CN105997311A - 可调式椎间融合器 - Google Patents
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- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
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- A61F2002/30593—Special structural features of bone or joint prostheses not otherwise provided for hollow
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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Abstract
本发明涉及一种可调式椎间融合器,属医疗器械的人体内置入物技术领域。它包括前部固定结构、后部固定结构、活动结构和固紧结构,活动结构分别置于前部固定结构和后部固定结构的中部,前部固定结构和后部固定结构通过活动结构连接后,还可在植入过程中通过固接结构进一步固紧成一体。本发明可实现融合器在较小的切口或通路下植入椎间隙。具有融合器和所植骨质与椎体表面接触面积大、应力分布广、支撑性强等特点,可用于颈腰椎退行性疾病等病例。解决了目前使用的各种椎间融合器不能在较小的通路下植入,或术后出现融合器移位、脱出、椎体塌陷、所植骨质不愈合率偏高的问题。
Description
技术领域
本发明涉及一种可调式椎间融合器,属医疗器械的人体内置入物技术领域。
背景技术
目前,脊柱融合技术在治疗颈腰痛和颈腰椎不稳方面取得了较好的疗效,是治疗退行性椎间盘疾病、脊柱滑脱、脊柱节段性不稳定的常规术式。近年来,椎间融合器植入术正广泛开展,在临床上获得了一定的满意率,但相应的并发症却不容忽视,如融合器的移位、脱出、塌陷,或椎体塌陷、植骨不愈合,以及因融合器过大而造成植入操作不便利或损伤神经等;有些医生为了提高植骨后获得良好的融合效果,在融合器植入前往椎体间植入大量骨质,但融合器植入后,这些骨质并不能都位于椎体的中间部位而获得较好的植入位置从而提高植骨融合率,而是有相当一部分骨质分散到了椎体的边缘或被挤出椎间隙之外,失去了其应有的支撑与融合作用。有鉴于此,如何能使椎间融合器植入方便、负损伤小,且植入后即能获得较大的植骨容积和较大的支撑面积,还能将所植骨质充分利用,减少植骨浪费,以及能降低融合器植入后的移位、脱出、塌陷或椎体塌陷等并发症,正成为国内外学者们的期待和研究的热点课题。也有学者基于实验分析当融合器的形状类似“十”字形分布时,其应力分布更为均匀,假体脱出的可能性更小,出现椎体塌陷的风险更低,但一体式“十”字形融合器的中部过宽,其植入操作困难,目前市面上也未见到此类产品。
发明内容
本发明的目的在于,针对上述现有技术的不足,提供一种由固定结构、活动结构和固紧结构组成,能在植入过程中通过调节其固紧结构来增加融合器以及所植入的骨质与椎体的接触面积,从而提高其固定与植骨效果的可调式椎间融合器。
本发明是通过如下的技术方案来实现上述目的的:
该可调式椎间融合器包括固定结构、活动结构和固紧结构,其特征在于,固定结构分为前部固定结构和后部固定结构,前部固定结构和后部固定结构之间通过活动结构和固紧结构连接;所述的前部固定结构和/或后部固定结构为一个或多个,所述的固紧结构与固定结构固接成一体或通过组装成一体。
所述的固紧结构为线状、板条状、柱状、卡扣或螺纹套装结构。
当固紧结构为螺纹套装结构时,固定结构的一端装有螺纹套,固定结构的另一端装有与螺纹套相匹配的螺纹杆,通过拧螺纹杆使前部固定结构和后部固定结构相互靠近,与此同时,固定结构之间的活动结构向外张开,所述的前部固定结构和后部固定结构上设有插板和插槽,当通过固紧结构将前部固定结构和后部固定结构联成一体时,插板和插槽内的齿状结构相互咬合在一起,将前部固定结构和后部固定结构进一步固定锁紧。
可选的,所述的固紧结构与固定结构联成一体或通过组装成为一体。
所述的活动结构为连续的板状结构、网格状结构、铰链结构或咬合结构,其活动结构能在植入过程中变形,其板状结构呈弧形、波浪形或直形,其板状结构的厚度为一致或不一致。
所述的前部固定结构和后部固定结构之间可通过医用缝线、金属丝、锚钉、螺钉辅助固定。
所述的固定结构和/或活动结构为非金属材质时,其材料内布设或不布设金属丝状或网状结构加固,其表面布设或不布设金属涂层。
所述的前部固定结构和后部固定结构设有插孔,后部固定结构的插孔为通孔,前部固定结构的插孔为通孔或盲孔;所述的前部固定结构和后部固定结构的插孔相对应。
所述的可调式椎间融合器配备有专设的把持器,把持器由把持器挡板、插杆和把持柄构成,把持器挡板和插杆呈直角连接,把持柄为中空状,术中可从把持柄的中空结构内伸入拧紧工具将固紧结构的螺杆或螺纹套的尾帽拧紧;把持器使用时,把持器的插杆从后部固定结构的插孔插入至前部固定结构的插孔,将前部固定结构和后部固定结构临时把持在一个平面上。
所述的前部固定结构、后部固定结构和/或活动结构与椎板骨质贴附处为平面或弧面;表面可喷涂有诱导骨长入的材料或进行孔隙化、网格化、螺纹化、金属化等处理。
本发明与现有技术相比的有益效果在于:
该可调式椎间融合器由固定结构与活动结构组成,其固定结构可通过活动结构联成一体,其活动结构的形状可在植入过程中进行调节。在植入前,先用专设的把持器的插杆从后部固定结构的插孔插入至前部固定结构,同时将所植骨质置入至插杆和活动结构之间,再将融合器植入至前部固定结构到达合适位置后,取出把持器,同时拧紧固定结构,使前后固定结构固紧成一体;与此同时,所植骨质及活动结构向侧方移动,以扩大椎体中部受力面积,同时也便于在较小的切口或通道内植入。该可调式椎间融合器植入椎间间隙后,其中部横向增宽,能有效提高融合器在椎间的占位面积和植骨容积、能将所植骨质集中在椎间隙的中部,能减小植骨浪费,还能让融合器接近于“十”字形分布,在椎间隙的应力分布更为均匀,融合器和所植骨质与上下椎体表面接触的面积更大,假体脱出的可能性更小,出现椎体塌陷的风险更低。
附图说明
图1为可调式椎间融合器的固定部分为四部分并固紧后的主视图;
图2为可调式椎间融合器的固定部分为四部分的主视图;
图3为可调式椎间融合器的固定部分为三部分并固紧后的主视图;
图4为可调式椎间融合器的活动结构之间通过铰链结构连接并固紧后的主视图;
图5为可调式椎间融合器的活动结构之间通过铰链结构连接的主视图;
图6为可调式椎间融合器的固紧结构为螺纹套装结构的主视图;
图7为可调式椎间融合器的固紧结构为螺纹套装结构的截面主视图;
图8为可调式椎间融合器内装有植骨颗粒的基本结构主视图;
图9为可调式椎间融合器固紧结构固紧后的状态图;
图10为可调式椎间融合器内装有植骨颗粒并固紧后植入完毕的状态图;
图11为插板和插槽上设有齿状结构的示意图;
图12为把持器的主视结构示意图;
图13为把持器的俯视结构示意图;
图14为可调式椎间融合器装有把持器的主视图;
图15为可调式椎间融合器的后部固定结构上制作有插孔的示意图;
图16为可调式椎间融合器的前、后部固定结构的上部、下部制作有活动结构的示意图。
图中:1、前部固定结构,2、后部固定结构,3、活动结构,4、固紧结构,5、插板,6、插槽,7、把持器挡板,8、插杆,9、插孔,10、把持柄。
具体实施方式
该可调式椎间融合器包括固定结构、活动结构3和固紧结构4,固定结构分为前部固定结构1和后部固定结构2,前部固定结构1和后部固定结构2之间通过活动结构3和固紧结构4连接。所述的固紧结构4为线状、板条状、柱状、卡扣或螺纹套装结构。
当固紧结构4为螺纹套装结构时,固定结构的一端装有螺纹套,固定结构的另一端装有与螺纹套相匹配的螺纹杆,通过拧螺纹杆使前部固定结构1和后部固定结构2相互靠近,并将固定结构之间的活动结构向外张开,从而在缩小中部活动结构的长度时,增加了中部活动结构的宽度,使固定结构从近似于长方形变形成类似“十”字形,如此则即扩大了融合器和所植骨质与椎体上下面的接触面积,又使融合器的应力更均匀地分散,提高了其支撑与固定的效果。
所述的前部固定结构1和后部固定结构2上设有插板5和插槽6,当通过固紧结构4将前部固定结构1和后部固定结构2联成一体时,插板5和插槽6内的齿状结构相互咬合在一起,将前部固定结构1和后部固定结构2进一步固定锁紧。
所述的活动结构3为连续的板状结构或铰链结构或咬合结构,其活动结构3能在植入过程中变形。
可选的,所述的活动结构3可位于固定结构的两侧,也可位于固定结构的上部和/或下部,还可与两侧的活动结构同时存在。
所述的前部固定结构1和后部固定结构2之间可通过医用缝线、金属丝、锚钉、螺钉等生物医用材料辅助固定。
所述的齿状结构的方向为一致或不一致;所述的不同固定结构的形状为一致或者不一致;所述同一固定板的高度、厚度为一致或者不一致;所述同一活动结构3的高度、厚度为一致或者不一致;所述不同活动结构3的形状、高度、厚度为一致或者不一致;所述活动结构3的活动板为单层板或双层板、多层板,二板之间有连接板。所述固定结构与活动结构的高度为一致或不一致。
所述的固定结构和/或活动结构3为非金属材质时,其材料内布设或不布设金属丝状或网状结构加固。所述的前部固定结构1和后部固定结构2设有插孔,后部固定结构2的插孔为通孔9,前部固定结构1的插孔为通孔9或盲孔;所述的前部固定结构1和后部固定结构2的插孔相对应。
所述的可调式椎间融合器配备有专设的把持器,把持器由把持器挡板7、插杆8和把持柄10构成,把持器挡板7和插杆8呈直角连接,把持器挡板7上制作有把持柄10;把持柄10为中空状,把持器使用时,把持器的插杆8从后部固定结构2的插孔插入至前部固定结构1的插孔,将前部固定结构1和后部固定结构2临时把持在一个平面上,如此则将前部固定结构1和后部固定结构2临时把持在一个平面上,即便于安装,又便于将活动结构3的植骨临时固定,当前部固定结构1置入到合适位置后,可取出把持器,同时拧紧固定结构,使前部固定结构1和后部固定结构2固紧成一体。
所述的前部固定结构1、后部固定结构2和/或活动结构3与椎板骨质贴附处为平面或弧面;表面可喷涂有诱导骨长入的材料或进行孔隙化、网格化、螺纹化处理。
该可调式椎间融合器植入退变性颈腰椎疾患病人的人体时,先修整椎体终板骨质,试模后用专设把持续器的插杆8从后部固定结构2的插孔插入至前部固定结构1,同时将所植骨质置入至插杆8和活动结构3之间,再将融合器植入至前部固定结构1到达合适位置后,取出把持器8,同时拧紧固紧结构4,使前部固定结构1和后部固定结构2固紧成一体,即完成安装。
该可调式椎间融合器通过活动结构3能实现其在椎间隙内的横向张开,从而扩大了假体和所植骨质与椎体骨质的接触、支撑面积,也让所植入的骨质集中在椎间隙的中部,减少了植骨浪费,提高了植骨融合率,降低了椎体塌陷、假体塌陷的可能性。
可选的,所述的活动结构3可位于固定结构的两侧,也可位于固定结构的上部和/或下部,还可与两侧的活动结构同时存在。当活动结构3位于固定结构的上部和/或下部时,在固紧结构固紧的过程中,其固定结构的上部和/或下部的活动结构能向上和/或向下张开,以与椎体中间凹、周边凸的解剖结构相适应,并进一步降低了植入后融合器脱出的风险。
以上所述只是本发明的较佳实施例而已,上述举例说明不对本发明的实质内容作任何形式上的限制,所属技术领域的普通技术人员在阅读了本说明书后依据本发明的技术实质对以上具体实施方式所作的任何简单修改或变形,以及可能利用上述揭示的技术内容加以变更或修饰为等同变化的等效实施例,均仍属于本发明技术方案的范围内,而不背离本发明的实质和范围。
Claims (10)
1.一种可调式椎间融合器,包括固定结构、活动结构(3)和固紧结构(4),其特征在于,固定结构分为前部固定结构(1)和后部固定结构(2),前部固定结构(1)和后部固定结构(2)之间通过活动结构(3)和固紧结构(4)连接,所述的前部固定结构(1)和/或后部固定结构(2)为一个或多个。
2.所述的固紧结构与固定结构固接成一体或通过组装成一体
根据权利要求1所述的一种可调式椎间融合器,其特征在于,所述的固紧结构(4)为线状、板条状、柱状、卡扣或螺纹套装结构。
3.根据权利要求1或2所述的一种可调式椎间融合器,其特征在于,所述的固紧结构(4)为螺纹套装结构时,固定结构的一端装有螺纹套,固定结构的另一端装有与螺纹套相匹配的螺纹杆,通过拧螺纹杆使前部固定结构(1)和后部固定结构(2)相互靠近,并将固定结构之间的活动结构(3)向外张开,所述的前部固定结构(1)和后部固定结构(2)上设有插板(5)和插槽(6),当通过固紧结构(4)将前部固定结构(1)和后部固定结构(2)联成一体时,插板(5)和插槽(6)内的齿状结构相互咬合在一起,将前部固定结构(1)和后部固定结构(2)进一步固定锁紧。
4.根据权利要求1所述的一种可调式椎间融合器,其特征在于,所述的活动结构(3)为连续的板状结构、网格状结构、铰链结构或咬合结构,其活动结构(3)能在植入过程中变形;其板状结构呈弧形、波浪形或直形;活动结构(3)位于固定结构的两侧,或位于固定结构的上部和/或下部,还可固定结构的上部和/或下部的活动结构与两侧的活动结构同时存在。
5.根据权利要求1所述的一种可调式椎间融合器,其特征在于,所述的前部固定结构(1)和后部固定结构(2)之间可通过医用缝线、金属丝、锚钉或螺钉等生物医用材料辅助固定。
6.根据权利要求1所述的一种可调式椎间融合器,其特征在于,所述的固定结构和/或活动结构(3)为非金属材质时,其材料内布设或不布设金属丝状或网状结构加固;其表面布设或不布设金属涂层。
7.根据权利要求1所述的一种可调式椎间融合器,其特征在于,所述的前部固定结构(1)和后部固定结构(2)设有插孔,后部固定结构(2)的插孔为通孔(9),前部固定结构(1)的插孔为通孔(9)或盲孔;所述的前部固定结构(1)和后部固定结构(2)的插孔相对应。
8.根据权利要求1所述的一种可调式椎间融合器,其特征在于,所述的可调式椎间融合器配备有专设的把持器,把持器有把持器挡板(7)、插杆(8)和把持柄(10)构成,把持器挡板(7)和插杆(8)呈直角连接,把持柄(10)为中空状;把持器使用时,把持器的插杆(8)从后部固定结构(2)的插孔插入至前部固定结构(1)的插孔,将前部固定结构(1)和后部固定结构(2)临时把持在一个平面上。
9.根据权利要求1所述的一种可调式椎间融合器,其特征在于,所述的前部固定结构(1)、后部固定结构(2)和/或活动结构(3)与椎板骨质贴附处为平面或弧面;表面可喷涂有诱导骨长入的材料或进行孔隙化、网格化、螺纹化、金属化处理。
10.所述的齿状结构的方向为一致或不一致;所述的不同固定结构的形状为一致或者不一致;所述的同一固定板的高度、厚度为一致或者不一致;所述的同一活动结构3的高度、厚度为一致或者不一致;所述的不同活动结构3的形状、高度、厚度为一致或者不一致;所述的活动结构3的活动板为单层板或双层板、多层板,二板之间有连接板;所述的固定结构与活动结构的高度为一致或不一致。
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