CN1713871A - 饱满装置和方法 - Google Patents

饱满装置和方法 Download PDF

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CN1713871A
CN1713871A CNA038132443A CN03813244A CN1713871A CN 1713871 A CN1713871 A CN 1713871A CN A038132443 A CNA038132443 A CN A038132443A CN 03813244 A CN03813244 A CN 03813244A CN 1713871 A CN1713871 A CN 1713871A
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prosthese
capsule
stomach
openings
distal
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CN1713871B (zh
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R·S·斯塔克
R·A·格勒恩
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
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Boston Scientific Scimed Inc
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Synecor LLC
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Priority claimed from PCT/US2003/004449 external-priority patent/WO2003086247A1/en
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Abstract

本发明描述一种饱满装置，它包括自胃近区或胃中部延伸到远端胃窦的管套或套管。患者摄取的食物穿过该管套或套管，由此最大限度地减少摄取食物与胃之间的接触。相信随着时间，食物和胃之间接触的减少导致患者的Ghrelin生成减少，由此降低食欲。在某些实施方式中，所述的饱满装置还可以包括近端囊和/或远端旁路管。

Description

饱满装置和方法
技术领域
本发明一般性涉及实现人体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和/或限制食物摄取的装置的应用。
背景技术
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的gastroplexy或近端胃囊法，其中一部分的近端胃形成小囊并有一个小开口至其余部分的胃。该近端胃囊可以包括Roux-en-Y吻合术，其中一部分的空肠与该囊相连以分流由胃近端区进入肠道的食物，由此最大限度地减少吸收到血流内的食物。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，引起阻塞并因此不得不将其除去。
因此希望提供成功的最小限度介入的方法来代替现有方法达到控制肥胖。
发明概述
采用本发明原理的饱满装置包括位于胃中的管套或套管(Liner)。患者摄取的食物经过该管套或套管，由此最大限度地减少摄入食物与胃之间的接触。相信随着时间的推移，食物与胃接触的减少将导致患者Ghrelin生成的减少并由此降低食欲。在某些实施方式中，该饱满装置还可以包括近端囊和/或远端旁路管。
附图的简要说明
图1是人胃和一部分小肠的示意图。
图2A是饱满装置的第一实施方式的侧视图。
图2B是图2A的实施方式的囊和滑槽的侧视图。
图3是人体胃的示意图，说明图2A的实施方式的体内位置。
图4是人体胃的示意图，说明饱满装置的第二实施方式的体内位置。
图5是人体胃的示意图，说明排放套管的体内位置。
图6类似于图5的示意图，图示具有远端管的排放套管。
图7是类似于图5的示意图，图示具有近端囊的排放套管。
图8是类似于图5的示意图，图示在中间胃/近端胃窦具有近端的排放套管。
图9是人胃和近端小肠的示意图，图示由近端胃延伸到小肠内的旁路管的位置。
图10A表示与图9的囊和管相连的机构的一个实例的截面侧视图。
图10B使表示与图9的囊和管相连的机构的第二实例的截面侧视图。
图11幽门的示意图，表示连接图9的管的近端和远端部分并延伸越过壶腹vader的束带。
发明详述
人体胃S的解剖图及相关特征如图1所示。该食道E将来自口腔的食物传送到胃S。z-线或胃食管接界Z是食管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是指包括食道E的远端部分、z-线和胃S的近端部分在内的区域。
胃S包括位于其近端的基底F和位于其远端的胃窦A。胃窦A进料到与十二指肠D、小肠的近区相连的幽门P中。在幽门P内括约肌防止食物由十二指肠D反流到胃中。位于远离十二指肠D的小肠的中区是空肠J。
Ghrelin是由胃和小肠内的细胞分泌的饱满感激素。Ghrelin的产生增多，例如在饭前，使人有饥饿感。当人进食后，Ghrelin的产生减少。最近发现85％的Ghrelin分泌细胞位于胃内，并且其余15％在胃窦和小肠。人们发现肥胖患者具有明显高于非肥胖患者的Ghrelin水平。此外，最新的研究发现，在胃旁路手术例如上述Roux-en-y手术后患者的Ghrelin生产明显减少。本文所述的许多不同实施方式提供了位于胃中并从胃近区或中部延伸到胃远区或小肠内的排放套管或管套。随着时间推移，排放套管的存在将使Ghrelin分泌细胞减少Ghrelin的生产，导致患者的饥饿水平降低并由此减轻患者的体重。
一些排放套管的实施方式还包括位于胃食管接界区的囊或漏斗，由此形成收集来自食管的咀嚼的食物的小储库。该囊可以限制可同时消耗的食物量。此外或另外，由于囊内填满食物，它可以膨胀，对胃上部和下部食管括约肌产生压力，使患者具有发饱的感觉。随着时间推移，该储库中的食物经囊内的远端开口下降到排放套管。该囊可以选择性地包括可定位在食管内的近端管状延伸部，从而促进食物从食道流向该囊内。适合用于排放套管的不同类型的囊公开在美国专利申请No.10/118,289(2002年4月8日提交)中，其在此引入作为参考用于所有目的。
该装置可以模块化，其中植入多种组件(例如套管和囊)，不同的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机体内，或者其某些组件即使在植入后也仍然保持彼此不相连。另外，医师可以在植入之前即时将组件相互装配在一起。模块组件是理想的，因为它们允许医师针对患者来选择适当大小的各种组件。
上述装置的植入优选利用内窥镜进行，通过使该装置经过食管，优选在内窥镜显形的条件下进行。另外，该装置可以用外科或腹腔镜方法植入。
饱满装置的一个实施方式如图2A所示并且包括位于伸长排放套管14内的囊12。出于本申请的目的，术语“饱满装置”用来表示以一种或多种不同方式诱导体重减轻的装置。这些包括，但不限于，实际限制可消耗食物的量，和/或对机体的某些部位(例如胃，食管，食管括约肌等)产生压力，导致该患者出现发胀的感觉，和/或影响激素或在体内控制或影响饥饿感的其他物质的水平，和/或影响机体吸收的被摄取食物的量。
囊12，如图2B所示无套管，包括带有开口18的漏斗形近端部分16，它可定位在胃食管接界区(并优选低于z-线)，如图3所示。虽然在此优选漏斗形，但许多不同的形状可以用于囊的近端部分。譬如，该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。其他实例包括，但不限于，卵形、其他锥形形状例如“陀螺”的形状，圆柱体形状，和其他对称或不对称形状。
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)，该囊可以起限制可被同时消耗的食物量的作用。随着时间的推移，该储库中的食物经囊内的远端开口下降到排放套管14中。
远端滑槽20延伸自漏斗形近端部分16并包括一个远端开口22。在该实施方式中，该滑槽20自漏斗16向外逐渐变细，在漏斗和滑槽之间形成阀门24。阀门24可以是允许该阀门打开使尺寸增大允许大块食物经过的弹性材料形成的。如果需要，阀门24的直径可以用内窥镜装置调整，例如抽紧阀门四周的结扎线，充满位于该阀门四周的可膨胀束口，或者使用多种其他装置。通过减小出口直径来提高囊的有效性-由此使食物更加缓慢地排出该囊并延长患者的发胀感觉。同样地，可以在内窥镜下通过抽出液体填充的限制束口、使用切割或伸展打开该阀门的工具或者利用多种其他装置增大阀门24的直径，从而提高患者耐受该囊允许该囊更快速排空的能力。
囊12可以由防止食物穿过囊侧的柔性材料构成，此类材料的实例包括，但不限于聚酯(例如Dacron聚酯)，ePTFE织物(例如GoreTex织物或其他)，聚氨酯例如ChronoFlex聚氨酯，尼龙织物，硅氧烷，其他聚合材料，和生物可接受材料(例如PLLA，PGA，PCL，聚amhydride等)。该囊可以由挠性、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。例如，希望提供一个具有相当弹性的出口部分的囊，从而防止活动中关闭大块的被摄取食物和/或控制该囊的食物排放压，而该囊的近端可以更刚性以防止膨胀。通过改变囊的不同区域内囊截面的厚度可以为该囊构建不同程度的挠性。囊材料可以用平滑的、生物相容的、化学惰性材料如paraleyne覆盖，从而减少基底材料表面上的摩擦，这有助于防止粘着和食物堆积在该装置上。
套管14是具有近端开口23和远端开口26的柔性管。该套管材料可以与囊12所述材料相似，但应当足够柔顺以便于蠕动。该套管材料的外部可以用抑制Ghrelin或其他与饱满感有关的激素释放的已知物质浸渍。此类物质可以是化学或药学物质、治疗性分子或细胞，或遗传材料。该套管也可以用抑制胃泌素生成的酸浸渍，或者其外部可以用抗胃泌素抗体浸渍。
套管14和囊12优选在其各自的近端开口18、23处用缝线、夹子、粘合剂或其他适当方式彼此相连。这些组件可以在制造中或仅仅在植入之前相互连接，或者它们可以分开植入。
套管14的近端部分包含多个开口28，其大小允许胃分泌物进入套管14，以帮助穿过囊12的食物消化到套管14内并允许来自胃的分泌物的引流。胃分泌物经套管排出胃并进入幽门。开口28可以是在该套管壁上穿孔或狭槽的形式。另外，在该套管一部分中所述开口可以是网或多孔区内小孔的形式。例如，带有开孔结构的ePTFE是可以装配成允许胃分泌物进入但不允许食物排出的材料。
在图3所示的实施方式中，所述的开口定位使得在当囊12位于所用的套管14内时，使滑槽20的远端开口22优选远离开口28，从而防止食物从套管经开口28排出。开口28也可以位于任何其他位置，特别是如果该开口小到足以防止食物通过时。该开口的其他位置的实例包括位于邻近套管的远端(参见图4)，或基本上沿整个套管的长度方向定位。
套管14的直径足够大到允许该囊附在套管14内，但优选足够窄以使胃内生成的酸流入并接触胃窦壁。相信这种接触是激素胃泌素的正常调节所需要的。胃泌素是胃内胃酸分泌的生理调节剂。增高的胃泌素水平导致胃酸分泌增多。酸水平过高可能导致溃疡。
当胃窦内的细胞探测到低pH时，胃泌素的分泌(并由此导致的胃酸分泌)受到抑制。因此胃内酸与胃窦的接触确保胃泌素的正常调节是重要的。如果不允许酸接触胃窦，胃泌素的生成将提高，并且可由此引起胃酸的产生增加，这可导致胃溃疡。
植入饱满装置例如囊12的方法如美国专利申请No.10/118,289(2002年4月8日)所示和所述。例如，一些公开的方法包括将该饱满装置包装在展开管内，将该管的远端插入胃(优选自食管)中，用推棒经该管射出管内的饱满装置，并且随后用缝线、夹子、粘合剂、径向力、展伸或展伸样结构等固定该饱满装置。此类方法可以用于展开本文所述的饱满装置，包括囊12和套管14。
在植入过程中囊12用缝线、夹子、粘合剂、展伸或展伸样结构，或其他适当方式固定在胃食管接界区G。用于将缝线固定在囊和组织之间的一种缝合连接装置是得自LSI Solutions of Victor，New York的“Sew-Right”缝合装置。
尽管所述的囊可以固定在食管组织，更优选使用缝线/夹子在Z-线下方以便与较厚的胃壁组织相连。缝合附着点，在该囊中采取洞、锚式环、孔眼窗、或扣眼30的形式，在囊中可用来提供固定缝线的区域(可经过加固)。虽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°间隔存在，由此确保该囊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，从而在操作过程之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于缝合的识别和定向。如果该囊由不耐用材料形成，该囊的近端部分(其中孔眼30被定位)可以由更耐用的材料构成，例如织物材料，Dacron聚酯或ePTFE织物，从而得到更坚固的缝合区。虽然环、扣眼、孔眼或加固区可能有利，但也可以提供没有由特殊材料形成的缝合附着点的囊(有或无识别标志)-在这种情况中缝线直接穿过囊材料。
柔性囊和/或套管材料可以用支持体加固、构造或支持，支持体为例如软网、笼结构、肋、环等。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，或由囊材料的增厚区构成。优选所述的囊和/或套管装配而成以便自行扩张，使该囊和/或套管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。
套管14的接近近端开口23的近端可以与囊12单独连接，或其可以连接囊12和周围的组织。套管14在其远端开口与远区胃(例如胃窦处)接近幽门处相连，从而允许食物排出套管14流出胃进入小肠。附着使用缝线、夹子、粘合剂、展伸或展伸样结构，或其他适当方式进行。
图4表示使用囊12a和套管14a的饱满装置10a的另一可选择的实施方式。饱满装置10a不同于图3的实施方式，主要在于囊12a没有远端滑槽(参见滑槽20，图3)，并且其中套管内的开口28a位于该套管的远端，允许胃分泌物引流到套管28a内并由该套管进入幽门。胃分泌物的引流是避免此类分泌物蓄积在胃中所需要的。
套管14a(还及图3的套管14)可以是半不透性的，允许胃分泌物进入但不允许食物排出。具有开孔结构的材料例如ePTFE(例如结节至纤丝，长度为20-100微米)适合此目的。
相信图3和4的实施方式以多种方式引起体重减轻。首先，由于囊填充食物，它可以膨胀，对上部胃和下部食管括约肌产生压力，导致患者在消耗少量食物后出现发胀感。其次，据信利用排放套管14、14a从胃壁分离消耗的食物将导致患者的Ghrelin生成暂时性提高，此后随着时间的推移出现“烧尽”现象，其中Ghrelin减少，反之导致饥饿感减轻。第三，延迟消化且最大限度地减少食物的吸收。
图5-8表示其他实施方式，它们也通过从胃壁分离消耗的食物控制饱满感，以便最终减少患者每日至每日的Ghrelin生成，这归因于上述“烧尽”现象。这些实施方式各自包括一个排放套管，其位于胃内，使消耗的食物穿过该套管且随后排出该套管经幽门流入小肠。
参见图5，第一排放套管32包括位于近区胃，例如位于胃食管接界区G的近端开口34，和一个位于胃窦A内，优选与幽门P相邻的远端开口36。套管32可以成比例地以基本上与胃排成列，同时仍然允许清除胃酸(图5中标记的H+)，以与套管四周的胃窦壁接触-以使防止如上所述的胃泌素过度产生。另外，套管可以根据需要具有足够窄的直径。如图5所示，套管32减少被摄取食物与胃之间的接触，包括与基底和胃窦的接触。
邻近近端开口34的近区优选用缝线、夹子、粘合剂、展伸或展伸样结构或其他适当方式固定在位于Z线下方的胃食管接界区处的组织上。与远端开口相邻的近区以防漏方式固定在远区胃窦，或者可以更加松弛地固定以便允许胃分泌物排出胃进入幽门(参见图5中的箭头)。例如，夹子或缝线等可以采取在远端开口36和幽门之间留下缝隙从而允许胃分泌物引流的方式使用。另外，如果需要这样的引流，套管32可以具有多个开口(参见，例如图4中的开口28a)，它们允许胃分泌物流入套管且随后进入幽门。作为另一种可选择的方式，套管可以由具有回弹支架部件的支架结构支持，回弹支架部件与胃壁接触并防止套管在胃中迁移，但它允许胃壁与套管外部之间的清除。适合此目的的支架结构的类型如美国专利申请09/940,110，(2001年8月27提交)所示和描述。其全文在此引入作为参考。
图6表示排放套管32a，其类似于图5的套管32，但它进一步包含用缝线、锚、夹子、展伸或展伸样结构、粘合剂等固定在幽门或十二指肠的远端管38。另外，这种远端连接可以防漏，从而防止分泌物的引流，或者其可以进行构造以允许这样的引流。
图7表示排放套管32b，其类似于图5的套管，除它包括可附着在胃食管接界区的近端囊40之外。如图3和4的实施方式，当患者进食时囊40被食物填充，导致患者在消耗少量食物后产生发胀的感觉。囊40可以与套管32b整合，或可以在植入之前或之中单独连接。如图5和图6的实施方式，套管32b的远端可以以允许套管外存在的分泌物引流的方式或者以闭合该引流的方式连接在远区胃窦。图7的实施方式还可以具有类似于涂6实施方式的远端管38的远端管。
图8表示从胃中部或胃窦近区成比例延伸到远区胃窦的胃窦排放套管32c。套管32c包括大的近端开口42和较小的远端开口44，如图所示。套管32c的近区固定在胃壁四周，并且远区固定在远区胃窦。套管32c可以以允许一些食物和胃分泌物在套管32c四周流动的方式固定，如图8中箭头所示，或者它可以紧紧固定在胃壁，因此导致所有食物和胃分泌物直接通过套管32c。图8的实施方式可以具有类似于图6的远端管38的远端管。
图5-8的套管可以使用的材料包括防止食物通过囊侧的柔性材料。该材料可以是流体不透性的或者轻度通透的。轻度通透性材料(例如具有20-100微米级别结节至纤丝长度的开孔结构的ePTFE)可能是期望的，其中它们允许胃分泌物通过进入套管但不允许食物排出。
适合该套管的材料的实例包括，但不限于聚酯(例如Dacron聚酯)，ePTFE织物(例如GoreText织物或其他)，聚氨酯例如ChronoFlex聚氨酯，尼龙织物，硅氧烷，其他聚合材料，和生物可吸收材料(例如PLLA，PGA，PCL，聚amhydride等)。该套管可以由挠性、半挠性和/或非挠性材料的复合材料构成，其使套管/囊的不同区域具有不同程度的挠性，以便允许/限制套管/囊延伸到不同位置。例如，可能希望提供一个具有相当弹性的排放储库的套管，从而防止活动中关闭大块的被摄取食物。该材料可以用平滑的、生物相容的、化学惰性材料如paraleyne覆盖，从而减少基底材料的摩擦。
该套管材料的外部可以用抑制Ghrelin或其他与饱满感有关的激素的释放已知物质浸渍。此类物质可以是化学或药学物质、治疗性分子或细胞，或遗传材料。该套管也可以用抑制胃泌素生成的酸浸渍，或者其外部可以用抗胃泌素抗体、或任何的各种治疗药物或分子浸渍。
套管可以通过支持结构加固、构造或支持，所述支持结构的例如软网、圈、支架结构、肋板、环等。该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、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，在硅氧烷套管的情况中，由硅氧烷的增厚区构成。该支持结构可以位于套管材料的内部或外部。可以模制或缝合于套管材料，或者可以用适当粘合剂相连。如果如果使用紧密编织的网或紧密变形的线圈时，可以除去柔性材料。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套管材料的独立内部或外部覆盖物。所述的聚合物可以用减少Ghrelin分泌或中和胃酸性的试剂浸渍。
套管的内径(和/或支持结构)可以用光滑材料例如Teflon或parylene覆盖，以便于食物经该套管穿过。
优选所述的套管构建为能够自行扩张，使该囊在展开装置或导管喷出时径向弹开成为展开状态。在展开套管，例如图5-8的套管的方法的一个实例中，可以将套管压缩并插入展开管。在该实例中，将展开管的远端(优选经过食管)插到胃内并用推棒经过该管射出该管。套管在胃内伸展，并且医师将该套管用缝线、夹子、粘合剂、展伸或展伸样结构径向力等固定在胃上。
图9表示包括伸长的旁路管46的另一饱满装置，它被植入以由近区胃经幽门延伸并进入小肠(例如，穿过小肠的第一个24英寸)。如前述实施方式，管46减少摄取食物与胃之间接触的量并由此可以最终减少Ghrelin的生成。它还发挥类似于Roux-en-y旁路术的作用，其中减少供吸收食物用的小肠表面的量。该管适宜由足够柔顺至允许小肠内蠕动的薄壁聚合物组成。还可以将胆和胰腺管分流，使消化酶插入小肠。
可能希望定位该管，使其不接触vader的壶腹(十二指肠的一个开口，胆汁经过它进入十二指肠)，从而最大限度地减少刺激和choleocystitus的机会。譬如，窄束带50(图11)可以将该管的近端部分52a(它被安置在壶腹vader的近端)连接于该管的远端部分52b，用来避免壶腹阻塞。远端部分52b可以包括漏斗形近端，以便于促进食物在穿过壶腹vader后再进入到管46。
最后，又参见图9，管46可以具有近端囊48，类似于图3的囊，它可以在被摄取的食物填充时膨胀，对上部胃和下部食管括约肌产生压力，导致患者具有发胀感。囊48和管46可以单独植入且随后彼此就地连接。
图10A和10B表示连接囊48和管46的构型的两个实施例。在一个构型中，管48的近端可以插入囊46的远端开口，如图10A所示。另一结构中，囊46的远端可以插入管48的近端，如图10B所示。显然，可以采用其他附着装置，例如缝线、钩子、展伸或展伸样结构和/或粘合剂。
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方式给出而不对本发明的范围构成限定。此外应当理解，已经描述的实施方式的不同特征可以以不同方式组合，从而得到许多附加的实施方式。而且，虽然对用于所公开的实施方式的各种材料、大小、形状、植入位置等进行了描述，但是除了所公开的那些，还可以采用其他方案而不超出本发明的范围。

Claims (55)

1.一种在具有胃、胃窦和幽门的患者中诱导体重减轻的方法，该方法包括下列步骤：
在患者的胃中放置一假体，该假体具有近端开口和远端开口以及位于该近端开口和远端开口之间的通道；
促使该患者摄取食物物质，至少一部分的食物物质穿过近端开口进入该假体；
允许食物物质从该假体排出并流入幽门；和
允许胃的胃分泌物流经至少一部分的该假体周围并进入幽门。
2.权利要求1的方法，其中所述促使和允许步骤减少了胃内表面吸收的食物物质的量。
3.权利要求1的方法，进一步包括多次重复促使和允许步骤的步骤，导致胃的Ghrelin分泌减少并由此减小患者的饥饿感。
4.权利要求1的方法，其中该促使步骤减少被摄取食物物质与胃窦内表面之间的接触。
5.权利要求1的方法，其中该胃包括基底且其中该促使步骤减少被摄取食物物质与基底内表面之间的接触。
6.权利要求1的方法，其中允许胃分泌物流入幽门的步骤包括允许胃分泌物从胃流入该假体。
7.权利要求6的方法，其中该胃分泌物经位于假体近端部分的开口流入假体。
8.权利要求6的方法，其中胃分泌物经该假体的侧壁中的一个或多个开口流入假体。
9.权利要求8的方法，其中一个或多个开口成比例地允许胃分泌物流入该假体，同时基本上阻止被摄取食物物质穿过一个或多个开口。
10.权利要求1的方法，其中至少一部分的胃分泌物流入幽门而不经过该假体。
11.权利要求1的方法，其中该定位步骤包括将该假体的近端部分固定在胃食管接界区内，使该近端开口接收直接来自食管的食物。
12.权利要求11的方法，其中该固定步骤包括将近端部分固定于胃食管接界区的Z-线下方的组织。
13.权利要求1的方法，其中该定位步骤包括将该假体的远端部分固定在胃的远端部分。
14.权利要求1的方法，其中该假体能够自其中该假体具有第一直径的折叠状态扩展为其中假体具有第二、较大直径的展开状态，并且其中该定位步骤包括下列步骤：使该假体为折叠状态，将该假体插入胃内；并且使该假体从折叠状态扩展为展开状态。
15.权利要求14的方法，其中该假体自行扩张为展开状态。
16.权利要求1的方法，其中该假体的近端开口小于远端开口。
17.权利要求1的方法，进一步包括下列步骤：
将管状囊放置在胃的胃食管接界区内，囊包括近端开口和远端开口；
促使患者摄取的食物由食道进入囊的近端开口，并且经过远端开口通过该囊，并进入管状假体。
18.权利要求17的方法，其中该囊的近端开口小于远端开口。
19.权利要求17的方法，其中该囊从囊的近端部分逐渐变细到该囊的更远端的部分。
20.权利要求18的方法，其囊的远端部分包括伸长的滑槽，并且其中该远端开口位于滑槽内。
21.权利要求20的方法，其中单向阀位于滑槽和该囊之间，并且其中该方法包括防止食物物质由滑槽流入囊。
22.权利要求17的方法，其中食物物质进入囊中导致该囊膨胀并对一部分的胃产生压力，使患者经历发胀感。
23.权利要求17的方法，其中该固定步骤包括将囊固定于胃食管接界区的Z-线下方的组织。
24.权利要求17的方法，其中至少一部分的囊处于该假体内。
25.权利要求17的方法，其中该假体自囊的远端部分扩展。
26.权利要求1的方法，其中该定位步骤将假体的近端开口定位在胃基底和幽门之间的位置。
27.权利要求1的方法，其中定位步骤将假体的近端开口放置于邻近食管并将假体的远端开口放置在邻近幽门括约肌。
28.权利要求1的方法，其中该假体包括远端管，并且其中该定位步骤包括将远端管经幽门放置，并且该方法包括促使食物物质自假体穿过进入远端管。
29.权利要求1的方法，其中该远端管包括第一部分、第二部分，并且束带将第一部分和第二部分连接，和其中定位步骤包括放置远端管使束带与壶腹vader相邻。
30.一种诱导患者体重减轻的装置，该装置包括：
一种具有近端开口和远端开口且在该近端开口和远端开口之间的通道的假体，至少一部分的假体可定位在患者的胃内，近端开口成比例以接收至少一部分患者摄取的食物物质，并且远端开口成比例以允许该食物物质从该假体排出且流入幽门，该假体装配为允许胃的胃分泌物流过至少一部分的假体周围并进入幽门。
31.权利要求29的装置，其中该假体包括由防止食物物质从侧壁通过的材料形成的侧壁。
32.权利要求31的装置，其中至少一部分的侧壁是流体可通透的，以允许胃分泌物经过侧壁并进入该假体。
33.权利要求30的装置，其中该假体可位于胃内以允许至少一部分的胃的胃分泌物流入幽门而不经过该假体。
34.权利要求30的装置，进一步包括将假体的近端部分固定在胃食管接界区的固定装置，以便使食物由食道穿过直接进入近端开口。
35.权利要求34的装置，其中该固定装置包括缝线。
36.权利要求34的装置，其中该固定装置包括夹子。
37.权利要求34的装置，其中该固定装置包括粘合剂。
38.权利要求34的装置，其中该固定装置包括可自流线形定位用于插入到胃内而展开成为与胃壁接触的展开状态的结构。
39.权利要求30的装置，进一步包括将假体的远端部分固定在胃内的固定装置。
40.权利要求39的装置，其中该固定装置包括夹子。
41.权利要求39的装置，其中该固定装置包括粘合剂。
42.权利要求39的装置，其中固定装置包括可自流线形定位用于插入到胃内展开成为与胃壁接触的展开状态的结构。
43.权利要求30的装置，进一步包括一个囊，囊包括近端开口和远端开口，囊可定位在胃的胃食管接界区，由此使患者摄取的食物自食道穿过进入囊的近端开口，并且由该囊经过远端开口并进入假体。
44.权利要求43的装置，其中该囊的近端开口小于该囊的远端开口。
45.权利要求的装置44，其中该囊自囊的近端部分逐渐变细到囊的更远端部分。
46.权利要求44的装置，其中该囊的远端部分包括伸长滑槽，并且其中远端开口位于滑槽中。
47.权利要求46的装置，进一步包括位于滑槽和囊之间的单向阀。
48.权利要求43的装置，其中该囊由可伸展材料形成，以便使食物物质进入囊内，导致该囊膨胀并对一部分的胃产生压力，使患者经历发胀感。
49.权利要求43的装置，其中至少一部分的囊位于假体内。
50.权利要求43的装置，其中该假体自囊的远端部分延伸。
51.权利要求30的装置，其中该假体包括一个尾部，其成比例以自胃窦延伸到小肠内。
52.权利要求30的装置，其中该尾部包括一对管子和在管之间延伸的束带。
53.权利要求30的装置，其中该远端开口小于近端开口。
54.权利要求30的装置，其中该假体成比例以减少摄取的食物物质与胃窦内表面之间的接触。
55.权利要求30的装置，其中该假体成比例以减少摄取的食物物质与基底内表面之间的接触。
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CN104114128A (zh) * 2011-12-19 2014-10-22 维斯拉生物医药有限公司 内腔假体和胃肠植入装置

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US7981162B2 (en) 2011-07-19
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US20030040808A1 (en) 2003-02-27
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US7152607B2 (en) 2006-12-26
US20040172141A1 (en) 2004-09-02
US6845776B2 (en) 2005-01-25
CN1713870B (zh) 2010-12-08
US20040138761A1 (en) 2004-07-15
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CN1713871B (zh) 2010-11-24
EP3130320A1 (en) 2017-02-15

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