CN1290182A - 骨移植体及其制造方法 - Google Patents

骨移植体及其制造方法 Download PDF

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Publication number
CN1290182A
CN1290182A CN99802728A CN99802728A CN1290182A CN 1290182 A CN1290182 A CN 1290182A CN 99802728 A CN99802728 A CN 99802728A CN 99802728 A CN99802728 A CN 99802728A CN 1290182 A CN1290182 A CN 1290182A
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CN
China
Prior art keywords
bone
bone graft
graft
derived elements
ossein
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Pending
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CN99802728A
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English (en)
Inventor
托德·M·博伊斯
艾伯特·曼里克
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Osteotech Inc
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Osteotech Inc
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Publication date
Application filed by Osteotech Inc filed Critical Osteotech Inc
Publication of CN1290182A publication Critical patent/CN1290182A/zh
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Abstract

本发明涉及一种由骨衍生元素的致密集合体制成的骨移植物,其中,骨衍生元素在其临近的表面暴露的骨胶原之间具有化学键。还说明了多种可以加入到骨移植物中的其它成分,例如骨生长诱导物;还介绍了一种制造方法。

Description

骨移植体及其制造方法
技术领域
本发明涉及一种骨移植体，用于修复、替换和／或加强人或者动物骨髂系统的各部分，并且涉及制造这种骨移植体的方法。更具体地，本发明涉及一种由骨衍生元素的致密集合体构成的骨移植体，其中，骨衍生元素通过在其表面暴露的骨胶原间形成的化学键相互连接。
现有技术描述
在人类医学和兽医学中使用自体移植骨、同种异体移植骨或者异种移植骨已为公知。见stevenson等人于1996年编写的《临床整形外科及相关研究》(Clinical Orthopedics and Related Research)323卷66-74页。特别是，移植骨已知用于提供支撑、促进愈合、填充骨腔、分离如脊椎体之类的骨元件、促进融合和固定骨折位置。近来，经加工的骨被做成各种形状以用于新的外科用途，或作为历史性地用非生物衍生材料构成的移植体的新材料。
美国专利No．4，678，470公开了一种非分层的骨移植物，该材料是由骨经过包括用戊二醛鞣化在内的工艺制成的。骨可以被研磨成粉、作为大块使用或加工成精巧的形状使用。鞣化使材料稳定，并使之无抗原性。骨材料还可以被去除矿物质。
骨胶原是一种自然产生的结构性生物材料，是包括骨在内的结缔组织成分之一，存在于一切脊椎动物之中。天然骨胶原是排列成三链螺旋的富甘氨酸的氨基酸链，可以用各种方法交联。
组织转谷氨酰胺酶据记载能够有效地增加软骨和软骨接合面的粘着强度。见Jurgensen，K．等人于1997年编著的《骨和关节外科期刊》(Journal ofBone and Surgery)，79-A(2)，185-193。
美国专利No．5，507，813公开了一种由伸长骨颗粒形成的可外科移植的片材，包含生物适应性成分，胶合剂、填充料及塑化剂等，可选去除矿物质。
美国专利No．4，932，973公开了一种人造有机骨基质，带有伸入到有机骨基质内的孔或穿孔。随着植入骨基质，孔或穿孔作为引导软骨和骨组织的中心。
美国专利No．4，394，370公开了一种单片的海绵状的骨移植物，由完全去除矿物质的骨粉或微骨以及重新构造的骨胶原制成。可选地，海绵状移植体用戊二醛交联。
美国专利No．5，683，459公开了另一种单片的多孔移植物。该移植物由一种具有互连的开口网构造的可生物降解的聚合宏观结构，和一种由如透明质酸之类的趋化性基质构成的可生物降解的聚合微观结构构成。
发明概述
本发明提供一种骨移植物，由于在制造此骨移植物的部分去除矿物质的相邻的骨元素的表面暴露的骨胶原之间形成化学键，因此该骨移植物表现出良好的机械强度，具有生物适应性。另外，在一个优选实施例中，由于其具有骨愈合活性并含有骨生长诱导物，因此可以促进和／或加速新骨的生长。
因此，本发明的一个目的是提供一种由骨衍生元素的致密集合体构成的骨移植物，相邻的骨衍生元素通过其表面暴露的骨胶原之间的化学键相互联接，并且所述骨移植物具有良好的机械强度和生物适应性。
本发明的另一个目的是提供一种骨移植物，它可选地包括另一种成分，如增强颗粒或纤维、填充料、如医用／外科用物质等骨生长诱导物，及它们的组合。
本发明的又一个目的是提供一种骨移植物，具有孔、穿孔、缝隙、通路或空间的网络，该网络允许并促使内生和外生的骨愈合材料以及血液供给的渗透，并同时提供一个用于加入一种或多种骨愈合物质的装置。
本发明的再一个目的是提供一种骨移植物，它可以被做成各种形状和尺寸，且不受可用于构成骨移植物的施主的骨的尺寸和／或类型的限制。
本发明还有一个目的是提供一种制造方法，它能够提供一种坚固的，具有生物适应性的，并具有任何用于移植的尺寸和／或形状的骨移植物。
为了与本发明的这些和其它目的相一致，本发明提供了一种骨移植物，它包括骨衍生元素的致密集合体，相邻的骨衍生元素通过其表面暴露的骨胶原之间的化学键互相联接。
为了与本发明一致，还提供了一种制造骨移植物的方法，包含提供一些呈现表面暴露的骨胶原的骨衍生元素，并且在表面暴露的骨胶原之间形成化学键，从而将元素联接成致密的集合体。
相对于现有技术来说，本发明的骨移植物在其生物适应能力、非抗原性和提供良好机械强度方面具有显著的优点。
相对于现有技术的移植物来说，本发明的骨移植物的另一个重要优点在于：它能够作为一种或多种促进新骨生长和／或加速愈合的骨生长诱导物的载体，并使之有效地扩散。
本文所用的术语“成骨性”应当理解为，一种物质通过活细胞从该物质内部参与而促使新骨生成的能力。
本文所用的术语“骨导通性”应当理解为，一种物质或者材料提供能被新的主体骨生长所接受的生物惰性表面的能力。
本文所用的术语“骨诱导性”应当理解为，一种物质具有从主体骨中征集有修复骨组织能力的细胞的能力。
本文所用的表述语“骨衍生元素”应当理解为，各种尺寸、厚度和结构的骨件，包括颗粒、纤维、条、和厚薄不一的片等，它们可以通过对整个骨头进行研磨、切片、切割或者机加工得到。
本文所用的表述语“表面暴露的骨胶原”应当理解为，对上述骨衍生元素去除矿物质所得到的结果，去除矿物质的范围是从基本上全部的(这时骨衍生元素主要是骨胶原)到局部的或表面的(这时只有骨衍生元素的表面显露出暴露的骨胶原)。局部或表面去除矿物质产生具有表面接合区的骨衍生元素，即，保持强化区的暴露骨胶原，即，骨衍生元素的未受矿化影响的区域。
下面参照附图说明各个实施例，其中：
图1是沿纵向被切成几个坚质骨片的骨干区的骨截面图；
图2是本发明的骨移植物的放大透视图，骨移植物的表面为局部去除矿物质的骨的片层，内部由矿物化或局部去除矿物质的骨构成；
图3是人体股骨的示意图，如图3A所示，展示了本发明的制作成股骨替换物的骨移植物；
图4是人体脊柱的局部示意图，展示了安装在椎间位置的本发明的盘状骨移植物；
图5和5A是人体颅骨的示意图，展示了制作成颅骨置换物的本发明的骨移植物；
图6是本发明的骨移植物的放大透视图，具有骨片的交互层和其间带有通道的立方体；
图7是人体脊柱的局部示意图，展示了在后外侧横突间的融合位置安装图6所示的骨移植物；和
图8A是具有骨片层的本发明的骨移植物的放大透视图，如图8所示，骨片层通过由组织转谷氨酰胺酶催化形成的化学键联接在一起。
优选实施例描述
本发明的骨移植物包括骨衍生元素的致密集合体，在其表面暴露的骨胶原分子之间具有化学键，从而把相邻的骨元素相互联接。为了露出位于骨外表层的骨胶原，骨成分必须至少部分地去除矿物质。去除矿物质方法用酸溶液去除骨内的矿物质成分。本发明所用的这种方法已为本领域所公知，例如见Reddi等人于1972年编著的Proc．Nat．Sci．69，1601-1605页，在此引为参考。酸溶液的浓度、骨的形状以及去矿处理的时间长短将决定去除矿物质的程度。关于这方面，可以参见Lewandrowski等人于1996年编著的J．Biomed Materials Res，31，365-372页，也在此引作参考。此处的骨衍生元素的来源包括坚质骨和松质骨，优选同种异体来源，但也可以包括异种来源，例如牛骨和猪骨。
当骨移植物由仅对表面去矿处理的骨衍生元素制备时，可具有相当高的抗压强度，例如，接近于天然骨的抗压强度。因此，当期望骨移植物表现出相对高的抗压强度时，例如，相当于大约10至200MPa，优选从20至100Mpa，有必要使骨衍生元素中的原有矿物成分保持较高比例，换言之，只经过表面去矿处理。
除了含有骨衍生元素之外，可选地，本发明的骨移植物还可以具有一种或多种其它成分，例如增强颗粒、纤维、填充料、骨生长诱导物、胶合剂、塑化剂、柔化剂、水合助长剂、生物抑制剂／杀虫剂、辐射不透性物质、金属网及诸如此类。增强颗粒的例子包括完全矿化的坚质骨和松质骨，和部分去矿化的坚质骨和松质骨，它们可以是任何形式的，包括颗粒、片和成型的骨块；石墨或者热解碳。填充材料的例子包括羟磷灰石、磷酸三钙和其它钙盐之类的矿物质，骨粉，完全矿物质的和部分或者完全去除矿物质密质和松质骨，可以是任何形状，包括去除矿物质的骨粉(或者有人称之为的“去除矿物质骨基质”之类的颗粒、片和成型的骨件、石墨或热解碳。填充料的例子包括矿物材料，例如羟磷灰石、磷酸三钙、和其它钙盐，骨粉、全部矿化和局部或全部去矿化的坚质骨和松质骨，它们可以是任何形式的，包括颗粒，例如去矿化的骨粉(也可以称之为“去矿化骨基质”)，片和成型骨件，石墨或热解碳，生物玻璃或其它生物陶瓷或天然或合成的聚合体，例如聚乙交酯、聚交酯、乙交酯-丙交酯的共聚物及诸如此类的生物可吸收聚合物，和淀粉、聚甲基丙烯酸甲酯、聚四氟乙烯、聚亚安酯、聚乙烯和尼龙之类的非生物吸收材料。适合的塑化剂、柔化剂和水合助长剂包括液体多羟基成分，如甘油、一醋精、二醋精及其混合物；适合的生物抑制剂／生物杀灭剂包括抗生素、聚烯吡酮、糖及其混合物；适合的表面剂包括生物适应性的非离子的、阳离子的、阴离子的和两性的表面活性剂及其混合物。骨移植物还可以具有骨生长诱导物，包括下面所述的任何医用和／或外科用物质。
骨移植物可以具有一个或多个空腔，如果需要，它们可以通过为此目的专设的，平均直径范围从几个微米至几个毫米的孔、缝隙、穿孔或通道与移植物的表面连通。在这些空腔及相关的孔、缝隙、穿孔或通道中可以部分地或全部地填入一种或多种医用／外科用物质，这些物质由于例如成骨性、骨导通性和／或骨导通效果促进或加速新骨的生长或骨愈合。可以被加入到本发明的骨移植物中的这类物质包括，例如骨胶原、不可溶的骨胶原衍生物等，和溶解在其中的可溶性固体和／或液体，例如抗病毒剂，尤其是那些对HIV和肝炎病毒有效的抗病毒剂；抗微生物和／或抗生素，例如红霉素、杆菌肽、新霉素、青霉素、多粘菌素B、四环素、紫霉素、氯霉素和链霉素，头孢霉素v、氨比西林、阿茶克坦、妥布霉素、庆大霉素等；杀生糖／生物抑制糖，例如右旋糖、葡萄糖等；氨基酸、肽、维生素、无机元素、蛋白合成辅酶；激素；内分泌组织或者组织片段；合成剂；酶，如胶原酶、肽酶、氧化酶等；带有实质细胞的聚合细胞骨架；成血管药物和含此类药物的聚合物载体；胶原格阵；抗原剂；细胞骨架剂(cytoskeletalagents)；软骨片段，软骨细胞、骨髓细胞、间叶干细胞(mesenchymalstem cells)之类的活细胞，天然提取物、组织移植物、骨、去矿的骨、血、血清、软组织、骨髓等；生物胶合剂、骨成型蛋白(BMPs)、变异生长因子(TGF-beta)、类胰岛素生长因子(IGF-1)；生长激素，例如生长激素；骨消化素；抗肿瘤剂；免疫抑制剂；成血管剂，例如基础纤维原细胞生长因子(BFGF)；助渗剂，例如脂肪酸酯、月桂酸酯、肉豆蔻酸酯和聚乙二醇单硬脂酸酯、烯胺衍生物、阿尔法-酮醛等；和核酸。这些及类似的医用／外科用物质可以在组装移植体的任何阶段引入到本发明的骨移植物中，或引入任何构成其的骨衍生元素中或其它成分中。适当的引入方法包括覆层、饱合浸泡、包裹等。医用／外科用物质的用量选择余地很广，通过常规的试验很容易确定其最佳值。
例如，通过机加工或如压模等其它机械成型操作，可以提供任何所需尺寸和／或结构的骨移植物。可以对特殊的移植物进行计算机建模，随后再对移植物进行计算机成型控制，以提供形状复杂的骨移植物，该移植物能以极高的精确性象定做般地固定在预期的位置。
当本发明包含加长的骨衍生元素的集合体，在外观上可以用细丝、纤维、线、细长的或窄条等来描述时，这些成分可以通过多种方法形成骨移植物。例如，可以在适当的媒质中形成溶液或浆液，所述媒质可以包含交联剂，和任一比例的部分或完全去矿化的和完全矿化的加长骨衍生元素。此溶液能够根据浇注模具的构造形成任意形状的骨移植物。优选地，将模具做成骨状或其片段的形状，或做成用于移植的移植物的形状。一旦注入模具，可以通过公知的技术将骨衍生元素溶液固化成固体骨移植物。
例如，通过增加机械紧固件，如销钉、螺钉、榫钉等，补充或增加骨移植物的形状保持和／或机械强度特性，这也包括在本发明的范围内。上述机械紧固件可以通过采用激光组织焊接或超声波焊接等方法，用天然或合成材料以及生物可吸收和非生物可吸收材料制成。在那些用片等相对较大的骨衍生元素组装成骨移植物的实施例中，这些元素可以具有机械互啮特性，例如，凹凸槽或公母榫特性，这有利于其最终成品的组装和／或把这些元素以更牢固的方式固定。
本发明的骨移植材料旨在用于骨缺损处，例如，受伤的骨头、外科手术过程中带来的缺损、感染、恶性肿瘤及发育畸形。具有适当尺寸和所需形状的骨移植物可以用于整形外科、神经外科、口腔科及上颌面外科的各种移植或置换，例如简单或有创骨折和未接合的修复、内部和外部固定、关节重建，例如关节固定术、普通关节造形术、臀部的杯关节成形术、股骨和肱骨头置换术、股骨头表面置换术和全关节置换术，脊柱修复，包括脊柱融合术和内部固定，肿瘤手术，例如，缺失填充、椎间盘切除、椎板切除、脊髓肿瘤切除、前颈和胸部手术，脊椎损伤修复、脊柱侧凸、脊柱前弯和驼背的治疗，骨折外侧固定、颏成形术、颞下颌关节置换术、牙槽嵴增高术和重建术、外置内骨移植、移植物定位和修正、窦道整平等。可以用本发明的骨移植物修复或置换的特殊骨还包括筛骨、额骨、鼻骨、枕骨、顶骨、颞骨、下颌骨、上颌骨、颧骨、颈椎骨、胸椎骨、腰椎骨、骶骨、肋骨、胸骨、锁骨、肩胛骨、肱骨、桡骨、尺骨、腕骨、掌骨、指骨、髂骨、坐骨、耻骨、股骨、胫骨、腓骨、髌骨、跟骨、跗骨和跖骨。
本发明的骨移植物制造方法包含：提供一些骨衍生元素，它们开始表现出表面暴露的骨胶原，随后在邻近骨衍生元素的表面暴露的骨胶原之间形成化学键以将这些元素联结为致密集合体。这些化学键可以通过多种公知方法形成，包括化学反应、使用例如放射能等能量，包括放射UV光或微波能，干燥和／或加热和染料介质光氧化(die-mediated photo oxidation)；通过把骨组织放在真空下缓慢去除水分进行热脱氢处理；和在任何骨胶原-骨胶原的接合部位形成化学键的酶化处理。化学反应为优选的形成化学键的方法。
化学交联剂包括那些包含有两种或多种功能的反应基的，并与氨基酸上的功能团反应的化学交联剂，例如与赖氨酸或羟基赖氨酸的厄普西隆功能团反应，或与天冬氨酸和谷氨酸的羧基功能团反应。通过与相同或不同的骨胶原分子上的多功能基反应，起反应的化学交联剂形成增强的交联桥。
适合的化学交联剂包括单醛和二醛，包括戊二醛和甲醛；聚环氧化合物，如甘油聚甘油醚、聚乙二醇二甘醚和其它聚环氧和二环氧甘油醚；鞣剂包括二氧化钛、二氧化铬、二氧化铝、锆盐在内的多价金属氧化物，以及有机鞣酸和其它由植物中提取的苯酚氧化物；用于羟基酯化反应的化学药品，随后通过与酰肼反应在骨胶原中形成活化的重氮化酰功能根；双环己基二亚安碳及其衍生物以及其它的异构双功能交联剂；二异脯酸己二酯；包括葡萄糖在内的糖也可以交联骨胶原。
戊二醛交联生物材料在体内具有过钙化的趋势。在这种情况下，有必要将钙化控制剂与醛交联剂一起使用。这些钙化控制剂包括：二甲基亚砜(DMSO)，表面活性剂、二磷酸盐；氨基油酸，和金属离子，例如铁离子和铝离子。这些钙化控制剂的浓度可以由本领域的技术人员通过常规试验确定。
化学交联包括把表现出表面暴露的骨胶原的骨衍生元素暴露在化学交联剂中，即可以将这些元素放置在化学交联剂的溶液中，也可以在适于特定类型的交联反应的条件下，把它们暴露在化学交联剂的蒸汽中。所述的条件包括适当的PH值和温度，时间从几分钟到几天，这要取决于所需的交联程度和化学交联剂的活性。然后清洗骨移植物以去除所有可滤去的化学药品的痕迹。
在使用酶化处理时，可用的酶包括本领域所公知的能够对蛋白或肽的，优选对骨胶原分子的，交联反应起催化作用的酶。如在Jurgensen等人于1997年编著的《骨和关节外科期刊》(Journal of Bone andSurgery)，79-A(2)，185-193页中所描述的转谷氨酶，在此引作参考。
还可以通过施加能量形成化学键。一个通过施加能量形成化学交联的方法是采用已知的方法形成由大气产生的高活性氧离子，而它反过来又促进表面暴露的骨胶原之间的氧交联。这种方法包括采用紫外光形式的能量、微波能量和诸如此类。另一种施加能量的方法是一种称作染料介质光氧化的工艺，其中一种化学染料在可见光的作用下用作交联表面暴露的骨胶原。
另一种形成化学键的方法是脱氢热处理，其优选在真空中，使用结合热缓慢去除水分，以达到骨衍生元素的交联。此工艺包括把一个骨胶原分子的功能团的一个羟基团与另一个骨胶原分子的功能团的一个氢离子结合，反应生成水，去掉水后在胶原分子之间形成键。
参见附图，如图1所示，通过纵向切片将由骨干区截取的骨10的坚质部分切成了具有不同宽度的坚质骨片11。如果希望，坚质骨片11可以进一步被切成统一的尺寸和形状，如图2所示的骨移植物20的骨衍生片21。
图2图解了一种骨移植物20，其包括：具有全部或局部去矿的外表面的坚质骨衍生片21，和未去矿或局部去矿的核心22，其中所述外表面带有表面暴露的骨胶原。可选地，一个或多个骨衍生片可由完全去矿的骨制成。另外，另一种成分，例如去矿的骨粉可以被涂覆在骨衍生片上。整个结构在相邻的骨衍生片上具有交联的骨胶原，以增加它们之间的附着力。骨移植物的总厚度通常至少为2至20mm。骨移植物20可以被切割、机加工和／或其它方法形成所希望的任何其它形状或尺寸，以用于体内移植。因此，如图3A所示，可以制成大致为圆柱形的骨移植物30，用作图3中股骨32的长骨段的置换物31。为形成圆柱形，可以在车床上把大致为方形或矩形的骨移植物加工到所需的直径。可以通过例如用钻去除骨材料以形成空腔，或可选地，也可以通过组装适当结构的骨衍生元素层形成空腔。
如图4所示，盘状的骨移植物40被插入脊柱42前侧上的椎间纤维软骨位置。
在图5中，加工出顶骨骨移植物50的尺寸和形状，以构成图5A所示的颅骨51的顶骨的一部分。
图6中，骨移植物60由表面去矿的坚质骨的骨衍生片部分61，和具有方形截面的、表面去矿的松质骨的骨衍生立方体部分62形成。如图所示，这些片和立方体组成部分设置在交叠的层中。组装后，对此结构进行交联处理。通道63的存在导致骨移植物具有开口结构，因此，该骨移植物允许血管穿过，或主体骨在其内生长，和／或一种或多种医用／外科用物质从中扩散。骨移植物60安装成脊椎覆盖移植物，通过将横突71插入通道63中进行连接，用于图7所示的脊柱70上的外后侧横突接合。
图8A中，骨移植物80包括：具有完全或局部去矿的外表面的骨衍生片81。如图8所示，骨衍生片一侧涂有组织转谷氨酰胺酶83，并且相邻片的配合面涂有Cacl2溶液82。在骨移植物80组装时，骨衍生片的两个互补侧之间的接触使得组织转谷氨酰胺酶83对相邻骨衍生片81接合处的骨胶原交联进行催化。
以下各例进一步说明本发明的骨移植物。例1
不断用水湿润的同时，把从骨干区得到的骨坚质部分用金刚石刀片锯沿纵向锯成大约1．5mm厚的片。把坚质骨衍生片冷冻到-70℃并冷冻干燥48小时，随后，再将其放入超过0．6N的HCL溶液中持续1．5小时并不断搅拌，在水中清洗5分钟，然后在BupH磷酸盐缓冲盐水中浸泡1．5小时。把骨衍生片组装成分层的结构，并用夹具固定。把卡固好的结构置入10％的中性、缓冲福尔马林溶液中48小时，以交联暴露的骨胶原表面。在交联后，取走夹具，然后把所述结构放进一个容器使之在流动的水中漂洗几个小时。用带锯把骨移植物锯成型，然后放进甘油的过量水溶液中。几个小时后，去掉过量溶液，然后对骨移植物进行冷冻干燥。例2
由坚质骨磨制成细长的骨衍生纤维，然后在过量的0．6N盐酸溶液中完全去除矿物质。用水清洗这些纤维，并把它们浸入到甘油的水溶液中。另外，把完全矿化的骨衍生纤维加入到在室温下搅拌并放置12个小时的溶液中。
把浸泡矿化和去除化骨衍生纤维的溶液经106微米的筛子浇注以恢复纤维。矿化和去矿化纤维的混合物被放入一个圆柱形的冲模中，然后在10，000至50，000psi的压力下加压处理15分钟，然后在37至55℃下加热2至12小时。将得到的骨移植丸冷冻干燥，然后放进聚乙二醇二甘醚中在室温下放置12个小时。例3
由人类坚质骨得到的骨衍生片，大约1mm厚，7mm宽，50mm长，在0．6N的HCL溶液中处理10分钟以暴露表面骨胶原。对10mm×10mm的由人类松质骨得到的骨衍生立方体进行处理，在立方体的外边沿暴露表面骨胶原。把所有的骨衍生片和立方体在水中清洗。把这些骨件组装在一起，骨衍生片与立方体邻接，并夹固在位。把所得结构置入10％的中性、缓冲福尔马林溶液中3小时，以交联表面暴露的骨胶原。将得到的骨移植物用水清洗，然后在带锯上锯成所需尺寸，见图6。例4
大约1mm厚的人类坚质骨衍生片在0．6N的HCL溶液中去除矿物质15分钟，然后在流动的水中清洗。将组织转谷氨酰胺酶配制成1mg／ml的溶液。对于结构中的每个去矿骨衍生片，把表面吸干，然后在一侧施加40μl／cm2的组织转谷氨酰胺酶，并在下一个去矿化骨衍生片的配合面上施加等量的0．1M的Cacl2溶液。然后重复该过程。将得到的骨移植物夹住并放入恒湿室中30分钟以促进交联，然后用水清洗。例5
大约2毫米厚的坚质骨衍生片在0．6N的HCL溶液中表面去矿1小时，并不断搅拌。然后在骨衍生片上涂覆干燥的、粒度300微米或更低的去矿骨粉，并组装成叠层。将此结构夹卡在位，然后置入10％的中性缓冲福尔马林溶液中12小时，以便骨胶原交联。用水清洗得到的骨移植物以去除过量的化学药品。

Claims (27)

1．一种骨移植物，包含：骨衍生元素的致密集合体，相邻的骨衍生元素通过其表面暴露的骨胶原之间的化学键相互联接。
2．权利要求1所述的骨移植物，其特征在于，所述骨衍生元素为表面去除矿物质的同种异体、异种的坚质和／或松质骨的颗粒、条或片。
3．权利要求1所述的骨移植物，其特征在于，所述骨衍生元素为基本上完全去除矿物质的同种异体、异种的坚质和／或松质骨的颗粒、条或片。
4．权利要求1所述的骨移植物，其特征在于，至少包含一种其它成分。
5．权利要求4所述的骨移植物，其特征在于，所述其它的成分选自包括增强颗粒或纤维、填充料、骨生长诱导物、生长因子、完全去矿的同种异体或异种的骨、多孔材料、遗传物质、钙化控制剂、水合作用剂、无机成分和聚合物的组合。
6．权利要求1所述的骨移植物，其特征在于，至少在其长度的一部分上，具有近似圆形、椭圆形或多边形的截面，可选地，至少在移植物长度的一部分上，具有一个空腔。
7．权利要求1所述的骨移植物，其特征在于，构造为移植体。
8．权利要求1所述的骨移植物，其特征在于，构造为骨或其片段的置换物。
9．权利要求8所述的骨移植物，其特征在于，构造为椎间插入物、长骨、头盖骨、盆骨、手脚或其片段的骨。
10．权利要求1所述的骨移植物，其特征在于，所述化学键可以通过化学交联、施加能量、脱氢热处理或酶处理形成。
11．权利要求1所述的骨移植物，其特征在于，所述骨移植物具有大约10至200Mpa的抗压强度。
12．权利要求1所述的骨移植物，其特征在于，所述骨移植物具有大约20至100Mpa的抗压强度。
13．权利要求1所述的骨移植物，其特征在于，所述骨移植物具有助水合作用剂。
14．权利要求1所述的骨移植物，其特征在于，所述的助水合作用剂为甘油。
15．一种制造骨移植物的方法，它包括：
a)提供一定量的开始表现出表面暴露的骨胶原的骨衍生元素；和
b)在相邻的骨衍生元素的表面暴露的骨胶原之间形成化学键，以将所述元素联接成一个致密集合体。
16．权利要求15所述的方法，其特征在于，所述骨衍生元素为基本上完全去除矿物质的同种异体和／或异种坚质骨的颗粒、条或者片。
17．权利要求15所述的方法，其特征在于，所述化学键可以通过化学交联、施加能量、脱氢热处理、酶处理或上述的任意组合形成。
18．权利要求15所述的方法，其特征在于，该方法在模具中进行。
19．权利要求18所述的方法，其特征在于，模具的成型表面将骨移植物构造成骨或其局部的形状。
20．权利要求18所述的方法，其特征在于，模具的成型表面将骨移植物构造成椎间插入物、长骨、头骨、盆骨、手脚或其片段的骨的形状。
21．权利要求17所述的方法，其特征在于，化学键可以通过骨衍生元素与化学交联剂的接触形成，以便在相邻的骨衍生元素的表面暴露的骨胶原之间形成化学键。
22．权利要求21所述的方法，其特征在于，化学交联剂选自单醛、二醛、聚环氧化合物、多价金属氧化物、有机鞣酸、苯酚氧化物、糖、双环己基二亚安碳和二异脯酸己二酯的组合。
23．权利要求17所述的方法，其特征在于，通过在气态环境中辐射骨衍生元素以提供氧离子，其后氧离子与相邻的骨衍生元素的表面暴露的骨胶原进行反应，在其间形成化学键。
24．权利要求17所述的方法，其特征在于，所述化学键通过染料介质光氧化作用形成。
25．权利要求17所述的方法，其特征在于，脱氢热处理包括加热骨衍生元素以去除其中的水分，和去除水分。
26．权利要求17所述的方法，其特征在于，所述化学键通过用酶处理骨衍生元素形成，其中，酶催化相邻的骨衍生元素的表面暴露的骨胶原的氨基酸功能团之间的化学键形成。
27．权利要求26所述的方法，其特征在于，所述酶为组织转谷氨酰胺酶。
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US6123731A (en) 2000-09-26
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JP2002502637A (ja) 2002-01-29
HUP0102991A2 (hu) 2001-11-28

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