CN1856280B - 具有植入力分解的基于导管的紧固件植入装置和方法 - Google Patents

具有植入力分解的基于导管的紧固件植入装置和方法 Download PDF

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CN1856280B
CN1856280B CN2004800276497A CN200480027649A CN1856280B CN 1856280 B CN1856280 B CN 1856280B CN 2004800276497 A CN2004800276497 A CN 2004800276497A CN 200480027649 A CN200480027649 A CN 200480027649A CN 1856280 B CN1856280 B CN 1856280B
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李·博尔达克
朱昂·C·帕罗迪
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Aptus Endosystems Inc
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Abstract

本发明提供将紧固件植入目标身体区域如空心体腔或管腔内空间中的装置和方法。该装置和方法在目标身体区域中部署携带有致动件的紧固件连接组件。致动件可选择性地进行操作以产生植入力从而将紧固件植入到目标身体区域内的组织中。可植入紧固件用于例如固定假体如血管内移植物。该系统和装置在致动件上或其附近施加分解力，从而使得有可能得到稳定的和可靠的基于导管的紧固平台。

Description

具有植入力分解的基于导管的紧固件植入装置和方法
相关申请
本申请要求2002年11月29日提交的待决的美国专利申请10/307,226的优先权。本申请还要求2002年10月5日提交的待决美国专利申请10/271,334的优先权。本申请还要求2002年3月15日提交的待决美国专利申请10/099,149的优先权，其为1999年9月17日提交的标题为“Endovascular Fastener Applicator”的美国申请09/787,135的分案申请，该分案申请要求了1998年9月18日提交的美国临时申请60/101,050的优先权，并且其还要求2000年8月18日提交的标题为“Endovascular Device for Application of Prosthesis with Sutures”(现在为美国专利6,336,933)的美国专利申请09/640,554的优先权，其为1999年3月10日提交的标题为“Endovascular Device for Application ofProsthesis with Sutures”(现在已被放弃)的美国专利申请09/266,200的继续，并且其还要求1998年3月13日提交的标题为“EndovascularDevice for Application of Prosthesis with Sutures”的阿根廷专利申请P19980101145的优先权。本申请还要求2001年11月28日提交的待决美国临时申请60/333,937的优先权。
技术领域
本发明总地涉及将假体递送到身体内的目标位置，如，用于空心体器官和/或血管的患病和/或损坏部分的修补。
背景技术
血管壁由于破坏或疾病而弱化可以导致血管膨胀和动脉瘤的形成。如果不经治疗，动脉瘤可增大并可能最终破裂。
例如，主动脉的动脉瘤通常主要发生在腹部，通常在肾动脉和大动脉分叉之间的肾下区域中。动脉瘤也可发生在主动脉弓和肾动脉之间的胸部。主动脉瘤的破裂引起大出血并且具有很高的死亡率。
血管患病或损坏部分的开腔式手术(open surgical)可以消除血管破裂的危险。在这种方法中，除去血管的患病或损坏部分并安装假体移植物(graft)(为直形或分叉结构)，然后通过缝合使其永久地连接和密封于原有血管(native vessel)的端部。用于这些方法的假体移植物通常为无支撑的织物管，并且典型地由聚酯、ePTFE或其它适合的材料制成。移植物为纵向无支撑的，因此它们可以适应动脉瘤和原有血管形态的改变。然而，这些方法需要大的手术切口并且具有很高的发病率和死亡率。另外，许多患者由于其它共存疾病(co-morbidity)不适合这种类型的大手术。
已经引入了血管内动脉瘤修复术以克服与开腔式手术修复术有关的问题。将动脉瘤用管腔内放置的血管假体桥接。典型地，用于主动脉瘤的这些假体移植物在导管(catheter)上折叠递送通过股动脉。这些移植物通常设计为使用与膨胀的、或经膨胀以接触血管内径的金属架(-展伸架)结构连接的织物材料。与开腔式手术动脉瘤修复术不同，管腔内部署的移植物没有被缝合到原有血管，而是依靠在部署过程中刺入原有血管中的从展伸架伸出的倒钩、或使用展伸架(stent)自身的径向膨胀力，保持移植物在适当的位置。与缝合相比，这些移植物连接方法不能提供相同水平的连接，并且可能在部署时破坏原有的血管。
发明内容
本发明的一个方面提供将紧固件植入到目标身体区域中如空心体器官或管腔内空间中的装置和方法。该装置和方法在目标身体区域中部署包括致动件的紧固件连接组件。致动件可选择性地进行操作以产生植入力，从而将紧固件植入到目标身体区域内的组织中。可植入紧固件用于例如固定假体。假体可包括如血管内移植物，可对其进行部署而不破坏动脉或静脉系中原有的血管。血管内的移植物可以包括例如径向膨胀的血管展伸架和/或展伸架-移植物。移植物可以处于脉管系统中，如，用于排除或桥接动脉瘤，如腹主动脉瘤。移植物如所希望的那样适应动脉瘤形态的改变并修复血管内的动脉瘤。紧固装置和方法可以部署通过脉管系统并从体外进行控制，以递送紧固件从而将移植物与血管壁连接。
根据本发明的这一方面，该系统和装置施加分解力(resolutionforce)，以抵消或对抗一些或全部或显著部分的植入力。期望在血管腔(或其它空心体器官)本身内分解一些或全部或显著部分的植入力，并且优选尽可能接近植入位置，从而使得有可能得到稳定的和可靠的基于导管的紧固平台。
在一个实施方案中，分解力包括作用于血管或空心体器官的壁上的通常期望与植入位置相对的位置的基本上相等和相反的反作用力。
在一个实施方案中，致动件包括驱动件，用于植入螺旋状紧固件。然而，致动件可以包括用于使用如超声波、激光、或撞击(impact)原理施加植入力的任何结构。
在一个实施方案中，该系统和方法包括引导部件和紧固件施用器(applier)部件。引导部件引导紧固件施用器部件和/或将其定位在所需的植入位置或其附近。在这种布置中，引导部件可以包括用于稳固引导部件的位置的装置(means)，从而提供分解力；和/或引导部件可以使其本身的尺寸适合于并被构建为在有或者没有另外的稳固装置(稳固装置)的存在下提供充分的分解力。在另一个方案中，紧固件施用器部件可以使其本身的尺寸适合于并被构建为在有或者没有另外的稳固装置的存在下、和有或者没有由引导部件提供的分解力的存在下提供充分的分解力。
在一个实施方案中，稳固装置可以包括可膨胀的构件、膜、连接和/或其它机械系统，以将引导部件稳固在空心体器官或血管内。稳固装置也可包括用于在植入紧固件之前抓住和/或锚定到空心体器官、血管或假体的壁上的装置。抓住或锚定装置可以包括穿透针和/或钩或倒钩。
在一个实施方案中，稳固装置可以与紧固件施用器部件联接，或者为稳固装置与引导部件联接的组合。
在一个实施方案中，稳固装置可采取与引导部件和施用器部件分离的稳固装置的形式。在这种方案中，分离的稳固装置用于与引导部件和/或紧固件施用器部件协作。
附图说明
结合附图，可通过以下对优选实施方案的详细说明理解本发明，其中：
图1为表示为定位在腹主动脉瘤内部的血管内移植物递送装置的一个实施方案的透视图；
图2为图1的动脉瘤内的血管内移植物的部署的一个实施方案的透视图；
图3为完全部署的图2的直型血管内移植物的透视图；
图4为表示在一个端部上的锚定支架的被破坏的完全部署的分叉形血管内移植物的透视图；
图5为类似于图4以表示替代性的锚定支架结构的透视图；
图6为表示用于引导紧固件施用器的装置的一个实施方案的透视图；
图7为表示当图6装置插入图3中部署后的血管内移植物内时移植物和锚定支架都被破坏的图6装置的透视图；
图8为表示与引导部件连接的稳固装置的一个实施方案的致动的图6装置的透视图；
图9为铰接(articulating)图6的引导部件的图8中的控制组件的透视图；
图10为图8的稳固装置的替代性实施方案的透视图；
图11为表示图10的替代性稳固装置的致动的透视图；
图12为表示图8的稳固装置的另一个实施方案的透视图；
图13为表示图12的稳固装置的致动的透视图；
图14为紧固件施用器的一个实施方案；
图14A为图14中所示紧固件施用器的远端的放大图，表示紧固件驱动机构的细节；
图14B为图14中所示紧固件施用器的手柄的内部剖视图；
图15为置于图6的引导部件内的图14的紧固件施用器的透视图；
图16为图14的紧固件施用器的一个实施方案的放大剖视图；
图17为连接施用器的放大剖视图，表示螺旋状紧固件的近端和驱动机构的一个实施方案；
图18为图16的螺旋状紧固件的一个实施方案的放大透视图；
图19为连接施用器的放大图，表示致动紧固件施用器的控制组件的一个实施方案；
图20为紧固件植入到移植物和血管壁中的通过致动实施连接的放大图；
图21为用紧固件将图3的近端的移植物完全连接于血管壁的放大图；
图22为完全连接于血管的图4的移植物的透视图；
图23为图14中所示紧固件施用器的驱动机构的放大剖视图，表示在没有紧固件和目标组织区域之间的所需接触时，禁止施用器工作的接触/力传感组件；
图24为图14中所示紧固件施用器的驱动机构的放大剖视图，表示响应紧固件和目标组织区域之间的所需接触，使施用器工作的接触/力传感组件；
图25A和图25B为紧固件施用器的远端的放大图，表示紧固件驱动机构的替代性实施方案的细节；
图26A为图25A和图25B中所示紧固件施用器的驱动机构的放大剖视图，表示在没有紧固件于目标组织区域之间的所需接触时，禁止施用器工作的接触/力传感组件；
图26B和图26C为图25A和图25B中所示紧固件施用器的驱动机构的放大剖视图，表示响应紧固件和目标组织区域之间的所需接触，使施用器工作的接触/力传感组件；
图27为可用于与图14、图23、和图24中所示紧固件施用器联接的螺旋状紧固件的透视图；
图28A为可用于与图25A和图25B中所示紧固件施用器联接的螺旋状紧固件的透视图；
图28B为可用于与图26A到图26C中所示紧固件施用器联接的螺旋状紧固件的透视图；
图29为可用于不使用单独的引导部件而部署图27中所示螺旋状紧固件的具有倾斜的施用器端部的紧固件施用器的放大侧视图，部分为剖视图；
图30为可用于不使用单独的引导部件而部署图27中所示螺旋状紧固件的具有倾斜的紧固件施用器的替代性实施方案的放大侧视图，部分为剖视图；
图31为可用于不使用单独的引导部件而部署图27中所示螺旋状紧固件的具有倾斜的紧固件施用器的替代性实施方案的放大侧视图，部分为剖视图，紧固件施用器具有铰接的施用器端部；
图32为表示位于腹主动脉瘤内的血管内假体的透视图，假体包括一体化的紧固件组件；
图33为图32中所示的血管内假体的透视图，管腔内工具被部署以与一体化的紧固件组件操作性地相互作用，用于将假体暂时或永久地锚定于血管壁；
图34为形成图33中所示一体化的紧固件组件的一部分的紧固件的侧视图，紧固件具有茎，其表示为在将其与一体化的紧固件组件联接之前正常为舒展开的状态；
图35为图34中所示紧固件的侧视图，紧固件的茎目前表示为关闭状态并且被容纳索眼内，索眼构成了一体化的紧固件组件的一部分；
图36和37为表示使用图33中所示管腔内工具施加力以将紧固件从其图35中所示位置推动并穿过血管壁的侧视图；
图38为部署为将假体锚定于血管壁后的一体化的紧固件组件；
图39为表示使用追踪线(tracking wire)以引导管腔内工具与紧固件接触，从而可以施加力以推动紧固件穿过血管壁的侧视图；
图40为假体递送导管的实施方案，其用于其中展伸结构只覆盖假体的一部分的假体，导管包括稳固支柱的阵列以帮助假体保持在适当的位置，对抗血液的流动；
图41为假体递送导管的另一个实施方案，其用于其中展伸结构只覆盖假体的一部分的假体，导管包括翻转的稳固支柱阵列以帮助假体保持在适当的位置，对抗血液的流动；和
图42为假体递送导管的另一个实施方案，其用于其中展伸结构只覆盖的假体一部分的假体，导管包括稳固笼以帮助假体保持在适当的位置，对抗血液的流动。
图43为替代性的稳固装置的正视图，其包括组织抓紧件(tissuegripping element)。
图44A和44B为携带作为稳固装置的可膨胀笼状结构的紧固件施用器的正视图，图44A表示用于血管内部署的通常为折叠状态的笼状结构，图44B表示处于抵靠血管壁和移植物的膨胀状态的笼状结构，用于部署紧固件。
图45图解表示血管或空心体器官内的植入力与反作用力的分解。
发明详述
I.递送假体
图1描述在体腔中穿过引导线12定位的血管内移植物递送导管10。导管10携带假体14(参见图2)，其通过例如假体14的径向膨胀(参见图3)定位在目标位置。在假体14部分或完全膨胀之后，通过紧固件连接组件(如随后更具体描述的)引入一个或多个紧固件28(参见图15和16)将假体14锚定在适当的位置。
为了说明，图1表示在腹主动脉瘤11内的目标位置。目标位置可以在身体内的别处。在说明性的方案中，假体14为血管内移植物的形式。
图2描述在目标位置部署移植物的初始阶段。虽然部署方法可以不同，在说明性的实施方案中，递送导管10具有覆盖移植物14的可移动的覆盖物13。当覆盖物13被向近端拉动时，移植物14自由地径向膨胀，从而扩大以接触血管的内壁。移植物14表示为自膨胀。或者，移植物14可以利用膨胀件，如气球或机械膨胀机。
继续移植物的部署过程，直到移植物14在血管内被完全部署或被部分地部署。移植物14的尺寸可适合于或被构建为直形或分叉形式。图3描述完全部署的直形移植物14。图4描述完全部署的分叉形移植物15。
A.假体
期望移植物14包括支撑框架或支架16。支架16可为弹性的，如，由形状记忆合金弹性不锈钢等制成。对于弹性支架，膨胀典型地包括在植入位置松脱支架使其解除约束，从而允许支架自膨胀。在说明性的方案中，覆盖物13起径向约束件的作用。或者，在支架16外面布置管状导管(递送鞘)等，可以用于维持支架处于径向缩小的构造。在这种布置中，支架16的自膨胀通过向后拉动径向约束件以允许支架16呈现其更大的直径构造而实现。
或者，可将支架16以轴向延长的构造被约束，例如通过将支架的任一端与内部的管、杆、导管等连接。这保持支架16处于延长的、直径缩小的构造。然后可将支架16从这种轴向约束构造中解除以允许其自膨胀。
或者，支架16可由有延展性的材料形成，如由延展性的不锈钢或其它金属形成。然后膨胀可包括在支架内施加径向膨胀的力以引起膨胀，如，使支架内的支架递送导管膨胀以实现膨胀。在这种布置中，内移植物(endograft)的定位和部署可通过使用单独的、或引入到部署导管中的膨胀装置而实现。这使得允许内移植物在血管内定位并进行部分部署，同时检查在血管内的相对位置。膨胀可以通过气球或机械膨胀装置实现。另外，这种膨胀通过抵抗血液对内移植物的力，使内移植物稳固在动脉内的位置，直到内移植物可以完全部署。
移植物14可具有多种常规的构造。其可以典型地包括由可采取展伸(stent)结构形式的支架16支撑的织物或一些其它血液半不透性的挠性屏障。展伸结构可具有任何常规的展伸结构，如锯齿形、蛇形、膨胀的菱形、或其组合。展伸结构可延伸到移植物的整个长度，并且在有些情况下可以比移植物的织物构件更长。或者，展伸结构可仅仅覆盖假体的一小部分，如，存在于端部。当其构建为用于治疗分叉血管区域(如，腹主动脉瘤的治疗)时，当将展伸移植物延伸到回肠动脉中时，展伸结构可具有三个或多个端部。在某些情况中，展伸结构可以沿着展伸结构-移植物的整个长度或至少整个长度的主要部分间隔布置，其中单独的展伸结构不是彼此直接连接，而是连接于移植物的织物或其它挠性部件。
移植物支架16或展伸结构的一个说明性的实施方案在图4中的被破坏的区域中进行说明。其中，展伸结构为简单的Z形图案形式，然而，考虑了展伸设计可如图5中所述的更复杂的图案17。虽然在图4和图5中只描述了移植物内的一种展伸结构，但是，如前所述，可以将多个独立的展伸结构并入到移植物中。
图40表示假体递送导管600的实施方案，涉及其中展伸结构16只覆盖假体的一部分(如只存在于端部)的假体14。如图40所示，假体递送导管600(其表示为穿过引导线610部署)包括稳固支柱612的阵列，其与假体14端部的展伸结构16以可松脱的方式结合，如，通过拉动穿过导管600中的腔的拉带(未表示)而松脱的接缝结合。稳固支柱612保持自膨胀的展伸结构16抵靠血管壁34的适当位置，假体14的其余部分正在部署(通过收回递送鞘614)。在假体部署过程中，支柱612支撑展伸结构16(因此支持整个假体14)对抗通过血管的血流的力。导管600也可在其远端包括头锥体618，以将血流朝向血管壁散布，帮助在部署过程中支撑假体14。在假体14部署之后，可以通过拉动拉带以松脱接缝，使支柱612从展伸结构14分离，并且导管600沿着引导线610被收回穿过递送鞘614(从展伸结构16松脱的支柱612在导管600穿过递送鞘614的过程中折起来)。
图41表示假体递送导管700的替代性实施方案，涉及其中展伸结构16只覆盖假体的一部分(如只存在于端部)的假体14。如图40所示，假体递送导管700(其也表示为穿过引导线710部署)包括翻转的稳固支柱阵列712，其在假体14的端部与展伸结构16以可松脱的方式结合，如，通过拉动穿过导管700中的腔的拉带(未表示)而松脱的接缝结合。翻转的稳固支柱712，和图40中所示的支柱612一样，保持自膨胀的展伸结构16抵靠血管壁34的适当位置，同时假体14的其余部分正在部署(通过收回递送鞘714)。与图40中的导管600一样，导管700也可包括在其远端的头锥体718，以使血流朝向血管壁散布。在假体14部署之后，可以通过拉动拉带(未表示)将支柱712从展伸结构16松脱，并且导管700沿着引导线710被收回通过递送鞘714(从展伸结构16松脱的支柱712在导管700穿过递送鞘714的过程中折起来)。
图42表示假体递送导管800的另一个替代性实施方案，涉及其中展伸结构16只覆盖假体的一部分(如只存在于端部)的假体14。如图42所示，假体递送导管800(其也表示为穿过引导线810部署)包括自膨胀的稳固笼812。稳固笼812保持自膨胀的展伸结构16抵靠血管壁的适当位置，而假体14的其余部分正在部署(通过收回递送鞘814)。与图40和图41中的导管600和700一样，导管800也可包括在其远端的头锥体818，以使血流朝向血管壁散布。在假体14完全部署之后，当导管800沿着引导线810被收回穿过递送鞘814时，稳固笼可处于折叠状态。
在所有刚才描述的实施方案中，如果在引入紧固件28之前假体14已经完全部署、和/或假体递送导管600、700、或800已经从目标位置收回，可随后使用引导线610、710、810，将用于假体14的紧固件连接组件部署到目标位置，如以下更详细描述的。或者，如果在施加紧固件28时假体14没有完全部署，或如果由于任何理由，不期望收回假体递送导管600、700、或800时，可将假体递送导管600、700、或800及其各自的引导线610、710、810保持在目标位置，同时将用于假体14的紧固件连接组件随来自另一个身体进口点的单独的引导线引入到目标位置。在这种方案中，假体14的部署和/或假体递送导管600、700、或800的收回可在已经施加紧固件28之后完成。
II.固定假体
在所需的实施方案中，提供紧固件连接组件，使得有可能进行管腔内的紧固件连接。连接组件可具有不同构造。
A.两部件的紧固件引导和连接组件
在一个方案中，紧固件连接组件包括紧固件引导部件18和紧固件施用器部件27。期望引导部件18具有穿过引导线12进行初始部署的可操纵的或可偏转的远端末梢。在说明性的实施方案中使用时，用于递送和定位假体14的引导线12保持在血管内，用于随后的紧固件引导部件18的部署。或者，可使用来自不同的身体进口点的另一个引导线，用于紧固件引导部件18的部署。在任一种布置中，期望在除去已经递送引导部件18的引导线之后，通过引导部件18部署紧固件施用器部件27。紧固件施用器27携带至少一个紧固件28和用于推进紧固件28的紧固件驱动机构100，使得其穿透假体14和下面的血管壁，从而将假体14稳固地锚定在适当的位置。
1.紧固件引导部件
图6描述了形成紧固件连接组件的一部分的引导部件18的一个实施方案。引导部件18包括适合密闭件(obturator)19通过的内腔。密闭件19具有用于允许随着引导线12递送引导部件18的腔，如图7所示。一旦在所需位置部署，则除去密闭件19和引导线12，使中央的腔空着，用于紧固件施用器部件27通过，这将在随后描述。
在说明性的实施方案中(参见图8)，引导部件18包括控制组件21。在一个实施方案中，控制组件21的特征为可移动的轮或控制杆22，其以常规的方式操纵内部的操纵线，使得引导部件18的远端末梢23朝向所需位置偏转，如图9所示的。考虑了用于引导部件18的控制组件21可以机械、电力、液压、或气压的方式启动。控制组件21具有通道腔，以允许密闭件19穿过(如刚刚描述的)和紧固件施用器部件27穿过(如以下描述的)。
2.紧固件施用器部件
图14表示形成紧固件连接组件的一部分的紧固件施用器部件27的一个实施方案。如图15所述，紧固件施用器部件27通过引导部件18的中央腔部署到要安装紧固件28的位置。
位于紧固件施用器部件27远端(参见图14)的是紧固件驱动机构100。在说明性的实施方案中(参见图14A)，驱动机构100包括与托架102结合的驱动器29。驱动器29和托架102之间的结合可采取不同的形式，如，磁体、抓紧器、或其它适合的机械连接。在图14A的说明性实施方案中，驱动器29和托架102连接为一体形成单个单元。
托架102尺寸适合于并构建为与所选的紧固件28接合。在图14A中，紧固件采取图18和图27中所示类型的螺旋状紧固件的形式。如图27中所最好表示的，和如随后更详细描述的，图26中的螺旋状紧固件28为具有尖锐的前导末梢142的开圈148。紧固件28的近端144包括L-形腿146。期望L-形腿146将开圈148的整个内径二等分；也就是说，L-形腿146完全延伸跨过开圈148的内径，如图27所示。L-形腿146用来与紧固件施用器27的托架102接合，托架102使螺旋状紧固件转动以实现植入。L-形腿146还起到阻止螺旋状紧固件穿透进入组织中太深的止动装置的作用。
图14A中的托架102包括狭缝180，其接受L-形腿146以与随托架102转动的紧固件28结合。开圈148的转动停止在围绕托架102的互补凹槽32中。凹槽32可以沿着紧固件28的整个长度定位，或在其长度的一部分内定位。
当然，驱动机构100的致动可以不同的方式实现，如，机械的(即，手动的或手工的)、电动的、液压的、或气动的方式。在说明性的实施方案中(参见图14B)，驱动电缆30将紧固件驱动器29与施用器控制杆108中携带的马达106连接。期望驱动电缆30由允许弯曲和转动的适合的材料制成。在马达106(其又在马达控制器31的控制下，如随后描述的)的驱动下，驱动电缆30使驱动器29转动，随着驱动器29的转动，托架102转动。托架102赋予用于植入组织的螺旋状紧固件28以转动和扭矩。
图16为紧固件施用器27和引导部件18的放大剖视图。图17为紧固件施用器27的放大剖视图，其中紧固件驱动器29的剖面图描述了紧固件驱动器29和螺旋状紧固件28之间的接合。图19描述了在紧固件驱动机构100致动过程中的紧固件施用器27。驱动机构100的致动使作为单元的驱动轴30、驱动器29、托架102和螺旋状紧固件28转动。这种转动引起螺旋状紧固件28移动进入紧固件施用器的内部凹槽32并进入假体14和血管壁34(参见图20)。图21说明移植物14对血管壁34的完整的螺旋状紧固件28连接。
在使用中，施用器部件27前进通过引导部件18并与假体接触。操作者通过接触控制开关110启动控制器31(参见图14和图14B)。这一致动引起螺旋状紧固件28转动离开托架102并穿过假体14进入血管壁34。期望马达控制器31在每次开动命令时以特定的转数转动驱动电缆30。这可以通过引入机械的或电子的计数器而实现。
随着紧固件28的部署，将紧固件施用器部件27通过引导部件18收回，并将另一个紧固件28装载到托架102中。将引导部件18再定位，并再一次推进施用器部件27通过引导部件18并与假体14接触。操作者再一次通过接触控制开关110启动控制器31，以部署另一个紧固件28。在假体14的近端和/或远端重复该过程，直到假体14被适当地连接并密封到血管壁34。考虑可在假体14的每个端部使用约两个到约十二个紧固件28以实现锚定。紧固件28的施加可以单一的周向间隔开的一排、或以多于一排进行施加，其中单个的紧固件为轴向排列或周向地交错排列。
图22说明在近端和远端连接到血管壁的移植物假体的透视图。考虑了本发明可用于直形和分叉形移植物在主动脉和其它分支血管内的移植物连接。
驱动机构100的替代性实施方案如图25A和图25B中所示。在这个实施方案中，驱动器29与构成螺旋状紧固件28自身的一部分的托架150连接，还有如图28A中所示的。如图28A所示，与图27中所示的紧固件一样，螺旋状紧固件28为具有尖锐的前导末梢142的开圈148。紧固件28的近端144包括托架150。
托架150包括狭缝182。狭缝182与驱动器29上的驱动凸缘184接合(参见图25A)，用于在植入步骤过程中转动驱动器29以使螺旋状紧固件28转动。与图27中所示的紧固件的L-形腿一样，托架150还起到阻止螺旋状紧固件穿透进入组织者太深的止动装置的作用。
托架150和驱动器29的连接接合可以多种方式实现，例如通过单独的抓紧器或抓爪、磁结合、或任何其它适合的机械连接方式。在说明性的实施方案中，驱动器29由磁化材料组成，托架150由被磁化材料磁吸引的材料组成。当然，可使用相反布置的磁化材料和被磁性吸引的材料。
在这个布置中，驱动电缆30和马达106之间的马达结合132适应驱动电缆30的轴向位移(在图25A和图25B中向左和向右)而不中断与马达106之间的驱动连接。当施用器装置27的远端末梢与假体14接触时(参见图25A)，操作者通过接触控制开关110启动控制器31。控制器31命令马达106转动驱动电缆30，从而使驱动器29和磁连接的螺旋状紧固件28转动。这种致动引起磁连接的螺旋状紧固件28转动进假体14和血管壁34中(参见图25B)。由于磁连接，随着紧固件28部署到图25B中的左侧，驱动器29与托架150以合作的方式移动(也在图25B中的左侧)。由于托架150和驱动器29之间的磁连接，操作者必须施加故意的分离力以从驱动器29分离托架150(和，分离紧固件28)。这一布置防止紧固件28的意外松脱。
如前所述，随着紧固件28的部署，将施用器部件27收回通过引导部件18，并将另一个紧固件28与驱动器29磁连接。将引导部件18再定位，并再一次推进施用器部件27通过引导部件18并与假体14接触。操作者再一次通过接触控制开关110启动控制器31，以部署另一个紧固件28。在假体14的近端和/或远端重复该过程，直到假体14被适当地连接并密封到血管壁34。
如上述说明中所描述的，期望施用器部件27的外径尺寸适合于和构建为穿过引导部件18的采取适当的可操纵引导导管形式的腔，以引导施用器部件27到达所需位置。还如上所述，期望施用器部件27构建为每次插入一个紧固件28(所谓的“单击发射”方法)。这被认为是合乎需要的，因为其降低了设计的复杂性并且适合施用器部件27进入通过曲折的解剖体组织构造。携带单个紧固件的紧固件施用器部件27可比携带多个紧固件的紧固件施用器的型面高度低并且可能更有效和产生更小创伤。然而，在替代性的实施方案中，如果期望，施用器部件27可构建为携带多个紧固件。此外，紧固件施用器27可同时部署上述优选的周向间隔开的空间图案的多个紧固件。
3.力的分解
使用施用器部件27将紧固件28刺穿并植入到组织中需要施用器部件27在假体14和血管壁34上或其附近施加植入力。在说明性的实施方案中，施用器部件27包括用于植入螺旋状紧固件的驱动件。然而，施用器部件27可以包括使用如超声波、激光、或撞击原理的实际上任何的用于施加植入力的致动件。
无论是哪种产生植入力的具体方法，期望施用器部件27的植入力以某种方式被分解，以提供位置稳定性和抵抗施用器部件27相对于植入位置的意外运动。换句话说，期望施加分解力以抵消和/或对抗施用器部件27的植入力。在血管腔(或其它空心体器官)自身内分解一些或全部或显著部分的植入力是合乎需要的，并且优选尽可能接近植入位置。引导部件18的管状体和/或紧固件施用器部件27的心轴可为尺寸适合于并构建为具有足够的柱强度(column strength)以在血管腔或空心体器官内分解一些或全部或至少一部分植入力。另外或替代性的，引导部件18和/或紧固件施用器部件27可以包括稳固装置20，用于在植入紧固件的紧固件施用器部件27的驱动件上或其附近施加反作用力。
说明性的实施方案表示稳固装置20的多种替代性实施方案。如图8和图9中所示，稳固装置20为引导部件18上的用于接触组织的弹簧加压臂的形式。在这种布置中，当从引导部件18除去密闭件19和引导线12时，将弹簧加压的稳固装置20进行部署定位(参见图8)。在图10和图11中所示的替代性实施方案中，稳固装置20为引导部件18上的接触组织的可移动的支柱组件24的形式。在这种替代性的布置中，可移动的支柱组件24可以通过例如控制组件上的控制杆25开动(参见图11)。在两个实施方案(图7和图10)中，稳固装置20都位于引导部件18端部的远端。在图12中所示的替代性实施方案中，稳固装置20为与引导部件18的远端末梢相邻的可膨胀件26的形式。在这种替代性布置中(参见图13)，可膨胀件26可以通过例如控制组件21上的控制杆25开动。然而，还考虑了这种类型的稳固装置20也为可充气的。在另一个替代性的实施方案(参见图43)中，稳固装置20包括由引导部件18和/或紧固件施用器部件27携带的装置200，用于在植入紧固件之前抓住和/或锚定于空心体器官、血管或假体的壁。抓住或锚定装置200可以包括在植入紧固件之前由控制组件等部署的穿透针和/或钩或倒钩。
在所有的实施方案中，稳固装置20可用于在血管内周向地或偏心地稳固引导部件18。
当然，稳固装置20的这些替代形式中的任一种与紧固件施用器27的联接方式类似于其与引导部件18的联接方式，或采取具有相等功能的稳固机构的一些其它形式。在另一个实施方案中，稳固装置20可为用于与引导部件18和/或紧固件施用器部件27合作的单独的稳固装置。在这种布置中，单独的稳固装置可以采取上述稳固装置的替代形式中的任一种、或为稳固机构的一些其它形式。
例如(参见图44A和图44B)，紧固件施用器27可以在其远端携带可膨胀的笼202或笼状结构。笼结构202围绕紧固件驱动机构100，其已预先进行描述。笼结构202可在通常为折叠状态的型面高度不大的形态(如图44A中所示)和在紧固件驱动机构100周围的膨胀形态(如图44B中所示)之间操作。
在通常折叠的状态中，可以将紧固件施用器27部署通过血管进入移植物14的附近。图44A表示移植物14包括自膨胀的支架16。当处于通常折叠的状态时，紧固件施用器27可以其型面高度不大的形态独立地、或通过所联接的可操纵的或不可操纵的引导部件18或适当的引导鞘部署通过脉管系统，到达目标移植物位置。
当处于移植物位置(参见图44B)时，笼结构202可以膨胀(如，通过适当的推挽控制机构)接触移植物14。可以在膨胀的笼结构202内设法使紧固件施用器27接触移植物14并如前所述进行操作以部署紧固件28。笼结构202用于分解至少一些植入力，以提供位置稳定性和抵抗紧固件施用器27的意外移动。
在所有这些替代性的实施方案中，稳固装置20的作用为在血管内对血管壁上的位置处施加基本上相等但是相反的反作用分解力，期望所述位置通常与植入位置相对(参见图45)。如刚刚描述的，所联接的引导部件18和/或紧固件施用器27的柱强度也可用于与稳固装置20协作以分解植入位置处的管腔内植入力。
引导部件18和/或紧固件施用器部件27提供的力的分解作用用于平衡或对抗或分解施用器部件27的组织穿入和植入力。因此，力的分解作用还阻碍施用器部件27相对于植入位置的移动，从而使得有可能形成稳定的和可靠的管腔内(或器官内)的紧固平台。
4.假体/组织接触传感
期望紧固件施用器部件27具有当施用器部件27末梢以所需程度接触假体或组织表面前防止马达106致动的作用。这防止紧固件28的意外放出和/或紧固件28的分离。这种作用可以使用例如机械设计或电设计的接触传感器或力传感器而实现。
当紧固件施用器部件27为图14A、14B、和14C中所示类型(参见图23和24)时，接触或力传感作用可以例如利用托架102的远端末梢120以传输接触力。这种力可以被传输到位于例如紧固件施用器手柄108内部的力或接触传感开关122。在这种布置中，开关122可为致动器开关110和控制器31之间的电路的一部分。
在说明性的实施方案中，开关122包括固定的开关元件128(结合到手柄108的内部)和可移动的开关元件130(由驱动电缆31携带)。在这种布置中，驱动电缆30和马达106之间的马达连接132适应马达电缆30的轴向位移(在图23和24中为向左和向右)而不中断与马达106的驱动连接。驱动电缆30通过轴承134与可移动的开关元件130连接，使得开关元件130响应驱动电缆30的移动而移动。固定的开关元件128不与可滑动通过开关元件130的可移动的驱动电缆30连接。
由于这种布置，驱动电缆30的轴向位移使开关元件130相对于开关元件128移动。更具体地，驱动电缆30向图23中左侧的位移使开关元件130向左侧移动，远离开关元件128。相反，驱动电缆30向图23中右侧的位移使开关元件130向右朝向开关元件128移动。
通常由弹簧126将开关元件128和130偏置分开，形成电学上的断开状态。在这种状态中，启动开关110的操作不用于启动控制器31，因为电断开的开关122中断了致动信号到马达控制器31的传递。当开关元件128和130处于电断开状态时，驱动电缆30向左侧转移以将托架末梢120定位为超出紧固件施用器27的远端末梢124。因此，托架末梢120可在施用器末梢124之前与假体14或组织接触。
当托架末梢120以足够的力接触假体或组织表面以压缩弹簧126时，驱动电缆30对着弹簧的偏置力向图23中的右侧移动。这使得开关元件130向右移动。最终，发生开关元件128和130之间的接触，如图24所示。接触建立了电闭合的状态。在这种状态中，启动开关110的操作用于启动控制器31。如图23和24中所示，可以提供接触螺钉136，以调整将开关元件128和130闭合需要的位移量。
在除去接触力或没有足够的接触力时，弹簧126推动开关元件128和130到电断开的状态。托架102的远端末梢远远地超出施用器27的远端末梢。
应该理解，无需在驱动电缆30的整个长度上发生托架末梢120向开关122的平移。例如，开关122可以托架102和驱动器29之间的平移间隔定位。在这种布置中，与驱动电缆30连接的驱动器29无须适应轴向位移。反而，根据与假体14的接触，托架102朝向驱动器29的相对运动会将托架10与驱动器29机械结合(如，通过类似于图25A和图25B中所示的狭缝和凸缘连接)，同时还闭合开关122，以开通致动器开关110和马达控制器31之间的电路。
当紧固件施用器部件27为图25A和图25B中所示类型(参见图26A、26B、和26C)时，接触或力传感作用可以利用例如以滑动方式通过托架150′(托架150′如图28B中所示)、驱动器29和驱动电缆30中的中心通道192的力传感杆190。杆190与可移动的开关元件130结合。在这种实施方案中，开关元件130在驱动电缆30上向左或向右平移，驱动电缆30在开关元件130内的轴承134上转动。
如前述实施方案中所述，弹簧126通常地将开关元件128和130偏置分开，形成电断开的状态。当开关元件128和130处于电断开状态时，力传感杆190向左侧移动超出紧固件施用器部件27的远端末梢124。因此，力传感杆190在施用器末梢124之前与假体14或支架结构16接触。
当杆190以足够的力接触假体或支架结构的表面以压缩弹簧126时，杆190对着弹簧126的偏置力向图26A中的右侧位移。这使得开关元件130向右移动。最终，发生开关元件128和130之间的接触，如图26B所示。接触建立了电闭合的状态。在这种状态中，启动开关110的致动用于启动控制器31。这种致动使得螺旋状紧固件28转动进入支架结构16中和血管壁34中(参见图26C)。由于驱动器29和托架150′之间的磁连接，随着紧固件28被部署，驱动器29与所连接的托架150′以合作的方式向图26B中的左侧移动。此外，由于托架150和驱动器29之间的磁连接，操作者必须施加分离力以从驱动器29分离托架150(并分离紧固件28)。如前所述，这种布置防止了紧固件28的意外松脱。可以提供接触螺钉136以调整闭合开关元件128和130所需的位移量。
在除去接触力或没有足够的接触力时，弹簧126推动开关元件128和130到电断开的状态，移动杆190的末梢移动超出施用器27的远端末梢124。
刚刚描述的接触或力传感布置也可产生对操作者的听觉和/或视觉输出，以表明在施用器装置27和假体或组织之间的足够的接触力的存在。
B.倾斜的组件紧固件引导和连接组件
在另一个布置(参见图29)中，紧固件连接组件包括单一的、倾斜的紧固件引导和施用器部件160。在这种布置中，部件160包括将容纳紧固件28的托架164置于相对于假体或组织为垂直或接近垂直的位置的紧固件驱动机构162。这种构造消除了对前述的用于紧固件组件27的单独的可操纵的引导部件18的需要。
驱动机构162可以不同。在说明性的实施方案中(如图29中所示)，机构162包括与驱动电缆30连接的伞形驱动齿轮168。驱动齿轮168与连接于托架164的传动齿轮(transfer gear)或小齿轮170操作接合。驱动齿轮168和小齿轮170的转动轴以约九十度偏置，使得驱动电缆30沿血管轴的转动被转换为通常垂直于血管壁的托架164的转动。可以多种方式将紧固件引导和施用器部件160在血管内定位并稳定，如，通过使用外部的弹簧加压支柱等(如上述的与引导部件18结合的所示)、或通过利用可膨胀的元件166(如图29所示)。膨胀件166可以包括气球或机械臌胀装置。膨胀件166通过抵抗血液的力在血管内稳定假体和紧固件引导和施用器部件160的位置，直到假体可以被锚定。
如图30所示，如果期望，紧固件引导和施用器部件160可以提供驱动电缆30和托架164之间的略小于九十度的倾斜部署，以帮助托架对着血管壁进行垂直接触位置的管腔内操作。如图31所示，如果期望，紧固件引导和施用器部件160可以被铰接在驱动电缆30和托架164之间。在这种布置中，期望提供远程控制机构，以实现托架164从用于部署到目标位置的第一(通常为直形)位置(图31中幻线所示)到用于托架164对准抵靠血管壁的第二(铰接)位置(图31中实线所示)的移动。
III.紧固件
如前面已经说明和描述的，典型地，在假体14已被初始定位之后进行紧固件28的引入。也就是说，通过自膨胀或气球膨胀实现假体14的初始定位，然后，通过引入多个单独的紧固件将假体14固定或锚定在适当的位置上。紧固件28可只穿过假体14的织物定位，即，避开支架结构。或者，可以将紧固件28引入并穿过支架结构自身的多个部分。假体14可包括预先形成的特地构建为接受紧固件的插孔、孔、或索眼。紧固件28可穿过织物和穿过锚定支架结构被引入。紧固件可以沿假体14内壁周向地以间隔开的形式逐一地引入，即每次一个。
在示例性的实施方案中，紧固件28为螺旋状紧固件，使得它们可以转动并“旋进”假体14和血管壁中。所需的螺旋状紧固件28的形状(参见图27、28A和28B)为开圈148，很象螺旋弹簧。这种构造使得紧固件28可抓取较大面积的组织，产生比常规的U形钉显著更大的夹持力，而无需施加可能导致组织坏死的组织压缩。
如图27、28A、和28B所示，期望螺旋状紧固件28的前导末梢142为锋利的，使得其可穿透动脉壁和/或钙化组织。这种远端末梢142可为尖锐的，以切开穿过组织的螺旋状通路，或可为尖锐的，以穿透组织而没有切口。
紧固件的近端144具有两个设计功能。第一个功能是与植入过程中转动螺旋状紧固件的紧固件施用器27的托架102接合。第二个功能是起到防止螺旋状紧固件穿透进入组织中太深的止动装置的作用。
在一个实施方案(参见图27)中，螺旋状紧固件28的近端144包括将紧固件直径二等分的开圈148的L-形腿146。开圈148的腿146完全地跨过直径，用于防止紧固件为开圈的，并且用于控制刺入组织中的深度。另外，开圈148的腿146可以连接于先前的开圈以强化整个结构并且为紧固件施用器提供更稳定的驱动连接点。这种连接可以通过焊接、粘合剂、或任何其它合适的方式实现。
或者(如图28A和28B所示)，紧固件28的近端144可以引入单独的帽或托架150或150′，其起到与图27中开圈148的腿146相同的作用。托架150或150′以几种用于连接于紧固件施用器驱动机构100的方法为特征。这些方法包括单独的抓紧器或抓爪、磁结合(如前所述)、或任何其它适当的机械连接装置。在图28A和图28B中，托架150和150′包括狭缝180和182′，以与驱动凸缘配合(如前所述的)。还如前所述，在托架150和150′与相应的驱动件之间实现磁结合，以防止使用过程中的意外分离。
在图28B中，托架150′还包括通道152，用于容纳图26A、26B、和26C中所示的接触/力传感杆190。
图27、28A、和28B中所示的紧固件28可由不锈钢或其它类型的可植入金属制成，然而，还设想上述说明中的紧固件可由可植入聚合物或由可生物降解的聚合物或其所有材料的组合制成。期望地，紧固件28具有2到10个圈，并且为1mm到10mm长。单个开圈间的间距为0.25mm到3mm。紧固件28的直径为1mm到6mm。
IV.具有一体化的紧固件组件的假体
图32表示包括至少一个一体化的紧固件组件502的假体500。图32表示在目标管腔内区域部署的假体500，特别地在腹主动脉瘤504内部署。假体可以在身体内的别处部署。
期望假体500包括由支撑框架或支架504携带的织物材料等，如前所述。支架504可由在从鞘部署过程中径向自膨胀的弹性材料制成，或由响应由气球或机械臌胀装置在支架内施加的径向膨胀力而径向膨胀的延展性材料制成。
假体500在目标区域中部署之后，操作假体500上的一体化的紧固件组件502以将假体500锚定到血管壁。在说明性的实施方案中，假体500携带两个一体化的紧固件组件502，在假体500的每个端部区域中有一个。
在说明性的实施方案中，每个紧固件组件502都在加固的凸缘区域506各自的端部区域中被嵌入。每个紧固件组件502包括围绕凸缘506周向地间隔开的紧固件阵列508。阵列中的紧固件508的数目可以不同，例如在每个凸缘区域506上具有约两个到约十二个紧固件。阵列的排列也可不同，例如为周向排列，紧固件508也可以轴向地间隔布置。
紧固件508可由金属或塑性材料形成，并且可具有不同构造。在说明性的实施方案中，每个紧固件508包括圆盘形的头512和分叉为两个翼516和518的茎514，两个翼通过塑料或记忆材料绞链区520连接。绞链区520的材料形成为具有将翼516和518偏置为舒部署状态(如图34所示)的回弹性记忆。
每个紧固件508都被携带在凸缘区域506上的索眼510内(参见图35)。当绞链区520被限制在索眼510内(如图35所示)时，翼516和518逆着回弹性记忆以相邻的闭合状态保持。根据在头512上施加的推力或穿刺力(参见图35)，翼516和518以闭合状态被推进到索眼510的外侧，并且进入和穿过相邻的血管壁(参见图36)。随着继续的前进，绞链区520解除了索眼510的限制(参见图37)。结果，翼516和518回弹性地弹回到其正常的舒部署的状态。
在这种布置中，管腔内工具522(参见图33)部署到假体500中，用于对给定紧固件508的头512施加推力或穿刺力。在说明性的实施方案中，工具522包括在其远端携带冲压元件526的导管524。在所需的布置中，导管524的远端为可操纵的，以帮助建立冲压元件526与给定紧固件508的头512之间的点接触。头512可以包括凹口528，用于在使用过程中接受冲压元件526的末梢并使其相对于头512稳定(参见图34)。
在使用中，冲压元件526操作为用于对所选择的紧固件的头512施加推力或穿刺力。如图35和36所示，由冲压元件526施加的推力推动翼516和518对着血管壁34的内侧。翼516和518仍然处于其闭合状态，因为绞链区520仍然被限制在索眼510内。闭合的翼516和518在其前进到血管壁的远侧时形成穿透组织的密闭件。随着绞链区510脱离索眼510(图37)，翼516和518抵靠血管壁的远侧回弹到其舒部署的状态。在除去冲压元件526时(参见图38)，头512和舒部署的翼516和518保留为其在血管壁中互相相对的状态，以抵靠血管壁使假体500固定。在使用中，医生将冲压元件526连续地对着每个紧固件508定位并操作，以实现将假体500锚定到血管壁。
在一个实施方案中(参见图39)，每个紧固件508可以包括以松脱方式连接于头512的追踪线530。追踪线530从头512伸出到身体外，用于从血管外部进入血管。在这种布置中，冲压元件526包括腔，以适应追踪线530的通过。追踪线530在管腔内通道中引导冲压元件到达各个紧固件508。在操作冲压元件526以驱动紧固件508进入血管壁之后，冲压元件526可以沿着追踪线530撤回。追踪线530可以通过例如对线530施加中等拉力而从目前已被固定的头512上松脱。然后可撤回追踪线530。顺序地沿着另一个追踪线530引导冲压元件526，用于与另一个紧固件508相互作用，直到实现所需的锚定程度。
在替代性的实施方案中，可使用假体50上的一体化的紧固件组件502，用于在实现永久性锚定技术时临时钉住假体500在适当的位置。例如，在这种布置中，在使用一体化的紧固件组件502以临时保持假体500在所需位置之后，以前述方式部署单独的螺旋状紧固件28，以永久地抵靠血管壁锚定假体500。
应该理解，本文中所述的优选实施方案的组成和/或特征可一起使用或分别地使用，而所述方法和装置可整个或部分地进行合并或改进。考虑了引导部件的部件、紧固件施用器、和螺旋状紧固件可替代性地相对于彼此进行取向，例如偏置、双轴等等。另外，应该理解，有多种实施方案可用于本文中没有描述的另外的过程中，如血管创伤、动脉切开、人造心脏瓣膜连接和血管系统和通常身体内的其它假体器官装置的连接。
上面详细地描述了本发明的优选实施方案，以提供完整的公开和用于解释和阐明目的。本领域的技术人员可在本发明公开的范围和精神实质内想象到其它改进。

Claims (5)

1.系统，包括：
至少一个组织刺入紧固件，其具有用于刺入和穿透假体和组织的尖锐的远端末梢，和
紧固件连接组件，其尺寸适合于并构建为从远程进入位置部署到目标血管内区域，该紧固件连接组件包括，
管腔内引导部件，其限定了进入通道并包括管状体，该管状体具有柱强度和可偏转的远端区域，其中该管腔内引导部件不含稳固装置，和
管腔内紧固件施用器，其与管腔内引导部件分离并包括具有柱强度的心轴，该心轴尺寸适合于并构建为沿着进入通道引入，其中该管腔内紧固件施用器不含稳固装置并且还包括由心轴携带的致动件，该致动件选择性地进行操作以在植入力方向产生植入力，通过使尖锐的远端末梢刺入和穿透目标血管内区域中的组织而植入组织刺入紧固件，
其中管腔内引导部件的管状体和管腔内紧固件施用器的心轴之一或二者的柱强度足够分解目标血管内区域中的至少一部分的植入力。
2.权利要求1的系统，其中假体包括至少一个自膨胀支架。
3.权利要求1的系统，其中假体包括至少一个延展性支架。
4.权利要求1的系统，其中管腔内引导部件包括限定进入通道的通路。
5.权利要求4的系统，其中通路包括内腔。
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EP1675528A2 (en) 2006-07-05
US20040127916A1 (en) 2004-07-01
US20050256531A9 (en) 2005-11-17
CA2539585A1 (en) 2005-04-14
US20160007991A1 (en) 2016-01-14
US7491232B2 (en) 2009-02-17
AU2004277897B2 (en) 2011-07-07
CA2539585C (en) 2012-02-21
US20150327859A1 (en) 2015-11-19
CN1856280A (zh) 2006-11-01
AU2004277897A1 (en) 2005-04-14
WO2005032333A3 (en) 2006-04-20
JP4465359B2 (ja) 2010-05-19
EP1675528A4 (en) 2014-09-03
US20160058438A1 (en) 2016-03-03
WO2005032333A2 (en) 2005-04-14
US20070021753A1 (en) 2007-01-25
EP1675528B1 (en) 2016-11-09
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US9968353B2 (en) 2018-05-15
US20090082852A1 (en) 2009-03-26
US20160007996A1 (en) 2016-01-14
JP2009112827A (ja) 2009-05-28

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