CN103328040A - 具有径向固定机构的无导线起搏器 - Google Patents

具有径向固定机构的无导线起搏器 Download PDF

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CN103328040A
CN103328040A CN2011800613128A CN201180061312A CN103328040A CN 103328040 A CN103328040 A CN 103328040A CN 2011800613128 A CN2011800613128 A CN 2011800613128A CN 201180061312 A CN201180061312 A CN 201180061312A CN 103328040 A CN103328040 A CN 103328040A
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CN103328040B (zh
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A.凯尔卡汉
A.奥斯特罗夫
E.瓦拉迪
P.帕斯帕
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Nanostim Inc
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    • 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
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
    • A61N1/375—Constructional arrangements, e.g. casings
    • A61N1/37518—Anchoring of the implants, e.g. fixation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/056—Transvascular endocardial electrode systems
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    • 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
    • A61N1/375—Constructional arrangements, e.g. casings
    • A61N1/3756—Casings with electrodes thereon, e.g. leadless stimulators

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Abstract

本发明提供一种具有径向固定机构的无导线心脏起搏器。该心脏起搏器可包括与起搏电极分开的并且直径等于或小于起搏器外直径的固定机构。固定机构可允许起搏器被通过起搏器的小于2次旋转插入组织中，以与组织接触放置起搏电极。在一些实施例中，固定机构可包括靠近起搏器远侧部分设置的多个钩或突出部。一个或多个固定机构可配置为刺入患者的心脏内膜，并且大部分位于心肌内。本发明还提供将无导线心脏起搏器传递到心脏中的方法。

Description

具有径向固定机构的无导线起搏器
交叉引用
本申请要求2010年12月20日提交的名称为“LEADLESS PACEMAKERWITH RADIAL FIXATION MECHANISM”的美国临时专利申请No.61/425,064的权益，该申请在此以其全部内容通过引用并入本文中。
通过引用并入
本说明书中提到的所有公开文件和专利申请都以引用的方式并入本文中，如同每一个单独的出版物或专利申请被具体并且单独说明以通过引用并入本文中一样。
技术领域
本发明涉及无导线心脏起搏器，更特别地，涉及其被附接到心脏组织所借助的结构和方法。具体来说，本发明涉及用于将无导线心脏起搏器通过径向固定机构附接到组织的结构和方法。
背景技术
在心脏自身的天然起搏点和/或传导系统不能提供其速率和间隔足以满足患者健康的心房和心室的同步收缩时，通过人工心脏起搏器进行的心脏起搏提供心脏的电刺激。该抗心动过缓的起搏为成千上万的患者提供症状缓解，甚至生命维持。心脏起搏还可提供电过速刺激，以抑制或改变快速性心律失常，同样提供症状缓解，并且防止或终止可能导致心脏性猝死的心律失常。
由目前可得的或传统的起搏器提供的心脏起搏通常通过皮下或肌肉中植入患者胸肌区中或附近的脉冲发生器进行。脉冲发生器参数通常由体外的编程装置通过具有体内的一个感应器和体外的另一个感应器的松耦合互感器，或通过具有体内的一个天线和体外的一个天线的电磁发射器询问和改变。发生器通常连接到一根或多根被植入的导线的近端，其远端容纳一个或多个电极，所述一个或多个电极用于邻近心腔的内壁或外壁定位。导线具有一个或多个绝缘电导体，用于将脉冲发生器连接到心脏中的电极。该电极导线通常具有50到70厘米的长度。
虽然每年不止植入十万个传统的心脏起搏器，但是仍存在很多已知的问题，仅说明所述问题中的一些。例如，脉冲发生器在设置在皮下时，在皮肤中存在鼓胀部分，患者可能感觉不好看、不舒服或恼怒，并且患者可能潜意识地或强迫地推拿或“捻弄”。甚至在没有持续推拿的情况下，皮下脉冲发生器仍可能发生腐蚀、挤出、感染和断开、绝缘损坏或在导线处导体断裂。虽然肌肉或腹部放置可能解决一些烦恼，但是这样的放置涉及更困难的用于植入和调整的手术过程，这可能延长患者的恢复期。
传统的脉冲发生器，无论是胸部或腹部，具有用于连接到电极导线和从电极导线断开的接合部，其将信号输送至心脏或将信号从心脏输送。通常，至少一个凸接头模制件在电极导线近端处具有至少一个接线端子。凸接头与脉冲发生器处接头模制件内的相应的凹接头模制件和接线板结合。通常固定螺钉被拧入每一根导线的至少一个接线板中，以确保电和机械连接。还提供一个或多个O形环，以辅助保持接头模制件之间的电绝缘。通常包括固定螺钉帽或开槽盖，以提供螺钉的电绝缘。接头和导线之间的该简要描述的复杂连接使得出现故障的可能更大。
传统起搏器的其他有问题方面涉及分开植入的脉冲发生器和起搏导线。举另一个示例来说，特别地，起搏导线可能变为感染和发病位置。通过开发独立和自支撑起搏器，或所谓的无导线起搏器可解决与传统的起搏器相关的多个问题，如在上面引用的相关申请中所述。
独立或无导线起搏器或其他生物刺激器通常通过主动接合机构，例如旋入心肌中的螺钉或螺旋构件固定到心脏内植入位置。
发明内容
提供一种无导线心脏起搏器，包括密封壳体；布置在壳体远侧部分上的起搏电极；布置在壳体中的电子封装部，该电子封装部配置为产生起搏信号和将起搏信号传递到起搏电极；和固定机构，其与起搏电极分开，并且布置在壳体的远侧部分上，该固定机构具有小于或等于密封壳体的外直径的直径，并且从固定机构的远端到固定机构的近端包括小于两个旋转圈。
在一些实施例中，固定机构从固定机构的远端到固定机构的近端包括小于一个半旋转圈。在其他实施例中，固定机构从固定机构的远端到固定机构的近端包括小于一又四分之一旋转圈。
在一些实施例中，起搏电极包括圆顶形状。在另外的实施例中，起搏电极被通过柔质弹簧附接到壳体，以减小抵靠心脏组织的压缩力。在另一个实施例中，起搏电极被通过硅酮胶附接到壳体，以减小抵靠心脏组织的压缩力。
在一个实施例中，固定机构包括螺旋件。在一些实施例中，螺旋件旋转小于或等于450度。在其他实施例中，螺旋件至少部分地围绕起搏电极。
在一些实施例中，固定机构包括恒定的直径。在另一个实施例中，固定机构具有2.5mm至5mm的直径。
在一些实施例中，固定机构包括小于1.8mm的纵向长度。在其他实施例中，壳体的远侧部分具有小于密封壳体外直径的外直径。在一些实施例中，固定机构尺寸制成并且配置为得，其在完全旋入心脏组织中时不将患者的心肌穿孔。
在一些实施例中，固定机构包括径向部分和连接部分，该径向部分基本上与壳体的圆周对准，该连接部分将固定机构附接到壳体。在一个实施例中，径向部分基本上垂直于连接部分。在另一个实施例中，连接部分具有小于患者心脏的心肌层厚度的长度。在又一个实施例中，连接部分具有小于或等于1.8mm的长度。在另外的实施例中，固定机构的径向部分配置为位于患者的心脏心肌层内，并且基本上与患者的心脏心脏内膜层接触。在各实施例中，固定机构可进一步包括倒钩，所述倒钩布置在固定机构的径向部分的内表面上。
在另一个实施例中，起搏器配置为在收回过程中接收保护套管，该保护套管具有与密封壳体的外直径类似的内直径。
还提供一种将起搏器固定到心脏中的组织的方法，包括将起搏器的固定机构邻近心脏的心脏内膜定位，所述固定机构具有小于或等于起搏器外直径的直径；用固定机构穿入心脏内膜，和使固定机构旋转小于一又四分之一圈，以基本上将固定机构全部插入心脏的心肌中，并且将起搏器的起搏电极放置为与心脏组织接触。
在一些实施例中，固定机构包括螺旋件。在一些实施例中，起搏器包括无导线心脏起搏器。
在另一个实施例中，该方法进一步包括使用保护套管覆盖起搏器和该固定机构，和将起搏器从患者移除。
附图说明
图1A-1C示出无导线心脏起搏器。
图2A-2D为具有径向固定机构的无导线心脏起搏器的各个视图。
具体实施方式
提供具有至少一个径向固定机构的无导线心脏起搏器的各个实施例。无导线心脏起搏器可通过引导通讯（conducted communication）来通信，代表着从传统起搏系统的实质突破。例如，示例性心脏起搏系统可进行心脏起搏，所述心脏起搏具有很多传统心脏起搏器的优点，同时通过若干改进中的一个或多个扩展了性能、功能和操作特性。
在心脏起搏系统的一些实施例中，心脏起搏在没有设置在胸部区域或腹部中的脉冲发射器、没有与脉冲发生器分开的电极导线、没有通讯线圈或天线、和没有对用于传输通讯的电池功率的进一步要求的情况下被提供。
配置为获得这些特性的心脏起搏系统的一个实施例包括无导线心脏起搏器，其基本上封闭在适用于放置在心腔内部或外部上或附接到心腔内部或外部的密封壳体中。心脏起搏器可具有两个或多个设置在壳体内、上或附近的电极，用于将起搏脉冲传递到心腔肌肉，和可选地，用于从肌肉感测电活动，和用于与体内或体外的至少一个其他装置双向通讯。该壳体可容纳主电池，以给起搏、感测和通讯提供功率，所述通讯例如为双向通讯。壳体可以可选地容纳用于从电极感测心脏活动的电路。该壳体容纳用于从至少一个其他装置通过电极接收信息的电路，并且容纳用于产生通过电极输送的起搏脉冲的电路。该壳体可选地容纳用于将信息通过电极传递到至少一个其他装置的电路，并且可选地容纳用于监测装置健康状况的电路。壳体容纳用于以预定方式控制这些操作的电路。
在一些实施例中，心脏起搏器可适用于传递和植入人体中的组织内。在特定实施例中，无导线心脏起搏器可适用于使用两个或多个电极邻近心腔内壁或外壁上的心脏组织植入，所述电极设置在起搏器壳体上或内，用于在从体内的至少一个其他装置接收促发信号时起搏心腔。
独立或无导线起搏器或其他生物刺激器通常通过主动接合机构，例如旋入心肌中的螺钉或螺旋构件固定到心脏内植入位置。这样的无导线生物刺激器的示例在下面的出版物中有所描述，所述出版物的公开内容以引用的方式并入本文中：(1)US申请No.11/549,599，提交日为10/13/2006，标题为“Leadless Cardiac Pacemaker System for Usage in Combination with anImplantable Cardioverter-Defibrillator”，于4/19/2007公开US2007/0088394A1;(2)美国专利申请No.11/549,581，提交日为10/13/2006,标题为“LeadlessCardiac Pacemaker”,于4/19/2007公开为US2007/0088396A1;(3)美国专利申请No.11/549,591，提交日为10/13/2006，标题为“Leadless Cardiac PacemakerSystem with Conductive Communication”，于4/19/2007公开为US2007/0088397A1;(4)美国专利申请No.11/549,596，提交日为10/13/2006,标题为“Leadless Cardiac Pacemaker Triggered by ConductiveCommunication”，于4/19/2007公开为US2007/0088398A1;(5)美国专利申请No.11/549,603，提交日为10/13/2006，标题为“Rate Responsive LeadlessCardiac Pacemaker”，于4/19/2007公开为US2007/0088400A1;(6)美国专利申请No.11/549,605，提交日为10/13/2006，标题为“Programmer forBiostimulator System”，于4/19/2007公开为US2007/0088405A1;(7)美国专利申请No.11/549,574，提交日为10/13/2006,标题为“Delivery System forImplantable Biostimulator”，于4/19/2007公开为US2007/0088418A1;以及(8)国际申请No.PCT/US2006/040564，提交日为10/13/2006,标题为“LeadlessCardiac Pacemaker and System”，于4/26/2007公开为WO07047681A2。
除了主固定机构，例如螺旋件，一些起搏器可进一步包括第二固定机构，以提供用于将生物刺激器在体内保持在位的另一个结构。第二固定机构可以是主动型的（例如第二固定机构可主动接合心脏内或心脏外的组织），或可以是被动型的（例如第二固定机构没有附接到组织，而是在意外脱开的情况下防止生物刺激器在体内到处移动）。关于第二固定机构的进一步的详细内容可见于美国申请No.12/698,969。
独立或无导线起搏器或其他生物刺激器通常通过主动接合机构，例如旋入心肌中的螺钉或螺旋构件，固定到心脏内植入位置。在出现故障的情况下，非常期望能够急性地（在植入手术过程中）或慢性地（在微创植入后一段时间之后）收回生物刺激器的无导线起搏器。
图1A显示了无导线心脏起搏器100。生物刺激器可包括密封壳体102，其上布置有电极104和106。如图所示，电极106可与固定机构105分离，但是部分地由固定机构105围绕，并且电极104可布置在壳体102上。固定机构105可以是固定螺旋件、多个钩、倒钩或配置为将起搏器附接到组织（例如心脏组织）的其他附接结构。
壳体也可包括在壳体内的电子隔室110，其容纳起搏器运行所需的电子部件，包括例如脉冲发生器、通讯电子装置、电池和用于运算的处理器。密封壳体102可适用于植入在人类心脏上或中，并且可以例如是圆柱状形状、矩形、球形或任何其他适当形状。
壳体可包括导电、生物相容、惰性和阳极安全材料，例如钛、316L不锈钢或其他类似材料。壳体可进一步包括布置在导电材料上的绝缘体，以分隔电极104和106。绝缘体可以是壳体的一部分上的位于电极之间的绝缘涂层，并且可包含例如硅树脂、聚氨酯、二甲苯塑胶或通常用于可植入医疗装置的其他生物相容电绝缘体等材料。在图1A的实施例中，单个绝缘体108沿壳体的一部分布置在电极104和106之间。在一些实施例中，壳体自身可包括绝缘体而不是导体，例如氧化铝陶瓷或其他材料，并且电极可布置在壳体上。
如图1A中所示，起搏器可进一步包括头组件112，用于将电极104与106绝缘。头组件112可由PEEK、Techothane或其他生物相容塑料制造，并且可包括陶瓷-金属引线、玻璃-金属引线或本领域中已知的其他适当引线绝缘体。
电极104和106可包括起搏/感测电极或返回电极。低极化涂层可被涂敷到电极，例如烧结的铂、铂-铱、铱、铱氧化物、氮化钛、碳或通常用于降低极化效应的其他材料。图1A中，电极106可以是起搏/感测电极，并且电极104可以是返回电极。电极104可以是导电壳体102的不包括绝缘体108的部分。
若干技术和结构可用于将壳体102附接到心脏的内壁或外壁。螺旋固定机构105能够使得该装置通过引导导管经心脏内膜或心外膜插入。可扭转导管可被用于旋转壳体，并且将固定装置推入心脏组织中，因而将固定装置（以及图1A中的电极106）固定，以与可刺激的组织接触。电极104可用作用于感测和起搏的中性电极。固定机构可被部分或全部涂覆，用于电绝缘，并且在装置上或附近可包括类固醇洗脱基质，以最小化纤维变性的反应，如传统起搏电极导线中所知的。
图1B-1C示出起搏器100的远端部分的另外的放大视图，包括固定机构105和电极106。如图1B-1C中所示，固定机构可包括螺旋件，其部分包围电极106或围绕电极106旋转。在一些实施例中，固定装置包括等于或小于起搏器自身壳体外直径的直径。在螺旋件实施例中，螺旋件可包括恒定直径，其小于或等于起搏器壳体的外直径。在一个实施例中，固定装置包括小于5mm的直径。在另一个实施例中，固定装置包括大于2.5mm并且小于5mm的直径。在一些实施例中，螺旋固定装置可具有0.005”-0.03”的线直径，和0.5mm到1.5mm的螺距。利用其直径达到壳体直径的固定机构，可增大将固定装置从组织去除所需的拉力，由此减小装置从心脏移开的可能性。而且，固定机构的增大的直径可增大与心脏的心脏内膜层接触的表面积，进一步提高起搏器保持植入在患者中的能力。
图1A-1C的螺旋固定机构可包括从机构的前远侧边缘到机构的附接到起搏器壳体的近侧部分具有小于两个完整圈的线圈。例如，在图1B中，固定机构105的远侧前边缘114距离固定机构的近端116约为一又四分之一圈（约450度）。如图1B中所示，壳体的附接到固定机构的远侧部分可具有小于壳体的主外直径的外直径，以便于固定机构的附接，同时允许固定机构具有小于壳体主外直径的直径。
固定机构105可还包括小于1.8mm的纵向长度L，其被认为是防止植入过程中心肌穿孔的安全长度。因而，在小于2圈（且优选地为小于或等于一又四分之一圈）的情况下，固定机构由此配置为完全旋入心脏组织中，而没有使患者的心肌穿孔。当固定机构完全旋入心脏组织中时，起搏器的电极106与该组织可靠接触。图1C显示了固定机构的远侧前边缘114和近端116的跨越一又四分之一圈或更少圈的、起始和终止点上下倒置的视图。在一些其他实施例中，从固定机构的远端到近端，固定机构可跨越小于2个完整圈。
也如图1A-1C中所示，固定机构可包括抗旋转结构，例如倒钩或缝线，以在该装置已经旋入组织中时，防止该装置反转。
参照图1C中的上下倒置视图，电极106可包括“按钮”或圆顶形状，其略微从起搏器的远端头向远侧地伸出。圆顶状电极可包括1.5-2.5mm的直径，并且可从起搏器的端部向远地侧伸出约0.05”到0.3”。电极106优选为防止损伤表面，并且可从起搏器的端头伸出，以在固定机构105旋入组织中时接触组织。
电极106可通过柔质弹簧（compliant spring）和/或硅酮胶（未示出）电力地和机械地附接到起搏器，以减小施加到待刺激组织的张力或压缩力和摩擦运动。电极相对于待刺激组织的力和/或摩擦运动的减小将导致电极/组织交界处的组织炎症反应的减小，引起纤维化组织形成的减少。该纤维化的减少导致刺激活组织所需的起搏电压/电流更低。
在传统的起搏器中，通常将起搏电极并入到固定装置自身中。但是，由于起搏电极接触在插入过程中由固定装置损坏的组织，因此该组合可能造成对组织的另外的刺激。通过将电极106与固定装置105分离，如图1B-1C中所示，由电极106执行的起搏功能不接触由固定装置105另外刺激的组织。由起搏器的重量和运动产生的力旨在分布到与固定机构直接接触的组织，并且不分布到与电极106接触的、设置在较短距离处的组织。通过将固定位置与刺激位置分离，在远侧端头处的作为结果的纤维化可降低，导致刺激活组织所需的电压和电流降低。而且，由于待刺激的区域不经受由于固定创伤造成的刺激，因此可在即时的电极接触时降低损伤电流，并且可实现低刺激阈值。
图2A-2C示出具有至少一个径向固定机构205的无导线起搏器100的各个视图，该径向固定机构205配置为将起搏器附接到心脏组织。径向固定机构（即钩、突出部、刺等）可径向向外延伸小于或等于无导线心脏起搏器200的壳体最大外直径（OD）的距离，并且可设置在起搏器远侧部分附近。在一些实施例中，在通过起搏器旋转接合到心脏组织中时，径向固定机构可被作为安全的心脏固定机构依靠。
在图2A-2C的系统中，固定机构包括多个围绕电极206布置或布置在电极206附近的L状钩。图2A显示了起搏器的一个实施例，包括三个L状钩或固定机构。图2B显示了图2A的起搏器的上下倒置视图，图2C示出图2A的起搏器的侧视图，显示了固定机构关于电极206的位置。如图所示，钩可包括组织刺入远端头，用于穿刺心脏组织，特别地用于刺入心脏的心脏内膜。
图2A-2C的固定机构205配置为通过缩短的径向圈或螺圈固定到组织。参照图2A，每一个固定机构可包括径向部分209和连接部分211，所述径向部分209基本上平行于起搏器壳体的圆周延伸，并且连接部分211基本上垂直于径向部分并将径向部分连接到起搏器。连接部分可例如具有与心脏的心肌平均厚度大约相同的长度。在使用中，固定机构的径向部分为穿刺并且固定到组织的部分。将所述机构转动或旋转进入组织中，这将使径向部分接合组织，直到达到固定机构的连接部分。通过该装置在连接部分接触组织时的“止动”旋转，这还可提供触觉响应。
在图2A-2C中所示的实施例中，起搏器200包括三个L状径向钩或倒钩。每一个钩可包括起搏器的一圈的例如约60-90度或四分之一到六分之一，以将钩放置在组织内。所用的钩的数量越大，并且因此钩的长度越小，则需要越少的旋转来将组织与钩接合。
图2D示出起搏器200的另一个实施例，该起搏器200具有向远侧弯曲的径向钩205。如图2D中所示，该钩可朝向电极206以从水平位置达到并且包括45度的角度向远侧弯曲。使钩向远侧朝向电极弯曲，这可辅助电极在插入组织过程中与钩接触。在一些实施例中，沿远侧方向的弯曲角度可为30至60度。
固定机构可被封闭在传递和取回导管的可折叠套管（未示出）中，以允许容易地将无导线起搏器传递、重新定位到右心室或心房和从右心室或心房取回。由于固定机构总是具有小于起搏器外直径的直径，因此通过套管取回是可行的。作为对照，具有大于起搏器外直径的倒钩或钩的起搏器很难或不能从患者取回，因为不能使用保护套管覆盖较大的钩或倒钩。适当的取回导管和套管的示例可见于共同待审的申请No.13/324,802。
这些固定机构可还包括防止起搏器旋开的结构，例如倒钩207（所述固定机构上的面向后方的尖头或结构，旨在抓握组织，并且增大移除机构所需的力或扭矩）和/或孔和凹部，其允许组织粘附和内生长。固定机构可与起搏器的中性返回电极电绝缘（浮动的）。由于不止一个固定机构可被结合到起搏器上，因此该想法提供冗余的固定装置。
作为心腔衬里的组织最内层是薄但强韧的心脏内膜。柔软的心肌位于其下面，心脏的肌肉组织包括心脏壁的厚度的大部分。当上面所述的一个或多个固定机构接合在急性心脏组织中时，尖锐的端头刺入心脏内膜并且进入心肌，直到其长度的大部分位于心肌中。正是薄但是结实的心脏内膜提供组织中固定机构的保持力的大部分。图2A-2C中所示的固定机构的钩设计由于心脏内膜和下面的钩之间的大的接触表面，可提供优于替代设计（例如小螺旋件）的超高保持力。更具体地，钩的径向部分209可倾斜并且对准，以最大化钩和心脏内膜之间的接触表面，如图2D中所示。
而且，每一个钩上实施的小的倒钩结构（例如倒钩207）配置为当起搏器被旋开，钩向后从刺入位置滑出时，从里抓住心脏内膜。倒钩结构可设计得非常小（在0.1”数量级），以在去除时充分抓住心脏内膜，但是将必须设计得不可接受地大，以单独地在心肌中具有相同的保持力。
由于小的倒钩207设计用于保持心脏内膜，因此倒钩在每一个机构上的数量和位置为设计灵活性的另一方面。每一个钩205可具有一个或多个倒钩，所述倒钩可设置在远侧、近侧和中间。在一些实施例中，每一个固定机构具有两个倒钩是足够的，一个在近侧设置在每一个钩基部附近，并且一个在远侧设置在每一个固定机构的尖锐尖头附近。当钩适当接合在心肌组织中时，钩的大部分（例如钩的径向部分）已经刺入心脏内膜，并且布置在心脏组织内。在该情况下，近侧倒钩将于是直接设置在心脏内膜后方；在仅角度旋开几度之后，这些近侧倒钩将立即抓住心脏内膜，并且防止进一步旋开。在钩没有100%接合在组织中的情况下，设置靠近固定机构端部的远侧倒钩；只要已经进行几度接合，则这些远侧倒钩将在组织中，并且可被依赖来阻止取出。
具有倒钩的固定机构通过本领域中技术人员已知的多种方法形成。例如，具有倒钩的轴对称多固定机构可通过激光、线EDM或化学蚀刻从金属薄片切割。金属部件还可使用金属注射成型技术制造。一些边缘可通过电抛光或或翻滚技术圆角化或锐化。塑料部件也可从薄片切割或注射成型。
倒钩207可形成在每一个单独的钩的任何表面上或表面组合上，但是最容易的两个面应是面向里朝向起搏器的表面，和面向外朝向组织的表面。将倒钩仅设置在面向里表面上具有实现抗旋开设计目的，同时保持面向外表面光滑，降低传递、再定位或取回过程中挂破或撕裂组织或倒钩保护套管的优点。
钩或倒钩的机械特性可通过选择钩材料和横截面外形改变。其可设计成通过增大其轴向厚度（增大切割其的薄片的厚度）具有轴向硬度，同时设计成通过降低其切割外形的柱宽度具有径向柔软性。钩可由塑料或金属制出。其可通过使用玻璃填充聚合物或硬金属，例如MP35N、不锈钢或钛，变得刚硬。其还可通过由柔性聚合物或超弹性nitinol制造钩来设计具有弹性。而且，其可部分或全部由生物可吸收聚合物制出，以使其提供可靠的急性固定，但是允许更容易地慢性取回。固定钩可制成多孔的，或使用高微观表面积涂层涂覆来促进慢性组织内生长和/或附着。钩还可使用类似于用于电极的类固醇涂覆，以降低最终的纤维化响应。
钩的角度也可调节来适应固定性能。当起搏器被设置在心室顶点处，并且旋转来接合组织时，钩的角度可确定当钩沿着其轨迹进入心脏组织中时，起搏器是否被沿远侧或近侧方向拉动或推动。如果钩向下倾斜（以使钩的尖锐的端头比钩的基部更远时），则起搏器将在起搏器旋转时沿远侧方向移动。该起搏器的附加的远侧运动可确保其远侧电极被拉动更靠近远侧心脏内可刺激组织，并且将保持与该组织接触。
该配置允许传统的固醇类心脏内起搏电极沿中心轴设置在远端头处。该电极可用作主起搏/感测端头电极，设置在距离本发明的固定机构几毫米处。
对于本发明的相关的另外的详细内容，可采用相关技术领域内的技术人员水平所知的材料和制造技术。关于本发明的基于方法的方面，也可根据通常或逻辑上采用的另外的行动也是可行的。而且，可预期的，可提出并且独立地要求保护所述的本发明的变形形式的任何可任选的特征或本文所述的特征中的任一个或多个的组合。同样，提到单数物件包括可能存在多个相同的物件。更具体地，如本文及所附权利要求中所用，单数形式“一个”和“所述”以及“该”包括复数形式，除非文中清楚另外说明。还应注意，权利要求可撰写以排除任何可任选元件。这样，该说明旨在用作与权利要求元件的引用一起使用这样的排除性术语，例如“唯一”、“仅”等，或使用“否定”限定的前提基础。除非本文中另外限定，本文中使用的全部技术和科技术语都具有与本发明所述领域的普通技术人员通常理解的相同的意思。本发明的范围不由本说明书限定，而是仅由采用的权利要求术语的普通意思限定。

Claims (25)

1.一种无导线心脏起搏器，包括：
密封壳体；
起搏电极，布置在壳体的远侧部分上；
电子封装部，布置在壳体中，该电子封装部配置为产生起搏信号并将该起搏信号传递到起搏电极；和
固定机构，与起搏电极分开，并且布置在壳体的远侧部分上，该固定机构具有小于或等于密封壳体外直径的直径，并且包括从固定机构的远端到固定机构的近端小于两个旋转圈。
2.根据权利要求1所述的起搏器，其中，固定机构包括从固定机构的远端到固定机构的近端小于一个半旋转圈。
3.根据权利要求1所述的起搏器，其中，固定机构包括从固定机构的远端到固定机构的近端小于一又四分之一个旋转圈。
4.根据权利要求1所述的起搏器，其中，起搏电极包括圆顶形状。
5.根据权利要求1所述的起搏器，其中，起搏电极被通过柔质弹簧附接到壳体，以减小抵靠心脏组织的压缩力。
6.根据权利要求1所述的起搏器，其中，起搏电极被通过硅粘合剂附接到壳体，以减小抵靠心脏组织的压缩力。
7.根据权利要求1所述的起搏器，其中，固定机构包括螺旋件。
8.根据权利要求7所述的起搏器，其中，螺旋件旋转小于或等于450度。
9.根据权利要求7所述的起搏器，其中，螺旋件至少部分地围绕起搏电极。
10.根据权利要求1所述的起搏器，其中固定机构包括恒定的直径。
11.根据权利要求1所述的起搏器，其中固定机构具有2.5mm至5mm的直径。
12.根据权利要求1所述的起搏器，其中固定机构包括小于1.8mm的纵向长度。
13.根据权利要求1所述的起搏器，其中壳体的远侧部分具有小于密封壳体外直径的外直径。
14.根据权利要求1所述的起搏器，其中固定机构尺寸确定和配置为使得，该固定机构在完全旋入心脏组织中时不引起患者的心肌穿孔。
15.根据权利要求1所述的起搏器，其中，固定机构包括径向部分和连接部分，该径向部分基本上与壳体的圆周对准，该连接部分将固定机构附接到壳体。
16.根据权利要求15所述的起搏器，其中，径向部分基本上垂直于连接部分。
17.根据权利要求15所述的起搏器，其中，连接部分具有小于患者心脏的心肌层厚度的长度。
18.根据权利要求15所述的起搏器，其中连接部分具有小于或等于1.8mm的长度。
19.根据权利要求15所述的起搏器，其中，固定机构的径向部分配置为位于患者的心脏的心肌层内，并且基本上与患者心脏的心脏内膜层接触。
20.根据权利要求15所述的起搏器，进一步包括倒钩，所述倒钩布置在固定机构的径向部分的内表面上。
21.根据权利要求1所述的起搏器，进一步配置为在收回过程中接收保护套管，所述保护套管具有与密封壳体的外直径类似的内直径。
22.一种将起搏器固定到患者心脏中的组织的方法，包括：
将起搏器的固定机构与心脏的心脏内膜相邻定位，所述固定机构具有小于或等于起搏器外直径的直径；
用固定机构刺入心脏内膜；和
使固定机构旋转小于一又四分之一圈，以基本上将固定机构全部插入心脏的心肌中，并且将起搏器的起搏电极放置为与心脏组织接触。
23.根据权利要求22所述的方法，其中固定机构包括螺旋件。
24.根据权利要求22所述的方法，其中，起搏器包括无导线心脏起搏器。
25.根据权利要求22所述的方法，进一步包括使用保护套管覆盖起搏器和固定机构，并且将起搏器从患者移除。
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