CN116421249A - 具有改进的牵拉线的植入物分离系统 - Google Patents
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Abstract
本发明提供了一种用于将栓塞线圈植入物递送到治疗部位的分离系统。穿过分离系统的管腔的牵拉线可包括松弛区段,该牵拉线接合环线。松弛区段可以是一个或多个弯曲部、螺旋线圈或可拉伸材料。当分离系统正穿过微导管时,松弛区段通过阻止牵拉线的远侧端部的移动而有效地阻止植入式医疗装置的过早分离。
Description
技术领域
本发明整体涉及在人类受试者的身体血管中进行导航的血管内医疗装置系统,并且更具体地涉及用于将植入式医疗装置递送和部署到身体血管的目标位置的分离/递送系统以及使用分离/递送系统的方法。
背景技术
通过将治疗装置递送到动脉瘤以用栓塞材料填充动脉瘤的囊和/或阻塞动脉瘤的颈部以防止血流进入动脉瘤中,可以对动脉瘤进行血管内治疗。当填充动脉瘤囊时,栓塞材料可促进血液凝结,以在动脉瘤内产生血栓块。当治疗动脉瘤颈部而基本不填充动脉瘤囊时,可抑制进入动脉瘤颈部的血流,以引起动脉瘤中的静脉停滞并促进动脉瘤内的血栓块的自然形成。
在一些当前的治疗中,多个栓塞线圈用于填充动脉瘤囊或治疗动脉瘤颈部的入口。栓塞线圈治疗中的常见挑战是植入的线圈和部分植入的线圈的植入部分可缠结并且难以重新定位。在一些情况下,医师可无法回缩部分植入的线圈,并且可被迫将线圈定位在非理想位置。栓塞线圈在动脉瘤颈部处定位不当可产生阻碍血液在相邻血管中流动的不利影响,特别是在入口和/或囊过度填充的情况下。如果放置不当的线圈的一部分移位,则其可进入相邻血管并促进凝块形成,这可最终导致阻塞,该阻塞被栓系到动脉瘤并因此极其难以治疗。相反地,如果入口和/或囊未被充分填充,则血流可以持续进入动脉瘤中。
在一些当前的治疗中,栓塞线圈附接到管状递送装置并且经由递送导管递送到动脉瘤。在递送期间,栓塞线圈可接合到递送构件的植入物分离/部署系统(本文中等效地称为″分离系统″或″部署系统″)。当栓塞线圈就位时,展开系统可释放线圈,线圈可保持植入,并且递送构件可回缩。一些治疗利用机械分离/部署系统,该系统可由医师致动以通过牵拉一根或多根线材或在本文中统称为″牵拉线″的其他伸长构件来释放植入物。与使用具有机械分离系统的递送构件递送和部署栓塞线圈相关联的一些挑战包括由于牵拉线向近侧过早移动而导致线圈过早释放,从而在系统到达治疗部位之前释放线圈。由于系统通过曲折的脉管系统移动到治疗部位,这种情况会加剧。
因此,需要有利于面临类似挑战的栓塞线圈和其他植入物的植入的改进的方法、装置和系统。
发明内容
本发明的目的是提供满足上述需求的系统、装置和方法。在本文提出的一些示例中,可通过提供具有松弛区段的牵拉线来减少牵拉线的过早向近侧移动或平移,该松弛区段允许牵拉线的近侧部分独立于牵拉线的远侧端部移动,从而使得能够对向近侧移动具有一定公差以防止牵拉线通过环线的过早缩回。
用于将植入式医疗装置递送到身体血管的目标位置的分离系统可包括管状主体,该管状主体包括延伸穿过其的管腔和压缩远侧管。分离系统可包括环线,该环线包括附连到管状主体的第一端部并包括定位成靠近压缩远侧管的远侧端部的环开口。分离系统可包括延伸穿过管腔并穿过环开口的牵拉线。牵拉线可包括定位在管腔内的松弛区段,使得当分离系统正穿过微导管时,牵拉线的近侧端部能够独立于牵拉线的远侧端部向近侧和向远侧平移。
当牵拉线处于放松状态时,松弛区段可具有第一长度,并且当牵拉线处于张紧状态时,松弛区段可具有第二长度。当松弛区段超过第二长度时,牵拉线的远侧端部可向近侧平移。
当分离系统正穿过微导管时,松弛区段可通过阻止牵拉线的远侧端部的移动来阻止植入式医疗装置的过早分离。
松弛区段可以是在牵拉线中的定位在环线接触牵拉线的位置的近侧的多个弯曲部。
松弛区段可以是形成在牵拉线中的靠近环线接触拉线的位置的螺旋线圈。
松弛区段可以是可拉伸材料的区段,该可拉伸材料的区段沿着牵拉线的长度定位在环线接触牵拉线的位置的近侧。
牵拉线可由近侧刚性区段和远侧刚性区段限定,并且包括可拉伸材料的松弛区段可定位在近侧刚性区段与远侧刚性区段之间,其中近侧刚性区段和远侧刚性区段具有比可拉伸材料的区段低的弹性程度。
可拉伸材料的区段可以是聚合物缝合线。
分离系统可包括靠近植入式医疗装置的近侧端部附连到植入式医疗装置的键。键可包括穿过其中的远侧开口,其中抗拉伸纤维穿过该远侧开口。键可包括穿过其中的近侧开口。键可包括将远侧开口和近侧开口分开的桥接件。抗拉伸纤维可接合到键,延伸穿过植入式医疗装置的植入物管腔,并且靠近植入式医疗装置的远侧端部附连到该植入式医疗装置。松弛区段可定位在键的近侧。
用于将植入式医疗装置递送到身体血管的目标位置的分离系统可包括延伸穿过分离系统的管状主体的牵拉线。分离系统可包括环线,该环线在环线的远侧端部处环绕在牵拉线上。牵拉线可包括定位在环线中的环开口的近侧的松弛区段。当分离系统穿过微导管时,松弛区段可通过阻止牵拉线的远侧端部的移动来阻止植入式医疗装置的过早分离。
当牵拉线处于放松状态时,松弛区段可具有第一长度,并且当牵拉线处于张紧状态时,松弛区段可具有第二长度。当松弛区段超过第二长度时,牵拉线的远侧端部可向近侧平移。
松弛区段可以是在牵拉线中的定位在环线接触牵拉线的位置的近侧的多个弯曲部。
松弛区段可以是形成在牵拉线中的靠近环线接触拉线的位置的螺旋线圈。
松弛区段可以是可拉伸材料的区段,该可拉伸材料的区段沿着牵拉线的长度定位在环线接触牵拉线的位置的近侧。
牵拉线可由近侧刚性区段和远侧刚性区段限定,并且包括可拉伸材料的松弛区段可定位在近侧刚性区段与远侧刚性区段之间,其中近侧刚性区段和远侧刚性区段具有比可拉伸材料的区段低的弹性程度。
可拉伸材料的区段可以是聚合物缝合线。分离系统可包括靠近植入式医疗装置的近侧端部附连到植入式医疗装置的键。键可包括穿过其中的远侧开口,其中抗拉伸纤维穿过该远侧开口。键可包括穿过其中的近侧开口。键可包括将远侧开口和近侧开口分开的桥接件。抗拉伸纤维可接合到键,延伸穿过植入式医疗装置的植入物管腔,并且靠近植入式医疗装置的远侧端部附连到该植入式医疗装置。桥接件可以从环开口沿远侧方向支撑牵拉线的一部分。松弛区段可定位在键的近侧。
本文所述的方法可包括提供管状主体,该管状主体包括延伸穿过其的管腔和可压缩远侧管。该方法可包括将环线附连到管状主体。该方法可包括压缩该可压缩远侧管。该方法可包括当将环线附连到管状主体时,将环线中的环开口定位成靠近可压缩远侧管的远侧端部,使得环线延伸穿过管腔。该方法可包括使牵拉线延伸穿过管腔。该方法可包括使环开口延伸穿过植入式医疗装置的键。该方法可包括使牵拉线的远侧端部延伸穿过环开口。该方法可包括形成牵拉线的松弛区段,以当管状主体正穿过微导管时,通过阻止牵拉线的远侧端部的移动来阻止植入式医疗装置的过早分离。
当牵拉线处于放松状态时,松弛区段可具有第一长度,并且当牵拉线处于张紧状态时,松弛区段可具有第二长度,其中当松弛区段超过第二长度时,牵拉线的远侧端部向近侧平移。该方法还可包括当牵拉线回缩时释放植入式医疗装置,使得松弛区段的最终长度超过第二长度。
附图说明
将参考下面的描述并结合附图进一步讨论本发明的上述方面和另外的方面,在这些附图中,类似的编号指示各种图中类似的结构元件和特征部。附图未必按比例绘制,相反,将重点放在示出本发明的原理。附图仅以举例方式而非限制方式描绘了本发明系统的一种或多种具体实施。
图1为根据本发明的各方面的递送/分离系统和植入物的图示。
图2A和图2B为根据本发明的各方面的各自具有穿过其中的抗拉伸纤维的分离特征部(键)的图示。
图3A-图3C为根据本发明的各方面的附连到栓塞线圈的键的图示。
图4为根据本发明的各方面的定位在动脉瘤内的栓塞线圈的图示。
图5A和图5B是根据本发明的各方面的包括多个松弛弯曲部的示例性松弛区段的图示。
图6A和图6B是根据本发明的各方面的包括螺旋线圈的示例性松弛区段的图示。
图7A和图7B是根据本发明的各方面的包括可拉伸材料的示例性松弛区段的图示。
图8A-图8D示出了根据本发明的各方面的用于从分离系统释放栓塞植入物的一系列步骤。
图9为示出根据本发明的各方面的用于设计、构造或配置分离系统和植入物的步骤的流程图。
具体实施方式
本发明的一个目的是在将栓塞线圈放置在治疗部位(即,动脉瘤)之前减少栓塞线圈从分离系统的过早分离的发生或最终防止栓塞线圈从分离系统的过早分离。更具体地,本发明的一个目的是提供一定量的对牵拉线的移动的公差量,以确保牵拉线的远侧部分不会无意地向近侧平移而部署栓塞植入物。栓塞线圈递送系统的某些当前设计可包括具有压缩远侧管的管状主体,该压缩远侧管一旦从压缩中释放就将栓塞线圈递送到治疗部位。在该远侧管内(本文中也称为″远侧海波管″)穿过环线和牵拉线两者。环线可以延伸到植入物的分离特征部(在本文中也称为″键″)中并且环绕到拉线上以将远侧海波管固定到其压缩状态,同时还包含附接到键的栓塞线圈。现有设计的一个常见缺陷是有这样一种可能性:例如,当医生通过曲折递送装置时,牵拉线可能过早地从环线向近侧平移,并且反作用摩擦力导致牵拉线回缩。栓塞线圈从分离系统的过早分离可能是一个重大问题,因为医生不再控制栓塞线圈放置在动脉瘤处的时间/位置。本发明装置、系统和方法提供了对栓塞线圈的早期、无意部署的解决方案。
参考附图,图1是根据本发明的各方面的递送/分离系统10和植入式医疗装置12(其在所示示例中为栓塞线圈)的图示。植入式医疗装置12在本文中也称为植入物12。分离系统10可包括近侧管100、包括支撑线圈200的盘绕区段600、远侧管300、围绕盘绕区段600的套管500、延伸穿过盘绕区段600的环线400以及延伸穿过盘绕区段600的牵拉线140。牵拉线140的远侧端部144可至少部分地延伸超过植入物12的键18(在本文中也称为″分离特征部″)的近侧部分。分离系统10可具有由近侧管100、包括支撑线圈200的盘绕区段600和远侧管300形成的管状主体90。当远侧管300被压缩时,如下文将描述的,当远侧海波管300包括可压缩部分306时,远侧管300可被称为压缩远侧管。
近侧管100的近侧端部102可在递送构件(例如,导管250)内向近侧延伸。远侧管100的远侧端部104可连接到支撑线圈200的近侧端部202。支撑线圈200的远侧端部204可以在一个端部处连接到远侧管300,并且植入物12可以在远侧管300的远侧端部304处连接到远侧管300。近侧管100可以包括近侧腔108,盘绕区段600和支撑线圈200可以包括线圈腔208,并且远侧管300可以包括远侧腔308。近侧腔108、线圈腔208和远侧腔308提供连续的管腔,牵拉线140和环线400穿过该连续的管腔。
盘绕区段600可以主要由非不透射线的材料(诸如钢)形成,并且可以包括由不透射线的材料(诸如铂和/或钨)制成的不透射线的区段216。不透射线的区段216可被定位在支撑线圈200的近侧、非不透射线的区段和支撑线圈200的远侧、非不透射线的区段之间。可以将不透射线的区段216定位成距分离系统10的远侧端部304预先确定的距离,使得医师在治疗规程期间可以容易地可视化该系统的远侧部分的放置。近侧区段、不透射线的区段216和支撑线圈200的远侧区段可以同心焊接。
套管500可以覆盖柔性区段106的至少一部分,以在血管内导航期间抑制柔性区段的变形和/或减少与脉管系统和柔性区段106的摩擦。在一些示例中,套管500可覆盖近侧管100的约10cm,接近和/或包括近侧管100的远侧端部104。当分离系统10被组装时,盘绕区段600和套管500可比远侧海波管300和近侧海波管100更具柔性。测量柔性的一种方式是执行三点弯曲测试,其中将分离系统10的一部分在两个端点处保持固定,在这些点之间的中间位置处垂直于分离系统10施加力,并且通过由该力引起的分离系统10的挠曲长度来量化柔性。当以此方式进行测量时,在一些示例中,盘绕区段600和套管500的柔性可比远侧海波管300的柔性高约1.5倍,并且比近侧海波管100的柔性高约20倍。换句话讲,当以相同方式对三个区段100、600、300执行三点测试时,盘绕区段600可挠曲一定长度,该长度为远侧海波管300的挠曲长度的约1.5倍和近侧海波管100的挠曲长度的约20倍。如本领域的普通技术人员将会知道和理解,可以其他方式测量柔性。当分离系统10被组装时,根据通过本领域的普通技术人员已知的其他方式来确定的柔性,盘绕区段600和套管500可比远侧海波管和近侧海波管更具柔性。
环线400可以在沿着管状主体90的位置处附接到分离系统10。环线400可以包括将环线400连接到管腔108、208、308的壁的第一端附接件406和将环线400的相对端连接到管腔108、208、308的壁的第二端附接件408。第一端附件406和第二端附件408可以是将环线400连接到管状主体90的焊接件、粘合剂或其它机械紧固件。如图1所示,第一端附件406和第二端附件408可以沿着近侧海波管100定位,如图1所示,或者位于管状主体90的任何其它位置处,包括沿着盘绕区段600或近侧海波管300定位。
牵拉线140可包括沿牵拉线140的长度定位的松弛区段650。松弛区段650可提供牵拉线140的区域,该区域可在分离系统10正穿过微导管(例如,导管250)时伸展和松弛。松弛区段650可使得牵拉线140的在松弛区段远侧的区段(即,远侧刚性区段660)能够独立于牵拉线靠近松弛区段(即,近侧刚性区段658或牵拉线140的近侧端部142)的无意移动而保持静止。牵拉线140的远侧刚性区段660是牵拉线140的与环线400接合以包含植入物12的区段。下面参照图5A至图7B提供关于环线140和松弛区段650的附加细节。根据某些示例,图1所示的示例性分离系统10示出定位在线圈腔208内的松弛区段650。松弛区段650还可以定位在沿着管状主体90的长度的其他位置处,例如在近侧管腔108或远侧管腔308内。
如上所述,现有系统的一个常见问题是当系统通过曲折递送时牵拉线的无意向近侧平移。阻止远侧刚性部段660牵拉线140的向近侧平移可防止牵拉线140的无意近侧平移。远侧管300可被压缩或远侧管300的一部分可被压缩,使得一旦牵拉线140被横向牵拉足以克服可拉伸松弛区段650中的松弛,牵拉线140的远侧端部144就在环线40的端部处从环移除,并且远侧管300的压缩部分就可扩张以递送植入物12。图7A-图7B提供了远侧海波管300的可压缩部分306的详细视图。
图2A和图2B为根据本发明的各方面的各自具有穿过其中的抗拉伸纤维16的分离特征部(键18)的图示。图2A示出了具有近侧部分32的双开口键18a,该近侧部分的尺寸被设定成接合机械分离系统10和/或递送管(例如,远侧海波管300)。近侧部分32被示出为具有宽度W1。双开口键18a可具有远侧部分34,该远侧部分的尺寸被设定成配合在栓塞线圈(例如,植入物12)的管腔13内。远侧部分34可具有较宽节段和锥形节段,较宽节段的宽度W2与植入物12的内径约一样宽,锥形节段的宽度W3比植入物12的内径窄。双开口键18a可具有近侧突出部38,该近侧突出部比近侧部分32窄并且尺寸被设定成配合在递送管的管腔(例如,远侧管腔308)内。双开口键18a的″双开口″可以指键18a的面内的两个分开的开口,例如近侧开口22和远侧开口24。桥接件28可将近侧开口22和远侧开口24分开,如图所示。当分离系统10处于加载/展开前状态时,桥接件28可用于支撑牵拉线140的远侧端部144。
图2B示出了具有近侧部分32的单开口键18b,该近侧部分的尺寸被设定成接合机械分离系统10和/或递送管(例如,远侧海波管300)。近侧部分32被示出具有宽度W1。单开口键18b可具有比近侧部分32窄的远侧部分34,并且该远侧部分的尺寸被设定成配合在植入物12的管腔13内。单开口键18b可具有近侧突出部38,该近侧突出部比近侧部分32窄并且尺寸被设定成配合在递送管的管腔内,如对于双开键18a所示。
当在本文提及键18时,应理解包括双开口键18a或单开口键18b。在形成键18之后,抗拉伸纤维16可螺纹穿过双开口键18a的远侧开口24或单开口键18b的单开口26。抗拉伸纤维可为缝合材料等,可以将键固定到植入物的栓塞线圈部分。键18可在键18的近侧部分32的远侧端部处包括接合表面36。该接合表面36可邻接植入物12的近侧端部15。
图3A-图3C是根据本发明的各方面的附连到栓塞线圈(例如,植入物12)的键18的图示。具体地,图3A和图3B为键18的图示,其中远侧部分34完全插入植入物12的管腔13中,并且其中键18使用焊接件42或其他附接件附连到植入物12。焊接件52可定位在键18的接合表面36与植入物12的近侧端部15相遇的位置处。在图3A和图3B两者中,键18被示出为具有远侧部分34,该远侧部分在远侧部分34的长度的至少一部分上具有约等于植入物12的管腔13的内径的宽度。
图4为根据本发明的各方面的定位在动脉瘤A内的栓塞线圈(例如,植入物12)的图示。分离系统10通过导管250穿过血管BV到达动脉瘤A。一旦被定位,植入物12就可在动脉瘤囊内成环并且弯曲以形成血栓块。植入物12可自身环回和/或紧邻其他植入物成环。随着动脉瘤A变得越来越堆积,植入物12的重叠部分可压入彼此中。
图5A至图7B是根据本发明的各方面的牵拉线140中的示例性松弛区段650的图示。如图5A和图6A所示,牵拉线140可以是金属材料,例如钢,其具有一定的弹性程度,该弹性允许牵拉线140不仅穿过曲折部而且还提供形状记忆,并且松弛区段可以形成为牵拉线140的长度。参照图5A,松弛区段650可包括一系列左右交替的弯曲部652,其在拉伸时可伸直,而在放松时可恢复其原始的弯曲状态。图5A示出了处于放松状态的交替弯曲部652(即,尚未向近侧拉动牵拉线140),并且图5B示出了处于张紧状态的交替弯曲部652(即,已经向近侧拉动牵拉线140)。当牵拉线140处于放松状态(图5A)时,松弛区段650可具有第一长度L1,并且当牵拉线140处于张紧状态(图5B)时,松弛区段可具有第二长度L2。当松弛区段650超过第二长度L2时,牵拉线140的远侧端部144可向近侧平移。换句话说,松弛区段650在L1和L2之间的拉伸不会使远端刚性区段660平移,并且仅使松弛区段650延伸超过L2将导致牵拉线400的远侧端部144通过牵拉线140中的开口405回缩。
参照图6A,松弛区段650可包括一系列螺旋线圈654,如弹簧,其使得松弛区段650能够在近侧刚性区段658移动时拉伸和收缩,从而确保远侧刚性区段660不会过早地从环线400回缩。图6A示出了处于放松状态的螺旋线圈654(即,尚未向近侧拉动牵拉线140),并且图6B示出了处于张紧状态的螺旋线圈654(即,已经向近侧拉动牵拉线140)。当牵拉线140处于放松状态(图6A)时,松弛区段650可具有第一长度L1,并且当牵拉线140处于张紧状态(图6B)时,松弛区段可具有第二长度L2。如上所述,当松弛区段650超过第二长度L2时,牵拉线140的远侧端部144可向近侧平移。
参考图7A,松弛区段650可以是沿着牵拉线140的长度定位的可拉伸材料656。可拉伸材料656可包括聚合物缝合线、另一种合成或天然纤维等。类似于上述弯曲部652和螺旋线圈654,当近侧刚性区段658移动时,可拉伸材料656可使得松弛区段650伸展和收缩,从而确保远侧刚性区段660不会过早地从环线400回缩。当牵拉线140处于放松状态(图7A)时,松弛区段650可具有第一长度L1,并且当牵拉线140处于张紧状态(图7B)时,松弛区段可具有第二长度L2。如上所述,当松弛区段650超过第二长度L2时,牵拉线140的远侧端部144可向近侧平移。
远侧刚性区段660、近侧刚性区段658和松弛区段650均可沿这三个区段的长度包括相同的材料。例如,上述弯曲部652和/或螺旋线圈654可由与远侧刚性区段660和近侧刚性区段658相同的材料制成。然而,这些区段可以包括不同的材料。例如,远侧刚性区段660和近侧刚性区段658可由弹性较小的材料(即,较高的杨氏模量)制成,诸如钢、铬合金等。松弛区段可包括更具弹性的材料,例如钛、镍合金等。更有弹性的松弛区段650可在牵拉线140的部分处提供更大的挠曲和拉伸,以便进一步减小与环线400接合的远侧刚性区段660的过早向近侧平移的机会。在松弛区段650是可拉伸材料656的情况下,可拉伸材料656可以是与远侧刚性区段660和近侧刚性区段658不同的材料。
图8A-图8D示出了根据本发明的各方面的用于从分离系统10释放栓塞植入物12的一系列步骤。图8A为植入物12和被构造成用于递送和定位植入物12的递送管(例如,远侧海波管300)的图示。图8B至图8D示出了从远侧海波管300释放示例性栓塞植入物12。为了进行示意性的说明,切除远侧海波管300的一部分。图中未示出管状主体90的更近侧特征部。
图8A示出了包括被锁定到植入物12的键18中的牵拉线140和环线400的分离系统(图8A和图8D中示出的键是双开口键18a,但是图示可以等同地应用于单开口键18b)。远侧管300可包括可压缩部分306。如上所述,松弛区段650在分离系统10中可位于远侧管300的近侧,并且松弛区段650在图8A至图8D所示的视图中不可见。环线400可在环线400的远侧端部404处具有开口405,并且开口405可被放置成穿过键18中的开口(例如,双开口键18a中的近侧开口22,或单开口键18b中的单个开口26)。当牵拉线140被放置成穿过开口405时,植入物12现在是固定的。
在双开口键18a的情况下,键可包括桥接件28,该桥接件定位在环线开口405的远侧并且定位成支撑牵拉线140的远侧部分,该远侧部分在牵拉线140包住环线开口405的位置的远侧。如此构造,桥接件28可支撑牵拉线140的远侧部分,使得当环线400在环开口405处抵靠牵拉线140张紧时,桥接件28可组织牵拉线140的远侧部分变形。键18的近侧突出部38可定位成支承牵拉线140的一部分,该部分在牵拉线140支承环线开口405的位置的近侧。桥接件28和近侧突出部38的组合可阻止牵拉线140(即,远侧刚性区段660)因环线400所施加的力而变形。在穿过脉管系统递送植入物12期间并且当植入物12定位在治疗部位处时,远侧海波管300能够可拆卸地附接到植入物12,如图8A所示。桥接件28可降低植入物12由于来自环线400的力引起的牵拉线140的弯曲而过早释放的可能性。
图8B示出了朝近侧拉动牵拉线140以开始植入物12的释放序列。如上所述,由于该视图示出了牵拉线的远侧端部144正向近侧平移,这意味着足够的张力被施加在近侧刚性区段658上,松弛区段650延伸超过L2(在图6A和6B中示出)。图8C示出牵拉线140离开开口405并被拉出环线400的瞬间。环线400的远侧端部404脱离并离开键18。可以看出,现在没有任何东西将植入物12保持到远侧海波管300。图8D示出了释放序列的结束。在此,可压缩部分306已经伸展/恢复到其原始形状并且向前″弹出″。远侧海波管300的远侧端部304向植入物12施加弹力E,以将其″推开″,从而确保植入物12的完全分离和递送。可压缩部分306可以是远侧海波管300的螺旋切割部分,例如装载分离系统10时可被压缩的激光切割螺旋段。
图9为示出根据本发明的各方面的用于设计、构造或配置分离系统和植入物的方法900的流程图。步骤904至932描述了产生/构造本文所述的一个或多个分离系统10的步骤。在步骤904中,分离系统10的构造可以从提供管状主体90开始,该管状主体包括延伸穿过其的管腔(例如,管腔108、208、308)和可压缩远侧管(例如,远侧海波管300)。在步骤908中,环线400可附连到管状主体90。例如,环线的近侧端部可在第一端附接件406和第二端附接件408处附接到管状主体。
在步骤912中,可压缩远侧管300可被压缩成其加载构型。在步骤916处,环线400中的环线开口405可以靠近可压缩远侧管的远侧端部304定位,使得环线400延伸穿过管腔(例如(例如,管腔108、208、308)。在步骤920中,牵拉线140可延伸穿过管腔(例如,管腔108、208、308)。
在步骤924中,环开口405可延伸穿过植入式医疗装置12的键18。在步骤928中,牵拉线140的远侧端部144可延伸穿过环线140的环开口405。在步骤932处,松弛区段650可形成于牵拉线140中。松弛区段650可以是本文所述的松弛区段中的任一种或任何类似的松弛区段,其使得当分离系统正穿过微导管时,牵拉线140的近侧端部142能够独立于牵拉线140的远侧端部144向近侧和向远侧平移。
用于产生/构造分离系统10的步骤可以在步骤932之后结束。在一些示例中,步骤936和940提供额外的步骤以阻止牵拉线140的无意向近侧平移并且使得植入物可被部署。例如,在步骤936中,当植入式医疗装置12通过脉管系统递送到治疗部位时,牵拉线140通过环线400的向近侧平移可经由阻止牵拉线140的远侧端部144的移动来抑制。在步骤940中,可提供足够的力以将松弛区段650拉伸超过松弛区段650可拉伸的最终长度,而不移动牵拉线140的远侧端部144(例如,上述L2)。
如本文所用,针对任何数值或范围的术语″约″或″大约″指示允许部件或元件的集合实现如本文所述的其预期要达到的目的的合适的尺寸公差。更具体地,″约″或″大约″可指列举值的值±20%的范围,例如″约90%″可指从71%到99%的值范围。
本文所包含的描述是本发明的实施方案的示例,并且不旨在以任何方式限制本发明的范围。如本文所述,本发明设想了植入物及其制造和使用方法的许多变型和修改,包括另选的材料,组成部件的另选的几何形状,组成部件相对于彼此的另选的定位等。对于本发明所属领域的普通技术人员而言显而易见的是,本发明应包括在所附权利要求书的范围内。
Claims (19)
1.一种用于将植入式医疗装置递送到身体血管的目标位置的分离系统,所述系统包括:
管状主体,所述管状主体包括延伸穿过其的管腔和压缩远侧管;环线,所述环线包括附连到所述管状主体的第一端部并包括定位成靠近所述压缩远侧管的远侧端部的环开口;和
牵拉线,所述牵拉线延伸穿过所述管腔并穿过所述环开口,其中所述牵拉线包括定位在所述管腔内的松弛区段,使得当所述分离系统正穿过微导管时,所述牵拉线的近侧端部能够独立于所述牵拉线的远侧端部向近侧和向远侧平移。
2.根据权利要求1所述的分离系统,当所述牵拉线处于放松状态时,所述松弛区段具有第一长度,并且当所述牵拉线处于张紧状态时,所述松弛区段具有第二长度,其中当所述松弛区段超过所述第二长度时,所述牵拉线的所述远侧端部向近侧平移。
3.根据权利要求1所述的分离系统,其中当所述分离系统正穿过微导管时,所述松弛区段通过阻止所述牵拉线的所述远侧端部的移动而有效地阻止所述植入式医疗装置的过早分离。
4.根据权利要求1所述的分离系统,其中所述松弛区段是所述牵拉线中的多个弯曲部,所述多个弯曲部定位在所述环线接触所述牵拉线的位置的近侧。
5.根据权利要求1所述的分离系统,其中所述松弛区段是在所述环线接触所述牵拉线的位置的近侧形成到所述牵拉线中的螺旋线圈。
6.根据权利要求1所述的分离系统,其中所述松弛区段是可拉伸材料的区段,所述可拉伸材料的区段沿着所述牵拉线的长度定位在所述环线接触所述牵拉线的位置的近侧。
7.根据权利要求6所述的分离系统,其中所述牵拉线由近侧刚性区段和远侧刚性区段限定,并且所述可拉伸材料的区段定位在所述近侧刚性区段与所述远侧刚性区段之间,其中所述近侧刚性区段和所述远侧刚性区段具有比所述可拉伸材料的区段低的弹性程度。
8.根据权利要求6所述的分离系统,其中所述可拉伸材料的区段是聚合物缝合线。
9.根据权利要求1所述的分离系统,还包括:
键,所述键靠近所述植入式医疗装置的近侧端部附连到所述植入式医疗装置,并且包括:
穿过所述键的远侧开口,其中抗拉伸纤维穿过所述远侧开口;
穿过所述键的近侧开口;和
桥接件,所述桥接件将所述远侧开口和所述近侧开口分开;和
所述抗拉伸纤维,所述抗拉伸纤维接合到所述键,延伸穿过所述植入式医疗装置的植入物管腔,并且靠近所述植入式医疗装置的远侧端部附连到所述植入式医疗装置,
其中所述松弛区段定位在所述键的近侧。
10.一种用于将植入式医疗装置递送到身体血管的目标位置的分离系统,所述系统包括:
牵拉线,所述牵拉线延伸穿过所述分离系统的管状主体;和
环线,所述环线在所述环线的远侧端部处环绕在所述牵拉线上,其中所述牵拉线包括定位在所述环线中的环开口的近侧的松弛区段,当所述分离系统正穿过微导管时,所述松弛区段通过阻止所述牵拉线的远侧端部的移动而有效地阻止所述植入式医疗装置的过早分离。
11.根据权利要求10所述的分离系统,其中当所述牵拉线处于放松状态时,所述松弛区段具有第一长度,并且当所述牵拉线处于张紧状态时,所述松弛区段具有第二长度,其中当所述松弛区段超过所述第二长度时,所述牵拉线的所述远侧端部向近侧平移。
12.根据权利要求10所述的分离系统,其中所述松弛区段是所述牵拉线中的多个弯曲部,所述多个弯曲部定位在所述环线接触所述牵拉线的位置的近侧。
13.根据权利要求10所述的分离系统,其中所述松弛区段是在所述环线接触所述牵拉线的位置的近侧形成到所述牵拉线中的螺旋线圈。
14.根据权利要求10所述的分离系统,其中所述松弛区段是可拉伸材料的区段,所述可拉伸材料的区段沿着所述牵拉线的长度定位在所述环线接触所述牵拉线的位置的近侧。
15.根据权利要求14所述的分离系统,其中所述牵拉线由近侧刚性区段和远侧刚性区段限定,并且所述可拉伸材料的区段定位在所述近侧刚性区段与所述远侧刚性区段之间,其中所述近侧刚性区段和所述远侧刚性区段具有比所述可拉伸材料的区段低的弹性程度。
16.根据权利要求14所述的分离系统,其中所述可拉伸材料的区段是聚合物缝合线。
17.根据权利要求10所述的分离系统,还包括:
键,所述键靠近所述植入式医疗装置的近侧端部附连到所述植入式医疗装置,并且包括:
穿过所述键的远侧开口,其中抗拉伸纤维穿过所述远侧开口;
穿过所述键的近侧开口;和
桥接件,所述桥接件将所述远侧开口和所述近侧开口分开;和
所述抗拉伸纤维,所述抗拉伸纤维接合到所述键,延伸穿过所述植入式医疗装置的植入物管腔,并且靠近所述植入式医疗装置的远侧端部附连到所述植入式医疗装置,
其中所述桥接件从所述环开口沿远侧方向支撑所述牵拉线的一部分,并且
其中所述松弛区段定位在所述键的近侧。
18.一种方法,包括:
提供管状主体,所述管状主体包括延伸穿过其的管腔和可压缩远侧管;
将环线附连到所述管状主体;
压缩所述可压缩远侧管;
当将所述环线附连到所述管状主体时,将所述环线中的环开口定位成靠近所述可压缩远侧管的远侧端部,使得所述环线延伸穿过所述管腔;
使牵拉线延伸穿过所述管腔;
使所述环开口延伸穿过植入式医疗装置的键;
使所述牵拉线的远侧端部延伸穿过所述环开口;以及
形成所述牵拉线的松弛区段,以当所述管状主体正穿过微导管时,通过阻止所述牵拉线的所述远侧端部的移动来阻止所述植入式医疗装置的过早分离。
19.根据权利要求18所述的方法,其中当所述牵拉线处于放松状态时,所述松弛区段具有第一长度,并且当所述牵拉线处于张紧状态时,所述松弛区段具有第二长度,其中当所述松弛区段超过所述第二长度时,所述牵拉线的所述远侧端部向近侧平移,所述方法还包括:
当所述牵拉线回缩时释放所述植入式医疗装置,使得所述松弛区段的最终长度超过所述第二长度。
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2021
- 2021-12-30 US US17/566,287 patent/US11937824B2/en active Active
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2022
- 2022-12-28 JP JP2022211620A patent/JP2023099348A/ja active Pending
- 2022-12-28 KR KR1020220186826A patent/KR20230104007A/ko unknown
- 2022-12-29 EP EP22217163.9A patent/EP4205669A1/en active Pending
- 2022-12-30 CN CN202211728743.1A patent/CN116421249A/zh active Pending
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CN117442258A (zh) * | 2023-12-22 | 2024-01-26 | 北京迈迪顶峰医疗科技股份有限公司 | 输送装置及其绑定方法 |
CN117442258B (zh) * | 2023-12-22 | 2024-04-23 | 北京迈迪顶峰医疗科技股份有限公司 | 输送装置及其绑定方法 |
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US20240138843A1 (en) | 2024-05-02 |
US11937824B2 (en) | 2024-03-26 |
US20230210533A1 (en) | 2023-07-06 |
JP2023099348A (ja) | 2023-07-12 |
EP4205669A1 (en) | 2023-07-05 |
KR20230104007A (ko) | 2023-07-07 |
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