CN1642716A - 具有多个室的输注容器及其生产方法 - Google Patents

具有多个室的输注容器及其生产方法 Download PDF

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Publication number
CN1642716A
CN1642716A CNA038069997A CN03806999A CN1642716A CN 1642716 A CN1642716 A CN 1642716A CN A038069997 A CNA038069997 A CN A038069997A CN 03806999 A CN03806999 A CN 03806999A CN 1642716 A CN1642716 A CN 1642716A
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CN
China
Prior art keywords
clinkering
sealing
chambers
infusion container
seal section
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CNA038069997A
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English (en)
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CN100344439C (zh
Inventor
岩崎年晴
小谷政孝
石渡喜代和
吉川克行
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Showa Denko Plastic Products Co Ltd
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Showa Denko Plastic Products Co Ltd
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Priority claimed from JP2003023436A external-priority patent/JP4298308B2/ja
Application filed by Showa Denko Plastic Products Co Ltd filed Critical Showa Denko Plastic Products Co Ltd
Publication of CN1642716A publication Critical patent/CN1642716A/zh
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Publication of CN100344439C publication Critical patent/CN100344439C/zh
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2093—Containers having several compartments for products to be mixed
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
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    • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
    • B29C65/18—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using heated tools
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/01—General aspects dealing with the joint area or with the area to be joined
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    • B29C66/739—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of the parts to be joined being a thermoplastic or a thermoset
    • B29C66/7392—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of at least one of the parts being a thermoplastic
    • B29C66/73921—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of at least one of the parts being a thermoplastic characterised by the materials of both parts being thermoplastics
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C66/80—General aspects of machine operations or constructions and parts thereof
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    • B29C66/814—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps
    • B29C66/8141—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps characterised by the surface geometry of the part of the pressing elements, e.g. welding jaws or clamps, coming into contact with the parts to be joined
    • B29C66/81433—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps characterised by the surface geometry of the part of the pressing elements, e.g. welding jaws or clamps, coming into contact with the parts to be joined being toothed, i.e. comprising several teeth or pins, or being patterned
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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Abstract

本发明涉及一种具有多个室的输注容器及其生产方法。在所述输注容器中，不管薄膜的构造材料和结构如何，所述多个药剂室的一个和另一个之间的分界部分的剥开强度总保持稳定。本发明提供一种具有多个室的输注容器10，所述容器由一个热塑树脂薄膜形成并具有多个用于容纳药剂的药剂室11和12，其中所述药剂室11和12被一个可剥开的弱密封部15液密封，所述弱密封部15形成为具有多个熔结强度不同的熔结部，在这些熔结部中熔结强度最大的强熔结部分散和分布在所述弱封口部分15中，并且所述强熔结部总的占用面积小于所述弱密封部的面积的25％。

Description

具有多个室的输注容器及其生产方法
相关申请的交叉引用
本申请要求2002年9月24日提交的US临时申请No.60/412796的优先权，其全文引用在此作为参照；并且本申请是基于2002年3月28日提交的日本专利申请No.2002-093177和2003年1月31日提交的日本专利申请No.2003-023436提出的，其全文引用在此作为参照。
技术领域
本发明涉及一具有多个室的输注容器，其中可以分别容纳多种药剂并且在需要时这些药剂易于混合，并且本发明还涉及该容器的一种生产方法。
背景技术
在实际治疗中，可混合多种药剂并让患者使用，例如，在生理盐水中混入维生素化合物及其类似物，并将该溶液注射给或输注给患者。在这种混合多种药剂的情况中，如果预先把它们混合，则根据该药剂的种类会发生变质。因此，使用一种具有多个室的输注容器，其中可以分别容纳可能变质的多种药剂并可以在使用之前立即混合。在某些具有多个室的输注容器中，其主体是由热塑树脂薄膜例如聚烯烃形成。
这种由热塑树脂薄膜形成的具有多个室的输注容器必须满足下列要求，即在混合多种药剂之前的阶段药剂室之间的分界部分被液密封(不透液体)但是在混合多种药剂时该分界部分易于剥开以开通室之间的路径并且药剂能快速混合。因此，已对形成该分界部分的方法进行了大量研究。
例如，JP-A-2-4671(这里所用的术语“JP-A”是指“未经审查而公开的日本专利申请”)和JP-A-2000-14746公开了一种带有一种特殊材料的粘合部分以形成一易剥开的分界部分的技术。此外，JP-A-11-169432说明了一种在分界部分的内表面上涂上一种易剥开的涂层剂并因此使剥开更容易的方法。
另一方面，JP-A-8-24314公开了一种技术，其中联合使用两个条片——每个都具有一特定形状的封边——作为热封条以密封该分界部分并将薄膜夹在其间，同时精确控制这些封边的位置，从而该分界部分具有适当的剥开强度。
然而，在JP-A-2-4671和JP-A-2000-14746中公开的技术存在以下问题，即因为形成一易于剥开的分界部分，则该部分必须由多层组成而不能使用单层，并且该薄膜的生产成本较高。同样，JP-A-11-169432中说明的技术有一个问题，即必须使用一种特殊涂层剂，这样增加了生产步骤或生产成本。
在JP-A-8-24314中公开的方法中，不必要形成一种多层结构的薄膜或使用一涂层剂，但必须使用于密封该分界部分的热封条的封边对准，如果它们的位置没有对准则形成的分界部分的剥开强度在各具有多个室的多个输注容器中非常分散(disperse)。此外，在该热封条具有窄的孔距的情况下，位置难以对准，并且即使使该热封温度保持固定，该剥开强度也会分散在各具有多个室的多个输注容器中。要求稳定地生成一种具有期望的剥开强度的具有多个室的输注容器。
发明内容
本发明是在(前述)的这些情况下作出的，本发明的目的是提供一种具有多个室的输注容器，其中不管该薄膜的构造材料和结构如何，该多个药剂室的一个和另一个之间的分界部分的剥开强度总保持稳定。本发明的另一目的是提供一种能够容易地生产这样一种具有多个室的输注容器并具有良好的生产率的方法。
本发明的发明人已发现，当用于使多个药剂室相互隔开的弱密封部形成为具有多个熔结强度不同的熔结部，并控制这些熔结部中熔结强度最大的强熔结部总的占用面积时，可实现上述目的。已在此发现上实现了本发明。这里所用的术语“大的熔结强度”是指剥开被熔结和密封的部分所需的力量大。
另外，本发明中所用的术语“熔结”是指在加热的同时通过挤压来实现粘合，并且不仅表示熔化热塑树脂薄膜熔化并将它们完全结合从而其分界不清楚的情况；而且包括只要保持一液密封可看到该热塑树脂薄膜之间的分界的情况。
本发明的具有多个室的输注容器是由一个热塑树脂薄膜形成的，并具有多个用于容纳药剂的药剂室，其中该具有多个室的输注容器的至少一部分是用一强密封部液密封的，各个药剂室是由一可剥的弱密封部液密封的，该弱密封部形成为具有多个熔结强度不同的熔结部，这些熔结部中熔结强度最大的强熔结部分散和分布在该弱密封部中，并且该强熔结部总的占用面积小于该弱密封部的面积的25％。
用于生产本发明的具有多个室的输注容器的方法是用于生产一具有多个室的输注容器的方法，该输注容器具有多个用于容纳药剂的药剂室，在该输注容器中各个药剂室被一可剥的弱密封部液密封，该方法包括一弱密封步骤，在该步骤中使用两个热封条从两侧将两个叠置的热塑树脂薄膜夹在中间以形成一具有多个熔结强度不同的熔结部的弱密封部，执行该弱密封步骤，从而在那些熔结部中熔结强度最大的并分散和分布在该弱密封部中的强熔结部总的占用面积小于该弱密封部的面积的25％。
附图说明
图1是示出本发明的具有多个室的输注容器的一个示例的俯视图；
图2是示出图1的具有多个室的输注容器的弱密封部的局部放大俯视图；
图3是示出图1的具有多个室的输注容器的弱密封部的进一步局部放大俯视图；
图4是用于形成图1的具有多个室的输注容器的弱密封部的热封条的透视图；
图5是沿图4中的V-V′的剖面图；
图6(a)是沿图3中的I-I′的剖面图，图6(b)是沿II-II′的剖面图；
图7是示出根据本发明的另一示例的具有多个室的输注容器的弱密封部的局部放大俯视图；
图8是与图7相同的俯视图；
图9是用于形成图7的具有多个室的输注容器的弱密封部的热封条的透视图；
图10是沿图8中的III-III′的剖面图；
图11是示出根据本发明的另一示例的具有多个室的输注容器的弱密封部的局部放大俯视图；以及
图12是沿图11中的IV-IV′的剖面图。
具体实施方式
下面详细说明本发明。
[第一实施例]
图1是本发明的具有多个室的输注容器的一个示例，该输注容器由一热塑树脂薄膜形成并具有两个其中将填充药剂的药剂室11和12。在这个示例的具有多个室的输注容器10中，通过一装药部13连接一药剂室11并且通过一药剂入口/出口部14连接另一药剂室12，以向其中装入药剂，并在让患者用药时从该室中排出药剂。
在这个具有多个室的输注容器10中，用一个液密封的弱密封部15分隔开这两个药剂室11和12。将药剂分别填充到各个药剂室11和12中后，热密封弱密封部15，从而在需要时，通过从外部对药剂室11和12中的至少一个施力以剥开该弱密封部并且药剂可以快速地和容易地相互混合。
另一方面，这个具有多个室的输注容器10的外周缘由一强密封部16液密封，即使从外部对药剂室11或12施力也不会剥开该强密封部。在此强密封部中，该热塑树脂薄膜被热密封和牢固地熔结。在此示例中，在具有多个室的输注容器10的外周缘中处处形成强密封部16，然而，例如在将圆柱形热塑树脂薄膜用作材料的情况中，仅在该薄膜的纵向的两个边上(图中是上和下端部)形成强密封部16。不总是必须在整个外周缘上形成强密封部16。
利用两个热封条从两个表面侧将两个叠置的热塑树脂薄膜夹在中间以形成此示例中的具有多个室的输注容器10的弱密封部15，其中每个密封条都具有形成在密封表面上的一特定封边，下面对此进行说明。如在图2的放大俯视图中局部示出的，这个弱密封部形成为具有三个熔结强度不同的熔结部，即一强熔结部15a、一中等熔结部15b和一弱熔结部15c。
在这些熔结部中熔结强度最大的强熔结部15a具有基本正方形的形状，并且基本均匀地分散和分布在弱密封部15中。弱密封部15中熔结强度最小的弱熔结部15c的形状基本为正方形并且比强熔结部15a的形状大，并且该弱熔结部基本均匀地分散和分布在弱密封部15中。熔结强度介于强熔结部15a和弱熔结部15c之间的中等熔结部15b的形状基本为矩形，并且该中等熔结部同样也基本均匀地分散和分布在弱密封部15中。在强熔结部15a、中等熔结部15b和弱熔结15c之中，强熔结部15a的厚度最小而该弱熔结部15c的厚度最大。
此外，将在这三种熔结部中熔结强度最大的强熔结部15a形成为其总的占用面积小于弱密封部15的总面积的25％。
因此，适当地控制弱密封部15的剥开强度，则用于打开该弱密封部所需的力即打开强度也将是适当的，从而这样形成的弱密封部平时可以使药剂室11和12之间保持液体分离，但当从外部对药剂室11或12用力时，可以轻易地剥开并打开该弱密封部。
如果各个强熔结部15a在弱密封部15中占用面积的总和是(总面积的)25％或更多，则该打开强度过大并且在需要时弱密封部15不易剥开，但是如果它们小于0.01％，则该打开强度小而且通过撞击及其类似情况就可剥开该弱密封部。因此，各个强熔结部15a的占用面积的总和优选地从0.01％到25％，更优选地从0.01％到15％并且最优选地从0.05％到10％。
在这个示例的具有多个室的输注容器10中，将各个强熔结部15a分布成即使各个相邻的强熔结部15a之间的间隔的平均值即平均间隔A以及各个相邻的强熔结部15a之间的距离的平均值即平均距离B满足公式(1)：
                    B＜2A            (1)
这里，相邻强熔结部15a之间的距离是相邻强熔结部15a的质心之间的距离，如图3中的符号B1所示，并且平均距离B是这些距离的平均值。同样，相邻强熔结部15a之间的间隔是在相邻强熔结部15a的质心的连线上从一个强熔结部15a的远端到另一个强熔结部15a的远端的距离，如图3中的符号A1所示，并且该平均间隔是这些距离的一个平均值。
当将强熔结部15a分布成满足公式(1)时，弱密封部15的打开强度会更加恒定并易于控制。此外，当平均距离B是1mm或更大，优选地1.5mm或更大，更优选地2mm或更大时，弱密封部15的打开强度会更加恒定并易于控制。平均距离B的上限优选地是10mm，更优选地是5mm。如果B≥2A，则该打开强度会变得太大，并且即使当在需要时对药剂室11或12施力时也不易打开弱密封部15。
在此示例中，每个强熔结部15a具有一个基本正方形的平面，其边长大约是0.2mm(面积：0.04mm2)，平均间隔A是1.8mm，平均距离B是2mm，并且该强熔结部总的占用面积是(总面积的)1％。在每个强熔结部15a都具有这种平面的情况下，每个面积优选地是1 mm2或更小，更优选地是0.5mm2或更小。
根据这个具有多个室的输注容器10，该弱密封部中的各个强熔结部15a的占用面积的总和小于(总面积的)25％，从而可以适当地控制弱密封部15的剥开强度以给出一适当的打开强度，即使当所用的热塑树脂薄膜是例如具有结晶性的聚烯烃树脂的单层薄膜并且其剥开强度较难控制时，也可以控制形成的弱密封部15的剥开强度，从而可以容易无误地把该打开强度控制在合适的范围内。稍后在示例中说明测量打开强度的方法。
在热封一具有结晶性的聚烯烃树脂薄膜的情况下，通常在接近此树脂的熔点的温度下进行密封。然而在该熔点附近会突然发生晶体熔融，甚至热封温度的微小的变化都会引起弱密封部15的剥开强度发生波动。如果该剥开强度象这样波动，则在各具有多个室的多个输注容器10中，弱密封部15的打开强度比较分散，并且不能生产性能稳定的一具有多个室的输注容器。然而，当如上所述控制强熔结部15a的面积时，即使所用的热塑树脂薄膜是具有结晶性的单层薄膜并且在接近其熔点的温度下进行密封，而且该热封温度也发生微小的变化，仍可以将弱密封部15的剥开强度的分散抑制到最小，并且可以稳定地制成打开强度固定的具有多个室的输注容器10。
在这个示例的具有多个室的输注容器10中使用的热塑树脂薄膜优选地是一聚烯烃树脂，因为它便宜并且具有很好的透明度和弹性。其示例包括聚乙烯基树脂例如高密度聚乙烯、中等密度聚乙烯、高压力低密度聚乙烯、低密度聚乙烯、线性低密度聚乙烯和乙烯乙酸乙烯酯共聚物；烯烃基弹性体例如乙烯-丁二烯无规共聚物；聚丙烯基树脂例如聚丙烯、乙烯-丙烯无规共聚物和α-烯烃-丙烯无规共聚物；以及它们的混合物。根据这个具有多个室的输注容器10，不需要选择一种特殊的树脂并用于形成上述的弱密封部15，因此，可以使用在医学领域可用作热塑树脂薄膜的树脂(来形成弱密封部分15)而不需作任何特别限制。同样，可使用由乙烯基氯、乙烯乙酸乙烯酯共聚物、聚醚砜、环状聚烯烃、环状聚烯烃共聚物、苯乙烯基弹性体例如加氢苯乙烯乙烯丁二烯共聚物、由这些树脂中的两种或更多种所构成的混合物，或这种树脂与上述基于聚烯烃基树脂的混合物形成的薄膜。为了提高抗热性或类似特性可以使这些树脂部分地交联。
所用的热塑树脂薄膜可以是由一种薄膜构成的单层薄膜或通过层叠多种薄膜而获得的多层薄膜。在单层薄膜的情况中，优选地是包括线性低密度聚乙烯、乙烯丙烯无规共聚物、乙烯丙烯嵌段共聚物或聚丙烯其树脂和苯乙烯基树脂的弹性的混合物的薄膜，因为它具有很好的透明度和弹性。在多层薄膜的情况中，其示例包括由——从具有多个室的输注容器的外侧向内——高密度聚乙烯/线性低密度聚乙烯、中等密度聚乙烯/低密度聚乙烯/高密度聚乙烯，或高密度聚乙烯/低密度聚乙烯/高密度聚乙烯构成的薄膜。
在多层薄膜中，内层可由易剥的树脂合成物构成。
生成这种薄膜的方法没有具体限制，其示例包括使用T型模具铸造、水冷充气成型、吹塑成型或积层成型的生产方法。考虑到透明度，优选地是T型模具铸造和水冷充气成型。
所用的热塑树脂薄膜的厚度是5到1000μm，优选地50到500μm的数量级。
使用如图4所示的在密封表面上分别具有封边20a和21a的两个热封条20和21从两个表面侧将叠置的两个热塑树脂薄膜夹在中间，可形成具有多个室的输注容器10的弱密封部15。可以把两个薄膜形式的薄片叠置或使用预先成型成圆柱形的一个薄膜来作为该叠置的两个热塑树脂薄膜。除了这两个热塑树脂薄膜之外，在弱密封部15中可插入并密封一层新的薄膜。
在图4的两个热封条20和21中，如图5的放大图中所见，在该密封表面上形成宽度W为0.2mm的凸出条纹以作为封边20a或21a，这些条纹相互平行并且距离P是2mm。将这两个热封条20和21布置成一个热封条20的凸出条纹封边20a与另一热封条21的凸出条纹封边21a成90°交叉，由此将叠置的两个热塑树脂模型夹在中间。
这样，分别用封边20a和21a从两个热塑树脂薄膜表面接触并挤压的部分成为一强熔结部15a，其厚度较小而且被牢固地熔结，没有用热封条20和21的封边20a或21a从两个表面侧接触的部分通过热传导或类似物直接加热并形成一弱熔结部15c，其被不牢固地熔结。仅通过一个热封条20或21的封边20a或21a接触的部分形成一中等熔结部15b，其熔结强度介于强熔结部15a和该弱熔结部15c之间。
因此，使用热封条20和21的宽度W、距离P并根据情况，可预先适当地调整封边的边缘角/棱角(稍后将进行说明)以使分别由封边20a和21a从两个热塑树脂薄膜表面侧接触和挤压的部分的总面积小于整个弱密封部15(的面积)的25％，可以容易地形成一具有固定打开强度的弱密封部15。
此外，根据这种方法，即使该热封温度从最佳温度变化大约1℃，所获得的弱密封部15的打开强度也仅在1000N或更小，优选地750N或更小的范围内波动。即打开强度的变化率是1000N/℃，优选地是750N/℃。实际上，该打开强度优选为300到2000N的数量级，更优选为300到1500N，并根据上述方法，即使该热封温度出现微小偏差该打开强度也易于落在这个范围内。根据所使用的热塑树脂薄膜可以适当地确定该热封温度。包括多个基本平行延伸形成的凸出条纹的封边20a或21a优选地宽度为1mm或更小，更优选地是0.5mm或更小，并且距离P是1mm或更大。
根据这种方法，可以仅使用宽度为W、距离为P的热封条20和21并根据情况形成一具有期望打开强度的弱密封部15，调节封边20a或21a的边缘角以使形成的强熔结部15a总的占用面积小于弱密封部15的面积的25％。因此，液密封具有多个室的输注容器10的外周缘的强密封步骤可以与形成弱密封部15的弱密封步骤同时执行。
更具体地说，使用可以同时将具有多个室的输注容器的形成强密封部16的外周缘这样和形成弱密封部分15的中心部夹在中间的热封条(未示出)，并且如上所述调节形成弱密封部15的部分中的封边20a和21a以使强熔结部15a总的占用面积小于25％，并调节形成强密封部16的部分中的封边，以使即使当对药剂室11或12施力时也不会使该密封部被剥开，由此仅通过利用热封条将该热塑树脂薄膜夹在中间就可同时形成弱密封部15和强密封部16。
如图5所示，在用于形成弱密封部15的热封条上形成的封边的边缘角α优选地是120°或更小。如果该边缘角超过120°则该强熔结部15的面积不易控制。该边缘角优选地是90°或更小，更优选地是60°或更小。
如图6(a)和(b)中所示，分别示意性地示出沿图3的I-I′和II-II′线的剖面图，如此形成的具有多个室的输注容器10的弱密封部15a的状态是，由该热封条20和21的封边20a或21a与该热塑树脂薄膜相接触而形成一凹进部。在此示例的情况下，在沿接触的封边形状的弱密封部15的两个表面上形成凹进条纹22a，该凹进条纹的宽度为大约0.2mm或稍大于0.2mm并且相互平行且彼此距离是大约2mm。在这些凹进条纹22a中，一些是由从两个表面接触-挤压该热塑树脂薄膜的封边20a和21a形成的强熔结部15a，剩余部分是中等熔结部15b，在中等熔结部处，封边20a或21a只从一侧接触该热塑树脂薄膜。
根据封边20a和21a的宽度W或距离P来确定由此形成的凹进条纹22a，然而，示出的宽度W′优选地是大约1mm或更小，距离P′优选地是大约1mm或更大。该宽度W′要等于或稍大于宽度W，距离P′与距离P基本相同。
在此示例中，凹进条纹22a以相对于具有多个室的输注容器10的纵向45°角形成。并没有具体限定这个角度但其优选地是从30°到60°。图2中箭头方向是具有多个室的输注容器10的轴向。
在此示例中，强熔结部15a基本均匀地分散和分布在弱密封部15中，只要强熔结部15a总的占用面积小于弱密封部15的25％，其分布状态在弱密封部15的横向即图1中从左向右的方向上会有所不同。例如，尽管没有示出，强熔结部15a可能在横向的中心部附近分布密集而在该横向的两个边缘部分布稀疏，或者相反地强熔结部15a在横向的中心部附近分布稀疏而在该横向的两个边缘部分布密集。
通过将强熔结部15a形成为在弱密封部15的横向上有不同的分布状态，可以不同地调节弱密封部15例如为剥开和打开提供期望状态，或者即使当具有多个室的输注容器10由于失误而跌落以及对弱密封部15的横向边缘部施力时，也不会使强熔结部打开。为了区分该强熔结部15的分布状态，使用一在密封表面上形成遵循这种分布的一封边的热封条可实现这一点。
〔第二实施例〕
图7示出第二实施例的具有多个室的输注容器10中的弱密封部15。
此示例的弱密封部15也是利用两个在密封表面上形成特定的封边的热封条从两个表面侧将叠置的两个热塑树脂薄膜夹在中间而形成的，并且具有两个熔结强度不同的熔结部即一强熔结部15a和一弱熔结部15c。
其中，将熔结强度高的强熔结部15a形成为一基本正方形的形状和一直线形状。将直线强熔结部15a布置成相互平行并且间隔相等，基本正方形的强熔结部分散和分布在这些直线强熔结部之间。在弱密封部15中除了强熔结部15a之外的所有部分都是熔结强度低的弱密封部15c。
在此示例中，形成这两种熔结部中的剥开强度高的强熔结部15a使得其总的占用面积小于弱密封部15的面积的25％，由此可适当地控制弱密封部15的打开强度。
此外，在此示例中，各个强熔结部15a分散和分布在弱密封部15a中，使得相邻强熔结部15a之间的平均间隔A和平均距离B满足公式(1)的关系。平均距离B优选地是1mm或更大，更优选地是1.5mm或更大，最优选地是2mm或更大。通过这样的平均距离，弱密封部15的打开强度会恒定并非常易于控制。
在此情况下，类似于第一实施例确定如图8所示的基本正方形的相邻熔结部之间的间隔A1和距离B1。一方面，线性强熔结部15a和与之相邻的具有平面形状例如基本正方形形状的强熔结部15a之间的距离B2—当从该平面强熔结部15a的质心向线性强熔结部15a画一条垂直线时—在该垂直线上上述质心和线性强熔结部15a的横向中心点之间的距离。该间距A2是一个强熔结部15a的远端和另一个强熔结部15a的远端之间在该垂直线上的距离。通过平均这些间隔或距离可类似地确定该平均间距A和平均距离B。
当将强熔结部15a形成为具有这样的线性形状和平面形状时，该平面的面积优选地是1mm2或更小，该线的宽度优选地是1mm或更小。在平面形状的情况下，没有将该形状限定为基本正方形，该形状可以是其它多边形或圆形。
使用两个在密封表面上形成图9中所示的封边23a或24a的热封条23和24从两个表面侧将叠置的两个热塑树脂薄膜夹在中间，来形成具有多个室的输注容器10的弱密封部15。
在图9中示出的两个热封条23和24之中，一个热封条23具有与第一示例相同的封边23a，通过在该密封表面上形成彼此平行延伸的多个凸出条纹可获得该封边。另一个热封条24具有封边24a，该封边包括分布成类似等间隔的格子的大量基本正方形的凸出平面。这些热封条将该热塑树脂薄膜夹在中间，从而一个热封条23的凸出条纹封边23a和另一个热封条24的凸出条纹封边24a相互错位。
结果，由封边23a或24a从热塑树脂薄膜的任一表面接触和挤压的部分是强熔结部15a，该强熔结部被牢固地熔结，并且没有由热封条23和24的封边23a或24a从两个表面侧接触的部分通过热传导或其类似方式间接加热并成为一弱熔结部15c，该弱熔结部被不牢固地熔结。
这里，使用热封条23和24的宽度和距离并根据情况，可预先适当地调节每个封边23a和24a的边缘角，使得由封边23a或24a从热塑树脂薄膜的任一表面侧接触并挤压的部分的总面积小于整个弱密封部15的25％，可以容易地形成一具有固定的打开强度的弱密封部15。在使用这种热封条23和24的情况下，封边23a的宽度优选地是1mm或更小而距离优选地是1mm或更大，该封边是基本平行形成的多个凸出条纹。封边24a的面积优选地是1mm2或更小，该封边是一凸出平面。
图10中示出沿图8的III-III′线的剖面图，这样形成的此示例的具有多个室的输注容器10的弱密封部15a的状态是，由热封条23或24的与该热塑树脂薄膜接触的封边23a或24a形成的凹进部。在此示例的情况下，该凹进部形成在弱密封部15的两个表面上，更具体地说，在一表面上形成凹进条纹22a，在另一表面上形成基本正方形的凹进表面22b。形成凹进条纹22a的部分和形成凹进部22b的部分都是强熔结部15a。
这样形成的凹进条纹22a对应所用的热封条的封边的宽度或距离。宽度等于或稍大于该封边的宽度而距离与该封边的距离基本相等。在这样形成的凹进条纹22a中，宽度是1mm或更小，彼此之间的距离是1mm或更大。该凹进平面22b的面积基本等于由一凸出平面构成的封边的面积并且优选地是1mm2或更小。
也可以使用一种薄膜制成的塑模形成由一强熔结部15a和一弱熔结部15c组成的这种弱密封部15，该塑模的抗热性高于所用的热塑薄膜并且其上形成有与要形成的强熔结部15相对应的孔。当通过这个塑模对该热塑树脂薄膜加热时，对应于孔的部分形成强熔结部，该强熔结部被牢固地熔结，而其它部分形成弱熔结部15c。
〔第三实施例〕
图11示出第三实施例的具有多个室的输注容器10的弱密封部15。
此示例的弱密封部15也是通过两个热封条从两个表面侧将叠置的两个热塑树脂薄膜夹在中间而形成的，并具有一强熔结部15a和一弱熔结部15c。
其中，将熔结强度较高的强熔结部15a形成为基本正方形的形状。在弱密封部15中除了强熔结部15a之外的所有部分都是熔结强度低的弱熔结部15c。
同样在此示例中，将强熔结部15a形成为其总的占用面积小于弱密封部15的全部面积的25％，由此可适当地控制弱密封部15的打开强度。
使用一由图9中的标号24所示的具有封边24a的热封条和一具有没有形成封边的平面密封表面(未示出)的热封条从两个表面侧将叠置的两个热塑薄膜夹在中间，可形成具有多个室的输注容器10的这个弱密封部15，封边24a包括分布成等间距的格子的大量基本正方形的凸出平面。由一凸出平面构成的封边24a和该平面密封表面夹住并挤压的部分是强熔结部15a，该强熔结部被牢固地熔结，而仅由该热封条的平面密封表面从一个表面侧接触的部分是弱熔结部15c。
同样在此情况下，当选择并使用热密封条使得上述形成的强熔结部15a总的占用面积小于整个弱密封部15的25％时，可以容易地形成具有固定剥开强度的一稳定的弱密封部15。当使用这种热密封条时，一凸出平面构成的封边24a的面积也优选地是1mm2或更小。
图12中示出沿图11的IV-IV′线的剖面图，这样形成的此示例中的具有多个室的输注容器10的弱密封部15的状态是一凹进部，具体地说，由与热塑树脂薄膜相接触的该热封条的封边仅在一个表面上形成的凹进平面22b。在此示例的情况下，所有的凹进部都是强熔结部15a。
当使用一具有一由面积为1mm2或更小的一凸出平面构成的封边24a的热封条24形成凹进平面22b时，其面积也是大约1mm2或更小。
在形成此示例的弱密封部15的过程中，也可由下列方法形成强熔结部15a和弱熔结部15c。使用一具有没有形成一封边的平面密封表面(未示出)的热封条密封整个部分，并且使用一用标号24示出的具有一封边24a的热封条进一步对此部分进行加热，封边24a包括分布成等间距的格子的大量基本正方形的凸出平面。
在第一实施例到第三实施例这些的具有多个室的输注容器10中，弱密封部15尤其是形成为具有多个熔结强度不同的熔结部，并且在这些熔结部中熔结强度最大的强熔结部15a分散和分布在弱密封部15中并被控制成其总的占用面积小于弱密封部15的面积的25％，由此可适当地控制弱密封部15的打开强度，并且这样形成的弱密封部平时可在药剂室11和12之间保持液密封分隔，但是当从外部对药剂室11或12施力时该弱密封部易于打开。此外，即使所用的热塑树脂薄膜是一具有结晶性的单层薄膜并在接近其熔点的温度下进行密封且同样稍微地改变该热封温度，也可以将弱密封部15的打开强度中的分散抑制到最小并可稳定地生产性能固定的具有多个室的输注容器10。
〔示例〕
下面参照示例来更详细地说明本发明。
〔示例1〕
通过一水冷充气方法制造一厚度为300μm的薄膜，它包括一线性低密度聚乙烯(MFR：2g/10min(190℃)，密度：0.925g/cm3，JIS K6760)构成。
叠置此薄膜的两个薄片，并使用两个热封条从两个表面侧将其夹在中间以形成一可剥开和可打开的弱密封部15和一不可剥开的强密封部16，从而制成一具有多个室的输注容器10，其与图1中所示的(容器)类型相同。这时，将弱密封部15形成为其在具有多个室的输注容器10的纵向上的中心部处的长度为10mm。在这里使用的两个热封条中形成如图4所示基本平行的大量凸出条纹封边，并且该封边的宽度W是0.2mm，距离P是2mm以及边缘角α是90°。在所有情况中，强熔结部15a总的占用面积是弱密封部15的4％。
在4秒的密封时间、0.39MPa的密封压力以及三种热封温度即118℃、119℃和120℃下进行密封。即生产三种具有多个室的密封容器10，它们仅在热封温度上有所不同。
此后，将替代药剂的1000ml有色水填充到上面生产的各个具有多个室的输注容器10的药剂室11和12中，并使用一压缩试验装置(RTC1250A，由Orientec生产)通过一100mm×100mm的板以500mm/分钟的速度挤压一个药剂室11或12。测量打开弱密封部15时的负荷并将其用作弱密封部15的打开强度。
结果是，在热封温度为118℃的情况下生产的具有多个室的输注容器10的弱密封部15的打开强度为253N，在119℃的情况下是760N，在120℃的情况下是1267N。从300到1000N该打开强度的变化率(每变化1℃该打开强度的变化)是507N/℃，这说明即使该热封温度有微小的波动该打开强度也没有很大的变化。
此外，将1000ml有色水填充到各个具有多个室的输注容器10的两个药剂室11和12中，每个容器都被放置在一平坦的桌子上并且用手交替地挤压药剂室11和12，一共5次。结果是，弱密封部15被完全剥开(当该弱密封部在5次内被完全剥开时，在表1中用○表示可开性)。
在每个具有多个室的输注容器10的弱密封部15中，凹进条纹(见图6)的宽度W′和距离P′分别是2mm和0.4mm，并且公式(1)中的平均间隔A和平均距离B分别是1.6mm和2mm。使用该弱密封部放大20倍的照片可测量这些(数据)。
表1和2中共同示出这些结果以及其它数据。
〔示例2〕
以与示例1相同的方式生产三种各具有多个室的输注容器10，只是所用的两个热封条的封边的宽度W、距离P和边缘角α分别是0.2mm、4mm和90°并且热封温度是120℃、121℃和122℃。在弱密封部15中，所有情况下强熔结部15a总的占用面积都是(弱密封部15的总面积的)0.6％。
以与示例1相同的方式求值并在表1和2中示出获得的结果。
从表2可见，在打开强度为300到1000N时该打开强度的变化率较小，这说明，即使热封温度发生微小的变化该打开强度也不会变化很大。(弱密封部15)可开性好。
〔比较示例1〕
以与示例1相同的方式生产两种各具有多个室的输注容器10，只是所用的两个热封条的封边的宽度W、距离P和边缘角α分别是0.4mm、1mm和90°并且热封温度是117℃和118℃。在弱密封部15中，在这两种情况下强熔结部15a总的占用面积都是(弱密封部15的总面积的)25％。
以与示例1相同的方式求值并在表1和2示出获得的结果。
从表2可见，在打开强度为300到1000N时该打开强度的变化率较大，这说明即使热封温度发生微小的变化该打开强度也会变化很大。(弱密封部15的)可开性差(在表2中用×表示)并且弱密封部15的一部分没有被剥开。
〔比较示例2〕
以与示例1相同的方式生产两种各具有多个室的输注容器10，只是所用的两个热封条的封边的宽度W、距离P和边缘角α分别是0.2mm、2mm和150°并且热封温度是117℃和118℃。在弱密封部15中，在这两种情况下强熔结部15a总的占用面积都是(弱密封部15的总面积的)30％。
以与示例1相同的方式求值并在表1和2示出获得的结果。
从表2可见，在打开强度为300到1000N时该打开强度的变化率较大，这说明即使热封温度发生微小的变化该打开强度也会变化很大。(弱密封部15的)可开性差并且弱密封部15的一部分没有被剥开。
〔示例3〕
以与示例1相同的方式生产三种各具有多个室的输注容器10，只是联合使用一具有一包括如图9中所示的凸出条纹的封边的热封条以及一具有一包括凸出平面的封边(正方形凸出平面象一格子那样均匀呈现)的热封条作为两个热封条，该封边任一种的宽度W是0.2mm，距离P是4mm，边缘角α是90°并且热封温度是118℃、119℃和120℃。在弱密封部15中，在所有情况下强熔结部15a总的占用面积都是8％。
以与示例1相同的方式进行求值并在表1和2示出获得的结果。
从表2可见，在打开强度为300到1000N时该打开强度的变化率较小，这说明即使热封温度发生微小的变化该打开强度也不会变化很大。(弱密封部15的)可开性好。
在表1中，测量出如图8所示的强熔结部15a之间的平均距离A1和B1，强熔结部15a是一凹进平面，并测量一作为一凹进平面的强熔结部15a和一作为一凹进条纹的强熔结部15a之间的平均距离A2和B2。
〔示例4〕
以与示例1相同的方式生产三种各具有多个室的输注容器10，只是联合使用一具有一图9中由24所示类型的包括(正方形)凸出平面的封边的热封条以及一具有没有一封边的一平面密封表面的热封条来作为两个热封条，包括凸出平面的该封边的宽度W是0.2mm，距离P是2mm，边缘角α是60°并且热封温度是120℃、121℃和122℃。在弱密封部15中，在所有情况下强熔结部15a总的占用面积都是1％。
以与示例1相同的方式进行求值并在表1和2示出获得的结果。
从表2可见，在打开强度为300到1000N时该打开强度的变化率较小，这说明即使热封温度发生微小的变化该打开强度也不会变化很大。(弱密封部15的)可开性好。
〔比较示例3〕
以与示例1相同的方式生产两种各具有多个室的输注容器10，只是联合使用两个各具有一没有形成一封边的平面密封表面的热封条，并且将两种温度即117℃和118℃用作热封温度。在弱密封部15中，在两种情况下强熔结部15a总的占用面积都是100％。
从表2可见，在打开强度为300到1000N时该打开强度的变化率较大，这说明即使热封温度发生微小的变化该打开强度也会有很大变化。(弱密封部15的)可开性差并且弱密封部15的一部分没有被剥开。
表1
          热封条               具有多个室的输注容器的弱密封部
P(mm) W(mm) α(mm) P′(mm) W′(mm)  强熔结部占用的面积(％) B(mm) A(mm)
示例1    2     0.2     90     2     0.4     4   2   1.6
示例2    4     0.2     90     4     0.3     0.6   4   3.7
示例3 4 0.2 90 4 0.3 8   4(B1)2(B2)   3.7(A1)1.7(A2)
示例4    2     0.2     60     2     0.2     1   2   1.8
比较示例1    1     0.4     90     1     0.5     25   1   0.5
比较示例2    2     0.2     150     2     1.1     30   2   0.9
比较示例3    -     -     -     -     -     100   -   -
表2
                       各密封温度下的打开强度(N) 打开强度的变化率(N/℃) 液体泄漏 可开性
    117(℃)   118(℃)    119(℃)     120(℃)     121(℃)     122(℃)
示例1   253     760     1267     507   ○     ○
示例2     501     771   1041     270   ○     ○
示例3   321     850     1379     529   ○     ○
示例4     366     633     900     267   ○     ○
比较示例1     630   1860     1230   ○     ×
比较示例2     540   1640     1100   ○     ×
比较示例3     720   1900     1180   ○     ×
在将一液体填充到药剂室11和12中后，在示例1到4以及比较示例1到3中得到的所有具有多个室的输注容器10中，没有观察到该液体泄漏进弱密封部15的情况。
工业实用性
如上所述，在本发明的具有多个室的输注容器中，该强熔结部在弱密封部中的总占用面积小于25％，从而不管该薄膜的构造材料和结构如何多个药剂室的一个和另一个之间的分界部分的剥开强度保持稳定。另外，根据本发明的生产方法，这种具有多个室的输注容器易于生产并具有好的生产率。

Claims (18)

1.一种具有多个室的输注容器，它由一热塑树脂薄膜形成并具有多个用于容纳药剂的药剂室，其中
所述药剂室被一可剥开的弱密封部液密封，
所述弱密封部形成为具有多个熔结强度不同的熔结部，
所述熔结部中熔结强度最大的强熔结部分散和分布在所述弱密封部中，
所述强熔结部总的占用面积小于所述弱密封部的面积的25％。
2.根据权利要求1的具有多个室的输注容器，其特征在于，各个强熔结部分布成相邻强熔结部之间的平均间隔A和平均距离B满足下面的公式(1)：
              B＜2A              (1)
3.根据权利要求2的具有多个室的输注容器，其特征在于，强熔结部之间的所述平均距离B是1.0mm或更大。
4.根据权利要求1到3中的任何一个的具有多个室的输注容器，其特征在于，每个强熔结部是一面积为1mm2或更小的平面和/或一宽度为1mm或更小的线。
5.根据权利要求1到4的任何一个的具有多个室的输注容器，其特征在于，所述弱密封部的至少一个表面具有一凹进部，并且所述凹进部的至少一部分是所述强熔结部。
6.根据权利要求5的具有多个室的输注容器，其特征在于，所述凹进部包括多个基本平行并且宽度均为1mm或更小的凹进条纹和/或多个面积均为1mm2或更小的凹进平面。
7.根据权利要求5或6的具有多个室的输注容器，其特征在于，所述弱密封部的一个表面具有所述凹进部而另一个表面是平坦地形成的。
8.根据权利要求5或6的具有多个室的输注容器，其特征在于，所述弱密封部的两个表面都具有所述凹进部。
9.根据权利要求1到8的任何一个的具有多个室的输注容器，其特征在于，各个强熔结部的分散状态在所述弱密封部的横向上是不同的。
10.一种用于生产一具有多个室的输注容器的方法，所述输注容器具有多个用于容纳药剂的药剂室并且其中通过一可剥开的弱密封部使所述药剂室彼此之间液密封，所述方法包括：
一使用两个热封条从两个表面侧将叠置的两个热塑树脂薄膜夹在中间以形成一具有多个熔结强度不同的熔结部的弱密封部的弱密封步骤，
其中，执行所述弱密封步骤，使得所述熔结部中熔结强度最大并且分散和分布在所述弱密封部中的强熔结部总的占用面积小于所述弱密封部的面积的25％。
11.根据权利要求10的用于生成一具有多个室的输注容器的方法，其特征在于，在至少一个所述热封条的密封表面上形成一封边。
12.根据权利要求11的用于生成一具有多个室的输注容器的方法，其特征在于，所述封边包括多个基本平行并且宽度均为1mm或更小的凸出条纹和/或多个面积均为1mm2或更小的凸出平面。
13.根据权利要求11或12的用于生成一具有多个室的输注容器的方法，其特征在于，在一个热封条的密封表面上形成一封边，并且另一热封条的密封表面是平坦地形成的。
14.根据权利要求11或12的用于生成一具有多个室的输注容器的方法，其特征在于，在两个热封条的密封表面上都形成一封边。
15.根据权利要求11到14中的任何一个的用于生成一具有多个室的输注容器的方法，其特征在于，各个封边之间的平均距离是1.0mm或更大。
16.根据权利要求11到15中的任何一个的用于生成一具有多个室的输注容器的方法，其特征在于，每个封边的边缘角是120°或更小。
17.根据权利要求10到16中的任何一个的用于生成一具有多个室的输注容器的方法，其特征在于，所述方法包括一使用热封条从两个表面侧将所述具有多个室的输注容器的外周缘的至少一部分夹在中间以液密封所述外周缘部分的强密封步骤，所述强密封步骤和所述弱密封步骤同时执行。
18.根据权利要求10到17中的任何一个的用于生成一具有多个室的输注容器的方法，其特征在于，执行所述弱密封步骤，使得所述弱密封部中的打开强度相对于热封温度的变化率为1000N/℃或更小。
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