CN106539605A - 植入物和操作植入物组件的方法 - Google Patents
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Abstract
一种植入物,可包括框架和耦接至所述框架的网状部件。所述网状部件可界定第一孔隙度,并且所述框架可界定框架孔隙度。所述网状部件和所述框架的组合孔隙度可限制进入所述植入物的血流。以及一种操作植入物组件的方法。
Description
背景
发明领域
本公开整体涉及囊内(intrasaccular)医疗装置,并且更具体地涉及一种用于闭塞患者脉管系统的目标区域的具有框架和网状部件医疗植入物。
相关领域描述
脉管系统的壁,特别是动脉壁,可能形成称为动脉瘤的病理性扩张的区域。如熟知的,动脉瘤具有易于破裂的薄且脆弱的壁。动脉瘤可能是血管壁被疾病、损伤或先天性畸形弱化的结果。动脉瘤可存在于人体内的不同部位,最常见的是腹主动脉瘤(AAA)和脑动脉瘤。当动脉瘤的被弱化的壁破裂时可导致死亡。
动脉瘤通常通过将血管的弱化部分从动脉循环中排除来治疗。对于治疗大脑动脉瘤,以包括下列在内的许多方式进行此类增强:(i)手术夹闭,其中金属夹被固定在动脉瘤的基部周围;(ii)用小的柔性线圈(微线圈)或编织球装置来填塞动脉瘤;(iii)利用栓塞材料来“填充”或“填塞”动脉瘤;(iv)利用可拆卸球囊或线圈来闭塞供给动脉瘤的载瘤血管(parent vessel);以及(v)利用支架使血流转向而远离动脉瘤。
概述
本主题技术的另外特征和优点将在下文的描述中阐述,并部分地将通过该描述显而易见,或可通过本主题技术的实践而得以了解。通过尤其是在书面说明及其实施方案以及附图中指出的结构,将实现和获得本主题技术的优点。
用于治疗动脉瘤的系统和程序可包括可植入装置,所述可植入装置可插入动脉瘤中以促进血栓形成的愈合效应。所述可植入装置可具有特定的特性,包括孔隙度、组成、材料、形状、尺寸、连通度、相互接合性、涂层等。这些特性可经选择以实现所需治疗或可植入装置的放置。
用于闭塞患者脉管系统的目标区域(例如动脉瘤)的植入物或可植入装置可包括框架或框架部件和一个或多个网状部件,所述网状部件耦接至所述框架。所述可植入装置可被配置成提供无创伤高表面积区,所述区可在可植入装置植入体腔中时促进内皮化。可使用沿着框架的给定区布置的网状部件形成高表面积覆盖。在一些实施方案中,单个网状部件可耦接至具有大致恒定孔隙度的框架。然而,单个网状部件可具有可变孔隙度。另外,各自具有不同孔隙度的多个网状部件可耦接至框架。
在一些实施方案中,可植入装置可具有从装置的第一端部或区至装置的第二端部或区变化的平均孔隙度。由于给定区中存在一个或多个网状部件或基于框架本身在给定区中的孔隙度,装置的不同区可界定不同的孔隙度。一些实施方案因此提供一种可植入装置,所述可植入装置基于装置的近侧区中存在网状部件而可在远侧区具有第一孔隙度并且在近侧区具有第二孔隙度。
本主题技术例如根据下文所述的各个方面进行描述。本主题技术的多个方面的各个实例为方便起见以带编号的实施方案(1、2、3等)进行描述。这些作为实例示出而不限制本主题技术。应当注意的是,任何从属实施方案可与彼此或与一个或多个其它独立实施方案以任何组合方式进行组合,以形成独立实施方案。其它实施方案可以按类似的方式展示。以下是本文展示的一些实施方案的非限制性概述:
条目1.一种用于闭塞患者的脉管系统的目标区域的植入物,所述植入物包括:框架,其包括界定多个开口的多根编织长丝,所述多根长丝和所述多个开口共同界定框架孔隙度,所述框架包括远侧区和近侧区,所述框架能够从压缩构型膨胀至膨胀构型;和网状部件,其沿着所述框架的至少近侧区耦接至所述框架,所述网状部件包括多根长丝和多个开口,所述多根长丝和所述多个开口共同界定允许血流流经的第一孔隙度,所述第一孔隙度小于所述框架孔隙度,使得进入所述植入物的血流沿着所述框架的所述近侧区比沿着所述框架的所述远侧区更受限制。
条目2.如条目1所述的植入物,其中所述网状部件为第一网状部件,并且所述植入物还包括沿着所述近侧区耦接至所述框架的第二网状部件。
条目3.如条目2所述的植入物,其中所述第二网状部件包含与所述第一孔隙度不同的第二孔隙度。
条目4.如条目2-3中任一项所述的植入物,其中第一网状部件和第二网状部件覆盖所述框架中的各自的第一开口和第二开口,所述第一开口邻近所述第二开口。
条目5.如条目2-4中任一项所述的植入物,其中所述第二网状部件邻近所述第一网状部件布置。
条目6.如条目2-5中任一项所述的植入物,其中所述第二网状部件的边缘邻接所述第一网状部件的边缘。
条目7.如条目2-6中任一项所述的植入物,其还包括沿着所述近侧区耦接至所述框架的第三网状部件。
条目8.如条目7所述的植入物,其中所述第三网状部件邻近所述第一网状部件布置。
条目9.如条目7-8中任一项所述的植入物,其中所述第三网状部件包含与所述第一孔隙度不同的第三孔隙度。
条目10.如条目7-9中任一项所述的植入物,其中所述第二网状部件包含第二孔隙度,并且所述第三网状部件包含与所述第二孔隙度不同的第三孔隙度。
条目11.如条目10所述的植入物,其中所述第一孔隙度不同于所述第二孔隙度和所述第三孔隙度。
条目12.如条目1-11中任一项所述的植入物,其中所述网状部件包含材料条带。
条目13.如条目1-12中任一项所述的植入物,其中所述框架包含球状形状。
条目14.如条目13所述的植入物,其中所述框架包含球形形状。
条目15.如条目13-14中任一项所述的植入物,其中所述框架包括圆化的第一部分和大致圆柱形的第二部分。
条目16.如条目1-15中任一项所述的植入物,其中所述网状部件在多个耦接点处固定耦接至所述框架。
条目17.如条目16所述的植入物,其中所述网状部件在所述多个耦接点处焊接至所述框架。
条目18.如条目1-17中任一项所述的植入物,其中所述网状部件包含编织材料。
条目19.如条目1-18中任一项所述的植入物,其中所述网状部件沿着所述框架的外部布置。
条目20.如条目1-19中任一项所述的植入物,其中所述框架和所述网状部件层合在一起。
条目21.一种用于闭塞患者脉管系统的目标区域的植入物,所述植入物包括:编织框架,其包括彼此相交以界定开口的长丝,所述长丝和所述开口共同界定框架孔隙度,所述框架能够从压缩构型膨胀至膨胀构型;和网状部件,其耦接至所述框架,所述网状部件包括共同界定允许血流流经的第一孔隙度的长丝和开口,所述第一孔隙度小于所述框架孔隙度,用于限制进入所述植入物的血流。
条目22.如条目21所述的植入物,其中所述网状部件为第一网状部件,并且所述植入物还包括耦接至所述框架的第二网状部件。
条目23.如条目22所述的植入物,其中所述第二网状部件包含与所述第一孔隙度不同的第二孔隙度。
条目24.如条目22-23中任一项所述的植入物,其中第一网状部件和第二网状部件覆盖所述框架中的各自的第一开口和第二开口,所述第一开口邻近所述第二开口。
条目25.如条目22-24中任一项所述的植入物,其中所述第二网状部件邻近所述第一网状部件布置。
条目26.如条目22-25中任一项所述的植入物,其中所述第二网状部件的边缘邻接所述第一网状部件的边缘。
条目27.如条目22-26中任一项所述的植入物,其还包括沿着所述近侧区耦接至所述框架的第三网状部件。
条目28.如条目27所述的植入物,其中所述第三网状部件邻近所述第一网状部件布置。
条目29.如条目27-28中任一项所述的植入物,其中所述第三网状部件包含与所述第一孔隙度不同的第三孔隙度。
条目30.如条目27-29中任一项所述的植入物,其中所述第二网状部件包含第二孔隙度,并且所述第三网状部件包含与所述第二孔隙度不同的第三孔隙度。
条目31.如条目30所述的植入物,其中所述第一孔隙度不同于所述第二孔隙度和所述第三孔隙度。
条目32.如条目21-31中任一项所述的植入物,其中所述网状部件围绕基本上全部所述框架。
条目33.如条目21-32中任一项所述的植入物,其中所述网状部件沿着所述框架的内部设置。
条目34.如条目21-33中任一项所述的植入物,其中所述网状部件沿着所述框架的外部设置。
条目35.如条目21-34中任一项所述的植入物,其中所述网状部件在多个耦接点处固定耦接至所述框架。
条目36.如条目21-35中任一项所述的植入物,其中所述框架和所述网状部件焊接在一起。
条目37.如条目21-36中任一项所述的植入物,其中所述多根第一长丝和第二长丝交错编织以形成单层。
条目38.如条目21-37中任一项所述的植入物,其中所述植入物包含球状形状。
条目39.如条目38所述的植入物,其中所述植入物包含球形形状。
条目40.如条目38-39中任一项所述的植入物,其中所述植入物包括圆化的第一部分和大致圆柱形的第二部分。
条目41.一种操作植入物组件的方法,所述方法包括:使用系带将端部管状编织物封闭成大致闭合的构型,所述管状编织物包括相交以界定开口的长丝,所述长丝和所述开口共同界定框架孔隙度;在将所述端部保持为大致闭合的同时,将型材插入开口端以围绕所述型材布置所述编织物;基于所述型材设定装置框架形状以提供植入物;将网状部件耦接到所述植入物上,所述网状部件包括共同界定允许血流流经的第一孔隙度的长丝和开口,所述第一孔隙度小于所述框架孔隙度,用于限制进入所述植入物的血流。
条目42.如条目41所述的方法,其中所述耦接包括将所述网状部件层合到所述管状编织物上。
条目43.如条目41-42中任一项所述的方法,其中所述耦接包括将所述网状部件焊接至所述管状编织物。
条目44.如条目41-43中任一项所述的方法,其中所述网状部件包括第一网状部件,并且所述耦接包括将第二网状部件耦接至邻近所述第一网状部件的所述植入物。
条目45.如条目44所述的方法,其中所述耦接包括将第三网状部件耦接至所述植入物。
条目46.如条目41-45中任一项所述的方法,其中所述耦接包括沿着所述植入物的外部布置所述网状部件。
条目47.如条目41-46中任一项所述的方法,其中所述封闭包括使用所述系带使管状编织物的中间区段塌缩成大致闭合的构型并且将所述管状编织物的第一管状区段内翻到所述系带上方的所述中间区段处以在所述编织物中产生双层,使得所述编织物具有管状构型,所述管状构型具有在所述中间区段处的封闭端和与所述中间区段相对的开口端。
条目48.如条目41-47中任一项所述的方法,其还包括从所述编织物移除所述系带。
条目49.如条目47所述的方法,其中所述移除所述系带包括在热定形期间烧掉所述系带。
条目50.如条目41-49中任一项所述的方法,其还包括从所述编织物移除所述型材。
如条目41-50中任一项所述的方法,其中所述移除包括完整地移除所述型材。
条目52.一种植入物,其具有前述条目中任一项所述的特征中的任一种。
条目53.一种制造前述条目中任一项所述的植入物或组件的方法。
应当理解的是,以上一般性描述和以下详细描述均为示例性的和阐释性的,且旨在提供对本主题技术的进一步阐释。
附图说明
包括在内以提供对本主题技术的进一步理解且并入本说明中并构成本说明书的一部分的附图示出了本公开的多个方面,这些附图连同描述起到阐释本主题技术的原理的作用。
图1为根据一些实施方案的具有框架和网状部件的可植入装置的一个实施方案的示意图。
图2为根据一些实施方案的可植入装置的示意图,其中网状部件包括具有不同孔隙度的多个单独的网状部件。
图3为根据一些实施方案的另一可植入装置的示意图,其中网状部件包括沿着整个框架延伸并且具有不同孔隙度的一对网状部件。
图4和图5示出根据一些实施方案的可植入装置的示意图,所述可植入装置具有耦接至其框架的一个或多个网状部件条带。
图6和图7示出根据一些实施方案的呈组装前状态的可植入装置,其中所述可植入装置包括不同的网状部件和/或不同孔隙度的网状部件。
图8A-8D示出根据一些实施方案的使用管状编织物材料形成可植入装置的方法中的示意性步骤。
图9和图10示出根据一些实施方案的布置在沿着血管定位的动脉瘤内的可植入装置的示意图。
详述
在以下详细描述中,阐述了许多具体细节,以提供对本主题技术的充分理解。应当理解,本主题技术可以在没有这些具体细节中的一些的情况下实践。在其它情况下,熟知的结构和技术未被详细示出,以免使本主题技术变模糊。
现参照图1,示出可植入装置100,其包括框架102和网状部件104。网状部件104耦接至构成框架102的长丝106。例如,框架102可由多根编织长丝106形成,编织长丝106彼此相交以沿着框架102的外部提供多个开口108。可例如通过图8A-8D中公开的制造方法使用缝合线、接头或标记带116使长丝106在端部处耦接在一起。框架102可由少至六(6)根的长丝形成以实现可易于压缩的框架同时提供支架,网状部件104耦接至所述支架。开口108可被定义为由长丝106限定的框架102的外表面中的空隙。相似地,网状部件104可由彼此相交以提供多个开口的多根编织长丝形成。用于框架102和/或网状部件104的材料可包括任何已知的生物相容性或可生物降解的材料,包括不锈钢、镍钛诺、钴铬或乳酸-羟基乙酸共聚物(PLGA)。
如图1所示,网状部件104可耦接至框架102以便在框架102的整个一个或多个开口108上延伸。这样做时,网状部件104可在一根或多根长丝106上方延伸或与其重叠。根据一些实施方案,网状部件104可耦接至与网状部件104重叠的每根长丝106。然而,网状部件104还可耦接至长丝106与被网状部件104重叠的仅一部分,并且在一些情况下,耦接至长丝中的至少一根(但非每根)。
图1中示出的网状部件104在框架的整个开口上延伸并且耦接至形成网状部件在上方延伸的开口的外边界的长丝。这些边界(如图1中的元件120所示)表示网状部件104和框架102之间的附接点。如上所述,网状部件104可耦接至框架102的与网状部件104重叠的长丝中的每一根。然而,根据一些实施方案,框架102可耦接至框架102的与网状部件104重叠的长丝中的仅数根。
仍参照图1,框架102可界定远侧区130和近侧区132。远侧区130和近侧区132可为装置100的相对区。在一些实施方案中,网状部件104可沿着远侧区130和近侧区132中的一者或两者延伸。远侧区130和近侧区132(大致如图1中所示)可占装置100的总体表面积的小部分或大部分。在一些实施方案中,远侧区130和近侧区132可不仅基于装置的区的位置进行区分,而且还可基于装置的物理形态(例如形状、框架性质、长丝构型或其他此类方式)进行区分。
可通过医疗装置制造中熟知的多种机械、化学和热法使网状部件104耦接至可植入装置100。根据选择用于植入物制造的材料,可对网状部件104进行点焊、部分熔融或加热,或使用粘合剂或胶水进行耦接。或者,可通过编织、穿丝或以其他方式使网状部件104与框架102的一根或多根长丝106互连来将网状部件104耦接至框架102。在一些实施方案中,网状部件104和长丝106之间的耦接可需要或利用另外的部件或材料。此类实施方案可例如利用缝合线或系带来将网状部件104耦接至长丝106。
在一些实施方案中,可通过施加压力和/或热、粘合剂或其他粘结方法(例如上文所述的那些)来将网状部件104层合至框架102。另外,在一些实施方案中,可实现多个网状层与至少一个框架层的层合。如本文中所讨论,可将各种涂料和其他材料施加至可植入装置100的结构,其还可起到维持网状部件104和框架102之间的接合的作用。
在一些实施方案中,希望对一根或多根长丝106和/或网状部件104的至少一部分进行预处理以增强耦接过程。例如,可对一根或多根长丝106(或框架102的至少一部分)和/或网状部件104的至少一部分进行预处理以修改诸如表面粗糙度等结构特性和/或向其添加涂层。表面粗糙度可通过如下方式来增加:在编织到框架102的结构中之前或在编织到网状部件104的结构中之前,使长丝和/或网状部件的一部分通过颗粒或化学浴或以其他方式物理接触长丝和/或网状部件,例如以单独线材的形式。另外,可在尝试耦接框架102和网状部件104之前涂覆一根或多根长丝106(或框架102的至少一部分)和/或网状部件104的至少一部分,例如以单独线材的形式。例如,可在尝试耦接框架102和网状部件104之前向长丝和/或网状部件的一部分涂覆氨基甲酸乙酯。因此,如果长丝或网状部件中的一者或两者具有涂层,则可在耦接过程中施加热以引起涂层(例如氨基甲酸乙酯)熔融并且将框架102和网状部件104耦接在一起。
在各实施方案中,在通过具有变化孔距(pitch)的单个网状部件或通过耦接至框架102的若干个网状部件104的组合时,可植入装置100的孔隙度可逐渐变化。当沿着至少近侧区132耦接至框架102时(如图1中所示),可植入装置100的孔隙度从远侧区132到近侧区132变化。因此,由于可植入装置100的沿着远侧区130的孔隙度大于沿着近侧区132的孔隙度,进入可植入装置100的血流可沿着近侧区132比沿着远侧区130更受限制。使用此独特的构型,临床医生可将可植入装置100布置在脉管系统内,例如将近侧区132布置在动脉瘤的颈部,以显著减小进入弱化结构的血流并促进所产生的动脉瘤内皮化。
另外,可植入装置可包括两个以上的区,例如三个、四个、五个或多个地区,例如如图2和图5中所示。装置的区也可基于网状部件的存在而开始或结束。因此,如果存在一个或多个网状部件和支撑件,则可植入装置的区可开始,从而产生装置的不同区。因此,具有单片网状部件的装置可具有远侧区和近侧区,所述远侧区被定义为网状部件沿其延伸的框架区,所述近侧区被定义为框架的剩余表面区域。
如本文所用,所述术语“孔隙度”可指可植入装置的表面孔隙度。表面孔隙度可被定义为空的空间(即,网状部件和/或框架中的开口的表面积)与装置的给定区的总表面积的比率。为了计算可植入装置沿着由网状部件所覆盖的框架的特定区的孔隙度,开口的表面积可如以下方式求得:首先测定特定区中的长丝(考虑到特定区中的所有长丝)的总表面积,然后基于框架的长丝的尺寸(宽度或直径和长度)和/或网状部件的长丝的尺寸(宽度或直径和长度)来计算总长丝面积的形貌或2-D表示。然后可从给定区的总表面积中减去框架和/或网状部件的总表面积以便提供给定区的开口的所得表面积。
在计算装置的给定区或区段的孔隙度时,本领域的技术人员可使用给定装置的图像来引导或促进开口表面积与总表面积比率的计算。此类计算可依赖于关于可植入装置中所使用的框架和/或网状部件中纤维或长丝的尺寸和/或量的信息。
图1-2示出在一些实施方案中,可提供可植入装置,其中网状部件包括多个面板,所述多个面板在整个框架上部分或完全延伸和/或提供不同的孔隙度以便创建可植入装置,其在沿着可植入装置的一个或多个位置处具有特定的孔隙度特性。
例如,如中所示图1,可植入装置100的网状部件104耦接至装置100的框架。在这样的实施方案中,网状部件可界定单一或大致恒定的孔隙度。
如图1中所示,根据一些实施方案,框架102(以及本文所公开的框架中的任一种)可被配置成使得远侧区160和近侧区162各自表示“编织球”的“端部”,框架102的长丝106在所述端部处会聚,从而与框架102的中央区164相比创建相对较低的孔隙度。因此,网状部件104至近侧区162的施加或耦接可导致远侧区162具有比近侧区160低得多的孔隙度。然而,当与装置100的远侧区162的端部168处的孔隙度相比时,近侧区162的孔隙度可沿着远侧区162与中央区164的边界从相对较高的孔隙度进行变化。装置沿着远侧区162的孔隙度的变化(即使网状部件104可界定基本上恒定的孔隙度)可归因于长丝106在接近植入物100的远侧区162的端部168时的会聚。
鉴于由管状编织材料形成的框架的潜在可变孔隙度结构,其中编织物的相对端部塌缩,从而导致编织物的长丝朝向彼此会聚并且创建孔隙度降低的区,如上文关于“编织球”所讨论,一些实施方案可被配置成使得一个或多个网状部件耦接至框架并且界定可变孔隙度,所述可变孔隙度在汇总或与框架的下面或上面区段的孔隙度组合时界定沿着一个或多个区段或可植入装置的基本上全部的表面区域基本上恒定的孔隙度。因此,一些实施方案可提供可植入装置,其具有编织材料,所述编织材料的可变孔隙度被具有可变孔隙度的网状部件抵消,使得框架和网状部件在区段中的任何给定位置或沿着可植入部件表面的任何位置处的复合孔隙度界定基本上恒定的孔隙度。
图2示出可植入装置200的一个实施方案,其中多个网状部件或面板202,204,206已耦接至装置200的框架210。框架210可由编织材料形成,使得框架210的长丝212在框架210的相对端部或极点处会聚,如上文关于图1所讨论。可例如通过图8A-8D中公开的制造方法利用缝合线、接头或标记带216使长丝212在端部处耦接在一起。图2示出的实施方案示出其中装置200具有可变孔隙度分布的实例。图2示出耦接至框架210的三个不同的孔隙度面板202,204,206。尽管已以梯度方式示出从中央区至近侧区降低的孔隙度,技术人员将会理解可预想变化孔隙度面板的任何组合和数量以实现整个可植入装置200的所需孔隙度。
例如,图2示出多个网状部件可相对于彼此以毗连或邻接关系耦接至框架210。因此,给定的网状部件220可邻接两个不同的网状部件222,224。例如,网状部件220可耦接至充当开口边界的长丝226,228,各自的网状部件220,222,224在所述开口边界上延伸。另外,不同的网状部件不仅可沿着框架的区段或区邻近彼此布置,而且总体上如图2中所示,网状部件220,222,224各自可具有不同的孔隙度。
图3示出另一可植入装置250,其包括第一网状部件252、第二网状部件254和与第一网状部件252和第二网状部件254耦接的框架256。第一网状部件252和第二网状部件254可共同地在框架的大致球形几何形状的整个表面区域上延伸。
如图3中所示,两个或更多个网状部件252,254可用于确立装置250在装置250的特定位置处的给定孔隙度特性。用于此类实施方案中的网状部件可沿着其至少一部分具有基本上恒定的孔隙度和/或具有可变孔隙度,如本文中所讨论。
一个或多个网状部件可沿着框架的外侧面(outer aspect)或表面耦接至框架以使得网状部件表示耦接至框架的最外层,或沿着框架的内侧面(inner aspect)或内部耦接至框架以使得框架将网状部件大致包封在框架的内部空间内或主要沿着框架的面向内部的表面耦接至网状部件。
图1-3总体上示出网状部件可被配置成覆盖框架开口的基本上全部,使得网状部件在给定开口的整个总表面区域上延伸。现参照图4和图5,提供可植入装置的另外的实施方案。在一些实施方案中,网状部件在框架的整个开口上延伸,使得网状部件覆盖开口总表面积的约30%至约70%。因此,网状部件可耦接至框架,而不会用框架的相应长丝来具体界定网状部件的边界。因此,网状部件可(如上文示出的实施方案所示)仍然耦接至框架的一根或多根长丝,但沿着网状部件的周边或边缘与框架的互连与上文讨论的实施方案相比可能较少。然而,可实现网状部件和长丝之间的足够耦接以便允许此类实施方案有效地实现一体化或复合单元。另外,为了进一步确保框架和网状部件之间的连通度,就其他实施方案而言,网状部件可设置在框架长丝的内侧面或表面内并且耦接至所述内侧面或表面。
具体参照图4,可植入装置300可包括耦接至框架304的网状部件302(例如,网状部件条带)。网状部件302可包括相对于框架304的长丝306大致横向延伸的边缘308。可例如通过图8A-8D中公开的方法利用缝合线、接头或标记带316使长丝306在端部处耦接在一起。网状部件302或条带可具有基本上恒定的孔隙度或可包含可变孔隙度。网状部件302可沿着网状部件302重叠与长丝306重叠的区域耦接至长丝306。然而,网状部件302的周边或边缘308的少于大部分(例如,少于50%、少于20%或少于10%)可直接耦接至长丝306(此类布置方式可与图1-3中示出的一般布置方式形成对比)。
图5示出另一可植入装置350,其中装置350包括耦接至框架356的第一网状部件352和第二网状部件354(例如,网状部件的条带)。第一网状部件352和第二网状部件354可各自与装置350的长丝重叠,并且可在框架356上彼此间隔开或邻接彼此布置。第一网状部件352和第二网状部件354可包含不同的孔隙度、基本上恒定的孔隙度或可变的孔隙度。
第一网状部件352和第二网状部件354可沿着框架356邻近彼此延伸。然而,可提供一些实施方案,其中不同的网状部件沿着框架在框架的不同位置延伸。另外,图5示出一个实施方案,其展示了网状部件360,362的周边或边缘可以类似于图4中描述的方式(为简明起见,所述讨论不再重复)横贯框架356的开口。
根据一些实施方案,提供用于形成具有一个或多个本文所公开的特征的装置的方法。框架和网状部件可在框架成形为球状部件(例如球形部件)之前或之后彼此耦接。例如,图6和图7示出可植入装置的中间构型,其中装置由编织管状或激光切割材料形成。例如,在图6中,管状部件400可用作装置的框架,并且一个或多个网状部件402可以与图1-3中所示类似方式耦接至管状部件400。另外,图7示出另一管状部件410,网状条带412以与关于图4和图5中所示类似的方式耦接至管状部件410。
根据一些实施方案,当框架包含编织材料时(即,当使用管状编织物形成框架时),一些实施方案所提供的一个优点包括能够使用多种编织物和/或线材构型中的任一种。例如,管状编织物可用少至4根、5根或6根线材形成。一些实施方案的一个显著优点是带少量编织物网的极小框架。一些实施方案的另一个优点是与采用36根、72根、144根或更多根线材的其他装置相比,在装置前移期间可能的显著减小的轮廓。此类减小的轮廓允许一些实施方案通过尺寸小得多的导管,例如6Fr、5Fr或4Fr递送。可通过对编织管端部处的线材端部的数量进行计数来确定线材的数量。在具有较少数量线材(例如,12根或更少的线材)的一些实施方案中,框架的主要功能是提供结构和膨胀特性。因此,在此类实施方案中,网状部件可主要提供可植入装置所需的孔隙度分布。
在本文所公开的任一实施方案中,网状部件可任选地包括聚合物覆盖物、层或涂层,所述聚合物覆盖物、层或涂层在框架呈圆化或球状构型(如图1-5中所示)之后施加至框架,或在框架组装之前施加至管状构件,如关于图6-8D所讨论和示出。例如,在框架预先形成后(当仍呈管状形式时),可对聚合物覆盖物进行激光加工以在聚合物覆盖物中产生孔洞图案。孔洞图案可在聚合物覆盖物中提供基本上恒定的或可变的孔隙度。聚合物覆盖物可包含多种聚合物中的任一种,包括但不限于ePTFE、聚氨酯、氨基甲酸乙酯、硅酮和/或本领域中已知的其他材料。另外,在一些实施方案中,装置可包括网状部件和涂层,例如药物洗脱涂层。
根据一些实施方案,制造可植入装置的方法可如图8A-8D中所示执行。在形成合适的管状部件430(包括基础框架、网或编织物图案432和网状部件434)后,将管状部件430布置在线材440上方(即,将线材440插入管状构件430的内腔中)。然后,如图8A中所示,可使用缝合线442封闭管状构件可或将其向下拴系到线材构件440上,从而将管状构件430的中间区段446朝向线材440拉伸。
然后,在图8B中,可将型材450插入管状构件430的腔内并且可将管状构件的一个端部外翻到中间区段446上方,直至管状构件的外翻区段在管状构件430的其他区段上形成外层。因此,管状构件可从而形成内层452和外层454。根据一些实施方案,网状部件434可插置在内层452和外层454之间。
可使用用于布置管状构件430的其他压缩形式和方法,例如2011年3月15日提交的美国专利申请No.13/048,648中描述的那些,所述美国专利申请的全文以引用方式并入本文。
图8C示出了内层454和外层452,454可围绕型材450伸展和拉伸并且可使用缝合线、接头或标记带460或合适的压型设备进行紧固,如上述专利申请中所讨论。然后,可对装置进行热定型(例如,可在550℃下持续五分钟来对镍钛诺编织物进行热定型)。在热定型过程中,可烧掉缝合线材料,从而移除在中央区446的折叠部处实现零或接近零的半径弯曲的任何障碍。然后,将对装置形状进行热定型后所保留的额外材料462进行修剪,如图8D中所示,从而留下完整的植入物形状470。在此类制造方法中,完成的植入物470可从而用框架部件的一个或多个层包封一个或多个网状部件或层。例如,在开始组装装置之前,网状部件可耦接至管状部件的内表面或侧面。在用此管状部件组装装置期间,管状部件可外翻到管状部件的被网状部件耦接的部分上方,从而将网状部件包封在成框部件或长丝的双层之间。
在根据本文所公开的一些实施方案实施用于制造可植入装置的方法时,可对构型、尺寸、孔隙度分布和网状部件的数量进行改变或修改以便实现具有所需孔隙度特性的最终可植入装置。一些孔隙度特性已在上文中关于图1-5示出,并且可如本文所讨论进行修改。
递送方法
此外,可实现用于递送包括一个或多个可植入装置的可植入装置的递送系统和程序,如本文中所讨论。另外,提供用于将可植入装置递送至动脉瘤和/或重获装置以便移除或重新布置的系统和方法。
根据一些实施方案,可植入装置中的一个或多个可释放到目标动脉瘤中,并且在一些实施方案中,相对于动脉瘤开口或颈部和/或邻近动脉瘤的一个或多个穿支血管(例如,穿支动脉或小动脉)进行特定取向。
在一些实施方案中,可植入装置可释放到目标脉管系统中,并且使用球囊或其他装置进行机械膨胀。例如,可植入装置可进行球囊膨胀以促进装置的框架的膨胀。此膨胀力可确保被涂覆或复合材料装置能够按照需要进行充分膨胀。因此,在一些实施方案中,
在使用时,进入导管在神经血管中行进,如本领域中所常见的。适用于通过弯曲神经血管的空间进入治疗部位的导航的合适的微导管在共同转让的美国专利No.7,507,229中公开,所述美国专利的全部内容据此并入本文。
在一些实施方案中,可植入装置随着装置膨胀可重新布置在动脉瘤内。装置的重新布置可允许临床医生定位装置的邻近或远离动脉瘤颈部的较低孔隙度区段。装置的重新布置可允许临床医生定位装置的邻近与动脉瘤相邻的一个或多个穿支血管(例如,穿支动脉或小动脉)的较高平均孔隙度区段。装置的重新布置还可允许临床医生定位装置的邻近分叉的较低孔隙度部分。装置的重新布置还可允许临床医生定位装置的朝向或位于动脉瘤基底中的较高平均孔隙度部分。
例如,现参照图9和图10,还可根据本文所公开的一些实施方案执行植入医疗装置的方法。图9和图10均示出位于载瘤血管502上的动脉瘤500。图9示出了可使用递送装置518将可植入装置510的网状部件512布置在动脉瘤500内,使得网状部件512在动脉瘤500的整个开口520上延伸。网状部件的存在以及降低的孔隙度和从而提供的增加的表面积可有利地减少流入或流出动脉瘤500的血流并且促进开口520处的内皮化。
相似地,图10示出可植入装置540,其中装置的网状部件542布置在动脉瘤500内,并且更具体地,紧靠动脉瘤500的圆顶部548或与开口520相对或远离开口520而间隔。另外,装置的相对区,例如区550,可被配置成界定与装置沿着网状部件542所占据的区的孔隙度相比相对较小的孔隙度,区550可使用递送装置558沿着开口520布置。在这样的实施方案中,以此方式放置可植入装置540可允许可植入装置540沿着动脉瘤的圆顶部548之间的内皮化并且允许一些血流进或流出动脉瘤。
另外,根据一些实施方案,可植入装置或可植入装置的一部分可与其他治疗模式结合使用。例如,可植入装置可被递送并且随后被液体栓塞所填塞。液体栓塞的注入可增加可植入装置内的整体填塞密度。另外,线圈可通过可植入装置的开口端或孔引入。
在实施用于将可植入装置置于动脉瘤内并将线圈、可膨胀部件或其他材料注入可植入装置中的方法时,可植入装置的开口端或最宽空隙可布置在动脉瘤的颈部,以便有利于导管的远侧端部插入开口端或可植入装置的长丝之间(即插入空隙中)。在具有用于可植入装置的编织材料的实施方案中,编织物图案可适当对准以有利于材料进入可植入装置中。如本文所公开的其他实施方案中,可植入装置可包含射线不可透材料或有利于可视化并且能够使临床医生将可植入装置按照需要在动脉瘤内对准的组分。
插入可植入装置中的线圈、可膨胀部件和/或其他材料的复合效应可提供上文讨论的相对于其他可植入装置的优点和有益效果。因此,所述临床医生可确定和控制各种囊内植入物特性,包括孔隙度、组成、材料、形状、尺寸、连通度、相互接合性、涂层等。
根据一些实施方案,可提供具有可植入装置和至少一个线圈、可膨胀部件和/或其他材料的系统或套件。
复合孔隙度
在一些实施方案中,可植入装置的复合结构可包含两种或三种具有不同孔隙度的材料。另外,可植入装置的复合结构可包含五种、六种或更多种具有不同孔隙度的材料。可植入装置的一些实施方案可被配置成提供特定的孔隙度分布。孔隙度分布可包括整个可植入装置的整个表面上的单一、一致的平均孔隙度,或具有不同平均孔隙度的多个平均孔隙度区、部分或区,其共同形成复合材料可植入装置。
例如,一些实施方案可被配置成具有低平均表面孔隙度。出于说明的目的,与用于示出中等孔隙度和低孔隙度结构的具有较小尺寸六边形的六边形图案相比,图中使用具有较大尺寸六边形的六边形图案示出高表面孔隙度。低表面孔隙度可对流经的血流提供较高的阻力,这有利于血栓形成。当此类低孔隙度可植入装置植入动脉瘤中时,此类装置可趋于将动脉瘤与载瘤血管分离并且使动脉瘤内的血流速度最小化,同时支撑动脉瘤壁。
反之,随着表面孔隙度增加,通过可植入装置的血流可增加,从而由于对流经血流的较低阻力而趋于提供对血栓形成的较低支撑。然而,本文所公开的一些实施方案的实现在于高孔隙度结构还可支撑动脉瘤壁;有利地帮助选定动脉瘤形态的愈合和血栓形成;允许流至其他血管(例如,支血管、穿动脉或小动脉);和/或允许引入其他材料,例如液体栓塞等。
可植入装置的孔隙度可沿着其任何部分变化,包括1微米或更大的孔尺寸的任何组合。另外,框架和网状部件的孔或开口的范围可为1μm至约400μm、约5μm至约300μm、约8μm至约200μm、约10μm至约150μm、约15μm至约80μm,或在一些实施方案中,为约20μm至约50μm。另外,装置的至少一部分或区段可包含介于约1μm和约150μm之间的平均孔隙度。另外,至少一部分或区段可包含介于约100μm和约200μm之间的平均孔尺寸。此外,至少一部分或区段可包含介于约200μm和约300μm之间的平均孔尺寸。当使用多个区段或部分形成可植入装置时,每个区段或部分可具有在上述任意范围内的平均孔隙度。此外,孔尺寸可使用“内切圆”计算,其中给定孔的尺寸由适合给定孔的最大圆的直径表示。
另外的实施方案
根据一些实施方案,可植入装置的至少一部分可包含用于增强至少一种或每种可植入装置的治疗、膨胀或成像性质或特性的涂层或材料。
在一些实施方案中,可植入装置可涂覆有生物相容性材料以促进内皮化或提供治疗效果。
涂层可包括血栓形成涂层例如纤维蛋白、纤维蛋白原等;抗血栓形成涂层例如肝素(及其衍生物)、urukinase或t-PA;以及内皮化促进涂层或协助转运蛋白例如VEGF和RGD肽;和/或它们的组合。还预想了药物洗脱涂层和药物洗脱泡沫复合材料例如抗炎或抗菌涂层。这些药物洗脱组分可包括营养素、抗生素、抗炎剂、抗血小板剂、麻醉剂例如利多卡因,和抗增殖剂例如紫杉酚衍生物例如紫杉醇。还预想了亲水性、吸湿性和疏水性材料/剂。
任选地,可植入装置还可包含膨胀限制涂层,其将装置从其自然膨胀速率减慢至较慢膨胀速率的膨胀,使得在膨胀过程中,装置的位置可在动脉瘤内进行调整或装置可从动脉瘤移除(如果需要)。可用作膨胀限制涂层的聚合物的例子可包括疏水性聚合物、有机物非极性聚合物、PTFE、聚乙烯、聚苯硫醚、油类以及其他类似的材料。
在实施方案中,可植入装置的仅特定片段可嵌有或涂覆有试剂以向可植入装置提供所需特性。例如,可植入装置可包含非血栓形成涂层,其可施加于可植入装置的下半部以最小化此位置处的凝血。此类涂层在位于分叉处的动脉瘤中是有利的,使得允许流向支动脉的血流通过具有非血栓形成涂层的泡沫结构片段。被涂覆区域可与可植入装置的其余部分具有不同的颜色以辅助外科医生识别此区域。
任选地,被涂覆区域还可包含射线不可透材料以辅助外科医生目视观察可植入装置并将其相对于动脉瘤放置在期望的取向上。通过向材料中添加射线不可透填料(其在一些实施方案中包含泡沫材料)例如铋或附着射线不可透标记物来使可植入装置可具有射线不可透特性。或者,射线不可透材料可耦接至可植入装置,例如通过浸涂、喷涂或以其他方式进行机械、化学或热耦接、注入或掺入可植入装置中。
一些实施方案的另外的方面
本文所讨论的设备和方法不限于在血管系统内部署和使用医疗装置或支架,而是可包括许多另外的治疗应用。其他治疗部位可包括身体中包括任何中空解剖结构的区域或区。
提供前面的描述使本领域的技术人员能够实施本文描述的各种构造。虽然本主题技术已特别地参照各种附图和构型进行了描述,但应当理解,这些仅用于例示目的,而不应视为限制本主题技术的范围。
可以有许多其他方式来实现本主题技术。在不脱离本主题技术的范围的情况下,本文所述各种功能和元件可以与所示的那些不同地划分。对这些构型的各种修改对于本领域的技术人员将显而易见,并且本文限定的一般原理可以适用于其他构型。因此,在不脱离本主题技术的范围的情况下,可以由本领域的普通技术人员对本主题技术做出许多改变和修改。
应当理解,所公开的过程中的步骤的具体顺序或者层次是示例性方法的说明。基于设计偏好,应当理解在过程中的步骤的具体顺序或层次可以重新安排。步骤中的一些可以同时执行。所附方法权利要求以示例顺序提供了各种步骤的要素,而并不意图局限于所提供的具体顺序或层次。
此外,就在说明书或权利要求书中使用术语“包括”、“具有”等来说,这种术语旨在以与术语“包含”类似的方式为包含性的,如“包含”在权利要求中用作过渡词时所解释的。
词语“示例性的”在本文中用来表示“充当示例、实例或例示”。本文描述为“示例性的”任何实施方案不一定被理解为相比其他实施方案优选的或有利的。
除非具体阐明,对单数元件的引用并非意图表示“一个且仅一个”,而是表示“一个或多个”。阳性的代词(例如,他的)包括阴性和中性(例如,她的和它的),反之亦然。术语“一些”是指一个或多个。带下划线的和/或斜体的标题和子标题仅仅为了方便而使用,而不限制本主题技术,并且不结合本主题技术的描述的解释来指代。本领域的普通技术人员已知或以后会知道的贯穿本公开所描述的各种构型的元件的所有结构和功能等同物明确地以引用方式并入本文中,并且旨在由本主题技术涵盖。此外,本文所公开的任何内容都并非旨在专用于公众,不论这样的公开是否在上述描述中被明确地叙述。
尽管详细描述包含许多具体细节,但这些细节不应理解为限制本主题技术的范围,而是仅仅说明本主题技术的不同示例和方面。应当理解,本主题技术的范围包括上文未详细讨论的其他实施方案。在不脱离本公开的范围的情况下,可以对本文所公开的主题技术的方法和设备的布置、操作和细节做出各种其他修改、改动和变型。除非另有说明,以单数引用的元件并非意图表示“一个和仅一个”,除非明确地表述,而是表示“一个或多个”。此外,一种装置或方法没必要为了包涵在本公开的范围内而解决可由本公开的不同实施方案解决的每个问题(或具有可由本公开的不同实施方案实现的每个优点)。本文使用“可”及其派生词应按与肯定能力相对的“可能地”或“任选地”的含义理解。
Claims (20)
1.一种用于闭塞患者的脉管系统的目标区域的植入物,所述植入物包括:
框架,其包括界定多个开口的多根编织长丝,所述多根长丝和所述多个开口共同界定框架孔隙度,所述框架包括远侧区和近侧区,所述框架能够从压缩构型膨胀至膨胀构型;和
网状部件,其沿着所述框架的至少近侧区耦接至所述框架,所述网状部件包括多根长丝和多个开口,所述多根长丝和所述多个开口共同界定允许血流流经的第一孔隙度,所述第一孔隙度小于所述框架孔隙度,使得进入所述植入物的血流沿着所述框架的所述近侧区比沿着所述框架的所述远侧区更受限制。
2.如权利要求1所述的植入物,其中所述网状部件为第一网状部件,并且所述植入物还包括沿着所述近侧区耦接至所述框架的第二网状部件。
3.如权利要求2所述的植入物,其中所述第二网状部件包含与所述第一孔隙度不同的第二孔隙度。
4.如权利要求2所述的植入物,其中第一网状部件和第二网状部件覆盖所述框架中的各自的第一开口和第二开口,所述第一开口邻近所述第二开口。
5.如权利要求2所述的植入物,其还包括沿着所述近侧区耦接至所述框架的第三网状部件。
6.如权利要求5所述的植入物,其中所述第三网状部件包含与所述第一孔隙度不同的第三孔隙度。
7.如权利要求5所述的植入物,其中所述第二网状部件包含第二孔隙度,并且所述第三网状部件包含与所述第二孔隙度不同的第三孔隙度。
8.如权利要求1所述的植入物,其中所述网状部件在多个耦接点处固定耦接至所述框架。
9.如权利要求8所述的植入物,其中所述网状部件在所述多个耦接点处焊接至所述框架。
10.一种用于闭塞患者的脉管系统的目标区域的植入物,所述植入物包括:编织框架,其包括彼此相交以界定开口的长丝,所述长丝和所述开口共同界定框架孔隙度,所述框架能够从压缩构型膨胀至膨胀构型;和网状部件,其耦接至所述框架,所述网状部件包括共同界定允许血流流经的第一孔隙度的长丝和开口,所述第一孔隙度小于所述框架孔隙度,用于限制进入所述植入物的血流。
11.如权利要求10所述的植入物,其中所述网状部件为第一网状部件,并且所述植入物还包括耦接至所述框架的第二网状部件。
12.如权利要求11所述的植入物,其中所述第二网状部件包含与所述第一孔隙度不同的第二孔隙度。
13.如权利要求11所述的植入物,其中所述第二网状部件邻近所述第一网状部件布置。
14.如权利要求11所述的植入物,其还包括沿着所述近侧区耦接至所述框架的第三网状部件。
15.如权利要求10所述的植入物,其中所述网状部件围绕基本上全部所述框架。
16.如权利要求10所述的植入物,其中所述多根第一长丝和第二长丝交错编织以形成单层。
17.一种操作植入物组件的方法,所述方法包括:
使用系带将端部管状编织物封闭成大致闭合的构型,所述管状编织物包括相交以界定开口的长丝,所述长丝和所述开口共同界定框架孔隙度;
在将所述端部保持为大致闭合的同时,将型材插入开口端以围绕所述型材布置所述编织物;
基于所述型材设定装置框架形状以提供植入物;以及
将网状部件耦接到所述植入物上,所述网状部件包括共同界定允许血流流经的第一孔隙度的长丝和开口,所述第一孔隙度小于所述框架孔隙度,用于限制进入所述植入物的血流。
18.如权利要求17所述的方法,其中所述网状部件包括第一网状部件,并且所述耦接包括将第二网状部件耦接至邻近所述第一网状部件的所述植入物。
19.如权利要求18所述的方法,其中所述耦接包括将第三网状部件耦接至所述植入物。
20.如权利要求17所述的方法,其中所述耦接包括沿着所述植入物的外部布置所述网状部件。
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JP2017060751A (ja) | 2017-03-30 |
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