CN106999286A - 可经皮植入的髓核假体 - Google Patents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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Abstract
一种用于髓核植入体的多腔室球囊具有限定与阀体成一体的内腔室和外腔室的弹性膜。该阀体包括核部分和用于密封内腔室和外腔室的密封膜。一种用于制造多腔室球囊的组件包括球囊心轴,该球囊心轴可以在硅树脂分散液中浸涂以制造用于与阀体成一体的内腔室和外腔室的弹性膜。形成在心轴上的弹性膜部分地反转以形成同轴弹性体结构,其中较小的内腔室设置在较大的外腔室内。阀被合并到内腔室和外腔室以形成一体的结构。
Description
相关申请的交叉引用
本申请要求2014年11月4日提交的、申请号为62/074,925的美国临时专利申请的优先权,其全部内容通过引用并入本文。
背景
1.技术领域
概括而言,本申请涉及用于修复椎间盘的方法和装置。更具体地,本申请涉及经皮置入的可植入椎间盘替代物和用于制造这种椎间盘替代物/假体的方法。
2.背景技术
常见的医学问题是归因于由创伤、老化过程或其他疾病引起的椎间盘损伤的背痛。已经提出的一种治疗方法是移除现存的髓核并且使用开腹手术或微创外科技术利用在原位形成的髓核假体置换所述髓核。一种所提出的方法包括以下步骤:(i)提供诸如球囊之类的模具以包含能够在椎间隙内原位固化的可流动固化材料,(ii)提供导管以将模具腔连接到可流动固化材料的源,(iii)将可流动固化材料输送到模具中以填充腔,和(iv)允许可固化材料固化。
用于在原位形成髓核假体的现有技术没有取得令人信服的临床接受度或商业成功。本申请发明人确定的一个问题是包括椎骨端板的脊椎骨元件之间的弹性模量的实质差异,一方面是纤维环之间的差异,另一方面是植入元件之间的差异。植入材料的高弹性模量是不利的,因为其不会抑制在极端弯曲或扭转期间,特别是在高负荷峰值期间的冲击或突然增加的椎间盘内压。所植入的椎间盘材料和邻近组织之间的弹性模量的巨大差异还能够导致椎骨端板和邻近骨(spongeosus)的软化,从而导致髓核植入体的下沉。植入体的移动和排出也能够发生。
因此,需要一种改进的髓核植入体。
发明内容
本发明的示例性实施例的目的是提供一种制造用于多腔室髓核植入体的弹性壳体的方法,其能够选择性地和可控地用提供与正常椎间盘类似的物理和机械特性的材料进行充气和放气,并且能够针对个体患者参数进行调整。
本发明的示例性实施例的另一目的是提供一种制造髓核植入体的方法,该髓核植入体能够经皮置入到椎间盘腔中并且膨胀以符合椎间盘腔的形状和大小。
本发明的示例性实施例的另一目标是提供一种髓核植入体,该植入体在其被撕裂的情况下能够加强纤维环。
根据示例性实施例,一种可植入的假体装置包括具有第一开口的可膨胀的内壳体和具有第一开口的可膨胀的外壳体。可膨胀的外壳体封装可膨胀的内壳体。阀组件密封地耦合可膨胀的外壳体的第一开口和可膨胀的内壳体的第一开口,并且阀组件被配置为允许可膨胀的外壳体和可膨胀的内壳体独立膨胀。围绕可膨胀的外壳体的周边提供环形加强带。当植入时,内腔室填充有可压缩材料并且可膨胀的外壳体填充有原位可固化材料,例如硅树脂。这种结构允许施加在植入体的垂直和水平负载应力被向内、中心地重定向为朝向内部可压缩壳体而不是向外。
可膨胀的内壳体和可膨胀的外壳体可包括无缝的整片的材料。可膨胀的内壳体可以具有通常与第一开口相对的第二开口,可膨胀的外壳体可以具有通常与第一开口相对的第二开口,并且塞子可以密封地耦合可膨胀的内壳体的第二开口和可膨胀的外壳体的第二开口。塞子可以耦合到可膨胀的外壳体的第二开口的颈部。塞子和可膨胀的外壳体的第二开口的颈部可以耦合到可膨胀的内壳体的第二开口的颈部。
环形加强带可以布置在可膨胀的内壳体的第二开口内,然后远端塞子可以***到第二开口内以将加强带耦合到球囊。加强带可以仅在一个位置(例如塞子处)处耦合到可膨胀壳体。可以提供紧固件来将加强带紧固到塞子。加强带可以包含形状记忆材料。环形加强带可以包括围绕形状记忆材料的管状编织物。
阀组件可以包括耦合可膨胀的外壳体的第一开口和可膨胀的内壳体的第一开口的阀芯。阀芯具有从阀芯内部到阀芯外部的开口。阀膜部分地包围阀芯并且具有进入可膨胀的外壳体的开口。阀膜和阀芯中的开口是彼此分离的以允许材料流入到可膨胀的外壳体,同时防止回流。阀芯可以进一步包括可重封的、可刺穿的膜以提供到可膨胀的内壳体的通路。
阀膜和阀芯可以被整体模制,或者阀芯可以通过粘合剂粘合到阀膜。
可膨胀的内壳体和可膨胀的外壳体可以包括诸如硅橡胶之类的弹性体。
在一些实施例中,可固化材料以使可膨胀的外壳体膨胀,并且可以提供诸如气体之类的可压缩材料以使可膨胀的内壳体膨胀以允许固化的材料变形。固化的材料可以基本上包围可膨胀的内壳体。在其他实施例中,不可压缩材料(例如液体)用于膨胀可膨胀的内壳体,然后将固化的材料注入到可膨胀的外壳体。不可压缩材料然后从可膨胀的内壳体移除并且替换为可压缩材料(例如气体)。在某些实施例中,可固化材料进一步与可膨胀的内壳体和可膨胀的外壳体聚合以形成固体的整体构件。
根据实例性实施例,用于膨胀包括连接到可膨胀的外壳体的可膨胀的内壳体的可植入的假体装置的阀组件,该阀组件包括弹性膜和阀芯,该弹性膜形成从可膨胀的内壳体的内部到可膨胀的外壳体的外部的通道,并且该阀芯布置在通道中以使得弹性膜包围阀芯。弹性膜具有进入可膨胀的外壳体内部的开口,并且弹性膜包围阀芯。阀芯包括从第一端延伸到第二端的导管以及位于用于提供到可膨胀的内壳体的可重封的通道的阀芯导管的第二端处的可重封的、可刺穿的膜。导管中的开口从导管内部延伸到导管外部,并且阀芯中的开口偏离弹性膜中的开口以形成单向阀,从而允许引入到导管内部的材料进入到可膨胀的外壳体的内部,同时防止回流。
根据示例性实施例,一种将假体装置植入到具有被纤维环包围的髓核的椎间隙的方法,该方法包括穿透纤维环,移除髓核,并且植入可植入的假体装置,其中可植入的假体装置包括具有第一开口的可膨胀的内壳体和具有第一开口的可膨胀的外壳体。可膨胀的外壳体封装可膨胀的内壳体。阀组件密封地耦合可膨胀的外壳体的第一开口和可膨胀的内壳体的第一开口,并且阀组件被配置为允许可膨胀的外壳体和可膨胀的内壳体独立膨胀。围绕可膨胀的外壳体的周边提供加强带。
在一些实施例中,该方法可以进一步包括:使用可压缩材料使可膨胀的内壳体膨胀,并且可压缩材料可以包括气体。该方法可以进一步包括使用可固化材料使可膨胀的外壳体膨胀,并且可固化材料可以是硅橡胶。在其他实施例中,所述方法可以进一步包括使用不可压缩材料使可膨胀的内壳体膨胀,并且不可压缩材料可以包括液体。该方法可以进一步包括使用可固化材料使可膨胀的外壳体膨胀,从而允许可固化材料固化,并且将可膨胀的内壳体中的不可压缩材料替换为可压缩材料。
根据示例性实施例,制造可植入的假体装置的方法包括:(i)注塑模制假体坯件,该假体坯件包括具有近端和远端的外膜部分、具有近端和远端的内膜部分、布置在外膜部分近端和内膜部分近端之间的阀部分、位于内膜部分远端处的远端塞子内部部分以及位于外膜部分远端处的远端塞子外部部分;和(ii)部分地反转假体坯件使得外膜部分围绕内膜部分以形成包围由内膜形成的内球囊的外球囊。
根据示例性实施例,制造可植入的假体装置的方法包括(i)提供具有构造成为形成假体坯件成型外表面的心轴,该假体坯件包括具有近端和远端的外膜部分、具有近端和远端的内膜部分、布置在外膜部分近端和内膜部分近端之间的阀部分、位于内膜部分远端处的远端塞子内部部分以及位于外膜部分远端处的远端塞子外部部分;(ii)用材料浸涂心轴以形成假体坯件;(iii)从心轴剥离假体坯件;和(iv)部分地反转假体坯件使得外膜部分包围内膜部分以形成围绕由内膜形成的内球囊的外球囊。
心轴可以包括整件本体,并且心轴的阀部分可以包括与假体坯件整体模制的阀芯。心轴可以包括耦合到阀芯的两个分离的块,并且从心轴剥离假体坯件的步骤可以包括从阀芯分离心轴块以及从假体坯件移除分离的块。
阀芯可以粘合到阀部分内。
远端塞子可以***到远端塞子外部部分以密封远端塞子外部部分,并且远端塞子和远端塞子外部部分可以***到远端塞子内部部分。
加强带可以连接到远端塞子,并且加强带、远端塞子和远端塞子外部部分可以***到远端塞子内部部分。利用紧固件可以将加强带连接到远端塞子。
可以通过将心轴浸入到聚合物液体(可以包括硅树脂分散液)中来对心轴进行涂覆,并且干化。
可以通过熔化心轴来将弹性膜从心轴剥离,或者可以通过在心轴上拉伸假体坯件将假体坯件从心轴移除。可以围绕外球囊周边施加加强带。
根据示例性实施例,一种用于制造可植入的假体装置的心轴包括:具有配置为第一球囊形状的成型外表面的第一球囊心轴;具有配置为第二球囊形状的成型外表面的第二球囊心轴;以及布置在第一和第二球囊心轴之间的阀芯。第一球囊心轴的外表面可以进一步包括远端开口部分,并且第二球囊心轴的外表面可以进一步包括远端开口部分。球囊心轴的外表面可以是弯曲的。每个球囊心轴的外表面都可以包括直径大致相同的中心部分。
根据示例性实施例,一种用于制造可植入的假体装置的心轴包括具有成型外表面的整体。成型外表面具有:外膜部分,其构造成形成具有近端和远端的环形球囊;内膜部分,其构造成形成具有近端和远端的核球囊;阀部分,其构造成接收设置在外膜部分的近端和内膜部分的近端之间的阀组件;远端塞子外部部分,其构造成在所述外膜部分的远端处接收远端塞子;以及远端塞子内部部分,其构造成在所述内膜部分的远端处接收远端塞子和远端塞子外部部分的组合。
术语“耦合”限定为连接,尽管未必直接连接。除非本公开另外明确地要求,术语“一种”和“一个”限定为一个或更多个。如本领域普通技术人员所理解的,术语“基本上”、“大约”、“约”限定为所指的大部分而非全部(并且包括所指的;例如基本上90度包括90度以及基本上平行包括平行)。在任何公开的实施例中,术语“基本上”、“大约”和“约”可以用“在(百分比)内”来代替,其中所指百分比包括0.1%、1%、5%、和10%。
术语“包括”、“具有”、“包含”和“含有”是开放式连系动词。因此,“包括”、“具有”、“包含”或“含有”一个或更多个元件或特征的***或***的组件拥有所述一个或更多个元件或特征,但不限于仅拥有所述元件或特征。同样地,“包括”、“具有”、“包含”或“含有”一个或更多个步骤的方法拥有所述一个或更多个步骤,但不限于仅拥有所述一个或更多个步骤。此外,诸如“第一”和“第二”之类的术语仅用于区分结构或特征,而不是将不同的结构或特征限制到特定的顺序。
按一定方式配置的任一装置、***或组件至少以那种方式配置,但其也能够以除了具体描述的方式之外的其他方式来配置。
任何***和方法的任何实施例能够由所描述的元件,特征和/或步骤中的任何一个组成或基本上由-而不是包括/包括/包含/具有-所描述的元件,特征和/或步骤中的任何一个。因此,在任一权利要求中,术语“组成”或“基本上组成”能够代替上述的任何开放式连系动词,以便改变使用开放式连系动词得到的给定权利要求的范围来改变所给权利要求的范围。
即使没有描述或说明,一个实施例的特征或多个特征可以应用到其他实施例,除非本公开或实施例的性质明确禁止。
下面给出与上述实施例相关联的细节和其他细节。
附图说明
图1是根据本发明实施例的充了气的植入体的透视图;
图2是图1的充了气的植入体从另一方向的透视图;
图3是图1的植入体的俯视图;
图4是通过图3中的线4-4截取的截面图;
图5是通过图3中的线5-5截取的截面图;
图6是图1的植入体的植入阀的一部分的截面图;
图7是图6的植入阀的一部分的截面图;
图8是在***远端塞子和环形加强构件的附接件之前的植入体组件的截面图;
图9是根据本发明实施例的心轴和植入体的截面图;
图10图示了图1的植入体组件的第一组装步骤;
图11图示了图1的植入体组件的第二组装步骤;
图12图示了图1的植入体组件的第三组装步骤;
图13图示了图1的植入体组件的第四组装步骤;
图14是根据本发明另一实施例的心轴和植入体组件的截面图;
图15图示了图1的植入体组件的第一组装步骤;
图16图示了图1的植入体组件的第二组装步骤;
图17图示了图1的植入体组件的第三组装步骤;
图18图示了图1的植入体组件的第四组装步骤;
图19图示了图1的植入体组件的最终装步骤;
图20图示了植入图1的植入体组件的第一步骤;
图21图示了植入图1的植入体组件的第二步骤;
图22图示了植入图1的植入体组件的第三步骤;和
图23图示了植入图1的植入体组件的第四步骤。
具体实施方式
在以下详细描述中,参考附图,其中示出了本发明的示例性但非限制性和非穷举性的实施例。对这些实施例进行充分详细的描述,以使本领域技术人员能够实践本发明,并且可以理解,在不脱离本发明的精神或范围的情况下,可以使用其他实施例并且可以做其他改变。因此,以下详细描述不被认为是限制性的,并且本发明的范围仅由所附权利要求限定。在附图中,除非另有说明,相同的附图标记表示各个附图中的相同部件。
植入体的描述
参照图1-8,可经皮输送的脊椎植入体100的实施例包括可膨胀的外壳体(或球囊)102和可膨胀的内壳体(或球囊)104。可膨胀的外壳体102形成环形腔室106,并且可膨胀的内壳体104形成核腔室108。核腔室108封装在环形腔室106内。优选地,可膨胀的外壳体102和可膨胀的内壳体104形成为无缝的、整件弹性材料(诸如硅橡胶)。使用弹性材料产生柔性的外球囊102和内球囊104。即,当施加内压力时外球囊102和内球囊104会膨胀。使用柔性球囊提供了某些优势。柔性的球囊适应核空间的不规则、扁平的或圆盘状结构。此外,柔性球囊在弹性体固化之后保持髓核植入体的合适的弹性模量,并且保留脊椎部分的生物-机械移动性,并且允许固化的硅树脂组件不受阻碍地变形为中空的。
环形加强带110可以围绕植入体100的侧棱的周界布置,以最小化或防止弹性膜的过度拉伸、或外球囊102和内球囊104的过度周向膨胀。环形加强带110促进垂直扩张以加宽椎间隙。上级椎骨端板和下级椎骨端板约束了植入体100的扩张。
植入体100的大小是选定的,使得其能够经皮***到去核的椎间盘间隙内,同时放气然后膨胀以填充去核的腔。在一个实施例中,充了气的植入体100的外部大约为长30mm,宽20mm,高10mm,并且可膨胀的内壳体104的外部大约为长9mm,宽6mm,厚6mm。
环形加强带110可以是生物相容的纺织材料。在一个实施例中,环形加强带110包括管状的编织纺织材料。环形加强带110还可以包含可膨胀构件以提供额外的支撑。可膨胀构件可以由形状记忆材料例如镍钛诺形成。题为“Percutaneous Implantable NuclearImplant”的美国专利号8636803公开了环形加强带110的合适的结构,为了所有目的,其全部内容通过引用并入本文。
可膨胀的外壳体102具有第一开口118和第二开口120。可膨胀的内壳体104具有第一开口136和第二开口138。近端塞子或阀芯112连接第一开口118和第一开口136。阀膜122围绕近端塞子112并与近端塞子112一起形成膨胀阀124。膨胀阀124是单向阀,其允许材料被引入到环形腔室106内。优选地,如下面进一步详细地描述的,阀膜122由可膨胀的外壳体102和可膨胀的内壳体104整体形成。在图6-8中显然可见,近端塞子112包括从第一端128延伸到第二端130的导管126。近端塞子112的第一端128形成用于容纳膨胀触笔116的端口114。阀膜122通过基本上是流体密封的第一和第二粘合带140、142耦合到近端塞子112。在第一粘合带140和第二粘合带142之间的阀膜122的部分是非粘合的以形成用于允许材料经由其流动的通道。至少一个开口132从导管126延伸到近端塞子112的外部。阀膜122具有偏离开口132的至少一个开口134。以这种方式,当合适的材料(以下详细地描述)在压力下被引入到导管126内时,材料被通过开口132引入到环形腔室106内,扩张阀膜122,并通过开口134流出。当压力从导管126移除时,阀膜122密封开口132并且防止通过开口132回流。导管126的第二端130被可刺穿的、可重封的膜144关闭。
远端塞子146布置在从可膨胀的内壳体104的第二开口138延伸出的颈部148中。远端塞子146连接到颈部148以形成流体紧密封。远端塞子146和颈部148的组件布置在从可膨胀的外壳体102的第二开口120延伸的颈部150中。环形加强带110可以被限制在远端塞子146和颈部148组件以及颈部150之间以作为加强带110的锚。可选地,如图9中清楚的所示,可以使用紧固件152来将加强带110锚定到远端塞子146。
制造植入体的方法
参照图9-13,在一个实施例中,可膨胀的外壳体102和可膨胀的内壳体104由整件的植入体坯件154形成。植入体坯件154可以通过使用心轴156来浸渍模制制成。心轴156包括外膜部分158,内膜部分160和阀部分162。心轴156可以是一片或多片。在一个实施例中,外膜部分158、内膜部分160和阀部分162是组装在一起的分离的片。心轴156浸在聚合物液体中,例如硅树脂分散液,从液体中移出并使其干燥或固化。可以将心轴156浸入一次或更多次以形成所需厚度的材料。坯件154包括颈部150、可膨胀的外壳体102、阀膜122、可膨胀的内壳体104和颈部148。
固化或干燥之后,植入体坯件154从心轴156剥离。这可以通过拉伸在心轴156上的植入体坯板154来实现。如果心轴156由可分离的片组成,其可以在剥离前被拆开。在一个实施例中,心轴156可以由可熔或可溶材料形成,并且熔化或溶化以从心轴156剥离植入体坯件154。在植入体坯件154中形成穿过阀膜122的开口134。
参照图10-13,提供了植入体坯件154、远端塞子146和近端塞子(或阀芯)112。从可膨胀的内壳体104延伸出的颈部148被反转进入可膨胀的内壳体104的内部,并且远端塞子146***到颈部148内并粘合到位。颈部被进一步反转进入环形腔室106内。然后,近端塞子112***并粘合到阀膜122内。这分两个步骤完成。首先,利用第一粘合带140将离环形腔室106最近的近端塞子112的末端粘合到阀膜122。其次,将植入体坯件154进一步反转,并且利用第二粘合带142将植入体坯件154粘合到近端塞子112的第二末端。这导致了图12示出的配置。如图13所示,然后,颈部150被塞入可膨胀的外壳体102内(如图8中的箭头所示)并且位于远端塞子146和颈部148之上。环形加强带110可以同时塞入或通过紧固件固定到远端塞子146。
在另一实施例中,通过使用常规技术在心轴上注塑模制来形成植入体坯件154。即,将心轴布置在具有对应于植入体坯件外部形状的腔的注塑模具内,并且在压力下将可固化材料注入到模具内。使可固化材料固化,从而在心轴上形成植入体坯件154。然后从注塑模具内移除心轴和植入体坯件154。一旦形成植入体坯件154,剩余的组装步骤如前所述。
图14-19图示了制造植入体100的另一种方法。在该实施例中,心轴164包括形成外膜部分158的第一心轴部分166和形成内膜部分170的第二心轴部分168。第一心轴部分166***到阀芯(或近端塞子)112内,并且第二心轴部分与近端塞子112的另一端紧密配合。参照图15,然后将心轴和阀组件浸渍成型以形成植入体坯件176。参照图16,将植入体坯件176的颈部188反转并且将近端塞子粘合到颈部188。将阀膜192施加到塞子部分上,并且利用第一和第二粘合带将阀膜192粘合到塞子部分以形成植入阀。如图18所示,然后将植入体坯件176相对于阀芯112从左到右反转。最后,将颈部190塞入可膨胀的外壳体102内。环形加强带110可以同时塞入或通过紧固件固定到远端塞子146。
植入体的置入方法
参照图20-23,可膨胀植入体100特别适合于使用微创技术或经皮外科技术来置入。为准备用于置入的可膨胀植入体100,将植入体放气并拉伸以最小化其横截面轮廓。***探针116可拆卸地***到端口114内,然后将植入体100***到置入套管180内。置入套管180具有最小的横截面轮廓。
参照图20,为植入可膨胀植入体100,通过进行椎间盘切除术而基本上完整地保留纤维环178来移除现有的髓核。优选地,使用微创外科技术(例如经皮技术)来进行椎间盘切除术,其会留下穿过纤维环178的小开口。一旦髓核被移除,纤维环178和椎骨端板182、184形成基本上是空的椎间盘腔182。
在髓核被移除之后,将具有预先装入的植入体100的置入套管180放置到空的椎间盘腔182内。如图21所示,通过将植入体推出置入套管并推入空的椎间盘腔来置入植入体100。植入体100处于未膨胀状态。
在一个实施例中,首先利用可压缩流体194(例如气体)使核腔室108膨胀。这可以使用通过膨胀触笔116输送的并被推过可刺穿的、可重封的膜144的针(未示出)来执行。将可压缩流体置入到核腔室108内以膨胀可膨胀的内壳体104。核腔室108的压力是选定的,以便其在负重和脊椎运动期间为固化的弹性体186的内部变形提供缓冲区。一旦核腔室108膨胀到期望的压强,针从核腔室108撤出。在另一实施例中,代替可移除的针,膨胀触笔116可以具有延伸穿过探针的隔膜以将探针分成两个腔。一个腔延伸穿过可重封的、可刺穿的膜144进入核腔室108,而另一个腔将原位可固化材料输送到植入阀124和环形腔室106。
膨胀触笔116被用于通过单向植入阀124(图22)将原位可固化材料输送到环形腔室106。可固化材料优选为诸如硅橡胶之类的弹性材料,其与可膨胀的内壳体102和可膨胀的外壳体104的材料进一步聚合以形成整体构件。可固化材料的弹性模量和其他特征能够基于病人的具体参数来选择。例如,年轻的、更活跃的病人可能比较少移动的老年病人需要更坚固的材料。一旦环形腔室106膨胀到期望的压强,膨胀触笔116能够被移除。植入阀124防止可固化材料从环形腔室106泄漏。
在可固化材料被允许固化之后,植入体100包括围绕核腔室108的固化的弹性体186的环孔,该核腔室填充有可压缩材料194。这种结构允许施加在椎间盘间隙的垂直和水平负载应力被向内、中心地重定向为朝向核腔室108(参见图23的方向箭头)而不是向外。此外,环形加强带110促进原生纤维环178的组织向内生长,从而对原生纤维环178提供加强。
在另一实施例中,首先利用诸如液体之类的不可压缩流体使核腔室108膨胀。如上所述,这可以使用针或膨胀触笔来进行。一旦核腔室194被膨胀,膨胀触笔116被用于通过单向植入阀124将原位可固化材料输送到环腔室106。在固化材料被允许固化之后,不可压缩流体从核腔室108移除并且替换为可压缩材料194。这可以通过使用植入阀124的针来实现。
上述说明书和示例提供了示例性实施例的结构和用途的完整描述。虽然上面已经以某种程度的特殊性或者参考一个或多个单独的实施例来描述了某些实施例,但是本领域的技术人员能够在不脱离本发明范围的情况下对所公开的实施例做出许多改变。本装置的各个示例性实施例不旨在限于公开的具体形式。相反,所述各个实施例包括落在权利要求范围内的所有修改和替换,并且除了所示的实施例,实施例可以包含所描述实施例的一些或全部特征。例如,组件可以结合为整体的结构,和/或连接可以被取代(例如,螺纹可以用压配件或焊缝代替)。此外,在适当的情况下,上述任何示例的方面可以与所描述的任何其它示例的方面组合以形成具有相当或不同性质的进一步示例并解决相同或不同的问题。同样地,可理解为上述利益和优势可以涉及一个实施例或可以涉及数个实施例。
除非在给定的权利要求中分别使用词组“用于……的装置”或“用于……的步骤”明确地陈述了这样的限制,否则权利要求不旨在包括并且不应被解释为包括装置+功能或步骤+功能的限制。
Claims (25)
1.一种制造可植入的假体装置的方法,包括:
形成假体坯件,所述假体坯件包括:
具有近端和远端的外膜部分,
具有近端和远端的内膜部分,
布置在所述外膜部分的近端和所述内膜部分的近端之间的阀部分,
位于所述内膜部分的远端处的远端塞子内部部分,以及
位于所述外膜部分远端处的远端塞子外部部分;
部分地反转所述假体坯件使得所述外膜部分包围所述内膜部分,使得所述外膜形成包围由所述内膜形成的内球囊的外球囊。
2.根据权利要求1所述的方法,其中,所述假体坯件通过注塑模制形成。
3.根据权利要求1至2之一所述的方法,进一步包括:将阀芯粘合到所述阀部分中。
4.根据权利要求1至3之一所述的方法,进一步包括:将远端塞子***到所述远端塞子外部部分以密封所述远端塞子外部部分。
5.根据权利要求4所述的方法,进一步包括:将所述远端塞子和远端塞子外部部分***到所述远端塞子内部部分。
6.根据权利要求4至5之一所述的方法,进一步包括:
将加强带连接到所述远端塞子;
将所述加强带、远端塞子和远端塞子外部部分***到所述远端塞子内部部分。
7.根据权利要求6所述的方法,其中,利用紧固件将所述加强带连接到所述远端塞子。
8.根据权利要求1至7之一所述的方法,进一步包括:围绕所述外球囊周边施加加强带。
9.一种可植入的假体装置,包括:
具有第一开口的可膨胀的内壳体;
具有第一开口的可膨胀的外壳体,所述可膨胀的外壳体封装所述可膨胀的内壳体,其中,所述可膨胀的内壳体和所述可膨胀的外壳体包括整件材料;
阀组件,其密封地耦合到所述可膨胀的外壳体的第一开口和所述可膨胀的内壳体的第一开口,所述阀组件被配置为允许所述可膨胀的外壳体和所述可膨胀的内壳体独立膨胀;以及
围绕所述可膨胀的外壳体周边的加强带。
10.根据权利要求9所述的可植入的假体装置,其中,
所述可膨胀的内壳体具有大体与所述第一开口相对的第二开口;
所述可膨胀的外壳体具有大体与所述第一开口相对的第二开口;以及
塞子,其密封地耦合所述可膨胀的内壳体的第二开口和所述可膨胀的外壳体的第二开口。
11.根据权利要求10所述的可植入的假体装置,其中,所述塞子耦合到所述可膨胀的外壳体的第二开口的颈部。
12.根据权利要求11所述的可植入的假体装置,其中,所述塞子和所述可膨胀的外壳体的第二开口的颈部耦合到所述可膨胀的内壳体的第二开口的颈部。
13.根据权利要求10至12之一所述的可植入的假体装置,其中,所述加强带被塞入所述可膨胀的内壳体的第二开口。
14.根据权利要求10至13之一所述的可植入的假体装置,其中,所述加强带仅连接到所述塞子。
15.根据权利要求10至14之一所述的可植入的假体装置,进一步包括:用于将所述加强带紧固到所述塞子的紧固件。
16.根据权利要求9至15之一所述的可植入的假体装置,其中,所述加强带包括形状记忆材料。
17.根据权利要求16所述的可植入的假体装置,其中,所述加强带进一步包括包围所述形状记忆材料的管状编织物。
18.根据权利要求9至17之一所述的可植入的假体装置,其中,所述阀组件包括:
阀芯,其具有从所述阀芯内部到所述阀芯外部的开口;
阀膜,其耦合所述可膨胀的外壳体的第一开口和所述可膨胀的内壳体的第一开口,所述阀膜部分地包围所述阀芯并且具有进入所述可膨胀的外壳体的开口,其中,所述阀膜中的开口和所述阀芯中的开口是彼此分离的。
19.根据权利要求18所述的可植入的假体装置,其中,所述阀芯进一步包括用于进入所述可膨胀的内壳体的可重封的、可刺穿的膜。
20.根据权利要求18至19之一所述的可植入的假体装置,其中,所述阀膜和所述阀芯是整体模制的。
21.根据权利要求18至19之一所述的可植入的假体装置,其中,利用粘合剂将所述阀芯粘合到所述阀膜。
22.根据权利要求9至21之一所述的可植入的假体装置,其中,所述可膨胀的内壳体和所述可膨胀的外壳体包括弹性体。
23.根据权利要求9至22之一所述的可植入的假体装置,进一步包括:
固化的硅树脂材料,其使所述可膨胀的外壳体膨胀;以及
可压缩气体,其使所述可膨胀的内壳体膨胀以允许所述固化的硅树脂材料变形。
24.根据权利要求23所述的可植入的假体装置,其中,所述固化的硅树脂材料基本上围绕所述可膨胀的内壳体。
25.根据权利要求23至24之一所述的可植入的假体装置,其中,所述固化的硅树脂材料还与所述可膨胀的内壳体和所述可膨胀的外壳体聚合以形成固体构件。
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US20240099854A1 (en) | 2024-03-28 |
EP3215067B1 (en) | 2020-06-10 |
CN106999286B (zh) | 2019-08-16 |
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US10314714B2 (en) | 2019-06-11 |
CA2966748C (en) | 2023-03-21 |
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US11638649B2 (en) | 2023-05-02 |
CA2966748A1 (en) | 2016-05-12 |
AU2015343171A1 (en) | 2017-06-22 |
US20160120653A1 (en) | 2016-05-05 |
KR20170097022A (ko) | 2017-08-25 |
AU2015343171B2 (en) | 2020-08-06 |
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