CN114940747A - 一种具有形状记忆功能的面部填充剂及其应用 - Google Patents
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Abstract
本发明属于医疗美容技术领域,尤其涉及一种具有形状记忆功能的高分子材料面部填充剂及其应用,该面部填充剂为由丙三醇、十二烷二酸缩聚得到的高分子聚合物,其中丙三醇、十二烷二酸的体积比为1:1~5。可将该高分子材料面部填充剂应用在面部缺陷修复中。本发明的有益效果是:本发明的面部填充剂为一种高分子聚合物,具有形状记忆功能,力学性能与自身组织几乎无差别,免疫原性低,可被自体完全降解。
Description
技术领域
本发明属于医疗美容技术领域,尤其涉及一种具有形状记忆功能的面部填充剂及其应用。
背景技术
爱美之心人皆有之,随着社会经济水平的不断提高,人民对自身面部缺陷部位的修复诉求愈发强烈,越来越多的人选择使用面部填充手段进行面部特征调整及重塑。
目前的面部填充剂一般分为两种,假体类及注射类,均以高分子材料居多。但假体类普遍力学性能与自体组织相差甚远,患者术后通常会出现表情不自然或术后满意度较差的情况;且因假体类材料过硬,容易出现填充材料与自体组织的磨损,导致炎症反应的发生;假体类材料一般不可降解,术后十到十五年后一般需要重新手术取出。而注射类材料,一般力学性能较差,可降解类材料一般降解速度过快,不可降解类材料极难取出,易游离,炎症反应强烈,且术中具有填充部位不当及堵塞血管的风险。
为此,本发明研究了一种具有形状记忆功能的高分子聚合物作为面部填充剂来解决上述问题。
发明内容
为了克服上述现有技术的不足,本发明提供一种具有形状记忆功能的面部填充剂及其应用,该面部填充剂为一种高分子聚合物,具有形状记忆功能,力学性能与自身组织几乎无差别,免疫原性低,可被自体完全降解。
为了实现上述目的,本发明采用如下技术方案:
一种具有形状记忆功能的面部填充剂,该面部填充剂为由丙三醇、十二烷二酸缩聚得到的高分子聚合物,其中丙三醇、十二烷二酸的体积比为1:1~5。
上述具有形状记忆功能的面部填充剂的制备方法包括如下步骤:
(1)将丙三醇及十二烷二酸按1:1~5的体积比置入三颈烧瓶,在氮气条件下100-200℃搅拌12-48h;
(2)将步骤(1)得到的产物置于真空条件下室温连续搅拌12-48h;
(3)将步骤(2)得到的预聚物置入所需形状的模具中,真空条件下70-120℃保温12-48h;
(4)将步骤(3)的模具及预聚物在真空条件下100-200℃保温12-48h。
优选的,所述步骤(1)中,反应过程不进行小分子的脱除。
优选的,所述步骤(2)-(4)的真空条件需达到90mTorrs以上。
优选的,模具的材质包括但不限于聚四氟乙烯、钛及其合金、镍基合金、陶瓷材料、二氧化硅等。
优选的,丙三醇及十二烷二酸的纯度达分析纯及以上。
一种具有形状记忆功能的面部填充剂在面部修复方面的应用,使用时,在面部需要进行填充或修复部位的真皮下,直接植入本发明制备的面部填充剂。
本发明的有益效果为:本发明使用使用具有形状记忆的高分子材料做为面部填充剂,该材料具有形状记忆功能,回弹迅速,柔韧度高,力学性能与人体组织差别极小,患者术后满意度高。同时,材料可被自体组织完全降解,降解速率适中,降解产物安全,也可在手术不成功的情况下取出,安全性高。材料免疫原性低,不易引发炎症反应。材料本身具有一定黏性,可贴合在植入部位,不会发生游离。
具体实施方式
为了使本发明的目的、技术方案和优点更加清楚,下面将结合实施例对本发明作进一步地详细描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其它实施例,都属于本发明保护的范围。
实施例1
本实施例的具有形状记忆功能的面部填充剂,由丙三醇和十二烷二酸按照体积比1:1合成,其中丙三醇及十二烷二酸的纯度要求达分析纯。
所述面部填充剂的制备方法如下:
(1)将丙三醇及十二烷二酸按1:1的体积比置入三颈烧瓶,在氮气条件下100℃搅拌12h;
(2)将步骤(1)得到的产物置于真空条件下(90mTorrs以上)室温连续搅拌12h;
(3)将步骤(2)得到的预聚物置入所需形状的模具中,真空条件下(90mTorrs)70℃保温12h;
(4)将步骤(3)的模具及预聚物在真空条件(90mTorrs)下100℃保温12h,得到面部填充剂。
实施例2
本实施例的具有形状记忆功能的面部填充剂,由丙三醇和十二烷二酸按照体积比1:3合成,丙三醇及十二烷二酸的纯度要求达分析纯。
所述面部填充剂的制备方法如下:
(1)将丙三醇及十二烷二酸按1:3的体积比置入三颈烧瓶,在氮气条件下120℃搅拌24h;
(2)将步骤(1)得到的产物置于真空条件下(90mTorrs以上)室温连续搅拌24h;
(3)将步骤(2)得到的预聚物置入所需形状的模具中,真空条件下(90mTorrs)100℃保温24h;
(4)将步骤(3)的模具及预聚物在真空条件(90mTorrs)下120℃保温12h,得到面部填充剂。
实施例3
本实施例的具有形状记忆功能的面部填充剂,由丙三醇和十二烷二酸按照体积比为1:5合成,丙三醇及十二烷二酸的纯度要求达分析纯。
所述面部填充剂的制备方法如下:
(1)将丙三醇及十二烷二酸按1:5的体积比置入三颈烧瓶,在氮气条件下200℃搅拌48h;
(2)将步骤(1)得到的产物置于真空条件下(90mTorrs以上)室温连续搅拌48h;
(3)将步骤(2)得到的预聚物置入所需形状的模具中,真空条件(90mTorrs)下200℃保温48h;
(4)将步骤(3)的模具及预聚物在真空条件(90mTorrs)下100℃保温12h,得到面部填充剂。
实施例3
将本实施例的填充剂用于人体试验,本实施例的填充剂制备方法与实施例2的条件相同。使用时,在面部需要进行填充部位的真皮下,直接植入本发明制备的面部填充剂。
于本市某医院选取待试志愿者男女各20人,共计40人,且年龄均在20-45岁之间,将40名志愿者随机分为实验组、对照组1、对照组2、对照组3,每组10人,分别注射面部填充剂。实验组、对照组1、对照组2、对照组3,所采用的面部填充剂分别对应本发明实施例2、某面部填充剂(主要原料为透明质酸)、某面部填充假体(主要原料为硅胶)、患者自体腹部脂肪。该实验为双盲实验,待试志愿者均已签订知情同意书,该实验已通过伦理审查。
实验一个月后对填充效果进行评定,分为有效和无效,有效指填充效果完美、达到被试预期效果,预期效果包括填充形状、填充硬度和术后满意程度、一个月后效果稳定且不反弹;无效指填充效果完美、未达到被试预期效果,预期效果包括填充形状、填充硬度和术后满意程度、或一个月后效果不稳定、或一个月后出现反弹,需要重新进行填充;实验后一周对被试不良反应情况进行检测。得到的实验结果如下表所示:
从上表可得,本发明面部填充剂的效果优于三个对照组,术后不良反应出现次数较少,患者对手术满意度较高。
以上对本发明的实例进行了详细说明,但内容仅为本发明的较佳实施例,不能被认为用于限定本发明的实施范围。凡依本发明申请范围所作的均等变化与改进等,均应仍归属于本发明的专利涵盖范围之内。
Claims (8)
1.一种具有形状记忆功能的面部填充剂,其特征在于该面部填充剂为由丙三醇、十二烷二酸缩聚得到的高分子材料,其中丙三醇、十二烷二酸的体积比为1:1~5。
2.根据权利要求1所述的面部填充剂,其特征在于所述面部填充剂的制备方法包括如下步骤:
(1)将丙三醇及十二烷二酸按1:1~5的体积比在氮气条件下100-200℃反应12-48h;
(2)将步骤(1)得到的产物置于真空条件下室温连续搅拌12-48h;
(3)将步骤(2)得到的预聚物置入所需形状的模具中,真空条件下70-120℃保温12-48h;
(4)将步骤(3)的模具及预聚物在真空条件下100-200℃保温12-48h。
3.根据权利要求2所述的面部填充剂,其特征在于所述步骤(1)中,反应过程不进行小分子的脱除。
4.根据权利要求2所述的面部填充剂,其特征在于所述步骤(2)-(4)的真空条件需达到90mTorrs以上。
5.根据权利要求1所述的面部填充剂,其特征在于模具的材质为聚四氟乙烯、钛及其合金、镍基合金、陶瓷材料、二氧化硅中的至少一种。
6.根据权利要求1所述的面部填充剂,其特征在于丙三醇及十二烷二酸的纯度需达分析纯及以上。
7.一种权利要求1-6所述的面部填充剂在面部修复方面的应用。
8.根据权利要求7所述的应用,其特征在于:在面部需要进行修复的部位,直接将所述面部填充剂作为面部填充材料植入真皮下。
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Citations (4)
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US20060147491A1 (en) * | 2005-01-05 | 2006-07-06 | Dewitt David M | Biodegradable coating compositions including multiple layers |
CN101508772A (zh) * | 2009-03-13 | 2009-08-19 | 哈尔滨工业大学 | 聚酯型生物可降解形状记忆聚合物及其制备方法 |
US20100196322A1 (en) * | 2008-08-01 | 2010-08-05 | Francesco Migneco | Polymer for tissue engineering applications and drug delivery |
CN108003330A (zh) * | 2017-12-15 | 2018-05-08 | 扬州大学 | 一种高性能形状记忆的生物可降解材料 |
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Publication number | Priority date | Publication date | Assignee | Title |
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US20060147491A1 (en) * | 2005-01-05 | 2006-07-06 | Dewitt David M | Biodegradable coating compositions including multiple layers |
US20100196322A1 (en) * | 2008-08-01 | 2010-08-05 | Francesco Migneco | Polymer for tissue engineering applications and drug delivery |
CN101508772A (zh) * | 2009-03-13 | 2009-08-19 | 哈尔滨工业大学 | 聚酯型生物可降解形状记忆聚合物及其制备方法 |
CN108003330A (zh) * | 2017-12-15 | 2018-05-08 | 扬州大学 | 一种高性能形状记忆的生物可降解材料 |
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