CN1812756A - 椎间盘植入体及其制造和使用方法 - Google Patents

椎间盘植入体及其制造和使用方法 Download PDF

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CN1812756A
CN1812756A CNA2004800180973A CN200480018097A CN1812756A CN 1812756 A CN1812756 A CN 1812756A CN A2004800180973 A CNA2004800180973 A CN A2004800180973A CN 200480018097 A CN200480018097 A CN 200480018097A CN 1812756 A CN1812756 A CN 1812756A
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implant
intervertebral disc
superelastic
elastomeric polymer
hydrogel
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M·C·舍曼
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Warsaw Orthopedic Inc
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SDGI Holdings Inc
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Abstract

描述的椎间盘植入体(11)包括一种弹性聚合体(12)，尤其是水凝胶体，和一种超级弹性元件(13)。还描述了制造和使用这种植入体的方法。

Description

椎间盘植入体及其制造和使用方法
背景
本发明一般涉及椎间盘植入体，具体涉及一种在弹性体内具有内部芯元件的椎间盘植入体。
作为进一步的背景，曾经考虑过许多植入脊柱盘空间的装置。这些装置多数使用弹性材料，例如水凝胶。这种装置还采用基本上为线形的构造以通过椎间盘环内的小孔植入，并在植入盘空间后立即具有第二种不同的构造。
这种装置的一个显著问题是，它们无法在植入盘空间后有效转变成所需构造。此外，在变为所需构造后，该装置必需经得起脊柱内通常会遇到的重复加载的问题。本发明的一些方面就是为了满足椎间盘植入体的这些要求及其它要求中的一个或多个。
发明概述
因此，一方面，本发明提供了一种含有水凝胶或其它类似弹性聚合体并在所述弹性体内具有由一种超级弹性材料构成的元件的椎间盘植入体。在某些形式下，这种植入体具有其中嵌入拉长的超级弹性金属元件的拉长的水凝胶体。所述超级弹性元件基本上沿拉长的水凝胶体的全长延伸。在一具体实施方案中，所述植入体包含拉长的水凝胶体以及由一种超级弹性镍-钛合金构成的拉长的芯元件。在这种植入体中，水凝胶体和芯元件的松弛构造为螺旋构造。
在另一方面，本发明提供了一种在患者体内提供椎间盘植入体的方法。所述方法包括打开患者的椎间盘环，并通过该开口将椎间盘植入体引入由椎间盘环确定的空间。所述盘植入体包括一种大小为能引入盘空间的弹性聚合体和所述弹性体内的超级弹性元件。在某些形式下，这种方法包括使植入体保持第一引入构造，通过椎间盘环上的开口插入植入体，并使植入体在植入空间变为不同于第一构造的第二构造。
再在另一方面，本发明提供了一种制造椎间盘植入体的方法。该方法包括提供一种超级弹性元件，并在所述元件周围提供水凝胶或其它类似弹性体。这些方法的具体实施方案包括这里所述的椎间盘植入体的制造方法。
附图简述
图1是本发明椎间植入体的透视图。
图2是处于伸直构造的图1的植入体的透视图。
图3A和3B是图1和图2的植入体的截面图，分别为非膨胀状态和膨胀状态。
图4-6图解了引入本发明的椎间植入体的步骤。
发明详述
为了加深对本发明原理的理解，下面将结合特定的优选实施方式进行介绍，叙述时将使用具体的语汇。但应当理解，这些实施方式不对本发明的范围构成任何限制，本发明所涉领域的技术人员不难想到所述优选实施方式的替代形式和其他改进形式。
如上所述，本发明提供了一种椎间盘植入体装置以及它们的制造和使用方法。更具体的例子有螺旋形椎间植入体。
在本发明的某些方面，所述椎间植入体的主体可由水凝胶或其它合适的弹性材料形成。可使用水溶性材料，这样在植入盘空间后植入体的体积会增加。
适合用于本发明的水凝胶材料包括轻度交联的生物相容性亲水单体的均聚物和共聚物，如丙烯酸2-羟基烷基酯类和甲基丙烯酸2-羟基烷基酯类，例如甲基丙烯酸2-羟乙酯(HEMA)；N-乙烯单体，例如N-乙烯-2-吡咯烷酮(N-VP)；不饱和烯酸，例如甲基丙烯酸(MA)和不饱和烯式碱，例如甲基丙烯酸2-(二乙基氨基)乙酯(DEAEMA)。共聚物中还可包含非亲水单体残基，如甲基丙烯酸烷基酯，例如甲基丙烯酸甲酯(MMA)等等。交联共聚物可用已知方法，在存在交联剂(如乙二醇二甲基丙烯酸酯和亚甲基双(丙烯酰胺))和引发剂(如2，2-偶氮二(异丁腈)、过氧化苯甲酰等)以及辐射(如UV和γ射线)时形成。
制备这些聚合物和共聚物的方法是本领域熟知的。这些水凝胶的EWC是可变的，例如，在室温条件下从PolymaconTM(聚HEMA)的38％到LidofilconTM B(N-VP和MMA的一种共聚物)的约79％。
可用于本发明实践的其它水凝胶类型有HYPANTM和聚(乙烯醇)(PVA)水凝胶。这些水凝胶不同于上述水凝胶，是不交联的。它们在水性介质中不溶是由于它们的部分结晶结构。HYPANTM是一种部分水解的聚丙烯腈。有一种多嵌段共聚物(MBC)，其中包含使水凝胶具有良好的机械特性的硬的结晶腈嵌段以及为水凝胶提供良好水结合能力的软的无定形亲水嵌段。制造具有不同含水量和机械特性的HYPANTM水凝胶的方法已揭示于美国专利4,337,327；4,370,451；4,331,783；4,369,294；4,420,589；4,379,874和4,631,188。用于本发明的这种材料的前核形式可通过熔化处理(使用DMF和DMSO等溶剂作为助熔剂)或通过溶解处理来制备。
在本发明的实践中有用的一种具体的水凝胶类型是高度水解的结晶聚(乙烯醇)(PVA)。水解的量可在95％和100％之间，取决于所需EWC，EWC将在约60％和90％之间。通常，最终的水凝胶的含水量将随着起始PVA水解的降低而升高，这将导致结晶性降低。
可从市售的PVA粉末用本领域已知的任何方法制备部分结晶的PVA水凝胶。例如，它们可用美国专利4,663,358中揭示的方法制备，该方法被纳入本文作为参考。在工业上，可将10-15％的PVA粉末与溶剂(如水、二甲基亚砜(DMSO)、乙二醇或其混合物)混合。然后将混合物加热至约100-120℃，直到形成粘性溶液。然后将该溶液倒入或注射入管状的金属、玻璃或塑料模具并使其冷却至-10℃以下，优选冷却至约-20℃。
使溶液在该温度下保持数小时，期间会发生结晶，因此发生PVA的凝胶作用。成形的凝胶用几份水浸泡至少2天，水需要定期更换，直到凝胶中所有的有机溶剂被水替代。然后使含水凝胶部分或完全干燥以植入。在与天然椎间盘核相同的条件下，这样制得的水凝胶的EWC为60-90％，且压缩强度至少为1MNm-2，优选约4MNm-2。
可用已知方法确定溶剂交换是否完成。例如，当溶剂是DMSO时，其从凝胶中除去可用以下方法确定：在50mL从凝胶分离的等分水中加入50μL 0.01N KMnO4溶液。KMnO4出现特有粉红色将说明存在DMSO。当DMSO被完全除去后粉红色将消失。当将空白与0.3ppm DMSO标准水溶液对照时，该方法的检出限为0.3ppm DMSO。
通常可使用任何可用于生物医学目的的水凝胶。在本发明的某些形式下，在与椎间盘的核和终板(end plate)相同的条件下，这种水凝胶的EWC约为30-90％，且压缩强度至少约为1MNm-2，优选4MNm-2。从这些材料形成脱水形式(干凝胶)的例如杆状或管状植入体可通过模塑或车床切割来制造。在模塑时，含有引发剂的液态单体混合物被倒入具有预定形状和大小的模具中，并固化。如果有必要，浇铸混合物中可含有水或其它含水介质。在那些条件下，所得成形的物体将是部分水合的，即水凝胶。在车床切割时，可用上述类似的方法制备块状或棒状的干凝胶，其尺寸大于需要形成假核的尺寸。干凝胶然后被切割成植入盘空腔所需的形状和大小。这两种情况下，由于聚合物遇水溶胀，在设计模具或在切割成块状、棒状或管状时需要考虑水凝胶的膨胀因子。
本发明的某些实施方案提供了含有由超级弹性材料构成的内部元件或芯元件的植入体。在一种示例性的实施例中，这种植入体可通过在超级弹性元件周围模压或浇铸弹性(例如水凝胶)聚合物体来制备。
已知超级弹性材料具有不寻常的弹性和柔性。这些材料通常还具有形状记忆效应。当在一种温度下从原始形状发生弹性形变时，这种材料将在较高温度下恢复它们原来的形状。
还已知超级弹性材料可发生相变，这被称为马氏体相变，其中，它们从一种被称为奥氏体的高温形式变为被称为马氏体的低温形式。对于一种给定的超级弹性合金，马氏体和奥氏体之间的相变发生在被称为相变温度的可预测的温度下。
至于这些温度依赖特性，为显示形状记忆效应，超级弹性合金结构必需首先在室温下弯曲成要“被记忆”的形状。然后加热该合金元件直到它出现被称为β相或母相(parent phase)的高温构造。在该相中，金属的晶体结构呈现其将“回忆”的奥氏体形式。然后，迅速冷却合金，这样合金中的原子就会自己重排成马氏体的晶体形式。然后将合金弯曲成将它在相变温度下一直保持的新的形状。随后加热该元件至其相变温度以上，这样合金的结构将变为奥氏体形式，从而使元件恢复其预先记忆的形状。
可用超级弹性材料的这种形状基因特性来制造本发明的椎间植入体。例如，可利用超级弹性元件的形状记忆特性以便于椎间盘植入体从引入时的第一构造转变为引入及温度达到患者体温后的第二构造。或者或此外，这些温度依赖性形状记忆特性可在处于其第二植入构造的植入体内提供一种余力以使植入体稳定在这种构造。
工业上，可使用相变温度在一个相对较低的温度(植入体将在此温度下被引入)和一个较高温度(患者体温)之间的超级弹性材料。超级弹性元件(例如的拉长线形元件或类似元件)可形成第二植入构造(例如螺旋形)，并加热直至其晶体结构呈现其“被记忆的”奥氏体形式。然后冷却以形成马氏体晶体形式，此时可将超级弹性元件拉直，然后在超级弹性元件周围提供弹性体，如通过在元件周围模压或铸造水凝胶体。因此，在引入后，超级弹性元件将由患者体温被加热至其相变温度以上，因此转变为其第二植入构造。应该理解，在这点上，这种形状记忆效应可与超级弹性温度依赖特性结合，以利于第一和第二构造之间的转变。
在另一个示例性的实施方案中，使用具有上述中间相变温度的超级弹性材料，这种超级弹性元件可用来进一步稳定植入体处于其第二植入构造。例如，对于例如螺旋形或折叠形的植入构造，其中，植入体的两个部分将相互接触，超级弹性元件的形状记忆特性可强制维持这种接触，从而稳定最终的构造。
在一个具体的示例性实施方案中，可使拉长的超级弹性元件形成比较紧或比最终植入构造更加紧的螺旋，然后加热以记忆这种形式，并冷却。然后可将这种螺旋形元件弯曲成接近植入构造要求的不太紧密的形式，再在螺旋元件周围提供(例如模压或铸造)拉长的水凝胶体。为了引入，螺旋形植入体可被强制拉直。引入后，植入体将松弛成为其部分相互接触的植入构造，然后超级弹性元件将由患者体温加热至其相变温度以上，这样就提供了一种持续的余力以维持植入体内的接触点。
如上所述，超级弹性材料也具有有益的温度依赖特性。相对与非超级弹性材料，超级弹性合金具有显著增加的弹性，这是由于记忆金属的原子在马氏体和奥氏体形式之间来回迁移，并且不会像普通金属那样形成新的构造。在具有能够在应力下制造马氏体的β相的合金中，观案到了一种被称为超级弹性的不寻常的弹性特性。具有这种特性的代表性合金在应力下显示正常的弹性行为，直到达到临界应力，在临界点上，马氏体峰值结构开始形成。当应力继续增加时，元件像物理形变那样继续伸长。当应力被去除后，马氏体结构转变为母相或奥氏体结构，同时金属收缩到原始长度，显示几乎没有永久形变。
在一个具体实施方案中，所述超级弹性材料可以是镍-钛合金，如市售的Nitinol。
现在参考图1，它显示了本发明的一个椎间盘植入体的透视图。植入体11包括由聚合材料尤其是水凝胶制成的弹性体12。埋入弹性体12的是由超级弹性元件如超级弹性镍-钛合金制成的芯元件元件13。植入体11的高度H和宽度W适合植入由椎间盘环确定的盘空间内。
现在参考图2，它显示了线形或拉直构造的图1的植入体11。如图所示，弹性体12和超级弹性芯元件13为相对线形构造，使得该装置为易于通过插管并进入盘空间的状态。
参考图3A和3B，该图显示了图2的装置的截面图。在图3中，植入体12由脱水或仅部分水合的水凝胶形成，因此具有相对较小的界面直径。图4显示的是水合程度较高或完全水合形式的相同的植入体12，因此具有较低的界面直径。可以理解，图3所示的完全或部分脱水的植入体将更加容易通过较小的插管和椎间盘环上较小的开口，以输送到盘空间。因此，植入体11吸水并膨胀成较大的尺寸。
参考图4-6，这些图一般显示的是理解本发明一个过程的步骤。在第一个步骤中，在椎间盘环20上提供一个或多个进入内部盘空间21的开口。可通过切割或分割装置如解剖刀来提供这些开口。此外，应该理解，可在一个或多个开口上提供入口插管(assess cannula)，如组织收缩插管，通过这种插管可操作这里所述的其它手术器械。
组织断裂装置22被用来从盘空间21内断裂核组织，该组织可任选通过真空吸出。通过开口25伸入椎间盘环20的内窥镜23或其它可视化装置可用来显现盘空间。参考图5，除去盘空间21的物质之后，通过开口24插入引入插管26，使植入体11通过插管26并将其输送到盘空间21。现在参考图6，该图显示了处于通常为卷曲或螺旋形状的植入构造的植入体11。引入植入体11后，可取出输送插管26，同时也可除去内窥镜23以及手术中使用的任何入口插管。如果需要的话，可用合适的材料修补或缝合环20上的开口24和25。
在本发明的一个实施方案中，植入体11与至少一种用于这种盘外科手术的其它装置，如输送插管26、可视化装置23、组织断裂装置22、入口插管等，一起提供在套件或系统中。所有这些装置和/或其它装置的任何组合以及植入体11可被装入本发明的外科手术套件或系统中。
此外，本发明的植入体可有一种或多种具有任何形状或构造的植入体主体。在一些具体的实例中，超级弹性芯元件，例如对应于这里所述的芯元件13，可被掺入SDGI控股股份有限公司(SDGI Holding Inc.)于2003年9月16日提交的第6,620,196号美国专利中所述的植入体主体和形状，并可被修改以便于植入体转变为所需植入构造和/或使植入体稳定在这种构造。
前面的附图和说明书已经对本发明作出了阐释，但应当理解这些附图和叙述仅仅出于说明的目的，不对本发明特征构成限制。应当理解，所展示和介绍的仅仅是优选实施方式，在本发明主旨范围之内的所有变化形式和改进形式都在本发明保护范围之内。

Claims (25)

1.一种椎间盘植入体，它包括：
一种大小为能引入盘空间的弹性聚合体；和
一种在所述弹性体内的超级弹性元件。
2.如权利要求1所述的椎间盘植入体，其特征在于，所述弹性聚合体是水可膨胀的。
3.如权利要求2所述的椎间盘植入体，其特征在于，所述弹性聚合体包括水凝胶。
4.如权利要求1-3中任一项所述的椎间盘植入体，其特征在于，所述超级弹性元件包括超级弹性金属合金。
5.如权利要求4所述的椎间盘植入体，其特征在于，所述超级弹性金属合金是镍-钛合金。
6.如权利要求1所述的椎间盘植入体，其特征在于，所述弹性聚合体和所述超级弹性元件是拉长的。
7.如权利要求6所述的椎间盘植入体，其特征在于，所述植入体具有螺旋形松弛构造。
8.如权利要求7所述的椎间盘植入体，其特征在于，所述植入体可强制构造成一种基本上直的构造。
9.一种制造椎间盘植入体的方法，所述方法包括：
提供一种超级弹性元件；并
将所述超级弹性元件掺入一种大小为能引入椎间盘空间的弹性聚合体中。
10.如权利要求9所述的方法，其特征在于，所述弹性聚合体是水可膨胀的。
11.如权利要求10所述的方法，其特征在于，所述弹性聚合体包括水凝胶。
12.如权利要求11所述的方法，所述方法包括将水凝胶模压在所述超级弹性元件周围。
13.如权利要求9-12中任一项所述的方法，其特征在于，所述超级弹性元件包括超级弹性金属合金。
14.如权利要求13所述的方法，其特征在于，所述超级弹性金属合金是镍-钛合金。
15.如权利要求13所述的方法，其特征在于，所述植入体具有螺旋形松弛构造。
16.如权利要求13所述的方法，其特征在于，所述植入体可强制构造成一种基本上直的构造，并具有不同于所述直的构造的松弛构造。
17.一种在患者体内提供椎间盘植入体的方法，所述方法包括：
在患者的椎间盘环内提供一个开口；并
通过该开口将椎间盘植入体引入由椎间盘环确定的空间，所述盘植入体包括一种大小为能引入所述空间的弹性聚合体和所述弹性体内的超级弹性元件。
18.如权利要求17所述的方法，其特征在于，所述弹性聚合体包括水凝胶。
19.如权利要求17或18所述的方法，其特征在于，所述超级弹性元件包括超级弹性金属合金。
20.如权利要求17所述的方法，其特征在于，在所述引入过程中，所述植入体具有第一构造，且在所述引入后所述植入体具有不同于所述第一构造的第二构造。
21.如权利要求20所述的方法，其特征在于，所述第一构造是基本上直的。
22.如权利要求20所述的方法，其特征在于，所述第二构造是螺旋形的。
23.如权利要求22所述的方法，其特征在于，所述第一构造是基本上直的。
24.一种治疗椎间盘的系统，包括：
如权利要求1-8中任一项所述的椎间盘植入体；和
至少一种治疗椎间盘的其它装置。
25.如权利要求24所述的系统，其特征在于，所述其它装置包括内窥镜、组织断裂装置、组织分离装置和组织收缩插管中的一种或多种。
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