CN112155806B - 一种椎板切除术后脊椎后路重建装置 - Google Patents
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Abstract
一种椎板切除术后脊椎后路重建装置，包括采用3D打印的呈半弧形的椎板主体，椎板主体分为两层，内层为致密层，外层四周为致密层，中心为孔隙率50‑80％，孔径为400‑800μm多孔结构层，所述3D打印的椎板主体原料采用按质量比为2：8‑5：5的聚己内酯和磷酸三钙混合物。本发明的人工椎板采用3D打印技术进行一体化设计，成型性强。在椎板外层中部打印多孔结构，可供松质骨填充后骨细胞的爬行和长入支架，有利于支架的骨整合和骨重建。椎板边缘和上下方连接处打印有椎板间拼接齿，用于人工椎板的横向与纵向组配。椎板外侧缘打印有固定槽，可卡扣到椎弓根钉尾完成固定。椎板打印采用的原材料为可完全降解的聚己内酯‑磷酸三钙混合物，体内完全降解的时间约为2‑3年。
Description
技术领域
本发明涉及一种医疗器械，具体涉及一种椎板切除术后脊椎后路重建装置。
背景技术
椎管狭窄是各种原因引起的椎管体积缩小，从而压迫硬膜囊、脊髓或神经根，从而导致疼痛，麻木，四肢无力等一系列神经症状的疾病。椎板切除减压术通过切除椎板，暴露椎板并清除椎管内病变，有效解决这一临床问题。而椎板切除后，脊柱后柱结构破坏，造成脊柱不稳，同时脊髓和硬膜囊因为失去椎板的保护而暴露在外。部分病人在缺损区域后方形成瘢痕组织，长入椎管缺损区域可造成再狭窄，并与硬膜，神经根发生黏连，产生术后并发症。因此，如何预防椎板切除术后的瘢痕黏连，并稳定脊柱后柱，一直是脊柱外科亟待解决的重要问题。
人工椎板是对椎板切除术后缺损区域进行修复的一种人工修复体，对继发性的瘢痕形成和纤维黏连有预防作用。人工椎板的作用与既往填充所用的透明质酸，自体脂肪和几丁糖等不同，其作为一种生物支架，在阻止纤维长入的同时重建了脊柱后柱的结构，具有良好的力学支撑。
目前所使用的人工椎板材料包括钛及钛合金，生物陶瓷等，生物活性不足，难以降解，长期存留在体内可能引起机体的排异反应。此外相关人工椎板设计结构复杂，构建困难，整体多为致密结构，阻碍了新生骨的长入与组织重建。而且目前应用的人工椎板多不可拼接，在固定时常需要配合螺钉固定，限制了相关产品的手术应用范围。
发明内容
本发明的目的在于提供一种能够解决椎板切除术后脊柱失稳和瘢痕黏连造成椎管再狭窄的问题，通过在切除部位填充3D打印的人工椎板，一方面产生遮挡作用，防止术后脊髓后方组织长入；另一方面椎板降解与骨形成同步发生，最终完成椎板的骨性重塑。
为达到上述目的，本发明采用的技术方案是：包括采用3D打印的呈半弧形的椎板主体，椎板主体分为两层，内层为致密层，外层四周为致密层，中心为孔隙率50-80％，孔径为400-800μm多孔结构层，所述3D打印的椎板原料采用按质量比为2：8-5：5的聚己内酯和磷酸三钙混合物。
所述椎板主体为颈椎椎板，其长度AB为10-15mm，横向跨度CD为10-15mm，椎板厚度EF为3-5mm，弓高为10-12mm，内层致密层厚度为2mm，外层厚度为1-3mm。
所述椎板主体为胸椎或腰椎椎板，其长度为15-30mm，横向跨度为10-15mm，椎板厚度为6-8mm，弓高为10-12mm，内层致密层厚度为4mm，外层厚度为2-4mm。
所述的椎板主体的一侧边缘设置有可将两块半椎板左右拼接的半椎板间拼接齿。
所述的椎板主体的上下方设置有可用于多块椎板上下拼接的上下椎板间拼接齿。
所述的半椎板间拼接齿与上下椎板间拼接齿侧面等腰梯形的上边长为3mm，下边长为2mm，高为2mm。拼接齿的宽度与椎板宽度相同。
所述的椎板主体外侧缘设置有能够根据椎弓根螺钉尺寸裁剪，与钉尾锁合固定，从而直接将椎板主体固定于钉棒系统上的连续直径为3-5mm的半弧形固定卡槽。
所述的椎板主体上还开设有用于全椎板切除术后两块椎板左右拼接，相邻椎板主本可骑跨的棘突容纳槽。
针对现有技术中人工椎板结构复杂，构建困难的问题，本发明的人工椎板采用3D打印技术进行一体化设计，成型性强。针对现有技术中椎板为致密结构，阻碍了骨长入与组织连接的问题，本发明在椎板外层中部打印多孔式结构，可供松质骨填充后骨细胞的爬行和长入支架，有利于支架的骨整合和骨重建。针对现有技术中人工椎板材料多为不可降解的金属或陶瓷材料的问题，本发明采用的原材料为可完全降解的聚己内酯-磷酸三钙混合物，椎板体内完全降解的时间约为2-3年。
进一步的，针对现有技术中人工椎板不可拼接，造成人工椎板手术应用范围受限的问题，本发明设置有椎板间拼接齿，可用于人工椎板的横向和纵向组配，可满足半椎板切除，全椎板切除，以及多个节段的切除后重建。
进一步的，针对现有技术中人工椎板常需配合螺钉固定的问题，本发明在椎板外侧边缘设置有连续固定的半弧形固定可直接卡扣到椎弓根钉尾部，整个椎板不需要多余的固定。
附图说明
图1是本发明的整体结构示意图。
具体实施方式
下面结合附图对本发明作进一步详细说明。
参见图1，本发明为一种3D打印组配式可降解人工椎板，采用的原料是聚己内酯-磷酸三钙混合物(w/w 2:8-5:5)，椎板降解时间大约为24-36个月。采用的打印技术是熔融挤出成型(FDM)，整个人工椎板为一体化设计。人工椎板主体1呈半弧形，根据不同位置椎板参数各有不同。颈椎椎板长度(AB)为10-15mm，横向跨度(CD)为10-15mm，椎板厚度(EF)为3-5mm，弓高为10-12mm；胸椎和腰椎椎板长度为15-30mm，横向跨度为10-15mm，椎板厚度为6-8mm，弓高为10-12mm。椎板主体1分内外两层，内层为致密结构，外层中心为多孔结构(孔隙率在50-80％，孔径大小为400-800μm)，外层四周仍为致密结构(考虑到多孔结构不利于连接和固定问题)。在椎板主体1的一侧边缘设置有可将两块半椎板左右拼接的半椎板间拼接齿3；在椎板主体1的上下方设置有可用于多块椎板上下拼接的上下椎板间拼接齿4，其中半椎板间拼接齿3与上下椎板间拼接齿4侧面等腰梯形的上边长为3mm，下边长为2mm，高为2mm，拼接齿与椎板同宽。在椎板主体1外侧缘设置有能够根据椎弓根螺钉尺寸裁剪，与钉尾锁合固定，从而直接将椎板主体固定于钉棒系统上的连续直径为3-5mm的半弧形固定卡槽6。在椎板主体1上还开设有用于全椎板切除术后两块椎板左右拼接，可骑跨相邻椎体棘突的棘突容纳槽2。
本发明用于填充椎板切除术后的椎板缺损区域，早期能够起到稳定脊柱和防止周围组织肿胀压迫椎管的作用，后期该人工椎板可被骨性结构所替代，达到脊柱后柱的融合稳定的效果。发明外层的均匀多孔连通结构有利于间充质干细胞和成骨细胞的早期迁移与成骨分化，最终可形成骨性结构。发明中单个椎板可用于半椎板切除术后重建，两侧椎板间拼接齿可将两块半椎板拼接为一块完整椎板，可用于全椎板切除术后重建，上下方椎板间拼接齿可将椎板进行纵向拼接，用于多个脊柱节段的椎板切除术后重建。人工椎板外侧边缘设计有连续排列的半弧形卡槽，用于与椎弓根尾部锁合固定。
本发明1为椎板主体，整个椎板为3D打印完成，呈半弧形。该人工椎板分颈椎椎板和胸腰椎椎板两种类型；厚度分别为3-5mm(颈椎)与6-8mm(胸腰椎)。椎板主体分为两层，内层为致密层，外层四周为致密层，中心为多孔层。2为棘突容纳槽，主要用于全椎板切除术后(两块椎板左右拼接)，人工椎板可骑跨于棘突。3为半椎板间拼接齿，可将两块半椎板左右拼接，从而完成全椎板切除术后重建。4为上下椎板间拼接齿，可用于多块椎板上下拼接，完成多个节段的椎板切除术后重建。5为多孔结构，其位于椎板外层中部，厚度为1-3mm(颈椎)或2-4mm(胸腰椎)，其孔隙率为50-80％，孔径大小为400-800μm(根据文献报道有利于骨长入)。6为人工椎板边缘固定凹槽，为连续半弧形凹槽，可与椎弓根尾部锁合固定，完成人工椎板即刻固定。
Claims (4)
1.一种椎板切除术后脊椎后路重建装置，其特征在于：包括采用3D打印的呈半弧形的椎板主体(1)，椎板主体(1)分为两层，内层为致密层，外层四周为致密层，中心为孔隙率50-80％，孔径为400-800μm多孔结构层(5)，所述3D打印的椎板主体原料采用按质量比为2：8-5：5的聚己内酯和磷酸三钙混合物；
所述的椎板主体(1)的一侧边缘设置有可将两块半椎板左右拼接的半椎板间拼接齿(3)；
所述的椎板主体(1)的上下方设置有可用于多块椎板上下拼接的上下椎板间拼接齿(4)；
所述的椎板主体(1)边缘设置有能够根据椎弓根螺钉尺寸裁剪，与钉尾锁合固定，从而直接将椎板主体固定于钉棒系统上的连续直径为3-5mm的半弧形固定卡槽(6)；
所述的椎板主体(1)上还开设有用于全椎板切除术后两块椎板左右拼接后，可骑跨相邻椎体棘突的棘突容纳槽(2)。
2.根据权利要求1所述的椎板切除术后脊椎后路重建装置，其特征在于：所述椎板主体(1)为颈椎椎板，其长度AB为10-15mm，横向跨度CD为10-15mm，椎板厚度EF为3-5mm，弓高为10-12mm，内层致密层厚度为2mm，外层厚度为1-3mm。
3.根据权利要求1所述的椎板切除术后脊椎后路重建装置，其特征在于：所述椎板主体(1)为胸椎或腰椎椎板，其长度为15-30mm，横向跨度为10-15mm，椎板厚度为6-8mm，弓高为10-12mm，内层致密层厚度为4mm，外层厚度为2-4mm。
4.根据权利要求1所述的椎板切除术后脊椎后路重建装置，其特征在于：所述的半椎板间拼接齿(3)与上下椎板间拼接齿(4)侧面等腰梯形的上边长为3mm，下边长为2mm，高为2mm，拼接齿的宽度与椎板相同。
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