CN1764416A - 用于内窥镜结肠切除术的设备和方法 - Google Patents

用于内窥镜结肠切除术的设备和方法 Download PDF

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CN1764416A
CN1764416A CNA028269608A CN02826960A CN1764416A CN 1764416 A CN1764416 A CN 1764416A CN A028269608 A CNA028269608 A CN A028269608A CN 02826960 A CN02826960 A CN 02826960A CN 1764416 A CN1764416 A CN 1764416A
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阿米尔·贝尔森
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Abstract

在这里披露了用于内窥镜结肠切除术的设备和方法。具有第一和第二组织接近装置的结肠切除装置(102)相互分开地安装在结肠镜(100)上。在结肠切除装置(102)的展开期间，将结肠的患病部分设置在组织接近装置之间。该组织接近装置(104，106)径向膨胀，从而它们在与结肠的患病部分相邻的两个位置处接触并且抓住结肠壁。使患病部分与网膜分开，并且采用腹腔镜横切或者吸进结肠镜(100)以便随后除去。然后在结肠镜(100)上将这些组织接近装置(104，106)朝着彼此推压以使结肠的两个自由边缘接触在一起，其中采用作为外科订书器的组织接近装置将它们相互紧固在一起以形成端部到端部吻合。

Description

用于内窥镜结肠切除术的设备和方法
本申请要求了于2002年1月9日提交的美国临时专利申请序列号No.60/347674的优先权，该文献的全文在这里被引用作为参考。
技术领域
本发明大体上涉及外科手术方法和设备。更具体地说，本发明涉及用于进行内窥镜结肠切除手术的方法和设备。
背景技术
内窥镜手术通过借助嘴或肛门进行内腔的套管插入术来研究包括食道、胃和结肠的上下肠的中空器官的腔间方面。内窥镜息肉切除术目前限于粘膜下层切除术。内窥镜手术者往往不能完全切除固着息肉或病变，因此病人随后还要进行最后手术，即切除肿瘤的基底。内窥镜息肉切除术可以用来切除大部分固着的肿块，但是它不能切除壁层腹膜疾病。固着息肉的不完全切除可能会破坏活检标本，并且改变送给病理学家的初标本，由此使得病理学家可能会作出不正确或者不完全的研究结果。内窥镜手术者也不能纠正少见的但是会威胁生命的例行并发症例如穿孔。其它需要切除的情况是侵袭性肿瘤、各种原因导致的穿孔、发炎性肠道疾病、肠憩室病等。
广泛采用的用于切除生病组织的外科手术方法是，形成大的剖腹切口，或者采用最小的侵入性技术，例如腹腔镜外科手术，在这种手术中，通过小的切口来对组织进行切除和修复。
有多种外科手术设备使外科手术大夫能够通过传统的切口或者使用腹腔镜并形成一个或者多个较小切口来切除生病的组织以及然后吻合剩余的组织。另外，已经知道内窥镜辅助的订书设备，它使得外科手术大夫能够远距离的吻合内腔结构例如肠道。但是内窥镜辅助的肠道吻合通常仍然需要借助于通常的剖腹切口或采用腹腔镜来进行内腔外的帮助。
包括腹腔镜胆囊切除术、腹腔镜阑尾切除术、腹腔镜辅助的局部结肠切除术和疝气修复在内的进展显示了外科手术朝着小的侵入性疗法发展的趋势。所有的这些小侵入性疗法涉及将腹腔镜穿过腹壁引入，并形成其它相关的开口以能够进出腹膜腔，从而进行必要的外科手术治疗。通常需要全身麻醉。可以采用内窥镜的疗法包括息肉切除术、粘膜切除术以及烧灼。在“内窥镜结肠切除术”中，目前采用腹腔镜将结肠从它的网膜上分离，然后将结肠取出至腹膜腔之外，通过内窥镜切口在体外进行切除和吻合。
腹腔镜方法的缺点包括需要穿过腹壁，由于减少了暴露而导致操作时间增加，并可能在进行治疗的过程中需要转变为“开放式”的剖腹切口。
外科手术中目前的订书技术在极大程度上能具有适当的功效，但是仍然是有局限性的。目前已有的设备包括GIA和EEA订书机，它们可以用于分别以线或者圆圈的方式横切组织，然后利用订书钉进行吻合。线性GIA比较通用。EEA主要适用于在已经采用外科手术(剖腹或者腹腔镜)除去了病变之后或者在结肠切除术拆卸疗法中进行下结肠圆圈吻合。
EEA订书机的刚性柱严格限制了它的使用，还需要采用开放式疗法。可转向内窥镜订书机用于获得更多的肠道可接近性。但是它在应用之前仍然依赖于横穿腹部的外科暴露。腹腔镜外科手术仪器已经用于肠道吻合，在这种疗法中，通过腹腔镜切口来取出肠道，并从体外吻合或者以增强并排订上的方式吻合。
US5868760和6264086描述了一种进行组织的腔内切除、尤其是用于除去病人结肠的生病部位的方法和装置。这种结肠切除术的纯腔内方法不完全致力于结肠的外科解剖学。如人们所知道的那样，结肠和其它内脏在腹部内由网膜、承载着对结肠的血液供应的腹膜的膜性延伸来连接和支撑。结肠的小部分以上的切除需要结肠从网膜移动并结扎或者烧灼作为结肠一部分的血管供应。这一方面不是上述腔内方法所侧重的；因此它仅适合于切除结肠的小部分。
2001年2月20日提交的同一所有人的未决US专利申请序列号09/790204(目前是US6468203)；2001年10月2日提交的09/969927；以及2002年8月27日提交的10/229577描述了可转向的结肠镜，它采用蛇形的移动以便于快速和安全的将结肠镜插入到病人的结肠中。此处描述的技术也可以与本发明的方法和装置结合使用，以便于内窥镜结肠切除术或者切除肠胃系统的任何其它部分，包括但不限于食道、十二指肠、空肠以及回肠或者任何其它的管状器官，例如支气管。这些专利和专利申请以及此处提到的所有其它专利和专利申请其全文在此引入作为参考。
发明内容
根据上面的说明，本发明采取了用于进行内窥镜结肠切除术的方法和设备，它们结合了腹腔镜和内窥镜方法的优点。采用腹腔镜和/或结肠镜技术或采用另一种成像方式来识别出所要切除的结肠的患病部分。安装在结肠镜上的结肠切除装置在与结肠的患病部分相邻的两个位置处抓住结肠壁。采用腹腔镜技术，使结肠的患病部分与网膜分开，并且绑扎或烧灼给它供血的血管。切割结肠壁以除去患病部分，并且采用腹腔镜取出切除部分或者吸到结肠切除装置中以便随后在结肠镜撤回时取出。结肠切除装置靠近结肠的两个端部并且进行端部到端部连接。如果所要切除的部分为肿瘤，则在切除之前将钉住所要切除的段的边缘以将它密封并且防止恶性细胞溢出到健康组织上。
本发明的方法和设备为结肠切除术提供了许多现有技术不能实现的优点。如上所述，纯粹的内窥镜方法不能使结肠与网膜分离，这在不仅仅是切除结肠的一小部分时是必要的。通过将腹腔镜技术与安装有结肠镜的结肠切除装置结合，从而本发明克服了在现有技术中的这个缺陷，由此使得结肠切除术具有更全面的方法。但是，与现有技术腹腔镜技术不一样，结肠不必从腹腔中取出以便切除患病不服那或者吻合剩下的结肠。安装有结肠镜的结肠切除装置靠近结肠的端部，并且从结肠内腔的内部进行吻合。可以将切除组织吸到结肠切除装置中以便通过结肠的内腔与结肠镜一起取出，或者可以通过腹腔镜取出，这可以通过在病人皮肤中的非常小的切口来完成。该现有技术方法也不能防止恶性细胞向周围泄漏。这个构思使得能够在其两个端部处用U形钉将组织密封以便防止这种泄漏。可选的是，它可以利用用作砧座的腹腔镜装置的帮助来实现。与现有技术过程不同，本发明在装订之前将可选使用在结肠或任意其它切除器官的内腔中充气的气球，并且由此确保在这些边缘最佳可能接近的情况进行理想的吻合。
在本发明使用结肠镜技术提供了另一个不能由纯粹的腹腔镜方法实现的优点。由于结肠镜检查目前是用于识别结肠疾病的最有决定性的诊断方法，从而通过腹腔镜书或甚至通过直接目测来通过结肠外部定位器官损害会稍微有些问题。使用结肠镜来识别结肠的患病部分并且使之与内腔内部分离这确保了，切除了结肠壁的正确部分，并且制作出干净的手术区域，并且同样更取保了没有残余疾病。
在一优选实施方案中，本发明利用了一种如在美国专利申请序列号Nos.09/790204(现在为美国专利No.6468203)；09/969927；以及10/229577中所述的可操纵结肠镜，每篇文献其全文在这里被引用作为参考。在这里所述的可操纵结肠镜为进行根据本发明的内窥镜结肠切除术提供了许多额外的优点。该可操纵结肠镜采用蛇行运动，以便于安全迅速地将结肠镜插入到病人的结肠中，这使得能够更加迅速安全地进行该内窥镜结肠切除方法。但是此外，该可操纵结肠镜能够构造出结肠和在初始检查其间所识别出的任意器官损害的位置的三维数学模型或图。也可以将在前面检查期间由CT、MRI或任意其它成像技术找到的器官损害绘制到结肠的三维数学模型上。通过产生结肠的三维图，从而该系统知道内窥镜的每个部分在结肠中的位置并且能够正确地将切除和装订系统的两个部分定位在所要求的位置中。在手术期间，可以使用该信息来迅速精确地使结肠镜返回到所识别出的器官损害位置，在那里将使用该安装有内窥镜的结肠切除装置来完成内窥镜结肠切除过程。
附图说明
图1为一幻想图，显示出通过在病人的腹部中的小切口采用腹腔镜技术使结肠的患病部分与网膜分离。
图2为一剖面图，显示出插入穿过病人的结肠内腔具有安装在其上的结肠切除装置的可操纵结肠镜。
图3为一剖视图，显示出在结肠内腔内扩展的安装有结肠镜的结肠切除装置的夹持机构。
图4显示出在已经使用处于适当位置中的安装有结肠镜的结肠切除装置将患病部分切除至该结肠的大致横切端部处。
图5显示出进行端部到端部连接以完成该内窥镜结肠切除过程的安装有内窥镜的结肠切除装置。
具体实施方式
图2为一剖视图，显示出插入穿过病人结肠的内腔的具有安装在其上的结肠切除装置102的可操纵内窥镜100。如上所述，该技术同样适用于其它管状器管优选的是，可操纵结肠镜100如在美国专利申请序列号Nos.09/790204(现在为美国专利No.6468203)；09/969927和10/229577中所述一样构成，它具有多个铰接段，它们被控制成以一种蛇行的运动方式运动，这便于在结肠壁上施加最小的接触和应力的情况下插入和撤回结肠镜。另外，可操纵结肠镜100的控制系统在它在操作人员的控制下前进穿过内腔时能够构造出结肠的三维数学模型。可以将结肠的三维数学模型和在初始结肠镜检查的过程中识别出的任何器官损害的位置和特性存储并且用于进行内窥镜结肠切除术。在可选实施方案中，本发明的结肠切除装置102可以安装在具有不同设计和结构的结肠镜上。
该结肠切除装置102可以永久或者可拆卸地安装在可操纵结肠镜100上。结肠切除装置102具有一远端部件104和一近端部件106。该远端部件104和近端部件106每个都具有一可膨胀部件108和用于夹着结肠壁的夹持机构110。该可膨胀部件108可以为一可充气气球或可机械膨胀的机构。该夹持机构110可以包括多个位于圆周上的端口，在这些端口内围绕着可膨胀部件108的外表面可以可收缩地设置安装位置112例如针、钩、倒钩等。或者，夹持机构110可以利用穿过围绕着远端部件104和/或近端部件106的多个位于圆周上的端口的真空夹持器或其它已知的夹持机构。在真空夹持器的情况中，夹持机构110通过端口并且通过结肠镜100与通向真空泵(未示出)的结肠镜100的近端连通。远端部件104和近端部件106中的至少一个(可选为两个)可以相对于可操纵结肠镜100的主体纵向运动。在可操纵结肠镜100上可以设有导轨、导槽等114，用来引导远端部件104和近端部件106的纵向运动。
另外，结肠切除装置102包括一外科订书机116或其它连接机构。外壳装订器116装载在远端部件104或近端部件106上，并且订书机砧座118装在这些部件中的另一个上。该外科订书机116同样可以构成为任何数量的普通装订装置，它们用来将卡钉订进组织中。另一个可选方法为，在两个部件上都具有装订机和砧座用来装订和密封边缘。可选的是，该结肠切除装置102可以包括一切割装置和/或电烙器和/或用于横切结肠壁的激光装置。可选的是，结肠切除装置102还可以包括一真空机构等，用来将切除的组织吸进结肠切除装置102中以便随后与可操纵结肠镜100一起除去。
图2显示出在收缩或泄气状态中以便穿过病人结肠的内腔的具有远端部件104和近端部件106的可膨胀部件108的可操纵结肠镜100。该可操纵结肠镜100的控制系统在它在结肠内前进时监测结肠镜100的每段的位置并且当装有结肠切除装置102的远端部件104和近端部件106的段相对于结肠内的先前所检测到的器官损害正确定位时给操作人员发信号。或者，可以将可操纵结肠镜100的控制系统编程以使结肠镜100自动地前进穿过结肠的内腔并且在结肠切除装置102的远端部件104和近端部件106相对于在结肠中的器官损害正确定位时使之停止。或者，该控制系统能够在结肠镜已经插入到结肠中之后自动地将两个部件引导至所要求的位置。
图3为一剖视图，显示出在结肠内腔中膨胀从而夹持机构110抓住结肠壁的装有结肠镜的结肠切除装置102的远端部件104和近端部件106的可膨胀部件108。远端部件104和近端部件106可以通过任意数量的膨胀装置膨胀。例如，它们可以在辐条状支撑结构下径向膨胀，或者它们可以构成为以旋转运动径向膨胀直到获得所要求的膨胀直径。在这一点上，通过安装有结肠镜的结肠切除装置102识别并且隔离结肠的患病部分，使该患病部分与网膜分开，并且采用腹腔镜技术将给它供血的血管绑扎和/或烧灼。图1为一假象图，显示出采用腹腔镜技术通过在病人腹部中的小切口而将结肠的患病部分与网膜分离。
接下来，通过在患病部分的近端和远端处横切该结肠来将结肠的患病部分切除。采用腹腔镜技术或采用安装在结肠切除装置102上的切割机构和/或电烙装置横切该结肠。采用腹腔镜将所切除的组织除去，或者将它吸进结肠切除装置102以便随后在可操纵结肠镜100回撤时除去。图4显示出在已经用处于靠近结肠的横切端部附近位置中的安装有结肠镜的结肠切除装置102切除之后的结肠。
通过如由箭头所示一样使远端部件104和/或近端部件106相对于可操纵结肠镜100的主体纵向运动来使结肠的剩下端部相互靠近。可选的是，近端部件106可以朝着远端部件104纵向移动或者这两个部件104、106可以同时朝着彼此靠近。采用在结肠切除装置102上的外科订书器116和订书器砧座118将结肠的端部相互钉在一起以形成端部到端部的吻合120。一旦已经使组织的端部靠近，可以通过外科订书器116促动卡钉或其它紧固器件例如夹子、螺钉、粘接剂、缝线及其组合等，从而它们抵靠着订书器砧座118穿过组织的两个端部。图5显示出安装有结肠镜的结肠切除装置，用来进行端部到端部吻合120以完成该内窥镜结肠切除过程。一旦已经完成了吻合120，远端部件104和近端部件106的可膨胀部件108放气胀或收缩并且从病人身体充将可操纵结肠镜100和结肠切除装置102撤回。这些膨胀部件将确保非常精确的端部到端部吻合，并且防止由于两个端部的不精确靠近而出现的狭窄。
在采用安装有结肠镜的结肠切除装置102的备选方法中，在患病部分的端部已经靠近并且吻合之后，可以使用在结肠切除装置102内的切割装置来切除该结肠的患病部分。可以将切除的组织吸进结肠切除装置102中，并且在从病人身体中将可操纵结肠镜100撤回时取出。
在另一个备选方法中，采用安装有结肠镜的结肠切除装置102不用腹腔镜的帮助完全用内腔方法进行结肠切除术。该方法对于切除小部分结肠而言尤为有利，其中不必使结肠的延伸部分从网膜运动以实现成功的靠近和吻合。可操纵结肠镜102的三维绘图能力可以精确定位以前所标识出的器官损害而不用腹腔镜的帮助。
虽然在这里已经参照用于实施本发明的示例性实施方案和最佳模式对本发明进行了说明，但是对于本领域普通技术人员显而易见的是，在不脱离本发明的精神和范围的情况下可以作出许多改变、改进以及这些不同实施方案、改进和变化的再组合。

Claims (20)

1.一种内窥镜装置，用于接近位于中空身体器官内的组织，所述装置包括：
一细长体，它具有多个可铰接段和一可操纵远端，其中每个段可以构成为在细长体向远端或向近端行进时沿着任意路径呈现出所选择的形状；
设置在细长体周围的第一组织接近部件，其中第一部件能径向膨胀并且将组织的第一区域附着到围绕着第一部件圆周设置的多个组织夹持区域上；以及
在第一部件的近端处设置在细长体周围的第二组织接近部件，其中第二部件能径向膨胀并且将组织的第二区域附着到围绕着第二部件圆周设置的多个组织夹持区域上，
其中所述第一部件和第二部件能使所述第一区域接近组织的第二区域并且牢牢地将第一区域固定到第二区域上。
2.如权利要求1所述的内窥镜装置，其中所述第一和第二组织接近部件每一个都包括一可径向膨胀的环。
3.如权利要求1所述的内窥镜装置，其中所述第一和第二组织接近部件每一个都包括一可径向膨胀的气球。
4.如权利要求1所述的内窥镜装置，其中在第一和第二组织接近部件中的每一个上的所述多个组织夹持区域包括真空端口。
5.如权利要求1所述的内窥镜装置，其中在第一和第二组织接近部件中的每一个上的所述多个组织夹持区域包括可收缩紧固件。
6.如权利要求5所述的内窥镜装置，其中所述可收缩紧固件选自由针、钩和倒钩构成的组。
7.如权利要求1所述的内窥镜装置，其中所述第一组织接近部件能在沿着细长体形成的导轨或凹槽内沿着至少一部分细长主体朝着第二组织接近部件纵向滑动，从而使第一区域靠近组织的第二区域。
8.如权利要求1所述的内窥镜装置，其中所述第二组织接近部件能在沿着细长体形成的导轨或凹槽内沿着至少一部分细长主体朝着第一组织接近部件纵向滑动，从而使第一区域靠近组织的第二区域。
9.如权利要求1所述的内窥镜装置，其中所述第一和第二组织接近部件每一个都能在沿着细长体形成的导轨或凹槽内沿着至少一部分细长主体朝着彼此纵向滑动，从而使第一区域靠近组织的第二区域。
10.如权利要求1所述的内窥镜装置，其中所述第一或第二组织接近部件包括多个用来将第一区域紧固在组织的第二区域上的紧固件。
11.如权利要求10所述的内窥镜装置，其中所述紧固件选自卡钉、架子、螺钉、粘合剂、缝线及其组合。
12.一种用内窥镜靠近在中空身体器官内的组织的方法，它包括：
将细长体定位在一部分要从中空身体器官中切除的组织附近；
可释放地紧固位于圆周上围绕着第一组织接近部件的组织第一区域和位于圆周上围绕着第二组织接近部件的组织第二区域，将所要切除的组织设置在第一和第二组织接近部件之间；
从第一和第二组织接近部件之间除去所要切除的组织；
使第一和第二组织接近部件靠近，从而使组织的第一和第二区域彼此相邻；并且
将组织的第一区域紧固在组织的第二区域上。
13.如权利要求12所述的方法，其中通过真空力分别将组织的第一和第二区域可释放地紧固在第一和第二组织接近部件上。
14.如权利要求12所述的方法，其中通过多个紧固件分别将组织的第一和第二区域可释放地紧固在第一和第二组织接近部件上。
15.如权利要求14所述的方法，其中所述紧固件是可收缩的。
16.如权利要求12所述的方法，其中可释放地紧固包括使第一和第二组织接近部件径向膨胀成分别与组织的第一和第二区域接触。
17.如权利要求12所述的方法，其中除去所要切除的组织包括用腹腔镜的方式从第一和第二组织接近部件之间切除组织。
18.如权利要求12所述的方法，其中使第一和第二组织接近部件接近包括使第一和第二组织接近部件沿着细长体朝着彼此纵向移动。
19.如权利要求12所述的方法，其中将组织的第一区域紧固在组织的第二区域上包括通过第一或第二组织接近部件将第一区域钉在或缝合在第二区域上。
20.如权利要求12所述的方法，还包括径向减小第一和第二组织接近部件的直径。
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