CN100506661C - 多室容器的可剥离密封件 - Google Patents
多室容器的可剥离密封件 Download PDFInfo
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- CN100506661C CN100506661C CNB2003801015659A CN200380101565A CN100506661C CN 100506661 C CN100506661 C CN 100506661C CN B2003801015659 A CNB2003801015659 A CN B2003801015659A CN 200380101565 A CN200380101565 A CN 200380101565A CN 100506661 C CN100506661 C CN 100506661C
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Abstract
本发明提供一种用于包括第一边缘和第二边缘的多室容器的可剥离密封。第一边缘和第二边缘中的至少一个包括压力承受部分和非压力承受部分。
Description
技术领域
本发明涉及用于输送液体的容器。特别涉及多室容器的室之间的可剥离的密封件,该多室容器分别储存两种或者多种用于病人的药物成分。药物成分可以是粉末或者液体形式,并且通常是混合在一起形成治疗溶液。这样的溶液可以包括静脉注射溶液、营养溶液、麻醉药物溶液、肠溶液、母液、透析溶液,药理学试剂包括基因制剂和化学制剂,和很多其它可以给病人用药的液体。
背景技术
由于稳定性、兼容性或者其它关系,一些药物溶液在给病人用药之前必须分离储存。这些溶液可以存储在分离的容器中,但是通常储存在单一容器的分离的室中。室和溶液通常由易碎的热密封件分开。在美国专利第5209347;5176634;和4608043中公开了这样的容器的例子。这些现有技术的容器具有易碎的密封件以允许密封件被弄破,通过用手挤压袋子的侧面迫使容纳物弄破密封件并允许成分之间相互混合。可剥离的密封件是所使用的易碎密封件之一:通过拉扯容器的相对两侧或者通过挤压容器的侧壁,易碎密封件允许密封件分离。
分室的容器通常由柔性的聚合物材料制成。大量的聚合物膜被开发出来用于这样的容器,并且能够是单层结构或者是多层结构。单层结构能够由单一聚合物或者共混聚合物制成。多层结构能够由混合挤压(共挤出法coextrusion),挤压层压(extrusion lamination),层压(lamination),或者其它适合的方法形成。多层结构能够包括这样一些层:溶液接触层,防刮层,防止氧气或者水汽透过的阻挡层,复合薄膜粘接层(tie layer),或者其它层。适合的膜的选择依据容器中要装的溶液。
通常通过对齐(in registration)边缘部分放置一层或者多层聚合物薄膜片,并且密封外周边以形成密封的袋来形成容器。周边密封件是永久性的,因此不剥离。薄膜片通过热封,射频密封,热传导焊接,粘合密封,溶剂粘合,以及超声波或者激光焊接被密封。
吹胀挤塑是另外一种用来制造袋子的方法。吹胀挤塑是提供挤出物的移动管退出挤压模的过程。受压的空气使管子膨胀。管的纵向端被密封以形成袋子。吹胀挤塑过程只需要沿着两个外围表面的密封,但是单层或者多层膜片的对齐方法需要沿着一个,三个,或者四个外围表面的密封以形成袋子。
具有比外围密封件的剥离强度低的可剥离密封件能够通过各种方法在容器中形成,例如使用比用于形成外围密封件的加热密封温度低的加热密封温度。可剥离密封件通常具有必要的初始剥离力度或者峰值剥离力度以开始可剥离密封件的分离,以及扩大分离的平稳的剥离力度。蒸汽消毒之前,这些力基本上相等。在多室的容器填充溶液之后,通常在121℃的温度被蒸汽消毒。在蒸汽消毒时,压力(stress)施加在可剥离密封件的边缘。当消毒时在高于容器材料的软化点温度向可剥离密封件施加压力时,在密封件的边缘发生变形。变形减少了密封件边缘的应力集中,增加了开始剥离可剥离密封件的必要的峰值剥离力度。在蒸汽消毒之后,峰值剥离力度能够比平稳状态的剥离力度明显的大。增加的峰值剥离力度对于多室容器的使用不利,它使得为了打开容器的开始剥离更困难。这对于使用医药溶液的病人,可能是虚弱的或者年老的并且不能提供必须的开始剥离的力量的病人,是特别真实的。此外,峰值剥离力度难以控制,一些容器的可剥离密封件的开始剥离仍然容易,而另一些变得用手开始剥离几乎是不可能的。
发明内容
本发明提供了一种包括第一侧壁和第二侧壁的多室的容器。第一侧壁和第二侧壁沿着共同的周边被密封。它也包括连接第一侧壁和第二侧壁以便在容器中形成室的可剥离密封件。可剥离密封件具有长度,和至少沿着其长度的一部分的锯齿形部分。
在另一个实施例中,本发明提供了一种包括第一侧壁和第二侧壁的多室的容器。第一侧壁和第二侧壁沿着共同的周边被密封。它也包括一对连接第一侧壁和第二侧壁以便在容器中形成室的可剥离密封件。这对密封件包括第一密封件和第二密封件。第一密封件具有第一剥离力,第二密封件具有第二剥离力。第一剥离力小于第二剥离力。
在另一个实施例中,本发明提供了包括第一侧壁和第二侧壁的一种多室的容器。第一侧壁和第二侧壁沿着共同的周边被密封。可剥离的密封件连接第一侧壁和第二侧壁以便在容器中形成室。可剥离密封件具有外边缘和中心部分。可剥离密封件还具有剥离力梯度,这样外边缘的剥离力小于中心部分的剥离力。
在另一个实施例中,本发明提供了一种剥离具有可剥离密封件的容器的方法。该方法包括以下步骤:提供了一种容器,其具有第一侧壁,第二侧壁以及连接第一侧壁和第二侧壁的可剥离密封件。可剥离密封件至少沿着其长度的一部分具有锯齿状部分。锯齿状部分具有外点,内点,以及连接外点和内点的角状引脚(angular leg)。该方法还包括分离第一侧壁和第二侧壁的步骤,这样第一侧壁和第二侧壁首先沿着内点分离。
在另外一个方面,本发明包括用于多室的可剥离密封件,该密封件包括第一边缘和第二边缘。第一边缘和第二边缘中的至少一个包括压力承受(stress bearing)部分和非压力承受(non-stress bearing)部分。
本发明提供了一种可剥离密封件,其的初始峰值剥离力小于或者等于扩展剥离所需要的平稳状态剥离力。它还提供了一种可控制的,可再生的峰值剥离力。本发明另外的特性和优点将在下面的本发明和附图的详细描述中被说明和看到。
附图说明
图1是根据本发明实施例的包括可剥离密封件的多室的容器的平面图。
图2是曲线图,示出可剥离密封件消毒前后的典型的力与位移对比的曲线。
图3是根据本发明的实施例的具有锯齿状边缘的可剥离密封件的剖面图。
图4是根据本发明的实施例的可剥离密封件的放大的顶视图。
图5是根据本发明的实施例的可剥离密封件消毒之后的剖面图。
图6是根据本发明的实施例的可剥离密封件的力与位移对比的曲线图。
图7是根据本发明的实施例的可剥离密封件的剖面图。
图8是图7的密封件的力与位移对比的曲线图。
图9是根据本发明的实施例的可剥离密封件的剖面图。
图10是根据本发明的实施例的可剥离密封件的示意性的平面图。
图11是根据本发明的实施例的可剥离密封件的示意性的平面图。
图12是根据本发明的实施例的可剥离密封件的示意性的平面图。
图13是根据本发明的实施例的可剥离密封件的示意性的平面图。
图14是根据本发明的实施例的可剥离密封件的示意性的平面图。
图15是根据本发明的实施例的可剥离密封件的示意性的顶视图。
图16是根据本发明的实施例的可剥离密封件的示意性的视图。
图17是根据本发明的实施例的可剥离密封件的示意性的视图。
图18是根据本发明的实施例的可剥离密封件的示意性的视图。
具体实施方式
图1示出与本发明有关的类型的分室的容器10的例子。容器10储存在给病人用药前必须分开而不能混合的成分。容器10具有沿着共同周边14密封的第一侧壁12和第二侧壁13。周边密封件14优选地通过热传导密封制造,但是可以通过粘接,射频密封,热传导焊接,溶剂粘合,超声波或者激光焊接,或者其它适合的方法制造。
周边密封件14可以具有扩展的部分16,扩展部分16包括用于从钩子或者其它装置(未示出)悬挂容器10的挖掉部分18。容器10还包括一个或者多个孔道20,可以从该孔道将容器10中容纳的溶液给病人用药。容器10还包括两个或者多个被可剥离密封件26分开的室22和室24,但是可以使用任何适合的数量的室。增加室的数量会增加制造室所需要的密封件。
可剥离密封件26连接容器10的第一侧壁12和第二侧壁13,并且优选地在容器周边或者周边密封件14的相对两侧之间延伸。可剥离密封件26具有边缘27和29。可剥离密封件26如图1和11所示沿着容器的长度尺寸延伸,但是也可以如图10所示沿着横向边缘延伸。或者,可剥离密封件26可以完全包含在第一侧壁12和第二侧壁13之内,并且不与周边密封件14的任何部分交叉(图13)。进一步预期可剥离密封件26能够从角,横向边缘,和纵向边缘开始延伸,并且在容器10的别的地方终止(图12和图14)。可剥离密封件26可以位于第一侧壁12和第二侧壁13之间的任何地方,依据需要的室22和24的相对尺寸。室22和24可以填充医药或者其它用于形成治疗溶液的成分,包括静脉注射溶液、营养溶液、麻醉药物溶液、肠溶液、母液、透析溶液,药理学试剂包括基因制剂和化学制剂,和很多其它可以给病人用药的液体。成分可以是液体,粉末,冻干的药片(lyophilizedtablet),或者其它适合的形式。可以使用任何传统的方法将成分引入容器10和室22和室24,例如通过用于室22和24的专用的进入口来输送。可剥离密封件26的边缘27和29与室22和24中的液体邻接。
容器10优选地由柔性的聚合物材料制成。大量的聚合物薄膜已经被开发出来用于容器上。容器薄膜可以是形成囊或者袋子的单层结构聚合物材料或者是多层结构聚合物材料。单层结构能够由单一聚合物或者共混聚合物制成。多层结构能够由混合挤压(共挤出法coextrusion),挤压层压(extrusion lamination),层压(lamination),或者其它适合的方法形成。多层结构能够包括这样一些层:溶液接触层,防刮层,防止氧气或者水汽透过的阻挡层,复合薄膜粘接层(tielayer),或者其它层。依据容器中要装的溶液选择适合的膜。适合的聚合物材料通常包括聚烯烃,聚酰胺,聚酯,聚丁二烯,苯乙烯的均聚物和共聚物,和碳氢化合物的共聚物。
密封层可以是同相聚合物,或者基质相聚合物系统。适合的同相聚合物包括聚烯烃和更优选的聚丙烯以及最优选的丙烯和乙烯的共聚物,如通过参考结合于此的EP 0875231所述。
适合的基质相聚合物系统具有至少两种成分。这两种成分能够被混和在一起或者能够在两级反应过程中被生产出来。通常,这两种成分具有不同的熔点。在其中一种成分是非晶体的情况下,它的玻璃态转化温度将低于另一种成分的熔点。适合的基质相聚合物系统的例子包括:一种成分是聚烯烃的均聚物或者共聚物,第二种成分是苯乙烯和碳氢化合物的共聚物。另一种适合的基质相聚合物系统包括聚烯烃的混和物,例如聚丙烯和聚乙烯,或者具有高全同立构指数(结晶的)的聚丙烯和低全同立构指数(非晶的)的聚丙烯,或者聚丙烯均聚物和丙烯与α烯烃的共聚物。
适合的聚烯烃包括通过聚合包含了从2到20个碳原子的α烯烃得到的均聚物和共聚物,并且更优选地是从2到10个碳原子。因此适合的聚烯烃包括丙烯,乙烯,丁烯-1,戊烯-1,4-甲基-1戊烯,己烯-1,庚烯-1,辛烯-1,壬烯-1,癸烯-1的聚合物和共聚物。最优选的聚烯烃是丙烯的均聚物或者共聚物,或者聚乙烯的均聚物或者共聚物。
适合的聚丙烯的均聚物可以具有非晶的,全同立构的,间同立构的,不规则的,半全同立构的,或者立构规正嵌段的立体化学。在本发明的更优选的形式中,聚丙烯具有从大约20焦耳/克到大约220焦耳/克的低熔解热,更优选的从大约60焦耳/克到大约160焦耳/克,最优选的从大约80焦耳/克到大约130焦耳/克。在本发明的优选形式中,对于聚丙烯的均聚物具有小于大约165℃的熔解温度也是需要的,更优选的是从大约130℃到大约160℃,最优选的是从大约140℃到大约150℃。在本发明的一个优选形式中,聚丙烯的均聚物使用单中心催化获得。
适合的丙烯共聚物通过将丙烯单体与具有2到20个碳原子的α烯烃聚合获得。在本发明更优选的形式中,丙烯与重量占大约1%到大约20%的乙烯共聚合,更优选的是从大约1%到大约10%,最优选的是重量占共聚物的2%到大约5%。丙烯和乙烯的共聚物可以是无规共聚物或者嵌段共聚物。
还可能使用聚丙烯与α烯烃共聚物的混合物,其中丙烯共聚物可以因α烯烃中的碳的数量而不同。例如,本发明预期丙烯和α烯烃共聚物的混合物,其中一个共聚物具有2个碳α烯烃而另一个共聚物具有4个碳α烯烃。还有可以使用从2到20个碳的α烯烃的任意组合,并且更优选的是从2到8个碳原子。因此,本发明预期丙烯和α烯烃的共聚物的混合物,其中第一和第二α烯烃具有下列碳的数目的组合:2和6,2和8,4和6,4和8。还预期在混合物中使用超过2种聚丙烯和α烯烃的共聚物。适合的聚合物可以使用catalloy过程获得。适合的乙烯均聚物包括那些具有密度超过0.915g/cc的,并且包括的低密度聚乙烯(LDPE),中密度聚乙烯(MDPE),和高密度聚乙烯(HDPE)。
适合的乙烯共聚物通过将乙烯单体与具有3到20个碳的α烯烃聚合而获得,更优选的是3到10个碳,最优选的是4到8个碳。对于乙烯的共聚物,希望具有由ASTM(美国材料试验协会)D-792测量的、小于大约0.915g/cc的密度,更优选的是小于大约0.910g/cc,更优选的是小于大约0.900g/cc。这样的聚合物通常指VLDPE(极低密度聚乙烯)或者ULPDE(超低密度聚乙烯)。优选地,乙烯α烯烃共聚物使用单中心催化生产,更优选地使用金属茂合物催化系统。与为人所知道的具有混合催化中心(mixture of catalysts sites)的Ziegler-Natta类型的催化剂相对比,单中心催化被认为具有单个的,空间和电子相等的催化位置。这样的单中心催化的聚乙烯α烯烃由DOW公司以AFFINITY的商品名称销售,由Dupont Dow公司以的商标名称销售,由Exxon公司以EXACT的商品名称销售。这些共聚物在这里有时被称为m-ULDPE。
适合的乙烯共聚物还包括乙烯和较低的烷基丙烯酸酯共聚物,乙烯和较低的烷基取代烷基丙烯酸酯聚合物,和乙烯醋酸乙烯酯共聚物,其醋酸乙烯酯含量占共聚物重量的大约8%到大约40%。术语“较低的烷基丙烯酸酯”指具有图表1中所阐明的分子式的共聚用单体:
图表1
R团指具有1到17个碳的烷基。这样,术语“较低的烷基丙烯酸酯”包括但是不限于丙烯酸甲酯,丙烯酸乙酯,丙烯酸丁酯和同类的材料。
术语“烷基取代烷基丙烯酸酯”指具有图表2中所阐明的分子式的共聚用单体:
图表2
R1和R2是具有1到17个碳的烷基,并且可以具有相同数量的碳或者不同数量的碳。这样,术语“烷基取代烷基丙烯酸酯”包括但是不限于甲基丙烯酸甲酯,甲基丙烯酸乙酯,乙基丙烯酸甲酯(methylethacrylate),乙基丙烯酸乙酯(ethyl ethacrylate),甲基丙烯酸丁酯,乙基丙烯酸丁酯(butyl ethacrylate),和同类的材料。
适合的聚丁二烯包括1,3丁二烯的1,2-和1,4-加成产物(这些全被称为聚丁二烯)。在本发明的更优选的实施形式中,聚合物是1,3丁二烯的1,2加成产物(这些被成为1,2聚丁二烯)。在本发明更为优选的形式中,所关心的聚合物是间同立构的1,2聚丁二烯,更为优选的是低结晶度,间同立构的1,2聚丁二烯。在本发明的优选形式中,低结晶度,间同立构的1,2聚丁二烯具有低于大约50%的结晶度,更优选的是低于大约45%的结晶度,更为优选的是低于大约40%的结晶度,更为优选的是结晶度从大约13%到大约40%,最优选的是从大约15%到30%。在本发明的优选形式中,低结晶度,间同立构的1,2聚丁二烯具有根据ASTM D3418测定的熔点温度,从大约70℃到大约120℃。适合的树脂包括那些由JSR(日本合成橡胶)销售,具有如下商品名称的树脂:JSR RB 810,JSR RB 820,和JSR RB 830。
适合的聚酯包括di or多羧酸和多羟基醇或者烯化氧的缩聚产品。在本发明的优选形式中,树脂是聚杰酯。适合的聚杰酯从起反应的1,4环己烷二甲醇(cyclohexane dimethanol),1,4环己烷二羧酸(cyclohexanedicarboxylic acid)和聚四甲基乙二醇醚(polytetramethylene glycolether)中获得,并且被总称为PCCE。适合的PCCE由Eastman公司以ECDEL的商品名称销售。适合的聚酯进一步包括聚酯合成橡胶,它是聚对苯二甲酸丁二酯的硬结晶段和软(非结晶)聚醚二醇的第二段的嵌段共聚物。这样的聚酯合成橡胶由Du Pont化学公司以的商品名称销售。
适合的聚酰胺包括那些从具有4到12个碳的内酰胺的开环反应中得到的产物。这组聚酰胺因此包括尼龙6,尼龙10,和尼龙12。可接受的聚酰胺还包括,从具有碳的数目在2到13之内的二胺的缩合反应中得到的脂族聚酰胺,从具有碳的数目在2到13之内的二酸的缩合反应中得到的脂族聚酰胺,从脂肪酸的二聚物(dimer fatty acide)的缩合反应得到的聚酰胺,和包括共聚物的酰胺。这样,适合的脂族聚酰胺包括,例如,尼龙66,尼龙6,10和脂肪酸的二聚物聚酰胺。
适合的苯乙烯和碳氢化合物(烃hydrocarbon)的共聚物包括苯乙烯和不同的取代苯乙烯,包括烷基取代苯乙烯和卤素取代苯乙烯。烷基族可以包括1到6个碳原子。取代苯乙烯的具体的例子包括α甲基苯乙烯,β甲基苯乙烯,甲苯乙烯,3-甲基苯乙烯,4-甲基苯乙烯,4-异丙基苯乙烯,2,4-二甲基苯乙烯,O-氯苯乙烯,p-氯苯乙烯,O-溴苯乙烯,2-氯-4-甲基苯乙烯,等等。苯乙烯是最优选的。
苯乙烯的碳氢化合物部分和碳氢化合物的共聚物包括共轭二烯。可以被使用的共轭二烯是那些包括4到大约10个碳原子的共轭二烯,更普遍的是4到6个碳原子。例子包括,1,3-丁二烯,2-甲基-1,3-丁二烯(异戊二烯),2,3-二甲基-1,3-丁二烯,氯丁二烯,1,3-戊二烯,1,3-己二烯,等等。这些共轭二烯的混合物也以使用,例如丁二烯和异戊二烯的混合物。优选的共轭二烯是异戊二烯和1,3-丁二烯。
苯乙烯和碳氢化合物的共聚物可以是嵌段共聚物,包括二段,三段,多段,和星形段。二段共聚物的具体例子包括苯乙烯-丁二烯,苯乙烯-异戊二烯,和其氢化衍生物。三段聚合物的具体例子包括苯乙烯-丁二烯-苯乙烯,苯乙烯-异戊二烯-苯乙烯,α-甲基苯乙烯-丁二烯-α-甲基苯乙烯,和α-甲基苯乙烯-异戊二烯-α-甲基苯乙烯及其氢化衍生物。
上述嵌段共聚物的可选择氢化作用通过各种所熟知的处理过程实现,包括在有催化剂参与情况下的氢化,催化剂例如雷内镍催化剂,贵金属如铂,钯等等,以及可溶解的过度金属催化剂。能使用的适合的氢化过程是这样的:包含二烯的聚合物或者共聚物熔解在惰性的碳氢化合物稀释剂中,例如环己胺,并且在有可溶解的氢化催化剂的参与情况下与氢反应而被氢化。这样的过程在美国专利号第3,113,986和4,226,952中描述,该专利的公开被引入本文以供参考并且作为本文的一部分。
特别有用的氢化的嵌段共聚物是氢化的苯乙烯-异戊二烯-苯乙烯嵌段共聚物,例如苯乙烯-(乙烯/丙稀)-苯乙烯嵌段聚合物。当聚苯乙烯-聚丁二烯-聚苯乙烯嵌段共聚物被氢化时,所产生的产物象规则的乙烯和1-丁烯(EB)的共聚物段。如同上面所提到的,当所使用的共轭二烯是异戊二烯时,所产生的氢化产物象规则的乙烯和丙稀(EP)的共聚物段。一个商业上可用的有选择氢化共聚物的例子是KRATONG-1652,它是氢化的SBS三段,包括30%的苯乙烯的两端的段,并且中段等价物是乙烯和1-丙稀(EB)的共聚物。这种氢化的嵌段共聚物通常被称为SEBS。其它适合的SEBS或者SIS共聚物由Kurrarry公司以和的商品名称销售。使用接枝改性的苯乙烯和碳氢化合物的嵌段共聚物也是所需要的,通过将α,β不饱和一元羧酸或者二元羧酸试剂接枝到上述选择氢化嵌段共聚物上得到这种接枝改性的嵌段共聚物。
共轭二烯和乙烯基芳烃化合物的嵌段共聚物被用α,β不饱和一元羧酸或者二元羧酸试剂接枝。羧酸试剂包括本身和其功能性衍生物,例如酐,酰亚胺,金属盐,酯,等等,这些能被接枝到选择氢化的嵌段共聚物上。接枝的聚合物通常重量占嵌段共聚物与接枝羧酸的羧酸试剂的总重量的大约0.1到20%,优选地占大约0.1到10%。有用的一元羧酸的具体例子包括,丙烯酸,甲基丙烯酸,苯丙烯酸(肉桂酸cinnamic acid),丁烯酸(巴豆酸crotonic acid),丙烯酸酐,丙烯酸钠,丙烯酸钙,丙烯酸镁,等等。二元羧酸和其有用的衍生物的例子包括,顺丁烯二酸,顺丁烯二酸酐,反丁烯二酸(富马酸fumaric acid),甲基反丁烯二酸,甲叉丁二酸,顺甲基丁烯二酸,亚甲基丁二酸酐,柠康酸酐,一甲基顺丁烯二酸酯(monomethyl maleate),顺丁烯二酸钠(monosodium maleate),等等。苯乙烯和碳氢化合物的嵌段共聚物可以用油改性,例如油改性的SEBS,由壳牌化学公司以KRATON G2705的商品名称销售。
通常通过对齐其周边部分放置一个或者多个聚合薄膜片,并且密封它们的周边14以形成密封的袋来形成容器10,这些聚合物薄膜片形成了第一侧壁12和第二侧壁13。薄膜片通常通过热封,射频密封,热传导焊接,粘合密封,溶剂粘合,以及超声波或者激光焊接被密封。吹胀挤塑是另外一种可以用来制造袋的方法。吹胀挤塑是提供挤出物的移动管退出挤压模的过程。受压的空气使管子膨胀。管的纵向端被密封以形成袋子。吹胀挤塑过程只需要沿着两个外围表面的密封,但是单层或者多层膜片的对齐方法需要沿着一个,三个,或者四个外围表面的密封以形成袋子。
可剥离的密封件26优选地通过加热密封制造,但是也可以通过任何上述的密封或者焊接方法,或者其它适合的方法制成。可剥离密封件26是可剥离的,这样它可以通过手的压力被剥离以便把第一侧壁12和第二侧壁13分离以便允许在第一室22和第二室24之间的流体连通,因而混合在它们中所容纳的成分。例如,通过抓住容器10的第一侧壁12和第二侧壁13,并且将它们撕开来剥离可剥离密封件26,或者通过挤压或压迫第一侧壁12和第二侧壁13,以便把室22和室24中的液体以足够的力量压到可剥离的密封件26上来分离可剥离密封件26。可剥离密封件26足够坚固以经受外部的压力,而不会因搬运,运输过程中的一般的挤压,或者偶然的坠落而导致被剥离。
容器通常被填充达到每平方英寸(psi)60磅的压力。在被充满溶液后,容器10通常使用蒸汽消毒。消毒通常发生在121℃的温度。
图2示出具有直边27和29的可剥离密封件26的通常的力与位移对比的曲线。图2的x轴示出沿着可剥离密封件26的长度的位移。y轴示出沿着可剥离密封件26的长度,在特定的点剥离可剥离密封件26所必须的力。曲线28是蒸汽消毒前力与位移对比的曲线。曲线30是蒸汽消毒之后力与位移对比的曲线。正如从图2的曲线28所能看到的,力32是蒸汽消毒之前开始剥离可剥离密封件26所必须的。力32与平稳状态的力34相同,平稳状态的力34是开始剥离之后扩展剥离所必须的。
如曲线30所示,蒸汽消毒之后,需要峰值剥离力36以便开始剥离可剥离密封件26。峰值剥离力36明显大于扩展剥离所必须的平稳状态的力40。峰值剥离力36由于消毒所产生。消毒能导致容器10的室22和室24中的溶液沸腾。沸腾能导致室22和室24中的液体膨胀,并且因此通过使第一侧壁12和第二侧壁13分开而进一步压迫第一侧壁12和第二侧壁13。当在温度高于容器材料的软化点温度施加压力在可剥离密封件26上时,密封边缘27和29的变形发生了。也能够因为水的膨胀,和/或者由于结晶化而引起的容器材料的收缩,或者在拉伸的容器薄膜,应力松弛的情况下,发生变形。变形减少了在密封边缘27和29处的应力集中,因此增加了弄破可剥离密封件26以便开始剥离过程所必须的力度。这个峰值剥离力36对不方便使用。此外,由于原因变化的性质,峰值剥离力36是变化的并且难以控制。一些密封件26或许太容易活动,在运输,普通搬运,或者坠落过程中被剥离。其它的密封件26变得几乎不可能用手开始剥离。
本发明通过减少在密封边缘27和29处开始剥离所必须的峰值剥离力36克服了这些问题。已经发现,从在可剥离密封件26的至少一部分上的直边改变密封边缘27或者29的形状能够达到这个目的,可剥离密封件26的至少一部分是指剥离开始的地方。这减少了在蒸汽消毒期间暴露在高温时经受压力的可剥离密封件26的长度。这样,峰值剥离力36仅仅发生在可剥离密封件26的有限的部分。
图3示出根据本发明的实施例的可剥离密封件42在蒸汽消毒之前的剖面图。容器的第一侧壁44和第二侧壁46在密封件42处被密封。密封件42限定了容器中的室48和50。
图4是图3的密封件42在蒸汽消毒之间的放大的顶视图。密封件42具有密封区52,第一密封边缘54,和第二密封边缘56。第一密封边缘54和第二密封边缘56是锯齿形的,具有外点58和角状引脚60,引脚60成一定角度地从外点58开始并且在外点58之间延伸。引脚60在内点62交叉,因此内点62与外点58连接。在内点62和外点58之间是深度63。虽然图4既示出锯齿形的第一密封边缘54又示出锯齿形的第二密封边缘56,但是根据本发明(图15),预计仅仅第一密封边缘54或者第二密封边缘56的一个或者另一个可以是锯齿形的。还预计锯齿状能够在密封件42的全部长度上存在,或者仅仅在所选择的部分存在。优选地锯齿状与容器10的周边密封件14是隔开的以允许剥离。
图5示出沿着与内点62交叉的图4的线76截取的,蒸汽消毒之后的密封件42的剖面图。如图5所示,在第一侧壁44和第二侧壁46之间的角状接合处77存在于内点62处,并且蒸汽消毒之后被保持。
图6是用于本发明的实施例的锯齿状的密封件42的力与位移对比的曲线。x轴示出沿着密封件42的长度的位移。y轴示出在沿着密封件42的长度的点上剥离密封件42所需要的力。曲线64是蒸汽消毒之前力与位移对比的曲线。初始力66对于开始剥离的扩展是必要的。这个力基本上与最大的扩展剥离的平稳状态的力68成线性增长。
图6还示出曲线70,曲线70示出用于蒸汽消毒之后锯齿状的剥离密封件42的力与位移的对比。曲线70示范了峰值剥离力72。峰值剥离力72大于消毒之前的初始力66,然而,它小于继续剥离过程所必须的最大扩展力74。这导致容器使用更方便,因为需要比以具有直的密封边缘的密封件更小的力开始剥离过程。
在消毒期间,仅仅外点58经受压力和变形,而不是内点62或者角状引脚60。因为薄膜的张力在外点58处最大,所以外点58经受压力。这样当密封42被制成时,存在的应力集中仅仅在外点58处被减少,而不是在角状引脚60或内点62处。应力集中因此保留在内点62处。
外点58限定了可剥离密封件42的外部压力承受区65。外点58承受由蒸汽消毒引起的压力。内点62和角状引脚60限定了密封件42的内部的非压力承受区67。压力承受区的建立也可以使用其它形状的密封边缘实现,例如圆齿状的密封边缘(图16和图18)或者梯形的密封边缘(图17),或者其它的多边形或者几何形状。
图16和图18中的压力承受区是圆齿71的顶部69。非压力承受区包括凹部73和圆齿71的斜边75。图17中的压力承受区由梯形79的平坦部分77建立。非压力承受区包括内点87和梯形79的侧边89。本发明还预计了其它建立压力承受区和非压力承受区的密封边缘形状。
在图4的锯齿状密封实施例中,容器的第一侧壁44和第二侧壁46在内点62处被首先分开。在内点62处的角状接合处77进一步促进第一侧壁44和第二侧壁46的分离。结果,峰值剥离力72低于用于扩展剥离密封件42的平稳状态的力74,力74是在内点62,引脚60,和外点58弄破密封件42所需要的各分力的总和。因为与密封件42的总长度相比,外点58的长度是小的,所以与内点62和引脚60相比,点58的贡献小于内点62和引脚60的贡献。因此,与具有直边27和29的密封件26相比,平稳状态的力74减小了。这通过允许使用者容易地开始剥离过程而改善了容器10的使用。它也改进了峰值剥离力72的重复性。然而密封件42足够坚固以保护密封件在通常的搬运过程中不被剥离。同样的,对于圆齿状的(图16和图18)和梯形的(图17)密封边缘,容器的侧壁在非压力承受区被开始分离,这样峰值剥离力低于平稳状态的力。
对于图4的锯齿状的密封边缘,减少峰值剥离力72的一个重要因素是锯齿的深度63。深度63控制剥离力曲线70达到平稳状态的数值74之前的斜率。深度63必须足够大以允许峰值剥离力72和平稳状态的力74之间的区别。用于减小峰值剥离力72的最小深度主要依据平稳状态的密封力74的数值,也就是说,对于较低的峰值剥离力,较大深度的63是必要的。其它因素包括,制造容器10的材料的机械特性,填充体积,填充压力,和消毒过程中产生的压力。体积越大,初始力越大,填充压力越大,初始力越大。每单位长度的锯齿的数量是决定峰值剥离力72减少的因素。锯齿的数量越多,峰值剥离力72越大。必须保持(struck)剥离力和密封件经受普通搬运的能力之间的平衡。经验指出,均匀的成90度的锯齿,8mm间隔的外点58,和4mm的深度63达到了可接收的峰值剥离力72。类似的,对于象是圆齿(图16和图18)或者梯形形状(图17)密封边缘的实施例,压力承受区和非压力承受区之间的深度必须被控制以保持剥离力和通常搬运之间的平衡。
在另一实施例中,本发明包括密封件78。图7示出蒸汽消毒前密封件78的剖面图。密封件78包括第一密封件80和第二密封件82。第二密封件82优选地位于第一密封件80的中央部分83。容器10具有第一侧壁81和第二侧壁85。密封件78将容器10的室88和90分开。第一密封件80也具有比第二密封件82低的剥离力。优选地,第一密封件的分离力大约是5N/15mm,同时第二密封件的分离力大约是15N/15mm。优选地通过热封第一侧壁81和第二侧壁85来建立密封件78,并且沿着密封件78改变温度,这样建立密封件82的温度高于建立第一密封件80的温度。这导致第一侧壁81和第二侧壁85在第二密封件82处比在第一密封件80处粘合在一起得更多。而这又需要比在第一密封件80处更大的力在第二密封件82处来分开第一侧壁81和第二侧壁85。第一密封件80具有第一边缘84和第二边缘86,它们每个分别与室88和室90中的液体接触。
图8示出用于密封件78的力与位移对比的曲线。曲线92示出在蒸汽消毒之前的力与位移的对比。曲线94示出在蒸汽消毒之后的力与位移的对比。如图8所示,在蒸汽消毒之后的初始的峰值力96仍然比第二密封件82的最大平稳状态的力98低。
当消毒时,在第一边缘84和第二边缘86将发生变形。这将增加第一密封件80的第一边缘84和第二边缘86处的剥离力。这样,即使在第一边缘84和第二边缘86处的峰值剥离力表现为第一密封件80的平稳状态的数值的三倍,它仍然低于分离在中央部分的第二密封件82所需要的剥离密封件的力。这样,在第二密封件82没有峰值剥离力产生。通过比在第一密封件80处更高的温度热封第二密封件82来建立密封件78。
根据类似的原则,在图9中所示的另一个实施例,密封件100具有沿着密封件100的宽度的剥离力梯度。密封件100具有第一边缘102和第二边缘104,和位于第一边缘102第二边缘104之间的中央部分106。在第一边缘102和第二边缘104处的剥离力小于,优选地大约三倍小于中央部分106处的剥离力。如同上面所述的密封件78,密封件100通过具有穿过其宽度的温度梯度的热封建立,中间的温度较高而边缘部分的温度较低。温度梯度可以获得,例如,通过具有被绝缘材料层分隔的加热元件的模具,并且其中心加热元件的温度高于边缘的温度。这样,当峰值剥离力发生在边缘102和104处时,它仍然低于中央部分106的剥离力。边缘102和104处的剥离力优选地大约是5N/15mm,而中央部分106处的剥离力大约是15N/15mm。以这种方式,即使密封件100的边缘102和104经历了三倍的剥离力的增长,它仍然小于或者等于中央部分106处的剥离力。这样,没有峰值剥离力发生。
应该理解对本文描述的当前优选实施例的各种变化和改动,对于本领域的专业人员是显而易见的。这样的变化和改动能够在不背离本分发明的精神和范围的情况下,和不减少本发明的预计优点的情况下做出。因此预计这样的变化和改动被附加的权利要求所覆盖。
Claims (11)
1.一种多室的容器包括:
第一侧壁和第二侧壁,第一侧壁和第二侧壁沿着共同的周边密封;
可剥离的密封件,连接第一侧壁和第二侧壁以在容器中形成室;并且
可剥离的密封件具有长度,可剥离的密封件至少沿着其长度的一部分具有锯齿状部分和非锯齿状部分,并且锯齿状部分的长度小于非锯齿状部分的长度。
2.如权利要求1所述的容器,其中可剥离的密封件在所述周边上的两点之间延伸。
3.如权利要求1所述的容器,其中可剥离的密封件具有第一边缘和第二边缘,并且其锯齿状部分位于第一边缘上或者位于第二边缘上。
4.如权利要求1所述的容器,其中可剥离的密封件具有第一边缘和第二边缘,并且锯齿状部分既位于第一边缘上又位于第二边缘上。
5.如权利要求1所述的容器,其中锯齿状部分与共同的周边隔开。
6.如权利要求1所述的容器,其中锯齿状部分包括内点,外点,连接内点和外点的角状引脚,以及内点和外点之间的深度。
7.如权利要求1所述的容器,其中容器的第一侧壁和第二侧壁在内点形成角状接合处。
8.一种多室的容器包括:
第一侧壁和第二侧壁,第一侧壁和第二侧壁沿着共同的周边密封;
具有相对的外部边缘部分的第一可剥离热密封件,第一可剥离热密封件沿着共同的长度与第二可剥离热密封件共同扩张,所述密封件连接第一侧壁和第二侧壁以在容器中形成室,第二可剥离热密封件位于外部边缘部分之间;
第一可剥离热密封件具有第一剥离力,第二可剥离热密封件具有第二剥离力;并且
其中第一剥离力小于第二剥离力。
9.如权利要求8所述的容器,其中可剥离的密封件在周边上的两个点之间延伸。
10.如权利要求8所述的容器,其中第一峰值剥离力是第二峰值剥离力的三分之一。
11.如权利要求8所述的容器,其中第二密封件位于第一密封件的中心。
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- 2002-10-17 US US10/273,825 patent/US7175614B2/en not_active Expired - Fee Related
-
2003
- 2003-10-14 BR BRPI0315426-2A patent/BR0315426B1/pt not_active IP Right Cessation
- 2003-10-14 AU AU2003284064A patent/AU2003284064B2/en not_active Ceased
- 2003-10-14 MX MXPA05003742A patent/MXPA05003742A/es active IP Right Grant
- 2003-10-14 DE DE60329311T patent/DE60329311D1/de not_active Expired - Lifetime
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- 2003-10-14 CA CA2501081A patent/CA2501081C/en not_active Expired - Fee Related
- 2003-10-14 AT AT07075469T patent/ATE490933T1/de not_active IP Right Cessation
- 2003-10-14 WO PCT/US2003/032216 patent/WO2004035419A1/en active Application Filing
- 2003-10-14 KR KR20057006499A patent/KR100987237B1/ko not_active IP Right Cessation
- 2003-10-14 CN CNB2003801015659A patent/CN100506661C/zh not_active Expired - Lifetime
- 2003-10-14 DE DE60335309T patent/DE60335309D1/de not_active Expired - Lifetime
- 2003-10-14 EP EP07075469.2A patent/EP1837291B9/en not_active Expired - Lifetime
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- 2003-10-14 AT AT03776295T patent/ATE443006T1/de not_active IP Right Cessation
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2006
- 2006-02-24 HK HK06102510.1A patent/HK1082485A1/xx not_active IP Right Cessation
- 2006-12-19 US US11/613,011 patent/US7546918B2/en not_active Expired - Lifetime
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ATE490933T1 (de) | 2010-12-15 |
KR20050053766A (ko) | 2005-06-08 |
CN1705594A (zh) | 2005-12-07 |
KR100987237B1 (ko) | 2010-10-12 |
CA2501081C (en) | 2012-02-07 |
DE60335309D1 (de) | 2011-01-20 |
US20040078023A1 (en) | 2004-04-22 |
US7175614B2 (en) | 2007-02-13 |
EP1551729A1 (en) | 2005-07-13 |
US20070088314A1 (en) | 2007-04-19 |
BR0315426B1 (pt) | 2014-06-24 |
US7546918B2 (en) | 2009-06-16 |
EP1837291B1 (en) | 2010-12-08 |
ATE443006T1 (de) | 2009-10-15 |
EP1837291A3 (en) | 2009-01-14 |
BR0315426A (pt) | 2005-08-16 |
CA2501081A1 (en) | 2004-04-29 |
MXPA05003742A (es) | 2005-06-17 |
JP2006502790A (ja) | 2006-01-26 |
EP1837291B9 (en) | 2013-06-19 |
EP1551729B1 (en) | 2009-09-16 |
AU2009201806A1 (en) | 2009-05-28 |
JP4558494B2 (ja) | 2010-10-06 |
EP1837291A2 (en) | 2007-09-26 |
WO2004035419A1 (en) | 2004-04-29 |
AU2003284064B2 (en) | 2009-06-04 |
DE60329311D1 (de) | 2009-10-29 |
HK1082485A1 (en) | 2006-06-09 |
AU2003284064A1 (en) | 2004-05-04 |
AU2009201806B2 (en) | 2010-09-09 |
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