CN1819806A - 融合植入物及其制造方法 - Google Patents

融合植入物及其制造方法 Download PDF

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Publication number
CN1819806A
CN1819806A CNA2004800196280A CN200480019628A CN1819806A CN 1819806 A CN1819806 A CN 1819806A CN A2004800196280 A CNA2004800196280 A CN A2004800196280A CN 200480019628 A CN200480019628 A CN 200480019628A CN 1819806 A CN1819806 A CN 1819806A
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CN
China
Prior art keywords
implant
bone
flexible flat
piece
structure division
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CNA2004800196280A
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English (en)
Inventor
E·F·雷三世
W·F·麦克凯
C·R·里夫斯
T·A·西蒙敦
J·J·宾德赛勒
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Warsaw Orthopedic Inc
Original Assignee
SDGI Holdings Inc
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Filing date
Publication date
Application filed by SDGI Holdings Inc filed Critical SDGI Holdings Inc
Publication of CN1819806A publication Critical patent/CN1819806A/zh
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Abstract

本发明提供了用于融合相邻骨结构的植入物。该植入物包含至少一个结构部分(14)，它与至少一个柔性平面部分(16)结合以将至少一个结构部分固定，从而形成该植入物。

Description

融合植入物及其制造方法
发明背景
用于融合相邻骨结构的植入物通过将相邻骨结构维持在预定间隔关系中使骨在它们之间生长而帮助融合。在一些情况下，这些植入物是由身体组织形成的。在从身体组织形成植入物过程中，将组织来源，如骨，形成满足具体植入物所需的形状和强度要求的块。在骨的情况下，该要求常常被具体描述为最小壁厚度、最小负荷承载容量和/或几何大小和形状。源组织的一部分，包括在形成植入物中去除的部分，将达不到形成完整植入物的要求。因此，常常难以从特定的来源获得高产率。
发明概要
本发明提供了用于融合相邻骨结构的植入物。
在本发明的一个方面，一种用于融合相邻骨结构的植入物包含至少一个结构部分，它与至少一个柔性平面部分结合以固定该至少一个结构部分形成植入物。
在本发明的另一方面，一种用于融合相邻骨结构的负荷承载植入物包含多个骨块和一个柔性平面部分，该部分含有骨块，使植入物形成预定形状。
在本发明的另一方面，一种用于融合相邻骨结构的负荷承载植入物包含多个骨块和一个柔性平面部分，骨块和柔性平面部分形成交替层。
在本发明的另一方面，一种用于融合相邻骨结构的负荷承载植入物包含多个骨块和一个柔性平面部分，骨块和柔性平面部分形成交替层。
在本发明的另一方面，一种用于融合相邻骨结构的负荷承载植入物包含含有柔性平面部分的多层和至少一个结构部分，其中结构部分延伸到多层的至少两层中以将该至少一个结构部分以预定方向附着在层中。
在本发明的另一方面，一种用于融合相邻骨结构的负荷承载植入物包含将所述相邻骨结构支持在间隔关系中的负荷承载装置和将负荷承载装置固定在预定方向上的固定装置。
在本发明的另一方面，一种躯体治疗以促进相邻骨结构融合的方法包括下述步骤：提供多个骨块；将多个骨块包含在柔性平面部分中形成具有预定形状的植入物；和将植入物置于相邻骨结构之间。
在本发明的另一方面，一种用于融合相邻骨结构的系统包含多个骨块；至少一个基本上固定了多个骨块的柔性平面部分；和可与相邻骨结构连接并具有限制相邻骨结构之间相对运动的结构的固定装置。
在本发明的另一方面，一种用于融合相邻骨结构的植入物包含至少一个具有第一负荷承载容量的固定部分和至少一个具有比第一负荷承载容量大的第二负荷承载容量的结构部分，固定部分将结构部分相对于相邻骨结构固定在预定方向上。
附图简要说明
将参照附图讨论本发明的各种实施方式。这些附图仅描述本发明的示例性实施方式，并不认为是对其范围的限制。
图1是本发明示例性植入物的立体图，断开线所示的外部部分揭示该实施方的内部结构。
图2是与图1类似的植入物立体图，显示另一种形状和中空部分。
图3是与图1类似的植入物立体图，显示另一种叠积层结构。
图4是与图1类似的植入物立体图，显示另一种螺旋卷层。
图5是与图4类似的植入物立体图，显示又一类型的螺旋卷层结构。
图6是示例性实施方式图5在滚卷之前的平面图。
图7是与图1类似的植入物立体图，显示附加结构部分。
图8是与图7类似的植入物立体图，显示折叠层结构。
图9是侧视示意图，显示与补充固定装置结合的如图1-8的植入物。
发明详述
骨融合植入物的实施方式包括一个或多个结构部分和一个或多个柔性平面部分，柔性平面部分将结构部分固定以形成负荷承载植入物用于融合相邻骨结构。相邻骨结构可包括椎骨、长骨和颅骨等。柔性平面部分可将多个结构部分固定成预定的形状、间隔和/或取向。例如，柔性平面部分可包绕结构部分并将它们固定成矩形、半球状、圆柱状或其它合适形状。在此方法中，可将单独不能满足强度和/或几何形状要求的结构部分集合起来满足要求。而且，柔性平面部分可将一个或多个结构部分固定在预定间隔或方向上。例如，柔性平面部分可相对于相邻骨组织将伸长的结构部分固定成使其轴向在预定负荷承载方向上。例如，一个或多个结构部分可满足特定应用的负荷承载要求，但可能没有大到足以填充相邻骨结构之间的空间和/或保持适合的取向。柔性平面部分可将它们固定，并防止它们移出位置。结构部分可具有比柔性平面部分更大的负荷承载容量。虽然柔性平面部分固定了结构部分，但该组合在一个或多个维度中可能是足够柔软的，以适应周围身体组织。例如，该组合可适应由椎间盘纤维环确定的形状。
柔性平面部分可包含能够固定结构部分的、生物相容性的柔性结构。该柔性平面结构可包括一种、一种以上伸长的平面材料，包括天然和人造材料，或不同类型上述材料的组合。柔性平面部分可以是片材、块料、泡沫、织物、无纺织物、网、膜形式和/或其它合适的弹性形式和它们的组合。柔性平面部分可包含松质支架，如由纤维素包括羧基甲基纤维素制成的支架。柔性平面部分可由身体组织、可吸收聚合物、不可吸收聚合物、金属和/或其它合适材料及其组合制成。包括身体组织的柔性平面部分可包括筋膜、皮肤、心包膜、部分去矿化的骨、完全去矿化的骨、纤维环、软骨、腱、韧带和/或其它合适的身体组织和它们的组合。包括聚合物的柔性平面部分可包括聚乙稀、聚酯、聚乙醇酸、聚乳酸、聚芳基醚酮、聚醚醚酮、聚四氟乙烯和/或其它合适的聚合物和它们的组合。根据可能施加于融合植入物的应用和负荷，在一个维度中可采用一种类型的柔性平面部分而在另一维度中可采用不同类型的柔性平面部分。此外，柔性平面部分可包括一个或多个开口，以帮助相邻骨结构融合。例如，将这一个或多个开口的尺寸做成比结构部分小，以使柔性平面部分可以含有它们。或者，可以将固定材料如骨糊、胶原、明胶、聚合物和/或其它合适的材料插入这一个或多个开口，与一个或多个结构部分结合，将它们固定在这一个或多个开口内。而且，可将柔性平面部分环绕或置于结构部分旁边，以形成融合植入物。
该结构部分可包括能够耐受预定负荷的任意形式和任意生物相容性材料。该结构部分可以是颗粒、条或棒、块或束形。例如，束可具有圆形、矩形、“I”形、“T”形、“C”形或其它合适形状的截面形状。该结构部分可由骨、金属、陶瓷、碳和/或聚合物和它们的组合制成。如果是由骨制成，各块骨可包含皮质骨，以在植入物中达到预定的负荷承载容量。此外，各骨块或骨条可包含松质骨。而且，骨块可被去矿化、部分去矿化、完全去矿化或它们的组合。如果结构部分包括聚合物，那么它们可以是可吸收或不可吸收的，包括聚乙稀、聚酯、聚乙醇酸、聚乳酸、聚芳基醚酮、聚醚醚酮、聚四氟乙烯和/或其它合适的聚合物和它们的组合。
在具有包括骨块的结构部分的植入物中，柔性平面部分固定骨块形成骨融合植入物。因此，将多个骨块结合到由柔性平面部分固定的植入物中使具有比预定最小负荷承载容量低和/或不同于预定标准的预定几何形状的供体骨结合，形成可获得预定容量和/或几何形状的组装的骨负荷承载植入物。可根据颗粒力学确定该块的形状和尺寸分布，以进一步了解该植入物的形状保持力、负荷承载容量和/或稳定性。同样地，将一个或多个骨块定向在预定的负荷承载方向上就可使用否则不会大到足以填充相邻骨结构之间间隔或维持合适取向的骨块。
骨块可具有任意合适的长、宽和高，以及任意的几何形状。例如各骨块可具有预定的皮质骨厚度、和/或小于预定最小厚度的几何尺寸、和/或整块或多块负荷承载骨植入物的几何形状。
参见图1和2，示例性实施方式融合植入物10、12包括含有多个通过一个或多个柔性平面部分16维持成预定形状的骨块14的结构部分。预定形状可以是适合在相邻骨结构之间实现骨融合的任何形状。例如，一种融合植入物10(图1)包括基本矩形的维度，而另一融合植入物12(图2)包括部分半球形表面和盘样的维度。融合植入物10、12可位于相邻骨结构之间，以将骨结构维持在间隔关系中，并促进骨结构融合。可制备骨结构使其接受植入物，如凿、铰、磨或锯骨以适应植入物的形状和/或暴露下面的骨组织。柔性平面部分可使植入物适应骨结构形状。可改变部分半球形植入物12的形状，使其适合相邻骨结构的自然轮廓，如相邻椎体的终板。植入物形状可由一个或多个平面部分的构造确定，或者可用模具、压具或任何其它类型的成形装置将植入物10、12组装成预定形状。
多个骨14可以是任意大小、形状的块或不同大小和形状的块的组合。多个骨块14各自可独立于相邻骨块，或通过例如机械或化学机制，如销连接、缝合、压力、掺入粘合剂、胶原交联、缠结和其它合适的方法及其组合互相连接或结合。
如果将块销连接，可在块中形成孔，可将由骨、陶瓷、金属、聚合物和/或其它合适材料制成的刚性销压入孔中，使块互相连接。
如果将块缝合在一起，可在块中形成孔，可将弹性、伸长的生物相容性连接物穿过孔，将块互相连接起来。连接物可以是身体组织的缝线和/或伸长块。这些连接物的材料的例子包括心包膜、去矿化骨、筋膜、软骨、腱、韧带、皮肤、胶原、弹性蛋白、网状组织、肠粘膜下层、金属、可吸收聚合物和不可吸收聚合物和/或其它合适材料。
如果用粘合剂将块互相连接，它可以是胶性粘合剂、水泥质粘合剂和/或其它合适的粘合剂。胶性粘合剂的例子包括纤维蛋白胶、氰基丙烯酸酯、环氧树脂、聚异丁烯酸甲酯、基于明胶的粘合剂和其它合适的粘合剂及其组合。水泥质粘合剂的例子包括可凝固陶瓷、碳酸钙、磷酸钙、石膏和其它合适材料及其组合。
如果用胶原交联将块互相连接，则可将骨块部分去矿化以暴露胶原纤维，然后通过施加热、压力、化学物质和/或其它合适的交联方法可使胶原纤维交联。
一个或多个柔性平面部分16可完全包含多个骨块14，而将骨固定为预定形状。或者，在柔性平面部分中可有预定开口18，以允许多个骨块14暴露于与融合植入物10、12相邻的骨结构。预定开口18可包括一个或多个平面部分16的部分之间的预定间隔，或可包括在一个或多个平面部分中形成的开口。而且，参见图2，一个或多个预定开口18可包含延伸到整个植入物12中的内壁20。内壁20可通过一个或多个柔性平面部分并通过多个骨块14而形成。例如，开口18和内壁20(图2)可通过但不限于钻、切或冲孔型操作中任一形式来形成。或者，开口18和内壁20可在具有限定开口18和内壁20的壁24的中空部分22周围形成。中空部分22的合适例子包括能够防止骨块通过其结构的任何生物相容性材料，如聚合材料、骨材料或任一生物相容性结构。中空部分22可在任意时间，如开口形成后置于植入物内，或当植入物形成时处于骨14和柔性平面部分16内。此外，融合植入物10、12可包括安全装置26，以确保一个或多个平面部分16维持在固定骨的位置。安全装置26可将平面部分16的一部分与平面部分的另一部分连接，和/或它可将一个平面部分固定于另一平面部分和/或环绕在骨的周围。安全装置26的合适例子包括热粘合、交联、胶粘合、化学键合、超声焊接、生物相容性缝合、金属丝、钉、绑带、钳和/或任何其它能够将柔性平面部分相对于它本身、另一柔性平面部分和/或相对于多个骨块固定在预定关系中的装置。安全装置26，以及柔性平面部分16也可含有在体内预定时间后会再吸收的材料。在另一可替代的实施方式中，可将骨生长促进材料28，如骨糊、松质骨、骨碎片、骨形态发生蛋白(BMP)、LIM矿化蛋白(LMP)、血小板衍生生长因子、骨髓穿刺液、干细胞、生物生长因子和/或其它合适材料及其组合插入开口18中，帮助融合相邻骨质和/或将在开口附近的多个骨块14互相固定，以帮助将骨保留在柔性平面部分16内。此外，可通过安全装置26连接多个植入物10、12，形成更大的植入物。
参见图3-5，融合植入物30、32、34的其它实施方式还包括含有多个骨块14和位于一层或多层36的一个或多个柔性平面部分16，以分别形成植入物30、32、34的结构部分。植入物30、32、34可包括任意方向，如基本水平、基本垂直、基本曲线、基本平面和/或其它合适的方向的层36。可将一些层36基本定为结构层，如包括皮质骨的层，而另一些层则定为融合层，如包括松质骨或其它骨生长促进物质的层，其它层可能是二者的组合。分层的植入物30、32、34在边缘38处可具有外露的骨14，或一层或多层36的其它部分。在边缘38处外露的骨14会通过层和/或通过植入物促进相邻骨结构的融合。或者，柔性平面部分16可覆盖在一个或多个边缘38处外露的骨14。而且，可通过，如滚压、叠积或对齐单层来形成多层而形成多层36。参见图6，例如，可通过将结构部分置于一个或多个柔性平面成分16上，然后将它们卷成径向分层的植入物而形成融合植入物。在该示例性实施方式中，将具有不同形式和组成的结构部分结合起来，它包含颗粒形态的松质骨块40，以及颗粒、块和束形态的皮质骨块42。此外，植入物中可包括骨生长促进材料28。在该示例性实施方式中，将松质材料置于卷的中心处，将皮质材料置于卷的周围，形成具有含融合促进核心的负荷承载螺旋结构的植入物。例如，可提供具有不同负荷承载容量和融合促进特性的骨块，以形成从致密的结构外缘到较不致密的融合促进核心的梯度。例如，可将植入物安排为，长皮质骨的完全矿化棒位于周边附近，较小和/或部分去矿化块靠近中心，松质和/或完全去矿化块位于中心。该植入物也可安排为从中心向外矿化程度逐渐升高。然而，应该注意，在分层或卷成的植入物的任意位置处都可包括任何形状的生物相容性材料，包括松质和/或皮质骨，和/或骨生长促进材料。
参见图7，融合植入物70的另一实施方式包括一个或多个柔性平面部分16的一层或多层51以及在平面部分分层中预定取向处的一个或多个结构部分52。预定取向可以与植入物的负荷承载轴线对准，以使结构部分52的定位可使植入物的负荷承载容量要比平面部分16的层51的负荷承载容量增大。例如，相对低负荷承载容量的柔性平面部分可将相对高负荷承载容量的结构部分固定于相邻骨结构之间的右上位置。在此结构中，固定部分可为缺少所需几何形状以维持其定位的结构部分提供稳定性和间隔填充特性。在图7的示例性实施方式中，柔性平面部分16包含一个相对薄的单层。在图8的示例性实施方式中，柔性平面部分包含通过将柔性平面部分16折叠回自身多次而形成的多层。植入物50和/或各层还可包括一个或多个开口18，它可能填充有骨生长促进材料28，以帮助相邻骨通过该植入物融合。此外，结构部分52可将多层柔性平面部分16互相固定，和/或可用安全装置26或其它相邻柔性平面部分16来确保这些层的相对位置和植入物的形状。任选地，可将附加材料，如骨块14置于柔性平面部分16的层之间，以增加负荷承载容量或增强通过植入物的融合。
参见图9，可将如上所述的骨/弹性部分融合植入物60的实施方式与固定装置62结合起来使用，形成骨固定系统64。在这种系统64中，将融合植入物60置于需要融合在一起的相邻骨结构66、68之间。固定装置62可包括一个或多个锚定装置72，如螺钉、销、金属线和/或其它用于将其与相邻骨结构66、68连接的装置，以限制它们之间的相对运动。固定装置62可基本上防止所有相对运动，或它可允许预定量的运动，以使植入物60在复原和融合过程期间保持与相邻骨结构66、68相接触。固定装置62的合适例子包括钢板、内部或外部杆系统、索系统、环扎系统、螺钉和其它合适装置及其组合。
含有皮质骨的结构部分可具有由供体骨纵轴径向测量的预定层厚度和几何形状，它们小于预定的最小壁厚度和几何形状。例如，预定的层厚度和几何形状在一个实施方式中可以在厚度小于2毫米的范围中，在另一实施方式中厚度小于1.8毫米，在又一实施方式中厚度小于1.5毫米，在又一实施方式中厚度小于1.0毫米，在再一实施方式中厚度小于0.5毫米。而且，例如，预定的最小壁厚度和几何形状可涉及与整体或组装的负荷承载植入物形成相关的最小可接受厚度或几何形状。预定的最小皮质几何形状可依应用而不同。例如，用于颈椎的最小几何形状可大大小于用于腰椎的最小皮质几何形状。例如，在一个实施方式中，如可从腓骨形成的、整体或组装的皮质楔形颈椎植入物的预定最小壁厚度或几何形状可以是3.0毫米，在另一实施方式中是2.5毫米，在又一实施方式中是2.0毫米，在再一实施方式中是1.8毫米。另一方面，在一个实施方式中，整体或组装的腰椎植入物的最小皮质几何形状可以是4.5毫米，在另一实施方式中是4.0毫米，在又一实施方式中是3.5毫米。
骨可获自任何合适的骨源，包括植入受体的自体植入物，相同物种另一来源的同种异体植入物，或者不同物种来源的异种植入物。肌肉骨骼组织的合适例子包括髂骨、肱骨、胫骨、股骨、腓骨、髌骨、尺骨、桡骨、肋骨、锥体和/或其它合适骨。可以机械加工、切割、削平，和/或从供体骨取出和/或形成这些骨块。
从多个骨块形成的植入物可具有耐压强度，或负荷承载容量，范围是50N至20,000N。例如，一些实施方式可具有大于70N、或大于800N、或大于1000N、或大于1200N、或大于3000N、或大于5000N、或大于7000N、或大于10,000N、或大于12,000N、或大于15,000N、或大于17,000N的耐压强度。此耐压强度所提供的负荷承载容量大于一般松质骨并高达一般皮质骨的负荷承载容量。
虽然详细描述和说明了植入物的实施方式和制造植入物的方法，但应理解，这些只是用以说明和示例，而不用以限制。因此，对植入物和方法的改变和修改对于本领域普通技术人员来说是显而易见的，而所附权利要求旨在覆盖所有这些修改和等价形式。

Claims (88)

1.一种用于融合相邻骨结构的植入物，它包含至少一个结构部分，该结构部分与至少一个柔性平面部分结合以将至少一个结构部分固定，从而形成该植入物。
2.如权利要求1所述的植入物，其特征在于，所述至少一个结构部分包含选自颗粒、条、块和束的至少一种形状。
3.如权利要求1所述的植入物，其特征在于，所述至少一个结构部分包含选自骨、金属、陶瓷、碳和聚合物的至少一种材料。
4.如权利要求1所述的植入物，其特征在于，所述至少一个结构部分包含选自聚乙稀、聚酯、聚乙醇酸、聚乳酸、聚四氟乙烯、聚芳基醚酮和聚醚醚酮的至少一种材料。
5.如权利要求1所述的植入物，其特征在于，所述至少一个柔性平面部分包含选自片材、块料、泡沫、织物、无纺织物、膜和网的至少一种形状。
6.如权利要求1所述的植入物，其特征在于，所述至少一个柔性平面部分包含选自身体组织、可吸收聚合物、不可吸收聚合物和金属的至少一种材料。
7.如权利要求1所述的植入物，其特征在于，所述至少一个柔性平面部分包含选自筋膜、皮肤、心包膜、部分去矿化的骨、完全去矿化的骨、软骨、腱和韧带的至少一种材料。
8.如权利要求1所述的植入物，其特征在于，所述柔性平面部分固定了多个结构部分，将它们维持成预定形状。
9.如权利要求1所述的植入物，其特征在于，所述结构部分具有纵轴，所述柔性平面部分将结构部分沿其纵轴固定在预定方向中。
10.如权利要求1所述的植入物，其特征在于，所述至少一个结构部分包含多个骨块。
11.如权利要求10所述的植入物，其特征在于，单个骨块比预定最小负荷承载容量低，而组合骨块形成预定容量大于预定最小负荷承载容量的植入物。
12.如权利要求11所述的植入物，其特征在于，单个骨块的预定几何形状与有关单个植入物的预定标准不同，而组合骨块形成获得预定几何形状的组合骨负荷承载植入物。
13.如权利要求12所述的植入物，其特征在于，单个骨块包含由具有纵轴的供体骨所获的皮质骨，由供体骨纵轴径向测量的、单个骨块的厚度小于2毫米厚。
14.如权利要求10所述的植入物，其特征在于，所述骨块包括选自颗粒、条、块和束的至少一种形状。
15.如权利要求10所述的植入物，其特征在于，所述骨块包含皮质骨，以在植入物中获得预定负荷承载容量。
16.如权利要求15所述的植入物，其特征在于，所述骨块还包含松质骨。
17.如权利要求16所述的植入物，其特征在于，所述单个骨块还通过选自化学和机械方法的至少一种方法互相连接。
18.如权利要求17所述的植入物，其特征在于，所述单个骨块通过选自销连接、缝合、压力、掺入粘合剂、胶原交联和连锁机械啮合的至少一种方法互相连接。
19.如权利要求18所述的植入物，其特征在于，将所述单个骨块与选自纤维蛋白胶、氰基丙烯酸酯、环氧树脂、聚异丁烯酸甲酯和明胶的至少一种材料互相连接。
20.如权利要求10所述的植入物，其特征在于，所述至少一个柔性平面部分包含选自片材、块料、泡沫、织物、无纺织物、膜和网的至少一种形状。
21.如权利要求10所述的植入物，其特征在于，所述至少一个柔性平面部分包含选自身体组织、可吸收聚合物、不可吸收聚合物和金属的至少一种材料。
22.如权利要求10所述的植入物，其特征在于，所述至少一个柔性平面部分包含选自筋膜、皮肤、心包膜、部分去矿化的骨、完全去矿化的骨、软骨、腱和韧带的至少一种材料。
23.如权利要求10所述的植入物，其特征在于，所述柔性平面部分还包含不同类型的伸长的平面材料。
24.如权利要求23所述的植入物，其特征在于，将一种类型的平面材料用于一个维度，而将不同类型的平面材料用于另一维度。
25.如权利要求10所述的植入物，其特征在于，所述平面部分16完全包含多个多个骨块以将它们固定为预定形状。
26.如权利要求25所述的植入物，其特征在于，所述预定形状包括选自基本直角的棱柱、球形和半球形及其组合的至少一种形状。
27.如权利要求10所述的植入物，其特征在于，所述柔性平面部分还包含至少一个开口，以允许相邻骨结构通过该植入物融合。
28.如权利要求27所述的植入物，其特征在于，将所述至少一个开口的尺寸做成比骨块小，以使所述柔性平面部分含有这些骨块。
29.如权利要求27所述的植入物，其特征在于，将固定材料插入至少一个开口以与所述骨块结合从而将它们固定在至少一个开口内。
30.如权利要求29所述的植入物，其特征在于，所述固定材料包含选自骨糊、胶原、明胶、聚合物、纤维蛋白和可凝固陶瓷的至少一种材料。
31.如权利要求27所述的植入物，其特征在于，所述柔性平面部分包含多个层，所述骨块位于这些层之间，且至少一个开口在这些层间具有预定间隔以可使骨块外露。
32.如权利要求27所述的植入物，其特征在于，所述至少一个开口含有延伸到整个植入物中的内壁。
33.如权利要求32所述的植入物，其特征在于，形成的所述内壁穿过所述柔性平面部分并穿过所述骨块。
34.如权利要求32所述的植入物，其特征在于，通过选自钻、切和冲孔的至少一种操作形成所述开口和内壁。
35.如权利要求32所述的植入物，其特征在于，所述开口和内壁包含具有限定所述开口和内壁的壁的中空部分。
36.如权利要求35所述的植入物，其特征在于，所述中空部分包含能够防止骨块通过其结构的至少一种生物相容性材料。
37.如权利要求27所述的植入物，其特征在于，所述植入物还包含插入至少一个开口的骨生长促进材料。
38.如权利要求37所述的植入物，其特征在于，所述骨生长促进材料包含选自骨糊、松质骨、骨碎片、骨形态发生蛋白(BMP)、LIM矿化蛋白(LMP)、血小板衍生生长因子、骨髓穿刺液、干细胞、生物生长因子及其组合的至少一种材料。
39.如权利要求10所述的植入物，其特征在于，所述植入物还包含安全装置，以确保所述平面部分维持在固定骨的位置。
40.如权利要求39所述的植入物，其特征在于，所述安全装置将平面部分的一部分与平面部分的另一部分连接。
41.如权利要求39所述的植入物，其特征在于，所述安全装置包含选自缝线、金属丝、销、绑带、钳、钉、热粘合、交联、超声焊接和粘合剂的至少一种装置。
42.如权利要求39所述的植入物，其特征在于，所述安全装置连接多个植入物，形成更大的植入物。
43.如权利要求39所述的植入物，其特征在于，所述安全装置包含在体内预定时间后会再吸收的材料。
44.如权利要求10所述的植入物，其特征在于，所述骨块和柔性平面部分形成多个层。
45.如权利要求44所述的植入物，其特征在于，用所述柔性平面部分环绕骨块形成该植入物。
46.如权利要求45所述的植入物，其特征在于，所述植入物包含卷在至少一个柔性平面部分中的松质骨块和皮质骨块。
47.如权利要求46所述的植入物，其特征在于，所述松质骨块位于该卷中心附近，所述皮质骨块位于卷的周围附近。
48.如权利要求44所述的植入物，其特征在于，所述层的取向定为选自基本水平、基本垂直、基本曲线和基本平面的方向。
49.如权利要求44所述的植入物，其特征在于，至少一层主要提供结构支持，且至少一层主要提供骨融合材料。
50.如权利要求49所述的植入物，其特征在于，所述至少一层结构支持层包含皮质骨，所述至少一层融合层包含松质骨。
51.如权利要求44所述的植入物，其特征在于，所述层相对于植入物中心径向形成，所述骨块包含具有不同负荷承载容量的多个骨块，将所述骨块排列在该径向诸层中，其中具有较低负荷承载容量的骨块靠近中心而具有较高负荷承载容量的骨块远离中心。
52.如权利要求44所述的植入物，其特征在于，至少一层在边缘处包含外露的骨，以促进相邻骨结构通过该层融合。
53.如权利要求9所述的植入物，其特征在于，所述至少一个柔性平面部分包含多层，所述至少一个结构部分位于穿过这些层的至少一个开口中。
54.如权利要求53所述的植入物，其特征在于，所述至少一个结构部分基本垂直于所述至少一个平面部分。
55.如权利要求9所述的植入物，其特征在于，所述植入物还包含穿过该植入物的开口，以促进与该植入物相邻的骨通过该开口融合。
56.如权利要求55所述的植入物，其特征在于，在所述至少一个开口中还包含骨生长促进材料。
57.如权利要求53所述的植入物，其特征在于，所述至少一个结构部分将多层柔性平面部分互相固定。
58.如权利要求53所述的植入物，其特征在于，至少一层骨块位于柔性平面部分的这些层之间。
59.如权利要求9所述的植入物，其特征在于，所述至少一个结构部分包含能够耐受预定负荷的生物相容性材料。
60.如权利要求59所述的植入物，其特征在于，所述至少一个结构部分包含选自骨部分、聚合物部分、可吸收聚合物部分及其组合的至少一个结构。
61.如权利要求59所述的植入物，其特征在于，所述至少一个结构部分包含选自聚乙稀、聚酯、聚四氟乙烯、聚芳基醚酮、聚醚醚酮、聚乳酸、聚乙醇酸、碳及其组合的至少一种材料。
62.如权利要求1所述的植入物，其特征在于，所述植入物还包含与所述相邻骨结构连接的固定装置，以限制它们之间的相对运动。
63.如权利要求62所述的植入物，其特征在于，所述固定装置基本上防止了相邻骨结构之间的所有相对运动。
64.如权利要求62所述的植入物，其特征在于，所述固定装置允许相邻骨结构之间在融合过程中发生预定量的相对运动。
65.如权利要求62所述的植入物，其特征在于，所述固定装置选自钢板、内部或外部杆系统、索系统、环扎系统、螺钉及其组合。
66.一种用于融合相邻骨结构的负荷承载植入物，它包含：
多个骨块；和
一个柔性平面部分，该部分含有骨块以使植入物形成预定形状。
67.如权利要求66所述的植入物，其特征在于，所述柔性平面部分形成矩形容器。
68.如权利要求66所述的植入物，其特征在于，所述柔性平面部分形成基本类似于人椎间盘形状的扁球形容器。
69.一种用于融合相邻骨结构的负荷承载植入物，它包含：
多个骨块；和
一个柔性平面部分，该骨块和柔性平面部分形成交替层。
70.如权利要求69所述的植入物，其特征在于，所述骨块在所述柔性平面部分上方分层，然后将植入物卷起形成分层的螺旋结构。
71.如权利要求70所述的植入物，其特征在于，所述分层的螺旋结构在螺旋中心包含松质骨块，从中心径向向外是皮质骨块。
72.如权利要求70所述的植入物，其特征在于，所述植入物还包含至少一个径向形成的穿过螺旋结构的开口，以使骨块外露而促进融合。
73.如权利要求69所述的植入物，其特征在于，所述植入物还包含多个柔性平面部分，所述多个骨块和多个柔性平面部分交替地互相叠积，一个所述柔性平面部分包围住叠积结构，在植入物中含有多个骨块。
74.如权利要求69所述的植入物，其特征在于，所述植入物还包含与所述相邻骨结构连接的固定装置，以限制它们之间的相对运动。
75.一种用于融合相邻骨结构的负荷承载植入物，它包含：
含有柔性平面部分的多层；和
至少一个结构部分，该部分延伸到该多层的至少两层中以将该至少一个结构部分以预定方向附着在层中。
76.如权利要求75所述的植入物，其特征在于，所述多层包含折叠回自身的一个柔性平面部分。
77.如权利要求75所述的植入物，其特征在于，所述至少一个结构部分的取向定为基本垂直于所述多层。
78.如权利要求77所述的植入物，其特征在于，所述植入物还包含基本垂直于多层取向的多个结构部分。
79.如权利要求75所述的植入物，其特征在于，所述至少一个结构部分的取向定为与所述多层成不是90度的角度。
80.如权利要求75所述的植入物，其特征在于，所述植入物还包含延伸到多层中的至少一个开口，以促进相邻骨结构通过该开口融合。
81.如权利要求80所述的植入物，其特征在于，在所述至少一个开口中还包含骨生长促进物质。
82.如权利要求75所述的植入物，其特征在于，所述植入物还包含与所述相邻骨结构连接的固定装置，以限制它们之间的相对运动。
83.一种用于融合相邻骨结构的负荷承载植入物，它包含：
将所述相邻骨结构支持在间隔关系中的负荷承载装置；和
将负荷承载装置固定在预定方向上的固定机构。
84.一种治疗身体以促进相邻骨结构融合的方法，该方法包括下述步骤：
提供多个骨块；
将多个骨块包含在柔性平面部分中以形成具有预定形状的植入物；和
将植入物置于相邻骨结构之间。
85.如权利要求84所述的方法，其特征在于，所述骨块和柔性平面部分形成交替层。
86.如权利要求84所述的方法，还包括提供延伸到所述柔性平面部分中的负荷承载部分，从而使柔性平面部分将负荷承载部分相对于相邻骨结构固定在所需方向上的步骤。
87.一种用于融合相邻骨结构的系统，它包含：
多个骨块；
至少一个基本上固定了多个骨块的柔性平面部分；和
可与相邻骨结构连接并具有限制相邻骨结构之间相对运动的结构的固定装置。
88.一种用于融合相邻骨结构的植入物，它包含：
至少一个具有第一负荷承载容量的固定部分；和
至少一个具有比第一负荷承载容量大的第二负荷承载容量的结构部分，所述固定部分将所述结构部分相对于相邻骨结构固定在预定方向上。
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