CN1033056C - 一种血样采集方法及其所用的组件 - Google Patents
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Abstract
从真空玻璃或透明塑料管中离心分离的多成分物质中采集成分层,该管中包含一个浮子。当可能受到污染的物质,如血液,受到检测时,使用一种真空的管子允许技术人员不接触血液的情况下进行检验。该管子足以容纳大约一毫升的血液,并且充以低压惰性气体。该浮子上开有一个通孔,在离心分离过程中所要采集的血球带便沉积其中。血球带被一层可流动的物质所稳定,要采集的血球层用一个***管子及浮子孔中的注射用针或套管从浮子孔中抽出。
Description
本发明涉及判定诸如血这样的物质的离心样本中有关成分层的信息的设备与方法。该成分层是从一个包含一个浮子的真空管中采集的,该浮子使被采集的成分层扩张,并包含一个通孔或通道使特定的成分层在离心中沉淀在其中。在含有一个浮子的毛细管或其它管中离心分离物质混合物的样本以测定该复合物质混合物的成分层的技术已经研制过。该浮子最好是圆柱形的并具有这样的比重使之能下沉到被离心分离的混合物中到一定程度以在管子内建立一个环状自由空间,要测定的一层或多层便沉淀在其中。从而要测定的层得以物理地伸长,并能够更容易与更精确地加以测定。这一技术公开在1977年6月7日发布的美国专利4,027,660,1978年4月4日发布的美国专利4,082,085以及1979年5月29日发布的美国专利4,156,570等中。
当被测物质是血这样的可能受污染的物质时,希望采取措施以防止技术人员与血样接触。当使用毛细管来执行上述先有技术时,由于毛细管是开口的,执行检验的人员便暴露在血样前。因此,在操作样本时尽管采取了正常的预防措施,然而被污染的机会仍然存在。上述先有技术也不能轻易地从管中采集离心分离的血球带中的任何一种。
本发明旨在提出一种用于从诸如血这样的可能被污染的物质中采集成分血球或其它颗粒的一种方法与设备,其中进行采集工作的人员永不与血样接触。从而,消除了受污染的血样感染的可能性。当采用本发明的管子与浮子时,血样被采集在一个密封的管中;然后在该管中浓集要采集的血球;并且这些血球可从管中抽出而使技术人员永不接触血样。本发明的附加优点在于这样的事实,它只需使用一个单一的密封管来装在血球浓集与采集中所用的全部所需成分,并且这些成分是放置在一种稳定的隋性环境中的。本发明中所使用的管子最好是带有一个整体的密封端的玻璃管。它与一个毛细管等长但具有较大的直径以容纳大约0.9毫升的血。在管中放置一个圆柱形浮子,该浮子具有精确地控制的外径使之能在稳定的状态下可以紧贴地与管孔配合。当用于采集血球时,该浮子上有一轴向通孔用于接纳并扩张离心分离后的血样中的白血球与血小板层。该浮于是用一种具有特定比重的塑料制成的使之当管中的血样离心分离后浮在密集的红血球中。所需的试剂,诸如染色剂与红血球浓缩剂,最好是草酸钾,可放在管中,最好是以液态。管子的开口端用一个弹性的塞子封闭,管子内部充以低压隋性气体,管内的低压用于将血样吸入管中,最好是从一个原始血液采集器中吸入,诸如Becton Dickinson(贝克顿狄金生)公司出售的商标为“Vacutainer”的那种。
该浮子最好是一种用塑料制成的复合结构,具有能使它浮在离心分离后的红血球层上的比重。浮子以具有所述通孔的一个核心部分以及一个环形套筒部分构成,后者在样本的离心分离过程中能够按照作用在浮子上的动态力的大小膨胀与收缩。浮子的核心部分必须用一种塑料物质例如透明的苯乙烯制成,它的尺寸在离心期间是稳定的。浮子的周边套筒部分可用一种透明的柔软的乙烯树脂塑料制成。浮子的两个部件可用共同冲压或共同模铸该两个浮子部件来结合成一体。在管子上可设有润滑涂层,诸如硅酮来增进在离心分离时浮子在管内的运动。可用于浮子的核心与外套的特定塑料分别是聚苯乙烯及聚氯乙烯(PVC)。必要时浮子也可由一种单一的材料制成。
原始血液采集管设有一根针,用于刺穿本发明的管子中的弹性塞子,这时血液将从该采集管流经该针而进入试管。为了在管子与血液离心时保持管中的血球带形成,在管子的顶部放入一种摇溶的凝胶。在离心分离中,该凝胶将沿管壁流下沉积在血浆层的顶部在血浆上形成一个粘性薄膜,明显地,凝胶必须具有比血浆小的比重。一个薄塑料帽可用来代替凝胶。
当较大管径的管子及较大的具有轴向孔的浮子用于本发明时,管腔内径的直径大小容差得以缓和。在使用上述先有技术的管子浮子组合来进行血球采集时,希望能使白血球与血小板层扩张十倍。当使用本发明的扩大了的管子与浮子时,在使用4.0毫米直径的管腔时,十倍的扩张可以从具有1.26毫米直径的一个通孔中获得。这相当于使用先有技术毛细管与浮子时大约43微米的自由空间。当采用本发明的设备时孔直径的正负公差为20微米。
从使用较大的管子与浮子设备中得到的一种好处是离心分离的流体动力学的改进。血液加入管中以后,通常用10,000G(重力加速度)对管子离心转动。当使用这一种浮子时,若干个力产生作用。首先,向心加速度在血球分离的同时迫使浮子向管子的一端运动。其次,由于在浮子的两端加速度是不相等的,在浮子上便作用有一个潮汐样的力。这一潮汐样力在靠近管子中段处大约为2,000G。这在浮子上作用一个大约为500G的拉伸或压缩力,这便足以使浮子的柔软的弹性部分充分地伸长并稍为减小其直径,使它能够容易地在管子中滑下。当浮子根据其密度沉入红血球层中并且离心机减慢到停止时,该潮汐样力终止,从而浮子放松到其正常直径,从而恢复其与管壁之间的紧密接近。
血球与血沉棕黄层的成分便在浮子的狭孔通道中线性地扩张,并且从而可以从那里容易地采集。
因此,本发明的一个目的是提供一种改进的血液采样设备,它允许技术人员不接触血样的污染而进行血球采集。
本发明的另一个目的是提供具有所述特性的血液采样设备,它在提供必要的血球层扩张的同时可以缓和对尺寸容差的要求。
本发明的一个附加的目的是提供具有所述特性的血液采样设备,它使用较大的血样。
本发明的又一个目的是提供具有所述特性的血液采样设备,其中离心分离后的血球带的形成是稳定的并且是保持原样的。
本发明的又另一个目的是提供具有所述特性的血液采样设备,它在离心中可以达到改进的流体动力学特性。
本发明的这些与其它目的与优点将通过下面结构附图考虑的对其较佳实旋例的说明得到更清楚的了解,其中:
图1为按照本发明构成的管子与浮子组件的一个较佳实施例的轴向剖视图。
图2为浮子的轴向剖视图。
图3为展示该组件用于从一个原始血液采集管中抽取血样的轴向剖视图。
图4为类似于图1与图3的视图但所展示的为血样已经抽取并离心分离后的图1的组件。
图5为展示从离心分离后的样本中采集一个血球层的局部剖视图。
现在参见附图,在图1中示出的为按照本发明构成的血液采样设备的一个较佳实施例。该血液采样设备包括一个透明管子2,它最好由玻璃制成,并具有一个整体的闭端4。一个塑料浮子部件6放置在管子2中,同样放在管中的还有染色剂及红血球浓缩剂8。一个弹性塞子10封闭管子2的开口端,并且在管子2内部围绕塞子10放置有摇溶性凝胶12。也可用于个薄的塑料片或帽17一代替凝胶12。该管子最好大约为75毫米长,与一个毛细管的长度相同,并具有直径大约为4.0毫米的管腔。其血液容量大约为0.9毫升。当该浮子静止在管中时,其长度大约为8毫米而直径大约为4毫米。
浮子6是一种复合结构,它具有一个中心通孔7,在离心分离中白血球及血小板层析出在其中。孔7的直径最好是大约1.265毫米以达到必要的血球带伸长从而容许采集目标血球带。浮子6由一个用一种尺寸稳定的透明塑料(诸如苯乙烯硬塑料)制成的一个核心部件9构成。一个套管部件11包围核心9并与之粘接。套管11用一种柔软的透明塑料诸如PVC制成。套管11的两端是制成喇叭口状的,如在13处,并且孔7的两端也是制成喇叭口状的,如在15处,以允许血液在装入与离心分离过程中在管子2中流动。
图3示出管子2如何通过一个输送装置16从一个原始血液采集管14中装入血液,该输送装置具有一个双向穿刺针或套管18。输送装置16包括一个外套筒20,在其中嵌有带针的塞子22。针18在塞子22中延伸进一个第一井口24中,该井口的大小制成能够接纳血液采样管2的加塞端的。套筒20形成一个第二井口26,其大小制成为能够接纳原始血液采集管14的加塞端的。输送针18穿透管14中的塞子28并同时穿透采样管2中的塞子10。管子2中的低压将管子14中的血液通过针18抽吸进管子2中,血液继续流动直到管子2基本上装满为止。一经装满,管子2便被从井口24中抽出并加以离心分离。只要从一个采集管14中输送血液到试管2是单向地装入管子2,非常明显,样本也可使用一根针及该真空管2从一名患者直接采集。
当血液进入管子2时,试剂8将与血液混合,并且管子2将准备好进行离心分离。在离心分离中管子2的闭端4面向外,使得离心分离以后红血球将沉积在管子2的闭端而血浆则靠近管子2的加塞端。图4示出离心分离完成后管子2与血液的状态。红血球30集中在管子2的封闭端而浮子6则嵌入其中并突出在红血球层的顶部以上。构成血沉棕黄层32的白血球与血小板层沉积在浮子6的轴向通孔7中,而血浆34则位于血沉棕黄层与浮子6之上。摇溶凝胶12(或塑料片17)复盖并浮在血浆层34上,从而在离心分离步骤之后从浮子孔7中采集目标血球带过程中运送管子时能够将离心分离后的血液成分层在孔7中固定在一定位置上。
图5示出用一根抽吸针31从浮子孔7中采集目标血球的方法。针31通过塞子10***管子2中,使其尖端23可以定位在目标血球带B中,其余血球带被指定为A、C、D与E。经由针31在带B上作用抽吸力使血球在箭头33所指的方向上运动进入针31。
当装入血样的管子2承受10,000G的离心力时,这是先有技术的毛细管离心分离时所加的力,浮子6的柔软套管部件11径向收缩从而使浮子6的有效直径减小。因此,浮子6被迫通过血样直到它碰到离心分离后的红血球层,这时由于红血球的比重而阻止浮子6继续向前移动。当出现这一情况时,浮子6将被稳定住,并且套管部件11将向外膨胀回到与管腔的紧贴接合。管腔壁上涂有硅酮润滑剂以增进浮子6在管子2中的可滑动性。
本发明的管子能够用于从患者或者从血液采集管中抽取血样,并且血球检验从而得以在加塞的、封闭的管子中直接进行而不存在任何人与污染的血液接触的可能性这一点是深受赞赏的。因而血液检验过程即使对于已知带有污染的血液的患者也能在对检验人员没有危险的情况下进行。在生产管子与浮子中要遵守的尺寸容差得以缓和,并且该检验组件具有较长的贮存期限,因为真空管的内部是充有惰性气体的。由于在管子中的摇溶性物质或者塑料片在离心分离时在血浆顶部形成的薄膜而使得离心分离后运送管子时能够保持血球层带的形成。目标血球可以容易地从清晰可见的浮子孔中的延长了的血球带中采集。
因为不脱离本发明的概念可以对本发明所公开的实施例作出多种多样的改变与变化,除了所附的权利要求书中所要求的以外其它描述都不是旨在对本发明进行限定。
Claims (9)
1.一种血液采样组件,用于从包含在该组件中的经过离心分离的血样中采集目标血球而使执行检验者不与被采样的血液接触,所述组件包括:一个用于盛装血样的透明管子;密封所述管子的一端的一个弹性塞子;以及所述管子的内部具有一个亚大气压强,从而当所述塞子被一根血液采样针穿透时能将血液自动抽吸进所述管中,放置在所述管子中的一个长形浮子部件,并且所述浮子部件可操作以沉入离心分离后的血样的红血球层中,其特征在于所述浮子部件有一个外表面,它在静止状态中与所述管子的腔紧密配合,并且所述浮子部件具有一个受限制的通道,析出的血样血沉棕黄色层进入其中从而扩张血沉棕黄色层中的白血球与血小板层。
2.权利要求1的组件,其特征在于进一步包括在离心分离的、血样顶上形成一个带膜的装置,借此离心分离后的血球层得以稳定以便在采集目标血球中运送该管子。
3.权利要求1的组件,其特征在于所述管子在用该组件抽取血样前充有一种惰性气体。
4.权利要求1的组件,其特征在于所述浮子部件是一个复合结构,它包括一个包含所述通道的尺寸稳定的透明塑料核心,以及一个粘接在并包围所述核心的柔软透明塑料套管,所述套管提供径向可收缩的装置以容许所述浮子部件在血样离心分离过程中承受向心力时能够自由地通过管腔运动。
5.权利要求4的组件,其特征在于所述通道的直径大约为1.265毫米。
6.一种用于从包含在一个管子中的离心分离后的血样中采集目标血球的方法,该管子中同时包含一个浮子,用于伸长血球成分层,其特征在于,
在管子中接纳血液样本,
使管子受离心作用,使得目标血球处于浮子的通道中,允许目标血球的延长,在此条件下,在离心分离过程中通过同时作用一个潮汐样力使浮子的外径收缩,允许浮力自由移动,
通过使浮子的外径管子紧密贴合,在静态中防止浮子滑动,采集处于浮子的通道中的目标血球。
7.权利要求6的方法,其特征在于进一步包括下述步骤:对管子与浮子之间的界面进行润滑以增进浮子通过管子的运动。
8.权利要求6的方法,其特征在于进一步包括下述步骤:将所述管子抽空到将血液自动抽吸进所述管子中所要求的真空度。
9.一种从包含在一个管子中的一种多成分物质样本的一个离心分离后的样本中采集一种目标成分的方法,该管子也包含一个用于伸长目标成分层的浮子,其特征在于包括:
在管子中接纳多成分物质样本,
使管子受离心作用,使得成分层处于浮子的通道中,允许目标血标球的延长,在此条件下,在离心分离过程中通过同时作用一个潮汐样力使浮于的外径收缩,允许浮力自由移动,
通过使浮子的外径与管子紧密贴合,在静态中防止浮子滑动,
采集处于浮子的通道中的目标成分层。
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US63626090A | 1990-12-31 | 1990-12-31 | |
US07/636,260 | 1990-12-31 |
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CN1063163A CN1063163A (zh) | 1992-07-29 |
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CN91112612A Expired - Fee Related CN1033056C (zh) | 1990-12-31 | 1991-12-30 | 一种血样采集方法及其所用的组件 |
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US (1) | US5393674A (zh) |
EP (1) | EP0493838B1 (zh) |
JP (1) | JPH0774772B2 (zh) |
CN (1) | CN1033056C (zh) |
AT (1) | ATE153761T1 (zh) |
CA (1) | CA2058670A1 (zh) |
DE (1) | DE69126293T2 (zh) |
DK (1) | DK0493838T3 (zh) |
ES (1) | ES2104654T3 (zh) |
GR (1) | GR3023914T3 (zh) |
MX (1) | MX9102860A (zh) |
NO (1) | NO303800B1 (zh) |
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-
1991
- 1991-12-26 JP JP3345101A patent/JPH0774772B2/ja not_active Expired - Lifetime
- 1991-12-30 RU SU915010481A patent/RU2088921C1/ru active
- 1991-12-30 EP EP91122385A patent/EP0493838B1/en not_active Expired - Lifetime
- 1991-12-30 DK DK91122385.7T patent/DK0493838T3/da active
- 1991-12-30 MX MX9102860A patent/MX9102860A/es not_active IP Right Cessation
- 1991-12-30 CN CN91112612A patent/CN1033056C/zh not_active Expired - Fee Related
- 1991-12-30 ES ES91122385T patent/ES2104654T3/es not_active Expired - Lifetime
- 1991-12-30 NO NO915134A patent/NO303800B1/no unknown
- 1991-12-30 DE DE69126293T patent/DE69126293T2/de not_active Expired - Fee Related
- 1991-12-30 AT AT91122385T patent/ATE153761T1/de not_active IP Right Cessation
- 1991-12-31 CA CA002058670A patent/CA2058670A1/en not_active Abandoned
-
1993
- 1993-03-08 US US08/025,343 patent/US5393674A/en not_active Expired - Fee Related
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1997
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Also Published As
Publication number | Publication date |
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EP0493838B1 (en) | 1997-05-28 |
CN1063163A (zh) | 1992-07-29 |
EP0493838A1 (en) | 1992-07-08 |
CA2058670A1 (en) | 1992-07-01 |
NO303800B1 (no) | 1998-08-31 |
JPH0774772B2 (ja) | 1995-08-09 |
ATE153761T1 (de) | 1997-06-15 |
MX9102860A (es) | 1992-07-01 |
ES2104654T3 (es) | 1997-10-16 |
DK0493838T3 (da) | 1997-07-28 |
NO915134D0 (no) | 1991-12-30 |
JPH04303730A (ja) | 1992-10-27 |
RU2088921C1 (ru) | 1997-08-27 |
DE69126293T2 (de) | 1998-01-15 |
NO915134L (no) | 1992-07-01 |
GR3023914T3 (en) | 1997-09-30 |
DE69126293D1 (de) | 1997-07-03 |
US5393674A (en) | 1995-02-28 |
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