CN102802539B - 密封装置和输送系统 - Google Patents

密封装置和输送系统 Download PDF

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CN102802539B
CN102802539B CN201080028772.6A CN201080028772A CN102802539B CN 102802539 B CN102802539 B CN 102802539B CN 201080028772 A CN201080028772 A CN 201080028772A CN 102802539 B CN102802539 B CN 102802539B
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CN102802539A (zh
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B·A·澳瑞利
S·J·马斯特斯
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WL Gore and Associates Inc
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Abstract

本发明涉及一种用于修复心脏和血管缺损或诸如卵圆孔未闭(PFO)的组织开口或心脏、血管系统等内分流的密封装置，并尤其是提供一种封堵器装置和输导管封堵输送系统。这种密封装置将具有对于心脏解剖学的改进顺应性并易于在开口位置处部署、重新定位和取回。密封装置包括可膨胀框(200)，该可膨胀框由从框(200)的远端延伸到近端的多根镍钛诺线，其中镍钛诺包括重量百分比为10％的铂并且是拉填型镍钛诺。线形成近侧孔眼(202)、中间孔眼(203)和远侧孔眼(204)。密封装置还包括密封构件(508)，该密封构件至少部分地包封可膨胀线框。密封构件是通过FEP粘合剂粘附到框的ePTFE的薄材料。

Description

密封装置和输送系统
相关申请的交叉引用
本申请要求2009年6月22日提交的美国临时专利申请USSN61/219,120号的优先权。
发明背景
技术领域
本发明涉及一种用于修复心脏和血管缺损或诸如卵圆孔未闭(PFO)的组织开口或心脏、血管系统等内分流的密封装置，并尤其是提供一种封堵器装置和输导管封堵输送系统。
背景技术
密封装置可用于封堵许多类型的组织开口，诸如间隔缺损、PFO等。
组织开口通常通过心内直视手术来修正。为了避免与心内直视手术相关联的创伤和并发症，已实施了多种输导管闭合技术。在这种技术中，封堵器装置通过导管传递到开口或缺损的位置。装置被放置到缺损中并永久地部署在此。
已知多种输导管输送装置。这些都包括需要装置来在组织开口的位置处组装或者需要螺旋连接或“扣上”分离的装置元件。其它装置是自膨胀式装置。这些自膨胀式装置往往难以看到，装载起来麻烦，难以定位和重新定位在组织开口处。大多数的自膨胀式装置不符合心脏解剖学，从而导致组织侵蚀。
自膨胀式装置的例子包括封堵袋、第三管、引导导管、超弹性线、释放机构和输送套。超弹性线附连于释放机构，而线、释放机构、封堵袋、引导导管和第三管被插入输送套以运输到孔。在输送之后，封堵袋被置于孔内，而线部署在袋内。袋和线如有必要被重新定位，而释放机构被致动以释放线。
自膨胀式装置的另一个例子包括定形管状金属织物装置和可选地包含在该装置的中空部分内的封堵纤维。金属织物形成钟形的医疗装置，其可溃塌以通过导管而部署在病人人体的通道内。
尽管为输送输导管而设计了这些和其它自膨胀式装置，但它们需要在使用之前或在使用时组装。它们一旦被部署也是难以重新定位或取回，并且与心脏解剖学相符性差。为此，可期望提供一种在输导管技术中使用的改进的密封装置。这种密封装置将较佳地具有对于心脏解剖学的改进顺应性并易于在开口位置处部署、重新定位和取回。
输导管自膨胀式密封装置可通过多种措施输送和部署。大多数输导管输送装置选择用于部署装置的两种基本系统中的一种：将外导管向后拉回以释放该装置，或者用推杆来推动该装置使其不在导管内。这些系统中的每个系统利用手柄来致动用于部署装置的机构。这种系统的例子包括用于推动密封装置经过导管的挠性推动构件和用于使推动构件前进的位于远处的控制装置。在此例中，控制装置包括连接到推动构件的带螺纹的管状轴和安装到轴上的可手动转动的带螺纹转子。转子上的螺纹与轴上的螺纹匹配，因而，转子转过已知角度将使轴和推动构件前进已知距离。
利用向后拉回的外轴或导管的系统的例子包括手柄，该手柄在装置的部署和定位过程中可有选择地使输送系统部件保持处于任何构造。这种系统的外导管将被向后拉回，以通过致动滑动杆和输送系统手柄上的转动指环来释放装置。
尽管这些和其它装置输送系统是为输导管的部署而设计的，但它们需要使用带螺纹的转子，这会变得难以转动，或者它们需要较大的力来向后拉回外导管以露出受到限制的装置的整个长度。一旦部署程序已发生，大多数的部署系统不可逆或难以反向。为此，可期望的是提供一种用于密封装置的改进的输送系统。这种输送系统将较佳地具有能够仅用一只手来操作的手柄并将能够用最小的力或手的动作来执行多个操作。
发明内容
第一实施例提供一种具有可膨胀框的密封装置，该可膨胀框由从框的近端延伸到远端多根线构成，而线形成近端孔眼和远端孔眼，该密封构件至少部分地包封可膨胀的线框。
另一实施例提供用于使密封装置部署的手柄和直线致动器，手柄具有外壳，该外壳具有带有一长度的槽，而直线致动器位于槽内并且通过使致动器沿槽长度前进和后退而能够使至少三个单独部件前进和后退。
另一实施例提供一种装置，该装置包括手柄和直线致动器，该手柄具有带有一长度的槽，而直线致动器位于槽内并且通过使致动器沿槽长度前进和后退而能够使至少三个单独部件独立地前进和后退。该装置还包括具有可膨胀框的密封装置，该可膨胀框由从其近端延伸到远端的多根线构成，线形成近侧孔眼和远侧孔眼，密封构件至少部分地包封可膨胀线框。
本发明的附加特征和优点将在说明书中阐述或可通过本发明的操作来了解。通过其书面描述和其权利要求书以及附图中具体指出的结构将实现和得到本发明的这些特征和其它优点。
应当理解，前述总体说明和以下详细说明都是示例性和解释性的，只是对如所要求的本发明作进一步的解释。
附图说明
本说明书附图提供对本发明的进一步理解并被包含到本说明书中且构成其一部分，并且示出本发明的实施方式而与说明书描述一起可用于解释本发明的原理。
附图中：
图1是已部署的密封装置的立体图，该密封装置附连于输送系统的远端。
图2A是密封装置的已膨胀框的视图。
图2B是密封装置的孔眼的端视图。
图2C是密封装置的框的端视图。
图3A-B是卷绕夹具的部件的视图。
图4A是卷绕夹具的侧视图。
图4B是卷绕夹具的俯视图。
图5A是已膨胀的、被覆盖的密封装置的侧视图。
图5B是已膨胀的、被局部覆盖的密封装置的侧视图。
图6是密封装置的自对中实施例的侧视图。
图7是已部署的密封装置的侧视图。
图8是包括部署手柄和已附连的密封装置的输送系统的立体图。
图9A-D是描述输送系统的操作的流程图。
图10是密封装置部署手柄的立体图。
图11是密封装置部署手柄的组件的立体图。
图12A是第一直线致动器的实施例的俯视图。
图12B是第一直线致动器的实施例的侧视图。
图12C是第一直线致动器的实施例的侧视图。
图12D是第一直线致动器的实施例的侧视图。
图13A是锁定释放致动器的实施例的立体图。
图13B是处于致动位置的锁定释放致动器的实施例的立体图。
图14A是弹簧的实施例的立体图。
图14B是第一直线致动器的实施例的端视图。
图15是具有模制弹簧部件的第一直线致动器的实施例的端视图。
图16是弹簧部件的立体图。
具体实施方式
第一实施例提供一种包括具有可膨胀框的密封装置，可膨胀框由从框的近端延伸到远端的多根线构成，这些线形成近侧和远侧孔眼，该密封构件至少部分地包封可膨胀的线框。
图1示出密封装置100的一个实施例。在稍后的部分中将详细讨论密封装置100。密封装置100可容纳于第三管104内。第三管104包含密封装置100、第一管102、第二管108、收回绳110和锁定环111。第三管104可由Pebax或具有合适的生物相容性和机械特性的任何其它材料制成。具有放射不透性的材料选择也可以是一种选项。第三管104可用或不用增强编织物来制造，以提供对于所选择的应用合适的抗弯性和强度。第三管104还可设计有或没有不透辐射的标志带。可为了诸如抗扭性、可操纵性和血管创伤减小的其它特性来选择第三管104的设计和材料。本领域技术人员可易于理解到有各种可用于促进本发明的潜在材料。第三管104可呈任何尺寸，但较佳为10fr.(弗伦奇)，其中内径为约0.048毫米，外径为约0.33毫米。第三管104可与或不与引导线一起使用并可包括快速互换端口103。第三管104的梢端较佳地弯曲成有助于引导和输送密封装置100从进入位置到缺损处，且具有或不具有引导线。
在图1中还示出第一管102。如前所述，第一管102可容纳于第三管104内。第一管102可以具有任何外径尺寸，但其尺寸较佳地配合到第三管104的内腔中。第一管102可由Pebax或具有合适的生物相容性和机械特性的任何其它材料制成。第一管102较佳地是三腔导管。内腔可以呈任何几何形状，但较佳地是圆形或椭圆形或两者的组合。第一管102可用于定位密封装置100并有助于使其部署。第一管102可与第二管108结合使用，以致使密封装置100一旦到达缺损位置就从第三管104的远侧梢端突出。第一管102还可具有使密封装置100保持到输送系统上直至最终装置被部署的功能。第一管102在最远端处具有开口109以允许锁定环111在装置部署过程中突出。开口109和突出的锁定环111提供至装置输送系统的附连。锁定环111在保持其预设定的形状之前以其伸出位置示出。第一管102可被表面处理或涂敷以增强材料的生物相容性或改变或加强表面摩擦。
第一管102可容纳第二管108。第二管108基本上呈带有椭圆形横截面的管状并可具有适于装配到第一管102内的外径。较佳的外径范围将从约1.27x0.68毫米起并将在远端处扩开。第二管108可由包括聚合物或金属在内的任何合适的生物相容的材料制成。较佳的材料将是PEEK(聚醚醚酮)。第二管108可用于促进使密封元件100输送和部署到缺损位置。第二管108穿过密封装置100的孔眼以将密封装置100保持在输送系统上并在部署密封装置100时提供稳定性。将进一步讨论密封装置的孔眼。
收回绳110环绕过第一管102的较小内腔中的两个并且环绕过密封装置100的近侧孔眼，以提供至输送系统的附连以及一旦密封装置被部署的收回方法。
收回绳110延伸经过第一管102的长度，而端部终止于用于部署密封装置100的手柄处。
收回绳110可由具有足够强度和尺寸的任何生物相容的材料制成。较佳的材料是ePTFE(膨胀型聚四氟乙烯)。
如图2A中所示，密封装置100由线框200构成。当为了输送而定位时，线框200处于在第二管108上和第三管104内的伸出位置。线框200可以呈对于应用合适的任何尺寸，但其尺寸较佳为制成的外径为15、20、25或30毫米。线框200由连续线构成。任何数目的线可用于构造线框200。较佳的线数为五。线框200可由具有弹性的线构成，这种弹性允许线框200溃塌以基于导管输送或胸腹内视镜输送，并且一旦定位在缺损内就自膨胀成“记忆”产生构造。弹性线可以是弹簧线，或形状记忆NiTi(镍钛诺)合金线或超弹性NiTi合金线。弹性线还可以是在芯部包含不同金属的拉填型NiTi。较佳地，线框200可由在芯部处包含不透辐射的金属的拉填型NiTi线构成。当部署时，线的结构呈现其部署的形状，而不永久变形。
线框200和所示其它线框由具有0.12与0.4毫米之间外径的弹性线材料构成。在较佳的实施例中，线的外径为约0.3毫米。当形成时，线框200包括远侧突起(bumper)208、远侧孔眼204、锁定环206、可选的中心孔眼203和近侧孔眼202。图2B示出在线框200的孔眼202、203和204的形成过程中弹性线的位置。
图2C示出当线框200部署时所形成的盘状物。形成线框200的弹性线在部署过程中形成瓣状部212。线框200的预设定的弹性线构造允许框在部署过程中扭转。这种扭转形成瓣状部212。部署好的瓣状部212形成线框200的外径214。部署好的瓣状部212在用密封构件106覆盖时形成近侧盘状物和远侧盘状物，这将对此作进一步讨论。瓣状部212最佳地形成为具有重叠区216以提高密封质量。瓣状部212的半径可最大化以将弹性线内的尖锐弯角减到最少并使瓣状部212的未支承部分最小化，瓣状部改进装置的密封质量、减小线内的挠曲疲劳并有助于减小装置的装载力。部署好的瓣状部212在中心孔眼203的任一侧上形成盘状物。将进一步讨论部署的构造。
线框200的构造可通过包括借助于自动线张紧的机器卷绕或在构造过程中用从每根线悬下的配重来手动卷绕的多种手段来实现。在图3A-C中示出键入的中心销300和按钮304，其可用于有利于构造线框200。本领域普通技术人员应认识到有许多适合用作制造辅助件或工具的材料。在形成中心销300时所用的较佳材料将是含钴高强度钢。在形成按钮304和卷绕夹具时所用的较佳材料将是耐腐蚀工具钢。将进一步讨论卷绕夹具。如在图3A中详细示出，键入的中心销300可具有凹槽302，凹槽可用于在装置构造过程中固定弹性线。键入的中心销300可用于引导弹性线穿过按钮304内的开口306，其特征在图3B-3C中示出。按钮304较佳地在其底部形成有凹陷部308以牢固地装配到卷绕夹具中。保持在凹槽302内并被插入穿过按钮304内的开口306的弹性线可形成突起208和锁定环206。键入的中心销300也用于形成孔眼202、203和204。在装置构造过程中，在形成突起208之后，弹性线可围绕键入的中心销300卷绕以形成远侧孔眼202。可以类似的方式形成其它孔眼203和204。一旦键入的中心销300被插入按钮304，弹性线可被插入卷绕夹具内的凹槽中。
卷绕夹具可用于在密封装置100的构造和处理过程中固定和形成弹性线。典型的卷绕夹具可如现有技术中通常已知那样来构造。前面已讨论用于构造这种卷绕夹具的材料。在图4A和4B中示出较佳的卷绕夹具。图4A示出卷绕夹具400的侧视图。图4B示出较佳的卷绕夹具400的顶部视图。卷绕夹具400包含孔402，该孔可成形为和尺寸设计为在装置构造过程中保持键入的中心销300和按钮304。夹具表面内的凹槽404用于将弹性线固定和成形到瓣状部212中。凹槽404可呈任何直径，但其尺寸较佳地设计成容纳弹性线的外径。在图5A中所示的一个实施例中，卷绕夹具组件可用于形成中心孔眼203、瓣状部组件和近侧孔眼204。成形的线可限制于卷绕夹具组件内、被加热并处理成如现有技术中通常已知的那样定形。
图5A示出密封装置100是线框200和密封构件106的复合组件的实施例。密封构件106可通过粘合剂附连于线框200。线框200可涂敷有粘合剂，例如是氟化的乙烯丙烯共聚物(FEP)或其它合适的粘合剂。粘合剂可通过接触涂敷、粉末涂敷、浸渍涂敷、溅射涂敷或任何其它合适的手段来施加。在较佳的实施例中，FEP粘合剂通过静电粉末涂敷来施加。密封构件106可由多种材料构成，诸如DACRON聚酯、聚乙烯、聚丙烯、含氟聚合物、聚氨酯、泡沫薄膜、硅树脂、尼龙、线绸、超弹性材料的薄片、织物材料、聚对苯二甲酸乙二酯(PET)、胶原质、心包膜组织或任何其它生物相容的材料。在一个实施例，密封构件106可由多孔ePTFE(膨胀型聚四氟乙烯)薄基材构成。密封构件106设计成通过提供缺损封堵和用于细胞生长的介质来加强密封装置100的缺损闭合特点。
近侧、远侧和中心孔眼(202，203和204)还在图5A中示出并分别用密封构件106来覆盖并用薄膜来裹绕。孔眼202、203和204可用薄膜来裹绕以促进密封构件106附连至装置。用于包裹孔眼202、203和204的薄膜可以是任何生物相容的薄材料，但材料较佳地由可层叠有一层或多层无孔FEP的多孔薄ePTFE的多层构成。
图5B示出包括局部覆盖线框200的密封构件508的密封装置100的实施例。被局部覆盖的装置可用密封构件508来部分地或整体覆盖远侧或近侧的球形物。
该装置的另一实施例是自对中装置600。图6中示出的自对中装置600包括类似于线框200的线框602。自对中装置600是线框602和密封构件604的复合组件。线框602可用与线框200相同的技术和材料来构造，但不具有中心孔眼。线框602包括远侧突起606、被覆盖的远侧孔眼608、被覆盖的近侧孔眼610和锁定环612。线框602的预设定的弹性线构造允许框在部署时扭转并在部署过程中产生装置600的对中区域614。在部署过程中，区域614可在缺损内自对中，从而形成由区域614和缺损的任一侧上的瓣状部构成的盘状物。
图7示出完全部署好的密封装置100。在部署过程中，第三管104的限制件从装置100中移除，且该装置返回到其预设定的形状。在部署和锁定过程中，锁定环111从第一管102的限制件中释放并返回到其预设定的形状、从而从近侧孔眼202卷曲。这样，该装置被锁定在部署好的状态。图7还示出近侧盘状物和远侧盘状物，即元件702和704分别相对于近侧、中心和远侧孔眼202、203和204的位置。
图8示出附连于输送系统的密封装置100的立体图，该输送系统包括第一管102、第三管104和用于部署密封装置100的手柄。图8还示出第一直线致动器802、冲洗端口804、第二直线致动器806、锁定释放致动器808、外壳810和具有在外壳812内一长度的槽。第一直线致动器802可具有将进一步讨论的多种构造。
图9A-D是描述在使用时输送系统的各种部件和附连的密封装置100的运动的流程图。在图9A中描述在使用前将密封装置100装载到输送系统中。在图8、10和11中示出输送系统手柄的各部件。临床医师可通过将注射器或其它合适的器具附连到冲洗端口804上并用盐水或任何其它合适的冲洗材料注入系统来冲洗输送系统。然后，第一直线致动器802可在外壳810中的槽812内抵抗弹簧1100运动。弹簧1100可如所示构造或可形成为板簧、异径弹簧(steppedspring)或在现有技术中通常已知的任何形式。这种动作使图11中所示的主轴控制杆1000围绕滑动杆1102转动到外壳810那侧。该运动使第一直线致动器802运动到不在镶条(sizinginsert)1103内的远侧凹口1104之内并防止第二管108沿近侧或远侧平移。镶条1103可以是具有合适的机械特性的任何材料。
用于输送医疗装置的典型的手柄、手柄部件、工具或导管可包括通常已知的材料，诸如无定形商用热塑性塑料，其包括聚甲基丙烯酸甲脂(PMMA或丙烯酸)、聚苯乙烯(PS)、丙烯腈-丁二烯-苯乙烯(ABS)、聚氯乙烯(PVC)、改性的聚对苯二甲酸乙二醇酯(PETG)、醋酸丁酸纤维素(CAB)；半晶态商用塑料，其包括聚乙烯(PE)、高密度聚乙烯(HDPE)、低密度聚乙烯(LDPE或LLDPE)、聚丙烯(PP)、聚甲基戊烯(PMP)；无定形工程热塑性塑料，其包括聚碳酸酯(PC)、聚苯醚(PPO)、改性的聚苯醚(ModPPO)、聚丙乙烯(PPE)、改性的聚丙乙烯(ModPPE)、热塑性聚氨酯(TPU)；半晶态工程热塑性塑料，其包括聚酰胺(PA或尼龙)、聚甲醛(POM或缩醛)、聚对苯二甲酸乙二酯(PET，热塑性聚酯)、聚对苯二甲酸丁二酯(PBT，热塑性聚酯)、超高分子量聚乙烯(UHMW-PE)；高性能热塑性塑料，其包括聚酰亚胺(PI，酰亚胺化塑料)、聚酰胺-酰亚胺(PAI，酰亚胺化塑料)、聚苯并咪唑(PBI，酰亚胺化塑料)；无定形高性能热塑性塑料，其包括聚砜(PSU)、聚醚酰亚胺(PEI)、聚醚砜(PES)、聚芳基砜(PAS)；半晶态高性能热塑性塑料，其包括聚苯硫醚(PPS)、聚醚醚酮(PEEK)；以及半晶态高性能热塑性塑料、氟聚合物，其包括氟化乙烯丙烯(FEP)、乙烯-三氟氯乙烯共聚物(ECTFE)、乙烯、乙烯-四氟乙烯共聚物(ETFE)、聚三氟氯乙烯(PCTFE)、聚四氟乙烯(PTFE)，聚偏氟乙稀(PVDF)、全氟烷氧基树脂(PFA)。其它通常已知的医用材料包括弹性体有机硅聚合物、聚醚嵌段酰胺或热塑性共聚醚酯(PEBAX)以及诸如不锈钢和镍/钛合金的金属。
镶条1103内的远侧凹口1104和近侧凹口1106可用于促进第一直线致动器802定位于外壳槽812内。当密封装置在装载到输送系统上之前在第二管108上伸长时，分别为1104和1106的两个凹口之间的距离可以是密封装置100的长度。镶条1103的尺寸可设计成容纳多个装置长度并较佳地从约22.28厘米长起，其中远侧凹口1104的近侧端和近侧凹口1106的近侧端之间的距离约从6.25-13.32厘米起。凹口1104和1106可以呈任何形状，但较佳地为矩形。
然后，第一直线致动器802朝向外壳810的近侧端运动到槽812内的中点。这个动作致使第一管102朝近侧运动并使密封装置100的近侧端朝近侧运动，从而使密封装置100伸长。第一直线致动器802可以是任何形状(杆形、球形)，但较佳地成形为容纳临床医师的大拇指。第一直线致动器802可由具有合适的机械特性的任何材料，但较佳地由类似于镶条1103的材料构造成。第一直线致动器802的特征是形成于第一直线致动器802的顶部内、用于固定收回绳110的凹入齿。这个特征是较佳的，但也是可选的。这些齿可制成任何曲折路径或具有在密封装置100的装载、部署或收回过程中对收回绳110产生阻力所期望的任何形状。对应的突出齿(未示出)可形成于收回绳锁定件803的底面上。这些齿可装配到一起并牢固地保持收回绳。也可使用本领域中通常已知的用于固定小直径绳的其它方法并将在后面部分中详细讨论这些方法。
然后，第一直线致动器802向更近侧运动直至装置装载到第三管104内。在该动作过程中，弹簧1100将第一直线致动器802和主轴控制杆1000推到槽812的左侧并进入镶条1103内的近侧凹口1106。第二管108与密封装置100和第一管102一起朝近侧自由运动。当第一直线致动器802向近侧运动时，第二管108、密封装置100和第一管102滑动或平移到第三管104内。在第一直线致动器802位于其最近侧的位置时，系统又能以上述方式用盐水来冲洗。
在图12A-D中示出第一直线致动器802的替代实施例。图12A示出处于锁定的收回绳位置的替代直线致动器1108的立体图。直线致动器1108类似于直线致动器802的构造但具有收回绳锁定环1110和收回绳凹槽1112。图12B示出替代实施例1114，该实施例构造有延伸超出直线致动器的侧面以便于操作的拇指轮1116。拇指轮1116被拧到收回绳卷绕于其上的螺纹柱1118上。实施例1114还包含收回绳凹槽1120，收回绳在围绕螺纹柱1118固定之前被引导穿过该收回绳凹槽。图12C示出又一实施例1122，其利用了侧向装配的螺纹拇指轮1124，收回绳围绕该拇指轮卷绕，并通过将螺纹柱1124插入致动器1122侧面的螺纹孔(未示出)的操作来固定到致动器1122。在收回绳绕在螺纹柱1124之前，收回绳插入穿过收回绳凹槽1126。在图12D中示出另一实施例1128。实施例1128示出具有模制的拇指轮1130的直线致动器。拇指轮1130略微延伸超出直线致动器的边缘，从而便于直线致动器的操作。收回绳插入穿过绳凹槽1132并围绕螺纹柱(未示出)卷绕。然后，模制的拇指轮1130固定到固定收回绳的螺纹柱上。
在图9B中描述将密封装置100部署到缺损内。第一直线致动器802朝远侧运动直至到达止挡件。这种运动致使第一管102和第二管108在第三管104内朝向远侧运动。然后，直线致动器802必须运动到槽812内的右侧，抵抗弹簧1100。当直线致动器802运动到右侧时，主轴控制杆1000在滑动杆1102上转动。这种动作致使直线致动器802不在镶条1103内的近侧凹口1106处。在此动作之后，直线致动器802朝远侧进一步平移。这致使第一管102和密封装置的近侧孔眼202向运侧运动。也受到这个动作影响的是被阻止运动的密封装置100的远端。第一管102将该装置引出第三管104以使装置部署在缺损内。直线致动器802朝远侧运动到槽812的端部导致整个密封装置被部署。本领域的技术人员将认识到上述步骤可在某些点中止和反向以允许密封装置100的最佳定位。
在图9C中示出的流程图中示出锁定装置。收回绳锁定件803将从第一直线致动器802松开。临床医师通过抓持附连的锁定释放致动器808来抓持第二直线致动器806并将其向外壳810中间按压。第二直线致动器806可以是任何尺寸和形状，但尺寸较佳地设计成沿外壳810的纵向表面装配到槽1002内。直线致动器806借助于卡配件而装配有锁定释放致动器808。任何附连手段足以将锁定释放致动器808固定到直线致动器806，诸如胶水或如模制零件的构造。适于第二直线致动器806和锁定释放致动器808的材料可以是具有合适机械特性的任何材料，但较佳地类似于前述的手柄部件的材料。锁定释放致动器808设计成能使使用者牢固地抓持装置。可通过锁定释放致动器808的侧面上的凸起部来辅助抓持。这些凸起部可由类似于锁定释放致动器808的材料来制成或者可由具有高摩擦系数或比锁定释放致动器808顺应性更高的材料制成。这些凸起部还可通过磨碎、粗加工、表面内的凸起设计或纹状体与上面所列的材料结合来制成以进一步有助于装置的抓持。锁定释放致动器808的表面上的这些特征还可用于促进抓持，而无须使用抓持凸起部，并可直接施加到第二直线致动器806的侧向表面。槽1002可构造成具有止挡件以将第二直线致动器806保持在最远位置直至锁定释放密封装置。在图10和11中示出呈波纹区域形式的较佳的止挡件，但也可呈机械止挡件的任何方式。槽1002可具有任何长度，但较佳地具有足以朝近侧平移运动约第二直线致动器806的宽度加上约3.18厘米的长度。槽1002可以是容纳第二直线致动器806的任何形状。
在图13A和13B中示出第二直线致动器806的替代实施例。抓持可转动的锁定释放致动器1300并转动以实现锁定释放，而不是抓持锁定释放致动器808并致动第二直线致动器806。可转动的锁定释放致动器1300可包括窗口1302，该窗口阻止第一直线致动器802的前进运动。当被转动时，锁定释放致动器1300允许与图10中所示的锁定释放致动器806相同的动作。
一旦抓持第二直线致动器808，临床医师就可使第二直线致动器806朝近侧运动。该运动致使第三管104、主轴控制杆1000、镶条1103和第二管108朝近侧的运动。第二管108从装置的孔眼之间朝近侧运动。实现这种动作的替代方法是向手柄的远端，而不是向第二直线致动器806提供一种扭转机构。该扭转机构设有允许第三管104、主轴控制杆1000、镶条1103和第二管108与第二直线致动器806相同地运动的槽。
一旦实现锁定释放，收回绳锁定件803就被扭转以使其从第一直线致动器802移除并被拉动直至收回绳110不在输送系统内。收回绳110在一端部处附连于收回绳锁定件803。收回绳110可由诸如凯夫拉尔(纤维)挠性金属线、聚合物等的具有合适的机械特性的任何材料构造成。用于收回绳110的较佳材料是ePTFE纤维。收回绳锁定件803可以各种形状和尺寸来构造。可能的收回绳锁定件可设计成在直线致动器802内设有收回绳穿过的槽。在一种构造中，收回绳通过使线穿过在设置于直线致动器802内的拇指轮的轴线上的槽或孔来固定并通过扭转拇指轮来拉紧。替代的构造提供滑动锁，该锁使用摩擦来将锁与直线致动器802之间的收回绳结合起来。较佳的设计是如图11中所示将收回绳固定在形成于收回绳锁定件内的齿之间。
适合于构造收回绳锁定件803的材料类似于用于构造外壳810和其它手柄部件的材料。如前所述，为了抓持收回绳110，收回绳锁定件803较佳地具有对应于直线致动器802内的凹陷部的齿或凸起部。收回绳锁定件803可以各种形状和尺寸来构造以使收回绳110能被紧固。较佳的构造包括穿过收回绳锁定件803的孔，以使收回绳110穿过收回绳锁定件并打结。在扭转收回绳锁定件803之后，它被推动直至收回绳110从输送系统移除。
在图9C中所述的步骤四之前，密封装置100可如图9D中所示流程图中所述那样被取回。收回绳锁定件803可卡配到第一直线致动器802中。这用于将收回绳110锁定在位。然后，临床医师使第一直线致动器802运动到槽812的右边缘。第一直线致动器802在槽812内向右运动、按压到弹簧1100上，而主轴控制杆1000在滑动杆1102上转动到手柄的右侧。滑动杆1102较佳地呈圆形横截面，但本领域的技术人员将认识到各种横截面形状(例如，正方形或三角形)是可接受的。滑动杆1102还可以如图14A和B中所示的柄头簧(crownspring)1400的形状来构造。弹簧可插入穿过直线致动器的槽1402以允许直线致动器的前后平移。弹簧1100的替代实施例可以是弹簧，即模制成如由图15所示的第一直线致动器802的一体零件1500。在图16中示出弹簧1100的另一实施例。在此构造中，弹簧1600附连于外壳810并在第一直线致动器802上推动到键入位置。如上所述，本领域技术人员将认识到用作弹簧或模制零件的合适材料。第一直线致动器802不在远侧凹口1104内，且第二管108被阻止运动。第一直线致动器由临床医师朝近侧移动，从而使第一管102朝近侧运动。这种运动使密封装置100的近端朝近侧平移，从而使装置100伸长并允许其被拉到第三管104内。
示例：
下述示例示出可如何制成和/或使用本发明的各种实施例，而对本发明的范围没有限制。
示例1：
使用下述部件和组装过程来制造类似于图1的密封装置。
获得具有如下特性的膨胀型聚四氟乙烯材料：
甲醇泡点为1psi(磅/平方英寸)
质量/面积为2.2克/平方米
纵向最大负荷为1.6千克/英寸
厚度为0.0003英寸
纵向基质抗拉强度为92000psi(磅/平方英寸)
下面的试验方法和装备用于确定上述特性：使用具有1英寸直径底脚、0.2psi/秒的斜坡速率和甲醇的液态介质直径的用户定制机器来测量甲醇泡点。使用金属尺来测量材料的长度和宽度。使用平衡装置(加利福尼亚州圣何塞的ANG的型号GF-400的顶部加载平衡装置)对36x5英寸试样测量质量/面积。使用装备有10公斤测力计的材料试验机(宾夕法尼州亚格罗夫城的Instron(因斯创)型号5564)来测量纵向最大负荷。测量仪长度是1英寸，而横梁(位移)速度是25毫米/分钟。试样宽度是1英寸。沿材料的长度方向进行纵向拉伸试验测量。使用具有1/4英寸的底脚直径的厚度计(三丰的数字显示仪547-400)来测量厚度。使用下述方程来计算纵向基质抗拉强度(MTS)：使用公式：密度＝质量/体积来计算密度。
获得具有下述特性的具有FEP(氟化的乙烯丙烯共聚物)薄层的膨胀型聚四氟乙烯：
质量/面积为36.1克/平方米
纵向最大负荷为12.6千克/英寸
横向最大负荷为0.3千克/英寸
厚度为0.0012英寸
下述试验方法和装备用于确定上述特性：使用精密分析平衡装置(加利福尼亚州圣何塞的ANG的型号GF-400的顶部加载平衡装置)对试样面积为36x1英寸的试样来称重材料。使用金属尺来测量材料的长度和宽度。使用具有1/4英寸的底脚直径的数字厚度计(三丰的数字显示仪547-400)来测量材料厚度。使用装备有10公斤测力仪的材料试验机(宾夕法尼州亚格罗夫城的Instron(因斯创)型号5564)来测量最大横向负荷。试样宽度长度是1英寸，厚度计长度是1英寸，而横梁(位移)速度是25毫米/分钟。使用装备有200公斤测力仪的材料试验机(宾夕法尼州亚格罗夫城的Instron(因斯创)型号5564)来测量最大横向负荷。试样宽度长度是1英寸，厚度计长度是1英寸，而横梁(位移)速度是25毫米/分钟。沿材料的长度方向进行纵向拉伸试验测量，并沿垂直于长度方向的方向进行横向拉伸试验测量。
远侧孔眼通过首先获得直径为约0.23毫米的10％铂拉填型镍钛诺线(印第安纳州韦恩堡的韦恩堡金属公司(FortWayneMetals))的长度来构成。该线标记为“第一线”。第一线的自由端在其自身上加倍以形成开端环，且该开端环插入按钮。然后，按钮插到键入的中心销上。按钮成形为具有穿过中心以容纳键入的中心销的开口并具有允许其牢固地搁置在卷绕夹具内的特征。然后，键入的中心销(约0.51毫米的主轴线和约0.25毫米的副轴线以及约10.16毫米的长度)插入卷绕夹具的中心。键入的中心销由高强度钢(山高法格斯(SecoFagersta)的超级含钴高速钢刀头，MSC#56424278)制成。根据制造规程，钢在1475℉下回火一个小时。卷绕夹具和按钮在在本厂内由耐腐蚀工具钢制成。
获得相同类型的拉填型镍钛诺线的第二长度并标记为“第五线”。通过将配重附连于线的端部而拉紧第一、第五和附加的三条线。然后，第一线和第五线围绕第一线的自由端卷绕一整圈。三条附加的线被引入卷绕夹具，并且所有五条线都围绕第一线的自由端卷绕成约1.98毫米的高度。
然后，通过分离五条线并将它们固定到围绕卷绕夹具的周向边缘的径向凹槽内来形成远侧盘状物。半径形成有15毫米的直径。每条线形成远侧盘状物的一个瓣(状物)。使瓣状部的曲率半径最大化，以将线内的尖锐弯角减到最少。
中心孔眼通过将线集合起来并将它们围绕第一线的自由端和键入的中心销卷绕成约1.98毫米的高度来形成。然后，线被分离并固定到沿卷绕夹具的周向边缘的径向凹槽内，从而形成具有15毫米半径的近侧盘状物。
通过再次将五条线集合起来并将它们围绕第一线的自由端和键入的中心销卷绕成约1.98毫米的高度来形成近侧孔眼。然后，五条线被分离并通过将不锈钢板置于线顶部上并用螺钉向下锁定该板来固定。然后，第一线的自由端围绕具有约3.18毫米直径的不锈钢销卷绕一圈并类似地固定到其它五条线。
然后，夹具与密封装置一起从稳定固定件中移除并放置到炉(BlueMSPX电强制空气对流炉)中，使线如现有技术中通常已知那样热定形。然后，装置和夹具被水淬。固定的线从固定板中释放，且装置被冷却并从夹具和键入的中心销移除。然后，装置被置于变平的PEEK(聚醚醚酮)片上并用手修剪成远侧孔眼的外径。锁定环用手修剪到刚超过整一圈的位置并被拉过近侧孔眼和中心孔眼。
装置从PEEK主轴被推到具有椭圆形横截面的键入的不锈钢加工主轴上。主轴由具有椭圆形横截面的整平的不锈钢线(印第安纳州韦恩堡的韦恩堡金属公司)生产以具有在近侧孔眼和中心孔眼之间的45°顺时针扭转以及在中心孔眼和远侧孔眼之间第二45°顺时针扭转。
然后，加工主轴和装置被置于稳定固定件内，该固定件被置于FEP粉末涂覆机(C-30，静电技术公司(ElectrostaticTechnology，Inc.)布拉德福，CN)中并被处理直至完全涂覆好。过多的FEP粉末从该装置中去除。利用抽真空方式将FEP从锁定环、加工主轴和突起中去除。加工主轴和装置从稳定固定件中移除，置于炉中并被烘烤以如现有技术中通常已知那样使FEP涂层定形。
获得空心薄膜主轴(35.99毫米外径，76.2厘米长，不锈钢材质)。获得具有22.22毫米槽宽的膨胀型聚四氟乙烯材料并将其装载到螺旋缠绕机上。机器在本厂内制造以任何期望的角度、张力和速率缠绕PTFE(聚四氟乙烯)材料。主轴装载到缠绕机上，且材料围绕空心主轴的周缘缠绕三遍。然后，材料以约8°的角度围绕到主轴缠绕主轴的长度上。缠绕的方向反向，且材料以相同角度缠绕于其上。第三和第四层以相同方式以缝线偏移来缠绕。主轴从缠绕机中移除，插入炉中并以370℃烘烤45分钟。缠绕好的主轴从炉中移出并被允许冷却到室温。所得的PTFE管从主轴拆下。
然后，PTFE管被切成140毫米并用手拉伸到期望长度155毫米。然后，PTFE管被拉到框上。然后，PTFE管被压接到中心孔眼上并被压接到远侧和近侧孔眼上。
然后，具有FEP(氟化乙丙烯)材料薄层的膨胀型聚四氟乙烯围绕从中心孔眼开始的孔眼缠绕四遍。缠绕的孔眼使用焊烙铁定位搭焊到位。然后，PTFE管在320℃下热定形三分钟并修剪到近侧孔眼和远侧孔眼的最外位置。装置从主轴拆除。
示例2：
使用下述部件和组装过程来制造类似于图6的密封装置。
获得膨胀型聚四氟乙烯和具有类似于示例1中所述的FEP(氟化的乙烯丙烯共聚物)材料薄层的膨胀型聚四氟乙烯。
远侧孔眼通过首先获得具有约0.23毫米直径的10％铂拉填镍钛诺线(印第安纳州韦恩堡的韦恩堡金属公司(FortWayneMetals))的长度来构成。该线标记为“第一线”。第一线的自由端在其自身上加倍以形成开端环，且该开端环插入按钮。然后，按钮被插到键入的中心销上。按钮成形成具有穿过中心以容纳键入的中心销的开口并具有允许其牢固地停留在卷绕夹具内的特征。键入的中心销(主轴线为约5.79毫米，副轴线为约0.25毫米以及长度为约10.16毫米)被插入卷绕夹具的中心内。键入的中心销由高强度钢(山高法格斯(SecoFagersta)的超级含钴高速钢刀头，MSC#56424278)制成。卷绕夹具和按钮在本厂内由耐腐蚀工具钢制成。
获得相同类型的拉填型镍钛诺线的第二长度并标记为“第五线”。通过将配重附连于线的端部而拉紧第一、第五和附加的三条线。然后，第一线和第五线围绕第一线的自由端卷绕一整圈。三条附加的线引入卷绕夹具并且所有五条线都围绕第一线的自由端卷绕成约1.98毫米的高度。
然后，通过分离五条线并将它们固定到围绕卷绕夹具的周向边缘的径向凹槽内来形成装置。半径形成有15毫米的直径。每条线围绕卷绕夹具绕一整圈。
通过将五条线集合起来并将它们围绕第一线的自由端和键入的中心销卷绕成约1.98毫米的高度来形成近侧孔眼。然后，五条线被分离并通过将不锈钢板置于线顶部上并用螺钉向下锁定该板来固定。然后，第一线的自由端围绕具有约3.18毫米直径的不锈钢销卷绕一圈并类似地固定到其它五条线。
夹具与密封装置一起从稳定固定件中移除并放置到炉(BlueMSPX电强制空气对流炉)中，线在炉中如现有技术中通常已知那样被部分热定形。然后，装置和夹具被水淬。固定的线从固定板中释放，然后装置被冷却并从夹具和键入的中心销移除。锁定环用手修剪到刚超过整一圈的位置并被拉过近侧孔眼和中心孔眼。
装置从PEEK主轴被推到具有椭圆形横截面的键入的不锈钢加工主轴上。
主轴由具有椭圆形横截面的整平的不锈钢线(印第安纳州韦恩堡的韦恩堡金属公司)生产。
然后，装置部分地从转移主轴的一端部移除。移除的装置端部顺时针扭转约180°并重新定位到转移主轴上。装置和转移主轴被置于炉(BlueMSPX电强制空气对流炉)中，线在炉中如现有技术中通常已知那样被热定形。
然后，转移主轴和装置被置于稳定固定件内，该固定件被置于FEP粉末涂覆机(C-30，静电技术公司(ElectrostaticTechnology，Inc.)布拉德福，CN)中并被处理直至完全涂覆好。过多的FEP粉末从该装置中去除。利用抽真空方式将FEP粉末从锁定环、加工主轴和突起中去除。然后，转移主轴和装置从稳定固定件中移除、置于炉中并被烘烤以如现有技术中通常已知那样使FEP涂层定形。
获得空心薄膜主轴(外径为35.99毫米，长度为76.2厘米，不锈钢材质)。获得具有22.24毫米槽宽的ePTFE材料并将其装载到螺旋缠绕机上。该机器在本厂内制造而以期望的角度、张力和速率来缠绕ptfe薄膜。主轴装载到缠绕机上，且薄膜围绕空心主轴的周缘绕三圈。然后，ePTFE材料以约8°的角度围绕主轴缠绕主轴的长度上。缠绕方向反向，且材料以相同角度缠绕于其上。第三层和第四层以同样方式以缝线偏移来缠绕。主轴从缠绕机中移出，插入炉中并以370℃烘烤45分钟。缠绕好的主轴从炉中移出并被允许冷却到室温。所得的PTFE管从主轴拆下。
然后，ePTFE管被切成约140毫米并用手拉伸到期望的155毫米的长度。然后，ePTFE管被拉到框上。然后，ePTFE管被压接到远侧孔眼和近侧孔眼上。然后，具有FEP(氟化的乙烯丙烯共聚物)薄层的ePTFE管围绕孔眼缠绕四遍。包裹好的孔眼用焊烙铁定位搭焊到位。然后，ePTFE管在320℃下被热固三分钟并修剪到近侧孔眼和远侧孔眼的最外位置。然后，该装置从主轴移除。
示例3：
使用下述部件和组装过程来制造类似于图8的手柄组件。
使用注模工艺来制成手柄组件的部件。零件由轮廓塑料公司(ContourPlastic)(威斯康星州的鲍德温)使用Lustran348来制成。这种材料适合用于医疗装置并具有引人注目的48.2Mpa的抗拉强度和2.62GPa的拉伸模量。使用注模工艺和Lustran348来制成九个零件。这些零件包括第二直线致动器、冲洗衬垫保持件、第一直线致动器、收回绳锁定件、主轴控制杆、左侧主体外壳、镶条、右侧主体外壳和锁定释放致动器。
用于组装手柄所需的其它材料是可购得的物件。用现有技术中通常已知的手糊工艺形成的导管的量级(新罕布什尔的泰利富医疗，Jaffrey)为外径0.33毫米和内径0.048毫米，且铂铱标记带置于远侧梢端的端部附近。导管的主体是具有PTFE内衬和不锈钢编织物(braid)(65PPI)的Pebax7233管，且导管的最远侧20.32毫米由6333Pebax(0.027毫米内径和0.033毫米外径)和远端内的曲线(39.98毫米半径)构成。由激光器形成的引导线端口被置于导管内标记带的近侧。由硅树脂制成的冲洗衬垫或U杯形衬垫(22.99毫米深度，内径从2.89毫米渐缩到1.85毫米，内径从6.71毫米渐缩到7.75毫米)由纽约州兰开斯特的AppleRubber生产。获得具有约6英寸的挠性pvc(聚氯乙烯)管的冲洗端口(犹他州的南乔丹的MeritMedical)，该管带有3.18毫米外径的阴鲁尔连接器。快速定形的腈基丙烯酸酯粘合剂由内部库存供给。不锈钢海波管从小零件公司(SmallParts，Inc.)(1.45毫米外径，1.30毫米内径，30.48毫米长度)定购。滑动杆(PTFE涂覆的不锈钢海波管，3.18毫米外径，1.65毫米内径，33.02毫米长度)从应用塑料公司(AppliedPlastics)获得。控制弹簧(PTFE涂覆的不锈钢板簧，0.10毫米厚度，副凸缘长度3毫米，主凸缘长度10.11毫米，总长度15.88毫米)从纽约州伊萨卡的因柯德马(Incodema)定购。
部件的剩余部分由内部库存供给或在本厂制造。所有三腔管都由具有20％硫酸钡的Pebax7233来制造。两个三腔管具有0.25毫米的外径(O.D.)。一个三腔管具有两个内径(I.D.)为0.035毫米、一个内腔内径为0.15毫米的圆形内腔。一个三腔管具有椭圆形横截面的一个内腔，其中两个内径为0.036毫米，而一个内径为0.127x0.07毫米。一个加工主轴具有从圆形(外径为0.16毫米)过渡到椭圆形(外径为0.14x0.07毫米)的横截面形状。PTFE涂覆的不锈钢线由内部库存(外径0.03毫米)获得。标准鲁尔接头由内部库存获得。由内部库存获得具有1.27x0.69毫米外径的椭圆形横截面的PEEK(聚醚醚酮)第二管挤压件。
以下述方式制成第一管。获得具有圆形内腔的一个三腔挤压管。获得具有椭圆形横截面的一个内腔的另一三腔挤压管。还获得具有从圆形(1.52毫米外径)过渡到椭圆形(1.39x0.81毫米外径)的不锈钢加工主轴。两个挤压管都装载到主轴上，而主轴被插穿过两个管上的较大内腔。两根较小的PTFE涂覆的不锈钢线被插入穿过两个挤压管的较小内腔。主轴和管被插入RF(射频)模具(2.51毫米内径，4,45毫米长度，由D2工具钢制成)。两个导管的接合点定位在RF模具的中心。RF模具和主轴被置于RF焊接机上的RF线圈中部内(纽约州斯克茨维尔的HotShotI)并如现有技术中通常已知那样被焊接。当部件回流时，压力施加到挤压管的每个端部以融合各管的接合点。然后，用压缩空气喷射模具以冷却模具并使Pebax定形。挤压管和模具从RF机器中移除并且挤压管从模具中移除。加工主轴和线从挤压管的内腔中移除。
润滑涂层可施加至第二管。硅树脂模具释放喷雾(新泽西州林德赫斯特的杜威产品公司(DwightProducts，Inc.)的NixStixX-9032A)可喷到第二管的约远侧(从远端起)30厘米上并允许借助于通风罩在环境温度下进行干燥。
以如下方式制成第三管子组件。用直剃刀在离导管的近端约6.35厘米处将导管平分。获得同轴的阴和阳鲁尔连接器(纽约州埃奇伍德的科斯纳(Qosina))并钻成3.45毫米的内径。U.V.(紫外线)固化的粘合剂(Loctite3041)施加到导管的被平分的端部并且钻出的鲁尔接头被附连。粘合剂按照制造规程固化，且鲁尔接头被拧到一起。
以如下方式制成第二直线致动器子组件。获得第二直线致动器、冲洗端口、冲洗衬垫保持件和硅树脂冲洗衬垫。冲洗衬垫被插入第二直线致动器的背面，其中冲洗衬垫的U形部分朝向远侧。冲洗衬垫保持件装配到第二直线致动器内部的顶部上。氰基丙烯酸酯胶水涂覆到衬垫保持件周围以将衬垫保持件保持在位。冲洗端口被置于第二直线致动器内的孔中，且紫外线固化粘合剂根据制造规程来涂覆和固化。
获得第一管，且氰基丙烯酸酯被涂覆到导管的离端部2.54厘米带内的圆形内径部分的外表面。然后，导管被插入控制往复件(shuttle)的远端内，直至导管与控制往复件的背面齐平。导管定向成两个较小的内腔是水平的并在圆形内腔的顶部上。收回绳锁定件被卡配到控制往复件上。
以下述方式制造第二管子组件。四英寸的直径0.033毫米的镍钛诺线被插入第二管挤压件。具有线插入件的第二管挤压件被插入海波管。用手将海波管的远端压接三遍。
第一管的远端穿过主轴控制杆的顶部并穿过主轴控制杆的远端上的顶部孔。第二管的远端被拧到控制导管的近端中。第二管被推入第一管，直至海波管的约4英寸从控制导管的端部突出。氰基丙烯酸酯粘合剂被涂覆到海波管的近端超过约12.7毫米的部分。该部分被插入主轴控制杆的近端内的顶部孔中直至与主轴控制杆的背面齐平。然后，第一管的远端被拧入第二直线致动器的远端。第二直线致动器运动到控制导管上的最后面的位置。
然后，镶条被装配到左侧主体外壳内。镶条定向成镶条内的凹槽装配到左侧外壳内的脊上。导管子组件被置于左侧主体外壳中，因而，主轴控制杆装配到镶条中，而第二直线致动器装配到左侧主体外壳的远端内的槽中。滑动杆被插入穿过镶条、主轴控制杆、控制往复件和第二直线致动器内的各开口。滑动杆搁置在左侧主体外壳内的两个支承体上。控制弹簧被插入右侧主体外壳内，因而它装配到相对的齿中。然后，右侧主体外壳被置于左侧主体外壳上并且两者被卡配到一起。两个螺钉(#4-24x1/2英寸螺纹成形盘状物头)被插入左侧主体外壳上的可用孔内并拧紧。使锁定释放致动器在第二直线致动器的右凸耳上卡配到位，并用一滴氰基丙烯酸酯粘合剂以确保它保持粘附。
第二直线致动器、控制往复件和主轴控制杆运动到它们最前面的位置。第二直线致动器被向后拉回，然后返回至其前进位置。第一管的远端借助于刀片用手修剪到从第三管的梢端起测量为1.27毫米。镶条被向前推动。第二管用手使用刀片修剪成从控制导管的最远端测量为约0.76毫米长度。获得约4英寸长的镍钛诺线(0.30毫米直径)。用伸长的涂覆器梢端将氰基丙烯酸酯粘合剂涂覆到第二管的梢端。镍钛诺线被插入锁定件的梢端内，而另一条线用于将镍钛诺线插入第二管内约2毫米。
第二直线致动器被向后拉回，并且从控制导管冲压出槽。槽具有约与导管的椭圆形内腔的较小轴线相同的宽度。剃刀用于将槽削成约19.05毫米的最终长度。然后，第二直线致动器和镶条运动到前进位置。
获得3.05米长的收回绳(具有0.25毫米外径的PTFE纤维)和1.52米(0.15毫米外径)的镍钛诺线。镍钛诺线被插入第一管内的0.04毫米内腔中的一个并被推动穿过该内腔直至线从内腔出来进入手柄。镊子用于抓住线并将其拉出手柄的槽。使约76.2毫米的线从控制导管的远端突出。环通过将松的端部在控制导管的远端处插入相同内腔中而形成于线内。然后，约76.2毫米的收回绳穿过所形成的环。镍钛诺线被拉过导管直至收回绳突出到手柄内。
获得密封装置。用收回绳将常用于缝合的类型的针穿起来，且针穿过与锁定环相对的PTFE袋并穿过密封装置的近侧孔眼的内腔。然后，镍钛诺线穿过第一管内剩余的未被占据的0.04毫米内腔，而线的环端部指向远侧。针从收回绳拆下，且线穿过镍钛诺线上的环。然后，收回绳以前述方法被拉过导管。
控制往复件缩回约12.7毫米。然后，第二管穿过装置的孔眼。镊子用于抓住收回绳并将其拉过手柄并拉到手柄的外侧。环形成于小直径镍钛诺线的一部分内。环被插穿过控制往复件顶部的远侧部分内的孔。收回绳穿过这个环并被拉过控制往复件的远侧部分内的孔。收回绳从控制往复件中移除，且收回绳的一个自由端部从底部插过收回绳锁定件内的孔。四个单结系在线内。过多的线用手修剪掉并且收回绳锁定件返回到控制往复件。
剩余的自由收回绳被拉动直至完全没有松弛部分。收回绳的剩余的自由端被插入控制往复件顶部的前部内的孔中。收回绳被拉动直至被拉紧并且收回绳锁定件被卡接闭合。用手将收回绳修剪为约20.32厘米。
通过获得具有尖锐梢端的焊烙铁并将其加热到约500℉来张开第二管。烙铁的梢端被插入第二管直至产生直径近1.39毫米的张口。装置上的锁定环被冷却。

Claims (17)

1.一种密封装置，包括：
可膨胀框，所述可膨胀框由多根线构成，所述多根线的每一根从其近端螺旋且连续地延伸到远端且经过所述近端和所述远端之间的对中区域；
所述多根线各自的第一和第二部分分别形成卷绕的近侧孔眼和卷绕的远侧孔眼，并且当所述密封装置处于膨胀构造时所述可膨胀框形成近侧盘状物和远侧盘状物；
其中，所述近侧盘状物和所述远侧盘状物各自位于所述近侧孔眼和所述远侧孔眼之间，所述近侧盘状物和所述远侧盘状物各自包括由所述多根线形成的相应瓣状部，所述相应瓣状部由所述多根线形成，相邻的所述瓣状部具有重叠区和未支承部分，各所述瓣状部构造成与生物组织相符；以及
密封构件，所述密封构件至少部分地覆盖所述相应瓣状部。
2.如权利要求1所述的密封装置，其特征在于，所述可膨胀框还包括卷绕的中间孔眼，所述中间孔眼由所述多根线构成且位于所述近侧盘状物和所述远侧盘状物之间。
3.如权利要求1所述的密封装置，其特征在于，所述可膨胀框还包括由多根线构成的中间孔眼。
4.如权利要求3所述的密封装置，其特征在于，所述密封构件基本上完全包封所述可膨胀框。
5.如权利要求1所述的密封装置，其特征在于，所述可膨胀线框由五根线构成。
6.如权利要求1所述的密封装置，其特征在于，所述密封构件包括从由聚酯、聚乙烯、聚丙烯、含氟聚合物、聚氨酯、硅树脂、尼龙和丝绸材料组中选择的材料。
7.如权利要求6所述的密封装置，其特征在于，所述含氟聚合物包括聚四氟乙烯。
8.如权利要求7所述的密封装置，其特征在于，所述含氟聚合物包括膨胀型聚四氟乙烯。
9.如权利要求1所述的密封装置，其特征在于，所述多根线包括镍钛诺。
10.如权利要求1所述的密封装置，其特征在于，所述密封构件包括内表面，所述内表面的至少一部分附连于所述多根线。
11.如权利要求1所述的密封装置，其特征在于，还包括位于所述远侧孔眼远侧的远侧突起。
12.如权利要求11所述的密封装置，其特征在于，还包括装置锁定环。
13.如权利要求1所述的密封装置，其特征在于，所述孔眼中的至少一个形成为非圆形。
14.如权利要求10所述的密封装置，其特征在于，所述密封构件的所述内表面藉由粘合剂附连于所述多根线。
15.如权利要求14所述的密封装置，其特征在于，所述粘合剂包括FEP。
16.如权利要求9所述的密封装置，其特征在于，所述镍钛诺包括重量百分比为10％的铂。
17.如权利要求16所述的密封装置，其特征在于，所述镍钛诺是拉填型的镍钛诺。
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