CN103596506B - 回声反射套筒 - Google Patents
回声反射套筒 Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
- A61B8/0833—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
- A61B8/0841—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures for locating instruments
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3403—Needle locating or guiding means
- A61B2017/3413—Needle locating or guiding means guided by ultrasound
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, 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
- A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
- A61B2090/3925—Markers, e.g. radio-opaque or breast lesions markers ultrasonic
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M25/0108—Steering means as part of the catheter or advancing means; Markers for positioning using radio-opaque or ultrasound markers
Abstract
本发明提供超声成像中显像增强的装置。一种回声反射增强的介入装置,所述介入装置包括:需由超声成像的介入装置;和回声反射聚合物套筒,该回声反射聚合物套筒具有可调节形貌且被设置得邻近于所述介入装置。
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61/483,098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在手推车上移动。其还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,其在体内可提供的分辨率优于采用外部超声成像、磁共振成像和X光计算机断层成像的当前可达的分辨率。此外,增加超声成像下的回声反射性的器械增强(enhancement)使医师能够快速且更适当地治疗患者,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。
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(whiteout)”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器械,其包括需由超声成像的介入工具或器械,以及回声反射聚合物套筒,所述回声反射聚合物套筒具有可调节形貌且被设置得邻近于所述介入工具或器械。在一个实施方式中,所述回声反射聚合物套筒包围所述介入工具或器械的至少一部分。所述聚合物套筒可附着在所述介入工具或器械的至少一个位置上。提供调节手段,从而可在使用所述介入工具或器械时改变该聚合物套筒的形貌。
本发明的另一个方面涉及用于增强介入工具或器械的回声反射性的方法。在该方法中,将具有可调节形貌的回声反射聚合物套筒设置得邻近于所述介入工具或器械。在一个实施方式中,设置所述回声反射聚合物套筒使之包围所述介入工具或器械的至少一部分。该方法提供调节手段,从而可在使用所述介入工具或器械时改变该聚合物套筒的形貌。
在另一个实施方式中,提供可滑动到介入工具或器械上或可环绕介入工具或器械滑动的聚合物套筒,并随后固定至所述介入工具或器械的至少一部分。提供调节手段,从而可在使用所述介入工具或器械时改变该聚合物套筒的形貌。
附图说明
图1显示带有回声反射聚合物套筒的介入工具或器械,所述回声反射聚合物套筒具有可调节形貌且被设置得邻近于所述器械。
图2显示相同的介入工具或器械,其中,已通过缩短所述套筒相对于所述介入工具或器械的长度来调节所述聚合物套筒的形貌,由此增加其回声反射性。
图3的柱状图显示如图2描述的带有缩短的聚合物套筒的本发明器械和其它市售可得的经被覆的器械的高于对照的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介入工具或装置包括需由超声成像的介入工具或装置,以及回声反射聚合物套筒,所述回声反射聚合物套筒具有可调节形貌且被设置得邻近于所述介入装置。
如本发明所述能够让超声成像的可视性增强的介入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,和手术器械,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介入装置可视性的技术适用于多种不同领域和装置。
在本发明的一个实施方式中,所述介入装置可以是无法通过超声检测其本身的。例如,所述介入装置可具有在超声成像下使所述装置基本不可见的抛光表面。
在另一个实施方式中,所述介入装置可以具有回声反射性。在本发明的该实施方式中,所述介入装置的回声反射响应可和与之邻近的聚合物套筒的回声反射响应相似或不同。
根据本发明,通过将具有可调节形貌的回声反射聚合物套筒设置得邻近于所述介入装置来增强该介入装置的回声反射性。
在一个实施方式中,所述回声反射聚合物套筒包围所述介入装置的至少一部分。所述聚合物套筒包围所述介入装置的程度部分地取决于该聚合物套筒固定至该装置的方式和该套筒在该装置上相对于所述超声成像源的方向。
由使用者通过调节所述聚合物套筒的形貌来灵活引发或改变本发明装置的回声反射响应。在一个实施方式中,通过改变所述聚合物套筒相对于所述介入装置的长度来调节所述聚合物套筒的形貌。例如,在一个实施方式中,如图1和图2所描述,缩短所述回声反射聚合物套筒相对于所述装置的长度,由此导致所述套筒聚成一束。该聚束导致起皱,其造成回声反射性的增加。在另一个实施方式中,可增加所述聚束的回声反射聚合物套筒相对于所述介入装置的长度以减少形貌,并由此减少回声反射性。本发明的聚合物套筒的形貌改变可以是可逆的或不可逆的。
在另一个实施方式中,可通过引入液体来调节所述套筒的形貌,以赋予回声反射性的改变。在另一个实施方式中,可调节所述套筒材料的外表密度,例如通过会赋予回声反射性的改变的方式引入液体来调节;例如,如果所述材料是多孔性的,且圈闭的空气被液体替代,那么回声反射响应将会改变。回声反射性的调节还可由所述材料的厚度变化造成。所述厚度变化可归因于机械形变,例如但不限于,扭曲该材料以施加减小厚度的应力,或沿轴牵拉所述材料,由此使所述材料聚束以增加厚度。所述压缩可由绕旋转轴旋转或缠绕柔顺性多孔材料造成。本文所用的柔顺性指能够被外力压缩和/或膨胀的任何材料,例如PATT泡沫、硅酮泡沫以及泡沫状的含氟聚合物和氟橡胶。
可使用以最小性能影响获得回声反射响应的任何生物相容的聚合物网材或薄膜。可用于本发明套筒的聚合物的示例包括但不限于:膨胀聚四氟乙烯(ePTFE)、柔顺性聚合物泡沫、多孔性含氟聚合物、PET、聚氨酯、Pebax及其复合物。用于本发明套筒的市售可得的聚合网材包括戈尔公司(Gore)的DUALMESH。
在一个实施方式中,所述薄膜包含很薄的生物相容的膜或薄膜,所述膜或薄膜能以允许沿着介入装置的轴移动的方式形成管形或缠绕在该装置上。所述材料必须如此进行选择:当沿轴压缩(或允许沿轴压缩)时,该材料的起皱必须变得超声可见。
通过实验证明本发明的装置的增强的回声反射性。结果于图3描述,其示出本发明实施方式的高于对照装置的dB增加与被覆安捷泰(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装置。使用未经修饰的针作为对照装置以比较修饰结果。还将如本发明所述的由具有可调节形貌的聚合物套筒包围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。
实施例2:方法
采用三种不同方法来评价和比较实施例和对照装置。
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测角仪中,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。在收集数据之前,将每各样品对准使各样品设置在距离所述换能器相同距离并取向所述换能器处。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。然后,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(datacollectionwindow)。监测时移。显著时移可能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。LabView软件和硬件用于数据收集和后续分析。
在可潜入来自ATS实验室(ATSlaboratories)的血液替代物中的硅酮体模(siliconephantom)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。
图3中描述本发明装置和被覆安捷泰的装置的高于对照的dB增加的比较。
Claims (16)
1.一种回声反射增强的介入装置,所述回声反射增强的介入装置包括:
(a)需由超声成像的介入装置;和
(b)回声反射聚合物套筒,该回声反射聚合物套筒包含生物相容的薄膜,所述薄膜能以允许沿着需由超声成像的介入装置的轴移动的方式缠绕在需由超声成像的介入装置上,当沿轴压缩时,在生物相容的薄膜内形成超声可见的起皱;
所述聚合物套筒的形貌通过改变所述聚合物套筒相对于所述需由超声成像的介入装置的长度来调节。
2.如权利要求1所述的回声反射增强的介入装置,其特征在于,所述回声聚合物套筒包围所述需由超声成像的介入装置的至少一部分。
3.如权利要求1所述的回声反射增强的介入装置,其特征在于,所述聚合物套筒的形貌通过改变所述聚合物套筒相对于所述需由超声成像的介入装置的长度来调节。
4.如权利要求3所述的回声反射增强的介入装置,其特征在于,所述回声反射聚合物套筒的长度被缩短。
5.如权利要求3所述的回声反射增强的介入装置,其特征在于,所述回声反射聚合物套筒的长度被延长。
6.如权利要求3所述的回声反射增强的介入装置,其特征在于,所述通过改变所述聚合物套筒相对于所述需由超声成像的介入装置的长度的调节是可逆的。
7.如权利要求3所述的回声反射增强的介入装置,其特征在于,所述通过改变所述聚合物套筒相对于所述需由超声成像的介入装置的长度的调节是不可逆的。
8.如权利要求1所述的回声反射增强的介入装置,其特征在于,所述回声反射增强的介入装置是外科器械。
9.如权利要求1所述的回声反射增强的介入装置,其特征在于,所述回声反射增强的介入装置是隔膜穿刺针。
10.如权利要求1所述的回声反射增强的介入装置,其特征在于,所述需由超声成像的介入装置不是回声反射性的。
11.如权利要求1所述的回声反射增强的介入装置,其特征在于,所述需由超声成像的介入装置是回声反射性的。
12.如权利要求11所述的回声反射增强的介入装置,其特征在于,所述需由超声成像的介入装置的回声反射响应与所述聚合物套筒不同。
13.如权利要求1所述的回声反射增强的介入装置,其特征在于,所述聚合物套筒包含膨胀聚四氟乙烯(ePTFE)。
14.一种用于增强介入装置的回声反射性的方法,所述方法包括
将生物相容的薄膜以允许沿着介入装置的轴移动的方式缠绕在该装置上,
沿轴压缩聚合物套筒,以改变所述聚合物套筒相对于所述介入装置的长度,并在生物相容的薄膜内形成超声可见的起皱。
15.如权利要求14所述的方法,其特征在于,所述聚合物套筒包围所述介入装置的至少一部分。
16.一种回声反射增强的介入装置,所述回声反射增强的介入装置包括:
(a)需由超声成像的介入装置;和
(b)回声反射聚合物套筒,该回声反射聚合物套筒包含生物相容的薄膜,所述薄膜能以允许沿着需由超声成像的介入装置的轴移动的方式缠绕在该装置上,
所述聚合物套筒的形貌通过改变所述聚合物套筒相对于所述需由超声成像的介入装置的厚度来调节;
其中沿轴压缩在生物相容的薄膜内形成超声可变的起皱。
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US201161483098P | 2011-05-06 | 2011-05-06 | |
US61/483,098 | 2011-05-06 | ||
PCT/US2012/036763 WO2012154667A1 (en) | 2011-05-06 | 2012-05-07 | Echogenic sleeve |
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CN103596506A CN103596506A (zh) | 2014-02-19 |
CN103596506B true CN103596506B (zh) | 2016-03-09 |
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US (1) | US20120283775A1 (zh) |
EP (2) | EP2848202A1 (zh) |
KR (1) | KR20140008446A (zh) |
CN (1) | CN103596506B (zh) |
AU (1) | AU2012253748B2 (zh) |
CA (1) | CA2836412A1 (zh) |
ES (1) | ES2549215T3 (zh) |
HK (2) | HK1196237A1 (zh) |
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- 2012-05-07 CN CN201280028507.7A patent/CN103596506B/zh not_active Expired - Fee Related
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AU2012253748A1 (en) | 2013-12-05 |
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RU2556570C1 (ru) | 2015-07-10 |
EP2709532B1 (en) | 2015-08-12 |
HK1196237A1 (zh) | 2014-12-12 |
AU2012253748B2 (en) | 2015-07-30 |
US20120283775A1 (en) | 2012-11-08 |
CA2836412A1 (en) | 2012-11-15 |
ES2549215T3 (es) | 2015-10-26 |
WO2012154667A1 (en) | 2012-11-15 |
EP2709532A1 (en) | 2014-03-26 |
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KR20140008446A (ko) | 2014-01-21 |
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