CN101810521A - 饱满装置和方法 - Google Patents

饱满装置和方法 Download PDF

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CN101810521A
CN101810521A CN201010150945A CN201010150945A CN101810521A CN 101810521 A CN101810521 A CN 101810521A CN 201010150945 A CN201010150945 A CN 201010150945A CN 201010150945 A CN201010150945 A CN 201010150945A CN 101810521 A CN101810521 A CN 101810521A
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stomach
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CN101810521B (zh
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R·S·斯塔克
W·L·阿塔斯
M·S·威廉斯
T·J·莫蒂
F·E·斯维斯泰恩
N·埃维伊
W·S·小尤班克斯
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Boston Scientific Scimed Inc
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Synecor LLC
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Abstract

本发明涉及饱满装置和方法。本发明涉及一种诱发患者体重减轻的装置，其包括位于胃食管接界区的管状假体，优选在z-线下方。在诱发体重减轻的方法中，安放该假体以打开器近端接收来自食管的经咀嚼食物，并且经咀嚼的食物穿过该囊并且经过其远端开口进入胃内。

Description

饱满装置和方法
本发明是申请号为03812874.8、申请日为2003年2月13日的发明专利申请的分案申请。
发明领域
本发明一般性涉及使人体实现体重减轻的装置和方法的领域，并且特别涉及可植入人体胃内用于控制饥饿感的装置的应用。
发明背景
多种医学途径被用来控制肥胖。这些途径包括节食、药物和手术方法。一种较成功的外科方法是垂直带圈的gastroplexy或采用Roux-en-Y吻合术完成的近端胃囊，以便分流食物使其不能由胃的近端区进入肠，由此最大限度地减少食物吸收到血流中。然而，已知这些方法各自都存在并发症并且人们需要更加成功的选择。
其他方法包括植入胃球(gastric balloon)，由此通过占据胃内的容积来防止饮食过量。不幸地，胃球可以向下转移到GI道，引起阻塞并不得不将其除去。
因此希望提供成功的介入性最低的方法来代替现有方法达到控制肥胖。
发明内容
发明概述
一种利用本发明原理的饱满装置包括一个可定位在胃食管接界的管状囊。该囊具有一个接收来自食管的摄入食物的近端开口，和一个将该囊内食物传送到胃内的远端开口。该囊成比例，以使食物自该囊进入胃内的传送活动进行得较为缓慢，导致食物蓄积在该囊内，使患者有发胀感。
附图简述
图1是一人体胃和部分小肠的示意图。
图2是与图1类似的示意图，表示胃囊的体内位置。
图3是一传送体系的截面侧视图，其可以用于传送一个饱满装置例如图2的囊。
图4A是图3的传送体系的推进管的截面端视图。
图4B是可以用于图3的传送体系的推进管的另一截面端视图。
图5是图3的传送体系在传送囊进入胃食管接界过程中的截面侧视图。
图6进一步说明将囊传送到胃食管接界内。没有显示该传送体系，从而使囊和缝线更容易看清。
图7举例说明图6的囊的最后位置。
图8是另一种使用缝合圈的囊的透视图。
图9A和9B分别是另一使用缝合圈的囊的透视图和顶部平面图。
图10是使用缝合圈的囊的另一实施方式，并且举例说明另一囊的形状。
图11是一个表示使用缝合圈的囊定位在胃食管接界的示意图。
图12是类似于图11的示意图，表示包括独立可植入缝合圈的另一囊。
图13A和13B是示意图，表示使用的同轴折叠(plication)装置，其中图13A表示在圈已经定位后该导管的位置并且图13B表示折叠的形成和锁圈的放置。
图14A是一表示另一折叠装置的示意图。
图14B是一利用图14A的装置的组织的折叠的透视图。
图15是一可膨胀囊的透视图。
图16是表示图15的使用传送装置传递囊的示意图。
图17举例说明另一胃囊的体内位置。
图18A是图17的胃囊在一个用于传送的定位管套内的透视图。
图18B图17的胃囊在展开过程中的透视图。囊显示出被从定位管套传送但仍然与轴柄相连。
图19是另一胃囊实施方式的透视图。
图20A是另一胃囊的透视图，其采用旋管构型。
图20B是图20A的胃囊的截面侧视图。
图21A是一示意图，表示与胃囊组合的基底支架。
图21B是类似于图2A的示意图，但进一步说明与胃囊和支架组合的对齐(alignment)伸展部。
图22A表示另一胃囊实施方式。
图22B是图22A的胃囊侧壁的截面图。
图22C是图22A的胃囊的远端斜槽区的透视图。
图22D是代替图22C的远端斜槽区的一种远端斜槽区的透视图。
图23是另一传送装置，齐可以用于传送胃囊。
图24A和24B是图23的传送装置的端视图，分别表示在开口位置和闭合位置的爪。
图25A和25B是一系列的侧视图，其表示饱满装置在用传送装置植入之前通过传送装置进行的衔接。
图26表示另一胃囊的透视图。
图27A和27B是顶部平面图，表示图26的实施方式中使用的圈类型。图27A中显示该圈处于压缩状态并且在图27B中处于自然的、展开状态。
图28A是饱满囊的另一实施方式的透视图。
图28B是图28A的囊的体内定位的示意图。
图29图示穿过食管的囊的体内定位。
图30图示另一穿食管的囊的体内定位。
图31是具有可调节远端开口的饱满囊的正视图。
图32A是具有另一可调节远端开口形式的饱满囊的正视图。
图32B是图32A的囊的可调节限定器圈的顶部平面图。
图33是具有另一可调远端开口形式的饱满囊，和一可用于调整该远端开口的工具的侧视图。
图34A和34B是表示图33所示的工具的远端分别处于收回和伸展状态的侧视图。
图35A和35B是图33的囊的可调限制器圈的顶部平面图，表示该环处于伸展和收缩状态。
图36A-36D是一组示意表示从患者中取出饱满囊的图。
图37是囊摘取工具的截面侧视图，其可以与图36A-36D所示的工具组合使用。
图38A和38B是胃和食管的示意图，表示具有安全束缚的饱满囊。
具体实施方式
发明详述
图1中图示了人体胃S和有关特征的解剖学图示。食道E将口腔的食物传递给胃S。z-线或胃食管接界Z是位于食管的薄组织与胃壁的较厚组织之间的不规则形状的边界。胃食管接界区G是包括食道E的远端部分、z-线和胃S的近端部分的区域。
本文描述饱满装置的多种实施方式。这些装置的许多包含一个位于胃食管接界区的囊或漏斗以形成一个收集来自食管的咀嚼过的食物的小储库-由此同时限制食物可供消耗的食物的量。随着时间，该储库内的食物经该囊的远端开口下降到胃内。该囊可以选择性地包括可定位在食道内以促进食物由食道流入囊内的管状延伸。
可用于该囊的材料包括防止食物穿过囊边侧的柔韧性材料。此类材料的实例包括，但不限于聚酯(例如Dacron
Figure GSA00000070794800041
聚酯)，ePTFE织物(例如GoreTex
Figure GSA00000070794800042
织物或其他)，聚氨酯例如ChronoFlex
Figure GSA00000070794800043
聚氨酯，尼龙织物，硅氧烷，其他聚合性材料，和生物可吸收材料(例如PLLA，PGA，PCL，聚amhydride等)。囊12可以由挠性、半挠性和/或非挠性材料的复合材料构成，它们使不同区域的囊具有不同程度的挠性，由此允许/限制囊在不同位点的拉伸。譬如，希望得到具有相当弹性出口的囊，从而防止在摄取大块食物的活动中发生闭塞，而囊的近端可以较硬以防止膨出。通过改变囊不同区域内囊截面厚度还可以使囊具有不同程度的挠性。囊材料可以用平滑的、生物相容的、化学惰性材料如paraleyne覆盖，从而减少基底上的摩擦。
柔韧性囊材料可以由支持结构来运载，例如软网、线圈、支架结构、肋板、圈等。支持结构可以由不锈钢、聚合物、形状记忆材料(例如镍钛金属互化物(nitinol)，形状记忆合金，或形状记忆聚合物)、生物可吸收材料构成，或者，在硅氧烷囊的情况中，由增厚区域的硅氧烷构成。支持结构可以位于柔性囊材料的内部或外部。可以将其模制到或缝合到囊材料中，或者可以用适当粘合剂将其粘附。如果使用紧密编织的网或紧密变形的线圈时，可以除去柔韧性囊材料。另外，网可以在网空隙内嵌入聚合物材料，在这种情况中可以除去囊材料的独立内部或外部覆盖物。
优选所述的囊构建为能够自行扩张，使该囊在由下文详述的展开装置或导管喷出时径向弹开成为展开状态。
在许多实施方式中，该囊形成漏斗形状。然而，许多其他形状也可用于所述的囊。譬如，该囊可以具有较短的近端至远端尺寸并由此呈浅碟的形状并且在其底部表面具有一个小孔。其他实施例包括，但不限于，卵形，其他锥形例如“陀螺”的形状，圆柱体形状，和其他对称或不对称形状。
所述的装置可以模块化，其中植入多种组件。许多组件可以彼此分开提供。在这样的模块体系中，分开植入的组件可以在植入过程中彼此连接位于壳体内，或者其中的某些组件即使在植入后也是彼此不相连。另外，医师可以在植入之前即时将组件彼此装配。模块组件是理想的，其中它们允许医师针对患者选择适当大小的各种组件。
饱满装置的一个实施方式如图2所示并且包括位于胃近端区内的囊12。囊12包括可定位在胃食管接界区的所示近端开口14(并优选低于z-线)，和向胃S内部打开的远端开口16。在这种实施方式中，囊12由近端开口向外逐渐锥形变细构成工作裙18，并且随后向内逐渐锥形地朝远端开口16变细，使囊12的远端部分呈漏斗形状。然而，许多其他形状也适用于所述的囊。譬如，囊可以具有非常短的近端至远端尺寸并由此成为浅碟的形状，同时在其底表面具有一个小孔。
由于其体积小(其体积可以在约2cc-300cc的等级，但优选在10-30cc的范围内)，囊的作用在于限制可被同时消耗的食物的量。囊12可以由防止食物穿过囊侧的柔韧性材料构成，例如Dacron
Figure GSA00000070794800051
聚酯，硅氧烷，或其他聚合物材料。囊12可以由挠性、半挠性和/或非挠性材料的复合材料构成，其使囊的不同区域具有不同程度的挠性。此类复合材料允许/限制囊延伸到不同位置，由此有助于控制食物材料经过该囊的穿过速度和/或食物自该囊的排放压。如果使用硅氧烷，通过改变囊的不同区域内的囊截面厚度可以为该囊构建不同程度的挠性。囊材料可以可以用平滑的、生物相容的、化学惰性材料如paraleyne覆盖，从而减少基底材料的表面上的摩擦，这有助于防止粘着和食物堆积在该装置上。
在植入过程中，囊12用缝合、夹子、粘合剂或其他适当方式固定在胃食管接界区G。尽管该囊可以固定在食管组织，更优选在Z-线下使用缝合/夹固从而将其附着在胃壁的较厚的组织上。缝线附着点，在该囊内可以采取洞、孔眼或扣眼的形式20，其可以用于胃固定缝线提供加固区。虽然可以根据需要使用可多可少的此类缝合/夹固附着点，但需要至少四个这样的点，例如在该囊四周以90°的间隔，由此确保该囊被固定在组织的整个周缘上。缝合附着点可以由适当密度的射线不透性材料组成，例如钛或金，从而在操作过程中或之后使该装置可见。各缝合附着点也可以用不同颜色标记以便易于缝合的识别和定向。如果该囊由硅氧烷组成，该囊的近端部分(其中孔眼20被定位)可以在硅氧烷内由更耐用的材料构成，例如织物材料，Dacron
Figure GSA00000070794800061
聚酯或ePTFE织物，从而得到更耐用的缝合区。虽然扣眼，孔眼或加固区可以有利，但也可以提供没有由特殊材料组成的缝合附着点的囊(有或无识别标志)-在这种情况中缝合直接穿过囊材料。
柔韧性囊材料可以通过支持体携带，例如软网、支架结构、肋板、圈等。支持体可以由不锈钢、聚合物、形状记忆材料例如镍钛金属互化物、形状记忆合金，或形状记忆聚合物构成，或囊材料的增厚区构成。优选使该囊构建为能够自行扩张，使该囊在由下文详述的展开装置或导管喷出时径向弹开成为展开状态。
图3表示一种传送体系22，它可用于植入囊12以及任何本文所述的其他饱满装置。传送体系22包括伸长管套24和可在该套内滑动接受的推进管26。管套24包括一个远端28，其略成锥形且由柔韧性材料例如低硬度聚乙烯组成，从而最大限度减小由于末端28运动到食管和胃中并在其中运动时与机体组织接触造成的创伤。
推进管26是沿管套24延伸的伸长管且略微自管套24的近端延伸。手柄30可以在该推进管26的近端形成以便于促进该推进管相对于管套24运动。推进管26包括中空腔32，用于容纳植入位置所需的装置。此类装置可以包括，例如，可以使植入物操作可见的内窥镜34，或其他确保植入物适当放置可能需要的装置。许多圈形腔36(图4A)和/或沟槽38(图4B)位于推进管26内的周缘。在使用过程中，缝合线可以定位在这些腔/沟槽内由此使缝合线彼此分开。
参见图5，在囊12的植入准备中，缝合线40固定在囊的孔眼20处，并且该囊折叠或卷起并置于管套24的远端。各缝合线的近端拖拉处管套24的近端并经推进管26的腔36(图4A)或狭槽36(图4B)穿过。各缝合线的远端拉出管套24的远端。该缝合线可以颜色不同或具有不同的有色图案-它可以对应于囊上缝合点的颜色，从而能够轻易识别和区别各个缝合线。其次，推进管26进入管套24内使其远端面对折叠的囊12。
管套24的远端经食管穿过并进入胃。缝合线40的自由远端缝合穿过食管开口四周的组织，适宜恰好在Z线下方。该缝合可以根据需要在内窥镜指导下连接，使用常规缝合技术。参见图5和6。管套24没有在图6中表示，使漏斗和缝合可以看得更清楚。
一旦缝合线已经固定到组织时，推进管26用手柄30向远侧方向推进。推进管26使囊12离开管套24的远端开口。管套24用孔眼20定位在缝合位置，如图7所示。结42扎束各个缝合并沿缝合的长度滑动向组织，由此将囊固定在一定位置。
一旦植入，囊限制了患者食道内的食物进入到胃的通道。可以相信由于收集食物并保持在该囊的储库内，胃基底和胃食管接界区中的压力感受器将诱发饱满感。重力和柱状力将驱使食物通过储库的限制口并进入进行正常消化的胃内。
图8表示囊44的第二种实施方式。囊44包括弹性或半挠性材料(例如，耐用聚氨酯高弹体例如ChronoFlex
Figure GSA00000070794800071
聚氨酯，硅氧烷，ePTFE网或织物，Dacron
Figure GSA00000070794800072
网或织物)。所述的囊还可以由挠性(或半挠性)和非挠性材料的复合材料构成由此使该囊具有不同挠性的区域。囊44可以包括加固结构例如螺旋肋板或圈46-其可以由镍钛金属互化物、不锈钢、塑料等组成。加固结构可以模制或缝到囊材料内，或可以用适当粘合剂粘合。可以含有或不含有孔眼的缝圈48在近端开口50四周形成圈。对于所有图示的实施方式，所述的囊可以向内朝着远端开口52锥形地逐渐变细以形成漏斗形状-或者所述的囊可以具有一种不同的上述其他形状。
第三种囊54如图9A和9B所示。囊54类似于图8的囊但在缝圈62中进一步包括孔眼56，并且略呈圆柱状的滑槽58与远端开口60相邻。第四种囊63，如图10所示，也包括缝圈62a，但区别在于其整体形状是较浅且小的漏斗形。
如图11所示，使用缝圈65的囊(例如图8的囊44，图9A的囊54，或图10的囊62)优选缝合或折叠定位或者附着在胃S上部的组织。希望这种定位是为了避免缝合在较薄的食管组织。由于胃壁的组织比食管组织厚，所以可得到更可取的缝合表面：或者，如图12所示，可以是镍钛金属互化物或聚合物的缝圈64可以与有关的囊66分开植入，并且在引入囊66之前缝合进入或折叠到胃组织内。此后，引入囊66且用缝线、夹子或其他附着机构与圈64连接。
为了便于囊的缝合，例如本文所述的那些囊，可能希望在组织内的胃食管接界区用缝线形成褶-以类似于治疗胃肠反流疾病中进行的打褶或″系带″操作方式。此类组织的褶适宜在胃组织内z-线下形成，并且径向地由胃壁向内少量伸展。这些折叠在附着囊过程中更便于接纳缝合针或夹子并由此易于囊的植入。
两种在胃组织内形成褶叠的机构如图13A、13B和14A、14B所示。参见图13A，第一折叠装置包括具有中央开口67和多个间隔开周缘开口69的圈68。圈68可定位在所示的近侧胃(如果需要使用管套以便于插入和放置)，由此使周缘开口69与食管远端开口四周的胃组织接触。导管72可经中央开口67延伸。参见图13B，组织拉具70可经导管纵向移动。组织拉具70可以采取具有螺旋顶的延伸线的形式-但也可以采取其他能够连接和拉拖组织的形式。
具有中央开口的柔性锁圈71成形为接合经其拉拖的组织(例如星形开口)，该锁圈可经导管72和拉具70移动。
为了用图13A、13B的装置将胃食管接界区的组织打褶，圈68可相对于图13A所示的胃组织进行定位。导管72穿过中央开口67，并且其远端被引导至圈68内的一个开口69下方的位置。参见图13B，该拉具70预先穿过开口69直至它接触圈68上方的胃组织，并且随后通过从开口69收回拉具70将连接的胃组织经开口69拉出。可以通过导管72施加真空，以协助组织经开口69拉出。保持拉具的收回，使锁圈71在导管72和拉具70中前进，并且进一步沿组织的锥体C向下前进穿过开口69-导致组织锥体通过星形开口延伸到锁圈内并由此形成褶叠。该锁圈利用星形开口形成的点锁住组织来保持褶叠。可以使用其他倒钩或钩子以便于锁定。这种方法可在圈68中一些或全部剩余开口69中采用以将多个锁圈71连接在食管周边的胃组织-由此在食管四周形成褶叠。囊例如本文所述的那些此后缝合成褶叠，或者用缝线、夹子、粘合剂或其他适当装置与圈68相连。
另一种折叠装置如图14A和14B所示并且包括具有多个周缘开口74的环形圈73。圈73可以由弹体材料构成。多种折叠夹75包括颚式元件，其延伸穿过图14B所示的圈73中的相邻开口74。可分离驱动器77能够打开和关闭折叠夹75的颚式元件。为了折叠组织，圈73定位在胃-食管接界区，同时其上表面与近侧胃的组织相接触，围绕在对食管的开口处。折叠夹的颚式元件穿过开口74并用于抓紧组织，如图14B所示-由此在组织内形成褶叠并将该圈保持在一定位置。关闭颚式元件，并且利用其间抓握的组织锁定在闭合位置。驱动器77与夹子分离，使圈和夹子留在适当位置从而维持组织内的褶叠。随后可以将饱满囊缝合在本文多种实施方式所述的组织内的褶叠，或用缝线、夹子、粘合剂或其他适当附着方式与圈73相连。
图15和16表示囊78的实施方式，其不同于在前的实施方式，其中它形成为具有气室79、接近近端开口80的膨胀阀82和可分离膨胀管84的可膨胀杯。缝合孔眼86围绕在近端开口。当囊78自展开套管88展开到胃内后(参见图16)，由注射器通过注射充气介质(例如空气或盐水)到膨胀管84内使其膨胀，并且囊与阀82和管84分离。当希望除去囊时，刺透囊78并放气，随后用内窥镜爪钩或类似工具经食道拉出。
参见图17、18A和18B，囊90由圈92组成，圈92由自行扩张材料组成，例如不锈钢、镍钛金属互化物或形状记忆聚合物，用材料例如Dacron
Figure GSA00000070794800091
聚酯、ePTFE织物或其他当缝合到相邻机体组织时耐用的聚合物覆盖。圈92任选地与肋板94连接在一起，它也可以由形状记忆材料组成。
囊90的远端锥形地逐渐变细进入滑槽96。滑槽96可以由类似于囊的材料组成，或者可以由弹性聚合物组成，例如低硬度聚乙烯、硅氧烷、高弹体聚氨酯材料等。由此允许滑槽径向扩展。这种响应滑槽所携带食物原料的累积的扩展可能是需要的，从而防止滑槽堵塞。滑槽96可收缩且由此发挥检查阀的作用-防止原料由胃回流到囊中。
环形缝合区98位于囊的近端。在植入过程中，缝合与缝合区相连且固定在相邻组织。为了便于囊在适当位置的缝合，希望用缝线在胃食管接界区形成组织褶叠-以类似于治疗胃肠回流疾病中进行的打褶或″系带″操作方式。此类组织褶径向地由胃壁向内少量伸展。这些折叠在连接囊过程中更便于接纳缝合针或夹子。
囊90可用传送体系提供，该传送体系包括经囊90延伸的伸长轴柄100。鼻锥体102与该轴柄的远端相连，并且包括导线104。鼻锥体102优选为柔韧性和自由的尖锐或钝边，从而防止植入过程中组织创伤。
如图18A所示，囊90折叠且包装在定位管套106内，该管套由聚合物例如线加固的pebax、FEP、ePTFE或其他适当材料组成。该囊围绕该轴柄折叠，并且折叠的囊和轴柄此后定位在管套内。可以采用多种折叠技术来达到此目的。折叠的囊可以包括双向褶叠，或者重迭褶叠。此类褶叠的实例包括螺旋褶叠、兔耳形褶叠、鞍形褶叠或三叶草叶褶叠。
当植入所述的囊时，将该管套106(位于囊内)引入到食管内，同时导线104首先穿过食管并进入胃。一旦缝合区98到达胃-食管接界区，抽出管套106，使该囊因圈92的自行伸展性而弹为如图18B所示的展开状态。按照图18B中箭头所示向中央轴柄施加轻微的张力，从而使缝合区98被环绕食管远端开口的组织支撑-或被上述组织内的褶叠支撑。当缝合区98以这种方式被组织支持时，缝线穿过缝合区和周围组织，由此将该囊固定到图17所示的位置。一旦该囊已经缝合到适当位置，从患者中抽出轴柄，只将该囊留在适当位置。缝合后，将轴柄推到胃内，其中可伸展鼻锥体倾向于直径小于漏斗的远端开口，并且经漏斗和食管撤除。
参见图19，另一种囊108可以由支柱110或由镍钛金属互化物、不锈钢、聚合物组成的(包括形状记忆聚合物)组成的网构成。圈112连接在该装置近端处的支柱/网，并且也可以由镍钛金属互化物、不锈钢、聚合物(包括形状记忆聚合物)组成。该囊的外部或内部被可防止食物穿过囊侧的材料114覆盖。此类材料的一个实例是聚酯材料，例如DuPont公司出售的Dacron
Figure GSA00000070794800101
聚酯。
图20A和20B表示囊120的另一实例。囊120由形状记忆线圈组成，该线圈已经被加热成为漏斗形状。Dacron
Figure GSA00000070794800102
聚酯或其他材料122(图20B)可以任选地覆盖该线圈的内壁或外壁，虽然该线圈自身可能足够小到防止食物迁移通过该线圈的侧壁。材料122可以挤压在最近的线圈124及其相邻线圈之间，如图20B所示，由此使其固定在适当位置。
对于本文所述的其他囊，图19-20B提供的囊108、120可以具有相当长的近端至远端尺寸(例如约1.5-5.0cm的等级)并且由此使该囊成如图19和20A所示的漏斗形状。然而，许多其他形状可以用于该囊。譬如，该囊可以具有非常短的近端至远端尺寸并由此采取浅碟的形状并且在其底表面带有小孔。
胃囊也可以是较大饱满装置的一部分。譬如，参见图21A，囊125的近端部分可以连接较大支架结构126的近端。支架126自食道扩展到胃窦A的近端部分。它可以是大的展伸状结构，优选由自行扩展材料组成，例如不锈钢或形状记忆材料例如镍钛金属互化物或聚合物。支架126主要起使胃扩张造成饱满感的作用。按照所示，囊125悬浮在支架126的内部。
另外，囊125(使用或不使用支架126)也可以使其近端与对齐伸展部128相连。参见图21B，对齐延伸部128是一延伸到食管内的管状展伸部分。在一实施方式中，延伸部128的长度可以约为5cm。它主要起使囊的近端开口与食管成直线的作用-由此食物经过食道，很容易进入该囊内。
该囊装置的另一实施方式如图22A所示。囊130优选由硅氧烷材料组成。该囊的不同区域中囊壁的截面厚度可以不同，由此允许/限制不同位置的囊的扩展。硅氧烷或其他材料可以被光滑的、生物相容的、化学上惰性的材料覆盖，例如paraleyne，以便减小对基底材料表面的摩擦，由此有助于防止粘着和食物堆积在该装置上。
可以提供支持元件例如环形圈132和/或径向肋板134(图22C)。如果使用，此类支持元件可以由硅氧烷的增厚区组成，或它们可以被塑料或镍钛金属互化物组分分开。在一种实例中，如图22A所示，具有波形的镍钛金属互化物圈可以赋予囊130以结构。
颈部136位于囊130的近端并可定位在胃食管接界区内。在植入过程中，用缝线和夹子将颈部136固定在食管组织和/或胃组织的四周。颈部136中的缝合孔、孔眼或扣眼138可以为固定缝线提供加固区。此外，该加固位置和材料可以由适当密度的射线不透性材料组成，例如钛或金，从而在操作中和之后使该装置可见。加固位置和材料可以具有不同的颜色，从而也使缝线可识别和区分。如果需要，全部或部分的颈部340可以在硅氧烷处由纺织材料组成，由此得到更加耐用的缝合区。
在囊130的远端形成滑槽140。滑槽140可以包括支持元件例如肋板134(或圈例如圈132)来为滑槽提供刚性。另外，可以使用可收缩滑槽例如滑槽140a，如图22D所示。该可收缩滑槽140a没有肋板支持并由此是足够柔韧的以进行收缩，以便为响应食物材料由胃回流运动到滑槽140a内。
漏斗装置在胃食管接界区的固定也可以通过使用生物相容形粘合剂、热融合或射频活化固定法达到。
囊130和本文所述的各种囊，可以用传送体系传送到胃食管接界区，例如与图3-5有关的一种体系，或使用其他种类的传送体系。其他传送装置142如图23所示。装置142包括多个自伸长套管146延伸的抓握爪144。爪144包括手柄148，它可以沿远侧方向移动使爪144朝远端前进且同时使该爪展开为图24A所示的打开状态。手柄148朝近端方向的运动使爪144收回成为图24B所述的关闭状态，并且同时将该爪拉到套管146的内部。
使用过程中，传送装置142使该囊的近端或远端或末端处的囊(例如囊130)边缘接合。当爪144关闭，它们折叠囊的末端，使其接合并将该囊拉向(或任选地拉进)套管146。如果该爪用来接合囊的远端，如图25A所示，该囊优选预先由内向外翻转，并且随后折叠回到爪144外，如图25B所示，从而覆盖该爪。被囊130覆盖的爪144穿过食管并进入胃内以放置该囊，优选在内窥镜指导下进行。一旦囊处于胃中时，该爪144打开释放出该囊。囊定位在胃食管接界区并将缝线经该囊的孔眼缝纫穿过相邻组织并打结以将该囊固定在适当位置。
胃囊还可以用作无缝线的唯一装置，并且反而可以在该囊结构的支柱、网或支架成形部分的径向扩张力作用下保持在适当位置。这样囊150的一个实例如图26所示。囊150包括由柔韧性聚合物、尼龙或Dacron
Figure GSA00000070794800121
聚酯组成的颈部152。多个圈154排列在该颈部内。参见图27A和27B，各个圈154包括中断部156，它允许圈径向压缩到适当状态，如图27A所示-同时中断部所形成的末端彼此略微重迭。释放对该圈的压缩导致其弹为环状，如图27B所示。
漏斗部分158位于该囊的远端。如上述实施方式所述，当植入囊时，颈部152排列在胃食管接界区(例如所示的远侧食道)并且漏斗部分158延伸到胃内。
在植入之前，囊150优选包在管套(没有图示)内并且全部的环呈压缩状态，如图27A所示。一旦将颈部置于食管内后，抽出管套，使圈154弹为展开状态，如图27B所示。展开的圈携带在食道的侧壁或胃食管接界区，保持颈部154与侧壁接触。其次颈部154的外部可以任选地带有钩子160，由此该圈的径向扩展使钩子与周围的侧壁相连。
图28A表示另一种囊162，它包括作为缝合区的颈部164。植入过程中，颈部164保留在胃-食管接界区内并且囊162的远端延伸到胃中。图28B表示，该颈部可以被固定在食管组织(虽然按照上文讨论相信Z-线下方的组织可能使更理想的附着点)。优选使用生物粘合剂将该颈部和相邻食管组织粘合以保持该囊在适当位置。如果使用缝线，设置在该颈部内的自行扩张圈166可以发挥缝合圈的作用-其四周可以固定缝线。远端处的滑槽167可以包括勺形阀，其作用是作为控制胃食管反流的检查阀。
穿-食管饱满装置的两种实施方式如图29和30所示。参见图29，囊168是由可变挠性材料组成的伸长柔性装置，所述材料例如ePTFE、Dacron
Figure GSA00000070794800131
聚酯、或聚氨酯例如ChronoFlex
Figure GSA00000070794800132
聚氨酯。囊168包括可定位在食管内并具有近端开口171的近端部分170。该囊进一步包括伸长中间段，和延伸到胃内并包括远端开口172的远端锥。该囊的柔性本质允许食管括约肌发挥正常功能。
该囊的近端部分170(其设置在相对于食管括约肌而言的近端位置)可以包括自行扩张的圆柱形伸展结构，它由形状记忆材料例如镍钛金属互化物、形状记忆聚合物或形状记忆合金组成并对周围侧壁产生径向压力，由此使其自身保持在食管内的适当位置。该伸展结构在其外表面包括倒钩以确保囊168无法移动离开该位置。另外，近端部分172反而可以用缝线或倒钩与周围侧壁相连。按照这种方案，该囊可以包括伸展结构或没有该结构。
图30的实施方式与图29的实施方式略有不同，不同之处在于其中它包括一个任选的束带限制器174，它调节食物从该囊中运动到胃内的速率。束带可以在植入过程中进行调节以选择适合该患者的流速。此外，可位于食管括约肌附近的任选挡板阀176有助于防止胃食管回流。远端开口172的勺形阀178也可以用来阻止胃食管回流。
饱满囊可以进行装配，使该囊远端开口的大小可以增大或减小。由此保证医师植入该装置使该远端开口适合患者的大小。在某些情况中，还允许医师在植入以后调整远端开口。譬如，如果患者没有以预期速度减轻体重，医师可以减小远端开口的尺寸-由此食物更加缓慢地自该囊排空到胃内。如果必要如果体重减轻得过快，医师还可以增大该远端开口的大小。
参见图31，可以在该囊的远端形成纵向切口180，以增加远端开口的有效尺寸。这些切口使用内窥镜剪刀在植入该囊后切割，或者可以在植入之前切割。该装置可以在进行切割之前穿孔或刻线以加速切割。
参见图32A和32B，囊182也可以在该囊外部四周-邻近该远端开口带有限制圈184。圈184可以在该圈内径内产生的扩张径向力作用下伸展(例如将抓握颚定位在漏斗内且随后分离颚)，或者向该圈的外部施加压缩力进行压缩(例如通过圈设置在颚之间并随后轻轻关闭它)。这种伸展/压缩可以在植入之前或者植入该囊之后进行。
图33表示具有可调远端开口的囊186的第三种实施方式。图33实施方式类似于图32A实施方式，其中它依赖于限制圈的伸展/收缩。限制圈188定位在邻近远端开口处的囊内。一对相对的狭槽190位于圈188的内表面。内窥镜可控调节工具192包括一对位于伸长轴196的远端末端的可延伸销子194。位于调节工具192的近端末端上的驱动器198a、b控制销子的延伸部处于限制状态(图34A)和伸展状态(图34B)之间。为了调整囊186的直径，该工具插入穿过囊并且销子194处于限制状态。销子194沿狭槽190深入圈188内且随后用驱动器198a伸展。当它们伸展后，销子194滑动到狭槽190内。此后，使用者沿其纵轴顺时针或反时针方向旋转该工具192。工具的形状展开或收缩该圈，这取决于旋转的方向。当圈的尺寸已经调整后，用驱动器198b收回销子194，并且随后从囊186取出工具192。
可以利用多种技术除去胃中的饱满囊。一种实例如图36A-36D所示。首先，如果采用缝线或夹子，内窥镜剪刀202经口腔和食管穿过并用来剪断缝线(图36A)或除去夹子。可能希望接合囊200，例如使用缝纫穿过该囊并伸出口腔的束带，或者内窥镜爪钩等，以防止囊在与胃食管接界区分离后进一步落入胃内。
其次，管套204穿过食道到达胃食管接界区。带有可伸缩爪208的取回装置206(可类似于图23的装置的那些)使其爪208处于关闭状态，并且穿过管套。打开爪208，位于囊200的近端部分的四周(图36B)，并且随后关闭，将该囊抓在爪之间(图36C)。随后经套管抽出爪208并从机体取出该囊(图36D)。为了便于取出，具有喇叭状远端的柔性护罩210可以经管套延伸且放置，从而在取出囊的过程该爪自管套远端伸长(参见图37)。当将囊抽到管套204内时护罩210协助指导囊达到压缩状态。一旦已经取出该囊，管套210经管套204从机体取出，并且随后取出管套。
参见图38A和38B，饱满囊212可以包括安全束带216，它使该囊212在将该囊定位的初级机构(例如缝线、夹子、粘合剂等)失败的情况中位于胃的近端区。束带216延伸自该囊并固定在胃壁的位点218。束带216可以用囊所使用类型的材料构成，或者使用所述材料的纤维加固带。在图38A和38B所示的实施例中，囊212的近端部分在附着点214处用缝线固定在适当位置。如果这些缝合连接会失败时，囊应用束带保持，并且防止迁移到胃的胃窦或幽门区，并且由此防止闭塞事件。
本文已经描述了饱满装置的各种实施方式。这些实施方式以举例说明方式给出而不对本发明的范围构成限定。此外应当懂得，所述的实施方式的各种特征可以以不同方式组合，从而得到许多其他实施方式。而且，虽然对所公开的实施方式描述了多种材料、大小、形状、植入位置等，还可以采用除此之外的所公开的其他方案而不超出本发明的范围。

Claims (40)

1.一种引发患者体重减轻的方法，该方法包括下列步骤：
提供具有近端开口和远端开口的囊；
将至少一部分的该囊定位在患者的胃内；
将该囊的近端部分固定在胃食管接界区内，使近端开口接收来自食管的食物，并且该远端开口位于胃内；和
使患者摄取的食物自食道流到该近端开口，并且从该远端开口进入到胃中。
2.权利要求1的方法，其中该近端开口的直径大于远端开口的直径。
3.权利要求2的方法，其中该囊具有近漏斗形状。
4.权利要求1的方法，其中该固定步骤包括将近端部分固定在胃食管接界区的Z-线下方的组织。
5.权利要求1的方法，其中该固定步骤包括将近端部分固定在胃食管接界区的Z-线上方的组织。
6.权利要求1的方法，其中用缝线固定该近端部分。
7.权利要求1的方法，其中用夹子固定该近端部分。
8.权利要求1的方法，其中近端部分用生物粘合剂固定。
9.权利要求1的方法，其中囊包括颈部并且其中在该颈部内形成近端开口。
10.权利要求9的方法，其中该固定步骤包括将所述的颈部固定在食管内。
11.权利要求1的方法，其中囊可从折叠状态扩展为展开状态，并且其中该方法包括该囊以折叠状态穿过胃，并且以展开状态扩展该囊。
12.权利要求11的方法，其中所述的囊是自行由折叠状态扩展为展开状态。
13.权利要求1的方法，其中所述的定位步骤包括将管套经患者的食道伸至胃食管接界区，并且使该囊穿过管套并进入胃内。
14.权利要求13的方法，其中该穿过步骤包括用推进工具推动该囊经过管套。
15.权利要求1的方法，其中定位步骤包括用抓握的颚元件抓紧该囊，将管套经患者的食道插入胃食管接界区，并且用抓握器携带该囊穿过管套并进入胃中。
16.权利要求1的方法，其中远端开口具有一定直径且其中该方法包括调整该远端开口直径的步骤。
17.权利要求16的方法，其中调整步骤使在固定步骤之前进行。
18.权利要求17的方法，其中该调整步骤使在固定步骤之后进行。
19.权利要求1的方法，进一步包括使该囊在胃中滞留预期长的时间，并且随后从胃取出该囊的步骤。
20.权利要求19的方法，其中取出步骤包括使管套穿过食管，用经管套伸出的抓握装置抓取该囊，并且把囊抽进管套。
21.权利要求20的方法，其中取出步骤进一步包括在抽出囊之前剪断位于管套和胃之间的缝线。
22.一种引发患者体重减轻的装置，该装置包括：
具有近端开口和远端开口的囊，囊成比例，由此当所述近端开口位于患者的胃食管接界区时，所述远端开口打开至胃内，使来自食道的食物直接经过进入近端开口，通过该囊且随后进入胃中。
23.权利要求22的装置，其中近端开口的直径大于远端开口的直径。
24.权利要求23的装置，其中该囊具有近漏斗形状。
25.权利要求22的装置，其中该囊自行由折叠状态伸展为展开状态。
26.权利要求25的装置，其中该囊包括至少一个结构元件。
27.权利要求26的装置，其中该结构元件由形状记忆材料构成。
28.权利要求27的装置，其中该形状记忆材料为镍钛金属互化物。
29.权利要求27的装置，其中该形状记忆材料为形状记忆聚合物。
30.权利要求26的装置，其中该结构元件由线圈构成。
31.权利要求26的装置，其中该结构元件由网构成。
32.权利要求22的装置，其中囊的近端部分包括缝纫区。
33.权利要求22的装置，进一步包括可位于胃的近端区中的支架，囊可与该支架的近端部分相连，由此使远端开口伸展到该支架的内部。
34.权利要求22的装置，进一步包括可位于食管远端区内的对齐管，该对齐管包括可与该囊近端相连的远端。
35.权利要求34的装置，进一步包括可定位在胃的近端区的支架，该囊可与该支架的近端部分相连以使远端开口延伸到该支架的内部。
36.权利要求22的装置，进一步包括与该囊的近端部分相连的颈部，该颈部可位于食管内。
37.权利要求22的装置，进一步包括位于该囊的远端部分的颈圈，该颈圈可压缩至第一直径并伸展为第二直径以改变远端开口的直径。
38.权利要求22的装置，进一步包括位于远端开口的单向阀，该阀取向为当植入该装置时，该阀防止由胃向该囊内的回流。
39.权利要求22的装置，其中该囊的远端部分由弹性材料组成。
40.权利要求22的装置，其中该囊由生物可吸收材料组成。
CN201010150945.3A 2001-08-27 2003-02-13 饱满装置和方法 Expired - Fee Related CN101810521B (zh)

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US8568488B2 (en) 2013-10-29
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