CN105268701B - 从表面除去生物膜的方法 - Google Patents
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Abstract
容纳浸渍有抗菌消毒剂的泡沫材料擦拭体的擦洗刷先被放置在阴式鲁尔接口之上,其中擦拭体的环形部分被靠在鲁尔接口上压紧,并且擦拭体的中央部分进入所述鲁尔接口的通道以实现与所述擦拭体表面的完全接触。然后,所述擦拭体在阴式鲁尔接口上旋转一足以基本上除去被擦拭体接触的鲁尔接口表面上的生物膜的时间。
Description
本申请是2009年3月30日递交的申请号为200980120104.3、发明名称为“从表面除去生物膜的方法”的发明专利申请的分案申请。
本发明涉及从表面除去生物膜的方法。更具体地,本发明涉及从导管除去生物膜的方法。
本发明提供一种从表面除去生物膜的方法,所述方法包括步骤:提供至少一个基体,其特征在于,所述基体具有足以刮入在一表面上的生物膜的粗糙度、用于捕获其中的生物膜刮屑的多个腔和其中的抗菌消毒剂;以及移动所述基体经过其上具有生物膜的表面一足以基本上除去所述生物膜的时间。
其中,所述移动基体的步骤的特征在于,压力由所述基体施加到所述表面上。
其中,所述基体是半闭孔亲水性聚氨酯医用级泡沫。
其中,所述抗菌消毒剂是包含从2%到5%葡萄糖酸氯己定的水溶液。
本发明还提供一种从具有外周表面和中央通道的阴式鲁尔接口除去生物膜的方法,所述方法包括步骤:提供擦洗刷,所述擦洗刷包括限定至少一个腔的壳体、设置在所述腔中的泡沫材料擦拭体和在所述擦拭体中的抗菌消毒剂;将所述擦洗刷以同心方式放置在所述阴式鲁尔接口的所述外表面之上,其中所述擦拭体以围绕的方式被压紧在所述壳体和所述鲁尔接口之间,以实现所述擦拭体与所述外表面的完全接触;以及其后,相对于所述阴式鲁尔接口的所述外表面旋转所述擦洗刷一足以基本上除去在所述外表面上的生物膜的时间。
其中,所述阴式鲁尔接口的所述外表面在所述外表上具有外部螺纹,并且其中所述擦洗刷被拧在所述外表面上并且与所述外部螺纹的形状相一致,以接触所述外部螺纹的表面。
所述方法还包括在所述旋转所述擦洗刷的步骤之后,使所述擦拭体滑出所述阴式鲁尔接口的步骤。
本发明还提供一种从具有外周表面和中央通道的阴式鲁尔接口除去生物膜的方法,所述方法包括步骤:提供擦洗刷,所述擦洗刷包括限定腔的壳体、设置在所述腔中的泡沫材料擦拭体和在所述擦拭体内的抗菌消毒剂,所述擦拭体包括用于包围所述阴式鲁尔接口的所述外表面的环形部分和在所述环形部分内的用于插入所述阴式鲁尔接口的所述中央通道的中央部分;将所述擦洗刷以同心方式放置在所述阴式鲁尔接口的所述外表面之上,其中所述擦拭体的所述环形部分以围绕的方式被压紧在所述壳体和所述鲁尔接口之间,以实现所述擦拭体与所述外表面的完全接触,并且所述擦拭体的所述中央部分被压紧在所述阴式鲁尔接口的所述中央通道内;以及其后,相对于所述阴式鲁尔接口旋转所述擦洗刷一足以基本上除去所述外表面上的和来自被所述擦拭体接触的所述中央通道的生物膜的时间。
其中,所述擦拭体相对于所述阴式鲁尔接口旋转从六次到十次。
其中,所述擦拭体相对于所述阴式鲁尔接口旋转八次。
其中,所述擦拭体具有一表面,所述表面的特征在于具有足以刮入在所述基体上的生物膜并且从所述基体除去所述生物膜刮屑的粗糙度,并且其特征还在于具有用于捕获在所述基体中的所述刮屑的多个腔。
其中,所述擦拭体是半闭孔亲水性聚氨酯医用级泡沫。
其中,所述抗菌消毒剂是包含2%葡萄糖酸氯己定的水溶液。
本发明还提供一种微生物擦洗刷,包括:壳体,所述壳体在所述壳体的一侧上限定第一腔并且在其相对侧上限定第二腔;设置在所述第一腔中的泡沫材料的第一擦拭体;设置在所述第二腔中的泡沫材料的第二擦拭体;在每个所述擦拭体中的抗菌消毒剂;第一盖体,所述第一盖体可移除地安装在所述壳体上,用以密封所述第一腔和所述第一腔中的所述第一擦拭体;以及第二盖体,所述第二盖体可移除地安装在所述壳体上,用以密封所述第二腔和所述第二腔中的所述第二擦拭体。
其中,所述第一擦拭体包括用以包围阴式鲁尔接口的外表面的环形部分和用以插入所述阴式鲁尔接口的中央通道、在所述环形部分内与所述环形部分同中心的中央部分,并且所述第二擦拭体包括用以包围阴式鲁尔接口的外表面的环形部分和用以插入所述阴式鲁尔接口的中央通道、在所述环形部分内与所述环形部分同中心的中央部分。
其中,所述第一擦拭体是高孔隙率的半闭孔低密度亲水性聚氨酯医用级泡沫,并且所述第二擦拭体是低孔隙率的半闭孔中密度亲水性聚氨酯医用级泡沫。
其中,所述抗菌消毒剂是包含从2%到5%葡萄糖酸氯己定的水溶液。
其中,在所述第一擦拭体中的所述抗菌消毒剂较之于在所述第二擦拭体中的所述抗菌消毒剂具有更高浓度的葡萄糖酸氯己定。
本发明还提供一种从具有外周表面的阴式鲁尔接口除去多个生物膜层的方法,所述方法包括步骤:提供擦洗刷,所述擦洗刷包括限定一对相对设置的腔的壳体、设置在所述一对腔的每个所述腔中的泡沫材料擦拭体和在每个所述擦拭体中的抗菌消毒剂;将所述擦洗刷以同心方式放置在所述阴式鲁尔接口的所述外表面之上,其中在一个所述腔中的所述擦拭体以围绕的方式被压紧在所述壳体和所述鲁尔接口之间,以实现所述擦拭体与所述外表面的完全接触;其后,相对于所述阴式鲁尔接口的所述外表面旋转所述擦洗刷一足以从所述外表面除去至少一个生物膜层的时间;其后,将所述擦洗刷以同心方式放置在所述阴式鲁尔接口的所述外表面之上,其中在另一个所述腔中的所述擦拭体以围绕的方式被压紧在所述壳体和所述鲁尔接口之间,以实现所述擦拭体与所述外表面的完全接触;以及其后,相对于所述阴式鲁尔接口的所述外表面旋转所述擦洗刷一足以从所述外表面除去任何剩余的生物膜层的时间。
几乎所有的微生物都生存在复杂的菌落中,所述复杂的菌落埋置在自身产生的外聚合物基质的生物膜中。生物膜允许微生物附着到任何表面(有生命的或无生命的)。所述微生物在生物膜内的适应性和遗传性变化使它们抵抗所有已知的抗微生物剂。因此,用来抗击急性感染的诊断和治疗策略对于根除与医疗设备的生物膜有关的感染或慢性生物膜疾病是不起作用的。现今,与脉管导管有关的血行感染是最严重和代价最高的与健康护理相关的感染。
与导管有关的血行感染源自导管的外腔或内腔表面上生物膜的形成。微生物的进入点是皮肤(外腔)以及给药系统的任何接入端口或断开位点。
接入位点的消毒是针对微生物进入内腔导管表面的预防性干预。目前,出于这个目的,尽管没有应用于把注意力放在最佳防腐(施加方法或施加持续的时间)的标准,酒精(异丙醇)制备片普遍地被用在临床实践中。接入端口和无针连接器的表面在构造上是高度可变的。
因此,本发明的目的在于,在进入之前,消毒任何类型的接入(access)系统的表面。
本发明的另一个目的在于,从表面并且尤其是从阴式鲁尔接口(female luer)或类似导管的表面基本上除去生物膜。
简单地说,本发明提供从表面除去生物膜的方法,所述方法包括步骤:提供基体(substrate),所述基体的特征在于具有足以刮去掉表面上的生物膜的粗糙度、多个用以捕获生物膜刮屑的腔或孔和在所述腔或孔中的抗菌消毒剂;以及以足以基本上除去所述生物膜的次数移动基体经过在其上具有生物膜的表面。
在基体多次移动经过包含生物膜的表面期间,施加压力以促进基体在所述生物膜上的擦洗动作。
所述基体在导管(例如阴式鲁尔接口)上是尤其有用的,所述导管具有能够变成细菌的生长、并且尤其是生物膜的生长的表面的位点。
优选使用的基体是半闭孔(semi-closed)亲水性聚氨酯医用级泡沫。
在一个实施方案中使用了2007年4月2日递交的待审美国专利申请号11/732,075中描述的擦洗刷,所述专利的公开内容通过引用被并入本文。在这个方面,擦洗刷包括限定腔的壳体、设置在所述腔中的泡沫材料的擦拭体和在所述擦拭体中的抗菌消毒剂。此外,盖体可移除地安装在壳体上,用以密封所述腔以使腔以及其中的擦拭体维持在无菌状态直到准备使用。
依据本发明,擦洗刷以同心方式被放置在阴式鲁尔接口的外表面之上,其中擦拭体以围绕的方式被压紧在壳体和鲁尔接口之间,用以实现擦拭体与所述外表面的完全接触。之后,擦洗刷相对于阴式鲁尔接口的外表面旋转一足以基本上除去所述外表面上的生物膜的时间。
实验已经显示,对于常规尺寸的阴式鲁尔接口来说,为了基本上除去生物膜,擦洗刷相对于所述阴式鲁尔接口的旋转数在从6到10转的范围内,并且优选8转。
大家知道,擦洗刷的动作是这样的以致于有效地除去生物膜表面上的细菌,在随后的旋转是刮入(scrape into)生物膜,由此将生物膜刮屑除去进入擦拭体的腔(孔)。一旦完成旋转数,基本上所有的生物膜从被擦拭体接触的鲁尔接口表面刮下,并且被保持在擦拭体的腔(孔)内。
在擦拭体已经在阴式鲁尔接口上旋转过之后,所述擦拭体可以从阴式鲁尔接口滑出并且被丢弃。
在一实施方案中,擦洗刷的擦拭体包括用以包围阴式鲁尔接口外表面的环形部分和用以插入阴式鲁尔接口的中央通道内的内中央部分,类似的方法按照上面所描述的被实施。在这种情况下,擦洗刷又是以同心方式被放置在阴式鲁尔接口的外表面之上,其中环形部分以围绕的方式被压紧在擦洗刷的壳体和鲁尔接口之间,以实现擦拭体与外表面的完全接触,同时擦拭体的中央部分被压紧在阴式鲁尔接口的中央通道内。在足够的旋转次数已经实现了除去或基本上除去生物膜之后,擦洗刷可以从阴式鲁尔接口被移除并且丢弃。
在阴式鲁尔接口具有外部螺纹的地方,为了接触阴式鲁尔接口的表面,擦洗刷被拧在所述外表面上并且与所述外部螺纹的形状相一致。这样,阴式鲁尔接口外表面上的所有角落和缝隙都可以被擦拭体擦洗。
也可以使用在壳体的相对侧上具有一对腔的微生物擦洗刷,其中每个腔容置其中带有抗菌消毒剂的泡沫材料擦拭体。如上所述,盖体被可移除地安装在壳体上以密封每个各自的腔以使所述腔以及其中的擦拭体维持在无菌状态直到准备使用。
该实施方案在从已使用了延长的时间段的阴式鲁尔接口除去多层生物膜时是尤其有用的。在这样的情况下,已知的是,多层生物膜将在阴式鲁尔接口的表面上累积。
多腔壳体的使用允许用户将擦拭体中的一个施用到阴式鲁尔接口以除去至少一些生物膜层,随后使用第二擦拭体除去剩余的生物膜层。
多腔擦洗刷的一个优点在于,擦拭体可以由不同组合物制成。例如,一个擦拭体可以是高孔隙率的低密度亲水性聚氨酯医用级泡沫,而另一个擦拭体是低孔隙率的中等密度亲水性聚氨酯医用级泡沫。再有,一个擦拭体可以被提供有较之于另一个擦拭体更高的消毒剂浓度。使用具有较高粗糙度的擦拭体首先允许大部分的生物膜被除去。较不粗糙的擦拭体的后续擦拭应导致剩余的生物膜层或多个生物膜层被除去。
结合附图,从以下详细的说明中,本发明的这些以及其他的目的和优点将变得更明显,其中:
图1说明依据本发明所使用的微生物擦洗刷的透视图;
图2说明图1擦洗刷的横截面视图;
图3说明依据本发明,在擦洗所述接口期间,在阴式鲁尔接口的端部上的擦洗刷的横截面视图;
图4示意性地说明在导管表面上的生物膜;以及
图5说明依据本发明,具有一对相对设置的腔和擦拭体的擦洗刷的横截面视图。
参照图1,擦洗刷10以如在待审美国专利申请11/732,075中所描述的方式被构造,所述专利通过引用被并入本文。
参照图2,擦洗刷10包括限定腔12的壳体11、设置在腔12中的泡沫材料擦拭体13和在擦拭体13中的抗菌消毒剂。
擦拭体13包括用以包围(envelop)阴式鲁尔接口15(参见图3)外表面的环形部分14和在环形部分14内的、用以插入阴式鲁尔接口15的中央通道17的中央部分16。
擦拭体13是基体,其特征在于具有足以刮去表面上的生物膜的粗糙度,并且具有多个腔(孔),用以捕获其中的生物膜刮屑。通过实施例的方法,泡沫材料可以是低密度到中密度的泡沫,具有达每立方英尺5磅的密度,其中平均核径(core size)为0.013英寸。
采用的抗菌消毒剂可以是任何合适的溶液,例如,包含从2%到5%葡萄糖酸氯己定(CHG)的水溶液,并且尤其是3.15%CHG溶液、4%CHG溶液和5%CHG溶液。
参照图4,阴式鲁尔接口15的表面被示出在其上具有生物膜17。在这个方面,生物膜17覆盖直接形成在阴式鲁尔接口15的表面上的细菌层18,并且生物膜17本身被细菌层19覆盖。
参照图3,为了使阴式鲁尔接口15的表面是防腐的,擦洗刷10以同心方式被放置在阴式鲁尔接口15的外表面之上,其中擦拭体13的环形部分14以围绕的方式被压紧在壳体11和鲁尔接口15之间以实现擦拭体13与外表面的完全接触,并且擦拭体13的中央部分16被压紧在阴式鲁尔接口15的中央通道17内。之后,为了除去在鲁尔接口15的外表面上的暴露的细菌层19、基本上生物膜17的全部和被完全覆盖的细菌层18,以及除去被擦拭体13接触的来自鲁尔接口15内的中央通道17的细菌层和生物膜,擦洗刷10相对于阴式鲁尔接口15旋转从6到10次的次数,并且优选是8次。
在擦洗刷13于阴式鲁尔接口15上旋转期间,擦洗动作在压挤下发生。在擦洗刷13的最初的转圈(turns)期间,在生物膜顶部上的细菌层19被除去。擦洗刷13的后续转动刮入并且除去生物膜17。擦洗刷13最后的转圈除去位于现在除去的生物膜17下方的细菌层18。
擦拭体13的泡沫材料的粗糙度和压挤的结合用来沿所述泡沫的孔或腔的边缘刮去生物膜17,同时将刮屑捕获在所述泡沫的孔或腔中。
在鲁尔接口15具有外部螺纹或内部螺纹的地方,擦拭体13的泡沫材料的压挤用于确保擦拭体13与要使其防腐的表面完全接触。因此,泡沫材料屈服以与要被清洗的带螺纹的表面相一致,以使所有的角落和缝隙都可以被擦拭。
如在图1和2中所说明的,盖体20可移除地安装在壳体11上用以密封腔12,以使腔12和其中的擦拭体13维持在无菌状态直到准备使用。
参照图5,其中类似的编号标示如上类似的部分,擦洗刷10’包括限定一对相对设置的腔12、12’的壳体11’,每个腔包含擦拭体13、13’。正如所说明的,与上面描述的相同,每个擦拭体13、13’具有环形部分14、14’和中央部分16、16’。
在壳体11’的一侧上的擦拭体13由与壳体11’相对侧上的擦拭体13’的孔隙率不同的孔隙率制成。
例如,擦拭体13是高孔隙率的半闭孔低密度亲水性聚氨酯医用级泡沫,而相对设置的13’是低孔隙率的半闭孔中密度亲水性聚氨酯医用级泡沫。高孔隙率擦拭体13将首先被使用,如同粗粒砂纸一般,用以除去累积的多个生物膜层的“大块”,而低孔隙率擦拭体13被随后使用,如同细粒砂纸一般,用以除去任何剩余的生物膜。
再有,擦拭体13可以包含不同于另一个擦拭体13’的消毒剂浓度。例如,擦拭体13可以具有较之于另一个擦拭体13’更高的葡萄糖酸氯己定浓度。
当被放置以使用时,在擦洗刷10’一侧上的盖体20被移除以露出擦拭体13。接着,擦洗刷10’以同心方式、以上述关于图3所描述的方式被放置在阴式鲁尔接口的外表面之上。在擦洗刷10’在阴式鲁尔接口上的几次旋转(例如6到9次旋转)之后,擦洗刷10’从鲁尔接口被移除,并且可移除的盖体20’被移除以露出第二擦拭体13’。接着,再按照图3所说明的,这个擦拭体13’被放置在阴式鲁尔接口之上,并且为了除去阴式鲁尔接口上任何剩余的生物膜层,使擦拭体13’旋转类似数目的次数,例如6到8次。
通过使用具有较高粗糙度的擦拭体,几个生物膜层可以从阴式鲁尔接口被除去。随后,较不粗糙的擦拭体用于除去任何剩余的生物膜层或多个生物膜层。在这个方面,如果仅一个擦拭体被使用,会有这样的风险,即刮下的生物膜将使所述的一个擦拭体变得饱和,并且所述的一个擦拭体将不会从阴式鲁尔接口除去所有的生物膜层。第二擦拭体的使用降低这个风险。
因此,本发明提供从阴式鲁尔接口以及类似的导管除去生物膜的方法。
再有,本发明提供降低源自生物膜形成的与导管有关的血行感染风险的方法。
本发明还提供在进入之前能够消毒任何类型的接入系统的表面的方法。
Claims (4)
1.一种微生物擦洗刷,包括:
壳体,所述壳体在所述壳体的一侧上限定第一腔并且在其相对侧上限定第二腔;
设置在所述第一腔中的泡沫材料的第一擦拭体;
设置在所述第二腔中的泡沫材料的第二擦拭体;
在每个所述擦拭体中的抗菌消毒剂;
第一盖体,所述第一盖体可移除地安装在所述壳体上,用以密封所述第一腔和所述第一腔中的所述第一擦拭体;以及
第二盖体,所述第二盖体可移除地安装在所述壳体上,用以密封所述第二腔和所述第二腔中的所述第二擦拭体,
其中所述第一擦拭体包括用以包围阴式鲁尔接口的外表面的环形部分和用以插入所述阴式鲁尔接口的中央通道、在所述环形部分内与所述环形部分同中心的中央部分,并且所述第二擦拭体包括用以包围阴式鲁尔接口的外表面的环形部分和用以插入所述阴式鲁尔接口的中央通道、在所述环形部分内与所述环形部分同中心的中央部分,其中,所述第一擦拭体和所述第二擦拭体各自的环形部分和中央部分纵向共同延伸相同长度。
2.如权利要求1所述的微生物擦洗刷,其中所述第一擦拭体是高孔隙率的半闭孔低密度亲水性聚氨酯医用级泡沫,并且所述第二擦拭体是低孔隙率的半闭孔中密度亲水性聚氨酯医用级泡沫。
3.如权利要求1所述的微生物擦洗刷,其中所述抗菌消毒剂是包含从2%到5%葡萄糖酸氯己定的水溶液。
4.如权利要求3所述的微生物擦洗刷,其中在所述第一擦拭体中的所述抗菌消毒剂较之于在所述第二擦拭体中的所述抗菌消毒剂具有更高浓度的葡萄糖酸氯己定。
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Also Published As
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CN102083555B (zh) | 2015-11-25 |
WO2009123709A2 (en) | 2009-10-08 |
BRPI0909455A2 (pt) | 2015-12-22 |
CN102083555A (zh) | 2011-06-01 |
CN105268701A (zh) | 2016-01-27 |
US8696820B2 (en) | 2014-04-15 |
WO2009123709A3 (en) | 2009-12-30 |
EP2268422A4 (en) | 2014-04-09 |
EP2268422A2 (en) | 2011-01-05 |
US20090241991A1 (en) | 2009-10-01 |
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