CN1626048A - 具有双稳态弹簧结构的可膨胀的设备 - Google Patents

具有双稳态弹簧结构的可膨胀的设备 Download PDF

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CN1626048A
CN1626048A CNA2004100751990A CN200410075199A CN1626048A CN 1626048 A CN1626048 A CN 1626048A CN A2004100751990 A CNA2004100751990 A CN A2004100751990A CN 200410075199 A CN200410075199 A CN 200410075199A CN 1626048 A CN1626048 A CN 1626048A
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stent
stable state
expandable device
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stable
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CN1626048B (zh
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佩得鲁斯·安东尼厄斯·贝塞尔林科
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Neikesensitan Limited by Share Ltd.
Nexen Medical Systems Inc
CeloNova Stent Inc
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KENTUCKY PETROLEUM Inc
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Abstract

本发明涉及一可膨胀的设备,具有一表面,所述表面由多个单元室(64)组成,每一单元室(64)具有一稳态的收缩构形(50)和一稳态的膨胀构形(60),所述稳态的膨胀构形(60)比所述稳态的收缩构形(50)包绕着一更大区域,每一单元室(64)包括第一和第二交联部分(66,68),第二交联部分(68)比第一交联部分(66)更柔软,所述可膨胀的设备的特征在于:所述多个单元室(64)中的每一个能够呈现所述稳态的收缩构形(50)或所述稳态的膨胀构形(60)。所述可膨胀的设备具有一种有负弹簧刚度和双稳态功能。

Description

具有双稳态弹簧结构的可膨胀的设备
本申请是已授予专利权的原申请(申请号:98802885.9;申请日:08/26/1999;发明名称:具有双稳态弹簧结构的斯滕特印模)的分案申请。
技术领域
目前市场上有许多种具有气囊可膨胀或自膨胀功能的斯滕特印模。气囊可膨胀的斯滕特印模通常由一种可以在两个方向容易塑性变形的材料制成。在插入前,斯滕特印模在一导管远端绕此气囊部分放置并一同压缩以减小外部尺寸。
背景技术
当斯滕特印模在适当的轴向位置放入身体中时,斯滕特印模可以膨胀并从而通过抽压气囊而塑性变形。在此最终状态,斯滕特印模处于其最大的直径并应能支撑周围的组织,防止至少局部变成一直径很小的不需要的形状。
因此,斯滕特印模需要在径向具有足够的刚度,但当其处于最终状态时还应在轴向具有一些柔性。而且,材料的量应尽可能少并且在内表面斯滕特印模不应阻止液体流过管道(例如血管)或引起太大的湍流。
这些斯滕特印模的问题通常如下:在将斯滕特印模绕气囊压缩至其最小直径后,斯滕特印模将总是具有一些弹性回到其略大的直径,当导管放入病人身体中时这会产生问题。另外,气囊和斯滕特印模之间的轴向摩擦力会很小以致于斯滕特印模滑出导管。而且,较大尺寸的一斯滕特印模通常是不利的。
另一个问题是这些斯滕特印模的所谓的缩回。这意味着在由气囊压力膨胀后,当气囊放气后外径会总是变得略小。这种缩回度可以高至
10%,这将引起斯滕特印模移动。
另一种不同类型的斯滕特印模由或多或少的弹性膨胀结构制成,它必须由某种外部装置保持在导管上。这种类型的一个例子是一斯滕特印模由一传送鞘保持在其限定位置上,当斯滕特印模应展开至其自然形状时可去除。
这些斯滕特印模中的某一些由形状记忆材料制成,要么具有超弹性特性要么具有温度敏感触发膨胀功能。
这些自膨胀斯滕特印模的一个缺点是需要传送鞘,从而产生较大的插入直径。鞘的去除还需要一鞘收缩机构,此机构必须在近端致动。
大多数上述两种斯滕特印模还具有在膨胀过程中长度变化相对较大及由于金属导线或支柱而使流体动力特性较差的缺点。
一些斯滕特印模的另一个缺点是具有正弹簧系数,这意味着只能通过更大的气囊压力才能取得更一步的膨胀。
现有斯滕特印模的结构通常使得在径向作用在斯滕特印模上的外力只在结构的支柱或导线上产生弯力。
例如,一由Johnson & Johnson International Systems生产的Palmaz-Schatz斯滕特印模的单元室或由Progressive AngioplastySystems公司生产的ACT One Coronary斯滕特印模在其收缩状态具有一平坦的矩形形状而在其膨胀的状态具有一或多或少的钻石形状,带有几乎直的支柱(Palmaz-Schatz型)或更弯曲的支柱(ACT-One型)。
这种斯滕特印模的单元室的形状基本对称,四个支柱中每一个都具有相同的横截面。另外,在轴向上室的载荷基本会使所有的支柱产生一弹性或塑性变形,使单元室在轴向伸长。这些单元室具有一正弹簧刚度。在基于这些单元室的斯滕特印模中抵抗径向压力的稳定性只取决于支柱及其连接的抗弯强度。
在已有技术中已公开塑性变形的斯滕特印模的其它构造。例如,文献WO 96 18359公开一种用于扩张血管的斯滕特印模,其包括一薄壁金属管构件,所述金属管构件具有一系列的穿孔,所述穿孔形成由交替的厚的、薄的柱形体界定的单元室。在内部压力作用下,所述斯滕特印模可径向膨胀,以致使所述薄柱形体塑性变形成任何所希望的最终形状。文献WO 9509584公开一种带槽管式的可膨胀斯滕特印模,其包括由相对较薄的横向部分偶连接的纵向部分。WO 96 09013公开一种可膨胀的管腔内的斯滕特印模,其包括一管状构件,所述管状构件具有多个刚性支承片,所述支承片由相对较薄的可塑性变形的连接部接合。所有这些斯滕特印模拥有正则的弹簧系数,需要施加渐增的径向力来达到一所希望的塑性径向变形程度,而且在膨胀之后都经受某种程度的回弹,以致所述斯滕特印模的精确的最终膨胀直径是未知的。
发明内容
在本专利申请中描述了一种新型的斯滕特印模,具有一表面,所述表面由多个单元室组成,每一单元室具有一稳态的收缩构形和一稳态的膨胀构形,所述稳态的膨胀构形比所述稳态的收缩构形包绕着一更大区域,每一单元室包括第一和第二交联部分,第二交联部分比第一交联部分更柔软,所述斯滕特印模的特征在于:所述多个单元室中的每一个能够呈现所述稳态的收缩构形或所述稳态的膨胀构形。
这种斯滕特印模具有一种有负弹簧刚度和双稳态功能的单元室。这种单元室还可以用于其它的医疗应用中。这意味着它具有两种构形,其中它不需要外力保持其形状而可以稳定。单元室使用至少两个不同的区段而形成。一个区段不如另一个柔软并起相对刚性支撑的作用,防止此更柔性的区段在一个方向中形状变化。在另一个方向柔性区段可以变形,但由于来以刚性区段的抗力,柔软或柔性区段的稳定性可以得到很大的增强。
在垂直于最柔性区段方向上的外力分布到刚性区段上而且柔性区段的横截面只在压缩状态下承受载荷。这使得结构比现有的斯滕特印模更牢固。在现有的斯滕特印模中,所有的支柱通常具有相同的横截面和机械特性并只用于弯曲模式中。
基于此单元室的一种斯滕特印模的结构产生了一种设备,可以容易地用手施加压力而绕气囊压缩。
在一特定关键直径之下,本发明的斯滕特印模进一步弹至一稳定的、最小的直径,从而将放气的气囊牢固保持在导管的表面上,其中一插入直径尽可能小。不需要额外的鞘,但也可以用来保证更安全。
在斯滕特印模在适当的轴向位置放入病人身体中后,气囊可以充气直到斯滕特印模到达其临界弹性平衡直径。略高于此直径之上斯滕特印模自动进一步膨胀至其最终最大的直径,其中它抵抗径向压力到达其最大稳态。此设计可以取得一恒定长度的大的膨胀率,一可靠的可膨胀性和/或一小的表面率。
优选地,所述的多个单元室中的每一个能够等温地呈现所述稳态的收缩构形或所述稳态的膨胀构形。
优选地,所述多个单元室构造和设置成使得所述单元室可通过对所述斯滕特印模的一内表面施加一均匀的径向指向的力而在所述两稳态构形间转换。
优选地,所述多个单元室的一第一子集包括具有一第一刚性的第二部分,而且所述多个单元室的一第二子集包括具有第二刚性的第二部分;所述第一刚性不同于所述第二刚性。
更优选地,当在所述稳态收缩构形和相继的多个离散的稳态的膨胀构形之间转变时,所述多个单元室经受弹性变形。
有利地,所述的多个单元室中的每一个能够在所述稳态的收缩构形和相继的多个所述稳态的膨胀构形等温地呈现。
有利地,所述多个单元室构造和设置成使得所述单元室可通过对所述斯滕特印模的一内表面施加一均匀的径向指向的力而在所述两稳态构形间转换。
有利地,所述多个单元室的每一个具有一均衡的中心位置,并具有一绕所述均衡的中心位置的不对称负载-位移特性,其中,所述膨胀构形是每一单元室的最稳定构形。
有利地,所述多个单元室的每一个具有一均衡的中心位置,并具有一绕所述均衡的中心位置的不对称负载-位移特性,其中,所述收缩构形是每一单元室的最稳定构形。
有利地,所述多个单元室的一第一子集包括具有一第一刚性的第二部分,而且所述多个单元室的一第二子集包括具有第二刚性的第二部分;所述第一刚性不同于所述第二刚性。
本发明的另一个实施例使一种带有一系列稳定直径逐级膨胀的斯滕特印模成为可能。
本发明的另一部分是一种沿其长度带有几个外径的斯滕特印模,以尽可能适应它放入其中的身体腔室的形状。
本发明的还一部分是通过热处理修正单元室中的应力应变分布,使此单元室的力位置特性不对称或甚至表现为单稳态而非双稳态功能,其中要么带有膨胀后的直径,要么是最稳定状态的收缩的直径。
本发明的另一个实施例是修改一些支柱的横截面几何形状,以取得抵抗一单元室位移特性的对称或非对称的双稳态或单稳态力。
本发明的还一部分是在其它的医疗应用场合例如一膨胀器或环中使用一个或多个单元室,要么将一身体腔室扩张开,要么夹紧或保持一身体部分或某些身体组织。
本发明还针对将本发明的斯滕特印模与本发明的膨胀环结合起来使用以将两个脉管连接在一起。
本发明还针对一种具有一速动的双位置单元室的双稳态阀及其使用,尤其是防止失禁。
本发明还针对多稳态室及其在医疗装置中的使用。
本发明的斯滕特印模的结构包括一系列部件,带有一种能以特殊方式稳定的单元室布置。每个单元室具有至少两个不同的机械连结的、机械特性不同的区段。一个区段对较柔性的反作用的区段起一相对刚性支撑的作用。较柔性区段对如果不是全部也是大多数斯滕特印模的膨胀起作用。有许多方法可以制造基于此原理的一斯滕特印模,而且它可以由许多材料制成,像聚合物、复合物、常规的金属或具有超弹性特性或温敏特性的形状记忆合金。
它可以由一种线或条带布置方式制成,在特定位置熔接一起。另一种可能性是在基片中将金属沉积在所需的图案中或使用烧结预合金粉末。
一种进一步的方法是由一管形的原材料加工斯滕特印模,利用蚀刻,碾磨、切割(例如用激光、水等)、电火花腐蚀加工或任何其它适当的方法在壁上形成条或带的图形。此图形还可以在一平板中形成,然后熔接、铜焊或卷曲成大约为圆柱形或一圆柱形中间部分带有两个直径较大的圆锥端。
附图说明
图1示出一双稳态结构的原理;
图2示出图1结构的力-位移特性;
图3示出另一种带有一不对称双稳态的双稳态结构;
图4示出图3结构的力-位移特性;
图5a示出处于稳定的完全收缩构形中的本发明的管状斯滕特印模;
图5b示出处于稳定的完全膨胀的构形中的一本发明的管状斯滕特印模;
图6示出带有一稳定膨胀形状的双稳态单元室的一斯滕特印模的一部分;
图7示出图6的斯滕特印模的部分接近其弹性稳定平衡状态;
图8示出图6和7的斯滕特印模部分处于其稳定的收缩形状;而
图9示出图6和8的斯滕特印模的较大的区段,示出了一些单元室处于收缩形状而一些单元室处于膨胀形状。
图10示出由多个较小的本发明的斯滕特印模用柔性接头连在一起形成的一本发明的斯滕特印模。
图11示出具有多于一种双稳态单元室类型的一局部膨胀的本发明的斯滕特印模。
图12示出沿其长度具有一系列直径的一本发明的斯滕特印模;
图13示出处于膨胀状态中的一本发明的膨胀环;
图14示出处于收缩状态中的图13的膨胀环;
图15示出将两个脉管连在一起并装有本发明膨胀环的一本发明的斯滕特印模,其中斯滕特印模位于脉管外部;
图16示出沿图15中线16-16的一剖视图;
图17示出将两个脉管连在一起的一本发明的斯滕特印模,其中斯滕特印模位于脉管内部;
图18示出用一本发明的膨胀环和一夹紧器连在一起的两个脉管;
图19示出处于闭合状态的一双稳态阀;
图20示出处于打开状态的图19的双稳态阀;
图21a示出处于完全收缩状态中的一多稳态室;
图21b示出处于完全膨胀状态中的图21a的多稳态阀;
图22a示出处于完全收缩状态中的另一多稳态室;
图22b示出处于完全膨胀状态中的图22a的多稳态室;
图23示出几个图21a、b所示的单元室连在一起并处于完全膨胀状态中;
图24a示出几个图22a、b所示的单元室连在一起并处于完全收缩的状态中;
图24b示出处于完全膨胀状态中的相互连接的图24a的室;
图24c示出在膨胀过程中的相互连接的图24a的单元室;
图24d示出连在一起并处于膨胀过程中的几条相互连接的图24a、24b中的室。
具体实施方式
图1示出斯滕特印模的原理,图1a示出了长度为L的一个杆1,在其轴向受压;杆1到达其屈服应力。然后杆的中间部分将向侧向弯出,或者到位置2或者到位置3(在图1b中虚线)。当杆端的轴向位移ΔL由外部夹紧器4保持稳定时,可以在两个稳定位置2和3之间移动杆的中间部分。此移动在X方向,垂直于杆的原长轴线A-A。所有在稳定位置2和3之间的位置都不稳定。在图1b中杆的中间部分在杆可以在X方向移动之前必须转动一β角。图1C示出了杆1中的一第二序列曲率,在当β角的转动通过压紧杆1的中间部分并保持此部分平行于A-A轴线时产生。
图2示出了做为位移X函数的力F,其中X在水平方向移动。杆从图1的上稳定位置2向下稳定位置3移动。力从零快速增加至Fmax。到那时要么到达图1b的第一序列曲率,要么到达图1c的第二序列曲率。在X方向进一步的位移需要较小力,因为此弹性装置有一负弹性刚度。力在中间位置甚至为零而进一步的移动自动进行。从图2中可见此装置完全对称而需要从下部位置回到上部位置的力具有相同的特性。
图3示出了杆5,它具有一不对称的力位移特性,因为它已具有一预置的曲率,甚至在载卸位置中长度已是L-ΔL。这可以由先前的塑性变形、热处理或使用杆的不对称横截面(未示出)而取得。图3中的杆5安装在两个夹紧器4之间长度为L-ΔL,而且如果它以同图1b和1c中相同的方式弹性变形,同图1的杆相比它将在最终位置2和3中在横截面中具有不同的应力分布。这意味着如图3所示杆处于一优先卸载的稳定状态。
图4示出了图3预弯的杆的不对称的力-位移特性。来自稳定的上部位置的初始位移需要一启动力F1,而且如果杆位于其稳定的下部位置时,在相对方向中的启动力只有F2,小于F1。力F2可以根据需要很小,甚至是零或负值。但如果需要下部位置稳定则需要为正值。
图5a和5b分别示出了本发明的管状斯滕特印模在完全收缩和完全膨胀的构形中的总体形状。在其通常如50示出的处于完全收缩状态和其如60示出的处于完全膨胀状态的斯滕特印模包括多个相互连接的双稳态单元室(如图5b中的膨胀状态下的64所示)。双稳态单元室由一第一相对刚性部分52(图5b中的66)以及一第二相对柔性部分54(图5b中的68)形成,在端部70和72连在一起。第二相对柔性部分68与相邻的相对刚性部件66相互连接。在纵向(纵轴由标号75表示)相邻的室在端部70和72相连。通过施加一均匀的径向向外或向里的力,斯滕特印模可以直接从一完全收缩状态转变为一完全膨胀状态,或相反。
图6(相当于图5b中的局部插图6)示出了图5中所示的斯滕特印模的一小部分,它使用了本发明的一单元室的双稳态功能。图中示出了一水平线A-A,平行于斯滕特印模的中心轴。有两条尺寸不同的正弦曲线段(还可以参见图9的总体视图)。部分7和9具有相对大的横截面。其中只全部示出了部分9。部分9和10具有相对小的横截面,这里只全部示出了部分8。这些部分例如通过焊接在接点11、12相互连接。
由于部分8和9横截面之间的差异,部分8的变形力比部分9的小许多。因此,部分9可以认为是一相对刚性的夹板,就象图1b中的夹板4一样抵抗在接点12之间在轴向平行于轴线A-A的相对位移。相反,部分8起一柔性杆的作用,就象在图1中所述的杆1和图3中所述的杆5。部分7和8或9和10的组合限定了一个单元室,根据卸载条件和部分的几何形状起一带有象图2和4所示的曲线的力-位移曲线F-X的双稳态弹簧装置的作用。或者,不使用直径不同的部分或支杆,这些部分可以具有相同的直径(即横截面积)并表现出不同的强度或刚度而且仍具有相同的效果。一种取得强度或刚度不同的方法可以是对这些部分使用不同的材料。另一种方法是对所有部分使用相同的材料如一种金属,但对这些需要具有刚性的部分选择使用强化(如热处理)方法。应注意到热处理不能强化所有材料。例如镍钛金属互化物热处理后会更软。但镍钛金属互化物的这一特性可以用来使镍钛金属互化物的一段相对于没有经过热处理的第二段镍钛金属互化物更软。
图7示出了接近弹性平衡状态的同一部分斯滕特印模(如图6所示)。部分8由力F在X方向变形,但部分9几乎保持其原来的形状,因为其刚度较大。
图8示出了图6至7的斯滕特印模的相同的单元室在受压经过弹性平衡状态后的情况。它自动卡入其图8的稳定状态,此卡合力可以足够大,取决于用于制造这些部分的材料的特性(如强度)以将一放了气的气囊紧固在导管轴上(未示出)。凭借在这些图中示出的几何形状,部分8和9紧密配合在一起,当此斯滕特印模位于其最小的稳定的直径时占用最小的空间。
图9示出了图5的斯滕特印模的一段,为了示意性目的为倒平状态,示出了几个处于压缩稳定形状的柔性区段(区段14、18和20)以及一个处于膨胀稳定形状的区段16。区段13、15、17和19是相对刚性的区段并基本保持其原始形状。两个相对刚性区段之间的距离在压缩稳定形状中用h表示而在膨胀稳定形状中用H表示。在X方向位移H-h的数值取决于一个膨胀的单元室的高度或区段的大小以及连接头的尺寸。斯滕特印模的所述部分以一平的表面示出,但很清楚在图5中所示的圆柱形斯滕特印模的形状可以是区段13和20可以彼此用接头21直接相连。换句话说,斯滕特印模表示成沿接头21分离并处于一倒平状态下。
每当一柔性区段从压缩的稳定状态咬合至膨胀的稳定状态时,斯滕特印模的稳定直径的范围就随着(H-h)/π的值而变化。结果在所有直径都有刚性极大表面的一斯滕特印模能比常规的斯滕特印模较好地承受外力。在长度方向,斯滕特印模的柔性可以通过断开几个单元室与其相邻单元室的连接例如通过切断一个或多个接头的中间同时保持这几个接头件为接头而增强。
另一种增强柔性的方法是沿斯滕特印模全长在长度方向从相对柔性至相对刚性形状改变几段单元室的几何形状几次。换句话说,参见图9,一个或多个或每个区段13至30可以构造成较大和较小的直径(或柔性和刚性)段,这些段在每个接头21之后交替。
另一种可能性是如图10所示使用一系列在长度方向端部和端部对齐并用与形成各个单元室的接头具有相同或不同几何形状或结构的柔性接头104连接的短多稳定性斯滕特印模100。
本发明的范围应包括所有类型的材料。最常用的一种材料是超弹性镍钛金属互化物,因为它具有大的弹性强度,分布合理的应力值,通过热处理由其平稳应力和将所需的曲率限定至金属中的可能性产生。一镍钛金属互化物斯滕特印模可以通过将长条或板条形成一管件同时形成其收缩或较小的稳定直径而制成。板条形管件于是由一单独的成形工具膨胀并在此工具上热处理以将膨胀的稳定直径限定成没有应力的形状。
通常,本发明针对一种具有多个稳定结构的装置。此装置由多个相互连接的多稳定性室组成。这些室包括相互连接的一个或多个相对刚性区段和一个或多个相对柔性区段,以限定具有多个稳定构造形状为多稳定弹性装置的室结构。在一优选实施例中,这些室包括一具有第一和第二端的第一弧形件和一具有第一和第二端的第二弧形件,第一弧形件的第一端与第二弧形件的第一端相通,而第一弧形件的第二端与第二弧形件的第二端相通。但应注意到这些部件不需要是精确的弧形。其它形状的部件包括相对较直的部件也可以使用。
本发明具体地是针对双稳态室,即具有两种稳定构造的室。在这样一个室中,第一和第二区段上相应点之间的距离在室的第一稳定状态下比在室的第二稳定状态下要较大。这些室本身构造和设置成装置本身至少是双稳态以及可能是多稳态的。以上已经描述了具有两个或多个结构带有一初始直径尺寸和一最终较大的直径尺寸的一圆柱形斯滕特印模的这样一种装置。但本发明也考虑多稳态的斯滕特印模。于是例如一斯滕特印模可以构造成其中这些室设计和设置成可以提供一系列逐级增大的直径。可以完成的这样一种方法可以在斯滕特印模中用于几种不同类型的室,每种类型的室都具有不同的弹簧刚度,这样取决于使用的力的量值,斯滕特印模具有不同的直径。处于局部膨胀状态的这样一种斯滕特印模在图11中示出。一局部膨胀的斯滕特印模通常表示为120。斯滕特印模由基本保持其原始形状的相对刚性的部分123、127、131和135以及相对柔性的部分125、129和133组成。这些部分由接头122相互连接。如上所述,第一柔性件125和133处于一种膨胀构造而第二柔性件129处于一种收缩构造。通过施加一径向向外或切向力,柔性件129可以翻至其完全膨胀的构形,产生一直径较大的斯滕特印模(未示出)。如图11所示,室138即使在收缩状态也比室136大。第一柔性件125和133的特征是与第二柔性件129相比柔性度不同。
图12所示的另一种形状的斯滕特印模150在一第一端152具有一第一直径,在第二端154具有一第二直径,第一端152和第二端154之间的区域156具有一个(或多个)中间直径,中间直径与第一和第二直径不同。在图12中通常以150表示的这样一种斯滕特印模中的相互连接的室可以都有相同的力常数,因此可以用适当需要的力同时打开,或者它们可以是几种不同类型的室,每个都有自己的力常数。为了取得多个直径,可以使用不同尺寸的室。在这种斯滕特印模的一个实施例中,第一和第二直径相同而在另一个实施例中,第一和第二直径不同。
本发明还针对一种移植具有多个稳态构形的一种可膨胀的斯滕特印模的方法。此方法的步骤包括:将斯滕特印模施加到一导管上的一膨胀装置上,将斯滕特印模送至一所需的身体部位,膨胀所述膨胀装置以使斯滕特印模从一第一状态构形膨胀至一所需的第二稳态构形,其中第二稳态构形的直径比第一稳态构形大,并将膨胀的斯滕特印模布置在所需的身体部位。此膨胀装置可以是一气囊、在导管上或导管中的一机械装置、一通过加热使导入的室改变状态的热源,或者其它合适的膨胀装置。斯滕特印模可以在第一稳态构形中施加到气囊上,或者可以在施加过程中在第二稳态(膨胀)构形中施加。在后一种情况下径向向内的压力可以施加到斯滕特印模上将斯滕特印模压入第一稳态构形以将其卡入导管上。由于斯滕特印模具有其它的稳态,斯滕特印模可以在一中间稳态施加到气囊上,其中斯滕特印模的直径处于第一状态直径和第二状态直径的中间值。另外,可以通过进一步施加一径向向里的压力而将斯滕特印模锁在膨胀装置上。
本发明的另一个目的是使用一单独的双稳态单元室做为一膨胀器(膨胀环),这样可以送入一窄空间中并从而受触发以弹回至其膨胀的稳态中。如图13所示一通常以其膨胀状态示出的膨胀环250包括一具有第一端258和第二端262的第一刚性件254以及一具有第一端270和第二端274的第二柔性件266。第一部件254的第一端258连在第二部件266的第一端270上,而第一部件254的第二端262连在第二部件266的第二端274上。图14示出了图13的膨胀环处于其收缩状态。第二部件266可在一第二稳定状态中看出。
本发明的另一个目的是使用一单独的双稳态环(单元室)做为一夹钳,这样可以用来夹住一动脉、输卵管或其它身体部分,以便在某些情况下关闭或夹住它。对这样一种夹钳必须限定收缩的稳定形状做为未变形的形状,因为收缩的稳态形状是最稳定的。在收缩状态,夹钳可以类似图14的收缩的膨胀环。一触发装置可用来连接夹钳以将双稳态环从一个状态转换为另一种状态。触发装置可以是气动、液压、机械、热或机电装置。这种触发装置的实例包括向双稳态环施力的人手以及向环加热的情况。其它触发方式包括拉伸此装置、压此装置,使此装置的刚性区段弯曲或释放保持柔性件的约束力使其到位。
本发明的另一部分涉及在本发明一个或多个环形部件之间的结构,与加固的或保持同这些部件打开的一管状套筒相结合。一个例子是由一种聚合物制成带有一个或多个膨胀环的所谓的移植的斯滕特印模。膨胀环可以由上述双稳态室构成。斯滕特印模的表面包括安装在膨胀环上的一表皮。在安装表皮时,表面可以围绕,位于膨胀环中或其之间。表皮可以是人或动物的皮肤,一种聚合物材料或任何其它适当的生理上相容的材料。这样一种斯滕特印模可以包括一个或多个膨胀环,例如在斯滕特印模的第一端有一第一膨胀环,而在斯滕特印模的第二端有一第二膨胀环。斯滕特印模可以沿其长度直径恒定,或者可以在第一端有一第一直径而在第二端有一第二直径。
本发明还针对一种具有一未膨胀的构形和一膨胀的构形的斯滕特印模,并包括多个通常纵向的波状的第一构件,具有一第一波长并具有波峰和波谷,以及多个通常纵向的波状的第二构件,具有一第二波长并具有波峰和波谷。第一和第二纵向构件的波长基本相等。第二构件能稳定地位于两个位置,一第一位置相应于未膨胀的构形,其中第一和第二构件同相,一第二位置相应于膨胀的构形,其中第一和第二构件成180°的反相。第一构件比第二构件刚度更大。第一和第二纵向构件设置在斯滕特印模表面以便纵向的第一和第二构件交替变化。在未膨胀状态,每个第一构件的每个波峰在一连接区连到一第二构件的一相邻的波峰上,而每个第一构件的每个波谷在一连接区连到一第二构件的一相邻的波谷上,从图9中可见。连接区沿纵向间隔一个波长。可以通过施加一径向向外的力将所述的斯滕特印模从未膨胀构形压至膨胀的构形,同时可以通过施加一径向向内的力将斯滕特印模从膨胀的构形压至未膨胀的构形。尽管这种斯滕特印模可以用在一身体脉管内部,但它也可以用在脉管外将两个脉管连在一起。
本发明还针对一种将两个脉管连在一起的方式,步骤包括将一本发明的处于第一稳态未膨胀构形的斯滕特印模送至一身体位置上,将斯滕特印模膨胀至一第二稳态,在第二稳态下斯滕特印模直径超过要连接的脉管,然后将斯滕特印模将置在要连接的脉管上。然后斯滕特印模可以收缩至一第三稳态,在第三稳态中的斯滕特印模的直径介于处于未膨胀状态中的斯滕特印模和在第二稳态中的斯滕特印模的直径之间。斯滕特印模还可以借助于一个或多个上述的膨胀环(一双稳态环)安装到脉管上。一个或多个膨胀环例如在图13和14中所示的或小夹紧斯滕特印模(例如由图23中所示的细条形成)可以送到处于收缩状态的斯滕特印模的每一边并使用以将脉管夹在环(或这些环)之间。可以使用多个环进行额外夹紧。通常如图15中的300所示,一第一脉管304和一第二脉管308用本发明的斯滕特印模312连在一起。脉管304在一第一重迭区316与斯滕特印模312重迭,而脉管308在一第二重迭区320与斯滕特印模312重达。脉管304夹在膨胀环324(在膨胀状态中示出)和斯滕特印模312之间,而脉管308夹在膨胀环328(只为示意性目的在未膨胀状态中示出)和斯滕特印模312之间,与膨胀环328相连的虚线示出在其膨胀状态中的膨胀环328。还应注意图15提供了一脉管的局部视图,示出了包含在其中的环,图16示出了沿图15中16-16线的一剖视图。图中示出脉管304夹在斯滕特印模312和膨胀环324之间。
在另一实施例中,如图17所示,一第一脉管404和一第二脉管408由一斯滕特印模412连在一起。斯滕特印模412的第一端416位于脉管404中而斯滕特印模412的第二端420位于脉管408中。可选择的夹紧器(例如后面在图23中以条形示出的本发明可收缩的斯滕特印模的一小部分)424和428位于脉管404和408外侧上将斯滕特印模夹紧在脉管上。如需要可以使用另外的夹紧器。
在图15和17的实施例的组合的另一实施例中,斯滕特印模的第一端可以从一个脉管伸出而斯滕特印模的第二端可以伸过第二个脉管。而且,夹紧器和膨胀环可用于进一步将斯滕特印模安装到脉管上。
如图18所示在另一个实施例中,脉管454和458由脉管内的一膨胀环462以及一夹紧器466固定在一起,构成例如可收缩斯滕特印模的一小部分,斯滕特印模经过挑选使得处于收缩状态的斯滕特印模的直径对脉管454和458以及膨胀环462提供一滑动配合。要么膨胀环要么夹紧器但不是全部可以由一适当的支撑如一刚性挡圈替换。
本发明还针对一种将两个脉管连接在一起的方法,步骤包括将处在第一稳态的一未膨胀构形中的本发明的斯滕特印模送至一身体部位,将两个身体脉管放在斯滕特印模上并将斯滕特印模膨胀至一第二稳态,在第二稳态中的斯滕特印模的直径超过要连接的脉管的直径。在第二稳态中的斯滕特印模的直径最好选择成脉管可以在斯滕特印模上宽松配合。斯滕特印模的传送可以通过将处于一未膨胀构形中的斯滕特印模通过一身体脉管传送并随后膨胀斯滕特印模以松驰地位于要连接的脉管中(其中一部分斯滕特印模存留在一脉管中)而完成,或通过膨胀斯滕特印模至其完全膨胀状态,将斯滕特印模放在脉管上并随后将斯滕特印模收缩至一中间状态位于脉管上而完成。上述挡圈和膨胀环可以类似地传送。或者,斯滕特印模、挡圈和膨胀环可以通过用外科手术打开所述脉管而传送。
本发明还针对一种双稳态阀。如图19中600所示的此阀包括一位于一导管606中通常以604示出的速动双位置单元室。速动双位置单元室604包括一(基本为弧形的)柔性件608,具有一第一端612和一第二端616。第一端612与一触发装置620相连,而触发装置620由一从导管606的内表面中伸出的支撑装置624支撑。柔性件608的第二端616固定在横穿导管606延伸的阻挡表面628上。支撑装置624和阻挡表面628必须有充足的刚性以将柔性件608固定到位并必须比柔性件608刚性更大。阻挡表面628在倾斜区630基本倾斜地横穿导管606延伸并在纵向区634中具有一开口632,以使流体可以通过其流动。尽管开口632沿导管606的纵向轴线636定位,但本领域普通技术人员可以找出其它可能的开口和阻挡表面的定位方式。由柔性件608在打开和关闭位置之间致动的阀关闭件640构造和设置成当柔性件608处于关闭状态时可以挡住液体流过开口632。当柔性件608位于打开状态时,如图20所示阀关闭件640不再堵塞开口632,从而使液体可以经开口流动。
尽管触发装置620可以是任何合适的本领域目前或将来公知的机械、液压、气动或基于热的触发器,但在一优选实施例中,触发装置620是一压电部件。在操作中,如果图19中以620示出的压电件没有致动,阀关闭件640关闭。如图20所示压电件620的致动使压电件620的纵向长度(在图15中由Y示出)略变短,反过来使柔性件608从其第一位置释放。随着部件608的释放,阀关闭件640在由液体传送的压力作用下自由打开。如图20所示部件608位于一第二的头朝下的状态。尽管液体压力使部件608保持在其第二状态,但如图20所示如果关闭触发且压电件620处于其原始长度时,甚至在没有任何液体存在时部件608也保持在其第二状态。在有液体存在时通过随后触发压电件620使部件608过渡至其第二(关闭)状态可以重新关闭阀关闭件640,其中此第二(关闭)状态是部件608的优选位置。部件608已经过处理可以承担如图3所示一优选状态。
在图19和20中示出的阀可以用于医疗或非医疗装置上。尤其是本发明的一个目的是将本发明的双稳态阀用于控制泌尿失禁。在失禁病人中,上述阀可以使用任何合适的装置包括使用上述膨胀环将阀夹紧到尿道上而移植到尿道中。尽管在缺省状态下阀是关闭的,但阀可以当膀胱盛满时触发膀胱以排泄。当膀胱排泄时,阀可以重新触发以关闭它。另一个这样的应用是与一分流器一同使用本发明的阀。分流器可以通过触发此装置而致动并同样可以通过触发此装置而关闭。
当然阀也可以用于其它的医疗和非医疗场合下。
除了以上公开的双稳态单元室外,本发明还针对其它形状的双稳态单元室和更通常的多稳态单元室。图21a和21b分别示意性地示出本发明铰结的处于其收缩和膨胀状态的另一实施例。如700所示的收缩的室和如705示出的膨胀的室,包括四个相互连接的相对刚性的部件。两个侧部件709由铰结715连到顶部件713的相对端上。侧部件709由铰结719连到底部件717的相对端上。最好铰结是弹性的或可塑性变形的。铰结可以固定连接到侧、顶和底部件上或可以与这些部件成为一体。在后一种情况下,铰结可以通过在室的铰结区去除材料而形成,以便铰结变薄或具有不同于侧、顶和底部件的几何形状。在从膨胀向收缩状态过渡的过程中,底部件717略张开。图21a、b的室还具有另外的中间状态,其中一个或另一个(但不是全部)侧部件709和顶部件713向下收缩。
一六边形铰结的多稳态单元室在图22a中以收缩状态而在图22b中以膨胀状态示意性地示出。以750示出的室包括顶部754和底部件758以及上侧部件762。两个侧部件762由铰结756连在顶部件754的相对端上。上侧部件762由铰结768连到底部件758上。底部件758形如一“U”形,其中“U”形的两个直边改成相对于“U”形的底部倾斜。对上述本发明的室而言,铰结756和768可以是弹性的或塑性变形的并可以固定连接到部件上或与部件成为一体。六边形单元室表现多稳态。除了图22a和22b所示的完全膨胀和完全收缩状态外,六边形室还可以取得两个中间稳定构形,其中两个上侧部件762中只有一个沿上部件754向内收缩。
上述铰结的多稳态室可以用于上述任何一种场合,如形成斯滕特印模、夹紧器、夹钳、膨胀环、双稳态阀。
在这样一种应用场合中一环或斯滕特印模由图21a和21b的铰结的室形成。如图23所示,如图21所示类型的一系列单元室连在一起,这样一室的顶部件形成一相邻室的底部件的一部分。如图所示,室810的顶部件814形成室820的底部件818的一部分。同样,室828的顶部件824形成室836的底部件832的一部分。尽管图23的环或斯滕特印模为了示意性目的已截断,但两端840和844通常由起室856一上部件的作用的室852的下部件848的一部分连在一起。这样形成的环具有包括一完全膨胀状态和一完全收缩状态的一系列稳态。每个室都做成一样,只有完全膨胀的状态可以通过向处于完全收缩状态的斯滕特印模施加一均匀径向向外的力而获得。它可以起一夹紧器或挡圈,一膨胀环或一斯滕特印模的作用。通过相互连接多个这样的环可以形成较大的斯滕特印模。
还可以由其它的多稳态单元室形成相似的产品。图24a和24b示意地示出这样一个,其中如图22a、b所示的那些六边形单元室可以连在一起形成一个环。每个室880的顶部件884连在一底部886上或修正的‘U’形底部件上890上。尽管在图24a和24b中以条形示出,端部894可以连在端部898上以形成一个环。图24a的条在图24b中以完全膨胀状态示出。相邻的室880位于其膨胀状态中。为了完整性的缘故,铰结以902示出。图24c示出一个在膨胀过程中的室920和一个已膨胀的室924。室920和924在底部件928和顶部件932相连。铰链以936示出。多个条还可以连在一起以形成一斯滕特印模,其长度是单元室长度的倍数。在这种情况下,相邻室的上侧部件可以连在一起。这在图24d中示出,同图24c一样图24d示出在膨胀状态中的室940和处于膨胀过程中的室944。上侧部件948由虚线示出。相互连接的室952的相邻的条由上侧部件948以及由底部件960的倾斜区956连在一起。
应注意到本发明这种应用的装置可以在人体内临时或永久使用。这样例如永久的斯滕特印模和夹紧器同可去除的斯滕特印模和夹紧器一样进行考虑。
另外还应注意到在膨胀某些本发明的多稳态室时,在垂直于施加膨胀室的力方向的方向中可以有膨胀/收缩部件。
最后,为此应用目的,术语“多稳态”包括“双稳态”。
在所述的附图和文本中只给出某些不同实施例的例子。尽管本发明的斯滕特印模可以与现有技术的斯滕特印模类似,但由于在同一个单元室中一刚性区段和一柔性区段的特殊组合,使得机械效果完全不同。当然除了示出的正弦曲线曲线形状外单元室还可以有其它可能的基本形状,而特性状况相似。
从本发明基本原理的上述公开文本和以上的详细描述中,本领域普通技术人员可以容易地理解本发明可能的各种修改。本发明的应用范围包括一种或多种材料的不同的几何形状、不同的结构和不同的组合,以获得由上述例子展现的相同的基本机械状况。

Claims (10)

1.用于支持一通路的可膨胀的设备,所述可膨胀的设备具有一表面,所述表面由多个单元室(64)组成,每一单元室(64)具有一稳态的收缩构形(50)和一稳态的膨胀构形(60),所述稳态的膨胀构形(60)比所述稳态的收缩构形(50)包绕着一更大区域,每一单元室(64)包括第一和第二交联部分(66,68),所述第二交联部分(68)比所述第一交联部分(66)更柔软,所述可膨胀的设备的特征在于:所述多个单元室(64)中的每一个能够仅呈现所述稳态的收缩构形(50)或所述稳态的膨胀构形(60)。
2.按权利要求1所述的可膨胀的设备,其特征在于:所述的多个单元室(64)中的每一个能够等温地仅呈现所述稳态的收缩构形(50)或所述稳态的膨胀构形(60)。
3.按权利要求1所述的可膨胀的设备,其特征在于:所述多个单元室(64)构造并设置成使得所述单元室(64)可通过对所述可膨胀的设备(50,60)的一内表面施加一均匀的径向指向的力而在所述两稳态构形(50,60)间转换。
4.按权利要求1所述的可膨胀的设备,其特征在于:所述多个单元室的一第一子集包括具有一第一刚性的第二部分,而且所述多个单元室的一第二子集包括具有第二刚性的第二部分,其中,所述第一刚性不同于所述第二刚性。
5.用于支持一通路的可膨胀的设备,所述可膨胀的设备具有一表面,所述表面由多个单元室(64)组成,每一单元室(64)具有一稳态的收缩构形(50)和一稳态的膨胀构形(60),所述稳态的膨胀构形(60)比所述稳态的收缩构形(50)包绕着一更大区域,每一单元室(64)包括第一和第二交联部分(66,68),所述第二交联部分(68)比所述第一交联部分(66)更柔软,所述可膨胀的设备的特征在于:当在所述稳态收缩构形(50)和相继的多个离散的稳态的膨胀构形之间转变时,所述多个单元室(64)经受弹性变形。
6.按权利要求5所述的可膨胀的设备,其特征在于:所述的多个单元室(64)中的每一个能够在所述稳态的收缩构形(50)和相继的多个所述稳态的膨胀构形(60)之间等温地转变。
7.按权利要求1所述的可膨胀的设备,其特征在于:所述多个单元室(64)构造并设置成使得所述单元室(64)可通过对所述可膨胀的设备(50,60)的一内表面施加一均匀的径向指向的力而在所述两稳态构形(50,60)间转变。
8.按权利要求5所述的可膨胀的设备,其特征在于:所述多个单元室(64)的每一个具有一均衡的中心位置,并具有一绕所述均衡的中心位置的不对称负载-位移特性,其中,所述膨胀构形(60)是每一单元室(64)的最稳定构形。
9.按权利要求5所述的可膨胀的设备,其特征在于:所述多个单元室(64)的每一个具有一均衡的中心位置,并具有一绕所述均衡的中心位置的不对称力-位移特性,其中,所述收缩构形(50)是每一单元室(64)的最稳定构形。
10.按权利要求5所述的可膨胀的设备,其特征在于:所述多个单元室的一第一子集包括具有一第一刚性的第二部分,而且所述多个单元室的一第二子集包括具有第二刚性的第二部分,其中,所述第一刚性不同于所述第二刚性。
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EP0961597A2 (en) 1999-12-08
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IL131063A0 (en) 2001-01-28
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CN1261262A (zh) 2000-07-26
AU746009B2 (en) 2002-04-11
JP5586517B2 (ja) 2014-09-10
WO1998032412A2 (en) 1998-07-30
KR20000070427A (ko) 2000-11-25
CN1172636C (zh) 2004-10-27
AU6038198A (en) 1998-08-18
US20110208291A1 (en) 2011-08-25
DE69831935T2 (de) 2006-07-27
US7828836B2 (en) 2010-11-09
US20150250580A1 (en) 2015-09-10
US20040193247A1 (en) 2004-09-30
CN1626048B (zh) 2012-09-12
JP2011167525A (ja) 2011-09-01
US9241782B2 (en) 2016-01-26
EP0961597B1 (en) 2005-10-19
US6488702B1 (en) 2002-12-03
CA2278640A1 (en) 1998-07-30
JP2001511030A (ja) 2001-08-07
JP2008119490A (ja) 2008-05-29
JP2013135930A (ja) 2013-07-11
JP5063335B2 (ja) 2012-10-31
JP4087905B2 (ja) 2008-05-21
SG161732A1 (en) 2010-06-29
EP1656892A3 (en) 2006-05-31
EP1656892A2 (en) 2006-05-17
EP0961597B8 (en) 2005-12-28
ATE306873T1 (de) 2005-11-15
US7758628B2 (en) 2010-07-20
IL131063A (en) 2005-07-25
ES2251763T3 (es) 2006-05-01

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