CN103841930B - 单步盲肠造瘘术 - Google Patents
单步盲肠造瘘术 Download PDFInfo
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Abstract
本发明描述了一种盲肠造瘘管(30),其具有头部(36),所述头部具有开口(42)和阀。其具有柔性导管(34),其具有管腔(38),所述导管具有近端和远端,所述导管的近端与头部中的开口流体连通,导管的一部分离开头部延伸以限定远端。具有固定器(32),其设置在导管的远端上。所述固定器能够例如响应于接触流体而从第一轮廓或配置改变形状至第二轮廓,其中所述第二轮廓大于所述第一轮廓,并且第二轮廓适于将盲肠造瘘管保持在体内就位。该装置可以包括第二管腔,粘合剂能够通过所述第二管腔注入并沿导管的外表面输送。该装置可通过单个初始手术操作来放置。
Description
技术领域
本发明涉及一种用于执行盲肠造瘘术的装置和方法。
背景技术
盲肠造瘘术是将导管置于患者的盲肠中。盲肠是大肠的一部分并位于紧挨小肠的后方。患有排便失禁的患者可以使用盲肠造瘘管来给予灌肠剂以从大肠上部至直肠快速且完全地排空大肠。输送灌肠剂(顺行)的方法相比逆行灌肠剂更加有效,这是因为实施逆行灌肠剂通常伴有大量泄漏。盲肠造瘘术明显地改进了那些遭受长期排便失禁的人们的生活质量。
排便失禁可能与蠕动、感觉、括约肌控制、解剖或心理问题的紊乱有关。在这些病因中有脊髓脊膜突出、泄殖腔畸形、尾退化综合症、截瘫、瘫痪、脑瘫、以及肠道蠕动的紊乱。通常的治疗方法包括饮食调整、轻泻剂、栓剂、灌肠剂、手动去除阻塞、生物反馈和电刺激。尽管做出这些努力,许多患者仍不能实现排便节制并继续会发生肠意外。严重的排便失禁,特别是在儿童中,可能导致严重的便秘以及流体从肛门的泄露,这对于儿童来说是一种难堪的事。
手术创建的盲肠造瘘术具有口狭窄(10-33%)、口泄露、阑尾坏死、全身麻醉、和肠穿孔的风险,但仍然证实是针对许多患者的合适的解决方案。
当前执行盲肠造瘘术的方法是两步处理法。该程序需要通过空气膨胀结肠直至盲肠扩大。小针穿过皮肤插入盲肠,然后外科医生将盲肠通过缝线附接至腹壁。导管然后在针的位置螺旋进入盲肠。为了确认导管的准确定位,通常经由导管注射对比染料,其使用荧光透视法来确保染料进入盲肠。该初始的盲肠造瘘术需要约6周愈合来形成稳定的瘘口。一旦确定了瘘口已经完全地愈合,在该初始布置后跟随最终盲肠造瘘导管的定位。
一个最近现有技术的盲肠造瘘导管,如图1所示,具有下部轮廓“活盖”凸缘接头2,其被设计为在不使用时平坦地抵靠皮肤,用于增强的患者依从性。该装置在Dr.Peter Chait的美国专利6,223,070中详细描述。Dr.Chait的装置不使用单独保持件,而是具有螺旋线圈4,其在用于将其插入的加劲杆(未示出)移除后在肠腔内再成形。线圈4用作将活盖凸缘2保持抵靠患者皮肤6并防止导管简单地滑出瘘口的保持机构。由于具有多个线圈,它可以调节以改变从皮肤6至内部肠腔8的距离。
Chait TrapdoorTM盲肠造瘘导管如上所述创建经由现有的拟定管道经皮穿刺插入。一旦移除最初的导管(导丝上),则将金属加劲杆插入ChaitTrapdoorTM盲肠造瘘导管中以弄直线圈并辅助推进导管随预先定位的导丝穿过该管道。一旦插入了盲肠造瘘导管,则移除加劲杆直至TrapdoorTM凸缘与入口部位的皮肤齐平。在移除加劲杆和导丝时,额外的导管线圈将在盲肠内再成形,从而将盲肠造瘘导管保持就位。
虽然现有技术的程序已经帮助许多患者应对排便失禁以引向更正常的生活,但针对两个单独手术的需求产生了感染和其他并发症的两种潜在事故。另外,螺旋线圈会在一段时间后被堵塞,从而盲肠造瘘导管必须时不时地更换。最后,Chait导管在导管不使用时会时而泄露。
需要的是一种用于给予顺行灌肠剂的装置,其可通过单个步骤插入盲肠内,而不需要初步和第二步手术操作。该装置还应该操作简单,且有效地允许患者控制有关灌肠剂施加的状况。该装置应该不需要由于堵塞而经常替换并且应当在不使用时最小化身体外部的泄漏。
发明内容
本发明描述了一种用于给予顺行灌肠剂的装置,其可在外科手术中安装。该装置通过允许布置在单个初始外科手术中来满足上述的要求。该装置具有不同于Chait装置的保持系统,其使得管较少可能地堵塞。该装置具有阀,期望的是单向阀,从而在该装置不使用时减少或消除身体外部的泄露。
该装置是具有头部的盲肠造瘘管,所述头部具有阀从中穿过的开口。具有柔性导管,其具有管腔并具有近端和远端,所述导管的近端与头部的开口流体连通,导管的一部分离开头部延伸以限定远端。导管还具有壁部,其从头部中限定的开口至导管的远端限定内表面和外表面。
在导管的远端上设置固定器。所述固定器能够从第一轮廓或配置至第二轮廓改变形状,其中所述第二轮廓大于所述第一轮廓,并且第二轮廓适于将盲肠造瘘管保持在体内。在所示第一、压紧轮廓,固定器可以更容易地穿过瘘口插入并进入盲肠。一旦进入盲肠,固定器轮廓会通过多种不同手段从第一轮廓变为第二轮廓:通过溶解或移除将固定器保持于压紧状态的涂层或包层;通过对球囊充气或通过展开伞状结构。
盲肠造瘘管可以具有第二管腔,其适于将流体从头部输送至导管外表面。所述流体可以是输送至导管外表面的粘合剂,从而帮助将盲肠结合至内腹壁以帮助产生稳定的瘘口。粘合剂,如果使用的话,应该是单体,其在诸如水或蛋白质分子的极性种属存在时聚合。以该方式将盲肠粘结至腹壁避免了将这两者缝合在一起的需求,但在需要时仍会用到缝线。
所述阀可期望的是单向阀,诸如挡板阀或鸭嘴阀。
本文还提供了一种执行盲肠造瘘术的方法。该方法具有如下步骤:将盲肠移动至靠近腹壁内表面的位置,创建从体腔外侧、穿过腹壁并进入盲肠的瘘口,经由瘘口插入具有保持器的盲肠造瘘管的远端,然后在保持器处于盲肠中后将盲肠造瘘管远端上的保持器的轮廓改变至第二、更大的配置。该盲肠造瘘管可通过单个初始的手术操作来安装。
该方法还可包括从盲肠造瘘管的第二管腔将粘合剂注射在所述盲肠和腹部之间的步骤。
本发明的其他目的、优势和应用将通过本发明优选实施方式的后面详细描述以及附图而变得清楚,其中相同参考标记指代相似或等效结构。
附图说明
图1是穿过皮肤插入肠腔安装的现有技术的装置、Chait TrapdoorTM盲肠造瘘导管的视图,并且其可用于通过皮肤表面上的“活盖”(图的最左侧)给予灌肠剂至盲肠。
图2A、2B和2C示出了盲肠运动并附接至腹壁的一连串视图。
图3是可与所公开的盲肠造瘘管一起使用的剥离扩张器的附图。
图4是可与所公开的盲肠造瘘管一起使用的剥离扩张器的另一附图。
图5A是盲肠造瘘管的附图,其示出了设计为保持在体外的头部、设计为帮助保持管就位的固定器、以及连接头部和固定器的轴杆或导管。在图5A中,固定器处于展开配置。在图5B中,固定器处于压缩配置。
图6A和6B示出了用于固定器的具有伞状设计的盲肠造瘘管。
图7是具有可膨胀球囊作为固定器的盲肠造瘘管的附图,其中所述盲肠造瘘管在球囊处于非充气状态时插入并且随后充气以帮助保持导管就位。
具体实施方式
现在将参照附图,其中本发明的各个元件将给出数字指示,并且其中将论述本发明以使得本领域技术人员能够做出和使用本发明。应该理解的是,下面描述仅是本发明原理的示例,并且不应该视为限制未决权利要求。本领域技术人员应该理解的是,所讨论的各个实施方式的各方面可以在不偏离本发明范围和精神的情况下互换和变化。
盲肠在下部肠道的最顶端部,紧邻小肠下游定位。盲肠造瘘术提供从体外至盲肠的入口。盲肠造瘘术允许给予顺行灌肠剂至那些遭受排便失禁的人们,改善他们的生活质量以及允许他们更容易控制这些重要身体功能。该问题影响了许多人,包括那些受脊柱裂折磨的人们,以及日益增加地,那些在所谓“极限运动”中受伤的人们。
为了安装盲肠造瘘管,需要使得盲肠20紧密靠近内腹壁22。图2A、2B和2C示出了盲肠20的运动以及附接至腹壁22的一系列视图。这可以首先通过使用穿过直肠插入的导管来对盲肠充气。一旦盲肠扩大,它在需要时可以通过盲肠中球囊的充气来保持在该状态。当盲肠紧靠腹壁时,使用针21穿过腹壁做出初次穿刺以产生瘘口。导丝可在需要时安装,但并非必须。所公开盲肠造瘘管的远端穿过皮肤插入并进入盲肠中。如果使用导丝的话,它可以沿导丝插入。如将在下文更加详细描述的,可在盲肠20和腹壁22之间注入胶水25以将盲肠20保持在该位置。
在可替代程序中,腹部可利用针穿刺,并且J形钩23可穿过腹部插入并用于部分地卷绕且勾住盲肠20(图2C)。然后可通过朝向腹壁移动钩来朝向腹壁22牵引盲肠29。可插入针来从腹壁外侧初次穿刺盲肠以产生瘘口。
在将盲肠造瘘管插入瘘口之前,可使用扩张器或一系列的传统扩张器来根据外科医生需要扩大瘘口。可替代地,可使用“剥离”扩张器24。如图3和4所示,该扩张器在两半26、28之间围绕固定器32和盲肠造瘘管(不可见)的远侧部。扩张器24通过内侧的盲肠造瘘管插入瘘口,并且一旦该管处于期望位置,扩张器可如图中箭头方向所示被剥离。剥离扩张器护套分离并从瘘口道以及远侧的固定器移除,盲肠造瘘管的留置端展开。
转向图5B,可以看出的是所公开盲肠造瘘管30的远端被设计为具有小轮廓用于穿过腹壁插入盲肠。图5B是盲肠造瘘管30远端的图,其示出了插入前在轴杆34远端上的固定器32。在一个实施方式中,固定器32以涂层包覆,所述涂层封装固定器32并将固定器32保持在围绕轴杆34的小的、紧密缠绕的、压紧的或折叠的第一轮廓或配置。为了安装管30,固定器32和轴杆34插入在腹壁和盲肠中做出的瘘口中,如上所述。一旦管就位,负载固定器32的轴杆34的远端处于盲肠中,则固定器32上的涂层溶解,使得管30的轴杆34远端上的固定器32扩张至第二轮廓或配置,如图3A所示。管30远端上的固定器32的扩张用作用于管30的锚,并将管30保持定位在盲肠中。
可以使用的涂层是一种将在体内溶解并无害地吸收或处理的涂层。类似于用于给药的凝胶胶囊的涂层或外壳已经证实能够良好工作。在一个实施方式中,固定器折叠在一起以使得它非常紧凑且小,并随后插入预成形的凝胶胶囊中。胶囊将固定器保持在该压紧、折叠配置直至管插入体内,由此接触体液,引起凝胶溶解并使得固定器展开至其完全展开状态。可替代地,如果仅接触体液不足够快速时,可以在轴杆管腔内注入盐或其他溶液进入盲肠中以帮助溶解固定器的凝胶涂层。快速的空气注入也可以明智地用于驱使凝胶胶囊脱离压紧的固定器。
还可以将胶囊形成在预压紧的固定器上就位。在该情形中,固定器可折叠在一起并通过机械部件保持在压紧配置。凝胶成分可以喷射、滴落或另外地涂覆在压紧的固定器上,并使得凝固。用于将固定器保持在压紧配置的机械部件可以小心地移除,使得凝胶将固定器保持在压紧配置直至它插入体内。
可以使用针对固定器的可替代配置。例如,可使用如图6A和6B所示的伞状展开的锚50。固定器可在下述之间交替:(a)第一长度的插入/移除状态或配置,使得固定器的支柱和/或其他元件与导管的外表面基本轴向对齐,从而给出与导管基本相同的有效截面面积;以及(b)第二长度的展开状态,所述第二长度比第一长度短,其中固定器的支柱和/或其他元件具有展开的有效截面面积,其直径显著大于导管的直径。固定器的一个实施方式可包括具有两个相对端部的套筒,并可包括塑料网状材料,诸如PET(聚对苯二甲酸乙二醇酯)、PEEK(聚醚醚酮)、或尼龙(各种聚酰胺)。固定器的大部分外表面可以被柔性外皮包覆,其允许固定器形状和状态根据需要不受阻碍的变化。该外皮不应该允许在组织内生长、不能够渗透液体、且基本不能够固有地伸缩。该外皮可在或朝向固定器的每个相对端部附接,以包绕至少大部分固定器但不嵌入它。该外皮可贴身地顺应处于展开状态的固定器。该外皮阻止液体从固定器外侧穿过固定器。
还可以使用保持固定器或锚闭合的其他部件。这些部件包括将锚保持在闭合位置的机械绑接绳或包裹物,它们可在安装后被移除。锚的扩张也可在管安装后电气地或磁性地触发。固定器的另一配置在图7中示出,其示出了固定器为可充气球囊。具有非充气状态的球囊的轴杆34可穿过前述的瘘口插入,并且球囊在其处于盲肠内后被充气。用于球囊的单独充气管腔是需要的。
在又一实施方式中,上面刚描述的球囊固定器可包含泡沫,诸如聚氨酯泡沫体,这是理想的开孔。所述泡沫可通过从球囊中移除空气来折叠。在折叠配置中,固定器非常小,且具有球囊的轴杆可通过瘘口插入体内。在插入后可允许空气被动地重新进入球囊中以使得泡沫扩张接近其原始尺寸。可替代地,球囊可通过注入空气而积极地膨胀,再次引起泡沫膨胀并基本填满球囊内部。球囊中包括泡沫且不单独依赖空气以保持形状的好处在于,在球囊泄露的情形中,泡沫将保持就位且将管保持在合适位置。仅具有空气的球囊会泄气且使得管滑出或意外地从瘘口移除。
在盲肠造瘘管30被插入后或在盲肠紧密接触腹壁后,可在这两者之间注入外科密封剂、粘合剂或胶水。该粘合剂快速干燥,并且一旦粘合剂已经干燥,盲肠和内腹壁稳固地保持在一起而不需使用缝合线。粘合剂应该持续六周时间,这认为是瘘口稳定且保持就位所必须的时间段。在六周后,认为粘合剂将被身体吸收且处理。然而,粘合剂的使用是可选的,因为一些外科医生会认为无需考虑固定器的尺寸和稳定性,它们通过自身可足以保持盲肠抵靠腹壁六周直至瘘口成熟且稳定。
粘合剂可通过沿盲肠造瘘管30外侧、内侧或壁内定位的管腔注入。轴杆34的远端具有用于粘合剂的至少一个出口,以及期望地多个出口,所述出口定位在盲肠造瘘导管或轴杆34的外表面上,以使得绕轴杆34并在轴杆34的整个长度上分布。图5A示出了粘合剂分配器44,其可用于将粘合剂注射至管腔38中。管腔38通过至少一个端口(未示出)与轴杆34的外侧流体连通。
适于该应用的粘合剂是那些含有单体单元的粘合剂,单体单元在原处聚合以形成聚合膜。含有氰基丙烯酸烷基酯单体的氰基丙烯酸盐密封剂是该类型的实例,其中单体聚合物在诸如水或蛋白质分子的极性种属存在时形成丙烯酸膜。溶剂基粘合剂在该应用中是不合适的,这是由于它们使用溶剂挥发的原理来运作,它们当然不能在体内发挥作用。
一种在皮肤密封剂成分中可用的合适粘合剂,商业上公知为并可从英格兰普利茅斯的Medlogic Global有限公司获得。皮肤密封剂包含医疗级的n-氰基丙烯酸正丁酯单体(80%w/w)。医疗级的氰基丙烯酸盐是二次蒸馏的。非医疗级的氰基丙烯酸盐相反是单次蒸馏且通常市售为“超级粘合剂”型的粘合剂,用于将各种各样的基层胶合在一起。另一种成膜剂是Hard,如甲苯磺酰胺/甲醛树脂(Del Laboratories Inc.,Uniondale NY)。又一种合适的粘合剂作为伤口缝合粘合剂市售,其商标名为Medlogic的
一旦盲肠已经附接至腹壁的内表面,保持其就位的粘合剂已经硬化,并且固定器在盲肠中展开,盲肠造瘘管的安装完成。通常不需要任何后续医疗程序。然而可能的是制作盲肠造瘘装置的材料会随时间退化。在该情形中,可以移除并更换盲肠造瘘装置。
为了引入顺行灌肠剂,闭合链40(存在时)从盲肠造瘘管(图3A)的近端或“头部”36移除,在那里它通常弯曲并以保持开口42闭合的方式插入。通过开口42引入灌肠剂溶液至管腔(未示出),其穿过管30的轴杆或导管34并终止于固定器32,期望地处于中间。灌肠剂溶液然后离开固定器进入盲肠。期望的是管30内的阀位于头部36或轴杆34中。该阀期望的是单向阀,如鸭嘴阀。该阀用于在管不使用时防止管30将流体泄露在体外,这是现有技术中已经确定的问题,并且它会引起气味、窘迫、和衣服沾污的问题。
在与现有技术的Chait TrapdoorTM装置对比时,管30的轴杆34中的管腔短且直,其从开口42延伸至固定器32,这使得它较不可能被阻塞。现有技术的装置,特别是“猪尾”或线圈,使得现有技术的装置的管腔相比所公开装置的管腔更长。另外,所公开的管30期望地具有相比现有技术的装置来说更大直径的管腔,这也有助于阻止堵塞。更大直径和更短长度的管腔的结果是使得所公开装置能够在由于阻塞而更换前保持在体内更长时间成为可能。现有技术的装置通常按规定时间更换,通常是每年一次。
管30内阀的位置还帮助防止从装置泄露。该阀可期望地是单向挡板阀或鸭嘴阀。可替代地,但较不期望地,所述阀可以是扭转式阀,其在一个方向上扭转时关闭而在另一个方向上扭转时打开。可以使用公知的具有该服务功能并对本领域技术人员公知的任何其他阀。
所公开装置的尺寸是大约的,这是由于针对不同年龄和体型的个体具有不同的尺寸。然而,通常的导管或轴杆的外部尺寸是:12French(4.0mm),具有从0.8cm至4cm的瘘口长度;14French(4.7mm),具有从0.8cm至5.0cm的瘘口长度;18French(6.0mm),具有从0.8cm至5.0cm的瘘口长度;20French(6.7mm),具有从0.8cm至5.0cm的瘘口长度;以及24French(8.0mm),具有从1.5cm至5.0cm的瘘口长度。固定器期望地在完全展开或打开配置时具有其所附接的轴杆的外径的至少两倍的直径或长度。它可具有其所附接的轴杆的直径的至少三倍或甚至四倍的宽度。
还期望但非必要的是盲肠造瘘管具有抗菌化合物涂层以帮助减少感染的可能性。合适的抗菌化合物包括含银涂层和聚硅醚。还可使用对本领域技术人员来说公知的其他这类材料。
如本文和权利要求书中所使用的,术语“包括”是包容且开放性的,并且不排除另外的非列举元件、组成成分、或方法步骤。
虽然各个专利已经通过引用包含于此,但所包含材料和所写说明书之间具有任何不一致时,所写说明书应该主导。另外,虽然本发明已经关于特定实施方式进行了详细描述,但对于本领域技术人员来说明显的是,可以在不偏离本发明精神和范围的情况下对本发明做出修改和其他改变。因此权利要求书旨在覆盖由所附权利要求书包括的所有这些修改、替换或其他改变。
Claims (12)
1.一种盲肠造瘘管,包括:
头部,所述头部限定从中穿过的开口;
所述头部还在所述开口中限定阀;
柔性导管,其限定第一管腔并具有近端和远端,所述导管的近端与所述头部中的开口流体连通,所述导管的一部分离开所述头部延伸以限定所述远端,所述导管具有壁部,其从所述头部中限定的开口至所述导管的远端限定内表面和外表面;
固定器,其设置在所述导管的远端上,所述固定器具有第一轮廓和第二轮廓,所述第二轮廓大于所述第一轮廓,并且适于将所述盲肠造瘘管保持就位于体内;以及
第二管腔,其适于从所述头部至导管外表面输送粘合剂。
2.根据权利要求1所述的盲肠造瘘管,其中所述第二管腔能够沿所述导管的外表面在所述头部和所述固定器之间输送粘合剂。
3.根据权利要求2所述的盲肠造瘘管,其中所述粘合剂是在水或蛋白质分子存在时聚合的单体。
4.根据权利要求1所述的盲肠造瘘管,其中所述固定器从第一配置改变为第二配置,所述第一配置比所述第二配置小以用于将所述固定器插入体内,所述第二配置适于将所述盲肠造瘘管保持就位于体内。
5.根据权利要求4所述的盲肠造瘘管,其中所述固定器响应于与流体的接触从所述第一配置改变为所述第二配置。
6.根据权利要求5所述的盲肠造瘘管,其中所述固定器在插入前通过凝胶胶囊保持为所述第一轮廓。
7.根据权利要求5所述的盲肠造瘘管,其中所述固定器在插入前通过凝胶涂层保持为所述第一轮廓。
8.根据权利要求4所述的盲肠造瘘管,其中所述固定器是球囊。
9.根据权利要求8所述的盲肠造瘘管,其中所述固定器通过充气从所述第一配置改变为所述第二配置。
10.根据权利要求8所述的盲肠造瘘管,其中所述球囊包含泡沫。
11.根据权利要求2所述的盲肠造瘘管,其中所述第二管腔具有用于所述粘合剂的多个出口,所述出口定位在盲肠造瘘导管的外表面上,以使得所述粘合剂绕所述导管并在所述导管的整个长度上分布。
12.根据权利要求1所述的盲肠造瘘管,其中所述阀是单向阀,选自由挡板阀和鸭嘴阀组成的组。
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US13/247,249 US8795236B2 (en) | 2011-09-28 | 2011-09-28 | One step cecostomy |
PCT/IB2012/054111 WO2013046071A1 (en) | 2011-09-28 | 2012-08-13 | One step cecostomy |
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JP (1) | JP5697806B2 (zh) |
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AU (1) | AU2012313911B2 (zh) |
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CN103405297A (zh) * | 2013-08-27 | 2013-11-27 | 林建江 | 完全转流型肠造瘘管 |
US10792472B2 (en) * | 2017-02-22 | 2020-10-06 | Covidien Lp | Apparatus and associated methodologies for creating a stoma |
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2012
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MX2014002878A (es) | 2014-04-10 |
JP2014527892A (ja) | 2014-10-23 |
CA2847574A1 (en) | 2013-04-04 |
EP2760388B1 (en) | 2016-04-20 |
US8795236B2 (en) | 2014-08-05 |
JP5697806B2 (ja) | 2015-04-08 |
CA2847574C (en) | 2015-09-22 |
EP2760388A1 (en) | 2014-08-06 |
AU2012313911B2 (en) | 2015-07-16 |
CN103841930A (zh) | 2014-06-04 |
US20130079712A1 (en) | 2013-03-28 |
WO2013046071A1 (en) | 2013-04-04 |
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