CN114099089A - 一种椎间融合器 - Google Patents

一种椎间融合器 Download PDF

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CN114099089A
CN114099089A CN202010885444.3A CN202010885444A CN114099089A CN 114099089 A CN114099089 A CN 114099089A CN 202010885444 A CN202010885444 A CN 202010885444A CN 114099089 A CN114099089 A CN 114099089A
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China
Prior art keywords
cage
intervertebral
fusion cage
aperture
region
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张靖
徐凯
文晓宇
孙陆
马学为
刘昊
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Zhisu Health Technology Jiaxing Co ltd
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Beijing Zhisu Health Technology Co ltd
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Priority to CN202010885444.3A priority Critical patent/CN114099089A/zh
Priority to PCT/CN2021/104203 priority patent/WO2022042031A1/zh
Priority to US18/024,001 priority patent/US20230263639A1/en
Publication of CN114099089A publication Critical patent/CN114099089A/zh
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Abstract

本发明提供了一种椎间融合器，所述椎间融合器上设置有填料孔，所述填料孔贯穿所述椎间融合器两端，所述椎间融合器的侧面上设置有具有间隔的多个孔隙区域。通过对孔隙结构区域的合理布局，将相邻孔隙区域之间设置间隔，以使椎间融合器在具有预定弹性模量的条件下，可以确保椎间融合器具有足够的强度以免在受到外力时断裂，甚至碎裂。有助于解决现有技术中椎间融合器由于孔隙结构导致强度不足的技术问题。

Description

一种椎间融合器
技术领域
本发明涉及医疗器械领域，尤其是指一种椎间融合器。
背景技术
目前，椎间融合器是应用于人上下椎骨之间的一种植入性医疗器械，是实现脊柱相邻椎骨间隙融合的主要植入物之一，其安全性和有效性直接影响相邻椎体骨性融合的效果。由于每个人的个体情况不同(比如骨密度，植入时相邻椎骨的位置和结构等)，所以需要不同弹性模量的医疗器械，只有当椎间融合器的弹性模量接近人的骨弹性模量时，才可以避免发生应力遮挡等问题，所以为了可以使椎间融合器的弹性模量与对应的骨弹性模量一致，往往通过一些孔隙结构使椎间融合器具有预期的弹性模量。
但是，现有技术中由于孔隙区域布置的不合理性，导致椎间融合器的强度往往不足。在某些情况下，比如椎间融合器植入人体后，人体在运动过程中，椎骨会对椎间融合器产生外力作用，进而可能会导致强度不足的椎间融合器产生断裂，甚至彻底碎裂，断裂或破碎后椎间融合器碎片如果遗留在人体内会非常危险。
所以研发人员正在寻找一种椎间融合器，用于解决在具有孔隙区域以所需弹性模量的情况下，可以同时确保椎间融合器的强度，防止椎间融合器在受到外力作用下产生断裂，甚至碎裂，有助于解决现有技术中椎间融合器由于孔隙区域导致椎间融合器强度不足的技术问题。
发明内容
本申请提供了一种椎间融合器，其目的在于通过孔隙区域的合理布局，获得可以同时获得所需弹性模量的条件下，并得到符合要求的强度，以防止椎间融合器在受到外力作用下产生断裂，甚至碎裂。
所述椎间融合器上设置有填料孔，所述填料孔贯穿所述椎间融合器两端；
所述椎间融合器的侧面上设置有具有间隔的多个孔隙区域。
在一实施例中，所述椎间融合器的所述两端分别为第一端面和第二端面；
其中至少一个所述孔隙区域向所述两端延伸，并分别与所述第一端面和第二端面相接。
在一实施例中，所述侧面由第一侧面和第二侧面，以及第三侧面和第四侧面依次相接围合而成；
所述多个孔隙区域包括第一孔隙区域和第二孔隙区域；
所述第一孔隙区域和第二孔隙区域分别设置在所述第一侧面和所述第二侧面上。
在一实施例中，所述第二侧面上设置有器械孔。
在一实施例中，所述多个孔隙区域还包括第三孔隙区域；
所述第三孔隙区域设置在所述第四侧面上。
在一实施例中，所述第一侧面和第二侧面，以及第三侧面和第四侧面之间通过圆角过渡。
在一实施例中，所述第一端面和所述第二端面之间具有倾斜夹角。
在一实施例中，所述第一端面和/或所述第二端面上分别设置有第一突起和第二突起。
在一实施例中，所述第一侧面和所述第三侧面之间具有侧面夹角。
在一实施例中，所述孔隙区域为由连杆支撑建构的具有孔隙的晶体结构区域。
如上可见，基于上述实施例，本申请提供了一种椎间融合器，通过对孔隙结构区域的合理布局，使椎间融合器在具有预定弹性模量的条件下，可以确保椎间融合器具有足够的强度，以免在受到外力时断裂，甚至碎裂。有助于解决现有技术中椎间融合器由于孔隙结构导致强度不足的技术问题。
附图说明
图1为本发明椎间融合器一实施例中整体结构示意图；
图2为本发明椎间融合器另一实施例中整体结构示意图；
图3为椎间融合器的孔隙区域布局状态100的应力分析图；
图4为椎间融合器的孔隙区域布局状态200的应力分析图；
图5为本发明椎间融合器一侧结构的侧视图示意图；
图6为本发明椎间融合器结构的主视图示意图；
图7为本发明椎间融合器背面的后视图示意图；
图8为本发明椎间融合器第一端面和第二端面位置关系及结构示意图；
图9为本发明椎间融合器结构的俯视图。
附图标记：
1 椎间融合器
11 填料孔
12 侧面
121 第一侧面
122 第二侧面
123 第三侧面
124 第四侧面
13 间隔
14 孔隙区域
141 第一孔隙区域
142 第二孔隙区域
15 第一端面
151 第一突起
16 第二端面
161 第二突起
17 器械孔
171 器械槽
18 圆角
a 倾斜夹角
b 侧面夹角
具体实施方式
为使本发明的目的、技术方案及优点更加清楚明白，以下参照附图并举实施例，对本发明进一步详细说明。
图1为本发明椎间融合器一实施例中整体结构示意图，图2为本发明椎间融合器另一实施例中整体结构示意图，图3为椎间融合器的孔隙区域布局状态100的应力分析图，图4为椎间融合器的孔隙区域布局状态200的应力分析图。如图1和图2，图3和图4所示，在一实施例中，本申请提供了一种椎间融合器，椎间融合器1上设置有填料孔11，填料孔11贯穿椎间融合器1两端；
椎间融合器1的侧面12上设置有具有间隔13的多个孔隙区域14。
在本实施例中提供了一种椎间融合器1的具体结构，在本实施例中椎间融合器1以六面体结构为例，所述两端可以理解为所述六面体结构其中两个相对面，从所述两端贯穿填料孔11，用于填入相应材料帮助人体组织的依附性生长。在临床操作中，所述两端分别会支撑上下方向的椎骨，所以所述六面体结构下的所述两端的端面不能设置孔隙区域14，以免在上下椎骨的挤压下，使所述两端的端面破裂。孔隙区域14为多个并围绕着椎间融合器1的侧面12布置，相邻的孔隙区域14之间应具有间隔13，以确保椎间融合器1侧面12的强度。需要指出的是椎间融合器1为六面体结构是为了更好说明本实施例的举例，并非是对本实施例的限定。
椎间融合器1为一体成型，可以采用3D打印的方式制作，其材质采用钛合金。目前，临床应用较多的是聚醚醚酮(PEEK)材料，然而PEEK作为融合器的制作材料不具有生物活性，与上下软骨终板不能实现真正的融合，大多数表面被纤维组织覆盖，容易产生微动，进而影响椎体间的生物力学稳定性，即会导致整体结构的稳定性得不到保证，钛合金椎间融合器具有较好的生物相容性和支撑强度。
在临床中，多孔型椎间融合器的压缩刚度应接近人体骨骼的刚度，减少应力遮挡作用，刚度为30000-100000N/mm。
椎间融合器1可以还可以采用所述六面体结构中的长方体结构，高度范围优选在6-10mm，长度范围优选在14-16mm，宽度范围12-14mm。
图3和图4的固定位置均为底端，受力均从上端施加以模拟真实的椎骨受力情况。最终图3为本申请中具有间隔13结构的受力情况，在外部其他条件均一致的情况下，图3最大应力值为122MPa，图4最大应力值为973MPa，由此可见，本申请中因为孔隙区域14的合理布局，使椎间融合器1承受的最大应力大幅减小。
图5为本发明椎间融合器一侧结构的侧视图示意图，图6为本发明椎间融合器结构的主视图示意图。如图5和图6所示，在另一实施例中，椎间融合器1的所述两端分别为第一端面15和第二端面16；
其中至少一个孔隙区域14向所述两端延伸，并分别与第一端面15和第二端面16相接。
在本实施例中提供了一种所述两端的具体结构，并且进一步公开了孔隙区域14与所述两端的布置关系。孔隙区域14沿椎间融合器1的周圈布置，间隔13为多个孔隙区域14沿侧面12的围绕方向布置，在本实施例中公开了对于孔隙区域14而言，与所述两端，即第一端面15和第二端面1 6之间的布置方式，因为椎间融合器1的弹性模量主要是指第一端面15和第二端面16分别与椎骨接触后，向椎间融合器1挤压受力时对所述椎骨反作用所需要的弹性模量，所以为了使孔隙区域14为第一端面15和第二端面16之间提供最大的弹性模量调整幅度。
在一实施例中，侧面12由第一侧面121和第二侧面122，以及第三侧面123和第四侧面124依次相接围合而成；
多个孔隙区域14包括第一孔隙区域141和第二孔隙区域142；
第一孔隙区域141和第二孔隙区域142分别设置在第一侧面121和第二侧面123上。
在本实施例中具体提供了一种椎间融合器1上孔隙区域14的布置方式。为了更好的解释本实施例，以所述六面体结构为例，所述六面体结构的侧面12包括上述的四个侧面，也可以理解为第一侧面121为左侧面，第二侧面122为背面，第三侧面123为右侧面，第四侧面124为正面。在本实施例中所述左侧面和所述右侧面上分别设置有第一孔隙区域141和第二孔隙区域142，间隔13可以理解为第一孔隙区域141和第二孔隙区域142之间的区域，另外，第一孔隙区域141和第二孔隙区域142也并非将整个所述左侧面和所述右侧面全部占满。
图7为本发明椎间融合器背面的后视图示意图。如图7所示，在一实施例中，第二侧面122上设置有器械孔17。
在本实施例中提供了在第二侧面122上设置器械孔17的具体实施方式，器械孔17周围还设置有器械槽171，器械孔17以及器械槽171都是为了更好对接外部器械，所述外部器械用于将椎间融合器1放置于上下所述椎骨之间。器械孔17也设置于椎间融合器1的侧面12上，具体地，设置于第二侧面122上，器械孔17朝向填料孔11设置，以使所述椎间融合器1的外部与填料孔11连通，即背面上。另外，所述器械孔17多为螺纹孔，以便更好地与所述外部器械连接。所述螺纹孔虽然可以很好地与所述外部器械连接，但是这种结构会导致所述螺纹孔的应力集中，在受到外力挤压后很容易碎裂。尤其是当器械孔17周围布置有孔隙区域14后，孔隙区域14在植入人体后经常会受到上下端的压力，孔隙区域14会产生一定的形变，这样的形变会使应力集中的所述螺纹孔破裂。本实施例中由于器械孔17左右与孔隙区域14之间都具有很大的距离，单独设置在所述背面上，因此孔隙区域14将对器械孔17不造成应力集中的影响，另外当孔隙区域14受到外力产生形变时对器械孔17的影响也会大幅降低。另外，第二侧面122可以为外突曲面。
在一实施例中，多个孔隙区域14还包括第三孔隙区域143；
第三孔隙区域143设置在第四侧面124上。
在本实施例中还提供了一种第三孔隙区域143设置在第四侧面124上的具体实施方式，即第三孔隙区域143设置在所述正面，第三孔隙区域143的布置方式与第一孔隙区域141和第二孔隙区域142类似，都可以延伸至第一端面15和第二端面16。本实施方式可以进一步的使椎间融合器1的弹性模量实现调整，而不只局限于通过第一孔隙区域141和第二孔隙区域142的布置实现调整。
在一实施例中，第一侧面121和第二侧面122，以及第三侧面123和第四侧面124之间通过圆角18过渡。
在本实施例中提供了一种第一侧面121和第二侧面122，以及第三侧面123和第四侧面124之间通过圆角18过渡的具体实施方式。在本实施例中可以将圆角18作为间隔13进行设计，这样可以使孔隙区域14沿椎间融合器1周圈方向可以能够更长的进行延展，另外还可以布置有间隔13，进而使椎间融合器1的结构更加紧凑。另外圆角18的设计也避免了应力的集中，毕竟圆角18的两侧会与孔隙区域14相接，如果孔隙区域14产生形变必然会对圆角18产生影响。
图8为本发明椎间融合器第一端面和第二端面位置关系及结构示意图。如图8所示，在一实施例中，第一端面15第二端面16间具有倾斜夹角a。
在本实施例中提供了第一端面15第二端面16间具有倾斜夹角a的具体实施方式，因为第一端面15和第二端面16分别与上、下椎骨贴合，而所有椎骨排列后会具有生理曲度，椎间融合器1置于上、下椎骨之间，第一端面15和第二端面16的倾斜夹角a便可以从结构上使第一端面15和第二端面16与上、下椎骨贴合形成生理曲度。倾斜夹角a优选地度数为0至7度。
在一实施例中，第一端面15和/或第二端面16上分别设置有第一突起151和第二突起161。
在本实施例中提供了一种在第一端面15和/或第二端面16分别设置第一突起151和第二突起161。第一突起151和第二突起161用于与椎骨之间的接合，有助于减小椎间融合器1在上、下的椎骨之间的移动。
图9为本发明椎间融合器结构的俯视图。如图9所示，在一实施例中，第一侧面121和第三侧面123之间具有侧面夹角b。
在本实施例中提供了一种第一侧面121和第三侧面123具有侧面夹角b的具体实施方式，以使椎间融合器1更加符合椎骨的形态。
在一实施例中，孔隙区域14为由连杆支撑建构的具有孔隙的晶体结构区域。
在本实施例中提供了一种孔隙区域14的具体结构。孔隙区域14为通过多根连杆144构建的具有孔隙145的所述晶体结构区域，连杆144的杆径优选为100～800μm。在多根连杆144两端相互连接构建的所述晶体结构区域中，连杆144构建所述晶体结构区域后其相互之间的孔隙145可以通过内切球体进行度量，而所述球体的直径，即孔径，优选地，所述孔径为100～800μm，所述孔隙的总空间占孔隙区域14总空间比率称之为孔隙率，优选地，孔隙率为5％～90％。
将所述杆径和所述孔径，以及所述孔隙率按照预期的弹性模量进行组合后得到孔隙区域14最终的弹性模量。
需要指出的是第一孔隙区域141和第二孔隙区域142，以及第三孔隙区域143都可以分别理解为不同所述杆径的连杆144相互连接构建的空间结构，以获得不同弹性模量的孔隙区域。同理，也可以通过调节所述孔径和所述孔隙率获得不同弹性模量的孔隙区域。
仅为本发明的较佳实施例而已，并不用以限制本发明，凡在本发明的精神和原则之内，所做的任何修改、等同替换、改进等，均应包含在本发明保护的范围之内。

Claims (10)

1.一种椎间融合器，其特征在于，所述椎间融合器(1)上设置有填料孔(11)，所述填料孔(11)贯穿所述椎间融合器(1)两端；
所述椎间融合器(1)的侧面(12)上设置有具有间隔(13)的多个孔隙区域(14)。
2.根据权利要求1所述的椎间融合器，其特征在于，所述椎间融合器(1)的所述两端分别为第一端面(15)和第二端面(16)；
其中至少一个所述孔隙区域(14)向所述两端延伸，并分别与所述第一端面(15)和第二端面(16)相接。
3.根据权利要求1或2所述的椎间融合器，其特征在于，所述侧面(12)由第一侧面(121)和第二侧面(122)，以及第三侧面(123)和第四侧面(124)依次相接围合而成；
所述多个孔隙区域(14)包括第一孔隙区域(141)和第二孔隙区域(142)；
所述第一孔隙区域(141)和第二孔隙区域(142)分别设置在所述第一侧面(121)和所述第二侧面(123)上。
4.根据权利要求3所述的椎间融合器，其特征在于，所述第二侧面(122)上设置有器械孔(17)。
5.根据权利要求4所述的椎间融合器，其特征在于，所述多个孔隙区域(14)还包括第三孔隙区域(143)；
所述第三孔隙区域(143)设置在所述第四侧面(124)上。
6.根据权利要求3所述的椎间融合器，其特征在于，所述第一侧面(121)和第二侧面(122)，以及第三侧面(123)和第四侧面(124)之间通过圆角(18)过渡。
7.根据权利要求2所述的椎间融合器，其特征在于，所述第一端面(15)和所述第二端面(16)之间具有倾斜夹角(a)。
8.根据权利要求1所述的椎间融合器，其特征在于，所述第一端面(15)和/或所述第二端面(16)上分别设置有第一突起(151)和第二突起(161)。
9.根据权利要求1所述的椎间融合器，其特征在于，所述第一侧面(121)和所述第三侧面(123)之间具有侧面夹角(b)。
10.根据权利要求1所述的椎间融合器，其特征在于，所述孔隙区域(14)为由连杆支撑建构的具有孔隙的晶体结构区域。
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