CN109414564A - 用于长导管递送系统的混合密封托盘 - Google Patents
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Abstract
导管递送系统包装包括托盘、联接至托盘的延伸管、密封延伸管的端部的端盖和联接至托盘的盖子。该密封刚性托盘提供高度稳健的无菌屏障,且没有折叠和磨损。通过消除复合折叠,使得导管递送系统包装失效的可能性最小化。此外,导管递送系统包装具有减小的包装体积。此外,该导管递送系统包装是100%可回收的。
Description
相关申请
本申请要求由Jeffery Barnell于2016年7月6日提交的名称为“HYBRID SEALEDTRAY FOR LONG CATHETER DELIVERY SYSTEMS(用于长导管递送系统的混合密封托盘)”的美国临时申请第62/359,049号的权益,该文献通过参考全部纳入本文。
背景
技术领域
本申请涉及用于脉管内装置的包装和方法。更具体地,本申请涉及用于治疗脉管内疾病的装置的包装及相关方法。
背景技术
目前的商用导管递送产品系列利用单柔性袋或双柔性袋来形成无菌屏障。分离的热成形装置托盘将递送系统固定在袋内。这种方法对于具有该长度、总重量和重量分布的装置而言并不理想。操纵和递送期间的振动及冲击在屏障上施加显著应力。装置托盘会磨损内袋。袋的重复弯曲、特别是在多个(复合)折叠的汇合处会引起应力破裂和针孔。
考虑到每个装置在使用之前可能经历多个递送循环、例如来回运输,无菌屏障安全裕度可能低于优选值。目前的袋无菌屏障系统已显得非常难以开发以及通过验证测试来检验。
基于袋的无菌屏障会引起灭菌转移困难。护理人员已表示他们在将装置打开并呈现于无菌环境中存在困难。无菌袋十分接近地面向无菌表面使得污染的可能性高于理想值。用于打开并呈现装置的方法因护士和设施而异,其中一部分遭遇挫折且技术不良。
袋设计在空间和材料方面本质上是低效的。箱体必须设计得过大,从而导致过量材料使用、库存和运输费用。取决于应用,袋或托盘两者都不能被最终回收。
概述
用于容纳递送系统的导管递送系统包装包括托盘、联接至托盘的延伸管、密封延伸管的端部的端盖和联接至托盘的盖子。密封刚性托盘提供高度稳健的无菌屏障,且没有基于袋的系统中典型的折叠和磨损。通过消除复合折叠,使得导管递送系统无菌屏障失效的可能性最小化。此外,导管递送系统包装具有减小的包装体积。此外,与基于袋的系统不同,导管递送系统包装根据用途可能被100%回收。
导管递送系统包装的使用更好地确保了无交叉污染。因此,显著地改善了无菌屏障性能。使用导管递送系统包装来呈现并准备递送系统的整个程序是简易且快速的。
根据各种实施例的这些和其它特征将从以下结合附图提出的详细描述中变得更明显。
附图简介
图1是根据一个实施例的导管递送系统包装和架板箱的立体图。
图2是根据一个实施例的图1所示导管递送系统包装的分解立体图。
图3是根据一个实施例的图1和图2所示导管递送系统包装的托盘的俯视平面图。
图4是根据一个实施例的图1和图2所示导管递送系统包装的托盘的立体剖视图。
图5是根据一个实施例的图1和图2所示导管递送系统包装的端盖和延伸管的分解正视图。
图6是根据一个实施例的图5所示端盖和延伸管的分解后视图。
图7是根据另一实施例的图1和图2所示导管递送系统包装的端盖和延伸管的分解正视图。
图8是根据一个实施例的图7所示端盖和延伸管的分解后视图。
图9是根据一个实施例在打开期间的图1和图2所示导管递送系统包装的侧视立体图。
在全部附图和具体实施方式部分中使用相同的附图标记表示相同元件。
详述
作为概述,所呈现的是一种用于长导管递送系统的密封刚性托盘。该密封刚性托盘提供高度稳健的无菌屏障,且没有袋的折叠和磨损。在某些有限约束的情况下,一个托盘、盖子和箱体用于各种不同的递送系统。
灭菌呈现不仅简单又快速,而且还允许护士保持对递送系统的较好控制,由此使得污染最小化。托盘是100%可回收的,并且还使得包装和运输成本最小化。托盘设计是可适配的,从而使得可能支承其它长导管递送系统、例如Valiant EVO TAA成为可能。
现更具体地,图1是根据一个实施例的导管递送系统包装100和架板箱102、有时称作盒体的立体图。图2是根据一个实施例的图1所示导管递送系统包装100的分解立体图。图3是根据一个实施例的图1和图2所示导管递送系统包装100的托盘104的俯视平面图。图4是根据一个实施例的图1和图2所示导管递送系统包装100的托盘104的立体剖视图。
同时参考图1-4,导管递送系统包装100被输送或以其它方式包含于架板箱102内部。导管递送系统包装100包括托盘104、延伸管106、端盖108、盖子110、以及可选用的装置移除辅助卡板112。导管递送系统包装100是用于递送系统114的无菌屏障包装。递送系统114包括手柄116和从手柄116突出的突出部分118。递送系统114的示例包括Valiant EVOTAA系统,但在其它实施例中也可使用其它递送系统。
在一个实施例中,递送系统114包括一个或多个支架、移植物、支架移植物或用于在患者体内递送和植入的其它腔内装置。例如具有外护套的突出部分118根据一个实施例是圆柱形的,并且被构造成插入患者体内。突出部分118并不限于圆柱形构件,而是可根据其它实施例采取各种形状且具有各种特征。
托盘104、有时被称作共注塑本体是混合密封托盘。托盘104包括整体式盖子密封凸缘120,用于与盖子110密封。在托盘104中包含递送系统114的手柄116。在各种实施例中,托盘104使用注塑成形、吹塑成形和热成形来形成。
托盘104包括底表面122、近端124、侧面126、128和远端130。延伸管106联接至托盘104的远端130。侧面126、128和端部124、130向上远离底表面122延伸至盖子密封凸缘120。侧面126、128彼此相对且在近端124与远端130之间延伸。类似地,近端124和远端130彼此相对且在侧面126与侧面128之间延伸。
如本文中所使用的,递送系统114的远端被标示为离操作者(手柄116)最远的端部,而递送系统114的近端则是最接近操作者(手柄116)的端部。类似地,导管递送系统包装100的远端被标示为离托盘104(手柄116)最远的端部,而导管递送系统包装100的近端则是最接近托盘104(手柄116)的端部。
根据该实施例,盖子密封凸缘120是连续的平面表面。盖子密封凸缘120围绕托盘腔体132,该托盘腔体132由底表面122、近端124、侧面126、128和远端130所限定。盖子密封凸缘120包括连续的内边缘134和连续的外边缘136。盖子密封凸缘120在内边缘134与外边缘136之间具有均匀的厚度T。
在一个实施例中,托盘104包括抓持特征部138、有时被称作手柄,以有助于抓持托盘104。抓持特征部138是位于底表面122处的突出脊部。例如,在盖子110的移除期间,抓持特征部138允许使用者更紧地抓持托盘104并防止使用者的手滑落托盘104。
延伸管106密闭地焊接于托盘104。延伸管106是简易圆柱形挤出管,但在一个实施例中则是注塑成形的。延伸管106的尺寸适合于导管的长度,用于胸部装置时较长,而用于腹部装置时则较短。在其它实施例中,延伸管106是闭合轮廓,比如圆柱形、八边形、卵形或正方形。延伸管106可从一端渐缩至另一端,和/或例如取决于应用而沿其长度包括其它功能性特征部。在延伸管106中包含突出部分118。延伸管106包括近端140和远端142。
延伸管106的近端140安装于托盘104的远端130。更特别地,托盘104的远端130包括突出延伸管安装凸缘144。根据该实施例,延伸管安装凸缘144是圆柱形管。延伸管106的近端140滑动到延伸管安装凸缘144内部并接着焊接于延伸管安装凸缘144。
端盖108密闭地密封延伸管106的远端142。延伸管腔体146由延伸管106限定于延伸管106内,且在延伸管106的近端140与远端142之间延伸。延伸管腔体146与托盘腔体132敞开连通。
延伸管腔体146与托盘腔体132组合地限定递送系统腔体148,递送系统114放置在递送系统腔体148中且密封在无菌状态中。通常,递送系统腔体148是由托盘104、延伸管106、端盖108和盖子110所限定的无菌密封腔体。
更特别地,突出部分118通过托盘104滑动到延伸管106中。突出部分118滑动到延伸管106中,直至手柄116位于托盘104内为止。托盘104包括各种手柄安装特征部150,使得手柄116被压到托盘104中并压配、例如卡合到手柄安装特征部150中。在一个实施例中,装置移除辅助卡板112在手柄116之前或与手柄116一起插入托盘104中。通常,递送系统114放置在递送系统腔体148内。
在递送系统114放置在托盘104和延伸管106中之后,通过添附盖子110来形成无菌屏障,盖子110例如是密封的Tyvek(高密度聚乙烯合成纸)或其它柔性薄膜盖子。在一个实施例中,盖子110包括无纺高密度聚乙烯纤维。在一个实施例中,密封操作发生在工业标准密封机、例如热密封机上。盖子110包括突出凸片152,该突出凸片152向托盘104的近侧突出。如以下进一步论述的,突出凸片152有助于将盖子110从托盘104剥离。通常,突出凸片152从托盘104的近端124伸出。
使用粘合带将标签154附连至盖子110、托盘104和/或板架箱104。
在一个实施例中,高密度聚乙烯(HDPE)用于每个部件,以实现可靠的焊接和可回收性。在一个实施例中,每个组件对于屏障的完整性受到压力测试。通过消除与袋递送系统相关联的复合折叠,导管递送系统包装100失效的可能性大幅减小。
此外,导管递送系统包装100和相关联的箱体102与使用柔性袋相比具有减小的包装体积。这带来了可操作的节省成本的可能性。减小包装体积允许货板上有更多的装置,从而导致单个装置的更低的运输成本。包装材料成本还随着引入更简易的小架板箱和货主来减小。
图5是根据一个实施例的图1和图2所示导管递送系统包装100的端盖108和延伸管106的分解正视图。图6是根据一个实施例的图5所示端盖108和延伸管106的分解后视图。
如图5和6中所示,端盖108是例如用于电子束(e束)杀菌的实心端盖。根据该实施例,每个盖108包括突出的模制销502。更特别地,模制销502中限定密封延伸管接收腔体504。延伸管106的远端142插入模制销502中,且更特别地插入延伸管接收腔体504中。接着,模制销502被焊接于延伸管106,以密封延伸管106的远端142。
图7是根据另一实施例的图1和图2所示导管递送系统包装100的端盖108A和延伸管106的分解正视图。图8是根据一个实施例的图7所示端盖108A和延伸管106的分解后视图。如图7和图8中所示,端盖108A中具有开口706,以适应于环氧乙烷(EtO)的穿过,以供EtO杀菌。过滤件708、例如聚酯位于开口706上,以允许环氧乙烷穿过而阻挡病原体。
根据该实施例,每个盖108A包括突出的模制销702。更特别地,模制销702中限定延伸管接收腔体704。过滤件708定位在延伸管接收腔体704内,并覆盖延伸至延伸管接收腔体704的开口706。延伸管106的远端142插入模制销702中,且更特别地插入延伸管接收腔体704中。在一个实施例中,首先插入过滤件708,接着插入延伸管106的远端142,以将过滤件708在端盖108A与延伸管106之间压缩并固定。接着,模制销702被焊接于延伸管106,以密封延伸管106的远端142。
虽然图5-8示出了各种实施例,但考虑到合适的材料、设计和透气,除了EtO和e束杀菌之外,还支持多种形式的杀菌,比如,在其它实施例中是蒸气和伽玛杀菌。
图9是根据一个实施例在打开期间的图1和图2所示导管递送系统包装100的侧视立体图。如图9中所示,一旦没有架板箱102(参见图1),则巡回护士或其它使用者就例如借助抓持特征部138保持托盘104。接着,该护理人员抓持盖子110的突出凸片152并将盖子110从托盘104剥离,如图9中所示,以暴露递送系统114的近端、特别是手柄116。
手术助理护士或其它成员用一只手在无菌场中拉动装置移除辅助卡板112的提升凸片(如图2中所示)。装置移除辅助卡板112位于递送系统114与托盘104之间。相应地,牵拉装置移除辅助卡板112的提升凸片将递送系统114的手柄116提升远离托盘104。在一个实施例中,装置移除辅助卡板112伸出到盖子密封凸缘120上,由此将递送系统114与盖子密封凸缘120隔离。手术助理护士或其它使用者接着用另一只手将递送系统114拉离托盘104。
在另一实施例中,导管递送系统包装100不包括装置移除辅助卡板112。根据该实施例,在盖子110被剥开之后,手术助理护士或其它使用者伸入托盘104中并直接抓握递送系统114的手柄116。手术助理护士或其它使用者接着将递送系统114拉离托盘104。
导管递送系统包装100的使用更好地确保了没有交叉污染。相应地,在一个实施例中,无菌屏障性能显著改善,其中,无菌屏障性能是在盖子剥离之前闭合包装100的特征。整个过程可在短时间、例如8-10秒或更少时间内完成。这与可能花费60秒或更长时间的从袋移除形成对比。
此外,使用者、例如消费者喜欢导管递送系统包装100呈现和准备递送系统114的便利和速度。此外,在一个实施例中,导管递送系统包装100和箱体102是100%可回收的。
本公开提供了示例性实施例。范围不被这些示例性实施例所限制。本领域技术人员考虑到被公开可设想许多变型,比如结构、尺寸、材料类型和制造工艺的变型,而无论其是否由申请文件明确提供或由申请文件暗示。
Claims (20)
1.一种导管递送系统包装,包括:
托盘;
联接至所述托盘的延伸管;
密封所述延伸管的端部的端盖;以及
联接至所述托盘的盖子。
2.根据权利要求1所述的导管递送系统包装,其特征在于,所述托盘包括盖子密封凸缘。
3.根据权利要求2所述的导管递送系统包装,其特征在于,所述盖子密封凸缘是平面的。
4.根据权利要求3所述的导管递送系统包装,其特征在于,所述盖子密封凸缘包括连续的内边缘。
5.根据权利要求4所述的导管递送系统包装,其特征在于,所述盖子密封凸缘还包括连续的外边缘。
6.根据权利要求5所述的导管递送系统包装,其特征在于,所述盖子密封凸缘在所述内边缘与所述外边缘之间具有均匀的厚度。
7.根据权利要求1所述的导管递送系统包装,其特征在于,所述盖子包括无纺高密度聚乙烯纤维。
8.根据权利要求1所述的导管递送系统包装,其特征在于,所述盖子热密封于所述托盘。
9.根据权利要求1所述的导管递送系统包装,其特征在于,所述盖子包括从所述托盘的近端突出的凸片。
10.根据权利要求1所述的导管递送系统包装,其特征在于,所述延伸管的近端联接至所述托盘,并且所述端盖联接至所述延伸管的远端。
11.根据权利要求1所述的导管递送系统包装,其特征在于,所述端盖包括模制销。
12.根据权利要求11所述的导管递送系统包装,其特征在于,所述端盖是实心的。
13.根据权利要求11所述的导管递送系统包装,其特征在于,所述端盖中包括开口,所述导管递送系统包装还包括覆盖所述开口的过滤件。
14.根据权利要求1所述的导管递送系统包装,其特征在于,还包括位于由所述托盘和所述盖子限定的腔体内的装置移除辅助卡板。
15.一种导管递送系统组件,包括:
导管递送系统包装,所述导管递送系统包装包括由托盘、延伸管、端盖和盖子所限定的密封腔体;以及
位于所述密封腔体内的递送系统。
16.根据权利要求15所述的导管递送系统组件,其特征在于,还包括位于所述递送系统与所述托盘之间的所述密封腔体内的装置移除辅助卡板。
17.根据权利要求16所述的导管递送系统组件,其特征在于,所述托盘包括抓持特征部。
18.一种方法,包括:
在导管递送系统包装的密封腔体内提供递送系统;
将盖子从导管递送系统包装的托盘移除,以暴露所述递送系统的手柄;以及
将所述手柄从所述托盘移除。
19.根据权利要求18所述的方法,其特征在于,由第一使用者执行移除所述盖子,由第二使用者执行移除所述手柄。
20.根据权利要求18所述的方法,其特征在于,还包括:将所述递送系统从所述导管递送系统包装完全移除。
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US20180008799A1 (en) | 2018-01-11 |
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EP3481483A1 (en) | 2019-05-15 |
WO2018009477A1 (en) | 2018-01-11 |
US10485628B2 (en) | 2019-11-26 |
WO2018009479A1 (en) | 2018-01-11 |
CN109414564B (zh) | 2022-06-03 |
EP3481483B1 (en) | 2024-03-20 |
CN109414565B (zh) | 2021-07-20 |
US20180008366A1 (en) | 2018-01-11 |
EP3481482A1 (en) | 2019-05-15 |
WO2018009478A1 (en) | 2018-01-11 |
EP3481481A1 (en) | 2019-05-15 |
CN109414566B (zh) | 2022-03-22 |
WO2018009412A1 (en) | 2018-01-11 |
US10856951B2 (en) | 2020-12-08 |
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