CN106137288B - 一种镁基金属带线锚钉及其植入装置 - Google Patents
一种镁基金属带线锚钉及其植入装置 Download PDFInfo
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Abstract
本发明公开了一种镁基金属带线锚钉及其植入装置，涉及医疗器械领域，本发明所述的镁基金属带线锚钉，包括锚钉本体、植入棒和牵引线，所述锚钉本体为燕尾形，所述锚钉本体上设有栓孔，所述植入棒为管状，所述牵引线被配置为穿过所述植入棒和所述栓孔连接，所述植入棒与所述锚钉本体固定连接。本发明还提供了一种植入装置，所述植入装置为中空的套筒，近端具有握持部，远端具有梯形斜面，所述中空的部位被配置为插入所述带线锚钉和植入棒；当抽拉所述牵引线时，所述梯形斜面被配置为撑开所述锚钉本体的燕尾形的燕尾。本发明的镁基金属带线锚钉抗拔出力强，可在生物体内降解吸收且降解速率可控，具有良好的生物相容性，良好的骨整合能力。
Description
技术领域
本发明涉及医疗器械领域，尤其涉及一种镁基金属带线锚钉及其植入装置。
背景技术
近年来，人们对于运动损伤的越来越重视。肌腱近附着点撕脱或者撕脱性骨折是运动损伤中最为常见的损伤之一。常见的有肩袖损伤、膝关节交叉韧带损伤、锤状指等。该损伤严重影响着受累关节的功能，造成不可逆的后果。带线锚钉是治疗肌腱近附着点损伤的主要手段之一。这是一种小型的医疗植入物，能够将损伤的软组织和骨重新连接。其机制是通过缝针将线穿过软组织，并打结将软组织固定于锚钉上，即骨表面。
可降解材料作为一种医疗植入物成为了骨科基础研究和临床研究的热点。目前所广泛认可的可降解材料主要分为两种：可降解聚合物和可降解金属。目前可降解的带线锚钉材料均为可降解聚合物材料。可降解聚合物在生物体内可以降解，降解产物无毒可吸收，生物相容性好。在这些材料中，最主要的就是聚乙交酯(PGA)和聚丙交酯(PLA)。它们都是生物相容性材料，引起的组织反应很小。但是这种聚乳酸带线锚钉具有一定的局限性。首先，聚乳酸带线锚钉的力学强度不够，只能用于骨质较好的患者。其次，聚乳酸带线锚钉如果用力不当容易发生断裂，导致锚钉失效。另外，目前的各种聚乳酸带线锚钉只能提供力学固定，并没有生物功能性作用，比如促进成骨，抑制破骨和等性能。因此，发展新的能够提供力学稳定性同时又具备生物功能性的可降解锚钉有迫切的临床需求。
镁基金属材料被认为是一种新型可降解金属材料。具有如下鲜明的优势：1)可降解性。镁合金具有较低的腐蚀电位，在含有氯离子的人体体液内环境中易发生腐蚀，并以缓慢腐蚀的方式在体内完全降解。2)生物安全性高。Mg作为人体必需的营养元素，成人每天需要摄入镁量为400mg左右。多余量的镁可通过泌尿系统排泄，镁在人体内吸收不会导致血清镁含量的明显升高。3)生物力学性能极佳。镁的密度为1.74g/cm3,与正常的骨组织接近(1.8-2.0g/cm3)。镁合金压缩屈服强度可达100-300MPa。纯镁的弹性模量44.1GPa，稍高于一般骨12-30GPa，可有效缓解传统医用金属材料临床上的“应力遮挡”效应。4)可抑制破骨促进成骨。镁合金降解后局部pH值升高以及降解后局部镁离子浓度的升高均能显著抑制破骨细胞功能，增加成骨细胞活性。微环境中氢氧根离子数量增加，能够增加具有成骨相关生物活性的羟基磷灰石的产生。5)。由于镁合金降解过程中的pH值升高，以及可以释放抑菌相关的金属离子。
因此，本领域的技术人员致力于开发一种镁基金属带线锚钉及其植入装置，用于任何需要将软组织与骨进行重建的关节。
发明内容
有鉴于现有技术的上述缺陷，本发明所要解决的技术问题是如何设计一种锚钉及其植入装置，具有力学强度高，植入方便等特点。
为实现上述目的，本发明提供了一种镁基金属带线锚钉，包括锚钉本体、植入棒和牵引线，所述锚钉本体为燕尾形，所述锚钉本体上设有栓孔，所述植入棒为管状，所述牵引线被配置为穿过所述植入棒和所述栓孔连接，所述植入棒与所述锚钉本体固定连接。
进一步地，所述燕尾形的角度为30-70度。
进一步地，所述栓孔为1-3个。
进一步地，所述固定连接为螺纹连接。
进一步地，所述燕尾形的尾部最宽长度为1-30mm。
本发明还提供了配合上述任一一种所述镁基金属带线锚钉的植入装置，所述植入装置为中空的套筒，近端具有握持部，远端具有梯形斜面，所述中空的部位被配置为插入所述带线锚钉和植入棒；当抽拉所述牵引线时，所述梯形斜面被配置为撑开所述锚钉本体的燕尾形的燕尾。
进一步地，所述握持部为握柄。
进一步地，所述牵引线为缝线。
进一步地，所述梯形斜面的延长面角度为30-90度。
进一步地，所述梯形斜面的延长面的角度大于所述燕尾形的角度。
本发明所述锚钉设计为燕尾形，燕尾形锚钉尾端具有一个孔以穿过用于提拉的线，两个头端突起将其打磨成尖状。植入装置的远端为中空梯形，其角度与燕尾形燕尾形锚钉角度相同。两者相互接触并且在拉应力的作用下使得燕尾形燕尾形锚钉两个尖状头端插入周围骨组织以起到锚钉的固定作用。该镁基金属带线锚钉抗拔出力强。可在生物体内降解吸收且降解速率可控，具有良好的生物相容性，良好的骨整合能力。
以下将结合附图对本发明的构思、具体结构及产生的技术效果作进一步说明，以充分地了解本发明的目的、特征和效果。
附图说明
图1是本发明的一个较佳实施例的镁基金属带线锚钉；
图2是本发明的一个较佳实施例的植入装置；
图3是本发明的一个较佳实施例的带线锚钉与植入装置的组合示意图；
图4是本发明的一个较佳实施例的锚钉植入骨质示意图；
其中，1-锚钉；2-植入棒；3-缝线；4-栓孔；5-握柄；6-通孔；7-套筒。
具体实施方式
本发明的可降解镁基金属带线锚钉及其植入装置，镁基金属需采用高纯度的原材料和高洁净度的熔炼技术来制造。经热处理和形变加工后制成所需的燕尾形，如图1所示。燕尾形角度为30-70°。燕尾形最宽处长度为1-30mm，远端中间有1-3个孔用于穿缝线，燕尾形凹部有螺纹，用于固定植入锚钉用的插入棒。植入装置如图2所示，为一个中空的套筒，中空部位用于穿过插入棒和缝线。近端有中空握柄，远端形状为梯形，梯形俩斜面延长面的角度为30-90°，如图3所示。
镁基金属可为纯镁或者镁合金。纯镁按重量百分比，纯度≥95％。镁合金按重量百分比计，含有下列微量元素的一种或几种，它们为铜、锌、锰、硒、锶、钙、铁、锆、锡、镍、铝、银、钪、钇、镧、铈、镨、钕、钜、钐、铕、钆、铽、镝、钬、铒、铥、镱、镥。按重量百分比计，总量为0-5％。
实际操作中，如图4所示，我们首先在撕脱的骨部位钻孔，然后先将带线锚钉用插入棒插入孔道底端。将套筒穿过插入棒和缝线顶入孔道，遇到阻力后说明锚钉和套筒远端接触。最后拧出插入棒，用力提拉缝线，使锚钉俩尖端插入旁边骨质以达到锚钉固定的作用。
本发明的可降解镁基金属带线锚钉及其植入装置具有如下优点：
1、力学强度。镁的密度为1.74g/cm3,与正常的骨组织接近(1.8-2.0g/cm3)。镁合金压缩屈服强度可达100-300MPa。纯镁的弹性模量44.1GPa，稍高于一般骨12-30GPa，可有效缓解传统医用金属材料临床上的“应力遮挡”效应。可用于骨质疏松患者。与聚乳酸相比，没有断裂的风险。
2、植入装置的套筒远端的梯形所形成的角度大于燕尾形角度，提拉后可以使得燕尾形尖端插入周围骨质。
4、具有生物功能性。镁基金属能够有效促进成骨抑制破骨，锚钉固定后能够促进周围骨质成骨，强化固定。
本发明的实施例采用高纯度的原材料和高洁净度的熔炼技术来制造。抗拉强度210Mpa，延伸率10％。经热处理和形变加工进一步制成燕尾形锚钉。燕尾形角度为70°。燕尾形最宽处长度为20mm，远端中间有个孔用于穿缝线，燕尾形凹部有螺纹，用于固定植入锚钉用的插入棒。植入装置为一个中空的套筒，中空部位用于穿过插入棒和缝线。近端有中空握柄，远端形状为梯形，梯形俩斜面延长面的角度为90°。
生物安全性
按照GB/T16886所述实验方法进行生物学评价。实验结果表明，本实施例材料对成骨细胞和骨髓间充值干细胞没有明显的细胞毒性和凝血性，没有明显的致敏、刺激和遗传毒性。
体内实验及材料降解情况
试验动物选用12只山羊.术中直接取肩关节正中切口,解剖分离出冈上肌腱,于止点处锐性切断,造成山羊冈上肌腱撕脱动物模型。实验组采用镁基金属带线锚钉及其植入装置重建，对照组用聚乳酸带线锚钉重建。分别在术后第4、8、12周三个时间点取材,进行放射学、大体形态和组织切片检查,观察冈上肌腱的腱-骨愈合情况及骨锚钉的组织学转归.结果显示。实验组术后组织反应小，无炎症反应。放射学显示实验组锚钉在各个时间点逐步与周围骨质融合明显优于对照组。HE染色检查显示在第12周时实验组锚钉与周围骨质完全融合。材料8、12周分别降解10％、30％。
以上详细描述了本发明的较佳具体实施例。应当理解，本领域的普通技术无需创造性劳动就可以根据本发明的构思作出诸多修改和变化。因此，凡本技术领域中技术人员依本发明的构思在现有技术的基础上通过逻辑分析、推理或者有限的实验可以得到的技术方案，皆应在由权利要求书所确定的保护范围内。
Claims (3)
1.一种镁基金属带线锚钉的植入装置，其特征在于，所述植入装置为中空的套筒，近端具有握持部，远端具有梯形斜面；所述中空的套筒的中空部位用于穿过植入棒和缝线；所述带线锚钉由锚钉本体、所述植入棒和所述缝线组成；所述锚钉本体为燕尾形；所述燕尾形的角度为30-70度；所述锚钉本体上设有栓孔；所述植入棒为管状；所述缝线被配置为穿过所述植入棒和所述栓孔连接；所述植入棒与所述锚钉本体固定连接；当抽拉所述缝线时，所述梯形斜面被配置为撑开所述锚钉本体的燕尾形的燕尾，所述梯形斜面的延长面的角度大于所述燕尾形的角度；所述握持部具有通孔，所述通孔供所述植入棒插入。
2.如权利要求1所述的植入装置，其特征在于，所述握持部为握柄。
3.如权利要求1所述的植入装置，其特征在于，所述梯形斜面的延长面角度为30-90度。
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| EP0734230B1 (en) * | 1993-12-13 | 2003-09-10 | Ethicon, Inc. | Suture anchor device |
| EP1345546B1 (en) * | 2000-12-22 | 2009-03-25 | United States Surgical Corporation | Suture screw |
| CN203208108U (zh) * | 2013-04-10 | 2013-09-25 | 爱宝骨科有限公司 | 一种医用可降解吸收镁合金骨钉及配套工具 |
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