CN110169847A - 一种组织工程颈椎椎间融合器及使用方法 - Google Patents
一种组织工程颈椎椎间融合器及使用方法 Download PDFInfo
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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
本发明公开了一种组织工程颈椎椎间融合器及使用方法,融合器包括融合器本体,融合器本体的内部穿设有用于插入椎体内起固定作用的柱栓,柱栓自锁于融合器本体的内部,融合器本体一端面内开设有用于调节柱栓的调节孔;融合器本体和柱栓是用可吸收医用高分子材料3D打印成型的多孔支架;本发明具有良好的成骨性,便于实现椎间的骨性愈合;安装牢靠稳定,具有自锁功能,安装过程不需要做颈前路固定;安装过程后可以不留异物于体内,为椎体的融合提供稳定的环境,具有良好的融合质量和远期效果;对影像学评估无影响。
Description
技术领域
本发明涉及一种组织工程骨领域,具体涉及一种组织工程颈椎椎间融合器及使用方法。
背景技术
椎间融合作为一种处理脊柱疾病、创伤的治疗方法已有数十年的历史,早期椎间融合的概念为大量肌肉的剥离、足量自体骨移植、长期绝对卧床休息。由于椎间融合重建了脊柱的前、中柱,大大提高了脊柱退行性病变、创伤的治疗效果,使椎间融合术在短时间内得到广泛运用,可以说椎间融合是脊柱外科史上的一个里程碑。虽然传统自体髂骨移植愈合率髙,但其并发症却是一个不能忽视的问题,文献报道自体髂骨植骨并发症的发生率为25.3%,如增加失血量,血肿、供骨区疼痛、髂骨骨折、股部感觉异常等,而且自体髂骨常因强度不足而塌陷,导致椎间高度的丢失,直接影响椎管容积的大小和减压效果。
1979年Bagby将一不锈钢中空带孔柱状体(内填塞减压时切除的骨碎片)代替髂骨块用于马的颈椎椎间融合术,称Bagby笼。1988年Bagby首次将一种不锈钢中空状“篮子”应用于临床,用来装载移植骨进行腰椎椎间融合治疗椎间盘源性下腰痛,取得非常大的成功。1991年,Brantigan和Stsffee将自体松质骨装入强化碳素纤维立方框架式融合器中进行椎间融合获得成功。椎间融合器通过撑开椎间隙,恢复纤维环,脊柱前、后纵韧带,肌肉及关节囊的张力,即“撑开-压缩张力带”效应使脊柱获得即刻稳定,为植骨融合、重建脊柱序列创造条件。
椎间融合器经过几十年的发展,目前临床运用比较广泛的椎间融合器的材质尤以金属和碳纤维为主,随着时间的推移,现有椎间融合器的不足之处也就越来越明显:
金属材料椎间融合器,与人体骨的组织相容性差,关节成型手术中界面间的微动以及产生微屑不可避免,界面松动最终可造成植骨融合失败,骨不连及长期疼痛;金属椎间融合器的弹性模量过高,钛金属椎间融合器弹性模量约为110GPa,与人体椎骨弹性模量(皮质骨弹性模2.4GPa,松质骨弹性模量2.1GPa)不匹配,产生应力遮挡效应,后期相邻椎体骨质疏松、导致融合器下沉,椎间高度丢失,从而影响融合质量和远期效果;此外金属材料椎间融合器的一个明显缺点就是其影响放射学检査,术后对植骨融合效果的判断只能通过动态摄影,而无法直接观察到,对骨融合情况无法判定。
碳纤维材料椎间融器,脆性较大容易造成装置的破坏,进而引起组织学反应;碳纤维的分离会造成关节内污染、滑膜炎、淋巴节扩散。
综上可知,现有技术中的椎间融合器从生物力学和生理学的角度来考虑,都不理想,并没有完美的解决方式,这个技术难题一直困扰着本领域的技术人员。
发明内容
本发明要解决的技术问题是针对以上不足,提供一种组织工程颈椎椎间融合器及使用方法,可以具有良好的成骨性,便于实现椎间的骨性愈合;安装牢靠稳定,具有自锁功能,安装过程不需要做颈前路固定;安装过程后可以不留异物于体内,为椎体的融合提供稳定的环境,具有良好的融合质量和远期效果;对影像学评估无影响。
为解决以上技术问题,本发明采用以下技术方案:
一种组织工程颈椎椎间融合器,包括融合器本体,融合器本体的内部穿设有用于插入椎体内起固定作用的柱栓,柱栓自锁于融合器本体的内部;所述融合器本体一端面内开设有用于调节柱栓的调节孔。
进一步地,所述融合器本体和柱栓是用可吸收医用高分子材料3D打印成型的多孔支架。
进一步地,所述融合器本体的外形为楔形结构,融合器本体包括前端面和后端面,前端面的高度大于后端面的高度,前端面内部开设有调节孔,调节孔从前端面水平延伸至融合器本体的内部,调节孔由上下两部分组成,上部孔的截面为三角形与半圆形的组合,下部孔为方形结构。
进一步地,所述融合器本体的上端面开设有竖直的圆形安装孔,融合器本体的下端面开设有竖直的装配孔,装配孔由中间的圆柱孔以及圆柱孔两侧的半圆柱孔组成;装配孔中间圆柱孔的中心线与安装孔的中心线共线。
进一步地,所述调节孔开口处的顶部设有一个方形结构的把持槽;所述融合器本体的前端面上还开设有两个对称分布的把持孔。
进一步地,所述融合器本体上端面边缘处设有一个垂直的定位凸起。
进一步地,所述柱栓的主体呈圆柱体结构,圆柱体的下端部外侧设有两个对称分布的柱形凸起;所述柱栓的顶部为半球体。
一种组织工程颈椎椎间融合器的使用方法,包括以下步骤:
步骤一:用可吸收医用高分子材料根据预先设置好的规格型号3D打印成融合器本体和柱栓的多孔支架,向支架内载入诱导骨再生或者软骨再生的基质材料;通过合适方式使支架产生适合骨细胞长入的微孔;取病人骨髓基质干细胞载入支架内进行干细胞诱导培养;无论进行骨诱导还是软骨诱导培养的融合器放入椎间隙都会向骨的方向生长;
步骤二:通过器械在预安装椎间融合器位置处的相邻一侧椎体上,加工一个凹槽及一个孔洞,凹槽的位置以及形状与定位凸起相适配,孔洞的位置以及形状与柱栓的上部相适配;
步骤三:将柱栓通过装配孔装配至融合器本体的内部;
步骤四:通过颈椎撑开器将椎间隙撑开,把持器在把持孔和把持槽的配合下将装配好的融合器本体和柱栓抓紧,然后送至需安装椎间融合器位置处进行安装,安装时定位凸起与椎体上预制的凹槽相配合;
步骤五:通过器械将融合器本体内的柱栓向预制椎体孔洞推送,推送过程中柱栓顶端的半球部分以及上部主体插至预制的孔洞内,当栓柱的底面推送至调节孔中部平台平面以上时;再通过器械将柱栓沿柱栓主体的中轴线在调节孔内顺时针或逆时针转动90°,柱栓的柱形凸起卡紧于调节孔的平台上,柱栓自锁于融合器本体内;完成椎间融合器的安装工作。
本发明采用以上技术方案后,与现有技术相比,具有以下优点:
本发明提供的一种组织工程颈椎椎间融合器及使用方法,通过干细胞成骨技术,做成组织工程颈椎椎间融合器,其具有良好的成骨性,便于实现椎间的骨性愈合,实现脊柱本身的骨性愈合,手术后期不会出现脊柱椎间高度丢失或脊柱不稳定的问题,这一点是金属材料或碳纤维材料椎间融器不能相提并论的;
通过融合器本体和柱栓完美的自锁配合,使得融合器牢靠稳定,且安装过程不需要做颈前路固定,不会对颈前路组织有压迫感,不会引起病人不适;
本发明的椎间融合器可以随着椎间骨性愈合可进行降解吸收,最终不留异物于体内,为椎体的融合提供稳定的环境,具有良好的融合质量和远期效果;
本发明的椎间融合器对影像学评估无影响,不会影响X线平片、CT、MRI对骨融合情况的判断。
下面结合附图和实施例对本发明进行详细说明。
附图说明
图1是本发明的结构示意图;
图2是本发明中融合器本体的结构示意图;
图3是本发明中融合器本体的另一结构示意图;
图4是图2融合器本体的主视图;
图5是图4中A-A部的剖视图;
图6是图2融合器本体的俯视图;
图7是图2融合器本体的左视图;
图8是本发明中柱栓的结构示意图;
图中,
1-融合器本体,101-前端面,102-后端面,103-调节孔,104-把持槽,105-把持孔,106-装配孔,107-安装孔,108-定位凸起,2-柱栓,201-半球体,202-柱形凸起。
具体实施方式
为了对本发明的技术特征、目的和效果有更加清楚的理解,现对照附图说明本发明的具体实施方式。
实施例1一种组织工程颈椎椎间融合器
如图1-8共同所示,本发明提供一种组织工程颈椎椎间融合器,包括融合器本体1,融合器本体1的内部穿设有用于插入椎体内起固定作用的柱栓2,柱栓2自锁于融合器本体1的内部;所述融合器本体1和柱栓2是用可吸收医用高分子材料3D打印成型的多孔支架。
所述融合器本体1的外形为适合颈椎角度的楔形结构,融合器本体1包括前端面101和后端面102,前端面101的高度大于后端面102的高度;所述前端面101内部开设有调节孔103,调节孔103从前端面101水平延伸至融合器本体1的内部,调节孔103由上下两部分组成,上部孔的截面为三角形与半圆形的组合,下部孔为方形结构;所述融合器本体1的上端面开设有竖直的圆形安装孔107,融合器本体1的下端面开设有竖直的装配孔106,装配孔106由中间的圆柱孔以及圆柱孔两侧的半圆柱孔组成,装配孔106中间圆柱孔的中心线与安装孔107的中心线共线;安装孔107与装配孔106分别与调节孔103相连通;所述调节孔103开口处的顶部设有一个方形结构的把持槽104;所述前端面101上还开设有两个对称分布的把持孔105,把持孔105为圆形的盲孔结构;所述融合器本体1上端面边缘处设有一个垂直的定位凸起108,定位凸起108呈方柱结构,起定位防旋作用。
所述柱栓2的主体呈圆柱体结构,圆柱体的下端部外侧设有两个对称分布的柱形凸起202,柱形凸起202可以与融合器本体1内的装配孔106进行间隙配合;所述柱栓2的顶部为半球体201,半球体201便于柱栓2与融合器本体1的装配;所述柱栓2的圆柱形主体与安装孔107进行间隙配合。
实施例2一种组织工程颈椎椎间融合器的使用方法
包括以下步骤:
步骤一:用可吸收医用高分子材料根据预先设置好的规格型号3D打印成融合器本体1和柱栓2的多孔支架,向支架内载入诱导骨再生或者软骨再生的基质材料;通过合适方式使支架产生适合骨细胞长入的微孔;取病人骨髓基质干细胞载入支架内进行干细胞诱导培养;无论进行骨诱导还是软骨诱导培养的融合器放入椎间隙都会向骨的方向生长。
步骤二:通过器械在预安装椎间融合器位置处的相邻一侧椎体上,加工一个凹槽及一个孔洞,凹槽的位置以及形状与定位凸起108相适配,孔洞的位置以及形状与柱栓2的上部相适配;
步骤三:将柱栓2通过装配孔106装配至融合器本体1的内部;
步骤四:通过颈椎撑开器将椎间隙撑开,把持器在把持孔105和把持槽104的配合下将装配好的融合器本体1和柱栓2抓紧,然后送至需安装椎间融合器位置处进行安装,安装时定位凸起108与椎体上预制的凹槽相配合;
步骤五:通过器械将融合器本体1内的柱栓2向预制椎体孔洞推送,推送过程中柱栓2顶端的半球部分201以及上部主体插至预制的孔洞内,当栓柱2的底面推送至调节孔103中部平台平面以上时;再通过器械将柱栓2沿柱栓2主体的中轴线在调节孔103内顺时针或逆时针转动90°,柱栓2的柱形凸起202卡紧于调节孔103的平台上,柱栓2自锁于融合器本体1内;完成椎间融合器的安装工作。
以上所述为本发明最佳实施方式的举例,其中未详细述及的部分均为本领域普通技术人员的公知常识。本发明的保护范围以权利要求的内容为准,任何基于本发明的技术启示而进行的等效变换,也在本发明的保护范围之内。
Claims (8)
1.一种组织工程颈椎椎间融合器,其特征在于:包括融合器本体(1),融合器本体(1)的内部穿设有用于插入椎体内起固定作用的柱栓(2),柱栓(2)自锁于融合器本体(1)的内部;所述融合器本体(1)一端面内开设有用于调节柱栓(2)的调节孔(103)。
2.如权利要求1所述的一种组织工程颈椎椎间融合器,其特征在于:所述融合器本体(1)和柱栓(2)是用可吸收医用高分子材料3D打印成型的多孔支架。
3.如权利要求1所述的一种组织工程颈椎椎间融合器,其特征在于:所述融合器本体(1)的外形为楔形结构,融合器本体(1)包括前端面(101)和后端面(102),前端面(101)的高度大于后端面102的高度,前端面(101)内部开设有调节孔(103),调节孔(103)从前端面(101)水平延伸至融合器本体(1)的内部,调节孔(103)由上下两部分组成,上部孔的截面为三角形与半圆形的组合,下部孔为方形结构。
4.如权利要求1所述的一种组织工程颈椎椎间融合器,其特征在于:所述融合器本体(1)的上端面开设有竖直的圆形安装孔(107),融合器本体(1)的下端面开设有竖直的装配孔(106),装配孔(106)由中间的圆柱孔以及圆柱孔两侧的半圆柱孔组成;装配孔(106)中间圆柱孔的中心线与安装孔(107)的中心线共线。
5.如权利要求1所述的一种组织工程颈椎椎间融合器,其特征在于:所述调节孔(103)开口处的顶部设有一个方形结构的把持槽(104);所述融合器本体(1)的前端面(101)上还开设有两个对称分布的把持孔(105)。
6.如权利要求1所述的一种组织工程颈椎椎间融合器,其特征在于:所述融合器本体(1)上端面边缘处设有一个垂直的定位凸起(108)。
7.如权利要求1所述的一种组织工程颈椎椎间融合器,其特征在于:所述柱栓(2)的主体呈圆柱体结构,圆柱体的下端部外侧设有两个对称分布的柱形凸起(202);所述柱栓(2)的顶部为半球体(201)。
8.一种组织工程颈椎椎间融合器的使用方法,其特征在于:包括以下步骤:
步骤一:用可吸收医用高分子材料根据预先设置好的规格型号3D打印成融合器本体(1)和柱栓(2)的多孔支架,向支架内载入诱导骨再生或者软骨再生的基质材料;通过合适方式使支架产生适合骨细胞长入的微孔;取病人骨髓基质干细胞载入支架内进行干细胞诱导培养;无论进行骨诱导还是软骨诱导培养的融合器放入椎间隙都会向骨的方向生长;
步骤二:通过器械在预安装椎间融合器位置处的相邻一侧椎体上,加工一个凹槽及一个孔洞,凹槽的位置以及形状与定位凸起(108)相适配,孔洞的位置以及形状与柱栓(2)的上部相适配;
步骤三:将柱栓(2)通过装配孔(106)装配至融合器本体(1)的内部;
步骤四:通过颈椎撑开器将椎间隙撑开,把持器在把持孔(105)和把持槽(104)的配合下将装配好的融合器本体(1)和柱栓(2)抓紧,然后送至需安装椎间融合器位置处进行安装,安装时定位凸起(108)与椎体上预制的凹槽相配合;
步骤五:通过器械将融合器本体(1)内的柱栓(2)向预制椎体孔洞推送,推送过程中柱栓(2)顶端的半球部分(201)以及上部主体插至预制的孔洞内,当栓柱(2)的底面推送至调节孔(103)中部平台平面以上时;再通过器械将柱栓(2)沿柱栓(2)主体的中轴线在调节孔(103)内顺时针或逆时针转动90°,柱栓(2)的柱形凸起(202)卡紧于调节孔(103)的平台上,柱栓(2)自锁于融合器本体(1)内;完成椎间融合器的安装工作。
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