CN1575155A - 饱足装置和方法 - Google Patents

饱足装置和方法 Download PDF

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CN1575155A
CN1575155A CNA028212177A CN02821217A CN1575155A CN 1575155 A CN1575155 A CN 1575155A CN A028212177 A CNA028212177 A CN A028212177A CN 02821217 A CN02821217 A CN 02821217A CN 1575155 A CN1575155 A CN 1575155A
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stomach
prosthese
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CN1307951C (zh
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R·S·斯塔克
R·A·格伦
T·J·穆迪
F·E·西尔弗斯坦
N·埃弗里
W·S·小欧班克斯
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Boston Scientific Scimed Inc
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Abstract

一种用于诱导患者体重下降的装置，包括一个管状假体，该假体能够从具有第一种直径的收缩状态自我扩张到具有第二种较大直径的扩张状态。在一种诱导体重下降的方法中，所述假体是以收缩状态放置的，并且插入患者的胃中。让所述假体从收缩状态自我扩张成扩张状态，并且与胃壁接触，在这里它能诱导产生过饱的感觉和/或抑制调节诸如Ghrelin的过饱控制因子。

Description

饱足装置和方法
技术领域
本发明总体上涉及用于实现人类体重下降的装置和方法的领域，具体地讲，涉及使用可置入人体胃中的装置控制饥饿感。
背景技术
有多种医学方法被用于控制肥胖。这些方法包括饮食、医药和手术方法。比较成功的手术方法之一是通过Roux-en-Y吻合术的垂直捆扎胃丛或近端胃囊。不过，已知上述每一种方法都存在并发症，因此需要更成功的方法。
其他方法包括植入胃气囊，它通过占据胃中的空间，防止吃的过多。不幸的是，胃气囊有可能向下移动到胃肠道中，导致梗阻，因此需要取出。
因此，需要提供一种能替代现有方法的用于控制肥胖的成功的并且伤害较小的方法。
发明内容
一种采用本发明原理的饱足装置，包括一个具有收缩状态的管，该收缩状态的收缩比例适合将所述管导入胃的一部分中。一旦进入体内，所述管就可以自我扩张，与胃的内部接触。在使用期间，摄入胃中的食物从所述管中通过。在另一种实施方案中，所述管可以用能阻止管中的食物与周围的胃壁接触的材料制成。在一种实施方案中，可以将所述管放置在胃窦内。在另一种实施方案中，所述装置可以包括一个胃底吊蓝，它可以与窦管的近端连接或不连接；和/或一个肠管，它可以与窦管的远端连接或不连接。
在另一种实施方案中，将一个小囊与诸如胃底吊蓝的支架结构连接，并且放置在胃的近端。在另一种实施方案中，所提供的所述小囊可以没有支架结构，并且通过内窥镜引导的缝合线或其他方式独立固定在近端胃壁上。
附图说明
图1是人胃和一部分小肠的示意图；
图2是采用本发明原理的饱足装置的平面图；
图3是类似于图2所示饱足装置的平面示意图，但是包括一个药物输送容器；
图4A是胃、幽门和肠子的示意图，表示将图2或3的装置导入胃窦；
图4B是类似于图4A的示意图，表示安装就位的所述装置；
图4C是类似于图4B的示意图，表示将所述装置收入一个鞘中，以便随后从体内取出；
图5是类似于图4B的示意图，表示具有一个窦管和一个肠管的另一种装置的状态；
图6是类似于图4B的示意图，表示具有不穿过幽门括约肌的窦管的另一种装置的状态；
图7是与图6所示窦管类似的窦管的平面示意图，具有设置在外表面上的固定结构；
图8是与图6所示窦管类似的窦管的平面示意图，具有设置在近端和远端的固定结构；
图9A和9B是与图6所示窦管类似的窦管的平面示意图，具有设置在外表面上的不同的固定凸缘；
图10A-10C是具有窦管和胃底吊蓝的饱足装置的透视图；
图10D-10F是具有窦管和肠管的饱足装置的部分侧视图，每一幅图表示窦管的一部分和肠管的一部分；
图11是具有窦管、胃底吊蓝和肠管的饱足装置的平面示意图；
图12A是示意性地表示将图10A-10C所示装置的装置插入体内的平面示意图；
图12B是示意性地表示将诸如图10A-10C所示装置的装置从体内取出的平面示意图；
图13是示意性地表示放入人胃中的饱足装置的另一种实施方案的示意图；
图14是采用线圈结构的饱足装置的侧视图；
图15示意性地表示放入人胃中的图15所示饱足装置的示意图；
图16A和16B是诸如胃底吊蓝，窦管或肠管的饱足装置的管的端视图，示出了可用于方便管的取出的突出部件；
图17A示意性地表示采用一种独立胃囊的另一种饱足装置的体内定位；
图17B是类似于图17A的示意图，不过，进一步示出了与所述胃囊组合的一个支架结构；
图17C是类似于图17B的示意图，不过，进一步示出了与所述胃囊和支架结构组合的排列延伸部分；
图18是可以像在图17A-17C中那样使用的类型的胃囊的透视图；
图19A是可以像在图17A-17C中那样使用的类型的另一种胃囊的透视图；
图19B是图19A所示胃囊的侧剖视图；和
图20表示采用了十二指肠吸收阻隔假体的另一种饱足装置的体内定位。
具体实施方式
在图1中示出了人胃S和相关结构的解剖学示意图。胃S包括位于它的近端的胃底F和位于它的远端的窦A。窦A向幽门P输送食物，幽门与十二指肠D连接，十二指肠是小肠的近端区。在幽门P内具有括约肌，它能阻止食物从十二指肠D回流到胃中。位于十二指肠D远端的小肠的中部是空肠J。
本文披露了饱足装置的各种实施方案。很多这样的装置包括一个可放置在窦A内的窦管，并且，可以选择性地包括一个与所述窦管的近端连接的用于放入胃底F的底管，和/或与所述窦管的远端连接的用于放入十二指肠D中的肠管。
所述装置可以是模块化的，就是说，多个部件是彼此独立提供的。在这种组合系统中，独立置入的部件，可以在植入期间在体内彼此连接在一起，或其中的某些部件即使是在置入之后仍然不是彼此连接的。另外，医生可以在置入之前将这些部件彼此组装在一起。模块化部件的优点在于，它使得医生可以选择适合患者的每一种部件的大小。作为另一种替代方案，所述装置可以是一个整体装置，就是说所述部件(例如窦管，肠管和/或胃底吊蓝)不是独立提供的，而是构成了一个整体置入装置。
图2表示采用本发明原理的饱足装置100的第一种实施方案。饱足装置100包括一个长形管状主体10，它具有一个近端部分12和一个远端部分14。近端部分12包括一个具有较小直径的颈部16。远端部分14优选具有沙漏形状，包括一对较宽的部分18和位于所述较宽部分之间的收缩部分20。
管状主体10是成比例的，使得至少被部分放入胃窦内，以便食物通过管状主体的中空的内部进入胃窦。管状主体10(还可称之为窦管)可以用形状记忆材料制成，如镍钛金属互化物或其他形状记忆合金，或形状记忆聚合物，并且，优选用柔软的网状材料或其他支架材料制成，所述材料是用镍钛金属互化物或不锈钢与聚合物阻隔层组合制成的，所述阻隔层能阻止通过窦管10摄取的食物与窦壁接触。因此，所述聚合物阻隔层可以是设置在所述筛网外部或内部的皮层，或者可以将所述筛网包在聚合材料中，或将所述聚合物放置在筛网的间隙中。在食物从胃的中部到达幽门时，通过阻止食物接触窦壁，该装置能够抑制调节Ghrelin或其他过饱控制因子。
如图3所示，装置100可选择性地包括一个或多个药物输送容器22，容器中装有已知能抑制释放Ghrelin或与过饱的感觉相关的其他激素的已知物质。所述物质可以是化学物质或药物，治疗分子或细胞，或遗传学材料。每一个这样的容器22可以包括一个设置在第一层流体不可渗透的聚合材料和第二层半透膜之间的流体袋，所述半透膜能使所述物质从所述容器进入周围组织中。另外，用于生产所述管的聚合材料可以用能够用于保持低的Ghrelin水平的物质浸泡过的。
含有所述抑制性物质的容器或材料可位于所述装置的处在窦内的部分和/或位于处在十二指肠内的部分，特别是位于靠近小沟壶腹的十二指肠部分，因为据信所述物质的受体存在于该部位。
在置入期间，在放射学导向装置或内窥镜导向装置的引导下，摸索着将窦管10插入患者体内。在置入之前，通过绕纵轴压缩窦管10，并将其插入套管26，优选将窦管10包装在管状套管26中(参见图4A)。
如图4A所示，通过患者的口腔将在内部包装有窦管10的套管26插入胃中，并且放置在胃窦内。然后，利用插入所述管套近端的推出装置28，将窦管10推出套管26的远端。构成窦管的筛网优选制造成能够自我扩张，以便在套管10被弹出套管26时，它能弹性径向张开成扩张状态。在这种扩张状态下，所述窦管产生针对它所接触的内表面的压力，以便产生过饱的感觉，并且抑制Ghrellin释放。所述装置的针对胃壁的径向压力，还将该装置固定在胃窦壁上，并且防止它通过幽门移动，即使在存在蠕动的情况下也是如此。在另一种实施方案中，所述窦部分被覆盖，如通过聚合材料覆盖，以便隔绝来自胃窦的胃中容纳物。这样可以抑制诸如Ghrellin的饥饿感觉的化学介体的产生。
如图4B所示，远端部分14的沙漏形状设计成在置入该装置时，收缩部分20位于幽门括约肌部分处。由于自我扩张的性质，有助于防止该装置在胃中移动，并且能避免堵塞幽门。另外，需要提供在收缩部分20中包括一个阀(未示出)的窦管，以防止胆汁从十二指肠回流到胃窦中。
参见图4C，所述装置的取出是通过以下方法完成的：将套管26插入胃中，并且通过所述套管伸展一个诸如圈套器30的抓握装置。将圈套器30封闭在管10的颈部16周围，并且回拉，导致管10收缩，并且被拖入套管26中。一旦将管10储存在所述套管中，就可将该套管从患者体内拉出。
可以理解的是，可以采用各种其他的机构，以便于所述管的收缩，以便取出。例如，图16A和16B表示另一种窦管11的近端部分端视图，它包括一个或多个径向延伸的突出部分13。突出部分13优选是圆形的和光滑的，以便减弱对通过管11的流动的干扰。在取出所述饱足装置时，使用内窥装置将突出部分13向内拉，导致所述管向内收缩。
参见图5，饱足装置110的另一种实施方案包括一个类似于上述实施方案的窦管10a，还包括一个位于其远端的小直径的肠管32。肠管32优选是用结合图2中的窦管20所披露的组合的筛网和聚合物制成的。它能模仿Roux en Y，或胃肠旁路，这是一种保持食物远离小肠近端部分的方法(即远离十二指肠或空肠和十二指肠，身体吸收的大部分碳水化合物和蛋白是在小肠的这些部分进行的)。它反过来又阻止了小肠的近端部分对食物的吸收，并因此降低了身体所吸收的食物总量。
肠管32的直径小于窦管10a的直径，并且它的直径使它能够轻轻压在小肠的肠壁上。它还必须具有足够的柔韧性，以便向后远远地进入十二指肠的第二部分，而又不会损伤黏膜。这一目的可以通过首先通过内窥镜导入的导线实现。
肠管32可以是用聚合物覆盖的柔软的丝网(例如，用形状记忆合金，镍钛金属互化物，不锈钢合金，不锈钢或包括形状记忆聚合物在内的聚合物制成)，以防食物和消化液体接触十二指肠的黏膜。可以在管32的远端提供一个阀34，该阀起着阻止肠道物质回流的作用。所述肠管包括一个开口33，以确保小沟壶腹不会被堵塞。
正如在前面的实施例中所披露的，插入胃以及从胃中取出装置110可以在放射学或内窥引导下进行。还可以用常规导线实现肠管32的定位。如果使用导线的话，首先使用内窥技术或放射技术将它放入十二指肠，以便引导所述线的定位。然后将肠管32和窦管10a放在所述导线上，并且通过所述导线引导进入十二指肠或空肠，到达预定位点。然后，取出所述导线。小肠管的位置是通过使用推压装置(如图4A所示的推压装置28)压靠在窦管的近端而保持的，同时将覆盖套管拖出。在它们从套管中释放出来的时候，所述小肠管和窦管展开，并且扩张到与胃窦壁接触。
在装置110的模块形式中，窦管10a和肠管32可以单独提供。可以在操作之前将组合系统的部件彼此连接在一起，或者在每一个部件被放入体内之后组装。
如图6所示，可以设计另一种形式的饱足装置120，它具有一个仅仅定位于胃窦内的窦管10b，该窦管不通过幽门括约肌。与前面的实施方案相同，该饱足装置120优选是自我扩张的，并且可以用柔软的镍钛金属互化物，形状记忆聚合物，或不锈钢筛网制成，优选与聚合物组合。
所述窦管和胃壁之间的向外的径向压力，阻止了所述管通过幽门向远处移动，即使在存在蠕动的情况下也是如此。可以提供其他机构，以便阻止所述管朝向胃底和/或幽门移动。例如，如图7所示，可以在窦管10b的外表面上的筛网或聚合物上设置柔软的、定向“鱼鳞”类型的结构36。该附图示出了鱼鳞取向成能防止该装置向幽门移动，但是，应当理解的是，通过使鱼鳞朝向相反的方向，能够防止它朝向胃底移动。
如图8所示，可以在窦管10b的近端和/或远端设置多个钩子38，这些钩子轻轻地连接在胃窦的黏膜上，并且阻止沿近端和/或远端方向的运动。这些钩子应当足够小，以便不会穿透黏膜下层或肌肉层。
图9A和9B表示利用设置在窦管外部的突出部分阻止所述管的移动，所述突出部分能够以多种结构形式形成，如在图9A的实施方案中所示出的螺旋形突出部分40，或在图9B的实施方案中所示出的环42。正如结合图10D-10F所披露的，将同样可以将阻止运动的相同的机构应用于肠管上。
可以从窦管的近端延伸一个吊蓝结构，以便在胃底中定位。参见图10A-10C，胃底吊蓝44a，44b，44c可以用具有大的开口尺寸的筛网制成，以便食物能够通过该胃底吊蓝方便地进入窦管。与窦管的筛网不同，胃底吊蓝的筛网优选不用聚合物皮层或涂层覆盖。胃底吊蓝与窦管是机械连接的，例如，通过弹簧部件46a(图10A)，长形支柱46b(图10B)，筛网46c(图10C)或等同的结构部件连接。胃底吊蓝的近端放置在胃底壁上，因此起着阻止该装置在胃内移动的作用。采用窦管和胃底吊蓝的实施方案，能够以模块化形式提供——其中，窦管和胃底部件是彼此独立的，然后在操作之前或者在置入体内之后再连接在一起。另外，所述窦管和胃底吊蓝可以构成一个整体装置。
在具有所述部件的实施方案中，无论是否使用胃底吊蓝，可以用类似的连接机构将肠管连接在窦管上。例如，如图10E和10F所示，可以用一个或多个纵向撑杆将肠管部分132b和窦管部分110b连接在一起。另一种实施方案可以不提供纵向撑杆，在这种情况下，肠管132a和窦管110a可以分别放置，并且在它的近端边缘可以包括一个颈部133(或突出部分，如图16A/16B的突出部分13)，以便能够通过内窥镜控制的圈套器进行回收，参见图10D。正如上文所讨论过的，这种类型的装置能够以组合形式或一体化装置形式提供。
参见图11，具有窦管10b和胃底吊蓝44的实施方案还可以包括一个与窦管连接的肠管32。正如前面结合图5所披露的，肠管32起着阻止食物接触近端小肠的作用。肠管32可能具有类似于结合图5所述实施方案所披露的性能。
与前面的实施方案相同，图10A-10F和11所示的实施方案优选以收缩状态插入胃中，例如，像在图12A中所示出的那样收藏在套管26中。对于仅包括窦管和胃底管的如图10A-10C所示的实施方案来说，窦管的远端被放置在幽门中(或如图2的实施方案所示穿过幽门)，并且将套管拉出。当它们被释放出来的时候，窦管和胃底装置自我扩张，并且会略微缩短。
如图10D-10F所示，如果包括一个小肠管的话，该管可以像在结合图5所做的说明那样，在放射学引导或内窥镜引导下或通过导线放置。正如所披露的，窦管、胃底吊蓝，和肠管可以构成整体装置的各个部分，或者它们可以作为模块化部件单独提供。在模块化装置中，上述三种部件中的每一种可以分别提供，然后在置入之前或者在将每一个部件放置到体内之后彼此连接。在另一种形式的模块化装置中，所述部件中的某些而不是全部(例如，胃底吊蓝和窦管，或窦管和肠管)可以构成一个整体装置，并且提供另外一个组合部件，以便随后在置入之前或之后与所述整体装置连接。
参见图12B，无论它是仅包括窦管，胃底管和窦管，还是包括胃底管、窦管和小肠管，所述装置的取出都是通过以下方式进行的：将一个套管26插入胃中，通过该套管插入一个抓握装置，抓住该装置的近端，并且将所述管拉入所述套管中，使它收缩。如果将金属丝圈套器环用作抓握装置的话，将该圈套器放置在一个颈部周围(如图2所示的颈部16或图12B所示的位于胃底吊蓝近端的内置的颈部17)，以便抓住所述装置。与圈套器环的接合，有助于当圈套在所述颈部周围收紧时，使所述管收缩，并且被拉入套管26中。另外，如结合图16A和16B所披露的，所述管的近端可以包括突出部分13，它是使用内窥装置径向向内拉动的，以便有助于所述装置的收缩。
在图13中示出了另一种饱足装置130。与前面所述的装置相同，装置130包括一个可放置在胃窦内的窦管10c，以便减少进入胃窦的食物和胃窦壁之间的直接接触。窦管10c可以用组合的柔软聚合材料以及用镍钛金属互化物，不锈钢和/或聚合物制成的强化部件制成。在图13所示实施方案中，装置130是用聚合物套管48制成的，它具有包埋在套管材料中的镍钛金属互化物撑杆50。不锈钢或聚合物强化条带52沿着管状部件的内壁纵向分布。将用柔软的弹性聚合物制成的可充气的容器54放置在管状套管48的外部。填充管56与该容器形成流体连接。在将该装置放入胃窦之后，用盐水填充容器54，以便扩张套管48，使它与胃窦壁接触，以便将该装置在胃窦内的固定到位。在用盐水填充之后，填充管56可以与所述容器分离。为了防止盐水泄露，可以在该容器内部的填充管连接点上安装一个单向阀(未示出)。
在图14和15中示出了饱足装置200的另一种实施方案。该装置可以用线圈状金属丝部件制成，以便形成一个扩张形状的装置。所述线圈的轮廓可以与内部腔壁的轮廓吻合，如用形状记忆材料，如镍钛金属互化物或聚合物制成所述线圈，并且将所述材料定型成需要的形状。装置200具有可放入胃窦内的近端部分202，以及一个可以放置在十二指肠球中或进一步放入小肠中的远端部分204。线圈的节距是经过选择的，以便使装置200具有需要的强度和弹性。
由一个平直部分206连接近端部分202和远端部分204。平直部分206可以放入幽门括约肌内。在正常情况下，幽门括约肌保持闭合状态，直到胃准备将其中的内含物排入十二指肠。平直部分206的优点是，它提供了连接近端部分202和远端部分204的结构，同时使得幽门括约肌能够正确发挥其正常功能。
尽管用于装置200的优选材料是金属丝，但是，应当指出的是，可以将多种替代材料用于这一目的。例如，装置200可以用材料条制成，或者它可以用金属片材制成，或者它的形状可以通过从管材成形加工中切割形成。
在图17A中示出了饱足装置300的另一种实施方案。装置300包括一个管状囊302，将它放入胃的近端区。如图所示，囊302包括一个优选被放置在略微靠近胃-食道结合部分的近端。所述囊的囊壁优选沿从近端向远端的方向向内收缩。例如，在其近端具有一个直径大约为25-50毫米的近端开口304，并且在远端形成一个直径大约为6-12毫米的远端开口308。优选将近端开口304放置成与食道对齐，并且使远端开口308通向胃的内部。
由于所述囊的体积较小(它的体积可以在大约30-50cc的范围内)，它起着限制一次可以消耗的食物数量的作用。由患者摄取的食物停留在所述囊中，直到消化酶对它进行了充分的降解，使它能够通过远端开口308流出。
所述囊优选是自我膨胀的，并且可以采用多种形式。例如，参见图18，它可以用支柱310或由镍钛金属互化物、不锈钢、聚合物(包括形状记忆聚合物)制成的筛网制成。将一个环312与所述装置近端的撑杆/筛网连接，并且同样可以用镍钛金属互化物、不锈钢、聚合物(包括形状记忆聚合物)制成。所述囊的外部或内部用材料313覆盖，以便阻止食物通过所述囊的侧壁。所述材料的一种例子是聚酯材料，如由杜邦公司以Dacron为商标出售的聚酯。
图19A和19B表示囊302a的另一种例子。囊302a是由形状记忆线圈制成的，所述线圈业已被热定型成漏斗形状。可选择性地用Dacron聚酯或其他材料313a(图19B)覆盖所述线圈的内壁或外壁，不过，所述线圈本身可能小到足以阻止食物进入周围的胃壁。如图19B所示，可以将材料313a夹在最近的线圈312a以及相邻的线圈之间。
囊302，302a可以具有相当长的从近端至远端的尺寸(例如，大约2.5-5.0厘米)，并因此使所述囊具有图18-19A所示的漏斗形状。不过，所述囊可以采用多种其他形状。例如，所述囊可以具有更短的近端至远端的尺寸，并因此具有在其底表面上具有一个小孔的茶碟形状。
所述胃囊可以单独使用，或者与其他部件组合使用。如果是在没有其他部件的情况下使用的话，所述囊的近端(例如，囊302的环312或囊302a的环312a)可以起着缝合环的作用，它是通过缝合线连接在胃的内壁上的。所述缝合线可以穿过材料313，313a(参见图19B)以便加固胃壁和所述装置之间的连接。另外，所述囊可以作为没有缝合线的独立装置使用——在这种情况下，可以通过撑杆、筛网或线圈的径向扩张力固定到位。
另外，所述胃囊可以是较大的饱足装置的一部分。例如，参见图17B，所述囊的近端部分(如图18所示的囊的环312或图19A所示的囊的上部线圈312a)可以与一个较大支架结构314的近端连接。支架结构314从食道延伸到胃窦的近端部分，并且可以类似于上述胃底吊蓝。它可以是大的扩张状结构，优选是用自我扩张材料制成，如不锈钢或形状记忆材料，如镍钛金属互化物或聚合物。支架结构314主要起着扩张胃的作用，以便产生过饱的感觉。如图所示，将囊300悬挂在支架结构314的内部。
另外，所述囊(在有或没有支架结构314的条件下使用)还可以通过它的近端与一个对齐的延伸部分316连接。参见图17C，对齐的延伸部分316是一个伸入食道中的管状扩张部分。在一种实施方案中，延伸部分316的长度可能接近5厘米，它主要起着保持所述囊的近端开口与食道对齐的作用-以便通过食道的食物能够方便地进入所述囊中。
最后，可以从所述囊的远端开口延伸一个封闭的旁路尾巴(未示出)，通过幽门进入小肠，以便模拟胃的旁路过程。所述尾部的结构可以类似于结合图5所披露的肠管。
可以采用结合上述实施方案所披露的方法置入和取出所述胃囊和相关部件。在所述胃囊包括支架结构，对齐的延伸部分，和/或旁路尾部的实施方案中，这些部件可以作为一个装置同时置入，另外，还可以将它们分别置入，并且在将它们放入体内之后再进行缝合连接。
在图20中示出了饱足装置的另一种实施方案。该饱足装置包括一个十二指肠吸收阻隔装置——一个长形管400，可将它放入小肠内位于偏向小沟壶腹远端的部位。例如，可以将所述阻隔装置放置在距离小沟壶腹大约1厘米或1厘米以上的距离的位置。理想的是对所述管进行定位使它不接触壶腹(胆汁通过它进入十二指肠的一个开口)，以便减少刺激胆囊和Choleocystitus的机会。
管400优选是一个柔性管，其长度优选大约20厘米或更长。可以按照制造上述饱足装置的方法制造管400。例如，它可以用自我扩张的材料制成，如镍钛金属互化物、不锈钢或形状记忆聚合物(例如寡聚-(己内酯)-二甲丙烯酸酯或n-丙烯酸丁酯)，并且用一种聚合物覆盖层覆盖，该覆盖层(例如硅氧烷)能抗胃液腐蚀，并且能阻止食物副产品通过所述管壁。
管400通过阻止十二指肠壁吸收食物，抑制小肠内的热量获取，并因此起着帮助减肥的作用。
可以采用上述技术放入并且取出管400，并且可以通过本文所披露的任何方式对它进行固定，包括缝合线，倒钩，鳞片，钩子，或者通过扩张装置作用于周围的十二指肠壁上的向外压力固定。管400可以单独使用，或者与上述类型的部件组合使用。
业已对饱足装置的各种实施方案进行了说明。这些实施方案是以举例形式提供的，而不是要限制本发明的范围。不过，应当理解的是，业已披露的所述实施方案的各种特征能够以各种方式组合，以便产生多种其他的实施方案。

Claims (110)

1.一种诱导患者体重下降的方法，包括以下步骤：
提供一个管状假体，该假体能够从具有第一种直径的收缩状态扩张成具有第二种较大直径的扩张状态；
当所述假体处在收缩状态时，将它插入患者的胃中；和
让所述假体从收缩状态自我扩张成扩张状态，并且与胃壁接触。
2.如权利要求1的方法，其中，所述插入步骤包括将所述假体插入胃窦中，并且，所述让假体自我扩张的步骤导致所述假体自我扩张到与胃窦壁接触。
3.如权利要求2的方法，其中，所述假体包括一个收缩部分，并且，所述方法包括使得所述收缩部分位于胃的幽门括约肌处。
4.如权利要求1的方法，其中，所述假体和胃壁之间的接触将所述假体在胃中固定到位。
5.如权利要求1的方法，其中，所述假体和胃壁之间的接触导致患者产生饱足的感觉。
6.如权利要求5的方法，其中，所述假体和胃壁之间的接触，抑制了饿感觉的化学介体在所述患者体内产生。
7.如权利要求6的方法，其中，所述化学介体包括Ghrelin。
8.如权利要求1的方法，其中，所述假体包括与一个流体不可渗透的阻隔层组合的自我扩张的支架，所述流体不可渗透的阻隔层能阻止食物材料通过假体的壁运动和进入胃中。
9.如权利要求1的方法，其中，所述假体包括装有过饱控制物质的流体可渗透的容器，并且，所述方法包括让所述过饱控制物质通过流体可渗透的容器进入胃中。
10.如权利要求1的方法，其中，所述假体包括用过饱控制物质浸泡过的膜，并且，所述方法包括让所述过饱控制物质通过流体可渗透的容器进入胃中。
11.如权利要求1的方法，其中，所述假体是用形状记忆材料制成的。
12.如权利要求11的方法，其中，所述形状记忆材料是镍钛金属互化物。
13.如权利要求12的方法，其中，所述形状记忆材料是形状记忆聚合物。
14.如权利要求1的方法，其中，所述假体是用筛网制成的。
15.如权利要求2的方法，其中，所述假体包括一个位于所述收缩部分的阀，并且，所述方法包括用所述阀阻止胆汁从十二指肠回流到胃窦中。
16.如权利要求1的方法，其中，所述假体包括一个近端，并且，所述方法包括以下步骤：将一个圈套器插入胃中，使所述圈套器套在所述近端上，并且抽出所述圈套器，以便使所述假体收缩。
17.如权利要求16的方法，还包括进一步抽出所述圈套器，以便将所述假体从胃中取出的步骤。
18.如权利要求1的方法，其中，所述插入步骤包括以下步骤：将所述假体放入一个长形套管中，并且将所述长形套管插入胃中，并且，所述让假体自我扩张的步骤包括将所述套管从假体中抽出。
19.一种实现患者体重下降的方法，包括以下步骤：提供一个包括一个窦管的假体，该窦管能够从具有第一种直径的收缩状态扩张到具有第二种较大直径的扩张状态；
另外，提供了可与所述窦管远端部分连接的肠管，所述肠管的直径小于窦管的第二种直径；
当所述窦管处在收缩状态时，将其插入患者胃窦；
让所述窦管从收缩状态自我扩张成扩张状态，并且与胃窦壁接触；
将所述肠管与所述窦管连接；和
将所述肠管放入所述患者肠道中。
20.如权利要求19的方法，其中，所述连接步骤是在插入步骤之前进行的。
21.如权利要求19的方法，其中，所述连接步骤是在插入步骤之后进行的。
22.如权利要求19的方法，包括使得由患者摄取的食物通过所述窦管和肠管的步骤。
23.如权利要求23的方法，其中，所述使得食物通过肠管的步骤包括阻止食物与肠管周围的肠道接触。
24.如权利要求19的方法，其中，所述窦管包括一个收缩部分，并且，所述方法包括将所述收缩部分放置在胃的幽门括约肌处。
25.如权利要求19的方法，其中，所述窦管和胃壁之间的接触将窦管在胃中固定到位。
26.如权利要求19的方法，其中，所述窦管和胃壁之间的接触导致患者产生饱足的感觉。
27.如权利要求26的方法，其中，所述假体和胃壁之间的接触抑制了饥饿感觉的化学介体在患者体内的产生。
28.如权利要求27的方法，其中，所述化学介体包括Ghrelin。
29.如权利要求1的方法，其中，所述窦管是用形状记忆材料制成的。
30.如权利要求29的方法，其中，所述形状记忆材料是镍钛金属互化物。
31.如权利要求29的方法，其中，所述形状记忆材料是形状记忆聚合物。
32.如权利要求19的方法，其中，所述窦管是用筛网制成的。
33.如权利要求24的方法，其中，所述窦管包括一个位于所述收缩部分的阀，并且，所述方法包括利用所述阀抑制胆汁从十二指肠回流到胃窦中。
34.如权利要求19的方法，其中，所述窦管包括一个近端，并且，所述方法包括以下步骤：将一个圈套器插入胃中，将所述圈套器放置在所述近端周围，并且抽出所述圈套器，以便使所述窦管收缩。
35.如权利要求34的方法，还包括进一步抽出所述圈套器以便将收缩的窦管从胃中取出的步骤。
36.如权利要求19的方法，其中，所述插入步骤包括以下步骤：将所述窦管放入一个长形套管中，并且将所述套管插入胃中，并且，所述让窦管自我扩张的步骤包括将所述长形套管从窦管中抽出，使得窦管弹开成扩张状态。
37.一种实现患者体重下降的方法，包括以下步骤：
提供一个包括一个窦管的假体，该窦管能够从具有第一种直径的收缩状态扩张到具有第二种较大直径的扩张状态；
另外，提供了一个可以与所述窦管的近端连接的胃底吊蓝；
当所述窦管处在收缩状态时，将其插入患者胃窦中；
让所述窦管从收缩状态自我扩张成扩张状态，并且与胃窦壁接触；
将所述胃底吊蓝与所述窦管连接；和
将所述胃底吊蓝放入所述胃底。
38.如权利要求37的方法，其中，所述连接步骤是在插入步骤之前进行的，其中，所述胃底吊蓝包括一种收缩状态和一种扩张状态，并且，所述将胃底吊蓝放入胃底的步骤包括在收缩状态下将胃底吊蓝和窦管插入胃中，并且让所述胃底吊蓝和窦管自我扩张成它们的扩张状态。
39.如权利要求37的方法，其中，所述连接步骤是在插入步骤之后进行的。
40.如权利要求37的方法，包括使患者摄取的食物通过所述胃底吊蓝和窦管的步骤。
41.如权利要求37的方法，其中，所述假体和胃壁之间的接触将所述假体在胃中固定到位。
42.如权利要求37的方法，其中，所述窦管和胃壁之间的接触导致患者产生饱足的感觉。
43.如权利要求42的方法，其中，所述假体和胃壁之间的接触抑制了饥饿感觉的化学介体在患者体内的产生。
44.如权利要求43的方法，其中，所述化学介体包括Ghrelin。
45.如权利要求37的方法，其中，所述窦管是用形状记忆材料制成的。
46.如权利要求45的方法，其中，所述形状记忆材料是镍钛金属互化物。
47.如权利要求45的方法，其中，所述形状记忆材料是形状记忆聚合物。
48.如权利要求37的方法，其中，所述窦管是用筛网制成的。
49.如权利要求37的方法，其中，所述胃底吊蓝包括一个近端，并且，所述方法包括以下步骤：将一个圈套器插入胃中，将所述圈套器放置在所述近端周围，并且抽出所述圈套器，以便使胃底吊蓝和窦管收缩。
50.如权利要求49的方法，还包括进一步抽出所述圈套器以便将收缩的胃底吊蓝和窦管从胃中取出的步骤。
51.如权利要求37的方法，其中，所述插入步骤包括以下步骤：将所述胃底吊蓝放入一个长形套管中，并且，将所述长形套管插入胃中，并且，所述使胃底吊蓝和窦管自我扩张的步骤包括将长形套管从胃底管中抽出。
52.如权利要求38的方法，其中，所述插入步骤包括以下步骤：将所述胃底吊蓝和窦管放入长形套管中，并且将所述长形套管插入胃中，并且，所述让胃底吊蓝和窦管自我扩张的步骤包括将所述长形套管从胃底吊蓝和窦管中抽出。
53.如权利要求37的方法，还包括以下步骤：将一个长管连接在所述窦管的远端；和
将所述长管放入患者的肠道中。
54.如权利要求53的方法，其中，连接所述肠管的步骤是在将窦管插入患者胃窦的步骤之前进行的。
55.如权利要求53的方法，其中，连接所述肠管的步骤是在将窦管插入患者胃窦的步骤之后进行的。
56.如权利要求53的方法，还包括使得患者摄取的食物通过胃底吊蓝、窦管和肠管的步骤。
57.一种用于诱导患者体重下降的装置，包括：
一个适合放入胃中的假体，所述假体形成了一个供食物通过的腔体，所述假体能从收缩状态自我扩张成扩张状态，所述假体还包括
适合放入胃窦中的窦状部分，以便所述窦状部分的外壁接触相邻的胃壁，
一个其大小适合放入十二指肠中的肠道部分，以便所述肠道部分的外壁接触相邻的十二指肠壁，和
一个介于所述窦状部分和肠道部分之间的中间部分，用于放入胃的幽门括约肌处。
58.如权利要求57的装置，其中，所述假体是用自我扩张的筛网制成的。
59.如权利要求58的装置，其中，所述筛网是用不锈钢制成的。
60.如权利要求58的装置，其中，所述筛网是用形状记忆材料制成的。
61.如权利要求60的装置，其中，所述筛网是用镍钛金属互化物制成的。
62.如权利要求57的装置，其中，所述假体是用形状记忆聚合物制成的。
63.如权利要求58的装置，其中，所述假体包括位于窦管部分的流体不可渗透的阻隔层。
63.如权利要求57的装置，其中，所述窦管部分和肠部分是用金属丝线圈制成的，并且，所述中间部分包括一个分布在所述窦管部分和肠部分之间的长形部件。
64.如权利要求63的装置，其中，所述长形部件是金属丝。
65.如权利要求63的装置，其中，所述长形部件是带状物。
66.如权利要求63的装置，其中，所述长形部件是缝合线。
67.一种用于诱导患者体重下降的方法，包括以下步骤：
提供一个具有近端开口和远端开口的囊；
将所述囊放入患者的胃中；
将所述囊的近端开口放置在食道的远端，并且大体上将所述近端开口与所述远端对齐；
将所述囊固定在胃中；和
让由患者摄取的食物从食道流入所述囊。
68.如权利要求67的方法，其中，所述近端开口的直径大于远端开口的直径。
69.如权利要求68的方法，其中，所述囊具有接近漏斗的形状。
70.如权利要求67的方法，还包括以下步骤：
将所述囊连接在一个支架结构上；
将所述支架放入胃中。
71.如权利要求70的方法，其中，所述连接囊和支架结构的步骤是在将支架结构放入胃中的步骤之后进行的。
72.如权利要求70的方法，其中，所述连接囊和支架结构的步骤是在将支架结构放入胃中的步骤之前进行的。
73.如权利要求70的方法，其中，所述将支架结构放入胃中的步骤包括将支架结构的一部分放置在胃底部。
74.如权利要求67的方法，包括将对齐管放置在患者食道的远端部分的步骤，所述对齐管将食物从食道引导至所述囊的近端开口。
75.一种用于诱导患者体重下降的装置，该装置包括：
一个具有近端开口和远端开口的管状囊，所述囊是成比例的，以便当所述近端开口位于患者食道的远端时，所述远端开口进入胃的近端区，这样，来自食道的食物直接进入所述近端开口，通过所述囊，然后进入胃的近端区，所述囊是成比例的使得限制食物流动，以便食物能够以比在没有所述囊的情况下食物从食道进入胃中的速度更慢的速度，从所述囊进入胃中。
76.如权利要求75的装置，其中，所述近端开口的直径大于远端开口的直径。
77.如权利要求75的装置，其中，所述囊具有接近漏斗的形状。
78.如权利要求75的装置，其中，所述囊能够从收缩状态自我扩张成扩张状态。
79.如权利要求78的装置，其中，所述囊是用形状记忆材料制成的。
80.如权利要求79的装置，其中，所述形状记忆材料是镍钛金属互化物。
81.如权利要求79的装置，其中，所述形状记忆材料是形状记忆聚合物。
82.如权利要求75的装置，其中，所述囊是用线圈制成的。
83.如权利要求75的装置，其中，所述囊是用筛网制成的。
84.如权利要求75的装置，其中，所述囊包括位于所述近端开口的缝合环。
85.如权利要求75的装置，还包括一个可放入胃的近端区的支架结构，所述囊可以与所述支架结构的近端部分连接，以便所述远端开口延伸到所述支架结构的内部。
86.如权利要求75的装置，还包括一个可放入食道的远端区的对齐管，所述对齐管包括一个可以与所述囊的近端连接的远端。
87.如权利要求86的装置，还包括一个可放入胃的近端区的支架结构，所述囊可以与所述支架结构的近端部分连接，以便所述远端开口延伸到所述支架结构的内部。
88.一种用于诱导患者体重下降的方法，包括以下步骤：
提供一个长形管；
将所述管固定在患者肠道中，远离小沟壶腹；和
让食物进入患者的肠道，通过所述管，所述管形成了阻止肠道吸收食物的阻隔层。
89.如权利要求88的方法，其中，所述管是用覆盖有聚合物阻隔层的形状记忆支架制成的。
90.如权利要求89的方法，其中，所述形状记忆支架是用镍钛金属互化物制成的。
91.如权利要求90的方法，其中，所述形状记忆支架是用形状记忆聚合物制成的。
92.一种诱导患者体重下降的方法，包括以下步骤：
提供一个具有环绕一个腔体的壁的管状假体，所述壁构成了一个支架结构，该结构能够从假体具有第一种直径的收缩状态自我扩张成所述假体具有的第二种、较大直径的扩张状态；
当所述假体处在收缩状态时，将其插入患者的胃中；和
让所述假体从收缩状态自我扩张成扩张状态，并且接触胃壁。
93.如权利要求92的方法，其中，所述插入步骤包括将所述假体插入胃窦中，并且，所述让假体自我扩张的步骤使得假体自我扩张到与窦壁接触。
94.如权利要求93的方法，其中，所述假体包括一个收缩部分，并且，所述方法包括使所述收缩部分位于胃的幽门括约肌处。
95.如权利要求92的方法，其中，所述假体和胃壁之间的接触将所述假体在胃中固定到位。
96.如权利要求92的方法，其中，所述假体和胃壁之间的接触导致患者产生饱足的感觉。
97.如权利要求96的方法，其中，所述假体和胃壁之间的接触能抑制饥饿感觉的化学介体在患者体内产生。
98.如权利要求97的方法，其中，所述化学介体包括Ghrolin。
99.如权利要求93的方法，其中，所述壁包括与流体不可渗透的阻隔层组合的自我扩张的支架结构，所述流体不可渗透的阻隔层能阻止食物材料从所述腔体中通过所述壁进入胃中。
100.如权利要求92的方法，其中，所述假体包括一个装有过饱
101.如权利要求92的方法，其中，所述假体包括用过饱控制物质浸泡过的膜，并且，所述方法包括让所述过饱控制物质透过所述膜进入胃中。
102.如权利要求92的方法，其中，所述壁是用形状记忆材料制成的。
103.如权利要求102的方法，其中，所述形状记忆材料是镍钛金属互化物。
104.如权利要求103的方法，其中，所述形状记忆材料是形状记忆聚合物。
105.如权利要求92的方法，其中，所述壁是用筛网制成的。
106.如权利要求93的方法，其中，所述假体包括一个位于所述收缩部分的阀，并且，所述方法包括利用所述阀防止胆汁从十二指肠回流到所述窦中。
107.如权利要求92的方法，其中，所述假体包括一个近端，并且，所述方法包括以下步骤：将一个圈套器插入胃中，将所述圈套器放置在所述近端周围，并且抽出所述圈套器，以便使所述假体收缩。
108.如权利要求107的方法，还包括进一步抽出所述圈套器以便将所述假体从胃中取出的步骤。
109.如权利要求92的方法，其中，所述插入步骤包括以下步骤：将所述假体放入一个长形套管中，并且将所述长形套管插入胃中，并且，所述让假体自我扩张的步骤包括将所述长形套管从所述假体中抽出。
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