CN101653382A - 活检标记物输送装置 - Google Patents

活检标记物输送装置 Download PDF

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CN101653382A
CN101653382A CN200910167431A CN200910167431A CN101653382A CN 101653382 A CN101653382 A CN 101653382A CN 200910167431 A CN200910167431 A CN 200910167431A CN 200910167431 A CN200910167431 A CN 200910167431A CN 101653382 A CN101653382 A CN 101653382A
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A·P·诺克
R·拉莫斯
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Devicor Medical Products Inc
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Abstract

本发明公开了一种活检标记物输送装置，所述活检标记物输送装置用于将活检标记物输送到活检部位。所述活检装置可以包括在套管远端中设有整体式末段的标记物放置器。所述远侧末段可以为模制部件，该模制部件包括远侧末端、标记物放置倾斜部分和标记物接合件，所述标记物接合件用于辅助将标记物保持在套管内，直到将要放置标记物。

Description

活检标记物输送装置
技术领域
本发明涉及一种活检标记物输送装置。
背景技术
活检样本可以在各种医疗操作中，利用各种装置，通过各种方法取得。俄亥俄州辛辛那提市Ethicon Endo-Surgery，Inc.的
Figure G2009101674316D00011
牌装置是一种示例性活检装置。活检装置的使用可以在立体定向引导装置、超声引导装置、磁共振引导装置等的引导下进行。
更多的示例性的活检装置在下列文献中公开，包括：1996年6月18日公告、题为“Method and Apparatus for Automated Biopsy andCollection of Soft Tissue”的美国专利No.5,526,822；2000年7月11日公告、题为“Control Apparatus for an Automated Surgical BiopsyDevice”的美国专利No.6,086,544；2003年6月12日公布、题为“MRICompatible Surgical Biopsy Device”的美国专利公布No.2003/0109803；2007年5月24日公布、题为“Remote Thumbwheelfor a Surgical Biopsy Device”的美国专利公布No.2007/0118048；2006年12月13日提交、题为“Biopsy System”、序列号为No.60/869,736的美国临时专利申请；2006年12月13日提交、题为“Biopsy SampleStorage”、序列号为No.60/874,792的美国临时专利申请；以及2007年11月21日提交、题为“Revolving Tissue Sample Holder for BiopsyDevice”、序列号为No.11/942,785的美国非临时专利申请。上述各美国专利、美国专利申请公布、美国临时专利申请以及美国非临时专利申请所公开的内容均通过引用包含于此。
在一些情况下，为了后续参照，可能希望把活检部位的位置标记出来。例如可以在从活检部位取出组织样本之前、过程中或者之后将一个或多个标记物放置到所述活检部位处。示例性的标记物放置工具包括俄亥俄州辛辛那提市Ethicon Endo-Surgery，Inc.的和
Figure G2009101674316D00022
牌装置。更多示例性的标记活检部位的装置和方法在以下文献中公开，包括：2005年10月13日公布、题为“Marker Device and Method of Deploying aCavity Marker Using a Surgical Biopsy Device”的美国专利公布No.2005/0228311；2006年2月7日公告、题为“Imageable Biopsy SiteMarker”的美国专利No.6,996,433；2006年1月31日公告、题为“Tissue Site Markers for In Vivo Imaging”的美国专利No.6,993,375；2006年5月16日公告、题为“Tissue Site Markers for In Vivo Imaging”的美国专利No.7,047,063；2007年6月12日公告、题为“Methods forMarking a Biopsy Site”的美国专利No.7,229,417；2006年5月16日公告、题为“Devices for Defining and Marking Tissue”的美国专利No.7,044,957；2001年5月8日公告、题为“Devices for Marking andDefining Particular Locations in Body Tissue”的美国专利No.6,228,055；以及2002年4月16日公告，题为“Subcutaneous CavityMarking Device and Method”的美国专利No.6,371,904。以上所述各美国专利和美国专利申请公布所公开的内容均通过引用包含于此。
可能希望从套管型放置器将标记物放置到活检部位中。标记物不能无意中掉出放置器外，而且放置标记物所需要的力也不能过大。
发明内容
(1).一种活检标记物输送装置，包括：
套管，其具有从套管的近端延伸到套管的远端的内腔和形成于套管的侧壁中且位于套管远端的近侧的标记物出口；
远侧末端，其用于封闭所述套管的远端；
倾斜部分，其邻近所述标记物出口定位；
标记物接合件，其放置于所述套管的内腔中，其中所述标记物接合件的至少一部分放置于所述标记物出口的近端的远侧处；以及
至少一个标记物，其放置于所述套管的内腔中。
(2).如第(1)项所述的装置，其中，所述倾斜部分与所述标记物接合件构成一个整体部件。
(3).如第(1)项所述的装置，其中，所述倾斜部分与所述标记物接合件与所述远侧末端为一个整体。
(4).如第(1)项所述的装置，其中，所述远侧末端、所述倾斜部分和所述标记物接合件构成一个整体部件。
(5).如第(1)项所述的装置，其中，所述远侧末端、所述倾斜部分和所述标记物接合件构成一个整体模制部件。
(6).如第(1)项所述的装置，其中，所述套管包括具有相对柔性的薄壁的管，并且所述标记物接合件包括置于所述内腔中的相对刚性的构件。
(7).如第(1)项所述的装置，其中，所述套管具有壁厚(t)，所述标记物接合件的厚度大于所述套管的壁厚(t)。
(8).如第(1)项所述的装置，其中，所述标记物接合件在其至少一部分轴向长度上包括具有基本均一厚度的阶梯。
(9).如第(8)项所述的装置，其中，所述标记物接合件包括渐缩的近端。
(10).如第(1)项所述的装置，其中，所述远侧末端比所述套管相对地更加不透辐射。
(11).如第(10)项所述的装置，其中，所述远侧末端、所述倾斜部分和所述标记物接合件比所述套管相对地更加不透辐射。
(12).如第(11)项所述的装置，其中，所述远侧末端、所述倾斜部分和所述标记物接合件包括不透辐射的材料。
(13).如第(12)项所述的装置，其中，所述远侧末端、所述倾斜部分和所述标记物接合件为一个含有硫酸钡的整体模制部件。
(14).如第(1)项所述的装置，其中，所述标记物接合件沿着所述内腔的与所述标记物出口大致相对的底壁延伸。
(15).如第(1)项所述的装置，其中，所述标记物接合件被放置于所述套管中用于强化所述套管。
(16).一种活检标记物输送装置，包括：
套管，其具有近端、远端、在近端和远端之间延伸的内腔、和形成在该套管的侧壁中的标记物出口；
整体式末段，其设置于所述套管的远端中并包括：
远侧末端；
倾斜部分，其位于所述远侧末端的近侧并具有从所述标记物出口的远端延伸的斜面；
标记物接合件，其从所述倾斜部分向近侧延伸；
至少一个活检标记物，其设置于所述套管的内腔中。
附图说明
通过参照附图对一些实例的下述描述，相信可以更好地理解本发明。附图中，相同的附图标记表示相同的元件，其中：
图1示出了标记物输送装置的透视图。
图2示出了根据本发明的标记物输送装置的远侧部分的截面图。
图3示出了正在由放置器通过活检针的侧向组织接收口放置、以用来标记活检部位的标记物。
图4示出了大致平面形的钛片，其具有由一狭窄部分隔开的两个相对较大的瓣片或端部，所述钛片可用于形成不透辐射的标记物元件。
图5示出了由图4所示平面片形成三维的标记物元件，如通过将两个瓣片沿如图5中箭头所示的相反的方向扭转而形成。
图6示出了图5所示标记物元件的端视图，在图6中从端部观看时，标记物元件为大致x形构型。
图7示出了在套管远侧开放端中注模成型整体式末段时使用的组件，用于形成根据本发明的一种实施方式的标记物输送装置的远侧末端、倾斜部分和标记物接合件。
具体实施方式
本发明的一些示例的下述描述不应对本发明的范围造成限制。通过示例性示出、设计用于实现本发明最佳模式之一的下述描述，本领域技术人员会更加清楚本发明的其他示例、特征、方面、实施方式以及优点。同时应该意识到，本发明还存在其他不同而又可以想到的方面，这些都在本发明的范围内。因此，附图和说明本质上应该被认为是示例性的，而不是限制性的。
图1示出了标记物输送装置10，其包括细长的外部套管12，该套管12具有形成在套管12的远端附近并位于远端近侧的标记物出口，诸如钡开口14。
套管12的近端可以设有把手16。可以设置一推杆18，且该推杆18在套管12内同轴地延伸，使得推杆18被配置成能够在套管12内移动，以便使一个或多个标记物移动通过侧开口14(见图2)。推杆18在受压缩时可以有足够的刚度，以将标记物从套管12的内腔通过侧开口14推出，但推杆18在弯曲时又要有相当的柔性。在推杆18的近端可以设有柱塞20，用于将推杆18在套管12中向远侧推，从而将标记物放置到套管12外。
使用者可以用两个手指抓住把手16，并用同一只手的大拇指推动柱塞20，这样使用者用一只手就可以操作所述标记物输送装置10。推杆18上还可设有弹簧(未示出)或其他部件，用于将推杆18相对于把手16和套管12向近侧偏压。
图2示出了根据本发明的一种实施方式的标记物输送装置10的远侧部分的截面图。图2示出了布置在套管12的内腔15中的活检标记物300。所述标记物300可以包括：生物可降解或可吸收的主体306，诸如大致圆柱形的胶原蛋白主体；以及设置在主体306内部的或是由主体306携带的、金属的、基本不透辐射的标记物元件310(如虚线所示)。
套管12可以由任何适合的金属或非金属材料制成。在一种实施方式中，套管12是由适合的医疗级塑料或聚合物制成的薄壁中空管形成的。一种适合的材料是热塑性弹性体，例如聚醚嵌段酰胺(PEBA)，如已知的商标名为PEBAX的材料。套管12可以由PEBAX制成，且基本上可透射可见光及X射线。
可以通过将套管12的壁切除一部分，来形成所述侧开口14。侧开口14与套管的内腔15相连通。侧开口14在轴向(与内腔15的轴线平行的方向)上从开口近端14A延伸到开口远端14B，如图2所示。
从套管12的远端延伸的远侧末端22可以如图2所示为圆化的。如图2，本发明的标记物输送装置中，套管12的远端可以由整体式的末段21来进行封闭，末段21在套管12的远端处形成，且一部分末段21延伸至套管的内腔15中。末段21可以为模制或铸造部件，且能够提供一体地形成的末端22、具有斜面212的倾斜部分210、以及标记物接合件240的组合。斜面212辅助将标记物300从内腔15引导通过侧开口14。标记物接合件240辅助将标记物300保持在内腔15中，直到使用者希望放置标记物。
标记物接合件240设置在内腔15中，且其至少一部分位于侧开口14的近端14A的远侧。标记物接合件240可以在开口14的下方沿着套管15的一部分底壁延伸，并且标记物接合件240可被定位成加强套管的形成开口14的部分。例如，通过将标记物接合件240布置在开口14的下方，如图2所示，所述标记物接合件240可以帮助强化套管12的壁被切除以形成开口14的区域。
在图2所示的实施方式中，标记物接合件240从斜面212的最近侧部分开始延伸，且并不延伸到侧开口14的近侧。但是在其他的实施方式中，标记物接合件240的一部分可以延伸到开口14的近侧。
在图2所示的实施方式中，标记物接合件240除了具有楔形的近端242外，其为沿着自身轴向长度具有大致均一的厚度T的阶梯形。所述楔形近端242与内腔15的纵向轴线之间可以形成约45度的内角(即与图2中水平线的内角)，斜面212与所述纵向轴线之间可以形成约30度的内角。
所述厚度T可以比套管12的壁厚度t大，且在一种实施方式中，厚度T至少为厚度t的大约两倍。在一种实施方式中，厚度T可以在约0.018英寸到约0.040英寸之间，并且壁厚度t可以在约0.005英寸到约0.008英寸之间。内腔15的内径可以为约0.120英寸。
在图2所示的实施方式中，标记物接合件240的朝上表面244(朝向开口14的表面)向远侧延伸并与斜面212接触，使得朝上表面244与斜面212之间没有间隔或缝隙。这样的布置有利于降低标记物300在移动经过标记物接合件时被卡在标记物接合件与倾斜部分之间的可能性。
根据本发明的一种实施方式，标记物接合件240、倾斜部分210和/或末端22可以由比套管12的壁相对更加不透辐射的材料制成，或者包括该材料。例如，当标记物接合件240、倾斜部分210和末端22被形成为整体的末段21时，所述末段21可以包含不透辐射的添加物，如硫酸钡。例如，所述末段21可以为PEBAX模制的部件，其中熔化的PEBAX的模制混合物中加入了重量百分比为大约20％的硫酸钡。
相对更加不透辐射的标记物接合件240、倾斜部分210和末端22在用放射成像法来识别这些组件的位置时很有用。而且，在倾斜部分和/或标记物接合件的阶梯部分与开口14相关联地定位的情形中，添加不透辐射材料可以在放置标记物之前、过程中或者之后帮助确定开口的位置，以及标记物300相对于开口的位置。
附图中示出了内腔15中只放有一个标记物的情况。但是，应该理解，在标记物输送装置10中可以设置多个标记物，例如以首尾相连的构型设置。这些标记物可以具有相同的尺寸和形状，或替代地具有不同的尺寸和/或形状。
套管12大致可透射可见光和X射线，末段21大致不透射可见光和X射线。如果需要，可以在液态的模制混合物中加入染料或其它合适的着色剂为末段21上色。例如，可能希望为不同的活检手术提供不同尺寸的标记物(如长度和/或直径)。例如，可能希望在获取相对较大的活检样本时提供较大的标记物，在获取相对较小的活检样本时提供较小的标记物。可以使用多种颜色中的一种给所述末段21染色来指示套管中设置的标记物的尺寸。例如，如果提供三种标记物尺寸，可以给末段21染上三种颜色中的一种以确定设置在特定标记物装置的套管中的标记物的尺寸。所述末段21也可以通过染色来指示所述标记物输送装置将要使用的特定尺寸(直径或长度)的活检针。另外，也可以将多个标记物输送装置包装成套件的形式，套件中包括具有不同尺寸的标记物和相应地染色的末段的标记物输送装置。
如图3，可以使用标记物输送装置10来放置标记物，从而对患者体内的特定部位进行标记。在图3中示出了套管状活检针1000。所示活检针1000具有带穿刺末端1002的封闭远端，和侧向组织接收孔1014。可以通过活检针1000来将标记物放置器10引导至活检部位，所述活检针可以是用于从活检部位收集组织样本的同一根针。活检针1000可以为与单次插入、多样本真空辅助活检装置一起使用的类型。在所引用并通过引用结合入本文的各专利及专利申请中公开了多种此类活检装置，但也可以使用其它的活检装置。
图3中示出了标记物放置器10的远端被设置于活检针1000的内部。活检针1000可以被放置于组织内，通过开口1014可以取得活检样本，因此在开口1014附近处提供活检腔。然后，在组织样本被获取、并通过活检针向近侧移动之后，在保持不将活检针1000从患者组织内拔出的情况下，放置器10可被插入活检针1000中的近侧开口中。在图3中，活检针1000与标记物放置器10的位置被布置成使得套管12的开口14与活检针1000的开口1014在轴向和周向都基本对准。且在标记物放置器与活检针如上述布置在活检部位的情况下，推进推杆18将标记物推上斜面212，通过开口14，然后再通过开口1014，进入活检腔。
图4至图6示出了可与标记物输送装置10一起使用的不透辐射的标记物元件。图4示出了大致平面形状的坯件310A，其由不透辐射材料(如钛)制成，可以通过切割或其他方式形成为包括相对较大的第一部分312、相对较大的第二部分314、以及连接第一部分312和第二部分314的相对较窄的部分316。坯件310A可以包括第一侧315和第二侧317。
所示第一部分312和第二部分314为大致圆形的瓣片，但也可使用其他形状，如正方形、矩形、三角形、卵形。为了形成三维的标记物元件310(诸如如图2所示的可置于生物可吸收的主体306内的标记物元件)，可以将两个瓣片312和314绕轴线318向相反的方向扭转，如图5中箭头所示。可将两个瓣片312和314扭转成二者之间的夹角319(如图6所示)在约45度到约135度之间。这样得到的三维的、不透辐射的标记物元件310当从一端看上去时为大致x形，如图6所示。因为基本为平面的部分312和314被扭转之后互相不在一个平面上，这样在包括X射线的多种成像方法下，它们可以更容易地被从各个方向(如顶面、底面、侧面、端面等)观察到。如图5和图6所示的三维的标记物元件310可以插入生物可吸收的主体306内(如图2)，或者用其他方式由主体306携带，以提供具有生物可吸收主体和不透辐射的标记物元件的标记物300。
图7示出了可用于在套管12的远端中注射模制整体式的末段21的组件。所述组件可以包括具有模腔4020的模具部分4000，所述模腔包括一圆化的表面4021(对应于图2所示圆化的、大致半球形的末端22)。如图7所示，可以将套管12放置于模腔4020内。可以将具有大致圆柱形外表面的模芯部件5000放置于套管12的内腔中，如图7所示。所述部件5000可以具有与斜面212、阶梯面244、以及楔形端面242相对应的端面5212、5244和5242。然后将包括PEBAX和不透辐射的添加物的熔融混合物注入模腔4020，这样末段21就在套管12的远侧开口处形成。
这里公开的装置的实施方式通常是设计为一次性使用的，但也可以设计为多次使用。在形成标记物并将之插入标记物放置器中之后，可以对活检装置进行杀菌处理。装置可以被放置于包装中，如塑料袋或高密度聚乙烯合成纸袋。
然后可以将包装好的活检装置置于辐射场中，如伽马射线、X射线或高能量电子辐射场中，来对装置和包装进行杀菌处理。也可以使用本领域所知的任何其他技术对装置进行杀菌，包括但不限于贝塔或伽马射线、环氧乙烯或蒸汽。
已经阐明和示出了本发明的多种实施方式，在不脱离本发明范围的情况下，本领域的普通技术人员能够通过适当的修改来实现对此处描述的方法和系统的其它变型。文中已经提到过多种这些可能的修改，其它修改对于本领域技术人员来说也是可以想到的。例如，上面详述的实例、实施方式、几何设计、材料、尺寸、比例、步骤等都是示例性的而不是必须的。因此，本发明的范围应该认为由后附的权利要求书来确定，并不应当被理解为限制到说明书和附图中所描述和示出的结构和操作的细节。

Claims (10)

1.一种活检标记物输送装置，包括：
套管，其具有从套管的近端延伸到套管的远端的内腔和形成于套管的侧壁中且位于套管远端的近侧的标记物出口；
远侧末端，其用于封闭所述套管的远端；
倾斜部分，其邻近所述标记物出口定位；
标记物接合件，其放置于所述套管的内腔中，其中所述标记物接合件的至少一部分放置于所述标记物出口的近端的远侧处；以及
至少一个标记物，其放置于所述套管的内腔中。
2.如权利要求1所述的装置，其中，所述倾斜部分与所述标记物接合件构成一个整体部件。
3.如权利要求1所述的装置，其中，所述倾斜部分与所述标记物接合件与所述远侧末端为一个整体。
4.如权利要求1所述的装置，其中，所述远侧末端、所述倾斜部分和所述标记物接合件构成一个整体部件。
5.如权利要求1所述的装置，其中，所述远侧末端、所述倾斜部分和所述标记物接合件构成一个整体模制部件。
6.如权利要求1所述的装置，其中，所述套管包括具有相对柔性的薄壁的管，并且所述标记物接合件包括置于所述内腔中的相对刚性的构件。
7.如权利要求1所述的装置，其中，所述套管具有壁厚(t)，所述标记物接合件的厚度大于所述套管的壁厚(t)。
8.如权利要求1所述的装置，其中，所述标记物接合件在其至少一部分轴向长度上包括具有基本均一厚度的阶梯。
9.如权利要求8所述的装置，其中，所述标记物接合件包括楔形的近端。
10.如权利要求1所述的装置，其中，所述远侧末端比所述套管相对更加不透辐射。
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