CN102056637A - 三管路单采血液成分系统和方法 - Google Patents

三管路单采血液成分系统和方法 Download PDF

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CN102056637A
CN102056637A CN2009801208146A CN200980120814A CN102056637A CN 102056637 A CN102056637 A CN 102056637A CN 2009801208146 A CN2009801208146 A CN 2009801208146A CN 200980120814 A CN200980120814 A CN 200980120814A CN 102056637 A CN102056637 A CN 102056637A
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艾蒂安·佩奇斯
麦克尔·拉古萨
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Abstract

本发明公开了一种用于采集和交换血液成分的血液处理系统(100),其包括用于抽取血液并将血液成分输回对象的静脉接入装置(110)。血液抽取管路(120)将所述静脉接入装置(110)与血液成分分离装置(150)流体连接。与抗凝血剂源(134)连接的抗凝血剂管路(130)将抗凝血剂引入抽取的全血中。与静脉接入装置(110)和血液成分分离装置(150)流体连接的回输管路(140)将未采集的血液成分输回对象。抽取泵(122)、抗凝血剂泵(132)和回输泵(142)分别控制经过所述抽取管路(120)、所述抗凝血剂管路(130)以及回输管路(140)的流动。所述血液成分分离装置(150)将抽取的血液分离成第一血液成分和第二血液成分。所述分离装置(150)可将所述第一血液成分输送至袋中。

Description

三管路单采血液成分系统和方法
优先权
此专利申请要求以下美国专利申请的优先权:
2008年4月14日提交的题为“Three-Line Apheresis System and Method(三管路单采血液成分系统和方法)”的美国专利申请号12/102,407,分配的代理人案号为1611/A51,其公开内容在此以其全文引为参考。
技术领域
本发明涉及用于血液处理的系统和方法,尤其涉及三管路单采血液成分系统以及使用该系统的方法。
背景技术
单采血液成分术(Apheresis)是能够从对象暂时抽出的全血中分离和采集单个血液成分的程序。通常,经由插入对象手臂和插入细胞分离器如离心转筒的针头抽取全血。一旦将全血分离成各种成分(例如血浆、红血细胞、白细胞和血小板),就可从离心转筒移出一种或多种成分。剩余的成分和任选的流体补偿一起输回对象内,以补偿失去成分的量。
对单采血液成分系统的一个考虑是程序期间的体外量(ECV),或者说是体外全血的量。出于供体的安全性考虑并为了提高供体对程序的耐受度,体外量应减小到最低程度。对ECV的限制已产生了多种单采血液成分系统和分离装置设计。例如,当今的单采血液成分系统通常采用连续流动分离装置或者非连续流动分离装置。连续流动分离装置在分离过程中通常不会在装置内积聚分离的成分(尽管分离装置的外部可加上容器)。相反,血液成分通常在非连续分离装置内积聚,并随后从该分离装置被移出或提取。
连续和非连续分离装置之间的另一显著差异是各自具有的接入口数量。具体而言,连续流动分离装置通常具有至少3个接入口(用于抗凝的全血的1个输入口和2个成分输出口),而非连续分离装置只具有2个端口(入口和出口)。
采用非连续分离装置(例如双端口离心转筒)的单采血液成分系统经由导管从供体或患者将全血抽取到发生成分分离的离心转筒中。当转筒中的量足够时,停止新鲜血液的抽取,且经由同一导管间歇性地将不需要的成分输回供体或患者,这造成了延迟时间,并增加了整个过程的时间。当已经完成回输时,再次从供体或患者抽取全血,开始第二个周期。这样的分批处理一直持续到采集到所需量的成分为止。
发明内容
根据本发明的实施例,血液处理系统可采集、移出和交换血液成分。该血液处理系统可以是非连续系统,并可包括用于静脉接入装置和血液成分分离装置,其中静脉接入装置从对象抽取全血并将血液成分输回对象。血液成分分离装置将抽取的血液分离成至少第一血液成分和第二血液成分,并可构造成将第一血液成分输送至第一血液成分袋。血液成分分离装置还可具有出口,并可经由出口交替排放第一血液成分和第二血液成分。血液处理系统还可具有多个管路,包括但不限于血液抽取管路、抗凝血剂管路和回输管路。管路专用泵可控制经过每个管路的流动。
血液抽取管路可与静脉接入装置流体连接,并构造成将抽取的全血输送至血液成分分离装置。血液抽取泵可控制经过血液抽取管路的流动。抗凝血剂管路可连接至抗凝血剂源,并可将抗凝血剂引入抽取的全血,例如在靠近静脉接入装置处。抗凝血剂泵可控制经过抗凝血剂管路的流动。回输管路可与静脉接入装置和血液成分分离装置流体连接,并可用于将第二血液成分或补偿流体输回对象。回输泵可控制经过回输管路的流动。在某些实施例中,回输管路在抽血泵与静脉接入装置之间的点处与静脉接入装置流体连接。
根据其它实施例,血液成分分离装置是离心转筒,并将抽取的血液除第一血液成分和第二血液成分以外,还可分离成的第三血液成分。通过回输管路,除第二血液成分以外,还可将第三血液成分输回对象。第一血液成分可以是血浆,第二血液可以是红血细胞,而第三血液成分可以是血小板或其它血细胞。或者,第一血液成分可以是血小板,而第三血液成分可以是血浆。
根据其它实施例,浪涌淘析(surge elutriation)步骤可用于用盐溶液或其它补偿流体从转筒中提取血浆。另外,该系统可包括位于血液成分分离装置与静脉接入装置之间的回输管路上的阀门。该阀门停止回输管路中的流动。在浪涌淘析的过程中,血液成分分离装置可将第一血液成分输送至第一血液成分袋。该系统还可具有位于回输管路内用以容留血浆的血浆贮存器。
根据本发明的其它实施例,运用了采集和交换血液成分的方法。该方法包括将静脉接入装置插入对象,并从对象抽取血液。静脉接入装置可连接至抽取管路、抗凝血剂管路和回输管路。该方法经由连接至血液成分分离装置的抽取管路从对象抽取血液。抽取管路泵控制经过抽取管路的流动。该方法还可经由抗凝血剂管路将抗凝血剂引入抽取的血液中。抗凝血剂管路泵控制经过抗凝血剂管路的流动。从对象抽取的血液量不是必需装满血液成分分离装置。
一旦抽取的血液处于血液成分分离装置内,该方法就将抽取的血液分离成第一血液成分和第二血液成分,并从血液成分分离装置中提取第一血液成分。然后,该方法可经由回输管路将第二血液成分输回对象,所述回输管路与抽取管路泵与静脉接入装置之间的点处与静脉接入装置流体连接。回输管路泵控制经过回输管路的流动。血液成分分离装置可以是离心转筒。
根据其它实施例,方法还可在将第二成分输回患者时暂停抽取血液,并重复一些或全部步骤,直到提取到目标血浆量。另外,方法还可监测回输管路内的压力,并基于监测到的压力调节回输管路内的流体流动,以保持压力在所需压力范围内。方法还可在从对象抽取血液之后将一定量的补偿流体输回对象,以补偿抽取的血液量。
根据其它实施例,用于采集和交换血液成分的血液处理系统可包括用于从对象抽取全血并将血液成分输回对象的静脉接入装置。系统还可具有双端口血液成分分离装置,其将抽取的血液分离成第一血液成分和第二血液成分,并将第一血液成分输送至第一血液成分袋。血液处理系统还可具有多个管路,包括但不限于血液抽取管路、抗凝血剂管路和回输管路。管路专用泵可控制经过每个管路的流动。
血液抽取管路可与静脉接入装置流体连接,并构造成将抽取的全血输送至血液成分分离装置。血液抽取泵可控制经过血液抽取管路的流动。抗凝血剂管路可连接至抗凝血剂源,并可将抗凝血剂引入抽取的全血中,例如在靠近静脉接入装置处。抗凝血剂泵可控制经过抗凝血剂管路的流动。回输管路可与静脉接入装置和血液成分分离装置流体连接,并可用于将第二血液成分或补偿流体输回对象。回输泵可控制经过回输管路的流动。在某些实施例中,回输管路在血液抽取泵与静脉接入装置之间的点处与静脉接入装置流体连接。双端口血液成分分离装置可以是离心转筒。第一血液成分可以是血浆,而第二血液成分可以是红血细胞。或者,第一血液成分可以是血小板,而第二血液成分可以是血浆。
附图说明
结合参考附图参阅以下详细说明之后,将能更容易地理解本发明的前述特征,所述附图中:
图1示意性地示出了现有技术的双端口单接入血液处理系统的总体构造。
图2示意性地示出了根据本发明实施例的三管路单接入系统的总体构造。
图3示意性地示出了根据本发明实施例的三管路单接入系统的更详细构造。
图4示意性地示出了根据本发明一个实施例,用于图1的机器的双端口离心转筒的侧视图。
图5示出了根据本发明实施例,包括图2、图3和图4所示的单采血液成分系统的部件的一次性套件的实施例。
图6示出了应用根据本发明一个实施例的三管路单接入系统的一种方法的步骤的流程图。
图7示出了应用根据本发明另一实施例的三管路单接入系统的第二种方法的步骤的流程图。
具体实施方式
本发明的实施例提供了一种用于执行血液单采分离程序的系统和方法。具体的实施例提供三管路单接入血液单采成分系统,该系统缩短了总过程时间,只存在有限的“死时间”,减小了体外量,处理了所抽取的全部血液,并使抽取的血液与处理过的回输血液的接触最少。该方法和系统可采用专用管路从对象抽取血液,将抗凝血剂引入抽取的血液中,并将不用或处理过的血液成分输回对象。下面将论述说明性实施例的细节。
如图1所示,且如上所述,采用双端口分离装置(例如离心转筒12)的现有技术系统10经由导管14从供体或患者将全血抽取到发生成分分离的离心转筒12中。转筒12中的量足够时,系统10停止抽取全血,采集所需成分(例如通过管路19和袋18采集血浆和/或通过管路20和袋22采集血小板),并经由同一导管14将不需要的成分间歇性地输回供体或患者,这产生了延迟时间并增加了总过程时间。回输步骤结束时,再次从供体或患者抽取全血,开始第二个周期。这种分批处理一直持续到采集到所需量的成分为止。重要的是要注意,由于离心转筒12上只有两个端口,提取的成分在分流到它们各自的导管(例如血浆袋管路19和血小板袋管路20)中之前共用一节导管17。
相形之下,如图2所示,本发明的实施例通过专用管路从对象抽取全血并将未提取和/或不需要的成分输回对象。具体而言,血液处理系统100经由可插入对象手臂的静脉接入装置110从对象抽取全血。静脉接入装置110可具有从其延伸的三个管路。第一管路,血液抽取管路120,将静脉接入装置110与血液成分分离装置150流体连接。因此,随着从对象抽取全血,血液经过静脉接入装置110,通过抽取管路120到达血液成分分离装置。位于抽取管路上的抽取泵122控制经过抽取管路120的抽取流动的方向、流速和时长。
从对象抽取全血时,可将抗凝血剂添加到全血中,以防止血液在管路内或血液成分分离装置150内凝结。为此,系统可包括抗凝血剂管路130,抗凝血剂管路的一端与抗凝血剂源134(例如抗凝血剂袋)流体连接,而另一端与静脉接入装置110(或抽取管路120)流体连接。抗凝血剂管路130经过的抗凝血剂泵132可控制经过抗凝血剂管路130的流动以及被引入全血的抗凝血剂量。某些实施例中,抗凝血剂泵132与抽取泵122成比例运转,以确保将适量的抗凝血剂添加到全血中。尽管能在任意点将抗凝血剂添加到全血中,但优选地将抗凝血剂尽可能靠近静脉接入装置110引入全血中。重要的是注意任何管路/导管都可包括钳式阀(clamp valve)164,用以停止管路内的流动。
一旦从对象抽取到所需量的抗凝全血,并将其容纳在血液成分分离装置150中,血液成分分离装置就将全血分离成若干血液成分。例如,血液成分分离装置可将全血分离成第一、第二和第三血液成分,或许还有第四血液成分。更具体地说,血液成分分离装置150能将全血分离成血浆、血小板、红血细胞,可能还有白细胞。
如以下更详细的论述,血液处理系统100的某些实施例可包括输送泵210以及连接至血浆袋158的稀释/提取管路160。输送泵210和稀释/提取管路160可具有多种用途,包括稀释被引入血液成分分离装置中的抗凝抽取血液。例如,如果用户想要抽取的血液具有更高的血浆含量,该系统可开动输送泵,并将血浆从血浆袋158引入抽取管路120内的抽取血液来稀释抽取的血液。此外或替代,可在(下面将作详细描述的)浪涌淘析过程中用输送泵将血浆从血浆袋158引入血液成分分离装置150,以提取血小板(或其它血液成分)。
尽管有多种血液成分分离装置150可用于将全血分离成血液成分,但本发明的一些实施例采用通过引用并入本文的美国专利No.3,145,713所述的标准Latham式离心机。但是,本发明的其它实施例可采用其它血液成分分离装置150,例如但不限于通过引用并入本文的美国专利No.4,983,156和No.4,943,273所述的整体吹塑成型离心转筒。
如图4所示,采用Latham离心机11时,血液成分分离装置150包括可旋转筒12以及通过旋转式密封件74与转筒内部的固定输入和输出口PT1和PT2流体连接。抽取管路120流体连接静脉接入装置110(例如静脉插针)和输入口PT1。某些实施例中,如果先汇集全血然后加以供应,则可用全血袋(未示出)来代替静脉接入装置110。在此类实施例中,抽取管路120将使得全血袋与输入口PT1流体连接。
如上所述,血液成分分离装置150将全血分离成组成成分。具体而言,随着转筒12旋转,离心力将进入转筒底部的抗凝全血分离成红血细胞(RBC)、白血细胞(WBC)、血小板和血浆。转筒12的转数可选择在例如4,000至6,000rpm的范围,且通常为4,800rpm。根据成分密度将血液分离成不同级分。高密度成分、即RBC60被推向转筒12的外壁70,而低密度血浆66位于更靠近中心72。在血浆66与RBC 60之间形成棕黄层61。棕黄层61由血小板的内层64、血小板和WBC的过渡层68以及WBC的外层62组成。血浆66是从分离区起最接近出口的成分,并且是随着添加的抗凝全血经由入口PT1进入转筒12,通过出口PT2从转筒12排出的第一流体成分。
一旦血液成分分离装置150已将血液分离成各种成分,就可将一种或多种成分从血液成分分离装置150中移出。例如,可将血浆经由管路152移动到血浆袋158(图2和图3),或经由管路222到废液袋220(图3)。或者,可将血浆移动到位于回输管路140上的血浆贮存器(未示出)。随后,可以渐增的速率将移出的血浆(或补偿流体)再次引入血液成分分离装置150,以提取血小板,并通过管路154将血小板输送至血小板袋156。此处理叫作浪涌淘析。一旦将所需成分从血液成分分离装置移出,系统就可将剩余成分输回对象。系统可通过专用回输管路140将这些成分输回对象。回输管路140流体连接血液成分分离装置150和静脉接入装置110。在优选实施例中,回输管路140在血液抽取泵122与静脉接入装置110之间的点处与静脉接入装置110流体连接。与抗凝血剂管路130和抽取管路120一样,回输管路140也具有专用泵142。回输泵142控制回输管路142内流体流动的方向、流速和时长。某些实施例中,系统还可具有与回输泵142上游的回输管路140流体连接的血浆回输管路162。血浆回输管路162使得系统100能将血浆袋158内包含的血浆输回对象。血浆回输管路162可利用回输泵142将血浆输回对象。
根据某些实施例,系统100可以非连续分批式处理来抽取全血,将其分离成成分,并从血液成分分离装置提取血液成分。例如,系统100可从对象抽取全血,直到特定的量在血液成分分离装置150内。系统100然后可分离血液成分分离装置150中包含的血液,采集所需的血液成分,并将剩余血液成分输回对象。然后,系统100可从对象抽取更多的全血,并重复处理,例如直到采集到预定量的血液成分。某些实施例中,尤其是在血液成分分离装置150上只具有单个出口的实施例,血液成分分离装置150可经由同一出口(例如图4所示的PT2)交替排放第一血液成分和第二血液成分。例如,血液成分分离装置150可先将血浆排放到血浆袋158中,然后经由同一出口将剩余的血液成分输回对象。
如图3所示,除上述系统部件以外,系统还可包括帮助便利整个系统的操作的多个阀门、过滤器、压力监测器和传感器。具体而言,每个上述管路可包括管路中的过滤器。例如,回输管路140可包括回输血液成分必须经过的血液过滤器240。另外,抗凝血剂管路130可包括防止抗凝血剂源134中的任何细菌进入系统的滤菌器265。尽管抽取管路120可具有血液过滤器(未示出),但应注意的是,与采用相同管路从对象抽取血液和回输不用成分的传统系统不同,本发明的实施例不需要抽取管路120上的过滤器。具体而言,这是由于回输管路包括过滤器,该过滤器除去可能存在于输回人体的流体中的任何污染物。省去抽取管路上的过滤器,抽取步骤可以更迅速而有效,且抽取泵工作起来不必那么吃力。或者,系统可采用较小容量的泵。此外,避免抽取管路120上的过滤且不使用同一管路来抽取全血和回输血液成分,防止了潜在的微团块在过滤器与分离装置150之间往复移动。
如以下更详细的论述,系统可具有位于整个系统内的多个阀门,用以控制流体在系统内的流动。例如,回输管路和抽取管路可包括打开时允许经过管路而在关闭时阻止流动的阀门(例如分别为阀门281和280)。此以,通向贮存袋和废液袋156、158和220的每个管路152、154、222和232,以及补偿流体源230可具有类似的阀门(例如分别为阀门285、284、286和287)。另外,通向血液成分分离装置150的入口可具有阀门282和283,这两个阀门允许或阻止向或自血液成分分离装置150的流动。阀门可以是手动的或自动的。换言之,在符合特定条件(例如下面将作描述的,回输管路阀门281在管路140中检测到空气时关闭)时,阀门可由用户/技术人员手动操作,或者例如由控制器自动操作。
还应注意的是,上述任一或所有管路均可包括用以检测管路中空气的存在的空气检测器。例如,回输管路140可包括空气检测器250。管路中存在气泡会对系统的运行造成问题,而且如果气泡进入血流中还可能对对象造成伤害。因此,可将空气检测器250连接至联锁装置,该联锁装置在检测到气泡的情况下停止回输管路140内的流动(例如通过停止回输泵142或者关闭回输管路140上的阀门281),从而防止气泡进入对象。另外,在某些实施例中,回输管路140还可包括空气阱(air trap)270。空气阱270可用于除去输回对象的流体(例如血液成分或补偿流体)中的任何空气。
另外,如图3和图4所示,血液成分分离装置150可包括位于输出口PT2附近的管路传感器260。管路传感器260可以是光学传感器,其包括发光透过经输出口PT2和传感器260的流体的LED。与LED灯相对布置(例如流体的相对侧上)的光电探测器接收通过流体的光,并能基于接收的光的量确定经过的流体的密度。根据该计算出的密度,管路传感器260能确定经过传感器的成分的种类(如血小板或血浆)。某些实施例中,管路传感器260可连接至上述一个或多个阀门,并可(例如直接或经由控制器)控制阀门的操作。例如,如果管路传感器260检测到表示经过传感器的流动从血浆变为血小板的密度变化,则管路传感器260可关闭通向血浆袋158的阀门,并打开通向血小板袋156的阀门。
系统还可包括再循环泵210,该循环泵使得流体在系统中再循环,并从血液成分分离装置150抽取血液成分。例如,再循环泵210可用于移出血液成分分离装置150中的血浆,或者在以下将作论述的浪涌淘析过程中从补偿流体源230将补偿流体输送至血液成分分离装置150。
如图5所示,可将上述系统和对应部件包装在一起成一次性套件500。一次性套件500可包括血液处理所需的一些或全部一次性部件。例如,一次性套件特别可包括抽取管路120、回输管路140、抗凝血剂管路130、所有的其它系统管路、用以阻止给定管路中的流动的多个阀门164、血小板袋156、血浆袋158、抗凝血剂过滤器265以及静脉接入装置110。因此,用户/技术人员要执行血液单采成分处理时,他们只需打开预先组装好的一次性套件,并将部件安装在适当的单采血液成分机中。另外,单采血液成分处理结束时,用户/技术人员只需拆除一次性部件,并对其进行适当处置即可。
图6示意性地示出了描述使用上述三管路单接入单采血液成分系统的方法的流程图。具体而言,该方法中,首先将静脉接入装置110插入对象(步骤610),然后开始经由抽取管路120抽取全血(步骤620)。如上所述,由抽取泵122控制抽取管路120内流动的方向、流速和时长。在从对象抽取全血时,抗凝血剂泵132通过抗凝血剂管路130从抗凝血剂源134将抗凝血剂引入全血(步骤630)。如上所述,抗凝血剂防止全血在系统内凝结。
一旦抗凝的全血到达血液成分分离装置150,血液成分分离装置就以上述的分层定向(layered orientation)将血液分离成组成成分(例如红血细胞、血浆、血小板和白细胞)(步骤640)。然后,操作系统的技术人员可提取一种或多种成分(提取的成分取决于程序的目的)(步骤650),并将剩余的血液成分输回对象(步骤660)。如上所述,通过回输管路140和回输泵142将回输的成分输回对象。在回输过程期间,抽取管路120和抽取泵122可通过关闭位于抽取管路120上的阀280与供体(以及回输管路140)隔离。另外,在回输过程期间,抗凝血剂泵132可停止,以防止抗凝血剂流动。如果获取或采集到目标量的成分(步骤670),则结束程序。另外,系统可用于通过重复步骤620至660获取/采集第二批成分。
根据其它实施例,并如图7所示,采用三管路单接入单采血液成分的方法还可包括若干其它任选步骤。具体而言,在经由抽取管路抽取到一定量全血(步骤620)并引入抗凝血剂(步骤630)之后,方法可暂停抽取(步骤710),并将补偿流体输回对象(步骤712)。补偿流体可通过回输管路140和回输泵142输回对象,以大幅缩短在抽取步骤和回输步骤之间转换所需的停工时间。输回对象的补偿流体的量可与从患者抽取的全血的量基本接近,或者可以计算出的待移出血液成分的量为基准(例如待移出的血浆的量)。将适量的补偿流体输回对象之后,方法此时可停止回输,并重新开始抽取全血(步骤715),例如直到血液成分分离装置中分离到预定量的红血细胞为止。通过以此方式向对象回输补偿流体(例如暂停抽取步骤,以回输补偿流体),可减少任意给定时刻下的体外量,且对象对程序的耐受度也增强。
应注意的是,从对象抽取的全血的量不必等于血液成分分离装置150的容量。某些实施例中,抽取的血液的量可小于血液成分分离装置150的容量,以至于空气仍存在于分离装置150中。此类实施例中,由于体外容量较低,对象对程序的耐受度更高。另外,如上所述,在血液成分分离装置仍然包含空气时(例如血液成分分离装置150未装满时),本发明的实施例可暂停抽取步骤,将补偿流体输回对象,然后重新开始抽取以填满血液成分分离装置容量中的剩余容量。此外,这使得体外容量最小,并提高对象对程序的耐受度。
然后,如上所述,血液成分分离装置可将抗凝的全血分离成组成成分(步骤640),且可提取一种或多种成分(步骤650)。在此期间,方法可再次将补偿流体输回患者(步骤717)。此外或替代地,如果要通过浪涌淘析提取成分,则技术人员可开始将补偿流体输送至血液成分分离装置150。补偿流体将分离装置中的血浆排出到血浆袋158或废液袋220(图3)。方法可继续此浪涌步骤,直到已知百分率(例如85%)的血浆从分离装置150排出。然后方法可停止血液成分分离装置150,通过回输管路140将分离装置中的内容物(例如剩余的血液成分和补偿流体)输回对象(步骤660)。如参照图6所述的,如果获取/采集到目标量的成分(例如血浆),则结束程序。否则,系统可通过重复步骤620至660用于获取/采集第二批成分。
本发明的某些实施例还可包括回输管路140上的一个或多个压力传感器。这些压力传感器(未示出)测量回输管路140内的压力。测量的压力则可用于确定与接入对象的点处的压力相对应的对象接入压力。然后,本发明的实施例可基于对象接入压力来控制回输管路140内的流动。例如,如果对象接入压力太高,则回输泵142可减小回输管路140内的流动,以降低对象接入压力,并避免给对象造成伤害。
一旦系统将剩余血液成分和补偿流体输回对象,本发明的某些实施例就能确定提取的血液成分(如血浆)的量以及用补偿流体替换的量。此类实施例中,系统可首先计算转筒的平均红血细胞压积和血浆交换百分率。然后,系统可利用此信息来确定提取的血浆量以及用补偿流体代替的血浆量。
应注意的是,系统的所有部件应由与其接触的物质相容的适当材料制成。例如,抽取管路120、回输管路140和管路152、154应与血液和血液成分相容。另外,血小板袋156和血浆袋158应分别与血小板和血浆相容。同样,抗凝血剂管路130应与抗凝血剂相容。
应注意的是,上述实施例中的所有泵的大小和容量不必相同。例如,抽取泵122可比回输泵142和抗凝血剂泵132更大,并具有更大的容量。另外,通过各个管路的流量不必相同。例如,某些实施例中,通过抽取管路120和抽取泵122的流量可大于通过回输泵142与抗凝血剂泵132的流量之和。
重要的是要注意上述的任意实施例可用于各种单采血液成分程序和血液处理程序。例如,实施例可用于单采红血细胞成分、单采血浆成分、单采血小板成分,或各种治疗应用。
尽管以上讨论公开了本发明的各种示例性实施例,但很明显,本领域的技术人员在不背离本发明的真实范围下,可做出实现本发明某些优点的各种修改。

Claims (25)

1.一种用于采集和交换血液成分的非连续血液处理系统,包括:
静脉接入装置,用于从对象抽取全血,并将血液成分输回所述对象;
血液成分分离装置,用于将抽取的血液分离成第一血液成分和第二血液成分,所述血液成分分离装置具有出口并构造成将所述第一血液成分输送至第一血液成分袋,所述血液成分分离装置经由所述血液成分分离装置的同一出口交替排放所述第一血液成分和所述第二血液成分;
血液抽取管路,与所述静脉接入装置流体连接并构造成将抽取的全血输送至所述血液成分分离装置,经过所述血液抽取管路的流动由血液抽取泵控制;
抗凝血剂管路,与抗凝血剂源连接,所述抗凝血剂管路将抗凝血剂引入抽取的全血中,经过所述抗凝血剂管路的流动由抗凝血剂泵控制;以及
回输管路,与所述静脉接入装置和所述血液成分分离装置流体连接,用于将所述第二血液成分输回患者,经过所述回输管路的流动由回输泵控制,其中所述回输管路在所述血液抽取泵与所述静脉接入装置之间的点处与所述静脉接入装置流体连接。
2.根据权利要求1所述的血液处理系统,其中所述血液成分分离装置包括入口与出口分开的双端口离心转筒。
3.根据权利要求1所述的血液处理系统,其中所述第一血液成分是血浆,而所述第二血液成分是红血细胞。
4.根据权利要求1所述的血液处理系统,其中所述第一血液成分是血小板,而所述第二血液成分是血浆。
5.根据权利要求1所述的血液处理系统,其中在靠近所述静脉接入装置处,所述抗凝管路将抗凝血剂引入抽取的血液中。
6.根据权利要求1所述的血液处理系统,其中所述第一血液成分是红血细胞。
7.根据权利要求1所述的血液处理系统,还包括位于所述血液成分分离装置与所述静脉接入装置之间的回输管路上的阀门,所述阀门停止所述回输管路内的流动。
8.根据权利要求1所述的血液处理系统,还包括位于所述回输管路中的血浆贮存器,所述血浆贮存器用于容纳血浆。
9.根据权利要求1所述的血液处理装置,其中所述第一血液成分是血小板。
10.根据权利要求9所述的血液处理系统,其中,除所述第一血液成分和所述第二血液成分以外,所述血液成分分离装置还将抽取的血液分离成第三血液成分。
11.根据权利要求10所述的血液处理装置,其中,除所述第二血液成分以外,还通过所述回输管路将所述第三血液成分输回所述对象。
12.一种采集和交换血液成分的方法,包括:
(a)将静脉接入装置插入对象,所述静脉接入装置与抽取管路、抗凝管路和回输管路连接;
(b)经由所述抽取管路从对象抽取血液,所述抽取管路与所述血液成分分离装置连接,经过所述抽取管路的流动由所述抽取管路泵控制;
(c)经由所述抗凝血剂管路将抗凝血剂引入抽取的血液,经过所述抗凝血剂管路的流动由抗凝血剂管路泵控制;
(d)利用所述血液成分分离装置将所述抽取的血液分离成第一血液成分和第二血液成分;
(e)从所述血液成分分离装置提取所述第一血液成分;
(f)经由所述回输管路将所述第二血液成分输回患者,经过所述回输管路的流动由回输管路泵控制,其中所述回输管路在所述抽取管路泵与所述静脉接入装置之间的点处与所述静脉接入装置流体连接。
13.根据权利要求12所述的方法,其中所述血液成分分离装置是离心转筒。
14.根据权利要求12所述的方法,其中,从所述血液成分分离装置提取第一血液成分包括将补偿流体引入所述血液成分分离装置中,并通过浪涌淘析提取所述第一血液成分。
15.根据权利要求12所述的方法,其中从所述对象抽取的血液量不装满所述血液成分分离装置。
16.根据权利要求12所述的方法,还包括:
(g)在将第二成分输回对象时暂停抽取血液。
17.根据权利要求16所述的方法,还包括重复步骤(a)至(g),直到提取到目标量的第一血液成分。
18.根据权利要求12所述的方法,还包括:
监测所述回输管路内的压力;以及
基于监测到的压力调节所述回输管路内的流体流动,以将压力保持在所需的压力范围内。
19.根据权利要求12所述的方法,还包括在从所述对象抽取一定量的血液之后将一定量的补偿流体输回所述对象。
20.根据权利要求12所述的方法,还包括:
(g)在装满所述血液成分分离装置之前暂停抽取血液;
(h)将一定量的补偿流体输回所述对象;以及
(i)重新开始从所述对象抽取血液。
21.根据权利要求20所述的方法,其中所述补偿流体的量是从所述血液成分分离装置提取的第一血液成分的量的函数。
22.一种用于采集和交换血液成分的血液处理系统,包括:
静脉接入装置,用于从对象抽取全血,并将血液成分输回所述对象;
双端口血液成分分离装置,用于将抽取的血液分离成第一血液成分和第二血液成分,所述血液成分分离装置构造成将所述第一血液成分输送至第一血液成分袋;
血液抽取管路,与所述静脉接入装置流体连接并构造成将抽取的全血输送至所述血液成分分离装置,经过所述血液抽取管路的流动由血液抽取泵控制;
抗凝血剂管路,与抗凝血剂源连接,所述抗凝血剂管路将抗凝血剂引入抽取的全血,经过所述抗凝血剂管路的流动由抗凝血剂泵控制;以及
回输管路,与所述静脉接入装置和所述血液成分分离装置流体连接,用于将所述第二血液成分输回患者,经过所述回输管路的流动由回输泵控制,其中所述回输管路在所述血液抽取泵与所述静脉接入装置之间的点处与所述静脉接入装置流体连接。
23.根据权利要求22所述的血液处理系统,其中所述双端口血液成分分离装置是离心转筒。
24.根据权利要求22所述的血液处理系统,其中所述第一血液成分是血浆,而所述第二血液成分是红血细胞。
25.根据权利要求22所述的血液处理系统,其中所述第一血液成分是血小板,而所述第二血液成分是血浆。
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US9095665B2 (en) 2015-08-04
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