CN1788691A - 套管针密封组件 - Google Patents

套管针密封组件 Download PDF

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CN1788691A
CN1788691A CNA2005101301882A CN200510130188A CN1788691A CN 1788691 A CN1788691 A CN 1788691A CN A2005101301882 A CNA2005101301882 A CN A2005101301882A CN 200510130188 A CN200510130188 A CN 200510130188A CN 1788691 A CN1788691 A CN 1788691A
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CN100522088C (zh
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马克·S·蔡纳
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Ethicon Endo Surgery Inc
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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
    • 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
    • A61B17/3462—Trocars; Puncturing needles with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals
    • 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
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T137/00—Fluid handling
    • Y10T137/7722—Line condition change responsive valves
    • Y10T137/7837—Direct response valves [i.e., check valve type]
    • Y10T137/7879—Resilient material valve
    • Y10T137/788—Having expansible port
    • Y10T137/7882—Having exit lip
    • Y10T137/7885—Multiple slit

Abstract

一种适于与套管针组件配合使用的密封组件，其包括多个密封片，每个密封片包括一外周边缘和一接缝边缘。每个密封片还包括一第一部分和一第二部分，并且一垂直壁以使第一部分相对于第二部分移位的方式连接第一部分和第二部分，从而使第一密封片的第一部分可被置于第二密封片的第二部分上，并且第一密封片和第二密封片的第一部分位于同一平面中，第一密封片和第二密封片的第二部分位于同一平面中。密封片以交叠编织的方式组装，以提供完整的密封体，而不需要第二密封件。

Description

套管针密封组件
技术领域
本发明涉及一种套管针组件。更特别地，本发明涉及一种套管针密封组件。
背景技术
套管针组件是一种手术器械，其用于获得对体腔的接触。套管针组件通常包括两个主要组成元件：由套管针外壳和套管针插管构成的套管针套管以及套管针闭塞器。套管针插管直接穿过皮肤接触体腔，并且套管针闭塞器插在套管针插管中。一旦接触到体腔，就可进行腹腔镜或者关节镜手术以及内窥镜过程。为了刺穿皮肤，将套管针插管的远端置于事先用手术刀割开的皮肤上。然后用套管针闭塞器刺穿皮肤并进入体腔。通过对套管针闭塞器的近端施加压力，迫使套管针闭塞器锋利的尖端穿过皮肤，直至进入体腔。套管针插管通过由套管针闭塞器形成的穿孔插入，并将套管针闭塞器撤回，而将套管针插管留下作为进入体腔的路径。
套管针插管的近端部分通常与套管针外壳连接，套管针外壳限定了一腔室，该腔室具有与由套管针插管所限定的内腔连通的开放远端部分。套管针闭塞器或者其它细长的手术器械或工具通过由套管针外壳限定的腔室的近端部分沿轴向延伸进入并从套管针插管撤回。
目前的套管针组件通常设计为具有一定位于套管针外壳的腔室中的密封机构。所述密封机构通常为密封垫圈或衬垫，套管针闭塞器或其它器械穿过其延伸。密封机构密封被插入器械的外表面，并由此防止流体和吹入的气体经套管针插管和套管针外壳流出或进入体腔。需要这种密封件相对于被插入装置提供优异的抗扯强度、抗刺扎性(resistance to snagging)以及低摩擦。
将密封组件设计为在器械插入前和器械移除后能保持密封。结果，许多套管针组件提供了双重密封系统。也就是说，当有工具/器械通过其插入时，采用顶部或近侧密封件来密封该工具/器械的周围，当没有器械存在时，在顶部密封件的下面设置用于密封套管针外壳的鸭嘴密封件。
相反，另一些套管针组件采用单个密封机构。这些套管针密封组件中的许多种简单地采用具有比与套管针组件协同使用的最小工具/器械略小的小孔的硅树脂密封件。这种类型的密封件经常被指为唇形密封件。将不同直径的手术器械穿过该唇形密封件。如此一来，常常需要这些密封件提供用于器械尺寸的整个范围的密封。因此，相对于最大直径的器械来说，这些密封件的开孔直径很小。
事实上，将唇形密封件推压至400％的应变并不罕见。通过迫使这些直径较大的器械穿过直径相对较小的唇形密封件，这些直径较大的器械会经受作用于器械轴上的法向力的极大的增加。这些增大的力会使外科医生感受到增大的拖拽力或对器械插入/移动的拉力。另外还需要在密封件被拉伸至其极限时，密封件的材料特性能够使其不开裂或撕裂。
发明内容
因此，目前需要一种能够克服现有技术的不足的改进的套管针密封组件。本发明通过提供这样一种密封组件来克服这些不足，所述密封组件消除了与现有技术密封件相关联的周向应力/高应力问题，并且本发明提供了一种密封组件，其既可与单个密封组件一起使用(减小了套管针组件的整体复杂性)，也可作为多重密封系统中的外衬垫。
因此，本发明的一个目的在于提供一种适于与套管针组件协同使用的密封组件。该密封组件包括多个密封片，每个密封片包括一外周边缘和一接缝边缘。每个密封片还包括一第一部分和一第二部分，并且垂直壁以使第一部分相对于第二部分移位的方式连接第一部分和第二部分，从而使第一密封片的第一部分可置于第二密封片的第二部分上，并使第一和第二密封片的第一部分位于同一平面中，使第一和第二密封片的第二部分位于同一平面。密封片以交叠编织的方式(overlapping woven arrangement)组装，以提供不需要第二个密封件的完全密封体。
本发明的另一目的在于提供一种套管针组件，其包括：具有近端及远端的套管针插管；以及套管针外壳，该套管针外壳与套管针插管的近端相连，以容纳并导引闭塞器穿过套管针插管。该套管针外壳包括一开口的近端部分，其限定了一为上述密封组件配备的开口。
本发明的又一目的在于提供一种套管针组件，其包括：具有近端及远端的套管针插管；以及套管针外壳，该套管针外壳与套管针插管的近端相连，以容纳并导引闭塞器穿过套管针插管。套管针外壳包括一开口的近端部分，其限定了一为近侧密封组件和远侧密封组件配备的开口。近侧密封组件包括多个密封片，每个密封片具有一外周边缘和一接缝边缘。每个密封片还包括一第一部分和一第二部分，并且一垂直壁以使第一部分相对于第二部分移位的方式连接第一部分和第二部分，从而使第一密封片的第一部分可置于第二密封片的第二部分上，并使第一和第二密封片的第一部分位于同一平面中，使第一和第二密封片的第二部分位于同一平面中。密封片以交叠编织的方式组装，以提供不需要第二密封件的完整密封体。
(1)本发明涉及一种适于与套管针组件配合使用的密封组件，该密封组件包括：多个密封片，每个密封片包括一外周边缘和一接缝边缘；每个密封片还包括一第一部分和一第二部分，并且一垂直壁以使第一部分相对于第二部分移位的方式连接第一部分和第二部分，从而使第一密封片的第一部分可被置于第二密封片的第二部分上，并且第一密封片和第二密封片的第一部分位于同一平面中，第一密封片和第二密封片的第二部分位于同一平面中；其中，密封片以交叠编织的方式组装，以提供完整的密封体，而不需要第二密封件。
(2)根据第(1)项所述的密封组件，其中组装四个密封片以形成密封组件。
(3)根据第(1)项所述的密封组件，其中每个密封片基本上为半圆形。
(4)根据第(1)项所述的密封组件，其中每个密封片的外周边缘限定了一个大约为180度的弧形。
(5)根据第(1)项所述的密封组件，其中每个密封片的外周边缘包括一系列孔，所述孔用作连接密封片并最终连接密封组件的手段。
(6)根据第(1)项所述的密封组件，其中密封组件包括四个单独的密封片，通过将第一密封片的第一部分放置于第二密封片的第二部分上，第二密封片的第一部分放置于第三密封片的第二部分上，第三密封片的第一部分放置到第四密封片的第二部分上，第四密封片的第一部分放置到第一密封片的第二部分上，将所述的四个密封片以编织布置的方式结合在一起。
(7)根据第(1)项所述的密封组件，其中每个密封片包括一弯曲的中央部分。
(8)根据第(1)项所述的密封组件，其中每个密封片均为交联聚合物构成的弹性体。
(9)本发明涉及一种套管针组件，包括：包括近端和远端的套管针插管；与套管针插管的近端相连的套管针外壳，用于容纳并导引闭塞器穿过套管针插管，该套管针外壳包括一开口的近端部分，所述开口近端部分限定了一为密封组件配备的开口；密封组件包括：多个密封片，每个密封片包括一外周边缘和一接缝边缘；每个密封片还包括一第一部分和一第二部分，并且一垂直壁以使第一部分相对于第二部分移位的方式连接第一部分和第二部分，从而使第一密封片的第一部分可被置于第二密封片的第二部分上，并且第一和第二密封片的第一部分位于同一平面中，第一和第二密封片的第二部分位于同一平面中；其中，密封片以交叠编织的方式组装，以提供完整的密封体，而不需要第二密封件。
(10)根据第(9)项所述的套管针组件，其中组装四个密封片以形成密封组件。
(11)根据第(9)项所述的套管针组件，其中每个密封片基本上为半圆形。
(12)根据第(9)项所述的套管针组件，其中每个密封片的外周边缘限定了一个大约为180度的弧形。
(13)根据第(9)项所述的套管针组件，其中每个密封片的外周边缘包括一系列孔，所述孔用作连接密封片并最终连接密封组件的手段。
(14)根据第(9)项所述的套管针组件，其中密封组件包括以四个单独的密封片，通过将第一密封片的第一部分放置于第二密封片的第二部分上，第二密封片的第一部分放置于第三密封片的第二部分上，第三密封片的第一部分放置到第四密封片的第二部分上，第四密封片的第一部分放置到第一密封片的第二部分上，将所述的四个密封片以编织布置的方式结合在一起。
(15)根据第(9)项所述的套管针组件，其中每个密封片包括一弯曲的中央部分。
(16)根据第(9)项所述的套管针组件，其中每个密封片都是交联聚合物构成的弹性体。
(17)本发明涉及一种套管针组件，包括：包括近端和远端的套管针插管；与套管针插管的近端相连的套管针外壳，用于容纳并导引闭塞器穿过套管针插管，该套管针外壳包括一开口的近端部分，该开口近端部分限定了一给近侧密封组件和远侧密封组件配备的开口；所述近侧密封组件包括：多个密封片，每个密封片具有一外周边缘和一接缝边缘；每个密封片还包括一第一部分和一第二部分，并且一垂直壁以使第一部分相对于第二部分移位的方式连接第一部分和第二部分，从而使第一密封片的第一部分可置于第二密封片的第二部分上，并且第一和第二密封片的第一部分位于同一平面中，第一和第二密封片的第二部分位于同一平面中；其中，密封片以交叠编织的方式组装，以提供完整的密封体，而不需要第二密封件。
(18)根据第(17)项所述的套管针组件，其中每个密封片的外周边缘限定了一个大约为180度的弧形。
(19)根据第(17)项所述的套管针组件，其中密封组件包括以四个单独的密封片，通过将第一密封片的第一部分放置于第二密封片的第二部分上，第二密封片的第一部分放置于第三密封片的第二部分上，第三密封片的第一部分放置到第四密封片的第二部分上，第四密封片的第一部分放置到第一密封片的第二部分上，将所述的四个密封片以编织排列的方式结合在一起。
(20)根据第(17)项所述的套管针组件，其中每个密封片基本上为半圆形。
通过下列详细描述，结合解释本发明的一些实施例的附图阅读时，本发明的其它目的和优点将更为明显。
附图说明
图1是采用了按照本发明的近侧密封件的套管针组件的分解图。
图2是采用了按照本发明的近侧密封件的可选套管针外壳的剖视图。
图3是按照本发明的近侧密封件的透视图。
图4是图3中显示的近侧密封件的分解图。
图5是该近侧密封件沿着图3中的线5-5的剖视图。
图6是按照本发明的一种作为选择的近侧密封件的透视图。
图7是该近侧密封件沿着图6中的线7-7的剖视图。
具体实施方式
这里对本发明的详细实施例进行描述。然而，应理解，这些公开的实施例仅仅作为对可采取多种形式体现的本发明的解释。因此，这里公开的细节并不解释为限制，而仅仅作为权利要求书的基础，以及作为教导本领域技术人员如何制备和/或使用本发明的基础。
参照图1-5，公开了套针装置12的近端密封装置10。通过减少隆起(tenting)发生的可能性，密封组件10提供了改进的抗扯强度。如同本领域技术人员理解的那样，当密封件例如通过器械穿过密封件受到拉伸并变薄时，就会发生隆起，由此提供了很容易刺穿的薄弱区域。如同本领域技术人员当然理解的那样，本发明的密封组件10适于与各种套管针组件一起使用。另外，尽管被描述为在双重密封系统中的近侧密封组件，本发明的密封组件10也可用在单个密封系统中。
本发明的密封组件10适于与各种套管针组件(见图1与2)一起使用。例如，密封组件10适于与低成本手术套管针组件一起使用，使用所述手术套管针组件用于微创内窥镜手术过程，包括但不限于腹腔镜和关节镜手术过程。这种手术套管针组件是一次性的，并倾向于一个装置仅仅用于一个患者。
除根据本发明的近侧密封组件10以外，套管针组件12的常规结构不构成本发明的部分。例如为了解释本发明的密封组件10，套管针组件可采用美国专利No.5,827,228、No.5,947,930、No.4,535,773、No.5,224,952、No.5,256,149、No.5,314,417、No.5,387,197、No.5,248,298、No.5,330,437、No.5,399,167、No.5,066,288、No.5,215,526以及No.5,267,965中公开的形式，所有这些申请均通过引用而包含于本申请中。
记住这一点，作为例子，套管针组件12包括套管针插管14、套管针闭塞器16以及套管针外壳(或手柄)18。套管针插管14限定了一内腔，该内腔具有一开口的远端部分和一开口的近端部分。近端部分延伸进入并固定于套管针外壳18的远端部分中。套管针外壳18具有一开口的近端部分，该开口近端部分限定了一开口。在该开口中设置将按照本发明构建并在下面详细描述的近侧密封组件10。该开口中还设置了定位于近侧密封组件10下方的鸭嘴密封组件20。套管针闭塞器16以可滑动并可拆卸的方式在套管针插管14中延伸，并通过密封组件10和套管针外壳18的开口插入到套管针外壳18和套管针插管14中。在套管针闭塞器16的近端设置一闭塞器把手22，并在其远端形成一锋利的尖端或刃23。如同本领域公知的那样，密封组件10与套管针闭塞器16或者另一通过套管针插管14延伸的手术器械协同，以使外表面与套管针插管密封地结合，由此防止流体流经套管针外壳18流动。
参见图3、4及5，公开了密封组件10的一优选实施例。根据本发明的优选实施例，密封组件10由多个交叠的密封片24编织排列组装，以提供完整的密封体，而不需要第二密封件。通过提供多个叠置的密封片24，本发明的密封组件10还将密封组件10与被插入器械之间的泄漏降到最低。如上面所讨论的那样，这里公开的密封组件10作为双重密封系统的近侧密封组件，但是本发明的密封组件很容易用于单个密封系统中。
特别地，布置四个密封片24以形成密封组件10的密封体26。尽管根据本发明的一优选实施例采用了四个密封片24时，密封体26可最终由不同数量的密封片形成，而不背离本发明的精神和范围。
每个密封片24都是半圆形。这些密封片24中的每一个都包括一基本上圆形的外围边缘28和一最终限定了接缝边缘32的直的边缘30。按照本发明的优选实施例，每个密封片24的外周边缘28限定了一个约为180度的弧形。外周边缘28还包括适于定位于套管针外壳18中的凸脊。外周边缘28还包括一系列孔31，所述孔与上部及下部夹持构件(未显示)协同操作，以牢固地连接密封片24并最终完成密封组件10。如同基于下列公开的内容所明确的那样，通过提供采用多个扩展及收缩的密封片24的密封组件10，以围绕套管针闭塞器16或其它从中插入的器械进行密封，限定了大约180度弧形的多个密封片24的使用导致了周向应力的减小。
每个密封片24包括一第一部分38和一第二部分40。垂直壁42连接第一与第二部分38、40。更特别地，每个密封片24的第一部分38和第二部分40以如下方式偏置，即，使第一密封片24的第一部分38可放置在第二密封片24的第二部分40上，并且第一及第二密封片24的第一部分38基本上位于同一平面中，第一及第二密封片的第二部分40也基本上位于同一平面中。
以这种方式，四个单独的密封片24a-d以编织布置的方式结合在一起，以形成一个被完全密封的完整密封体26，而不需要第二密封件。也就是说，通过将第一密封片24a的第一部分38放置于第二密封片24b的第二部分40上来组装密封体26。随后，第二密封片24b的第一部分38放置于第三密封片24c的第二部分40上，第三密封片24c的第一部分38放置到第四密封片24d的第二部分40上，并且第四密封片24d的第一部分38放置到第一密封片24a的第二部分40上。
结合到每个密封片24中的垂直壁42允许进行扩展。特别地，垂直壁42提供了从密封组件10的中央进出口的扩展。这允许密封材料可更大的扩展，并最终使中央开口可更大的扩展。将垂直壁42与第一及第二部分38、40一起使用形成了两个独立的密封表面，它们之间由中空的空气间隔彼此隔开；也就是说，叠置的第一及第二部分38、40用作两个不同的密封表面，尽管事实上所有密封片24都编织在一起形成了单个密封体26。每个密封片24与下一个密封片如此叠置，即，当从密封组件10的顶侧或底侧观察时，每个密封片24都仅仅暴露了90°的表面区域。
根据一可择的实施例，参照图6与图7，对密封体110略微进行修改，在密封体110的中央形成圆锥形的导入面111。该圆锥形导入面111提供了帮助器械进入密封组件110的中央的导引。
特别地，该实施例包括四个交叠的密封片124，它们以编织布置的方式组装形成一个完整的密封体126，而不需要第二密封件。如同前面的实施例，每个密封片124为半圆形。每个密封片124包括一基本上圆形的外周边缘128和一限定了接缝边缘132的直边缘130。按照本发明的优选实施例，每个密封片124的外周边缘128限定了一个约为180度的弧形。外周边缘128还包括一适于定位在套管针外壳118的内壳中的凸脊。外周边缘128还包括一系列孔131，所述孔用作连接密封片124并最终连接密封组件110的手段。如同基于下列公开所明示的那样，限定了大约为180度的弧形的密封片124的使用导致周向应力减小。
每个密封片124包括一第一部分138和一第二部分140。垂直壁142连接第一与第二部分138、140。更特别地，各密封片124的第一部分138和第二部分140以如下方式偏置，即，使第一密封片124的第一部分138可放置在第二密封片124的第二部分140上，并且第一及第二密封片124的第一部分138位于同一平面中，第一及第二密封片124的第二部分140也位于同一平面中。
每个密封片的第一及第二部分138、140都包括一中央弯曲部分139、141。特别地，第一部分138包括一弯曲部分139，当第一部分138从外周边缘128向着垂直壁142与密封片124的直边缘130的汇合点延伸时，弯曲部分139向着第二部分140弯曲。同样地，第二部分140包括一弯曲部分141，当第二部分140从外周边缘128向着垂直壁142与密封片124的直边缘130的汇合点延伸时，弯曲部分141向着第一部分138弯曲。
使用时，如同前一实施例，当将器械插入密封组件110的中央时，密封材料被移到一边。然而，第一与第二部分138、140的弯曲部分用来将器械向着密封组件110的中心引导。
上述两个实施例最终都通过在组装的密封体26、126的顶面和底面使用夹持构件(未显示)将其保持在一起。夹持构件对本领域技术人员来说是公知的，在本发明的精神范围内可采用各种夹持构件。
如同上面简要提到的那样，通过提供按照本发明的密封组件10、110，不再需要第二密封件(即，挡板或者鸭嘴)。此外，本发明的密封组件10、110对材料的要求不那么严格，消除了围绕较大工具的周向应力，减少了密封件撕裂问题并提供了工具/器械的引入(当采用圆锥形表面的实施例时)。
尽管已经示出并说明了优选实施例，但是应当理解，其并不是通过这种公开而对本发明进行限制，而是想要覆盖所有落入如同所附权利要求书中限定的本发明的精神和范围内的结构改变和变化。

Claims (8)

1.一种适于与套管针组件配合使用的密封组件，该密封组件包括：
多个密封片，每个密封片包括一外周边缘和一接缝边缘；
每个密封片还包括一第一部分和一第二部分，并且一垂直壁以使第一部分相对于第二部分移位的方式连接第一部分和第二部分，从而使第一密封片的第一部分可被置于第二密封片的第二部分上，并且第一密封片和第二密封片的第一部分位于同一平面中，第一密封片和第二密封片的第二部分位于同一平面中；
其中，密封片以交叠编织的方式组装，以提供完整的密封体，而不需要第二密封件。
2.根据权利要求1所述的密封组件，其特征在于，组装四个密封片以形成密封组件。
3.根据权利要求1所述的密封组件，其特征在于，每个密封片基本上为半圆形。
4.根据权利要求1所述的密封组件，其特征在于，每个密封片的外周边缘限定了一个大约为180度的弧形。
5.根据权利要求1所述的密封组件，其特征在于，每个密封片的外周边缘包括一系列孔，所述孔用作连接密封片并最终连接密封组件的手段。
6.根据权利要求1所述的密封组件，其特征在于，密封组件包括四个单独的密封片，通过将第一密封片的第一部分放置于第二密封片的第二部分上，第二密封片的第一部分放置于第三密封片的第二部分上，第三密封片的第一部分放置到第四密封片的第二部分上，第四密封片的第一部分放置到第一密封片的第二部分上，将所述的四个密封片以编织布置的方式结合在一起。
7.根据权利要求1所述的密封组件，其特征在于，每个密封片包括一弯曲的中央部分。
8.根据权利要求1所述的密封组件，其特征在于，每个密封片均为交联聚合物构成的弹性体。
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