CN103402578B - 起搏器回收系统和方法 - Google Patents

起搏器回收系统和方法 Download PDF

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CN103402578B
CN103402578B CN201180067415.5A CN201180067415A CN103402578B CN 103402578 B CN103402578 B CN 103402578B CN 201180067415 A CN201180067415 A CN 201180067415A CN 103402578 B CN103402578 B CN 103402578B
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conduit
snare
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CN103402578A (zh
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A.卡尔卡汉
A.克伦克
T.伊比
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St Jude Medical LLC
Pacesetter Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • 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
    • A61N1/0587—Epicardial electrode systems; Endocardial electrodes piercing the pericardium
    • A61N1/059—Anchoring means
    • 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
    • A61N1/372—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
    • 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
    • A61N1/372—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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/32056—Surgical snare instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00358—Snares for grasping
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
    • A61B2017/22035—Gripping instruments, e.g. forceps, for removing or smashing calculi for retrieving or repositioning foreign objects
    • 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
    • A61M25/0082—Catheter tip comprising a tool
    • 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
    • A61N1/0573—Anchoring means; Means for fixing the head inside the heart chacterised by means penetrating the heart tissue, e.g. helix needle or hook
    • 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

本发明提供了一种用于从患者回收无引线心脏起搏器的导管系统。心脏起搏器能够包括构造成由导管系统抓住的对接或者回收结构。在一些实施方式中，回收导管能够包括圈套器，所述圈套器构造成接合起搏器的回收结构。回收导管能够包括扭转轴，所述扭转轴能够有选择地连接到对接帽，并且构造成将旋转转矩施加到要回收的起搏器。另外提供了用递送系统递送无引线心脏起搏器的方法。

Description

起搏器回收系统和方法
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从心脏除去的结构和方法。更具体地，本公开涉及用于从组织回收无引线心脏起搏器的结构和方法。
背景技术
当心脏本身的自然起搏器和/或传导系统未能以符合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。这样的防心动起搏过缓减轻了成百上千患者的症状并且甚至提供了生命支持。心脏起搏还可以提供电过激激励，以抑制或者转变快速性心律失常，从而再次提供了症状减轻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进行的心脏起搏通常由皮下地或者肌肉下地植入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并修改，这经由带有位于体内的一个电感和位于体外的另一电感的松散联接的互感器实现，或者经由带有位于体内的一个天线和位于体外的另一天线的电磁幅射实现。该发生器通常连接到一个或者多个植入的引线的基端，该引线的末端包含一个或者多个电极，该一个或者多个电极定位在心脏腔室的内壁或外壁附近。引线具有用于将脉冲发生器连接到心脏中的电极的被绝缘的一个或多个电导体。这种电极引线典型地具有50至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，但仍存在众所周知的各种困难，将阐述其中的若干困难。例如，当位于皮下时，脉冲发生器在皮肤中呈现凸出部分，使得患者难看、不愉快或者使愤怒，并且患者会下意识地或者强迫性地操作或“捻弄”该凸出部分。即使未持续操作，皮下的脉冲发生器能够在引导线处呈现出腐蚀、压挤、感染以及断开、绝缘损坏或者导体破损。虽然，肌肉下或者腹部布置能够解决一些关注的问题，但这种布置涉及用于植入和调整的更困难的外科程序，这会延长患者的痊愈。
不管是胸部的还是腹部的常规脉冲发生器均具有用于与传送信号到心脏以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（maleconnectormolding）具有位于电极引线的基端处的至少一个端子引脚。该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。通常地，调节螺钉被旋拧到每一电极引线的至少一个端子部分中，以在电气和机械方面固定连接。通常还提供一个或者多个O形环，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。该简要说明的在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有问题方面涉及脉冲发生器和起搏引线的分开植入。再举一例，起搏引线具体地能够成为感染和病状的场所。如文中相关申请中所描述的，与常规起搏器关联的许多问题通过研发自给式和自可持续的（self-containedandself-sustainable）起搏器或者所谓的无引线起搏器来解决。
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。
发明内容
提供了一种用于从患者回收医疗装置的导管，包括：把柄；导管轴，所述导管轴联接到所述把柄；圈套器（snare），所述圈套器布置在所述导管轴内，并且能够在末端方向上延伸超过所述导管轴；对接帽，所述对接帽布置在所述导管轴的末端部上，所述对接帽能够独立于所述导管轴旋转；和扭转轴，所述扭转轴布置在所述导管轴内，并且能够选择性地连接到所述对接帽，所述扭转轴构造成在连接到所述对接帽时在所述导管轴内旋转，以将旋转转矩施加到所述对接帽。
在一些实施方式中，导管还包括布置在所述对接帽的内表面上的干涉结构，所述干涉结构构造成与要回收的医疗装置上的相应的干涉结构接合。在一些实施方式中，干涉结构包括脊（ridge）。
在一些实施方式中，导管还包括布置在所述对接帽内侧的狭槽，所述狭槽构造成接合所述扭转轴上的键。在一个实施方式中，所述扭转轴构造成在所述对接帽的狭槽与所述扭转轴上的键接合时将旋转转矩施加到所述对接帽。
在另一实施方式中，扭转轴的基端部联接到把柄上的控制钮。在一些实施方式中，扭转钮沿着所述把柄的纵向运动导致所述扭转轴与所述对接帽中的狭槽接合或者脱离。在另一实施方式中，当所述扭转轴上的所述键与所述对接帽的狭槽接合时，所述控制钮的旋转导致所述扭转轴和对接帽旋转。在再一实施方式中，所述控制钮沿着所述把柄的纵向运动使得所述扭转轴和圈套器在纵向上移动。
在导管的一些实施方式中，所述圈套器包括多个环。在其它实施方式中，所述圈套器包括单个环。在一个实施方式中，所述单个环包括垂直于所述导管轴的环。在其它实施方式中，当所述圈套器在末端方向上行进超过所述导管轴时，圈套器偏离所述导管的纵向轴线。
提供了一种无引线起搏器和回收系统，包括无引线心脏起搏器和递送导管，所述无引线心脏起搏器具有回收结构，所述回收结构用至少一个柔性柱（flexiblestem）联接到起搏器，所述递送导管包括：把柄；导管轴，所述导管轴联接到所述把柄；圈套器，所述圈套器布置在所述导管轴内，并且能够在末端方向上延伸超过所述导管轴；对接帽，所述对接帽布置在所述导管轴的末端部上，所述对接帽能够独立于所述导管轴旋转，并且被尺寸设计且构造成接收所述无引线心脏起搏器的回收结构；和扭转轴，所述扭转轴布置在所述导管轴内，并且能够选择性地连接到所述对接帽，所述扭转轴构造成在连接到所述对接帽时在所述导管轴内旋转以将旋转转矩施加到所述对接帽，并且在所述起搏器布置在所述对接帽中时将旋转转矩施加到所述无引线心脏起搏器。
在一些实施方式中，所述导管还包括布置在所述对接帽的内表面上的干涉结构，所述干涉结构构造成与所述起搏器上的相应的干涉结构接合。在一些实施方式中，所述干涉结构包括脊。
在一些实施方式中，所述导管还包括布置在所述对接帽内侧的狭槽，所述狭槽构造成接合所述扭转轴上的键。在一个实施方式中，所述扭转轴构造成在所述对接帽的狭槽与所述扭转轴上的键接合时将旋转转矩施加到所述对接帽。
在另一实施方式中，所述扭转轴的基端部联接到所述把柄上的控制钮。在一些实施方式中，扭转钮沿着所述把柄的纵向运动导致所述扭转轴与所述对接帽中的狭槽接合或者脱离。在另一实施方式中，当所述扭转轴上的所述键与所述对接帽的狭槽接合时，所述控制钮的旋转导致所述扭转轴和对接帽旋转。在再一实施方式中，所述控制钮沿着所述把柄的纵向运动使得所述扭转轴和圈套器在纵向上移动。
在导管的一些实施方式中，所述圈套器包括多个环。在其它实施方式中，所述圈套器包括单个环。在一个实施方式中，所述单个环包括垂直于所述导管轴的环。在其它实施方式中，当所述圈套器在末端方向上行进超过所述导管轴时，所述圈套器偏离所述导管的纵向轴线。
另外，提供了一种从患者回收医疗装置的方法，包括：将导管的圈套器定位成接近所述医疗装置的回收结构；用所述圈套器抓住所述医疗装置的回收结构；将所述圈套器沿基端方向拉入到所述导管中，以将所述医疗装置的回收结构定位在所述导管的对接帽内；以及将来自所述对接帽的旋转转矩施加到所述医疗装置，以将所述医疗装置从患者的组织旋出。
在一些实施方式中，所述医疗装置包括无引线心脏起搏器。
在一个实施方式中，施加旋转转矩步骤还包括：使联接到所述对接帽的扭转轴旋转。在另一实施方式中，施加旋转转矩步骤还包括：使所述扭转轴上的键结构与所述对接帽中的匹配狭槽接合。
在一些实施方式中，所述方法还包括：用保护套覆盖所述医疗装置以及将装置从患者除去。
在一些实施方式中，抓住步骤还包括：用所述圈套器的环抓住所述回收结构。在其它实施方式中，抓住步骤还包括：使圈套器套筒在末端方向上行进过所述圈套器，以使圈套器陷入（collapse）。
附图说明
图1示出了起搏器回收导管系统的一个实施方式。
图2A-2C示出了回收导管系统的末端部的各种近景图。
图3A-3B示出了回收导管系统的保护套。
图4示出了包括有把柄的回收导管系统的基端部。
图5A-5B示出了回收导管系统的把柄的操作。
图6A-6C示出了包括有在导管轴中的预弯弯曲部的回收导管系统的各种实施方式。
图7A-7E示出了回收导管系统的对接帽的多个实施方式。
图8A-8C示出了在导管未与起搏器对准时的由回收导管系统回收的起搏器。
图9A-9B是具有回收结构的起搏器的一个实施方式的各种视图。
图10A-10B是具有回收结构的起搏器的另一实施方式的各种视图。
具体实施方式
描述了包括一个或者多个无引线心脏起搏器或者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，同时通过一个或者多个改进延伸了性能、功能性和操作特性。
在心脏起搏系统的一些实施方式中，以没有位于胸部区域或者腹部中的脉冲发生器、没有从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关于用于传输通信的电池电力的额外需求的方式提供心脏起搏。
构造成实现这些特性的心脏起搏系统的实施方式包括这样的无引线心脏起搏器，其大致包封在适于布置在或者附接至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，用以提供用于起搏、感测和通信例如双向通信的电力。可选地，壳体能够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。
在一些实施方式中，心脏起搏器能够适于递送并植入到人体的组织中。在具体实施方式中，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的两个或者更多个电极而植入到心脏组织附近在心脏腔室的内壁或者外壁上，用于在从体内的至少一个其它装置接收到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（LeadlessCardiacPacemakerSystemforUsageinCombinationwithanImplantableCardioverter-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（LeadlessCardiacPacemaker）”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（LeadlessCardiacPacemakerSystemwithConductiveCommunication）”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（LeadlessCardiacPacemakerTriggeredbyConductiveCommunication）”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（RateResponsiveLeadlessCardiacPacemaker）”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（ProgrammerforBiostimulatorSystem）”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（DeliverySystemforImplantableBiostimulator）”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（LeadlessCardiacPacemakerandSystem）”的第PCT/US2006/040564号并在2007年4月26日公布为WO07047681A2的国际申请。
在所述主固定机构之外，诸如螺旋线，一些起搏器可还包括辅助固定机构，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。
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诸如旋拧到心肌层中的螺钉或者螺旋状构件而固定到内脏内植入部位。在故障情况下，能够急剧地（在植入过程中）或者在微创侵入地植入后的一段时间之后慢性地回收生物激励器的无引线起搏器是非常合乎需要的。
图1示出了构造用于从患者回收无引线起搏器102的起搏器回收导管100。更具体地，导管100构造成从患者的心脏除去无引线心脏起搏器。回收导管100能够包括对接帽104、导管轴106、保护套107、把柄108、圈套器滑动器110、导向件导管轴111、偏转臂112和冲洗口114a、114b和114c。
无引线心脏起搏器102能够是例如类似于参考应用中的上述起搏器。导管轴能够由编带轴（braidedshaft）（例如，带有不锈钢编带的pebax）制成，并且能够在整个轴上包括具有不同刚性的各段。偏转钮112可用于在除去起搏器期间调向和引导所述导管。圈套器滑动器110能够构造成控制圈套器的操作，以捕获无引线心脏起搏器，并且将稍后更详细地描述。冲洗口114a、114b和114c可用于将生理盐水或者其它流体通过导管、导向件导管和起搏器捕获套流出。
套管107能够在纵向上行进过导管轴106和导向件导管轴111，以在回收期间覆盖起搏器，并且阻止起搏器捕获到或损及组织。在一些实施方式中，套筒能够包括放射遮蔽覆层，诸如硫酸钡，或者替代地能够包括位于套筒末端处的铂或者金属结构，从而在除去之前，用户能够在目视观察时确定套筒完全地覆盖起搏器的时刻。
图2A示出了图1所示的起搏器回收导管100的末端部的一个实施方式的近景图。回收导管的末端部能够包括：圈套器203，其构造成抓住无引线心脏起搏器或者其它医疗装置；和对接帽204，其构造成允许在起搏器与圈套器接合之后将无引线起搏器与回收导管对接。图2A还示出了在对接帽204处终止的导管轴206和沿着所述轴略靠近对接帽和无引线起搏器定位的保护套207。
如图2A所示，圈套器203能够包括从导管轴延伸的至少一个环216。随着圈套器从对接帽204在回收系统的末端方向上行进，环的尺寸能够伸展，以辅助用户将圈套器定位在要回收的起搏器周围或附近。在一些实施方式中，如在图2A中，圈套器能够包括多个环，诸如三个环。但是，能够使用任意数目的环，只要导管轴包含足够的容积以收纳所述环即可。
在另一实施方式中，如图2B中所示，圈套器能够包括仅单个环。另外如图2B中所示，所述环能够包括任意数目的结构218，以辅助抓住起搏器或者医疗装置用于回收。在图2B中，结构218能够包括例如缺口结构。在一些实施方式中，圈套器的环能够相对于导管轴的中心偏轴地定位，以在除去期间辅助保持起搏器与导管一致。例如，在图2B中，单环圈套器203能够包括缺口结构218，并且被定位成相对于导管轴206的纵向轴线偏轴。由于圈套器与导管偏轴，则通过将导管定位成邻近起搏器并且允许所述环接触起搏器的壳体，圈套器能够圈在起搏器的回收结构220周围。由于导管被背离起搏器拉动，圈套器能够在起搏器上滑动，并且能够允许缺口结构218接合起搏器的回收结构。
图2C示出的是，圈套器203正抓住无引线心脏起搏器202的回收结构220。在示出的实施方式中，圈套器锁紧套筒205能够从导管的对接帽204在末端方向上行进过圈套器。由于圈套器锁紧套筒沿着圈套器在末端方向上行进，其能够导致圈套器的环尺寸减小，从而抓住起搏器的回收结构220或者锁定到回收结构220上。在一些实施方式中，圈套器锁紧套筒205还能够包括在导管的整个长度上延伸的扭转轴。稍后将更详细地描述扭转轴的细节，但一般地，扭转轴能够独立于导管轴旋转并且联接到导管的对接帽，以将旋转转矩施加到对接帽，并且由此施加到要回收的起搏器或者医疗装置。与其中圈套器包括仅单个环的实施方式相比，在其中圈套器包括多个环的实施方式中，所述环之一将抓住起搏器是更为可能的。
图3A示出了回收导管的末端部的近景图，其中圈套器锁定到无引线起搏器302的回收结构（未示出）上并且对接在对接帽304中。在一些实施方式中，如稍后将更详细地说明的，对接帽能够包括构造成与起搏器本身上的相应键或结构配合并接合的键或者干涉结构。在一些实施方式中，对接帽上的键或者狭槽能够匹配起搏器本身的回收结构的独有形状或者结构。由于对接帽上或中的键或者狭槽能够配合且接合起搏器上的键或者狭槽，回收导管能够构造成将转矩施加到起搏器，以将起搏器从组织旋出且除去。图3A另外示出了沿着回收系统的导管轴略靠近对接帽304定位的保护套。
如图3A所示，对接帽304能够包括球轴承309，球轴承309允许对接帽相对于导管轴的其余部分自由旋转。这有效地降低了来自导管主体的拆卸转矩和附加力，对接帽能够选择性地联接到扭转轴（未示出），该扭转轴延伸通过导管的长度直至把柄上的扭转钮（如下所述）。当扭转轴联接到对接帽时，扭转钮的旋转或者致动使得扭转轴旋转，从而使对接帽304在回收导管的端部旋转。在一些实施方式中，对接帽能够包括键接部分或者干涉结构，以在旋出时将附加力矩施加到起搏器。
在图3B中，保护套307示出为布置在无引线心脏起搏器之上，并且定位在导向件导管轴311的末端处。如上所述，保护套能够构造成滑过起搏器，以防止在除去起搏器期间起搏器的任何尖锐边缘或者结构扯裂、破坏或者捕获到组织上。保护套能够沿着导管的纵向轴线滑动，以允许用套管覆盖和不覆盖起搏器。在一些实施方式中，保护套能够包括图3B所示之外的其它形式的因素。例如，在其中整个装置上的营养生长明显的一些回收方案中，保护套可具有较大直径以允许装置尺寸的增大。
关于图1-3B的上述描述能够用以例示从患者回收医疗装置或者无引线心脏起搏器的方法的一个实施方式。首先，回收导管能够进入患者，直到导管的对接帽位于起搏器附近。接着，回收导管的圈套器能够从导管向外在末端方向上行进，以围绕起搏器的回收结构。一旦圈套器围绕起搏器的回收结构，则圈套器锁紧套筒/扭转轴能够沿着圈套器在末端方向上行进以闭合圈套器，从而导致圈套器抓住起搏器的回收结构。接着，圈套器和圈套器锁紧套筒能够被朝向导管的对接帽在基端方向上拉动，以接合起搏器的基端或者回收结构。然后，旋转转矩能够被导管经由扭转轴和对接帽而施加到起搏器，以将起搏器从组织旋出。保护套能够行进过起搏器，进而起搏器能够从患者除去。
图4是回收导管的基端部段的视图，示出了起搏器捕获套413、把柄408、圈套器滑动器410、偏转臂412和冲洗口414a、414b和414c。包括导管的带有对接帽的部分（以上示出）的、导管的末端部的偏转和调向能够通过操纵把柄408的偏转臂412来实现。圈套器的环的打开和闭合（如图2A-2C所示）能够通过在基端方向和末端方向上操纵把柄上的圈套器滑动器410来实现。虽然偏转臂和圈套器滑动器示出为机械结构，但应理解，能够使用各种方案调向导管和操纵圈套器。例如，把柄能够包括任意数目的机械结构，诸如旋钮或者滑动杆，或者替代地能够采用带有按钮和电动机或者液压活塞的电子或者液压系统。一旦起搏器被套住并从患者心脏内除去（例如，从右心室内除去），则起搏器能够被拉入到捕获套413中。然后，捕获套和起搏器能够从插入在患者内（例如在股静脉中）的引入器/套管针一起退出。捕获套允许起搏器穿过由引入器设置的止血密封，而不破坏本身或引入器的密封。
把柄的一部分能够包括扭转钮422，扭转钮422控制回收导管的圈套器和/或对接帽的旋转。扭转钮能够经由扭转轴（未示出）联接到对接帽，扭转轴在回收导管的整个导管轴延伸。扭转钮也能够联接到同样在整个导管轴上延伸的圈套器。扭转钮的顺时针或者逆时针旋转能够导致扭转轴的旋转，且由此导致对接帽的旋转。扭转钮沿着把柄的纵向运动能够使得圈套器在导管内在纵向上滑动。
图5A-5B示出了把柄上的各种结构的操纵如何控制导管末端部上的圈套器和圈套器锁紧套筒。在图5A中，使得圈套器滑动器510在末端方向或者向前滑动能够使得圈套器锁紧套筒505行进过圈套器，从而导致圈套器绕起搏器502的回收结构闭合。因为锁紧套筒行进过圈套器，圈套器环的直径靠拢，这将圈套器环锁定到起搏器的回收结构上。接着，扭转钮522能够在基端方向上移动，如图5B所示，从而将圈套器和圈套器锁紧套筒在基端方向上拉动，并且导致起搏器502接触对接帽504内并与之对接。在一些实施方式中，将圈套器锁紧套筒在基端方向上拉动能够导致圈套器接合对接帽并且与对接帽联接。当圈套器锁紧套筒（另外称为扭转轴）联接到对接帽时，扭转套筒的旋转同样导致对接帽旋转。
图6A示出了具有预弯导管轴的起搏器回收导管600的一个实施方式。导管可包括末端弯段624，以增强回收导管的调向和导航。在一些实施方式中，末端弯段能够通过提供组织和脉络结构可能缺乏的机械支架而改进回收导管的调向和导航。在回收系统的一个实施方式中，导向件导管的末端段可以预弯曲至90°角度和30mm半径。导管可包括位于基端上的冲洗口，以允许导向件导管轴腔的抽吸或者灌注（aspirationorirrigation）。图6B是带有退回的圈套器的回收导管的末端段的近景图，示出了导管轴的末端弯段624。在一些实施方式中，所述轴能够包括从0°到180°的弯曲角和20-50mm的弯曲半径。图6B示出位于起搏器602附近的回收导管，其中圈套器退回到导管中。
图6C是带有退回的圈套器的回收导管的末端段的另一近景图，示出了近似180°的末端弯段606。在该实施方式中，180°的末端弯段使得回收导管能够达到起搏器，其中起搏器的基部盖相对于导管的进入点旋转180°。
图7A-7C示出了对接帽704的一个实施方式的各种视图。图7A-7C的对接帽可用在上述的系统中。在图7A中，对接帽的末端顶部能够包括贝壳形结构726。如图7A所示，该贝壳形结构能够包括进入对接帽的末端中的一系列弯段或切口。图7A示出了四个贝壳形结构，但在其它实施方式中，能使用不同数目的贝壳形结构，诸如一个、两个、三个或多于四个贝壳形结构。所述贝壳形结构被构造成在回收期间防止对接帽结合在垂直于无引线起搏器的构造中，如稍后将描述的。所述贝壳形结构能够不仅包括如所示的弯曲切口，而且还能够向内朝对接帽内部成梯度或偏斜。这一结构能够辅助对接帽呈与要回收的医疗装置对准且共线的构造。
图7B是图7A的对接帽的剖面图，并且示出了布置在对接帽704内部的键接部分或者干涉结构728。所述键接部分能够构造成与要回收的医疗装置上的匹配键接部分或结构对准或接合。例如，以上述的无引线心脏起搏器为例，起搏器的回收结构能够包括设计成与对接帽的键接部分728接合的相应键接部分或者结构。当对接帽旋转时，键接部分能够彼此接合以提供附加力矩到起搏器，诸如当将起搏器从组织旋出时。
图7C示出了对接帽的透视图，包括有布置在对接帽704内部的干涉结构728。图7C示出了诸如无引线心脏起搏器的医疗装置的回收结构720，该回收结构720布置在对接帽内并且接触对接帽的干涉结构728。如图7C所示，回收结构能够以某一角度布置在对接帽内，但仍接合起搏器的干涉结构。如稍后将更为详细地描述的，当回收结构720通过柔性柱或者柔性附接件附接至起搏器时，其允许回收结构在其在对接帽内被拉动时弯折。这允许对接帽仍将旋转转矩经由干涉结构728施加到回收结构和起搏器，即使在起搏器未与回收导管和对接帽纵向对准也是如此。
图7D示出了从末端看往对接部分的对接帽704的由顶向下的视图。如所示的，对接帽能够包括凹进的狭槽730，所述狭槽730的尺寸和形状设置成接收回收导管的扭转轴(或圈套器锁紧套筒)的键结构。在图7D中，凹进的狭槽730图示为是方形形状。因此，该凹进的狭槽的尺寸和构造被设置成接收在扭转轴上具有方形形状的键。应理解，能够使用任何尺寸或形状的凹进的狭槽，并且扭转轴上的相应键结构的尺寸和形状应该类似地被设置成与狭槽匹配。
当扭转轴的键结构与对接帽的凹进的狭槽730对准时，扭转轴被有效联接到导管的对接帽。该联接允许扭转轴将旋转转矩施加到对接帽。如果扭转轴在末端方向上行进通过狭槽730，而使狭槽不与扭转轴的键结构对准，则扭转轴并不联接到对接帽，并且这两者相对彼此自由旋转。由此，当扭转轴(本文也称为圈套器滑动器)在末端方向上行进以闭合圈套器，扭转轴能够从对接帽脱离。当扭转轴和圈套器然后在基端方向上被拉入对接帽中时，扭转轴的键结构能够与对接帽的狭槽730对准，从而允许扭转轴将转矩施加到对接帽，以将起搏器从组织旋出。扭转轴的键结构同样在图7E中示出。
图7D还示出了在对接帽中布置的轴腔731。该轴腔能够例如是扭转轴的中空部分。扭转轴的轴腔能够容纳上述的圈套器，从而允许圈套器相对于对接帽在末端方向上行进。另外如上所述，当圈套器相对于对接帽在末端方向上行进时，使得扭转轴在末端方向上行进过圈套器能够导致圈套器的环绕要回收的起搏器靠拢。
图7E示出了对接帽的另一剖面图。在图7E中，扭转轴或者圈套器锁紧套筒705已在对接帽中略行进，图示了扭转轴的键结构733从对接帽的狭槽730脱离。当键扭转轴从对接帽脱离时，如上所述，扭转轴的旋转并不导致对接帽旋转。但是，如果图7E的键结构733被在基端方向上拉回以接合对接帽的狭槽730，则扭转轴和对接帽将联接在一起，并且扭转轴的旋转将施加旋转转矩到对接帽。
图8A-8B示出了对接帽804的各种实施方式，该对接帽804具有与医疗装置或者起搏器802接合的贝壳形结构826。如上所述，在图8A中，对接帽的末端部上的贝壳形结构826能够阻止对接帽在回收期间与医疗装置垂直地结合。在图8A中，回收导管和对接帽804示出为以大体上垂直的构造接近起搏器802。为简单起见，以无圈套器的方式示出了导管(如上所述)。参考图8B，一旦圈套器(未示出)已经抓住起搏器802的回收结构820，则由于对接帽的贝壳形结构826，导管和对接帽804能够向上摆动，如箭头AA所示。图8C示出了因贝壳形结构826而与起搏器802的回收结构820成共线构造的对接帽804和回收导管。
图9A-9B和10A-10B示出了无引线心脏起搏器上的回收结构的各种实施方式的多个视图。这些图中示出的回收结构能够由本文所述的回收导管的圈套器抓住，并且还能够构造成对接在回收导管的对接帽中。
在图9A-9B中，回收结构包括“按钮”或者圆形的抓取结构932。所述抓取结构932能够经由至少一个柔性柱934附接至起搏器902。当回收尝试期间回收导管从起搏器偏轴时，通过允许抓取结构和所述柱“弯折”到对接帽中，柔性柱允许起搏器更易于捕获到对接帽中。所述柔性柱还允许抓取结构932将其本身定向在圈套器中并且补偿圈套器的不对称性，从而允许其将对接帽与起搏器对准。此外，柔性柱的偏转允许从导管到无引线起搏器的转矩传动。柔性柱能够由诸如镍钛诺、不锈钢或者钛缆线、MP35N或者其它类似材料的材料制成。柔性柱可以通过激光焊接、钎焊或者本领域已知的其它制造工艺连接到无引线起搏器的抓取结构和基端。
另外如图9A中所示，起搏器902的基端部能够包括键结构936。键结构936的尺寸和构造能够被设置成与对接帽内的干涉结构匹配，如上所述。起搏器的键结构以及对接帽和导管的干涉结构能够允许导管的扭转轴和对接帽施加旋转转矩到起搏器，诸如用以在回收期间将起搏器从组织旋出。
图10A-10B示出了起搏器1002上的“钩形”回收结构1032的另一实施方式。钩形的基端帽能够允许圈套器更易于抓住。所述“钩形”回收结构能够提供易接近但仍防止损伤的表面，以供圈套器抓住。在一些实施方式中，钩形结构的底座部分1034能够包括柔性材料，如上文图9A-9B中关于“按钮”状回收结构的柔性柱所描述的。钩形的回收结构也能够包括切口1038，切口1038能够作用为与图9A-9B中上述的键结构类似的目的。切口能够接合例如对接帽或者回收导管中的类似地成形的结构，以允许导管将旋转转矩施加到起搏器用于将起搏器从组织旋出。
如上所述，对接帽本身能够包括构造成与起搏器的回收结构匹配或接合的切口或者凹进的狭槽。例如，图9A-9B中的圆形回收结构能够与对接帽内的类似地成形的凹进的狭槽相匹配。类似地，图10A-10B中的钩形回收结构能够与对接帽内类似地成形的凹进的狭槽相匹配。
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，单数形式“一”、“和”、“所述”和“该”包括多个引用，除非在上下文中明显指出。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“起搏器回收系统和方法（PacemakerRetrievalSystemsandMethods）”的第61/422,622号美国临时专利申请的优先权，该申请的全部内容通过引用合并入本文。
合并参考
本说明书中提及的全部公布和专利申请通过引用合并于此，如同每个单独的公布或专利申请被具体且分别地指示为通过引用合并入本文。

Claims (23)

1.一种用于从患者回收医疗装置的导管，包括：
把柄；
导管轴，所述导管轴联接到所述把柄；
圈套器，所述圈套器布置在所述导管轴内，并且在末端方向上延伸超过所述导管轴；
对接帽，所述对接帽布置在所述导管轴的末端部上，所述对接帽能够独立于所述导管轴旋转；和
扭转轴，所述扭转轴布置在所述导管轴内，并且能够选择性地连接到所述对接帽，所述扭转轴构造成在连接到所述对接帽时在所述导管轴内旋转，以将旋转转矩施加到所述对接帽，
其中，所述导管还包括：布置在所述对接帽的内表面上的干涉结构，所述干涉结构构造成与要回收的医疗装置上的相应的干涉结构接合，
其中，所述扭转轴的基端部联接到所述把柄上的控制钮，扭转钮沿着所述把柄的纵向运动导致所述扭转轴与所述对接帽接合或者脱离，
所述控制钮沿着所述把柄的纵向运动使所述扭转轴和圈套器在纵向上移动，
当所述圈套器在末端方向上行进超过所述导管轴时，所述圈套器偏离所述导管的纵向轴线。
2.根据权利要求1所述的导管，其中，所述干涉结构包括脊。
3.根据权利要求1所述的导管，还包括布置在所述对接帽内侧的狭槽，所述狭槽构造成接合所述扭转轴上的键。
4.根据权利要求3所述的导管，其中，所述扭转轴构造成在所述对接帽的狭槽与所述扭转轴上的键接合时将旋转转矩施加到所述对接帽。
5.根据权利要求1所述的导管，其中，扭转钮沿着所述把柄的纵向运动导致所述扭转轴与所述对接帽中的狭槽接合或者脱离。
6.根据权利要求4所述的导管，其中，当所述扭转轴上的所述键与所述对接帽的狭槽接合时，所述控制钮的旋转导致所述扭转轴和对接帽旋转。
7.根据权利要求1所述的导管，其中，所述圈套器包括多个环。
8.根据权利要求1所述的导管，其中，所述圈套器包括单个环。
9.根据权利要求8所述的导管，其中，所述单个环包括与所述导管轴垂直的环。
10.一种无引线起搏器和回收系统，包括：
无引线心脏起搏器，所述无引线心脏起搏器具有回收结构，所述回收结构用至少一个柔性柱联接到起搏器；以及
递送导管，所述递送导管包括：
把柄；
导管轴，所述导管轴联接到所述把柄；
圈套器，所述圈套器布置在所述导管轴内，并且在末端方向上延伸超过所述导管轴；
对接帽，所述对接帽布置在所述导管轴的末端部上，所述对接帽能够独立于所述导管轴旋转，并且被尺寸设计且构造成接收所述无引线心脏起搏器的回收结构；和
扭转轴，所述扭转轴布置在所述导管轴内，并且能够选择性地连接到所述对接帽，所述扭转轴构造成在连接到所述对接帽时在所述导管轴内旋转以将旋转转矩施加到所述对接帽，并且在所述起搏器布置在所述对接帽中时将旋转转矩施加到所述无引线心脏起搏器，
其中，所述无引线起搏器和回收系统还包括布置在所述对接帽的内表面上的干涉结构，所述干涉结构构造成与所述起搏器上的相应的干涉结构接合，
其中，所述扭转轴的基端部联接到所述把柄上的控制钮，扭转钮沿着所述把柄的纵向运动导致所述扭转轴与所述对接帽接合或者脱离，
所述控制钮沿着所述把柄的纵向运动使所述扭转轴和圈套器在纵向上移动，
当所述圈套器在末端方向上行进超过所述导管轴时，所述圈套器偏离所述导管的纵向轴线。
11.根据权利要求10所述的无引线起搏器和回收系统，还包括布置在所述对接帽内侧的狭槽，所述狭槽构造成接合所述扭转轴上的键。
12.根据权利要求11所述的无引线起搏器和回收系统，其中，所述扭转轴构造成在所述对接帽的狭槽与所述扭转轴上的键接合时将旋转转矩施加到所述对接帽。
13.根据权利要求10所述的无引线起搏器和回收系统，其中，扭转钮沿着所述把柄的纵向运动导致所述扭转轴与所述对接帽中的狭槽接合或者脱离。
14.根据权利要求12所述的无引线起搏器和回收系统，其中，当所述扭转轴上的所述键与所述对接帽的狭槽接合时，所述控制钮的旋转导致所述扭转轴和对接帽旋转。
15.根据权利要求10所述的无引线起搏器和回收系统，其中，所述圈套器包括多个环。
16.根据权利要求10所述的无引线起搏器和回收系统，其中，所述圈套器包括单个环。
17.一种利用如权利要求1-9所述的导管从患者回收医疗装置的方法，包括：
将导管的圈套器定位成接近所述医疗装置的回收结构；
用所述圈套器抓住所述医疗装置的回收结构；
将所述圈套器沿基端方向拉入到所述导管中，以将所述医疗装置的回收结构定位在所述导管的对接帽内；以及
将来自所述对接帽的旋转转矩施加到所述医疗装置，以将所述医疗装置从患者的组织旋出。
18.根据权利要求17所述的方法，其中，所述医疗装置包括无引线心脏起搏器。
19.根据权利要求17所述的方法，其中，施加旋转转矩步骤还包括：使联接到所述对接帽的扭转轴旋转。
20.根据权利要求17所述的方法，其中，施加旋转转矩步骤还包括：使所述扭转轴上的键结构与所述对接帽中的匹配狭槽接合。
21.根据权利要求17所述的方法，还包括：在将所述医疗装置从患者的组织旋出之后，用保护套覆盖所述医疗装置以及将装置从患者除去。
22.根据权利要求17所述的方法，其中，抓住步骤还包括：用所述圈套器的环抓住所述回收结构。
23.根据权利要求17所述的方法，其中，抓住步骤还包括：使圈套器套筒在末端方向上行进过所述圈套器，以使所述圈套器陷入。
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