CN109996585B - 具有导磁壳体和围绕该壳体设置的感应线圈的植入式医疗设备 - Google Patents

具有导磁壳体和围绕该壳体设置的感应线圈的植入式医疗设备 Download PDF

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CN109996585B
CN109996585B CN201780071745.9A CN201780071745A CN109996585B CN 109996585 B CN109996585 B CN 109996585B CN 201780071745 A CN201780071745 A CN 201780071745A CN 109996585 B CN109996585 B CN 109996585B
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威廉姆·J·林德
基思·R·迈莱
布兰登·厄尔利·库普
迈克尔·J·鲁特
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Abstract

一种具有用于无线通信和/或功率传输的感应线圈的植入式医疗设备(IMD)。感应线圈可以围绕IMD的壳体设置。壳体可以包括导磁材料,该导磁材料被配置为操作为通量集中器,以用于集中通过感应线圈的非辐射近场能量。在一些情况下,可以捕获近场能量并将其转换成可以被用于对IMD的可再充电电源进行再充电的电能。

Description

具有导磁壳体和围绕该壳体设置的感应线圈的植入式医疗 设备
相关申请的交叉引用
本申请要求于2016年11月21日提交的美国临时专利申请序列号62/424,896的权益,其公开内容通过引用并入本文。
技术领域
本公开一般涉及植入式医疗设备,并且更具体地涉及具有用于无线通信和/或功率传输的感应线圈的植入式医疗设备。
背景技术
植入式医疗设备通常用于执行各种功能,诸如监视一个或多个状况和/或向患者递送治疗。例如,植入式医疗设备可以向患者递送神经刺激治疗。在另一示例中,植入式医疗设备可以简单地监视一个或多个状况(诸如压力、加速度、心脏事件),并且可以将检测到的状况或事件传送到另一设备,诸如另一个植入式医疗设备或外部编程器。
在一些情况下,植入式医疗设备可以被配置为向患者递送起搏和/或除颤治疗。这样的植入式医疗设备可以治疗患有可导致心脏向患者的身体递送足够量的血液的能力降低的各种心脏病的患者。在一些情况下,心脏病可能导致快速的、不规则的和/或低效率的心脏收缩。为了帮助减轻这些病症中的一些,通常将各种设备(例如,起搏器、除颤器等)植入在患者的身体中。当如此提供时,这样的设备可以进行监视并向患者的心脏提供诸如电刺激治疗的治疗,以帮助心脏以更正常的、有效率的和/或安全的方式运转。对于一些病症,患者可以具有多个植入的设备,其协作以进行监视和/或向患者的心脏提供治疗。
许多植入式医疗设备的尺寸在解剖学上受到限制。例如,无引线心脏起搏器通常放置在心脏腔室内。由于它们的尺寸相对较小,并且由于其较长的预期寿命,这种植入式医疗设备的大部分内部空间通常由电池或其他电源消耗。由于电池寿命决定了植入式医疗设备的预期使用寿命,因此期望在可用空间的限制内使电池尽可能大。
减小电源尺寸的一种方法是提供远程电池再充电能力,以对植入式医疗设备的可再充电电源进行再充电。这可以使植入式医疗设备具有更长的预期使用寿命和/或可能不需要那么多的电池空间从而允许显著更小的设备尺寸。较小的设备尺寸可以使设备更容易地可递送和可植入体内,允许设备可植入体内更小且更受限的空间中,和/或可以使设备生产成本更低。
为了帮助减小电源的尺寸,植入式医疗设备可以携带感应线圈,以用于从位于身体外部的远程功率发射器无线地接收功率。接收到的功率可以被用于对植入式医疗设备的可再充电电源进行再充电。感应线圈还可以被用于与远程设备的感应通信。使用感应线圈可以使植入式医疗设备具有有效的更长的预期使用寿命和/或可以不需要那么多的电池空间,从而允许显著更小的设备尺寸。较小的设备尺寸可以使设备更容易地可递送和可植入体内,允许设备可植入体内更小且更受限的空间中,和/或可以使设备生产成本更低。
一些植入式医疗设备的相对小的设备尺寸会对感应线圈的尺寸施加显著的限制。较小的感应线圈可以降低感应能量传输到线圈的峰值功率和效率,这是因为耦合减少并且线圈的Q因子减小。所期望的是,具有下述感应线圈的相对小的植入式医疗设备,所述感应线圈具有增加的耦合因子和/或增加的Q因子,以用于更好地传输感应能量来对可再充电电源进行再充电和/或用于更好地与远程设备进行通信。
发明内容
本公开一般涉及植入式医疗设备,并且更具体地涉及具有用于无线通信和/或功率传输的感应线圈的植入式医疗设备。虽然无引线心脏起搏器被用作植入式医疗设备的示例,但应理解,本公开可应用于任何适合的植入式医疗设备,包括例如:神经刺激器、包括那些不递送治疗的诊断设备、和/或任何其他根据需要的适合的植入式医疗设备。
在一些情况下,本公开涉及诸如无引线心脏起搏器(LCP)的植入式医疗设备(IMD),其包括可再充电电源(诸如可再充电电池、可再充电电容器或可再充电超级电容器)。在一个示例中,IMD的壳体可以包括或可以支撑导磁材料(magnetically permeablematerial)。IMD可以包括围绕壳体的一部分设置的接收线圈,并且导磁材料可以被配置为操作为通量集中器,以用于集中通过接收线圈的非辐射近场能量。然后近场能量可以被捕获并被转换成可以被用于对可再充电电源进行再充电的电能。因此,由于可再充电电源不必在IMD的整个预期寿命内在单次充电中保持足够的能量存储,因此可以在仍满足设备寿命要求的同时使电源本身以及因此IMD更小。在一些情况下,代替对可再充电电源进行再充电或者除了对可再充电电源进行充电之外,接收线圈可以被用于与远程定位的设备通信。
在本公开的另一个示例中,植入式医疗设备(IMD)可以被配置为植入患者体内,并且可以包括可以被配置用于经导管部署的壳体,并且可以包括具有大于10的相对导磁率(μr)的导磁材料。多个电极可以被暴露在壳体的外部。治疗电路可以被设置在壳体内并且可以可操作地连接到多个电极,并且可以被配置为经由多个电极中的一个或多个感测一个或多个信号和/或经由多个电极中的一个或多个电极刺激组织。可再充电电源可以被设置在壳体内,并且可以被配置为为治疗电路供电。接收线圈可以围绕包括导磁材料的壳体的部分设置,并且壳体的导磁材料可以被配置为操作为通量集中器,以用于集中通过接收线圈的非辐射近场能量。充电电路可以被设置在壳体内,并且可以与接收线圈和可再充电电源可操作地耦合,并且可以被配置为使用经由接收线圈接收到的非辐射近场能量来对可再充电电源进行充电。
作为上述任何实施例的替代或补充,IMD还可以包括一个或多个馈通件,其可以从壳体的外部延伸到壳体的内部,并且可以电连接接收线圈和充电电路。
作为上述实施例中的任一个的替代或补充,IMD还可以包括一个或多个馈通件,其可以从壳体的外部延伸到壳体的内部,并且可以将多个电极中的一个或多个电连接到治疗电路。
作为上述任何实施例的替代或补充,IMD还可以包括在接收线圈上的保护层。
作为上述任何实施例的替代或补充,保护层可以在接收线圈上提供密闭地密封。
作为上述任何实施例的替代或补充,保护层可以包括玻璃。
作为上述任何实施例的替代或补充,导磁材料可以具有小于1E-4ohm-1cm-1的电导率(σ)。
作为上述任何实施例的替代或补充,导磁材料可以包括铁氧体。
作为上述任何实施例的替代或补充,导磁材料可以包括合金。
作为上述任何实施例的替代或补充,合金可以包括高导磁合金。
作为上述任一实施例的替代或补充,壳体可以包括聚合物基部,其中导磁材料可相对于聚合物基部固定。
作为上述任何实施例的替代或补充,壳体的该部分本身可由导磁材料形成。
作为上述任何实施例的替代或补充,壳体的一部分可以包括非磁性材料,其具有管状形式,并且导磁材料可以包括嵌入壳体的该部分中的成形条带。作为上述任何实施例的替代或补充,接收线圈可以印刷在壳体的一部分上。
作为上述任何实施例的替代或补充,设置在壳体内的可再充电电源可以包括具有可以大于10的相对导磁率(μr)的导磁材料。
在本公开的另一个示例中,植入式医疗设备(IMD)可以被配置为植入患者体内,并且包括可以被配置用于经导管部署的壳体,并且可以具有管状壳体部分,该管状壳体部分可以包括具有可以大于10的相对导磁率(μr)的导磁材料。接收线圈可以围绕管状壳体部分的至少一部分设置,并且管状壳体部分的导磁材料可以被配置为操作为通量集中器,以用于集中通过接收线圈的非辐射近场能量。操作电路可以被设置在壳体内。可再充电电源可以被设置在壳体内,并且可以被配置为为操作电路供电。充电电路可以与接收线圈和可再充电电源可操作地耦合,并且可以被配置为使用经由接收线圈接收到的非辐射近场能量来对可再充电电源进行充电。
作为上述任何实施例的替代或补充,IMD还可以包括一个或多个馈通件,其可以从壳体的外部延伸到壳体的内部,并且可以连接接收线圈和充电电路。
作为上述任何实施例的替代或补充,接收线圈可以通过保护层密闭地密封。
在本公开的另一个示例中,植入式医疗设备(IMD)可以被配置为植入患者体内,并且包括可以被配置用于经导管部署的壳体,并且可以包括具有可以大于10的相对导磁率(μr)的导磁材料。线圈可以围绕壳体的导磁材料的至少一部分设置,并且导磁材料可以被配置为操作为通量集中器,以用于集中通过线圈的非辐射近场能量。通信电路可以被设置在壳体内,并且可以可操作地耦合到线圈,以通过将通信信号驱动到线圈上而经由线圈将消息发送到外部接收器。可再充电电源可以被设置在壳体内并被配置为为通信电路供电。充电电路可以与线圈和可再充电电源可操作地耦合,并且可以被配置为使用由外部电源发射并经由线圈接收到的非辐射近场能量来对可再充电电源进行充电。
作为上述任何实施例的替代或补充,IMD可以是无引线心脏起搏器。
附图说明
结合附图考虑以下描述可以更全面地理解本公开,其中:
图1是根据本公开的示例的说明性LCP的示意性框图;
图2是可以与图1的LCP结合使用的另一个说明性医疗设备的示意性框图;
图3是包括彼此通信的多个LCP和/或其他设备的示例性医疗***的示意图;
图4是根据本公开的示例的包括LCP和另一医疗设备的***的示意图;
图5是说明性植入式无引线心脏设备的侧视图;
图6是具有可再充电的植入式医疗设备***的患者的示意图;
图7是耦合的感应器***的说明性电路的示意图;
图8A-8B提供了近场能量传输***的说明性但非限制性的示例;
图9提供了根据本公开的示例的IMD内的组件中的至少一些的说明性但非限制性示例;
图10提供了根据本公开的示例的IMD内的组件中的至少一些的另一说明性但非限制性示例;
图11提供了根据本公开的示例的IMD内的组件中的至少一些的另一说明性但非限制性示例;
图12A是根据本公开另一示例的说明性IMD的示意性局部截面图;
图12B是植入患者体内的图12A的IMD和将非辐射近场能量传输到IMD的接收线圈的发射器线圈的示意图;
图13A是根据本公开另一示例的说明性IMD的示意性局部截面图;并且
图13B是植入患者体内的图13A的IMD和将非辐射近场能量传输到IMD的接收线圈的发射器线圈的示意图。
图14是嵌入壳体的一部分中的导磁材料的成形条带的示意图。
虽然本公开顺应于各种修改和替代形式,但是其细节已经通过附图中的示例被示出并且将被详细描述。然而,应当理解,意图不是将本公开限制于描述的特定实施例。相反,意图是涵盖落入本公开的精神和范围内的所有修改、等同物和替代方案。
具体实施方式
对于以下定义的术语,除非在权利要求或本说明书中其他地方给出了不同的定义,否则应当应用这些定义。
本文假设所有数值均由术语“约”修饰,无论是否明确指出。术语“约”通常是指本领域技术人员认为等同于所叙述值的的数字范围(即,具有相同的功能或结果)。在许多情况下,术语“约”可以包括四舍五入到最接近的有效数字的数字。
对于以下定义的术语,除非在权利要求或本说明书中其他地方给出了不同的定义,否则应当应用这些定义。
本文假设所有数值均由术语“约”修饰,无论是否明确指出。术语“约”通常是指本领域技术人员认为等同于所叙述值的的数字范围(即,具有相同的功能或结果)。在许多情况下,术语“约”可以包括四舍五入到最接近的有效数字的数字。
由端点表述的数值范围包括该范围内的所有数字(例如,1至5包括1、1.5、2、2.75、3、3.80、4和5)。
如在本说明书和所附权利要求中所使用的,除非内容另有明确规定,否则单数形式“一”、“一个”和“该”包括复数指示对象。如在本说明书和所附权利要求中所使用的,除非内容另有明确规定,否则术语“或”通常以其包括“和/或”的含义来使用。
应指出的是,本说明书中对“实施例”、“一些实施例”、“其他实施例”等的引用指示所描述的实施例可以包括一个或多个特定特征、结构和/或特性。然而,这样的叙述并不一定意味着所有实施例都包括该特定特征、结构和/或特征。此外,当结合一个实施例描述特定特征、结构和/或特性时,应当理解,除非明确说明相反的情况,否则无论是否明确描述,这些特征、结构和/或特性也都可以与其他实施例结合使用。
应当参考其中将不同附图中的类似结构相同地编号的附图来阅读以下描述。不一定按比例的附图描绘说明性实施例并不旨在限制本公开的范围。
图1描绘了示例性无引线心脏起搏器(LCP),其可被植入在患者中并且可以操作以向心脏递送适当的治疗,诸如递送抗心动过速起搏(ATP)治疗、心脏再同步治疗(CRT)、心动过缓治疗等。如在图1中可以看到的,LCP 100可以是紧凑型设备,其中所有组件容纳在壳体120内或直接在壳体120上。在一些情况下,LCP 100可以被认为是植入式医疗设备(IMD)的示例。在图1所示的示例中,LCP 100可以包括:通信模块102、脉冲发生器模块104、电感测模块106、机械感测模块108、处理模块110、电池112和电极布置114。取决于应用,LCP 100可以包括更多或更少的模块。
通信模块102可以被配置为与位于LCP 100外部的诸如传感器的设备、诸如SICD等的其他医疗设备通信。这些设备可以位于患者的身体的外部或内部。不管位置如何,外部设备(即,在LCP 100外部但不一定在患者的身体外部)可以经由通信模块102与LCP 100通信以实现一个或多个期望的功能。例如,LCP 100可以将诸如感测到的电信号、数据、指令、消息、R波检测标记等的信息通过通信模块102传送到外部医疗设备(例如,SICD和/或编程器)。外部医疗设备可以使用所传送的信号、数据、指令、消息、R波检测标记等来执行各种功能,诸如确定心律失常的发生、递送电刺激治疗、存储接收到的数据和/或执行任何其他适合的功能。LCP 100可以另外通过通信模块102从外部医疗设备接收诸如信号、数据、指令和/或消息的信息,并且LCP 100可以使用接收到的信号、数据、指令和/或消息来执行各种功能,诸如确定心律失常的发生、递送电刺激治疗、存储接收到的数据和/或执行任何其他适合的功能。通信模块102可以被配置为使用一个或多个方法来与外部设备通信。例如,通信模块102可以经由射频(RF)信号、感应式耦合、光学信号、声学信号、所传导的通信信号和/或适合于通信的任何其他信号来进行通信。
在图1所示的示例中,脉冲发生器模块104可以被电连接到电极114。在一些示例中,LCP 100可以另外包括电极114'。在这样的示例中,脉冲发生器104还可以被电连接到电极114'。脉冲发生器模块104可以被配置为生成电刺激信号。例如,脉冲发生器模块104可以经由使用存储在LCP 100内的电池112中的能量来生成和递送电刺激信号,并且经由电极114和/或电极114'来递送所生成的电刺激信号。替代地或另外地,脉冲发生器104可以包括一个或多个电容器,并且脉冲发生器104可以通过从电池112汲取能量来对一个或多个电容器进行充电。然后,脉冲发生器104可以使用一个或多个电容器的能量来经由电极114和/或电极114'递送所生成的电刺激信号。在至少一些示例中,LCP 100的脉冲发生器104可以包括切换电路,以选择性地将电极114和/或电极114'中的一个或多个连接到脉冲发生器104,以便选择脉冲发生器104使用电极114/114'(和/或其他电极)中的哪个来递送电刺激治疗。脉冲发生器模块104可以生成和递送具有特定特征或特定序列的电刺激信号,以便提供多个不同刺激治疗中的一个或多个。例如,脉冲发生器模块104可以被配置为生成电刺激信号以提供用于抵抗心动过缓、心动过速、心脏同步、心动过缓心律失常、心动过速心律失常、纤颤心律失常、心脏同步心律失常的电刺激治疗和/或产生任何其他适合的电刺激治疗。一些更常见的电刺激治疗包括抗心动过速起搏(ATP)治疗、心脏再同步治疗(CRT)和心脏复律/除颤治疗。在一些情况下,脉冲发生器104可以提供可控的脉冲能量。在一些情况下,脉冲发生器104可以允许控制器控制脉冲电压、脉冲宽度、脉冲形状或形态、和/或任何其他适合的脉冲特性。
在一些示例中,LCP 100可以包括电感测模块106,并且在一些情况下,LCP 100可以包括机械感测模块108。电感测模块106可以被配置为感测心脏的心电活动。例如,电感测模块106可以被连接到电极114/114',并且电感测模块106可以被配置为接收通过电极114/114'传导的心电信号。心电信号可以表示来自其中植入了LCP 100的腔室的局部信息。例如,如果将LCP 100植入在心脏的心室内(例如,RV、LV),则由LCP 100通过电极114/114'感测到的心电信号可以表示心室心电信号。在一些情况下,LCP 100可以被配置为检测来自其他腔室(例如远场)的心电信号,诸如来自心房的P波。
机械感测模块108可以包括一个或多个传感器,诸如加速度计、压力传感器、心音传感器、血氧传感器、化学传感器、温度传感器、流量传感器,和/或被配置为测量患者的一个或多个机械/化学参数的任何其他适合的传感器。电感测模块106和机械感测模块108两者都可以被连接到处理模块110,处理模块110可以提供表示感测到的机械参数的信号。虽然关于图1描述为单独的感测模块,但是在一些情况下,电感测模块106和机械感测模块108可以根据需要被组合成单个感测模块。
电极114/114'可以相对于壳体120被固定,但暴露于LCP 100周围的组织和/或血液。在一些情况下,电极114通常可以被布置在LCP 100的任一端部上,并且可以与模块102、104、106、108和110中的一个或多个电连通。电极114/114'可以由壳体120支撑,但是在一些示例中,电极114/114'可以通过短连接线而被连接到壳体120,使得电极114/114'不直接相对于壳体120被固定。在LCP 100包括一个或多个电极114'的示例中,电极114'在一些情况下可以被布置在LCP 100的侧面上,这可以增加电极的数量,LCP 100可以通过该电极来感测心电活动、递送电刺激和/或与外部医疗设备通信。电极114/114'可以由一个或多个生物相容的导电材料(诸如已知对于在人身体内植入是安全的各种金属或合金)构成。在一些情况下,连接到LCP 100的电极114/114'可以具有绝缘部分,该绝缘部分将电极114/114'与相邻电极、壳体120和/或LCP 100的其他部分电隔离。在一些情况下,电极114/114'中的一个或多个可以被提供在远离壳体120延伸的尾部(未示出)上。
处理模块110可以被配置为控制LCP 100的操作。例如,处理模块110可以被配置为从电感测模块106和/或机械感测模块108接收电信号。基于接收到的信号,处理模块110可以确定例如心脏H的运转中的异常。基于任何所确定的异常,处理模块110可以控制脉冲发生器模块104根据一个或多个治疗来生成和递送电刺激以治疗所确定的异常。处理模块110还可以从通信模块102接收信息。在一些示例中,处理模块110可以使用这样接收到的信息来帮助确定是否正发生异常、确定异常的类型、和/或响应于该信息采取特定行动。处理模块110可以另外控制通信模块102以向/从其他设备发送/接收信息。
在一些示例中,处理模块110可以包括预编程芯片,诸如超大规模集成(VLSI)芯片和/或专用集成电路(ASIC)。在这样的实施例中,芯片可以用控制逻辑预编程,以便控制LCP100的操作。通过使用预编程芯片,处理模块110可以使用比其他可编程电路(例如,通用可编程微处理器)更少的功率,同时仍然能够维持基本功能,从而潜在地增加LCP 100的电池寿命。在其他示例中,处理模块110可以包括可编程微处理器。这种可编程微处理器可以允许用户甚至在LCP 100植入之后修改LCP 100的控制逻辑,从而允许LCP 100比使用预编程ASIC时具有更大的柔性。在一些示例中,处理模块110还可以包括存储器,并且处理模块110可以将信息存储在存储器上并从存储器读取信息。在其他示例中,LCP 100可以包括与处理模块110通信的单独存储器(未示出),使得处理模块110可以从该单独存储器读取信息和向该单独存储器写入信息。
电池112可以向LCP 100提供用于其操作的功率。因为LCP 100是植入式设备,所以在植入后对LCP 100的触及可能受限制。因此,期望具有足够的电池容量以在诸如数天、数周、数月、数年或甚至数十年的治疗周期内递送治疗。在一些情况下,电池112可以是可再充电的电池,这可以帮助增加LCP 100的可使用寿命。在其他示例中,根据需要,电池112可以是一些其他类型的电源。在一些情况下,电池112可以是一次(不可再充电)电池(例如,FeS2)。在一些情况下,电池112可能根本不是电池,而是可以是超级电容器或其他电荷存储设备。在一些情况下,LCP 100可以包括用于接收近场能量的接收器线圈。充电电路可以与接收线圈和电池112可操作地耦合,并且可以被配置为使用经由接收线圈接收到的非辐射近场能量来对电池112进行充电。
为了将LCP 100植入患者的身体内部,操作者(例如,医师、临床医生等)可以将LCP100固定到患者心脏的心脏组织。为了便于固定,LCP 100可以包括一个或多个锚固件116。锚固件116可以包括多个固定或锚固机构中的任何一个。例如,锚固件116可以包括一个或多个销、U形钉、螺纹、螺钉、螺旋状物、尖齿等。在一些示例中,尽管未示出,锚固件116可以在其外表面上包括螺纹,其可以沿锚固件116的至少部分长度延伸。螺纹可以在心脏组织和锚固件之间提供摩擦力,以帮助将锚固件116固定在心脏组织内。在其他示例中,锚固件116可以包括其他结构,诸如倒钩、钉等,以便于与周围心脏组织接合。
图2描绘了另一个或第二医疗设备(MD)200的示例,其可以与LCP 100(图1)结合使用,以便检测和/或治疗心脏异常。在一些情况下,MD 200可以被视为IMD和/或LCP的示例。在所示的示例中,MD 200可以包括:通信模块202、脉冲发生器模块204、电感测模块206、机械感测模块208、处理模块210和电池218。这些模块中的每个可以类似于LCP 100的模块102、104、106、108和110。另外,电池218可以类似于LCP 100的电池112。然而,在一些示例中,MD 200可以在壳体220内具有更大的体积。在这样的示例中,MD 200可以包括更大的电池和/或更大的处理模块210,更大的处理模块210能够比LCP 100的处理模块110处理更复杂的操作。
虽然设想的是MD 200可以是另一个无引线设备(诸如图1所示),但在一些情况下,MD 200可以包括诸如引线212的引线。引线212可以包括在电极214和位于壳体220内的一个或多个模块之间传导电信号的电线。在一些情况下,引线212可以被连接到MD 200的壳体220并且远离MD 200的壳体220延伸。在一些示例中,引线212被植入在患者的心脏上、心脏内或心脏附近。引线212可以包括一个或多个电极214,其被定位在引线212上的不同位置处,并且在一些情况下被定位在距壳体220不同的距离处。一些引线212可以仅包括单个电极214,而其他引线212可以包括多个电极214。通常,电极214被定位在引线212上,使得当引线212被植入患者内时,电极214中的一个或多个被定位成执行期望的功能。在一些情况下,电极214中的一个或多个可以与患者的心脏组织接触。在一些情况下,电极214中的一个或多个可以被皮下定位并且在患者心脏的外部。在一些情况下,电极214可以将固有生成的电信号(例如表示固有心电活动的信号)传导到引线212。引线212可以进而将接收到的电信号传导到MD 200的模块202、204、206和208中的一个或多个。在一些情况下,MD 200可以生成电刺激信号,并且引线212可以将生成的电刺激信号传导到电极214。然后,电极214可以传导该电信号并(直接地或间接地)将该信号递送到患者的心脏。
与机械感测模块108一样,机械感测模块208可以包括或者电连接到一个或多个传感器,诸如加速度计、声学传感器、血压传感器、心音传感器、血氧传感器和/或被配置为测量心脏和/或患者的一个或多个机械/化学参数的其他传感器。在一些示例中,传感器中的一个或多个可以位于引线212上,但这不是必需的。在一些示例中,传感器中的一个或多个可以位于壳体220中。
虽然不是必需的,但在一些示例中,MD 200可以是植入式医疗设备。在这样的示例中,MD 200的壳体220可以被植入在例如患者的经胸廓区域中。壳体220通常可以包括许多已知材料中的任一个,其对于在人身体中植入是安全的并且当被植入时,可以将MD 200的各种组件与患者身体的流体和组织密闭地密封。
在一些情况下,MD 200可以是植入式心脏起搏器(ICP)。在该示例中,MD 200可以具有一个或多个引线,例如引线212,其被植入在患者的心脏上或患者的心脏内。一个或多个引线212可以包括与患者心脏的心脏组织和/或血液接触的一个或多个电极214。MD 200可以被配置为感测固有生成的心电信号,并且基于对感测到的信号的分析来确定例如一个或多个心律失常。MD 200可以被配置为经由植入在心脏内的引线212来递送CRT、ATP治疗、心动过缓治疗和/或其他治疗类型。在一些示例中,MD 200可以另外被配置为提供除颤治疗。
在一些情况下,MD 200可以是植入式心脏复律除颤器(ICD)。在这样的示例中,MD200可以包括植入在患者心脏内的一个或多个引线。MD 200还可以被配置为感测心电信号,基于感测到的信号确定快速性心律失常的发生,并且可以被配置为响应于确定快速性心律失常的发生而递送除颤治疗。在其他示例中,MD 200可以是皮下植入式心脏复律除颤器(S-ICD)。在MD 200是S-ICD的示例中,引线212中的一个可以是皮下植入的引线。在MD 200是S-ICD的至少一些示例中,MD 200可以仅包括皮下植入的单个引线,但这不是必需的。在一些情况下,一个或多个引线可以具有一个或多个电极,所述电极被皮下地放置并在胸腔的外部。在其他示例中,一个或多个引线可以具有一个或多个电极,所述电极被放置在胸腔的内部,诸如刚好在胸骨的内部但在心脏H的外部。
在一些示例中,MD 200可以不是植入式医疗设备。相反,MD 200可以是患者身体外部的设备,并且可以包括放置在患者身体上的皮肤电极。在这样的示例中,MD 200可以能够感测表面电信号(例如,由心脏生成的心电信号或由植入在患者身体内的设备生成的并通过身体传导到皮肤的电信号)。在这样的示例中,MD 200可以被配置为递送各种类型的电刺激治疗,包括例如除颤治疗。
在一些情况下,MD 200可以在患者身体外部并且可以包括发射线圈,该发射线圈被配置为将近场能量发射到植入的IMD。MD 200还可以包括用于以发射频率和发射幅度驱动发射线圈的输出驱动器。可以调谐(有时主动调谐)发射频率和/或发射幅度,以便将可接受的发射功率递送到植入的IMD的接收线圈。发射功率可以被用于对植入的IMD的电源进行再充电。
图3示出了医疗设备***和通信路径的示例,多个医疗设备302、304、306和/或310可以通过所述通信路径进行通信。在所示的示例中,医疗设备***300可以包括LCP 302和304、外部医疗设备306和其他传感器/设备310。外部设备306可以是先前关于MD 200描述的设备中的任一个。其他传感器/设备310也可以是先前关于MD 200描述的设备中的任一个。在一些情况下,其他传感器/设备310可以包括传感器(诸如加速度计、声学传感器、血压传感器等)。在一些情况下,其他传感器/设备310可以包括可被用于对***300的一个或多个设备进行编程的外部编程器设备。
***300的各种设备可以经由通信路径308进行通信。例如,LCP 302和/或304可以感测固有心电信号,并且可以经由通信路径308将这样的信号传送到***300的一个或多个其他设备302/304、306和310。在一个示例中,设备302/304中的一个或多个可以接收这样的信号,并且基于接收到的信号来确定心律失常的发生。在一些情况下,一个或多个设备302/304可以将这样的确定传送到***300的一个或多个其他设备306和310。在一些情况下,***300的设备302/304、306和310中的一个或多个可以基于所传送的心律失常的确定来采取行动(诸如通过向患者的心脏递送适合的电刺激)。设想的是,通信路径308可以使用RF信号、感应式耦合、光学信号、声学信号或适合于通信的任何其他信号进行通信。另外,在至少一些示例中,通信路径308可以包括多个信号类型。例如,其他传感器/设备310可以使用第一信号类型(例如,RF通信)与外部设备306通信,但是使用第二信号类型(例如,传导式通信)与LCP 302/304通信。此外,在一些示例中,可以限制设备之间的通信。例如,如上所述,在一些示例中,LCP 302/304可以通过其他传感器/设备310仅与外部设备306通信,其中LCP302/304将信号发射到其他传感器/设备310,并且其他传感器/设备310将接收到的信号转发到外部设备306。
在一些情况下,通信路径308可以包括传导式通信。因此,***300的设备可以具有允许这种传导式通信的组件。例如,***300的设备可以被配置为经由传送设备的一个或多个电极将传导式通信信号(例如,电流和/或电压脉冲)传送到患者的身体中,并且可以经由接收设备的一个或多个电极来接收传导式通信信号(例如,脉冲)。患者的身体可以将传导式通信信号(例如脉冲)从传送设备的一个或多个电极“传导”到***300中的接收设备的电极。在这样的示例中,所递送的传导式通信信号(例如,脉冲)可以与起搏或其他治疗信号不同。例如,***300的设备可以以幅度/脉冲宽度来递送电通信脉冲,该幅度/脉冲宽度是心脏的子捕获阈值。尽管在一些情况下,递送的电通信脉冲的幅度/脉冲宽度可能高于心脏的捕获阈值,但是可以在心脏的消隐期(blanking period)(例如不应期)期间被递送和/或可以被并入起搏脉冲或被调制到起搏脉冲上(如果需要的话)。
可以以任何适合的方式调制递送的电通信脉冲以对传送的信息进行编码。在一些情况下,通信脉冲可以是脉冲宽度调制的或者是脉冲幅度调制的。替代地或另外地,可以调制脉冲之间的时间以对所期望的信息进行编码。在一些情况下,传导式通信脉冲根据需要可以是电压脉冲、电流脉冲、双相电压脉冲、双相电流脉冲或任何其他适合的电脉冲。替代地或另外地,根据需要,通信路径308可以包括射频(RF)通信、感应通信、光通信、声学通信和/或任何其他适合的通信。
图4示出了说明性医疗设备***。在图4中,LCP 402被示出为固定到心脏410的左心室的内部,并且脉冲发生器406被示出为耦合到具有一个或多个电极408a-408c的引线412。在一些情况下,脉冲发生器406可以是皮下植入式心脏复律除颤器(S-ICD)的一部分,并且一个或多个电极408a-408c可以被皮下地定位。在一些情况下,一个或多个电极408a-408c可以被放置在胸腔内部但在心脏的外部,例如刚好在胸骨的内部。
在一些情况下,LCP 402可以与皮下植入式心脏复律除颤器(S-ICD)通信。在一些情况下,引线412和/或脉冲发生器406可以包括加速度计414,其可以例如被配置为感测可以指示心音的振动。
在一些情况下,根据需要,LCP 402可以在心脏的右心室、右心房、左心室或左心房中。在一些情况下,可以植入多于一个LCP 402。例如,一个LCP可以被植入在右心室中,并且另一个可以被植入在右心房中。在另一示例中,一个LCP可以被植入在右心室中,并且另一个可以被植入在左心室中。在又另一示例中,可以将一个LCP植入在心脏的腔室的每个中。
图5是说明性植入式无引线心脏起搏器(LCP)610的侧视图。LCP 610在形式和功能上可以与上述LCP 100类似。LCP 610可以包括上面关于上述LCP 100描述的模块和/或结构特征中的任一个。LCP 610可以包括外壳或壳体612,其具有近端端部614和远端端部616。说明性LCP 610包括:第一电极620,其相对于壳体612固定并且邻近壳体612的远端端部616定位;以及第二电极622,其相对于壳体612固定并且邻近壳体612的近端端部614定位。在一些情况下,壳体612可以包括导电材料,并且沿着其长度的一部分可以是绝缘的。沿着近端端部614的截面可以没有绝缘物,以便限定第二电极622。电极620、622可以是感测电极和/或起搏电极,以提供电治疗和/或感测能力。第一电极620可以能够抵靠心脏的心脏组织定位或者可以以其他方式接触心脏的心脏组织,而第二电极622可以与第一电极620间隔开。第一电极620和/或第二电极622可以被暴露于壳体612外部的环境(例如,暴露于血液和/或组织)。
在一些情况下,LCP 610在壳体612内可以包括脉冲发生器(例如,电路)和电源(例如,电池)以向电极620、622提供电信号,从而控制起搏电极/感测电极620、622。虽然没有明确示出,但是LCP 610还可以包括:通信模块、电感测模块、机械感测模块和/或处理模块以及相关联的电路,其在形式和功能上类似于上述的模块102、106、108、110。各种模块和电路可以被布置在壳体612内。脉冲发生器和电极620、622之间的电连接可以允许对心脏组织的电刺激和/或感测生理状况。
在所示的示例中,LCP 610包括靠近壳体612的远端端部616的固定机构624。固定机构624被配置为将LCP 610附接到心脏H的壁,或者以其他方式将LCP 610锚固到患者的解剖结构。在一些情况下,固定机构624可以包括锚固到心脏H的心脏组织中的一个或多个钩或尖齿626、或多个钩或尖齿626,以将LCP 610附接到组织壁。在其他情况下,固定机构624可以包括被配置为与心脏H的腔室内的骨小梁缠绕的一个或多个被动尖齿、或多个被动尖齿和/或被配置为拧入组织壁中以将LCP 610锚固到心脏H的螺旋固定锚固件。这些只是示例。
LCP 610还可以包括靠近壳体612的近端端部614的对接构件630。对接构件630可以被配置为便于LCP 610的递送和/或取出。例如,对接构件630可以沿着壳体612的纵轴从壳体612的近端端部614延伸。对接构件630可以包括头部632和在壳体612和头部632之间延伸的颈部634。头部632可以是相对于颈部634的扩大部分。例如,头部632距LCP 610的纵轴的径向尺寸可以大于颈部634距LCP 610的纵轴的径向尺寸。在一些情况下,对接构件630还可以包括从头部632延伸或凹入头部632内的系绳保持结构636。系绳保持结构636可以限定开口638,该开口638被配置为容纳穿过开口638的系绳或其他锚固机构。虽然保持结构636被示出为具有大体上“U形”构造,但是保持结构636可以采用任何形状,该形状提供围绕开口638的封闭周边,使得系绳可以安全且可释放地通过(例如,绕过)开口838。在一些情况下,保持结构636可以沿着颈部634延伸穿过头部632,并且到达壳体612的近端端部614或者进入壳体612的近端端部614中。对接构件630可以被配置为便于将LCP 610递送到心内部位和/或从心内部位取出LCP 610。虽然这描述了一个示例对接构件630,但是设想的是,对接构件630在被提供时可以具有任何适合的构造。
设想的是,LCP 610可以包括耦合到壳体612或形成在壳体612内的一个或多个压力传感器640,使得一个或多个压力传感器被暴露于壳体612外部的环境以测量心脏内的血压。例如,如果LCP 610被放置在左心室中,则一个或多个压力传感器640可以测量左心室内的压力。如果LCP 610被放置在心脏的另一部分(诸如心房中的一个或右心室)中,则一个或多个压力传感器可以测量心脏的该部分内的压力。一个或多个压力传感器640可以包括MEMS设备,诸如具有压力膜片和膜片上的压电电阻器的MEMS设备、压电传感器、电容器-微机械加工的超声换能器(cMUT)、冷凝器、微型压力计或适于测量心脏压力的任何其他适合的传感器。一个或多个压力传感器640可以是本文描述的机械感测模块的一部分。设想的是,从一个或多个压力传感器640获得的压力测量结果可被用于生成心动周期的压力曲线。压力读数可以与阻抗测量结果(例如,电极620和622之间的阻抗)结合以生成一个或多个心动周期的压力-阻抗环,如下面将更详细描述的。阻抗可以是腔室体积的替代,并因此压力-阻抗环可以表示心脏H的压力-体积环。
在一些实施例中,LCP 610可以被配置为测量电极620、622之间的阻抗。更一般地,可以在其他电极对(诸如上述附加电极114')之间测量阻抗。在一些情况下,可以在两个间隔开的LCP之间测量阻抗,诸如植入在心脏H的相同腔室(例如LV)内的两个LCP,或者植入在心脏H的不同腔室(例如RV和LV)中的两个LCP。LCP 610的处理模块和/或外部支持设备可以从在电极620、622(或其他电极)之间进行的心内阻抗测量结果导出心脏体积的测量值。主要由于血液的电阻率和心脏H的心脏组织的电阻率的差异,阻抗测量可以在心动周期期间变化,这是因为LCP周围的血液的体积(以及因此腔室的体积)改变。在一些情况下,心脏体积的测量值可以是相对测量值,而不是实际测量值。在一些情况下,心内阻抗可以经由校准过程(有时在一个或多个LCP的植入期间执行)而与心脏体积的实际测量值相关。在校准过程期间,可以使用荧光镜检查等确定实际心脏体积,并且可以使所测量的阻抗与实际心脏体积相关。
在一些情况下,LCP 610可以被提供有能量递送电路,其可操作地耦合到第一电极620和第二电极622,以用于使电流在第一电极620和第二电极622之间流动,以便确定两个电极620、622(或其他电极对)之间的阻抗。设想的是,能量递送电路还可以被配置为经由第一电极620和/或第二电极622来递送起搏脉冲。LCP 610还可以包括可操作地耦合到第一电极620和第二电极622的检测电路,以用于检测在第一电极620和第二电极622之间接收到的电信号。在一些情况下,检测电路可以被配置为检测在第一电极620和第二电极622之间接收到的心脏信号。
当能量递送电路在第一电极620和第二电极622之间递送电流时,检测电路可以测量第一电极620和第二电极622之间(或者与第一电极620和第二电极622分离的第三电极和第四电极之间,未示出)产生的电压,以确定阻抗。当能量递送电路在第一电极620和第二电极622之间递送电压时,检测电路可以测量第一电极620和第二电极622之间(或者与第一电极620和第二电极622分离的第三电极和第四电极之间)产生的电流,以确定阻抗。
在一些情况下,壳体612可以包括或可支撑导磁材料。接收线圈(图5中未明确示出)可以围绕壳体612的一部分设置,并且导磁材料可以被配置为操作为通量集中器,以用于集中由远程发射器射出的通过接收线圈的非辐射近场能量。近场能量可以由接收线圈捕获并且转换成电能,该电能可以被用于对壳体612内的可再充电电源进行再充电。因此,由于可再充电电源不必在LCP 610的整个预期寿命内在单次充电中保持足够的能量存储,因此可以在仍满足设备寿命要求的同时使电源本身以及因此LCP 610更小。在一些情况下,代替对可再充电电源进行再充电或者除了对可再充电电源进行充电之外,接收线圈可以被用于与远程定位的设备通信。
图6提供了患者700的高度示意性图示,患者700具有植入在患者700体内的植入式设备(IMD)702。虽然IMD 702被示出为在患者胸部中或附近,但是应当理解,这仅仅是说明性的,因为IMD 702可以根据其功能而被植入患者700内的其他位置。发射器704被示出在在患者700的外部。在一些情况下,发射器704可以被配置为发射无功近场能量,其具有在不对患者700造成过度组织加热或其他潜在破坏性影响的情况下可以安全地传输进入患者700中到达IMD 702的波长(或频率,因为波长和频率通过光的数值速度相关)和幅度。
发射器704可以采用任何适合的形式。例如,虽然在图6中被示意性地示出为盒,但是发射器704可以被定尺寸和配置为使患者700周期性地围绕其颈部佩戴系索或者放在衬衫口袋中,这将放置发射器704靠近他们的胸部,处于与患者胸腔内的IMD 702大约相同的垂直和水平位置。在一些情况下,发射器704可以被内置在椅子的后部,患者700将定期坐在椅子中以对IMD 702再充电。例如,椅子可以在患者的家中,例如用于每日充电,或者可以在诸如医疗诊所的远程位置,用于具有更长充电时间表的患者700。
作为另一个示例,发射器704可以内置在床中,使得发射器704可以在患者700每天晚上睡觉时至少部分地对IMD 702进行再充电。在一些情况下,发射器704可以被配置为根据IMD 702的功率要求而例如每周发射一次、或者每月发射一次。在一些情况下,发射器704和IMD 702可以彼此通信。当如此设置时,IMD 702可以将其当前电池再充电水平报告给发射器704,并且如果当前电池再充电水平低于阈值,则发射器704可以向IMD 702发射功率。
应当理解,IMD 702可以被配置为周期性地接收对患者700安全且IMD 702可以使用其来对IMD 702内的可再充电电源进行再充电的波长和强度的近场能量。可以以超过从可再充电电池汲取功率并且功率被IMD 702内的各种组件消耗的速率的速率接收近场能量。
图7提供了耦合感应器***800的说明性电路。感应耦合是源802和设备804之间的电能的近场无线传输。在一些情况下,源802可以通过磁场将功率从源感应器806(例如,源线圈)传输到设备感应器808(例如,设备线圈)。因此,***800可以充当变压器。在一些情况下,信号发生器810可以通过源感应器806生成交流电(AC)并产生振荡磁场。信号发生器810可以包括输出驱动器。磁场可以穿过设备感应器808并且感应交变电磁力(EMF),其在设备804中产生交流电(AC)。感应的AC可以直接驱动负载812,或者通过设备804中的整流器(未示出)整流成直流(DC),其驱动负载812。
在一些情况下,传输的功率可随着源感应器806和设备感应器808之间的频率和互感(其可取决于它们的几何形状和它们之间的距离)而增加。例如,如果源感应器806和设备感应器808在同一轴(即,主捕获轴)上并且靠近在一起,因此来自源感应器806的磁通量穿过设备感应器808,则功率的传输可以接近100%。线圈之间的间隔越大,则来自源感应器806的磁通量可能越多地错过设备感应器808,并且功率的传输可能减小。
在一些情况下,源感应器806和/或设备感应器808可以适配有磁芯。磁芯可以是一块具有高导磁率的磁活性材料,其用于限制和引导电气、机电和磁设备(诸如电磁体、变压器、发电机、感应器和其他磁组件)中的磁场。在一些情况下,磁芯可以由铁磁金属(诸如铁)或铁磁化合物(诸如铁氧体)制成。相对于周围大气的高导磁率可以致使磁场线集中在铁氧体磁芯中,并且因此可以充当磁通量集中器。在一些情况下,使用铁氧体磁芯可以使强度集中并增加源感应器806产生的磁场的影响,并且可以改善感应耦合和功率的传输。
在一些情况下,***可以实现谐振感应耦合。在这种情况下,可以将源802调谐到与设备804相同的频率谐振。在一些情况下,源802可以包括连接到电容器814的源感应器806。源感应器806和设备感应器808之间的谐振可以增加耦合和发射功率。在一些情况下,当***800实现谐振感应耦合时,源802和设备804可以比它们与非谐振物体更强地相互作用,并且可以减少由于在附近杂散物体中的吸收导致的功率损耗。
图8A-8B提供了近场能量传输***900的说明性但非限制性的示例。如图8A所示,源912可以通过源线圈916生成交流电(AC)以产生振荡磁场920。在一些情况下,磁场920可能几乎不通过或不通过接收器914的接收线圈918。例如,接收线圈918的主捕获轴的方向可以不与源线圈916的主传输轴对准,或者在一些情况下,接收线圈918和源线圈916之间可以存在相当大的距离,从而允许磁场920分散并限制行进通过接收线圈918的磁通量。当接收线圈918很小时尤其如此。
为了帮助增加接收线圈918捕获到的磁通量,接收线圈918可以围绕导磁材料922设置,诸如图8B所示。导磁材料922可以被用于集中、限制、引导、转向和/或聚焦通过接收线圈918的磁场线。在一些情况下,导磁材料922相对于周围环境的高导磁率可以通过致使磁场线集中在穿过接收线圈918的导磁材料922中而充当磁通量集中器。在一些情况下,使用导磁材料922可以改善源线圈916和接收线圈918之间的耦合,并且因此可以帮助提高整体功率传输效率。
在一些情况下,导磁材料922可以具有大于900的相对导磁率,并且可以由多种材料中的任何一种组成。例如,在一些情况下,导磁材料922可以是铁氧体,诸如铁氧体(例如,40%Fe2O3、40%MnO、920%CdO)、锰锌铁氧体(例如,MnaZn(1-a)Fe2O4)、镍锌铁氧体(例如,NiaZn(1-a)Fe2O4)、锶铁氧体(例如,SrFe912O19(SrO·6Fe2O3))、钴铁氧体(例如,CoFe2O4(CoO·Fe2O3))或钡铁氧体(例如,BaFe912O19(BaO·6Fe2O3))。铁氧体可以被用于高频应用。构成铁氧体的材料可以设计成具有宽范围的参数并且被设计为陶瓷,它们可以是绝缘体,这可以帮助减少和/或防止导磁材料922中的涡电流。
在一些情况下,导磁材料922可以是合金,诸如Alnico(例如,35%钴、34%铁、15%镍、7%铝、5%钛和4%铜)、Comol(例如,914%钼、912%钴和71%铁)、Hipernom(Ni-Mo合金)(例如,79%镍、4%钼和余量的铁)、铁硅磁合金(例如,铁与1-5%硅)、磁钢(例如,具有碳和铬含量的铁)、铬(例如,28%铬、15%钴和铁)、Silmanal(例如,6.75%银,8.8%锰和4.45%铝)、Platinax(例如,76.7%铂和23.3%钴)、Bismanol(例如,具有920.8%锰的铋锰合金)、钴-铂合金、铬-锰-锑化物(例如,CrxMn2xSb)、Ultra-mag(例如,Pt-Co磁体材料)、Vectolite(例如,铁和氧化铁与氧化钴)、Magnadur(例如,碳酸钡和氧化铁;BaO(Fe2O3)6)、Lodex(例如,具有铅粉的铁-钴)、稀土磁铁(例如,钐钴、铯-钴、钕-铁生成的磁体)、Awaruite(例如,Ni3Fe)、Wairauite(例如,CoFe)、高导磁合金、坡莫合金和超导磁合金。在一些情况下,合金可以被制造成冲压件或被制造成带缠绕芯的长带。在其他情况下,合金可以被制造成粉末并烧结成形。在某些实施例中,合金(例如,高导磁合金)的热处理可以增加其导磁率。例如,在磁场中在氢气氛中退火高导磁合金之后,高导磁合金的导磁率可以增加40倍。
在一些情况下,导磁材料922可以是金属氧化物,诸如磁铁矿(例如,Fe3O4)、钛铁尖晶石(例如,Fe2TiO2)、赤铁矿(例如,αFe2O3)、钛铁矿(例如,FeTiO2)、磁赤铁矿(例如,γFe2O3))和锰铁矿(例如,MnFe2O4)。在一些情况下,导磁材料922可以是金属硫化物,诸如磁黄铁矿(例如,Fe7S8)、硫复铁矿(例如,Fe3S4)和硫铁矿(FeS)。在一些情况下,导磁材料922可以是金属羟基氧化物,诸如针铁矿(例如,αFeOOH)、纤铁矿(例如,γFeOOH)和六方纤铁矿(例如,δFeOOH)。
在一些情况下,导磁材料922可以是金属,诸如铁(Fe)、镍(Ni)和钴(Co)。在某些实施例中,可以使用铁,这是因为它可以承受高水平的磁场而不会饱和。可以使用经退火的铁或“软”铁,这是因为它可能具有低矫顽力并且在去除磁场时可能不会保持磁化。
图9是说明性植入式医疗设备(IMD)1000的示意性框图。在一些情况下,说明性IMD1000可以包括壳体1004,其可以包括充电电路1008、可再充电电源1010和操作电路1012。IMD 1000还可以包括接收线圈1014。
在一些情况下,接收线圈1014可以是各种不同类型的线圈中的任何一种。在考虑发射线圈/天线周围的电磁区域时,存在三类;即,(1)无功近场;(2)辐射近场和(3)辐射远场。“感应”充电***在无功近场区域中操作。在感应功率***中,通常通过使用线圈(诸如接收线圈1014)之间的感应耦合的磁场或者通过使用电极之间的电容耦合的电场来在短距离上传输功率。在辐射功率***(例如辐射近场和辐射远场)中,功率通常由电磁(EM)能量束发射。辐射功率***通常可以将能量传输更长距离,但是接收天线捕获足够能量的能力可能具有挑战性,特别是对于其中接收天线大小有限的应用。
在一些情况下,发射器(例如,图6的发射器704)和IMD 1000可以在患者(例如,图6的患者700)体内感应地在大约10kHz和100MHz之间传输功率。当如此设置时,***在无功、非辐射、近场(如感应充电***)中操作。在一些情况下,发射器704可以发射近场能量,使得接收线圈1014可以捕获近场能量并将其提供给充电电路1008。在某些实施例中,接收线圈1014围绕IMD 1000的壳体1004的一部分设置。在某些实施例中,接收线圈1014可以被配置为接收近场能量。充电电路1008可以与接收线圈1014和可再充电电源1010可操作地耦合。在一些实施例中,馈通件1002、1006可以从壳体1004的外部延伸到壳体1004内部,并且可以将接收线圈1014电连接到充电电路1008。馈通件1002、1006可以是例如用于通过壳体1004承载信号的导体。
在一些情况下,充电电路1008可以被配置为使用由接收线圈1014接收到的近场能量对可再充电电源1010进行充电。在一些情况下,接收线圈1014可以被配置为从患者700(图6)外部发射的近场能量的波段接收足够的近场能量,从而在近场能量的波段以不会对患者700造成热损伤的强度发射时,以比可再充电电源1010由于为IMD 1000供电而消耗的速率更快的速率对可再充电电源1010进行再充电。在一些情况下,壳体1004具有基本上圆柱形的轮廓,或管状形式或形状,并且接收线圈1014可以符合基本上圆柱形的轮廓,或者壳体1004的外表面的管状形式或形状。
在一些情况下,充电电路1008可以被配置为将接收到的近场能量转换为可以被用于对可再充电电源1010进行再充电的形式。在一些情况下,充电电路1008可以发挥功能以对可再充电电源1010进行再充电,并且IMD 1000可以包括操作电路1012以提供属于IMD1000的其他功能。在一些情况下,充电电路1008可以直接向IMD 1000的操作电路1012提供功率。取决于应用,操作电路1012可以包括感测电路、治疗递送电路、通信电路和/或任何其他适合的电路。
可再充电电源1010可以包括任何类型的可再充电电源。在一些情况下,可再充电电源1010可以包括可再充电电池、超级电容器和/或任何其他适合的可再充电电源。可再充电电源1010可以采用三维形状,其便于将可再充电电源1010并入到IMD 1000的壳体1004中。如将理解的并且如前所述,在一些情况下,壳体1004可以具有圆柱形或基本上圆柱形的形状,或者管状或基本上管状的形状,在这种情况下,可再充电电源1010可以具有圆柱形、管状或者环形轮廓(诸如纽扣电池或具有基本上圆柱形形状或管状形状的(长度上)细长的电池),但这不是必需的。在一些情况下,可再充电电源1010可以包括一次(不可再充电)电池(例如,FeS2)和二次(可再充电)电池。在其他情况下,可再充电电源1010可以仅包括一次电池。在一些情况下,壳体1004可以是刚性的;在一些情况下,它可能是柔性的。应认识到,可再充电电池的形状和尺寸可能存在相对于性能的折衷,因此在设计用于特定用途的可再充电电源1010时应考虑这些问题。虽然图9示意性地示出了单个可再充电电源1010,但在一些情况下,可以存在两个、三个或更多个不同的可再充电电源1010,每个可再充电电源1010与充电电路1008电耦合。例如,在一些情况下,具有多个可再充电电源1010(串联或并联连接)可能具有性能优势。在一些情况下,具有多个(和更小的)可再充电电源1010可能具有封装优势。在一些情况下,可再充电电源1010可以包括一种以上类型的可再充电电源(例如,可再充电电池和超级电容器)。
在某些实施例中,壳体1004的一部分可以具有和/或可以包括导磁材料1016。在其他情况下,导磁材料1016可以固定到、嵌入壳体1004或以其他方式由壳体1004承载。在一些情况下,导磁材料1016可以固定到、嵌入壳体1004内的一个或多个组件(诸如可再充电电源1010的电池或壳体1004内的其他组件)或以其他方式由壳体1004内的一个或多个组件承载。例如,导磁材料1016可以包括有无源组件(诸如电池内的集电器)。在其他情况下,导磁材料1016可以包括有活性组分(诸如电池内的铅化合物)。在一些情况下,在电池是不可再充电电池的情况下,线圈可以被用于感应通信而不用于对电池进行再充电。当这样设置时,电池中的导磁材料1016可以帮助引导磁通量通过线圈,这可以帮助提高感应通信效率。
根据各种实施例,导磁材料1016及其位置、形状和取向可以被布置为集中、限制、引导,转向和/或聚焦通过接收线圈1014的磁场。在一些情况下,导磁材料1016相对于周围环境的导磁率(例如,大于10、100、1000、10000或更多的相对导磁率(μr))可有助于将磁通集中在导磁材料1016中,其可以穿过接收线圈1014。在一些情况下,使用导磁材料1016可以帮助改善发射器线圈和接收线圈1014之间的感应耦合,并因此提高对可再充电电源1010的总功率传输效率。
图10是另一示例性植入式医疗设备(IMD)1100的示意性框图。IMD 1100及其组件的配置和操作可以类似于图9的IMD 1000的配置和操作。在一些情况下,如图10中看到的,IMD 1100可以包括通信电路1110。在某些实施例中,通信电路1110可以可操作地耦合到线圈1112,并且可以提供通信路径以将消息发射到外部接收器(未示出)、设备(诸如位于IMD1100外部的传感器、其他医疗设备等)。这些设备可位于患者700(图6)身体的外部或内部。不管位置如何,外部设备(即,IMD 1100外部但不一定在患者700身体外部)可以经由通信电路1110与IMD 1100通信以实现一个或多个期望的功能。通信电路1110可以被配置为使用一种或多种方法与外部接收器通信。例如,通信电路1110可以经由射频(RF)信号、感应式耦合、光学信号、声学信号、所传导的通信信号和/或适合于通信的任何其他信号来进行通信。
在一些情况下,电极1102a和1102b可以暴露在壳体1104的外部,并且可以可操作地耦合到设置在壳体1104内的通信电路1110。在一些情况下,通信电路1110可以被配置为使用经由电极1102a和1102b的传导式通信与一个或多个外部设备(例如,外部接收器)通信。替代地或另外地,IMD 1100的通信电路1110可以被配置为使用经由线圈1112的感应通信与一个或多个外部设备(例如,外部接收器)通信。
在一些情况下,IMD 1100可以通过通信电路1110将信息(诸如感测到的电信号、数据、指令、消息、R波检测标记等)传送到外部接收器。IMD 1100还可以通过通信电路1110从外部接收器接收信息(诸如信号、数据、指令和/或消息),并且IMD 1100可以使用接收到的信号、数据、指令和/或消息来执行各种功能(诸如对可再充电电源1108进行充电、存储接收到的数据和/或执行任何其他适合的功能)。
在一些情况下,通信电路1110可以使用利用近场能量的感应通信模式在IMD 1100和外部接收器之间建立通信路径。近场通信是使用近场磁通量进行数据传输的无线形式的短距离通信。例如,在一些实施例中,当外部接收器未被用于传输电能以对IMD 1100的可再充电电源1108进行再充电时,可以提供感应通信链路。例如,通信电路1110可以被配置为当可再充电电源1108当前处于半充电状态或低于半充电状态时向外部接收器发送警报。在这种情况下,通信电路1110可以将通信信号(例如,AC信号)驱动到线圈1112上,以指示可再充电电源1108处于或低于半充电状态。然后,通信信号可以产生振荡磁场,该振荡磁场可以穿过外部接收器线圈并感应EMF。然后,EMF可以在外部接收器中创建AC信号,并且外部接收器可以解译AC信号。在某些实施例中,外部接收器可以包括具有照明设备(诸如LED)或音频设备(诸如扬声器)的用户界面(未示出),以响应于解译AC信号而显示或发出人类可感知的警报。例如,LED可以被点亮和/或扬声器可以释放指示IMD 1100处于或低于半充电状态的“嗡嗡”声。患者700可以观察LED的照明和/或听到来自扬声器的“嗡嗡声”并使用外部接收器来发射电能以对IMD 1100的可再充电电源1108进行再充电。在一些情况下,外部接收器可以向患者的移动电话或其他设备发送消息以警告患者。
在某些实施例中,可再充电电源1108可以仅包括一次(不可再充电)电池(例如,FeS2),并且导磁材料1114可以具有电池内的无源或有源组件。在这种情况下,线圈1112可以仅被配置为与外部接收器或另一外部设备(例如,患者的移动电话、网络通信设备、数据库等)建立感应通信链路。
在另一个实施例中,当外部接收器用于传输电能以对IMD 1100的可再充电电源1108进行再充电时,可以提供感应通信链路。在这种情况下,外部接收器可以生成交流电(AC)并经由线圈产生振荡磁场。磁场可以穿过IMD 1100的线圈1112并且感应EMF,其在IMD1100中产生AC。通信电路1110可以被配置为当外部接收器被认为与IMD 1100未对准时向外部接收器发送警报。例如,在一些情况下,外部接收器与IMD 1100的未对准可能致使当施加磁场并期望充电时IMD 1100未被充分充电。通信电路1110可以通过调制磁场的传输能量参数(例如,幅度、频率、相位、脉冲宽度等)将通信信号驱动到线圈1112上。然后,经调制的磁场可以通过外部接收器线圈返回并感应EMF,EMF在外部接收器中产生AC信号。然后外部接收器可以解译AC信号。响应于解译AC信号,LED可以被点亮和/或扬声器可以释放“嗡嗡”声。患者700可以观察LED的照明和/或听到来自扬声器的“嗡嗡声”并重新对准外部接收器,直到LED不再被点亮和/或扬声器停止释放“嗡嗡”声为止。在一些情况下,外部接收器可以向患者的移动电话或其他设备发送消息以警告患者。
在某些实施例中,壳体1104的一部分可以具有和/或可以包括导磁材料1114。在其他情况下,导磁材料1114可以固定到、嵌入壳体1104或以其他方式由壳体1104承载。在一些情况下,导磁材料1114可以固定到、嵌入壳体1104内的一个或多个组件(诸如可再充电电源1108的电池或壳体1104内的其他组件)或以其他方式由壳体1104内的一个或多个组件承载。导磁材料1114及其位置、形状和取向可以被用于集中、限制、引导、转向和/或聚焦通过线圈1112的磁场。在一些情况下,导磁材料1114相对于周围环境的导磁率(例如,大于10、100、1000、10000或更多的相对导磁率(μr))可以有助于将磁通量集中在导磁材料1114中,其可以穿过线圈1112。在一些情况下,使用导磁材料1114可以帮助改善发射器线圈和线圈1112之间的感应耦合,并且因此可以帮助提高对可再充电电源1108的总功率传输效率和/或提高使用线圈1112进行通信的功率效率。
图11是另一示例性植入式医疗设备(IMD)1200的示意性框图。IMD 1200及其组件的配置和操作可以类似于关于图9描述的IMD 1000及其组件的配置和操作。在一些情况下,电极1218、1220可以暴露在壳体1202的外部,并且可以可操作地耦合到设置在壳体1202内的治疗电路1212。在一些实施例中,馈通件1204、1208可以从壳体1202的外部延伸到壳体1202的内部,并且将电极1218、1220电连接到治疗电路1212。馈通件1204、1208可以是例如导体,并且可以被用于通过壳体1202承载信号。在一些情况下,导磁材料可以被用在馈通件1204、1208中。
虽然示出了两个电极,但是应当理解,在一些情况下,IMD 1200可以包括三个、四个或更多个不同的电极。取决于IMD 1200的预期功能,电极1218、1220可以被用于感测和/或起搏患者(例如,图6的患者700)的心脏。在一些情况下,IMD 1200可以是无引线心脏起搏器(LCP)、植入式监测设备或植入式传感器。在一些情况下,类似于上面的电极1102a和1102b,电极1218、1220可以被用于与其他植入设备和/或与外部设备通信。在一些情况下,与其他植入设备的通信可以包括传导式通信,但这只是一个示例。
在一些情况下,充电电路1206和治疗电路1212可以位于不同的电路板上或者可以显现在不同的集成电路(IC)内。在一些情况下,充电电路1206和治疗电路1212虽然被示为不同的元件,但可以被组合在单个IC内或单个电路板上。在一些情况下,治疗电路1212可以可操作地耦合到电极1218、1220。在一些情况下,治疗电路1212可以被配置为经由电极1218、1220(或附加电极)感测一个或多个信号和/或经由电极1218、1220刺激组织。在一些情况下,治疗电路1212可以至少部分地响应于一个或多个感测信号来起搏或刺激组织。
在某些实施例中,壳体1202的一部分可以具有和/或可以包括导磁材料1216。在其他情况下,导磁材料1216可以固定到、嵌入壳体1202或以其他方式由壳体1202承载。在一些情况下,导磁材料1216可以固定到、嵌入壳体1202内的一个或多个组件(诸如可再充电电源1210的电池或壳体1202内的其他组件)或以其他方式由壳体1202内的一个或多个组件承载。导磁材料1216及其位置、形状和取向可以被用于集中、限制、引导、转向和/或聚焦通过围绕壳体缠绕的线圈1214的磁场。在一些情况下,导磁材料1216相对于周围环境的导磁率(例如,大于10、100、1000、10000或更多的相对导磁率(μr))可以有助于将磁通量集中在导磁材料1216中,其可以穿过线圈1214。在一些情况下,使用导磁材料1216可以帮助改善发射器线圈和线圈1214之间的感应耦合,并且因此可以帮助提高对可再充电电源1210的总功率传输效率和/或提高使用线圈1214进行通信的功率效率。
图12A-12B提供了说明性IMD 1300的示意图,其可被配置为植入患者(诸如患者700(图6))体内。参照图12A,在一些情况下,说明性IMD 1300可以包括电极1314、1316,其可以暴露在壳体1310的外部,并且可以可操作地耦合到设置在壳体1310内的控制器1304。控制器1304可以包括例如处理器、状态机和/或其他适合的电路。在一些实施例中,一个或多个馈通件1302、1306可以从壳体1310的外部延伸到壳体1310的内部,并且可以将电极1314、1316电连接到控制器1304。在一些情况下,导磁部分1326可以被用在馈通件1302、1306中,但这不是必需的。
虽然示出了两个电极,但是应当理解,在一些情况下,IMD 1300可以包括三个、四个或更多个不同的电极。取决于IMD 1300的预期功能,电极1314、1316可以被用于感测和/或起搏患者的13000心脏。替代地或另外地,电极1314、1316可以被用于与其他植入设备和/或与外部设备通信。在一些情况下,与其他植入设备的通信可以包括传导式通信,但这不是必需的。可再充电电源1308可以被设置在壳体1310内,并且可以被配置为为IMD 1300(包括控制器1304)供电。在一些情况下,IMD 1300可以是无引线心脏起搏器(LCP)、植入式监测设备或植入式传感器。
在各种实施例中,IMD 1300可以包括感应线圈1312。在某些实施例中,感应线圈1312可以在壳体1310的外部并且围绕壳体1310的部分1326设置。设想的是,感应线圈1312可以是各种不同类型的线圈中的任何一种。在一些情况下,外部接收器(例如,图12B的外部收发器1330)可以将患者13000体内的大约10kHz和100MHz之间的功率感应地传输到IMD1300的感应线圈1312。设想的是,***可以在无功、非辐射、近场(如感应充电***)中操作。在一些情况下,外部收发器1330可以发射近场能量,使得IMD 1300的感应线圈1312可以捕获近场能量并将其提供给控制器1304。在一些实施例中,馈通件1318、1320可以从壳体1310的外部延伸到壳体1310的内部,并且可以将感应线圈1312电连接到控制器1304。馈通件1318、1320可以是用于通过壳体1310承载信号的导体。
感应线圈1312可以被配置为从发射自患者700外部的近场能量的波段接收足够的近场能量,并且将接收到的近场能量转换成可以被用于对可再充电电源1308进行再充电的形式和/或提高通信的功率效率。在各种实施例中,在近场能量的波段以不对患者700造成热损伤的强度发射时,可再充电电源1308被充电的速率可以处于比可再充电电源1308由于为IMD 1300供电而消耗的速率更快的速率。在一些情况下,壳体1310可以具有基本上圆柱形的轮廓或管状形式,并且感应线圈1312可以围绕壳体1310的部分1326缠绕、印刷在壳体1310的部分1326上和/或由壳体1310的部分1326承载。在一些情况下,感应线圈1312可以具有围绕壳体1310的部分1326缠绕的多个层。
在某些实施例中,承载感应线圈1312的壳体1310的部分1326本身可由导磁材料构成或包括导磁材料。在其他情况下,导磁材料可以固定到、嵌入壳体1310或以其他方式由壳体1310承载。例如,参照图14,导磁材料1500被示出为为嵌入壳体1502的一部分中的成形条带。在各种实施例中,壳体1502的一部分可由非磁性材料构成,该非磁性材料可以包括但不限于金属(例如,铝、铜、铅、镍、锡、钛和锌)、合金(例如,黄铜)、贵金属(例如,金、银和铂)以及稀有金属(例如,钴、汞、钨、铍、铋、铈、镉、铌、铟、镓、锗、锂、硒、钽、碲、钒和锆)。在一些情况下,壳体1502的非磁性部分可有利于限制不期望的制造质量,如果壳体的整个部分由导磁材料构成,则可能产生上述不期望的制造质量。
再次参照图12A,在一些情况下,导磁材料可以固定到、嵌入壳体1310内的一个或多个组件(诸如可再充电电源1308的电池或壳体1310内的其他组件)或以其他方式由壳体1310内的一个或多个组件承载。在某些实施例中,导磁材料可以用作电池活性材料,诸如LiFePO4、LiCoO2、LiNi0.33Mn0.33Co0.33O2(NMC)、LiNi0.8Co0.15Al0.05(NCA)和/或任何其他适合的材料。在某些实施例中,导磁材料可以分布在整个可再充电电源1308中。在一些情况下,导磁材料可以是铁氧体或金属氧化物,并且可以添加到可再充电电源1308的阴极材料中。在一些情况下,导磁材料可以是金属或金属合金,并且可以添加到可再充电电源1308的阴极或阳极材料中。在任何情况下,导磁材料及其位置、形状和/或取向可以被布置为集中、限制、引导、转向和/或聚焦通过感应线圈1312的磁场。在一些情况下,导磁材料相对于周围环境的导磁率(例如,大于10、100、1000、10000或更多的相对导磁率(μr))可有助于将磁通量集中在导磁材料中,其可以穿过感应线圈1312。在一些情况下,使用导磁材料可以帮助改善发射器线圈1328和感应线圈1312之间的感应耦合,并因此提高对IMD 1300的总功率传输效率。
参照图12B并如本文所讨论的,导磁材料可以被用于集中、限制、引导、转向和/或聚焦通过IMD 1300的感应线圈1312的磁场1332。在一些情况下,导磁材料相对于周围环境的高导磁率可以充当磁通量集中器,并且可以致使磁场线1332弯曲并集中在导磁材料部分1326中,其可以穿过感应线圈1312。
在一些情况下,导磁材料部分1326可以具有大于10、100、1000、10000或更大的相对导磁率(μr)。导磁材料部分1326可以包括各种不同的材料。例如,在一些情况下,导磁材料部分1326可以是铁氧体、合金(例如,高导磁合金)、金属氧化物、金属硫化物、金属羟基氧化物或金属。这些只是示例。在一些情况下,导磁材料部分1326可以具有小于1E-4ohm-1cm-1的电导率(σ)。在一些情况下,导磁材料部分1326可以具有圆柱形或基本上圆柱形的形状,或者管状或基本上管状的形状或形式。在一些情况下,壳体1310本身可以由导磁材料构成。在一些情况下,导磁材料部分1326可以具有基板或基部(诸如聚合物基板或基部),其中导磁材料被附接、嵌入、设置在基板或基部上或以其他方式由基板或基部承载。替代地或另外地,壳体1310本身或其一部分(诸如部分1326)可由导磁材料形成。
再次参照图12A,根据各种实施例,可以在感应线圈1312上提供保护层1324。在某些实施例中,感应线圈1312可以由生物相容的保护层1324密封。生物相容性保护层1324可以包括任何适合的材料,包括例如钛及其合金、贵金属及其合金、biograde不锈钢,钴基合金、钽、铌、钛-铌合金、镍钛诺、MP35N(镍-钴-钼合金)、氧化铝、氧化锆、石英、熔融石英、生物玻璃、硅以及一些生物相容性聚合物。这些只是示例。在一些情况下,保护层1324可以提供来自身体的屏障,包括细胞、蛋白质、血小板和/或其他生物和/或化学试剂。在一些情况下,保护层1324提供密闭地密封。在一些情况下,感应线圈1312可以由耐腐蚀材料构成,例如、金、银、不锈钢等,并且不具有保护层1324。
说明性IMD 1300还可以包括靠近壳体1310的远端端部的固定机构1322,其被配置为将IMD 1300附接到心脏(例如,图12B的心脏H)的组织壁(例如,图12B的组织壁1334)或以其他方式将IMD 1300锚固到患者的解剖结构。如图12A所示,在一些情况下,固定机构1322可以包括锚固到心脏的心脏组织中的一个或多个钩或尖齿或多个钩或尖齿,以将IMD 1300附接到组织壁。在其他情况下,固定机构1322可以包括一个或多个被配置为与心脏腔室内的骨小梁缠绕的被动尖齿或多个被配置为与心脏腔室内的骨小梁缠绕的被动尖齿和/或被配置为拧入组织壁以将IMD 1300锚固到心脏的螺旋形固定锚固件。
在一些情况下,说明性IMD 1300可以包括靠近壳体1310的近端端部的对接构件1336,其被配置为便于IMD 1300的递送和/或取出。例如,对接构件1336可以沿着壳体1310的纵轴从壳体1310的近端端部延伸。对接构件1336可以包括头部1338和在壳体1310和头部1338之间延伸的颈部1340。头部1338可以是相对于颈部1340的扩大部分。例如,头部1338距IMD 1300的纵轴的径向尺寸可以大于颈部1340距IMD 1300的纵轴的径向尺寸。对接构件1336还可以包括从头部1338延伸的系绳保持结构1342。系绳保持结构1342可以限定开口1344,该开口638被配置为容纳穿过开口638的系绳或其他锚固机构。虽然保持结构1342被示出为具有大体上“U形”构造,但是保持结构1342可以采用任何形状,该形状提供围绕开口1344的封闭周边,使得系绳可以安全且可释放地通过(例如,绕过)开口1344。保持结构1342可以沿着颈部1340延伸穿过头部1338,并且到达壳体1310的近端端部或者进入壳体1310的近端端部中。对接构件1336可以被配置为便于将IMD 1300递送到心内部位和/或从心内部位取出IMD 1300。可以设想其他对接构件。
图13A-13B提供了说明性IMD1400的示意图,其可被配置为植入患者(诸如患者700(图6))体内。IMD 1400及其组件的配置和操作可以类似于关于图12A-12B描述的IMD 1300及其组件的配置和操作。在一些情况下,IMD 1400可以包括暴露在壳体1402外部的电极(即,阳极1404和阴极1406),并且可以可操作地耦合到设置在壳体1402内的控制器1418。在一些实施例中,馈通件1414、1416可以从壳体1402的外部延伸到壳体1402的内部,并且可以将阳极1404和阴极1406电连接到控制器1418。虽然示出了阳极1404和阴极1406,但是将理解,在一些情况下,IMD 1400可以包括三个、四个或更多个不同的电极。此外,在一些情况下,壳体本身1402可以被配置为操作为阳极或阴极。在一些情况下,IMD 1400可以是无引线心脏起搏器(LCP)、植入式监测设备或植入式传感器。
在各种实施例中,IMD 1400可以包括感应线圈1412。在某些实施例中,感应线圈1412可以在壳体1402的外部并且围绕壳体1402的一部分设置(例如,缠绕)。设想的是,感应线圈1412可以是各种不同类型的线圈中的任何一种。在一些情况下,外部接收器(例如,图13B的外部收发器1422)可以将患者700体内的大约10kHz和100MHz之间的功率感应地传输到IMD 1400的感应线圈1412。设想的是,***可以在无功、非辐射、近场(如感应充电***)中操作。在一些情况下,外部收发器1422可以发射近场能量,使得IMD 1400的感应线圈1412可以捕获近场能量并将其提供给控制器1418。然后,控制器1418可以利用近场能量来执行许多不同的功能和操作,诸如通过将通信信号驱动到感应线圈1412上来发送消息。在一些实施例中,一个或多个馈通件1410可以从壳体1402的外部延伸到壳体1402的内部,并且可以将感应线圈1412电连接到控制器1418。
在某些实施例中,承载感应线圈1412的壳体1402的至少一部分可由导磁材料构成或包括导磁材料。在其他情况下,可以将导磁材料固定到、嵌入承载感应线圈1412的壳体1402的部分或以其他方式由承载感应线圈1412的壳体1402的部分承载。类似于IMD 1300并且如图14所示,IMD 1400可以包括壳体1502的一部分,并且导磁材料1500可以由嵌入壳体1502的部分中的条带形成。此外,在各种实施例中,壳体1502的一部分可以由非磁性材料构成。
再次参照图13A,在一些情况下,导磁材料可以固定到、嵌入壳体1402内的一个或多个组件(诸如可再充电电源1420的电池或壳体1402内的其他组件)或以其他方式由壳体1402内的一个或多个组件承载。参照图13B,导磁材料及其位置、形状和取向可以被布置为集中、限制、引导、转向和/或聚焦通过感应线圈1412的磁场1424。在一些情况下,导磁材料相对于周围环境的导磁率(例如,大于10、100、1000、10000或更多的相对导磁率(μr))可有助于将磁通量集中在导磁材料中,其可以穿过感应线圈1412。在一些情况下,使用导磁材料可以帮助改善发射器线圈1426和感应线圈1412之间的感应耦合,并因此提高对IMD 1400的总功率传输效率。
在一些情况下,导磁材料可以是铁氧体、合金(例如,高导磁合金)、金属氧化物、金属硫化物、金属羟基氧化物或金属。这些只是示例。在一些情况下,导磁材料可以具有小于1E-4ohm-1cm-1的电导率(σ)。在一些情况下,承载感应线圈1412的壳体1402的部分可以完全由导磁材料形成,并且在一些情况下,可以具有圆柱形或基本上圆柱形的形状,或者管状或基本上管状的形状或形式。在一些情况下,壳体1402可以具有基板或基部(诸如聚合物基板或基部),其中导磁材料被附接、嵌入、设置在基板或基部上或以其他方式由基板或基部承载。
再次参照图13A,根据各种实施例,在感应线圈1412上可以存在保护层1408。保护层1408还可以在壳体1402的至少一部分上延伸。在某些实施例中,保护层1408可以是包括生物相容材料的密封剂。在各种实施例中,保护层1408可以包括屏障。在一些情况下,屏障可以提供密闭地密封。在一些情况下,保护层1408可以包括各种材料(诸如例如玻璃)。在一些情况下,感应线圈1312可以由耐腐蚀材料构成,例如、金、银、不锈钢等,并且不具有保护层1408。
可再充电电源1420可以包括任何类型的可再充电电池。在各种实施例中,可再充电电源1420可以包括导磁材料。在一些情况下,导磁材料可以具有的大于10、100、1000、或更大的相对导磁率(μr)。在某些实施例中,导磁材料可以用作电池活性材料,诸如LiFePO4、LiCoO2、LiNi0.33Mn0.33Co0.33O2(NMC)、LiNi0.8Co0.15Al0.05(NCA)和/或任何其他适合的材料。在某些实施例中,导磁材料可以分布在整个可再充电电源1420中。在一些情况下,导磁材料可以是铁氧体或金属氧化物,并且可以添加到可再充电电源1420的阴极材料中。在一些情况下,导磁材料可以是金属或金属合金,并且可以添加到可再充电电源1420的阴极或阳极材料中。
说明性IMD 1400还可以包括靠近壳体1402的远端端部的固定机构1430,其被配置为将IMD 1400附接到心脏(例如,图13B的心脏H)的组织壁(例如,图13B的组织壁1428)或以其他方式将IMD 1400锚固到患者的解剖结构。如图13A所示,在一些情况下,固定机构1430可以包括锚固到心脏的心脏组织中的一个或多个或多个钩或尖齿,以将IMD 1400附接到组织壁。在其他情况下,固定机构1430可以包括一个或多个被配置为与心脏腔室内的骨小梁缠绕的被动尖齿、或多个被配置为与心脏腔室内的骨小梁缠绕的被动尖齿和/或被配置为拧入组织壁以将IMD 1400锚固到心脏的螺旋形固定锚固件。
应当理解,本公开在许多方面仅是说明性的。在不超出本公开范围的情况下,可以进行细节上(特别是在形状、尺寸和步骤布置方面)的改变。这可以包括在适当的程度上使用在其他实施例中使用的一个示例实施例的任何特征。

Claims (15)

1.一种植入式医疗设备(IMD),其被配置为植入患者体内,所述IMD包括:
外壳,其被配置为用于经导管部署,其中所述外壳的至少一部分至少部分地由具有大于10的相对导磁率(μr)的导磁材料形成;
多个电极,其暴露在所述外壳的外部;
治疗电路,其被设置在所述外壳内并由所述外壳容纳,所述治疗电路可操作地耦合到所述多个电极并且被配置为经由所述多个电极中的一个或多个感测一个或多个信号和/或经由所述多个电极中的一个或多个刺激组织;
可再充电电源,其被设置在所述外壳内并由所述外壳容纳,并被配置为为所述治疗电路供电;
接收线圈,其设置在所述外壳的外部,使得所述接收线圈围绕至少部分地由所述导磁材料形成的所述外壳的部分延伸,其中所述外壳的所述导磁材料被配置为操作为通量集中器,以用于集中通过所述接收线圈的非辐射近场能量;以及
充电电路,其被设置在所述外壳内并由所述外壳容纳,并且与所述接收线圈和所述可再充电电源可操作地耦合,所述充电电路被配置为使用经由所述接收线圈接收到的非辐射近场能量来对所述可再充电电源进行充电。
2.根据权利要求1所述的IMD,还包括一个或多个馈通件,其从所述外壳的外部延伸到所述外壳的内部,以用于电连接所述接收线圈和所述充电电路。
3.根据权利要求1所述的IMD,还包括一个或多个馈通件,其从所述外壳的外部延伸到所述外壳的内部,以用于将所述多个电极中的一个或多个电连接到所述治疗电路。
4.根据权利要求1所述的IMD,还包括保护层,其处于所述接收线圈之上。
5.根据权利要求4所述的IMD,其中,所述保护层在所述接收线圈之上提供密闭的密封。
6.根据权利要求1所述的IMD,其中,所述导磁材料具有小于1E-4ohm-1cm-1的电导率(σ)。
7.根据权利要求1所述的IMD,其中,所述导磁材料包括铁氧体。
8.根据权利要求1所述的IMD,其中,所述导磁材料包括合金。
9.根据权利要求1所述的IMD,其中,所述外壳包括聚合物基部,其中所述导磁材料相对于所述聚合物基部固定。
10.根据权利要求1所述的IMD,其中,所述外壳的一部分本身由所述导磁材料形成。
11.根据权利要求1所述的IMD,其中,所述接收线圈被印刷在所述外壳的一部分上。
12.根据权利要求1所述的IMD,其中,被设置在所述外壳内的所述可再充电电源包括导磁材料,其具有大于10的相对导磁率(μr)。
13.一种植入式医疗设备(IMD),其被配置为植入患者体内,所述IMD包括:
外壳,其被配置为用于经导管部署,所述外壳具有至少部分地由导磁材料形成的部分,所述导磁材料具有大于10的相对导磁率(μr);
接收线圈,其设置在所述外壳的外部,使得所述接收线圈围绕至少部分地由所述导磁材料形成的所述外壳部分的至少一部分延伸,其中所述外壳部分的所述导磁材料被配置为操作为通量集中器,以用于集中通过所述接收线圈的非辐射近场能量;
操作电路,其被设置在所述外壳内并由所述外壳容纳;
可再充电电源,其被设置在所述外壳内并由所述外壳容纳,并被配置为为所述操作电路供电;以及
充电电路,其与所述接收线圈和所述可再充电电源可操作地耦合,所述充电电路被配置为使用经由接收线圈接收到的非辐射近场能量来对所述可再充电电源进行充电。
14.根据权利要求13所述的IMD,还包括一个或多个馈通件,其从所述外壳的外部延伸到所述外壳的内部,以用于连接所述接收线圈和所述充电电路。
15.根据权利要求13所述的IMD,其中,所述接收线圈由保护层密闭地密封。
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WO2018094342A1 (en) 2018-05-24
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CN109996585A (zh) 2019-07-09
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