CN101360469A - 用于人工椎间盘置换术的机械产品和方法 - Google Patents

用于人工椎间盘置换术的机械产品和方法 Download PDF

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Publication number
CN101360469A
CN101360469A CNA2006800509797A CN200680050979A CN101360469A CN 101360469 A CN101360469 A CN 101360469A CN A2006800509797 A CNA2006800509797 A CN A2006800509797A CN 200680050979 A CN200680050979 A CN 200680050979A CN 101360469 A CN101360469 A CN 101360469A
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China
Prior art keywords
ring
inflatable ring
solution
hydrogel
biocompatible
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CNA2006800509797A
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CN101360469B (zh
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杰罗姆·西格尔
马太·约尔克
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OuroBoros Medical Inc
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OuroBoros Medical Inc
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Landscapes

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Abstract

本发明大体上涉及可用于在脊柱手术期间加固原本纤维环的设备和方法。该设备是在通过传统的手术方法或内窥镜方法进行摘除术之后放入椎间空间内的基于导管的设备。该导管的远端包括由机织或编织材料形成的可膨胀环，以帮助经由所述装置引入到椎间空间内的生物相容性容剂和生物相容性聚合物的引入。

Description

用于人工椎间盘置换术的机械产品和方法
技术领域
本发明总体涉及用于修复椎间盘的设备和方法。更具体地说，本发明涉及用于治疗与髓核、纤维环和椎间盘相关的脊柱病的设备和方法。
背景技术
椎间盘疾病是世界范围内的主要健康问题。仅仅在美国，每年进行大约700,000例脊椎手术，治疗背痛的总成本超过300亿美元。椎间盘中与年龄相关的变化包括在生命的第4个十年时髓核中的水含量降低，胶原质含量增加。髓核结合的水降低导致纤维环受到更大的压缩载荷。这导致纤维环更容易分层和受损。纤维环的受损又加速了椎间盘退变和诸如小关节之类的周围组织的退变。
所进行的两种最常见的脊椎外科手术是髓核摘除术和脊椎融合术。这些手术仅仅解决了下腰痛(lower back pain)的症状。实际上这两种手术都使患病椎间盘和相邻椎间盘的整体情况恶化。较好的解决方案是植入人工椎间盘，用于治疗下腰痛并恢复患病椎间盘的正常形态和功能。
椎间盘假体的概念要追溯到1956年van Steenbrugghe的法国专利。17年后，Urbaniak报告了植入动物的首例椎间盘假体。自此，已经提出并测试了许多用于椎间盘置换术的现有技术设备。这些设备通常分为用于人工全椎间盘置换术的设备或用于人工髓核置换术的设备。所提出用于人工全椎间盘置换术的设备(例如Kostuik研发的设备)通常包括一些附接到金属终板的柔性中央部件，该金属终板可固定至相邻椎骨。柔性部件可呈弹簧或者聚乙烯芯(Marnay)的形式。至今应用最广泛的植入全人工椎间盘是Link SB Charite椎间盘，其由分子量特别高的双凸聚乙烯垫片构成，该垫片与两个由钴-铬-钼合金制成的终板相交接。其中有超过2000例被植入并获得良好的效果。然而，已有关于脱位和移位的设备失效报告。Charite椎间盘还需要借助前入路的大范围手术解剖。
人工髓核置换术的方法相比人工全椎间盘置换术具有几个明显的优点。通过仅置换髓核，保存了其余的椎间盘结构，例如纤维环和终板，并且保存了它们的功能。由于纤维环和终板完整保留，所以手术过程简单得多，且手术时间较短。可以经由最低侵入式内镜方式来放置几个髓核假体。当今应用最广泛的髓核植入物是由Raymedica(Bloomington，MN)研发的，其包括约束在织成的聚乙烯套中的水凝胶芯。丸状水凝胶芯在放置前被压缩脱水至最小尺寸。在植入后水凝胶开始吸收流体并膨胀。柔性但无弹性的套使水凝胶可以随着压力变形和重新成形，却仍然抑制其水平和垂直膨胀(参见授予Ray的美国专利No.4,904,260和4,772,287)。已描述了其它类型的髓核置换物，它们包括膨胀性的水凝胶或聚合物以提供椎间盘分离并减轻作用在其它椎间盘部件上的压缩载荷(参见授予Boa的美国专利No.5192326)。髓核假体的主要限制在于，它们只能用在椎间盘退变处于早期阶段的病人中，因为它们需要有着适宜的天然纤维环。在处于退变后期阶段的椎间盘中，纤维环常常撕裂、变平并且/或者分层并且强度不足以提供所需的约束。此外，人工髓核的放置常常需要通过纤维环进入。这在纤维环中遗留缺口，人工髓核最终可能通过该缺口突出而压迫相邻结构。显然需要对可能与这些各种髓核置换设备结合使用的天然纤维环进行置换或加固。
早先已经描述了几种纤维环修复或加固设备。这些设备包括由以下文献描述的纤维环加固带：授予Kuslich的美国专利No.6,712,853，该专利描述了一种膨胀带，其受到使该带膨胀的骨移植物材料等的加压；授予Lambrecht等的美国专利No.6883520B2，该专利描述了一种利用锚件和膜封闭纤维环缺口来约束椎间盘形成疝的设备和方法；授予Slivka等的美国专利申请No.10/676868，该专利申请描述了一种脊椎间盘缺口修复方法；授予Keith等的美国专利6,806,595 B2，该专利描述了通过围绕椎间盘的纤维环植入加强部件进行椎间盘加固；授予Cauthen的美国专利6,592,625 B2，该专利描述了一种穿过子环形空间中的孔的可折叠贴片；授予Milbocker等的美国专利申请No.10/873,899，该专利申请描述了注射原位聚合化流体，用于修复削弱了的纤维环纤维变性(annulus fibrosis)，或者置换或增强椎间盘髓核。
这些现有技术文献中的每一个都描述了用于修复患病纤维环的至少一部分的设备或方法。明显需要的是一种能够在周向上加固整个纤维环的改进了的脊椎间盘设备和方法。此外，明显需要的是一种可容易地放在椎间空间中并适应该空间的脊椎间盘设备和方法。明显需要的是一种能够加固整个纤维环的改进了的脊椎间盘设备和方法，该设备和方法可与人工髓核结合使用，或者可用作对纤维环纤维变性的加固以及用作人工髓核。
发明内容
本发明通过提供用于治疗椎间盘疾病的改进的脊椎间盘设备和方法而满足所述需求。本发明的改进的设备和方法特别地消除椎间盘相关的痛苦，但是也可以具有本文未特别提及的其它明显应用。参照成人脊柱的受损椎间盘的治疗而详细地描述本发明，这仅仅是为了例示而不是加以限制。
从以下详细描述中可以清楚，本发明的改进的脊椎间盘设备和方法可以减轻(如果不能消除)背痛，同时保持接近正常的解剖学运动。本发明涉及可用于加固或置换原本纤维环(native annulus)、置换原本纤维环、置换纤维环和髓核或利于相邻脊椎的熔合的设备和方法。本发明的设备特别适于最小程度的侵入性植入方法。
脊椎间盘设备是基于导管的设备，其在通过传统的手术或内窥镜径路进行摘除术之后放入椎间空间内。所述导管的远端包括可膨胀环，该可膨胀环可以通过控制元件的前进或缩回而增大直径，该控制元件包括可通过由导管近端操纵的导管的柔性部分，该近端保持在主体外部。所述可膨胀环或网可由机织、针织、或编织材料形成，并且可由尼龙、涤纶、合成聚酰胺、膨体聚四氟乙烯(e-PTFE)、可商购获得的称为SpectraTM或DyneemaTM的聚乙烯和聚乙烯的超高分子量纤维(UHMWPE)，以及用于各种外科手术的其它拉伸强度高的材料，例如VectranTM、KevlarTM、天然或人工生产的丝线和可商购获得的缝线材料制成。或者，所述导管的所述可膨胀环或网的部分可由在一段时间后分解并由病人生物吸收的可生物降解或生物吸收的材料制成，例如可重吸收的胶原质、LPLA(聚(1-丙交酯))、DLPLA(聚(dl-丙交酯))、LPLA-DLPLA、PGA(聚乙交酯)、PGA-LPLA或PGA-DLPLA、聚乳酸和聚乙醇酸。或者，所述导管的可膨胀部分可由金属材料制成，例如不锈钢、埃尔吉洛伊耐蚀游丝合金(elgiloy)、镍钛合金或其它生物相容性金属。另外，预见到所述设备的可膨胀环部分可由弄平的管状针织、机织、网或泡沫结构制成。
所述可膨胀环可形成为使得当所述环径向收缩时，所述环的一端馈入其另一端，与蛇食其尾类似。或者，所述可膨胀环可形成为使其在径向收缩时，呈自身套叠的环形形状。从而稳定所述环的外部并拉出内部会使所述环的整体直径增大，同时使其保持基本闭合的环或环形。
在一个实施方式中，本发明包括一种设备和方法，由此本发明首先被输送到椎间空间中并在该椎间空间中膨胀至原本纤维环的内部的极限，以加固或人工置换原本纤维环。
在另一实施方式中，本发明包括一种设备和方法，由此本发明首先被输送到椎间空间中并在该椎间空间中膨胀至原本纤维环的内部的极限，然后进行聚合物或水凝胶等材料的注射，以加固或人工置换原本纤维环。
在另一实施方式中，本发明包括一种设备和方法，由此本发明首先被输送到椎间空间中并在该椎间空间中膨胀至原本纤维环的内部的极限，然后本发明的内部在放入椎间空间内的同时或之前向中央膨胀至人工纤维环的极限。
在另一实施方式中，本发明包括一种设备和方法，由此本发明首先被输送到椎间空间和髓核(可能已经被预先移除)的区域中，并膨胀至原本纤维环区域的外部的极限，然后进行聚合物或水凝胶等材料的注射，以加固或人工置换原本髓核。
在另一实施方式中，本发明包括一种设备和方法，由此本发明首先被输送到椎间空间中并在该椎间空间中膨胀至原本纤维环的外部的极限，然后进行聚合物或水凝胶材料的注射，以加固或人工置换原本纤维环。然后，本发明被输送到髓核区中并膨胀至原本髓核或同时放置的人工髓核的外部的极限，然后进行聚合物或水凝胶材料的注射，以加固或人工置换或加固髓核。
在另一实施方式中，本发明包括一种设备和方法，由此本发明首先被输送到椎间空间中并在该椎间空间中膨胀，并且从纤维环的外极限向内膨胀达到在环形中基本没有留下中央孔的程度，并向所述可膨胀网中注射聚合物或水凝胶等材料。
在另一实施方式中，本发明包括一种设备和方法，由此本发明被输送到椎间空间中并在该椎间空间中膨胀，然后注射骨移植物材料、聚合骨移植物化合物，或者诱导或促进骨生长的材料，例如但不限于生长因子、BMP等，从而有利于相邻椎骨的熔合。
这里概述了本发明及其实施方式的变型。本发明的附加细节以及本发明的实施方式可在以下优选实施方式的详细说明及权利要求中找到。参照以下说明和权利要求将更好地理解本发明的这些和其它特征、方面和优点。
附图说明
图1是本发明一个实施方式的剖面图，其中控制元件附接至可膨胀环的内部远端，且处于收缩输送构造。
图2是本发明一个实施方式的剖面图，其中控制元件附接至可膨胀环的内部远端，且鞘缩回从而可膨胀环露出。
图3是本发明一个实施方式的剖面图，其中控制元件附接至可膨胀环的内部远端，该可膨胀环处于膨胀构造。
图4是本发明一个实施方式的剖面图，其中控制元件附接至可膨胀环的内部远端，该可膨胀环处于膨胀构造，可膨胀环的内周处于收缩构造。
图5是本发明的图4的放大剖面图，其中控制元件附接至可膨胀环的内部远端，并示出了可膨胀环的控制端。
图6是本发明另一实施方式的剖面图，其中控制元件引出可膨胀环的外部侧壁，并且可释放地连接到可膨胀环的外部的近侧部分，该可膨胀环示出为处于收缩输送构造。
图7是本发明另一实施方式的剖面图，其中鞘缩回从而可膨胀环露出。
图8是图1的实施方式的剖面图，其中可膨胀环处于膨胀构造。
图9是本发明的图8的放大剖面图，示出了可膨胀环的控制端。
图10是具有两个控制元件并处于收缩输送构造的本发明另一实施方式的剖面图。
图11是具有两个控制元件的本发明另一实施方式的剖面图，其中鞘缩回从而可膨胀环露出。
图12是具有两个控制元件的本发明另一实施方式的剖面图，其中可膨胀环处于膨胀构造。
图13是具有两个控制元件的本发明另一实施方式的剖面图，其中可膨胀环处于膨胀构造，可膨胀环的内周处于收缩构造。
图14是脊椎体(椎骨)的俯视剖面图，示出了前进至椎间空间中的后外侧进入管。
图15是脊椎体(椎骨)的俯视剖面图，其中本发明的一个实施方式位于脊椎体(椎骨)的椎间空间内。
图16是脊椎体(椎骨)的俯视剖面图，其中本发明的一个实施方式膨胀并包围脊椎体(椎骨)的髓核部。
图17是脊椎体(椎骨)的俯视剖面图，其中在脊椎体(椎骨)的椎间空间内本发明的一个实施方式的外径膨胀而内径收缩。
图18是具有直径D和高度H的、处于部分膨胀构造的可膨胀环的剖面尺寸图。
图19是直径增加+D且高度增加+H的、处于膨胀构造的可膨胀环的剖面尺寸图。
图20是本发明另一实施方式的剖面图，其中可膨胀环处于套叠构造(由此可膨胀环的一部分向后弯曲并进入其自身)，且可膨胀环处于部分膨胀构造。
图21是包括内导管或控制元件的本发明的附加特征的剖面图，所述内导管或控制元件具有多个用于输送和注射生物材料的孔。
图22是本发明的元件的立体图，其中可膨胀内环的远端上的锁定元件结合至可膨胀外环。
具体实施方式
如图1至5所示，脊椎盘设备的一个实施方式10、11包括细长探针15，细长探针15具有近端17和远端16。参照图1和图2，可以看到细长探针15由至少两个元件构成，即，柔性的内导管控制元件19和较刚性的外导管元件12。内导管控制元件19可滑动地位于外导管元件12内。在细长探针15的近端17，内导管控制元件19从外导管12出来，并且可前进或缩回，使得内导管控制元件19的远端20进出外导管元件12的远端13。在细长探针15的远端16附近设有处于收缩或输送构造下的可膨胀、编织或机织的管状环24(图1)。内导管控制元件19在外导管元件12的远端13附近进入可膨胀环24并可滑动地位于可膨胀环24中。可膨胀环24的远端22以类似于蛇食其尾的方式被馈入可膨胀环24的近端23中。这样产生了具有如图1和图2所示的内部和外部的可膨胀环24。在细长探针15上放置可缩回的覆盖鞘18以将细长探针15保持在用于输送至椎间盘中的受约束情况下。在鞘18缩回后，可通过使可膨胀环24的远端22从外部可膨胀环24的近端23退出而使可膨胀环24周向直径增大(图3)。在该构造中，此时在膨胀了的可膨胀环25内限定出基本连续的内部腔室28。外导管元件12终止于其远端13并且可移除地附接到膨胀了的可膨胀环25的外部的近端23。呈细丝、导丝或柔性管形式的内导管控制元件19可滑动地从导管或探针15的近端17延伸，穿过外导管元件12，并在其远端13引出外导管元件。然后内导管元件在可膨胀环的近端23进入可膨胀环的外部内侧。在内导管元件19或控制元件在可膨胀环24、25的远端22、26终止在可膨胀环内之前，内导管控制元件19可以在可膨胀环24、25的内部与外部之间在所述环内绕一圈、少于一圈或多于一圈。然后内导管控制元件19在可膨胀环24、25的内部的远端22、26处附接至可膨胀环24、25。
内导管控制元件可由柔性但纵向不可压缩的材料制成，例如但不限于直径为0.010”-0.040”的不锈钢或镍钛合金丝。在将可膨胀环23、27的外部的近侧部保持在适当位置的同时使内导管元件19通过外导管元件12可滑动地前进会导致可膨胀环24、25的内部被拉出可膨胀环24、25的外部。这会导致可膨胀环24、25的整体径向膨胀。如图4所示，一旦实现并固定了可膨胀环25的外周膨胀，则在保持可膨胀环25的外部27被固定的同时拉出内导管控制元件19就使可膨胀环25的内周收缩，同时使其高度膨胀。通过可膨胀环24、25的材料结构的弹簧特性或通过在保持可膨胀环23的近侧外部被固定的同时使内导管控制元件19前进而使可膨胀环25膨胀至椎间空间中。接着，在保持可膨胀环25的近侧外部27被固定的同时继续拉动内导管控制元件19，使可膨胀环25的内周朝向可膨胀环25的中心收缩，同时可膨胀环25的高度增加。
图5是本发明的实施方式的图4的放大剖面图，其中控制元件附接至可膨胀环25的内部远端26。该图表示可膨胀环25的控制端，以及内导管19的远端20、可膨胀环25的远端26和近端27与外导管元件12之间的物理关系。
用于输送可膨胀环24的外导管元件12应该足够刚硬以允许内导管控制元件19缩回而不会皱缩或扭结。内导管控制元件19必须有足够的柔性以环绕可膨胀环24并获得相对较小的半径而不扭结，还具有足够的拉伸强度以在从其近侧部被拉动时防止断裂。外导管元件12可由聚合材料制造，这些聚合体材料包括但不限于尼龙、涤纶、合成聚酰胺、膨体聚四氟乙烯(e-PTFE)、聚乙烯和聚乙烯的超高分子量纤维(UHMWPE)，或者由金属材料制造，这些金属材料包括但不限于不锈钢、钴-铬合金、钛、钛合金或镍-钛形状记忆合金、以及其它具有足够的抗扭结性和拉伸强度的材料。内导管控制元件19可由尼龙、涤纶、合成聚酰胺、膨体聚四氟乙烯(e-PTFE)、聚乙烯和聚乙烯的超高分子量纤维(UHMWPE)制成，或者由包括但不限于不锈钢、钴-铬合金、钛、钛合金或镍-钛形状记忆合金等金属材料制成。由金属材料制成的元件的直径为从0.001”到0.020”，优选从0.004”到0.010”。由聚合材料制成的元件的直径为从0.005”到0.040”，优选从0.010”到0.020”。
可膨胀环24、25制造成针织、机织或编织物，并且可由不可降解的材料构成。用于可膨胀环24、25的合适的不可降解的材料包括但不限于尼龙、涤纶、合成聚酰胺、膨体聚四氟乙烯(e-PTFE)、可商购获得的称为SpectraTM或DyneemaTM的聚乙烯和聚乙烯的超高分子量纤维(UHMWPE)，以及用于各种外科手术的其它拉伸强度高的材料，例如VectranTM、KevlarTM、天然或人工生产的丝线和可商购获得的缝线材料。制造为机织或编织物的可膨胀环24、25可由可生物降解或可生物吸收的材料构成。用于可膨胀环24、25的合适的可生物降解和可生物吸收的材料包括但不限于可重吸收的胶原质、LPLA(聚(1-丙交酯))、DLPLA(聚(dl-丙交酯))、LPLA-DLPLA、PGA(聚乙交酯)、PGA-LPLA或PGA-DLPLA，以及由聚乳酸和聚乙醇酸制成的可生物降解的缝线。
此外，对于一些实施方式，可使用适当的用于可膨胀环24、25的金属材料，这些金属材料包括但不限于不锈钢、钴-铬合金、钛、钛合金或镍-钛形状记忆合金等。可以进一步考虑，金属网可与不可重吸收的聚合物(例如尼龙纤维、碳纤维和聚乙烯纤维等)交织以形成金属聚合物复合织物。适当的不可重吸收的材料的其它实施例包括DACRON和GORE-TEX。可膨胀环24、25的一个特征在于其孔尺寸或开口需要小到足以保持填充材料或髓核防止它们突出，又要大到足以保持柔性和膨胀特性。
在另一实施方式中，外导管元件12的远端13位于内导管控制元件19的周围。外导管元件12被保持为与可膨胀环24的外部的近端23呈恒定关系或可释放地固定至其上。在该实施方式中，内导管控制元件19呈柔性很大的元件的形式，其进入可膨胀环23的外部中的近侧开口，围绕可膨胀环24的外部的内侧一圈、少于一圈或多于一圈，并且附接在可膨胀环24的内部的远端22处而终止。柔性控制元件19在其进入可膨胀环24的外部并绕圈时，其旋转方向(从控制元件20的远端向着近端21进行测量)是与可膨胀环24的内部的旋转方向相反的旋转方向。在内导管控制元件19的近端21缩回退出外导管元件12时，外导管元件12的远端13在可膨胀环24的内部22被拉出可膨胀环24的外部23的同时使可膨胀环24的外部23稳定并保持在适当位置，从而导致可膨胀环24的直径增大。一旦膨胀了的可膨胀环25到达其最大直径(该最大直径由可膨胀环25在其内膨胀的空间边界确定或者由控制细丝通过膨胀了的可膨胀环25的近端27的引出点确定)，内导管控制元件19的继续缩回就会导致内导管控制元件19在膨胀了的可膨胀环25的内周上产生拉力。膨胀了的可膨胀环25的内周会朝向膨胀了的可膨胀环25的中央收缩，并且膨胀了的可膨胀环25的高度会增加。由于管状可膨胀环24、25的机织或编织特性，膨胀了的可膨胀环25会在其周向膨胀和中央收缩时都保持大致环形形状。
可通过参照图6至图9理解用于修复或置换脊椎的纤维环纤维变性的可膨胀环设备的其他实施方式39、40。如图6至图8所示，内导管控制元件19围绕可膨胀的编织环24的外部的壁，并在外导管元件12与可膨胀环24的外部的近端23的附接部附近通过该壁引出。然后内导管控制元件19固定至外导管元件12，此时使用结点或者可释放或可移除的接合部，或者其在近侧穿过外导管元件12。在细长探针15上放置有可缩回的覆盖鞘18以将其保持在用于输送至椎间盘中的受约束情况下。在鞘18缩回之后，通过可滑动地位于外导管元件12和可膨胀环24内的内导管控制元件19的近侧部形成“套圈”或环。如果内导管控制元件19的刚度足够，例如但不限于是直径为0.010”-0.040”的金属导丝，那么套圈和可膨胀环24可通过使内导管控制元件19的近侧部21前进而打开，同时将外导管元件12和可膨胀环23的近端保持在适当位置。当可膨胀环24的内部被拉出其外部时，由内导管控制元件19形成的套圈的周边的打开会导致可膨胀环24的周边膨胀。一旦膨胀了的可膨胀环25到达膨胀极限，内导管控制元件19就可在外导管12与膨胀了的可膨胀环27的近端的接合部或连接部处分离，并且可滑动地缩出膨胀了的可膨胀环25，留下周向膨胀了的可膨胀环25。
在用于纤维环修复或置换的本发明的替代实施方式中，内导管控制元件19在其附接到外导管元件12之前，在可膨胀环24、25的内部延伸，绕圈并首先从编织环22、26的内部的远端引出，然后通过编织环23、27的外部的壁引出。内导管控制元件或细丝19可在引出和附接到导管元件12之前，在可膨胀环24、25内绕一圈、少于一圈或多于一圈。这样，内导管控制元件19形成一圈以上的“套圈”或环。如果内导管控制元件19的刚度足够，例如但不限于是直径为0.010”-0.040”的金属导丝，那么套圈可通过使内导管控制元件21的近侧部前进而打开，同时将外导管元件12和可膨胀环23、27的近端保持在适当位置。当可膨胀环24、25的内部拉出其外部时，由内导管控制元件19形成的套圈的一个以上的环的周边的打开会导致可膨胀环24、25的周边膨胀。一旦可膨胀环24、25到达膨胀极限，内导管控制元件19就可通过继续拉动其近侧部21而被拉回导管元件12中。这使得套圈的一个以上的环变小，从而继续拉动膨胀了的可膨胀环25的内周，导致膨胀了的可膨胀环25中部的中央空间收缩。由于可膨胀环24、25的机织或编织特性，可膨胀环24、25会在其周向膨胀和中央收缩时都保持大致环形形状。
如图10至图13所示，本发明的另一个实施方式43、44包括细长探针15，细长探针15具有近端17和远端16。参照图10和图11，第一内导管控制元件19可滑动地位于外导管元件12内。在细长探针15的近端17处，内导管控制元件19从外导管元件12引出，并且可前进或缩回，使得内导管控制元件19的远端20进出外导管元件12的远端13。呈细丝、导丝或柔性管形式的第一内导管控制元件19可滑动地从探针15的近端17通过外导管元件12的腔延伸，并在其远端13处引出外导管元件12。然后内导管控制元件19在可膨胀环24的近端23处进入可膨胀环24的外部内侧。在内导管元件或控制元件19终止在可膨胀环24内之前，内导管控制元件19可以在可膨胀环24的内部与外部之间在可膨胀环24内绕一圈、少于一圈或多于一圈。然后内导管控制元件19在可膨胀环24的远端22处附接至可膨胀环24。该实施方式还包括第二内导管控制元件52，其从导管或探针15的近端17延伸经过外导管元件12，并在其远端13处引出外导管元件12。然后第二内导管控制元件52进入可膨胀环24的外部外侧并附接至可膨胀环24的远端22。在细长探针15上放置可缩回的覆盖鞘18以将其保持在用于输送至椎间盘中的受约束情况下。在鞘18缩回后，第二内导管控制元件52通过继续拉动其近端而被拉回外导管控制元件12中。这使得可膨胀环22的远端被从可膨胀环24的外部的内侧拉动，使得可膨胀环24的外周膨胀(见图12)。现在参照图13，第一内导管控制元件19可通过继续拉动其近端而被拉回外导管元件12中。这会导致可膨胀环25的中央被朝向环的中部拉入，以及可膨胀环25中部的中央空间的收缩。由于管状可膨胀环24、25的机织或编织特性，可膨胀环24、25会在其周向膨胀和其中央收缩时都保持大致环形形状。
在图18至20所示的另一实施方式59、60中，可膨胀环58的收缩构造包括具有折回其自身中的或套叠的部分56的可膨胀环58(参见图20)。这形成了完整的环形，其中有一部分套叠以形成具有彼此连续的内部和外部的径向收缩的环形。按如前所述的方式继续拉动内导管控制元件19会使得在环形的中央部分被朝向中心拉动时增大膨胀了的可膨胀环25的直径(+D)和高度(+H)。
现在，为了易于放置，包括周向收缩的编织的可膨胀环24以及内导管控制元件19的整个可膨胀环组件10可压入远侧外导管元件、鞘18内，或者说压入直径约为3-20mm的进入管38内。进入管38可由任何适当的材料形成，本发明在该方面未加以限制。因此，进入管38可由诸如聚碳酸酯等塑料材料，或者诸如不锈钢等金属材料，或者任何适当的材料组合形成。此外，后外侧的进入管38可由易于消毒的材料形成。另外，细长探针15可形成为一次性使用装置，从而使用之后无需重新消毒。后外侧的进入管38一般利用后入路而进入椎骨(图14)。
如图15所示，后外侧的进入管38已经进入具有脊髓33、纤维环36和髓核区34的椎骨32。一旦处于病人的椎骨32内的正确位置，就可通过缩回外导管元件12或鞘18并同时将内导管19和可膨胀环24保持在固定位置，从而将可膨胀环24从外导管元件13的远端、鞘18或进入管38喷射到髓核区33或纤维环区(图中未示出)内。或者，附加的“推动器”元件(未示出)可从远侧前进至外导管元件12或鞘18或进入管中并从鞘18的端部喷射可膨胀环24、导管元件12和远侧内导管控制元件20。如前述实施方式所述，可膨胀环24现在可通过按照上述方式继续拉动或推动内导管控制元件19而周向膨胀。另外，如果期望编织的可膨胀环24的中央部分周向收缩，那么如上所述继续拉动内导管控制元件19可实现该特征。
现在参照图16和图17，膨胀了的可膨胀环25实现了期望的外周膨胀(图16)和内周部分收缩的尺寸48，且中央区域34部分收缩。在图17中，该中央区域如果充分收缩则导致小直径的环形37。此时，内导管控制元件19通过结点被锁定或绑在适当位置。这也可通过位于外导管元件12处的锁定接合部而实现。现在外部内导管控制元件19的远侧部20可从连接器或靠近结点断开或切断。连接器或结点也与远侧外导管元件12分离。因而这样在适当位置形成了外周膨胀而内周收缩的可膨胀环25，从而形成位于椎间空间内期望位置(图16所示，其中髓核区34膨胀)处的闭合环。
现在参照图18，图18示出了处在部分膨胀结构下、直径为D高度为H的可膨胀环的剖面尺寸图。在图19中，膨胀环的剖面尺寸图处在膨胀结构下，其中示出了本发明可膨胀环的独特特征。在向控制元件19施加拉力时，外径+D膨胀，同时高度+H增加(直径方向上膨胀和收缩)。本发明还可同时减小中央区域34的直径，这在这些附图中没有示出。所产生的结构包括容纳在可膨胀环内的内腔室28以及由可膨胀环环绕的中央区域34。而且，通过控制元件使可膨胀环膨胀能不成比例地收缩所述中央区域34，从而中央区域的腰部被压缩成具有比终端部小的直径。
图20为本发明的另一实施方式的剖面图，其中可膨胀环处于叠套结构(从而可膨胀环的一部分弯回并进入其自身内)，且可膨胀环处于部分膨胀的结构下。
如图21所示，本发明的附加特征具有这样的内导管控制元件41，该内导管控制元件41具有用于输送和注射生物材料的多个远侧孔42，该特征可与本发明实施方式一起使用。具有孔42的内导管控制元件41包括具有中央腔的管状结构，该中央腔从外导管元件12的近端17开始，与远端13中的侧孔连通。内导管或控制元件的近端可装配有喷射装置(例如，注射器)。内导管控制元件41容纳在膨胀了的可膨胀环58的连续内腔室中。内导管控制元件41中的孔42设计成仅仅位于连续的内腔室中。另外，预期这些孔沿着内导管控制元件的长度可以具有不同尺寸，从而使生物相容性材料的输送均等化(例如，在远端的孔较大，在近端的孔较小)。此外，预期这些孔可具有不同构造，例如椭圆形，或者可以是多个槽或其它类似开口。
图22是可以与几个实施方式11、44、60、62一起使用的本发明的另一特征，由此可膨胀内环的远端上的非永久锁定元件30接合至可膨胀外环的远端26。所述锁定元件是编织物或环的一端的延伸部分，这些延伸部分与编织物或环图案互锁。所述锁定元件用于在膨胀后保持可膨胀环的期望直径。
在临床使用的一种方法中，在先通过前侧、后侧或后外侧手术径路的去除技术摘除受损的椎间盘的髓核。在外导管元件12或鞘18内的处于其被压缩构造下的可膨胀环的纤维环修复或置换装置10通过预先放入椎间空间中的进入管或套管前进。该套管可以从对本领域技术人员公知的后侧、后外侧或前侧径路进入椎间空间。然后本发明10通过进入管38前进至椎间空间中。一旦远侧可膨胀环24通过进入管38前进至椎间空间中，它就通过内导管控制元件19按前述方式缩回或前进而径向膨胀。远侧可膨胀环25膨胀至原本纤维环的其余部分的内部的极限，并保持径向膨胀和横向收缩，如图6所示。然后可以或者经由传统手术径路的直接观察或者从通过基孔的后外侧径路或后侧径路经由内窥镜将任意数量的前述人工髓核假体(puposi)放置在径向膨胀了的可膨胀环48的中央。然后该人工髓核可以或者通过吸收液体膨胀(如在基于水凝胶装置的情况中的那样)，或者通过将材料注射到髓核假体而膨胀。
一旦髓核置换物处于适当位置，在髓核置换物与可膨胀环纤维环置换装置之间的其余空间就可能由于可膨胀环装置形成的环形的内周的中央收缩而被减少或者消除。这是通过前述方式而实现的，即，通过拉回内导管控制元件，从而导致装置的内周收缩直到其抵靠髓核置换物。可膨胀的编织环48的编织设计将允许其挠曲和弯曲以适应于椎间空间。通过如前所述正确地选择构成可膨胀的编织环的材料，并正确地选择用于其制造的编织设计，该可膨胀的编织环此时将用作人工髓核的完全周向支撑件。可膨胀的编织环将防止人工髓核通过其余的原本纤维环的缺口而突出，并且用于在脊椎的弯曲和运动期间并在整个康复过程中稳定人工髓核。可膨胀环的编织设计还使其可以在中央髓核置换物膨胀并胀大至其最终尺寸时柔性弯曲。可膨胀环的编织设计还允许组织在康复时向内生长(in growth)。这可以稳定人工髓核。
在一种可选的方法中，一旦可膨胀的编织环48已经膨胀而填充人工髓核与原本椎骨和其余的原本纤维环纤维变性之间的椎间空间，可膨胀环48可填充上适当的生物相容性材料。如果如图11所示内导管控制元件19包括中央腔和与可膨胀的编织环的内腔室连接的开口，则该适当的材料可通过内导管控制元件19直接注射。或者，可利用可沿着内导管控制元件前进至可膨胀的编织环的内腔室中的单独导管元件注射生物相容性材料。或者，生物相容性材料可利用一旦可膨胀的编织环膨胀并处于椎间空间中的适当位置就刺穿该编织环的侧面的单独导管或注射针而注射到可膨胀的编织环的内腔室。可注射的生物相容性材料包括生物相容粘弹性材料，例如亲水聚合物、水凝胶、均聚物水凝胶、共聚物水凝胶、多聚物水凝胶、或互穿水凝胶、丙烯腈、丙烯酸、丙烯酰亚胺(acrylimide)、丙烯脒(acrylimidine)、包括但不限于PVA、PVP、PHEMA、PNVP，聚丙烯酰胺(polyacrylainide)、聚(环氧乙烷)、聚乙烯醇、聚丙烯腈和聚乙烯吡咯烷酮、硅酮、聚氨酯、聚碳酸酯-聚氨酯(例如Corethane)、其它生物相容性聚合物，或者它们的组合。注射的流体的粘性必须使它们可以通过导管或针注射到编织的可膨胀环中。注射的生物相容性材料必须在可膨胀的编织环内以及椎间盘空间内原位固化或聚合。生物相容性材料的该原位固化可以是多种成分的混合并聚合、从室温变到体温或升高到体温的温度变化、或者施加到注射材料的诸如光或电等其它形式的能量而产生的结果。
此外，可被引导放入可膨胀环48中并可以通过吸收诸如水等液体而膨胀的适当材料包括但不限于胀大性水凝胶材料(例如聚丙烯酰胺、聚丙烯腈、聚乙烯醇或其它生物相容性水凝胶)。用于固体或半固体部件的适当材料的实施例包括固体纤维性胶原质或其它适当的生物相容性硬质亲水材料。这些材料的胀大可导致可膨胀的编织环的进一步膨胀并导致椎间盘高度的增加。
在一些情况下，可采用多相系统，例如，可使用固体、流体或凝胶体的组合。这些材料可在编织的可膨胀环内以及椎间盘空间内产生一次水平和二次水平的柔性。
一旦可膨胀环48填充了适当的材料并且所述材料凝固或部分聚合，就可通过将内导管控制元件或细丝19与外导管元件12的接合点的远端连接部或者在其在编织的可膨胀环内的终点处移除并将内导管控制元件拉出可膨胀环而抽出内导管控制元件或细丝19。或者，可在内导管控制元件19进入可膨胀环的入口点处切断或断开内导管控制元件19。这样形成了由处于适当位置的可膨胀环形成的没有缺口的完整环形，以用作可围绕或可不围绕人工髓核装置的纤维环加固物或置换物。
在另一种临床使用方法中，在编织的可膨胀环48已经膨胀到其最大径向尺寸并用作受损的原本纤维环的加固物或置换物之后，所述装置可如前所述向中央周向收缩，从而填充原本纤维环在髓核摘除手术之前占据的任何剩余的空间。编织的可膨胀环48膨胀至其余椎间盘空间和其余的原本髓核和纤维环的极限，并且保持径向膨胀和向中央周向收缩。此时，编织的可膨胀环区域可填充生物材料或任何适当的材料(如上所述)，因为本发明在这方面不加以限制。除了所公开的用于纤维环置换物的材料之外，另外的用于髓核和纤维环置换的适当流体材料包括但不限于各种药物(类固醇、抗生素、组织坏死因子α或其拮抗剂、止痛剂)；溶液中的生长因子、基因或基因载体；生物材料(透明质酸、非交联胶原质、纤维蛋白、液体脂肪或油)；合成聚合物(聚乙二醇、液体聚硅氧烷(liquidsilicones)、合成油)；以及盐水。
一旦可膨胀环在中央和周向收缩的髓核区和纤维环区中填充有适当的材料，就可通过将内导管控制元件19与外导管元件12的接合点的远端连接部移除并将内导管控制元件拉出可膨胀环而抽出内导管控制元件19。或者，可将内导管控制元件或细丝19在其移除之前从其与远侧编织的内可膨胀环的附接部处断开。或者，可利用手术工具在内导管控制元件或细丝19进入可膨胀环的外部的入口点处切断内导管控制元件或细丝19。这样形成了由处于适当位置的可膨胀环形成的没有缺口的完整环形，以用作纤维环和髓核的加固物或置换物。
在另一种临床使用方法中，一旦已经进行髓核摘除手术就可使本发明前进至椎间空间中。一旦编织的可膨胀环24前进至椎间空间中，它就按前述方式径向膨胀。编织的可膨胀环25膨胀至原本纤维环的其余部分的外部的极限，并保持径向膨胀和横向收缩。此时，编织的可膨胀环48可填充任何适当的生物材料，例如如上所述的那些生物材料，因为本发明在这方面不加以限制。该注射材料可在一定程度上凝固或聚合，然后可膨胀环的中央部分按前述方式周向收缩。此时，椎间空间的中央髓核区填充有膨胀网。然后该中央部分可填充生物材料或任何适当的材料，例如如上所述的那些材料，因为本发明在这方面不加以限制。除了所公开的用于纤维环修复或置换的材料之外，另外的用于髓核置换的适当流体材料包括但不限于各种药物(类固醇、抗生素、组织坏死因子α或其拮抗剂、止痛剂)；溶液中的生长因子、基因或基因载体；生物材料(透明质酸、非交联胶原质、纤维蛋白、液体脂肪或油)；合成聚合物(聚乙二醇、液体聚硅氧烷、合成油)；以及盐水。
一旦编织的可膨胀环在髓核区中填充适当的材料，就可通过将内导管控制元件19与外导管元件12的接合点的远端连接部或其与远侧内可膨胀环的远端连接部移除并将内导管控制元件19拉出可膨胀环而将内导管控制元件19抽出。或者，可利用手术工具在内导管控制元件或细丝19进入可膨胀环的入口点处切断内导管控制元件或细丝19。这样形成了由处于适当位置的可膨胀环形成的没有缺口的完整环形，以用作纤维环加固物或置换物以及/或者髓核加固物或置换物。还允许装置在周边上的纤维环区和装置在中央区域中的髓核部分根据注射到各个区域中的不同的生物相容性材料而具有不同的物理性质。
在另一种临床使用方法中，一旦已经移除椎间盘的髓核，就可使本发明10前进至椎间空间中。编织的可膨胀环24按前述方式径向膨胀。远侧内部的编织的可膨胀环25被拉出可膨胀外环并且整个可膨胀环径向膨胀至原本纤维环的内部的极限。接着，将内导管控制元件19拉回至膨胀了的可膨胀环之外，并将内导管或细丝19的内部拉入可膨胀环的内周，从而使中央孔变小，并且编织的可膨胀环48横向变宽以更好地填充椎间空间中的中央缺口。该膨胀了的编织的可膨胀环48可用于与预先放在编织的可膨胀环的中部的中央假体髓核接触。在不期望另外的髓核假体的情况下，可看到编织的可膨胀环的中央部分膨胀至在环形中基本没有留下中央孔37的程度。此时，完全膨胀了的编织的可膨胀环可注射有适当的生物相容性材料(如上所述)，该材料会如前所述在原位膨胀或凝固。在这种情况下，本发明将用作假体纤维环以及假体髓核，其载荷承载特性将取决于为填充可膨胀环所选的聚合物的特性。
此外，水凝胶、聚合物或生物相容性材料可注射到可膨胀环的内腔室中，使得生物相容性材料具有由于吸收水或液体而胀大或增大尺寸的能力。这可以导致可膨胀的编织环进一步膨胀以及椎间盘高度的增加。
在另一种临床使用方法中，要进行的治疗是利用本发明10熔合两个相邻的椎骨。再次利用图10的图示，内导管控制元件19的端部附接到编织的可膨胀环24的内部和远端22。为了使可膨胀环的直径膨胀，只需要稳定编织的可膨胀环的近侧部分或外端23，并将内导管控制元件或细丝19或丝线拉回即可。这会导致在丝线缩回时编织的可膨胀环的内部拉出编织的可膨胀环的外部。一旦编织的可膨胀环48达到了期望的外径，就可通过将相同的内导管控制元件19进一步拉回至编织的可膨胀环的近侧部分之外而接触编织的可膨胀环48的中央部分。内导管控制元件或细丝19的内环部的直径将收缩，并且继续拉动编织的可膨胀环48的内周，从而导致环形的中央“孔”的直径37越变越小。这导致环形的横向直径变大而外径保持不变。一旦达到期望的尺寸，丝线就可保持在适当位置，并且可将如上所述的聚合材料或其它生物相容性材料注射到环形中，该注射是或者通过内导管控制元件(其可呈中空导管或海波管的形式)、或者经由沿着内导管控制元件或细丝19前进至环形中的导管、或者单独使用用于注射的导管或针而进行的。此时，完全膨胀了的可膨胀环48可注射或填充用于将两个相邻椎骨熔合在一起的适当材料。适当的熔合材料的候选包括但不限于骨移植物材料，例如记述为“骨接合剂”的任何材料或任何聚合骨移植物化合物、骨移植物材料、尼龙纤维、碳纤维、玻璃纤维、胶原质纤维、陶瓷纤维、聚乙烯纤维、聚(对苯二甲酸乙二酯)、聚乙交酯、聚丙交酯及其组合。
一旦已经注射了骨熔合材料，就可通过将内导管控制元件19从编织的可膨胀环缩回而移除内导管控制元件19。或者，可在内导管控制元件19进入环形的入口点处切断内导管控制元件19。在另一实施方式(未示出)中，可利用刚度足够的内细丝(例如所述金属丝)而使可膨胀环的直径膨胀，并且可通过继续拉动附接到编织的可膨胀环的内径上的单独的柔性细丝(例如纱线)而使中央孔变小。
在将两个相邻椎骨熔合在一起的该实施方式中，理想的是通过填充材料刺激骨头的生长。为了有利于骨结合和生长，可膨胀环应具有渗透性更大的开口。可膨胀环的孔或开口直径为约0.25mm到约5.0mm。尺寸选择为允许组织向内生长，同时容纳装入可膨胀环的材料。而且还设想在体外将造骨细胞、例如成骨细胞，以及或者生长因子接种入可膨胀环中。所施加的多层接种成骨细胞可以上下叠置，从而进一步允许或促进增生。除了体外接种成骨细胞外，还设想到对编织的可膨胀环采用其它处理，这些处理也提供允许骨向内生长和骨组织再生的移植。例如，可膨胀环可涂覆有脱钙骨基质或涂布或涂覆诱骨骨膏，例如OSTEOFILTM。此外，可膨胀环可涂覆有胶原质，随后浸泡在药物试剂中，这些试剂例如为重组人骨形态发生蛋白、抗生素试剂或其它类似材料。
应理解，本发明的前述说明仅仅用于对其进行例示，并且本发明的其它实施方式、修改和等同物在所附权利要求所述的本发明范围内。另外，虽然上述各个实施方式包括一定特征，但本发明在该方面不加以限制。因此，可单独或以任意适当的组合来实施本发明的一个或多个上述特征或其它特征、生物材料的输送方法或注射方法，因为本发明不限于
具体实施方式。

Claims (24)

1、一种用于人工椎间盘置换的方法，所述方法包括：
引导含有生物相容性溶剂和生物相容性聚合物的第一溶液进入椎间空间中的步骤和引导第二溶液进入椎间空间中的第二步骤，由此，在椎间空间内形成半固体或固体介质以取代纤维环、髓核或纤维环和髓核。
2、如权利要求1所述的方法，其中，引导所述第二溶液包括以下步骤：使所述生物相容性聚合物从所述第一溶液中析出，以使所述生物相容性聚合物在所述椎间空间凝固并使所述生物相容性溶剂分散到身体组织中。
3、如权利要求1所述的方法，其中，所述第一溶液包含至少在哺乳动物的体温下能够在其中溶解所述生物相容性聚合物的液体材料。
4、如权利要求3所述的方法，其中，所述液体材料由从包括以下材料的组中选择的材料形成：二甲亚砜、二甲亚砜的类似物/同系物、乙醇、乳酸乙酯、丙酮或其组合。
5、如权利要求1所述的方法，其中，一种或更多种所述生物相容性聚合物从包括以下材料的组中选择的材料形成：亲水聚合物、水凝胶、均聚物水凝胶、共聚物水凝胶、多聚物水凝胶、或互穿水凝胶、丙烯腈、丙烯酸、丙烯酰亚胺、丙烯脒，包括但不限于PVA、PVP、PHEMA、PNVP，聚丙烯酰胺、聚(环氧乙烷)、聚乙烯醇、聚丙烯腈和聚乙烯吡咯烷酮、硅酮、聚氨酯、聚碳酸酯-聚氨酯(例如Corethane)、其它生物相容性聚合物，或者它们的组合。
6、如权利要求1所述的方法，其中，所述第二溶液由从水和盐溶液或它们的组合组成的组中选择的溶剂形成。
7、一种用于人工椎间盘置换的方法，所述方法包括：
引导含有生物相容性溶剂和生物相容性聚合物的溶液进入椎间空间的步骤，由此使体液取代所述溶剂，并且在所述椎间空间内形成半固体或固体介质以取代纤维环、髓核或纤维环和髓核。
8、如权利要求7所述的方法，其中，所述体液使所述生物相容性聚合物从所述溶液中析出，以使所述生物相容性聚合物在所述椎间空间凝固并使所述生物相容性溶剂分散到身体组织中。
9、如权利要求7所述的方法，其中，所述溶液包含至少在动物体温下能够在其中溶解所述生物相容性聚合物的液体材料。
10、如权利要求9所述的方法，其中，所述液体材料由从二甲亚砜、二甲亚砜的类似物/同系物、乙醇、乳酸乙酯、丙酮或者它们的组合组成的组中选择的材料形成。
11、如权利要求7所述的方法，其中，一个或多个所述生物相容性聚合物从包括以下材料的组中选择的材料形成：亲水聚合物、水凝胶、均聚物水凝胶、共聚物水凝胶、多聚物水凝胶、或互穿水凝胶、丙烯腈、丙烯酸、丙烯酰亚胺、丙烯脒，包括但不限于PVA、PVP、PHEMA、PNVP，聚丙烯酰胺、聚(环氧乙烷)、聚乙烯醇、聚丙烯腈和聚乙烯吡咯烷酮、硅酮、聚氨酯、聚碳酸酯-聚氨酯(例如Corethane)、其它生物相容性聚合物，或者它们的组合。
12、如权利要求7所述的方法，其中，所述体液由从水和盐溶液或它们的组合组成的组中选择的溶剂形成。
13、一种用于人工椎间盘置换的方法，所述方法包括：
在位于椎间空间内的柔性可膨胀的可膨胀环内分配含有生物相容性溶剂和生物相容性聚合物的第一溶液的步骤，和引导第二溶液进入所述椎间空间的第二步骤，由此，在所述椎间空间内形成半固体或固体介质以取代纤维环、髓核或纤维环和髓核。
14、如权利要求13所述的方法，其中，引导所述第二溶液包括以下步骤：使所述生物相容性聚合物从所述第一溶液中析出，以使所述生物相容性聚合物在所述椎间空间凝固并使所述生物相容性溶剂分散到身体组织中。
15、如权利要求13所述的方法，其中，所述溶液包含至少在动物体温下能够在其中溶解所述生物相容性聚合物的液体材料。
16、如权利要求15所述的方法，其中，所述液体材料由从二甲亚砜、二甲亚砜的类似物/同系物、乙醇、乳酸乙酯、丙酮或者它们的组合组成的组中选择的材料形成。
17、如权利要求13所述的方法，其中，一个或多个所述生物相容性聚合物从包括以下材料的组中选择的材料形成：亲水聚合物、水凝胶、均聚物水凝胶、共聚物水凝胶、多聚物水凝胶、或互穿水凝胶、丙烯腈、丙烯酸、丙烯酰亚胺、丙烯脒，包括但不限于PVA、PVP、PHEMA、PNVP，聚丙烯酰胺、聚(环氧乙烷)、聚乙烯醇、聚丙烯腈和聚乙烯吡咯烷酮、硅酮、聚氨酯、聚碳酸酯-聚氨酯(例如Corethane)、其它生物相容性聚合物，或者它们的组合。
18、如权利要求13所述的方法，其中，所述第二溶液由从水和盐溶液或它们的组合组成的组中选择的溶剂形成。
19、一种用于人工椎间盘置换的方法，所述方法包括：
在位于椎间空间内的柔性可膨胀的可膨胀环内分配含有生物相容性溶剂和生物相容性聚合物的溶液的步骤，由此使体液取代溶剂，并且在所述椎间空间内形成非生物相容性半固体或固体介质以取代纤维环、髓核或纤维环和髓核。
20、如权利要求19所述的方法，其中，引导所述体液而使所述生物相容性聚合物从所述溶液中析出，以使所述生物相容性聚合物在所述椎间空间凝固并使所述生物相容性溶剂分散到身体组织中。
21、如权利要求19所述的方法，其中，所述溶液包含至少在动物体温下能够在其中溶解所述生物相容性聚合物的液体材料。
22、如权利要求21所述的方法，其中，所述液体材料由从二甲亚砜、二甲亚砜的类似物/同系物、乙醇、乳酸乙酯、丙酮或者它们的组合组成的组中选择的材料形成。
23、如权利要求19所述的方法，其中，一个或多个所述生物相容性聚合物从包括以下材料的组中选择的材料形成：亲水聚合物、水凝胶、均聚物水凝胶、共聚物水凝胶、多聚物水凝胶、或互穿水凝胶、丙烯腈、丙烯酸、丙烯酰亚胺、丙烯脒，包括但不限于PVA、PVP、PHEMA、PNVP，聚丙烯酰胺、聚(环氧乙烷)、聚乙烯醇、聚丙烯腈和聚乙烯吡咯烷酮、硅酮、聚氨酯、聚碳酸酯-聚氨酯(例如Corethane)、其它生物相容性聚合物，或者它们的组合。
24、如权利要求19所述的方法，其中，所述体液由从水和盐溶液或它们的组合组成的组中选择的溶剂形成。
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WO2007055755A1 (en) 2007-05-18
CN101296670A (zh) 2008-10-29
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CA2632189C (en) 2012-04-24
AU2006312259A1 (en) 2007-05-18
EP1948094A4 (en) 2011-06-22
US20060287729A1 (en) 2006-12-21
AU2006312261A1 (en) 2007-05-18
CN101374472A (zh) 2009-02-25
EP1948059A1 (en) 2008-07-30
US7601172B2 (en) 2009-10-13
CA2629399A1 (en) 2007-05-18
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AU2006317686A1 (en) 2007-05-31
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