CN1207078C - 包含一个整体弹性过滤器的血液采集系统 - Google Patents

包含一个整体弹性过滤器的血液采集系统 Download PDF

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Publication number
CN1207078C
CN1207078C CNB018001467A CN01800146A CN1207078C CN 1207078 C CN1207078 C CN 1207078C CN B018001467 A CNB018001467 A CN B018001467A CN 01800146 A CN01800146 A CN 01800146A CN 1207078 C CN1207078 C CN 1207078C
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China
Prior art keywords
filter
blood
filter medium
medium
filter course
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CNB018001467A
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CN1362891A (zh
Inventor
丹尼尔·R·林恩
朱利安·布赖拉特
约翰·伯纳姆
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Fenwal Inc
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Baxter International Inc
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Priority claimed from US09/498,085 external-priority patent/US6367634B1/en
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D29/00—Filters with filtering elements stationary during filtration, e.g. pressure or suction filters, not covered by groups B01D24/00 - B01D27/00; Filtering elements therefor
    • B01D29/01—Filters with filtering elements stationary during filtration, e.g. pressure or suction filters, not covered by groups B01D24/00 - B01D27/00; Filtering elements therefor with flat filtering elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/02—Blood transfusion apparatus
    • A61M1/0209—Multiple bag systems for separating or storing blood components
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    • A61M1/0218—Multiple bag systems for separating or storing blood components with filters
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    • B29L2031/7148—Blood bags, medical bags

Abstract

一种血液采集系统，它包括一个整体弹性过滤器以便从血液成分中除去白血球。所述过滤器包括含有一种可熔化材料的第一和第二弹性薄片(32，34)、含有一种可熔化材料的深度过滤介质(28)、一个将所述薄片(32，34)直接连接到所述过滤介质(28)上以使所述过滤介质(28)密封在所述第一和第二薄片(32，34)之间的外周密封(36)，其中所述密封包括一种含有所述薄片(32，34)材料和所述过滤介质(28)材料的共混合熔化基质。

Description

包含一个整体弹性过滤器的血液采集系统
发明领域：
本发明主要涉及血液采集和处理系统和方法。
发明背景：
由多个连通的塑料袋构成的系统已经在血液成分的采集、加工和贮存中得到广泛的应用和接受。采用这些系统，可收集全血并将其分离成临床使用的成分(通常为红血球、血小板和血浆)。这些成分单独贮存并用于治疗各种各样的特定疾病和病情。
在贮存用于后来输血的血液成分之前，据信使存在的杂质或其它物质(它们可能会在接受者体内产生不希望的副作用)最小化是人们所希望的。例如，由于可能的反应，在贮存之前，或者至少在输血之前，从血液成分中除去基本上所有的白血球，一般是人们所希望的。
传统方法是采用过滤来实现白血球的减少。通过在多个血液袋结构中的过滤以降低白血球数目的系统和方法在例如Stewart的美国专利4,997,577、Stewart等人的美国专利5,128,048、Johnson等人的美国专利5,180,504和Bellotti等人的美国专利5,527,472之中有描述。
发明概述：
本发明提供了一种血液采集系统，它包括一个用来盛放血液的容器和一个与所述容器连通的过滤器。所述过滤器包括第一和第二含有可熔化材料的弹性薄片和一个含有可熔化材料的深度过滤介质。外周密封将所述薄片直接连接到所述的过滤介质上，使所述过滤介质密封在第一和第二薄片之间。所述的密封包括一种混合的熔化基质，该基质包含所述薄片材料和所述过滤介质材料。
在一个优选实施例中，所述过滤介质可将血液中的白血球除去。
本发明的其它特征和优点，在阅读了下述的说明、附图和所附权利要求书之后，将会变得更为清楚明了。
附图的简要说明
图1所示为包含有一个整体弹性的可用来从红血球中除去白血球的过滤器的血液采集和贮存系统的示意图；
图2所示为可形成图1所示系统一部分的整体弹性过滤器的分解透视图，给出了通过整体外周密封的入口和出口部件；
图3所示为图2所示的整体弹性过滤器的组合透视图；
图4所示为可形成图1所示系统一部分的整体弹性过滤器的一个替代实施例的组合透视图，给出了不通过整体外周密封的入口和出口部件；
图5所示为图2所示整体弹性过滤器的预组合形式的透视图解示意图，它是由连续的长胶片组合成的；
图6所示为图5所示的整体弹性过滤器的预组合形式的侧视图，当它在两个隔开的射频能量模具间通过时；
图7所示为图6所示的整体弹性过滤器的预组合形式的侧视图，它由模具接合，可应用射频能量形成整体的外周密封；
图8所示为多个密封过滤器组的顶视图，它们是连续地形成的，且被模具分割成可集成为图1所示系统中的单独的过滤器20；
图9所示为一个血液采集和贮存系统的示意图，它包含有一个可从红血球中除去白血球的整体弹性过滤器，并带有一个用来排放所述过滤器附近空气的旁路通道；
图10所示为一个血液采集和贮存系统的示意图，它包含有一个可从红血球中除去白血球的整体弹性过滤器，并带有一个整体空气排放袋；
图11所示为一个血液采集和贮存系统的示意图，它包含有两个整体弹性过滤器，一个用来从红血球中除去白血球，另一个用来从富含血小板的血浆中除去白血球；和
图12所示为一个血液采集和贮存系统的示意图，它包含有一个在离心加工处理之前从全血中除去白血球的整体弹性过滤器。
本发明并不局限于下述说明书或附图所示中给出的具体结构和部件排列。可以使用其他实施方案和以其他不同的方式实施本发明。所用术语和词组是用来说明的，不应该理解为对本发明的限定。
优选实施例的说明
图1所示为具有一个整体弹性过滤器20的人工血液采集和贮存系统10。所述系统10可保证基本不含有白血球的红血球能够长期地贮存。所述系统10可保证血小板浓缩物和低浓度血小板的血浆能够长期地贮存。正如由美国的应用标准所确认的，所述血液采集和贮存系统10，一经消毒，就可形成一个消毒的“封闭”系统。所述系统10是一种可处置的一次性使用的物品。
如图1所示，系统10包括一个主袋12和三个转换袋或容器14、16和18。正如所述的弹性过滤器20一样，所述的转换袋14、16和18也都整体地连接到所述的系统10之上。在使用时，以常规方法操作所述系统10。所述主袋12(它也称作供血袋)，经由一个与其整体连接的，带有一个放血针24的供血管22接受来自献血者的全血。在所述主袋12中含有一种合适的抗凝血剂A。全血在所述的主袋12中，采用传统方法经离心分离为红血球和富含血小板的血浆。白血球居于所述红血球和富含血小板血浆之间的层面。
转换袋14用来接收由采集在所述主袋12中的全血中分离出来的富含血小板的血浆。当从所述主袋12中转移出富含血小板的血浆时，就能够将白血球尽可能多地保留在所述主袋12中。富含血小板的血浆向转换袋14中的转移，使红血球和白血球留在所述的主袋12中。
转换袋16含有一种适于红血球贮存的溶液S。这种溶液公开在Grode等人的美国专利4,267,269中，它由巴克斯特保健公司以商标名ADSOL溶液出售。所述贮存溶液S是在所述富含血小板的血浆转移到所述转换袋14中之后，转移到所述主袋12之中的。
所述富含血小板的血浆是采用常规方法在所述转换袋14中被离心分离为血小板浓缩物和除去血小板的血浆。所述除去血小板的血浆被转移到转换袋16中，此刻转换袋16中的贮存溶液S已被倒空。所述转换袋16用作除去血小板的血浆的贮存容器。所述转换袋14用作所述血小板浓缩物的贮存容器。
所述贮存溶液S与存留在所述主袋12中的红血球和白血球进行混合。贮存溶液S、红血球和白血球的混合物经由管线26从所述主袋12中转移出来。所述管线26与整体弹性过滤器20成一条直线连接。所述弹性过滤器20包括放置于壳体30之内的过滤介质28。所述过滤介质被选择用来从红血球中除去白血球。
所述除去白血球的红血球进入转换袋18。转换袋18用作除去白血球的红血球的贮存容器。
与所述处理系统10相关的袋和管线，可由常规被认可的医用等级的塑料材料制成，如以苯二甲酸二-2-乙基已酯增塑的聚氯乙烯(PVC-CEHP)。所述袋是采用传统热封技术形成的，例如，射频(RF)热封。
一种替代方案是，由于所述转换袋14可用来贮存血小板浓缩物，所以它可由聚烯烃材料(如Gajewski等人在美国专利4,140,162中所公开)或以偏苯三三-2-乙基已酸酯(TEHTM)增塑的聚氯乙烯材料制成。这些材料与DEHP-增塑的聚氯乙烯材料相比，具有更大的透气性，这对于血小板的贮存是有利的。
所述弹性过滤器20，与所述系统10中的其它元件一样，也是可处置的一次性使用的物品。而且，与所述系统10中的其它元件一样，所述过滤器壳体30是采用常规被认可的医用等级的塑料材料制成的。此外，与所述系统10中的其它元件一样，所述过滤器壳体30是采用传统的射频热封技术形成的。所述过滤器20是弹性的，便于操作并可减少在离心处理过程中发生的对所述系统10中其它部件的损害。
在图示实施例中(参见图2)，所述过滤器壳体30包括第一和第二薄片32和34，它们是由医用等级的塑料材料制成的，如以苯二甲酸二-2-乙基已酯增塑的聚氯乙烯(PVC-DEHP)。也可采用不是PVC和/或不含有DEHP的其它医用等级的塑料材料，只要所述材料置于射频能量之中能够发热并流动即可。
所述过滤介质28是由一种纤维材料制成的，它夹心地位于所述薄片32和34之间。所述过滤介质28可以单层排列，或以多层堆叠形式进行排列。所述介质28可含有熔喷的或纺丝粘合的合成纤维(例如，尼龙或聚酯或聚丙烯)、半合成纤维、再生纤维或无机纤维。在使用中，所述介质28通过深度过滤除去白血球。
在所述图示实施例中，所述过滤介质28，沿着血液流动方向，包括一个预过滤区、一个主过滤区和一个后过滤区。所述预过滤器和后过滤器是由具有不适合除去白血球的孔径尺寸和纤维直径的纤维材料制成的(例如，聚乙烯)。相反，所述预过滤器的纤维材料，其尺寸大小是用来除去血液中存在的大的血块和凝聚物。所述后过滤器的纤维材料尺寸大小是用来在所述过滤器的出口提供流体汇流管效果。在一个具有代表性实施例中，所述预过滤材料的孔径尺寸在约15-约20μm之间。所述主过滤区是由一种具有可通过深度过滤除去白血球的孔径尺寸和直径大小的纤维材料制成的(例如，聚乙烯)。所述主过滤区的材料可具有Watanabe等人在美国专利4,701,267或Nishimura等人在美国专利4,936,998中所述的特征，在此引入这些专利作为参考。
如已经公开的文献所述，所述过滤介质28可以制成对称形式的，这样无论流动方向如何在流经所述介质28进程中所接触的过滤介质的材料层都是相同的。这样，所述介质28的每一侧都可用作入口或出口。过滤介质28的这种对称性质简化了制造方法，使得在制造中没有必要区分所述过滤介质28的“入口”和“出口”侧面或所述薄片32和34的“入口”或“出口”取向。
按照本发明，整体连续的外周密封36是通过在一个单一过程中，对所述两个薄片32和34和过滤介质28施加压力和射频加热而形成。所述密封36将所述两个薄片32和34彼此连接在一起，如同将所述过滤介质28连接到所述两个薄片32和34之间一样。所述密封36使所述的过滤介质28的材料和所述塑料薄片32和34的材料形成一个可靠的、坚固的、防漏的整体边界。由于所述密封36是整体且连续的，所以可以避免血液沿所述过滤介质28的周边分流。
所述过滤器20还含有入口和出口部件38和40。所述部件38和40包括由医用等级的塑料材料如PVC-DEHP制成的管线。如图3所示，所述部件38和40可位于所述整体外周密封36中，并在形成所述的整体外周密封36的同时密封在适当的位置。一种替代方案是采用与Fischer等人在美国专利5,507,904中所述的方法同样的方式进行的(参见图4)，所述部件38和40可在形成所述整体外周密封之前的一个单独的组合过程中，插入并密封到薄片32和34之中。还有一种替代方案是，所述部件38和40可包括单独的模型部件，它们是在所述薄片中形成的小孔上通过射频能量进行热密封而成的。
如上所述，所述过滤介质28的对称取向可使所述过滤器20能够“适合各个方向”。所述部件38可以取向放置分别用作入口部件或出口部件，而另一个部件40用作相应的出口部件或入口部件，反之亦然。
所述过滤器20(参见图5)是由所述第一和第二塑料薄片32的连续长胶片42和44所形成的。过滤介质28的层由连续长胶片46提供。所述连续长胶片42、44和46提供一个连续分层的过滤器预组件48。所述预组件48以测量好的位移被送至一对模具50和52之间(参见图6)。在每次位移之间，所述相对模具50和52移动到一起(参见图7)，施加压力使所述预组件48的周边边缘挤压到一起。优选地，提供一个挡板54用来精确地间隔所述的模具50和52使之彼此分离。
在所述模具50和52对所述周边边缘施加压力时，通过所述的模具50和52施加RF能量。RF能量和压力的结合，可使所述薄片32和34的塑料材料软化。所施加的压力使得所述薄片32、34的热软化材料能够透过所述过滤介质28的空隙，从而形成过滤介质材料与薄片材料共混合的内部基质。在所述基质中，所述过滤介质熔化形成一种复合密封36。
沿着所述薄片32和34，在其表面，所述密封36主要包括所述薄片32和34的材料。随着离表面的距离的增加，所述密封36包括一种所述薄片32和34的材料和所述过滤介质28的材料共混合熔化的基质。因为所述薄片材料可经通电加热并可通过所施加的射频能量引起流动，还可进一步由所施加的压力导致流入并透过所述的介质28的间隙，这样便形成了共混合熔化的基质。所述在压力作用下流入到所述介质28的间隙中的受热的薄片材料可引起所述介质28自身发生熔化。
在经过短期的冷却之后，撤下所述密封36装置和所述模具50和52。在一个具有代表性的实施例中，所述模具50和52被连接到一个4KW的射频能量发生器之上。施加60PSI的压力，并保持模具间隙为1.2mm。采用的密封时间约为5.5秒，随后冷却约5秒。
如图8所示，多个密封过滤器组件56可依次地沿着预组件48形成。所述过滤器组件被模具分割为单独的过滤器20(如图8中的虚线84所示)。然后将所述过滤器20结合到血液处理和采集系统10，如图1所示。
如图6和7所示，当所述部件管38和40位于所述外周密封36之中时，则所述模具50和52可配置对准的凹槽58。所述凹槽58对齐以容纳所述部件管38和40。所述模具50和52围绕部件管38和40并沿着预组件48的余下周边结合在一起。心轴(图中未画出)插入所述管38和40之中，以防止所述管38和40在形成密封36时发生变形。在密封36冷却后移去心轴。
一旦结合成所述系统10，则所述弹性过滤器壳体30可包括一个容积可变的容器，它可在过滤之后用来接受留在所述转换袋18中的残余空气。在这种设计中，在除去白血球的红血球已经从所述过滤器20转移到所述袋18之后，残余空气受压从所述转换袋18回到所述过滤器壳体30中。过滤器20的逆流管可以被钳住以将空气栏截在过滤器壳体30中。由于是弹性的，所以所述过滤器壳体30可膨胀容纳残余的空气体积。
一种替代方案是，所述转换袋18中的残余空气可经由一个绕过所述过滤器20的空气排放通道被转移回到所述主袋12之中。例如，如图1所示，管道60从所述转换袋18通向所述主袋12，残余空气可经由它从所述转换袋18中排放出来。
为了替代所述管道60(参见图9)，可在所述过滤器20周围设置一个空气旁路通道62。一个同轴的单向阀64，可设置在所述旁路通道62中，以防止血液流过指向所述转换袋18方向的通道。在另一个替代设计方案中(参见图10)，所述转换袋18中的残余空气，可经由一个整体空气排放管68被转移到一个空气排放袋66之中。
弹性过滤器可以不同方式结合到多个血液袋系统之中。例如(参见图11)，与图1所述相似的系统10’，可包括第二个整体弹性过滤器20’，串联在位于所述主袋12和所述转换袋14之间。在这种设计中，所述过滤介质28’是选用来在除去血小板的血浆进入所述转换袋14之前从其中除去白血球。
作为另一个实例，图12给出了一种包括一个主袋72和转换袋74、76、78的系统70。所述主袋72接受献血者的全血。全血经由管线80从所述主袋72转移到所述转换袋74中。所述管线80成一线地带有一个如前所述的整体弹性的过滤器82。所述过滤介质84用来从所述全血中除去白血球，但不会也除去血小板或红血球。所述除去白血球的全血在所述转换袋74中进行离心处理，分离为红血球和富含血小板的血浆，它们两者都除去了白血球。
所述转换袋76接受所述的除去白血球的富含血小板的血浆，而除去白血球的红血球则贮存在所述转换袋74中。所述富含血小板的血浆在所述转换袋76中采用常规方法被离心分离为血小板浓缩物和除去血小板的血浆。所述除去血小板的血浆，转移到所述转换袋78中贮存。这将使所述血小板浓缩物存留在所述转换袋76贮存容器中。
本发明的所用弹性过滤器，可避免以往刚性过滤器壳体存在的操作和处理问题。与刚性壳体不同，所述弹性过滤器壳体30也是由弹性的塑料材料制成的，因此不会刺破相关的袋，并且所述弹性过滤器壳体30可符合并适应使用过程中所引入的应力和压力。
在所述过滤器20入口端，所述弹性薄片32和过滤介质28之间的紧密接近可形成毛细作用，在来自源容器的重力流的流体高压差下，它有助于空气的排出和所述过滤器20的自动起动。所述流体高压差可使在起动之后的弹性薄片32扩大或膨胀。这样，就可形成一个天然的压力歧管，它可均匀地分布所述流体流过所述过滤介质28的入口平面。这可保证截留空气得以排放出来，并能保证所述流体在均匀压力的分布下流过所述过滤介质28。
当所述流体容器放空时，所述过滤器20下游会形成负压。由于所述过滤器壳体30的入口和出口薄片32和34是弹性的，所以，它们将会在所述过滤介质28占据的空间附近发生收缩，使在使用之后存留在所述过滤器20中的残余血液量达到最小。不需要采用辅助的空气排放装置，流体就可从所述出口端得以排放出来。
采用同样的方法，所述弹性过滤器20在使用过程中会对上游闭塞或阻塞作出直观的指示。如果在使用过程中的闭塞发生在所述过滤器20上游的入口管道(例如，由所述管道中扭结的形成或管线内血块的形成所引起)中，则所述过滤器壳体30的入口和出口薄片32和34，将会通过收缩作出反应，与由于空的源容器所引起的情形完全相同。所以，在使用过程中，所述过滤器20的意外的收缩表明所述过滤器20上游存在闭塞。
此外，所述弹性过滤器壳体30在加热消毒过程中不会破裂，而且在加热消毒过程中，也不会阻止热量的渗透。相反，所述过滤器壳体30可允许均匀的热量渗透进入到所述过滤介质28之中。所述过滤器20，可在整个系统10消毒的同时进行消毒，这使得一步消毒方法变为可能。
本发明的多方面特征如随后的权利要求书中所述。

Claims (7)

1.一种血液过滤装置，包括第一和第二弹性薄片，其中每一弹性薄片均包含一种可熔化材料；一个包含一个预过滤层、一个主过滤层和一个后过滤层的过滤介质，每一层包含一种可熔化材料，其中予过滤层和后过滤层的可熔化材料实质上是一样的，由此在流经过滤介质时，无论流向如何，遇到的过滤介质的层在顺序上实质上是一样的；一个外周密封，其通过在一个单一过程中利用射频加热及施加压力把所述第一和第二弹性薄片与所述过滤介质直接连接在一起，以使所述过滤介质密封在所述第一和第二薄片之间而形成的，其中所述第一弹性薄片处于予过滤层的上面，所述第二弹性薄片处于后过滤层的上面，且主过滤层被夹在预过滤层与后过滤层之间，所述外周密封包括一种含有所述薄片材料和所述过滤介质材料的连续共混合熔化基质；一个把血液传输到过滤介质的入口部件；一个把血液送出到过滤介质的出口部件；所述后过滤层的可熔化材料为血液通过出口部件提供了一种流体汇流管效果。
2.权利要求1所述的血液过滤装置，其中主过滤层的可熔化材料通过深度过滤从血液中除去白血球。
3.权利要求1所述的血液过滤装置，其中预过滤层的可熔化材料除去血液中的血块。
4.权利要求1所述的血液过滤装置，其中入口部件位于与所述外周密封相间隔的第一弹性薄片中，其中出口部件位于与所述外周密封相间隔的第二弹性薄片中。
5.权利要求1所述的血液过滤装置，其中入口部件和出口部件至少有一个是位于外周密封中。
6.一个血液采集系统，包括一个用来盛放血液的容器，一个权利要求1，2，3，4或5的血液过滤装置，和将所述过滤装置连接到所述容器上的管线。
7.一个血液过滤组件，包括多个权利要求1的血液过滤装置，以靠近并排的方式串联。
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BR0104379A (pt) 2002-01-02
CN1362891A (zh) 2002-08-07
KR20010108436A (ko) 2001-12-07
US6745902B2 (en) 2004-06-08
WO2001056679A1 (en) 2001-08-09
US7353956B2 (en) 2008-04-08
CA2368645A1 (en) 2001-08-09
US20040149646A1 (en) 2004-08-05
AU3661801A (en) 2001-08-14
NO20014800L (no) 2001-12-03
EP1204447A1 (en) 2002-05-15
IL145306A0 (en) 2002-06-30
EP1204447A4 (en) 2009-07-22
AU780793B2 (en) 2005-04-14
MXPA01010043A (es) 2002-06-21
JP4186096B2 (ja) 2008-11-26
JP2003521358A (ja) 2003-07-15
US20020148764A1 (en) 2002-10-17
KR100808691B1 (ko) 2008-02-29
CA2368645C (en) 2010-01-26
US6422397B1 (en) 2002-07-23
IL145306A (en) 2005-11-20
NO20014800D0 (no) 2001-10-03

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