CN1073395C - 异种皮质骨内固定器制作方法及按该方法制得的椎体固定器 - Google Patents
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Abstract
异种皮质骨内固定器的制作方法及按该方法制得的椎体固定器涉及骨外科处理中的接骨器具。用健康、新鲜之牛。猪等动物长骨经特殊处理，将皮质骨机械加工成生物钉、棒、板及椎体固定器，湿式包装后灭菌备用。本发明的内固定器有一定的机械强度，无毒、无致癌性与过敏反应，与人体组织相容性好，可缓慢吸收，取材容易，加工储存简便，是一种理想的骨折内固定器。
Description
异种皮质骨内固定器制作方法及按该方法制得的椎体固定器涉及骨外科处理中的接骨器具。
现在骨科手术的内固定物材料，除很少部分为非金属材料外(如陶瓷及高分子材料)，极大部分为金属材料(如铬镍不锈钢、钴合金、钛合金等)，它们虽有足够的力学强度和抗疲劳性能，但其存在的问题是：一般均需二次手术取出；有植入物蚀损、金属过敏反应等合并症；尤其在生物力学上，由于金属材料与人体骨骼材料的弹性模量差距太大，应力遮挡作用太强，易发生金属材料下方的骨皮质“应力性骨质疏松”而导致再骨折。
国内有少量利用自体或同种异体骨作为内固定物治疗骨折的报道，如自体腓骨栓用于股骨颈骨折的固定，但这是以损失病人自体部分健康骨骼为代价的一种方法；取意外死亡者的异体长管状骨对骨折不愈合的病人实施内固定治疗，虽是一种性能良好的生物材料，但取材困难。
国外有一种商品化的Kiel骨，是异种骨，且在修复骨缺损，实行关节融合及充填骨死腔方面取得满意效果。如用Kiel骨治疗牙冠缺损，术后9个月骨髂愈合良好；治疗骨肿瘤切除术后骨缺损，大部分患者移植骨10年内能与受体骨融为一体。这些只解决了植骨中的“充填缺损”与“促进愈合”二个目的，而对于植骨的第三个目的一用异种骨作为固定物提供支撑则尚未见报道。
本发明旨在用异种皮质骨作为骨折内固定物，以提供支撑解决骨传导作用。
下面结合附图阐述本发明的技术方案。
图1螺钉形异种皮质骨内固定器；
图2圆棒形异种皮质骨内固定器；
图3三棱棒形异种皮质骨内固定器；
图4接骨板形异种皮质骨内固定器；
图5异种皮质骨椎体固定器结构示意图。
实现本发明目的的技术方案如下：经检疫批准宰杀的牛、猪、羊、马等动物在宰杀6小时内取其长骨，剥除骨膜，除去骨内蛋白质、脂肪等有机成份，初加工成长条、平板、半圆块状毛胚，清洗后置于75％酒精内，一周内机械加工成不同规格的螺钉(图1)、圆棒(图2)、三棱棒(图3)、接骨板(图4)与椎体固定器(图5)，洁净后置于盛满保养液的玻璃器皿中密封或用浸透了保养液的棉纸包裹后装入塑料袋内密封，以剂量为15KGY的60Cor射线照射或环氧乙烷气薰灭菌后，常温下储存备用，异种皮质骨内固定材料的抗压极限荷载为150.92～200.9MPa，抗折极限荷载20.58～23.52MPa，抗拉极限荷载114.76～168.76MPa，抗扭极限荷载98.0～129.4MPa。椎体固定器是由两半圆块状1异种皮质骨组成的圆柱体，圆柱体外周为螺纹状，中部为圆柱孔状轴心2，半圆块上一纵向方槽3，两半圆块相嵌或由生物固定梢4固定，侧面设通孔5，一端有气孔6。
钉、棒、板类异种皮质骨内固定器根据不同部位和不同类型骨折固定的需要加工成不同规格。如生物钉的规格直径在4.5～6.5mm，长度为20～80mm；圆棒直径在2～4.5mm，长度为25～60mm；三棱棒的棱宽6～10mm，棒长40～100mm；接骨板的厚度为3mm，宽度15～20mm，长度70～90mm。
皮质骨固定器使用前应注意将整个包装在消毒液(络合碘或碘酒)中浸泡2小时或福尔马林薰箱中48小时后才拆封使用，尤其要注意包装是否破损，如有破损痕迹，则需重新灭菌。
使用异种皮质骨固定器时，一定要选择合适的规格。这是因为：(1)生物钉(棒)要恰如其分的拧入不容易，(2)一旦拧入要拨出而不损坏也难。另外，手术器械一定要匹配。为此皮质骨钉制作了与之相应的丝锥。在锯钉(棒)时，用高频率齿科锐锯为宜，也可用激光锯钉(棒)。手术使用皮质骨钉时，可将钉在青霉素粉剂(PNC皮试阴性者)内滚动一遍，除了防止感染外，也增加了皮质骨钉的润滑性(若PNC皮试阳性，改用无菌石腊油)。
从1995年起，申请人使用异种骨制成的螺钉、园棒、三棱棒、接骨板治疗锁骨远端骨折、肱骨大结节骨折、肱骨内外髁骨折、尺骨鹰咀骨折、前臂骨单骨折、桡骨远端骨折、掌骨骨折、髋臼骨折、胫骨平台骨折、髌骨骨折、内外踝骨折、跟骨骨折、三关节融合、椎体切除后植骨块固定等共39例。随访3月～3年，近期效果尚好。除2例切口乙级愈合，经换药7～14天治愈外，其余切口均甲级愈合。植入的钉、棒、板中，有8例显示钉(棒)影消失，有31例显示钉(棒)影变淡、边缘模糊，呈虫蚀样改变(见附表)。
附表：
| 部位 | 例数 | 骨愈合时间 | 生物钉吸收例数 | 生物钉吸收时间 | 并发症 | ||
| 切口愈合 | 钉棒折断 | 功能受限 | |||||
| 锁骨远端 | 2 | 2-2.5月 | 2 | 6-8月 | 均甲 | ||
| 肱骨外科颈 | 2 | 2.5月 | 均甲 | ||||
| 肱骨髁 | 1 | 2月 | 1 | 8月 | 甲 | ||
| 尺骨鹰咀 | 4 | 1.5-2月 | 均甲 | 1(无移位) | |||
| 尺挠骨干 | 1 | 2.2月 | 甲 | ||||
| 掌骨 | 2 | 1.2-1.5月 | 1 | 6月 | 均甲 | ||
| 髋臼 | 3 | 1-1.5月 | 1 | 8月 | 均甲 | ||
| 股骨颈 | 3 | 2-2.5月 | 均甲 | ||||
| 股骨髁 | 2 | 1月 | 1 | 6月 | 均甲 | ||
| 髌骨 | 2 | 1.5-2月 | 均甲 | 2 | |||
| 胫骨平台 | 3 | 2-2.5月 | 2-甲1-乙 | ||||
| 内外髁 | 8 | 2-2.5月 | 2 | 8-12月 | 7-甲1-乙 | ||
| 跟骨 | 3 | 1.5-2月 | 均甲 | ||||
| 跖骨 | 1 | 1.2月 | 甲 | ||||
| 椎体植骨固定 | 1 | 1.5月 | 甲 | ||||
| 三关节融合 | 1 | 2月 | 甲 | ||||
| 共计 | 39 | 8 | 37-甲2-乙 | ||||
本发明提供的异种皮质骨固定器具有以下特点：
1、有足够的力学强度和抗疲劳性能。经湖南大学和长沙铁道学院土建材料实验室测试，其抗压极限荷载平均178.03，抗折极限荷载平均22.21，抗拉极限荷载平均139.95，抗扭极限荷载平均117.77，与Reilg及陈林堂等测定的成人股骨皮质骨极限强度基本相同。采用15KGY60Cor射线或环氧乙烷灭菌，对致病微生物有甚好杀灭作用，又不降低材料的抗折强度。
2、与人体组织的相容性好。本材料经湖南医科大学附属二医院创伤骨科实验室对28只新西兰兔的动物实验表明，植入牛骨棒固定骨折后1-6周，观察到的局部组织学变化：未见淋巴细胞，少量炎性细胞随植入时间的延长而减少，牛骨与兔骨的间隙逐渐变窄，说明异种皮质骨的生物相容性良好。临床应用也证明了异种皮质骨与人体骨组织的相容性尚好。
3、无毒、无致癌性与过敏反应。用浸提液的体外细胞培养试验进行毒性检测以及临床应用结果证明了这点。
4、可缓慢吸收。异种皮质骨骨质密集，空隙小，与受区的组织液交流少，营养物质不容易通过皮质骨，骨的爬行替代过程较长。
异种皮质骨的缓慢吸收过程正好符合骨折愈合过程中对固定物的强度要求。在骨折的早期，需要坚强的固定，以保证骨折在关节活动中愈合，又具有一定弹性，在骨折的中、后期，则需要固定物的强度逐渐降低，以便压应力通过骨折部，利于骨痂的生长和骨的模造，是其他内固定材料所不及的。
5、无免疫排斥反应。皮质骨的免疫排斥反应本来就较松质骨轻，本发明的异种皮质骨材料以特殊方法处理，去除了骨内的蛋白质和脂肪等有机成分，只留下无机成分，因此更无免疫排斥反应，当然亦无骨诱导作用，只有骨传导作用。
本发明适用范围为：关节内和关节附近骨折的固定；股骨颈骨折的固定；前臂骨横形、轻度粉碎骨折，肱骨、胫骨长斜形或螺旋形骨折的固定；踝关节的关节融合；肌骨瓣的固定；椎体切除后植骨块的固定与椎体的固定。使用本发明异种皮质骨内固定器除了掌握内固定手术的一般禁忌症外，应避免使用于骨骺未发育完成的少年儿童、有骨质疏松症的老人以及股骨干和股骨粗隆间骨折的固定。
除此以外，异种皮质骨内固定器材料来源广泛，加工容易，易保存与运输。
Claims (2)
1、一种异种皮质骨内固定器的制作方法，其特征在于经检疫批准宰杀的牛、猪、羊、马等动物，在宰杀6小时内取其长骨，剥除骨膜，除去骨内蛋白质、脂肪等有机成份，初加工成长条、平板、半圆块状毛胚，清洗后置入75％酒精内，一周内机械加工成不同规格的螺钉、圆棒、三棱棒、接骨板与椎体固定器，洁净后置入盛满保养液的玻璃器皿中密封或用浸透了保养液的棉纸包裹后装入塑料袋内密封，以剂量为15KGY的60Cor射线照射或环氧乙烷气薰灭菌后，常温下储存备用，异种皮质骨内固定材料的抗压极限荷载为150.92～200.9MPa，抗折极限荷载20.58～23.52MPa，抗拉极限荷载114.76～168.76MPa，抗扭极限荷载98.0～129.4MPa。
2、一种按权利要求1所述方法制得的异种皮质骨椎体固定器，其特征在于内固定器是由两半圆块状(1)异种皮质骨组成的圆柱体，圆柱体外周为螺纹状，中部为圆柱孔状轴心(2)，半圆块上有一纵向方槽(3)，两半圆块相嵌或由生物固定梢(4)固定，侧面设通孔(5)，一端有气孔(6)。
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| CN 98112370 CN1073395C (zh) | 1998-03-09 | 1998-03-09 | 异种皮质骨内固定器制作方法及按该方法制得的椎体固定器 |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 98112370 CN1073395C (zh) | 1998-03-09 | 1998-03-09 | 异种皮质骨内固定器制作方法及按该方法制得的椎体固定器 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1228292A CN1228292A (zh) | 1999-09-15 |
| CN1073395C true CN1073395C (zh) | 2001-10-24 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN 98112370 Expired - Fee Related CN1073395C (zh) | 1998-03-09 | 1998-03-09 | 异种皮质骨内固定器制作方法及按该方法制得的椎体固定器 |
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| Country | Link |
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| CN (1) | CN1073395C (zh) |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1839773B (zh) * | 2005-04-01 | 2011-05-04 | 祝天经 | 一种去抗原异种骨的制备方法 |
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| Publication number | Publication date |
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| CN1228292A (zh) | 1999-09-15 |
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