CN1080184C - 医用软管的取向挤出方法 - Google Patents
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Abstract
本发明提供一种制作柔性医用软管(32)的方法，它包括下列步骤：提供一种聚合材料，从该聚合材料成形软管，所得软管(32)具有纵向轴线和一定初始直径，以及沿软管(32)的纵向轴线对软管进行取向，使软管(32)的直径缩小到规定的取向直径。
Description
技术领域
本发明涉及一种制作医用软管的方法，更具体地说涉及一种沿软管的纵向轴线使软管取向的方法。
背景技术
在医疗领域，有各种医疗试剂被收集、加工和储存在容器中，运输并最终经过管子注入到患者身体中，近来人们趋于开发旨在克服目前所使用的诸如聚氯乙烯之类材料存在的种种缺点，用于制作这类容器及软管的材料。这类用于软管的新材料必须具有各项性能的独特组合，以便使软管能应用于液体给药装置并与医疗注入泵配合使用。这些性能包括，材料必须是光学透明的、环境兼容的，具有足够的屈服强度及柔软性，含有尽量少的低分子量添加剂，并且与各种医用溶液相容。
希望医用软管为光学透明的，以便可以用肉眼检查管内的液体。超声波也必须能够穿透软管，因为与注入泵相联的传感器一般都采用超声波来探测例如管内的气泡等异常情况。
还要求软管为环境兼容的，因为有大量的医用软管要通过埋藏或焚烧处理掉。就埋藏处理的软管而言，希望用尽量少的材料来制作软管。而使用一种可以用热塑化方式循环再用的材料则更好，因为这样在制作期间产生的边角料就可加入到新鲜原料中并重新制作成其他有用的制品。
对于通过焚烧处理掉的软管，其使用的材料不得或极少产生诸如可能对环境有害、刺激性及腐蚀性的无机酸之类的副产物。例如，聚氯乙烯(PVC)在焚烧时会产生有害数量的氯化氢(或接触水时变成的盐酸)，致使焚烧炉被腐蚀并可能对环境造成污染。
要做到与医用溶液相容，就希望软管材料不含或含极少的低分子量添加剂，例如增塑剂、稳定剂等。这类成分有可能被与该材料相接触的治疗溶液所提取。于是这类添加剂要么与治疗试剂发生反应，要么使其溶液失效。这在生物技术药物制剂中尤其麻烦，在这种情况下药物的浓度是以百万分率(ppm)来计量，而不是以重量或体积百分数计量的即使损失极少量生物技术药物就可能导致整个制剂不能使用。因为生物技术制剂每份剂量就可能价值数千美元，故务求保持剂量不发生改变。
聚氯乙烯(“PVC”)由于能满足大部分上述要求而一直被广泛用于制作医用软管。PVC软管为光学透明的，允许用肉眼检查流经管内的液体。已证明PVC软管在泵压给药装置中工作得很好。PVC医用软管还具有满意的应力-应变特性，故这种材料允许沿软管纵向轴线取向而不引起软管直径缩小。换句话说，PVC软管抗缩颈。PVC医用软管还具有有利的表面特性，允许使用滑动夹子夹住管壁以停止或减少经过管子的液体流动，以此来控制通过软管的液体流率。可以使用滑动夹子而又不会划伤或夹断软管。
由于PVC本身是刚性聚合物，故必须加入称为增塑剂的低分子量成分才能使PVC变得柔软。前面已经提到，这类增塑剂可能被液体从软管中提取出来。鉴于这一原因以及在焚烧PVC的过程中所遇到的种种难题，故需要设法替代PVC医用软管。
已开发出满足医用容器及软管的多项要求并克服了与PVC相关联的种种缺点的聚烯烃及聚烯烃合金。聚烯烃由于向液体的提取性极低，故典型地与医疗用途相容。大多数聚烯烃由于在焚烧时不产生有害的降解产物，而且多数情况下能以热塑化方式循环再用，因而是环境合格的。许多聚烯烃作为PVC的经济替代物是成本效益好的材料。但是，要用聚烯烃来代替PVC的全部有利属性，尚有许多障碍有待克服。
例如，在用诸如超低密度聚乙烯(ULDPE)之类的聚烯烃制作医用软管时就遇到种种问题。据发现，这种软管的表面特性差，以致在使用滑动夹子夹紧软管时容易把管子切断、夹烂或划伤。ULDPE软管当应用于如下形式的泵压给药装置中时也带来一些难题，这种泵是依靠不断地撞击管壁在给定时间内输送精确数量的液体来控制通过软管的液体流量的。
用来给患者注入医疗试剂的泵一般配有各种传感器以探测例如管内液体的反压及液体流中出现气泡等情况。一旦发现超限的反压或气泡，传感器便把泵关掉。这些传感器通常包括传感器本体，给药装置的一段软管就固定在其中的规定位置上。据发现，当聚烯烃软管被置于该传感器本体内时由于与传感器壳体侧壁相抵而往往发生变形。这种变形在某些情况下会导致探测器发出异常情况指示，从而错误地停下注入泵。
再有，据发现聚烯烃软管的屈服强度低，因而容易产生被称之为缩颈的现象。缩颈是软管在沿其纵向轴线受拉伸时产生适中应变的条件下出现的软管直径局部缩小。缩颈会导致通过软管的液体流量减少或完全受阻，从而使软管失效。由于屈服强度与模量之间存在某种线性关系，因此可以提高材料的模量以提高其屈服强度。但是，要获得医疗用途足够的屈服强度，制成的软管的模量将会高得无法在泵中发挥其功能。
本申请人发现，可以通过使软管沿其纵向轴线预取向来提高软管的抗缩颈能力。但是，取向过程可能导致尺寸不稳定。具体地说，取向的聚烯烃软管会经历一种叫做热恢复，有时也叫做“记忆效应”的现象。热恢复是一种复杂现象，它发生在当取向的软管被加热到超过其取向期间曾经达到过的温度时。当发生热恢复时，软管丧失其取向性，导致软管收缩及尺寸改变。
还发现，聚烯烃软管在储存、运输及最终使用期间热稳定性差。热稳定性差的原因据认为部分地是由于聚烯烃的熔点或结晶温度低、玻璃化转变温度低，以及由上面提到的取向方法所致。聚烯烃软管热稳定性差会导致偏离规定尺寸，并且导致运输或使用期间软管卷曲。这种尺寸及形状的改变又会导致各种功能问题的出现，例如精确度、泵的兼容性等问题，还会引起其他外观缺陷。
发明内容
本发明提供一种制作柔性医用软管的方法，它包括下列步骤：制作具有一条纵向轴线和一定初始直径的聚合物软管，使该软管沿其纵向轴线取向以使软管的直径缩小到规定的取向直径，以及加热取向软管以使软管热定形，从而使软管保持尺寸稳定。优选的是，初始直径比取向直径大10％～300％。优选的是，软管的取向步骤可按湿法或干法工艺实施。每一种取向过程均包括如下步骤：使软管在相隔一定距离的第一拖辊与第二拖辊之间伸长，同时控制第一与第二拖辊的相对速度，使第二拖辊的拖曳速度大于第一拖辊的拖曳速度，从而使软管在二辊之间发生取向。在湿法取向工艺中，软管在取向步骤期间通过一个水浴，而在干法工艺中软管则不通过水浴。
本发明还提供软管的热定形方法，用以克服上面讨论的记忆效应。热定形方法包括让软管暴露于一定温度的步骤，该温度高于软管运输、储存及使用期间正常情况下会遇到的温度，但是又低于软管将会完全熔融的温度。通过让软管暴露于高于使用温度的温度，使有序程度及熔点均较低的晶体熔融，留下在使用温度范围内保持热稳定的熔点较高的晶体。在热定形温度下部分高取向的大分子链也将发生松弛，使得到的软管具有优良的热稳定性。
热定形步骤包括在加热水浴中对经过取向步骤后的软管进行加热的步骤。优选的是，在该加热步骤期间不让软管发生取向，而是令其保持足够的张力以防止软管熔垂。也可以让软管稍微松弛，以便使之略微熔垂。还优选的是，用一种设备支撑着软管以防止或尽量减少软管发生进一步取向。
最后，希望在加热浴中彼此留有一定间隔地设置多个辊筒。将软管绕着这些辊筒拖过形成S形路径，以便使软管往返几程纵向穿过加热浴。希望这些辊筒是电动的。
附图简述
图1是用本发明的单层聚合物共混物制作的医用软管的放大断面图；
图2是本发明的多层软管的放大断面图。
图3是医用软管成形、湿取向及热定形过程的示意图。
图3a是软管在通过图3所示过程的加热或冷却浴时可能遵循的S形路径平面图；以及
图3b是医用软管成形、干取向及热定形过程的示意图。
本发明的最佳实施方式
虽然就本发明的实施可设想出多种不同形式的方案，但是在附图中给出并在下面将要详细描述的是本发明的若干优选的实施方案，其中要理解，本说明书只是本发明原则的举例说明，不拟将本发明的广义方面局限于这些给出的实施方案。
1.聚合物共混物
本发明的聚合物共混物可体现在单层聚合物结构中，或者可粘贴在诸如聚合物的其他基层上以形成多层结构。本发明的聚合物共混物包含聚合材料和添加剂。该聚合物共混物能够制成医用软管且可附着到刚性聚合物上。
该聚合材料可选自聚烯烃及其共聚物，乙丙橡胶，乙烯-乙酸乙烯酯共聚物，乙烯-丙烯酸甲酯共聚物，苯乙烯与烃的嵌段共聚物如苯乙烯-丁二烯-苯乙烯或苯乙烯-异戊二烯-苯乙烯共聚物及其氢化的衍生物，热塑性弹性体如聚氨酯，聚酰胺与聚酯的共聚物如商品名为PEBAX的产品，以及共聚多酯如商品名为HYTREL的产品，聚丁二烯、聚异戊二烯、聚异丁烯、丁苯橡胶以及其他交联的弹性体。
合适的聚烯烃包括聚乙烯的均聚物及共聚物。合适的共聚单体可选自脂族烯烃、丙烯酸甲酯及乙酸乙烯酯。
优选的是，该聚烯烃是乙烯与包括下列α-烯烃的共聚物，与丁烯-1、辛烯-1(统称为超低密度聚乙烯(“ULDPE”))，与丙烯酸甲酯(丙烯酸甲酯共聚单体含量少于33％)，与乙酸乙烯酯(丙烯酸甲酯共聚单体含量少于33％)等的共聚物。ULDPE的密度通常在约0.8克/立方厘米～约0.95克/立方厘米范围内。
该添加剂应为某种聚合物或主链中含有5个以上碳原子的脂族烃或芳烃，其中还应含有如下的电负性基团：胺基；酰胺基；羟基；酸基；乙酸基、铵盐；有机金属化合物，例如金属醇化物、金属羧酸盐以及各种各样1，3-二羰基化合物的金属配合物；苯基膦类；吡啶类；吡咯烷酮类；咪唑啉及噁唑啉类。
该共混物中的聚合物成分含量按重量计应为90％～99.999％，更优选为98.0％～99.99％。添加剂含量按重量计应为0.001％～10％，更优选为0.01％～2％。
2.掺混方法
聚合物共混物的诸成分应通过熔融混合、物理混合如转鼓掺混，或其他方式如反应挤出等方法掺混在一起。
3.制作医用软管的方法
图1中画出用一种本发明的共混物制作的本发明的医用软管10。软管10的内径尺寸应在0.003～0.4英寸范围内，其外径尺寸应在0.12～0.5英寸范围内。更具体地说，在采用医用注入泵，例如商品名为FLO-GARD及COLLEAGUE的Baxter注入泵，以液体给药中使用的医用软管的内径应在0.099～0.105英寸，外径在0.134～0.145英寸，壁厚应在0.018～0.021英寸范围内。该软管应为柔性的，其弹性模量应小于50,000psi(磅/平方英寸)，更优选小于40,000psi。
图2中画出一种多层软管20，它包含作为溶液接触层的第一层22、第二层24以及两层之间的粘结层26。第一层22可选自与上面提到的用于聚合成分的同一类聚合物。然而第一层22将不含有添加剂。第二层24由上面规定的共混物构成，其中含有种类和含量如上述规定的聚合材料及添加剂。在许多情况下，第一层22将是与第二层24充分相容的，以致不用粘结层26也行。
软管20的第一层22的厚度按总壁厚的百分率计应占98％～50％，第二层24的厚度应占2～50％，而粘结层26的厚度应占0～10％。
4.软管的热定形及取向方法
还希望使软管10、20沿其纵向轴线取向。该取向步骤能提高软管沿纵向的屈服强度，从而降低软管在使用当中发生缩颈的倾向。实际上，软管的预取向能提高软管抗拒进一步缩颈的能力。优选的是，软管10、20的取向使得在任何地方其原来的内径及外径比取向后的内径及外径大10％～300％，更优选大20％～120％，最优选大30％～70％。这些范围还包括其间的所有组合及次级组合。下面，把初始直径与取向直径之比称作取向比。取向方法可以是下面描述的湿取向法或干取向法。
图3给出在湿取向过程中软管的取向方法示意30。湿取向法的步骤包括：从聚合物共混物制成软管32，然后将软管32沿其纵向轴线进行取向，使得其具有如上文第“3”部分中所规定的内径及外径以及取向比。该取向步骤使软管的分子沿纵向轴线排列，从而提高以后受到纵向应力时的抗缩颈能力。随后，对软管32实施热定形以减少软管的收缩并将软管固定在取向的尺寸上。
软管32(它可以是单层软管10或多层软管20)按箭头34指示的方向沿着可称之为“线”的连续路径进行拉伸。术语“线上游”将指沿着与软管32行进方向相反方向的线上的部位。反过来，术语“线下游”将指沿着软行进方向的线上的部位。在使用术语“线”时不应理解为该方法必须沿直线进行，而应理解为，该方法是按照某种由若干连贯的步骤组成的顺序进行的。
如图3所示，软管32借助挤出机36而成形。从挤出机36出来的软管32的外径优选地比取向后的外径大10％～300％，更优选大20％～120％，最优选大30％～70％。离开挤出机36的软管直径将被称之为初始直径。
软管32借助第一拖辊37、第二拖辊38、第三拖辊39及第四拖辊40从挤出机36中拉出。拖辊37、38、39及40可带有硅氧烷或橡胶涂层以提高与软管32的摩擦系数。第二拖辊38和第三拖辊39可具有许多沿轴向彼此留有一定间隔并沿圆周延伸的沟槽，以便在拖辊38及39的表面上能同时容纳一组以上的软管32。
离开挤出机36之后，软管32穿过第一冷却浴41，在此软管32借助空气或液体得到冷却。优选的是，第一冷却浴41是温度在4℃～45℃范围的水浴。
离开第一冷却浴41之后，软管32在第一拖辊37与第二拖辊38之间被拉伸，在此软管32由于第二拖辊38的运转速度大于第一拖辊的速度而发生取向，从而达到规定的取向比。“线”的这一段将被称作取向段42。优选的是，第二拖辊38的运转速度为第一拖辊37的约4～10倍。通过控制第一拖辊37与第二拖辊38的相对速度，可以控制软管32的最终内径及外径并达到要求的取向比。
在取向段42中，软管32通过第二冷却浴43，在此软管32借助空气或液体而得到冷却。优选的是，与第一冷却浴41一样，第二冷却浴43是温度在4℃～45℃范围的水浴。
为了克服取向了的软管32的记忆效应，需要将软管加热至某一温度，该温度高于软管运输、储存及使用期间正常情况下会遇到的温度，但是又低于软管完全熔融的温度。通过让软管暴露于高于使用温度的温度，使有序程度及熔点均较低的晶体熔融，留下在使用温度范围内保持热稳定的熔点较高的晶体。部分高取向的大分子链也将发生松弛，使得到的软管热稳定性得到提高。
为此目的，离开第二冷却浴43之后，软管32绕过第二拖辊38并在第二拖辊38与第三拖辊39之间延伸。软管32沿着远离挤出机36的方向前进并穿过加热浴44，在此软管受到热定形。优选的是，加热浴44位于第二冷却浴43的上方以节省占地。然而，这种布置方式是任选的。过程的这一段将被称作热定形段或步骤45。优选的是，热定形步骤45在取向段42之后在线地进行，然而在间歇过程中也可以按离线方式进行。热定形步骤45期间，软管32通过加热浴44，在此软管32借助诸如热空气或液体之类的介质加热。加热浴44优选为温度在约50～99℃之间的水溶液。该水溶液中可加入添加剂，例如盐。
希望软管32在热定形步骤45期间不发生取向。由于这样的缘故，软管32应在第二拖辊38与第三拖辊39之间保持一个极小的张力以便使软管绷紧，或应允许软管有一点熔垂，以便防止或控制收缩。因此，第二拖辊38及第三拖辊39应在相近的速度下操作，或者拖辊39可在比拖辊38稍低的速度下操作，以便容纳一定量的收缩。
为进一步防止软管32在热定形段45中发生取向，当软管32被拖过加热浴44时用支撑结构47对软管32提供支撑也是很好的做法。但是，设置支撑结构47只是任选的。合适的支撑结构47包括一个以与软管32穿过热定形段45相同的速度运动的运输带。另一种支撑结构47是一段直径大于软管32的塑料或金属管，其中软管32靠该管的内表面支撑着。
离开加热浴44之后，软管32在第三拖辊39与第四拖辊40之间延伸。拖辊40的运转速度应与拖辊39的速度相近或比其稍低，以防止更进一步的取向。软管32再次通过第二冷却浴43。当然，也可以另设单独的冷却浴，但是使用同一冷却浴这样的安排能节省占地。
还希望设法让软管32往返几程纵向穿过冷却浴43或加热浴44，如图3a所示，以便在尽量少的空间内提供最大的冷却或加热作用。要做到这一点可以设置多个彼此以一定间隔布置的辊筒49，构成穿过加热浴44或冷却浴43的S形路径。
为防止软管32发生额外的取向，必须使第四拖辊40的运转速度大致等于或稍低于第三拖辊39的速度。
在通过第四拖辊40之后，软管的直径变为取向直径，然后通过切断刀或卷轴48，在此软管32被切断成适当的长度，或者绕在卷轴上以备储存或外运。
图3b画出一种干取向过程30’。该干取向过程与湿取向过程大体相同，主要区别在于，软管32是在拖辊37与37a之间的段42’中进行取向的。拖辊37a的运转速度大于拖辊37。在干取向步骤42’期间，软管32与在湿取向步骤42中的情况不同，它不浸没在水浴43中。在干取向过程中，拖辊38、39及40的运转速度近似或慢于拖辊37a。
5.实施例
A.实施例1
将超低密度聚乙烯，商品名EXACT 4011(埃克森化学公司)，制成软管，取向至各种不同取向比并进行热定形。用量为99.77％(重量)的Exact 4011在转鼓中与用量为0.23％(重量)的Ethomeen 0/15(Akzo Nobel化学公司)进行掺混。
在1.5英寸挤出机(戴维斯(Davis)标准公司)中挤出，制成软管。挤出条件如下：模芯棒外径0.240英寸，口模套内径0.325英寸。机筒1～4段温度分别为：425、428、422、425华氏度。模头1～3段温度分别为：425、425、426华氏度。
离开挤出机的软管绕着由5个拖辊构成的系列拖过，见图3b示意。拖辊1～5的运转速度分别为：17、58、41、32以及33英尺/分。
软管如图3b所示通过加热及冷却浴。加热及冷却浴设备系由Vulcan公司出售的型号为CS60STI的三程定型/冷却系统。热定形浴的温度变化情况列于下表1。该加热浴内设有一系列辊筒，如图3b所示，使软管在加热浴内的停留时间达到13秒钟。
对按照上述条件制成的软管进行了收缩试验。测量并记录每一组软管的管长。然后，软管试样在150°F及50％相对湿度的空气调理箱内放置1小时。然后，取出软管试样并让其冷却至室温。测量并记录试样的长度。算出的长度变化百分率载于表1。
又对另一些软管试样进行了拉伸强度试验。采用LaserMike 183Benchtop光学测微仪测量了软管的内径及外径以及管壁厚度。然后，试样在Instron 4201试验仪上在滑动横梁速度为每分钟20英寸的条件下进行测定。用100％伸长时的应力表示软管的屈服强度，单位为psi，载于表1。
又用Exact 4011按类似条件挤出并成形为软管，但不进行热定形过程。
表1所载结果显示，热定形并取向的软管比未经热定形的软管在尺寸稳定性及屈服强度上均有改善。收缩率是根据放入箱内之前的原长与从箱中取出后的最终长度之间的变化百分率来衡量的。
表1
| 软管成分 | 加热浴温度(℃) | 收缩率 | 屈服强度 |
| Exact 4011 | 未进行 | 21.88 | 920 |
| Exact 4011及Ethomeen | 7374757677787980 | 5.383.002.542 331.600.491.370.19 | 11001030970950850820770730 |
B.实施例2
重复在实施例1中所述的软管制备及测试程序，操作条件略作了修改，制成软管试样，软管原料为乙烯-乙酸乙烯酯(EVA)(UE-634，Quantum化学公司)与Ethomeen 0/15(0.23％(重量))(Akzo Nobel化学公司)的共混物。又用与该共混物中使用的相同牌号的纯EVA制备了软管试样。
机筒1～4段的温度分别为：374、375、378和375华氏度。模头1～3段的温度分别为：375、375、376华氏度。1～5号拖辊的拖辊速度分别为：17、60、41、31及31.5英尺/分。
尺寸稳定性及屈服强度数据载于下表2。
表2
| 软管成分 | 加热浴温度(℃) | 收缩率 | 屈服强度 |
| EVA | 未进行 | 10.00 | 925 |
| EVA及Ethomeen | 707172737475767778 | 4.091.831.671.601.231.231.111.491.76 | 560550595520490510480500510 |
C.实施例3
重复在实施例1中所述的软管制备及测试程序，操作条件略作了修改，制成软管试样，软管原料采用超低密度聚乙烯(ULDPE)(商品名为Dow Affinity VP1770，道化学公司出品)与Ethomeen 0/15(0.23％(重量))(Akzo Nobel化学公司)的共混物。又单独用Dow AffinityULDPE制备了另一种软管试样。
机筒1～4段的温度分别为：424、425、422及425华氏度。模头1～3段的温度分别为：425、425、425华氏度。1～5号拖辊的拖辊速度分别为：17、60、41、31及31.5英尺/分。
尺寸稳定性及屈服强度数据载于下表3。
表3
| 软管成分 | 加热浴温度(℃) | 收缩率 | 屈服强度 |
| VP1770 | 未进行 | 23.75 | 2400 |
| VP1770及Ethomeen | 7475767778798081828384858686 | 4.864.343.963.953.082.031.110.860.430.310.621.001.131.01 | 11401120115011001090107010001030900870800770760720 |
D.实施例4
同样按类似于上述实施例1～3中规定的取向方法制备了软管试样。一组软管试样被取向至50％取向比。第二组试样未进行取向。软管是用载于下表4中的成分即Exact 4011、EVA及VP1770制作的。用下面的方法测定了软管的抗缩颈。首先测定软管的内径和外径及软管长度。将软管的一端夹牢。在该软管的另一端装上一只Chatilon规。该Chatilon规对软管施加一个5磅纵向的力，持续10秒钟。然后，让软管静置5分钟。再次测量软管的尺寸并与初次测量的尺寸数值进行比较。长度尺寸变化百分率载于下表4。
表4
| 软管组成 | 长度变化百分率 |
| Exact 4011 | 28.45 |
| Exact 4011(50％取向) | 0.73 |
| EVA | 15.35 |
| EVA(50％取向) | 0.72 |
| VP 1770 | 11.42 |
| VP 1770(50％取向) | 0.83 |
E.实施例5
用超低密度聚乙烯Exact 4011制备了外径范围在0.139～0.145英寸、内径范围在0.101～0.105英寸的软管。一种软管试样取向至50％取向比，第二种软管试样取向至35％取向比。将取向至50％取向比的软管试样分别浸没在65℃和70℃的水浴中10秒钟；85℃的水浴5秒钟；测定时将软管的另一端夹牢以防止软管移动或收缩。经过热暴露(热水浸泡)之后，松开软管并放在室温水中冷却5分钟，然后测量软管的长度。软管长度变化的差值百分率载于下表5。
然后将软管在57℃的烘箱内放置4小时。测量加热后的长度并将之与放入烘箱之前的长度进行比较。长度差值百分率也载于下表5。
取向比35％的另一种软管试样则没有进行在水浴中的热处理。将该未经热处理的软管放入烘箱内，然后记录下长度差值百分率。表5所载结果显示，热定形步骤大大减少软管收缩的倾向。
表5
| 热定形温度，℃ | 热定形时间，秒 | 烘箱前长度变化％ | 烘箱后长度变化％ |
| 65 | 10 | 1.46 | -3.48 |
| 70 | 10 | 3.75 | -1.40 |
| 85 | 5 | 0 | -0.63 |
| 未进行 | - | - | -21.9 |
虽然已就特定实施方案做了举例和说明，但是在不偏离本发明精神的前提下可能有不胜枚举的修改方案，因此本发明的保护范围仅由所附权利要求的范围限定。
Claims (15)
1.一种制作柔性医用软管的方法，它包括下列步骤：
准备聚合材料；
从聚合材料制备软管，该软管有纵向轴线和一定的初始直径；
沿软管的纵向轴线对软管进行取向，使软管直径缩小到规定的取向直径；以及
对取向直径的软管进行热定形。
2.权利要求1的软管，其中软管的初始直径比取向直径大1O％～300％。
3.权利要求1的方法，其中从聚合材料成形软管的步骤包括用挤出机挤出软管的步骤。
4.权利要求1的方法，其中聚合材料是一种共混物，它包含选自下列的聚合材料：聚烯烃及其共聚物、苯乙烯与烃的嵌段共聚物、苯乙烯与烃的嵌段共聚物的氢化衍生物、热塑性弹性体、聚氨酯、聚酰胺与聚酯的共聚物、共聚多酯、橡胶以及各种交联的弹性体。
5.权利要求4的方法，其中聚合材料选自乙丙橡胶、乙烯-乙酸乙烯酯共聚物、乙烯-丙烯酸甲酯共聚物、聚丁二烯、聚异戊二烯、聚异丁烯和丁苯橡胶。
6.权利要求4或5的方法，其中使软管取向的步骤包括下列步骤：
借助第一拖辊将软管从挤出机拖出；
借助第二拖辊将软管从第一拖辊拉到与第一拖辊相距一段距离的位置；以及
控制第一拖辊与第二拖辊的相对速度，使得第二拖辊拖曳的速度大于第一拖辊的速度以便使软管在两辊之间发生取向。
7.权利要求6的方法，它还包括在软管取向步骤期间使软管冷却的步骤。
8.权利要求7的方法，其中在软管取向步骤期间使软管冷却的步骤包括如下的步骤：提供温度介于4℃～45℃的第一液体浴，以及让软管通过该第一液体浴。
9.权利要求1的方法其中对软管进行热定形的步骤包括使软管受热。
10.权利要求9的方法，其中软管受热步骤包括如下的步骤：
在取向步骤之后对软管进行加热；以及
在该加热步骤之后将软管冷却。
11.权利要求9的方法，其中软管受热的步骤包括提高软管温度，使之高于软管运输、储存及使用期间正常情况下会遇到的温度。
12.权利要求9的方法，其中使软管受热的步骤包括提高软管的温度，但低于软管将会被完全熔融的温度。
13.权利要求9的方法，其中使软管受热的步骤包括暴露于热的液体中。
14.权利要求13的方法，其中热的液体是水。
15.权利要求9的方法，其中软管受热的步骤包括将软管暴露于热空气中。
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- 1996-05-03 US US08/642,657 patent/US5741452A/en not_active Expired - Fee Related
-
1997
- 1997-04-25 EP EP97921405A patent/EP0836550B1/en not_active Expired - Lifetime
- 1997-04-25 AU AU27447/97A patent/AU714189B2/en not_active Ceased
- 1997-04-25 BR BR9702210A patent/BR9702210A/pt not_active Application Discontinuation
- 1997-04-25 CN CN97190834A patent/CN1080184C/zh not_active Expired - Fee Related
- 1997-04-25 CA CA002225163A patent/CA2225163A1/en not_active Abandoned
- 1997-04-25 KR KR1019970709948A patent/KR19990028626A/ko active IP Right Grant
- 1997-04-25 WO PCT/US1997/007032 patent/WO1997042020A1/en active IP Right Grant
- 1997-04-25 MX MX9800142A patent/MX9800142A/es not_active IP Right Cessation
- 1997-04-25 DK DK97921405T patent/DK0836550T3/da active
- 1997-04-25 JP JP9539963A patent/JPH11512674A/ja active Pending
- 1997-04-25 NZ NZ329409A patent/NZ329409A/xx unknown
- 1997-04-25 DE DE69714179T patent/DE69714179T2/de not_active Expired - Fee Related
- 1997-04-30 CO CO97023164A patent/CO4700350A1/es unknown
- 1997-05-02 TW TW086105853A patent/TW343928B/zh active
- 1997-05-02 TR TR97/00340A patent/TR199700340A1/xx unknown
- 1997-05-05 AR ARP970101853A patent/AR007001A1/es unknown
-
1998
- 1998-01-02 NO NO19980007A patent/NO313819B1/no not_active IP Right Cessation
- 1998-10-22 HK HK98111496A patent/HK1010512A1/xx not_active IP Right Cessation
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| JPS5017639A (zh) * | 1973-06-14 | 1975-02-25 | ||
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Also Published As
| Publication number | Publication date |
|---|---|
| CO4700350A1 (es) | 1998-12-29 |
| AU2744797A (en) | 1997-11-26 |
| TW343928B (en) | 1998-11-01 |
| DE69714179D1 (de) | 2002-08-29 |
| NZ329409A (en) | 1999-07-29 |
| DK0836550T3 (da) | 2002-11-04 |
| JPH11512674A (ja) | 1999-11-02 |
| AU714189B2 (en) | 1999-12-23 |
| BR9702210A (pt) | 1999-07-20 |
| HK1010512A1 (en) | 1999-06-25 |
| AR007001A1 (es) | 1999-10-13 |
| DE69714179T2 (de) | 2003-04-03 |
| NO313819B1 (no) | 2002-12-09 |
| EP0836550A1 (en) | 1998-04-22 |
| CA2225163A1 (en) | 1997-11-13 |
| CN1197423A (zh) | 1998-10-28 |
| KR19990028626A (ko) | 1999-04-15 |
| EP0836550B1 (en) | 2002-07-24 |
| TR199700340A1 (xx) | 1997-11-21 |
| WO1997042020A1 (en) | 1997-11-13 |
| NO980007D0 (no) | 1998-01-02 |
| NO980007L (no) | 1998-02-20 |
| US5741452A (en) | 1998-04-21 |
| MX9800142A (es) | 1998-03-31 |
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