CN115252247A - 一种带有创口补丁的可降解支架系统 - Google Patents
一种带有创口补丁的可降解支架系统 Download PDFInfo
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Abstract
本发明公开了一种带有创口补丁的可降解支架系统，涉及医疗器械技术领域，包括球囊本体和输送导管，输送导管贯穿球囊本体，输送导管包括连接球囊本体的外管和位于球囊本体及外管内部的内管，球囊本体和内管上设置有至少一个用于影像学检查定位的显影结构，球囊本体外部设置有支架，支架为表面镂空的内部中空管状结构，位于支架表面镂空处连接有至少一个可降解创口补丁，可降解创口补丁与显影结构对应设置，支架和补丁均可降解，植入病变部位后，提供径向支撑力用于促进血运重建，补丁封堵由球囊预处理或支架网络结构扩张时造成的血管撕裂创口，补丁和支架的设计，避免支架的镂空处被覆膜全覆盖，避免微小侧枝血管的封堵。
Description
技术领域
本发明涉及医疗器械技术领域，具体涉及一种带有创口补丁的可降解支架系统。
背景技术
现有技术是使用血管介入治疗，通过在皮肤和血管上开通微小的通道，在影像设备的辅助引导下进行的微创治疗。治疗位置不限于冠状动脉及外周动脉包括上肢动脉、下肢动脉等。主要治疗方式有基于球囊扩张导管的经皮腔内血管成形术，血管支架和沿导丝的路径推至病变部位的自扩式血管覆膜支架等。
经皮腔内血管成形术使用的球囊导管一般采用壁厚相同且平滑的球囊结构，沿导丝进入血管到病变部位，通过加压扩张，球囊主体部位呈圆柱体扩张，各位置压强相等，支架容易从球囊上脱落，通过加压对病变位置施力，使管腔扩大或钙状硬化部位被压碎，然后泄压退出，起到增大病变部位血流畅通率的作用。
现阶段使用的主流支架产品由金属材料制成，使用压握技术将支架嵌入球囊主体，经球囊导管输送到病变位置，通过加压，球囊扩张可将支架也进行扩张。支架被扩开后并保持被扩张的形状，基于对血管的径向作用力，留在病变部位可以对血管提供良好的支撑力，使血管直径增大，血流通畅。还有近年出现的生物可降解支架，使用同样的介入植入技术将支架运送至靶病变部位，实现短期的径向支撑，待血运重建结束后，逐渐在体内降解，被人体吸收。
用于封堵作用的覆膜支架，在冠脉及外周血管出现穿孔、夹层或动脉瘤等管腔内有破损的情况时，使用管径较细的输送系统将压缩的覆膜支架运送到病变位置后准确释放，覆膜支架覆盖在病变的动脉及分支上，形成新的血流通道，有效地封堵治疗。
现有技术中，球囊扩张时，病变部位的血管被扩张支撑起来呈现笔直管体，而非血管本身的带有弧度且呈微锥体的形态。在球囊保压过程中，病变位置容易在球囊的扩张压力下受到损伤，病变部位有很大概率被撕开，撕裂的伤口较小时可不做处理，伤口较大时在血流的冲刷作用下，会持续增大。出现管腔内创口，会给手术成功率造成不利影响，有可能需要二次手术，术后也有潜在的血管夹层或血管瘤形成的隐患。
在临床上，在动脉内置入大的覆膜支架的过程中，可能会出现锚定区不足覆盖管腔内缺口位置或由于操作不慎误堵重要分支的情况，还可能出现覆膜支架的形状与靶病变动脉的内腔不完全吻合，覆膜支架与动脉、分支和内腔之间出现一定缝隙，导致经此处的血液在缝隙中涡流，影响血液流动。因此，本领域技术人员提供了一种带有创口补丁的可降解支架系统，以解决上述背景技术中提出的问题。
发明内容
为解决上述技术问题，本发明提供一种带有创口补丁的可降解支架系统，包括输送系统，所述输送系统包括球囊本体和输送导管，输送导管贯穿球囊本体，输送导管包括连接球囊本体的外管和位于球囊本体及外管内部的内管，球囊本体外部设置有支架，支架为表面镂空的内部中空管状结构，
所述球囊本体和所述内管上均设置有至少一个用于影像学检查定位的显影结构；
位于所述支架表面镂空处连接有至少一个补丁，补丁与用于影像学检查定位的显影结构对应设置。
优选的：所述支架为可降解材料制成。
优选的：所述球囊本体包括外层球囊和内层球囊。
优选的：所述外层球囊为具有弹性的顺应性球囊，外层球囊外壁对应支架的镂空处设置有形状相对应的凸起部。
优选的：所述外层球囊上用于影像学检查定位的显影结构为显影性涂层，显影性涂层涂在凸起部的内壁。
优选的：所述内层球囊为非顺应性球囊，内层球囊的尺寸对应病变血管的尺寸。
优选的：所述内管上用于影像学检查定位的显影结构为显影环。
优选的：所述显影环与显影性涂层对应设置，显影环镶嵌在内管上，用于术中跟踪支架位置和补丁位置。
优选的：所述补丁包括外层药物涂层、中层贴片和内层药物涂层，优选的，所述外层药物涂层包含促进愈合类因子，如生长因子，优选的，所述中层贴片为高弹性可降解薄膜，优选的，所述内层药物涂层包含抗血栓类药物，抗血栓药物如肝素、雷帕霉素。
优选的：所述补丁为纳米纤维网，在纳米纤维网的两侧带涂有可预防血栓形成的药物，如肝素、雷帕霉素和促进愈合类因子，如生长因子涂层。
本发明的技术效果和优点：
1、本发明中，支架和补丁均可降解，植入病变部位后，提供径向支撑力用于促进血运重建，补丁封堵由球囊预处理或支架网络结构扩张时造成的血管撕裂创口，补丁和支架的设计，避免支架的镂空处被覆膜全覆盖，避免微小侧枝血管的封堵。
2、本发明中，球囊本体双层设计，在外球囊的凸起部内壁涂有显影性涂层，一方面可减少支架在植入过程中滑脱的风险，另一方面在影像学检查下确定补丁的位置，通过手术者操作输送导管深入量或以影像中血管分支位置准确将补丁贴到创口位置。
3、本发明中，输送导管的内管上镶嵌有显影环，对应补丁位置，进一步增强补丁的位置可追踪性。
附图说明
图1是本申请实施例提供的带有创口补丁的可降解支架系统结构示意图；
图2是本申请实施例中支架的结构示意图；
图3是本申请实施例中球囊本体的剖视图；
图4是图3中B处的结构放大示意图；
图5是本申请实施例中外层球囊的部分的结构示意图；
图6是图1中A处的结构放大图中补丁的结构示意图；
图7是本申请实施例1中补丁的结构示意图；
图8是本申请实施例2中补丁的结构示意图；
图9是本申请实施例3中补丁的结构示意图；
图10是本申请实施例4中补丁的结构示意图；
图11是本申请实施例5中补丁的结构示意图。
图中：1、球囊本体；101、外层球囊；102、内层球囊；103、凸起部；2、输送导管；3、支架；4、补丁；401、外层药物涂层；402、中层贴片；403、内层药物涂层；5、显影环；6、显影性涂层。
具体实施方式
下面结合附图和具体实施方式对本发明作进一步详细的说明。本发明的实施例是为了示例和描述起见而给出的，而并不是无遗漏的或者将本发明限于所公开的形式。很多修改和变化对于本领域的普通技术人员而言是显而易见的。选择和描述实施例是为了更好说明本发明的原理和实际应用，并且使本领域的普通技术人员能够理解本发明从而设计适于特定用途的带有各种修改的各种实施例。
请参阅图1～2，在本实施例中提供一种带有创口补丁的可降解支架系统，包括球囊本体1和输送导管2，输送导管2贯穿球囊本体1，输送导管2包括连接球囊本体1的外管和位于球囊本体1及外管内部的内管，球囊本体1和内管上均设置有至少一个用于影像学检查定位的显影结构，球囊本体1外部设置有支架3，支架3为表面镂空的内部中空管状结构，支架3为可降解材料制成，位于支架3表面镂空处连接有至少一个补丁4，补丁4与用于影像学检查定位的显影结构对应设置，使用输送导管2和球囊本体1将带有补丁4的支架3运送至病变部位，根据血管造影及OCT检查管腔内壁，在影像学检查下可确定显影结构位置，可确定支架3和补丁4位置，根据OCT可确定病变血管长度，参考输送导管2伸入量可确定血管创口位置，进而将补丁4运送至病变部位，球囊本体1加压扩张，支架3形变贴于血管内壁，补丁4封堵因球囊预处理造成的管腔内创口以及支架3可能会撕裂的内壁，支架3安装后，撤出球囊本体1和输送导管2，支架3提供径向支撑力支撑血运重建，补丁4封堵血管内创口，避免血流冲刷创口造成夹层产生。
请参阅图3～5，球囊本体1包括外层球囊101和内层球囊102，外层球囊101为具有弹性的顺应性球囊，外层球囊101外壁对应支架3的镂空处设置有形状相对应的凸起部103，支架3套在外层球囊101上，凸起部103嵌入支架3的镂空处，减少支架3在植入过程中脱落的风险，外层球囊101上用于影像学检查定位的显影结构为显影性涂层6，显影性涂层6涂在凸起部103的内壁，在影像学检查下确定显影性涂层的位置，可确定补丁4的位置，通过手术者操作输送导管2伸入量或以影像中血管分支位置准确将补丁4贴到创口位置，内层球囊102为非顺应性球囊，内层球囊102的尺寸对应病变血管的尺寸，内层球囊102起到扩张支架3的作用，输送导管2的内管上用于影像学检查定位的显影结构为显影环5，显影环5与显影性涂层6对应设置，显影环5镶嵌在内管上，用于术中跟踪支架3位置和补丁4位置。
请参阅图6，补丁4包括外层药物涂层401、中层贴片402和内层药物涂层403，其中，外层药物涂层401贴近血管壁，外层药物涂层401包含促进愈合类因子，如生长因子，中层贴片402为高弹性可降解薄膜，内层药物涂层403包含抗血栓类药物，抗血栓药物如肝素、雷帕霉素，能降低血小板沉积和血栓形成。
实施例1
本实施例中，多个补丁4呈环状设置在支架3的中部的镂空处。
实施例2
本实施例中，多个补丁4呈环状按相同间隔设置在支架3的镂空处。
实施例3
本实施例中，多个补丁4呈环状设置在支架3两端的镂空处。
实施例4
本实施例中，多个补丁4呈环状设置在支架3前端的镂空处。
实施例5
本实施例中，多个补丁4呈环状设置在支架3后端的镂空处。
实施例6
本实施例中，在影像学检查中，预先在病变血管段前后内壁180°对称的位置内置可分辨方向的显影性部件，进行OCT影像学检查时，可根据这两个显影部件确定创口的准确位置，然后使用1:1的转动的球囊输送系统，旋转输送导管，补丁4准确地封堵创口位置，减少在制作过程中补丁4的数量。
实施例7
本实施例中，补丁4是经静电纺丝制出的类ECM(extracellularmatrix)的纳米纤维网，有利于内皮细胞爬附，在纳米纤维网的两侧带涂有可预防血栓形成的药物，如肝素、雷帕霉素和促进愈合类因子，如生长因子涂层。
本发明的工作原理是：
使用时，通过OCT影像学检查，以影像中血管分支位置为参照点或导管深入量确定血管内病变位置和血管内创口位置；
支架3嵌套在外层球囊101的凸起部103处，防止支架3在植入扩张过程中滑落，并且根据凸起部103处的显影性涂层6能确定补丁4的位置，内层球囊102起到扩张支架3的作用，穿刺建立通路后，将支架3通过球囊本体1和输送导管2运送至病变部位，对外层球囊101加压，在影像检测中可确定支架3和补丁4的位置以及进行位置微调，内层球囊102在充压后，将支架3和补丁4一起紧贴在管腔内壁，支架3起到径向支撑的作用，补丁4贴合封堵血管内壁的创口；
补丁4中外层药物涂层401具有促进创口愈合的生长因子，内层药物涂层403能降低血小板沉积和血栓形成；
多个型号的补丁4和支架3中，补丁4对应的凸起部103内壁涂有显影性涂层6，对应的内管镶嵌显影环5，用于术中根据支架3位子和补丁4位置；
完成植入后，泄压撤出球囊本体1和输送导管2，再次进行影像学检查。
显然，所描述的实施例仅仅是本发明的一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域及相关领域的普通技术人员在没有作出创造性劳动的前提下所获得的所有其他实施例，都应属于本发明保护的范围。本发明中未具体描述和解释说明的结构、装置以及操作方法，如无特别说明和限定，均按照本领域的常规手段进行实施。
Claims (10)
1.一种带有创口补丁的可降解支架系统，包括输送系统，所述输送系统包括球囊本体(1)和输送导管(2)，输送导管(2)贯穿球囊本体(1)，输送导管(2)包括连接球囊本体(1)的外管和位于球囊本体(1)及外管内部的内管，球囊本体(1)外部设置有支架(3)，支架(3)为表面镂空的内部中空管状结构，其特征在于：
所述球囊本体(1)和所述内管上均设置有至少一个用于影像学检查定位的显影结构；
位于所述支架(3)表面镂空处连接有至少一个补丁(4)，补丁(4)与用于影像学检查定位的显影结构对应设置。
2.根据权利要求1所述的一种带有创口补丁的可降解支架系统，其特征在于，所述球囊本体(1)包括外层球囊(101)和内层球囊(102)。
3.根据权利要求3所述的一种带有创口补丁的可降解支架系统，其特征在于，所述外层球囊(101)为具有弹性的顺应性球囊，外层球囊(101)外壁对应支架(3)的镂空处设置有形状相对应的凸起部(103)。
4.根据权利要求4所述的一种带有创口补丁的可降解支架系统，其特征在于，所述外层球囊(101)上用于影像学检查定位的显影结构为显影性涂层(6)，显影性涂层(6)涂在凸起部(103)的内壁。
5.根据权利要求3所述的一种带有创口补丁的可降解支架系统，其特征在于，所述内层球囊(102)为非顺应性球囊，内层球囊(102)的尺寸对应病变血管的尺寸。
6.根据权利要求1所述的一种带有创口补丁的可降解支架系统，其特征在于，所述内管上用于影像学检查定位的显影结构为显影环(5)。
7.根据权利要求6所述的一种带有创口补丁的可降解支架系统，其特征在于，所述显影环(5)与显影性涂层(6)对应设置，显影环(5)镶嵌在内管上，用于术中跟踪支架(3)位置和补丁(4)位置。
8.根据权利要求1所述的一种带有创口补丁的可降解支架系统，其特征在于，所述支架(3)为可降解材料制成。
9.一种如权利要求1-8任一项所述的可降解支架系统用的补丁，其特征在于，所述补丁(4)包括外层药物涂层(401)、中层贴片(402)和内层药物涂层(403)，优选的，所述外层药物涂层(401)包含促进愈合类因子，如生长因子，优选的，所述中层贴片(402)为高弹性可降解薄膜，优选的，所述内层药物涂层(403)包含抗血栓类药物，抗血栓药物如肝素、雷帕霉素。
10.一种如权利要求1-8任一项所述的可降解支架系统用的补丁，其特征在于，所述补丁(4)为纳米纤维网，在纳米纤维网的两侧带涂有可预防血栓形成的药物，如肝素、雷帕霉素和促进愈合类因子，如生长因子涂层。
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