CN1146367C - 防止胃物向食管回流的医用假体 - Google Patents

防止胃物向食管回流的医用假体 Download PDF

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CN1146367C
CN1146367C CNB96192926XA CN96192926A CN1146367C CN 1146367 C CN1146367 C CN 1146367C CN B96192926X A CNB96192926X A CN B96192926XA CN 96192926 A CN96192926 A CN 96192926A CN 1146367 C CN1146367 C CN 1146367C
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诺曼·戈丁
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Matrix Pharmaceutical Inc
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Abstract

本发明公开的是一个形式为软管、横截面基本一致的假体，该假体的组成部分有：一个可通过内窥镜在食管裂孔疝(3)处缝合或钳夹的环形翼缘(2)，和一段柔软的管形部分(1)，该管形部分可使本体在其外表层受到压力(图中的F)时被挤压变形，以防止胃物回流入食管。食物可自由地通过假体从食管(4)流向胃部(5)。该假体由可为生物接受的聚合物制成，该聚合物亦可含钡硫酸盐，使其能被X光探测到。

Description

防止胃物向食管回流的医用假体
技术领域
本发明涉及阻止胃物回流入食管的医用假体，包括一个由抗胃酸的、可为生物接受的聚合物制成的软管。该管一端系于胃的上部，另一端游离于胃中。
背景技术
此类假体在WO91 01117中有说明，其形状为一有开放通道、可弹性关闭的阀门。通道部分由大渐小收缩，直至软管的下端被封住。但若将其撑开至最大时，该部分基本与系于食管下端之另一部分的宽度相当。根据该说明，此类阀门可以被大于闭合弹力之力打开。这一概念意味着，假体须有一定硬度，在无任何力量将其冲开时可以闭合，而这种力量即为食管对食团所发出的蠕动之力。
这一解决办法却有些不尽人意，因其设想的情形与自然发生的情况相违背，要求由蠕动之力来打开阀门。
在某些情况下，例如当食物未经充分咀嚼即吞下时，食团通过食管需要更大的力量。如果需要更大的力量方能打开阀门的话，则不但有阻塞食物之虞，而且会引起疼痛，或二者兼而有之。
发明内容
本发明的目的在于克服，至少部分克服，上述解决办法的缺陷。
我们发现，有另一种解决办法，虽然乍看上去与前一种解决办法很相似，实则二者大相径庭，它没有上述缺点但可取得相同的结果。这一概念的依据是，用一大小基本一致的简单软管形物将食管延长使其伸入胃中。由于胃的形状相对于食管中轴线是不对称的，若胃物回流，其所产生的压力相对于食管中轴线方向是倾斜的。因此，如果在胃中用一节软管将食管延伸一定长度，在胃物回流时，软管会在斜力的作用下变形迭合，从而阻止胃酸流入食管。
因此，本发明的主题，是防止胃物向食管回流的医用假体，该假体包括一个由抗胃酸的、可为生物接受的聚合物制成的软管，其上端置于胃的上部开口处，其下端在该开口处以下游离于胃腔之中；其特征是具有相当耐力的软管从上端至下端之间部分的直径为25至30毫米，长度为5至10厘米，软管厚度可在0.2mm至0.6mm之间，取决于所使用的聚合物的性质，以便在其外壁受到侧面的压力时，即当胃物回流所产生的压力达到一定的水平时，其可变形迭合；在上端有一稍厚的用于安置的环形翼缘。
除了已提及的优点之外，本发明的医用假体由于其由硬而软的性质，还更容易用内窥镜导入食管；而且，该假体因同样的原因亦更容易被固下下来。前面所提到的阀门通常是闭合的，而与这种阀门相反，本管形假体通常是开放的。因此，作用在安置于食管壁或食管裂孔疝壁上的假体的力量越来越小，事实上作用于该假体上的唯一力量是食物对食管壁产生的极小的力量。
附图说明
图1是装入了本发明的假体的胃和食管的截面图。
图2是图1中假体的截面图。
图3是图2所示假体的变体的截面图。
发明实施方式
图1和图2所示假体是一个简单的由可生物接受的聚合物制成的软管1.还可以考虑其他几种不同的聚合物，如医生硅、医用聚尿烷、聚苯乙烯-乙烯(PSE)或其他弹性体等等，在此不一一列举。
软管的规格可以为例如直径25至30毫米(视假体所依附的食管裂孔疝或食管的直径的不同而不同)，5至10厘米长，其中大部分伸入胃中。管壁的厚度主要取决于所用的聚合物的性质(这种性质还决定了柔软度)，一般约为0.2至0.6毫米。软管必须柔软，但同时又须有一定的耐力，如呕吐时，软管最好能整个翻转过来。这种情况极少出现，一旦出现，则软管的柔软度可借助食管蠕动的压力使其回归原位，或者在必要时可采取内窥镜导入的办法将假体摆正。
如图1所示，胃5内如不断地产生压力，其力量发出的方向为图中箭头F所指的方向，即该力量的方向相对于软管1的长长的中轴线是倾斜的，使得有着柔软管壁的管形假体向胃壁方向变形迭合，从而阻止胃酸从胃里跑出，流向食管的粘膜。
在图1中，管形假体有一个环形翼缘2，用缝合或外斜锁环的办法依附于食管裂孔疝3的底部，食管裂孔疝本身是导致胃物回流的主要因素之一；假体亦可依附于食管4的底部。用金属或尼龙的缝合或锁环办法可以使用合适的内窥镜缝合设备将假体缝合。
制造管形假体1可根据所使用的生物材料，尤其是生物材料的粘性和假体壁的厚度，采用几种不同的工艺。制造这种假体可用注射模塑法、挤压模塑法、或熔化浇铸法(此法即将假体浸入生物材料液中溶化，以取得所需管壁的厚度)。如果用注射模塑法，最好将软管设计为大约有1°或2°的类似锥体的形状，以方便将模取出。
图3所示的变体即为注射的管形假体6，其中一端翼缘较厚，使假体壁在联接处更为牢固。
在图1和图2中，用注射模塑法制成的管形假体有1°的锥削度，以便于卸模。
图3为另一种替代品的例子，其中的管形假体6分为两段，上段6a紧接着起固定作用的环形翼缘7，在本例中其长度为25毫米，锥削度为3°，厚度为0.5毫米；下段(图中的6b)长度为55毫米，锥削度为1°，厚度为0.3毫米。伸入胃腔5中的是下段部分，它在遇更大的胃内压力时会变形迭合。
本医用假体(本专利申请的主题)的作用与WO91 011117所说明的阀门的作用相同，但避免了该阀门的缺点。由于其具有更大的柔软性，本假体的导入和用内窥镜的安置十分方便。

Claims (7)

1.防止胃物向食管回流的假体，本假体包括一个由抗胃酸的、可为生物接受的聚合物制成的软管(1，6)，其上端置于胃(5)的上部开口处，其下端在该开口处以下游离于胃腔之中；其特征是，具有相当耐力的软管(1，6)从上端至下端之间部分的直径为25至30毫米，长度为5至10厘米，软管(1，6)厚度可在0.2mm至0.6mm之间，取决于所使用的聚合物的性质，以便在其外壁受到侧面的压力时，即当胃物回流所产生的压力达到一定的水平时，其可变形迭合，在上端有一个稍厚的用于安置的环形翼缘(2，7)。
2.按权利要求1所述的假体，其特征是，其由医用聚尿烷制成。
3.按权利要求1所述的假体，其特征是，其由医用硅制成。
4.按权利要求1所述的假体，其特征是，其由医用聚苯乙烯-乙烯制成。
5.按权利要求1所述的假体，其特征是，所述软管(1，6)为管形，其上下分为两段，第一段(6a)位于软管的上端，有3°的锥削度，位于下端的第二段(6b)锥削度为1°，下端第二段(6b)的厚度不如上端第一段(6a)。
6.按权利要求5所述的假体，其特征是，第二段(6b)占软管总长度的2/3。
7.按权利要求6所述的假体，其特征是，第二段的厚度为第一段厚度的一半。
CNB96192926XA 1995-03-28 1996-02-28 防止胃物向食管回流的医用假体 Expired - Fee Related CN1146367C (zh)

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WO1996029954A1 (fr) 1996-10-03
AU4632296A (en) 1996-10-16
BR9607908A (pt) 1998-01-13
CA2218417C (fr) 2004-09-21
DE69603264D1 (de) 1999-08-19
AU689369B2 (en) 1998-03-26
EP0817598A1 (fr) 1998-01-14
DE69603264T2 (de) 2000-04-13
ATE182064T1 (de) 1999-07-15
CA2218417A1 (fr) 1996-10-03
US5861036A (en) 1999-01-19
EP0817598B1 (fr) 1999-07-14
JP3258330B2 (ja) 2002-02-18
CH688174A5 (fr) 1997-06-13
ES2135868T3 (es) 1999-11-01
MX9707359A (es) 1997-11-29
CN1179707A (zh) 1998-04-22
JPH10507392A (ja) 1998-07-21
DK0817598T3 (da) 2000-01-24

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