CN107036852A - 呼气测试装置 - Google Patents
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Abstract
本发明提供了一种呼气测试装置,其具有吹嘴、收集室、和排出斜槽。呼气样本被俘获在收集室内并通过样本转移组件穿过排出斜槽而被转移至真空容器。
Description
背景技术
本发明涉及从肺采样空气的领域,以及特别涉及获得个人空气样本的领域,所述个人空气样本包括来自个人的肺泡的肺泡气。
来自个人的肺的空气能够用于许多不同类型的测试,这些测试否则将需要使该个人经受侵入性过程。例如,可对肺泡气进行分析以用于但不限于各种不同疾病的非侵入性诊断,包括与溃疡高发病率相关的胃部感染、酶缺乏症、以及代谢疾病和/或异常的非侵入性诊断。对于任意这些测试来说重要的是获得精确样本的能力,所述精确样本包含对于特定测试必须的、表示真实肺泡气的、足够容积的空气。
在消化系统中主要仅通过碳水化合物(糖、淀粉或植物纤维)的细菌发酵来生成氢气和甲烷,从而这两种气体中的任一种出现在呼出气中,它通常是碳水化合物或碳水化合物片段已经暴露至细菌以允许该发酵发生的信号。Levitt,M.D.的《人体中氢气气体的生成和排泄》(Production and excretion of hydrogen gas in man.New Engl.J.Med 1968;281:122,其通过引用并入本文)。H2和/或CH4的生成将导致这些气体中的一些从它们消化部位被重新吸收到血流中,并且它们将出现在呼出气中。
细菌通常在发生糖的消化和吸收的小肠内不以大规模数量存在。因此,在摄取激惹剂量(challenge dose)(例如,乳糖)时,只有当糖未被消化并因此到达大肠时,肺泡气中氢气水平才将在一至两个小时内(基于肠道传递时间)显著地上升。
呼气-H2测试是简单的非侵入性程序,其容易被患者和工作人员所接受(Metz,G.;Jenkins,D.L.;Peters,T.J,;Newman,A.;Blendis,L.M.的《呼出氢气作为低乳糖酶症的诊断方法》(Breath hydrogen as a diagnostic method for hypolactasia.Lancet.1975;1(7917):1155-7,其通过引用并入本文)),并且根据文献中的多数报告,其具有相比血液测试来说更大的可靠度和可接受性(DiPalma,J.A.;Narvaez,R.M.的《转诊病人中乳糖吸收障碍的预测》(Prediction of lactose malabsorption in referral patients.Dig DisSci.1988;33:303,其通过引用并入本文),以及Davidson,G.P.;Robb,T.A..的《儿童中腹泻疾病管理中的呼气氢气分析的价值:与十二指肠粘膜活检对比》(Value of breathhydrogen analysis in management of diarrheal illness in childhood:Comparisonwith duodenal biopsy.J Ped Gastroenterol Nutr.1985;4:381-7);Fernandes,J.;Vos,C.E.;Douwes,A,C,;Slotema,E.;Degenhart,H.J.的《儿童中作为用于乳糖吸收障碍的参数的呼气氢气排泄》(Respiratory hydrogen excretion as a parameter for lactosemalabsorption in children.Amer J Clin Nutr.1978;31:597-602);Newcomer,A.D.;McGill,D.B.;Thomas,R.J.;Hofmann,A.F.的《用于检测乳糖酶缺乏症的间接方法的前瞻性对比》(Prospective comparison of indirect methods for detecting lactasedeficiency.New Engl J Med.1975;293:1232-6);Douwes,A.C.;Fernandes,J.;DegenhartH.J.的《使用呼出H2测量,改进儿童中乳糖耐受测试的精确度》(Improved accuracy oflactose tolerance test in children,using expired H2 measurement.Arch DisChild.1978;53:939-42);Solomons,N.W.;Garcia-Ibanez,R.;Viteri,F.E.的《成人中乳糖吸收的氢气呼气测试:生理剂量和全牛奶源的应用》(Hydrogen breath test of lactoseabsorption in adults:The application of physiological doses and whole cow′smilk sources.Amer J Clin Nutr.1980;33:545-54);每篇都通过引用并入本文)。
较低剂量的乳糖通常不会引起由被给予血液测试所需的大剂量的吸收障碍者所通常观察到的不舒适和爆发性腹泻。
通过超过300位患者的研究显示了乳糖激惹后的GI症状与排泄的H2的量强烈相关,以及血糖变化和症状严重程度之间的关系较不明显。Jones,D.V.;Latham,M.C.;Kosikowski,F.V.;Woodward,G.的《在乳糖不耐受成人中对降乳糖牛奶的症状反应》(Symptom response to lactosereduced milk in lactose-intolerant adults.Amer JClin Nutr.1976;29(6):633-8,其通过引用并入本文)。
假阳性呼气测试是罕见的,并且在它们发生时,它们通常由错误地进行测试引起——允许受试者在测试之前不久或在测试期间抽烟、睡眠、或吃东西。细菌生长过度(从大肠逆行至小肠内)也会产生假阳性呼气测试,但它通常在升高的禁食呼气-H2水平之后并且该响应是在摄入糖之后不久(20-30分钟内)被观察到。
通过呼气测试的假阴性结果的发生率远低于通过血液测试所观察到的。据报道,假阴性结果为所有乳糖消化障碍者的5-15%。Filali,A.;Ben Hassine,L.;Dhouib,H.;Matri,S.;Ben Ammar,A.;Garoui,H.的《通过70位突尼斯成人人群的氢气呼气测试研究乳糖吸收障碍》(Study of malabsorption of lactose by the hydrogen breath test ina population of 70Tunisian adults.Gastroenterol Clin Biol.1987;11:554-7);Douwes,A.C.;Schaap,C;van der Kleivan Moorsel,J.M.的《在学龄儿童中的氢气呼气测试》(Hydrogen breath test in school children.Arch Dis Child.1985;60:333-7);Rogerro,P.;Offredi,M.L..;Mosca,F.;Perazzani,M.;Mangiaterra,V.;Ghislanzoni,P.;Marenghi,L.;Careddu,P.的《在健康意大利儿童中的乳糖吸收和吸收障碍:吸收不良的糖的量和小肠传递时间是否在症状生成中起作用?》(Lactose absorption andmalabsorption in healthy Italian children:Do the quantity of malabsorbedsugar and the small bowel transit time play roles in symptom production?JPediatr Gastroenterol Nutr.1985(Feb);4(1):82-614);每篇都通过引用并入本文。这是由于各种原因。除氢气之外还通过测量甲烷能够避免许多假阴性报告,这是因为一些产甲烷菌群将大肠的H2转化为CH4。Cloarac,D.;Bornet,F.;Gouilloud,S.;Barry,J.LI.;Salim,B.;Galmiche,J.P.的《在健康受试者中对乳果糖的呼气氢气响应:与甲烷生成状态的关系》(Breath hydrogen response to lactulose in healthy subjects:relationship tomethane producing status.Gut.1990(Mar);31:300-4),其通过引用并入本文。
发明内容
根据本发明,提供了一种测试装置。包括呼气入口通道或吹嘴的呼气收集装置连接至第一单向耦合接头,其优选地、但并非必须地是翼形阀(flutter valve)。呼气被排出到吹嘴内并穿过单向耦合接头。收集室通过所述第一单向耦合接头连接至所述呼气入口通道,以及第二单向耦合接头,其也优选地、但并非必须地是翼形阀,其连接至所述收集室以允许呼出的气息的第一废气部分离开收集室。在呼吸完成时,两个单向耦合接头都将关闭,将呼气末气息样本俘获在收集室内。连接至所述收集室的样本转移组件允许将真空空气室选择性地连接至所述样本转移组件,并且真空空气室回收收集室内呼气末气息样本的一部分。在优选实施方式中,排出斜槽(discharge chute)环绕所述样本转移组件连接至所述收集室,所述排出斜槽包括用于连接至所述收集室的近端,以及用于接收所述真空空气室的远端。
附图说明
图1是本发明的样本收集装置的透视图,其中真空空气室插入到排出斜槽的远端内;
图2是本发明的样本收集装置的分解透视图;
图3是样本收集装置的使用中的侧横截面图,示出了收集呼气样本;
图4是样本收集装置的侧横截面图,其中真空空气室正被插入到排出斜槽的远端内;
图5是样本收集装置的侧横截面图,其中真空空气室正被插入到排出斜槽内的排出针上;
图6示出了收集的呼气末气息样本。
优选实施方式的描述
尽管这里的公开是详细且准确的以使得本领域技术人员能够实施本发明,但这里公开的实际实施方式仅例证了本发明,本发明可以以其他特定结构体现。尽管已经描述了优选实施方式,但在不偏离本发明的情况下可以改变细节。
现在参照图1,示出了本发明的样本收集装置10的透视图。示出了包括呼气入口通道的吹嘴12,以允许呼气传至收集室14。呼气排出斜槽16接收真空空气室100,真空空气室100接收来自收集室14内的呼气末气息样本(稍后描述)。
现在参照图2,示出了本发明的样本收集装置10的分解透视图。吹嘴12被整体形成具有单向排出组件26或与单向排出组件26连接。来自呼吸的正压穿过吹嘴12引起柔性环24弯曲,并允许空气在收集室14的上游末端处进入到收集室14内。柔性环24优选地但并非必须地是翼形阀。再次连接至柔性环24(再次,其优选地但并非必须地是翼形阀)的另一单向排出结构26连接至收集室14的下游末端。连接至收集室14的内部的是排出针22,其提供了收集室14和最终的真空空气室100之间的来自呼吸的选择性通道,真空空气室100通过排出斜槽16连接至排出针22。
现在参照图3,示出了样本收集装置10的使用中的侧横截面图。患者已经将嘴压至吹嘴12并开始呼气。第一呼吸容积42将来自收集室14内的背景空气排出,并且第一呼吸容积42,其对于肺泡气采样来说不是最期望的,被通过排出斜槽16排出而不被获取。来自呼气样本的正压使柔性环24弯曲,允许空气持续地流经收集室14进入到排出斜槽16内。
随着呼吸停止,来自呼吸的正压也停止,使得柔性环24返回至它们的静止位置,在收集室14的上游和下游末端处与单向排出结构26齐平。由于柔性环24密封收集室14,呼气末气息样本40被俘获在收集室14内。为了取回呼气末气息样本40以方便用气相色谱分析仪器采样,期望的是在真空空气室100(测试管)内收集呼气末气息样本40。真空空气室100具有容积V1,其优选地是相比收集室14的容积V2来说的较小容积,从而使得真空空气室100仅从收集室14收集呼气末气息样本40,而不收集通过收集室14吸入的外部空气。
真空空气室100如图4中所示的插入到排出斜槽16的远端内,以及如图5中所示,真空空气室100插入到排出针22上,排出针22刺穿空气室100的隔膜20(优选为自密封的)。真空空气室100然后从收集室14取回呼气末气息样本40。在空气室100已经从收集室14取回呼气末气息样本40后,可以将空气室100从排出斜槽16内的排出针22撤回。包含呼气末气息样本40的空气室100然后能够在实验室中根据需要针对目标分析物进行处理。
前述理解为仅示意本发明的原理。此外,由于许多修改和改变对于本领域技术人员来说将是容易想到的,不期望的是将本发明限制到所示出和所描述的确切构造和操作。尽管已经描述了优选实施方式,但在不偏离本发明的情况下可以改变细节。
Claims (5)
1.一种呼气收集装置,其包括:
呼气入口通道;
第一单向耦合接头;
收集室,其通过所述第一单向耦合接头连接至所述呼气入口通道;
第二单向耦合接头,其连接至所述收集室;以及
样本转移组件,其连接至所述收集室。
2.根据权利要求1所述的呼气收集装置,该装置还包括真空空气室,其选择性连接至所述样本转移组件。
3.根据权利要求2所述的呼气收集装置,该装置还包括排出斜槽,其环绕所述样本转移组件连接至所述收集室,所述排出斜槽包括用于连接至所述收集室的近端,以及用于接收所述真空空气室的远端。
4.根据权利要求1所述的呼气收集装置,该装置还包括排出斜槽,其环绕所述样本转移组件连接至所述收集室。
5.根据权利要求1所述的呼气收集装置,其中所述单向耦合接头中的至少一个包括翼形阀。
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US20170215764A1 (en) | 2017-08-03 |
US10413216B2 (en) | 2019-09-17 |
EP3202321A1 (en) | 2017-08-09 |
CN107036852B (zh) | 2022-03-08 |
CA2944099A1 (en) | 2017-08-03 |
EP3202321B1 (en) | 2019-12-11 |
AU2016231652A1 (en) | 2017-08-17 |
AU2016231652B2 (en) | 2021-09-16 |
USD917691S1 (en) | 2021-04-27 |
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