CN1246048C - 骨再生材料 - Google Patents

骨再生材料 Download PDF

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CN1246048C
CN1246048C CNB018144829A CN01814482A CN1246048C CN 1246048 C CN1246048 C CN 1246048C CN B018144829 A CNB018144829 A CN B018144829A CN 01814482 A CN01814482 A CN 01814482A CN 1246048 C CN1246048 C CN 1246048C
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蒂埃里·斯托尔
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Abstract

本发明涉及一种用于制备骨再生材料的方法，根据所述方法，一种具有生物相容的、带有通透微孔的多孔体(3)被暴露于真空中，并利用微孔中所形成的真空将自由流动形态的骨诱导物质和/或成骨物质吸入到多孔体(3)的微孔中。因而，就可以制备出这样一种骨再生材料：其在生物相容多孔体(3)的微孔中容纳着骨诱导物质和/或成骨物质，所述物质作为一种网格结构，可便于新的体细胞生长到多孔体(3)内。

Description

骨再生材料
技术领域
本发明涉及一种如权利要求1的前序部分所述的、用于制备骨替代材料的方法；如权利要求9的前序部分所述的、用于执行该制备方法的装置；以及，如权利要求11的前序部分所述的骨替代材料。
背景技术
在由SUMITOMO CEMENT公司提交的第60-142857号日本专利申请中，公开了一种羟基磷灰石多孔体，其可容纳水、水性氯化钠溶液、血液以及人造血浆。但在该文献中，并未具体指出这种羟磷灰石体中的微孔是否为相互连通的。
在专利文献PCT/EP99/00684中披露的骨替代材料不会带来生物排异反应，并具有骨传导属性。此处所用的术语“骨传导”含义是指：成骨细胞的生长，并是指：在内原性材料或所植入的外原性材料的表面上发生的、没有形成中间层组织的骨再生，其中，所述外原性材料不会由于骨的生长而被替换掉。
这些现有材料的缺点在于它们缺乏骨诱导属性。此处所用的词语“骨诱导”的含义是指：在人体中的组织分布方面基本上非生理性的干涉。骨诱导应被看作是在一个不具有任何骨组织的组织区中对骨生成的引发、刺激的过程，其中，不具有任何骨组织的组织区在当前的情况下也即是指生物材料中不具有相互连通的微孔结构。
发明内容
本发明致力于对此进行改进。因而，本发明的一个目的是提供一种简单而可靠的方法，该方法用于制备一种骨替代材料，尤其是一种骨诱导性获得改善的材料。本发明的另一个目的是设计一种改进的骨替代材料。
根据本发明，通过权利要求1特征部分中描述的方法而实现了上述目的。
由此所获得的优点在于这样的事实：生物相容体的微孔中的体细胞(例如血液或更确切来讲血液中所含的血纤维蛋白)能形成了一种网状结构，其能诱使新的体细胞向内生长到所述多孔体中。采用血液具有另外的有利之处：可用血小板中所含的生长刺激素来激发骨细胞，使其向多孔体内生产。
根据本发明的方法具有优点：多孔体并不是被简单地浸入到体细胞的悬浮液(例如血液中)，使微孔系统利用毛细作用来灌注悬浮液，而是使相互连通的微孔暴露到真空中，通过真空作用使自由流动状态的体细胞(例如以血液的形式存在或以水性悬浮液的形式形式)被主动地吸入到多孔体中，使自由流动态的体细胞能均匀地散布到多孔体，甚至到达多孔体的最内心部分。
本发明所能达到的优点基本上在于：根据本发明制备的骨替代材料具有相互连通的微孔结构，其在被植入到病变部位之前，已经充入了适当的体细胞，此体细胞例如为血液、血液成分、骨髓、或骨细胞(如为此目的所希望的那样，所有这些体细胞都以流体的形态存在)，且该骨替代材料具有骨诱导属性。类似于在骨折治愈中所观察到的过程，结构内的血液凝块能被更好地组织成为富含体细胞和脉管的肉芽结缔组织，该组织具有很低的纤维含量，其通常被称为肉芽组织。各种细胞进入到该组织中，并开始形成一种软骨基质。该过程持续进行，直到整个肉芽组织被软骨所取代为止，软骨在后来再发生钙化。如果不具有本发明所能达到的优点，则部分微孔中只被空气所填充，从而使所述的生物过程在总体上被放慢、甚至成为不可能的。
也可以不采用血液或血液复合制品，根据自由流动的定义，体细胞也可被悬浮在具有生物相容性的流体中一优选地是在某种水性溶液中，以使其易于被多孔体中的连通微孔所吸收。
根据一种优选的方法，是从如下的分组中来选择体细胞的：自体骨髓；从自体骨髓中提取出的浓缩分离细胞；培养出的自体干细胞；分化出的自体干细胞；或间叶细胞。
通过未成熟的造血细胞可连续地形成末稍血细胞的前驱细胞，其中的未成熟造血细胞通常被称作干细胞。
优选的是，所述体细胞是属于自体同源性质的，也就是说，体细胞的捐赠者和受体是同一个人。
在本发明一优选实施例中，以自由流动形态存在的体细胞与多种可诱发骨形成的药剂混合，这些药剂例如为：
a)合成生长因子；
b)重组细胞生长因子，优选为β型生长因子(TGF-β)或FGF-2因子(成纤维细胞生长因子)；
c)天然或人工合成的缩氨酸；
d)血小板衍生生长因子(PDGF)；
e)类胰岛素生长因子(IGF)；
f)作为血液凝结最终产物的血纤维蛋白；或
g)人工合成的血纤维蛋白。
优选的是，用于根据本发明方法的、带有连通微孔的多孔体至少部分地是由一种可被生物再吸收的材料组成的，优选为羟磷灰石材料、三价磷酸钙、聚合的丙交酯、或任何具有生物再吸收性的聚合材料或共聚材料。该多孔体的孔隙率至少应为25％，优选为至少35％。这些微孔中应当有多于50％的微孔的直径在200微米到500微米之间。各条微孔之间的连通点的直径应当在10到300微米之间，优选的是在200微米到400微米之间。
附图说明
在下文中，将参照一个实施例对本发明、以及本发明进一步的发展做详细的描述。
在附图中
图1是一个剖视图，表示了一种适于制造根据本发明的骨替代材料的注射器。
具体实施方式
图1所示的注射器被用来制备根据本发明的骨替代材料。其包括：一中空的筒体1；一活塞2，其被设置成可在中空筒体内移动；以及一头部4，其上设置有螺纹，从而可从中空筒体1的前端部分上拆下。所述头部4上设置有一隔膜5，为了能抽取捐赠者的血液，所述隔膜被一配接头6刺穿，该配接头6上装有一个针头7，其穿过所述隔膜。在头部4上使用该配接头使得该注射器可与任何的标准插管系统(例如Luer皮下注射针系统、导尿管、蝶状插管等)相配合。在中空筒体1内，容纳了一个具有连通微孔的生物相容体3，其密封地配插到注射器的前部中，从而能迫使患者的血液或血液成分流经该多孔体3。多孔体至少部分地是由可被生物吸收的材料制成的，优选为羟磷灰石、三价磷酸钙、聚合丙交酯等。在血液被从捐赠者中抽取之来之后，将配接头6去掉，从而使头部4的隔膜5恢复其不可透过性，由此将注射器中空筒体1中的成分再次气密地密封起来。随着将活塞2在注射器的中空筒体1中进一步地向后拉，就会形成一个真空环境，该真空能促使血液完全地渗透过多孔体3，甚至进入到多孔体的最内心部分，并排出其中所含的空气。
在多孔体3被血液或血液成分(或以自由流动形态存在的其它体细胞)浸透之后，将头部4从注射器上旋下，从而可利用活塞2将浸透的多孔体3从中空筒体1中推出。如果必要的话，还可将已被定形的多孔体3加工成特定的形状，然后再插入到患者骨头中一个已被准备好的孔腔中，或骨头的一个病变部位处，其中，浸透多孔体所需的血液或其它体细胞就是从该患者抽取的。由于多孔体3具有相互连通的微孔结构，且在微孔系统中容纳了自体血液(或血液成分或其它体细胞)，能显著地有利于体细胞向多孔体3内的生长。

Claims (16)

1.用于制备骨替代材料的方法，所述骨替代材料包括骨诱导物质和/或成骨物质，该方法的特征在于：
A)将一带有完全连通微孔的、生物相容的多孔体(3)暴露于真空中；以及
B)利用多孔体(3)的微孔中所形成的真空，将以自由流动形态存在的骨诱导和/或成骨物质吸入到所述微孔中。
2.根据权利要求1所述的方法，其特征在于：成骨物质的存在形式为可自由流动的体细胞，由此，所述体细胞可从如下的分组中选择：a)自体骨髓；b)从自体骨髓中提取出的浓缩分离细胞；c)培养出的自体干细胞；d)分化出的自体干细胞；或e)间叶细胞。
3.根据权利要求1所述的方法，其特征在于：所述骨诱导物质容纳在一具有生物相容性的流体中，该流体为水性溶液。
4.根据权利要求1所述的方法，其特征在于：所述骨诱导物质悬浮在一具有生物相容性的流体中，该流体为水性溶液。
5.根据权利要求1所述的方法，其特征在于：所述自由流动形态的体细胞是从如下的分组中选出的：A)血液；B)血液成分；C)骨髓；或D)自由流动形态的骨细胞。
6.根据权利要求1或2所述的方法，其特征在于：所述体细胞是属于自体同源性质的。
7.根据权利要求1或2所述的方法，其特征在于：所述骨诱导物质是从如下的分组中选出的：
a)合成生长因子；
b)重组细胞生长因子；
c)天然或人工合成的缩氨酸；
d)血小板衍生生长因子(PDGF)；
e)类胰岛素生长因子(IGF)；
f)作为血液凝结最终产物的血纤维蛋白；或
g)人工合成的血纤维蛋白。
8.根据权利要求1或2所述的方法，其特征在于：该方法是借助于一注射器来执行的，该注射器包括一中空筒体(1)和一活塞(2)，从而，利用该注射器来吸取自由流动形态的骨诱导物质和/或成骨物质，并使之流经注射器中空筒体(1)中所容纳的多孔体(3)的微孔。
9.装置，用于执行根据权利要求1到8之一所述的方法，其特征在于：所述装置包括一注射器，该注射器包括一中空筒体(1)和一活塞(2)，其中，在所述中空筒体(1)中放置一带有完全连通微孔的生物相容多孔体(3)——其至少部分地密封了所述中空筒体(1)，从而迫使被注射器所吸取的、自由流动形态的骨诱导物质和/或成骨物质必然流经所述多孔体(3)的微孔。
10.根据权利要求9所述的装置，其特征在于：所述注射器包括一固定在所述中空体(1)前端的头部(4)，所述头部配有一隔膜(5)，从而，在密封所述隔膜(5)并回拉所述活塞(2)之后，借助于真空，被注射器所吸取的、自由流动形态的骨诱导和/或成骨物质必然流经所述多空体(3)的微孔。
11.骨替代材料，其包括一带有完全连通微孔的生物相容多孔体(3)，其特征在于：所述多孔体(3)的至少部分微孔中填充了骨诱导物质。
12.骨替代材料，其是根据权利要求1到8之一所述方法制备而成的。
13.根据权利要求11或12所述的骨替代材料，其特征在于：所述多孔体(3)至少部分地是由可被生物再吸收的材料组成，由羟磷灰石或三价磷酸钙组成。
14.根据权利要求11或12所述的骨替代材料，其特征在于：所述多孔体(3)的孔隙率至少为25％。
15.根据权利要求11或12所述的骨替代材料，其特征在于：多于50％的微孔的直径在200微米到500微米的范围内。
16.根据权利要求11或12所述的骨替代材料，其特征在于：各个微孔间连接点的直径在10微米到300微米的范围内。
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