CN101193608B - 互锁模块化椎间盘髓核假体 - Google Patents

互锁模块化椎间盘髓核假体 Download PDF

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CN101193608B
CN101193608B CN200680018462XA CN200680018462A CN101193608B CN 101193608 B CN101193608 B CN 101193608B CN 200680018462X A CN200680018462X A CN 200680018462XA CN 200680018462 A CN200680018462 A CN 200680018462A CN 101193608 B CN101193608 B CN 101193608B
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modular
modular segment
disc
segment
joint
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CN101193608A (zh
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杰利弗·C·菲尔特
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Vertebral Technologies Inc
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Vertebral Technologies Inc
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Abstract

本发明披露了一种利用模块化椎间盘假体以最小侵入性的方式修复受损的脊柱椎间盘髓核的方法和设备。所述模块化椎间盘假体优选地包括至少三个模块化节。在一个实施例中,每一个模块化节包括内核和外壳。模块化节选择性地彼此互锁在原位。多个模块化节形成植入的单一装置,该单一装置精密地模拟椎间盘髓核腔的几何形状。

Description

互锁模块化椎间盘髓核假体
技术领域
本发明一般涉及一种用于修复受损的椎间盘的可植入假体。更具体地,本发明涉及一种预定尺寸和形状的互锁模块化椎间盘髓核假体。 
背景技术
脊柱运动节(motion segment)由通过两个椎体结合而成的脊柱骨骼(spinal anatomy)单元组成,所述脊柱运动节包括两个椎体、插入其间的椎间盘以及所附的韧带、肌肉和平面关节(facet joint)。所述椎间盘由在椎骨的顶部和底部上的端面板、软内核、所谓髓核以及围绕髓核圆周运行的纤维环组成。在正常的椎间盘中,髓核缓冲施加的载荷,因此保护脊柱运动节的其他元件。正常的椎间盘通过相对椎端面板和纤维环(annulus fibrosus)向外凸出,而响应挤压力。所述纤维环由胶原质纤维和更少量的弹性纤维组成,这两种纤维对于抵抗拉力都有效。然而,其自身的纤维环对于经受压缩力和剪切力不是十分有效。 
随着人年龄的增长,椎间盘经常会自然地衰退。椎间盘的衰退也可能由于引起椎间盘衰退的疾病在人身上出现。脊柱的引起椎间盘衰退的疾病是造成人们的痛苦和残疾的最普通的情况之一。当椎间盘衰退时,髓核脱水。当髓核脱水时,其作为垫的能力降低。因为脱水后的髓核不再能承担载荷,所述载荷被转移到纤维环和平面关节上。纤维环和平面关节不能经受所施加的压力和扭力所增加的份额,这样它们会逐渐恶化。由于纤维环和平面关节的恶化,许多其他效应相继发生,包括间隙变窄(narrowing ofinterspace)、骨刺形成、纤维环破碎、软骨端面板断裂和恶化以及平面关节的软骨恶化。纤维环和平面关节丧失了其结构稳定性,微妙但病态的运动在椎骨之间出现。 
当环形纤维组织失去稳定性时,它易于向外膨胀并可以形成允许髓核物质挤压出的破缝。椎间盘损坏后的生成物,包括肉眼可见的碎片、微观 颗粒以及有害的生物化学物质,逐渐积累。这些损坏后的生成物刺激在椎间盘内和在椎间盘周围的敏感神经终端,这会产生下背疼痛,有时还有坐骨神经痛。受影响的个人当躯干试图进行普通的移动时会出现肌肉痉挛、下背的灵活性降低以及疼痛。 
椎间盘的衰退是不可恢复的。在一些情况下,身体将最终使运动节的关节硬化,有效地使椎间盘再稳定(re-stabilize)。甚至在出现再稳定的情况下,过程可能经过很多年而患者经常要继续经受伤残的痛苦。长于三个月的长期的痛苦经历经常使患者寻求对于他们的痛苦的外科手术解决方案。 
已经设计了多种方法,以试图稳定脊柱运动节。这些方法中的一些包括:加热环形区域以破坏神经末梢并增强纤维环;将刚性的或半刚性的支撑组件应用到运动节侧面上或椎间盘空间内;以通常的硬塑料、接合的人造装置移除和替代整个椎间盘;移除或替代髓核;以及涉及永久地将患病的椎间盘附近的椎骨融合的脊柱融合。 
直到最近,脊柱融合(spinal fusion)已经通常被认为是缓解由于椎间盘的衰退的背痛得最有效的外科治疗手段。尽管该治疗手段对于减缓背痛经常是有效的,但是在融合后的脊柱运动节中会丧失所有的椎间盘运动(discal motion)。在患病的脊柱节中的运动的丧失必然限制患者的脊柱的总体灵活性。最后,当这些节试图补偿融合的节中的运动缺失时,脊柱融合在融合的节附近的椎间盘上施加更大的应力,经常导致这些相邻的脊柱节的早期衰退。 
当前的开发集中在可以保持患病的脊柱节的一些或全部运动的治疗手段。用于稳定脊柱运动节而没有脊柱融合的缺点的这些方法之一是全椎间盘替换。全椎间盘替换是高侵入性和技术需求的工艺,其从前部或正面的途径访问椎间盘,并包括分割前部的纵向韧带,移除在椎骨和椎间盘之间的软骨端面板、大部分外纤维环和全部的内纤维环。然后,人造全椎间盘替换件被小心地置于腾出的椎间盘空间中。许多人造全椎间盘替换件当前能够由通常的硬塑料(例如超高分子量聚乙烯(“UHMWPE”))作为被插入锚定或连接到椎端面板的两个金属板之间的髓核组成。人造椎间盘的早期的开发和设计的历史的总结在Ray,“The Artificial Disc: Introduction,History and Socioeconomics,”Chpt.21,ClinicalEfficacy and Outcome in the Diagnosis of Low Back Pain,pgs.205-225,Raven Press(1992)中进行阐述。这些分层的全椎间盘替换件装置的示例,例如在美国专利Nos.4,911,718、5,458,643、5,545,229和6,533,818中示出。 
这些类型的人造整个椎间盘具有几个缺点。首先,因为人造椎间盘替换件相对大,所以它们需要相对大的手术暴露(surgical exposure),以容纳它们的插入。手术暴露程度越大,感染、出血或甚至发病的机会也越大。再者,为了植入该假体,必须移除大部分纤维环。移除大部分纤维环至少直到在人造的椎间盘愈合之前,会降低运动节的稳定性。另外,因为装置由刚性材料构成,所以如果它们要从椎间盘替换并接触局部神经或血管组织,则它们可能造成严重损伤。另一个缺点是刚性的人造椎间盘替换件不能再现自然的椎间盘结构。 
全椎间盘替换件的替代品是髓核替换件。类似人造椎间盘假体,这些髓核替换件也是惰性的、非刚性的、非生物的替换件。用于植入髓核替换件的工艺比对于全椎间盘替换件的工艺侵入性小,并通常包括以具有韧性并提供模仿自然的椎间盘髓核的垫子的假体移除仅仅髓核和髓核的替换件。用于髓核替代物的植入物的示例包括:美国专利Nos.4,772,287、4,904,260、5,192,326、5,919,236和6,726,721。 
髓核替换件用于更近似地模仿自然的椎间盘结构。为了那样的目的,一些髓核替换件采用水凝胶,这是因为它们的吸水性能够使这些替换件在原地膨胀以允许更完全地填充被腾出的髓核腔。然而,通常存在一种平衡,其中水凝胶获得的越多,末端产品可以提供的结构支撑越少。结果,许多水凝胶髓核椎间盘已经通常采纳使用一些封套或织物的形式以约束水凝胶材料。例如,在美国专利Nos.4,772,287和4,904,260所述的植入物包括装入塑料织物壳体中的水凝胶块。在美国专利No.5,192,326中所述的植入物由织物壳体封住的水凝胶珠组成。没有封套或其他形式的约束,水凝胶因为水凝胶的滑移属性而容易移动。不幸地,封套(jacket)或织物壳体将经受长时期的磨损问题,所述磨损问题可以造成封套或罩约束水凝胶的能力的失效,并因此水凝胶可能经受偏移。 
涉及髓核替换的另一方法涉及植入球状物或其他容器到髓核中,然后球状物或其他容器填充有可以强化保持在原位的生物相容的材料。这种使髓核替换件保持在原位的方法的示例包括美国专利No.6443988和No.7001431。该方法的一个问题是化学硬化处理是放热的并且能够产生相当大的热量,这么多热量会引起组织损伤。另外,也存在下面的可能性:球状物在膨胀期间可能会破裂,从而导致材料泄漏到椎间盘空间内并围绕组织,这会引起不希望的并发症。 
用于髓核替换的另外的技术涉及植入多个单独的支撑件,例如小球,一次一个地放置到空出的髓核腔内直到该腔是满的。该方法的示例包括美国专利No.5,702,454和No.5,755,797。因此单独支撑件或小球中的每一个相对较小,所以存在一个或更多单独支撑件或小球被挤出空出的椎间盘髓核腔的可能性。从结构的角度看,该技术在产生一致和可复制的结果上存在限制,因为多个小球或支撑件的位置和相互作用是不受控制的,且小球或支撑件在植入过程中和植入之后可能移位。 
因此,存在对下面一种髓核假体的需要,该髓核假体可以使用最小侵入性的过程被插入并且模拟天然椎间盘的特性。 
发明内容
本发明提出了使用模块化椎间盘髓核假体以最小的侵入性方式修复受损的脊柱椎间盘髓核的方法和设备。该模块化椎间盘假体优选地包括至少三个模块化节。在一个实施例中,每一个模块化节包括内核和外壳。所述模块化节彼此选择性地可互锁在原位。该模块化节形成植入的单一装置,该单一装置很精密地模拟椎间盘髓核腔的几何形状。 
在一个实施例中,一种适于植入空出的椎间盘髓核空间中的模块化椎间盘假体包括:至少三个模块化节,每一个模块化节具有由相对的侧面、近端、和远端限定的宽度。所述模块化节彼此选择性地互锁,从而所述假体具有延伸的构造和植入的构造。在延伸的构造中,外部模块化节的一侧的近端可操作地靠近中间模块化节的侧面之一的远端定位,且另一外模块化节的一侧面的远端可操作地靠近中间模块化节的侧面的另一个的近端定位。在植入的构造中,模块化节以大体上并排关系定位在空出的椎间盘 髓核空间内,且每一个模块化节的近端彼此邻近、每一个模块化节的远端彼此邻近,从而限定具有大体上连续周边的单一主体,在所述单一主体中多个模块化节的整个宽度大体上对应于空出的椎间盘髓核空间的宽度。 
优选地,每一个模块化节包括外壳和内核。模块化节的外壳优选由聚合体材料组成。在一个实施例中,模块化节的内核由聚乙烯醇(PVA)组成,所述内核可以插入模制到聚合体外壳内。这使得模块化椎间盘假体的压缩模量软化,从而允许装置更加精密地模拟天然椎间盘髓核的特性。另外,一旦放入到体内,PVA将使得假体膨胀一个小的量,从而允许装置更加充分地充填椎间盘髓核空间。 
本发明的另一方面提供了一种将模块化椎间盘假体植入到空出椎间盘髓核空间内的方法。所述方法是最小侵入性的,因为模块化椎间盘假体被逐渐植入,因此装置可以通过比装置的植入的构造的尺寸小得多的annulotomy植入。为了植入模块化椎间盘假体,将第一模块化节引入到病人的椎间盘空间内并部分放置到椎间盘髓核空间内。然后将第二模块化节连接到第一模块化节上。当第一模块化节大部分插入到椎间盘髓核空间内时,第二模块化节滑动而局部进入到椎间盘空间内,且第三模块化节连接到第二模块化节上。此时第一模块化节完全插入。然后第二模块化节延伸到第一模块化节旁边的位置,并被锁定在椎间盘髓核空间内适当的位置。最后,第三模块化节完全插入到椎间盘髓核空间内并与另外的模块化节锁定在适当的位置。模块化椎间盘假体的模块化节的最后植入的并排构造尺寸和形状被调整以模拟天然的椎间盘髓核。将认识到,可以存在多于三个的模块化节,以及模块化节可以在手术过程中或手术前被彼此连接以形成如所述的膨胀构造。 
本发明的另一方面提供了一种用于插入模块化椎间盘髓核假体的插入工具。该插入工具具有远端和近端,所述远端具有选择性接合和释放一个或更多模块化节的机构,所述近端具有致动所述接合和释放机构的装置。插入工具的远端也可以包括将正被插入的模块化节与已经位于椎间盘空间内的模块化节对准的装置。 
附图说明
通过下面结合附图详细描述本发明的各种实施例,将会更充分地理解本发明。 
图1是根据本发明优选实施例的模块化椎间盘假体的透视图; 
图2是根据本发明优选实施例的模块化椎间盘假体的俯视图; 
图3A是根据本发明优选实施例的第一模块化节的透视图; 
图3B是根据本发明优选实施例的第一模块化节的俯视图; 
图4是根据本发明优选实施例的第二模块化节的透视图; 
图5是根据本发明优选实施例的第三模块化节的透视图; 
图6是根据本发明优选实施例的第四模块化节的透视图; 
图7是根据本发明优选实施例的模块化椎间盘假体的局部视图; 
图8是根据本发明优选实施例的模块化椎间盘假体的俯视图; 
图9是根据本发明可选实施例的模块化椎间盘假体的透视图;和 
图10是根据本发明可选实施例的模块化椎间盘假体的透视图。 
具体实施方式
参照图1和2,可以看到根据本发明优选实施例的模块化椎间盘假体100。在此实施例中,模块化椎间盘假体100包括第一互锁模块化节102、第二互锁模块化节104、第三互锁模块化节106、第四互锁模块化节108。本领域普通技术人员将认识到在可选实施例中,只要存在至少三个模块化节,该优选实施例可以被容易地修改成包括更多或更少的模块化节。 
现在参照图3A-3B,图中显示了根据本发明优选实施例的模块化椎间盘假体100的第一模块化节102。第一模块化节102优选地由外壳102a和内核102b组成。外壳102a进一步包括用于与邻近模块化节互锁的锁定滑动件110。 
图4显示了根据本发明优选实施例的第二模块化节104。第二模块化节104优选地由外壳104a和内核104b组成。外壳104a进一步包括邻近模块化节的锁定滑动件插入其内的第一狭槽112和第二狭槽114。 
参照图5,图中显示了模块化椎间盘假体100的第三模块化节106。第三模块化节106优选地由外壳106a和内核106b组成。外壳106a进一步包括用于插入到邻近模块化节的狭槽内的第一锁定滑动件116和第二锁 定滑动件118。 
图6显示了根据本发明优选实施例的模块化椎间盘假体100的第四模块化节108。第四模块化节102优选地由外壳108a和内核108b组成。外壳108a进一步包括用于连接到邻近模块化节的狭槽120。 
如从上面的描述和图中可以看见的,每一个模块化节102、104、106和108是唯一的。两个最外的模块化节102和108具有仅仅限定在内部面对侧上的互锁结构,而中间的模块化节104和106具有限定在每一个模块的两个宽度侧上的互锁结构。每一个模块的唯一的构造保证模块化节的插入顺序不会混淆,且使用适当数量的模块化节。该四个部分的设计被消毒封装并易于在外科手术场所组装。在可选的实施例中,模块化节可以是一致的设计(例如,狭槽在一侧上且锁定滑动件在另一侧上),以允许外科医生在特定过程中自由增加或减少模块化节的总数量或选择不同宽度的中间模块化节以改变模块化椎间盘假体的尺寸,从而更好地适应椎间盘髓核空间。 
如可以在图7中看见的,模块化节102、104、106和108能够将滑动锁定件110、116、118插入到狭槽112、114、120中而彼此互锁。在优选的实施例中,锁定滑动件110、116、118和狭槽112、114、120具有舌状物在槽内的(tongue-in-groove)设计。互锁还可以利用脊、楔形榫接、棘轮与掣爪或其他适合的机械接合方法实现。互锁也可以通过材料接合(material interface)例如通过形成吸湿性的并且在原位膨胀的材料的互锁接合或通过在接触面之间形成化学键,而补充或完全实现。 
互锁可以通过提供锁定元件而加强,例如沿锁定滑动件模制的倒钩以及在狭槽边缘上模制的对应的锁定脊。在本发明的实施例中,椎间盘髓核装置包括至少一个双向锁定元件以防止部件向前和/或向后运动。在另一实施例中,椎间盘髓核假体可以包括至少两个单向锁定元件。其中,锁定元件中的至少一个防止部件向前运动,且其他单向锁定元件中的至少一个防止部件向后运动。在模块化节锁定在一起之后希望将它们分开的情况下可以设置棘轮释放工具或其他相似工具。本领域普通技术人员将认识到模块化节可以通过各种其他装置互锁。另外,模块化节也设置有块规(endblock)以保证模块化节之间齐平对准。 
模块化节优选地由聚合体材料制成。在优选的实施例中,模块化节102、104、106和108的外壳102a、104a、106a、108a由聚亚安酯组成。在优选的实施例中,锁定滑动件110、116、118和狭槽112、114、120由硬度比外壳102a、104a、106a、108a更高的聚亚安酯制成,以进一步加强相邻部分之间的互锁。在此实施例中两种不同硬度的聚亚安酯可以被共聚合以在它们之间形成化学键或者结合。在又一可选实施例中,外壳可以由其他任何适合的弹性体生物材料制成。 
在优选的实施例中,模块化节102、104、106和108的内核102b、104b、106b、108b由聚乙烯醇(PVA)组成。PVA可以插入模制到聚亚安酯壳内。PVA比聚亚安酯容纳多得多的水,这具有两个优点。首先,这使得模块化椎间盘假体100的压缩模量软化,从而允许装置更加精密地模拟天然椎间盘髓核的特性。第二,一旦在身体内部,它将使得假体100膨胀一个小的量,从而允许装置更加充分地充填椎间盘髓核空间。本领域普通技术人员将理解如何选择具有适当吸湿特性的PVA以调整假体所获得的压缩模量到生理上能接受的值。在可选实施例中,内核可以由任何其他适合的吸湿材料组成。 
在优选的实施例中,模块化椎间盘髓核假体响应于30-300磅的正常力可变形。因此此可变形性,假体在椎间盘的端板上产生了生理上适当的量的载荷。结果,与很多更具刚性的椎间盘髓核替换植入件的情况一样,端板将不会随着时间而过度变形,并且最终符合植入件的轮廓。 
模块化椎间盘髓核假体可以通过进入管引入,所述进入管局部插入到椎间盘髓核空间内。进入管至少3英寸长,优选大约6英寸长。应该注意的是,尽管模块化椎间盘假体的插入结合优选的四节实施例进行描述,具有其他任何数量节的实施例也可以相似的方式插入。 
可以使用插入工具以帮助插入和定位模块化假体。这种工具具有远端和近端,该远端选择性地接合和释放模块化节,该近端容纳用于启动接合和释放机构的装置。插入工具的接合方法可以包括完全或局部的套管,该套管与模块化节的外表面过盈配合;具有尖端的杆,所述尖端可以膨胀或者扩张以在每一个模块化节内的对应的腔内互锁;两根或更多杆,该杆具有有形状或有角度的尖端,该尖端可以插入和对置(opposed)到每一个 模块化节内对应的腔内,或其他本领域普通技术人员容易想到的相似手段。插入工具的远端也可以具有线、杆、轨道或其他装置以使得正被插入的模块化节与已经至少局部定位在椎间盘空间内的模块化节对准。该插入工具可以由塑料、金属、陶瓷等的任何组合而制成。 
当将进入管插入到椎间盘髓核空间内时,如图1和2中所示,第一模块化节102使用第一插入工具被局部插入到椎间盘空间内。第二模块化节104的远端然后使用第二插入工具通过滑动狭槽112到锁定滑动件110上而连接到第一模块化节102的近端。当第一模块化节102优选地大致80%插入到椎间盘髓核空间内时,第二模块化节104沿第一模块化节102的锁定滑动件110局部移位到椎间盘髓核空间内,且第三模块化节106的远端利用第三插入工具通过滑动锁定滑动件116到狭槽114内连接到第二模块化节104的近端。第一模块化节102在此时完全插入并从第一插入工具释放。第二模块化节104然后延伸到第一模块化节102旁边的位置,并被锁定在椎间盘髓核空间内适当的位置,并从第二插入工具释放。第三模块化节106现在局部处于椎间盘髓核空间内,并且利用第四插入工具通过将狭槽120滑动到锁定滑动件118上,第四模块化节108的远端连接到第三模块化节106的近端。第三模块化节106然后完全插入到椎间盘髓核空间内并锁定在位,并从第三插入工具释放。最后,第四模块化节108完全插入到椎间盘髓核空间内,用其他模块化节锁定在位,并从第四插入工具释放。此实施例的模块化椎间盘假体100的最终锁定的构造在图8中示出。 
在另一实施例中,第一模块化节由第一插入工具接合并且完全插入到髓核腔内。然后第二模块化节使用第二插入工具连接到第一模块化节并完全插入到髓核腔内。随后的模块化节然后以相同的方式连接直到模块化假体被完全组装。可选地,与本发明任一实施例一起使用的插入工具可以设计成同时接合两个或更多模块化节以避免需要多个插入工具来执行植入过程。 
可选地,模块化假体可以使用前侧方法被植入。前侧方法允许使用更大的插入开口同时仍然保持最小的侵入性。 
该假体由预制的构件组成,所述预制的构件由外科医生直接控制直到装置完全形成,由此,当插入构件时,存在构件脱离的很小的可能性。在 插入过程中控制构件的能力是本装置相对采用单独的支撑件(例如小球,其一旦插入就不受外科医生的控制并且可以在空出的椎间盘空间内四处移动)的一个优点。因为本发明的构件在外科医生的直接控制之下,所以外科医生可以更加精确地将构件放置在空出的椎间盘空间内,且较少会出现构件在装置的插入过程中移动到不希望的位置。 
此外,相较于其它种类的最小侵入性的植入件,预先确定模块化椎间盘假体的尺寸的能力也允许髓核腔被更加完全地填充,并且该能力也提供了对植入件的应力响应的一致性的更大程度的控制。因为植入件的应力响应可以得到控制,即使在机能不全的后壁的情况下,假体也应该保持稳定。调整假体的尺寸的能力以及完全充填髓核腔的能力也防止了对于一些水凝胶块植入件所可能发生的、在装置完全植入后假体从髓核腔移出的情况。 
现在参照图9和10,图中显示了模块化椎间盘假体200的可选实施例。模块化椎间盘假体200是三件的植入件,具有系绳216、218来帮助对准装置。模块化椎间盘假体200包括第一模块化节202,具有形成在其内的狭槽208;第二模块部分204,具有形成在其内的第一锁定滑动件210和第二锁定滑动件212;和第三模块化节206,具有狭槽214。模块化椎间盘假体200进一步包括系绳216、218,该系绳(tether)216、218穿过在第一模块化节202和第三模块化节206中的孔220、222。本领域普通技术人员将认识到,系绳216、218的数量和位置可以变化且系绳可以与具有不同数量的模块化节的模块化椎间盘假体一起使用。 
在可选实施例中,模块化椎间盘假体的外壳被修改为提供药物的洗脱(elution)。这种药物可以包括镇痛剂、抗生素、抗肿瘤药或例如骨生长剂的生物骨骼剂(bioosteologics)。尽管运动功能预保留一般是髓核替换中的主要目的,但是在某些情况下,也希望使用一些骨融合。这样的情况可以包括在脊柱颈段的髓核替换中。 
模块化椎间盘假体的固态聚合体外壳可以比一些水凝胶材料提供更好和更可控制的洗脱率。在可选的实施例中,模块化椎间盘髓核假体对于每种聚合体材料可以包括不同的洗脱率(elution rate)。这将允许对于不同的药物改变洗脱率。 
本领域普通技术人员在阅读本说明书时可以容易对所披露的设备和方法做出各种修改。上述并不试图限制本发明的保护范围,该保护范围仅由权利要求限定。 

Claims (9)

1.一种模块化椎间盘假体,适于植入空出的椎间盘髓核空间中,所述假体包括:
至少三个模块化节,每一个模块化节具有由相对的侧面、近端部分、和远端部分限定的宽度,所述模块化节彼此选择性地互锁,从而所述假体具有:
延伸的构造,其中外部模块化节的一侧的近端部分可操作地靠近中间模块化节的侧面之一的远端部分定位,且另一外部模块化节的一侧面的远端部分可操作地靠近中间模块化节的侧面的另一个的近端部分定位,和
植入的构造,其中模块化节以大体上并排关系定位在空出的椎间盘髓核空间内,且每一个模块化节的近端部分彼此邻近、每一个模块化节的远端部分彼此邻近,从而限定具有大体上连续周边的单一主体,在所述单一主体中多个模块化节的整个宽度大体上对应于空出的椎间盘髓核空间的宽度;
其中每一个模块化节包括外壳和内核;
其中所述外壳由第一部分和第二部分组成,所述第一部分由低硬度聚合体组成,而所述第二部分由较高硬度的聚合体组成。
2.根据权利要求1所述的模块化椎间盘假体,进一步包括至少两个中间模块化节,其中所述中间模块化节之一的一个侧面的近端部分可操作地邻近所述中间模块化节中的另一个的一个侧面的远端部分。
3.根据权利要求1所述的模块化椎间盘假体,其中每一个模块化节包括内部部分和外部部分,所述内部部分在至少一侧上包括与在邻近模块化节的至少一侧上的对应的结构选择性互锁的结构,且所述外部部分大体上围绕内部部分,除了具有与在邻近模块化节的至少一侧上的对应的结构选择性互锁的结构的侧面之外。
4.根据权利要求3所述的模块化椎间盘假体,其中所述与在邻近模块化节的至少一侧上的对应的结构选择性互锁的结构对于所有模块化节是相似的。
5.根据权利要求3所述的模块化椎间盘假体,其中所述与在邻近模块化节的至少一侧上的对应的结构选择性互锁的结构包括在一侧上的棘轮和在相邻的模块化节上的对应的棘爪。
6.根据权利要求3所述的模块化椎间盘假体,其中所述外部部分的至少一层进一步包括至少一种药物,该药物被可操作地携带以在假体植入之后该药物由外部部分洗脱。
7.根据权利要求1所述的模块化椎间盘假体,其中所述模块化节的宽度大体上相似并且限定假体在膨胀位置上的宽度,假体在膨胀位置上的宽度确定用于将假体插入到空出的椎间盘髓核空间内的开口的最小宽度。
8.根据权利要求7所述的模块化椎间盘假体,其中用于插入假体的所述开口的宽度小于大约1cm。
9.根据权利要求1所述的模块化椎间盘假体,进一步包括系绳,所述系绳穿过在多个模块化节的至少之一上的孔口,以帮助在植入过程中对准模块化椎间盘假体。
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US11/372,477 US7591853B2 (en) 2005-03-09 2006-03-09 Rail-based modular disc nucleus prosthesis
US11/372,357 US7267690B2 (en) 2005-03-09 2006-03-09 Interlocked modular disc nucleus prosthesis
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