CN110575607A - 一种药物球囊 - Google Patents
一种药物球囊 Download PDFInfo
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- CN110575607A CN110575607A CN201910946804.3A CN201910946804A CN110575607A CN 110575607 A CN110575607 A CN 110575607A CN 201910946804 A CN201910946804 A CN 201910946804A CN 110575607 A CN110575607 A CN 110575607A
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Classifications
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- A—HUMAN NECESSITIES
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/08—Materials for coatings
- A61L29/085—Macromolecular materials
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
- A61L29/16—Biologically active materials, e.g. therapeutic substances
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- A—HUMAN NECESSITIES
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- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/104—Balloon catheters used for angioplasty
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- A—HUMAN NECESSITIES
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Abstract
本发明公布了一种药物球囊，包括球囊和包覆在所述球囊表面的药物涂层；所述药物涂层包括纳米纤维网膜和药物颗粒，所述药物颗粒均匀涂覆到纳米纤维网膜内部和表面；所述药物涂层的厚度为5‑500μm。本发明的有益效果在于，首先，纳米纤维网膜比表面积大，通过静电作用力将药物吸附到纤维膜表面，对药物吸附能力得到根本性的改善，吸附药物的量得到极大的增加，同时在球囊输送及扩张过程中，能够尽可能的保持吸附在球囊外表面的药物；其次，纳米纤维网膜孔隙率高，可达70％以上，独特的多孔互连结构，使得药物可以位于纳米纤维网膜内，在球囊输送及扩张过程中，能够尽可能减少药物的损失。
Description
技术领域
本发明涉及医疗器械技术领域，尤其涉及一种药物球囊。
背景技术
药物涂层球囊是近年来出现的用于腔内狭窄治疗的新兴手段，它是将抗狭窄的药物涂置于球囊表面，当球囊到达病变并被撑开、扩张，与腔内内膜接触时，通过撕裂内膜并加压将药物快速释放、转移至局部内膜壁上的技术，通过药物的短期暴露达到较长时间治疗效果的目的。
目前贝朗医疗、美敦力、巴德、贝朗医疗、北京先瑞达和辽宁垠艺医疗等公司先后开发了药物涂层球囊，由于现有的球囊的表面结构使得球囊表面药物转载率较低，在球囊输送及扩张过程中，药物的损失达90％以上，渗透到血管的药物量将直接影响着治疗效果，药物涂层内所含有的药量越少，影响产品有效性，同时若脱落的微粒数量多，脱落的微粒很容易引起远端比较细小的腔体或管体闭塞、栓塞等并发症，严重者会导致截肢。血管及血流对药物球囊的影响的主要影响因素包括：血流对药物球囊涂层的冲刷，药物球囊在血管中的摩擦作用，这几个因素对应球囊的主要性质是涂层的牢固度。
静电纺丝纳米纤维由于具有比表面积大、孔隙率高、孔径分布窄及独特的多孔互连结构、易于操作及制作成本低，工艺过程相对简单，可重复性强等特点，使其在细微粒子捕捉方面优势十分显著。
发明内容
1.需要解决的技术问题
本发明需要结局的技术问题在于，提供一种能够更好的将药物涂到球囊外表面的药物球囊。当球囊到达病变位置后，在球囊扩张过程中，纳米纤维网膜与腔体内膜接触，表面和内部的药物“被挤压”到腔体内膜表面，使得腔体内膜表面均匀富集药物，利用细胞的快速吞噬，抑制细胞的增生，由此达到抑制再狭窄的功效。
2.技术方案
一种药物球囊，包括球囊和包覆在所述球囊表面的药物涂层；所述药物涂层包括纳米纤维网膜和药物颗粒，所述药物颗粒均匀涂覆到纳米纤维网膜内部和表面。
优选的是，所述药物涂层的厚度为5-500μm。
优选的是，所述纳米纤维网膜由纳米纤维单体通过静电纺丝方式制备，且所述纳米纤维网膜厚度为5-500μm；所述纳米纤维单体的直径为50-800nm、孔径为0.1-500μm。
优选的是，所述纳米纤维网膜的材料包括聚乳酸、尼龙、聚乳酸-羟基乙酸共聚物、聚丙烯酸、聚氨酯、纤维蛋白原、聚酰胺、聚丙交酯、聚乙交酯、醋酸纤维素、聚己内酯聚丁二酸丁二醇酯的一种或多种的混合。
优选的是，上述材料也包括聚乙烯基吡咯烷酮、聚乙烯亚胺、聚乙烯醚、甲基纤维素、聚乙烯醇、马来酸酐基共聚物、聚环氧乙烷、羟甲基纤维素、羟丙基纤维素、右旋糖酐、明胶、壳聚糖、羧甲基纤维素、胶原蛋白、蚕丝蛋白中一种或多种的混合。
优选的是，所述药物颗粒包括以下药物组份：用于治疗血管再狭窄的抗内膜增生药物、抗凝血药物、抗血小板粘附药物、抗感染药物、抗菌药物、消炎药物或抗肿瘤药物，可以包括并不限于雷帕霉素及其衍生物、地塞米松、紫杉醇、紫杉酚、类紫杉、多西他赛、普罗布考、秋水仙碱、肝素、华法林钠、维生素K拮抗剂、阿司匹林、前列腺素、丹酚酸、硝酸脂类药物、赖氨匹林、潘生丁、氨苄青霉素、头孢霉素、磺胺嘧啶、硫酸链霉素、壳聚糖及其衍生物、头孢西丁、萘啶酸、吡哌酸、柔红霉素、阿霉素、卡铂、大环内酯类中的一种或多种。
优选的是，上述药物颗粒还包括添加剂；所述添加剂包括聚乙二醇、弹性蛋白样聚合物、乙酸乙烯酯、聚氧化乙烯、壳聚糖、聚丙烯酸、聚谷氨酸、羧甲基纤维素(CMC)、透明质酸钠、藻酸钠、聚乙烯亚胺、聚烯丙胺、聚-N-乙酰葡糖胺、明胶、羧甲基纤维素钠、聚乙烯吡咯烷酮、聚山梨醇酯80、聚山梨醇酯20、纤维素酯、纤维素醚、尿素、碘普罗胺、硬脂酸、丙烯酸或甲基纤维、碘海醇一种或多种。
优选的是，所述药物组份与添加剂的质量比为0.1:10～10:0.1。
优选的是，所述药物的粒径为0.01～100μm。
3.有益效果
综上所述，本发明的有益效果在于：
(1)纳米纤维网膜比表面积大，通过静电作用力将药物吸附到纤维膜表面，对药物吸附能力得到根本性的改善，吸附药物的量得到极大的增加，同时在球囊输送及扩张过程中，能够尽可能的保持吸附在球囊外表面的药物；
(2)纳米纤维网膜孔隙率高，可达70％以上，独特的多孔互连结构，使得药物可以位于纳米纤维网膜内，在球囊输送及扩张过程中，能够尽可能减少药物的损失。
附图说明
图1纳米纤维网膜的平面示意图；
图2纳米纤维网膜的扫面电镜图；
图3纳米纤维网膜的立体示意图；
图中，1-纳米纤维网膜；2-药物颗粒。
具体实施方式
下面结合具体实施例对本发明做进一步说明，但本发明不受实施例的限制。
实施例：
将一定质量的Mn为75000的聚酰胺6(PA6)加入甲酸(FA)溶剂中配制质量分数为20％的PA6溶液，在室温下搅拌24h，获得完全溶解的PA6纺丝溶液，用平针头注射器从PA6溶液中吸取定量的溶液，固定在微量注射泵上开始纺丝，将施加电压设置为20kV，铝箔接收距离为12cm，温度为(25±2)℃，将PA6纤维沉积在铝箔上，纺丝30min停止，在40℃烘干4h，得到厚度约100um的PA6纳米纤维网膜1。截取9.4mm*20mm的长方形。取直径3.0mm长度20mm的球囊，将球囊充压至6atm，通过粘接方式将纳米纤维网膜1粘接与球囊表面平直部分。
将活性药物紫杉醇加入有机溶剂乙醇中，采用超声或加热方式使药物溶解，得
到活性药物溶液，所述药物溶液中活性药物溶液的浓度为10mg/mL。
通过浸涂方式，将药物溶液涂于上述球囊表面，40℃干燥2min，循环操作10次，40℃干燥4h后得将药物颗粒2包覆在球囊上，得到药物球囊。
虽然本发明已以较佳的实施例公开如上，但其并非用以限定本发明，任何熟悉此技术的人，在不脱离本发明的精神和范围内，都可以做各种改动和修饰，因此本发明的保护范围应该以权利要求书所界定的为准。
Claims (9)
1.一种药物球囊，其特征在于：包括球囊和包覆在所述球囊表面的药物涂层；所述药物涂层包括纳米纤维网膜和药物颗粒，所述药物颗粒均匀涂覆到纳米纤维网膜内部和表面。
2.根据权利要求1所述的一种药物球囊，其特征在于：所述药物涂层的厚度为5-500μm。
3.根据权利要求1所述的一种药物球囊，其特征在于：所述纳米纤维网膜由纳米纤维单体通过静电纺丝方式制备，且所述纳米纤维网膜厚度为5-500μm；所述纳米纤维单体的直径为50-800nm、孔径为0.1-500μm。
4.根据权利要求3所述的一种药物球囊，其特征在于：所述纳米纤维网膜的材料包括聚乳酸、尼龙、聚乳酸-羟基乙酸共聚物、聚丙烯酸、聚氨酯、纤维蛋白原、聚酰胺、聚丙交酯、聚乙交酯、醋酸纤维素、聚己内酯聚丁二酸丁二醇酯的一种或多种的混合。
5.根据权利要求4所述的一种药物球囊，其特征在于：上述材料也包括聚乙烯基吡咯烷酮、聚乙烯亚胺、聚乙烯醚、甲基纤维素、聚乙烯醇、马来酸酐基共聚物、聚环氧乙烷、羟甲基纤维素、羟丙基纤维素、右旋糖酐、明胶、壳聚糖、羧甲基纤维素、胶原蛋白、蚕丝蛋白中一种或多种的混合。
6.根据权利要求1所述的一种药物球囊，其特征在于：所述药物颗粒包括以下药物组份：用于治疗血管再狭窄的抗内膜增生药物、抗凝血药物、抗血小板粘附药物、抗感染药物、抗菌药物、消炎药物或抗肿瘤药物，可以包括并不限于雷帕霉素及其衍生物、地塞米松、紫杉醇、紫杉酚、类紫杉、多西他赛、普罗布考、秋水仙碱、肝素、华法林钠、维生素K拮抗剂、阿司匹林、前列腺素、丹酚酸、硝酸脂类药物、赖氨匹林、潘生丁、氨苄青霉素、头孢霉素、磺胺嘧啶、硫酸链霉素、壳聚糖及其衍生物、头孢西丁、萘啶酸、吡哌酸、柔红霉素、阿霉素、卡铂、大环内酯类中的一种或多种。
7.根据权利要求6所述的一种药物球囊，其特征在于：上述药物颗粒还包括添加剂；所述添加剂包括聚乙二醇、弹性蛋白样聚合物、乙酸乙烯酯、聚氧化乙烯、壳聚糖、聚丙烯酸、聚谷氨酸、羧甲基纤维素(CMC)、透明质酸钠、藻酸钠、聚乙烯亚胺、聚烯丙胺、聚-N-乙酰葡糖胺、明胶、羧甲基纤维素钠、聚乙烯吡咯烷酮、聚山梨醇酯80、聚山梨醇酯20、纤维素酯、纤维素醚、尿素、碘普罗胺、硬脂酸、丙烯酸或甲基纤维、碘海醇一种或多种。
8.根据权利要求7所述的一种药物球囊，其特征在于：所述药物组份与添加剂的质量比为0.1:10～10:0.1。
9.根据权利要求7所述的一种药物球囊，其特征在于：所述药物的粒径为0.01～100μm。
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