CN109562269A - 经隔膜可植入医疗设备 - Google Patents
经隔膜可植入医疗设备 Download PDFInfo
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Abstract
可植入医疗设备(IMD)包括壳体，其被配置成至少部分地定位在心脏腔室中，并且在一些情况下，在右心室(RV)中接近心脏的心室隔膜的RV面向侧。当这样设置时，RV电极可相对于壳体固定，以接近心室隔膜的RV面向侧。LV电极可以与RV电极和壳体间隔开一定距离，使得LV电极至少部分地定位在心室隔膜内。LV电极位置调节组件可用于调节LV电极在心室隔膜内定位的深度。
Description
相关申请的交叉引用
本申请要求于2016年8月19日提交的美国临时专利申请序列号62/377,204的权益，其公开内容通过引用并入本文。
技术领域
本公开一般涉及可植入医疗设备，并且更具体地涉及可以至少部分地延伸穿过患者心脏内的隔膜的可植入医疗设备。
背景技术
目前，可植入医疗设备通常用于监视患者和/或向患者递送治疗。例如，可植入传感器通常用于监视患者的一个或多个生理参数，例如心搏、心音、ECG、呼吸等。在另一个示例中，起搏设备通常用于治疗患有各种心脏病的患者，心脏病可能导致心脏向患者体内递送足够量血液的能力降低。这种心脏病可能导致缓慢、快速、不规则和/或低效的心脏收缩。为了帮助减轻这些病症中的一些，可以将各种医疗设备(例如，起搏器、除颤器等)植入患者体内。这样的设备可以监视并且在一些情况下向心脏提供电刺激以帮助心脏以更正常、有效和/或安全的方式操作。在一些情况下，可以有益的是感测和/或调节心脏的两个或更多个腔室。
发明内容
本公开一般涉及可植入医疗设备，并且更具体地涉及可至少部分地延伸穿过患者心脏内的隔膜植入医疗设备。在一些情况下，可植入医疗设备可以被配置成邻近患者心脏内的隔膜设置。在一些情况下，可植入医疗设备可以被配置成至少部分地延伸到隔膜中，并且在一些情况下，完全穿过隔膜。隔膜可以是将左心室和右心室分开的心室隔膜。当如此提供时，可植入医疗设备可以被配置为感测心脏的两个心室和/或调整心脏的两个心室的搏动。在一些情况下，可植入医疗设备可以经由心脏更容易接近的右心室递送到心室隔膜。在一些情况下，隔膜可以是将左心房和右心房分开的心房隔膜。在一些情况下，隔膜可以是在右心房和左心室之间延伸的心房/心室隔膜。这些只是示例。
在本公开的一个示例中，可植入医疗设备(IMD)被配置用于部署在患者心脏的心室隔膜上，所述患者心脏的心室隔膜具有右心室(RV)面向侧和左心室(LV)面向侧。IMD可以包括壳体，其具有近端和远端，IMD被配置成至少部分地定位在患者心脏的右心室(RV)中，其中一旦所述IMD植入在患者的心脏中所述壳体的远端就接近所述心室隔膜的RV面向侧。IMD可以包括设置在壳体内的电源，以及也设置在壳体内并且可操作地耦合到电源的电路。第一RV电极可以设置为邻近所述壳体的远端并且一旦植入所述IMD就定位成面向所述心室隔膜的RV的面向侧。第一RV电极可以与壳体中的电路可操作地耦合。第二RV电极可以与所述第一RV电极接近地间隔开，并且可以与所述壳体中的电路可操作地耦合。LV电极远离所述第一RV电极定位并且一旦植入所述IMD就至少部分地位于所述心室隔膜中。LV电极与所述壳体中的电路可操作地耦合。IMD可以包括LV电极位置调节组件，用于调节所述LV电极远离所述第一RV电极定位的距离。LV电极位置调节组件可以包括相对于壳体固定的联接器，该联接器配置成与单独的调节工具配合，其能够使所述联接器相对于所述壳体移动以调节所述LV电极远离所述第一RV电极定位的距离。
作为上述任何实施例的替代或补充，LV电极位置调节组件可以包括远离所述壳体延伸的固定螺旋件，其中LV电极定位在固定螺旋件上。固定螺旋件包括接近轴部分，其延伸穿过所述壳体的内腔并且在所述联接器中终止，使得旋转所述联接器使所述固定螺旋件相对于所述壳体旋转，并使所述固定螺旋件自身旋入所述心室隔膜中。
作为上述任何实施例的替代或补充，LV电极位置调节组件可包括可操作地耦合到联接器的内轴和与内轴螺纹接合并且被配置成不相对于壳体旋转的外轴，其中内轴经由所述联接器的旋转导致所述外轴相对于所述壳体的平移。LV电极可以相对于所述外轴固定和随着所述外轴平移。
作为上述任何实施例的替代或补充，外轴的至少一部分具有横截面轮廓，所述横截面轮廓接合所述壳体的互补接合部分以防止所述外轴相对于所述壳体旋转。
作为上述任何实施例的替代或补充，横截面轮廓可包括非圆形横截面轮廓，并且壳体的互补接合部分可包括内腔中的远离开口，其接收至少部分外轴。
作为上述任何实施例的替代或补充，联接器可包括耦合到所述内轴的近端的可旋转的系绳环，使得旋转所述可旋转的系绳环使所述内轴相对于所述外轴旋转，从而引起所述外轴平移以作为响应。
作为上述任何实施例的替代或补充，IMD还可包括弹簧触头，所述弹簧触头设置在所述壳体内并且与所述电路可操作地耦合，所述弹簧触头与所述外轴中的与所述LV电极电耦合的部分滑动电接触。
作为上述任何实施例的替代或补充，IMD可进一步包括一个或多个固定齿，所述固定齿被配置成延伸到所述心室隔膜中并弯曲以将所述IMD相对于所述心室隔膜锚定就位。
作为上述任何实施例的替代或补充，电源可包括电池。
作为上述任何实施例的替代或补充，IMD可以是双室无引线心脏起搏器(LCP)。
在本公开的另一个示例中，可植入医疗设备(IMD)可以被配置为部署在患者心脏的心腔内、患者心脏的隔膜附近。患者心脏的隔膜具有面向心腔的第一腔室面向侧和第二相对腔室面向侧。IMD可以包括壳体，其被配置成一旦所述IMD植入患者心脏中就至少部分地定位在接近隔膜的第一腔室面向侧的心脏中。IMD还可以包括设置在壳体内的电源。电路可以设置在壳体内，并且可以可操作地耦合到电源。与壳体中的电路可操作地耦合的一个或多个第一腔室电极可以相对于壳体固定，并且一旦植入IMD就可以定位成接近心室的第一腔室面向侧。壳体可以限定内腔，并且IMD可以包括外轴，外轴延伸穿过内腔并且可相对于内腔平移。第二腔室电极可以设置在所述外轴的远端处或其附近，并且可以与设置在所述壳体内的电路可操作地耦合。内轴可以与所述外轴螺纹接合使得所述内轴可相对于所述外轴旋转，以实现所述外轴相对于所述壳体的平移。外轴可以在其中所述第二腔室电极接近隔膜的第一腔室面向侧的缩回位置和其中所述第二腔室电极至少部分地延伸到隔膜中的延伸位置之间平移。
作为上述任何实施例的替代或补充，外轴的至少一部分可具有横截面轮廓，所述横截面轮廓与所述壳体的互补接合部分接合，以防止所述外轴相对于所述壳体旋转。
作为上述任何实施例的替代或补充，内轴可以接近地延伸穿过所述内腔并且在所述联接器中终止，使得旋转所述联接器使所述内轴相对于所述外轴旋转。
作为上述任何实施例的替代或补充，IMD还可包括一个或多个固定齿，其被配置成延伸到所述隔膜中并弯曲以将所述IMD相对于所述隔膜锚定就位。
作为上述任何实施例的替代或补充，IMD还可包括弹簧触头，所述弹簧触头设置在所述壳体内并与所述电路可操作地耦合，所述弹簧触头使得与所述外轴的中与所述第二腔室电极电耦合的部分滑动电接触。
作为上述任何实施例的替代或补充，LV电极可以用作用于通信目的的天线。
作为上述任何实施例的替代或补充，IMD可以是双腔无引线心脏起搏器(LCP)，并且LCP可以感测心室隔膜的一侧上的电活动并且在心室隔膜的另一侧上递送可行动的响应。
在本公开的另一个示例中，一种促进心脏的双腔起搏的方法可以包括将可植入医疗设备(IMD)推进到接近心脏隔膜的第一侧的位置，IMD包括壳体和相对于壳体设置的两个第一腔室电极，IMD还包括第二腔室电极和电极位置调节组件，其具有用于调节第二腔室电极相对于壳体的位置的联接器。调节工具可以配合到电极位置调节组件的联接器，并且可以操纵调节工具以使联接器相对于壳体移动，以调节第二腔室电极相对于壳体的位置。可以部署固定机构以相对于隔膜固定IMD。
作为上述任何实施例的替代或补充，该方法可以进一步包括在部署固定机构之前测试心脏的捕获，如果没有实现捕获，则将IMD移动到接近隔膜的第一侧的不同位置，并再次测试捕获。
作为上述任何实施例的替代或补充，该方法可以进一步包括测试捕获，其中第二腔室电极相对于壳体定位在第一距离处，操纵调节工具以相对于壳体移动联接器以调节第二腔室电极相对于壳体定位在第二距离的距离，并再次测试捕获。
以上发明内容并非旨在描述本公开的每一个和每种公开的实施例或每种实施方式。下面的附图和描述更具体地举例说明了这些和其他说明性实施例。
附图说明
考虑到以下结合附图的描述，可以更全面地理解本公开，其中：
图1是人心脏的示意图；
图2是根据本公开的可植入医疗设备(IMD)的示意性框图。
图3是根据本公开的可植入医疗设备(IMD)的示意性框图。
图4是图3的IMD的一部分的放大端视图；
图5是另一示例调节机构的示意性框图；
图6是根据本公开的作为无引线心脏起搏器(LCP)的IMD的透视图；
图7是图6的IMD的横截面图；
图8是图6的IMD的一些组件的示意图；
图9是根据本公开的与递送设备组合的IMD的示意图；
图10是说明性无引线心脏起搏器(LCP)的示意性框图，其可被视为图2、3和6的IMD中的一个的示例；
图11是示出促进双室心脏起搏的说明性方法的流程图；
图12是示出促进双室心脏起搏的另一说明性方法的流程图；和
图13是示出促进双室心脏起搏的另一说明性方法的流程图。
虽然本公开可以进行各种修改和替换形式，但是其细节已经通过附图中的示例示出并且将被详细描述。然而，应该理解，意图不是将本公开限制于所描述的特定实施例。相反，意图是覆盖落入本公开的精神和范围内的所有修改、等同物和替代物。
具体实施方式
对于以下定义的术语，应当应用这些定义，除非在权利要求或本说明书的其他地方给出不同的定义。
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述值的数字范围(即，具有相同的功能或结果)。在许多情况下，术语“约”可以包括舍入到最靠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，单数形式“一”、“一个”和“该”包括复数指示物，除非内容另有明确说明。如在本说明书和所附权利要求中所使用的，术语“或”通常以包括“和/或”的含义使用，除非内容另有明确说明。
应注意，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特定的特征、结构和/或特性。另外，当结合一个实施例描述特定特征、结构和/或特性时，应该理解，这些特征、结构和/或特性也可以与其他实施例结合使用，无论是否明确描述除非明确说明与此相反。
应参考附图阅读以下描述，其中不同附图中的类似结构编号相同。不一定按比例绘制的附图描绘了说明性实施例，并且不旨在限制本公开的范围。
图1是人心脏H的示意图。心脏H包括相对于人的视角的右侧和左侧。心脏H的右侧包括RA(右心房)和RV(右心室)。心脏H的左侧包括LA(左心房)和LV(左心室)。心室隔膜10将RV和LV隔开，并且心房隔膜11将RA和LA隔开。心脏H也可以被认为包括RA和LV之间的房室隔膜17。心室隔膜10可以被认为具有RV面向侧12和LV面向侧14。心房隔膜11可以被认为包括RA面向侧13和RA面向侧15。
已知包括心室隔膜10的心脏壁的部分具有导致RV和LV收缩所涉及的传导通路。在一些情况下，通过脉管系统到达RV，例如通过上腔静脉或下腔静脉并通过右心房(未示出)，可能比在血管内途径中到达LV更容易。在一些情况下，由于在心脏H内放置和操纵可植入设备，可能在心脏H内形成碎屑(debris)。在一些情况下，RV内的碎片对于患者而言可能比LV内的碎屑带来更少问题，因为RV内的碎屑可以进入患者的肺部，其可以充当过滤器，而LV内的潜在碎屑可以直接进入患者的大脑，潜在地导致中风或其他并发症。此外，在一些情况下，由于身体对异物的存在的自然反应，心脏H内存在重要的异物(例如可植入医疗设备)可能导致组织向内生长和/或凝结发生。如果释放，这样的凝结在RV中比在LV中更少关注。
在一些情况下，可植入医疗设备(IMD)可被配置成部署在RV内、部署在心室隔膜10的RV面向侧12附近或接近其部署。在一些情况下，如将讨论的，IMD可以附加地或替代地部署在RA内部、部署在心房隔膜11的RA面向侧13附近或接近其部署。在一些情况下，IMD的一部分可以例如部分地延伸到心室隔膜10中，或甚至完全延伸穿过心室隔膜10，以便将一个或多个电极放置在适当位置以捕获通过心室隔膜10的控制LV的收缩的上述传导通路，或以其他方式在LV内感测或起搏。应当理解，在一些情况下，可以使穿入LV的IMD的一部分或多个部分的尺寸最小化，以便最小化身体对这种异物的自然反应。在一些情况下，穿入LV的IMD的一部分或多个部分，并且在一些情况下甚至是保留在RV内的IMD的一部分或多个部分，可以涂覆有或以其他方式包括一种或多种抗凝血材料或者促进暴露于腔室中血流的表面的内皮化的材料。
图2是示例性IMD 20的高度示意图，该IMD 20例如可以接近心室隔膜10的RV面向侧12被使用。在一些情况下，可以设想IMD 20可以接近心房隔膜11的RA面向侧13被使用。在一些情况下，隔膜可以是在右心房RA和左心室LV之间的心房/心室隔膜17。
在一些情况下，IMD 20可包括壳体22，壳体22可被视为包括近端21和远端23。壳体22可例如配置成至少部分地设置在RV内，例如，壳体22的远端23在心室隔膜10的RV面向侧12附近或接近其。
电源24可以设置在壳体22内。在一些情况下，电源24可以是电池。在一些情况下，电源24可以是可再充电电源，例如可再充电电池，例如超级电容器的电容器和/或能够获取从另一设备无线传输的电力的任何其他合适的可再充电电源或源。在一些情况下，例如，能量可以经由RF功率传送而被传输到电源24。电路26可以设置在壳体22内并且可以可操作地耦合到电源24，使得电源24可以为电路26的操作供电。在一些情况下，如果电源24是可再充电的，则电路26也可以调整电源24的再充电操作。在一些情况下，电路26可以包括或耦合到天线、电感回路和/或用于无线地接收能量以对电池再充电的其他能量接收元件。在一些情况下，可以从身体运动中获取能量。
在一些情况下，如图所示，IMD 20可包括与壳体22的远端23邻近的第一RV电极28。应当理解，第一RV电极28相对于壳体22定位使得一旦已经植入IMD 20第一RV电极28就将面向心室隔膜10的RV面向侧12。第一RV电极28经由导体30与电路26可操作地耦合。第二RV电极32可以与第一RV电极28接近地间隔开，并且可以经由导体34与电路26可操作地耦合。
在一些情况下，IMD 20可以包括LV电极36，如可以看到的，LV电极36可以远离第一RV电极28定位。在一些情况下，一旦植入IMD 20，LV电极36就可以定位成使得LV电极36至少部分地穿入心室隔膜10中。在一些情况下，LV电极36可以仅部分地延伸到心室隔膜10中。在一些情况下，LV电极36可以一直延伸穿过心室隔膜10并且实际上可以定位在心室隔膜10的LV面向侧14处。LV电极36可以经由导体38与电路26可操作地耦合。在一些情况下，IMD 20可以包括LV电极位置调节组件40，其在图2中示意性地示出。如将关于随后的附图所示，LV电极位置调节组件40可以是长度可调节的，以便调节LV电极36相对于壳体22的位置，从而调节LV电极36穿入心室内的相对深度。在一些情况下，LV电极36可以用作用于通信目的的天线。
在一些情况下，LV电极位置调节组件40可包括螺纹机构，其在旋转时使LV电极36向外移动以进一步穿入心室隔膜10中。在一些情况下，LV电极位置调节组件40可以包括推杆，其在被推动设备(例如，递送心轴或导管)推动时使LV电极36向外移动以进一步穿入心室隔膜10中。在一些情况下，可以提供锁定机构来将LV电极36的位置保持在适当位置。在一些情况下，LV电极位置调节组件40可以压缩，并因此可以在缩回位置呈现较短的轮廓。在一些情况下，LV电极位置调节组件40可包括液压机构，该液压机构在被激活时使LV电极36向外移动以进一步穿入心室隔膜10中。在一些情况下，LV电极位置调节组件40可包括电动机，其配置成向外驱动LV电极36以进一步穿入心室隔膜10中。在一些情况下，LV电极位置调节组件40可包括螺线管以向外驱动LV电极36以进一步穿入心室隔膜10中。这些仅是LV电极位置调节组件40的植入的一些示例。在一些情况下，LV电极位置调节组件40可以被配置成还使LV电极36相对于心室隔膜10并朝向壳体22缩回。当如此提供时，LV电极36在心室隔膜10中的定位可以在接近和远离的方向上可调节。在一些情况下，例如，IMD 20可以感测心脏H的一个部分中的电活动并且将可行动的响应(例如但不限于起搏)递送到心脏H的另一部分。例如，IMD 20可以例如经由RV电极28感测心室隔膜10的RV面向侧12上的电活动，并且可以使用LV电极36在心室隔膜10的LV面向侧14上起搏。
图3是IMD 50的高度示意性图示，IMD 50可以被配置为部署在患者心脏的心腔内、在心脏的隔膜附近。隔膜可以被认为具有面向心室的第一腔室面向侧和第二相对腔室面向侧。在一些情况下，心室可以是RV，并因此所讨论的隔膜是心室隔膜10，其具有RV面向侧12和LV面向侧14。这仅仅是说明性的，因为例如IMD 50可以是可植入在RA内，意味着所讨论的隔膜是心房隔膜11，具有RA面向侧13和LA面向侧15。IMD 50包括具有近端51和远端53的壳体52。
IMD 50可以包括一个或多个第一腔室电极54，其相对于壳体52固定，并且一旦植入IMD就定位成接近于心腔室的第一腔室面向侧。如图所示，IMD 50包括第一腔室电极54a和第二腔室电极54b。第一腔室电极54a可以经由导体56a与电路26可操作地耦合。第二腔室电极54b可以经由导体56b与电路26可操作地耦合。
在一些情况下，内腔58可以从近端51延伸穿过壳体52到达远端53。可以看出，调节机构60可以延伸穿过内腔58。在一些情况下，调节机构60可以被认为是图2中参考的LV电极位置调节组件40的示例。可以看到第二腔室电极62设置在调节机构60的远端63处或附近，并且可以经由导体64(部分以虚线示出)与电路26可操作地耦合。在一些情况下，调节机构60可包括延伸穿过内腔58的外轴66，并且如将讨论的可相对于内腔58和壳体52可平移。调节机构60可包括内轴68，其与外轴66螺纹接合，使得内轴68可相对于外轴66旋转，以实现外轴66相对于壳体52的平移。在一些情况下，外轴66可在其中第二腔室电极62接近隔膜的第一腔室面对侧的缩回位置和其中第二腔室电极62至少部分地延伸到隔膜中的伸出位置之间可平移。在一些情况下，可以提供多个第二腔室电极62，每个第二腔室电极62沿着外轴66处于不同的位置，使得每个第二腔室电极在隔膜中处于不同的深度。电路26可以包括选择器(未明确示出)，以选择使用多个第二腔室电极62中的哪一个(或多个)。
外轴66可涂覆有类固醇或其他物质以使炎症最小化。在一些情况下，外轴66可在其远端处具有无创伤尖端。无创伤尖端可以是半柔性的并且可以是圆形的以避免切割心肌。在一些情况下，外轴可以包含固定元件，例如从外轴66的侧壁横向延伸出的柔性爪。这种固定元件可以提供额外的稳定性并且可以用于补充或代替固定齿104(见图6)和/或锚216(见图10)。在一些情况下，例如，一个或多个固定元件可以是电活性的。
在一些情况下，外轴66可以被限制以防止相对于壳体52旋转。通过保持外轴66不相对于壳体52旋转，使内轴68相对于外轴66旋转(和相对于壳体52)可以使外轴66平移而不旋转。在一些情况下，沿第一方向旋转内轴68可使外轴66沿远离方向平移，而内轴68沿第二相反方向旋转可使外轴66沿接近方向平移。在一些情况下，外轴66或外轴66的至少一部分可具有与壳体52的互补接合部分接合的横截面轮廓，以防止外轴66相对于壳体52旋转，同时仍然允许外轴66相对于壳体52平移。图4提供了图3的壳体52的远端53的一部分的放大视图。外轴66示出为具有横截面轮廓，例如但不限于非圆形横截面轮廓，其形状与孔70相互补，孔70表示内腔58的远端。应当理解，这仅是外轴66相对于孔70的外轮廓之间的适当关系的一个示例。
返回到图3，调节机构60可包括联接器72，联接器72可例如刚性地耦合到内轴68，使得联接器72的旋转产生内轴68的旋转。联接器72可以被配置成使得单独的调节工具可以与联接器72配合。在一些情况下，调节工具可用于旋转联接器72以旋转内轴68。在一些情况下，联接器72可以例如表示系绳环。旋转系绳环可以使内轴68沿与系绳环相同的方向旋转，并且内轴68相对于外轴66旋转，同时外轴66被限制旋转导致外轴相对于壳体52的平移。根据所使用的LV电极位置调节组件40的类型，可以设想，联接器可以是机械联接器、电联接器、液压联接器和/或根据需要的任何其它合适的联接器。
转到图5，并且在一些情况下，预期的是调节机构60可包括固定螺旋件。
图5示出了外轴76，其包括轴部分78和螺旋部分80。在一些情况下，轴部分78与内轴68螺纹接合。在一些情况下，轴部分78与内轴68刚性耦合并且轴部分78针对旋转不受限制。在一些情况下，内轴68和轴部78可以被认为形成接近轴部分，该接近部分接近地延伸回到联接器72(图3)。结果，并且在一些情况下，内轴68的旋转可以引起外轴76的旋转，使得螺旋部分80能够将其自身扭曲或拧入隔膜中。在一些情况下，螺旋部分80可以焊接或焊到内轴68。在一些情况下，螺旋部分80可以整体形成为内轴68的一部分。在一些情况下，第二腔室电极62可以设置在螺旋部分80的远端83处或附近，并且可以可操作地耦合到电路26。在一些情况下，可以提供多个第二腔室电极62，每个第二腔室电极62沿着螺旋部分80处于不同的位置，使得每个第二腔室电极62在隔膜中处于不同的深度。电路26可以包括选择器(未在图3中明确示出)以选择使用多个第二腔室电极62中的哪一个(或多个)。
图6提供了作为无引线心脏起搏器(LCP)的IMD 90的图示。IMD 90包括从近端91延伸到远端93的壳体92。系绳环94相对于近端91固定，并且例如可以被认为是联接器72的示例(图3)。系绳环94可以例如用于在植入期间相对于递送设备保持IMD 90，并且可以与调节工具接合以旋转系绳环94。在远端93处，承载LV电极98的外轴96远离远端93延伸。第一RV电极100可以设置在壳体92的远端93处或附近。在一些情况下，如图所示，第二RV电极102可以设置在壳体92的近端91处或附近。在一些情况下，第二RV电极102可以是环形电极，但这不是必需的。IMD 90包括固定齿104，其可被配置成延伸到心肌中然后自身弯曲(如图所示)以将IMD 90锚固到心脏。
图7是沿图6的线7-7截取的说明性IMD 90的横截面图。可以看出，内轴106与外轴96螺纹接合并接近地延伸至系绳环94使得系绳环94的旋转使得内轴106相对于外轴96旋转。如果外轴96被限制为不相对于壳体92旋转(例如，如关于图4所讨论的)，则取决于内轴106和外轴96的螺纹方向，以及系绳环94旋转的方向，系绳环94相对于壳体92的旋转将使外轴96远离地或接近地平移。
应当理解，在电路26(图2、3和7)与LV电极98之间需要电连接。如图7中示意性所示，连接器110提供电路26和移动的外轴96之间的电连接。图8提供了关于连接器110的说明性但非限制性示例的更多细节。在一些情况下，弹簧触点112可以与电路26耦合。弹簧触点112可以使与LV电极98电耦合的外轴96的一部分滑动电接触。
图9提供了将IMD 90植入接近于心室隔膜10的示例。如图所示，第一RV电极100和第二RV电极102都是环形电极，但这不是必需的。IMD 90固定在递送设备120内，递送设备120包括植入工具122，植入工具122在递送设备120内延伸并且可用于多种目的。例如，植入工具122可以接合系绳环94以相对于递送设备120保持IMD 90，同时将IMD 90递送到植入部位。在一些情况下，植入工具122可以随后用于相对于IMD 90的壳体旋转系绳环94，从而延伸或缩回承载LV电极98的外轴96。如图所示，LV电极98接近于心室隔膜10的LV面向侧14。在一些情况下，LV电极98可以替代地设置在心室隔膜10内、在心室隔膜10的RV面向侧12和心室隔膜10的LV面向侧14之间的中间深度处。在一些情况下，可以提供多个LV电极，每个LV电极在沿着外轴96的不同位置处，使得每个LV电极在心室隔膜10中处于不同的深度。电路26可以包括选择器(未明确示出)以选择使用多个LV电极中的哪一个(或多个)。
图10是说明性IMD的概念性示意性框图，并且更具体地是无引线心脏起搏器(LCP)，其可操作以感测生理信号和参数并将一种或多种类型的电刺激治疗递送至患者心脏。示例性电刺激治疗可包括心动过缓起搏、心率响应起搏治疗、心脏再同步治疗(CRT)、抗心动过速起搏(ATP)治疗和/或类似治疗。如在图10中可以看到的，LCP 200可以是紧凑型设备，其中所有组件都容纳在LCP 200内或直接在壳体220上。在一些情况下，LCP 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、能量存储模块212和电极214中的一个或多个。LCP 200可以例如被视为IMD 20(图2)、IMD 50(图3)和/或IMD 90(图6)的示例。
如图10中所描绘的，LCP 200可以包括电极214，其可以相对于壳体220固定并且电暴露于LCP 200周围的组织和/或血液。电极214通常可以将电信号传导到LCP 200和周围组织和/或血液和从LCP 200和周围组织和/或血液传导电信号。这样的电信号可以包括通信信号、电刺激脉冲和固有心电信号等。固有心电信号可以包括由心脏产生的电信号，并且可以由心电图(ECG)表示。
电极214可包括一种或多种生物相容的导电材料，例如已知可安全植入人体内的各种金属或合金。在一些情况下，电极214通常可以设置在LCP 200的任一端上，并且可以与模块202、204、206、208和210中的一个或多个电通信。在电极214被直接固定到壳体220的实施例中，绝缘材料可以将电极214与邻近电极、壳体220和/或LCP 200的其他部分电隔离。在一些情况下，一些或所有电极214可以与壳体220间隔开并且可以通过连接线连接到壳体220和/或LCP 200的其他组件。在这种情况下，电极214可以放置在远离壳体220延伸出的尾部(未示出)上。如图10所示，在一些实施例中，LCP 200可以包括电极214'。电极214'可以是电极214的补充，或者可以代替电极214中的一个或多个。除了电极214'设置在LCP 200的侧面之外，电极214'可以类似于电极214。在一些情况下，电极214'可以增加LCP 200可以通过其递送通信信号和/或电刺激脉冲的电极的数量，和/或可以感测固有的心电信号、通信信号和/或电刺激脉冲。
电极214和/或114'可以呈现各种尺寸和/或形状中的任何一种，并且可以以各种间距中的任何一种间隔开。例如，电极214可以具有2至20毫米(mm)的外径。在其他实施例中，电极214和/或114'可以具有2、3、5、7毫米(mm)的直径，或任何其他合适的直径、尺寸和/或形状。电极214和/或214'的示例长度可以包括例如1、3、5、10毫米(mm)或任何其他合适的长度。如本文所用，长度是电极214和/或214'的尺寸，其远离壳体220的外表面延伸。在一些情况下，电极214和/或214'中的至少一些可以彼此间隔20、30、40、50毫米(mm)的距离或任何其它合适的间隔。单个设备的电极214和/或214'可以相对于彼此具有不同的大小，并且设备上的电极的间隔和/或长度可以是或可以不是均匀的。
在一些情况下，还可以提供LV电极214”。LV电极214”可以由远离壳体220延伸的LV电极支撑件256支撑。在一些情况下，LV电极支撑件256被配置为将LV电极214”放置在心室隔膜10内，并且与延伸穿过控制LV的收缩的心室隔膜10的传导通路进行电连通。在一些情况下，LV电极支撑件256可以完全延伸穿过心室隔膜10，以便将LV电极214”放置在LV内并且与心室隔膜10的LV面向侧14接触。
在所示的实施例中，通信模块202可以电耦合到电极214、214'和/或214”中的两个或更多个，并且可以被配置为将通信脉冲递送到患者的组织以与其他设备(例如传感器、编程器、其他医疗设备等)通信。这里使用的通信信号可以是任何调制信号，其通过自身或结合一个或多个其他调制信号将信息传送到另一个设备。在一些实施例中，通信信号可以限于亚阈值信号，其不会导致心脏的捕获但仍传送信息。通信信号可以被递送到位于患者身体外部或内部的另一个设备。在一些情况下，通信可以采取由各种时间量分开的不同通信脉冲的形式。在这些情况中的一些情况下，连续脉冲之间的定时可以传送信息。通信模块202可以另外被配置为感测由其他设备递送的通信信号，其他设备可以位于患者身体的外部或内部。
通信模块202可以进行通信以帮助实现一个或多个期望的功能。一些示例功能包括递送感测数据，使用通信的数据来确定例如心律失常的事件的发生，协调电刺激治疗的递送和/或其他功能。在一些情况下，LCP 200可以使用通信信号来传送原始信息、经处理的信息、消息和/或命令和/或其他数据。原始信息可以包括例如感测的电信号(例如，感测的ECG)、从耦合的传感器收集的信号等的信息。在一些实施例中，经处理的信息可以包括已使用一种或多种信号处理技术滤波的信号。经处理的信息还可以包括由LCP 200和/或另一个设备确定出的参数和/或事件，例如确定出的心率、确定出的心搏的定时、其他确定出的事件的定时、阈值交叉的确定、监视的时间周期的到期、加速计信号、活动水平参数、血氧参数、血压参数、心音参数等。在一些情况下，经处理的信息可以例如由化学传感器或光学接口传感器提供。消息和/或命令可以包括指示另一个设备采取动作的指令等、发送设备的即将发生的动作的通知、从接收设备读取的请求、向接收设备写入数据的请求、信息消息和/或其他消息命令。
在至少一些实施例中，通信模块202(或LCP 200)还可以包括开关电路，以选择性地将电极214、214'和/或214”中的一个或多个连接到通信模块202以选择通信模块202利用电极214、214'和/或214”中的哪一个递送通信脉冲。预期通信模块202可以经由传导信号、射频(RF)信号、光学信号、声学信号、电感耦合和/或任何其他合适的通信方法与其他设备通信。在通信模块202产生电通信信号的情况下，通信模块202可以包括一个或多个电容器元件和/或其他电荷存储设备，以帮助产生和递送通信信号。在所示实施例中，通信模块202可以使用存储在能量存储模块212中的能量来产生通信信号。在至少一些示例中，通信模块202可以包括连接到能量存储模块212的开关电路，并且利用开关电路，可以将能量存储模块212连接到电极214/214'/214”中的一个或多个以产生通信信号。
如图10所示，脉冲发生器模块204可以电连接到电极214、214'和/或214”中的一个或多个。脉冲发生器模块204可以被配置为产生电刺激脉冲并经由电极214、214'和/或214”中的一个或多个将电刺激脉冲递送到患者的组织，以便实现一种或多种电刺激治疗。本文使用的电刺激脉冲意在包括可以递送到患者组织以用于治疗任何类型的疾病或异常的任何电信号。例如，当用于治疗心脏病时，脉冲发生器模块204可以产生电刺激起搏脉冲以用于捕获患者的心脏，即响应于所递送的电刺激脉冲使心脏收缩。在这些情况中的一些情况下，LCP 200可以改变脉冲发生器模块204产生电刺激脉冲的速率，例如在心律自适应起搏中。在其他实施例中，电刺激脉冲可以包括除颤/心脏复律脉冲以用于使心脏震动而免受纤维性颤动或者进入正常心律。在其他实施例中，电刺激脉冲可包括抗心动过速起搏(ATP)脉冲。应该理解，这些只是一些示例。脉冲发生器模块204可包括一个或多个电容器元件和/或其他电荷存储设备，以帮助产生和递送适当的电刺激脉冲。在至少一些实施例中，脉冲发生器模块204可以使用存储在能量存储模块212中的能量来产生电刺激脉冲。在一些特定实施例中，脉冲发生器模块204可以包括开关电路，该开关电路连接到能量存储模块212并且可以将能量存储模块212连接到电极214/214'/214”中的一个或多个以产生电刺激脉冲。在一些情况下，脉冲发生器模块204可以使用电极214提供起搏脉冲以使心脏H的RV起搏，并且可以使用电极214”向心脏H的LV提供起搏脉冲。在一些情况下，由脉冲发生器模块204为心脏H的RV起搏而产生的起搏脉冲可以根据需要在时间上偏移，具有不同的持续时间，具有不同的幅度和/或，具有与由用于起搏心脏H的LV的脉冲发生器模块204产生的起搏脉冲不同的形状。
LCP 200还可以包括电感测模块206和机械感测模块208。电感测模块206可以被配置为感测从电极214、214'和/或214”传导到电感测模块206的固有心电信号。例如，电感测模块206可以电连接到电极214、214'和/或214”中的一个或多个，并且电感测模块206可以被配置为接收经由传感器放大器等通过电极214、214'和/或214”传导的心电信号。在一些实施例中，来自电极214和/或214'的心电信号可表示来自RV的局部信息，而来自LV电极214”的心电信号可表示来自心脏H的LV的局部信息。
机械感测模块208可以包括各种传感器，或者电连接到各种传感器，例如加速度计，包括例如两轴或三轴加速度计的多轴加速度计、包括例如两轴或三轴陀螺仪的多轴陀螺仪的陀螺仪、血压传感器、心音传感器、压电传感器、血氧传感器和/或测量心脏和/或患者的一个或多个生理参数的其他传感器。当存在时，机械感测模块208可以从传感器收集指示各种生理参数的信号。电感测模块206和机械感测模块208都可以连接到处理模块210，并且可以将表示感测的心电信号和/或生理信号的信号提供给处理模块210。尽管参照图10描述为单个的感测模块，但是在一些实施例中，电感测模块206和机械感测模块208可以组合成单个模块。在至少一些示例中，LCP 200可以仅包括电感测模块206和机械感测模块208中的一个。在一些情况下，处理模块210、电感测模块206、机械感测模块208、通信模块202、脉冲发生器模块204和/或能量存储模块的任何组合可以被认为是LCP 200的控制器。
处理模块210可以被配置为指导LCP 200的操作，并且在一些实施例中，可以称为控制器。例如，处理模块210可以被配置为从电感测模块206接收心电信号和/或从机械感测模块208接收生理信号。基于接收到的信号，处理模块210可以确定例如心律失常的发生和类型和例如LCP 200是否已经去除的其他确定。处理模块210还可以从通信模块202接收信息。在一些实施例中，处理模块210可以另外使用这样的接收信息来确定心律失常的发生和类型和/或例如LCP 200是否已经去除的其他确定。还在一些附加的实施例中，LCP 200可以使用所接收的信息而不是从电感测模块206和/或机械感测模块208接收的信号-例如，如果所接收的信息被认为比从电感测模块206和/或机械感测模块208接收的信号更准确或者如果电感测模块206和/或机械感测模块208已被禁用或从LCP 200中省略。
在确定心律失常的发生之后，处理模块210可以控制脉冲发生器模块204以根据一种或多种电刺激治疗产生电刺激脉冲以治疗所确定的心律失常。例如，处理模块210可以控制脉冲发生器模块204以产生具有变化参数和不同序列的起搏脉冲，以实现一种或多种电刺激治疗。作为一个示例，在控制脉冲发生器模块204递送心动过缓起搏治疗时，处理模块210可以控制脉冲发生器模块204递送设计用于以规则间隔捕获患者心脏的起搏脉冲，以帮助防止患者心脏低于预定阈值。在一些情况下，可以随着患者的活动水平的增加而增加起搏速率(例如，速率自适应起搏)。例如，处理模块210可以监视患者的一个或多个生理参数，其可以指示需要增加的心率(例如，由于增加的代谢需求)。然后，处理模块210可以增加脉冲发生器模块204产生电刺激脉冲的速率。基于一个或多个生理参数调节电刺激脉冲的递送速率可以通过仅在生理参数指示需要增加的心脏输出时需要更高的电刺激脉冲递送速率来延长LCP 200的电池寿命。另外，通过更紧密地匹配电刺激脉冲的递送速率与患者的心脏输出需求，调节电刺激脉冲的递送速率可以增加患者的舒适水平。
对于ATP治疗，处理模块210可以控制脉冲发生器模块204以比患者的固有心率更快的速率传递起搏脉冲，以试图迫使心脏响应于所递送的起搏脉冲而不是响应于固有心电信号而搏动。一旦心脏跟随起搏脉冲，处理模块210就可以控制脉冲发生器模块204以将递送的起搏脉冲的速率降低到更安全的水平。在CRT中，处理模块210可以控制脉冲发生器模块204以与另一个设备协调地递送起搏脉冲，以使心脏更有效地收缩。在脉冲发生器模块204能够产生用于除颤/心脏复律治疗的除颤和/或心脏复律脉冲的情况下，处理模块210可以控制脉冲发生器模块204产生这样的除颤和/或心脏复律脉冲。在一些情况下，处理模块210可以控制脉冲发生器模块204产生电刺激脉冲，以提供与上述那些示例不同的电刺激治疗。
除了控制脉冲发生器模块204产生不同类型的电刺激脉冲并且以不同序列之外，在一些实施例中，处理模块210还可以控制脉冲发生器模块204产生具有变化脉冲参数的各种电刺激脉冲。例如，每个电刺激脉冲可以具有脉冲宽度和脉冲幅度。处理模块210可以控制脉冲发生器模块204产生具有特定脉冲宽度和脉冲幅度的各种电刺激脉冲。例如，如果电刺激脉冲没有有效地捕获心脏(例如RV或LV捕获)，则处理模块210可以使脉冲发生器模块204调节电刺激脉冲的脉冲宽度和/或脉冲幅度。对各种电刺激脉冲的特定参数的这种控制可以帮助LCP 200提供电刺激治疗的更有效的递送。
在一些实施例中，处理模块210还可以控制通信模块202向其他设备发送信息。例如，处理模块210可以控制通信模块202产生一个或多个通信信号，用于与设备系统的其他设备通信。例如，处理模块210可以控制通信模块202产生特定脉冲序列的通信信号，其中特定序列传送不同的信息。通信模块202还可以接收用于由处理模块210进行潜在动作的通信信号。
在进一步的实施例中，处理模块210可以控制开关电路，通过该开关电路通信模块202和脉冲发生器模块204将通信信号和/或电刺激脉冲递送到患者的组织。如上所述，通信模块202和脉冲发生器模块204都可以包括用于将电极214、214'和/或214”中的一个或多个连接到通信模块202和/或脉冲发生器模块204的电路，使得这些模块可以将通信信号和电刺激脉冲递送到患者的组织。通信模块202和/或脉冲发生器模块204通过其递送通信信号和电刺激脉冲的一个或多个电极的特定组合可以影响通信信号的接收和/或电刺激脉冲的有效性。尽管描述了通信模块202和脉冲发生器模块204中的每一个可以包括开关电路，但是在一些实施例中，LCP 200可以具有连接到通信模块202、脉冲发生器模块204和电极214、214'和/或214”的单个切换模块。在这样的实施例中，处理模块210可以控制切换模块以适当地连接模块202/204和电极214/214'/214”。在一些情况下，LV电极214”也可以耦合到切换模块并且可以用于通信。
在一些实施例中，处理模块210可以包括预编程芯片，例如超大规模集成(VLSI)芯片或专用集成电路(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LCP200的操作。通过使用预编程的芯片，处理模块210可以使用比其他可编程电路更少的功率，同时能够维持基本因此，从而可能潜在地LCP 200的电池寿命。在其他情况下，处理模块210可以包括可编程微处理器等。这种可编程微处理器可以允许用户在制造之后调节LCP 200的控制逻辑，从而允许LCP 200比在使用预编程芯片时更大的灵活性。还在其他实施例中，处理模块210可以不是单个组件。例如，处理模块210可以包括位于LCP 200内的不同位置处的多个组件，以便执行各种描述的功能。例如，一些功能可以在处理模块210的一个组件中执行，而其他功能在处理模块210的单独组件中执行。
在另外的实施例中，处理模块210可以包括存储器电路，并且处理模块210可以在存储器电路上存储信息和从存储器电路读取信息。在其他实施例中，LCP200可以包括与处理模块210通信的单独的存储器电路(未示出)，使得处理模块210可以向单独的存储器电路写入信息和从单独的存储器电路读取信息。存储器电路，无论是处理模块210的一部分还是与处理模块210分开，都可以是易失性存储器、非易失性存储器或易失性存储器和非易失性存储器的组合。
能量存储模块212可以向LCP 200提供电源以用于其操作。在一些实施例中，能量存储模块212可以是不可再充电的锂基电池。在其他实施例中，不可再充电的电池可以由其他合适的材料制成。在一些实施例中，能量存储模块212可以被认为是可再充电电源，例如但不限于可再充电电池。在其他实施例中，能量存储模块212可以包括其他类型的能量存储设备，例如电容器或超级电容器。在一些情况下，如将讨论的，能量存储模块212可以包括可再充电的一次电池和不可再充电的二次电池。在一些情况下，如果存在，则一次电池和二次电池都可以是可再充电的。
为了将LCP 200植入患者体内，操作者(例如，医生、临床医生等)可以将LCP 200固定到患者心脏的心脏组织。为了便于固定，LCP 200可以包括一个或多个锚216。一个或多个锚216可以包括任何数量的固定或锚固机构。例如，一个或多个锚216可以包括一个或多个销、U形钉、螺纹、螺钉、螺旋、齿等。在一些实施例中，虽然未示出，但是一个或多个锚216可以包括在其外表面上的螺纹，该螺纹可以沿着锚构件的至少一部分长度延伸。螺纹可以在心脏组织和锚之间提供摩擦力，以帮助将锚构件固定在心脏组织内。在一些情况下，一个或多个锚216可以包括锚构件，该锚构件具有可以拧入心脏组织的软木螺钉形状。在其他实施例中，锚216可以包括其他结构，例如倒钩、长钉等，以便于与周围心脏组织接合。
图11是示出用于促进双室心脏起搏的说明性方法300的流程图。在一些情况下，并且如框302所示，方法300包括将IMD(例如但不限于IMD 20、IMD50和/或IMD 90)推进到接近心脏隔膜的第一侧的位置，IMD包括壳体和相对于壳体设置的两个第一腔室电极，IMD还包括第二腔室电极和电极位置调节组件，该电极位置调节组件具有用于调节第二腔室电极相对于壳体的位置的联接器。如框304所示，调节工具可以配合到电极位置调节组件的联接器。如框306所示，可以操纵调节工具以相对于壳体移动联接器以调节第二腔室电极相对于壳体的位置。如框308所示，可以部署固定机构以相对于隔膜固定IMD。
图12是示出用于促进双腔室心脏起搏的说明性方法310的流程图。在一些情况下，并且如框302所示，方法300包括将IMD(例如但不限于IMD 20、IMD50和/或IMD 90)推进到接近心脏隔膜的第一侧的位置，IMD包括壳体和相对于壳体设置的两个第一腔室电极，IMD还包括第二腔室电极和电极位置调节组件，该电极位置调节组件具有用于调节第二腔室电极相对于壳体的位置的联接器。如框304所示，调节工具可以配合到电极位置调节组件的联接器。如框306所示，可以操纵调节工具以使联接器相对于壳体移动，以调节第二腔室电极相对于壳体的位置。
在一些情况下，并且如框312所示，方法310可以包括测试心脏的捕获。在一些情况下，IMD可能处于捕获心脏的良好位置处。在一些情况下，如框314所示，初始放置可能不会产生良好的捕获，并且IMD可以被移动到不同的位置。如框316所示，方法310可以包括再次测试以进行捕获。在一些情况下，这可以是迭代过程。一旦找到具有良好捕获的位置，并且如框308所示，可以部署固定机构以相对于隔膜固定IMD。
图13是示出用于促进双腔室心脏起搏的说明性方法318的流程图。在一些情况下，并且如框302所示，方法300包括将IMD(例如但不限于IMD 20、IMD50和/或IMD 90)推进到接近心脏隔膜的第一侧的位置，IMD包括壳体和相对于壳体设置的两个第一腔室电极，IMD还包括第二腔室电极和电极位置调节组件，该电极位置调节组件具有用于调节第二腔室电极相对于壳体的位置的联接器。如框304所示，调节工具可以配合到电极位置调节组件的联接器。如框306所示，可以操纵调节工具以使联接器相对于壳体移动，以调节第二腔室电极相对于壳体的位置。
在一些情况下，并且如框320所示，方法318可以包括测试心脏的捕获，其中第二腔室电极相对于壳体设置在第一距离处(或者，在进入隔膜的第一穿透距离处)。在一些情况下，电极可以处于用于捕获心脏的良好深度处。在一些情况下，如框322所示，初始深度可能不会产生良好的捕获，并且电极可以移动到相对于壳体的不同位置(或不同的穿透深度)。如框324所示，方法318可以包括再次测试以进行捕获。在一些情况下，这可以是迭代过程。一旦已经找到具有良好捕获的位置，并且如框308所示，可以部署固定机构以相对于隔膜固定IMD。
在一些情况下，IMD可以包括在外轴上延伸到隔膜中的多个第二腔室电极，而不是在隔膜内延伸或缩回单个电极。在这些情况下，可以测试一系列可单独寻址的电极中的每一个以进行捕获，而不是将单个电极更深地移动到隔膜中，或者从隔膜中部分地抽出单个电极。
应该理解，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，可以进行细节上的改变，特别是在形状、尺寸和步骤布置方面。在适当的程度上适当的是，这可以包括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)
1.一种可植入医疗设备(IMD)，其被配置用于部署在患者心脏的心室隔膜处，所述患者心脏的心室隔膜具有右心室(RV)面向侧和左心室(LV)面向侧，所述IMD包括：
壳体，其具有近端和远端，所述壳体被配置成至少部分地定位在患者心脏的右心室(RV)中，其中一旦所述IMD被植入在患者的心脏中，所述壳体的远端就接近所述心室隔膜的RV面向侧；
电源，其设置在所述壳体内；
电路，其设置在所述壳体内并可操作地耦合到所述电源；
第一RV电极，其邻近所述壳体的远端并且一旦所述IMD被植入就定位在面向所述心室隔膜的RV面向侧，所述第一RV电极与所述壳体中的电路可操作地耦合；
第二RV电极，其与所述第一RV电极接近地间隔开，所述第二RV电极与所述壳体中的电路可操作地耦合；
LV电极，其远离所述第一RV电极定位并且一旦所述IMD被植入就至少部分地位于所述心室隔膜中，所述LV电极与所述壳体中的电路可操作地耦合；和
LV电极位置调节组件，用于调节所述LV电极远离所述第一RV电极定位的距离，其中所述LV电极位置调节组件包括相对于所述壳体固定的联接器，其中所述联接器被配置成与单独的调节工具配合，所述单独的调节工具能够使所述联接器相对于所述壳体移动以调节所述LV电极远离所述第一RV电极定位的距离。
2.根据权利要求1所述的IMD，其中所述LV电极位置调节组件包括远离所述壳体延伸的固定螺旋件，其中所述LV电极定位在所述固定螺旋件上，所述固定螺旋件包括接近轴部分，其延伸穿过所述壳体的内腔并且在所述联接器中终止，使得旋转所述联接器使所述固定螺旋件相对于所述壳体旋转并使所述固定螺旋件自身旋入所述心室隔膜中。
3.根据权利要求1所述的IMD，其中所述LV电极位置调节组件包括：
内轴，其可操作地耦合到所述联接器；和
外轴，与所述内轴螺纹接合并且被配置成不相对于所述壳体旋转，其中所述内轴经由所述联接器的旋转导致所述外轴相对于所述壳体的平移，其中所述LV电极相对于所述外轴固定并随着所述外轴平移。
4.根据权利要求3所述的IMD，其中所述外轴的至少一部分具有横截面轮廓，所述横截面轮廓接合所述壳体的互补接合部分以防止所述外轴相对于所述壳体旋转。
5.根据权利要求1至4中任一项所述的IMD，其中，所述联接器包括耦合到所述内轴的近端的可旋转的系绳环，使得旋转所述可旋转的系绳环使所述内轴相对于所述外轴旋转，从而致使所述外轴平移以作为响应。
6.根据权利要求1至5中任一项所述的IMD，还包括弹簧触头，所述弹簧触头设置在所述壳体内并且与所述电路可操作地耦合，所述弹簧触头与所述外轴中的与所述LV电极电耦合的一部分滑动电接触。
7.根据权利要求2至6中任一项所述的IMD，还包括一个或多个固定齿，所述固定齿被配置为延伸到所述心室隔膜中并弯曲以将所述IMD相对于所述心室隔膜锚定就位。
8.根据权利要求1至7中任一项所述的IMD，其中所述电源包括电池。
9.根据权利要求1至8中任一项所述的IMD，其中所述IMD包括双腔无引线心脏起搏器(LCP)。
10.一种可植入医疗设备(IMD)，其被配置用于部署在患者心脏的心腔内、患者心脏的隔膜附近，所述患者心脏的隔膜具有面向心腔的第一腔室面向侧和第二相对腔室面向侧，所述IMD包括：
壳体，被配置成一旦所述IMD被植入患者心脏中，就至少部分地定位在接近隔膜的第一腔室面向侧的心腔中；
电源，其设置在所述壳体内；
电路，其设置在所述壳体内并可操作地耦合到所述电源；
一个或多个第一腔室电极，其相对于所述壳体固定并且一旦所述IMD被植入就定位在接近心腔的第一腔室面向侧，所述一个或多个第一腔室电极与所述壳体中的电路可操作地耦合；
由所述壳体限定的内腔；
外轴，其延伸穿过所述内腔并可相对于所述内腔平移；
第二腔室电极，其设置在所述外轴的远端处或其附近，所述第二腔室电极与设置在所述壳体内的电路可操作地耦合；和
内轴，其与所述外轴螺纹接合使得所述内轴能够相对于所述外轴旋转，以实现所述外轴相对于所述壳体的平移，所述外轴能够在所述第二腔室电极接近隔膜的第一腔室面向侧的缩回位置和所述第二腔室电极至少部分地延伸到隔膜中的延伸位置之间平移。
11.根据权利要求10所述的IMD，其中所述外轴的至少一部分具有横截面轮廓，所述横截面轮廓与所述壳体的互补接合部分接合，以防止所述外轴相对于所述壳体旋转。
12.根据权利要求10或11中任一项所述的IMD，其中所述内轴接近地延伸穿过所述内腔并且在所述联接器中终止，使得旋转所述联接器使所述内轴相对于所述外轴旋转。
13.根据权利要求10至12中任一项所述的IMD，还包括一个或多个固定齿，其被配置为延伸到所述隔膜中并弯曲以将所述IMD相对于所述隔膜锚定就位。
14.根据权利要求10至13中任一项所述的IMD，还包括弹簧触头，所述弹簧触头设置在所述壳体内并与所述电路可操作地耦合，所述弹簧触头使得与所述外轴中的与所述第二腔室电极电耦合的一部分滑动电接触。
15.根据权利要求10至14中任一项所述的IMD，其中所述IMD包括双腔无引线心脏起搏器(LCP)。
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| PCT/US2017/047378 WO2018035343A1 (en) | 2016-08-19 | 2017-08-17 | Trans septal implantable medical device |
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| CN113101522A (zh) * | 2021-04-26 | 2021-07-13 | 上海联心医疗科技有限公司 | 一种植入式心脏起搏装置 |
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| US10391319B2 (en) | 2019-08-27 |
| CN109562269B (zh) | 2023-08-11 |
| EP3500342B1 (en) | 2020-05-13 |
| US20180050208A1 (en) | 2018-02-22 |
| WO2018035343A1 (en) | 2018-02-22 |
| EP3500342A1 (en) | 2019-06-26 |
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