CN106063720A - 一种骨科医疗器械胫骨接骨板 - Google Patents

一种骨科医疗器械胫骨接骨板 Download PDF

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CN106063720A
CN106063720A CN201610441368.0A CN201610441368A CN106063720A CN 106063720 A CN106063720 A CN 106063720A CN 201610441368 A CN201610441368 A CN 201610441368A CN 106063720 A CN106063720 A CN 106063720A
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Abstract

一种骨科医疗器械胫骨接骨板，包括接骨板本体，接骨板本体呈“T”型，所述接骨板本体具有一与胫骨表面接触的贴附面1，和与贴附面1相对的接骨板本体安装面（2），所述接骨板开有安装通孔（3），贴附面1表面为氧化锆系陶瓷材料层，安装面（2）表面为碳化钛系陶瓷材料层，安装通孔（3）内表面为氧化铬系陶瓷材料层，钛合金材料的选用及接骨板呈“T”使接骨板具备了必要的高强度；2）对该成分的钛合金进行酸洗及钝化的表面处理工序，避免出现任何表面黑点等问题，使获得表面整洁。

Description

一种骨科医疗器械胫骨接骨板
技术领域
本发明涉一种骨科医疗器械胫骨接骨板，属于医疗器械技术领域。
背景技术
胫骨近端骨折是一种常见的骨折，其发生率约为全身骨折的2.5％，多见于青壮年高能量创伤及老年人骨折疏松性骨折，治疗的目的是最大限度的恢复肩关节的功能，保守治疗愈合多不理想，而以往的内固定技术又很难达到坚强的稳定使肩关节能进行早期安全的功能锻炼，尤其是肱骨近端的粉碎性骨折，其治疗存在诸多选择和争议。
发明内容
本发明就是针对上述问题而提出的一种工艺简单、成本低、生物相容性良好的骨科医疗器械胫骨接骨板。
一种骨科医疗器械胫骨接骨板，包括接骨板本体，接骨板本体呈“T”型，所述接骨板本体具有一与胫骨表面接触的贴附面（1），和与贴附面（1）相对的接骨板本体安装面（2），所述接骨板开有安装通孔（3），贴附面（1）表面为氧化锆系陶瓷材料层，安装面（2）表面为碳化钛系陶瓷材料层，安装通孔（3）内表面为氧化铬系陶瓷材料层，
接骨板本体制备方法：包括以下步骤：接骨板本体化学组成为（重量）：Zn：14.7﹪、Al：6.8﹪、Fe：4.9﹪，Si：1.6﹪、Mg 1.7﹪、Ni 0.78﹪、Cu：0.59﹪、Cd：0.27﹪、Zr：0.078﹪、Ce：0.038﹪、Mn ：0.057﹪，V：0.066﹪，B：0.087﹪，余量为Ti以及不可避免的杂质；按照比例配制合金，合金材料熔炼、浇注：熔炼温度：1817℃，浇注温度为1758℃；脱模后，得到的接骨板本体进行热处理：首先将接骨板本体进行加热，升温至950℃，升温速率300℃/小时，保温6小时，后降温至650℃，降温速率100℃/小时，保温7小时，后升温至800℃，升温速率100℃/小时，保温4小时，后再次降温至450℃，降温速率50℃/小时，保温9小时，后再次降温至250℃，降温速率40℃/小时，保温6小时，后空冷至室温，
之后对接骨板本体表面进行酸洗和钝化处理，其中：
酸洗液组成为（重量）：采取98%浓H2SO4 48份，36.5%的HCL 18份，丙酸2.5份，乙二胺4份、烷基咪唑啉季铵盐14份；水18份；
钝化液组成为（重量）：聚酰亚胺14份，2-(3，4-环氧环己基)乙基三甲氧基硅烷9份，N-(2-氨基乙基)-3-氨基丙基甲基二甲氧基硅烷2.9份，氟硼酸钠12份，硫酸3份，二烷基二硫代磷酸氧钼6.8份，水34份；
对接骨板本体贴附面（1）表面进行涂覆氧化锆系陶瓷材料；通过涂覆在贴附面（1）表面形成氧化锆系陶瓷材料层，氧化锆系陶瓷材料层厚度0.4mm，氧化锆系陶瓷材料层成分包括（重量）：氧化锆 59份，硼化钛28份，碳化钛 27份，氧化硅1.8份，将涂覆后的接骨板本体进行加热，升温至750℃，升温速率250℃/小时，保温4小时，后降温至550℃，降温速率100℃/小时，保温3小时，后再次降温至250℃，降温速率75℃/小时，保温7小时，后空冷至室温，
之后对接骨板本体安装面（2）表面进行涂覆碳化钛系陶瓷材料；通过涂覆在安装面（2）表面形成碳化钛系陶瓷材料层，碳化钛系陶瓷材料层厚度0.5mm，碳化钛系陶瓷材料层成分包括（重量）：碳化钛 90份，氮化钛18份，碳化铬 10份，氧化钛7份，将涂覆后的接骨板本体进行加热，升温至600℃，升温速率200℃/小时，保温3小时，后降温至400℃，降温速率100℃/小时，保温7小时，后再次降温至100℃，降温速率50℃/小时，保温12小时，后空冷至室温，
之后对接骨板本体安装通孔（3）内表面进行涂覆氧化铬系陶瓷材料，氧化铬系陶瓷材料层厚度0.3mm，氧化铬系陶瓷材料层成分包括（重量）：氧化铬70份，碳化铬38份，氮化钛20份，硼化钛9份，得到最终接骨板。
上述发明内容相对于现有技术的有益效果在于：1）钛合金材料的选用及接骨板呈“T”使接骨板具备了必要的高强度；2）对该成分的钛合金进行酸洗及钝化的表面处理工序，避免出现任何表面黑点等问题，使获得表面整洁；3）通过在根据接骨板接触人体细胞的种类不同在贴附面和安装面表面涂覆氧化锆系陶瓷材料层和碳化钛系陶瓷材料，提高材料的生物相容性。4）对安装通孔表面进行涂覆提高其耐磨性使得固定紧凑。
附图说明
图1为接骨板正视图
图2为接骨板侧视图。
具体实施方式
实施例1
一种骨科医疗器械胫骨接骨板，包括接骨板本体，接骨板本体呈“T”型，所述接骨板本体具有一与胫骨表面接触的贴附面（1），和与贴附面（1）相对的接骨板本体安装面（2），所述接骨板开有安装通孔（3），贴附面（1）表面为氧化锆系陶瓷材料层，安装面（2）表面为碳化钛系陶瓷材料层，安装通孔（3）内表面为氧化铬系陶瓷材料层，
接骨板本体制备方法：包括以下步骤：接骨板本体化学组成为（重量）：Zn：14.7﹪、Al：6.8﹪、Fe：4.9﹪，Si：1.6﹪、Mg 1.7﹪、Ni 0.78﹪、Cu：0.59﹪、Cd：0.27﹪、Zr：0.078﹪、Ce：0.038﹪、Mn ：0.057﹪，V：0.066﹪，B：0.087﹪，余量为Ti以及不可避免的杂质；按照比例配制合金，合金材料熔炼、浇注：熔炼温度：1817℃，浇注温度为1758℃；脱模后，得到的接骨板本体进行热处理：首先将接骨板本体进行加热，升温至950℃，升温速率300℃/小时，保温6小时，后降温至650℃，降温速率100℃/小时，保温7小时，后升温至800℃，升温速率100℃/小时，保温4小时，后再次降温至450℃，降温速率50℃/小时，保温9小时，后再次降温至250℃，降温速率40℃/小时，保温6小时，后空冷至室温，
之后对接骨板本体表面进行酸洗和钝化处理，其中：
酸洗液组成为（重量）：采取98%浓H2SO4 48份，36.5%的HCL 18份，丙酸2.5份，乙二胺4份、烷基咪唑啉季铵盐14份；水18份；
钝化液组成为（重量）：聚酰亚胺14份，2-(3，4-环氧环己基)乙基三甲氧基硅烷9份，N-(2-氨基乙基)-3-氨基丙基甲基二甲氧基硅烷2.9份，氟硼酸钠12份，硫酸3份，二烷基二硫代磷酸氧钼6.8份，水34份；
对接骨板本体贴附面（1）表面进行涂覆氧化锆系陶瓷材料；通过涂覆在贴附面（1）表面形成氧化锆系陶瓷材料层，氧化锆系陶瓷材料层厚度0.4mm，氧化锆系陶瓷材料层成分包括（重量）：氧化锆 59份，硼化钛28份，碳化钛 27份，氧化硅1.8份，将涂覆后的接骨板本体进行加热，升温至750℃，升温速率250℃/小时，保温4小时，后降温至550℃，降温速率100℃/小时，保温3小时，后再次降温至250℃，降温速率75℃/小时，保温7小时，后空冷至室温，
之后对接骨板本体安装面（2）表面进行涂覆碳化钛系陶瓷材料；通过涂覆在安装面（2）表面形成碳化钛系陶瓷材料层，碳化钛系陶瓷材料层厚度0.5mm，碳化钛系陶瓷材料层成分包括（重量）：碳化钛90份，氮化钛18份，碳化铬 10份，氧化钛7份，将涂覆后的接骨板本体进行加热，升温至600℃，升温速率200℃/小时，保温3小时，后降温至400℃，降温速率100℃/小时，保温7小时，后再次降温至100℃，降温速率50℃/小时，保温12小时，后空冷至室温，
之后对接骨板本体安装通孔（3）内表面进行涂覆氧化铬系陶瓷材料，氧化铬系陶瓷材料层厚度0.3mm，氧化铬系陶瓷材料层成分包括（重量）：氧化铬70份，碳化铬38份，氮化钛20份，硼化钛9份，得到最终接骨板。

Claims (1)

1.一种骨科医疗器械胫骨接骨板，包括接骨板本体，接骨板本体呈“T”型，所述接骨板本体具有一与胫骨表面接触的贴附面1，和与贴附面1相对的接骨板本体安装面（2），所述接骨板开有安装通孔（3），贴附面1表面为氧化锆系陶瓷材料层，安装面（2）表面为碳化钛系陶瓷材料层，安装通孔（3）内表面为氧化铬系陶瓷材料层，
接骨板本体制备方法：包括以下步骤：接骨板本体化学组成为（重量）：Zn：14.7﹪、Al：6.8﹪、Fe：4.9﹪，Si：1.6﹪、Mg 1.7﹪、Ni 0.78﹪、Cu：0.59﹪、Cd：0.27﹪、Zr：0.078﹪、Ce：0.038﹪、Mn ：0.057﹪，V：0.066﹪，B：0.087﹪，余量为Ti以及不可避免的杂质；按照比例配制合金，合金材料熔炼、浇注：熔炼温度：1817℃，浇注温度为1758℃；脱模后，得到的接骨板本体进行热处理：首先将接骨板本体进行加热，升温至950℃，升温速率300℃/小时，保温6小时，后降温至650℃，降温速率100℃/小时，保温7小时，后升温至800℃，升温速率100℃/小时，保温4小时，后再次降温至450℃，降温速率50℃/小时，保温9小时，后再次降温至250℃，降温速率40℃/小时，保温6小时，后空冷至室温，
之后对接骨板本体表面进行酸洗和钝化处理，其中：
酸洗液组成为（重量）：采取98%浓H2SO4 48份，36.5%的HCL 18份，丙酸2.5份，乙二胺4份、烷基咪唑啉季铵盐14份；水18份；
钝化液组成为（重量）：聚酰亚胺14份，2-(3，4-环氧环己基)乙基三甲氧基硅烷9份，N-(2-氨基乙基)-3-氨基丙基甲基二甲氧基硅烷2.9份，氟硼酸钠12份，硫酸3份，二烷基二硫代磷酸氧钼6.8份，水34份；
对接骨板本体贴附面（1）表面进行涂覆氧化锆系陶瓷材料；通过涂覆在贴附面（1）表面形成氧化锆系陶瓷材料层，氧化锆系陶瓷材料层厚度0.4mm，氧化锆系陶瓷材料层成分包括（重量）：氧化锆 59份，硼化钛28份，碳化钛 27份，氧化硅1.8份，将涂覆后的接骨板本体进行加热，升温至750℃，升温速率250℃/小时，保温4小时，后降温至550℃，降温速率100℃/小时，保温3小时，后再次降温至250℃，降温速率75℃/小时，保温7小时，后空冷至室温，
之后对接骨板本体安装面（2）表面进行涂覆碳化钛系陶瓷材料；通过涂覆在安装面（2）表面形成碳化钛系陶瓷材料层，碳化钛系陶瓷材料层厚度0.5mm，碳化钛系陶瓷材料层成分包括（重量）：碳化钛 90份，氮化钛18份，碳化铬 10份，氧化钛7份，将涂覆后的接骨板本体进行加热，升温至600℃，升温速率200℃/小时，保温3小时，后降温至400℃，降温速率100℃/小时，保温7小时，后再次降温至100℃，降温速率50℃/小时，保温12小时，后空冷至室温，
之后对接骨板本体安装通孔（3）内表面进行涂覆氧化铬系陶瓷材料，氧化铬系陶瓷材料层厚度0.3mm，氧化铬系陶瓷材料层成分包括（重量）：氧化铬70份，碳化铬38份，氮化钛20份，硼化钛9份，得到最终接骨板。
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