CN104053456B - 双灭菌容器 - Google Patents
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Abstract
本公开是关于一种用于保持置换心脏瓣膜及相关的定位和安装装置的容器以及其使用方法,该容器构造成适合于在将用于置换心脏瓣膜的传送系统暴露于电离辐射的灭菌期间和之后容纳杀生物灭菌液。该容器包括限制该容器中的生物来源材料暴露于辐射的防护罩。该容器还提供用于置换心脏瓣膜的储存和运输容器,其中将生物来源材料维持在无菌流体环境中。
Description
技术领域
本公开是关于医疗器械和用于制造医疗器械的方法。更具体地,本公开是关于用于传送置换心脏瓣膜的医疗器械。
背景技术
种类广泛的体内医疗器械已被开发用于医疗用途,例如血管内用途。这些器械中的部分器械包含引导线、导管、医疗器械传送系统(例如,用于传送支架、移植物、置换瓣膜等)等。这些器械是利用多种不同制造方法中的任一方法而制造,并且可以根据多种方法中的任一方法而使用。就已知的医疗器械和方法而言,各自具有某些优点和缺点。对于替代的医疗器械以及用于制造和使用医疗器械的替代方法存在着持续的需求。
发明内容
本公开是关于一种用于生物来源医疗部件的可密封双灭菌容器,该可密封双灭菌容器包括:具有壁、近端、远端、和在这两端之间的内腔的空心元件,所述内腔构造成适合于容纳生物来源医疗部件和构造成适合于将生物来源医疗部件移植入生物体中的装置的至少一部分;远端盖;近端盖;和不透射线套管,其中近端盖具有次级近端盖和套圈,该圈套的尺寸被设计成适合于且能够可逆地将近端盖密封到通过该近端盖的传送导管,并且其中空心元件、远端盖、近端盖、次级近端盖、套圈、和传送导管的组合构成流体密封系统,该流体密封系统提供在空心元件内部和传送导管内腔之间的连续流体连接。
在另一个实施方式中,本公开涉及一种用于传送置换心脏瓣膜的密封系统;该系统包括:置换心脏瓣膜、传送导管、和构造成适合于定位并安装置换心脏瓣膜的元件;该系统还包括储存和运输容器,其中至少置换心脏瓣膜以及构造成适合于定位并安装置换心脏瓣膜的元件的一部分最初被容纳在流体填充的可拆除双灭菌容器内部。在储存和运输期间,在所提供的无菌系统环境内部,可将置换心脏瓣膜的生物来源部件维持在水合状态。
附图说明
图1示出了一种示例性置换心脏瓣膜传送系统及相关的封装件。
图2示出了可适用于本文中所公开双灭菌容器的置换心脏瓣膜及相关部件。
图3示出了本发明的双灭菌容器。
图4A和图4B示出了图3的双灭菌容器的局部分解视图。
图5示出了本发明的一个实施方式的空心元件的一个实施方式。
具体实施方式
应当参照附图来阅读下面的描述,其中在全部数个附图中类似的附图编号表示类似的元件。这些附图(不必标上刻度)并非意图限制请求保护的本发明的范围。详细描述和附图说明了请求保护的本发明的示范性实施方式。
本文中的所有数字均假设被词语“大约”所修饰。利用端点对数值范围的叙述包括纳入该范围内的所有数字(例如,1至5包括1.5、2、2.75、3、3.80、4、和5)。
除非上下文有明确规定,本说明书和所附权利要求中使用的单数形式“一”和“该”包括复数的所指对象。除非上下文中有明确规定,本说明书和所附权利要求中使用的术语“或”通常是指包括“和/或”的含义。
应注意的是,在本说明书中“一实施方式"、“一些实施方式”、“其它实施方式”等表示所描述的实施方式可包括特定的特征、结构、或特点,但每个实施方式可以不必包括该特定的特征、结构、或特点。此外,这种词组不必是指相同的实施方式。此外,当结合一个实施方式来描述特定的特征、结构、或特点时,除非明确地说明相反的情况,结合其它实施方式来采用这种特征、结构、或特点(无论是否明确地描述)落入本领域技术人员知识范围内。
图1示出了用于传送置换心脏瓣膜和与该瓣膜相关的封装件40的系统10。心脏瓣膜置换系统10可包括:置换心脏瓣膜12,具有生物来源部件16、和构造成适合于定位并安装置换心脏瓣膜12的相关部件14(图2)。这些部件可以是任何的本领域中已知的置换心脏瓣膜和相关部件,并且无需通过详细论述其细节来理解该系统的操作。非限制性的示例性置换心脏瓣膜12可以是包括一个或多个生物来源部件的瓣膜,并且可以是例如来源于经处理的人、牛、或猪的组织。用于传送置换心脏瓣膜的系统10也可包括附加部件,诸如控制手柄20、传送导管30和双灭菌容器50,该容器50构造成适合于容纳至少一种杀生物液(未图示),该容器50的杀生物液也可被容纳于传送导管30内部并且与其流体接触。杀生物液可含有例如戊二醛,戊二醛的功用是将该系统的接触表面灭菌并且任选地倾向于使置换心脏瓣膜的生物来源部件发生交联。
图3、图4A和图4B示出了构造成适合于容纳至少一种杀生物液的双灭菌容器50的各种部件。双灭菌容器50将被理解成包括一个容器,该容器构造成适合于容纳至少一种灭菌的杀生物液并且允许在不过度损害置换心脏瓣膜12的生物来源部件16的情况下对该容器的内容物和置换心脏瓣膜传送系统的其它部件进行电离辐射灭菌。
在一些实施方式中,这可以通过选择基本上不与接触的杀生物剂发生反应的结构材料、并且进一步通过包括不透射线套管90作为双灭菌容器50的一个部件而实现,不透射线套管90防止过量水平的被施加到用于传送置换心脏瓣膜的系统10的其余部件的电离辐射到达并损害生物来源部件。不透射线套管90可以是可拆除的,或者可以永久地附接到双灭菌容器50的一个或多个其它部件。在某些实施方式中,可将不透射线套管90容纳在灭菌容器50的,以确保外部不透射线套管90和灭菌容器50之间的空间保持无菌。在某些其它实施方式中,可将在外部不透射线套管90和灭菌容器50之间的连接加以密封,例如利用O形圈、垫片、密封胶等,以便将外部不透射线套管90与灭菌容器50之间的空间隔离并且在两者之间维持无菌环境。在其它实施方式中,外部不透射线套管90与灭菌容器50可一体形成以消除可能藏有污染的暴露界面。
当用于传送置换心脏瓣膜12的系统10的其它部件要求将该系统作为整体暴露于高水平的电离辐射以确保将杀生物的剂量水平传送到该系统的所有内部部件时,双灭菌容器50的使用是尤其需要的。此外,两种独立灭菌方法的使用(通过将双灭菌容器50包括在该系统内部而实现)被认为显著降低生物活性污染的风险。
图3、图4A和图4B示出了:空心元件80,该空心元件具有壁、近端、远端、和在这两端之间的内腔,所述内腔构造成适合于容纳生物来源医疗部件16及构造成适合于将生物来源医疗部件16定位并移植入生物体中装置14的至少一部分;远端盖60;近端盖70,其中近端盖70具有次级近端盖72和套圈74,该圈套74的尺寸被设计成适合于且能够可逆地将近端盖70密封到通过近端盖70的传送导管30。此外,空心元件80、远端盖60、近端盖70、次级近端盖72、套圈74、传送导管30、和手柄20的组合构成流体密封系统,该流体密封系统提供在空心元件80的内部和传送导管30的内腔之间的连续流体连接。在一些实施方式中,空心元件80和/或远端盖60可包括旋塞阀82,以便于在拆除双灭菌容器50之前用杀生物剂填充该系统和从该系统中排出杀生物剂。
在图5中更详细示出了包括空心主体的空心元件80,该空心主体具有足够的内部容积以便容纳置换心脏瓣膜和至少一部分的相关部件14,部件14构造成适合于定位并安装置换心脏瓣膜12。在一些实施方式中,置换心脏瓣膜12和构造成适合于定位并安装置换心脏瓣膜12的相关部件14以至少稍微扩张的形状态被容纳,该状态可以更充分地将它们的部件暴露于容纳在空心元件80中的杀生物液。尽管通常被图示为圆柱形,但应当理解的是必要时空心元件80可具有矩形截面或其它截面。空心元件80被描绘为具有整体结构,然而在一些实施方式中可将该空心主体制造在两个或更多的段中,这些段当连接时被适当地密封。例如,该空心主体可由沿可分离纵向接缝而连接的两个半圆柱形壁所构成,诸如蛤壳构造,在这两个壁之间有合适的垫片。在一些实施方式中,空心主体80可包括旋塞阀82。
如本文中所指出,基本上不与接触的杀生物剂发生反应的结构材料(诸如聚碳酸酯)可用于空心元件80和双灭菌容器50的其它部件。可将这种材料选择成对可见光是部分或完全透明,由此允许对内容物进行目视检查。另外,无论是空的或者填充有杀生物液,当以30、40、50戈瑞的水平(或者在一些实施方式中,以更多的水平)吸收电离辐射时这些材料应当基本上保持化学性质和机械性质不变。在某些实施方式中,空心元件80、远端盖60、和近端盖70中的至少一个的内部的至少一部分可包括与空心元件的内部流体连通的抛光表面,该抛光表面被认为有助于从双灭菌容器50内部的杀生物液中除去气泡。另外,空心元件80可包括一个或多个特征,该特征构造成适合于引导当填充有流体并发生方位变化时存在于双灭菌容器50内部的任何气泡的运动。这种特征可包括脊部、凹槽、和/或锥形物。
如图所示,可利用配对的螺纹段将远端盖60和近端盖70固定到空心元件80。也可采用其它方式的可逆附接。尽管图示的实施方式描绘了在空心主体80上的外螺纹84,86和在端盖60,70上的对应的内螺纹,但应当理解的是在双灭菌容器50的一端和两端,端盖可具有外螺纹且空心主体可具有内螺纹。
近端盖70可包括次级近端盖72,该次级近端盖连同套圈74起到将双灭菌容器50密封到由附图编号30所标示的系统10其它部件的作用,以便在传送置换心脏瓣膜12同时维持与其内腔的流体连接。
可拆除的不透射线套管90通常将具有与空心元件80的外部形状和尺寸基本上匹配的内腔。不透射线套管90可包括不透射线的固体或者不透射线的流体或凝胶。在一部分的灭菌步骤期间,可以任选地将不透射线套管90固定到空心元件80,例如利用紧定螺钉92。在替代方式中,不透射线套管可由若干片块构成,并且用夹紧元件(未图示)将其固定。在这种实施方式中,这些片块可包括沿着连接部的重叠区,用以确保高于期望水平的电离辐射不会达到生物来源部件16。在其它实施方式中,不透射线的套管90可永久地附接到双灭菌容器50的一个或多个其它部件。可将组合的不透射线套管90的不透射线性选择成使得连同空心主体80,无论双灭菌容器50是空的或者用杀生物液填充,当双灭菌容器50吸收30、40、50戈瑞(或者在一些实施方式中吸收更多)时生物来源医疗部件16吸收不大于4戈瑞。
尽管远端盖60和近端盖70中的一个或两个的尺寸可被设计成且构造成将不透射线套管90固定在空心元件80周围的位置,但应当理解的是在一些实施方式中不透射线套管90可构造成在不拆除一个或两个端盖的情况下从空心元件80中拆除。在这种实施方式中,可采用定位螺钉94或者其它固位装置。
用于双灭菌容器50的一个可行的非限制性的使用顺序可描述如下。置换心脏瓣膜12和构造成适合于定位并安装置换心脏瓣膜12的相关部件14可收缩到传送导管30内部,因此可将组装的双灭菌容器50定位成部分地包住传送导管30的远端。一旦利用次级近端盖72和套圈74将近端盖70固定到传送导管30的远端,则可使置换心脏瓣膜12和构造成适合于定位并安装置换心脏瓣膜12的相关部件14从传送导管30的远端行进,直到它实现扩张状态,例如图2的形状。然后可用杀生物液(诸如戊二醛醇溶液)填充连续的内腔连接手柄20、传送导管30、和双灭菌容器50,并加以冲洗以除去气泡和任何偶然被导入的碎屑。在冲洗之后,可将旋塞阀82和与手柄20相连的相应旋塞阀关闭,以便将该系统密封并且将杀生物液容纳在现在密闭的系统内部。
可将该密闭系统置于封装件40中并暴露于具有充分穿透能力的电离辐射源达充分的时间以便将封装件40的内容物灭菌。不透射线套管90的功用是限制生物来源部件16吸收的辐射。在一些实施方式中,当该系统作为整体已吸收30、40、50戈瑞(或者在一些实施方式中吸收更多)时,被生物来源部件16吸收的辐射将小于4戈瑞。在此时,应当理解的是已利用两种独立的方法将该系统的内容物灭菌并且随时可用于在心脏瓣膜置换术之前的储存和配送。双灭菌容器50构造成适合于在使用前将生物来源医疗部件保持在水合状态和无菌环境。
尽管本文中所描述的说明性例涉及置换心脏瓣膜,但也涵盖具有其它生物来源医疗部件的双灭菌容器的使用。在这种实施方式中,生物来源医疗部件可以不同的瓣膜结构、支架、移植物等形式而存在。用于这种用途的双灭菌容器会要求在尺寸、形状和/或材料方面作出修改。
在不背离本发明的范围和原理的前提下,本发明的各种修改和变更对于本领域技术人员将变得显而易见,并且应当理解的是本发明并不过分地局限于在上文中所陈述的说明性实施方式。所有的公开和专利以参考的方式并入本文中,仿佛各单独的公开和或专利特别地且单独地表示以参考的方式并入本文中。
Claims (32)
1.一种用于生物来源医疗部件的双灭菌容器,包括:
空心元件,所述空心元件具有壁、近端、远端、和在这两端之间的内腔,所述内腔构造成适合于容纳生物来源医疗部件以及一装置的至少一部分,该装置构造成适合于将所述生物来源医疗部件移植入生物体中;
远端盖;
近端盖;和
不透射线套管,
其中所述近端盖具有次级近端盖和套圈,所述套圈的尺寸被设计成适合于且能够可逆地将所述近端盖密封到穿过所述近端盖的传送导管,
并且其中所述空心元件、所述远端盖、所述近端盖、所述次级近端盖、所述套圈、和所述传送导管的组合构成流体密封系统,所述流体密封系统提供在所述空心元件的内部和所述传送导管的内腔之间的连续流体连接。
2.根据权利要求1所述的双灭菌容器,其中所述空心元件、所述远端盖、和所述近端盖包含基本上不与至少一种杀生物剂反应的材料。
3.根据权利要求1所述的双灭菌容器,其中所述空心元件、所述远端盖、和所述近端盖包含当吸收至少4戈瑞的电离辐射时基本上不发生化学变化和机械变化的材料。
4.根据权利要求1至3中任一项所述的双灭菌容器,其中所述空心元件、所述远端盖、和所述近端盖包含当吸收至少30戈瑞的电离辐射时基本上不发生化学变化和机械变化的材料。
5.根据权利要求1至3中任一项所述的双灭菌容器,其中所述空心元件、所述远端盖、和所述近端盖包含当吸收至少40戈瑞的电离辐射时基本上不发生化学变化和机械变化的材料。
6.根据权利要求1至3中任一项所述的双灭菌容器,其中所述空心元件、所述远端盖、和所述近端盖包含当吸收至少50戈瑞的电离辐射时基本上不发生化学变化和机械变化的材料。
7.根据权利要求1所述的双灭菌容器,其中所述空心元件、所述远端盖、和所述近端盖包含当填充有根据权利要求2所述的杀生物剂时在吸收至少4戈瑞的电离辐射时基本上不发生化学变化和机械变化的材料。
8.根据权利要求1所述的双灭菌容器,其中所述空心元件、所述远端盖、和所述近端盖包含当填充有根据权利要求2所述的杀生物剂时在吸收至少30戈瑞的电离辐射时基本上不发生化学变化和机械变化的材料。
9.根据权利要求1所述的双灭菌容器,其中所述空心元件、所述远端盖、和所述近端盖包含当填充有根据权利要求2所述的杀生物剂时在吸收至少40戈瑞的电离辐射时基本上不发生化学变化和机械变化的材料。
10.根据权利要求1所述的双灭菌容器,其中所述空心元件、所述远端盖、和所述近端盖包含当填充有根据权利要求2所述的杀生物剂时在吸收至少50戈瑞的电离辐射时基本上不发生化学变化和机械变化的材料。
11.根据利要求8至10任一项所述的双灭菌容器,其中当所述空心元件吸收30戈瑞的电离辐射时所述生物来源医疗部件接受至少4戈瑞的电离辐射。
12.根据权利要求8至10中任一项所述的双灭菌容器,其中当所述空心元件吸收40戈瑞的电离辐射时所述生物来源医疗部件接受至少4戈瑞的电离辐射。
13.根据权利要求8至10中任一项所述的双灭菌容器,其中当所述空心元件吸收50戈瑞的电离辐射时所述生物来源医疗部件接受至少4戈瑞的电离辐射。
14.根据权利要求11所述的双灭菌容器,其中所述生物来源医疗部件是经处理的牛组织。
15.根据权利要求14所述的双灭菌容器,其中所述生物来源医疗部件是置换瓣膜。
16.根据权利要求15所述的双灭菌容器,其中所述置换瓣膜是置换心脏瓣膜。
17.根据权利要求11所述的双灭菌容器,其中所述生物来源医疗部件是经处理的猪组织。
18.根据权利要求17所述的双灭菌容器,其中所述生物来源医疗部件是置换瓣膜。
19.根据权利要求18所述的双灭菌容器,其中所述置换瓣膜是置换心脏瓣膜。
20.根据权利要求1至3中任一项所述的双灭菌容器,其中所述空心元件、所述远端盖、和所述近端盖中至少一个的至少一部分包括对可见光为透明的区域。
21.根据权利要求1至3中任一项所述的双灭菌容器,其中所述空心元件、所述远端盖、和所述近端盖中的至少一个的至少一部分包括与所述空心元件的内部流体连通的抛光表面。
22.根据权利要求1至3中任一项所述的双灭菌容器,其中所述远端盖和所述近端盖中的至少一个的至少一部分包括与所述空心元件的内部流体连通的锥形面。
23.根据权利要求1至3中任一项所述的双灭菌容器,其中所述远端盖和所述近端盖中的一个包括右旋内螺纹部,所述远端盖和所述近端盖中的另一个包括左旋内螺纹部并且所述空心元件包括在第一端的右旋外螺纹和在第二端的左旋外螺纹。
24.根据权利要求1至3中任一项所述的双灭菌容器,其中所述远端盖和所述近端盖中的一个包括右旋外螺纹部,所述远端盖和所述近端盖中的另一个包括左旋外螺纹部并且所述空心元件包括在第一端的右旋内螺纹和在第二端的左旋内螺纹。
25.根据权利要求1至3中任一项所述的双灭菌容器,其中所述远端盖包括右旋内螺纹部,所述近端盖包括左旋外螺纹部并且所述空心元件包括在第一端的右旋外螺纹和在第二端的左旋内螺纹。
26.根据权利要求1至3中任一项所述的双灭菌容器,其中所述近端盖包括右旋内螺纹部,所述远端盖包括左旋外螺纹部并且所述空心元件包括在第一端的右旋外螺纹和在第二端的左旋内螺纹。
27.根据权利要求1至3中任一项所述的双灭菌容器,其中所述不透射线套管是可拆卸的。
28.根据权利要求27所述的双灭菌容器,其中可在不从所述空心元件中拆除所述近端盖或所述远端盖的情况下拆除所述不透射线防护罩。
29.根据权利要求1至3中任一项所述的双灭菌容器,其中所述空心元件、所述近端盖、和所述远端盖由聚碳酸酯制成。
30.根据权利要求1至3中任一项所述的双灭菌容器,其中所述空心元件包括利用可分离纵向接缝而连接的第一部件和第二部件。
31.根据权利要求1至3中任一项所述的双灭菌容器,其中所述空心元件包括一个或多个构造成适合于引导当所述空心元件填充有流体并经历方位变化时会存在于腔室内的任何气泡的运动。
32.一种用于传送置换心脏瓣膜的系统,包括:
置换心脏瓣膜;
传送导管;和
元件,所述元件构造成适合于定位并安装所述置换心脏瓣膜;
所述系统还包括储存和运输容器,其中至少所述置换心脏瓣膜以及构造成适合于定位并安装所述置换心脏瓣膜的所述元件的一部分最初被容纳在流体填充的可拆除的根据权利要求1-31中任一项所述的双灭菌容器的内部。
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US201161559914P | 2011-11-15 | 2011-11-15 | |
US61/559,914 | 2011-11-15 | ||
US13/676,695 US8851286B2 (en) | 2011-11-15 | 2012-11-14 | Dual sterilization containment vessel |
US13/676,695 | 2012-11-14 | ||
PCT/US2012/065250 WO2013074771A1 (en) | 2011-11-15 | 2012-11-15 | Dual sterilization containment vessel |
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CN104053456A CN104053456A (zh) | 2014-09-17 |
CN104053456B true CN104053456B (zh) | 2016-12-28 |
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EP (1) | EP2780042B1 (zh) |
JP (1) | JP2015505683A (zh) |
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CA (1) | CA2856072C (zh) |
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-
2012
- 2012-11-14 US US13/676,695 patent/US8851286B2/en active Active
- 2012-11-15 CA CA2856072A patent/CA2856072C/en not_active Expired - Fee Related
- 2012-11-15 CN CN201280067156.0A patent/CN104053456B/zh not_active Expired - Fee Related
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JP2015505683A (ja) | 2015-02-26 |
WO2013074771A1 (en) | 2013-05-23 |
EP2780042B1 (en) | 2016-03-09 |
US20130118949A1 (en) | 2013-05-16 |
US10849744B2 (en) | 2020-12-01 |
US20170281329A1 (en) | 2017-10-05 |
US20150005873A1 (en) | 2015-01-01 |
EP2780042A1 (en) | 2014-09-24 |
CA2856072C (en) | 2020-05-12 |
CA2856072A1 (en) | 2013-05-23 |
US9707077B2 (en) | 2017-07-18 |
CN104053456A (zh) | 2014-09-17 |
US8851286B2 (en) | 2014-10-07 |
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