CN102844071B - 用于神经脉管应用的低剖面引导导管 - Google Patents
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Abstract
本发明涉及具有非圆形形状的低剖面引导导管,所述低剖面引导导管用于递送处理神经脉管缺陷,例如处理动脉瘤的多个微导管。所述低剖面引导导管包括扭矩传递引导壁,所述扭矩传递引导壁为线性柔韧而非周向柔韧的,并且既不可收缩、也不可扭结。
Description
相关专利申请的交叉引用
本申请要求提交于2010年4月19日的临时专利申请No.61/325,784的优先权日的优先权,该专利全文清楚地以引用方式并入本文。
背景技术
本发明整体涉及用于下述装置的引导导管,所述装置用于治疗剂介入治疗或治疗脉管系统缺陷的脉管外科手术,更具体地讲涉及具有扭矩传递引导壁的引导导管,所述引导壁为线性柔韧而非周向柔韧的,并且既不可收缩、也不可扭结,该引导导管用于递送治疗神经脉管系统缺陷(例如治疗动脉瘤)的脉管内介入装置。
通常使用导管将诸如血管闭塞装置的脉管介入装置置入人体的脉管系统内。通常将血管闭塞装置置入血管内,以通过形成栓子来阻断通过血管的血流,或将其置入起源于血管的动脉瘤内,以形成动脉瘤内的栓子。用于这些手术的血管闭塞装置也可具有广泛的多种构型,并且已经使用以外部手术置入的夹子、可拆卸血管闭塞球囊和会产生栓子的血管闭塞装置(例如一个或多个血管闭塞线圈)来处理动脉瘤。此类血管闭塞装置的递送已经有代表性地通过多种方式实现,包括经由导管,其中装置被推杆推送穿过导管远端处的开口来部署装置。血管闭塞装置可被制造成使它们将以线性形状穿过导管的管腔并在部署到待处理区域(例如动脉瘤)之后呈现最初形成时的复杂形状。
将引导导管或递送导管系统插入远离待处理区域的动脉位点是脉管内治疗的第一步,并且是治疗神经脉管系统缺陷(例如治疗动脉瘤)的最重要步骤之一。由于穿刺位点通常距离待处理位点非常远,所以穿刺的尺寸通常是至关重要的。通常,引导导管具有圆形横截面的外部形状。希望提供一种引导导管或递送导管,所述导管的横截面形状将减小法国尺寸(French size)等效横截面并从而减小穿刺位点的尺寸,同时保持用于将多个微导管递送到处理位点的较大直径导管的优点。还希望提供一种引导导管或递送导管,所述导管的横截面形状可更容易地挠曲。本发明可满足这些以及其他需要。
发明内容
本发明提供具有非圆形外部横截面形状的低剖面引导导管,所述导管用于递送处理神经脉管缺陷,例如处理动脉瘤的多个微导管。本发明的低剖面引导导管包括扭矩传递引导壁,所述扭矩传递引导壁为线性柔韧而非周向柔韧的,并且既不可收缩、也不可扭结。
通过改变具有容纳多个微导管的管腔的引导导管或递送导管的横截面的形状,引导导管或递送导管可具有更小的横截面积,并且因此具有更小的穿刺尺寸。通过将导管的管腔的横截面形状从圆形变为椭圆形,可以在适合6Fr导引系统、但具有更小剖面的5Fr等效引导导管中容纳两个0.017英寸装置,从而将脉管创伤降至最低。外部导管轴结构可以由编织物和/或线圈构造与光滑的PTFE 内腔组成,以优化动脉最远侧部分中的线材交换过程。引导导管的近侧区域可具有符合人体工程学设计的毂,以允许医师容易地操纵导管并插入其他医疗装置。在一个目前优选的实施例中,引导导管包括分段的、逐渐适形的顶端设计,该设计整合了适形的聚合材料以将脉管创伤降至最低。导管的外部可被聚合材料覆盖,以将不锈钢和/或铂编织物和/或线圈构造包封起来。在当前优选的实施例中,此类聚合材料包括光滑的亲水性外涂层。
在本发明的多个当前优选的实施例之一中,所提供的用于神经脉管应用的低剖面引导导管具有细长的壁结构,该壁结构沿着导管的长度延伸并限定具有低剖面、非圆形横截面形状的至少一个管腔,所述管腔可沿着导管长度的至少一部分相对容易地挠曲。在本发明的一个目前优选的实施例中,低剖面导管还可具有沿着细长壁结构的至少一部分的引导壁,从而形成线性柔韧、周向相对不柔韧并且抗收缩和抗扭结的导管外部。
导管长度的一部分具有容易挠曲的低剖面、非圆形横截面形状,与具有圆形横截面形状的常规导管的长度的类似部分相比,其在至少一个维度上可更容易挠曲。在目前优选的实施例中,非圆形横截面形状可以是椭圆形、平行四边形或具有圆角的三角形。在本发明的另一个方面,细长壁结构可由金属或塑料编织物或线圈或它们的组合形成。在本发明的一个方面,细长壁结构仅限定一个管腔。限定最内层管腔的细长壁结构的一部分可以具有光滑的内表面,以优化动脉远侧部分内的线材交换过程。光滑内表面可通过细长壁结构上的涂层形成。光滑内表面可以由聚四氟乙烯(PTFE)形成或包含聚四氟乙烯(PTFE)。导管的远端可具有分段的、逐渐适形的远尖端设计,该设计中具有适形的聚合材料,以将脉管创伤降至最低。导管可具有含聚合材料的外表面,所述聚合材料具有光滑的亲水外涂层,以将编织物包封起来。导管可具有含聚合材料的外表面,所述聚合材料具有光滑的亲水外涂层,以将线圈包封起来。细长壁结构可限定最内层管腔,该管腔被构造成贴合其中的两个或更多个医疗装置。可提供至少两个微导管,并将其设置在低剖面引导导管的最内层管腔内,例如在具有椭圆形横截面形状的低剖面引导导管内。可提供至少三个微导管,并将其设置在低剖面引导导管的最内层管腔内,例如在具有圆角三角形横截面形状的低剖面引导导管内。可提供至少四个微导管,并将其设置在低剖面引导导管的最内层管腔内,例如在具有平行四边形横截面形状的低剖面引导导管内。
在本发明的多个优选实施例的另一个方面,所提供的用于神经脉管应用的低剖面引导导管具有细长壁结构,该壁结构沿着导管的长度延伸,所述壁结构限定具有低剖面、非圆形横截面形状的至少一个管腔,所述管腔易于沿着导管长度的至少一部分挠曲。根据本发明的引导导管优选地具有第一法国尺寸的远端和被构造成适合具有第二法国尺寸的医疗装置近端的近端,所述第二法国尺寸大于第一法国尺寸。细长壁结构可限定最内层管腔,该管腔被构造成贴合其中的两个或更多个医疗装置。也可提供至少两个微导管,并将其设置在低剖面引导导管(例如具有椭圆形横截面形状的引导导管)的最内层管腔内。
在本发明的多个方面的又一个方面,提供了在递送用于治疗神经脉管系统内缺陷的至少一个脉管内介入装置期间将创伤降至最低的方法。该方法涉及将根据上述方面的任一方面的低剖面引导导管插入神经脉管系统,并通过低剖面引导导管的细长壁结构限定的管腔递送脉管内介入装置。
根据以下的具体实施方式和附图,本发明的这些和其他优点将变得更清楚,附图以实例的方式示出本发明的特征。
附图说明
图1是具有两个微导管的现有技术圆形引导导管的前视图。
图2是图1的圆形引导导管的等轴视图。
图3是根据本发明的实施例的具有两个微导管的低剖面引导导管的前视图,其中非圆形横截面形状是平面的或基本上椭圆形的。
图4是根据本发明的实施例的具有两个微导管的低剖面引导导管的等轴视图,其中非圆形横截面形状是平面的或基本上椭圆形的。
图5是根据本发明的一个实施例的具有两个微导管的平面引导导管的横截面示意图。
图6是根据本发明的另一个实施例的具有两个微导管的平面引导导管的透视图,其中引导导管的远尖端具有分段的逐渐适形的顶端设计。
具体实施方式
参见以举例而非限制性方式提供的附图,本发明提供具有非圆形形状的低剖面引导导管10,该导管用于递送治疗神经脉管缺陷,例如治疗动脉瘤的多个微导管12a、12b。本发明的低剖面引导导管包括扭矩传递引导壁14a、14b,所述扭矩传递引导壁为线性柔韧而非周向柔韧的,并且既不可收缩、也不可扭结。通过改变导管管腔16的横截面形状,可将更多的标准装置容纳到更小的导管中。
例如,为了将两个具有0.017英寸内径管腔的微导管递送到大脑脉管系统中,医师通常选择具有6Fr或等效0.070英寸内径管腔的引导导管。采用我们的发明,通过将导管管腔的外部横截面形状从圆形改变为椭圆形,可使两个0.017英寸装置容纳到5Fr等效引导导管内,该导管仍然适合6Fr导引系统,但具有更小的剖面,从而将脉管创伤降至最低。在当前优选的实施例中,导管的外部横截面是椭圆形形状。低剖面引导导管的具体弯矩或最小挠曲力的平面可取决于横截面形状。例如,具有椭圆形横截面形状的低剖面引导导管将具有的弯矩取决于在给定外壁厚度下长轴和短轴的比率。这样,低剖面引导导管的具体弯矩可通过改变导管横截面的尺寸来按要求进行控制和更改。
在一个优选的实施例中,导管轴优选地由不锈的和/或铂编织物18和/或线圈19构造与光滑的PTFE 内腔涂层20的组合构成,以优化动脉最远侧部分中的线材交换过程。近侧区域(未示出)将具有符合人体工程学设计的毂,以允许医师容易地操纵导管并插入其他医疗装置。如图6所示,分段的逐渐适形的顶端设计24掺入了适形的聚合材料,以将脉管创伤降至最低。例如,根据一个实施例,分段的逐渐适形的顶端设计24可包括不同材料的各种区段26、28、30、32、34,和/或这些区段可为阶梯状的,使得分段的逐渐适形的远尖端24的刚度因区段而异。导管22的外部优选地覆盖有聚合材料以包封不锈的和/或铂编织物18和/或线圈19构造。在优选的实施例中,此类聚合材料将具有光滑的亲水性外涂层。
根据上述内容显而易见,虽然已经图示并描述了本发明的特定形式,但是可在不背离本发明的精神和范围的情况下进行多种修改。因此,本发明除了受所附权利要求书限制以外,不受其他限制。
Claims (14)
1.一种用于神经脉管应用的低剖面引导导管,包括:
沿着所述导管的长度延伸的细长壁结构,所述细长壁结构限定至少一个具有低剖面、非圆形横截面形状的管腔,所述管腔易于沿着所述导管的所述长度的至少一部分挠曲;以及
沿着所述细长壁结构的至少一部分的引导壁,所述引导壁是线性柔韧、周向相对不柔韧的,并且抗收缩和抗扭结,其中所述细长壁结构在所述引导壁中进一步地由编织物材料和线圈构成;
其中,所述导管使得能够在适合6Fr导引系统、但具有更小剖面的5Fr等效引导导管中容纳两个0.017英寸装置。
2.根据权利要求1所述的低剖面引导导管,其中所述非圆形横截面形状为椭圆形。
3.根据权利要求1所述的低剖面引导导管,其中所述线圈包括细长线圈,所述线圈的轴与所述细长壁结构的纵向轴线平行。
4.根据权利要求1所述的低剖面引导导管,其中限定最内层管腔的所述细长壁结构的一部分具有光滑的内表面,以优化动脉远侧部分中的线材交换过程。
5.根据权利要求4所述的低剖面引导导管,其中所述细长壁结构限定一个管腔。
6.根据权利要求4所述的低剖面引导导管,其中所述光滑内表面由所述细长壁结构上的涂层形成。
7.根据权利要求6所述的低剖面引导导管,其中所述光滑内表面由聚四氟乙烯形成。
8.根据权利要求1所述的低剖面引导导管,其中所述导管的远端具有分段的逐渐适形的远尖端设计,所述设计其中包含被选择用于将脉管创伤降至最低的适形的聚合材料。
9.根据权利要求1所述的低剖面引导导管,其中所述导管的外表面包含聚合材料,所述聚合材料具有光滑的亲水性外涂层以包封所述编织物材料。
10.根据权利要求1所述的低剖面引导导管,其中所述导管的外表面包含聚合材料,所述聚合材料具有光滑的亲水性外涂层以包封所述线圈。
11.根据权利要求1所述的低剖面引导导管,其中所述细长壁结构限定被构造成在其中容纳多个医疗装置的最内层管腔。
12.一种用于神经脉管应用的低剖面引导导管,包括:
沿着所述导管的长度延伸的细长外壁结构,所述细长外壁结构限定具有低剖面、非圆形横截面形状的至少一个管腔,所述管腔沿着所述导管的所述长度的至少一部分相对容易地挠曲,所述引导导管具有第一法国尺寸的远端和被构造成适合医疗装置近端的近端,所述医疗装置的所述近端的第二法国尺寸大于所述第一法国尺寸,其中所述细长外壁结构在沿着所述细长外壁结构的至少一部分的引导壁中进一步地由编织物材料和线圈构成;
其中,所述导管使得能够在适合6Fr导引系统、但具有更小剖面的5Fr等效引导导管中容纳两个0.017英寸装置。
13.根据权利要求12所述的低剖面引导导管,其中所述细长壁结构的内壁限定被构造成贴合其中的两个或更多个医疗递送微导管的内腔。
14.根据权利要求13所述的低剖面引导导管,还包括设置在所述低剖面引导导管的最内层管腔内的至少两个微导管。
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PCT/US2011/032945 WO2011133486A1 (en) | 2010-04-19 | 2011-04-19 | Low profile guiding catheter for neurovascular applications |
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CN102844071B true CN102844071B (zh) | 2017-05-17 |
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CN (1) | CN102844071B (zh) |
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US20120041411A1 (en) | 2012-02-16 |
AU2011242906A1 (en) | 2012-11-08 |
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JP2013524943A (ja) | 2013-06-20 |
CA2796951C (en) | 2018-08-21 |
EP2560721B1 (en) | 2020-08-19 |
EP2560721A1 (en) | 2013-02-27 |
KR20130095185A (ko) | 2013-08-27 |
ES2820456T3 (es) | 2021-04-21 |
BR112012026900A2 (pt) | 2017-10-10 |
CN102844071A (zh) | 2012-12-26 |
KR101903973B1 (ko) | 2018-10-05 |
JP6000941B2 (ja) | 2016-10-05 |
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AU2011242906B2 (en) | 2016-04-21 |
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