CN1652730A - 全血采样设备 - Google Patents

全血采样设备 Download PDF

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CN1652730A
CN1652730A CNA038104288A CN03810428A CN1652730A CN 1652730 A CN1652730 A CN 1652730A CN A038104288 A CNA038104288 A CN A038104288A CN 03810428 A CN03810428 A CN 03810428A CN 1652730 A CN1652730 A CN 1652730A
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迈克尔·L·贝尔
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Beckman Coulter Inc
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Abstract

一种具有自充能力的便携手持式血液采样设备(10)，包括血液分离过滤器(30)。所述过滤器(30)具有多个细孔(42)，其尺寸允许例如血浆这种所选的血液成分通过设备(10)。所述设备(10)具有分离的血液的导管24，所述导管24延伸超出设备(10)的出口(16)并形成容易刺穿血液分析器的自密封隔膜的形状。环形护罩(27)从设备出口(16)延伸超出导管(24)以防止使用者无意地接触到导管(24)。

Description

全血采样设备
发明领域
本发明涉及用于从全血中提取诸如血浆这样的血液成分的便携手持式设备。
发明背景
本领域中血液采样设备的使用是已知的。典型地，使用手指刺或伸缩管从病人采集血液样本。如本领域中所认识到的，所获样本难以分析。例如，样本包含易变的部分细胞，该细胞影响非平衡化验中所测量的分析物的量化。血液样本受到凝块最终堵塞典型血液分析器中的小通道的结果的影响。血液样本中包含易碎的血细胞，如果破裂，其会改变一些分析物的浓度。而且，非常多的血细胞数目会超出基于血细胞计数器的分析器的读取能力。本领域中已知一些采样设备，例如，美国专利.5,919,356中说明的分析器，使用可刺入病人的针通过抽注射器的活塞来取血，接着血液流入包含隔膜纤维的室。通过摇动设备或挤压注射器的活塞完成通过隔膜的过滤。分离的样本包含在收集器室中。这种类型的设备不设计用于血液分析器。此外，现有技术的设备，例如上述设备，需要通过针/注射器装置刺破病人的皮肤以从病人采集不必要的大量血液。这就对于皮肤针刺敏感的病人有潜在的外伤影响。本发明用于克服现有技术的缺点。
发明内容
本发明涉及一种用于收集血液样本的设备，该血液样本通过使用血液分析器分析。该设备包括中空的不透流体的管，所述管具有限定入口室的入口端和用于流体从管的内部排出的出口端。入口开孔用于接收血液样本并具有在管的内部沿一段管延伸的中空纤维过滤器。过滤器在贴近入口端的第一端密封，在第二端与出口端有流体连通。过滤器置于管内适于从血液样本中分离包括血浆在内的血液成分，并通过管的出口排出分离的血液成分。过滤器包括多个大小适于限制流体从入口室流到过滤器内部的孔。这就防止当提供血浆穿过过滤器的通道时全血和血细胞从通道进入过滤器的中空部分。所述孔能具有大约2微米的直径，可选地，是从大约0.1微米到1微米。此外，所述孔能沿从过滤器的第二端到距过滤器第一端预定的距离之间的一段纤维过滤器布置。位于管内的入口室具有含可吸收表面的壁以及横截面，所述横截面大小上使得在管内的过滤器的相对尺寸为设备通过毛细作用而具有自充能力做准备，从而在一个设备中将血液分离过滤和自充能力结合在一起。入口室能包含抗凝剂以抑制凝块。
设备的出口端包括用于不透流体密封的端盖。所述端盖包括在设备出口端从管内部延伸到的管外部的中空斯藤件或导管。所述斯藤件或导管具有锥形端以容易地穿到分析器的隔膜中，该隔膜担当分析器总管中的自闭样本入口通道。所述端盖能包括围绕出口端布置的出口护罩。所述出口护罩能形成超出斯藤件的尺寸，使其距出口的距离大于分离血液的导管距出口的距离。所述护罩防止设备使用者无意接触导管。这就保护样本不受到使用者的任何污染并防止使用者接触受到污染的样本。
实际中，一滴血在设备入口引入，由于管的可吸收内表面和内部填充容积的联合影响，血液在毛细作用下吸入设备。所述设备置于分析器上，以便分离血液的导管穿透入口通道隔膜，其中，由分析器抽成的真空来吸入血液样本通过分离过滤器，从而将分离的血液，例如血浆，引入到分析器中。
作为本发明可选的实施例，设备的入口可形成适于刺入病人皮肤的尖突，以当做抽血刺血针，所述护罩可以是固定设备的形状，例如Luer锁。作为上述特征的结果，本发明的特征在于，需要临床分析器、其紧凑而便于携带、在相对短的时间内提供少量的血浆、比传统的一次性采血设备相对便宜、保护操作人员不与潜在的感染样本接触并且不需要专用的设备来从细胞中分离血浆。
附图简述
图1A是本发明实施例的剖视图；
图1B是图1A实施例的局部剖切的透视图；
图2A是图1A的发明的可选实施例；而
图2B是图2A实施例的局部剖切的透视图。
发明详述
现参考所述附图，图中显示本发明血液采样设备的实施例。更具体地，图1A和2A显示由具有入口端14和出口端16的中空圆柱形管12形成的设备10。管12可由多种常规材料中的任意一种制造，例如本领域中已知的硬塑料。出口端16包括以不透流体形式固定到管12的端盖18。所述端盖18例如可通过流体不溶解粘合剂等固定到管12。该端盖18具有周向重叠出口16的重叠部分20，并且流体密封O形圈22在管12与重叠部分2之间环形地位于各自的凹槽中，以便在出口16提供进一步的流体密封。尽管端盖18显示为设备组件的一部分，但是应该理解，所述端盖18可作为管12的一部分一体地制造，这也在本发明的考虑之内。
端盖18包括相对较小的类似斯藤件的导管24，该导管延伸穿过由管出口限定的边界到刚超出出口16的位置。斯藤件24超出出口16的部分26稍微呈圆锥形的剖面，将在以后讨论，以方便斯藤件24穿入血液样本分析器总管的自闭样本入口通道。环形护罩27从端盖18向外延伸到超出斯藤件锥形部分26的远端的位置。护罩27减少在操作设备10期间收缩管24的无意接触的可能性，以保持斯藤件24在使用期间免受污染并避免使用者接触受到污染的样本。
所述斯藤件部分28在管12的内部延伸一段足以与过滤器30配合的距离。斯藤件部分28包括向外延伸的环形圆形突出部32，其形成的尺寸可安全地安装在位于过滤器远端36附近的过滤器环形凹槽34中。过滤器30可通过压配合排列或使用本领域中已知的粘合剂固定到斯藤件部分28。设备入口14限定入口室38，过滤器30从端盖18之间基本上延伸管12内部的长度到入口室38中。过滤器30大体是管形的，具有环形横截面、密闭端40和打开端36，如上所述该打开端36与斯藤件部分28呈不透流体关系安装在其上。由自然不能渗透通过全血的隔膜形成，如图1B和2B所示，过滤器30具有多个沿过滤器壁周围布置的孔42。过滤器30和管12的内部之间的区域46、包括入口室38限定了容纳在入口14引入的全血的填充容积。所述孔42穿过过滤器壁44，其大小限制仅仅让血浆流动通过过滤器壁44进入过滤器内部48。孔尺寸大约2微米的直径，优选地是在大约0.1-1.0微米范围内。随后将讨论到，在外部血液分析器的吸出作用下将血浆吸入过滤器内部48以及穿过斯藤件24从设备10吸出的过程。孔42位于起始于过滤器远端36并向密闭端40前进一定距离的区域内，所述距离对应于大约一半初始血液填充容积。管12具有达到包括可吸收内表面条件的内壁50。管12的横截面形成的尺寸以便和内壁50的可吸收内表面特征相结合，设备通过毛细作用自充。就这点而言，管容积的大小在0.5毫升的范围而管内径的范围大约是1毫米。相应地，当设备充满血液时，与血液相联系的重量小于大约5克。过滤器30基本上是圆柱形，其尺寸使得直接围绕过滤器的容积应完全覆盖在血液中，即使血液量不足以完全充满管12。为防止装在管12之内的血液凝块，将抗凝剂52，优选地为干燥形式，散布到整个管12的内部。使用这种方式，促进血浆从管12流过过滤器30。
在实践中，结合所述设备和血液分析器的使用如下。一滴血在设备入口端14引入；试样量的血液在毛细作用的影响下进入管12。在进入管12时，血液溶解抑制血液凝块的抗凝剂52。由于设备10的自充性质，不论设备的方位如何，样本保持在管12之内。随着在管12中引入样本，设备使用者将端盖18插入到血液分析器的采样端口。斯藤件部分26穿过分析器总管中的自闭入口通道。典型的自闭技术和装置使用可刺穿的柔性材料隔膜，比如硅树脂橡胶。一旦设备10插入到分析器的采样端口，分析器泵通过采样入口14吸气以形成相对于环境的负压。负压将血浆从管12的血液样本中，经过孔42吸入到过滤器48的内部，最终进入分析器总管。由于采样设备10通过入口14排放，上述操作不需要另外的排出口。在吸入上述样本之前吸入了不定量的空气。分析器泵分配样本的第一部分消耗于处理所述空气。一旦已经吸入了足够的样本，分析器在管12内发送围绕和通过斯藤件24的清洗流体来清除可能污染设备入口14外表的小滴样本。接着，操作员移除设备10，该设备关闭分析器的自闭入口以便清洗流体可以通过端口流通而不必考虑泄漏或者吸入空气。重要地，伸出的端盖护罩有助于防止操作员接触可能被样本污染的斯藤件24。
此外，从斯藤件24吸入时，当血浆穿过细孔42移经过滤器壁44时会存在流阻。血浆的流阻大于空气的流阻。如果过滤器30由于填充不完全被血液部分围绕也被空气部分围绕，由于较小阻力的空气路径存在将会使流体回路短路。相应地，如图1B和2B所示，孔42的分布终止于过滤器闭合端40，否则在分离少量血浆之后，空气会与过滤器30接触使得血浆流短路。在所有需要的分离样本产生之前，空气不应接触过滤器30的多孔区域。设备10产生的分离血浆容积不大于大约血液样本容积的一半，因为血液样本的另外一半是血细胞。从样本移除血浆量将降低填充高度，一旦填充高度小于过滤器30的多孔区域的高度，将不再有进一步的分离。为获得最大量的血浆，过滤器30的多孔部分应终止于相应于不高于初始血液填充高度一半的高度位置。
本发明的可选实施例如图2A和2B所示。与图1A所示在入口14的平切口形状不同，设备10在入口14’具有相对于伸长管12成一定角度的切口，以便产生尖突54。该尖突54作为刺血针刺破病人的皮肤来获取少量血液样本。由于设备10的自充性质，仅仅需要从病人吸取填充设备所需的少量血液，使得取血液的过程十分快速和有效。
尽管本发明已参考一定的优选型式进行了相当详细的说明，但是许多其它的形式对于本领域的技术人员应该是显而易见的。因此，所附权利要求的精神和范围不应限制于此中优选型式的说明。

Claims (16)

1.一种血液采样设备，包括：
中空不透流体管，该管具有限定入口室的入口端和用于将流体从管内部排出的出口端；以及
在管的内部沿一段管延伸的中空纤维过滤器，所述过滤器在贴近入口端的其第一端处密封，并在其第二端处与出口端流体连通，其中所述过滤器包括多个尺寸适于限制流体从入口室通到过滤器内部到达血浆的孔。
2.按照权利要求1的设备，其中，所述管的出口端包括用于提供出口端不透流体密封的端盖，所述端盖包括从管内部延伸到管出口端处的管外部的中空斯藤件。
3.按照权利要求1或2的任一权利要求的设备，其中，所述纤维过滤器以不透流体密封的形式安装到所述斯藤件，以便提供血浆从过滤器内部排出的通道。
4.按照前述权利要求中的任一权利要求的设备，其中，所述端盖包括围绕出口布置的出口护罩，所述出口护罩形成超出斯藤件的尺寸以便保护所述斯藤件。
5.按照前述权利要求中的任一权利要求的设备，其中，所述入口室限定(a)具有可吸收表面的入口室壁；和(b)尺寸上便于入口室在毛细作用的影响下自充的横截面。
6.一种血液采样设备，包括：
中空不透流体管，其具有
限定用于接收要采样的血液的入口室的入口和用于流体从管内部排出的出口，所述入口室限定(a)具有可吸收表面的入口室壁；和(b)尺寸上便于入口室在毛细作用的影响下自充的横截面；以及
血液分离过滤器，所述血液分离过滤器置于管内，适于从血液中分离血液成分并将这种分离的血液成分从所述管的出口端排出。
7.按照权利要求6的血液采样设备，其中所述分离过滤器包括一端密封而另一端与出口连接的中空细长纤维过滤器，所述过滤器具有多个孔以提供血液成分从入口室到所述过滤器内部的通道。
8.按照权利要求6或7的任一权利要求的血液采样设备，其中，将所述孔的尺寸定为限制血液成分流到血浆。
9.按照权利要求6-8中的任一权利要求的血液采样设备，其中所述出口包括用于提供出口的不透流体密封的端盖，所述端盖包括在其设备出口端从管内部延伸到管外部的中空斯藤件，所述斯藤件与过滤器有流体连通以将过滤器中的物质从设备中排除，并且，所述端盖还包括围绕所述出口布置的出口护罩，所述出口护罩能形成超出所述斯藤件的尺寸以便保护所述斯藤件。
10.按照权利要求1-5和7-9中的任一权利要求的设备，其中，所述孔沿所述过滤器的第二端和距管第一端预定的距离之间的一段纤维过滤器布置。
11.按照权利要求1-5和7-9中的任一权利要求的设备，其中，所述纤维过滤器具有小于所述入口室的横界面的横截面，从而限定两者之间的填充容积。
12.按照权利要求10或11的任一权利要求的设备，其中，所述预定的距离在对应于小于填充容积一半的位置。
13.按照权利要求5-9中的任一权利要求的设备，其中，所述入口室包含抗凝剂来抑制凝块。
14.按照前述权利要求中的任一权利要求的设备，其中，所述入口包括适于刺破病人皮肤来从其吸入血液的尖突。
15.按照前述权利要求中的任一权利要求的设备，其中，所述孔具有大约为2微米的直径。
16.按照前述权利要求中的任一权利要求的设备，其中，所述孔具有大约在0.1-1.0微米的范围内的直径。
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US6755802B2 (en) 2004-06-29
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