CN211856471U - 回声医疗器械回声反射性量化测试系统 - Google Patents

回声医疗器械回声反射性量化测试系统 Download PDF

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CN211856471U
CN211856471U CN201921364733.8U CN201921364733U CN211856471U CN 211856471 U CN211856471 U CN 211856471U CN 201921364733 U CN201921364733 U CN 201921364733U CN 211856471 U CN211856471 U CN 211856471U
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范青青
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Abstract

本实用新型涉及一种回声医疗器械回声反射性量化测试系统，包括夹具组件和超声波诊断设备，其特征在于，夹具组件包括：框架；探头夹具，探头夹具具有第一导杆和用于保持超声波探头的探头夹，探头夹可动地保持在第一导杆上，并且超声波探头连接到超声波诊断设备；和医疗器械试样夹具，医疗器械试样夹具具有第二导杆和用于保持医疗器械试样的医疗器械试样夹，医疗器械试样夹可动地保持在第二导杆上；其中，在框架上设有导轨，第一导杆的两端和第二导杆的两端分别可动地设置在导轨中。

Description

回声医疗器械回声反射性量化测试系统
技术领域
本实用新型涉及回声反射性量化测试系统，尤其是涉及回声医疗器械的回声反射性量化测试系统。
背景技术
在临床中超声波检查已经越来越普及，并且很多情况下在妇产科、腹部和心脏诊断中是首选，这是因为超声波检查是无创伤、快速且便宜的手段。
随着介入性超声波检查的发展，越来越多地在回声医疗器械的辅助下采用B型灰阶超声波图像来在线监测穿刺，以减小造成额外创伤风险的失败率。但是，对于医疗器械厂商来说最关键的问题是如何在产品开发周期中量化地表征回声医疗器械的回声反射性。
虽然几十年前研究者就意识到了回声反射性的量化对于标准回声分析来说很关键，但是临床判断回声反射性主要还是依赖于主观评估来描述感兴趣区域(ROI)的形态和明度。迄今为止，还没有关于回声反射性分析量化方法的标准或指南。
已经做出了一些尝试对常用于颈动脉斑块/狭窄的B型灰阶图像给出量化描述，但聚焦于组织分类的努力还相当有限。在这些尝试中，所有的数据(具体地是B型超声波图像)都是由有至少十年临床超声波诊断经验的超声波检查医师产生的，他们致力于寻找对于斑块或一定组织的量化分析结果和历史结果之间的关联性。极少有人关注对医疗器械量化分析来指导对回声医疗器械的表征。
之前对婴儿肝或肾超声波评价做了一些工作，这在某种程度上提供了通过对标准组织模拟材料进行测试以建立灰阶直方图超声波明度指标(A.C.Lamont,“Ultrasoundassessment of liver and kidney brightness in infants,use of the gray-levelhistogram”,Investigative Radiology,1995,30(4),232-238)来进行进一步研究的基础。但是，在这方面并未找到更多的工作成果。以前对灰阶图像的量化分析主要是用于颈动脉斑块。由K.Nagano等人进行的一项工作是通过对斑块进行集成背向散射分析来评价回声反射性，但是需要仅用一定的超声波装置来进行测量(K.Nagano et al,“Quantitativeevaluation of carotid plaque echogenicity by integrated backscatter analysis:correlation with symptomatic history and histologic findings”,CerebrovascularDiseases,2008,26,578-583)。
其他一些之前的尝试是，利用机构内部编写的程序或普通商业图像处理软件(例如Adobe Photoshop)对灰阶图像进行像素分析。有一种尝试是在应用两种不同的图像分析软件之间进行比较。采用所有这些尝试，研究者努力寻找灰阶中位数(GSM)与组织纹理历史分析之间的关联。实际中，很难确定一种适用于参数设定各异的不同超声波设备的图像分析标准方法，因为ROI明度绝对值受设备本身、探头类型以及增益设定等的影响。GSM计算的另一种研发是归一法，预先把血液GSM定义为0并把血管外膜GSM定义为另一值。一些尝试得出了具有一定关联性的良好结果，但另一些尝试则没有。D.Craiem等人意识到了具有相同GSM值但斑块明度的不同分散，指出了ROI的GSM某种程度上反映了仅一小部分ROI的绝对明度，但几乎不能反映ROI的平均明度(D.Craiem et al,“Atheromatous plaques:quantitative analysis of the echogenicity of different layers”,Rev EspCardiol,2009,62(9)984-991)。
D.Pazinato等人采用了GSM方法来对血液、血脂、肌肉、纤维和钙等其他组织的数据集分类(D.V.Pazinota,“Pixel-level tissue classification for ultrasoundimages”,IEEE Journal of Biomedical and Health Informatics,2016,20(1),256-267)。他们借用了先前的GSM定义方法，即分别把血液和血管外膜定义为0和190。在他们的工作结果中，GSM分析和历史结果之间的关联性相对较低。
J.A.Manley采用肝为基准对肾进行了量化分析(J.A.Manley,“How echogenic isechogenic？Quantitative acoustics of the renal cortex”,American Journal ofKidney Diseases,2001,37(4),706-711)。但是，他们没有把某一ROI定义为最大和最小像素密度来进行归一。A.D.Luiza等人也进行了类似工作：采用GSM方法对肾组织进行量化表征，把全黑区域定义为0并把肾筋膜定义为200，还提出了不同肾组织的灰阶范围(A.Luiza,“Ultrasound tissue characterization of the normal kidney”,UltrasoundQuarterly,2012,28(4)275-280)。
实用新型内容
本实用新型旨在开发一种标准测试系统，用于对在手术过程中进行在线监测的医疗器械的回声反射性进行量化表征，在灰阶超声波图像中识别ROI相对于环境的明度平均值差异。例如，本实用新型可用于对经皮肾镜手术的回声医疗器械进行回声反射性测试。例如，回声医疗器械是球囊扩张器(或者说球囊导管)。本实用新型也可用于对受测介质进行回声反射性测试。
根据本实用新型，提供了一种回声医疗器械回声反射性量化测试系统，包括夹具组件和超声波诊断设备，其特征在于，夹具组件包括：框架；探头夹具，探头夹具具有第一导杆和用于保持超声波探头的探头夹，探头夹可动地保持在第一导杆上，并且超声波探头连接到超声波诊断设备；和医疗器械试样夹具，医疗器械试样夹具具有第二导杆和用于保持医疗器械试样的医疗器械试样夹，医疗器械试样夹可动地保持在第二导杆上；其中，在框架上设有导轨，第一导杆的两端和第二导杆的两端分别可动地设置在导轨中。
根据一个实施例，在探头夹在第一导杆上固定不动的情况下，医疗器械试样夹沿第二导杆移动。
根据一个实施例，在医疗器械试样夹在第二导杆上固定不动的情况下，探头夹沿第一导杆移动。
根据一个实施例，探头夹沿第一导杆移动并同时医疗器械试样夹沿第二导杆移动。
根据一个实施例，第二导杆垂直于超声波探头的超声波阵列声波发生平面。
根据一个实施例，医疗器械试样夹还能围绕第二导杆旋转，以允许调节角度。
根据一个实施例，回声医疗器械回声反射性量化测试系统还包括用于保持测试介质的容器和处于框架正下方的升降台上，容器放在升降台上。
根据一个实施例，框架可以是封闭式框架或开放式框架。
根据一个实施例，超声波探头具有主平面和厚度，超声波探头的超声波阵列声波发生平面为平行于主平面并垂直于厚度，探头的主平面垂直于第一导杆和第二导杆。
根据一个实施例，超声波诊断设备包括分析单元，分析单元配置成：读取回声医疗器械试样或测试介质的感兴趣区域的灰阶平均值，读取与感兴趣区域具有相似像素数的邻近区域的灰阶平均值，并计算感兴趣区域灰阶平均值与邻近区域灰阶平均值之差。
根据一个实施例，分析单元配置成：计算感兴趣区域灰阶平均值与邻近区域灰阶平均值的至少三个差，并对所述至少三个差计算平均值。
附图说明
根据以下参考附图对示例性实施例的描述，本实用新型的其他特征将变得明显。
图1是本实用新型回声反射性量化测试系统的俯视立体图。
图2是本实用新型回声反射性量化测试系统的探头夹的俯视图。
图3是本实用新型回声反射性量化测试系统的医疗器械试样夹具的立体图。
图4是本实用新型回声反射性量化测试系统的俯视立体图。
图5是本实用新型回声反射性量化测试系统的探头夹具的俯视立体图。
图6是本实用新型回声反射性量化测试系统的医疗器械试样夹具的俯视立体图。
图7是本实用新型回声反射性量化测试系统的医疗器械夹具的放大立体图，去除了医疗器械试样。
具体实施方式
在下文中，将参考附图描述根据本实用新型的实施例。回声医疗器械的示例包括用于经皮肾镜手术的医疗器械。例如，回声医疗器械是球囊扩张器(或者说球囊导管)。但是，应当注意，回声医疗器械的示例并不限于此。根据具体应用用途的不同，回声医疗器械可以是本领域技术人员所知的其它医疗器械，例如腹部用医疗器械、妇产科医疗器械、心脏用医疗器械等等。
以下描述的实施例只是作为具体示例。然而，本实用新型不限于说明书中描述的实施例。
回声医疗器械回声反射性量化测试系统主要包括以下方面：用于夹持超声波探头和医疗器械试样的夹具组件；超声波诊断设备；测试介质；像素分析方法。
用于夹持超声波探头和医疗器械试样的夹具组件：
测试系统中夹具组件是很重要的，以便使因医疗器械试样和超声波探头不当夹持所导致的意外差异最小化。如图1所示，夹具组件包括框架。根据一个实施例，框架例如为长方体形。夹具组件还包括：探头夹具1.1，探头夹具具有第一导杆和用于保持超声波探头1.6的探头夹1.2(图2中放大示出)，探头夹1.2可动地保持在第一导杆上；和医疗器械试样夹具，医疗器械试样夹具具有第二导杆和用于夹持医疗器械试样1.7(参见图3、图6)的医疗器械试样夹1.4，医疗器械试样夹1.4可动地保持在第二导杆上。在框架上，设有两个相对的导轨1.3，第一导杆的两端和第二导杆的两端分别可动地设置在导轨中。
如图2所示，探头夹1.2的形状可根据超声波探头1.6的外形来调整，以确保探头夹具1.1能够稳定地夹持超声波探头1.6。
通过使第一导杆和第二导杆在框架的导轨中平移，就可以调节探头夹1.2和医疗器械试样夹1.4之间的相对位置或距离，从而可以调节超声波探头1.6和医疗器械试样1.7之间的相对位置或距离。此外，探头夹具和医疗器械试样夹具之间的距离需要调节到较好地模拟实际应用情况。一种调节方式是：固定探头夹(固定探头1.6)，并通过在第二导杆上沿着方向1.4.1(该方向垂直于探头1.6发生声波的超声波阵列，后面会更详细描述)移动医疗器械试样夹1.4来调节医疗器械试样1.7的位置。其他方式可以是：固定医疗器械试样夹1.4并沿第一导杆移动探头夹1.2；或者是同时沿第一导杆移动探头夹和沿第二导杆移动医疗器械试样夹。
此外，医疗器械试样夹1.4是可旋转调节的，以便能可旋转地调节医疗器械试样1.7。具体地，如图3所示，除了能沿着第二导杆平移以外，医疗器械试样夹1.4还能围绕第二导杆在垂直于方向1.4.1的方向1.4.2上旋转，以允许调节检测角度。例如，在医疗器械试样是球囊扩张器的情况下，通过旋转医疗器械试样夹能够更好地模拟球囊扩张器在实际应用时的穿刺角度。
测试介质以及夹具设定：
回声反射性量化测试系统还可以包括用于保持测试介质的容器1.5。可以用各种不同的测试介质来填充容器1.5。测试介质2.1从统计学角度来说应该是稳定的，接近临床应用环境。可以选择的是模拟的流体、模拟的生物组织或尸体器官。
如图4所示，把测试介质2.1(商业模拟流体)注入到容器1.5中，把容器1.5放在升降台2.2上，并处于框架正下方。替代地，框架本身是封闭式的，这样模拟流体可直接注入到框架内，或者模拟器官也可直接放入框架内，从而不再需要单独的容器。
把超声波探头1.6固定到探头夹1.2上，如图2所示。把探头夹1.2连同超声波探头1.6一起放在探头夹具1.1的第一导杆上，见图1(图5示出的是未放探头夹1.2和超声波探头1.6的探头夹具)。如前所述，探头夹1.2和探头夹具1.1的形状可根据用在特定测试中的超声波探头外形来改变。
利用升降台2.2移动容器1.5，以确保超声波探头1.6和医疗器械试样1.7放在容器内的测试介质液面之下。这样，如果是对测试介质进行回声反射性量化测试的话，那么就能确保测试介质的ROI处于超声波探头的声路(即探头长轴的中心)的正下方。此外，如图2所示，超声波探头1.6为扁平的，具有主平面和厚度。探头1.6的超声波阵列声波发生方向为平行于主平面并垂直于厚度。探头的主平面垂直于测试介质液面，并且垂直于第一导杆和第二导杆。这样，如前所述，探头夹在第一导轨上的平移方向以及医疗器械试样夹在第二导杆上的平移方向都垂直于探头的超声波阵列声波发生方向。
把医疗器械试样1.7夹在医疗器械试样夹1.4上(图3、图6)。如上所述，医疗器械试样夹1.4的设计可以根据医疗器械试样的外形来调整。
在第一导杆上移动探头夹1.2或在第二导杆上移动医疗器械试样夹1.4，以得到二者之间的合适距离，例如约10cm。距离可随测试医疗器械的类型不同而变化。此外，如果是对医疗器械试样进行回声反射性量化测试的话，那么通过在第一导杆上移动探头夹1.2或在第二导杆上移动医疗器械试样夹1.4，就能确保医疗器械试样(及其ROI)与探头发射的超声波阵列处于同一平面中。
此外，如前所述，通过使医疗器械试样夹1.4在垂直于方向1.4.1的方向1.4.2上旋转(如图3所示)，可以把医疗器械试样夹1.4调节一定角度，例如约30°，见图3、图6、图7。角度可随测试医疗器械预期使用类型不同而变化。
超声波诊断设备的设定：
首先，把超声波诊断设备连接到电源。然后，把超声波探头连接到超声波诊断设备，例如把探头信号线插入超声波诊断设备的插口中。接下来，开启超声波诊断设备的开关，并开启超声波诊断设备面板上的开关。
根据本实用新型，例如，如果是对用于经皮肾镜手术的医疗器械(球囊扩张器)进行测试，那么把超声波探头和超声波诊断设备设定为泌尿模式(肾和输尿管)。但是，也可以根据医疗器械预期用途不同来设定其他模式，例如腹部用医疗器械模式、妇产科医疗器械模式、心脏用医疗器械模式等等。同样，具体参数也可以根据医疗器械预期用途不同而设定为其他参数。
接下来，可以对医疗器械试样捕捉图像。
i)把医疗器械试样放在医疗器械试样夹具上。例如，如果是对用于经皮肾镜手术的医疗器械(球囊扩张器)进行测试，那么把未充盈或充气的球囊放在医疗器械试样夹具上，远侧尖端进入测试介质的深度为8cm。深度可根据医疗器械预期用途不同而变化。
ii)在超声波诊断设备中记录医疗器械试样信息。
iii)微调医疗器械试样夹具在水平方向上的位置，以确保球囊尖端、锥形区和球囊主体的一部分在灰阶图像中显示为最亮的影。
iv)捕捉回声球囊的至少三个图像。
v)取出医疗器械试样并清洗。
像素分析(图像分析)：
灰阶图像的量化分析可采用分析单元来进行，该分析单元可以是商业图像处理软件，例如Adobe Photoshop。可以读取ROI中每个像素的灰阶值，并输出灰阶平均值和像素数。也可以输出灰阶中位数，但这在本实用新型中不采用。还应该分析靠近ROI且具有相似像素数的附近区域，以计算ROI相对于附近区域的明度差异(也就是灰阶差异)。
由于临床回声反射性改善应由外科医生在手术过程中肉眼判断，因此回声反射性改善应带来能够由肉眼区分的ROI相对于环境的明度差异。此外，相对于环境(或附近区域)而言，ROI的灰阶绝对值带来的临床好处比归一值要小，因为绝对值会受多个因素的影响。因此，ROI相对于环境的灰阶相对值可用作判断回声反射性的关键参数。
像素分析的一个关键步骤是，需要根据肉眼识别ROI边缘来从整个图像中手动选择ROI。这种主观动作实际上要求与外科医生在手术过程中做的一样，即快速监测医疗器械的位置并相应进行调整。在此过程中，外科医生根据视觉观察医疗器械的明度(即灰阶)来做出快速决定，具体地，根据本实用新型，如果用像素分析来计算的话是用平均值，而非中位数。
像素分析可以包括但不限于以下具体步骤。
1)超声波诊断设备包括分析单元，用分析单元(例如Adobe Photoshop CS5)打开一个图像。
2)把信号通道改变为明度。
3)用快速选择工具选择ROI。
4)读取灰阶平均值，并记录为GS1。
5)用快速选择工具选择ROI的邻近区域，确保选择像素数与步骤3)中的像素数一致。
6)读取步骤5)中选取的邻近区域的灰阶平均值，并记录为GS2。
7)把ROI相对于邻近区域的灰阶相对值定义为RGV＝GS1-GS2。
8)对同一个医疗器械试样需要分析至少三个图像，重复步骤1)-7)。
9)对步骤8)中获得的至少三个RGV计算平均值，作为最终结果。
虽然已经参考示例性实施例描述了本实用新型，但是应当理解本实用新型不限于所公开的示例性实施例。所附权利要求书的范围应当赋予最广义的解释，以便涵盖所有变型以及等同的结构和功能。

Claims (9)

1.一种回声医疗器械回声反射性量化测试系统，包括夹具组件和超声波诊断设备，其特征在于，夹具组件包括：框架；探头夹具，探头夹具具有第一导杆和用于保持超声波探头的探头夹，探头夹可动地保持在第一导杆上，并且超声波探头连接到超声波诊断设备；和医疗器械试样夹具，医疗器械试样夹具具有第二导杆和用于保持医疗器械试样的医疗器械试样夹，医疗器械试样夹可动地保持在第二导杆上；其中，在框架上设有导轨，第一导杆的两端和第二导杆的两端分别可动地设置在导轨中。
2.根据权利要求1所述的回声医疗器械回声反射性量化测试系统，其特征在于，在探头夹在第一导杆上固定不动的情况下，医疗器械试样夹沿第二导杆移动。
3.根据权利要求1所述的回声医疗器械回声反射性量化测试系统，其特征在于，在医疗器械试样夹在第二导杆上固定不动的情况下，探头夹沿第一导杆移动。
4.根据权利要求1所述的回声医疗器械回声反射性量化测试系统，其特征在于，探头夹沿第一导杆移动并同时医疗器械试样夹沿第二导杆移动。
5.根据权利要求1所述的回声医疗器械回声反射性量化测试系统，其特征在于，第二导杆垂直于超声波探头的超声波阵列声波发生平面。
6.根据权利要求1所述的回声医疗器械回声反射性量化测试系统，其特征在于，医疗器械试样夹还能围绕第二导杆旋转，以允许调节角度。
7.根据权利要求1所述的回声医疗器械回声反射性量化测试系统，其特征在于，回声医疗器械回声反射性量化测试系统还包括用于保持测试介质的容器和处于框架正下方的升降台上，容器放在升降台上。
8.根据权利要求1所述的回声医疗器械回声反射性量化测试系统，其特征在于，框架是封闭式框架或开放式框架。
9.根据权利要求1所述的回声医疗器械回声反射性量化测试系统，其特征在于，超声波探头具有主平面和厚度，超声波探头的超声波阵列声波发生平面为平行于主平面并垂直于厚度，探头的主平面垂直于第一导杆和第二导杆。
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