CN102555296A - 医疗用袋的制造方法和医疗用袋 - Google Patents
医疗用袋的制造方法和医疗用袋 Download PDFInfo
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- B29C66/80—General aspects of machine operations or constructions and parts thereof
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- B29C66/832—Reciprocating joining or pressing tools
- B29C66/8322—Joining or pressing tools reciprocating along one axis
- B29C66/83221—Joining or pressing tools reciprocating along one axis cooperating reciprocating tools, each tool reciprocating along one axis
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Abstract
本发明提供一种医疗用袋的制造方法和用所述医疗用袋的制造方法制造的医疗用袋,所述医疗用袋的制造方法在制造具有袋主体和口部形成部件的医疗用袋时,能够确实地将袋主体和口部形成部件液密性地接合在一起。医疗用袋的制造方法是在软质的袋主体(2)的缘部开口而设置的口部(23)上安装硬质的口部形成部件(3)来制造医疗用袋的方法,所述软质的袋主体用第1树脂材料构成并形成袋状,所述硬质的口部形成部件用第2树脂材料构成。该方法包括下述工序:第1加热工序,将口部形成部件(3)插入到袋主体(2)的口部(23)中,在该状态下将口部(23)加热至低于第1树脂材料熔点的温度,对口部23赋予形状以使口部(23)追随口部形成部件(3)的外形形状;和第2加热工序,以高于第1树脂材料熔点的温度加热口部(23),将口部形成部件(3)熔接在口部(23)上。
Description
技术领域
本发明涉及一种医疗用袋的制造方法和医疗用袋。
背景技术
作为医疗用袋,已知通过将树脂性片材熔接,从而在内部密封有输液用制剂或腹膜透析液等液体的医疗用袋。树脂性片材的熔接一般是通过将两片片材重叠,用一对密封模具夹持并加热来进行的。此时,在两片片材间配置成为液体的例如排出口的管状的端口部件,连同该端口部件一起进行熔接。由此,各片材和端口部件接合在一起(例如,参见专利文献1)。
但是,在将各片材和端口部件熔接时,如果一下子将各片材加热至其熔点,则片材的熔接部急剧地过度变形,在该熔接部产生针孔或产生其壁厚极薄的部分。若存在针孔,则气体阻隔性受损,例如空气中的水分、氧、二氧化碳等侵入袋中,有时使医疗用袋内的药剂变质。而且,若片材的壁厚部分地变得极薄,则在对医疗用袋施加下落等冲击时,医疗用袋易于破袋等。
专利文献1:日本特公平6-38829号公报
发明内容
本发明的目的在于提供一种在制造具有袋主体和口部形成部件的医疗用袋时能够确实地将袋主体和口部形成部件液密性地接合在一起的医疗用袋的制造方法、和用所述医疗用袋的制造方法制造的医疗用袋。
这样的目的是通过下述(1)~(11)的本发明达成的。
(1)一种医疗用袋的制造方法,其是在软质的袋主体的缘部开口而设置的口部上安装硬质的口部形成部件来制造医疗用袋的方法,所述软质的袋主体用第1树脂材料构成并形成可容纳液体的袋状,所述硬质的口部形成部件用第2树脂材料构成并用于使上述液体通过,其特征在于,该制造方法包括下述工序:
第1加热工序,将上述口部形成部件插入到上述袋主体的上述口部中,在该状态下将上述口部加热至低于上述第1树脂材料熔点的温度,对上述口部赋予形状以使上述口部追随上述口部形成部件的外形形状;和
第2加热工序,以高于上述第1树脂材料熔点的温度加热上述口部,将上述口部形成部件熔接在上述口部上。
(2)如上述(1)所述的医疗用袋的制造方法,其中,上述第1加热工序的加热温度低于上述第2加热工序的加热温度。
(3)如上述(1)或(2)所述的医疗用袋的制造方法,其中,上述第1树脂材料和上述第2树脂材料分别指主材料为聚丙烯的树脂材料,
上述第1加热工序的加热温度为60~100度,上述第2加热工序的加热温度为150~190度
上述第1加热工序的加热时间和上述第2加热工序的加热时间分别为3.0~7.0秒。
(4)如上述(1)至(3)中任一项所述的医疗用袋的制造方法,其中,使用模具来分别进行上述第1加热工序和上述第2加热工序的加热。
(5)如上述(1)至(4)中任一项所述的医疗用袋的制造方法,其中,在上述第1加热工序之前包括部件加热工序,所述部件加热工序中将上述口部形成部件加热至高于上述第2树脂材料熔点的温度。
(6)如上述(5)所述的医疗用袋的制造方法,其中,上述第2树脂材料是主材料为聚丙烯的树脂材料,
上述部件加热工序的加热温度为190~230度,
上述部件加热工序的加热时间为2.0~6.0秒。
(7)如上述(1)至(6)中任一项所述的医疗用袋的制造方法,其中,在上述第2加热工序之后包括冷却工序,所述冷却工序中将上述口部冷却至低于上述第1树脂材料熔点的温度。
(8)如上述(7)所述的医疗用袋的制造方法,其中,上述第1树脂材料是主材料为聚丙烯的树脂材料,
上述冷却工序的冷却温度为60~90度,
上述冷却工序的冷却时间为3.0~7.0秒。
(9)如上述(1)至(8)中任一项所述的医疗用袋的制造方法,其中,上述口部形成部件具有形成管状的管状部和形成在该管状部的外周部并相互向反方向突出的突部。
(10)如上述(1)至(9)中任一项所述的医疗用袋的制造方法,其中,上述袋主体是将形成长片状的两片片材的缘部彼此接合在一起而形成的,
在上述片材的宽度方向的中央部形成上述口部。
(11)一种医疗用袋,其特征在于,是通过上述(1)至(10)中任一项所述的医疗用袋的制造方法制造的。
另外,本发明的医疗用袋的制造方法中,上述第1树脂材料和上述第2树脂材料优选为组成相同或不同的树脂材料。
另外,本发明的医疗用袋的制造方法中,上述第1树脂材料和上述第2树脂材料分别优选为热塑性弹性体。
另外,本发明的医疗用袋的制造方法中,上述第1加热工序的加热时间优选与上述第2加热工序的加热时间相同或比其更长。
根据本发明,在制造具有袋主体和口部形成部件的医疗用袋时,通过第1加热工序,袋主体的口部以不熔融的程度确实地发生热变形以追随口部形成部件的外形形状,从而对口部赋予形状。由此,通过第2加热工序将口部形成部件与口部熔接时,即使将口部加热至高于其熔点的温度,也可防止该口部急剧过度变形,例如产生针孔或产生其厚度极薄的部分,从而可确实地进行其熔接。这样熔接在一起的袋主体和口部形成部件形成液密性接合。于是,能够得到袋主体和口部形成部件液密性接合在一起的医疗用袋。
附图说明
图1是依次表示本发明的医疗用袋的制造方法中的各工序的立体简图。
图2是依次表示本发明的医疗用袋的制造方法中的各工序的立体简图。
图3是依次表示本发明的医疗用袋的制造方法中的各工序的立体简图。
图4是依次表示本发明的医疗用袋的制造方法中的各工序的立体简图。符号说明
1 医疗用袋
2 袋主体
21a、21b 片材
211 缘部
22 空间
23 口部
24 开口部
3 口部形成部件
31 管状部
311 扩径部
312 管路
32 突部
321 突片
4A、4B、4C 模具
41a 上侧模具
41b 下侧模具
42 面
421 凹部
43 内腔
44 加热器
11 液体
具体实施方式
以下,基于附图中给出的优选实施方式详细说明本发明的医疗用袋的制造方法和医疗用袋。
图1~图4分别是依次表示本发明的医疗用袋的制造方法中的各工序的立体简图。另外,以下,为了方便说明,将图1~图4中的左侧称为“基端”,将右侧称为“前端”,将上侧称为“上”或“上方”,将下侧称为“下”或“下方”。
通过图1~图4所示的医疗用袋的制造方法制造的医疗用袋1具备袋主体2和口部形成部件3,在袋主体2内填充有液体11。需要说明的是,作为医疗用袋1,既可以为袋主体2的内部被划分为多个空间的多室容器,也可以为具有1个空间22的单室容器。本实施方式中,举出单室容器作为一例进行说明。
如图4所示,袋主体2由平面观察下大小相同的形成大致长方形(长片状)的片材21a、21b构成,将片材21a、21b的缘部211彼此接合形成袋状。于是,在片材21a与片材21b之间的空间22能够容纳液体11。需要说明的是,作为片材21a、21b彼此的接合方法,没有特别限定,可举出例如基于熔接(热熔接、高频熔接、超声波熔接等)的方法、基于粘接(利用接合剂或溶剂进行的粘接)的方法等。
片材21a、21b分别为软质材料,即具有挠性,用第1树脂材料构成。对于该构成材料在后文进行叙述。
如图2所示,在袋主体2的前端侧的缘部、即前端部不将片材21a与片材21b接合在一起,而是设置开口的口部23。该口部23形成用于安装口部形成部件3的部分。
另外,口部23的形成位置优选设定为片材21a、片材21b的宽度方向的中央部。由此,在形成口部23时,与其形成位置设定在例如片材21a、片材21b的拐角部的情况相比,设定在上述中央部的情况下较容易形成该口部23。并且,在口部23安装口部形成部件3时,口部形成部件3向口部23的插入操作变得容易。并且,还具有排出内溶液(液体11)时医疗用袋1内的残液少的优点。
作为容纳在这种构成的袋主体2的空间22中的液体11,没有特别限定,可举出例如腹膜透析液、生理盐水、电解质溶液、林格氏液、高热量输液制剂、葡萄糖液、注射用水、经口营养剂等。
如图1所示,口部形成部件3具有形成管状的管状部31、和突出地形成在管状部31的外周部的突部32。
管状部31作为液体11在其管路312中通过的流路发挥功能。由此,能够从袋主体2将液体11排到外部,或能够将来自其他容器的液体注入袋主体2中进行混合。优选在管路312上配置有开关该管路312的阀体(未图示)。
需要说明的是,在图示的构成中,在管状部31的前端外周部形成有外径扩大了的扩径部311,但不限于此,例如也可以省略扩径部311。
另外,在管状部31的基端外周部形成有突部32。该突部32由相互向反方向突出的一对突片321构成。并且,突部32的上面和下面以分别隆起的方式弯曲,整体形状形成船形。而且,如果将突部32插入袋主体2的口部23,则用片材21a和片材21b能够夹持突部32,能够以该夹持状态将突部32接合固定在口部23上。这样,突部32作为用于接合固定在口部23上的固定部发挥功能。
如上所述,片材21a、21b分别是软质的,用第1树脂材料构成。另一方面,口部形成部件3是硬质的,用第2树脂材料构成。并且,第2树脂材料的熔点比第1树脂材料的熔点高。
作为第1树脂材料和第2树脂材料,分别可举出含有下述物质作为其主材料的材料:例如聚丙烯、聚乙烯、聚丁二烯、乙烯-乙酸乙烯酯共聚物这样的聚烯烃、烯烃类弹性体、苯乙烯类弹性体等各种热塑性弹性体或它们的任意组合物(混合树脂、聚合物合金、层积体等),特别优选含有聚丙烯作为主材料的材料。例如从具有耐受高压蒸气灭菌的耐热性、耐水性的方面考虑,优选上述树脂材料。此处,“主材料”是指在树脂材料整体中所占的比例为50%以上的材料。
而且,医疗用袋1中,通过选择片材21a、21b的材质(构成材料的聚合物组成、分子量、可塑材等添加剂)、片材21a、21b的厚度等条件进行适宜组合,能够将片材21a、21b设定为软质的片材。
与此相同,通过选择口部形成部件3的材质(构成材料的聚合物组成、分子量、可塑材等添加剂)、口部形成部件3的管状部31的管壁厚度等条件进行适宜组合,能够将口部形成部件3设定为硬质部件。
另外,为了有效防止液体11的变质和劣化,优选片材21a、21b的气体透过性尽可能低,也就是具有气体阻隔性。
接下来,参照图1~图4对医疗用袋的制造方法进行说明。该医疗用袋的制造方法是在袋主体2的口部23安装口部形成部件3来制造医疗用袋1的方法,包括部件加热工序、第1加热工序(预加热工序)、第2加热工序(主加热工序)、冷却工序和液体填充工序。在此,将构成袋主体2的第1树脂材料和构成口部形成部件3的第2树脂材料分别设定为上述的以聚丙烯作为主材料的材料,进行说明。
其中,部件加热工序中使用模具4A,第1加热工序中使用模具4B,第2加热工序中使用模具4C(参照图1~图3)。各模具4A~4C具备相互对置配置的、可接近和分离的上侧模具41a和下侧模具41b。上侧模具41a和下侧模具41b的形状相同,因而以下代表性地说明上侧模具41a。
上侧模具41a用形成四棱柱状的部件构成,并以其长度方向与水平方向平行的方式配置。在上侧模具41a的面对下侧模具41b的面42上,在其长度方向的中央部形成有凹部421。该凹部421的底面形成与口部形成部件3的突部32的弯曲成上述隆起方式的上面对应的、也就是与上述上面大致同样的弯曲形状。
另一方面,下侧模具41b是使与上侧模具41a同样的模具上下反转后配置在上侧模具41a的下方而形成的。
于是,在上侧模具41a和下侧具41b接近后的合模状态,在上侧模具41a的凹部421与下侧模具41b的凹部421之间形成内腔43。
另外,在上侧模具41a、下侧模具41b中分别内置有用例如电热线构成的加热器44。由此,各模具4A~4C分别在合模状态可进行加热。
[1]部件加热工序
如图1所示,将模具4A设定为上侧模具41a与下侧模具41b相互分离的开模状态,在上侧模具41a与下侧模具41b之间配置口部形成部件3的突部32。接下来,将模具4A设定为合模状态。由此,在上侧模具41a与下侧模具41b之间夹住突部32,即在内腔43内配置突部32。
然后,直接在该状态下使加热器44工作,将口部形成部件3加热至比作为其构成材料的第2树脂材料的熔点高的温度。作为加热温度,没有特别限定,然而例如优选为190~230度,更优选为200~220度。
另外,加热时间根据加热温度而不同,但在该加热温度为上述数值范围时,加热时间例如优选为2.0~6.0秒,更优选为3.0~5.0秒。
通过如上所述进行加热,口部形成部件3、特别是突部32被充分加热为少许熔融的程度。
[2]第1加热工序
接着,将模具4A设定为开模状态,将口部形成部件3脱模。其后迅速地、即在上述经充分加热的口部形成部件3未冷却以前如图2所示将该口部形成部件3插入到袋主体2的口部23中。然后,将插入有口部形成部件3的袋主体2载置在预先设定为开模状态的模具4B上。其后,将模具4B设定为合模状态。由此,口部形成部件3连同袋主体2一起被模具4B夹持(参照图2)。并且,此时,在口部形成部件3的突部32的上面,片材21a的构成口部23的部分被向下方挤压,在口部形成部件3的热的作用下发生热变形并贴在突部32的上面。与此相同,在突部32的下面,片材21b的构成口部23的部分也被向上方挤压,在口部形成部件3的热的作用下发生热变形,进行类似熔接。
需要说明的是,本工序中准备的袋主体2形成有其基端部尚未熔接的开口部24。开口部24在液体填充工序中填充液体11时使用。
接着,直接在该状态下使加热器44工作,将口部23加热至低于作为其构成材料的第1树脂材料的熔点的温度。作为其加热温度,没有特别限定,但例如优选为60~100度,更优选为70~90度。该加热温度优选低于下一工序即第2加热工序的加热温度。
另外,加热时间也根据本工序的加热温度的不同而不同,但该加热温度在上述数值范围时,加热时间例如优选为3.0~7.0秒,更优选为4.0~6.0秒。在各工序的模具相同时,该加热时间优选与第2加热工序的加热时间相同,在各工序的模具不同时,该加热时间优选与第2加热工序的加热时间相同或比其更长。
通过上述加热和上述的片材21a、21b分别贴在口部形成部件3的突部32上的协同效应,口部23以追随口部形成部件3的突部32的外形形状的方式确实地发生变形。由此,能够对口部23赋予形状。另外,在进行该形状赋予时,由于本工序的加热是直至低于第1树脂材料的熔点的温度为止的加热,所以当然没有达到口部形成部件3与口部23熔接的程度。
而且,通过对口部23实施形状赋予,在通过第2加热工序将口部形成部件3与口部23熔接时,即使将口部23加热至高于其熔点的温度,也可确实地防止该口部23急剧过度变形,因而可确实地进行其熔接。
[3]第2加热工序
接下来,将模具4B再次设定为开模状态,将口部形成部件3经类似熔接后的袋主体2脱模。
接着,将口部形成部件3经类似熔接后的袋主体2载置在预先设定为开模状态的模具4C上。其后,如图3所示,将模具4C设定为合模状态。然后,在将口部形成部件3连同袋主体2一起夹在模具4C中的状态下,使加热器44工作,将口部23加热至高于第1树脂材料的熔点的温度。
作为本工序的加热温度,没有特别限定,但例如优选为150~190度,更优选为160~180度。
另外,加热时间也根据本工序的加热温度的不同而不同,但该加热温度在上述数值范围时,加热时间例如优选为3.0~7.0秒,更优选为4.0~6.0秒。
通过上述加热,口部23熔融达到可防止例如产生针孔或产生其厚度极薄的部分的程度。由此,能够确实地将口部形成部件3与口部23熔接,因而,能够将口部23和口部形成部件3确实地液密性接合在一起。
[4]冷却工序
接下来,如图4所示,将模具4C设定为开模状态,将接合有口部形成部件3的袋主体2脱模。其后,将袋主体2的口部23冷却至低于第1树脂材料的熔点的温度。作为其冷却温度,没有特别限定,但例如优选为60~90度,更优选为70~80度。
另外,冷却时间也根据冷却温度的不同而不同,但该冷却温度在上述数值范围时,冷却时间例如优选为3.0~7.0秒,更优选为4.0~6.0秒。
通过上述冷却,能够将熔融状态的口部23强制性固化,迅速转移至下一工序。
另外,本工序的冷却既可以使用冷却用的装置进行,也可以通过自然冷却来进行。作为“冷却用的装置”,没有特别限定,例如可举出输送冷风的送风机。
[5]液体填充工序
接着,使用喷嘴(未图示)从袋主体2的开口部24填充液体11。其后,通过例如熔接(热熔接、高频熔接、超声波熔接等),封闭开口部24。由此,得到填充有液体11的医疗用袋1(参照图4)。于是,如上所述,该医疗用袋1的口部23和口部形成部件3确实地液密性接合在一起。
另外,液体11不限于从开口部24填充,例如也可以从口部形成部件3填充。
以上,针对图示的实施方式说明了本发明的医疗用袋的制造方法和医疗用袋,但本发明不限于此,构成医疗用袋的各部能够与可发挥同样功能的任意构成物置换。并且,也可以添加任意的构成物。
另外,部件加热工序、第1加热工序、第2加热工序的加热是使用不同的模具进行的,但不限于此,例如也可以使用1个模具进行加热。
另外,部件加热工序、第1加热工序、第2加热工序的加热是使用模具进行的,但不限于此,例如也可以使用吹热风的干燥机、卤素灯进行加热。
Claims (11)
1.一种医疗用袋的制造方法,是在软质的袋主体的缘部开口而设置的的口部上安装硬质的口部形成部件来制造医疗用袋的方法,所述软质的袋主体用第1树脂材料构成并形成可容纳液体的袋状,所述硬质的口部形成部件用第2树脂材料构成并用于使所述液体通过,其特征在于,所述制造方法包括下述工序:
第1加热工序,将所述口部形成部件插入到所述袋主体的所述口部中,在所述状态下将所述口部加热至低于所述第1树脂材料熔点的温度,对所述口部赋予形状以使所述口部追随所述口部形成部件的外形形状;和
第2加热工序,以高于所述第1树脂材料熔点的温度加热所述口部,将所述口部形成部件熔接在所述口部上。
2.如权利要求1所述的医疗用袋的制造方法,其中,所述第1加热工序的加热温度低于所述第2加热工序的加热温度。
3.如权利要求1或2所述的医疗用袋的制造方法,其中,所述第1树脂材料和所述第2树脂材料分别指主材料为聚丙烯的树脂材料,
所述第1加热工序的加热温度为60~100度,所述第2加热工序的加热温度为150~190度,
所述第1加热工序的加热时间和所述第2加热工序的加热时间分别为3.0~7.0秒。
4.如权利要求1至3中任一项所述的医疗用袋的制造方法,其中,使用模具来分别进行所述第1加热工序和所述第2加热工序的加热。
5.如权利要求1至4中任一项所述的医疗用袋的制造方法,其中,在所述第1加热工序之前包括部件加热工序,所述部件加热工序中将所述口部形成部件加热至高于所述第2树脂材料熔点的温度。
6.如权利要求5所述的医疗用袋的制造方法,其中,所述第2树脂材料是主材料为聚丙烯的树脂材料,
所述部件加热工序的加热温度为190~230度,
所述部件加热工序的加热时间为2.0~6.0秒。
7.如权利要求1至6中任一项所述的医疗用袋的制造方法,其中,在所述第2加热工序之后包括冷却工序,所述冷却工序中将所述口部冷却至低于所述第1树脂材料熔点的温度。
8.如权利要求7所述的医疗用袋的制造方法,其中,所述第1树脂材料是主材料为聚丙烯的树脂材料,
所述冷却工序的冷却温度为60~90度,
所述冷却工序的冷却时间为3.0~7.0秒。
9.如权利要求1至8中任一项所述的医疗用袋的制造方法,其中,所述口部形成部件具有形成管状的管状部和形成在所述管状部的外周部并相互向反方向突出的突部。
10.如权利要求1至9中任一项所述的医疗用袋的制造方法,其中,所述袋主体是将形成长片状的两片片材的缘部彼此接合在一起而形成的,
在所述片材的宽度方向的中央部形成所述口部。
11.一种医疗用袋,其特征在于,是通过权利要求1至10中任一项所述的医疗用袋的制造方法制造的。
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