CN116269868A - 一种用于牙槽骨再生的口腔修复膜及其制备方法 - Google Patents
一种用于牙槽骨再生的口腔修复膜及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种用于牙槽骨再生的口腔修复膜,由依次贴合的上层膜、中层膜和下层膜组成,其中,上层膜的厚度为0.02~0.50mm,其上均布的孔的孔径为15~400μm;中层膜的厚度为0.05~1.00mm,其上均布的孔的孔径为1~20μm;下层膜的厚度为0.02~0.50mm,其上均布的孔的孔径为100~500μm。本发明在牙槽骨再生过程中起屏障作用,防止软组织长入骨缺损区域和促进牙槽骨再生。
Description
技术领域
本发明涉及口腔修复膜。
背景技术
牙龈和牙槽骨等牙周组织能维持牙齿的结构稳定性,在维护口腔健康方面起到了重要作用。由于大部分人对口腔清洁的重视程度不够,口腔清洁不彻底不仅仅会损害牙齿本身,还会导致菌斑堆积,引发牙龈炎,从而损害牙周组织。如不进行治疗,牙龈炎会转变成牙周炎,进而损害牙槽骨。当骨质丧失严重时,牙齿不再牢固,最终脱落。种植牙手术同样要求缺牙部位有足够的牙槽骨量,这是手术成功的关键。
牙槽骨可以再生和修复,但牙周软组织比牙槽骨的再生速度快,占用了骨质再生所需的空间。因此,为确保骨质再生空间,引导骨再生(guidedbone regeneration,GBR)技术是临床上使用的主要策略。具体而言,是将屏障膜覆盖在骨缺损区的骨组织表面,将软组织与骨组织隔开,防止上皮细胞以及结缔组织来源的成纤维细胞长入缺损区,使骨缺损局部的骨诱导因子含量相对增加,诱导骨生长、填充骨缺损。其中屏障膜是GBR技术的关键,其结构和性能直接影响骨再生的效果。
一般在骨缺损处填充骨修复材料,再以屏障膜覆盖,建立一个局部封闭的空间。骨修复材料和屏障膜协同作用,防止软组织长入和促进骨再生。最初使用的屏障膜是以聚四氟乙烯材料为代表的不可吸收屏障膜,该类材料具有稳定性且具有引导骨再生的效果,但由于其不可降解,需要手术取出,会给患者带来不必要的伤害。因此目前的研究和应用逐渐趋向于可吸收屏障膜。临床上使用的可吸收材料中,以天然材料胶原和合成聚酯类材料为代表。然而,胶原降解迅速,在成骨初期便已失去作用,同时医用胶原多取自牛、猪等动物,存在免疫原性和感染动物源性疾病的风险。聚乳酸等合成聚酯类材料因具有适宜且可调的降解速率和安全性,受到越来越多研究者和患者的青睐。
膜状材料的成型方式一般有静电纺丝法、相转化法、超临界流体法、自组装法等,其中,静电纺丝技术操作简便,制备得到的膜材料具有三维的微观结构及可调节的孔径和孔隙率,在生物医用领域应用广泛。公开号CN109513046A的专利提出了一种可吸收的口腔修复膜,采用明胶和PCL为原料,利用静电纺丝工艺制备纳米纤维膜,并按照明胶-PCL-明胶层的顺序进行热压合,得到纤维直径渐变的三层结构口腔修复膜。然而,多层结构的实现依赖于后续的压合处理,增加了运行成本;虽为渐变结构,但变的是纤维直径,而实际对细胞行为起着关键诱导作用的是膜的孔结构,因此该口腔修复膜的实际效果有待验证。
综上,提供一种兼具屏障作用和成骨作用、降解速率与组织再生速率相匹配、安全性高且成本较低的用于牙槽骨再生的口腔修复膜,是存在牙周疾病及有种植牙需求的患者迫切需要的。
发明内容
本发明的目的在于提供一种用于牙槽骨再生的口腔修复膜,在牙槽骨再生过程中起屏障作用,防止软组织长入骨缺损区域和促进牙槽骨再生。
实现上述目的的技术方案是:
一种用于牙槽骨再生的口腔修复膜,由依次贴合的上层膜、中层膜和下层膜组成,其中,
上层膜的厚度为0.02~0.50mm,其上均布的孔的孔径为15~400μm;
中层膜的厚度为0.05~1.00mm,其上均布的孔的孔径为1~20μm;
下层膜的厚度为0.02~0.50mm,其上均布的孔的孔径为100~500μm。
优选的,口腔修复膜通过静电纺丝技术制备。
优选的,植入后,上层膜与牙周软组织接触并供软组织攀附,下层膜朝向骨缺损区域。
优选的,上层膜、中层膜和下层膜各自的孔隙率均大于50%。
优选的,下层膜采用高分子/生物陶瓷复合材料或负载有成骨活性因子的合成聚合物。
优选的,口腔修复膜采用合成高分子材料,合成高分子材料为可降解聚酯,包括:聚乳酸、乙醇酸、丙交酯-乙交酯共聚物、聚己内酯或其任意组合。
一种用于牙槽骨再生的口腔修复膜的制备方法,包括:
将合成高分子材料溶于有机溶剂中,配制静电纺丝液;
使用静电纺丝设备将静电纺丝液制备成口腔修复膜;
将口腔修复膜裁剪至适宜尺寸,置于真空干燥箱中进行真空干燥;
将口腔修复膜裁剪至所需尺寸,进行灭菌、包装。
优选的,合成高分子材料为可降解聚酯,包括:聚乳酸、乙醇酸、丙交酯-乙交酯共聚物、聚己内酯或其任意组合。
优选的,静电纺丝液的浓度为10~30%;
真空干燥的干燥温度为20~60℃,干燥时间为5~48h。
优选的,在静电纺丝设备中添加静电纺丝液,输入参数后启动,依次制备上层膜、中层膜和下层膜;
上层膜对应的参数为:正压1~7V,负压-14~-19V,推胶流速10~50mL/h,推胶量1~15mL;
中层膜对应的参数为:正压7~13V,负压-9~-15V,推胶流速1~10mL/h,推胶量3~20mL;
下层膜对应的参数为:正压9~16V,负压-1~-8V,推胶流速30~70mL/h,推胶量1~15mL。
本发明的有益效果是:本发明具有分层结构,各层承担不同的功能,可以避免软组织长入从而维持骨再生的空间,同时促进骨组织再生。本发明通过静电纺丝技术制备,连续纺丝的过程通过调整纺丝参数得到不同结构的单层膜,溶剂的存在使各层膜自然粘合,不需要经过额外的后处理就可以得到结构稳定的多层结构膜,使用过程中不容易出现膜间相互分离或者某层膜被剥离的现象。本发明以合成高分子材料为原料,植入缺损部位后可吸收,不需要二次手术取出,减少了患者的负担。同时合成高分子材料相比于市场上广泛使用的胶原材料,安全性更高且价格低廉,更容易被患者接受。
附图说明
图1是本发明的用于牙槽骨再生的口腔修复膜的结构示意图;
图2是本发明的口腔修复膜的微观结构图;
图3是本发明的口腔修复膜各层的厚度、孔径和孔隙率数据表;
图4是本发明的口腔修复膜的临床疗效数据表。
具体实施方式
下面将结合附图对本发明作进一步说明。
针对拔牙或牙周病导致的牙槽骨量不足从而影响口腔健康和降低种植成功率的问题,本发明提供了一种用于牙槽骨再生的口腔修复膜,通过静电纺丝技术制备,由依次贴合的上层膜、中层膜和下层膜组成。如图1所示。
上层膜的厚度为0.02~0.50mm,其上均布的孔的孔径为15~400μm;植入后与牙周软组织接触,供软组织攀附以在愈合早期便覆盖创口,防止食物残渣进入创口,减少炎症隐患。
中层膜的厚度为0.05~1.00mm,其上均布的孔的孔径为1~20μm;中层为关键的屏障层,小孔径的特点使得该层可以起到有效阻隔的作用,防止软组织向内生长进入骨缺损区域。
下层膜的厚度为0.02~0.50mm,其上均布的孔的孔径为100~500μm。植入后朝向骨缺损区域,疏松多孔,利于骨细胞粘附和迁移,促进骨组织再生。
三层膜厚度适中,不易变形和坍塌,既可以起到支撑作用,又不会由于整膜厚度过大而导致降解缓慢。
上层膜、中层膜和下层膜各自的孔隙率均大于50%。不影响膜内外的气体等小分子物质的交换,避免降解形成的气体产物集中,诱发炎症反应。
另外实施例中,下层膜可以采用高分子/生物陶瓷复合材料或负载有成骨活性因子的合成聚合物。生物陶瓷降解产生钙离子和磷酸根离子,可被成骨细胞吸收后合成天然骨中的无机成分。活性因子可有效促进成骨。
本发明的用于牙槽骨再生的口腔修复膜的制备方法,包括下列步骤:
1)溶液的配制:将合成高分子材料溶于有机溶剂中,搅拌使材料完全溶解,配制静电纺丝液。合成高分子材料为可降解聚酯,包括:聚乳酸(PLA)、乙醇酸(PGA)、丙交酯-乙交酯共聚物(PLGA)、聚己内酯(PCL)等或其任意组合。静电纺丝液的浓度为10~30%。
本实施例中,将聚乳酸溶于二氯甲烷中,置于磁力搅拌器上,搅拌使材料完全溶解,配制浓度为20%的静电纺丝液。
2)膜的制备:使用静电纺丝设备将静电纺丝液制备成口腔修复膜。具体地,在静电纺丝设备中添加静电纺丝液,输入参数后启动,依次制备上层膜、中层膜和下层膜。制备过程中,
上层膜对应的参数为:正压1~7V,负压-14~-19V,推胶流速10~50mL/h,推胶量1~15mL;
中层膜对应的参数为:正压7~13V,负压-9~-15V,推胶流速1~10mL/h,推胶量3~20mL;
下层膜对应的参数为:正压9~16V,负压-1~-8V,推胶流速30~70mL/h,推胶量1~15mL。
本实施例中,打开静电纺丝机,添加适量静电纺丝液于针筒中,输入参数:正压2V,负压-18V,推胶流速10mL/h,推胶量10mL,启动,第一层制备完成后更改参数为:正压8V,负压-14V,推胶流速1mL/h,推胶量20mL,制备第二层,再更改参数为:正压10V,负压-7V,推胶流速30mL/h,推胶量10mL,第三层制备完成,得到口腔修复膜。
3)膜的干燥:将口腔修复膜裁剪至适宜尺寸,置于真空干燥箱中进行真空干燥。真空干燥的干燥温度为20~60℃,干燥时间为5~48h。
本实施例中,将膜一分为四,置于真空干燥箱中,固定,50℃下干燥24h。
4)膜的处理:将口腔修复膜裁剪至所需尺寸,进行灭菌、包装。本实施例中,用模切机将膜裁剪至20mm*20mm尺寸,包装后用环氧乙烷进行灭菌。
成品的口腔修复膜的微观结构见图2,可见纤维交错形成的多孔结构。实验现象表明,电场强度在上述范围内时,聚合物液体可以稳定成纤,形成的纤维膜结构稳定性高、力学性能满足使用要求。孔尺寸可通过改变静电纺丝参数进行调控,随推胶流速的减小,纤维之间的堆积更为密集,形成的孔尺寸更小。推胶量则影响膜的厚度,推胶量越大,膜的厚度也越大,支撑性能相对更好。
使用方式:取口腔修复膜,在室温下放置使其温度平衡;设置切口,翻瓣使缺损部位完全暴露,去除骨表面的肉芽组织;打开包装,取出口腔修复膜,根据手术需要,使用剪刀裁剪成所需的形状和大小,边缘休整圆钝;根据手术需要填充骨修复材料;识别口腔修复膜的上层和下层,将下层朝向骨缺损一面,同时确保口腔修复膜完全覆盖并超过骨缺损区域3mm以上;放置完成后对切口进行缝合。
附图3为口腔修复膜各层的厚度、孔径和孔隙率数据,由压汞法测试得到。为适应不同的需求从而实现不同的功能,各层孔径不同。上层植入后与软组织接触,孔径较大,利于成纤维细胞粘附和迁移,可供软组织攀附以在愈合早期便覆盖创口,防止食物残渣进入创口,减少炎症隐患;中层结构致密,起阻隔作用,防止软组织长入骨缺损区域,维持骨再生的空间;下层植入后与面向骨缺损区域,较大的孔径利于骨细胞粘附和迁移,利于骨组织的再生。三层均具有较高的孔隙率,在60%-80%范围内,不影响膜内外的气体等小分子物质的交换。
附图4为口腔修复膜的临床疗效数据。种植同期行GBR术,即在种植体周围骨缺损区域植入骨修复材料,并比屏障膜覆盖。实验组选用本发明提出的口腔修复膜,对照组为市场上使用广泛的胶原膜。影像学测量数据显示,屏障膜的使用减少了骨组织的吸收,更为有效地保存了牙槽骨的体积,并在一定程度上促进了骨再生。虽然胶原膜在成骨初期的骨修复效果接近或优于本发明提出的口腔修复膜,但其降解过快,未完成骨重建时便已经失去屏障作用,引导骨再生的作用也随之消失。由此可见,本发明提出的口腔修复膜具有很好的临床疗效。
以上实施例仅供说明本发明之用,而非对本发明的限制,有关技术领域的技术人员,在不脱离本发明的精神和范围的情况下,还可以作出各种变换或变型,因此所有等同的技术方案也应该属于本发明的范畴,应由各权利要求所限定。
Claims (10)
1.一种用于牙槽骨再生的口腔修复膜,其特征在于,由依次贴合的上层膜、中层膜和下层膜组成,其中,
上层膜的厚度为0.02~0.50mm,其上均布的孔的孔径为15~400μm;
中层膜的厚度为0.05~1.00mm,其上均布的孔的孔径为1~20μm;
下层膜的厚度为0.02~0.50mm,其上均布的孔的孔径为100~500μm。
2.根据权利要求1所述的用于牙槽骨再生的口腔修复膜,其特征在于,口腔修复膜通过静电纺丝技术制备。
3.根据权利要求1所述的用于牙槽骨再生的口腔修复膜,其特征在于,植入后,上层膜与牙周软组织接触并供软组织攀附,下层膜朝向骨缺损区域。
4.根据权利要求1所述的用于牙槽骨再生的口腔修复膜,其特征在于,上层膜、中层膜和下层膜各自的孔隙率均大于50%。
5.根据权利要求1所述的用于牙槽骨再生的口腔修复膜,其特征在于,下层膜采用高分子/生物陶瓷复合材料或负载有成骨活性因子的合成聚合物。
6.根据权利要求1所述的用于牙槽骨再生的口腔修复膜,其特征在于,口腔修复膜采用合成高分子材料,合成高分子材料为可降解聚酯,包括:聚乳酸、乙醇酸、丙交酯-乙交酯共聚物、聚己内酯或其任意组合。
7.一种用于牙槽骨再生的口腔修复膜的制备方法,其特征在于,包括:
将合成高分子材料溶于有机溶剂中,配制静电纺丝液;
使用静电纺丝设备将静电纺丝液制备成口腔修复膜;
将口腔修复膜裁剪至适宜尺寸,置于真空干燥箱中进行真空干燥;
将口腔修复膜裁剪至所需尺寸,进行灭菌、包装。
8.根据权利要求7所述的制备方法,其特征在于,合成高分子材料为可降解聚酯,包括:聚乳酸、乙醇酸、丙交酯-乙交酯共聚物、聚己内酯或其任意组合。
9.根据权利要求7所述的制备方法,其特征在于,静电纺丝液的浓度为10~30%;
真空干燥的干燥温度为20~60℃,干燥时间为5~48h。
10.根据权利要求7所述的制备方法,其特征在于,在静电纺丝设备中添加静电纺丝液,输入参数后启动,依次制备上层膜、中层膜和下层膜;
上层膜对应的参数为:正压1~7V,负压-14~-19V,推胶流速10~50mL/h,推胶量1~15mL;
中层膜对应的参数为:正压7~13V,负压-9~-15V,推胶流速1~10mL/h,推胶量3~20mL;
下层膜对应的参数为:正压9~16V,负压-1~-8V,推胶流速30~70mL/h,推胶量1~15mL。
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