CN101952341A - 多孔的生物相容性聚合物材料和方法 - Google Patents
多孔的生物相容性聚合物材料和方法 Download PDFInfo
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- CN101952341A CN101952341A CN2009801039025A CN200980103902A CN101952341A CN 101952341 A CN101952341 A CN 101952341A CN 2009801039025 A CN2009801039025 A CN 2009801039025A CN 200980103902 A CN200980103902 A CN 200980103902A CN 101952341 A CN101952341 A CN 101952341A
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- polymer beads
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Abstract
所描述的实施方式包括用于形成多孔聚合物材料的器件和方法。所披露的并使用所描述的方法形成的器件包括用于脊柱融合的间隔体、颅颌面(CMF)结构体、和用于组织植入物的其它结构体。
Description
技术领域
本发明的结构体和方法涉及多孔聚合物材料和用于制造多孔聚合物材料和结构体的方法。实例结构体包括但不限于,脊柱融合的间隔体、颅颌面(CMF)结构体、用于骨骼替代的其它材料和结构体。
相关申请的交叉引用
本申请要求2008年2月1日提交的美国临时申请61/025,426的权益,该申请的全部内容在此通过引用纳入本申请。
背景技术
脊柱融合是用于治疗由椎间盘变质或椎间盘突出引起的慢性背痛的常见技术。该技术包括除去两块椎骨间的椎间盘并用椎间间隔体将其代替。该椎间间隔体保持上述两块椎骨之间的间距并优选通过该间隔体获得融合。该椎间间隔体可由取自患者自身骨骼的自生骨骼组织构成。异源间隔体由取自捐献者的骨骼构成。人工间隔体目前是最常见的间隔体类型,并且可由金属材料如钛或不锈钢、或聚合物如聚醚醚酮(PEEK)构成。
PEEK近来由于其生物相容性和导致对X射线和CT成像有限干扰的天然的辐射透明特性而变得流行。但是,虽然PEEK是生物相容性的,但骨骼在重塑过程期间将其视为异物,并用纤维组织囊将其隔离。这样的纤维组织阻止直接的骨沉积(apposition)和对植入物的附着。其它材料,如钛,允许直接骨沉积和长出(ongrowth),但它们典型地不是辐射透明的,并且变得难以评估融合的形成。
PEEK用作矫形生物材料的其它领域也出现了类似的纤维包囊。这样的情况包括,用于填充头盖骨和颅骨上的缺陷的定制加工体。与钛相比,使用PEEK时,MRI和CT成像通常更容易,但植入物永远不会完全结合到骨骼中并且软组织不会附着到该植入物上。
陶瓷材料如磷酸钙、β-TCP、羟基磷灰石等允许直接的骨沉积,非常像钛。但是,它们典型地在它们的强度和韧性上受到限制。因此,期望构造这样的材料,其将上述其它个别材料的期望性能更多地组合在一起,所述期望的性能如韧性和强度,对MRI、X射线或CT成像的较低干扰,组织附着等。
附图说明
当与附图结合阅读时,将更好地理解上述总述以及以下对本发明优选实施方式的详细说明。为了展示本申请的促进长入(ingrowth)/长穿(throughgrowth)的多孔聚合物体,在附图中示出了优选的实施方式。但是,应理解的是,本申请不限于所示的精确布置方式和手段。在附图中:
图1A展示了根据本发明实施方式的多孔生物相容性材料的顶视图。
图1B展示了根据现有技术的多孔生物相容性材料的顶视图。
图2展示了根据本发明实施方式的在表面上具有β-TCP的PEEK颗粒的平面顶视图。
图3展示了根据本发明实施方式的具有通孔的多孔间隔体的透视顶视图。
图4A、4B、和4C分别展示了根据本发明实施方式的具有实心芯的间隔体的平面正视图、截面透视正视图和分解正视图。
图5A、5B、和5C展示了根据本发明实施方式的具有实心带的间隔体的平面正视图、截面透视正视图和分解透视正视图。
图6A、6B、和6C展示了根据本发明实施方式的具有实心部分的另一种间隔体的透视顶视图、透视正视图、和透视分解顶视图。
图7A、7B、和7C展示了根据本发明实施方式的另一种间隔体的截面透视正视图、透视分解侧视图、和透视正视图。
图8展示了根据本发明实施方式的椎间盘关节成形术(disc arthroplasty)的全椎间盘替代植入物的透视正视图。
图9A、9B、和9C展示了根据本发明实施方式的间隔体和固定板的透视正视图、平面顶视图、和透视侧视图。
图10展示了根据本发明实施方式的包含仪器啮合部件(feature)的间隔体的透视侧视图和截面透视侧视图。
图11展示了包含根据本发明实施方式的多孔材料的腰椎间隔体的透视图和侧视图。
图12展示了包含根据本发明实施方式的多孔材料的另一种腰椎间隔体的透视图和侧视图。
图13展示了包含根据本发明实施方式的多孔材料的另一种腰椎间隔体的透视图和侧视图。
图14展示了包含根据本发明实施方式的多孔材料的另一种腰椎间隔体的透视图和侧视图。
图15展示了包含根据本发明实施方式的多孔材料的另一种腰椎间隔体的透视图和侧视图。
图16展示了包含根据本发明实施方式的多孔材料的另一种腰椎间隔体的透视图和侧视图。
图17展示了包含根据本发明实施方式的多孔材料的另一种腰椎间隔体的透视图和侧视图。
图18展示了包含根据本发明实施方式的多孔材料的另一种腰椎间隔体的透视图和侧视图。
图19展示了包含根据本发明实施方式的多孔材料的另一种腰椎间隔体的透视图和侧视图。
图20展示了包含根据本发明实施方式的多孔材料的另一种腰椎间隔体的透视图和侧视图。
图21展示了包含根据本发明实施方式的多孔材料的颈椎间隔体的透视图。
图22展示了包含根据本发明实施方式的多孔材料的另一种颈椎间隔体的透视图。
图23展示了包含根据本发明实施方式的多孔材料的另一种颈椎间隔体的透视图。
图24展示了根据本发明实施方式的多孔腰椎间隔体的透视正视图。
图25A和25B分别展示了根据本发明实施方式的多孔间隔体的平面侧视图和平面顶视图。
图26展示了显示图24的间隔体的抗压强度和孔隙率之间的关系的图。
图27展示了显示图25A-25B的间隔体的抗压强度之间的关系的图。
图28A和28B展示了根据本发明实施方式的具有实心芯的试样结构体的透视正视图。
图29展示了显示根据本发明实施方式的各种结构体的压缩模量(刚性)之间的差异的图。
图30展示了显示根据本发明实施方式的各种结构体的极限抗压强度的图。
具体实施方式
在本专利申请中描述了多种实施方式,并且所述实施方式只是以展示的目的给出。所描述的实施方式不以任何方式,也不想以任何方式进行限制。正如从披露的内容容易地看出的那样,当前所披露的发明广泛地适用于多种实施方式。本领域技术人员将认识到,所披露的发明可以以各种改型和改变如结构上的和化学上的改型来实施。虽然所披露的发明的特定特征可能是参考一种或多种特定实施方式和/或附图来描述的,但应理解的是,除非明确地指出,否则这些特征不限于只在描述它们的所参考的一种或多种特定实施方式或附图中使用。
在此公开的内容既不是所有实施方式的文字说明,也不是必须存在于所有实施方式中的本发明特征的罗列。
发明名称(位于本专利申请第一页的开头处)和摘要(位于本专利申请的末尾)均视作不以任何方式限制所披露的发明的范围。
参考图1和图2,其中展示了置于400℃炉子中5分钟的PEEK/β-TCP(磷酸三钙)混合物和仅仅PEEK材料在最终结构上的差异。具体地说,图1显示了可用于构成根据以下更详细描述的实施方式的多孔间隔体的PEEK颗粒。第一优选实施方式的颗粒包括PEEK/β-TCP混合物,其具有粒度范围在0.5-1.0mm以内的粒子,其中TCP在400摄氏度施用5分钟。
本文所述的本发明的主题涉及多孔或部分多孔体复合材料,其用于制造如脊柱融合间隔体的器件和矫形器件中的组织长入表面,并且还涉及制备和使用该多孔体的方法。
在一种实施方式中,给出了制造可用于脊柱融合的多孔椎间间隔体的方法。这里所述的多孔椎间间隔体包括部分地或全部地由复合材料制备的主体。在所选择的实施方式中,主体包括聚醚醚酮粒子,和覆盖该PEEK粒子的至少一部分的β-磷酸三钙(β-TCP)表面涂层。虽然PEEK是在一个实例中使用的聚合物,但本发明不限于此。其它实施方式采用不同于PEEK的各种热塑性塑料,或除PEEK之外还采用各种热塑性塑料,或采用聚合物的组合。
多孔间隔体实施方式提供了初始的稳定性,并最终允许从下脊骨和上脊骨进行骨骼长入。为了有良好的血管形成和骨骼长入,多孔间隔体的孔结构通常是互连的。在一个实例中,用水银孔隙度测定法测量平均孔径并且其优选在100-500μm的范围。100-500μm的范围不拟为限制性的,并且至少一部分孔可落在该范围之外。通常理解的是,为了允许哺乳动物组织长入,所述孔必须大到足以允许形成最低要求通过大约5-10μm的红细胞的血管网络,因此,这限定了至少一部分孔的期望孔径下限。因此,孔的较宽范围可为5-5000μm。
在一种实施方式中,使用本发明中所述的技术形成的多孔体进一步用患者的骨髓和/或血液浸渍。这些自体生物活性物质的使用可以提供细胞源和生长因子,所述细胞源和生长因子能够加速骨骼和组织形成到所述多孔结构体中和所述多孔结构体上,并且还能够帮助引导前体细胞沿着期望的路径分化(即干细胞变成形成骨骼的成骨细胞)。在一种实施方式中,所述多孔体用异体生物物质浸渍以赋予类似的效果。在所选择的实施方式中,浸渍了生物活性物质如生长因子,包括但不限于BMP II、BMP VII和PDGF。刺激骨骼或组织形成的合成小分子包含于一些实施方式中。所述小分子包括但不限于抑制素(statin)。虽然以上引述了单独的添加物质,但各种物质的组合也在本发明的范围内。
在一些实施方式中,改型所述多孔结构体以保留这些生物活性物质,并在长时间内释放它们或引导它们的释放和活性的位置。在一些实施方式中,所述多孔结构体用保持活性物质然后在期望的时间内释放该活性物质的物质涂覆。用于这样的涂层的材料包括但不限于以水解方式降解的材料,如脂族聚酯,如PLA和PGA,以及水凝胶如PEG和CMC。或者,在一些实施方式中,多孔结构体的表面或处理提供期望的释放动力学。这样的表面结构包括微孔性和改变表面润湿性。
在其它实施方式中,将生物活性物质涂布到单独的载体上,该载体涂布到或插入本发明的多孔体。在一种实施方式中,单独的载体被预插入到多孔体中。在一种实施方式中,多孔体被改型为具有孔隙率至少部分降低的区域以减少或阻止生物活性物质在某些方向上的释放。在一个实例中,无孔聚合物或其它材料的薄外壳置于多孔芯上以阻止生物活性物质在径向上的释放。这样的配置在其中生长因子如BMP II在径向上的释放可导致不期望的组织生长的颈椎融合中实现了优点。在所选择的实施方式中,无孔材料由能再吸收的材料制成,从而使方向上受控的释放有时间依赖性。
在一个实例方法中,具有特定粒度范围的聚合物粒子与β-磷酸三钙(β-TCP)混合以形成聚合物颗粒和涂覆粉末的混合物。在一种实施方式中,所述混合提供了在聚合物粒子表面周围的至少部分β-TCP涂层。可以用于涂覆聚合物的替代材料包括但不限于,钙粉、骨粉、羟基磷灰石、钛(包括钛合金和钛氧化物)、钡盐和氧化锆。将所述混合物置于温度高于聚合物熔点的一个或多个模子中,并保持在熔融聚合物粒子的接触点处有效形成粘结的时间。
在所选择的实施方式中,接下来除去涂覆聚合物表面的粉末,并获得微孔表面结构,该微孔得自之前由粉末涂覆粒子占据的体积。这种微孔结构的有效孔径为0.1~100微米。
在一个实例中,β-TCP粉末抑制、减缓、或在一些实施方式中阻止聚合物材料在高于熔融温度时的流动,并导致聚合物粒子成珠。最终产物为连续的多孔材料,其具体的几何形状大体上复制了模子的几何形状。聚合物材料的实例包括但不限于,PEEK、碳增强的PEEK、PEKK、PAEK族、PEK PEKK、PEKEKK、PCL、PLA、PGA、聚亚苯基、自增强的聚亚苯基、聚苯基砜、聚砜、PET、聚乙烯、聚氨酯或其它生物相容性聚合物。
在一些实施方式中,其它材料掺入多孔体。在一种实施方式中,聚合物粒子融合到整个增强结构体。该增强结构体可由任何已知的生物相容性材料(包括钛和不锈钢)或聚合物本身制成,并且可以为多孔体提供额外的机械强度。在另一种实施方式中,掺入辐射不透明的材料以提供选择性的辐射不透明性区域,从而可以用X-射线或CT可视化多孔体的位置。这些辐射不透明的材料包括但不限于,生物相容性金属(例如氮化钛铝(TAN)、钛铝钒(TAV)、钽、金、钡、钛、不锈钢)、硫酸钡、氧化锆和辐射不透明的染料。在其它实施方式中,辐射不透明的材料用于以机械方式增强多孔结构体。
在一些实施方式中,所述多孔结构体在选择性区域中被选择性地压缩以赋予提高的机械强度。这样的压缩通过热和/或压力的组合实现。产生这样的热和压力的方法包括但不限于,超声波、射频加热、感应加热、激光或直接加热。这些增强的区域可形成用于与仪器或结构肋啮合的部件。
示例性实施方式
多孔PEEK方法
一种方法实施方式产生了多孔椎间间隙。该方法实施方式包括使用粒子形式的聚合物。粒度在0.25-1.0mm的范围内。该范围不拟为限制性的,并且也可以使用其它粒度。所述粒子与β-TCP以90%聚合物、10%β-TCP的比例混合。β-TCP的粒度在0.01-0.1mm的范围内。将所述粒子置于容器中并充分混合。所述混合可以使用标准的实验室涡流振荡器进行。振荡允许较小的β-TCP粒子至少部分覆盖聚合物粒子的表面。用筛目尺寸大于β-TCP粒度但小于聚合物粒度的筛子除去过量的β-TCP粒子。得到的粉末混合物包括用β-TCP涂覆的聚合物粒子。β-TCP的目的是防止聚合物粒子在加热到高于熔点时自由流动。β-TCP的存在导致粒子成珠,并防止在聚合物的熔点或之上流动。这允许保持聚合物粒子之间的牢固粘结,同时保持间隙空间。当冷却时,最终材料限定了具有β-TCP涂层的互连的多孔聚合物。得到的材料具有用于骨骼长入的互连多孔结构和产生富含钙的表面的β-TCP涂层以进行更好的骨传导(osteoconduction)。
如上所述,在所选择的实施方式中,β-TCP或其它涂覆粉末稍后从孔中暴露的表面通过酸沥滤(选择性的溶剂工艺)或另一种粉末除去工艺除去。在这种情况中,所述表面缺少钙,但具有就润湿性和细胞附着而言是有利的微孔结构。
图1A和1B展示了置于400℃的炉子中5分钟的PEEK/β-TCP混合物和仅含PEEK的材料在最终结构上的差异。图1A展示了使用上述方法形成的β-TCP在表面上的互连样品。模子内混合粒子的粒度和量决定了孔隙率。最终模子的几何形状决定了最终多孔组件的尺寸和形状。
图1B展示了没有使用涂覆粒子如β-TCP时在相同温度和时间下的PEEK粒子的坍塌结构。从以上各图中可以看出,当在使混合物熔融前包含涂覆粒子如β-TCP时,更大程度地保留了间隙空间。与标准烧结方法相比,这里描述的方法实施方式以较快的加工时间允许较强的粘结。因为烧结包括在熔点之下加热材料,粒子之间的粘结不如通过在熔点之上加热粒子而粘结的材料那样坚固。
图2展示了通过在熔融前混合90%的PEEK和10%的β-TCP来用β-TCP粉末涂覆的PEEK聚合物粒子。将该混合物置于250μm的筛子中以除去过量的β-TCP粉末。得到的粉末由覆盖有β-TCP粉末的PEEK颗粒组成,如图2所示。
虽然在以上示例性实施方式中描述了涂覆有β-TCP粉末的PEEK聚合物,但本发明不限于此。涂覆有其它粉末粒子的其它聚合物也在本发明的范围内。得到本发明益处的本领域技术人员将认识到,利用其它聚合物和其它涂覆粉末,可以调节其它加工条件如加热温度和时间等以使用替代的材料形成多孔聚合物结构体。
整块多孔结构体
多孔PEEK结构体的一种实施方式是完全由多孔PEEK制成的用于椎间体融合的假体(prosthesis),如图3、11、和12A-12B所示。假体可以呈现多种外部形状的形式以优化端板(endplate)覆盖。上表面和下表面可包括为了提高器件在椎间间隙中的初始稳定性而模制的锥形或单向的凸牙或隆起。一些实施方式(其中之一为图3中的间隔体30)限定了一个或多个轴向孔32以允许实心的骨骼长穿。在一种实施方式中,在间隔体30的侧面34上进一步提供侧窗以通过放射照相或其它合适的技术加强对融合的评估。虽然图3中显示的是大体为圆柱体形状作为整块多孔结构体实例,但其它整块多孔几何形状如实心圆柱、支架(scaffold)形状、复杂的定制模制配合形状等也在本发明范围内。
实心芯
图4A、4B和4C展示了用于椎间体融合的植入物40。该植入物40由热粘结到多孔端板44的PEEK实心芯42构成。该植入物实施方式40用于提高该植入物的极限轴向抗压强度,同时保持骨骼长入和初始稳定性的益处。
图5A、5B和5C展示了植入物实施方式50,其包括多孔PEEK主体52和围绕主体52以环形方式定位的实心带54。
实心植入物夹持器
在椎间体器件的常规植入期间,期望外科医生保持对植入物的精确控制。这种控制中的一个重要部分是通过紧密地夹持植入物而实现的。期望的是夹持和释放步骤不使间隔体的引入轮廓以任何显著的方式增加或发生其它改变。
在图6A、6B和6C中,植入物夹持部件62集成到该植入物实施方式60的以机械方式与多孔组件66连接的实心部分64。机械连接的实例包括:配合到相应插槽中的接片63。虽然显示了接片63,但其它机械连接的配置如其它过盈配合几何形状,卡口紧固等也在本发明的范围内。图6A、6B和6C的实施方式显示了从该植入物一侧68的下表面延伸到上表面的实心部分64,通过增强多孔组件66,该植入物可以定位成承载最大的轴向载荷以及提高该植入物的剪切强度。
在所示的实施方式中,夹持部件62包括一对插槽。在一种实施方式中,一对插槽如插槽62配置成与外科医生的工具面接以提供精确的控制。本领域技术人员将认识到,多种其它可能的夹持部件配置如单一插槽、凸出部件等在本发明的范围内。
图7A、7B和7C展示了夹持部件72的另一种实例。在图7A-C的实例中,夹持部件72集成到植入物70的实心芯74中。类似于上述实施方式,该植入物70由包括夹持部件72的实心部分74和使用以上实施方式中所述的方法形成的多孔聚合物部分76组成。
图10展示了另一种实例实施方式100,其包括集成到实心部分104的外部几何体中的植入物夹持器部件102,所述实心部分104粘结到多孔体106。从所述各实例可以看出,提出了植入物和夹持部件的多种可能的配置。
用于椎间盘关节成形术的器件上的多孔端板部件
图8展示了用于椎间盘关节成形术的椎间假体的一种实施方式80,其包括热粘结到具有横向插入槽86的实心PEEK 84的多孔PEEK端板82。
多组件构造
图9A、9B和9C展示了具有集成的固定装置的椎间间隔体90的一种实施方式,其中显示了热粘结到实心PEEK芯94并机械连接到金属板96的多孔PEEK端板92。中心牵张器(distractor)槽辅助插入。
脊椎间隔体的实例配置
图11-20展示了包含使用本发明所述的方法形成的至少一部分多孔聚合物材料的腰椎间隔体的多种实例配置。虽然显示了若干实例,但本发明不限于此。在各实例中,整个间隔体可由所述多孔聚合物材料形成,或者仅一部分间隔体可由所述多孔聚合物材料形成。如本文所述,其它材料配置包括粘结到、以机械方式接合到、或以其它方式连接到多孔部分的实心部分。实例实心部分包括连接到多孔聚合物部分的实心芯、实心带、实心皮等。
图21-23展示了包含使用本发明所述的方法形成的至少一部分多孔聚合物材料的颈椎间隔体的多种实例配置。类似于腰椎间隔体的讨论,使用多孔聚合物材料的多种配置在本发明的范围内。采用如上所述的实心材料部分的配置也包含在内。
图11显示了包括至少一部分多孔聚合物材料的间隔体110。图12显示了包括至少一部分多孔聚合物材料的间隔体120。图13显示了包括至少一部分多孔聚合物材料的间隔体130。图14显示了包括至少一部分多孔聚合物材料的间隔体140。图15显示了包括至少一部分多孔聚合物材料的间隔体150。图16显示了包括至少一部分多孔聚合物材料的间隔体160。图17显示了包括至少一部分多孔聚合物材料的间隔体170。
图18显示了包括至少一部分多孔聚合物材料的多组件间隔体180。第一部分182、第二部分184和第三部分186显示为连接在一起。在所示的实施方式中,各部分使用机械连接件188连接。在一个实例中,机械连接件包括如图所示的楔形榫配置。虽然楔形榫是简单有效的机械连接件,但本发明不限于此。机械连接件188的其它几何形状在本发明的范围内。
图19显示了包括至少一部分多孔聚合物材料的间隔体190。图20显示了包括至少一部分多孔聚合物材料的间隔体200。图21显示了包括至少一部分多孔聚合物材料的间隔体210。图22显示了包括至少一部分多孔聚合物材料的间隔体220。
图23显示了包括至少一部分多孔聚合物材料的多组件间隔体230。第一部分234和第二部分236显示为使用机械连接件236连接到一起。类似于上述间隔体180,在一个实例中,所述机械连接件236包括楔形榫布置或类似的机械连接件。
附加的表面制备
本发明所描述的实施方式根据期望的最终性能还可以包括各种精整工艺。一种附加的表面处理包括用离子化的氧或其它气体进行等离子体处理。在所选择的实施方式中,这样的等离子体处理改变表面化学以提高润湿性。另一种表面处理包括羟基磷灰石(HA)涂层以提高植入物表面的骨传导潜力。另一种表面处理包括磷酸钙涂层以提高植入物表面的骨传导潜力。另一种表面处理包括氮化钛涂层以提供骨骼长出所期望的表面。提供骨骼长出所期望的表面的其它表面处理包括通过多种工艺中的任一种涂布的钛或其它生物相容性金属或氧化物涂层,所述工艺如物理气相沉积、化学气相沉积等。
替代的设计实施方式
附加的实施方式包括将较大的、离散的β-TCP、钛或其它骨传导粒子掺入涂覆粉末混合物。这些较大的骨传导粒子具有大约与热塑性材料相同的大小。在所选择的实施方式中,离散的骨传导粒子增强已涂覆有β-TCP粉末的多孔材料的骨传导性能。骨传导粒子的一种来源包括Synthes制造的CronOSTM。
替代的应用
如上所述,多孔材料的其它用途包括用于除了脊椎间隔体之外的组织长入应用的支架。以上实施方式中所述的多孔材料还可在处于生理机械应力的解剖学位置中期望骨骼长入的多种应用中用作骨骼空隙填料。除脊椎间隔体之外的应用的实例包括制造适合用于颅或颅面缺陷修复的至少一部分植入物。
对于上述脊椎间隔体实例中所述的那些之外的应用来说,可期望改变多孔聚合物的机械性能,如模量、剪切强度等。改变聚合物和/或涂覆粉末导致根据期望的不同的机械性能。在所选择的实施方式中,改变多孔聚合物结构体性能使得它们适于软组织长入。
替代的材料/涂层
本发明的一些间隔体实施方式的主体、或其部分是由PEEK聚合物或其它聚合物形成的。除了各种聚合物的选择,还可以选择除β-TCP之外的涂覆粉末材料。替代的粉末如硫酸钡(BaSO4)或碳酸锶(SrCO3)在加热到高于熔点期间对聚合物具有与β-TCP类似的效果。
机械测试
参考图24和25A-25B,多孔PEEK间隔体是通过将上述PEEK/β-TCP粉末置于模子中产生的。置于模子内的粉末混合物的量决定了最终结构体的空隙率。粒子的粒度范围决定孔径。使具有不同表面积和高度的两种类型的样品形成几何形状与本领域中已知的那些类似的间隔体。测试最终样品的抗压强度。图26展示了显示图24的间隔体的抗压强度和空隙率之间的关系的图,而图27展示了显示图25A-25B的具有40%空隙率的间隔体的抗压强度和所述间隔体的高度之间的关系的图。
参考图28A-28B,制备与完全多孔的样品不同的复合材料样品,其中实心PEEK圆柱体夹在两个多孔PEEK端盖(endcap)之间。实心芯赋予该复合材料较高的抗压强度,并且多孔端盖允许骨骼从上部和底部脊骨长入。图29是显示完全由多孔PEEK形成的间隔体、由实心PEEK间隔体形成并具有多孔PEEK端板的间隔体(如图28A-28B中展示的间隔体)、完全由实心PEEK形成的间隔体、和完全由网状骨骼形成的间隔体的压缩模量(刚性)之间的差异的图。图30展示了显示完全由多孔PEEK形成的间隔体、由实心PEEK形成并具有多孔PEEK端板的间隔体(如图28A-28B中展示的间隔体)、和完全由实心PEEK形成的间隔体的极限抗压强度的图。
虽然描述了本发明的多种实施方式,但上述实例不是穷举的。对本发明的具体实施方式的前述说明已为了展示的目的进行了详细描述。根据说明和展示,本领域的其它技术人员可以通过应用当前的知识容易地对本发明进行改型和/或调整以用于各种应用而不会出离本发明的基本理念;因此,这样的改型和/或调整在所附权利要求的含义和范围内。
Claims (33)
1.形成多孔聚合物材料的方法,包括:
形成聚合物颗粒和涂覆粉末的混合物;
其中涂覆粉末粒子比所述聚合物颗粒小;
其中所述涂覆粉末粒子不在所述聚合物颗粒的熔融温度熔化;
将所述混合物加热到高于所述聚合物颗粒的熔融温度的温度;
由于所述涂覆粉末控制熔融聚合物的流动,使得基本保持所述混合物中的间隙空间;和
冷却所述混合物,在经涂覆的聚合物颗粒的接触点处形成粘接。
2.权利要求1的方法,进一步包括在所述混合物已冷却后通过所形成的孔基本上除去所述涂覆粉末。
3.权利要求1的方法,其中形成所述多孔聚合物材料包括使用所述多孔复合材料形成用于脊柱融合的间隔体。
4.权利要求1的方法,其中形成聚合物颗粒和涂覆粉末的混合物包括形成聚醚醚酮(PEEK)颗粒和涂覆粉末的混合物。
5.权利要求4的方法,其中形成聚合物颗粒和涂覆粉末的混合物包括形成聚醚醚酮(PEEK)颗粒和陶瓷涂覆粉末的混合物。
6.权利要求5的方法,其中形成聚合物颗粒和涂覆粉末的混合物包括形成聚醚醚酮(PEEK)颗粒和包括β-磷酸三钙(β-TCP)的涂覆粉末的混合物。
7.权利要求6的方法,其中形成聚合物颗粒和涂覆粉末的混合物包括形成约90重量%的聚醚醚酮(PEEK)和约10重量%的β-磷酸三钙的混合物。
8.权利要求1的方法,其中形成聚合物颗粒和涂覆粉末的混合物包括形成聚合物颗粒和选自硫酸钡(BaSO4)和碳酸锶(SrCO3)的涂覆粉末的混合物。
9.权利要求1的方法,其中形成所述多孔聚合物材料包括使用所述多孔聚合物材料形成颅颌面(CMF)结构体。
10.权利要求1的方法,进一步包括使用离子化的氧对所述多孔聚合物材料的表面进行等离子体处理。
11.权利要求1的方法,进一步包括用羟基磷灰石涂覆所述多孔聚合物材料的表面。
12.权利要求1的方法,进一步包括用磷酸钙涂覆所述多孔聚合物材料的表面。
13.权利要求1的方法,进一步包括用氮化钛涂覆所述多孔聚合物材料的表面。
14.权利要求1的方法,其中形成聚合物颗粒和涂覆粉末的混合物包括,选择聚合物材料以使所述多孔复合材料的机械性能匹配相邻组织的相应的机械性能。
15.权利要求14的方法,其中机械性能包括弹性模量。
16.用于促进骨骼长入的多孔结构体,包括:在接触点处熔融到一起的聚合物颗粒的网络;在聚合物颗粒之间的多个间隙空间;和基本上排列于间隙空间内的聚合物颗粒表面的粒子涂层。
17.权利要求16的多孔结构体,其中所述结构体为用于脊柱融合的间隔体。
18.权利要求16的多孔结构体,其中所述结构体为颅颌面(CMF)结构体。
19.权利要求16的多孔结构体,其中所述结构体为支架结构体。
20.权利要求16的多孔结构体,其中所述多孔结构体是组合结构体的一部分,在该组合结构体中,多孔部分在多孔/实心界面连接到实心部分。
21.权利要求20的多孔结构体,其中所述多孔部分以机械方式固定到所述实心部分。
22.权利要求20的多孔结构体,其中所述组合结构体包括夹层结构体,在所述夹层结构体中,多孔部分粘结在两侧且所述实心部分夹在其间。
23.权利要求22的多孔结构体,进一步包括夹持部件,该夹持部件形成为所述实心部分的一部分以便于放置该组合结构体。
24.用于促进骨骼长入的多孔结构体,包括:
在接触点处熔融到一起的聚合物颗粒的网络;
所述颗粒上的微孔表面结构,和
在所述聚合物颗粒之间的多个间隙空间。
25.权利要求24的多孔结构体,其中所述微孔表面结构的孔径基本上在0.1~100μm的范围内。
26.权利要求24的多孔结构体,其中所述微孔表面结构的孔径基本上在1~50μm的范围内。
27.权利要求24的多孔结构体,其中所述结构体为用于脊柱融合的间隔体。
28.权利要求24的多孔结构体,其中所述结构体为颅颌面(CMF)结构体。
29.权利要求24的多孔结构体,其中所述结构体为支架结构体。
30.权利要求24的多孔结构体,其中所述多孔结构体是组合结构体的一部分,在所述组合结构体中,多孔部分在多孔/实心界面连接到实心部分。
31.权利要求30的多孔结构体,其中所述多孔部分以机械方式固定到所述实心部分。
32.权利要求30的多孔结构体,其中所述组合结构体包括夹层结构体,在所述夹层结构体中,多孔部分粘结到两侧且所述实心部分夹在其间。
33.权利要求32的多孔结构体,进一步包括夹持部件,该夹持部件形成为所述实心部分的一部分以便于放置该组合结构体。
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- 2009-01-30 EP EP09707751.5A patent/EP2238192B1/en not_active Not-in-force
- 2009-01-30 BR BRPI0906750A patent/BRPI0906750B8/pt not_active IP Right Cessation
- 2009-01-30 CN CN200980103902.5A patent/CN101952341B/zh not_active Expired - Fee Related
- 2009-01-30 CN CN201610108443.1A patent/CN105754132B/zh not_active Expired - Fee Related
- 2009-01-30 WO PCT/US2009/000604 patent/WO2009099559A2/en active Application Filing
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- 2009-01-30 KR KR1020107018979A patent/KR101618887B1/ko active IP Right Grant
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2013
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2016
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CN105848611A (zh) * | 2013-12-24 | 2016-08-10 | 尼普洛株式会社 | 支架 |
US10137014B2 (en) | 2013-12-24 | 2018-11-27 | Nipro Corporation | Stent |
CN105848611B (zh) * | 2013-12-24 | 2019-01-29 | 尼普洛株式会社 | 支架 |
WO2015184696A1 (zh) * | 2014-06-03 | 2015-12-10 | 深圳兰度生物材料有限公司 | 人工椎间盘及其制备方法 |
CN104958100A (zh) * | 2015-05-25 | 2015-10-07 | 创生医疗器械(中国)有限公司 | 一种椎弓根螺钉用防旋顶丝 |
CN105233335A (zh) * | 2015-11-06 | 2016-01-13 | 四川大学 | 一种具有生物活性的多孔聚芳醚酮材料及其制备方法与应用 |
CN105233335B (zh) * | 2015-11-06 | 2018-07-13 | 四川大学 | 一种具有生物活性的多孔聚芳醚酮材料及其制备方法与应用 |
CN106178105A (zh) * | 2016-08-29 | 2016-12-07 | 上海交通大学 | 一种表面多孔的医用聚醚醚酮及其制备方法和应用 |
CN106178105B (zh) * | 2016-08-29 | 2019-12-10 | 上海交通大学 | 一种表面多孔的医用聚醚醚酮及其制备方法和应用 |
CN110393610A (zh) * | 2019-05-15 | 2019-11-01 | 上海大学 | 一种三层复合骨植入假体及其制备方法 |
CN110393610B (zh) * | 2019-05-15 | 2021-08-10 | 上海大学 | 一种三层复合骨植入假体及其制备方法 |
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US20200139014A1 (en) | 2020-05-07 |
KR101618887B1 (ko) | 2016-05-09 |
US20110045087A1 (en) | 2011-02-24 |
CA2711403C (en) | 2016-08-09 |
AU2009210750A1 (en) | 2009-08-13 |
US8530560B2 (en) | 2013-09-10 |
US11679181B2 (en) | 2023-06-20 |
US10549014B2 (en) | 2020-02-04 |
CA2711403A1 (en) | 2009-08-13 |
JP2011511128A (ja) | 2011-04-07 |
WO2009099559A3 (en) | 2010-03-25 |
CN101952341B (zh) | 2016-03-23 |
US20140207237A1 (en) | 2014-07-24 |
EP2238192A2 (en) | 2010-10-13 |
CN105754132B (zh) | 2019-12-10 |
CN105754132A (zh) | 2016-07-13 |
BRPI0906750B1 (pt) | 2019-12-10 |
US20160184483A1 (en) | 2016-06-30 |
KR20100120173A (ko) | 2010-11-12 |
US9308297B2 (en) | 2016-04-12 |
BRPI0906750B8 (pt) | 2021-07-27 |
BRPI0906750A2 (pt) | 2015-07-07 |
EP2238192B1 (en) | 2017-03-01 |
JP5726536B2 (ja) | 2015-06-03 |
WO2009099559A2 (en) | 2009-08-13 |
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