CN111110984B - 具有经修改ptfe衬里的微导管 - Google Patents
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Abstract
一种具有增强内衬里的微导管,所述内衬里具有低摩擦力和改善韧性,从而促进可膨胀血管重构器械的递送。
Description
本分案申请是基于申请号为201480040200.8,申请日为2014年07月10日,发明名称为“具有经修改PTFE衬里的微导管”的中国专利申请的分案申请。该中国专利申请为国际申请号为PCT/US2014/046234的国际申请的中国国家阶段。
技术领域
下文描述的器械和方法涉及动脉瘤和血液凝块治疗的领域。
背景技术
颅内动脉瘤和血液凝块可利用可植入器械如分流管、栓塞器械、动脉瘤架桥器械和支架器械和血栓切除器械进行治疗。这些器械通过微导管递送,首先将微导管递送至受动脉瘤或凝块影响的颅内动脉中。以前,这些器械会被预加载至用于导入患者的微导管的尖端上。较新的器械不进行预加载,而是在放置微导管,使其远尖端深入颅内静脉,接近动脉瘤或血液凝块的部位后经由微导管的近端毂加载。通过微导管递送的自膨胀器械的实例包括神经血管重塑器械如Covidien的栓塞器械(其是经放置以跨越并绕过动脉瘤的编织管)和Covidien的血栓切除器械,其用于从颅内动脉取出血液凝块,和我们自有的动脉瘤架桥器械,其用作支架以支持动脉瘤内的栓塞材料。这些器械以压缩状态通过微导管,并从微导管释放以膨胀至远远更大的直径。压缩形状施加向外的径向力,其导致与微导管内壁的摩擦并造成递送困难。当迫使器械通过微导管时,其可刮伤微导管的内壁并刨下衬里小碎片,这些碎片随后可受微导管驱使并沉积在脑中。FDA的MAUDE不良事件报告数据库包括关于用于递送可膨胀器械的各种导管衬里损伤、过度摩擦和刮削的报告。
发明内容
下文描述的器械和方法提供通过改良的微导管更容易地将可膨胀血管重构器械(如分流管、栓塞器械、动脉瘤架桥器械、支架器械和血栓切除器械)递送至患者血管系统中的方式。所述改良的微导管使用具有比常见PTFE或ePTFE衬里低的摩擦系数和增大的韧性的衬里构成。低摩擦系数减小微导管与穿过微导管的可膨胀器械之间的递送摩擦力,且减小可能沉积至血管系统中的衬里材料刮削。
微导管之所以得到增强是因为微导管包括拉伸的PTFE(聚四氟乙烯)衬里。在微导管长度的至少一部分上,PTFE衬里(或衬里部分)只沿纵向且不会圆周或径向拉伸。增强的衬里导致递送摩擦力减小和刮擦韧性及耐性改善。优选地,所述微导管包括层状构造,其包括布置在衬里上的线圈和在线圈上再流的护套。或者微导管可包括其它层或可仅由拉伸的PTFE衬里组成而不存在其它层,且层数可沿微导管的长度变化
微导管可用于递送动脉瘤治疗器械、栓塞器械、神经血管重塑器械和血栓切除器械,这些器械经由微导管的近端毂加载且随后航行微导管的整个长度,然后部署在颈动脉内的所需目标部位。
附图说明
图1是大脑血管系统的示意图,其示出具有增强PTFE衬里的动脉瘤治疗微导管的放置。
图2图示推进微导管和治疗器械穿过患者的路径。
图3、图4和图5图示增强的微导管。
图6和图7图示位移相对递送导管与图3、图4和图5微导管之间的摩擦的比较关系。
具体实施方式
图1是大脑血管系统的示意图,其示出可膨胀血管重构器械1的放置。示出动脉瘤治疗器械在脑底动脉环(the Circle of Willis)内的例示放置。动脉瘤治疗器械经由增强微导管3递送至这个血管缺陷部位2。作为动脉瘤治疗器械的预期使用环境的神经血管通过颈各侧上的颈动脉和椎动脉给大脑4供血。重要动脉,颈中的颈动脉5和给眼动脉7供血的颈内动脉6。颈外动脉8给上颌动脉9、脑膜中动脉10-和颞浅动脉11(额)和12(顶叶)供血。椎动脉13给基底动脉14和脑动脉(包括脑后动脉15和大体上在16所指示的脑底动脉环)供血。椎动脉的虹吸管位于脊椎上的颅内血管系统中,靠近脑底动脉环。颈内动脉还给脑前动脉17和脑中动脉18以及脑底动脉环(包括后交通动脉19和前交通动脉20)供血。颈内动脉6的虹吸管位于颈动脉上的颅内血管系统中,靠近脑底动脉环。这些动脉一般具有约1mm至5mm,最常见2至4mm的内径。本文描述的方法和器械允许访问这些动脉并将动脉瘤治疗器械放置于这些动脉内。例如,如图1所示,微导管已被用于递送可膨胀血管重构器械1以分离位于眼动脉高位,在脑底动脉环以外的动脉瘤2。
图2图示推进微导管穿过患者的路径。微导管3通过股动脉21导入,并航行通过主动脉22且被推进至患者的颅内血管系统23中。最终目标部位可以在颈动脉、基底动脉中,或在脑底动脉环内或以外,或在脑血管系统的其它地方。为了递送可膨胀血管重构器械,将器械固定于递送线,插入微导管3的近端,并推动通过微导管的整个长度。在颈总动脉的近部以外的脑血管系统内,使微导管穿过急扭和急转。可膨胀血管重构器械被推动通过这些急扭和急转,并遇到来自微导管内壁的显著摩擦力和阻力。下文描述的微导管构造减小了这种摩擦力和阻力。
图3、图4和图5图示微导管。图3图示微导管的远段。微导管由三个层组成。微导管的最内层包括拉伸PTFE衬里或管30。PTFE衬里沿纵向拉伸,而不会径向或圆周拉伸。第二层包括布置在拉伸PTFE衬里或管的至少一部分上的线圈31。第三或最外层包括布置在线圈上的护套32。合适PTFE材料包括在商标名下出售的PTFE且具体包括Zeus SUB-LITE-PTFE管线,且可包括膨胀PTFE和热收缩PTFE配制物。线圈是优选镍钛诺,或任何其它合适伪弹性线圈。线圈围绕拉伸PTFE衬里单卷绕。单螺旋线圈优选按照使线圈的相邻匝之间具有介于0.0254mm至0.1524mm之间的间隙进行卷绕。具体来说,最远22cm以0.1524mm间隙盘绕。邻接最远22cm的4cm以0.1016mm间隙卷绕。邻接上述4cm段的1cm以0.0254mm间隙卷绕。所有这些尺寸均为近似值,且属于优选实施方案,且可变化以获得更大或更小的远段可挠性、可扭转性和可推动性。最外层由加载在镍钛诺线圈上的各类聚醚酰胺(pebax)(聚醚嵌段酰胺或PEBA)形成。在远段,最远1cm由具有25D硬度的聚醚酰胺覆盖。邻接最远1cm的14cm由具有35D硬度的聚醚酰胺覆盖。邻接上述14cm的5cm由具有40D硬度的聚醚酰胺覆盖。邻接上述5cm的下一个5cm由具有55D硬度的聚醚酰胺覆盖。邻接上述5cm的下一个27cm(跨越导管的远段和近段)由具有72D硬度的聚醚酰胺覆盖。所有这些硬度规格均为近似值,且属于优选实施方案,且可变化以获得更大或更小的远段可挠性、可扭转性和可推动性。
图4图示微导管近段的层。微导管的这个近部也大体上由三个层组成,其可以是远段相应层的延续。最内层包括拉伸PTFE衬里30(即,远段PTFE衬里的延续)。第二层包括布置在拉伸PTFE衬里近端130cm上的一对交叉卷绕镍钛诺线圈33。交叉卷绕线圈优选以0.254mm间隙卷绕。第三或最外层包括布置在交叉卷绕镍钛诺线圈上的护套34或管。(可将其它伪弹性或弹性材料用于交叉卷绕线圈,或可使用镍钛诺或其它伪弹性或弹性材料的辫子代替交叉卷绕线圈)。最外层由加载在交叉卷绕镍钛诺线圈上的各种尼龙和聚醚酰胺材料形成。具体来说,72D聚醚酰胺布置在邻接(紧靠)图3所示远段的上述40D聚醚酰胺12cm的27cm上。而且,尼龙(Grilamid L25)布置在邻接上的72D聚醚酰胺27cm的105cm段上。
图5图示微导管的外层,其经涂覆并含有在微导管的近端的毂。微导管毂中的鲁尔接头被用于附接附属件。微导管的整个长度为约157cm,包括远段(在这个实例中为27cm长)和近段(在这个实例中为130cm长)。
为了形成微导管,加热PTFE衬里并沿纵向拉伸,而不圆周或径向拉伸。随后用具有可变间隙的单层镍钛诺线圈卷绕衬里的远段(如图3所示)并用一对交叉卷绕镍钛诺线圈卷绕衬里的余下近部以形成微导管的第二层(如图4所示)。随后使各类聚醚酰胺和尼龙在微导管的第二层上滑动。使热收缩管层在聚醚酰胺材料上滑动并逐段加热以使聚醚酰胺收缩并再流。随后移除热收缩管。
虽然可使用许多方法拉伸PTFE衬里并组装微导管,但可使用以下方法。为了纵向拉伸PTFE衬里,同时避免圆周或径向拉伸,拉出具有合适内径、外径和长度的PTFE管并加热以拉伸所述管并在具有对应于所需衬里内径的直径的线上缩减内径。因此,镍钛诺线(被PTFE管覆盖,称为串珠)穿过PTFE管,且线和管垂直保持在一起,用夹钳悬挂,并将砝码固定于PTFE管以对管施加拉力,并加热PTFE管。加热所述管并拉紧直至拉伸25至100%,以使其拉伸长度比其原始长度长25至100百分比(还缩减内壁直径至其原始壁厚的约25至50%)。例如,对于0.021"(.53mm)内径、0.00075"(0.02mm)壁厚和70英寸(178cm)长的PTFE衬里,可在一端用夹具悬挂0.027"(.69mm)内径、0.001-.0015"(0.0254至0.0381mm)壁厚和52英寸(132cm)初始长度的PTFE管,且可将总共约115克的砝码固定于另一端,且可用热风枪加热PTFE管以获得具有0.021"直径和70英寸(178cm)拉伸长度及缩减至0.00075"(0.02mm)的内壁直径的PTFE衬里。因此,这个实例中的PTFE管沿纵向维度拉伸了约40%。在这个实例中,管的内径响应纵向拉伸从0.027"缩减至0.021"(或其原始直径的约20至25%),虽然在这个实施方案中有利,但不必实现这种缩减便可获得拉伸衬里的利益。在这个实例中,使用热风枪软化PTFE管。热风枪可在PTFE管上以恒定速度拖动,或可在PTFE管的不同纵向区域上以不同速度拖动,以建立不同程度拉伸,例如比近端区域更多地拉伸远端区域(这将获得具有较薄壁体的更具挠性远端区域)。PTFE衬里可由PTFE热收缩管形成,且可通过加热PTFE热收缩管使管圆周收缩,同时纵向拉紧所述管以纵向拉伸所述管的方式进行加工。还可以任何合适方式有区别地加热PTFE热收缩管的近段和远段。可通过烘箱或其它技术加热PTFE管。在使PTFE管向线缩减时,可将覆盖远段的线圈卷绕在远段上,且将覆盖近段的交叉卷绕线圈卷绕在近段上(随后将近段交叉线圈与远段线圈在其接合处焊接在一起)。通过使具有合适组成和硬度的聚醚酰胺管和尼龙管在远段线圈和近段交叉卷绕线圈上滑动,并用热收缩管线覆盖外护套,并加热这个总成以使聚醚酰胺和尼龙管线再流并将其压缩至远段线圈和近段交叉卷绕线圈中的方式施加外护套。将用于压缩外护套材料并使其再流的热收缩管线从三层微导管主体移除并丢弃,且将镍钛诺线从拉伸PTFE衬里移除,并对三层式微导管主体进行修整(如果需要,在远端和近端)并固定于近端毂或鲁尔接头。可将不透射线的标记物施加于外护套上,或包埋或夹在微导管的层之间,以在体内使用期间进行荧光观察时增强导管的视觉化。
在使用时,将引导导管经由患者腹股沟的小切口导入股动脉中。引导导管从股动脉21航行通过主动脉22并推进至颈动脉23中。最终目标部位可以在颅内血管系统深处,可能在脑底动脉环内或甚至更深处。引导增强微导管通过引导导管并递送至颅内血管系统中的目标位置。随后推动可膨胀血管重构器械穿过微导管到达颅内血管系统内的目标部位。
上文已按三层式构造描述微导管。微导管可由三个层组成,不存在其他层,且这种布局大大促进了器械递送,因为衬里相对于未拉伸PTFE管更润滑。而且,拉伸衬里的优点可在只包括增强衬里的微导管中实现。具体来说,仅由如上文所公开的拉伸PTFE衬里组成而不存在布置在PTFE衬里上的其它层的微导管或微导管远段。拉伸衬里可跨越微导管的整个长度或可仅在微导管的一部分上拉伸,如对器械通行的阻力最大的远段。
图6图示位移(经微导管移动的距离)相对于推动Covedien机械血栓切除器械通过Covidien 微导管相比于具有如上所述的拉伸PTFE衬里的微导管所需的力(克)的关系。推动器械从股动脉导入点通过跨越主动脉的微管部分所需的力保持几乎恒定,刚好在70克以下,如图线35所示。然而,推动器械通过微导管的最后20至30cm(认为是高度曲折区)所需的力大大增加。这个高度曲折区包括将器械从颈动脉推进至脑底动脉环内的区。图线36描绘推动相同Covedien 机械血栓切除器械通过如上所述微导管所需的力。推动器械从股动脉导入点通过跨越主动脉的微导管部分所需的力恒定,但小于50克,其比途经微导管所需的力要小得多。在颈动脉以外的高度曲折区中途经增强微导管的最后20至30cm所需的力显著小于在Rebar微导管内途经相应区所需的力。比较发现,当与Covidien 微导管相比时,增强的微导管衬里导致15%至30%递送摩擦力下降。这促进了递送,且降低衬里材料被通过器械刮削的风险。
以上器械一般施加超过0.075牛顿/毫米长度的向外径向力。衬里,且尤其是衬里的内表面经过修改以减小衬里与推动通过导管的器械之间的摩擦力,以使当导管的远端区域位于脑底动脉环内时推动器械通过微导管所需的纵向力小于380克。
图7图示位移(经微导管移动的距离)相对于推动Covidien栓塞器械(用于动脉瘤治疗)通过Covidien MarksmanTM微导管相比于具有如上所述拉伸PTFE衬里的微导管所需的力(克)的关系。这个图示出途经微导管的最后40至50cm所需的力。图线37描绘推动器械通过MarksmanTM微导管所需的力,而图线38描绘推动器械通过增强微导管所需的力。在曲折区域(导管的远端40或50cm,在使用时居于脑血管系统的曲折深入区域),增强微导管再次比MarksmanTM微导管呈现显著更小的器械通过阻力。
总体而言,相比于未拉伸衬里,拉伸衬里导致微导管摩擦力和推动器械通过微导管曲折区域所需的力下降40%,且管内表面的径向摩擦系数减小20%。如本文所使用的摩擦系数是指通过专门针对可膨胀血管重构器械和微导管的测试界定的系数。这个测试需要确定当压缩以匹配微导管内径时可膨胀血管重构器械的向外径向力(以牛顿计),并测定拉动可膨胀血管重构器械通过微导管(同时与衬里接触)所需的力(以牛顿计)。本文将径向摩擦系数定义为器械所施加的径向力对拉动器械通过微导管所需的力的比。在这个测试下,在可膨胀血管重构器械与PTFE衬里内表面之间测得的径向摩擦系数在约.07至.25的范围内。我们将这个摩擦系数称为“径向”摩擦系数以将其与在ASTM D1894下获得的PTFE的摩擦系数区分,PTFE的摩擦系数一般为0.02至0.1。
修改的衬里比原PTFE管更坚固且更坚韧。通过上述拉伸过程获得的PTFE衬里具有超过100Kpsi,一般约117Kpsi的杨氏模量,其远高于普通PTFE管线的常见杨氏模量(71Kpsi)。PTFE衬里还具有大大增加的拉伸强度,相比于未修改PTFE管增加了50至100%,使得拉伸强度从约18kpsi增大至超过20kpsi,一般为约28kpsi。
虽然已参考开发时所在的环境描述了器械和方法的优选实施方案,但它们仅仅用于说明本发明的目的。可将各实施方案的元素合并至各个其它物种以获得那些元素组合这些其它物种的利益,且各个有利特征可单独或相互组合地用于实施方案中。在不脱离本发明精神和随附权利要求的范围下可构想出其它实施方案和配置。
Claims (18)
1.一种制造导管的方法,所述导管包括形成所述导管的最内层的PTFE衬里、布置于所述PTFE衬里上的线圈、和布置于所述线圈上的护套,所述方法包括:
将PTFE管的具有初始长度的一部分纵向拉伸更长长度以建立所述PTFE衬里,所述更长长度为所述一部分的初始长度的25%至100%,其中,所述纵向拉伸的PTFE衬里表征为拉伸强度大于20kpsi;其中,所述导管构造成部署可膨胀器械,并且其中所述纵向拉伸过的PTFE衬里的内表面相对于所述可膨胀器械具有0.07到0.25的径向摩擦系数,所述径向摩擦系数是当所述可膨胀器械定位在所述导管内时所述可膨胀器械施加在所述纵向拉伸过的PTFE衬里上的径向力对拉动所述可膨胀器械通过所述纵向拉伸过的PTFE衬里所需的力的比;
将所述线圈缠绕在所述PTFE衬里的远段上;
将护套布置于所述线圈上。
2.根据权利要求1所述的方法,其中拉伸所述PTFE管的所述一部分以建立所述PTFE衬里包括:
拉紧所述PTFE管以将所述PTFE管的至少一部分延长所述一部分的初始长度的25%至100%。
3.根据权利要求1所述的方法,其中拉伸所述PTFE管的所述一部分以建立所述PTFE衬里包括:
拉紧所述PTFE管同时加热所述PTFE管,以将所述PTFE管的至少一部分延长所述一部分的初始长度的25%至100%。
4.根据权利要求3所述的方法,其中所述PTFE管以初始内径表征,且拉伸所述PTFE管以建立所述PTFE衬里包括:
将所述PTFE衬里的所述初始内径按初始内径缩减20%至25%。
5.根据权利要求1所述的方法,其中拉伸所述PTFE管的所述一部分以建立所述PTFE衬里包括:
加热所述PTFE管同时拉紧所述PTFE管以延长所述PTFE管的至少一部分。
6.根据权利要求1所述的方法,其中拉伸所述PTFE管的所述一部分以建立所述PTFE衬里包括:
以不同的速度将热量施加到所述PTFE管的不同纵向区域上同时拉紧所述PTFE管,以建立不同程度的拉伸。
7.根据权利要求1所述的方法,其中拉伸所述PTFE管的所述一部分以建立所述PTFE衬里包括:
通过垂直悬挂所述PTFE管来拉紧所述PTFE管,将砝码附接至所述PTFE管,并加热所述PTFE管以延长所述PTFE管的至少一部分。
8.根据权利要求1所述的方法,其中拉伸所述PTFE管以建立所述PTFE衬里包括:
通过垂直悬挂所述PTFE管来拉紧所述PTFE管,将砝码附接至所述PTFE管,并加热所述PTFE管以将所述PTFE管的至少一部分延长所述PTFE管的初始长度的10%至30%。
9.根据权利要求1所述的方法,其还包括:
将一线圈缠绕在所述PTFE衬里的近段上。
10.根据权利要求1所述的方法,其还包括:
将近端交叉卷绕线圈布置于所述PTFE衬里的近段上。
11.根据权利要求1所述的方法,其中所述PTFE管以初始内径表征,且拉伸所述PTFE管以建立所述PTFE衬里包括:
将所述PTFE衬里的所述初始内径按初始内径缩减20%至25%。
12.根据权利要求1所述的方法,其中所述纵向拉伸过的PTFE衬里具有约28kpsi的拉伸强度。
13.根据权利要求1所述的方法,其中所述导管的一部分仅具有所述纵向拉伸过的PTFE衬里。
14.根据权利要求1所述的方法,其中所述纵向拉伸过的PTFE衬里跨越所述导管的整个长度。
15.根据权利要求1所述的方法,其中所述纵向拉伸过的PTFE衬里仅跨越所述导管的一部分长度。
16.根据权利要求1所述的方法,还包括将可膨胀器械定位在所述纵向拉伸过的PTFE衬里内,其中所述可膨胀器械在所述纵向拉伸过的PTFE衬里上施加径向力。
17.根据权利要求1所述的方法,所述导管还包括在所述导管的近端区域中布置在PTFE衬里上的近端的交叉卷绕线圈。
18.根据权利要求17所述的方法,还包括将交叉卷绕线圈缠绕在所述PTFE衬里的近段上。
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- 2014-07-10 CN CN201480040200.8A patent/CN105705190B/zh active Active
- 2014-07-10 EP EP20203041.7A patent/EP3789070A1/en active Pending
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US20150025562A1 (en) | 2015-01-22 |
US10953193B2 (en) | 2021-03-23 |
JP2016528966A (ja) | 2016-09-23 |
CN105705190A (zh) | 2016-06-22 |
EP3021924A1 (en) | 2016-05-25 |
CA2918490A1 (en) | 2015-01-22 |
CN105705190B (zh) | 2019-12-17 |
US20200353206A1 (en) | 2020-11-12 |
CN111110984A (zh) | 2020-05-08 |
JP6316953B2 (ja) | 2018-04-25 |
AU2014290621A1 (en) | 2016-02-18 |
EP3021924B1 (en) | 2019-03-13 |
WO2015009548A1 (en) | 2015-01-22 |
EP3021924A4 (en) | 2016-08-10 |
EP3511045A1 (en) | 2019-07-17 |
CA2918490C (en) | 2019-03-19 |
EP3789070A1 (en) | 2021-03-10 |
AU2014290621B2 (en) | 2017-10-19 |
EP3511045B1 (en) | 2020-11-18 |
US11925766B2 (en) | 2024-03-12 |
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