CN113597325A - 用于vfa心脏疗法的递送系统 - Google Patents

用于vfa心脏疗法的递送系统 Download PDF

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CN113597325A
CN113597325A CN202080022214.2A CN202080022214A CN113597325A CN 113597325 A CN113597325 A CN 113597325A CN 202080022214 A CN202080022214 A CN 202080022214A CN 113597325 A CN113597325 A CN 113597325A
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lumen
electrode
distal
heart
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A·J·阿斯勒森
杨中平
R·N·克莱弗
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Medtronic 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
    • A61N1/362—Heart stimulators
    • 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
    • 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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6851—Guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters
    • A61B5/6853—Catheters with a balloon
    • 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
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M25/0071—Multiple separate lumens
    • 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
    • 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
    • A61M2210/00—Anatomical parts of the body
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    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
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    • 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
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
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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
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    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
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    • A61N1/372—Arrangements in connection with the implantation of stimulators
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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
    • A61N2001/0585—Coronary sinus electrodes

Abstract

一种植入式医疗装置递送系统包含递送导管，所述递送导管包含细长主体，所述细长主体具有限定第一内腔的第一部分和限定第二内腔的第二部分。在分别由所述第一部分和所述第二部分限定的第一轴线与第二轴线之间限定有一定角度。当所述第一轴线指向CS时，所述第二轴线指向患者的心脏的左心室(LV)心尖。所述第一部分或细长元件可以延伸到CS中，以相对于CS的朝向锚定所述递送导管。

Description

用于VFA心脏疗法的递送系统
本公开涉及植入式医疗装置、系统和方法。具体地，本公开涉及用于心脏疗法的植入式医疗装置、系统和方法的递送，所述心脏疗法包含单腔或多腔起搏(例如，双腔或三腔起搏)、房室同步起搏、异步起搏、触发型起搏、心脏再同步化起搏或心动过速相关疗法。
心脏传导系统包含窦房(SA)结、房室(AV)结、希氏束(the bundle of His)、束支和浦肯野纤维(Purkinje fiber)。心跳在可以被描述为心脏的自然“起搏器”的SA结中启动。由SA结引起的电脉冲使心房心肌收缩。信号通过AV结传导到心室，所述AV结固有地延迟传导，以允许心房在心室开始收缩之前停止收缩，从而提供恰当的AV同步。电脉冲通过希氏束、束支和浦肯野纤维从AV结传导到心室心肌。
传导系统异常，如AV结传导不良或SA结功能不良的患者可以接受用于恢复更正常的心脏节律和AV同步的植入式医疗装置(IMD)，如起搏器。一些类型的IMD，如心脏起搏器、植入式心脏复律除颤器(ICD)或心脏再同步化疗法(CRT)装置通过定位于心脏中或被定位成与心脏相邻的一个或多个植入式心内膜、心外膜或冠状静脉引线上的电极向患者的心脏提供治疗性电刺激。治疗性电刺激可以以脉冲或电击形式递送到心脏，以用于起搏、心脏复律或除颤。在一些情况下，IMD可以感测到心脏的固有去极化，并且基于所述感测来控制向心脏递送治疗性刺激。
向心脏递送治疗性电刺激可以用于解决心脏病状，如可能发生在患者体内的心室不同步。心室不同步可以被描述为缺乏同步或心脏的心室之间的收缩定时的差异。收缩定时的显著差异可能降低心脏效率。由IMD递送到心脏的CRT可以通过使心脏的心室的机电活动再同步来增强心脏输出。由于CRT可以向右心房、右心室和左心室递送起搏，因此CRT有时被称为“三腔起搏”。
除了心脏起搏之外，还可以通过递送来自例如ICD的用于进行心脏复律或除颤的电击疗法来治疗心脏心律失常，所述ICD可以感测患者的心脏节律并且根据心律失常检测方案对节律进行分类，以便检测心动过速或纤颤发作。检测到的心律失常可以包含心室心动过速(VT)、快速心室心动过速(FVT)、心室纤颤(VF)、心房心动过速(AT)和心房纤颤(AT)。抗心动过速起搏(ATP)(无痛疗法)可以用于治疗心室心动过速(VT)，从而基本上终止许多单形快速节律。尽管ATP无痛，但ATP可能无法向所有类型的VT递送有效疗法。例如，ATP对于具有可变形态的多形VT可能不那么有效。多形VT和心室纤颤(VF)可能更致命，并且可能需要通过电击进行迅速治疗。
可获得双腔医疗装置，其包含可以放置在右心房中的经静脉心房引线携带的电极和可以通过右心房放置在右心室中的经静脉心室引线携带的电极。此类双腔医疗装置通常植入皮下袋中，并且经静脉引线隧穿到皮下袋。进一步地，此类双腔医疗装置可以感测心房电信号和心室电信号，并且可以根据需要提供心房起搏和心室起搏两者以促进正常心脏节律和AV同步。一些双腔医疗装置可以治疗心房心律失常和心室心律失常两者。
在一些患者中，单腔装置可以充分满足患者需求。然而，仅能够进行单腔感测和疗法的单腔装置可能无法完全解决所有患者(例如，患有一些形式的AV不同步或心动过速的患者)的心脏传导疾病或异常。除了在一些情况下的ICD功能之外，还可以使用双腔感测和/或起搏功能来恢复更正常的心脏节律。
发明内容
本公开的技术总体上涉及一种递送导管，所述递送导管将植入式医疗装置或引线引导到科赫三角(triangle of Koch)区域中的正确位置并且处于使用CS作为物理参考向LV递送起搏的朝向。
一方面，本公开提供了一种植入式医疗装置递送系统，其包含细长元件，所述细长元件能够锚定在患者的心脏的冠状窦(CS)中。所述系统还包含递送导管，所述递送导管具有细长主体，所述细长主体具有限定第一内腔的第一部分和限定第二内腔的第二部分。位于所述第一部分的第一远端区域中的所述第一内腔沿第一轴线延伸，并且位于所述第二部分的第二远端区域中的所述第二内腔沿与所述第一轴线形成一定角度的第二轴线延伸。当可锚定的细长元件推进穿过所述第一内腔进入CS中时，所述第二轴线指向患者的心脏的左心室(LV)心尖。
另一方面，本公开提供了一种递送导管，其包含可推进到患者的心脏的冠状窦(CS)中的第一部分，所述第一部分具有限定第一内腔和外部通道的细长主体。当所述第一部分被推进到CS中时，所述第一部分的与患者的心脏的CS口相邻的区域沿第一轴线延伸。所述装置包含第二部分，所述第二部分具有限定第二内腔的细长主体并且具有侧向延伸的凸出部，所述侧向延伸的凸出部被配置成收纳在所述第一部分的外部通道中，以便沿所述第一部分的长度可滑动地引导所述第二部分。当所述凸出部接合在通道中时，第二部分的远端区域沿与第一轴线形成固定角度的第二轴线延伸，使得当第一部分被推进到CS中时，所述第二轴线指向患者的心脏的左心室(LV)心尖。
在又另一方面，本公开提供了一种递送植入式医疗装置的方法，所述方法包含使双内腔导管的第一部分的第一远端区域朝患者的心脏的冠状窦(CS)推进。所述第一部分限定第一内腔，并且所述第一远端区域沿第一轴线延伸。所述方法包含使双内腔导管的第二部分的第二远端区域朝患者的心脏的科赫三角区域定向。所述第二部分限定第二内腔，并且所述第二远端区域沿与所述第一轴线形成一定角度的第二轴线延伸，使得使得当所述第一远端区域完全朝CS推进时，所述第二轴线指向所述患者的心脏的左心室(LV)心尖。
本公开的一个或多个方面的细节在附图和以下描述中阐述。本公开中描述的技术的其它特征、目的和优点将根据说明书和附图并且根据权利要求书而显而易见。
附图说明
图1是心脏疗法系统的实例的概念图，所述心脏疗法系统包含以横截面视图示出的用于将植入式医疗装置植入患者的心脏中的递送系统以及定位在患者的心脏外部的单独的医疗装置。
图2是可以用图1的递送系统递送的心脏内医疗装置的实例以及患者的心脏的解剖结构的概念图。
图3是可以用图1的递送系统递送的心脏内医疗装置的另一个实例的透视图。
图4是示出了用于与例如图1-3的示例性系统一起使用的各种电极植入位置的左心室的标准的17段视图中的患者的心脏的绘图的概念图。
图5A-C是图1的递送系统的一个实例的概念图。
图6是图1的递送系统的另一个实例的概念图。
图7是使用图1的递送系统的方法的一个实例的流程图。
图8是执行或实施图7的方法的一个实例的流程图。
图9是执行或实施图7的方法的另一个实例的流程图。
图10是执行或实施图7的方法的又另一个实例的流程图。
具体实施方式
本公开涉及用于心房到心室(VfA)心脏疗法的植入式医疗装置、系统和方法的递送，所述心脏疗法包含单腔或多腔起搏(例如，双腔或三腔起搏)、房室同步起搏、异步起搏、触发型起搏、心脏再同步化起搏或心动过速相关疗法。尽管本文中参考了如起搏器或ICD等植入式医疗装置(IMD)，但是所述方法和工艺可以与和患者的心脏有关的任何医疗装置、系统或方法一起使用。各种其它应用对于受益于本公开的本领域的技术人员将变得显而易见。
用于将VfA装置或引线定位在正确的植入位置和朝向中或定位在正确的植入位置和朝向处以瞄准正确的方向来刺激LV心内膜组织的程序可能很困难。对于这种VfA装置放置，至少要考虑两个因素。首先，递送导管的导管尖端将引导到位于CS口与三尖瓣环之间的科赫三角，所述科赫三角是光滑的位置，在所述位置中，由于场所的不稳定性，可能难以保持导管的放置。其次，一旦导管就位，装置必须被定向成在正确的组织平面中，以将电极定位在LV组织中用于起搏。
本公开提供了一种递送导管，所述递送导管可以被描述为双内腔或两内腔导管，其可以在目标植入区域处产生稳定性并且还可以提供进入组织的正确角度以用于提供VfA心脏疗法。具体地，递送导管的实例可以将植入式医疗装置或引线引导到科赫三角区域中的正确位置并且处于使用CS作为物理参考向LV递送起搏的朝向。例如，递送导管的一部分或延伸穿过所述部分进入CS中的细长元件可以基于CS的朝向锚定递送导管。在一个实施例中，递送导管的一个内腔可以用于将细长构件跟踪或引导到CS中，并且递送导管的另一个内腔可以在远端区域附近具有弯曲部，以使由此递送的装置以正确朝向成角度地进入组织中。内腔可以被描述为并排定位。
现在将参考描绘了本公开中描述的一个或多个方面的附图。然而，应当理解，附图中未描绘的其它方面落入本公开的范围内。附图中使用的相同标记指代相同的组件、步骤等。然而，应当理解，在给定附图中使用附图标记来指代元件并不旨在限制另一附图中以同一附图标记标记的元件。另外，使用不同的附图标记来指代不同附图中的元件并不旨在指示不同参考的元件不能相同或相似。
尽管本公开描述了无引线和有引线的植入式医疗装置，但首先参考图1，其示出了包含也可以被描述为植入式医疗引线的带引线的医疗装置104的心脏疗法系统2的概念图，所述心脏疗法系统可以被配置成用于单腔或双腔疗法并且植入在患者的心脏8中。在一些实施例中，装置104可以被配置成用于单腔起搏，并且可以例如在单腔与多腔起搏(例如，双腔或三腔起搏)之间进行切换。
装置104被示出为植入在患者的心脏8的右心房(RA)中的目标植入区域4中。装置104可以包含一个或多个固定构件(如图2中的固定构件20)，所述一个或多个固定构件将装置的远端锚定在目标植入区域4中的心房心内膜上。目标植入区域4可以位于希氏束5与冠状窦3之间，并且可以与三尖瓣6相邻。装置104可以被描述为心房到心室(VfA)装置，其可以在通常被安置在右心房中的同时感测一个或两个心室(例如，右心室、左心室或两个心室，视情况而定)或向其提供疗法。具体地，装置104可以包含组织刺穿电极，所述组织刺穿电极可以从右心房的科赫三角区域通过右心房心内膜和中心纤维体植入患者的心脏的左心室心肌的高基底区和/或隔区中。
将装置104以期望的朝向有效递送到目标植入区域4中的精确位置可能是具有挑战性的。递送导管100可以提供对CS的稳定锚定，以促进向目标植入区域4递送装置104。可以通过使用延伸穿过递送导管100的细长元件102来促进稳定锚定。在一些实施例中，递送导管100可以被描述为双内腔导管。双内腔导管可以包含限定第一内腔的第一部分101和限定第二内腔的第二部分103，其可以由单件材料整体形成或单独形成。第一部分101可以延伸到CS中，或者第一部分的第一内腔可以用于将细长元件102递送到CS中以用于锚定。第二内腔可以用于将植入式医疗装置104或引线递送到科赫三角以便进行植入。双内腔导管可以被描述为预成形的或被配置成在第一内腔与第二内腔之间，例如至少在其远端区域处提供固定或可偏转的角度。当使用延伸到CS中的细长元件102将第一内腔与冠状窦的朝向对准时，第二内腔可以以一定角度定向并对准科赫三角区域，所述角度将装置104的组织刺穿电极从RA的科赫三角区域穿过RA心内膜和中心纤维体植入到LV心肌的高基底区和/或隔区中。递送导管100可以在递送装置104之后取出。
装置104可以包含一个或多个镖电极12，其具有直轴，所述直轴从装置104的远端区域延伸穿过心房心肌和中心纤维体并且进入心室心肌14或沿心室隔膜，而不完全穿透心室心内膜或心外膜表面。换言之，一个或多个镖电极12可能不会刺穿心室壁进入血容量中。一个或多个镖电极12可以各自承载在轴的远端区域处的一个或多个电极元件，用于将所述一个或多个电极元件定位在心室心肌内以感测心室信号并递送心室脉冲(例如，使左心室去极化以引起左心室的收缩)。在一些实例中，在轴的远端区域处的电极元件可以包含被提供用于在用于起搏和感测的双极电极对中使用的阴极电极。尽管图1中示出了植入区域4以使得一个或多个镖电极12的一个或多个电极能够定位在心室心肌中，但是应当认识到，具有本文公开的方面的装置可以植入在其它位置处以进行多腔起搏(例如，双腔或三腔起搏)、具有多腔感测的单腔起搏、单腔起搏和/或感测，或其它临床疗法和应用，视情况而定。
心脏疗法系统2还可以包含单独的医疗装置50(在图1中示意性地描绘)，所述单独的医疗装置可以定位在患者的心脏8的外部(例如，皮下)并且可以可操作地耦接到患者的心脏8以向其递送心脏疗法。在一个实例中，单独的医疗装置50可以是血管外ICD。在一些实施例中，血管外ICD可以包含带有除颤电极的除颤引线。疗法向量可以存在于除颤引线上的除颤电极与ICD的壳体电极之间。进一步地，ICD的一个或多个电极还可以用于感测与患者的心脏8有关的电信号。ICD可以被配置成递送包含一种或多种除颤或心脏复律电击的电击疗法。例如，如果感测到心律失常，则ICD可以通过电引线发送脉冲，以电击心脏并且恢复其正常节律。在一些实例中，ICD可以递送电击疗法而无需将电引线放置在心脏内或将电线直接附接到心脏(皮下ICD)。可以与本文所述的系统2一起使用的血管外、皮下ICD的实例可以在发布于2016年3月8日的美国专利第9,278,229号(Reinke等人)中进行描述。
装置104和单独的医疗装置50可以协作以向患者的心脏8提供心脏疗法。例如，装置104和单独的医疗装置50可以用于检测心动过速、监测心动过速和/或提供心动过速相关疗法。例如，装置104可以与单独的医疗装置50进行无线通信，以使用单独的医疗装置50来触发电击疗法。如本文所使用的，“无线”是指在不使用连接装置104和单独的医疗装置50的金属导体的情况下的操作性耦接或连接。在一个实例中，无线通信可以使用由装置104提供的传导穿过患者的组织并且可由单独的医疗装置50检测到的独特的、信号传导的或触发的电脉冲。在另一个实例中，无线通信可以使用装置104的通信接口(例如，天线)来提供电磁辐射，所述电磁辐射传播穿过患者的组织并且可例如使用单独的医疗装置50的通信接口(例如，天线)检测到。
图2是无引线植入式医疗装置106或心脏内医疗装置以及患者的心脏8的解剖结构的概念图。关于装置106所描述的特征中的一个或多个特征也可以与如带引线的IMD 104(图1)等带引线的IMD一起使用。如本文所使用的，“心脏内”是指被配置成完全植入患者的心脏内，例如，以提供心脏疗法的装置。
心脏内装置10可以包含壳体30。壳体30可以限定装置106的内部组件，如感测电路、疗法递送电路、控制电路、存储器、遥测电路、其它任选的传感器和电源所驻留的气密密封内部空腔。壳体30可以由包含钛或钛合金、不锈钢、MP35N(非磁性镍-钴-铬-钼合金)、铂合金或其它生物相容性金属或金属合金的导电材料形成。在其它实例中，壳体30可以由包含陶瓷、玻璃、蓝宝石、硅酮、聚氨酯、环氧树脂、乙酰基共聚物塑料、聚醚醚酮(PEEK)、液晶聚合物或其它生物相容性聚合物的非导电材料形成。
装置106可以被描述为无引线植入式医疗装置。如本文所使用的，“无引线”是指没有从患者的心脏8延伸出来的引线的装置。换言之，无引线装置的引线可以不从患者的心脏的外部延伸到患者的心脏的内部。一些无引线装置可以穿过静脉引入，但是一旦被植入，所述装置就没有任何经静脉引线或可以不包含任何经静脉引线，并且可以被配置成在不使用任何经静脉引线的情况下提供心脏疗法。具体地，无引线VfA装置在装置的壳体定位在心房中时不使用引线来可操作地连接到心室中的电极。无引线电极可以耦接到医疗装置的壳体，而无需在电极与壳体之间使用引线。
壳体30可以被描述为在远端区域32与近端区域34之间以大致圆柱形形状延伸，以促进导管递送。在其它实施例中，壳体30可以是棱柱形或任何其它形状，以便执行本文所述的功能和效用。壳体30可以包含例如位于近端34处的用于在装置106的植入期间与递送工具接合的递送工具接口构件26。例如，可以使用递送导管100(图1)使装置106朝目标植入区域4推进时使用递送工具接口构件26。
壳体30的全部或一部分可以在心脏疗法期间例如在感测和/或起搏中用作电极。在所示出的实例中，基于壳体的电极24被示出为外接壳体30的近侧部分。当壳体30包含如钛合金或以上所列出的其它实例等导电材料(例如，由导电材料形成)时，壳体30的部分可以通过如聚对二甲苯、聚氨酯、硅酮、环氧树脂或其它生物相容性聚合物的涂层等非导电材料进行电绝缘，从而使导电材料的一个或多个离散区域暴露出来以限定近侧基于壳体的电极24。当壳体30包含如陶瓷、玻璃或聚合物材料等非导电材料(例如，由非导电材料形成)时，可以将如钛、铂、不锈钢或其合金等导电涂层或层施加到壳体30的一个或多个离散区域，以形成近侧基于壳体的电极24。在其它实例中，近侧基于壳体的电极24可以是安装或组装到壳体30上的组件，如环形电极。近侧基于壳体的电极24可以例如通过导电壳体30或电导体在壳体30包含非导电材料时电耦接到装置106的内部电路系统。
在所示出的实例中，基于壳体的电极24可以被定位成与壳体远端区域32相比，更靠近壳体近端区域34，并且因此可以被描述为近侧基于壳体的电极。然而，在其它实例中，基于壳体的电极24可以位于沿壳体30的其它定位处，例如，比图2中所示的定位相对更远。
在远端区域32处，装置106可以包含远侧固定和电极组合件36，除了长度相等或不相等的一个或多个镖电极12之外，所述远侧固定和电极组合件可以包含一个或多个固定构件20。如所描绘的装置106包含单个镖电极12，所述单个镖电极可以包含远离壳体远端区域32向远侧延伸的轴40，并且可以包含在轴40的自由远端区域处或附近的一个或多个电极元件，如尖端电极元件42。尖端电极元件42可以具有圆锥形或半球形远侧尖端，所述远侧尖端具有相对窄的尖端直径(例如，小于约1毫米(mm))，其用于穿入并且穿过组织层，而无需使用具有尖锐或斜切边缘的尖锐尖端或针状尖端。
镖电极12的轴40正常可以是笔直的构件并且可以是刚性的。在其它实施例中，轴40可以被描述为是相对坚硬的，但在侧向方向上仍具有有限的柔性(例如，弹性的或半刚性的)。进一步地，轴40可以是非刚性的，以允许随着心脏运动而发生一些侧向挠曲。然而，在松弛状态下，当未经受任何外力时，轴40可以维持如所示的笔直定位，以保持尖端电极元件42与壳体远端区域32间隔开至少轴40的长度或高度47。镖电极12可以被配置成刺穿一个或多个组织层，以将尖端电极元件42定位在期望的组织层，例如心室心肌内。如此，轴40的长度或高度47可以与预期的起搏部位深度相对应，并且轴可以沿其纵向轴线具有相对高的压缩强度，以在被压靠在植入区域4时抵抗侧向或径向方向上的弯曲。如果采用第二镖电极12，则其长度或高度可以不等于预期的起搏部位深度，并且可以被配置成充当用于向组织递送起搏能量的无关电极。可以例如通过向壳体30的近端34施加纵向“推”力来对尖端电极元件42施加纵向轴向力，以使镖电极12推进到目标植入区域4内的组织中。轴40可以是纵向非压缩的。进一步地，轴40在经受侧向或径向力时可以在侧向或径向方向上是可弹性变形的，以允许例如随着组织运动而暂时挠曲，但是当侧向力减小时可以返回到其正常笔直的定位。当轴40未暴露于任何外力或仅暴露于沿其纵向中心轴线的力时，轴40可以保持如所示的笔直的线性定位。
一个或多个固定构件20可以被描述为具有正常弯曲定位的一个或多个“尖齿”。尖齿可以被保持在递送工具内的向远侧延伸的定位中。尖齿的远侧尖端可以穿透心脏组织至有限深度，然后其一从递送工具释放，就向近侧弹性地弯曲回到(所示)正常弯曲定位。进一步地，固定构件20可以包含在例如发布于2017年6月13日的美国专利第9,675,579号(Grubac等人)和发布于2015年9月1日的美国专利第9,119,959号(Rys等人)中描述的一个或多个方面。
在一些实例中，远侧固定和电极组合件36包含远侧基于壳体的电极22。在使用装置106作为起搏器进行多腔起搏(例如，双腔或三腔起搏)和感测的情况下，尖端电极元件42可以用作与充当返回阳极电极的近侧基于壳体的电极24配对的阴极电极。可替代地，远侧基于壳体的电极22可以充当与用于感测心室信号并且递送心室起搏脉冲的尖端电极元件42配对的返回阳极电极。在其它实例中，远侧基于壳体的电极22可以是用于感测心房信号并且向目标植入区域4中的心房心肌递送起搏脉冲的阴极电极。当远侧基于壳体的电极22充当心房阴极电极时，近侧基于壳体的电极24可以充当与用于心室起搏和感测的尖端电极元件42配对的返回阳极，并且可以充当与用于心房起搏和感测的远侧基于壳体的电极22配对的返回阳极。
如此图示中所示，在一些起搏应用中，目标植入区域4沿心房心内膜18，通常在AV结15和希氏束5下部。镖电极42可以限定轴40的长度或高度47，以穿透目标植入区域4中的心房心内膜18、穿过中心纤维体16并且进入心室心肌14而不穿透心室心内膜表面17。当镖电极12的长度或高度47完全推进到目标植入区域4中时，尖端电极元件42可以搁置或定位在心室心肌14内，并且远侧基于壳体的电极22可以被定位成与心房心内膜18紧密接触或极为接近。在各个实例中，镖电极12的尖端电极元件42和轴40的总组合长度或高度47可以为约3mm到约8mm。轴40的直径可以小于约2mm，并且可以为约1mm或更小，或甚至约0.6mm或更小。
装置106可以包含壳体30内的运动检测器11。运动检测器11可以用于监测机械活动，如心房机械活动(例如，心房收缩)和/或心室机械活动(例如，心室收缩)。在一些实施例中，运动检测器11可以用于检测右心房机械活动。运动检测器11的非限制性实例包含加速度计。在一些实施例中，由运动检测器11检测到的机械活动可以用于补充或替换由装置106的电极中的一个或多个电极检测到的电活动。例如，除了近侧基于壳体的电极24之外或作为所述近侧基于壳体的电极的替代方案之外，可以使用运动检测器11。
运动检测器11还可以用于速率响应检测或提供速率响应性IMD。与速率响应有关的各种技术可以在发布于1992年10月13日的题为“速率响应性心脏起搏器的优化(Optimization for rate responsive cardiac pacemaker)”的美国专利第5,154,170号(Bennett等人)以及发布于1996年10月8日的题为“用于速率响应性心脏起搏的方法和设备(Method and apparatus for rate-responsive cardiac pacing)”的美国专利第5,562,111号(Yerich等人)中进行描述。
图3是可以被配置成用于单腔或多腔心脏疗法(例如，双腔或三腔心脏疗法)的无引线植入式医疗装置110或心脏内医疗装置的另一个实例的三维透视图。关于装置110所描述的特征中的一个或多个特征也可以与如带引线的IMD 104(图1)等带引线的IMD一起使用。
装置110可以包含壳体130，所述壳体具有或限定从壳体远端区域132延伸到壳体近端区域134的示出为圆柱形外侧壁的外侧壁135。壳体130可以封闭被配置成执行单腔或多腔心脏疗法的电子电路系统，所述单腔或多腔心脏疗法包含心房和心室心脏电信号感测和对心房腔和心室腔进行起搏。递送工具接口构件126被示出为在壳体近端区域134上。
远侧固定和电极组合件136可以耦接到壳体远端区域132。远侧固定和电极组合件136可以包含耦接到壳体远端区域132的电绝缘远侧构件172。组织刺穿电极112远离壳体远端区域132延伸，并且多个非组织刺穿电极122可以直接耦接到绝缘远侧构件172。组织刺穿电极112在远离壳体远端区域132的纵向方向上延伸，并且可以与壳体130的纵向中心轴线131同轴。
组织刺穿远侧电极112可以包含电绝缘轴140和尖端电极元件142。在一些实例中，组织刺穿远侧电极112还用作固定构件，并且可以包含螺旋轴140和远侧阴极尖端电极元件142。螺旋轴140可以从轴远端区域143延伸到轴近端区域141，所述轴近端区域可以直接耦接到绝缘远侧构件172。螺旋轴140可以用电绝缘材料涂覆，例如聚对二甲苯或本文列出的其它实例，以避免沿轴长度感测或刺激心脏组织。尖端电极元件142处于轴远端区域143处，并且可以充当阴极电极，所述阴极电极用于在尖端电极元件142推进到心室组织中时使用近侧基于壳体的电极124作为返回阳极来递送心室起搏脉冲并感测心室电信号。近侧基于壳体的电极124可以是外接壳体130的环形电极，并且可以由纵向侧壁135的未绝缘部分限定。壳体130的不充当电极的其它部分可以用如上文结合图2所描述的电绝缘材料涂覆。
使用穿入LV心肌中的两个或更多个组织刺穿电极(例如，任何类型的组织刺穿电极)可以用于局部起搏捕获，并且可以减轻心室起搏尖峰，从而影响捕获心房组织。在一些实施例中，多个组织刺穿电极可以包含镖型电极(例如，图1-2的电极12)和螺旋型电极(例如，电极112)中的两个或更多个。多个组织刺穿电极的非限制性实例包含两个镖电极、具有延伸穿过其中(例如，穿过中心)的镖电极的螺旋电极或双缠结螺旋。多个组织刺穿电极还可以用于双极或多极起搏。
在一些实施例中，穿入LV心肌中的一个或多个组织刺穿电极(例如，任何类型的组织刺穿电极)可以是多极组织刺穿电极。多极组织刺穿电极可以包含一个或多个电活性元件和电分离元件，其可以使得能够从一个或多个组织刺穿电极进行双极或多极起搏。
多个非组织刺穿电极122可以沿绝缘远侧构件172的周边设置(例如，设置在组织刺穿电极112的周边。绝缘远侧构件172可以限定装置110的面向远侧的表面138和外接与壳体纵向侧壁135相邻的装置110的周向表面139。非组织刺穿电极122可以由如钛、铂、铱或其合金等导电材料形成。在所展示的实施例中，六个非组织刺穿电极122沿绝缘远侧构件172的外周以相等距离径向间隔开。然而，在一些实施例中，可以提供两个或更多个非组织刺穿电极122。
非组织刺穿电极122可以是离散组件，所述离散组件各自保持在绝缘构件172中的相应凹部174内，所述凹部的大小和形状被设定成与非组织刺穿电极122配合。在其它实例中，非组织刺穿电极122可以各自是安装在绝缘远侧构件172内或其上的单件式构件的未绝缘暴露部分。单件式构件中的不用作电极的中间部分可以通过绝缘远侧构件172进行绝缘，或者如果所述中间部分暴露于周围环境中，则可以涂覆有电绝缘涂层，例如聚对二甲苯、聚氨酯、硅酮、环氧树脂或其它绝缘涂层。
当组织刺穿电极112推进到心脏组织中时，至少一个非组织刺穿电极122可以被定位成抵靠心脏组织表面、与心脏组织表面紧密接触或在操作上接近心脏组织表面，以递送脉冲和/或感测由患者的心脏产生的心脏电信号。例如，当组织刺穿电极112推进到心房组织中并且穿过中心纤维体直到远侧尖端电极元件142被定位成与心室组织，例如心室心肌和/或心室传导系统的一部分直接接触时，一个或多个非组织刺穿电极122可以被定位成与右心房心内膜组织接触以在心房中进行起搏和感测。
非组织刺穿电极122可以耦接到由壳体130封闭的疗法递送电路和感测电路，以与作为返回阳极的近侧基于壳体的电极124结合共同用作用于递送心房起搏脉冲并感测心房电信号(例如，P波)的阴极电极。可以在控制电路的控制下激活包含在感测电路中的开关电路系统，以将非组织刺穿电极中的一个或多个耦接到心房感测通道。远侧非组织刺穿电极122可以彼此电隔离，使得可以通过包含在疗法递送电路中的开关电路系统来分别选择电极122中的每个单独的电极，以单独地或与电极122中的两个或更多个组合充当心房阴极电极。可以在控制电路的控制下激活包含在疗法递送电路中的开关电路系统，以将非组织刺穿电极122中的一个或多个耦接到心房起搏电路。可以一次选择非组织刺穿电极122中的两个或更多个以用作多点心房阴极电极。
可以基于心房捕获阈值测试、电极阻抗、心脏电信号中的P波信号强度或其它因素来选择被选择用于心房起搏和/或心房感测的某些非组织刺穿电极122。例如，可以选择用作提供低起搏捕获阈值幅度和相对高的电极阻抗的最佳组合的阴极电极的单个非组织刺穿电极122或两个或更多个单独的所述非组织刺穿电极的任何组合，以使用来自电源的最小电流消耗来实现可靠的心房起搏。
在一些情况下，当组织刺穿电极112将壳体130锚定在植入部位时，面向远侧的表面138可以均匀地接触心房心内膜表面。在所述情况下，可以一起选择所有电极122以形成心房阴极。可替代地，电极122中的每隔一个电极可以被一起选择以形成具有较高电阻抗的多点心房阴极，所述多点心房阴极仍沿面向远侧的表面138均匀地分布。可替代地，沿绝缘远侧构件172的一侧的一个或多个电极122的子集可以被选择成在期望的部位处提供起搏，所述期望的部位由于电极122对受到起搏的心房组织的相对位置而实现最低的起搏捕获阈值。
在其它情况下，根据组织刺穿电极112进入心脏组织的定位和朝向，面向远侧的表面138可以相对于相邻的心内膜表面以一定角度定向。在这种情形下，非组织刺穿电极122中的一个或多个可以被定位成与其它非组织刺穿电极122相比与相邻的心内膜组织更紧密地接触，所述其它非组织刺穿电极可以成角度地远离心内膜表面。通过沿绝缘远侧构件172的周边提供多个非组织刺穿电极，组织刺穿电极112和壳体远端区域132相对于心脏表面，例如右心房心内膜表面的角度可能不需要基本上平行。解剖差异和定位差异可能使面向远侧的表面138相对于心内膜表面成角度或倾斜，然而，沿绝缘远侧构件172的周边分布的多个非组织刺穿电极122可以增加一个或多个电极122与相邻心脏组织之间进行“良好”接触的可能性，以使用多个电极122的至少一个子集来促进可接受的起搏阈值和可靠的心脏事件感测。可能不需要周向地沿绝缘远侧构件172的整个周边接触或固定。
非组织刺穿电极122被示出为各自包含沿面向远侧的表面138延伸的第一部分122a和沿周向表面139延伸的第二部分122b。第一部分122a和第二部分122b可以是连续的暴露表面，使得有源电极表面包绕绝缘远侧构件172的接合面向远侧的表面138和周向表面139的周边边缘176。非组织刺穿电极122可以包含沿面向远侧的表面138的电极中的一个或多个电极、沿周向表面139的一个或多个电极、各自沿面向远侧的表面138和周向表面139两者延伸的一个或多个电极或其任何组合。非组织刺穿电极122中的每个非组织刺穿电极的暴露表面可以与相应的面向远侧的表面138和/或周向表面齐平。在其它实例中，非组织刺穿电极122中的每个非组织刺穿电极可以具有从绝缘远侧构件172突出的凸起表面。然而，电极122的任何凸起表面可以限定光滑或圆形的非组织刺穿表面。
远侧固定和电极组合件136可以密封壳体130的远端区域，并且可以提供电极122安装在其上的基础。电极122可以被称为基于壳体的电极。电极122可以不由将有源电极部分延伸远离壳体130的轴或其它延伸部承载，如驻留在延伸远离壳体130的螺旋轴140的远侧尖端处的远侧尖端电极元件142。本文呈现的耦接到绝缘远侧构件的面向远侧的表面和/或周向表面的非组织刺穿电极的其它实例包含远侧基于壳体的环形电极22(图2)、围绕组合件36(图2)周向延伸的远侧基于壳体的环形电极、按钮电极、其它基于壳体的电极以及其它周向环形电极。可以提供直接耦接到远侧绝缘构件、周边地耦接到中心组织刺穿电极的任何非组织刺穿电极，以单独地、共同地或以任何组合的方式用作用于向相邻心脏组织递送起搏脉冲的阴极电极。当提供环形电极，如远侧环形电极22和/或周向环形电极时，环形电极的部分可以通过涂层进行电绝缘，以沿绝缘远侧构件的面向远侧的表面和/或周向表面提供多个分布式非组织刺穿电极。
与沿远侧固定和电极组合件136提供的组织刺穿电极相比，非组织刺穿电极122和以上所列出的其它实例预期提供更可靠和有效的心房起搏和感测。与心室腔壁相比，心房腔壁相对较薄。组织刺穿心房阴极电极可能会在心房组织内延伸得太深，导致无意间持续或间歇性捕获心室组织。由于在通过物理上更紧密接近心室组织的组织刺穿心房阴极电极接收到的心脏电信号中具有较大信号强度的心室信号，组织刺穿心房阴极电极可能导致对感测心房信号产生干扰。组织刺穿电极112可以牢固地锚定到心室组织中，以使装置110的植入定位稳定并且提供尖端电极元件142在心室组织中感测和起搏而非组织刺穿电极122在心房中可靠地起搏和感测的合理确定性。当装置110被植入目标植入区域4中时，例如如图1所示的心室隔膜，尖端电极元件142可以到达左心室组织以对左心室进行起搏，而非组织刺穿电极122在右心房中提供起搏和感测。组织刺穿电极112可以处于距面向远侧的表面138约4到约8mm的长度范围内以到达左心室组织。在一些情况下，装置110可以通过以下实现四腔起搏：通过目标植入区域4中的非组织刺穿电极122从心房起搏电路递送心房起搏脉冲以实现双心房(右心房和左心房)捕获，以及通过从目标植入区域4推进到心室组织中的尖端电极元件142从心室起搏电路递送心室起搏脉冲以实现双心室(右心室和左心室)捕获。
本文描述的组件，如控制器、电路系统、加速度计或传感器中的一个或多个可以包含处理器，如中央处理单元(CPU)、计算机、逻辑阵列或能够引导数据进入或离开医疗装置的其它装置。控制器可以包含具有存储器、处理和通信硬件的一个或多个计算装置或处理电路系统。控制器可以包含用于将控制器的各种组件耦接在一起或与可操作地耦接到控制器的其它组件耦接的电路系统。控制器的功能可以通过硬件和/或作为非暂时性计算机可读存储介质上的计算机指令来执行。
控制器的处理器可以包含以下中的任何一种或多种：微处理器、微控制器、数字信号处理器(DSP)、专用集成电路(ASIC)、现场可编程门阵列(FPGA)和/或等效离散或集成逻辑电路系统。在一些实例中，处理器可以包含多个组件，如一个或多个微处理器、一个或多个控制器、一个或多个DSP、一个或多个ASIC和/或一个或多个FPGA的任何组合，以及其它离散或集成逻辑电路系统。归属于本文的控制器或处理器的功能可以体现为软件、固件、硬件或其任何组合。尽管在本文中描述为基于处理器的系统，但替代性控制器可以单独地或与基于微处理器的系统组合地利用如继电器和定时器等其它组件来实现期望的结果。
在一个或多个实施例中，示例性系统、方法和其它功能可以使用可以包含一个或多个处理器和/或存储器的计算设备使用一个或多个计算机程序来实施。本文所述的程序代码和/或逻辑可以应用于输入数据/信息以执行本文所述的功能并且生成期望的输出数据/信息。可以将输出数据/信息作为输入应用于如本文所述的或将以已知方式应用的一个或多个其它装置和/或方法。鉴于上述，将易于显而易见的是，可以以本领域的技术人员已知的任何方式来实施如本文所述的控制器功能。
图4是患者的心脏的二维(2D)心室绘图60(例如，自顶向下视图)，其示出了呈标准的17段视图的左心室62和右心室64。绘图60包含与人类心脏的不同区域相对应的多个区域68。如图所展示的，区域68被数字标记为1-17(其例如与人类心脏的标准的17段模型相对应、与人类心脏的左心室的17段相对应等)。绘图60的区域68可以包含基底前区1、基底前隔区2、基底下隔区3、基底下区4、基底下侧区5、基底前侧区6、中前区7、中前隔区8、中下隔区9、中下区10、中下侧区11、中前侧区12、顶前区13、顶隔区14、顶下区15、顶侧区16和顶点区17。还展示了右心室64的下隔区和前隔区，以及右束支(RBB)和左束支(LBB)。
在一些实施例中，本公开的任何组织刺穿电极可以被植入在患者的心脏的左心室心肌的基底区和/或隔区中。具体地，组织刺穿电极可以从右心房的科赫三角区域穿过右心房心内膜和中心纤维体而植入。
一旦植入，组织刺穿电极就可以定位在目标植入区域4(图1)中，如左心室心肌的基底和/或隔区。参考绘图60，基底区域包含以下中的一个或多个：基底前区1、基底前隔区2、基底下隔区3、基底下区4、中前区7、中前隔区8、中下隔区9和中下区10。参考绘图60，隔区包含以下中的一个或多个：基底前隔区2、基底前隔区3、中前隔区8、中下隔区9和顶隔区14。
在一些实施例中，当植入时，组织刺穿电极可以定位于左心室心肌的基底隔区中。基底隔区可以包含基底前隔区2、基底下隔区3、中前隔区8和中下隔区9中的一个或多个。
在一些实施例中，当植入时，组织刺穿电极可以定位于左心室心肌的高下/后基底隔区中。左心室心肌的高下/后基底隔区可以包含基底下隔区3和中下隔区9中的至少一个的一部分。例如，高下/后基底隔区可以包含总体上展示为虚线边界的区域66。如图所示，虚线边界表示对高下/后基底隔区大约所在的位置的近似估计，并且根据具体应用可以采用稍微不同的形状或大小。在不受任何特定理论束缚的情况下，由于心内膜下浦肯野纤维与心室心肌之间的功能性电耦接，心室内同步起搏和/或激活可能是由刺激高隔心室心肌引起的。
图5A-C示出了可以与细长元件102一起使用的递送导管100(图1)的实施方案的一个实例的各种视图。图5A是示出了可以与细长元件102一起使用的递送导管200的侧视图。图5B是示出了递送导管200的俯视图。图5C是沿图5B中所示的线C-C截取的横截面视图。
细长元件102可以是用于插入到CS中的任何合适的装置。例如，细长元件102可以是导丝或导管。在一些实施例中，细长元件102可以是可操纵的。
进一步地，细长元件102可以锚定在CS中。可锚定在CS中意味着细长元件102包含用于将细长元件保持在CS内持续任何时间段的任何合适的机构。在一些实施例中，细长元件102可以包含可锚定的球囊或可锚定的侧螺旋，以促进在细长元件插入到CS中之后稳定锚定在CS中，这可以为向目标植入区域4(图1)递送装置提供可靠参考。细长元件102可以插入到CS中的任何合适的距离，以促进细长元件作为物理参考的使用。细长元件102可以保留在CS中或在将装置植入在目标植入区域4处之后取出。
除了提供对CS的物理参考之外，细长元件102还可以提供其它功能。在一些实施例中，细长元件102可以保留在CS中并且可以用作心脏疗法系统2(图1)的一部分。例如，细长元件102可以包含一个或多个电极，以促进心脏疗法。在一些实施例中，细长元件102可以被描述为用于感测或起搏的疗法导管，如电生理学(EP)导管。例如，EP导管可以用于评估心脏中的电模式并且然后进行消融。
递送导管200包含细长主体，所述细长主体包含第一部分202和第二部分204，其可以由单件材料整体形成或单独形成并且耦接在一起。第一部分202和第二部分204可以从近侧区域210延伸到相应的第一远端区域206和相应的第二远端区域208。如所展示的，近侧区域210可以表示递送导管200的近端区域或不是递送导管200的近端区域的中间区域。递送导管200可以是任何合适的长度，以促进本公开的技术。第一部分202和第二部分204各自可以彼此相邻或并排地纵向延伸。
每个部分可以限定内腔。由第一部分202限定的第一内腔212可以从近侧区域210延伸到第一远端区域206。由第二部分204限定的第二内腔214可以从近侧区域210延伸到第二远端区域208。
第一远端区域206中的第一内腔212可以被描述为沿第一轴线216延伸。第二远端区域208中的第二内腔214可以被描述为沿第二轴线218延伸。第一轴线216和第二轴线218形成或限定角度220，使得当第一轴线指向CS中时，第二轴线指向患者的心脏的LV心尖。例如，当细长元件102至少部分地沿第一轴线216推进穿过第一内腔212并且插入到并且任选地锚定在CS中时，第二轴线可以指向LV心尖。当细长元件102推进穿过第一内腔212进入CS中并且第二轴线218指向LV心尖时，推进穿过第二内腔214的装置可以被引导到科赫三角区域中的植入部位。
可以使用任何合适的角度220。角度220可以取决于特定患者的生理机能。在一些实施例中，角度220可以为至少约30、40、50、60或甚至70度。在一些实施例中，角度220可以为至多约110、100、90、80或甚至70度。例如，角度200可以在约50度到约90度的范围内。如本文所使用的，“至多”可以与“小于或等于”互换使用，并且“至少”可以与“大于或等于”互换使用。
在一个或多个实施例中，可以在垂直于患者的心脏的CS口的第一向量与从CS口到LV心尖的第二向量之间限定不同的角度，所述角度可以为至少约30、40、50、60或甚至70度，或者至多约110、100、90、80或甚至70度。
在所展示的实施例中，第二部分204的近侧区域210与第一轴线216对准，并且第二远端区域208与第二轴线218对准。第二部分204的弯曲区域222可以被限定在第二远端区域208与近侧区域210之间。弯曲区域222提供了近侧区域210与远端区域之间的过渡，所述过渡可以比在一些实施例中所展示的更平缓。第一部分202可以沿第一轴线216从近侧区域210相对线性地延伸到第一远端区域206。
在一些实施例中，第二远端区域208也可以是弯曲的。第二远端区域208的对准可以由远端区域的最远侧段限定，或者具体地由延伸穿过远端区域中的第二内腔214的医疗装置的朝向限定。
角度220可以被描述为固定的或可偏转的(例如，弹性的)。当角度220可偏转时，可以使用任何合适的机构来控制、限定或改变所述角度。例如，在一些实施例中，可以使用拉线来限定可偏转角度220。通常，递送导管200可以由任何合适的柔性或半柔性材料形成，以用于向患者的心脏递送装置。在一些实施例中，当用于形成递送导管200的一些或全部的材料足够坚硬以防止在递送期间偏离目标植入区域4时，角度220可以被限定为固定角度。形成第二部分204的第二远端区域208或弯曲区域222的材料可以与形成第二部分的其余部分，如近侧区域210或与第一部分202的材料相同或不同。在一些实施例中，形成第二远端区域208或弯曲区域222的材料可以比形成近侧区域210或第一部分202的材料更坚硬(例如，具有更高的肖氏硬度)。例如，第二远端区域208或弯曲区域222可以由约55D的材料形成，并且近侧区域210或第一部分202可以由约35D或40D的材料形成。
在一些实施例中，第二部分204可以包含编织结构以限定第二内腔214，从而促进形状保持。在一些实施例中，第二部分204可以使用比第一部分202更大的壁厚以促进形状保持。
可以使用任何合适的技术来形成递送导管200。在一些实施例中，递送导管200可以由单个挤压件制成。在其它实施例中，递送导管200可以使用三维(3D)机器打印来制成。可以使用任何合适的材料，如弹性体来形成递送导管200。可以用于形成递送导管200的材料的非限制性实例包含聚醚嵌段酰胺(如PEBAX)、聚氨酯或尼龙中的一种或多种。
可以在将递送导管200引导到患者的心脏时使第二部分204的成角度区域或弯曲区域变直。在一些实施例中，在导丝上跟踪的扩张器可以插入到第二内腔214中并且插入到弯曲区域222和第二远端区域208中，以使第二部分204变直。一旦第二远端区域208到达患者的心脏，扩张器和导丝可以被缩回和取出，以允许第二部分204成形并且与第一部分202形成角度220。
在一些实施例中，第一远端区域206可以延伸到CS中(例如，与仅将细长元件102引导到CS中相反)。在所展示的实施例中，第一部分202比第二部分204更向远侧延伸，使得第一远端区域206沿第一轴线216比第二远端区域208更远，这可以促进插入和锚定在CS中。第一部分202可以延伸超出第二部分204任何合适的量，以促进插入和锚定在CS中。例如，第一部分202可以延伸超出第二部分204至少一英寸或可以延伸超出至多两英寸。
在其它实施例中，第一远端区域206可以朝CS延伸但可以不延伸到CS中。在一个实施例中，第一远端区域206可以不比第二远端区域208或弯曲区域222更向远侧延伸。
递送导管200可以是无源装置或有源装置。在所展示的实施例中，递送导管200可以被描述为包含一个或多个电极224的有源装置。电极224可以耦接到第二部分204的第二远端区域208，并且用于在将装置植入目标植入区域4中之前标测心房激活。一个或多个电极224可以使用延伸穿过近侧区域210的导体(未示出)电耦接到递送导管200的近端。在所展示的实施例中，四个电极224沿第二部分204的远侧面围绕第二内腔214的端部处的开口226布置。电极224可以抵靠RA的科赫三角区域放置，以在装置从第二内腔214通过开口226植入之前标测心房激活。
第一内腔212和第二内腔214可以具有相同或不同的大小以容纳各种类型的装置。如图5C所示，第一内腔212可以限定第一宽度232，并且第二内腔214可以限定第二宽度234。在一些实施例中，第一宽度232和第二宽度234中的一个或两个可以分别被描述为第一直径和第二直径。如图5C所展示的，在一些实施例中，第二宽度234可以大于第一宽度232。例如，第一宽度232可以被大小设定成容纳导丝(例如，容纳0.038英寸导丝的内径)，并且第二宽度234可以被大小设定成容纳起搏引线(例如，容纳7弗伦奇引线的内径)。在其它实施例中，例如当被配置成将导管和类似大小的引线插入到相应的内腔中时，第一宽度232和第二宽度234可以相同或相似(例如，参见图6)。
图6示出了包含互锁组合件的递送导管100(图1)的实施方案的另一个实例的横截面视图。递送导管300在许多方面可以类似于递送导管200(图5A-C)，除了递送导管300可以包含互锁组合件之外，所述互锁组合件包含限定在第一部分302中的外部通道342和从第二部分304侧向延伸的被配置成收纳在所述通道中的凸出部344。通道342可以沿第一部分302的长度可滑动地引导第二部分304。互锁组合件可以允许第一部分302和第二部分304相对于彼此可平移。在一些实施例中，第一部分302可以独立于第二部分304插入。在其它实施例中，通道342可以限定在第二部分304中，并且凸出部344可以从第一部分302侧向延伸。
如本文关于递送导管所使用的，术语“侧向”是指远离纵向轴线的方向，如由第一部分302限定的第一轴线或由第二部分304限定的第二轴线。在一些实施例中，侧向可以是与纵向轴线正交的方向。
通道342和互补凸出部344可以分别具有任何合适的深度和互补高度，以促进引导。在一些实施例中，深度或高度可以为至少约0.5、1、1.5或甚至2mm。在一些实施例中，深度或高度可以为至多约3、2.5、2、1.5或甚至1mm。例如，深度或高度可以在约1mm到约2mm的范围内。
通道342可以沿第一部分302延伸任何合适的长度。在一些实施例中，通道342沿第一部分302的整个长度延伸。在一些实施例中，通道342可以包含远端，所述远端在未达到第一部分302的远端时停止。
凸出部344可以沿第二部分304延伸任何合适的长度。在一些实施例中，凸出部344安置在第二部分304的细长主体上的一个或多个离散位置处。例如，每个凸出部344可以具有沿第二部分304的长度至多约1、2、3或甚至4厘米(cm)的长度。在一个实施例中，凸出部344仅安置在一个离散位置处。在一些实施例中，凸出部344沿第二部分304的更大长度延伸。例如，凸出部344的长度可以为至少约1、2、3或甚至4cm，直至第二部分304的整个长度。凸出部344可以连续或离散地延伸。
凸出部344可以沿第二部分304定位在任何合适的位置。在一些实施例中，离散凸出部344可以定位在远端区域、弯曲区域、近侧区域、非弯曲区域或这些区域中的任何区域之间。
图7是示出了使用本公开的递送导管的方法400的一个实例的流程图。方法400可以包含使递送导管或双内腔导管的第一远端区域朝CS推进402。在一些实施例中，第一远端区域可以插入到CS中。方法400还可以包含使递送导管的第二远端区域朝科赫三角区域定向404。使递送导管定向可以涉及扭转以使第二部分围绕第一部分旋转，直到例如当第一远端区域完全朝CS推进时第二部分的端部指向LV心尖。如本文相对于递送导管所使用的，术语“扭转”是指向递送导管施加旋转力或扭矩。方法400还可以包含穿过递送导管将医疗装置植入到科赫三角区域中406。在一些实施例中，植入式医疗装置可以推进穿过递送导管的延伸穿过第二远端区域的第二内腔。植入式医疗装置可以固定到科赫三角中的植入部位或目标植入区域。
通常，可以使用延伸穿过递送导管的第一远端区域的第一内腔使递送导管在如导丝或另一个导管等细长元件上朝CS推进。
图8是示出了使用用于细长元件的导丝和具有第一内腔和第二内腔的整体形成的递送导管的方法410的一个实例的流程图。方法410可以包含使插管导管推进到CS中412。具体地，插管导管可以在导丝上插入到锁骨下静脉中并且穿过上腔静脉(SVC)以进入RA，并且然后用于对CS进行插管。导丝可以通过插管导管被推进到CS中。
在一些实施例中，导丝可以被锚定在CS中。例如，导丝可以被推进超过约1、2、3、4、5或甚至6cm进入CS并且甚至进入心大静脉(GCV)，以将导丝锚定在CS中。方法410可以包含取出插管导管并且将导丝留在原位414。
方法410还可以包含使用递送导管的第一内腔使递送导管或双内腔导管在导丝上朝CS推进416。可以沿导丝跟踪递送导管，直到递送导管防止进一步推进。例如，形成第二内腔的一部分可能被CS口阻止进一步推进。
方法410可以包含使递送导管的第二内腔朝患者的心脏的科赫三角区域定向418。在一些实施例中，递送导管被扭转使得递送导管的限定第二内腔的第二部分(其可以具有固定的或可偏转的曲线)与科赫三角区域中的目标植入位置中的组织接触。
方法410还可以包含穿过第二内腔将装置植入到科赫三角区域中420。第二内腔可以将装置从植入位置朝LV心尖引导，这可以促进植入装置用于VfA心脏疗法。一旦就位，所述装置就可以固定在植入位置处。方法410可以包含取出递送导管422。例如，递送导管可以被切开并且缩回。
图9是示出了使用用于细长元件的疗法导管(例如，EP导管)和限定第一内腔和第二内腔的整体形成的递送导管的方法430的另一个实例的流程图。方法430可以包含使疗法导管推进到CS中432。具体地，疗法导管可以在导丝上插入到锁骨下静脉并且穿过SVC以进入RA，并且然后用于对CS进行插管。疗法导管可以锚定在CS中。例如，疗法导管可以被推进超过数厘米进入CS并且甚至进入心大静脉(GCV)，以将疗法导管锚定在CS中。导丝也可以以类似的方式通过疗法导管被推进到CS中。
方法430还可以包含使用递送导管的第一内腔使递送导管或双内腔导管在疗法导管上朝CS推进434。可以沿疗法导管跟踪递送导管，直到递送导管防止进一步推进。例如，形成第二内腔的一部分可能被CS口阻止进一步推进。
方法430可以包含使递送导管的第二内腔朝患者的心脏的科赫三角区域定向436。在一些实施例中，递送导管被扭转使得递送导管的限定第二内腔的第二部分(其可以具有固定的或可偏转的曲线)与科赫三角区域中的目标植入位置中的组织接触。
方法430还可以包含穿过第二内腔将装置植入到科赫三角区域中438。第二内腔可以将装置从植入位置朝LV心尖引导，这可以促进植入装置用于VfA心脏疗法。一旦就位，所述装置就可以固定在植入位置处。方法430可以包含取出递送导管440。例如，递送导管可以被切开并且缩回。疗法导管可以被保留或取出。例如，当取出递送导管时，也可以取出导丝。
图10是示出了使用用于细长元件的导丝和具有可平移的第一部分和第二部分的可分开地形成的递送导管的方法450的另一个实例的流程图。方法450可以包含使递送导管的第一部分在导丝上推进452。具体地，限定第一内腔的第一部分可以在导丝上插入到锁骨下静脉并且穿过SVC以进入RA，并且然后用于对CS进行插管。导丝可以通过第一内腔被推进到CS中。
方法450可以包含使用互锁组合件，如通道和互补凸出部可平移地耦接第一部分和第二部分454。具体地，第二部分的凸出部可以插入到第一部分的通道中。
方法450可以包含使限定第二内腔的第二部分在第一部分上朝CS推进456。可以沿第一部分的通道跟踪第二部分的凸出部，直到第二部分防止进一步推进。例如，形成第二内腔的第二部分可能被CS口阻止进一步推进。
方法450可以包含使第二部分的第二内腔朝患者的心脏的科赫三角区域定向458。在一些实施例中，递送导管被扭转使得递送导管的第二部分(其可以具有固定的或可偏转的曲线)与科赫三角区域中的目标植入位置中的组织接触。
方法450还可以包含穿过第二内腔将装置植入到科赫三角区域中460。第二内腔可以将装置从植入位置朝LV心尖引导，这可以促进植入装置用于VfA心脏疗法。一旦就位，所述装置就可以固定在植入位置处。方法450可以包含取出递送导管462。例如，递送导管可以被切开并且缩回。
说明性实施例
尽管本公开不如此限制，但是将通过对以下提供的具体说明性实施例的讨论来获得对本公开的各个方面的理解。对说明性实施例的各种修改以及本公开的另外的实施例在本文中将变得显而易见。
在说明性实施例A1中，一种植入式医疗装置递送系统包含细长元件，所述细长元件可锚定在患者的心脏的冠状窦(CS)中。所述系统还包含递送导管，所述递送导管具有细长主体，所述细长主体具有限定第一内腔的第一部分和限定第二内腔的第二部分。位于所述第一部分的第一远端区域中的所述第一内腔沿第一轴线延伸，并且位于所述第二部分的第二远端区域中的所述第二内腔沿与所述第一轴线形成一定角度的第二轴线延伸。当可锚定的细长元件推进穿过所述第一内腔进入CS中时，所述第二轴线指向患者的心脏的左心室(LV)心尖。
在说明性实施例A2中，根据任一A说明性实施例所述的系统，其进一步包含递送导管，所述递送导管被配置成使得当所述细长元件推进穿过所述第一内腔进入CS中并且所述第二轴线指向LV心尖时，推进穿过所述第二内腔的植入式医疗装置被引导到所述患者的心脏的科赫三角区域中的植入部位。
在说明性实施例A3中，根据说明性实施例A2所述的系统，其进一步包含所述植入式医疗装置。所述植入式医疗装置包含用于向所述患者的心脏的右心房(RA)或LV提供心脏疗法或感测所述患者的心脏的RA或LV的电活动的至少一个电极。
在说明性实施例A4中，根据任一A说明性实施例所述的系统，其进一步包含作为带引线的植入式医疗装置的植入式医疗装置。
在说明性实施例A5中，根据任一A说明性实施例所述的系统，其进一步包含作为固定角度的角度。
在说明性实施例A6中，根据任一A说明性实施例所述的系统，其进一步包含作为导丝或导管的细长元件。
在说明性实施例A7中，根据任一A说明性实施例所述的系统，其进一步包含具有可锚定的球囊和可锚定的侧螺旋中的一个或两个的细长元件。
在说明性实施例A8中，根据任一A说明性实施例所述的系统，其进一步包含具有一个或多个电极的细长元件。
在说明性实施例A9中，根据任一A说明性实施例所述的系统，其进一步包含一个或多个电极，所述一个或多个电极耦接到所述第二部分的所述第二远端区域以标测心房激活。
在说明性实施例A10中，根据任一A说明性实施例所述的系统，其进一步包含比所述细长主体的近侧区域和所述细长元件中的一个或两个更具柔性的第二远端区域。
在说明性实施例A11中，根据任一A说明性实施例所述的系统，其进一步包含相对于所述第一轴线位于所述第一远端区域的远侧的第二远端区域。
在说明性实施例A12中，根据任一A说明性实施例所述的系统，其进一步包含至多90度的角度。
在说明性实施例B1中，一种递送导管包含可推进到患者的心脏的冠状窦(CS)中的第一部分，所述第一部分具有限定第一内腔和外部通道的细长主体。当所述第一部分被推进到CS中时，所述第一部分的与患者的心脏的CS口相邻的区域沿第一轴线延伸。所述装置包含第二部分，所述第二部分具有限定第二内腔的细长主体并且具有侧向延伸的凸出部，所述侧向延伸的凸出部被配置成收纳在所述第一部分的外部通道中，以便沿所述第一部分的长度可滑动地引导所述第二部分。当所述凸出部接合在通道中时，第二部分的远端区域沿与第一轴线形成固定角度的第二轴线延伸，使得当第一部分被推进到CS中时，所述第二轴线指向患者的心脏的左心室(LV)心尖。
在说明性实施例B2中，根据任一B说明性实施例所述的系统，其进一步包含植入式医疗装置，当所述第一部分被推进到CS中并且所述第二轴线指向LV心尖时，推进穿过所述第二内腔的植入式医疗装置被引导到所述患者的心脏的科赫三角区域中的植入部位。
在说明性实施例B3中，根据说明性实施例B2所述的系统，其进一步包含所述植入式医疗装置。所述植入式医疗装置包含用于向所述患者的心脏的右心房(RA)或LV提供心脏疗法或感测所述患者的心脏的RA或LV的电活动的至少一个电极。
在说明性实施例B4中，根据任一B说明性实施例所述的系统，其进一步包含被安置在所述第二部分的所述细长主体上的离散位置处的凸出部。
在说明性实施例B5中，根据任一B说明性实施例所述的系统，其进一步包含一个或多个电极，所述一个或多个电极耦接到所述第二部分的所述远端区域以标测心房激活。
在说明性实施例C1中，一种递送植入式医疗装置的方法包含使双内腔导管的第一部分的第一远端区域朝患者的心脏的冠状窦(CS)推进。所述第一部分限定第一内腔，并且所述第一远端区域沿第一轴线延伸。所述方法包含使双内腔导管的第二部分的第二远端区域朝患者的心脏的科赫三角区域定向。所述第二部分限定第二内腔，并且所述第二远端区域沿与所述第一轴线形成一定角度的第二轴线延伸，使得使得当所述第一远端区域完全朝CS推进时，所述第二轴线指向所述患者的心脏的左心室(LV)心尖。
在说明性实施例C2中，根据任一C说明性实施例所述的方法，其进一步包含旋转所述双内腔导管以使所述第二轴线指向LV心尖；使植入式医疗装置推进穿过所述双内腔导管的所述第二内腔；以及将所述植入式医疗装置固定到所述患者的心脏的所述科赫三角区域中的植入部位。
在说明性实施例C3中，根据任一C说明性实施例所述的方法，其进一步包含使细长元件推进到所述患者的心脏的所述冠状窦(CS)中。当所述细长元件被推进到CS中时，所述细长元件的与CS口相邻的一部分沿所述第一轴线延伸。所述方法包含使用所述第一内腔在所述细长元件上使所述双内腔导管推进以将所述第一远端区域朝CS引导。
在说明性实施例C4中，根据说明性实施例C3所述的方法，其进一步包含具有导丝的细长元件，并且所述方法进一步包含使插管导管推进到所述患者的心脏的CS中；使所述导丝推进通过所述插管导管进入CS中；以及取出所述插管导管。
在说明性实施例C5中，根据任一C说明性实施例所述的方法，其进一步包含第一部分，所述第一部分限定外部通道；以及第二部分，所述第二部分具有被配置成收纳在所述外部通道中的侧向延伸的凸出部。所述方法包含使用与所述外部通道接合的所述凸出部推进由所述第一部分引导的所述第二部分；使所述第二部分定向成使所述第二轴线指向LV心尖；使植入式医疗装置推进穿过所述双内腔导管的所述第二内腔；以及将所述植入式医疗装置固定到所述患者的心脏的所述科赫三角区域中的植入部位。
因此，公开了用于VFA心脏疗法的递送系统的各个实施例。本公开的技术提供了一种递送导管，所述递送导管使用CS作为物理参考，使植入式医疗装置稳定在适当的位置和朝向，以便在目标植入区域处进行植入，特别是在科赫三角区域中，以向LV递送起搏。
应当理解，本文公开的各个方面可以与说明书和附图中具体呈现的组合不同的组合进行组合。还应当理解，根据实例，本文所述的任何过程或方法的某些动作或事件可以以不同顺序执行，可以被添加、合并或一起省略(例如，所有所描述的动作或事件对于执行所述技术可能不是必需的)。另外，尽管为了清楚起见，将本公开的某些方面描述为由单个模块或单元来执行，但是应当理解，本公开的技术可以由与例如医疗装置相关联的单元或模块的组合来执行。
在一个或多个实例中，所描述技术可以以硬件、软件、固件或其任何组合实施。如果以软件实施，则功能可以作为一个或多个指令或代码存储在计算机可读介质上并由基于硬件的处理单元执行。计算机可读介质可以包含非暂时性计算机可读介质，其与有形介质相对应，如数据存储介质(例如，RAM、ROM、EEPROM、闪速存储器或可以用于存储呈指令或数据结构形式的期望程序代码并且可以由计算机访问的任何其它介质)。
指令可以由一个或多个处理器执行，如一个或多个数字信号处理器(DSP)、通用微处理器、专用集成电路(ASIC)、现场可编程逻辑阵列(FPGA)或其它等效的集成或离散逻辑电路系统。因此，如本文所使用的术语“处理器”可以指任何前述结构或适合于实施所描述技术的任何其它物理结构。而且，所述技术可以完全实施在一个或多个电路或逻辑元件中。
出于所有目的，本文所引用的所有参考文献和出版物均通过引用整体引用于此，除非任何方面与本公开直接矛盾。
除非另外说明，否则本文所使用的所有科学和技术术语均具有本领域中常用的含义。本文提供的定义是为了促进对本文中经常使用的某些术语的理解，并不意味着限制本公开的范围。
除非另有说明，否则在说明书和权利要求书中使用的所有表示特征大小、数量和物理性质的数字都可以理解为被术语“完全”或“约”修饰。因此，除非有相反的指示，否则前述说明书和所附权利要求书中所示的数值参数是近似值，其可以根据本领域的技术人员利用本文公开的教导或例如在实验误差的典型范围内寻求获得的所需性质而变化。
通过端点列举的数值范围包含纳入所述范围内的所有数字(例如，1到5包含1、1.5、2、2.75、3、3.80、4和5)以及所述范围内的任何范围。在本文中，术语“至多”或“不大于”一个数字(例如，至多50)包含所述数字(例如，50)，并且术语“至少”或“不小于”一个数字(例如，不小于5)包含所述数字(例如，5)。
与朝向有关的术语，如“近侧”、“远侧”、“侧”和“端部”用于描述组件的相对定位，并且不意味着限制所考虑的实施例的朝向。
术语“耦接”或“连接”是指元件彼此直接附接(彼此直接接触)或间接附接(在两个元件之间具有一个或多个元件并且附接所述两个元件)。这两个术语均可以由“操作性地(operatively)”和“可操作地(operably)”修饰，其可以互换使用，以描述耦接或连接被配置成允许组件交互以执行功能。
如本文所使用的，术语“被配置成”可以与术语“适于”或“被结构化成”互换使用，除非本公开的内容另外清楚地指明。
单数形式“一个(a)”、“一种(an)”和“所述(the)”涵盖具有复数指示物的实施例，除非其上下文另外清楚地指明。
术语“或”通常以其包含性意义使用，例如意指“和/或”，除非上下文另外清楚地指明。
术语“和/或”意指所列元件中的一个或全部或所列元件中的至少两个的组合。
列表跟随的短语“至少一个”、“包括至少一个”和“一个或多个”指的是列表中的任何一项以及列表中两个或更多个项的任意组合。
如本文所使用的，“具有(have)”、“具有(having)”、“包含(include)”、“包含(including)”、“包括(comprise)”、“包括(comprising)”等以其开放式意义使用，并且通常意指“包含但不限于”。将理解的是，“基本上由……组成(consisting essentially of)”、“由……组成(consisting of)”等被归入在“包括”等中。
提及“一个实施例(one embodiment)”、“实施例(an embodiment)”、“某些实施例(certain embodiments)”或“一些实施例(some embodiments)”等意指结合实施例描述的特定特征、配置、组成或特性包含在本公开的至少一个实施例中。因此，这些短语在全文中各个地方的出现不一定是指本公开的同一实施例。此外，在一个或多个实施例中，可以以任何合适的方式组合特定的特征、配置、组成或特性。

Claims (12)

1.一种植入式医疗装置递送系统，其包括：
细长元件，所述细长元件能够锚定在患者的心脏的冠状窦(CS)中；以及
递送导管，所述递送导管包括细长主体，所述细长主体具有限定第一内腔的第一部分和限定第二内腔的第二部分，其中位于所述第一部分的第一远端区域中的所述第一内腔沿第一轴线延伸，并且位于所述第二部分的第二远端区域中的所述第二内腔沿与所述第一轴线形成一定角度的第二轴线延伸，其中当所述可锚定的细长元件推进穿过所述第一内腔进入CS中时，所述第二轴线指向所述患者的心脏的左心室(LV)心尖。
2.根据权利要求1所述的系统，其中所述递送导管被配置成使得当所述细长元件推进穿过所述第一内腔进入CS中并且所述第二轴线指向LV心尖时，推进穿过所述第二内腔的植入式医疗装置被引导到所述患者的心脏的科赫三角(triangle of Koch)区域中的植入部位。
3.根据权利要求2所述的系统，其进一步包括所述植入式医疗装置，所述植入式医疗装置包括用于向所述患者的心脏的右心房(RA)或LV提供心脏疗法或感测所述患者的心脏的RA或LV的电活动的至少一个电极。
4.根据权利要求3所述的系统，其中所述植入式医疗装置包括带引线的植入式医疗装置。
5.根据前述权利要求中任一项所述的系统，其中所述角度是固定角度。
6.根据前述权利要求中任一项所述的系统，其中所述细长元件包括导丝或导管。
7.根据前述权利要求中任一项所述的系统，其中所述细长元件包括可锚定的球囊和可锚定的侧螺旋中的一个或两个。
8.根据前述权利要求中任一项所述的系统，其中所述细长元件包括一个或多个电极。
9.根据前述权利要求中任一项所述的系统，其中一个或多个电极耦接到所述第二部分的所述第二远端区域，以标测心房激活。
10.根据前述权利要求中任一项所述的系统，其中所述第二远端区域比所述细长主体的近端区域和所述细长元件中的一个或两个更具柔性。
11.根据前述权利要求中任一项所述的系统，其中所述第二远端区域相对于所述第一轴线位于所述第一远端区域的远侧。
12.根据前述权利要求中任一项所述的系统，其中所述角度为至多90度。
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US20200306529A1 (en) 2020-10-01

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