CN112137759A - 一种带涂层tips覆膜支架 - Google Patents
一种带涂层tips覆膜支架 Download PDFInfo
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Abstract
本发明专利涉及的是一种医疗器械，具体是一种带涂层的经颈静脉肝内门静脉穿刺支架（TIPS支架），由内表面覆膜、裸支架、外表面覆膜、中间分流装置组成，产品中间分流装置由多个瓣膜系统组成，瓣膜系统的瓣膜可根据门静脉的压力自动调整瓣膜的开口幅度，进而调节门静脉压力。产品中间分流装置中的多个瓣膜系统也可减少瓣膜背侧静止血液的区域，减少瓣膜背侧血栓的形成。产品裸支架涂覆派瑞林涂层可防止支架被血液腐蚀，杜绝支架金属离子进入人体危害患者健康。产品肝素涂层可防止支架植入部位的组织增生，防止支架内部的狭窄。
Description
技术领域
本发明专利涉及的是一种医疗器械，具体是一种带涂层的经颈静脉肝内门静脉穿刺支架（TIPS支架）。
背景技术
目前临床上在处理门静脉高压、门静脉高压引起的胃底出血的患者时，常采用经颈静脉肝内穿刺手术，在门静脉和肝静脉之间植入覆膜支架，建立一条新的血流通道来降低门静脉高压。进行该手术植入支架后，原本应流入肝脏的血液将通过新建立的通道不经肝脏代谢直接流入下腔静脉进行体循环，往往会造成一系列的并发症，如肝性脑病，肝衰竭、腹水等。为防止新建立的通道通过的血液过多，流入肝脏的血液过少，目前已设计出中间带瓣膜的支架，在门静脉压力高于24cmH2O时，瓣膜开口可以自动扩大，门静脉压力小于24cmH2O时，瓣膜开口可以恢复到正常大小。但此种设计在门静脉压力长时间小于24cmH2O时，由于瓣膜开口较小，容易在瓣膜和支架固定的部位，在面向血流的背侧造成血流静止，从而形成血栓，危害患者。再者该类支架一般由镍钛合金材料加工而成，该类材料长时间在体内容易被血液腐蚀，造成镍离子析出，进而造成镍离子中毒。
发明内容
为改善TIPS支架出现如上所述的镍离子析出、支架瓣膜背侧形成血栓的情况，本发明提供了一种带涂层的TIPS覆膜支架，该发明由内表面覆膜、裸支架、外表面覆膜、中间分流装置、显影结构组成，裸支架表面涂敷的涂层为派瑞林（Parylene，聚对二甲苯）涂层或其衍生物涂层，内表面覆膜或外表面覆膜的表面可涂敷肝素涂层。
上述外表面覆膜由ePTFE和FEP组成，内表面覆膜由ePTFE材料组成。
上述外表面覆膜加工成片状覆盖裸支架结构，外表面覆膜长度和内表面覆膜长度相等也可不相等。
上述外表面覆膜结构也可以加工成条状覆盖在裸支架外部。
外表面覆膜的长度小于裸支架的长度，外表面覆膜的长度和内表面覆膜长度相等。中间分流装置位于覆膜区段之间。
所述裸支架表面涂覆的涂层为派瑞林（Parylene，聚对二甲苯）涂层或其衍生物涂层也可不涂覆涂层，内表面覆膜或外表面覆膜的表面可涂覆肝素涂层，也可不涂覆肝素涂层。
所述派瑞林（Parylene，聚对二甲苯）涂层，涂层厚度为0.1-100微米，派瑞林活性分子的良好穿透力，涂层能涂敷到产品每个部位的表面，包括尖锐的棱边，裂缝里和内表面，能在产品内部、底部，周围形成无针孔，涂层可以抵御酸碱、盐雾及各种腐蚀性气件的侵害。派瑞林生物相溶性也好，可永久植入人体使用。
上述派瑞林分子结构可选用N型、C型、D型、HT型等一种或多种类型。
上述中间分流装置由生物膜或高分子材料膜组成，为网格状结构，每一个小网格为一个瓣膜系统。中间分流装置含有2个或2个以上瓣膜系统，每个瓣膜系统由多块瓣膜组合而成，瓣膜的数量为3-6块。瓣膜由瓣膜框和瓣膜片组成，瓣膜框由弹性金属丝如镍钛合金丝、不锈钢丝等组成，瓣膜片由生物膜或高分子材料膜组合而成。每一个瓣膜系统的瓣膜可合并组成一单向密合圆形状阀门。瓣膜系统可根据门静脉的压力自动调整各个瓣膜的闭合幅度，瓣膜开口方向与血流方向一致。当门静脉压力小于24cmH2O时，瓣膜可自动闭合，当门静脉压力大于24cmH2O时，瓣膜可自动打开。
上述裸支架结构由金属丝如镍钛丝、钴铬合金丝、不锈钢丝等经热处理加工成圆筒状结构。
上述裸支架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。
上述外表面覆膜结构和内表面覆膜结构经过热处理工艺与裸支架复合成一体。
本发明的有效益处是：根据门静脉压力大小，产品可自动调节瓣膜系统的开合幅度，防止门静脉压力升高。产品中间分流装置的多个瓣膜系统，可减少瓣膜背侧静止血液的区域，减少瓣膜背侧血栓的形成。产品经派瑞林涂层后形成一保护层，可防止金属材料加工成的支架被血液腐蚀，杜绝支架金属离子进入人体危害患者健康。产品覆膜经肝素涂层后可防止支架植入部位的组织增生，防止支架内部的狭窄。
附图说明
图1 为本发明左视图。
图2 为本发明正视图。
图3 为本发明中间分流装置瓣膜系统闭合时结构示意图。
图4为本发明中间分流装置瓣膜系统打开时结构示意图。
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、裸支架2、外表面覆膜3、中间分流装置4组成。裸支架2在内表面覆膜1和外表面覆膜3之间。中间分流装置4由2个或2个以上瓣膜系统5组成。
裸支架2的表面涂敷有派瑞林涂层，内表面覆膜1、外表面覆膜3的表面可涂敷有肝素涂层。
上述外表面覆膜3由ePTFE6和FEP 6组成，内表面覆膜1由ePTFE材料组成。
上述裸支架2由金属丝如镍钛丝、钴铬合金丝、不锈钢丝等经热处理加工成圆筒状结构。
上述外表面覆膜3结构和内表面覆膜1结构经过热处理工艺与裸支架2复合成一体。
如图2所示，外表面覆膜3的长度小于裸支架2的长度，外表面覆膜3的长度和内表面覆膜长度相等。裸支架2和外表面覆膜3重叠部分为产品覆膜区段8，中间分流装置4位于覆膜区段8之间。
如图3、图4所示，为本发明中间分流装置瓣膜系统闭合和打开结构示意图，瓣膜系统5由3-6块瓣膜51组成。瓣膜51由瓣膜片511和瓣膜框512组成。当门静脉压力小于24cmH2O时，每一个瓣膜系统5可自动闭合，并组成一单向闭合阀门，阻挡血流通过；当门静脉压力大于24cmH2O时，每一个瓣膜系统5可自动受压打开，释放血流通过，减小门静脉压力。
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 (8)
1.一种带涂层TIPS覆膜支架，由内表面覆膜、裸支架、外表面覆膜、中间分流装置组成，其特征在于裸支架表面涂覆有派瑞林涂层，内表面覆膜和外表面覆膜涂覆有肝素涂层，中间分流装置为网格状结构，每一个小网格为一个瓣膜系统，瓣膜系统由多块瓣膜组合而成。
2.根据权利要求1所述一种带涂层TIPS覆膜支架，其特征还在于中间分流装置含有2个或2个以上瓣膜系统，每个瓣膜系统由多块瓣膜组合而成，瓣膜的数量为3-6块。
3.根据权利要求2所述一种带涂层TIPS覆膜支架，其特征还在于瓣膜由瓣膜框和瓣膜片组成，瓣膜框由弹性金属丝如镍钛合金丝、不锈钢丝等组成，瓣膜片由生物膜或高分子材料膜组合而成。
4.根据权利要求2所述一种带涂层TIPS覆膜支架，其特征还在于每一个瓣膜系统的瓣膜可合并组成一单向密合圆形状阀门，瓣膜系统可根据门静脉的压力自动调整各个瓣膜的闭合幅度，瓣膜开口方向与血流方向一致，当门静脉压力小于24cmH2O时，瓣膜可自动闭合，当门静脉压力大于24cmH2O时，瓣膜可自动打开。
5.根据权利要求1所述一种带涂层TIPS覆膜支架，其特征还在于中间分流装置位于覆膜区段之间。
6.根据权利要求1所述一种带涂层TIPS覆膜支架，其特征还在于外表面覆膜3的长度小于裸支架2的长度，外表面覆膜3的长度和内表面覆膜长度相等。
7.根据权利要求1所述一种带涂层TIPS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。
8.根据权利要求1所述一种带涂层TIPS覆膜支架，其特征还在于裸支架表面可涂覆有派瑞林或其衍生物涂层也可不涂敷派瑞林或其衍生物涂层，内表面覆膜或外表面覆膜的表面可涂敷肝素涂层，也可不涂敷肝素涂层。
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