CN101849848A - 进入装置 - Google Patents
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- A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
- A61B17/3421—Cannulas
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- 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
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Abstract
本发明提供了通过单个外科手术进入装置插入多个外科手术器械的各种装置和方法。公开了包括挠性组织牵开器和具有多个器械开口的可脱开插件的医疗装置。所述插件可具有包括多个部件的插件组件的形式。还描述了使用该插件的方法。
Description
本专利申请以引用的方式并入于2009年6月5日提交的US序列号12/479,418、“Device and Methods for Providing Access Intoa Body Cavity”的部分继续申请,并要求该部分继续申请的优先权;本专利申请还以引用的方式并入于2009年3月31日提交的序列号为61/165,080的临时专利申请,并要求该临时专利申请的优先权。
交叉引用
本申请交叉引用了以下共同转让的美国专利申请,并以引用的方式并入这些专利申请:于2006年4月5日提交的US序列号11/398,985,其公布为US20060247673;于2006年4月5日提交的US序列号11/399181;于2006年4月5日提交的US序列号11/399145;于2006年4月5日提交的US序列号11/399149;于2006年4月5日提交的US序列号11/399044;于2006年4月5日提交的US序列号11/399172;于2006年4月5日提交的US序列号11/399045;于2008年9月30日提交的US序列号12/242,765;于2008年9月30日提交的US序列号12/242,711;于2008年9月30日提交的US序列号12/242,721;于2008年9月30日提交的US序列号12/242,383;于2008年9月30日提交的US序列号12/242,333;于2008年9月30日提交的US序列号12/242,353;于2008年9月30日提交的US序列号12/242,381;于2009年3月6日提交的US序列号12/399,625;于2009年3月6日提交的US序列号12/399,633;于2009年3月6日提交的US序列号12/399,547;于2009年3月6日提交的US序列号12/399,656;于2009年3月6日提交的US序列号12/399,482;US序列号12/399,473;于2008年4月28日提交的US序列号12/110,724;于2008年4月25日提交的US序列号12/109,881;于2008年4月29日提交的US序列号12/425;和于2008年7月14日提交的US序列号12/172,349。
技术领域
本发明涉及进入装置,例如外科手术中用于进入体腔的进入装置。
发明背景
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腔壁的较小切口开展手术。
腹腔镜手术通常涉及将CO2气体充入腹腔,使压力达到约15mmHg。在腹壁上打孔,然后将直径为5-10mm的直管状插管或套针套管插入腹腔。与手术室监视器相连的腹腔镜用于显现手术视野,并且穿过套针套管。将腹腔镜手术器械(抓紧器、解剖器、手术剪、牵开器等)穿过两个或更多个另外的套针套管,以供外科医生和手术助手操作。
最近已经推出了采用直径为2-3mm的直套针套管和腹腔镜用器械的所谓的“迷你腹腔镜手术”。成功的迷你腹腔镜手术可进一步减小腹壁创伤并改善外观效果然而,迷你腹腔镜手术所用的器械通常更加昂贵而易碎。由于其较小直径所导致的性能局限性(冲洗系统弱、耐用性差、视频质量下降),迷你腹腔镜手术器械通常只能用于解剖状态较佳(腔壁薄、几乎无粘连、极少发炎等)的部分患者。这些患者只占需要进行腹腔镜手术的患者的一小部分。此外,2-3mm的较小切口可能仍会产生不可取的外观效果和伤口并发症(出血、感染、疼痛、形成瘢痕疙瘩等)。
事实证明更小、更少的体腔切口是有益的,因此人们期望只通过肚脐内的单个切口来开展手术。肚脐具有很好的隐蔽性,并且是腹壁最薄和血管化最少的部位。它通常是腹腔镜手术中腹腔入口的优选部位。肚脐切口可容易地扩大(以取出较大的样本),并且不会明显影响术后美观,也不会增加伤口并发症的几率。将两根或更多根标准(直)套管以及腹腔镜用器械彼此相邻放入肚脐,会形成所谓的“筷子效应”,该效应描述了外科医生双手之间、外科医生双手和器械之间以及器械之间的干扰作用。这种干扰作用大大降低了外科医生进行所述手术的能力。
因此,需要有这样一种器械和套针系统,其可以使得完全穿过肚脐或位于其他部位的手术口进行腹腔镜手术,同时可减轻或消除“筷子效应”。
发明内容
本发明总体上提供了外科手术中用于进入患者体内的装置。
在一个实施例中,所述医疗装置包括组织牵开器和以可脱开的方式被支撑在与组织牵开器相连的通道内的插件。插件可具有外表面,该外表面的尺寸和形状形成为使组织牵开器的挠性构件变形以将通道的至少一部分设置成预定的尺寸和形状。
插件可以是具有大体圆柱形的外表面的插件组件的形式,该外表面的尺寸形成为当将插件插入到通道内时径向拉伸组织牵开器的一部分以得到具有预定直径或宽度的大体圆形或其它合适的剖面。
组织牵开器可以是包括例如挠性隔膜的挠性构件的挠性组织牵开器,该挠性组织牵开器具有第一末端和第二末端,插件可以以可脱开的方式被支撑在或者说是以可脱离的方式被插入到挠性组织牵开器的通道内。
在一个实施例中,插件包括具有内侧部分和外侧部分的组件。外侧部分的大体圆柱形外表面适于与组织牵开器的通道的内表面接合,内侧部分可包括多个器械开口,这些器械开口与能够相对于插件的外侧部分和挠性组织牵开器旋转的器械通道对准。
插件可包括这样的组件,该组件包括:外部本体部分,其尺寸和形状形成为与挠性组织牵开器的内表面接合并使挠性组织牵开器的内表面变形;壳体,该壳体至少部分置于外部套管内,在壳体的上表面中至少有一个器械开口;和至少一个密封件,所述至少一个密封件与每个器械开口可操作地相连。插件组件还可包括器械沟槽构件,其具有限定多个管状器械沟槽的一体式挠性结构的形式。可使每个管状器械沟槽相对于壳体和其它管状器械沟槽独立地变形。可相对于外部套管和组织牵开器旋转地支撑器械沟槽和器械开口,例如通过支承构件来旋转地支撑器械沟槽和器械开口。
在一个实施例中,挠性组织牵开器包括第一可变形环和第二可变形环,插件的尺寸和形状形成为穿过这两个环中的至少一个,而不使该环变形。插件的尺寸和形状形成为使在第一环和第二环之间延伸的挠性构件的一部分变形。
在一个实施例中,提供一种包括挠性组织牵开器、插件和套管的组件。可将套管定位在挠性组织牵开器中,并且可将插件按压到套管中。可将套管和插件一起从牵开器中移除,而不从切口移除牵开器。可设置套管来帮助插入和移除插件,套管可由摩擦系数相对低、抗穿刺性相对高和/或韧性高的材料形成。
在一个实施例中,提供了一种通过切口进入体腔的方法。该方法包括以下步骤:将组织牵开器定位在切口中;和以可脱开的方式将具有多个器械开口的插件定位到组织牵开器中。定位插件的步骤可通过将插件按压到组织牵开器中来实现,并可包括使组织牵开器的至少一部分变形和/或拉伸的步骤。该方法可包括以下步骤:形成切口;将组织牵开器定位在切口中;定位套管以使其至少部分延伸在组织牵开器内;和将具有一个或多个器械开口的插件定位到套管中。
在一个实施例中,提供一种包括组织牵开器和具有至少一个器械开口的至少一个插件的医疗装置,其中,例如可通过将插件按压在组织牵开器的通道内的不同插入深度处来定位插件。
在一个实施例中,进入体腔的方法包括以下步骤:将挠性组织牵开器定位在切口中,其中组织牵开器提供延伸穿过切口的通道;将具有至少一个器械开口的第一插件以可脱开的方式定位在由挠性组织牵开器提供的通道中;从由组织牵开器提供的通道移除第一插件;和将具有至少一个器械开口的第二插件定位在通道中。第二插件可具有与第一插件不同数量的器械开口和/或不同的尺寸和/或不同的形状。该方法还可包括将插件重新定位到牵开器的通道中的第二深度处的步骤。
附图说明
由下文的“具体实施方式”并结合附图,可更完整地理解本发明。现将各附图说明如下:
图1是示出包括插件的进入装置的近侧透视图,该插件具有以可脱开的方式被支撑在挠性组织牵开器内的至少一个器械开口,所示插件的近端被插入到挠性组织牵开器的上侧近端的下方;
图2是图1所示的插件和挠性组织牵开器的远侧透视图,示出了可从挠性组织牵开器的下侧的远侧开口看见插件的远侧底端;
图3是图1所示类型的装置的截面图;
图4是图1所示类型的插件的分解图;
图5是示出包括插件、挠性组织牵开器和套管的组件的可替代进入装置的近侧透视图,示出了套管包括置于挠性组织牵开器的近端上方的大体环形部分,示出了套管包括从环形部分向远侧延伸的大体圆柱形部分,套管的大体圆柱形部分的至少一部分被设置在插件和挠性组织牵开器之间;
图6是图5所示类型的装置的剖面图,示出了大体圆柱形部分向远侧延伸超出组织牵开器和插件的远端,示出了圆柱形部分的远端具有大体周向延伸的肋或凸缘形式的构件,其用于防止将插件按压到体腔中并有助于从组织牵开器取出插件;
图7是与图4所示插件类似的插件的示意性分解图,但是该插件具有三个器械开口(与四个器械开口不同),这三个器械开口包括一个相对大的器械开口(例如用于容纳腹腔镜或其它直径相对大的装置)和两个相对小的器械开口(例如用于容纳相对小的装置,诸如5mm抓紧器、施夹钳等);
图8是可如何将图7中的插件插入到套管(显示一半截面)中,继而可将插件和套管插入到挠性组织牵开器(也显示一半截面)中的示意性描绘;
图9示出设置在组织中的插件、套管和组织牵开器,示出了将插件插入到套管中并由套管支撑插件,继而在组织牵开器中支撑插件,示出了套管和牵开器一半截面,并且图9示出套管的长度比牵开器的轴向长度长,以使得可以将套管定位于牵开器内的各种深度处,并使得在图9中,示出的插件的远侧部分定位于腹壁下方,并且插件的远侧部分与套管的远端处的内边缘形式的保持特征(retention feature)邻接,保持特征防止插件被推压穿过套管进入到腹腔中,当从挠性牵开器取出套管时,边缘有助于将插件与套管一起移除;
图10是透视图,其示出可如何通过用单手的手指抓紧套管的边沿并向近侧提起套管(图10中的向上方向)来移除套管和插件,此时,套管保持插件并且当从牵开器取出套管时将插件与套管一起移除,并将牵开器留在切口中适当的位置处;
图11是示出如何实现一旦从挠性牵开器移除套管和插件,就可通过挠性牵开器从身体移除标本和/或标本袋的透视图;
图12是示出将插件设置在挠性牵开器内的实施例的示意性剖视图,其中,挠性牵开器具有内肋形式的内部保持特征,其用于使插件保持在牵开器内所需的深度处,并且图12示出牵开器内的插件挠性支撑如何使得延伸穿过插件的器械使插件本身枢转,以得到安装在牵开器上方或下方的密封件上方的器械的改进运动范围;
图13提供插件、套管和牵开器的示意性剖视图,其中,插件包括插件近端处的鸭嘴密封件形式的零闭合密封件和隔膜密封件形式的器械密封件,零闭合密封件用于当没有器械插入穿过器械进入沟槽时密封沟槽,器械密封件用于密封插入到器械沟槽中的器械。
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器械和方法的结构、功能、制造和使用原理的全面理解。这些实施例中的一个或多个实例在附图中示出。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以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。
本发明总体上提供一种例如外科手术进入组件的医疗装置,其可通过单一切口外科手术进入装置插入一个或多个外科手术器械,例如插入到各种插入深度处,从而使得能够在持续充气的同时容易地在患者体内操纵器械。
图1是进入组件的顶部或近侧部分的透视图,图2是进入组件的底部或远侧部分的透视图。参照图1和图2,在一个实施例中,医疗装置的形式为如下的进入组件,其包括挠性组织牵开器1000和具有至少一个器械开口2014(图1所示为4个器械开口2014,图2所示为4个器械出口2016)的插件2000。器械开口2014可延伸穿过插件的一部分的顶部表面2702,并且如以下将更详细描述的,可通过隔膜密封件2600使开口2014闭合,或换句话讲,使开口2014阻塞。
示出了插件2000以可脱开的方式被支撑在由牵开器1000的挠性构件1100限定的通道1104内。短语“以可脱开的方式被支撑”在本上下文中的意思是指可以插入插件并从组织牵开器移除插件多次(包括在外科手术操作期间)而不毁坏或者说是破坏牵开器或插件的功能。在一个示例性的实例中,通过将插件按压(例如用拇指或手指按压)到牵开器的通道中来以可脱开的方式插入插件2000。
挠性构件1100可包括第一大体成形为环形的外侧或顶部部分1120(图1中的大体水平取向)、第二大体成形为环形的内侧部分1160(图1中的大体水平取向并且大体与部分1120平行)和大体成形为圆柱形的部分1140,该部分1140沿从部分1120到部分1160的远侧方向轴向延伸。
可将外侧部分1120与挠性构件1100的第一近端1101相连,可将内侧部分1160与挠性构件1100的第二远端1103相连。当在外科手术期间定位挠性牵开器时,将外侧部分1120设置在患者身体的外部,在外科手术操作期间将内侧部分1160设置在患者内,例如体腔内。大体圆柱形部分1140的内表面可提供通道1104的大部分或者基本上全部,同时例如如图3所示,当在外科手术期间定位挠性牵开器1000时,大体圆柱形部分1140的外表面可与切口壁接触。
挠性构件1100可包括形成部分1120、1140和1160的一体式挠性隔膜,该隔膜具有第一表面1102和第二表面1106。组织牵开器1000的通道1104可至少部分由大体圆柱形部分1140中的径向朝内的第一表面1102的一部分限定。第二表面1106与大体圆柱形部分1140相连的部分可径向朝外以在切口位置与组织接触或者说是接合。
挠性组织牵开器1000还可包括近侧构件和远侧构件,这些构件使牵开器的外侧部分和内侧部分与患者的外侧部分和内侧部分接合。例如,组织牵开器1000可包括弹性外侧(近侧)可变形环1200和弹性内侧(远侧)可变形环1400。在图1和图2中以虚线显示环1200和1400,在图3中显示了环1200和1400的剖面。示出了挠性构件1100在环1200和1400之间延伸,以使构件1100从环1200延伸到环1400。
图3示出以下述方式将挠性牵开器1000和插件2000的进入组件定位在切口中,即,将牵开器1000的远侧部分1160和环1400设置在腹腔40中,并且组织60(包括腹壁的一部分)与挠性牵开器的表面1106接合。
环1200和1400可具有任何合适的闭合或者基本闭合的构造,包括(但不限于)圆形、卵形和椭圆形构造。“弹性可变形环”是指可例如通过用手指(不用任何另外的工具或帮助)同时按压环的相对侧相对容易地使环变形,以使可将环插入穿过体壁(比如,腹壁)中的窄切口。例如,例如通过用手指同时按压内环1400的相对侧来使内环1400变形,可使内环1400变形,并使内环1400插入穿过患者的切口,例如穿过腹壁的切口。一旦环被完全插入,内环1400就能够弹性地返回到其未变形的形状。环通过与腹腔的腹壁的内表面接合来帮助将牵开器1000固定在切口内。
挠性构件可包括弹性可变形材料的挠性隔膜,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。可将可变形环附接到挠性隔膜,或者将其封闭在隔膜的卷起端内。一种合适的包括具有可变形内环和可变形外环的挠性构件的挠性组织牵开器为可得自Hakko的作为Hakko FF0707的组织牵开器。
可将挠性组织牵开器设成一种或多种尺寸,在一个实例中,挠性组织牵开器的长度或高度(沿图3中的轴70的方向测量)为约15mm至约30mm,最大直径与环1200/1400的直径相应并为约40mm至约80mm,内侧通道直径为约20mm至约40mm。在附图中,示出了环的直径大体相同,但是应当理解,可选择环1200的直径大于环1400的直径,或者环1200的直径可以小于环1400的直径。在一个实施例中,内侧通道直径小于容许用户的手从其通过所需的直径并且大体小于约50mm的挠性组织牵开器可以是理想的,从而允许多个器械进入而不要求相对大的切口。
挠性组织牵开器1000可形成为具有自支撑的预定形状,例如图1中所示形状。“自支撑”是指当将牵开器1000放置在基本水平的表面(比如,平坦的桌子顶部)时,牵开器能够保持其形状而不伸缩,此时,通道1104基本垂直延伸,部分1160使部分1120和1140彼此分离预定距离。
在图1至图3中,示出了将插件2000按压到或者说是定位在通道1104内,以将插件2000和器械开口2014设置在挠性组织牵开器的环1200和环形部分1120下方。如图3所示,构件(例如,内肋1108形式的保持特征)可形成有牵开器的内表面,或者说是设在牵开器的内表面上。可定位肋1108,以防止将插件2000推压穿过牵开器1000进入到体腔40中。
在图2和图3中,示出了插件2000的远端和器械出口2016大致延伸到挠性牵开器的远侧环1400和远侧部分1160处,或者大致延伸到挠性牵开器的远侧环1400和远侧部分1160下方。因此,将插件2000定位在牵开器1000内从而得到薄型,以使插入到开口2014中且伸出出口2016的器械能够相对于插件2000和/或彼此在定位于上侧的近侧环1200远侧的枢轴点(例如,定位于切口内的枢轴点)枢轴转动。这样的薄型构造使得插件2000中与器械通道相连的密封件驻留在环1200下方,具体地讲,在切口内或者在腹腔内。不受理论限制,据信腹部空间中的定位密封件可有助于防止密封件在组织压力作用下伸缩或者说是受其影响,并可防止组织封闭器械通道或者说是防止组织阻挡或降低通过器械通道的可见性。
参照图3和图4,所示插件2000包括插件组件。如以下更充分描述的,示出了插件组件包括外部本体部分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,其具有大体圆柱形的外表面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凸起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,以使得当将插件2000插入到挠性牵开器1000中时,外部本体部分2100没有变形到任意显著程度,而是相反起到将挠性牵开器拉伸或者说是伸展的作用以使通道1104保持所需的形状和尺寸,或者将通道设为预定的尺寸和形状。
可将所示外部本体部分2100插入到牵开器中以使牵开器的与环1200和1400分隔且在环1200和1400之间的部分变形。外部本体部分2100的尺寸和形状可使其穿过环1200和1400中的一者或两者,而不使环变形。例如,外部本体部分2100可具有大体圆柱形的外表面,该外表面的外径小于环1200的内径,外表面的尺寸可使其径向和周向拉伸牵开器与通道1104相连的部分。因此,插件2000可将延伸穿过切口的通道1104设置成具有预定直径的大体圆形的剖面。保留了容易插入挠性牵开器的优点,同时防止切口使通道1104变窄或收缩。另外,具有大体圆柱形构造的插件将穿过牵开器的大体圆形的开口设置成这样的圆,该圆提供每周边长度单位的最大面积。插件的大体圆形剖面还使得可易于使插件的一部分旋转,例如,相对于插件的外表面和/或牵开器旋转。
在一个实施例中,本体部分2100的外径尺寸可形成为比当在没有将插件2000设置在通道1104中牵开器自己站立时通道1104的内径稍微大。在将牵开器1000插入到切口中之后,可将插件2000插入到牵开器1000中。插件2000的尺寸可形成为拉伸牵开器以至少稍微扩大通道1104,并且插件2000可与通道1104的内表面摩擦接合。插件2000可用于使通道1104抵抗作用在牵开器1000上的切口的压缩力而保持打开。
示出了外部本体2100具有大体圆柱形的外表面,但是应当理解,可利用其它外表面形状,包括基本光滑的或者小平面化的外表面。合适的表面包括(但是不必限于)卵形、椭圆形、卵形、长方形及其组合。例如,可能有利的是,设置具有不同外表面形状和尺寸的各种插件,以根据(例如)正进行的手术和/或切口尺寸来设置或有助于设置具有特定尺寸和形状的通道1104。本体部分2100的外表面的尺寸和形状可用于使挠性构件变形,以将通道的至少一部分设置成预定的尺寸和形状。另外,外部本体部分的尺寸和形状可用于使外部本体部分2100与挠性牵开器中的通道1104的内表面摩擦接合。
仍参照图3和图4,内壳体2700包括近侧朝外的顶部表面2702,器械开口2014可延伸穿过顶部表面2702。所示内壳体2700还具有从顶部表面2702向远侧延伸的大体圆柱形的外侧表面2710。示出了器械沟槽构件2500被支撑在内部本体部分2700内。器械沟槽构件2500限定多个器械沟槽2550,每个沟槽2550与近侧开口2014大致对准,并从近侧开口2014延伸到远侧出口2016。示出了隔膜密封件2600存在于内壳体2700和器械沟槽构件2500的近端之间。隔膜密封件2600提供这样的密封件,其用于防止在将器械插入穿过开口之前通过器械开口2014的充气的损失。隔膜密封件2600可具有由可被外科手术器械击穿或者说是刺穿的挠性材料形成的薄隔膜的形式。在一个实施例中,密封件2600包括由聚氨酯形成的厚度小于约0.010英寸的隔膜,特别地,隔膜的厚度可为约0.006英寸。或者,可与开口2014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提供轴向推力支撑表面,在该表面上,可旋转地支撑支承构件2200(例如参见图3)。支承构件2200可用于为包括内侧本体部分2700和器械沟槽构件2500的组件提供旋转支撑,以使该组件能够相对于外部本体部分2100围绕轴70旋转,轴70大体纵向延伸穿过牵开器1000中的通道1104。支承构件2200可由任何合适的材料形成,所述材料例如是高密度聚乙烯。
因此,可以以下述方式设置支承构件2200,即,当将插件2000按压到挠性牵开器1000内的位置中时,外部本体部分2100可相对于牵开器1000保持大致静止,同时器械沟槽构件2500能够在牵开器内旋转。构件2500的旋转使得可对器械开口2014和通道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。
示出了器械沟槽构件2500包括多个器械沟槽2540,每个器械沟槽包括器械通道2550。有利的是,器械沟槽构件2500可形成为一体式由可变形弹性材料(例如聚异戊二烯、Kraton或Sanoprene)形成的一体结构,以使每个器械沟槽2540能够相对于与壳体2700和其它器械沟槽独立地变形。因此,可使插入到器械通道2550中的器械彼此成一定角度和/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。如果需要,可将密封构件2544或其它压缩物设在每个器械沟槽2540的远端,用于密封定位于器械沟槽2540内的器械。
在附图中,示出了器械沟槽2540的形状大体为圆柱形,并从近侧基座2510向远侧延伸。基座2510中的开口2514与器械开口2014对应,并通过形成在基座2510的上表面中的凹口2520使开口2514与器械开口2014大体对准。可将凹口2520定位成与内壳体2700的下侧(远侧)上的特征配合。
形成在外部本体部分2100的内表面中的凸起2114可与特征(例如,形成在内壳体2700的圆柱形外表面2710中的周向延伸的凹槽2714)在操作上接合。凸起2114与凹槽2714接合以相对于外部本体部分2100对内壳体2700进行轴向(即,沿近侧方向和远侧方向)约束,同时使得内部本体部分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凸起。
可设置倒置约束构件2300以防止当从器械沟槽2540取出器械时器械沟槽2540变成“倒置”(比如,以从里向外拉出的衬衫袖子的方式)。示出了构件2300具有大体盘形的本体2320,本体2320具有延伸从其穿过的孔隙2340。每个孔隙2340的尺寸可形成为与相应器械沟槽2540的远端配合。构件2300可由任何合适的材料形成,所述材料包括(例如)聚异戊二烯、Sanoprene或Kraton。可根据插件2000的多个近侧部分的挠性来定制构件2300的挠性。例如,如果使构件2300相比于插件2000的近侧部分(例如,壳体2700的顶部表面)更柔韧,则插入在器械沟槽中的器械往往会围绕与插件的更近侧的部分相连的支点枢转。或者,如果使构件2300相比于插件2000的更近侧部分更刚性,则器械往往会围绕与构件2300相连的支点枢转。如图3所示,可将构件2300轴向定位在支承构件2200和垫片2400之间,并可将构件2300径向定位在内壳体2700的远侧部分的内部。
图5和图6示出根据本发明的进入装置的可供选择的实施例。所示进入装置包括挠性组织牵开器1000、插件2000和套管3000的组件。挠性组织牵开器1000和插件2000可以是任何合适的形式,包括以上参照图1至图4所述的形式。
可设置套管3000来帮助防止插件2000被按压穿过牵开器1000进入到体腔中并有助于从牵开器1000移除插件2000。例如,在外科手术期间,可能有利的是,在组织牵开器1000中交换一个或多个插件,而不从切口移除组织牵开器1000。或不同的器械开口尺寸还可设置套管3000来保护牵开器1000不被插入穿过插件2000的器械戳破或者说是损坏。在一个实施例中,可为特定手术设置多个插件2000,每个插件具有不同形状、不同尺寸、不同数量的器械开口和/。或者,可能有利的是,从定位在切口中的牵开器移除插件2000,例如以通过组织牵开器1000的通道取出器械、设备、组织或身体器官。
参照图5和图6,套管3000可包括大体环形部分3100和大体圆柱形部分3200。示出了大体环形部分3100具有大体平坦的近侧(上)表面3110和相对的大体平坦的远侧(下)表面3120。当相对于牵开器3000和插件1000充分定位套管3000时,套管远侧表面3120可与挠性组织牵开器1000的近侧部分邻接或者说是接触或者面对。
示出了大体圆柱形部分3200从环形部分3100向远侧延伸,并与环形部分3100基本成直角。示出了大体圆柱形部分3200包括径向朝外的表面3210和朝内的表面3220。朝内的表面3220提供通道3104。大体圆柱形部分3200至少部分延伸穿过挠性组织牵开器1000,并且在图5和图6中,大体圆柱形部分3200延伸穿过牵开器1000以向远侧延伸超出牵开器1000的远端。
在图5和图6中,示出了插件2000被设置在由套管3000的大体圆柱形部分3200提供的通道3104内。示出了套管部分3200继而被设置在挠性组织牵开器1000内。在将组织牵开器定位在切口中之前或之后,可按任意期望的顺序组装插件2000、套管3000和挠性组织牵开器。例如,可将插件2000按压到套管3000中,然后能够在将牵开器定位在切口中之前或之后将套管/插件子组件按压到牵开器1000中。或者,可在将牵开器定位在切口中之前或之后将套管3000按压到或者说是插入到牵开器中,然后可将插件按压到套管中。
一般来讲,首先将组织牵开器1000插入到切口中,例如通过使环1200/1400中的一者或两者变形来将牵开器插入在切口中,或者通过使用插入工具将牵开器插入在切口中。然后例如通过将套管按压到牵开器中,可将套管3000插入到牵开器1000中。然后可将插件2000插入到套管3000中。
示出了套管3000具有这样的构件,例如用于防止插件被按压完全穿过套管/牵开器进入到体腔中和有助于从牵开器移除插件2000的保持特征。参照图6,示出了大体周向延伸的凸缘或边缘3300形式的保持特征在套管3000的大体圆柱形部分3200的远端处大体向里径向延伸。边缘3300可以是周向连续,其尺寸和形状可使其与插件的一部分邻接地接合,所述插件的一部分例如是外部本体部分2100的远端。
在图5和图6所示的实施例中,当将插件2000和套管3000完全插入在牵开器1000内时,将密封件2544定位在牵开器1000的远端的下方。这样的布置可将器械枢转点设置在牵开器下方和体腔内。
如果需要,可沿近侧方向从图5和图6所示的完全插入构造中部分取出插件2000和/或套管3000,以相对于牵开器1000重新定位插件2000的远端。因此,外科手术器械退出插件2000的位置可沿着轴70以大体连续的方式改变,并可将器械退出插件2000的点定位在由牵开器提供的通道内的多个位置处或者在远侧定位在牵开器的远端的下方。
如果需要,套件可设有不同的插件2000、不同的组织牵开器1000和/或不同的套管3000。例如,套件可包括多个组织牵开器1000,针对不同的切口尺寸来形成每个组织牵开器1000的尺寸和/或形状。套件可包括器械开口尺寸和/或构造不同的多个插件2000。套件可包括具有长度和/或直径不同的大体圆柱形部分的套管。
为了从牵开器1000和切口取出插件2000,可用一个或两个手(例如在环形部分3100的相对侧)抓紧套管3000的一部分,例如环形部分3100,并可向近侧拉出套管(图5和图6中的向上方向)以从组织牵开器1000取出套管3000和插件2000。
套管3000可由非金属塑料或弹性材料形成。套管3000的厚度可以是约0.004英寸至0.025英寸,可由摩擦相对低、耐穿刺性高的材料形成套管3000,所述材料具有裂开之前相对高的延伸率,并且套管3000对有机硅或其它润滑剂有相对高的抵抗力而不分解或降解。一个合适的套管3000可由厚度为约0.005英寸至约0.007英寸的薄板或膜形成。套管3000的摩擦系数可形成为小于牵开器1000的摩擦系数,并且套管3000的摩擦系数可小于约0.25,更特别地,小于约0.20,还更特别地,小于约0.15。
在一个实施例中,套管3000可由相对刚性的非金属塑料或弹性材料形成,所述材料的硬度大于组织牵开器的硬度,挠性低于组织牵开器的挠性。在另一个实施例中,套管可由相对软和挠性的材料形成。一种合适的可以形成套管3000的材料为热塑性聚氨酯弹性体,例如可得自陶氏化学品公司(Dow Chemical)的Pellethane牌聚氨酯。
可设置多个插件2000,例如,可以以套件形式设置两个、三个或更多个插件来用于单个外科手术操作。例如,第一插件可被设置成具有两个或更多个器械开口,第二插件也可被设置成具有多个器械开口。第一插件和第二插件可具有相同数量的器械开口或者不同数量的器械开口。
图7是与图4所示插件类似的插件2000的示意性分解图,但是与图1所示的四个器械开口不同,该插件2000具有三个器械开口2600。在图7中,三个器械开口包括一个相对大的器械开口(例如用于容纳腹腔镜或其它直径相对大的装置)和两个相对小的器械开口(例如用于容纳相对小的装置,诸如5mm的抓紧器、施夹钳等)。如图7所示,器械沟槽构件2500具有与三个器械开口相应的三个器械沟槽,示出了器械沟槽之一的直径比另两个器械沟槽的直径大。图7的插件2000的形状和直径可与图1的插件2000的形状和直径大体相同。或者,如果需要,插件可具有不同的直径和/或不同的形状。
图8是可如何将图7中的插件插入到套管3000(示出了一半截面)中继而可将插件2000和套管3000插入到挠性组织牵开器1000(也示出了一半截面)中的示意性描绘。如上所述,套管3000可包括大体周向延伸的凸缘或边缘3300形式的保持特征,示出了凸缘或边缘3300在套管3000的大体圆柱形部分3200的远端处大体向里径向延伸。边缘3300可以是周向连续的,其尺寸和形状可形成为与插件的一部分邻接地接合,所述插件的一部分例如是插件的外部本体部分2100的远端。如果需要,套管3000可由相对有弹性的材料形成,套管3000的部分3200的内径的尺寸可形成为与插件的外表面接合(例如通过使直径比插件2000稍微小),以使可以以可脱开的方式将插件定位在部分3200内的多个插入深度处。以这种方式,能够相对于挠性组织牵开器将插件2000定位在多个插入深度处,特征3300可用于防止插件被不利地推压到体腔中。
图9示出设置在组织60中的切口中的组织牵开器1000,此时,插件2000以可脱开的方式被支撑在套管3000中,套管3000继而以可脱开的方式被支撑在组织牵开器1000内。示出了插件2000被设置在套管3000的远端,此时,插件的远端与套管的构件/保持边缘3300邻接。
图9还示出套管3000的轴向长度可比牵开器1000的轴向长度长。如果需要,可将套管定位在牵开器内的各种深度处,以使可将套管的远端(比如,圆柱形部分3200的远端)定位在牵开器的远端的近侧或远侧。在图9中,示出了套管的远端设置在组织牵开器1000的远端的远侧(下方),以使得插件2000的器械出口2016定位在腹壁下方。保持特征(比如,边缘构件3300)防止插件被无意地推压到腹腔60A中。当从挠性牵开器1000近侧取出套管3000时,特征3300还有助于将插件2000与套管3000一起移除。因此,能够在移除承载插件的套管3000之后将牵开器留在切口中。
图10是示出在套管3000承载和保持插件的情况下可如何通过用单手的手指抓紧套管3000的部分3100的边沿从近侧提起套管(图10中的向上方向)来移除套管3000和插件2000的透视图。示出了当从牵开器1000取出套管时将插件与套管一起移除,并且牵开器留在组织60中的切口中适当的位置上。
图11是透视图,其示出了如何实现一旦从由挠性牵开器1000提供的通道移除套管3000和插件2000就可通过挠性牵开器1000的通道从体腔(比如,腹壁60A)向近侧(图11中的向上方向)移除标本和/或标本袋5000,例如将抓紧器械6000插入穿过牵开器的通道来移除标本和/或标本袋5000。
图12示出将插件2000设置在挠性牵开器1000内而不使用套管3000的实施例的示意性剖视图。示出了挠性牵开器1000具有内肋或边缘1108形式的内部保持特征,其用于将插件2000保持在牵开器内的所需深度处。在图12中,示出了将边缘1108定位在沿着由牵开器1000提供的通道的长度的中间,以使将插件2000的远端设置在沿着牵开器的通道的长度的中间。
图12示出插件在挠性牵开器1000内的挠性支撑如何使得延伸穿过插件2000的器械沟槽的器械7000(比如,腹腔镜或用于操纵/抓紧组织的器械)可被用于使插件2000自身枢转,以得到与由安装在牵开器上方或下方的器械支撑件和密封件提供的运动范围相比有所改进的器械运动范围。
图13提供包括插件2000、套管3000和牵开器1000的组件的示意性剖面图,其中,插件包括与器械进入沟槽的近端相连的鸭嘴密封件2630形式的零闭合密封件(用于当没有器械插入穿过沟槽时密封器械进入沟槽)和在操作上与器械进入沟槽的远端相连的隔膜密封件2640形式的器械密封件,该器械密封件用于密封插入到器械沟槽中的器械。或者,可将密封件2640设在插件的近端,并可将密封件2630设在插件的远端。
本文所公开的器械可被设计为单次使用后丢弃,或者它们可被设计为可使用多次。然而无论是哪种情况,该装置都能够在至少使用一次后经过修复再行使用。修复可包括以下步骤的任何组合:拆卸装置,然后清洗或更换特定零件,以及重新组装。具体地讲,可拆卸该装置,并且可按照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,可到修理厂或在临外科手术前由手术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装置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,获取新的或用过的器械,并根据需要进行清洗。然后对器械进行消毒。在一种消毒技术中,将器械置于闭合并密封的容器中,例如塑料或TYVEK口袋中。然后将容器和器械置于可穿透该容器的辐射场,例如γ辐射、X射线或高能电子。辐射将杀死器械上和容器中的细菌。然后可将消毒后的器械保存在消毒容器中。该密封容器将器械保持在无菌状态,直到在医疗设备中打开该容器。
优选对装置进行消毒。这可以通过本领域技术人员已知的多种方法来完成,包括β或γ辐射、环氧乙烷、蒸汽以及液浴(如冷浸)。
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。
Claims (39)
1.一种医疗装置,包括:
组织牵开器,所述组织牵开器包括挠性构件,所述挠性构件具有用于与身体切口接合的外表面和限定通道的内表面;和
插件,所述插件以可脱开的方式被支撑在由所述挠性构件限定的所述通道内,其中所述插件包括至少一个器械开口。
2.根据权利要求1所述的医疗装置,其中所述插件包括外表面,所述外表面的尺寸和形状形成为使所述挠性构件变形以将所述通道的至少一部分设置成预定的尺寸和形状。
3.根据权利要求1所述的医疗装置,其中所述插件包括大体圆柱形外表面,所述大体圆柱形外表面的尺寸形成为当将所述插件插入在所述通道内时径向拉伸所述挠性构件,以得到具有预定直径的大体圆形的剖面。
4.根据权利要求1所述的医疗装置,其中所述插件包括多个器械开口。
5.根据权利要求1所述的医疗装置,其中所述插件包括具有外侧部分和内侧部分的组件,并且其中所述内侧部分能够相对于所述外侧部分旋转。
6.根据权利要求1所述的医疗装置,其中所述插件的外侧部分与所述挠性构件的内表面摩擦接合。
7.根据权利要求1所述的医疗装置,包括用于约束所述插件进入到体腔中的轴向运动的特征。
8.一种医疗装置,包括:
挠性组织牵开器,所述挠性组织牵开器具有用于与身体切口接合的外表面和限定身体进入通道的内表面;和
插件,所述插件适于被插入到所述挠性组织牵开器内,所述插件包括:
外部套管,所述外部套管的尺寸和形状形成为与所述挠性组织牵开器的所述内表面的一部分接合并使这部分变形;
壳体,所述壳体至少部分设置在所述外部套管内,所述壳体具有包括多个器械开口的上表面;和
至少一个密封件,所述至少一个密封件与每个器械开口相连。
9.根据权利要求8所述的医疗装置,其中所述插件还包括器械沟槽构件,所述器械沟槽构件包括多个管状器械沟槽,每个管状器械沟槽基本上与所述壳体中的器械开口对准。
10.根据权利要求9所述的医疗装置,其中所述壳体和所述器械沟槽构件能够相对于所述外部套管被可旋转地支撑。
11.根据权利要求10所述的医疗装置,其中所述器械沟槽构件包括一体式挠性结构,并且其中每个管状器械沟槽能够相对于所述壳体和其它管状器械沟槽独立地变形。
12.根据权利要求11所述的医疗装置,还包括具有多个从其穿过的开口的倒置约束构件,并且其中管状器械沟槽轴向延伸穿过所述倒置约束构件的每个开口。
13.一种医疗装置,包括:
挠性组织牵开器,所述挠性组织牵开器具有第一末端、第二末端和在所述第一末端和所述第二末端之间延伸的挠性构件;和
插件,所述插件包括多个器械开口,所述插件适于以可脱开的方式插入在所述挠性组织牵开器的所述第一末端和所述第二末端之间的所述挠性构件内;
其中所述挠性组织牵开器包括与所述挠性组织牵开器的所述第一末端相连的第一可变形环和与所述挠性组织牵开器的所述第二末端相连的第二可变形环;和
其中所述插件的尺寸和形状形成为使所述第一可变形环和所述第二可变形环之间的所述挠性构件的一部分变形。
14.根据权利要求13所述的医疗装置,其中所述插件的尺寸形成为穿过所述第一可变形环而不使所述第一可变形环发生变形。
15.一种医疗装置,包括:
挠性组织牵开器,所述挠性组织牵开器具有用于与身体切口接合的外表面和限定通道的内表面;
套管,所述套管的至少一部分能够定位在所述通道内;和
插件,所述插件包括至少一个器械开口,其中所述插件适于以可脱开的方式被支撑在所述通道中。
16.根据权利要求15所述的医疗装置,其中所述套管的至少一部分被设置在所述挠性组织牵开器的内表面的一部分和所述插件的一部分之间。
17.根据权利要求15所述的医疗装置,其中所述套管包括大体圆柱形部分,所述大体圆柱形部分的尺寸使其定位在所述挠性构件的一部分和所述插件的一部分之间的所述通道内。
18.根据权利要求15所述的医疗装置,其中能将所述插件和所述套管一起从所述挠性组织牵开器的所述通道移除。
19.根据权利要求15所述的医疗装置,其中所述套管能定位在所述插件的外表面和所述挠性构件的内表面的一部分之间的所述通道中,并且其中所述套管包含硬度比所述插件的外表面的硬度低的材料。
20.根据权利要求15所述的医疗装置,其中所述套管包括用于约束所述插件穿过所述套管的轴向运动的特征。
21.根据权利要求15所述的医疗装置,其中所述套管的轴向长度比所述插件的轴向长度长。
22.根据权利要求15所述的医疗装置,其中所述套管的轴向长度比所述牵开器的所述通道的轴向长度长。
23.一种穿过切口进入体腔的方法,所述方法包括以下步骤:
将组织牵开器定位在所述切口中;
以可脱开的方式将具有多个器械开口的插件定位到所述组织牵开器中。
24.根据权利要求23所述的方法,其中所述定位插件的步骤包括将所述插件按压到所述组织牵开器中。
25.根据权利要求23所述的方法,其中所述定位插件的步骤包括使所述组织牵开器的至少一部分变形。
26.根据权利要求23所述的方法,还包括从所述组织牵开器移除所述插件而不从所述切口移除所述组织牵开器的步骤。
27.一种进入体腔的方法,所述方法包括以下步骤:
形成切口;
将组织牵开器定位在所述切口中;
定位套管以使其至少部分延伸在所述组织牵开器内;和
将具有至少一个器械开口的插件定位到所述套管中。
28.根据权利要求27所述的方法,其中在将所述套管插入到所述牵开器中的步骤之前,执行所述将所述组织牵开器定位在所述切口中的步骤。
29.根据权利要求27所述的方法,还包括移除所述插件而不从所述切口移除所述组织牵开器的步骤。
30.根据权利要求27的方法,还包括将所述插件和所述套管一起从所述组织牵开器移除的步骤。
31.一种医疗装置,其包括:
组织牵开器,所述组织牵开器包括挠性构件,所述挠性构件具有用于与身体切口接合的外表面和限定通道的内表面;和
至少一个插件,所述至少一个插件具有至少一个器械开口,所述插件以可脱开的方式被支撑在由所述挠性构件限定的所述通道内;并且
其中所述插件能被定位在由所述挠性构件限定的所述通道内的不同插入深度处。
32.根据权利要求31所述的医疗装置,其中所述插件能够定位在一插入深度处,其中所述插件的近端被定位在所述挠性构件的近端的远侧。
33.根据权利要求31所述的医疗装置,其中所述插件能够定位在一插入深度处,其中所述插件的远端被定位在挠性构件的远端的远侧。
34.根据权利要求31所述的医疗装置,其至少包括第一插件和第二插件,每个插件能够以可脱开的方式支撑在所述通道内,这些插件能够彼此互换。
35.根据权利要求34所述的医疗装置,其中,所述第一插件和第二插件能够在所述通道内互换,而不从所述身体切口移除所述挠性构件。
36.一种穿过切口进入体腔的方法,所述方法包括以下步骤:
将挠性组织牵开器定位在所述切口中,其中所述组织牵开器提供延伸穿过所述切口的通道;
将具有至少一个器械开口的第一插件以可脱开的方式定位在由所述挠性组织牵开器提供的所述通道中;
从由所述组织牵开器提供的所述通道移除所述第一插件;
将具有至少一个器械开口的第二插件定位在所述通道中。
37.根据权利要求36所述的方法,其中所述定位第一插件和第二插件中的至少一个的步骤包括将插件按压到所述组织牵开器中。
38.根据权利要求36所述的方法,还包括将可移除的套管定位在所述通道内的步骤,其中所述套管的至少一部分被设置在插件和所述挠性组织牵开器的一部分之间。
39.一种穿过切口进入体腔的方法,所述方法包括以下步骤:
将挠性组织牵开器定位在所述切口中,其中所述组织牵开器提供延伸穿过所述切口的通道;
将具有至少一个器械开口的插件以可脱开的方式定位在由所述挠性组织牵开器提供的所述通道中的第一深度处;和
将所述插件重新定位到所述通道中的第二深度处。
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CN111789604A (zh) * | 2019-04-05 | 2020-10-20 | 西门子医疗有限公司 | 导引单元、导引系统、设备、计算机程序产品和方法 |
CN112370172A (zh) * | 2020-09-18 | 2021-02-19 | 象山县第一人民医院医疗健康集团 | 一种胸腔镜用机械手臂 |
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CA2698059C (en) | 2017-09-12 |
EP2238926A3 (en) | 2015-04-22 |
EP2238926A2 (en) | 2010-10-13 |
CN101849848B (zh) | 2014-03-26 |
CN101849847B (zh) | 2014-05-14 |
JP5717974B2 (ja) | 2015-05-13 |
KR20170001946A (ko) | 2017-01-05 |
KR101734065B1 (ko) | 2017-05-11 |
AU2010201024A1 (en) | 2010-10-14 |
AU2010200982A8 (en) | 2016-01-28 |
AU2010201024B2 (en) | 2015-05-14 |
CA2698059A1 (en) | 2010-09-30 |
US20100249525A1 (en) | 2010-09-30 |
JP2010240405A (ja) | 2010-10-28 |
US8357085B2 (en) | 2013-01-22 |
KR20100109480A (ko) | 2010-10-08 |
AU2010200982A1 (en) | 2010-10-14 |
JP2010240404A (ja) | 2010-10-28 |
CN101849847A (zh) | 2010-10-06 |
JP5638270B2 (ja) | 2014-12-10 |
AU2010200982B2 (en) | 2016-01-21 |
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