CN105997310B - 骨小梁融合器 - Google Patents

骨小梁融合器 Download PDF

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CN105997310B
CN105997310B CN201610297282.5A CN201610297282A CN105997310B CN 105997310 B CN105997310 B CN 105997310B CN 201610297282 A CN201610297282 A CN 201610297282A CN 105997310 B CN105997310 B CN 105997310B
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bone trabecula
overcoat
bone
fusion device
trabecula
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CN105997310A (zh
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史春宝
肖鹏
解凤宝
申春林
徐祥祥
李德志
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Beijing Chunlizhengda Medical Instruments Co Ltd
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Beijing Chunlizhengda Medical Instruments Co Ltd
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Priority to PCT/CN2016/097825 priority patent/WO2017190460A1/zh
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    • A61F2/00Filters 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

本发明公开了一种骨小梁融合器,用于植入椎间盘中,包括:骨小梁外套(1),由钛合金粉末材料制成,内部设置有容置空间,骨小梁外套的侧壁面上设置有多个通孔,骨质通过通孔可长入骨小梁外套(1)内,以在椎间盘中稳定固定骨小梁融合器假体;内衬(2),由聚醚醚酮材料制成,固定在骨小梁外套(1)的容置空间内可与长入骨小梁外套通孔内的骨质相融合。本发明的骨小梁融合器,聚醚醚酮内衬可提供良好的融合性,骨小梁外套能使骨长入更多,本产品无需植骨,克服了材料的单一性让产品的性能大打折扣的问题,同时兼顾了较好的融合效果和骨长入效果,病人术后恢复快,且融合效果好。

Description

骨小梁融合器
技术领域
本发明涉及一种医用设备,尤其涉及一种植入椎间盘的骨小梁融合器。
背景技术
关于腰椎不稳症的治疗原则是,对于有明显神经压迫症状经保守治疗而症状无缓解者的情况,则列为手术治疗的适应症。手术疗法最初采用椎管减压椎间盘髓核摘除术,经后路切开椎间盘摘除突出的髓核及纤维环组织,以达到扩大椎管减压,解除对脊髓和神经根的压迫。但是,由于椎板的切除破坏了脊柱的结构,会造成脊柱产生新的不稳因素并且椎间隙压缩未得到恢复,导致术后具有较高的复发率。
后来,采用椎间盘摘除加脊椎融合术,在椎管减压髓核摘除的基础上进行各种方式的椎间植骨融合术,如棘突间植骨融合、横突间植骨融合、植骨加内固定器械融合术等。这种方式的融合式手术的目的在于增进椎骨间结构的强度,消除椎板切除后所导致的脊柱不稳,但并不能恢复椎间隙的高度,并且融合后椎间活动消失,从而导致相邻椎间盘的退变加速。从广泛的角度上单个椎间活动的活动减少也是一种“不稳”情况,因而临床上仍有不少患者出现术后植骨松动、折断、吸收及内固定器械的松动、断裂等现象。
传统融合器材料为纯聚醚醚酮材料(PEEK)或纯骨小梁材料,材料的单一性让产品的性能大打折扣,拥有了较好的融合效果却没有骨长入效果,二者不能共存,从而导致病人术后恢复慢,且融合效果相对不好。此外,如图1和图2所示,现在的传统融合器手术需要植入两枚融合器,手术复杂、困难,会导致创口大且多,出血较多,病人术后恢复慢,且融合效果相对不好。
发明内容
本发明的目的在于提供一种能够更好骨长入的骨小梁融合器。
为实现上述目的,本发明的一种骨小梁融合器的具体技术方案为:
一种骨小梁融合器,用于植入椎间盘中,包括:骨小梁外套,由钛合金粉末材料制成,内部设置有容置空间,骨小梁外套的侧壁面上设置有多个通孔,骨质通过通孔可长入骨小梁外套内,以在椎间盘中稳定固定骨小梁融合器假体;内衬,由聚醚醚酮材料制成,固定在骨小梁外套的容置空间内可与长入骨小梁外套通孔内的骨质相融合。
进一步,骨小梁外套的内壁面上设置有凸起,内衬的外壁面上设置有与凸起相匹配的凹陷,骨小梁外套的凸起嵌入在内衬的凹陷内以实现骨小梁外套与内衬固定连接在一起。
进一步,骨小梁外套内的凸起呈横梁状,内衬的凹陷与骨小梁外套的横梁凸起呈过盈配合。
进一步,骨小梁外套的一端部上设置有植入孔和植入槽,植入槽为骨小梁外套端面上的凹陷,植入孔位于植入槽内,通过与植入孔和植入槽相匹配的植入手术工具与骨小梁外套相连,将骨小梁融合器通过椎间隙后注入椎间盘中进行固定。
进一步,骨小梁外套一端部为凸起端,另一端部为平面端,植入孔和植入槽设置在平面端上。
进一步,植入孔为螺纹孔。
进一步,骨小梁外套的外形为光滑过渡的弧形,呈中间向两端逐渐收缩的形状。
进一步,骨小梁外套上外轮廓的弧形根据患者的脊柱椎体的横截面弧形进行设计。
进一步,骨小梁外套侧壁上的多个通孔可形成镂空的网状结构。
本发明的骨小梁融合器的优点在于:
1)本改进产品无需显影针术后显影,聚醚醚酮内衬可提供良好的融合性,骨小梁外套能使骨长入更多,本产品无需植骨,克服了材料的单一性让产品的性能大打折扣的问题,同时兼顾了较好的融合效果和骨长入效果,病人术后恢复快,且融合效果好;
2)使用骨小梁融合器能够使植入病人体内后的产品更安全更有效;
3)本产品外形结构更加符合人体解剖结构,能够使医生很简单的将植入物植入人体,在植入人体后的几个月,毛细血管及相关的组织会顺着外套的孔隙长入,使植入物与人体合为一体,达到不松动、不位移的效果;
4)本产品植入时方便快捷,使用设计的植入器械,与融合器尾部的螺纹连接上,通过椎间隙,植入进预先用其他器械处理好的椎间盘内,植入后骨长入量巨大,可使椎间盘稳定,从而达到更佳的骨性融合,相比其他融合器需要植骨,效果会好很多;
5)从医生角度来说手术操作方便快捷,手术入路从一个位置,到最后创口的处理,都从各方面大大缩短了手术的难度。
附图说明
图1为现有的融合器的结构示意图;
图2为现有的融合器的俯视图;
图3为本发明的骨小梁融合器的主视图;
图4为本发明的骨小梁融合器的侧视图。
具体实施方式
为了更好的了解本发明的目的、结构及功能,下面结合附图,对本发明的一种骨小梁融合器做进一步详细的描述。
如图3和图4所示,其示为本发明的一种骨小梁融合器,用于植入椎间盘,包括骨小梁外套1和内衬2,骨小梁外套1为钛合金粉末材料制成,通过金属3D打印机经过电子熔融术烧结成型,骨小梁外套1由左右侧壁面和上下端面围绕形成封闭空间,中间具有开口的容置空间,侧壁面上设置有多个通孔(图中未示),多个通孔在侧面上形成镂空的网状结构,骨质通过通孔长入骨小梁外套1内,有利于骨长入稳定骨小梁融合器假体;内衬2为聚醚醚酮(即为PEEK)材料制成可加强内衬2的强度,通过四轴加工中心制作而成,固定在骨小梁外套1的容置空间内可与长入骨小梁外套通孔内的骨质相融合,加强了骨融合的效果。本发明采用骨小梁外套1和聚醚醚酮的内衬2相组合植入椎间盘中,在临床手术上,镂空的骨小梁外套结构方便骨小梁融合器假体植入人体后,新骨能够长入骨小梁外套结构的缝隙中,使假体能够更稳固,同时,聚醚醚酮(PEEK)的内衬是为了加强骨小梁融合器的强度。
进一步,骨小梁外套1的内壁面上设置有凸起11,内衬2的外壁面上设置有与凸起相匹配的凹陷,骨小梁外套1的凸起嵌入在内衬2的凹陷内以实现骨小梁外套1与内衬2固定连接在一起。其中,本发明中的骨小梁外套内的凸起呈横梁状,内衬2的凹陷与骨小梁外套1的横梁凸起呈过盈配合,二者使用精密的机床加工能够充分地保证尺寸的公差,以使骨小梁外套1与内衬能够配合良好。
进一步,骨小梁外套1一端部呈凸起的圆弧状,另一端部呈平面状,平面端上设置有用于在手术中与植入手术工具相配合的植入孔12和植入槽13,植入槽12为骨小梁外套1端面上的凹陷,植入孔12位于植入槽14内,通过植入手术工具与植入孔12和植入槽13相配合连接,将骨小梁融合器通过椎间隙后注入椎间盘中进行固定,从医生角度来说手术操作更加方便快捷,手术入路从一个位置,到最后创口的处理,缩短了手术的难度。其中,本发明的植入孔12采用螺纹孔。
进一步,骨小梁外套1的外形为光滑过渡的弧形,呈逐渐向两端收缩的形状,中间部分比两端部分的内径较大,外轮廓的弧形根据患者的脊柱椎体的横截面弧形进行设计,更贴合患者椎体的弧度,具体外形根据患者的实际情况进行制作,符合人体解剖结构,能够使医生很简单的将植入物植入人体内。
本发明的骨小梁融合器,本改进产品无需显影针术后显影,聚醚醚酮内衬可提供良好的融合性,骨小梁外套能使骨长入更多,本产品无需植骨,克服了材料的单一性让产品的性能大打折扣的问题,同时兼顾了较好的融合效果和骨长入效果,病人术后恢复快,且融合效果好;使用骨小梁融合器能够使植入病人体内后的产品更安全更有效;本产品外形结构更加符合人体解剖结构,能够使医生很简单的将植入物植入人体,在植入人体后的几个月,毛细血管及相关的组织会顺着外套的孔隙长入,使植入物与人体合为一体,达到不松动、不位移的效果;本产品植入时方便快捷,使用设计的植入器械,与融合器尾部的螺纹连接上,通过椎间隙,植入进预先用其他器械处理好的椎间盘内,植入后骨长入量巨大,可使椎间盘稳定,从而达到更佳的骨性融合,相比其他融合器需要植骨,效果会好很多;从医生角度来说手术操作方便快捷,手术入路从一个位置,到最后创口的处理,都从各方面大大缩短了手术的难度。
以上借助具体实施例对本发明做了进一步描述,但是应该理解的是,这里具体的描述,不应理解为对本发明的实质和范围的限定,本领域内的普通技术人员在阅读本说明书后对上述实施例做出的各种修改,都属于本发明所保护的范围。

Claims (5)

1.一种骨小梁融合器,用于植入椎间盘中,其特征在于,包括:
骨小梁外套(1),由钛合金粉末材料制成,内部设置有容置空间,骨小梁外套的侧壁面上设置有多个通孔,骨质通过通孔可长入骨小梁外套(1)内,以在椎间盘中稳定固定骨小梁融合器假体;
内衬(2),由聚醚醚酮材料制成,固定在骨小梁外套(1)的容置空间内可与长入骨小梁外套通孔内的骨质相融合;
其中,骨小梁外套(1)的内壁面上设置有凸起(11),内衬(2)的外壁面上设置有与凸起相匹配的凹陷,骨小梁外套(1)的凸起嵌入在内衬(2)的凹陷内以实现骨小梁外套(1)与内衬(2)固定连接在一起;骨小梁外套(1)内的凸起(11)呈横梁状,内衬(2)的凹陷与骨小梁外套(1)的横梁凸起呈过盈配合;骨小梁外套(1)的外形为光滑过渡的弧形,呈中间向两端逐渐收缩的形状;骨小梁外套(1)上外轮廓的弧形根据患者的脊柱椎体的横截面弧形进行设计。
2.根据权利要求1所述的骨小梁融合器,其特征在于,骨小梁外套的一端部上设置有植入孔(12)和植入槽(13),植入槽(13)为骨小梁外套(1)端面上的凹陷,植入孔(12)位于植入槽(13)内,通过与植入孔(13)和植入槽(13)相匹配的植入手术工具与骨小梁外套(1)相连,将骨小梁融合器通过椎间隙后注入椎间盘中进行固定。
3.根据权利要求2所述的骨小梁融合器,其特征在于,骨小梁外套(1)一端部为凸起端,另一端部为平面端,植入孔(12)和植入槽(13)设置在平面端上。
4.根据权利要求2所述的骨小梁融合器,其特征在于,植入孔(12)为螺纹孔。
5.根据权利要求1所述的骨小梁融合器,其特征在于,骨小梁外套(1)侧壁上的多个通孔可形成镂空的网状结构。
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