CN103505793A - 用于导管的可分开的联接器 - Google Patents

用于导管的可分开的联接器 Download PDF

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Publication number
CN103505793A
CN103505793A CN201310240253.1A CN201310240253A CN103505793A CN 103505793 A CN103505793 A CN 103505793A CN 201310240253 A CN201310240253 A CN 201310240253A CN 103505793 A CN103505793 A CN 103505793A
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tubular body
main body
coupling
microtubular
end main
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CN201310240253.1A
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CN103505793B (zh
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P·德斯尔瓦
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Covidien LP
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Covidien LP
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    • B29C66/70General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
    • B29C66/71General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the composition of the plastics material of the parts to be joined
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    • B29C66/70General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
    • B29C66/73General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset
    • B29C66/737General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the state of the material of the parts to be joined
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    • B29C66/73791General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the state of the material of the parts to be joined degradable biodegradable
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    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/90Measuring or controlling the joining process
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    • B29C66/914Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux
    • B29C66/9141Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the temperature
    • B29C66/91411Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the temperature of the parts to be joined, e.g. the joining process taking the temperature of the parts to be joined into account
    • BPERFORMING OPERATIONS; TRANSPORTING
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    • B29C66/9141Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the temperature
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    • B29C66/91413Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the temperature of the parts to be joined, e.g. the joining process taking the temperature of the parts to be joined into account the parts to be joined having different temperatures
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C66/00General aspects of processes or apparatus for joining preformed parts
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    • B29C66/919Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux characterised by specific temperature, heat or thermal flux values or ranges
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Abstract

本发明公开一种微导管,所述微导管包括细长的柔性管状主体、末端主体以及联接器。所述细长的柔性管状主体具有近侧端部、远侧端部以及轴向延伸穿过所述管状主体的至少一个管腔。所述末端主体具有近侧端部、远侧端部以及轴向延伸穿过所述末端主体的管腔。所述联接器覆盖管状主体和末端主体二者的一部分,联接器由第一材料和第二材料制成,其中第一材料与第二材料不同。第一材料为能够与管状主体的最外层和末端主体的最外层相容的,并且第二材料构造成与管状主体和末端主体中的至少之一个形成可分开的连结部。

Description

用于导管的可分开的联接器
技术领域
本发明通常涉及微导管,并且具体地涉及具有可分开的、生物可相容的末端的微导管。
背景技术
微导管通常***身体内通过诸如股动脉的血管并且具有各种在脉管***中的用途。微导管可以用于帮助治疗各种神经血管疾病,诸如动静脉型血管畸形(AVM)和动脉瘤。
可以使用通过微导管输送的成分在血管内治疗动脉瘤和动静脉型血管畸形,所述成分在体内固化以便于永久地阻塞流动至脑动脉瘤和脑动静脉型血管畸形的血流。仅举例说明,适合的血管内成分包括在体内聚合以形成固体物质和生物可相容的溶液的氰丙烯酸酯以及在引入脉管***内时溶解在诸如二甲亚砜(“DMSO”)的非水性溶剂中的水不溶性聚合物,所述DMSO扩散于基于水的血液成分中并且聚合物沉淀于基于水的血液成分中。这样的血管内成分还包括造影剂以帮助可视化形成的物质。
栓塞成分从微导管被输送至栓塞部位。当栓塞成分在体内凝固时,可能存在成分的“回流”或“逆流”以使得微导管的远侧末端截留在其中。当这种情况发生时,医师要么必须尝试通过力取出微导管而经常导致微导管损坏,要么必须切断导管而将远侧末端留在患者脉管***内。
发明内容
因此,本发明涉及提供一种微导管,在远侧末端因任何原因截留在脉管***中的情况下所述微导管能够被安全地从患者移除,同时最小化由这些因素引起的潜在风险。
本发明涉及一种微导管,所述微导管包括细长的柔性管状主体、末端主体以及联接器。所述细长的柔性管状主体具有近侧端部、远侧端部以及轴向延伸穿过所述管状主体的至少一个管腔。所述末端主体具有近侧端部、远侧端部以及轴向延伸穿过所述末端主体的管腔。所述联接器覆盖管状主体和末端主体二者的一部分,联接器由第一材料和第二材料制成,其中第一材料与第二材料不同。第一材料为能够与管状主体的最外层和末端主体的最外层相容的。第二材料构造成与管状主体和末端主体中的至少之一个形成可分开的连结部。
在公开的实施例中,第一材料例如沿第二材料的整个长度布置在第二材料径向外侧。此处,公开的是第一材料沿第一材料的整个长度布置在第二材料径向外侧。
在公开的实施例中,第二材料与管状主体直接接触。
在公开的实施例中,第一材料从包括聚氨酯、聚乙烯、聚四氟乙烯(PTFE)、膨体聚四氟乙烯(EPTFE)、聚醚嵌段酰胺、聚氯乙烯(PVC)以及聚丙烯的组中选定。在公开的实施例中,第二材料从包括低密度聚乙烯(LDPE)、线性低密度聚乙烯(LLDPE)以及高密度聚乙烯(HDPE)的组中选定。此处,公开的是管状主体由第一材料制成。
在公开的实施例中,第三材料布置于第一材料和第二材料之间。
在公开的实施例中,第一材料为能够与亲水性涂层相容的。
在公开的实施例中,联接器为单个的单元。
在公开的实施例中,包括亲水性涂层并且亲水性涂层与管状主体、末端主体和第一材料接触。
在公开的实施例中,亲水性涂层与管状主体、末端主体和第一材料接触。
本发明还涉及一种微导管,所述微导管包括管状主体、末端主体和联接器。所述管状主体具有近侧部分、远侧部分、以及从近侧部分延伸至远侧部分以用于引入流体药剂的管腔。管状主体由第一材料制成。所述末端主体联接至管状主体的远侧部分并且限定与管状主体的管腔连通的中心管腔。所述联接器通过第一连结部与管状主体的一部分接合并且通过第二连结部与末端主体的一部分接合。联接器由至少两种不同的材料制成,所述材料包括第一材料和第二材料。第一连结部和第二连结部具有不同的连结强度。
在公开的实施例中,第一连结部比第二连结部更牢固。
在公开的实施例中,第一材料从包括聚氨酯、聚乙烯、聚四氟乙烯(PTFE)、膨体聚四氟乙烯(EPTFE)、聚醚嵌段酰胺、聚氯乙烯(PVC)以及聚丙烯的组中选定。在公开的实施例中,第二材料从包括低密度聚乙烯(LDPE)、线性低密度聚乙烯(LLDPE)以及高密度聚乙烯(HDPE)的组中选定。
本发明还涉及一种制造微导管的方法。所述方法包括:提供细长的柔性管状主体,所述管状主体具有近侧端部、远侧端部以及轴向延伸穿过所述管状主体的至少一个管腔。所述方法还包括:提供末端主体,所述末端主体具有近侧端部、远侧端部以及轴向延伸穿过所述末端主体的管腔。所述方法还包括:提供由第一材料和第二材料制成的联接器,其中第一材料与第二材料不同,其中第一材料为能够与管状主体的最外层和末端主体的最外层相容的。所述方法还包括:加热管状主体的一部分和联接器的一部分以形成管状主体和联接器之间的第一连结部;以及加热末端主体的一部分和联接器的一部分以形成末端主体和联接器之间的第二连结部。第一连结部和第二连结部具有不同的连结强度。
附图说明
参考附图将容易地理解本发明的实施例,其中:
图1为根据本发明的导管的侧平面图;
图2为图1的导管的一部分的立体图,说明管状主体、末端主体和联接器;
图3和4说明根据本发明的原理在患者脉管***的曲折区域内使用的图1和2的导管;
图5为根据本发明的联接器的第一实施例的纵向横截面图;
图5A为沿线5A-5A的图5的联接器的横向横截面图;
图5B为沿线5B-5B的图5的联接器的横向横截面图;
图6为根据本发明的联接器的第二实施例的纵向横截面图;
图6A为沿线6A-6A的图6的联接器的横向横截面图;
图6B为沿线6B-6B的图6的联接器的横向横截面图;
图7为根据本发明的联接器的第三实施例的纵向横截面图;
图7A为沿线7A-7A的图7的联接器的横向横截面图;
图7B为沿线7B-7B的图7的联接器的横向横截面图。
具体实施方式
在以下描述中,本文中使用的术语“近侧的”和“远侧的”指代微导管在管腔中的相对位置。微导管的“近侧的”或“尾侧的”端部为延伸至身体之外最靠近医师的微导管段。微导管的“远侧的”或“前侧的”端部为安放进身体管腔内距离进入部位最远的微导管段。
参考图1,微导管10能够用于输送栓塞剂至患者的脉管部位。虽然微导管能够用于身体中的任何脉管,但是微导管特别地用于栓塞神经脉管***中的动脉瘤或动静脉型血管畸形。微导管10包括管状主体段16,所述管状主体段16限定纵向轴线“a”并且具有远侧或前侧端部12以及近侧或尾侧端部14。微导管10进一步包括末端主体30,所述末端主体30与管状主体16共轴并且通过联接器100可分开地连接至或接合至管状主体16。术语“可分开地接合”或“可分开地连接”意欲包括如下解释:一旦施加撤回力则末端主体30可以从管状主体16释放,所述撤回力可以为根据微导管10的计划用途的预定值。例如,预定力可以为沿纵向轴线“a”施加于管状主体16、末端主体30或联接器100中至少之一的张力。在其他的实施例中,预定力可以为施加于部件的剪切力或径向力。术语“撤回力”通常为在朝近侧方向上沿微导管10的纵向轴线(例如平行于中心管腔22)施加的张力,所述近侧方向为将微导管从患者撤出的方向。用于将管状主体16与末端主体30分开的撤回力能够为例如不多于大约160克力,并且更具体地能够在大约10克力至大约160克力幅度之间。在某些实施例中,撤回力为大约20克力至大约40克力。在其他的实施例中,撤回力为大约30克力至大约50克力。也能够使用除上述之外的其他幅度。将在下文中更加详细地讨论联接器100的各种实施例。
参考图1和2,管状主体16和末端主体30能够具有相同的或不同的外径和内径。微导管10的近侧端部14可以包括歧管18。歧管18可以包括至少一个接近端口20,接近端口20通过细长的中心管腔22与远侧接近端口24流体连通。中心管腔22允许微导管10在导丝(未示出)上跟踪。在移除导丝之后,中心管腔22可以被用于输送栓塞剂至所需的脉管部位。虽然未特别地说明,但是微导管10可以包含多个管腔。例如,一个管腔可以被专用于导丝,而另一个管腔可以被专用于输送栓塞剂。微导管10可以包括定位于邻近管状主体16的远侧端部12的标志物32,例如不透射线标志物。标志物32能够为由金属或金属合金(诸如铂、铂/铱、金、镍钛诺等)制成的环或带。在公开的实施例中,联接器100可以填充有不透射线的材料,诸如硫酸钡。
为进一步帮助输送栓塞剂至所需的脉管部位,末端主体30可以可选地包含多个侧向孔或洞38。孔38的形状可以从圆形、椭圆、或其他形状中选定。
微导管10的整个长度能够通常为在大约150厘米至大约175厘米幅度之间,但是也可以为其他幅度。管状主体16能够被选定为具有在大约0.5毫米至大约1.5毫米幅度内的外径,但是也可以为其他直径。在一些实施例中,中心管腔22的直径能够在大约0.002英寸至大约0.005英寸之间且大于导丝(假如被使用的话)的外径。能够在近侧和远侧端部处适当地修改该直径。本领域的技术人员能够参考本发明容易地使用除本文描述的尺寸之外的其他尺寸,以适配微导管10的具体计划用途。
管状主体16能够由多种材料并且以多种方法构成。可以设想的是管状主体16由从包括聚氨酯、聚乙烯、聚四氟乙烯(PTFE)、膨体聚四氟乙烯(EPTFE)、聚醚嵌段酰胺(包括贴标为Pebax.RTM的聚醚嵌段酰胺)、聚氯乙烯(PVC)、以及聚丙烯的组中选定的材料制成。在公开的实施例中,管状主体16可以由与二甲亚砜相容的材料构成。管状主体16还可以包含具有不同柔性的区域,也能够通过采用的构造方法和材料控制所述不同的柔性。管状主体16也可以通过使各种聚合物分层而构成,诸如聚酰亚胺、聚四氟乙烯、聚醚嵌段酰胺、聚酰胺等。管状主体16可以额外地包括可变节距的编织物。末端主体30由生物可相容的材料制成。“生物可相容的”意为当被用于患者的脉管***中时材料在采用的量上为基本上无毒的并且基本上无免疫原性的。例如,可以设想的是末端主体30由从包括聚氨酯、聚乙烯、聚四氟乙烯(PTFE)、膨体聚四氟乙烯(EPTFE)、聚醚嵌段酰胺、聚氯乙烯(PVC)、以及聚丙烯的组中选定的材料制成。可以进一步设想的是末端主体30由与管状主体16相同的材料制成。
在某些实施例中,末端主体30也能够为“生物可降解的”。已知用于构造微导管末端的多种生物可降解的/生物可蚀的以及生物不可降解的材料。末端主体30能够由就地为生物可降解的或生物可吸收的材料形成。能够使用生物可降解的或生物可吸收的材料或者其一些结合物,这容许在预定条件下的生物可降解性/生物可吸收性。
多种生物可相容的-生物可降解的材料为商业可获得的并且适合于使用于这些实施例中。这些材料的示例包括DLPLA-聚(dl-丙交酯)(DLPLA-poly(dl-lactide))、LPLA-聚(l-丙交酯)(LPLA-poly(l-lactide))、PGA-聚乙交酯(PGA-polyglycolide)、PDO-聚(二恶烷酮))(PDO-poly(dioxanone))、PGA-TMC-聚(乙交酯-共-三亚甲基碳酸酯)(PGA-TMC-poly(glycolide-co-trimethylenecarbonate))、PGA-LPLA-聚(l-丙交酯-共-乙交酯)(PGA-LPLA-poly(l-lactide-co-glycolide))、PGA-DLPLA-聚(dl-丙交酯-共-乙交酯)(PGA-DLPLA-poly(dl-lactide-co-glycolide))、LPLA-DLPLA-聚(l-丙交酯-共-dl-丙交酯)(LPLA-DLPLA-poly(l-lactide-co-dl-lactide))、以及PDO-PGA-TMC-聚(乙交酯-共-三亚甲基-共-二恶烷酮)(PDO-PGA-TMC-poly(glycolide-co-trimethylene-co-dioxanone))。
可以进一步设想的是,润滑涂层可以布置于微导管10的部件(包括管状主体16、联接器10和末端主体30)上方。适合的润滑涂层包括诸如聚乙烯吡咯烷酮(PVP)、聚环氧乙烷、聚乙二醇、纤维素聚合物和亲水性马来酸酐的亲水性材料,或者诸如硅树脂、PEFE或FEP的疏水性材料。这些涂层通常通过浸渍涂敷或喷射法施加,并且可以使用热固化或紫外线(UV)固化。例如,高达大约70摄氏度的固化温度用于硅树脂涂层,并且可能需要几百摄氏度用于PTFE涂层。除了润滑涂层之外,生物活性的涂层可以被施加于微导管的全部或一部分上。这些涂层还可以包含诸如肝磷脂、水蛭素及其类似物或其他药物的材料。这些涂层通常通过浸渍涂敷被施加。为防止血液凝结或用于输送药物至特定的部位,生物活性的涂层为理想的。
在附图中示出联接器100的各种实施例。参考图5-5B,示出联接器100a的第一实施例。联接器100a由第一材料110a和第二材料120a制成。额外地,可选的第三材料130a被示出为在第一材料110a和第二材料120a之间,并且可以被用于形成第一材料110a和第二材料120a之间的连结。在图5-5B中说明的实施例中,第一材料110a和第二材料120a在联接器100a的整个长度“L”上延伸。额外地,第一材料110a沿联接器100a的整个长度“L”布置在第二材料120a的径向外侧。
可以设想的是,联接器100a的第一材料110a包括能够与管状主体16的最外层和末端主体30的最外层相容的材料,诸如上述亲水性涂层。正如能够被理解的,能够与亲水性涂层相容的材料包括能够通过浸渍、海绵涂敷(sponge coating)、喷射或本领域已知的任何其他传统的涂敷技术将亲水性涂层粘附至其的材料。例如,可以设想的是,第一材料110a包括聚氨酯、聚乙烯、聚四氟乙烯(PTFE)、膨体聚四氟乙烯(EPTFE)、聚醚嵌段酰胺、聚氯乙烯(PVC)、或聚丙烯。可以进一步设想的是,第一材料100a为与制成管状主体16的材料相同的材料。
关于联接器100a的第二材料120a,可以设想的是,第二材料120a包括能够与管状主体16形成连结并且与末端主体30形成可分开连结的材料。因此,可以设想的是,联接器100a的第二材料120a例如包括低密度聚乙烯(LDPE)、线性低密度聚乙烯(LLDPE)或高密度聚乙烯(HDPE)。例如在管状主体16由与制成末端主体30相同的材料制成的实施例中,可以设想的是,通过以不同的温度加热连结部而形成具有不同连结强度的连结部。例如,为了提供管状主体16和联接器100a之间的相对强的连结,能够通过以例如大约350华氏度和大约354华氏度之间的温度持续加热区域例如大约7秒钟而产生连结;为提供末端主体30和联接器100a之间的相对弱的连结,能够通过以例如大约246华氏度和大约250华氏度之间的温度持续加热区域例如大约6秒钟而产生连结。
因此,在公开的实施例中,联接器100a通过相对于连接联接器100a和末端主体30的连结强度来说强的连结而附接至管状主体16。在这些实施例中,通过医师施加的适合的撤回力将导致联接器100a从末端主体30分开,并且联接器100a保持连接至管状主体16。正如能够被理解的,能够根据所需的结果转换强连结和弱连结。在公开的实施例中,第一材料100a为聚醚嵌段酰胺,第二材料120a为低密度聚乙烯,并且管状主体16的至少一部分为聚醚嵌段酰胺。
额外地,可以用于形成第一材料110a和第二材料120a之间的连结部的第三材料130a能够由Plexar,TYMAXTM或DupontTM
Figure BDA00003358835500081
制成。具体地,可以设想的是,当第一材料110a由Pebax制成并且当第二材料120a由LDPE制成时,第三材料130a由Plexar制成。
参考图6-6C,联接器100的第二实施例被示出并且被表示为联接器100b。联接器100b由第一材料110b和第二材料120b制成。如所示,第一材料110b沿第二材料120b的整个长度布置为在第二材料120b的径向外侧。额外地,存在第一材料110b和第二材料120b之间的区别线140b,以使得第二材料120b仅延伸联接器100b的长度“L”的一部分。虽然区别线140b被示出为在联接器100b的纵向中点附近,但是可以设想的是区别线140b定位为与示出的位置相比更靠向近侧或靠向远侧。额外地,可以设想的是,第一材料110b从与第一材料110a相同的材料组中选定,并且第二材料120b从与第二材料120a相同的材料组中选定。进一步地,虽然未明确地说明,但是第三材料可以布置于第一材料110b和第二材料120b之间,并且可以包括与第三材料130a相同的材料。
参考图7-7C,联接器100的第三实施例被示出并且表示为联接器100c。联接器100c由第一材料110c和第二材料120c制成。如所示,第一材料110c的整体布置为在第二材料120c整体的近侧。额外地,存在第一材料110c和第二材料120c之间的区别线140c。虽然区别线140c被示出为靠近联接器100c的纵向中点并且邻近管状主体16和末端主体30的结合部,但是可以设想的是区别线140c定位为与示出的位置相比更靠向近侧或靠向远侧。额外地,可以设想的是第一材料110c从与第一材料110a相同的材料组中选定,并且第二材料120c从与第二材料120a相同的材料组中选定。进一步地,虽然未明确地说明,但是第三材料可以布置于第一材料110c和第二材料120c之间,并且可以从与第三材料130a相同的材料组中选定。
再次参考图3,说明微导管10在人体内的使用。特别地,微导管10在方便的位置(诸如腹股沟)被***患者内。微导管10被推进穿过脉管***,直至末端主体30到达治疗部位40(诸如例如AVM或者动脉瘤)为止。通过可视化不透射线标志物32能够监测微导管10的位置。一旦微导管10处于其在脉管***中的适当位置中,则栓塞剂42能够被输送至治疗部位40。栓塞剂42能够为液体栓塞剂并且能够包括若干物质。适合的栓塞剂42包括包含生物可相容的聚合物以及就地聚合的预聚物的栓塞剂。液体栓塞剂还能够包括生物可相容的溶剂和造影剂。在一个实施例中,造影剂为可溶解于水的。一个这样的示例为可从加利福尼亚州Irvine的Tyco Healthcare Group LP dbaCovidien商业上获得的非粘合液体栓塞剂OnyxTM,其包括溶解于DMSO(二甲亚砜)中的EVOH(乙烯-乙烯醇)共聚物以及悬浮微粒化钽粉以提供用于通过荧光透视法可视化的造影。在美国专利NO.5,667,767;5,695,480;6,051,607;6,342,202;6,531,111;以及6,562,317中说明适合的栓塞剂的其他描述,所述美国专利的全部内容纳入本文加以参考并且组成本说明书的一部分。
参考图3和4,在输送栓塞剂42后,末端主体30能够被截留在栓塞剂42内。为从患者移除微导管10,主治医师能够施加撤回力至管状主体16。通常,当施加撤回力时,联接器100能够:1)保持附接至末端主体30;或者2)保持附接至管状主体16;或者3)***为两个部件,因此保持部分地附接至管状主体16和部分地附接至末端主体30。
在施加力之后联接器100的状态能够受到用于将联接器100接合至末端主体30和管状主体16的部件构造的材料以及方法的影响。能够以多种方式完成末端主体30与联接器100的接合以及管状主体16与联接器100的接合。例如,联接器100能够与管状主体16的远侧端部34重叠和/或与末端主体30的近侧端部36重叠(见图2)。重叠的量能够为在确定用于分开末端主体30的撤回力时的因素。在一些实施例中,联接器100与末端主体30的附接或联接器100与管状主体16的附接中的一个或两个能够为对接接头(端部至端部)。在一些实施例中,远侧端部34和近侧端部36能够形成对接接头。
本发明还涉及制造微导管10和/或联接器100的方法,如本文中所公开的。因此,可以设想的是,通过混合挤压或者通过模具(例如模制或包覆模制)制成用于与微导管100一同使用的联接器100。额外地,如上所讨论的,可以设想的是,联接器100通过热连结而连结至导管10。具体地,可以通过将联接器100/管状主体16加热至大约350华氏度和大约354华氏度之间的温度大约7秒钟而将联接器100连结至管状主体16,并且可以通过将联接器100/末端主体30加热至大约246华氏度和大约250华氏度之间的温度大约6秒钟而将联接器100连结至末端主体30。当应用热源时,联接器100能够通过机械连结(环绕较小的管状主体16和末端主体30的热收缩力)或者通过熔合连结(其中联接器100、管状主体16、和/或末端主体30的材料融合在一起)而附接至管状主体16和末端主体30。
在替代的构造方法中,联接器100能够通过使用粘合剂、热空气、激光、热压模、等离子体处理或溶剂连结而附接至末端主体30和/或管状主体16。
可以进一步设想的是,能够存在联接器100与管状主体16和/或末端主体30的不同重叠量。重叠量能够为将末端主体30与管状主体16和/或联接器100分离所需的撤回力中的一个因素。例如,可以设想的是,联接器100在管状主体16和/或末端主体30上的重叠越大,将两个部件分开所需的撤回力越大。在一些实施例中,该重叠能够为大约0.5毫米至大约5毫米。在一些实施例中,该重叠能够为大约2毫米至大约4毫米。其他重叠范围也是可以的。
上述描述和附图用于描述本发明的实施例,而非意欲以任何方式限制本发明的范围。例如,虽然联接器100a-100c中的每一个实施例说明管状主体16与末端主体30接触,但是可以设想的是管状主体16与末端主体30之间存在空间。对于本领域的技术人员来说显而易见的是能够做出各种修改和改变而不脱离本发明的范围。因此,意欲的是本发明覆盖本发明的修改和变化,只要其在附属权利要求及其等价物的范围之内。

Claims (20)

1.一种微导管,所述微导管包括:
细长的柔性管状主体,所述管状主体具有近侧端部、远侧端部以及轴向延伸穿过所述管状主体的至少一个管腔;
末端主体,所述末端主体具有近侧端部、远侧端部以及轴向延伸穿过所述末端主体的管腔;以及
联接器,所述联接器覆盖管状主体和末端主体二者的一部分,联接器由第一材料和第二材料制成,其中第一材料与第二材料不同,其中第一材料为能够与管状主体的最外层和末端主体的最外层相容的,其中第二材料构造成与管状主体和末端主体中的至少之一个形成可分开的连结部。
2.根据权利要求1所述的微导管,其中第一材料布置在第二材料径向外侧。
3.根据权利要求1所述的微导管,其中第一材料沿第二材料的整个长度布置在第二材料径向外侧。
4.根据权利要求3所述的微导管,其中第一材料沿第一材料的整个长度布置在第二材料径向外侧。
5.根据权利要求1所述的微导管,其中第二材料与管状主体直接接触。
6.根据权利要求1所述的微导管,其中第一材料为能够与亲水性涂层相容的。
7.根据权利要求1所述的微导管,其中第一材料从包括聚氨酯、聚乙烯、聚四氟乙烯(PTFE)、膨体聚四氟乙烯(EPTFE)、聚醚嵌段酰胺、聚氯乙烯(PVC)以及聚丙烯的组中选定。
8.根据权利要求1所述的微导管,其中第二材料从包括低密度聚乙烯(LDPE)、线性低密度聚乙烯(LLDPE)以及高密度聚乙烯(HDPE)的组中选定。
9.根据权利要求6所述的微导管,其中第二材料从包括低密度聚乙烯(LDPE)、线性低密度聚乙烯(LLDPE)以及高密度聚乙烯(HDPE)的组中选定。
10.根据权利要求1所述的微导管,其中管状主体由第一材料制成。
11.根据权利要求7所述的微导管,其中管状主体由第一材料制成。
12.根据权利要求1所述的微导管,其中第一材料为聚醚嵌段酰胺,并且其中第二材料为低密度聚乙烯,并且其中管状主体的至少一部分由聚醚嵌段酰胺制成。
13.根据权利要求1所述的微导管,进一步包括布置于第一材料和第二材料之间的第三材料。
14.根据权利要求1所述的微导管,其中联接器为单个的单元。
15.根据权利要求6所述的微导管,进一步包括与管状主体、末端主体和第一材料接触的亲水性涂层。
16.一种微导管,所述微导管包括:
管状主体,所述管状主体具有近侧部分、远侧部分、以及从近侧部分延伸至远侧部分以用于引入流体药剂的管腔,管状主体由第一材料制成;
末端主体,所述末端主体联接至管状主体的远侧部分并且限定与管状主体的管腔连通的中心管腔;以及
联接器,所述联接器通过第一连结部与管状主体的一部分接合并且通过第二连结部与末端主体的一部分接合,联接器由至少两种不同的材料制成,所述材料包括第一材料和第二材料;
其中第一连结部和第二连结部具有不同的连结强度。
17.根据权利要求16所述的微导管,其中第一连结部比第二连结部强度高。
18.根据权利要求16所述的微导管,其中第一材料从包括聚氨酯、聚乙烯、聚四氟乙烯(PTFE)、膨体聚四氟乙烯(EPTFE)、聚醚嵌段酰胺、聚氯乙烯(PVC)以及聚丙烯的组中选定。
19.根据权利要求18所述的微导管,其中第二材料从包括低密度聚乙烯(LDPE)、线性低密度聚乙烯(LLDPE)以及高密度聚乙烯(HDPE)的组中选定。
20.一种制造微导管的方法,所述方法包括:
提供细长的柔性管状主体,所述管状主体具有近侧端部、远侧端部以及轴向延伸穿过所述管状主体的至少一个管腔;
提供末端主体,所述末端主体具有近侧端部、远侧端部以及轴向延伸穿过所述末端主体的管腔;以及
提供由第一材料和第二材料制成的联接器,其中第一材料与第二材料不同,其中第一材料为能够与管状主体的最外层和末端主体的最外层相容的;
加热管状主体的一部分和联接器的一部分以形成管状主体和联接器之间的第一连结部;以及
加热末端主体的一部分和联接器的一部分以形成末端主体和联接器之间的第二连结部;
其中第一连结部和第二连结部具有不同的强度。
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CA2815040A1 (en) 2013-12-19
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CN103505793B (zh) 2016-08-10

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