CN112137758A - 一种双层药物涂层血管覆膜支架 - Google Patents
一种双层药物涂层血管覆膜支架 Download PDFInfo
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Abstract
本发明涉及的是外周血管领域的一种双层药物涂层血管覆膜支架,本发明由内表面覆膜、金属支架、外表面覆膜、显影结构组成,支架头端呈花瓣状结构。外表面覆膜由ePTFE和FEP组成,内表面覆膜由ePTFE材料组成,内表面覆膜涂敷有肝素涂层,外表面覆膜涂敷有紫杉醇或雷帕霉素涂层。产品表面的肝素、紫杉醇或雷帕霉素涂层,可以防止产品接触部位的血栓形成,防止血管内膜的增生以及再狭窄。
Description
技术领域
本发明专利涉及的是一种医疗器械,具体是一种外周血管领域的血管支架。
背景技术
目前临床上在处理血管疾病如血管瘤、血管穿孔时,血管腔内修复术为患者提供了大量的临床获益,并已被证明是安全和有效的方法--这种微创的方法通过放置血管腔内支架成为标准开放手术修补的替代治疗,缩短了在监护病房的时间和住院时间,更快的恢复正常活动,具有较低发病率、患者恢复快等优点。随着血管腔内血管覆膜支架的使用,临床上的不良事件也经常被报道,如血管血栓形成、阻塞、边缘性狭窄等,造成患者再次住院进行治疗。
发明内容
为改善血管覆膜支架出现的如上述血管增生再狭窄弊端,本发明提供了一种双层药物涂层的血管覆膜支架,该发明由内表面覆膜、金属支架、外表面覆膜、显影结构组成,支架头端呈花瓣状结构,内表面覆膜涂敷有肝素涂层,外表面覆膜涂敷有紫杉醇或雷帕霉素涂层。
上述外表面覆膜由ePTFE和FEP或由其中一种材料组成,内表面覆膜由ePTFE材料组成。
上述外表面覆膜长度和内表面覆膜长度可相等也可不相等。外表面覆膜、内表秒覆膜的长度和金属支架的长度可相等也可以不相等。
上述外表面覆膜结构可以加工成片状,也可以加工成条状覆盖在金属支架表面。
上述内表面覆膜涂敷为肝素涂层,外表面覆膜涂敷为紫杉醇或雷帕霉素涂层或者紫杉醇和雷帕霉素的混合涂层。
上述内表面覆膜涂敷还可为肝素和紫杉醇混合涂层或者肝素和雷帕霉素混合涂层,外表面覆膜涂敷为紫杉醇涂层或无涂层。
上述覆膜支架一端或两端加工成花瓣状结构。
上述金属支架可以由金属丝如镍钛丝、不锈钢丝或其合金丝等经热处理加工成圆筒状结构。圆筒状结构由单条加工成S形结构的金属丝顺时针或逆时针编织而成,每个相邻的两排编织丝之间无额外连接结构。
上述金属支架的圆筒状结构也可以由镍钛管、钴铬合金管、不锈钢管或其改性合金等经激光切割并扩张而成。圆筒状结构由加工成S形结构的金属杆顺时针或逆时针环绕而成,每个相邻的两排金属丝之间有或者没有额外连接结构。
上述金属支架一端加工有不透射线的显影结构或两端均加工有不透射线的显影结构,显影材料由金、铂、锇、铼、钨、铱、铑、钽中的一种和几种合金材料组成。
上述外表面覆膜结构和内表面覆膜结构经过热处理工艺或粘结工艺与金属支架复合成一体。
本发明的有效益处是:本发明的内表面覆膜和外表面覆膜涂敷有肝素、紫杉醇、雷帕霉素成分,肝素具有抗凝血作用,紫杉醇和雷帕霉素均具有抗组织增生作用,可以抑制血管平滑肌细胞的增殖以及血管内膜的增生,可以减少血栓的形成,降低冠状动脉再狭窄的发生率,降低支架内再狭窄。通过对产品表面进行上述成分涂层,可以防止产品接触部位的血栓形成,防止血管内膜增生以及再狭窄。
附图说明
图1 为本发明局部剖视结构示意图。
图2 为图1横切面结构示意图。
图3 为本发明另一实施例结构示意图。
具体实施方式
下面根据说明书附图对本发明作进一步说明:
如图1所示,本发明由内表面覆膜1、金属支架2、外表面覆膜3、显影结构4组成,两头端加工成花瓣状结构7。金属支架2由多排S形结构的金属丝5编织成圆筒状结构。金属支架2位于内表面覆膜1和外表面覆膜3之间,显影结构4加工在金属支架2的头端。
上述外表面覆膜3由ePTFE和FEP组成,内表面覆膜由ePTFE材料组成。
如图1所示,外表面覆膜3完全覆盖金属支架2,外表面覆膜3的长度和内表面覆膜1的长度相等。
内表面覆膜1涂敷为肝素涂层10,外表面覆膜3涂敷为紫杉醇或雷帕霉素涂层或者紫杉醇和雷帕霉素的混合涂层11。
上述金属支架2圆筒状结构由单条加工成S形结构的金属丝顺时针编织而成,每个相邻的两排编织丝5之间无额外连接结构。
上述金属支架2两端均加工有不透射线的显影结构4,显影材料由金、铂、锇、铼、钨、铱、铑、钽中的一种和几种合金材料组成。
上述外表面覆膜3和内表面覆膜1经过热处理工艺与金属支架2复合成一体。
如图2所示,外表面覆膜3由材料ePTFE 8和材料FEP 9两种材料组成,金属支架2位于内表面覆膜1和外表面覆膜3之间。
如图3所示,为本发明另一实施例,由内表面覆膜1、金属支架2、外表面覆膜6、显影结构4组成,两头端加工成花瓣状结构7。金属支架2在内表面覆膜1和外表面覆膜6之间,显影结构4加工在金属支架2的头端。
如图3所示,外表面覆膜6加工成条状,覆盖在金属支架2的每排编织丝上。其他结构与图1一致。
以上所述,仅为本发明的典型实例,不用于限制本发明,凡在本发明的基础上改进和扩展的实例均在本发明的保护范围之内。
Claims (10)
1.一种双层药物涂层血管覆膜支架,由内表面覆膜、金属支架、外表面覆膜、显影结构组成,其特征是头端加工成花瓣状结构,内表面覆膜涂敷为肝素涂层,外表面覆膜涂敷为紫杉醇或雷帕霉素涂层或者紫杉醇和雷帕霉素的混合涂层。
2.根据权利要求1所述一种双层药物涂层血管覆膜支架,其特征还在于外表面覆膜加工成片状结构完全覆盖金属支架结构,外表面覆膜长度和内表面覆膜长度相等。
3.根据权利要求1所述一种双层药物涂层血管覆膜支架,其特征还在于外表面覆膜由ePTFE和FEP组成,内表面覆膜由ePTFE材料组成。
4.根据权利要求1所述一种双层药物涂层血管覆膜支架,其特征还在于金属支架结构由金属丝如镍钛丝、钴铬合金丝、不锈钢丝等加工成圆筒状结构,圆筒状结构由单条加工成S形结构的金属丝顺时针或逆时针编织而成,每个相邻的两排编织丝之间无额外连接结构。
5.根据权利要求1所述一种双层药物涂层血管覆膜支架,其特征还在金属支架的圆筒状结构也可以由镍钛管、钴铬合金管、不锈钢管或其改性合金等经激光切割并扩张而成,圆筒状结构由加工成S形结构的金属杆顺时针或逆时针环绕而成,每个相邻的两排金属丝之间有或者没有额外连接结构。
6.根据权利要求2所述一种双层药物涂层血管覆膜支架,其特征还在于外表面覆膜结构加工成条状结构覆盖在金属支架的每排编织丝上。
7.根据权利要求1所述一种双层药物涂层血管覆膜支架,其特征还在于金属支架一端加工有不透射线的显影结构或两端均加工有不透射线的显影结构。
8.根据权利要求7所述一种双层药物涂层血管覆膜支架,其特征还在于显影材料由金、铂、锇、铼、钨、铱、铑、钽中的一种和几种合金材料组成。
9.根据权利要求1所述一种双层药物涂层血管覆膜支架,其特征还在于派瑞林或其衍生物涂层厚度为0.1-100微米。
10.根据权利要求1所述一种双层药物涂层血管覆膜支架,其特征还在于内表面覆膜涂层为肝素和紫杉醇混合涂层或者肝素和雷帕霉素混合涂层,外表面覆膜涂敷为紫杉醇涂层或无涂层。
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