CN102791205B - 栓塞装置 - Google Patents
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Abstract
这里介绍了栓塞植入件以及制造方法。植入件可以用于在血管内部位闭塞血液流动。一种用途是在颅内动脉瘤栓塞或闭塞中,另一用途是在载瘤血管闭塞(PVO)或牺牲中。各种结构用于改进用途(例如关于传送、重新捕获、可视和/或闭塞)和可制造。
Description
背景技术
共同受让的美国专利申请系列No.12/465,475(Becking等人,也为PCT/US2009/041313)介绍了一类新的、基于编织的栓塞装置和输送***界面。植入件可以用于在血管内部位闭塞血液流动。一种用途是在颅内动脉瘤栓塞或闭塞中,另一用途是在载瘤血管闭塞(PVO)或牺牲中。对这些装置的改进将在本文中介绍。
技术领域
形成有折叠和折平远端的编织球装置在Becking等人所述的结构中。这些结构是最适合治疗脑动脉瘤的结构。还介绍了远侧标记方法,它特别适用于这种装置。此外,介绍了近端精加工方法,它适用于在Becking等人所述的这些和其它装置。Becking等人(美国专利申请系列No.12/465,475和PCT/US2009/041313)提出的所有结构和技术都被本文参引。
发明内容
根据本发明,提供了一种栓塞装置,该栓塞装置包括本体,该本体具有近侧和远侧,一辐射不透过标记定位在所述本体内并且通过至少一个丝保持在所述远侧附近,
其中(i)所述至少一个丝从所述标记延伸,(ii)所述至少一个丝附接到所述本体的近侧,并且(iii)所述至少一个丝具有一定长度,所述长度容许所述至少一个丝在所述本体膨胀时松弛,并且当所述本体处于压缩结构中时使得所述标记与所述本体对准。
可选地,所述至少一个丝包括缝合材料,所述缝合材料被打结,以便固定所述标记的近侧。
可选地,所述至少一个丝包括金属材料丝带,所述金属材料丝带可焊接到所述本体,用于固定在所述本体的所述近侧处。
可选地,当所述本体无约束时,所述至少一个丝与所述本体的曲率大致匹配。
可选地,所述至少一个丝具有预置形状。
可选地,所述至少一个丝预先成形为在所述本体无约束时与所述本体的曲率大致匹配。
可选地,所述至少一个丝由不锈钢、钛、镍钛诺或铂构成。
可选地,所述本体包括编织材料,并且其中,(i)所述至少一个丝的近端被捕获在编织材料的层之间,或者(ii)所述装置还包括内部带或外部带且所述至少一个丝的近端被捕获在编织材料和所述装置的内部带或外部带之间。
可选地,所述本体包括编织材料,并且其中,(i)所述至少一个丝的近端被胶接在或通过焊接固定在编织材料的层之间,或者(ii)所述装置还包括内部带或外部带且所述至少一个丝的近端被胶接在或通过焊接固定在编织材料和所述装置的内部带或外部带之间。
可选地,所述至少一个丝的长度大致等于所述本体在压缩结构中时的长度,以便使得(i)在所述本体膨胀时,所述标记相对于所述本体的纵轴线不对准;(ii)当所述本体处于压缩结构中时,所述标记与所述本体的纵轴线对准。
可选地,在压缩结构中,所述至少一个丝固定地附接到栓塞装置的近端或远端。
对于远侧标记方法,一种改进包括用于包含在植入件中的远侧标记的系绳。具体地说,对于固定在植入件的远端附近的标记(如在包含的申请中的折平实施例),系绳/带延伸至植入件的近侧芯部(hub)。它的长度设置成这样,当植入件压缩时,标记拉动成与植入件和/或导管对准。
当缝合线用于系绳时,它能够在最小干涉的情况下环绕远侧折叠的内部系住。然而,由于其它原因,有利的是使用金属丝带(例如Pt或镍钛诺)。
即,系绳丝带(特别是当预先形成“V”形时)能够穿过间隙/孔并环绕编织件的至少一根线。当这样布置时,不会与植入件的远端压缩形式干涉。而且,在丝带(包括两种丝,或者在卷曲、胶接、焊接或以其它方式固定至少一个标记之后修整成一个)中的弹簧作用能够帮助在布置时将标记定位成抵靠/横过植入件的顶部。这样的丝带还能够有助于使得标记为辐射不可透过,从而能够有更小的标记尺寸。
另一选择是包括与系绳连接的纤维和/或其它栓塞促进材料。不管选择哪种材料和/或提供附加结构,系绳的近端被有利地捕获在编织件的层之间或者在编织件和任意一个可选的内部带或外部带之间。它可以胶接、通过焊接或以其它方式固定。
还一组改进涉及完成植入件的方式。“完成”的意思是管理植入件的近侧的方式,以便限定芯部和/或传送***脱开界面。
在一种有利的方法中,希望使用内部带来用于与脱开***部件(例如在参考申请中所述)交接,处理通过在编织件中的细长海波管设备来进行。海波管(例如大约2-5cm长)用作保持和操纵植入件预制品结构的装置。此外,当管被切断时(或当相对于被保持的管切断最终或接近最终的植入件时),在植入件内的、海波管的剩余部分(这时称为“内部带”)限定了脱开界面管腔。同样,特别是当更加辐射不透过的材料(例如Pt/Ir或者CoCr)用于该管时,相同结构将提高和/或提供在植入件的近端处的所需辐射不透过性。
总的来说,该方法(可选择的结构在于“牺牲海波管长度”方法)用于胶接,但是也可以用于焊接技术。实际上,通过提供防焊渣屏蔽,焊接技术在下面文本中可以特别有利,且近侧孔/口的变形将通过修整管而暴露,以便限定在植入件中的内部带。即,在焊接后,能够进行清洁切割(例如通过金刚石据、激光切割、EDM等,如上所述),然后能够根据需要而在新暴露的表面上(通过机械作用、蚀刻EP或其它方式)进行任何去毛刺。
与用于胶接的牺牲海波管长度方法或在参考申请中所述的原始胶接方法结合,通过不同的后处理步骤提供另外的有利选择。即,当在植入件的近端处使用外部带来限定用于粘接剂/胶水(例如Loctite4014)的外部浇注边界之后,它可以除去,从而使下面的胶水铸件就位。外部带的除去提供了降低植入件的近侧结构的高度、直径和外观尺寸的可能。因此,它可以帮助发展具有0.021"导管横向型面的***。
为了方便取出,带可以有利的是包括NiTi合金(它自然形成钝化层),或者它可以涂覆或以其它方式电镀。氮化钛涂层可以是希望的。喷射模具释放(例如3M)或在模具释放中的浸入涂覆可以选择性地用于在粘接剂施加和固化后帮助带的滑出。否则,带可能切断胶水铸件。
用于获得最小植入件芯部直径同时保持所需的辐射不透过性的另一方法包括将铂带固定在内部NiTi带的顶部上(即在线性结构中)。近侧/下部NiTi部分能够很容易焊接在球中的NiTi编织件(当这样构成时)上,且Pt(包括Pt/Ir和其它合金)提供了成直线的辐射不透过标记。脱开***的控制和锚固丝线通过两个带来接收。带可以进行附接(例如通过焊接、胶接或钎焊),或者只是彼此相连,直到除去脱开***丝线。在各种情况下,它们可以包括干涉配合、迷宫零件或其它槽或舌榫结构,以便形成或帮助形成在本体之间的连接。
另一组改进涉及使得“折平”型植入件的远端成形。它可以提供有平的顶部。平的顶部来自于在圆工具(编织件在该圆工具上成形)中形成的平部分。该平部分能够通过从型中磨削大约0.010"来产生。该深度的切割足以产生用于合适成形的“台板”,并能够横过尺寸在从大约5mm至12mm直径范围内的植入件一致地使用,且对觉察的形状几乎没有影响。在通过这样的型在成形的植入件丝线中形成的折痕提供了植入件布置的直接优点。通过使得平部分布置成靠近装置的远端,当脱鞘时,在平顶部周围的弯曲/折痕的形状恢复将很容易的驱动植入件打开(与当环绕平部分形成的折痕设置在更远处或者没有提供折痕时的情况相比)。
这里介绍的还一组植入件改进增大了球的密度。换句话说,提供了编织材料的附加层,以便进一步减小编织件基体的孔隙度,并能够在并不增加装置的横向型面/传送(微)导管相容性的情况下完成它。
这些改进涉及第三层编织件,该第三层编织件添加到优选地已经存在于折平基部植入件结构中的两层上。在一种变化形式中,第三层编织件捕获在两层之间并捕获在芯部区域内,但是在远侧折叠/平部分附近修整。在另一变化形式中,内层设置在前述两层的封套内。有利地,它附接在内部标记带的远端(上面/远侧)、附接在提供的任何外部标记带。因此,编织件的附接将不会增加芯部型面。为了避免在植入件远端处的任何型面增加,内层通常将进行修整,使得在压缩时它的压缩长度位于在植入件远端处的折叠编织件附近。在未受限制的形式中,内层可以简单地限定环。可替换地,它可以限定第二球形。这样的球形可以为基本球形或椭球形。一种有利的结构还包括编织件的无末端接头的远端。限定内部球的编织件端部可以固定在带中或焊接在一起。这样构成后,它们能够在球内提供另一辐射不透过标记结构。然而,优选是内层(成杯形、球形或其它形状)的编织端部是无末端接头。因此,它们可以提高在植入件的本体内的栓塞形成。
最后,介绍传送***的改进。所述结构进行“改进”,与上面所述结构相同。例如,某些传送***结构可以并不像其它的结构那样有空间效率。还有,为了减小制造的复杂性和/或成本,可以希望更大的***。
植入件、传送***、包括它们的工具包、使用方法以及制造都包含在本发明的范围内。上面介绍了这些制造的多个方面。下面将结合附图更详细地说明。
附图说明
这里提供的附图并不需要按比例画图,且一些部件和结构为了清楚而扩大。可以考虑图示实施例的变化形式。因此,在附图中的实施例的多个方面和元件的介绍并不用于限制本发明的范围。
在附图中,图1A和1B分别表示在膨胀和压缩时的具有标记系绳的植入件;图2A和2B分别表示另一系绳-标记实施例的远端视图和侧视图;图3是标记/系绳子组件的详细视图;图4示意表示了图3中的组件,该组件设置在植入件中;图5表示了准备用于近端精加工的植入件预制品;图6表示了焊接的近端;图7表示了根据另一方法准备用于近端精加工的植入件预制品;图8表示了切割和焊接的近端;图9A和9B表示了使用可替换的近端精加工方法的植入件,其中图9B中详细表示了低型面实施例;图10A和10B表示了可以用于多种端部精加工方法的另外的近端辐射不可透过结构;图11表示了形成有远侧平顶部的植入件;图12表示了用于横过给定尺寸范围的多个不同植入件施加如图11中所示的植入件形状的植入件形式;图13A和13B分别表示了根据图11/12形成的植入件的操作(用于并不是这样的植入件相比);图14-17示意表示了改进密度的植入件(与在图4中的结构相比);图18表示了可以与本发明结合使用的植入件/脱开***界面的概括图;图19A-19E和20A-20E表示了图18中所示的***的操作阶段(分别是手柄侧和植入件侧);图21表示了对相同***的结构的可选改进;图22A和22B分别表示了接合和脱开的可替换传送***界面;图23是如图22B中所示的传送***界面的端视图。图24A和24B表示了在相同***中的推进器轴的结构的可替换端视图;图25A和25B表示了基于图24B中的推进器轴结构的、可替换的传送***界面选择(分别是接合和脱开);图26表示了具有如图25A和25B中所示的传送***的可替换植入件侧界面;图27表示了与图26中所示植入件侧界面类似的植入件侧界面,它具有可替换的推进器侧结构;图28A和28B表示了用于与图22A中所示***类似的***的可替换接合/脱开界面;图29和30分别表示了用于各编织类型植入件和栓塞线圈的还一接合/脱开结构。
具体实施方式
下面将介绍各种示例实施例。这些实例为非限定的,应当知道,它们用于示例说明装置、***和方法的更广义应用方面。在不脱离本发明的真正精神和范围的情况下,这些实施例可以进行多种变化,且可以由等效物代替。此外,可以进行多种变化,以便适应特殊的情况、材料、物质组分、处理、处理动作或步骤来适应本发明的目的、精神或范围。所有这些变化都将在权利要求的范围内。
对于在概述或详细说明中介绍的任何尺寸,它们将只是实例,并不是限制本发明主题,除非在权利要求中提出。
而且,这里所述的实施例的多种结构将彼此补充,而不是纯粹交替,除非这样说明。换句话说,来自一个实施例的结构可以与其它实施例的结构自由地组合,如本领域普通技术人员很容易知道,除非说明这些结构只用于替换。因此,当由概述、详细说明和权利要求不容易清楚时,申请人在这一段中将提供对于任何目前或将来的权利要求(该权利要求列举从不同实施例中获取的结构)的书面支承。
参考附图,图1A和1B表示了植入件10。在图1A中,只有植入件10的芯部(不可见)接收于鞘或导管2中。在图1B中,大致40%的植入件10接收于鞘2中。在两个图中都可以看见辐射不透过的标记20(例如Pt带)。与Becking等人中的相同,并且继续参考图4,植入件10包括系带22,该系带位于编织层12和14之间并邻近编织件中的远侧折叠16,它限定了孔18(这里也称为在编织件中的孔或间隙)。标记20由系绳22保持。系绳22还可以帮助关闭或限制孔18可以打开的尺寸。
尽管在Becking等人中系绳22终止于标记20附近,但是在本说明书中它延伸至植入件10的近侧芯部30。这样提供的延伸“系绳”部分或部件24操作成当植入件10捕获在(特别是当重新捕获在)导管/鞘中时保证标记20的轴向对准。
系绳部件24的长度因此设置成这样,当植入件膨胀(如图1A中所示)时有松弛,而当植入件完全压缩或将完全压缩时,该松弛被除去(如图1B中所示)。
图1A和1B中所示的系带和/或系绳部件通常由缝合材料来制造,它可以由任何其它可生物相容材料来制造,包括不锈钢、钛、镍钛诺(可以是丝线,它在体温下为马氏体-通常称为“肌肉丝线”)等。当使用缝合材料时,它能够以最小干涉而环绕远侧折叠16的内部系住,并在点26处形成结(见图1A),以便容易固定标记20的位置。相同方法可以通过细线(例如0.001英寸的圆丝线)来实现。
由于其它原因,它实际上可以有利地使用金属丝带(例如Pt或镍钛诺)。在下面的图中详细表示的结构使用尺寸设置为大约0.001英寸乘大约0.003英寸的超弹性NiTi丝带。
热固化成紧环或“V”形的系绳丝带22穿过间隙20,并在植入件10的远端处环绕编织件的至少一个丝线,如图4中所示。这样布置后,系绳丝带22基本并不干扰植入件的远端的压缩。而且,在系绳丝带中的弹簧作用(在卷曲、胶接、焊接或以其它方式固定标记20之后包括两种丝或修整成恰好一个丝(如虚线所示),如图3中所示)能够帮助将标记20定位成抵靠(或横过)植入件10的顶部(当布置时),如图2A和2B中所示。对于固定标记,应当知道,成对的丝带段(一个堆置在另一个之上)提供了良好的界面,标记20卷曲在该界面上,而并不明显改变标记的形状。
还有,系绳的长度可以选择地设置成大致“?”形,以便无约束时(例如如图4中所示的系绳)与植入件的曲率匹配(或者更紧密匹配)。使得系绳预先成形为“匹配”(或者近似匹配)一个或多个植入件尺寸能够帮助保证在不同植入件尺寸和压缩的范围内有可预测和类似的植入件性能。
如上所述,目标植入件的另一改进涉及近端精加工方式。图5表示了准备近端精加工的植入件预制品60。这里,植入件预制品60(例如在Becking等人中制备的)被制备,从而留下延伸经过近侧标记带32的附加突出段50。在很多方面,设备类似于在Becking等人的图13A中所示,其中,植入件预制品60包括内部NiTi管34和在心轴52上的装配组。为了保持所示部件的位置,施加胶水(例如Loctite4014)。即使这样,还参考图6,芯部区域30能够与包括突出编织件50的焊道54、内部管34有效焊接,并且至少点焊外部Pt带32。应当注意,通过(或进入)胶接稳定编织件获得这样接近最佳的焊接结果是令人惊讶的结果。换句话说,它是焊接(激光焊或其它方式)领域的技术人员不可预计或不可预期的。在任何情况下,包含在焊缝54中的编织件突出部长度可以根据多种因素而变化,包括植入件直径、丝线直径、编织件密度等。如图所示,突出部的长度为大约0.005至大约0.010英寸。
下面将结合图7介绍另一近端精加工方法。具体地说,预制品62并不为了焊接而进行修整和稳定,如图5中所示。而是,预制品62制备在细长海波管54上。海波管本体提供了保持该结构以及使得它的编织层12和/或层14的细长“尾部”段56稳定在其上(例如通过包套58)的装置。
通过限定的狭窄窗口(例如优选是大约0.010至大约0.025英寸的暴露编织件),激光能量施加,如更大区域所示。该能量足以将编织件焊接到海波管。然而,焊接处理并不将海波管焊接到可选的底部心轴52。
在这样焊接之后,海波管54的大部分长度“牺牲”。它被切断,以便限定植入件的内部带34,如图8中所示。该内部带可以提供在芯部区域30中所需的一些或全部辐射不透过性。然而,外部带(特别是当它包括Pt时)能够点焊在编织件上,如图7中的箭头Z所示。
无论是否包括外部标记带,图8表示了精加工方法的优点,即避免了与在本体的端部处的表面拉伸相关联的焊道流动假想(也见图6)。而是,焊缝64纯粹有覆面,并且剩余带34的内部管腔被去毛刺和/或进行绞孔。因此,实际和表观芯部尺寸能够最小。
图9A和9B表示了用于使近侧芯部尺寸最小的另一有利的近端精加工方法。图9A表示了具有外部标记带32的植入件在它大致表现为通过胶接或焊接而固定时。在该带通过胶接而固定的实例中,一旦在其中形成胶脱落件,带就能够取下。然后,植入件10'将包括近侧芯部30',该近侧芯部的直径减小(根据带厚度,减小大约0.004英寸),还通过提供更少对比而更少引人注意。在本体的外部(例如在包装中),医师将看见粘接剂/胶70的色泽或光泽(作为脱落件72),其中编织件代替高对比标记32被嵌入。
尽管看起来对于功能并不重要,但是这实际上能够与视觉方面相关。医师关于近侧结构块的印象能够影响医师是否采用产品。普通的植入件已经设计成具有完全***植入件的内部容积内的近侧芯部。这确实使得植入件的外观更吸引医师。然而,植入件因此性能受损(例如,植入件更难取回;对植入件的丝线尺寸和强度的要求变高,以迫使植入件恢复***形状,从而导致植入件的尺寸不希望地增加;以及其它性能缺陷)。在本发明方面中,可觉察的芯部尺寸减小,这增加了视觉吸引力,而并不损害性能。
图10A和10B表示了另外的实施例,它省略了外部带,同时特殊提供了相对增加的辐射不透过性。具体地说,通过将辐射不透过的带结构重新设置为与内部带34成直线结构,能够实现最小植入件的芯部尺寸。简单的Pt带74能够设置在内部带34的顶部上,如图10A中所示。这些部件可以使用普通技术来连接(即胶接、钎焊、焊接等),或者通过利用传送***界面部件来暂时保持相互关系,如图18等中所示,图10B的实施例通过使用锁76和键78结构而使得部件34和74互锁。
另一植入件结构结合图11和12表示。植入件可选地包括远侧孔18附近的平顶部80。该平顶部通过在用于限定植入件的整体形状的模制元件88中提供台板表面82来制备。图12中表示了不同尺寸的模制元件或型88、88'和88"。它们从球形形状进行磨削,以便使由边缘84包围的平部分82。边缘产生了在编织丝线中的折痕86。应当知道,平部分80和折痕86在图2A和2B中的交替视图中表示。
在植入件预制品热固过程中,已经发现平部分提高了在植入件中的远侧折叠16的质量,从而有助于使均匀性最大并使丝线中的弯曲半径最小。因此,装置在导管内通过曲折解剖结构的跟踪能力也提高。平区域设置在植入件中的边缘处的折痕也有助于在布置时的传送性能。具体地说,如图13A中所示,折痕86表示在形成植入件编织基体的丝线中的多个弯头。当从微导管离开时,弯头恢复,并使得植入件远端打开超过植入件,而没有这样的折痕,如图13B中所示(也见图1B中的植入件)。作为更加打开的本体,植入件更柔软,它将以更松弛的编织角度来接触任何脆弱组织-例如动脉瘤的圆顶。
可以用于植入件的其它结构变化或增加在如图14-17中所示。各方法提供了相对于图4中所示的亲代结构大概提高密度的可能性。
具体地说,植入件90包括设置在外层12和内层14之间的中间编织层92。层92捕获在芯部30中,在近侧附件94处的其它层也被捕获在芯部中。远侧延伸部分96能够设置在多个位置。有利地,它延伸至装置的中间点或赤道周围。这样,层将有助于植入件密度(或者换句话说,降低孔隙度),甚至用于宽颈动脉瘤。
如图14中所示,编织件的远侧延伸部分96邻近植入件的折叠段16。这里,密度最高,因此内层丝线将保持最佳地捕获在层12和14之间。还有,因为端部96并不与折叠16(该折叠能够是植入件的最高型面方面)干涉,导致横向型面几乎不或不需要增加。
在制造中,植入件的内层92能够通过在远侧折叠的一半中切割预制品(类似于预制品62)来简单制造。这制造了一组两个内层部分,它们能够用于由单个形成步骤产生两个不同装置。然而,在制造后,因为内层可以依靠在其它层上用于结构限定,因此它能够由比其它层更细的丝线和/或有更低的编织线数制造。例如,内层可以包括72端0.0008英寸丝线编织件,而外层包括96端0.0008英寸丝线编织件。然而,它们可以被相反设置,其中,内层更坚固。在任何情况下,有利地使得包含在编织件中的丝线端的数目错配(例如在上面直接的实例中),以便帮助避免丝线相配,从而使孔隙度最小。
图15中表示的植入件100表示了用于提高流动中断效果的另一有利方法,而并不增加装置的横向型面。与装置90中相同,使用中间编织层90。然而,它的近端并不固定在芯部内,因此容易在该区域中进行空间限制。
实际上,通过使得编织层涂覆有聚合物(例如Lubrizol,Inc.的TICOPHILIC涂层)或者其它涂层或处理来保持编织件基体的完整性。水凝胶涂层也提供了有吸引力的选择,例如基于水凝胶的聚合物网络,它能够捕获药剂,如Won等的USPN6,905,700中所述。同样,当植入件元件有利地包括镍钛诺编织件(通常为超弹性NiTi)时,用于任何层的编织件可以实际上包括聚合物-特别是高强度可生物降解聚合物,例如MX-2(MAX-Prene)、合成可吸收单丝(90/10乙交酯/L-丙交酯)和/或G-2(Glycoprene)、合成可吸收单丝(乙交酯(PGA),ε-已内酯(PCL),三甲撑碳酸盐(TMC)共聚物),它热固成形(例如在110摄氏度下持续1小时)和/或涂覆有相同物质,以便如上述稳定编织件基体。
图16中所示的植入件110提供了用于提高栓塞(或流动中断)效果的还一方法,且对横向型面几乎没有或没有影响。这种效果通过将最内侧/第三编织层112在它的近端114处固定在内部带34上而实现。它可以焊接、胶接、钎焊或以其它方式固定于其上。编织件116的远端可以如图所示或以其它方式修整和成形。例如,这样形成的杯可以紧密地沿着装置的内周,直到或经过它的赤道。
与前面附图中的变化形式相同,包含在植入件中的第三层简单地布置,并与植入件的其余部分共同重新捕获。然而,图16的结构的特点是编织件的近端114稳定地固定,但是它固定成并不需要在芯部中的空间(例如在外部标记带32中),而没有尺寸积累。
相关植入件结构在图17中表示。这里,在植入件120中,使用相同近端114附接方法。还有,不是使得编织件的内层形成杯形(例如通过热固),而是形成内部球118。球的近侧提高了总体的近侧植入件密度,还限定了在植入件内的分开的流动停滞区域A和B,以便进一步帮助在植入件内形成血栓。
内部球本体118可以在型上面成形。可替换地且有利地,可以在没有外部或内部型的情况下通过将编织件聚成团和将它系在心轴上用于热固而形成形状。这样的“自由形成”方法在功能上很有利,因为它使得最终本体中的编织角度(因此,密度)最大。还有,假定只有由编织层12和14限定的植入件的外部体接触动脉瘤,那么任何形成的形状不一致性都可控制。
不管它怎样形成(和特殊编织件结构怎样选择),在结构中的内部球118将设置成当装置被压缩以便传送或重新捕获时,使得它不会与植入件本体/壳的远端和/或标记和系绳干涉。
更通常是,图18提供了治疗***200的植入件侧的总体视图。***包括植入件10(90、100、110、120)和推进器/导管轴210,该推进器/导管轴210最终附接在手柄220上(例如如图19A-19E中所示)。它们中的任意一个都可以根据本文和/或参引文献的教导来构成。
一个手柄的结构包括单个柱塞。该柱塞拉动轴环,该轴环与连接到丝线的凹窝逐渐接合并拉动该凹窝;各控制丝线212首先被拉动(一次一个),然后拉动锚固丝线214。这样的动作在图19A-19E和20A-20E中表示。图19A和20A表示了在从包装中取出时的装置部件。图19B表示了通过相对于手柄本体224旋转120度而脱开手柄柱塞222。这样的动作对图20B中所示的脱开界面216没有效果。然而,图19C-19E中柱塞的逐渐拉动使得***释放,如图20C-20E中所示。
图21表示了对***200的结构的选择改进。这里,***200'只有一个“真正”的控制丝线212,该控制丝线接收于植入件10的芯部或内部带30/34中。即使这样,植入件仍然通过控制丝线与锚固球216(例如通过激光形成或以其它方式设置)的相互作用而牢固/稳定地附接到导管轴。
植入件的释放将从图19C和20C前进至19E和20E的步骤而实现。然而,第三(浮动或驱动)“仿真”丝线218还装入推进器轴210的管腔中。使用该丝线将保持丝线在轴210内部的封闭包装结构,这可能对于限定丝线在曲折设备中的位置很重要。还有,释放角度可以增加,柱塞拉力减小,因为在植入件内的丝线在它们之间具有更多空间,从而允许空间适应。
应当知道,长度“L”(丝线218***推进器轴内的该长度“L”)可以根据用途而变化。它可以并不***(即基本抵靠植入件近端)。它可以***大约1mm,这样,在曲折设备中的任何向前运动都不会导致与植入件接触。或者它可以***更大程度(例如在大约1cm和5cm之间),以便提高传送推进器轴210的远侧尖端的柔性。
图22A和22B分别表示了在接合和脱开状态中的可替换传送***界面。这里,***230包括借助于普通扭矩装置234来驱动的导管/推进器轴232。扭矩装置234锁定中心丝线236的位置,该中心丝线包括锚固球,用于植入件10的传送。缓冲器或凸肩240可以固定在导管上(也可选择,Pt带也用作标记),以便抵靠植入件的芯部30用于推动。
在植入件和推进器轴之间通过延伸部分242来实现接合,当锚固球238处于退回位置时,如图22A中所示,该延伸部分偏离为与植入件的内部带34成干涉关系。当丝线236(和推动末端球结构238)前进时,如图22B中所示,延伸部分232***(例如通过弹性作用或通过导管轴的退回而返回至它的初始位置),并滑出植入件。
图23是如图22B中所示的传送***界面的端视图。如图所示,一旦丝线236前进,在球238和/或延伸部分之间保持无干涉。图24A描绘了类似视图,但是丝线没有就位。它表示了延伸段242和导管本体232。当它们表示为以一种方式形成时(即通过90度切断),应当知道,延伸部分实际上可以通过角度切割或以其它方式形成。实际上,图24B表示了形成延伸部分的一种方法,即通过在一侧推倒导管壁以便与另一侧相遇,并选择地将部件部分242和242'热固、熔合或胶接在一起。
图25A和25B表示了基于图24B中的推进器轴延伸部分结构的可替换传送***界面250(分别为接合和脱开)。由于由双层壁产生的增加壁厚,***能够比图22A和22B中所示更多地工作,除了不需要远侧界面结构(即锚固球/带)。因此,丝线236的退回将释放干涉并脱开推进器轴232(特别是相关延伸部分),用于从植入件10中退回。
图26表示了可替换的植入件侧界面,具有如图25A和25B中表示的传送***。这里,提供了植入件凹窝260。凹窝260可以由杯262和渐缩管264来限定,该杯262通过焊接或以其它方式附接在一个或多个植入件编织层(12、14)上,该渐缩管264螺纹连接、按压或者以其它方式固定在杯的近端中。应当知道,通过这样的结构,可以在没有凸肩或其它近侧界面的情况下完成植入件推动。实际上,推力和拉力(用于退回)的施加能够在凹窝腔室内产生。尽管这样的凹窝通常大于前面所示的界面,但是它容易改型,或者用作螺钉型释放方法的可替换方式,该螺钉型释放方法用于很多容器牺牲和封闭装置中,如AGAMedical,Inc.和其它公司出售。
在图27中的传送***结构表示了相同的植入件侧界面260,具有可替换的推进器侧接合/脱开(或闩锁)结构270。该结构是Becking等人的图18中所示的简化形式。具体地说,推进器轴272(例如金属海波管)提供有单个窗口切口274。该窗口(设置为正方形切口、圆形或简单的截口)允许芯部件276(例如NiTi丝带)穿过,并提供了对推进器轴远侧面276的干涉,以便防止传送***脱开,直到芯部件退回。
图28A和28B表示了用于与图22A和22B所示***类似的***的可替换闩锁界面280。在该***中,弯回丝线钩282起到前述***中的球的作用。这样的***提供了非常低制造成本的优点以及可靠的锚固结构。图29表示了***290,该***与图21中的***最接近相关,除了多个控制和/或仿真丝线由单个丝带292来代替。
最后,图30表示了脱开***300。与***290中相同,丝带292可以与具有球形锚固件216的圆锚固丝线214结合使用。可以在各***中使用的可选方法将使用丝带作为“锚固丝线”,并通过在其中系绳结而在它的端部处形成干涉结构(作为激光形成的球的替代品)。这样的绳结能够进行形状固定、胶接或焊接,以便稳定它的形状。它能够可靠地以低成本以非常小的尺寸制造在丝带上。凹窝型界面能够通过将轴环结构302装配至线圈的近端中而形成于线圈内。轴环可以螺纹拧入(即拧入类似螺纹节距的线圈中)。一种可选方法包括使得钎料流入线圈之间,并利用可取出的心轴来限定其中的管腔。心轴可以以任意方式来制造,以便于它的取出,包括结合图9B介绍的改进形式中那些用于可取出的芯部。
在各种传送***结构中,导管/推进器轴包括简单挤出(例如PTFE、FEP、PEEK等),或者可以使用普通的导管构造技术来构成,包括衬垫、编织支承件和外套(未示出)。示例结构可通过MicroLumen,Inc.获得,作为编织增强聚酰亚胺。聚酰亚胺的远侧部分可以熔化,并由熔化的Pebax代替,以便向导管提供更软或逐渐柔性的端部。装载鞘通常布置在推进器轴上面。有利地,装载鞘可劈开。
当并不预装载时,在从无菌包装(未示出)中取出之后,植入件拉入装载鞘中。装载鞘接收在用于植入件传送的导管的芯部内,且植入件前进至导管中。然后,植入件可以前进和布置在治疗部位。或者它可以退回以交换成另一尺寸的植入件-在最终脱开之前,在需要时也重新定位,如在此引用的应用主题中所述。
在本发明中,方法主题可以包括与植入件的定位和释放相关联的各个医师动作。因此,方法表示了本发明的植入件装置形式部件的定位和布置。该方法可以包括将植入件布置在脑动脉瘤中,或者在用于阻塞目标的亲代血管中,或者其它用途。在一些方法中,考虑了植入件影响动脉瘤或亲代血管的多个动作。
更特别是,根据本发明的多个方法涉及例如传送***在到达治疗部位时操作的方式。其它方法涉及***准备传送植入件的方式,例如将编织球附接到传送***上。这里的任何方法都可以使得所述事件以逻辑上可能的任意顺序、以及以所述事件顺序、或者这些事件或事件顺序的稍微变化形式来进行。
应当知道,所述的本发明变化形式的任何可选结构都可以独立地提出和要求,或者与这里所述的任何一个或多个结构组合。涉及的单数项包括有多个相同项。更具体地说,这里和附加权利要求中使用的单数形式“一”、“所述”和“该”包括复数的对象,除非另外明确说明。换句话说,物品的使用能够在上述说明书以及后面的权利要求中用于“至少一个”目标项。还应当知道,权利要求可以描述为排除任何可选元件。因此,这样的陈述将基于结合所要求的元件使用排他术语例如“单独”、“只有”等,或者使用“否定”限制。
当并不使用这些排他术语时,在权利要求中的术语“包括”将能够包括任意附加元件,而不管是在权利要求中列举了给定数目的元件还是附加结构可能认为改变在权利要求中凸出的元件的性质。除了在这里特别定义,否则这里使用的所有技术和科学术语都在保持权利要求有效时给出尽可能广义的普通理解意思。
本发明的范围并不局限于所提出的实例和/或说明书,而是只由权利要求的范围来限定。这里使用的术语“发明”并不是限制权利要求的范围。应当知道,“发明”包括这里明确说明或暗示的很多变化形式,包括本领域技术人员通过阅读本说明书将显然知道的这些变化形式。而且,本说明书的任何部分(例如概述、详细说明、摘要、发明领域等)都不必根据关于其它部分或权利要求在介绍本发明是的特别说明。所引用的参考文献都整个被本文参引。尽管前面已经为了清楚理解而详细介绍了本发明,但是应当知道,在附加权利要求的范围内可以进行某些变化。
Claims (11)
1.一种栓塞装置,该栓塞装置包括本体,该本体具有近侧和远侧,一辐射不透过标记定位在所述本体内并且通过至少一个丝保持在所述远侧附近,
其中(i)所述至少一个丝从所述标记延伸,(ii)所述至少一个丝附接到所述本体的近侧,并且(iii)所述至少一个丝具有一定长度,所述长度容许所述至少一个丝在所述本体膨胀时松弛,并且当所述本体处于压缩结构中时使得所述标记与所述本体对准。
2.根据权利要求1所述的栓塞装置,其中:所述至少一个丝包括缝合材料,所述缝合材料被打结,以便固定所述标记的近侧。
3.根据权利要求1所述的栓塞装置,其中:所述至少一个丝包括金属材料丝带,所述金属材料丝带可焊接到所述本体,用于固定在所述本体的所述近侧处。
4.根据权利要求1所述的栓塞装置,其中:当所述本体无约束时,所述至少一个丝与所述本体的曲率大致匹配。
5.根据权利要求1所述的栓塞装置,其中:所述至少一个丝具有预置形状。
6.根据权利要求5所述的栓塞装置,其中:所述至少一个丝预先成形为在所述本体无约束时与所述本体的曲率大致匹配。
7.根据权利要求1所述的栓塞装置,其中:所述至少一个丝由不锈钢、钛、镍钛诺或铂构成。
8.根据权利要求1所述的栓塞装置,其中:所述本体包括编织材料,并且其中,(i)所述至少一个丝的近端被捕获在编织材料的层之间,或者(ii)所述装置还包括内部带或外部带且所述至少一个丝的近端被捕获在编织材料和所述装置的内部带或外部带之间。
9.根据权利要求1所述的栓塞装置,其中:所述本体包括编织材料,并且其中,(i)所述至少一个丝的近端被胶接在或通过焊接固定在编织材料的层之间,或者(ii)所述装置还包括内部带或外部带且所述至少一个丝的近端被胶接在或通过焊接固定在编织材料和所述装置的内部带或外部带之间。
10.根据权利要求1所述的栓塞装置,其中:所述至少一个丝的长度大致等于所述本体在压缩结构中时的长度,以便使得(i)在所述本体膨胀时,所述标记相对于所述本体的纵轴线不对准;(ii)当所述本体处于压缩结构中时,所述标记与所述本体的纵轴线对准。
11.根据权利要求1所述的栓塞装置,其中:在压缩结构中,所述至少一个丝固定地附接到栓塞装置的近端或远端。
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- 2010-11-09 JP JP2012538088A patent/JP5711251B2/ja active Active
- 2010-11-09 EP EP10785550.4A patent/EP2498691B1/en active Active
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CN102791205A (zh) | 2012-11-21 |
CA2779483A1 (en) | 2011-05-12 |
EP2498691B1 (en) | 2015-01-07 |
CA2779483C (en) | 2018-03-13 |
US20110202085A1 (en) | 2011-08-18 |
JP2013509972A (ja) | 2013-03-21 |
ES2534192T3 (es) | 2015-04-20 |
US20110319926A1 (en) | 2011-12-29 |
JP5711251B2 (ja) | 2015-04-30 |
WO2011057277A2 (en) | 2011-05-12 |
EP2498691A2 (en) | 2012-09-19 |
WO2011057277A3 (en) | 2011-07-28 |
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