CN1267078C - 医疗用容器的制造方法和医疗用容器 - Google Patents

医疗用容器的制造方法和医疗用容器 Download PDF

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Publication number
CN1267078C
CN1267078C CNB2004100004526A CN200410000452A CN1267078C CN 1267078 C CN1267078 C CN 1267078C CN B2004100004526 A CNB2004100004526 A CN B2004100004526A CN 200410000452 A CN200410000452 A CN 200410000452A CN 1267078 C CN1267078 C CN 1267078C
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container
medical use
port member
thin slice
manufacture method
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CN1526368A (zh
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田岛乡介
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HIKO KOABU CO Ltd
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HIKO KOABU CO Ltd
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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
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • 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
    • B29C65/14—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using wave energy, i.e. electromagnetic radiation, or particle radiation
    • B29C65/16—Laser beams
    • B29C65/1629—Laser beams characterised by the way of heating the interface
    • B29C65/1635—Laser beams characterised by the way of heating the interface at least passing through one of the parts to be joined, i.e. laser transmission welding
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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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
    • B29C65/14—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using wave energy, i.e. electromagnetic radiation, or particle radiation
    • B29C65/16—Laser beams
    • B29C65/1629—Laser beams characterised by the way of heating the interface
    • B29C65/1654—Laser beams characterised by the way of heating the interface scanning at least one of the parts to be joined
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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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
    • B29C65/14—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using wave energy, i.e. electromagnetic radiation, or particle radiation
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    • B29C66/65—General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles with a relative motion between the article and the welding tool
    • B—PERFORMING OPERATIONS; TRANSPORTING
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C66/73—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
    • 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
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
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    • B29C66/80—General aspects of machine operations or constructions and parts thereof
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    • B29C66/812—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 composition, by the structure, by the intensive physical properties or by the optical properties of the material constituting the pressing elements, e.g. constituting the welding jaws or clamps
    • B29C66/8126—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 composition, by the structure, by the intensive physical properties or by the optical properties of the material constituting the pressing elements, e.g. constituting the welding jaws or clamps characterised by the intensive physical properties or by the optical properties of the material constituting the pressing elements, e.g. constituting the welding jaws or clamps
    • B29C66/81266—Optical properties, e.g. transparency, reflectivity
    • B29C66/81267—Transparent to electromagnetic radiation, e.g. to visible light
    • 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
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    • B—PERFORMING OPERATIONS; TRANSPORTING
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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Abstract

本发明提供一种医疗用容器的制造方法，其包括在以不限于包含卤素等极性基的树脂的热塑性树脂作为主成分的薄片或薄膜上，牢固并且可靠地熔接以一种与所述薄片或薄膜相同或不同的热塑性树脂作为主成分的端口构件的步骤，本发明还提供由该制造方法制得的医疗用容器。本发明方法的特征是具有将所述薄片或薄膜成形为袋状，而且将所述端口构件暂时固定在该袋状薄片或薄膜的预定位置处的第1步骤，以及用激光束(35)对该袋状薄片或薄膜(1)与端口构件(5)的暂时固定部(7)进行激光束(35)照射，将该薄片或薄膜与端口构件进行熔接的第2步骤。

Description

医疗用容器的制造方法和医疗用容器
技术领域
本发明涉及医疗用容器的制造方法和由该方法制造出的医疗用容器。
背景技术
在医疗用容器中，存在例如容纳血液和血液成分的“血液袋”、容纳骨髓和淋巴细胞等的活体细胞的“细胞培养用袋”、容纳尿的“采尿袋”、容纳点滴用药液的“输液袋”、容纳直接给予中心静脉用的营养成分的“IVH袋”、容纳经肠给药试剂的袋子、容纳各种药液的袋子等的各种袋子。
一般要求这些医疗用容器具有极高的密封性和牢固性。例如在用于点滴、输血等中的容器，即使从容器泄露出微量的空气，由于血液被氧化或混入细菌等，存在发生感染病症的危险，或者对点滴量、输血量等造成影响，结果给医疗活动造成重大障碍。
另外，医疗用容器经常为了进行灭菌处理等而被置于极高温条件，或者为了进行冷藏或冷冻保存而被置于极低温条件，而且需要对其实施振动、摇动等的处理，但即使这样处理，也不允许其发生一点泄露、破损。而且，还需要其端口部的形状、内径恒定。端口部的形状、内径即使产生微小的变形、歪曲，都不能保证点滴量恒定。因此需要医疗用容器具有极高的品质规格。
在这些医疗用容器中，作为血液袋或输液袋，过去曾有使用玻璃容器的时代。但是由于出现了软袋，其具有柔软性、质量轻、不会破裂以及取出内含溶液时无需通气针的特性，因此现在已被广泛使用。
将这种软袋是将塑料片或薄膜密封，制作形成容器形状的袋。该密封方法主要是通过加热金属模具等以将塑料片或薄膜密封的外部加热法。但是上述外部加热法需要如热金属模具等直至薄片的界面发生熔解，另一方面却不能引起薄片的其它部分或应熔融的构件变形，因此材料受到制约。而且，由于是将在薄片外部产生的热通过薄片传输到密封面为止，提供粘结所需的热，因此将薄片界面熔解所需热能的传导时间或粘结后的冷却时间较费时，存在生产率低的问题。另外，尽管不会产生不能确保形状的形变，但是还存在着容器的加工形状不整齐的问题。
与此相对的是，与外部加热法相比，高频率导电加热密封法是对构成密封材料的分子直接作用高频率能量，由该分子的运动直接使密封材料发热的方法。因此使得应熔融的薄片与薄片之间的界面部分比外侧部分的温度更高，结果其优点是粘结强度高、密封加工的形状整齐等。因此在将聚氯乙烯(PVC)等作为材料的情形下，主要采用高频率导电加热密来制造(例如参照专利文献1)。
但是，对由高频率导电加热引起内部发热的材料的限制是，其分子结构上必须含有极性基团。也就是说，如果通过高频率导电加热，对以不具有卤素等极性取代基的聚烯烃为主成分的薄膜或薄片与端口部件实施密封时，由于薄膜或薄片与端口部件的成形温度不同，造成薄膜或薄片与端口部件之间的粘结力不足。因此，在离心分离实验或高压蒸气灭菌实验中，产生液体泄漏等的问题。
另一方面，由于医疗用容器上附着有血液等，使用后不允许简单地废弃，一般需要进行焚烧处理等，但是涉及到公害问题，因此期望避免使用氯元素类材料。另外，由于聚氯乙烯包含塑化剂，塑化剂可能溶出到内部溶液中，因此认为其在安全性方面存在问题。另外，乙烯-醋酸乙烯酯共聚物可能在成形时发生脱醋酸反应，而使醋酸溶出到内部溶液中。
为解决上述问题并利用高频率导电加热密封方法的优点，已经尝试在由高频率不引发内部发热的材料中混合诱导内部发热的高分子材料或金属材料，以获得必要的发热量的方法，还尝试了在聚乙烯中混合铁粉等金属粉的方法。例如，已提出将不锈钢网等的强磁性体发热材料置于聚烯烃类树脂的粘结面之间，由高频率导电加热使上述发热材料发热，而使粘结面之间熔合的方法(例如参照专利文献2)。但是，上述方法中不锈钢网等的发热材料残留在医疗用容器的内部，不适于作医疗用容器。
此外，作为安装医疗用袋的端口构件的方法，已经公开了采用由高频率导电加热法不引发发热的材料形成医疗用袋的薄片和端口，并采用由高频率导电加热法引起内部发热的2张薄片夹住该薄片和端口进行密封的发明(例如参照专利文献3)。但是，虽然该发明采用高频率振荡器，其密封机制是与加热密封一样的外部加热法，因此仍然不能解决上述问题。
专利文献1特开平9-135880号公报
专利文献2特开昭63-216570号公报
专利文献3特开平9-2427号公报
发明内容
本发明为解决上述问题，提供一种这样的医疗用容器的制造方法，其包括在以不限于包含卤素等极性基的树脂的热塑性树脂作为主成分的薄片或薄膜上，牢固并且可靠地熔接以一种热塑性树脂作为主成分的中空端口构件的步骤，且该热塑性树脂为与所述薄片或薄膜相同或不同的、不限于含有极性基的树脂，本发明还提供由该制造方法制得的医疗用容器。
本发明者为解决上述问题反复进行了研究，结果发现通过外部加热法或其它公知方法的熔接方法，使得以不含极性基的热塑性树脂作为主成分的薄膜或薄片和与该薄膜或薄片相同或不同的、不含极性基的热塑性树脂作为主成分的中空端口构件暂时固定，此后如果采用激光对该端口构件与薄膜或薄片构件的暂时固定部进行熔接，可对上述薄膜或薄片与端口构件之间实施牢固地密封，并可提供具有高粘结强度，而且形状端整的医疗用容器。也就是说，本发明为
(1)一种医疗用容器的制造方法，其为在由热塑性树脂形成的薄片或薄膜上，安装了由与该薄片或薄膜相同或不同的热塑性树脂形成的端口构件的医疗用容器的制造方法，其特征是具有将所述薄片或薄膜成形为袋状，而且将所述端口构件暂时固定在该袋状薄片或薄膜的预定位置处的第1步骤，以及用激光束对该袋状薄片或薄膜与端口构件的暂时固定部进行照射，对该暂时固定部进行熔接的第2步骤。
(2)如上述(1)记载的医疗用容器的制造方法，其中所述第2步骤是旋转所述暂时固定了所述端口构件的袋状薄片或薄膜，对端口构件的外围部进行激光束照射。
(3)如上述(1)记载的医疗用容器的制造方法，其中所述第2步骤是在凹形弯曲表面上以与激光束呈直角的方向移动所述暂时固定了所述端口构件的袋状薄片或薄膜，对端口构件外围部的半圆周部分进行激光束照射，然后，反向旋转袋状薄片或薄膜，在凹形弯曲表面上以与激光束呈直角的方向移动袋状薄片或薄膜，对端口构件外围部的另一半圆周部分进行激光束照射。
(4)如上述(1)到(3)任一项记载的医疗用容器的制造方法，其中所述第2步骤是采用从薄片或薄膜外侧施加的空气压，将所述薄片或薄膜与端口构件压接，然后用激光束对端口构件的外围部进行照射的步骤。
(5)如上述(1)到(4)任一项记载的医疗用容器的制造方法，其中所述第1步骤是对用于将薄片或薄膜成形为袋状的一个金属模具，与该金属模具对应的另一金属模具，以及插入到端口构件中空部分中的芯部金属施加高频率电压的步骤。
(6)如上述(1)到(5)任一项记载的医疗用容器的制造方法，其中位于所述暂时固定部的薄片或薄膜由透明体或半透明体形成，端口构件的熔接部分的遮光率为50％～100％。
(7)如上述(1)到(6)任一项记载的医疗用容器的制造方法，其中所述薄片或薄膜由单层或多层结构形成。
(8)如上述(1)到(7)任一项记载的医疗用容器的制造方法，其中所述热塑性树脂为不含极性基的热塑性树脂。
(9)如上述(1)到(8)任一项记载的医疗用容器的制造方法，其中所述热塑性树脂为包含聚乙烯、聚丙烯、聚丁烯、聚丁二烯、聚异戊二烯、聚-4-甲基戊烯-1、聚苯乙烯、聚醋酸乙烯酯、聚甲基丙烯酸甲酯、聚甲基丙烯酸乙酯、聚丙烯酸、环状聚烯烃、聚丙烯腈、聚酰胺(尼龙)、聚酯、聚氨酯、聚碳酸酯、聚酰亚胺、聚苯硫醚中的至少1种的均聚物，和/或共聚物和/或共混聚合物。
(10)如上述(1)到(9)任一项记载的医疗用容器的制造方法，其中所述热塑性树脂为热塑性弹性体和/或包含该热塑性弹性体的共混聚合物。
(11)如上述(9)中记载的医疗用容器的制造方法，其中所述共聚物为包含乙烯-丙烯共聚物、乙烯-丁烯共聚物、乙烯-己烯共聚物、乙烯-辛烯共聚物的乙烯-α-烯烃共聚物、乙烯-醋酸乙烯酯共聚物、乙烯-醋酸乙烯酯共聚物的皂化物、乙烯-丙烯酸共聚物、乙烯-丙烯酸乙酯共聚物、乙烯-甲基丙烯酸甲酯共聚物、乙烯-马来酸酐共聚物、离聚物、以苯乙烯和/或乙烯为主成分的部分和由丁二烯和/或异戊二烯和/或这些物质的加氢物形成的部分构成的嵌段共聚物、聚酰胺(尼龙)-聚醚嵌段共聚物、聚酯-聚醚嵌段共聚物、聚酯-聚酯嵌段共聚物、聚醚类或聚酯类、聚碳酸酯类的聚氨酯弹性体。
(12)如上述(1)到(11)任一项记载的医疗用容器的制造方法，其中所述热塑性树脂由以苯乙烯和/或乙烯为主成分的部分和由丁二烯和/或异戊二烯和/或这些物质的加氢物形成的部分构成的嵌段共聚物，以及聚丙烯和/或聚乙烯和/或聚丁烯的共混聚合物形成。
(13)如上述(7)到(12)任一项记载的医疗用容器的制造方法，其中所述多层结构的容器最内层由选自聚酰胺弹性体、聚酯弹性体、聚氨酯弹性体中的热塑性弹性体和/或包含这些弹性体的共混聚合物形成的。
(14)如上述(1)到(13)任一项记载的医疗用容器的制造方法，其中所述医疗用容器至少为容纳血液和血液成分的袋子、容纳骨髓、淋巴液、尿等的体液的袋子、输液袋、容纳直接给予中心静脉等用的营养成分的袋子、容纳经肠给药营养剂的袋子或者容纳各种药液的袋子中的任何一种袋子。
(15)采用上述(1)到(14)任一项记载的医疗用容器的制造方法制造的医疗用容器。
根据本发明的医疗用容器的制造方法可获得这样的医疗用容器，在由不含极性基的热塑性树脂形成的薄膜或薄片与端口构件的熔接处，其粘结强度高，而且不发生熔融不均现象，在离心分离实验或耐高压蒸气实验中也不会发生泄漏。由本发明制造方法制造的医疗用容器可合适地用于容纳血液和血液成分的袋子、容纳骨髓、淋巴液、尿等的体液的袋子、输液袋、容纳直接给予中心静脉用的营养成分的袋子、容纳经肠给药营养剂的袋子或者容纳各种药液的袋子等。
附图说明
图1是表示根据本发明制造方法制造的医疗用容器的一个实例的说明图。
图2是说明本发明第1步骤中采用的高频率焊接机的金属模具、芯部金属的一个参考例的透视图。
图3是显示本发明第2步骤中所用的激光束熔接的装置的示意图。
图4是说明粘结强度实验方法的说明图。
符号说明
1袋状部
3密封部
5端口构件
7暂时固定部
11、12金属模具
13芯部金属
15A、15B电极
17切刀
21袋状部支撑装置
23端口构件支撑棒
25按压机构
30激光熔接结构
31激光振荡器
33斑点形状调节机构
35激光束
具体实施方式
本发明医疗用容器的制造方法的特征是包含采用外部加热法以及其它公知方法的熔接方法，在对薄片或薄膜成形为袋状的同时，将所述端口构件暂时固定在该袋状薄片或薄膜的预定位置处的第1步骤，以及用激光束对所述袋状薄片或薄膜(以下有时也称其为袋状部)与端口构件的暂时固定部进行照射，对薄片或薄膜与端口构件之间的暂时固定部实施熔接的第2步骤。以下基于附图对本发明作详细说明。
图1是表示根据本发明的制造方法制造的医疗用容器的一个实例的说明图。在图1中袋状部1由密封部3粘结，并形成袋状。端口构件5根据医疗用容器的目的，可以为1或2个或其以上。该端口构件5和与袋状部1相粘结的粘结部(上述暂时固定部)7中的袋状部紧密粘结。
(医疗用容器的制造方法)
作为本发明第1步骤的成形袋状部、以及暂时固定端口构件的方法，只要为可将同一材料、同一成形温度的袋状部的密封部紧密粘结的方法均可，可采用外部加热法或导电加热法等的公知的熔接方法。其中由导电加热法引起的内部加热法可成形为无毛刺的袋状部，因此优选。
图2为表示根据导电加热法、实施本发明第1步骤的袋状部成形和暂时固定端口构件用的一个装置实例的透视图。在图2中，金属模具11和12夹持着薄膜或薄片。对与图1密封部3对应的金属模具11的电极15A和金属模具12的电极15B，和插入到端口构件5的中空部的芯部金属13施加高频率电压，在使袋状部的密封部紧密粘结的同时，将端口构件暂时固定在与袋状部1相粘结的暂时固定部7。另外，在上述金属模具11的电极15A和12的电极15B的外围安装有切刀17，将薄膜或薄片成形为所希望形状的容器。
另外，在本发明中使用的高频率电压的振荡器可采用市售的高频率振荡器，具体可合适地采用精电舍电子工业株式会社制造的KV-5000TU-P，KV-7000TU-P、KV-8000TU-P等的高频率焊接机。
图3为表示本发明第2步骤的、对端口构件5与袋状部1在暂时固定部7处进行熔接的方法的装置的示意图。该熔接装置具有与安装袋状部1用的、与后述按压机构相连的、旋转或移动的袋状部支撑装置21，保护插入到端口构件5的中空部中的端口构件5的暂时固定部，以不受后述的按压机构产生的压力影响用的端口构件保护棒23，从该袋状部的外侧按压袋状部与端口构件的暂时固定部，以使端口构件与袋状部紧密粘结用的按压机构25。在端口构件与袋状部的暂时固定部7处，由按压机构25产生的压力进行按压，使其互相处于紧密粘结的状态，从激光焊接机30发出的激光束35进行照射，暂时固定部被熔接。
如图3所示，上述激光焊接机30具有半导体激光器等的激光振荡器31，和对激光振荡器31发出的激光束35的斑点形状进行调整用的斑点形状调节机构33。所述斑点形状调节机构33采用公知的例如圆柱形透镜等构成，可将激光束35仅聚光到一个方向上，并成像为长椭圆状。
作为上述激光焊接机30的激光束，可合适的采用半导体激光器或二氧化碳等的气体激光器，其中半导体激光器具有易于透过透明体、半透明体的性质，因此特别优选。在本发明中，激光振荡器的输出功率优选在1W到1000W的范围内。另外，上述激光束的波长优选为500～1300nm，其中更优选为700～900nm，特别优选750～850nm。
激光束的上述斑点形状调节机构33与暂时固定部之间的距离(以下称为工作距离)优选为30mm～400mm，其中更优选为50mm～300mm，特别优选80mm～250mm。
另外在对将被熔接的暂时固定部的照射，为了使激光束成像为长椭圆状，必须保证与激光束焦点存在一定的距离。焦点透镜至焦点之间的距离h与焦点至暂时固定部之间的距离ho之间的比h/ho(以下称为h/ho比)优选为30～400，其中更优选为50～300，特别优选为80～250。
在激光束对暂时固定部进行照射时，对暂时固定部的一部分进行环状照射时其粘结效果高，但是从牢固熔接的观点出发，优选对暂时固定部的全部进行照射熔接。
用于本发明的激光振荡器31可采用市售的激光振荡器，具体可合适地采用精电舍电子工业株式会社制造的激光振荡器LD100等。
上述激光焊接机构30的激光振荡器31配置在上述暂时固定部7的上部处，激光束35透过按压机构25，呈长椭圆形状地照射暂时固定部7，该椭圆形状具有与端口构件保护棒23平行的长径。袋状部支撑装置21具有使激光束35对位于暂时固定部的端口构件5的外围不进行全部照射的机构，该机构同时确保上述斑点形状调节机构33和位于暂时固定部7的端口构件5的外围之间存在一定的距离。具体优选的是袋状部支撑装置21与相连的按压机构25形成为一体，为以端口构件保护棒23为中心的旋转机构，或与激光束35呈直角方向在凹形弯曲面上移动的机构，其中优选旋转机构。另外，当为与激光束35呈直角方向地在凹形弯曲面上移动的机构时，优选激光振荡器31与斑点形状调节机构33为可动式的。袋状部支撑装置21的移动速度优选对端口构件的外围照射1周的时间为5秒～25秒，其中更优为选8秒～18秒。
通过对端口构件的外围部照射激光，可使袋状部与端口构件之间的接触面(上述的暂时固定部)相互焊接在一起，可以进行牢固而且稳定的熔接。
为了使激光束透过上述袋状部与端口构件，上述袋状部与端口构件必须为透明体或半透明体。另外，为了将激光束的光能量转变为热，端口构件中与袋状部熔接的部分的遮光率优选在50％或其上，更优选在80％或其以上。此处的遮光率可以是根据JIS Z 8720规定的标准光源A测定的遮光率，具体优选的是对激光吸收率高的黑色或与其相近的颜色，但是由于碳容易被碳化，因此不优选。
由于上述按压机构25通过按压暂时固定部外侧的袋状部，使暂时固定部处的端口构件与袋状部紧密粘结，因此可以采用机械压力机构或气体加压机构等任何一种方式，其中从提高端口构件与袋状部的粘效果出发，优选向气球形状的弹性体中注入空气，以对袋状部外面加压的机构。为了使激光束透过按压机构，按压机构必须为透明体或半透明体。
熔接完成后，从袋状部的暂时固定部拔出端口构件保护棒23，袋状部支撑机构21由图中未示出的袋状部输送装置进行输送，其间，熔部自然冷却。对于熔接部的冷却，也可以安装冷却扇等的强制冷却装置对熔接部进行强制冷却。
(薄片或薄膜)
作为本发明中的热塑性树脂没有特别限制。具体地例如为包含选自聚乙烯、聚丙烯、聚丁烯、聚丁二烯、聚异戊二烯、聚-4-甲基戊烯-1、聚苯乙烯、聚醋酸乙烯酯、聚甲基丙烯酸甲酯、聚甲基丙烯酸乙酯、聚丙烯酸、环状聚烯烃、聚丙烯腈、聚酰胺(尼龙)、聚酯、聚氨酯、聚碳酸酯、聚酰亚胺、聚苯硫醚中的至少1种的均聚物，和/或共聚物和/或共混聚合物。
作为上述共聚物，可例举出包含乙烯-丙烯共聚物、乙烯-丁烯共聚物、乙烯-己烯共聚物、乙烯-辛烯共聚物的乙烯-α-烯烃共聚物、乙烯-醋酸乙烯酯共聚物、乙烯-醋酸乙烯酯共聚物的皂化物、乙烯-丙烯酸共聚物、乙烯-丙烯酸乙酯共聚物、乙烯-甲基丙烯酸甲酯共聚物、乙烯-马来酸酐共聚物、离聚物、以苯乙烯和/或乙烯为主成分的部分以及由丁二烯和/或异戊二烯和/或这些物质的加氢物形成的部分构成的嵌段共聚物、聚酰胺(尼龙)-聚醚嵌段共聚物、聚酯-聚醚嵌段共聚物、聚酯-聚酯嵌段共聚物、聚醚类或聚酯类、聚碳酸酯类的聚氨酯弹性体等。
另外，作为用于本发明的，不合卤素元素的热塑性树脂的其它实例，可优选使用热塑性弹性体和聚烯烃的共混物。作为聚乙烯的具体实例，可举出低密度聚乙烯(LDPE)、高密度聚乙烯(HDPE)、线型低密度聚乙烯(LLDPE)等。另外，作为聚丙烯的具体实例，可举出均聚物、无规共聚物、嵌段共聚物或者等规立构聚丙烯、无规立构聚丙烯、间规立构的聚丙烯等。
另外，作为用于本发明的薄片、薄膜、端口构件的原料的热塑性树脂，可优选使用上述以苯乙烯和/或乙烯为主成分的部分以及由丁二烯和/或异戊二烯和/或这些物质的加氢物形成的部分构成的嵌段共聚物，以及由聚乙烯和/或聚丙烯和/或聚丁烯的共混聚合物形成的热塑性树脂。这些树脂在特开昭54-88950号公报、特开平4-314452号公报等中有记载，可提供透明、柔软以及可高压釜灭菌的医疗用袋。
在本发明中所用的薄片或薄膜可以为单层，也可以为多层结构。而且，对该薄片或薄膜的厚度没有特别限制。但优选为0.05mm～2mm。不足0.05mm时，作为医疗用容器时，不能确保其强度，而超过2mm时，在柔软性方面出现问题。
在为多层结构的薄片的情况下，可采用对内表面施加高频率时内部容易发热的材料，即可采用现有的作为可高频率密封材料的聚酰胺、聚酯、聚氨酯，有时优选这些材料。但是，这些由高频率密封而发热的材料的厚度优选为占全部厚度的2％～95％。对本发明中所用的多层结构的薄片或薄膜的制造工序没有特别限制。例如可以采用干法层压、湿法层压、共挤出成形中的任何一种方法，也可以使用其它方法。本发明所用薄片或薄膜优选由多层结构的薄片构成，其中医疗用容器的最内层为选自聚酰胺弹性体、聚酯弹性体、聚氨酯弹性体中的热塑性弹性体。
作为聚酰胺弹性体，为一种多嵌段共聚物，其中采用结晶性的熔融温度高的聚酰胺作为其硬段、非晶质的玻璃转移温度低的聚醚或聚酯作为其软段，即可优选使用聚醚酰胺(也称作聚醚酯酰胺)或者聚酯酰胺。
作为聚酯弹性体，可优选使用一种聚酯、聚醚型，其中以芳香族聚酯、例如1，4-丁二醇和邻苯二甲酸的缩聚物作为硬段，将脂肪族聚醚的聚丁二醇作为软段，或者采用聚酯聚酯型，其中采用脂肪族聚酯作为软段。
作为聚氨酯弹性体，优选的是使用4，4-二苯基甲烷二异氰酸酯(MDI)1，4-丁二醇(BD)作为链延长剂的、将聚醇或聚酯作为软段的聚氨酯。
(其他方面)
根据本发明的方法，对制造医疗用容器时的环境、气氛等没有特别限制。但是，优选例如以美国航空宇宙局(NASA)的标准，在100～10000级别的干净房间或干净容器内等进行激光熔接。
在薄片或薄膜互相粘结的情况下，或者在薄片或薄膜与端口构件相粘结的情况下，根据本发明方法制造的医疗用容器的粘结部分的粘结强度优选为0.1kgf/cm2或其以上，更优选为0.8kgf/cm2或其以上。在为装入输液或药液等进行高压釜灭菌或为装入血液实施离心分离时的医疗用容器的情况下，该粘结强度是必须特别注意的值。粘结强度不足0.1kgf/cm2时，在对装入了输液或药液后进行高压釜灭菌或在装入血液后实施离心分离时，粘结部分可能会剥落。
本发明的医疗用容器只要是在医疗现场使用的容器，对其没有特别限制，对其种类、形状、大小、颜色、印刷的有无也没有特别限制。作为本发明医疗用容器的具体实例，可列举出例如，容纳血液和血液成分的“血液袋”、容纳骨髓或淋巴细胞等的活体细胞的“细胞培养用袋”、容纳尿的“采尿袋”、容纳点滴用药液的“输液袋”、容纳直接给予中心静脉用的营养成分的“IVH袋”、容纳经肠给药营养剂的袋子、容纳各种药液的袋子等的各种袋子。
向本发明医疗用容器填充内含物的方法没有特别限制。具体例如从端口构件的中空部填充内容液，根据需要除去内部空气，然后在该端口构件的前端的中空部安装橡胶塞。为保持该橡胶塞的上表面无细菌，优选在其上贴附塑料制的薄膜或者盖上顶盖。在内含物为输液的情况下，该橡胶塞用于在容器内混合根据患者的抗生素或胰岛素等的药剂。此后，通常在高压釜中在121℃下进行20分钟的灭菌处理。
在上述血液袋、细胞培养用袋、采尿袋的情况下，可以未填充内含物的形式在市场销售。
实施例
以下根据实施例进行更具体的说明，但是本发明不受这些实施例的限制。
(实施例1)
将以聚丙烯为主成分的聚烯烃(商品名称：H：FAS-透明200μ、大仓工业株式会社制造)作为原料，在挤出实验机(Labo Plastomill，由东洋精机制作所制造)上安装120mmT模，制得厚度约0.20mm的薄片。
另外，将以聚丙烯为主成分的聚烯烃(商品名称：Ultracene 751、由Toso株式会社制造)作为原料，用射出成形机(FS 80S12ASE、日精树脂工业株式会社制造)成型为中空部的内径为6mm、壁厚为1mm、外径为8mm的端口构件。另外，对该端口构件预定与薄片熔接的部分的外周面着色为黑色。基于JIS Z8720的标准，由标准光源获得的遮光率为98％。
如图2所示，将上述薄片和端口构件安装在金属模具上，采用高频率的焊接机KV-5000TU-P(精电舍电子工业株式会社制造)进行高频率密封，形成袋状，制造出暂时固定有端口构件的袋状部1。端口构件5与袋状部1的暂时固定部7的密封宽度为10mm，袋状部的密封部3的密封宽度为5mm。
密封条件为振荡频率40.46MHZ±0.599％，施加电压200V，输出7KW、金属模具的温度为90±5℃，施加时间为5秒，冷却时间为5秒。
另外，将用上述操作制造的袋状部上暂时固定有端口构件的产品作为比较例1的医疗用容器。
对于根据上述方式制得的暂时固定有端口构件的袋状部，采用如图3所示的熔接装置对暂时固定部7的薄片和端口构件进行熔接。将袋状部1安装在袋状部支撑装置21上，将端口构件保护棒23插入到端口构件5的中空部后，操作按压机构25，从外围按压袋状部的暂时固定部7，使端口构件与袋状部紧密粘结。在暂时固定部7处，端口构件与袋状部以互相紧密粘结的状态，使袋状部支撑装置22旋转的同时，从激光焊接机构30发出的激光束35按照以下所述的照射条件进行照射，使暂时固定部处的端口构件与袋状部熔接在一起，得到实施例1的医疗用容器。照射条件为电压200V，激光束的输出功率为100W，波长为808nm±3nm，工作距离为200mm，h/ho的比为99、斑点长径为2mm、照射时间为10秒、冷却时间为10秒。
(实施例2)
采用和实施例1一样的薄片和端口构件，除了将激光束的照射条件改变为电压200V，激光束的输出为30W，波长为808nm±3nm，工作距离为100mm，h/ho的比为99、斑点长径为1mm、照射时间为15秒、冷却时间为15秒以外，采用与实施例1一样的方式制得实施例2的医疗用容器。
(实施例3)
除了用以聚丙烯为主成分的聚烯烃(商品名称：TP200H、太洋塑料株式会社制造)代替实施例1的聚烯烃(商品名称：HIFAS-透明200、大仓工业株式会社制造)作为薄片原料以外，采用与实施例1一样的方式制得实施例3的医疗用容器。
(实施例4)
除了采用与实施例3一样的原料以外，采用与实施例2一样的方式制得实施例4的医疗用容器。
(比较例1)
采用与实施例1一样的薄片和端口构件，采用与实施例1一样的金属模具和高频率焊接机，采用与实施例一样的密封条件进行熔接，得到比较例1的医疗用容器。也就是将实施例1中暂时固定的容器作为比较例1的实验品。
(比较例2)
除了采用与实施例3一样的薄片和端口构件以外，采用与比较例1一样的方式制得比较例2的医疗用容器。
(粘结强度的评价)
图4中示出了用于本发明袋状部与端口构件粘结部(上述暂时固定部7)的粘结强度实验的试样。将袋状部与端口构件的暂时固定部7(长度为10mm)全体用激光束进行焊接，冷却后，将包含粘结部的薄片以与端口构件5平行的方式进行切割，使得从端口构件边缘延伸的薄片残片43的宽度在端口构件的两侧分别为1.5mm，继续对该切片进行切割，使得延长切割后袋状部的薄片45，47为30mm，制作出抗张强度试验的试样。将抗张实验机(岛津制作所制Autograph)的夹头间距设置为20mm，夹住薄片45，47，以200mm/分钟的拉伸速度，在(23℃)下以箭头所示方向拉伸，直至破坏实验片，将此时所得值除以2，进一步换算出每1cm薄片45，47横向宽度的的值，将其作为粘结强度，在各实施例，比较例中，都求出5个试样的平均值。评价结果示于表1。
(泄漏的评价)
在上述本发明医疗用容器中，装入牛血200ml，封闭端口构件5的中空部后，以3000rpm-10分钟实施离心分离(离心分离实验)，此后，将该医疗用容器静置于白色纱布上1小时，根据白色纱布是否着色来判断内含的血液是否泄漏。20个试样的评价结果示于表1。
                     表1
  粘结强度(kg/cm2)   泄漏个数(/20)
  实施例-1   5.3   0
  实施例-2   5.5   1
  实施例-3   5.5   0
  实施例-4   5.4   0
  比较例-1   4.8   10
  比较例-2   4.7   11
由表1可知，构成本发明医疗用容器的袋状部与端口构件的粘结状态良好，尽管实施例和比较例都牢固地粘结，但是任一个实施例都比比较例的强度高。
另一方面，在泄漏评价中，虽然在实施例2中发现有一个微量着色的纱布，但是其它实施例中未发现有泄漏，结果良好。与此相对的是，发现比较例1有10个，比较例2有11个发生泄漏，约半数产生泄漏，不能认为是一种完美的粘结状态。
(外观形状的评价)
焊接程度采用目视方式进行确定，发现各实施例成品的端口构件表面无熔融不均现象，具有整齐的外观，而各比较例中端口构件表面发生熔融不均现象，不能认为其良好。

Claims (15)

1.一种医疗用容器的制造方法，其为在由热塑性树脂形成的薄片或薄膜上，安装了由与该薄片或薄膜相同或不同的热塑性树脂形成的端口构件部的医疗用容器的制造方法，其特征是具有将所述薄片或薄膜成形为袋状，而且将所述端口构件暂时固定在该袋状薄片或薄膜的预定位置处的第1步骤，以及用激光束对所述袋状薄片或薄膜与端口构件的暂时固定部进行照射，对该暂时固定部进行熔接的第2步骤。
2.如权利要求1记载的医疗用容器的制造方法，其中所述第2步骤是旋转所述暂时固定有所述端口构件的袋状薄片或薄膜，对端口构件的外围部进行激光束照射。
3.如权利要求1记载的医疗用容器的制造方法，其中所述第2步骤是在凹形弯曲表面上以与激光束呈直角的方向移动所述暂时固定有所述端口构件的袋状薄片或薄膜，对端口构件外围部的半圆周部分进行激光束照射，然后，反向旋转袋状薄片或薄膜，在凹形弯曲表面上以与激光束呈直角的方向移动袋状薄片或薄膜，对端口构件外围部的另一半圆周部分进行激光束照射。
4.如权利要求1到3任一项记载的医疗用容器的制造方法，其中所述第2步骤是采用从薄片或薄膜外侧施加的空气压，将所述薄片或薄膜与端口构件压接，并进行激光束照射的步骤。
5.如权利要求1到3任一项记载的医疗用容器的制造方法，其中所述第1步骤是对用于将薄片或薄膜成形为袋状的一个金属模具、与该金属模具对应的另一金属模具、以及插入到端口构件中空部分中的芯部金属施加高频率电压的步骤。
6.如权利要求1到3任一项记载的医疗用容器的制造方法，其中位于所述暂时固定部的薄片或薄膜由透明体或半透明体形成，端口构件的熔接部分的遮光率为50％～100％。
7.如权利要求6记载的医疗用容器的制造方法，其中所述薄片或薄膜由单层或多层结构形成。
8.如权利要求1到3任一项记载的医疗用容器的制造方法，其中所述热塑性树脂为不含极性基的热塑性树脂。
9.如权利要求1到3任一项记载的医疗用容器的制造方法，其中所述热塑性树脂为聚乙烯、聚丙烯、聚丁烯、聚丁二烯、聚异戊二烯、聚-4-甲基戊烯-1、聚苯乙烯、聚醋酸乙烯酯、聚甲基丙烯酸甲酯、聚甲基丙烯酸乙酯、聚丙烯酸、环状聚烯烃、聚丙烯腈、聚酰胺、聚酯、聚氨酯、聚碳酸酯、聚酰亚胺或聚苯硫醚的均聚物。
10.如权利要求1到3任一项记载的医疗用容器的制造方法，其中所述热塑性树脂为热塑性弹性体和/或包含该热塑性弹性体的共混聚合物。
11.如权利要求1到3任一项记载的医疗用容器的制造方法，其中所述热塑性树脂为包含乙烯-丙烯共聚物、乙烯-丁烯共聚物、乙烯-己烯共聚物、乙烯-辛烯共聚物的乙烯-α-烯烃共聚物、乙烯-醋酸乙烯酯共聚物、乙烯-醋酸乙烯酯共聚物的皂化物、乙烯-丙烯酸共聚物、乙烯-丙烯酸乙酯共聚物、乙烯-甲基丙烯酸甲酯共聚物、乙烯-马来酸酐共聚物、离聚物、由以苯乙烯或乙烯为主成分的部分与丁二烯或异戊二烯所形成的部分构成的嵌段共聚物、聚酰胺-聚醚嵌段共聚物、聚酯-聚醚嵌段共聚物、聚酯-聚酯嵌段共聚物、聚醚类或聚酯类、聚碳酸酯类的聚氨酯弹性体。
12.如权利要求1到3任一项记载的医疗用容器的制造方法，其中所述热塑性树脂由嵌段共聚物与选自聚丙烯、聚乙烯或聚丁烯中的至少一种获得的共混聚合物形成，所述嵌段共聚物是由以苯乙烯和/或乙烯为主成分的部分与丁二烯、异戊二烯、或这些物质的加氢物中的至少一种形成的部分构成的嵌段共聚物。
13.如权利要求7记载的医疗用容器的制造方法，其中所述多层结构是容器最内层由选自聚酰胺弹性体、聚酯弹性体、聚氨酯弹性体中的热塑性弹性体和/或包含这些弹性体的共混聚合物形成的。
14.如权利要求7记载的医疗用容器的制造方法，其中所述医疗用容器至少为：容纳血液和血液成分的袋子；容纳体液的袋子；输液袋；容纳直接给予中心静脉用的营养成分的袋子；容纳经肠给药营养剂的袋子或者容纳各种药液的袋子中的任何一种袋子。
15.采用权利要求13记载的医疗用容器制造方法制造的医疗用容器。
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