CN103610483A - 一种载药性的可降解的磁吻合器 - Google Patents
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Abstract
本发明提供一种载药性的可降解的磁吻合器,包括两个相同的结构单元,所述结构单元包括环状体以及若干个磁铁,环状体由内环和外环组成,所述磁铁沿环状体的圆周方向均匀排列于内环和外环之间,内环由可降解材料构成,外环由促进吻合口愈合的药物与可降解材料的混合物构成,本发明所述磁吻合器由分为内外两层的环状体和沿圆周排列的磁铁构成,由于内环采用可降解材料制成、外环采用可降解材料与促进愈合药物的混合物制成,因此,不仅可以在组织内腔吻合初期实现磁压力吻合,而且,随着内外环的分解,磁吻合器的体积逐渐缩小,可以顺利的排出体外,同时,外环分解过程中释放的药物渗出到吻合口周围,可以加速促进伤口愈合,减少感染风险,缩短吻合周期。
Description
技术领域
本发明涉及一种可生物降解的吻合结构,具体涉及一种可促进吻合口细胞再生的载药性的可降解的磁吻合器。
背景技术
对于严重的肝胆肠疾病常常需要进行胆囊、部分胃肠道、部分肝切除甚至肝移植等手术治疗。外科空腔脏器的吻合重建技术是手术实施过程中的一项基本操作。对吻合口重建的要求有:简单且手术时间短、浆膜对合良好、吻合口相关并发症少及吻合后吻合器易排出体外等。目前磁吻合器方面的研究取得很大的进展,但是其结构通常过于简单,主要包括两个磁性环,吻合后吻合器不易排出体外,同时,吻合过程中单纯依靠磁压力来使吻合口重建,压榨过程中吻合口修复是单纯依靠患者自身体内调节,吻合手术操作过程易感染,且吻合口重建时间长,磁铁压榨过程中的体内生物相容性差等,使其在临床上的应用受到了限制。
发明内容
为了克服目前磁吻合器存在的缺陷与不足,本发明的目的在于提供一种载药性的可降解的磁吻合器。
为达到上述目的,本发明采用了以下技术方案:
该磁吻合器包括两个相同的结构单元,所述结构单元包括环状体以及若干个磁铁,环状体由内环和外环组成,所述磁铁沿环状体的圆周方向均匀排列于内环和外环之间,内环由可降解材料构成,外环由促进吻合口愈合的药物与可降解材料的混合物构成。
所述可降解材料采用在肠道内腔3-10天降解的生物材料。
所述可降解材料为聚乳酸-羟基乙酸共聚物、纤维素、胶原-聚乙醇酸、羟基磷灰石-甲壳素或淀粉。
所述药物为促进伤口愈合的药物。
所述药物为生长因子、维生素C、维生素E或预防性抗生素中的一种或多种。
所述内环的外径尺寸为10-25mm,内环的内径尺寸为5-20mm;
外环的外径尺寸为15-30mm,外环的内径尺寸为10-25mm;内、外环厚度尺寸为3-20mm。
所述磁铁的材料选用钕铁硼、钐钴、铁氧体或铝镍钴。
所述内环的外圆周上开设有用于固定磁铁的凹槽。
所述磁铁为圆柱状,磁铁的直径≤(外环外径-内环内径)/2;磁铁的数量在2至最大磁铁数量之间,最大磁铁数量=[圆周率*(外环外径+内环内径)/2]/磁铁的直径。
所述外径、内径均指直径。
本发明的有益效果体现在:
本发明所述磁吻合器由分为内外两层的环状体和沿圆周排列的磁铁构成,由于内环采用可降解材料制成、外环采用可降解材料与促愈合药物的混合物制成,因此,不仅可以在组织内腔吻合初期实现磁压力吻合,而且,随着内外环的分解,磁吻合器的体积逐渐缩小,可以顺利的排出体外,同时,外环分解过程中释放的药物渗出到吻合口周围,可以加速促进伤口愈合,减少感染风险,缩短吻合周期。
附图说明
图1是本发明所述磁吻合器的结构示意图;
图2是基于本发明所述磁吻合器的吻合过程图,a为组织内腔吻合初期,b为吻合期,c为吻合后期;
图中:1为内环,2为磁铁,3为外环,4为肠道。
具体实施方式
下面结合附图和实施例对本发明作详细说明。
参见图1,本发明所述磁吻合器包括两个相同的结构单元,所述结构单元包括环状体以及若干个磁铁2,环状体由内环1和外环3组成,所述磁铁2沿环状体的圆周方向均匀排列于内环1和外环3之间,内环1由可降解材料构成,外环3由促进吻合口愈合的药物与可降解材料的混合物构成。
所述可降解材料采用在肠道内腔3-10天降解的生物材料。所述可降解材料可以为聚乳酸-羟基乙酸共聚物、纤维素、胶原-聚乙醇酸、羟基磷灰石-甲壳素或淀粉。所述药物为促进伤口愈合的药物。所述药物可以为生长因子、维生素C、维生素E或预防性抗生素中的一种或多种。
所述内环1的外径尺寸为10-25mm,内环1的内径尺寸为5-20mm;外环3的外径尺寸为15-30mm,外环3的内径尺寸为10-25mm;内、外环厚度尺寸为3-20mm。
所述磁铁的材料选用钕铁硼(牌号为N48、N52等)、钐钴、铁氧体或铝镍钴。所述内环1的外圆周上开设有用于固定磁铁2的凹槽。所述磁铁2为圆柱状,磁铁2的直径≤(外环外径-内环内径)/2;磁铁2的数量在2至最大磁铁数量之间,最大磁铁数量=[圆周率*(外环外径+内环内径)/2]/磁铁的直径。
使用时,磁铁2产生的磁力带动两个环状体造成磁压力吻合,参见图2a;内、外环逐渐降解,外环药物渗出到吻合口周围,促进伤口愈合,同时,内环也降解了一部分,内、外环体积均减小,参见图2b;内、外环降解完毕,磁铁因磁力抱合在一起,体积变小而排出体外,参见图2c。
实施例
一种载药物性的可降解磁压榨吻合器,涉及磁铁材料,可降解材料(如PLGA、纤维素(BC)、胶原-PGA及羟基磷灰石-甲壳素等)和促进吻合口治愈的药物(包括生长因子、维生素C、预防性抗生素等药物)等三种材料,该吻合器的结构单元是分内外两层的环状体,内环与外环之间放置若干个磁铁。
内环由可降解材料构成,主要作用是在吻合口重建前期支撑磁铁,为吻合口提供合适的压榨力,在吻合口重建后期,通过降解为磁铁排出节省空间。可降解材料根据性能要求可以采用具有一定的强度和较快的降解速度的生物材料。
外环是以可降解材料为载体与药物的混合物。在磁铁产生的磁力带动内外环造成磁压力吻合后,外环逐渐降解,药物渗出到吻合口周围,比如,促进细胞再生的生长因子及预防性的抗生素等药物逐渐释放,达到吻合口重建时的药物促进作用,促进伤口愈合。
在吻合后期,内环降解完毕,磁铁因磁力抱合在一起,体积变小而排出体外。
磁铁为钕铁硼磁柱,采用常规的镀氧化钛处理,饱和充磁后消毒。磁铁直径在3mm-10mm。
Claims (9)
1.一种载药性的可降解的磁吻合器,其特征在于:该磁吻合器包括两个相同的结构单元,所述结构单元包括环状体以及若干个磁铁(2),环状体由内环(1)和外环(3)组成,所述磁铁(2)沿环状体的圆周方向均匀排列于内环(1)和外环(3)之间,内环(1)由可降解材料构成,外环(3)由促进吻合口愈合的药物与可降解材料的混合物构成。
2.根据权利要求1所述一种载药性的可降解的磁吻合器,其特征在于:所述可降解材料采用在肠道内腔3-10天降解的生物材料。
3.根据权利要求1所述一种载药性的可降解的磁吻合器,其特征在于:所述可降解材料为聚乳酸-羟基乙酸共聚物、纤维素、胶原-聚乙醇酸、羟基磷灰石-甲壳素或淀粉。
4.根据权利要求1所述一种载药性的可降解的磁吻合器,其特征在于:所述药物为促进伤口愈合的药物。
5.根据权利要求1所述一种载药性的可降解的磁吻合器,其特征在于:所述药物为生长因子、维生素C、维生素E或预防性抗生素中的一种或多种。
6.根据权利要求1所述一种载药性的可降解的磁吻合器,其特征在于:所述内环(1)的外径尺寸为10-25mm,内环(1)的内径尺寸为5-20mm;外环(3)的外径尺寸为15-30mm,外环(3)的内径尺寸为10-25mm;内、外环厚度尺寸为3-20mm。
7.根据权利要求1所述一种载药性的可降解的磁吻合器,其特征在于:所述磁铁的材料选用钕铁硼、钐钴、铁氧体或铝镍钴。
8.根据权利要求1所述一种载药性的可降解的磁吻合器,其特征在于:所述内环(1)的外圆周上开设有用于固定磁铁(2)的凹槽。
9.根据权利要求1所述一种载药性的可降解的磁吻合器,其特征在于:所述磁铁(2)为圆柱状,磁铁(2)的直径≤(外环外径-内环内径)/2;磁铁(2)的数量在2至最大磁铁数量之间,最大磁铁数量=[圆周率*(外环外径+内环内径)/2]/磁铁的直径。
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