CN103170050A - 包括三个内腔末端的导管组件 - Google Patents

包括三个内腔末端的导管组件 Download PDF

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CN103170050A
CN103170050A CN2013100731248A CN201310073124A CN103170050A CN 103170050 A CN103170050 A CN 103170050A CN 2013100731248 A CN2013100731248 A CN 2013100731248A CN 201310073124 A CN201310073124 A CN 201310073124A CN 103170050 A CN103170050 A CN 103170050A
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transverse opening
distal end
catheter body
tube component
conduit tube
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CN103170050B (zh
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R·T·莫尔
W·R·巴伦
S·W·桑德斯
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CR Bard Inc
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    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M25/007Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
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    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621Extra-corporeal blood circuits
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    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621Extra-corporeal blood circuits
    • A61M1/3653Interfaces between patient blood circulation and extra-corporal blood circuit
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    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621Extra-corporeal blood circuits
    • A61M1/3653Interfaces between patient blood circulation and extra-corporal blood circuit
    • A61M1/3659Cannulae pertaining to extracorporeal circulation
    • A61M1/3661Cannulae pertaining to extracorporeal circulation for haemodialysis
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    • A61M25/00Catheters; Hollow probes
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026Multi-lumen catheters with stationary elements
    • A61M25/003Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M25/00Catheters; Hollow probes
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026Multi-lumen catheters with stationary elements
    • A61M25/0032Multi-lumen catheters with stationary elements characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
    • AHUMAN NECESSITIES
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    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • AHUMAN NECESSITIES
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    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M25/0071Multiple separate lumens
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M25/00Catheters; Hollow probes
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026Multi-lumen catheters with stationary elements
    • A61M25/003Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves
    • A61M2025/0031Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
    • AHUMAN NECESSITIES
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    • A61M25/00Catheters; Hollow probes
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026Multi-lumen catheters with stationary elements
    • A61M2025/0037Multi-lumen catheters with stationary elements characterized by lumina being arranged side-by-side
    • AHUMAN NECESSITIES
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    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M2025/0073Tip designed for influencing the flow or the flow velocity of the fluid, e.g. inserts for twisted or vortex flow
    • AHUMAN NECESSITIES
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    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/008Strength or flexibility characteristics of the catheter tip
    • A61M2025/0081Soft tip
    • AHUMAN NECESSITIES
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    • A61MDEVICES 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
    • A61M2202/00Special media to be introduced, removed or treated
    • A61M2202/0021Special media to be introduced, removed or treated removed from and reintroduced into the body, e.g. after treatment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M25/0069Tip not integral with tube

Abstract

公开了在肾脏替换或其他疗法期间用来进入患者脉管系统的导管组件。所述导管组件包括导管本体,所述导管本体限定第一和第二内腔。所述导管本体限定远侧末端区域,所述远侧末端区域包括静脉横向开口,所述静脉横向开口与所述第一内腔流体连通并且包括面对远侧的部分。所述远侧末端区域还包括动脉横向开口,所述动脉横向开口与所述第二内腔流体连通,包括面对远侧的部分,并且相对于所述静脉横向开口基本上为非交错的。远侧端开口被限定在所述远侧末端区域上并且被选择尺寸以使流体通过其中。在一个实施方案中,所述远侧端开口与所述导管本体的第三内腔流体连通,所述第三内腔可以耐受与对比剂的高压注射相关联的高流体流率。

Description

包括三个内腔末端的导管组件
本申请是2008年10月31日递交的PCT国际申请PCT/US2008/082106于2010年6月30日进入中国国家阶段的中国专利申请号为200880123533.1、发明名称为“包括三个内腔末端的导管组件”的发明专利申请的分案申请。
对相关申请的交叉引用
本申请要求下述申请的优先权:2008年10月31日提交的题目为“包括三个内腔末端的导管组件(Catheter Assembly Including Triple Lumen Tip)”的美国专利申请No.12/262,820,以及2007年11月1日提交的题目为“包括三个内腔末端的导管组件(Catheter Assembly Including Triple Lumen Tip)”的美国临时专利申请No.60/984,661,本文通过引用将每一个的全部内容并入本申请。
发明内容
简要概述,本发明的实施方案涉及在肾脏替换或其他适合的疗法期间用来进入患者脉管系统或其他脉管的导管组件。在一个实施方案中,所述导管组件包括导管本体,所述导管本体限定第一和第二内腔。所述导管本体限定远侧末端区域,所述远侧末端区域包括至少一个静脉横向开口和至少一个动脉横向开口,所述至少一个静脉横向开口与所述第一内腔流体连通并且包括面对远侧的(distal-facing)部分,所述至少一个动脉横向开口与所述第二内腔流体连通并且包括面对远侧的部分。所述至少一个动脉横向开口相对于所述至少一个静脉横向开口以基本上非交错结构的方式被相对地设置。远侧端开口被限定在所述远侧末端区域上并且被选择尺寸以使流体通过其中。在一个实施方案中,所述远侧端开口与所述导管本体的第三内腔流体连通,所述第三内腔可以耐受(例如,与对比剂的高压注射(power injection)相关联的)高流体流率。
本发明的一种导管组件,包括:导管本体,所述导管本体限定至少一第一内腔和第二内腔,所述导管本体包括远侧末端区域,所述远侧末端区域包括:至少一个与所述第一内腔流体连通的静脉横向开口,所述至少一个静脉横向开口包括面对远侧的部分;至少一个与所述第二内腔流体连通的动脉横向开口,所述至少一个动脉横向开口包括面对远侧的部分,所述至少一个动脉横向开口相对于所述至少一个静脉横向开口以大致非交错结构的方式被相对地设置;以及远侧端开口,所述远侧端开口被选择尺寸以使流体从所述远侧端开口通过。
其中,所述至少一个静脉横向开口和所述至少一个动脉横向开口相对于彼此被对称地设置。
其中,所述远侧端开口与由所述导管本体限定的第三内腔连通。
其中,所述远侧端开口与所述第一内腔连通。
其中,可以经由一导丝槽自所述第一内腔穿过所述远侧端开口而通过一导丝,所述导丝槽与所述第一内腔和所述远侧端开口两者连通。
其中,所述至少一个静脉横向开口和所述至少一个动脉横向开口由通过所述导管本体外周的一成角度的横向切口限定。
其中,所述第一和第二内腔限定圆形截面形状,其中所述远侧端开口与由所述导管本体限定的第三内腔流体连通,所述第三内腔限定圆形截面形状,并且其中所述导管本体的外周限定一长圆形截面形状。
其中,所述第三内腔可以耐受从所述第三内腔穿过的在约3毫升/秒和约8毫升/秒之间的流率。
其中,所述至少一个静脉横向开口和所述至少一个动脉横向开口提供在正流动方向上和在反流动方向上基本上相等的再循环率。
其中,所述远侧末端区域还限定锥形鼻状部分,所述至少一个静脉横向开口和所述至少一个动脉横向开口两者的一部分被限定在所述鼻状部分上,所述远侧端开口被限定在所述鼻状部分的远侧端。
其中,所述远侧端开口被限定在所述鼻状部分的中心。
其中,所述鼻状部分包括相对于限定所述导管本体的材料具有低硬度的材料。
其中,所述导管本体包括具有肖氏硬度D约为60的材料,并且其中所述鼻状部分包括具有肖氏硬度A约为85的材料。
其中,所述鼻状部分包括基于聚氨酯的树脂。
本发明的一种通过导管组件处理患者血液的方法,所述方法包括:a)通过被限定在所述导管组件的第一内腔中的第一开口从患者体内抽吸血液;b)在患者体外处理血液;c)通过被限定在所述导管组件的第二内腔中的第二开口将处理过的血液注入患者体内;d)通过所述导管组件的第三内腔注入流体;以及e)使血流在所述第一和第二内腔内反向,从而通过所述第一内腔注入血液并且通过所述第二内腔抽吸血液,血流反向后的再循环率小于或等于约百分之五。
其中,注入所述流体还包括:通过所述第三内腔注入所述流体,以使得所述流体经由从所述第一和第二开口向远侧被限定的远侧端开口离开所述导管组件。
其中,在a-c阶段中处理过的血液的再循环率小于或等于百分之五。
其中,注入所述流体还包括:以在约3毫升/秒和约8毫升/秒之间的流率通过所述第三内腔注入所述流体。
其中,注入所述流体还包括:以在约50磅/平方英寸和约250磅/平方英寸之间的流体压力通过所述第三内腔注入所述流体。
本发明的一种导管组件,包括:导管本体,所述导管本体限定第一内腔、第二内腔以及第三内腔,所述导管本体包括远侧末端区域,所述远侧末端区域包括:锥形鼻状部分;静脉横向开口,所述静脉横向开口与所述第一内腔流体连通并且被限定在所述鼻状部分的一部分上,从而限定面对远侧的部分;动脉横向开口,所述动脉横向开口与所述第二内腔流体连通并且被限定在所述鼻状部分的一部分上,从而限定面对远侧的部分,所述静脉横向开口和动脉横向开口相对于彼此以基本上非交错位置的方式被对称地相反设置;以及被限定在所述鼻状部分的远侧端上的远侧端开口,所述远侧端开口与所述第三内腔流体连通。
其中,所述第三内腔可以耐受从所述第三内腔穿过的在约3毫升/秒和约8毫升/秒之间的流率以及在约50磅/平方英寸和约250磅/平方英寸之间的流体压力。
其中,所述静脉横向开口和动脉横向开口被这样成形,从而赋予从所述静脉横向开口和动脉横向开口流出的流体横向和向远侧的方向。
其中,所述鼻状部分被接合到所述导管组件的远侧端,所述鼻状部分包括具有相对于所述导管本体的硬度更低的硬度的材料。
其中,所述鼻状部分通过RF熔合被接合到所述导管本体的所述远侧端。
其中,所述静脉横向开口和动脉横向开口由成角度的横向切口限定。
其中,所述静脉横向开口和动脉横向开口绕所述组件本体的圆周的至少一部分被限定,从而防止脉管壁吸住。
其中,在当所述远侧末端区域抵靠脉管壁放置时的导管组件操作期间,所述静脉横向开口和动脉横向开口的所述面对远侧的部分提供流体的远侧流动。
其中,所述静脉横向开口和动脉横向开口由限定8字形形状的外周限定。
其中,经由所述静脉横向开口被注入的流体通过所述动脉横向开口的再循环率为小于或等于约百分之五。
其中,所述的导管组件还包括:与所述导管本体的所述第一内腔流体连通的第一预先弯曲的延伸腿;以及与所述导管本体的所述第二内腔流体连通的第二预先弯曲的延伸腿。
其中,在所述导管被插入患者的脉管系统中时,所述静脉段和所述动脉段两者可以用于血液抽吸和血液注入。
其中,当被插入到患者的脉管系统中时:在第一操作结构状态,血液经由所述动脉横向开口从脉管系统抽吸,并且血液经由所述静脉远侧开口注入所述脉管系统;并且在第二操作结构状态,血液经由所述静脉横向开口从脉管系统抽吸,并且血液经由所述动脉远侧开口注入所述脉管系统。
其中,所述静脉横向开口和动脉横向开口被这样限定,以至每一个横向开口的长轴限定一相对于所述导管本体纵轴的锐角,从而赋予自所述横向开口的流体流出横向和向远侧的流动方向。
在另一实施方案中,公开了导管组件包括导管本体,所述导管本体限定第一内腔和第二内腔。所述导管本体包括远侧末端区域,所述远侧末端区域又包括限定向远侧缩小的外表面的鼻状部分。与所述第一内腔流体连通的静脉横向开口被部分地限定在所述向远侧缩小的外径上。与所述第二内腔流体连通的动脉横向开口同样被部分地限定在所述向远侧缩小的外径上。所述静脉横向开口和动脉横向开口相对于彼此以基本上非交错位置的方式被对称地设置。所述远侧末端区域还包括与所述静脉内腔和动脉内腔中的一个流体连通并被选择尺寸以使导丝穿过其中的远侧端开口。
本发明的一种导管组件,包括:导管本体,所述导管本体限定第一内腔和第二内腔,所述导管本体包括远侧末端区域,所述远侧末端区域包括:鼻状部分,所述鼻状部分限定向远侧缩小的外表面;与所述第一内腔流体连通的静脉横向开口,所述静脉横向开口被至少部分地限定在所述向远侧缩小的外径上;与所述第二内腔流体连通的动脉横向开口,所述动脉横向开口被至少部分地限定在所述向远侧缩小的外径上,所述静脉横向开口和动脉横向开口相对于彼此以基本上非交错位置的方式被对称地设置;以及远侧端开口,所述远侧端开口与所述静脉内腔和动脉内腔中的一个流体连通并且被选择尺寸以使导丝穿过所述远侧端开口。
其中,所述静脉横向开口和动脉横向开口中的每一个包括面对远侧的部分。
其中,导丝槽提供在所述远侧端开口和所述第一和第二内腔中的各自一个之间的流体连通。
其中,所述远侧端开口与所述第一内腔流体连通并且其中所述导丝槽和所述远侧端开口与所述第一内腔轴向对准。
其中,流体是可通过的,即从所述第一内腔到经由所述远侧端开口离开。
其中,所述静脉横向开口和动脉横向开口中的每一个的一部分进一步地被限定在所述远侧末端区域的终端导管部分,所述终端导管部分邻近所述鼻状部分。
其中,所述鼻状部分限定子弹形状和锥形形状中的一种。
其中,所述导管本体限定长圆形截面形状并且其中所述导管本体的外壁在所述外壁相对的侧上是加厚的。
本发明的这些和其他特征将从下面的说明和所附的权利要求书中变得更加完整清晰,或者可以通过对由下文所阐明的本发明的实践来获悉。
附图说明
为进一步阐释本发明的上述和其他优点和特征,将通过参考本发明的具体的实施方案提供对本发明的更加具体的描述,所述的具体实施方案在所附的附图中被图示说明。可以理解,这些附图仅描绘本发明的典型实施方案,因而不能被认为是对本发明范围的限制。将通过使用说明书附图来以附加的特征和细节对本发明进行描述和解释,其中:
图1为结合了本发明的实施方案的各种特征的导管组件的透视图;
图1A为根据一个实施方案配置的导管组件的另一实施例的透视图;
图2为根据一个实施方案配置的,如图1所示的所述导管组件的远侧末端区域的透视图;
图3为图2的所述导管远侧末端区域的侧视图;
图4为图2的所述导管远侧末端区域的顶视图;
图5为图2的所述导管远侧末端区域的端视图;
图6为图2的所述导管远侧末端区域的透视图,描绘被限定在其中的横向开口的各种细节;
图7A为图2的所述导管组件和远侧末端区域的剖视图,示出以“正”流动结构穿过其中的血流;
图7B为图2的所述导管组件和远侧末端区域的剖视图,示出以“反”流动结构穿过其中的血流;
图8A为沿图4中的线8A—8A得到的所述导管组件的剖视图;
图8B为沿图4中的线8B—8B得到的所述导管末端的另一剖视图;
图8C为沿图4中的线8C—8C得到的所述导管末端的又另一剖视图;
图8D为根据一个实施方案的所述导管组件的远侧末端区域的又另一剖视图,示出其第三内腔的设置;
图9A-9F描绘根据一个实施方案配置的包括远侧末端区域的导管组件的各种视图;
图10A-10D分别为根据一个实施方案配置的包括远侧末端区域的导管的透视图、前视图、侧视图以及顶视图。
图11A-11D分别为根据一个实施方案配置的包括远侧末端区域的导管的透视图、前视图、侧视图以及顶视图。
图12A-12D分别为根据一个实施方案配置的包括远侧末端区域的导管的透视图、前视图、侧视图以及顶视图。
图13A-13D分别为根据一个实施方案配置的包括远侧末端区域的导管的透视图、前视图、侧视图以及顶视图。
图14A-14D分别为根据一个实施方案配置的包括远侧末端区域的导管的透视图、前视图、侧视图以及顶视图。
图15A-15D分别为根据一个实施方案配置的包括远侧末端区域的导管的透视图、前视图、侧视图以及顶视图。
图16A-16D分别为根据一个实施方案配置的包括远侧末端区域的导管的透视图、前视图、侧视图以及顶视图。
图17A-17D分别为根据一个实施方案配置的包括远侧末端区域的导管的透视图、前视图、侧视图以及顶视图。
图18A-18D分别为根据一个实施方案配置的包括远侧末端区域的导管的透视图、前视图、侧视图以及顶视图。
图19A-19D分别为根据一个实施方案配置的包括远侧末端区域的导管的透视图、前视图、侧视图以及顶视图。
图20A-20D分别为根据一个实施方案配置的包括远侧末端区域的导管的透视图、前视图、侧视图以及顶视图。
具体实施方式
现在将参考附图,其中相似的结构将被提供以相似的参考编号。可以理解,附图为示例性实施方案的图解的和示意的表征,而非对所述实施方案的限制,所述附图也无须按比例绘制。
图1-20D描绘本发明的实施方案的各种特征,一般地涉及在肾脏替换疗法(例如血液透析或血液净化)期间,用来进入患者脉管系统或其他血管的尖锐的(acute)导管组件,然而本发明的原理可以延伸到在除这些以外的其他应用中所用到的其他导管。这样的尖锐导管典型地被用在短期放置方案中,例如少于30日的放置,然而本文将描述的原理还可以应用于中期和长期导管放置。
根据一个示例性实施方案,所述导管组件包括限定分开的静脉横向开口和动脉横向开口的远侧末端区域,所述横向开口与相对应的静脉内腔和动脉内腔流体连通,在血液透析处理期间,所述相对应的静脉内腔和动脉内腔被用来从患者脉管系统的静脉或其他脉管同时注入和抽吸血液。所述静脉横向开口和动脉横向开口相对于彼此以基本上等同的非交错位置的方式被设置,从而使其能够设置在脉管系统的预先确定的区域内。然而,所述横向开口被配置来降低刚刚通过所述静脉段送回脉管的处理过的血液被所述动脉段再循环的可能性,从而提高导管效率。此外,在血液透析期间,所述横向开口可以以反向流动结构来操作而不显著地影响导管效率。
本文将描述的所述导管组件的实施方案还包括与所述导管的一内腔流体连通的远侧端开口,所述内腔被这样配置以耐受相对高的压力以及典型地与高压注射相关联的流率。这使流体的抽吸或注入能够经由这一独立于所述静脉内腔和动脉内腔的内腔实现。“高压注射”在本文被限定为包括在相对高的流率和/或相对高的压力下的流体注入。例如,在一个实施方案中,高压注射包括以在约3毫升/秒和约8毫升/秒之间的流率和/或在约50磅/平方英寸(psi)和约250磅/平方英寸之间的压力通过导管内腔的流体注入。
为清楚起见,将理解到的是,词语“近侧的(proximal)”涉及相对地更靠近使用本文将描述的所述设备的临床医生的方向,而词语“远侧的(distal)”涉及相对地更远离临床医生的方向。例如,被放置在患者体内的导管的端被认为是所述导管的远侧端,而所述导管仍保留在体外的端为所述导管的近侧端。另外,如本文(包括权利要求书)所使用的词语“包括(including)”、“具有(has)”以及“具有(having)”,应当具有同词语“包括(comprising)”相同的意思。
首先参考图1,描绘根据一个示例性实施方案的血液透析导管组件(一般地被标明为10)的各种特征。如所示的,导管10包括细长的导管本体11,导管本体11包括近侧端11A和远侧端11B。细长的导管本体11限定从近侧端11A纵向延伸至其远侧端11B的第一内腔12、第二内腔14以及第三内腔15(图7A)。所述内腔12、14以及15可以沿其各自的长度具有一个或更多个截面形状,包括圆形、椭圆形、D截面形状或其任何组合。在一个实施方案中,第一和第二内腔12、14被选择尺寸,从而适应在约250毫米汞柱的压力下血液透析所需的流体流率,即约300毫升/分钟。在一个实施方案中,所述第三内腔被选择尺寸具有约0.035英寸至约0.038英寸的直径,以适应血液抽取和流体抽吸/注入穿过其中。
三叉套(hub)20被包括在导管本体近侧端11A,分别提供第一、第二以及第三内腔12、14、15与动脉延伸腿16、静脉延伸腿18以及加强延伸腿(power extension leg)19之间的流体连通。延伸腿16、18、19的每一个包括鲁尔连接器(luer connector)16A、18A、19A和夹子16B、18B、19B。如这样配置,延伸腿16、18提供与第一和第二内腔12和14的流体连通,从而使流体能够注入患者的中心静脉系统或从患者的中心静脉系统抽吸。这样,流体注入或抽吸设备,例如血液透析装置,可以经由鲁尔连接器16A、18A被连接到导管组件10,从而提供对患者血管内的进入。类似地,延伸腿19提供与第三内腔15的流体连通,以在当相对应的设备经由连接器19A与延伸腿19连接时,使流体能够注入静脉/从静脉抽吸。请注意,在此详述的所述延伸腿各自的位置和结构可以根据具体的导管组件设计而改变,因而不应被视为是限制性的。导管本体11还包括用于提供将所述导管本体固定到患者的缝合翼(suture wing)21。
图2示出根据另一示例性实施方案的导管组件10,其中延伸腿16、18每个包括预先弯曲的部分16C、18C。一旦所述导管组件的所述远侧部分已经被放置在脉管系统中,预先弯曲的部分16C、18C使导管组件10的延伸腿16、18能够抵着患者的身体向下延伸,以使患者舒适。
更具体地,图1和2的加强延伸腿19以流体连通方式(fluidly)经由三叉套20连接到第三内腔15。特别地,在一个实施方案中,加强延伸腿19被这样配置以使得用于对比增强CT(contrast-enhanced CT)扫描成像的对比剂(contrast media)的快速注入(即高压注射),或经由第三内腔15进入患者脉管的其他流体的快速注入能够进行。具体地,在一个实施方式中,加强延伸腿19和第三内腔15被这样配置,从而以在约3毫升/秒和约8毫升/秒之间的速率和在约50磅/平方英寸和250磅/平方英寸之间的流体压力注入流体,然而其他流率和流体压力也可以是可能的。加强延伸腿19和第三内腔15也可以单独或在第一和第二内腔12和14的同时使用期间被用于移出血液或其他流体,并且借助于换能器监控中心静脉压力。加强延伸腿19和第三内腔15还被充分地选择尺寸,以接纳导丝穿过其中来使所述导管组件能够在所述导丝上插入。请注意,在一个实施方案中,加强延伸腿19的部件被赋予紫色,以表明高压注射能力。也可以使用其他颜色。
图1和2两者还包括根据本发明的一个示例性实施方案配置的远侧末端区域(一般地被标明为50),下面给出其细节。应当理解的是,将在下面描述的所述远侧末端区域可以被包括于血液透析导管(例如在图1和2中所示出的导管)或其他导管(例如中心静脉导管)。的确,根据本发明的实施方案的所述导管组件可以被调整以在其他应用中使用,例如慢性透析治疗或进入脉管是期望获得的部位,例如内颈静脉、锁骨下动(静)脉或股脉管,再或是患者的其他身体内腔。这样的其他应用的实施例包括血液分离(apheresis)、血浆灌流等等。
现在参考图2-6,示出被一般地标明为50并且根据一个示例性实施方案配置的导管组件10的远侧末端区域的各种视图。具体地,远侧末端区域50一般地包括终端导管部分50A和从所述终端导管部分向远侧设置的鼻状部分50B,以限定导管组件10的远侧端。终端导管部分50A作为导管本体11的更近侧部分的一部分,由表现出各种品质的适合的材料构成,例如适度柔软性以允许易于插入而不会引起脉管创伤,以及生物相容性以使所述导管能够如所期望地操作。在一个实施方案中,构成导管本体11的材料包括:基于热塑性聚氨酯的树脂材料,特别是以商标TECOFLEX出售的基于聚醚的脂族热塑性聚氨酯,即具有约为60的肖氏硬度D(Shore D)的TECOFLEX EG-60D-B20,其中“B20”涉及放射镇静剂负荷(radiopacifier loading),即20%的硫酸钡负荷。也可以使用其他适合的材料。
相反,鼻状部分50B包括相对于终端导管部分50A的材料更柔软的材料,从而防止在进入脉管或通行(transit)期间所述末端部分对脉管或其他脉管系统造成损坏。在一个实施方案中,鼻状部分50B由包括具有约85的肖氏硬度A(Shore A)的TECOFLEXEG-85A-B20的材料构成。尽管进行了上述描述,应当理解的是,如本文所描述的和如本领域技术人员所了解的,所述终端导管部分和所述鼻状部分可以包括其他具有期望性质的材料。可以用于所述终端导管部分和所述鼻状部分的材料的一个非限制性实施例是硅树脂(silicone)。
请注意,在图示说明的实施方案中,鼻状部分50B在导管组件10的制造期间经由模塑工艺被接合到终端导管部分50A。然而,在其他实施方案中,可以使用其他工艺来将所述鼻状部分接合到所述导管本体,包括:例如RF熔合(RF末端成形(tipping)),经由粘合剂结合,将所述鼻状部分和所述导管本体一体成形等等。
如在图3和4中最佳地可见的,鼻状部分50B是向远侧缩小的。在所述本实施方案中,鼻状部分50B是锥形的,从而易于导管本体11的远侧部分的进入和穿入到患者的脉管系统或其他内部的腔中。鼻状部分50B可以被赋予不同于导管本体11其余部分的颜色,以表明导管组件10可以被用于经由第三内腔15和相对应的加强延伸腿19而进行的相对快速的流体抽吸和注入,如上面已进一步描述的那样。
远侧末端区域50包括当导管组件10被放置以在患者脉管系统中使用时用来使流体能够注入和抽吸的各种开口。具体地,并根据一个实施方案,所述远侧末端区域包括静脉横向开口60、动脉横向开口62以及远侧端开口64。
更具体地,静脉横向开口和动脉横向开口60和62在邻近导管本体远侧端11B处被彼此相对设置,并被限定在导管本体11的外壁的一横向部分中,从而分别与第一内腔12和第二内腔14流体连通,因而当导管组件10被放置在患者的脉管系统中时,使血液或其他流体能够经由所述开口流到所述内腔/经由所述开口来自所述内腔。如在图4中最佳地可见的和下面进一步描述的,静脉横向开口和动脉横向开口60和62分别由外周60A和62A限定。
请注意,横向开口60和62中的每一个从终端导管部分50A向远侧延伸到鼻状部分50B。当然,横向开口60和62沿导管本体11的纵向长度的确切放置位置可以根据特定应用的需要而变化。
图4示出,在本实施方案中静脉横向开口和动脉横向开口60和62是基本上非交错的,即沿导管本体11的纵向长度相对于彼此是等同设置的,以致每一个基本上是以与远侧导管端11B相等的距离被设置的。横向开口60和62这样的非交错设置使两个开口能够在脉管系统中邻近期望的位置被放置,并且不管流入/流出所述横向开口的血液各自的方向确保已经处理过的血液通过导管组件10的再循环率被保持为相对恒定的。如果通过所述导管的血流方向需要为反向时,这一特征是有用的。在一个实施方案中,任一方向的再循环率均小于或等于约百分之五。在另一实施方案中,所述静脉横向开口和动脉横向开口可以是交错的。
图2-6还示出将静脉横向开口和动脉横向开口60和62限定在远侧末端区域50中的方式。如将在下面进一步示出的,横向开口60和62可以具有各种形状和结构,但在本实施方案中,所述横向开口由通过导管本体11外表面的成角度的横向钻孔(cross-drilled)的切口来限定,以建立与各自的第一或第二内腔12、14的连通。在一个实施方案中,这样的切口被称为“削割(skive)”的切口。
在一个实施方案中,横向开口60、62的每一个横向钻孔的切口的长轴限定与导管本体11的纵轴所成的约为35度(在一个实施方案中)的角θ1,然而在一个实施方案中,这一角度可以从约大于零度变化到约90度。如图4中的流动箭头所表征的,这一角度特性赋予从横向开口60、62中的流出的流体横向和向远侧的分量,这帮助使得从横向开口中的一个流出或流入的流体能够具有低的再循环。在本实施方案中,横向开口60和62的每一个均由相对于纵轴70具有相同的角θ1的完全一样的横向切口限定,然而一般也可以变化所述角度或针对每一个开口不同地变化所述角度。
在一个实施方案中,所述横向开口可以由复合角横向切口限定,其中每一个横向开口的长轴限定与所述导管本体纵轴以及与分隔所述第一内腔和所述第二内腔的平面所成的一角度,也即,所述平面与使邻近所述远侧末端区域的所述第一和第二内腔分开的隔膜共面。
图6描绘所述横向切口的端视图,示出在图示说明的实施方案中,设定开口60和62的每一个的所述横向切口,从而一般地限定经过远侧末端区域50的一外围部分的半圆形腔。如图6中所示的,这一腔由具有半径“R”的圆周72的一部分限定。在本实施方案中,限定横向开口60或62的所述横向切口,是通过使用柱状钻头或具有与圆周72的半径R相等的半径的取芯工具,并以设定的角θ1切割穿过远侧末端区域50而实现的。例如,在一个实施方案中,使用具有1/16英寸半径的钻头穿过限定长圆形(其中长径和短径的平均值约为0.173英寸)截面的导管本体来对角地横向切割静脉横向开口和动脉横向开口60和62。请注意,在一个实施方案中,所述导管本体的尺寸可以从7-16Fr.变化,然而其他的导管尺寸(French size)也是可能的。虽然是结合静脉横向开口60所示出的,上述描述也可以应用于动脉开口62。在此请注意,所述第一和第二开口在本实施方案中虽然是完全一样地被选择尺寸和成形,如果对特别的应用而言是期望的或是需要的,所述第一和第二开口可以分别具有不同的尺寸。
如刚刚所描述的,作为限定所述横向切口的结果,静脉横向开口和动脉横向开口60和62由上面所讨论的其各自的外周60A和62A来限定。设定所述横向切口的所述角度和导管本体11在所述切口处的形状,共同导致如在所述附图中所见的那样成形的外周60A和62A。如在图4中最佳地可见的,在本实施方案中,当以二维透视观看时,外周60A和62A的每一个限定8字形形状或8字曲线,并且在三维透视观看时为细长的鞍型形状。此外,因为每一个开口60和62的远侧部分被限定在锥形鼻状部分50B的一部分上(图4和5中最佳地可见),每一个开口具有面向远侧的部分(图5中最佳地可见),其中每一个横向开口的一部分是远侧可见的。
上面所描述的静脉横向开口和动脉横向开口60和62的结构给出了导管组件10的各个方面。首先,由于它们的鞍型形状,横向开口60和62部分地绕导管本体11的外周环绕延伸。因为所述开口的负流动压力被分布在所述导管本体圆周的一部分的周围,这有助于当所述开口中的一个从脉管中将血液移出时,防止远侧末端区域50被不期望的吸到脉管壁上。如果脉管吸住确实发生,横向开口60、62被这样成形,从而仍然提供可以接受的流入和流出导管组件10的流体。横向开口60和62相对大的尺寸也帮助防止堵塞或覆盖物形成(sheath formation),并且提供从中流出的流体的分散的(fanned-out)或大范围的分布。因此,改善再循环的有效率。
其次,每一个横向开口60和62的所述面向远侧的面帮助赋予被从中射出的流体一远侧方向。甚至当导管本体11抵靠脉管壁放置时,这使得所述被射出的流体能够从一个各自的横向开口向远侧流动离开,以及从远侧向近侧流入另一个横向开口。此外,横向开口60、62在彼此的方向上是对称地相反设置的,即如在图4中最佳地示出的180度的分开,从而确保流体进入和离开所述横向开口是发生在导管组件10的相反的侧上,进一步减少再循环。再者,如在图3中最佳地可见的,这一对称的设置在横向开口60和62之间产生“交叉(criss-cross)”关系,这帮助减少再循环。再有,如下面进一步讨论的,甚至是在流体流动穿过导管组件10是反向的时候,可以实现相似的流体流动特性。另外,本文所描述的所述横向开口结构使一旦经由横向开口60或62中的一个离开导管本体11的流体的剧烈变向最小化,这又防止了流体扰动和可能的凝块或溶血。
如在图2-6中所示的,远侧端开口64向远侧设置在远侧末端区域鼻状部分50的所述远侧端并且与第三内腔15流体连通,从而在使用导管期间使得能以高流率注入(即对比剂或其他流体(例如,TPN营养流体和药物)的高压注入)脉管和从脉管将血液移出。在对比剂或药物注入脉管的情况下,在第一和第二开口60和62远侧设置远侧端开口64有益地导致,如果注入在通过静脉开口和动脉开口60和62的流体通路同时发生时(例如,在血液透析或其他的治疗期间),对比剂/药物被吸入所述第一或第二开口中的一个的最小化。
请注意,在一个实施方案中,在患者脉管系统中最初的或调换导管放置期间,导丝可以通过远侧端开口64、第三内腔15以及加强延伸腿19被插入。同样请注意,三个开口60、62以及64在导管本体11的所述远侧部分中的相对近侧的设置使每一个开口可以在脉管系统中靠近期望的位置被放置,例如上腔静脉(“SVC”)。
现在参考图7A和7B,根据本实施方案描述关于导管组件10的远侧末端区域50的结构的流动特性。图7A和7B示出在导管组件10已经被适当地放置在患者的脉管中以后的远侧末端区域50。箭头84示出在患者的脉管中血流通过远侧末端区域50的方向。
更具体地,图7A示出流体以“正”方向流动穿过远侧末端区域50,其中血液由第二内腔14或“吸取(uptake)”内腔抽吸,以从身体移出并由血液透析装置处理或为了某个其他的适当目的。抽吸出的血液经由远侧末端区域50的动脉横向开口62进入第二内腔14。类似地,在由血液透析装置处理或某个其他的适当目的后,血液由第一内腔12或“送回”内腔被注入或被送回到脉管。注入的血液从静脉横向开口60离开第一内腔12。请注意,静脉横向开口和动脉横向开口60、62的横向定向提供了在脉管内的已被处理过的血液的低再循环,再循环被定义为经由所述静脉内腔被送回到血流中的已被处理过的血液立即被所述动脉段抽吸以进行再次处理。由于这导致更低的处理效率和更长的处理时间,这样的再循环是不期望的。
在血液透析过程期间,有时需要使通过导管组件10的血流反向。图7B示出在这样的“反”流动情况下,流体流动通过远侧末端区域50。和图7A的正流动情况形成对照,图7B中的第二内腔14被用来将血液注入脉管,而第一内腔12从脉管抽吸血液。在这一结构中,注入的血液经由动脉横向开口62进入脉管,而抽吸的血液经由静脉横向开口60被移出。再者,静脉横向开口和动脉横向开口60、62的所述横向定向提供在脉管内的已被处理过的血液的低再循环。因而,可以看到,不管所述导管在什么方向被操作,均导致低再循环。
图7A和7B进一步示出,在通过静脉横向开口和动脉横向开口60、62的注入/抽吸之前、之后或期间,流体可以经由与第三内腔15流体连通的远侧端开口64抽吸或注入。如所提到的,第三内腔15和远侧端开口64被这样配置,以致耐受进入脉管的相对高的加压流体流的注入。应当理解的是,在其他实施方案中,如果期望,多于一个的所述导管内腔可以被配置来用于高加压流体流的注入。
应当理解的是,如上面在对所述导管组件的各种部件的描述中所使用的称号(label)“静脉(venous)”和“动脉(arterial)”,是为了在描述本发明的实施方案的各个方面中的方便。的确且如刚刚所描述的,尽管所述动脉横向开口通常在血液透析过程中被用来从血管(所述导管被放置到其中的血管)中抽吸血液,而所述静脉横向开口用来将已被处理过的血液送回血管,但这可以被反向,以致血液经由所述动脉横向开口被送回而由所述静脉横向开口被抽吸。这样,本发明的实施方案应当不能被认为是受使用本文这样的或其他的描述性术语的限制。
现在参考图8A-8C,描绘了关于导管本体11的各种细节。具体地,图8A示出导管本体11在邻近远侧末端区域50处的剖视图,示出第一内腔12、第二内腔14以及第三内腔15。三个内腔12、14、15沿导管本体11的纵向长度被限定,并且以外周或壁86为边界。在本实施方案中,导管本体11的外壁86限定一长圆形状(oblong)并且包括与第一和第二内腔12、14相交且横跨所述导管本体宽度的横轴88。第一和第二内腔12、14彼此毗连的设置(其中在其下方设有第三内腔15)提供坚固的(robust)内腔结构,所述内腔结构抵抗由导管本体11的扭结所导致的内腔的非有意闭合。另外,导管本体11的所述长圆形的截面结构使圆形的截面形状能够用于内腔12、14和15,这相对于“D”形的或其他形状的内腔在流体流动方面更有效。
如在图8B中所见的并且如之前所描述的,静脉横向开口60被这样限定,以致其与第一内腔12相交,而动脉横向开口被这样限定,以致其与第二内腔14相交。这样,第一内腔12建立了在静脉延伸腿18和静脉横向开口60之间的流体连通,而第二内腔14建立了在动脉延伸腿16和动脉横向开口62之间的流体连通。在一个实施方案中,限定静脉开口和动脉开口60和62的所述成角度的横向切口相对于使第一和第二内腔12、14分开的隔膜90被相切地设定,以致在所述两个内腔之间作为屏障(barrier)的所述隔膜壁保持完好。
图8A-8C依次描绘所述第三内腔从靠近底部的中心位置沿导管本体11的长度上升到其在远侧端开口64的出口处的中心位置上(如图5所示)的方式。当然,其他的内腔位置结构也是可能的。
应当理解到,可以对上面所描述的所述导管组件结构进行各种修改。请注意,为清楚起见的目的,仅对在前述和下述实施方案之间所选出的不同之处进行描述。例如,图9A-9F描绘包括终端导管部分150A和鼻状部分150B的远侧末端区域150,终端导管部分150A与导管本体11一体成形,鼻状部分150B包括相对低的硬度(例如柔软)的材料并且以类似于已经在上面结合图2-6描述过的方式被接合到终端导管部分150A。
远侧末端区域150限定与第一内腔12流体连通的静脉横向开口160,以及与第二内腔14流体连通的动脉横向开口162。在鼻状部分150B的远侧端还限定有远侧端开口164。如在图9A-9F中所配置的导管组件为双内腔设备,其内部仅包括两个内腔12和14(图9E)。因此,如在图9F中最佳地可见的,远侧端开口164并不与第三内腔连通,而是与由鼻状部分150B限定的导丝槽164A连通,导丝槽164又与第一内腔12连通。以这种方式,通过导管本体11和远侧末端区域150建立导丝路径,以使在最初放置和导管调换过程期间,所述导管组件能够在导丝上被插入。
图9E描绘邻近远侧末端区域150的所述导管本体的剖视图。如所示的,导管本体11的外壁186的顶部和底部部分包括向所述导管本体提供附加的抗扭结性的加厚的区域186A。
凭借其与第一内腔12的连通,导丝槽164A经由远侧端开口164为所述第一内腔提供附加的流体出口/入口,因而提供在所述导管的操作期间进一步减少再循环的附加的流体路径。通过穿过其中的血流,这一流体连通还将导丝槽164A维持为张开的,从而防止其堵塞。另请注意,尽管是被定位在鼻状部分150B的所述远侧端的中心,静脉横向开口164可以被这样设置,以致其和相对应的导丝槽164A与第一内腔12是纵向成直线对准的。此外,所述静脉横向开口和所述相对应的导丝槽可以是被配置为与所述第二内腔连通的,或者,如果期望的话,与所述第一和第二内腔两者连通。
图10A-10D和11A-11D是根据本发明的示例性实施方案的双内腔导管组件的其他实施例。远侧末端区域250/350的每一个包括终端导管部分250A/350A和鼻状部分250B/350B,在远侧末端区域250/350限定有静脉横向开口260/360、动脉横向开口262/362以及远侧端开口264/364。导丝槽264A/364A被限定在远侧端开口264/364到第一内腔12之间,从而与其连通。如通过比较可见的,图10A-10D中的横向开口260、262被与图11A-11D中的相对应的横向开口360、362是不同地成形的。此外,鼻状部分250B(图10A)是以一锥形结构向远侧缩小的,然而鼻状部分350B(图11A)是以一成圆形的结构向远侧缩小以限定一子弹形。还请注意,如在图10B和11B中最佳地可见的,本文所描述的实施方案的所述双内腔的所述静脉横向开口和动脉横向开口包括面向远侧的部分,提供类似于上面结合关于图2-6的讨论所概括出的特性。
图12A-12D根据附加的示例性实施方案,描绘包括三个内腔的导管组件远侧末端区域的可能结构。由于其共用与上面结合图2-7B所描述的实施方案的各个方面,在下面将仅对所遵照的实施方案的所选出的方面进行讨论。
图12A-12D描绘包括终端导管部分450A和鼻状部分450B的导管组件远侧末端区域450。远侧末端区域450还包括与第一内腔12流体连通的静脉横向开口460,以及与第二内腔14流体连通的动脉横向开口462。鼻状部分450B的远侧端还限定有远侧端开口464。在本实施方案中,当以图12D的视角观看时,横向开口460和462的每一个限定梯形(trapezoidal)外周,并且是彼此对称地相反设置的。
图13A-13D描绘包括终端导管部分550A和鼻状部分550B的导管组件远侧末端区域550。远侧末端区域550还包括与第一内腔12流体连通的静脉横向开口560,以及与第二内腔14流体连通的动脉横向开口562。鼻状部分550B的远侧端还限定有远侧端开口564。在本实施方案中,当以图13D的视角观看时,横向开口460和462的每一个限定阶梯状外周,并且是彼此对称地相反设置的。
图14A-14D描绘包括终端导管部分650A和鼻状部分650B的导管组件远侧末端区域650。远侧末端区域650还包括与第一内腔12流体连通的静脉横向开口660,以及与第二内腔14流体连通的动脉横向开口662。鼻状部分650B的远侧端还限定有远侧端开口664并且远侧端开口664与导管本体11的中心轴是轴向偏置的。在本实施方案中,当以图12C的视角观看时,横向开口660和662的每一个限定椭圆形外周,并且如在图14D中最佳地可见的,横向开口660和662是彼此对称地相反设置的。
图15A-15D描绘包括终端导管部分750A和鼻状部分750B的导管组件远侧末端区域750。远侧末端区域750还包括与第一内腔12流体连通的静脉横向开口760,以及与第二内腔14流体连通的动脉横向开口762。鼻状部分750B的远侧端还限定有远侧端开口764并且远侧端开口764与导管本体11的中心轴是轴向偏置的。在本实施方案中,当以图15C的视角观看时,横向开口760和762的每一个限定椭圆形外周,并且如在图15D中最佳地可见的,横向开口760和762是彼此对称地相反设置的。
图16A-16D描绘导管组件远侧末端区域850,远侧末端区域850包括与第一内腔12流体连通的静脉横向开口860,以及与第二内腔14流体连通的动脉横向开口862。远侧末端区域850的远侧端还限定有远侧端开口864并且远侧端开口864与导管本体11的中心轴是轴向偏置的。在本实施方案中,横向开口860和862由隔膜890分开,并且当以图16C的视角观看时,每一个限定部分椭圆形外周,并且如在图16D中最佳地可见的,横向开口860和862是彼此对称地相反设置的。
图17A-17D描绘导管组件远侧末端区域950,远侧末端区域950包括与第一内腔12流体连通的静脉横向开口960,以及与第二内腔14流体连通的动脉横向开口962。远侧末端区域850的远侧端还限定有远侧端开口964并且远侧端开口964与导管本体11的中心轴是轴向偏置的。在本实施方案中,横向开口960和962由隔膜990分开,并且当以图16C的视角观看时,每一个与外导管本体壁986的一部分共同限定成锐角形状的外周。如前述,在图17D中最佳地可见的,横向开口960、962是彼此对称地相反设置的。
图18A-18D描绘包括终端导管部分1050A和鼻状部分1050B的导管组件远侧末端区域1050。远侧末端区域1050还包括与第一内腔12流体连通的静脉横向开口1060,以及与第二内腔14流体连通的动脉横向开口1062。远侧末端区域鼻状部分1050B的远侧端还限定有远侧端开口1064并且远侧端开口1064相对于导管本体11的中心轴是被设置在中心的。在本实施方案中,横向开口1060和1062由隔膜1090分开,并且当以图18C的视角观看时,每一个限定部分椭圆形外周。如前述,在图18D中最佳地可见的,横向开口1060、1062是彼此对称地相反设置的。
图19A-19D描绘包括鼻状部分1150B的导管组件远侧末端区域1150。远侧末端区域1150还包括与第一内腔12流体连通的静脉横向开口1160,以及与第二内腔14流体连通的动脉横向开口1162。鼻状部分1150的远侧端还限定有远侧端开口1164并且远侧端开口1164自导管本体11的中心轴是轴向偏置的。在本实施方案中,当以图19D的视角观看时,横向开口1160和1162的每一个限定三角形外周,并且如在图19D中最佳地可见的是彼此对称地相反设置的。
图20A-20D描绘包括终端导管部分1250A和鼻状部分1250B的导管组件远侧末端区域1250。远侧末端区域1250还包括与第一内腔12流体连通的静脉横向开口1260,以及与第二内腔14流体连通的动脉横向开口1262。鼻状部分1250B上还限定有远侧开口1264并且远侧开口1264与导管本体11的中心轴是轴向偏置的。在本实施方案中,横向开口1260和1262由隔膜1290分开,并且当以图20C的视角观看时,每一个限定截锥形(frustoconical)的外周。如前述,在图20D中最佳地可见的,横向开口1260、1262是彼此对称地相反设置的。除横向开口1260、1262以外,终端导管部分1250A还包括多个静脉开口1260A和多个动脉开口1262A。开口1260A、1262A相对横向开口1260、1262更小,并且绕所述导管本体的外周分布,从而进一步减少脉管壁吸住的可能性。
本发明的实施方案可以以其他具体的形式实施,而不偏离其精神或本质特征。所述已描述的实施方案应被认为是在各方面都仅是作为图示说明性的而非限制性的。因而,本发明的范围由所附的权利要求书而非前述说明书所指明。在权利要求书的含义和等同范围内的所有变化都应被包含在本发明的范围内。

Claims (28)

1.一种导管组件,包括:
导管本体,所述导管本体限定至少一第一内腔和第二内腔,所述导管本体包括远侧末端区域,所述远侧末端区域包括:
至少一个静脉横向开口,所述至少一个静脉横向开口与所述第一内腔流体连通,所述至少一个静脉横向开口由通过所述导管本体外周的一成角度的横向切口限定并且包括面对远侧的部分;以及
至少一个动脉横向开口,所述至少一个动脉横向开口与所述第二内腔流体连通,所述至少一个动脉横向开口由通过所述导管本体外周的一成角度的横向切口限定并且包括面对远侧的部分,所述至少一个动脉横向开口相对于所述至少一个静脉横向开口以大致非交错结构的方式被相对地设置,所述静脉横向开口和所述动脉横向开口赋予从所述静脉横向开口和所述动脉横向开口流出的流体横向和向远侧的方向。
2.根据权利要求1所述的导管组件,其中所述至少一个静脉横向开口和所述至少一个动脉横向开口相对于彼此被对称地设置。
3.根据权利要求1所述的导管组件,还包括一远侧端开口。
4.根据权利要求3所述的导管组件,其中所述远侧端开口与由所述导管本体限定的第三内腔连通。
5.根据权利要求3所述的导管组件,其中所述远侧端开口与所述第一内腔连通。
6.根据权利要求5所述的导管组件,其中可以经由一导丝槽自所述第一内腔穿过所述远侧端开口而通过一导丝,所述导丝槽与所述第一内腔和所述远侧端开口两者连通。
7.根据权利要求3所述的导管组件,其中所述第一和第二内腔限定圆形截面形状,其中所述远侧端开口与由所述导管本体限定的第三内腔流体连通,所述第三内腔限定圆形截面形状,并且其中所述导管本体的外周限定一长圆形截面形状。
8.根据权利要求7所述的导管组件,其中所述第三内腔可以耐受从所述第三内腔穿过的在约3毫升/秒和约8毫升/秒之间的流率。
9.根据权利要求1所述的导管组件,其中所述至少一个静脉横向开口和所述至少一个动脉横向开口提供在正流动方向上和在反流动方向上基本上相等的再循环率。
10.根据权利要求1所述的导管组件,其中所述远侧末端区域还限定锥形鼻状部分,所述至少一个静脉横向开口和所述至少一个动脉横向开口两者的一部分被限定在所述鼻状部分上。
11.根据权利要求10所述的导管组件,还包括被限定在所述鼻状部分的中心的一远侧端开口。
12.根据权利要求10所述的导管组件,其中所述鼻状部分包括相对于限定所述导管本体的材料具有低的硬度的材料。
13.根据权利要求12所述的导管组件,其中所述导管本体包括具有肖氏硬度D约为60的材料,并且其中所述鼻状部分包括具有肖氏硬度A约为85的材料。
14.根据权利要求13所述的导管组件,其中所述鼻状部分包括基于聚氨酯的树脂。
15.一种导管组件,包括:
导管本体,所述导管本体限定第一内腔和第二内腔,所述导管本体包括远侧末端区域,所述远侧末端区域包括:
锥形鼻状部分;
静脉横向开口,所述静脉横向开口与所述第一内腔流体连通并且被限定在所述鼻状部分的一部分上,所述静脉横向开口由通过所述导管本体外周的一成角度的横向切口限定;以及
动脉横向开口,所述动脉横向开口与所述第二内腔流体连通并且被限定在所述鼻状部分的一部分上,所述动脉横向开口由通过所述导管本体外周的一成角度的横向切口限定,所述静脉横向开口和所述动脉横向开口赋予从所述静脉横向开口和所述动脉横向开口流动的流体至少一横向的方向。
16.根据权利要求15所述的导管组件,其中所述鼻状部分包括具有相对于所述导管本体的硬度更低的硬度的材料。
17.根据权利要求16所述的导管组件,其中所述鼻状部分通过RF熔合被接合到所述导管本体的远侧端。
18.根据权利要求15所述的导管组件,其中所述静脉横向开口和动脉横向开口绕所述导管本体的圆周的至少一部分被限定,从而防止脉管壁吸住。
19.根据权利要求15所述的导管组件,其中所述静脉横向开口和动脉横向开口由限定8字形形状的外周限定。
20.根据权利要求15所述的导管组件,还包括:
与所述导管本体的所述第一内腔流体连通的第一预先弯曲的延伸腿;以及
与所述导管本体的所述第二内腔流体连通的第二预先弯曲的延伸腿。
21.根据权利要求15所述的导管组件,其中当被插入到患者的脉管系统中时:
在第一操作结构状态,血液经由所述动脉横向开口从所述脉管系统抽吸,并且血液经由所述静脉远侧开口注入所述脉管系统;并且
在第二操作结构状态,血液经由所述静脉横向开口从所述脉管系统抽吸,并且血液经由所述动脉远侧开口注入所述脉管系统。
22.根据权利要求15所述的导管组件,其中所述静脉横向开口和动脉横向开口被这样限定,以至每一个横向开口的长轴限定一相对于所述导管本体纵轴的锐角,从而赋予自所述横向开口的流体流出横向和向远侧的流动方向。
23.一种导管组件,包括:
导管本体,所述导管本体限定第一内腔和第二内腔,所述导管本体包括远侧末端区域,所述远侧末端区域包括:
鼻状部分,所述鼻状部分限定向远侧缩小的外表面;
与所述第一内腔流体连通并且由通过所述导管本体外周的一成角度的横向切口限定的静脉横向开口,所述静脉横向开口被至少部分地限定在所述向远侧缩小的外径上;以及
与所述第二内腔流体连通并且由通过所述导管本体外周的一成角度的横向切口限定的动脉横向开口,所述动脉横向开口被至少部分地限定在所述向远侧缩小的外径上,所述静脉横向开口和所述动脉横向开口赋予从所述静脉横向开口和所述动脉横向开口流动的流体至少一横向的方向。
24.根据权利要求23所述的导管组件,其中所述静脉横向开口和动脉横向开口中的每一个包括面对远侧的部分。
25.根据权利要求23所述的导管组件,其中导丝槽提供在一远侧端开口和所述第一和第二内腔中的一个之间的流体连通。
26.根据权利要求25所述的导管组件,其中所述远侧端开口与所述第一内腔流体连通并且其中所述导丝槽和所述远侧端开口与所述第一内腔轴向对准。
27.根据权利要求23所述的导管组件,其中所述静脉横向开口和动脉横向开口中的每一个的一部分被限定在所述远侧末端区域的终端导管部分,所述终端导管部分邻近所述鼻状部分。
28.根据权利要求23所述的导管组件,其中所述导管本体限定长圆形截面形状并且其中所述导管本体的外壁在所述外壁相对的侧上是加厚的。
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US20120089070A1 (en) 2012-04-12
CN103170050B (zh) 2015-04-29
US8092415B2 (en) 2012-01-10
US9610422B2 (en) 2017-04-04
US20090118661A1 (en) 2009-05-07
WO2009059220A1 (en) 2009-05-07
CN101918067B (zh) 2013-04-10
US8894601B2 (en) 2014-11-25
JP2011502583A (ja) 2011-01-27
US20150073336A1 (en) 2015-03-12
JP5452498B2 (ja) 2014-03-26
CN101918067A (zh) 2010-12-15

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