CN108290024A - 递送导管系统和装置 - Google Patents

递送导管系统和装置 Download PDF

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CN108290024A
CN108290024A CN201680052526.1A CN201680052526A CN108290024A CN 108290024 A CN108290024 A CN 108290024A CN 201680052526 A CN201680052526 A CN 201680052526A CN 108290024 A CN108290024 A CN 108290024A
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elongate body
pipe shaft
auxiliary tube
distal end
main tube
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CN108290024B (zh
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赖恩·T·克罗内
弗朗西斯科·巴伦西亚
马尼什·加达
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Evalve Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • 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
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0147—Tip steering devices with movable mechanical means, e.g. pull wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
    • 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
    • A61M2025/0036—Multi-lumen catheters with stationary elements with more than four lumina
    • 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
    • A61M2025/004—Multi-lumen catheters with stationary elements characterized by lumina being arranged circumferentially
    • 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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • 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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids

Abstract

一种血管内装置(104)，该血管内装置包括具有本体(234)的管身，该本体(234)限定有主管腔(226)和多个辅助管腔(228)。辅助管腔在主管腔周围间隔开。主管腔和多个辅助管腔从本体的近端(108)延伸到本体的远端(110)。一根或多根线可以延伸穿过主管腔和/或辅助管腔。

Description

递送导管系统和装置
相关申请的交叉引用
本申请要求于2015年8月6日提交的美国申请No.14/820,141的权益和优先权；其全部内容通过引用并入本文。
背景技术
通过使导管系统穿过一个或多个体腔到目标位置，可以从远程位置触及目标位置。当使用患者的血管系统时，将导管系统经由皮肤或经由患者身体中的小切口插入到动脉或静脉中，以允许导管系统穿过患者身体到达目标位置。当经由皮肤插入导管系统时，可以使用导引鞘。导引鞘创建通道或管路以将各种医疗装置插入患者的脉管系统并到达目标位置。例如，医疗装置可以包括手术器械、光纤电缆、激光器、电子装置或能够监测患者体内的一项或多项生理状况或参数的传感器。诸如在体腔内的目标位置处或在目标位置附近的结构或者所递送的医疗装置的特定需求使得这种医疗装置的精确递送仍然是一个挑战。
由于一些医疗装置待被递送到体腔，进入体腔中的装置将以近似于该装置进入体腔所呈角度的角度伸入到体腔中。如果目标位置与体腔的入口点不在一条近似的直线上，那么可能需要朝向体腔内的目标位置引导导管系统。此外，某些过程可能需要医疗设备的超出特定位置的特定对准。在使医疗装置前进穿过导管或其他递送系统之后，可以将医疗装置转向到体腔内的位置，但是对于涉及使用多个医疗装置的过程，其可以进一步减少用于使导管或其他递送系统转向和对准以提供后续装置的一致递送的步骤的时间和成本。
例如，为了实现进入心脏的左心房，可以使导管和/或进入鞘从股静脉中的穿孔穿过下腔静脉进入右心房并通过心房间隔中的穿孔进入左心房。该路径然后可以用于触及位于左心房与左心室之间的二尖瓣。由于二尖瓣位于进入左心房的入口点的下方，插入的装置需要在进入之后被向下(即朝向左心室)并朝向二尖瓣引导。此外，用于将介入治疗应用于二尖瓣的装置可能需要与瓣膜接合部、小叶或接合线精确对准以执行预期的步骤。
例如，所述装置还可以被引导穿过瓣膜腱索或乳头肌，以用于对二尖瓣进行介入治疗。当这些步骤要求使用多于一个器械时，每个器械将依赖于相对于瓣膜的适当定位。因此，每个器械都需要内置定位或转向机构。这增加了这些步骤的成本、复杂性和时间。
其他步骤可以包括使导管和/或进入鞘从股静脉中的穿孔通过心房间隔膜到达左心房。该路径可用于进入左心房以用于切除心房壁或在肺静脉周围的切除。这种介入疗法将需要与目标区域精确对准以用于适当的切除位置。另外，可能需要替代的进入路线和/或到达其他体腔的进入路线。
为了克服这些挑战中的一部分，可转向导管系统包括一根或多根线，其允许操作者在导管系统的近端处的手动弯曲导管系统。由此，导管系统可以包括具有操作者可调节的曲率的远端部分或的其他部分，以允许导管系统向目标位置的行进。然而，导管系统中的一根或多根线可能会在导管系统内移位。此外，在脉管系统的行进期间扭转导管系统可能导致这种导管系统中的内容物的位置改变。线在引导导管或递送导管内的移动可能会不利地影响导管在患者体内可能的定向精度或者不利地影响附接至其远端的医疗装置的操作和/或布置的可能的控制精度。
发明内容
提供本概述是为了介绍将在以下详细描述中进一步描述的理念的选择。本概述无意于指明所要求保护的主题的特定特征，也不旨在用于帮助限制所要求保护的主题的范围。
在一个实施方式中，血管内装置包括限定有主管腔和多个辅助管腔的长形本体。长形本体具有近端和远端以及在近端与远端之间的长度。主管腔和多个辅助管腔延伸穿过长形本体的长度的至少一部分。血管内装置还包括连接至长形本体的加强层，该加强层包括具有比长形本体的本体材料的弹性模量大的弹性模量的加强材料。
在另一个实施方式中，血管内装置包括限定有主管腔和多个辅助管腔的长形本体，其中，医疗装置连接至该长形本体的远端。主管腔和多个辅助管腔从长形本体的近端延伸至长形本体的远端。
在又一个实施方式中，递送导管系统包括管身、手柄和控制线。该管身包括限定有主管腔和多个辅助管腔的长形本体。长形本体具有近端和远端以及在近端与远端之间的长度。手柄可操作地连接至长形本体的近端，并且控制线可操作地连接至手柄。控制线从长形本体的近端穿过多个辅助管腔中的至少一者延伸至长形本体的远端。
本公开的实施方式的附加特征将在下面的描述中阐述。这些实施方式的特征可以借助于在所附权利要求中特别指出的器械和组合来实现。这些和其他特征将通过以下描述和所附权利要求而变得更加明显，或者可以通过如下文所阐述的这些示例性实施方式的实践来了解这些和其他特征。
附图说明
为了描述可以获得本公开的上述和其他特征的方式，将通过参照在附图中示出的本发明的具体实施方式来呈现更具体的描述。为了更好地理解，贯穿各个附图，相似的元件已经由相同的附图标记指定。尽管一些附图可以是概念的示意性或夸大的表示，但至少一些附图可以是按比例绘制的。需要理解，附图描绘了一些示例性实施方式，将通过使用附图用额外的特征和细节来描述和解释这些实施方式，在附图中：
图1是根据本文描述的至少一个实施方式的递送导管系统的示意图；
图2是根据本文描述的至少一个实施方式的可转向至左二尖瓣的递送导管的剖视图；
图3是根据本文描述的至少一个实施方式的递送导管的横截面图；
图4是根据本文描述的至少一个实施方式的另一递送导管的横截面图；
图5是根据本文描述的至少一个实施方式的具有外衬套的递送导管的横截面图；
图6是根据本文描述的至少一个实施方式的具有辅助管腔衬套的递送导管的横截面图；
图7是根据本文描述的至少一个实施方式的具有分层鞘的递送导管的透视剖面图；
图8是根据本文描述的至少一个实施方式的在管身中具有分层鞘的递送导管的横截面图；
图9是根据本文描述的至少一个实施方式的具有多于四个辅助管腔的递送导管的横截面图；
图10是根据本文描述的至少一个实施方式的递送导管的纵向截面图；
图11是根据本文描述的至少一个实施方式的导管的远端的纵向截面图；
图12是根据本文描述的至少一个实施方式的沿第一方向偏转的图11的导管的远端的纵向截面图；
图13是根据本文描述的至少一个实施方式的沿第二方向偏转的图11的导管的远端的纵向截面图；
图14是根据本文描述的至少一个实施方式的在其上具有无创帽的图11的导管的远端的纵向截面图；
具体实施方式
下面将描述本公开的一个或多个特定实施方式。为了提供这些实施方式的简要描述，可以在说明书中描述实际实施方式的一些特征。应该认识到，在任何这样的实际实施方式的研发中，如在任何策划或设计方案中，将做出许多实施方式特有的决定以实现开发者的特定目标，诸如符合系统相关和商业相关的约束，这些特定目标可能从一个实施方式到另一个实施方式发生改变。应该进一步认识到，这种研发工作可能是复杂且耗时的，但是尽管如此，这种研发工作对于受益于本公开的普通技术人员而言仍然是设计、制作和制造的常规任务。
本公开的一个或多个实施方式总体上涉及制造和使用递送导管系统或可转向导管。递送导管系统可以允许医疗专业人员将血管内装置或其他医疗装置递送到患者体内的目标位置。尽管本公开将描述与心脏中的血管手术相关的递送导管系统及其应用，但应当理解，本文所述的装置、系统和方法可以适用于其他身体管腔和/或体腔。此外，与本文描绘和/或描述的任何实施方式相关地描述的元件可以和与本文描绘和/或描述的任何其他实施方式相关地描述的元件组合。例如，与图3中描绘的实施方式相关地描述的任何元件可以与图9中描述的实施方式组合。
递送导管系统可以具有管身，该管身包括大致环形的本体，该本体限定了延伸穿过其中的中央主管腔。环形本体可以包括围绕主管腔定位并提供与主管腔隔离的导管的多个辅助管腔。主管腔可以包括位于其中的压缩线圈以促进导管管身的可推动性。例如，压缩线圈可以抵抗压缩并且允许管身的横向柔性。主管腔可以定尺寸成接收一个或多个医疗装置，包括导丝、扩张导管、可植入装置、圈套器、其他医疗装置或其组合。
辅助管腔可以由管身的本体限定。例如，辅助管腔可以与管身的本体一体形成。在另一个示例中，辅助管腔可以通过一种或多种材料多管腔挤压而形成，以使辅助管腔与管身同时形成。因此，辅助管腔可以具有相对于彼此以及相对于主管腔的限定的位置，其中，主管腔相对于本体固定。辅助管腔可以构造成容纳并引导一根或多根控制线从管身的近端穿过辅助管腔到达管身的远端。在一些实施方式中，至少一根线可以连接至管身的远端，以允许使用者通过在管身的近端处和/或在管身的近端附近推动和/或拉动控制线来使管身的远端偏转。
图1示出了具有手柄102、导管104以及可选的医疗装置106的递送导管系统100的示意图。手柄102可以连接至导管104的近端108并且可以构造成与导管104的一个或多个管腔连通。医疗装置106可连接至导管104的远端110。导管的一个或多个管腔可以允许手柄102与医疗装置106连通。在至少一个实施方式中，医疗装置106可以是替代心脏瓣膜，例如构造成与患者心脏的二尖瓣接合的二尖瓣夹。二尖瓣夹可以具有一个或多个可移动元件。在一些实施方式中，导管104的至少一个管腔可以允许手柄102使导管的远端110偏转。在其他实施方式中，导管104的至少一个管腔可以允许手柄102使二尖瓣夹的一个或多个可移动元件移动。
虽然本申请可以描述与二尖瓣相关的递送导管系统100的使用以及相关的修复和/或替换，但应当理解，递送导管系统100可以用于其他位置和/或步骤。例如，递送导管系统100可以用于将医疗装置递送到三尖瓣以用于修复和/或替换。心脏的二尖瓣是允许血液从左心房流向左心室的瓣膜(并且类似地，限制或阻止相反方向的流动)，而三尖瓣位于右心房和右心室之间并且控制血液在其间的流动。在一些实施方式中，递送导管系统100可以构造成通过患者的脉管系统将用于修复三尖瓣的替换瓣膜或其他医疗装置递送到右心房。在其他应用中，递送导管系统100可以用于通过脉管系统或其他体腔将医疗装置递送到患者身体的其他位置。
例如，图2是患者的心脏112和使用根据本公开的递送导管系统进行的医疗步骤的示意图。可以将导管104(在图2中示出，未附接有医疗装置)插入患者的脉管系统并且将导管104引导到下腔静脉114。可以通过纵向地向导管104施加力推动导管104穿过下腔静脉114朝向心脏112移动。在从下腔静脉114进入心脏112时，导管104进入右心房116。导管104必须到达左心房118以触及心脏112的二尖瓣120。导管104可以通过心脏间隔膜中的穿孔122到达左心房118。为此，可以通过定位在导管104内部的一根或多根控制线使导管104的远端110偏转。控制线在导管104内的精确定位可以允许对导管104的远端110的偏转进行精确控制。导管104的远端110的精确控制可以允许心脏间隔膜中的较小穿孔，更可靠且更快速的二尖瓣夹在二尖瓣上的定位以及操作过程中的其他改进或其组合。虽然本公开可以提供与将二尖瓣夹递送到患者的心脏112相关的医疗装置106以及操作过程的示例，但是应当理解，本领域的技术人员可以构想出根据本公开的导管系统100的其他应用。
图3是根据本公开的导管204的实施方式的横截面。导管204的管身224可以包括主管腔226和一个或多个辅助管腔228。在一些实施方式中，管身224可以具有圆形的横截面(例如，管身224可以是大致圆筒形的)。在其他实施方式中，管身224可以具有非圆形的横截面，例如，管身224可以具有正方形、三角形、五角形、八角形、其他多边形、椭圆形、规则的、不规则的或其组合的横截面。主管腔226可以在管身224内居中定位，使得主管腔226和管身224共用共同的纵向轴线230。纵向轴线230正交于图3中描绘的横截面。在其他实施方式中，主管腔226可以在管身224内定位成与管身224的纵向轴线230不同轴。例如，主管腔226可以在管身224内偏置。在另一示例中，管身224可以具有多个主管腔226。多个主管腔226可以围绕管身224的纵向轴线230分布和/或布置。
在一些实施方式中，主管腔226的横截面可以是圆形的，而在其他实施方式中，主管腔226可以具有其他的截面形状。在其他实施方式中，主管腔226可以具有正方形、三角形、五角形、八角形、其他多边形、椭圆形、规则的、不规则的或其组合的横截面。在具有多个主管腔226的实施方式中，主管腔226可以具有相同的尺寸或具有不同的尺寸。在具有多个主管腔226的实施方式中，主管腔226可以具有相同形状或不同形状的横截面。例如，在内部具有两个主管腔226的管身224中，每个主管腔226可以具有彼此互补成近似圆形的半圆形横截面。在另一示例中，第一主管腔可以具有圆形横截面，并且第二主管腔可以具有互补地接合并且部分包围第一主管腔的新月形横截面。
管身224可以具有多个辅助管腔228。在一些实施方式中，辅助管腔228可以围绕纵向轴线230均匀地分布。例如，辅助管腔228可以基于辅助管腔228的数量等间隔地围绕纵向轴线230分布。四个辅助管腔228可以以90°的相等间隔分布。三个辅助管腔228可以以120°的相等间隔分布。在其他实施方式中，辅助管腔228中的至少两者可以相对于管身224的纵向轴线230大致彼此相对。两个辅助管腔228可以在两个辅助管腔228中的各者的辅助管腔轴线232关于穿过管身224的纵向轴线230获得的镜面对称的情况下大致彼此相对。在又一些实施方式中，两个辅助管腔228可以在两个辅助管腔228关于穿过管身224的纵向轴线230获得的镜面对称的情况下大致彼此相对(例如，两个辅助管腔228关于管身224的纵向轴线230呈现为反转对称)。
主管腔226和辅助管腔228可以与管身224的本体234一体地形成。本体234可以由例如热塑性弹性体(TPE)的多种柔性本体材料制成或者包括例如热塑性弹性体(TPE)的多种柔性本体材料。在一些实施方式中，本体234可以是聚醚嵌段酰胺(PEBA)。本体234可以具有恒定的硬度或者可以具有沿着本体234的纵向长度变化的硬度。例如，本体234可以由硬度为35D至55D的本体材料制成或者包括硬度为35D至55D的本体材料。在另一示例中，本体234可以由硬度大约为45D的本体材料制成或者包括硬度大约为45D的本体材料。在至少一个实施方式中，本体材料可以包括PEBAX4533。在至少另一实施方式中，本体材料可以包括PEBAX3533。
本体234可以是通过多管腔挤压工艺制造的一体式挤压本体。例如，主管腔226和辅助管腔228可以在本体材料的挤压过程中同时形成以形成管身224的本体234。在其他实施方式中，本体234可以具有多于一种的本体材料和/或本体材料层。本体234可以被共同挤压，并且一个或多个层可以被顺序地或平行地挤压以形成管身224的本体234。例如，本体234的内部部分可以被挤压，其中，该内部部分限定出主管腔226。本体234的外部部分可以在内部部分的上面同时或稍后挤压，其中，该外部部分限定出辅助管腔228。
管身224的本体234可以将主管腔和辅助管腔大致相对于彼此限定成使得主管腔226和辅助管腔228相对于管身224的纵向轴线230固定就位，并且具有相对于本体234的尺寸而言固定的尺寸。管身224的本体234可以具有本体半径235，本体半径235在具有上限值和下限值并且包括0.040英寸、0.045英寸、0.050英寸、0.055英寸、0.060英寸、0.065英寸、0.070英寸、0.075英寸、0.080英寸中的任何值或其间的任何值的范围内。本体半径235可以通过从管身224的纵向轴线230至本体234的外表面测量得出。在具有非圆形本体(例如八角形本体)的实施方式中，本体半径235可以近似为从非圆形本体的纵向轴线到本体的外表面的平均距离。在至少一个实施方式中，本体234可以具有在0.050英寸至0.070英寸的范围内的本体半径235。例如，身体半径235可以是大约0.060英寸。
在一些实施方式中，主管腔半径236可以处于相对于本体半径235具有一定比值的范围内。主管腔比可以是主管腔半径236与本体半径235的比值。主管腔比可以在具有上限值和下限值并且包括0.400、0.425、0.450、0.475、0.500、0.525中的任何值或其间的任何值的范围内。例如，主管腔比可以在0.400到0.525的范围内。在另一个示例中，主管腔比可以在0.450到0.500的范围内。在又一个示例中，主管腔比可以是0.475。
辅助管腔228可以具有从辅助管腔轴线232起测量得到的辅助管腔半径238。辅助管腔比可以限定相对于本体半径235辅助管腔半径238。辅助管腔比可以在具有上限值和下限值并且包括0.100、0.125、0.150、0.175、0.200中的任何值或其间的任何值的范围内。例如，主管腔比可以在0.100到0.200的范围内。在另一示例中，主管腔比可以在0.125到0.175的范围内。在又一示例中，主管腔比可以是0.150。
如本文所述，本体234可以限定主管腔226和辅助管腔228以及它们相对于彼此的位置。主管腔226和辅助管腔228可以由本体234的限定管腔壁240的部分分隔开。管腔壁240可以坚固到足以防止主管腔226或辅助管腔228的穿孔和/或破裂而连通到另一者。例如，管腔壁240可以具有相对于本体半径235的厚度。在一些实施方式中，管腔壁240的厚度相对于本体半径235的壁比可以在具有上限值和下限值并且包括0.100、0.110、0.120、0.130、0.140、0.150、大于0.150的值中的任何值或其间的任何值的范围内。例如，壁比可以在0.100到0.150的范围内。在另一个示例中，壁比可以在0.110到0.140的范围内。在又一示例中，壁比可以是0.120。
辅助管腔228可以具有远离管身224的纵向轴线230某一距离定位的辅助管腔轴线232。在一些实施方式中，辅助轴线半径242可以至少部分地取决于本体半径235并可以由辅助轴线比限定。辅助轴线比可以在具有上限值和下限值并且包括0.650、0.675、0.700、0.725、0.750、0.775、0.800、0.825、0.850中的任何值或其间的任何值的范围内。例如，辅助轴线比可以在0.650到0.850的范围内。在另一个示例中，辅助轴线比可以在0.700到0.800的范围内。在又一示例中，辅助轴线比可以是0.750。
在一些实施方式中，管身224可以被加强(即，为了在使用期间增加可推动性)。图4描绘了管身324的另一个实施方式，该管身324具有位于本体334的主管腔326内的压缩线圈344。压缩线圈344可以是由弹性线圈材料制成或包括弹性线圈材料的螺旋线圈。例如，线圈材料可以是不锈钢、镍钛(例如镍钛诺)、其他金属合金、热塑性塑料、其他聚合物或其组合。在至少一个实施方式中，压缩线圈344可以是具有11：1或更高的下垂值的不锈钢线圈。压缩线圈344可以相对于主管腔326定尺寸成使得压缩线圈344具有与主管腔326的内径(“ID”)基本相同的外径(“OD”)。在其他实施方式中，压缩线圈344可以相对于主管腔326定尺寸成使得压缩线圈344具有小于主管腔326的ID的OD。在又一些实施方式中，压缩线圈344可以相对于主管腔326定尺寸成使得压缩线圈344具有小于主管腔326的ID的OD。
当压缩线圈344具有大于主管腔326的ID的OD时，压缩线圈344可以将力径向向外地施加到本体334上。当压缩线圈344具有小于主管腔326的ID的OD时，本体334可以在横向柔性方面较少地受到压缩线圈344的限制。在一些实施方式中，压缩线圈344可以具有如下线圈比(即，在主管腔中没有压缩线圈344的情况下，从纵向轴线320起测量的线圈半径346与松弛的主管腔半径336的比值)，该线圈比处于具有上限值和下限值并且包括0.80、0.85、0.90、0.95、1.00、1.05、1.10、1.15、1.20中的任何值或其间的任何值的范围内。例如，线圈比可以在0.80到1.20的范围内。在另一个示例中，线圈比可以在0.80到0.100的范围内。在又一示例中，线圈比可以在1.00到0.120的范围内。
压缩线圈344可以在根据本公开的递送导管系统行进通过患者的脉管系统的管腔或其他系统期间提供额外的可推动性。定尺寸成向管身324的本体334施加径向力的压缩线圈344可以限制或基本上防止压缩线圈344相对于本体334的运动，从而与没有压缩线圈344的管身324相比更加有效地将施加到导管的近端的力传递到导管的远端。例如，压缩线圈344可以更有效地将施加到导管的近端的纵向力传递到导管的远端。在另一示例中，压缩线圈344可以更有效地将施加到导管的近端的扭矩传递到导管的远端。
在一些实施方式中，管身的至少一部分可以具有外护套。图5描绘了具有固定至其上的外护套448的管身424的实施方式。外护套448可以由单一材料制成或包括单一材料，或者可以由不同材料制成或包括不同材料以将不同的操作特性赋予管身424。例如，外护套448可以由较软的材料制成或包括较软的材料以提高管身424的柔性。在其他示例中，外护套448可以由更硬的材料制成或包括更硬的材料以提高管身424的可推动性和/或可扭转性。在其他示例中，外护套448可以由润滑材料制成或包括润滑材料以减少管身424与患者的体腔之间的摩擦。外护套448可以包括PEBA、聚四氟乙烯(“PTFE”)、聚醚醚酮(“PEEK”)、其他聚合物、不锈钢、镍钛诺、其他金属或其组合。在至少一个实施方式中，外护套448可以包括具有不同硬度的多种PEBA材料。
在一些实施方式中，外护套448可以包括不透射线的标记以改善医疗过程期间管身424的可视性。例如，外护套448可以包括位于外护套448的远端部分中的硫酸钡(BaSO4)、金、碘、其他不透射线的材料或其组合。在至少一个实施方式中，不透射线的标记可以纵向地位于管身424的远端部分和/或中间部分。
图6是具有位于主管腔526和辅助管腔528上的衬套的管身524的横截面图。主管腔526可以具有沿其表面的主管腔衬套552，以为管身524的本体534提供额外的保护。主管腔衬套可以是PTFE、PEEK、其他润滑聚合物涂层或其组合。在一些实施方式中，主管腔衬套552可以沿着压缩线圈544的内表面，如图6所示；而在其他实施方式中，主管腔衬套552可以与本体534直接接触。主管腔衬套552可以提供主管腔526的从管身524的近端到管身524的远端的大致连续的表面。在其他实施方式中，主管腔衬套552可以在小于管身524的整个长度的部分中纵向地定位在管身524内。例如，主管腔衬套552可以位于管身524的远端部分中、位于管身524的中间部分中、位于管身524的近端部分中或其组合。主管腔衬套552可以在主管腔526内连续地分布，或者主管腔衬套552可以在主管腔526内不连续地(即，以多个区段)分布。
类似地，辅助管腔528可具有沿其表面的辅助管腔衬套554，以为管身524的本体534提供额外的保护。辅助管腔衬套554可以是PTFE、PEEK、其他润滑聚合物涂层或其组合。在一些实施方式中，辅助管腔衬套554可以提供辅助管腔528的从管身524的近端到管身524的远端的大致连续的表面。在其他实施方式中，辅助管腔衬套554可以在管身524内纵向地定位于小于管身524的整个长度的部分中。例如，辅助管腔衬套554可以位于管身524的远端部分、位于管身524的中间部分中、位于管身524的近端部分中或其组合。辅助管腔衬套554可以在辅助管腔528内连续地分布，或者辅助管腔衬套554可以在主管腔526内不连续地(即，在多个区段中)分布。辅助管腔衬套554可以在多个辅助管腔528中基本相同和/或对称地分布(例如，每个辅助管腔528可以覆盖相同的纵向部分)，或者辅助管腔衬套554可以在多个辅助管腔528中以不同方式分布。例如，管身524可以具有四个辅助管腔528，如图6所示，其中，两个成对的辅助管腔528基本上彼此相对且位于主管腔526的两侧。在一些实施方式中，基本上彼此相对的每对辅助管腔528可以具有分布基本上相同的辅助管腔衬套554。
加强层可以为管身提供额外的结构支承和/或额外的力传递能力。例如，图7描绘了层叠在管身624的本体634之上的加强层656的实施方式的剖视图。加强层656可以围绕本体634周向延伸并且可以包括一个或多个材料层。在所描绘的实施方式中，加强层656包括两个材料层658，该材料层658包含围绕本体634螺旋延伸的丝线660。在其他实施方式中，加强层656可以包含垂直于管身624的纵向轴线围绕本体634延伸的丝线660。在其他实施方式中，加强层656可以包含平行于管身624的纵向轴线围绕本体634延伸的丝线660。
在一些实施方式中，加强层656可以包括编织在一起的一根或多根丝线660以提供一个或多个层658。例如，层658可以包括彼此呈一定角度地延伸并以重复图案编织在一起的多根丝线660。多根丝线660可以以下述形式编织：双线两下两上的菱形形式(a diamondtwo wire two-under-two,over-two pattern)；半负载单线一上一下的形式(a half-loadsingle wire over-one)；全负载单线两上两下的形式(a full-load single wire over-two,under-two pattern)；其他替代的编织形式；或其组合。在其他实施方式中，加强层656可以包括沿着大致笔直的路线纵向穿过多根丝线660的单根丝线660。
丝线660可以是圆形丝线、椭圆形丝线或扁平丝线。丝线660可以由多种加强材料制成或包括各种加强材料，诸如金属、金属合金、热塑性塑料、其他聚合物或其组合。在一些实施方式中，加强材料可以具有大于本体材料的弹性模量。例如，加强层656可以包括具有不同性质的丝线660的混合物，诸如编织有聚合物丝线的不锈钢丝线。在至少一个实施方式中，加强层656可以包括以菱形形式编织的多根304不锈钢丝线。加强层656的这种实施方式可以包括16至32根不锈钢丝线660。
在各种实施方式中，加强层656可以加强管身624的不同部分。例如，加强层656可以围绕本体634周向延伸以加强管身624的在管身624的近端部分、管身624的中间部分、管身624的远端部分或其组合中的纵向部段。由此，加强层656可以在不同位置处提供管身624的扭转、横向或纵向的加强，以改善递送导管系统的穿过患者的脉管系统或其他体腔的行进。
图8是管身724的另一个实施方式的横截面图。管身724可以包括外护套748，外护套748可以类似于关于图5描述的外护套448，并定位成在加强层756外部并环绕加强层756，加强层756可以类似于关于图7描述的加强层656。外护套748可以包封和/或覆盖加强层756。外护套748可以被沉积、挤压、模制、热收缩或以其他方式施加于管身724并位于加强层756上，从而结合到加强层756。在一些实施方式中，外护套748的材料的至少一部分可以渗入加强层756的编织物。外护套748的材料的至少一部分渗入加强层756可以限制或基本上防止外护套748从加强层756和/或本体734的脱落。
现在参照图9，管身824可以具有定位成基本上彼此相对的多个辅助管腔828A、828B、828C。在所描绘的实施方式中，管身824具有围绕主管腔826径向分布的三对辅助管腔828。每对辅助管腔828A、828B、828C可以包含一对控制线858A、858B、858C。控制线858A、858B、858C可以从管身824的近端延伸到远端。控制线858A，858B，858C可以允许(诸如关于图1所描述的)手柄将力施加到管身824的远端或施加到连接至管身824的远端的医疗装置。在一些实施方式中，每对辅助管腔828A、828B、828C可以包括一对控制线858A，858B，858C。在其他实施方式中，至少一对辅助管腔828A、828B、828C可以不包括一对控制线858A、858B、858C。在其他实施方式中，一对辅助管腔中只有一个辅助管腔可以包括控制线。
图10是具有近端部分960、中间部分962和远端部分964的管身924的纵向横截面。管身924从近端908延伸到远端910。管身924的本体934可以从近端908延伸到远端910并且可以具有在本体934的至少一部分上延伸的外护套948。例如，图10中所描绘的外护套948在本体934的近端部分960上延伸，并且中间部分962和远端部分964可以缺少外护套。在其他实施方式中，外护套948可以在中间部分962和/或远端部分964上延伸。在其他实施方式中，外护套948可以仅在近端部分960的部段、中间部分962的部段、远端部分964的部段或其组合上延伸。
辅助管腔928可以提供穿过管身924的导管，以用于可以连接至医疗装置的控制线，其中，该医疗装置连接至导管的远端910。控制线可以允许位于导管近端的手柄控制医疗装置诸如二尖瓣夹的操作和/或布置。例如，控制线可以连接至二尖瓣夹以允许对二尖瓣夹的打开和/或关闭进行控制。可以通过控制线的相对较小的移动来控制二尖瓣夹的打开和关闭的程度。因此，可预测且稳定的辅助管腔可以提高二尖瓣夹的放置精度。
管身924可以具有适合进入患者身体的期望部分的任何长度。在一些实施方式中，管身924的长度可以是60英寸。在其他实施方式中，管身924的长度可以长于或短于60英寸。近端部分960可以形成管身924的大部分，并且在一些实施方式中，近端部分960的长度与管身924的长度所得出的近端部分比可以在具有上限值和下限值并且包括0.70、0.72、0.74、0.76、0.78、0.80、0.82、0.84、0.86、0.88、0.90、0.92、0.94中的任何值或其间的任何值的范围内。例如，近端部分比可以在0.70到0.94的范围内。在另一示例中，近端部分比可以在0.80到0.90的范围内。在又一示例中，近端部分比可以是0.86。远端部分964的长度与管身924的长度所得出的远端部分比可以在具有上限值和下限值并且包括0.04、0.06、0.08、0.10、0.12、0.14、0.16、0.18、0.20中的任何值或其间的任何值的范围内。例如，远端部分比可以在0.04到0.20的范围内。在另一示例中，远端部分比可以在0.08到0.16的范围内。在又一示例中，远端部分比可以是0.10。中间部分962可以占据管身924的长度中的剩余部分。在一些实施方式中，管身924可以不包括中间部分962。中间部分962的长度与管身924的长度所得出的中间部分比可以在具有上限值和下限值并且包括0.00、0.02、0.04、0.06、0.08、0.10、0.12、0.14、0.16、0.18、0.20中的任何值或其间的任何值的范围内。例如，远端部分比可以在0.00到0.20的范围内。在另一示例中，远端部分比可以在0.02到0.10的范围内。在又一示例中，远端部分比可以是0.04。
在至少一个实施方式中，管身924包括远端部分964中的PEBAX 3533以及中间部分962和近端部分960中的PEBAX 4533。本体934可以具有沿着管身924的长度的基本恒定的外径。因此，本体934可以沿其长度具有不同的操作特性，同时保持恒定的外径。在其他实施方式中，远端部分964和/或中间部分962可以包括朝向远端910的渐缩部。在渐缩的远端部分964的给定纵向位置处可以减少本体934和/或管身924中的整体材料，从而提高本体934的柔性和/或调节管身924的弯曲轮廓。
图11至图13描绘了导管的实施方式，例如在可转向导管应用中，该导管可以使用控制线来控制管身924的位置和/或偏转。图11描绘了图10中的管身924的远端部分964，其中，一对控制线958位于辅助管腔928中。控制线958可以在远端910处或在远端910附近连接至管身924并且穿过辅助管腔向近端延伸。在其他实施方式中，控制线958可以不在远端910处连接至本体934的远端部分964。如本文所述，控制线958可以将施加在控制线958的近端(未示出)的力传递到控制线958的远端966。然后，控制线958的远端966可以将力传递到管身924的远端部分964。
图12描绘了施加到连接至管身924的远端910的第一控制线958的近端力968。近端力968可以使第一控制线958向近端移动。然后，第一控制线958的移动可以向远端910施加扭矩并且使远端910在第一控制线958的横向方向上相对于主管腔926旋转和/或偏转。然后，管身924的远端部分964包括主管腔926可以横向移动，从而提供穿过主管腔926的弓形递送路径。可以使用控制线958的移动来定位主管腔926，以在患者体内的体腔中精确地递送医疗装置(例如关于图1描述的医疗装置106)或其他装置或物体。
如图13所描绘的，可以通过在管身924的180°旋转之后将近端力968施加在第二控制线958上或施加在相同的第一控制线958上来使管身924的远端部分964沿另一方向偏转。如本文所述，管身924可以是旋转对称的，使得一对控制线958可以在相反的方向上产生相等的偏转。
虽然在本文中，导管管身已经被描述为递送连接至管身的远端的医疗装置，但是根据本公开的导管可以构造成在未连接有装置的情况下穿过患者身体的体腔，并且可以提供管路来将其他装置或设备引导到患者体内的期望位置。例如，图14示出了具有位于远端1010处的无创末端1074的管身1024的侧截面图。管身1024的主管腔1026可以延伸穿过远端1010处的无创末端以提供来自管身1024的近端(未示出)的导管。
包括具有由本体限定并且相对于彼此固定就位的多个管腔的管身的导管系统可以允许导管系统在患者体内更精确的转向和放置。医疗专业人员可以将导管系统的远端部分引导到体腔中的期望位置，而不必担心导管系统内的管腔或其他元件相对于彼此移位。此外，在至少一些实施方式中，限定多个管腔的单体本体可以更有效地将力从管身的近端传递到管身的远端，并且具有较低的使管身扭结或折叠的倾向。
冠词“一”、“一个”和“该”旨在表示在前面的描述中有一个或多个元件。术语“包括”、“包含”和“具有”意在是包含性的并且意味着除了列出的元件之外可以存在其他元件。另外，应该认识到，对本公开的“一个实施方式”或“实施方式”的引用无意于被解读为排除也包括所述特征的其他实施方式的存在。本文所述的数字，百分比、比值或其他值旨在包括该值，也包括“大约”或“近似”所述值的其他值，正如由本发明的实施方式所涵盖的领域中的普通技术人员所理解的那样。因此，所述值应该宽泛地解读成足以涵盖至少足够接近所述值并且足以执行期望功能或获得期望结果的值。所述值至少包括在合适的制造或生产过程中可预期的变化，并且所述变化可以包括在所述值的5％以内、1％以内、0.1％以内或0.01％以内的值。
本领域的普通技术人员应该认识到对于本公开内容，等同的构造不脱离本公开的精神和范围，并且在不脱离本公开的精神和范围的情况下可以对公开的实施方式进行各种改变、替换和变化。包括功能性的“方式加功能”条款的等同的构造旨在涵盖在此描述的执行所述功能的结构，包括以相同方式操作的结构等同特征和提供相同功能的等同结构。申请人要表达的意图是除了其中“用于......的装置”一词与相关功能一起出现的权利要求之外，并非针对任一权利要求均采用方式加功能或其他功能性的保护。落入权利要求的含义和范围内的对实施方式的每项添加、删除和修改都将被权利要求所包含。
如本文所用的术语“近似”、“大约”和“大致”用于表示仍然能执行期望的功能或获得期望的结果的接近所述量的量。例如，术语“近似”、“大约”和“大致”可以指在小于所述量的5％以内、1％以内、0.1％以内以及0.01％以内的量。此外，应该理解，在前面的描述中的任何方向或参考系仅仅是相对方向或运动。例如，对“上”和“下”或“上方”或“下方”的任何引用仅仅是对相关元件的相对位置或移动的描述。
在不脱离本公开的精神或特征的情况下，可以以其他具体形式来实施本公开。所描述的实施方式被认为是说明性的而非限制性的。因此，本公开的范围由所附权利要求而不是由前面的描述来指示。在权利要求的等同含义和范围内的改变将被包含在权利要求的范围内。

Claims (20)

1.一种血管内装置，所述装置包括：
长形本体，所述长形本体具有近端和远端，所述长形本体的至少一部分由本体材料制成并且所述长形本体具有在所述近端与所述远端之间的长度；
主管腔，所述主管腔由所述长形本体限定并且从所述近端延伸到所述远端；
多个辅助管腔，所述多个辅助管腔由所述长形本体限定并且从所述近端延伸穿过所述长形本体的长度的至少一部分，所述辅助管腔在横截面中相对于所述主管腔固定；以及
加强层，所述加强层连接至所述长形本体，所述加强层包括具有比所述本体材料的弹性模量大的弹性模量的加强材料。
2.根据权利要求1所述的血管内装置，还包括外护套。
3.根据权利要求2所述的血管内装置，其中，所述外护套包括在远端区域中的第一材料和在近端区域中的第二材料，所述第一材料具有比所述第二材料的弹性模量低的弹性模量。
4.根据权利要求1所述的血管内装置，还包括在所述长形本体的远端部分中的不透射线材料。
5.根据权利要求1所述的血管内装置，其中，所述长形本体具有从所述近端至所述远端的沿着所述长度的统一外径。
6.根据权利要求1所述的血管内装置，其中，所述长形本体是一体式挤压本体。
7.根据权利要求1所述的血管内装置，还包括位于所述主管腔中的压缩线圈。
8.根据权利要求7所述的血管内装置，其中，所述压缩线圈从所述近端延伸到所述远端。
9.根据权利要求1所述的血管内装置，其中，所述多个辅助管腔中的至少两个辅助管腔相对于所述主管腔大致彼此相对地定位。
10.一种血管内装置，所述装置包括：
长形本体，所述长形本体具有近端和远端，所述长形本体的至少一部分由本体材料制成并且所述长形本体具有在所述近端与所述远端之间的长度；
主管腔，所述主管腔由所述长形本体限定并且从所述近端延伸到所述远端；
多个辅助管腔，所述多个辅助管腔由所述长形本体限定并且从所述长形本体的所述近端延伸到所述远端，所述辅助管腔在横截面中相对于所述主管腔固定；以及
医疗装置，所述医疗装置连接至所述长形本体的远端。
11.根据权利要求10所述的装置，其中，所述医疗装置是置换的心脏瓣膜。
12.根据权利要求10所述的装置，还包括控制线，所述控制线延伸穿过所述多个辅助管腔中的一个辅助管腔并且可操作地连接至所述医疗装置。
13.根据权利要求12所述的装置，其中，将纵向力施加到所述控制线上以向所述医疗装置施加力，导致所述医疗装置的一部分相对于所述长形本体的远端移动。
14.根据权利要求10所述的装置，还包括连接至所述长形本体的加强层，所述加强层包括具有比所述本体材料的弹性模量大的弹性模量的加强材料。
15.一种递送导管系统，所述系统包括：
管身，所述管身包括：
长形本体，所述长形本体具有近端和远端，所述长形本体的至少一部分由本体材料制成并且所述长形本体具有在所述近端与所述远端之间的长度；
主管腔，所述主管腔由所述长形本体限定并且从所述近端延伸到所述远端；
多个辅助管腔，所述多个辅助管腔由所述长形本体限定并且从所述近端延伸穿过所述长形本体的长度的至少一部分，所述辅助管腔在横截面中相对于所述主管腔固定；以及
加强层，所述加强层连接至所述长形本体，所述加强层包括具有比所述本体材料的弹性模量大的弹性模量的加强材料；
手柄，所述手柄可操作地连接至所述长形本体的近端；以及
控制线，所述控制线连接至所述手柄并且从所述长形本体的近端穿过所述多个辅助管腔中的至少一个管腔延伸至所述长形本体的远端。
16.根据权利要求15所述的系统，还包括定位在所述线的至少一部分与所述线所延伸穿过的所述辅助管腔的表面之间的衬套材料。
17.根据权利要求15所述的系统，还包括连接至所述管身的远端的医疗装置。
18.根据权利要求15所述的系统，其中，所述管身的远端包括位于所述管身上的不透射线的标记。
19.根据权利要求15所述的系统，还包括定位在所述长形本体的外表面上外护套，并且所述外护套沿着所述长形本体的长度的至少一部分延伸。
20.根据权利要求15所述的系统，其中，所述手柄构造成对所述线施加纵向力。
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