CN103957955A - 包含残留屏障膜的抗菌成分 - Google Patents
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Abstract
本公开描述了示例性抗菌成分,所述抗菌成分可以与IV端口清洁帽、保护帽或鼻部去殖器装置结合起来使用。根据其它实施,本公开描述了所述抗菌成分通过在正被清洁的表面上发泡或起泡沫可以提供其与污染物发生接触的指示。根据其它实施,本公开描述了抗菌成分可以留下残留的膜或屏障,用来抑制已被清洁的表面的再污染。
Description
相关申请的交叉引用
本申请要求于2011年11月28日提交的、名称为“用于抗菌、免疫调节和抗肿瘤治疗的医疗装置和技术”的美国临时专利申请61/564,206的优先权,据此通过引用将其整体合并。
背景技术
当前,感染仍然是医疗产业的实际问题。通常,感染由血管内(IV)管线(例如,静脉内的、动脉内的等)的污染、注射部位或抽血部位(例如,从静脉、动脉或毛细血管)、导尿管、受伤部位、切口部位以及医疗设备中诸多其它感染源的污染所引起。例如,仅在美国的医院,中心静脉导管每年就引起估计250,000起血流感染,这导致了所消耗的财务资源和病人发病的大量成本。O'Grady MD等,Guidelines for thePrevention of Intravascular Catheter-Related Infections(血管内导管相关感染的预防指南),2011,卫生与公共服务部疾病控制中心。这些数字不包括由注射部位、抽血部位、非静脉导管或医疗设备中任何的其它众多污染源的污染所引起的感染。在注射器、IV管线以及其它器材被惯常地用于并再次用于多个不同病人的发展中国家,感染是个更加严重的问题。
附图说明
详细的描述参考附图予以阐明。在附图中,附图标记最左边的数字表示附图标记首次出现的附图的编号。不同附图中相同附图标记的使用指示相似或同一部件或特征。
图1示出了示例性端口清洁***,所述端口清洁***可以包括清洁帽,所述清洁帽具有携带抗菌成分的涂抹器材料。
图2A-图2C示出了示例性端口清洁及消毒***,其中,抗菌成分可以提供污染物的可视化指示。
图3A-图3C示出了示例性保护帽,其中,抗菌成分可以提供污染物的可视化指示。
图4示出了鼻部去殖器装置,可以用来输送抗菌成分。
具体实施方式
概述
本申请描述了减少和/或防止感染的方法。在一个方面,本申请描述了示例性抗菌成分,所述示例性抗菌成分可以单独使用或与一个或多个医疗设备结合使用,以对血管内(IV)管线端口、其它IV部件(例如,注射器、腔、阀(valve)等)、注射部位、抽血部位(例如,从静脉、动脉或毛细血管)、导管和/或导管***部位、受伤部位、切口部位、腹膜透析部位、膀胱或肾造口术部位、其它引流部位或易受感染的任何其它部位进行清洁和/或消毒。
示例性抗菌成分
在一个示例性实施中,可以与在此所描述的方法连起来使用的抗菌成分可以包括(例如)于2010年9月1日提交的美国专利申请12/874,188(Tennican等人名下的)中所描述的那些,在此通过引用将其合并。在这种情况下,抗菌成分可以包括水(H2O)、浓的无毒螯合剂(例如,乙二胺四乙酸EDTA(例如,二钠EDTA、二钠钙EDTA、镁EDTA、镓EDTA)或柠檬酸钠(或酸、盐、衍生物或其它形式的EDTA或柠檬酸钠))、短链一元醇(例如,具有分子式C2H5OH和实验式C2H6O的乙醇)、以及浓的小分子氧化剂(例如,过氧化氢(H2O2))。在一个具体的示例中,成分可以基本地由水、EDTA、乙醇以及过氧化氢构成。然而,在其它实施例中,其它抗菌成分可以与本申请所描述的装置结合起来使用。
取决于具体应用的需要,抗菌成分可以是(例如)液体形式或凝胶形式或泡沫状形式,并且可以与一个或多个载体或稀释剂结合。例如,在抗菌成分用作手部杀菌剂的应用中,抗菌成分可以是凝胶形式。再如,如果抗菌成分用作清洁剂、冲洗溶液或刺激剂,抗菌成分可以是液体形式。在这种情况下,多种组分的浓度(例如,所期望的消毒水平)可以取决于成分是否被直接应用到活组织或医疗装置,和/或是否避免对成分被直接或间接(例如,通过成分被应用或已被应用到的医疗装置)应用到的组织产生刺激。在另一个示例中,液体形式的抗菌成分可以被蒸发或喷涂,用于应用到病人的鼻腔通道或其它气道。又一个示例中,抗菌成分可以包括润滑剂(例如,甘油)、表面活性剂或乳化剂(例如,单月桂酸甘油酯(GML))等或与其结合,并被应用到***进病人身体的导管、气管导管、镜(scope)、仪器或其它设备。
示例性膜或屏障层
除了在应用时提供消毒以外,抗菌成分还可以提供抵抗污染的持久的屏障。例如,即使在成分中的易挥发组分(例如,水、酒精、过氧化氢等)已经挥发之后,螯合剂仍留在被处理的表面上(例如,端口、端口清洁/保护装置、手指、周围的组织等),作为提供抗菌的、抗真菌的或杀孢子的(例如,防止孢子萌发)、抗寄生物的、以及抗病毒的特性的屏障。通过剥夺细菌、孢子、寄生物以及病毒再生所需要素(例如,铁、镁和锰)的环境,螯合剂即使在抗菌成分的其它组分已经挥发之后仍能提供对污染的持久防御。而且,抗菌成分中的过氧化氢可以在抗菌成分所应用的材料(例如,硅材料)的表面上诱导电荷(charge),这使得材料更具抵抗细菌和其它微生物的能力。
图1示出了示例性IV端口清洁***100,所述IV端口清洁***100包括清洁帽102,所述清洁帽102具有携带抗菌成分(例如上文所描述的那些)的涂抹器材料104。清洁帽102可以用来清洁IV端口106。在示出的示例中,IV端口包括凹形连接件。然而,在其它实施例中,这种IV端口清洁***可以用于或适合于对凸形或连接件以及其它类型的IV和非IV端口和/或腔进行清洁。清洁帽102可以用来(例如)在将端口连接到互补的(complimentary)端口之前、在注射药物之前、在抽血之前或使用IV端口106之前对IV端口106进行消毒。在被消毒之后,抗菌成分的易挥发的组分随着时间的推移挥发掉,留下EDTA或者其它螯合剂的膜或屏障层108(如上文所描述的),它们提供了对污染的持久防御。
一旦被消毒,可以将保护帽(本图未示出)应用到IV端口106,以提供抵抗再污染的物理屏障。保护帽可以包含相同或不同的抗菌成分或其它成分。在一些实施中,保护帽可以牢固地与IV端口106联结并且可以将IV端口密封起来。如果保护帽中的抗菌成分随着时间的推移变干,保护帽仍包括EDTA或其它螯合剂的残留的屏障层,它们对污染提供进一步的防御。在其它实施例中,代替上文描述的其中一种抗菌成分,保护帽可以在其整个或部分的内表面和/或外表面简单地涂覆有EDTA或其它螯合剂的膜或屏障层。
尽管图1示出了包括清洁帽102的IV端口清洁***的一个实施例,但是,在其它实施例中,根据本公开,其它清洁装置也可以用来携带并应用抗菌成分。通过示例(非限制性的),可以使用的其它清洁装置,包括药棉块(pad)、棉签、湿巾、海绵或能携带抗菌成分的任何其它材料。进一步地,虽然图1示出了抗菌成分和帽***可以用来对IV端口进行清洁,但是,根据本公开的抗菌成分和清洁装置还可以对其它IV部件、注射部位、抽血部位、导管和/或导管***部位、受伤部位、切口部位、腹膜透析部位、引流部位或易受感染的任何其它部位进行清洁和/或消毒。
而且,除了它们的清洁、消毒和屏障特性以外,上文描述的抗菌成分可以包括一个或多个治疗用途,例如下文所描述的那些以及于2011年1月21日提交的、国际专利申请PCT/US2011/022150(Tennican等人名下的)中所描述的那些,在此通过引用将其合并。
示例性污染指示器
除了它们的清洁、消毒、屏障特性以及治疗用途,上文描述的抗菌成分提供了污染的可视化指示器,所述可视化指示器允许医疗提供者识别并清洁或替换被污染的器材以防止感染。下文将参考图2A-图2C以及图3A-图3C的示例性IV端口帽***对这种指示器的功能的细节进行描述。然而,抗菌成分的指示器功能不限于这种***,并且不论抗菌成分使用的***或过程都是可应用的。
图2A-图2C详细示出了图1的IV端口清洁和消毒***100。具体地,图2A示出了在使用之前的清洁帽102。如图2A所示,清洁帽102可以与保护盖200一起使用,所述保护盖200使清洁帽102的内部保持在无菌状态。额外地或替代地,清洁帽102可以封装在另一无菌包装件(本图未示出)内,以使整个清洁帽102在使用之前保持在无菌状态。为了用清洁帽102对IV端口106进行清洁,可以将保护性密封移除,从而露出帽102的内部,如图2B所示。然后,将清洁帽102置于IV端口106上并进行扭动,或用清洁帽102对IV端口106进行擦拭和清洁。具体地,通过抵住IV端口106扭动并按压清洁帽102,携带抗菌成分的涂抹器材料104可以用来擦拭IV端口106的外部表面。
如果IV端口106被细菌、孢子、寄生物、病毒、体液或其它污染物污染,抗菌成分将开始发泡或起泡沫202,从而提供了污染的可视化指示器。发泡或起泡沫的行为是由过氧化氢与细菌、孢子、寄生物和病毒发生反应而引起的。具体地,使抗菌成分中的过氧化氢起泡沫的污染物的酶包括(但不限于)过氧化氢酶、超氧化物歧化酶(SOD)、谷胱甘肽过氧化物酶、过氧化物酶以及其它氧化物酶等。口咽的、呼吸的、子宫颈***的分泌和血清也包含使抗菌成分起泡沫的过氧化氢反应物或酶。EDTA稍微减弱了这些反应。然而,试验显示了这种减弱是轻微的,并且不会削弱抗菌成分可视化地指示存在污染的能力。例如,根据本申请,具有过氧化氢酶的金黄色葡萄球菌(MRSA)和具有SOD的绿脓杆菌与抗菌成分接触时都产生丰富的泡沫。响应于与红血球中血红蛋白的铁、或白血球及体液中过氧化物酶的芬顿(Fenton)反应,过氧化氢也会产生泡泡或泡沫。泡泡形成的大小和比率可以指示污染的水平,从而给医务人员器械被污染以及器械被污染的相对程度的可视化指示(例如,更多或更大的泡泡/泡沫指示更多污染)。基于该指示,医务人员可以决定器械需要进一步清洁和/或替换,以避免感染。
图3A-图3C示出了示例性保护帽300,所述保护帽300在一些实施例中可以与图1和图2A-图2C的清洁帽102结合起来使用。在IV端口106被清洁之后,可以将保护盖302从保护帽300移除,从而露出保护帽的内部,如图3A和图3B共同所示的。正如与清洁帽102相同,保护帽300可以封装在另一无菌包装件(本图未示出)内,以使整个保护帽300在使用之前处于无菌状态。
然后,可以将保护帽300应用到IV端口106,以提供抵抗再污染的物理屏障,如图3C所示。保护帽300相比于清洁帽102可以包含相同或不同的抗菌成分或其它成分。当保护帽300联结到IV端口106时,如果发生发泡或起泡沫304现象,发泡或起泡沫将为医务人员提供IV端口106仍被污染且需要进一步清洁和/或替换的可视化指示器。
在一些实施例中,清洁帽102、保护帽300或这二者中的抗菌成分可以包含用作进一步增强污染的可视化指示的染料或着色剂。倘若有,清洁帽102中的染料或着色剂相比于保护帽300中的可以具有相同或不同的颜色。例如,染料或着色剂的颜色可以匹配各个帽的颜色。在另一个示例中,染料或着色剂的颜色可以与各个帽的颜色形成对比。
示例性鼻/口咽装置
图4示出了鼻部去殖器(decolonizer)装置400,所述装置400可以用来将抗菌成分(例如在此所描述的这些)输送到病人的鼻腔通道。本实施例的抗菌成分可以包含酒精和过氧化氢的浓度,由于鼻腔通道更加敏感的性质,该浓度低于端口和部位清洁及消毒应用中所使用的浓度。鼻部去殖器装置400可以将抗菌成分应用于MRSA、或其它耐药菌、载体的鼻和口咽的通路的区域(和/或在选择性的外科植入物之前)。抗菌成分可以作为喷涂物或凝胶而被配发。
如图4所示,鼻部去殖器装置400包括储液器402和配发喷口404,所述储液器402用来容纳抗菌成分,所述配发喷口404具有一定的大小和形状,以至少部分地适合于病人的鼻腔通道。配发喷口404可以由相对软的、柔韧的材料制成,在一些实施中,配发喷口404可以作为凝胶或液体的涂抹器或传播器,以进入鼻子和/或鼻腔通道的内表面。使用之前,配发喷口404由脆弱凸片406盖住,所述脆弱凸片406将鼻部去殖器装置400气密密封起来。
不同大小、形状、材料和配置的鼻部去殖器400或其它医疗装置(具有用于包含在储液器中的喷涂物或凝胶的配发喷口)可以用来向体内的部位或难于够着的部位输送抗菌的、免疫调节的和/或肿瘤的治疗。
结论
尽管本申请对具有具体结构特征和/或方法步骤的实施例进行了描述,但是,可以理解的是,权利要求不一定被限制到所描述的具体特征或方法步骤。相反,具体特征和方法步骤仅仅是一些落入本申请权利要求范围的解释性实施例。
Claims (20)
1.一种方法,包括:
识别要被去污的表面;
将医疗涂抹器应用于所述表面,其中,所述医疗涂抹器包括:
帽装置,所述帽装置包括圆柱形的腔,所述圆柱形的腔具有泡沫状***物;或包括储液器的鼻部去殖器装置;以及
抗菌成分,所述抗菌成分在所述帽装置的泡沫状***物内或所述鼻部去殖器装置的储液器内,其中,所述抗菌成分包括水、酒精、过氧化物或过氧化物生成剂、以及螯合剂;以及
接收所述抗菌成分与所述表面上的一个或多个污染物接触的指示。
2.根据权利要求1所述的方法,其中,所述一个或多个污染物包括一个或多个细菌、孢子、寄生物、病毒、体液或其结合中的至少一个。
3.根据权利要求2所述的方法,其中,所述一个或多个污染物包括金黄色葡萄球菌(MRSA)、绿脓杆菌或其它耐药菌。
4.根据权利要求1所述的方法,其中,所述抗菌成分进一步包括:
大约5mg/ml至大约50mg/ml的乙二胺四乙酸(EDTA);
按体积计,最多大约70%的乙醇;
按体积计,最多大约7.5%的过氧化氢;以及
水。
5.根据权利要求1所述的方法,其中,所述抗菌成分是液体或凝胶的形式。
6.根据权利要求1所述的方法,其中,所述螯合剂的量使得水、酒精和过氧化物消散后,所述表面上仍有残留。
7.根据权利要求1所述的方法,其中,接收所述抗菌成分与所述表面上的一个或多个污染物接触的指示包括起泡沫或发泡。
8.根据权利要求1所述的方法,其中,要被去污的表面包括人体组织或医疗设备上的区域。
9.一种提供抵抗污染的屏障的方法,包括;
识别要被保护的表面;
将抗菌试剂应用到所述表面,其中,所述抗菌试剂包括水、低分子量酒精、过氧化物或过氧化物生成剂、以及螯合剂;
其中,所述螯合剂的量使得水、低分子量酒精、过氧化物或过氧化物生成剂蒸发后,所述表面上仍有残留。
10.根据权利要求9所述的方法,其中,要被保护的表面包括人体组织或医疗设备上的区域。
11.根据权利要求9所述的方法,其中,所述抗菌试剂进一步包括:
大约5mg/ml至大约50mg/ml的乙二胺四乙酸(EDTA);
按体积计,最多大约70%的乙醇;
按体积计,最多大约7.5%的过氧化氢;以及
水。
12.根据权利要求9所述的方法,其中,所述抗菌试剂是液体或凝胶的形式。
13.根据权利要求9所述的方法,其中,所述螯合剂留在所述表面上抑制了细菌、孢子、真菌、寄生物和病毒的繁殖能力。
14.对表面上的一个或多个污染物给出可视化指示的方法,包括:
确定要被去污的一个或多个表面;
将抗菌试剂应用到所述表面,其中,所述抗菌试剂包括水、低分子量酒精、过氧化物或过氧化物生成剂、以及螯合剂;以及
接收所述抗菌试剂与所述表面上的一个或多个污染物发生接触的指示。
15.根据权利要求14所述的方法,其中,要被去污的表面包括人体组织或医疗设备上的区域。
16.根据权利要求14所述的方法,其中,所述抗菌试剂进一步包括:
大约5mg/ml至大约50mg/ml的乙二胺四乙酸(EDTA);
按体积计,最多大约70%的乙醇;
按体积计,最多大约7.5%的过氧化氢;以及
水。
17.根据权利要求14所述的方法,其中,接收所述抗菌试剂与所述表面上的一个或多个污染物发生接触的指示包括可视化指示,例如在所述表面上起泡沫或发泡。
18.根据权利要求14所述的方法,其中,所述一个或多个污染物包括一个或多个细菌、一个或多个孢子、一个或多个寄生物、一个或多个病毒、一个或多个体液中的至少一个。
19.根据权利要求18所述的方法,其中,所述一个或多个污染物包括金黄色葡萄球菌(MRSA)、绿脓杆菌或其它耐药菌。
20.根据权利要求14所述的方法,其中,所述抗菌试剂中螯合剂的量不会抑制所述抗菌试剂与所述表面上的一个或多个污染物发生接触的指示。
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