CN114099055A - 一种具有抗组织增生功能的疝气补片及其制备方法 - Google Patents
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Abstract
本发明专利属于医疗器械的技术领域,具体公开了一种具有抗组织增生功能的疝气补片,包括依次连接的基材层和载药层,所述基材层设置为采用由有机材料编织的带网孔结构,所述载药层由可降解聚合物负载抗组织增生药物通过涂层或静电纺丝方式制得;该补片采用成熟的编制工艺编织基材,并将抗组织增生药物负载于具有良好的生物安全性与相容性的PLGA或PCL可降解聚合材料上,在组织生长的过程中,载药层在降解过程中持续释放抗组织增生药物,解决了术后异物感严重的问题,提高了患者术后的舒适度。
Description
技术领域
本发明涉及医疗器械的技术领域,尤其是一种具有抗组织增生功能的疝气补片及其制备方法。
背景技术
疝气,即人体内某个脏器或组织离开其正常解剖位置,通过先天或后天形成的薄弱点、缺损或孔隙进入另一部位形成。疝气不可自愈,对患者日常生活造成了极大的影响,严重时甚至会危及生命。
由于有较高的发病率,疝气的治疗现已成为一个重要的社会问题,而疝修补术是治愈疝气唯一的选择。疝修补术是指通过手术治疗疝气,可以分为三大类:传统疝修补术、疝补片无张力修补术(或者称充填式修补术)和疝腹腔镜修补术。目前无张力疝气修补术已经成为临床医生治疗疝气所采取的常规术式,而疝气补片是其所必需的植入材料。当前市场上采用的疝气补片主要是聚丙烯网片以及其他含不可降解材料的补片,主要特征是在体内不能完全被降解吸收,植入的补片或补片的一部分永久留在体内,极易引起该部位的大量组织增生。这种增生通常为病理性增生,易造成术后有明显的异物感,长期的不适感,严重者具有慢性疼痛,术后需要二次手术取出。组织增生也可能对周围血管及神经造成压迫。此外,疝气补片植入部位通常与腹膜相邻,腹膜有很强的修复能力,损伤后可由结缔组织修复,如结缔组织增生过多,将引起粘连。
发明内容
针对现有技术中的问题,本发明提供一种抗组织增生功能的疝气补片。本发明提供的疝气补片制作工艺简单,植入人体后,能很好的解决术后异物感严重的问题,提高了患者术后的舒适度。
一种具有抗组织增生功能的疝气补片,包括依次连接的基材层和载药层,所述基材层设置为采用由有机材料编织的带网孔结构,所述载药层由可降解聚合物负载抗组织增生药物通过涂层或静电纺丝方式制得。
进一步,所述有机材料为聚乙烯、聚丙烯和聚酯中的任一种或多种。
进一步,所述基材层的厚度为0.1-1mm。
进一步,所述可降解聚合物为PLGA或PCL。
进一步,所述载药层所载药物为地塞米松、雷帕霉素、紫杉醇和非甾体抗炎药中的任一种或几种。
进一步,所述载药层的厚度为0.01-1mm。
进一步,所述抗组织增生疝气补片裁制成长方形、正方形、圆形和椭圆形中的任意一种。
进一步,所述的基材层的尺寸与载药层的尺寸一致。
上述具有抗组织增生功能疝气补片的制备方法如下:
1)将网片基材浸入醇类或酯类溶液中,超声清洗,烘干备用;
2)将PLGA或PCL与地塞米松、雷帕霉素、紫杉醇、非甾体抗炎药的一种或几种药物共混,溶解于氯仿或其他醇类溶剂中;
3)将网片基材浸入步骤1)制得的溶液中,待PLGA或PCL与药物负载在网片基材后取出材料,干燥,即得到抗组织增生疝气补片。
进一步,所述具有抗组织增生功能疝气补片还可由静电纺丝方式制得,具体步骤如下:
1)将网片基材浸入醇类或酯类溶液中,超声清洗,烘干备用;
2)将PLGA或PCL与抗组织增生药物地塞米松、雷帕霉素、紫杉醇、非甾体抗炎药的一种或几种药物共混,溶解于氯仿或其他醇类溶剂中,得到纺丝液;
3)将步骤2)制得的纺丝液加入静电纺丝设备中,进行静电纺丝,得到载药层;
4)将步骤1)备用的网片基材与步骤3)制得的载药层热压贴合,得到抗组织增生疝气补片。
与现有技术相比,本发明提供的一种具有抗组织增生功能的疝气补片结构与众不同,操作方便,该补片采用成熟的编制工艺编织基材,并将抗组织增生药物负载于具有良好的生物安全性与相容性的PLGA或PCL可降解聚合材料上,在组织生长的过程中,载药层在降解过程中持续释放抗组织增生药物,解决了术后异物感严重的问题,提高了患者术后的舒适度。
附图说明
为了更清楚地说明本发明实施例或现有技术中的技术方案,下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍,显而易见地,下面描述中的附图仅仅是本发明的一些实施例,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图获得其他的附图。
附图1为本发明的结构示意图。
图中:1为基材层,2为载药层。
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。
如图1所示,作为本发明一优选实施例的一种具有抗组织增生功能的疝气补片,包括依次连接的基材层1和载药层2,且基材层1和载药层2之间粘接,所述基材层1设置为采用由有机材料编织的带网孔结构,所述载药层2由可降解聚合物负载抗组织增生药物通过涂层或静电纺丝方式制得。
应用本发明提供的具有抗组织增生功能的疝气补片时,该补片采用成熟的编制工艺编织基材,并将抗组织增生药物负载于具有良好的生物安全性与相容性的PLGA或PCL可降解聚合材料上,在组织生长的过程中,载药层2在降解过程中持续释放抗组织增生药物,解决了术后异物感严重的问题,提高了患者术后的舒适度。
在上述实施例中,所述有机材料为聚乙烯、聚丙烯和聚酯中的任一种或多种。
具体地,所述基材层1的厚度可设置为0.1-1mm。
在上述实施例中,所述可降解聚合物为PLGA或PCL。
在上述实施例的基础之上,所述载药层2所载药物为地塞米松、雷帕霉素、紫杉醇和非甾体抗炎药中的任一种或几种。
在上述实施例的基础之上,所述载药层2的厚度为0.01-1mm。
针对所述补片的形状,所述抗组织增生疝气补片裁制成长方形、正方形、圆形和椭圆形中的任意一种。
优选地,所述的基材层1的尺寸与载药层2的尺寸一致,进而保持整齐。
实施例1
步骤一:取一个500ml干净的烧杯,加入300ml无水乙醇溶液,将网片基材1浸入无水乙醇溶液中,以40KHz超声清洗45min,放入干燥箱中烘干30min备用;
步骤二:用校准后的电子天平称量16g分子量为50000-500000的PLGA放入500ml干净烧杯中,加入30mg紫杉醇与其共混,溶解于400ml氯仿溶剂中;
步骤三:将步骤一备用的网片基材1浸入步骤二制得的溶液中,放入模具中,封口静置48h后取出材料,放入干燥箱干燥48h,即得到抗组织增生疝气补片。
实施例2
步骤一:取一个500ml干净的烧杯,加入300ml的甲醇溶液,将网片基材1浸入甲醇溶液中,以40KHz超声清洗30min,放入干燥箱中烘干45min备用;
步骤二:用校准后的电子天平称量12g分子量为40000-80000的PCL放入500ml的烧杯中,加入15mg紫杉醇与20mg雷帕霉素与其共混,溶解于400ml六氟异丙醇溶剂中;
步骤三:将步骤一备用的网片基材1浸入步骤二制得的溶液中,放入模具中,封口静置48h后取出材料,放入干燥箱干燥48h,即得到抗组织增生疝气补片。
实施例3
步骤一:取一个500ml干净的烧杯,加入300ml的无水乙醇溶液,将网片基材1浸入乙醇溶液中,以40KHz超声清洗45min,放入干燥箱中烘干30min备用;
步骤二:用校准后的电子天平称量16g分子量为40000-80000的PCL放入500ml的烧杯中,加入15mg的紫杉醇与20mg雷帕霉素与其共混,溶解于400ml六氟异丙醇溶剂中,得到400ml纺丝液;
步骤三:将步骤二制得的纺丝液加入静电纺丝设备中,设置纺丝参数,纺丝,其中纺丝电压为12kV,接收距离12-18cm,进样速度为0.8-10ml/h,最后在真空干燥箱中除去残留的溶剂,即得到载药层2;
步骤四:将步骤一备用的网片基材1与步骤三制得的载药层2热压贴合,得到抗组织增生疝气补片。
本发明提供的一种抗组织增生疝气补片的工艺简单,操作可行,适合大规模生产,载药层2在组织生长的过程中持续释放抗组织增生药物,可以有效地抑制组织增生。
以上所述仅是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明原理的前提下,还可以做出若干改进和润饰,这些改进和润饰也应视为本发明的保护范围。
Claims (10)
1.一种具有抗组织增生功能的疝气补片,其特征在于,包括依次连接的基材层和载药层,所述基材层设置为采用由有机材料编织的带网孔结构,所述载药层由可降解聚合物负载抗组织增生药物通过涂层或静电纺丝方式制得。
2.根据权利要求1所述的具有抗组织增生功能的疝气补片,其特征在于,所述有机材料为聚乙烯、聚丙烯和聚酯中的任一种或多种。
3.根据权利要求1所述的具有抗组织增生功能的疝气补片,其特征在于,所述基材层的厚度为0.1-1mm。
4.根据权利要求1所述的具有抗组织增生功能的疝气补片,其特征在于,所述可降解聚合物为PLGA或PCL。
5.根据权利要求1所述的具有抗组织增生功能的疝气补片,其特征在于,所述载药层所载药物为地塞米松、雷帕霉素、紫杉醇和非甾体抗炎药中的任一种或几种。
6.根据权利要求1所述的具有抗组织增生功能的疝气补片,其特征在于,所述载药层的厚度为0.01-1mm。
7.根据权利要求1所述的具有抗组织增生功能的疝气补片,其特征在于,所述抗组织增生疝气补片裁制成长方形、正方形、圆形和椭圆形中的任意一种。
8.根据权利要求1所述的具有抗组织增生功能的疝气补片,其特征在于,所述的基材层的尺寸与载药层的尺寸一致。
9.一种具有抗组织增生功能的疝气补片的制备方法,其特征在于,包括如下步骤:
1)将网片基材浸入醇类或酯类溶液中,超声清洗,烘干备用;
2)将PLGA或PCL与地塞米松、雷帕霉素、紫杉醇、非甾体抗炎药的一种或几种药物共混,溶解于氯仿或其他醇类溶剂中;
3)将网片基材浸入步骤1)制得的溶液中,待PLGA或PCL与药物负载在网片基材后取出材料,干燥,即得到抗组织增生疝气补片。
10.根据权利要求9所述的具有抗组织增生功能的疝气补片的制备方法,其特征在于,还可由静电纺丝方式制得,包括如下步骤:
1)将网片基材浸入醇类或酯类溶液中,超声清洗,烘干备用;
2)将PLGA或PCL与抗组织增生药物地塞米松、雷帕霉素、紫杉醇、非甾体抗炎药的一种或几种药物共混,溶解于氯仿或其他醇类溶剂中,得到纺丝液;
3)将步骤2)制得的纺丝液加入静电纺丝设备中,进行静电纺丝,得到载药层;
4)将步骤1)备用的网片基材与步骤3)制得的载药层热压贴合,得到抗组织增生疝气补片。
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