CN101056597A - 骨移植物及其制造方法 - Google Patents

骨移植物及其制造方法 Download PDF

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Publication number
CN101056597A
CN101056597A CNA2004800194995A CN200480019499A CN101056597A CN 101056597 A CN101056597 A CN 101056597A CN A2004800194995 A CNA2004800194995 A CN A2004800194995A CN 200480019499 A CN200480019499 A CN 200480019499A CN 101056597 A CN101056597 A CN 101056597A
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CN
China
Prior art keywords
graft
bone
interconnection
adjacent
bone piece
Prior art date
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Pending
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CNA2004800194995A
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English (en)
Inventor
J·J·宾德赛勒
T·A·西蒙敦
C·R·里夫斯
W·F·麦克凯
E·F·雷三世
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Warsaw Orthopedic Inc
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Warsaw Orthopedic Inc
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Application filed by Warsaw Orthopedic Inc filed Critical Warsaw Orthopedic Inc
Publication of CN101056597A publication Critical patent/CN101056597A/zh
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Abstract

本发明提供用于融合相邻骨结构的移植物(10)。移植物包括多个骨块(12)和含有一个或多个使骨块相互连接的柔性的、细长的、生物相容连接件的柔性装置(14)。

Description

骨移植物及其制造方法
发明背景
通过将相邻骨结构维持在预定间隔关系中同时使骨在它们之间生长，以使用于融合相邻骨结构的移植物促进融合。在一些情况下，这些移植物是由身体组织形成的。在从身体组织形成移植物的过程中，使组织来源例如骨形成满足具体移植物所需的形状和强度要求的块。对于骨，该要求常常被具体描述为最小壁厚度、最小承载能力和/或几何大小和形状。源组织的一部分，包括在形成移植物中去除的部分将达不到形成完整移植物的要求。因此，常常难以从具体来源获得高产量。
发明概要
本发明提供了用于融合相邻骨结构的移植物。
在本发明的一个方面，用于融合相邻骨结构的移植物包括多个骨块和一个柔性装置，该柔性装置包含一个或多个使多个骨块相互连接的柔性的、细长的、生物相容的连接件。
在本发明的另一方面，移植物还包括一种基体，且相连骨块形成与基体结合的一串相互连接的骨块，以形成移植物。
附图简要说明
将参考附图讨论本发明的各种实施例。这些附图仅描述本发明的示例性实施例，并不认为是对其范围的限制。
图1是用于制造本发明移植物的相互连接的骨块的示例性实施例的立体图。
图2是图1所示相互连接的骨块的立体图，骨块间具有另一种间隔。
图3是图1所示相互连接的骨块的立体图，骨块间具有另一种间隔。
图4是通过组合图1-3所示的相互连接的骨块形成的多层移植物的立体图。
图5是通过组合图1-3所示的相互连接的骨块形成的多层移植物的立体图，骨块是更细长的。
图6是通过将图1所示相互连接的骨块与基体组合形成的移植物的立体图。
图7是通过将图1所示相互连接的骨块与基体组合形成的移植物的立体图。
图8是侧面示意图，显示图1-7所示移植物与固定在骨上的附加固定装置的组合。
具体实施方式
骨移植物的实施例包括多个通过柔性装置相互连接的骨块，形成用于融合相邻骨结构的承载移植物。相邻骨结构可包括椎骨、长骨和颅骨等。用于移植的骨可来自任何合适的骨来源，包括移植受者作为自体移植，相同骨块的另一种来源作为同种异体移植，或不同骨块来源作为异种移植。骨骼肌组织合适的例子包括：肱骨、胫骨、股骨、腓骨、髌骨、尺骨、桡骨、肋骨、椎体等。可通过机加工、刨削、磨削、轧碎、切割、铣削、碎裂、斩断、压碎和/或其它合适的方式形成骨块，以移除骨或将源骨减小为更小的骨块。骨块可以是颗粒状、随机块状、纤维状、条状、棍状、直角棱柱状、立方体形、球形、圆柱形和/或任何其它合适的形状。每个骨块可包含皮质骨层。每个皮层骨块的预定皮层厚度和几何形状比与供体骨形成的完整的或组装的移植物有关的预定最小壁厚或几何形状小。将多个骨块组合成移植物允许供体骨比用于形成承载移植物的预定的最小承载强度或几何形状小。骨块可具有任何合适的纵向长度、任何合适的宽度以及任何合适的高度。此外，多个骨块各自还可包含邻近皮质骨层的松质骨层。
一个或多个柔性装置可使多个骨块或骨条相互连接，形成承载移植物。柔性装置可以包含一个或多个使骨块相互连接的柔性的、细长的、生物相容的连接件。制造连接件的材料的例子可包括：心包、去矿质骨、筋膜、软骨、腱、韧带、皮肤、胶原、柔性蛋白、网状组织、肠粘膜下层、金属、可再吸收聚合物、不可再吸收聚合物和/或其它合适的材料。
柔性装置可隔开诸骨块，使相邻骨块以预定间隔分离。相邻骨块之间可具有最小间隔或没有间隔，得到较刚性的相互连接移植物。或者，诸骨块的间隔可提供较柔性的相互连接移植物。相邻骨块的间隔可允许在相邻的相互连接骨块处折叠移植物。在一个移植物中可组合刚性和柔性间隔，以使第一对相邻骨块和第二对相邻骨块间的预定间隔可不同，使得移植物的第一部分较刚性且移植物的第二部分较柔性。可在第二部分处折叠这种移植物，提供在其自身之上折回的较厚移植物，并带有在折叠之间的较刚性部分。可通过固定装置，例如系在柔性装置中的结、固定于柔性装置的止动件、骨块和柔性装置的结合件和/或其它合适的固定装置，限制骨块相对于柔性装置的移动。可通过用粘合剂锁缝和/或其它合适的方式，将止动件固定于柔性装置。柔性装置可结合在骨块的外面，和/或每个骨块可包含一个或多个孔使柔性装置通过这些孔结合骨块。
相互连接的骨块可形成一个或多个承载移植物层。例如，多个相互连接的骨块可形成一层。并且，多个相互连接的骨块串或链可相邻放置和/或相互连接形成一层。此外，多个相互连接的骨块可形成一层，例如通过滚卷或折叠单层形成多层或通过堆叠多个相邻单层，多个相互连接的骨层可形成移植物。具有一层或多层的移植物可具有基本上垂直于一层或多层的层轴线和承载轴线，载荷沿承载轴线从相邻骨结构施加于移植物。移植物层轴线的方向可基本上垂直于、基本上平行于或以某种其它合适的角度倾斜于承载轴线，从而对移植物定向。
而且，通过附加互连结构将多层系在一起，可使多层固定在一起。互连结构的例子包括：编结、钉销、缝合、压制、包含粘合剂、胶原交联或使多层相互连接的任何其它方式。
对于编结，可以按预定的图案使相互连接的骨块串编结在一起，形成编结的骨层。
如果将多层钉销，骨块中可形成孔，可将由骨、陶瓷、金属、聚合物和/或其它合适的材料形成的刚性销针压制入孔以连接多层。
如果将多层缝合在一起，可形成通过一个或多个骨块的两个孔，每个骨块中的一个孔可用于形成相互连接的骨块串，一个或多个骨块中的第二个孔可用于连接多层。
如果用粘合剂连接多层，它可以是胶性粘合剂、水泥质粘合剂和/或其它合适的粘合剂。胶性粘合剂的例子包括纤维蛋白胶、氰基丙烯酸酯、环氧树脂、聚甲基丙烯酸甲酯、基于明胶的粘合剂和其它合适的粘合剂以及它们的混合物。水泥质粘合剂的例子包括可凝固陶瓷、碳酸钙、磷酸钙、石膏和其它合适材料以及它们的混合物。
如果用骨胶原交联将多块互相连接，则可使一些骨块部分地去矿质以暴露骨胶原纤维，然后通过施加热、压力、化学物质和/或其它交联方法可使骨胶原纤维交联。
相互连接的骨块和/或由其形成的骨层可与基体组合，形成移植物。例如，通过使骨块串围绕基体和/或在基体中定位的缠绕、编结、卷绕、填塞或其它方法，具有合适形状的基体可与一串相互连接的骨块组合。还可通过类似于层相互连接中所述的钉销、缝合、压制、包含粘合剂、骨胶原交联和/或任何其它合适的连接方式，使骨块连接于基体。基体可为直角棱柱状、球形、盒形、环形、圆柱形、管形、″D″-形、″C″-形和/或任何其它合适的形状。基体可由骨、可再吸收聚合物、不可再吸收聚合物、金属、陶瓷、碳和/或任何其它合适的材料构成。
移植物还可包括一个或多个通过移植物的开口，以促进相邻骨结构的融合。可通过钻孔、切削、冲孔或其它合适的方式形成一个或多个开口。移植物还可包括在一层或多层内、层之间、和/或(如果存在)在一个或多个开口中的骨生长促进物质。骨生长促进物质的例子包括：生长因子，成骨蛋白，骨成形蛋白，包括人重组骨成形蛋白，LIM矿化蛋白，骨糊，骨碎片，去矿质骨，羟基磷灰石，激素，血小板衍生生长因子，骨髓抽提物，干细胞，血小板衍生生长因子、和/或其它合适的骨生长促进物质。一个或多个开口可具有纵轴线，方向可被确定成使其纵轴线平行于移植物的承载轴线，以进一步促进相邻骨结构间的融合。
参考图1-3，一种示例性移植物10包括通过柔性装置14相互连接的多个骨块12，形成相互连接骨块串或链。柔性装置可是如图1所示的单一连接件或是如图3所示的多个连接件。在示例性实施例中，骨块包括孔16，柔性装置14穿过诸孔。骨块相互间以预定距离20隔开。在图1中，预定距离较宽，得到较柔性的移植物。在图2中，预定距离20最小，得到较刚性的移植物。在图3中，诸预定距离20不相同，使得一部分移植物较柔性而一部分较刚性。图3的构造促使在较宽的预定距离20处折叠移植物，例如在其自身之上向后折叠它，形成多层移植物。可采用固定装置18如帽或结，以限制骨块12相对于另一个骨块和/或柔性装置14的移动。或者，骨块12可结合于柔性装置14。
骨块可具有多个孔，以使进一步相互连接。在图1中，显示了立方体骨块，通过立方体六个面的孔的方向基本上相互垂直。多串骨块10，类似于图1中所示，组合形成图4的层叠的移植物。骨块串10相互邻近放置，形成所需大小的移植物。通过骨块中附加的孔连接附加的连接件，以使骨块串10系在一起形成层24和最终移植物26。
在图5中，多个细长的骨块12相互连接，形成层24，堆叠层24并系在一起形成多层移植物28。
或者，如图6所示，可编结、盘绕或缠绕一个或多个相互连接的骨块串，形成移植物34。一个或多个串可与基体30组合，得到移植物34的预定形状和/或刚性。示例性基体为中空″D″形。相互连接的骨块围绕移植物螺旋盘绕，形成具有所需几何形状和承载能力的移植物。移植物还包括孔36，以促进相邻骨结构的融合。移植物中包含骨生长促进物质38，例如在孔36内，以进一步促进融合。图7显示了带有一串相互连接的骨块盘绕并位于孔36内的中空圆柱形基体30的另一种构造32。
图8示意性地显示了如上所述的移植物60与固定装置62联合使用，形成骨固定系统64。在这种系统64中，融合移植物60位于需要融合在一起的相邻骨结构66、68之间。固定装置62可包括一个或多个锚定装置72，如螺钉、销、金属丝和/或其它用于将其与相邻骨结构66、68连接的装置，以限制它们之间的相对运动。固定装置62可基本上防止所有相对运动，或它可允许预定的运动量，例如使移植物60在治愈和融合过程中保持与相邻骨结构66、68相接触。固定装置62的合适例子包括板、内部或外部杆系统、索系统、环扎系统、螺钉和其它合适装置及其组合。
从供体骨的纵轴线径向测量，含有皮质骨的骨块可具有比预定的最小壁厚度和几何形状小的预定的层厚度和几何形状。例如，在一个实施例中，预定的层厚度和几何形状可以在厚度小于2毫米的范围内，在另一实施例中厚度小于1.8毫米，在又一实施例中厚度小于1.5毫米，在又一实施例中厚度小于1.0毫米，在另一实施例中厚度小于0.5毫米。而且，例如，预定的最小壁厚度和几何形状可涉及与形成完整的或组装的承载移植物有关的最小可接受厚度或几何形状。预定的最小皮质几何形状可依应用而不同。例如，用于颈椎的最小几何形状可显著小于用于腰椎的最小皮层几何形状。例如，在一个实施例中，例如从腓骨形成的完整或组装的皮质楔形颈椎移植物的预定最小壁厚度或几何形状可以是3.0毫米，在另一实施例中是2.5毫米，在又一实施例中是2.0毫米，在又一实施例中是1.8毫米。另一方面，在一个实施例中，完整或组装的腰椎移植物的最小皮质几何形状可以是4.5毫米，在另一实施例中是4.0毫米，在另一实施例中是3.5毫米。
从多个骨块形成的移植物的耐压强度，或承载能力的范围为50牛至20,000牛。例如，实施例可具有大于70牛、或大于800牛、或大于1000牛、或大于1200牛、或大于3000牛、或大于5000牛、或大于7000牛、或大于10,000牛、或大于12,000牛、或大于15,000牛、或大于17,000牛的耐压强度。此耐压强度提供的承载能力大于一般松质骨并高达一般皮质骨的承载能力。
虽然详细描述和示出了移植物的实施例和制造骨移植物的方法，但是应理解，这些只是说明和示例的方式，而不是限制方式。因此，对移植物和方法的改变和修改对于本领域普通技术人员来说是显而易见的，所附权利要求书意于覆盖所有这些修改和等价形式。

Claims (52)

1.一种用于融合相邻骨结构的移植物，包括多个骨块及含有一个或多个使骨块相互连接的柔性的、细长的、生物相容连接件的柔性装置。
2.如权利要求1所述的移植物，其特征在于，所述骨块包含基本上直角棱柱状的骨。
3.如权利要求2所述的移植物，其特征在于，所述骨块包含基本上立方体形的骨。
4.如权利要求1所述的移植物，其特征在于，所述柔性装置在相邻骨之间延伸，通过折叠延伸在相邻骨之间的柔性装置，一些骨块折回在其它骨块上。
5.如权利要求1所述的移植物，其特征在于，所述各骨块包含至少一个具有预定承载能力的皮质骨部分。
6.如权利要求5所述的移植物，其特征在于，所述各骨块还包含松质骨部分。
7.如权利要求1所述的移植物，其特征在于，所述各骨块包含一个或多个孔，柔性装置通过这些孔结合骨块。
8.如权利要求1所述的移植物，还包括固定装置，以限制一个或多个骨块相对于柔性装置的运动。
9.如权利要求8所述的移植物，其特征在于，所述固定装置包括在骨块附近的一个或多个系在柔性装置中的结。
10.如权利要求8所述的移植物，其特征在于，所述固定装置包括在骨块附近的一个或多个固定于柔性装置的止动件。
11.如权利要求10所述的移植物，其特征在于，所述止动件卡在柔性装置上。
12.如权利要求1所述的移植物，其特征在于，所述骨块在相邻的互连骨块之间隔开预定的间隔。
13.如权利要求12所述的移植物，其特征在于，骨块间存在最小间隔或没有间隔，形成较刚性的互连移植物。
14.如权利要求12所述的移植物，其特征在于，骨块间的间隔产生较柔性的互连移植物。
15.如权利要求12所述的移植物，其特征在于，所述骨块间的间隔允许在自身之上向后折叠互连块。
16.如权利要求12所述的移植物，其特征在于，所述预定间隔与连续的互连骨块对之间的间隔基本相同。
17.如权利要求12所述的移植入，其特征在于，所述预定间隔在第一对相邻骨块和第二对相邻骨块之间不同，使得移植物的第一部分较刚性而移植物的第二部分较柔性。
18.如权利要求17所述的移植物，其特征在于，所述移植物在第二对相邻骨块处折叠。
19.如权利要求1所述的移植物，其特征在于，所述各骨块具有小于预定最小承载能力的预定承载能力，且互连骨块形成具有大于预定最小承载能力的预定承载能力的移植物。
20.如权利要求1所述的移植物，其特征在于，所述各骨块具有在与单一移植物相关的预定标准之外的预定几何形状，且组合块形成达到预定几何形状的组装的移植物。
21.如权利要求1所述的移植物，其特征在于，所述柔性装置包括一个或多个含有至少一种选自以下材料的柔性的、细长的、生物相容的连接件：心包、去矿质骨、筋膜、软骨、腱、韧带、皮肤、胶原、柔性蛋白、网状组织、肠粘膜下层、金属、可再吸收聚合物和不可再吸收聚合物。
22.如权利要求1所述的移植物，其特征在于，所述互连骨块形成一个或多个承载移植物层。
23.如权利要求22所述的移植物，其特征在于，所述一层或多层由多个位置相邻的互连骨块串形成，位置相邻的诸串之间相互连接。
24.如权利要求23所述的移植物，还包括使位置相邻的诸串相互连接的附加的柔性装置。
25.如权利要求23所述的移植物，其特征在于，每个骨块包括方向基本上相互垂直的至少第一和第二通孔，互连骨串中的骨块由穿过第一通孔的柔性连接件相连，位置相邻的互连骨块串由穿过第二通孔的柔性连接件相连。
26.如权利要求22所述的移植物，其特征在于，所述一层或多层包括形成盘绕螺旋结构的一串互连骨块。
27.如权利要求22所述的移植物，其特征在于，所述一层或多层包括一次或多次在自身之上向后折叠的一串互连骨块。
28.如权利要求22所述的移植物，还包括沿基本上垂直于诸层和承载轴线的层轴线相互重叠的多层，载荷沿着承载轴线从相邻的骨结构施加于移植物，层轴线基本上垂直于承载轴线。
29.如权利要求22所述的移植物，还包括沿基本上垂直于诸层和承载轴线的层轴线相互重叠的多层，载荷沿着承载轴线从相邻的骨结构施加于移植物，层轴线基本上平行于承载轴线。
30.如权利要求1所述的移植物，还包括基体，且其中所述互连骨块形成互连骨块串，所述互连骨块串与基体结合形成移植物。
31.如权利要求30所述的移植物，其特征在于，所述互连骨块串围绕基体盘绕。
32.如权利要求30所述的移植物，其特征在于，所述互连骨块串围绕基体编结。
33.如权利要求30所述的移植物，其特征在于，所述基体还包括内部，且互连骨块串位于所述内部之内。
34.如权利要求33所述的移植物，其特征在于，所述互连骨块串卷绕在所述内部之内。
35.如权利要求33所述的移植物，其特征在于，所述互连骨块串填塞在所述内部之内。
36.如权利要求30所述的移植物，其特征在于，所述互连骨块串以螺旋图形围绕基体盘绕。
37.如权利要求30所述的移植物，其特征在于，所述互连骨块串通过至少一种选自包括以下的连接装置在与基体相连：钉销、缝合、压制、包含粘合剂及胶原交联。
38.如权利要求30所述的移植物，其特征在于，所述基体包括至少一种选自以下的形状：盒形、环形、圆柱形、管形、球形、“D”-形和“C”-形。
39.如权利要求30所述的移植物，其特征在于，所述基体包含至少一种选自以下的材料：骨、可再吸收聚合物、不可再吸收聚合物、金属、陶瓷和碳。
40.如权利要求30所述的移植物，其特征在于，所述基体还包括至少一个通孔以促进相邻诸骨结构的融合。
41.如权利要求40所述的移植物，还包括承载轴线，载荷沿承载轴线从相邻的骨结构施加于移植物，所述至少一个通孔具有平行于承载轴线的纵轴。
42.如权利要求40所述的移植物，还包括在所述至少一个孔内的至少一种骨生长促进物质。
43.如权利要求42所述的移植物，其特征在于，所述骨生长促进物质包括至少一种选自以下的物质：骨衍生生长因子、成骨蛋白、人重组骨成形蛋白、LIM矿化蛋白、骨糊、骨碎片、去矿质骨、羟基磷灰石、激素和血小板衍生生长因子。
44.如权利要求1所述的移植物，其特征在于，单一柔性装置基本上互连所有骨块，所述骨块在相邻的互连块之间隔开预定的间隔，所述预定间隔在第一对相邻骨块和第二对相邻骨块之间不同，给予移植物预定的柔性。
45.如权利要求1所述的移植物，还包括开口以促进相邻骨结构的融合。
46.如权利要求45所述的移植物，还包括在至少一个开口内的至少一种骨生长促进物质。
47.如权利要求46所述的移植物，其特征在于，所述骨生长促进物质包括至少一种选自以下的物质：骨衍生生长因子、成骨蛋白、人重组骨成形蛋白、LIM矿化蛋白、骨糊、骨碎片、去矿质骨、羟基磷灰石、激素和血小板衍生生长因子。
48.如权利要求1所述的移植物，还包括连接于所述相邻骨结构的固定装置以限制它们之间的相对运动。
49.一种治疗身体以促进相邻骨结构融合的方法，所述方法包括以下步骤：
提供多个骨块；
使多个骨块与柔性的、细长的、生物相容的连接件相互连接，形成移植物；和
将移植物置于相邻骨结构之间。
50.如权利要求49所述的方法，其特征在于，所述互连骨块在相邻的互连块之间隔开预定的间隔，所述预定间隔在第一对相邻骨块和第二对相邻骨块之间不同，使得移植物的第一部分较刚性而移植物的第二部分较柔性。
51.如权利要求49所述的方法，还包括使互连骨块形成多个相互堆叠的承载层的步骤。
52.如权利要求49所述的方法，还包括基体，且其中所述互连骨块形成互连骨块串，所述互连骨块串与基体结合形成移植物。
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