CN112137692A - 外科手术进入组件用密封组件 - Google Patents

外科手术进入组件用密封组件 Download PDF

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CN112137692A
CN112137692A CN202010543022.8A CN202010543022A CN112137692A CN 112137692 A CN112137692 A CN 112137692A CN 202010543022 A CN202010543022 A CN 202010543022A CN 112137692 A CN112137692 A CN 112137692A
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assembly
seal
seals
surgical access
lower support
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罗伊·皮列特雷
马修·迪尼诺
加勒特·埃伯索尔
凯文·德雅尔丹
贾斯廷·托马斯
雅各布·巴里尔
妮科莱特·拉皮埃尔
埃里克·布朗
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Covidien LP
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    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A61B17/3431—Cannulas being collapsible, e.g. made of thin flexible material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B17/0218—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors for minimally invasive surgery
    • 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
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3474—Insufflating needles, e.g. Veress needles
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3498—Valves therefor, e.g. flapper valves, slide valves
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M39/0606—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof without means for adjusting the seal opening or pressure
    • 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
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B2017/3419—Sealing means between cannula and body
    • 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
    • A61B2017/3464—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 with means acting on inner surface of valve or seal for expanding or protecting, e.g. inner pivoting fingers
    • 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
    • A61B2017/3466—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 for simultaneous sealing of multiple instruments
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M2039/0626—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof used with other surgical instruments, e.g. endoscope, trocar

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Abstract

本发明涉及一种外科手术进入组件用密封组件。本发明的外科手术进入组件包括器械阀壳和布置在器械阀壳的腔内的阀组件。阀组件包括防护组件，与防护组件相邻布置的密封组件，以及用于将密封组件和防护组件保持在器械阀腔内居中的定心机构。密封组件包括多瓣密封构件以及上支撑构件和下支撑构件。上支撑构件和下支撑构件将多瓣密封构件夹在其间，以减少和/或消除通过多瓣密封构件的泄漏。

Description

外科手术进入组件用密封组件
技术领域
本公开涉及包括密封件的用于微创外科手术的外科手术进入组件。更具体地，本公开涉及用于外科手术进入组件的密封件。
背景技术
为了便于微创外科手术，在手术部位处创建工作空间。将通常为CO2的吹入流体导入患者的腹部，以形成一种称为气腹的充气状态。外科手术进入组件用于允许引入手术器械和内窥镜(或其他可视化工具)。这些外科手术进入组件保持气腹压力，因为它们具有一个或多个适于手术器械的密封件。通常，在外科手术进入组件中不存在手术器械的情况下，外科手术进入组件中的“零密封”将外科手术进入组件密封，并且器械密封件围绕已经通过外科手术进入组件插入的手术器械进行密封。
当今市场上的手术器械广泛要求牢固的密封件，该密封件能够适应多种尺寸并且能承受手术器械的多次插入。某些器械可能会包括锋利的边缘，这些边缘会撕裂或损坏密封件。因此，具有改善的密封耐久性的外科手术进入组件将是有益的。
发明内容
提供了具有改善的密封耐久性的外科手术进入组件。外科手术进入组件包括器械阀壳和阀组件，该器械阀壳包括上壳区段、下壳区段和内壳区段并限定腔，该阀组件布置在器械阀壳的腔内。阀组件包括：包括多个防护部的防护组件；与防护组件相邻布置的密封组件；以及用于将密封组件和防护组件保持在器械阀腔内居中的定心机构。密封组件包括多个密封部以及上支撑构件和下支撑构件。多个密封部可从展开构造移动到折叠构造，在折叠构造中，密封组件形成八边形构件，该八边形构件限定了开口以便于手术器械密封地通过。上支撑构件和下支撑构件分别被接收在多个密封部的近侧和远侧，并围绕多个密封部压缩以将多个密封部夹在其间。
在实施例中，上支撑构件和下支撑构件限定约0.30”至约0.45”的开口。上支撑构件和下支撑构件的厚度可为约0.006英寸至约0.015英寸。多个密封部可以由聚异戊二烯或液态硅橡胶形成。多个密封部中的每个密封部可以通过连接器部分连接到多个密封部中的相邻密封部。连接器部分可以包括活动铰链。上支撑构件可以通过连接器部分连接到多个密封部中的一个密封部，下支撑构件可以通过另一个连接器部分连接到多个密封部中的另一个密封部。
在一些实施例中，多个密封部中的每个密封部的内边缘可以限定为V形。V形可以包括约180度至约275度的角度。多个密封部可包括第一密封部、第二密封部、第三密封部和第四密封部，第一密封部、第二密封部、第三密封部和第四密封部中的每一个与相邻的第二密封部、第三密封部、第四密封部和第一密封部重叠。
外科手术进入组件可进一步包括保持器组件，该保持器组件包括上保持器构件和下保持器构件。上保持器构件或下保持器构件中的至少一个可包括可穿过防护组件和密封组件接收的多个销，以将防护组件和密封组件相对于彼此保持。定心机构可以包括波纹管。上支撑构件和下支撑构件可以包括六边形形状。上支撑构件和下支撑构件可以包括八边形形状。
提供一种阀组件，其包括具有改善的耐久性的密封组件。阀组件包括：包括多个防护部的防护组件；与防护组件相邻设置的密封组件；以及用于将密封组件和防护组件保持在器械阀腔内居中的定心机构。密封组件包括多个密封部以及上支撑构件和下支撑构件。多个密封部可从展开构造移动到折叠构造，在折叠构造中密封组件形成八边形构件，其限定了开口以促进手术器械从中密封地通过。上支撑构件和下支撑构件分别布置在多个密封部的近侧和远侧，并且围绕多个密封部压缩以将多个密封部夹在其间。
在实施例中，阀组件还包括具有上保持器构件和下保持器构件的保持器组件。上保持器构件和下保持器构件中的至少一个可包括可穿过防护组件和密封组件接收的多个销，用于将防护组件和密封组件相对于彼此保持。上支撑构件可以通过连接器部分连接到多个密封部中的密封部，下支撑构件可以通过另一个连接器部分连接到多个密封部中的另一个密封部。
提供了一种具有改善的耐久性的密封组件。密封组件包括多个密封部，多个密封部可从展开构造移动到折叠构造，在折叠构造中，密封组件形成八边形构件，其限定了开口以便于手术器械密封地通过，密封组件还包括布置在多个密封部的近侧的上支撑构件和设置在多个密封部的远侧的下支撑构件。上支撑构件和下支撑构件围绕多个密封部压缩以将多个密封部夹在其间。
附图说明
结合在本说明书中并且构成本说明书的一部分的所附附图例示了本公开的实施例，并且与上文所给出的本公开的一般描述和下文所给出的实施例的详细描述一起用以说明本公开的原理，其中：
图1是根据本公开实施例的外科手术进入组件的侧视立体图；
图2是图1所示外科手术进入组件沿剖面线2-2截取的侧视截面图；
图3是图2所示的阀组件的部件分离的立体图，包括定心机构、防护组件、密封组件和保持器组件。
图4是图3所示的密封组件的俯视立体图；
图5是图3所示的密封组件的仰视立体图；
图6是图3所示的密封组件的支撑构件的立体图；
图7是图4所示的密封组件沿剖面线7-7截取的侧视截面图；
图8是根据本公开的另一实施例的密封组件的立体图；
图9是图8所示的密封组件处于展开状态下的俯视图；
图10-14是图8所示的密封组件在连续的部分折叠状态下的立体图；以及
图15是图8所示的密封组件处于完全折叠状态下的立体图。
具体实施方式
下面参照附图描述本外科手术进入组件的特定实施例；然而，应当理解，所公开的实施例仅仅是本公开的示例性实施例，并且可以以各种形式体现。为了避免以不必要的细节模糊本公开，没有对公知的功能或构造进行详细描述。因此，本文公开的具体结构和功能细节不应被解释为限制性的，而仅仅是作为权利要求的基础和作为用于教导本领域技术人员以实际上任何适当的详细结构不同地使用本发明的代表性基础。在关于附图的整个描述中，相同的附图标记表示相似或相同的元件。
如本文所使用的，术语“远侧”是指器械或其部件的较远离使用者的部分，而术语“近侧”是指器械或其部件的较靠近使用者的部分。如本文所使用的，术语“约”是指该数值是近似的，并且小的变化不会显著影响所公开的实施例的实践。在使用数值限制的情况下，除非上下文另外指出，否则“约”是指该数值可以变化±10％并且保持在所公开的实施例的范围内。
在微创外科手术例如腹腔镜手术期间采用外科手术进入组件，并使手术器械密封地进入吹气的体腔例如腹腔中。本公开的外科手术进入组件包括：安装在套管管体上的器械阀壳，并且包含穿过阀壳和套管插入的闭塞器(未示出)。闭塞器可具有钝的远端，或带刀片或无刀片的穿透远端，并且可用于切开腹壁，以便能将外科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在外科手术进入组件的器械阀壳上。
通过形成穿过解剖结构(例如腹壁)的新通道，或通过穿过解剖结构的现有开口，外科手术进入组件能用于隧穿解剖结构。一旦套管针组件已经隧穿解剖结构隧穿，就将套管针闭塞器移除，从而将套管组件留在适当位置。套管的器械阀壳包括阀，该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。
在各种实施例中，可提供无刀片的光学套管针闭塞器，其允许在外科手术过程中分离组织平面，并且在体组织纤维分离时可视化体组织纤维，从而允许控制体组织纤维在体壁上的穿行。在其他实施例中，套管针闭塞器可以是无刀片的但不是光学的，例如，不通过闭塞器的远侧尖端同时提供其可视化。可提供无刀片的闭塞器，以在外科手术过程中对腹壁进行钝性解剖。
适用于本公开的套管的各种套管针闭塞器是已知的，并且包含例如带刀片的、无刀片的、钝的、光学的和非光学的套管针闭塞器。对于包含示范性套管针闭塞器和示范性套管的示例性套管针组件的结构和功能的详细描述，请参见公有的第WO 2016/186905号PCT公开案(“’905公开”)，其内容在此以全文引用的方式并入本文。
现在首先参照图1，根据本公开的方面的外科手术进入组件整体以套管组件100示出。套管组件100包括套管102和固定至套管102的器械阀壳110。对于示例性套管组件的详细论述，请参考‘905公开。
参照图2，套管组件100的器械阀壳110包含上壳区段112、下壳区段114和内壳区段116。上壳区段112、下壳区段114和内壳区段116配置成在套管102的近端支撑阀组件120。更具体地，内壳区段116被固定在上壳区段112和下壳区段114之间，并且阀组件120被接收在内壳区段116和下壳区段114之间。器械阀壳110的上壳区段112和下壳区段114可选择性地附接到内壳区段116以及可从内壳区段116拆卸。下壳区段114可以可释放或永久地附接到套管组件102的套管管体104。在实施例中，器械阀壳110的上壳区段112和下壳区段114中的一个或两个可以包括滚花、凹痕、突片，或以其它方式被配置成方便由临床医生进行接合。
套管组件100还可包括用于稳定外科手术进入组件的特征。例如，套管管体104的远侧可以携带从内侧接合腹部的球囊锚或另一种可膨胀构件。例如，参见美国专利第7,300,448号，其全部公开内容在此以引用的方式并入本文中。腹壁的相对侧上的特征可以用于进一步使外科手术进入组件稳定，例如粘合突片或可调节的泡沫套环。
器械阀壳110的上壳区段112、下壳区段114和内壳区段116限定用于接收手术器械(未示出)的纵向通道111。阀组件120被支撑在器械阀壳110内，以使手术器械密封通过套管组件100。
具体参照图2和3，支撑在器械阀壳110(图2)中的阀组件120包含定心机构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被接收时，阀组件120的定心机构130准许阀组件120相对于器械阀壳110径向地移动，并且另外将阀组件120保持在器械阀壳110内大体上居中的位置。防护组件140在手术器械通过密封组件160插入和抽出的期间保护密封组件160。密封组件160使手术器械密封地通过器械阀壳110。保持器组件180将定心机构130、防护组件140和密封组件160彼此保持在对准关系。
继续参考图2和图3，如上文所提到的，阀组件120的定心机构130被配置成将阀组件120保持为在器械阀壳110(图2)内居中。在实施例中，并且如所示出，定心机构130包括外部环圈132、内部环圈134以及布置在外部环圈132和内部环圈134之间的波纹管136。如图2所示，外部环圈132接收在内壳区段116和下壳区段114之间，以将定心机构130保持在器械阀壳110内。内部环圈134支撑密封组件160。对于示例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，其内容的全文以引用的方式并入本文中。
尽管定心机构130显示为具有波纹管136，但是阀组件120可包括替代的定心机构。例如，定心机构可以包括环形基座和从基座延伸的多个辐条，如公有的美国专利申请第2015/0025477号(’477公开)所述，其内容通过引用全文并入本文。据设想，定心机构可以包括多组辐条，如'477公开中所公开的。
仍参考图2和图3，阀组件120的防护组件140包括环部分142以及第一瓣144、第二瓣146、第三瓣148和第四瓣150。防护组件140可以由塑料/聚合材料片通过用形成环部分142和瓣144、146、148、150的工具冲压而形成。可替代地，防护组件140可以通过模制或其他技术形成。据设想，防护组件可以包括任何数量的瓣，并且瓣可以包括任何尺寸或构造的翼片部分。对于示例性防护组件以及外科手术进入组件的其他方面，请参考美国专利号第5,895,377和6,569,120号，其全部公开内容通过引用并入本文。对于其他示例性防护组件的结构和功能的详细描述，请参考公有的美国专利第16/394,043号、第16/238,823和第##/###,####(Atty.案卷号C00019509.USU1(203-12169)、A0000135US01(203-12267)和C00017498US01(203-12319))，其全部内容通过引用并入本文。
现在继续参考图2和图3，阀组件120的密封组件160构造成在穿过器械阀壳110(图2)的手术器械(未示出)的外表面周围提供密封。
密封组件160包括多瓣或多区段密封构件162，以及上支撑构件164和下支撑构件166。如图所示，多瓣密封构件162包括形成六边形主体并限定开口161的六个瓣或六个区段。尽管示出为包括六(6)个区段，但是据设想，密封组件160可以包括任何合适数量的区段，例如，少至四(4)个区段，或者多至八(8)个区段。通过从多个瓣片中形成多瓣密封构件162的开口161，而不是形成为穿过单个密封构件的连续实心开口，极大地降低了多瓣密封构件162在通过其插入、移除和使用时会撕裂的可能性。尽管示出具有重叠的翼形瓣162a，但是据设想，本公开的方面可以修改为以与具有备选构造和布置的瓣的密封构件一起使用。示例性的多瓣密封构件在2019年2月11日提交的美国专利第16/272,068号中示出和描述，其全部内容并入本文。
特别参考图6，密封组件160的上支撑构件164和下支撑构件166分别包括与多瓣密封构件162的形状相对应的六边形形状，并分别具有开口163、165。尽管示出为具有六边形主体，但是上支撑构件164和下支撑构件166可具有在尺寸和形状上与任何多瓣密封构件(例如，多瓣密封构件162)相对应的主体。开口163、165的尺寸被设置成允许适当地覆盖多瓣密封构件162，同时仍允许在对力的影响最小的情况下通过密封组件160接收较大的手术器械(未示出)。在实施例中，开口163、165的直径可在约0.300至约0.450”的范围内。
上支撑构件164和下支撑构件166可以由聚丁二烯、液态硅橡胶或具有足够拉伸特性的任何其他材料形成。在实施例中，上支撑构件164和下支撑构件166的厚度在0.006英寸至0.015英寸之间。如将在下面进一步详细描述的，上支撑构件164和下支撑构件166围绕多瓣密封构件162形成夹层结构，以减轻多瓣密封构件162内的泄漏路径的影响。
特别参考图7，密封组件160的多瓣密封构件162的多个瓣的重叠层可提供用于吹入流体通过阀组件120泄漏的路径。密封组件160的上支撑构件164和下支撑构件166被构造成减小吹入流体通过多瓣密封构件162泄漏的可能性。更具体地，上支撑构件164和下支撑构件166分别布置在多瓣密封构件162的近侧和远侧，并且被构造成围绕多瓣密封构件162被压缩。通过在上支撑构件164和下支撑构件166之间压缩多瓣密封构件162，可以大大减少和/或消除多瓣密封构件162的层之间的泄漏。上支撑构件164和下支撑构件166还可在通过其插入、操作和移除手术器械期间帮助防止或减少对多瓣密封构件162的损坏。
多瓣密封构件162、上支撑构件164和下支撑构件166中的每一个分别限定了多个开口161a、163a、165a，用于接收从保持器组件180的上保持器构件182延伸的支腿186。
继续参考图7，密封组件160的上支撑构件164布置在防护组件140和定心机构130的内部环圈134之间。多瓣密封构件162布置在内部环圈134的相对侧，并且密封组件160的下支撑构件164邻近多瓣密封构件162设置。保持器组件180的多个支腿186通过定心机构130、防护组件140和密封组件160中的每一个接收，密封组件包括多瓣密封件162、上支撑构件164和下支撑构件166。
保持器组件180的上保持器构件182和下保持器构件184构造成挤压上支撑构件164和下支撑构件166，并且密封组件160夹在其间。以这种方式，在多瓣密封构件162的瓣162a之间存在的任何泄漏都被尺寸上减小或被消除。
阀组件120的保持器组件180(图3)构造成相对于密封组件160固定防护组件140，并将防护组件140和密封组件160固定到定心机构130。保持器组件180包括上保持器构件182和下保持器构件184。如上所述，上保持器构件182包括多个销186。多个销186从上保持器构件182的底表面延伸。多个销186中的每个销被构造成被锁定地接收在下保持器构件184的多个开口185(图3)的一个开口内。在实施例中，多个销186焊接、胶合、粘合、粘结或以其它方式紧固在下保持器构件184中的多个开口185内，以将上保持器构件182和下保持器构件184紧固在一起。替代地，下保持器构件184可以代替地或另外包括多个销(未示出)，其中上保持器构件182限定多个对应的开口(未示出)。上保持器构件182和下保持器构件184中的任一个或两个可以包括用于接合多个销并将上保持器构件182紧固到下保持器构件184的锁定特征(未示出)。
上保持器构件182的多个销186延伸穿过防护组件140的环部分142，穿过各个多瓣密封构件162中的开口163a、165a、167a以及密封组件160的上支撑构件164和下支撑构件166，通过定心机构130的内部环圈134，并进入下保持器构件184中的开口185。
在利用套管组件100的外科手术过程中，手术器械(未示出)通过上壳区段112、下壳区段114、内壳区段116中的纵向通道113被引入器械阀壳110中。如上所述，手术器械的远端与防护组件140接合，从而使防护组件140的翼片部分向下弯曲以与密封组件160的多瓣密封构件162接触，从而引起多瓣密封构件162的中央开口163打开以容纳手术器械通过密封组件160的通道。通过以夹层方式围绕多瓣密封构件162压缩密封组件160的上支撑构件164和下支撑构件166，减少和/或消除了通过多瓣密封构件162的泄漏。
现在参考图8至图15，根据本发明的另一实施例的密封组件被总体上示出为密封组件260。密封组件260可与本文以上描述的密封组件160互换，并且将仅关于其之间的差异进行详细描述。
特别参考图9，密封组件260包括多个密封部262、上支撑构件264和下支撑构件266。多个密封部262以及上支撑构件264和下支撑构件266彼此固定。在实施例中，并且如图所示，密封组件260整体形成，即一件式或整体式。密封组件260可以被冲压、模制或以其他方式形成。
密封组件260的多个密封部262包括第一部分262a、第二部分262b、第三部分262c和第四部分262d。尽管仅示出了四(4)个部分，但是据设想，密封组件260可以包括多达八(8)个部分。密封组件260的多个密封部262以及上支撑构件264和下支撑构件266可以由相同或不同的材料形成。在实施例中，至少多个密封部262由弹性材料形成，例如橡胶、聚异戊二烯或硅酮弹性体。在实施例中，第一部分262a、第二部分262b、第三部分262c和第四部分262d可包括一个或多个织物层。
密封组件260的多瓣密封构件262的第一部分262a、第二部分262b、第三部分262c和第四部分262d以及上支撑构件264和下支撑构件266中的每一个均包括八边形形状，尽管预期其他形状也可以。密封组件260的相应的第一部分262a、第二部分262b、第三部分262c和第四部分262d的内边缘268a、268b、268c、268d可以是直的(未示出)，或者如图所示可以限定为V形或燕尾形(cut-away)。在实施例中，V形限定在四十五度(45°)和一百八十度(180°)之间的角度。在实施例中，V形限定九十度(90°)的角度。密封组件260的相应的第一部分262a、第二部分262b、第三部分262c和第四部分262d的内边缘268a、268b、268c、268d的V形便于通过密封组件260接收手术器械(未示出)。多瓣密封构件262的第一部分262a、第二部分262b、第三部分262c和第四部分262d可以形成平坦的密封(如图所示)，或者可以形成圆锥形的密封。
继续参考图9所示，密封组件260的上支撑构件264和第一部分262a通过连接器部分263a彼此连接，密封组件260的第一部分262a和第二部分262b通过连接器部分263b彼此连接，密封组件260的第二部分262b和第三部分262c通过连接器部分263c彼此连接，密封组件260的第三部分262c和第四部分通过连接器部分263d彼此连接，密封组件260的第四部分262d和下支撑构件266通过连接器部分263e彼此连接。在实施例中，密封组件260的连接器部分263a、263b、263c、263d、263e包括活动铰链，或者以其他方式形成以便于各部分和支撑构件的折叠。
第一部分262a、第二部分262b、第三部分262c和第四部分262d中的每一个以及上支撑构件264和下支撑构件266沿着每个部分262a、262b、262c、262d的外周分别限定多个开口265a、265b、265c、265d，并且沿上支撑构件244和下支撑构件246的外周限定多个开口265e、265f。多个开口265a、265b、265c、265d、265e、265f被构造成接收保持器组件180的销186(图7)，以将密封组件260保持在折叠状态并且将密封组件260相对于防护组件140和定心机构130固定。
现在将参考图10至图15描述折叠密封组件260的方法。首先参考图10，在上支撑构件264和第一部分262a之间的连接器部分263a处，上支撑构件264相对于多个密封部262的第一部分262a折叠，如箭头“A”所示，使得上支撑构件264与第一部分262a重叠。以这种方式，多个开口265e在密封组件260的第一部分262a的重叠部分中与多个开口265a对准。
转到图11，密封组件260的第一部分262a在第一部分262a和第二部分262b之间的连接器部分263b处相对于密封组件260的第二部分262a折叠，如箭头“B”所示，使得第一部分262a与密封组件260的第二部分262b重叠。以这种方式，第一部分262a的多个开口265a在密封组件260的第二部分262b的重叠部分中与多个开口265b对准。
参考图12所示，密封组件260的第二部分262a在第二部分262a和第三部分262b之间的连接器部分263c处相对于第三部分262b折叠，如箭头“C”所示，使得第二部分262b与密封组件260的第三部分262c重叠。以这种方式，第二部分262b的多个开口265b在密封组件260的第三部分262c的重叠部分中与多个开口265c对准。
参考图13所示，密封组件260的第三部分262c在第三部分262c和第四部分262d之间的连接器部分263d处相对于密封组件260的第四部分262d折叠，如箭头“D”所示，使得第三部分262c与密封组件260的第四部分262d重叠。以这种方式，第三部分262c的多个开口265c在密封组件160的第四部分168的重叠部分中与多个开口265d对准。
参考图14，密封组件260的第四部分262d在第四部分262d与下支撑构件266之间的连接器部分163e处相对于密封组件260的下支撑构件266折叠，如箭头“E”所示，使得第四部分262d与下支撑构件266重叠。以这种方式，第四部分262d的多个开口265d在下支撑构件266的重叠部分中与多个开口265f对准。
密封组件260以与上述密封组件160类似的方式固定在器械阀壳110(图2)内。密封组件260以类似于密封组件160的方式操作。
尽管本文中已示出和描述本公开的各种实施例，但是对于所属领域的技术人员来说将显而易见，这些实施例仅是通过示例的方式提供的。在不脱离本公开的情况下，所属领域的技术人员现在将想到许多变化、改变和取代。因此，本公开仅由所附权利要求书的精神和范围限制。

Claims (19)

1.外科手术进入组件，包括：
器械阀壳，所述器械阀壳包含上壳区段、下壳区段和内壳区段，并限定腔；以及
阀组件，布置在所述器械阀壳的所述腔内，所述阀组件包含：
防护组件，其包括多个防护部，
密封组件，布置成与所述防护组件相邻，所述密封组件包括多个密封部以及上支撑构件和下支撑构件，所述多个密封部可从展开构造移动到折叠构造，在所述折叠构造中，所述密封组件形成八边形构件，其限定开口，以便于手术器械密封地通过，所述上支撑构件和所述下支撑构件分别布置在所述多个密封部的近侧和远侧，并围绕所述多个密封部压缩以将所述多个密封部夹在其间；和
定心机构，其用于将所述密封组件和所述防护组件保持在所述器械阀的所述腔内居中。
2.根据权利要求1所述的外科手术进入组件，其中，所述上支撑构件和所述下支撑构件限定约0.30”至约0.45”的开口。
3.根据权利要求1所述的外科手术进入组件，其中，所述上支撑构件和下支撑构件的厚度为约0.006英寸至约0.015英寸。
4.根据权利要求1所述的外科手术进入组件，其中，所述多个密封部由聚异戊二烯或液态硅橡胶形成。
5.根据权利要求1所述的外科手术进入组件，其中，所述多个密封部中的每个密封部通过连接器部分连接到所述多个密封部中的相邻密封部。
6.根据权利要求1所述的外科手术进入组件，其中，所述连接器部分包括活动铰链。
7.根据权利要求1所述的外科手术进入组件，其中，所述上支撑构件通过连接器部分连接至所述多个密封部中的一个密封部，并且所述下支撑构件通过另一连接器部分连接至所述多个密封部中的另一密封部。
8.根据权利要求1所述的外科手术进入组件，其中，所述多个密封部中的每个密封部的内边缘限定为V形。
9.根据权利要求8所述的外科手术进入组件，其中，所述V形包括约180度至约275度的角度。
10.根据权利要求1所述的外科手术进入组件，其中，所述多个密封部包括第一密封部、第二密封部、第三密封部和第四密封部，所述第一密封部、第二密封部、第三密封部和第四密封部中的每一个与相邻的第二密封部、第三密封部、第四密封部和第一密封部重叠。
11.根据权利要求1所述的外科手术进入组件，还包括保持器组件，所述保持器组件包括上保持器构件和下保持器构件。
12.根据权利要求11所述的外科手术进入组件，其中，所述上保持器构件和所述下保持器构件中的至少一个包括可穿过所述防护组件和所述密封组件接收的多个销，以将所述防护组件和所述密封组件相对于彼此保持。
13.根据权利要求1所述的外科手术进入组件，其中，所述定心机构包括波纹管。
14.根据权利要求1所述的外科手术进入组件，其中，所述上支撑构件和下支撑构件包括六边形形状。
15.根据权利要求1所述的外科手术进入组件，其中，所述上支撑构件和下支撑构件包括八边形形状。
16.一种阀组件，其包含：
防护组件，包括多个防护部，
密封组件，布置成与所述防护组件相邻，所述密封组件包括多个密封部以及上支撑构件和下支撑构件，所述多个密封部可从展开构造移动到折叠构造，在所述折叠构造中，所述密封组件形成八边形构件，其限定了开口，以便于手术器械密封地通过，所述上支撑构件和所述下支撑构件分别布置在所述多个密封部的近侧和远侧，并围绕所述多个密封部压缩以将所述多个密封部夹在其间；和
定心机构，其用于将所述密封组件和所述防护组件保持在外科手术进入组件的腔内居中。
17.根据权利要求16所述的阀进入组件，还包括保持器组件，所述保持器组件具有上保持器构件和下保持器构件，其中，所述上保持器构件和所述下保持器构件中的至少一个包括可穿过所述防护组件和所述密封组件接收的多个销，以将所述防护组件和所述密封组件相对于彼此保持。
18.根据权利要求16所述的阀进入组件，其中，所述上支撑构件通过连接器部分连接至所述多个密封部中的一个密封部，并且所述下支撑构件通过另一连接器部分连接至所述多个密封部中的另一密封部。
19.一种密封组件，包括：
多个密封部，其可从展开构造移动到折叠构造，在所述折叠构造中，所述密封组件形成八边形构件，其限定开口，以便于手术器械密封地通过；
上支撑构件，布置在所述多个密封部的近侧；和
下支撑构件，布置在所述多个密封部的远侧，所述上支撑构件和所述下支撑构件围绕所述多个密封部压缩以将所述多个密封部夹在其间。
CN202010543022.8A 2019-06-28 2020-06-15 外科手术进入组件用密封组件 Pending CN112137692A (zh)

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CN105662545B (zh) 2014-11-16 2019-04-26 广州迪克医疗器械有限公司 径向密封组件、端密封件及穿刺器
GB201500328D0 (en) * 2015-01-09 2015-02-25 Cannula sealing
US10543018B2 (en) 2015-05-15 2020-01-28 Covidien Lp Surgical access device
CN106137339B (zh) * 2016-08-02 2018-06-29 成都五义医疗科技有限公司 一种改进的褶皱型的穿刺器密封膜
US20190059938A1 (en) 2017-08-28 2019-02-28 Covidien Lp Access apparatus including seal component with protective guards
US10828065B2 (en) 2017-08-28 2020-11-10 Covidien Lp Surgical access system
US11259841B2 (en) * 2019-06-21 2022-03-01 Covidien Lp Seal assemblies for surgical access assemblies

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EP3756594A1 (en) 2020-12-30
AU2020203125A1 (en) 2021-01-21
EP3756594B1 (en) 2022-12-28
CA3079787A1 (en) 2020-12-28
US20200405349A1 (en) 2020-12-31
US11413065B2 (en) 2022-08-16

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