CN110740712A - 用于装载支架和人工心脏瓣膜的卷曲装置 - Google Patents
用于装载支架和人工心脏瓣膜的卷曲装置 Download PDFInfo
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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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
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Abstract
本文公开了用于卷曲医疗设备的系统和装置以及相关方法。根据本技术的实施方案配置的卷曲装置可以包括例如框架、可移动构件和多个叶片,所述框架包括固定板,所述叶片被布置为形成通道,并且每个叶片包括穿过可移动构件上的槽和固定板上的相应槽突出的销。卷曲装置可被驱动以相对于固定板移动可移动构件,使得沿着由槽限定的路径驱动销,从而径向向内驱动叶片以卷曲位于通道内的医疗设备。
Description
技术领域
本技术大体上涉及用于减小医疗设备尺寸的设备、系统和方法。具体而言,本技术的一些实施方案涉及用于减小人工心脏瓣膜装置尺寸的紧凑卷曲装置。
背景技术
可以通过经皮导管插入术将诸如支架和人工瓣膜装置的医疗设备引入身体血管腔中。这些医疗设备可以从允许经皮装置输送的第一横截面尺寸扩展到治疗部位的第二横截面尺寸。在扩张状态下,医疗设备的横截面尺寸大于用于输送医疗设备的导管。因此,卷曲装置通常用于卷曲(即,减小)医疗设备的横截面尺寸,使得医疗设备能够被装载到导管中并前进到体内的治疗位置。在治疗位置,医疗设备可以从导管中取出并扩张(例如,通过自扩张、气囊导管扩张或机械扩张装置),以提供治疗功能。
相对于通过经皮导管插入术输送的其它医疗设备(例如,支架),人工心脏瓣膜装置(例如,人工二尖瓣装置)在扩张状态下可以具有大的横截面尺寸。例如,一些人工二尖瓣可以具有1.97英寸或更大的扩张横截面尺寸。通常需要包装和储存处于扩张状态的人工心脏瓣膜装置,直到植入患者体内。例如,人工心脏瓣膜装置可以储存在无菌溶液中,直到人工心脏瓣膜装置准备好装载到用于植入的输送系统中。因此,通常希望在手术室中卷曲人工心脏瓣膜装置,并且仅在植入人工心脏瓣膜装置的过程的前几分钟卷曲。这种工序避免了制造商的预卷曲,并且受益于高度便携且易于用作无菌系统的卷曲设备。
附图说明
参考以下附图可以更好地理解本公开的诸多方面。附图中的组件不一定按比例绘制。相反,重点在于清楚地说明本公开的原理。此外,为了清楚起见,组件可以在某些视图中显示为透明的,而不是为了表示所示组件必须是透明的。这里提供的标题只是为了方便。
图1是用于减小医疗设备尺寸的系统的等距视图,该系统根据本技术的一些实施方案配置。
图2和图3是图1的系统的卷曲装置的等距视图,该装置根据本技术的实施方案的分别处于第一位置和第二位置。
图4是图2和3所示卷曲装置的局部分解图。
图5是图2-4所示的卷曲装置的叶片的等距视图,该叶片根据本技术的一些实施方案配置。
图6是可释放地耦合到人工心脏瓣膜装置的一部分的医疗设备保持器的等距视图,该保持器根据本技术的一些实施方案的与图1所示系统一起使用。
图7和8分别是耦合到图2-4的卷曲装置的图6的医疗设备保持器的等距视图和横截面视图,其根据本技术实施方案示出。
图9是图1系统的托盘的俯视图,该系统托盘根据本技术的多种实施方案配置。
具体实施方式
本技术大体上涉及包括卷曲装置的系统,用于减小人工心脏瓣膜装置和其它医疗设备的尺寸。术语“卷曲”(例如,与卷曲装置或卷曲方法相关的使用)可以指将医疗设备压紧或压紧到较小尺寸的装置和方法。这里参考图1-9描述了本技术的几个实施方案的具体细节。尽管许多实施方案是关于用于将人工心脏瓣膜装置卷曲、装载和输送到天然二尖瓣的装置、系统和方法来描述的,但是除了在此描述的那些之外,其它应用和其它实施方案也在本技术的范围内。例如,本技术的至少一些实施方案可用于将假体输送至其它天然瓣膜,例如三尖瓣或主动脉瓣。应当注意,除了在此公开的实施方案之外,其它实施方案也在本技术的范围内。此外,本技术的实施方案可以具有不同于在此示出或描述的配置、组件和/或过程。此外,本领域普通技术人员将理解,除了这里所示或所述的那些之外,本技术的实施方案可以具有配置、组件和/或过程,并且这些和其它实施方案可以没有这里所示或所述的几个配置、组件和/或过程,而不偏离本技术。
关于本说明书中的术语“远端”和“近端”,除非另有说明,这些术语可以指人工瓣膜装置和/或相关输送装置的部分相对于操作者和/或血管系统或心脏中的位置的相对位置。例如,在提及适于输送和定位本文所述的各种人工瓣膜装置的输送导管时,“近端”可以指更靠近装置操作者的位置或进入血管系统的切口,“远端”可以指沿着血管系统更远离装置操作者或更远离切口的位置(例如,导管的端部)。
概述
图1示出了根据本技术的用于减小医疗设备尺寸的卷曲和装载系统10(“系统10”)的实施方案。具体而言,系统10可用于卷曲或压紧医疗设备,以使医疗设备能够装载到输送系统中,用于将医疗设备经皮输送给患者。在一些实施方案中,医疗设备可以是人工心脏瓣膜设备。更具体地,医疗设备可以是用于植入天然二尖瓣的二尖瓣装置,并且输送系统可以是用于将二尖瓣装置输送至天然二尖瓣的输送系统,例如在(1)2014年3月14日提交的PCT/US2014/029549号国际专利申请,(2)2012年10月19日提交的PCT/US2012/061219号国际专利申请,(3)2012年10月19日提交的PCT/US2012/061215号国际专利申请(4)2012年6月21日提交的PCT/US2012/043636号国际专利申请,(5)2017年4月18日提交的15/490,047号美国专利申请,以及(6)2017年4月18日提交的15/490,008号美国专利申请,上述每项均通过引用全部结合于此。
如图1所示,系统10包括卷曲装置100、医疗设备保持器200(“保持器200”)、托盘300和支架400。卷曲装置100包括多个叶片(不可见;下面将进一步详细描述),其限定了通道115和驱动部件105,通道115被配置为接收处于扩张状态的医疗设备,驱动部件105可操作地连接到叶片。使用者可以操纵驱动部件105来改变或减小通道115的横截面尺寸(例如直径),从而减小位于通道115内的医疗设备的外部尺寸。在一些实施方案中,保持器200可释放地连接到医疗设备,然后可拆卸地连接到卷曲装置100的入口侧101,使得保持器200在卷曲之前和/或卷曲期间将医疗设备适当地定位于卷曲装置100的通道115内。
如图1所示,卷曲装置100可以至少部分地位于托盘300中的储存器310内。在一些实施方案中,托盘300包括多个凸缘305,凸缘305突出到储存器310中,并限定凹槽315,凹槽315的尺寸和形状适于保持卷曲装置100,使得通道115位于储存器310内。在其它实施方案中,托盘300可以包括用于将卷曲装置100保持和适当定位于托盘300内的不同或附加特征,例如紧固件、互锁表面和/或其它适当的保持特征。当卷曲装置100位于凹槽315内时,储存器310可以容纳浸没通道115的液体(例如,冷冻盐水)。如图1进一步所示,托盘300还可以包括孔320,用于通过其接收输送系统600的一部分,并且便于将卷曲的医疗设备装载到输送系统600中。例如,输送系统600的细长导管体605和/或输送胶囊610可以通过孔320插入,并且位于卷曲装置100的出口侧103上的通道115附近。在一些实施方案中,托盘300可进一步包括一个或多个位于孔320内的密封构件(未示出),以在输送系统移入和移出储存器310时至少部分地密封储存器310内的液体。支架400可以定位为支撑导管主体605的一部分和/或使输送系统600与托盘300的孔320对准。在其它实施方案中,系统10可以包括附加组件或者可以省略一些特征。
在操作中,卷曲装置100位于托盘300的凹槽315内。当医疗设备处于其扩张状态(例如,无约束状态)时,医疗设备,例如人工心脏瓣膜装置,可释放地连接到保持器200,然后保持器200连接到卷曲装置100的入口侧101,使得医疗设备延伸到通道115中。在一些实施方案中,在卷曲装置100位于托盘300的凹槽315内之前,保持器200附接到卷曲装置100的入口侧101。在一些实施方案中,医疗设备可以与保持器200一起包装并预先附接到保持器200。在一些实施方案中,省略了保持器200,并且医疗设备可以自身放置在通道115中和/或可释放地附接到卷曲装置100的另一部分,以将医疗设备保持在通道115中。在医疗设备位于通道115中之前或之后,托盘300的储存器310可以填充液体(例如,冷冻盐水),使得卷曲装置100的通道115和位于其中的医疗设备浸没在液体中。当卷曲装置100作用在医疗设备上以减小医疗设备的外部尺寸时,浸没医疗设备可以保持医疗设备冷却。
当系统10用于便于将装置装载到输送系统600中时,导管体605的远端部分可以通过孔320定位,使得导管体605远端处的输送胶囊610位于卷曲装置100的出口侧103,邻近通道115。在一些实施方案中,输送胶囊610的远端鼻状锥(nose cone)和附接到其上的细长中心轴至少部分地通过通道115和不受约束的医疗设备插入(例如,朝向卷曲装置100的入口侧101,超过医疗设备的远端)。支架400可定位为将导管主体605和/或输送系统600的其它部分支撑在托盘300外部,并将输送系统600与托盘300的孔320和卷曲装置100的通道115对准。
一旦输送系统600和医疗设备相对于卷曲设备100准确就位,用户可以操纵卷曲设备100的驱动部件105以减小通道115的横截面尺寸,从而减小医疗设备的外部尺寸(即,“卷曲”医疗设备)。在一些实施方案中,医疗设备被卷曲以适应输送胶囊610的尺寸,用于将微创工序植入医疗设备。在一些实施方案中,减小通道115的横截面尺寸使保持器200与医疗设备脱离,使得医疗设备不再附接到保持器200,使医疗设备之后从通道115(例如,经由卷曲装置100的出口侧103或入口侧101)移除。
一旦医疗设备卷曲,医疗设备就可以被装载到输送系统600中,随后用于输送给患者。例如,输送系统600的一部分可以被配置为接合医疗设备并将卷曲的医疗设备拉入输送胶囊610和/或导管主体605中。在一些实施方案中,输送系统600的活塞装置与医疗设备的特征接合,然后缩回以将医疗设备拉入输送胶囊610中。在一些实施方案中,卷曲装置100的通道115具有大致漏斗状的形状,其中通道115的直径沿着从入口侧101到出口侧103(即,远离保持器200并朝向输送胶囊610)的轴线减小。在这样的实施方案中,当医疗器械从通道115的较宽直径部分被拉动并穿过通道115的较窄直径部分时,将医疗器械拉入输送胶囊610可以进一步卷曲医疗器械的一部分。在一些实施方案中,医疗设备被拉入输送系统600,同时浸没在储存器310内的液体中。这预期会在装载医疗设备时抑制气袋或气泡在输送系统600中成型。一旦医疗设备装载到输送系统600中,输送系统600就可以从托盘300中取出,并随后用于将医疗设备植入患者体内。在一些实施方案中,系统10被配置为完全一次性的系统。因此,系统10的各种部件,包括卷曲装置100,可以在医疗设备被装载到输送系统中之后被处理掉(与被清洁以便随后再次使用相比)。通过将系统10设置为一次性,系统10可以在每个工序之前提供新的无菌环境。
卷曲装置、医疗设备保持器和相关方法的选定实施方案
图2和3是图1的卷曲装置100的等距视图,其示出了处于第一位置和处于第二位置的卷曲装置100,其中处于第一位置的通道115具有第一横截面尺寸(图2),处于第二位置的通道115具有第二横截面尺寸(图3)。图4是图2的卷曲装置100的等距局部分解图(即,示出了处于第一位置的卷曲装置100)。在一些实施方案中,第一和第二横截面尺寸分别是最大和最小横截面尺寸。卷曲装置100包括框架110、多个可移动叶片140,所述可移动叶片140周向布置在框架110内以限定通道115,所述通道115具有延伸穿过其中的中心轴线107。
参考图4,框架110可以包括第一板120和第二板130(统称为“板120、130”),第一板120具有延伸穿过第一板120的部分的多个第一槽122,第二板130具有延伸穿过第二板130的部分的多个第二槽132。卷曲装置100还包括相对于第一和第二板120和130可移动(例如,可旋转)的第一可移动构件160和第二可移动构件170(统称为“可移动构件160、170”)。例如,可移动构件160、170可以被配置为围绕通道115的中心轴线107旋转。第一可移动构件160位于叶片140和第一板120之间,并且第一可移动构件160包括延伸穿过第一可移动构件160的部分的多个第三槽162。类似地,第二可移动构件170位于叶片140和第二板130之间,并且第二可移动构件170包括延伸穿过第二可移动构件170的部分的多个第四槽172。第一槽122的部分可以与第三槽162的部分对齐,第二槽132的部分可以与第四槽172的部分对齐。在一些实施方案中,第一和第二槽122和132(统称为“槽122、132”)以及第三和第四槽162和172(统称为“槽162、172”)关于垂直于通道115的中心轴线107延伸的平面反射对称(reflectively symmetric)。
每个叶片140可以包括销142,其从与中心轴线107间隔开的叶片140的一部分(例如,叶片140的外部)突出。在卷曲装置100的出口侧103,每个销142延伸穿过第一板120的第一槽122之一和第一可移动构件160的相应的第三槽162之一,并且在卷曲装置100的入口侧101,每个销142延伸穿过第二可移动构件170的第二槽132之一和相应的第四槽172之一。因此,每个板120、130和可移动构件160、170上的槽122、132、162、172的数量可以对应于叶片140的数量。在操作中,用户可以操纵驱动部件105来相对于第一和第二板120和130旋转、滑动或以其它方式移动第一和第二可移动构件160和170。这沿着由相应的槽122、132、162、172限定的路径驱动销142,从而径向向内驱动叶片140以减小通道115的横截面尺寸(图3)。叶片140的径向向内运动作用在位于通道115内的医疗设备(例如,人工心脏瓣膜装置)的外表面上,从而减小医疗设备的外部横截面尺寸(例如,直径),以配合在输送胶囊(例如,图1的输送胶囊610)内。在一些实施方案中,省略了第二板130和第二可移动构件170,使得仅使用第一板120和第一可移动构件160的相对运动即可驱动叶片140的向内运动。
板120、130可以具有大致矩形的形状,使得框架110具有大致矩形的横截面。在其它实施方案中,板120、130可以具有其它形状,例如圆形、六边形、多边形等。并且可以具有彼此不同的形状。例如,当板120、130具有圆形形状时,框架110可以包括稳定的底部区域。在一些实施方案中,板120、130可以是位于限定框架110的外壳内的内部部件。框架110可以具有被配置为紧密配合在托盘300的凹槽315(图1)内的形状。驱动部件105可以位于框架110的上表面112(图2)上,使得在卷曲过程中使用者可以方便地使用它。在其它实施方案中,驱动部件105可以位于框架110上的其它位置,或者可以是电动机而不是手动驱动器。如图4所示,板120、130相对于可移动构件160、170是固定的。在一些实施方案中,第一板120可相对于第一可移动构件160移动和/或第二板130可相对于第二可移动构件170移动,以径向向内驱动叶片140。例如,操纵驱动部件105可以在与第一可移动构件160相反的方向上旋转第一板120。
第一和第二槽122和132可以各自限定远离通道115的中心轴线径向延伸的直线路径。如图4所示,每个板120、130可以包括围绕通道115的中心轴线107以相等间隔隔开的十二个槽122、132。然而,在一些实施方案中,每个板120、130根据叶片140的数量可以包括少于或多于十二个槽(例如,六个槽、八个槽、十四个槽等),和/或槽122、132可以以其它配置布置,并且可以具有不同的形状。例如,槽122、132中的一个或多个可以限定大致弓形或其它路径。如图4所示,第二槽132可以具有与第一槽122大致相似的特征。在其它实施方案中,第二槽132可以具有与第一槽122不同的数量和/或具有不同的构造、形状等。
第一可移动构件160上的第三槽162可以各自限定弧形或成角度的路径,该路径具有第一端163a和第二端163b,第二端163b比第一端163a径向更靠近通道115的中心轴线。在一些实施方案中,第一可移动构件160包括围绕通道115的中心轴线107以相等间隔彼此隔开的十二个弧形槽162。在其它实施方案中,根据叶片140的数量,多个第三槽162可以包括少于或多于十二个槽(例如,八个槽),并且可以以其它配置布置并且可以具有不同的形状。例如,第三槽162可以限定大致直的路径,或者可以具有从通道115的中心轴线径向向外的凹入部分。尽管在图4中部分被遮盖,但是第四槽172可以具有与第三槽162大致相似的特征。在一些实施方案中,槽162、172关于垂直于通道115的中心轴线107延伸的平面反射对称。在其它实施方案中,槽162、172可以各自包括不同数量的槽,和/或彼此之间具有不同的配置、形状等。此外,如图4所示,槽162、172可以比板120、130中的槽122、132长。在一些实施方案中,槽162、172径向延伸与槽122、132相同或基本相似的距离。
第一至第四槽122、132、162、172限定了销142的运动路径。例如,第一和第二槽122和132的尺寸和形状可以调整以保持各个叶片140相对于彼此的位置,第三和第四槽162和172的尺寸和形状可以调整以径向向内或向外驱动叶片140。因此,销142沿着槽路径的移动导致叶片140相对于彼此滑动,并且径向向内或向外移动。例如,第一可移动构件160相对于第一板120移动以驱动销142沿着由第一可移动构件160的第三槽162限定的路径移动,并且受第一板120的第一槽122的路径限制。类似地,第二可移动构件170相对于第二板130移动以驱动销142沿着由第二可移动构件170的第四槽172限定的路径移动,并且受第二板130的第二槽132的路径限制。当销142处于初始或第一销位置(图2)时,叶片140被布置为使得通道115具有最大横截面尺寸(例如直径),并且销142位于第一槽122的径向外端123a(图2)和第三槽162的径向外端162a(图4)。当销142处于最终或第二销位置(图3)时,销142位于第一槽122的径向内端123b(图3)和第三槽162的径向内端162b(图4),并且通道115具有最小横截面尺寸。因此,销142可以在第一和第二销位置之间移动,以减小和扩大通道115的横截面尺寸。在其它实施方案中,当处于第一和/或第二销配置时,销142可以沿着第一槽122位于不同的位置(例如,位于中间位置)。当医疗器械位于通道115内时,径向向内驱动销142可以减小医疗器械的横截面尺寸(例如直径)。在一些实施方案中,例如包括十二个叶片140的实施方案,叶片140被配置为将人工心脏瓣膜装置的外径从大约1.67英寸(42.42mm)减小到0.4英寸(10.16mm)或更小。例如,叶片140可以被配置为在第二销位置完全关闭通道115(即,通道115的横截面尺寸为零)。作为另一个实施例,在包括八个叶片140的实施方案中,叶片140可以布置为使得通道115具有大约1.3英寸(33.02mm)的最大外径,并且可以将通道115的直径减小到0.4英寸(10.16mm)或更小。通道115的最大和最小横截面尺寸可以取决于叶片140的数量、叶片140的尺寸和形状、销142在叶片140上的位置和/或由槽122、132、162、172限定的叶片140的行进路径。
如图4所示,第二板130包括多个第一连接特征133和多个第二连接特征135。第一连接特征133可以是孔、凸缘表面和/或其它连接机构,其被配置为将医疗器械保持器200(图1)可释放地连接到框架110的第二板120。第二连接特征135被配置为提供用于形成框架110的附接机构(例如,将第一板120连接到第二板130)。如图所示,第二连接特征135可以是钩或紧固件,其形状与第一板120上的相应孔125匹配。在一些实施方案中,第二连接特征135允许卷曲装置100的框架110被拆开,以允许例如清洁框架内的单个部件(例如,叶片140和可移动构件160、170)。在一些实施方案中,第一和第二板120和130可以通过结合、焊接和/或其它连接方法彼此固定连接。
如图4中进一步所示,卷曲装置100还可以包括驱动装置150,该驱动装置150可操作地连接到第一和第二可移动构件160和170,并且被配置为相对于第一和第二板120和130移动第一和第二可移动构件160、170。在一些实施方案中,如图4所示,驱动装置150包括耦接到螺纹轴152的驱动部件105和连接器154,连接器154具有延伸穿过其中的螺纹轴156。连接器154耦合到第一和第二可移动构件160、170的部分。转动驱动部件105使螺纹轴152绕螺纹轴152的纵向轴线转动,这又沿着螺纹轴152的长度移动连接器154。连接器154的移动使第一和第二可移动构件160、170移动,从而沿着由板120、130和可移动构件160、170的槽122、132、162、172限定的路径向内或向外驱动销142。例如,用户可以在第一方向上转动驱动部件105,以使连接器104向下移动(即,朝向页面底部),从而围绕通道115的中心轴线107顺时针旋转第一和第二可移动构件160、170。第一和第二可移动构件160、170的顺时针旋转可以沿着第一和第三槽122、162以及第二和第四槽132、172的组合路径向内驱动销142,以减小通道115的横截面尺寸。沿相反方向转动驱动部件105可以沿逆时针方向转动可移动构件160、170,以沿着第一和第三槽122、162以及第二和第四槽132、172的组合路径向外驱动销142,从而增加通道115的横截面尺寸。在一些实施方案中,驱动装置150可以被配置为沿相反方向旋转叶片140,以实现装置的压紧。图4所示的驱动装置150提供了放置在卷曲装置100的通道115内的医疗设备的连续(例如,而不是逐步)压紧,并且与其它类型的驱动器相比,可以具有相对较小的占地面积。
在一些实施方案中,驱动装置150可以包括不同的机构来驱动可移动构件160、170的运动,和/或驱动装置150可以以不同的方式耦合到可移动构件160、170。例如,在一些实施方案中,驱动装置150可以包括耦接到可移动构件160、170的杠杆。在其它实施方案中,可移动构件160、170可以被配置为相对于板120、130滑动(即,而不是旋转)。在这样的实施方案中,驱动装置150可以包括用于滑动可移动构件160、170的手柄或其它抓握机构。在其它实施方案中,驱动装置150可以包括被配置为移动可移动构件160、170的电动机。
图5是卷曲装置100(图1-4)的一个叶片140的等距视图。每个叶片140可以包括第一端部141a、第二端部141b、第一侧面143a和第二侧面143b。每个叶片140的销142可以包括从叶片140的第一侧面143a突出的第一销部142a(例如,朝向图1-4的卷曲装置100的入口侧101),以及从叶片140的第二侧面143b突出的第二销部142b(例如,图1-4中的朝向卷曲装置100的现有侧面103)。第一销部142a和第二销部142b(统称为“销部142a、142b”)可以是延伸穿过叶片140和/或与叶片140一体成型的单个部件(例如单个轴),或者销部142a、142b可以是从叶片140的任一侧突出的单独的销部件。在一些实施方案中,一些或所有叶片140可以仅包括第一销部142a或仅包括第二销部142b。如图5所示,销部142a、142b从叶片140的第二端部141b突出。当刀片140位于卷曲装置100内时,第二端部141b与通道115的中心轴线107间隔开并且在径向上远离第一端部141a。因此,销部142a、142b从叶片140的径向外部突出。与销的位于叶片的中心或更径向向内位置的叶片相比,销142的这种径向向外定位需要较少的驱动(即,销142不需要被驱动那么远)来产生叶片140的等量向内移动。结果,卷曲装置100的整体尺寸减小,同时仍然保持足够大的卷曲范围(例如,通道115的最小和最大横截面尺寸之间的范围),以适应处于扩张状态的医疗设备的尺寸和输送系统(例如,输送胶囊)的尺寸。
如图5进一步所示,叶片140包括内表面146a和外表面146b。一般来说,内表面146a和外表面146b被配置为使得相邻的叶片140能够相对于彼此滑动,并且限定卷曲装置100的通道115的形状。更具体地说,内表面146a通常可以沿着在叶片140的第一和第二侧面143a和143b之间延伸的轴线倾斜(例如,沿着图2-4所示的通道115的中心轴线107)。外表面146b可以具有大致成形为与相邻叶片140的内表面146a的形状匹配的部分,并且被配置为当销部142a、142b被驱动时(例如,沿着槽122、132和槽162、172径向向内或向外驱动)抵靠相邻叶片140的内表面146a滑动。
叶片140的内表面146a的一部分(例如,未被相邻叶片140的外表面146b覆盖的部分)共同限定卷曲装置100的通道115。当具有倾斜内表面146a的叶片140周向布置时,通道115可以具有大致漏斗状的形状(例如,如图8所示)。也就是说,通道115可以具有比叶片140的第一侧面143a更靠近叶片140的第二侧面143b(例如,在卷曲装置100的入口侧101靠近第二板130)的横截面尺寸(例如,在卷曲装置的出口侧103靠近第一板120)。在其它实施方案中,叶片140的内表面146a和外表面146b可以具有其它形状或布置。例如,每个叶片的内表面146a可以具有楔形形状,使得通道115沿着通道115的中心轴线具有恒定的横截面尺寸。在其它实施方案中,叶片140通常可以具有任何其它形状或构造,以便形成沿着通道115的中心轴线107具有变化的横截面尺寸的通道115。在一些实施方案中,叶片140的内表面和/或外表面146a、146b可以包括一个或多个凹槽、槽、孔等。这些特征可以减轻叶片140的重量,从而增加卷曲装置100的便携性,而不影响卷曲装置100的功能或强度。
在本技术的一些实施方案中,卷曲装置100可以省略上面参照图2-5描述的一个或多个部件。例如,卷曲装置100可以仅包括可移动构件160、170中的一个,并且每个叶片140可以仅包括销部142a或142b中的一个,以向内驱动叶片140来减小医疗设备的尺寸。然而,卷曲装置100的第一和第二侧面101和103处的两个可移动构件160、170和两个板120、130的余度(redundancy)有效地支撑了叶片140的第一和第二侧面143a、143b处的每个叶片140。包括两个可移动构件160、170也可以减少驱动叶片140所需的力量,并且可以有助于驱动力在叶片140上在第一和第二侧面143a、143b之间至少基本上相等的分布。在一些实施方案中,卷曲装置100可以包括少于十二个叶片(例如,四个叶片、五个叶片、六个叶片、八个叶片等)或多于十二个叶片(例如十六个叶片、二十个叶片等),并且可移动构件160、170和板120、130的槽122、132、162、172的数量可以被修改以对应于叶片140的数量。
上面参照图2-5描述的每个部件可以由相同或不同的材料制成,例如金属、聚合物、塑料、复合材料、它们的组合和/或其它材料。卷曲装置100的部件可以使用合适的工艺制造,例如三维打印、注射成型和/或用于在卷曲过程中支撑和压紧医疗设备的其它工艺。在一些实施方案中,每个部件由合适的塑料或聚合物制成,使得该系统是完全一次性的,并且能够以相对低的成本制造。在一些实施方案中,在此示出为单独部件的一些部件可以整体一起成型或者以其它方式组合。
在使用中,卷曲装置100可以提供紧凑但有效的机构,用于减小人工心脏瓣膜装置或其它医疗设备的尺寸。板120、130的槽122、132和可移动构件160、170的槽162、172限定了销142的路径,销142相对于彼此径向向内滑动叶片140以减小通道115的直径。该径向向内的力沿着在通道115内接触医疗器械的叶片140的表面是连续的,因此提供了医疗器械的连续压紧。因此,连续压紧允许用户在任何时候暂停或终止卷曲过程(即,不仅仅是在通道115的最大和最小直径处)。此外,由叶片形状提供的通道115的漏斗状形状允许在叶片向内移动期间医疗设备的部分比其它部分被压紧得更多。例如,医疗设备的较大部分可以位于通道115的较大部分中(例如,朝向卷曲装置100的入口侧101),并且不像医疗设备的位于通道115的较小部分中的部分(例如,朝向卷曲装置100的出口侧103)那样经受太多的压紧。这可以抑制压紧卷曲力将医疗设备横向移向卷曲装置100的入口侧101,并有助于在卷曲期间将医疗设备保持在通道115内。此外,销142在叶片140外部的位置减小了叶片140向内移动以实现所需卷曲范围所需的销行进路径的长度。例如,销142可以行进0.26英寸(6.604mm)的距离,以将通道直径从大约1.3英寸减小到0.4英寸或更小。因此,销142、叶片140、可移动构件160、170和板120、130的布置,连同驱动装置150,允许卷曲装置100具有紧凑的尺寸,临床医生可以容易地将卷曲装置100移入和移出无菌区域,同时仍然提供适于减小人工心脏瓣膜尺寸的大的卷曲范围,以允许装置的经皮输送。
图6是示出根据本技术的实施方案配置并耦合到示例性医疗设备500的医疗设备保持器200(“保持器200”)的等距视图。在如图6所示的一些实施方案中,医疗设备500是用于人工心脏瓣膜装置的瓣膜保持器。保持器200包括基部202,基部202具有第一侧面203a、第二侧面203b和在其间延伸的开口205。基座202可以包括在第二侧面203b上的多个连接器201,并且被配置为将保持器200可移除地耦接到卷曲装置100(例如,耦接到图2-4的第二板130的连接特征113)。如图6所示,基座202可以具有大致环形的形状,包括径向的外表面209a和径向的内表面209b,两者都在第一侧面203a和第二侧面203b之间延伸。外表面209a可以包括多个凹槽207和/或脊,以使得保持器200易于抓握和操作,即使在卷曲过程中被浸没。保持器200还包括多个第一指状物206和多个第二指状物208(统称为“指状物206、208”),它们从基部202突出并围绕延伸穿过基部202的开口205的中心轴线周向布置。指状物206、208被配置为接合医疗设备500的至少一部分,以在卷曲过程的至少初始部分期间将医疗设备500保持在卷曲设备100的通道115内(图2-4)。
如图6所示,第一指状物206可以围绕开口205的中心轴线间隔开,以在围绕医疗设备500的圆周的不止一个点处接合医疗设备500。第一指状物206包括从基部202的内表面209b朝向开口205的中心轴线径向向内延伸的第一部分206a、从基部202的第一部分206a延伸并远离第二侧面203b的第二部分206b、从第二部分206b延伸并朝向开口205的中心轴线径向向内的第三部分206c、以及被配置为接合医疗设备500的第四部分206d。第四部分206d可以包括被成形为接合医疗设备500的一部分的索引特征(index feature)206e。例如,如图6所示,医疗设备500可以是包括框架580的支架装置,框架580包括多个框架单元582。每个框架单元582可以具有六边形形状,并且包括一对第一支柱583、一对第二支柱584和一对第三支柱585。每个第一支柱583可以从第二支柱584的一端延伸,并且成对的第一支柱583可以连接在一起以形成V形支柱586。框架580端部的至少一些V形支柱586可以限定顶点587。如图所示,索引特征206e可以具有大致呈V形的形状,以接合(例如,配合)医疗设备500的单个V形支柱586。在其它实施方案中,医疗设备500和/或第一指状物206可以具有其它合适的形状,使得第一指状物206能够接合医疗设备500的一部分。例如,医疗设备500可以是具有框架单元582的支架装置,框架单元582具有矩形、正弦形、三角形、多边形或其它形状,并且索引特征206e可以具有与框架单元582的一部分匹配或装配在框架单元582的一部分内的相应形状和布置。在一些实施方案中,第一指状物206被配置为与人工二尖瓣装置的瓣膜支撑件的心房端和/或人工二尖瓣装置的其它心房的部分接合。在一些实施方案中,第一指状物206被配置为与瓣膜保持器的心室侧和/或人工二尖瓣装置的其它心室的部分接合。
在一些实施方案中,第一指状物206是柔性的,使得它们响应于施加到第一指状物206的外力而径向向内或向外弯曲。例如,当保持器200没有附接到医疗设备500时,第一指状物206的第四部分206d可以被定位为远离开口205的中心轴线的距离,该距离略大于医疗设备500的横截面尺寸。为了连接医疗设备500,第一指状物206可以径向向内弯曲,直到第一指状物206的第四部分206d在医疗设备500内,然后被释放。因此,第一指状物206的索引特征206e可以压靠(例如,第一指状物206稍微径向向外偏压)医疗设备500的径向内侧,以保持或抓握医疗设备500。当没有其它力施加到第一指状物206时,索引特征206e可以防止医疗设备500从保持器200滑落。当保持器200附接到卷曲装置100时(图1-4),随着通道115尺寸减小,叶片140可以向下压在第一指状物206上,从而导致第一指状物206向内弯曲,并且从保持器200释放医疗设备500,以便随后装载到输送系统600中(图1)。
第二指状物208可以各自包括从基部202的内表面209b朝向开口205的中心轴线径向向内延伸的第一部分208a、从基部202的第一部分208a延伸并远离第二侧面203b的第二部分208b、以及从第二部分208b朝向开口205的中心轴线径向向内延伸的第三部分206c。值得注意的是,每个第二指状物208的第一部分208a比每个第一指状物206的第一部分206a长。因此,第一指状物206的第二部分206b比第二指状物208的第二部分208b径向更远离开口205的中心轴线。如图所示,第二指状物208的第三部分208c可以被成形和定位为接收医疗设备500的顶点587。因此,第二指状物208可以为将医疗设备500保持就位提供额外的支撑。在一些实施方案中,保持器200可以包括具有其它形状、布置、数量等的指状物206、208。适于将医疗设备500保持在适当的位置。例如,保持器200可以包括图6所示的多于或少于十二个指状物206、208(例如,多于或少于三个第一指状物206和多于或少于九个第二指状物208)。在一些实施方案中,保持器200仅包括第一指状物206或仅包括第二指状物208。
图7和8分别是等距视图和横截面侧视图,示出了连接到图2-4所示卷曲装置100的图6的保持器200。为了便于说明,医疗设备500没有在图7和8中示出。首先参考图7,保持器200可以经由框架110的第二板130可移除地耦合到卷曲装置100的入口侧101。更具体地,保持器200的连接器201(如图6所示)可以连接到设置在框架110上的第一连接特征133。在一些实施方案中,连接器201是钩字、紧固件、夹子、锁定特征等中的至少一个。其接合(例如,配合)第一连接特征133,以可移除地将保持器200固定到卷曲装置100。在一些实施方案中,连接器201被插入连接特征113中,并且保持器200被旋转以将保持器200固定就位。一旦被固定,保持器200的开口205的中心轴线通常可以与卷曲装置100的通道115的中心轴线107对齐。通过对齐卷曲装置100和保持器200的中心轴线,在卷曲医疗设备500之前,医疗设备500可以相对于通道115内的叶片140均匀地间隔开,以便于医疗设备500的大致对称的径向压紧。
如图8所示,保持器200的指状物206、208可以至少部分地突出到卷曲装置100的通道115中。因此,保持器200的指状物206、208可以将医疗设备500(图6)保持在完全在通道115内的位置。图8还示出了一个实施方案,其中通道115具有大致漏斗状的形状,其中通道115的横截面尺寸(例如直径)沿着从卷曲装置100的入口侧101向卷曲装置100的出口侧103移动的中心轴线107减小。
参考图6-8,为了卷曲医疗设备500,如上所述操纵驱动部件105以减小通道115的直径。随着通道115的直径减小,叶片140的部分可以接触通道115内的第一指状物206的部分和/或第二指状物208的部分。具体地,叶片140首先接触第一指状物206的第二部分206b,因为它们比第二指状物208的第二部分208b(图6)径向更远离通道115的中心轴线。随着通道115的直径进一步减小,叶片140对第二指状物208施加向内的力,该力径向向内弯曲指状物208,并导致第一指状物206的第四部分206d从医疗设备500脱离。叶片140直到接触第二指状物208之后才接触第一指状物206,因为第二指状物208的第二部分208b比第一指状物206的第二部分206b径向更靠近通道115的中心轴线107。因此,在第一指状物206从医疗设备500脱离之后,第二指状物208的第三部分208c仍然可以接合和支撑医疗设备500的一部分(例如顶点587)。在一些实施方案中,当医疗设备500卷曲时,第二指状物208可以阻止医疗设备500横向移动(例如,在相对的板120、130之间平移)。例如,由于通道115的漏斗状形状导致的医疗设备500的不均匀压紧,第二指状物208可以抵消医疗设备500朝向卷曲装置100的入口侧101横向移动的趋势。
在一些实施方案中,通道115的直径可以减小到足够小的直径,以使保持器200从医疗设备500脱离(例如,脱离第一指状物206),但是保持较大的直径,使得位于医疗设备500内的指状物206、208不会干扰医疗设备500的卷曲。例如,保持器200和卷曲装置100可以被配置为使得保持器200:(i)当卷曲装置100的通道115具有最大直径(例如,图2所示的第一位置)时保持(例如,接合和抓握)医疗设备500,并且(ii)当卷曲装置100的通道115具有最小直径(例如,图3所示的第二位置)时从医疗设备500脱离。在一些实施方案中,在保持器200从医疗设备500脱离之后,保持器200可以从卷曲设备100移除。在这样的实施方案中,通道115的直径之后可以进一步减小,以进一步卷曲医疗设备500。
用于接收卷曲装置的托盘的选定实施方案
图9是根据本技术的实施方案配置的图1的卷曲和装载系统10的托盘300的俯视图。托盘300可以使用热成型工艺和/或其它合适的托盘成型工艺来成型。如图所示,托盘300的内壁限定了用于容纳液体(例如,冷冻盐水)的储存器310。储存器310可以包括第一部分312、第二部分314和第三部分316。第一部分312的尺寸和形状可被设计成接收卷曲装置100(图1-4),在使用之前(例如,在储存和/或运输期间),入口侧101或出口侧103面朝下抵靠托盘300的底面。储存器310的第二部分314由托盘300的凸缘305限定,并且包括凹部315,凹部315被配置为在卷曲过程中将卷曲装置100(图1-4)保持在稳定的直立位置。在一些实施方案中,托盘300包括用于将液体引入储存器310的槽。槽可以被配置为允许液体以非湍流方式进入储存器310,这预期会抑制气泡在托盘300或卷曲装置100的部分中形成。例如,在一些实施方案中,槽提供进入储存器310的第一部分312的液体流动路径。
储存器310的第三部分316可以位于卷曲装置100的出口侧103(例如,如图1所示),并且可以提供卷曲的医疗设备可以装载到输送系统(例如,图1的输送系统)中的区域。在一些实施方案中,储存器310的第三部分316还可以提供一个区域,以在装置装载期间显现卷曲装置100的通道115和/或邻近卷曲装置100定位的输送系统的部分(图1)。例如,托盘300可以包括倾斜侧壁(分别标识为第一倾斜侧壁317a和第二倾斜侧壁317b;统称为“倾斜侧壁317”),其上可以放置一个或多个镜子,以提供卷曲装置100(图1-4)和/或输送系统的替代视图。在一些实施方案中,托盘300在第三部分316中具有大致平坦的下表面,反射镜设置在下表面上,以在设备装载期间可见。储存器310的第三部分316也可以形成为接收支架400(图1),使得支架400可以在使用之前(例如,在储存和/或运输期间)位于第三部分316中。因此,在一些实施方案中,系统10(图1)的每个组件可以牢固地位于托盘300的专用部分内,用于运输和存储。因此,系统10(图1)可以以流线型和无菌的方式提供给医生。
如图9进一步所示,托盘300的壁还包括用于接收输送系统(例如,图1的输送系统600)的一部分的孔320,以及一个或多个凹槽(分别标识为第一凹槽319a和第二凹槽319b;统称为“凹槽319”),位于孔320的任一侧。凹槽319可以被配置为接收凸楞(dam)构件(未示出),用于密封储存器310并防止液体通过孔320逸出。在一些实施方案中,合适的输送系统的一部分可以刺穿位于凹槽319内的凸楞构件,以便将输送系统的该部分定位于卷曲装置100附近(图1)。在一些实施方案中,托盘300可以包括阀和/或密封装置,该阀和/或密封装置位于托盘300的侧壁上(例如,在孔320或其它孔中),并且与储存器310流体连通。阀和/或密封装置可以在输送系统(例如,图1的输送系统600)移动通过之前、期间和/或之后流体密封储存器310中的液体。例如,阀(例如,交叉狭缝阀、单向止回阀等)可以容纳在垫圈(例如,模制硅树脂垫圈)内,垫圈位于托盘300侧壁的孔中,以至少部分地防止当输送系统移入和移出阀构件时液体从储存器310泄漏。在其它实施方案中,托盘300可以包括阀和/或密封装置的其它配置,以密封储存器310内的液体,同时仍然允许从托盘300的侧壁进入储存器310,用于装置装载或调节。
实施例
本技术的几个方面由以下实施例阐述。
1.一种卷曲装置,其包括:
固定板,其具有多个第一槽;
可移动构件,其具有多个第二槽,其中各个第二槽与相应的各个第一槽的一部分对齐;
多个可移动叶片,其周向布置以形成具有延伸穿过其中的中心轴线的通道,其中——
每个叶片具有第一端部和第二端部,并且其中第二端部比第一端部更径向远离中心轴线,
每个叶片包括从叶片的第二端部伸出的销,并且
每个销延伸穿过第一槽中的一个和相应的第二槽中的一个;和
驱动装置,其可操作地连接到可移动构件,并且被配置为相对于固定板移动可移动构件,其中可移动构件的移动沿着由第一槽和第二槽限定的路径驱动多个销,使得多个叶片径向向内移动以减小通道的直径,并且其中叶片的径向向内移动被配置为减小位于通道内的医疗设备的直径,以适应使用微创工序植入医疗设备的输送胶囊的尺寸。
2.如实施例1所述的卷曲装置,其中叶片包括第一侧面和背离第一侧面的第二侧面,固定板是面向叶片的第一侧面的第一固定板,可移动构件是面向叶片的第一侧面的第一可移动构件,并且每个销是每个叶片的第一侧面上的第一销,并且其中卷曲装置还包括:
第二固定板,其面向叶片的第二侧面,第二固定板具有多个第三槽;
第二可移动构件,其面向叶片的第二侧面,该第二可移动构件具有多个第四槽,
其中——
每个叶片包括从叶片第二侧面上的第二端部伸出的第二销,
每个第二销延伸穿过第三槽中的一个和相应的第四槽中的一个,并且
驱动装置可操作地连接到第一可移动构件和第二可移动构件,并被配置为相对于第一固定板和第二固定板移动第一可移动构件和第二
可移动构件,从而驱动多个叶片以改变通道的直径。
3.如实施例1或2所述的卷曲装置,其中第二槽限定弧形路径,弧形路线具有第一端和比第一端更靠近通道的第二端。
4.如实施例1-3中任一项所述的卷曲装置,其中通道的直径沿中心轴线变化。
5.如实施例1-4中任一项所述的卷曲装置,其中叶片具有限定通道的内表面,并且其中内表面的形状使得通道具有大致漏斗状的形状。
6.如实施例1-5中任一项所述的卷曲装置,其中多个叶片包括十二个叶片。
7.如实施例1-6中任一项所述的卷曲装置,其中——
可移动构件具有第一位置,在第一位置通道具有最大直径,
可移动构件具有第二位置,在第二位置通道具有最小直径,并且
销在第一位置比在第二位置离中心轴线径向更远。
8.如实施例1-7中任一项所述的卷曲装置,其进一步包括:
框架;和
保持器,其可移除地连接到框架,并且被配置为当叶片减小医疗设备的直径时将医疗设备保持在通道内。
9.如实施例8所述的卷曲装置,其中——
可移动构件具有第一位置和第二位置,
通道在第二位置的直径小于在第一位置的直径,并且
保持器包括多个指状物,多个指状物被配置为在第一位置接合医疗设备的一部分,并被配置为在第二位置从医疗设备的一部分脱离。
10.如实施例1-9中任一项所述的卷曲装置,其中,第一槽限定了远离中心轴线径向延伸的直线路径。
11.如实施例1-10中任一项所述的卷曲装置,其中第二槽的长度比第一槽的长度长。
12.如实施例1-11中任一项所述的卷曲装置,其中第一槽和第二槽围绕中心轴线等角度间隔开。
13.如实施例1-12中任一项所述的卷曲装置,还包括连接到可移动构件并具有延伸穿过其中的螺纹孔的连接器,其中——
可移动构件是可旋转构件,
驱动装置是螺纹轴,并且延伸穿过连接器的螺纹孔,并且
驱动可旋转构件包括围绕所述轴的纵向轴线旋转螺纹轴,使得连接器沿着所述轴移动。
14.如实施例1-13中任一项所述的卷曲装置,其中,通道被配置为接收用于植入天然二尖瓣的人工心脏瓣膜装置,并且其中,叶片被配置为将人工心脏瓣膜装置的外径从1.300英寸减小到0.4英寸或更小。
15.一种用于减小支架装置尺寸的系统,该系统包括:
一种卷曲装置,其包括——
框架,其具有固定板,固定板具有多个第一槽,
可移动构件,其具有多个第二槽,其中可移动构件可相对于固定板移动,
多个可移动叶片,其周向布置以限定具有延伸穿过其中的中心轴线的通道,其中——
通道被配置为接收处于未扩张状态的人工心脏瓣膜装置,
可移动构件位于叶片和固定板之间,
每个叶片具有第一端部和第二端部,第二端部比第一端部更径向远离中心轴线,
每个叶片包括从第二端部突出并延伸穿过第一槽中的一个和相应的第二槽中的一个的销,以及
驱动装置,其被配置为移动可移动构件以在通道具有第一横截面尺寸的第一位置和通道具有小于第一横截面尺寸的第二横截面尺寸的第二位置之间驱动多个叶片,其中将叶片从第一位置移动到第二位置减小了支架装置的外部尺寸,并且其中第一槽被配置为当叶片在第一位置和第二位置之间移动时保持叶片之间的相对位置;和
保持器,其可移除地连接到框架,并且被配置为当叶片处于第一位置时将支架装置保持在通道内。
16.如实施例15所述的系统,其中叶片被配置为当叶片从第一位置移动到第二位置时连续压紧所述人工心脏瓣膜装置。
17.如实施例15或16所述的系统,其中通道具有漏斗形状。
18.如实施例15-17中任一项所述的系统,还包括限定储存器的托盘,储存器被配置为在其中接收卷曲装置。
19.如实施例18所述的系统,其中,储存器被配置为在其中容纳冷却液体,并且其中,当卷曲装置位于储存器内时,液体填充所述通道。
20.如实施例18所述的系统,其中托盘包括穿过托盘延伸至储存器的孔,其中卷曲装置的通道可通过该孔进入,以允许所述人工心脏瓣膜装置位于通道内。
21.如实施例15-20中任一项所述的系统,其中——
保持器包括多个指状物,多个指状物被配置为在第一位置接合人工心脏瓣膜装置的附接特征;并且
叶片的尺寸和形状被设计成当叶片从第一位置移动到第二位置时压靠在指状物上,以将连接部件从保持器上脱离。
22.如实施例15-21中任一项所述的系统,其中,在第一位置销比在第二位置径向更远离通道的中心轴线。
23.一种用于减小装载到输送胶囊中的医疗设备的尺寸的方法,包括:
将医疗设备位于卷曲设备的通道内,其中——
通道由围绕通道的中心轴线周向布置的多个可移动叶片限定,
每个叶片包括从叶片的端部伸出的销,销与通道径向隔开,并且
每个销穿过固定板上的第一槽和位于固定板和叶片之间的可移动构件上的第二槽伸出;并且
将叶片从第一位置径向向内驱动到第二位置,以减小通道的横截面尺寸,从而减小医疗设备的外径,其中驱动叶片包括相对于固定板移动可移动构件,以沿着由相应的第二槽限定的各个弧形路径移动销。
24.如实施例23所述的方法,其中径向向内驱动叶片包括将叶片从第一位置驱动到第二位置,其中第一位置的通道具有至少1.300英寸的最小横截面尺寸,第二位置的通道具有至多0.4英寸的最小横截面尺寸。
25.如实施例23或24所述的方法,其中径向向内驱动叶片包括将每个销从弧形路径的第一端向弧形路径的第二端移动,其中第二端比第一端更靠近通道的中心轴线。
26.如实施例23-25中任一项所述的方法,其中径向向内驱动叶片包括连续压紧所述医疗设备。
27.如实施例23-26中任一项所述的方法,其中所述医疗设备是人工心脏瓣膜设备,并且其中该方法进一步包括:
将人工心脏瓣膜装置的多个接合特征可移除地连接到保持器的相应多个指状物,其中保持器在叶片处于第一位置时保持所述人工心脏瓣膜装置;并且
其中径向向内驱动叶片将叶片压靠在指状物的外表面上,以使接合特征与保持器脱离接合。
28.如实施例23-27中任一项所述的方法,其中叶片具有限定通道的内表面,其中内表面成形为使得通道具有大致漏斗状的形状,并且还包括:
在将叶片驱动到第二位置之后,将医疗设备通过通道移向输送胶囊,以进一步减小医疗设备的外径。
29.如实施例23-28中任一项所述的方法,还包括将卷曲装置浸没在液体中,使得医疗设备在位于通道内时浸没在液体中。
结论
上述对技术实施方案的详细描述并不旨在穷举或将技术限制为上述公开的精确形式。尽管以上出于说明目的描述了本技术的具体实施方案和实施例,但是相关领域的技术人员将会认识到,在本技术的范围内,各种等同的修改是可能的。例如,尽管步骤以给定的顺序呈现,但是替代实施方案可以以不同的顺序执行步骤。在此描述的多种实施方案也可以被组合以提供其它实施方案。
从前述内容中,可以理解,出于说明的目的,本文已经描述了本技术的特定实施方案,但是未详细示出或描述公知的结构和功能,以避免不必要地混淆对本技术实施方案的描述。在上下文允许的情况下,单数或复数术语也可以分别包括复数或单数术语。
此外,除非明确地将“或”一词限制为与两个或多个项目的列表中的其它项目相排斥的单个项目,否则在该列表中使用“或”应被解释为包括(a)列表中的任何单个项目,(b)列表中的所有项目,或(c)列表中项目的任何组合。此外,术语“包括”在全文中用于表示至少包括所述特征,从而不排除任何更多数量的相同特征和/或附加类型的其它特征。还应当理解,为了说明的目的,这里已经描述了特定的实施方案,但是在不偏离本技术的情况下可以进行多种修改。此外,虽然已经在这些实施方案的上下文中描述了与本技术的某些实施方案相关联的优点,但是其它实施方案也可以展示这些优点,并且并非所有实施方案都必须展示这些优点才能落入本技术的范围内。因此,本公开和相关技术可以包括本文未明确示出或描述的其它实施方案。
Claims (29)
1.一种卷曲装置,其包括:
固定板,其具有多个第一槽;
可移动构件,其具有多个第二槽,其中各个第二槽与相应的各个第一槽的一部分对齐;
多个可移动叶片,其周向布置以形成具有延伸穿过其中的中心轴线的通道,其中——
每个叶片具有第一端部和第二端部,并且其中所述第二端部比所述第一端部更径向远离中心轴线,
每个叶片包括从所述叶片的第二端部伸出的销,并且
每个销延伸穿过所述第一槽中的一个和相应的所述第二槽中的一个;和
驱动装置,其可操作地连接到所述可移动构件,并且被配置为相对于所述固定板移动所述可移动构件,其中所述可移动构件的移动沿着由所述第一槽和第二槽限定的路径驱动所述多个销,使得所述多个叶片径向向内移动以减小所述通道的直径,并且其中所述叶片的径向向内移动被配置为减小位于所述通道内的医疗设备的直径,以适应使用微创工序植入所述医疗设备的输送胶囊的尺寸。
2.如权利要求1所述的卷曲装置,其中所述叶片包括第一侧面和背离所述第一侧面的第二侧面,所述固定板是面向所述叶片的第一侧面的第一固定板,所述可移动构件是面向所述叶片的第一侧面的第一可移动构件,并且每个销是每个叶片的第一侧面上的第一销,并且其中所述卷曲装置还包括:
第二固定板,其面向所述叶片的第二侧面,所述第二固定板具有多个第三槽;
第二可移动构件,其面向所述叶片的第二侧面,该所述第二可移动构件具有多个第四槽,
其中——
每个叶片包括从所述叶片第二侧面上的所述第二端部伸出的第二销,
每个第二销延伸穿过所述第三槽中的一个和相应的所述第四槽中的一个,并且
驱动装置可操作地连接到所述第一可移动构件和第二可移动构件,并被配置为相对于所述第一固定板和第二固定板移动所述第一可移动构件和第二可移动构件,从而驱动所述多个叶片以改变所述通道的直径。
3.如权利要求1所述的卷曲装置,其中所述第二槽限定弧形路径,弧形路径具有第一端和比第一端更靠近通道的第二端。
4.如权利要求1所述的卷曲装置,其中所述通道的直径沿所述中心轴线变化。
5.如权利要求1所述的卷曲装置,其中所述叶片具有限定所述通道的内表面,并且其中所述内表面的形状使得所述通道具有大致漏斗状的形状。
6.如权利要求1所述的卷曲装置,其中所述多个叶片包括十二个叶片。
7.如权利要求1所述的卷曲装置,其中——
所述可移动构件具有第一位置,在所述第一位置所述通道具有最大直径,
所述可移动构件具有第二位置,在所述第二位置所述通道具有最小直径,并且
所述销在所述第一位置比在所述第二位置离所述中心轴线径向更远。
8.如权利要求1所述的卷曲装置,其进一步包括:
框架;和
保持器,其可移除地连接到所述框架,并且被配置为当所述叶片减小医疗设备的直径时将所述医疗设备保持在所述通道内。
9.如权利要求8所述的卷曲装置,其中——
所述可移动构件具有第一位置和第二位置,
所述通道在所述第二位置的直径小于在所述第一位置的直径,并且
所述保持器包括多个指状物,所述多个指状物被配置为在所述第一位置接合医疗设备的一部分,并被配置为在所述第二位置从医疗设备的一部分脱离。
10.如权利要求1所述的卷曲装置,其中,所述第一槽限定了远离所述中心轴线径向延伸的直线路径。
11.如权利要求1所述的卷曲装置,其中所述第二槽的长度比所述第一槽的长度长。
12.如权利要求1所述的卷曲装置,其中所述第一槽和所述第二槽围绕所述中心轴线成角度地等距离间隔开。
13.如权利要求1所述的卷曲装置,还包括连接到所述可移动构件并具有延伸穿过其中的螺纹孔的连接器,其中——
所述可移动构件是可旋转构件,
所述驱动装置是螺纹轴,并且延伸穿过所述连接器的螺纹孔,并且
驱动所述可旋转构件包括围绕螺纹轴的纵向轴线旋转所述螺纹轴,使得所述连接器沿着螺纹轴移动。
14.如权利要求1所述的卷曲装置,其中,所述通道被配置为接收用于植入天然二尖瓣的人工心脏瓣膜装置,并且其中,所述叶片被配置为将所述人工心脏瓣膜装置的外径从1.300英寸减小到0.4英寸或更小。
15.一种用于减小支架装置尺寸的系统,该系统包括:
一种卷曲装置,包括——
框架,其具有固定板,所述固定板具有多个第一槽,
可移动构件,其具有多个第二槽,其中所述可移动构件可相对于所述固定板移动,
多个可移动叶片,其周向布置以限定具有延伸穿过其中的中心轴线的通道,其中——
所述通道被配置为接收处于未扩张状态的人工心脏瓣膜装置,
所述可移动构件位于所述叶片和所述固定板之间,
每个叶片具有第一端部和第二端部,所述第二端部比所述第一端部更径向远离所述中心轴线,
每个叶片包括从所述第二端部突出并延伸穿过所述第一槽中的一个和相应的所述第二槽中的一个的销,以及
驱动装置,其被配置为移动所述可移动构件以在所述通道具有第一横截面尺寸的第一位置和通道具有小于第一横截面尺寸的第二横截面尺寸的第二位置之间驱动多个叶片,其中将所述叶片从第一位置移动到第二位置减小了所述支架装置的外部尺寸,并且其中所述第一槽被配置为当所述叶片在所述第一位置和第二位置之间移动时保持叶片之间的相对位置;和
保持器,其可移除地连接到所述框架,并且被配置为当所述叶片处于所述第一位置时将所述支架装置保持在所述通道内。
16.如权利要求15所述的系统,其中所述叶片被配置为当所述叶片从所述第一位置移动到所述第二位置时连续压紧所述人工心脏瓣膜装置。
17.如权利要求15所述的系统,其中所述通道具有漏斗形状。
18.如权利要求15所述的系统,还包括限定所述储存器的托盘,所述储存器被配置为在其中接收所述卷曲装置。
19.如权利要求18所述的系统,其中,所述储存器被配置为在其中容纳冷却液体,并且其中,当所述卷曲装置位于所述储存器内时,所述液体填充所述通道。
20.如权利要求18所述的系统,其中所述托盘包括穿过所述托盘延伸至所述储存器的孔,其中所述卷曲装置的所述通道可通过所述孔进入,以允许所述人工心脏瓣膜装置位于所述通道内。
21.如权利要求15所述的系统,其中——
所述保持器包括多个指状物,所述多个指状物被配置为在所述第一位置接合人工心脏瓣膜装置的附接特征;并且
所述叶片的尺寸和形状被设计成当所述叶片从所述第一位置移动到所述第二位置时压靠在指状物上,以将所述连接部件从所述保持器上脱离。
22.如权利要求15所述的系统,其中,在所述第一位置所述销比在所述第二位置更径向远离所述通道的所述中心轴线。
23.一种用于减小装载到输送胶囊中的医疗设备的尺寸的方法,包括:
将所述医疗设备位于所述卷曲设备的通道内,其中——
所述通道由围绕所述通道的中心轴线周向布置的多个可移动叶片限定,
每个叶片包括从叶片的端部伸出的销,所述销与所述通道径向隔开,并且
每个销穿过固定板上的第一槽和位于所述固定板和所述叶片之间的可移动构件上的第二槽伸出;并且
将所述叶片从第一位置径向向内驱动到第二位置,以减小所述通道的横截面尺寸,从而减小所述医疗设备的外径,其中驱动所述叶片包括相对于固定板移动所述可移动构件,以沿着由相应的第二槽限定的各个弧形路径移动销。
24.如权利要求23所述的方法,其中径向向内驱动所述叶片包括将所述叶片从所述第一位置驱动到所述第二位置,其中所述第一位置的通道具有至少1.300英寸的最小横截面尺寸,所述第二位置的通道具有至多0.4英寸的最小横截面尺寸。
25.如权利要求23所述的方法,其中径向向内驱动所述叶片包括将每个销从弧形路径的第一端向弧形路径的第二端移动,其中弧形路径的第二端比第一端更靠近所述通道的所述中心轴线。
26.如权利要求23所述的方法,其中径向向内驱动所述叶片包括连续压紧所述医疗设备。
27.如权利要求23所述的方法,其中所述医疗设备是人工心脏瓣膜设备,并且其中所述方法进一步包括:
将所述人工心脏瓣膜装置的多个接合特征可移除地连接到保持器的相应多个指状物,其中所述保持器在所述叶片处于所述第一位置时保留所述人工心脏瓣膜装置;并且
其中径向向内驱动所述叶片将所述叶片压靠在所述指状物的外表面上,以使所述接合特征与所述保持器脱离接合。
28.如权利要求23所述的方法,其中所述叶片具有限定所述通道的内表面,其中所述内表面成形为使得所述通道具有大致漏斗状的形状,并且还包括:
在将所述叶片驱动到所述第二位置之后,将所述医疗设备通过所述通道移向所述输送胶囊,以进一步减小所述医疗设备的外径。
29.如权利要求23所述的方法,还包括将所述卷曲装置浸没在液体中,使得所述医疗设备在位于所述通道内时浸没在液体中。
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CN113509293A (zh) | 2021-10-19 |
EP3634322A1 (en) | 2020-04-15 |
US20220362042A1 (en) | 2022-11-17 |
CN110740712B (zh) | 2021-09-14 |
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US20180344490A1 (en) | 2018-12-06 |
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US11464659B2 (en) | 2022-10-11 |
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