CN111344034B - 用于导管灌注的流体存储单元、系统和方法 - Google Patents

用于导管灌注的流体存储单元、系统和方法 Download PDF

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CN111344034B
CN111344034B CN201880073076.3A CN201880073076A CN111344034B CN 111344034 B CN111344034 B CN 111344034B CN 201880073076 A CN201880073076 A CN 201880073076A CN 111344034 B CN111344034 B CN 111344034B
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storage unit
catheter
fluid storage
distal end
actuator
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CN111344034A (zh
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J·K·S·奈杜
伍文彪
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Becton Dickinson and Co
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Abstract

一种导管系统(10)包括导管组件和填充有流体的流体存储单元(20)。所述导管组件包括导管毂(12)、导管(15)、延伸管(16)以及适配器(18)。所述导管毂包括远端、近端、在所述远端与所述近端之间延伸的内腔、以及侧端口(14)。所述导管(15)从所述导管毂(12)的所述远端向远侧延伸。所述延伸管(16)的远端联接到所述侧端口(14)。所述适配器(18)联接到所述延伸管(16)的近端。所述流体存储单元(20)联接到所述适配器(18),并且包括贮存器、阻隔件以及致动器。所述流体设置在所述贮存器内。响应于所述致动器对所述阻隔件的突破,所述贮存器与所述导管毂的所述内腔流体连通。

Description

用于导管灌注的流体存储单元、系统和方法
背景技术
导管通常用于多种输注疗法。例如,导管可以用于将诸如生理盐溶液、各种药物和总肠胃外营养物的流体输注到患者体内。导管还可以用于从患者体内抽血。在一些情况下,用于流体输注的导管和附接的管组可以在插入患者的脉管系统中之前被灌注以去除空气。如果允许气泡进入患者的脉管系统,则可能形成栓塞,这可能对患者造成严重伤害。
发明内容
本公开总体上涉及流体存储单元以及相关的系统和方法。在一些实施例中,流体存储单元可以促进导管组件的灌注,这可以防止使用预填充的注射器或连接到IV滴注器以灌注导管组件。在一些实施例中,导管组件可以包括IV导管组件。在一些实施例中,在将导管组件导管插入(catheterization)或插入患者的脉管系统中之前,可以激活流体存储单元以释放流体存储单元内的流体并促进导管组件的灌注。
在一些实施例中,导管系统可以包括导管组件,所述导管组件可以包括导管毂。在一些实施例中,导管毂可以包括远端、近端以及在远端与近端之间延伸的内腔。在一些实施例中,导管毂可以包括侧端口。
在一些实施例中,导管组件可以包括导管,所述导管可以从导管毂的远端向远侧延伸。在一些实施例中,导管组件可以包括延伸管,所述延伸管可以包括远端和近端。在一些实施例中,延伸管的远端可以联接到侧端口。
在一些实施例中,导管组件可以包括联接到延伸管的近端的适配器。在一些实施例中,适配器可以包括Y形适配器或另一种合适的适配器。在一些实施例中,导管系统可以包括流体存储单元。在一些实施例中,流体存储单元可以联接到适配器。在一些实施例中,流体存储单元可以包括以下中的一个或多个:贮存器、阻隔件和致动器。在一些实施例中,响应于致动器对阻隔件的突破,贮存器可以与导管毂的内腔流体连通。在一些实施例中,导管系统可以包括设置在贮存器内的流体,所述流体可以用于灌注导管组件。
在一些实施例中,响应于致动器对阻隔件的突破、和/或流体存储单元的挤压,流体可以从贮存器流入导管毂的内腔中。在这些和其他实施例中,流体存储单元可以朝向流体存储单元的与致动器对准的轴线压缩并且/或者流体存储单元可以朝向流体存储单元的垂直于致动器的轴线压缩。在一些实施例中,响应于使流体存储单元的近侧部分和流体存储单元的远端更靠近在一起,阻隔件可以由致动器突破。在一些实施例中,响应于将流体存储单元的近侧部分推向适配器和/或将适配器推向流体存储单元的近侧部分,可以使流体存储单元的近侧部分和流体存储单元的远端更靠近在一起。
在一些实施例中,流体存储单元的远端可以包括鲁尔适配器,所述鲁尔适配器可以允许流体存储单元的远端联接到适配器。在一些实施例中,致动器可以包括空心钉。在一些实施例中,阻隔件可以包括隔膜。在一些实施例中,阻隔件可以包括膜,所述膜可以是疏水的。在一些实施例中,膜的疏水性可以防止流体从贮存器中泄漏出。
在一些实施例中,一种方法可以包括提供导管系统。在一些实施例中,所述方法可以包括用致动器突破阻隔件,以使得贮存器与导管毂的内腔流体连通。在一些实施例中,所述方法可以包括挤压流体存储单元,以使得流体从贮存器流入导管毂的内腔中。在一些实施例中,用致动器突破阻隔件可以包括使流体存储单元的近侧部分和流体存储单元的远端更靠近在一起。
应理解,以上概述和以下详述都仅是示例性和解释性的,而不限制受权利要求书保护的本发明。
附图说明
将通过使用附图用附加的特异性和细节来描述和解释示例性实施例,在附图中:
图1是根据一些实施例的示例性导管系统的上部透视图;
图2A是根据一些实施例的图1的导管系统的示例性流体存储单元和示例性适配器的剖视图;
图2B是根据一些实施例的图2A的流体存储单元和适配器的剖视图,示出由示例性致动器突破的示例性阻隔件;
图3A是根据一些实施例的图1的导管系统的示例性导管毂的剖视图;
图3B是根据一些实施例的被配置成与图3A的导管毂联接的示例性针座的上部透视图;并且
图4是示出根据一些实施例的灌注导管组件的示例性方法的框图。
具体实施方式
本公开总体上涉及流体存储单元以及相关的系统和方法。在一些实施例中,流体存储单元可以促进导管组件的灌注,这可以防止使用预填充的注射器或连接到IV滴注器以灌注导管组件。
现在参考图1,在一些实施例中,导管系统10可以包括导管组件,所述导管组件可以包括导管毂12。在一些实施例中,导管毂12可以包括远端、近端以及在远端与近端之间延伸的内腔。在一些实施例中,导管毂12可以包括侧端口14。
如在本公开中所用,术语“近侧”和“远侧”可以分别是指更接近和远离将导管系统放置成与患者接触的临床医生的方向。例如,在插入过程中首先接触患者身体的导管系统10的端部将是导管系统10的远端,而导管系统10的相对端部将是导管系统10的近端。
在一些实施例中,导管组件可以包括导管15,所述导管可以固定在导管毂12的远端内和/或从所述远端向远侧延伸。在一些实施例中,导管组件可以包括外围IV导管组件。在一些实施例中,导管组件可以包括封闭IV导管组件,诸如像,Becton Dickinson NEXIVATMClosed IV Catheter System或Becton Dickinson NEXIVATM DIFFUSICSTM Closed IVCatheter System。在这些和其他实施例中,导管组件可以包括延伸管16,所述延伸管可以包括远端和近端。在一些实施例中,延伸管的远端可以联接到侧端口14。在一些实施例中,导管组件可以包括另一类型的导管组件,诸如像非集成导管组件或不具有延伸管16的导管组件。
在一些实施例中,导管组件可以包括适配器18,所述适配器可以联接到延伸管16的近端。在一些实施例中,适配器18可以包括Y形适配器或另一种合适的适配器。
在一些实施例中,导管系统10可以包括流体存储单元20。在一些实施例中,流体存储单元20可以被激活以释放流体存储单元20内的流体,并且可以促进导管组件的灌注。
在一些实施例中,流体存储单元20可以联接到适配器18。现在参考图2A至图2B,在一些实施例中,流体存储单元20可以包括以下中的一个或多个:贮存器22、阻隔件24和致动器26。在一些实施例中,响应于致动器26对阻隔件24的突破,贮存器22可以与导管毂12的内腔流体连通。在一些实施例中,导管系统10可以包括设置在贮存器22内的流体28,所述流体可以用于灌注导管组件。在一些实施例中,流体28可以包括盐溶液或另一种合适的灌注流体。在一些实施例中,突破阻隔件24可以包括穿透、刺穿或另一种类型的突破。
在一些实施例中,导管组件的灌注可以实现导管组件的无气泡流体路径。在一些实施例中,导管组件的流体路径可以包括以下中的一个或多个:导管15、导管毂12、延伸管16和适配器18。在一些实施例中,导管组件的灌注可以在将导管组件导管插入或插入患者的脉管系统中之前发生。
在一些实施例中,响应于致动器26对阻隔件24的突破、和流体存储单元20的挤压,流体28可以从贮存器22流动通过导管组件的整个流体路径和/或流入导管组件中。因此,在一些实施例中,响应于致动器26对阻隔件24的突破、和流体存储单元20的挤压,流体28可以从贮存器22流入导管毂12的内腔中,并且可以灌注导管组件。在这些和其他实施例中,流体存储单元20可以朝向流体存储单元的与致动器26对准的轴线30压缩并且/或者流体存储单元20可以朝向流体存储单元20的垂直于致动器26的另一轴线32压缩。在一些实施例中,例如,如图2B所示,响应于使流体存储单元20的近侧部分和流体存储单元20的远端更靠近在一起,阻隔件24可以由致动器26突破。在一些实施例中,流体存储单元20可以由柔性或半柔性材料构造,这可以促进流体存储单元20的压缩和/或移动。例如,流体存储单元20可以由塑料构造。
在一些实施例中,响应于将流体存储单元20的近侧部分推向适配器18和/或将适配器18推向流体存储单元20的近侧部分,可以使流体存储单元20的近侧部分和流体存储单元20的远端更靠近在一起。
在一些实施例中,流体存储单元20的远端可以包括鲁尔适配器34或另一联接机构,所述鲁尔适配器或另一联接机构可以允许流体存储单元20的远端联接到适配器18。在一些实施例中,鲁尔适配器34可以防止泄漏和/或微生物的进入。例如,流体存储单元20的远端可以包括公鲁尔,所述公鲁尔可以联接到适配器18的母鲁尔。可替代地,例如,流体存储单元20的远端可以包括母鲁尔,所述母鲁尔可以联接到适配器18的公鲁尔。在一些实施例中,在导管组件的灌注之后,流体存储单元20可以从导管组件移除和/或连接到输注装置,诸如像IV滴注器。在一些实施例中,可以将流体存储单元20从适配器18解耦并移除,并且用另一个流体存储单元20代替,这可以促进额外的冲洗。在一些实施例中,额外的冲洗可以在导管15插入失败之后。
在一些实施例中,致动器26可以包括空心钉,所述空心钉可以促进阻隔件24的突破。在其他实施例中,致动器26可以是钝的。在一些实施例中,阻隔件24可以包括膜,如例如图2A至图2B所示。在一些实施例中,膜可以是疏水的。在一些实施例中,阻隔件24可以包括隔膜或另一种合适的阻隔元件。
在一些实施例中,流体存储单元20可以预附接到导管组件和/或预填充有流体18,以使得避免可能增加污染的风险的流体存储单元20与导管组件的连接或断开。在一些实施例中,导管系统10可以包括在套件中,所述套件可以包括预附接到导管组件并且预填充有流体18的流体存储单元20。在一些实施例中,与例如经由IV滴注器或预填充注射器进行灌注相反,经由流体存储单元20对导管组件的灌注可以促进患者在导管插入之后的活动性和/或临床医生在导管插入期间的灵活性。
现在参考图3A,在一些实施例中,导管毂12可以包括隔膜36和/或隔膜壳体38。可设想,隔膜36可以包括任何数量类型的隔膜,并且可以相对于导管毂12定位在各个位置处。在一些实施例中,隔膜36可以设置在导管毂12的内腔40内。在一些实施例中,隔膜36可以至少部分地设置在隔膜壳体38内,并且被配置成至少基本上密封导管毂12的内腔40。在一些实施例中,隔膜壳体38可以防止隔膜36的变位或不稳定,从而防止流体从导管毂12的内腔泄漏。
在这些和其他实施例中,导管毂12的内腔40可以包括第一内腔40a和/或第二内腔40b。在一些实施例中,导管毂12的近端可以形成第一内腔40a并且/或者侧端口14可以形成第二内腔40b。在一些实施例中,第一内腔和第二内腔40a、40b可以在公共内腔40c处接合。在一些实施例中,第一内腔40a可以与公共内腔40c大致对准。在一些实施例中,隔膜36和/或隔膜壳体38可以设置在第一内腔24中。
在一些实施例中,导管毂12的第二内腔40b可以经由可以从导管毂12的侧端口14延伸的延伸管16与流体存储单元20联接。在一些实施例中,延伸管16可以从导管毂12的近端或导管组件的另一端口延伸。在一些实施例中,延伸管16可以包括夹具。
现在参考图3B,在一些实施例中,在将导管15插入患者的脉管系统中之后,可以将导管组件的引导针42通过导管毂12抽出。在封闭IV导管组件中,当将引导针通过导管毂12抽出时,可以对应于“针通道”的第一内腔24可以通过隔膜与导管毂12周围的外部环境隔绝。因此,隔膜可以至少基本上密封导管毂12的近端,并且防止流体通过导管毂12的近端离开导管毂12。在一些实施例中,在流体灌注和/或输注期间,导管组件14的流体路径可以延伸通过侧端口14而不通过导管毂12的近端。
在一些实施例中,灌注导管组件的方法100可以从框102开始。在框102处,可以提供导管系统。在一些实施例中,导管系统可以包括以下中的一个或多个:导管毂、导管、延伸管、适配器、流体存储室和流体。在一些实施例中,流体存储室可以包括以下中的一个或多个:致动器、阻隔件和贮存器。在一些实施例中,导管系统、导管毂、导管、延伸管、适配器、流体存储室和流体可以包括或对应于关于前述图1至图3中的任一个分别描述的导管系统10、导管毂12、导管15、延伸管16、适配器18、流体存储室20和流体28。在一些实施例中,框102之后可以是框104。
在框104处,阻隔件可以用致动器突破,以使得贮存器与导管毂的内腔流体连通。框104之后可以是框106。
在框106处,可以挤压流体存储单元,以使得流体从贮存器流入导管毂的内腔中。在一些实施例中,流体存储器可以被临床医生挤压。在一些实施例中,用致动器突破阻隔件包括使流体存储单元的近侧部分和流体存储单元的远端更靠近在一起。在一些实施例中,在导管组件的灌注之后,可以将流体存储单元从导管组件移除。
尽管示出为离散的框,但是根据期望的实现方式,各种框可以被划分为附加的框,被组合为更少的框或被消除。例如,可以消除框106。在一些实施例中,响应于阻隔件的突破,流体可以流出流体存储单元并通过导管组件,从而灌注导管组件。
本文中所叙述的所有示例和条件语言都旨在用于教学目的以帮助读者理解本发明和发明人为促进本领域所贡献的理念,并且将被解释为不限于此类具体叙述的示例和条件。尽管已详细描述了本发明的实现方式,但是应理解,在不脱离本发明的精神和范围的情况下,可以对其进行各种改变、替换和变更。

Claims (15)

1.一种导管系统,所述导管系统包括:
导管组件,所述导管组件包括:
导管毂,所述导管毂具有远端、近端、在所述远端与所述近端之间延伸的内腔、以及侧端口;
导管,所述导管从所述导管毂的所述远端向远侧延伸;
延伸管,所述延伸管具有远端和近端,其中所述延伸管的所述远端联接到所述侧端口;以及
适配器,所述适配器联接到所述延伸管的所述近端;
流体存储单元,其中所述流体存储单元包括贮存器、阻隔件以及致动器,其中所述流体存储单元在所述阻隔件被突破之前便联接到所述适配器,其中所述流体存储单元的远端包括鲁尔适配器,其中响应于使所述流体存储单元的近侧部分和所述流体存储单元的远端更靠近在一起,所述阻隔件被所述致动器突破并且所述致动器延伸到所述贮存器中,以提供所述贮存器与所述导管毂的所述内腔之间的流体连通;以及
设置在所述贮存器内的导管灌注流体,其中响应于所述致动器对所述阻隔件的突破、和所述流体存储单元的挤压,所述导管灌注流体从所述贮存器流入所述导管毂的所述内腔中。
2.根据权利要求1所述的导管系统,其中所述适配器包括Y形适配器。
3.根据权利要求1所述的导管系统,其中所述致动器包括空心钉。
4.根据权利要求1所述的导管系统,其中所述阻隔件包括隔膜。
5.根据权利要求1所述的导管系统,其中所述阻隔件包括膜。
6.根据权利要求5所述的导管系统,其中所述膜是疏水的。
7.根据权利要求1所述的导管系统,其中所述流体存储单元能够朝向所述流体存储单元的与所述致动器对准的轴线压缩。
8.根据权利要求1所述的导管系统,其中所述流体存储单元能够朝向所述流体存储单元的与所述致动器垂直的轴线压缩。
9.一种方法,包括:
提供导管系统,所述导管系统包括:
导管组件,所述导管组件包括:
导管毂,所述导管毂具有远端、近端、在所述远端与所述近端之间延伸的内腔、以及侧端口;
导管,所述导管从所述导管毂的所述远端向远侧延伸;
延伸管,所述延伸管具有远端和近端,其中所述延伸管的所述远端联接到所述侧端口;以及
适配器,所述适配器联接到所述延伸管的所述近端;
流体存储单元,其中所述流体存储单元包括贮存器、阻隔件以及致动器,其中所述流体存储单元在所述阻隔件被突破之前便联接到所述适配器,其中所述流体存储单元的远端包括鲁尔适配器;以及
设置在所述贮存器内的导管灌注流体;
通过使所述流体存储单元的近侧部分和所述流体存储单元的远端移动更靠近在一起使得所述阻隔件被所述致动器突破并且所述致动器延伸到所述贮存器中,提供所述贮存器与所述导管毂的所述内腔之间的流体连通;以及
挤压所述流体存储单元,以使得所述导管灌注流体从所述贮存器流入所述导管毂的所述内腔中。
10.根据权利要求9所述的方法,其中所述致动器包括空心钉。
11.根据权利要求9所述的方法,其中所述适配器包括第一端口和第二端口,其中所述延伸管的所述近端联接到所述第一端口,所述方法还包括将所述第二端口联接到静脉注射液袋。
12.根据权利要求9所述的方法,其中所述阻隔件包括隔膜。
13.根据权利要求9所述的方法,其中所述阻隔件包括膜。
14.根据权利要求9所述的方法,其中所述流体存储单元能够朝向所述流体存储单元的与所述致动器对准的轴线压缩。
15.根据权利要求9所述的方法,其中所述流体存储单元能够朝向所述流体存储单元的与所述致动器垂直的轴线压缩。
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