CN101784242A - 支架的药物释放膜和包括该药物释放膜并用于腔内扩张的药物释放支架 - Google Patents
支架的药物释放膜和包括该药物释放膜并用于腔内扩张的药物释放支架 Download PDFInfo
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Abstract
本发明涉及用于支架的药物释放膜和包括该药物释放膜、用于腔内扩张的药物释放支架。本发明的药物释放膜具有由内层M1和外层M2构成的双层结构,内层M是热固性树脂层,而所述外层M2是含有药物颗粒的热塑性树脂层。另外,根据本发明用于腔内扩张的药物释放支架具有这样的结构,在该结构中,所述药物释放膜***由形状记忆合金丝编织的圆柱形支架体S中。本方面即使在使用时接触到胆汁也具有良好的物理特性,并且由于药物仅在向着皮肤的一个方向释放,因而在药物治疗效果方面也是良好的。
Description
发明领域
本发明涉及药物释放膜和包括该药物释放膜、用于腔内扩张的药物释放支架,更具体地说,本发明涉及药物释放膜和包括该药物释放膜、用于腔内扩张的药物释放支架,因为,即使在使用时接触到胆汁等,其物理性能仍良好,并且仅在向着皮肤的一个方向平滑释放药物,所以它的药物治疗效果良好。
同时,最近,为了增强使用支架的治疗效果,已开发并且采用了具有药物释放功能的药物释放支架。
发明背景
通常,人体内发生的疾病导致人体内的腔狭窄,因此,功能降低,或者在严重情况下,功能可能丧失。例如,因为食管癌导致食管狭窄;因为动脉硬化,导致血液循环可能不平滑;或者胆汁从肝脏到血流的路径变窄。
在这些情况下,应当扩张变窄的腔,或者应当防止扩张的腔再次变窄。作为用于扩张变窄的通路并且使它保持这样的方法,有将所谓支架***腔内的方法。
通常,作为用于腔内扩张的支架,通常使用由形状记忆合金编织的圆柱形支架,以具有几个空间区域。
作为传统的药物释放支架,第0455343号韩国专利注册披露了药物释放支架,在其由金属丝形成的圆柱形主体上形成含有药物颗粒的聚氨基甲酸乙酯和聚乙二醇的涂层。
作为另一种传统药物释放支架,在其由金属丝形成的圆柱形主体上形成含有药物颗粒的聚氨基甲酸乙酯膜的药物释放支架也是公知的。
然而,如上所述的传统药物释放支架的问题在于,尽管药物释放良好,但是由于在使用期间,接触胆汁等,所以显著降低了诸如强度的物理特性,因为该涂层或者膜的主要成分是聚氨基甲酸乙酯树脂结构,在该结构中,硬段和软段交替排列。
作为传统药物释放支架的又一个例子,有一种药物释放支架也是公知的,在该药物释放支架上,***了在由金属丝形成的圆柱形主体上含有药物的硅树脂膜。由于这种传统药物释放支架由不溶性硅树脂构成,所以可以有效解决因为接触胆汁等而使物理特性降低的问题。但是,存在的问题是,因为硅树脂结构是固体,所以药物不能平滑释放,并且当硅树脂在高温硬化时,药物变性。
发明详述
(本发明要解决的问题)
本发明要解决上述问题,其目的是提供药物治疗效果良好的药物释放膜,因为即使在使用时它接触胆汁等,其物理特性仍良好,与此同时,药物仅在向着皮肤的方向平滑释放。
本发明的另一个目的是提供药物释放支架,在该药物释放支架中,药物释放膜***由金属丝编织的圆柱形支架体内。
(技术方案)
为了实现上述目的,提供了用于支架的药物释放膜,其具有包括内层M1和外层M2的双层结构,其中所述内层M1是热固性树脂层,而所述外层M2是含有药物颗粒的热塑性树脂层。
(有利效果)
即使在使用时接触胆汁,本发明仍具有良好的物理特性,并且因为药物仅在向着皮肤的一个方向平滑释放,所以其药物治疗效果也良好。
附图简要说明
在下面结合附图所做的详细描述中,更全面描述了本发明的优选实施方案的这些以及其他目的、特征、方面和优点。在附图中:
图1是根据本发明用于腔内扩张的药物释放支架的照片;
图2是示出根据本发明用于腔内扩张的药物释放支架的一实例的原理剖视图;
图3是示出根据本发明在从支架的药物释放膜M释放药物之前的横截面状态的照片;
图4是示出在释放药物之前,图3所示支架的药物释放膜M的外层M2的表面的照片;
图5是示出根据本发明从支架的药物释放膜M释放药物后横截面的状态的照片;
图6是示出在释放药物后图5所示支架的药物释放膜M的外层M2的表面的照片;以及
图7和图8是示出根据本发明,包括用于腔内扩张的药物释放支架的圆柱形支架体S结构的原理图。
附图中主要部分的符号说明:
S:圆柱形支架体 M:药物释放膜
M1:药物释放膜的内层
M2:药物释放膜的外层
A:内支架 B:外支架
C:固定丝 1:第一形状记忆合金丝
2:第二形状记忆合金丝
1a:直线部分 1b:尖峰部分
1c:谷底部分 1d:网孔部分(space portion)
最佳实施方式
下面将参考附图,详细描述本发明的优选实施方案。
首先,根据本发明用于支架的药物释放膜具有两层结构,它们是由内层M1和外层M2构成的,其特征在于内层M1是热固性树脂层,而外层M2是含有药物颗粒的热塑性树脂层。
具体地说,根据本发明用于支架的药物释放膜M是由作为热固性树脂层的内层M1和作为含有药物颗粒的热塑性树脂层的外层M2构成的双层结构。
图2是示出根据本发明的药物释放支架的原理剖视图,而图3和图5是分别示出药物释放膜M释放药物前、后的横截面状态的照片。
硅树脂等等可以用作内层M1的热固性树脂,而聚氨酯树脂等等可以用作外层M2的热塑性树脂。
如果在人体内进行手术,则内层M1粘附在圆柱形支架体S上,以便主要接触诸如由腔分泌的胆汁的分泌物,而外层M2直接接触皮肤表面。
如上所述,通过由作为不溶性树脂的硅树脂构成直接接触胆汁等的内层M1,本发明解决了,使用期间,物理特性降低的问题。
此外,根据本发明的在使用期间直接接触皮肤的外层M2由含有药物的聚氨酯树脂构成,因此,通过仅在向着皮肤的一个方向平滑释放药物,增强治疗效果。
外层M2还可以包括聚乙二醇和/或抗微生物剂。
药物颗粒是抗癌药物颗粒、生物免疫增强剂以及它们的混合物中的任何一种,并且在本发明中,药物颗粒的种类并不特别局限于此。
如果在内侧含有相对最小的药物颗粒,而在外侧含有相对最大的药物颗粒,以致随着所含药物从外层M2的内侧到外侧,所含药物的颗粒大小逐渐增大,则改善使用期间的药物释放效果越发有效。
同时,根据本发明的用于腔内扩张的药物释放支架包括:由形状记忆合金丝编织的圆柱形支架体S和***该圆柱形支架体S内的药物释放膜M。在这种用于腔内扩张的药物释放支架上,药物释放膜M是双层结构的,它由内层M1和外层M2构成,其特征在于,内层M1是热固性树脂,而其外层M2是含有药物颗粒的热塑性树脂。
换句话说,如图1所示,本发明的药物释放支架的特征在于,药物释放膜M是上述根据本发明的双层结构,它***圆柱形主体S内。
图1是根据本发明用于腔内扩张的药物释放支架的照片。
可以将图7和图8所示的支架体用作上述圆柱形支架体S。
图7和图8是示出这种圆柱形支架体S的结构的原理图。
作为实例,如图7所示,在圆柱形支架体S中,第一形状记忆合金丝1以多匝形成Z形,以形成多个直线部分1a和通过多个弯曲点接触所述直线部分1a的尖峰部分1b和谷底部分1c,任一匝的谷底部分和对应于与该一匝相邻匝的尖峰部分互相缠绕连接,以形成多个网孔部分1d。在对角线方向上,第二形状记忆合金丝2具有以给定间隔与第一形状记忆合金丝1缠绕的结构。
在本发明中,没有特别限定圆柱形支架体S的结构。
但是,为了通过减小圆柱形支架体S上的网孔部分的单元尺寸,来有效断绝进入腔内的癌细胞等,圆柱形支架体S构成还可以为由形状记忆合金丝1和2编织的圆柱形内支架A和外支架B和用于将这些支架固定为一体的固定丝C,以形成如图8所示的多个网孔部分1d。并且,外支架B以内支架A的网孔部分和外支架B的网孔部分互相交替的方式穿过内支架A,以使内支架的外表面和外支架的内表面互相紧密接触。这时,外支架和内支架的两端由固定丝C固定为一体。因此,优选使用这种结构的支架体。
此外,上述药物释放膜M优选安装在内支架A和外支架B之间。
下面,将参考附图详细描述根据本发明优选实施方案的人工血管支架的***装置。
但是,本发明并不局限于下面描述的实例。
实施例1
在将圆棒浸入硅树脂溶液后,以180℃对其进行硬化和干燥处理,以在该圆棒的表面上形成35μm厚的树脂涂层M1。
接着,将如上在表面上涂布了硅树脂的圆棒浸入含有14mg的OK4325Bial(药物)和5mg的金(Ag)颗粒的聚氨酯树脂溶液内,然后,使它干燥,以在形成于所述圆棒表面上的硅树脂涂层上形成50μm厚、还含有药物的聚氨酯树脂涂层M2。
接着,仅分离圆棒,以制备用于双层结构支架的药物释放膜M,在这种双层结构中,在硅树脂层M1上形成含有药物和金颗粒(抗微生物剂)的聚氨酯树脂,作为一体。
接着,将用于支架的药物释放膜M插在具有如图8所示结构的圆柱形支架体S的内支架A和外支架B之间,以制造用于腔内扩张的药物释放支架。
如图3示出药物释放之前用于支架的药物释放膜M的横截面照片,如图4示出药物释放之前用于支架的聚氨酯树脂层M2的表面的照片。
图5是示出药物释放3天后,支架的药物释放膜M的横截面的照片,而图6示出在释放药物后聚氨酯树脂层M表面的照片。
工业应用
本发明用于在食管因为食管癌变狭窄;血液因为动脉硬化不能平滑循环;或者胆汁从肝脏到血流的路径变窄的情况下,扩张狭窄的腔,或者防止扩张的腔再次变窄。
尽管结合附图所示的典型实施方案描述了本发明,但是它仅是说明性的。本技术领域内的技术人员应当明白,可以对本发明进行各种修改和等同变换。因此,应当由所附权利要求书限定本发明的实际技术范围。
Claims (12)
1.用于支架的药物释放膜,其具有包括内层M1和外层M2的双层结构,其中所述内层M1是热固性树脂层,而所述外层M2是含有药物颗粒的热塑性树脂层。
2.根据权利要求1所述的膜,其中所述药物颗粒选自抗癌颗粒、生物免疫增强剂颗粒以及它们的混合物中的任何一种。
3.根据权利要求1所述的膜,其中所述外层M2还包括抗微生物剂颗粒。
4.根据权利要求1所述的膜,其中所含药物颗粒的大小随着药物颗粒从所述外层M2的内侧到外侧而逐渐增大。
5.根据权利要求1所述的膜,其中所述热固性树脂是硅树脂。
6.根据权利要求1所述的膜,其中所述热塑性树脂是聚氨酯树脂。
7.用于腔内扩张的药物释放支架,具有由形状记忆合金丝编织的圆柱形支架体S和***所述圆柱形支架体S内的药物释放膜M,其中所述药物释放膜M的双层结构包括内层M1和外层M2,并且所述内层M1是热固性树脂层,而所述外层M2是含有药物颗粒的热塑性树脂层。
8.根据权利要求7所述的支架,其中所述圆柱形支架体S的构成为:圆柱形内支架A和外支架B,由形状记忆合金丝1和2编织的;和固定丝C,用于将这些支架固定为一体,以具有多个网孔部分1d,并且所述外支架B穿过所述内支架A,以便所述内支架的外表面和所述外支架的内表面互相紧密接触,以致所述内支架A的网孔部分和所述外支架的网孔部分互相交替,并且所述固定丝C将所述外支架和内支架的两端固定为一体。
9.据权利要求8所述的支架,其中药物释放膜M插在所述内支架A与所述外支架B之间。
10.根据权利要求7所述的支架,其中所述药物颗粒选自抗癌颗粒、生物免疫增强剂颗粒以及它们的混合物中的任何一种。
11.根据权利要求7所述的支架,其中所述外层M2还包括抗微生物剂颗粒。
12.根据权利要求7所述的支架,其中所含药物颗粒的大小随着其从外层M2的内侧到外侧而逐渐增大。
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KR10-2007-0083806 | 2007-08-21 | ||
PCT/KR2007/005389 WO2009025418A1 (en) | 2007-08-21 | 2007-10-30 | Drug releasing membrane for stent and drug releasing stent for expending intra luminal comprising the same |
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CN107485473A (zh) * | 2017-09-18 | 2017-12-19 | 郭启仓 | 一种下肢动脉硬化用血管撑开装置 |
CN110507449A (zh) * | 2018-05-22 | 2019-11-29 | 先健科技(深圳)有限公司 | 覆膜支架 |
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KR100847432B1 (ko) * | 2007-03-14 | 2008-07-21 | 주식회사 에스앤지바이오텍 | 내강 확장용 스텐트 |
US10076430B2 (en) * | 2015-10-19 | 2018-09-18 | Cook Medical Technologies Llc | Devce with tensioners |
KR101777194B1 (ko) | 2015-12-15 | 2017-09-11 | 전북대학교산학협력단 | 약물방출 및 열치료 기능을 갖는 스텐트와 이를 이용한 체외 전자기장 구동형 치료 시스템 |
KR101905687B1 (ko) * | 2017-01-17 | 2018-10-11 | 포항공과대학교 산학협력단 | 복수의 레이어 구조를 포함하는 스텐트 및 이의 제조방법 |
WO2021251712A1 (ko) * | 2020-06-12 | 2021-12-16 | 연세대학교 산학협력단 | 약물전달용 스텐트 및 이의 제조방법 |
KR102648316B1 (ko) * | 2020-06-12 | 2024-03-15 | 연세대학교 산학협력단 | 약물전달용 스텐트 및 이의 제조방법 |
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JP2660318B2 (ja) * | 1994-04-15 | 1997-10-08 | 株式会社エヌアンドエム | 胆道狭窄部の内瘻用アッセンブリ |
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KR100442330B1 (ko) | 2002-09-03 | 2004-07-30 | 주식회사 엠아이텍 | 스텐트 및 이 스텐트의 제조방법 |
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KR100511618B1 (ko) * | 2005-01-17 | 2005-08-31 | 이경범 | 약물방출 조절형 다층 코팅 스텐트 및 이의 제조방법 |
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CN107485473A (zh) * | 2017-09-18 | 2017-12-19 | 郭启仓 | 一种下肢动脉硬化用血管撑开装置 |
CN110507449A (zh) * | 2018-05-22 | 2019-11-29 | 先健科技(深圳)有限公司 | 覆膜支架 |
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