CN101076302A - 椎间盘髓核的补充或替换 - Google Patents

椎间盘髓核的补充或替换 Download PDF

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CN101076302A
CN101076302A CNA2005800313541A CN200580031354A CN101076302A CN 101076302 A CN101076302 A CN 101076302A CN A2005800313541 A CNA2005800313541 A CN A2005800313541A CN 200580031354 A CN200580031354 A CN 200580031354A CN 101076302 A CN101076302 A CN 101076302A
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implant
passage
biocompatible materials
intervertebral disc
pressure
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爱德华·沃斯洛维克
迈克尔·F·凯恩
托马斯·P·斯切尔
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Synthes GmbH
HFSC Co
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Abstract

通过一种方法补充或替换退变的髓核，该退变的髓核位于纤维环(108)内的椎间盘(106)的中央核心(110)区域中，在所述方法中，将一定量的生物相容性材料引入中央核心区域是通过包括以下步骤的过程实现的：1)形成贯穿与所述椎间盘相邻的椎骨体(102)的通道(116)，该通道从椎骨体的外表面延伸至纤维环的中央核心区域；2)经由该通道将一定量的生物相容性材料引入纤维环的中央核心区域；3)经由该通道将生物相容性材料加压到足以缓解退变的髓核造成的症状的术后压力；以及4)密封该通道，同时保持所述足够大的术后压力。

Description

椎间盘髓核的补充或替换
相关申请的交叉参考
本申请要求2004年7月27提交的美国临时专利申请第60/591,094号的权益，在此将其所有公开内容并入本文作为参考。
技术领域
本发明涉及通过穿骨法(transosseus approach)用粘弹性低模量植入物来替换或补充椎间盘的天然髓核的方法和装置，更具体地涉及用于对椎间盘内的粘弹性植入物进行加压，以使环张力和髓核加压达到适当生理状态的方法和装置。
背景技术
很多人都患有慢性背痛(通常是下背痛)，慢性背痛会使人们耽误很多工作时间并耗费大量的治疗费用。这种疼痛一般是由因为损伤或与年龄有关的退变造成的椎间盘的病理状况所引起的。
当前治疗下背痛的选择范围包括从保守性的卧床休息到高侵害性的外科手术程序，包括脊柱融合术和摘除术。脊柱融合术，即融合或固定患病椎间盘每侧的椎骨，是一种减轻疼痛、提高融合节段稳定性的方法。摘除术，即通过外科手术去除椎间盘的一部分，是另一种可选的外科手术。
利用医用假体进行的整个椎间盘替换术已被推荐作为减轻背痛的另一种选择，而且推荐了大量这样的医用假体。
人类椎间盘包括两个主要结构，即内部的凝胶状髓核和外部的腱结构，即纤维环。髓核的退变会使椎间盘机能退降和丧失，造成疼痛和功能丧失。因此，减轻下背痛的另一种可选的外科手术是对髓核进行替换，使环保持原样。因此，髓核替换的目标是要减轻疼痛，使椎间盘恢复健康的生理机能，并防止在环上产生额外的磨损。
正常的椎间盘机能需要髓核和纤维环联合作用。因此，为了使环纤维的张力回复到它们的天然状态，髓核植入物优选应该有助于恢复椎间盘的正常活动能力，恢复椎间盘的高度，并重建健康的椎间盘压力。
因此，需要一种髓核替换装置和植入方法，该装置和植入方法基本上再现了髓核和环之间的协同相互作用，从而恢复椎间盘正常的机械性质和活动能力。
发明内容
根据本发明，可以通过一种包括如下步骤的方法替换或补充椎间盘纤维环的中央核心内包含的退变的髓核：
1)形成贯穿与所述椎间盘相邻的椎骨体的通道，所述通道从所述椎骨体的外表面延伸至所述纤维环的所述中央核心；
2)经由所述通道将一定量的生物相容性材料引入所述纤维环的所述中央核心；
3)经由所述通道将所述生物相容性材料加压到足以缓解所述退变的髓核所造成的症状的生理压力；以及
4)密封所述通道，同时保持所述压力。
因此，在本发明的一个方面中，提供了一种用于替换或补充退变的髓核的方法。
另一方面，本发明提供了一种用于将生物相容性材料引入椎间盘纤维环的中央核心的方法。
另一方面，本发明提供了一种用于将水凝胶或其它模量较低的材料引入椎间盘纤维环的中央核心的方法。
另一方面，本发明提供了一种用于将加压植入物引入椎间盘纤维环的中央核心的方法。
另一方面，本发明提供了一种对髓核进行植入物移植的外科手术法，该方法避免了对所述环造成的损伤。
另一方面，本发明提供了一种通过上椎骨体或下椎骨体对髓核进行的穿骨法。
另一方面，本发明提供了一种封闭椎骨体中的通道的方法，该方法将髓核替换物压缩到纤维环的中央核心中，以保证完全填充了所述核心。
另一方面，本发明提供了一种用于天然椎间盘的髓核的替换物或补充物，其被设计成与所述环协同工作，以再现正常的椎间盘机械性能。
另一方面，本发明提供了一种经过替换或经过补充的髓核的术后结构，其能再现(至少近似地再现)正常的人类椎间盘的机械性质。
另一方面，本发明提供了一种能改进退变的的椎间盘髓核机能的植入物。
根据下面对本发明所作的描述，本发明的其它方面将是明显的。
附图说明
图1是人类脊柱的机能性脊柱运动单元(即带有上椎骨和下椎骨的椎间盘)的侧向前视横截面，其以图解方式说明了本发明的穿骨法中的第一步骤，即，利用引导丝钻出进入路径；
图2是机能性脊柱运动单元的截面图，其以图解方式说明了穿骨法中的第二步骤，即，利用中空的钻头进行超钻；
图3是机能性脊柱运动单元的截面图，其以图解方式说明了穿骨法中的第三步骤，即，经由插入鞘移植植入物；
图4是机能性脊柱运动单元的截面图，其以图解方式说明了穿骨法中的第三和第四步骤的一种实施方案，即，利用骨栓塞和螺钉回填低模量材料植入物并对其加压；
图5是机能性脊柱运动单元的横截面图，其以图解方式再次说明了本发明的穿骨法中的第三和第四步骤；
图6是机能性脊柱运动单元的截面图，其以图解方式说明了穿骨法中的第三和第四步骤的另一种实施方案，即，利用楔形植入物回填低模量材料植入物并对其加压；
图7示出了在一个按本发明的方法移植了假体的脊柱运动节段上执行的一系列屈伸测试的结果。
发明的详细描述
根据本发明，补充或替换椎间盘髓核的植入物通过穿骨法穿过相邻椎骨移植。
在一种优选方式中，本发明的这一方法包括以下步骤：
1)形成贯穿与所述椎间盘相邻的椎骨体的通道，所述通道从所述椎骨体的外表面延伸至所述纤维环的所述中央核心；
2)经由所述通道将一定量的生物相容性材料引入所述纤维环的所述中央核心；
3)经由所述通道将所述生物相容性材料加压到足以缓解所述退变的髓核所造成的症状的生理压力；以及
4)密封所述通道，同时保持所述压力。
在本发明的优选实施方案中，相对较软的低模量植入物(即，具有低的无约束压缩模量)通过穿骨法被插入和加压穿过相邻椎骨。下文将按照这种优选实施方案描述本发明。本领域技术人员将认识到，本发明的穿骨法可以被用来插入用于髓核的任何合适的假体。
根据本发明的优选实施方案，在第一步骤中，形成贯穿与所述椎间盘相邻(即直接在其上或其下)的椎骨的通道，植入物将被插入到该通道中。可利用任何钻通骨结构(例如椎骨)的常规外科技术来形成这个穿过椎骨的通道。
钻成该通道之后，若需要，通过去除一部分或所有的天然髓核来准备手术部位。这种去除可通过常规外科技术来完成。其后，经由穿过椎骨的通道插入一定量的生物相容性材料(优选为模量相对较低的材料)，该材料足以填充椎间盘的中央核心，并提供至少接近天然椎间盘机能所要求的必要椎间盘高度和椎间盘压力。
适于替换或补充髓核的生物相容性材料的优选实施方案是固体的、富含水的水凝胶，如Vresilovic等人2005年5月23日提交的待批准美国专利申请第11/134,309号中所公开的，在此将该专利申请的所有公开内容并入本文作为参考。在本发明的方法中使用的另一种优选生物相容性材料是热凝胶化聚合物，其能够以一种相对的流体状态注入，以填充去除或退变的髓核的空隙，然后在体温下转变为固体凝胶，如Lowman等人2004年4月30日提交的待批准美国专利申请第10/837,082号中所公开的，在此将该专利申请的所有公开内容并入本文作为参考。这两种材料均能在本发明的方法中用来提供假体，以替换或补充天然髓核，并在椎间盘内建立基本的生理压力状态。这样的生物相容性材料能够不受病人解剖学上天然变异的影响，充分填充椎间盘髓核区域中的空隙体积而替换或补充髓核。本发明的方法能够利用本文描述的密封件精确地对这些生物相容性材料加压。
能够由本发明的方法施用和加压的生物相容性材料的进一步的实施方案包括这样的材料：其可用作组织工程化结构的骨架，并且能够结合可促进椎间盘结构(例如髓核、环或椎骨终板)再生的细胞、生长因子和其它生物材料。可用于这类结构的某些常规材料可以具有足够的流动性，以能够按照本发明的方法进行移植，因而其可以被移植并同时避免对纤维环产生损伤和使随后排出的可能性减至最小。此外，由于Liu等人，Spine 2001，Vol.26，第134页；Handa等人，Spine 1997，Vol.22，第1085页；以及Grukber等人，Spien 2003，Vol.28(2)，第186页(在此将它们的所有公开内容并入本文作为参考)中所作的体外研究已经揭示了椎间盘的细胞机能对压力敏感，本发明的方法能够提供施用生物学功能性假体，同时使随后排出的危险减至最小，并为调节移植后压力作好准备以促进细胞生长和机能的起始和维持的程序。
通过将密封件插入穿过椎骨的通道，对被插入的材料进行加压，或至少使其维持在该压力下。该密封件密封了通道，防止所述材料泄漏。因此，该密封件可被插入在所述植入物的末端，以维持移植设备所施加的压力，或者，随着其被推进穿过椎骨的通道到其最终的密封位置，该密封件本身可以对被植入的材料施加压力。在一种优选实施方案中，该密封件包括其后跟有机械栓塞的骨接合剂栓塞，该机械栓塞被推进到通道中，从而对被移植到中央核心中的材料施加适当的压力。该机械栓塞可以是常规的外科手术骨螺钉。或者，所述穿过椎骨的通道可以由其后跟有倒刺栓塞或楔形物的骨接合剂栓塞或其它生物相容性材料制成的栓塞密封，其中该倒刺栓塞或楔形物在力的作用下进入通道，从而提供必须的椎间盘内压力。作为骨接合剂或其它生物相容性材料的替代物，可以将一团材料压入通道，以对所述植入物加压，而且如上所述，利用骨螺钉、倒刺栓塞等等来密封通道。在另一种实施方案中，所述密封元件可由骨传导或诱导性生物材料制成的骨栓塞和/或螺钉或楔形物来提供。
正如本领域中所公知的，常规骨螺钉能够根据施加在该螺钉上的转动圈数在轴向上移动一精确距离。每转前进的距离可由螺钉的节距确定。因此，使用这种螺钉就有可能通过以一种精确方式抵靠住被植入的生物相容性材料推进该螺钉的远端，从而准确地调节空隙内的压力。可选择螺距、长度、牙型高度以及远端几何形状的各种组合来实现每转所需的灵敏度，并使植入物-螺钉界面处的磨损减至最小。
用于密封所述穿过椎骨的通道的骨接合剂可以是任何常规的生物相容性骨接合剂。这样的骨接合剂包括聚甲基丙烯酸甲酯、磷酸钙、硫酸钙、碳酸钙、羟基磷灰石等等。可选择地，可以使用天然生物材料，例如自体移植物、同种异体移植物或异种移植物。
本发明的方法的其它实施方案包括椎骨成形程序，该程序在移植了替换或补充髓核的生物相容性材料后执行。在这种可选择的实施方案中，通过上文所述的穿骨法进入椎间盘的髓核区域，如果需要，可去除髓核材料以形成空隙，植入生物相容性材料以替换或补充髓核，然后将一个相对较小的密封元件(例如小的骨螺钉)固定在形成椎骨终板外壳的皮质骨上。然后，如此进行基本上常规的椎骨成形：通过椎骨成形中所用的常规程序在螺钉后面的骨中形成空隙，并用常规的生物相容性骨填充物来填充如此形成的空隙。这种其后接着进行椎骨成形的髓核替换或补充方法可能会有利于对椎骨体强度有所下降的年龄较大的病人进行的髓核替换。
图1-6显示了应用本发明以在椎间盘的中央核心内提供加压植入物。图1-4和图6是侧向前视图，它们以局部截面图的形式示出了如何将模量较低的材料植入椎间盘的中央核心。图5是一个平面剖视图，其以局部截面图的形式示出了如何将该植入物植入椎间盘的中央核心。
图1和图2示意性地显示了一种用于形成穿过椎骨的通道的程序。图1以局部截面图的形式示出了脊柱运动节段或单元，该脊柱运动节段或单元包括上椎骨102和带有椎间盘的下椎骨104，该椎间盘被整体地标示为106且具有纤维环108和包含髓核的中央核心110。作为应用本发明的方法和假体的指征，占据着中央核心110的天然髓核会存在某些病理状况(例如退变的、突出等等)，或者会因这种病理状况而被整个地或至少部分地去除。图1示出了第一步骤，其中利用引导丝112从椎骨102的外部至中央核心110钻出通道路径。图2示出了第二步骤，其中利用中空的钻头114对引导丝112进行超钻，从而形成延伸入中央核心110的通道116。在经由通道116到达中央核心110后，利用适于通过狭窄通道116进行的常规外科手术程序在中央核心110内准备用于接收植入物的手术部位。
图3示出了下一个步骤，其中鞘118已被插入通道116中，而植入物120正穿过鞘118进入中央核心110。
图4-6显示了对椎间盘中央核心110内的植入物进行加压。
图4示出了本发明一种实施方案的侧向截面图，其中第一数量122的低模量材料120(例如水凝胶)已被插入到中央核心110中。图5示出了大致沿图4中的线V-V的图4脊柱单元的上截面的平面图。骨螺钉126已被插入所述通道，以完成将植入物120插入到中央核心110中，并将其中的低模量材料120在压力下密封。骨螺钉126可延伸通过整个通道116，或者，如图所示，其可延伸到通道116的一部分中并通过保持在通道116内的第二数量的生物相容性密封材料124(例如，可以是骨接合剂或另一团低模量材料)施加压力。该生物相容性密封材料能够包括诸如自体移植物、同种异体移植物或异种移植物之类的常规生物材料。
图6是本发明另一种实施方案的侧向截面图，示出了一种替代性方法，其通过将适当的栓塞(例如倒刺栓塞128)驱入通道116中来加压和密封中央核心110内的植入物120。任何其它合适的栓塞(例如膨胀栓塞等)能够被用来密封通道116，并对中央核心110内的植入物120加压。
可根据本发明的方法植入任何生物相容性材料。优选地，用来替换或补充退变的髓核的生物相容性材料是低模量材料，即，材料具有的压缩模量的范围为从约10kPa至约4MPa，优选从约50kPa至约1Mpa，更优选地从约100kPa至约200kPa。该生物相容性低模量材料为了执行其功能优选具有相对较高的泊松(Poisson)比，这如下所述。这种相对较高的泊松比的范围在约0.30至约50、优选从约0.40至约0.50，更优选地从0.45至约0.50。
本发明优选实施方案的生物相容性低模量材料可具有无毒的生物相容性化学成分。例如，可使用硅酮聚合物、聚氨酯和水凝胶材料。将这类材料用于可植入的假体是已知的，技术人员可根据其已知性质选择合适的材料。用于植入纤维环的中央核心中以替换或补充髓核的优选低模量、高泊松比材料为水凝胶，例如聚乙烯醇-聚乙烯基吡咯烷酮(PVA-PVP)共聚物或缔合的(associating)共混聚合物，例如聚乙烯醇和聚乙烯基吡咯烷酮的混合物。当在一个方向上压缩时，这种软水凝胶将会在与压缩方向大致成直角的方向上膨胀。这种称为泊松效应的现象能够有效地模拟在椎间盘遭遇的各种加载情形期间，健康的液体状髓核压靠周围纤维环内壁的正常加压。能够重现这种效应的任何生物相容性水凝胶或其它低模量材料均适于用在本发明的方法中。优选地，该生物相容性低模量材料具有不大于约4Mpa且处于上文定义范围内的压缩模量。其它合适的水凝胶聚合物例如包括以下文献中公开的材料：Ray等人，美国专利6,132,465；Ray等人，美国专利6,602,291；Bao等人，美国专利5,976,186；Bao等人，美国专利6,280,475；Marcolongo等人，美国专利申请第10/111,782号(欧洲专利第1229873号)；Stoy，美国专利6,264,495；Husson，美国专利5,919,235；McGuckin，美国申请公开第2003/0199979号；Trieu，美国专利6,620,196；Studer，PCT申请公开第WO03/084444A1号和美国专利申请公开第2005/0119750号；以及Breslave等人，法国专利2712486，在此将它们的所有公开内容并入本文作为参考。
可将水凝胶或其它低模量材料以任何合适形式引入纤维环的中央核心。髓核替换或补充材料的一种优选外形为能插入通过直径小于5mm的狭窄通道(例如在相邻椎骨中钻出的小孔)的细圆柱形。用于被插入的低模量材料的替代性优选形状包括能插入通过狭窄通道(其直径优选小于5mm)的大致的球形或椭球形。本发明的方法还可植入那些引入髓核区域并在其中固化形成低模量材料的可固化材料，以及上文提到的Marcolongo等人的美国专利申请第10/111,782号中所公开的缔合聚合物类型。
本发明的实施将通过下面的例子进行说明，该实施例仅是说明性的，而非限制性的。
实施例
本实施例阐述了按照本发明的方法填充脊柱运动节段的髓核空隙。发明人进行的各种研究描述了水凝胶中的泊松效应及其在模拟髓核与环相互作用中的正常协同机械性能方面的实用性。为了获得适当的机械性能，对椎间盘核心容积的适当填充是关键。
通过实施本发明替换髓核的方法进行了屈曲性实验。为了显示髓核的模拟退变的和恢复，在该方法的各个步骤中测量了脊柱运动节段或单元的屈曲性。选择L4/L5脊柱运动节段的适当样本，包括L4和L5腰椎骨以及其间带有完好纤维环和髓核的椎间盘。所选样本具有基本上正常的髓核。通过利用纯力矩(pure moments)进行一系列模拟屈伸，在髓核替换程序之前、之中、之后的四个阶段对样本进行屈曲性测量。测定了所限定的屈伸角度的范围所需的扭矩。结果示于图7中的曲线图，该曲线图示出了屈伸中扭矩与转动度数的关系。
四个屈伸系列中的第一个是对完好健康的椎间盘进行的，结果示于曲线1中。然后按照如下通常的常规程序来去除髓核，在该程序中用一个适合尺寸的环钻通过去除一块圆柱状的骨从而在一个相邻椎骨中形成轴向孔，通过如此形成的孔去除髓核，然后重新插入该圆柱状骨并将其粘牢就位，以基本上恢复椎骨结构。这样的程序基本上类似于如下文献中所描述的程序：Joshi等人，Journal of Biomedical Engineering，2005年6月，Vol.127；第536-540页，在此将其所有公开内容并入本文作为参考。然后通过相同的作用力矩来测试该样本。相应地，第二系列模拟了严重退变的的髓核，结果示于曲线2中。钻出一个贯穿该样本脊柱运动单元的上椎骨的进入通道，并将水凝胶植入物分两阶段植入该样本。在第一阶段，将制备成细绳(直径约为3mm)的水凝胶植入物通过插入在钻出通道中的鞘植入该样本，植入的量部分填充髓核去除后留下的容积。根据Marcolongo等人的美国专利申请公开第2004/0220296号的教导制备水凝胶。因此，该部分恢复的脊柱运动节段模拟了某种程度退变的髓核或未加压的替换髓核。当测试如此恢复的脊柱运动节段时，发现其朝该运动范围上正常生理值方向移动，如曲线3所示。最后，当将水凝胶完全植入该样本，并且根据本发明通过插入骨螺钉将核心完全填充并加压时，发现其接近于完全恢复了椎间盘的机械性能，如曲线4所示。
虽然已根据某些优选实施方案描述了本发明，但应该理解的是，可对其作出修改和变化，而不偏离本发明的精神和特征。

Claims (28)

1.一种用于替换或补充椎间盘中的髓核的方法，所述椎间盘具有纤维环，该纤维环具有含所述髓核的中央核心，所述方法包括：
形成贯穿与所述椎间盘相邻的椎骨体的通道，所述通道从所述椎骨体的外表面延伸至所述纤维环的所述中央核心；
经由所述通道将一定量的生物相容性材料引入所述纤维环的所述中央核心；
经由所述通道对所述生物相容性材料施加压力；和
密封所述通道，同时保持所述压力。
2.根据权利要求1所述的方法，其中所述压力足以至少大致地恢复所述椎间盘的天然机能。
3.根据权利要求1所述的方法，其中所述压力足以至少大致地恢复天然椎间间隔。
4.根据权利要求1所述的方法，其中所述生物相容性材料被加压到接近所述髓核的天然压力的压力。
5.根据权利要求1所述的方法，其中所述生物相容性材料具有不大于约4Mpa的压缩模量。
6.根据权利要求1所述的方法，其中所述生物相容性材料是水凝胶。
7.根据权利要求6所述的方法，其中所述水凝胶包括选自聚乙烯醇和缔合水凝胶的材料，该缔合水凝胶是聚乙烯醇和聚乙烯基吡咯烷酮的混合物。
8.根据权利要求1所述的方法，其中所述生物相容性材料选自聚氨酯和硅酮。
9.根据权利要求1所述的方法，其中所述通道是利用由生物相容性密封材料制成的栓塞来密封的。
10.根据权利要求9所述的方法，其中所述生物相容性密封材料选自骨接合剂、自体移植物、同种异体移植物和异种移植物。
11.根据权利要求10所述的方法，其中所述骨接合剂选自聚甲基丙烯酸甲酯、磷酸钙、硫酸钙、碳酸钙和羟基磷灰石。
12.根据权利要求1所述的方法，其中所述通道是利用由生物相容性密封材料制成的栓塞和机械栓塞来密封的。
13.根据权利要求12所述的方法，其中所述机械栓塞选自骨螺钉和倒刺栓塞。
14.根据权利要求1所述的方法，其中所述植入物是通过将骨螺钉或倒刺栓塞插入到所述通道来加压的。
15.根据权利要求1所述的方法，所述方法还包括以下步骤：在密封所述通道后，在所述椎骨体中进行椎骨成形。
16.一种用于椎间盘的复原植入物，包括：
一定量的生物相容性材料，其被植入到人类椎间盘的中央核心中以替换或补充髓核，所述量的生物相容性材料可经由在相邻椎骨中形成的通道进入；和
栓塞，其被设置在所述通道中，并对所述量的被植入的低模量材料施加压力。
17.根据权利要求16所述的植入物，其中所述术后压力足以至少大致地恢复所述椎间盘的天然机能。
18.根据权利要求16所述的植入物，其中所述术后压力足以至少大致地恢复天然椎间间隔。
19.根据权利要求16所述的植入物，其中所述生物相容性材料被加压到近似所述髓核的天然压力的压力。
20.根据权利要求16所述的植入物，其中所述生物相容性材料具有不大于约4Mpa的压缩模量。
21.根据权利要求16所述的植入物，其中所述生物相容性材料具有范围为约0.30至0.50的泊松比。
22.根据权利要求26所述的植入物，其中所述生物相容性材料是水凝胶。
23.根据权利要求22所述的植入物，其中所述水凝胶包括选自聚乙烯醇和缔合水凝胶的材料，该缔合水凝胶是聚乙烯醇和聚乙烯基吡咯烷酮的混合物。
24.根据权利要求16所述的植入物，其中所述生物相容性材料选自聚氨酯和硅酮。
25.根据权利要求16所述的植入物，所述植入物还包括预定量的通常不可压缩的材料，该材料被设置在所述被植入材料与所述栓塞之间的所述通道中。
26.根据权利要求25所述的植入物，其中所述通常不可压缩的材料选自骨接合剂、自体移植物、同种异体移植物和异种移植物。
27.根据权利要求16所述的植入物，其中所述栓塞选自骨螺钉和倒刺栓塞。
28.一种根据权利要求1所述方法植入的、用于椎间盘的可复原植入物。
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US8147553B2 (en) 2012-04-03
JP2008508045A (ja) 2008-03-21
US20060122704A1 (en) 2006-06-08
AU2005269444A1 (en) 2006-02-09
US20080312744A1 (en) 2008-12-18
EP1778134A1 (en) 2007-05-02
CA2575383A1 (en) 2006-02-09
BRPI0513834A (pt) 2008-05-20

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