CN1697634A - 天然组织装置和移植方法 - Google Patents

天然组织装置和移植方法 Download PDF

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Publication number
CN1697634A
CN1697634A CNA038249898A CN03824989A CN1697634A CN 1697634 A CN1697634 A CN 1697634A CN A038249898 A CNA038249898 A CN A038249898A CN 03824989 A CN03824989 A CN 03824989A CN 1697634 A CN1697634 A CN 1697634A
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CN
China
Prior art keywords
implant
natural
pigtail
tissue
weaving
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Pending
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CNA038249898A
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English (en)
Inventor
W·F·麦克凯
H·H·邱
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Warsaw Orthopedic Inc
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SDGI Holdings Inc
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Publication of CN1697634A publication Critical patent/CN1697634A/zh
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Abstract

本发明提供一种关于使用天然生物组织修复或置换椎间盘或盘核的材料和方法。所述组织可以不带有附加的核心材料单独使用，或者可用于封装弹性体的或水凝胶的核心。当单独使用时，可以将该组织卷起、折叠、编成辫或层叠，用于提供天然生物材料的实心的孔塞。当用于封装弹性体的或水凝胶的核心时，该组织作为支持该核心的限制外套。天然组织植入物还可以包括拉线，当该装置被插入椎间盘空间内时有助于折叠该植入物。可以一起使用天然组织植入物的多个单元。

Description

天然组织装置和移植方法
                     相关申请的交叉参考
本申请是2002年9月18日递交的待审批的美国专利申请60/411,514、2003年8月21日递交的待审批的美国专利申请10/645,006、2003年4月25日递交的待审查的美国专利申请10/245,955和2002年11月15日递交的待审查的美国专利申请60/426,613的部分续展申请。所有上述专利申请的全部内容结合在这里供参考。
                          发明领域
本发明总体上涉及利用天然组织补充或修复矫形结构，更具体地涉及利用天然组织补充或修复例如椎间盘和/或滑膜关节的矫形结构。
                          发明背景
椎间盘的功能是稳定脊柱和分散椎骨体之间的力。正常的盘包括髓核、纤维环和两椎骨端板。纤维环包围和限制髓核。
已知椎盘易于受伤害和退化。例如，突出的盘是常见的，代表性地发生于正常磨损或异常损伤导致的盘破裂时。通常的老化过程代表性地造成退行性盘病，其中组织逐渐失去它的天然水分和弹性，引起退化的盘收缩和可能破裂。
常通过置换或补充现有的盘材料治疗椎间盘的损伤和退化。目前的椎间盘置换过程趋向于使用聚乙烯网的合成材料封装水凝胶的中央核心。将这些合成材料织造成有织纹的织物，该织物的粗糙表面可能加速被封装的水凝胶或椎间体的骨端板的磨损。由于磨损可能产生磨损微粒，这又能够造成有害的生物反应，例如在椎骨体端板骨内的骨质溶解和随后的植入物的沉降。
例如，在使用带有聚乙烯网外套的修复的核置换装置方面的报告已指出这些装置沉降进入椎间体的端板内。沉降也是由于该外套和硬的水凝胶核心的僵硬顺应性而产生。该参数与椎骨不匹配、结合上述的其它设计特征会促使植入物沉降。
除了椎间盘和关节之外，在哺乳动物附肢骨骼中也存在其它滑膜关节。代表性的滑膜关节包括由关节软骨层覆盖的两骨端。该软骨是平滑的和有弹性的，有助于关节中的诸骨的低摩擦运动。
由关节囊-一个产生滑液的薄膜“袋子”包围骨端和相关的软骨。该囊和液体保护和支持软骨和相连的组织，将营养物传送给关节软骨和去除代谢的废物。
关节软骨是在骨的骨骺上的透明的软骨薄(2-3毫米)层。它缺少软骨膜，因此当损坏时仅具有有限的修复能力。此外，自然老化过程能够引起关节软骨某些退化，降低了它保护和缓冲骨端的能力。
椎骨关节，更常称为小平面关节，是将脊柱的各椎骨连接到它之上和/或它之下的椎骨的机构。各关节包括两个小平面骨-下小平面和上小平面-由一椎骨的下小平面连接到相邻的椎骨的上小平面。关节便于椎骨相互相对运动，以及允许椎柱弯曲和扭转。
如在所有的滑膜关节内那样，在诸小平面相互接触处存在被薄层滑液润滑的软骨衬层。软骨和滑液减小在关节处的磨擦，延长关节的寿命和防止炎症和相关的疼痛。
随着自然老化过程的进展，关节的软骨覆盖层可能退化并开始磨损。磨损的过程可能引起软骨块断开，以及原来光滑表面可以变得粗糙。然后小平面骨开始相互摩擦，产生导致关节进一步恶化的摩擦。并且，与关节相关联的神经被刺激和发炎，造成严重的疼痛和脊柱运动受限制。
用于解决一般滑膜关节、尤其小平面关节的退化的技术至今主要是依靠注射，用于停止疼痛和减少炎症。不过这治疗仅仅是临时性的，很少会导致根本状况的任何显著改善。
从以上情况可知需要有椎间盘植入物，该植入物避免与在补充、修复或置换一椎间盘的全部或部分中合成材料的使用相关联的问题。还能理解到需要具有治疗退化的滑膜关节的有效材料和方法，尤其是补充或置换润滑和保护关节的软骨的有效材料和方法。本发明满足这些需求。
                           发明概要
本发明的一方面使用天然生物组织提供了关于补充、修复或置换一椎间盘的部分或全部的材料和方法。该组织可以呈条状、片状或孔塞状以及其它形状被提供，并且均可被卷起、折叠、编成辫等，以形成所需的结构。该组织可以单独使用，或者与其它天然材料或与一种第二材料结合使用。
或者，可以单独使用天然组织或与另一材料一起使用，用于补充或修复任何滑膜关节或其它解剖结构。尤其编成辫的天然组织段在多种多样的矫形应用中被使用。
从优选优选实施例的以下叙述中，本发明另外的特点和优点将变得很明显。
                         附图简要说明
图1是依据本发明的一个方面的、用作盘置换装置的一卷天然组织材料的整个截面的侧剖视图。
图2示出了依据一优选优选实施例的、本发明的天然组织植入物(naturaltissue implant)的一个“卷”实施例。
图3示出了图2所示的天然组织卷的另一实施例。
图4示出了依据一优选优选实施例的、本发明的天然组织植入物的一个“编成辫的”实施例。
图5A示出了带有拉线穿过以引起植入物集聚或合拢的、图4的编成辫植入物的透视图。
图5B示出了图5A的编成辫的植入物的另一透视图。
图6示出了在拉动所述拉线之后呈折叠状的图5的编成辫的植入物(braided implant)。
图7示出了植入一盘核内的处于它的第一伸直状态的图5的编成辫的植入物，以及该植入物。
图8示出了植入一盘核内的开始折叠的图5的编成辫的植入物。图9示出了植入一盘核内的继续折叠的图5的编成辫的植入物。
图10示出了在植入一盘核之后、处于它的第二、被折叠的状态的图5的编成辫的植入物。
图11示出了由一叠单独的组织片制成的一天然组织植入物。
图12示出了由一折叠的组织片制成的一天然组织植入物。
图13示出了由多个子单元制成的一天然组织植入物，各子单元包括一卷组织。
图14示出了图13的、诸子单元正被折叠起来以形成一较宽植入物的天然组织植入物。
图15示出了图13的、诸子单元已被折叠形成一较宽植入物的天然组织植入物。
图16示出了由多个子单元制成的天然组织植入物的又一实施例，各子单元包括一卷组织。
图17示出了图16的、诸子单元被折叠起来形成一较宽的植入物天然组织植入物。
图18示出了在一“手风琴状”实施例中由多个子单元制成的天然组织植入物。
图19示出了图18的、诸子单元折叠以形成一较窄植入物的天然组织植入物。
图20示出了图18的、诸子单元折叠以形成一较宽植入物的天然组织植入物。
图21示出了用缝线连接在一起的一叠天然组织植入物。
图22示出了用于固定一叠植入物的一保持夹。
图23示出了用于固定一叠植入物的另一保持夹。
图24示出了本发明的天然组织植入物的一“枕块状”实施例。
图25示出了图24的“枕块状”实施例的剖视图。
图26示出了本发明的天然组织植入物的另一“枕块状”实施例。
图27示出了本发明的一“袋状(pouch)”实施例，该袋处于盘核空间内和在该袋内没有组织块。
图28示出了图27的、组织块被植入所述袋内的“袋状”实施例。
图29示出了图27的、更多组织块被植入所述袋内的“袋状”实施例。
图30示出了图27的、在组织块被植入所述袋内和所述袋被封闭之后的“袋状”实施例。
图31示出了本发明的另一实施例的，其中编成辫的组织植入物正形成为一结。
图32示出了图31的、在编成辫的组织植入物形成为一结之后的植入物。
图33示出了本发明的、编成辫的组织植入物正形成为一结的另一实施例。
图34示出了本发明的、在编成辫的组织植入物形成为一结之后的植入物。
图35示出了本发明的天然组织植入物的又一实施例，示出了利用拉线集聚或折叠一未编成辫的植入物。
图36是依据本发明的一方面的、作为一盘置换装置(disc replacementdevice)插入的一卷天然材料的照片。
图37是依据本发明的一方面的、用作盘置换装置的一卷天然材料的组织剖面图。
                      最佳实施例的描述
为了促使对本发明的原理的理解，现参考优选实施例，将用特定的语言叙述相同的部分优选。无论如何应理解到这不是用于限制本发明的范围，并考虑到与本发明相关的领域内的那些熟悉人员通常会做出所揭示方法和/或装置的变化和进一步修改以及本发明原理的进一步应用。
如以上简要叙述的那样，本发明的一方面提供了利用天然生物组织补充、修复或置换一椎间盘的全部或部分的装置和方法。在本发明的装置和方法中优选地使用天然的、生物组织。
使用在本发明中的组织可以是可植入一病人内的任何天然生物组织。在最佳的实施例中，将从适合于提供如以上所述的功能所必需的强度和结构整体性的组织源选择该组织。
在某些实施例中，该组织可以是例如人的、牛的或猪的心包或小肠粘膜下层(SIS)的扁平组织。还可以利用韧带例如前部的或后部的十字形韧带、筋膜例如阔筋膜、腱例如髌骨的腱、腘绳肌腱、四头肌和阿基里斯腱和其它连接组织。
相对于将使用该组织的病人而言，该组织可以是自身的、同种或异种的。虽然尤其考虑病人，但是也可以用本发明的装置和方法治疗生病的动物。
本发明的组织可以呈一个或多个片状、绳状、孔塞状或适合于植入的任何其它形状而提供。例如，当用于封装一核心以提供一盘或核置换装置时，该组织具有足够尺寸和强度以至少部分地束缚核心材料。当不带有附加的核心材料使用时(例如自身用作为核或盘置换装置)，该组织具有足够尺寸和强度以提供理想的结构。当然，植入物的尺寸和强度按照它是否单独使用或与其它件组合使用、以及是否该组织被扁平使用、或被编成辫、折叠等而变化。
与上述相一致，根据植入物的结构和将如何使用该材料，该天然组织的尺寸和厚度可以变化。例如，当一片组织将被卷起、折叠或层叠为实心的孔塞时，该片优选地为约5-50毫米宽和约20-80毫米长。在另一例子中，当组织片或组织条将封装核心材料时，该片或条优选地为约10-40毫米宽和约30-60长。当用于制造编成辫的植入物时，通常使用约30-200毫米长(更优选约50-100毫米长)、约1-10毫米宽(更优选约2-5毫米宽)的带子。虽然偶尔优选较厚或较薄的实施例，一般该片优选地是1-3毫米厚。
在一优选实施例中，将组织编成辫形成辫形的植入物。编成辫的植入物与不编成辫的植入物比较可以具有较高的强度，它仍可以提供充分的柔性，以允许它集聚或折叠，用于充填一盘空间。在某些优选实施例中，由多个(例如三或以上)扁平组织条制成编成辫的植入物，而在其它实施例中使用圆线。辫形的植入物可以编成辫以形成极强、仍然有柔性的结构，例如当许多薄/细线一起被编成辫以形成一天然组织“绳”。然后该绳可以作为一长、细的段使用，或者可以被折叠或盘卷，以形成一更大体积的结构。如对于在此所述的其它实施例那样，该辫形结构可用于许多医学用途，包括补充、修复或置换一椎间盘的全部或部分，或补充、修复或置换几乎任何其它组织结构、包括韧带、腱等的全部或部分。
天然组织材料可以具有弹性特点，或者它可以是无弹性的。该组织还可以是可变形的或不可变形的。为了本发明的目的，有弹性理解为意味着在植入状态下受拉伸或压缩时材料返回到它的原来形状或几乎返回到它的原来形状。组织的弹性本性提供了较好匹配周围宿主组织的弹性参数的可能性，例如，因而允许盘核或盘置换物更自由地弯曲、构成相对周围宿主组织的更好外形、以及减少植入物沉降进入端板的可能性。为了本发明的目的，可变形理解为意味着一旦植入受损部位该材料可以响应于周围的力而稍许缩小尺寸，以致它适应体内受伤处的缺少或变形组织的部位，用于提高或恢复功能。优选地，本文所述的天然组织植入物由软的、柔性的组织制成，尽管在某些另外的实施例中可以使用硬的、非柔性的组织。
生物组织可以具有光滑的表面，以减少磨损的可能性。并且，如果从组织材料产生磨损微粒，与对合成材料的降解和代谢相比，机体能更好地降解和代谢那些微粒。
会理解到使用天然的、生物组织提供了关于“结疤”的可能性和允许宿主组织生长进入该组织，从而减少了所报道的如关于合成外套设计那样的植入物的逐出的可能性。在某些实施例中，在定位于适当位置之前或之后可以缝合天然生物材料。
该组织可以包括天然的、生物的组织，或者它可以包括从生物组织得到的基质。该生物组织在性能上可以是可降解的或不可降解的。可以使用该组织封装弹性体的或水凝胶的核或椎间盘置换装置，或者可以使用它自身作为核或椎间盘置换装置、而没有附加的中央核心。
至于本发明的方法，可以使用天然组织材料补充、修复或置换一椎间盘、包括盘核和/或盘环的全部或部分，或者可以使用它补充、修复或置调某些其它矫形结构、例如后十字形韧带、屈曲腱、回旋套、半月板或身体内的可以具有弹性或可变形特性的其它类似组织的全部或部分。
在一方面，天然材料用于补充或置换椎间盘核。在这方面，天然组织可作为插入盘环内、以补充或置换天然盘核材料的成卷的、层状的、编成辫的或折叠为“孔塞”的材料而被提供。在本发明的这方面不需要合成核心材料，但如果需要可以协同使用这样的核心。在最少、部分或完全地去除原有盘核的完全或部分椎间盘切除术后可以使用天然组织植入物。
在另一方面，可以利用天然材料补充或置换全部或几乎全部原来的盘-包括盘环。此外该实施方案可以包括一保持结构，以将置换的盘保持在适当位置，如果需要可协同使用一合成核心材料。
在又一方面，可以使用天然生物组织封装弹性体的或水凝胶的核心，以提供核置换装置。水凝胶核装置围绕中央水凝胶材料可能需要某些形式的封装，以约束它们和使它们抵抗横越该盘的负荷的压缩。在利用天然组织封装弹性体的或水凝胶的核心时，获得了以上提到的优点。
在另一方面，可以使用补片或孔塞状的天然材料，以封闭盘环内的孔，或者修复盘核或环。参照所提供的附图在此申请和相关申请中更详细地叙述了这方面和其它方面。
将会理解到本发明的天然组织植入物可以按它们的水合物的形式使用，或者在植入之前它们可以被完全地或部分地脱水。脱水的植入物比水合物的植入物小，由于它们可以通过较小的切口植入，在某些应用中被更优选使用。在一实施例中，将天然组织植入物以脱水的状态植入盘空间，并再水合以形成显著增大的物体。在这些实施例中，再水合组织尺寸增加足以增加盘的高度的，优选足以分开椎骨。
在某些实施例中，将天然组织植入物与合成材料结合使用。在该方面，如以上所述可以使用水凝胶，或者可以附加地或代替地使用其它聚合物、弹性体、塑料、织物、珠、纤维等。可以用于形成天然组织植入物的组成部分的合成材料的例子包括聚乙烯醇、聚丙烯酰胺-聚丙烯酸、聚氨酯、硅酮、硅酮聚氨酯、聚乙烯、丙烯、聚酯、聚对笨二酸盐、聚芳基酮醚等。
在某些实施例中，能够将例如TGF-β、BMP等的生长因子结合进入组织，以便于盘的修复、再生或结合。
参阅附图，图1示出了椎间盘髓核置换装置的一实施例。在该图中天然组织植入物包括位于相邻椎骨12和13之间的和保持在环形纤维化体14内的至少一天然组织11。虽然该图示出了使用植入物置换整个盘核，但是会理解到可以规定植入物的尺寸以置换或补充实际的髓核的全部或仅仅一部分，以帮助保持盘空间的预定高度。而且，所示的植入物具有弹性，以吸收通过椎骨12和13传送的力。在该实施例中，例如，将天然组织11构造成一片或多片组织的一个卷形状。但是，如以下所讨论的也可使用其它适合的结构。
参阅图2，处于植入前状态的植入物20比图1所示的植入的装置可以具有较大的高度“H”和较小的宽度“W”，这是由于在植入物上没有压力。此外，植入物20可以包括一个或多个固定机构25，例如缝线、夹子和如以下所讨论的其它固定件，用于帮助保持植入物的特定外形。固定机构25可以沿着植入物10的整个长度或仅仅部分长度延伸。此外，固定机构25可以穿过植入物的整个厚度或仅仅部分厚度延伸。
图3示出了天然组织植入物的结构的另一实施例。在所示实施例中，植入物30包括能够被折叠、盘卷等以充填盘核空间的一长、细的组织卷。
图4-10示出了本发明的天然组织植入的“编成辫的”实施例。在图4和5中，植入物50包括天然组织的长的、被编成辫的带51。提供拉线52，有助于在植入之后将植入物折叠成较紧凑的结构。拉线52在一端54附近固定于植入物50、在植入物全长的许多部位通过植入物，以及从植入物的另一端55引出以提供用于牵拉该拉线和聚拢该植入物的一个部分53。优选地，拉绳52在每次它通过植入物时从植入物的一侧通到另一侧。以这方式，能够使用拉线“集聚”或“折叠”植入物成为多个被折叠的部分。
如图4所示，植入物50具有一伸直的第一结构。在所示的实施例中，植入物50具有至少五倍于它的宽度W的长度L。更优选地，长度L至少十倍于宽度W。
图5A和5B示出了图4的编成辫的组织植入物，并带有通过植入物的拉线。拉线52固定于编成辫的组织植入物的一端54附近并从第一固定端至第二自由端55的多个部位穿过植入物。如图5B所示，当它在多个部位穿过植入物时拉线52优选地从编成辫的组织植入物的一侧穿到编成辫的组织植入物的另一侧。
拉线52从它在一端附近首先进入辫的位置到它在另一端附近最后离开辫的位置的拉线的长度确定了它的有效长度“E”。拉线52还包括超过它的有效长度的端部53，利用端部53牵拉拉线和折叠编成辫的植入物。可以理解对于特定长度的拉线，随着牵拉拉线以折叠植入物，包括“有效长度”和“端部”的拉线的相应部分发生变化。为了折叠植入物，牵拉拉线52，同时保持自由端55在大体上固定的位置处。这引起植入物的固定端54朝自由端55被拉动，从而集聚或折叠植入物。折叠的数目取决于植入物内拉线52通过其的部位的数量。例如，如果拉线52通过植入物51三次，将形成三个折叠。对于一特定应用所要求的折叠数可以变化，对于某些实施例优选至少一个折叠，对于另一些实施例优选至少两个折叠，对于又一些实施例至少优选三个折叠。
并且，通过提供较多个折叠，可以提供一个具有改进的结构性能和/或优选容积的植入物。另外，通过改变从植入物至植入物的或在单个植入物内的折叠长度，可以得到所需的结构性能和/或所需的最终结构。例如，借助拉线在相互分开较远的部位处通过植入物，可以得到较宽的折叠物，一般提供较宽的折叠的植入物，类似地，通过调节折叠的位置和尺寸，可以得到曲线形的或弧形的植入物。
图6示出了在牵拉拉线和植入物集聚或折叠之后的植入物。通过集聚/折叠缩短了植入物的长度L，同时增加了宽度W。因此，在所示的实施例中，植入物50采取它的第二、折叠的结构，其中长度L小于宽度W的五倍。优选地，在它的折叠的结构中，长度L不大于宽度W的三倍。由于此时较短的拉线位于编成辫的组织的附近或其内，因此相应地缩短了拉线的有效长度。
在某些优选实施例中，无论伸直的植入物的原长度和原宽度，在它的折叠结构中的植入物的长宽比不大于在它的伸直结构中的植入物的长宽比的一半。因此，如果在它的伸直结构中植入物具有10∶1的长宽比，那么折叠的植入物的长宽比优选地不大于5∶1，尽管如以上所指出的，更优选的是不大于约3∶1。
图7示出了植入由盘环77形成的盘核空间78内的编成辫的植入物。植入物71具有一第一端74、一第二端75和至少五倍于它的宽度W的长度L。拉线73固定在第一端74附近和通过植入物以及在第二端75附近引出。如以上所述，在植入物的整个长度上在多个部位拉绳72进入和穿出植入物。可以使用套管76，帮助通过盘环插入植入物。
图8示出了在较多的植入物已被植入之后和已在某种程度上牵拉拉线72以开始在盘核空间内集聚/折叠植入物之后图7的植入物。图9示出了在更多的植入物被植入之后和在继续集聚/折叠之后的植入物。
图10示出了在植入物完全植入盘核空间75之后图7的植入物。充分地牵拉了拉线75以完全地集聚或折叠植入物，以致此时植入物的宽度接近长度尺寸。如该图所示那样，具有图7中伸直结构的约10∶1的长宽比的植入物已被折叠成具有图10的伸直的结构中约2.5∶1的长宽比的植入物。
如图11所示，天然组织植入物110可以包括一叠单独的片111。或者，如图12所示，植入物120可以包括在植入物内已折叠形成多层的一条组织。在所有的情况中，可以使用连接一个或多个单“层”材料的线迹或缝线或另外的固定机构，以提高结构整体性。此外，在所有的情况中，可以切割植入物或对其成形，用于形成具有较自然的形状、例如自然盘核形状的植入物。
图13-15示出了自然组织植入物的另一实施例130。在图13中，植入物130包括由任何适当的固定机构、例如缝线135a-c结合在一起的多个子单元131、132、133和134。最优选地，子单元131-134较小(例如直径5-9毫米和长度8-20毫米)，以致当如图13所示堆置时在椎间盘切除过程之后能够通过在盘环中的较小的孔将它们插入。
一旦植入盘核空间内，例如，可以如图14和15所示折叠子单元131-134，以形成处于第二状态的实际上较宽和较短的植入物。这样的植入物能够，例如较好地承受和分布椎骨间力。
会理解到：子单元131-134不需要是圆柱形的，可以是另外的形状，例如卵形，其中植入物的高度大于宽度(例如，5-8毫米宽，8-10毫米高和8-20毫米长)。这可以便于在环中产生允许植入的较小的切口。而且，可以结合更少或更多数量的子单元。
图16-17示出了类似于图13-15所示的一实施例，但是植入物160包括具有天然组织的片或条165a-c的固定机构，该片或条连接到子单元161-164的侧面的全部或部分，以起到铰链的作用，便于折叠。
图18-20示出了盘核置换装置的又一实施例，以下称为“手风琴式”实施例。在这些图中，植入物180包括由例如缝线189a-j的固定机构保持在一起的多个子单元181-188。如图所示，植入物180可以采取较长、窄的结构，其中诸子单元被折叠成端对端放置的四个子单元的两排；或者可以采取较短、宽的结构，其中诸子单元被折叠成侧面对侧面放置的四个子单元的两排。当植入物容纳于注射管190或其它植入器具内时可以使用长、窄结构，当植入物放植入盘空间内时可以使用短、宽结构。
还会理解到：如图21所示，可能用长缝线或绳216将多个子单元结合在一起。如图22和23所示，可以使用保持夹220和/或230。
在另一方面，将天然组织用作为限制外套，用于封装合成弹性体的或水凝胶的核心。天然组织允许在盘负载状态下核心材料弯曲和变形，同时仍旧提供必要的结构支持。
图24和25示出用于封装弹性体核心的、本发明的天然组织的一实施例。天然组织241限制弹性体核心245，以提供盘核或盘置换装置。可以利用缝线243，以将两件天然组织保持在一起，形成植入物。
图26示出了用于封装弹性体核心的、本发明的天然组织的另一实施例。天然组织261限制弹性体核心262，以提供盘核或盘置换装置。可以使用例如缝线的固定机构闭合限制外套。
可以使用带有或不带有附加核心的盘核或盘置换装置，用于置换损坏的盘核的部分或全部。此外，当被固定以防止从盘空间被逐出时，盘置换装置还可以置换盘环的部分或全部。使用天然材料形成该装置提供了以上所指出的优点。
在本发明的另一实施例中，将天然组织制成用于容纳组织段的一个袋子。袋子和包含在其中的组织可以置换天然盘核。
概括描述“盒”或“袋”实施例，将合成的或天然的组织制成为空袋的形状。可以压缩该空袋子至一小到足以通过椎间盘的环中的小孔而插入的直径，。一旦在盘的内部，它能够通过将天然的或合成的组织的块、条或长绳插入该袋内而充填。该充填通过该袋中的小孔进行。一旦充填了容积，可以缩拢线型缝线或小孔上方的垂片中预先置入的缝线缝合该袋中的孔。
在又一实施例中，由天然组织之外的材料、例如合成聚合物(即聚乙烯、macron等)制造该袋和内含物。
袋实施例的一个优点是它避免了通过环内的大孔插入大的植入物。因为对于插入修补物不要求大孔，所以植入物不容易从盘逐出。还能够通过最小侵害手术插入该袋。
参阅图27-30，示出了袋实施例。图27-29示出了带有插入其中的天然组织袋272的盘环271。可以使用具有插入工具273的装载套管，以将袋272插入盘空间。为了使用装载套管，优选地将袋272定位在装载套管上，以致套管延伸进入该袋内。使用插入工具推动该袋和套管进入在盘环内部的位置中。拆去插入工具，将套管留在适当位置。在袋272和套管274处于适当位置之后，退回装载套管的插入工具273，使用组织276或合成材料(未示出)的块或条，让它们通过套管274，充填袋子272。随着该袋被充填、部分地抽出套管以便于装载整个袋子。当袋子被充填到所需密度时，取出套管。在袋子被充填后，在先前的开口端，用例如缝线300的固定机构将其固定。
在又一实施例中，使用在一端具有一孔并有一拉线以形成一件折叠的组织的天然组织植入物。如图31所示，装置310可以包括具有一第一端315、一第二端316和一第一孔313的天然组织植入物311。使用在端315附近连接于植入物311的拉线312，通过牵拉经过孔313的拉线312，可以折叠该植入物用于形成如图32所示的折叠的植入物。
在另一实施例中，植入物310可以设置有多个孔313，以及通过穿过该多个孔放置固定螺钉，将该植入物用作为韧带置换物。
在图33和34中示出了又一实施例，装置330包括具有多个孔333a-b的天然组织植入物331。可以将拉线332通过孔333a和333b，以折叠该植入物。在某些实施例中，可以通过其牵拉植入物的一端形成打结的植入物，如图34所示。
图35示出了类似于图6-10的编成辫的实施例的实施例，但该植入物包括一条或一片不一定编成辫的天然组织。拉绳352固定于组织条351的一端351b，以及通过牵拉拉绳的自由端，同时保持植入物351的自由端351a固定，以致植入物的其余部分被折叠，这样利用拉绳折叠植入物。如果需要，拉线可以穿过在它的一端处的圈357，以便于扎住该拉线为一结，以保持被折叠的植入物处于它的第二、折叠结构。
会理解到：还考虑了类似于图35所示实施例的又一些实施例，所有这些实施例具有一共同特征：利用拉线，以集聚或折叠一天然组织植入物。因此，在这些实施例中包含天然组织的本体具有较窄的—第一伸直结构和一较宽的(当与第一、伸直外形比较时)—第二折叠结构。这便于通过小切口或孔植入该本体，以及在植入该本体之后将植入物折叠成较宽的结构。
还会理解到：用于折叠本发明的天然组织植入物的拉线可以由天然组织制成，或者它可以由另一材料制成。例如，可以使用合成材料形成拉线。这些合成材料可以是可再吸收的，或者它们可以是不可再吸收的。或者，拉线可以由金属丝或某些其它不可再吸收的材料制成。并且，在某些实施例中在一个装置内可以使用多根拉线。
现参考本发明的一个方面的一特定例子。应理解提供该例子以便更完全地叙述一优选实施例，而不是限制本发明的范围。
例子
为了检验本发明的一方面，在一羊体内植入了由一卷天然组织制成的盘核置换装置。图36示出了植入该动物内的天然组织装置的照片。在图37中示出了植入该动物内六个月之后、该植入物的组织剖面。在许多月内该盘核置换装置功能良好。在核空间内保持在适当位置中的该装置没有被逐出，并保持适当的盘分离和环张力，而没有沉降入端板内。没有磨损微粒的迹象，以及没有观察到细胞炎症。

Claims (48)

1.一种用于补充、修复或置换一椎间盘或它的任何部分的装置，所述装置包括至少一个天然组织，该组织的尺寸和结构被确定为用于插入椎间盘内。
2.权利要求1的装置，其特征在于：天然组织包括生物组织或从生物组织得到的基质。
3.权利要求1的装置，其特征在于：天然组织包括心包组织。
4.权利要求1的装置，其特征在于：天然组织包括小肠粘膜下层。
5.权利要求1的装置，其特征在于：该结构包括多层天然组织。
6.权利要求5的装置，其特征在于：所述多层具有从由一个卷、多个堆置的片和一折叠的单片组成的一组中所选取的一形式。
7.权利要求5的装置，其特征在于：该装置还包括用于将多层中至少两层的至少一部分固定在一起的固定机构。
8.权利要求7的装置，其特征在于：固定机构包括一个从由缝线、夹子等组成的一组中选取的机构。
9.权利要求1的装置，其特征在于：天然组织包括多个子单元。
10.权利要求9的装置，其特征在于：还包括至少一固定机构，用于可动地互连多个子单元。
11.权利要求10的装置，其特征在于：固定机构包括从由缝线、夹子、片材、条材组成的一组中所选取的机构。
12.权利要求1的装置，其特征在于：所述装置包括编成辫的天然组织。
13.一种用于补充、修复或置换椎间盘或它的任何部分的装置，所述装置包括：多个天然组织的子单元，该多个子单元具有尺寸确定为用于放置在椎间盘内的结构；以及，至少一用于互连多个子单元的固定机构。
14.权利要求13的装置，其特征在于：所述子单元各自包括一天然组织卷或孔塞。
15.权利要求13的装置，其特征在于：所述子单元包括编成辫的天然组织。
16.一种补充、修复或置换一椎间盘的全部或部分的方法，所述方法包括在椎间盘内植入一椎间盘装置，该装置包括至少一个天然组织，该组织的尺寸和结构被确定为用于插入在椎间盘内。
17.权利要求16的方法，其特征在于：所述天然组织包括生物组织或从生物组织得到的基质。
18.权利要求16的方法，其特征在于：所述天然组织包括心包组织。
19.权利要求16的方法，其特征在于：所述天然组织包括小肠粘膜下层。
20.权利要求16的方法，其特征在于：所述椎间盘装置包括多层天然组织。
21.权利要求20的方法，其特征在于：所述多层具有从由一个卷、多个堆置的片和一折叠的单片组成的一组中选取的一形式。
22.权利要求16的方法，其特征在于：所述椎间盘装置还包括用于将多层的至少两层的至少一部分固定在一起的固定结构。
23.权利要求22的方法，其特征在于：固定结构包括从由缝线、夹子等组成的一组中选取的结构。
24.权利要求16的方法，其特征在于：所述椎间盘装置包括多个子单元。
25.权利要求24的方法，其特征在于：还包括用于可动地互连多个子单元的至少一固定机构。
26.权利要求25的方法，其特征在于：固定机构包括从由缝线、夹子、片材、条材组成的一组中选取的机构。
27.权利要求16的方法，其特征在于：所述椎间盘装置包括编成辫的天然组织。
28.权利要求27的方法，其特征在于：所述椎间盘装置包括：多个天然组织的子单元，该多个子单元具有尺寸确定为用于放置在一椎间盘内的结构；以及，包括用于互连多个子单元的至少一个固定机构。
29.权利要求16的方法，其特征在于：所述椎间盘装置包括可以折叠在一起的一系列较窄的孔塞段，用于提供较宽的组织孔塞。
30.权利要求17的方法，其特征在于：当折叠在一起形成相对较宽的组织孔塞时，用保持夹将所述系列的较窄的孔塞段保持在一起。
31.用于补充、修复或置换一组织结构的结构，所述结构包括编成辫的天然组织。
32.权利要求31的结构，其特征在于：编成辫的天然组织包括心包组织。
33.权利要求31的结构，其特征在于：编成辫的天然组织包括小肠粘膜下层。
34.权利要求31的结构，其特征在于：编成辫天然组织包括至少三股编成辫的组织。
35.权利要求31的结构，其特征在于：编成辫的天然组织还包括用于将该结构连接于骨的装置。
36.一种用于补充、修复或置换组织结构的装置，所述装置包括一段编成辫的天然组织，其中所述的编成辫的天然组织段具有一第一、伸直的结构和一第二、被折叠的结构，其中所述第一、伸直的结构有一第一横截面尺寸，所述第二、折叠的结构有一第二横截面尺寸，其中所述第一横截面尺寸小于所述第二横截面尺寸。
37.权利要求36的装置，其特征在于：所述装置还包括一拉绳，用于折叠所述编成辫的天然组织段至它的第二、折叠的结构。
38.权利要求36的装置，其特征在于：所述拉线以便于将该装置折叠成具有至少两折叠的第二、折叠结构的方式连接于编成辫的天然组织段的所述长度。
39.一种用于补充、修复或置换组织结构的装置，所述装置包括一段天然组织，其中所述天然组织段具有一第一、伸直的结构和一第二、折叠的结构，其中所述第一、伸直的结构具有一第一横截面尺寸，所述第二、折叠的结构具有一第二横截面尺寸，其中所述第一横截面尺寸小于第二横截面尺寸。
40.权利要求39的装置，其特征在于：所述装置还包括一拉线，用于将所述天然组织段折叠成它的第二、折叠的结构。
41.权利要求40的装置，其特征在于：所述拉线以便于该装置折叠成具有至少两折叠的第二、折叠的结构的方式连接于天然材料段的所述长度。
42.一种用于补充、修复或置换一椎间盘核的装置，所述装置包括：(a)具有一第一端和一第二端的编成辫的天然组织植入物；以及，(b)一拉线，所述拉线固定于所述编成辫的组织植入物的第一端附近和在从第一端至第二端的多个部位穿过所述植入物；
其中所述植入物形成一第一、伸直的结构，在该结构中当所述拉线具有几乎等同该伸直的天然组织的长度的有效长度时，该植入物具有至少5∶1的长宽比，以及
其中所述植入物形成一第二、折叠的结构，在该结构中，当所述拉线具有短于该伸直的天然组织的长度的有效长度时，该植入物具有小于5∶1的长宽比。
43.权利要求42的装置，其特征在于：天然组织包括编成辫的心包组织。
44.权利要求42的装置，其特征在于：天然组织包括编成辫的小肠粘膜下层。
45.权利要求42的装置，其特征在于：所述拉线在植入物全长的多个部位穿过编成辫的植入物，所述多个部位至少是三个部位。
46.权利要求45的装置，其特征在于：所述拉线通过至少五个部位。
47.权利要求46的装置，其特征在于：所述拉线通过至少十个部位。
48.一种用于补充、修复或置换椎间盘核的方法，所述方法包括：
(a)提供具有一第一端、一第二端和拉线的编成辫的天然组织植入物，其中拉线固定于所述编成辫的组织植入物的第一端附近并在从第一端至第二端的多个部位穿过植入物，以及其中所述植入物形成一第一、伸直结构，在该结构中当所述拉线具有接近等于该伸直天然组织的长度的有效长度时该植入物具有至少5∶1的长宽比；
(b)将所述伸直的植入物植入椎间盘空间；以及
(c)引起所述编成辫的组织植入物采取-第二、折叠的结构，在该结构中植入物具有小于5∶1的长宽比；所述引起作用通过减少所述拉线的有效长度完成。
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