ablation state of the focal region tissue, the characteristic information can be used to reflect the state of the focal region tissue, for example, optionally, the The characteristic information can include the phase of the sound wave (the propagation speed of the sound wave in the tissue changes with the degree of tissue ablation), the amplitude, and the energy (proportional to the integral of the sound wave amplitude in time, the attenuation degree of the sound wave energy and amplitude changes with the degree of tissue ablation), and so on.
  • the embodiment of the present invention does not specifically limit the form of the focal area state prompt information generated by the control device according to the feature information, as long as it can be intuitively and clearly displayed to the medical staff and reminded of the tissue ablation progress, for example, optionally, the focal area
  • the status prompt information can exist in various forms such as numbers, images, sound prompts, and vibration reminders of wearable devices.
  • the ultrasonic medical equipment also includes a B-ultrasound probe and a display device, and the control device is also used for The B-ultrasound image of the focus area is acquired by the B-ultrasound probe, and the display device is controlled to display the B-ultrasound image and the prompt information of the focal region state.
  • both the focal region B-ultrasound image and the focal region state prompt information are displayed on the screen of the display device, so that when foggy artifacts appear in the B-ultrasound image, the medical staff can directly browse the information displayed on the same display device. After the fog artifact in the B-ultrasound image disappears, you can seamlessly switch to the B-ultrasound image to browse the complete image information of the focal area tissue, thereby improving the operating efficiency of medical staff.
  • the HIFU treatment equipment can automatically determine the treatment depth through the coordinate position of the transducer) and the same type of tissue (such as the same organ, muscle tissue, connective tissue) respond
  • the response sound waves generated by the same detection sound wave are basically the same, and the change amount of the characteristic information of the tissue response sound wave from the beginning of the ablation to the end of the ablation is basically the same. Therefore, the degree of tissue ablation can be expressed by the change amount of the response sound wave characteristic information.
  • the control device is also used to control the operation of the first acoustic wave transceiver assembly before the first treatment round begins. (i.e. execute step S1), extract the characteristic information of the response sound wave as the reference characteristic information, and compare the extracted characteristic information with the reference characteristic information after each treatment round to obtain the characteristic information difference (i.e. execute step S3);
  • the prompt information includes the numerical value of the characteristic information difference.
  • the prompt information of the focal region state includes the value of the difference value of the characteristic information, so that during the HIFU treatment, the medical staff can The degree of tissue ablation in the focal region can be visually judged according to the numerical value of the characteristic information difference, thereby improving the convenience for medical staff to judge the tissue state in the focal region according to the characteristic information.
  • the detection sound wave includes multiple pulse signals sent in the same gap (that is, between two adjacent treatment rounds), and the control device is specifically used to Multiple feature information is extracted from multiple pulse signals in the response sound wave, and the average value of the feature information extracted multiple times is compared with the reference feature information to obtain a feature information difference.
  • the embodiment of the present invention does not specifically limit the number of pulse signals included in the detection sound wave, as long as it does not affect the normal treatment process.
  • the detection sound wave can be a single pulse, double pulse, triple pulse, or include more than three pulse signals .
  • the response sound wave will also include a corresponding number of pulse signals, and the control device extracts a plurality of characteristic information according to the plurality of pulse signals in the response sound wave, and compares the average value of the plurality of characteristic information with the reference characteristic information to obtain the characteristic information difference, Therefore, the accuracy of the characteristic information is improved, and the reliability of the prompt information of the focal region state is further improved.
  • control device can also analyze and obtain other information according to the feature information extracted multiple times corresponding to the multiple pulse signals in the response sound wave, as additional content in the focal region state prompt information, for example , optionally, the control device is further configured to determine the mean square error of the multiple extracted feature information corresponding to the multiple pulse signals in the response sound wave.
  • control device is further configured to determine the difference threshold according to the current treatment depth, and the prompt information of the focal area state further includes the current difference threshold.
  • the prompt information of the focal domain state also includes a difference threshold corresponding to the current treatment depth, so that the medical staff can pass the focal region at the same time after fog artifacts appear in the B-ultrasound image.
  • the domain state prompt information determines the characteristic information difference and the difference threshold, so as to intuitively understand whether the characteristic information difference has reached the difference threshold, thereby improving the convenience for medical staff to judge the tissue state of the focal region according to the characteristic information, and the effectiveness of HIFU treatment. safety.
  • the control device controls the focal area displayed by the display device
  • the status prompt information includes a histogram corresponding to the characteristic information difference and the difference threshold, and the two histograms are arranged side by side.
  • the histogram corresponding to the characteristic information difference and the difference threshold is located on one side of the B-ultrasound image, and the heights of the two histograms are respectively corresponding to the two corresponding heights.
  • the values are proportional to size. Therefore, in the process of HIFU treatment for any depth of tissue, the height of the histogram corresponding to the difference threshold remains unchanged, while the height of the histogram corresponding to the difference of feature information will gradually approach the height of the histogram of the difference threshold with multiple updates , when the two heights are equal, it means that the tissue in the focal area has been ablated.
  • the medical staff does not need to carefully read the value of the characteristic information difference and the value of the difference threshold, just browse the image The organization of the focal area can be quickly confirmed.
  • the characteristic information difference can also be displayed directly in the image of the display device in the form of a waveform diagram.
  • the difference threshold can be expressed as the upper and lower two
  • the waveform pattern corresponding to the characteristic information difference exceeds the range defined by the upper and lower baselines, it can be determined that the characteristic information difference has exceeded the difference threshold.
  • the focal area status prompt information can also include text description information, For example, the numerical value corresponding to the characteristic information difference and the difference threshold (that is, "xxx" at the top of the columnar pattern in Figure 4), the variance of multiple characteristic information differences acquired through multi-pulse, and so on.
  • control device is also used to execute step S4 and control the ultrasonic medical equipment when the characteristic information exceeds the difference threshold. Stop emitting therapeutic sound waves, or issue warning prompt information (for example, control the buzzer to sound a sound prompt, control the display device to pop up an alarm prompt, control the display device screen to flicker, control the wearable device to send out a vibration reminder, etc.).
  • the embodiment of the present invention does not specifically limit how to determine the difference threshold corresponding to each treatment depth, for example, the difference threshold may be obtained by analyzing actual treatment data.
  • the control device has the function of automatically recording and analyzing the difference threshold, specifically, as shown in Figure 3 It shows that the control device can perform tissue ablation (that is, perform step S02, perform high-intensity focused ultrasound treatment (HIFU treatment)), and there is no fog artifact in the B-ultrasound image (whether there is fog artifact can be determined by the machine according to the screen gray
  • the first sound wave transceiver component is automatically controlled to emit detection sound waves and receive response sound waves during non-treatment time, and when tissue ablation in the focal region (can be judged by the machine based on the gray scale of the screen) , can also be judged manually), record the total variation of the characteristic information of the response sound wave as the difference threshold corresponding to the current treatment depth (that is, execute step S04).
  • the control device can automatically judge the whole process. Specifically, at the first treatment depth, and (the control device judges according to the picture) no foggy artifacts appear in the B-ultrasound image, perform HIFU treatment until the control device judges that the tissue has been ablated according to the grayscale change in the B-ultrasound image , at this time, the total change of the echo feature information is K, and the difference threshold information corresponding to the first treatment depth is K.
  • HIFU treatment is performed until the control device judges that the tissue has been ablated according to the grayscale change in the B-ultrasound image.
  • the echo characteristic information The total change of is L, and the difference threshold information corresponding to the second treatment depth is L.
  • the first sound wave transceiver assembly includes a focused ultrasonic transducer that has both the functions of transmitting and detecting sound waves and receiving response sound waves.
  • the response sound waves can be reflected sound waves
  • the first sound wave transceiver assembly includes a first focused ultrasonic transducer
  • the response to the sound wave includes detecting reflected or scattered sound waves generated by reflection or scattering of the sound wave in the focal area
  • the control device is used to control the first focused ultrasonic transducer to the focal area A focused detection sound wave is transmitted and the reflected or scattered sound wave is received.
  • the detection sound waves can be transmitted to the focal area only through the focused ultrasonic transducer, and the response sound waves can be received by other devices.
  • the first sound wave transceiver component includes a first focused ultrasonic transducer and a receiving The sensor responds to the sound wave including detecting the reflected sound wave or scattered sound wave generated by the reflection or scattering of the sound wave in the focal area, and the control device is used to control the first focused ultrasonic transducer to transmit the focused detection sound wave to the focal area, and control the receiving sensor to receive the reflected sound wave or scattered sound waves.
  • the receiving sensor may be an ultrasonic transducer.
  • the receiving sensor is an ultrasonic transducer, in order to improve the signal stability of receiving reflected sound waves or scattered sound waves, preferably, the receiving sensor includes a second focused ultrasonic transducer, and the focus of the second focused ultrasonic transducer and the focus area coincide.
  • the receiving sensor can also be the aforementioned B-ultrasound probe for obtaining the focal region B-ultrasound image (acquisition of the frequency and amplitude of the sound wave of the B-ultrasound image and the detection of the sound wave There is a difference between the information and other information, so as to distinguish the various sound wave information received by the B-ultrasound probe).
  • the B-ultrasound probe can be installed in the center of the treatment transducer (that is, the transducer used to focus ultrasonic waves to the focal region tissue) Location.
  • the ultrasonic medical device does not specifically limit how the ultrasonic medical device emits therapeutic sound waves to the focal area.
  • the ultrasonic medical device may also include a second acoustic wave transceiver component for emitting focused therapeutic sound waves to the focal area during treatment time. .
  • the control device is also used to control the first focused ultrasound transducer to emit therapeutic sound waves in each treatment round. That is, in the embodiment of the present invention, the first focused ultrasound transducer not only has the function of emitting detection sound waves and detecting the tissue state in the focal region, but also can emit focused therapeutic sound waves to the tissue in the focal region during the treatment time, so that through the same focusing
  • the ultrasonic transducer realizes the functions of treatment and detection, which further simplifies the structure of the equipment.
  • the first focused ultrasound transducer can also only be used to receive the response sound waves, and the tasks of emitting therapeutic sound waves and detecting sound waves can be realized by another focused ultrasound transducer, specifically, the first focused ultrasound transducer
  • the transducer is used to receive the response ultrasonic wave;
  • the first acoustic wave transceiver assembly may also include a second focused ultrasonic transducer, and the second focused ultrasonic transducer is used to transmit focused detection sound waves to the tissue in the focal region, and send focused ultrasonic waves to the focal region during the treatment time.
  • the tissue emits focused therapeutic sound waves.
  • the embodiment of the present invention does not specifically limit the form of ultrasonic medical equipment emitting therapeutic sound waves to the focal area.
  • the therapeutic sound waves can be focused continuous waves, that is, the amplitude of the therapeutic sound waves is small and the energy is low, but each round The irradiation time is longer (eg, 2s to 5s).
  • ultrasonic medical equipment can also use tissue destruction and micro-tissue destruction to emit therapeutic sound waves to the focal region tissue, that is, the therapeutic sound waves are not continuous waves, but pulse signals with large amplitude and high energy. (This method can effectively reduce the temperature of the focal region tissue, thereby reducing the heat emitted from the focal region tissue to surrounding normal tissues, and improving the safety of HIFU treatment).
  • the control device can control the first sound wave transceiver component to perform sound wave detection in the gap between treatment rounds, so as to obtain the characteristic information of the response sound wave generated by the tissue in the focal region, thereby generating real-time information related to the characteristic sound wave.
  • the prompt information of the focal zone state corresponding to the information.

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Abstract

本发明提供一种超声医疗设备,包括控制装置和第一声波收发组件,控制装置用于在治疗回合之间的间隙,控制第一声波收发组件向焦点区域发射聚焦的检测声波,并接收焦点区域的组织响应于检测声波产生的响应声波;控制装置还用于提取响应声波的特征信息,并根据特征信息生成焦域状态提示信息。在本发明中,控制装置能够在治疗回合之间的间隙控制第一声波收发组件进行声波探测,以获取焦域组织产生的响应声波的特征信息,从而实时生成与该特征信息对应的焦域状态提示信息。医务人员在B超影像中出现雾状伪像时,可根据焦域状态提示信息把控治疗进度,提高了HIFU超声医疗设备的治疗效率和治疗过程的安全性。

Description

一种超声医疗设备 技术领域
本发明涉及超声医疗设备领域,具体地,涉及一种超声医疗设备。
背景技术
高强度聚焦超声(High Intensity Focused Ultrasound,HIFU)手术是一种无创的治疗手段,其利用超声波的可聚焦性和穿透性,使超声波穿过人体后在特定位置聚焦,使得焦点区域的温度升高而发生凝固性坏死,从而达到治疗的目的。影像监控的发展使得这项技术在临床上得到了发展和应用,在实际应用中一般需要借助影像工具来监测HIFU治疗破坏组织的效果,进而确定治疗的有效性和安全性。
在医疗设备领域,影像工具主要采用磁共振成像和B超(B-scan ultrasonography)成像技术实现。其中,磁共振成像设备价格较为昂贵,且每次扫描的时间过长,容易延误HIFU治疗的治疗进程。而B超能够满足HIFU治疗对影像监控的需求,B超引导下的高强度聚焦超声设备拥有实时性好、价格便宜等多重优势。
发明内容
本发明旨在提供一种超声医疗设备,该超声医疗设备能够提高HIFU治疗的效率和安全性。
为实现上述目的,本发明提供一种超声医疗设备,用于在每一治疗回合向组织内部的焦点区域发射治疗声波,以对所述焦点区域的组织进行消融,所述超声医疗设备包括控制装置和第一声波收发组件,所述控制装置用于在所述治疗回合之间的间隙,控制所述第一声波收发组件向所述焦点区域发射聚焦的检测声波,并接收所述焦点区域的组织响应于所述检测声波产生的响应声波;所述控制装置还用于提取 所述响应声波的特征信息,并根据所述特征信息生成焦域状态提示信息。
可选地,所述超声医疗设备还包括B超探头和显示装置,所述控制装置还用于通过所述B超探头获取所述焦点区域的B超影像,并控制所述显示装置显示所述B超影像和所述焦域状态提示信息。
可选地,所述第一声波收发组件包括第一聚焦超声换能器,所述响应声波包括所述检测声波在所述焦点区域反射或散射产生的反射声波或散射声波,所述控制装置用于控制所述第一聚焦超声换能器向所述焦点区域发射聚焦的检测声波,并接收所述反射声波或所述散射声波。
可选地,所述第一声波收发组件包括第一聚焦超声换能器和接收传感器,所述响应声波包括所述检测声波在所述焦点区域反射或散射产生的反射声波或散射声波,所述控制装置用于控制所述第一聚焦超声换能器向所述焦点区域发射聚焦的检测声波,并控制所述接收传感器接收所述反射声波或所述散射声波。
可选地,所述接收传感器包括第二聚焦超声换能器,且所述第二聚焦超声换能器的焦点与所述焦点区域重合。
可选地,所述接收传感器为所述B超探头。
可选地,所述控制装置还用于在第一个治疗回合开始前控制所述第一声波收发组件运行,提取所述响应声波的特征信息作为基准特征信息,并将每一治疗回合后提取得到的特征信息与所述基准特征信息比较得到特征信息差值;所述焦域状态提示信息包括所述特征信息差值的数值。
可选地,所述检测声波包括多个脉冲信号,所述控制装置具体用于由所述响应声波中的多个脉冲信号提取多次特征信息,并将多次提取到的所述特征信息的平均值与所述基准特征信息比较得到所述特征信息差值。
可选地,所述控制装置还用于根据当前治疗深度确定差值阈值,所述焦域状态提示信息还包括当前的所述差值阈值。
可选地,所述控制装置还用于控制所述第一聚焦超声换能器在 每一所述治疗回合发射所述治疗声波。
在本发明提供的超声医疗设备中,控制装置能够在治疗回合之间的间隙控制第一声波收发组件进行声波探测,以获取焦域组织产生的响应声波的特征信息,从而实时生成与该特征信息对应的焦域状态提示信息。医务人员在浏览B超影像时,可结合焦域状态提示信息综合判断焦域组织状态,进而在B超影像中出现雾状伪像时,也可根据焦域状态提示信息把控治疗进度,不必为了解决雾状伪像问题而频繁进行调整B超探头位置等额外操作,提高了HIFU超声医疗设备的治疗效率和治疗过程的安全性。
附图说明
附图是用来提供对本发明的进一步理解,并且构成说明书的一部分,与下面的具体实施方式一起用于解释本发明,但并不构成对本发明的限制。在附图中:
图1是本发明实施例提供的超声医疗设备中控制装置所执行功能的流程图;
图2是本发明另一实施例提供的超声医疗设备中控制装置所执行功能的流程图;
图3是本发明另一实施例提供的超声医疗设备中控制装置所执行功能的流程图;
图4是本发明实施例提供的超声医疗设备中显示装置所显示画面的示意图。
具体实施方式
以下结合附图对本发明的具体实施方式进行详细说明。应当理解的是,此处所描述的具体实施方式仅用于说明和解释本发明,并不用于限制本发明。
本发明的发明人在对HIFU治疗设备进行实验研究的过程中发现,在HIFU治疗设备的工作过程中,B超的监控影像中有时会出现一种雾状伪像,影响图像的质量,在治疗过程中无疑会增加误诊概率。 并且这种雾状伪像仅在B超引导的HIFU系统中存在,传统使用的超声诊断图像中并不存在。发明人对B超探头位置进行多次调整后得到的实验结果表明,这段距离的声波的多重反射和折射有可能就是雾状伪像形成的原因。
由于对于雾状伪像的成因机制不清楚,传统的对伪像的滤波方式仅能够在一定程度上改善B超影像的图像质量,无法完全消除该雾状伪像。在临床治疗过程中一旦出现雾状伪像,医务人员为看清治疗效果需要频繁将B超探头移动到皮肤界面,以减少声波折射和反射对图像质量的影响,而频繁地移动B超探头会不可避免地影响到HIFU手术的治疗进程和治疗的效率。
为解决上述技术问题,本发明提供一种超声医疗设备,该超声医疗设备用于在每一治疗回合向组织内部的焦点区域(焦域)发射治疗声波,以对焦点区域的组织进行消融,该超声医疗设备包括控制装置和第一声波收发组件,该控制装置用于在治疗回合之间的间隙,控制第一声波收发组件向焦点区域发射聚焦的检测声波,并接收焦点区域的组织响应于检测声波产生的响应声波(例如检测声波在焦点区域反射产生的反射声波或散射产生的散射声波);控制装置还用于提取响应声波的特征信息,并根据特征信息生成焦域状态提示信息。
在本发明提供的超声医疗设备中,控制装置用于在治疗回合之间的间隙,控制第一声波收发组件向焦点区域发射聚焦的检测声波,并接收焦点区域的组织产生的响应声波(反射声波或散射声波),随着焦点区域的组织在超声波作用下消融,焦点区域组织的声阻抗也随之发生变化,从而使响应声波的特征信息发生改变,进而可通过特征信息反映焦域组织的状态(消融程度)。
控制装置在治疗回合之间的间隙控制第一声波收发组件进行声波探测,以获取焦域组织产生的响应声波的特征信息,从而实时生成与该特征信息对应的焦域状态提示信息。医务人员在浏览B超影像时,可结合焦域状态提示信息综合判断焦域组织状态,进而在B超影像中出现雾状伪像时,也可根据焦域状态提示信息把控治疗进度,不必为了解决雾状伪像问题而频繁进行调整B超探头位置等额外操 作,提高了HIFU超声医疗设备的治疗效率和治疗过程的安全性。
本发明实施例对声波的特征信息不作具体限定,只要该特征信息能够随着焦域组织消融状态的改变而变化,该特征信息即可用于反映焦域组织的状态,例如,可选地,该特征信息可以包括声波的相位(声波在组织中的传播速率随组织消融程度的改变而改变)、幅值、能量(与声波幅值在时间上的积分成正比,声波能量、幅值的衰减程度随组织消融程度的改变而改变),等等。
本发明实施例对控制装置根据特征信息所生成的焦域状态提示信息的形式不作具体限定,只要能够直观明了地向医务人员展示、提醒组织消融进度即可,例如,可选地,该焦域状态提示信息可以以数字、图像、声音提示、可穿戴设备的震动提醒等多种形式存在。
为便于医务人员在B超影像中出现雾状伪像时及时浏览焦域状态提示信息,作为本发明的一种优选实施方式,超声医疗设备还包括B超探头和显示装置,控制装置还用于通过B超探头获取焦点区域的B超影像,并控制显示装置显示B超影像和焦域状态提示信息。
在本发明实施例中,焦域B超影像和焦域状态提示信息均通过显示装置的屏幕进行显示,从而在B超影像中出现雾状伪像时,医务人员可直接浏览同一显示装置上显示的焦域状态提示信息,待B超影像中的雾状伪像消失后可再无缝切换至B超影像浏览焦域组织的完整图像信息,进而提高了医务人员的操作效率。
在HIFU治疗过程中,同一深度(即与皮肤表面之间的距离,HIFU治疗设备可通过换能器坐标位置自动确定治疗深度)同一类型的组织(如同一脏器、肌肉组织、结缔组织)响应于同一检测声波产生的响应声波基本一致,且组织由消融开始到消融完毕响应声波的特征信息变化量也基本一致,因此,组织消融的程度可通过响应声波特征信息的变化量表示。
具体地,为进一步提高医务人员根据特征信息判断焦域组织状态的便捷性,优选地,如图1所示,控制装置还用于在第一个治疗回合开始前控制第一声波收发组件运行(即执行步骤S1),提取响应声波的特征信息作为基准特征信息,并将每一治疗回合后提取得到的 特征信息与基准特征信息比较得到特征信息差值(即执行步骤S3);焦域状态提示信息包括特征信息差值的数值。
如同图1所示为本发明实施例中控制装置所执行功能的流程图,在本发明实施例中,焦域状态提示信息包括特征信息差值的数值,从而在HIFU治疗过程中,医务人员可根据特征信息差值的数值大小直观地判断焦域组织的消融程度,进而提高了医务人员根据特征信息判断焦域组织状态的便捷性。
为提高焦域状态提示信息的可靠性,作为本发明的一种优选实施方式,检测声波包括在同一间隙(即在相邻两治疗回合之间)发出的多个脉冲信号,控制装置具体用于由响应声波中的多个脉冲信号提取多次特征信息,并将多次提取到的特征信息的平均值与基准特征信息比较得到特征信息差值。
本发明实施例对检测声波所包括的脉冲信号数量不作具体限定,只要不影响正常的治疗进程即可,例如,检测声波可以是单脉冲、双脉冲、三脉冲,或包括三个以上的脉冲信号。响应声波也将包括对应数量的多个脉冲信号,控制装置根据响应声波中多个脉冲信号提取多个特征信息,并将该多个特征信息的平均值与基准特征信息比较得到特征信息差值,从而提高了特征信息的准确性,进而提高了焦域状态提示信息的可靠性。
为进一步提高焦域状态提示信息的可靠性,控制装置还可以根据响应声波中多个脉冲信号对应的多次提取到的特征信息分析得到其他信息,作为焦域状态提示信息中的额外内容,例如,可选地,控制装置还用于确定响应声波中多个脉冲信号对应的多次提取到的特征信息的均方差。
考虑到不同深度的组织在消融过程中对应的响应声波的特征信息变化量之间存在差别,为进一步提高医务人员根据特征信息判断焦域组织状态的便捷性,作为本发明的一种优选实施方式,控制装置还用于根据当前治疗深度确定差值阈值,焦域状态提示信息还包括当前的差值阈值。
在本发明实施例中,焦域状态提示信息除特征信息差值外,还 包括对应于当前治疗深度的差值阈值,从而医务人员可以在B超影像中出现雾状伪像后,同时通过焦域状态提示信息确定特征信息差值和差值阈值,从而直观地了解特征信息差值是否已经达到差值阈值,进而提高了医务人员根据特征信息判断焦域组织状态的便捷性,以及HIFU治疗的安全性。
为便于医务人员对特征信息差值与差值阈值之间的大小关系,进一步提高HIFU治疗的安全性和治疗效率,作为本发明的一种优选实施方式,控制装置控制显示装置所显示的焦域状态提示信息包括特征信息差值与差值阈值对应的柱状图,且两柱状图并排设置。
具体地,如图4所示,在显示装置所显示的画面中,特征信息差值与差值阈值对应的柱状图位于B超影像的一侧,且两柱状图的高度分别与二者对应的数值大小成正比。从而在对任意深度的组织进行HIFU治疗的过程中,差值阈值对应的柱状图高度不变,而特征信息差值对应的柱状图高度将随着多次更新逐渐接近差值阈值的柱状图高度,当二者高度平齐时,则说明焦域组织已被消融,医务人员在B超影像中出现雾状伪像时,不必仔细阅读特征信息差值与差值阈值的数值大小,仅浏览图像即可快速确认焦域组织情况。
在本发明的其他实施例中,特征信息差值还可以直接以波形图的形式展示在显示装置的图像中,当特征信息为幅值时,差值阈值可表示为波形图图案中的上下两条基准线,在特征信息差值对应的波形图案超出上下两条基准线所限定的范围时,即可判定特征信息差值已超出差值阈值。
为扩展医务人员获取到的信息总量,以便于医务人员综合分析焦域组织情况,焦域状态提示信息除以图形形式展示的特征信息差值与差值阈值外,还可包括文字说明信息,例如,特征信息差值与差值阈值对应的数值大小(即图4中柱状图案顶部的“xxx”),通过多脉冲方式获取的多个特征信息差值的方差,等等。
为提高超声医疗设备的智能化程度,并进一步提高HIFU治疗的安全性,优选地,如图2所示,控制装置还用于在特征信息超出差值阈值时,执行步骤S4、控制超声医疗设备停止发射治疗声波,或者, 发出告警提示信息(例如,可控制蜂鸣器发出声音提示、控制显示装置弹出告警提示、控制显示装置屏幕闪烁、控制可穿戴设备发出震动提醒,等等)。
本发明实施例对如何确定各治疗深度对应的差值阈值不作具体限定,例如,该差值阈值可通过分析实际治疗数据得到。
为提高差值阈值的精确性,进一步提高焦域状态提示信息的可靠性,作为本发明的一种优选实施方式,控制装置具有自动记录并分析差值阈值的功能,具体地,如图3所示,控制装置可在进行组织消融(即执行步骤S02、进行高强度聚焦超声治疗(HIFU治疗)),且B超影像中未出现雾状伪像(是否出现雾状伪像可由机器根据画面灰度自动识别,或人工协助判断)的情况下,自动在非治疗时间控制第一声波收发组件发射检测声波,并接收响应声波,并在焦域组织消融时(可由机器根据画面灰度进行判断,也可人工协助判断),将响应声波的特征信息的总变化量记录为当前治疗深度对应的差值阈值(即执行步骤S04)。
例如,为降低医务人员的工作负担,作为本发明的一种优选实施方式,控制装置可全程自动判断。具体地,在第一治疗深度,且(控制装置根据画面判断)B超影像中未出现雾状伪像时,进行HIFU治疗,直至控制装置根据B超影像中的灰度变化情况判定组织已消融,此时回波特征信息的总变化为K,则第一治疗深度对应的差值阈值信息为K。同理,在第二治疗深度,且B超影像中未出现雾状伪像时,进行HIFU治疗,直至控制装置根据B超影像中的灰度变化情况判定组织已消融,此时回波特征信息的总变化为L,则第二治疗深度对应的差值阈值信息为L。
为简化设备结构,作为本发明的一种优选实施方式,第一声波收发组件包括一个兼具发射检测声波和接收响应声波功能的聚焦超声换能器,该响应声波可以为反射声波,具体地,第一声波收发组件包括第一聚焦超声换能器,响应声波包括检测声波在焦点区域反射或散射产生的反射声波或散射声波,控制装置用于控制第一聚焦超声换能器向焦点区域发射聚焦的检测声波,并接收该反射声波或散射声波。
在本发明的一些实施例中,可以仅通过聚焦超声换能器向焦域发射检测声波,由其他装置接收响应声波,具体地,第一声波收发组件包括第一聚焦超声换能器和接收传感器,响应声波包括检测声波在焦点区域反射或散射产生的反射声波或散射声波,控制装置用于控制第一聚焦超声换能器向焦点区域发射聚焦的检测声波,并控制接收传感器接收该反射声波或散射声波。
本发明实施例对接收传感器的结构不作具体限定,例如,接收传感器可以为超声波换能器。当接收传感器为超声波换能器时,为提高接收反射声波或散射声波的信号稳定性,优选地,接收传感器包括第二聚焦超声换能器,且第二聚焦超声换能器的焦点与焦点区域重合。
为简化设备结构,作为本发明的一种优选实施方式,接收传感器还可以为前面所述的用于获取焦点区域B超影像的B超探头(采集B超影像的声波与检测声波的频率、振幅等信息之间存在差别,以便于对B超探头所接收到的多种声波信息进行区分)。
为使B超的扇扫面和焦点产生损伤在同一个轴向平面上,优选地,B超探头可安装在治疗换能器(即用于向焦域组织聚焦超声波的换能器)的中心位置。
本发明实施例对超声医疗设备如何向焦域发射治疗声波不作具体限定,例如,可选地,超声医疗设备还可以包括第二声波收发组件,用于在治疗时间向焦域发射聚焦的治疗声波。
为进一步简化设备结构,作为本发明的一种优选实施方式,控制装置还用于控制第一聚焦超声换能器在每一治疗回合发射治疗声波。即,在本发明实施例中,第一聚焦超声换能器既具有发射检测声波、进行焦域组织状态检测的功能,又可以在治疗时间向焦域组织发射聚焦的治疗声波,从而通过同一聚焦超声换能器实现治疗、检测功能,进一步简化了设备结构。
在本发明的其他实施例中,第一聚焦超声换能器还可以仅用于接收响应声波,发射治疗声波和检测声波的任务可由另一聚焦超声换能器实现,具体地,第一聚焦超声换能器用于接收响应超声波;第一声波收发组件还可以包括第二聚焦超声换能器,第二聚焦超声换能器 用于向焦域组织发射聚焦的检测声波,以及在治疗时间向焦域组织发射聚焦的治疗声波。
本发明实施例对超声医疗设备向焦域发射治疗声波的形式不作具体限定,例如,治疗声波可以为聚焦的连续波,即,治疗声波的幅值较小、能量较低,但每一回合的辐照时间较长(例如,2s至5s)。或者,在本发明的其他实施例中,超声医疗设备还可采用组织损毁术和微组织损毁术对焦域组织发射治疗声波,即治疗声波不是连续波,而是幅值大、能量高的脉冲信号(该方法能够有效降低焦域组织温度,进而减少焦域组织向周围正常组织散发的热量,提高HIFU治疗的安全性)。
在本发明提供的超声医疗设备中,控制装置能够在治疗回合之间的间隙控制第一声波收发组件进行声波探测,以获取焦域组织产生的响应声波的特征信息,从而实时生成与该特征信息对应的焦域状态提示信息。医务人员在浏览B超影像时,可结合焦域状态提示信息综合判断焦域组织状态,进而在B超影像中出现雾状伪像时,也可根据焦域状态提示信息把控治疗进度,不必为了解决雾状伪像问题而频繁进行调整B超探头位置等额外操作,提高了HIFU超声医疗设备的治疗效率和治疗过程的安全性。
可以理解的是,以上实施方式仅仅是为了说明本发明的原理而采用的示例性实施方式,然而本发明并不局限于此。对于本领域内的普通技术人员而言,在不脱离本发明的精神和实质的情况下,可以做出各种变型和改进,这些变型和改进也视为本发明的保护范围。

Claims (10)

  1. 一种超声医疗设备,用于在每一治疗回合向组织内部的焦点区域发射治疗声波,以对所述焦点区域的组织进行消融,其特征在于,所述超声医疗设备包括控制装置和第一声波收发组件,所述控制装置用于在所述治疗回合之间的间隙,控制所述第一声波收发组件向所述焦点区域发射聚焦的检测声波,并接收所述焦点区域的组织响应于所述检测声波产生的响应声波;所述控制装置还用于提取所述响应声波的特征信息,并根据所述特征信息生成焦域状态提示信息。
  2. 根据权利要求1所述的超声医疗设备,其特征在于,所述超声医疗设备还包括B超探头和显示装置,所述控制装置还用于通过所述B超探头获取所述焦点区域的B超影像,并控制所述显示装置显示所述B超影像和所述焦域状态提示信息。
  3. 根据权利要求2所述的超声医疗设备,其特征在于,所述第一声波收发组件包括第一聚焦超声换能器,所述响应声波包括所述检测声波在所述焦点区域反射或散射产生的反射声波或散射声波,所述控制装置用于控制所述第一聚焦超声换能器向所述焦点区域发射聚焦的检测声波,并接收所述反射声波或所述散射声波。
  4. 根据权利要求2所述的超声医疗设备,其特征在于,所述第一声波收发组件包括第一聚焦超声换能器和接收传感器,所述响应声波包括所述检测声波在所述焦点区域反射或散射产生的反射声波或散射声波,所述控制装置用于控制所述第一聚焦超声换能器向所述焦点区域发射聚焦的检测声波,并控制所述接收传感器接收所述反射声波或所述散射声波。
  5. 根据权利要求4所述的超声医疗设备,其特征在于,所述接收传感器包括第二聚焦超声换能器,且所述第二聚焦超声换能器的焦 点与所述焦点区域重合。
  6. 根据权利要求4所述的超声医疗设备,其特征在于,所述接收传感器为所述B超探头。
  7. 根据权利要求1至6中任意一项所述的超声医疗设备,其特征在于,所述控制装置还用于在第一个治疗回合开始前控制所述第一声波收发组件运行,提取所述响应声波的特征信息作为基准特征信息,并将每一治疗回合后提取得到的特征信息与所述基准特征信息比较得到特征信息差值;所述焦域状态提示信息包括所述特征信息差值的数值。
  8. 根据权利要求7所述的超声医疗设备,其特征在于,所述检测声波包括多个脉冲信号,所述控制装置具体用于由所述响应声波中的多个脉冲信号提取多次特征信息,并将多次提取到的所述特征信息的平均值与所述基准特征信息比较得到所述特征信息差值。
  9. 根据权利要求7所述的超声医疗设备,其特征在于,所述控制装置还用于根据当前治疗深度确定差值阈值,所述焦域状态提示信息还包括当前的所述差值阈值。
  10. 根据权利要求3至6中任意一项所述的超声医疗设备,其特征在于,所述控制装置还用于控制所述第一聚焦超声换能器在每一所述治疗回合发射所述治疗声波。
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