CN103028157A - 具有改进的侧部开口设计的血液透析导管 - Google Patents
具有改进的侧部开口设计的血液透析导管 Download PDFInfo
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Abstract
本发明提供一种血液透析导管,其包括导管主体,所述导管主体具有近侧端部和远侧端部,并且限定至少一个管腔。所述至少一个管腔包括远侧开口和贯穿所述导管主体的侧壁形成的侧部开口。所述侧部开口与所述至少一个管腔连通,并且包括与所述侧部开口的远侧相邻设置的引导结构,所述引导结构构造用于将血流顺畅地改向到所述至少一个管腔内。所述引导结构可由升高的壁部限定,或在替代形式中,由所述侧部开口的成角度的远侧壁部限定。
Description
技术领域
本发明涉及血液透析导管,更具体地,涉及具有改进的侧部开口的血液透析导管。
背景技术
导管是用于将流体引入体腔、管道和血管和从体腔、管道和血管取出流体的柔性医用器具。导管用于人体内很多不同的应用中,包括施用液体治疗剂和取出体液进行测试、监测或处理。导管在血液透析过程中具有特别的应用,其中将血液从血管取出,导向到血液透析装置进行透析或净化,随后返回到血管。
通常,透析导管限定至少两个管腔,所述至少两个管腔包括静脉管腔和动脉管腔。动脉管腔从患者取出血液,并且将血液传送到透析器。静脉管腔从透析器接收净化的血液,并且将血液返回到患者。静脉和动脉管腔可包括与导管的端头相邻的远侧端部开口。另外,静脉和动脉管腔还可包括在导管的端头近侧的侧部开口,其提供进出所述动脉和静脉管腔的冗余流动路径。
与已知的透析导管相关的一个问题是已知导管容易发生导管开口内血栓的形成。血栓为在导管管腔中形成的包括纤维蛋白、血小板、红细胞和白细胞的凝块。与导管侧部开口相邻的血栓的形成可能导致导管侧部开口的堵塞,并且部分或完全阻挡血液流到导管或从导管流出。血栓形成的可能性由于分裂血流而增大,分裂血流导致作用于血液上的剪切应力升高。
期望提供一种具有侧部开口的导管,其构造用于改善进入血液透析导管中的血流的流体动力学性能,以尽量减少血栓的形成。
发明内容
根据本发明的血液透析导管包括导管主体,其具有近侧端部和远侧端部,并且限定静脉管腔和动脉管腔。所述静脉管腔和所述动脉管腔每一个可包括远侧开口和贯穿所述导管主体的侧壁形成的侧部开口。每一个远侧开口和侧部开口与相应的静脉或动脉管腔连通。在一个实施例中,所述血液透析导管包括引导结构,其与和所述动脉管腔连通的侧部开口的远侧侧部相邻设置。所述引导结构构造用于通过所述动脉管腔侧部开口顺畅地将血流改向到所述动脉管腔中。
在一个实施例中,所述引导结构包括与所述侧部开口的远侧侧部相邻设置的升高的壁部。所述升高的壁部可限定收集部,所述收集部至少部分在所述侧部开口的远侧端部上延伸。所述收集部可包括形成圆角的近侧表面,所述近侧表面构造用于将血流顺畅地改向到所述导管的动脉管腔中。
在一个实施例中,所述收集部的高度h在所述导管的侧壁外表面上方延伸约t至约3t,其中,t为所述导管的侧壁的厚度。在一个实施例中,h为约1.5t。
在另一个实施例中,所述引导结构包括限定所述侧部开口的成角度的远侧内壁部。所述成角度的远侧内壁部限定与所述导管的侧壁的外表面相邻的锐角β。
在一个实施例中,β在约15度和约75度之间。在另一个实施例中,β为约45度。
在一个实施例中,引导结构与和所述静脉管腔连通的所述侧部开口的远侧端部相邻形成。
在一个实施例中,所述血液透析导管是可逆的,并且与和所述静脉管腔连通的所述侧部开口的远侧端部相邻形成的引导结构与所述导管的侧壁的外表面限定锐角β,其中,β在约15度和约75度之间。在另一个实施例中,β为约45度。
在一个实施例中,与所述静脉管腔连通的侧部开口由基本上垂直于所述导管的外表面的壁部限定。
在一个实施例中,所述血液透析导管是不可逆的,并且与和所述静脉管腔连通的侧部开口的远侧端部相邻形成的引导结构包括与所述导管的内表面限定锐角β的成角度的远侧内壁部。
在一个实施例中,用于从患者取出流体的导管包括导管主体,其限定第一管腔,所述第一管腔具有与所述导管主体的远侧端部间隔开的侧部开口,所述侧部开口与所述第一管腔连通。所述导管主体包括与所述侧部开口的远侧端部相邻设置的引导结构,其构造用于将流体流通过所述侧部开口顺畅地改向到所述第一管腔内。
在一个实施例中,引导结构包括与所述侧部开口的远侧端部相邻设置的升高的壁部。所述升高的壁部可限定收集部,所述收集部包括形成圆角的面向近侧的表面。
在另一个实施例中,引导结构包括限定所述侧部开口的成角度的远侧内壁部,其与所述导管主体的外表面限定角度β,其中,β在约15度和约75度之间。在另一个实施例中,角度β在约30度和约60度之间。
附图说明
图1是本发明公开的血液透析导管的一个实施例的远侧端部的侧视立体视图;
图2是图1中所示的标示细部区域的放大视图;
图3是沿图2的剖切线3-3截取的剖视图;
图4是沿图2的剖切线4-4截取的剖视图;
图4A是本发明公开的血液透析导管的另一个实施例的剖视图;
图5是本发明公开的血液透析导管的另一个实施例的远侧端部的侧视立体视图;
图6是沿图5的剖切线6-6截取的剖视图;
图6A是图6中所示的标示细部区域的放大视图;
图7是本发明公开的血液透析导管的一个替代实施例的侧剖视图;
图7A是图7中所示的标示细部区域的放大视图;
图8是本发明公开的血液透析导管的另一个替代实施例的侧剖视图。
具体实施方式
本文中讨论了本发明公开的血液透析导管的多个示例性实施例。可预见的是,本发明的原理同样可用于一系列其他已知的导管应用,例如用于慢性和急性应用的心脏、腹部、泌尿和肠导管。
在下面的讨论中,术语“近侧”和“后侧”可以可互换地应用,并且应理解为指结构的在适当使用过程中更靠近临床医生的部分。术语“远侧”和“前侧”也可以可互换地应用,并且应理解为结构的在适当使用过程中更远离临床医生的部分。如本文所用,术语“患者”应理解为指人类患者或其他动物,并且术语“临床医生”应可理解为指医生、护士或其他护理提供者,并且可包括保障人员。
图1-4示出总体以10显示的本发明公开的导管的一个示例性实施例。导管10包括限定第一管腔14和第二管腔16(图4)的导管主体12。如图所示,第一和第二管腔14和16基本上为D型。替代地,可预见的是,管腔14和16可具有包括圆形、椭圆形等多种构型。隔膜18从主体10的近侧端部延伸到主体10的远侧端部。在一个实施例中,隔膜18延伸到限定主体10的外周的侧壁20的远侧端部的远侧。
导管主体12限定一对远侧开口22和一对径向相对的侧部开口24,所述侧部开口在远侧开口22的近侧间隔开。在一个实施例中,每一个远侧开口22限定在隔膜18和侧壁20的远侧螺旋形构型侧壁延伸部26之间。包括相似构型的远侧侧壁延伸部26在美国专利No.7,776,005中公开,所述专利以引用的方式以其全文并入本文中。替代地,可预见的是,导管10的远侧端部可具有本领域中已知的各种构型。
侧部开口24在在远侧开口22近侧间隔开的位置处贯穿导管主体12的侧壁20形成。每一个开口24与第一和第二管腔14和16中的一个连通。如图所示,开口24设置在主体10上的径向相对位置中。但是,可预见,开口24可设置在管腔14和16上的任意位置中;并且也可进一步以多个设置。虽然开口24示出为具有椭圆形的构型,但是可预见其他构型,包括多边形、矩形、方形、梯形、圆形和其他规则和不规则形状的开口。
如图1-4中所示,每一个侧部开口24的远侧壁部包括引导结构,用于顺畅地将血流重新引导到导管10的相应管腔14,16中。在一个实施例中,该结构包括升高的收集部32,其沿每一个侧部开口24的远侧端部形成。收集部32包括近侧表面,所述近侧表面构造用于将由图3中箭头b标示的流体流顺畅地改向到导管10的管腔14中。更具体地,收集部32的近侧壁部形成圆角,以实现将流体流顺畅地改向到导管10中。在示出的实施例中,收集部32在每一个侧部开口24的远侧端部上延伸。替代地,可预见其他收集部结构。
在一个实施例中,收集部32从侧壁20的外表面向外延伸高度h,高度h至少与侧壁20的厚度“t”(图3)一样大。在其他实施例中,收集部32的高度h在约t和约3t之间,并且可以是约1.5t。
如图4A中所示,收集部32’也可在侧部开口的近侧侧部设置在导管10’中。更具体地,具有面向远侧的引导表面的向里延伸的收集部32’可设置在管腔14中,用于将离开管腔14的流体顺畅地改向。
如上面所讨论的,双管腔血液透析导管10包括用于将血液从患者静脉取出的动脉管腔和用于将净化的血液返回到患者静脉的静脉管腔。如果导管构造成使双管腔导管的每一个管腔可用作动脉管腔和静脉管腔,则该导管归类为可逆管腔导管。可逆管腔导管的优点,例如能够解决通过导管的血流的位置性堵塞,在本领域中是已知的,并且本文中不详细讨论。但是,与侧部开口相邻的升高的收集部32也可帮助缓解由远离血管壁的侧壁20造成的位置性堵塞。
如图所示,导管10为可逆管腔导管,并且因而包括与每一个侧部开口32的远侧端部相邻设置的收集部32。可预见,收集部32可被包括在不可逆管腔导管以及可逆管腔导管中。因而,还可预见,收集部24仅需要与和动脉管腔14连通的侧部开口32的远侧端部相邻设置。因而导管可仅包括单个收集部32。
如上面所讨论的,提供收集部32或类似结构来将血流从静脉顺畅地重新导向到导管10的动脉管腔14中,这样减少了流动分裂,并且防止了血液在暴露时间暴露于升高的剪切应力。通过使将血流暴露于升高的剪切应力的情况尽量减少,使得血小板活化尽量减少,导致降低血栓形成的可能性。
图5和6示出总体以100显示的本发明公开的血液透析导管的一个替代实施例。导管100基本上与导管10相同,但是不包括一个或多个收集部32,而是导管100包括形成在限定侧部开口124a的远侧内壁上的引导结构,用于将血流顺畅地改向到导管100的动脉管腔114中。更具体地,如图6中所示,导管100包括侧部开口124a,其由成角度的内壁140限定。限定侧部开口124a的远侧内壁140a(图6A)限定与侧壁120的外表面142相邻的锐角β,其中β在约15度和约75度之间。在一个实施例中,角度β在约30度和约60度之间。在又一个实施例中,角度β约为45度。
如图6中所示,导管100包括径向相对的侧部开口124b,其以与侧部开口124a相同的方式构造。因而,侧部开口124a和124b中的每一个包括远侧内壁140a,所述远侧内壁限定与导管100的侧壁120的外表面142相邻的在约15度和约75度之间的锐角β。通过提供具有限定与导管100的侧壁120的外表面142相邻的锐角β的远侧内壁140a的侧壁开口124a和124b,血流可被顺畅地导向到每一个侧部开口124a和124b。因而,每一个管腔114或116可用作具有最小化流动分裂、最小化血小板活化和减少的血栓的动脉管腔。
图7示出总体以200显示的本发明公开的血液透析导管的一个替代实施例。导管200构造成不可逆的。这样,如上面参照侧部开口124a和124b(图6)所述,构造侧部开口224b,来将血流顺畅地导向到动脉管腔214中。相反,侧部开口224a构造用于顺畅地将血流导向出静脉管腔216。这样,侧部开口224a的远侧内壁240a限定与侧壁220的内表面224相邻的在约15度和约75度之间的锐角β。
图8示出总体以300显示的本发明公开的血液透析导管的另一个替代实施例。导管300基本上与导管100相同,因为侧部开口324a与侧部开口124a相同。但是,侧部开口324b由竖直侧壁340限定。
在导管100,200和300中的每一个中,限定相应侧部开口的内近侧壁部可具有对应于远侧内壁部的角度的角度。替代地,内近侧壁部可具有多种角度构型。虽然导管100,200和300中的每一个示出包括椭圆形侧部开口,但是可预见,所述侧部开口可具有多种构型,包括圆形、矩形、方形或任何其他多边形、规则或不规则形状。
本领域技术人员应可理解,本文中特别描述并且在附图中示出的装置和方法是非限制性的示例性实施例。可预见,关于一个示例性实施例示出或描述的元件和特征可与另一个的元件和特征组合而不偏离本发明的范围。而且,本领域技术人员将根据上面所述的实施例意识到本发明的其他特征和优点。因此,本发明不受已经特别显示和描述的内容限制,除非所附权利要求说明。
Claims (21)
1.一种血液透析导管,包括:
导管主体,所述导管主体具有侧壁和隔膜,限定静脉管腔和动脉管腔,所述静脉管腔和动脉管腔包括远侧开口和贯穿所述导管主体的侧壁形成的侧部开口,所述侧部开口从所述侧壁的外表面延伸到内表面,远侧开口和侧部开口中的每一个与相应的静脉管腔或动脉管腔连通,并且与所述侧部开口的远侧端部相邻设置的引导结构与所述动脉管腔连通,其中,所述引导结构构造用于将血流通过动脉管腔侧部开口改向到所述动脉管腔中。
2.根据权利要求1所述的血液透析导管,其中,所述引导结构包括与所述侧部开口的远侧端部相邻设置的升高的壁部。
3.根据权利要求2所述的血液透析导管,其中,所述升高的壁部限定收集部,所述收集部至少部分在所述侧部开口的远侧端部上延伸。
4.根据权利要求3所述的血液透析导管,其中,所述收集部包括形成圆角的面向近侧的表面,所述形成圆角的面向近侧的表面从所述侧壁的外表面延伸,构造用于将血流改向到所述导管的动脉管腔内。
5.根据权利要求3所述的血液透析导管,其中,所述引导结构还包括收集部,所述收集部包括形成圆角的面向远侧的表面,所述形成圆角的面向远侧的表面从与和所述静脉管腔连通的侧部开口的近侧端部相邻的侧壁内表面延伸,所述收集部构造用于将血流改向出所述导管的静脉管腔,以及构造用于将血流改向到所述导管的动脉管腔中。
6.根据权利要求4所述的血液透析导管,其中,所述收集部在所述导管的侧壁的外表面上方延伸高度h,所述高度h在约t和约3t之间,其中,t为所述导管的侧壁的厚度。
7.根据权利要求6所述的血液透析导管,其中,h为约1.5t。
8.根据权利要求1所述的血液透析导管,其中,所述引导结构包括限定所述动脉管腔的侧部开口的成角度的远侧内壁部,所述成角度的远侧内壁部与所述导管的侧壁的外表面限定锐角β。
9.根据权利要求8所述的血液透析导管,其中,β在约15度和约75度之间。
10.根据权利要求9所述的血液透析导管,其中,β为约45度。
11.根据权利要求8所述的血液透析导管,还包括与和所述静脉管腔连通的侧部开口的远侧端部相邻形成的引导结构。
12.根据权利要求11所述的血液透析导管,其中,所述血液透析导管是可逆的,并且所述与和所述静脉管腔连通的侧部开口的远侧端部相邻形成的引导结构包括成角度的远侧内壁部,所述远侧内壁部限定所述静脉管腔的侧部开口,所述成角度的远侧内壁部与所述导管的侧壁的外表面限定锐角β。
13.根据权利要求12所述的血液透析导管,其中,β在约15度和约75度之间。
14.根据权利要求13所述的血液透析导管,其中,β为约45度。
15.根据权利要求11所述的血液透析导管,其中,与所述静脉管腔连通的侧部开口由基本上垂直于所述导管的外表面和内表面的壁部限定。
16.根据权利要求11所述的血液透析导管,其中,所述血液透析导管是不可逆的,并且所述与和所述静脉管腔连通的侧部开口的远侧端部相邻形成的引导结构包括限定所述静脉管腔的侧部开口的成角度的远侧内壁部,所述限定所述静脉管腔的侧部开口的成角度的远侧内壁部与所述导管的内表面限定锐角β。
17.一种用于从患者取出流体的导管,包括:
导管主体,所述导管主体限定第一管腔,所述第一管腔具有与所述导管主体的远侧端部间隔开并且与所述第一管腔连通的侧部开口,所述导管主体包括与所述侧部开口的远侧端部相邻设置的引导结构,所述引导结构构造用于将流体流通过所述侧部开口改向到所述第一管腔内。
18.根据权利要求17所述的导管,其中,所述引导结构包括与所述侧部开口的远侧端部相邻设置的升高的壁部。
19.根据权利要求18所述的导管,其中,所述升高的壁部限定收集部,所述收集部包括形成圆角的面向近侧的表面。
20.根据权利要求19所述的导管,其中,所述引导结构包括限定所述侧部开口的成角度的远侧内壁部,所述远侧内壁部与所述导管主体的外表面限定角度β,其中,β在约15度和约75度之间。
21.根据权利要求20所述的导管,其中,β在约30度和约60度之间。
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- 2012-09-27 JP JP2012214681A patent/JP2013078578A/ja active Pending
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CN106413607A (zh) * | 2014-02-21 | 2017-02-15 | 悉尼儿童医院网络(兰德威克和韦斯米) | 可植入装置 |
CN106999094A (zh) * | 2014-12-01 | 2017-08-01 | 皇家飞利浦有限公司 | 用于基于导管的导航的虚拟定向的电磁跟踪线圈 |
CN104922784A (zh) * | 2015-07-01 | 2015-09-23 | 乐普(北京)医疗器械股份有限公司 | 一种药物球囊导管 |
USD975844S1 (en) | 2019-11-06 | 2023-01-17 | Free Life Medical Gmbh | Cannula |
Also Published As
Publication number | Publication date |
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CA2790047A1 (en) | 2013-03-30 |
US8747343B2 (en) | 2014-06-10 |
CN103028157B (zh) | 2015-06-17 |
US20130085438A1 (en) | 2013-04-04 |
AU2012230094A1 (en) | 2013-04-18 |
MX2012010917A (es) | 2013-04-01 |
EP2574365A1 (en) | 2013-04-03 |
JP2013078578A (ja) | 2013-05-02 |
BR102012024688A2 (pt) | 2013-08-06 |
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