CN103393534B - 用于鼻冲洗的系统和方法 - Google Patents
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Abstract
提供了用于鼻冲洗的系统和方法,其中鼻冲洗装置包括盐溶液源、流出物接受器、鼻接口、真空源、通过鼻接口和使用者的鼻腔使盐溶液源与流出物接受器相通的流体通路以及用于选择性地控制真空源和通过流体通路的盐溶液流的开关和阀组件。盐溶液源瓶相对于装置放置,以提供重力诱导而使盐溶液进入与装置使用者的鼻孔接合的鼻接口。重力诱导和来自流出物接受器的相对真空的组合产生流体流,以冲洗、清洗和按摩使用者的鼻腔和小孔。
Description
本申请是申请日为2008年3月6日,申请号为200880014072.4,发明名称为“用于鼻冲洗的系统和方法”的申请的分案申请。
技术领域
本公开实施方案一般涉及用于冲洗和清洗鼻腔以及至鼻腔的解剖开口(anatomical opening)的方法和装置。
背景
鼻和鼻窦疾病,以及与鼻窦相关的综合症和症状是常见的临床问题,其具有相当高的患者发病率、大量的直接费用和对受其折磨的人生活质量的显著的消极影响。受折磨的人群的四个主要类别是:1)患有急性和慢性鼻窦炎的人;2)患有急性上呼吸道感染的人;3)遭受过敏性鼻炎之苦的人;以及4)有慢性鼻鼾问题的人。这四个类别相当于每天数百万遭受鼻塞之苦的人。
疾病控制和预防中心估计1994年美国的慢性鼻窦炎病例数量为3500万,而患病率约为13.5%,或根据2007年人口数据调整后约为4050万美国人。鼻窦炎是第五个最常见的诊断,其在1985至1992年间被给予抗生素治疗。在1996年,鼻炎占了约2670万例诊所和急诊科的就诊,导致了58亿美元的直接费用。
据报道,过敏性鼻炎影响美国约17%的普通人群,且在所选的儿童群体中,可能以高达42%的比例出现。这相当于6000万美国人的估计值上限。
打鼾目前影响约9000万美国成年人,其中3700万是经常地。
受鼻窦炎、过敏性鼻炎和打鼾之苦的人数总和达到的高估值为1.9亿美国人,且低估值为1.28亿美国人,其中不考虑可能被划分在两个或更多类别中的重复计算的个人。采用超过40%重复的保守假设,得到估计值为7500万美国人,这些人遭受有害的鼻窦症状之苦,并将能受益于缓解那些症状的有效疗法。
为了改善空气流并缓解鼻塞,用淡盐水浸泡鼻腔和鼻窦腔以洗去形成硬壳的黏液、刺激物和外来颗粒,这一方法在很多文化中广泛实践了差不多几千年。最近,且特别是从约1990年以来,美国和欧洲一流的医学院及研究中心进行了相当数量的同行评审的临床试验,以测试关于由鼻冲洗所致的鼻疾病症状缓解的无对照的主张是否有充分根据并通过科学审查。
一些临床研究证明,经常使用鼻冲洗是有效的缓解慢性和急性鼻窦炎症状的疗法,包括统计上显著的发现例如鼻塞的减少、鼻道气流的增加、看医生次数的减少、鼻窦药品处方数量的减少和生活质量的改善。其他临床研究表明,经常的鼻冲洗是治疗与过敏相关的鼻症状的有益疗法。其他如尚未发表的临床研究目前正在进行中,以测试鼻冲洗是不是关于普通感冒和打鼾的有效预防疗法。
这些研究表明,鼻冲洗是用于通过将鼻腔暴露在大量的流动盐水中来治疗鼻窦相关疾病症状的临床验证方法。虽然实现鼻冲洗效果的确切机制尚未完全被医学和科学研究界所理解,但它很可能是多面性的并且包括如下的许多生理效应,其中所述生理效应可单独地或一起引起鼻粘膜能力的提高,以减少炎症介质的病理效应以及过敏性鼻炎、哮喘和其他慢性粘膜反应的其他诱发因素。第一,它冲洗鼻腔的整个内部,洗掉可能阻断连接鼻窦腔和鼻腔的多个小孔的硬壳,从而允许鼻窦腔恰当地向鼻腔内排液并使鼻窦腔变成较不吸引细菌集群的滋生地。第二,它减少鼻腔内粘液的粘性,从而极大地减少内部硬壳的形成。第三,它在鼻腔内部表面留下少量的盐水残留,包括通向鼻窦腔的开口以及有时候在鼻窦腔本身内。这是有益的,因为盐水具有内在的阻碍细菌生长的抗菌性质。第四,在空气到达肺之前,将加温和润湿由鼻吸入的空气的鼻甲骨和血管组织暴露在盐水中导致它们尺寸缩小,从而减少鼻塞。第五,它改善粘膜纤毛清除功能,因为增加的纤毛摆动频率提高了粘膜进行其天然的刷洗功能的能力。第六,盐水可以洗去导致感染和过敏的空气传播的细菌、病毒颗粒、刺激物和其他外来颗粒。
有三种冲洗鼻腔的方法:重力、压力和吸力。
基于重力的装置通过例如将茶壶状喷管的尖端插入一个鼻孔并将盐水注入其中而允许盐水流进鼻腔。盐水然后绕鼻中隔的后缘流动并从使用者另一个鼻孔流出。基于重力的装置的实例是涅涕壶(neti pot)。然而,完成这样的冲洗所必需的尴尬的身体位置对于许多人都有难度,而且来自鼻通道的自由流动的流出物是肮脏的,以至于大量的清理步骤是必要的。
基于压力的装置将盐水用泵送入鼻腔,再一次地,通过将盐水引入一个鼻孔,用压力迫使它绕过鼻中隔的后缘并允许它从另一个鼻孔流出。这可以通过例如以下步骤完成:将充满盐水的柔韧的塑料管或瓶子的喷嘴放入一个鼻孔并挤压它,从而将盐水注入一个鼻孔,经过鼻腔并且从另一个鼻孔流出。虽然这避免了为实现重力迫使的流动所需的一些身体尴尬,但是肮脏的问题和护理员清理的不方便仍然存在。此外,通过挤压所给予的各种各样的压力可能带给遍及鼻通道且特别是咽鼓管孔的不期望的、疼痛的和甚至有害的压力。因此,这需要获得一些技巧以适当地使用。
现有装置一般都没有利用吸力。使用吸力进行鼻冲洗的最常见方法和使用者用其手掌捧少量的淡盐水并将水吸入其鼻孔一样简单。
目前没有为使用者提供在一台装置上使用所有三种输送方法进行鼻冲洗的能力的实用装置。
目前没有为使用者提供在一台装置上使用重力和压力、重力和吸力或压力和吸力的组合进行鼻冲洗的能力的实用装置,也没有为上述三种组合中任一种提供驱动机构(powered mechanism)的装置。
目前没有为使用者提供单独使用吸力进行鼻冲洗的能力的实用装置。
对方便的手持装置的需求是存在的,所述装置可以安全地用受控的平缓供给冲洗鼻腔,在平缓的驱动吸力影响下将冲洗剂(irrigant)吸引穿过鼻腔,以利于迅速和简单处置的方式安全收集流出物,并且可容易适用于多种鼻尺寸。
概述
提供了一种对使用者的鼻腔进行治疗性冲洗的鼻冲洗装置。所述装置包括盐溶液源、流出物接受器(effluent receptacle)、鼻接口(nasal interface)、真空源、流体通路以及开关和阀组件。鼻接口与装置使用者的鼻孔接合以通过重力将盐溶液从源输送至鼻腔。盐溶液源通过流体通路、鼻接口和装置使用者的鼻腔与流出物接受器相通。开关和阀组件控制真空源和经由流体通路的盐溶液流。应理解,除了前面提到的盐溶液外,可选择的冲洗剂也可纳入所述装置的使用。
本发明提供了一种鼻冲洗装置,包括:
冲洗剂源;
流出物接受器;
鼻接口,其用于将冲洗剂输送至装置使用者的鼻孔,鼻孔相对于所述冲洗剂源放置,以将冲洗剂重力诱导到所述鼻接口;
真空源,其用于在所述流出物接受器中形成相对真空;
流体通路,其通过所述鼻接口和使用者的鼻腔使所述冲洗剂源与所述流出物接受器相通;以及
开关和阀组件,其用于选择性地控制所述真空源和冲洗剂通过所述流体通路的流动。
所述真空源是电动机和泵组件。
所述冲洗剂源和所述流出物接受器可选择性地从所述装置拆分。
所述鼻接口包括设置成与鼻孔密封接合的第一喷嘴和第二喷嘴。
所述鼻接口根据使用者的解剖学是可调节的。
所述冲洗剂源设置于所述鼻接口的上方,以便朝鼻孔重力诱导冲洗剂。
所述流出物接受器设置于所述鼻接口的下方。
所述装置还包括与所述冲洗剂源和所述流出物接受器相关联的压力释放阀。
所述冲洗剂包括盐溶液或其混合物,包括桉树、春黄菊、薄荷或药物,其中所述药物包括抗生素、类固醇或镇痛剂。
还提供了一种用于冲洗鼻腔的方法,其包括将使用者的鼻孔密封到手持装置,其中手持装置包括与盐溶液源和盐流出物接受器相通的相关的流体通路。通路、源和接受器整体地组装在手持装置中。使用也包含在手持装置中的驱动吸力源(powered suction source)将相对真空施加到流出物接受器。将盐溶液从源释放到通路和鼻腔内,借此,穿过鼻孔并绕过使用者的鼻中隔的后缘的盐水流冲洗鼻腔。
附图简述
图1是本发明的鼻冲洗装置的实施方案的透视图;
图2是图1实施方案的侧视图;
图3是显示了去掉顶壁以更清晰观察图1实施方案的组件的被封装元件的剖面透视图;
图4是图2侧视图的局部截面图,其中外侧壁被去掉,以再次显示内部元件;
图5是对应于图3的装置的顶部平面图,其中顶壁也被去掉以同样地说明内部组件;
图6是装置内部部件的局部视图,其中所有外壁都被去掉;
图7是可选实施方案的类似于图6的视图,其中缺少真空源,例如电泵组件;
图8是另一个可选实施方案的透视图,其中手柄被放置在鼻接口的下方、流出物接受器的前方;
图9是另一个可选的实施方案,其中盐溶液源和流出物接受器都被相对地放置在鼻接口的下方;
图10是再一个可选的实施方案的透视图,包括类似于杯子并含有侧手柄的构造;
图11是图10实施方案的侧视图,特别地展示了图10中不明显的背视图;
图12是图11实施方案的局部截面图,特别地展示了内部部件;以及
图13是展示实践鼻冲洗方法的实施方案的步骤的流程图。
简述
附图显示了鼻冲洗装置或工具,优选地容易手持使用,其能为鼻腔和鼻窦孔提供更方便的、更干净的、更舒适的和更有效的冲洗疗法。装置10主要包括三个部件:含有例如盐溶液的冲洗剂源瓶12、用来接收盐流出物的接受器瓶14和用于控制流体从第一个瓶经过鼻腔并进入第二个瓶的相通的控制器16,这在下文将更充分地解释。瓶12、14可以是各种形状中的任一种,并可按任何种类的方式连接到控制器,例如以螺纹颈、过盈配合、卡口固定件及类似方式。通常的尺寸将容纳6盎司至10盎司的流体。设想,第一个瓶12在由于使用而被清空后可以接着用作第二个瓶14,其中瓶14在使用中被流出物充满后可随即被丢弃。因此,提供的单个瓶可以在第一次作为装盐水源的第一个瓶,而然后在下一次作为流出物接受器14。还在本实施方案所期望的范围内,瓶可以是可重复填充的或可重复使用的,或者甚至可以是控制器16中固定的腔,所述腔可以在完成冲洗疗法时被充满或清空。在图3中,瓶12’缺少顶壁,因此它是开口式的以便于重新装满。虽然在此提到盐溶液作为示例性的冲洗剂,但是本实施方案旨在包括含有食用香料或药物的各种盐混合物的可选冲洗剂。
控制器16包括手柄部分20和外壳22。手柄20旨在起到手枪式把手的作用,包括触发器24和轴架底座26,轴架底座26具有平的底部壁28以允许整个组件10在不使用时竖立于平整表面如浴室梳妆台或厨房台面上。底座26还包括弓形切口30,弓形切口30成形为以有利于相对于控制器16支撑和定位瓶14的方式匹配流出物瓶14的轮廓。手柄组件20被配置成适合于右手或左手抓握,因为触发器24和手柄的人体工学配置旨在不区分左右手(handed-neutral)。外壳22包括顶壁34,顶壁34包括源瓶开口36和鼻接口38,盐源瓶延伸通过开口36,鼻接口38布置成以良好的密封衔接使用者鼻子的鼻孔32,以便通过使用者的鼻腔在源瓶12和流出物瓶14之间形成完整的流体通路。鼻接口包括第一和第二喷嘴40、42,其也被称作鼻垫,并可以旋转或枢轴转动,因为可能会需要与鼻孔形成垫密封,这取决于使用者个人的解剖学。鼻垫和使用者鼻孔之间的正压密封对于成功操作装置以实现其治疗功能并区别方便、清洁和整洁的特性是必要的。因此,垫40、42被特别地配置成利于这样的密封。在操作中,只要接口38和鼻孔之间的衔接密封得到保持,从鼻腔的渗漏就被避免。可以看到,鼻垫在平面视图上具有被截的椭圆构型,而在截面上具有略微扁平的圆锥形构型。垫开口稍微地远离垫的中部间隔开,以提供更广泛的密封表面,为的是衔接鼻孔的外边缘而不是由鼻中柱界定的内边缘。垫40、42可以可选择地包括公用喷嘴,其可容易地移除和替换以方便清洗或连接对应于不同人使用者的私人喷嘴套装。通过转动支撑旋转齿轮56或其他通常了解的机械方法进行调节以适应不同鼻子尺寸。
鼻接口的整体构型旨在通过将喷嘴40、42平缓但稳固地推向使用者的鼻孔32而实现正压的、不漏液的密封。
具体参照图3-6,可以看到,外壳还包括用来支撑形成流体通路的流体导管的下部外壳壁44和用于将盐水从第一个瓶12导入第二个瓶14的泵组件60。第一个瓶安装到控制器16,使得盐水可相通到盐水供给导管46和供给瓶压力缓解导管48(图6)。供给导管穿过触发器24,触发器24可卷曲导管或以其他方式例如使用阀(未显示)停止通过导管的流体流。导管46通常通过卷曲而被闭合,并且只在使用者激活触发器24时才从瓶向鼻接口传递流体。供给导管46直接与第一个喷嘴40相通,以使盐水可被导入使用者左鼻孔(如所示),穿过鼻腔,并且然后接收在第二个喷嘴42中,以便通过流出物导管50直接通入流出物瓶14。流出物瓶14安装到流出物瓶固定架52。导管的尺寸和配置不被特别地限制,除非允许现成的流体流。3/16至5/16英寸的大小被证明是可操作的。将导管折角末端的尖锐度尽量减小以及恰当的体积度量能实现期望的冲洗疗法。流出物导管50在流出物瓶固定架52终止,固定架52在流出物瓶14、导管50和真空源导管54之间提供不透气且不漏液的密封。
本实施方案的特征的是,真空泵组件60是装置10内的相对真空源,以便除了对来自源瓶12的流进行重力诱导之外还通过吸力吸引盐水冲洗剂通过鼻腔以增强流动而更好地协助冲洗疗法。相信,真空源是关于使用者健康和治疗经验的提高的敦促力,这与将盐水压入腔内并在其中产生高压区的基于压力的泵装置相反。因此,真空泵60通过真空导管54将相对真空或负压通入流出物瓶,从而促进将盐水吸引通过鼻腔并从第二个鼻垫42排出。压力缓解阀64布置成使得限制真空的最大值为不超过约5.5英寸汞柱。压力缓解阀62类似地允许用空气替代流出供给瓶12的盐水。
通过位于手柄基座26内的电池源68将电力提供给泵60。电池源可包括可替换或可充电的电池,或可以可选择地包括用于冲洗装置的有线电源,冲洗装置可在专业的医疗环境中被不间断地使用。
具体参照图4,触发器24的操作不仅释放盐水流使之流过供给导管46,而且还在被拉到闭合时接合开关70,以便由电池供给68向泵60提供电能。
在操作中,通过手持或如果被支撑在表面上则通过将使用者的头移向期望的衔接位置,按照图2所示的方式将装置10放置在鼻孔附近。使用者拉动触发器24使之同时地引起几个结果。可以看到,第一个瓶12相对地放置到鼻腔以使盐水在鼻腔上方。盐水供给导管46的开口允许盐水流体简单地在重力作用下流到第一个喷嘴,且类似地全部在重力作用下在余下的流体通路中穿过鼻腔。单独使用重力事实上是一个特殊的实施方案,如下将讨论的。然而,通过动力驱使的吸力吸引流体穿过鼻腔显著地增强对有效鼻冲洗重要的元件的冲洗、按摩和漂洗。此外,动力驱使的吸力的使用实际上消除了将疼痛的和有潜在害处的压力应用到鼻腔中的咽鼓管孔的风险。因为流全都是向下走的,所以需要相对小量的真空就能达到期望的效果,即吸引盐水绕鼻中隔的后缘并从流出物鼻孔流出。能够产生3至5PSI范围的真空的微型泵足以达到充分地给流出物瓶降压的目的。然而,可选的实施方案(图12)可容易地包括多速泵源,以用于基于不同触发器位置改变压力。
具体参照图7,显示了流体通路82的可选实施方案,其中缺少泵组件60和电池组68。盐水将通过供给导管46穿过鼻腔并进入流出物导管50,以便仅在重力诱导下流入流出物接受器,这是因为鼻接口38和流出物接受器14(未显示)都被放置在供给瓶12的下方。虽然流缺少图1实施方案中动力驱使的增强的流冲洗作用,但是图7实施方案仍提供鼻腔的治疗性冲洗。在这个实施方案中,缓解阀64、62作为通气口的作用将多于作为压力调节器的作用。
具体参照图8,显示了可选的实施方案90,其中手柄92直接放置于鼻接口94的下方和接受器瓶14的前方,并包含拇指开关95,开关95的操作释放盐水流,并为泵供给电能。虽然这个实施方案90中包括流体通路的内部导管稍微不同以适应瓶14的可选择的定位,但有效的操作是相同的,且提供不需要像如图1实施方案那样绕过瓶14抓握手柄20的优点。
具体参照图9,显示了再一个可选的实施方案,除了供给瓶12”现在被放置在外壳98的下方并挨着流出物接受器瓶14”之外,其类似于图8的实施方案。在这个实施方案中,因为供给瓶12”被放置在接口100的下方,所以仅仅重力不能将盐溶液从瓶12”引入接口100。因此,瓶12”必须以某种方式加压以驱使盐溶液通过供给导管102。在这种情况下,泵组件(未显示)通过压力导管104将空气泵入瓶12”中,这以与将空气泵出流出物接受器瓶14”以获得其中期望的相对真空相反的方式进行。可选择地,泵组件可包括用于实现为供给瓶12”加压的第一个泵(未显示)和以类似于泵60的方式在流出物接受器14”中引起相对真空的第二个泵(未显示)。
具体参照图10-12,显示了可选的实施方案,其具有更像杯子状的构造72,包括侧手柄74和拇指控制的触发器76(鼻接口未显示)。供给瓶78接纳在支撑固定架80上,而流出物瓶81具有可拆卸的腔82。触发器76控制双速开关77以改变流速。
具体参照图13,详述了用于实践鼻冲洗的方法。所述方法包括将使用者的鼻孔密封到装置10的包括供给和流出导管的流体通路。当使用者通过拉动触发器24打开装置时,在108将相对真空施加到流出物接受器14上,同时从供给瓶12释放盐水以将流引至鼻接口38并进入鼻腔,且特别地绕过鼻中隔的后缘并最终进入流出物瓶。流通过由于将供给瓶12置于接口38和接受器瓶14的上方产生的重力和通过流出物瓶14中的相对真空所致的吸力而被诱发。
液体供给应至少包括组成为避免刺激鼻腔的盐溶液。已经发现,包括各种香味或味道的混合物可改善体验,例如桉树、春黄菊(chamomile)、薄荷及类似物。也已经发现,用碳酸氢钠缓冲溶液可改善体验。也已经发现,使用高渗盐水可改善体验。也可使用可选择的冲洗剂以及药物混合物诸如抗生素、类固醇或镇痛剂,药物混合物特别适合于冲洗时的鼻腔输送,这一点与吸收剂相反。
Claims (12)
1.一种手持鼻冲洗装置,包括:
盐溶液源;
流出物接受器;
鼻接口,所述鼻接口包括设置成与装置使用者的鼻孔密封接合的第一喷嘴和第二喷嘴,其中所述鼻接口和所述流出物接受器设置于所述盐溶液源的下方;
真空源,其用于在所述流出物接受器中形成相对真空;
流体通路,所述流体通路设置成从所述第一喷嘴到所述第二喷嘴通过使用者的鼻腔使所述盐溶液源与所述流出物接受器相通;以及
控制器,其包括开关和阀组件,所述开关和阀组件用于选择性地控制所述相对真空,并且其中所述鼻接口、所述真空源和所述流体通路均包括在所述控制器内。
2.根据权利要求1所述的装置,其中,所述真空源是电动机和泵组件。
3.根据权利要求2所述的装置,其中,所述电动机和泵组件是电池供电的。
4.根据权利要求3所述的装置,包括用于给所述电动机和泵组件供电的可充电的电池。
5.根据权利要求2所述的装置,其中,所述电动机和泵组件是有线插座电源供电的。
6.根据权利要求1所述的装置,其中,所述盐溶液源和所述流出物接受器选择性地从所述装置可拆分。
7.根据权利要求1所述的装置,其中,所述鼻接口选择性地可移除。
8.根据权利要求7所述的装置,其中,所述第一喷嘴和所述第二喷嘴的位置是根据使用者的鼻子尺寸可调节的。
9.根据权利要求1所述的装置,其中,所述流出物接受器设置于所述鼻接口的下方。
10.根据权利要求1所述的装置,还包括用于控制所述盐溶液到所述流体通路的供给的阀。
11.根据权利要求10所述的装置,其中,所述装置还包括真空导管,所述真空源是真空泵,且所述真空导管设置成在由所述开关启动所述真空泵时将所述相对真空通入所述流出物接受器。
12.根据权利要求1所述的装置,还包括手柄,所述手柄放置于所述鼻接口的下方和所述流出物接受器的前方且包括在所述手柄中的用于所述开关的触发器。
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CN2008800140724A CN101674790B (zh) | 2007-03-06 | 2008-03-06 | 用于鼻冲洗的系统和方法 |
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US1502163A (en) * | 1922-12-19 | 1924-07-22 | William P Sprague | Nasal douche |
US2078180A (en) * | 1933-10-24 | 1937-04-20 | Kronenberg Isaac Bert | Medical apparatus |
US5899878A (en) * | 1998-06-24 | 1999-05-04 | Bradley Pharmaceuticals, Inc. | Nasal irrigation system |
CN2383512Y (zh) * | 1999-07-16 | 2000-06-21 | 吴秋木 | 一种洗鼻器 |
CN2402324Y (zh) * | 2000-01-15 | 2000-10-25 | 李长清 | 鼻腔冲洗器 |
US6907879B2 (en) * | 2002-02-04 | 2005-06-21 | Ndt | Agent delivery and aspiration device |
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