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CN101918066A - 分裂末端导管的制造 - Google Patents

分裂末端导管的制造 Download PDF

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CN101918066A
CN101918066A CN2008801211835A CN200880121183A CN101918066A CN 101918066 A CN101918066 A CN 101918066A CN 2008801211835 A CN2008801211835 A CN 2008801211835A CN 200880121183 A CN200880121183 A CN 200880121183A CN 101918066 A CN101918066 A CN 101918066A
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inner chamber
catheter body
end segment
equipment
distally
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CN101918066B (zh
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S·D·尼米卡
C·老迪弗雷那
E·托宾
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Spire Corp
Bard Access Systems Inc
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    • A61M25/0009—Making of catheters or other medical or surgical tubes
    • A—HUMAN NECESSITIES
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    • A61M25/00—Catheters; Hollow probes
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    • 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
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    • 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
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M25/00—Catheters; Hollow probes
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    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M25/007—Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0074—Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
    • 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
    • A61M25/008—Strength or flexibility characteristics of the catheter tip
    • A—HUMAN NECESSITIES
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    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0194—Tunnelling catheters
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
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    • Y10T156/1052—Methods of surface bonding and/or assembly therefor with cutting, punching, tearing or severing
    • Y10T156/1062—Prior to assembly
    • Y10T156/1064—Partial cutting [e.g., grooving or incising]
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
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    • Y10T156/10—Methods of surface bonding and/or assembly therefor
    • Y10T156/1052—Methods of surface bonding and/or assembly therefor with cutting, punching, tearing or severing
    • Y10T156/1082—Partial cutting bonded sandwich [e.g., grooving or incising]
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
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    • Y10T29/00—Metal working
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    • Y10T29/49826—Assembling or joining
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
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Abstract

公开了具有至少一个分裂末端的端的多内腔导管设备，以及形成这样的分裂末端导管的方法。在本发明的一个方面，制造方法可以包括以下步骤：提供导管本体，所述导管本体具有纵向延伸通过所述导管本体的至少第一内腔和第二内腔；去除所述导管本体的一远侧部分来形成第一远侧末端段，以致所述第一内腔在这一末端段内纵向延伸超过所述第二内腔；以及将第二内腔末端段以与所述第二内腔连通的方式接合到所述导管本体。所述第二末端段可以这样被接合到所述导管本体，以致所述第二末端段至少部分地与所述第一末端段分开，并且在某些实施方案中，所述第二末端段优选地相对于所述第一末端段以一角度分叉。

Description

分裂末端导管的制造
背景
本发明总地涉及导管，并且优选地涉及用于进入脉管的多内腔导管。
多内腔导管(multi-lumen catheter)以及特别是分裂末端导管被期望用于各种治疗应用中，例如同时发生有液体的抽出和送回的血液透析。血液透析是通过过滤，将新陈代谢的废弃物和水分从血液中分离。典型地，血液透析单元通过导管连接到患者的身体。导管的远侧端被放置在血管中并且其近侧端连接到血液透析单元。
在血液透析过程中，典型地，患者的血液通过双内腔导管至提供血液过滤和控制血液流动的血液透析单元。双内腔导管具有两个独立地允许流体抽出和送回的内腔。例如，一个内腔可以用来将血液从患者体内移出以在血液透析机中进行处理，并且另一个内腔可以用来随后将处理过的血液送回患者的循环系统。这样的导管也可以包括附加的内腔，用于冲洗、施加抗凝剂或类似的用途。
可以被改变来达到适当的血液透析的参数包括血流速度、透析液流速度以及透析器的能力。一般地，加快血流速度提高透析效率。然而，诸如通路再循环(access recirculation)等情况会降低效率。通路再循环是处理过的血液回流到血液透析单元的再循环。过量的再循环大大降低透析效率并且延长适当的透析所需的治疗持续时间。由于导管远侧末端处极为邻近的吸进(intake)和流出(outflow)端口，当使用双内腔导管时特别要考虑通路再循环的问题。
为了减少通路再循环，已经提出各种双内腔导管设计。吸进和流出内腔的远侧端已经被纵向间隔开20-30mm来防止再循环。例如，Twardowski等人在美国专利第5569182号中公开的，用于将血液送回流至静脉的内腔的终止应当超出抽出内腔。这样的目的是防止从导管的出口点流出的清洗过的血液再次进入导管的血液入口点并且回到透析机。然而，已经注意到在各自内腔的远侧端间的这样大的纵向间隔的某些缺点。例如，两个被远远分开的末端间的血管区域内的血流停滞会导致凝块的形成。
除了内腔的远侧开口的纵向间隔，其他人已提出多内腔导管的远侧端可以为分裂的，以致远侧末端段可以独立地在血管内移动来使不同功能(血液抽出和血液送回)的流体动力最优化。由于流入(inflow)和流出内腔间分开更大，在分裂末端导管的抽出和送回内腔间引入角度可以进一步减小通路再循环的可能性。
此外，可以期望具有最大可能的内腔截面面积来使导管流动特性最优化并且还随时间的推移维持适当的流量，因为诸如导管凝结等因素流动速度会趋于降低。然而，留待解决的是需要保持导管适当的物理和机械性能(例如抗拉强度以及抗扭结性)以及维持导管整体尺寸足够小来实现插入和适合的生理功能。考虑到这些约束，对内腔或分裂末端段中的一个或另一个而言，具有不同的形状(例如更大的内腔截面)是有利的，例如有利于便利血液回收或分散返回的清洗过的血液。特别地，动脉(或抽出)内腔更容易堵塞而且可以收益于具有更大的截面。然而，使用传统的制造技术难以将这样的几何差异结合到分裂末端导管中。
尽管已知各种用于制造分裂末端导管的技术，仍存在对更有效的和更坚固耐用的技术的需求，特别是，当对内腔或末端段中的一个或另一个而言，末端元件以一角度的分又是期望的或不同形状或几何造型是期望的时，存在对制造这样的分裂末端导管的需求。
发明内容
公开了具有至少一个分裂端的多内腔导管设备，以及形成这样的分裂末端导管的方法。在本发明的一个方面，制造方法可以包括以下步骤：提供导管本体，所述导管本体具有纵向延伸通过所述导管本体的至少第一和第二内腔；去除所述导管本体的一远侧部分来形成第一远侧末端段，以致所述第一内腔在这一末端段内纵向延伸超过所述第二内腔；以及将第二内腔末端段以与所述第二内腔连通的方式接合到所述导管本体。所述第二末端段可以被接合到所述导管本体，以致所述第二末端段至少部分地与所述第一末端段分开，并且在某些实施方案中，优选地相对于所述第一末端段以一角度分叉。
所述第二内腔末端段可以通过各种技术被接合到所述设备。例如，所述第二段可以通过热或化学熔合被接合到所述导管本体。可替换地，所述第二内腔末端段可以利用粘合剂或类似物被结合到所述导管本体。
在本发明的一个实施方案中，可以定向所述第二内腔末端段，以致所述第一和第二末端段是分开的并且以一角度相互分叉。可以在所述第二末端段被接合到所述导管本体之前、过程中或之后，形成在所述第一和第二末端段间的所述角度。例如，可以在通过应用热将所述段接合到所述导管本体后形成所述角。可替换地，所述导管本体和/或所述第二段可以呈现一成角度的界面，以致在接合点处自己形成一角度。在所述第一和第二末端段间的所述角度可以从所述第一和第二末端段的近侧端变化到所述第一和第二末端段的远侧端，例如，分开的末端段中的一个或两个可以为复合角或被形成简单或复合曲线的形状。
在本发明的另一实施方案中，所述第二内腔末端段可以被定向，以致所述第一和第二末端段是分开的，但基本上相互平行。
根据本发明的分裂末端导管，可以以切去内腔中的一个的方式，通过去除所述导管本体远侧的一部分来形成。如果成角度的分开是期望的，所述方法还可以包括以相对于所述导管本体的纵轴非垂直的方式修剪(trim)所述内腔来便利所述第二末端段以一角度的附接。可替换地，如果基本上平行的分裂末端是期望的，所述方法还可以包括在基本上垂直于所述被修剪的内腔的纵轴的方向修剪所述内腔。
本发明的所述导管还可以包括在所述末端段的至少一个的一侧形成流体通孔。在另一方面，本发明的所述导管还可以包括具有抗血栓试剂(例如肝素)的在所述导管本体的至少一部分或所述第一和/或第二末端段上的涂覆层，以减少血凝结或蛋白黏着。在其他方面，本发明的所述导管可以包括具有抗菌试剂和/或消炎试剂的在所述本体的至少一部分或所述第一和/或第二末端段上的涂覆层。
此外，在所述分裂末端导管的形成之后(或形成期间)，所述第一和第二末端段可以利用生物可吸收粘合剂接合在一起来简化脉管插入。插入之后，所述末端段可以在一旦粘合剂溶解时分开，例如经过一段范围从1秒至数日的时间，更优选地，从约1分钟至约10小时或5小时或一小时。
在本发明的另一方面，公开了形成分裂末端导管的方法，所述方法包括以下步骤：(a)提供多内腔导管本体，所述多内腔导管本体具有延伸通过所述导管本体的至少第一内腔和第二内腔；(b)部分地截切所述多内腔导管本体的远侧端来形成第一远侧内腔管体，以致所述导管的所述第一内腔在所述第一远侧管体内，纵向延伸到比所述导管的至少第二内腔更远；以及(c)将第二内腔管体附接到所述导管的所述被切断的端，以致形成与所述导管的所述第二内腔流体连通的第二远侧内腔管体，并且所述第二远侧内腔管体以与所述第一远侧内腔管体分开的方式从所述导管纵向延伸。
所述方法还可以包括在所述第一远侧管体和所述第二远侧管体间形成非零度角。例如，可以通过以一角度(例如以相对于所述第一远侧内腔管的纵轴非垂直的方式)修剪所述导管本体，并且然后在这一位置将所述第二远侧管体熔合或结合到所述导管本体，来形成非零度角。在此，术语“熔合(fusing)”和“结合(bonding)”是可互换使用的，并且在使用中，两个术语均意图包含热熔合、熔化结合、超声波焊接、化学结合、粘合剂结合以及类似的工艺。
可替换地，可以以基本上零度角的分叉形成所述第一和第二远侧端管体，例如所述两端段在静止位置是基本上相互平行的。例如，可以通过以相对于所述第一远侧内腔管体的纵轴垂直的方式修剪所述导管本体，并且然后在这一位置将所述第二远侧管体熔合或结合到所述导管本体，来形成零度角。
在某些实施方案中，可以优选的是，所述第二远侧管体(其将被接合到所述导管本体)在所述导管本体内具有不同于所述第二内腔的内腔截面，或者所述第一和第二内腔在所述导管本体内具有彼此不同的内腔截面。本发明也适用于具有三个或更多个内腔的导管。例如，三内腔导管本体可以被截切，以致只有一个远侧内腔从截切点延伸并且然后两个分开的端管体可以被接到所述本体上来提供三个独立的远侧末端段。可替换地，所述两个嫁接的段可以被连接在一起，但是以与所述第一段(由所述原始的导管本体形成的)分开的方式接合到所述本体。在另一可替换实施方案中，所述三内腔导管本体可以被截切，以致所述内腔中的两个在远侧段中从所述截切点延伸，其中一分开的端管体被嫁接接到所述本体上以提供分开的第三内腔。
除了其他原因以外，本发明的有益之处在于因为只有一个远侧末端段被结合到所述导管本体(与现有技术中必须有两个末端段被结合形成对照)，因而简化工艺并且缩短制造时间。进一步的益处在于，结合单个远侧末端段允许减小在所述导管本体中的隔膜厚度(并且因此增加了内腔的截面)，因为所述隔膜无需适应两个分开的远侧端管体的附接。
当所述内腔中的一个或更多个具有非圆形截面(例如基本上为D形截面)时所述方法特别有用。例如，所述导管本体可以以“双D”结构的方式形成，具有双“D”形的内腔背靠背并且由隔膜分开。可以通过各种方式形成在所述内腔间具有隔膜的导管本体，例如，通过挤压成形一体的本体，或通过组装两个D形的单一内腔元件并且然后由热缩的聚合物材料的鞘包围这两个单一内腔元件，从而形成一体的本体。
根据本发明的所述方法还可以包括部分地截切所述导管本体的步骤，所述步骤还包括在截切点截切所述本体，以致所述隔膜的至少一部分(并且优选的为所述隔膜的一大部分或全部)由所述第一远侧内腔管体保持。此外，所述方法还可以包括至少部分地将所述第二远侧管体附接到所述第一远侧管体的所述隔膜。
根据本发明的所述方法还可以包括附接具有不同于所述导管本体的所述第一或第二内腔的形状的第二远侧管体的步骤。(在本文，使用术语“形状”来包含几何造型上的不同，例如，圆形、椭圆形或D形，以及尺寸的不同，例如所述内腔的截面面积。)
在本方面的另一方面，公开了形成分裂末端导管的方法，其中所述方法可以包括以下步骤：(a)在分隔所述内腔中的两个的隔膜处截切所述导管本体，以致形成第一远侧端管体并且所述第一管体围绕第一内腔，所述第一内腔所具有的长度延伸超过截切点；以及(b)将第二远侧端内腔管体以与所述导管本体的第二内腔流体连通的方式附接到所述导管本体。
在本发明的又另一方面，公开了形成分裂末端导管的另一种方法，所述方法包括以下步骤：(a)去除被包括在导管本体内的一内腔的部分长度来使在所述内腔和被包括在所述导管本体内的另一内腔之间的隔膜显露出来，其中每一内腔限定纵向延伸通过所述本体的分开的流体通道；以及(b)在所述导管本体的远侧端附接替换内腔管体，以致纵向延伸通过所述替换内腔管体的通道与已被部分地去除的所述内腔的所述通道连通。再有，可以以一角度分叉或保持相互平行来形成所述双(或更多)内腔管。(如在本文所使用的，术语“平行”是意图包含名义上具有“零度”分叉角的结构，以及具有由于实际约束或加工公差而会存在的小角度的结构。也可以理解的是，用于本发明的所述导管的所述优选的材料为聚合材料，例如聚氨酯或硅氧烷，所述材料在其平行和分叉两种结构中也均将呈现柔韧性或“松软性”。)
去除所述内腔的部分长度的步骤还包括以对于垂直于所述导管的纵轴的轴成零度角或非零度角修剪所述内腔开口。将被接合到所述导管本体的所述替换内腔管体的所述端也可以以一角度地切割。
在本发明的又一方面，公开了分裂末端导管的形成方法，所述方法包括以下步骤：(a)提供多内腔的导管本体，所述多内腔的导管本体具有延伸通过所述导管本体的至少第一内腔和第二内腔；(b)部分地截切所述多内腔导管本体，以致形成第一远侧内腔管体来使所述导管的所述第一内腔纵向延伸到比所述导管的至少所述第二内腔更远；以及(c)将第二内腔管体附接到所述导管的所述被截切的端，以致以与所述导管的所述第二内腔流体连通的方式形成与所述第一远侧管体分开的通道，其中所述第一内腔具有不同于所述第二内腔的形状。
在本发明的再一方面，公开了分裂末端导管设备。在一个实施方案中，所述分裂末端导管可以包括导管本体；被包括在所述导管本体内的第一内腔，所述第一内腔具有纵向延伸通过所述导管本体的内部通道；被包括在所述导管本体内的第二内腔，所述第二内腔具有纵向延伸通过所述导管本体的内部通道和小于所述第一内腔长度的长度；以及被附接到所述第二内腔的内腔末端段，并且所述内腔末端段具有纵向延伸通过所述内腔末端段的通道，以致所述内腔末端段的所述通道与所述第二内腔的所述通道连通。
可以形成根据本发明的导管设备，以致所述内腔末端段中的一个的至少一部分是由不同于所述导管本体材料的材料构成。在某些实施方案中，所述第一内腔和所述内腔末端段是分开的并且在所述导管本体的远侧端以一角度相互分叉。在其他实施方案中，所述第一内腔和所述内腔末端段是分开的，但基本上相互平行。
在又另一实施方案中，公开了分裂末端导管设备，所述设备包括导管本体；与所述导管本体为一体的第一远侧末端段，所述第一远侧段具有纵向延伸通过所述导管本体的第一内腔的内部通道；以及与所述第一远侧段分开并且被接合到所述导管本体的第二远侧末端段，所述第二远侧末端段提供自所述导管本体的第二内腔的流体通道并且所述流体通道纵向延伸通过所述第二末端段。
由下面的说明书和权利要求书，其他优点和特征将变得清晰。
附图说明
结合附图，由下面详细的说明书，本发明将被更加完整地了解，在全部的附图中类似的编号标示类似的部分，并且其中：
图1为根据本发明的导管的部分被切去的侧视示意图；
图2为本发明的实施方案的截面视图，示出在外鞘内由相对的D形内腔本体形成的导管构造；
图3为本发明的实施方案的截面视图，示出使用相对的D形内腔的一体式(unibody)导管构造；
图4为本发明的实施方案的变体的截面视图，示出不同截面面积的相对的D形内腔；
图5为本发明的实施方案的截面视图，示出又另一具有不同形状和尺寸的内腔的一体式构造；
图6为本发明的实施方案的截面视图，示出在外鞘内由两个独立的圆形内腔形成的一体式构造；
图7为本发明的实施方案的截面视图，示出具有两个独立的圆形内腔的一体式构造；
图8为本发明的实施方案的截面视图，示出具有三个内腔的一体式构造；
图9为本发明的实施方案的变体的截面视图，示出具有三个内腔的一体式构造；
图10为本发明的实施方案的截面视图，示出椭圆形的一体式构造；
图11为根据本发明的导管在原始的、未修剪的构造的透视示意图；
图12为另一导管在原始的、未修剪的构造的透视示意图；
图13为本发明的实施方案的透视示意图，示出修剪后的导管；
图14为本发明的实施方案的变体的透视示意图，示出修剪后的导管；
图15为本发明的实施方案的透视示意图，示出附接到导管的内腔管体；
图16为本发明的实施方案的变体的透视示意图，示出附接到导管的内腔管体；
图17为本发明的实施方案的变体的透视示意图，示出附接到导管的内腔管体；
图18为本发明的实施方案的变体的透视示意图，示出附接到导管的内腔管体，其中所述内腔管体被附接到所述隔膜的至少一部分；
图19为本发明的实施方案的变体的透视示意图，示出附接到导管的内腔管体，其中所述内腔管体以可替换的方法被附接到所述隔膜的至少一部分；
图20为本发明的实施方案的透视示意图，示出粘合剂的应用；
图21为本发明的另一实施方案的远侧截面视图，示出可替换的粘合剂的布置；
图22为又另一粘合剂设计的远侧截面视图；
图23为本发明的实施方案的透视示意图，示出在所述远侧末端的流体开口；
图24为本发明的实施方案的变体的截面视图，示出修剪后的导管；
图25为本发明的实施方案的变体的截面视图，示出另一修剪后的导管；以及
图26为根据本发明的导管的侧视示意图；
具体实施方式
在图1中示出根据本发明的分裂末端导管100的实施方案，分裂末端导管100具有含有两个内腔104a、104b(共同地称为内腔104)的导管本体102。内腔104分别包括纵向延伸通过导管本体102的内腔通道106a、106b(共同地称为通道106)。导管本体102具有分裂末端的远侧端108，在远侧端108中导管本体102(以及内腔104)分开成两个远侧内腔末端段110a、110b(共同地称为内腔末端110)。一个内腔104b已被修剪为长度小于另一内腔104a。内腔末端段114已经被接合到被修剪后的内腔104b，以致内腔末端110b包括内腔末端段114，并且以致内腔末端段114与被修剪后的内腔10b流体连通。内腔末端110b相对于另一内腔末端110a形成角α。α的值可以为零度或非零度并且优选地在零度到九十度的范围内。内腔末端110可以，但不是必需，具有一个或更多个与其各自的内腔104流体连通的流体通孔112a、112b(共同地称为流体通孔112)，以便利流体移出(典型地通过内腔104b)和送回(典型地通过内腔104a)，例如，在血液透析过程中的血液移出和送回。可替换地，或者结合流体通孔112，内腔104的一个或两个远侧端116a、116b(共同地称为远侧端116)可以是敞开的，以(例如，为血液的移出和送回)提供通过通道106的流体通道。导管本体102的近侧端118也可以被分裂为分开的段118a、118b并且以两个进入端口120a、120b终止，端口120a、120b可以包括耦接器，例如鲁尔锁定器(Luer-lock)或类似的耦接器，以将导管100耦接到对血液进行循环并净化的血液透析机。典型地，导管本体102是很柔韧的硅氧烷、聚氨酯或其他生物相容的组合物(例如，具有在约65至约85硬度单位(durometer)的范围内的硬度)，并且可以包括任何类型的导管(例如血液透析导管或中心静脉导管)。
导管本体102可以包括部分地或全部地覆盖和封闭内腔104的外鞘122。外鞘122可以为任何形状和尺寸，并且可以由与内腔104相同的材料或其他适合插入血管的材料制成。如在这一实施方案中所图示说明的，外鞘122邻近于内腔104的远侧端116终止，以致每一内腔104的内腔末端110是分开的或在被插进血管后可以彼此分开。
图2示出外鞘122的一个实施方案的沿c1-c1的截面。外鞘122可以具有任何厚度并且可以具有变化的内外形状，以及变化的内外尺寸。导管本体102可以被这样构造，以致鞘材料200包住内腔104a和104b，并且在所述鞘和所述内腔间没有留空间。例如，所述鞘可以被熔合到所述内腔或被热缩围绕所述内腔。
内腔104可以具有各种截面形状和尺寸，但优选地，如图1中所示的实施方案，导管本体102具有基本上为椭圆的(圆或椭圆)形状并且内腔104的每一个均是D形的。然而，内腔104中的一个或两个都可以沿着其长度的至少一部分从一个形状过渡到另一个，例如从D形截面过渡到圆形截面。此外，如图3-10中所示的沿c2-c2的截面的实施例，内腔104中的每一个均可以具有与导管本体102和/或另一个内腔相同或不同的截面形状、尺寸或面积。
图3是实施方案的截面视图，示出使用相对的D形内腔104的一体式构造，内腔104具有基本上与通道106相同的尺寸。这一结构消除了作为不同元件的鞘。图3的所述设备可以通过挤出成形例如具有多个整合于其内的内腔的导管本体来形成。根据本发明的一个实施方案，可以通过使所述本体沿所述纵轴的中心线γ或沿偏心纵轴γ′分裂，来截切导管本体102的所述端部分。在某些应用中，可以优选沿偏心线γ′截切，因为这在牺牲另一内腔104a的部分(例如，如图1中所示的，超过切点124向远侧延伸的所述部分)的同时，保留绝大部分或全部的隔膜202。
图4为另一实施方案的截面视图，示出相对的D形内腔104，其中一个内腔104a比另一个内腔104b的尺寸更小(例如，更小的截面面积)。图5为实施方案的截面视图，示出又另一一体式构造。图6为实施方案的截面视图，示出在外鞘122内的分开的椭圆形内腔。图7为实施方案的截面视图，示出使用分开的椭圆形内腔104的一体式构造。图8为实施方案的截面视图，示出三个内腔104，三个内腔中的至少一个(在此，内腔104c)具有与至少一个其他内腔(在此，内腔104a、104b)不同的尺寸和/或形状。图9为实施方案的变体的截面视图，示出三个基本上具有相同尺寸和形状的内腔104。图10为另一实施方案的截面视图，示出两个椭圆形状的内腔104。
内腔104可以由任一生物相容的材料制成，包括允许内腔104的内腔末端110、114为柔韧的而便利血液透析的任一材料。此外，内腔末端段114可以由不同于被切的内腔104b材料的材料制成。所述不同的材料可以为一种或多或少比被切的内腔104b的材料要柔韧的材料。针对内腔末端段114和被切的内腔104b使用不同材料，可以允许导管本体102被更有效地使用，或者，被完全使用于这样的应用中，其中在远侧端116b处具有被切的内腔104b的材料是非优选的或不可能的。
每一内腔104的远侧的抽出和送回末端部分110包括形成在内腔104中的通道106，用于血液或其他体液的抽出和送回。尽管通道可以为任何尺寸并且导管100可以被用于任何应用中，优选地，通道106被选择尺寸来允许血液被运送到血液透析单元或从血液透析单元被运送出。远侧的抽出和送回末端部分110可以为相同的长度，或如下面进一步讨论的，可以为不同的长度。
参考图11-26，描述了形成分裂末端导管的示例性方法。尽管参考这些附图(以及图1-10中相关的数幅)进行描述，这一方法(或类似的方法)可以被实施来形成文本所描述的任一所述分裂末端导管设备。
图11示出具有双“D形”内腔104a、104b的、原始未被修剪结构(例如，没有分开的远侧末端段)状态的圆形导管本体102。图12示出另一原始结构状态(例如，在第二远侧内腔末端段114的修剪和接合之前)的具有圆形内腔104a、104b的椭圆形的导管本体102。尽管内腔104在图12中被图示为具有相同的长度，内腔104在这一原始结构时可以具有不同的长度。
图13示出被修剪后结构状态的导管本体102，其中相比于图11或12中的原始结构，导管本体102的远侧部分已经被去除。也可以通过使内腔104a、104b在参差的阶梯状结构下延伸的方式来形成图13中的导管本体102，以致内腔中的一个104a比另一个内腔104b延伸远出长度L1。在热时内腔104a、104b可以以这种方式调准，并且当内腔104a、104b冷却时可以以这一结构结合在一起。然而，以这种结构被形成，内腔中的一个104a(在此，被称为“未被切的内腔104a”)纵向延伸超出另一内腔104b(在此，被称为“被切的内腔104b”)一长度L1。在原始结构中，例如在这一实施方案中，其中内腔104原始地具有相等的长度，长度L1与从被切的内腔104b修剪下的内腔的量相等。优选地，长度L1可以在约1-3英寸的范围内，但这仅是要修剪的内腔长度的实施例。
被牺牲的内腔104a可以以各种方式修剪。在优选的实施例中，内腔中的一个104b可以横向地穿过其圆周在位置124处而被切开(例如，切割或刻划)。然后，被切的内腔104b的长度L1可以从导管本体102被修剪掉。当被切的内腔104b的长度L1已经被去除，在被切的内腔104b和未被切的内腔104a间的隔膜可以由此被至少部分地显露出来。
再次参考图4，其中一个内腔104a比另一个内腔104b更小，典型地，较大的内腔104b是动脉内腔，因为动脉内腔是内腔104中更易于在血液透析设置中产生阻塞的一个，而较大尺寸的通道106b可以帮助减少阻塞。典型地，根据本发明的所述端部分的截切包括牺牲较大的内腔104b的一部分以及将新的远侧末端段接合在所述部分的位置。可以还是沿偏心纵轴γ′使导管本体102分裂，从而保留隔膜202的大部分或全部，牺牲内腔104b的一部分(例如，向远侧延伸超过切点124的部分)。截切之后，则可以将新的远侧末端段114(如图1所示)接合到所述导管本体的所述第二内腔。远侧末端段114可以为与所述牺牲的内腔具有相似的尺寸和形状或可以为不同的尺寸和/或形状。
在某些应用中，可以优选地改为牺牲较小的内腔104a。在这样的情况下，所述截切线可以移动到隔膜202的另一侧。
内腔104a和104b的尺寸可以在实施方案间变化。在这一示例实施方案中，尺寸允许导管本体102与标准的血液透析仪器和内腔末端段一起使用。较小内腔通道106b的最大宽度w2约为0.06英寸，并且较大内腔通道106a的最大宽度w1约为0.08英寸。隔膜202具有约0.02±0.002英寸的宽度w3，而内腔104具有约0.022±0.003英寸的外部宽度w4。较小的通道106a的最大高度h2约为0.14英寸，并且较大通道106b的最大高度h1约为0.15英寸。
可以以相对于被切的内腔104b的纵轴β垂直或非垂直的方式修剪被切的内腔104b的被切的远侧端124。图13示出以相对于轴β垂直的方式修剪被切的远侧端124。可替换地，图14示出以相对于轴β非垂直的方式修剪被切的远侧端124。所述非垂直方式可以导致被切的远侧端124和轴β间的任何非零度的角θ。如图13和14所示，血液抽出内腔104b的远侧抽出末端部分110b的终止邻近于血液送回内腔104a的远侧送回末端部分110a。然而，如图15所示的，还包括附接到远侧末端送回部分110b的内腔末端段114，两个远侧内腔末端段110具有相同的长度，尽管即使包括了内腔末端段114，内腔末端110中的一个或另一个可以比另一个更长。
导管本体102的一远侧部分被移除，如图15所示，内腔末端段114就可以被接合到导管本体102。内腔末端段114已经被接合到被切的内腔104b在被切的远侧端124处的内腔末端110b，以致被切的内腔104b的通道与内腔末端段114连通，由此通过被切的内腔104b和内腔末端段114形成单一通道106b。
可以通过各种方式将内腔末端段114附接到导管本体102。例如，内腔末端段114可以被熔合到内腔末端110b的被切的远侧端124。可以使用任何熔合技术，例如热熔合，其中将被接合的元件(在此，内腔末端段114和内腔末端110b)被沿其外周或其他区域的任一或所有部分加热，以达到期望的温度，以及通过应用期望的力或通过在另一个内腔上插入一个内腔(例如，通过约1cm的重叠)并允许它们一起熔化/冷却而被熔合到一起。在另一实施例中，内腔末端段114可以被结合到内腔末端110b被切的远侧端124。可以使用任何结合技术，例如向将被结合的所述元件中的一个或更多个施加诸如粘合剂的结合材料，并且如果需要，加热所述结合材料以将其结合到所述部件。在某些实施方案中，内腔末端段114可以以这样的方式被附接，即以在导管本体102的内腔壁和内腔末端段114的内腔壁间提供逐渐过渡，例如通过插入心轴并且施加热。
可以以相对于被切的内腔104b的纵轴β成任一角度的方式来定向内腔末端段114。此外，内腔末端段114和内腔末端110a中的一个或两个可以相对于另一个末端在其长度的至少某些部分具有凸形状。例如，如图15所示，内腔末端段114可以以相对于轴β成九十度角θ′的方式被附接到内腔末端段110b。在这样的结构中，内腔末端110是分开的，但基本上互相平行。图16示出另一实施方案，在一成角度的分裂末端结构中(例如，如在美国专利第6482169号中所描述的，由此通过引用将其全部内容并入本文)，其中内腔末端110是分开的，并且基本上相互平行。可替换地，如图17所示，可以以小于九十度的角度θ′将内腔末端段114定向到被切的内腔104b。在这样的结构中，内腔104是分开的并且以一角度σ相互分叉。当角θ′小于九十度时，这典型地在被切的远侧端124已经被以相对于轴β非垂直的方式修剪的结构中，并且当内腔末端段114被接合到被切的内腔104b的同时，形成角σ。然而，可以在内腔末端段114已经被接合到被切的内腔末端110b之后形成角σ，例如，通过施加热。在另一实施例中，图17中的设计可以通过首先将内腔末端段114附接到被切的内腔末端110b，并且然后加热内腔104来形成角σ而形成。可替换地，诸如图17中的内腔末端110可以具有这样的原始结构，其中二者相对于轴β成一角θ′。
角σ的顶点可以如图17所示，被定位在被切的内腔104b和内腔末端段114的接合处，或更接近导管本体102的远侧端。在角σ更接近导管本体102的远侧端的情况下，如图18所示，内腔末端段114可以沿未被切的内腔104a的长度L5被结合到所述隔膜。可替换地，如图19所示，内腔末端段114可以沿未被切的内腔104a的长度L5被结合到所述隔膜，并且以一角度θ′被附接到被切的内腔104b。典型地，在这些和其他实施方案中，内腔末端段114也可以在与被切的内腔104b的接合处沿所述圆周被结合。
无论是否基本彼此平行或彼此分叉，内腔104是分开的(至少在任何粘合剂的应用前，下面进一步讨论)。图17示出内腔104分开一长度L1，而图18示出内腔104分开长度L4。图17也示出一实施方案，其中内腔104中的一个比另一个更长，内腔末端110a的远侧端116a延伸超出内腔末端段114的远侧端116b一长度L3。
再次参考图15，在这一实施方案中示出的内腔104是基本上平行的，并且长度L1可以以粘合剂1600固定在一起。在导管本体102的远侧端116被插入血管之前，可以利用生物可吸收的粘合剂1600将内腔104的内腔末端110的全部的或部分彼此接合。在插入到血管之后，生物可吸收的粘合剂1600便利内腔104的内腔末端110的分开。如在此使用的，术语“生物可吸收的”涉及生物可降解的或生物可溶解的材料，以致由机械降解和生理环境的共同作用而在一段时期内被降解或分解为可代谢的或可排泄的组分。
用来将内腔104的内腔末端110彼此接合的生物可吸收的粘合剂1600可以为组合物，所述组合物选自由聚交酯、聚乙交酯、聚内酯、聚原酸酯、聚酸酐及其共聚物和其组合组成的聚合物的组。通常，生物可吸收的粘合剂具有结合要素(elements)和可降解要素。所述可降解要素可以具有聚交酯、聚乙交酯以及聚内酯(聚己酸内酯)的组分。所述结合要素可以具有氢键合强度(聚乙烯醇、多糖)或可以作为单一组分(氰基丙烯酸酯)或两种组分(环氧化合物加氨基化合物，或丙烯酸酯化合物的自由基(光)引发剂)能够聚合。
蛋白质、糖以及淀粉也可以被用作粘合剂。通过非限制性实施例的方式，诸如肝素和水蛭素、柠檬酸盐、抗凝血酶-肝素复合物，以及白蛋白肝素复合物的抗血栓试剂，诸如氯己啶、银、抗生素的抗感染试剂，以及防腐试剂可以被加到所述粘合剂中。
在本发明的一实施方案中，可以有用的聚合物包括聚氨酯，一般地被描述为具有聚乙二醇与由甲基丙烯酸酯封端的聚交酯或聚乙交酯的共聚物。另一实施方案可以包括两种组分的组合物，一种组分优选地包括低分子量的甲基丙烯酸酯封端的聚氨酯，以及另一种组分优选地包括甲基丙烯酸酯封端的聚交酯、聚乙交酯或末端聚己酸内酯。
在本发明的另一实施方案中，当水、有机溶剂，例如二氯甲烷、氯仿、四氢呋喃、丙酮、石油醚、乙酰基乙酸酯、二甲基甲酰胺(dirnethylformamide)或其混合物与前面所述的溶剂合并时，来自苯乙烯、甲基丙烯酸甲酯、丙烯酸甲酯、二甲基丙烯酸乙二醇酯、二丙烯酸乙二醇酯、丙烯酰胺(acrylarnide)、二脲烷二甲基丙烯酸酯、聚异戊二烯接枝马来酸单甲酯、偶氮双(氰基戊酸)、偶氮双环己烷甲腈、偶氮双异丁腈、过氧化苯甲酰、硫酸亚铁、聚乙烯醇、葡聚糖、多糖、表氯醇、乙二胺、二氨基环己烷、二氨基丙烷、以聚交酯和聚氧化乙烯作为嵌段并且丙烯酸酯，甲基丙烯酸酯作为端基的共聚物、氰基丙烯酸酯、2氰丙烯酸乙酯、2氰丙烯酸丙酯、2氰丙烯酸戊酯、2氰丙烯酸己酯以及2氰丙烯酸辛酯、过硫酸铵和/或聚乙二醇甲基丙烯酸酯中的一种或更多种组分可以被使用。
如图15所示，所述生物可吸收的粘合剂1600可以沿内腔104的内腔末端110之一或两者的相面对的表面(facing surface)，来在导管本体102的远侧端116插入血管之前，便利内腔末端110沿其纵向长度的接合。(如在全文中所用到的，“导管本体102”及其部件涉及本发明的各种实施方案。)图15示出沿纵向长度L1施加的生物可吸收的粘合剂1600。然而，无需沿每一内腔104的相面对的表面的全部长度施加生物可吸收的粘合剂1600，但是，优选为这样地施加，即以致粘合剂1600在插入血管之前便利内腔104的内腔末端110的接合并且在插入后允许内腔104的内腔末端110分开。此外，可以沿比长度L1更长的长度施加生物可吸收的粘合剂1600，例如，内腔104若已被分开一附加长度L2，在这种情况下，可以沿与L1+L2相等的长度施加粘合剂1600。
在图20所示的实施方案中，可以以离散的点或区域2000的方式在内腔104的内腔末端110的相面对的表面施加生物可吸收的粘合剂。(假设在这一实施例中，内腔末端段114已经被附接到被切的内腔末端110b。)所述生物可吸收的粘合剂的点2000可以沿内腔104的内腔末端110的全部纵向长度被连续地施加或被可选地施加在内腔末端110的纵向长度的一种类型的区域中。优选地，所述生物可吸收的粘合剂被这样施加，以致粘合剂的点2000在插入血管之前便利内腔104的内腔末端110的接合，并且在插入后允许内腔104的远侧抽出和送回末端110分开。生物可吸收的粘合剂的点2000可以在数目、尺寸以及彼此的距离上变化，以便利内腔104的内腔末端110的接合和/或分开。
在本文所描述的实施方案中，优选地，所述生物可吸收的粘合剂在插入血管后溶解，以在一分钟到一小时的范围内的时间段中(但长达数日或更久)提供内腔104的内腔末端110的分开。可以通过使用所述生物可吸收的粘合剂不同组合物，以及使内腔104的内腔末端110接合在一起所施加的粘合剂的量来控制所述范围。在具有相对的远侧流体开口112(下面进一步描述)的另一实施方案中，所述生物可吸收粘合剂可以为水溶性的，以致盐水或相似类型的流体的引入将实现内腔104的内腔末端110的分开。在这种情况下，所述溶性的溶液引入内腔104后的一段时间后，所述生物可吸收的粘合剂才将溶解。
图21-22示出了详细描述所述生物可吸收的粘合剂应用可替换实施方案的内腔104的内腔末端110的截面。图21和22示出被施加在内腔104的所述相面对的表面的接触点(contact point)402的生物可吸收粘合剂400。图21示出生物可吸收的粘合剂400的施加的一个实施方案，以致如此施加的粘合剂400使内腔104的内腔末端110的非接触表面2100、2102接合。图22示出图21中所示的实施方案的变体，其中生物可吸收的粘合剂400围绕内腔104的内腔末端110而形成粘合剂涂覆层的连续截面，虽然内腔104的内腔末端110仍然从中延伸穿过。如上所述的，无需沿内腔104的内腔末端110的全部长度施加生物可吸收的粘合剂400，但是优选这样地施加，即以致粘合剂400在插入血管之前便利血液抽取和血液送回内腔104的远侧抽取和送回末端部分110的接合，并且在插入后允许内腔104的内腔末端110分开。此外，内腔末端110可以具有不同于彼此的涂覆层和/或不同于导管本体102上的涂覆层。
图23示出另一实施方案，其中远侧流体开口(也被称为流体通孔)112a形成在内腔104a的内腔末端110a中。从附图中可以理解，在所示出的实施方案中，远侧流体开口112a可以附加于或取代位于内腔104a的远侧端106a的通道开口而存在。此外，被切的内腔104b可以具有相似于本文所描述的远侧流体开口112b，从而流体开口112b将典型地被包括在附接到被切的内腔末端110b的内腔末端段114中，或在其附接到被切的内腔末端110b后，形成在内腔末端段114中。
远侧流体开口112a可以为任何形状和尺寸，并且可以被定位在内腔104a上的各种地方。图23示出远侧流体开口112a被定位在内腔104a的内腔末端110a的相面对(接触)表面2300上。在这一实施方案中，远侧流体开口112a可以被流体激活生物可吸收的粘合剂填充或覆盖，并且沿其相面对的表面2302被接合到另一内腔104b。在导管本体102插入血管后，盐水或相似类型的流体可以在内腔的近侧端118处被引入内腔104a，以致所述流体经过内腔104a到远侧流体开口112a并且溶解所述流体激活生物可吸收的粘合剂，从而沿其纵向长度将内腔末端110分开来，例如，便利血液透析。除了远侧流体开口112a被流体激活生物可吸收的粘合剂填充或覆盖之外，生物可吸收的粘合剂还可以如之前上面所描述的，被施加到每一内腔104的接触面2300、2302。
图1-7和11-23图示说明双内腔结构，但本文所描述的所述分裂末端导管设备及方法可以应用到任何多内腔的结构。例如，图24示出具有三个内腔104a、104b、104c的导管本体2400的实施方案，每一内腔具有各自的通道106a、106b、106c。导管本体2400可以具有任一沿c1-c1的截面结构，并且在这一实施例中，被示出具有图9中的截面结构。这一实施例中的内腔中的一个104a已经被从其他内腔104b、104c切开，并且内腔104a已经被修剪。图25示出图24的导管本体2400，其中第二内腔104c已经被从另一内腔104b切开并修剪。内腔末端段2500已经被接合到第一被修剪的内腔104a，并且另一内腔末端段可以被附接到第二被修剪的内腔104c。
上述实施方案描述导管的分裂远侧端，但除了分裂所述远侧端或取代于分裂所述远侧端，所述近侧端也可以相对于所述远侧端，以上面所描述的任一方式被形成为分裂末端结构(例如，双分裂末端或“双Y”形结构)。这样的结构在倒插入或反向插入中可以是有用的，其中所述导管本体从静脉切开放血部位经过皮下隧道到远的出口位置。在隧穿所述导管后，流体耦接器或其他附接物可以被放置到所述内腔的所述近侧端。图26示出具有分裂远侧端2602和分裂近侧端2604的导管本体2600。套箍2606可以被附接到导管本体2600的任一位置来加强组织内生。所述导管可以具有任何尺寸，但仅作为实施例，导管本体2600可以具有约38cm的长度L5，在远侧端2602的远侧最终端2608和套箍2606间的长度L6可以为约23cm，以及在远侧最终端2608和被切的近侧端2610间的长度L7可以为约28cm。
其他实施方案落入所附的权利要求书的范围内。
本申请所涉及的所有公开文件、专利文件以及其他信息源均通过引用被并入本文。

Claims (50)

1.一种形成分裂末端导管的方法，所述方法包括：
提供细长的导管本体，所述导管本体包括纵向延伸通过所述导管本体的至少第一内腔和第二内腔；
去除所述导管本体的一远侧部分来形成第一内腔末端段，以致所述第一内腔纵向延伸超过所述第二内腔；以及
将第二内腔末端段以与所述第二内腔连通的方式接合到所述导管本体。
2.如权利要求1所述的方法，其中所述接合第二内腔末端段的步骤还包括将所述第二段熔合到所述导管本体。
3.如权利要求1所述的方法，其中所述接合第二内腔末端段的步骤还包括定向所述第二段，以致所述第一和第二末端段是分开的，但基本上相互平行。
4.如权利要求1所述的方法，其中所述接合第二内腔末端段的步骤还包括定向所述第二段，以致所述第一和第二末端段是分开的并且以一角度相互分叉。
5.如权利要求1所述的方法，还包括在所述第二末端段被接合到所述导管本体之后，在所述第一和第二末端段之间形成一角度。
6.如权利要求5所述的方法，其中所述第一和第二末端段中的至少一个形成复合角或曲线。
7.如权利要求5所述的方法，还包括通过施加热在所述第一和第二末端段之间形成一角度。
8.如权利要求1所述的方法，其中所述去除所述导管本体的一部分的步骤还包括以相对于所述导管本体的纵轴非垂直的方式部分地切开所述导管本体。
9.如权利要求1所述的方法，还包括在所述末端段中的至少一个的一侧形成流体通道孔。
10.如权利要求1所述的方法，还包括用生物可吸收粘合剂将所述第一和第二末端段固定在一起。
11.如权利要求1所述的方法，还包括用至少一种试剂来涂覆所述第一和第二末端段的至少一部分，所述至少一种试剂选自由抗血栓试剂，抗菌试剂和消炎试剂组成的组。
12.一种形成分裂末端导管的方法，所述方法包括：
提供多内腔导管本体，所述多内腔导管本体具有延伸通过所述导管本体的至少第一内腔和第二内腔；
部分地截切所述多内腔导管本体，以致形成第一远侧内腔管体来使所述导管的所述第一内腔的远侧端纵向延伸到比所述导管的至少所述第二内腔的远侧端更远；以及
将第二远侧内腔管体附接到所述导管的所述被截切的端，以致以与所述导管的所述第二内腔流体连通的方式形成与所述第一远侧管体分开的通道。
13.如权利要求12所述的方法，还包括在所述第一和第二远侧内腔管体之间形成非零度角。
14.如权利要求13所述的方法，其中所述非零角在所述第一和第二远侧内腔管体的至少一部分上变化。
15.如权利要求12所述的方法，还包括在所述第一和第二远侧内腔管体之间形成零度角。
16.如权利要求12所述的方法，还包括在至少一个远侧内腔管体和所述导管本体的纵轴之间形成非零度角。
17.如权利要求12所述的方法，还包括：
进一步截切所述导管本体的所述远侧端来分出第三内腔；以及
将第三远侧内腔管体附接到所述导管本体。
18.如权利要求12所述的方法，其中所述部分地截切所述导管本体的步骤还包括：在截切点截切所述本体，以致至少隔膜的一部分由所述第一远侧内腔管体保持。
19.如权利要求18所述的方法，其中所述附接所述第二远侧内腔管体的步骤还包括至少部分地将所述第二远侧管体附接到所述第一远侧管体的所述隔膜。
20.如权利要求12所述的方法，其中所述附接所述第二远侧内腔管体的步骤还包括附接具有不同于所述第一或第二内腔形状的第二远侧管体。
21.如权利要求12所述的方法，其中所述附接所述第二远侧内腔管体的步骤还包括：附接所述第二远侧管体，以致所述导管本体的内腔壁逐渐过渡到所述第二远侧内腔管体的内腔壁。
22.如权利要求12所述的方法，还包括通过以下步骤形成第二分裂端部分：
在所述导管本体的近侧端部分地截切所述多内腔导管本体，以致形成第一近侧内腔管体来使所述导管的所述第一内腔纵向延伸到比所述导管的至少第二近侧内腔更远；以及
将第二近侧内腔管体附接到所述导管的所述被截切的近侧端，以致以与所述导管的所述第二内腔流体连通的方式形成与所述第一近侧管体分开的通道。
23.一种形成分裂末端导管的方法，所述方法包括：
使具有两个或更多个内腔的导管本体的远侧端在分隔所述内腔中的两个内腔的隔膜处分裂，以分出第一远侧端内腔管体，
截切所述导管本体，以致形成所述第一远侧端管体并且所述第一管体围绕第一内腔，所述第一内腔所具有的长度延伸超过截切点；以及
将第二远侧端内腔管体以与所述本体的第二内腔流体连通的方式附接到所述导管本体。
24.一种形成分裂末端导管的方法，所述方法包括：
去除被包括在导管本体内的一内腔的部分长度来使在所述内腔和被包括在所述导管本体内的另一内腔之间的隔膜显露出来，其中每一内腔限定纵向延伸通过所述本体的分开的流体通道；以及
在所述导管本体的远侧端附接替换内腔管体，以致纵向延伸通过所述替换内腔管体的通道与被部分地去除的所述内腔的所述通道连通。
25.一种形成分裂末端导管的方法，所述方法包括：
提供多内腔的导管本体，所述多内腔的导管本体具有延伸通过所述导管本体的至少第一内腔和第二内腔；
部分地截切所述多内腔导管本体，以致形成第一远侧内腔管体来使所述导管的所述第一内腔纵向延伸到比所述导管的至少所述第二内腔更远；以及
将第二内腔管体附接到所述导管的所述被截切的端，以致以与所述导管的所述第二内腔流体连通的方式形成与所述第一远侧管体分开的通道，
其中所述第二内腔具有不同于所述第一内腔的形状。
26.一种分裂末端导管设备，所述设备包括：
导管本体；
被包括在所述导管本体内的第一内腔，所述第一内腔具有纵向延伸通过所述导管本体的内部通道；
被包括在所述导管本体内的第二内腔，所述第二内腔具有纵向延伸通过所述导管本体的内部通道和小于所述第一内腔长度的长度；以及
被附接到所述第二内腔的内腔末端段，并且所述内腔末端段具有纵向延伸通过所述内腔末端段的通道，以致所述内腔末端段的所述通道与所述第二内腔的所述通道连通。
27.如权利要求26所述的设备，其中所述内腔末端段由不同于所述第二内腔材料的材料构成。
28.如权利要求27所述的设备，其中所述内腔末端段由不同于所述第二内腔的硬度的材料形成。
29.如权利要求26所述的设备，其中所述第一内腔和所述内腔末端段是分开的，但基本上相互平行。
30.如权利要求26所述的设备，其中所述第一内腔和所述内腔末端段是分开的并且在所述导管本体的远侧端以一角度相互分叉。
31.如权利要求26所述的设备，其中所述第一内腔和所述内腔末端段中的至少一个是曲线的。
32.如权利要求26所述的设备，其中所述第一内腔和所述内腔末端段中的至少一个具有D形结构。
33.如权利要求26所述的设备，其中所述导管本体的所述第一内腔和第二内腔在所述导管本体内具有双D形结构。
34.如权利要求26所述的设备，其中所述第一内腔和第二内腔具有不同的截面面积。
35.如权利要求26所述的设备，其中所述第一内腔和所述内腔末端段具有不同的形状。
36.如权利要求26所述的设备，还包括被附接到所述第一或第二内腔的近侧端的第二内腔末端段，所述第二内腔末端段具有纵向延伸通过所述第二内腔末端段的通道，以致所述第二内腔末端段的所述通道与所述第二内腔末端段所附接到的所述内腔的所述通道连通。
37.一种分裂末端导管设备，所述设备包括：
导管本体；
与所述导管本体为一体的第一远侧末端段，所述第一远侧段具有纵向延伸通过所述导管本体的第一内腔的内部通道；以及
接合到所述导管本体的第二远侧末端段，所述第二远侧末端段提供自所述导管本体的第二内腔的流体通道并且所述流体通道纵向延伸通过所述第二末端段。
38.如权利要求37所述的设备，其中一个远侧末端段由不同于另一个远侧末端段材料的材料构成。
39.如权利要求38所述的设备，其中一个远侧末端段由比另一个远侧末端段更柔韧的材料构成。
40.如权利要求37所述的设备，其中所述第一和第二末端段是分开的，但基本上相互平行。
41.如权利要求37所述的设备，其中所述第一和第二末端段是分开的并且在所述导管本体的远侧端以一角度相互分叉。
42.如权利要求37所述的设备，其中所述第一和第二末端段中的至少一个是曲线的或呈现复合角。
43.如权利要求37所述的设备，其中所述第一和第二末端段中的至少一个具有D形结构。
44.如权利要求37所述的设备，其中所述第一和第二内腔具有不同的截面面积或形状。
45.如权利要求37所述的设备，还包括在所述末端段中的至少一个的一侧的至少一个流体通孔。
46.如权利要求37所述的设备，还包括将所述第一和第二末端段固定在一起的生物可吸收粘合剂。
47.如权利要求37所述的设备，还包括在所述第一和第二末端段的至少部分上的涂覆层。
48.如权利要求37所述的设备，其中所述涂覆层包括至少一种选自由抗血栓试剂、抗菌试剂和消炎试剂组成的组的试剂。
49.如权利要求37所述的设备，还包括第二分裂端部分，所述第二分裂端部分包括与所述导管本体为一体的第一近侧末端段，以及与所述第一近侧段分开并且接合到所述导管本体的第二近侧末端段，所述第二近侧末端段提供自所述导管本体的内腔的流体通道并且所述流体通道纵向延伸通过所述第二末端段。
50.如权利要求37所述的设备，其中所述设备还包括选自由血液透析导管和中心静脉导管组成的组的导管。
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