CN109906099A - 用于引入和操纵多个伸缩导管的设备 - Google Patents

用于引入和操纵多个伸缩导管的设备 Download PDF

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CN109906099A
CN109906099A CN201780067818.7A CN201780067818A CN109906099A CN 109906099 A CN109906099 A CN 109906099A CN 201780067818 A CN201780067818 A CN 201780067818A CN 109906099 A CN109906099 A CN 109906099A
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bracing wire
layer
axis
incompressible
delivery device
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M·T·温斯顿
C·J·奥尔森
A·L·迈特彻克
T·D·特然
A·J·西格尔
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Edwards Lifesciences Corp
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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
    • 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
    • A61F2/2436—Deployment by retracting a sheath
    • 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
    • A61M25/0052—Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port
    • 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
    • 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
    • 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
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • 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
    • A61F2/243—Deployment by mechanical expansion
    • A61F2/2433—Deployment by mechanical expansion using balloon catheter
    • 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
    • A61M2025/0059—Catheters; Hollow probes characterised by structural features having means for preventing the catheter, sheath or lumens from collapsing due to outer forces, e.g. compressing forces, or caused by twisting or kinking
    • 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
    • A61M2025/015—Details of the distal fixation of the movable mechanical means
    • 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

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  • Heart & Thoracic Surgery (AREA)
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  • Vascular Medicine (AREA)
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Abstract

本申请公开一种递送设备，其包括可转向轴，该可转向轴具有近侧部分、远侧部分和延伸通过近侧部分和远侧部分的拉线管道。拉线延伸通过管道并具有固定到轴的远侧部分。调节机构连接到拉线的近端部分，并且被配置成增加和减小拉线中的张力以调节轴的曲率。轴的远侧部分具有包括一个或多个层的可转向部分。抗压缩部分被合并到可转向部分的层中，并且沿着该层的横截面的一部分成角度地延伸。合并有抗压缩部分的可转向部分的层具有第一刚度，并且抗压缩部分具有大于第一刚度的第二刚度。

Description

用于引入和操纵多个伸缩导管的设备
技术领域
本申请涉及可转向的(steerable)血管内递送装置的实施例。
背景技术
血管内递送装置用于各种程序中，以将假体/人造医疗装置或器械递送到身体内部的位置，这些位置不容易通过手术或者在不需要手术的情况下进入。通过***并引导递送装置穿过身体中的通路或管腔(包括但不限于血管、食道、气管、胃肠道的任何部分、***，仅举几例)，可以实现进入身体内的目标位置。在一个具体示例中，人造心脏瓣膜可以以卷曲状态安装在递送装置的远端上并且被推进通过患者的脉管***(例如，通过股动脉)，直到人造瓣膜到达心脏的植入部位。人造瓣膜然后被扩张至其功能尺寸，诸如通过使安装有人造瓣膜的球囊膨胀，或者通过从递送装置的护套部署人造瓣膜，使得人造瓣膜能够自扩张至其功能尺寸。
递送装置的有用性在很大程度上受到装置成功地导航通过小血管和绕脉管***中的急转弯导航的能力的限制，诸如导航通过下腔静脉或绕主动脉弓导航。已经采用各种技术来调节递送装置的部段的曲率，以帮助使瓣膜“转向”通过脉管***中的弯曲。通常，递送装置采用拉线，该拉线具有牢固地固定到可转向部段的远端和可操作地连接到位于体外的递送装置的手柄上的调节旋钮的近端。拉线通常被设置在拉线管腔中，该拉线管腔在递送装置的壁(例如护套或导管)中或邻近递送装置的壁纵向延伸。调节该调节旋钮(例如旋转旋钮)在拉线上施加拉力，这又使得可转向部段弯曲。
许多引导护套的缺点是它们在偏转或挠曲(flex)时易于发生不希望的变形。例如，受到显著曲率(诸如当以经间隔(transseptal)方式进入二尖瓣时)的引导护套可能沿着曲率的半径在一个或多个位置处扭结，从而大幅度减小引导护套的内直径并导致引导护套的远端的不可预测的移动。挠曲的引导护套也可以“平展”，其中导管的横截面由于护套的相邻层的材料之间缺乏粘附而椭圆化。另外，由于轴被挠曲时轴的轴向压缩，挠曲的引导护套的长度可能被减小或被缩短。(特别是在远端处的)引导护套的这种变形可能干扰植入物在治疗部位的精确定位。因此，需要改进的可转向轴装置。
发明内容
本公开的某些实施例涉及具有可转向轴的递送设备。在代表性实施例中，递送设备包括可转向轴，该可转向轴具有近侧部分、远侧部分和拉线管道，该拉线管道至少部分地延伸通过轴的近侧部分和远侧部分。递送设备进一步包括拉线，该拉线延伸通过拉线管道并具有近端部分和远端部分。拉线的远端部分被固定到轴的远侧部分。递送设备进一步包括调节机构，该调节机构可操作地连接到拉线的近端部分并且被配置成增加和减小拉线中的张力以调节轴的远侧部分的曲率。轴的远侧部分包括具有一个或更多个层的可转向部分。该可转向部分包括合并到可转向部分的相应层中并沿着该层的横截面的一部分成角度地延伸的抗压缩部分。合并有抗压缩部分的可转向部分的层具有第一刚度，并且抗压缩部分具有大于第一刚度的第二刚度。
在另一代表性实施例中，一种方法包括将递送设备的轴***患者体内，该轴具有近侧部分、远侧部分和拉线管道，该拉线管道至少部分地延伸通过近侧部分和远侧部分。拉线延伸通过拉线管道，并且轴的远侧部分包括具有一个或更多个层的可转向部分。可转向部分包括抗压缩部分，该抗压缩部分合并到可转向部分的相应层中并沿着该层的横截面的一部分成角度地延伸。合并有抗压缩部分的可转向部分的层具有第一刚度，并且抗压缩部分具有大于第一刚度的第二刚度。该方法进一步包括向拉线施加张力以调节轴的远侧部分的曲率。
在另一代表性实施例中，递送设备包括可转向轴，该可转向轴具有近侧部分、远侧部分和拉线管道，该拉线管道至少部分地延伸通过轴的近侧部分和远侧部分。递送设备进一步包括拉线，该拉线延伸通过拉线管道并具有近端部分和远端部分。拉线的远端部分被固定到轴的远侧部分。递送设备进一步包括调节机构，该调节机构可操作地连接到拉线的近端部分并且配置成增加和减小拉线中的张力以调节轴的远侧部分的曲率。轴的远侧部分包括一个或更多个层和合并到远侧部分的相应层中的抗压缩部分。抗压缩部分沿着层的横截面的一部分成角度地延伸，并且抗压缩部分的刚度大于合并有抗压缩部分的层的刚度。抗压缩部分沿着层的横截面从拉线管道成角度地偏移。
通过参考附图进行的以下详细描述，所公开技术的前述和其他目的、特征和优点将变得更加明显。
附图说明
图1是递送设备的代表性实施例的透视图。
图2是图1的递送设备的引导护套的侧视图。
图3是图1的引导护套的远侧部分的横截面侧视图，其示出了防损伤尖端部分和耦接部分。
图4是沿着图2的线4-4截取的图1的引导护套的横截面视图。
图5是示出了拉环和耦接到拉环的拉线的远侧部分的侧视图。
图6是图1的引导护套的远侧部分的平面视图，其示出了引导护套的各个层。
图7是图1的引导护套的远侧部分的透视图，其示出了外层的抗压缩部分。
图8是沿着图2的线8-8截取的图1的引导护套的横截面视图。
图9是图8的引导护套的拉线管道接收部分的细节视图。
图10是沿着图2的线10-10截取的图1的引导护套的横截面视图。
图11是图1的引导护套的透视图，其示出了引导护套的挠曲。
图12是包括一根拉线的引导护套的替代实施例的横截面视图。
具体实施方式
在特定实施例中，可用于将医疗装置、工具、药剂或其他治疗递送到受试者体内的位置的递送设备可以包括一个或多个可转向导管或护套。可转向导管或护套可用的程序的示例包括神经、泌尿、妇科、生育(例如，体外受精、人工授精)、腹腔镜、关节镜、经食道、经***、经膀胱、经直肠，以及包括进入任何体道或体腔的程序。特定示例包括放置植入物，植入物包括支架、移植物、栓塞线圈和类似物；定位成像装置或其部件，包括超声换能器；并且定位能量源(例如，用于执行碎石术)、RF源、超声发射器、电磁源、激光源、热源和诸如此类。
在一些实施例中，递送设备包括可转向轴，诸如引导护套，其具有同轴地设置在引导护套内的一个或多个递送导管。在某些配置中，递送导管可以包括在导管的远端部分处或附近的一个或更多个球囊。在一些实施方式中，递送设备可以用于将医疗装置递送通过脉管***，诸如递送到受试者的心脏。这些装置可以包括一个或更多个偏心定位的拉线，该拉线被配置成使得可转向轴沿给定方向弯曲或伸直。可转向轴可以进一步包括位于轴的远端附近的可转向部分，该可转向部分包括抗压缩部分，该抗压缩部分减小轴的缩短并增加对于由拉线施加到轴上的给定拉力可达到的弯曲度/曲率度数(degree of curvature)，从而提高了递送设备的可转向性。
图1示出了递送设备100的代表性实施例，该递送设备100包括手柄部分102和配置为可转向引导护套104的轴。递送设备100可以用于执行需要进入患者体内的目标位置的任何诊断、治疗或介入程序。例如，递送设备100可以用于在体内递送和部署假体装置、将工具递送到体内的目标位置、或递送或引入药物或其他药剂，仅举几个示例性用途。
在某些实施例中，递送设备可以包括同轴设置在引导护套104内并可相对于引导护套104移动的一个或更多个导管。例如，在所示的配置中，递送设备包括中间导管和内导管，该中间导管被配置作为设置在引导护套104内的可转向导管106，该内导管被配置为同轴设置在可转向导管106内的递送或植入导管108。植入导管108可以具有以径向压缩状态安装在植入导管的远端上的假体装置110。在所示的配置中，假体装置110是安装在植入导管的远端处的可膨胀球囊112上的人造心脏瓣膜，并且递送设备可以被配置成将人造心脏瓣膜110递送到心脏(主动脉、二尖瓣、肺动脉或三尖瓣)的自体瓣膜中的一个。
在一个具体示例中，人造心脏瓣膜110可以是塑性可扩张的人造心脏瓣膜，并且可膨胀球囊112可以被配置为在治疗部位处扩张和部署瓣膜110。在美国专利申请公开US2013/0030519、US2009/0281619、US2008/0065011和US2007/0005131中进一步公开了球囊112和植入导管108的示例性配置。在美国专利申请公开US2010/0036484和US2012/0123529中公开了示例性塑性可扩张人造心脏瓣膜。
在另一个示例中，递送设备100可以用于递送和部署可自扩张人造心脏瓣膜(例如，具有由形状记忆材料形成的框架的人造瓣膜，形状记忆材料诸如镍钛合金)。为了递送可自扩张人造瓣膜，人造瓣膜可以以径向压缩状态装载到递送护套或套管中，并且从目标位置处的护套的远侧开口端推进，以允许人造瓣膜扩张至其功能尺寸。递送护套可以是植入导管108的远端部分，或者是延伸通过引导护套104的另一个轴的远端部分。关于可自扩张人造瓣膜和用于可自扩张人造瓣膜的递送装置的进一步细节在美国专利申请公开US2010/0049313和US2012/0239142中公开。另外，应该理解的是，递送设备100可以用于递送任何各种其他可植入装置，诸如对接装置、小叶夹等。
参见图1和图2，可转向引导护套104可以包括远侧部分116和耦接到手柄部分102的近侧部分114。远侧部分116可以包括低硬度的防损伤尖端部分118，其被耦接到位于防损伤尖端118近侧的耦接部分120。在某些配置中，防损伤尖端118可以是不透射线的。引导护套104的远侧部分114可以包括可转向部分122，该可转向部分122位于耦接部分120的近侧并且被配置成挠曲和不挠曲以调节引导护套的远侧部分的曲率，如下面详细描述的。
图3至图10更详细地示出了引导护套104的构造，特别是远侧部分116的构造。引导护套104的曲率可以通过一个或更多个偏心定位的拉线来控制(参见例如图3、图5和图8)。例如，在所示的配置中，引导护套104包括纵向延伸通过相应的拉线管腔或管道128、130的两根拉线124、126。组装的拉线124、拉线126和管道128、管道130可以被设置在引导护套的拉线管道部分154中。在所示的配置中，拉线管道部分154至少部分地由引导护套的内层134的凹槽142限定。在所示的配置中，凹槽142可以延伸到引导护套104的内直径D1中，但是其他配置也是可能的。在某些实施例中，拉线管道128、拉线管道130可以由润滑材料制成，诸如聚四氟乙烯(PTFE)，以在拉线在管道内移动时减小拉线124、126与相应管道128、130之间的摩擦。
拉线124、126可以在一端耦接到嵌入在耦接部分120中的拉环144，并且在相对端耦接到控制机构，该控制机构被配置为手柄102的可旋转旋钮132(参见图1)。旋钮132的旋转可以增加和减小拉线124、126中的张力，这又可以使得远侧部分116(特别是可转向部分122)挠曲和不挠曲，以控制引导护套的曲率。图4中示出了耦接部分122的横截面视图，其示出了封装在耦接部分中的拉环144。
拉环144和拉线124、126的远侧部分在图5中单独示出。在所示的配置中，拉环144可以限定围绕其圆周多个开口156。在制造引导护套104期间，耦接部分120的聚合物材料可以在拉环144上回流，并且材料可以流动穿过开口156以将拉环封装在耦接部分中，如图3所示。另外，尽管所示的实施例包括两根拉线124、126，但应该理解，其他配置也是可能的。例如，引导护套104可以包括任何合适数量的具有任何合适尺寸或布局的拉线，包括单根拉线(参见图12)或多于两根拉线，这取决于装置的要求。本文示出的特定实施例包括两根拉线，因为在一些配置中，与用于将给定力传递到拉环144的单根较大拉线相比，两根拉线可以占据更小的横截面积，特别是当需要相对大的力时(诸如当挠曲装载有可转向导管106和植入导管108的引导护套时)。
参见图3至图10，引导护套104可以包括多个层，该多个层包括沿着引导护套的长度在不同位置处的各种不同材料，并且配置成赋予引导护套各种性质。例如，参见图3和图6，引导护套104的可转向部分122包括限定引导护套104的内直径D1的第一内层134，以及径向设置在内层134的外侧的第二拉线管道封装层135。第三螺旋盘绕层136在拉线管道封装层135上延伸。第四编织层138被设置在螺旋盘绕层136上，并且第五外层140被设置在编织层上并限定引导护套的外直径D2。图6示出了引导护套104的远侧部分116的平面视图，其中外层140、编织层138、螺旋盘绕层136和拉线管道封装层135中的每一个被示为部分地移除以示出引导护套的构造。
第一层134沿着引导护套104的整个长度延伸，并且可以由润滑材料(例如，PTFE)制成(或涂覆有润滑材料)，以允许可转向中间导管106相对于引导护套104在引导护套的管腔内滑动。如上所述，第一层134还可以限定拉线管道部分154的凹槽142，其中拉线124、126和管道128、130被接收在拉线管道部分154的凹槽142中。
拉线管道封装层135可以被设置在第一内层134和螺旋盘绕层136之间，并且可以具有围绕引导护套的周界成角度地变化的厚度。例如，参见图8和图9，拉线管道封装层135的靠近拉线管道部分154的部分可以足够厚，使得层135将拉线管道128、130封装在拉线导管部分中。同时，拉线管道封装层135的与拉线管道部分154相对的部分可以相对较薄。可替代地，拉线管道封装层135可以仅围绕引导护套的横截面的一部分延伸，诸如围绕包括拉线管道128、管道130的部分(例如，一半)延伸。在这样的配置中，螺旋盘绕层136可以沿着与拉线管道相对的内层的横截面的部分直接接触内层134，并且可以沿着拉线管道封装层起源的内层134的周界的位置处在拉线管道封装层135上过渡。在一些实施例中，拉线管道封装层135可以由任何合适的聚合物制成，诸如各种聚醚嵌段酰胺(例如，)中的任一种。在某些配置中，拉线管道封装层135可以从耦接部分120的近端延伸通过可转向部分122，到达拉线出口148(图2)。
螺旋盘绕层136可以由例如螺旋包裹或缠绕在拉线管道封装层135或第一层134周围的线形成。在所示的实施例中，螺旋盘绕层136可以从邻近拉环144向近侧延伸通过耦接部分120和可转向部分122到达位于近侧部分114和远侧部分116之间的过渡区域146(图1)。在某些实施例中，螺旋盘绕层136结束的过渡区域146可以是外层140从具有相对较高的硬度或刚度的材料(例如，63D)变为具有相对较低的硬度的材料(例如，聚酰胺，诸如)的位置。在一些实施例中，使轴的外层140或其他层的刚度沿着其长度逐渐改变(例如，逐步地)可以减小在挠曲期间或者当遍历身体的血管时的轴的扭结、断裂或歪曲的可能性。另外，在某些示例中，螺旋盘绕层136可以由例如以每英寸50圈间距0.020英寸缠绕的不锈钢或钛扁线制成，并且可以被配置成抵抗引导轴104(当其挠曲时)，特别是可转向部分122的扭结或挤压。
编织层138可以在螺旋盘绕层136上延伸。在所示的配置中，编织层138可以从靠近拉环144的耦接部分120向近侧延伸到例如拉线出口148。编织层138可以是例如以图案编织在一起以在螺旋盘绕层136上形成管状层的金属线。例如，在所示的实施例中，编织层138由以1上1下(over 1under 1)的图案编织的不锈钢或钛扁线制成，但是可以使用任何合适的编织图案。例如，在另一代表性实施例中，编织层138的线可以编织成1线在2线上在2线下(1over 2,under 2)的图案，纬计数为每英寸60纬纱(PPI)。编织层138可以被配置成例如抵抗引导护套104的不期望的扭转变形，以允许引导护套传递扭矩，这可以帮助将植入物定位在治疗部位处。编织层138还可以为引导护套104提供抗挤压或抗扭结性能。在所示的配置中，耦接部分120还可以包括设置在拉环144下方的编织层158，如图3和图4所示。
外层140可以包括例如多种聚合物材料中的任何一种，诸如聚酰胺(例如)、聚醚嵌段酰胺(例如)、尼龙或任何其它合适的生物相容性聚合物或沿着其长度的以上材料的组合。在所示的配置中，拉线管道封装层135、螺旋盘绕层136和编织层138可以在引导护套104的近端的远侧终止。例如，在一些配置中，这些层可以在拉线出口148处终止。在拉线出口148的近侧，外层140的厚度可以增加，以沿着引导护套的长度保持基本均匀的外直径，如图10所示。
参见图7和图8，引导护套104的远侧部分116可以包括抗压缩部分150。在所示的配置中，抗压缩部分150被合并到外层140中，并且形成可转向部分122的相应部件。如图7中所示，抗压缩部分150可以沿着可转向部分122的长度L延伸。抗压缩部分150还可以沿外层140的横截面周向或成角度地延伸，或占据外层140的横截面的相应部分。例如，参见图8，抗压缩部分150沿外层140的横截面的角度范围由角度θ表示。在一些实施例中，角度θ可以是从10度至180度(或横截面的周界的一半)。在一些实施例中，角度θ可以是从10度至90度。在图8的实施例中，角度θ是60度。
在某些配置中，抗压缩部分150可以与拉线管道128、130相对设置。例如，在所示的配置中，抗压缩部分150从拉线管道部分154成角度地偏移180度，使得其位于与拉线管道128、130直径方向相对的位置。在这种配置中，将拉线管道部分154等分的平面152也将抗压缩部分150等分，如图8所示。在图8的包括两个拉线和管道的配置中，将拉线管道部分154等分的平面152在相应的管道128、130之间通过。然而，在包括单根拉线的配置中，诸如图12中所示的替代配置，单根拉线160和管道162可以与拉线管道部分154同轴对齐，使得将拉线管道部分154和抗压缩部分150等分的平面152也将拉线160和管道162等分。在其他配置中，抗压缩部分150可以根据需要沿着外层140的横截面从拉线管道部分154成角度地偏移例如90度到180度。
抗压缩部分150可以由具有比其中合并有抗压缩部分的可转向部分122中的外层140的其余部分相对更高的刚度或硬度的材料制成。例如，在某些实施例中，抗压缩部分150的硬度可以是可转向部分122中的外层140的其余部分的硬度的1.5倍至5倍。在一些实施例中，抗压缩部分150的硬度可以是可转向部分122中的外层140的其余部分的硬度的2倍至3倍。在示例性实施例中，抗压缩部分150可以由具有72D的硬度的制成，并且可转向部分122的外层140的其余部分可以由具有25D的硬度的制成，使得抗压缩部分150的硬度与可转向部分122中的外层140的其余部分的硬度的比率为2.9:1。在一些实施例中，抗压缩部分150的硬度与可转向部分122中的外层140的其余部分的硬度的比率可以是3:1。
在其他实施例中，抗压缩部分150可以由表现合适刚度特性的各种材料中的任何材料制成，包括金属(诸如不锈钢、钛、镍钛合金(诸如镍钛诺)、钴铬)或其他聚合物。另外，在某些配置中，抗压缩部分的厚度不必等于外层140的总厚度。例如，抗压缩部分150可以具有小于外层的总厚度的厚度，并且可以根据需要封装在外层内。抗压缩部分150的硬度也可以沿其长度变化。例如，抗压缩部分150的近侧部分可以具有比远侧部分相对更低的硬度，或反之亦然。
抗压缩部分150可以为引导护套104的可转向部分122提供各种有利特性。例如，抗压缩部分150的相对较高的硬度可以为可转向部分122提供轴向强度。当引导导管挠曲时，这可以显著减少或防止引导护套104(特别是可转向部分122)的不希望的缩短。更具体地，当引导护套挠曲时，与其处于非偏转状态时相比，抗压缩部分150可以减小引导护套的轴向压缩和材料的相关起皱。当材料变形时，材料的这种轴向压缩和起皱会减小引导护套104的长度，并且可能损坏引导护套。通过减小或消除引导护套104在其挠曲时的缩短，抗压缩部分150可以减少操作者(例如，通过使递送设备通过患者的脉管***推进或缩回)纵向重新定位递送设备的需要，以便在挠曲引导护套之后在治疗部位处获得或重新获得植入物的期望方位。
另外，抗压缩部分150与拉线管道128、130成角度地偏移的位置可以有助于引发引导护套的可转向部分122沿指定方向的变形。例如，当抗压缩部分150位于拉线管道128、130的对面时，当引导护套挠曲时，抗压缩部分的轴向刚性可以引起可转向部分122在远离抗压缩部分的方向上的偏转，如图11所示。当护套挠曲时，抗压缩部分150还可以通过减少护套的不同层相对于彼此的纵向移动来减少或防止引导护套的椭圆化(也称为“平展化(pancake)”)，尤其是在一个或多个构成层(例如，PTFE层，诸如内层134)没有牢固地粘附到(一个或更多个)周围层的情况下。
抗压缩部分150还可以增加对于由拉线124、126施加到远侧部分的给定力可达到的远侧部分116的挠曲程度，而不会损坏引导护套。远侧部分116的挠曲角度被表示为α，并在图11中示出。例如，通过减少引导护套104的缩短，由拉线124、126施加的更大比例的力可用于挠曲引导护套而不是弹性地压缩引导护套。另外，抗压缩部分150可以减少或防止伴随着引导护套104挠曲时的缩短而产生的拉线124、126的松弛，因而导致与典型的引导护套相比，对于给定的拉线行程可达到更大程度的曲率。如本文所使用的，术语“拉线行程”是指当拉力施加到拉线时沿拉线长度的给定点相对于静止参考(例如，拉线管道)移动的线性距离。
另外，抗压缩部分150与上述描述的螺旋盘绕层136和编织层138一起可以提供显著的协同优势，即改善了引导护套104相对于已知的可转向护套和导管的性能。例如，无负载引导护套(例如，没有递送导管或延伸穿过其管腔的其他轴的引导护套)的远侧部分具有22Fr的内直径并且包括抗压缩部分、螺旋盘绕层和编织层特征，该无负载引导护套的远侧部分在拉线施加175N的力的作用下能够挠曲接近355度而不会扭结，并且没有显著的缩短。在该示例中，需要50mm的拉线行程以将175N的力施加到引导护套的远侧部分。相比之下，对于没有抗压缩部分并且没有递送导管或延伸穿过其管腔的其他护套的典型可转向导管装置，175N的力产生270度的挠曲并且需要60mm的拉线行程，并且可能预计引导器护套缩短6mm至10mm。
在另一示例中，引导护套的远侧部分具有22Fr的内直径并且包括上述的抗压缩部分、螺旋盘绕层和编织层特征，并且装载有递送导管和在引导护套的管腔内同轴延伸的植入导管，该引导护套的远侧部分在拉线施加250N的力的作用下能够挠曲270度而不会扭结，并且没有显著的缩短。在该示例中，需要40mm的拉线行程以将250N的力施加到引导护套的远侧部分。相比之下，对于没有抗压缩部分且装载有递送导管和植入导管的可转向导管装置，250N的力产生180度的挠曲并且需要70mm的拉线行程，并且可能预计引导护套缩短6mm至10mm。
在使用中，可以使用任何已知的递送技术将递送设备100引入并推进通过患者的脉管***。在经股动脉程序中，递送设备可以被***通过股动脉和主动脉以进入心脏(通常，但不仅仅用于主动脉瓣膜置换)。在经中隔程序(通常用于主动脉瓣或二尖瓣置换)中，递送装置可以诸如经由股静脉被推进到右心房，并被推进通过分隔右心室和左心室的隔膜。所公开的实施例对于将人造瓣膜递送到天然二尖瓣特别有用，因为引导护套104的可扭转性和远侧部分116可实现的相对高的弯曲度允许人造瓣膜精确定位在目标部位处，尽管存在曲折路径，但在某些方法中，递送装置必须遵循以进入二尖瓣。在经心室程序中，递送设备可以被***通过在心室下前壁(lower anterior ventricle wall)上的裸点上形成的手术切口(通常，但不仅仅用于主动脉或二尖瓣置换)。在经心房程序中，递送设备可以被***通过在左心房或右心房壁中形成的手术切口。在经主动脉程序中，递送设备可以被***通过在升主动脉中制成的手术切口并朝向心脏推进(通常，但不仅仅用于主动脉瓣膜置换)。
在这些程序的某些程序中，抗压缩部分150、螺旋盘绕层136和编织层138的组合可以有助于将假体装置(诸如心脏瓣膜110)精确地定位在治疗部位。例如，在进入二尖瓣的经间隔程序中，在递送设备的远端推进到治疗部位之后，引导护套104的远侧部分116可以挠曲以使人造瓣膜110与二尖瓣轴向对齐(例如，在某些示例中为180度或更大)。当远侧部分116处于挠曲状态时，引导护套104也可以被扭转以使人造瓣膜110相对于二尖瓣径向定位。抗压缩部分150、螺旋盘绕层136和编织层138的组合可以允许引导护套挠曲而没有显著的缩短或扭结，并且可以允许引导护套扭转而没有轴的不期望的扭转变形或引导护套的相关的不可预测的旋转运动。
应当理解，在替代配置中，可以在不脱离本公开的精神的情况下重新布置所公开的递送设备实施例的部件。例如，螺旋盘绕层136和编织层138的位置可以颠倒，使得螺旋盘绕层位于编织层的顶部。可替代地，螺旋盘绕层136和编织层138可以通过一个或更多个中间层彼此分开。另外，抗压缩部分150不需要是外层140的相应部分，而是可以被合并到引导护套104中的任何合适的层中。抗压缩部分150也不需要沿可转向部分122的整个长度延伸，而是可以沿可转向部分的任何合适部分延伸。本文所述的所公开的抗压缩部分、螺旋盘绕层和编织层特征也可适用于其他类型的可转向导管装置，诸如递送导管。
一般考虑因素
出于本说明书的目的，本文描述了本公开的实施例的某些方面、优点和新颖特征。所公开的方法、设备和***不应被解释为以任何方式进行限制。相反，本公开针对各种公开的实施例的单独和各种组合和彼此子组合的所有新颖和非显而易见的特征和方面。方法、设备和***不限于任何特定方面或特征或其组合，所公开的实施例也不要求存在任何一个或多个特定优点或解决问题。
尽管为了方便呈现，以特定的顺序次序描述了一些公开的实施例的操作，但是应该理解，这种描述方式包括重新排列，除非下面阐述的特定语言需要特定的排序。例如，在某些情况下，顺序描述的操作可以重新排列或同时执行。此外，为了简单起见，附图可能未示出所公开的方法可以与其他方法结合使用的各种方式。另外，该描述有时使用如“提供”或“实现”之类的术语来描述所公开的方法。这些术语是执行的实际操作的高级抽象。对应于这些术语的实际操作可以根据具体实施方式而变化，并且本领域普通技术人员可以容易地辨别。
如在本申请和权利要求中所使用的，单数形式“一”、“一个”和“该”包括复数形式，除非上下文另有明确规定。另外，术语“包含”表示“包括”。此外，术语“耦接”和“相关联”通常表示电、电磁或物理(例如，机械或化学)耦接或链接，并且不排除在没有特定相反语言情况下耦接或相关联项目之间存在中间元素。
在本申请的上下文中，术语“下”和“上”分别与术语“流入”和“流出”互换使用。因此，例如，瓣膜的下端是其流入端，瓣膜的上端是其流出端。
如本文所使用的，术语“近侧”是指更靠近使用者并且更远离植入部位的装置的位置、方向或部分。如本文所使用的，术语“远侧”是指远离使用者并且更靠近植入部位的装置的位置、方向或部分。因此，例如，装置的近侧运动是装置朝向使用者的运动，而装置的远侧运动是装置远离使用者的运动。术语“纵向”和“轴向”是指沿近侧方向和远侧方向延伸的轴线，除非另有明确定义。
除非另有说明，否则在说明书或权利要求中使用的表示部件数量、距离、力、比率、角度、百分比等的所有数字应理解为由术语“约”修正。因此，除非另外暗示地或明确地说明，否则所述数值参数是近似值，其取决于所寻求的期望性质和/或在本领域普通技术人员熟悉的测试条件/方法下的检测限度。当直接且明确地将实施例与所讨论的现有技术区分开时，除非引用词语“约”，否则实施例数字不是近似的。此外，并非本文所述的所有替代方案都是等同的。
鉴于可以应用所公开技术的原理的许多可能的实施例，应该认识到，所示实施例仅是优选示例，并且不应被视为限制本公开的范围。相反，本公开的范围至少与随附的权利要求一样宽。

Claims (20)

1.一种递送设备，其包括：
可转向轴，其包括近侧部分、远侧部分和拉线管道，所述拉线管道至少部分地延伸通过所述轴的所述近侧部分和所述远侧部分；
拉线，其延伸通过所述拉线管道并具有近端部分和远端部分，其中所述拉线的所述远端部分被固定到所述轴的所述远侧部分；
调节机构，其可操作地连接到所述拉线的所述近端部分，并且被配置成增加和减小所述拉线中的张力，以调节所述轴的所述远侧部分的曲率；并且
其中所述轴的所述远侧部分包括具有一个或更多个层的可转向部分，所述可转向部分包括抗压缩部分，所述抗压缩部分被合并到所述可转向部分的相应层中并沿着所述层的横截面的一部分成角度地延伸，其中合并有所述抗压缩部分的所述可转向部分的层具有第一刚度，所述抗压缩部分具有大于所述第一刚度的第二刚度。
2.根据权利要求1所述的递送设备，其中所述抗压缩部分位于所述拉线管道的对面。
3.根据权利要求1或权利要求2所述的递送设备，其中所述抗压缩部分沿着第二层的横截面从10度到180度延伸。
4.根据权利要求3所述的递送设备，其中所述抗压缩部分沿着所述第二层的所述横截面延伸60度。
5.根据权利要求1-4中任一项所述的递送设备，其中：
所述轴包括限定所述轴的内直径的第一内层；并且
其中合并有所述抗压缩部分的所述层是限定所述轴的外直径的第二外层。
6.根据权利要求5所述的递送设备，其中所述轴进一步包括在所述内层和所述外层之间的第三螺旋盘绕层。
7.根据权利要求6所述的递送设备，其中所述轴进一步包括编织在所述螺旋盘绕层的至少一部分上的第四编织层。
8.根据权利要求7所述的递送设备，其中所述轴进一步包括在所述内层和所述螺旋盘绕层之间的拉线管道封装层，所述拉线管道封装层封装所述拉线管道。
9.根据权利要求5所述的递送设备，其中所述内层限定凹槽，所述凹槽被配置成接收所述拉线管道。
10.根据权利要求9所述的递送设备，其中：
所述拉线是第一拉线；
所述拉线管道是第一拉线管道；并且
所述轴进一步包括接收在第二拉线管道中的第二拉线，所述第二拉线管道被设置成邻近所述凹槽中的所述第一拉线管道。
11.根据权利要求1-10中任一项所述的递送设备，其中所述第二刚度与所述第一刚度的比率为1.5:1至5:1。
12.根据权利要求11所述的递送设备，其中所述比率为3:1。
13.根据权利要求1-12中任一项所述的递送设备，其中所述轴是引导护套，并且所述递送设备进一步包括同轴设置在所述引导护套内的植入导管，所述植入导管包括安装在所述植入导管的远端上的人造瓣膜。
14.一种方法，其包括：
将递送设备的轴***患者体内，所述轴具有近侧部分、远侧部分和拉线管道，所述拉线管道至少部分地延伸通过所述近侧部分和所述远侧部分，拉线延伸通过所述拉线管道，所述轴的所述远侧部分包括具有一个或更多个层的可转向部分，所述可转向部分包括抗压缩部分，所述抗压缩部分被合并到所述可转向部分的相应层中并沿着所述层的横截面的一部分成角度地延伸，合并有所述抗压缩部分的所述可转向部分的层具有第一刚度，所述抗压缩部分具有大于所述第一刚度的第二刚度；并且
向所述拉线施加张力以调节所述轴的所述远侧部分的曲率。
15.根据权利要求14所述的方法，进一步包括：在将所述轴***体内之后，并且在调节所述轴的所述远侧部分的所述曲率之后，扭转所述轴以旋转所述轴的所述远侧部分。
16.根据权利要求14或权利要求15所述的方法，进一步包括：
将人造瓣膜以径向压缩状态安装在植入导管的远端上，所述植入导管同轴地延伸通过所述轴；
在将所述轴***患者体内时，将所述人造瓣膜***体内；并且
在体内部署所述人造瓣膜。
17.一种递送设备，其包括：
可转向轴，其包括近侧部分、远侧部分和拉线管道，所述拉线管道至少部分地延伸通过所述轴的所述近侧部分和所述远侧部分；
拉线，其延伸通过所述拉线管道并且具有近端部分和远端部分，其中所述拉线的所述远端部分被固定到所述轴的所述远侧部分；
调节机构，其可操作地连接到所述拉线的所述近端部分，并且被配置成增加和减小所述拉线中的张力，以调节所述轴的所述远侧部分的曲率；并且
其中所述轴的所述远侧部分包括一个或更多个层和合并到所述远侧部分的相应层中的抗压缩部分，所述抗压缩部分沿着所述层的横截面的一部分成角度地延伸，并且所述抗压缩部分的刚度大于合并有所述抗压缩部分的层的刚度，所述抗压缩部分沿着所述层的所述横截面从所述拉线管道成角度地偏移。
18.根据权利要求17所述的递送设备，其中所述抗压缩部分位于所述拉线管道的对面。
19.根据权利要求17或权利要求18所述的递送设备，其中所述抗压缩部分沿着合并有所述抗压缩部分的所述层的所述横截面从10度到180度延伸。
20.根据权利要求17-19中任一项所述的递送设备，其中所述抗压缩部分的所述刚度与合并有所述抗压缩部分的所述层的所述刚度的比率为1.5:1至5:1。
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US11517718B2 (en) 2022-12-06
US20200269017A1 (en) 2020-08-27
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