CN1642593A - 在损伤处形成纵向通道的气囊导管及其制造法 - Google Patents
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Abstract
一种在血管内的损伤处完成血管成形术操作的气囊导管(21),包含具有近端和远端的柔性长导管筒(22)气囊(46)固定于所述导管筒的远端并有在气囊的近端(47)和远端(48)之间延伸的外表面(54)。设延伸过所述气囊外表面的柔性细长元件(61)。所述柔性细长元件有近端和远端(62)、(63),所述近端和远端固定于所述导管筒的周围,其位置在纵向上与所述气囊的外表面隔开以使所述气囊能膨胀并使所述柔性细长元件移动到与损伤处接触,以在所述损伤内形成纵向通道。
Description
技术领域
本发明涉及在损伤处形成纵向通道的气囊导管及制造这种气囊导管的方法。
背景技术
现有的气囊导管如美国专利5,196,024号、5,320,634号、5,616,149号和5,797,935号所披露的那样要在气囊上安装刀子。业已发现这种装置有缺点,因为必须有把刀子固定于气囊上的专用座。这种刀子有可能要从气囊上卸下。在其它实施例里,刀子安装在气囊的纵向槽内。这些解决办法降低了气囊的柔性并增加了制造成本。因此需要有能克服这些缺点的新的改进的气囊导管。
发明内容
一般地说,本发明的目的是提供一种在损伤处形成纵向通道的气囊导管及制造这种气囊导管的方法。
本发明的另一目的是提供一种具有上述特征的气囊导管及其制造法,其中使用多个柔性细长元件,用气囊径向推动之,以便在损伤处形成纵向通道。
本发明的再一目的是提供一种具有上述特征的气囊导管,有助于在充气时防止气囊纵向移动。
本发明的又一目的是提供一种具有上述特征的气囊导管及其制造方法,其中易于配置所述柔性细长元件。
本发明还有一个目的是提供一种具有上述特征的气囊导管,其中的柔性细长元件具有柔性便于穿过弯曲的血管。
本发明的另一目的是提供一种制造起来经济且具有上述特征的气囊导管。
附图说明
参照附图阅读下面对优选实施例的详细说明就会了解本发明的其它目的和特点。
图1是体现本发明的气囊导管的侧视图。
图2是沿图1的2-2线剖开的放大剖面图。
图3是沿图1的3-3线剖开的放大剖面图。
图4和图5是沿图1的5-5线剖开的剖面图,图4示出的是翼或折叶折叠前的气囊,图5示出的是气囊折叠后盖于所述柔性细长元件上,从而所述柔性细长元件在放入血管时不会损伤血管。
图6是图1内所示的气囊导管末端的放大图,显示气囊充气后的状况。
图7是沿图6的7-7线剖开的剖面图。
图8示出的是用于根据本发明气囊导管的另一个柔性细长元件的放大延长部分。
图9是沿图8的9-9线剖开的放大剖面图。
图10是沿图8的10-10线剖开的放大剖面图。
图11是结合图8、9和10所示的柔性细长元件的气囊导管的放大横断面图。
图12示出的是体现本发明气囊导管的另一实施例,其中柔性细长元件的近端和远端具有柔性。
图13是用于与本发明气囊导管连接的包含多个柔性细长元件的护架的轴侧图。
图14是图13内护架安装于气囊导管的未充气气囊上的轴侧图。
图15是所述护架在气囊膨胀后状态的放大轴侧图。
具体实施方式
一般地说,气囊导管是为了在血管内的损伤处完成血管成形术的。气囊导管包括有近端和远端的柔性细长导管筒。气囊固定于所述导管筒的远端,气囊本身有近端和远端,有内衬,并可以在泄气状态与充气状态之间转变。所述导管筒有气囊充气腔,所述充气腔从所述导管筒的近端延伸到其远端并开口进入气囊内部。设有一接头向所述充气腔供应充气介质使气囊从泄气状态变到充气状态。气囊有外表面,从其近端延展到远端,所述外表面在气囊充气时径向向外移。柔性细长元件在气囊的外表面上从气囊的近端延伸到气囊的远端。所述柔性细长元件有近端和远端,所述两端固定于所述导管筒的周围,与气囊的外表面分离,使气囊能膨胀,从而使柔性细长元件移动而与损伤处接合在损伤处形成纵向通道。
如图1-7更详细示出的,本发明的气囊导管21包括导管筒22,所述导管筒有近端和远端。所述导管筒22一般使用诸如聚合物管挤压成型的方法制造,导管筒直径在0.020到0.070英寸之间,优选地大约为0.035英寸,长度在50到150厘米之间,优选地为大约135厘米。所述导管筒22一般有亲水层(未示出)以减少摩擦。在所述导管筒22内有气囊充气腔26,所述气囊充气腔从所述导管筒22的近端23延伸到远端24。Luer型设备27固定于所述导管筒22的近端23,而且用溢流冒口28固定。
在气囊充气腔26内如图所示可有芯线31,延伸于导管筒22的全长,正如业界众所周知的那样这是为了提高导管筒的扭曲与伸展性能。
图1所示的气囊导管是快速变换型的,有导向线腔36,所述导向线腔有从邻近导管筒22的远端24的开口38开始延伸通过导管筒22的远端24的柔性细长元件37。普通的导向线39如图1所示穿过所述开口38,穿过所述导向线腔36一直延伸到导管筒22的远端24之外。应该了解也可以用普通的线上导管代替快速变换导管。
在导管筒22的远端24安装直径1.3毫米到10.0毫米,优选地为大约2.5毫米的普通充气—泄气气囊46,这种气囊用诸如聚乙烯、尼龙、聚(醚-酰胺)嵌段聚合物、或聚对苯二甲酸乙二酯之类的适当材料制造。所述气囊有近端47和远端48。所述近端47如图6所示用适当的材料,例如粘结剂,粘结于导管筒22。在气囊46内的导管筒上有射线透不过的标志49以便如下面说明的那样为气囊46定位。如果需要,可以有一对标志49。气囊的远端48用适当的材料,例如粘结剂,粘结于柔性细长元件37,从而提供一个有内衬53与气囊充气腔26连通的气囊46。所述气囊46可以用固定于设备27的充气装置(未示出)充气及泄气。所述气囊46有外表面54。
到目前为止说明的本发明的气囊导管基本上是传统的PTCA气囊。根据本发明,有多个柔性细长元件61在气囊的纵向上延伸于气囊46的全长并在气囊46的圆周相互隔开。一般使用一到六个柔性细长元件。这些柔性细长元件61可以是用适当的硬质柔性材料,例如,不锈钢、镍钛诺、尼龙、含氟聚合物和碳纤维制造的线或单丝形式。这种柔性细长元件61的直径在0.002到0.025英寸之间。所述柔性细长元件61有近端62和远端63。
在纵向上与气囊46的外表面54隔开的位置,设有把所述柔性细长元件61的近端62和远端63连接或固定于的装置导管筒周围的装置,使得这些柔性细长元件稍稍张紧。所述固定装置可以采用粘结剂、热缩管或对所述元件加热,使气囊的塑料软化,从而埋入所述塑料,保持在气囊的外表面54,并从而如图4所示坐入凹部66中。另外也可以把柔性细长元件61的端部62、63加热到熔点,然后固定到导管筒22上,而柔性细长元件37与气囊46离得较远。
例如,柔性细长元件61的远端63可以用紫外线固化粘结剂固定。近端可以用可熔化塑料套管固定于导管筒,放上后,把诸如聚四氟乙烯之类的可热缩材料的套管套于其外面,所述可热缩材料可以加热以便挤压接合处而使其下面的诸如尼龙之类的一个熔点比较低的材料的套管熔化。加热一开始,冷却亦即发生,就可移去可热缩套,从而导管筒22与气囊46之间保持平稳过渡,同时固定所述各柔性细长元件的近端,从而所述各柔性细长元件稍稍张紧并如图4具体所示的那样配置于气囊46的折叶或翼67之间的凹部66。然后,如图5所示,可把所述折叶或翼67逆时针方向或顺时针方向折叠起来盖在各柔性细长元件上形成光滑的圆形外表面以防止在引入气囊导管时及其后在血管内前进时损伤血管。可以在折叠的气囊上套圆管形气囊保护器(未示出),在运输和保存气囊导管时保护气囊。
现在可以在下面简要说明本发明的气囊导管的运作和使用了。拆去气囊导管的包装并从气囊保护器中拔出气囊。然后以一般方法把包着柔性细长元件的气囊沿导向线推进入血管中直到要处理的变狭窄或损伤处。所述损伤或变狭窄处可能是先天的损伤或变狭窄处或者可能是展伸的损伤或变狭窄处。气囊推进了多少一般可以用观察射线不能透过的标志49的位置认定。气囊一到适当位置即可把充气装置连接于近端,开始给气囊46逐渐充气。随着气囊开始充气,所述折叶或翼展开,然后气囊带着柔性细长元件61径向膨胀。所述柔性细长元件61与气囊的外表面54接合,并被径向向外推,进入血管壁上形成的变狭窄或损伤处,形成变狭窄或损伤内的纵向通道。通过选择适当大小的气囊和选择所需的压力,例如3到15个大气压力,形成所需大小的纵向通道。因为在损伤或变狭窄处形成了纵向通道,所述损伤或变狭窄处受到气囊壁外表面的压力可以更容易地扩大,形成所需的穿过损伤或狭窄处的流动通道。与传统的血管成形术相比这样做的结果对血管施加的力更小,血管的创伤也更小。
如果需要,气囊可以泄气,转动预定的量,再充气,在变狭窄处形成另外的纵向通道以进一步帮助扩张血管壁。
对狭窄处适当扩大后可以用一般的方法使气囊46泄气并从血管内撤出气囊导管。
如果需要,可以把本发明更大号的气囊导管引入血管进一步增大血管内狭窄处的开口。
图8-11示出的是本发明的另一实施例。可充气—泄气气囊71内配置柔性长管件72,所述柔性长管件有导向线腔73,导向线74配置于所述导向线腔内。与气囊导管21的上一实施例一样,也有多个柔性细长元件76延伸于气囊71的纵向上,这些元件有近端和远端(未显示),以上述同样的方法连接于导管筒(未显示)。所述柔性细长元件76不像柔性细长元件61那样横截面呈圆形,而其横截面一般呈三角形。所述截面三角形为等边三角形,各边中间稍稍凹进,其凹进程度相应于气囊71的外周。这有助于保证这些柔性细长元件如图11所示随着气囊膨胀而合适地坐于气囊的外表面上。
具有上述截面的柔性细长元件76可以用适当的方法制造,例如,拉动诸如不锈钢或镍钛诺之类的材料穿过合适的模具,或者,在聚合物的情形下,则用外形挤压法。图9和10所示的构形特别理想,因为三角形的顶尖78离开气囊71外表面并呈锋利的纵向刀样的切割刃,可以增强气囊71膨胀时所述柔性细长元件的切割性能,有助于进入损伤或狭窄处形成纵向通道以便于扩张通过血管内的损伤或变狭窄处的通道。
为了提高所述柔性细长元件和气囊71的纵向即轴向柔性,在所述柔性细长元件的纵向上制造许多分隔开的切口81,所述切口从所述顶尖78向下即向内延展适当距离,例如,三角形截面高的一半或三分之二。例如,与柔性细长元件61相比,柔性细长元件76的高可能在0.002到0.025英寸的范围内。切口81可以有适当的长度,例如1到5毫米;有适当的间隔,例如,1到5厘米。
可以很容易知道有了这种切口81,柔性细长元件76在纵向即轴向轴线上的柔性大大地提高气囊导管推过弯曲血管的性能。用柔软材料的填充物82填充切口81以便不严重降低柔性细长元件的轴向柔性。所述填充物82用适当的材料,例如,粘结剂或聚合物制造。应该了解,如果需要,柔性细长元件76可以没有切口,特别是在使用聚合物的情况下。
气囊导管的这一实施例的操作与使用,基本与对气囊导管21所作的说明相同。
图12示出的是包含本发明的气囊导管的又一实施例。图中所示的气囊导管86包括前面说明的那种导管筒87,在其远端安装气囊88。与前面的实施例一样,在气囊88的周边有多个互相隔开的柔性细长元件91沿所述气囊的纵向延伸。然而,在本实施例里,柔性细长元件91的近端和远端92和93是用柔性材料,例如,螺旋形弹簧制造的,在气囊88膨胀时即伸长并在气囊泄气时缩回或弹回以保持柔性细长元件91的拉力基本恒等,从而柔性细长元件91在气囊充气和泄气时紧密靠近气囊88的外表面。这种柔性近端和远端在气囊充气和泄气时调节柔性细长元件91长度的变化。这有助于保证柔性细长元件91在气囊充气和泄气时不会凹进气囊。应该理解不一定是在柔性细长元件91的两端都有柔性端部而是在其中至少一端有柔性端部,优选地设在近端。
图13、14和15内的气囊导管101示出的是本发明气囊导管的再一实施例。所述气囊导管包括导管筒102和安装于此筒远端上的可充气泄气的气囊103。多个柔性细长元件106各有近端107和远端108,所述近端和远端用适当的方法,例如,焊接,分别固定于环111和112,形成护架116。环111和112的大小做到气囊103在未充气的状态下能从其中滑过。这样,护架116可以预制,再在气囊导管制成后放在气囊外面。所述环111和112安装在气囊103上时互相隔开位于气囊103的两个相对端之外。正如说明的那样,这种护架116可以用所述方法用各个单独的零件组装,也可用所需材料制作的单个筒形件用激光切割而成或者用聚合物以一般的模塑法制成。
因此,如图14所示,护架116在气囊103泄气后可以滑过所述气囊,而且可以用前面实施例所述方法折叠气囊的折叶或翼盖于柔性细长元件106上。
气囊导管101的位置可以用前面实施例所述类似的方法定位。所述气囊导管到位后可以使气囊103充气,使护架116膨胀,用前述相同的方法在损伤或狭窄处形成纵向通道。本发明的这一实施例的优点在于所述护架形成一个单一的零件在气囊于血管内推进或拔出时不容易脱落。
从上述说明可以很清楚的看出,已经提供了一种在损伤处形成纵向通道的新的改进型气囊导管,提供了设定柔性细长元件与气囊相对位置的特别有效的方法,便于把所述柔性细长元件推到血管内的损伤或狭窄处而没有所述柔性细长元件与气囊分开的危险。用这种方法制造气囊导管特别有效,因为不要求对传统的制造PTCA气囊的方法作任何重大的改变。
Claims (19)
1.一种在血管内的损伤处完成血管成形术操作的气囊导管,该气囊导管包括有近端和远端的柔性长导管筒和固定于所述导管筒远端的气囊,所述气囊有近端、远端和内衬并能在充气与泄气状态之间转换,所述导管筒有从其近端延伸到其远端、并开口进入所述气囊内部的气囊通气道,设有一接头向所述充气道供应充气介质使气囊从泄气状态变到充气状态,所述气囊有从其近端延展到其远端的外表面,所述外表面在气囊充气时径向外移,至少有一个在所述气囊外表面上从所述气囊的近端延伸到其远端的柔性细长元件,所述柔性细长元件固定于所述导管筒的周围,其位置与所述气囊的外表面在纵向上分隔开,使气囊能膨胀并使所述柔性细长元件移动到与损伤处接触以在损伤处内形成纵向通道。
2.按照权利要求1的气囊导管,其特征为设有多个在所述气囊周边互相隔开的柔性细长元件。
3.按照权利要求1的气囊导管,其特征为所述柔性细长元件固定于所述气囊的近端,使所述柔性细长元件在所述气囊充气时作相对于所述导管筒的滑动。
4.按照权利要求3的气囊导管,其特征为所述柔性细长元件的远端固定于相对于所述气囊的一个固定的纵向位置。
5.按照权利要求1的气囊导管,其特征为所述柔性细长元件的近端和远端中至少有一端是用柔性材料制造的,使所述柔性细长元件在所述气囊充气时伸长而在所述气囊泄气时缩回。
6.按照权利要求4的气囊导管,其特征为所述柔性细长元件的近端和远端都是用柔性材料制造的。
7.按照权利要求1的气囊导管,其特征为所述气囊在泄气状态下折叠盖在所述柔性细长元件上以防止在把所述气囊推到血管内的损伤处时损伤血管。
8.按照权利要求1的气囊导管,其特征为所述柔性细长元件的横截面基本上是圆形的。
9.按照权利要求1的气囊导管,其特征为所述柔性细长元件的横截面基本上是三角形的。
10.按照权利要求9的气囊导管,其特征为:气囊的所述外表面在充气状态下横截面是弯曲的;横截面为三角形的所述柔性细长元件有凹进的表面以容纳充气后的气囊的弯曲外表面,在所述气囊膨胀带动所述柔性细长元件与血管内的损伤接触时所述气囊与所述柔性细长元件之间的配合更佳。
11.按照权利要求9的气囊导管,其特征为所述柔性细长元件有纵轴线并在纵向上有隔开的切口以增加所述柔性细长元件沿所述纵轴线的柔性。
12.按照权利要求1的气囊导管,其特征为在所述切口内放置填充材料。
13.按照权利要求12的气囊导管,其特征为所述填充材料是选自粘结剂或聚合物中的一种比较软的材料。
14.按照权利要求1的气囊导管,其特征为所述柔性细长元件是用选自不锈钢、镍钛诺、尼龙、含氟聚合物和碳纤维中的硬质柔性材料制造的。
15.按照权利要求2的气囊导管,其特征为所述柔性细长元件制成安装于所述气囊外面的护架的一部分,所述护架包括固定于所述柔性细长元件的分隔开的第一和第二环,所述环隔开足够的距离使得气囊的外表面与所述柔性细长元件接合,所述环的大小做到所述护架可滑动地安装于所述导管筒上并使所述护架在所述气囊处于泄气状态时能滑到并滑过所述气囊,在气囊充气时保持所述气囊与所述柔性细长元件接合。
16.一种制造在血管内的损伤处完成血管成形术操作的气囊导管的方法,制造一个有柔性长导管筒的气囊导管,所述柔性长导管筒有近端和远端,并有气囊配置于所述远端,安装至少一沿于所述气囊纵向延伸的柔性细长元件,所述柔性细长元件有近端和远端,把所述柔性细长元件的近端和远端固定于所述导管筒的周围使得这两端分别设成远离所述气囊的两个相对的端部。
17.按照权利要求16的方法,其特征在于还包括在所述气囊周边安装多个互相隔开的柔性细长元件。
18.按照权利要求17的方法,其特征为所述的柔性细长元件的近端和远端固定于所述导管筒。
19.按照权利要求18的方法,其特征为所述的柔性细长元件的近端和远端固定于两个环上,所述环的大小使得所述的环能滑过安装于所述导管筒远端的泄了气的气囊但在所述气囊充气时不能从所述气囊滑脱。
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Also Published As
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US20030153870A1 (en) | 2003-08-14 |
JP2005517474A (ja) | 2005-06-16 |
JP5014465B2 (ja) | 2012-08-29 |
WO2003068307A1 (en) | 2003-08-21 |
ES2693979T3 (es) | 2018-12-17 |
AU2003215210A1 (en) | 2003-09-04 |
EP1480709B1 (en) | 2018-10-24 |
EP1480709A4 (en) | 2007-01-10 |
EP1480709B8 (en) | 2018-12-26 |
JP4309286B2 (ja) | 2009-08-05 |
JP2009090131A (ja) | 2009-04-30 |
JP5123160B2 (ja) | 2013-01-16 |
JP2010179183A (ja) | 2010-08-19 |
US7186237B2 (en) | 2007-03-06 |
EP1480709A1 (en) | 2004-12-01 |
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