CN116390781A - 用于从血液中去除物质的过滤器 - Google Patents
用于从血液中去除物质的过滤器 Download PDFInfo
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- CN116390781A CN116390781A CN202080107014.7A CN202080107014A CN116390781A CN 116390781 A CN116390781 A CN 116390781A CN 202080107014 A CN202080107014 A CN 202080107014A CN 116390781 A CN116390781 A CN 116390781A
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- A61M1/0218—Multiple bag systems for separating or storing blood components with filters
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- D06—TREATMENT OF TEXTILES OR THE LIKE; LAUNDERING; FLEXIBLE MATERIALS NOT OTHERWISE PROVIDED FOR
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- Chemical Kinetics & Catalysis (AREA)
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Abstract
公开了血液过滤器,其用于增强白细胞去除和血小板回收。所述过滤器包括涂覆有丙酮共聚物溶液的非织造多孔过滤器。
Description
技术领域
本公开内容一般地涉及过滤器,其用于从生物流体(例如血液)中去除物质(例如选定的组分和/或杂质)。更特别地,本公开内容涉及血液过滤器,其有效地去除不期望的组分(例如白细胞),同时允许有效地回收期望的血液组分(例如血小板)。甚至更特别地,本公开内容涉及包括这样的过滤器的血液过滤器组件以及用于制造这样的过滤器和过滤器组件的方法。
背景技术
使用多种手动和自动的***和方法,收集全血并经常将全血分离为其临床组分(通常为红细胞、血小板和血浆)。全血或所收集的组分通常单独储存并用于治疗多种特定病症和疾病状态。
在向需要组分的接受者输注血液或所收集的血液组分(“血液制品”)之前,通常期望使杂质或其他可在所述接受者中引起不期望副作用的物质的存在最小化。例如,由于可能的反应,通常认为在储存之前或至少在输血之前降低血液制品中的白细胞数量(即,“白细胞去除(leukoreduction)”)是期望的。
过滤器目前广泛用于实现血液制品中的白细胞去除(例如,从全血、红细胞和/或血小板制品中温过滤和冷过滤白细胞)。过滤器通常包含设置在过滤器壳体(housing)的接合壁(mating wall)之间的过滤器介质(filter media)。与壳体缔合的入口端口和出口端口提供从过滤器的内部来回的流动路径。壳体的壁可由刚性材料(通常是塑料)或柔性材料(通常是PVC)制成。由于过滤血液或血液组分的重要性,存在对改进生物流体过滤器的构造和性能的持续期望。
发明内容
在一个方面中,本公开内容涉及过滤器介质,其用于从血液中去除物质。所述过滤器介质包含多孔聚合物非织造材料(porous,polymeric non-woven material)用于从血液中去除选定组分并回收其他选定组分。所述过滤器介质包含涂覆物,其被施加至多孔聚合物材料。
在另一个方面中,本公开内容涉及血液过滤器组件,其包含具有入口和出口的壳体、预过滤器、后过滤器和位于预过滤器和后过滤器之间的过滤器介质,其中所述过滤器介质包含一片或更多片上述过滤器材料。
在另一个方面中,本公开内容涉及制造用于从血液中去除物质的过滤器的方法。所述方法包括形成由包含聚醚-酯共聚物的材料制成的织物片,以及用涂覆溶液涂覆该织物片的至少一侧,所述涂覆溶液是乙酸乙烯酯和乙烯基吡咯烷酮的共聚物。
附图说明
图1是根据本公开内容的代表性过滤器组件的前视图;
图2是沿图1的过滤器组件的2-2截取的侧视截面图;以及
图3是本公开内容的过滤器组件的分解图。
具体实施方式
本发明一般地涉及过滤器,其用于从血液中去除选定组分。术语“血液”包括全血和已从全血中分离出来的血液组分,例如红细胞。本文中所述的过滤器特别好地适用于(但不限于)过滤全血。
图1示出了根据本公开内容的过滤器组件的一个实施方案。过滤器10适用于从生物流体(例如血液)中去除选定组分和/或杂质。过滤器组件10包含外壳12,所述外壳12包含外壁14和16(图2)。壳体12以及实际上过滤器10优选地由生物相容性材料制成,所述生物相容性材料也可以是使用通常用于组装一次性血液处理装置(disposable bloodprocessing set)的常规灭菌技术(例如高压灭菌、γ射线和/或电子束)进行灭菌的。在一个实施方案中,壳体壁14、16可由在其***处或附近密封的刚性聚合物材料制成。壁14、16的密封可以通过黏合剂、焊接或其他形式的密封连接来实现。
在一个优选实施方案中,如图1和图2中所示,壳体壁14和16可以由柔软的柔性聚合物材料制成。用于外壳壁14和16的合适聚合物材料的实例包括聚氯乙烯和/或聚烯烃。如图1和图2中所示,壳体壁14和16可沿其***边缘结合以形成密封件18。在图1和2的实施方案中,还可提供另外的内周密封件20,如美国专利申请公开US 2002/0113003中所述,其内容通过引用并入本文。密封件18和20限定了缓冲的***部分。
通常地,本文中所述类型的过滤器组件可作为一次性流体处理装置或套件的一部分被包含在内,在那里,以最基础形式,生物流体从连接的或预连接的源引入,通过过滤器10,并在其已通过膜并且不期望的组分被过滤器介质捕获之后被收集在预连接的容器中。因此,壁14和16可分别包含入口端口24和出口端口26,以允许流体的引入和排出。端口24和26与由壳体壁14和16限定的内部腔室连通。端口24和26可由壁14和16承载,如图1和2中所示。端口24和26可单独地与壳体壁14、16连接,或者与壳体壁14和16一体成形。如图1和图2中所示,入口端口24和出口端口26可以以直径相对的关系位于壁14和16上。因此,例如,入口端口24可位于更靠近壁14上的过滤器10的“顶部”***边缘13,而出口端口26可位于更靠近过滤器10和壁16的“底部”***边缘15。当然,应当理解,端口14和16的相对位置可以以其他方式修改或提供。端口24和26限定内部流动路径,所述内部流动路径在内部腔室和通向一次性处理装置的其他容器或部分的管道(tubing)27之间建立流体连通,在所述一次性处理装置中包含过滤器10。
如图2至3中所示,壳体壁14和16容纳过滤器介质30。在一个实施例中,过滤器30可作为垫提供,所述垫包含多个堆叠的片,所述片具有一定尺寸的孔,以防止白细胞通过,同时允许其他期望的血液组分(例如红细胞和血小板)通过。在一个实施方案中,如图2中所示,过滤器30可包含多个片31,其中每个片31包含具有期望的直径和/或尺寸和分布的孔。在一个实施方案中,片31可由熔喷非织造纤维制成。根据本公开内容,纤维可由下文更详细描述的合适的聚合物材料制成。
如图3中所示,过滤器30可由多个熔喷非织造纤维片制成。另外,片的组可提供具有被选定来执行特定功能的过滤部分的过滤器介质。例如,过滤器30可包含由多个片构成的过滤器部分,其中过滤器部分32有选定的孔隙率,和/或构成部分32的邻近或最靠近壳体壁14和入口端口24的片具有选定的孔隙率,所述孔隙率提供了对微聚集物和较小尺寸的颗粒的去除。尽管图3示出了两片(仅出于代表性目的),但部分32可包含一片或更多片,并且通常可包含但不限于1至5片以提供“预过滤器”。
过滤器介质34可提供初级过滤器或主过滤器,并且同样可包含多个具有选定孔隙率的片。虽然仅示出了5片(仅出于代表性目的),但构成初级或主过滤器的片的数量可以是10至40的任意数量,其中每片的厚度为大约10μm至500μm。在一个实施方案中,大约30片可以包含在过滤器介质34中。
过滤部分36可以提供对另外的组分的过滤和/或用作过滤器介质34和壳体壁16之间的间隔元件。还可包含多个片(尽管仅出于代表性目的示出了一个片)的过滤器部分36位于过滤器介质34的下游,更靠近壳体壁16和出口端口26,并且可称为“后过滤器”。如图2中所示,过滤器部分32、34和36可聚在一起并被密封在一起以提供一体的过滤垫。或者,过滤器部分32、34和36中的每一者中的一些或所有单独的片可聚在一起并在内密封件20处与壳体壁14和16密封,如图2中所示。
过滤器介质34可以是由熔喷纤维制成的非织造材料,如美国专利No.7,736,516所述,其内容通过引用其整体并入本文。如其中所述,每片过滤器介质34可由合适的聚合物材料制成,例如聚醚-酯共聚物(polyether-ester copolymer,PEC)。
聚醚-酯共聚物可通过在至少一种亚烷基二醇、至少一种芳族二羧酸或其酯和聚环氧烷二醇的熔体中缩聚而获得。亚烷基二醇可包含2至4个碳原子,并且优选的二醇是亚丁基二醇。
合适的芳族二羧酸包括对苯二甲酸、1,4-萘二甲酸和4,4’-二苯基二羧酸。
优选的聚环氧烷二醇包括聚环氧丁烷二醇、聚环氧丙烷二醇和聚环氧乙烷二醇或其组合;特别优选的是聚环氧丙烷(polypropylene oxide,PPO)/聚环氧乙烷(polyethylene oxide,PEO)的嵌段共聚物。
所得聚合物具有由来源于亚烷基二醇(优选1,4-丁二醇)和芳族二羧酸(优选对苯二甲酸或对苯二甲酸二甲酯)的重复单元硬链段(疏水性)以及来源于聚环氧烷二醇的软亲水性链段构成的主链。
一个优选的所得聚合物结构是:
合适的聚环氧烷二醇可商购获得,例如Pluronic PE6002.TM.,其为用来自Basf的环氧乙烷二醇加帽的聚环氧丙烷(环氧乙烷:环氧丙烷=36/64-重量比)。
本文中所述的共聚醚酯是可商购的或可根据已知的缩聚方法,优选地根据美国专利No.6,441,125中所述的方法制备,其通过引用并入本文,所述方法通过在存在基于钛和二价金属在单一化合物中的组合或钛和包含二价金属的化合物的组合的催化剂的情况下在上述组分的熔体中缩聚,其中钛与二价金属的分子比值优选地低于1.5。
二价金属优选碱土金属,优选镁;钛优选地为金属有机化合物的形式,例如烷氧基钛(titanium alkoxide)或钛酯(titanium ester)。
根据本公开内容,本文中所述的共聚醚-酯可通过熔喷进行加工以获得直径在小于6μm且优选小于3μm范围内的纤维;优选的平均直径在1.8μm至2.2μm的范围内。
聚环氧烷二醇在共聚醚酯中的量优选地在聚环氧乙烷中以重量计为0.1%至20%或以重量计为0.03%至6%的范围内。
通过用涂覆溶液涂覆过滤器介质34(或其每一片)的表面,可进一步增强过滤器介质的白细胞去除和/或血小板回收。涂覆溶液可以是通过疏水性和亲水性单体(hydrophobic and hydrophilic monomer)的聚合反应获得的聚合物。
可用于涂覆溶液的合适的疏水性单体的实例包括乙烯基酯例如乙酸乙烯酯;烯烃,例如乙烯、丙烯、己烷-1、庚烯-1、乙烯基环己烷、3,3-二甲基-1-丙烯、3-甲基-1-二异丁烯、4-甲基戊烯-1;和来源于饱和醇的(甲基)丙烯酸烷基酯,例如丙烯酸甲酯、(甲基)丙烯酸乙酯、(甲基)丙烯酸丙酯、(甲基)丙烯酸正丁酯、(甲基)丙烯酸叔丁酯,该表述(甲基)丙烯酸酯并入了甲基丙烯酸酯和丙烯酸酯以及二者的混合物。
合适的亲水性单体的实例包括具有酸性基团的单体,例如乙烯基膦酸、乙烯基磺酸、丙烯酸和甲基丙烯酸;具有碱性基团的单体,特别是乙烯基吡啶、3-乙烯基吡啶、2-甲基-5-乙烯基吡啶、3-乙基-4-乙烯基吡啶、2,3-二甲基-5-乙烯基吡啶、N-乙烯基吡咯烷酮、2-乙烯基吡咯烷酮、N-乙烯基吡咯烷酮和3-乙烯基吡咯烷酮;以及具有极性基团的单体,例如2-甲基丙烯酰氧乙基磷酰胆碱、乙烯醇;乙烯醇可在聚合之后通过使乙烯酯皂化而获得。
合适的涂覆聚合物/共聚物的更具体的实例包括但不限于N-乙烯基-2-吡咯烷酮(N-vinyl-2-pyrrolidone,NVP)与乙酸乙烯酯(vinyl acetate,VAc)、甲基丙烯酸2-羟乙酯(2-hydroxyethyl methacrylate,HEMA)与乙酸乙烯酯(VAc)、N-乙烯基-2-吡咯烷酮与甲基丙烯酸2-乙氧基乙酯(2-ethoxyethyl methacrylate,2-EMMA)、N-乙烯基-2-吡咯烷酮(NVP)与甲基丙烯酸甲酯(methyl methacrylate,MMA)以及乙烯醇(vinyl alcohol,VA)与乙酸乙烯酯(VAc)。
在一个实施方案中,涂覆溶液可以是选定聚合物或共聚物的丙酮溶液。在一个更特别的实施方案中,涂覆溶液可以是乙酸乙烯酯和乙烯基吡咯烷酮(vinyl acetate andvinyl pyrrolidone,VA/VP)统计共聚物(statistical copolymer)的溶液。乙酸乙烯酯与乙烯基吡咯烷酮的重量比可以是10:1至4:1,更优选地为9:1至5:1,以及甚至更优选地为8:1至6:1。在一个实施方案中,乙酸乙烯酯和乙烯基吡咯烷酮(VA/VP)的重量比可以是7:1。例如,涂覆溶液可包含87.5%重量的乙酸乙烯酯和12.5%重量的乙烯基吡咯烷酮。其他共聚物溶液也可用于涂覆过滤器介质30并增强白细胞去除和血小板回收中的一者或二者。上述涂覆溶液的另一些的性质描述于美国专利No.7,775,376中,其内容通过引用并入本文。
可将一片非织造过滤器介质浸入丙酮涂覆溶液的浴(bath)中一段时间,该时间足以涂覆过滤器介质34的两个表面。涂覆溶液优选地包含约1%至5%聚合物,并且更优选地为1%至3%聚合物溶液或更优选地为2%(95%重量至99%重量的丙酮,并且更优选地97%重量至99%重量或更优选地98%重量的丙酮)。浸泡之后,使过量的涂覆溶液从介质表面滴下。一旦去除过量的涂覆溶液后,将过滤器介质干燥选定的时间段和/或在选定的干燥温度下干燥。干燥可在烘箱中或以本领域技术人员将认识到的方式通过使用干燥滚筒进行。在一个实施方案中,过滤器介质可在54℃至111℃的温度下干燥大约3至7秒并且优选大约5秒的时间。
在该卷经涂覆的过滤器介质(织物)已干燥之后,该卷可被切割成单独的片31。多个这些单独的片可被堆叠并与预过滤器和/或后过滤器的片组合以到达用于包含在如图1中所示的过滤器组件中的过滤垫处。
根据上述方法制备的经涂覆过滤器进一步增强了白细胞去除和血小板回收。以下列出了证明本文中所述经涂覆过滤器的改善的白细胞去除和血小板回收性质的测试结果。
实施例
用20层织物(20层过滤器介质,和3层预过滤器以及一层后过滤器,其中预过滤器包含一层纺粘(spunbond)PET和两层非织造熔喷聚PBT,并且后过滤器包含一层纺粘PET)生产小型过滤器(软外壳,正方形,表面积15cm2)。将如下所述的两种不同的过滤器介质“对照”a和“PEC-样本”进行比较。对照用标准PBT与VAVP涂覆聚合物(VA/VP重量比为7,0.22%w/w乙酰丙酮溶液)组合进行制备,而PEC样本包含与VAVP涂覆聚合物(VA/VP重量比为7,2%w/w乙酰丙酮溶液)组合的PEC织物。
在具有70ml CPD的PVC袋中从知情供体收集血液单元(500ml±10%,不包括CPD)。收集之后,将血液袋在室温下储存在丁烷-1,4-二醇冷却板上多至24小时。过滤之前,将收集的血液与过滤***连接。对每个袋进行三次过滤(160g收集血液用于每个过滤器)。通过重力进行过滤。
在血液袋过滤之前和之后收集样品以评价白细胞(white blood cell,WBC)去除和血小板(platelet,PLT)回收(通过Sysmex KX-21N自动血液学分析仪进行细胞计数)。在经过滤的血液中,通过流式细胞术计数WBC。还测量了160g血液收集时的总过滤时间。结果列于下表1中。
表1
如表1中所示,当与用本文中所述涂覆溶液涂覆的其他织物相比时,使用涂覆的PEC作为织物材料提高了回收血小板的能力,同时允许充分去除白细胞并缩短过滤时间。
应当理解,上述实施方案举例说明了本发明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,本领域技术人员可做出许多修改,包括本文中单独公开或要求保护的那些特征的组合。出于这些原因,本文的范围不限于以上描述,而是在所附权利要求书中阐述。
Claims (16)
1.用于从血液中去除物质的过滤器介质,其包含:
多孔聚合物非织造织物,其用于从血液中去除选定组分并回收其他选定组分,所述织物包含具有亲水性链段和疏水性链段的非织造材料;
涂覆物,其被施加至所述多孔聚合物织物。
2.权利要求1所述的过滤器,其中所述多孔聚合物织物包含聚醚-酯共聚物。
4.权利要求1至3中任一项所述的过滤器,其中所述疏水性链段包括来源于亚烷基二醇和至少一种芳族二羧酸或酯的重复单元。
5.权利要求1至4中任一项所述的过滤器,其中所述亲水性链段来源于至少一种聚环氧烷二醇。
6.权利要求1至5中任一项所述的过滤器,其中所述涂覆溶液通过疏水性和亲水性单体的聚合反应获得。
7.权利要求6所述的过滤器,其中所述疏水性单体选自乙烯基酯、烯烃和甲基丙烯酸烷基酯,并且所述亲水性单体选自具有酸性基团的单体、具有碱性基团的单体和具有极性基团的单体。
8.权利要求1至7中任一项所述的过滤器,其中所述涂覆物包含含有乙酸乙烯酯和乙烯基吡咯烷酮的共聚物的丙酮溶液。
9.权利要求8所述的过滤器,其中所述乙酸乙烯酯与乙烯基吡咯烷酮的比例为10:1至4:1。
10.血液过滤器组件,其包含:
壳体,所述壳体包含入口和出口;
预过滤器;
后过滤器;和
过滤器介质,其位于所述预过滤器与所述后过滤器之间,所述过滤器介质包含一片或更多片权利要求1至7中任一项所述的过滤器。
11.权利要求10所述的血液过滤器组件,其中所述过滤器介质包含堆叠的多个所述过滤器片。
12.制造用于从血液中去除物质的过滤器的方法,其包括:
形成包含聚醚-酯共聚物的织物片;
用包含乙酸乙烯酯和乙烯基吡咯烷酮的共聚物的涂覆溶液涂覆所述织物片的至少一侧。
13.权利要求12所述的方法,其中所述涂覆包括将所述织物浸入所述涂覆溶液的浴中。
14.权利要求13所述的方法,其还包括从织物片去除过量的涂覆溶液。
15.权利要求12所述的方法,其还包括在54℃至111℃的温度下干燥所述经涂覆的织物片。
16.权利要求10至15中任一项所述的方法,其包括由熔喷纤维形成所述织物,所述熔喷纤维由所述聚醚-酯共聚物制成。
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PCT/EP2020/081612 WO2022100814A1 (en) | 2020-11-10 | 2020-11-10 | Filter for removing substances from blood |
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US (1) | US20240058518A1 (zh) |
EP (1) | EP4243957A1 (zh) |
JP (1) | JP2024501103A (zh) |
KR (1) | KR20230106162A (zh) |
CN (1) | CN116390781A (zh) |
WO (1) | WO2022100814A1 (zh) |
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NL1010385C2 (nl) | 1998-10-23 | 2000-04-26 | Dsm Nv | Bereiding van een copolyetherester. |
JP4038547B2 (ja) | 2000-05-26 | 2008-01-30 | バクスター・インターナショナル・インコーポレイテッド | 血液フィルター、採血処理システムおよびその方法の改良 |
ITTO20030039A1 (it) * | 2003-01-24 | 2004-07-25 | Fresenius Hemocare Italia Srl | Filtro per separare leucociti da sangue intero e/o da preparati derivati dal sangue, procedimento per la fabbricazione del filtro, dispositivo e utilizzazione. |
JP2004339165A (ja) * | 2003-05-16 | 2004-12-02 | Asahi Kasei Corp | 医療用具用コート材およびこれを用いた白血球除去フィルター |
ES2280656T3 (es) | 2003-07-03 | 2007-09-16 | Fresenius Hemocare Italia S.R.L. | Filtro para la eliminacion de sustancias de productos sanguineos. |
EP2495025A1 (en) * | 2011-03-04 | 2012-09-05 | Fresenius Medical Care Deutschland GmbH | Filter for the removal of micro-vesicles from biological fluids, methods and devices using such a filter |
FR3003764B1 (fr) * | 2013-03-27 | 2015-05-01 | Maco Pharma Sa | Unite de filtration des leucocytes a adhesion des plaquettes reduite |
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- 2020-11-10 EP EP20808025.9A patent/EP4243957A1/en active Pending
- 2020-11-10 US US18/250,379 patent/US20240058518A1/en active Pending
- 2020-11-10 WO PCT/EP2020/081612 patent/WO2022100814A1/en active Application Filing
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JP2024501103A (ja) | 2024-01-11 |
US20240058518A1 (en) | 2024-02-22 |
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