CN101083958A - 最低程度侵入的面关节融合装置的脊椎塞 - Google Patents

最低程度侵入的面关节融合装置的脊椎塞 Download PDF

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CN101083958A
CN101083958A CNA200580039815XA CN200580039815A CN101083958A CN 101083958 A CN101083958 A CN 101083958A CN A200580039815X A CNA200580039815X A CN A200580039815XA CN 200580039815 A CN200580039815 A CN 200580039815A CN 101083958 A CN101083958 A CN 101083958A
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大卫·A.·彼德森
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Abstract

截椎体形主体在顶表面上具有孔，在侧表面上的一对第一和第二对置的孔，第一和第二水平内通道连接第一和第二对置的孔。源自顶孔的垂直通道与第一和第二通道连接。在主体插入面关节内的孔后，适合的人造或生物材料导入垂直通道，直到材料从侧表面上的第一和第二孔流出。主体的外侧表面的一部分上的至少一对凸缘作为定位器，以将主体保持在面关节孔内的适当位置。

Description

最低程度侵入的面关节融合装置的脊椎塞
技术领域
本发明一般涉及最低限度地侵入式脊柱手术，更特别地涉及利用关节镜形入口或开放面关节融合手术器械，以用于将预先制成、预先成型的人造骨皮质或切割并压缩的髂嵴移植物、自体或尸体的同种异体移植物插入。移植物和融合装置被限制在位于C1-C2到L5-S1脊骨的48个面关节。
背景技术
仅在美国，就有整个人口的大约10％将在随后的12个月的某些时候遭受背痛。在随后的一年内，与受到其它伤害或感染除了感冒和流感以外的疾病的人相比，更多的人感染背痛。大约三分之一的人将不会恢复并不得不与永久的丧失能力症状相伴。数量年年都在增加。
背痛，特别是永久的、丧失能力的背育类型的根本原因之一是面关节，是允许脊柱运动的在脊柱中位于相邻的脊骨后面的小关节。
目前对于数百万的面关节机能障碍的人可利用的手术方法是基于高风险操作的复杂的、侵入性的茎螺钉，并具有6个月至24个月的延长的恢复时间和不确定的手术结果。高风险等于频繁的起诉，其迫使非手术症状处治，而令疾病或伤害的后果日渐严重。一些这些努力提供了描述在美国专利号6485518和美国专利申请号2003/0032960中的椎间融合。由于接近或设计，许多可能或不包括面关节的脊骨通常融合的专利已经被授权。
随着新的、更安全的更少侵入的外科方法和技术的出现，现在脊椎手术的增加超过所有其它外科整形手术部分。巨大的需求进一步推动其增长。
发明内容
预成形的切割的或人造的骨头用作面关节融合的结构固定提供了超越目前应用于面融合手术中的杆或压缩螺钉的三个明显的优点：即(1)利用骨头替换金属允许自然的骨头向内生长和更牢固的永久的融合；和(2)随着时间的推移，天然或人造的移植物不会使其方式变松，这是螺钉类型固定的一个顾虑。
移植物和系统特别设计成在最低限度侵入或关节镜形入口用于独立处理，在用作中介的椎骨融合的附件时，通过显著地减少由于持久的面关节运动引起的面关节疼痛的风险，从而提供更牢固的、独特和较好的融合。
用于不适于表面重修或替换的患病或疼痛的面关节的治疗的最低程度侵入的面关节融合包括利用装置和自体移植物、尸体的同种异体移植物或FDA批准的人造预制、预成形的皮质骨移植物，以用于最低程度侵入、门诊的、关节镜的脊椎手术或标准的开放手术，更特别地用于融合从C1-C2到L5-S1的脊椎的面关节。该装置用作基本手术或修正手术。
本发明通过利用C1-C2到L5-S1的脊椎的面关节的关节镜入口或开放手术技术，提供移动替换物以便于融合，从而实现较好的脊椎面关节的融合。
根据本发明的一个主要方面，关节镜式面关节融合装置包括冲孔机或钻孔机，其制造出以圆锥形式穿过面关节两侧的孔。该孔用病人自己的切割的和压缩的使用髂嵴自体移植物、预制作预成形的皮质的尸体的同种异体移植物(自体移植物或由挤压或加工的骨塞形成的同种异体移植物)或FDA批准的人造预制、预成形的人造移植物骨塞填充。
使用关节镜或类似的入口以接近关节或在标准的开放手术过程中，冲孔机或钻孔机包括任意数量的能完成制造穿过脊椎面关节两侧的孔的构件。仅作为例子，冲孔机或钻孔机包括手动启动器，其将会产生足够的压力来形成穿过脊椎面关节的两侧的特定尺寸的孔，使用类似于调整大小的普通钳子的机械装置穿过关节镜的孔工作。此外，可以设置钻孔机导向装置，并可以使用特定尺寸和形状的钻头，以形成水平方向或垂直方向穿过面关节的孔。
骨塞压力机(移植物形成或压缩装置)包括任意数量的构件，能使用切割的自体移植物、尸体的同种异体移植物皮质骨或人造替换物来匹配由钻孔机或钻孔机制成的骨孔道。仅作为例子，骨塞压力机包括类似于普通钳子或更标准的手动压力机的机构，其将传递足够的力，通过将手柄挤压到一起以形成骨塞，并将骨头或人造替换物压缩适当的密度和形状，来形成骨塞。冲击器或压具包括任意数量的构件，能将骨塞推压入骨孔道。还可以应用缝线或金属覆层，以在移植物结合过程中对关节提供附加的结构稳定性。
附图说明
对于本领域的技术人员，结合附图阅读本说明书的情况下，本发明的许多优点将是显然的，其中，同样的附图标记用于相同的部件，其中：
图1表示就用于面关节融合的本发明的截椎体形骨塞；
图2表示用于准备用骨塞的锥形钻头；
图3表示为骨塞准备的孔；
图4表示插入图3的孔中的骨塞和用于插入人造或生物材料的施加管；
图5为沿图4中线5-5剖开的剖视图；
图6为沿图4中线6-6剖开的剖视图；
图7为根据图6的剖视图，表示人造或生物材料将骨塞胶接在适当位置；
图8表示第一可选的截椎体形骨塞；
图9为图8中的截椎体形骨塞沿线9-9的剖视图；和
图10为第二个可选的截椎体形骨塞。
具体实施方式
参见图1，本发明的骨塞为插入式的截椎体形装置10，具有垂直的中心通道12，用于人造或生物材料的插入，以辅助将骨塞10融合在脊椎关节15的适当位置。骨塞10具有若干侧件14和16，用于人造或生物材料从中心通道12的排出。设置在底端22附近的同一平面上部分地围绕骨塞10的一对对置的凸缘18和20，底端22具有比顶端24小的直径。
为了融合脊椎面关节，如图2所示，锥形钻头26用于准备如图3所示的在骨30和32之间的孔28。如图4所示，施加管34插入通道12，以使人造或生物材料36插入骨塞10。如图5所示，生物材料36流下通道12，多余的生物材料流出侧件14和16并分别通过通道42和44进入骨30和32与骨塞10的外侧壁40之间的空隙38。凸缘1 8和20作为定位器以将骨塞10保持在孔28内的适当位置。进一步如图7所示，生物材料36从孔14和16向外流入空隙38以将塞10胶接在适当位置。
一种可选择的塞10a表示在图8和图9中。中心通道12a将生物材料输入侧通道46、42和44a。以类似的方式，生物材料36流出开口52、14a和16a并促进向骨头的结合。第二平行的一对凸缘48和50添加于凸缘18a和20a上，以提高塞10a在通道28内的强度。与塞10相似的侧壁40a，其底端22a的直径比其顶部24a的直径小。
如果关节被确定为过度地损坏或败坏，对于目前的替换方法或如面关节半关节成形术的可预见的方法，那么最低程度侵入式面关节融合是可预见的更好的选择，因为三个主要原因：
(1)其是最低程度侵入式手术，与在医院实施的大多数手术相比，可以在门诊条件下实施。如果由于医生特别结合用仪器引导的椎骨融合确定需要面关节融合，该手术也可以在开放的手术过程中实施；
(2)与6至12个月相比，可以预期恢复时间将是几个星期；和
(3)其在生物材料和人造替换物的进展上取得了完全的优势。
本发明来克服或至少改善现有技术的缺陷，通过实现下述，：
●与本发明相比，目前手术的成本/利润率的逆转；
●与大多数开放的手术相比，最小程度的侵入手术；
●与住院手术相比的门诊手术(与数小时相比的每个关节约20分钟)。
注意：这个手术也可以在开放式手术中按医生的意愿来实施。
●可以用于增强目前开放式融合技术，以减小对骨头刺激的需要，特别是在如吸烟者和多级病症的高危人群中；
●减少的发病率；
●减少的失血；
●减少麻醉状态下的时间；
●减小风险；
●恢复时间显著减少；
●最低程度的疤痕，其减少了失败的背部综合症的风险并提高修正手术结果；
●由于显著地减少了手术室时间和软组织损伤，减小了术后感染的风险；
●不排除其它手术的或非侵入式处治疗选择；以及
●通过利用普遍使用的关节镜检查方法以形成并准备骨头或新的预成形、预制作的人造皮质骨替换物能预期很高的成功率，关节镜检查方法使用新技术和利用任一现有的皮质骨切割方法结合独特的仪器，由于人造皮质骨替换物由FDA批准制造并通常可以得到。
可以预见，本系统和移植替换物的实用性将显著地增加实施的手术的数量，因为其提供了针对脊椎关节痛的主要原因的第一安全的门诊手术方案。可以预料接受该手术的几乎所述病人将能够在同一天走出并在几周内将恢复全部的功能。目前的手术方案需要大约三天的住院和六至二十四周的恢复期。
除了显而易见的积极的临床效果，对于残疾、工人的赔偿和卫生保健保险人的显著有利的财务的影响是相当大的。脊椎面移植单元是以每个关节计算的。每个病人的每个脊椎段具有两个关节，并具有二十四段，C1-C2到L5-S1，共有四十八个面关节。每个手术可能要包括多个关节。
本发明的目的在于克服或至少是改善现有技术的缺陷。
在插入塞10的过程中，特别使用锥形钻头穿过关节镜形入口，通过介入的软组织的小切口和逐渐的扩张接近关节。装置设计不排除其用于标准的开放手术或通过其他有限的切口接近面关节。开口28在边上小于骨塞10，以形成塞10和关节的正确地固定。
再参见图1和图8，融合的面关节塞10、10a或10b表示为一次成型的自体移植物、尸体的同种异体移植物或FDA批准的人造预制、预成形的皮质骨塞。塞10或10a的前端22或22a的直径为3-8mm，塞10、10a或10b的后端24或24a的直径是4-12mm，成更宽部分位于后端的截椎体形的形状，以便于在骨移植结合过程中的固定。手术预计每个面关节仅需要一个骨塞，每段需要两个。当随着时间的推移，骨生长发生在关节本身内和塞内时，就形成永久的固定。
当不需要附加的生物材料时，可以使用如图10所示的截椎体形的骨移植物10b。
其它等同部件可以替换此处公开的部件，以基本相同的方法产生基本相同的效果。

Claims (21)

1.一种面关节融合塞，包括：
基本立体的截椎体形主体，具有在顶表面上的孔、在侧表面上的一对第一对置的孔和在侧表面上第二对对置的孔，第一对置的孔和第二对置的孔设置在远离顶表面的主体的下部；
从顶表面上的孔向下指的垂直通道，该垂直通道与连接对置的第一对孔的第一水平通道相交，并终止于连接第二对置的一对孔的第二水平通道；
至少一对凸缘，部分地围绕主体的外表面的底部；以及
主体由选自人造皮质骨、切割的人造皮质并压缩的髂嵴移植物和尸体的同种异体移植物的材料制成。
2.如权利要求1所述的面关节融合塞，其中，在主体的侧表面上存在第二对对置的孔，并且垂直通道与连接第三对孔的第三水平通道相交。
3.如权利要求1所述的面关节融合塞，其中，第二对凸缘部分地围绕主体的外表面的底部。
4.如权利要求2所述的面关节融合塞，其中，第二对凸缘部分地围绕主体的外表面的底部。
5.如权利要求1所述的面关节融合塞，其中，第一和第二水平通道位于平行的水平面上。
6.如权利要求2所述的面关节融合塞，其中，第三水平通道位于第一和第二水平通道之上的平行的水平面上。
7.如权利要求1所述的面关节融合塞，其中，主体由人造成皮质骨制成。
8.如权利要求1所述的面关节融合塞，其中，主体由切割压缩的髂嵴移植物制成。
9.如权利要求1所述的面关节融合塞，其中，主体由尸体的同种异体移植物制成。
10.一种安装于形成面关节的骨之间的孔内的塞，包括：
基本立体截椎体形主体，具有顶表面上的孔，顶表面具有比底表面大的直径；
对置的第一对孔，位于主体的侧表面上，第一对孔由第一水平通道连接；
对置的第二对孔，位于主体的侧表面上，第二对孔由与相对第一水平通道平行的平面内的第二水平通道连接；
垂直通道，从顶表面的孔向下延伸，垂直通道与第一水平通道相交并终止于第二水平通道；
至少一对凸缘，部分地围绕主体的外表面的底部；以及
与骨相适合的人造或生物材料，穿过顶孔并从主体侧表面上的第一和第二对孔排出。
11.如权利要求10所述的一种安装于形成面关节的骨之间的孔内的塞，其中，与垂直通道相交的第三水平通道连接第三对对置的孔，人造或生物材料从第三对孔排出。
12.如权利要求10所述的一种安装于形成面关节的骨之间的孔内的塞，其中设有两对以预定距离间隔的凸缘，部分地围绕主体的外表面的底部。
13.如权利要求10所述的一种安装于形成面关节的骨之间的孔内的塞，其中主体由选自人造皮质骨、切割压缩的髂嵴移植物和尸体的同种异体移植物的材料制成。
14.如权利要求13所述的塞主体，由人造皮质骨制成。
15.如权利要求13所述的塞主体，由切割压缩的髂嵴移植物制成。
16.如权利要求13所述的塞主体，由尸体的髂的同种异体移植物。
17.一种将塞安装于C1-C2和L5-S1面关节中的方法，包括：
在病人患病的或损坏的面关节外面的组织切关节镜形入口；
在形成面关节的两个相对的骨之间形成孔；
将预成形的截椎体塞插入孔，塞具有与孔基本相同的形状；
在塞的顶表面设置孔，顶表面的直径大于底表面直径；
在塞的侧壁上设置至少一对部分地围绕外侧壁的凸缘和至少第一和第二对对置的侧孔，
从顶表面孔向连接第一对孔的第一水平通道和连接第二对孔的第二水平通道设置内皮质孔，
向顶表面上的孔插入施加管；
将与骨相适合的人造或生物材料引入施加管；以及
向人造或生物材料施加足够的压力，以使材料从侧壁孔流出。
18.如权利要求17所述的方法，其中，预成形塞设置为人造皮质骨。
19.如权利要求17所述的方法，其中，预成形塞设置为压缩的髂嵴移植物。
20.如权利要求17所述的方法，其中，预成形塞设置为尸体的同种异体移植物。
21.一种安装在形成面关节的骨之间的孔内的立体塞，包括基本截椎体形主体，具有直径为4至12mm的后端和具有比后端直径小的直径的前端。
CNA200580039815XA 2004-11-22 2005-11-21 最低程度侵入的面关节融合装置的脊椎塞 Pending CN101083958A (zh)

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US20060111782A1 (en) 2006-05-25
WO2006057943A3 (en) 2007-02-01
ZA200703665B (en) 2008-06-25
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US20100222829A1 (en) 2010-09-02
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US20060111779A1 (en) 2006-05-25
US7708761B2 (en) 2010-05-04
WO2006057943A2 (en) 2006-06-01
KR20070088693A (ko) 2007-08-29
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IL182925A0 (en) 2007-09-20
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