CN1229147C - 使骨组织和/或结缔组织向内生长并生长的物体及制造该物体的方法 - Google Patents

使骨组织和/或结缔组织向内生长并生长的物体及制造该物体的方法 Download PDF

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CN1229147C
CN1229147C CNB008068011A CN00806801A CN1229147C CN 1229147 C CN1229147 C CN 1229147C CN B008068011 A CNB008068011 A CN B008068011A CN 00806801 A CN00806801 A CN 00806801A CN 1229147 C CN1229147 C CN 1229147C
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implant
growth
porous
tissue
osseous tissue
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CN1356914A (zh
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I·布鲁斯
L·布鲁斯
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Tigran Technology (PUBL) Co. Ltd.
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BRUCE MEDICAL AB
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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Dermatology (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Dispersion Chemistry (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
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Abstract

一种物体，例如颗粒，用于提供骨组织和/或结缔组织向内生长和生长，该物体由可塑的或基本无弹性的生物相容性材料构成，优选金属或金属合金，它还是多孔的，并具有下列多孔特性：(a)多孔是连续的，(b)空腔/凹槽/孔洞和使它们互连的管道的开口对于骨组织具有大于约50微米的宽度而对于结缔组织具有大于约10微米的宽度。一种用于制造这种物体的方法，该物体是通过向熔融的金属吹气形成的。根据本发明的该物体的有利用途是将它包裹在形成有开口的外壳内，用于制造诸如脊髓植入体一类的植入体。

Description

使骨组织和/或结缔组织向内生长 并生长的物体及制造该物体的方法
SE-B-462,638公开了一种用于固定纵长的假体，诸如股骨干假体于活体组织内的装置，该装置界定了一个将一段假体安放到其中的腔，其中假体与腔的边界之间有一个间隙。基本上整个间隙用疏松的、但生物相容性材料的压紧的颗粒填充，所述颗粒互相交锁。作为一个颗粒材料的例子提到了钛，该颗粒被规定应该是不规则形的、基本无弹性的，并且优选多孔的材料，后一种特性被认为能与已经从骨壁生长的骨组织结合生长。多孔性是通过向熔化的颗粒材料吹气而获得的。
US-A-5,217,496公开了一种适合用于活体骨组织内的植入体，它包括具有多孔的外表和相连的混合物层的钛支持体，其中的混合物由碎裂的活体骨组织和钛粉组成。给这种混合物提供营养以使得碎裂的骨组织生长，并形成使碎裂的骨组织和钛粉彼此连接并与支持体连接的组织。
US-A-5,676,700公开了一种生物可相容的结构单元，用于修复、加强和替代骨组织，所述单元被认为可在骨组织腔内形成骨导或骨诱导基质。该单元的材料可以是钛并且有利地该单元是使自身的骨组织向内生长的微孔。
所有上面文献中提到的生物相容性的材料，除了钛之外，还可以是羟基-磷灰石、生物陶瓷、生物玻璃。
因此，在上面的文献中，指出生物相容性材料的多孔性可产生有利于结合骨组织的优势。
根据本发明，令人惊奇地发现生物相容性材料的多孔性的预定测量实际上是关于骨组织生长率的决定性因素。已经发现，当表面多孔性确实能够结合骨组织时，骨组织的生长率明显增强，并可获得大量骨，因此，在下列条件下可明显改善在生物相容性材料上的骨组织的锚固和强度，
-生物相容性材料的物体，例如颗粒是连续地多孔，
-物体的多孔性具有最低限度值。
与骨不能向内生长的情况相比，有骨组织向内生长的多孔颗粒的强度大得多，由此可得到本发明的另一个优势。由于有骨组织向内生长，所以强度主要由骨组织来负担，这从生物力学的观点来看是有利的。
这里所用的“连续多孔”是指使得骨组织能够生长到诸如生物相容性材料的颗粒这一类多孔物体内的多孔性。根据本发明，这种多孔性引起在通过管道、通路互相连接的物体中出现空腔，从而使在物体外表面部分的骨组织的生长能够穿过该物体及其外表面的其它部分连续生长。空腔是指任意形状的凹槽、孔洞、空穴，连接这些空腔的管子和通道可以是任意形状，并构成空腔的一部分。这种结构的实例在实际上可以发现与珊瑚或滴水石空穴结构一样。
最低限度值在这里是指凹槽、孔洞、空穴的开口，或管子开口具有大于约50微米的宽度。开口的尺寸较小会限制或抑制骨组织的生长，可能是由于营养供应被抑制，使得骨不能够连同所包括的单元按照它的正常结构发育。实际上，该物体的多孔性没有上限。上限主要是由物体的强度特性所决定的。
根据本发明，空腔可以在物体表面形成孔，这些孔彼此相邻，并具有敞开的表面孔，使得在一个物体表面的孔形成一个空腔，或者与其它物体的表面孔相通的管道/通路。
根据本发明，还发现当使用这种材料用以修复、加强或替代天然骨时，易碎的生物相容性材料，如羟基磷灰石不是用于本发明目的的最佳材料。当经受负载，例如，当装有生物相容性物体，例如颗粒的人体或人体的某一部分经受负载，例如过度运动时，这种材料容易分解，这是难免会发生的。生物相容性材料物体的分解的部分引起令人不适的炎性反应，这将抑制骨的形成，并经常会导致骨的再吸收。
因此，根据本发明，选用金属材料或不易碎成分，在多孔体材料中可包括诸如羟基磷灰石、生物陶瓷等天然材料作为其中的成分，还可包括另一种成分，例如塑料，以增强其可塑性。根据本发明的该物体材料实际上应该是可塑的或基本无弹性的材料。弹性过度会压迫骨组织，引起骨组织破坏。
钛(二氧化钛)是优选的金属材料。钛体的多孔性通过向熔融的钛吹气而很容易获得。这使得可以生产如SE-B-462,638中所提的钛粒。
然而，如上所述的关于对多孔性的要求，不是通过向熔融的金属吹气就可以自然令人满意的。因此，根据本发明，对以这种方式制备的物体/一个颗粒/多个颗粒的多孔性进行了检验，以保证它/它们满足了要求。可利用荧光镜，以适当的波长，和TV接收器以及自动分离(例如从传送带)不满足上述要求的颗粒来进行核查。
对于骨组织上述限度值＞约50微米。如果需要结缔组织而不是骨组织的向内生长或损害骨组织，则限度值改为＞约50-10微米。
根据本发明的一种多孔体，例如颗粒可植入到活体，例如人体内，在体内骨组织生长后，作为替代物填充骨腔，也可植入到病腿(风湿病、骨质疏松症)内或用于固定根据SE-B-462,638的假体。根据本发明的多孔体还可作为体外预培养骨组织的基板，或在体外用含有其它物质，例如生长因子的营养液填充，用于之后的植入到活体组织。在用于填充骨腔的情况下，优选该物体是颗粒或不规则体，具有小于10毫米的大小，从而使多个和许多颗粒最佳填充到骨腔。
多孔体可以用可降解材料，例如被称为天然材料的基质填充。这种天然材料的实例是胶原、纤维蛋白、淀粉和透明质酸的凝胶。根据本发明，这种基质被降解后由向内生长的骨组织替代。如果在这种可降解材料中加入生长-刺激物质，首要的是诸如TGF-β(转化生长因子-β)或BGF(骨生长因子)则更可以刺激骨组织向内生长。根据本发明的物体中的孔，在该材料准备凝胶化之前，可以用凝胶材料，例如通过抽吸而移动。
根据本发明的较小的物体、颗粒可以包裹在一个柔性的或刚性的外壳内，用于生产植入体。例如，根据本发明的颗粒可以包裹在刚性套管内，从而与套管一起形成脊骨植入体，可以参见US-A-5,015,247中的封套。在SE-B-9803078-6中描述了包裹在外壳里的其它可能性。外壳具有开孔以使得生物细胞材料向或从颗粒向内生长并生长穿过外壳。根据本发明的颗粒可以与可降解生物组织混合。
本发明的实施方案在附图中显示，这些图是电镜图像，其中图1显示了根据本发明的多孔结构，图2显示另一个根据本发明的钛粒外表面的多孔结构。图3是具有本发明的多孔性的钛粒的薄切片图像。所有图像都是用SE-B-462,638中详细描述的振动技术由已经从植入到人体的大腿中后取出的不规则颗粒或珠粒拍摄的。
图1显示以一堆石头形式的结构，图2显示珊瑚形式的结构。该结构是通过向熔融的钛吹气形成的，并使用上述方法进行质量检验。两个图像都显示活体材料，骨组织的前期的灰白色膜，它覆盖颗粒的外表面，并穿入钛粒的孔中的空腔和间隙。图1还显示了骨细胞生长桥联了结构中的腔/间隙。
图3显示互相交叉、穿透本发明的颗粒的骨组织。
临床分析证明在根据图1-3的颗粒中的骨组织的成分中有95-98％的骨，2％骨髓和0-3％结缔组织，这基本上与颗粒外部附近的骨组织成分相同。

Claims (13)

1.一种植入体，用于提供骨组织和/或结缔组织向内生长和生长，所述植入体由可塑的或基本无弹性的生物相容性材料构成，其特征在于它是多孔的，并具有下列多孔性特征：
-多孔是连续的
-空腔/凹槽/孔洞和使它们互联的管道/通路的开口对于骨组织具有大于50微米的宽度，而对于结缔组织具有的宽度大于10微米。
2.权利要求1的植入体，其特征在于它是不规则颗粒或珠粒。
3.根据权利要求1或2的植入体，其特征在于它是由钛构成的。
4.根据权利要求1或2的植入体，其特征在于它的空腔填充有可降解材料。
5.权利要求4的植入体，其特征在于可降解材料是天然材料基质。
6.权利要求5的植入体，其特征在于天然材料基质是胶原、纤维蛋白、淀粉或透明质酸的凝胶。
7.根据权利要求4或5的植入体，其特征在于可降解材料含生长-刺激物质。
8.根据权利要求3的植入体，其特征在于它具有珊瑚样结构。
9.根据权利要求3的植入体，其特征在于它小于10毫米。
10.根据权利要求3的植入体，其特征在于它由许多单个的不规则颗粒聚集而成。
11.一种用于制造如权利要求1-10中任意一项的植入体的方法，其特征在于这种由金属构成的植入体是通过下列步骤制备的：向熔融的金属吹气，并分离其空腔/凹槽/孔洞以及连接它们的管道/通路的开口小于50微米宽度的植入体。
12.在有开口/孔的外壳内的如权利要求10的植入体用于生产脊骨植入体的用途。
13.如权利要求12的用途，其中的外壳是刚性圆柱形套管。
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MXPA01010958A (es) 2003-06-30
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US7553539B2 (en) 2009-06-30
HK1047056A1 (en) 2003-02-07
EP1187641B1 (en) 2008-08-13
NO323629B1 (no) 2007-06-18
US20070003752A1 (en) 2007-01-04
KR20020009600A (ko) 2002-02-01
CN1356914A (zh) 2002-07-03
EP1187641A2 (en) 2002-03-20
HK1047056B (zh) 2006-02-24
PL351170A1 (en) 2003-03-24
BR0010152B1 (pt) 2013-07-09
US7056577B1 (en) 2006-06-06
IL146089A0 (en) 2002-07-25
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AU763045B2 (en) 2003-07-10
JP5042410B2 (ja) 2012-10-03
AU4446600A (en) 2000-11-10
ES2308980T3 (es) 2008-12-16
PL202374B1 (pl) 2009-06-30
BR0010152A (pt) 2002-10-08
NO20015279L (no) 2001-10-29
CA2370724A1 (en) 2000-11-02
RU2222290C2 (ru) 2004-01-27
KR100879424B1 (ko) 2009-01-19
DE60039871D1 (de) 2008-09-25
JP2002541984A (ja) 2002-12-10
ZA200108483B (en) 2002-12-24
IL146089A (en) 2007-03-08
SE515227C2 (sv) 2001-07-02
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SE9901523L (sv) 2000-10-29

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