CN1859883A - 用于增强或修复椎间盘的同种异体/异种植入物及方法 - Google Patents

用于增强或修复椎间盘的同种异体/异种植入物及方法 Download PDF

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Publication number
CN1859883A
CN1859883A CNA2004800279796A CN200480027979A CN1859883A CN 1859883 A CN1859883 A CN 1859883A CN A2004800279796 A CNA2004800279796 A CN A2004800279796A CN 200480027979 A CN200480027979 A CN 200480027979A CN 1859883 A CN1859883 A CN 1859883A
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Prior art keywords
implant
allogeneic
xenogenesis
intervertebral disc
disk ring
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CN1859883B (zh
Inventor
H·H·德留
W·F·麦克凯
J·塞尔布赛克
M·C·舍曼
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Warsaw Orthopedic Inc
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SDGI Holdings Inc
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Abstract

用于提供椎间盘核植入物和/或环面塞的同种异体或异种材料。该同种异体或异种材料包括天然盘环材料，其附着有一部分前纵韧带。组织可“原样”使用而不需要其它芯或包覆，或它可与其它物质联合使用。材料可卷曲、折叠、层压和/或缝合，钉合或胶粘，提供天然生物材料的固体塞。植入物可以是直径小于水合材料直径的脱水、基本上杆形的段，脱水杆的一个或多个末端具有直径减小的部分，优选是尖端。

Description

用于增强或修复椎间盘的同种异体/异种植入物及方法
发明背景
本发明一般涉及用于重建椎间盘的植入物和方法，更具体地涉及使用同种异体或异种组织增强或修复椎间盘。
发明背景
已知椎间盘易受损失和退化。例如，常见椎间盘脱出，通常在正常磨损或异常劳损时发生，使椎间盘破裂。退化的椎间盘病通常是由正常老化进程引起的，其中，组织逐渐失去其天然水份和弹性，使退化的椎间盘萎缩且可能破裂。
常常通过替代或增强存在的盘材料来处理椎间盘损伤和退化。目前的椎间盘植入物倾向于采用合成材料，尤其是水凝胶，来增强或替代原来的椎间盘。这些合成材料一般涂覆有变形织物，其粗糙表面可加速包封的水凝胶或椎体骨终板的磨损。这种磨损可产生磨损颗粒，导致不良生物反应，例如椎体终板骨中的骨质溶解和接着植入物的沉陷。
例如，关于具有聚乙烯网套的假体核替代装置的报道表明，这些装置可沉陷入椎体终板。沉陷也是因为网套与硬质水凝胶芯的刚性符合。这种与椎骨的模量失配，与上述其它设计特征接合，以促使植入物沉陷。
为避免与合成材料相关的问题，可使用天然材料来修复或增强椎间盘。例如，美国专利申请序列号10/245,955(纳入本文作为参考)和美国专利申请序列号09/411,547(也被纳入本文作为参考)都公开了使用天然基于胶原的材料来修复和/或增强椎间盘。
使用天然基于胶原的材料来修复和/或增强椎间盘尤其适用于提供具有天然组织特征仍保持固定在原位的环面塞和/或核植入物。
由上述可见，需要由天然基于胶原的材料，尤其是同种异体或异种材料构成的改进的环面塞和/或核植入物。
发明概述
本发明一方面使用同种异体或异种盘环材料提供椎间盘核植入物和/或环面塞。同种异体或异种盘环材料可以是完整的环面，或是环面的一段如前部。环面材料优选不含，或至少基本上不含盘核材料和盘终板材料。在优选的实施方式中，植入物中可包含一部分前纵韧带。
组织可“原样”使用而不需要其它芯或包覆，或它可与其它物质联合使用。前纵韧带接可包围盘环材料，保护和支撑植入物，以改善植入物的强度和稳定性。材料可卷曲、折叠、脱水、压缩、层压、缝合、钉合、胶粘等，形成具有所需植入物尺寸和几何形状的植入物。
在一个优选的实施方式中，将一段同种异体或异种前环面拉直、压缩、脱水，形成具有直径比未压缩材料的直径小的杆形植入物。优选将植入物的至少一端削尖，以便将植入物推入通过待修复的盘中小洞。植入后植入物再水合，提供所需的支撑，以防止植入物从修复的盘中排出。
本发明的一个目的是提供由更紧密配合所需增强、修复或替代组织的材料构成的椎间盘植入物。从下面优选实施方式的描述，本发明的其它特征和优点将显而易见。
附图简要说明
图1是两相邻椎骨间椎间盘的侧视图，附着有前纵韧带。
图2是根据本发明一个实施方式的天然盘材料的侧视图，一块前纵韧带附着且向盘的上方和下方延伸。
图3是根据本发明一个实施方式的天然盘材料的侧视图，一块前纵韧带附着且仅从盘的一个方向延伸。
图4是根据本发明一个实施方式的天然盘材料的侧视图，附着有前纵韧带。
图5是在前纵韧带折叠和固定于植入物周围之前，根据本发明一个实施方式的天然盘植入物的侧视图。
图6是图5的天然盘植入物的平面图。
图7是在前纵韧带折叠和固定于植入物周围之后，图5的天然盘植入物的平面图。
图8是在前纵韧带折叠和固定于植入物周围之后，图5的天然盘植入物的侧视图。
图9是在前纵韧带折叠和固定于植入物周围之前，根据本发明一个实施方式的天然盘植入物的侧视图。
图10是图9的天然盘植入物的平面图。
图11是在前纵韧带折叠和固定于植入物周围之后，图9的天然盘植入物的平面图。
图12是在前纵韧带折叠和固定于植入物周围之后，图9的天然盘植入物的侧视图。
图13是在前纵韧带折叠和固定于植入物周围之前，根据本发明实施方式的一对天然盘植入物的侧视图。
图14是在前纵韧带折叠和固定于植入物周围之后，图13的天然盘植入物的侧视图。
图15是在前纵韧带折叠和固定于植入物周围之后，图13的天然盘植入物的平面图。
图16是根据本发明一个实施方式的天然盘植入物的侧视图。
图17是图16的天然盘植入物的平面图。
图18是在前纵韧带包裹和固定于植入物周围之后，图16的植入物的侧视图。
图19是在前纵韧带包裹和固定于植入物周围之后，图16的植入物的平面图。
图20是根据本发明一个实施方式的天然盘植入物的侧视图。
图21是图20天然盘植入物的平面图。
图22是在前纵韧带折叠和固定于植入物周围之后，图20的天然盘植入物的平面图。
图23是在前纵韧带折叠和固定于植入物周围之后，图20的天然盘植入物的侧视图。
图24是根据本发明一个实施方式的天然盘植入物的平面图。
图25是植入物已备用后，根据本发明一个实施方式的天然盘植入物的平面图。
图26植入物已备用后，是根据本发明一个实施方式的天然盘植入物的平面图。
图27植入物已备用后，是根据本发明一个实施方式的天然盘植入物的平面图。
图28是植入物已备用后，根据本发明一个实施方式的天然盘植入物的平面图。
图29是植入物已备用，根据本发明一个实施方式的天然盘植入物的平面图。
图30是图29的植入物的侧视图。
图31是根据一个优选的实施方式，本发明环面塞的侧视图。
图32图31的环面塞的平面图。
图33根据一个优选的实施方式，本发明环面塞的平面图。
图34是环面塞已备用后，图33的环面塞的平面图。
图35是根据一个优选的实施方式，本发明环面塞的侧视图。
图36是图35环面塞的平面图。
图37是根据一个本发明实施方式，环面塞已备用后，图35的环面塞的平面图。
图38是根据一个本发明实施方式，环面塞已备用后，图35的环面塞的侧视图。
图39是根据另一个本发明实施方式，环面塞已备用后，图35的环面塞的平面图。
图40是根据另一个本发明实施方式，环面塞已备用后，图35的环面塞的侧视图。
图41是根据一个优选的实施方式，本发明环面塞的平面图。
图42是图41的环面塞的平面图。
图43是根据一个优选的本发明实施方式，环面塞已备用后，图41的环面塞的平面图。
图44是根据一个优选的本发明实施方式，环面塞已备用后，图41的环面塞的侧视图。
图45是图41的环面塞的侧视图。
图46是根据另一个本发明实施方式，环面塞已备用后，图45的环面塞的平面图。
图47是根据另一个本发明实施方式，环面塞已备用后，图41的环面塞的侧视图。
图48A-B显示了本发明脊柱植入物，图48A显示压缩和脱水之前的完整盘环，图48B显示压缩和脱水之前的一段盘环。
图49显示了用于压缩本发明一个实施方式的脊柱植入物的模具。
图50显示了用于压缩本发明一个实施方式的脊柱植入物的模具。
图51显示了根据本发明一个实施方式的压缩、脱水的脊柱植入物。
图52显示了植入物的一端削尖后，图51的压缩、脱水的脊柱植入物图51。
图53显示了用于压缩本发明一个实施方式的脊柱植入物的可选模具。
图54-57显示了使用本发明脊柱植入物的方法。
图54显示了刚好在植入患者之前的本发明一个实施方式的脊柱植入物。
图55显示了进入待修复的盘时图54的脊柱植入物。
图56显示了植入盘核隙后图54的脊柱植入物。
图57显示了在盘核隙内再水化后图54的脊柱植入物。
图58显示了在收集异种盘环材料之前的猪盘。
图59显示了切成两半后的图58猪盘。
图60显示了从图58的盘取出的异种环面材料。
图61A-61C显示了卷曲前、卷曲时和卷曲后图60的异种环面材料。
图62显示了植入备用的异种盘环材料以增强盘核。
图63A-63B显示了插入盘隙的图62的异种盘环材料。
图64显示了包含图62的异种环面材料的切开的盘。
优选实施方式的描述
为促进对本发明原理的理解，现在将参考优选实施方式并将用具体语言描述这些实施方式。但是，应理解这不是为了限制本发明的范围，涵盖了本文所述方法和/或装置的改变和进一步改进，以及本发明原理的进一步应用，就如本发明相关领域技术人员通常所理解的那样。
如本文所述，本发明一方面提供用于增强或替代椎间盘核的材料和方法。本发明另一方面提供用于修复或堵塞椎间盘环的材料和方法。为了说明，将盘核植入物和盘环植入物称为椎间盘植入物。
本发明椎间盘植入物包括同种异体或异种盘环材料。同种异体或异种盘环材料基本上不含盘核材料和盘终板材料。如下进一步所述，盘环材料可以是完整的盘环，或仅仅是盘环的一部分或一段。仅使用一段环面时，其可以是来自环面前部的一段，或是来自环面侧部或后部的一部分。
在一些实施方式中，本发明植入物包含同种异体或异种盘环材料及其它材料。例如，包含同种异体或异种盘环材料植入物可含有其它治疗剂和/或物质以改进性能或促进植入。在其它实施方式中，植入物由，或基本上由同种异体或异种盘环材料构成。
在一些实施方式中，植入物中也可使用同种异体或异种韧带材料，尤其是前纵韧带材料。韧带材料是优选的材料，它天然连接于用于植入物的环面。
在包含同种异体或异种前纵韧带材料的实施方式中，前纵韧带可包括从侧面看时在环面上方和/或下方延伸的部分，使得韧带材料的长度有助于形成植入物。在其它实施方式中，前纵韧带限制在邻近环面的部分，因而不向环面上方或下方延伸。当使用较长的韧带部分时，该材料的长度优选约为0.5-2.5cm，虽然可使用更短或更长的前纵韧带。例如，在一些实施方式中，前纵韧带足够地长以完全包裹同种异体/异种盘(或其块)，保护和稳定植入物。在其它实施方式中，前纵韧带足够地长以完全包裹两个或多个同种异体/异种盘(或其块)，以保护和稳定所形成的植入物。
为说明本发明，术语同种异体和异种是相对于待植入组织的宿主而言的。因此，同种异体组织指相对于需要植入的患者，遗传学上不同但来自相同种来源的组织。类似地，异种组织指来自与需要植入的患者不同种来源的组织。在一些实施方式中，本发明提供和使用具有同种异体或异种前纵韧带的同种异体或异种盘材料。在这些实施方式中，盘材料和前纵韧带可与宿主同种异体/异种，如果它们来自相同的遗传来源，则相互同源。
为补偿同种异体或异种组织，可将附着有前纵韧带的完整的盘取出。优选地，除去盘核和任何盘终板材料，使得仅保留环面和附着的前纵韧带。在其它实施方式中，仅补偿盘环材料。
植入前，材料可保持水合，或是脱水或半水合的。如果需要在植入患者之前或期间形成所需形状的植入物，则尤其优选脱水组织。在这种情况下，通常在植入后使脱水组织再水合，通过自发地从环境吸收液体进入放置位置，或通过在手术期间或手术后将再水合液体注入植入物中。再水化后，植入物保留其脱水形状，或可改变形状以填塞或配合它已植入的间隙。
如上所述，可整体使用补偿的同种异体或异种组织，或将其切成块，提供具有适当尺寸的组织块以形成所需植入物。例如，同种异体或异种盘环材料可用作完整的材料“环”(处理或没有处理成形)，或将其切割或拉直，形成同种异体或异种盘环材料的长“管”。或者，可将同种异体或异种盘环材料切割成比完整环面小的段，处理或没有处理成形。当仅使用一段环面时，优选包含前环材料。
无论使用完整组织还是块状组织，组织可压缩、折叠、卷曲或处理成所需几何形状。而且，组织可缝合、钉合、胶粘等，以保持所需的植入物几何构型。(为说明本文，术语“缝合”指将卷曲或折叠的植入物或其块固定为特定几何构型的任何方法，包括使用缝合线、缝线、肘钉、胶、粘结剂和其它本领域已知有效的保存和固定组织的其它方法)。一些具体优选的几何构型的例子如下图所示。
现在参考附图，图1是在两相邻椎骨12和13之间的椎间盘10的侧视图，附着有前纵韧带11。盘10包括环面部分14和盘核15。在本发明优选的实施方式中，用附着的前纵韧带11补偿盘10，用于制备核植入物和/或环面塞。
图2是根据本发明一个实施方式的天然盘材料20的侧视图，一块前纵韧带21附着且向盘的上方和下方延伸。盘材料20包括盘核22和盘环23。虽然在图示中前纵韧带21块的长度不足以完全包裹盘20以保护和稳定植入物，但图仅是示例性的目的，而不表示完全包裹盘所需的前纵韧带21的适当长度。
图3是根据本发明一个实施方式的天然盘材料30的侧视图，一块前纵韧带31附着且仅从盘的一个方向延伸。盘材料30包括盘核32和盘环33。在这里，图仅仅是示例性的目的，且而不表示前纵韧带21的长度适合完全包裹盘20以保护和稳定植入物。
图4是根据本发明一个实施方式的天然盘材料40的平面图，附着有前纵韧带41。盘材料40包括盘核42和盘环43。
图5是根据本发明一个实施方式，同种异体/异种盘植入物50的侧视图。图6是同一盘植入物50的平面图。在所示实施方式中，植入物50基本上由同种异体/异种盘环材料52的块构成，附着有向上和向下延伸的前纵韧带51的块。在图5和6中，显示了在韧带51包裹和固定于植入物周围形成所需的植入物几何构型之前，前纵韧带51和盘环材料52。在该实施方式中，块52不包括整个盘环，而是仅包括一块(或“一段”)环面。
图7是在前纵韧带51包裹和固定于植入物周围形成所需的植入物几何构型之后，图5的同种异体/异种盘植入物50的平面图。图8是图7的包裹和固定的盘植入物的侧视图。由图可见，图5-8的同种异体/异种盘植入物利用前纵韧带51，使韧带包裹围绕环面材料52，形成更强、更稳定的植入物。任选地，通过用缝线54精细缝合韧带材料，韧带51固定在环面材料52周围。在最优选的实施方式中，植入物50为立方体形状55，韧带51在立方体六个面中的四个上部分地或基本上覆盖环面材料52。
图9是根据本发明一个实施方式，同种异体/异种盘植入物90的侧视图。图10是同一盘植入物90的平面图。在所示实施方式中，植入物90基本上由完整的同种异体/异种盘环92构成，附着有向上和向下延伸的前纵韧带91的块。盘核隙93位于盘环92的中央，由于去除了盘核，在所示实施方式中是空的。在图9和10中，显示了在韧带91包裹和固定于植入物周围形成所需的植入物几何构型之前，前纵韧带91和盘环材料92。
图11是同种异体/异种盘植入物110的平面图，通过使前纵韧带91包裹环面92并使自由端固定在一起形成所需的植入物几何构型。图12是图11的包裹和固定的盘植入物的侧视图。如图所示，图9-12的同种异体/异种盘植入物利用前纵韧带91，使韧带包裹围绕环面材料92，形成更强、更坚实的植入物。如图所示，在所示实施方式中，紧密压实盘核隙93，进一步加固植入物，使其更加坚实和稳定。
如图5-8的植入物那样，通过用缝线94精细缝合韧带材料，韧带91可固定在环面材料92周围。虽然在本实施方式中，使用了完整的同种异体/异种盘环，韧带材料保持环面压实的闭合，以消除中央可能存在的开口。在最优选的实施方式中，植入物90具有如图11所示的肾形，韧带91在肾形中段附近部分地或基本上覆盖环面材料92。
图13是根据本发明实施方式，一对同种异体/异种植入物块131和132的侧视图。各个植入物块分别包含同种异体/异种盘环133和134，以及前纵韧带135和136的块。韧带材料优选仅从环面的一个方向延伸，如图所示。
图14和15显示了将植入物块131和132缝合在一起之后形成的同种异体/异种植入物140。一个缝线141用于连接韧带135和136的块下部的块131和132。另一缝线142用于固定韧带块135和136的两端，将它们拉伸在环面块133和134上。所得植入物140的厚度是如图7和11所示单层植入物厚度的两倍。在一个类似于图11所示实施方式的实施方式中，使用一对完整的同种异体/异种环面，将前纵韧带缝合到一起以使两块包在一起。
图16-18显示了本发明另一个实施方式，图16显示根据本发明一个实施方式，同种异体/异种盘植入物160的侧视图。图17是同一个盘植入物160的平面图。在所示实施方式中，植入物160基本上由一段同种异体/异种盘环材料162构成，前纵韧带161的块附着且仅从环面的一个方向延伸。在图16和17中，显示了在韧带161包裹和固定于植入物周围形成所需的植入物几何构型之前，前纵韧带161和盘环材料162。
图17是在前纵韧带161按需包裹和固定于植入物周围形成所需的植入物几何构型之后，图16的同种异体/异种盘植入物160的平面图。图18是图17的包裹和固定的盘植入物的侧视图。由图可见，图16-17的同种异体/异种盘植入物利用前纵韧带161，使韧带包裹围绕环面材料162，形成更强、更稳定的植入物。任选地，通过用缝线164精细缝合韧带材料，韧带161固定在环面材料162周围。在最优选的实施方式中，植入物160为立方体形或盒形，韧带161在植入物六个面中的四个上部分地或基本上覆盖环面材料162。
图20-23显示的实施方式在许多方面类似于图9-12所示实施方式，但前纵韧带不包括延伸远离同种异体/异种环面的块。相应地，图20和21显示了同种异体/异种组织200，包括完整的环面202和前纵韧带201。
由图22可见，在所示实施方式中盘核隙203是紧密压实的，以类似于图9所示方式加固植入物并使其更坚实。然而，在图22中，前纵韧带201不包裹围绕盘环202，因此用缝线221将环202的两半固定在一起。这闭合了盘核隙203，形成所需的密实几何构型。
图24显示了植入物240，其包括同种异体/异种环面242、前纵韧带241和空核隙243。在该实施方式中，用切口245将环242切开，使得环面可卷曲成具有所需几何构型的更强、更坚实的植入物。
图25显示了在如上所述植入物卷曲后，图24的植入物。可用缝线244固定植入物，保持植入物为卷曲形式。如果前纵韧带是作为从环面延伸的翼提供时，可用该翼覆盖卷曲的植入物，如图26所示。
图27和28显示了本发明植入物的可选实施方式。在这些实施方式中，优选在获得所需几何构型后植入物脱水，使得脱水植入物保持所需的几何构型，至少直到植入后的再水合。
图29显示的本发明实施方式中，同种异体/异种材料292覆盖有不是由附着的前纵韧带形成的护套或外壳297。护套或外壳可以是天然材料和可以是同种异体或异种材料、或可以是具有成功植入所需性质的合成材料。如上文实施方式所述，护套或外壳加固和保护植入物，帮助其保持所需的几何构型。图30显示了图29的包裹的植入物的侧视图。
除上述核植入物外，本发明的其它方面还提供了环面塞。这种塞通常用于堵塞环面中的洞，特别用于保留环面环内的天然或合成的核。如核植入物所述，环面塞可由同种异体或异种组织构成，具体是由完整的或部分同种异体或异种环面，和一个或多个同种异体或异种前纵韧带的块构成。
图31-32显示了本发明一个优选的实施方式的环面塞。塞310包括附着于同种异体/异种环面材料312的同种异体/异种前纵韧带311。在该实施方式中，前纵韧带的翼用作帽，以使植入物不从环面中推出或拉出进入核隙。在最优选的实施方式中，通过将韧带缝合至环面外侧，使前纵韧带311固定于所需植入的环面。
图33-34显示了本发明另一个优选的实施方式的环面塞。塞330包括附着于同种异体/异种环面材料332的同种异体/异种前纵韧带331。在该实施方式中，环面材料332比上述实施方式所用的环面部分要长，使环面材料的两个“臂”335和336折叠在一起形成较厚的塞。优选地，用缝线334将臂335和336缝合到一起，以保持环面塞所需的几何构型。
图35-40显示了本发明环面塞的其它实施方式。所有这些实施方式开始时使用完整的同种异体/异种环面，如图35和36所示。塞可采取如图37和38所示的构型，通过使植入物以所需构型脱水，或塞可采取如图39和40所示的构型，通过精细缝合空核隙实现。
图41-47显示了本发明环面塞的其它实施方式。在这些实施方式中，使用完整的同种异体/异种环面412，但用切口415切开环面以使环面更易于折叠到一起。图41和42显示了形成切口415后，但在环面部分移动至所需构型之前，同种异体/异种环面412的一个实施方式。在图42中，前纵韧带具有延伸远离环面的块，如上所述。因此，塞420包括前纵韧带421，其自由端426和427从环面材料422向外延伸。当将两块环面412折叠和缝合到一起时，如图43和44所示，塞可用于堵塞环面中的洞，其自由端426和427用于将塞固定于需要植入的环面。
图45-47显示的实施方式类似于上文所述，但前纵韧带451不具有延伸远离环面的块。因此，在前纵韧带上切开的环面的两臂可折叠到一起，优选用缝线461缝合到一起。切开的环面451的两臂466和467可用于保持塞被推入所需植入的环面。
图48-52显示了制备本发明植入物的优选实施方式。在该实施方式中，如图48所示，从压缩的完整盘环481(图48A)或盘环482的拉直段(图48B)形成一定长度的盘环材料。防止多孔材料模具490如外科不锈钢网置于盘环材料周围，用于径向向内压缩材料，模具的开口491足够大以使水份通过。通过向内推压围绕盘环材料481的模具490，可将该材料压制成更坚实的尺寸，如植入物501所示。所示压缩的植入物501包括具有中部502和两个端部503和504的植入物。
在优选的实施方式中，压缩的植入物501脱水以保持其坚实形状。脱水后，可进一步成形植入物501，例如具有减小直径的末端503，如圆形端506或尖端507。
在一些实施方式中，模具是两片式模具，如图48所示。在其它实施方式中，“模具”是简单的一片式结构，如多孔板530。当使用多孔板时，通过卷板530更紧固，以使模具内径减小，围绕植入物的“模具”压缩。
为制备和使用本发明植入物，首先从合适的对象，优选是尸体，获取植入物材料。将该材料切割成合适大小，需要时，铸成所需的植入物几何构型。通过将植入物缝合成所需形状以维持所需的几何构型，和/或通过脱水和/或冻干植入物以维持所需构型。
然后，使用本领域技术人员已知的外科技术，用外科手术将植入物植入患者。若植入物是核植入物，在植入替代核之前先除去有缺陷的核，或使用核植入物以增强原来的核。若植入物是环面塞，通常在进行其中含核的手术后，使用该植入物来堵塞盘环中的洞。环面塞使修复或替代的核保持在环面环内，防止修复或替代的核从盘环内移动出。
在一个优选的实施方式中，使用一端为尖端541的脱水、杆形植入物540，首先穿刺待增强或修复的盘的环面542，如图54所示。优选使用针(未示出)实现该目的。植入物540位于导向管543内以便于植入。
将植入物540的尖端541推过穿刺，使植入物540的末端进入盘核隙545，如图55所示。
例如通过使用栓塞561从针推动植入物，使脱水植入物540沉积于盘核隙545内，如图56所示。植入物处于适当位置后，其再水合以获得其正常尺寸，如图57所示。再水合的植入物不再匹配通过小穿孔开口，因而保留在盘核隙内。
实施例
进行可行性实验以证明使用脱水盘环的盘增强效力。在本研究中，收集猪的盘环，盘环脱水形成拉长的构型，切割成较短的片段，插入另一个猪盘中，使其在盘隙内重建。然后，切开增强的猪盘用于观察。至于实验的细节，从猪的脊柱切割猪盘用于研究，如图58所示。在一个终板表面将盘切成两半，以尽可能多地保留环面，如图59所示。在对侧终板的右边切割除去前环面，如图60所示。将环卷曲在不含棉绒的纸上用于干燥和成形，如图61A-61C所示。将环样本置于干燥器中3天。从纸上取下脱水环面，得到脱水盘环，如图62所示。用探针膨胀通过处理的盘环的通道，将干燥的环面切成合适长度并通过膨胀的环面通道插入到盘隙中，如图63所示。将处理的猪盘置于盐水中，在冰箱中保存20小时，然后在37℃下温浴4小时。切开处理的猪盘用于检查。
发现刚性拉长的猪环面的段吸收盘隙内的水份，溶胀，变成较大和更顺应的环面组织，如图64所示。得到有效的盘增强作用。而且，重建和扩大的环面组织保留在增强的盘隙内，且不会通过环面中的通道被排除。
虽然在附图和上述说明中已详细阐述和叙述了本发明，但这些附图和说明是示例性而非限制性的，应理解只显示和描述了优选的实施方式，需要保护本发明精神内的所有改变和改进。

Claims (100)

1.一种椎间盘植入物，其包括基本上不含盘核材料和盘终板材料的同种异体或异种盘环材料。
2.如权利要求1所述的椎间盘植入物，其特征在于，所述盘植入物基本上由同种异体或异种盘环材料构成。
3.如权利要求1所述的椎间盘植入物，其特征在于，所述同种异体或异种盘环材料包括完整的盘环。
4.如权利要求1所述的椎间盘植入物，其特征在于，所述同种异体或异种盘环材料包括一段盘环。
5.如权利要求1所述的椎间盘植入物，其特征在于，所述盘植入物还包括同种异体或异种前纵韧带材料。
6.如权利要求5所述的椎间盘植入物，其特征在于，所述同种异体或异种前纵韧带附着于所述同种异体或异种盘材料。
7.如权利要求5所述的椎间盘植入物，其特征在于，所述同种异体或异种前纵韧带包括从所述同种异体或异种盘材料向外延伸的自由端。
8.如权利要求7所述的椎间盘植入物，其特征在于，所述同种异体或异种前纵韧带的自由端包裹围绕所述同种异体或异种盘环材料。
9.如权利要求7所述的椎间盘植入物，其特征在于，所述同种异体或异种前纵韧带的自由端被固定在一起。
10.如权利要求9所述的椎间盘植入物，其特征在于，用缝线、肘钉或粘合剂将所述同种异体或异种前纵韧带的自由端固定在一起。
11.如权利要求1所述的椎间盘植入物，其特征在于，所述植入物包括一块以上同种异体或异种盘环材料。
12.如权利要求11所述的椎间盘植入物，其特征在于，所述植入物包括一个以上完整的盘环。
13.如权利要求11所述的椎间盘植入物，其特征在于，所述植入物包括一段以上的同种异体或异种盘环。
14.如权利要求11所述的椎间盘植入物，其特征在于，所述植入物还包括至少一块同种异体或异种前纵韧带。
15.如权利要求14所述的椎间盘植入物，其特征在于，所述至少一块同种异体或异种前纵韧带具有至少一个从所述同种异体或异种盘材料向外延伸的自由端。
16.如权利要求3所述的椎间盘植入物，其特征在于，所述完整的盘环被折叠或卷曲成更紧密的结构。
17.如权利要求16所述的椎间盘植入物，其特征在于，切割所述完整的盘环，以便将环折叠或卷曲成更紧密的结构。
18.如权利要求16所述的椎间盘植入物，其特征在于，所述完整的盘环在折叠或卷曲成更紧密的结构后脱水。
19.如权利要求16所述的椎间盘植入物，其特征在于，在折叠或卷曲成更紧密的结构后缝合或胶粘所述完整的盘环。
20.如权利要求3所述的椎间盘植入物，其特征在于，所述完整的盘环被包裹在护套或外壳中。
21.如权利要求20所述的椎间盘植入物，其特征在于，所述护套或外壳由同种异体或异种组织构成。
22.如权利要求20所述的椎间盘植入物，其特征在于，所述护套或外壳由合成材料构成。
23.如权利要求4所述的椎间盘植入物，其特征在于，将所述盘环段折叠或卷曲成更紧密的结构。
24.如权利要求23所述的椎间盘植入物，其特征在于，所述盘环段在折叠或卷曲成更紧密的结构后脱水。
25.如权利要求23所述的椎间盘植入物，其特征在于，在折叠或卷曲成更紧密的结构后缝合或胶粘所述盘环段。
26.如权利要求4所述的椎间盘植入物，其特征在于，所述盘环段被包裹在护套或外壳中。
27.如权利要求26所述的椎间盘植入物，其特征在于，所述护套或外壳由同种异体或异种组织构成。
28.如权利要求26所述的椎间盘植入物，其特征在于，所述护套或外壳由合成材料构成。
29.一种增强或替代椎间盘核的方法，所述方法包括以下步骤：
(a)提供椎间盘植入物，其包括基本上不含盘核材料和盘终板材料的同种异体或异种盘环材料；和
(b)将所述椎间盘植入物植入椎间盘核隙中。
30.如权利要求29所述的方法，其特征在于，所述椎间盘植入物基本上由盘环材料构成。
31.如权利要求29所述的方法，其特征在于，所述椎间盘植入物包括同种异体或异种盘环材料，所述同种异体或异种盘环材料包括完整的盘环。
32.如权利要求29所述的方法，其特征在于，所述椎间盘植入物包括同种异体或异种盘环材料，所述同种异体或异种盘环材料基本上由盘环段构成。
33.如权利要求29所述的方法，其特征在于，所述椎间盘植入物还包括同种异体或异种前纵韧带。
34.如权利要求33所述的方法，其特征在于，所述同种异体或异种前纵韧带附着于所述同种异体或异种盘材料。
35.如权利要求33所述的方法，其特征在于，所述同种异体或异种前纵韧带具有从所述同种异体或异种盘材料向外延伸的自由端。
36.如权利要求35所述的方法，其特征在于，所述同种异体或异种前纵韧带的自由端包裹围绕所述同种异体或异种盘环材料。
37.如权利要求35所述的方法，其特征在于，所述同种异体或异种前纵韧带的自由端被固定在一起。
38.如权利要求37所述的方法，其特征在于，用缝线、肘钉或粘合剂将所述同种异体或异种前纵韧带的自由端固定在一起。
39.如权利要求29所述的方法，其特征在于，所述椎间盘植入物包括一块以上同种异体或异种盘环材料。
40.如权利要求39所述的方法，其特征在于，所述椎间盘植入物包括一个以上完整的盘环。
41.如权利要求39所述的方法，其特征在于，所述椎间盘植入物包括一段以上的同种异体或异种盘环材料。
42.如权利要求39所述的方法，其特征在于，所述椎间盘植入物还包括至少一块同种异体或异种前纵韧带材料。
43.如权利要求42所述的方法，其特征在于，所述至少一块同种异体或异种前纵韧带具有至少一个从所述同种异体或异种盘材料向外延伸的自由端。
44.如权利要求31所述的方法，其特征在于，所述完整的盘环被折叠或卷曲成更紧密的结构。
45.如权利要求44所述的方法，其特征在于，切割所述完整的盘环，以便将环折叠或卷曲成更紧密的结构。
46.如权利要求44所述的方法，其特征在于，所述完整的盘环在折叠或卷曲成更紧密的结构后脱水。
47.如权利要求44所述的方法，其特征在于，在折叠或卷曲成更紧密的结构后缝合或胶粘所述完整的盘环。
48.如权利要求31所述的方法，其特征在于，所述完整的盘环被包裹在护套或外壳中。
49.如权利要求48所述的方法，其特征在于，所述护套或外壳由同种异体或异种组织构成。
50.如权利要求48所述的方法，其特征在于，所述护套或外壳由合成材料构成。
51.如权利要求32所述的方法，其特征在于，将所述盘环段折叠或卷曲成更紧密的结构。
52.如权利要求51所述的方法，其特征在于，所述盘环段在折叠或卷曲成更紧密的结构后脱水。
53.如权利要求51所述的方法，其特征在于，在折叠或卷曲成更紧密的结构后缝合所述盘环段。
54.如权利要求32所述的方法，其特征在于，所述盘环段被包裹在护套或外壳中。
55.如权利要求54所述的方法，其特征在于，所述护套或外壳由同种异体或异种组织构成。
56.如权利要求54所述的方法，其特征在于，所述护套或外壳由合成材料构成。
57.一种堵塞椎间盘环中的洞的方法，所述方法包括以下步骤：
(a)提供包括同种异体或异种盘环材料的椎间盘植入物；和
(b)将所述椎间盘植入物植入椎间盘环的洞中以堵塞所述的洞。
58.如权利要求57所述的方法，其特征在于，所述椎间盘植入物基本上由盘环材料构成。
59.如权利要求57所述的方法，其特征在于，所述同种异体或异种盘环材料包括完整的盘环。
60.如权利要求57所述的方法，其特征在于，所述同种异体或异种盘环材料包括一段盘环。
61.如权利要求57所述的方法，其特征在于，所述椎间盘植入物还包括同种异体或异种前纵韧带。
62.如权利要求61所述的方法，其特征在于，所述前纵韧带附着于所述同种异体或异种盘材料。
63.如权利要求61所述的方法，其特征在于，所述前纵韧带具有从所述同种异体或异种盘材料向外延伸的自由端。
64.如权利要求63所述的方法，其特征在于，所述同种异体或异种前纵韧带的自由端包裹围绕所述同种异体或异种盘环材料。
65.如权利要求63所述的方法，其特征在于，所述同种异体或异种前纵韧带的自由端被固定在一起。
66.如权利要求65所述的方法，其特征在于，用缝线、肘钉或粘合剂将所述同种异体或异种前纵韧带的自由端固定在一起。
67.如权利要求57所述的方法，其特征在于，所述椎间盘植入物包括一块以上同种异体或异种盘环材料。
68.如权利要求67所述的方法，其特征在于，所述椎间盘植入物包括一个以上完整的盘环。
69.如权利要求67所述的方法，其特征在于，所述椎间盘植入物包括一段以上的同种异体或异种盘环材料。
70.如权利要求67所述的方法，其特征在于，所述椎间盘植入物还包括至少一块同种异体或异种前纵韧带材料。
71.如权利要求70所述的方法，其特征在于，所述至少一块同种异体或异种前纵韧带具有至少一个从所述同种异体或异种盘材料向外延伸的自由端。
72.如权利要求59所述的方法，其特征在于，所述完整的盘环被折叠或卷曲成更紧密的结构。
73.如权利要求72所述的方法，其特征在于，切割所述完整的盘环，以便将环折叠或卷曲成更紧密的结构。
74.如权利要求72所述的方法，其特征在于，所述完整的盘环在折叠或卷曲成更紧密的结构后脱水。
75.如权利要求72所述的方法，其特征在于，在折叠或卷曲成更紧密的结构后缝合或胶粘所述完整的盘环。
76.如权利要求59所述的方法，其特征在于，所述完整的盘环被包裹在护套或外壳中。
77.如权利要求76所述的方法，其特征在于，所述护套或外壳由同种异体或异种组织构成。
78.如权利要求76所述的方法，其特征在于，所述护套或外壳由合成材料构成。
79.如权利要求60所述的方法，其特征在于，将所述盘环段折叠或卷曲成更紧密的结构。
80.如权利要求79所述的方法，其特征在于，所述盘环段在折叠或卷曲成更紧密的结构后脱水。
81.如权利要求79所述的方法，其特征在于，在折叠或卷曲成更紧密的结构后缝合所述盘环段。
82.如权利要求60所述的方法，其特征在于，所述盘环段被包裹在护套或外壳中。
83.如权利要求82所述的方法，其特征在于，所述护套或外壳由同种异体或异种组织构成。
84.如权利要求82所述的方法，其特征在于，所述护套或外壳由合成材料构成。
85.如权利要求1所述的椎间盘植入物，其特征在于，所述植入物包括一段已被拉直的盘环，形成基本上杆形的植入物。
86.如权利要求85所述的椎间盘植入物，其特征在于，所述基本上杆形的植入物至少一端的直径减小。
87.如权利要求85所述的椎间盘植入物，其特征在于，所述基本上杆形的植入物至少一端基本上是尖的。
88.如权利要求85所述的椎间盘植入物，其特征在于，所述基本上杆形的植入物受到使植入物表面径向向内移动的力，提供在受所述的力之前直径小于盘环段直径的植入物。
89.如权利要求88所述的椎间盘植入物，其特征在于，所述基本上杆形的植入物在受到使植入物表面径向向内移动的力之后脱水，提供直径小于水合段直径的脱水植入物。
90.如权利要求89所述的椎间盘植入物，其特征在于，所述脱水植入物至少一端的直径减小。
91.如权利要求89所述的椎间盘植入物，其特征在于，所述脱水植入物至少一端基本上是尖的。
92.如权利要求29所述的方法，其特征在于，所述椎间盘植入物包括一段已被拉直的盘环，提供基本上杆形的植入物。
93.如权利要求29所述的方法，其特征在于，所述基本上杆形的植入物至少一端的直径比其原来的直径小。
94.如权利要求29所述的方法，其特征在于，所述基本上杆形的植入物至少一端基本上是尖的。
95.如权利要求29所述的方法，其特征在于，所述基本上杆形的植入物受到使植入物径向向内压缩的力，提供在压缩前直径小于盘环段直径的植入物。
96.如权利要求95所述的方法，其特征在于，所述脱水植入物至少一端的直径小于植入物其余部分的直径。
97.如权利要求95所述的方法，其特征在于，所述脱水植入物至少一端基本上是尖的。
98.如权利要求95所述的方法，其特征在于，所述基本上杆形的植入物压缩后脱水。
99.如权利要求98所述的方法，其特征在于，所述脱水植入物至少一端的直径小于植入物其余部分的直径。
100.如权利要求98所述的方法，其特征在于，所述脱水植入物至少一端基本上是尖的。
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ATE417579T1 (de) 2009-01-15
KR101090631B1 (ko) 2011-12-08
DE602004018526D1 (de) 2009-01-29
AU2004270131A1 (en) 2005-03-17
US20050043801A1 (en) 2005-02-24
KR20060120600A (ko) 2006-11-27
JP4512095B2 (ja) 2010-07-28
CN1859883B (zh) 2010-07-14
CA2536511A1 (en) 2005-03-17
US7309359B2 (en) 2007-12-18
US9011543B2 (en) 2015-04-21
WO2005023156A1 (en) 2005-03-17
EP1673044A1 (en) 2006-06-28
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