CN102573665B - 用于柔性组织紧固件的递送装置和方法 - Google Patents
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Abstract
本发明涉及用于封闭左心耳或其它组织结构的基部的装置、系统和方法，其包括具有夹钳、杆和手柄的装置施加器。在手柄上的第一扳机和第二扳机构能够以步进的方式闭合夹钳和封闭装置，其中在封闭装置内的组织穿透紧固件通过在夹钳上的螺柱接合，其中螺柱必须在打开夹钳之前被释放。
Description
技术领域
本发明整体涉及医疗器械、系统和方法。更具体地，本发明涉及用于递送柔性紧固件的工具、系统和方法，以及用于组织修复的挤压结构，以例如在其基部附近隔离左心耳和其它组织结构。
背景技术
心房颤动是相对常见的疾病，其特征在于左心房和右心房十分快速的心搏。虽然心房颤动自身通常不会致死，但其与增加中风的危险有关。确信的是，快速心搏导致血液积聚在左心耳中，这会导致栓塞脱落进入左心房，所述栓塞可以从左心房进入脑血管，由此导致中风。除了中风之外，栓塞可以进入冠脉循环，可能导致心肌梗死，或者可以进入外周循环，可能导致周围性血管疾病。
能够以多种方式降低患有心房颤动的患者中风的危险。例如，可以使用血液稀释药物来降低形成血栓的危险。然而，使用血液稀释剂使得患者不利地处于出血性疾病的危险下。
提出了更积极的治疗方案，其包括封闭左心耳。可以在开放式外科手术中执行封闭和切除，通常需要为患者置放搭桥并且通过胸骨将胸腔打开。代替地，提出了胸腔镜和其它侵害性更小的手术。美国专利No.5,306,234教示了利用其它传统的外科技术执行心脏不停跳手术。可能难以实现在心跳的同时通过很小的胸腔穿透部来使用传统技术。美国专利No.5,865,791描述了一种血管内的方法，其中工具被导引穿过脉管并穿入左心房中。所述工具用于利用能量、粘合剂等从内部消融或融合左心耳。专利′791还描述了一种胸腔镜手术，其中系链被置放在心耳的颈部上并打结以实现隔离。专利′791还提出了其它的封闭元件，包括多种缝线、钉、形状记忆丝线、生物相容性粘合剂等。美国专利No.6,488,689描述了一种胸腔镜手术，其中左心耳的远端被抓住并向后推动穿过捕获环，该捕获环包围左心耳的基部。
对于本发明特别感兴趣的是，在共同拥有的、共同审理中的美国专利公开文献2007/0260278(申请号No.11/744,135)中描述的用于密封左心耳的柔性封闭装置，其全部公开内容已在前通过引用合并在本申请中。在公开文献′135中描述的柔性结构包括具有一对相对的腿部的弹性体，所述腿部可以设置成椭圆形或U形构造以在它们之间限定开口。通过将腿部之间的开口置放在左心耳之上并使其与心耳的基部对齐，所述结构可以被闭合以实现期望的密封。为了保持结构闭合，沿各个腿部的长度设有多个分散的、轴向间隔开的组织穿透紧固件。通过将腿部一起挤压以使紧固件压配合，柔性结构可以被闭合以实现柔性的密封，这有效地隔离了左心耳。
美国专利公开文献2007/0260278描述了一种特殊的用于柔性封闭装置的递送工具。递送工具包括夹钳，所述夹钳可以插入封闭结构的腿部中并被致动以闭合在左心耳之上的腿部中的夹钳。夹钳还包括梳状螺柱，所述梳状螺柱与紧固件接合并使紧固件压配合以保持柔性结构处于其闭合、密封的构造。螺柱易于缩回以使得递送工具可以被移除。
虽然实用，但公开文献′135的递送工具具有一些缺陷。例如，夹钳的致动和梳状螺柱的缩回可能不正常地执行，从而增加了柔性结构递送失败的危险。此外，递送工具的定位和定向可能很难，特别是在工具被导引穿过脉间穿透部以到达左心房时。此外，在公开文献′278的装置中的夹钳附接在装置杆的轴向平面中。这种附接的直线方式可能使得更加难以将夹钳与心耳的基部对齐并跨越通入心耳的心房的腔。如果封闭装置没有以跨越基部的方式对齐来完全封闭所述腔，则在封闭的位置可能残留间隙或开口(称为“盲管”(cul-de-sacs))，增加了在心房中形成血栓的危险。在Salzberg等人所著的(2008)Eur.J.CardiothoracicSurg.34：766-770中讨论了形成没有这种盲管的腔的完全密封的重要性。
出于这些原因，期望提供用于与在美国专利公开文献2007/0260278中描述的组织封闭装置一起使用的改进的递送工具。还期望的是，递送工具和它们的使用方法与其它组织封闭装置兼容并用于除了封闭左心耳之外的手术。通过以下描述的发明实现至少部分这些目的。
背景技术说明：在美国专利No.6,488,689、5,865,791和5,306,234，公开的申请文件No.2005/0154404和2004/0030335中描述了用于封闭左心耳的侵害性更小的其它手术。在美国专利No.6,790,172、6,436,108、6,325,810、6,273,897、6,051,003、5,964,774、5,624,453、5,507,797和4,257,419中描述了其它组织结扎工具和相关的装置及技术。此外，参见上述的美国专利公开文献2007/0260278。
发明内容
本发明提供一种用于与封闭装置一起使用的封闭装置施加器，该封闭装置包括挤压体和多个组织穿透紧固件，所述挤压体具有两个带有相对的组织接合表面的腿部，所述组织穿透紧固件可部署在所述表面之间。在共同拥有的、共同审理中的美国专利公开文献2007/0260278中描述了这种挤压体，其全部公开内容已在前通过引用合并在本申请中。然而，本发明的施加器也可以与具有相似结构的其它封闭装置一起使用。
本发明的封闭装置施加器包括：杆；附接至杆的近端部的手柄；以及可枢转地附接至杆的远端部的一对夹钳。各个夹钳具有多个可缩回的螺柱，其中夹钳适于通过螺柱可移除地接合并保持组织封闭装置的腿部，所述螺柱接合封闭装置中的各个紧固件。手柄包括第一扳机和第二扳机。通常形成杆的联接组件将手柄与夹钳联接，其中第一扳机和第二扳机朝向手柄相继缩回以闭合夹钳并同时将螺柱接合到紧固件上以部署所述紧固件。第二扳机可以随后相对于第一扳机缩回以使螺柱从紧固件脱离，并且第一扳机和第二扳机相继运动远离手柄以打开夹钳。当夹钳完全闭合(通过以下将描述的“卡锁件”)和夹钳被锁固以防止螺柱已缩回之前的意外打开时，给出声学的确认。
如上所述设置分开的扳机是有利的，因为其使得夹钳的闭合和打开可以与螺柱缩回无关。特别地，通过如上所述地设置互锁件，封闭装置施加器可以构造成按顺序提供：(1)闭合夹钳的同时部署紧固件，(2)螺柱缩回，以及(3)打开夹钳。需要注意的是，在部署紧固件之前缩回螺柱或者在紧固件缩回之前打开夹钳会导致很大的手术失误的危险。步骤的特定的顺序通过联接组件的具体构造和包含互锁件及当装置适当地部署时的声学反馈提供。
在具体的示例中，联接组件包括沿固定的杆配置的一对套筒，它们共同限定将扳机与夹钳和螺柱联接的杆。套筒通常是同轴的，并且第一扳机连接成使第一套筒运动以闭合夹钳，而第二扳机连接至第二套筒以使螺柱脱离接合。通常，第一扳机可枢转地装配在手柄上，而第二扳机可枢转地装配在第一扳机上。
在另一具体实施例中，第一扳机通过第一连杆与第一套筒联接，而第二扳机通过第二连杆与第二套筒联接。优选地，在第一扳机与手柄之间设置有互锁件，使得当第一扳机和第二扳机相继缩回以闭合夹钳时所述互锁件被接合，而在第二扳机相对于第一扳机缩回以缩回螺柱时所述互锁件被释放。互锁件防止了夹钳在螺柱通过第二扳机缩回之前的意外打开。
在本发明的第二方案中，用于在左心耳之上闭合挤压体的封闭装置包括：杆；可枢转地连接至杆的远端部的一对夹钳；附接至杆的近端部的手柄；以及在手柄上的触发机构，该触发机构与夹钳联接以闭合夹钳并在左心耳之上部署挤压体。为了有助于夹钳上所携带的挤压体经由脉间穿透至左心耳的导引，夹钳构造成在相对于杆的轴线成10°至20°(通常为15°)的范围的角度设置的平面中打开和闭合。所述角度使得杆能够以相对于患者身体的前后面相应的角度被导引，其中所述前后面垂直于径向面。由本发明人的发现实现了对下述情况的改进，当利用在前述共同审理中的申请文献2007/0260278中公开的设计时，在轴向对齐的平面中定向的夹钳的部署难以在脉间递送方案中定位。特别是，弯曲的夹钳使得封闭构件可以横跨在左心耳的基部上对齐，使得在左心房的壁(wal)中的腔可以被完全封闭成没有盲管。
在本发明的又一个方案中，系统包括封闭装置，例如在共同拥有的、共同审理中的美国文献2007/0260278所描述的封闭装置，以及任意的上述装置施加器。
根据本发明的用于封闭组织结构的方法包括，用接合组织结构的相对侧的至少两个柔性组织接合面将挤压体定位在诸如左心耳的组织结构上。拉动与保持挤压体的一对夹钳联接的第一扳机以闭合夹钳并将多个紧固件部署在组织接合面之间并穿过所述组织结构。随后，拉动第二扳机以使在夹钳上的多个螺柱脱离与紧固件的接触，并且释放第一扳机以打开夹钳并释放挤压体。优选地，至少第一扳机和第二扳机可以选择性地互锁以防止夹钳打开，直至螺柱已经被释放。
根据本发明的用于封闭左心耳基部的方法包括，将杆穿过肋间切口朝向左心耳插入。将携带挤压体的夹钳定位在左心耳之上，其中夹钳能在相对于杆的轴线成10°至20°(通常为15°)的范围的角度设置的平面中致动。随后，闭合夹钳以将挤压体部署在左心耳之上。弯曲的夹钳的优点如上所述。
附图说明
图1为根据本发明的原理构造的封闭装置施加器的立体图。
图2为图1的封闭装置施加器的局部剖视图，示出了打开并且相对于图1所示位置旋转90°的夹钳。
图3为类似于图2的封闭装置施加器的局部剖视图，示出了第一连杆和第二连杆相对于手柄闭合以闭合夹钳。
图4为类似于图2、图3所示的封闭装置施加器的局部剖视图，示出了第二扳机相对于第一扳机闭合以使紧固件接合螺柱缩回。
图5为图2-图4所示的封闭装置施加器的局部剖视图，示出了第一扳机和第二扳机再次打开以在紧固件接合螺柱保持缩回的同时打开夹钳。
图6A-图6D示出了夹钳的动作和螺柱与组织封闭装置的紧固件的接合。
图7示出了用于使紧固件接合螺柱缩回夹钳内的机理。
图8示出了根据本发明的原理使用本发明的封闭装置施加器来在左心耳之上闭合封闭装置。
具体实施方式
本发明提供用于在因从左心耳脱落进入循环系统中的栓塞导致的中风或其它不利情况的风险下、在患者的组织结构之上部署封闭装置的替代的且改进的装置、系统和方法，所述组织结构例如为患者的左心耳。能从本发明的手术中得到益处的患者包括患有心颤的患者，心颤可能导致在左心耳中形成凝血和血栓，因此增加栓塞脱落的几率。
本发明提供一种封闭装置施加器，其用于在组织结构的基部上导引封闭装置并留在适当位置以在基部上闭合组织结构。随后，组织结构的位于基部上的部分可以被切除或以其它方式移除，当然这可以留给医师来选择。组织封闭装置包括挤压体，该挤压体具有至少两个相对的、柔性的组织接合面，该组织接合面应放置在组织结构的相对侧上。组织接合面通过多个轴向间隔开的组织穿透紧固件被保持在一起，所述组织穿透紧固件从一个表面穿过中间组织延伸到另一表面内以将挤压体保持在适当位置并施加期望水平的挤压力，该挤压力由挤压体的软度和在所述表面完全附接时所述表面之间的距离共同确定。在挤压体中围绕紧固件的组织穿透钩设置有井，使得通过挤压体在组织的穿刺位置周围形成垫片密封件。在挤压体的一个腿部中可以设有稳定唇部以防止挤压体的一个腿部相对于另一腿部的滚动运动，这保持两个相对的软构件线性对齐。封闭装置的更详细的描述参见共同拥有的、共同审理中的US2007/0260278，其全部公开内容已在前通过引用合并在本申请中。
现在参照图1，根据本发明的原理构造的封闭装置施加器10包括杆组件12，该杆组件在其近端部具有手柄组件14并且在远端部具有夹钳组件16，在该远端部处单独的夹钳18和20适于携带封闭装置22，如图6A-图6D最佳示出的。封闭装置22具有U形构造，这限定了用于在夹钳如图1、图2和图6A所示地打开时容纳左心耳或其它组织结构的V形区域24。如图6A中最佳示出的，沿各个夹钳20和18的内表面形成有多个螺柱16以与组织穿透紧固件接合，该组织穿透紧固件包括穿透部件28和接收部件30，如图6A中最佳地所示。手柄组件14包括手柄32、第一扳机34和第二扳机36。
现在参照图2和图6A，封闭装置施加器10示出了在其支架或递送构造中具有容纳在装置中的夹钳组件16和V形开口24之上的、准备置放在左心耳(见图8)或其它组织结构之上的封闭装置22。第一扳机34和第二扳机36完全打开，即完全远离手柄32地枢转。
在封闭装置22已经在左心耳或其它目标组织结构之上推进之后，夹钳18和20通过手动朝向手柄21拉动第一扳机34而被闭合，如图3和图6B所示。扳机34装配在枢轴40上，该枢轴不动地固定至手柄组件14。闭合扳机34，即在枢轴40上枢转，向近侧缩回通过销钉41和连杆43与扳机连接的杆件42。杆件42附接至销钉44(图6B)，该销钉44可枢转地附接至夹钳18和20的近端部并且向近侧缩回所述夹钳，使得所述夹钳通过槽46在附接至固定套筒52的端部框架50中的销钉48上的运动而被闭合。当夹钳18和20被闭合时，螺柱26与组织穿透部件28和组织穿透接收部件30接合，使得他们彼此接合且锁固，由此闭合了封闭装置22的两个腿部，如图6B所示。第二扳机36装配在销钉41上，使得其与第一扳机34相继地闭合。
随着第一扳机34和第二扳机36相继地闭合，具有棘轮齿表面62的互锁件60相对于销钉64闭合，如图3所示，使得一旦夹钳已经闭合扳机34就不能打开。这如上所述是有利的，因为夹钳不应该在通过闭合第二扳机36以缩回螺柱26之前被打开，以下将进行说明。
此外，随着第一扳机34被闭合以闭合夹钳组件16的夹钳18和20，互锁件60的角部66(图7)与卡锁销钉70上的斜面68接合以将卡锁销钉从保持销钉72脱离，由此使得弹簧74可以向下推动销钉70从而底面76撞击手柄的底部，由此产生响亮的咔哒声以声学地提醒医师夹钳已经闭合并且互锁件已经接合。这种声学的确认为医师指示了：封闭装置22已经闭合并且螺柱26可以缩回。
现在参照图4和图6C，螺柱26通过相对于第一扳机34闭合第二扳机36而被缩回，如图4所示。第二扳机34的闭合将在固定套筒52上的外套筒54向近侧拉动，这向近侧拉动了丝线80以向近侧推动螺柱梳84，如图7所示。螺柱梳84装配在销钉86上，该销钉于在各个夹钳18和20中形成的槽88中行进。第二扳机36通过销钉41可枢转地装配在第一扳机上并且通过销钉90和91及连杆92联接至固定套筒。
第二扳机36的闭合通过使附接至互锁件的斜面94接合靠在第二扳机中的固定销钉96上而脱离互锁件60。销钉96遵循图3中的虚线所示的路径以与面94接合。使得斜面94向下移动，推动棘轮齿62远离固定销钉64，如图4和图5所示。扳机34和36此时准备被打开以打开夹钳，如以下将要进行说明的。
现在参照图5和图7C，夹钳18和20可以通过释放在第一扳机34和第二扳机36上的手动压力而被打开，使得在第一扳机34闭合期间被压缩的弹簧98可以向远侧向前推动(附接至枢轴44的)杆件42，打开夹钳并将封闭装置22留在适当的位置。
现在参照图8，在开胸的心脏不停跳手术中，本发明的封闭装置施加器可以用于在左心耳LAA的基部之上递送封闭装置22。胸骨S被打开，肋骨R展开以提供在心脏上的工作空间。在打开心包膜之后，例如利用置放在心脏后方的一片纱布或其它材料，心脏可以被提起并转向，以在图8所示的开口中露出左心耳。在左心耳LAA露出之后，封闭装置施加器的夹钳18和20通过操作杆12被置放在心耳基部周围，如图8所示。夹钳18和20相对于杆的角度(通常约为15°)是十分有利的，因为其使得夹钳可以与左心耳的基部接合，从而它们可以大致与心耳与左心房之间的腔平行。如果夹钳的平面与杆对齐，则难以实现这种定向并且大幅增加封闭心耳且留下盲管(在所述腔上方并且在左心耳内部的开放空间)的风险。这种盲管会带来麻烦，因为它可能是凝块的来源并且如果产生必须在同一程序或随后的程序中被闭合。一旦夹钳18和20将封闭装置22适当地定位在左心耳基部的周围，夹钳被致动并且如前述地部署封闭装置。
虽然医生对本发明的优选实施例进行了说明，但可以使用多种代替方案、变型方案和等同方案。因此，以上说明并非用于对由所附权利要求书限定的本发明的范围进行限制。
Claims (16)
1.一种用于与封闭装置一起使用的封闭装置施加器，所述封闭装置包括挤压体和多个组织穿透紧固件，所述挤压体具有两个带有相对的组织接合表面的腿部，所述组织穿透紧固件能部署在所述表面之间，所述施加器包括：
杆；
手柄，所述手柄附接至所述杆的近端部并且具有第一扳机和第二扳机；
一对夹钳，所述夹钳能枢转地附接至所述杆的远端部，各个夹钳具有多个能缩回的螺柱，其中所述夹钳能够通过所述螺柱能移除地保持所述封闭装置，所述螺柱接合所述封闭装置中的所述紧固件；以及
联接组件，所述联接组件将所述手柄与所述夹钳对联接，其中所述第一扳机和第二扳机朝向所述手柄相继缩回以闭合所述夹钳并部署所述紧固件，所述第二扳机相对于所述第一扳机缩回以使所述螺柱从所述紧固件脱离，所述第一扳机和第二扳机相继运动远离所述手柄以打开所述夹钳。
2.按照权利要求1所述的施加器，其中所述联接组件包括沿所述杆配置且将所述第一扳机联接至所述夹钳以及将所述第二扳机联接至所述螺柱的一对套筒。
3.按照权利要求2所述的施加器，其中所述套筒是同轴的。
4.按照权利要求3所述的施加器，其中所述第一扳机连接至第一套筒，以闭合所述夹钳，而所述第二扳机连接至第二套筒以使所述螺柱脱离接合。
5.按照权利要求4所述的施加器，其中所述第一扳机能枢转地装配在所述手柄上。
6.按照权利要求5所述的施加器，其中所述第二扳机能枢转地装配在所述第一扳机上。
7.按照权利要求6所述的施加器，还包括连接在所述第一扳机与所述第一套筒之间的第一连杆和连接在所述第二扳机与所述第二套筒之间的第二连杆。
8.按照权利要求1至7中任一项所述的施加器，还包括位于所述第一扳机与所述手柄之间的互锁件，其中当所述第一扳机和所述第二扳机相继缩回时所述互锁件被接合，而在所述第二扳机相对于所述第一扳机缩回时所述互锁件被释放。
9.按照权利要求1至7中任一项所述的施加器，其中所述夹钳在相对于所述杆的轴线成10°至20°的范围的角度设置的平面中打开和闭合。
10.按照权利要求9所述的施加器，其中所述联接组件包括连接在所述第二扳机与所述螺柱之间的丝线，其中所述丝线顺应所述第一夹钳和第二夹钳分别与所述杆之间的角度。
11.一种组织封闭系统，所述组织封闭系统包括：
杆；
第一夹钳和第二夹钳，所述第一夹钳和第二夹钳位于所述杆的远端部，其中所述第一夹钳和第二夹钳中的一个能够相对于另一个运动；
多个螺柱，所述螺柱能够相对于所述第一夹钳和第二夹钳缩回；
触发机构，所述触发机构与所述第一夹钳和第二夹钳中的一个可操作地相关联以使得所述夹钳相对于彼此闭合并且当包含能够穿刺组织的紧固件的挤压体被定位在所述第一夹钳和第二夹钳之间时在组织上部署所述挤压体；以及
其中所述触发机构能够在致动并且所述挤压体被定位在所述第一夹钳和第二夹钳之间时按顺序引起以下动作：(i)使得夹钳相对于彼此闭合并且部署所述紧固件，(ii)从所述紧固件缩回螺柱，以及(iii)使得夹钳相对于彼此打开。
12.按照权利要求11所述的组织封闭系统，其中所述第一夹钳和第二夹钳在相对于所述杆的轴线成10度至20度的范围的角度设置的平面中打开和闭合。
13.按照权利要求11所述的组织封闭系统，其中所述挤压体具有两个带有相对的组织接合表面的腿部。
14.按照权利要求11至13中任一项所述的组织封闭系统，其中所述触发机构包括：
第一扳机组件，所述第一扳机组件与所述第一夹钳和第二夹钳中的至少一个可操作地相关联，以使得所述夹钳相对于彼此闭合并且部署所述挤压体；以及
第二扳机组件，所述第二扳机组件用于使多个螺柱脱离与紧固件的接触。
15.按照权利要求14所述的组织封闭系统，还包括：
所述挤压体；并且
其中所述第一扳机组件包括第一扳机，当使得所述第一扳机从第一位置运动到第二位置时，所述第一扳机用于使得所述第一夹钳和第二夹钳相对于彼此闭合并且部署所述挤压体。
16.一种系统，包括：
封闭装置；以及
按照前述权利要求1至10中任一项所述的施加器。
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2010
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- 2010-08-11 WO PCT/US2010/045216 patent/WO2011019848A1/en active Application Filing
- 2010-08-11 JP JP2012524852A patent/JP5807312B2/ja active Active
- 2010-08-11 EP EP10808715.6A patent/EP2464298B1/en active Active
- 2010-08-11 CN CN201080042063.3A patent/CN102573665B/zh active Active
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2015
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2017
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|---|---|
| WO2011019848A1 (en) | 2011-02-17 |
| JP6353574B2 (ja) | 2018-07-04 |
| US20110190809A1 (en) | 2011-08-04 |
| EP2464298B1 (en) | 2016-12-21 |
| JP2015157166A (ja) | 2015-09-03 |
| JP6166750B2 (ja) | 2017-07-19 |
| JP2013501588A (ja) | 2013-01-17 |
| JP2017104665A (ja) | 2017-06-15 |
| CN102573665A (zh) | 2012-07-11 |
| JP2018089478A (ja) | 2018-06-14 |
| JP5807312B2 (ja) | 2015-11-10 |
| US8647350B2 (en) | 2014-02-11 |
| EP2464298A1 (en) | 2012-06-20 |
| EP2464298A4 (en) | 2015-04-22 |
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