CN101849847A - 用于进入体腔的装置和方法 - Google Patents
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Abstract
本发明提供了用于进入体腔的方法和装置。总的来讲,提供了一种外科进入装置,该装置包括:牵开器,该牵开器形成穿过组织的工作沟槽;密封壳体,所述密封壳体用于密封工作沟槽和/或在插入穿过其中的器械周围形成密封;和挠性悬置构件,该挠性悬置构件能够将密封壳体悬置在体腔内,或者使密封壳体延伸超过牵开器的远端。
Description
相关专利申请的交叉引用
本专利申请要求于2009年4月1日提交的、名称为“AccessDevice”(进入装置)的美国临时申请No.61/165,080的优先权,据此该临时申请的全部内容以引用方式合并于此。
技术领域
本发明涉及外科中用于进入体腔的方法和装置。
背景技术
二十世纪八十年代末,随着腹腔镜胆囊切除术相比传统(开放式)手术的优势变得日益明显,腹腔镜外科手术开始流行。腹腔镜手术公认的优点是缩短术后康复时间、显著减轻术后疼痛和伤口感染以及改善外观效果,这主要是由于腹腔镜外科医生能够利用体壁的较小切口开展手术。
腹腔镜手术通常涉及将外科进入装置(例如,直管状插管或套针套管)插入到腹腔中。将二氧化碳气体充入腹腔以使压力达到约15mmHg通常用于增加用于外科手术操作的内部空间。因此,为了实现充气和持续充气,在将外科器械插入穿过套针套管以从外侧密封体腔之前和之后,均在套针套管内使用各种密封元件来密封其工作沟槽。可根据外科医生的操作和需要将合适的腹腔镜器械(抓紧器、解剖器、手术剪、牵开器等)穿过一个或多个套针套管。然后,外科医生可进行各种诊断操作或治疗操作,诊断操作例如是肉眼检查或切除组织样本用于活检,治疗操作例如是切除息肉或肿瘤或重组组织。
由于微创外科手术逐渐流行,所以腹腔镜手术及其所用的器械已得到了显著发展。例如,在一些手术中,肚脐处的单一切口能够足以使得进入外科手术位置。这是由于在腹腔镜手术中肚脐可以是进入腹腔的优选方式。肚脐上的切口可容易地扩大,而不会明显影响术后美观,也不会显著增加伤口并发症的几率,从而可通过放入切口中的单个进入装置引入多个器械。
目前单一切口位置腹腔镜手术中所用的装置通常设置多个密封件,以同时容纳多个外科器械。通常在与腹壁同高的高度处将密封件设置在进入装置内,或者在适当高出体壁处将密封件固定到进入装置。结果,密封件的运动范围受进入装置限制,从而极大地限制了插入穿过其中的外科器械的象限之间可到达的范围。当切口本身在延伸到进入装置下方但是没有延伸穿过腹壁的密封件周围闭合并阻碍通过密封件插入外科器械时,使这些密封件伸缩。
因此,仍需要在切口不使密封件伸缩时提供器械运动范围的方法和装置。
发明内容
本发明提供了用于进入体腔的方法和装置。总的来讲,提供了一种外科进入装置,该装置包括:牵开器,该牵开器形成穿过组织的工作沟槽;密封壳体,该密封壳体密封工作沟槽和/或在插入穿过其中的器械周围形成密封;和悬置构件或拴系件,该悬置构件或拴系件能够将密封壳体悬置在体腔内。
在一个示例性实施例中,可通过与牵开器连接的挠性拴系件将密封壳体悬置在牵开器的工作沟槽内,使得密封壳体的至少一部分能够向远侧延伸超过牵开器的远端,并可相对于牵开器成一定角度地定向。密封壳体可在牵开器的整个工作沟槽上形成密封,并可包括置于其中的一个或多个密封元件,这些密封元件密封工作沟槽和/或在被插入穿过密封元件的器械周围形成密封。
悬置构件或拴系件可具有各种构造。在一个实施例中,挠性拴系件可包括近侧壳体,其与挠性牵开器上的牵开器壳体可旋转地连接。在另一个实施例中,挠性拴系件可包括近侧凸缘,其抵靠牵开器的近端。牵开器从壳体或凸缘延伸的远侧部分可以是挠性的,并且它可包括用于容纳密封壳体的特征。例如,挠性拴系件的远侧部分可包括能够与密封壳体可拆卸地接合的接合结构,例如,环形边缘或凸缘或者套管。
在另一个实施例中,外科进入装置可包括牵开器,其具有近端、远端和延伸穿过其中的工作沟槽。近端能够与患者组织的外表面相邻,远端能够延伸到体腔中,使得工作沟槽提供穿过组织的通路。进入装置还可包括悬置构件,其近端能够与牵开器的近端连接,其远端延伸穿过牵开器的工作沟槽。密封壳体可被设置在悬置构件的远侧部分内,并且它可具有置于其中的至少一个密封元件,这些密封元件能够在从穿过其中的器械周围形成密封。悬置构件的至少一部分可以是挠性的,使得密封壳体能够延伸超过牵开器的远端。
牵开器也可具有任何数量的构造、形状和尺寸。在一个实施例中,牵开器可以是中空的挠性圆柱形构件,其中间部分的最大直径小于牵开器的近端和远端的最大直径。中间部分能够定位于组织中的开口内,近端和远端能够使所述近端和远端之间的组织接合。
悬置构件或拴系件可具有任何数量的构造、形状和尺寸,并可由任何数量的材料形成。在一个实施例中,悬置构件或拴系件的近侧部分可包括径向向外延伸的凸缘,其能够抵靠牵开器的近端。在另一个实施例中,悬置构件或拴系件的近侧部分可包括与牵开器的近端上的壳体配合的卡圈。悬置构件或拴系件的远侧部分还可具有各种构造,但是在一个实施例中,悬置构件的远侧部分为挠性套管的形式。挠性套管的远端可包括用于接合密封壳体的各种特征。在一个实施例中,悬置构件的远侧部分可包括可拆卸地接合密封壳体的接合结构。接合结构可以是(例如)可以接合密封壳体或者将密封壳体保持在悬置构件的远侧部分内的环形构件或边缘。
密封壳体还可具有任何数量的构造、形状和尺寸,并且它可由任何数量的材料形成。在示例性实施例中,密封壳体能够在牵开器的整个工作沟槽上形成密封。密封壳体可包含一个或多个密封元件,这些密封元件能够在器械周围形成密封和/或密封工作沟槽。
在另一个实施例中,提供一种用于进入体腔的方法,该方法可包括以:将挠性牵开器定位在组织内,使得挠性牵开器的工作沟槽形成穿过组织并进入到体腔中的通路。所述方法还可包括:将外科器械插入穿过密封壳体中的密封元件,以将外科器械的远端定位在体腔中,密封壳体通过在密封壳体和挠性牵开器的近侧部分之间延伸的挠性拴系件而悬置在体腔内。可操纵外科器械使密封壳体相对于挠性牵开器移动,从而使挠性拴系件挠曲。可从牵开器移除挠性拴系件和密封壳体,使得得将牵开器留置在组织内。还可将第二外科器械插入穿过密封壳体中的第二密封元件,以将第二外科器械的远端定位在体腔中。
附图说明
通过以下结合附图的具体实施方式部分,将更完整地理解本发明,其中:
图1是外科进入装置的一个示例性实施例的分解透视图;
图2是图1所示装置经组装后的透视剖视图;
图3是图2中的装置置于组织开口中的侧面剖视图;
图4是置于组织中形成的开口中的外科进入装置的另一个示例性实施例的侧面剖视图;
图5是图4中的装置的侧面剖视图,此时,外科器械从图4中的装置穿过;
图6是外科进入装置的另一个示例性实施例的分解透视图;
图7A是密封壳体的一个实施例的分解图;
图7B是图7A中的装置的内壳体的底部透视图;
图7C是图7A中的装置的内壳体的顶部透视图;
图7D是图7A中的装置的器械沟槽构件的顶部透视图;
图8是外科进入装置的另一个示例性实施例的俯视图;
图9是置于组织中形成的开口中的图7中的装置的侧面剖视图;和
图10是外科进入装置的另一个示例性实施例的侧面剖视图。
具体实施方式
现在将描述一些示例性实施例来提供对本文公开的所述装置和方法的结构、功能、制造和使用原理的综合理解。这些实施例中的一个或多个例子在附图中示出。本领域普通技术人员应当理解文中具体描述并用附图示出的装置与方法均为非限制的示例性实施例,且本发明的范围仅由权利要求书规定。结合一个示例性实施例示出或描述的特征可与其他实施例的特征组合。这种修改形式和变型形式旨在包括在本发明的范围内。
提供用于进入体腔的各种示例性方法和装置。总的来讲,本文所述进入装置和方法可用于微创手术(例如腹腔镜手术),并可提供用于微创外科手术的外科器械的改进的运动范围。所述装置可具有许多不同的构造,但是在某些示例性实施例中,进入装置大致可包括:牵开器,其能够形成穿过组织并进入到体腔中的工作沟槽;密封壳体,其内具有至少一个密封件,这些密封件用于密封工作沟槽和/或在插入穿过其中的器械周围形成密封;和悬置构件或拴系件(tether),其能够将密封壳体悬置在体腔内。使用时,可将一个或多个外科器械插入穿过密封壳体中的密封件,从而穿过牵开器的工作沟槽,以将外科器械的远端定位在体腔中。悬置构件可使密封壳体相对于牵开器移动和/或偏离一定角度。悬置构件的这种自由漂浮移动使得可在密封件和插入穿过该密封件的器械之间保持密封接合。本领域技术人员将会知道,进入装置可用于任何外科手术,包括开放性手术,并且进入装置可具有各种其它构造并可包括本领域已知的各种其它特征。而且,本文所公开的悬置构件可用在各种其它装置中用于悬置壳体,使得得壳体可以进行自由角度定位。
图1至图3示出外科进入装置100的一个示例性实施例,该外科进入装置100具有牵开器20、密封壳体60和悬置构件或拴系件40。通常,牵开器20能够被设置在组织内以形成穿过组织并进入到体腔中的工作沟槽28,并且可使悬置构件40位于牵开器20的工作沟槽28内,以用于将密封壳体60保持在牵开器20的远端的远侧位置上,从而将密封壳体60悬置在体腔中。悬置构件40的至少一部分可以是挠性的,使得得可相对于牵开器20将密封壳体60定位在各种角度方位。
本领域技术人员将会知道,至少部分根据牵开器将所处的切口或开口的尺寸、将使用牵开器的外科部件和将使用牵开器的外科手术的类型,牵开器20可具有任何数量的构造、形状和尺寸。虽然本文一般称为牵开器,但是本文所述的各种外科进入装置和方法的牵开器20可以是伤口保护器、插管、环形牵开器或者能够形成穿过组织的通路的任何其它构件。牵开器20可提供进入体腔内的内部外科手术位置的入路,并可包括近端和远端以及在近端和远端之间延伸的工作沟槽28。在示例性实施例中,将牵开器20定位在组织中的开口内,使得牵开器20的远端延伸到患者的体腔中或者与组织的内表面相邻,并使近端与患者身体外表面上的患者皮肤相邻。工作沟槽28提供穿过组织的通路,可从身体外部将外科器械插入穿过该通路进入到内部体腔。可将牵开器20放在患者身体的任何开口中,而不论是天然孔口还是切割而成的开口。例如,可经阴道或皮肤将牵开器20穿过肚脐。
在一个示例性实施例中,如图1至图3所绘,牵开器20包括近侧凸缘22、远侧凸缘24和在近侧凸缘22和远侧凸缘24之间延伸的圆柱形中间部分26。近侧凸缘22和远侧凸缘24可相对于中间部分26的纵轴径向向外延伸,使得凸缘22和24的直径相对于中间部分增大。如图3所示,当将牵开器20放在组织中时,可将近侧凸缘22设置在体壁10的外部,并且近侧凸缘22可与患者皮肤的外表面12接合,可将远侧凸缘24设置在患者内(例如患者的腹腔内),并且当在外科手术期间定位远侧凸缘24时,远侧凸缘24可与患者的体壁10的内表面14接合,并且可将中间部分26设置在组织壁内。
牵开器20的近端和远端可具有可将牵开器20固定在切口内的任何合适的构造。近侧凸缘22和远侧凸缘24被描绘为环形形状,但是它们可具有任何构造,包括(但不限于)圆形、卵形、椭圆形、正方形和矩形构造。另外,近侧凸缘22和远侧凸缘24不必闭合或连续,但是可以(例如)包括多个沿周向间隔、径向延伸的突出部。
如图1至图3所示,近侧凸缘22和远侧凸缘24之间延伸的圆柱形中间部分26限定具有圆形剖面形状的工作沟槽28。当将牵开器20定位在组织中时,圆柱形中间部分26的外表面可与患者的体壁10的至少一部分接合。皮肤的自然弹性将使得紧靠中间部分26的外表面的皮肤被压缩,还可有助于将牵开器20保持在身体开口或切口中。虽然工作沟槽28可具有任何剖面形状,包括(但不限于)圆形、卵形、椭圆形、正方形和矩形,但是圆形工作沟槽可提供每周长单位的最大面积。圆形工作沟槽28还可使得悬置构件40和/或密封壳体60容易相对于牵开器20旋转。
牵开器20可具有各种尺寸。对于非限制性实例,牵开器20的纵向长度可以为约2cm至约7cm之间,其最大直径与近端和远端的直径相应,可以为约40mm至约80mm,其工作沟槽直径可以为约15mm至约40mm之间。外科医生可根据(比如)将进行的手术和切口的尺寸来选择合适尺寸的牵开器。对于非限制性实例,外科医生可选择长度约等于体壁10的厚度的牵开器20来帮助保持牵开器20和体壁10之间的气密密封。还应该理解,近端和远端的直径可以不同,使得牵开器20的远端的直径可大于近端的直径,或者反之亦然。还应该理解,工作沟槽28的直径不必恒定,可沿着其纵向长度而变化。在一个实施例中,小于容许用户的手从其通过所需的且大体小于约50mm的工作沟槽28可以是理想的,从而允许多个器械进入而不要求相对大的切口。或者,牵开器20可具有直径足以容许用户的手从其通过的工作沟槽28。
牵开器20可以是刚性的、半刚性的或挠性的。不止一种的材料可用于形成牵开器20,牵开器20可包括比其它部分更刚性的一些部分。例如,牵开器20可由弹性可变形材料形成,所述材料是例如天然橡胶、有机硅或者合适的可变形弹性体或弹性体材料。牵开器20还可包括由更硬的材料形成的一些部分,所述材料是例如聚乙烯、聚碳酸酯、聚酯、聚醚酰亚胺材料或不锈钢。例如,牵开器20的远侧凸缘24可以是弹性可变形的,使得在近侧凸缘22相对硬时易于插入穿过切口,从而使工作沟槽28保持预定的形状或尺寸。一旦已将牵开器20的远侧凸缘24插入到体腔中,远侧凸缘24就能够弹性地返回到其未变形构造。
本领域的技术人员将会知道,牵开器20可包括有助于将牵开器20固定在身体中的开口内并用于进入内部体腔的附加特征。在一些实施例中,牵开器20的至少一部分能够形成与患者的体壁10的表面的气密密封,使得可持续对体腔进行充气。另外,虽然在图1至图3中近侧凸缘22的面向远侧的表面和远侧凸缘24的面向近侧的表面被描绘为基本平坦,但是这些表面可以包括用于帮助将牵开器20与患者的体壁10牢固地接合的表面特征。牵开器20可另外包括配合特征,这些配合特征使得可将悬置构件40与牵开器20固定地、以可脱开的方式和/或可移动地连接。这样的配合特征可形成在牵开器20的近端、远端或中间部分或者从牵开器20的近端、远端或中间部分延伸。
悬置构件40能够将密封壳体60悬置在体腔内,通常可包括能够与牵开器20连接的近侧部分和能够延伸穿过牵开器20的工作沟槽28并与密封壳体60连接的远侧部分。悬置构件40可具有各种构造,但是在图1至图3所示实施例中,悬置构件40的近侧部分包括从悬置构件40的远侧部分径向向外延伸的环形凸缘42,所述远侧部分在所示实施例中为圆柱形套管44的形式。环形凸缘42的直径可小于、等于或大于牵开器20的近侧凸缘22,并且它的直径可大于工作沟槽28的直径,使得当将悬置构件40的圆柱形套管44插入穿过工作沟槽28的近端时,环形凸缘42与牵开器20的近端邻接或者说是接触。凸缘42可用作防止悬置构件40穿到工作沟槽28中或者穿过工作沟槽28的阻挡件。
悬置构件40的近侧部分的凸缘42被描绘为具有环形形状,但是它可具有任何形状,包括(但不限于)圆形、卵形、椭圆形、正方形和矩形形状。另外,凸缘42不必闭合或连续,但是对于非限制性实例,可包括多个沿周向间隔的、径向延伸的突出部。本领域技术人员将会知道,悬置构件40的近侧部分可具有任何构造,即,在外科手术期间,悬置构件40的近侧部分可支撑悬置构件的远侧部分。
可将悬置构件40与牵开器20一体化(比如,形成为单个一体式部件),或者可将悬置构件40与牵开器20固定地、以可拆卸的方式和/或可移动地配合。如图1至图3所示,凸缘42的面向远侧的表面能够当将悬置构件40完全插入到牵开器20中时与牵开器20的近侧凸缘22邻接。这两个相对表面能够相对于彼此滑动,使得悬置构件40可相对于牵开器20旋转,或者悬置构件40的近侧部分可通过表面特征或接合结构接合牵开器的近端以防止相对旋转,这些表面特征或接合结构形成在牵开器20或悬置构件40的近端中的任一者或两者上或者从牵开器20或悬置构件40的近端中的任一者或两者延伸。对于非限制性实例,这两个相对表面的纹理可形成为阻碍或防止悬置构件40相对于牵开器20旋转。本领域技术人员将会知道,任何数量的接合机构(比如,搭扣配合连接器、丝扣等)可用于将悬置构件40与牵开器20固定地或可拆卸地连接。本领域技术人员还将会知道,接合机构可形成在悬置构件40或牵开器20的任何部分中或者从悬置构件40或牵开器20的任何部分延伸,使得悬置构件40可连接到牵开器20的近端或远端或者近端和远端之间的任意位置。
对于非限制性实例,在图4和图5所绘的另一个实施例中,外科进入装置400的悬置构件或拴系件不像图1至图3所示的实施例中那样与牵开器420的近端邻接或连接,而是替代地包括能够被设置在牵开器420的工作沟槽内的管状壳体442。管状构件442可与挠性套管444连接,继而又可与密封壳体460连接。管状壳体442的外表面可包括用于接合牵开器420的接合机构,比如,管状壳体442的环形凸缘447可在形成在牵开器420的内表面上的相应凹槽430内搭扣配合。或者,或另外,管状壳体442的肩部450可抵靠在形成在牵开器420的内表面上的环形边缘432上,或者可与环形边缘432接合。当将外科进入装置400定位于组织中时,套管444能够延伸穿过牵开器420的工作沟槽,并可将密封壳体460悬置在体腔内。
再次参照图1至图3,悬置构件40的远侧部分可包括从凸缘42向远侧延伸的圆柱形套管44。套管44的内表面可限定通道46,外科器械可穿过通道46。套管44可具有各种构造、形状和尺寸。在所示的实施例中,套管44的形状大致为伸长的圆柱形。然而,套管44可具有各种剖面形状,例如正方形、卵圆形、矩形等。套管的尺寸也可变化。在图3所绘的示例性实施例中,套管44可具有这样的长度,即,当将套管44设置在组织内的开口中时,该长度足以延伸穿过组织,并且套管44可具有比牵开器20的高度H大的纵向长度L,使得当将密封壳体60设置在套管44内时,密封壳体60可被悬置在与牵开器20的远端相邻或者远离牵开器20的远端的位置处。套管44还可具有这样的外径,其允许将套管44设置穿过牵开器20的工作沟槽28,但是足以将密封壳体60保持在套管44中。还可以以下述方式选择套管44的外径,即,当将套管44插入到工作沟槽28中时,套管44的外表面与牵开器20的至少一部分形成气密密封。在示例性实施例中,套管44的长度可以在约4cm至约9cm范围内,套管44的外径可以在约60mm至约100mm范围内。套管44的直径不必恒定,可沿着套管28的长度而变化。
根据(例如)将进行的手术和切口的尺寸,悬置构件40可以是刚性的、半刚性的或挠性的。悬置构件40可由弹性可变性材料形成,所述材料是例如天然橡胶、有机硅或合适的可变形弹性体或弹性体材料。在一些实施例中,不止一种材料可用于形成悬置构件40,悬置构件40可包括比其它部分更刚性的一些部分。对于非限制性实例,套管44可由高挠性的弹性材料形成,使得悬置构件40的远侧部分可相对于工作沟槽28的纵轴拉伸和偏离一定角度。套管44还可由摩擦相对低、具有耐穿刺性的材料形成,所述材料容许裂开之前具有相对高的延伸率。套管44还可对由硅或其它润滑剂引起的降解有相对的抵抗力。边缘42可由与套管44相同的材料形成,或者可由不同的材料形成。由相对硬的材料(例如聚乙烯、聚碳酸酯、聚酯、聚醚酰亚胺材料或不锈钢)形成的边缘42可有助于防止悬置构件40穿过工作沟槽28。
如图1至图3所示,可将悬置构件40的远侧部分与悬置构件40的近侧部分一体化。还可使用本领域已知的任何数量的接合机构(比如,搭扣配合连接器、丝扣等)将悬置部分40的远侧部分与悬置构件40的近侧部分固定地或可移动地连接。对于非限制性实例,在图6所绘的另一个实施例中,外科进入装置600包括牵开器620、密封壳体660和具有近侧部分642和远侧部分644的悬置构件。近侧部分642包括第一管状壳体642a,其具有从其近端径向向外延伸的环形边缘642b。第一管状壳体642a可以是任何尺寸或形状,但是如图6所示,其外径可约等于或略小于牵开器620的工作沟槽628的内径,其形状可对应于牵开器620的工作沟槽的形状。第一管状壳体642a可包括形成在其内表面上的环形凸缘643。悬置构件或拴系件的远侧部分644可包括第二管状壳体644a和从第二管状壳体644a的远端向远侧延伸的挠性护套644b。挠性护套644b的远端能够与密封壳体660连接。第二管状壳体644a的外径可约等于或者略小于第一管状壳体642a的内径。第二管状壳体644a可包括形成在其外表面上的环形凹槽645。环形凸缘643能够当将第二管状壳体644a插入到第一管状壳体642a中时与环形凹槽645搭扣配合,使得悬置构件的近侧部分642与悬置构件的远侧部分644连接。
悬置构件的远侧部分还可包括用于将密封壳体保持在其中的各种接合结构。本领域技术人员将会知道,任何数量的接合机构可用于将密封壳体与悬置构件连接。在一个实施例中,如图2和图3所示,形成在圆柱形套管44的远端的内表面上的环形边缘48防止密封壳体60被向远侧按压超出悬置构件40的远端。如图3所示,环形边缘48的内径DR可小于密封壳体60的最大外径DS,使得密封壳体60可抵靠在环形边缘48上。环形边缘48不必闭合或连续,但是可以是(对于非限制性实例)多个沿周向间隔的、径向向内延伸的突出部。虽然在该示出的实施例中密封壳体60抵靠在环形边缘48上,但是可以以本领域已知的任何方式将悬置构件40与密封壳体60连接或配合,比如,形成在密封壳体的外表面中的环形凹槽可与形成在悬置构件40的远侧部分的内表面上的相应凸缘搭扣配合,或者形成在密封壳体60的外表面上的凸缘可与形成在悬置构件40的远侧部分的内表面上的相应凹槽搭扣配合。对于非限制性实例,密封壳体还可与悬置构件滑动或丝扣接合,或者可通过过盈配合连接。本领域已知的任何其它接合机构(比如,粘合剂)可用于固定地将密封壳体60保持到悬置构件40或者将密封壳体60与悬置构件40以可脱开的方式连接。此外,密封壳体60可接合悬置构件40的任何部分,使得当将进入装置100定位在组织开口内时,密封壳体60能够延伸到体腔中。
本领域技术人员还将会知道,接合机构可形成在悬置构件40或牵开器460的任何部分中,或者从悬置构件40或牵开器460的任何部分延伸,使得悬置构件40可连接到密封壳体460的近端或远端或者近端和远端之间的任何位置。对于非限制性实例,在图4至图5所绘的另一个实施例中,外科进入装置400的悬置构件包括环形环448,其能够与形成在密封壳体460中的环形肩部468配合或连接。虽然示出了悬置构件的环形环448在密封壳体460的外表面的中间部分接合悬置构件,但是本领域技术人员将会知道,悬置构件可与密封壳体460的任何部分连接,所述部分包括(例如)密封壳体460的近端。
本领域技术人员将会知道,悬置构件或拴系件可包括用于帮助将密封壳体悬置在体腔中并用于进入到内部体腔的附加特征。对于非限制性实例,悬置构件和牵开器以及悬置构件和密封壳体之间的界面能够形成气密密封,使得可持续对体腔进行充气。悬置构件还可包括防倒置特征,其用于防止当向近侧拉被设置成穿过密封元件62a、62b和62c的外科器械时套管44倒置。对于非限制性实例,套管44可包括一个或多个纵向肋,这些纵向肋防止在从密封元件取出器械期间悬置构件从里向外翻转。
本文所述的任何和全部外科进入装置还可包括多个其他结构,例如,包括一个或多个通气口,以便在采用烧灼的手术过程中排烟,和/或包括一个或多个注气口,外科医生可通过该注气口对腹部注气以形成气腹,如提交于2006年11月2日、名称为“Multi-portLaparoscopic Access Device”(多端口腹腔镜检查进入装置)的美国专利申请No.2006/0247673中非限制性实例所述,该专利据此全文以引用方式并入本文。如本领域的技术人员将了解的,注气口可位于装置上的任何位置,可以为任何尺寸,并且可以接纳勒尔锁(leurlock)或针。本领域技术人员将会知道,本文所公开的任何和全部牵开器、悬置构件、密封壳体和密封元件实施例能够持续充气,例如,可由不透气的材料形成。另外,任何部件之间的连接能够防止充气气体从体腔泄漏。
为了持续在体腔内充气,外科进入装置可包括置于其中的至少一个密封件,以防止空气和/或气体从其逸出。本领域已知各种密封元件,但是通常外科进入装置可包括:至少一个器械密封件,其用于在从穿过其中的器械周围形成密封,或换句话讲,当没有器械从其中穿过时,不形成密封;至少一个沟槽密封件或零闭合密封件,其用于当没有器械从其中穿过时密封由密封元件创建的工作沟槽,从而防止通过外科进入装置传送的充气气体泄漏到体腔;或组合器械密封件和沟槽密封件,其对在从穿过其中的器械周围形成密封和当没有器械从其中穿过时在工作沟槽中形成密封均有效。本领域技术人员将会知道,可以使用本领域已知的多种密封件,包括(例如)鸭嘴形密封件、圆锥密封件、防护件阀、凝胶密封件、隔膜密封件、唇形密封件、虹膜密封件等。本领域技术人员还应了解,任何本文所述的实施例中可包括任何密封件的组合,无论该密封件组合在具体实施例的相关说明中是否进行了详细讨论。在2004年3月31日提交的、名称为“TrocarSeal Assembly”(套针密封组件)的美国专利公布No.2004/0230161以及2003年10月15日提交的、名称为“Conical Trocar Seal”(锥形套针密封件)的美国专利公布No.10/687,502中对示例性的器械密封构造进行了更加详细的说明,以上专利申请全文以引用方式并入本文。
外科进入装置100可包括密封壳体60,其可包含可保持外科手术位置和外部环境之间的密封的一个或多个密封元件62a、62b和62c。密封壳体60通常可具有近端和远端,并能够与悬置构件40连接,使得近端和/或远端能够向远侧延伸到体腔中。本领域技术人员将会知道,所示的密封壳体60是一个实施例,密封壳体可具有各种构造、形状和尺寸。在于2009年3月6日提交的、名称为“Methods AndDevices For Providing Access Into A Body Cavity”(用于进入体腔的方法和装置)的美国专利申请No.12/399,482、于2009年3月6日提交的、名称为“Surgical Access Devices And MethodsProviding Seal Movement In Predefined Paths”(提供预定路径中的密封件移动的外科进入装置和方法)的美国专利申请No.12/399,547和于2009年3月6日提交的、名称为“Methods AndDevices For Providing Access Into A Body Cavity”(用于进入体腔的方法和装置)的美国专利申请No.12/399,625中对各种其它示例性密封壳体进行了更加详细的描述,据此以上专利申请的全文以引用方式并入。在图1至图3所绘实施例中,密封壳体60为大体圆柱形本体,其具有圆柱形外表面、具有一个或多个开口的近端和具有一个或多个开口的远端。一个或多个孔或口能够延伸穿过圆柱形本体,或者形成在圆柱形本体中,并与近端和远端的一个或多个开口对准,使得每个孔或口能够包含密封元件62a、62b和62c。孔或口可具有可将密封元件62a、62b和62c设置在其中并可使外科器械从穿过其中的任何形状、尺寸和构造。
密封元件62a、62b和62c的形状、尺寸、数量和用途可改变。如图1至图3所绘,密封壳体60包含三个密封元件62a、62b和62c。如上所述,密封元件62a、62b和62c均可包括至少一个器械密封件和/或至少一个沟槽密封件,并且通常能够与插入穿过密封元件的器械接触。尽管密封元件62a、62b和62c均可具有不同的尺寸和/或形状,但是所示实施例描绘了尺寸大致相同的两个密封元件62b和62c以及相对较大的一个密封元件62a。可将不同尺寸和形状的密封元件混合和匹配,使得得外科医生可构造用于特定患者的特定外科手术的所需装置。外科进入装置中所用的密封元件还可以是可拆卸的、可替换的和可互换的。密封元件可相对于密封壳体固定,或者可旋转或可移动。
密封元件62a、62b和62c可由各种材料制成,但是通常能够是挠性的,使得外科器械可在密封元件内移动,而不使密封件损坏。可用于形成密封元件62a、62b和62c的挠性材料实例包括聚异戊二烯、聚氨酯和有机硅。在一些实施例中,密封元件62a、62b和62c可由刚性的或半刚性的材料形成,以帮助保护从穿过其中的任何器械并将密封元件62a、62b和62c保持在密封壳体60内的大致位置上。
图7A至图7D示出可用于本发明的密封壳体插件组件2000的一个实施例。如以下更充分描述的,插件组件2000可包括外侧本体部分2100、支承构件2200、倒置约束构件2300、垫片2400、弹性器械沟槽构件2500、隔膜密封件2600和内壳体2700。
示出了外部本体部分2100的形式为大体圆柱形外壳,其具有大体圆柱形外表面2110、内表面2112、从表面2112向里径向延伸的远侧凸缘2120和内表面特征,该内表面特征例如是周向延伸的突起2114。外部本体部分2100可以是由合适的材料(例如,聚乙烯或其它合适的医用级材料)形成的大体刚性的硬外壳,使得当将插件2000插入到挠性牵开器中时,外部本体部分2100不变形到任意显著程度,而是相反可起到将挠性牵开器的工作沟槽径向或周向拉伸或者说是伸展成所需的形状和尺寸。外部本体部分2100的尺寸和形状还可使其穿过工作沟槽并一直保持在悬置构件内。例如,外部本体部分2100可具有大体圆柱形外表面2110,其外径比工作沟槽的直径小,并比形成在悬置构件或拴系件的内侧部分上的环形边缘的直径大。虽然示出了插件2000和外部本体部分2100具有大体圆形剖面形状,但是插件2000和外部本体部分2100可具有任何形状,例如(但不限于)圆形、卵圆形、矩形和三角形。圆形剖面形状可易于使插件2000相对于它保持在其中的悬置构件旋转。
插件2000的内壳体2700可包括外侧面向近侧的顶部表面2702,一个或多个器械开口2014能够延伸穿过顶部表面2702。内壳体2700还可具有大体圆柱形的外侧表面2710,其从顶部表面2702向远侧延伸。形成在外部本体部分2100的内表面中的突起2114可与内壳体2700的特征可操作地接合,所述特征例如是形成在内壳体2700的外表面2710上的周向延伸的凹槽2714。突起2114可接合凹槽2714,以相对于外部本体部分2100对内壳体2700进行轴向(即,近侧方向和远侧方向)约束,同时容许内壳体2700相对于外部本体部分2100旋转。或者,本体部分2100可包括凹槽,内壳体2700可包括用于与这样的凹槽接合的突起。
器械沟槽构件2500可被支撑在内壳体2700内。器械沟槽构件2500可包括基座2510和一个或多个器械沟槽2550,每个沟槽2550大体与基座中的近侧开口2514对准,并从基座中的近侧开口2514延伸到远侧出口2516。器械沟槽构件2500可形成为由可变形的弹性材料形成(例如,聚异戊二烯、Kraton或Sanoprene)的一体式结构,使得每个器械沟槽2550可相对于壳体2700和其它器械沟槽独立地变形。因此,插入到器械沟槽2550中的外科器械可彼此成一定角度和/或枢轴转动,从而使得每个器械相对于其它器械的运动自由度增加。每个器械沟槽2550内可设有密封件或其它压缩物,以用于在位于器械沟槽2550内的器械周围形成密封。如图7A所示,密封元件2544可设在每个器械沟槽2550的远端。如下所述,本领域已知的任何密封件可形成密封元件2544。
隔膜密封件2660可存在于内壳体2700和器械沟槽构件2500之间。隔膜密封件2600可以是大体圆柱形构件,其可包括在其整个上表面上延伸的薄隔膜。薄隔膜可由可被外科器械击穿或者说是刺穿的挠性材料形成,从而可防止在将器械插入穿过开口之前通过器械开口2014的充气损失。在一个实施例中,隔膜密封件2600可包括(对于非限制性实例)由聚氨酯形成的厚度小于约0.010英寸的隔膜,特别地,隔膜的厚度约为0.006英寸。或者,可与器械沟槽2550相连地利用零闭合密封件,零闭合密封件例如是用于在不存在器械时进行密封的鸭嘴密封件或其它合适的密封件。
外部本体部分2100的远侧凸缘2120可提供轴向推力支撑表面,在该轴向推力支撑表面上,可旋转地支撑支承构件2200。支承构件2200可以是环形构件,并可为内壳体2700和器械沟槽构件2500提供旋转支撑,使得当插件2000被悬置构件或拴系件保持时,内壳体2700和沟槽构件2500可相对于外部本体部分2100围绕牵开器的工作沟槽的纵轴旋转。支承构件2200可由任意合适的材料形成,所述材料例如是高密度聚乙烯。沟槽构件2500的旋转可使得对器械开口2014和沟槽2550进行旋转定位,以提供延伸穿过插件2000的一个或多个器械的理想定位。
可设置倒置约束构件2300以防止当从沟槽2550取出器械时器械沟槽2550变成“倒置”(比如,以从里向外拉出衬衫袖子的方式)。倒置约束构件2300可具有大体盘形的本体2320,其具有延伸穿过其中的一个或多个孔隙2340。每个孔隙2340的尺寸可形成为与相应的器械沟槽2550的远端配合。倒置约束构件2300可由任意合适的材料形成,所述材料包括(例如)聚异戊二烯、Sanoprene或Kraton。可关于插件2000的更近侧部分的挠性来定制构件2300的挠性。例如,如果使倒置约束构件2300相比于插件2000的近侧部分(例如,壳体2700的顶部表面)更挠性,则插入在器械沟槽中的器械往往会围绕与插件的更近侧部分相连的支点为枢转。或者,如果使倒置约束构件2300相比于插件2000的更近侧部分更刚性,则器械将往往会围绕与构件2300相连的支点枢转。可将倒置约束构件2300轴向定位在支承构件2200和垫片2400之间,并可从内壳体2700的远侧部分径向向里定位倒置约束构件2300。垫片2400可将沟槽2550保持在优选高度处,并可包括大体圆柱形的构件,其可在倒置约束构件和器械沟槽构件2500的基座2510之间延伸。
本领域技术人员将会知道,密封壳体可具有各种构造、形状和尺寸。在于2009年3月6日提交的、名称为“Methods and Devicesfor Providing Access into a Body Cavity”(用于进入体腔的方法和装置)的美国专利申请序号No.12/399,473、于2009年3月6日提交的、名称为“Surgical Access Devices and Methods ProvidingSeal Movement in Predefined Paths”(提供预定路径中的密封件移动的外科进入装置和方法)的美国专利申请序号No.12/399,547和于2009年3月6日提交的、名称为“Methods and Devices forProviding Access into a Body Cavity”(用于进入体腔的方法和装置)的美国申请序号No.12/399,625中对其它示例性密封壳体构造进行了更详细的描述,这些专利申请的全文据此以引用方式并入。
返回来参照图1至图3,使用时,可将外科进入装置100插入到体壁中的切口或开口中,以用于进入到内部体腔的外科手术。具体地讲,在切割出切口之后,可将牵开器20插入穿过切口并进行定位,使得远侧凸缘22延伸到患者的体腔中并与体壁的内表面接合。在一个实施例中,牵开器20的至少一部分可以具有足够挠性,使得可容易地操纵牵开器20穿过切口。当插入时,牵开器20可返回到其初始构造,使得牵开器20提供工作沟槽28,可将外科器械插入穿过工作沟槽28进入到体腔中。然后,可将悬置构件40插入到牵开器20中,比如,通过将套管44按压到工作沟槽28中,直到边缘42与牵开器20的近侧凸缘22邻接。密封壳体60的近端能够向远侧延伸超过牵开器20的远端,使得密封壳体不受工作沟槽28的径向约束。可将密封壳体60预先加载在悬置构件40中,或者,可在插入牵开器20之后将密封壳体60插入到通道46中,使得密封壳体60抵靠在边缘48上,并悬置在体腔中。然后,可将外科器械穿过通道46,并插入穿过密封壳体60的密封元件62a、62b和62c。然后,可根据外科手术的需要操纵外科器械。当将器械相对于工作沟槽28倾斜定位时,套管44可挠曲,比如,拉伸、弯曲、变形、扭曲或者说是移动,使得得可将密封壳体60相对于牵开器20倾斜定位。密封壳体60还可沿着工作沟槽的纵轴轴向移动,并可相对于工作沟槽的纵轴径向移动。换句话讲,密封壳体60将与外科器械一起移动,并不与工作沟槽28的纵向对准,以在器械周围保持密封。如果需要移除标本,或者需要其它入路,则可从密封元件62a、62b和62c移除外科器械,并可从牵开器20移除悬置构件40。然后,可通过牵开器20的工作沟槽28移除标本。本领域技术人员将会知道,可按任何顺序组装外科进入装置100。对于非限制性实例,可在将悬置构件40与牵开器20连接之前或之后将密封壳体60与悬置构件40连接。
图8至图9中示出了本发明的外科进入装置的另一个示例性实施例。与图1至图3的外科进入装置100相同,外科进入装置800可包括用于提供穿过组织的工作沟槽的牵开器、具有近侧部分842和远侧部分844的悬置构件或拴系件以及其中设置有至少一个密封元件862a、862b和862c的密封壳体860。
图8至图9所示的实施例的牵开器可具有近端和远端以及延伸穿过其中的工作沟槽。近端和远端可具有可将牵开器固定在切口内的任意合适的构造。如图8至图9所示,牵开器的近端可包括牵开器壳体822,其可被设置在患者的身体外部,并且当在外科手术期间进行定位时可与患者的体壁810的外表面接合。牵开器壳体822可形成牵开器的近端,或者可以是使用本领域已知的任何方法将其与牵开器的近端固定或可拆卸地连接的单独的部件。牵开器壳体822可以大体是环形,并可具有任何形状,例如具有(对于非限制性实例)圆形、卵形、椭圆形、正方形或矩形形状的闭合或基本闭合的构造。牵开器壳体822可另外包括用于与悬置构件的近端连接的接合结构。本领域技术人员将会知道,任何已知的接合机构可用于将悬置构件与牵开器壳体822连接。
图8至图9的牵开器的远端还可具有可将牵开器固定在切口内的任意合适的构造。例如,如以上参照图1至图3所讨论的,牵开器的远端可形成为环形凸缘。或者,牵开器可包括挠性裙边824,其可帮助将工作沟槽保持在打开构造中。当牵开器置于切口中时牵开器向远侧延伸穿过体壁810时,裙边824可向外径向呈喇叭形展开。裙边824的外表面可包括表面特征,其有助于将牵开器824与患者的体壁810牢固地接合。
图8至图9所示实施例的牵开器可以是刚性的、半刚性的或者挠性的,并可由任何合适的材料形成。在一些实施例中,不止一种材料可用于形成牵开器壳体822和裙边824,并且牵开器可包括比其它部分更刚性的一些部分。对于非限制性实例,裙边824可由弹性可变形材料形成,所述材料例如是天然橡胶、有机硅或合适的可变形弹性体或弹性体材料,而牵开器壳体822可由更硬的材料形成,所述材料例如是聚乙烯、聚碳酸酯、聚酯、聚醚酰亚胺材料或不锈钢。例如,可使裙边824变形以容易地插入穿过体壁810中的切口。一旦裙边824被完全插入穿过切口,裙边824就可脱开,并可弹性地返回到其未变形构造,使得工作沟槽828保持打开。
图8至图9所绘实施例的悬置构件或拴系件可具有各种构造,但是在一个示例性实施例中,悬置构件的近侧部分可包括卡圈842,其能够与牵开器壳体822连接。卡圈842可限定可使器械从其穿过进入到工作沟槽828中的通道。卡圈842可具有任何形状,但是通常具有与和其连接的牵开器壳体822相同的形状。本领域技术人员将会知道,任何数量的接合机构可用于将卡圈842与牵开器壳体822固定或可拆卸地连接。如图9所绘实施例所示,当将卡圈842插入到牵开器壳体822中时,环形凸缘843可从卡圈842用于搭扣配合的外表面延伸到形成在牵开器壳体822的内表面上的相应环形凹槽830中。卡圈842还可与牵开器壳体822滑动或丝扣接合,或者可以以任何其它方式(比如,通过过盈配合)连接。还可将卡圈842与牵开器壳体822连接,使得卡圈842可以相对于牵开器壳体822旋转。卡圈842可以是刚性的、半刚性的或者挠性的,并可由任何合适的材料形成。在一些实施例中,不止一种材料可用于形成卡圈842,并且卡圈842可包括比其它部分刚性的一些部分。
本领域技术人员将会知道,任何数量的连接机构可用于将套管844与卡圈842固定或可拆卸地连接。例如,可通过搭扣配合或过盈配合或者用粘合剂将套管844与卡圈842连接。还可将套管844与卡圈842一体化。套管844可由任何高挠性的弹性可变形材料形成,所述材料例如是天然橡胶、有机硅或合适的可变形弹性体或弹性体材料,使得套管844可相对于工作沟槽的纵轴拉伸和偏离一定角度。套管844还可由摩擦相对低、具有耐穿刺性的材料形成,所述材料容许裂开之前具有相对高的延伸率。套管844还可由对硅或其它润滑剂引起的退化相对有抵抗力的材料形成。套管844可具有任何长度,但是,优选地,其完全伸展的长度大于或等于牵开器的高度,使得当牵开器被定位在组织中时,与套管844的远端连接的密封壳体860能够向远侧延伸超过牵开器的远端进入到体腔中。此外,套管844能够向远侧延伸超过牵开器的远端足够的距离,以将密封壳体860的近端设置在超过牵开器的远端的远侧。套管844可另外包括防倒置特征,其用于防止套管844倒置或者向近侧拉出穿过工作沟槽的近端。
可将套管844与密封壳体860连接,并且套管844可将密封壳体860悬置在工作沟槽内的第一位置处。本领域技术人员将会知道,任何数量的连接机构可用于将套管844与密封壳体860固定或可拆卸地连接。或者,可将套管844与密封壳体860一体化,以将密封壳体860和套管844形成为单个部件。在一个示例性实施例中,如图9所示,套管844的远端可包括弹性体模制套管848。模制套管848能够围绕密封壳体860的外表面的至少一部分。模制套管848的静止直径可小于密封壳体860的直径,使得模制套管848可围绕密封壳体860拉伸。弹性的弹性体模制套管848可压向密封壳体860的外表面以形成气密密封。本领域已知的任何其它接合机构也可用于固定地将密封壳体860保持到套管844或者将密封壳体860与套管844以可脱开的方式连接。此外,悬置构件的任何部分可与密封壳体860的任何部分接合,使得密封壳体860能够延伸到体腔中。
本领域技术人员将会知道,密封壳体860可具有各种构造、形状和尺寸。如图8至图9所绘,密封壳体860可包含三个密封元件862a、862b和862c。尽管密封元件862a、862b和862c的尺寸和/或形状均可与其它密封元件不同,但是所示实施例描绘了形成在密封壳体860中的三个平行的狭缝密封件。密封壳体860可以由弹性可压缩材料形成,使得狭缝密封元件862a、862b和862c可以适形于插入穿过其中的外科器械,以保持体腔和外部环境之间的密封。当移除器械时,密封壳体860的弹性材料可再次自密封。
使用时,可与以上参照图1至图3的外科进入装置100所讨论方式类似地,将图8至图9的外科进入装置800插入在切口中。可将密封壳体860与套管844的远端连接,并且可将密封壳体860悬置在牵开器的工作沟槽828内的第一位置处。然后,可将外科器械穿过置于密封壳体860中的密封元件862a、862b和862c,并可操纵外科器械,使得套管844向远侧延伸穿过工作沟槽828。套管844可以挠曲,比如,拉伸、弯曲、变形、扭曲或者说是移动,使得得密封壳体860向远侧延伸超过牵开器的远端和/或相对于牵开器成一定角度地定向。对于非限制性实例,套管844可以与图4和图5所绘的外科进入装置400的套管444的移动类似地挠曲。
图10中示出了外科进入装置1000的另一个示例性实施例。外科进入装置1000与图4中的外科进入装置400类似,并可包括密封壳体1060,该密封壳体1060具有一个或多个可互换的密封元件1062a、1062b和1062c。外科进入装置1000可包括悬置构件或拴系件,其可从牵开器1020悬置密封壳体1060。管状壳体1042能够被设置在牵开器1020的工作沟槽内。管状壳体1042的外表面可包括用于接合牵开器1020的接合机构。管状壳体1042可与挠性套管1044连接,继而又与密封壳体1060连接。密封元件1062a、1062b和1062c中的每个均可包括可使密封元件1062a、1062b和1062c彼此连接以在体腔内的外科手术位置和外部环境之间形成密封的配合元件。例如,密封元件1062a、1062b和1062c中的每个均可分别包括单个横档1064a、1064b和1064c和单个引导件(guide)1066a、1066b和1066c,它们可与其它密封元件1062a、1062b和1062c的相邻横档和引导件以及用于与套管1044连接的接合机构1048互补。密封元件1062a、1062b和1062c可由挠性材料形成,使得当将器械插入穿过其中时,密封元件1062a、1062b和1062c可贴合在外科器械周围。密封元件1062a、1062b和1062c可与横档1064a、1064b和1064c以及引导件1066a、1066b和1066c一体化,或者可与横档1064a、1064b和1064c以及引导件1066a、1066b和1066c连接。横档1064a、1064b和1064c以及引导件1066a、1066b和1066c可由与密封元件1062a、1062b和1062c相同的材料形成,或者可由更硬的材料形成,所述更硬的材料例如是聚乙烯或不锈钢。因此,外科进入装置1000可以使得外科医生可调整密封壳体1060并将密封元件1062a、1062b和1062c互换。在Shelton等人于[]提交的名称为“Interlocking Seal Components”(互锁密封部件)的美国专利申请No.[][代理人案卷号100873-352(END6563USNP)]中对可与所公开的系统、装置和方法结合使用的可交换的密封元件进行了进一步的论述,该专利申请的全文据此以引用方式并入。
本领域技术人员根据上述各实施例,会认识到本发明的更多特征和优点。因此,本发明不受已具体示出和描述的内容所限制,而是由所附权利要求书限定。本文引述的所有出版物和参考文献都明确地以引用方式全文并入本文中。
此外,可根据需要,将本文所公开的任何和全部牵开器、悬置构件或拴系件、密封壳体的各种实施例和密封元件实施例彼此互换。例如,套件可包括多个牵开器、悬置构件或拴系件和具有各种密封元件的密封壳体。外科医生可选择每个部件的合适的尺寸、形状和构造。
当将外科器械插入穿过本文所述的外科进入装置实施例时,会存在的风险是,特别尖锐的器械可撕裂或刺穿牵开器、悬置构件或拴系件、密封壳体、密封元件或附近组织的一部分。因此,在本文所述的任何和全部实施例中,可任选地可包括安全护罩,以降低被外科器械撕裂或刺穿的风险。通常,防护罩可以为相对光滑的材料,以方便器械通过,但又能抗撕裂或刺穿。例如,防护罩可以用硅胶、氨基甲酸酯、热塑性弹性体、橡胶、聚烯烃、聚酯、尼龙、氟聚合物以及本领域已知的任何其他合适材料形成。防护罩通常可提供用于牵开器或组织的内衬,并可从外科进入装置拆卸,所以可根据特定手术的需要加以使用。防护罩还可与本文所述的任何外科进入装置实施例或任何部件一体化。这些部件本身也可用作防护罩。
在本文所公开的任何和全部外科进入装置实施例中,可包括接合和/或脱开机构,使得得一个部件可与另一个部件分离,或者使得部件的一部分与部件的另一部分分离。例如,密封元件可与密封壳体分离。接合或脱开机构可以是闩锁、开关、c形夹具、突出部、按钮或本领域已知的能够使装置的一部分与另一部分脱开的任何其它机构。
本文所公开的任何和全部外科进入装置实施例可任选地包含多种特征。例如,装置的部件(例如,牵开器、悬置构件或拴系件或者密封壳体)可具有形成在其上或者其周边周围的一个或多个光源,使得得当将所述装置插入在患者内时可视性能够更好。如将会理解的,任何波长的光均可用于各种应用,无论是可见光还是不可见光。可将任何数量的工作沟槽、悬置构件或拴系件、密封壳体和密封元件包括在牵开器上和/或穿过牵开器,使得得能够根据特定手术的需要使用各种外科技术和装置。例如,通过开口和端口可以引入压缩气体、真空系统、能源(如射频和超声)、冲洗、成像等。本领域的技术人员将会知道,可将任何这些技术和装置可拆卸地连接到外科进入装置上,并可以根据需要进行更换和操作。
本文所公开的装置可设计成一次性使用,也可以设计成多次使用。然而无论是哪种情况,该装置都可在至少使用一次后经过修复再行使用。修理可包括拆卸装置、清洗或更换具体部件以及后续重新组装的其中任意几个步骤组合。具体地讲,可拆开该装置,并且可按照7任何组合选择性地更换或拆下装置的任何数量的特定零件或部件。清洗和/或更换特定部件后,可在修理厂或在紧临外科手术前由手术小组人员将器械重新装配,以供后续使用。本领域的技术人员将会知道,修复器械时可利用多种技术进行拆卸、清洗/更换和重新组装。这些技术的使用以及所得的修复器械均在本发明的范围内。
优选的是,本文所述的发明将在外科手术前进行处理。首先,如果需要的话,获得新的或使用过的外科器械和进入装置,并对它们进行清洁。然后,可对外科手术设备进行消毒。本领域技术人员已知的任何数量的消毒技术可用于对设备进行消毒,包括通过β或γ辐射、环氧乙烷、蒸汽以及液浴(如冷浸)。在一种消毒技术中,将设备置于闭合并密封的容器中,例如在塑料或TYVEK口袋中。然后将容器和设备置于可穿透该容器的辐射场,例如γ辐射、X射线或高能量电子。辐射将杀死设备上和容器中的细菌。然后可将消毒后的设备保存在消毒容器中。密封后的容器使设备保持在无菌状态,直到在医疗设备中打开该容器为止。
Claims (22)
1.一种外科进入装置,包括:
挠性牵开器,所述挠性牵开器具有延伸穿过其中的工作沟槽;和
密封壳体,所述密封壳体具有置于其中的多个密封元件,所述多个密封元件能够在插入穿过其中的器械周围形成密封,通过与所述挠性牵开器连接的挠性拴系件使所述密封壳体能够自由移动地悬置在所述挠性牵开器的远侧部分内,使得所述密封壳体的至少一部分能够向远侧延伸超过所述挠性牵开器的远端,并能够自由地相对于所述挠性牵开器成一定角度地定向。
2.根据权利要求1所述的装置,其中所述挠性拴系件包括近侧壳体,所述近侧壳体与所述挠性牵开器上的牵开器壳体可旋转地连接。
3.根据权利要求1所述的装置,其中所述挠性拴系件包括圆柱形远侧部分和抵靠所述挠性牵开器的近端的近侧凸缘。
4.根据权利要求1所述的装置,其中所述密封壳体能够在所述挠性牵开器的整个工作沟槽上形成密封。
5.根据权利要求1所述的装置,其中所述挠性拴系件的远侧部分包括能够与所述密封壳体可拆卸地接合的接合结构。
6.一种外科进入装置,包括:
牵开器,所述牵开器具有近端和远端以及延伸穿过其中的工作沟槽,所述近端能够与组织的外表面相邻,所述远端能够延伸进入到体腔中,使得所述工作沟槽提供穿过所述组织的通路;
悬置构件,所述悬置构件具有近侧部分和远侧部分,所述近侧部分能够与所述牵开器的近端连接,所述远侧部分延伸穿过所述牵开器的所述工作沟槽;和
密封壳体,所述密封壳体被设置在所述悬置构件的远侧部分内,并具有置于其中的至少一个密封元件,所述至少一个密封元件能够在穿过其中的器械周围形成密封;
其中所述悬置构件的至少一部分是挠性的,使得得所述密封壳体能够延伸超过所述牵开器的远端。
7.根据权利要求6所述的装置,其中所述悬置构件的远侧部分由弹性材料形成。
8.根据权利要求6所述的装置,其中所述悬置构件的远侧部分包括能够与所述密封壳体可拆卸地接合的接合结构。
9.根据权利要求8所述的装置,其中所述接合结构包括环形构件,所述环形构件的内径小于所述密封壳体的最大外径,使得所述环形构件能够将所述密封壳体保持在所述悬置构件的远侧部分内。
10.根据权利要求6所述的装置,其中所述牵开器包括中空挠性圆柱形构件,所述中空挠性圆柱形构件的中间部分的最大直径小于所述牵开器的近端和远端的最大直径,使得所述中间部分能够被定位在组织内的开口中,并且所述近端和远端能够接合所述近端和远端之间的组织。
11.根据权利要求6所述的装置,其中所述悬置构件的远侧部分包括挠性套管。
12.根据权利要求6所述的装置,其中所述悬置构件的远侧部分大体上为圆柱形,所述悬置构件的近侧部分包括径向向外延伸的凸缘,所述凸缘能够抵靠所述牵开器的近端。
13.根据权利要求12所述的装置,其中所述悬置构件的远端包括形成在其内表面上的环形边缘,并能够将所述密封壳体保持在所述悬置构件的远侧部分内。
14.根据权利要求6所述的装置,其中所述悬置构件的近侧部分包括与所述牵开器的近端的壳体配合的卡圈,并且所述悬置构件的远侧部分包括挠性套管。
15.根据权利要求14所述的装置,其中所述挠性套管的远端与能够接合所述密封壳体的环形构件连接。
16.根据权利要求14所述的装置,其中所述卡圈与所述牵开器上的壳体可旋转地配合。
17.根据权利要求6所述的装置,其中所述至少一个密封元件包括多个密封元件。
18.根据权利要求6所述的装置,其中所述密封壳体能够在所述牵开器的整个工作沟槽上形成密封。
19.一种用于进入体腔的方法,包括:
将挠性牵开器定位在组织内,使得所述挠性牵开器的工作沟槽形成穿过所述组织并进入到体腔中的通路;以及
将外科器械插入穿过密封壳体中的密封元件,以将所述外科器械的远端定位在体腔中,所述密封壳体通过在所述密封壳体和所述挠性牵开器的近侧部分之间延伸的挠性拴系件而悬置在所述体腔内。
20.根据权利要求19所述的方法,还包括:操纵所述外科器械以使所述密封壳体相对于所述挠性牵开器移动,从而使所述挠性拴系件挠曲。
21.根据权利要求19所述的方法,还包括:从所述牵开器移除所述挠性拴系件和所述密封壳体,并将所述牵开器留置在所述组织中。
22.根据权利要求19所述的方法,还包括:将第二外科器械插入穿过所述密封壳体中的第二密封元件,以将所述第二外科器械的远端定位在所述体腔中。
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Also Published As
Publication number | Publication date |
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CA2698059A1 (en) | 2010-09-30 |
EP2238926A2 (en) | 2010-10-13 |
US8357085B2 (en) | 2013-01-22 |
CA2698059C (en) | 2017-09-12 |
AU2010200982A1 (en) | 2010-10-14 |
KR101734065B1 (ko) | 2017-05-11 |
AU2010201024B2 (en) | 2015-05-14 |
JP2010240405A (ja) | 2010-10-28 |
AU2010200982A8 (en) | 2016-01-28 |
CN101849848A (zh) | 2010-10-06 |
EP2238926A3 (en) | 2015-04-22 |
KR20100109480A (ko) | 2010-10-08 |
JP5717974B2 (ja) | 2015-05-13 |
CN101849847B (zh) | 2014-05-14 |
JP2010240404A (ja) | 2010-10-28 |
US20100249525A1 (en) | 2010-09-30 |
KR20170001946A (ko) | 2017-01-05 |
AU2010200982B2 (en) | 2016-01-21 |
AU2010201024A1 (en) | 2010-10-14 |
JP5638270B2 (ja) | 2014-12-10 |
CN101849848B (zh) | 2014-03-26 |
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