CN111032148A - 具有压力传感器的可植入医疗设备 - Google Patents
具有压力传感器的可植入医疗设备 Download PDFInfo
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- CN111032148A CN111032148A CN201880053642.4A CN201880053642A CN111032148A CN 111032148 A CN111032148 A CN 111032148A CN 201880053642 A CN201880053642 A CN 201880053642A CN 111032148 A CN111032148 A CN 111032148A
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- 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
- A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
- A61N1/36514—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure
- A61N1/36578—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by mechanical motion of the heart wall, e.g. measured by an accelerometer or microphone
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- 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
- A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
- A61N1/368—Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions
- A61N1/3682—Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions with a variable atrioventricular delay
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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
- A61N1/362—Heart stimulators
- A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
- A61N1/368—Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions
- A61N1/3684—Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions for stimulating the heart at multiple sites of the ventricle or the atrium
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Abstract
一种配置有压力传感器的可植入医疗设备(IMD)。该IMD包括壳体和膜片，该膜片暴露在壳体外部的环境中。膜片被配置为将来自壳体外部的环境的压力传输到压电膜。作为响应，压电膜产生电压和/或电流，该电压和/或电流表示施加到壳体膜片的压力变化。在一些情况下，仅使用压力随时间的变化，而不使用绝对压力或表压。
Description
相关申请的交叉引用
本申请要求于2017年8月18日提交的美国临时专利申请序列号62/547,458的权益，其公开内容通过引用并入本文。
技术领域
本公开总体上涉及可植入医疗设备，并且更具体地涉及具有压力传感器的可植入医疗设备。
背景技术
可植入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。在一些情况下，可植入医疗设备可以向患者递送神经刺激治疗。在一些情况下，可植入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，诸如另一个可植入医疗设备或外部编程器。
在一些情况下，可植入医疗设备可以被配置为向患者递送起搏和/或除颤治疗。这样的可植入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，可以将各种设备(例如，起搏器、除颤器等)植入到患者的身体中。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。在一些情况下，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。
发明内容
本公开总体上涉及可植入医疗设备，并且更具体地涉及具有压力传感器的可植入医疗设备。
在第一示例中，无引线心脏起搏器(LCP)可以被配置为感测心脏活动并且向患者的心脏递送起搏治疗。所述LCP可以包括：壳体，其具有近端端部和远端端部；第一电极，其相对于所述壳体固定并且暴露于所述壳体外部的环境；第二电极，其相对于所述壳体固定并且暴露于所述壳体外部的环境；膜片(diaphragm)，其暴露于所述壳体外部的环境，所述膜片响应于由所述壳体外部的环境施加到所述膜片的外部压力；压电膜(membrane)，其具有第一压力传感器电极和第二压力传感器电极，所述压电膜可以被配置为响应于施加到所述膜片的压力变化而在所述第一压力传感器电极和所述第二压力传感器电极之间产生电压，所述电压表示施加到所述膜片的外部压力变化；以及所述壳体中的电路，其被可操作地耦合到所述LCP的所述第一电极和所述第二电极，并且还可操作地耦合到所述第一压力传感器电极和所述第二压力传感器电极，所述电路可以被配置为经由所述LCP的所述第一电极和所述第二电极向患者的心脏递送起搏治疗，其中所述起搏治疗至少部分取决于由所述压电膜产生并且表示施加到所述膜片的外部压力变化的电压。
作为上述示例中的任何示例的替代或补充，在另一示例中，所述电路可以被配置为通过监视由所述压电膜在所述第一压力传感器电极和所述第二压力传感器电极之间产生的电压来检测压力脉冲。
作为上述示例中的任何示例的替代或补充，在另一示例中，所述膜片可以具有面向所述壳体内部的内表面，并且所述压电膜可以被固定到所述膜片的所述内表面的至少一部分。
作为上述示例中的任何示例的替代或补充，在另一示例中，所述膜片可以具有面向所述壳体内部的内表面，并且所述压电膜可以与所述膜片的所述内表面间隔开一定距离，并可以经由不可压缩的流体可操作地耦合到所述膜片的所述内表面。
作为上述示例中的任何示例的替代或补充，在另一示例中，所述不可压缩的流体可以在至少部分地由所述膜片的所述内表面限定的流体腔中，并且可以与所述膜片的所述内表面和所述压电膜两者都流体连通，其中，所述流体腔可以被配置为将由所述膜片施加到不可压缩的流体的压力传送到所述压电膜。
作为上述示例中的任何示例的替代或补充，在另一示例中，所述膜片可以具有面向所述壳体内部的内表面，并且所述压电膜可以与所述膜片的所述内表面间隔开一定距离，并可以经由机械联动装置可操作地耦合到所述膜片的所述内表面，其中所述机械联动装置可以被配置为将所述膜片的运动转换成施加到所述压电膜的压力。
作为上述示例中的任何示例的替代或补充，在另一示例中，所述壳体的所述膜片可以包括一个或多个轮廓(contour)。
作为上述示例中的任何示例的替代或补充，在另一示例中，所述电路可以被配置为检测由心脏的第二腔室的收缩引起的心脏的第一腔室中的压力变化。
作为上述示例中的任何示例的替代或补充，在另一示例中，所述第一腔室可以是心室，并且所述第二腔室可以对应的心房。
作为上述示例中的任何示例的替代或补充，在另一示例中，所述膜片可以与所述壳体一体形成。
作为上述示例中的任何示例的替代或补充，在另一示例中，所述膜片可以气密密封在所述壳体上。
作为上述示例中的任何示例的替代或补充，在另一示例中，所述LCP还可以包括：处于所述壳体的所述远端端部处的固定构件，其用于将所述壳体的所述远端端部固定到植入部位，并且其中所述壳体的所述膜片邻近所述壳体的所述近端端部。
作为上述示例中的任何示例的替代或补充，在另一示例中，所述壳体可以包括细长主体，其具有面向远端的远端端部表面和面向近端的近端端部表面，其中所述壳体的所述膜片可以位于所述壳体的所述近端端部表面上。
作为上述示例中的任何示例的替代或补充，在另一示例中，所述膜片和/或所述压电膜可以被形成为使在植入时所述膜片和/或所述压电膜的动态变化最大化。
作为上述示例中的任何示例的替代或补充，在另一示例中，所述LCP还可以包括：被布置在所述壳体的所述膜片上方的抗血栓形成涂层。
在另一示例中，一种无引线心脏起搏器(LCP)，其可以被配置为感测心脏活动并向患者心脏递送起搏治疗。所述LCP可以包括：壳体，其具有近端端部和远端端部；第一电极，其相对于所述壳体固定并且暴露于所述壳体外部的环境；第二电极，其相对于所述壳体固定并且暴露于所述壳体外部的环境；膜片，其暴露于所述壳体外部的环境，所述膜片响应于由所述壳体外部的环境施加到所述膜片的外部压力；压电膜，其具有第一压力传感器电极和第二压力传感器电极，所述压电膜可以被配置为响应于施加到所述膜片的压力变化而在所述第一压力传感器电极和所述第二压力传感器电极之间产生电压，所述电压表示施加到所述膜片的外部压力变化；以及所述壳体中的电路，其被可操作地耦合到所述LCP的所述第一电极和所述第二电极，并且还可操作地耦合到所述第一压力传感器电极和所述第二压力传感器电极，所述电路可以被配置为经由所述LCP的所述第一电极和所述第二电极向患者的心脏递送起搏治疗，其中所述起搏治疗至少部分取决于由所述压电膜产生并且表示施加到所述膜片的外部压力变化的电压。
作为上述示例中的任何示例的替代或补充，在另一示例中，所述电路可以被配置为通过监视由所述压电膜在所述第一压力传感器电极和所述第二压力传感器电极之间产生的电压来检测压力脉冲。
作为上述示例中的任何示例的替代或补充，在另一示例中，所述膜片可以具有面向所述壳体内部的内表面，并且所述压电膜可以被固定到所述膜片的所述内表面的至少一部分。
作为上述示例中的任何示例的替代或补充，在另一示例中，所述膜片可以具有面向所述壳体内部的内表面，并且所述压电膜可以与所述膜片的所述内表面间隔开一定距离，并可以经由不可压缩的流体可操作地耦合到所述膜片的所述内表面。
作为上述示例中的任何示例的替代或补充，在另一示例中，所述不可压缩的流体可以在至少部分地由所述膜片的所述内表面限定的流体腔中，并且可以与所述膜片的所述内表面和所述压电膜两者都流体连通，其中，所述流体腔可以被配置为将由所述膜片施加到不可压缩的流体的压力传送到所述压电膜。
作为上述示例中的任何示例的替代或补充，在另一示例中，所述膜片可以具有面向所述壳体内部的内表面，并且所述压电膜可以与所述膜片的所述内表面间隔开一定距离，并可以经由机械联动装置可操作地耦合到所述膜片的所述内表面，其中所述机械联动装置可以被配置为将所述膜片的运动转换成施加到所述压电膜的压力。
作为上述示例中的任何示例的替代或补充，在另一示例中，所述壳体的所述膜片可以包括一个或多个轮廓。
作为上述示例中的任何示例的替代或补充，在另一示例中，所述电路可以被配置为检测由心脏的第二腔室的收缩引起的心脏的第一腔室中的压力变化。
作为上述示例中的任何示例的替代或补充，在另一示例中，所述第一腔室可以是心室，并且所述第二腔室可以对应的心房。
作为上述示例中的任何示例的替代或补充，在另一示例中，所述膜片可以与所述壳体一体形成。
作为上述示例中的任何示例的替代或补充，在另一示例中，所述膜片可以气密密封在所述壳体上。
作为上述示例中的任何示例的替代或补充，在另一示例中，所述LCP还可以包括：处于所述壳体的所述远端端部处的固定构件，其用于将所述壳体的所述远端端部固定到植入部位，并且其中所述壳体的所述膜片可以邻近所述壳体的所述近端端部。
作为上述示例中的任何示例的替代或补充，在另一示例中，所述壳体可以包括细长主体，其具有面向远端的远端端部表面和面向近端的近端端部表面，其中所述壳体的所述膜片可以位于所述壳体的所述近端端部表面上。
作为上述示例中的任何示例的替代或补充，在另一示例中，所述膜片和/或所述压电膜可以被形成为使在植入时所述膜片和/或所述压电膜的动态变化最大化。
在另一示例中，无引线心脏起搏器(LCP)可以被配置为感测心脏活动并且使患者的心脏起搏。所述LCP可以包括：壳体，其具有近端端部和远端端部；第一电极，其相对于所述壳体固定并且暴露于所述壳体外部的环境；第二电极，其相对于所述壳体固定并且暴露于所述壳体外部的环境，所述壳体具有暴露于所述壳体外部的环境的膜片，所述膜片响应于由所述壳体外部的环境施加到所述膜片的压力，压电材料，其可操作地耦合到所述壳体的所述膜片，以用于通过产生表示所述壳体外部的环境施加到所述膜片的压力的电荷来检测所述膜片的偏转(deflection)；以及所述壳体中的电路，其与所述第一电极、所述第二电极和所述压电材料可操作地通信，所述电路可以被配置为经由所述第一电极和所述第二电极将起搏治疗递送到患者的心脏，其中所述起搏治疗至少部分取决于由所述压电材料产生并且表示由所述壳体外部的环境施加到所述膜片的压力的电荷。
作为上述示例中的任何示例的替代或补充，在另一示例中，所述电路可以被配置为通过监视由所述压电材料产生的电荷来检测压力脉冲。
作为上述示例中的任何示例的替代或补充，在另一示例中，所述电路可以被配置为检测由心脏的第二腔室的收缩引起的心脏的第一腔室中的压力变化。
作为上述示例中的任何示例的替代或补充，在另一示例中，所述第一腔室可以是心室，并且所述第二腔室可以对应的心房。
在另一个示例中，可植入医疗设备(IMD)可以包括：壳体，其具有近端端部和远端端部；第一电极，其相对于所述壳体固定并且暴露于所述壳体外部的环境；第二电极，其相对于所述壳体固定并且暴露于所述壳体外部的环境，所述壳体具有暴露于所述壳体外部的环境的膜片，所述膜片响应于由所述壳体外部的环境施加到所述膜片的压力，压电膜，其布置在所述膜片的内表面上，所述压电膜响应于由所述壳体外部的环境对所述膜片施加的压力而产生电荷，所述壳体中的电路，其与所述第一电极、所述第二电极和所述压电膜可操作地通信，所述电路可以被配置为经由所述第一电极和所述第二电极将电刺激治疗递送到患者的心脏，其中所述治疗至少部分取决于由所述压电膜产生并且表示由所述壳体外部的环境施加到所述膜片的压力的电荷。
作为上述示例中的任何示例的替代或补充，在另一示例中，所述压电膜可包括聚偏二氟乙烯(PVDF)。
作为上述示例中的任何示例的替代或补充，在另一示例中，所述电路可以被配置为检测由心脏的第二腔室的收缩引起的心脏的第一腔室中的压力变化。
上述发明内容并不意图描述本公开的每个实施例或每个实施方式。通过参考结合附图的以下描述和权利要求，本公开的优点和成就以及对本公开的更全面理解将变得显而易见并被领会到。
附图说明
结合附图而考虑各种说明性实施例的以下描述可以更全面地理解本公开，其中：
图1是根据本公开的一个示例的说明性无引线心脏起搏器(LCP)的示意性框图；
图2是另一医疗设备(MD)的示意性框图，该另一医疗设备(MD)可以与LCP 100(图1)结合使用，以便检测和/或治疗心律失常和其他心脏病；
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系统的示意图；
图4是根据本公开的又另一示例的包括LCP和另一医疗设备的示例性医疗系统的示意图；
图5是根据本公开的又另一示例的包括LCP和另一医疗设备的示例性医疗系统的示意图；
图6是说明性LCP的侧视图；
图7A是在心室充盈期间植入心脏内的示例LCP的平面图；
图7B是在心室收缩期间植入心脏内的示例LCP的平面图；
图8是示出了随时间推移心脏内的示例压力和容积(volume)的曲线图；
图9是说明性LCP的示意性截面视图；
图10是用于与诸如LCP的可植入医疗设备(IMD)一起使用的说明性压力传感器的示意性截面视图；
图11是用于与诸如LCP的IMD一起使用的说明性压力传感器的示意性截面视图；
图12是另一说明性LCP的近端端部部分的示意性截面视图；
图13是另一说明性LCP的近端端部部分的示意性截面视图；
图14是另一说明性LCP的近端端部部分的示意性截面视图；并且
图15是另一说明性LCP的近端端部的示意性截面视图。
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，应当理解的是，不旨在将本公开的各方面限制于所描述的特定说明性实施例。相反，旨在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
应当参考其中将不同附图中的类似元件相同地编号的附图来阅读以下描述。本描述和不一定按比例的附图描绘说明性实施例而不旨在限制本公开的范围。虽然本公开适用于任何合适的可植入医疗设备(IMD)，但是下面的描述使用起搏器、并且更特别地无引线心脏起搏器(LCP)作为特定示例。
正常、健康的心脏通过在整个心脏中传导固有生成的电信号而引发收缩。这些固有信号使心肌细胞或心脏组织收缩。该收缩迫使血液进出心脏，从而提供血液在整个身体的其余部分中的循环。然而，许多患者患有影响其心脏的这种收缩的心脏病。例如，一些心脏可能形成不再生成或传导固有电信号的病变组织。在一些示例中，病变的心脏组织以不同的频率传导电信号，从而导致心脏的不同步的且低效率的收缩。在其他示例中，心脏可能以如此低的频率发起固有信号，使得心率变得危险地低。在又其他示例中，心脏可能以异常高的频率生成电信号。在一些情况下，这种异常可以发展成纤颤状态，其中患者心室的收缩几乎完全不同步，并且心脏泵送很少血液甚至不泵送血液。可植入医疗设备(其可以被配置为确定这种心脏异常或心律失常的发生并向患者的心脏递送一个或多个类型的电刺激治疗)可以帮助终止或减轻这些以及其他心脏病。
图1描绘了说明性无引线心脏起搏器(LCP)，其可以被植入到患者中并且可以通过例如适当地采用一个或多个治疗(例如抗心动过速起搏(ATP)治疗、心脏再同步治疗(CRT)、心动过缓治疗、除颤脉冲等)来预防、控制或终止患者的心律失常。如在图1中可以看到的，LCP 100可以是紧凑型设备，其中所有部件容纳在LCP 100内或直接在壳体120上。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、其他医疗设备等通信。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，远程设备(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、消息等的信息通过通信模块102传送到外部医疗设备。外部医疗设备可以使用所传送的信号、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、分析所接收的数据)和/或执行任何其他合适的功能。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、分析所接收的数据、和/或执行任何其他合适的功能。通信模块102可以被配置为使用一个或多个方法来与远程设备通信。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可以包括一个或多个附加电极114'。在这样的示例中，脉冲发生器104还可以被电连接到附加电极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可以通过使用LCP 100内的电池112中所存储的能量来生成电刺激信号，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，以将电极114和/或电极114'中的一个或多个选择性地连接到脉冲发生器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可以生成具有特定特征或特定序列的电刺激信号，以便提供许多不同刺激治疗中的一个或多个治疗。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、心脏不同步、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/或产生任何其他合适的电刺激治疗。一些更常见的电刺激治疗包括心动过缓治疗、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。
在一些示例中，LCP 100可以不包括脉冲发生器104或者可以关闭脉冲发生器104。当如此提供时，LCP 100可以是仅诊断型设备。在这样的示例中，LCP 100可以不向患者递送电刺激治疗。相反，LCP 100可以收集关于患者的心电活动和/或生理参数的数据，并且经由通信模块102将这样的数据和/或确定传送到一个或多个其他医疗设备。
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，LCP100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，则由LCP 100通过电极114/114'感测到的心电信号可以表示心室性心电信号。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、血液压力传感器、心音传感器、血氧传感器、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和/或化学参数的任何其他合适的传感器。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LCP100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。
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。基于所接收的信号，处理模块110可以确定例如心律失常的发生，并且在一些情况下，确定心律失常的类型。基于任何所确定的心律失常，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电刺激以治疗所确定的一个或多个心律失常。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心律失常、确定心律失常的类型、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时具有更大的灵活性。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。在一些示例中，电池112可以是不可再充电的锂基电池。在其他示例中，根据需要，不可再充电的电池可以由其他合适的材料制成。因为LCP 100是可植入设备，所以在植入后对LCP100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可以是可充电的电池，这可以帮助增加LCP 100的可使用寿命。在又其他示例中，根据需要，电池112可以是一些其他类型的电源。
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定机构中的任何一个。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、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/或治疗心脏心律失常和其他心脏病。在所示的示例中，MD200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。在一些示例中，MD 200可以比LCP 100在壳体220内具有更大的容积。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。
虽然预期的是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被植入在患者心脏上、内或附近。引线212可以包含一个或多个电极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。引线212中的一些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，一个或多个电极214可以皮下被定位但邻近患者的心脏。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将该信号递送到患者的心脏(直接地或间接地)。
与机械感测模块108一样，机械感测模块208可以包含或者电连接到一个或多个传感器，诸如加速度计、血压传感器、心音传感器、血氧传感器、声学传感器和/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，但这不是要求的。在一些示例中，传感器中的一个或多个可以位于壳体220中。
虽然不是要求的，但在一些示例中，MD 200可以是可植入医疗设备。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的各种部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可以是可植入心脏起搏器(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或通过命令LCP起搏而与LCP协作来递送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可以是可植入心脏复律除颤器(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。在一些情况下，MD 200可以是皮下可植入心脏复律除颤器(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，但这不是要求的。在一些情况下，S-ICD引线可以从S-ICD罐(S-ICD can)皮下地延伸到胸骨周围，并且可以在胸骨的内表面附近终止。
在一些示例中，MD 200可以不是可植入医疗设备。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。MD 200还可以被配置为通过命令LCP递送治疗来经由LCP递送电刺激。
图3示出了具有通信路径的示例医疗设备系统，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，医疗设备系统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。在一些实施例中，外部设备306可以与显示器312一起提供或与显示器312通信。显示器312可以是个人计算机、平板计算机、智能电话、膝上型计算机或其他期望的显示器。在一些情况下，显示器312可以包括用于接收来自用户的输入的输入装置。例如，显示器312也可以包括键盘、鼠标、可致动的(例如可推动的)按钮或触摸屏显示器。这些只是示例。其他传感器/设备310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，诸如加速度计或血压传感器等。在一些情况下，其他传感器/设备310可以包括可被用于对系统300的一个或多个设备进行编程的外部编程器设备。
系统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系统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系统300的一个或多个其他设备306和310。在一些情况下，系统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合适的电刺激)。在另一示例中，LCP 302和/或304可以感测血压的指示(例如经由一个或多个压力传感器)和容积的指示(例如经由在LCP的电极之间或在LCP之间的阻抗、经由放置在LCP内的超声波换能器、或者经由放置在心脏上的与LCP通信的应变传感器)。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，并且基于所接收的信号，确定压力-容积环，并且在一些情况下，可以将这样的信息经由通信路径308传送到系统300的一个或多个其他设备302/304、306和310。
可以预期的是，通信路径308可以使用RF信号、感应式耦合、传导式耦合光学信号、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，设备通信路径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、感应式通信)与LCP302/304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将信号发送到其他传感器/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，系统300的设备可以具有允许这种传导式通信的部件。例如，系统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”到系统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，系统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阈值。尽管在一些情况下，所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)。
可以以任何合适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合适的电脉冲。
在一些情况下，通信路径308可以包括感应式通信，并且当如此提供时，系统300的设备可以被配置为传送/接收感应式通信信号。
图4和图5示出了可以被配置为根据本文公开的技术操作的说明性医疗设备系统。在图4中，LCP 402被示出为固定到心脏410的右心室的内部，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、408b、408c的引线412。在一些情况下，脉冲发生器406可以是皮下可植入心脏复律除颤器(S-ICD)的一部分，并且一个或多个电极408a、408b、408c可以被皮下地定位在心脏附近。在一些情况下，S-ICD引线可以从S-ICD罐皮下地延伸到胸骨周围，并且一个或多个电极408a、408b、408c可以被定位在胸骨的内表面附近。在一些情况下，LCP 402可以与皮下可植入心脏复律除颤器(S-ICD)通信。
在一些情况下，根据需要，LCP 402可以在心脏的左心室、右心房或左心房中。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。
在图5中，LCP 502被示出为固定到心脏510的左心室的内部，并且脉冲发生器506被示出为耦合到具有一个或多个电极504a、504b、504c的引线512。在一些情况下，脉冲发生器506可以是可植入心脏起搏器(ICP)和/或可植入心脏复律除颤器(ICD)的一部分，并且一个或多个电极504a、504b、504c可以被定位在心脏510中。在一些情况下，LCP 502可以与可植入心脏起搏器(ICP)和/或可植入心脏复律除颤器(ICD)通信。
医疗设备系统400和500也可以包括外部支持设备，诸如外部支持设备420和520。外部支持设备420和520可以被用于使用本文描述的通信技术中的一个或多个来执行诸如设备识别、设备编程和/或所存储的数据在设备之间的实时的传递的功能。作为一个示例，外部支持设备420和脉冲发生器406之间的通信经由无线模式来执行，并且脉冲发生器406和LCP 402之间的通信经由传导模式来执行。在一些示例中，LCP 402和外部支持设备420之间的通信是通过脉冲发生器406发送通信信息来完成的。然而，在其他示例中，LCP 402和外部支持设备420之间的通信可以是经由通信模块。在一些实施例中，外部支持设备420、520可以被提供有显示器422、522或者与显示器422、522通信。显示器422、522可以是个人计算机、平板计算机、智能电话、膝上型计算机或其他期望的显示器。在一些情况下，显示器422、522可以包括用于接收来自用户的输入的输入装置。例如，显示器422、522也可以包括键盘、鼠标、可致动的按钮或触摸屏显示器。这些只是示例。
图4-5示出了可以被配置为根据本文公开的技术操作的医疗设备系统的两个示例。其他示例医疗设备系统可以包括另外的或不同的医疗设备和/或配置。例如，适合于根据本文公开的技术操作的其他医疗设备系统可以包括植入在心脏内的另外的LCP。另一示例医疗设备系统可以包括多个LCP，而没有诸如脉冲发生器406或506的其他设备，其中至少一个LCP能够递送除颤治疗。在又其他示例中，医疗设备、引线和/或电极的配置或放置可以与图4和图5中描绘的那些配置或放置不同。因此，应该认识到的是，不同于图4和图5中描绘的医疗设备系统的许多其他医疗设备系统可以根据本文公开的技术操作。如此，图4和图5中所示的示例不应被视为以任何方式进行限制。
图6是说明性可植入无引线心脏起搏器(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可以包括本文描述的模块和/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可以暴露于壳体612外部的环境(例如，暴露于血液和/或组织)。
可以预期的是，壳体612可以采用各种不同的形状。例如，在一些情况下，壳体612可以具有大体上圆柱形的形状。在其他情况下，壳体612可以具有半圆顶形状。在又其他实施例中，壳体612可以是矩形棱柱。可以预期的是，壳体可以采用期望的任何截面形状，包括但不限于环形、多边形、椭圆形、方形等。
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也可以包括：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之间的电通信可以向心脏组织提供电刺激和/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。如图6所示，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或多个被动尖齿和/或被配置为拧入组织壁中以将LCP 610锚定到心脏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可以具有距LCP610的纵轴的径向尺寸，该径向尺寸大于颈部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(未明确示出)。系绳保持结构可以限定开口，开口被配置为容纳穿过开口的系绳或其他锚固机构。保持结构可以采取任何形状，其提供围绕开口的封闭周边，使得系绳可以牢固且可释放地穿过(例如，绕过)开口。在一些情况下，保持结构可以沿着颈部634延伸穿过头部632，并且到壳体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，但是可以预期的是，对接构件630在被提供时可以具有任何合适的构造。
可以预期的是，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暴露于壳体612外部的环境和/或以另外方式与壳体612外部的环境可操作地耦合以测量心脏内的血压。在一些情况下，一个或多个压力传感器640可以耦合到壳体612的外表面。在其他情况下，一个或多个压力传感器640可以被定位在壳体612内，其中压力作用在壳体上和/或壳体612上的端口上以影响压力传感器640。例如，如果LCP610被放置在右心室中，则一个或多个压力传感器640可以测量右心室内的压力。如果LCP 610被放置在心脏的另一部分(诸如心房中的一个或左心室)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。可以预期的是，当LCP放置在右心室中时，一个或多个压力传感器640可以足够灵敏以检测右心房中的压力变化(例如心房强力收缩)。本文将更详细地描述一些说明性压力传感器配置。
在一些情况下，一个或多个压力传感器640可以包括可变形的膜片，该膜片的一部分或全部由压电材料形成，该压电材料不需要外部电源即可起作用。在一些情况下，一个或多个压力传感器640可以包括MEMS设备，诸如具有压力膜片的MEMS设备(在该膜片上具有一个或多个压电传感器和/或压电电阻器)、电容器-微机械加工的超声波换能器(cMUT))、电容器、微压力计、表面声波(SAW)设备和/或任何其他适于测量施加到膜片的压力的合适的传感器。在2016年10月27日提交的题为“IMPLANTABLE MEDICAL DEVICE WITH PRESSURESENSOR”的共同受让的专利申请号62/413,766中描述了一些说明性但非限制性的压力传感器和配置，该申请通过引用并入本文。可以预期的是，当使用压电电阻器时，压阻桥可以在低功率模式(例如，有限的占空比激励)下操作以减少传感器的功率需求。在一些情况下，可以对增益进行调制以进一步降低功率需求。
当使用压电材料时，压电材料可以响应于施加到压电材料上的压力变化而在第一压力传感器电极和第二压力传感器电极之间产生电压(和/或电流)。电压(和/或电流)可以表示压力变化。在这种情况下，压电材料可能不需要任何外部电源，而是压电材料本身可以将从压力变化中提取的能量转换成电压(和/或电流)，然后LCP可以将其用于识别压力变化。在一些情况下，可能没有必要甚至不期望测量绝对压力值。相反，仅检测压力变化是识别某些压力事件所必需的。
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。可以预期的是，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。一个或多个压力传感器640可以测量/感测植入了LCP 610的腔室中的压力。例如，植入在右心室(RV)中的LCP 610可以感测RV压力。还可以预期的是，一个或多个压力传感器640可以足够灵敏以检测其他腔室以及LCP 610所定位于的腔室中的压力变化。例如，当LCP610被定位在右心室内时，除了右心室中的压力变化之外，一个或多个压力传感器640还可以检测右心房中的压力变化(例如心房强力收缩)。
在一些情况下，感测心房压力事件可以允许设备610检测心房收缩，从而导致例如心房强力收缩。右心室中的LCP可以使用这种心房压力事件的变化来定时心室的起搏脉冲，以支持治疗心动过缓事件。在一些情况下，可以调整心室起搏脉冲的定时，以使通过被动充盈进入右心室的血液量最大化。在一些情况下，这可以包括调整相对于心房基准(例如，心房强力收缩)的AV延迟。在一些情况下，测量出的压力随时间的变化可用于支持CRT心脏治疗(如果放置在左心室中)、患者健康状况监视和/或任何其他合适目标的管理。可以预期使用单个LCP测量心室和心房两者中的压力事件可以复制具有单个设备的双腔室系统。例如，这样的系统可以使得设备能够被定位在心室中，同时听到心室和心房两者并相应地起搏(例如，VDD设备)。
一个或多个压力传感器640可以(单独地或与LCP 610中的其他电路组合地)被配置为导出压力随时间的变化，并且可以被用于调节心房至心室(AV)的起搏延迟，以优化用于治疗心动过缓事件的起搏。在一些情况下，一个或多个压力传感器640可以被配置为检测α波(例如心房强力收缩)并且改变LCP 610针对关于右心房的收缩的心室起搏的起搏定时。还可以预期的是，感测压力可以在植入过程期间被用于通过在不同植入位置进行取样并使用最佳位置来优化LCP 610在腔室(例如，RV)中的放置。在一些情况下，频繁的压力监视可以有益于对心力衰竭患者的管理。频繁的压力监视对于患有慢性心脏病、高血压、反流、瓣膜问题、心房收缩检测也是有用的，并且有助于解决其他问题。还可以预期的是，一个或多个压力传感器640可被用于监视呼吸和相关联的疾病(例如，慢性阻塞性肺病(COPD)等)。这些只是示例。
在一些情况下，压力读数可以与心脏腔室容积测量结果诸如阻抗测量结果(例如，在电极620和电极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。阻抗可以是腔室容积的替代，并因此压力-阻抗环可以表示心脏H的压力-容积环。
图7A是在心室充盈期间植入在心脏H的右心室RV内的示例无引线心脏起搏设备610的平面图。还示出了右心房RA、左心室LV、左心房LA和主动脉A。图7B是在心室收缩期间植入在心脏H的右心室内的无引线心脏起搏设备610的平面图。这些图说明了右心室的容积在心动周期内可以如何变化。如在图7A和7B中可以看到的，心室充盈期间右心室的容积大于心室收缩期间心脏的右心室的容积。
在一些情况下，处理模块和/或其他控制电路可以在一个或多个心动周期中的每个内的时间点捕获心脏(例如，右心室和/或右心房)内的一个或多个压力，从而产生一个或多个压力数据点。这些一个或多个数据点可以与在一个或多个心动周期期间的不同时间取得的其他压力数据点组合使用，以生成压力曲线。在一些情况下，可以从压力曲线提取或导出一个或多个参数。压力曲线可以被用于促进心脏再同步治疗(CRT)、患者健康状态监视和/或非CRT心脏治疗的管理。
图8是示出了随时间推移心脏内的示例压力和容积的曲线图800。更具体地，图8描绘了心脏H的主动脉压力、左心室压力、左心房压力、左心室容积、心电图(ECG或egram)和心音。心动周期可以以舒张期开始，并且二尖瓣打开。心室压力降到低于心房压力，从而导致心室充血。在心室充盈期间，主动脉压力如所示缓慢下降。在收缩期期间，心室收缩。当心室压力超过心房压力时，二尖瓣关闭，从而生成S1心音。在主动脉瓣打开之前，发生等容收缩阶段，其中心室压力迅速增加但心室容积没有显著变化。一旦心室压力等于主动脉压力，主动脉瓣就打开，并且血液从左心室被射入到主动脉中的射血阶段开始。射血阶段持续到心室压力降到低于主动脉压力为止，此时主动脉瓣关闭，从而生成S2心音。此时，等容舒张阶段开始，并且心室压力迅速下降直至心房压力超过心室压力为止，此时二尖瓣打开，并且循环重复。心房的收缩始于心室舒张结束附近。除了与被动充盈相关的容积外，主动心房收缩还推动或迫使额外容积的血液进入心室(通常称为“心房强力收缩”)。在一些情况下，心房强力收缩对朝向心室预负荷的血液容积的贡献在约20％的范围内。在正常心率下，心房收缩被认为是充分的心室充盈所必需的。然而，随着心律的增加，心房充盈对于心室充盈变得越来越重要，这是因为被动充盈的收缩之间的时间间隔逐渐变得更短。可以同样地生成肺动脉、右心房和右心室的心脏压力曲线以及右心室的心脏容积曲线，其类似于图8中针对心脏的左侧部分示出的那些曲线。通常，右心室中的心脏压力低于左心室中的心脏压力。
在一个示例中，可以使用声学传感器(例如，麦克风)来记录心音信号，所述声学传感器捕获由心音产生的声波。在另一示例中，可以使用加速度计或压力传感器来记录心音信号，所述加速度计或压力传感器捕获由心音引起的加速度或压力波。可以在心脏内部或外部来记录心音信号。这些只是示例。
图9是说明性可植入无引线心脏起搏器(LCP)900的截面。LCP 900在形式和功能上可以与上述的LCP 100、610类似。LCP 900可以包括以上关于LCP100、610描述的模块和/或结构特征中的任一个。LCP 900可以包括具有近端端部904和远端端部906的外壳或壳体902。在所示的示例中，LCP 900不包括对接构件。然而，在一些情况下，可以提供对接构件，诸如从壳体902的侧壁附近向近端延伸的笼、头或其他特征。说明性LCP 900包括：相对于壳体902固定并且邻近壳体902的远端端部906定位的第一电极908、以及相对于壳体902固定并且邻近壳体902的近端端部904定位的第二电极(未明确示出)。在一些情况下，第一电极908可以被定位在面向远端的远端端部表面上。在一些情况下，壳体902可以包括导电材料，并且沿其长度的一部分可以是绝缘的。沿近端端部904的截面可以没有绝缘，以便限定第二电极。电极908可以是感测和/或起搏电极，以帮助提供电治疗和/或感测能力。第一电极908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，而第二电极可以与第一电极908间隔开。第一电极908和/或第二电极可以暴露于壳体902外部的环境(例如，暴露于血液和/或组织)。
在一些情况下，LCP 900在壳体902内可以包括脉冲发生器(例如，电路)910和电源(例如，电池)912，以经由第一电极和第二电极提供和/或接收电信号。虽然图9中没有明确示出，但是LCP 900也可以包括：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902内。脉冲发生器和电极之间的电连通可以向心脏组织提供电刺激和/或感测生理状况。
在所示的示例中，LCP 900还包括靠近壳体902的远端端部906的固定机构914。固定机构914被配置为将LCP 900附接到心脏H的壁，或者以其他方式将LCP 900锚固到患者的解剖结构。如图9中所示，在一些情况下，固定机构914可以包括锚固到心脏H的心脏组织中的一个或多个、或多个钩或尖齿916，以将LCP 900附接到组织壁。在其他情况下，固定机构914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、或多个被动尖齿和/或被配置为拧入到组织壁中以将LCP 900锚固到心脏H的螺旋固定锚固件。这些只是示例。
壳体902可以包括面向近端的近端端部表面918(例如，在与远端端部表面大体相反的方向上)。在一些情况下，壳体902的近端端部表面918可以形成膜片920。在一些情况下，膜片920可以由壳体材料本身形成。当如此提供时，在膜片920的区域中的壳体的壁厚可以被减薄，以增加膜片920的柔性，以便响应于感兴趣的压力范围(例如，充分可变形)。在其他情况下，膜片920可以由另一种材料(诸如但不限于钛、钛箔、硅树脂、聚酰亚胺等)形成，以形成可变形或可移动的膜片920，膜片920响应于施加到膜片920的感兴趣的压力。在一些情况下，膜片920可以是在聚偏二氟乙烯(PVDF)上的钛或钛箔。在一些情况下，膜片920可以由压电材料形成和/或可以包括压电层。
压电材料可能会表现出压电效应，或者当材料受到机械应力或振动时会产生电压(和/或电流)。一些说明性的压电材料可以包括但不限于某些天然存在的晶体(例如石英、蔗糖、罗谢尔盐、黄玉、钛酸铅等)、合成晶体、陶瓷(例如钛酸钡、锆钛酸铅(PZT)、氧化锌等)、聚合物(例如聚偏二氟乙烯(PVDF))等。此列表并不旨在穷尽所有类型的压电材料，而只是说明一些示例材料。当用作围绕LCP的气密密封的一部分时，可以预期的是，针对膜片920选择的(压电或其他)材料可以是气密的。例如，该材料应能够防止血液通过膜片扩散并进入内部或LCP中。
在任何情况下，膜片920可以被制造成随着心脏(例如，右心室和/或右心房)中的压力(壳体902的外部)的变化而弯曲或变形，如将在本文中更详细描述的。虽然整个近端端部表面918可以形成膜片920，但可以预期的是，仅近端端部表面918的一部分可以形成膜片920。在一些情况下，膜片920的直径可以是1毫米或更小。在其他情况下，膜片920的直径可以大于1毫米。在一些情况下，膜片920可以具有圆形形状。在其他情况下，膜片920可以具有正方形、矩形或任何其他合适的形状。在一些情况下，膜片920可能不具有均匀的厚度。在一些情况下，膜片920可具有较厚的凸出区域，其提供支撑以例如增加膜片920随压力变形的线性度。
在一些情况下，膜片920可以由压电材料形成。当膜片响应于外部压力而弯曲或变形时，压电材料可以在压电材料的相对侧上的传感器电极之间产生电压(和/或电流)。所产生的电压(和/或电流)可以经由一个或多个电导体924被传递到电路910，其可以识别压力事件和/或压力值。在一些情况下，所产生的电压(和/或电流)可能反映压力随时间的变化，而不是绝对压力或表压。当如此提供时，可能不需要参考压力。在任何情况下，压力随时间的变化可足以识别诸如心房收缩(例如，心房强力收缩)、心室充盈、心室射血等事件。在一些情况下，电路910可以被配置为以大于100赫兹(Hz)的采样率获得压力测量结果，但这不是要求的。这可以允许压力测量结果被用于确定心动周期的特性，包括但不限于dP/dT、重搏切迹等。
在一些情况下，一个或多个电导体924可以包括耦合到压电材料的第一侧上的第一电极的第一电导体，以及耦合到压电材料的第二相对侧上的第二电极的第二电导体，从而将产生的电压(和/或电流)传输到电路910。
膜片920不需要放置在壳体902的近端端部表面918上，如图9所示。可以预期的是，膜片920可以形成在暴露于壳体902外部的环境的任何表面中。在一些情况下，将膜片920定位在壳体902的近端端部904上或附近可以使膜片朝向心脏瓣膜定向(当LCP 900被定位在心脏的顶点时)并且与心脏内的预期最大压力变化成直线，这可以实现较高的信噪比(SN)水平。也可以将膜片920定位成远离心脏壁，这可以降低膜片920将变成纤颤传递(fibrossed-over)的可能性。在一些情况下，膜片920可以涂覆有抗血栓形成涂层，以帮助防止在膜片920上或上方的组织生长。
在图9的示例中，电池912被示出为邻近膜片920。然而，设想LCP 900的内部部件的许多不同配置。在所示的示例中，处理模块(例如，电路或控制电子装置)910被定位在壳体902的远端部分906中，邻近远端电极。一个或多个电导体924可以由具有在小于250微米范围内的截面尺寸的聚酰亚胺或类似的互连形成。可以预期的是，壳体902的内表面可以是电绝缘的，并且电导体924(例如，迹线)可以根据需要被定位在壳体902的内表面上或沿着电池912的外表面。替代地，可以使用电线或带状电缆。这些只是示例。
在一些情况下，电路910可以被配置为在一个或多个心动周期内以预定间隔获得压力测量结果。在其他情况下，电路910可以被配置为响应于特定心脏事件或在心动周期中的特定时间获得压力测量结果。例如，电路910可以被配置为使用由第一电极908和/或第二电极感测到的一个或多个心脏信号来确定患者的心脏何时处于心动周期的第一阶段。电路910可以被配置为至少部分地基于在心动周期的第一阶段期间获得的压力来确定壳体902外部的压力。在一些情况下，第一阶段可以是收缩期，而在其他情况下，第一阶段可以是舒张期。电路910也可以被配置为至少部分地基于在心动周期的第二阶段期间获得的压力来确定壳体902外部的压力。可以预期的是，电路910还可以被配置为至少部分地基于压力传感器输出信号来检测患者心脏的心音。例如，第一心音可以是用于压力突然增加的定时基准，而第二心音可以是用于压力突然减小的定时基准。
在一些情况下，LCP 900的电路910可以被配置为在一个或多个心动周期内获得多个压力读数。可以绘制压力读数(通过电路910或外部设备)以形成类似于图8中所示曲线图的曲线图。可以从曲线图推断出与心脏功能相关的各种参数，包括但不限于峰到峰值测量结果、dP/dT、时间平均值、心室的肌力反应等。在一些情况下，可以将压力测量结果与校准值(例如，在植入LCP 900时取得的测量结果)相比较。还可以预期的是，膜片920可以足够灵敏以响应于与LCP 900所植入的腔室不同的腔室中的压力增加而产生电压。例如，当LCP900被植入右心室中时，膜片可以响应于右心房中的压力增加(例如，心房强力收缩)以及右心室中的压力增加而产生电压。
在一些情况下，膜片920可以由与壳体902的其余部分相同的材料和相同的厚度形成。例如，壳体902可以弯曲或变形以将壳体902外部的压力传递到位于壳体612内的压电材料层。例如，壳体902可以具有顺应性(compliance)，使得壳体902响应于外部压力的相对移动可以被可操作地耦合到压电材料。由压电材料产生的所得电压(和/或电流)可以相对于在将LCP 900植入患者体内之前的外部压力进行校准。校准数据可以被存储在LCP 900的存储器和/或电路中。在一些情况下，取决于压电材料的放置，施加在壳体902上的压力与施加在压电材料上的压力之间可能存在(例如，在1-20％或更大的范围内的)一些压力损失。可通过使用存储在LCP 900中的校准数据，调节将压电材料产生的电压(和/或电流)转换为压力的算法，来补偿(例如，消除)该压力损失。
图10示出了具有膜片960和压电膜962的另一个说明性LCP 950的近端端部部分954。LCP 950在形式和功能上可以与上述的LCP 100、610、900类似。LCP 950可以包括以上关于LCP 100、610、900描述的模块和/或结构特征中的任一个。
说明性的LCP 950可以包括具有近端端部部分954和远端端部(未明确示出)的外壳或壳体952。壳体952可以包括面向近端的近端端部表面956(例如，在与远端端部表面大体相反的方向上)。在一些情况下，壳体952的近端端部表面956可以形成膜片960。在一些情况下，膜片960可以由壳体材料本身形成，但这不是要求的。当如此提供时，在膜片960的区域中的壳体的壁厚可以被减薄，以增加膜片960的柔性，但这不是要求的。在一些情况下，膜片960可以由另一种材料(诸如但不限于钛、钛箔、硅树脂、聚酰亚胺等)形成，以形成可变形或可移动的膜片960，膜片960响应于施加到膜片960的期望的压力范围。
在所示示例中，膜片960可弯曲或变形，并将从外部施加到壳体952的压力传递到位于壳体952内的压电材料层962。例如，壳体952可具有顺应性，使得壳体952和/或膜片960响应于外部压力的相对运动可使压电材料或膜962变形或以其他方式向压电材料或膜962施加相应的应力。在一些实施例中，压电膜962可以耦合到或定位在膜片960的内表面上，但这不是要求的。
当膜片960响应于外部压力而弯曲时，压电膜962也可能弯曲。施加到压电膜962的应力可在压电膜962的一侧上的第一传感器电极与压电膜962的相对侧上的第二传感器电极之间产生电压(和/或电流)。电压(和/或电流)可以经由一个或多个电导体964传输到LCP950的电路，在此其可以从电压(和/或电流)转换为压力读数。在一些情况下，一个或多个电导体964可以包括耦合到压电膜962的第一侧的第一电导体和耦合与第一侧相对的第二侧的第二电导体，使得产生的电压(和/或电流)被传输到电路。在一些情况下，电导体可以耦合到在968处总体上示出的第一传感器电极和第二传感器电极。
由压电材料产生的电压(和/或电流)可以相对于在将LCP 950植入患者体内之前施加的外部压力进行校准。校准数据可以被存储在LCP 950的存储器和/或电路中。在一些情况下，施加在壳体952上的压力与施加到压电膜962的压力之间可能存在(例如，在1-20％或更大的范围内的)一些压力损失。可通过使用存储在LCP 950中的校准数据，调节将压电膜962产生的电压(和/或电流)转换为压力的算法，来补偿(例如，消除)该压力损失。
在图10的示例中，电池966被示出为邻近膜片960。然而，设想LCP 950的内部部件的许多不同配置。在所示的示例中，处理模块(例如，电路或控制电子装置)可以被定位在壳体952的远端部分中，邻近远端电极。一个或多个电导体964可以由具有在小于250微米范围内的截面尺寸的聚酰亚胺或类似的互连形成。可以预期的是，壳体952的内表面可以是电绝缘的，并且电导体964(例如，迹线)可以根据需要被定位在壳体952的内表面上或沿着电池966的外表面。替代地，可以使用电线或带状电缆。这些只是示例。
图11示出了具有膜片1006和压电膜1010的另一个说明性LCP 1000的近端端部部分1004。LCP 1000在形式和功能上可以与上述的LCP 100、610、900类似。LCP 1000可以包括以上关于LCP 100、610、900描述的模块和/或结构特征中的任一个。
说明性的LCP 1000可以包括具有近端端部部分1004和远端端部(未明确示出)的外壳或壳体1002。壳体1002可以包括面向近端的近端端部表面1018(例如，在与远端端部表面大体相反的方向上)。在一些情况下，壳体1002的近端端部表面1018可以形成膜片1006。在一些情况下，膜片1006可以由壳体材料本身形成，但这不是要求的。当如此提供时，在膜片1006的区域中的壳体的壁厚可以被减薄，以增加膜片1006的柔性，但这不是要求的。在一些情况下，膜片1006可以由另一种材料(诸如但不限于钛、钛箔、硅树脂、聚酰亚胺等)形成，以形成可变形或可移动的膜片1006，膜片1006响应于施加到膜片1060的期望的压力范围。
膜片1006可弯曲或变形以将壳体1002外部的压力传递到位于壳体1002内的压电材料层或压电膜1010。例如，壳体1002可具有顺应性，使得壳体1002和/或膜片1006响应于外部压力的相对运动可机械地耦合到压电材料或膜1010。在一些实施例中，压电膜1010可以经由机械联动装置或臂1008耦合到膜片1006。这可以允许压电膜1010与壳体1002隔开一定距离，同时仍然响应于外部施加的压力1016而弯曲。在一些情况下，可能期望使用更刚性的压电材料，并且由机械联动装置或臂1008提供的机械杠杆作用可以允许向膜片1006施加更适度的外部压力，以使压电膜1010承受适当的应力，从而产生期望的电压(和/或电流)。在所示的示例中，当膜片1006响应于外部压力1016而弯曲时，联动装置1008也移动并将力传递至压电膜1010。施加到压电膜1010的力产生电压(和/或电流)，该电压(和/或电流)可以经由一个或多个电导体1012传递到LCP1000的电路，在此其从电压(和/或电流)转换为压力读数。在一些情况下，一个或多个电导体1012可以包括耦合到压电膜1010的第一侧的第一电导体和耦合到与压电膜1010的第一侧相对的第二侧的第二电导体，使得跨压电膜1010产生的电压(和/或电流)被传输到电路。在一些情况下，电导体可以耦合到被定位在压电膜1010的相对侧上的第一压力传感器电极和第二压力传感器电极。
由压电膜1010产生的所得电压可以相对于在将LCP 1000植入患者体内之前的外部压力进行校准。校准数据可以被存储在LCP 1000的存储器和/或电路中。在一些情况下，取决于联动装置或臂1008，施加在壳体1002上的压力与施加在压电膜1010上的压力之间可能存在(例如，在1-20％或更大的范围内的)一些压力损失。可通过使用存储在LCP 1000中的校准数据，调节将压电材料产生的电压(和/或电流)转换为压力的算法，来补偿(例如，消除)该压力损失。
在图11所示的示例中，电池1014被示出为邻近压电膜1010。然而，设想LCP 1000的内部部件的许多不同配置。在所示的示例中，处理模块(例如，电路或控制电子装置)可以被定位在壳体1002的远端部分中，邻近远端电极。一个或多个电导体1012可以由具有在小于250微米范围内的截面尺寸的聚酰亚胺或类似的互连形成。可以预期的是，壳体1002的内表面可以是电绝缘的，并且电导体1012(例如，迹线)可以根据需要被定位在壳体1002的内表面上或沿着电池1014的外表面。替代地，可以使用电线或带状电缆。这些只是示例。
图12示出了具有膜片1056和压电膜1062的另一个说明性LCP 1050的近端端部部分1054。说明性的LCP 1050在形式和功能上可以与上述的LCP 100、610、900类似。LCP 1050可以包括以上关于LCP 100、610、900描述的模块和/或结构特征中的任一个。
说明性的LCP 1050可以包括具有近端端部部分1054和远端端部(未明确示出)的外壳或壳体1052。壳体1052可以包括面向近端的近端端部表面1066(例如，在与远端端部表面大体相反的方向上)。在一些情况下，壳体1052的近端端部表面1066可以形成膜片1056。在一些情况下，膜片1056可以由壳体材料本身形成，但这不是要求的。当如此提供时，在膜片1056的区域中的壳体的壁厚可以被减薄，以增加膜片1056的柔性，但这不是要求的。在其他情况下，膜片1056可以由另一种材料(诸如但不限于钛、钛箔、硅树脂、聚酰亚胺等)形成，以形成可变形或可移动的膜片1056，膜片1056响应于施加到膜片960的期望的压力范围。
膜片1056可弯曲或变形以将壳体1052外部的压力传递到位于壳体1052内的压电材料层或压电膜1062。在所示的示例中，填充有流体1068的腔1064可以被定位在外部膜片1056和内部膜片1058之间。流体填充腔1064可与一个或多个膜片1056、1058流体连通，使得流体填充腔1064可将与由环境施加到壳体1052的膜片1056的压力1070有关的测量最终传送到压电膜片1062。流体填充腔1064可以填充有不可压缩的流体1068。在一些情况下，流体填充腔1064可以填充有非导电的流体1068。在一些情况下，可能出现在壳体内部的气体可以高度可溶于流体1068，特别是在体温(例如，37℃)下。例如，在壳体内部可能出现的氢气、氦气、氮气、氩气、水和/或其他气体或液体可以高度可溶于流体1068，因此例如对LCP 1050的内部部件进行除气。
膜片1056、1058可具有顺应性，使得壳体1052和/或膜片1056响应于外部压力的相对运动可有时通过机械联动装置或臂1060耦合到压电材料或膜1062。在图12中，示出了压电膜1062经由机械联动装置或臂1060机械地耦合到膜片内部膜片1058。然而，可以预期的是，压电材料或膜1062可以直接粘附到膜片内部膜片1058，或者膜片内部膜片1058可以由压电材料或膜1062制成或以其他方式形成压电材料或膜1062。
当膜片1056响应于外部压力1070弯曲时，力通过流体填充腔1064传递1072到膜片内部膜片1058。然后，膜片内部膜片1058有时通过机械联动装置或臂1060将力传递到压电材料或膜1062。施加到压电膜1062的力产生电压(和/或电流)。电压(和/或电流)可以经由一个或多个电导体1074传输到LCP 1050的电路，在此其被从电压(和/或电流)转换为压力读数。
在一些情况下，一个或多个电导体1024可以包括耦合到压电膜1062的第一侧的第一电导体和耦合到与压电膜1062的第一侧相对的第二侧的第二电导体，使得跨压电膜1062产生的电压(和/或电流)被传输到电路。在一些情况下，电导体可以耦合到被定位在压电膜1062的相对侧上的第一压力传感器电极和第二压力传感器电极。
由压电材料产生的电压可以相对于在将LCP 1050植入患者体内之前施加的外部压力进行校准。校准数据可以被存储在LCP 1050的存储器和/或电路中。在一些情况下，施加在壳体1052上的压力与施加到压电膜1062的压力之间可能存在(例如，在1-20％或更大的范围内的)一些压力损失。可通过使用存储在LCP 1050中的校准数据，调节将压电材料产生的电压(和/或电流)转换为压力的算法，来补偿(例如，消除)该压力损失。
在图12的示例中，电池1076被示出为邻近压电膜1062。然而，设想LCP 1050的内部部件的许多不同配置。在所示的示例中，处理模块(例如，电路或控制电子装置)可以被定位在壳体1052的远端部分中，邻近远端电极。一个或多个电导体1074可以由具有在小于250微米范围内的截面尺寸的聚酰亚胺或类似的互连形成。可以预期的是，壳体1052的内表面可以是电绝缘的，并且电导体1074(例如，迹线)可以根据需要被定位在壳体1052的内表面上或沿着电池1076的外表面。替代地，可以使用电线或带状电缆。这些只是示例。
图13示出了具有膜片1106和压电膜1108的另一个说明性LCP 1100的近端端部部分1104。LCP 1100在形式和功能上可以与上述的LCP 100、610、900类似。LCP 1100可以包括以上关于LCP 100、610、900描述的模块和/或结构特征中的任一个。
LCP 1100可以包括具有近端端部部分1104和远端端部(未明确示出)的外壳或壳体1102。壳体1102可以包括面向近端的近端端部表面1110(例如，在与远端端部表面大体相反的方向上)。在一些情况下，壳体1102的近端端部表面1110可以形成膜片1106。在一些情况下，膜片1106可以由壳体材料本身形成，但这不是要求的。当如此提供时，在膜片1106的区域中的壳体的壁厚可以被减薄，以增加膜片1106的柔性，但这不是要求的。在一些情况下，膜片1106可以由另一种材料(诸如但不限于钛、钛箔、硅树脂、聚酰亚胺等)形成，以形成可变形或可移动的膜片1106，膜片1106响应于施加到膜片1106的期望的压力范围。
膜片1106可弯曲或变形以将壳体1102外部的压力传递到位于壳体1102内的压电材料层或压电膜1108。在一些实施例中，填充有流体1114的腔1112可以定位在膜片1106和压电膜1108之间。流体填充腔1112被示出为与膜片1106流体连通，使得流体填充腔1112可将与环境施加的压力1116有关的测量传送到压电膜1108。流体填充腔1112可以填充有不可压缩的流体1114。在一些情况下，流体填充腔1112可以填充有非导电的流体1114。在一些情况下，可能在壳体内部的气体可以高度可溶于流体1114，特别是在体温(例如，37℃)下。例如，在壳体内部可能出现的氢气、氦气、氮气、氩气、水和/或其他气体或液体可以高度可溶于流体1114，因此例如对LCP 1100的内部部件进行除气。
膜片1106可具有顺应性，使得壳体1102和/或膜片1106响应于期望范围的外部压力的相对运动通过流体1114被耦合1118到压电材料或膜1108。施加到压电膜1108的力1118可以产生电压(和/或电流)。电压(和/或电流)可以经由一个或多个电导体1120传输到LCP1100的电路，在此其可以从电压(和/或电流)转换为压力读数。可以预期的是，在一些情况下，压电膜1108可以由压电材料形成，或者具有形成在另一种柔性材料的表面上的压电材料，例如参照图10所述。
在一些情况下，一个或多个电导体1120可以包括耦合到压电膜1108的第一侧的第一电导体和耦合到与压电膜1108的第一侧相对的第二侧的第二电导体，使得由压电材料或膜1108产生的电压(和/或电流)被传输到电路。在一些情况下，电导体可以耦合到被定位在压电膜1108的相对侧上的第一压力传感器电极和第二压力传感器电极。
由压电膜1108产生的电压(和/或电流)1108可以相对于在将LCP 1100植入患者体内之前施加的外部压力进行校准。校准数据可以被存储在LCP 1100的存储器和/或电路中。在一些情况下，施加在壳体1102上的压力与施加到压电膜1108的压力之间可能存在(例如，在1-20％或更大的范围内的)一些压力损失。可通过使用存储在LCP 1100中的校准数据，调节将压电膜1108产生的电压(和/或电流)转换为压力的算法，来补偿(例如，消除)该压力损失。
在图13的示例中，电池1122被示出为邻近压电膜1108。然而，设想LCP 1100的内部部件的许多不同配置。在所示的示例中，处理模块(例如，电路或控制电子装置)可以被定位在壳体1102的远端部分中，邻近远端电极。一个或多个电导体1120可以由具有在小于250微米范围内的截面尺寸的聚酰亚胺或类似的互连形成。可以预期的是，壳体1102的内表面可以是电绝缘的，并且电导体1120(例如，迹线)可以根据需要被定位在壳体1102的内表面上或沿着电池1122的外表面。替代地，可以使用电线或带状电缆。这些只是示例。
图14示出了另一说明性LCP 1150的近端端部部分1154的截面视图，其具有膜片1156和压电膜1158。LCP 1150在形式和功能上可以与上述的LCP 100、610、900类似。LCP1150可以包括以上关于LCP 100、610、900描述的模块和/或结构特征中的任一个。
LCP 1150可以包括具有近端端部部分1154和远端端部(未明确示出)的外壳或壳体1152。在该示例中，壳体1152包括从近端端部部分1154向近端延伸的对接构件1160。对接构件1160可以被配置为便于LCP 1150的递送和/或取出。例如，对接构件1160可以沿着壳体1152的纵轴从壳体1152的近端端部部分1154延伸。对接构件1160可以包括头部1162和在壳体1152和头部1162之间延伸的颈部1164。头部1162可以是相对于颈部1164的扩大部分。进入端口1166可以延伸穿过头部1162和颈部1164，以使膜片1156与心脏中的血液流体耦合。膜片1156可以使用本文所述的任何材料和/或配置来构造。替代地，膜片1156可以被定位在进入端口1166的近端开口1168处。
可以预期的是，对接构件1160可以形成为与壳体1152分离的结构，并且随后附接到壳体1152。例如，对接构件1160可以是被焊接(或以其他方式耦合或固定)到壳体1152的3D金属结构。在其他实施例中，对接构件1160和壳体1152可以形成为单个整体结构。
压电膜1158可以被定位在膜片1156附近，但不一定与膜片1058直接接触。在一些情况下，压电膜1158可以直接定位在膜片1156的内表面上，诸如关于图10所描述的。在其他实施例中，类似于上面描述的，压电膜1158可以通过机械联动装置和/或流体填充腔室机械地和/或流体地耦合到膜片1156。当膜片1156响应于外部压力而弯曲时，压电膜1158也可能弯曲。压电膜1158上的应力可产生电压(和/或电流)。电压(和/或电流)可以经由一个或多个电导体1170传输到LCP 1150的电路，在此其被从电压(和/或电流)转换为压力读数。在一些实施例中，压电膜1158可以可操作地连接到壳体1152，壳体1152又可操作地耦合到电路或控制电子装置。
在一些情况下，一个或多个电导体1170可以包括耦合到压电膜1158的第一侧的第一电导体和耦合到与压电膜1158的第一侧相对的第二侧的第二电导体，使得跨压电膜1158产生的电压(和/或电流)被传输到电路。在一些情况下，电导体可以耦合到被定位在压电膜1158的相对侧上的第一压力传感器电极和第二压力传感器电极。
图14示出了邻近压电膜1158的电池1172。然而，设想LCP 1150的内部部件的许多不同配置。一个或多个电导体1170可以由具有在小于250微米范围内的截面尺寸的聚酰亚胺或类似的互连形成。可以预期的是，壳体1152的内表面可以是电绝缘的，并且电导体1170(例如，迹线)根据需要被定位在壳体1152的内表面上或沿着电池1172的外表面。替代地，可以使用电线或带状电缆。这些只是示例。
图15示出了另一说明性LCP 1200的近端端部部分1204的截面视图，其具有膜片1206和压电膜1208。LCP 1200在形式和功能上可以与上述的LCP 100、610、900类似。LCP1200可以包括以上关于LCP 100、610、900描述的模块和/或结构特征中的任一个。
LCP 1200可以包括具有近端端部部分1204和远端端部(未明确示出)的外壳或壳体1202。壳体1202可以包括从近端端部部分1204向近端延伸的对接构件1210。对接构件1210可以被配置为便于LCP 1200的递送和/或取回。例如，对接构件1210可以沿着壳体1202的纵轴从壳体1202的近端端部部分1204延伸。对接构件1210可以包括头部1212和在壳体1202和头部1212之间延伸的颈部1214。头部1212可以是相对于颈部1214的扩大部分。进入端口1216可以延伸穿过头部1212和颈部1214，以使膜片1206与心脏中的血液流体耦合。膜片1206可以使用本文所述的任何材料和/或配置来构造。替代地，膜片1206可以被定位在进入端口1216的近端开口1168处。
可以预期的是，对接构件1210可以形成为与壳体1202分离的结构，并且随后附接到壳体1202。例如，对接构件1210可以是被焊接(或以其他方式耦合或固定)到壳体1202的3D金属结构。在其他实施例中，对接构件1210和壳体1202可以形成为单个整体结构。
压电膜1208可以被定位在膜片1206附近，但不一定与膜片1206直接接触。在一些实施例中，压电膜1208可以经由机械联动装置或臂1218耦合到膜片1206。压电膜1208的至少一部分可以相对于壳体1202保持在适当的位置，使得膜片1206和机械联动装置或臂1218相对于压电膜1208的运动在压电膜1208中引起应力。当膜片1206响应于外部压力1220而弯曲时，联动装置1218移动并将力传递至压电膜1208。施加到压电膜1208的力产生电压(和/或电流)。电压(和/或电流)可以经由一个或多个电导体1222传输到LCP 1000的电路，在此其被从电压(和/或电流)转换为压力读数。
在一些情况下，一个或多个电导体1222可以包括耦合到压电膜1208的第一侧的第一电导体和耦合到与压电膜1208的第二相对侧的第二电导体，使得跨压电膜1208产生的电压(和/或电流)被传输到电路。在一些情况下，电导体可以耦合到被定位在压电膜1208的相对侧上的第一压力传感器电极和第二压力传感器电极。
图15示出了邻近压电膜1208的电池1224。然而，设想LCP 1200的内部部件的许多不同配置。一个或多个电导体1222可以由具有在小于250微米范围内的截面尺寸的聚酰亚胺或类似的互连形成。可以预期的是，壳体1202的内表面可以是电绝缘的，并且电导体1222(例如，迹线)根据需要被定位在壳体1202的内表面上或沿着电池1224的外表面。替代地，可以使用电线或带状电缆。这些只是示例。
可以预期的是，本文所描述的任何实施例都可以修改为包括多个(例如，两个或更多个)膜片和/或压电膜，以提高压力读数的灵敏度。例如，可能期望一个或多个膜片具有尽可能大的表面积。这可以通过单个大膜片或多个小膜片来完成。还应当理解，膜片和/或压电膜的放置不限于LCP的近端端部区域。在一些情况下，膜片和/或压电膜可被定位在侧壁中或邻近侧壁和/或在远端端部区域附近。
在一些情况下，膜片和/或压电膜可以包括被配置为增加膜片和/或压电膜的灵敏度和/或线性度的轮廓。一些说明性的轮廓可以包括但不限于凹面、凸面、起伏表面、具有大致凹形的中央区域的大致凸形的表面等。可以预期的是，可以针对设备的应用和/或放置调整轮廓。
不管LCP的放置位置如何，在植入设备时都可能向膜片和/或压电膜施加一定的静压。这可能导致膜片和/或压电膜从其未植入时的配置弯曲。LCP可以被配置为检测由膜片的运动所指示的压力随时间的变化。这样，并且在一些情况下，可能期望在植入LCP时预先调节膜片和/或压电膜以优化膜片和/或压电膜的压力范围。这可以通过在制造过程中使膜片和/或压电膜沿与由心脏的腔室施加的静压相反的方向变形，使得膜片和/或压电膜在植入后处于中性配置(而不是在植入腔室的静压下向内弯曲)来实现。
本领域技术人员将认识到，可以以除本文所描述和设想的特定示例之外的各种形式来表现本公开。例如，如本文描述的，各种示例包括被描述为执行各种功能的一个或多个模块。然而，其他示例可以包括将所描述的功能拆分在比本文描述的更多模块上的附加模块。另外，其他示例可以将所描述的功能合并为更少的模块。因此，在不脱离如在所附权利要求中描述的本公开的范围和精神的情况下，可以做出形式和细节上的偏离。
Claims (15)
1.一种无引线心脏起搏器(LCP)，其被配置为感测心脏活动并向患者心脏递送起搏治疗，所述LCP包括：
壳体，其具有近端端部和远端端部；
第一电极，其相对于所述壳体固定并且暴露于所述壳体外部的环境；
第二电极，其相对于所述壳体固定并且暴露于所述壳体外部的环境；
膜片，其暴露于所述壳体外部的环境，所述膜片响应于由所述壳体外部的环境施加到所述膜片的外部压力；
压电膜，其具有第一压力传感器电极和第二压力传感器电极，所述压电膜被配置为响应于施加到所述膜片的压力变化而在所述第一压力传感器电极和所述第二压力传感器电极之间产生电压，所述电压表示施加到所述膜片的外部压力变化；以及
所述壳体中的电路，其被可操作地耦合到所述LCP的所述第一电极和所述第二电极，并且还可操作地耦合到所述第一压力传感器电极和所述第二压力传感器电极，所述电路被配置为经由所述LCP的所述第一电极和所述第二电极向患者的心脏递送起搏治疗，其中所述起搏治疗至少部分取决于由所述压电膜产生并且表示施加到所述膜片的外部压力变化的电压。
2.根据权利要求1所述的LCP，其中，所述电路被配置为通过监视由所述压电膜在所述第一压力传感器电极和所述第二压力传感器电极之间产生的电压来检测压力脉冲。
3.根据权利要求1-2中任一项所述的LCP，其中，所述膜片具有面向所述壳体内部的内表面，并且所述压电膜被固定到所述膜片的所述内表面的至少一部分。
4.根据权利要求1-2中任一项所述的LCP，其中，所述膜片具有面向所述壳体内部的内表面，并且所述压电膜与所述膜片的所述内表面间隔开一定距离，并经由不可压缩的流体可操作地耦合到所述膜片的所述内表面。
5.根据权利要求4所述的LCP，其中，所述不可压缩的流体在至少部分地由所述膜片的所述内表面限定的流体腔中，并且与所述膜片的所述内表面和所述压电膜两者都流体连通，其中，所述流体腔被配置为将由所述膜片施加到不可压缩的流体的压力传送到所述压电膜。
6.根据权利要求1-2中任一项所述的LCP，其中，所述膜片具有面向所述壳体内部的内表面，并且所述压电膜与所述膜片的所述内表面间隔开一定距离，并经由机械联动装置可操作地耦合到所述膜片的所述内表面，其中所述机械联动装置被配置为将所述膜片的运动转换成施加到所述压电膜的压力。
7.根据权利要求1-6中任一项所述的LCP，其中，所述壳体的所述膜片包括一个或多个轮廓。
8.根据权利要求1-7中任一项所述的LCP，其中，所述电路被配置为检测由心脏的第二腔室的收缩引起的心脏的第一腔室中的压力变化。
9.根据权利要求8所述的LCP，其中，所述第一腔室是心室，并且所述第二腔室是对应的心房。
10.根据权利要求1-9中任一项所述的LCP，其中，所述膜片与所述壳体一体形成。
11.根据权利要求1-10中任一项所述的LCP，其中，所述膜片被气密密封在所述壳体上。
12.根据权利要求1-11中任一项所述的LCP，还包括处于所述壳体的所述远端端部处的固定构件，其用于将所述壳体的所述远端端部固定到植入部位，并且其中所述壳体的所述膜片邻近所述壳体的所述近端端部。
13.根据权利要求1-12中任一项所述的LCP，其中，所述壳体包括细长主体，其具有面向远端的远端端部表面和面向近端的近端端部表面，其中所述壳体的所述膜片位于所述壳体的所述近端端部表面上。
14.根据权利要求1-13中任一项所述的LCP，其中，所述膜片和/或所述压电膜被形成为使在植入时所述膜片和/或所述压电膜的动态变化最大化。
15.根据权利要求1-14中任一项所述的LCP，还包括被布置在所述壳体的所述膜片上方的抗血栓形成涂层。
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| EP3668592A1 (en) | 2020-06-24 |
| EP3668592B1 (en) | 2021-11-17 |
| US11065459B2 (en) | 2021-07-20 |
| CN111032148B (zh) | 2024-04-02 |
| WO2019036600A1 (en) | 2019-02-21 |
| US20210308467A1 (en) | 2021-10-07 |
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