CN103596605A - 带有回声反射覆层的装置 - Google Patents
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Abstract
本发明提供超声成像中显像增强的装置。
Description
相关申请的交叉引用
本申请要求2011年5月6日提交的临时申请序列号61/483,089的优先权。
发明领域
本发明涉及回声反射性增强以在超声成像中更好显像的装置和用于增强装置的回声反射性的方法。
发明背景
超声技术具有优于其它成像形式的优势。除减少或消除暴露至X射线(透视检查)的健康优势之外,所需设备足够小以便移动,并且其在表面下组织形态学诊断中具有优势。此外,可将超声换能器制作得足够小以置入体内,其在体内能提供优于现有的磁共振成像和X光计算机断层成像的分辨率。此外,增加回声反射性以适应超声的介入工具或装置的增强(enhancement)使医师能够快速且适当地治疗患者,节约时间和金钱。
许多介入工具和器械被设计成具有抛光表面,所述抛光表面使所述器械几乎是超声不可见的。介入工具和器械在本文中被称作“装置”。本发明涉及介入装置的增加回声反射性的增强。介入装置包括但不限于,隔膜穿刺针以及可植入装置,例如但不限于,支架、滤器、支架图纹和/或心脏瓣膜。人们已对超声成像装置的增强或“回声反射性”研究多年。当声波接触光滑表面时,入射角和反射角相同。如果目标位于陡角,那么大部分或全部所述声波反射而离开发射/接收源。就这种陡角而言,如果散射不直接返回至来源换能器,那么即使高反射性的装置都可能是超声不可见的。相反地,如果目标是垂直的,那么直接反射回来的声波可导致“白化(white out)”作用,从而阻碍操作者观察该目标。这种影响被称作镜反射。
医疗装置制造者尝试了多种技术以改进装置的超声可视性。示例包括使所述装置表面变粗糙,气体截留,在基材表面黏附颗粒,在基材内制造缺口或空洞以及使用不同材料。
发明内容
本发明的一个方面涉及回声反射增强的介入工具或装置。所述需要由超声显像的介入工具或装置的外表面有熔合聚合物颗粒覆层,所述聚合物颗粒覆层附着在所述工具或装置的至少部分外表面。
本发明的另一个方面涉及通过在介入工具或装置表面附着生物元件来增强所述介入工具或装置的回声反射性的方法。在该实施方式中,所述介入工具或装置可具有附着生物元件的原本光滑的表面;由此增加所述表面的粗糙度和回声反射性。
本发明的另一个方面涉及用于增强介入工具或装置的回声反射性的方法。在该方法中,使熔合聚合物颗粒覆层附着于所述介入工具或装置的至少一部分。
附图说明
图1显示介入工具或装置。
图2显示被覆了熔合聚合物颗粒的图1的相同介入工具或装置。
图3的柱状图显示如图2描述的具有熔合聚合物颗粒覆层(溶剂化聚合物的喷雾覆层)的本发明装置和其它市售可得的经被覆的装置的高于对照的dB增加的比较结果。
图4是以不同角度反射的能量的曲线,其反映增加的回声反射响应。
发明详述
本发明的回声反射增强的装置包括需要由超声成像的装置,所述装置的至少部分外表面附着有熔合聚合物颗粒覆层。
如本发明所述能够让超声成像的可视性增强的介入工具或装置的示例包括但不限于,医疗装置,例如永久植入或暂时留置的装置,例如导管、导线、支架和其它附件及工具、手术器械,以及针,例如隔膜穿刺针。然而,如本领域技术人员在阅读本公开后将会理解的,本文所述的通过超声成像来增强装置可视性的技术适用于多种不同领域和装置。
根据本发明,通过使熔合聚合物颗粒覆层附着在所述装置的至少部分外表面来增强该装置的回声反射性。
在一个实施方式中,所述覆层的熔合聚合物颗粒是至少部分相互连接的。根据所需回声反射增强的程度,可使用较低密集度的聚合物颗粒,使得一些颗粒在附着于所述装置时可以不与一个或多个邻近聚合物颗粒熔合。
在一个实施方式中,所述熔合聚合物颗粒覆层使所述工具或装置的外表面具有无规则表面形貌。用超声查看时,该无规则表面形貌在所述装置上产生独特、可见的特征图。根据终端装置应用,另一个所需实施方式还可包括平坦和/或平滑的凹陷形貌的熔合聚合物颗粒区域。
在一个实施方式中,所述熔合聚合物颗粒覆层的表面粗糙度大于所选超声成像波长的0.5%。例如,以7.5MHz的超声成像的波长是200μm。因此,就此超声波长而言,在该实施方式中,所述熔合聚合物颗粒覆层的表面粗糙度大于1μm(200μm的0.5%)。
所述熔合聚合物颗粒覆层的一个实施方式可包括熔合含氟聚合物颗粒、熔合硅酮颗粒、熔合聚烯烃颗粒等。用于本发明的覆层的熔合含氟聚合物颗粒的示例包括但不限于,氟化乙烯丙烯(FEP)和氟化乙烯丙烯全氟烷基乙烯基醚,或聚四氟乙烯-乙酸乙烯酯无规共聚物。尤为感兴趣的是PTFE颗粒(可将其筛至精确且确定的尺寸)。然后,使所述PTFE颗粒结合于带有FEP或乙烯氟乙烯丙烯(EFEP)的医疗装置或植入物。通过使用相同聚合物的不同熔体流动指数可以实现相同结果。
在一个实施方式中,所述熔合聚合物颗粒覆层的熔融温度低于300℃。在另一个实施方式中,所述熔合聚合物颗粒覆层的熔融温度低于200℃。在又另一个实施方式中,所述熔合聚合物颗粒覆层的熔融温度低于170℃。在又另一个实施方式中,所述熔合聚合物颗粒覆层的熔融温度低于140℃。在其它实施方式中,所述熔合聚合物颗粒具有无确定熔融温度的无定形状态。
本发明的一个重要方面是需要选择聚合物颗粒,所述聚合物颗粒将制成熔合颗粒覆层但对所述需成像的装置的性质和功能无负面影响。
在本发明的另一个实施方式中,通过将生物元件附着至介入工具或装置的表面来增强介入工具或装置的回声反射性。在该实施方式中,所述介入工具或装置可具有附着了生物元件的原本光滑的表面。生物元件包括血细胞、血纤蛋白、血小板等。为促进所述生物元件的附着,所述介入工具或装置可包含表面覆层(例如血纤蛋白或正电荷),所述覆层通过例如但不限于薄聚乙烯亚胺覆层的方式进行。
通过实验证明基于本发明的一个方面的装置的增强的回声反射性。结果于图3描述,其示出基于本发明的一个方面的装置和被覆安捷泰(Angiotech)的装置的高于对照的dB增加的比较。
通过下面所提供的非限制性实施例来进一步阐述本发明。
实施例
实施例1:材料
使用直径0.040"和长度约4.8"尺寸的不锈钢针作为回声反射增强测试物。使用未经修饰的针作为对照以比较修饰结果。还将被覆了熔合聚合物颗粒覆层的不锈钢针的回声反射性与被覆安捷泰的针(安捷泰医药公司(AngiotechPharmaceuticals,Inc.),加拿大不列颠哥伦比亚温哥华,车站街1618号,邮编V6A1B6)的回声反射性做比较。此外,如美国专利7,049,380所述,通过将TFE和PMVE的热塑性共聚物溶解于溶液中来筹备第二实施方式。使用设置成28.2psig气压以形成良好薄雾的喷雾器(空气原子(Air Atom),喷雾系统公司(SpraySystems Co.))以2mL/分钟的速率喷洒该溶液。然后,缓慢旋转光滑的针,并使其前前后后通过该喷雾,总共通过3次。使该溶剂空气干燥。相较于所述基底、即光滑的装置表面而言,该喷雾被覆的装置的形貌有所增加。将所述经被覆的针的回声反射响应在图3和图4中作图,其反映所述经被覆的针的回声反射响应的增加。
实施例2:方法
采用三种不同方法来评价和比较经处理的样品。
将所有样品供于声波成像系统。所述测试设备由被安装在带有样品固定器的扁条上的7.5MHz发射/接收换能器组成,所述样品固定器位于所述换能器焦距的约2.5cm处。该7.5MHz换能器产生200微米的波长(λ)。在2.5cm处,所述信号的宽度约为1mm。将所述针样品置入固定器,所述固定器垂直于所述发射换能器的轴。这是0度。所述样品固定器可移动,以易于更换样品。所述固定器被磁力固定在可旋转装置中,以测量所述样品相对于发射和接收换能器的角度。将所述样品和换能器浸入室温水槽中。在采集数据之前,将各样品与所述换能器对准。这通过增加脉冲发生器/接收器控制器上的衰减设定(约40dB)以防止接收信号的饱和来完成。然后,操作者用眼监视所述波信号,同时手动旋转测角仪,并转动所述换能器上的微调旋钮以达到最大返回信号。调节所述衰减至约1伏特的参考点。记录该衰减设定和测角仪读数。将该测角仪从所述记录读数旋转10度。由于信号通常在垂直(镜面读取)时不减少,所以减小所述衰减。减小的水平允许收集过程中有足够强的信号,但不至接收器饱和。全角旋转所述样品以确保信号没有饱和或者从所述换能器明显移开或大幅移近所述换能器而将所述信号移出数据收集窗(data collection window)。显著时移表明换能器没有与所述样品的中心或枢轴对准。一旦完成所述设定,将所述测角仪移至10度标记,以增量2度进行点采集,直至50度。将设备连接至所述换能器并测试固定测量的反射。软件、Lab View和硬件用于数据收集和后续分析。
在可潜入来自ATS实验室(ATS laboratories)的血液替代物中的硅酮体模(silicone phantom)中进行样品的第二评价,以增加衰减并产生更保真的成像环境。使用6.5mHz换能器超声系统,将所述样品插入所述体模(phantom)中。获取各样品的静止显像。这些显像相较于对照显像而言是可视的,并且用换能器2D数据检查连贯性。在三个不同时间收集数据。在第二收集和第三收集之间,重建所述换能器。因此,当曲线图中绝对dB量不同时,相对Δ是重要的。第三评价是采用光学比较器的表面分析。通过所述仪器软件进一步处理全部原始数据以更好评价所述样品。去除目测倾斜和圆柱曲率。选择高斯滤波器(傅立叶)来过滤低于20-1mm的频率。采用最大3或5像素恢复不完整的内点。遮盖所有样品的边缘以去除与过滤相关的大数据丢失部分和异常。首先处理2D样品,然后处理3D样品。
采用总粗糙度高度Rt或PV(评估长度中表面概况的最大峰谷高度)来表征表面粗糙度。图3中描述熔合颗粒实施方式的装置、被覆SCP的实施方式的装置和被覆安捷泰的装置的高于对照的dB增加的比较。
Claims (14)
1.一种回声反射增强的装置,所述装置包括:
(a)具有外表面的装置;和
(b)附着在所述工具或装置的至少部分外表面的熔合聚合物颗粒涂层。
2.如权利要求1所述的回声反射增强的装置,其特征在于,所述涂层的熔合聚合物颗粒是至少部分相互连接的。
3.如权利要求1所述的回声反射增强的装置,其特征在于,所述熔合聚合物颗粒涂层使所述工具或装置的外表面具有无规则表面形貌。
4.如权利要求1所述的回声反射增强的装置,其特征在于,所述熔合聚合物颗粒涂层的表面粗糙度大于所选超声成像波长的0.5%。
5.如权利要求1所述的回声反射增强的装置,其特征在于,所述熔合聚合物颗粒涂层的表面粗糙度大于1.0μm。
6.如权利要求1所述的回声反射增强的装置,其特征在于,所述熔合聚合物颗粒涂层包含熔合含氟聚合物颗粒。
7.如权利要求6所述的回声反射增强的装置,其特征在于,所述熔合含氟聚合物颗粒包括氟化乙烯丙烯或氟化乙烯丙烯。
8.如权利要求1所述的回声反射增强的装置,其特征在于,所述熔合聚合物颗粒涂层的熔融温度低于300℃。
9.如权利要求1所述的回声反射增强的装置,其特征在于,所述熔合聚合物颗粒涂层的熔融温度低于200℃。
10.如权利要求1所述的回声反射增强的装置,其特征在于,所述熔合聚合物颗粒涂层的熔融温度低于170℃。
11.如权利要求1所述的回声反射增强的装置,其特征在于,所述装置是外科器械。
12.如权利要求1所述的回声反射增强的装置,其特征在于,所述装置是隔膜穿刺针。
13.一种用于增强介入工具或装置的回声反射性的方法,所述方法包括:使聚合物颗粒涂层附着于装置的至少一部分。
14.如权利要求13所述的方法,其特征在于,所述熔合聚合物颗粒涂层包含熔合含氟聚合物颗粒。
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US201161483089P | 2011-05-06 | 2011-05-06 | |
US61/483,089 | 2011-05-06 | ||
PCT/US2012/036751 WO2012154656A1 (en) | 2011-05-06 | 2012-05-07 | Device with echogenic coating |
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US (1) | US20120283763A1 (zh) |
EP (1) | EP2704758A1 (zh) |
KR (1) | KR20140010983A (zh) |
CN (1) | CN103596605A (zh) |
AU (1) | AU2012253737B2 (zh) |
CA (1) | CA2836379A1 (zh) |
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CN106037820A (zh) * | 2015-01-09 | 2016-10-26 | 柯尼卡美能达株式会社 | 超声波诊断装置 |
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RU2763819C1 (ru) * | 2021-06-25 | 2022-01-11 | Разин Мирзекеримович Рагимов | Способ улучшения эхогенных свойств игл для прицельной пункционной и аспирационной биопсии |
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US20120283763A1 (en) | 2012-11-08 |
KR20140010983A (ko) | 2014-01-27 |
RU2013154090A (ru) | 2015-06-20 |
EP2704758A1 (en) | 2014-03-12 |
AU2012253737B2 (en) | 2015-04-30 |
WO2012154656A1 (en) | 2012-11-15 |
CA2836379A1 (en) | 2012-11-15 |
RU2567839C2 (ru) | 2015-11-10 |
AU2012253737A1 (en) | 2013-12-05 |
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