CN103028186A - 具有外部流动通道的导管 - Google Patents

具有外部流动通道的导管 Download PDF

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CN103028186A
CN103028186A CN2012103664202A CN201210366420A CN103028186A CN 103028186 A CN103028186 A CN 103028186A CN 2012103664202 A CN2012103664202 A CN 2012103664202A CN 201210366420 A CN201210366420 A CN 201210366420A CN 103028186 A CN103028186 A CN 103028186A
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groove
side mouth
conduit
conduit according
tube chamber
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A·S·马勒西
R·M·布拉加
T·M·约翰斯顿
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Covidien LP
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Tyco Healthcare Group LP
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    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
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    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
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    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
    • A61M1/3659—Cannulae pertaining to extracorporeal circulation
    • A61M1/3661—Cannulae pertaining to extracorporeal circulation for haemodialysis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M25/003—Multi-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
    • A61M2025/0031—Multi-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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M25/0028—Multi-lumen catheters with stationary elements characterized by features relating to at least one lumen located at the proximal part of the catheter, e.g. alterations in lumen shape or valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M25/0029—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure

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Abstract

本发明提供了一种导管，所述导管包括本体，所述本体具有近端部、远端部和限定有至少一个管腔的侧壁。所述导管本体具有在所述远端部近侧的隔开的位置处穿过所述侧壁形成的至少一个侧部开口。所述至少一个侧部开口与所述至少一个管腔连通。凹槽沿着所述侧壁延伸，并且与所述至少一个侧部开口连通，使得所述凹槽限定进入所述侧部开口内的流体通路。

Description

具有外部流动通道的导管
技术领域
本公开涉及用于在医疗过程中使用的导管，并且具体地，涉及用于在医疗过程期间将流体从身体中抽出的导管。
背景技术
导管是用于在将流体引入体腔、管道和脉管中以及将流体从体腔、管道和脉管中抽出时使用的柔性医疗器械。导管用于在人体内的很多不同应用，包括注射液体治疗剂和移取体液以用于检测、监控或处置。导管具有在血液透析过程中的特定应用，在血液透析过程中将血液从血管中抽出，引导到用于透析或净化的血液透析单元中，并且随后送回到血管中。
典型地，透析导管限定有包括静脉管腔和动脉管腔的至少两个管腔。动脉管腔将血液从患者体内抽出并且将血液输送到透析机中。静脉管腔从透析机接收血液并且将血液送回到患者体内。静脉管腔和动脉管腔可以包括与导管的顶端相邻的远侧开口。另外，静脉管腔和动脉管腔也可以包括侧部开口，侧部开口提供往返动脉管腔和静脉管腔的多余的或替代的流路。
当导管被置于体腔中并且通过导管的管腔例如动脉管腔将流体抽出时，使导管管腔与体腔连通的一个或多个导管开口可能被阻塞。更具体地，由于用于将流体从脉管中抽出的导管管腔抽吸出与开口相邻的真空，因此身体组织可能被吸入动脉管腔的远侧开口和/或侧部开口内并且使开口阻塞。尽管通过设置远侧开口和侧部开口两者生成的多余流路减小了导管抽出管腔的全部阻塞的可能性，但是期望的是对于已知导管进行进一步改进以进一步减小脉管阻塞的可能性。
由此，期望的是通过提供一种导管来克服与已知导管关联的缺点，所述导管不太容易阻塞并且能够提供进入导管内的不受阻塞的流体流动。
发明内容
根据本公开的导管包括具有近端部和远端部的本体。所述导管本体包括侧壁，所述侧壁限定有至少一个管腔和在所述远端部近侧的隔开的位置处穿过所述侧壁形成的至少一个侧部开口。所述至少一个侧部开口与所述至少一个管腔连通。凹槽沿着所述侧壁延伸且与所述至少一个侧部开口连通，以限定进入所述侧部开口内的流体通路。
在一个实施例中，所述本体限定有至少一个远侧开口，所述至少一个远侧开口与所述至少一个管腔连通且在所述至少一个侧部开口的远侧设置。
在一个实施例中，所述至少一个管腔包括第一管腔和第二管腔，而所述至少一个侧部开口包括第一和第二侧部开口。第一和第二凹槽可以设置为分别与所述第一和第二侧部开口连通。
在一个实施例中，所述至少一个凹槽为基本线性的。可选地，所述至少一个凹槽可以为非线性的。
所述至少一个凹槽可以从所述至少一个侧部开口向近侧延伸。可选地，所述至少一个凹槽可以从所述至少一个侧部开口向远侧延伸。
在一个实施例中，所述至少一个凹槽包括与所述至少一个侧部开口中的每一个连通的多个凹槽。所述多个凹槽可以为线性的或非线性的，并且可以从所述侧部开口向近侧或向远侧延伸。
在一个实施例中，所述侧壁的限定所述凹槽的基部的一部分具有沿朝向所述侧部开口的方向减小的厚度。类似地，所述侧壁的限定所述凹槽的基部的一部分可以向下朝向所述侧部开口倾斜。
在另一实施例中，所述侧壁的限定所述凹槽的基部的一部分包括波动表面。
附图说明
本文将参照附图描述本公开的各种实施例，其中：
图1是本公开导管的一个实施例的远端部的立体图；
图2是图1中所示的导管的远端部的一部分的侧视截面图；
图2A是图1中所示的导管的可选实施例的远端部的侧视截面图；
图3是沿着图1的截面线3-3截取的截面图；
图4是本公开导管的另一实施例的远端部的立体图；
图5是沿着图4的截面线5-5截取的截面图；
图6是本公开导管的又一实施例的远端部的侧视立体图；
图7是本公开导管的另一实施例的远端部的立体图；
图8是沿着图7的截面线8-8截取的截面图；
图9是本公开导管的另一实施例的远端部分的侧视截面图；
图9A是图9的导管的横向截面图；
图10是图9中所示的导管在流体通过侧部开口进入导管内时的侧视截面图；
图10A是图10的导管的横向截面图；
图11是图9中所示的导管在流体从导管的侧部开口中排出时的侧视截面图；
图11A是图11的导管的横向截面图；以及
图12是本公开导管的另一实施例的远端部分的侧视截面图。
具体实施方式
本公开导管的各种示例性实施例在本文以血液透析导管的名义进行讨论。但是，构想的是，本公开的原理等同地应用到大量导管应用例如血液透析、心脏的、腹腔的、泌尿的、和肠的应用（包括慢性和急性应用）中。此外，导管能够用于输送和/或抽出流体，例如药剂、生理盐水、体液、血液和尿液。
在下面的讨论中，术语“近侧”和“尾侧”可以互换地使用，并且应当理解为指的是结构在正确使用期间更靠近临床医生的部分。术语“远侧”和“前侧”也可以互换地使用，并且应当理解为指的是结构在正确使用期间更远离临床医生的部分。在本文中使用时，术语“患者”应当理解为指的是病人或其他动物，而术语“临床医生”应当理解为指的是医生、护士或其他照料提供者并且可以包括支持人员。
图1-图3图示了本公开导管的整体上示出为10的一个实施例。导管10包括限定有第一管腔14和第二管腔16的导管本体12。如图示，第一管腔14和第二管腔16为基本D形的。可选地，构想的是管腔14和16可以具有包括圆形在内的多种构型。隔膜18从本体10的近端部延伸到本体10的远端部。在一个实施例中，隔膜18延伸到侧壁20的远端部的远侧，侧壁20限定本体12的外周缘。
本体12限定有一对远侧开口22和在远侧开口22近侧的隔开的一对径向相对的侧部开口24。在一个实施例中，每个远侧开口22限定在隔膜18与侧壁20的远侧螺旋构造的侧壁延伸部26之间。美国专利No.7,776,005中公开了包括相似构造的远侧侧壁延伸部26的导管，该专利的全部内容通过参引的方式并入本文。可选地，构想的是导管10的远端部可以采用本领域中已知的多种构型。
侧部开口24在远侧开口22的近侧在隔开的位置处穿过导管本体12的侧壁20形成。每个开口24与第一管腔14和第二管腔16中的对应的一个连通。如图示，开口24设置在本体10上的径向相对的位置中。可选地，开口24可以不是径向相对的。尽管开口24图示为具有椭圆形构型，但是可以构想其他构型包括多边形、矩形、方形、梯形、圆形、以及其他规则和不规则形状开口。
如图1-图3中所示，凹槽32在每个侧部开口24的近侧限定在侧壁20中。凹槽32可以限定球形凹入部、矩形通道或者具有限定设置在侧壁20的外表面下的通道的任意期望构型。每个凹槽32与侧部开口24连通以限定进入第一管腔14和第二管腔16中的对应一个内的另外的流路。如将在下文进一步详细讨论的，通过设置与侧部开口24连通的另外的流路，如果侧部开口24被阻塞，该另外的流路提供用于维持侧部开口24的开放性的方式。
在一个实施例中，凹槽32的长度介于0.25cm与大约3cm之间。在一个实施例中，凹槽32的长度介于大约0.5cm与大约1cm之间。在另一实施例中，凹槽32的长度为大约2cm。
当导管10在医疗过程例如血液透析过程中使用时，将导管10置于静脉典型地为用于中央静脉导管的上腔静脉中，穿过颈部中的颈内静脉并且向下朝向胸部前进。导管10的近端部以已知的方式连接到透析仪上，使得第一管腔14和第二管腔16中的一个限定导管10的动脉管腔并且第一管腔14和第二管腔16中的一个限定导管10的静脉管腔。如上讨论，动脉管腔用来将血液从患者的静脉中抽出并且将血液输送到透析仪，而静脉管腔将血液从透析仪送回到患者的静脉中。由于负压力在动脉管腔内作用，因此组织可能被吸入导管10的远侧开口14、16和/或侧部开口24内而阻塞一个或两个开口。在组织被吸入动脉管腔的侧部开口24内的情况下，凹槽32提供进入侧部开口24内的可选流路以维持开口的开放性并且有利于通过侧部开口24的连续流动。另外，如果侧部开口24靠置在静脉壁上并且由此被阻塞，则凹槽将提供保持侧部开口24的开放性的方式。
图2A图示了导管10的整体上示出为10’的可选实施例。导管10’包括限定有侧部开口24’的侧壁20’。凹槽32’如上关于导管10的凹槽32讨论的那样在侧壁20’中形成。另外，侧壁20’的形成有凹槽32’的部分33’向下变形，使得部分33’的外表面限定向下倾斜的表面，该表面引入到侧部开口24’和动脉管腔14’内。在一个实施例中，导管10’能够通过使用受热模具将壁部分33’（其限定导管10的凹槽32’的底部）向下迫压到图2A中所示的位置而形成。可选地，部分33’可以使用任意已知的模制工艺或机加工工艺形成。
图4和图5图示了本公开导管的整体上示出为100的可选实施例。除了凹槽132在侧部开口124的远侧设置在导管100的远端部与侧部开口124之间以外，导管100在所有方面与导管10基本类似。
图6图示了本公开导管的整体上示出为200的另一可选实施例。导管200与导管10的基本相似之处在于导管200包括在侧部开口224近侧设置的凹槽232。但是，与导管10相比，凹槽232是非线性的或弯曲的。尽管未示出，但是弯曲的凹槽232也可以在侧部开口224的远侧设置。使凹槽232弯曲可以通过将凹槽232的一部分更远离脉管组织定位而进一步增强防止完全闭塞的益处。这在侧部开口224靠置在静脉壁上的情况下可能是特别合适的。
在图7和图8中所示的又一可选实施例中，导管300包括在侧部开口324近侧设置且与侧部开口324连通的多个间隔开的凹槽332。尽管图示了两个凹槽332，但是构想的是多个凹槽332可以或者在每个侧部开口324的远侧、或者在每个侧部开口324的近侧、或者在每个侧部开口324的远侧和近侧设置。另外，构想的是多个凹槽332中的一个或多个可以为弯曲的、线性的、或弯曲和线性的任意组合。
在图9-图11A中所示的另一可选实施例中，图示为单管腔导管的导管400包括侧部开口424和在侧部开口424近侧设置的凹槽432。导管400与上述导管10的不同之处在于侧壁420的限定凹槽432的底壁420a的部分向下朝向侧部开口424沿远侧方向渐缩，即，在凹槽432的基部处的侧壁420的厚度沿远侧方向减小。这种构型使底壁420a能够在管腔414作为动脉管腔时稍向内弯曲（图10）到管腔414内或者在管腔414作为静脉管腔时稍向外弯曲（图11）。凹槽432的底壁420a的柔性在使用期间容许流体较平滑地流入导管400和从导管中流出。底壁420的较厚的近侧部分向底壁420a增加一些刚性以限制底壁420a能够弯曲的程度。
如在本公开的整体上示出为500的导管的又一实施例中所示，限定凹槽532的底壁520a的整个长度能够变薄以向底壁520a提供较大的柔性以使底壁520a能够如图10-图11A中所示地弯曲。尽管导管400和500图示为单管腔导管，但是构想的是以上关于导管400和500讨论的优点等同地应用到双管腔导管，例如在本申请的图1-图8中所示的导管。
尽管未在附图中清楚示出，但是构想的是在本文公开的实施例的任一个或全部中的限定凹槽的底壁可以沿纵向方向或横向方向为非线性的。例如，限定凹槽的底壁可以沿纵向方向和/或横向方向为波动的或者具有波浪状或不规则构型。构想的是这种非线性表面构型可以使侧部开口的阻塞的可能性进一步最小化。
尽管以上讨论的导管实施例中的每一个将凹槽描述为与径向设置的侧部开口中的每一个相关联，但是构想的是凹槽可以与仅仅单个侧部开口相关联。由此，在不可逆透析导管中，凹槽可以仅仅关联于与动脉管腔连通的侧部开口。
尽管图示实施例包括远侧开口和侧部开口，但是构想的是导管可以仅仅包括侧部开口，侧部开口具有与侧部开口中的一个或两个相关联的凹槽。另外，尽管本公开图示了双管腔导管的实施例，但是还构想的是侧部开口和凹槽的组合能够应用到单管腔导管上。
除了以上关于设置与侧部开口连通的凹槽所述的优点以外，还确信的是这种构型提供了其他优点。更具体地，设置与侧部开口连通的凹槽导致进入侧部开口内的较平滑的流动动力学，即，较小的流动破坏。通过提供进入侧部开口内的较平滑的流动动力学，使作用在流体例如血液上的不适当的剪应力最小化，从而导致最小化的血小板聚集和减少的血栓。为了使透析导管中的这些另外的优点最大化，凹槽可以在与动脉管腔连通的侧部开口近侧设置。
本领域的技术人员将理解的是，本文具体描述且在附图中图示的装置和方法为非限制示例性实施例。构想的是，结合一个示例性实施例图示或描述的元件和特征可以与另一实施例的元件和特征相结合而不偏离本公开的范围。同样地，本领域的技术人员将明白基于上述实施例的公开的其他特征和优点。因此，本公开不限于除了由所附权利要求指出的以外的、已经具体示出和描述的那些。

Claims (15)

1.一种导管，包括：
具有近端部和远端部的本体，所述本体包括侧壁，所述侧壁限定有至少一个管腔和在所述远端部近侧的隔开的位置处穿过所述侧壁形成的至少一个侧部开口，所述至少一个侧部开口与所述至少一个管腔连通，并且所述本体还包括沿着所述侧壁延伸且与所述至少一个侧部开口连通的凹槽，所述凹槽限定进入所述侧部开口内的流体通路。
2.根据权利要求1所述的导管，其中，所述本体限定有与所述至少一个管腔连通的至少一个远侧开口，所述至少一个远侧开口在所述至少一个侧部开口的远侧设置。
3.根据权利要求2所述的导管，其中，所述至少一个管腔包括第一管腔和第二管腔。
4.根据权利要求3所述的导管，其中，所述至少一个侧部开口包括第一侧部开口和第二侧部开口。
5.根据权利要求4所述的导管，其中，所述凹槽包括第一凹槽和第二凹槽，所述第一凹槽和第二凹槽分别与所述第一侧部开口和第二侧部开口连通。
6.根据权利要求1所述的导管，其中，所述至少一个凹槽为基本线性的。
7.根据权利要求1所述的导管，其中，所述至少一个凹槽为非线性的。
8.根据权利要求2所述的导管，其中，所述至少一个凹槽从所述至少一个侧部开口向近侧延伸。
9.根据权利要求2所述的导管，其中，所述至少一个凹槽从所述至少一个侧部开口向远侧延伸。
10.根据权利要求8所述的导管，其中，所述至少一个凹槽包括与所述至少一个侧部开口连通的多个凹槽。
11.根据权利要求9所述的导管，其中，所述至少一个凹槽包括与所述至少一个侧部开口连通的多个凹槽。
12.根据权利要求1所述的导管，其中，所述至少一个凹槽具有大约0.5cm至大约1.0cm的长度。
13.根据权利要求1所述的导管，其中，所述侧壁的限定所述凹槽的基部的一部分具有沿朝向所述侧部开口的方向减小的厚度。
14.根据权利要求1所述的导管，其中，所述侧壁的限定所述凹槽的基部的一部分向下朝向所述侧部开口倾斜。
15.根据权利要求1所述的导管，其中，所述侧壁的限定所述凹槽的基部的一部分包括波动表面。
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