CN117503441B - 一种可回收药物支架及支架系统 - Google Patents
一种可回收药物支架及支架系统 Download PDFInfo
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Abstract
本发明公开了一种可回收药物支架及支架系统,所述支架具有弹性的,所述支架包括支撑柱、加强柱和固定锚,支撑柱和加强柱设置有多个,加强柱将相邻两个的支撑柱进行连接,本发明中,支架是通过微创植入的方式将药物支架置入前列腺尿道中,用于扩张、重塑前列腺尿道,而无需烧灼或切割前列腺,然后将其留置在患者体内5至7天,这期间支架会通过自身的扩张力打开前列腺尿道,让尿液可以顺畅的流动和排出,支架上的药物转移到扩张区域,抑制尿道受支架的压迫扩张造成的细胞增殖,同时重塑前列腺尿道并保持尿道通畅,到期药物释放完毕。
Description
技术领域
本发明涉及医疗器械技术领域,具体涉及一种可回收药物支架及支架系统。
背景技术
前列腺增生是引起中老年男性排尿障碍的最常见的疾病,前列腺增生的治疗方法包括常规外科手术治疗、激光治疗及微创介入治疗。
目前前列腺增生的治疗方法存在诸多缺陷:
1.常规外科手术治疗中因创面凝固较薄而导致难以止血,术中出现的高温而使创面更易结痂影响手术视野,进一步带来严重并发症的危险,高温对尿道也是一种损伤,尿道狭窄等并发症案例也有报道。
2.激光治疗中如果医生的激光手术操作不熟练,会导致患者的临近脏器出现损伤;其相对于传统前列腺电切术的费用高,术后少数病人会出现性功能方面的影响。
3.微创介入治疗是通过引入支架,并利用支架支撑前列腺组织而打开前列腺尿道腔、实现排尿的方法,由于长时间置于人体内,可能在一定时间后发生位移,从而对该支架的使用效果以及取出等造成不利影响,并且在支架取出后期又有很高的尿路梗阻性风险。
发明内容
为解决上述技术问题,本发明提供一种可回收药物支架,所述支架具有弹性的,所述支架由管材切割而成,所述支架包括支撑柱、加强柱和固定锚,固定锚的远端与支撑柱的近端连接,固定锚为螺旋形设计,支撑柱和加强柱设置有多个,加强柱将相邻两个的支撑柱进行连接,所述支架的近端设置有内孔。
优选的:所述支架表面涂覆有药物涂层,药物涂层包括生物活性剂。
优选的:所述生物活性剂选自抗肿瘤剂、抗增殖剂、抗生素、抗凝剂、抗血栓成形剂、抗炎药的一种或至少两种的组合。
优选的:所述药物涂层的成分选自西罗莫司、紫杉醇、三氧化二砷、佐他莫司、肝素、依维莫司、他维莫司或雷帕霉素中的任意一种或至少两种的组合、水蛭素、前列环素、阿昔单抗、地塞米松、甲基强的松龙、双磷酸盐脂质体的一种或至少两种的组合。
优选的:所述支架为多边形形状,支架侧截面呈锐角等腰三角形形状。
优选的:所述加强柱与支撑柱一体成型,加强柱的中间部位为锐角设计。
一种支架系统,支架系统用于输送和回收支架。
优选的:所述支架系统包括助推管、回收线和输送鞘,所述助推管的尾端可插入内孔中,将所述助推管旋转的同时带动所述支架一起旋转,所述输送鞘可活动的套在所述助推管上,且用于包裹所述支架。
优选的:所述支架系统还包括回收系统,回收系统包括回收鞘和回收钢丝,回收钢丝用于使回收线穿过回收鞘,回收鞘用于包裹支架,将支架收缩至回收鞘内。
本发明的技术效果和优点:
1、本发明中,支架是通过微创植入的方式将药物支架置入前列腺尿道中,用于扩张、重塑前列腺尿道,而无需烧灼或切割前列腺,然后将其留置在患者体内5至7天,这期间支架会通过自身的扩张力打开前列腺尿道,让尿液可以顺畅的流动和排出。
2、本发明中,支架上的药物转移到扩张区域,抑制尿道受支架的压迫扩张造成的细胞增殖,同时重塑前列腺尿道并保持尿道通畅,到期药物释放完毕。
3、本发明中,通过设置的回收系统,将整个支架系统撤出体外,药物在体内继续存在28天以上,持续重塑前列腺尿道,患者的尿路梗阻性症状会迅速得到缓解和长久改善。
附图说明
图1是本申请实施例提供的新型医用支架的结构示意图;
图2是本申请实施例提供的支架系统的结构示意图;
图3是本申请实施例提供的支架系统中图2中A处的结构放大示意图;
图4是本申请实施例提供的支架系统中图2中B处的结构放大示意图;
图5是本申请实施例提供的支架系统中回收系统的结构示意图;
图6是本申请实施例提供的支架系统中支架和回收钢线的连接结构示意图。
图中:1、支架系统;10、支架;11、支撑柱;12、加强柱;13、固定锚;14、内孔;20、助推管;30、回收线;40、输送鞘;50、回收系统;51、回收鞘;52、回收钢丝。
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所示,在本发明中提供一种可回收药物支架,支架10具有弹性的,能够被收缩成收缩结构,支架10由管材切割而成,支架10内所有的近端相互连接,所有的远端相互连接。
在本实施例中,支架10包括支撑柱11、加强柱12和固定锚13,支撑柱11和加强柱12设置有多个,加强柱12将相邻两个的支撑柱11进行连接,加强柱12给支撑柱11提供支撑力。
优选的,加强柱12与支撑柱11一体成型,从而大大提高加强柱12和支撑柱11的强度。
在本实施例中,支架10为多边形形状,支架10侧截面呈锐角等腰三角形形状,具体的,加强柱12中间部位为锐角设计,加强柱12回收时更加容易形变,进而方便将支架10压缩至输送鞘40和回收鞘51中。
在本实施例中,固定锚13的远端与支撑柱11的近端连接,固定锚13由包括但不限于丝材制成,起到防止医用支架10向远端方向产生位移的作用。
具体的,固定锚13为螺旋形设计,螺旋形结构可以是圆形或多边形结构,方便将支架10收缩至输送鞘40或回收鞘51中,因螺旋形状的固定锚13具有弹性,当固定锚13收缩至输送鞘40或回收鞘51中,由螺旋形状收缩成直线形状,当固定锚13移动至输送鞘40或回收鞘51外,固定锚13恢复螺旋形状。
在本实施例中,支撑柱11的近端与固定锚13的近端连接,连接的方式包括但不限于铆压、打胶和焊接。
在本发明中提供一种可回收药物支架用的药物涂层,应用于支架10上,药物涂层包括生物活性剂或生物活性剂和载体。
具体的,生物活性剂选自包括但不限于抗肿瘤剂、抗增殖剂、抗生素、抗凝剂、抗血栓成形剂、抗炎药。
具体的,药物涂层的成分包括但不限于西罗莫司、紫杉醇、砒霜、佐他莫司、肝素、依维莫司、他维莫司或雷帕霉素中的任意一种或至少两种的组合、水蛭素、前列环素、阿昔单抗、地塞米松、甲基强的松龙、双磷酸盐脂质体。
具体的,药物涂层可采用喷涂或浸涂的方式涂覆在支架10上。
具体的,载体可以是可吸收生物相容性材料或聚合物。
本发明的支架10是通过微创植入的方式置入前列腺尿道中,用于扩张、重塑前列腺尿道,而无需烧灼或切割前列腺,然后将其留置在患者体内5至7天,这期间支架10会通过自身的扩张力打开前列腺尿道,让尿液可以顺畅的流动和排出,支架10上的药物转移到扩张区域,抑制尿道受支架10的压迫扩张造成的细胞增殖,同时重塑前列腺尿道并保持尿道通畅,到期药物释放完毕,支架10回收,通过整个支架系统撤出体外,药物在体内继续存在28天以上,持续重塑前列腺尿道,患者的尿路梗阻性症状会迅速得到缓解和长久改善。
进一步的,支架10的近端设置有内孔14,内孔14采用多边形或圆形设计。
参阅图2~4所示,在本实施例中提供一种可回收药物支架用的支架系统,支架系统1包括助推管20、回收线30和输送鞘40,助推管20的尾端可插入内孔14中,从而可将助推管20旋转的同时带动支架10一起旋转。
具体的,回收线30与支架10近端连接,可采用铆压、打胶的方式连接,并穿过助推管20的内孔,在助推管20的近端打结。
具体的,输送鞘40可活动的套在助推管20上,且用于包裹支架10,可将支架10收缩至输送鞘40内,输送鞘40的近端具有叶片状把手设计,叶片状把手起到方便操作,防止在放置支架10时输送鞘40跟随支架10深入人体组织,从而提高输送鞘40放置的成功率,并且输送鞘40近端的内孔与助推管20直径相似,防止在放置支架10过程中,膀胱无法达到充盈状态。
参阅图5~6所示,在本实施例中,支架系统1还包括回收系统50,回收系统50包括回收鞘51和回收钢丝52,回收钢丝52用于使回收线30穿过回收鞘51,回收鞘51用于包裹支架10,将支架10收缩至回收鞘51内,并移除体内,从而方便将支架10与回收鞘51移除体内。
进一步的,回收鞘51近端设置有把手,把手设置成叶片状,在回收过程中,方便操作回收鞘51。
本支架系统使用前,将助推管20插入支架10的内孔中,回收线30穿过助推管20内孔在助推管20的近端打结,再将助推管20插入输送鞘40,使得支架10收缩至输送鞘40中,支架10处于收缩状态;
使用时,将输送鞘40和助推管20植入前列腺尿道中,并且支架10位于尿道狭窄处的内侧,再取出输送鞘40,输送鞘40与支架10分离后,支架10处于打开状态,将取出的输送鞘40再植入前列腺尿道中且位于助推管20外侧处,用于将前列腺尿道撑开,向外拉动助推管20,将打开的支架10移动至尿道狭窄处,起到支撑的作用,剪断助推管20的近端和回收线30的打结,再取出助推管20,此时助推管20与支架10分离后,支架10处于打开状态,此时回收线30近端位于尿道外侧处;
待前列腺尿道重新塑造后,回收时,将回收钢丝52固定在回收线30近端,回收钢丝52和回收线30穿过回收鞘51,回收鞘51植入前列腺尿道中,将支架10收缩至回收鞘51中并移除体内。
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 (9)
1.一种可回收药物支架,所述支架(10)具有弹性,其特征在于,所述支架(10)由管材切割而成,所述支架(10)包括支撑柱(11)、加强柱(12)和固定锚(13),固定锚(13)的远端与支撑柱(11)的近端连接,固定锚(13)为螺旋形设计,固定锚(13)由丝材制成,用于防止支架(10)向远端方向产生位移,支撑柱(11)和加强柱(12)设置有多个,加强柱(12)将相邻两个支撑柱(11)进行连接,所述支撑柱(11)的近端汇聚形成内孔(14),内孔(14)用于插入助推管(20)。
2.根据权利要求1所述的可回收药物支架,其特征在于,所述支架(10)表面涂覆有药物涂层,药物涂层包括生物活性剂。
3.根据权利要求2所述的可回收药物支架,其特征在于,所述生物活性剂选自抗肿瘤剂、抗增殖剂、抗生素、抗凝剂、抗血栓成形剂、抗炎药的一种或至少两种的组合。
4.根据权利要求2所述的可回收药物支架,其特征在于,所述药物涂层的成分选自西罗莫司、紫杉醇、三氧化二砷、佐他莫司、肝素、依维莫司、他维莫司或雷帕霉素中的任意一种或至少两种的组合、水蛭素、前列环素、阿昔单抗、地塞米松、甲基强的松龙、双磷酸盐脂质体的一种或至少两种的组合。
5.根据权利要求1所述的可回收药物支架,其特征在于,所述支架(10)为多边形形状,支架(10)侧截面呈锐角等腰三角形形状。
6.根据权利要求1所述的可回收药物支架,其特征在于,所述加强柱(12)与支撑柱(11)一体成型,加强柱(12)的中间部位为锐角设计。
7.一种支架系统,其特征在于,所述支架系统(1)用于输送和回收权利要求1-6任一项所述支架(10)。
8.根据权利要求7所述的支架系统,其特征在于,所述支架系统(1)包括助推管(20)、回收线(30)和输送鞘(40),所述助推管(20)的尾端可插入内孔(14)中,将所述助推管(20)旋转的同时带动所述支架(10)一起旋转,所述输送鞘(40)可活动的套在所述助推管(20)上,且用于包裹所述支架(10)。
9.根据权利要求8所述的支架系统,其特征在于,所述支架系统(1)还包括回收系统(50),回收系统(50)包括回收鞘(51)和回收钢丝(52),回收钢丝(52)用于使回收线(30)穿过回收鞘(51),回收鞘(51)用于包裹支架(10),将支架(10)收缩至回收鞘(51)内。
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