CN112807046A - 具有编织杯形成物的植入物递送系统 - Google Patents
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Abstract
本发明题为“具有编织杯形成物的植入物递送系统”。本文所述的植入物系统包括接合线、牵拉线和其上具有远侧环的编织植入物。所述接合线具有细长构件,所述细长构件在其远侧端部处具有径向延伸的接合特征部。所述编织物可从被定尺寸成横穿导管的递送形状移动成被定尺寸成闭塞动脉瘤颈部的植入形状。当所述编织物处于所述递送形状时,所述牵拉线和所述细长构件延伸穿过所述远侧环,并且所述接合特征部相对于所述远侧环处于远侧方向。一旦所述编织物的至少一部分定位在所述动脉瘤中,所述牵拉线和所述细长构件就可沿近侧方向移动以使所述接合特征部接合到所述远侧环并且使所述远侧环朝近侧移动,从而使所述编织物在所述动脉瘤内再成形。
Description
技术领域
本发明整体涉及医疗器械,并且更具体地,涉及用于动脉瘤治疗的植入物系统。
背景技术
本发明整体涉及医疗装置,并且更具体地涉及用于治疗血管缺陷的植入物系统和方法。例如,本发明可涉及用于治疗动脉瘤的植入物系统和方法。动脉瘤是由血管壁弱化引起的血管扩张。扩张由正常血流施加的压力产生,这可导致血管的弱化段肿胀。在一些情况下,这种肿胀导致从主血管或母血管突出的囊或球囊状息肉。球囊动脉壁的持续生长和/或最终破裂可对患者具有灾难性结果。因此,应当治疗未破裂的动脉瘤以防止出血。另外,可治疗破裂的动脉瘤以避免后续破裂和/或另外的损害。
用于治疗动脉瘤的一些已知的医疗装置和治疗方法包括将一个或多个栓塞线圈填充到动脉瘤的囊中。在一些治疗中,铂栓塞线圈与递送线电解分离,从而在线圈中诱导电荷,这可在动脉瘤中引起血栓形成效应。然而,对于具有起搏器或类似装置的患者而言,使用电力将线圈与递送系统分离是不可取的。在其它治疗中,栓塞线圈与递送管机械分离。遗憾的是,复发是已知手术中常见的问题,这意指血流返回到动脉瘤并且可导致线圈填充的动脉瘤进一步肿胀。另外,此类已知的装置和方法需要延长患者的手术时间,并且相应地增加患者的辐射暴露。此外,此类装置和方法不治疗动脉瘤的颈部,该动脉瘤的颈部是动脉瘤的干血管与囊之间的区域。
另一种已知的治疗方法包括使用栓塞线圈和支架两者。如上所述,将线圈递送到动脉瘤的囊,并且将支架定位在母血管内,使得支架的一部分设置在动脉瘤的颈部上方。通常需要支架来治疗宽颈动脉瘤,以阻止栓塞线圈突出到母血管中。此类手术具有若干缺点。举例来说,递送两种单独类型的装置(即,线圈和支架)是更复杂的过程,这通常导致患者的更长手术时间。支架可导致血管的支架内狭窄。另外,患者还很可能需要在手术后无限期地服用血液稀释剂。此外,此类装置和方法不适用于治疗定位在血管分叉处(即,在血管的相邻分支之间)的动脉瘤。
另一种已知的装置和治疗方法包括使用分流器,该分流器被递送到邻近动脉瘤颈部的干血管。最常见的是,将分流器定位在动脉瘤的颈部上方的母血管内,以防止附加血流从血管流入动脉瘤。在当前的手术中,通常每个动脉瘤需要多于一个分流器以确保血流从动脉瘤适当地分流。此类装置和治疗方法与上述支架的使用具有类似的缺点。具体地讲,分流器可导致血管的狭窄,并且患者将可能需要在手术之后无限期地服用血液稀释剂。另外,许多已知的分流器不适用于治疗定位在血管分叉处的动脉瘤。此外,使用分流器治疗的患者的长期随访显示动脉瘤的血管再通率增加。
因此,需要用于治疗血管缺陷(诸如球囊型动脉瘤)的改善的系统、装置和方法,如本文所述。
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。
示例性植入物系统可具有接合线、牵拉线和其上具有远侧环的植入物,使得接合线和牵拉线被构造成接合远侧环以使植入物再成形并且在植入物再成形之后使远侧环脱离接合。接合线可具有细长构件和设置在细长构件的远侧端部处的接合特征部。植入物可具有编织物,该编织物能够从被定尺寸成横穿导管的递送形状移动成被定尺寸成闭塞动脉瘤颈部的植入形状。远侧环可附连到编织物。当编织物处于递送形状时,牵拉线和细长构件可延伸穿过远侧环,并且接合特征部可相对于远侧环处于远侧方向。牵拉线和细长构件能够沿近侧方向移动,从而使接合特征部接合到远侧环并使远侧环朝近侧移动。在远侧环朝近侧移动时,编织物能够从递送形状移动成植入形状。
在一些示例中,植入物还可包括附连到编织物的近侧环。当编织物处于递送形状时,牵拉线和细长构件可延伸穿过近侧环,并且近侧环可相对于远侧环沿近侧方向定位。
在一些示例中,植入物系统可包括可拆卸地附接到植入物的递送管。该系统可包括附连到递送管的环线。植入物可包括脱离特征部,该脱离特征部具有穿过该脱离特征部的开口。环线可延伸穿过脱离特征部中的开口。牵拉线和细长构件中的一者或两者可延伸穿过环线以阻止环线离开脱离特征部中的开口。在牵拉线延伸穿过环线的示例中,牵拉线能够移动以离开环线。除此之外或另选地,在细长构件延伸穿过环线的示例中,细长构件和接合特征部能够移动以离开环线。当牵拉线和细长构件两者均不含环线时,环线能够移动以离开脱离特征部中的开口。
在一些示例中,递送管可包括靠近其远侧端部的凹口。脱离特征部可定位在凹口内。脱离特征部可关于一个或多个轴线不对称。
在一些示例中,植入物系统可包括中空推杆,该中空推杆被构造成接合植入物的近侧环。代替递送管和脱离特征部,或除了递送管和脱离特征部之外,中空推杆还可用于朝远侧平移植入物。中空推杆可具有内径,该内径大于牵拉线的直径和细长构件的直径的总和。接合特征部可具有小于远侧环的内径的直径,以允许接合特征部穿过远侧环。远侧环的内径可大于牵拉线的直径和细长构件的直径的总和,使得牵拉线和接合线的细长构件部分两者均可穿过远侧环。远侧环的内径可小于牵拉线的直径和接合特征部的直径的总和,使得当牵拉线和细长构件两者延伸穿过远侧环时,阻止接合特征部穿过远侧环。
用于构造具有远侧环和用于递送的管状编织物的植入物的示例性方法可包括以非特定顺序呈现的以下步骤中的一者或多者,并且该方法可包括此处未包括的附加步骤。该方法可包括将植入物的远侧环定位在管状编织物的远侧端部上。另外,接合特征部可被定位成从细长构件的远侧端部径向延伸。细长构件可延伸穿过管状编织物的管腔和远侧环的管腔。另外,牵拉线可延伸穿过管状编织物的管腔和远侧环的管腔,使得牵拉线阻止接合特征部穿过远侧环的管腔。该方法还可包括使接合特征部沿近侧方向回缩以将植入物固定在动脉瘤内。牵拉线可从植入物沿近侧方向回缩。此外,接合特征部可从植入物沿近侧方向回缩,使得植入物与至少牵拉线和接合特征部脱离接合,并且使植入物从递送管脱离接合。该方法还可包括将具有穿过其的细长构件和牵拉线的植入物定位在递送导管内,使得接合特征部相对于远侧环沿远侧方向定位。近侧环可附接到管状编织物的近侧端部,并且细长构件和牵拉线可延伸穿过近侧环的管腔。
在一些示例中,该方法还可包括将脱离特征部附接到近侧环,将脱离特征部可拆卸地附接到递送管,以及将脱离特征部定位在递送管的远侧端部处的凹口中。该方法还可包括将环线附接到递送管,使环线延伸穿过脱离特征部的开口,以及使至少牵拉线或细长构件延伸穿过环线的孔。除此之外或另选地,该方法可包括将中空推杆的远侧端部接合到近侧环,使得中空推杆被构造成在治疗期间脱离接合近侧环。
用于定位植入物的示例性方法可包括以非特定顺序呈现的以下步骤中的一者或多者,并且该方法可包括此处未包括的附加步骤。该方法可包括将其上包括远侧环的植入物定位在递送导管内。此外,牵拉线和其上具有接合特征部的细长构件可定位成穿过远侧环的管腔,使得接合特征部相对于远侧环沿远侧方向定位,并且使得牵拉线阻止接合特征部穿过远侧环的管腔。此外,植入物可延伸穿过动脉瘤的颈部。该方法还可包括通过使细长构件在牵拉线延伸穿过远侧环的同时回缩来使植入物在动脉瘤内再成形。这使得接合特征部接合远侧环并且使远侧环朝近侧移动。此外,牵拉线可从植入物沿近侧方向回缩。该方法还可包括使接合特征部沿近侧方向从植入物回缩,使得植入物与至少牵拉线和接合特征部脱离接合,并且使植入物与递送管脱离接合。
在一些示例中,该方法还可包括将递送管接合到植入物,将递送管、植入物、牵拉线和细长构件定位在递送导管内,以及通过朝远侧推动递送管来使植入物朝远侧移动穿过递送导管。该方法还可包括通过首先使牵拉线从附接到递送管的环线中的开口回缩并且随后使细长构件从该开口回缩从而使得环线脱离接合植入物,来使递送管与植入物脱离接合。除此之外或另选地,该方法还可包括将递送管相对于近侧环沿近侧方向定位,该近侧环被设置成接近植入物的近侧端部,其中递送管为中空推杆。另外,可将牵拉线和细长构件定位在中空推杆的管腔内和近侧环的管腔内。该方法还可包括沿远侧方向抵靠近侧环推动中空推杆,从而使植入物朝远侧移动穿过递送导管。此外,可将近侧环保持在递送导管内,同时使植入物延伸穿过动脉瘤的颈部,并且同时通过使细长构件回缩来使该植入物再成形。此外,细长构件可在牵拉线延伸穿过远侧环时回缩。该方法还可包括使中空推杆接合到近侧环,同时通过使细长构件在牵拉线延伸穿过远侧环时回缩来使该植入物再成形。另外,牵拉线可沿近侧方向从远侧环回缩,以从远侧环的管腔移除牵拉线。该方法还可包括当牵拉线从远侧环移除时,使接合特征部沿近侧方向穿过远侧环回缩。此外,牵拉线可沿近侧方向穿过近侧环回缩。该方法还可包括使接合特征部沿近侧方向穿过近侧环回缩,以及使中空推杆沿近侧方向回缩,从而使中空推杆与近侧环脱离接合。
在一些示例中,该方法还可包括将植入物固定在动脉瘤内。
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装置的一种或多种具体实施。
图1是根据本发明的各方面的部署在动脉瘤的横截面内的系统的图示;
图2A至图2C是根据本发明的各方面的植入物和递送系统的示例性远侧端部的图示;
图3A和图3B是根据本发明的各方面的在示例性系统中与植入物脱离的递送系统的剖视图的图示;
图4是根据本发明的各方面的示例性系统的剖视图的图示;
图5A至图5C是根据本发明的各方面的分别在动脉瘤外部处于预定状态的示例性植入物、在动脉瘤的横截面内处于部署状态的示例性植入物和处于变形/递送构型的示例性植入物的图示;
图6A至图6D是根据本发明的各方面的示例性系统的部署顺序的图示;
图7A和图7B是根据本发明的各方面的用于将示例性植入物部署到动脉瘤中的示例性系统的横截面的图示;
图8是概述根据本发明的各方面的在部署示例性植入物期间可执行的示例性方法步骤的流程图;并且
图9是概述根据本发明的各方面的用于构建示例性系统的示例性方法步骤的流程图。
具体实施方式
一般来讲,本文所述的示例性系统可包括植入物和递送系统,该植入物具有其上带远侧环的可膨胀主体,该递送系统被构造成使植入物在动脉瘤中定位和成形。植入物可为能够从变形构型膨胀成部署构型的编织物,在该变形构型中,植入物被成形以通过微导管递送到动脉瘤治疗部位,在该部署构型中,植入物被成形以从动脉瘤囊内闭塞动脉瘤。递送系统可包括牵拉线和接合线,该牵拉线和接合线被构造成穿过远侧环的管腔和编织物的管腔。牵拉线和接合线可一前一后回缩以将编织物移动成杯形部署构型,从而提供机械装置以调节囊内的植入物。接合线可在其远侧端部处具有珠缘或其它此类接合特征部,其尺寸被设定成穿过衬圈,并且牵拉线的尺寸可被设定成使得当牵拉线和接合线两者被定位成穿过远侧环的管腔时,阻止接合特征部穿过远侧环。该系统还可被构造成使得牵拉线和/或接合线用于从递送系统机械地释放植入物。
图1示出了示例性系统的剖视图。如图所示,该系统可具有可拆卸地附接到递送系统200的植入物100。植入物100可具有编织物110、近侧环122和远侧环124。近侧环122和远侧环124中的每一者可包含射线不可透材料以有助于在治疗期间定位植入物。每个环122、124可焊接、胶合或以其它方式附连到编织物110。
编织物110可由形状记忆合金构造,例如镍钛诺或其它合适的记忆形状材料。编织物110可具有预定构型、变形构型和部署构型。编织物110的预定构型是编织物110被训练以记住例如经由热处理使用的构型。预定构型可以为杯状或碗状形状。编织物110的变形构型是当编织物110位于引导导管310内时该编织物110具有的构型。在变形构型中,编织物110可被拉伸成细长管状形状。编织物110可从预定构型移动到变形构型,使得编织物110的尺寸被设定成横穿导管310到动脉瘤10。编织物110的部署构型可基于预定构型或预定构型的变型,例如不对称杯状构型。部署构型可以为预定构型的突变,这意指当编织物110在动脉瘤10内移动以返回到预定构型时,其可接触动脉瘤10的壁14并被该壁约束,从而导致预定构型的偏差并产生部署构型。
递送系统200可具有递送管210、牵拉线220和接合线230。递送系统200可用于在动脉瘤10内定位和部署植入物100。引导导管310可用于提供将植入物100递送到动脉瘤10和/或有助于在动脉瘤10内定位和部署植入物100的装置。
图2A至图2C是用于帮助植入物100从变形构型再成形为部署构型的示例性系统的远侧端部的图示。如图所示,在图2A中,接合线230可具有细长构件236,该细长构件具有附接到细长构件236的远侧端部的接合特征部238。如图所示,牵拉线220和细长构件236被构造成以平行构型穿过远侧环124的管腔128。然而,接合线230可仅穿过如此远,因为接合特征部238不能穿过管腔128,同时牵拉线220也占据管腔128。需注意,牵拉线220和接合线230可为实心的或中空的,并且由具有足以允许过盈配合的特性的材料制成。
图2B为从远侧环124的管腔128回缩的牵拉线220的图示。该位置是释放编织物110的开始,并且接合线230上的近侧力将释放植入物100。然而,即使过盈配合已被释放,其仍可通过使牵拉线220往回穿过管腔128移动而重新接合。这允许医师在丧失使编织物110进一步移动或变形的所有能力之前验证植入物100在动脉瘤10中的放置。
图2C为图2A的剖视图。细长构件236可具有细长构件直径D5。接合特征部238可具有接合特征部直径D1。牵拉线220可具有牵拉线直径D2。牵拉线直径D2和接合特征部直径D1的总和可为总直径D12。远侧环124具有环内径D4。应当注意,总直径D12大于环内径D4,这导致过盈配合,从而直到牵拉线220首先回缩,才允许接合特征部238穿过远侧环124的管腔128回缩。在该构型中,清楚地看到接合特征部直径D1小于环内径D4,从而允许接合线230从远侧环124的管腔128回缩。从上文证实了不同的关系,因为D2+D5<D4并且D1+D2=D12>D4。
图3A和图3B为与植入物100脱离的递送系统200的图示,其中图3A示出可拆卸地附接到递送系统200的植入物100,并且图3B示出在脱离植入物100之后不久的植入物100和递送系统200。
共同参见图3A和图3B,植入物可包括附连到其上的脱离特征部123,该脱离特征部被成形为并且以其它方式被构造成可拆卸地接合递送系统200。植入物100还可包括近侧环122。脱离特征部123和/或近侧环122可由射线不可透材料构造以有助于植入物100的放置的可视化。近侧环122可用于约束编织物110的近侧端部,并且/或者近侧环122可提供有助于将编织物110固定到脱离特征部123的结构。
如图3A所示,当植入物100附接到递送系统200时,牵拉线220和接合线230可被构造成彼此平行并且被构造成穿过环线218的孔218a、近侧环122的管腔126和编织物110的管腔125。环线218可附接到递送管210并且可穿过脱离特征部123的开口123a。在该构型中,环线218将脱离特征部123可拆卸地固定到递送管210。脱离特征部123可附接到植入物100的近侧环122并且可拆卸地附接到递送管210中的凹口216(参见图4)。凹口216可设置在递送管210的远侧端部214上。
递送管210可由生物相容性材料诸如不锈钢制成。管210的尺寸可被设定成适用于将植入物100递送和部署到动脉瘤10,如本文所述。
如图3B所示,牵拉线220和接合线230可从环线218的孔218a朝近侧回缩并进入递送管210中。在牵拉线220和接合线230回缩到递送管210中时,环线218从脱离特征部123的开口123a脱落并且不再将脱离特征部123固定到递送管210,从而使得脱离特征部123能够从递送管210脱离。
在一些示例中,环线218可相对较小,其具有毛发的厚度,因此可优选地使环线完全屏蔽在递送管210内以防止由意外接触造成的损害。环线218可以为弯曲以形成开口的细长线。另选地,环线218可以为具有开口的单个细长线。环线218可由多种材料(包括镍钛诺和不锈钢)形成。
图4为图3A的侧剖视图。如图所示,可看出脱离特征部123可拆卸地附接到位于递送管210的远侧端部214处的凹口216。另外,可看到脱离特征部123附接到近侧环122。可看到牵拉线220和接合线230穿过环线218的孔218a。可看到环线218穿过脱离特征部123的开口123a并且将脱离特征部123固定到凹口216。
图5A至图5C是示例性植入物100的图示,其分别在动脉瘤10外部处于预定构型,在动脉瘤10的横截面内处于部署构型。示例性植入物100可具有编织物110、近侧环122、远侧环124和脱离特征部123,诸如本文所示和/或所述的或由本领域的普通技术人员已知的其它特征部。近侧环122可设置在编织物110的近侧端部112上,并且远侧环124可设置在编织物110的远侧端部114上。如上文所公开的,脱离特征部123可具有开口123a。
如图5A所示,在预定形状中,编织物110可具有碗形或杯形。远侧环124和近侧环122可沿编织物110的中心轴线定位。编织物110可被折叠成使得碗限定两个嵌套的碗。远侧环124和近侧环122可分别定位在每个嵌套碗形状的槽处。
如图5B所示,植入物100的编织物110一旦处于部署构型,就可具有折叠部117、内囊116、外囊118。折叠部117可以是编织物110的弯曲部,其将内囊116从外囊118中描绘出来。外囊118可接触动脉瘤10的壁14。
编织物110可包括记忆形状材料,并且可被热定形或以其它方式定形以形成预定形状。当变形时,由于来自接触血液或其它体液的热量,编织物110可被激活以移动成预定形状。另选地,编织物110不需要包括记忆形状材料,并且诸如本文所示和所述的递送系统200可足以将编织物110从如图5C所示的变形形状移动到如图5B所示的部署构型。
如图5C所示,在变形构型下,植入物100可塌缩和/或伸长以适配在引导导管310内。
图6A至图6D为示例性递送系统200和植入物100的部署序列的图示。如图6A所示,植入物100在其离开导管310时开始从动脉瘤10内的变形构型膨胀。在图6A中,牵拉线220和接合线230两者被定位成穿过近侧环122的管腔126、编织物110的管腔125和远侧环124的管腔128。牵拉线220和接合线230可处于先前相对于图2A所讨论的平行构型或以其它方式定位,如本文所述。如图6B所示,接合线230和牵拉线220可沿近侧方向回缩,使得远侧环124沿近侧方向移动更靠近近侧环122。当接合线230和牵拉线220回缩时,编织物110从变形构型重新构造成部署构型,使得外囊118接触动脉瘤10的壁14。植入物100可包括记忆形状材料,并且植入物100可至少部分地基于植入物100的预定形状再成形。另选地,在一些示例中,编织物110不需要包括记忆形状材料,并且在此类情况下,接合线230和牵拉线220的移动可足以使编织物110再成形为部署形状。
如图6C所示,牵拉线220可沿近侧方向回缩到递送管210中。可沿远侧方向进行接合线230的略微调节以允许牵拉线220回缩。牵拉线220可被构造成穿过远侧环124的管腔128、编织物110的管腔125、近侧环122的管腔126和环线218的孔218a。关于回缩的更多细节先前在图2A至图2C中讨论。
如图6D所示,接合线230可沿近侧方向回缩到递送管210中。接合线230被构造成穿过远侧环124的管腔128、编织物110的管腔125、近侧环122的管腔126和环线218的孔218a。关于回缩的更多细节先前在图2A至图2C中讨论。
图7A和图7B是用于将示例性植入物100部署到动脉瘤10中的另选的示例性递送系统200的横截面的图示。
如图7A所示,中空推杆320的远侧端部324可接合植入物100的近侧环122。中空推杆320的管腔326的尺寸可被设定成允许接合线230和牵拉线220穿过中空推杆320。中空推杆320可沿远侧方向推动,从而导致接合的植入物100也朝向引导导管310的远侧端部314朝远侧推动并离开该引导导管。植入物100可处于变形构型,诸如图5C所示。引导导管内径D7的尺寸可被设定成允许中空推杆320和植入物100穿过引导导管310的管腔316。推杆内径D6被构造成使得其大于或等于总直径D12。
如图7B所示,当接合线230和牵拉线220沿近侧方向缩回到中空推杆320中时,中空推杆320的远侧端部324可保持与近侧环122接合。作为反应的结果,植入物100可从图7A所示的变形构型移动到此处所示的部署构型。编织物110的近侧端部可保持在引导导管310内,直到编织物110完全部署在动脉瘤内之后。在部署编织物110之后,牵拉线220,然后接合线230可回缩。一旦牵拉线220和接合线230从植入物100脱离接合,则导管310就可回缩,从而完成植入。
上述附图中的图示大致描绘了根据本发明的中空的递送管210。当在本文中使用时,术语“管状”和“管”应广义地理解,并且不限于为正圆柱体的或横截面为完全圆周的或在其整个长度上具有均匀横截面的结构。例如,管状结构或系统通常被示出为基本上呈正圆柱体的结构。然而,在不脱离本发明范围的情况下,管状系统可具有锥形或弯曲外表面。
图8示出用于构建或构造植入物和递送系统诸如如本文所述的示例性植入物100和/或示例性递送系统200、其变型或其另选的替代方案的示例性方法800,如本领域的普通技术人员将了解和理解的。
在方框802处,可将具有远侧带的植入物定位在引导导管内。远侧带和引导导管可以为如本文所示的远侧带124和引导导管310、其变型或其另选的替代方案,如本领域的普通技术人员将了解和理解的。在一些示例中,递送管也可定位在引导导管内,邻近所述植入物。递送管可以为如本文所述的递送管210、其变型或其另选的替代方案,如本领域的普通技术人员将了解和理解的。递送管、引导导管和植入物可如本文所述定位,如本领域的普通技术人员将了解和理解的以其它方式定位。除此之外或另选地,递送管还可为如本文所述的中空推杆320、其变型或其另选的替代方案,如本领域的普通技术人员将了解和理解的。在此类示例中,中空推杆可如本文所述定位在引导导管内、在植入物近侧,或以其它方式定位,如由本领域的普通技术人员将了解和理解的。
在方框804处,牵拉线和接合线延伸穿过环线的孔和近侧环的管腔。牵拉线、接合线、环线和近侧环可各自分别为如本文所述的牵拉线220、接合线230、环线218和近侧环122、其变型、或其另选的替代方案,如本领域的普通技术人员将了解和理解的。在一些示例中,在牵拉线220可延伸穿过环线218的孔218a之前,接合线230可延伸穿过环线218的孔218a。另选地,在牵拉线220可延伸穿过近侧环122的管腔126之前,接合线230可延伸穿过近侧环122的管腔126。在一些示例中,接合线230不需要延伸穿过环线218的孔218a。在一些示例中,牵拉线220不需要延伸穿过环线218的孔218a。在一些示例中,牵拉线220和接合线230均不延伸穿过环线218的孔218a,并且不需要存在脱离特征部123。牵拉线220和接合线230可延伸穿过编织物110的管腔125。在一些示例中,在牵拉线220可延伸穿过编织物110的管腔125之前,接合线230可延伸穿过编织物110的管腔125。牵拉线220和接合线230延伸穿过远侧带124的管腔128。在一些示例中,在牵拉线220可延伸穿过远侧带124的管腔128之前,接合线230可延伸穿过远侧带124的管腔128。具有穿过其中的牵拉线220和接合线230的植入物100可被定位在递送导管310内,使得接合特征部238可相对于远侧带124沿远侧方向定位。
在方框806处,植入物100可穿过动脉瘤10的颈部16,以通过使用中空推杆320或递送管210推动植入物100来进入动脉瘤的囊12。在一些示例中,中空推杆320的远侧端部可接合植入物100的近侧带122,从而允许中空推杆320将植入物100推入动脉瘤10的囊12中。在一些示例中,脱离特征部123可经由环线218固定到递送管210的凹口216,从而允许递送管210将植入物100推入动脉瘤10的囊12中。
在方框808处,植入物100可通过使接合线230沿近侧方向回缩而在囊12内再成形,同时牵拉线220保持延伸穿过远侧带124的管腔128。这导致远侧带124沿近侧方向移动,从而使编织物110再成形。
在方框810处,牵拉线220可沿近侧方向穿过远侧环124的管腔128、编织物110的管腔125和近侧带122的管腔126回缩。在一些示例中,牵拉线220可通过环线218的孔218a回缩。
在方框812处,接合线230可沿近侧方向穿过远侧带124的管腔128、编织物110的管腔125和近侧带122的管腔126回缩。在一些示例中,接合线230可通过环线218的孔218a回缩。
在方框814处,植入物100可经由递送管210的回缩与递送系统200脱离接合,从而导致环线218从脱离特征部123的开口123a脱落,并且因此允许脱离特征部123从递送管210的凹口216脱离。另选地,中空推杆320将植入物100推出引导导管310并推入囊12中,但不使用脱离特征部123或环线218。
图9示出用于使用递送系统部署植入物(诸如如本文所述的示例性植入物100和/或示例性递送系统200、其变型或其另选的替代方案)的示例性方法900,如本领域的普通技术人员将了解和理解的。
在方框902处,远侧环可沿接近管状编织物的远侧端部的中心轴线定位。远侧环和管状编织物可各自分别为如本文所述的远侧环124和管状编织物110、其变型或其另选的替代方案,如本领域的普通技术人员将了解和理解的。远侧环124可附接到管状编织物110的远侧端部114。
在方框904处,递送系统可包括接合线,该接合线包括接合特征部和细长构件,并且该接合特征部可定位在细长构件的远侧端部处。接合线可以为如本文所述的接合线230、其变型或其另选的替代方案,如本领域的普通技术人员将了解和理解的。接合特征部238可从细长构件236的远侧端部234径向延伸。接合特征部可通过研磨、焊接、胶合或其它方式形成,如本领域普通技术人员将了解和理解的。例如,聚合物套筒或金属套筒可附连到芯线的一部分,该芯线可形成接合线的细长构件,并且套筒可磨削成期望的形状以形成接合特征部。另选地,接合特征部可通过在芯线的端部上形成焊接珠来形成,该芯线形成接合线的细长构件。
在方框906处,可将近侧环定位在编织物的近侧端部处。近侧环可以为如本文所述的近侧环122、其变型或其另选的替代方案,如本领域的普通技术人员将了解和理解的。近侧环122可附接到管状编织物110的近侧端部112。在一些示例中,脱离特征部(诸如本文所述的脱离特征部123、其变型或其另选的替代方案)可附接到近侧环122。
在方框908处,牵拉线220和接合线230延伸穿过环线218的孔218a和近侧环122的管腔126。牵拉线和环线可各自分别为如本文所述的牵拉线220和环线218、其变型、或其另选的替代方案,如本领域的普通技术人员将了解和理解的。环线218可附连到递送管,诸如本文所述的递送管210、其变型、或其另选的替代方案,如本领域的普通技术人员将了解和理解的。环线218和/或牵拉线220延伸穿过环线218的孔218a可用于将植入物100可释放地固定到递送管210。在示例性系统中,在牵拉线220可延伸穿过环线218的孔218a之前,接合线230可延伸穿过环线218的孔218a。在另一示例性系统中,在牵拉线220可延伸穿过近侧环122的管腔126之前,接合线230可延伸穿过近侧环122的管腔126。在又一个示例性系统中,接合线230不需要延伸穿过环线218的孔218a。在另一示例性系统中,牵拉线220不需要延伸穿过环线218的孔218a。在又一个示例性系统中,牵拉线220和接合线230均不延伸穿过环线218的孔218a并且不需要存在脱离特征部123。
在方框910处,牵拉线220和接合线230延伸穿过管状编织物110的管腔125。在示例性系统中,在牵拉线220可延伸穿过管状编织物110的管腔125之前,接合线230可延伸穿过管状编织物110的管腔125。
在方框912处,牵拉线220和接合线230延伸穿过远侧环124的管腔128。在示例性系统中,在牵拉线220可延伸穿过远侧环124的管腔128之前,接合线230可延伸穿过远侧环124的管腔128。
在方框914处,可将具有穿过其的牵拉线220和接合线230的植入物100定位在递送导管310内,使得接合特征部238相对于远侧环124沿远侧方向定位。
在方框916处,植入物100可经由牵拉线220和接合线230从远侧环124的管腔128、管状编织物110的管腔125和近侧环122的管腔126的回缩而与递送系统200脱离接合。在示例性系统中,牵拉线220或接合线230中的至少一者可从环线218的孔218a回缩。
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,本发明设想植入物系统的多种变型和修改,包括本文所述的元件和部件的替代几何形状、替代编织形状,利用多种方式中的一种或多种以用于编织、针织、织造或以其它方式形成编织物,利用每个部件或元件的替代材料(例如,射线不可透材料、记忆形状材料、聚合物、金属等),利用附加部件来执行本文所描述或本文未描述的功能。这些修改对本领域中的普通技术人员将是显而易见的,并且旨在处于以下权利要求的范围内。
Claims (20)
1.一种系统,包括:
接合线,所述接合线包括细长构件和设置在所述细长构件的远侧端部处的接合特征部;
牵拉线;以及
植入物,所述植入物包括:
编织物,所述编织物能够从被定尺寸成横穿导管的递送形状移动成被定尺寸成闭塞动脉瘤颈部的植入形状;以及
远侧环,所述远侧环附连到所述编织物,
其中,当所述编织物处于所述递送形状时,所述牵拉线和所述细长构件延伸穿过所述远侧环,并且所述接合特征部相对于所述远侧环处于远侧方向,
其中所述牵拉线和所述细长构件能够沿近侧方向移动以使所述接合特征部接合到所述远侧环并且使所述远侧环朝近侧移动,并且
其中在所述远侧环朝近侧移动时,所述编织物能够从所述递送形状移动成所述植入形状。
2.根据权利要求1所述的系统,
其中所述植入物还包括附连到所述编织物的近侧环,
其中,当所述编织物处于所述递送形状时,所述牵拉线和所述细长构件延伸穿过所述近侧环,并且
其中,当所述编织物处于所述递送形状时,所述近侧环相对于所述远侧环处于所述近侧方向。
3. 根据权利要求2所述的系统,还包括:
递送管,所述递送管可拆卸地附接到所述植入物;以及
环线,所述环线附连到所述递送管,
其中所述植入物包括脱离特征部,所述脱离特征部包括穿过所述脱离特征部的开口,
其中所述环线延伸穿过所述脱离特征部中的所述开口,
其中所述牵拉线和所述细长构件中的一者或两者延伸穿过所述环线,并且
其中所述牵拉线能够移动以离开所述环线,
其中在所述牵拉线已离开所述环线之后,所述细长构件和所述接合特征部能够移动以离开所述环线,并且
其中当所述牵拉线和所述细长构件两者离开所述环线时,所述环线能够移动以离开所述开口。
4. 根据权利要求3所述的系统,
其中所述递送管包括接近所述递送管的远侧端部的凹口,并且
其中所述脱离特征部定位在所述凹口内。
5. 根据权利要求2所述的系统,还包括:
中空推杆,其中,所述中空推杆接合所述植入物的所述近侧环;并且
其中所述中空推杆包括内径,所述内径大于所述牵拉线的直径和所述细长构件的直径的总和。
6. 根据权利要求1所述的系统,其中所述接合特征部的直径小于所述远侧环的内径。
7.根据权利要求1所述的系统,其中所述远侧环的内径大于所述牵拉线的直径和所述细长构件的直径的总和;并且
其中所述远侧环的内径小于所述牵拉线的直径和所述接合特征部的直径的总和。
8.根据权利要求1所述的系统,其中所述接合特征部关于一个或多个轴线不对称。
9.一种用于构造植入物的方法,所述植入物包括远侧环和用于递送的管状编织物,所述方法包括:
将所述远侧环定位成接近所述管状编织物的远侧端部;
定位接合特征部以从细长构件的远侧端部径向延伸;
使所述细长构件延伸穿过所述管状编织物的管腔和所述远侧环的管腔;
使牵拉线延伸穿过所述管状编织物的所述管腔和所述远侧环的所述管腔,使得所述牵拉线阻止所述接合特征部穿过所述远侧环的所述管腔;
使所述接合特征部沿近侧方向回缩以将所述植入物固定在动脉瘤内;
使所述牵拉线沿近侧方向从所述植入物回缩;
使所述接合特征部沿近侧方向从所述植入物回缩,使得所述植入物与至少所述牵拉线和所述接合特征部脱离接合;以及
使所述植入物与递送管脱离接合。
10.根据权利要求9所述的方法,还包括:
将具有穿过其的所述细长构件和所述牵拉线的所述植入物定位在递送导管内,使得所述接合特征部相对于所述远侧环沿远侧方向定位。
11. 根据权利要求9所述的方法,还包括:
将近侧环附接到所述管状编织物的近侧端部;以及
使所述细长构件和所述牵拉线延伸穿过所述近侧环的管腔。
12. 根据权利要求11所述的方法,还包括:
将脱离特征部附接到所述近侧环;以及
将所述脱离特征部可拆卸地附接到递送管。
13.根据权利要求12所述的方法,还包括:
将所述脱离特征部定位在所述递送管的远侧端部处的凹口中。
14.根据权利要求12所述的方法,所述方法还包括:
将环线附接到所述递送管;
使所述环线延伸穿过所述脱离特征部的开口;以及
使至少所述牵拉线或细长构件延伸穿过所述环线的孔。
15.根据权利要求11所述的方法,还包括:
将中空推杆的远侧端部接合到所述近侧环,使得所述中空推杆被构造成在治疗期间脱离接合所述近侧环。
16.一种用于定位植入物的方法,所述方法包括:
将其上包括远侧环的所述植入物定位在递送导管内;
将牵拉线和其上具有接合特征部的细长构件定位成穿过所述远侧环的管腔,使得所述接合特征部相对于所述远侧环沿远侧方向定位,并且使得所述牵拉线阻止所述接合特征部穿过所述远侧环的所述管腔;
使所述植入物延伸穿过动脉瘤的颈部;
通过使所述细长构件在所述牵拉线延伸穿过所述远侧环时回缩,来使所述动脉瘤内的所述植入物再成形,从而导致所述接合特征部接合所述远侧环并使所述远侧环朝近侧移动;
使所述牵拉线沿近侧方向从所述植入物回缩;
使所述接合特征部沿近侧方向从所述植入物回缩,使得所述植入物与至少所述牵拉线和所述接合特征部脱离接合;以及
使所述植入物与递送管脱离接合。
17.根据权利要求16所述的方法,还包括:
将所述植入物固定在所述动脉瘤内。
18.根据权利要求16所述的方法,还包括:
将所述递送管接合到所述植入物;
将所述递送管、所述植入物、所述牵拉线和所述细长构件定位在所述递送导管内;以及
通过朝远侧推动所述递送管来使所述植入物朝远侧移动穿过所述递送导管。
19.根据权利要求18所述的方法,还包括:
通过首先使所述牵拉线从附接到所述递送管的环线中的开口回缩并且随后使所述细长构件从所述开口回缩从而使得所述环线脱离接合所述植入物,来使所述递送管与所述植入物脱离接合。
20.根据权利要求16所述的方法,还包括:
将所述递送管相对于近侧环沿近侧方向定位,所述近侧环被设置成接近所述植入物的近侧端部,其中所述递送管为中空推杆;
将所述牵拉线和所述细长构件定位在所述中空推杆的管腔内和所述近侧环的管腔内;
沿远侧方向抵靠所述近侧环推动所述中空推杆,从而使所述植入物朝远侧移动穿过所述递送导管;
将所述近侧环保持在所述递送导管内,同时使所述植入物延伸穿过所述动脉瘤的所述颈部,并且同时通过使所述细长构件在所述牵拉线延伸穿过所述远侧环时回缩来使所述植入物再成形;
使所述中空推杆接合到所述近侧环,同时通过使所述细长构件在所述牵拉线延伸穿过所述远侧环时回缩来使所述植入物再成形;
使所述牵拉线沿所述近侧方向从所述远侧环回缩以从所述远侧环的所述管腔移除所述牵拉线;
使所述接合特征部沿所述近侧方向穿过所述远侧环回缩,同时将所述牵拉线从所述远侧环移除;
使所述牵拉线沿所述近侧方向穿过所述近侧环回缩;
使所述接合特征部沿所述近侧方向穿过所述近侧环回缩;以及
使所述中空推杆沿所述近侧方向回缩,从而使所述中空推杆与所述近侧环脱离接合。
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-
2019
- 2019-11-18 US US16/686,361 patent/US11376013B2/en active Active
-
2020
- 2020-11-17 JP JP2020190716A patent/JP2021079104A/ja active Pending
- 2020-11-17 KR KR1020200153523A patent/KR20210060348A/ko unknown
- 2020-11-17 EP EP20208130.3A patent/EP3821825A1/en not_active Withdrawn
- 2020-11-18 CN CN202011296465.8A patent/CN112807046A/zh not_active Withdrawn
-
2022
- 2022-06-16 US US17/841,926 patent/US20220304699A1/en not_active Abandoned
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN114848073A (zh) * | 2022-05-26 | 2022-08-05 | 北京先瑞达医疗科技有限公司 | 一种体内植入物递送装置及输送系统 |
Also Published As
Publication number | Publication date |
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US20210145449A1 (en) | 2021-05-20 |
KR20210060348A (ko) | 2021-05-26 |
EP3821825A1 (en) | 2021-05-19 |
JP2021079104A (ja) | 2021-05-27 |
US20220304699A1 (en) | 2022-09-29 |
US11376013B2 (en) | 2022-07-05 |
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