CN103945898A - 用于可植入医疗装置的输送系统组件以及相关方法 - Google Patents

用于可植入医疗装置的输送系统组件以及相关方法 Download PDF

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CN103945898A
CN103945898A CN201280056592.8A CN201280056592A CN103945898A CN 103945898 A CN103945898 A CN 103945898A CN 201280056592 A CN201280056592 A CN 201280056592A CN 103945898 A CN103945898 A CN 103945898A
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W·A·贝尔蒂奥姆
H·A·斯泰因吉瑟
D·H·特兰
E·格里斯沃尔德
B·L·洛钦
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Medtronic Inc
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    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0587—Epicardial electrode systems; Endocardial electrodes piercing the pericardium
    • A—HUMAN NECESSITIES
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    • 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
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    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14276—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body specially adapted for implantation
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    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37205—Microstimulators, e.g. implantable through a cannula
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/375—Constructional arrangements, e.g. casings
    • A61N1/3756—Casings with electrodes thereon, e.g. leadless stimulators
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
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    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
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    • A61B2017/00318—Steering mechanisms
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • 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
    • A61M25/0041—Catheters; Hollow probes characterised by the form of the tubing pre-formed, e.g. specially adapted to fit with the anatomy of body channels
    • 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
    • A61M25/0102—Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/3621—Heart stimulators for treating or preventing abnormally high heart rate
    • A61N1/3622—Heart stimulators for treating or preventing abnormally high heart rate comprising two or more electrodes co-operating with different heart regions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/056—Transvascular endocardial electrode systems
    • A61N1/057—Anchoring means; Means for fixing the head inside the heart
    • A61N2001/0578—Anchoring means; Means for fixing the head inside the heart having means for removal or extraction

Abstract

一种输送系统组件包括细长外管、细长内部构件以及铰接套管，该细长内部构件在外管的内腔内延伸，而该铰接套管在组件的手柄和外管的最远部分之间围绕外管。外管能在套管内纵向地运动；且套管的内直径较佳地小于手柄的外直径和外管的最远部分的外直径。

Description

用于可植入医疗装置的输送系统组件以及相关方法
发明领域
本发明涉及可植入医疗装置的输送，并且更具体地涉及便于相对紧凑的可植入心脏医疗装置的经皮经静脉部署的系统组件和相关方法。
背景技术
典型的可植入心脏起搏器包括脉冲发生器，而一根或多根柔性细长引线联接于该脉冲发生器。该脉冲发生器通常相对于心脏远程地植入在皮下囊袋中，且一根或多根引线中的每根都从该脉冲发生器延伸至对应的电极、联接于该电极并定位在起搏部位处、即心内膜或心外膜处。有时与细长的引线相关联并且对于本领域技术人员众所周知的机械并发症和/或MRI兼容性问题激发了心脏起搏装置的发展，这些心脏起搏装置完全容纳在相对紧凑的包装内，用以紧邻于起搏位置地植入，例如在心脏的右心室(RV)内。参见图1，示出了此种装置100，其中，起搏/感测电极111、112形成在封壳的外表面上，该封壳气密地容纳包括脉冲发生器电子器件的脉冲发生器和电源。图1示出固定构件115，该固定构件在电极111的附近安装于装置100的封壳的端部，以抵靠于心内膜表面将电极111固定或稳固在右心室的心尖中。封壳101由诸如钛之类的可生物相容和生物稳定的金属形成，除了形成有电极112以成为囊101的露出部分的位置以外，该金属上覆盖有绝缘层、例如医疗级别的聚氨酯或硅酮。例如任何本领域技术人员已知的气密馈通组件(未示出)可将电极111联接于容纳在装置100的封壳内的脉冲发生器。
图1还示出了标准引导导管150的远侧部分，根据介入性心脏病学领域已知的方法将该标准引导导管向上操纵通过下腔静脉(IVC)并从右心房(RA)进入到RV中。虽然可采用导管150将装置100输送至右心室用以进行植入，但便于改进更适合于诸如装置100之类相对紧凑可植入装置的导入和部署的更复杂的输送系统也是期望的。
发明内容
根据本发明一些实施例，一种输送系统组件包括细长外管、细长内部构件以及铰接套管，该细长内部构件在由外管形成的内腔内延伸，而该铰接套管围绕外管。外管可在铰接套管内运动，使得外管可相对于铰接套管朝近侧和朝远侧纵向地运动。根据一些较佳的实施例，套管所具有的内直径小于外管的最远部分的外直径，并且小于输送系统组件的手柄的外直径，且外管从该手柄延伸出。
根据本发明的一些方法，通过铰接套管的偏转来定向外管的最远部分，并且通过随后外管相对于铰接套管的行进/延伸以使得最远部分运动至接近目标植入部位，来便于将输送系统组件导入并通过患者的静脉系统。根据一些实施例，铰接套管包括拉线构件，该拉线构件用于使得套管的远端偏转以定向外管的最远部分。根据一些替代实施例，铰接套管的远侧部段具有预成形曲率，其中该曲率首先被完全插在内部构件的内腔内的拉直心轴拉直，然后将其释放以使得套管偏转，以定向外管的最远部分。沿着外管的最远部分的长度而由外管形成的内腔将尺寸设计成容纳整个可植入医疗装置；而内部构件的远端较佳地构造成与医疗装置的近端相匹配以在如下位置处配合在最远部分内，该位置允许所配合的远端和整个医疗装置一起容纳在外管的最远部分内。当内部构件的远端配合在外管的最远部分内时，外管从近侧位置朝向远侧位置的行进/延伸致使内部构件进行类似的纵向运动。当外管例如经由组件的手柄的控制构件朝近侧缩回或运动时，内部构件的远端与最远部分脱开，以使得外管相对于铰接套管和内部构件独立于内部构件地运动。
附图说明
下面的附图是对本发明的具体实施例的说明，且因此不限制本发明的范围。各附图不按比例(除非指出)且旨在与下面的详细描述中的解释结合使用。下面将结合附图描述各实施例，其中，相同的附图标记表示相同的元件，附图中
图1是示出所植入的心脏刺激装置的示例的示意图；
图2A是根据一些实施例的输送系统组件的平面图；
图2B-C分别是根据一些实施例的、图2A所示系统组件的外部子组件和内部子组件的平面图；
图3是根据一些实施例的、包括详细的剖切截面的输送系统组件的另一平面图；
图4A是根据一些替代实施例的另一输送系统组件的平面图；
图4B是根据一些实施例的处于预成形状态的图4A所示系统组件的铰接套管的平面图；
图5是根据一些实施例的、包括详细的剖切截面的图4A所示输送系统组件的另一平面图；
图6A-C是示出根据一些实施例的处于各种导入状态的输送系统组件的各部分的示意图；以及
图7是概括本发明的一些方法的流程图，包括一些示意图。
具体实施方式
下面的详细描述在本质上仅仅是示例性的，但不意在以任何方式限制本发明的范围、应用或构造。相反，下文描述提供的是实践示例，且本领域技术人员会认识到其中一些示例可具有合适的替代。
图2A是根据一些实施例的输送系统组件200的平面图；而图2B-2C分别是根据一些实施例的输送系统组件200的外部子组件和内部子组件的平面图。图2A示出了包括手柄210的系统组件，该手柄具有控制构件212，且细长外管230从该手柄沿远侧方向延伸；而图2B示出了外管230的近端231，该近端插在控制构件212的环件内并且例如由UV(紫外线)固化粘结剂粘结于该环件。根据所示出的实施例，外管230形成内腔236(图3和5)，且细长内部构件250(图2C)在该内腔内延伸。图2B还示出了外管230从近端231延伸至最远部分235，该最远部分由外管230的远端232终止；并且应理解的是，由外管230形成的内腔236较佳地在近端231处具有近侧开口而在远端232处具有远侧开口。进一步参见图2A，该组件200还包括铰接套管220，该铰接套管在手柄210和最远部分235之间围绕外管230。根据本发明的各实施例，外管230可在铰接套管220内纵向地运动，且铰接套管220较佳地具有内表面228，该内表面与外管230隔开径向间隙，该径向间隙例如在大约0.002英寸和大约0.01英寸之间。图2A-B还示出了最远部分235相对于外管230的剩余部分扩大，且该最远部分所具有的外直径较佳地大致等于铰接套管220的外直径并且大于套管220的内直径，例如最远部分235在大约3.5cm(约1.4英寸)的长度上具有大约0.30英寸(约0.8cm)的外直径，而套管220的内直径是大约0.275英寸(约0.7cm)。例如当外管230并不缩回时(外管230的缩回会在下文进行描述)，手柄210和外管的最远部分235之间的最大距离较佳地是至少比铰接套管220的长度长大约10cm至11cm，例如，当铰接套管220的长度在大约85cm和大约95cm之间时，则该最大距离在大约95cm和大约110cm之间。例如下文结合图7所描述的，这些长度适合于从股动脉通入部位将外管的最远部分235导入到患者的右心房(RA)和右心室(RV)中。
图2A还示出了铰接套管220包括拉线构件205，该拉线构件从套管220的近端221朝近侧延伸并且由近侧控制端部215所终止。参见图3，该图3是包括剖切截面的组件200的平面图，拉线构件205在套管220的近端221和套管220的远端222之间延伸，并且包括锚固在远端222附近的远端225。根据所示出的实施例，当近侧控制端部215沿箭头d的方向被拉动时，拉线构件205使得套管220的远端222沿箭头D的方向偏转。图3还示出了可选的锁定构件245，该锁定构件安装于轴220的近端221，且例如是螺钉型紧固件，该螺钉型紧固件可固定抵靠于拉线构件205以保持拉线构件中的拉伸张力，从而保持套管220的偏转。根据一些较佳的实施例，套管220的轴包括304医疗级别的不锈钢编织物，该不锈钢编织物夹在相对较薄的内聚合物衬垫和聚合物外护套之间，该内聚合物衬垫例如由诸如6333之类的聚醚嵌段酰胺形成或者由高密度聚乙烯(HDPE)形成，而该聚合物外护套较佳地分成近侧部段和远侧部段，该外护套的远侧部段所具有的硬度比近侧部段所具有的硬度低，并且在大约3cm的长度上延伸。根据示例实施例，套管220的外护套的近侧部段由7233形成，而远侧部段由3533形成。拉线构件205可在形成于铰接套管220的壁内的内腔内延伸，该内腔例如由在套管220的内衬垫和外护套之间延伸的含氟聚合物管件形成；而拉线构件205的锚固远端225可形成为绕远端222的周缘延伸的环件，并且类似于上述不锈钢编织物那样夹在套管220的轴的内层和外层之间。
铰接套管220的近端221和远端222可形成为相对润滑的稳定构件227，或者如图3所示可包括相对润滑的稳定构件，该稳定构件形成与外管230的接合部，以便于外管230与手柄210一起或者相对于该手柄在套管220内进行顺畅的纵向运动，这将在下文进行更详细地描述。铰接套管220的近端221较佳地首先位于离手柄210向着远侧大约10cm的距离处，使得手柄210和外管230可例如在套管220的远端222发生上述偏转之后、相对于套管220沿箭头E(图3)一起行进足以将外管的远端232放置成紧邻于目标植入部位的距离，这将结合图6A-C在下文进行描述。远端222可首先位于距外管230的最远部分235大约1cm之内的位置处。
图2C和3还示出了细长内部构件250，该细长内部构件从该细长内部构件的近端251延伸至该细长内部构件的扩开远端252。虽然未示出，近端251可从手柄210朝近侧延伸通过夹持机构260(图2A)，该夹持机构例如由鲁尔配件(未示出)联接于手柄210。图3示出了内部构件250的远端252，该远端通过与内肩部233的面对面或邻抵的接合部配合在外管230的最远部分235内，从而当外管230沿箭头E运动时，最远部分235和内部构件250相对于铰接套管220沿远侧方向一起运动。进一步参见图3，由于内部构件250的远端252变得从最远部分235脱开，因而当控制构件212沿箭头r运动时，外管230独立于内部构件250并且相对于套管220和内部构件250沿箭头R朝近侧方向缩回或者纵向地运动。因此，外管230的缩回会露出装置100的固定构件115，用以部署该固定构件。根据一些替代实施例，采用内部构件250的可从手柄210朝近侧延伸出的近端252，以使得内部构件250相对于外管230运动。(应注意的是，替代的实施例可采用类似地使得内部构件250的远端252和最远部分235相配合和脱开的其它装置，这些其它装置允许外管230和内部构件250进行上述协调的远侧运动，并且允许外管230相对于内部构件250进行独立的近侧运动。)为了便于使得外管230相对于内部构件250运动，可沿着外管230和内部构件250的长度，将诸如MED361硅酮油之类的生物相容润滑剂施加到外管230和内部构件250之间，和/或施加到内部构件250的扩开远端252的外表面和外管230的最远部分235的内表面238之间。根据一些实施例，例如可由硅酮油润滑的O形圈类型的密封构件(即，硅酮；未示出)在手柄210内的外管230和内部构件250之间形成动态密封接合部。铰接套管220的构造可使得操作者能抓持在该铰接套管周围，以在不阻碍外管230运动的情形下缩回外管230，如上述相关美国专利申请系列号13/239,990(代理案卷号P0040842.USU1)中描述的稳定套管(250)。
进一步参见图3，整个可植入医疗装置100都被显示为容纳在外管230的最远部分235内，例如已经过外管230的内腔236中位于远端232处的远侧开口而被加载到该最远部分中。外管230的最远部分235可具有大约0.275英寸(约0.7cm)的内直径。图3还示出了装置100的近端121，该近端邻抵内部构件220的远端222，而该远端较佳地构造成与近端121相适配。远端252的此种适配构造可有助于在输送系统组件200的导入过程中并且在装置100从该输送系统组件中部署之前，将装置100保持在外管230的最远部分235内。根据示例实施例，扩开远端252由带有辐射不透的硫酸钡填充剂的聚醚嵌段酰胺、例如7033形成，而最远部分235也由聚醚嵌段酰胺、例如7233形成，该聚醚嵌段酰胺在远端232处包括夹在7233的各层之间的辐射不透带，该辐射不透带为75％钨和25％6033。根据所示出的实施例并且在下文将结合图6A－C更详细地描述的，当铰接套管220的拉线构件205沿箭头d致动以使得远端222沿箭头D偏转时，最远部分235被定向成便于组件200的导入，以部署装置100。
图4A是根据一些替代实施例的另一输送系统组件400的平面图；而图4B是根据一些实施例的处于预成形状态的系统组件400的铰接套管420的平面图。图4A示出了输送系统组件400，该输送系统组件包括外管230，类似于系统组件200，该外管从手柄210朝远侧延伸穿过套管420的内腔，且在该输送系统组件的近端231处联接于控制构件212。虽然在图4A中并未示出，系统组件400还包括内部构件450，该内部构件450类似于内部构件250并且将结合图5进行描述。图4A还示出了铰接套管420，该铰接套管在手柄210和外管230的最远部分235之间围绕外管230，其中，当套管420的远端422位于最远部分235近侧大约1cm时，套管420的近端421一开始从手柄210朝远侧隔开大约10cm。图4B示出了铰接套管420，该铰接套管包括具有预成形曲率的远侧部段424，而如图4A和5所示，该远侧部段在组件400中被完全插入的拉直心轴445拉直。
图5是根据一些实施例的包括详细剖切截面的输送系统组件400的另一平面图。图5示出了形成有内部内腔的内部构件450，拉直心轴445完全插在该内部内腔中，以将远侧部段424的预成形曲率拉直。心轴445较佳地由医疗级别的不锈钢形成，并且可具有在大约0.02英寸和大约0.04英寸(约0.5mm和约1mm)之间的直径以及在大约120cm和大约140cm之间的长度。该完全插入的心轴445被显示为从手柄210朝近侧延伸出，并朝远侧延伸超出套管420的远端422而至接近内部构件450的远端452。根据所示出的实施例，当例如在至少大约4cm的距离上沿箭头w将心轴445抽出时，远侧部段424的预成形曲率朝向图4B所示的构造释放，藉此，将最远部分235定向成便于组件400的导入用以部署装置100，这将结合图6A-C以及7在下文进行描述。进一步参见图4A和5，类似于套管220，套管420的内表面与外管230隔开径向间隙，该径向间隙例如在大约0.002英寸和大约0.01英寸之间。此外，根据一些较佳实施例，套管420的轴类似于铰接套管220的较佳实施例的上述轴进行构造，然后，远侧部段424可例如通过在大约100℃下热成型大约15分钟而成形为所期望的曲率；该曲率可通过在热成型过程中、将具有期望曲率的成形心轴插入到套管420的内腔内或者通过将套管420的远侧部段424限制在托盘的遵循期望曲率的沟槽内而赋予远侧部段424。
图5还示出了内部构件450的与装置100的近端121相适配的远端452，该装置容纳在外管230的最远部分235内。前文针对组件200描述的内部构件250的远端252的配合也可应用于组件400的内部构件450的远端452，从而外管230相对于套管420沿远侧方向的纵向运动类似地使得内部构件450运动；并且当外管230沿箭头R在相反的近侧方向上运动时，远端452会脱开，使得外管230的缩回独立于内部构件450。类似地，为了便于外管230相对于内部构件的运动，可在内部构件450和外管230之间的接合部处、以类似于上文针对系统组件200中内部构件250和外管230描述的方式将上述可生物相容的润滑剂和O形圈类型的密封构件用在系统组件400中。
图6A-C是示出根据一些实施例的处于各种导入状态的输送系统组件200/400的各部分的示意图。图6A示出了铰接套管220/420，该铰接套管通过拉线构件205(图2A和3)或者通过释放远侧部段424的预成形曲率(图4B)而偏转过角度θ，以将外管230的最远部分235定向成导入到患者的静脉系统中，这将在下文进行更详细地描述。偏转角度θ(从图4A的垂直线)可在从大约100度至大约200度的范围内。图6B示出了外管230，该外管230已沿箭头E相对于铰接套管220/240沿远侧方向从图6A的近侧位置运动至远侧位置，使得输送系统组件200/400相对于套管220/420延伸至到达用于部署装置100的目标植入部位，该装置容纳在外管230的最远部分235内(图3和5)。外管230相对于套管220/420的远端222/422的延伸部可在从大约5cm和大约10cm的范围内。如前所述，手柄210可用于沿箭头E相对于套管220/420在远侧方向上、连同内部构件250/450一起推动外管230，其中套管220/420的近端221/421和手柄210之间的前述距离(即，约10cm)允许外管230进行此种行进，而同时套管220/420仍保持就位。此外，在外管230行进时，较佳地通过例如手动地或经由可选的锁定构件245(图3)保持拉线构件205中的张力，来保持套管220的偏转。
图6C示出了以角度β的附加偏转，以在外管230的最远部分235图6B所示沿箭头E运动的过程之中或之后进一步定向该最远部分235；且根据一些实施例，可通过致动包括在内部构件250/450中的拉线构件来实现该附加偏转。上述相关的美国专利申请系列号13/239,990(代理案卷号P0040842.USU1)描述了一种可偏转的内部构件(220)，该内部构件包括拉线(225)并且适合于包含在系统组件200/400中的任一个内，且该申请的描述在此以参见的方式纳入本文；且手柄210的控制构件211(图2A和4A)可联接于拉线用于致动该拉线。一旦外管230的远端232定位在目标植入部位处，则外管230例如经由控制构件212的近侧运动而产生的缩回会露出装置100的固定构件115，以与例如上文暗指的该部位处的组织配合；且在上述相关美国专利申请系列号13/279,835(代理案卷号P0040169.USU1)中更详细地描述了在外管230缩回情形下装置100的部署，该申请的描述在此以参见的方式纳入本文。参见图3和5，控制构件212沿着手柄的最大行程x使得外管230沿箭头R在近侧方向上于大约10cm的距离上运动。
图7是包括一些示意图的流程图，该流程图概括了本发明的用于将系统组件200/400导入穿过患者的静脉系统以部署可植入医疗装置100的一些方法。根据初始步骤701并参见图3和5，将装置100加载到输送系统组件200/400的外管230的最远部分235中，使得整个装置100都容纳在最远部分235内并使得装置100的近端121邻抵于内部构件250/450的远端252/452。根据一些较佳实施例和方法，当根据步骤701加载装置100时，诸如在上述相关美国专利申请系列号13/279,835(代理案卷号P0040169.USU1)中描述的系绳之类的系绳附连于装置100的近端121。在加载了装置100之后，可通过经由手柄210中的端口265(图2A和4A)将流体(即，盐水)冲过外管230的内腔236、并且在系统组件400中冲过由内部构件450形成的内部内腔而从输送系统组件200/400中清除空气；然后，由于内腔内保持正流体压力，输送系统组件200/400例如通过股动脉部位处的引导套管而被引导到患者静脉系统中。随后，输送系统组件200可根据步骤703例如经由IVC(下腔静脉)行进到心脏的RA(右心房)中，在该位点处，如上所述较佳地通过使得铰接套管220/420偏转而根据步骤705来使得外管230的最远部分235朝向三尖瓣(TV)定向。返回参见图6A，偏转角度θ可以是大约110度，以使得最远部分235朝向TV定向。一旦定向好，则根据步骤707，外管230的最远部分235穿过TV行进到RV(右心室)中并行进至目标植入部位，使得最远部分235邻抵于该部位，且由外管230形成的内腔236在远端232处的远侧开口在该部位处位于诸如心肉柱之类的组织内。如上所述，在偏转的铰接轴220/420保持相对静止的同时，内部构件250/450的远端252/452的配合致使内部构件250/450的远端252/452和装置100连同行进的/延伸的最远部分235一起被载送，而例如在系统组件200的情形中，通过采用可选的锁定构件245(图3)或者通过例如利用夹子构件来固定拉线构件205的近侧控制端部215，使得偏转角θ保持相对恒定。返回参见图6C，在包括可偏转内部构件的那些实施例中，一些方法包括如下步骤：使内部构件以角度β偏转，以进一步定向最远部分235，从而使得远端232更精确地朝向目标植入部位。
在到达目标植入部位之后，最远部分235根据步骤709缩回，以露出装置100的固定构件115，用以使该固定构件与该部位处的组织配合。最远部分235的缩回可通过控制构件212的近侧运动来致动，如上所述，该控制构件联接于外管230的近端231。根据一些较佳的方法，最远部分235可在大约5cm和大约10cm的距离上缩回，用以部署装置100。根据替代的方法，内部构件250/450可相对于外管230行进，以朝远侧推动装置100，且藉此使得固定构件115露出于最远部分235外侧，然而，使得最远部分235根据步骤709而缩回是露出固定构件115以防止受伤的较佳方式，所述的受伤是例如由于过大推力而在目标植入部位处产生穿孔。在步骤709之后的部署装置100附加步骤在上述相关美国专利申请系列号13/279,835(代理案卷号P0040169.USU1)中进行了描述。
用于内部构件250/450和外管230的轴的构造可以是本领域已知的任何合适的类型，以实现满足这些轴所需操纵性的合适渐变柔性，该所需操作性包括可推性和扭矩传递以及上述偏转，用以如上所述导入到患者的静脉系统内。根据一示例实施例，内部构件250的轴在大约118cm的长度上延伸，从近端251延伸至刚好位于扩开远端252近侧，且该内部构件包括304医疗级别的不锈钢编织物，该不锈钢编织物夹在由7033形成的内衬垫和尼龙(Nylon)12形成的护套之间，所有这些都由外护套覆盖，其中外护套被分成：由尼龙12形成的近侧部段，该近侧部段大约是100cm长(包括在手柄210内延伸的那部分)；由5533形成的中间部段，该中间部段从近侧部段朝远侧在大约11cm的长度上延伸；以及由3533形成的远侧部段，该远侧部段从中间部段朝远侧在大约6.5cm的长度上延伸。根据内部构件250可偏转的那些实施例，外护套可包括拉线(即，0.009英寸直径的304不锈钢)在其中延伸的内腔，且拉线的远端可例如在内部构件250的轴的一部段中锚固在内部构件的扩开远端252附近，该拉线可由7233形成并在轴的前述远侧部段和远端252之间、例如延伸跨越大约0.5cm的长度。此外，根据示例实施例，外管230包括例如带有304医疗级别的不锈钢编织物(即，0.0018英寸×0.008英寸×45PPI)的6333的编织加强衬垫，该编织加强衬垫从近端231延伸至刚好位于最远部分235附近；轴的近侧部段覆盖有7033并且在大约92cm的长度(该长度的近侧部分总是容纳在手柄210内)上延伸：轴的中间部段覆盖有4033并且从近侧部段朝远侧在大约10cm的长度上延伸；而轴的远侧部段覆盖有3533并且从中间部段朝远侧在大约3cm的长度上延伸至刚好位于最远部分附近。外管230沿着上述部段的外直径和内直径可以分别是大约0.187英寸(约4.75mm)和大约0.154英寸(约3.91mm)。
前述的详细描述中，已经参考具体实施例描述了本发明。但是，可理解的是在不背离所附权利要求书所阐述的本发明的范围的情况下，可进行各种修改和改变。

Claims (15)

1.一种便于部署可植入医疗装置的输送系统组件，所述输送系统组件包括：
手柄，所述手柄包括至少一个控制构件；
细长的外管，所述外管从所述手柄朝远侧延伸并且形成内腔，所述内腔从所述内腔的位于所述外管的近端处的近侧开口延伸至所述内腔的位于所述外管的远端处的远侧开口，所述外管的近端联接于所述手柄的至少一个控制构件中的一个，且所述外管能经由所述控制构件相对于所述手柄纵向地运动，所述外管包括具有一定长度的最远部分，所述内腔沿着所述长度而尺寸被设计成将整个医疗装置容纳在其中，且所述内腔的所述远侧开口允许所述医疗装置穿过用以部署；
细长的内部构件，所述内部构件在所述外管的所述内腔内延伸，且所述内部构件包括近端和远端，所述远端构造成与所述可植入医疗装置的近端相适配，并且在如下位置处配合在所述外管的所述最远部分内，所述位置使得所述内部构件的经配合的远端和整个所述医疗装置能一起容纳在所述最远部分内；以及
铰接套管，所述铰接套管在所述手柄和所述外管的所述最远部分之间围绕所述外管，使得所述外管能在所述套管内纵向地运动，且所述套管包括近端、远端以及拉线构件，所述近端位于所述手柄的远侧，而所述拉线构件在所述套管的近端和远端之间延伸，且所述拉线构件包括近侧控制端部和远端，所述远端锚固在所述套管的远端附近用以使得所述套管偏转，而所述套管所具有的内直径小于所述外管的所述最远部分的外直径以及所述手柄的外直径；
其中，当所述内部构件的远端配合在所述外管的所述最远部分内时，所述外管相对于所述铰接套管沿远侧方向的纵向运动致使所述内部构件进行类似的纵向运动；以及
当所述外管相对于所述手柄沿近侧方向纵向地运动时，所述内部构件的远端在所述外管的所述最远部分内脱开，以使得所述外管的运动独立于所述内部构件。
2.如权利要求1所述的组件，其特征在于，所述铰接套管的长度在大约85cm和大约95cm之间。
3.如权利要求1所述的组件，其特征在于，所述手柄和所述外管的远端之间的最大距离在大约95cm和大约110cm之间。
4.如权利要求1所述的组件，其特征在于，当所述铰接套管的远端位于距所述外管的最远部分大约1cm之内时，所述铰接套管的近端位于从所述手柄向远侧大约10cm的距离处。
5.如权利要求1所述的组件，其特征在于，所述至少一个控制构件中的一个沿着所述手柄的最大行程使得所述外管沿所述近侧方向在大约
10cm的距离上运动。
6.如权利要求1所述的组件，其特征在于，所述铰接套管包括编织结构，所述编织结构夹在内聚合物衬垫和聚合物外护套之间，所述聚合物外护套分成近侧部段和远侧部段，且所述远侧部段所具有的硬度比所述近侧部段所具有的硬度低并且在大约3cm的长度上延伸。
7.如权利要求1所述的组件，其特征在于，所述内部构件还包括拉线，所述拉线在所述内部构件的近端和远端之间延伸，且所述内部构件的所述拉线的近端联接于所述至少一个控制构件的另一个，而所述拉线的远端锚固在所述内部构件的远端附近。
8.如权利要求1所述的组件，其特征在于，
所述外管还包括内肩部，所述内肩部限定所述外管的所述最远部分的近端；以及
所述内部构件的远端通过邻抵于所述内肩部而配合在所述外管的内腔内。
9.一种便于部署可植入医疗装置的输送系统组件，所述输送系统组件包括：
手柄，所述手柄包括至少一个控制构件；
细长的外管，所述外管从所述手柄朝远侧延伸并且形成内腔，所述内腔从所述内腔的位于所述外管的近端处的近侧开口延伸至所述内腔的位于所述外管的远端处的远侧开口，所述外管的近端联接于所述手柄的至少一个控制构件中的一个，且所述外管能经由所述控制构件相对于所述手柄纵向地运动，所述外管包括具有一定长度的最远部分，所述内腔沿着所述长度而尺寸被设计成将整个医疗装置容纳在其中，且所述内腔的所述远侧开口允许所述医疗装置穿过用以部署；
细长的内部构件，所述内部构件在所述外管的所述内腔内延伸并且形成内部内腔，所述内部内腔从其位于所述内部构件的近端处的近侧开口延伸至其位于所述内部构件的远端处的远侧开口，且所述内部构件的远端构造成与所述可植入医疗装置的近端相适配，并且在如下位置处配合在所述外管的所述最远部分内，所述位置允许所述内部构件的经配合的远端和整个医疗装置能一起容纳在所述最远部分内；
铰接套管，所述铰接套管在所述手柄和所述外管的最远部分之间围绕所述外管，使得所述外管能在所述套管内纵向地运动，且所述套管包括近端和远侧部段，所述近端位于所述手柄的远侧，而所述远侧部段具有预成形曲率，所述套管所具有的内直径小于所述最远部分的外直径以及所述手柄的外直径；以及
拉直心轴，所述拉直心轴构造成在所述内部构件的内部内腔内滑动，并且具有一定长度，所述长度足以在所述心轴完全插入到所述内部构件的内部内腔内时将所述铰接套管的远侧部段的预成形曲率拉直；
其中，当所述内部构件的远端配合在所述外管的所述最远部分内时，所述外管相对于所述铰接套管沿远侧方向的纵向运动致使所述内部构件进行类似的纵向运动；以及
当所述外管相对于所述手柄沿近侧方向纵向地运动时，所述内部构件的远端在所述外管的最远部分内脱开，以使得所述外管的运动独立于所述内部构件。
10.如权利要求9所述的组件，其特征在于，所述铰接套管的长度在大约85cm和大约95cm之间。
11.如权利要求9所述的组件，其特征在于，当所述外管处于所述近侧位置时，所述手柄和所述外管的远端之间的距离在大约95cm和大约110cm之间。
12.如权利要求9所述的组件，其特征在于，所述至少一个控制构件中的一个沿着所述手柄的最大行程使得所述外管沿所述近侧方向在大约10cm的距离上运动。
13.如权利要求9所述的组件，其特征在于，所述铰接套管包括编织结构，所述编织结构夹在内聚合物衬垫和聚合物外护套之间，所述聚合物外护套分成近侧部段和远侧部段，且所述远侧部段所具有的硬度比所述近侧部段所具有的硬度低并且在大约3cm的长度上延伸。
14.如权利要求9所述的组件，其特征在于，所述内部构件还包括拉线，所述拉线在所述内部构件的近端和远端之间延伸，且所述内部构件的拉线的近端联接于所述至少一个控制构件的另一个，而所述拉线的远端锚固在所述内部构件的远端附近。
15.如权利要求9所述的输送系统组件，其特征在于，
所述外管还包括内肩部，所述内肩部限定所述外管的所述最远部分的近端；以及
所述内部构件的远端通过邻抵于所述内肩部而配合在所述外管的内腔内。
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