CN102341131A - 脊柱融合器 - Google Patents
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Abstract
本发明涉及一种用于植入两根相邻椎骨之间的脊柱融合器,其中在负荷下整个融合器的最大压缩高于脊柱融合器初始高度的0.05%,并且最大压缩不会改变融合器的结构完整性。
Description
本发明涉及一种脊柱融合器,用于制备脊柱融合器的方法以及包含该脊柱融合器的脊柱融合系统。
脊柱融合术,也被称为脊柱制动术(spondylodesis或spondylosyndesis),是用于将两根或更多根椎骨连接在一起的外科技术。脊柱融合术最常在腰部脊柱上进行,但是也用于治疗颈和胸椎问题。脊柱融合术有两个主要手术途径,可以相互结合使用:
●后外侧融合术通过后入路或外侧入路将骨移植物置于椎骨之间。然后通过使螺杆和/或丝线穿过与椎骨每一面上的金属棒相连的每一根椎骨的椎弓根而将这些椎骨适当地固定。
●椎间融合术将骨移植物置于椎骨之间通常由椎间盘占据的区域。为脊柱融合术做准备时,椎间盘被完全移除。融合器可以被置于椎骨之间从而维持脊柱序列和椎间盘高度。椎间融合器可以由聚合物材料制成或者由钛制成。然后在椎骨的终板之间发生融合。
●同时使用这两种融合术的被称为360°融合术。融合率比椎间融合术高。
手术后融合过程通常花费6-12个月。在此期间,可能需要外部支撑(矫正器械)。
脊柱融合系统在现有技术中是已知的,并且通常由脊柱外科医生使用,用于使相邻的椎骨保持在预期的位置上的同时进行脊柱融合。
脊柱融合系统可以脊柱融合器组成,其被置于两根相邻的椎骨之间从而有助于脊柱融合。脊柱融合系统还可以由与两根相邻椎骨相连的棒或板组成,从而实现椎骨之间相互固定,并且还可以由脊柱融合器与棒或板的组合组成。本发明涉及只包含脊柱融合器或者包含脊柱融合器与棒或板的组合的脊柱融合系统。
最常用的脊柱融合系统由金属(诸如钛或钴铬合金)制成,或者由常用于生物医用植入物的聚合物(聚醚醚酮(PEEK))制成。这些植入材料的模量远高于骨的模量,并且存在植入物下陷和移位的临床证据,这被认为归结于天然骨与植入材料的力学不相容性。由于存在这些金属植入物,还发生骨头压力性坏死。
基于来自供体(同种异体移植物)或来自病人自身(自体移植物)的骨材料的植入物具有不一致的机械强度并且随时间显示出下陷。这些植入物的不一致的性能使得它们对于可靠地加工的来说通常不可预料、具有挑战性,并且特别易于迁移和排出,因为难以将齿状物一致地加工到上下植入物的接触面中。
例如US2005/0049706公开了多孔陶瓷材料,其试图提供机械性能可与骨相比的脊柱融合系统。但是这些植入物仍是由非常刚硬的材料制成。这些脊柱融合系统不可压缩,仍将导致下陷至骨中。
US 2005/0246021和EP1818024分别描述了由多孔聚合物材料或其上有孔的聚合物材料制成的脊柱融合器。这些融合器是由可生物再吸收聚合物材料(例如PLA)制成,这些材料的缺点是由于身体的再吸收性,材料的机械性能不稳定。这些聚合物材料本身是不可压缩的。使用多孔聚合物材料的目的是:能以可控的方式将材料压缩从而在材料内创建各种结构配对体。在负荷下多孔融合器以及有孔融合器的高度将永久性减小。因此这些脊柱融合器不能被设计来承受负载,在负载状态下将(进一步)显示出永久变形。
因此,仍需要一种生物稳定的脊柱融合器,其拉伸模量与骨相当,不会下陷并且能提供良好的稳定性。
根据本发明提供了这样的脊柱融合器。
本发明的生物稳定的脊柱融合器被植入在两根相邻的椎骨之间,在负荷下整个融合器的最大压缩高于脊柱融合器初始高度的0.05%,最大压缩不会改变融合器的结构完整性。
融合器的初始高度和压缩后的高度都用mm表示。脊柱融合器的初始高度是:没有在脊柱融合器上施加任何负荷时,脊柱融合器与一根椎骨的接触面和同一脊柱融合器与相邻椎骨的另一个接触面之间最短的距离。
压缩后的高度是:在相当于2MPa应力水平的负荷作用在融合器接触面的机械压缩条件下脊柱融合器的高度(以mm计)。2MPa已经高于人体椎骨骨小梁的压缩屈服强度(Kopperman,D.L.,Biomechanics 31,601-608),从而提供产生不期望的融合器向骨内下陷的边界条件。
当施加在脊柱融合器接触面上的负荷导致融合器发生机械变形时,便达到融合器的压缩后的高度。只有在融合器的测试期间才能使融合器达到压缩后的高度,且通常不会在人体或其他动物体中出现的条件下达到压缩后的高度。机械变形不会导致融合器的失效或永久变形。
最大压缩是初始高度和在相当于2MPa应力水平的负荷作用在融合器的接触面时的压缩后的高度之间的差(以mm计)。
高于脊柱融合器初始高度的0.05%的最大压缩是比常规材料(诸如金属、陶瓷或PEEK)的最大压缩还大的压缩。优选地,最大压缩大于脊柱融合器初始高度的0.1%。
优选地,最大压缩小于脊柱融合器初始高度的12%;更优选地小于脊柱融合器初始高度的10%
最大压缩是在向脊柱融合器施加负荷时脊柱融合器的变形的量度。脊柱融合器必须足够坚固以承受人体或动物体的负荷以及承受身体的正常运动而不会失效。脊柱融合器还必须具有柔韧性从而能吸收由运动引起的人体或动物体的震动,不会下陷到椎骨中或者不会使椎骨之间的融合器排出。
脊柱融合器的较高的最大压缩可以例如通过设计特征或通过使用更软或更像橡胶的材料而实现。脊柱融合器可以例如由金属、陶瓷和/或聚合物制成。设计特征可以包含于脊柱融合器中。这些包括但不限于弹簧、线圈等,它们允许脊柱融合器被压缩。
优选地,脊柱融合器包含生物稳定的聚合物材料。
脊柱融合器中所用的聚合物材料可以是均聚物、共聚物、嵌段共聚物和无规共聚物。聚合物可以选自例如聚烯烃类、聚酯类、聚酰胺类、聚氨酯类和弹性体类。
优选地,聚合物材料的拉伸模量低于3500MPa,该拉伸模量低于骨的拉伸模量。
此处和下文中所定义的拉伸模量是根据ISO 527测定的模量。
脊柱融合器可以包含一种或更多种聚合物材料或者包含聚合物材料与一种或更多种其他材料(诸如金属或陶瓷)的组合。
根据本发明一个优选的实施方式,脊柱融合器包含一种聚合物材料,该脊柱融合器的较高的最大压缩例如是通过如下得到的:通过使聚合物材料发泡、通过使用熔融沉积成型(FDM,fused deposition molding)来制备脊柱融合器、通过使一定量的抗冲改性剂或增塑剂与聚合物材料混合或通过为脊柱融合器设计特征。此外,选择性激光烧结(SLS)和其他快速造型技术也可以用于制备脊柱融合器。
可以根据本领域普通技术人员已知的方法来制备聚合物材料的泡沫。通过使用物理和/或化学发泡剂可以使聚合物材料转化为发泡的融合器或融合器部件。泡沫可以是开孔泡沫或闭孔泡沫。
通过使用FDM或SLS,可以制备出具有根据本发明的最大压缩的预定三维结构融合器。
抗冲改性剂是能与聚合物材料混合从而改善聚合物材料的抗冲击性的化合物。抗冲改性剂可以例如是能与聚合物基质相容的官能化的弹性材料。抗冲改性剂的实例是在聚烯烃中被用作抗冲改性剂的弹性聚合物(例如Kraton)。
增塑剂是使添加其的材料的塑性或流动性增大的添加剂。最常用的增塑剂是邻苯二甲酸酯。
优选地,脊柱融合器中的聚合物材料是至少部分发泡的。
根据本发明的另一个实施方式,脊柱融合器包含多于一种的材料。
例如,可以是金属或陶瓷与拉伸模量非常低的材料的组合。
优选地,脊柱融合器包含多于一种的聚合物材料以及
-至少一种聚合物材料的拉伸模量介于0.001和<1.0GPa之间;
-至少一种另外的聚合物材料的拉伸模量高于其他聚合物材料的拉伸模量;
-聚合物材料相互化学或物理连接。
根据该实施方式,脊柱融合器中使用了至少两种不同的聚合物材料。这些聚合物材料具有不同的模量。
聚合物材料可以从上述的聚合物材料中选择。聚合物材料在脊柱融合器中作为分立的零件或部件存在。该零件或部件由拉伸模量介于0.001和<1.0GPa之间或拉伸模量高于其他聚合物材料的的聚合物材料制成。优选地,具有较高拉伸模量的聚合物材料的拉伸模量介于1.0和20GPa之间。在零件或部件中,具有上述拉伸模量的不同聚合物材料可以混合,但是一个零件或部件不可以既包含拉伸模量介于0.001和<1.0GPa之间的聚合物材料又包含拉伸模量介于1.0和20GPa之间的聚合物材料。
不同的聚合物材料相互之间化学或物理连接。这表示:不同聚合物材料之间可以存在例如共价键、离子键、氢键或范德华键。这些键防止存在于脊柱融合器中的两种聚合物材料的分离。还可以用胶粘剂或能使形成脊柱融合器的不同聚合物材料粘接的其他材料将不同的聚合物材料连接在一起或者通过用于连接不同聚合物材料的机械结构将不同的聚合物材料连接在一起。
优选地,具有较高的拉伸模量的聚合物材料是聚酯。优选地,聚酯的拉伸模量介于1.0和20GPa之间,更优选地拉伸模量介于1.5和3GPa之间。
聚酯可以是热塑性或热固性聚酯。热固聚酯也被称为热固性树脂,是不可逆固化的聚酯材料。可以通过加热(通常高于150℃)、通过化学反应或辐照来进行固化。热塑性聚酯也被称为热软化塑料,是被加热时变成液体而充分冷却时凝固为玻璃态的聚合物。大多数的热塑性塑料是高分子量的聚合物,其链通过弱的范德华力结合。热塑性聚酯不同于热固性聚合物,因为和热固性聚合物不同,它们可以再熔化并重塑。
聚酯可以是均聚物或共聚物。也可以使用不同类型聚酯的混合物。
聚酯的实例为聚对苯二甲酸乙二醇酯(PET)、聚对苯二甲酸丁二醇酯(PBT)、聚萘二甲酸乙二醇酯(PEN)和聚(萘二甲酸环己烷二甲醇酯)(PCT)。
优选地,聚酯是热塑性聚酯。在此处和说明书的下文中聚碳酸酯被理解为一种聚酯。
优选地,拉伸模量介于0.001和<1.0GPa之间的聚合物材料是包含硬相和软相的热塑性弹性体(TPE)。更优选的是拉伸模量为10-1000MPa的TPE。
热塑性弹性体(TPE)是(嵌段)共聚物或聚合物的物理混合物,其由既有热塑性又有弹性的聚合物材料组成。商业上存在6种通用类型的TPE。它们是苯乙烯类嵌段共聚物、聚烯烃类混合物、弹性体合金(TPE-v或TPV)、热塑性聚氨酯(TPU)、热塑性共聚酯(TPC)和热塑性聚酰胺。TPE产品的实例是Styroflex(BASF)、Kraton(Shell)、Pellethane(Dow)、Pebax(Arkema)、Arnitel(DSM)、Hytrel(Du Pont)、Santoprene(Monsanto)、Geolast(Monsanto)、Sarlink(DSM)、Alcryn(Du Pont)等等。
优选地,热塑性弹性体选自热塑性共聚酯(TPC)和热塑性聚氨酯(TPU)。
术语“热塑性聚氨酯(TPU)”包括通常含有三种主要组分的聚合物系列。三种主要组分是巨二醇、二异氰酸酯和扩链剂。通常将它们归类为聚氨酯,因为其主链上包含氨基甲酸酯基并且通常也包含脲基团,这些基团是聚合物主链上的重复单元。一般针对聚氨酯中的具体的巨二醇组分,通常三个主要系列的巨二醇目前都是可商购的。它们是聚酯二醇、聚醚二醇和聚碳酸酯二醇。
优选地,TPE包含硬相和软相,其中硬相包含可以选自由聚酯、聚酰胺、聚苯乙烯、聚丙烯酸酯和聚烯烃组成的组中的聚合物;而软相包含选自由聚醚、聚酯、聚丙烯酸酯、聚烯烃和聚硅氧烷组成的组中的聚合物。
TPE中的硬相包含熔融温度(Tm)或玻璃化转变温度(Tg)高于35℃的刚性聚合物相。TPE中的软相包含Tg低于35℃、优选低于0℃的柔性、无定形聚合物相。在干燥的样品上测定Tm和Tg。
优选地,TPE具有包含与拉伸模量介于1.0和20GPa之间的聚合物材料相同的聚合物的硬相。例如,拉伸模量介于1.0和20GPa之间的聚烯烃与具有聚烯烃硬相的TPE组合。
根据本发明所用的TPE包含例如上述硬相聚合物与软相聚合物的混合物以及嵌段共聚物。硬相和软相可以被包含于一种聚合物,也可以由两种或更多种上述聚合物材料的混合物组成。
优选地,根据本发明所用的TPE是嵌段共聚物。当TPE是嵌段共聚物时,脊柱融合器中所用的TPE包含含有硬嵌段和软嵌段的聚合物,其中硬嵌段包含选自由聚酯、聚酰胺、聚苯乙烯、聚丙烯酸酯和聚烯烃组成的组中的聚合物;软嵌段包含选自由聚醚、聚酯、聚丙烯酸酯、聚烯烃和聚硅氧烷组成的组中的聚合物。
TPE嵌段共聚物的实例是嵌段共聚酯酯、嵌段共聚醚酯、嵌段共聚碳酸酯酯、嵌段聚硅氧烷酯、嵌段共聚酯酰胺、包含聚对苯二甲酸丁二醇酯(PBT)硬嵌段和聚四氢呋喃软嵌段的嵌段共聚物、包含聚苯乙烯硬嵌段和乙烯丁二烯软嵌段(SEBS)的嵌段共聚物、包含聚对苯二甲酸丁二醇酯(PBT)硬嵌段和聚碳酸酯软嵌段的聚氨酯。
还存在包含硬和软聚合物嵌段的聚氨酯嵌段共聚物。例如US4739013、US 4810749、US 5133742和US 5229431中描述了通常已知的聚氨酯嵌段共聚物以及这些共聚物的制备方法。这些聚氨酯嵌段共聚物具有硬的聚碳酸酯相,并且是生物稳定的。
TPE中的硬嵌段由上述Tm或Tg高于35℃的刚性聚合物组成。原则上,上述各种聚合物都可以用作硬嵌段。
酯、酰胺、苯乙烯、丙烯酸酯和烯烃的共聚物也可以用作硬聚合物嵌段,只要硬聚合物嵌段的Tm或Tg高于35℃。
优选地,TPE的至少一个相(即硬相或软相)包含聚酯。更优选地,拉伸模量介于0.001和<1.0GPa之间的聚合物材料是具有聚酯硬嵌段的TPC。
已发现:关于它们(特别是具有聚酯硬嵌段的TPC或TPC)在本发明的脊柱融合器中的使用具有很多优点,包括低蠕变、低压缩永久形变、高尺寸稳定性和高抗湿性。在此处和说明书的下文中,聚碳酸酯被理解为一种聚酯。
在包含硬的聚碳酸酯嵌段的TPC或TPU中,硬嵌段由衍生自至少一种亚烷基二醇和至少一种芳族二元羧酸或其酯的重复单元组成。亚烷基通常包含2-6个碳原子,优选地2-4个碳原子。优选地,可用作亚烷基二醇的是乙二醇、丙二醇,并且特别是丁二醇。对苯二甲酸、2,6-萘二甲酸和4,4’-联苯二羧酸非常适合用作芳族二元羧酸。也可以使用这些二元羧酸和/或其他二元羧酸(诸如间苯二甲酸)的组合。它们的作用是影响结晶行为,例如硬聚酯嵌段的熔点。
最优选地,硬嵌段是聚对苯二甲酸丁二醇酯。
TPC或TPU中的软嵌段由上述Tg低于35℃的柔性聚合物组成。原则上,上述聚合物都可以用作软嵌段。同样醚、酯、丙烯酸酯、烯烃和硅氧烷的共聚物也可用作软聚合物嵌段,只要软聚合物嵌段的Tg低于35℃。
优选地,软嵌段包含聚酯或聚醚;更优选地是脂肪族聚酯或聚醚。包含聚酯或聚醚软嵌段的TPC或TPU特有的优点是:脂肪族聚酯和聚醚的具有化学稳定性高的特征。特别地,碳酸亚烷基酯和脂肪族聚醚优选作为软嵌段,这将使得TPC或TPU具有特别低的湿度敏感性和良好的粘附性。优选地,TPC或TPU中的软嵌段衍生自至少一种碳酸亚烷基酯和可选地由衍生自脂肪族二醇和脂肪族二元羧酸的重复单元制成的聚酯。
碳酸亚烷基酯可以由式表示
其中R=H、烷基或芳基;x=2-20。
优选地,R=H且x=6,因此该碳酸亚烷基酯是碳酸六亚甲基酯。
优选地,脂肪族二醇单元衍生自链中含有2-20个碳原子、优选地3-15个碳原子的亚烷基二醇和含有2-20个碳原子、优选地4-15个碳原子的亚烷基二元羧酸。
更优选地,软嵌段包含聚碳酸酯。
最优选地,TPC包含含有聚对苯二甲酸丁二醇酯的硬嵌段和含有聚碳酸酯的软嵌段。可选地,用二异氰酸酯使TPC扩链。
例如在Handbook of Thermoplastics,Ed.O.Otabisi,Chapter 17,MarcelDekker Inc.,New York 1997,ISBN 0-8247-9797-3,Thermoplastic Elastomers,2nd Ed.,Chapter 8,Carl Hanser Verlag(1996)ISBN 1-56990-205-4和theEncyclopedia of Polymer Science and Engineering,Vol.12,pp-75-117(1988),John Wiley & Sons以及其中所含的参考文献中描述了嵌段共聚酯酯的实例及制备。
脊柱融合器被植入在两根相邻的椎骨之间。因此存在于融合器中的至少一种聚合物材料与这些椎骨中的每一根相接触。
优选地,拉伸模量介于0.001和<1.0GPa之间或拉伸模量介于1.0和20GPa之间的聚合物材料以层的形式存在于脊柱融合器中。这些层以如下方式定向:使脊柱融合器承受的负荷转移到融合器中存在的不同层上。换言之,一根椎骨和另一根椎骨之间存在不同的聚合物材料的层。
更优选地,聚合物材料以材料层的形式存在,并且具有较高拉伸模量的聚合物材料被插入两个拉伸模量介于0.001和<1.0GPa之间的聚合物材料的层之间。
脊柱融合器中层的组成的例子为:聚丙烯(作为拉伸模量较高的材料)与TPV(Sarlink)(作为拉伸模量较低的材料)组合;聚酰胺(作为拉伸模量较高的材料)与热塑性聚酰胺(作为拉伸模量较低的材料)组合;聚酯(作为拉伸模量较高的材料)与TPC(作为拉伸模量较低的材料)组合;以及聚酯(作为拉伸模量较高的材料)与TPU(作为拉伸模量较低的材料)组合。
脊柱融合器可以通过多种不同的方式制备。可以通过使聚合物材料成型的任何一种已知的方法来制备聚合物材料的零件或部件。已知的技术包括(共)注射成型、(共)挤出成型、吹塑成型、注射覆盖成型、MuCell微孔发泡注射成型、板的共挤出或通过分解助剂(如柠檬酸)产生注射成型泡沫。
可以使用的其他方法是快速造型技术,诸如选择性多层烧结和熔融沉积成型。
在包含多于一种聚合物材料的脊柱融合器中,由不同聚合物材料制成的零件或部件可以通过例如胶结、焊接或模制而结合在一起。
优选地,多组分模塑成型被用于制备包含多于一种聚合物材料的脊柱融合器。
多组分模塑成型也被称为“双色”或“多色”注射成型。这是一种在单个模具中组合两种或更多种材料的技术。多组分模塑成型使得制备包含硬和软零件或具有不同性能零件的设计产品成为可能。可以使用如下的多种方法:
多色覆盖成型是在一个模具中使一种塑料在另一种塑料上模塑的方法。该方法非常精确,因为零件从未离开模具。不同材料间的粘附性比较大,因为进行覆盖成型时基材仍然很热。良好的粘附性防止脊柱融合器零件的分离,脊柱融合器零件的分离可能导致多种并发状况,包括融合器迁移、因融合器迁移导致的血管和/或神经损伤。
多进程成型是在同一模具中用不同材料制造不同零件的成型方法。当两个零件一起使用时(例如经焊接的组件),这可能特别有用。
模内组装类似于多进程成型,仅使用模具中的机构来组装不同的零件(几何学允许下)并且每一个周期中制备一个组装件。
夹层模塑,有时被称为“共注射”,是一种材料被注射通过另一种材料的液态熔体,从而形成其外面是另一种材料皮的芯材料的过程。
脊柱融合器可以单独作为脊柱融合系统使用或者与其它融合器组合使用。融合器还可以与一根或更多根棒组合从而实现脊柱融合。
棒可以例如由金属或聚合物材料制成。
优选地,棒包含聚合物材料。通过这种方式,使得脊柱融合系统中的棒的拉伸模量也能与骨的拉伸模量相当;该拉伸模量低于3500MPa。
更优选地,棒包含至少两种不同的聚合物材料从而使棒更柔韧并且能够牢固地固定到椎弓根螺钉中。
下文中将通过下面非限制性的实施例说明本发明。
实施例
材料
●PEEK:来自Eriks的KetronPEEK-1000
实施例1
本实施例的目的是比较由不同材料制成的脊柱融合器。
下面实验中描述的所有融合器都具有长方形的(18x 10x 6mm3)开口箱型结构,壁厚为1.5mm。测试了由六种不同类型的材料制成的融合器:
a.PEEK(对比实验);
d.UHMWPE
在下文中被称为2Kb融合器。
通过如下进行实验:
1.通过静态测试测定融合器的机械性能
植入后融合器必须具有足够的强度来承受峰值负荷。通过准静态加载测试测定空融合器的强度和刚度。
根据ASTM2077-03进行实验。根据该同一指导,加载速度为13mm/min。每一个实验中测试三个融合器(n=3)。
2.在静态和动态加载方式下测定向骨内的下陷
根据ASTM 2267测定融合器向骨层内的下陷,使用聚氨酯泡沫(等级15,ASTM 1893)作为可再现的骨层模拟器。因为植入物和骨层之间的不一致性似乎是融合器的负荷量和下陷的重要参数,将一个泡沫层加工成半径为28mm的曲面。另一个泡沫层保持平坦。首先,对于所有类型的融合器来说,测定空融合器在泡沫层上的静态强度。在约450N的负荷下泡沫似乎失效。接着,将等于该静态强度70%(即:300N)的静负荷施加在两个聚氨酯块及其之间的融合器上10分钟。其次,以2Hz的频率施加50-300N的动态负荷100,000个周期(约15h)。在两个空的融合器(最差情况)之间作比较。每种融合器材料的样品数为3(n=3)。
排出实验
根据Goel等人在Summer Bioengineering Conference,Key Biscayne,Florida,2003年6月中描述的测试来进行排出测试。在300N的预加负荷和0.4mm/s的恒定速度下,在被夹在两个平的聚氨酯泡沫块(等级15,ASTM 1893)之间的融合器上进行排出测试。所有融合器类型的样品数为3(n=3)。
结果
表1中给出了实验结果。
n.d.=没有测定
所有融合器都足够坚固,被认为在动物和人体中足以承受体内负荷(约等于体重的10倍)。
令人惊讶地,TPE、UHMWPE和2Ka、2Kb融合器在排出/迁移方面显示出显著的改善。
此外,两种2K融合器在下陷方面也显示出改善。
静态和动态下陷实验表明:2K融合器在这一方面的表现也很好:与“硬的”PEEK融合器相比,其下陷比PEEK融合器低超过20%。2K融合器的摩擦导致最高的排出强度。
最后,2K融合器表现出显著的两个刚度范围的行为;首先是约为1.0kN/mm的非常低的刚度,随后是可与TPE融合器相比的刚度。TPE、UHMWPE和2K融合器的刚度的数量级比PEEK融合器低;这可以刺激在体内情形中融合器内的骨生长。
Claims (15)
1.一种用于植入两根相邻椎骨之间的脊柱融合器,其中在负荷下整个融合器的最大压缩高于所述脊柱融合器的初始高度的0.05%,并且最大压缩不会改变所述融合器的结构完整性。
2.如权利要求1所述的脊柱融合器,其中最大压缩低于所述脊柱融合器的初始高度的12%。
3.如权利要求1或2所述的脊柱融合器,其包含生物稳定的聚合物材料。
4.如权利要求3所述的脊柱融合器,其中所述聚合物材料的拉伸模量低于3500MPa。
5.如权利要求1-4中任意一项所述的脊柱融合器,其中所述融合器包含发泡的聚合物材料。
6.如权利要求1-5中任意一项所述的脊柱融合器,其中存在多于一种的聚合物材料,以及
-至少一种聚合物材料的拉伸模量介于0.001和<1.0GPa之间;
-至少一种另外的聚合物材料的拉伸模量高于其他聚合物材料的拉伸模量;
-所述聚合物材料相互化学或物理连接。
7.如权利要求6所述的脊柱融合器,其中所述另外的聚合物材料的拉伸模量介于1.0和20GPa之间。
8.如权利要求7所述的脊柱融合器,其中拉伸模量介于1.0和20GPa之间的所述聚合物材料是聚酯。
9.如权利要求6-8中任意一项所述的脊柱融合器,其中拉伸模量介于0.001和<1.0GPa之间的所述聚合物材料是具有聚酯硬嵌段的热塑性弹性体材料。
10.如权利要求1-9中任意一项所述的脊柱融合器,其中所述聚合物材料以一个或多个材料层的形式存在。
11.如权利要求6-10中任意一项所述的脊柱融合器,其中所述聚合物材料以多个材料层的形式存在,并且具有较高拉伸模量的所述聚合物材料被插入两个拉伸模量介于0.001和<1.0GPa之间的所述聚合物材料的层之间。
12.用于制备权利要求6-11中任意一项所述的脊柱融合器的方法,其中通过多组分模塑成型将不同的聚合物材料结合在一起。
13.包含权利要求1-11中任意一项所述的脊柱融合器的脊柱融合系统。
14.如权利要求13所述的系统,其还包含聚合物材料棒。
15.一种用于治疗哺乳动物的脊柱的方法,其包括:将权利要求1-11中任意一项所述的脊柱融合器插入包含退变性、损伤或缺失脊椎盘的脊柱区域中。
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PCT/EP2009/052643 WO2009109645A2 (en) | 2008-03-05 | 2009-03-05 | Load-bearing bone implant comprising a thermoplastic elastomer |
EPPCT/EP2009/052643 | 2009-03-05 | ||
EP09169519.7 | 2009-09-04 | ||
EP09169519 | 2009-09-04 | ||
PCT/EP2010/052854 WO2010100267A1 (en) | 2009-03-05 | 2010-03-05 | Spinal fusion cage |
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CN102341131A true CN102341131A (zh) | 2012-02-01 |
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EP (1) | EP2403548A1 (zh) |
JP (1) | JP2012519516A (zh) |
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EP2403548A1 (en) | 2012-01-11 |
WO2010100267A1 (en) | 2010-09-10 |
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