CN1897982A - 确定消毒处理有效性的方法及设备 - Google Patents
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Abstract
一种设备、系统及方法,用于检验在低能电子束消毒室内被操控的若干部件获得了所期望的消毒保证水平(SAL)。这些部件优选地被预先消毒,且以组件的方式连接在一起,借助于使这些部件受到低能(小于300KeV)的电子束的辐射,建立并保持了连接无菌。借助于测量传递到传感器(也被称为剂量计)的消毒剂量,完成检验,该传感器被安置在消毒处理中,用以模仿这些部件。
Description
发明领域
本发明总的涉及预先消毒部件的自动检查、分离(staging)以及组装的领域,尤其涉及医疗部件的领域,借助于低能电子束场来保持无菌。
背景技术
一般的,医疗产品的消毒取决于杀死病原微生物的处理的能力。用以消毒医疗产品的辐射的应用在整个世界内被广泛地使用,并被认为是一种安全有效的消毒方式。第一次商业上对医疗器件应用电子束消毒处理是由Johnson & Johnson的分公司Ethicon公司在1956年研制出来的。在二十世纪六十年代早期,在英国研制出了使用来自于钴-60的伽马射线用于消毒一次性医疗器件。由于早期电子束系统的较差的可靠性,因而医疗产品的辐射消毒被钴-60(伽马)辐照器支配,钴-60辐照器没有类似的可靠性的问题。
随着专门从事高能物理研究的美国国家实验室的出现,主要的努力是提高关键加速器部件的可靠性和性能。到了二十世纪七十年代,涉及研制射线照像和肿瘤学的产业进一步提高了电子加速器的耐用性和可靠性。部件性能的提高以及计算机化控制的集成鼓励了重新评价该技术的商业化可能性。这以后不久,对基于消毒的高能(>300KeV)的电子束的兴趣迅速地发展起来。
或许,辐射最大的产业应用是修饰聚合物。辐射被用来使单体聚合并固化成聚合物、使聚合物交联、以及将不同类型的聚合物移植到聚合物分子上,用以形成具有特定性能的新材料。辐射还被用于意图的聚合物降解、以及将分子量分布修整以服务特定的产业和商业性目的。辐射的这种产业应用被低能(<300KeV)电子束系统支配。
1999年,在美国专利申请No.09/294,964中描述了在医疗器件的消毒中使用低能(<300KeV)电子束系统,该申请提交于1999年4月20日,现在是美国专利No.6,__,该专利已转让给本申请的受让人——Baxter国际公司,相关的公开内容在此作为参考引入。电子束消毒单元的尺寸和成本是使步伐朝低能消毒系统迈进的两个较大的因素。消毒辐射穿透的深度变为折衷的深度。高能系统可以实现超过一米的穿透深度,而低能射束的穿透深度被限制在低至仅有几个微米。
作为处理所关心的,用于医疗器件消毒的低能电子束的明显减小的辐射穿透深度导致了确定消毒有效的问题。美国FDA要求“所有用来生产医疗器件的处理都要确定有效”(21C.F.R.§820.752),包括电子束消毒。这种确定有效的目的是确定可用来满足所期望消毒保证水平以及允许“剂量测定释放”的最小曝光剂量,它基于物理放射处理数据而不是实际的消毒试验产品消毒。
因此,确定有效必须从选择消毒保证水平开始,测量一批中的一个单元在暴露于特定消毒剂后仍然未被消毒的概率。例如,10-3的SAL意味着在一千中有一个器件可能会未被消毒。在确定辐射消毒有效的剂量设定阶段中选择适当的SAL。在很多情况下,器件所意图的用途将会规定对具体SAL的需要。对于扩散性医疗器件的通常接受的SAL为10-6。然而,对于“消毒”的声明,一些欧洲国家只认可10-6的SAL。在这样的情况下,所意图使用的国家将会规定SAL高至器件所意图的用途。
尽管伽马射线和乙撑氧气体消毒都是被确认的有效而且容易可行的技术,但是对电子束的增加的关注可以归于在任何目前认可的消毒方法中它具有的最短的处理周期。在高能和低能电子束处理中,扫描产品若干秒钟的时间,而且大部分处理时间都花费在将产品运送进出屏蔽室上。在使用建立并认可的剂量测定释放方法下,高能电子束消毒下的产品可以在消毒30分钟内解除隔离。然而,现有技术并未足够研制出一种用于确定消毒有效和常规监测低能电子束消毒的方法。
研制出本发明,作为这一问题的解决方案,本发明提供了一种用于在低能电子束消毒系统的确定有效中使用的设备。而且,本发明提供了一种费效比较高且可靠地提供常规剂量测定监测用于低能电子束消毒系统的消毒处理的方法。
发明内容
总的来说,本发明包括一种用于检验在低能电子束消毒系统中传递的辐射剂量以实现部件消毒的方法和设备,诸如消毒医疗器件。
具体而言,作为本发明的一个实施例,公开了一种单个部位剂量计组件。该组件包括第一部件座,其具有适合于将剂量计定位在其中的空腔;和同轴构造的通道,用以允许辐射进入空腔部分。第二部件座固定在该第一部件座上,并且包括内表面,该内表面具有构造成抵靠空腔内表面的突出,用以将剂量计保持在其中。组件还可以包括用以将第一剂量计座固定在第二剂量计座上的机构,并将所产生的组件固定在辐射消毒部位上。
还描述了一种用于检验消毒位于低能电子束消毒系统中的若干部件的方法。这种新方法包括以下步骤:将在低能电子束消毒系统内待消毒的部件放在部件托盘上;确定施加给该部件时产生所期望的消毒保证水平(SAL)的最小消毒剂量;将指示器联到该消毒系统内,作为用来指示完成至少最小消毒剂量的部位;建立上述部件处的消毒剂量和该指示器处的剂量之间的相互关系;使该部件和指示器暴露在一消毒源下;确定指示器处的剂量;以及根据在相关的指示器处确定的剂量,确定在上述部件处所得到的消毒剂量的效力。
在所公开方法的一个实施例中,建立相互关系的所述步骤包括以下步骤:将所指定的部位暴露在一消毒源下,以模仿消毒系统的工作;测量在每个指示器处所接受到的剂量;以及重复上述暴露步骤和测量步骤,以确定消毒部位所测得的消毒剂量水平与指示部位所测得的消毒剂量水平之间的关系。
还公开了一种能够检验待连接在一起的两个部件的消毒的组件。该组件包括第一部件托架和第二部件托架。每个托架优选地包括需要阈值消毒剂量以实现部件消毒的部件部位;和定位在该部件部位附近且具有剂量计的剂量计部位,用以接收对应于部件部位所接受到的消毒剂量水平的施加剂量。
重要的是注意在指示器部位最终所获得的剂量并不必需要等于在消毒部位所获得的剂量,也不是必需要在指示器部位的剂量等于消毒剂量。
在所述组件的一个实施例中,第一部件托架还包括用以控制剂量计在剂量计部位所接受到的消毒剂量的机构。一个实施例中的该机构包括具有直径和深度的通道,且该通道被定位在剂量计部位上方。通道的直径和深度可以具有任何合适的尺寸,以允许适当量的辐照。
组装好的剂量计部位优选地包括:第一保持器座,其具有:在该保持器座的壁内限定出的容器,用以将剂量计装入其中;和通道,该通道具有深度和直径,其穿过该容器的周围内的壁;以及第二保持器座,其构造有配合部分,该配合部分被装配在第一保持器座的容器内,以致抵靠其中的剂量计。
第一部件托架可以包括数量从1到10的部件部位和数量从1到15的剂量计部位。
在本发明中提供了这些以及其它的特征。在下面详细的论述中将给出若干部件、它们的目的以及可能的替代性实施例的更详细的描述。
附图说明
当结合附图考虑以下描述时,可以更容易理解本发明的细节,其中:
图1是袋消毒托盘背面的透视图,其具有联接在其上面的本发明的剂量计保持器的一个实施例;
图2是显示联接在图1所示的袋消毒托盘上的本发明的实施例的后视图;
图3是显示联接在图1所示的袋消毒托盘上的多部位剂量计保持器的俯视图;
图4是联接在图1所示的袋消毒托盘上的剂量计保持器的侧视图,包括所显示的医疗溶液袋和小瓶/器械;
图5是本发明的多部位剂量计保持器的一个实施例的分解图;
图6是显示在图5中的剂量计保持器的组装实施例的截面图;
图7是图6中所显示的实施例的第二座或者上座的平面图;
图8是图6中所显示的实施例的第一座或者下座的平面图;
图9是小瓶/器械托盘的一个实施例的透视图,其具有联接在其上面的本发明的多部位剂量计保持器的另一个实施例;
图10是显示联接在图9所示的小瓶/器械件托盘上的多部位剂量计保持器的一个实施例的侧视图,包括显示连接的器械和药瓶;
图11是显示联接在图9所示的小瓶/器械托盘上的多部位剂量计保持器的一个实施例的正视图;
图12是显示联接在图9所示的小瓶/器械托盘上的多部位剂量计保持器的一个实施例的俯视平面图;
图13是单个部位剂量计保持器的第二座或者下座的一个实施例的透视图;
图14是单个部位剂量计保持器的第一座或者上座的一个实施例的透视图;
图15是用于在图9所示的小瓶/器械托盘的器械一侧上使用的多部位剂量计保持器的另一实施例的分解图;
图16是用于联接在图9所示的小瓶/器械托盘上的多部位剂量计保持器的截面图;
图17是本发明的多部位剂量计保持器的第二座或者上座的一个实施例的俯视图;
图18是本发明的多部位剂量计保持器的第一座或者下座的一个实施例的俯视图;
图19(a)和19(b)是图13和14中显示的组装的单个部位剂量计保持器的透视图(分别是上图和下图);
图20A-C是示出室门开口的次序以使托盘移动通过消毒处理的消毒间的示意图;
图21和22是袋消毒室的若干内部部件的剖面图;以及
图23是小瓶/器械消毒间的剖面侧视图。
具体实施方式
尽管本发明能具有多种不同形式的实施例,但是本公开内容将详细描述本发明的至少一个优选实施例以及若干可能的替代实施例,且要理解本公开内容仅作为本发明原理的示例,而并不意图将本发明广义的方面限定在所示出的具体实施例。
本发明提供了一种用于检验低能电子束消毒的组件以及一种使用该组件的方法。出于本发明的目的,使用了以下定义的术语:
消毒(杀菌、灭菌等):在使用物理的或者化学的方法破坏微生物生命后所获得的使用或者条件的行为,其中微生物包括病原,诸如高抗菌的内孢子和病毒;
消毒保证水平(SAL):一种表明在暴露于特定消毒剂后,一批内的一个单元仍然未被消毒的概率的测量指标;
低能电子束:工作在小于300KeV、优选地在从约60KeV到约150KeV的范围内的能量下的电子束或者电子束阵列,;
确定消毒有效:确定暴露于特定剂量或水平的辐射下将产生所期望的消毒保证水平(SAL)的处理;
检验消毒:确定所期望部件暴露在适量辐射下以实现消毒的处理;
剂量计:当被照射时在某些性能上表现出可以计量的变化的任何装置,通过使用合适的分析仪器和技术,上述性能能够与给定材料中所吸收的剂量关联起来;
部件:任何能够消毒的医疗器械,诸如药瓶、注射器、重构器件、医用管、IV袋、插管等;以及
托盘(或托架):在消毒处理中,尤其是在消毒连接处理中,被构造用于容纳、运送以及在一些情形下屏蔽部件的装置。
现有技术公开了用于检验紫外线消毒(McGeorge等人的美国专利No.6,475,433)和热消毒(Gillis的美国专利No.6,340,590)的方法和设备。然而,如下面说明书将阐述的那样,检验低能电子束系统中的消毒对本领域技术人员提出了非常不同的挑战。
因此,本发明包括了用于自动检验部件消毒的方法和设备,尤其是在消毒区域内的连接起来的两个或者多个部件。虽然部件可以由任何已知材料制成,但是物体优选地由能够容易消毒的材料制成。例如,玻璃小瓶/器械可以以消毒的方式连接在刚性塑料重构装置上,形成小瓶/器械组件(VDA)。然后,该组件可以消毒连接在流体袋的柔性管部分上,形成最终的组件。这样的小瓶/器械组件(VDA)和最终的组件显示在图中,并且在此描述。然而,本发明并不应当限于这些实施例,这些实施例仅包括用于示例目的。
在被预先消毒后,部件被容纳到采用本发明的消毒托盘中,以便于检验。在部件移动进入消毒系统内时,消毒托盘用于容纳、运送以及在一些情形下屏蔽部件的若干部分。这些托盘可以专门设计用于容纳单个尺寸的部件,诸如重构装置,或者可以调节用于变化尺寸的部件,诸如药瓶。总的参照图1-18,可以看到一些消毒托盘的例子。
图1-4示出了袋托盘70a。图9-12示出了小瓶和器械托盘70b。袋托盘70a优选地是金属结构,其用于保持至少一个袋部件到位,以便于在部件的至少一部分被保持在电子束场内时连接在至少一个其它部件上。同样的,小瓶和器械托盘70b优选地是大致金属结构,其也用于使部件定位,以便于在被保持在电子束场内时连接。在两种托盘的情形中,都还有屏蔽部件的若干部分在连接中不受电子束场辐射的作用。如本领域技术人员所理解的那样,托盘的物理形式取决于许多因素,包括:例如所连接的部件的尺寸、连接策略等。在美国待审专利申请No.10/__(代理人卷宗号DDR-5392-A2(1417B P854)中更完全地给出了这些托盘器械的进一步描述,该申请提交于2003年12月23日,并且转让给本发明的受让人——Baxter国际公司,其相关的公开内容在此作为参考引入。
在本发明中,袋托盘70a一般被设计成借助于夹具75而握住并保持多至四袋医疗溶液的管子(SB)和四个小瓶/器械组件(VDA)(见图4),如图1所示。在此位置上,每袋医疗溶液的管子的开口端都会与其中一个小瓶/器械组件(VDA)的端部对准。虽然这些部件被预先消毒,但是期望以保持消毒的方式建立管端和小瓶/器械之间的连接。参照图3和4,托盘70a上、部件停留的位置被叫做部件部位73。具体而言,部件端(待连接的部件的部分)的位置确定了该部件部位73。在本实施例中,两个部件所要连接在一起的端部被保持彼此如此接近,以致对于每对部件仅存在一单个部件部位73。然而,替代性的构造是可以的。
大致参照图9-12所示的小瓶和器械托盘,显示了四个托架77,它们被构造成支承重构装置(RD),同时小瓶保持器71显示被构造成装有四个倒置的药瓶。类似期望在这些部件之间建立消毒连接,从而做出四个完整的小瓶/器械组件(VDA),用于以后在连接消毒医疗溶液袋中使用。另外的托盘设计可以考虑支承其它用于消毒的医疗部件。
参照图1-4,每个托盘都被设计成使所保持的部件暴露在低能电子束场所建立的作用消毒区域下。袋托盘70a允许消毒电子束穿过窗口41。一般的,如在本发明中,使用多于单个电子束管来解决遮蔽时,或者电子束辐照可能会尤其使具体的部件或者部件内容受到降低时,可以在消毒间内设置另外的单独屏蔽(未示出),用于例如袋(SB)和小瓶/器械组件(VDA)暴露的部分。理想的是,只有部件的连接端(即位于部件部位73内的部分)被暴露在电子束场下。部件的其余部分优选地被消毒间内的托盘或者替代性装置屏蔽。
在本实施例中,在部件部位73暴露在电子束场下时,通过使部件至少其中之一朝着另一部件致动而使它们连接在一起。部件的运动应当被限制在电子束场的约束下,直到完成正确连接为止。
本发明的关键方面是开始确定暴露的部件在特定剂量水平下消毒有效的能力。本发明的另一特征是提供常规消毒处理的剂量监测。
使用常规辐射监测装置,诸如剂量计用于处理已经使用了多年,并且在产业上被广泛地认可和理解。然而,所有使用的常规监测剂量计的夹具和处理都是基于辐射源穿过剂量计、其包装以及在许多情形下夹具的假定。该假定基于这样的事实,这种辐射消毒应用包括使用穿透放射性同位素或者高能电子。由于这种物质的深穿透能力,因而剂量计的精确位置并不重要,而且辐射源也不直接暴露给剂量计。
然而,本发明的这个实施例采用了“非穿透性”(相对感觉)的低能电子。设计了监测夹具,用以在低能处理中工作,此时需要直接暴露剂量计。在本发明的一个优选实施例中,剂量计为放射性铬膜。除了使放射性铬膜直接暴露给电子束外,监测夹具被放置成使得剂量计膜所受到的剂量将近似与产品接受到的剂量相关。剂量计的位置被称为指示器部位。
在附图中显示了三个不同的消毒确定消毒有效和常规监测剂量计夹具。图13和14示出了基本的单个部位剂量计保持器10的几个不同的半个,而在图19(a)和19(b)中显示了组装好的夹具。图5-8示出了多部位剂量计保持器40(a),用于联接图1-4所示的袋托盘70a。图15-18示出了多部位剂量计保持器40(b),用于联接图9-12所示的小瓶和器械托盘70b。总的来说,所显示的各自的剂量计保持器或者夹具每个都包括构造成连接在托盘——袋托盘或者小瓶/器械托盘上的基本板。该基本板可以是单个金属板,或者设计成由任意数量的可连接零件组成。对于具体的保持器,它可以容纳少到单个的剂量计,诸如剂量计膜,或者多个这样的器械。
参照图13、14和19,显示了单个部位剂量计保持器10的半个。保持器10(组装好时)包括第一剂量计座12(图14)和第二剂量计座(图13)。第一座12包括内表面16,该内表面16具有在其中限定出的大致方形的空腔18;和外表面20,其具有从其中穿过、通向空腔18的圆柱形通道22。该空腔18可以具有任何期望的形状,以容纳放射性铬膜,该放射性铬膜一般为一小方形片,但是其它形状和尺寸可能会更适合于替代性实施例。图14所示的实施例还示出了从空腔18伸出的四个径向边角的凹口24。这些凹口24有利于从空腔18上取下放射性铬膜。如果想要的话,则通道22还可以加工成多种形状。在替代性实施例中,通道22可以位于第二剂量计座14中,或者穿过剂量计座的相邻侧。
在本实施例中,图13所示的第二剂量计座14包括内表面26,该内表面26具有构造成抵靠第一座12的空腔18的突出28。在使用中,在第一座12的空腔18内定位有放射性铬膜剂量计30,其借助于第二座14的突出28而被保持到位。
使用第一机构(未示出),诸如销、螺栓或者类似的装置,穿过孔79,将第一座12固定在第二座14上,从而形成剂量计保持器或者组件10(图19)。另外,可以使用第二机构来将保持器10固定在辐射消毒部位上,诸如部件托盘上。对于某些应用,第一机构可以执行第二机构的工作。
用于制造剂量计保持器10的材料必须是防辐射材料,且必须具有足够的密度和厚度,以便于保护所装的剂量计30免于间接暴露在电子束下。剂量计30过多暴露是所要关心的,因为它将不利地影响确定消毒有效和常规监测。
作为控制剂量计30暴露的装置,通道22直径和深度的尺寸可以调节。通道22的直径越大,深度越小(即阻挡材料的厚度),剂量计30将接受到的剂量越大。相反,通道22的直径越小,深度越大,剂量计30所接受到的剂量越小。在优选实施例中,通道深度被加工到0.124英寸(3.15毫米),而直径为0.234英寸(5.94毫米)。通道深度优选地落在从约0.070到约0.175英寸(1.78-4.45毫米)之间的范围内,而优选的直径在从约0.175到约0.290英寸(4.45-7.37毫米)的范围内。然而,随着组件10的应用和定位变化,以及剂量计厚度和表面面积变化,存在无穷多组合的可以利用的通道22直径和深度,而不会背离本发明所意图的目的。
现在参照图5-8,可以更容易地看到和理解袋托盘用的多部位剂量计保持器40a的实施例。与单个部位组件类似,多部位保持器包括第一座46和第二座48。所示出的实施例设计有四个剂量计部位50,它们沿保持器40a的长度等距间隔开。剂量计部位50的数量可以随着在部件托盘70中提供的部件部位73的数量变化,但是正好一对一的关系并不是必需的。每个部件部位73较大数量的剂量计部位50可以提高(或者必需用于)确定消毒有效和常规监测。
在本实施例中,多部位保持器40a的第一座46在其它方式上不同于单个部位保持器10的第一座。存在装有放射性铬膜剂量计30的空腔18,但是在第一座46中没有通向空腔的通道。而是,第二座48在包括突出28以配合在第一座46的空腔18内时,具有穿过突出28的通道22。通道直径和深度尺寸的作用及范围可以另外与单个部位剂量计保持器10中的通道的相等。当然,替代性实施例可以包括位于第一座46上的通道22,该第一座46仅需要将保持器40a不同定位在托盘70a上。
如图6的截面图所示,第一座和第二座46和48被固定在一起,从而形成了多部位保持器40a。然后,保持器40a被固定在袋托盘70a上,如图1-4所示。在本实施例中,保持器40a被固定在托盘70a的背面72上。如下文更详细解释的,保持器40a的每个剂量计部位50都被定位与托盘70a的前面74上的部件部位73相对应。此外,可以用一个以上的剂量计部位对应单个部件部位,或者反过来。类似的,可以在每个托盘70a上采用一个以上的保持器40a,例如,一个在前面,而一个在托盘的后面,或者托盘上的第一部件一个,且第二部件一个。
参照图15-18,示出了多部位剂量计保持器的另一个实施例,保持器40b。保持器40b具有5∶4的剂量计部位50和部件部位73数量之比。尽管保持器40b形成得明显不同于图5-8所示的袋托盘的剂量计保持器40a,但是两个实施例之间的剂量计部位50实际上是相同构造的。公开用于保持器40a的替代性实施例也可以用于保持器40b。
图9-12示出了保持器40b与小瓶/器械托盘70b的联接,在将剂量计部位50放在部件部位73附近的位置上。每个部件部位73都被夹在两个剂量计部位50之间,以便于提高确定消毒有效。
已经讨论了本发明的物理细节的实施例,下面详细描述确定处理和消毒系统,其中可以使用参照的保持器以及优选的操作参数。
在确定处理的第一步中之一是确定需要达到期望SAL时给产品的消毒剂量。两种方法之一是采取选择消毒剂量:利用生物泡信息或者增加剂量所得到的信息选择消毒剂量;或者利用25kGy的消毒剂量,跟着证明剂量的合适度。一旦建立了,可以以若干本领域技术人员所知的方式实现最小的辐射剂量,包括增加电子束的强度(电流)或者增加产品处于电子束场的时间。
下一步是确定待消毒产品的剂量分布。进行剂量分布研究或者剂量图谱,以确认处理的产品内最小和最大剂量的区域,并且进行重现该处理。然后将此信息用来选择进行处理的常规监测位置。也就是说,必须确定常规监测剂量计的位置,从而在消毒中,剂量计所吸收的辐射水平(容易测量)与待消毒的部件的辐射水平(不容易测量)相称。
在低能电子束下,难以得到产品所接受的剂量和剂量计所接受的剂量之间的关系,因为产品几何形状的复杂度以及剂量计沿电子场的直接路径被充满的趋势。在本发明下,可以得出所测得的剂量计的辐照和产品所期望的辐射之间的关系。
参照图20-22,用于消毒连接多个部件的系统的实施例包括消毒室112,其具有低能电子束源102;和部件托盘70,其能够将至少两个部件定位在由低能电子束源在消毒室112内建立的消毒云。可以使用运送源(未示出)、诸如传送带或者分度台,将部件托盘70从分离区域运送至消毒室112。
在图20所示的实施例中,消毒室112优选地作为更大的消毒间110内的中央隔间。优选的消毒系统包括两间:袋消毒间110a(图21)和小瓶/器械消毒隔间110b(图23)。两间110a和110b目的相同,因此下面描述将仅参照袋的消毒间110a。然而,在两间之间存在关键不同,这些不同将在此文本和附图中指出。
两间110a和110b被分成了三个室:预先消毒室114;消毒室112和消毒后室116。每个室都具有一组入口门和一组出口门。预先消毒室114的出口门131还作为消毒室112的入口门。同样的,消毒室的出口门132还用作消毒后室116的出口门。这些门优选地是横向滑动门,它们由例如对传感器(未示出)和控制系统(未示出)响应的液压机构致动。在空间允许时,门可以被设计成竖直地或水平地滑动。也可以使用单面板或者两部分的面板。自动系统设计相关领域的技术人员将会很好理解这些加入的特征和它们的应用。
四组室门130、131、132和133具有一英寸前端,其具有四分之一英寸不锈钢做的外侧衬里。类似的,室壁134建立以防止外部的人员突然暴露在电子束源产生的辐射下。使用更高的能量源可能会需要额外的屏蔽。消毒室112应当还包括合适的通风装置,因为这些能量源产生臭氧。
如图21和22所示,电子束源优选地通过两个相对定位的低能电子束管102而提供。现在,仅有少量的供应商供应这种管子。管和束的尺寸以及输出操作参数只是几个可以引导选择的因数。本实施例用的优选电子束管宽度近似10英寸,高度2英寸,并在从60到125KeV的范围下工作。其它合适的电子束管可以存在,且本领域技术人员将会理解用以将这些电子束管应用在本系统中所必需的修改。
通过引导相对电子束管102在袋托盘70a或者小瓶/器械托盘70b的托盘窗口41的位置上所产生的电子云,电子“淹没区”被建立在考虑部件连接的地方上。淹没区内的连接确保了在部件的每一个角落、裂缝和表面处保持消毒。也就是说,即使没有消除掉,也使并置表面所造成的阴影降到最小。
虽然使用两个电子束源对于本发明是优选的,但是在一些应用中可以考虑使用单个电子束。例如,部件可以在所产生的电子云内旋转,以实现消毒,或者电子束源可以绕部件旋转,以实现同样的效果。另外,可以以阵列方式使用任意数量的电子束,进一步解决非常复杂的连接或者奇形部件的阴影。
现在参照图20A-C,可以更容易地理解托盘70通过三间110的运动。从完全空的消毒间110开始,打开预先消毒室114中的门130。这里,第一部件托盘70’保持直至门130又被关闭。然后,在门131打开且第一部件托板70’进入消毒室112后,门131完全关闭,且门130打开,以允许第二部件70”进入,如图20A所示。此时,第一部件托盘70’进行消毒,其细节将在下面更详细描述。然后,像以前一样,门130关闭,同时门132打开,以允许第一部件托盘70移动到消毒后室116。同时,门131打开,允许第二部件托盘70”进入消毒室112,如图20B所示。然后,门131和132关闭。在此点上,如图20C所示,第一部件托盘70’位于消毒后室116,作为保持室,而第二部件托盘70”位于消毒室112。
还参照图20C,门130和133打开,允许第三部件托盘70移动进入预先消毒室114,而允许第一部件托盘70’移动到消毒后室116外。然后门130和133关闭。消毒间110然后将会装有位于消毒室112的第二部件托盘70”和位于预先消毒室114的第三部件托盘70。然后,重复从打开门130和133的顺序,直至所有部件托盘都穿过消毒间110的所有的三个室。在这一发展下,保持了所有时刻电子源任一侧上的门密封,从而提供了全部时间的阻挡从消毒室偏离辐射的逃逸。自然的,可以设计出其它的顺序,以实现这一重要的安全防范。
托盘的运动受三个独立传送器表面120、122和124控制。第一传送器表面120负责接收系统来的托盘并将该托盘运送到预先消毒室114中。该第一运送器表面120和第二运送器表面122一起工作,将托盘运送到消毒室112中。消毒后,该第二运送器表面122和第三运送器表面124协作,将托盘定位在消毒后室116内。最后,第三运送器表面124将托盘运送到系统中,以便于继续处理。在替换通过室的换位下,可以对所用的传送器表面的数量做出改变。本领域技术人员将会理解如何使托盘的换位与应当变化的传送器表面的运动相互关联。
在消毒室112内,参照图21-23,袋托盘70a(图21)或者小瓶/器械托盘70b(图23)定位在两个电子束源102之间。此时,如图21所示,快门136处于关闭位置。快门136为液体冷却钢板,用来在组件消毒和连接前后挡住电子束窗口。与室门一样,需要快门136厚得足以提供适当的防护,因此优选地在快门136的中央部分没有任何冷却元件(这可能需要空心板),其中实现电子束的直接入射。
参照图21和22,快门135被联接在气动致动器140上,其响应控制器(未示出)。如果想要的话,则可以使用单个控制器控制室门130、131、132和133、传送器表面120、122和124以及快门136。在室门131和132处于关闭位置(图20A)后,合适的控制器可以起动气动致动器140,升起快门136(图22)。在此点上,部件暴露受部件位于所产生的电子云内的位置(优选位于电子淹没区内)以及暴露时间(即快门升起的时间)的控制。
与小瓶/器械托盘70b不同,袋托盘70a具有额外的热防护,以保护部件的产品不受电子束照射。参照图21和22,液体冷却双面板热护罩142开始定位在消毒室112内。热护罩142的下部144用来防护袋部件,而上部146用来防护小瓶/器械部件70b。随着袋托盘70a的袋保持部分被致动器140升高,以在消毒处理的连接步骤中升高袋部件,热护罩142的下部144同时移动,保持袋部件的护罩。在两个部件搭扣连接在一起后,下部144抵靠热护罩142的上部146。该热护罩142仅在快门136关闭后并同时随着致动的袋托盘70a的袋保持部分的返回而缩回(即下部144返回到它的开始位置)。
参照图20C,然后托盘70被移到用于保持的消毒后室116,如上述。从消毒后室116处,托盘70能够移动到其它台,以便于进一步处理。
在优选实施例中,预选百分比率(例如10%、30%、50%等)的消毒托盘可以送到检验台(未示出)。在该检验台上,剂量计保持器40a和40b可以分别从托盘70a和70b上取下。然后可以拆开保持器,以便于获取剂量计30。当然,剂量计30应当用必需的工具(例如镊子)处理,以防止污染。
在从剂量计保持器40上取下后,每个剂量计30所吸收的辐射可以测出。如果测出的辐射剂量水平处于实现每个剂量计所需要的或者期望的SAL上或者以上,则相应的托盘可以被确定为“消毒”有效。确定部件消毒有效的能力是存在于托盘上的剂量计膜和部件之间的确定了的相关关系的结果。
托盘可以再进入组件处理。剂量计保持器40现在可以装有新的剂量计,并重新联接在合适的托盘70上,以重复该处理。
尽管已经参照优选实施例显示并描述了本发明,但是本领域技术人员将理解在背离所附权利要求限定的本发明的要旨和范围的情况下,可以对本发明做出各种形式和细节修改。
Claims (62)
1.一种用于检验通过低能电子束对消毒系统内的若干部件进行消毒的方法,包括以下步骤:
将在低能电子束消毒系统内待消毒的部件放在部件托盘上;
确定施加给该部件时产生所期望的消毒保证水平(SAL)的最小消毒剂量;
将一指示器联到该消毒系统内,作为用来指示获得至少最小消毒剂量的部位;
建立上述部件处的消毒剂量和该指示器处的剂量之间的相互关系;
使上述部件和指示器暴露在一消毒源下;
确定该指示器处的剂量;以及
根据在相关的指示器处确定的剂量,确定在上述部件处所得到的消毒剂量的效力。
2.如权利要求1所述的方法,其中建立相互关系的所述步骤包括以下步骤:
将所述部件和多个指示器暴露在一消毒源下,用以模仿消毒系统的工作;
测量在每个指示器处所接受到的剂量;以及
重复上述暴露步骤和测量步骤,直至找到所述部件处所测得的消毒剂量与至少一个指示器处所测得的消毒剂量之间的数学关系。
3.如权利要求1所述的方法,其中将所述部件和指示器暴露在一消毒源下的所述步骤的消毒剂量受电子束控制。
4.如权利要求1所述的方法,其中确定指示器处的剂量水平的所述步骤通过传感器实现。
5.如权利要求4所述的方法,其中所述传感器为辐射剂量计。
6.如权利要求1所述的方法,其中所述指示器包括剂量计。
7.如权利要求1所述的方法,其中所述指示器包括多个剂量计。
8.如权利要求1所述的方法,其中所述指示器以可取下的方式固定在所述部件托盘上。
9.如权利要求7所述的方法,其中所述剂量计以可取下的方式固定在所述部件托盘上。
10.一种辐射消毒检验器械,包括:
剂量计;
第一剂量计座,其包括内表面,在该内表面中限定有空腔,其中该剂量计被定位在该空腔内。
11.如权利要求10所述的辐射消毒检验器械,其中还包括:
第二剂量计座,其包括内表面,该内表面带有被构造成与所述第一剂量计座的空腔的内表面相抵靠的突出;以及
用以将第一剂量计座固定在第二剂量计座上以形成组件的机构。
12.如权利要求10所述的辐射消毒检验器械,其中还包括用以将第一剂量计座固定在辐射消毒部位上的机构。
13.如权利要求11所述的辐射消毒检验器械,其中还包括用以将所述组件固定在辐射消毒部位上的机构。
14.如权利要求13所述的辐射消毒检验器械,其中用以将第一剂量计座固定在第二剂量计座上的所述机构包括用以将所述组件固定在辐射消毒部位上的所述机构。
15.如权利要求11所述的辐射消毒检验器械,其中用以将第一剂量计座固定在第二剂量计座上的机构包括摩擦力。
16.如权利要求10所述的辐射消毒检验器械,其中第一剂量计座包括单个空腔。
17.如权利要求11所述的辐射消毒检验器械,其中第一剂量计座包括多个空腔,且第二剂量计座具有对应数量的、被构造成抵靠空腔的内表面的突出。
18.如权利要求11所述的辐射消毒检验器械,其中还包括在第一剂量计座或者第二剂量计座内限定出的通道,以允许辐射到达所述空腔。
19.如权利要求10所述的辐射消毒检验器械,其中还包括在第一剂量计座内限定出的通道,以允许辐射到达所述空腔。
20.如权利要求18所述的辐射消毒检验器械,其中所述通道的直径在从约4.45毫米(0.175英寸)到约7.37毫米(0.290英寸)之间的范围内。
21.如权利要求20所述的辐射消毒检验器械,其中所述通道的直径为约5.94毫米(0.234英寸)。
22.如权利要求18所述的辐射消毒检验器械,其中所述通道的深度在从约1.78毫米(0.070英寸)到约4.45毫米(0.175英寸)之间的范围内。
23.如权利要求22所述的辐射消毒检验器械,其中每个通道的深度均为约3.15毫米(0.124英寸)。
24.如权利要求17所述的辐射消毒检验器械,其中还包括在第一剂量计座或者第二剂量计座内限定出的多个通道,用以允许辐射到达每个空腔。
25.如权利要求24所述的辐射消毒检验器械,其中每个通道的直径在从约4.45毫米(0.175英寸)到约7.37毫米(0.290英寸)之间的范围内。
26.如权利要求25所述的辐射消毒检验器械,其中每个通道的直径为约5.94毫米(0.234英寸)。
27.如权利要求24所述的辐射消毒检验器械,其中每个通道的直径在从约1.78毫米(0.070英寸)到约4.45毫米(0.175英寸)之间的范围内。
28.如权利要求27所述的辐射消毒检验器械,其中每个通道的直径为约3.15毫米(0.124英寸)。
29.一种用于检验部件的消毒的系统,包括:
消毒室;
托盘部件,其被构造成用以将部件定位在该消毒室内;
剂量计保持器,其内装有剂量计,并且以可取下的方式固定在所述托盘部件上;
低能消毒源,其被构造成用以将消毒剂量传递到部件,并将相关的剂量传递到位于所述消毒室内的剂量计;
检验台,其用于测量位于消毒室内的剂量计所吸收的相关剂量。
30.如权利要求29所述的系统,其中还包括:定位在所述托盘部件上的至少两个部件;和位于消毒室内时驱动至少其中一个部件的致动器,以便于实现这些部件之间的连接。
31.如权利要求29所述的系统,其中所述剂量计保持器包括允许辐射到达所装的剂量计的通道。
32.如权利要求29所述的系统,其中所述检验台包括色度计。
33.一种辐射消毒检验器械,包括:
多个剂量计;以及
第一剂量计座,其包括内表面,在该内表面中限定有多个空腔,其中剂量计被定位在每个空腔内。
34.如权利要求33所述的辐射消毒检验器械,其中还包括:
第二剂量计座,其包括内表面,该内表面具有多个突出,每个突出都被构造成与第一剂量计座的多个空腔中的一个的内表面相抵靠;以及
用以将所述第一剂量计座固定在该第二剂量计座上以形成组件的机构。
35.如权利要求33所述的辐射消毒检验器械,其中还包括用以将第一剂量计座固定在辐射消毒部位上的机构。
36.如权利要求34所述的辐射消毒检验器械,其中还包括用以将所述组件固定在辐射消毒部位上的机构。
37.如权利要求36所述的辐射消毒检验器械,其中用以将第一剂量计座固定在第二剂量计座上的所述机构包括用以将所述组件固定在辐射消毒部位上的所述机构。
38.如权利要求34所述的辐射消毒检验器械,其中用以将第一剂量计座固定在第二剂量计座上的机构包括摩擦力。
39.如权利要求34所述的辐射消毒检验器械,其中还包括在第一剂量计座或者第二剂量计座内限定出的通道,以允许辐射到达所述空腔。
40.如权利要求33所述的辐射消毒检验器械,其中还包括在第一剂量计座内限定出的通道,以允许辐射到达所述空腔。
41.如权利要求39所述的辐射消毒检验器械,其中所述通道的直径在从约4.45毫米(0.175英寸)到约7.37毫米(0.290英寸)之间的范围内。
42.如权利要求41所述的辐射消毒检验器械,其中所述通道的直径为约5.94毫米(0.234英寸)。
43.如权利要求39所述的辐射消毒检验器械,其中所述通道的深度在从约1.78毫米(0.070英寸)到约4.45毫米(0.175英寸)之间的范围内。
44.如权利要求43所述的辐射消毒检验器械,其中每个通道的深度均为约3.15毫米(0.124英寸)。
45.一种用于检验部件的消毒的组件,该组件包括:
部件托盘,其被构造成用以支承至少一个部件,该至少一个部件的一部分需要消毒;
部件部位,其由需要消毒的所述至少一个部件的所述部分限定出,该部件部位需要一阈值消毒剂量,以实现对该至少一个部件的所述部分的消毒;以及
剂量计保持器,其被定位在该部件部位附近,并且具有至少一个剂量计,用以接收对应于该部件部位所接受到的消毒剂量的施加剂量。
46.如权利要求45所述的组件,其中所述部件托盘被构造成用以支承连接在一起以形成一组的至少两个部件,且该至少两个部件的一部分限定了所述部件部位。
47.如权利要求46所述的组件,其中第一部件托盘被构造成用以支承要被连接在至少一个其它部件上以形成多组部件的多个部件,且被连接以形成一组的每个部件的一部分均限定出一部件部位,以致于部件组的数量等于部件部位的数量。
48.如权利要求45所述的组件,其中,所述部件托盘包括用于控制由剂量保持器的剂量计所接受到的剂量的装置。
49.如权利要求48所述的组件,其中用于控制剂量计所接受到的剂量的所述装置包括位于剂量计保持器中的、具有一定直径和深度的孔。
50.如权利要求49所述的组件,其中所述孔的直径在从约4.45毫米到约7.37毫米之间的范围内。
51.如权利要求49所述的组件,其中所述孔的深度在从约1.78毫米到约4.45毫米的范围内。
52.如权利要求45所述的组件,其中所述剂量计保持器包括:
第一座,其具有在壁内限定出的、用以将剂量计装入其中的空腔;和孔,该孔具有一定直径和深度,其穿过位于该空腔的周边的壁;以及
第二座,其构造有配合部分,该配合部分被装配在第一座的空腔内,以致与其中的剂量计相抵靠。
53.如权利要求45所述的组件,其中所述剂量计保持器包括:
第一座,其具有在壁内限定出的、用以将剂量计装入其中的空腔;以及
第二座,其构造有配合部分,该配合部分被装配在第一区的空腔内,以致与其中的剂量计相抵靠;和孔,该孔具有一定直径和深度,其穿过该配合部分。
54.如权利要求47所述的组件,其中所述剂量计保持器包括:
第一座,其具有在壁内限定出的多个空腔,其中每个空腔都装有剂量计;以及
第二座,其构造有用于第一座的每个空腔的配合部分,以抵靠该空腔中的剂量计;和孔,该孔具有一定直径和深度,其穿过每个配合部分。
55.如权利要求54所述的组件,其中空腔的数量等于部件部位的数量。
56.如权利要求54所述的组件,其中空腔与部件部位的数量之比在从1∶1到4∶1之间的范围内。
57.如权利要求52所述的组件,其中所述第二座被构造成紧固在第一座上。
58.如权利要求52所述的组件,其中所述孔的直径和深度被选择成:使剂量计处的消毒剂量水平与部件固定部位处所期望的消毒剂量水平成比例。
59.如权利要求58所述的组件,其中所述孔的直径在从约4.45毫米到7.37毫米之间的范围内。
60.如权利要求58所述的组件,其中所述孔的深度在从1.78毫米到4.45毫米之间的范围内。
61.如权利要求45所述的组件,其中所述部件托盘包括1到10个部件部位和1到15个剂量计。
62.如权利要求47所述的组件,其中所述部件托盘包括1到10个部件部位和1到15个剂量计。
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- 2003-12-23 US US10/745,466 patent/US7641851B2/en not_active Expired - Fee Related
-
2004
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- 2004-12-01 AT AT04812618T patent/ATE554794T1/de active
- 2004-12-01 CN CNB2004800385051A patent/CN100556462C/zh not_active Expired - Fee Related
- 2004-12-01 EP EP04812618A patent/EP1708759B1/en not_active Not-in-force
- 2004-12-01 MX MXPA06006475A patent/MXPA06006475A/es active IP Right Grant
- 2004-12-01 CA CA2546846A patent/CA2546846C/en not_active Expired - Fee Related
- 2004-12-01 ES ES12159706.6T patent/ES2473315T3/es active Active
- 2004-12-01 AU AU2004311924A patent/AU2004311924B2/en not_active Ceased
- 2004-12-01 EP EP12159706.6A patent/EP2465544B1/en not_active Not-in-force
- 2004-12-01 WO PCT/US2004/040146 patent/WO2005065728A1/en active Application Filing
- 2004-12-01 PL PL04812618T patent/PL1708759T3/pl unknown
- 2004-12-01 ES ES04812618T patent/ES2386894T3/es active Active
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2009
- 2009-12-18 US US12/642,282 patent/US8022375B2/en not_active Expired - Lifetime
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN101678130B (zh) * | 2007-06-07 | 2013-06-19 | 伊西康公司 | 辐射敏感产品的灭菌剂量设定方法 |
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US20050135965A1 (en) | 2005-06-23 |
US7641851B2 (en) | 2010-01-05 |
AU2004311924A1 (en) | 2005-07-21 |
EP2465544B1 (en) | 2014-03-19 |
AU2004311924B2 (en) | 2010-06-17 |
CA2546846C (en) | 2012-08-28 |
AU2010219435B2 (en) | 2012-03-15 |
WO2005065728A1 (en) | 2005-07-21 |
PL1708759T3 (pl) | 2012-09-28 |
US20100140515A1 (en) | 2010-06-10 |
EP1708759B1 (en) | 2012-04-25 |
US8022375B2 (en) | 2011-09-20 |
ES2386894T3 (es) | 2012-09-05 |
CN100556462C (zh) | 2009-11-04 |
MXPA06006475A (es) | 2006-08-23 |
CA2546846A1 (en) | 2005-07-21 |
AU2010219435A1 (en) | 2010-10-07 |
ES2473315T3 (es) | 2014-07-04 |
EP2465544A1 (en) | 2012-06-20 |
JP2007516774A (ja) | 2007-06-28 |
EP1708759A1 (en) | 2006-10-11 |
ATE554794T1 (de) | 2012-05-15 |
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