CN112587740A - 用于采集血浆的系统 - Google Patents
用于采集血浆的系统 Download PDFInfo
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- CN112587740A CN112587740A CN202011398284.6A CN202011398284A CN112587740A CN 112587740 A CN112587740 A CN 112587740A CN 202011398284 A CN202011398284 A CN 202011398284A CN 112587740 A CN112587740 A CN 112587740A
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- plasma
- donor
- volume
- blood
- anticoagulant
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Abstract
本发明提供了一种用于采集血浆的系统。提供了一种血浆取出系统和一种用于操作血浆取出系统的方法,通过该血浆取出系统和该用于操作血浆取出系统的方法,对所采集的抗凝血浆的体积/重量进行了优化。在一个示例中,提供了诺模图,该诺模图利用供者的血细胞比容来计算具有由FDA诺模图所允许的最大体积的血浆产品内的原料血浆的体积/重量。在具有多个采集阶段——在所述多个采集阶段后为再输注循环,在该再输注循环中,浓缩红细胞返回至供者——的血浆取出过程中,在每个采集循环开始之前计算待采集的血浆产品的体积以考虑供者的增大的血细胞比容,从而导致在该血浆取出过程期间待采集的血浆产品的总体积更大。
Description
本申请是申请日为2019年5月21日、申请号为201980031598.1(PCT/US2019/033318)、发明名称为“用于对血浆采集体积进行优化的系统和方法”的发明专利申请的分案申请。
技术领域
本申请涉及用于进行血浆取出(plasmapheresis)的系统和方法,并且更具体地涉及其中对能够从特定供者采集的源血浆或原料血浆产品的体积进行优化的血浆取出系统和方法。
背景技术
血浆取出是一种单采过程(apheresis procedure),在该单采过程中,从供者抽取全血,将血浆与细胞血液组分(红细胞、血小板和白细胞)分离并保留,然后将细胞血液组分返回至供者。血浆与细胞组分的分离通常通过离心或隔膜过滤在自动的过程中完成。
在自动的血浆取出中,从供者抽吸全血,将全血与抗凝剂(“AC”)以特定的比率混合,然后将全血分离成抗凝血浆以及红细胞和其他细胞组分。一旦如由与血浆采集容器相关联的重量秤所确定的那样已采集到目标体积的抗凝血浆(或“血浆产品”),就停止从供者抽取全血,并将红细胞和其他细胞组分返回至供者。通常,在多个采集与再输注循环中采集血浆产品,直到已采集到总目标体积的抗凝血浆为止。该抗凝血浆用于之后的输血或进一步生产。
被采集以用作用于进一步生产的源材料的血浆(“源血浆”)被从多个供者采集并为此目的而被组合或合并在一起。FDA针对注册的血液采集中心发布了有关在血浆取出期间可以被采集作为源血浆的血浆的体积的指南,以便提高用于制作源血浆的过程的一致性并且使人员错误的机会最小化。(FDA规定:“体积限制-源血浆的自动采集(Volume Limits-Automated Collection of Source Plasma)(11/4/92)”)。该FDA规定提到了因使用的各种类型的抗凝剂溶液、不同浓度的抗凝剂以及不同范围的抗凝剂与血浆的比率而造成的不一致性。
该FDA规定给出了简化的血浆体积诺模图,其再现于图1中所示的图表中,其中,可以从特定供者采集的血浆的体积(或重量)受到限制,以确保供者的安全性和舒适性。更具体地,FDA诺模图基于供者的重量来限制血浆的体积(或重量),并建立了抗凝剂的体积,抗凝剂可以以抗凝剂比抗凝血液为1:16的比率添加或者以0.06份抗凝剂比1份抗凝血液的方式添加,以达到对于特定供者而言的作为血浆加抗凝剂的总和的最大采集体积。
FDA规定中给出的简化诺模图是用于对被血液采集中心使用的血浆产品采集体积进行确定的主要方法。因此,通常将在此类中心使用的血浆取出设备编程为根据由FDA诺模图所允许的最大采集体积来采集特定体积/重量的抗凝血浆(假定密度已知),其中,抗凝剂被以1:16或0.06的比率添加至全血。
FDA诺模图中进行的一种简化是在确定血浆产品的采集体积时不考虑供者血细胞比容。然而,血浆产品中原料血浆与抗凝剂的相对比例取决于供者的血细胞比容以及AC与供者的全血组合的比率。结果,较高血细胞比容的供者在达到可以从该供者安全地采集的最大(原料)血浆体积之前达到了FDA诺模图中给出的最大采集体积。这造成了血浆采集中心的低效,因为所采集的原料血浆的体积小于可能的最大量。
此外,可以从供者安全地采集的血浆的量可能还取决于除了供者的重量和红细胞比容以外的因素,比如供者的身高、性别和年龄,因为这些因素影响供者的总血液体积(和血浆的体积)。
由于来自多个供者的源血浆被组合,因此使从每个单独的供者采集的血浆体积最大化非常重要,因为从每个单独的供者采集的体积即使有很小的增加,当被添加在一起时,也会导致合并血浆的总体积的有意义的增加。如果血浆取出设备能够更好地为原料血浆体积设目标,则可以从每个供者采集到更多血浆蛋白,从而提高血浆采集中心的整体效率。因此,通过本公开,提供了与供者安全性和舒适性相一致的用于对采集的血浆的体积进行优化的系统和方法。
发明内容
通过本公开,提供了一种用于操作血浆取出系统以采集一定体积的抗凝血浆体积(即,血浆产品)的方法,该方法确保血浆产品中的原料血浆的总体积是无论是供者的独特身体特征所指示的、还是由FDA诺模图或某些其他方法所指示的可以从特定供者采集的与供者的安全性和舒适性相一致的最大值。
根据本公开的第一方面,提供了一种用于操作血浆取出系统以采集血浆产品体积的方法,该血浆产品体积包括根据FDA诺模图中基于供者的重量给出的限制的原料血浆的最大可允许体积/重量。
为了采集由FDA诺模图所允许的最大体积/重量的原料血浆,提供了一种修改的诺模图,该修改的诺模图利用供者的血细胞比容来计算血浆产品的目标体积/重量,该血浆产品具有由FDA诺模图所允许的原料血浆的最大体积。将原料血浆的计算体积/重量与由FDA诺模图所允许的原料血浆的最大体积/重量进行比较。如果原料血浆的计算体积/重量小于最大允许体积/重量,则将待采集的血浆产品的体积/重量从由FDA诺模图针对该血浆产品所允许的最大体积/重量上调下述量:该量等于差值加为处理额外体积/重量的血浆而添加的抗凝剂的额外量。
因此,在已知供者的血细胞比容和仪器的AC比率的情况下,确定可以从供者安全采集的与FDA诺模图中给出的限制相一致的额外原料血浆的体积,然后基于FDA诺模图中给出的供者的重量而对待采集的血浆产品的总体积/重量进行相应调整。
通常,血浆取出过程包括交替阶段的连续循环,这些交替阶段中的一个阶段是从供者抽取全血,然后分离并采集血浆,这些交替阶段中的另一阶段是将分离的红细胞和任何其他非RBC细胞组分返回至供者。供者的血细胞比容在血浆取出过程中将发生变化,从而从一个循环至下一循环影响所采集的血浆产品中的抗凝剂的量。
因此,在本公开的第一方面中,在开始随后的抽取/分离阶段之前确定供者的新的血细胞比容值,并在开始每次抽取/分离阶段之前重新计算针对该过程的血浆产品的目标体积/重量,以确保采集到由FDA诺模图所允许的原料血浆的最大量。
根据第二方面,提供了用于在单采过程期间采集一定量的血浆的另一方法。该方法的步骤包括:确定供者的总全血体积Vb;基于Vb确定可以从供者采集的原料血浆的体积VRP;基于为该过程建立的抗凝剂比率(ACR,定义为对于不具有抗凝剂的供者血液而言供者血液体积与抗凝剂体积的比率)以及供者的Hct来确定待采集的血浆产品的目标体积VPP,其中,VPP等于待采集的原料血浆的体积VRP加在单采过程期间添加至VRP的抗凝剂VAC的体积,使得VPP=VRP*K,其中,K=(ACR*(1-Hct/100)+1)/(ACR*(1-Hct/100));从供者抽取全血;将抗凝剂以与ACR一致的量添加至全血;从全血分离血浆产品;以及将血浆产品传送至采集容器,直到采集容器中的血浆产品的体积达到VPP为止。由于血浆取出过程包括多个抽取/分离及返回阶段,因此将在每个抽取/分离阶段开始之前基于在开始每个抽吸阶段之前所确定的供者的血细胞比容的值来重新计算针对该过程的VPP,并相应地调整血浆产品的目标体积。替代性地,可以基于供者的总血浆体积的计算值——该计算值是基于Vb和供者的血细胞比容计算的——确定VRP。
在第三方面,提供了一种用于确定在单采过程期间可以采集的血浆产品的体积VPP的方法,其中,VPP等于可以采集的原料血浆的体积VRP加在单采过程期间添加至VRP的抗凝剂的体积VAC。该方法的步骤包括:确定供者的重量Wkg和性别M或F;确定供者的血细胞比容Hct;基于供者的重量Wkg和性别M或F确定可以采集的原料血浆的体积VRP;基于抗凝剂比率ACR和供者的Hct确定VPP与VRP之间的比率K,使得K=VPP/VRP;确定VPP,使得VPP=VRP*K。此外,K=(ACR*(1-Hct/100)+1)/(ACR*(1-Hct/100))。在VPP确定后,从供者抽取全血;将抗凝剂以与ACR一致的量添加至全血;从全血分离血浆产品;以及,将血浆产品传送至采集容器。在已从供者抽取到期望量的全血后,将红细胞返回至供者。然后,在每个抽吸阶段之前确定供者的Hct和VPP。
在相关方面,重复抽吸和分离步骤,直到采集容器中的血浆产品的体积达到VPP为止。
在相关方面,可以通过体积平衡来计算在第一采集阶段之后的供者的血细胞比容,假设在每个抽吸循环开始时供者的红细胞的数量是相同的,而血液的总体积从一个循环到下一循环以与所采集的原料血浆的量相等的量减少。替代性地,在每个抽吸循环开始时的供者的血细胞比容可以通过光学传感器或其他传感器来测量。
在另一方面,可以从特定供者采集的原料血浆的体积可以通过几种不同方式中的任一种方式来确定。这些方式例如包括:FDA诺模图,其仅考虑供者的重量;修改后的FDA诺模图,其进一步考虑了供者的血细胞比容,并考虑了为特定供者所计算的总血液体积或总血浆体积的部分。总血液体积或总血浆体积例如可以使用下述各者确定:Nadler等式、Gilcher五分法、国际血液学标准化理事会(ICSH)提供的表格或者使用供者的身高、重量、性别和年龄的符合供者的安全性和舒适性的任何其他普遍接受的方法。
在第四方面,提供了一种用于从全血分离血浆的自动系统,该自动系统包括可重复使用的硬件部件和一次性套件。一次性套件还包括:i)用于将全血分离成血浆部分和浓缩细胞部分的分离器,该分离器具有输入端、血浆输出端口和浓缩细胞出口端口,该输入端具有一体地连接至输入端的用于将全血从供者传送至分离器的血液管线,该血浆输出端口通过血浆管线一体地连接至血浆采集容器,该浓缩细胞出口端口一体地连接至储存器,该储存器用于在再输注至供者之前接纳浓缩细胞;ii)终止于静脉穿刺针的供者管线,该供者管线用于将全血从供者传送至血液管线;iii)抗凝剂管线,该抗凝剂管线一体地连接至血液管线并构造成连接至抗凝剂源,该抗凝剂管线用于将抗凝剂传送至供者管线;以及iv)再输注管线,该再输注管线用于将浓缩细胞从储存器传送至供者管线。
可重复使用的硬件部件还包括:i)蠕动式第一泵,用于在采集阶段期间将抗凝剂以受控的速率输送到血液管线中;ii)第二泵,用于在采集阶段期间将抗凝全血输送至分离器以及在再输注阶段期间使浓缩细胞组分返回;iii)第三泵,用于在采集阶段期间将浓缩细胞组分从分离器输送至储存器;iv)与血液管线、血浆管线和再输注管线中的每一者相关联的夹具;v)用于对血浆采集容器、储存器所述抗凝剂源中的每一者进行称量的重量秤;以及vi)包括触摸屏的可编程控制器,该触摸屏用于接收来自操作者的输入,该可编程控制器配置成接收来自重量秤中的每个重量秤的信号并自动操作第一泵、第二泵和第三泵及夹具,以在采集阶段期间将全血分离成血浆部分和浓缩细胞部分以及在再输注阶段期间将浓缩细胞返回至供者。可编程控制器还配置成根据本文中描述的方法中的任一方法来确定待采集在血浆采集容器中的血浆产品的目标量,并且可编程控制器配置成在接收到关于血浆采集容器中的血浆产品的量等于由控制器确定的血浆产品的目标量的信号时终止采集阶段。在对待采集的血浆产品的目标量进行确定时,控制器可以配置成在每个循环的采集阶段之前计算供者的血细胞比容。替代性地或附加地,控制器可以接收来自传感器等的指示供者的血细胞比容的信号。此外,血浆采集容器中的血浆产品的量可以由例如与血浆采集容器相关联的重量秤或直接测量体积的光学传感器确定。
附图说明
图1是示出了FDA规定“体积限制—源血浆的自动采集(11/4/92)”中提出的简化诺模图的表格。
图2是适用于本申请的系统和方法的示例性血浆取出仪器的立体图。
图3是能够与图2的血浆取出系统一起使用的结合在一次性套件中的类型的转动隔膜分离器的其中部分被剖开以示出细节的立体图。
图4是图2的血浆取出系统的前部面板的立体图,其示出了安装至该前部面板的一次性套件的各部件。
图5是示出了血浆取出系统在采集阶段中的操作的示意图。
图6是示出了血浆取出系统在再输注阶段中的操作的示意图。
图7是示出了基于供者血细胞比容的原料血浆的体积的表格,该原料血浆包含在使用抗凝剂与全血的比率为16:1的由FDA诺模图所设定的血浆产品体积极限内。
图8是示出了基于图7中列出的值与基于FDA诺模图可以采集的原料血浆的最大体积之间的差的血浆产品中“未要求的(unclaimed)”原料血浆的体积的表格。
图9是示出了基于供者的重量和血细胞比容可以从供者采集的将导致由FDA诺模图所允许的原料血浆的最大可允许体积的血浆产品的体积的表格。
图10是示出了根据本申请的对用于执行假设的血浆取出过程的可编程控制器的输入的表格。
图11a、图11b包括分为两个部分的表格,图示了如何基于图10的表格中的输入而在假设的血浆取出过程中增大供者的血细胞比容,并导致为了采集目标体积的血浆原料所必需的血浆产品的总采集体积的增加。
图12是图示了IgG在血浆取出期间的稀释的图。
具体实施方式
下面将阐述对根据本公开的系统和方法的更详细描述。应当理解,下面对特定设备和方法的描述意在为示例性的,而非穷尽所有可能的变型或应用。因此,本公开的范围不意在是限制性的并且应被理解为涵盖普通技术人员将想到的变型或实施方式。
在本申请的上下文中,血浆取出在包括总体上指示为10的硬件部件和总体上指示为12的一次性套件的自动系统上进行,以采集待作为源血浆被处理的血浆。参照图2至图6并且如下面更详细地描述的,一次性套件12由一体地连接的分离器、容器以及用以在无菌流体路径内运输血液和溶液的管道组成。
在图3中最佳示出的分离器14具有转动隔膜过滤器16,该转动隔膜过滤器16安装至转子18以便在壳体20内旋转,以将血液分离成各组分。对转动隔膜分离器的详细描述可以在授予Schoendorfer的美国专利No.5,194,145中找到,该美国专利通过参引并入本文中。如可以理解的,在不同的系统中,全血的分离可以通过离心来完成。参见例如授予Williamson等人的US 5,360,542。
在血浆取出期间,抗凝全血穿过全血输入端口22进入分离器14。血浆由转动隔膜过滤器分离,然后从血浆输出端口24流出,穿过血浆管线26,并进入血浆采集容器28。浓缩细胞从浓缩细胞输出端口30被泵出到储存器32中,细胞保留在储存器32中直到再输注给供者为止。
一次性套件12还包括下述管道线路:用于在采集期间将来自供者的全血引入到系统中并在再输注期间将浓缩细胞返回至供者的管线(供者管线34,该供者管线34终止于静脉穿刺针36)、以及用于将抗凝全血传送至分离器的管线(血液管线38)、用于将浓缩细胞传送到储存器中的管线(细胞管线40)、用于将浓缩细胞从储存器传送到供者管线中的管线(再输注管线42)、用于将血浆传送到血浆采集容器的管线(血浆管线44)、用于生理盐水的管线(生理盐水管线46)和用于抗凝剂的管线(AC管线48)。
硬件部件10包括可编程控制器50和具有图形用户界面(“GUI”)的触摸屏52,操作者通过触摸屏52来控制血浆取出过程。例如,GUI允许输入下述各者中的任一者:供者ID、供者性别、供者身高、供者重量、供者年龄、供者血细胞比容/血红蛋白;目标生理盐水输注体积(如果选择了生理盐水方案的话)和目标血浆体积。触摸屏52还使操作者能够收集状态信息并处理错误情况。
在硬件部件10的前部面板上定位有三个蠕动泵,这三个蠕动泵包括AC泵54、血液泵56和细胞泵58。当全血从供者进入套件时,AC泵54将抗凝剂溶液(AC)以受控的速率输送到血液管线38中。血液泵56在血浆取出过程的采集阶段期间将抗凝全血输送至分离器,并在血浆取出过程的再输注阶段期间将浓缩细胞组分返回至供者并且如果需要的话将替代流体返回至供者。细胞泵58在采集阶段期间将浓缩细胞组分从分离器14输送至存储器。
前部面板还包括四个夹具,一次性套件12安装到这四个夹具中,这四个夹具包括再输注夹具60、血液夹具62、生理盐水夹具64和血浆夹具66。再输注夹具60在采集阶段期间(图5)闭合以阻塞再输注管线(42),并在再输注阶段(图6)打开以允许血液泵将浓缩细胞组分从储存器32再输注至供者。血液夹具62在采集阶段期间打开以允许抗凝全血被泵送至分离器14并在再输注阶段期间闭合以阻塞血液管线38。生理盐水夹具64在采集阶段期间并在经分离的细胞组分的再输注期间闭合以阻塞生理盐水管线46。如果将生理盐水用作替代流体,则生理盐水夹具64在再输注阶段期间打开。血浆夹具66在采集阶段期间打开以允许血浆流入到血浆采集容器28中并在再输注阶段期间闭合。
硬件部件10包括三个重量秤,以监测当前血浆采集体积(秤68)、AC溶液体积(秤70)和浓缩细胞成分体积(秤72)。该系统还包括各种传感器和检测器,包括静脉压力传感器74、分离器压力传感器76、光学血液检测器78和空气检测器80。
供者在整个过程中都连接至系统。如所图示的,一次性套件12包括单个静脉穿刺针36,在采集阶段(图5)通过该静脉穿刺针36从供者抽取全血,并且在再输注阶段(图6)通过该静脉穿刺针36使浓缩细胞返回至供者。如上面提到的,血浆取出过程可以包括多个循环,每个循环具有采集/分离阶段,随后为返回或再输注阶段。在采集阶段期间,全血被分离成血浆和浓缩细胞。一次性套件包括用于接纳经分离的血浆的血浆采集容器28和用于接纳浓缩细胞的储存器32。在再输注阶段期间,来自储存器32的浓缩细胞通过静脉穿刺针36被再输注至供者。通常,利用单个静脉穿刺针36进行血浆取出涉及多个采集与再输注循环。
返回至图5,在采集阶段期间,抗凝溶液(AC)被以受控的速率泵送并在其进入一次性套件12时与全血混合。抗凝血液被泵送至分离器14,在分离器14中,血浆与细胞组分分离并被导向至血浆采集容器28。
细胞组分从分离器14被泵送至储存器32。当储存器32达到浓缩细胞的预期体积时或者如果已经达到目标的血浆采集体积,采集阶段停止。
然后,再输注阶段开始。参照图6,在再输注阶段期间,血液泵56反转方向并将浓缩细胞从储存器32通过单采针36泵送回供者。如果选择了生理盐水方案,根据该方案,生理盐水作为对采集到的血浆的替代流体返回至供者,在最后的再输注阶段之后进行生理盐水输注。
根据本公开的一个方面,自动血浆采集设备构造成采集一定体积/重量的抗凝血浆(即,血浆产品),该抗凝血浆具有在FDA诺模图中给出的限制下供者所允许的最大体积/重量的原料血浆。为了使包含血浆产品的原料血浆的体积最大化,利用考虑供者血细胞比容的诺模图对设备进行编程。在已知供者的血细胞比容和仪器的AC比率的情况下,可以将待采集的血浆产品的总体积/重量确定成使得血浆产品包括可以从供者采集的与FDA诺模图中给出的对原料血浆的总体积/重量的限制相一致的最大体积/重量的血浆原料部分。通过将计算法编程到控制器中,与离线计算采集体积然后将该采集体积输入到仪器中相比,减小了操作者出错的可能性。
在血浆取出期间,当抗凝剂在从供者抽取全血的同时与全血混合时,抗凝剂均匀地分布在血液中的原料血浆中。然而,全血中的原料血浆的量取决于全血的血细胞比容Hct。建立了以下关系:
RBC的体积=全血的体积*Hct/100。[1]
原料血浆的体积=全血的体积*(1-Hct/100)。[2]
当将抗凝剂与全血混合时,通常以16份全血与1份AC或以1份全血与0.06份AC的AC比率ACR来对抗凝剂进行计量。
ACR=全血的体积/抗凝剂的体积(供者血液无抗凝剂)。[3]
(这产生了与FDA诺模图略有不同的结果,如上面提到的,FDA诺模图将可以添加的抗凝剂的体积标准化为:抗凝剂与抗凝血液的比率为1:16,或0.06份抗凝剂与1份抗凝血液。)
抗凝血液的体积=抗凝剂的体积+全血的体积。[4]
结合等式得出:
原料血浆的体积=ACR*抗凝剂的体积*(1-Hct/100)。[5]
由于红细胞被返还给供者:
采集血浆的体积=原料血浆的体积+抗凝剂的体积。[6]
可以将等式[5]和[6]结合以计算在给定量的采集血浆中的抗凝剂的量:
抗凝剂的体积=采集血浆的体积/(1+ACR*(1-Hct/100))。[7]
此外:
采集血浆的体积=原料血浆的体积*K,其中,K=(ACR*(1-Hct/100)+1)/(ACR*(1-Hct/100))。[8]
考虑到以上等式中表达的关系,可以基于供者的血细胞比容确定在FDA诺模图下所允许的体积的血浆产品内所包含的原料血浆的体积。这种计算的结果在图7中给出,图7示出了基于供者血细胞比容的包含在由FDA诺模图设定的血浆产品体积限制内的原料血浆的体积。
如参照图7可以理解的,对于重量为从110磅至149磅的供者(对于这类供者,根据FDA诺模图的最大血浆产品体积为690mL)而言,如果供者的血细胞比容为42或更大,则采集的原料血浆的体积小于由FDA诺模图所允许的625mL。对于具有的重量为150磅至174磅的供者(对于这类供者,根据FDA诺模图的最大血浆采集体积为825mL)并且对于具有的重量为175磅以上的供者(对于这类供者,根据FDA诺模图的最大血浆采集体积为880mL)而言,当供者的血细胞比容为40或更大时,情况是类似的。
图8中给出的表格基于图7中给出的值与基于FDA诺模图可以采集的原料血浆的最大体积之间的差呈现了血浆产品中“未要求的”原料血浆的体积。因此,如图9中给出的表格中所示,从任何特定供者采集的血浆产品可以根据FDA诺模图中给出的血浆产品以下述量进行调整:该量与图8中给出的“未要求的”原料血浆的量加处理额外体积所需的抗凝剂的量相对应。
替代性地,可以通过下述步骤来计算待采集的血浆产品的体积:首先,确定供者的重量和血细胞比容Hct;基于供者的重量Wkg确定可以采集的原料血浆VRP的体积;基于抗凝剂比率(ACR;根据FDA诺模图为1:16或0.06:1)和供者的Hct确定VPP与VRP之间的比率K,使得K=VPP/VRP;以及确定VPP,使得VPP=VRP*K。此外,K=(ACR*(1-Hct/100)+1)/(ACR*(1-Hct/100))。
在另一替代方案中,可以通过下述步骤来计算待采集的血浆产品的体积VPP:首先,确定供者的重量Wkg和血细胞比容Hct;基于供者的重量Wkg确定可以采集的原料血浆VRP的体积;基于抗凝剂比率(ACR;根据FDA诺模图为1:16或0.06:1)和供者的血细胞比容确定待添加的抗凝剂的体积VAC,使得VAC=VRP*(ACR*(1-Hct/100));以及确定采集体积,使得VPP=VRP+VAC。
可以使用各种方法来确定基于供者的重量可以采集的原料血浆的体积。例如,可以将供者的重量乘以建立的常数“K1”(比如10mL/kg)。替代性地,可以将供者的重量分为重量类别,为每个类别建立固定的体积(如上面讨论的FDA诺模图中那样,在FDA诺模图中,供者重量的范围被分为三个类别)。
替代性地,可以基于供者的总血液体积来估算供者的血浆体积,并且可以基于该估算来获取与供者的安全性和舒适性相一致的体积的血浆。通常使用利用供者参数的方法来估算供者的总血液体积。这种方法的示例包括Nadler等式(其考虑供者的身高、性别和重量)、Gilcher五分法(其考虑性别、重量和体型(肥胖、消瘦、正常或健壮)、或者国际血液学标准化委员会(“ICSH”)的如在Br.J.Haem.1995,89:748-56中所给出的标准(其考虑供者的身高、重量、年龄和性别)。也可以使用任何其他普遍接受的方法来确定供者的总血液体积。一旦确定了供者的总血液体积,就可以通过将总血液体积乘以常数“K2”来估算供者的血浆体积,其中,“K2”等于(1-供者的Hct)。
根据对2015至2016年National Health and Nutrition Examination Survey(美国国家健康与营养调查)中的人口统计、检查和实验数据进行的分析——其中,性别、年龄、身高、重量、妊娠数据和血细胞比容被提取并被呈现在Pearson等人的发表于BritishJ.Haematology(英国血液学杂志),89:748-756(1995)的Interpretation of measuredred cell mass and plasma volume in adults:Expert Panel on Radionuclides ofthe International Council for Standardization in Haematology(对成人中测得的红细胞质量和血浆体积的解释:国际血液学标准化理事会放射性核素专家小组)中(基于分析得出了ICSH推荐的公式),已经确定的是,对于具有某些特征的供者(即,具有高血细胞比容的低重量女性),在遵守现行法规的同时可以采集多达36%的可用血浆。已经例行实施了对此类供者的血浆取出过程而无不良反应,因此认为这些血浆取出过程是安全的。这表明,在血浆取出过程中可以安全地采集供者的多达36%的可用血浆。
考虑到只有供者的真实血液体积与预测/计算的总血液体积的负偏差会带来潜在风险,那么将血浆的可获取体积进一步下调会是适当的。基于对如在上面引用的Pearson等人所确定的计算血液体积与在Retzlaff等人的发表于J.Haematology(英国血液学杂志)33,5:649-667(1969)的Erythrocyte Volume,Plasma Volume,and Lean Body Mass inAdult Men and Women(成年男性和女性的红细胞体积、血浆体积和瘦重量)中呈现的实验性血液体积数据之间的偏差的考虑,存在95%的可信度的是:个体的预测血液体积将相差不超过20.5%。因此,可以采用0.795的比例因子对上面描述的占供者的总血浆体积的36%的可获取原料血浆进行确定,使得可以与供者的安全性和舒适性相一致地获取供者的计算体积的原始血浆的28.6%。
替代性地,可以在计算可获取血浆的体积VRP之前对计算出的全血的体积VWB进行调整VC,如此,VRP=0.36(1-Hct)(VWB-VC)。对由Retzlaff提供的数据进行回归分析,结果确定出VC=523mL。
因此,采集体积(血浆产品的体积)是基于可以从特定供者采集的原料血浆的体积、供者的血细胞比容和固定的抗凝剂比率ACR确定的。因此,该方法允许对供者的作为与供者安全性最相关的变量的原料血浆体积进行更一致的控制。
在实践中,操作者基于可以被获取的原料血浆的目标体积将针对特定供者的血浆产品的采集体积输入到系统控制器中。目标血浆采集体积可以是基于供者的重量和初始采集阶段的血细胞比容或通过上面给出的其他方法中的任一方法而在图9中所给出的。替代性地,控制器配置成:对于初始采集阶段,在操作者输入由为了确定供者的总血液体积、总血浆体积以及可以被采集的可获取血浆的目标体积而使用的方法所需要的例如供者的重量和血细胞比容和/或任何另外的供者特定信息(比如供者的性别、身高和年龄)时,根据诸如上面描述的那些方法的方法来计算目标血浆产品采集体积。在另一替代方案中,血浆采集设备可以与供者管理系统一体地结合,用于资格筛选的供者参数(比如重量、血细胞比容等)可以通过供者管理系统以电子方式发送至仪器,从而消除了操作者在输入供者参数上出错的机会。供者管理系统还可以利用供者筛选测量值以及原料血浆体积与采集体积之间的关系来自动计算血浆采集体积,该血浆采集体积将传送至血浆取出设备的控制器。
如上面所提到的,血浆取出过程以多个循环的采集/抽吸阶段及返回/再输注阶段来执行。如果返回/再输注阶段不包括对替代流体的再输注,则供者的血细胞比容从一个循环至下一循环将会增加。因此,如果仅基于供者的初始血细胞比容确定血浆产品的目标体积而未考虑供者的血细胞比容增加,则血浆产品中抗凝剂的体积将比通过用于确定血浆产品的目标体积的初步计算所预测的结果更大(而原料血浆的体积将更小)。因此,为了确保所采集的血浆产品的体积包含已确定要从特定供者获取的原料血浆的最大体积,贯穿血浆取出过程定期重新计算血浆产品的目标体积、比如在每个循环的采集阶段开始之前重新计算血浆产品的目标体积,以将供者血细胞比容的变化纳入考虑。
因此,基于供者的起始血细胞比容对血浆产品的目标体积进行确定。血浆取出过程从第一抽吸阶段开始,直到已从供者抽取到指定体积的全血(通常为约500mL)为止。将抗凝剂添加至全血,并将抗凝全血分离成血浆产品、红细胞和其他非RBC血液组分。在第一抽吸阶段结束时,红细胞和非RBC血液组分返回至供者。在第一抽吸阶段之后采集的血浆产品的当前体积例如由重量秤确定。然后,建立供者的血细胞比容的当前值,并确定待采集的血浆产品的新目标体积,并且执行抽取阶段和返回阶段的第二循环。重复抽吸阶段和返回阶段的循环,直到采集到对于该血浆取出过程的如在每个抽吸阶段开始之前重新计算的目标体积的血浆产品。在最后的采集阶段之后,控制器启动最后的红细胞再输注阶段,此后,供者断开连接。
参照图10和图11a、图11b的表格,可以看出根据上面给出的方法执行具有多个采集/再输注循环的血浆取出过程的益处。图10显示了对重量为190磅(86.4kg)并且具有的初始血细胞比容为44的供者进行的假设血浆取出过程的输入数据。参考图1的表格,简化的FDA诺模图将待从这类供者采集的血浆的体积限制为800mL,并且将血浆产品的总采集体积限制为880mL。在本示例中,FDA诺模图对可以采集的原料血浆的体积的限制仅是出于说明的目的。如上面给出的,可以使用其他方法来确定可以从供者安全地抽取的原料血浆的量,该原料血浆的量与FDA诺模图所指示的量不同。
血浆取出过程中的采集及再输注循环的数目可以在从三至十二的范围内。在假设的血浆取出过程中,有五个采集及再输注循环,选择五个采集及再输注循环是出于说明的目的。
在第一采集循环开始之前,基于供者的初始血细胞比容根据上面描述的方法确定待采集的原料血浆的体积和待采集的血浆产品的总目标体积。如表格的第一行(循环1开始)中给出的,待采集的血浆产品的初始目标体积为889mL,这与由图9的表格针对重量为175磅以上且血细胞比容为44的供者所指示的相同,以便从供者获取FDA限制的800mL的原料血浆。
在每个采集阶段期间,从供者中抽吸500mL的全血,并将抗凝剂以预定比率(即,1:16)添加至全血,使得对于500mL的每个采集循环添加31mL。全血加抗凝剂被分离成血浆部分和红细胞部分。
在第一返回阶段期间(循环1返回结束),红细胞和“非RBC”血液组分返回至供者,使得供者的血细胞比容在第一返回循环结束时增加至45.6%,这是由控制器基于下述事实而计算的:血液体积被减少了所采集的原料血浆的量,而总血液体积中的红细胞数量仍与血浆取出过程开始时相同。当确定用于下一循环的新的血细胞比容值时,控制器还可以考虑在每个返回阶段随红细胞一起再输注的抗凝剂的体积以及在循环2及之后抽吸到的供者全血中的残留抗凝剂。然后,基于供者的原料血浆体积以及新的增加的血细胞比容重新计算对于该过程待采集的原料血浆体积和血浆产品的总目标体积。这提供的新的目标采集体积为891mL。
然后执行第二采集阶段,致使在前两个采集阶段(循环2抽吸结束)采集了总共430mL的包含386mL的原料血浆的血浆产品。红细胞和“非RBC”血液组分再次返回至供者,此后,供者的血细胞比容被计算为47.2%。
再执行两个500mL的采集阶段,每个阶段之后是返回阶段,其中,在每个采集阶段开始之前确定针对待采集的原料血浆的体积和血浆产品的总体积的新的值。随着供者的血细胞比容增加,针对该过程重新计算的目标采集体积增加至893mL(对于第三采集阶段),然后增加至894mL(对于第四采集阶段)。进行第五“微”采集循环,以使采集的原料血浆的体积达到由FDA诺模图针对假设供者所允许的800mL。重新计算的针对第五采集阶段的血浆产品的目标采集体积保持在894mL。
因此,如以上示例中所示,当针对每个采集阶段重新计算对于血浆产品的目标采集体积时,得到对于血浆产品的目标采集体积为894mL,这是为了采集到800mL的目标体积的原料血浆所需的。相比之下,如果目标采集体积仅基于供者的初始血细胞比容来确定,则将采集889mL的血浆产品;或者,如果目标采集体积是基于简化的FDA诺模图,则将采集880mL的血浆产品。在这两种情况下,都将采集到小于800mL的目标体积。
如可以理解的是,在过程之前和在过程期间可以确定的供者的血细胞比容的准确性越高,则采集到的血浆产品的目标体积就越可能包括对于特定供者可以采集的原料血浆的最大体积。如上面所描述的,供者在过程期间的血细胞比容基于以下假设:在每个抽吸循环中抽取的100%的红细胞随100%的非RBC细胞产品和一定体积的抗凝剂一起在每个返回循环中被再输注。然而,已经确定的是,在血液分离过程期间,间隙液会转移至血管内空间,从而将抽取体积的一半恢复。参见Saito等人的发表于Transfusion(输血)2013;53(11):2744-50的Interstitial fluid shifts to plasma compartment during blooddonation(在献血期间转移至血浆腔室的间隙液)。在每个返回阶段,除了红细胞、非RBC细胞产品和抗凝剂之外,转移后的间隙液也被再输注。因此,考虑到间隙液的转移将导致更准确地确定血细胞比容,并因此更精确地确定血浆产品的目标体积,这将得出原料血浆的最大量。
间隙液在血浆取出期间的转移已经通过在血浆取出过程中追踪供者的免疫球蛋白G(IgG)的水平而证实。例如参见Burkhardt等的发表在Transfusion(输血)2017;56:417-420的Immunoglobulin G levels during collection of large volume plasma forfractionation(在采集大体积血浆以用于分离期间免疫球蛋白G的水平)。如果没有间隙液转移,供者的IgG水平将在血浆取出过程中保持稳定。然而,IgG水平已被表明为下降,并且IgG水平下降的量是已经转移至血液系统的间隙液的体积的函数。
参照图12,示出了依据实验而形成的采集血浆的体积(沿X轴)相对于IgG浓度(沿Y轴)的曲线。可以看出,从零采集血浆的基线(在过程开始时)至200mL的采集血浆,供者的IgG下降了9%,并且从200mL的采集血浆至800mL的采集血浆,供者的IgG下降了另外4%。这能够归因于:间隙液的转移等于供者的初始总血液体积的约9%(在200mL的血浆被采集后)至供者的初始总血液体积的约13%(在800mL的血浆被采集后)。
基于图12的曲线,已经建立了供者的IgG浓度的量与采集血浆的体积之间的以下关系:y=1.0017x-0.02,其中,y=IgG浓度,并且x=采集血浆体积。因此,供者的血液体积的通过间隙液的转移所替代的比例等于Vb(1-y),其中,Vb是供者的全血的初始体积。因此,可以基于采集血浆的体积来计算间隙液的转移体积,并且可以在每个返回阶段中将该量添加至再输注的红细胞、非RBC细胞产品和抗凝剂的体积中,以确定供者的当前总血液体积并因此确定血细胞比容。如可以理解的,控制器可以配置成基于采集血浆的体积自动确定已经转移的间隙液的体积,并且在每个抽吸阶段之前确定供者的血细胞比容时将该转移的体积包括在内。
替代性地,可以采用直接测量供者的血细胞比容的其他方法比如光学传感器,或者,如果使用离心分离器,则测量离心机中红细胞的体积。
另外,通常在血浆取出过程开始之前在预处理步骤中将抗凝剂引入到一次性套件中,比如用于对一次性套件进行预注,从而执行一个或更多个预循环或用于执行其他预过程步骤。就用于这些目的的抗凝剂最终将被直接导向至血浆产品采集容器而言,在对血浆采集容器中所含的体积——该体积导致目标体积的所采集原料血浆——进行确定时可以对用于这些目的的抗凝剂加以考虑。例如,这可以通过测量“装满”抗凝剂的容器的重量和第一抽吸循环开始之前的抗凝剂的容器的重量并将抗凝剂的体积添加至血浆产品的目标体积来完成。控制器可以配置成自动执行对考虑与抗凝血浆分开地被引入到血浆采集容器中的抗凝剂而言所必须的步骤。
上面阐述的方法和系统具有几个方面。在第一方面,提供了一种用于采集血浆的方法,其中,在多个采集阶段中采集血浆产品,在所述多个采集阶段之间,将分离的红细胞再输注至供者。该第一方面的方法包括:a)确定供者的全血的体积Vb和血细胞比容Hct;b)确定可以从供者采集的原料血浆的体积VRP;c)确定可以采集的血浆产品的体积VPP,其中,血浆产品包括原料血浆的体积加抗凝剂的体积;d)从供者抽取全血;e)将抗凝剂以特定的比率ACR引入到所抽取的全血中;f)将所抽取的全血分离成血浆产品和包含红细胞的第二组分;g)将血浆产品采集在血浆采集容器中;h)在已从供者抽取到期望量的全血之后,将红细胞返回至供者;以及i)在每个采集阶段之前确定供者的Hct和VPP。
在第二方面,继续步骤d)至步骤i)直到采集容器中的血浆产品的测量体积等于VPP为止。
在第三方面,提供了一种用于采集血浆的方法,其中,在多个采集阶段中采集血浆产品,在所述多个采集阶段之间,将分离的红细胞再输注至供者。该第二方面的方法包括:a)确定供者的全血的体积Vb和血细胞比容Hct;b)基于Vb确定可以从供者采集的原料血浆的体积VRP;c)基于抗凝剂比率ACR和供者的Hct确定待添加至VRP的抗凝剂的体积VAC,使得VAC=VRP*(ACR*(1-Hct));d)确定可以采集的血浆产品的体积VPP,其中,血浆产品包括原料血浆体积VRP加抗凝剂的体积VAC;e)从供者抽取全血;f)将抗凝剂以特定的比率ACR引入到所抽取的全血中;g)将所抽取的全血分离成血浆产品和包含红细胞的第二组分;h)将血浆产品采集在血浆采集容器中;i)在已从供者抽取到期望量的全血后,将红细胞返回至供者;以及j)在每个采集阶段之前确定供者的Hct和VPP。
在第四方面,继续步骤d)至步骤j)直到采集容器中的血浆产品的测量体积等于VPP为止。
在第五方面,Vb是基于包括供者的重量、身高、性别、年龄和体型的一个或更多个供者特定特征来确定的。
在第四方面,提供了一种用于在单采过程中采集一定体积VPP的血浆产品的方法,其中,在多个采集阶段中采集血浆产品,在所述多个采集阶段之间,将分离的红细胞再输注至供者。在第四方面的方法中,VPP等于可以从供者采集的原料血浆的体积VRP加在单采过程期间添加至VRP的抗凝剂VAC的体积。该方法的步骤包括:a)确定供者的重量Wkg和性别M或F;b)确定供者的血细胞比容Hct;c)基于供者的重量Wkg和性别M或F确定可以采集的原料血浆的体积VRP;d)基于抗凝剂比率和供者的Hct确定VPP与VRP之间的比率K,使得K=VPP/VRP;e)确定VPP,使得VPP=VRP*K;f)从供者抽取全血;g)将抗凝剂以特定的比率ACR引入到所抽取的全血中;h)将所抽取的全血分离成血浆产品和包含红细胞的第二组分;i)将血浆产品采集在血浆采集容器中;j)在已从供者抽取到期望量的全血后,将红细胞返回至供者;以及k)在每个采集阶段之前确定供者的Hct和目标VPP。
在第五方面,重复步骤c)至步骤k),直到采集容器中的血浆产品的测量体积等于VPP为止。优选地,K=VPP/VRP=(ACR*(1-Hct/100)+1)/(ACR*(1-HCT/100))。
在第五方面,提供了一种用于在单采过程中采集一定体积VPP的血浆产品的方法,其中,在多个采集阶段中采集血浆产品,在所述多个采集阶段之间,将分离的红细胞再输注至供者。在该第五方面中,VPP等于可以从供者采集的原料血浆的体积VRP加在单采过程期间添加至VRP的抗凝剂的体积VAC。该方法的步骤包括:a)确定供者的重量Wkg和性别M或F;b)确定供者的血细胞比容Hct;c)基于供者的重量Wkg和供者的性别M或F确定可以采集的原料血浆的体积VRP;d)基于抗凝剂比率ACR和供者的Hct确定待添加至VRP的VAC,使得VAC=VRP*(ACR*(1-Hct));e)确定VPP,使得VPP=VRP+VAC;f)从供者抽取全血;g)将抗凝剂以特定的比率ACR引入到所抽取的全血中;h)将所抽取的全血分离成血浆产品和包含红细胞的第二组分;i)将血浆产品采集在血浆采集容器中;j)在从供者抽取到期望量的全血之后,将红细胞返回至供者;以及k)在每个采集阶段之前确定供者的Hct和VPP。
在第六方面,继续步骤d)至步骤k),直到采集容器中的血浆产品的测量体积等于VPP为止。
在第七方面,VRP通过下述方式确定:为供者重量的多个范围中的每个范围建立VRP并针对包括供者的重量在内的重量范围选择VRP。供者重量的范围可以分为三个类别:从110磅至149磅、从150磅至174磅、以及175磅以上。
在第八方面,VRP=K1*Wkg。
在第九方面,VRP不大于(1-Hct)*(Vb)的28.6%。
在第十方面,Vb是使用Nadler等式、Gilcher五分法、ICSH的标准以及任何其他普遍接受的方法中的一者确定的。
在第十一方面,VRP=Wkg*10mL/kg。
在第十二方面,在使用供者参数来估算供者的总血液体积Vb时,VRP=K2*Vb。
在第十三方面,提供了一种用于从全血分离血浆的自动系统,该自动系统包括可重复使用的硬件部件和一次性套件。一次性套件还包括:i)用于将全血分离成血浆部分和浓缩细胞部分的分离器,该分离器具有输入端、血浆输出端口和浓缩细胞出口端口,该输入端具有一体地连接至输入端的用于将全血从供者传送至分离器的血液管线,该血浆输出端口通过血浆管线一体地连接至血浆采集容器,该浓缩细胞出口端口一体地连接至储存器,储存器用于在再输注至供者之前接纳浓缩细胞;ii)终止于静脉穿刺针的供者管线,供者管线用于将全血从供者传送至血液管线;iii)抗凝剂管线,该抗凝剂管线一体地连接至血液管线并构造成连接至抗凝剂源,该抗凝剂管线用于将抗凝剂传送至供者管线;iv)构造成附接至生理盐水源的生理盐水管线,该生理盐水管线用于将生理盐水传送至血液管线;以及v)用于将浓缩细胞从储存器传送至供者管线的再输注管线。可重复使用的硬件部件还包括:i)蠕动式第一泵,用于在采集阶段期间将抗凝剂以受控的速率输送到血液管线中;ii)第二泵,用于在采集阶段期间将抗凝全血输送至分离器以及在再输注阶段期间使浓缩细胞组分返回;iii)第三泵,用于在采集阶段期间将浓缩细胞组分从分离器输送至储存器;iv)与血液管线、血浆管线、再输注管线和生理盐水管线中的每一者相关联的夹具;v)用于对血浆采集容器、储存器和抗凝剂源中的每一者进行称量的重量秤;以及vi)包括触摸屏的可编程控制器,该触摸屏用于接收来自操作者的输入,该可编程控制器配置成接收来自每个重量秤的信号并自动操作第一泵、第二泵和第三泵及夹具,以在采集阶段期间将全血分离成血浆部分和浓缩细胞部分以及在再输注阶段期间将浓缩细胞返回至供者。可编程控制器还配置成根据本文中所描述的方面中的任何方面确定待采集在血浆采集容器中的血浆部分的重量,并且可编程控制器配置成在接收到来自重量秤的关于血浆采集容器的等于由控制器确定的血浆组分的重量的信号时终止采集阶段。在对待采集的血浆产品的目标量进行确定时,控制器可以配置成在每个循环的采集阶段之前计算供者的血细胞比容。替代性地或附加地,控制器可以接收来自传感器等的指示供者的血细胞比容的信号。此外,血浆采集容器中的血浆产品的量可以由例如与血浆采集相关联的重量秤确定。在一个实施方式中,分离器包括转动隔膜分离器。
将理解的是,所描述的实施方式说明了本主题的原理的一些应用。在不脱离所要求保护的主题的精神和范围的情况下,本领域技术人员可以做出许多改型,包括本文中单独公开或要求保护的特征的那些组合。出于这些原因,权利要求的范围不限于以上描述,而是在所附权利要求中给出。
Claims (20)
1.一种用于采集血浆的系统,包括:
静脉穿刺针,所述静脉穿刺针构造成从供者抽取全血;
血液分离器,所述血液分离器构造成将所述全血分离成血浆产品和包括红细胞的第二血液组分,所述血液分离器具有联接至血浆管线的血浆输出端口,所述血浆管线构造成将所述血浆产品运送至血浆产品采集容器;
供者管线,所述供者管线流体地联接至所述静脉穿刺针,所述供者管线构造成将所述全血从所述供者引入至所述血液分离器,穿过所述供者管线的流由第一泵控制;
抗凝剂管线,所述抗凝剂管线联接至抗凝剂源,所述抗凝剂管线构造成将抗凝剂与来自所述供者的所述全血混合,穿过所述抗凝剂管线的流由第二泵控制;
触摸屏,所述触摸屏构造成接收来自操作者的输入;以及
控制器,所述控制器被编程为控制所述系统的操作,所述控制器被编程为:接收供者的重量和血细胞比容、确定血浆产品和/或原料血浆的目标体积、控制所述系统运行抽吸及返回循环以从所述供者抽取所述全血并将所述全血分离成所述血浆产品和所述第二血液组分并将所述第二血液组分返回至所述供者、建立所述供者的所述血细胞比容的当前值以及血浆产品和/或原料血浆的新目标体积、以及控制所述系统运行随后的抽吸及返回循环,由此在计算血浆产品和/或原料血浆的所述新目标体积时考虑所述供者的变化的血细胞比容。
2.根据权利要求1所述的系统,其中,所述控制器被编程为在第一抽吸及返回循环开始之前确定所述血浆产品和/或原料血浆的目标体积。
3.根据权利要求2所述的系统,其中,所述控制器被编程为重复抽吸阶段和返回阶段,直到采集到目标体积的血浆产品和/或原料血浆为止,其中,血浆产品和/或原料血浆的目标体积在每个抽吸阶段开始之前重新确定。
4.根据权利要求1所述的系统,其中,所述控制器被编程为基于所述供者的总血液体积和所述供者的血浆体积来确定血浆产品和/或原料血浆的目标体积。
5.根据权利要求1所述的系统,其中,所述控制器被编程为:当(1)血浆采集容器中的血浆产品的测量体积达到血浆产品的目标体积时和/或当(2)血浆采集容器中的原料血浆的体积达到原料血浆的目标体积时,开始将所述第二血液组分最终返回。
6.一种用于采集血浆的系统,包括:
静脉穿刺针,所述静脉穿刺针构造成从供者抽取全血;
血液分离器,所述血液分离器构造成将所述全血分离成血浆产品和包括红细胞的第二血液组分,所述血液分离器具有联接至血浆管线的血浆输出端口,所述血浆管线构造成将所述血浆产品运送至血浆产品采集容器;
供者管线,所述供者管线流体地联接至所述静脉穿刺针,所述供者管线构造成将所述全血从所述供者引入至所述血液分离器,穿过所述供者管线的流由第一泵控制;
抗凝剂管线,所述抗凝剂管线联接至抗凝剂源,所述抗凝剂管线构造成将抗凝剂与来自所述供者的所述全血混合,穿过所述抗凝剂管线的流由第二泵控制;
触摸屏,所述触摸屏构造成接收来自操作者的输入;以及
控制器,所述控制器被编程为控制所述系统的操作,所述控制器被编程为:至少接收供者的重量、身高、性别和血细胞比容,至少部分地基于所述重量、身高、性别和血细胞比容来确定血浆产品和/或原料血浆的目标体积,控制所述系统运行抽吸阶段和返回阶段以从所述供者抽取全血并将所述全血分离成所述血浆产品和所述第二血液组分并将所述第二血液组分返回至所述供者。
7.根据权利要求6所述的系统,其中,所述控制器被编程为基于原料血浆的目标体积VRP、所述血细胞比容Hct和抗凝剂比率ACR来确定血浆产品的目标体积VPP,使得:VPP=VRP*K,其中,K=(ACR*(1-Hct/100)+1)/(ACR*(1-Hct/100))。
8.根据权利要求6所述的系统,其中,所述控制器还被编程为考虑与所述血浆产品分开地引入到所述血浆采集容器中的抗凝剂。
9.根据权利要求6所述的系统,其中,所述控制器还被编程为考虑与所述血浆产品分开地引入到所述血浆采集容器中的、能够归因于预注或其他预处理步骤的抗凝剂。
10.一种用于采集血浆的系统,包括:
静脉穿刺针,所述静脉穿刺针构造成从供者抽取全血;
血液分离器,所述血液分离器构造成将所述全血分离成血浆产品和包括红细胞的第二血液组分,所述血液分离器具有联接至血浆管线的血浆输出端口,所述血浆管线构造成将所述血浆产品运送至血浆产品采集容器;
供者管线,所述供者管线流体地联接至所述静脉穿刺针,所述供者管线构造成将所述全血从所述供者引入至所述血液分离器,穿过所述供者管线的流由第一泵控制;
抗凝剂管线,所述抗凝剂管线联接至抗凝剂源,所述抗凝剂管线构造成将抗凝剂与来自所述供者的所述全血混合,穿过所述抗凝剂管线的流由第二泵控制;
触摸屏,所述触摸屏构造成接收来自操作者的输入;以及
控制器,所述控制器被编程为控制所述系统的操作,所述控制器被编程为接收供者的重量、身高和血细胞比容并确定包括原料血浆和抗凝剂的血浆产品的目标体积,其中,血浆产品的目标体积是在从所述供者抽取所述全血之前至少部分地基于抗凝剂比率、所述供者的重量、身高和所述供者的血细胞比容来确定的,所述控制器被编程为然后控制所述系统运行多个抽取及返回循环以从所述供者抽取所述全血并将所述全血分离成所述血浆产品和所述第二血液组分并将所述第二血液组分返回至所述供者。
11.根据权利要求10所述的系统,其中,所述控制器被编程为基于所述供者的总血液体积和所述供者的血浆体积来确定血浆产品的目标体积。
12.根据权利要求11所述的系统,其中,所述控制器被编程为基于选自所述供者的重量、身高、性别、年龄和体型的多个参数来确定所述供者的总血液体积。
13.根据权利要求10所述的系统,其中,所述控制器被编程为控制所述系统以将所述血浆产品采集于所述血浆产品采集容器中,直到所述血浆产品采集容器中的所述血浆产品达到血浆产品的目标体积为止。
14.一种用于采集血浆的系统,包括:
静脉穿刺针,所述静脉穿刺针构造成从供者抽取全血;
血液分离器,所述血液分离器构造成将所述全血分离成血浆产品和包括红细胞的第二血液组分,所述血液分离器具有联接至血浆管线的血浆输出端口,所述血浆管线构造成将所述血浆产品运送至血浆产品采集容器;
供者管线,所述供者管线流体地联接至所述静脉穿刺针,所述供者管线构造成将所述全血从所述供者引入至所述血液分离器,穿过所述供者管线的流由第一泵控制;
抗凝剂管线,所述抗凝剂管线联接至抗凝剂源,所述抗凝剂管线构造成将抗凝剂与来自所述供者的所述全血混合,穿过所述抗凝剂管线的流由第二泵控制;
触摸屏,所述触摸屏构造成接收来自操作者的输入;以及
控制器,所述控制器被编程为控制所述系统的操作,所述控制器被编程为:从供者管理系统以电子方式接收供者参数、至少部分地基于所述供者参数来确定血浆产品和/或原料血浆的目标体积、以及控制所述系统运行抽吸阶段和返回阶段以从供者抽取全血并将所述全血分离成所述血浆产品和所述第二血液组分并将所述第二血液组分返回至所述供者。
15.根据权利要求14所述的系统,其中,所述供者管理系统被编程为计算血浆产品和/或原料血浆的目标体积,并且所述控制器被编程为通过从所述供者管理系统接收血浆产品和/或原料血浆的目标体积而确定血浆产品和/或原料血浆的目标体积。
16.根据权利要求14所述的系统,其中,从所述供者管理系统以电子方式接收的所述供者参数包括供者重量和血细胞比容,其中,所述控制器被编程为至少部分地基于所述供者重量和血细胞比容来计算血浆产品和/或原料血浆的目标体积。
17.根据权利要求16所述的系统,其中,所述控制器被编程为基于所述供者的总血液体积和所述供者的血浆体积来计算血浆产品的目标体积。
18.根据权利要求17所述的系统,其中,所述控制器被编程为基于所述供者的重量和身高来而确定所述供者的总血液体积。
19.根据权利要求18所述的系统,其中,所述控制器被编程为确定包括原料血浆和抗凝剂的血浆产品的目标体积,其中,血浆产品的目标体积是在从所述供者抽取所述全血之前至少部分地基于抗凝剂比率、所述供者的重量和所述供者的血细胞比容来确定的。
20.根据权利要求14所述的系统,还包括与所述血液分离器分开的用于接纳浓缩红细胞的储存器。
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