CN1893897A - 柔性脊椎盘 - Google Patents

柔性脊椎盘 Download PDF

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CN1893897A
CN1893897A CNA2004800327893A CN200480032789A CN1893897A CN 1893897 A CN1893897 A CN 1893897A CN A2004800327893 A CNA2004800327893 A CN A2004800327893A CN 200480032789 A CN200480032789 A CN 200480032789A CN 1893897 A CN1893897 A CN 1893897A
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spinal disc
prosthesis according
prosthesis
main body
implantable spinal
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D·库
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Spinemedica Corp
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Spinemedica Corp
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Abstract

本发明提供了一种医疗器件(10)及其应用。这种器件可用于病态或受损椎间盘的替换或治疗。这种器件的体积可占据椎体(16、17)之间间隙，其机械弹性使椎体之间能够产生相对运动，并具有足够的强度来承受椎骨上的力和载荷。可以对这种器件进行改进使得其能够固定到脊椎骨上。还可以对这种器件进行改进以便于置入椎体之间的解剖学间隙中。这种器件可以设置成能够膨胀，以恢复椎骨间隙的正常高度。

Description

柔性脊椎盘
技术领域
本发明涉及一种修复用脊椎盘。具体地，本发明涉及一种用坚固弹性体制成的可植入的人造脊椎盘，能够起到正常脊椎盘的作用。
背景技术
脊柱由称作椎体的骨结构组成，椎体被称作椎间盘的软组织结构隔开。椎间盘通常称作脊椎盘。脊椎盘主要起到脊椎骨之间的机械缓冲垫的作用，使得轴向骨骼的椎骨段之间能够进行受控运动。脊椎盘起到接头的作用，允许生理程度的弯曲、伸展、侧向弯曲和绕轴转动。脊椎盘的机械性能必须能够进行这些动作，并具有足够的弹性强度以抵抗脊椎骨造成的外力和扭矩。
正常的脊椎盘是一种混合脉管结构，包括两个椎骨端板(端板)、环纤维(环)和髓核(核)。端板包括覆盖硬坚质骨薄层的薄软骨，坚质骨附着在椎体的海绵状松质骨上。端板用于将相邻的椎骨连接到脊椎盘。
脊椎盘的纤维环是一种坚韧的外纤维环，高度大约为10至15毫米，厚度大约为15至20毫米。纤维的结构类似于汽车轮胎，具有15至20个重叠的层，并沿两个方向以大致30-40度角插入上下椎体。这种构造特别能够抵抗扭矩，因为当椎骨相互间沿任一方向转动时，大约有一半的成角度的纤维将绷紧。叠层相互之间的附着力稍弱一些。相连的纤维还能够防止当脊柱产生复杂的扭转运动时脊椎盘横向挤出。
纤维环里面是高含水量的胶状髓核。髓核起到平衡纤维环内压力的液体的作用。这种材料的稠度和形状与果冻炸面圈的内部类似。髓核类似于流体的松软性质使它受挤压力时能够收缩而在渗透压的作用下会膨胀。髓核的离子浓度能够产生大约0.1至0.3兆帕的渗透膨胀压。因此，胶状髓核能够象液压起重机那样支承外加载荷。纤维环和髓核一起支承当弯曲、提升时因相邻椎体产生的力而挠曲的脊柱。
脊椎盘上的压缩载荷随姿势而变化。当人体仰卧时，第三节腰椎盘的压缩载荷为300牛顿(N)，而当采取直立姿势时，压缩载荷上升到700牛顿。当身体向前弯曲仅仅20度时，压缩载荷又升高到1200牛顿。
脊椎盘会由于外伤或疾病而产生位移或受到损害。当环纤维变弱或撕裂时，髓核的内部材料会从其正常的内环范围永久鼓出、膨出或挤出，于是发生脊椎盘突出。突出或“滑移”的髓核组织可挤压脊神经，结果造成腿疼、肌力和控制受损、甚至瘫痪。或者，随着脊椎盘的退化，髓核丢失其水结合能力而缩小，结果使脊椎盘的高度减小。于是，髓核体积减小，导致叠层松散结合部位的纤维环起皱。当纤维环的这些重叠层起皱和分开时，可能产生环向或径向的纤维环撕裂，结果可能造成持久的伤残背痛。相邻的辅助脊椎面关节也将被迫处于重叠位置而引起额外背痛。产生脊椎盘突出的最常见部位是在下腰部。颈部脊椎盘也常常受到影响。
对于脊椎盘突出或退化目前基本上有三种治疗方法：保守护理、椎间盘切除术和融合术。大部分下背痛患者通过卧床休息的保守疗法能够康复。
椎间盘切除术能够提供优良的短期效果。然而，从长期的生物力学观点来看，椎间盘切除术不是最理想的。当脊椎盘突出通过外科手术除去时，脊椎盘间隙将变窄而可能失去其正常的稳定性。脊椎盘高度损失可能导致脊椎面关节随着时间推移而产生骨关节炎变化。关节失去正常的灵活性，使相邻的脊椎盘产生较高的应力。有时，在损伤的脊椎盘破坏后必须恢复正常的脊椎盘高度。
融合术是一种通过刚性金属块，通常使用螺丝和板，将两个椎体相互固定在一起的治疗方法。现有的治疗方法是通过置入可结合两个椎体的金属器件和骨碎片来保持脊椎盘间隙。这种器件类似于带螺丝的修补板，可将其中一个椎体固定到另一个椎体上。或者，可以将充有骨碎片的空心金属圆筒设置在椎骨间隙中，将椎体接合在一起(比如用Sofamor-Danek生产的LT-CageTM或DePuy生产的Lumbar I/F CAGETM)。这些器件对于患者来说存在很多缺点，因为骨头被结合成刚体，不具有天然脊椎盘的柔韧性或吸收冲击性能。
融合术一般来说在消除疼痛症状和使关节稳定方面具有较好效果。然而，由于结合段是固定，其活动范围和作用在邻接脊椎盘上的力增大，有可能加快退化过程。过去，融合术也用于膝关节；然而，随着活动全膝关节修复假体的出现，这种治疗方法并不受欢迎。
近来有些器件试图通过金属和硬塑料器件使椎体之间能够产生运动，这些器件允许部件之间有一定程度的相对滑移(比如ProDisk、Charite，可参见美国专利5,314,477、4,759,766、5,401,269和5,556,431)。这些器件的刚性件允许产生一些相对运动但没有吸震作用。
最近，还提出过若干种修复用脊椎盘髓核器件。这些器件装配在突出髓核的间隙中，需要有约束封套或完整的环圈使液体状的髓核修复假体保持在空腔内。这些器件可能穿过损坏的纤维环挤出、漏出或突出，结果造成相当大的疼痛。
椎间盘退化造成痛苦和残废是一个相当严重的经济和社会问题。任何能够改进这些状况而不会对脊椎盘造成更多破坏或融合的有效手段在医冶患者方面都将起到重要的作用。因此确实需要有一种能够使脊椎盘恢复其尺寸、荷载承受能力以及灵活性的可植入修复用脊椎盘。此外，还需要有一种在置入之后能够以缓慢方式恢复脊椎盘高度的简单修复假体。理想的是，脊椎盘高度应当在大于3小时但小于3个月的时间内恢复。
在授予Patil的先有技术美国专利No.4,309,777公开的人造脊椎盘是一种使用金属弹簧和杯件的修复用假体。Kenna的美国专利No.4,714,469介绍了一种由刚性固体构成的脊椎植入物，其表面一部分包括多孔涂层。Kuntz的美国专利No.4.349,921涉及包括一对硬塞的椎间盘修复假体，用来替换退化的脊椎盘。授予Stubstad等人的美国专利No.3,867,728涉及用于替换整个脊椎盘的器件，通过将竖直、水平或轴向的弹性聚合物片层压起来制成。授予Lee等人的美国专利No.4,911,718涉及一种由三个不同部分即核、环及端板组成的脊椎盘弹性间隔体，分别用不同的材料制成。Lee所介绍的椎间盘具有特殊的层状结构，具有3-24个分开的单向强化纤维薄层，这些组件沿特定的方向布置。授予Froning的美国专利No.3,875,595涉及一种可胀缩的塑料胆状髓核假体。Ray等人的美国专利No.4,772,287和4,904,260介绍了带或不带治疗剂的圆柱形修复用脊椎盘囊。授予Ray等人的美国专利No.5,674,295和5,824,093介绍了枕状或囊状的带有水凝胶芯和约束封套的修复用髓核假体。Bao等人在美国专利No.5,047,055和5,192,326公开了用水凝胶制成的人造髓核，其分别具有形状符合椎间盘腔的大块形式或装在多孔封套内的珠粒形式。Bao等人在美国专利No.5,534,028介绍了髓核替换物的另一种变型，其前后部的弹性模量不同。
椎间盘在解剖学上和功能上是一种复杂的关节，由三个部分组成，每部分都具有其自身独特的结构特性。要用可接受的材料来设计和制造这种能够模仿天然脊椎盘功能的复杂假体十分困难。在此公开的新的设计方案为这一难题提供了解决方法。
金属或刚性脊椎盘替换物的缺点是不能在多个平面中提供任何减震弹性或柔性。Kuntz的器件使用刚性塞来替换脊椎盘间隙。前面Stubstad等人和Lee的设计方案中所要求的多个部件难以制造和安装。Lee的器件作为整个脊椎盘的替换物太过脆弱、制造复杂，而且不能随着时间的推移使脊椎盘恢复高度。
Froning以及Ray等人分别使用了装满流体或触变凝胶的球囊，但并没有解决这些问题。器件中含有必须完全密封以防止渗漏的流体。这些器件中的流体在脊柱进行正常的弯曲和扭转活动时可能漏出或挤出。Ray的器件还需要无弹性的护罩。Bao等人专利中所采用的水凝胶腰部椎间盘髓核假体要比整个椎间盘弱很多。这种髓核的作用是通过将竖向荷载分布到受损或修理过的天然纤维环上来防止髓核假体鼓出和突出。
还有一个问题是先有技术的弹性器件有可能从椎骨间隙移位或挤出。
发明内容
本发明的目的是提供一种新颖的脊椎盘替换物，具有柔性，但却十分坚固，能够起到机械减震的作用并允许椎骨之间运动具有灵活性。这种器件可作为医用脊椎盘永久植入。本发明的器件具有的压缩弹性模量类似于正常的脊椎盘，在0.1兆帕斯卡(兆帕)至10兆帕的范围内。这与以前使用的压缩模量通常大于100兆帕的高分子聚乙烯塑料相比更加柔软。本发明的弹性模量能够具有减震作用和所要求的灵活性。
本发明的还有一个新颖之处在于。是用不会渗漏的固体材料制成的。而Bao和Ray的专利所介绍的液体组件或软凝胶组件可能会漏出和挤出。
一般而言，可以使用任何具有生物医学用途的弹性体，只要这种弹性体在承受人体脊椎骨的载荷时具有的抗压强度至少为1兆帕，最好为10兆帕。这种弹性体的极限延伸率最好应当为15％或更大，极限抗拉或抗压强度应当最好为100千帕或更大。从生物适应性和可控膨胀性来说，亲水聚合物是优选的。
本发明还包括对固定或附着力进行改进，进一步防止器件挤出。这种固定可以通过对器件顶面和底面进行改性，允许纤维附着和增大摩擦来实现，或者这种器件可以具有从器件表面或周缘的材料延伸部分，可通过外科手术固定到椎体上。
而且这种修复用假体还可以随着时间的推移而膨胀或扩大使脊椎盘以受控方式恢复高度，因而允许在原处进行固定。虽然Ray的器件在置入时也能够胀大，但没有任何一种先有技术介绍过能够被动改变其外形尺寸大小的具有可控膨胀特性的器件。
这种器件通过机械方式起到正常脊椎盘的作用，能够连接到椎体的端板，并能够膨胀以恢复椎骨间隙的正常高度。可以通过外科手术方法将这种修复用脊椎盘插入椎骨间隙。它可以隔开脊柱或身体其它部分中的两个骨表面。这种修复假体可以用于人类或作为兽医学器件。
这种器件的形状是一种复杂的三维结构，能够提供解剖学形状和机械支承。这种解剖学形状具有不规则的体积以填充椎间盘间隙。身体座标可以使用解剖学方向的上(朝头部)、下(朝足部)、外侧(朝侧面)、内侧(朝中线)、后(朝背面)、前(朝前面)来描述。从顶视图看，本发明的器件是肾形的，肾门朝后面。器件的径向范围基本包括在脊柱尺寸内。
附图说明
图1是根据本发明的修复用脊椎盘的透视图；
图2是修复用脊椎盘的前侧视图；
图3是修复用脊椎盘的顶视或俯视图；
图4是优选的修复用脊椎盘的透视图，带有可固定到椎体的延伸部分；
图5是一优选的修复用脊椎盘的透视图，其顶面带有纤维或进行过表面处理；
图6是优选的修复用脊椎盘的透视图；
图7是包括变性脊椎盘区域的脊椎节段的顶视图；
图8是植入了修复用脊椎盘的人类脊椎盘间隙的侧视图。
具体实施方式
如图1中所示，脊椎盘主体10具有周缘表面11、基本上是凹进的上表面12、和基本上是凸起的下表面13。脊椎盘主体10的周缘表面11对应于天然脊椎盘的纤维环(环)。脊椎盘主体10的上表面12和下表面13对应于天然脊椎盘中的椎骨端板(端板)。脊椎盘主体10的内部对应于天然脊椎盘的髓核(核)。图2示出了当从前面看时大体上是矩形的脊椎盘主体10。如参考图8更清楚的显示，上表面12的周缘14与下表面13的周缘15基本上是平直的，以便为上下椎体16和17提供良好的接触界面。
上表面12和下表面13最好是粗糙的带有表面纹理，其沿高度的粗糙度指数在大约1纳米与大约2毫米之间。周缘表面11一般比粗糙的上下表面12和13更加光滑。
如图3所示，当从上面看时，脊椎盘主体10大致上是肾形的，具有延伸的卵形表面18和凹进部分19。
图4示出了被固定延伸件22至少部分包围的脊椎盘主体，其中固定延伸件22用于固定到相邻的椎体。固定延伸件22包括箍带部分23、若干个下突片24和若干个上突片25。箍带部分23可固定于周缘表面11的卵形延伸表面18。固定延伸件22的下突片24可固定到下椎体17。固定延伸件22的上突片25可固定到上椎体16。
图5示出了优选实施例的脊椎盘主体10，其中上表面12和下表面13分别被纤维或表面纹理如凹槽26覆盖，使得组织能够从相邻的上椎体16和下椎体17向内生长。在优选实施例中，纤维或表面纹理是沿交叉影线的方向施加的。
图6示出了还有一个优选实施例的脊椎盘主体10，其中上表面12和下表面13分别设有小孔或凹割27，使得组织能够从相邻的上椎体16和下椎体17向内生长。在一优选实施例中，小孔或凹割27的直径是变化的。
图7示出了变性脊椎盘区域以及与脊神经29接触的突出脊椎盘28。马尾部用30表示。硬脊膜囊用31表示。神经节用32表示。本发明涉及用脊椎盘主体10替换突出脊椎盘28，如图8中所示。
举例来说，图8示出了植入上椎体16(L4)与下椎体17(L5)之间的脊椎盘主体10。在径向面中，脊椎盘10的前部20的高度最好大于脊椎盘10的后部21的高度。33表示髂骨的关节面，而34表示脊椎面关节。
实例1
可用于本发明实施例的弹性体包括硅橡胶、聚亚安酯、聚乙烯醇水凝胶、聚乙烯基吡咯烷酮、聚羟乙基异丁烯酸、HYPANTM和SalubriaTM生物材料。用于制备这些聚合物和共聚物的方法在本技术领域中是众所周知的。在此实例中介绍的器件用专利No.5,981,826和6,231,605所公开的弹性水凝胶材料制成，其机械压缩弹性模量大约为1.0兆帕、极限延伸率大于15％、强度极限大约为5兆帕，文中引用参考这些专利的内容。这种器件能够承受超过1200牛顿的力。
在本发明实施例中使用的一种优选的水凝胶是高水解结晶聚乙烯醇(PVA)。聚乙烯醇水凝胶可以通过本技术领域中已知的任何方法用市场上能够买到的聚乙烯醇粉末制备。最好是通过美国专利No.5,981,826和6,231,605所公开的方法制备，文中引用参考其内容。通常，将25至50％(按重量计算)的聚乙烯醇粉末与稀释剂如水混合。然后在大约100摄氏度(C)的温度下加热混合物，直至形成粘稠溶液。接着将溶液倒入或注入如图1所示形状的金属或塑料模具中。使器件冷却到-10摄氏度以下，优选的是冷却到大约-20摄氏度。使器件冻结和解冻若干次直至形成具有所要求机械性能的固体器件。然后可以使器件部分或完全脱水，用于植入。最后得到的修复假体的机械弹性模量为2兆帕，抗拉和抗压极限强度至少为1兆帕，优选是大约为10兆帕。通过这种方法制造的修复假体可允许顶面和底面之间在扭矩超过1牛顿米的情况下转动10度而不会破坏。这样制造的器件当处于与天然椎间盘相同的载荷条件时不会破裂。这种器件是用一种固态弹性体材料制成，通过了国际标准化组织规定的细胞毒性和过敏性试验(ISO 10993-51999：医疗器械生物学评价-部分5：体外(斜体字)细胞毒素学检测和ISO 10993-102002：医疗器械生物学评价-部分10：刺激和滞后过敏试验)，证明是生物相容的。
实例2
修复用脊椎盘可以用各种弹性体来制造，只要其形状、弹性、生物适应性以及强度要求能够满足。这些可植入的医药器材可以是，比如聚亚安酯、硅树脂、水凝胶、胶原蛋白、透明质酸酶、蛋白质以及其它可用来实现所要求弹性机械性能范围的人造聚合物。聚合物如硅树脂和聚亚安酯的机械弹性模量值一般小于100兆帕。水凝胶和胶原质也可以用来制造机械弹性模量值小于20兆帕但大于1.0兆帕的器件。硅树脂、聚亚安酯和某些水凝胶的极限抗拉强度通常大于100或200千帕。这类材料一般可承受超过0.01牛顿米的扭矩不会破坏。
修复假体的主体还可以用聚乙烯、聚乙醇酸、聚对苯二甲酰对苯二胺纤维或丝加强，这些纤维沿圆周方向布置，最好在器件主体内形成完整的编织网环，或形成类似天然脊椎盘纤维环的交叉结构。
对于不同的患者，修复用脊椎盘的确切尺寸可以变化。成年人脊椎盘的典型尺寸是短轴为3厘米、长轴为5厘米、厚度为1.5厘米，但在不脱离本发明精神的情况下这些尺寸可以改变500％。
实例3
在模制过程的各阶段可以用不同重量百分比的聚乙烯醇(PVA)制造器件，使修复用脊椎盘内产生各种不同的机械弹性模量，因此器件的弹性模量不是恒定的。类似地，可以将两种弹性体混合起来产生变化的弹性模量。另一种方法是将纤维或丝网结合到器件内，产生各向异性的弹性模量。
实例4
一种腰子形的器件所用的材料，当置入身体之后会扩大到固定尺寸。这种修复假体用Peppas所介绍的聚乙烯醇水凝胶制成，聚乙烯醇水凝胶可通过冻结-熔化循环过程制备。可参考《聚合物》，33卷，3932-3936页，(1992年)；作者Shauna R.Stauffer和Nikolaos A.Peppas。这种修复假体表现出膨胀特性，当放入生理盐水槽中24小时后可比其原始尺寸增大5％至六倍(600％)。沿器件头-尾方向测得的膨胀压力大于1牛顿。许多种会因水合作用或渗透压力而膨胀的材料都能够产生膨胀和扩大。这种膨胀和扩大可用来增强材料中的水分输送。器件的扩大也可以通过嵌入器件的机械弹簧来实现。或者，通过内部弹簧可以扩大器件的高度，这种内部弹簧用一个或多个能够施加大于1牛顿膨胀力的金属片或塑料片制成。可以预料沿高度方向膨胀超过10％对于这种器件会是有用的，因而包括在本发明中。
实例5
对椎体的额外粘附力可以通过在修复假体的顶面和底面上进行表面改性获得。表面改性可以包括表面的物理刻痕或印痕、加在表面上的化学刺激物、对表面进行改性的生物化学试剂、或者从表面延伸以增强对椎体或椎骨端板粘附力的细小纤维。这些纤维和表面改性可诱导人体产生纤维化或成骨反应，增强对椎体的附着力。
纤维化可以由许多种方法引起，包括形成开口小孔或粗糙表面、带有凹割的多孔结构、加入骨引导或诱发剂、加入其它聚合物如聚酯织物或纤维、加入其它生物活性分子如肿瘤坏死因子或胶原质、加入金属固形物或网状物、形成深度超过5纳米(nm)的粗糙表面。粗糙表面中可以包括带有凹割的直径为2毫米(mm)的小孔，其类似于海绵。表面还可以进行生化改性以增强水分输送或进行物理改性以增强化学输运。可以预料有许多方法能够改变修复假体的表面特征，实现促进细胞向内生长或连接胶原质或骨头的同一目的。本发明已经预先考虑到这些因素以及同类的其它因素。
实例6
这种器件可以具有附加部分，使得能够在原处直接进行固定。举例来说，可以使修复假体具有能够固定到椎体中的螺旋锚固点，如图4中所示。这样一种器件的突片延伸部分可以用弹性模量在0.2至5兆帕之间的水凝胶制成。固定附加部分可以从替换脊椎盘的主体延伸。还可以沿脊椎盘的周缘用包括连续纤维环的材料包围弹性体，连续纤维环与固定附加部分22相连。
通过膨胀体与椎骨之间的织物或插入物可实现机械连接。连接件可以是能进行生物降解的或者可以是永久性的。可以使用聚酯纤维、螺丝、胶水、固定板以及其它类似的连接件，但并不限于这些。
实例7
在一优选实施例中，肾形的无菌修复假体用作脊椎盘修复假体。这种修复假体的主体是用水凝胶材料制成，其机械压缩模量在1.5兆帕和10兆帕之间，沿某个方向的极限延伸率大于50％。这种材料的膨胀特性是当放入生理盐溶液时高度可扩大50％。修复假体中与椎骨接触的顶面和底面具有暴露的聚酯纤维，可嵌入主体中并能够刺激长期连接的纤维化反应。此外，还可以在顶面和底面形成深度为2毫米的开口小孔以促进骨连接，如图6所示。这些孔具有凹割，使得器件与椎体端板的纤维组织之间能够形成牢固的连接。可以在靠近周缘表面和上下表面处将聚对苯二甲酰对苯二胺织物薄片模制到器件并延伸到器件主体以外大约1厘米。这种织物附加部分被用来将器件连接到椎骨的侧面。
虽然已经介绍了本发明的一些实例，但在不脱离本发明精神和范围的情况下显然可以对其作出许多修改和变化。

Claims (45)

1.一种可植入修复假体，形状大致类似于椎间盘，包括生物相容弹性体，其机械弹性模量小于大约100兆帕、极限抗拉强度一般超过大约100千帕，所述修复假体具有柔性，在扭矩超过0.01牛顿米的情况下，允许其顶面和底面之间转动2度而不会破坏。
2.根据权利要求1所述的修复假体，其特征在于，所述器件的极限强度可承受超过1兆帕的压缩载荷。
3.根据权利要求1所述的修复假体，其特征在于，所述器件的材料的机械极限强度超过5兆帕。
4.根据权利要求1所述的修复假体，其特征在于，所述器件用一种固态弹性体材料制成。
5.根据权利要求1所述的修复假体，其特征在于，所述弹性体的机械弹性模量大于1.0兆帕。
6.根据权利要求1所述的修复假体，其特征在于，所述弹性体的机械弹性模量小于20兆帕。
7.根据权利要求1所述的修复假体，其特征在于，所述器件的机械弹性模量小于10兆帕但大于200千帕。
8.根据权利要求1所述的修复假体，其特征在于，所述弹性体的机械弹性模量不是恒定的。
9.根据权利要求1所述的修复假体，其特征在于，当浸入生理盐水一天之后，所述修复假体的交货尺寸至少沿某一方向可扩大最少5％。
10.根据权利要求1所述的修复假体，其特征在于，所述修复假体的交货尺寸在体内至少沿某一方向可扩大最少50％而不用注射其它材料。
11.根据权利要求1所述的修复假体，其特征在于，当植入体内一天之后，所述修复假体的交货尺寸至少沿某一方向可扩大最少20％并且能够沿头尾方向产生超过1牛顿的力。
12.根据权利要求1所述的修复假体，其特征在于，通过将弹簧和弹性体部件结合起来能够使所述修复假体的交货尺寸至少扩大100％。
13.根据权利要求1所述的修复假体，其特征在于，所述假体经过改性以提供特定的表面特征。
14.根据权利要求13所述的修复假体，其特征在于，所述表面特征通过物理或生物化学方法进行改性，以提供对椎体增强的粘附力。
15.根据权利要求13所述的修复假体，其特征在于，所述表面部分包括织物。
16.根据权利要求13所述的修复假体，其特征在于，所述表面部分包括金属固形物或网状物。
17.根据权利要求13所述的修复假体，其特征在于，所述表面部分包括带有凹割的多孔结构。
18.根据权利要求13所述的修复假体，其特征在于，所述表面部分包括深度超过5纳米的粗糙表面。
19.根据权利要求13所述的修复假体，其特征在于，所述表面部分包括生物活性分子。
20.根据权利要求1所述的修复假体，其特征在于，所述修复假体的表面特征经过改性以促进细胞向内生长。
21.根据权利要求1所述的修复假体，其特征在于，所述表面特征进行生化改性以增强水分输送。
22.根据权利要求1所述的修复假体，其特征在于，所述表面特征被物理改性以增强化学输运。
23.根据权利要求1所述的修复假体，其特征在于，所述器件用一种弹性模量在0.2至5兆帕之间的弹性体制成，并具有固定到相邻椎体的突片延伸部分。
24.根据权利要求1所述的修复假体，其特征在于，所述椎间盘由包括连续纤维环的材料构成。
25.根据权利要求1所述的修复假体，其特征在于，还包括附加部分，允许通过物理方法固定到椎体并防止部件在现场产生移位。
26.根据权利要求1所述的修复假体，其特征在于，所述材料是一种水凝胶。
27.根据权利要求1所述的修复假体，其特征在于，所述材料是由一种以上的物质组成的复合材料。
28.根据权利要求1所述的修复假体是一种可永久植入的医疗器件。
29.根据权利要求1所述的无菌修复假体，其特征在于，所述主体被制成卵形或肾形，可用作脊椎盘修复假体，被放入生理盐溶液中时沿高度方向扩大20％，在所述主体的上下表面具有外露的纤维，所述主体由生物相容的弹性体构成，其压缩模量在1.5兆帕和10兆帕之间，极限抗压强度超过1兆帕，沿某个方向的极限延伸率大于25％，并包括从主体延伸的织物，以固定到所述椎骨的侧面。
30.根据权利要求1所述的修复假体用作脊椎盘的医用植入物。
31.通过外科手术将根据权利要求1的修复假体插入所述椎骨间隙。
32.根据权利要求1所述的修复假体用来隔开两个骨表面。
33.根据权利要求1所述的修复假体用于兽医学应用。
34.一种可植入的脊椎盘主体，具有通过周缘表面连接的上表面和下表面，所述可植入脊椎盘主体包括生物相容弹性体，其机械弹性模量小于大约100兆帕，极限抗拉强度超过大约100千帕。
35.根据权利要求34所述的可植入脊椎盘主体，其特征在于，所述可植入脊椎盘的上下表面是肾形的，具有延伸的卵形表面和凹进表面，且所述可植入脊椎盘的横截面大体上是矩形的。
36.根据权利要求34所述的可植入脊椎盘主体，其特征在于，所述上下表面的周缘基本上是平直的。
37.根据权利要求34所述的可植入脊椎盘主体，其特征在于，所述上下表面沿高度的粗糙度指数在大约1纳米与大约2毫米之间。
38.根据权利要求37所述的可植入脊椎盘主体，其特征在于，所述周缘表面的粗糙度指数小于1毫米。
39.根据权利要求34所述的可植入脊椎盘主体，其特征在于，所述可植入脊椎盘主体至少部分由固定延伸件包围，所述固定延伸件具有与箍带部分相连的若干个上下突片，用于将所述可植入脊椎盘分别固定到相邻的上下椎骨表面。
40.根据权利要求34所述的可植入脊椎盘主体，其特征在于，所述上下表面被表面纹理覆盖，以促进与相邻椎体的连接。
41.根据权利要求34所述的可植入脊椎盘主体，其特征在于，所述上下表面带有许多小孔，以促进组织向内生长。
42.根据权利要求34所述的可植入脊椎盘主体，其特征在于，所述可植入脊椎盘主体前部的厚度大于后部。
43.一种生物相容的弹性体材料制成的可植入脊椎盘主体，其机械弹性模量小于大约100兆帕，极限抗拉强度超过大约100千帕，包括：
基本上是凹进的上表面，其周缘表面基本上是平直的；
基本上是凸出的下表面，其周缘基本上是平直的；
所述上下表面通过周缘表面相连；且
所述可植入脊椎盘主体的还具有的特征是，具有肾形，带有延伸的卵形表面和凹进部分，其横截面大体上是矩形的，且其前部的厚度大于后部。
44.根据权利要求43所述的可植入脊椎盘主体，其特征在于，所述上下表面沿高度的粗糙度指数在大约1纳米与大约2毫米之间，而周缘表面的粗糙度指数小于1毫米。
45.根据权利要求43所述的可植入脊椎盘主体，其特征在于，还包括：
固定延伸件的箍带部分，至少部分包围所述可植入脊椎盘主体的周缘表面；和
从所述固定延伸件的箍带部分延伸的若干个上下突片，用于将所述可植入脊椎盘主体分别固定到相邻的上下椎骨表面。
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