CN113633827A - 一种蚕丝编织型半月板植入体及其制备方法 - Google Patents
一种蚕丝编织型半月板植入体及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种蚕丝编织型半月板植入体及其制备方法。采用蚕丝作为编织材料，经过骨胶灌注成型制备而成。本发明采用立体编织技术实现了蚕丝的机械化一体编织，使编织体的精准化成型成为可能，易于工业化生产；采用同种异体骨胶为成型灌注材料，具有更好的生物相容性；采用脱钙骨粉作为骨胶的制备原料，成型后的半月板具有多孔，利于周围营养物质的附着，利于伤口愈合。
Description
技术领域
本发明属于半月板修复材料制备技术领域，具体涉及一种蚕丝编织型半月板植入体及其制备方法。
背景技术
2018年医景网站统计结果显示，半月板损伤已成为最常见的膝关节损伤，急性半月板撕裂的患病率达61例/100 000人。半月板重建术成为损伤修复领域科研人员的研究热点之一，其主要方式包括同种异体半月板移植和人工替代物移植。同种异体半月板移植可有效缓解患者疼痛并改善膝关节功能，但其却存在着移植物来源不足、组织保存困难等问题。人工半月板植入体材料分为两类天然材料和合成材料。
美国vy Sports Medicine公司对胶原蛋白半月板移植物(collagen meniscusimplant，CMI)
进行商业投资和研发。该产品可生成新组织且无毒副作用，有效改善患者临床症状和膝关节临床评分；但力学性能达不到维持膝关节正常功能要求，该商品仅适用于半月板外周边缘仍未受损的病例。英国Qrteq公司展开了进一步的研发，制备出一种孔径为150～335μm、孔隙率为80％的聚己内酯/聚氨酯半月板支架
该产品可降低胫骨平台所受的压力，促进组织生长并保护关节软骨，改善患者膝关节临床评分；但聚氨酯可能会产生少量可降解的有毒二元胺。
美国Active Implants公司研制出一种商品化的长期替代型聚碳酸酯聚氨酯(polycarbonate urethane，PCU)半月板移植物
该产品具有良好的生物力学性，由于复合结构和设计，人工半月板不需要固定到骨或软组织上。由牛津生物材料有限公司公开了一种可植入软骨组织修复装置(200680038582.6)，由蚕丝经缠绕或编织或压缩毡或捻合或针织或编结或缝合或刺绣或结合布层中的一种或多种方法形成立体纤维层，浇注水凝胶，水凝胶包括明胶、纤维蛋白、透明质酸、藻酸盐等。南京大学医学部附属鼓楼医院公开了一种医用膝关节半月板(200720131799.3)，设计的半月板由蚕丝通过钩编而成，并包裹I型胶原。北京航空航天大学申公开了一种基于纤维编织结构的人工半月板支架及其编织方法(201710999938.2)，半月板支架由蚕丝经传统编织方法单层编织后层层堆积串联而成，并通过浇注方式固形，包裹固形材料如胶原、聚乙烯醇水凝胶、聚氨酯。上述采用水凝胶、I型胶原和胶原等材料组织相容性较差，力学性能不佳。
发明内容
本发明的目的在于提供一种蚕丝编织型半月板植入体及其制备方法。
一种蚕丝编织型半月板植入体，采用蚕丝作为编织材料，经过骨胶灌注成型制备而成。
一种蚕丝编织型半月板植入体的制备方法，按照如下步骤进行：
(1)选用蚕丝作为编织材料，基于缝编技术，将连续的蚕丝纤维经多层平直铺放并进行Z向缝合而形成定向立体织物，该编制体外形特征为半环的C型或O型，纵截面为外侧高内侧低的楔形结构；
(2)将步骤(1)制备的蚕丝编织支架浸没在碳酸钠水溶液中，于80-120℃脱胶10-30分钟，温水清洗1-3次，重复1-6次；
(3)取同种异体皮质骨或松质骨，经过打粉、脱钙、清洗及冻干后制备为脱钙骨粉；
(4)将脱钙骨粉与纯化水混合，在高压灭菌锅中，100-110℃蒸煮3-8小时形成骨胶；
(5)将步骤(2)制备的蚕丝编织放入具有半月板外形凹槽的模具内，浇注骨胶，真空浸润，冷冻干燥成型。
步骤(1)所述蚕丝的直径为0.2-0.8mm。
所述多层为2-20层。
所述碳酸钠水溶液的浓度为0.01-0.05M。
所述步骤(4)所述脱钙骨粉：纯化水比例为1：(1-5)。
本发明的有益效果：本发明采用立体编织技术实现了蚕丝的机械化一体编织，使编织体的精准化成型成为可能，易于工业化生产。本发明采用同种异体骨胶为成型灌注材料，具有更好的生物相容性。采用脱钙骨粉作为骨胶的制备原料，成型后的半月板具有多孔，利于周围营养物质的附着，利于伤口愈合。
附图说明
图1为细胞毒性试验结果。
图2为石蜡切片显微镜下观察结果。
图3为编织体支架与人半月板的刚度和弹性模量。
具体实施方式
为了便于理解本发明，下面将对本发明进行更全面的描述。但是，本发明可以以许多不同的形式来实现，并不限于本文所描述的实施例。相反地，提供这些实施例的目的是使对本发明的公开内容的理解更加透彻全面。
实施例1蚕丝编织型半月板植入体的制备
1、蚕丝编织
编织：选用纤维直径0.5mm的蚕丝作为编织材料，基于缝编技术，将连续的蚕丝纤维经5层平直铺放并进行Z向缝合而形成的定向立体织物，该编制体外形特征为半环的C型，纵截面为外侧高内侧低的楔形结构。
脱胶：蚕丝编织支架在0.02M碳酸钠水溶液中100℃脱胶20分钟，温水清洗2次，重复3次。
2、骨胶制备
脱钙骨制备：同种异体皮质骨经过打粉、脱钙、清洗及冻干后制备为脱钙骨粉；
骨胶制备：按照脱钙骨粉：纯化水比例为1：3.5，在高压灭菌锅中，105℃蒸煮5小时形成骨胶。
3、复合成型
将编织支架放入具有半月板外形凹槽的模具内，浇注骨胶，真空浸润，冷冻干燥成型。
实施例2
1、蚕丝编织
编织：选用纤维直径0.5mm的蚕丝作为编织材料，基于缝编技术，将连续的蚕丝纤维经5层平直铺放并进行Z向缝合而形成的定向立体织物，该编制体外形特征为O型，纵截面为外侧高内侧低的楔形结构。
脱胶：蚕丝编织支架在0.02M碳酸钠水溶液中100℃脱胶20分钟，温水清洗2次，重复3次。
2、骨胶制备
脱钙骨制备：同种异体松质骨经过打粉、脱钙、清洗及冻干后制备为脱钙骨粉；
骨胶制备：按照脱钙骨粉：纯化水比例为1：3.5，在高压灭菌锅中，105℃蒸煮5小时形成骨胶。
3、复合成型
将编织支架放入具有半月板外形凹槽的模具内，浇注骨胶，真空浸润，冷冻干燥成型。
实验例1：材料细胞毒性试验：
实验方法：将实施例1制备的编织体支架制备成方形体，材料灭菌后，按照浸提比例3cm2/ml(表面积/体积)加入高糖DMEM培养基，浸泡24小时。将L929细胞按照4×104/孔接种于96孔板内，24小时后，实验组每孔加入100ul浸提液，对照组加入正常培养基。24小时后用CCK8法检测各组细胞活力。
检测结果如图1所示，对照组与实验组细胞活力相当，差异无统计学意义。
实验例2：支架体内植入实验及组织学观察
实验方法：
①将实施例1制备的编织体半月板制备成兔半月板形状，支架辐照灭菌备用。
②兔内侧半月板完全缺损模型建立及支架植入：
10％水合氯醛按1.5ml/kg耳缘静脉注射新西兰大耳兔。待麻醉后将兔仰卧位固定于解剖台上，左后腿皮肤消毒，无菌手套包裹兔足，铺无菌单。取膝关节前内侧切口，逐层切开皮肤、皮下组织，打开关节囊，将髌骨外翻，游离半月板周围软组织。暴露并游离内侧半月板，并将内侧半月板完全切除，构建兔内侧半月板完全缺损模型。植入编织体半月板，将编织体前角及后角缝合于交叉韧带上，外周缝合于周围软组织。依次缝合皮下组织及皮肤。
③于体内植入后2月，处死实验动物，取下编织体半月板支架及对侧正常内侧半月板。实验标本经固定、脱水、石蜡包埋、切片，对标本切片进行HE染色，显微镜下观察。
观察结果如图2所示，支架体内可见成纤维样细胞生长于蚕丝纤维上，可见新生血管形成，未见明显炎性细胞分布，材料降解无明显降解。
实验例3：材料力学性能检测及结果
实验方法：取人半月板及实施例1制备的编织体支架，剥离标本周围多余的脂肪等组织，放置在万能力学试验机进行压缩试验。
检测结果如图3，编织体支架与人半月板两者刚度及弹性模量相当，差异无统计学意义。
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。
Claims (6)
1.一种蚕丝编织型半月板植入体，其特征在于，采用蚕丝作为编织材料，经过骨胶灌注成型制备而成。
2.一种蚕丝编织型半月板植入体的制备方法，其特征在于，按照如下步骤进行：
(1)选用蚕丝作为编织材料，基于缝编技术，将连续的蚕丝纤维经多层平直铺放并进行Z向缝合而形成定向立体织物，该编制体外形特征为半环的C型或O型，纵截面为外侧高内侧低的楔形结构；
(2)将步骤(1)制备的蚕丝编织支架浸没在碳酸钠水溶液中，于80-120℃脱胶10-30分钟，温水清洗1-3次，重复1-6次；
(3)取同种异体皮质骨或松质骨，经过打粉、脱钙、清洗及冻干后制备为脱钙骨粉；
(4)将脱钙骨粉与纯化水混合，在高压灭菌锅中，100-110℃蒸煮3-8小时形成骨胶；
(5)将步骤(2)制备的蚕丝编织放入具有半月板外形凹槽的模具内，浇注骨胶，真空浸润，冷冻干燥成型。
3.根据权利要求2所述蚕丝编织型半月板植入体的制备方法，其特征在于，步骤(1)所述蚕丝的直径为0.2-0.8mm。
4.根据权利要求2所述蚕丝编织型半月板植入体的制备方法，其特征在于，所述多层为2-20层。
5.根据权利要求2所述蚕丝编织型半月板植入体的制备方法，其特征在于，所述碳酸钠水溶液的浓度为0.01-0.05M。
6.根据权利要求2所述蚕丝编织型半月板植入体的制备方法，其特征在于，所述步骤(4)所述脱钙骨粉：纯化水比例为1：(1-5)。
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