CN109310865A - 电刺激治疗充血性心力衰竭，以及相关联的系统和方法 - Google Patents

电刺激治疗充血性心力衰竭，以及相关联的系统和方法 Download PDF

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CN109310865A
CN109310865A CN201780019179.7A CN201780019179A CN109310865A CN 109310865 A CN109310865 A CN 109310865A CN 201780019179 A CN201780019179 A CN 201780019179A CN 109310865 A CN109310865 A CN 109310865A
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ejection fraction
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杰姆斯·R·泰克
凯里·布兰得利
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Abstract

本文公开了用高频刺激治疗充血性心力衰竭的系统和方法。用于治疗患者的代表性方法包括通过治疗系统向患者施加频率为约1kHz至约100kHz的电信号，该治疗系统包括与位于患者心脏的前室间交界处或其附近的迷走神经的一部分处的患者的迷走神经电连通的信号传递元件。该方法还可以包括自动检测患者的至少一个生理参数，基于检测到的参数自动确定患者心脏的射血分数和射血分数的相关系数(correlate)中的至少一个，并根据所确定的射血分数自动调节所施加的信号。

Description

电刺激治疗充血性心力衰竭，以及相关联的系统和方法
相关申请交叉引用
本申请要求2016年1月25日提交的待决美国临时申请No.62/286,892的优先权，并且通过引用将其并入本文。
技术领域
本技术一般涉及用电刺激治疗充血性心力衰竭，以及相关联的系统和方法。
背景技术
充血性心力衰竭(CHF)是一种慢性病症，其特征在于心脏的一个或两个主泵室(左心室和右心室)的收缩强度(例如，收缩性)降低。心室的收缩性降低减少了每次心跳每个心室喷射的血液量(例如，每搏输出量)。当这种情况发生时，心脏不能正常地泵血，并且血液和其他流体开始在心血管系统和身体的其他部位(例如肺、肝、腹部和下肢)中积聚。在CHF的一些情况下，心肌(例如，心肌组织)变得如此弱，以至于心室伸展或扩张，从而损坏位于心室壁中的浦肯野纤维(Purkinje fibers)。浦肯野纤维负责将收缩冲动传递到心室的心肌，因此扩张的心室对浦肯野纤维的损坏损害了心脏的电传导系统并降低了收缩的同步性，进一步损害了射血分数(ejection fraction)。因此，需要用于治疗充血性心力衰竭的系统和方法。
附图说明
图1A和1B分别是人类心脏的前视图和后视图。
图2A是根据本技术的若干实施例的可植入治疗系统的部分示意图，该可植入治疗系统被定位成向心脏传递电信号。
图2B是根据本技术的若干实施例的可植入治疗系统的一部分的局部示意图，该可植入治疗系统被定位成向心脏传递电信号。
图3是根据本技术的实施例示出的用于治疗充血性心力衰竭的方法的流程图。
图4是根据本技术的实施例示出的用于确定代表性(例如，最大)治疗幅度(amplitude)的方法的流程图。
图5是根据本技术的实施例示出的用于响应于实时射血分数反馈来调整治疗信号的方法的流程图。
具体实施例
本技术一般涉及用于治疗充血性心力衰竭(CHF)的系统，并且特别涉及通过电刺激改善左心室和/或右心室的收缩强度来治疗CHF的系统。在一个实施例中，本技术包括治疗系统，该治疗系统具有可植入信号发生器和信号传递元件，该信号传递元件被配置为将电信号施加到支配患者心脏的一部分的副交感神经。该系统包括一个或多个实时反馈机制，用于评估所施加信号的功效并基于该功效自动调整所施加的信号。例如，在一些实施例中，治疗系统可以自动确定患者的心脏的射血分数并且基于射血分数调整所施加的电信号的一个或多个参数。
在标题1.0(“定义”)下提供所选术语的定义。所公开的技术操作的解剖学和生理学环境的一般方面在下面标题2.0(“引言”)下参考图1A和1B描述。下面参考图2A和2B在标题3.0(“概述”)下描述所公开技术操作的处理系统的概述。参考图3-5，在标题4.0(“代表性实施例”)下进一步描述了该技术的特定实施例。在标题5.0(“附加实施例”)下描述了另外的实施例。
1.0定义
如本文所用，“迷走神经(vagus nerve)”是指以下任何一种：左迷走神经，右迷走神经和/或颈迷走神经的部分，迷走神经的分支，例如上心神经、上心分支、下心分支和迷走神经干。类似地，本文通过说明而非限制的方式描述了对迷走神经的刺激，并且应理解，在本技术的一些实施方案中，其他自主神经和/或副交感神经和/或副交感神经组织被刺激，包括迷走神经支配目标器官、迷走神经节、心外膜脂肪垫中的神经、颈动脉、颈静脉(例如颈内静脉)、颈动脉窦、冠状窦、腔静脉、肺静脉和/或右心室的位置，以用于治疗心脏病或其他病症。
如本文所用，“高频”或“HF”是指约1kHz至约100kHz，或约1.2kHz至约100kHz，或约1.5kHz至约100kHz，或约2kHz至约50kHz，或约3kHz至约20kHz，或约3kHz至约15kHz，或约5kHz至约15kHz，或约3kHz至约10kHz，或1kHz、2kHz、3kHz、4kHz、5kHz、8kHz、9kHz、10kHz、11kHz、12kHz、15kHz、20kHz、50kHz或100kHz的频率。如本文所用，术语“约”是指在所述值的+/-10％内的值。此外，如本文所用，“低频”或“LF”是指小于约1kHz的频率。
如本文所用，“实时”是指在10秒或更短的时间内，在5秒或更短的时间内，在3秒或更短的时间内，在2秒或更短的时间内，在1秒或更短的时间内，在0.5秒或更短的时间内，在0.25秒或更短的时间内，以及在0.1秒或更短的时间内。
2.0简介
图1A和1B分别是人心脏H的前视图和后视图。如图1A和1B所示，心脏H包括四个腔室，右心房RA、左心房LA、右心室RV和左心室LV。右心房和左心房RA，LA通过称为冠状动脉或房室沟AVS的沟槽与右心室和左心室RV，LV分开。前室间沟AIS和后室间沟PIS是分隔右心室和左心室RV，LV的凹槽。每个房室沟AVS、前室间沟AIS和后室间沟PIS都被心外膜脂肪垫FP包围。心脏大静脉GCV在心脏的顶点A附近开始并且在前室间沟AIS内向上延伸，直到最终在房室沟AVS内的心脏H的左侧弯曲。心脏大静脉GCV的后部排空到冠状窦CS中，冠状窦CS也位于房室沟AVS内。
3.0概述
图2A示意性地示出了用于改善患者心脏H的收缩性的代表性治疗系统100，其相对于患者心脏H和胸部区域的一般解剖结构布置。如图2A所示，心肌的副交感神经支配部分地由迷走神经V控制，迷走神经V具有进入位于心外膜脂肪垫FP上、内和/或附近的一个或多个神经丛N的分支。治疗系统100包括信号传递系统101，其具有信号发生器102(例如，脉冲发生器)和信号传递装置或元件104。信号发生器102可以直接连接到信号传递元件104，或者它可以是经由信号链路108(例如，延伸部)耦接到信号传递元件104。在一个实施例中，信号发生器102可以通过无线信号通信或无线信号传输连接到信号传递元件104。在一些实施例中，信号发生器102可以被皮下植入患者P内，而在其他实施例中，信号发生器102可以在患者体外。如图2A所示，信号传递元件104被配置成定位在心外膜脂肪垫FP处或附近，并且将电信号施加到相邻的迷走神经丛N。据信在心外膜脂肪垫FP处或附近的高频调制可以调制位于心外膜脂肪垫FP上或内的副交感神经丛N，从而改善副交感神经张力(tone)(例如，副交感神经纤维的电活动)和心室收缩强度。因此，在一个实施例中，施加到迷走神经丛N的电信号是高频电信号(或高频治疗信号)。
信号发生器102可以将信号(例如，电信号或治疗信号)传送到信号传递元件104，其上调(例如，刺激或激发)和/或下调(例如，阻断或抑制)目标神经(例如，局部迷走神经)。如本文所用，并且除非另有说明，否则“调制”、“刺激”或向目标神经提供“调制”或“刺激”通常是指对目标神经具有任何类型的前述作用。信号发生器102可以包括机器可读(例如，计算机可读)介质，其包含用于生成和传送合适的治疗信号的指令。信号发生器102和/或治疗系统100的其他元件可包括一个或多个处理器110、存储器112和/或输入/输出装置。因此，提供电信号、检测患者的生理参数、确定射血分数、调整调制信号和/或执行其他相关联的功能的过程可以由位于信号发生器102和/或其他系统组件处的计算机可读介质所包含的计算机可执行指令来执行。信号发生器102可以包括容纳在如图2A所示的单个壳体中或者在多个壳体中的多个部分、元件和/或子系统(例如，用于根据多个信号传递参数引导信号)。
信号传递系统101可包括一个或多个传感元件140，用于在施加电疗信号之前、期间和/或之后检测患者的一个或多个生理参数。在一些实施例中，一个或多个传感元件140可以由信号发生器102、信号传递元件104和/或系统101的其他植入组件承载。在其他实施例中，传感元件140可以是一种与信号发生器102和/或信号传递元件104分开的体外或可植入装置。代表性的传感元件140包括以下中的一个或多个：心电图(“ECG”)单元、阻抗心电图单元、皮下传感器、心室传感器、活动传感器(例如，加速度计)、心室心内传感器、心房心内传感器、温度传感器、流速传感器、化学传感器、生物传感器、电化学传感器、血液动力传感器、光学传感器和/或其他合适的传感装置。由传感元件140检测的生理参数包括心率、血压、血流速率、活动水平、ECG读数、阻抗心动描记读数、心室和/或心房压力，和/或前述参数的任何相关系数(correlate)和/或导数(derivative)(例如，原始数据值，包括电压和/或其他直接测量值)。
在代表性的实施例中，信号传递系统101被配置为以“校准模式”或“活动模式”操作。在校准模式中，信号传递系统101被配置为经由治疗部位处的信号传递元件104施加低频电信号(在本文中也称为“LF校准信号”)以确定代表性的(例如，最大值)信号幅度，该信号幅度可以在后续治疗期间被应用。在一个实施例中，例如，最大信号幅度在校准模式期间被确定为以下值中的较低者：(1)观察到心率、心肌激活或室测序的直接、立即变化的幅度，和(2)产生由患者感知的感觉的幅度。在特定实施例中，信号传递系统101还被配置为当处于校准模式时应用高频电信号(这里称为“HF校准信号”)以验证由LF校准信号识别的最大信号幅度。在活动模式中，信号传递系统101被配置为在治疗部位施加高频电信号(在本文中也称为“HF治疗(treatment)信号”或“HF治疗(therapy)信号”)以调制治疗部位附近的副交感神经。在校准模式和/或活动模式期间由信号传递系统101施加的电信号的参数可以(1)响应于反馈机制和/或根据预设程序自动调节(参考图3-5更详细地描述)，(2)根据患者和/或从业者输入进行手动调节，和/或(3)以随机或伪随机方式自动调节。例如，医生可能会发现降低靶神经发生适应性神经重塑(neuroplastic)的反应的可能性是有益的，这种反应可能会降低所施加信号随时间的有效效果。在这种情况下，可以使用算法来改变所施加的以伪随机方式传递能量的幅度。例如，医生可以设置信号幅度的边界，例如0mA的下边界和校准期间确定的上边界。另外，医生可以指定用于在预设界限内改变幅度的时间表，例如在心室不应期期间每N次搏动一次幅度改变，在心室不应期间每次搏动M次改变，等。信号参数包括，例如，频率、幅度、脉冲宽度和占空比。应当理解，在其他实施例中，信号传递系统101可以被配置为以多于两种模式操作。
在一些实施例中，信号发生器102可从外部电源114获得电力以产生治疗信号。外部电源114可通过使用电磁感应(例如，RF信号)将电力传输到可植入的信号发生器102。例如，外部电源114可以包括外部线圈116，该外部线圈116与可植入的信号发生器102内的相应内部线圈(未示出)通信。外部电源114可以是便携式的以便于使用。
在另一个实施例中，除了外部电源114之外或代替外部电源114，信号发生器102可以从内部电源获得电力以产生治疗信号。例如，可植入的信号发生器102可以包括非可充电电池或可充电电池以提供这种电力。当内部电源包括可充电电池时，外部电源114可用于为电池充电。外部电源114又可以从合适的电源(例如，传统的壁式电源)再充电。
在至少一些过程期间，在植入信号发生器102之前，外部编程器120(例如，试验调制器)可以在初始过程期间被耦接到信号传递元件104。例如，从业者(例如，医生和/或公司代表)可以在校准模式下使用外部编程器120来实时改变提供给信号传递元件104的信号参数，并选择最佳或特别有效的信号参数和/或信号传递元件104布置，如在下面参考图4更详细地讨论的那样。在一个典型的过程中，从业者使用电缆组件128将外部编程器120临时连接到信号传递元件104。无论是校准信号传递系统101还是应用HF治疗信号，从业者可以测试信号传递元件104在初始位置和/或初始信号参数的功效。然后，从业者可以断开电缆组件128(例如，在连接器130处)，重新定位信号传递元件104，并重新施加电信号。该过程可以迭代地执行，直到从业者确认所需的治疗信号参数和/或信号传递元件104的位置在临床上有效。可选地，从业者可以在不断开电缆组件128的情况下移动部分植入的信号传递元件104。
在与外部编程器120的试验期之后，从业者可以将可植入的信号发生器102植入患者P内以进行长期治疗。在信号发生器102植入之后，仍然可以通过无线的医生的编程器124(例如，医生的遥控器)更新由信号发生器102提供的信号传递参数。
图2B是与在心脏大静脉GCV内植入的信号传递元件104一起的心脏H的部分示意图。出于清楚的目的，图2A中描绘的副交感神经纤维N未在图2B中示出。在代表性实施例中，信号传递元件104包括柔性的、等径的引线或引线体，其承载用于在植入后将电信号传递到治疗部位的特征或元件。如本文所用，术语“引线”和“引线体”包括许多合适的基底和/或支撑构件中的任何一种，其携带用于向患者提供治疗信号的装置。例如，引线体可包括将电信号引导到患者组织中的一个或多个电极或电触点105，例如，以改善副交感神经张力(例如，副交感神经电活动)。在其他实施例中，信号传递元件104可包括除引线体(例如，桨叶)和/或其他引线配置(例如，心脏起搏引线、可植入心律转复除颤器(ICD)引线、心脏再同步治疗(CRT)引线、左心脏引线、心外膜引线等)，其也将电信号和/或其他类型的信号引导至患者。在特定实施例中，信号传递系统101(图2A)包括一个以上的信号传递元件104(例如，两个信号传递元件104、三个信号传递元件104、四个信号传递元件104等)，每个都被配置为在不同位置施加电信号和/或协调信号传递以将组合信号传递到相同(或通常相同)的解剖位置。
如图2B所示，信号传递元件104可以沿着位于前室间沟AIS处或附近的心脏大静脉GCV的至少一部分定位。在其他实施例中，信号传递元件104可以定位在心外膜脂肪垫FP处或附近的其他心脏位置处。如本文所用，“在心外膜脂肪垫处或附近”是指信号传递元件104的位置是在与靶心外膜脂肪垫FP直接接触和/或与靶脂肪垫FP的脂肪细胞组织直接接触的冠状血管中、在其上或以其他方式与其直接接触的位置。例如，信号传递元件104可以直接被耦接到脂肪垫FP组织，其定位在冠状动脉内、定位在冠状静脉内并且不与靶心外膜脂肪垫FP直接接触和/或与靶脂肪垫FP的脂肪细胞组织直接接触(例如，中心静脉、小心静脉、一个或多个前心脏静脉、冠状窦等)、位于冠状动脉和/或冠状静脉的外部、沿着远离前室间沟AIS的心脏大静脉GCV的至少一部分定位(例如，位于或接近房室沟AVS，等)和/或其他合适的位置。在一些实施例中，信号传递元件104可以定位在冠状血管上或冠状血管内，使得信号传递元件104跨越宿主血管的多于一个部分。例如，信号传递元件104可以定位成使得(a)信号传递元件104的第一部分与前室间沟AIS处或附近的心脏大静脉GCV的至少一部分重合，以及(b)信号传递元件104的第二部分与在心房沟AVS处或附近的心脏大静脉GCV的至少一部分重合。在特定实施例中，信号传递元件104可以被耦接到和/或将电信号施加到一种以上类型的组织(例如，脂肪垫FP的脂肪组织和副交感神经丛N的神经组织(图2A)、血管的结缔组织和副交感神经丛N的神经组织等。
4.0代表性的实施例
图3-5示出了利用上面参考图2A和2B描述的治疗系统100治疗CHF和/或改善心脏收缩性的代表性方法。图3示出了根据本公开的特定实施例的整个过程300。整个过程300包括确定代表性的(例如，最大的)治疗幅度(过程部分310)、经由信号传递系统101(图2A)向患者施加HF治疗信号(过程部分312)、并自动检测患者的一个或多个生理参数(过程部分314)。过程300还可以包括基于检测到的生理参数自动确定患者心脏的射血分数(过程部分316)，并且，基于所确定的射血分数，自动调节HF治疗信号的一个或多个参数(过程部分318)。图4和5描述了前述过程的特定实施例的其他方面。
图4是示出用于在调节神经之前确定代表性的(例如，最大)信号幅度以防止在治疗期间对心脏的电传导系统的不期望的影响(例如，心动过速、心动过缓等)。在框410中，在信号传递系统101(图2A)处于校准模式的情况下，从业者将校准信号施加到治疗部位。在所示的实施例中，应用LF校准信号。然而，在替代实施例中，可以应用HF校准信号。在特定实施例中，LF校准信号可具有约0.1至约2.5Hz的频率，并且在一些实施例中，小于1Hz。在一些实施例中，LF校准信号可具有大于600微秒的脉冲宽度，在某些实施方案中，为约100微秒至约2.5毫秒。在应用LF校准信号期间，从业者和/或系统处理器110可以监测患者的ECG以获得任何变化(例如，PQRST波中的定时变化)，同时从起始幅度值开始增加所施加信号的幅度(例如，以0.1mA的幅度开始并以增量增加幅度；例如0.1mA、0.2mA、0.5mA或1.0mA)。如方框412和414所示，只要在ECG上没有检测到心脏效应，从业者和/或处理器110(图2A)就可以继续增加LF校准信号的幅度。如方框412和416所示，如果从业者和/或系统处理器110在任何时刻检测到ECG的变化，则所施加信号的幅度可以停止增加，并且检测到ECG变化的幅度被自动地存储在系统存储器112中(图2A)(例如，在信号发生器102(图2A)和/或外部编程器120(图2A)内)和/或由医师手动输入。
在特定实施例中，信号传递系统101(图2A)可选地被配置为通过将HF校准信号应用于治疗部位并监测患者的ECG同时自起始幅度值增加HF校准信号的幅度来确定代表性的(例如，最大)HF信号幅度。在一些实施例中，HF校准信号具有小于或等于1/(2*(HF校准信号的频率))的脉冲宽度，并且在特定实施例中，具有从大约100纳秒到小于或等于1/(2*(HF校准信号的频率))的脉冲宽度。在其他实施例中，信号可以具有其他合适的脉冲宽度。类似于LF校准过程400，只要在ECG上没有检测到心脏效应，从业者和/或处理器110(图2A)继续增加HF校准信号的幅度。如果从业者和/或系统处理器110在任何时刻检测到ECG的变化，则所施加的HF校准信号的幅度可以停止增加，并且检测到ECG的变化的幅度被自动存储在系统存储器112中(图2A)(例如，在信号发生器102(图2A)和/或外部编程器120(图2A)内)和/或由从业者手动输入。虽然预计在LF校准信号处用于触发心脏活动所需的电能将远低于HF校准信号处所需的电能，在一些程序中，利用HF校准信号确定最大治疗幅度以验证使用LF校准信号所确定的最大治疗信号幅度可能是有利的。此外，在一些情况下，医生可以使用HF校准信号来设置HF治疗信号幅度的上限和下限。例如，在一些实施例中，HF治疗信号幅度的上限可以被设置为代表性的LF校准信号幅度加0.5*(代表性的HF校准信号幅度减去代表性的LF校准信号幅度)。在其他实施例中，医生可以将HF治疗信号幅度上限设置为0.9*(LF校准信号幅度)。
一旦确定了最大治疗信号幅度，系统101(图2A)即可以被置于活动模式(如图3所示)。在活动模式中，信号传递系统101被配置为将治疗信号施加到治疗部位。在不受理论束缚的情况下，与调节心脏迷走神经的LF信号相比，HF信号被认为具有显着改善的治疗效果，因为用于治疗性地调节迷走神经的LF信号所需的LF信号参数将是还必须激活心肌并诱导不需要的心脏效应(例如，心动过速、心动过缓等)。在一些实施例中，HF治疗信号被施加并且可以具有最大信号幅度的约90％的起始幅度(在校准模式期间确定)。在代表性实施例中，HF治疗信号是脉冲序列，其占空比从约1％开(on)到约90％开(例如，10％或约10％开、25％或约25％开、50％或约50％开、70％或约70％开等)。HF治疗信号可具有约1μs至约80μs的脉冲宽度，并且在一些实施方案中，具有约20μs至约60μs(例如，30μs、37μs、42μs等)的脉冲宽度。HF治疗信号还可具有约0μs至约50μs，或约10μs至约40μs的脉冲间宽度。在其他实施例中，HF治疗信号可以是任何电荷平衡的交流波形，例如双相波形、正弦波形、方波形、三角波形、矩形波形等。在其他实施例中，治疗信号不是脉冲的，而是连续传递。在这样的实施例中，电荷平衡可以通过逐个脉冲的有源再充电来实现。如下面参考图5更详细讨论的，信号传递系统101可以基于一个或多个反馈机制和/或预设程序(例如，基于一天中的时间)来控制HF治疗信号的应用的定时。例如，系统101可以被编程为一次传递数秒、数分钟、数小时、数天、数周和/或数月的HF治疗信号。在这些和其他实施例中，信号传递系统101可以被配置为在植入时连续地施加HF治疗信号。
在治疗部位(例如，在心外膜脂肪垫处或附近)施加HF治疗信号预期在治疗部位处或附近调制一个或多个迷走神经，从而改善副交感神经张力和心脏收缩性。评估收缩性和/或治疗的功效的一种方法是测量射血分数，或每次搏动期间泵出心脏的血液百分比。射血分数的增加表明改善的收缩性，同样，射血分数的降低表明收缩性降低。在静止条件下，健康成人的平均射血分数在50％至75％之间。低于50％，患者可能会出现各种症状，包括呼吸短促、无法运动、脚部和腿部肿胀、疲劳、虚弱、心跳加快或不规律。低于30％，患者的生存质量很低，死亡可能迫在眉睫。
当信号传递系统101(图2A)处于活动模式时-无论是否施加治疗信号-治疗系统100和/或信号传递系统101可被配置为连续或间歇地通过一个或多个传感元件140(图2A)监测患者的一个或多个生理参数。在代表性实施例中，传感元件140被定位和/或以其他方式配置成感测一个或多个生理参数，当由处理器110一起分析时，该生理参数提供了射血分数的可靠的实时估计，其可以被用于调整治疗信号。这些生理参数包括收缩压、舒张压、心房间压力、流速、动脉压、心率、心室容积、心室阻抗、血氧饱和度和/或前述的任何导数。在特定实施例中，例如，系统101包括连续和/或迭代地监测心室阻抗和心率的算法，并且基于那些参数，确定心室容积随时间的变化(dVV/dt)。在另一实施例中，系统101包括配置用于超声心动图信号传输的一个或多个换能器。例如，在一些实施例中，信号传递元件104(图2A)包括压电换能器阵列，其配置成朝向心脏的一个或多个腔室发射声波，检测反射的声波，并且将反射的声波转换成信号以供处理器110(图2A)存储和/或处理。在这些和其他实施例中，系统101可以包括一个或多个换能器，其与信号传递元件104分开并且被配置成定位在心脏处和/或其他内部和/或外部解剖位置处或附近。应当理解，系统101可以包括用于确定和/或估计射血分数的多种算法。例如，在特定实施例中，系统101可包括通过监测收缩速度的变化(例如，通过引线处的加速计)来估计射血分数的算法。
图5是示出用于响应于实时射血分数反馈来调整治疗信号的定时和/或一个或多个其他参数的方法的框图500。如方框510和512所示，当信号传递系统101处于活动模式时，传感元件140(图2A)连续地或间歇地将所感测的参数值传送到系统处理器110(图2A)和/或存储器112(图2A)。处理器110可以基于所感测的参数确定射血分数测量(在本文中也称为“EF测量”)(框512)。EF测量可以是瞬时射血分数值或一组值、一段时间内的平均射血分数值，和/或前述任一个的任何导数或相关值，例如射血分数随时间的变化(dEF)/dt)(或其缺乏)和射血分数EF随时间的变化率(d2EF/dt2)(或其缺乏)。
在框514中，处理器110(图2A)将EF测量值与目标射血分数阈值(在本文中也称为“目标EF阈值”)进行比较。目标EF阈值是标准化或患者特异性射血分数度量，其表示相对于患者在治疗之前的射血分数的射血分数的改善。目标EF阈值可以是单个值或值的范围，并且可以在治疗之前确定和/或在治疗期间调整。与EF测量类似，目标EF阈值可以是瞬时射血分数值或一组值、一段时间内的平均射血分数值，和/或前述任一个的任何导数，例如射血分数随时间的变化(dEF/dt)(或缺乏)和射血分数随时间的变化率(d2EF/dt2)(或缺乏)。此外，在一些实施例中，系统101(图2A)可以在决策框514处考虑多个不同的EF测量值和/或多个不同的目标EF阈值，和/或在选择动作过程之前要求不止一个比较。
如方框530所示，如果EF测量小于目标EF阈值，则处理器110(图2A)将基于信号传递系统101(图2A)当前是否正在施加治疗信号来采取两个动作中的一个。如果EF测量值小于目标EF阈值并且信号传递系统101当前正在施加治疗信号，则治疗信号的一个或多个参数可能不足以调节副交感神经。在这种情况下(由方框544指出)，处理器110可以调整一个或多个信号参数(例如，增加治疗信号幅度和/或治疗信号的脉冲宽度)以增加治疗信号的强度。如方框540和542所示，如果已经达到最大治疗信号幅度，则处理器110将不会增加治疗信号幅度。或者，如果EF测量值小于目标EF阈值并且信号传递系统101当前未施加治疗信号，则处理器110可以启动治疗信号的施加。
如框520所示，如果EF测量值大于或等于目标EF阈值，则处理器110(图2A)将基于信号传递系统101(图2A)是否当前正在施加治疗信号来采取两个动作中的一个。如果EF测量值大于目标EF阈值并且信号传递系统101当前正在施加治疗信号，停止施加治疗信号可能是有益的(由方框526所示)，但如果EF测量值低于目标EF阈值，则继续监测射血分数。或者，如果EF测量值大于目标EF阈值并且信号传递系统101当前没有施加治疗信号，则处理器110可以继续不施加治疗信号(由方框524所示)，但是如果EF测量值低于目标EF阈值，则监测射血分数。
应当理解，在任何上述实施例中，信号传递系统101(图2A)可以测量其他参数(除了射血分数之外)并且可以附加地或替代地调整治疗信号的定时和/或信号参数，以响应于由传感元件140感测的这样的其他测量和/或任何参数。例如，信号传递系统101可以被配置为检测目标心率阈值之外的平均心率，并且例如，如果在施加治疗信号时检测到的心率大于目标心率阈值，则处理器110可以减小脉冲宽度和/或增加治疗信号的幅度，以便增加副交感神经张力。
5.0附加的实施例
在以下实施例中描述了本发明公开的技术的实施方案。根据一个示例的用于治疗患者的充血性心力衰竭的方法包括经由治疗系统向患者施加电信号，该治疗系统包括与位于患者心脏的前室间交界处或附近的迷走神经的一部分处的患者的迷走神经电连通的信号传递元件，电信号的频率为约1kHz至约100kHz。该方法还包括自动检测患者的至少一个生理参数，基于检测到的参数自动确定患者心脏的射血分数和射血分数的相关系数中的至少一个，并根据确定的射血分数自动调节施加的信号。在该方法的一些实施例中，自动调节所施加的信号包括响应于检测大于或等于目标射血分数阈值的射血分数而停止施加所施加的信号。在这些和其他实施例中，自动调节所施加的信号包括响应于检测小于目标射血分数阈值的射血分数而增加所施加信号的幅度和所施加信号的脉冲宽度中的至少一个和/或自动调节所施加的信号包括响应于检测大于或等于目标射血分数阈值的射血分数而减小所施加信号的幅度和所施加信号的脉冲宽度中的至少一个。在一些实施例中，自动检测生理参数包括自动检测患者的心率，并且自动调节所施加的信号包括响应于患者的心率的增加而增加所施加信号的幅度和所施加信号的脉冲宽度中的至少一个。此外，在该方法的至少一些实施例中，施加电信号在第一时间发生并且自动调节施加的信号包括响应于检测小于目标射血分数阈值的射血分数而在第二时间施加电信号。在特定实施例中，施加电信号包括经由定位在患者心脏的心房-心室脂肪垫处或附近的引线将信号施加到患者。在该方法的某些实施例中，施加电信号包括施加脉冲宽度小于或等于1/(2x信号频率)的信号。在进一步的实施方案中，治疗系统包括可植入的治疗系统。在其他实施例中，在更进一步的实施例中，至少一个检测到的生理参数包括患者的心率、患者的血压和患者的血流速率中的至少一个。
根据另一代表性实例的治疗患者充血性心力衰竭的方法包括将频率为约1kHz至约100kHz的电信号施加至患者心脏的心外膜脂肪垫，自动监测患者的射血分数，自动将监测的射血分数值与预定阈值进行比较，并且基于该比较，自动调节所施加的信号。在该方法的一些实施例中，自动调节所施加的信号包括响应于检测到大于或等于目标射血分数阈值的射血分数而停止施加所施加的信号。在这些和其他实施例中，自动调节所施加的信号包括响应于检测到小于目标射血分数阈值的射血分数而增加所施加信号的幅度和所施加信号的脉冲宽度中的至少一个和/或自动调节所施加的信号包括响应于检测到大于或等于目标射血分数阈值的射血分数而减少所施加信号的幅度和所施加信号的脉冲宽度中的至少一个。在该方法的特定实施例中，施加电信号在第一时间发生，并且其中自动调节施加的信号包括响应于检测到小于目标射血分数阈值的射血分数而在第二时间施加电信号。
根据本技术的用于治疗患者充血性心力衰竭的系统的又一代表性示例包括具有计算机可读存储介质的电信号发生器，以及耦接到信号发生器的可植入信号传递元件。信号发生器可以被配置成靠近患者的心外膜脂肪垫定位，并且将频率为约1kHz至约100kHz的电信号施加到心外膜脂肪垫附近和/或其内的神经组织。在该系统的一些实施例中，计算机可读存储介质具有指令，该指令在被执行时实时地确定患者心脏的射血分数并且响应于所确定的射血分数调整由信号传递元件施加的信号。在特定实施例中，该系统还包括与计算机可读存储介质通信的传感器。在至少一些这样的实施例中，传感器被配置为检测患者的生理参数，并且指令在被执行时基于该生理参数计算射血分数。在该系统的某个实施例中，信号发生器是可植入的信号发生器。在系统的进一步的实施例中，指令在被执行时并且响应于确定的射血分数大于或等于预定目标阈值而停止施加电信号。在这些和其他实施例中，指令在被执行时并且响应于确定的射血分数小于或等于预定目标阈值而开始施加电信号和/或响应于小于或等于预定目标阈值的确定的射血分数而增加电信号的幅度或脉冲宽度中的至少一个。在该系统的代表性实施例中，信号传递元件被配置成定位在患者的冠状血管内。
从前述内容可以理解，本文已经出于说明的目的描述了所公开技术的特定实施例，但是在不脱离本技术的情况下可以进行各种修改。例如，在一些实施例中，系统101(图2A)可以配置成向心脏传递起搏信号。在这样的实施例中，例如，系统101可以包括被配置成传送起搏信号和调制信号的单个信号发生器，或者系统101可以包括调制信号发生器(例如，信号发生器102(图2A)和单独的起搏信号发生器(例如，外部或可植入的))。在具有被配置成传送起搏和调制信号的单个信号发生器的那些实施例中，系统101可以包括一个或多个信号传递元件，其被配置为传递起搏信号、调制信号或两者。
在其他实施例中，可以组合或消除在特定实施例的上下文中描述的技术的某些方面。例如，在一些实施例中，信号发生器102(图2A)被配置为仅在校准模式下发送LF或HF信号，并且在其他实施例中，信号发生器102可以不包括校准模式。此外，虽然已经在那些实施例的上下文中描述了与所公开技术的某些实施例相关联的优点，但是其他实施例也可以表现出这样的优点，并且并非所有实施例都必须表现出这样的优点以落入本技术范围内。因此，本公开和相关联的技术可以包含未在此明确示出或描述的其他实施例。
在通过引用并入本文的任何材料与本公开内容冲突的情况下，以本公开内容为准。

Claims (48)

1.一种治疗患者充血性心力衰竭的方法，包括：
通过治疗系统向所述患者施加电信号，所述治疗系统包括信号传递元件，所述信号传递元件与位于所述患者的心脏的前室间交界处或附近的迷走神经的一部分处的所述患者的迷走神经电连通，所述电信号具有频率范围为约1kHz至约100kHz；
自动检测所述患者的至少一个生理参数；
基于所检测到的参数自动确定射血分数指标，所述射血分数指标是所述患者的心脏的射血分数和所述射血分数的相关系数中的至少一个；以及
基于所确定的射血分数指标自动调节所施加的信号。
2.根据权利要求1所述的方法，其中自动调节所施加的信号包括响应于检测大于或等于目标射血分数阈值的射血分数指标，停止施加所述所施加的信号。
3.根据权利要求2所述的方法，其中施加所述电信号在第一时间发生，并且其中自动调节所施加的信号包括响应于检测小于所述目标射血分数阈值的射血分数指标，在第二时间施加所述电信号。
4.根据权利要求1所述的方法，其中自动调节所施加的信号包括响应于检测小于目标射血分数阈值的射血分数指标，增加所述所施加的信号的幅度和所述所施加的信号的脉冲宽度中的至少一个。
5.根据权利要求1所述的方法，其中自动调节所施加的信号包括响应于检测大于或等于目标射血分数阈值的射血分数指标，减小所述所施加的信号的幅度和所述所施加的信号的脉冲宽度中的至少一个。
6.根据权利要求1所述的方法，其中：
自动检测生理参数包括自动检测所述患者的心率；以及
自动调节所施加的信号包括响应于所述患者的心率的增加而增加所述所施加的信号的幅度和所述所施加的信号的脉冲宽度中的至少一个。
7.根据权利要求1所述的方法，其中施加所述电信号包括经由定位在所述患者的心脏的心房-心室脂肪垫处或附近的引线将所述信号施加到所述患者。
8.根据权利要求1所述的方法，其中施加所述电信号包括施加具有脉冲宽度小于或等于1/(2x所述信号的频率)的信号。
9.根据权利要求1所述的方法，其中所述治疗系统包括可植入的治疗系统。
10.根据权利要求1所述的方法，其中所述至少一个检测到的生理参数包括所述患者的心率、所述患者的血压和所述患者的血流速率中的至少一个。
11.一种治疗患者充血性心力衰竭的方法，包括：
将电信号施加到所述患者的心脏的心外膜脂肪垫上，所施加的信号具有约1kHz至约100kHz的频率；
自动监测所述患者的射血分数；
自动将所监测的射血分数值与预定的阈值进行比较；以及
根据所述比较自动调整所述所施加的信号。
12.根据权利要求11所述的方法，其中自动调节所施加的信号包括响应于检测大于或等于目标射血分数阈值的射血分数，停止施加所述所施加的信号。
13.根据权利要求12所述的方法，其中施加所述电信号在第一时间发生，并且其中自动调节所施加的信号包括响应于检测小于所述目标射血分数阈值的射血分数，在第二时间施加所述电信号。
14.根据权利要求11所述的方法，其中自动调节所施加的信号包括响应于检测小于目标射出分数阈值的射血分数，增加所述所施加的信号的幅度和所述所施加的信号的脉冲宽度中的至少一个。
15.根据权利要求11所述的方法，其中自动调节所施加的信号包括响应于检测大于或等于目标射血分数阈值的射血分数，减小所述所施加的信号的幅度和所述所施加的信号的脉冲宽度中的至少一个。
16.一种治疗患者充血性心力衰竭的系统，包括：
电信号发生器，其具有计算机可读存储介质；
被耦接到所述信号发生器的可植入信号传递元件，其中所述信号传递元件被配置成靠近所述患者的心外膜脂肪垫定位并且将频率在约1kHz到约100kHz范围内的电信号施加到靠近和/或在所述心外膜脂肪垫内的神经组织；以及
其中所述计算机可读存储介质具有指令，所述指令在被执行时：
实时确定所述患者的心脏的射血分数和所述射血分数的相关系数中的至少一个；以及
响应于所确定的射血分数调节由所述信号传递元件施加的所述信号。
17.根据权利要求16所述的系统，还包括与所述计算机可读存储介质通信的传感器，其中所述传感器被配置为检测所述患者的生理参数，并且其中所述指令在被执行时基于所述生理参数计算所述射血分数。
18.根据权利要求16所述的系统，其中所述信号发生器是可植入的信号发生器。
19.根据权利要求16所述的系统，所述指令在被执行时，并且响应于确定的射血分数大于或等于预定目标阈值，停止施加所述电信号。
20.根据权利要求16所述的系统，其中所述指令在被执行时，并且响应于确定的射血分数小于或等于预定目标阈值，开始施加所述电信号。
21.根据权利要求16所述的系统，其中所述指令在被执行时，并且响应于确定的射血分数小于或等于预定目标阈值，增加所述电信号的幅度或脉冲宽度中的至少一个。
22.根据权利要求16所述的系统，其中所述信号传递元件被配置为定位在所述患者的冠状血管内。
23.一种治疗患者充血性心力衰竭的方法，包括：
通过治疗系统向所述患者施加电信号，所述治疗系统包括位于所述患者的心脏的心外膜脂肪垫处的信号传递元件，所述电信号的频率范围为约1kHz至约100kHz；
通过一个或多个传感元件自动检测所述患者的至少一个生理参数；
基于所检测到的参数，自动确定射血分数指标，所述射血分数指标是所述患者的心脏的射血分数和所述射血分数的相关系数中的至少一个；以及
基于所确定的射血分数指标自动调节所施加的信号。
24.根据权利要求23所述的方法，其中自动调节所施加的信号包括响应于检测大于或等于目标射血分数阈值的射血分数指标，停止施加所述所施加的信号。
25.根据权利要求23所述的方法，其中施加所述电信号在第一时间发生，并且其中自动调节所施加的信号包括响应于检测小于所述目标射血分数阈值的所述射血分数指标，在第二时间施加所述电信号。
26.根据权利要求23所述的方法，其中自动调节所施加的信号包括响应于检测小于目标射血分数阈值的射血分数指标，增加所述所施加的信号的幅度和所述所施加的信号的脉冲宽度中的至少一个。
27.根据权利要求23所述的方法，其中自动调整所施加的信号包括响应于检测大于或等于目标射血分数阈值的射血分数，减小所述所施加的信号的幅度和所述所施加的信号的脉冲宽度中的至少一个。
28.根据权利要求23所述的方法，其中：
自动检测生理参数包括自动检测所述患者的心率；以及
自动调节所施加的信号包括响应于所述患者的心率的增加而增加所述所施加的信号的幅度和所述所施加的信号的脉冲宽度中的至少一个。
29.根据权利要求23所述的方法，其中施加所述电信号包括经由定位在所述患者的心脏的心房-心室脂肪垫处或附近的引线将所述信号施加到所述患者。
30.根据权利要求23所述的方法，其中施加所述电信号包括施加具有脉冲宽度小于或等于1/(2x所述信号的频率)的信号。
31.根据权利要求23所述的方法，其中所述治疗系统包括可植入的治疗系统。
32.根据权利要求23所述的方法，其中所述至少一个检测到的生理参数包括所述患者的心率、所述患者的血压和所述患者的血流速率中的至少一个。
33.一种治疗患者充血性心力衰竭的系统，包括：
可植入的电信号发生器，其具有计算机可读存储介质；
被耦接到所述信号发生器的可植入的信号传递元件，其中所述信号传递元件被配置成定位在位于所述患者的心脏的心室间连接处或附近的迷走神经的一部分处的所述患者的迷走神经处或其附近，并且其中所述信号传递元件被配置为将频率在约1kHz至约100kHz范围内的电信号施加到所述迷走神经的所述一部分附近的神经组织；以及
其中所述计算机可读存储介质具有指令，所述指令在执行时：确定射血分数指标，所述射血分数指标是所述患者的心脏的射血分数和所述射血分数的相关系数中的至少一个；以及
响应于所确定的射血分数指标调节由所述信号传递元件施加的所述信号。
34.根据权利要求33所述的系统，还包括与所述计算机可读存储介质通信的传感器，其中所述传感器被配置为检测所述患者的生理参数，并且其中所述指令在被执行时基于所述生理参数计算所述射血分数指标。
35.根据权利要求33所述的系统，其中所述指令在被执行时，并且响应于大于或等于预定目标阈值的所确定的射血分数指标，停止施加所述电信号。
36.根据权利要求33所述的系统，其中所述指令在被执行时并且响应于所确定的射血分数指标小于或等于预定目标阈值，开始施加所述电信号。
37.根据权利要求33所述的系统，其中所述指令在被执行时，并且响应于所确定的射血分数指标小于或等于预定目标阈值，增加所述电信号的幅度或脉冲宽度中的至少一个。
38.根据权利要求33所述的系统，其中所述信号传递元件被配置成定位在所述患者的冠状血管内。
39.一种治疗患者充血性心力衰竭的系统，包括：
可植入的电信号发生器，其具有计算机可读存储介质；
被耦接到所述信号发生器的可植入的信号传递元件，其中所述信号传递元件被配置成至少部分地定位在所述患者的心脏的冠状窦内，并且其中所述信号传递元件被配置为施加具有频率约1kHz至约100kHz的范围内的电信号至接近所述冠状窦的神经组织；以及
其中所述计算机可读存储介质具有指令，所述指令在执行时：
确定射血分数指标，所述射血分数指标是所述患者的心脏的射血分数和所述射血分数的相关系数中的至少一个；以及
响应于所确定的射血分数指标调节由所述信号传递元件施加的所述信号。
40.根据权利要求39所述的系统，还包括与所述计算机可读存储介质通信的传感器，其中所述传感器被配置为检测所述患者的生理参数，并且其中所述指令在被执行时基于所述生理参数计算所述射血分数指标。
41.根据权利要求39所述的系统，其中所述指令在被执行时，并且响应于所确定的射血分数指标大于或等于预定目标阈值，停止施加所述电信号。
42.根据权利要求39所述的系统，其中所述指令在被执行时，并且响应于所确定的射血分数指标小于或等于预定目标阈值，开始施加所述电信号。
43.根据权利要求39所述的系统，其中所述指令在被执行时，并且响应于所确定的射血分数指标小于或等于预定目标阈值，增加所述电信号的幅度或脉冲宽度中的至少一个。
44.一种治疗患者充血性心力衰竭的方法，包括：
通过治疗系统向所述患者施加电信号，所述治疗系统包括至少部分地位于所述患者的心脏的冠状窦内的信号传递元件，所述电信号的频率范围为约1kHz至约100kHz；
通过一个或多个传感元件自动检测所述患者的至少一个生理参数；
基于检测到的参数，自动确定射血分数指标，所述射血分数指标是所述患者的心脏的射血分数和所述射血分数的相关系数中的至少一个；以及
基于所确定的射血分数指标自动调节所施加的信号。
45.根据权利要求44所述的方法，其中自动调节所施加的信号包括响应于检测大于或等于目标射血分数阈值的射血分数指标，停止施加所施加的信号。
46.根据权利要求45所述的方法，其中施加所述电信号在第一时间发生，并且其中自动调节所施加的信号包括响应于检测小于所述目标射血分数阈值的射血分数指标，在第二时间施加所述电信号。
47.根据权利要求44所述的方法，其中自动调节所施加的信号包括响应于检测小于目标射血分数阈值的射血分数指标，增加所述所施加的信号的幅度和所述所施加的信号的脉冲宽度中的至少一个。
48.根据权利要求44所述的方法，其中自动调节所施加的信号包括响应于检测到大于或等于目标射血分数阈值的射血分数指标，减小所述所施加的信号的幅度和所述所施加的信号的脉冲宽度中的至少一个。
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US20230271016A1 (en) 2023-08-31
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US20170209699A1 (en) 2017-07-27
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