CN113521401B - 一种基于形状记忆材料的软组织扩张器及其制备方法 - Google Patents
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Abstract
本发明涉及医疗设备技术领域，具体为一种基于形状记忆材料的软组织扩张器，所述软组织扩张器在体外时具有厚度为一毫米的圆环型结构，所述软组织扩张器在植入前将其剪开并在热水中展开形成厚度为一毫米的长方形薄片，一种基于形状记忆材料的软组织扩张器的制备方法，所述软组织扩张器的制备方法至少包括基于形状记忆环氧树脂材料的制备法和基于形状记忆丙烯酸酯材料的制备法。本发明相比现有技术采用了片状形状记忆材料的设计，旨在减少现有软组织扩张器植入的初期张力，扩大形状记忆扩张器的适应症范围。
Description
技术领域
本发明涉及医疗设备技术领域，具体为一种基于形状记忆材料的软组织扩张器及其制备方法。
背景技术
牙周病是我国常见的牙科疾病之一。其主要特点为能造成进行性牙周组织的破坏，最终导致牙齿脱落。缺牙位点的牙槽骨将会在三个月内出现持续的骨吸收，造成牙槽嵴水平向和垂直向的丧失。在牙槽嵴严重萎缩的情况下，种植体植入前就必须进行骨增量手术以获得足够的空间进行种植。然而，骨增量手术，尤其是垂直骨增量手术及大范围的骨增量手术，存在诸多并发症，其中首要并发症是软组织裂开。软组织裂开会造成骨移植材料的暴露，导致植骨材料感染并对骨增量手术产生负面影响。通过术前植入软组织扩张器对牙龈及黏膜等软组织进行增量，可以有效降低骨增量术后的软组织裂开的发生率，从而为骨增量手术提供较为稳定的预后效果。
但当前的软组织扩张器多以硅酮外壳包裹块状水凝胶为主要结构，并通过钛钉固定其位置。该设计需要进行大面积的组织剥离及翻瓣手术，同时在较为狭小的术区(例如单个前牙缺损位点)植入较为困难，仍具有较大的初期张力。鉴于此，本发明拟提出一种基于形状记忆材料的软组织扩张器及其制备方法以克服上述问题。
发明内容
本发明的目的在于提供一种基于形状记忆材料的软组织扩张器及其制备方法，以解决上述背景技术中提出的问题。
为实现上述目的，本发明提供如下技术方案：
一种基于形状记忆材料的软组织扩张器，其特征在于：所述软组织扩张器在体外时具有厚度为一毫米的圆环型结构，所述软组织扩张器在植入前将其剪开并在热水中展开形成厚度为一毫米的长方形薄片，所述软组织扩张器的制备材料包括形状记忆环氧树脂材料，所述软组织扩张器的制备法至少包括以下步骤：
A1.称取一定量的环氧树脂，在圆底烧瓶中加热至60℃融化；
B1.在步骤A1的基础上加入一定量的聚醚胺、甲基丙烯酸缩水甘油酯，磁力搅拌均匀；
C1.将此反应前驱液倒入软组织扩张器的模具中加热固化，首先在80℃的环境中反应4小时，之后在100℃的环境中反应2小时；
D1.冷却至室温后从模具中取出，制备得到基于形状记忆环氧树脂材料的软组织扩张器。
进一步的，一种基于形状记忆材料的软组织扩张器，其特征在于：所述软组织扩张器的制备方法还包括基于形状记忆丙烯酸酯材料制备法
进一步的，一种基于形状记忆材料的软组织扩张器的制备方法，其特征在于：所述基于形状记忆丙烯酸酯材料的制备法至少包括以下步骤：
A2.将3g丙烯酸异冰片酯、2g丙烯酸甲酯和0.1g 1,6-己二醇二丙烯酸酯混合均匀；
B2.在步骤A2的混合液中，加入0.01g光引发剂双苯基氧化膦，配制前驱液；
C2.将步骤B2中的反应前驱液倒入模具中，放置于紫外光环境中固化60秒，从模具中取出基于形状记忆丙烯酸酯材料的软组织扩张器。
进一步的，一种基于形状记忆材料的软组织扩张器，其特征在于：所述软组织扩张器的形状记忆高分子激发条件为热刺激，所述热刺激的转变温度范围为30-50摄氏度。
进一步的，种基于形状记忆材料的软组织扩张器，其特征在于：所述软组织扩张器可采用的形状记忆高分子体系包括但不限于聚氨酯体系、聚丙烯酸酯体系和环氧树脂体系，所述软组织扩张器的高分子分子开关包括但不限于结晶熔融转变、玻璃化转变、液晶相转变、超分子相互作用和动态共价键的可逆反应。
与现有技术相比，本发明的有益效果是：本发明的组成材料为形状记忆材料。本设计下的软组织扩张器在一定温度(30-50摄氏度)下具有变形能力，整体塑性在体外时为1毫米厚的环形结构。在维持形状的同时冷却，该材料可在室温下记忆该形状，在植入体内后(约37摄氏度)恢复原有形状。
本发明形状在体外为厚度一毫米的圆环型结构，植入前将其剪开并在热水中展开形成厚度一毫米的长方形薄片。在本发明中，由于形状记忆材料在皮下受热可恢复其原有形状，从而对口腔软组织产生适当且持久的张力并诱导软组织扩张，可微创无翻瓣较小张力地植入术区骨膜下或黏膜下。植入过程中不断溶胀并对软组织产生张力，在数周内诱导软组织总量增加，减少后期大范围植骨手术的软组织裂开并发症发生率。
附图说明
图1是本发明中的一种所述基于形状记忆环氧树脂材料的软组织扩张器的制备流程图；
图2是本发明中的一种基于形状记忆丙烯酸酯材料的软组织扩张器的制备流程图；
图3为本发明中的软组织扩张器在热水中展开后的材料形状示意图；
图4是本发明中的未经处理的圆环形的软组织扩张器的结构示意图；
图5为本发明中的软组织扩张器体内植入两周后的形变效果图。
具体实施方式
下面将结合本发明实施例中的附图，对本发明实施例中的技术方案进行清楚、完整地描述，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他实施例，都属于本发明保护的范围。
请参阅图1-图5，本发明提供一种技术方案：
请参阅图3-图4，一种基于形状记忆材料的软组织扩张器，软组织扩张器在体外时具有厚度为一毫米的圆环型结构，软组织扩张器在植入前将其剪开并在热水中展开形成厚度为一毫米的长方形薄片。
一种基于形状记忆材料的软组织扩张器的制备方法，软组织扩张器的制备方法至少包括基于形状记忆环氧树脂材料的制备法和基于形状记忆丙烯酸酯材料的制备法。
具体的，请参阅图1，一种基于形状记忆环氧树脂材料的制备法至少包括以下步骤：
A1.称取一定量的环氧树脂，在圆底烧瓶中加热至60℃融化；
B1.在步骤A1的基础上加入一定量的聚醚胺、甲基丙烯酸缩水甘油酯，磁力搅拌均匀；
C1.将此反应前驱液倒入软组织扩张器的模具中加热固化，首先在80℃的环境中反应4小时，之后在100℃的环境中反应2小时；
D1.冷却至室温后从模具中取出，制备得到基于形状记忆环氧树脂材料的软组织扩张器。
具体的，请参阅图2，一种基于形状记忆丙烯酸酯材料的制备法至少包括以下步骤：
A2.将3g丙烯酸异冰片酯、2g丙烯酸甲酯和0.1g 1,6-己二醇二丙烯酸酯混合均匀；
B2.在步骤A2的混合液中，加入0.01g光引发剂双苯基氧化膦，配制前驱液；
C2.将步骤B2中的反应前驱液倒入模具中，放置于紫外光环境中固化60秒，从模具中取出基于形状记忆丙烯酸酯材料的软组织扩张器。
需要说明的是，本实施例采用的原理要求形状记忆高分子需要具备完整的弹性网络结构以及特定的分子开关。具体形状记忆原理为，在一定刺激条件下激发分子开关，此时高分子具备变形能力，可以适应任何预期的形状。随后关闭分子开关，该特定形状将被临时固定，随后重新加热激活分子开关，形状即可会回复。本实施例下的软组织扩张器的形状记忆高分子激发条件为热刺激，热刺激的转变温度范围为30-50摄氏度。
具体的，软组织扩张器体内植入两周后的形变效果如图5所述，具体原理为形状记忆高分子材料受体温影响不断回弹拱起。
进一步的，本实施例下的软组织扩张器可采用的形状记忆高分子体系包括但不限于聚氨酯体系、聚丙烯酸酯体系和环氧树脂体系，所述软组织扩张器的高分子分子开关包括但不限于结晶熔融转变、玻璃化转变、液晶相转变、超分子相互作用和动态共价键的可逆反应。
其中，可进一步公开的材料数据是，环氧树脂(E44，中国石化总公司)、聚醚胺(D-230，阿拉丁公司)，不经纯化直接使用。丙烯酸异冰片酯(麦克林公司)、丙烯酸甲酯(麦克林公司)、1,6-己二醇二丙烯酸酯(阿拉丁公司)、双(2,4,6-三甲基苯甲酰基)苯基氧化膦(光引发剂819，TCI公司)，不经纯化直接使用。
以上显示和描述了本发明的基本原理、主要特征和本发明的优点。本行业的技术人员应该了解，本发明不受上述实施例的限制，上述实施例和说明书中描述的仅为本发明的优选例，并不用来限制本发明，在不脱离本发明精神和范围的前提下，本发明还会有各种变化和改进，这些变化和改进都落入要求保护的本发明范围内。本发明要求保护范围由所附的权利要求书及其等效物界定。
Claims (1)
1.一种基于形状记忆材料的软组织扩张器，所述软组织扩张器在体外时具有厚度为一毫米的圆环型结构，所述软组织扩张器在植入前将其剪开并在热水中展开形成厚度为一毫米的长方形薄片，软组织扩张器的制备方法至少包括基于形状记忆环氧树脂材料的制备法和基于形状记忆丙烯酸酯材料的制备法，其特征在于：
所述基于形状记忆环氧树脂材料的制备法至少包括以下步骤：
A1.称取一定量的环氧树脂，在圆底烧瓶中加热至60℃融化；
B1.在步骤A1的基础上加入一定量的聚醚胺、甲基丙烯酸缩水甘油酯，磁力搅拌均匀；
C1.将此反应前驱液倒入软组织扩张器的模具中加热固化，首先在80℃的环境中反应4小时，之后在100℃的环境中反应2小时；D1.冷却至室温后从模具中取出，制备得到基于形状记忆环氧树脂材料的软组织扩张器；
所述基于形状记忆丙烯酸酯材料的制备法至少包括以下步骤：
A2.将3g丙烯酸异冰片酯、2g丙烯酸甲酯和0.1g 1,6-己二醇二丙烯酸酯混合均匀；
B2.在步骤A2的混合液中，加入0.01g光引发剂双苯基氧化膦，配制前驱液；
C2.将步骤B2中的反应前驱液倒入模具中，放置于紫外光环境中固化60秒，从模具中取出基于形状记忆丙烯酸酯材料的软组织扩张器。
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