CN103429296A - 递送导管系统和方法 - Google Patents
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Abstract
本发明提供了一种用于将无引线心脏起搏器植入到患者内的递送系统。心脏起搏器能够包括具有通孔的对接或者递送结构，其布置在起搏器的基端上或附近用于附接至递送系统。在一些实施例中，递送导管能够包括构造为接合起搏器递送结构的第一系绳和第二系绳。当部分对准时，系绳可以具有大于递送结构通孔的横截面直径；而当非对准时，系绳可以具有小于递送结构通孔的横截面直径。还提供了利用递送系统递送无引线心脏起搏器的方法。
Description
技术领域
本公开涉及无引线心脏起搏器，并且更具体地涉及将无引线心脏起搏器固定到心脏内的结构和方法。更具体地，本公开涉及用于将无引线心脏起搏器递送到组织的结构和方法。
背景技术
当心脏自身的天生起搏器和/或传导系统未能以足以让患者健康的速率和间隔提供同步的心房和心室收缩时，人工起搏器的心脏起搏对心脏提供电激励。这样抗心搏缓慢的起搏减轻了成千上万患者的症状甚至为他们提供了生命支持。心脏起搏还可以提供电过激激励，以抑制或转变快速性心率失常，从而再次提供症状缓解并且阻止或结束能够引起心脏性猝死的心律失常。
由目前可用的或传统的起搏器的心脏起搏通常由植入到皮下或肌肉下的脉冲发生器在患者胸部区域中或附近执行。脉冲发生器参数通常由体外的程序化装置来询问和变更，这通过带有位于体内的一个电感和位于体外的另一电感的松散耦合的互感器实现，或者通过带有位于体内的一个天线和位于体外的另一天线的电磁辐射实现。发生器通常连接到一个或者多个植入引线的基端，该引线的末端包含用于定位在心脏腔室的内壁或外壁附近的一个或者多个电极。引线具有一个或多个绝缘的导体用于将脉冲发生器连接到心脏中的电极。这种电极引线典型地具有50到70厘米的长度。
虽然每年植入十万以上的常规心脏起搏系统，但仍存在各种众所周知的困难，其中的一些将得以阐述。例如，当位于皮下时，脉冲发生器在皮肤中呈现一个患者觉得难看、令人不快或者恼人的凸起，并且患者会下意识地或者强迫地摆弄或者“玩弄”该凸起。即使没有持续摆弄，但皮下的脉冲发生器能够在引导线处出现腐蚀、挤压、感染以及断开、绝缘损坏或导体破损。虽然，肌肉下或者腹部布置能够解决一些关注，但这种布置涉及用于植入和调整的更困难的外科手术，这会延长患者的恢复。
不管是胸部的或腹部的常规脉冲发生器均具有用于与传送信号到心脏及从心脏接收信号的电极引线相连或断开的接口。通常至少一个凸形连接器模制件（male connector molding）具有在电极引线基端处的至少一个端子引脚。凸形连接器匹配脉冲发生器处的相应凹形连接器模制件以及连接器模制件内的端子部分。通常调节螺钉被螺旋紧固到每一电极引线的至少一个端子部分中以确保电气和机械的连接。通常还提供一个或多个O形圈，以帮助维持连接器模制件之间的电隔离。通常包括调节螺钉帽或带狭槽的盖以提供调节螺钉的电绝缘。该简要说明的、连接器和引线之间的复杂连接提供了发生故障的诸多机会。
常规起搏器中的其它问题方面涉及分开植入的脉冲发生器和起搏引线。再举一例，特别是起搏引线能够成为感染和发病的场所。如文中相关申请中所描述的，与常规起搏器相关的许多问题通过研发自给式和自可持续的起搏器或所谓的无引线起搏器来解决。
自给式或无引线的起搏器或者其它的生物激励器通常通过主动接合机构如旋拧到心肌层中的螺钉或者螺旋状构件而固定到心脏内的植入部位。
发明内容
在一个实施例中，提供了一种用于植入医疗装置的递送导管，其包括：把柄；联接到把柄的导管轴；布置在导管轴内并向末端延伸超出导管轴的第一系绳，该第一系绳包括定位在第一系绳的末端部附近的第一锁定结构；布置在导管轴内并向末端延伸超出导管轴的第二系绳，该第二系绳包括定位在第二系绳的末端部附近的第二锁定结构；联接到第一系绳的系绳调节结构，该系绳调节结构被构造为调整第一系绳的向末端延伸超出导管轴的长度。
在一些实施例中，递送导管包括：对准构造，其中第一锁定结构和第二锁定结构至少部分地并排定位；和非对准构造，其中第一锁定结构和第二锁定结构不并排定位。
在一些实施例中，系绳调节结构便于使递送导管在对准构造和非对准构造之间转换。
在一个实施例中，递送导管还包括布置在导管轴的末端部上的对接帽和布置在导管轴内的扭转轴，该扭转轴联接到对接帽，扭转轴被构造为将旋转转矩施加到对接帽以旋转对接帽。
在另一实施例中，递送导管还包括布置在导管轴上的保护套，该保护套可沿导管轴滑动并包括沿着保护套纵向延伸的折痕（crease），其中保护套被构造为沿折痕将自身折叠起来，以减少保护套的递送直径。
还提供了一种无引线起搏器和递送系统，其包括无引线心脏起搏器和递送导管，该无引线心脏起搏器包括布置在起搏器的基端部上的附接结构，该附接结构包括具有第一直径的通孔，该递送导管包括：把柄；联接到把柄的导管轴；布置在导管轴内并向末端延伸超出导管轴的第一系绳，该第一系绳包括定位在第一系绳的末端部附近的第一锁定结构；布置在导管轴内并向末端延伸超出导管轴的第二系绳，该第二系绳包括定位在第二系绳的末端部附近的第二锁定结构；和联接到第一系绳的系绳调节结构，该系绳调节结构被构造为调整第一锁定结构相对于第二锁定结构的位置，所述递送导管包括对准构造，其中第一锁定结构的一部分与第二锁定结构的一部分沿纵向对准，并且包括比通孔的第一直径更大的组合横截面直径，所述递送导管还包括非对准构造，其中第一锁定结构与第二锁定结构沿纵向不对准，并且包括比通孔的第一直径更小的组合横截面直径。
在一些实施例中，系绳调节结构便于使递送导管在对准构造和非对准构造之间转换。
在另一实施例中，递送导管还能够包括布置在导管轴的末端部上的对接帽和布置在导管轴内的扭转轴，该扭转轴联接到对接帽，扭转轴被构造为将旋转转矩施加到对接帽以旋转对接帽。
在一个实施例中，递送导管还能够包括布置在导管轴上的保护套，该保护套可沿导管轴滑动并包括沿着保护套纵向延伸的折痕，其中保护套被构造为沿折痕将自身折叠起来，以减少保护套的递送直径。
还提供了一种利用递送导管将医疗装置递送至患者的方法，其包括：将医疗装置的附接结构定位成接近递送导管的附接机构；将递送导管的附接机构沿末端方向插入通过医疗装置的附接结构中的孔，该附接机构具有比所述孔的直径更小的横截面直径；增加附接机构的横截面直径，以防止附接机构通过医疗装置的附接结构的孔沿基端方向往回移动。
在一些实施例中，附接结构包括布置在递送导管内并且向末端延伸超出递送导管的一对系绳，每个系绳均具有锁定结构。
在一个实施例中，当系绳的锁定结构的各部分沿纵向不对准时，附接结构具有比所述孔的直径更小的横截面直径。
在另一实施例中，增加横截面直径的步骤包括：沿纵向对准系绳的锁定结构的至少一部分。
在一些实施例中，所述医疗装置包括无引线心脏起搏器。
在一个实施例中，所述方法包括：利用附接机构将医疗装置向基端拉动，以将医疗装置设置成接触递送导管的末端。
在另一实施例中，所述方法还包括：将医疗装置和递送导管插入到患者内邻近植入部位；以及将旋转转矩从递送导管施加到医疗装置，以将医疗装置的固定器件旋拧到植入部位中。
提供了另一种利用递送导管将无引线起搏器递送至患者的方法，其包括：将递送导管的第一系绳的第一锁定结构定位在与递送导管的第二系绳的第二锁定结构不同的纵向位置处，使得锁定结构的组合横截面直径小于无引线起搏器的附接结构中的孔的横截面直径；通过所述孔将第一锁定结构和第二锁定结构插入于无引线起搏器的附接结构中；以及在同一纵向位置处将第一锁定结构的一部分与第二锁定结构的一部分对准，使得锁定结构和系绳的组合横截面直径大于无引线起搏器的附接机构中的孔的横截面直径。
在一些实施例中，所述方法还包括：利用第一系绳和第二系绳将医疗装置向基端拉动，以将无引线起搏器设置成接触递送导管的末端。
在另一实施例中，所述方法还包括：将医疗装置和递送导管插入到患者内邻近植入部位；以及将旋转转矩从递送导管施加到无引线起搏器，以将起搏器的固定器件旋拧到植入部位中。
附图说明
本发明新颖特征在随后的权利要求中具体阐述。参考下面阐述了示意性实施例的详细描述和附图将得到对于本发明的特征和优点的更好理解，其中示意性实施例利用了本发明的原理，在附图中：
图1示出了用于递送无引线起搏器的递送系统的一个实施例。
图2A-2B是递送系统末端部的近景图。
图3A-3B是起搏器套管的示意性侧视图和横截面图。
图4A-4G是附接至起搏器的递送系统的侧视图。
图5A-5D是导管把柄和系绳键（tether key）的各种视图。
图6A-6B是具有单个系绳的递送系统的替代实施例。
具体实施方式
描述了包括一个或多个无引线心脏起搏器或生物激励器的递送系统的各种实施方式。无引线心脏起搏器能够通过传导通信进行通信，表现出了与常规起搏系统的明显不同。例如，示意性的心脏起搏系统能够执行心脏起搏，其具有常规心脏起搏器的许多优点，同时通过若干个改进中的一个或多个扩展了性能、功能性和操作特性。
在心脏起搏系统的一些实施方式中，心脏起搏的提供方式没有位于胸部区域或者腹部中的脉冲发生器、没有和脉冲发生器分开的电极引线、没有通信线圈或天线并且没有对用于传输通信的电池电力的额外需求。
构造成实现这些特性的心脏起搏系统的实施例包括无引线心脏起搏器，其大致包封在适于布置或附接到心脏腔室的内侧或外侧的密封壳体中。该起搏器能够具有位于壳体内、壳体上或者壳体附近的两个或者更多个电极，用于将起搏脉冲递送到心脏腔室的肌肉并且可选地用于感测肌肉的电活动，并且用于与身体内侧或外侧的至少一个其它装置双向通信。壳体能够包含主电池，以提供用于起搏、感测和通信例如双向通信的电力。壳体能够选择性地包含用于从电极感测心脏活动的电路。壳体包含用于经由电极从至少一个其它装置接收信息的电路，并且包含用于产生经由电极递送的起搏脉冲的电路。壳体能够可选地包含用于将信息经过电极传输到至少一个其它装置的电路，并且能够可选地包含用于监测装置工作状态的电路。壳体包含用于以预定方式控制这些操作的电路。
在一些实施例中，心脏起搏器能够适于递送和植入到人体的组织中。在具体实施例中，无引线心脏起搏器能够适于使用位于起搏器的壳体上或内部的两个或更多个电极而植入到在心脏腔室的内壁或者外壁上的心脏组织附近，用于在接收到来自体内的至少一个其它装置的触发信号时起搏心脏腔室。
自给式或者无引线的起搏器或者其它的生物激励器通常通过主动接合机构或主固定机构诸如旋拧到心肌层中的螺钉或者螺旋状构件而固定到心脏内植入部位。这种无引线生物激励器的示例在以下公布中记载，以下公布的公开通过参考合并于此：（1）在2006年10月13日提交的标题为“结合可植入复律除颤器使用的无引线心脏起搏器系统（Leadless CardiacPacemaker System for Usage in Combination with an Implantable Cardioverter-Defibrillator）”的第11/549,599号并在2007年4月19日公布为US2007/0088394Al的美国申请；（2）在2006年10月13日提交的标题为“无引线心脏起搏器（Leadless Cardiac Pacemaker）”的第11/549,581号并在2007年4月19日公布为US2007/0088396A1的美国申请；（3）在2006年10月13日提交的标题为“具有传导通信的无引线心脏起搏器系统（Leadless CardiacPacemaker System with Conductive Communication）”的第11/549,591号并在2007年4月19日公布为US2007/0088397A1的美国申请；（4）在2006年10月13日提交的标题为“由传导通信触发的无引线心脏起搏器（LeadlessCardiac Pacemaker Triggered by Conductive Communication）”的第11/549,596号并在2007年4月19日公布为US2007/0088398A1的美国申请；（5）在2006年10月13日提交的标题为“速率响应性无引线心脏起搏器（Rate ResponsiveLeadless Cardiac Pacemaker）”的第11/549,603号并在2007年4月19日公布为US2007/0088400A1的美国申请；（6）在2006年10月13日提交的标题为“用于生物激励器系统的程序器（Programmer for Biostimulator System）”的第11/549,605号并在2007年4月19日公布为US2007/0088405A1的美国申请；（7）在2006年10月13日提交的标题为“用于可植入生物激励器的递送系统（Delivery System for Implantable Biostimulator）”的第11/549,574号并在2007年4月19日公布为US2007/0088418A1的美国申请；和（8）在2006年10月13日提交的标题为“无引线心脏起搏器和系统（LeadlessCardiac Pacemaker and System）”的第PCT/US2006/040564号并在2007年4月26日公布为WO07047681A2的国际申请。
在诸如螺旋线的主固定机构之外，一些生物激励器还能够包括辅助固定机构，以提供用于将生物激励器在体内保持到位的另一结构。辅助固定机构能够是主动的（例如，辅助固定机构能够在心脏内或外主动接合组织），或者能够是被动的（例如，辅助固定机构并不附接至组织，而是阻止生物激励器在不慎脱离情况下在身体内到处移动）。关于辅助固定机构的更多细节可见第12/698,969号美国申请。
无引线起搏器或生物激励器能够使用在本文描述的任一递送系统递送至患者以及从患者回收。在一些实施例中，生物激励器附接至或连接到递送系统并静脉式地行进到心脏中。递送系统能够包括接合生物激励器的结构，以允许生物激励器到组织的固定。例如，在生物激励器包括如螺钉或螺旋构件等主动接合机构的实施例中，递送系统能够包括对接帽或键，其构造为接合生物激励器并施加转矩，以将主动接合机构旋拧到组织中。在其它实施例中，递送系统包括夹子，其设计为匹配生物激励器上的结构形状并施加转矩，以将主动接合机构旋拧到组织中。
图1示出了起搏器递送系统100，其构造为将无引线起搏器102递送到患者内。递送系统100能够包括起搏器套管104、导向件导管轴111、起搏器引导器套管107、把柄108、偏转钮110、系绳梭子（tether shuttle）112和冲洗口114a、114b和114c。偏转钮110能够用于在植入和/或移除起搏器期间调向和引导导管。冲洗口114a、114b和114c能够用于冲洗生理盐水或其它流体通过导管。套管107可以向末端行进越过导管轴111，以在植入期间为递送导管提供额外的调向和支持，并且在起搏器通过套管针或引导器导入患者内时包围住起搏器。
图2A是递送系统200的末端部和起搏器202的近景图。图2A中的起搏器可以包括用于将起搏器附接至组织的螺旋结构203。在图2A中，起搏器附接至导管轴206的对接帽218。起搏器套管204示出为沿着导管轴206向基端拉回并引导导管轴211，以露出起搏器202和螺旋结构203。在图2B中，起搏器套管204沿着导向件导管轴211向末端延伸以盖住导管轴206、起搏器202和螺旋结构，以在植入期间保护组织免受螺旋结构锋利的边缘伤害。如图2A所示，当起搏器套管向基端回拉时，起搏器202处于暴露的递送构造中。如图2B所示，当起搏器套管向末端行进以保护起搏器和螺旋结构时，起搏器202处于受保护的行进构造中。
图3A-3B是递送系统300的起搏器套管304的近景图和横截面视图。如示出的，起搏器304可以包括沿套管长度的折痕或折叠部320。在初次将递送系统插入患者内时，医师可以采用Seldinger技术使用引导器套管接触患者静脉系统（未示出）。然后，包括无引线起搏器和导管轴的递送系统可以通过引导器套管行进到患者的静脉系统中，以方便递送起搏器进入心脏。减少起搏器、递送系统的直径并由此减少引导器套管的直径会更加简单地且侵扰程度更低地接触患者静脉系统。
通过用沿着套管纵向延伸的折叠部320来设计起搏器套管304，起搏器套管的横截面直径能够通过将套管自身折叠起来而减少。由此，在通过引导器套管将起搏器初次植入到患者中期间，起搏器套管可以正好靠近起搏器定位，并沿着折叠部320折叠以具有接近或等于起搏器直径的横截面直径。由于那些递送系统必须结合更大的引导器套管以允许全尺寸的起搏器套管通过，这就允许使用比通常必要的更小直径的引导器套管。在递送系统通过引导器套管插入患者内后，套管可以越过无引线起搏器向末端行进。起搏器套管向末端行进会导致折叠部320展开，从而增加起搏器套管的直径，使得它能够滑过并覆盖起搏器和固定螺旋结构。图3B是起搏器螺旋结构304和折叠部320的横截面图，其给出了起搏器套管横截面直径怎样增加和减少的另一个视图。
图4A示意了递送系统400，其包括包含了螺旋结构403和附接结构424的起搏器402以及递送导管，递送导管包含了起搏器套管404、导管轴406、对接帽418及系绳422a和422b。系绳能够包括线材、轴、管、绳、绳索、线或者其它可以延伸贯穿导管轴的类似结构。在一些实施例中，系绳包括形状记忆材料，例如镍钛诺（nitinol）。在其它的实施例中，系绳包括不锈钢线材或编带。在图4A中，起搏器402没有附接至递送导管的对接帽418。现在将会描述将起搏器连接到递送导管的过程。
参考图4B，系绳422a和422b能够包括末端结构426a和426b。末端结构可以例如是在系绳上并从系绳沿径向突出的结构，如凸块、球、圆柱、矩形体或者从系绳向外延伸的其它类似形状。在一些实施例中，末端结构能够是可扩展的，如气球或可扩展的机械结构。一般地，末端结构具有的横截面直径大于系绳的横截面直径。如在一个实施例中示出的，末端结构422a可以比末端结构422b行进的更远，使得当系绳被一起推动时，末端结构422b抵靠在系绳422a上。这导致末端结构和系绳两者的组合横截面直径比末端结构并排着排列时要更小。通过比较，图4C中，末端结构426a和426b并排排列，因此当压在一起时具有比图4B所示更大的组合横截面直径。
为了将递送导管连接到起搏器，可以调整系绳422a和422b的长度以及由此形成的末端结构426a和426b的位置，使得末端结构426a和426b在并排构造（例如，图4A-4B展示的非对准构造）中不对准。当系绳和末端结构为这种非对准构造时，由于末端结构没有并排定位，末端结构的横截面直径减少。然后，如图4D-4F所示，系绳末端结构426a和426b可以在这种非对准的构造下行进通过附接结构424的孔428。在这个实施例中，孔428的直径必须足够大，以允许系绳422a和422b的末端结构426a和426b在处于非对准的构造下时通过。一旦末端结构穿过孔428，然后就可以调整系绳的长度，以在并排的构造中对准末端结构（例如，如图4C和4E中示出的）。当末端结构并排定位时，末端结构的组合横截面直径变得大于孔428的直径，这基本上将系绳和末端结构锁定在附接结构424中，阻止末端结构能够向基端穿过孔428。
仍参照图4C和图4D，递送导管的对接帽418可以包括扭转狭槽430（图4C示出），其尺寸和构造匹配布置在起搏器基端的扭转键432（图4D示出）。扭转狭槽430可以联接到扭转轴431，扭转轴431沿着延伸到把柄中的递送导管的长度（未示出）。在图4C和4D中，扭转键430展示为“凸形”键，扭转狭槽430展示为“凹形”键，但应该理解，在其它的实施例中，“凸形”键可以定位在附接结构418上，“凹形”键可以布置在起搏器上。还应该理解的是，键432和狭槽430可以包括任意数量的形状，例如方形、矩形、三角形、五边形、六边形、十字形、“X”形等等，只要键432装配在狭槽430内并且能够施加旋转转矩到狭槽430。一旦系绳锁定在附接结构内，系绳可以向基端拉动，以朝着导管拉动附接结构424和起搏器并将起搏器附接至递送导管，从而将扭转狭槽430与扭转键432接合（如图4G所示）。
图5A-5D是递送系统500的把柄508的近景图。在图5A中，把柄508包括偏转钮510、系绳钮512、系绳调节结构514和冲洗口516。如前面描述的，偏转钮510在起搏器植入和/或移除期间提供对导管的调向和引导。冲洗口516可以用来冲洗生理盐水或其它流体通过导管。现在参考图5B和5C，系绳调节结构514能够被构造为然后调节系绳522a和522b的从递送导管向末端朝外延伸的长度，导致末端结构（未示出）要么处于并排的“锁定”构造要么处于未对准的“解锁”构造。
系绳调节结构能够包括内六角扳手或任何其它合适的键，并且可以被构造为分别与布置在梭子512内的系绳522a及522b的基端键534a及534b匹配且接合。在其它的实施例中，系绳调节结构可以包括把柄自身上的钮或转盘，并且用户能够简单地转动钮或转盘来调节系绳的长度。如图5D所示，梭子可以插入到把柄508内。在图5C中示出了系绳522a和522b的基端键534a和534b，为了图解的方便，没有示出梭子536。系绳调节结构514的旋转导致基端键534a和/或534b在梭子512内向末端或基端移动，这因此改变系绳522a和/或522b的从递送导管向末端延伸的长度。由此，系绳键能够用于对准系绳末端结构使其处于并排（例如，锁定）构造，或者替代地设置系绳末端结构使其处于非对准（例如，解锁）构造，以允许起搏器对接和锁定到递送导管。
返回参考图4D-4G和图5A，现在可以理解在本文描述的起搏器怎样能够被递送和附接至组织，然后怎样能够从递送系统释放。在图4D-4F中，系绳422a和422b可以在“解锁”或未对准的构造下插入到附接结构424的孔428中。然后，系绳的末端结构能够对准，以将末端结构锁定在附接结构中。参考图5A，系绳梭子512然后可以向基端拉动，导致系绳向基端移动，从而将起搏器对接到递送导管上（如图4G所示）。当起搏器对接到递送导管上时，起搏器的扭转键432（示于图4G）装配并嵌合到递送导管的扭转狭槽420（示于图4C）。
参考图5A，把柄508的系绳梭子512然后能够被转动，这会转动递送导管内的扭转轴431（示于图4C），并施加转矩到扭转狭槽430，并由此施加到起搏器上的扭转键432。通过旋转梭子并由此旋转扭转轴，递送导管施加转矩到起搏器，以将起搏器的固定螺旋结构旋拧到组织内。一旦固定螺旋结构完全插入到组织内，则系绳可以由系绳调节结构514设置进入非对准或“解锁”的构造，允许系绳和末端结构从起搏器附接结构移除。一旦递送导管从起搏器脱离，导管就可以从患者移除，将起搏器留在目标组织的适当位置。
图6A和6B示出了用于将递送导管附接至起搏器的替代实施例。示出在图6A和6B中的该实施例采用了与上面描述类似的概念。但是，代替使用如上面描述的两个系绳，图6A和6B的实施例利用单一的系绳622，其具有末端结构626a和基端结构626b两者。在图6A和6B的实施例中，系绳622可以包括形状记忆合金，如镍钛诺；并可以包括预弯曲或预偏置的形状。如图6A所示，这种预偏置的形状能够允许系绳的末端结构626a天然地向外偏置。
如图6A所示，为了将起搏器602附接至递送导管，系绳622的末端结构626a可以以螺旋方式穿过起搏器602的附接结构624。一旦系绳以螺旋方式穿过附接结构，系绳就可以对着自身折叠回来，使得末端结构626a会邻近基端结构626b，但不会直接在其旁边。如上面两系绳实施例中描述的，末端和基端结构应该在非对准或“解锁”的构造下进行对准。如图6B所示，这种构造允许末端和基端结构插入到对接帽618的孔628中。一旦末端和基端结构行进通过孔628，则导管内的内部腔室（未示出）打开，直到直径大于孔628的直径为止。这个内部腔室具有足够大的直径来容纳处于并排或“锁定”构造的末端和基端结构两者。由此，系绳的长度可以调整，以在并排的构造下对准末端和基端结构，导致末端和基端结构的组合横截面直径大于孔628的直径。这导致系绳622锁定在递送导管内。
图6A-6B的实施例的其它特征可以与上面描述的相同，例如扭转键、狭槽和轴，其允许递送导管施加旋转转矩到起搏器，以将其旋拧到组织中。
至于与本发明相关的其它细节，在本领域技术人员的水平范围内，可以采用相应材料和制造技术。就通常或者常规采用的其它动作而言，以上同样适用于本发明的基于方法的方面。另外，应设想，所述发明性变化的任意可选特征可以独立地阐述和要求，或者与本文所述的任一或多个特征组合。同样，参考单一项，包括存在多个同一项的可能性。更具体地，如本文以及在所附权利要求中使用的，除非在上下文中明显指出，单数形式“一”、“和”、“所述”和“该”包括多个引用。进一步注意到，权利要求可起草为排除任何可选元件。照此，该声明旨在用作与所要求的元件的记载结合使用这种独占性术语如“只”、“仅”等等、或者使用“反面”限制的先行基础。除非本文另外限定，本文使用的全部的技术和科学术语的含义与本本发明所属领域的普通技术人员所通常理解的含义相同。本发明的范围不局限于主题说明，而是仅由采用的权利要求术语的普通含义限定。
相关申请的交叉引用
本申请要求2010年12月13日提交的标题为“递送导管系统和方法（Delivery Catheter Systems and Methods）”的美国临时专利申请61/422,620的优先权，该申请的全部内容通过引用合并于此。
合并参考
本说明书中提及的全部公开和专利申请在同一程度上通过引用合并于此，如同每个单独的公开或者专利申请被具体地并且单独地专用于通过引用进行合并。
Claims (19)
1.一种用于植入医疗装置的递送导管，包括：
把柄；
联接到所述把柄的导管轴；
第一系绳，所述第一系绳布置在所述导管轴内并且向末端延伸超出所述导管轴，所述第一系绳包括定位在所述第一系绳的末端部附近的第一锁定结构；
第二系绳，所述第二系绳布置在所述导管轴内并且向末端延伸超出所述导管轴，所述第二系绳包括定位在所述第二系绳的末端部附近的第二锁定结构；
联接到所述第一系绳的系绳调节结构，所述系绳调节结构被构造为调整第一系绳的向末端延伸超出所述导管轴的长度。
2.根据权利要求1所述的递送导管，其中，所述递送导管包括：对准构造，其中所述第一锁定结构和第二锁定结构至少部分地并排定位；和非对准构造，其中所述第一锁定结构和第二锁定结构并不并排定位。
3.根据权利要求2所述的递送导管，其中，所述系绳调节结构便于使所述递送导管在所述对准构造和所述非对准构造之间转换。
4.根据权利要求1所述的递送导管，还包括：
布置在所述导管轴的末端部上的对接帽；和
布置在所述导管轴内的扭转轴，所述扭转轴联接到所述对接帽，所述扭转轴被构造为将旋转转矩施加到所述对接帽以旋转所述对接帽。
5.根据权利要求1所述的递送导管，还包括布置在所述导管轴上的保护套，所述保护套可沿所述导管轴滑动并包括沿着所述保护套纵向延伸的折痕，其中所述保护套被构造为沿折痕将自身折叠起来，以减少所述保护套的递送直径。
6.一种无引线起搏器和递送系统，包括：
无引线心脏起搏器，所述无引线心脏起搏器包括布置在所述起搏器的基端部上的附接结构，所述附接结构包括具有第一直径的通孔；和
递送导管，所述递送导管包括：
把柄；
联接到所述把柄的导管轴；
第一系绳，所述第一系绳布置在所述导管轴内并且向末端延伸超出所述导管轴，所述第一系绳包括定位在所述第一系绳的末端部附近的第一锁定结构；
第二系绳，所述第二系绳布置在所述导管轴内并且向末端延伸超出所述导管轴，所述第二系绳包括定位在所述第二系绳的末端部附近的第二锁定结构；和
联接到所述第一系绳的系绳调节结构，所述系绳调节结构被构造为调整所述第一锁定结构相对于所述第二锁定结构的位置；
所述递送导管包括对准构造，其中所述第一锁定结构的一部分与所述第二锁定结构的一部分沿纵向对准，并且包括比所述通孔的第一直径更大的组合横截面直径，所述递送导管还包括非对准构造，其中所述第一锁定结构与所述第二锁定结构沿纵向不对准，并且包括比所述通孔的第一直径更小的组合横截面直径。
7.根据权利要求6所述的递送导管，其中，所述系绳调节结构便于使所述递送导管在所述对准构造和所述非对准构造之间转换。
8.根据权利要求6所述的递送导管，还包括：
布置在所述导管轴的末端部上的对接帽；和
布置在所述导管轴内的扭转轴，所述扭转轴联接到所述对接帽，所述扭转轴被构造为将旋转转矩施加到所述对接帽以旋转所述对接帽。
9.根据权利要求6所述的递送导管，还包括布置在所述导管轴上的保护套，所述保护套可沿所述导管轴滑动并包括沿着所述保护套纵向延伸的折痕，其中所述保护套被构造为沿折痕将自身折叠起来，以减少所述保护套的递送直径。
10.一种利用递送导管将医疗装置递送至患者的方法，包括：
将所述医疗装置的附接结构定位成接近所述递送导管的附接机构；
将所述递送导管的附接机构沿末端方向插入通过所述医疗装置的附接结构中的孔，所述附接机构具有比所述孔的直径更小的横截面直径；
增加所述附接机构的横截面直径，以防止所述附接机构通过所述医疗装置的附接结构的孔沿基端方向往回移动。
11.根据权利要求10所述的方法，其中，所述附接结构包括布置在所述递送导管内并且向末端延伸超出所述递送导管的一对系绳，每个系绳均具有锁定结构。
12.根据权利要求11所述的方法，其中，当所述系绳的锁定结构的各部分沿纵向不对准时，所述附接结构具有比所述孔的直径更小的横截面直径。
13.根据权利要求11所述的方法，其中，增加横截面直径的步骤包括：沿纵向对准所述系绳的锁定结构的至少一部分。
14.根据权利要求10所述的方法，其中，所述医疗装置包括无引线心脏起搏器。
15.根据权利要求10所述的方法，还包括：利用所述附接机构将所述医疗装置向基端拉动，以将所述医疗装置设置成接触所述递送导管的末端。
16.根据权利要求15所述的方法，还包括：将所述医疗装置和所述递送导管插入到患者内邻近植入部位；以及将旋转转矩从所述递送导管施加到所述医疗装置，以将所述医疗装置的固定器件旋拧到植入部位中。
17.一种利用递送导管将无引线起搏器递送至患者的方法，包括：
将所述递送导管的第一系绳的第一锁定结构定位在与所述递送导管的第二系绳的第二锁定结构不同的纵向位置处，使得所述锁定结构的组合横截面直径小于所述无引线起搏器的附接机构中的孔的横截面直径；
通过所述孔将所述第一锁定结构和第二锁定结构插入于所述无引线起搏器的附接结构中；以及
在同一纵向位置处将所述第一锁定结构的一部分与所述第二锁定结构的一部分对准，使得所述锁定结构和系绳的组合横截面直径大于所述无引线起搏器的附接机构中的孔的横截面直径。
18.根据权利要求17所述的方法，还包括：利用所述第一系绳和第二系绳将所述医疗装置向基端拉动，以将所述无引线起搏器设置成接触所述递送导管的末端。
19.根据权利要求18所述的方法，还包括：将所述医疗装置和所述递送导管插入到患者内邻近植入部位；以及将旋转转矩从所述递送导管施加到所述无引线起搏器，以将所述起搏器的固定器件旋拧到植入部位中。
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Also Published As
| Publication number | Publication date |
|---|---|
| US20140074114A1 (en) | 2014-03-13 |
| US20120197373A1 (en) | 2012-08-02 |
| US20150112361A1 (en) | 2015-04-23 |
| US8615310B2 (en) | 2013-12-24 |
| US9205225B2 (en) | 2015-12-08 |
| EP2651494A4 (en) | 2014-05-28 |
| JP2014501136A (ja) | 2014-01-20 |
| WO2012082735A1 (en) | 2012-06-21 |
| EP2651494B1 (en) | 2017-02-15 |
| US8958892B2 (en) | 2015-02-17 |
| EP2651494A1 (en) | 2013-10-23 |
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