CN101077312B - 内窥镜胃间隔术的方法和装置 - Google Patents

内窥镜胃间隔术的方法和装置 Download PDF

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CN101077312B
CN101077312B CN2007101055590A CN200710105559A CN101077312B CN 101077312 B CN101077312 B CN 101077312B CN 2007101055590 A CN2007101055590 A CN 2007101055590A CN 200710105559 A CN200710105559 A CN 200710105559A CN 101077312 B CN101077312 B CN 101077312B
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M·S·奥尔蒂斯
D·N·普莱斯西亚
T·A·迪特尔
S·H·埃克
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Abstract

本发明提供了用于连接组织的相对壁的内窥镜装置和方法。该方法和装置可以用于向相对的组织输送多个紧固件，并且延伸穿过紧固件的缝线可以用于将组织拉在一起。缝线可以预先编织穿过紧固件，由此允许快速且简单地展开。尽管这里公开的各种方法和装置可以用在各种手术中，但是在一些实施例中，该装置和方法可以用于将胃的相对的壁拉在一起，以在胃中形成胃囊，这降低了胃排空的速度。

Description

内窥镜胃间隔术的方法和装置
技术领域
本发明整体上涉及用于在内窥镜下进行胃间隔手术的外科方法和装置。
背景技术
病理性肥胖是一种严重的医学病症。事实上，病理性肥胖在美国以及其他国家已经变得非常普遍，其趋势看起来正向着消极方向发展。与病理性肥胖相关的并发症包括显著降低期望寿命的高血压、糖尿病、冠状动脉疾病、中风、充血性心力衰竭、多种整形外科问题以及肺动脉瓣闭锁不全。考虑到这些问题，本领域技术人员当然理解，与病理性肥胖有关的资金和物质花费是巨大的。实际上，据估计，仅仅在美国一个国家，涉及肥胖的花费超过1000亿美元。
已经开发了多种外科手术来治疗肥胖。目前最常进行的手术是鲁氏Y形(Roux-en-Y)胃旁路术(RYGB)。这种手术具有高度的复杂性，通常用于治疗呈现病理性肥胖的患者。其它形式的肥胖治疗手术包括Fobi袋(Fobi pouch)、胆-胰转流术以及胃成形术或者“胃间隔手术”。此外，限制食物经过胃的通道并影响饱胀感的可植入装置也是已知的。
RYGB包括使用鲁氏Y形环使空肠运动到较高的位置。使用自动吻合器将胃完全分为两个不相等的部分(较小的上部和较大的下部胃囊)。上部囊通常小于大约1盎司(或20cc)，而较大的下部囊则通常保持完整并继续隐藏流过肠道的胃液。
然后，从下腹引出小肠的一段并与上部囊相连以形成通过半英寸的开口产生的出口，也称作人造口。小肠的该段称作“鲁氏环”鲁氏袢，并将来自上部囊的食物输送到肠的剩余部分，食物在此处被消化。然后，通常使用吻合器设备将剩余的下部囊和十二指肠的附着段重新连接以在距离人造口大约50到150cm的位置处形成与鲁氏环袢相连的另一个吻合连接。在该位置处，来自胃旁路、胰腺和肝的胃液进入空肠和回肠以辅助食物的消化。由于上部囊的尺寸小，所以迫使患者以较慢的速度进食但是更快地吃饱。这导致热量摄取的减少。
传统的RYGB手术需要大量的手术时间。由于创伤程度，手术后的恢复时间可能非常长并且很痛苦。考虑到与目前RYGB手术相关的高创伤性，已经开发了其他的较小创伤性的手术。据此，已经开发了用于减小胃尺寸的其他手术。胃间隔外科的最常用方式包括沿着胃施加竖直的吻合器来产生合适的囊。该手术通常是在腹腔镜下进行的，并由此需要许多手术前、手术中、手术后的资源。
据此，需要允许以高效并且对患者友好的方式来进行胃间隔外科手术的过程。由此，本发明提供了用于进行胃间隔术的方法和装置。
发明内容
本发明整体上提供了用于在内窥镜下进行胃间隔术的方法和装置。在一个示例性实施例中，提供了内窥镜胃间隔装置，其具有：细长的端部执行器，该端部执行器具有纵向延伸穿过其中的第一槽和第二槽，所述第一槽和第二槽中适于收纳组织；和布置在所述端部执行器中的多个紧固件，所述多个紧固件能够自展开，以在所述紧固件从端部执行器释放时接合布置在所述槽中的组织。端部执行器可以具有各种构造，在一个实施例中，其由彼此可动地连接的多个节段形成，以在所述端部执行器穿过弯曲的内腔时允许其弯曲。该装置还可以包括缝线，所述缝线连接到所述多个紧固件并被预先编织，使得当所述紧固件从所述端部执行器释放以接合组织时，所述缝线将延伸穿过所述多个紧固件。每个紧固件也可以具有各种构造。例如，每个紧固件可以包括相对的腿部，当所述紧固件从所述端部执行器释放时，所述相对的腿部靠近在一起形成环形构件。
在另一个实施例中，提供了一种内窥镜胃间隔装置，其包括轴，轴的远端上具有端部执行器。所述端部执行器可以包括彼此可动地连接的多个节段。所述节段例如通过延伸穿过所述多个节段的至少一个细长的柔性构件彼此可移动地连接。端部执行器还可以包括至少一个槽，其形成于所述多个节段中并适于将组织收纳于其中。在一个示例性实施例中，所述端部执行器包括第一槽和第二槽，所述第一槽和第二槽形成于所述多个节段的相对侧中并沿着其延伸。该装置可以进一步包括至少一个紧固件保持构件，其延伸穿过所述多个节段，且适于保持至少一个组织紧固件并将所述至少一个组织紧固件输送到布置于所述至少一个槽中的组织。在一个示例性实施例中，装置包括：第一和第二紧固件保持构件，其在第一槽的相对侧上延伸穿过端部执行器；以及第三和第四紧固件保持构件，其在第二槽的相对侧上延伸穿过端部执行器。所述紧固件保持构件可以沿着所述端部执行器的轴线在第一位置和第二位置之间滑动，在所述第一位置处，所述紧固件保持构件将至少一个紧固件的相对的腿部保持在至少一个槽的相对侧上，在所述第二位置处，所述紧固件保持构件释放所述至少一个紧固件的所述相对的腿部。所述紧固件保持构件可以连接到至少一个致动器，所述致动器适于使所述紧固件保持构件在所述第一和第二位置之间移动。在一些示例性实施例中，所述致动器适于在热量施加至其时长度缩短，由此使所述紧固件保持构件在所述第一和第二位置之间滑动。
装置还可以包含其他特征，例如至少一个组织损伤元件，其布置于所述至少一个槽中并适于损伤位于其中的组织；光学图像聚集单元，其布置在所述端部执行器的一部分上用于观察所述端部执行器周围的手术部位；和/或形成于所述至少一个槽的多个抽吸端口，其用于将组织抽吸到所述槽中。在端部执行器包含多个抽吸端口的情况下，所述端部执行器可以可选地包括：第一抽吸管，其被构造成通过形成于第一槽中的多个抽吸端口来施加抽吸作用；和第二抽吸管，其被构造成通过形成于第二槽中的多个抽吸端口来施加抽吸作用，由此允许差压抽吸。在其他实施例中，端部执行器可以可移动地连接到所述轴。例如，四杆连接机构可以将所述端部执行器可移动地连接到所述轴。
该装置还可以包括多个紧固件，其保持在所述端部执行器中并延伸穿过所述槽用于接合位于所述槽中的组织。在一个示例性实施例中，所述紧固件可以由超弹性材料形成，并且所述多个紧固件被构造成在它们被所述至少一个紧固件保持构件释放时接合组织。至少一个缝线可以延伸穿过所述端部执行器并被构造成在多个紧固件展开到组织中时连接到所述多个紧固件。
本发明还提供了一种用于建立胃间隔的方法。在一个实施例中，该方法可以包括通过食道导入细长构件以将所述细长构件上的端部执行器定位在胃中。在所述端部执行器穿过食道时，所述端部执行器弯曲。该方法可以进一步包括将组织抽吸到形成于端部执行器中的槽中；将多个紧固件输送到布置于槽中的组织；以及拉紧连接到所述多个紧固件上的缝线。优选地，在输送所述紧固件之前，所述缝线被预先编织穿过所述紧固件。在一个示例性实施例中，所述端部执行器的尖端可以位于幽门中，以将端部执行器锚固在胃中。在另一个实施例中，在输送所述多个紧固件之后，可以对胃进行充气以使所述紧固件从所述端部执行器分离。
各种技术可以用于输送紧固件。例如，通过轴向滑动延伸穿过所述端部执行器的至少一个击发杆以释放所述多个紧固件，可以输送紧固件。在一个示例性实施例中，通过释放所述多个紧固件的第一腿部以使所述第一腿部穿入到布置于槽中的组织中，并释放所述多个紧固件的第二腿部以使所述第二腿部穿入组织中以与接合所述组织的第一腿部形成环形紧固件，可以输送紧固件。在其他实施例中，多个紧固件可以被同时输送。该方法还可以包括向形成于槽中的至少一个组织损伤元件施加能量来损伤所述槽中的组织。
本发明具体涉及：
(1)一种内窥镜胃间隔装置，包括：
细长的端部执行器，其具有第一槽和第二槽，所述第一槽和第二槽穿过所述端部执行器纵向延伸，所述第一槽和第二槽适于将组织收纳在其中；以及
布置在所述端部执行器中的多个紧固件，所述多个紧固件能够自展开，以在所述紧固件从所述端部执行器释放时接合布置在所述槽中的组织。
(2)根据第(1)项所述的装置，其中，所述端部执行器由彼此可动地连接的多个节段形成，以在所述端部执行器穿过弯曲的内腔时允许其弯曲。
(3)根据第(1)项所述的装置，其中，所述第一槽和第二槽中形成有多个抽吸端口，用于将组织抽吸到所述第一槽和第二槽中。
(4)根据第(1)项所述的装置，还包括缝线，所述缝线连接到所述多个紧固件并被预先编织，使得当所述紧固件从所述端部执行器释放以接合组织时，所述缝线延伸穿过所述多个紧固件。
(5)根据第(1)项所述的装置，其中，所述多个紧固件包括相对的腿部，当所述紧固件从所述端部执行器释放时，所述相对的腿部相互靠近形成环形构件。
(6)根据第(1)项所述的装置，还包括布置于所述槽中的至少一个组织损伤元件，其适于损伤位于其中的组织。
(7)一种用于处理第(1)项所述的装置用以进行外科手术的方法，包括：
a)获得第(1)项所述的装置；
b)对所述装置进行消毒；以及
c)将所述装置储存在消过毒的容器中。
(8)一种内窥镜胃间隔装置，包括：
轴，其远端上具有端部执行器，所述端部执行器包括：彼此可动地连接的多个节段；至少一个槽，其形成于所述多个节段中并适于将组织收纳于其中；以及至少一个紧固件保持构件，其延伸穿过所述多个节段，且适于保持至少一个组织紧固件并将所述至少一个组织紧固件输送到布置于所述至少一个槽中的组织上。
(9)根据第(8)项所述的装置，其中，所述多个节段通过延伸穿过所述多个节段的至少一个细长柔性构件彼此可动地连接。
(10)根据第(8)项所述的装置，其中，所述至少一个槽包括第一槽和第二槽，所述第一槽和第二槽形成于所述多个节段的相对侧中并沿着所述相对侧延伸。
(11)根据第(10)项所述的装置，其中，所述端部执行器包括：第一抽吸管，其被构造成通过形成于第一槽中的多个抽吸端口来进行抽吸；和第二抽吸管，其被构造成通过形成于第二槽中的多个抽吸端口来进行抽吸。
(12)根据第(10)项所述的装置，其中，所述至少一个紧固件保持构件包括：第一和第二紧固件保持构件，其在第一槽的相对侧上延伸穿过所述端部执行器；以及第三和第四紧固件保持构件，其在第二槽的相对侧上延伸穿过所述端部执行器。
(13)根据第(8)项所述的装置，其中，所述至少一个紧固件保持构件可以沿着所述端部执行器的轴线在第一位置和第二位置之间滑动，在所述第一位置处，所述至少一个紧固件保持构件将至少一个紧固件的相对的腿部保持在至少一个槽的相对侧上，在所述第二位置处，所述至少一个紧固件保持构件释放所述至少一个紧固件的所述相对的腿部。
(14)根据第(13)项所述的装置，其中，所述至少一个紧固件保持构件连接到至少一个致动器，所述致动器适于使所述至少一个紧固件保持构件在所述第一和第二位置之间移动。
(15)根据第(14)项所述的装置，其中，所述至少一个致动器适于在热量施加至其上时长度缩短，由此使所述至少一个紧固件保持构件在所述第一和第二位置之间滑动。
(16)根据第(8)项所述的装置，还包括至少一个组织损伤元件，其布置于所述至少一个槽中并适于损伤位于其中的组织。
(17)根据第(8)项所述的装置，还包括光学图像聚集单元，其布置在所述端部执行器的一部分上，用于观察所述端部执行器周围的手术部位。
(18)根据第(8)项所述的装置，还包括形成于所述至少一个槽中的多个抽吸端口，用于将组织抽吸到所述槽中。
(19)根据第(8)项所述的装置，其中，所述端部执行器可动地连接到所述轴上。
(20)根据第(19)项所述的装置，还包括四杆连接机构，其将所述端部执行器可动地连接到所述轴上。
(21)根据第(8)项所述的装置，还包括多个紧固件，其保持在所述端部执行器中并延伸跨过所述槽，用于接合位于所述槽中的组织。
(22)根据第(21)项所述的装置，其中，所述多个紧固件由超弹性材料形成，并且所述多个紧固件被构造成在它们被所述至少一个紧固件保持构件释放时接合组织。
(23)根据第(21)项所述的装置，还包括至少一根缝线，所述缝线延伸穿过所述端部执行器并被构造成在所述紧固件展开到组织中时连接到所述多个紧固件上。
(24)一种用于修复权利要求8所述装置的方法，包括：
移除并替换所述装置的至少一部分，以使所述装置准备用于再次使用。
(25)一种用于形成胃间隔的方法，包括：
通过食道导入细长构件，以将所述细长构件上的端部执行器定位在胃中，在所述端部执行器穿过食道时，所述端部执行器弯曲；
将组织抽吸到形成于端部执行器中的槽中；
将多个紧固件输送到布置于槽中的组织；
移除所述细长构件；以及
拉紧连接到所述多个紧固件上的缝线。
(26)根据第(25)项所述的方法，还包括：在输送所述多个紧固件之后，对胃进行充气以使所述紧固件从所述端部执行器分离。
(27)根据第(25)项所述的方法，其中，所述端部执行器的尖端定位在幽门中，以将端部执行器锚固在胃中。
(28)根据第(25)项所述的方法，其中，通过轴向滑动延伸穿过所述端部执行器的至少一个击发杆以释放所述多个紧固件，来输送所述多个紧固件。
(29)根据第(25)项所述的方法，其中，通过释放所述多个紧固件的第一腿部以使所述第一腿部穿入到布置于槽中的组织中，并释放所述多个紧固件的第二腿部以使所述第二腿部穿入组织中以与接合所述组织的第一腿部形成环形紧固件，来输送所述多个紧固件。
(30)根据第(25)项所述的方法，还包括向形成于槽中的至少一个组织损伤元件施加能量来损伤所述槽中的组织。
(31)根据第(25)项所述的方法，其中，所述多个紧固件被同时输送。
(32)根据第(25)项所述的方法，其中，在输送所述紧固件之前，所述缝线被预先编织穿过所述紧固件。
(33)根据第(25)项所述的方法，还包括在至少使用一次之后对所述装置进行消毒的步骤。
附图说明
结合附图，可以从以下的详细描述中更彻底地理解本发明，其中：
图1是内窥镜胃间隔装置的一个示例性实施例的立体图，其具有带有端部执行器的细长轴，所述端部执行器具有多个节段；
图2是图1所示端部执行器的一个节段的分解视图，示出了用于使所述多个节段柔性配合的构件；
图3是图1所示内窥镜胃间隔装置的一个节段的立体图，示出了端部执行器与装置的细长轴之间的关节连接；
图4是图1所示内窥镜胃间隔装置的端部执行器的所述多个节段中的一个的立体图；
图5是用于与图1的装置一起使用的紧固件的一个示例性实施例的侧视图；
图6是图1所示内窥镜胃间隔装置的端部执行器的一个节段的剖视图，示出了布置于其中的图5的紧固件；
图7是图1所示内窥镜胃间隔装置的端部执行器的一个节段的局分解视图，示出了用于从端部执行器释放多个紧固件的击发机构；
图8是图1所示内窥镜胃间隔装置的远侧立体视图，示出了布置于装置上以辅助装置定位的光学器件的一个实施例；
图9A是胃的局部剖视图，示出了布置于其中的图1的装置；
图9B图示了图9A的胃，其中装置已经移除，而留下多个紧固件布置于胃中并通过缝线来连接；和
图9C图示了图9B的胃，其中缝线被拉紧以连接到胃的相对的组织壁上。
具体实施方式
现在将描述一些示例性实施例，以为这里所公开结构的原理、功能、制造以及装置和方法的使用提供完全的理解。这些实施例的一些或多个示例图示在附图中。本领域技术人员应当理解，这里具体描述并图示在附图中的装置和方法是非限制性的示例性实施例，并且本发明的范围仅由权利要求来限定。结合一个示例性实施例图示或描述的特征可以与其他实施例的特征进行组合。这样的修改和变形都意图包含在本发明的范围内。
本发明整体上提供了用于连接组织的相对壁的内窥镜装置和方法。该方法和装置可以用于向相对的组织输送多个紧固件，并且延伸穿过紧固件的缝线可以用于将组织拉在一起。缝线可以预先编织穿过紧固件，由此可以快速且简单地展开。尽管这里所公开的方法和装置可以用在各种手术中，但是在一些示例性实施例中，该方法和装置被用于将胃的相对的壁拉在一起以在胃中形成胃囊，这降低了胃排空的速度。本领域技术人员应当理解，该方法和装置事实上可以被构造用于需要将两个组织表面彼此连接在一起的任何医疗处理。
图1图示了用于将相对的组织表面连接在一起的装置10的一个示例性实施例。如图所示，装置10通常包括细长轴12，细长轴12的远端12b上具有端部执行器14。端部执行器14中形成有相对的槽(图1中仅示出了一个槽16a)，该槽被构造成将组织的相对的壁抽吸并拉动到槽中。每个槽都被构造成向位于其中的组织输送多个紧固件。结果，端部执行器14可以输送多个紧固件到达组织的相对的壁。紧固件可以通过缝线来配合，使得缝线可以被拉紧以将组织的相对的壁拉在一起。在紧固件被输送到胃时，胃的相对壁的连接将形成胃囊，这限制了食物的通过。本领域技术人员应当理解，这里所公开的方法和装置不限于用在胃间隔术中，它们可以用在将组织永久或临时拉在一起的各种软组织并置处理中。
装置10的细长轴12可以具有各种构造，并且具体的构造可以根据装置的用途而改变。例如，装置可以被构造用于腹腔镜应用，因此轴基本上可以具有细长的刚性构造，这样允许轴插入穿过进入端口或其他端口。可替换地，细长轴12可以具有柔性的构造，这样允许轴12在内窥镜下使用并由此插入穿过身体内腔(例如食道或结肠)。轴12可以由各种材料形成并可以具有允许轴12弯曲的各种构造。
轴12还可以包括连接到其近端12a上的手柄30。手柄30可以辅助装置10的握持，并可以其还可以包括各种形成于其上的致动机构来辅助装置10的操作。如图1所示，手柄30包括：按钮32，按钮32被构造成在其被压下时从端部执行器14释放多个紧固件；滑杆34，其被构造成相对于手柄30移动以使端部执行器14相对于细长轴12进行关节运动，如下进一步详细所述。手柄30还可以包括形成于其近端中的开口，以允许各种装置插入穿过手柄30和细长轴12。本领域技术人员应当理解，根据装置10的构造，还可以使用其他的致动机构。
连接到轴12的远端12b或形成于其上的端部执行器14也可以具有各种构造，但是在一个示例性实施例中，端部执行器14大致具有细长的圆柱形构造，以使端部执行器14经腔插入穿过，也就是通过插入穿过身体内腔。端部执行器14或者至少其一部分还可以是柔性的以辅助插入穿过弯曲的身体内腔。尽管各种技术可以用于提供柔性的端部执行器14，但是在一个示例性实施例中，如图1所示，端部执行器14可以包括几个节段14a、14b、14c，这几个节段彼此可动地连接，以在端部执行器14经腔插入时，允许端部执行器14弯曲和旋转。尽管节段的具体数量可以根据各个节段的长度以及装置10的用于而改变，但是图1图示了彼此可动地连接的三个节段14a、14b、14c。每个节段14a、14b、14c的长度为50mm或更小，但是该长度可以根据应用而改变。端部执行器14还可以包括形成于其上或者连接于其上的远侧尖端或者端盖24，以辅助插入穿过身体内腔。如图1所示，端盖24大致具有锥形的构造，并连接到第三节段14c的最远侧的端部。
各种技术可以用于使节段14a、14b、14c彼此可移动地配合，但是在一个示例性实施例中，如图2详细地示出，节段14a、14b、14c可以通过一个或多个柔性的细长构件来连接。具体而言，图2图示了两个细长的柔性弹簧22a、22b，柔性弹簧22a、22b延伸通过穿过各个节段(图2仅图示了节段14a和14b)形成的纵向孔26a、26b。弹簧22a、22b在其最近侧的端部处连接到第一节段14a，并在其最远侧的端部处连接到最后的或第三节段14c。可替换地，弹簧22a、22b可以配合到图1所示的端盖24，而不是最后的或第三节段14c配合到端盖24。在使用中，节段14a、14b、14c相对于弹簧22a、22b自由滑动和弯曲，由此允许节段14a、14b、14c相对于彼此移动。尽管示出了弹簧，但是也可以使用柔性的轴、线缆或其他的柔性构件。此外，本领域技术人员应当理解，各种技术可以用于允许节段14a、14b、14c之间的相对运动。
返回参考图1，示出了端部执行器14，当节段14a、14b、14c处于静止状态时，端部执行器14具有大致线性的构造。在其他实施例中，当节段14a、14b、14c处于静止状态时，端部执行器14可以被构造成具有预定的非线性构造，例如S型或C型的构造。通过使节段14a、14b、14c中的一个或多个形成为具有弯曲的构造而不是线性构造，可以实现上述的构造。由此，当端部执行器14插入穿过弯曲的内腔时，节段14a、14b、14c可以相对于彼此移动，以允许端部执行器14穿过内腔。一旦将端部执行器14例如定位在病人的胃中，端部执行器将处于预定的非线性构造。这将允许以需要的模式或者构造来施加紧固件。
除了端部执行器14的节段14a、14b、14c可以相对于彼此移动之外，端部执行器14也可以相对于细长轴12移动。例如，在一个实施例中，端部执行器14可以被构造成相对于细长轴12的远端12b进行关节运动，以允许将端部执行器14定位为相对于细长轴12的轴线成一定角度。在另一个实施例中，端部执行器14可以被构造成从线性构造(其中端部执行器14与轴12的纵向轴线对齐并沿着其延伸)移动到偏移的位置(其中端部执行器14偏离于轴12的轴线定位，如图1所示)。在偏移的位置，端部执行器14的纵向轴线可以保持基本上平行于细长轴12的纵向轴线。这对于细长轴12被用于导入其他装置的情况特别有利。例如，细长轴12可以包括从其中延伸穿过的内腔，用于收纳内窥镜装置(例如内窥镜)。将端部执行器14定位为从轴12的远端12b偏移可以防止端部执行器14与内窥镜或其他装置的使用发生干涉。
尽管事实上本领域所公知的任何用于使端部执行器14相对于细长轴12进行枢转或进行关节运动的技术可以用于本发明，但是在一个示例性实施例中，端部执行器14可以使用四杆连接机构配合到细长轴12。这详细地图示在图3中，图3示出了在细长轴12的远端12b与第一节段14a的近端之间延伸的第一和第二连杆28a、28b。连杆28a、28b彼此间隔开一定距离配合到轴12和节段14a，使得施加到致动器(未示出)(例如线缆或其他机构，其延伸穿过细长轴12并连接到端部执行器14)上的指向近侧的张力向近侧拉端部执行器14，由此将端部执行器14移动到细长轴12的一侧。连杆28a、28b还可以由形状记忆材料或其他弹簧材料形成，使得致动器的释放可以允许连杆28a、28b向端部执行器14施加力，以将端部执行器14移动成初始的线性构造。可替换地，致动器可以被构造成在初始和偏移位置之间移动端部执行器14。
如前所述，端部执行器14被构造成将组织收纳在形成于其中的相对的槽中，并将一个或多个紧固件输送到组织中以允许组织的两个表面进行配合。每个节段14a、14b、14c可以具有各种构造以允许组织被收纳于其中并将一个或多个紧固件输送到组织。但是，图4图示了一个节段(例如节段14a)的一个示例性实施例。尽管仅讨论了节段14a，但是本领域技术人员应当理解，各个其他的节段(例如节段14b和14c)每个都可以具有相同的构造。
如图4所示，节段14a具有大致细长的构造，其具有通过横向的中间部分20来连接的相对的半圆柱形侧壁18a、18b，使得侧壁和中间部分20在节段14a中限定了相对的上部和下部槽16a、16b。槽16a、16b沿着节段14a的长度纵向延伸(也就是在节段的近端和远端之间)，使得当节段14a、14b、14c配合时，端部执行器14包括形成于其第一侧中的第一或上部细长槽以及形成于其第二(相对)侧中的第二或下部细长槽。这将允许通过端部执行器14来接合组织的相对壁，如下进一步的详细描述。各个槽16a、16b的具体宽度、深度和形状可以改变，但是每个槽16a、16b的尺寸优选允许组织被收纳于其中并通过容纳在端部执行器14中的紧固件来接合，如下所述。在图示的实施例中，每个槽16a、16b具有大致正方形或举行的横截面形状。
为了将组织定位在各个槽16a、16b中，槽16a、16b中可以形成一个或多个抽吸端口，抽吸端口被构造成将组织抽吸到槽16a、16b中。如图4所示，中间部分20包括上部和下部构件20a、20b，上部和下部构件20a、20b每个中形成有多个抽吸端口36。上部和下部构件20a、20b彼此间隔开一定距离以限定腔，该腔可以收纳它们之间的抽吸力以将组织抽吸到槽16a、16b中，如下所述。上部和下部构件20a、20b还可以通过间隔物彼此分离开，以允许仅选择性地向上部和下部槽16a、16b中的一个施加抽吸作用。在这种情况下，单独的抽吸管路可以延伸穿过端部执行器14用于选择性地将组织抽吸到上部和/或下部槽16a、16b中。在待彼此连接的组织表面彼此间隔开一定距离的情况下，这样特别有用。端部执行器14可以靠近第一组织表面定位，并且可以向第一槽16a施加抽吸作用以将第一组织表面拉到槽16a中。然后，在第一组织表面保持于其中的状态下，端部执行器14可以朝向第二组织表面移动，并且可以向第二槽16b施加抽吸作用以将第二组织表面拉到槽16b中。尽管未示出，但是槽16a、16b可以包括在各个其他位置处形成的抽吸端口，例如在节段14a的相对的侧壁18a、18b的内表面上。
为了在端部执行器14中产生抽吸作用，装置10可以包括延伸穿过细长轴12并连接到第一节段14a的近端上的抽吸管路38，如图3所示。抽吸管路38可以终止于端部执行器14的近端处，并且其可以被构造成通过端部执行器14的整个长度来产生抽吸力。可替换地，抽吸管路38可以在各个节段14a、14b、14c的上部和下部构件之间延伸，使得抽吸管路38延伸穿过端部执行器14的长度。抽吸管路38中可以形成有多个开口，用于沿着端部执行器14的长度产生抽吸力。本领域技术人员应当理解，各种其他技术可以用于产生抽吸作用，以将组织拉入到端部执行器14中的槽中。
继续参考图4，节段14a还可以可选地包括布置于槽16a、16b中的组织损伤元件，其被构造成有意地损伤组织，以促进组织并置之后的康复。尽管可以使用各种组织损伤技术，但是在一个示例性实施例中，组织损伤元件可以是电气元件的形式(例如用于向组织输送RF、单电极或双电极或其他能量的电极)或机械元件的形式(诸如位于槽16a、16b的侧壁或背壁上的刮刀或小的刀刃，它们移动从而切割组织)。在一个示例性实施例中，组织损伤元件是两个双极或单极带的形式，它们布置在各个槽16a、16b的相对侧壁18a、18b的内表面上。图4图示了布置于沿着节段14a的第一侧壁的长度延伸的内表面上的组织损伤带40。可替换地，各个侧壁18a、18b的一部分可以由导电材料形成用于收纳能量。组织损伤元件在侧壁18a、18b上的位置允许施加的能量穿过槽16a、16b的壁或者在槽16a、16b的壁之间。但是，组织损伤元件可以位于各个其他位置处，例如在中间构件20上或者在特定的区域中。在使用中，能量可以通过使用例如延伸穿过细长轴12的一个或多个引线输送到组织损伤元件。各个引线的近端可以连接到内部或外部能量源。
如前所述，一旦组织被抽吸到槽16a、16b中，装置10被构造成将一个或多个紧固件输送到组织。用于输送紧固件的具体技术可以根据紧固件的构造而变化，但是在一个示例性实施例中，紧固件能够自展开。图5图示了示作处于闭合或展开构造的一个示例性的自展开式紧固件42。如图所示，紧固件42包括相对的终端42a、42b，终端42a、42b被构造成穿透组织，并且在闭合的位置处终端形成圆形或环形的构件。各个端部42a、42b可以具有突出的或者锐利的尖端以帮助穿透组织。为了允许紧固件42能够自展开，例如通过用超弹性材料或形状记忆材料形成紧固件42，紧固件42可以被压到闭合的位置。在使用中，相对的端部42a、42b可以被拉开，以将紧固件42移动到打开的位置，并且在相对的端部42a、42b的释放时，端部42a、42b将自动朝向彼此移动，以穿透位于槽中的组织。
各种技术可以用于将一个或多个紧固件42保持在端部执行器14中，但是在一个示例性实施例中，每个节段中形成有至少一个并且优选是多个紧固件保持切口。例如，图4图示了其中形成的三个紧固件保持切口44a、44b、44c，使得第一节段14a将三个紧固件输送到布置于上部槽16a中的组织。尽管未示出，相对的下部槽16b类似地包含形成于其中的三个紧固件保持切口，用于将三个紧固件输送到相对的槽16b中的组织。切口44a、44b、44c的尺寸被调整为允许紧固件42的端部42a、42b保持在其中，并被选择性地释放以展开到组织中。图6图示了紧固件42，紧固件42的相对的端部42a、42b被彼此拉开并且位于第一节段14a中形成的一个切口(例如切口44a)中。紧固件42的中间部分被示出延伸穿过槽16a，使得在组织被抽吸到槽16a中时，组织将位于紧固件42的端部42a、42b之间。
为了将紧固件42的相对的端部42a、42b保持在切口44a中，装置10可以包括一个或多个击发杆，击发杆延伸穿过各个节段14a、14b、14c并适于保持且从端部执行器14选择性地释放紧固件。尽管击发杆可以具有各种构造，但是在一个示例性实施例中，各个节段14a、14b、14c包括：第一击发杆，其位于第一侧壁中用于保持布置于上部和下部槽中的各个紧固件的第一端；和第二击发杆，其位于第二侧壁中用于保持布置于上部和下部槽中的各个紧固件的第二端。例如，这图示在图6中，图6示出了布置于第一节段14a的第二侧壁18b中的击发杆48。击发杆48将保持布置于上部槽16a中的各个紧固件42的第二端42b和布置于下部槽16b中的各个紧固件42的第二端42b。另一个击发杆(未示出)布置于第一侧壁18a中，并且其保持布置于上部槽16a的各个紧固件42的第一端42a和布置于下部槽16b的各个紧固件42的第一端42a。
为了将各个紧固件42的端部42a、42b保持在切口44a、44b、44c中，各个击发杆中可以形成多个紧固件保持腿部。图7图示了布置于第一节段14a的第一侧壁18a中的击发杆46，其中形成有六个腿部46a、46b、46c、46d、46e、46f。击发杆46大致具有细长的平面构造，三个腿部46a、46b、46c从其第一侧向形成于上部槽16a中的切口(三个切口仅示出了两个，示作44a、44b)延伸，另外三个腿部46d、46e、46f从其相对侧向形成于下部槽16b中的切口44a’、44b’、44c’延伸。腿部46a-f中的每个包括勾形的终端，其被构造成接合紧固件42的终端42a、42b中的一个，以将该端部保持在切口中。各个腿部46a-46f的勾形终端还在相同的方向上延伸，使得击发杆46相对于节段14a的运动将同时释放由击发杆46所接合的所有紧固件的终端。因为节段14a包括两个击发杆46、48，击发杆46、48可以被分别致动以在释放各个紧固件42的另一个端部(例如第二端42b)之前释放各个紧固件42的一个端部(例如第一端42a)。这是特别有利的，因为其可以辅助组织穿透。具体而言，在一次仅释放紧固件的一个端部的情况下，槽中的组织将夹在紧固件的腿部与槽的相对壁之间，由此增强了穿透性。
如上所述，紧固件的端部可以通过在节段14a中移动击发杆46、48来释放。在一个示例性实施例中，击发杆46、48适于沿着节段14a的轴线在近侧位置和远侧位置之间滑动，以在接合的位置(其中紧固件保持在端部执行器14中)与分离的位置(其中紧固件的端部被释放并且能够自由闭合以穿过布置在槽16a、16b中的组织)之间移动。各种技术可以滑动击发杆46、48。例如，装置10可以包括延伸穿过其的一个和多个细长的致动器杆，该致动器杆连接到击发杆46、48用于使击发杆在近侧位置和远侧位置之间移动。在另一个实施例中，能量(例如热)可以输送到连接至击发杆上的形状记忆合金(SMA)导线，以使导线收缩并由此将击发杆从近侧位置推动到远侧位置，以释放紧固件。例如，第一和第二导线可以延伸穿过弹簧22a、22b或者连接节段14a、14b、14c的其他柔性构件。第一导线可以在各个节段14a、14b、14c中移动第一击发杆，第二导线可以在各个节段14a、14b、14c中移动第二击发杆。图7图示了延伸穿过第一节段14a的第一弹簧22a、和位于其中部并固定地配合到延伸穿过弹簧22的导线(未示出)上的连接器52。翼片52延伸到形成于击发杆46中的开口中，使得翼片52在近侧位置和远侧位置之间的运动将使击发杆46移动。为了移动击发杆，能量可以经由延伸穿过细长轴12并连接到导线上的引线选择性地输送到各个导线，以引起导线收缩。如前所述，装置10的手柄30例如可以包含按钮32，按钮32被构造成在压下时致动布置于手柄中或连接到手柄上的能量源并由此输送能量到导线以移动击发杆。尽管未示出，手柄30可以可选地包括两个单独的按钮，用于输送能量到两个单独的导线，用于单独移动各个节段中的第一击发杆和各个节段中的第二击发杆。这将允许位于端部执行器的上部和下部槽中的各个紧固件的第一端可以被同时释放，并且在同时释放位于上部和下部槽中的各个紧固件的第二端之前释放第一端。本领域技术人员应当理解，各种其他技术可以用于移动击发杆。
尽管未示出，装置10还可以包括延伸穿过其的一个或多个缝线，缝线定位为使得在紧固件展开到位于各个槽中的组织中时延伸穿过各个紧固件。在一个示例性实施例中，单根缝线延伸穿过装置的细长轴12，穿过各个紧固件的端部之间的第一槽，穿过各个紧固件的端部之间的第二槽，并通过细长轴12退回。结果，当所有紧固件被释放时，缝线将延伸穿过各个紧固件，并且缝线的自由端将保持在患者身体之外。这将允许移除装置，并且张紧缝线以配合相对的组织表面。
装置10还可以包括本领域公知的各种其他特征。例如，各种组织胶粘物可以用于辅助相对的组织壁的配合，并将组织密封在一起。通过非限制性的示例，纤维基的组织胶粘物可以布置在各个节段的中间部分的上部和下部构件上，以接触被吸入上部和下部槽中的组织。该胶粘物减少了紧固件并置组织上的负荷并增加了有效的保持期。
在另一个实施例中，装置10可以包括布置于其上的光学图像聚集单元，其被构造成在内窥镜手术过程中获取图像。尽管单元的位置可以改变，但是在一个实施例中，光学图像聚集单元可以布置在端盖24上，如图8所示。具体而言，图8图示了从端盖24的外表面突出的壳体54，壳体54中容纳光学图像聚集单元。观察窗口56形成于壳体54的面向远侧的表面上，以允许单元获取端部执行器14以及周围的手术部位处的图像。来自光学图像聚集单元的图像可以被传输到外部的图像显示屏，或者可替换地，装置10可以包括布置于装置近侧部分上或者连接至其的图像显示屏。
图9A-9C图示了使用胃间隔术将相对的组织表面彼此连接的一个示例性方法，并且该方法特别用于建立胃间隔。该方法是结合图1的装置10进行描述的，但是，可以使用各种其他装置。如图9A所示，装置10通过食道经腔导入，以将其上的端部执行器14定位在胃中。装置10可以沿着预先定位在胃中的引导线来输送，和/或其可以在延伸穿过装置的细长轴12的帮助下来输送。例如，内窥镜上的导引机构可以用于导引装置穿过身体内腔。一旦端部执行器14位于胃中，通过抵靠胃的较小的曲线来定位端部24，装置10的远端可以可选地锚固在幽门阀中。这将帮助将装置10保持在合适的位置用于进行胃间隔术。端部执行器14还可以相对于细长轴12进行关节运动，以将端部执行器14定位为从细长轴12偏移。这可以通过在手柄30上滑动杆34以拉动连接到端部执行器14上的致动器线缆并由此枢转端部执行器14来实现。
一旦装置10处于需要的位置，抽吸作用可以施加到一个或两个槽以将组织拉到槽中。施加到一个槽(例如上部槽)上的抽吸作用将胃的前侧上的组织拉到槽中，而施加到另一个槽(例如下部槽)上的抽吸作用将胃的后侧上的组织拉到槽中。抽吸作用优选至少保持到紧固件被输送。
一旦两个组织表面被拉入到槽中，可选地，组织可以被损伤，并且紧固件可以在组织损伤之前或者之后来输送。通过致动手柄上用于致动能量源的按钮或旋钮(未示出)来输送能量到组织损伤元件，可以实现组织损伤，并且通过致动手柄30上的一个或多个按钮(例如按钮32)，可以输送紧固件。如下所述，在一个示例性实施例中，第一按钮被致动以移动位于上部槽和下部槽中每个的第一例上的击发杆。当能量被输送到第一导线时，导线将移动击发杆以释放容纳在端部执行器中的各个紧固件的第一端。释放的端部将穿透布置在槽中的组织，并且它们可能延伸穿过槽以与第二端叠置，并由此形成与布置于槽中的组织进行接合的环形紧固件。然后，第二按钮可以被致动以移动位于上部槽和下部槽中每个的第二侧上的击发杆。当能量被输送到第二导线时，导线将移动击发杆以释放容纳在端部执行器中的各个紧固件的第二端，由此从槽释放紧固件。抽吸作用可以被终止以释放紧固件布置于其中的组织。
一旦紧固件展开到胃的前壁和后壁，抽吸作用将被移除并用注气法来替代。这推动胃壁分开，这可以帮助将紧固件拉出端部执行器中它们各自的切口。然后，端部执行器可以从胃腔拔出。剩余的是延伸胃的前壁和后壁紧固的一系列紧固件以及延伸穿过各个紧固件的预穿的缝线。如图9B所示，紧固件可以被输送以形成缝合样式，例如褥式缝合，它们从胃的近端延伸到远端。也可以使用其他的缝合样式，包括线性的缝合样式。为了使胃的前壁和后壁到一起，张力可以施加到缝线的自由端以拉紧缝线，如图9C所示。自由端可以打结或者以其他方式彼此配合以将缝线保持在拉紧的状态。例如，安装到内窥镜上或者穿过内窥镜定位的打结元件可以用于打结并切断自由端。形成的胃的结构是小的管状囊的形式。囊可以在食道与幽门之间的整个长度上延伸或者也可以仅在从食道到幽门的距离的一部分上延伸。无论针脚的长度如何，残胃允许胃酸进入食物流，同时小的胃囊产生了减小的通道，其限制了穿过其的食物。
这里公开的各种装置(包括其部分)可以被设计为一次性使用，或者可以被设计为多次使用。但是，在任何情况下，在至少使用一次装置之后可以修复该装置。修复可以包括以下步骤的任何组合：拆卸装置；之后清洁或者替换具体的零件；并且之后重新组装。通过示例，在图1的装置已经用于医疗处理之后，该装置可以被修复。装置可以被拆卸，并且任意数量的具体零件(例如紧固件、缝线、端部执行器以及组织损伤元件)可以以任意组合被选择性地替换或者移除。例如，通过向端部执行器添加新的紧固件盒或者通过替换端部执行器，可以替换紧固件和缝线。通过具体部件的清洁和/和替换，在修复设备处或者通过紧接在外科手术之前的外科小组，装置可以被重新组装用于以后的使用。本领域技术人员应当理解，装置的修复可以使用各种技术来拆卸、清洁/替换以及再组装。这些技术的使用以及形成的修复的装置都在本申请的范围内。
基于上述的实施例，本领域技术人员应当理解本发明进一步的特征和优点。由此，本发明不由具体示出和描述的内容来限制，除非权利要求中示出。这里引用的公开出版物和参考文献都整体通过引用并入本文。

Claims (6)

1.一种内窥镜胃间隔装置，包括：
细长的端部执行器，其具有第一槽和第二槽，所述第一槽和第二槽穿过所述端部执行器纵向延伸，所述第一槽和第二槽能够将组织收纳在其中；
布置在所述端部执行器中的第一组多个紧固件，所述第一组多个紧固件能够自展开，以在从所述端部执行器释放时接合布置在所述第一槽中的组织；
布置在所述端部执行器中的第二组多个紧固件，所述第二组多个紧固件能够自展开，以在从所述端部执行器释放时接合布置在所述第二槽中的组织；以及
缝线，所述缝线连接到所述紧固件并被预先编织，使得当所述紧固件从所述端部执行器释放以接合组织时，所述缝线延伸穿过所述第一组多个紧固件和所述第二组多个紧固件。
2.根据权利要求1所述的装置，其中，所述端部执行器由彼此可动地连接的多个节段形成，以在所述端部执行器穿过弯曲的内腔时允许其弯曲。
3.根据权利要求1所述的装置，其中，所述第一槽和第二槽中形成有多个抽吸端口，用于将组织抽吸到所述第一槽和第二槽中。
4.根据权利要求1所述的装置，其中，所述紧固件包括相对的腿部，当所述紧固件从所述端部执行器释放时，所述相对的腿部相互靠近形成环形构件。
5.根据权利要求1所述的装置，还包括布置于所述第一槽或第二槽中的至少一个组织损伤元件，其能够损伤位于其中的组织。
6.一种用于处理权利要求1所述的装置用以进行外科手术的方法，包括：
a)获得权利要求1所述的装置；
b)对所述装置进行消毒；以及
c)将所述装置储存在消过毒的容器中。
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EP1859745B1 (en) 2010-11-17
BRPI0704539B8 (pt) 2021-06-22
MX2007006295A (es) 2009-02-17
BRPI0704539B1 (pt) 2019-01-22
JP5172209B2 (ja) 2013-03-27
AU2007202339B2 (en) 2012-08-23
EP1859745A1 (en) 2007-11-28
DE602007010531D1 (de) 2010-12-30
HK1113299A1 (en) 2008-10-03
AU2007202339A1 (en) 2007-12-13
ATE488184T1 (de) 2010-12-15
JP2007325922A (ja) 2007-12-20
CN101077312A (zh) 2007-11-28
CA2589880C (en) 2015-02-10
US20070276409A1 (en) 2007-11-29
BRPI0704539A (pt) 2008-05-13
CA2589880A1 (en) 2007-11-25

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