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CN100542635C - 高强度聚焦超声治疗装置和方法 - Google Patents

高强度聚焦超声治疗装置和方法 Download PDF

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CN100542635C
CN100542635C CNB2005100003513A CN200510000351A CN100542635C CN 100542635 C CN100542635 C CN 100542635C CN B2005100003513 A CNB2005100003513 A CN B2005100003513A CN 200510000351 A CN200510000351 A CN 200510000351A CN 100542635 C CN100542635 C CN 100542635C
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ultrasonic transducer
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CN1803224A (zh
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陈文直
王智彪
王芷龙
林涛
赵纯亮
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Chongqing Haifu Medical Technology Co ltd
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Priority to JP2007549778A priority patent/JP4833997B2/ja
Priority to RU2007126074/14A priority patent/RU2359721C2/ru
Priority to PCT/CN2005/001175 priority patent/WO2006072196A1/zh
Priority to BRPI0518496-7A priority patent/BRPI0518496A2/pt
Priority to KR1020077015736A priority patent/KR100895358B1/ko
Priority to AU2005324269A priority patent/AU2005324269B2/en
Priority to US11/794,930 priority patent/US20080188745A1/en
Priority to CA002591270A priority patent/CA2591270C/en
Priority to ES05771731T priority patent/ES2396362T3/es
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00Ultrasound therapy
    • 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
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37Surgical systems with images on a monitor during operation
    • A61B2090/378Surgical systems with images on a monitor during operation using ultrasound

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Abstract

本发明的高强度聚焦超声治疗装置具有通常的超声换能器、图像采集装置、用于驱动超声换能器的驱动单元以及使超声换能器和图像采集装置移动的运动机构。另外,该高强度聚焦超声治疗装置还具有:信号处理单元,与图像采集装置连接,在治疗前接收并存储靶区原始图像,在高强度聚焦超声治疗过程中的某一特定时刻,接收并存储靶区图像,并根据所存储的治疗前图像和治疗后图像来判断治疗效果;以及控制单元,分别与信号处理单元、驱动单元和运动机构连接,当信号处理单元判断已达到治疗要求时,控制驱动单元和运动机构,使超声换能器停止工作,当信号处理单元判断还没有达到治疗要求时,控制驱动单元和运动机构,使超声换能器继续工作。

Description

高强度聚焦超声治疗装置和方法
技术领域
本发明涉及一种高强度聚焦超声治疗装置和方法,尤其涉及根据超声图像的灰度变化来控制治疗超声波的发射和停止的装置和方法。
背景技术
医学研究发现肿瘤细胞的耐热性比正常细胞要差,在42.5℃以上的温度环境下,30分钟内肿瘤细胞死亡,而正常细胞损伤较轻且可逆转。高强度聚焦超声肿瘤治疗系统就是根据肿瘤细胞的这一特点,以超声波为能量源,利用其穿透性和可聚焦性,将探头发射出的平均声强较低的超声波通过介质耦合,经过皮肤进入人体肿瘤组织,聚焦或者汇聚到一个空间点,形成一个平均声强在1000W/m2以上的焦域(焦域大小:Φ3mm×8mm),使该焦域瞬时(0.1秒到5秒)产生强烈的温度升高(高于70℃),加上其空化作用(即强超声在液体中产生类似雾状的气泡,其形成和消失可以产生极高的温度和压力,从而使组织受到严重破坏)和机械振荡作用,破坏焦域处的组织。通过对肿瘤进行如此由点到线、由线到面、由面到体逐点扫描的固化治疗,从而使整个肿瘤组织固化,实现治疗的目的。
随着超声治疗技术的发展,超声波联合B超装置等成像设备来检测治疗肿瘤也取得了长足的进步,现有超声治疗设备中的B超装置主要用于治疗前对肿瘤的定位和观察,但是治疗后靶区是否达到了所需的治疗剂量,靶区组织是否形成了凝固性坏死,对于术后的疗效评价,现有设备采用的方法是靠术后过一段时间进行核磁共振或CT检查来进行的,这样就存在很多缺点,由于不能及时观察治疗效果,治疗剂量只能凭经验控制,如果是剂量不足,就不能有效地杀死病变组织,达不到治疗的效果,而如果是剂量超过所需,则可能损伤到正常的组织,这样就存在很大的安全因素。因此治疗过程中对治疗效果进行实时评价就非常必要。
发明内容
为了解决上述问题,本发明的高强度聚焦超声治疗装置具有:超声换能器,用于向治疗靶区发射高强度聚焦超声波;图像采集装置,用来定位治疗靶区并且采集治疗靶区的图像;驱动单元,与上述超声换能器连接,驱动上述超声换能器向治疗靶区发射超声波;以及运动机构,与上述超声换能器连接,使上述超声换能器和上述图像采集装置一同移动,对治疗靶区进行扫描,其特征在于,该高强度聚焦超声治疗装置还具有:信号处理单元,与图像采集装置连接,在治疗前接收并存储图像采集装置采集的靶区原始图像,在高强度聚焦超声治疗过程中的某一特定时刻,接收并存储图像采集装置采集的靶区图像,上述信号处理单元分别计算上述治疗前存储的靶区原始图像和治疗过程中采集的靶区图像的灰度值,进而计算治疗前后的靶区图像灰阶变化值,当治疗前后的灰阶变化值超过某一规定值时,则判断已达到治疗要求,当灰阶变化值没有超过上述规定值时,则判断还没有达到治疗要求;以及控制单元,分别与信号处理单元、驱动单元和运动机构连接,当信号处理单元判断已达到治疗要求时,控制驱动单元和运动机构,使超声换能器停止工作,当信号处理单元判断还没有达到治疗要求时,控制驱动单元和运动机构,使超声换能器继续工作。
根据上述本发明的高强度聚焦超声治疗装置,就能够在治疗过程中实时地对治疗靶区的治疗效果进行评价,并根据评价结果来决定是对靶区继续进行治疗,还是停止治疗。从而能够准确地掌握治疗剂量,达到最佳的治疗效果。
附图说明
图1所示为本发明的结构框图。
图2所示为本发明的工作流程图。
图3所示为治疗前组织的B超图像。
图4所示为治疗后组织的B超图像。
图5所示为治疗前组织的B超图像。
图6所示为治疗后组织的B超图像。
具体实施方式
以下参照图1,对本发明的结构进行说明。如图1所示,本发明的高强度聚焦超声治疗装置具有通常的超声换能器1、图像采集装置2、驱动单元6、运动机构7。此外,为了实现本发明的目的,还设置有信号处理单元4和控制单元5。其中,超声换能器1用于向靶区发射高强度聚焦超声波。图像采集装置2安装在超声换能器1上,用来定位肿瘤并且采集治疗靶区的图像,可以采用现有的成像设备,在本发明中,以B超装置为例进行说明。信号处理单元4与B超装置2连接,用来接收并存储B超装置2采集的图像,然后根据治疗前原始图像数据来计算评价当前靶区图像的灰阶变化。显示器3与信号处理单元4连接,用于显示信号处理单元4输出的图像。驱动单元6与超声换能器1连接,在控制单元5的控制下,驱动超声换能器1向治疗靶区发射超声波。运动机构7与超声换能器1连接,在控制单元5的控制下,使超声换能器1和B超装置2一同移动。控制单元5分别与信号处理单元4、驱动单元6和运动机构7连接,接收信号处理单元4输出的靶区图像灰阶变化的计算评价结果,然后根据该计算评价结果来控制驱动单元6和运动机构7的工作。
以下参照图2,对本发明高强度聚焦超声治疗装置的工作流程进行说明。如图2所示,在开始治疗后,进入步骤S1,B超装置2采集靶区原始图像并将靶区原始图像传送给信号处理单元4,信号处理单元4计算出靶区图像的原始灰度值,然后存储该原始灰度值,作为随后计算评价的依据。
在步骤S2中,控制单元5控制驱动单元6和运动机构7,使超声换能器1发射高强度聚焦超声并对靶区进行扫描,来对靶区的肿瘤细胞进行治疗。
在某一特定时刻,例如进行至少一次扫描运动之后,进入步骤S3,B超装置2再次采集靶区图像并将靶区图像传送给信号处理单元4,信号处理单元4计算治疗后的靶区图像的灰度值,然后根据所存储的原始灰度值,来计算治疗后的靶区图像的灰阶变化值。
然后进入步骤S4,信号处理单元4判断所计算出的靶区图像灰阶变化值是否超过某一规定值。如果靶区图像灰阶变化值超过规定值,则意味着对靶区的超声治疗已经达到了治疗剂量,这时可以停止发射高强度聚焦超声。相反,如果靶区图像灰阶变化值没有超过规定值,则意味着对靶区的超声治疗还没有达到治疗剂量,应继续发射高强度聚焦超声进行治疗。本发明人对动物样本进行了大量的实验发现,靶区声像图前后灰阶变化除了与超声功率、辐射时间有关外,还与辐射深度、组织结构、组织功能状态和治疗方式有关,但只要灰阶变化超过5—10个灰阶,靶区的肿瘤组织就发生了凝固性坏死。本发明将灰度值平均分布在[0~255]空间范围内,0表示全黑,255表示全白。
灰度值和灰阶变化值的计算方法是计算机从监控设备B超上采集特定时刻的图像,如治疗前、治疗后的静态图像。计算机系统自动记录采集图像时的位置、能量及设备参数。利用计算机图形学算法,比如差运算、卷积等操作,比较指定位置的灰阶变化。比较区域可以是点、线(直线、曲线、治疗轨迹等)、面(矩形、手动勾画)等等。根据前后图像治疗轨迹的位置,计算设定区域内的灰阶特征值,比如灰阶总值、灰阶平均值、灰阶加权值(总和、平均等)、区域中心灰阶值等等;再将前后的灰阶特征值进行比较,比如差运算、卷积等等。
如果在步骤S4中判断靶区图像灰阶变化值超过规定值,则信号处理单元4向控制单元5发送停止指令,控制单元5根据停止指令,控制驱动单元6和运动机构7,使超声换能器1停止发射高强度聚焦超声和扫描,即结束治疗。
如果在步骤S4中判断靶区图像灰阶变化值没有超过规定值,则信号处理单元4向控制单元5发送继续治疗指令,返回步骤S2。在步骤S2中,控制单元5根据该指令,控制驱动单元6和运动机构7,使超声换能器1继续发射高强度聚焦超声和扫描,对靶区继续进行治疗。
图3和图4为同一个动物肝脏组织在治疗前后的对比B超图像,图3为治疗前图像,图4为经过高强度聚焦超声治疗后的治疗图像,可明显看出靶区的焦点处的灰度产生了变化,通过解剖,这部分肝脏组织形成了凝固性坏死,达到了治疗的要求。这也证明了此方法对疗效进行评价是行之有效的。
图5和图6为另一个动物肝脏组织在治疗前后的对比B超图像,图5为治疗前图像,图6为经过高强度聚焦超声治疗后的治疗图像,此结果和现象与图3、图4相同,这里就不再赘述。
综上所述,通过计算靶区图像灰阶变化值,可以在治疗过程中实时地对治疗效果进行评价,并根据评价结果来调整高强度聚焦超声的治疗剂量,一次可以避免治疗剂量不足而不能有效地杀死肿瘤组织,或者治疗剂量过大而损伤到正常的组织。
以上所述仅为本发明具体实施例,并非用以限定本发明的保护范围,凡其它未脱离本发明所揭示的精神下所完成的等效改变或变形,均应包含在所述的专利申请的范围内。

Claims (3)

1.一种高强度聚焦超声治疗装置,具有:超声换能器,用于向治疗靶区发射高强度聚焦超声波;图像采集装置,用来定位治疗靶区并且采集治疗靶区的图像;驱动单元,与上述超声换能器连接,驱动上述超声换能器向治疗靶区发射超声波;以及运动机构,与上述超声换能器连接,使上述超声换能器和上述图像采集装置一同移动,对治疗靶区进行扫描,其特征在于,
该高强度聚焦超声治疗装置还具有:
信号处理单元,与图像采集装置连接,在治疗前接收并存储图像采集装置采集的靶区原始图像,在高强度聚焦超声治疗过程中的某一特定时刻,接收并存储图像采集装置采集的靶区图像,上述信号处理单元分别计算上述治疗前存储的靶区原始图像和治疗过程中采集的靶区图像的灰度值,进而计算治疗前后的靶区图像灰阶变化值,当治疗前后的灰阶变化值超过某一规定值时,则判断已达到治疗要求,当灰阶变化值没有超过上述规定值时,则判断还没有达到治疗要求;以及
控制单元,分别与信号处理单元、驱动单元和运动机构连接,当信号处理单元判断已达到治疗要求时,控制驱动单元和运动机构,使超声换能器停止工作,当信号处理单元判断还没有达到治疗要求时,控制驱动单元和运动机构,使超声换能器继续工作。
2.根据权利要求1所述的高强度聚焦超声治疗装置,其特征在于,上述灰阶变化值的规定值为5个灰阶,其中,灰阶值平均分布在0~255空间范围内,0表示全黑,255表示全白。
3.根据权利要求1至2任意一项所述的高强度聚焦超声治疗装置,其特征在于,上述特定时刻指超声换能器对治疗靶区进行至少一次扫描运动之后的时刻。
CNB2005100003513A 2005-01-10 2005-01-10 高强度聚焦超声治疗装置和方法 Expired - Lifetime CN100542635C (zh)

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Application Number Priority Date Filing Date Title
CNB2005100003513A CN100542635C (zh) 2005-01-10 2005-01-10 高强度聚焦超声治疗装置和方法
US11/794,930 US20080188745A1 (en) 2005-01-10 2005-08-02 Method and Apparatus for High-Intensity Focused Ultrasound Therapy
RU2007126074/14A RU2359721C2 (ru) 2005-01-10 2005-08-02 Способ и устройство для сфокусированной ультразвуковой терапии высокой интенсивности
PCT/CN2005/001175 WO2006072196A1 (fr) 2005-01-10 2005-08-02 Appareil et procede therapeutiques a ultrasons focalises a haute intensite
BRPI0518496-7A BRPI0518496A2 (pt) 2005-01-10 2005-08-02 dispositivo terapÊutico por ultra-som focalizado de alta intensidade e mÉtodo
KR1020077015736A KR100895358B1 (ko) 2005-01-10 2005-08-02 고강도 집속형 초음파 치료 장치 및 방법
EP05771731A EP1837051B1 (en) 2005-01-10 2005-08-02 High intensity focused ultrasound therapeutic apparatus
JP2007549778A JP4833997B2 (ja) 2005-01-10 2005-08-02 高強度集束超音波療法のための方法および装置
CA002591270A CA2591270C (en) 2005-01-10 2005-08-02 Method and apparatus for high-intensity focused ultrasound therapy
ES05771731T ES2396362T3 (es) 2005-01-10 2005-08-02 Aparato terapéutico de ultrasonido enfocado de alta intensidad
AU2005324269A AU2005324269B2 (en) 2005-01-10 2005-08-02 Method and apparatus for high-intensity focused ultrasound therapy

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JP4833997B2 (ja) 2011-12-07
EP1837051A4 (en) 2009-09-09
CA2591270C (en) 2009-09-01
JP2008526326A (ja) 2008-07-24
ES2396362T3 (es) 2013-02-21
WO2006072196A1 (fr) 2006-07-13
CN1803224A (zh) 2006-07-19
BRPI0518496A2 (pt) 2008-11-25
EP1837051B1 (en) 2012-06-13
EP1837051A1 (en) 2007-09-26
AU2005324269A1 (en) 2006-07-13
RU2007126074A (ru) 2009-02-20
AU2005324269B2 (en) 2009-09-10
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KR100895358B1 (ko) 2009-04-29

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