CN1121199C - 血液成分的贮存容器 - Google Patents

血液成分的贮存容器 Download PDF

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CN1121199C
CN1121199C CN95191306A CN95191306A CN1121199C CN 1121199 C CN1121199 C CN 1121199C CN 95191306 A CN95191306 A CN 95191306A CN 95191306 A CN95191306 A CN 95191306A CN 1121199 C CN1121199 C CN 1121199C
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block copolymer
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vinyl acetate
vinyl
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CN1139378A (zh
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I·T·帕特尔
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Baxter International Inc
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Abstract

本发明提供了一种能挤出、吹塑和用环氧乙烷及辐射消毒的软塑料配制剂。本发明的塑料配制剂包括：a)占约6-94%(重量)的基本上由乙烯和乙酸乙烯酯单元组成的共聚体；b)占约5-25%(重量)的嵌段共聚物，该嵌段共聚物基本上由包括总体上等同比例的乙烯和丁烯单元的中间嵌段共聚物分子和聚苯乙烯端嵌段组成；和c)占约1-15%(重量)的超低密度聚乙烯材料。本发明的塑料配制剂可用于制造血袋、管子等。

Description

血液成分的贮存容器
技术领域
本发明总体上涉及塑料配制剂。更具体说，本发明涉及适于与人的血液及其成分接触的医用级塑料配制剂。
背景技术
大多数收集起来的全血并不贮藏和用于输血。相反，全血被分离成医疗上确认的成分，这些成分贮存于塑料容器之中。这些医疗用的全血中的血液成分包括红细胞、血小板和许多其它血浆成分，如白蛋白、血浆蛋白成分、γ-球蛋白和因子VIII。
仅提供全血中处置特定疾病所需的医疗用血液成分，对病人的治疗更为有利。因此对全血中的医疗用血液成分的需求日益增长。相应地，对收集、分离和贮存全血中的医疗用成分的安全有效的系统及方法的需求也在增长。
通常，全血及其成分收集并贮存于医疗用塑料配制剂比如聚氯乙烯(PVC)塑料配制剂制造的容器中。出于需要，这些PVC配制剂必需增塑剂，因为PVC本身直接用于这些容器显得不够软。已知增塑剂会浸提或萃取到贮存于PVC容器中的血液成分里。虽然并没有已知的与增塑剂浸提到血液成分中相关的反面生理结果，但是理所当然最好能将血液成分与通常在人体中见不到的任何材料的相互接触减少到最低程度。
出于需要，PVC配制剂还必须包括热稳定剂，以防止在加工过程中及其后发生热降解和颜色改变。同增塑剂一样。热稳定剂也会浸提到血液成分中去。包括增塑剂和热稳定体系的PVC配制剂在如美国专利第4,505,708号中已有描述。
血液贮存容器的另一重要特征是透气性。透气性非常重要，以使血液成分中的活细胞如红细胞和血小板能交换氧气和二氧化碳。这允许活的血液成分的生活力延长和较长的贮存时间。对于PVC塑料配制剂，随着增塑剂用量的减少，透气性一般降低。透气性降低对某些血液成分比如血小板的贮存不是最适宜的。
由于PVC塑料配制剂的问题及缺点，人们已做出了一些努力，以开发适于贮存血液成分的非PVC塑料材料。这些材料包括柔性聚酯和聚烯烃。令人惊奇的是，许多这些材料经试验后，虽然表现为可作为血袋制造商的良好塑料材料，但是会致使贮存于容器里的血液中血浆血红素高到不能令人满意的程度。这表明这些容器中的红细胞的溶解率高。用非PVC塑料配制剂制造的血袋例子在美国专利第4,112,982号、第4,140,162号、第4,301,800号、第4,479,989号和第5,026,347号中已有公开。这些专利中的一些也公开了降低红细胞溶解的添加成分例如柠檬酸酯，和加入到塑料插入物中的抗溶血增塑剂。
血液成分贮存容器的消毒也是非常重要的。优选地，容器应该用环氧乙烷和/或辐射如γ射线消毒。美国专利第4,479,989号公开的技术表明，虽然包括聚丙烯的塑料配制剂可以热消毒，但是因为它不能用辐射消毒，仍不能令人满意。
再则，在低温下贮存时塑料配制剂仍应保持柔软性。公开的文献表明，包括聚丙烯均聚物或共聚物或共混物的塑料材料，在低温下变脆且本性又刚硬。当然这是缺陷。
所以，提供一种塑料配制剂，它能通过挤出和/或吹塑成形而制备医用液体的容器；所述容器的膜体柔软可折叠，该膜体具备良好的低温柔软性；有足够的耐温性可防止软化和/或熔融，并可用辐射或气体消毒；具备足够的透气性，以提供其中活的细胞成分或其它细胞物质的生活力；将是有利的。如果容器具备优异的光学清晰度和柔软性及强度的配合，使之在宽的温度范围内有优异的使用性能，也将是有利的。
发明内容
本发明的一个方面是提供了一种可挤压或吹塑且能辐射消毒的柔软性塑料配制剂。该塑料配制剂包括：a)占约60-94％(重量)基本上由乙烯和乙酸乙烯酯单元组成的共聚物；b)占约5-25％(重量)的嵌段共聚物，该嵌段共聚物基本上由如下成分组成：一个包括总体上等同比例的乙烯和丁烯单元共聚分子的中间嵌段，和聚苯乙烯端嵌段；和c)占约1.0-15％(重量)的超低密度聚乙烯材料。
本发明的另一方面是提供了一种从本发明的塑料配制剂制造的能挤压和/或吹塑成型且经辐射消毒的软性可折叠容器。
本发明的又一方面是提供一种在由本发明的塑料材料制造的容器中贮存血液成分例如压积红细胞(packed red blood cells)或血小板的方法。
附图说明
图1是一个用体现了本发明特点的塑料配制剂制造的血液成分容器的平面示图。
具体实施方式
本发明提供了一种软塑料配制剂，以及制造和使用这一塑料配制剂的方法。优选地，本发明的塑料配制剂用于制造软性可折叠容器，例如塑料血袋，塑料管等，以及医用溶液的容器。同样可以预想的是，本发明的塑料配制剂可普遍地用于其它各种软性容器和物体，因为本发明提供了如下优点：可挤出和吹模、具有良好的低温脆度，且可以气体和辐射消毒。本发明的另一个非常重要的优点是：从本发明的塑料配制剂制造的血袋表现出优异的透气性。
本发明的塑料材料在一个宽的温度范围内是柔软而有挠性的。而且，本发明的塑料配制剂优选地基本上不含液体增塑剂、热稳定剂和抗溶血剂。因此使用时，如制造成血袋后，从塑料浸提到血液中的物质达到了很低的水平。根据本发明，提供了一种软性塑料配制剂，这种塑料能经挤出和/或吹塑成可辐射消毒的软性可折叠容器。
本发明的塑料配制剂优选地包括三种成分。第一种成分是基本上由乙烯和乙酸乙烯酯单元组成的共聚物。第二种成分是一种嵌段共聚物，该嵌段共聚物基本上由一个中间嵌段共聚物分子和端聚合物嵌段组成，中间共聚物分子含有总体上等同比例的乙烯和丁烯单元，端聚合物嵌段是聚苯乙烯(SEBS)。第三种成分是一种超低密度聚乙烯材料。这些用于制备本发明的塑料配制剂的成分使用传统塑料混合方法充分掺合，再经挤出和/或吹塑成薄膜、管子等，以制造接受其中包括血液成分在内的血液成分的软性容器。
关于乙烯-乙酸乙烯酯共聚物成分(EVA)，此共聚物在本发明的塑料配制剂中的量为占配制剂总重量的约60-94％。此共聚物在本塑料配制剂中的量更优选占配制剂总重量的约70-87％。然而最优选地，乙烯-乙酸乙烯酯共聚物在本发明的塑料配制剂中的量为占配制剂总重量的78-82％。
本发明中所采用的乙烯-乙酸乙烯酯共聚物优选包含约18-40％(重量)的乙酸乙烯酯单元。所述共聚物更优选包含约22-35％(重量)的乙酸乙烯酯单元。但最优选地，所述共聚物包含约25-30％(重量)的乙酸乙烯酯单元。一种优选的乙烯-乙酸乙烯酯共聚物材料以Ultrathene的商品名称出售，产品牌号UE-634，Quantum Chemicals生产，包含约28％(重量)的乙酸乙烯酯单元。
关于嵌段共聚物成分，根据一种优选实施方案，此嵌段共聚物成分在本发明的塑料配制剂中的重量为占配制剂重量的约5.0-25％。更优选地，此嵌段共聚物的重量为占配制剂重量的约10-20％。但最优选地，此嵌段共聚物在本发明的塑料配制剂中的重量为占塑料配制剂重量的约14-18％。
特别优选的嵌段共聚物成分是市售商品名为Kration G，产品牌号1652和1657，例如来自Shell Chemical Company的产品。优选地，该嵌段共聚物的分子量为约50,000-120,000道尔顿。更优选地，该嵌段共聚物的分子量为约70,000-100,000道尔顿。在本发明中有用的嵌段共聚物成分在美国专利第4,140,162中有描述，该专利内容在此引为参考。优选地此嵌段共聚物中的乙烯及丁烯部分占此嵌段共聚物分子重量的约50-85％。
关于超低密度聚乙烯材料(ULDPE)，在本发明中，ULDPE意指那些乙烯/α-烯烃共聚物，其密度低于约0.925g/cm3，且更优选地，低于约0.900g/cm3或更低，可甚至低于0.800g/cm3。该ULDPE材料在本塑料配制剂中的量为占塑料配制剂重量的约1.0-15.0％。更优选地，此ULDPE材料的量为占塑料配制剂重量的约3.0-10.0％。最优选地，此ULDPE材料的量为占塑料配制剂重量的约4.0-6.0％。商业上优选的ULPDE材料可从Mitsui Petrochemical Inc.获得，其商业名称为Tafmer，产品牌号A 4085。
关于附图，图1所示的是一个血液成分贮存容器10，它体现了本发明的一个方面。容器10可有多种构造。在图示的实施方案中，容器10包括一个入口管(inlet)12，一段管子14与之连成一体。
管子14可以在其末端包括一个放血针(未示出)。在这种排布时，管子14起的作用是：将全血从献血者导引入容器10供处理加工，优选贮存某些血液成分。优选地，全血或至少一种血液成分贮于容器内。优选的血液成分包括血小板、经包装的红细胞、血浆和血浆基成分(plasma based fractions)。
或者，管子14可与另一容器的内部相连(亦未示出)，此容器用本发明的塑料配制剂制成。在这种排布时，管子14起如下作用：将另一容器内容物一部分导入容器10供进一步进行优选贮存的加工处理。而且如图所示，容器10包括若干通常是密封的但可选择性地开启的入口(access port)16。在某些实施方案中，入口16和入口12可包括一个共挤出或层压的PVC层(未示出)。内PVC层使得PVC管子与容器10的入口12可用溶剂粘合(solvent bonding)。
根据本发明，容器10的壁18用本发明的塑料配制剂制成，且可以用加热或射频密封技术(radio frequency sealing techniques，RF)密封。优选地，本发明的塑料配制剂基本不含增塑剂和热稳定剂。优选地，壁18的厚度为至少0.005英寸，并且优选约0.01～0.02英寸，但室温下仍保持柔软性和可折叠。
本发明的各成分可在普通高分子混合设备中用传统方法制成配制剂，例如，各成分可以在螺带式掺混器(ribbon blender)中翻转混合(tumble-blended)。混合得到均匀混合物之后，本发明塑料配制剂可用传统设备加热、熔融和挤出。如果需要，材料然后可以吹塑，或用其它传统方法制成合适的容器。
以下实施例描述了本发明的优选实施方案及用途，除非附后的权利要求另有声明，其意不在于限制本发明。
实施例1
膜的透气性试验
透气性是按ASTAM D-398(N.A.)DIN 53380(欧洲)、JIS K-7126(亚洲)的方法测量氧气透气性。所用“OXTRAN”系统由Mocon Inc。Minneapolis，Minnesota生产。该OX TRAN系统使用独有的传感器探测通过平面膜的氧气传送率。根据所用方法，一个膜试样夹入扩散池，上下两室开始时用无氧的载气清洗，以清除系统内的残余氧气并使试样上吸收的氧气脱出。然后将氧气传感器接通到载气流中。当确定稳定零点后，将氧气导入上层扩散室。通过膜扩散入下层室的氧气分子被载气带到传感器。所得结果列于下表1。
关于二氧化碳的透气性，用“Permatron-C-Rod”系统探测通过平面膜的二氧化碳传送率。将一片膜夹持于上现两半层之间。气体二氧化碳通入上半层，同时不含CO2的氮气载气冲过下半层。当通氮一侧自动接通红外传感器时，一个测试循环开始。当CO2分子透过试样进入封闭回路(closed loop)，红外探测器监测通过膜的二氧化碳传送率。
表1
 材料I.D.  O2c.c/100in2/天  CO2，c.c/100in2/天
(A) 104 520
(B) 81 686
(C) 77 371
(D) 194 1282
(E) 83 425
(F) 137 1304
材料A，B，C，D，F和G是市售用于制造血小板贮存容器的膜。材料D是用本发明的塑料配制剂按实施例4制造的膜。本发明膜的O2扩散性比任何其它所试的膜都优越得多。本发明膜的CO2扩散性比除膜C和F之外的其它膜都好。膜B、C和F是PVC基的膜。材料A、B、C、E分别是PL-732、PL-2209、PL-1240和PL-269，可从Baxter Healthcare Corporation获得。材料E可从Cobe公司获得。
实施例2
冲击性能
本发明的一种膜的冲击性能(低温使用)用Applied Science SOP#06KPO9-00中描述的方法测定。在-60℃到45℃之间，以约3m/sec的冲击速度和5.77kg落重(falling weight)测定冲击性能。用本发明的塑料配制剂制造的膜(H)(见实施例4)在接近-55℃出现从延性到脆性的破坏。试验结果列于表2。表2
膜 冲击/转变范围**℃
A -15到-10
B -30到-25
C -30到-25
D -30到-25
E -20到-10
F -20到-10
G -50到-60
**脆性/延性转变范围
材料A-F是市售用于制造血小板贮存容器的膜。材料G是按实施例4所述制造的本发明的膜。本发明的膜表现出优越的低温使用性(handlingcharacteristics)。这是非常重要的，因为血液成分通常在很低的温度下冷冻。材料A-D分别是PL-146、PL-732、PL-1240和PL-2209，可从BaxterHealthcare Corporation获得。材料E是Cutter CLXTM，得自Cutter Inc。材料F得自Kawasumi Corporation。材料A、C、D、E和F是PVC基材料。
实施例3
血小板贮存容量
数据表明，100ml血浆中，用本发明的膜制造的血小板容器(B)中的血小板贮存容量(storage capacity)比商业血小板容器(A)(PL-732，Baxter HealthcareCorporation)的要大。
表3
结果：血小板贮存容量结果
血小板容量和透气性 (A)1000ML容器 (B)1000ML容器
100ml血浆中的血小板，5天    3.1×1011   4.2×1011
实施例4
配制剂
材料说明 浓度，％
EVA，UE 634 80％
SEBS，KRATON G-1652 15％
ULDPE，TAFMER A-4085 5％
每一成分经称重后用螺带式掺混器混合。掺混物用标准挤出工艺加工后造粒。造粒后的材料用于挤出单层膜。膜厚为.010”-.011”。膜表面用无光塔夫绸保护，以防止膜片之间粘结。膜厚度范围优选约.005”-.02”。
在不背离本发明下述权利要求定义的概念及范围的条件下，可以变动本发明描述的组成、操作及方法的安排。

Claims (9)

1.一种软塑料配制剂，它可被挤出，吹塑并且可以辐射消毒，它包括：
a)占重量约60-94％，基本上由乙烯和乙酸乙烯酯单元组成的一种乙烯-乙酸乙烯酯共聚物；
b)占重量约5-25％的嵌段共聚物，此嵌段共聚物基本上由如下成分组成：一个包括总体上等同比例的乙烯和丁烯单元的中间嵌段共聚物分子和聚苯乙烯端嵌段；和
c)占重量约1-15％的超低密度聚乙烯材料，
其中的乙烯-乙酸乙烯酯共聚物包括占重量约10-40％的乙酸乙烯酯单元，嵌段共聚物分子量为约50,000-120,000道尔顿，并包括占重量约50-85％的中间嵌段共聚物分子。
2.一种软性可折叠的容器，它能辐射消毒，制造它的塑料配制剂包括：
a)占重量约60-94％，基本上由乙烯和乙酸乙烯酯单元组成的一种乙烯-乙酸乙烯酯共聚物；
b)占重量约5-25％的嵌段共聚物，此嵌段共聚物基本上由如下成分组成：一个包括总体上等同比例的乙烯和丁烯单元的中间嵌段共聚物分子和聚苯乙烯端嵌段；和
c)占重量约1-15％的超低密度聚乙烯材料，
其中的乙烯-乙酸乙烯酯共聚物包括占重量约10-40％的乙酸乙烯酯单元，嵌段共聚物分子量为约50,000-120,000道尔顿，并包括占重量约50-85％的中间嵌段共聚物分子。
3.权利要求2的容器，其中的塑料配制剂包括：
a)占重量约70-87％的乙烯-乙酸乙烯酯共聚物；
b)占重量约10-20％的嵌段共聚物；和
c)占重量约3-10％的超低密度聚乙烯材料。
4.权利要求2的容器，其中的塑料配制剂包括：
a)占重量约78-82％的乙烯-乙酸乙烯酯共聚物；
b)占重量约14-16％的嵌段共聚物；和
c)占重量约4-6％的超低密度聚乙烯材料。
5.权利要求2的容器，其中该容器用于盛装血液成分。
6.权利要求5的容器，其中所述血液成分选自血浆、压积红细胞和血小板。
7.权利要求5的容器，其中的血液成分是血小板。
8.一种多层层压膜，该膜包括至少一层由包含如下成分的塑料配制剂制造：
a)占重量约60-94％，基本上由乙烯和乙酸乙烯酯单元组成的一种乙烯-乙酸乙烯酯共聚物；
b)占重量约5-25％的嵌段共聚物，此嵌段共聚物基本上由如下成分组成：一个包括总体上等同比例的乙烯和丁烯单元的中间嵌段共聚物分子和聚苯乙烯端嵌段；和
c)占重量约1-15％的超低密度聚乙烯材料，
其中的乙烯-乙酸乙烯酯共聚物包括占重量约10-40％的乙酸乙烯酯单元，嵌段共聚物分子量为约50,000-120,000道尔顿，并包括占重量约50-85％的中间嵌段共聚物分子。
9.一种由多层塑料层压材料制造的容器，它包括至少一层由包含如下成分的塑料配制剂制造：
a)占重量约60-94％，基本上由乙烯和乙酸乙烯酯单元组成的一种乙烯-乙酸乙烯酯共聚物；
b)占重量约5-25％的嵌段共聚物，此嵌段共聚物基本上由如下成分组成：一个包括总体上等同比例的乙烯和丁烯单元的中间嵌段共聚物分子和聚苯乙烯端嵌段；和
c)占重量约1-15％的超低密度聚乙烯材料，
其中的乙烯-乙酸乙烯酯共聚物包括占重量约10-40％的乙酸乙烯酯单元，嵌段共聚物分子量为约50,000-120,000道尔顿，并包括占重量约50-85％的中间嵌段共聚物分子。
CN95191306A 1994-11-22 1995-08-22 血液成分的贮存容器 Expired - Lifetime CN1121199C (zh)

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