CN113491545A - 用于手术进入组件的密封组件和其制造方法 - Google Patents

用于手术进入组件的密封组件和其制造方法 Download PDF

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CN113491545A
CN113491545A CN202110260539.0A CN202110260539A CN113491545A CN 113491545 A CN113491545 A CN 113491545A CN 202110260539 A CN202110260539 A CN 202110260539A CN 113491545 A CN113491545 A CN 113491545A
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罗伊·J·皮列特雷
尼科莱特·R·拉皮埃尔
詹森·米克思
埃里克·布朗
贾斯廷·托马斯
马修·A·迪尼诺
雅各布·C·巴里尔
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    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
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Abstract

本发明涉及用于手术进入组件的密封组件和其制造方法，并提供一种制造用于手术进入组件的密封组件的方法，其包括形成具有整体构造的密封组件。所述密封组件包括支撑构件、连接到所述支撑构件的密封区段、设置在相邻的密封区段之间并且使所述相邻的密封区段互连的桥，和从每个密封区段延伸的多个支座。所述方法还包括将所述密封组件放置到处理浴中、切割所述桥和折叠所述密封组件。

Description

用于手术进入组件的密封组件和其制造方法
技术领域
公开大体上涉及用于微创手术的手术进入组件。特别地，本公开涉及用于手术进入组件的密封组件和其制造。
背景技术
包括内窥镜和腹腔镜程序的微创手术程序准许在远离组织内的开口处对器官、组织和血管执行手术。在腹腔镜程序中，必须在期望的手术部位上产生工作空间。将典型地为CO2的吹入流体引入到患者的腹部中，以产生被称为气腹的充气状态。手术进入组件用于允许将手术仪器和内窥镜(或其它可视化工具)引入腹腔以执行一个或多个手术任务。这些手术进入组件维持气腹压力，因为它们具有一个或多个适于手术仪器的密封件。典型地，在手术进入组件中不存在手术器械的情况下，手术进入组件中的“零密封”将手术进入组件密封，并且器械密封件围绕已经穿过手术进入组件插入的手术器械进行密封。
当今市场上手术仪器广泛需要能够适应和调节多种大小的手术仪器并且承受手术仪器的多次插入的坚固密封件。一些手术仪器可包括可撕裂或以其他方式损坏密封件的尖锐边缘和/或一些密封件(例如，具有实心内径的密封件)承受较高的插入力，并且对某些手术仪器的耐用性较差(例如，密封件可在插入期间裂开，导致密封件泄漏或脱离进入患者的腹腔中)。因此，具有改进的密封耐久性的手术进入组件以及其容易和一致地的制造方法将为有益的。
发明内容
在一个方面，本公开提供一种制造用于手术进入组件的密封组件的方法，其包括形成具有整体构造的密封组件。密封组件包括支撑构件、连接到支撑构件的密封区段、设置在相邻的密封区段之间并且使相邻的密封区段互连的桥；和从每个密封区段延伸的多个支座。方法还包括将密封组件放置到处理浴中、切割桥和折叠密封组件。
形成密封组件可包括由通用材料模制密封组件。
将密封组件放置到处理浴中可包括将密封组件放置到氯化浴中。
将密封组件放置到处理浴中可包括将多个密封组件放置到处理浴中。
方法可另外包括在切割桥之前，从处理浴中移除密封组件。
折叠密封组件可包括将密封区段定位在支撑构件附近。定位密封区段可包括使密封区段以顺序模式重叠。
在另一方面，本公开提供一种用于手术进入组件的密封组件，其包括支撑构件、连接到支撑构件的密封区段、设置在相邻的密封区段之间的桥，和从密封区段中的每一个延伸的多个支座。密封组件具有其中密封区段从支撑构件径向向外延伸的基本上平面的展开状态和其中密封区段定位在支撑构件附近的折叠状态。
密封区段可包括第一、第二、第三、第四、第五和第六密封区段。支撑构件可为六边形的。
当密封组件处于折叠状态时，每个密封区段可在顺时针方向和逆时针方向中的每一个上与两个相邻的密封区段重叠。
支撑构件可限定穿过其中的中心开口，并且在折叠状态下，密封区段的内边缘可限定具有不连续的密封圆周的开口。密封区段的开口可与支撑构件的中心开口同心。每个密封区段的内边缘可为基本上V形的。
每个密封区段可通过连接器部分连接到支撑构件。每个连接器部分可包括活动铰链以准许相对于支撑构件折叠相应的密封区段。
当密封组件处于展开状态时，桥可在相邻的密封区段之间连续地延伸，使得密封区段互连，并且当密封组件处于折叠状态时，桥可在相邻的密封区段之间中断，使得密封区段彼此独立。
多个支座可为材料的局部区域，其厚度大于支撑构件、密封区段和桥的厚度。多个支座可从每个密封区段的侧边缘延伸，并且当密封组件处于折叠状态时，多个支座可设置在密封组件的外部端子边缘处。多个支座可设置在每个密封区段上的相同位置。
在附图和以下描述中阐述本公开的一个或多个方面的细节。本公开中描述的方面的其它特征、目的和优点将从描述和附图以及权利要求书中显而易见。
附图说明
图1为根据本公开的方面的手术进入组件的侧视透视图；
图2为沿截面线2-2截取的图1所示的手术进入组件的侧视横截面视图；
图3为零件分开的阀组件的分解透视图，包括定心机构、防护组件、密封组件和保持器组件；
图4为图3所示的密封组件在初始状态或预组装状态下的顶部平面图；
图5为图4所示的密封组件在完全折叠或组装状态下的顶部透视图；和
图6为图3所示的阀组件在组装时的底部透视图。
具体实施方式
在下文中参考附图描述本公开的各方面；然而，应理解，所公开的方面仅示范本公开，并且可以各种形式体现。未详细描述众所周知的功能或构造以避免在不必要的细节上混淆本公开。因此，本文中所公开的具体结构和功能细节不应解释为限制性的，而仅是作为权利要求书的基础，并且作为代表性的基础，用于教示本领域的技术人员在实际中，以任何适当的详细结构来不同地应用本公开。
相似的参考标号贯穿附图的描述指代类似或相同的元件。贯穿本说明书，术语“近侧”指代较靠近使用者的结构的部分或其部件，并且术语“远侧”指代距使用者较远的结构的部分或其部件。
具有闭塞器的手术进入组件(称为套管针组件)在微创手术(例如腹腔镜手术)期间采用，并且提供手术器械进入充气的体腔(如腹腔)的密封进入。本公开的手术进入组件包括安装在插管上的器械阀壳体。闭塞器(未示出)可穿过器械阀壳体和插管插入。闭塞器可具有钝的远端，或带刀片或无刀片的穿透远端，并且可用于切开和/或分离腹壁的组织，使得可将手术进入组件引入腹部。闭塞器的手柄可接合或选择性地锁定到手术进入组件的器械阀壳体中。
通过形成穿过解剖结构的新通道，或通过穿过解剖结构的现有开口，套管针组件用于隧穿解剖结构，例如腹壁。一旦具有闭塞器的手术进入组件已经隧穿解剖结构，就将闭塞器移除，从而将手术进入组件留在适当位置。手术进入组件的器械阀壳体包括阀，所述阀防止吹入流体从体腔逸出，同时还允许将手术器械插入体腔中。
在各种方面中，可提供无刀片的光学套管针闭塞器，其准许在手术程序中分离组织平面，并且在体组织纤维分离时使体组织纤维可视化，从而准许控制体组织纤维跨过体壁的穿行。在其它方面中，套管针闭塞器可为无刀片的，但不是光学的，例如，没有通过套管针闭塞器的远侧尖端提供其同时的可视化。可提供无刀片的套管针闭塞器，以在手术程序期间对腹膜进行钝性解剖。
适用于本公开的手术进入组件的各种套管针闭塞器为已知的，并且包括例如带刀片的、无刀片的、钝的、光学的和非光学的套管针闭塞器。对于包括示范性套管针闭塞器和示范性插管的示范性套管针组件的结构和功能的详细描述，请参看PCT公开第WO 2016/186905号(“'905公开”)，其内容在此以全文引用的方式并入本文中。
现在首先参考图1，根据本公开的方面的手术进入组件被整体上示出为手术进入组件100。手术进入组件100包括插管102和固定到插管102的器械阀壳体110。对于示范性手术进入组件的详细描述，请参看'905公开。
参考图2，手术进入组件100的器械阀壳体110包括上部壳体区段112、下部壳体区段114和内部壳体区段116。上部壳体区段112、下部壳体区段114和内部壳体区段116被配置成将阀组件120支撑在插管102的近端上。更具体地，内部壳体区段116被固定在上部壳体区段112和下部壳体区段114之间，并且阀组件120被接纳在内部壳体区段116和下部壳体区段114之间。器械阀壳体110的上部壳体区段112和下部壳体区段114可选择性地附接到内部壳体区段116以及从所述内部壳体区段116拆卸。下部壳体区段114可以可释放地或永久地附接到插管102的插管管体104(图1)。在各方面中，器械阀壳体110的上部壳体区段112和下部壳体区段114中的一个或两个可包括滚花、凹痕、突片，或以其他方式被配置成促进由临床医生进行接合。
手术进入组件100还可包括用于使手术进入组件100稳定的特征。举例来说，插管管体104的远端可携带从内侧接合腹部的球囊锚或另一种可膨胀构件。举例来说，参见美国专利第7,300,448号，其内容在此以全文引用的方式并入本文中。腹壁的相对侧上的特征可用于另外使手术进入组件100稳定，如粘合突片或可调节的泡沫套环。
器械阀壳体110的上部壳体区段112、下部壳体区段114和内部壳体区段116限定用于接纳手术器械(未示出)的纵向通道111。阀组件120被支撑在器械阀壳体110内以提供手术器械(未示出)穿过手术进入组件100的密封通道。
具体参考图2和3，支撑在器械阀壳体110中的阀组件120包括定心机构130、防护组件140、密封组件160和保持器组件180。当手术器械穿过阀组件120被接纳时，阀组件120的定心机构130准许阀组件120相对于器械阀壳体110径向地移动，并且一旦手术器械从器械阀壳体110内被抽出，所述定心机构就将阀组件120返回到大体上居中位置。防护组件140在手术器械穿过密封组件160的插入和抽出期间保护密封组件160。密封组件160提供手术器械穿过器械阀壳体110的密封通道。保持器组件180将定心机构130、防护组件140和密封组件160维持在彼此对齐的关系。
继续参考图2和3，如上所述，阀组件120的定心机构130被配置成在没有手术器械穿过阀组件120的情况下将阀组件120维持在器械阀壳体110的中心。在各方面中，并且如图所示，定心机构130包括外部环形垫圈132、内部环形垫圈134以及设置在外部环形垫圈132和内部环形垫圈134之间的波纹管136。外部环形垫圈132接纳在内部壳体区段116和下部壳体区段114之间，以将定心机构130保持在器械阀壳体110内。内部环形垫圈134支撑防护组件140。对于示范性定心机构的结构和功能的详细描述，请参看美国专利第6,702,787号，其内容在此以全文引用的方式并入本文中。
尽管定心机构130被示出为具有波纹管136，但是阀组件120可包括替代的定心机构。举例来说，定心机构可包括环形基座和从基座延伸的多个辐条，如美国专利申请公开第2015/0025477号(“'477公开”)中所描述，其内容在此以全文引用的方式并入本文中。可以设想的是，定心机构可包括多组辐条，如在'477公开中所公开的。
继续参考图2和3，当手术器械(未示出)穿过器械阀壳体110时，阀组件120的防护组件140被配置成保护密封组件160。防护组件140包括垫圈部分142和第一瓣144、第二瓣146、第三瓣148和第四瓣150。第一瓣144、第二瓣146、第三瓣148和第四瓣150在它们之间限定开口141，以有助于手术器械(未示出)穿过防护组件140的密封通道。尽管被示出为包括四(4)个瓣，但是可以设想的是，防护组件140可包括任何合适数量的瓣，并且瓣可包括任何大小或配置的襟翼部分。对于其它示范性防护组件的结构和功能的详细描述，请参看美国专利第5,895,377号和第6,569,120号和美国专利申请第16/394,043号和第16/238,823号，其每一者的内容在此以全文引用的方式并入本文中。
阀组件120的密封组件160被配置成围绕穿过器械阀壳体110(图1)的手术器械的外表面提供密封。在各方面中，并且如图所示，密封组件160形成平坦的密封主体；然而，可以设想的是，本公开的各方面可被修改以与圆锥形密封主体一起使用。
现在转到图4，密封组件160被示出为处于初始或预组装状态。密封组件160包括支撑构件162，以及通过相应的连接器部分164a、166a、168a、170a、172a、174a固定到支撑构件162的第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174。如图所示，连接器部分164a、166a、168a、170a、172a、174a可包括一个或多个活动铰链，或者以其他方式被配置成准许相对于支撑构件162折叠相应的第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174。
在各方面中，密封组件160的支撑构件162和第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174由相同的材料形成，包括例如，聚氨酯、聚异戊二烯或硅酮弹性体(例如液体硅酮橡胶)。可替代地，支撑构件162以及第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174可由不同的材料形成。在一些方面，支撑构件162和/或第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174可包括一个或多个织物层。
密封组件160的支撑构件162包括六边形主体或垫圈部分162a和支撑在垫圈部分162a内的密封部分162b。垫圈部分162a和密封部分162b可由相同或不同的材料形成。密封部分162b限定中心开口161。支撑构件162a限定与从保持器组件180的上部保持器构件182延伸的多个销186(图3)相对应的多个开口163。当密封组件160处于折叠配置时，密封部分162a为第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174提供额外的支撑。
在各方面中，并且如图所示，支撑构件162的垫圈部分162a以及密封部分162b与第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174具有一体的构造，即，整体的构造。通过将密封组件160的支撑构件162的垫圈部分162a与密封部分162b结合并且在支撑构件162的垫圈部分162a上形成第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174，而不是包括用于密封部分的垫圈部分和用于第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174的单独的垫圈部分，减少密封组件160中的部件的数量，并且最终减少阀组件120中的部件的数量。密封部分162b以及第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174与同一垫圈部分162的结合也减少组装时间并且降低材料成本。
当处于折叠或组装状态时(图5)，密封组件160的第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174限定开口161a，其被配置成接纳以密封方式插入穿过阀组件120(图3)的手术器械(未示出)。第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174形成非连续的或虚拟的密封圆周，以减少在穿过阀组件120插入、操控和/或撤回手术器械(未示出)期间的撕裂。
密封组件160的第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174中的每一个包括翼形主体。当密封组件160处于折叠配置时，第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174中的每一个被配置成在顺时针方向和逆时针方向中的每一个上与两个相邻的密封区段部分重叠。更具体地，第一密封区段164被配置成在顺时针方向上与第六和第五密封区段174、172部分重叠并且在逆时针方向上与第二和第三密封区段166、168部分重叠，第二密封区段164被配置成在顺时针方向上与第一和第六密封区段164、174部分重叠并且在逆时针方向上与第三和第四密封区段164、168部分重叠，第三密封区段166被配置成在顺时针方向上与第二和第一密封区段166、164部分重叠并且在逆时针方向上与第四和第五密封区段170、172部分重叠，第四密封区段170被配置成在顺时针方向上与第三和第二密封区段168、166部分重叠并且在逆时针方向上与第五和第六密封区段172、174部分重叠，第五密封区段172被配置成在顺时针方向上与第四和第三密封区段170、168部分重叠并且在逆时针方向上与第六和第一密封区段174、164部分重叠，并且第六密封区段174被配置成在顺时针方向上与第五和第四密封区段172、170部分重叠并且在逆时针方向上与第一和第二密封区段164、166部分重叠。
在各方面中，并且如图所示，第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174被折叠，使得第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174在逆时针方向上以顺序模式重叠。可替代地，第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174可折叠以在顺序的顺时针方向上重叠。可以设想的是，第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174可以代替地以相反的对折叠，例如第一和第四密封区段164、170折叠在一起，第二和第五密封区段166、172折叠在一起，并且第三和第六密封区段168、174折叠在一起，或以任何其它合适的方式折叠。
如图所示，密封组件160的相应的第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174的内边缘164b、166b、168b、170b、172b、174b可限定V形，或可笔直延伸。在各方面中，V形限定从约一百八十度(180°)至约二百七十五度(275°)的角度“α”。内边缘164b、166b、168b、170b、172b 164b的V形有助于穿过密封组件160接纳手术器械(未示出)。
第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174中的每一个限定多个开口165、167、169、171、173、175，其分别与每个密封区段164、166、168、170、172、174的相应的连接器部分164a、166a、168a、170a、172a、174a相邻。在各方面中，并且如图所示，多个开口165、167、169、171、173、175被布置成使得支撑构件162中的多个开口163的每个开口与相应的第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174的多个开口165、167、169、171、173、175的开口对齐，并且与两个相邻的第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174的多个开口165、167、169、171、173、175的开口对齐。以这种方式，当第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174在组装状态下相对于彼此固定时，保持器组件180的多个销186(图3)中的每一个销穿过支撑构件162中的开口163并且穿过六个密封区段164、166、168、170、172、174中的三个中的开口165、167、169、171、173、175被接纳。这种布置确保密封组件160的完整性，并且更具体地，确保第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174相对于彼此和支撑构件162定位。
继续参考图4，密封组件160包括将第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174互连的多个桥176a-f。多个桥176a-f在第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174的相邻侧边缘164c、166c、168c、170c、172c、174c之间连续地延伸，使得第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174连接在一起并且彼此不独立移动。更具体地，第一和第二密封区段164、166通过桥176a互连，第二和第三密封区段166、168通过桥176b互连，第三和第四密封区段168、170通过桥176c互连，第四和第五密封区段172、174通过桥176d互连，第五和第六密封区段174、176通过桥176e互连，并且第六和第一密封区段176、164通过桥176f互连。在将第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174抵靠支撑构件162折叠之前，将多个桥176a-f切断(例如，使其不连续)，使得第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174可彼此独立移动。
密封组件160包括从第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174中的每一个延伸的多个支座178a-c。多个支座178a-c为密封组件160厚度增加的局部区域，例如，支座178a-c的厚度大于支撑构件162、第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174和多个桥176a-f的厚度，使得当多个密封组件160彼此相邻设置(例如，堆叠在一起)时，支撑构件162和相邻的密封组件160的第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174彼此间隔开。在各方面中，多个支座178a-c为从第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174中的每一个向外延伸的突起。虽然支座178a-c被示出为具有圆形形状，但是支座178a-c的形状可变化，只要支座178a-c不干扰密封组件160的功能，如下文另外所述。
多个支座178a-c从与连接器部分164a、166a、168a、170a、172a、174a和/或内边缘164b、166b、168b、170b、172b、174b相邻的第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174的侧边缘164c、166c、168c、170c、172c、174c延伸。多个支座178a-c设置在第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174中的每一个上的相同位置中。在各方面中，并且如图所示，第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174中的每一个包括在与连接器部分164a、166a、168a、170a、172a、174a相邻的两个侧边缘164c、166c、168c、170c、172c、174c上的支座178a、178b和在与内边缘164b、166b、168b、170b、172b、174b相邻的侧边缘164c、166c、168c、170c、172c、174c中的一个上的支座178c。多个支座178a-c定位于第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174中的每一个上，使得在折叠状态下(图5)，多个支座178a-c设置在密封组件160的外部端子边缘160a周围，即远离密封组件160的功能区域。
在制造密封组件160的方法中，密封组件160由单一或通用材料(例如，聚异戊二烯或液体硅酮橡胶)模制，使得密封组件160被整体地形成，如图4所见。然后将密封组件160放入处理浴(例如，氯化浴)中，以降低密封组件160的粘性并且减小形成密封组件160的材料的摩擦系数。此过程部分地有助于密封组件160的处置和组装，并且部分地有助于密封组件160的功能。
在各方面中，多个密封组件160被放置到处理浴中(例如，密封组件160被堆叠在一起)。密封组件160中的每一个的多个桥176a-f防止第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174彼此分离并且在处理过程期间与其它密封组件160的第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174互锁。密封组件160中的每一个的多个支座178a-c通过维持在密封组件160的表面之间的空间来防止密封组件160彼此粘附。以这种方式，多个桥176a-f和多个支座178a-c确保对整个密封组件160进行处理(例如，暴露于氯化)。
在对密封组件160进行处理并且根据需要另外加工(例如，消毒)之后，切割密封组件160的多个桥176a-f，并且折叠密封组件160。
为了折叠密封组件160，第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174中的每一个在相应的连接器部分164a、166a、168a、170a、172a、174a处相对于支撑构件162折叠。第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174可同时折叠，其中相邻的密封区段彼此重叠。更具体地，第二密封区段166与第一密封区段164重叠，第三密封区段168与第二密封区段166重叠，依此类推，直到第一密封区段164与第六密封区段174重叠。这种重叠或交织模式增加密封组件160的完整性，即，当穿过其接纳手术器械时，减小密封组件160泄漏的可能性。如上所述，可替代地，密封区段可以任何方式折叠，包括将相对的密封区段折叠在一起。
在折叠状态中，第一、第二、第三、第四、第五和第六密封区段164、166、168、170、172、174设置在支撑构件162的密封部分162b附近，并且多个支座178a-c定位在折叠的密封组件160的外部端子边缘160a周围。
图6说明组装的阀组件120的底部视图。密封组件160通过保持器组件180相对于定心机构130和防护组件140(图3)固定。更具体地，从保持器组件180的上部保持器构件182(图3)延伸的多个销186延伸穿过防护组件140、定心机构130和密封组件160，并且被固定在下部保持器构件184的开口185内。在各方面中，多个销186被焊接、胶合、粘合、粘结或以其他方式固定在下部保持器构件184中的多个开口185内，以将上部保持器构件182和下部保持器构件184固定在一起。下部保持器构件184可以代替地或另外包括多个销(未示出)，其中上部保持器构件182限定多个对应开口(未示出)。上部保持器构件182和下部保持器构件184中的任一个或两个可包括用于接合多个销186并且将上部保持器构件182固定到下部保持器构件184的锁定特征(未示出)。
虽然已在图式中示出本公开的各方面，但并不旨在将本公开限制于此，因为旨在使本公开与本领域所允许的范围一样广泛并且应以同样的方式阅读本说明书。因此，应理解，本公开不限于所描述的精确方面并且本领域的技术人员可在不脱离本公开的范围或精神的情况下实现各种其它变化和修改。因此，上文的描述不应解释为限制性的，而仅仅是作为本公开的方面的例证。因此，本公开的范围应当由所附权利要求和其合法等同物确定，而不是由给出的实例确定。

Claims (18)

1.一种制造用于手术进入组件的密封组件的方法，其包含：
形成具有整体构造的密封组件，所述密封组件包括：
支撑构件；
连接到所述支撑构件的密封区段；
设置在相邻的密封区段之间并且使所述相邻的密封区段互连的桥；和
从每个密封区段延伸的多个支座；
将所述密封组件放置到处理浴中；
切割所述桥；和
折叠所述密封组件。
2.根据权利要求1所述的方法，其中形成所述密封组件包括由通用材料模制所述密封组件。
3.根据权利要求1所述的方法，其中将所述密封组件放置到处理浴中包括将所述密封组件放置到氯化浴中。
4.根据权利要求1所述的方法，其中将所述密封组件放置到所述处理浴中包括将多个密封组件放置到所述处理浴中。
5.根据权利要求1所述的方法，其另外包括在切割所述桥之前，从所述处理浴中移除所述密封组件。
6.根据权利要求1所述的方法，其中折叠所述密封组件包括将所述密封区段定位在所述支撑构件附近。
7.根据权利要求6所述的方法，其中定位所述密封区段包括使所述密封区段以顺序模式重叠。
8.一种用于手术进入组件的密封组件，其包含：
支撑构件；
连接到所述支撑构件的密封区段；
设置在相邻的密封区段之间的桥；和
从每个密封区段延伸的多个支座，
所述密封组件具有其中所述密封区段从所述支撑构件径向向外延伸的基本上平面的展开状态和其中所述密封区段定位在所述支撑构件附近的折叠状态。
9.根据权利要求8所述的密封组件，其中所述密封区段包括第一、第二、第三、第四、第五和第六密封区段。
10.根据权利要求9所述的密封组件，其中所述支撑构件为六边形的。
11.根据权利要求8所述的密封组件，其中在所述折叠状态下，每个密封区段在顺时针方向和逆时针方向中的每一个上与两个相邻的密封区段重叠。
12.根据权利要求8所述的密封组件，其中所述支撑构件限定穿过其中的中心开口，并且在所述折叠状态下，所述密封区段的内边缘限定具有不连续的密封圆周的开口，所述开口与所述支撑构件的所述中心开口同心。
13.根据权利要求12所述的密封组件，其中每个密封区段的所述内边缘为基本上V形的。
14.根据权利要求8所述的密封组件，其中每个密封区段通过连接器部分连接到所述支撑构件，每个连接器部分包括活动铰链以准许相对于所述支撑构件折叠相应的密封区段。
15.根据权利要求8所述的密封组件，其中当所述密封组件处于所述展开状态时，所述桥在相邻的密封区段之间连续地延伸，使得所述密封区段互连，并且当所述密封组件处于所述折叠状态时，所述桥在相邻的密封区段之间中断，使得所述密封区段彼此独立。
16.根据权利要求8所述的密封组件，其中所述多个支座为材料的局部区域，所述局部区域的厚度大于所述支撑构件、所述密封区段和所述桥的厚度。
17.根据权利要求8所述的密封组件，其中所述多个支座从每个密封区段的侧边缘延伸，并且当所述密封组件处于所述折叠状态时，所述多个支座设置在所述密封组件的外部端子边缘处。
18.根据权利要求17所述的密封组件，其中所述多个支座设置在每个密封区段上的相同位置。
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