CN103945899B - 用于可植入医疗装置的输送系统组件 - Google Patents

用于可植入医疗装置的输送系统组件 Download PDF

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CN103945899B
CN103945899B CN201280056608.5A CN201280056608A CN103945899B CN 103945899 B CN103945899 B CN 103945899B CN 201280056608 A CN201280056608 A CN 201280056608A CN 103945899 B CN103945899 B CN 103945899B
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W·A·贝尔蒂奥姆
H·A·斯泰因吉瑟
D·H·特兰
E·格里斯沃尔德
B·L·洛钦
J·C·埃兰
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Abstract

输送系统组件的内部子组件在该组件的细长外管的内腔中延伸，并且包括扩开远端，该扩开远端较佳地构造成顺应于可植入医疗装置的近端；外管的最远侧部分的尺寸设计成包含扩开远端和整个医疗装置。内部子组件包括芯部、沿芯部延伸的细长拉线和围绕拉线和芯部的套管；该套管包括允许拉线在侧面通过它的槽开口。该组件较佳地沿套管的长度具有预形成的弯曲部，且槽开口沿预形成的弯曲部延伸。外管相对于内部子组件纵向可动，以例如部署医疗装置。

Description

用于可植入医疗装置的输送系统组件
技术领域
本发明涉及用于可植入医疗装置的输送系统组件，并且更具体地涉及构造成便于相对紧凑的可植入医疗装置的经皮经静脉部署的输送系统组件。
背景技术
典型的可植入心脏起搏器包括脉冲发生器装置，而一根或多根柔性细长引线联接于该脉冲发生器装置。该脉冲发生器装置通常相对于心脏远程地植入在皮下囊内，且一根或多根引线中的每根都从该脉冲发生器装置延伸至对应的电极、联接于该电极并定位在起搏部位处、即心内膜或心外膜处。有时与细长的引导线相关联并且对于本领域技术人员众所周知的机械复杂性和/或MRI兼容性问题促使了心脏起搏装置的发展，这些心脏起搏装置完全容纳在相对紧凑的包装内，用以紧邻于起搏位置地进行植入，例如在心脏的右心室(RV)内。参见图1，示出了此种装置100，其中，起搏/感测电极111、112形成在封壳的外表面上，该封壳气密地容纳包括脉冲发生器电子器件的脉冲发生器和电源。图1示出固定构件115，该固定构件安装于装置100封壳的位于电极111附近的端部，以抵靠于心内膜表面将电极111固定或稳固在右心室的心尖中。封壳较佳地由诸如钛之类的可生物相容和生物稳定的金属制成，除了电极112形成为封壳的露出部分的位置以外，该金属上覆盖有绝缘层、例如医疗级别的聚氨酯或硅酮。例如任何本领域技术人员已知的气密馈通组件(未示出)将电极111联接于容纳在装置100封壳内的脉冲发生器。
图1还示出标准引导导管150的远侧部分，根据介入性心脏病学领域已知的方法，将该标准引导导管向上操纵通过下腔静脉(IVC)并从右心房(RA)进入到右心室内。尽管导管150可用于将装置100输送到右心室以进行植入，但会期望更精细的输送系统，这些输送系统便于更适于如装置100的相对紧凑的可植入装置的改善的引导和部署。
发明内容
根据本发明的实施例，一种输送系统组件包括内部子组件和外部子组件，并可偏转和可收回以用于部署可植入医疗装置。内部子组件的细长芯部在外部子组件的细长外管的内腔中延伸，并且内部子组件还包括沿芯部延伸的细长拉线和套管，该套管在由外管构成的内腔内围绕拉线和芯部延伸。细长芯部较佳地包括扩开远端，该扩开远端可顺应于医疗装置的近端；且外管的最远侧部分较佳地将尺寸设计成包含芯部的扩开远端和整个医疗装置。
可致动拉线以使芯部的扩开远端连同外管的最远侧部分一起偏转，因而，外管内腔的远侧开口可指向目标植入部位，以经该远侧开口来部署所包含的医疗装置，例如是通过使外管相对于内部子组件收回。套管较佳地包括槽开口，该槽开口定位成并且尺寸设计成允许拉线在侧面通过该槽开口。根据一些较佳实施例，组件沿套管的长度具有预形成的弯曲部，以使外管的最远侧部分定向，从而在患者的静脉系统内进行引导，且槽开口沿预形成的弯曲部的长度延伸。
可通过例如经由输送系统的手柄的第一控制构件使外管向近侧方向相对于内部子组件在第一和第二位置之间运动来完成对医疗装置的部署。当外管处于第一位置时，上述偏转可例如经由手柄的第二控制构件致动；并且当外管向近侧运动时或者向第二位置收回时，医疗装置的固定构件露出，以在目标植入部位附近与组织相配合。
附图说明
下面的附图是对本发明的具体实施例的说明，且因此不限制本发明的范围。各附图不按比例(除非指出)且旨在与下面的详细描述中的解释结合使用。下面将结合附图描述各实施例，其中，相同的附图标记表示相同的元件，以及：
图1是示出所植入的心脏刺激装置的示例的示意图；
图2A是根据一些实施例的输送系统组件的平面图；
图2B-C分别是根据一些实施例的、图2A所示系统组件的内部子组件和外部子组件的平面图；
图3A是根据一些替代实施例的输送系统组件的包括剖切部段的平面图，其中，输送系统组件的外管处于第一位置；以及
图3B是图3A的组件的包括剖切部段的平面图，其中，外管处于第二位置。
具体实施方式
下面的详细描述在本质上仅仅是示例性的，但不意在以任何方式限制本发明的范围、应用或构造。相反，下文描述提供的是实践示例，且本领域技术人员会认识到其中一些示例可具有合适的替代。
图2A是根据一些实施例的输送系统组件200的平面图；以及图2B-C分别是系统组件200的内部子组件220和外部子组件240的平面图。图2A示出包括手柄210和细长外管230的系统组件，该细长外管从手柄210延伸到其远端232。根据所示实施例，外管230构成内腔(未示出)，内部子组件220于该内腔内延伸；以及应当理解到，由外管230构成的内腔较佳地具有位于近端231处的近侧开口和位于远端232处的远侧开口。图2B示出内部子组件220，该内部子组件包括细长芯部250、沿芯部250延伸的细长拉线225以及套管260，该套管例如在约12厘米到约18厘米的长度上围绕拉线225和芯部250。图2A还示出包括第一控制构件211和第二控制构件212的手柄210。参照图2C，外管230的近端231示出为例如通过紫外线固化粘合剂而联接于第一控制构件211；以及参照图2B，拉线的近端51示出为例如通过紫外线固化粘合剂而联接于第二控制构件212。根据示例性实施例，拉线225具有约0.009英寸(约0.23mm)的直径，并由医用级304不锈钢制成，该不锈钢较佳地涂覆有诸如聚四氟乙烯(PTFE)之类的含氟聚合物。根据图2B，芯部250向着近侧越过外管的近端231和第二控制构件212而延伸到其近端251，该近端较佳地固定在手柄210内，并且可联接于鲁尔(Luer)装配件(未示出)，而停止旋塞290如图2A所示联接于该鲁尔装配件。根据一些较佳实施例，控制构件211、212可沿手柄210滑动，因而：第一控制构件211致动外管的纵向运动，以相对于内部子组件220和手柄210收回外管230(图3B)；以及第二控制构件212致动拉线225，以使芯部250的扩开远端252偏转，而该扩开远端则在使外管230收回之前又使外管230的远端232(图3A)例如向着目标植入部位偏转。
芯部250的扩开远端252较佳地构造成顺应于可植入医疗装置100的近端121，例如如图3A中所示，并且进一步参照图3A，外管230的内腔沿外管230的最远侧部分235的长度，其尺寸被设计成将扩开远端252和装置100包含在一起，以将装置100输送到目标植入部位附近。根据一些实施例，在引导输送系统组件200的过程中并且在从输送系统组件部署装置100之前，远端252的顺应性构造可有助于将装置100保持在外管230的最远侧部分235内。根据示例性实施例，最远侧部分235具有约0.275英寸(约0.7cm)的内直径和大约0.3英寸(约0.8cm)的外直径。尽管图2C和3A示出了最远侧部分235例如在约3.5cm(约1.4英寸)的长度上比外管230的其余部分有所扩大，但根据替代实施例，沿外管230的更大部分的长度、甚至是整个长度的外直径都可与最远侧部分的外直径相同。根据一些较佳的实施例，芯部250的扩开远端252是不透辐射的，且外管230的远端232装有不透辐射标记，从而能经由荧光检查法来观察外管230相对于扩开远端252收回，接下来将更详细描述这种收回。根据示例实施例，扩开远端252由带有辐射不透硫酸钡填充剂的聚醚嵌段酰胺、例如7033形成；而外管230的最远侧部分235由聚醚嵌段酰胺、例如7233形成，该聚醚嵌段酰胺在远端232处包括夹在各7233各层之间的不透辐射带，该不透辐射带由75％钨和25％6033形成。
图2B和3A示出包括槽开口265的套管260，该槽开口定位成并且尺寸设计成允许拉线225在侧面穿过该槽开口。槽265的长度可在约1厘米到约5厘米之间、较佳地在约2.5厘米到约3厘米之间。图2B和3A还示出紧邻拉线225的被锚定的远端52而联接于芯部250的套管260的远端62以及向远侧与手柄210间隔开例如纵向距离y(图3A)的套管260的近端61，该纵向距离在约90厘米到约100厘米之间。
图2A-2C示出根据一些实施例的沿相对平直的线延伸的组件200，但根据一些较佳实施例，组件200具有沿套管260长度的预形成弯曲部，例如图3A中所示，其中，该长度可在约6厘米到约20厘米之间。参照图3A，预形成的弯曲部绕约9厘米到约13厘米之间的半径r延伸，并且相对于在预形成弯曲部近侧延伸的组件200的长度以约120度的角度θ来定向最远侧部分235。曲率半径r和角度θ可便于在患者静脉系统内引导输送系统组件200，例如通过定向外管230的最远侧部分235，以从RA穿过三尖瓣进入RV(图1)。进一步参照图3A，拉线225示出为在侧面延伸通过槽开口265。根据所示实施例，当第二控制构件212根据箭头P运动时，致动拉线225，以使芯部250的远端252连同外管230的远端232一起沿着箭头D偏转到例如更小的曲率半径，以使外管230的内腔的远侧开口可指向目标植入部分，以以经该远侧开口来部署所包含的医疗装置100，例如是通过如下所述相对于内部子组件200收回外管230。
根据示例性实施例，芯部250在约118厘米的长度上从近端251延伸到恰好在扩开远端252近侧，具有约0.112英寸(～2.85mm)的外直径，并且由围绕聚醚嵌段酰胺7033衬里的不锈钢编织物(0.0012”x0.003”x70PPI)制成，该衬里沿近侧部段(具有约108厘米的长度)叠置有一层聚酰胺并且沿远侧部段(具有约10厘米的长度)叠置有一层聚酰胺。在该示例性实施例中，套管260由聚醚嵌段酰胺5533制成，该套管在肖氏D级别上的硬度为约50到约55。尽管图2B示出未被约束地与芯部250并排地、从套管260向近侧延伸到近端51的一段拉线225，但根据一些替代实施例，具有约0.015英寸(约0.38mm)直径的内腔沿芯部250的壁延伸，以包含该段长度的拉线225。图2B和3A示出例如通过热粘合到构成套管260和扩开远端252之间的交汇部的聚合物熔融物内来在扩开远端252附近锚定到芯部250的拉线225的远端52。尽管未示出，拉线225的远端52可止于热粘合到套管260和扩开远端252之间的交汇部内或紧邻该交汇部的环或带。对于组件200具有预形成弯曲部的这些实施例，根据对于导管构造领域的技术人员来说已知的方法，弯曲部可通过热固来形成。在将子组件220插入外管230的内腔内之前，弯曲部可预形成到内部子组件220内，或者在将内部子组件220组装到外管内之前，弯曲部可预形成到外管230内。
外管230的构造可以是本领域中已知的任何合适类型，以实现响应于例如如上所述芯部250的偏转而适应偏转的分级柔性，并且实现为便于将输送系统组件200操纵到目标植入部位所需的可推动性和扭矩传递，如下面将更详细所述。根据示例实施例，外管230包括编织加强衬里、例如带有不锈钢编织物(即，0.0018”×0.008”×45PPI)的6333，该不锈钢编织物从近端231延伸至刚好在外管230的最远侧部分235附近；轴的近侧段覆盖有7033，并且延伸约92cm的长度(该长度的近侧部总是包含在手柄210内)；轴的中间段覆盖有4033，且在约10厘米的长度上从近侧段朝远侧延伸；而轴的远侧段覆盖有3533，并且在约3厘米的长度上从中间段朝远侧延伸至刚好在最远侧部分附近。外管230沿上述各段的外直径和内直径可以分别是大约0.187英寸(约4.75mm)和大约0.154英寸(约3.91mm)。
进一步参照图3A，当输送系统组件200在患者静脉系统内前进并被操纵到目标植入部位附近，例如在RV(图1)内时，并且当第二控制构件212根据箭头P运动，以经由拉线225致动根据箭头D的偏转时，外管230相对于芯部250大致保持在第一位置31，因而，整个装置100包含在最远侧部分235内。根据一些较佳实施例，当外管230处于第一位置31时，手柄210与外管230的远端231之间的纵向距离在例如约103厘米到约107厘米之间，以从股动脉通入部位到达RV。一旦偏转以使外管230的远端232与目标植入部位相邻，第一控制构件211根据箭头M如图3B中所示地运动，以使外管230相对于芯部250纵向地从第一位置31根据箭头R收回到第二位置32。根据所示实施例，外管230的收回使装置100的固定构件115露出，该固定构件在最外侧部分235外穿过外管230的内腔的远侧开口，以在目标植入部位处接合到组织内。根据一些实施例，例如可由硅酮油润滑的O形环类型的密封构件(即，硅酮；未示出)在第一控制构件211附近、在手柄210内的外管230和芯部250之间形成动态密封交界部。
扩开远端252的上述顺应性构造可有助于保持装置100和输送系统组件200之间的临时连接，直至固定构件115变得与组织接合；但根据一些较佳实施例，装置100还通过系绳固定到系统组件200，该系绳可移除地附连到装置100的近端121，例如如上引用的相关美国专利申请序列号13/279,835(代理案卷号P0040169.USU1)中所述那样。上述引用的相关申请中的另一个，即美国申请序列号13/219,279(代理案卷号P0041227.USU1)描述了可用于系绳附连的装置100近端121的一些替代构造。尽管图3A示出与芯部250的扩开远端252大致对准的外管230远端232，但当外管230处于第二位置32时，第二位置32可位于更近侧，因而，更多芯部250在外管230的远端232远侧或者更远侧露出，因而，仅装置100的固定构件115露出。根据图3B，当外管230处于第二位置32时，整个装置100露出；因此，根据装置100的长度，第一位置31和第二位置32之间的纵向距离可小到约2cm直至约6cm。替代地，第二位置32如上所述可定位成仅露出装置100的一部分、例如固定构件115就足够了，以将装置100稳固在植入部位处，在该情形下，第一和第二位置之间的纵向距离可以小到约0.5cm至1cm。
进一步参见图2A，输送系统组件200在手柄210附近还包括可选的覆盖件，该覆盖件如所示围绕外管230。可选的覆盖件275在系统组件200和用于将系统组件200引入患者静脉系统内的引入器套管的阀之间提供增强的交界部，以便于外管230相对于芯部250和手柄210的上述纵向运动。例如，增强的交界部提供改善的密封性，和/或提供附加的径向强度，以对抗阀的压缩力，如果阀是Toughy Borst型的，则根据操作者不同，该阀能在系统组件200周围拧紧至不同的程度。可选的覆盖件275较佳地可在外管230上滑动，以使覆盖件275可相对于手柄210重新定位，以与引入器套管的阀重合。根据示例性实施例，可选的覆盖件275由聚醚嵌段酰胺、例如7030制成，该聚醚嵌段酰胺可包括二氧化钛填充物。这种覆盖件在上述相关美国专利申请序列号13/239,990中描述(代理案卷号P0040842.USU1)，该申请的内容以参见的方式纳入本文。应注意到，尽管未示出，输送系统组件200可替代地或附加地包括像稳定套管(250)的外稳定套管，该外稳定套管就在上述相关申请中描述，该申请以参见的方式纳入本文。
前述的详细描述中，已经参考具体实施例描述了本发明。但是，可理解的是在不背离所附权利要求书所阐述的本发明的范围的情况下，可进行各种修改和改变。

Claims (15)

1.一种便于部署可植入医疗装置的输送系统组件，所述输送系统组件包括：
手柄，所述手柄包括第一控制构件和第二控制构件；
细长的芯部，所述芯部从其近端延伸到其扩开远端，所述近端固定到所述手柄内，且所述扩开远端构造成顺应于所述医疗装置的近端；
细长的外管，所述外管形成内腔，所述芯部在所述内腔中延伸，所述外管包括近端、远端和从所述外管的所述远端向近侧延伸的最远侧部分，所述内腔具有位于所述外管的所述近端处的近侧开口和位于所述外管的所述远端处的远侧开口，所述外管的所述近端联接于所述手柄的所述第一控制构件，借助所述第一控制构件，所述外管相对于所述手柄和所述芯部在第一位置和第二位置之间纵向运动，当所述外管处于第一位置时，所述芯部的所述扩开远端位于所述最远侧部分内，且所述外管的所述内腔沿所述最远侧部分的长度而将尺寸设计成，当所述外管处于第一位置时，将所述芯部的所述扩开远端和整个医疗装置一起包含到所述最远侧部分内；
细长的拉线，所述拉线沿所述芯部并且在所述外管的所述内腔中延伸，所述拉线包括近端和远端，所述拉线的所述近端联接于所述手柄的所述第二控制构件，而所述拉线的所述远端紧邻所述扩开远端而锚定到所述芯部；以及
套管，所述套管在所述拉线和所述芯部周围并且在所述外管的内腔中延伸，所述套管包括远端、近端和位于它们之间的槽开口，所述套管的所述远端紧邻所述拉线的被锚定的所述远端而联接于所述芯部，所述套管的所述近端位于所述外管的内腔内，并向着远侧而与所述手柄间隔开，且所述槽开口定位成和尺寸设计成允许所述拉线在侧面通过所述槽开口；
其中，当所述外管处于第二位置时，所述芯部的所述扩开远端在所述外管的所述远端附近。
2.如权利要求1所述的组件，其特征在于，所述套管的所述槽开口的长度为2.5厘米到3厘米之间。
3.如权利要求1所述的组件，其特征在于，所述套管具有12厘米到18厘米之间的长度，且所述套管的所述近端向着远侧而与所述手柄间隔开90厘米到100厘米之间的纵向距离。
4.如权利要求1所述的组件，其特征在于，所述细长芯部由包括聚醚嵌段酰胺和聚酰胺的编织增强型聚合物制成；以及，所述套管由在肖氏D级别上硬度为50到55的聚醚嵌段酰胺制成。
5.如权利要求1所述的组件，其特征在于，所述组件具有沿所述套管的长度的预形成弯曲部，所述弯曲部绕9厘米到13厘米之间的半径延伸，并且所述套管的槽开口沿所述弯曲部的长度延伸。
6.如权利要求1所述的组件，其特征在于，所述芯部的所述扩开远端是不透辐射的。
7.如权利要求1所述的组件，其特征在于，在所述外管位于第一位置时，所述手柄与所述外管的所述远端之间的纵向距离为103厘米到107厘米之间。
8.如权利要求1所述的组件，其特征在于，所述外管的所述第一位置和所述第二位置之间的纵向距离在从2厘米到6厘米的范围中。
9.如权利要求1所述的组件，其特征在于，还包括在所述手柄附近围绕所述外管的阀交界覆盖件，所述覆盖件能在所述外管上滑动，以相对于所述手柄重新定位所述覆盖件。
10.一种便于部署可植入医疗装置的输送系统组件，所述输送系统组件包括：
细长的外管，所述外管从其近端延伸到其最远侧部分，所述外管形成内腔，所述内腔从其位于所述外管的所述近端处的近侧开口延伸到其使所述外管的所述最远侧部分终止的远侧开口，所述最远侧部分的尺寸设计成将整个可植入医疗装置包含在内；
在由所述外管构成的所述内腔中延伸的内部子组件，所述内部子组件包括细长芯部、拉线和在所述拉线和所述芯部周围延伸的套管，所述芯部包括近端和扩开远端，所述芯部的所述近端定位在所述外管的所述近端附近，所述扩开远端构造成顺应于所述医疗装置的近端，以使所述芯部的所述远端连同整个所述医疗装置一起装入所述外管的最远侧部分内，所述拉线沿所述芯部延伸并且包括紧邻其所述扩开远端而锚定到所述芯部的远端，所述套管从其近端延伸到其远端，所述套管的所述近端向着远侧与所述外管的所述近端间隔开，且所述远端紧邻所述拉线的被锚定的远端而联接于所述芯部，所述套管包括形成于其内的槽开口，且所述槽开口的尺寸设计成允许所述拉线在侧面通过所述槽开口；
其中，所述组件沿所述套管的长度具有预形成的弯曲部，且所述套管的所述槽开口沿预形成的所述弯曲部延伸；以及
所述外管相对于所述内部子组件纵向可动。
11.如权利要求10所述的组件，其特征在于，预形成的所述弯曲部绕9厘米到13厘米之间的半径延伸，并且所述外管的最远侧部分通过所述弯曲部相对于在预形成的所述弯曲部近侧延伸的所述组件的长度以120度定向。
12.如权利要求10所述的组件，其特征在于，所述内部子组件的所述套管的所述槽开口的长度为2.5厘米到3厘米之间。
13.如权利要求10所述的组件，其特征在于，所述内部子组件的套管具有12厘米到18厘米之间的长度，且所述套管的近端向远侧与所述外管的所述近端间隔开90厘米到100厘米之间的纵向距离。
14.如权利要求10所述的组件，其特征在于，所述内部子组件的所述细长芯部由包括聚醚嵌段酰胺和聚酰胺的编织增强型聚合物制成；所述套管由在肖氏D级别上的硬度为50到55的聚醚嵌段酰胺制成。
15.如权利要求10所述的组件，其特征在于，所述内部子组件的所述芯部的所述扩开远端是不透辐射的。
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US9216293B2 (en) 2015-12-22
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