CN103249454A - 带有防旋出构造的无引线心脏起搏器 - Google Patents

带有防旋出构造的无引线心脏起搏器 Download PDF

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CN103249454A
CN103249454A CN2011800589311A CN201180058931A CN103249454A CN 103249454 A CN103249454 A CN 103249454A CN 2011800589311 A CN2011800589311 A CN 2011800589311A CN 201180058931 A CN201180058931 A CN 201180058931A CN 103249454 A CN103249454 A CN 103249454A
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biological activator
goes
fixture
heart
helix
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A.凯尔卡汉
E.瓦拉迪
K.J.卡罗尔
P.帕斯帕
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Nanostim Inc
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    • 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
    • A61N1/37518—Anchoring of the implants, e.g. fixation
    • 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
    • A61N1/37512—Pacemakers
    • 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
    • A61N1/18—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

Abstract

本发明涉及一种无引线心脏起搏器，包括壳体、多个与壳体外表面相联的电极和密封地包含在壳体内并且电联接到多个电极的脉冲递送系统，该脉冲递送系统构造成用于寻找壳体内部的能量、产生电脉冲并将电脉冲递送到多个电极。起搏器还包括布置在起搏器的固定装置上或者布置在壳体本身上的防旋出构造。防旋出构造能够构造成阻止固定装置脱离心脏的壁。

Description

带有防旋出构造的无引线心脏起搏器
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附着到心脏内的构造和方法。更具体地，本公开涉及用于阻止无引线心脏起搏器本身从组织旋出的构造和方法。
背景技术
当心脏本身的天生起搏器和/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近端，该引线的远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（male connector molding）具有位于电极引线的近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。
常规方案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-contained and self-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活性接合机构，诸如旋拧到心肌层中的螺钉或者螺旋状构件，固定到心脏内植入部位。
无引线生物激励器从植入部位的脱离可能性将表现出即刻严重的情况，例如从右心室丢失的起搏器可经由肺动脉瓣退出心脏并且在肺中栓塞。
发明内容
提供了一种无引线生物激励器，包括：壳体，所述壳体被定尺寸且构造成植入在患者的心脏内；主固定装置，所述主固定装置附接至所述壳体并且构造成将生物激励器附着到心脏的壁；和防旋出构造，所述防旋出构造布置在所述主固定装置上，并且构造成阻止所述主固定装置脱离心脏的壁。
在一些实施方式中，主固定装置是固定螺旋线。
在其它实施方式中，防旋出构造是至少一个倒刺。在一些实施方式中，所述至少一个倒刺一般背离固定装置的远端指向近端方向。
在一些实施方式中，将固定装置插入到心脏的壁中需要的第一转矩小于将固定装置从心脏的壁移去所需的第二转矩。
在一些实施方式中，防旋出构造是至少一个圆形构造。在其它实施方式中，防旋出构造是至少一个通孔。在另外的实施方式中，防旋出构造是至少一个凹陷。
提供了一种无引线生物激励器，包括：壳体，所述壳体被定尺寸且构造成植入在患者的心脏内；主固定螺旋线，所述主固定螺旋线附接至所述壳体并且构造成将生物激励器附着到心脏的壁；和防旋出螺旋线，所述防旋出螺旋线在所述主固定螺旋线的相反方向上绕制，所述防旋出螺旋线附接至所述壳体。
在一些实施方式中，主固定螺旋线是右旋螺旋线，并且防旋出螺旋线是左旋螺旋线。在其它实施方式中，主固定螺旋线比防旋出螺旋线更长。在另外的实施方式中，防旋出螺旋线定位在主固定螺旋线外侧。
在一些实施方式中，主固定螺旋线是电极。
在其它的实施方式中，防旋出螺旋线构造成随着主固定螺旋线附着到心脏的壁而压缩在组织上。
根据权利要求9所述的无引线生物激励器，其中所述防旋出螺旋线构造成在所述生物激励器从心脏的壁旋出时接合心脏的壁。
一种无引线生物激励器，包括：壳体，所述壳体被定尺寸且构造成植入在患者的心脏内；主固定装置，所述主固定装置附接至所述壳体并且构造成将生物激励器附着到心脏的壁；和防旋出构造，所述防旋出构造布置在所述壳体上，并且构造成阻止所述主固定装置脱离心脏的壁。
在一些实施方式中，主固定装置包括固定螺旋线。
在一些实施方式中，防旋出构造包括多个齿、倒刺或者其它锐化构造。在许多实施方式中，所述齿、倒刺或者其它锐化构造布置在壳体的远端表面上。在一些实施方式中，所述齿、倒刺或者其它锐化构造布置在壳体的锥形表面上。在其它的实施方式中，所述齿、倒刺或者其它锐化构造非对称地布置，以提供仅在主固定装置的旋出方向上的阻力。
在一个实施方式中，将固定装置插入到心脏的壁中需要的第一转矩小于将固定装置从心脏的壁移去所需的第二转矩。
在一些实施方式中，防旋出构造是楔子。在一个实施方式中，所述楔子定位在壳体上在固定装置下方。在其它实施方式中，楔子指向固定装置并且构造成将心脏组织抓取在楔子和固定装置之间，以防止固定装置从心脏的壁的意外脱离。
在一些实施方式中，防旋出构造是至少一个通孔。在其它实施方式中，防旋出构造是至少一个凹陷。
提供了一种无引线生物激励器，包括：壳体，所述壳体被定尺寸且构造成植入在患者的心脏内；主固定装置，所述主固定装置附接至所述壳体并且构造成将生物激励器附着到心脏的壁；和至少一个通孔，所述至少一个通孔布置在所述壳体中，并且构造成促使组织向内生长到所述通孔中以阻止所述主固定装置脱离心脏的壁。
在一些实施方式中，所述至少一个通孔水平地延伸到壳体中。在其它实施方式中，所述至少一个通孔沿着壳体的纵向轴线延伸。在一些实施方式中，所述至少一个通孔具有近似0.005"到0.04"的直径。在其它实施方式中，所述至少一个通孔部分地延伸过壳体的直径。在另外实施方式中，所述至少一个通孔完全地延伸过壳体的直径。在一些实施方式中，所述至少一个通孔被填充生物可吸收材料。
提供了一种阻止无引线生物激励器从患者的心脏意外脱离的方法，包括：将转矩在第一方向上施加到无引线生物激励器，以用主固定装置将无引线生物激励器附着到心脏组织；用防旋出装置将转矩在第二方向上施加到所述组织，以阻止所述无引线生物激励器从组织分离。
在一些实施方式中，在第二方向上的转矩大于在第一方向上的转矩。
提供了一种阻止无引线生物激励器从患者脱离的方法，包括：将无引线生物激励器植入到患者的心脏组织中；用生物可吸收的防旋出构造阻止无引线生物激励器从心脏组织脱离；以及允许所述生物可吸收的防旋出构造被患者在3个月以内吸收。
在一些实施方式中，防旋出构造是缝合。在另外的实施方式中，所述缝合是生物可吸收的。
附图说明
在下面的权利要求书中具体地阐述了本发明的新颖特征。参考下面的阐述了示意性实施方式的详细描述和附图将获得对于本发明的特征和优点的更好理解，其中示意性实施方式利用了本发明的原理，在图中：
图1示出了无引线心脏起搏器或者生物激励器的一个实施方式。
图2a-2f示出了无引线心脏起搏器的布置在固定装置上的防旋出构造的实施方式。
图3a-3c示出了无引线心脏起搏器上的防旋出螺旋线的各种实施方式。
图4a-4f示出了无引线心脏起搏器的布置在壳体上的防旋出构造的实施方式。
图5a-5p示出了具有尖端组件和防旋出构造的无引线心脏起搏器的各种实施方式。
图6a-6e示出了整合在无引线心脏起搏器中的通孔或者部分通孔的各种实施方式。
图7a-7b示出了具有防旋出构造的无引线心脏起搏器的实施方式，所述防旋出构造包括缝合。
具体实施方式
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，同时通过一个或者若干个改进延伸了性能、功能性和操作特性。
在心脏起搏系统的一些实施方式中，以无位于胸部区域或者腹部中的脉冲发生器、无从脉冲发生器分开的电极引线、无通信线圈或天线并且无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。
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系统的各种实施方式。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活性接合机构，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。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 Cardiac Pacemaker System forUsage 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 CardiacPacemaker）”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 Cardiac Pacemaker Systemwith 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（Leadless Cardiac PacemakerTriggered 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 Responsive LeadlessCardiac 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输送系统（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（Leadless CardiacPacemaker 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。
图1示出了无引线心脏起搏器或者无引线生物激励器100。生物激励器能够包括密封壳体102，密封壳体102上布置有电极104和106。如所示的，电极106能够布置在固定装置105上或者整合在固定装置105内，并且电极104能够布置在壳体102上。固定装置105能够是固定螺旋线或者适于将壳体附接至组织诸如心脏组织的其它柔性或刚性结构。在其它实施方式中，电极106可以以各种形式和大小独立于固定装置。壳体还能够包括位于壳体内的电子隔室110，电子隔室110包含操作生物激励器所需的电子部件。密封壳体能够适于植入在人的心脏上或人的心脏中，并且能够例如是筒状、长方形、球形或者任意其它适当形状。
壳体能够包括导电的、生物相容的、惰性的以及阳极化的安全材料，诸如钛、316L不锈钢或者其它类似材料。壳体能够进一步包括布置在导电材料上以将电极104和106分开的绝缘体。绝缘体能够是壳体在电极之间的部分上的绝缘涂层，并且能够包括诸如硅酮、聚氨基、聚对二甲苯的材料，或者是可植入医疗装置通常使用的另一生物相容的电绝缘体。在图1的实施方式中，单个绝缘体108沿着壳体的在电极104和106之间的部分布置。在一些实施方式中，壳体本身能够包括绝缘体来代替导体，诸如矾土陶瓷或者其它类似材料，并且电极能够布置在壳体上。
如图1所示，生物激励器能够进一步包括头部组件112，以将电极104与电极106隔离。头部组件112能够由Tecothane（路博润）或者另一生物相容性塑料制成，并且能够包含陶瓷-金属馈入件（feedthrough）、玻璃-金属馈入件或者本领域已知的其它适当馈入绝缘体。
电极104和106能够包括起搏/感测电极或者返回电极。低偏振化涂层能够施加到电极，例如，诸如铂、铂-铱、铱、铱氧化物、钛氮化物、碳或者通常用以降低偏振效应的其它材料。在图1中，电极106能够是起搏/感测电极，并且电极104能够是返回电极。电极104能够是导电壳体102的不包括绝缘体108的部分。
多种技术和结构能够用于将壳体102附接至心脏的内壁或外壁。螺旋状固定装置105能够使得装置通过导向导管以心内或心外方式插入装置。可产生转矩的导管能够用于旋转壳体并且将固定装置压入于心脏组织中，由此将固定装置（以及另外图1中的电极106）附着成接触可激励组织。电极104能够用作感测和起搏的无关电极。如在常规起搏电极-引线中已知的，固定装置可以被局部地或者全部地涂覆以电绝缘，并且类固醇洗脱基体可以被包括在装置上或装置附近，以使纤维化作用最小化。
在生物激励器上能够包括各种防旋出构造，以提供这样的特征：将生物激励器从组织旋出所需的转矩大于在无这种特征情况下旋出生物激励器所需的转矩。在一些实施方式中，将生物激励器从组织旋出所需的转矩大于将生物激励器进一步旋拧、接合或者再接合到组织中所需的转矩。当防旋出构造提供了该功能时，降低了生物激励器本身从组织不慎旋出或者脱离的机会。应指出，由于组织的穿刺或刺破以及螺旋状空腔的形成，最初将生物激励器插入到组织中所需的转矩较大。由此，在一些实施方式中，防旋出构造仅需要提供：将生物激励器从组织旋出所需的转矩大于在生物激励器已被植入组织中之后（即在组织已被刺破之后）将生物激励器从组织旋出所需的转矩。
现在参考图2a，无引线生物激励器200包括防旋出构造，防旋出构造布置在固定装置上并且构造成阻止生物激励器从组织分离。生物激励器200能够类似于图1中的生物激励器100，由此壳体202、固定装置205、电极206、绝缘体208和头部组件212能够分别对应于上述的壳体102、固定装置105、电极106、绝缘体108和头部组件112。
在图2a中，防旋出构造能够包括布置在固定装置205上的至少一个倒刺214。任意量的倒刺能够沿着螺旋线的长度定位。图2b示出了图2a中的倒刺214的近距图。参考图2b，当固定装置在方向d上插入到组织中时，倒刺214能够在相反方向上指向，以接合组织并且阻止固定装置从组织分离。更具体地，倒刺能够背离固定装置的远端在近端方向上指向。在各种实施方式中，角度α和β能够依据具体应用的转矩需求来调整。例如，角度α和β能够被调整，从而从组织旋出装置所需的转矩大于再旋入或接合到先前穿刺的组织中所需的转矩。在一些实施方式中，α能够在从135°到180°的范围内变化，而β能够在从30°到135°的范围内变化。此外，固定装置上的倒刺的尺寸、数量和/或间隔能够增大或减小，以适应期望的转矩要求。在一些实施方式中，倒刺仅从固定装置向外延伸一小段距离，以允许固定装置旋入到组织中并接合组织，而不会对组织造成过大损伤或损坏。例如，倒刺可以从固定装置向外延伸5mm以下，或者甚至1mm以下。在图2a-2b的实施方式中，倒刺示出为在固定装置的两侧上，但在其它实施方式中，倒刺能够布置在固定装置的仅单个侧上。在其它实施方式中，倒刺能够沿径向偏移，以减小在沿着固定装置的任意给定点处的横截面轮廓。
在图2c-2e中示出了布置在固定装置上或内的防旋出构造的各种其它实施方式。在图2c中，防旋出构造包括布置在固定装置205上的至少一个圆形构造216。该圆形构造能够在固定装置插入时接合组织并且对固定装置提供另外的阻力，以阻止固定装置从组织脱离。在一些实施方式中，所述圆形构造的尺寸能够在近似0.003"到0.030"的直径范围内变化。
参考图2d，防旋出构造能够包括位于固定装置205中的至少一个切口或孔218。切口218构造成且定尺寸为允许组织向内生长到固定装置中，以阻止固定装置从组织脱离。在一些实施方式中，切口218一直延伸通过固定元件205。在其它实施方式中，切口能够是固定元件中的凹陷或者凹坑。在一些实施方式中，切口的尺寸或者直径能够在从近似0.001"到0.010"的直径范围内变化。
现在参考图2e，防旋出构造能够包括布置在固定装置的表面上的粉末或者珠子220。在一些实施方式中，所述粉末或者珠子能够烧结到固定装置上，以增大固定装置的表面面积并且提供额外的磨擦以阻止固定装置脱离组织。
图2f示出了另一实施方式，其中包括倒刺214的防旋出构造与凹口（scallops）215（或者其它切口构造）组合，以促进组织向内生长并且提供磨擦而阻止防旋转。
在上述的一些实施方式中，一个或多个防旋出构造被印制、切割、焊接到、蚀刻到或者以其它方式附接至或者布置在固定装置上。在一个实施方式中，固定装置能够被绕制金属线，并且一个或多个防旋出构造能够通过附加过程被添加到固定装置中。在另一实施方式中，固定装置能够从管以除去方式切割成，并且一个或多个防旋出构造能够在同一过程中形成。
图3a-3c示出了构造成阻止生物激励器从组织分离的防旋出构造的附加实施方式。与上述在图2a-2e中的实施方式相反，其中固定装置或者固定螺旋线本身包括防旋出构造，图3a-3b中的实施方式包括从固定装置分开的防旋出构造。在图3a中，生物激励器300能够包括本文所述的生物激励器中的任一种，由此壳体302、固定装置305和头部组件312能够分别相应于图1中的壳体102、固定装置105和头部组件112。
参考图3a中的生物激励器300的俯视图，能够看到固定装置305在顺时针方向上被绕制，因而断定，通过在顺时针上将生物激励器和固定螺旋线缠绕到组织中，生物激励器300能够附接至组织。生物激励器300能够进一步包括防旋出构造，该防旋出构造包括防旋出螺旋线322。在一些实施方式中，防旋出螺旋线能够定位在固定装置305外侧，并且在固定装置的相反方向上绕制（即，在图3a中的逆时针方向上绕制）。由此，如果固定螺旋线是右旋螺旋线，则防旋出螺旋线是左旋螺旋线，反之亦然。将防旋出螺旋线定位在固定装置外侧会导致与防旋出螺旋线关联的任何组织刺激背离固定装置（并且背离活性起搏电极（如果其布置在固定螺旋线上））而发生。然而，在其它实施方式中，防旋出螺旋线能够定位在主固定装置内侧。
防旋出螺旋线能够是单螺旋线、双螺旋线、三螺旋线等等。在一些实施方式中，参考图3b，防旋出构造能够包括多个防旋出螺旋线324，以对整个固定系统提供提高的稳定性。在其它实施方式中，防旋出螺旋线322或者螺旋线324能够包括倒刺或者其它防旋出构造，诸如以上在图2a-2e中所述的那些。在该例子中，倒刺将仅在防旋出螺旋线以如固定装置或者螺旋线相同的方向上绕制时使用。在固定装置的相反方向上缠绕防旋出螺旋线能够阻止生物激励器从组织脱离，因为生物激励器的任何逆旋转将导致一个或多个防旋出螺旋线接合组织。在一些实施方式中，一个或多个防旋出螺旋线还能够用于感测或者用于诱发响应。
图3c示出了图3a的生物激励器300的侧视图。从图3c能够看出，固定装置305比防旋出螺旋线更长，并且从生物激励器的远端比防旋出螺旋线322延伸得更远。这允许固定装置首先在插入期间接合组织，而防旋出螺旋线并不延伸到组织中。此外，在装置固定到组织中之前，能够阻止防旋出螺旋线与映像或电气测量干涉。在一些实施方式中，固定螺旋线能够完全地接合到组织中，然后生物激励器能够逆向转动以使防旋出螺旋线同样接合组织。在一些实施方式中，防旋出螺旋线能够以与弹簧相同的方式压缩，允许防旋出螺旋线在固定螺旋线插入到组织中时压缩在组织上。在该实施方式中，由与组织接合的防旋出螺旋线导致的任何伤痕组织将定位成背离主固定装置或者固定螺旋线。当固定螺旋线包括电极时，防旋出螺旋线引起的任何伤痕组织被有利地定位成背离电极。照此，防旋出螺旋线并不是辅助固定元件，相反，仅将在生物激励器从组织旋出或松脱时接合组织。在图3c中，防旋出螺旋线示出为是固定装置的高度的近似50%。在其它实施方式中，防旋出螺旋线能够是相对于固定装置的任何尺寸，然而，其通常是固定装置的高度的25-50%。
图4a-4b示出了从固定装置或者螺旋线分开的防旋出构造的其它实施方式。例如，在图4a中，包括壳体402、固定装置405、绝缘体408和头部组件412的生物激励器能够进一步包括布置在头部组件的顶面或最远面上的齿426。在一些实施方式中，所述齿能够非对称地布置，以对固定装置提供仅在旋出方向上的抓取和/或阻力。在图4b中，头部组件412能够包括锥形表面428，并且齿426能够沿着头部组件的顶面或最远面和锥形表面两者布置，以增大防旋出表面面积。
图4c示出了生物激励器的再一实施方式，包括从固定装置分开的防旋出构造。图4c是生物激励器400的远端部分的近距图，示出了头部组件412和固定装置405。在该实施方式中，防旋出构造能够包括定位在头部组件上的楔子或者楔形物429，紧靠近固定装置405与头部组件的接合位置。在图4c中，楔子类似于三角形或者倒刺，但能够使用其它形状和设计。当生物激励器通过固定装置或者固定螺旋线405完全地附着到组织时，组织能够在固定装置和楔子之间变成楔形。当楔子包括指向固定装置的尖锐边缘时，如图4c所示，在楔子和固定装置之间抓取的或者楔入的组织能够导致生物激励器抵抗从组织的旋出和不慎脱离。在图4c中，楔子示出为定位在固定装置下方。但是，在其它实施方式中，一个或多个楔子能够定位在固定装置的内侧和/或外侧表面上。例如，全部三个位置能够独立地或者组合地使用。图4f示出了生物激励器的又一实施方式，具有定位在固定装置405下方的楔子或者楔形物429。
在图4a-4c中，齿示出为竖直向上地指向或者垂直于生物激励器。但是，在其它实施方式中，齿能够相对于一侧成角度，以提高在装置旋出情况下齿接合组织的能力。例如，如果生物激励器在顺时针方向上接合到组织中，则齿可以在生物激励器上在相反方向上成角度，以在生物激励器在逆时针方向上不慎旋转时将附加力施加在组织上。图4d示出了生物激励器的一个实施方式，具有在与固定装置405插入/接合到组织中的方向相反的旋出方向上施力的齿426。
图4e示出了生物激励器的另一实施方式，具有在径向方向上布置在生物激励器周围的齿427，齿427构造成在与固定装置405插入/接合到组织中的方向相反的旋出方向上施力。
现在参考图5a-5k，根据一些实施方式的生物激励器500能够进一步包括防旋出构造，该防旋出构造包括从生物激励器沿径向延伸的一个或多个尖端530。如前所述，生物激励器500能够包括本文所述构造中的任一种，其中包括固定装置505和头部组件512。
在图5a中，生物激励器能够包括布置在头部组件512的远端的相反侧上的两个尖端530。在一些实施方式中，所述尖端能够从生物激励器向外指向，垂直于生物激励器的纵向轴线。所述尖端还能够附接在生物激励器上的任意位置处，但通常将布置在生物激励器的远端部分上，在头部组件512上或附近。所述尖端能够在生物激励器植入于心脏内时对组织诸如心脏壁提供逆向旋转恢复力。参考图5b，生物激励器能够包括多于两个的尖端530，以增大可用以阻止固定装置从组织脱离的构造的数。尖端530通常能够包括材料，诸如硅酮或者柔软的聚氨酯或者其它的生物可吸收聚合物。
在图5c的实施方式中，齿532能够模制在尖端530上。在一些实施方式中，所述齿能够模制在尖端的整个表面上，或者替代地，如图5c所示，所述齿能够仅布置在尖端的在旋出生物激励器时将接合组织的一侧上。因此，在图5c的例子中，如果生物激励器和固定装置在顺时针方向上旋转以接合组织，则如果装置在逆时针方向上旋转，如箭头CC所示，齿532将仅接合组织以提供逆向旋转转矩。在一些实施方式中，所述尖端能够包括生物可吸收材料。
类似地，在图5d中，尖端530能够模制为螺旋形形状，以提供在仅一个方向上的非对称转矩。使用上述其中生物激励器和固定装置在顺时针方向上旋转以接合组织的例子，图5d中的螺旋形形状的尖端530将在组织接合期间朝向生物激励器弯曲或者压缩（例如，顺时针旋转），但是在沿逆时针方向旋转期间，将接合组织并对生物激励器提供逆向旋转转矩，如箭头CC所示。
在以上的图5a-5d中，尖端示出为从生物激励器在垂直于生物激励器的纵向轴线的方向上向外延伸。然而，现在参考图5e，能够看到所述尖端还能够从生物激励器在径向和近端方向上延伸。通过使尖端竖直地成角度，它们能够提供竖向牵引，以有助于防旋出以及有助于生物激励器固定到组织。这能够在一些心脏情况下是特别有用的，诸如在生物激励器布置在心室内时。
图5f-5h示出了另外的实施方式，包括一个或多个尖端530，以提供对生物激励器的防旋出构造。在图5f中，尖端在生物激励器插入到身体中期间能够折叠靠着头部组件512。在一些实施方式中，例如，尖端能够通过引入器或者导管被保持在头部组件上的适当位置中。当生物激励器退出引入器或者导管时，尖端能够向外弹出，以呈现它们的防旋出形状（例如，如图5a或者5e所示）。尖端能够形成用于形状记忆材料，诸如镍钛诺（Nitinol），以呈现预定的防旋出形状。在另一实施方式中，如图5g所示，尖端能够折叠到布置在头部组件512内的空腔532中。在再一实施方式中，如图5h所示，可熔解密封室534（例如，甘露醇、山梨醇等等）能够在植入生物激励器期间包封固定装置505和尖端530。一旦生物激励器插入到身体中，则甘露醇密封室将溶解，允许尖端恢复到它们的防旋出位置。
在图5i-5k中示出了其它的尖端布置。在图5i中，在植入期间，尖端530能够竖直地以及旋转地折叠在生物激励器周围。在图5j的实施方式中，位于距固定装置505的各种距离处的多个尖端能够从生物激励器向外延伸。在图5k中，许多短的尖端530能够布置在头部组件上。这些尖端能够被成形为且倾斜为提供非对称的转矩，这意味着它们能够在一个旋转方向（例如，逆时针）上对其它方向（例如，顺时针）提供更多的旋转摩擦。
在另一实施方式中，如图5l-5m中所示，尖端530能够模制为独立的尖端组件538，并且经由非永久性连接诸如压缩配合或按扣配合被装配到生物激励器的头部组件512上。在体内，尖端将被完全地包封在组织中。如果尖端永久地连接到生物激励器，则该包封将使生物激励器的取出非常困难。但是在这个实施方式中，在取出期间，生物激励器将从尖端组件538分开并且被移除，而尖端组件将永久地留下或被弃置。例如，在取出过程期间，拉力将被施加到生物激励器。一旦拉力超过规定值，则尖端组件将从生物激励器的头部组件分开。接着，生物激励器将被移除，并且仅残余包封的尖端组件。因此，在这一实施方式中，尖端组件到心脏组织的完全内皮化、包封和永久地固定是期望的--其将有助于生物激励器从尖端组件的完全分离，并且其将阻止尖端组件的不慎栓塞。在这一实施方式中，尖端可以具有旨在有助于永久性心脏固定的设计构造，诸如增大的表面粗糙度、通孔、表面处理/涂层等等。在另一实施方式中，上述的任一尖端能够在生物激励器附近变窄，从而在生物激励器的取出期间，尖端能够从装置折断或者断开。
图5n示出了图5l-5m中所示的实施方式的变化。在图5n中，尖端组件538能够通过一个或多个缝合540保持到无引线起搏器上。在一些实施方式中，所述缝合能够是生物可吸收的，以允许尖端在一个或多个缝合已被组织吸收时从生物激励器分开。图5o示出了植入在心脏的腔室内的无引线心脏起搏器或者生物激励器。在这一实施方式中，起搏器能够包括缝合，其附着图5n中描述的尖端组件。图5p示出了单独的取回导管，用以在一个或多个缝合已被组织吸收之后将图5o的起搏器从心脏移除。用生物可吸收材料或者缝合附着图5n中的尖端组件538允许在一个或多个缝合已经溶解时更容易地移除起搏器。
图6a-6e示出了具有用于阻止生物激励器从组织分离的防旋出构造的生物激励器的其它实施方式。在图6a中，通孔636能够水平地延伸通过头部组件612，以促进组织向内生长到并横过生物激励器。图6b是沿着线6b-6b的图6a的横截面图。通孔636关于头部组件的尺寸的相对尺寸能够在图6b中看到。在一些实施方式中，通孔能够具有近似0.005"到0.04"的直径。虽然在图6a-6b中示出了单个的且圆形的通孔，但应理解在生物激励器中能够使用任意数目和形状的通孔，诸如方形、长方形、八边形等等。通孔还能够“颈减”（即，该通孔能够朝装置的中央比其在装置的外侧或者周界具有更窄的直径）。
此外，通孔不必延伸通过整个组件。参考图6c，通孔636能够在头部组件612内部分地延伸。在图6d的实施方式中，通孔在竖直方向上延伸到头部组件中，代替图6a-6c的通孔的水平方向。
图7a-7b分别示出了具有用于阻止生物激励器从组织分离的防旋出构造的生物激励器的又一实施方式的侧视图和俯视图。在图7a-7b中，生物激励器能够包括布置在生物激励器和/或固定装置705上的缝合742。在一些实施方式中，缝合能够是生物可吸收的。缝合能够通过本领域已知的任何方法附着到生物激励器和/或固定装置，诸如通过机械干涉、粘合剂、焊接等等。在一些实施方式中，所述缝合的长度能够近似在1-2mm以下。在其它实施方式中，缝合能够更大。在一些实施方式中，所述缝合能够构造成在近似30-60天之后在组织中生物吸收。在一些实施方式中，缝合能够构造成随着生物激励器插入到组织中而折叠靠着生物激励器或者固定装置，但所述缝合能够构造成在生物激励器和固定装置旋出时向外展开并且接合组织。如图7b所示，在一些实施方式中，所述缝合能够应用为指向固定装置的相反方向。在固定装置的相反方向上缠绕生物激励器能够阻止生物激励器从组织脱离，因为生物激励器的任何逆向旋转将导致所述缝合接合组织。
促进组织向内生长到且通过生物激励器的构造，诸如空腔和通孔，能够增强装置到组织的固定并且阻止生物激励器从组织的旋出和分离。虽然本文所述的许多实施方式包括促进组织向内生长的构造，但应理解，本文所述的许多防旋出构造被构造成在植入之后且在组织有时间生长到装置中之前立即阻止生物激励器从组织意外脱离。在图6e的实施方式中，通孔636与生物激励器的远端面上的孔口成角度。
本文所述的通孔能够是开放的并且无任何的阻塞材料，或者替代地能够被填充快速溶解物质，诸如甘露醇，或者用缓慢的生物可吸收材料填充。在生物激励器植入之前填充通孔或者空腔的优点在于，其消除了被捕集的空气栓塞以及空腔能够用作细菌生长的病灶的风险。
本文所述的防旋出构造旨在阻止生物激励器从组织意外旋出或者脱离。这些特征在生物激励器植入之后的短时间内最为重要（例如，在植入的1-3个月内）。在植入后的1-3个月之后，将具有足够的时间发生内皮化，使得生物激励器由组织完全地包封。被完全地包封的生物激励器本身不慎从组织中旋出的机率被认为较低。
阻止旋出的构造可以设计成在植入后的短时间段中最为有效（例如，在植入之后的第一个1-3个月内）。因此，这些防旋出构造能够由生物可吸收材料制成。一旦它们不再需要阻止生物激励器的旋出，他们能够生物吸收并且消失。由此，本文所述的任何防旋出构造，包括尖端、倒刺、齿、辅助或者防旋出螺旋线以及通孔能够由生物可吸收材料制成，以在植入后的最初1-3个月时间段之后由身体吸收。
布置在固定装置上或内的防旋出构造的各种其它实施方式在图7a-7c中示出。在图7a中，防旋出构造740能够绕制在固定装置705表面周围。在这一实施方式中，防旋出构造740构造成阻止固定装置从组织分离。防旋出构造740能够包括在固定装置插入到组织中时与组织接合的金属线或其它类似材料。在一些实施方式中，防旋出构造能够包括生物可吸收材料。
图7b示出了包括沿着固定装置的长度的切口或者缺口742的固定装置705。如图7b所示，切口742包括进入固定装置中的半圆形切口。这些切口允许组织在固定装置已被插入到组织中之后向内生长。虽然图7b中未示出，但切口能够包括其它的形状，包括三角形、方形、长方形等形状的切口。
图7c示出了包括防旋出构造的固定装置的再一实施方式。在图7c的实施方式中，固定装置705包括通孔744和倒刺746。通孔能够沿着固定装置的长度布置。在图7c的实施方式中，通孔沿着固定装置的主要表面748并且沿着固定装置的狭窄边缘表面750布置。倒刺746图示为仅沿着固定装置的远端部分布置，但在其它实施方式中，倒刺能够沿着固定装置的任意或所有部分布置。在一些实施方式中，倒刺能够包括生物可吸收材料，在固定装置已被插入到组织中之后（例如，植入之后的1-3个月），生物可吸收材料溶解。
图8a-8c示出了其中电极802从固定装置805分开的无引线心脏起搏器的实施方式。图8a和8b分别是具有从固定装置805分开的电极802的起搏器800的侧视图和俯视图。在图8a中，电极安装在从起搏器的主体向外延伸的柔性臂852上。如图8b所示，柔性臂能够从起搏器沿径向向外延伸，以在起搏器开始旋出或者要从组织脱去的情况中提供抵抗组织的另外阻力。所述臂能够包括另外的防旋出构造，诸如通孔、倒刺、齿等等，以进一步阻止防旋出。在一些实施方式中，柔性臂仅在一个旋转方向上是柔性的（例如，将允许无引线起搏器从组织旋出的旋转方向），并且在另一旋转方向上是刚性的或者非柔性的。
图8c示出了具有被置于固定装置805内的电极802的起搏器的替代实施方式。通过将固定装置805旋拧到组织中能够将起搏器附接至组织，这使得电极802接触到组织。防旋出构造854能够被添加，以阻止起搏器本身从组织不慎脱出或旋出。如所示的，防旋出构造854能够从起搏器的主体在远端方向上延伸，以随着起搏器植入而接合组织。
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构造可以独立地阐述和要求，或者与本文所述的任一或多个构造组合。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。
相关申请的交叉参考
本申请根据35U.S.C.119（美国法典第35条119款）要求在2010年10月13日提交的标题为“带有防旋出构造的无引线心脏起搏器（LeadlessCardiac Pacemaker with Anti-Unscrewing Feature）”的61/392,886号美国临时专利申请以及在2010年12月13日提交的标题为“带有防旋出构造的无引线心脏起搏器”的61/422,618号美国临时专利申请的权益，该两个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的公布，包括专利和专利申请，其全部内容通过引用合并于此，如同每个单独的公布被具体地且分别地标示为通过参考来合并。

Claims (39)

1.一种无引线生物激励器，包括：
壳体，所述壳体尺寸设定为且构造成植入在患者的心脏内；
主固定装置，所述主固定装置附接至所述壳体并且构造成将生物激励器附着到心脏的壁；和
防旋出构造，所述防旋出构造布置在所述主固定装置上，并且构造成阻止所述主固定装置脱离心脏的壁。
2.根据权利要求1所述的无引线生物激励器，其中，所述主固定装置是固定螺旋线。
3.根据权利要求1所述的无引线生物激励器，其中，所述防旋出构造是至少一个倒刺。
4.根据权利要求3所述的无引线生物激励器，其中，所述至少一个倒刺总体背离固定装置的远端指向近端方向。
5.根据权利要求1所述的无引线生物激励器，其中，用于将所述固定装置插入到心脏的壁中需要的第一转矩小于用于将所述固定装置从心脏的壁移去需要的第二转矩。
6.根据权利要求1所述的无引线生物激励器，其中，所述防旋出构造是至少一个圆形构造。
7.根据权利要求1所述的无引线生物激励器，其中，所述防旋出构造是至少一个通孔。
8.根据权利要求1所述的无引线生物激励器，其中，所述防旋出构造是至少一个凹陷。
9.一种无引线生物激励器，包括：
壳体，所述壳体尺寸设定为且构造成植入在患者的心脏内；
主固定螺旋线，所述主固定螺旋线附接至所述壳体并且构造成将生物激励器附着到心脏的壁；和
防旋出螺旋线，所述防旋出螺旋线在所述主固定螺旋线的相反方向上绕制，所述防旋出螺旋线附接至所述壳体。
10.根据权利要求9所述的无引线生物激励器，其中，所述主固定螺旋线是右旋螺旋线，并且所述防旋出螺旋线是左旋螺旋线。
11.根据权利要求9所述的无引线生物激励器，其中，所述主固定螺旋线比所述防旋出螺旋线更长。
12.根据权利要求9所述的无引线生物激励器，其中，所述防旋出螺旋线定位在所述主固定螺旋线外侧。
13.根据权利要求9所述的无引线生物激励器，其中，所述主固定螺旋线是电极。
14.根据权利要求9所述的无引线生物激励器，其中，所述防旋出螺旋线构造成随着所述主固定螺旋线附着到心脏的壁而压缩在组织上。
15.根据权利要求9所述的无引线生物激励器，其中，所述防旋出螺旋线构造成在所述生物激励器从心脏的壁旋出时接合心脏的壁。
16.一种无引线生物激励器，包括：
壳体，所述壳体尺寸设定为且构造成植入在患者的心脏内；
主固定装置，所述主固定装置附接至所述壳体并且构造成将生物激励器附着到心脏的壁；和
防旋出构造，所述防旋出构造布置在所述壳体上，并且构造成阻止所述主固定装置脱离心脏的壁。
17.根据权利要求16所述的无引线生物激励器，其中，所述主固定装置包括固定螺旋线。
18.根据权利要求16所述的无引线生物激励器，其中，所述防旋出构造包括多个齿、倒刺或者其它锐化构造。
19.根据权利要求18所述的无引线生物激励器，其中，所述齿、倒刺或者其它锐化构造布置在所述壳体的远端表面上。
20.根据权利要求18所述的无引线生物激励器，其中，所述齿、倒刺或者其它锐化构造布置在所述壳体的锥形表面上。
21.根据权利要求18所述的无引线生物激励器，其中，所述齿、倒刺或者其它锐化构造以非对称方式布置，以仅在所述主固定装置的旋出方向上提供阻力。
22.根据权利要求16所述的无引线生物激励器，其中，用于将所述固定装置插入到心脏的壁中需要的第一转矩小于用于将所述固定装置从心脏的壁移去需要的第二转矩。
23.根据权利要求16所述的无引线生物激励器，其中，所述防旋出构造是楔子。
24.根据权利要求23所述的无引线生物激励器，其中，所述楔子定位在所述壳体上、位于所述固定装置下方。
25.根据权利要求24所述的无引线生物激励器，其中，所述楔子指向所述固定装置并且构造成将心脏组织抓取在所述楔子和所述固定装置之间，以阻止所述固定装置从心脏的壁的意外脱离。
26.根据权利要求16所述的无引线生物激励器，其中，所述防旋出构造是至少一个通孔。
27.根据权利要求16所述的无引线生物激励器，其中，所述防旋出构造是至少一个凹陷。
28.一种无引线生物激励器，包括：
壳体，所述壳体被定尺寸且构造成植入在患者的心脏内；
主固定装置，所述主固定装置附接至所述壳体并且构造成将生物激励器附着到心脏的壁；和
至少一个通孔，所述至少一个通孔布置在所述壳体中，并且构造成促使组织向内生长到所述通孔中，以阻止所述主固定装置脱离心脏的壁。
29.根据权利要求28所述的无引线生物激励器，其中，所述至少一个通孔水平地延伸到所述壳体中。
30.根据权利要求28所述的无引线生物激励器，其中，所述至少一个通孔沿着壳体的纵向轴线延伸。
31.根据权利要求28所述的无引线生物激励器，其中，所述至少一个通孔具有近似0.005"至0.04"的直径。
32.根据权利要求28所述的无引线生物激励器，其中，所述至少一个通孔部分地延伸过所述壳体的直径。
33.根据权利要求28所述的无引线生物激励器，其中，所述至少一个通孔完全地延伸过所述壳体的直径。
34.根据权利要求28所述的无引线生物激励器，其中，所述至少一个通孔被填充生物可吸收材料。
35.一种阻止无引线生物激励器从患者的心脏意外脱离的方法，包括：
将转矩在第一方向上施加到无引线生物激励器，以用主固定装置将无引线生物激励器附着到心脏组织；
用防旋出装置将转矩在第二方向上施加到所述组织，以阻止所述无引线生物激励器从组织分离。
36.根据权利要求35所述的方法，其中，在所述第二方向上的转矩大于在所述第一方向上的转矩。
37.一种阻止无引线生物激励器从患者脱离的方法，包括：
将无引线生物激励器植入到患者的心脏组织中；
用生物可吸收的防旋出构造阻止无引线生物激励器从心脏组织脱离；以及
允许所述生物可吸收的防旋出构造被患者在3个月以内吸收。
38.根据权利要求1所述的无引线生物激励器，其中，所述防旋出构造是缝合。
39.根据权利要求38所述的无引线生物激励器，其中，所述缝合是生物可吸收的。
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