CN1255385A - 蛇形的梯绕扩张器 - Google Patents

蛇形的梯绕扩张器 Download PDF

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CN1255385A
CN1255385A CN99118499A CN99118499A CN1255385A CN 1255385 A CN1255385 A CN 1255385A CN 99118499 A CN99118499 A CN 99118499A CN 99118499 A CN99118499 A CN 99118499A CN 1255385 A CN1255385 A CN 1255385A
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dilator
bar
side bands
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knee
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J·里希特
G·平查斯克
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MEINOL Ltd
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Abstract

提供了一种蛇形梯绕扩张器,其中由一卷绕的网格条状物形成该扩张器,网格的侧面是蛇形的。这样该扩张器由螺旋式卷绕成一系列盘绕圈的条状物构成,其中条状物由至少两个用一系列横杆相互连接的侧带构成。各侧带成形为包括一系列弯曲处的蛇形,其中一旦扩张器扩张,侧带的弯曲处即张开以加长各网格沿螺旋方向的长度,因而使条状物沿螺旋方向变长以允许扩张器扩张而不会使条状物有任何显著的退绕。

Description

蛇形的梯绕扩张器
本发明通常涉及扩张器，该扩张器植入体内管腔如血管中，以便支承和保持管腔打开或固定和支承管腔内的其它假体。
在现有技术中已知各种扩张器。扩张器通常是管状的，并可从较小的未扩张的直径扩张到较大的扩张后直径。为便于植入，扩张器通常安装在导管的端部上，以其较小的未扩张的直径保持在导管上。通过导管，将未扩张的扩张器引导通过体腔到达欲植入的位置。一旦扩张器处于欲植入的位置，它即扩张，一般或是通过例如膨胀扩张器内侧上的一个气球产生的内力，或是通过允许扩张器自行扩张，如通过取出绕自扩张的扩张器的一个套筒，允许该扩张器向外扩张。在任一情况下，扩张后的扩张器均反抗管腔收窄的趋势，以保持管腔开放。
涉及扩张器的某些专利包括授予Maass等的美国专利4,553,545；授予Palmaz等的美国专利4,733,665；授予Gianturco的美国专利4,800,882和5,282,824；授予Hillstead的美国专利4,856,516、4,913,141、5,116,365和5,135,536；授予Wiktor的美国专利4,649,922、4,886,062、4,969,458和5,133,732；授予Pinchuk的美国专利5,019,090；授予Palmaz和Schatz的美国专利5,102,417；授予Wolff的美国专利5,104,404；授予Tower的美国专利5,161,547；授予Cardon等的美国专利5,383,892；授予Pinchasik等的美国专利5,449,373；和授予Israel等的美国专利5,733,303。
授予Maass等的美国专利4,553,545(“Maass′545号专利”)，其公开内容作为参考结合在本申请中，示出了螺旋弹簧形式的各种扩张器。该专利的图1至7示出了由螺旋式卷绕的线材形成的螺旋弹簧扩张器，其中通过转动弹簧端部来收缩和扩张扩张器的端部。这种螺旋弹簧扩张器是很柔软的，使得它们可容易地循曲折管腔进入并在植入后能较紧密地贴合管腔。但尽管这些扩张器是很柔软的，但它们在扩张后也难以提供稳定的支承。线圈中的单个的圈可相对于对方移动，有时在相邻的圈之间产生很大的间隙，此间隙会使相当部分的管腔壁得不到支承。此外，结圈中的圈可能略有弯曲或倾斜，潜在地阻碍和严重地损伤管腔。Maass的′545号专利中的图10示出了在这些螺旋弹簧扩张器中的倾斜的圈的一个例子。
Maass的′545号专利公开了设计来克服这些螺旋弹簧扩张器不稳定性的各种机构。例如，图11至14示出了利用呈轴向支承件形式的刚性化装置，该装置沿扩张器的一侧延伸并维持各圈的相对定位。图22示出了一个绕制的带材构成的扩张器，其中带材上有开口而使之取梯子的形状。图23示出了另一个梯绕扩张器，其中梯子是由两根用横向件相互连接的线材形成的。这些梯绕扩张器与单丝螺旋弹簧扩张器相比提供了改善的稳定性。
尽管这些改进，与Maass′545专利所公开的这些螺旋弹簧扩张器和梯绕扩张器相关的一个问题是扩张器的扩张导到扩张器退绕。这种退绕现象使得扩张器扭转，包括扩张器端部的转动，这对血管壁有潜在的危害。此外，扩张和扭转使得单个圈的数量减少，导致较少的圈去支承血管壁。圈数的减少也意味着：扩张器的长度明显缩短以维持圈与圈的间隔，或圈与圈之间的间隔明显增加以维持扩张器的长度，或在某些情况下上两种的组合。缩短导致地所设置的扩张器中对血管壁的长度方向覆盖率减小，以及设置期间可能损害血管壁的侧向力矩。圈与圈之间间隔的增加会导致血管壁的相当部分未受支承。以上两者是Maass的′545号专利所公开的螺旋弹簧和梯绕扩张器的潜在缺陷。
授予Wiktor的美国专利4,886,062和5,133,732(“WiRtor′062号专利”和“Wiktor的′732号专利”)，其公开内容作为参考结合在本文中，示出了一种由线材形成的扩张器，其中线材开始被成形为形成蛇形图案的锯齿状带，然后根据齿状带卷绕成一螺旋式扩张器。该扩张器由内力如膨胀一个气球来扩张。类似的卷绕锯齿状扩张器的另一例子是由Cordis Corporation上市的Grossflex扩张器。
在Wiktor′062和′732专利的图1至6中所示的卷绕锯齿状扩张器是很柔软的，但同样它们较不稳定。Wiktor′732号专利公开了这些卷绕锯齿状扩张器的另一种结构，以克服它们的不稳定性。在该专利的图7中所示的一个例子中，一根直的纵向线材沿扩张器的一侧延伸并连接于各圈上以相互固定它们。在该专利的图8中所示的另一个例子中，在绕扩张器的螺旋线的多个位置上，使锯齿线材上的一弯曲处比其它弯曲处长，这样它可到达和钩住在螺旋线的相邻圈上的一弯曲处。这些结构可增加扩张器的稳定性，但同时也降低了扩张器柔性。
本发明的一个目的是提供一种沿纵向具柔性的扩张器，使之可容易地进入弯曲管腔且在设置后不会明显改变管腔的顺从性，其中该扩张器较为稳定，这样它可避免弯曲或倾斜而潜在地阻塞管腔并且它可避免使血管的相当部分不受支承。
本发明的另一目的是提供一种扩张器，它在扩张时其端部没有或几乎没有扭转或转动，并在扩张时它也不会或几乎不会缩短，同时在扩张时也不会导致在扩张器相邻的圈之间形成明显的间隙。
根据本发明的一个实施例，一扩张器被构造为一卷绕的扩张器，其中该卷绕的扩张器由一卷绕的网格条状物形成。这样，该扩张器由螺旋式卷绕成一系列盘绕圈的条状物形成，其中条状物由至少两个例如用一系列横杆相互连接的侧带构成。各侧带成形为包括一系列弯曲处的蛇形，其中一旦扩张器扩张，侧带的弯曲处即张开以加长各网格沿螺旋方向的长度，因而使条状物沿螺旋方向变长以允许扩张器扩张而不会使条状物有任何显著的退绕。
根据本发明的蛇形梯绕扩张器保留了与螺旋弹簧式扩张器相关的柔性，但它的圈较稳定且不易位移和倾斜。这样根据本发明的蛇形梯绕扩张器为管腔组织提供了连续的支承，而不会阻碍管腔。
此外，蛇形梯张扩张器显著避免了在扩张器扩张时扭转，端部转动，缩短和产生较大间隔等现象。当蛇形梯绕扩张器扩张时，扩张器上的向外的径向力使蛇形侧带上的弯曲处张开并变直，因此使条状物的总长沿螺旋方向增加。通过提供一个在扩张器扩张时允许条状物本身沿螺旋线方向变长的蛇形条状物，扩张器在直径上的增加就可通过条状物的变长而非条状物退绕而容纳。这样，可保持圈的数量并可大为减少或避免端部转动，缩短或圈之间间隔张开的现象。事实上，可将蛇形梯绕扩张器构造为在扩张器扩张时在相邻的圈上的相邻点仍然相互邻近。这样在扩张器端部处的条状物两端可例如通过焊接连接于相应的相邻圈上，因而形成一平滑的端部并确保没有转动。
图1示出了现有技术中三个丝绕扩张器的示意图，第一个具有等距隔开的圈，第二个具有不均匀隔开的圈，第三个具有倾斜的圈；
图2示出了未扩张状态的带绕扩张器；
图3示出了图2所示的处于扩张状态的扩张器；
图4示出了现有技术的梯绕扩张器，与授予Maass等的美国专利4,553,545中所示和所描述的类似；
图5示出了根据本发明的处于扩张状态的蛇形梯绕扩张器；
图6示出了用以形成根据本发明的蛇形梯绕扩张器的条状物；以及
图7示出了根据本发明的处于未扩张状态的蛇形梯绕扩张器。
图1示意性地示出了三个现有技术扩张器的剖视图，它们均有一螺旋卷绕的金属丝构成。最上面的丝绕扩张器A处于最佳的理想的状态，每个圈1′与相邻的圈均匀地隔开。这样，相邻的圈1′之间的间隙2′是较为均匀的，这样如果如图所示圈1保持均匀地隔开，就可对血管壁提供较为均匀的支承。
但在实际中，图1所示的丝绕扩张器往往会改变构形，尤其是在植入期间和植入后当它承受血管中的各种应力时。这样某些圈往往会分开的较远，如图1中的中间的丝绕扩张器B。在中间的丝绕扩张器B中，圈1″不均匀地分开，有时会留下较大的间隙2″。
传统的丝绕扩张器的圈在血管内时也有可能弯曲或倾斜。图1中最下面的丝绕扩张器C中，某些圈1稍微倾斜。这些倾斜的圈不仅不能为血管提供支承，而且它们也进入并局部地妨碍通过扩张器的通道，这样就严重地危及人体管腔。
克服丝绕扩张器不稳定问题的一种方式是用带材替换金属丝，带材的宽度明显大于它的厚度。图2示出了安装在一导管15上的一个未扩张的带绕扩张器10。如图2所示，带绕扩张器成形为一个螺旋状卷绕的条带。如图2所示，由于在带绕扩张器10中带的宽度不大于图1所示的丝绕扩张器A中丝的宽度，所以带绕扩张器10的圈11更能抵抗纵向位移或倾斜。
图3示出了处于扩张状态的图2所示的带绕扩张器10。例如通过膨胀一个导管15上的气球16可实现扩张，气球16的向外的力作用在扩张器10的内侧并使扩张器10扩张。当带绕扩张器10如图3所示扩张时，单个圈11的直径增大。但是由于条带的长度是不变的，所以直径的增加就使条带有些退绕，以容纳扩张。在此过程中，扩张器10的端部13转动，圈11的数目减少，扩张器的总长度缩小和/或在相邻的圈11之间形成间隙。扩张器的转动，尤其是扩张器端部的转动对血管有潜在的损害，并且圈数减少及扩张器长度的减小或圈之间的间隙的张开会导致血管壁不能得到充分支承和不可预料的损伤覆盖区。
除了这些缺点，带绕扩张器10还有的缺点是条带的金属覆盖高百分比的受扩张血管壁的表面积。高百分比的金属覆盖率阻止或减缓了血管壁对扩张伤害的愈合反应。通过将条带改为梯形条状物可以解决带绕扩张器10中存在的高百分比金属覆盖率的问题，在此梯形条状物中盘绕成扩张器的条状物在其上有一系列开孔，如同一个梯子。图4示出了一例梯绕扩张器20，类似于授予Maass等的美国专利4,553,545所描述的现有技术梯绕扩张器。
在梯绕扩张器20中，该条状物具有由横杆26桥接的侧带24、25。侧带24、25和横杆26形成了一系列开孔27，其中各开孔27由两个侧带24、25和两个横杆26界定。类似于盘绕的丝和条带，梯形条状物螺旋地卷绕，形成一系列圈21。
梯绕扩张器20保留了与带绕扩张器10相关的刚性和稳定性，这是因为与条带的圈11一样，梯形条状物的单个的圈21与丝绕扩张器的单个的圈相比宽度已经增加。此外，由于开孔27，梯绕扩张器20与带绕扩张器10相比减小了金属覆盖面积，而不会损害对组织的支承。
但是，梯绕扩张器20仍然具有一些与丝绕和带绕扩张器相关的同样缺陷。最明显的是，梯形条状物一旦膨胀就会略有退绕，导致扩张器扭转以及扩张器端部23转动，和扩张器缩短或相邻圈之间的间隙明显张开。
图5示出了一个根据本发明构成的蛇形梯绕扩张器30。图5所示的蛇形梯绕扩张器30安装在导管15上，处于扩张状态。
图5所示的蛇形梯绕扩张器30被构成为一盘绕扩张器，其中由网格37构成的卷绕的条状物形成盘绕，这里网格37的侧面是蛇形的。这样，该扩张器就由一个螺旋形卷绕成一系列盘绕圈31的条状物构成，其中该条状物由两个彼此由例如一系列横杆36连接侧带34、35构成。每个侧带34、35均成形为蛇状形式，包括一系列的弯曲处38，其中在扩张器扩张时，侧带34、35的弯曲处38张开以沿螺旋方向增加各单个网格37的长度，因此沿螺旋方向加长了该条状物以允许扩张器30扩张而不会使该条有任何明显的退绕。在所示实施例中，侧带34、35中的弯曲处以周期性的模式存在。例如可以以正弦波的模式或以任何其它适当的构形设置弯曲处38。
在所示实施例中，相互连接侧带34、35的横杆36是直的并沿通常垂直于卷绕该条状物的螺旋方向的方向延伸。作为选择，横杆可以有一个或多个弯曲处，和/或它们可以以其它角度在两侧带之间延伸。在所示实施例中，横杆36连接在侧带34、35上的相互对置的弯曲处38，并且它们在每两个弯曲处38的位置连接于侧带34、35。作为选择，横杆36也可以连接在其它地方，并且可以以或多或少的频率存在，而不脱离本发明的总构思。作为选择，扩张器也可不用横杆36，而可在相邻的点处使两蛇形侧带34、35周期性地相互连接。
如图5所示，可使蛇形梯状的条状物的端部33渐缩。使该条状物的端部33渐缩以允许成品扩张器的端部是直的，即它允许该扩张器取正圆柱体的形式，圆柱体扩张器的各端部处在垂直于扩张器纵轴线的平面内。通过例如焊接可将该条状物的端部33连接于相应的相邻的圈31。
图6示出了一用以形成根据本发明的蛇形梯绕扩张器的条40。条状物40有通过横杆46连接的蛇形侧带44、45。使条40在其端部渐缩，以使蛇形侧带44、45在端部43处收敛。
图7示出了一个根据本发明的蛇形梯绕扩张器50，处于未扩张的状态。如图7所示，渐缩的端部43可连接在相应的相邻圈上。
如图5所示，当蛇形梯绕扩张器被扩张时，扩张器上向外的径向力使得蛇形侧带34、35上的弯曲处38张开，从而使网格37的长度沿螺旋方向增加。该条状物的可扩张网格的这一特征允许条状物的总长度沿螺旋方向增加。通过在扩张器扩张时使该条状物本身沿螺旋方向变长，就容纳了扩张器直径的增加，而不必退绕该条状物。以这种方式，可保持圈31的数目，并避免端部33转动。事实上，由于端部33不转动，所以可以如上所述将它们焊接在相应的相邻圈31上，从而形成一平滑的端部。可以类似地焊接扩张器圈31上的其它相邻的点，以增加扩张器的稳定性，而不牺牲柔性。
根据本发明的蛇形梯绕扩张器保留了与丝绕扩张器相关的柔性，但避免了与这些扩张器相关的一些问题。蛇形梯绕扩张器的圈相对较稳定且不易位移或倾斜，这一问题不仅与Maass的′545专利公开的直的单带绕制扩张器相关，而且与例如在Wiktor′062和′732专利公开的蛇形的单带绕制扩张器及Cordis Crossflex扩张器相关。此外，根据本发明的蛇形梯绕扩张器对血管组织提供了连续的支承，而不存在有害的高百分比金属覆盖率。由于制造扩张器的条状物在长度上可沿螺旋方向扩张，所以扩张时该条状物可以变长而容纳扩大的直径，因此明显避免了端部转动以及扩张时圈与圈之间的间隙变小或张开的问题。
用以构成蛇形梯绕扩张器的条状物可以例如由线状金属或扁平金属制成。当用扁平金属时，例如可以通过激光切割或化学蚀刻来形成该条中的花纹。也可如此制造扩张器：首先制造条状物，然后螺旋式卷绕该条状物以形成扩张器，然后如果需要将条状物的端部焊接在相邻的圈上。作为选择，可如此形成扩张器：通过激光切割或化学蚀刻在管件上直接形成所需花纹，或者通过激光切割或化学蚀刻在一扁平片材上形成所需的花纹，然后将此扁平片材卷绕成一管件并例如通过焊接连接边缘。可以采用本领域中所知的其它任何适当制造方法制造根据本发明的扩张器。
这里所述的实施例仅是举例而已，其它变动均在权利要求书所限定的本发明的范围内。

Claims (14)

1.一种扩张器，由螺旋式卷绕成一系列盘绕圈的条状物构成，其中该条状物具有至少两个侧带，其中至少两个侧带中的每一个均成形为包括一系列弯曲处的蛇状形式，其中该条状物的至少两个侧带被相互连接，并且其中一旦扩张器扩张，至少两个侧带的弯曲处就张开以便沿螺旋方向加长条状物，从而允许扩张器扩张而不使该条状物有任何明显的退绕。
2.如权利要求1所述的扩张器，其中至少两个蛇形的侧带由横杆相互连接。
3.如权利要求2所述的扩张器，其中横杆连接至少两个蛇形侧带上的相邻的弯曲处。
4.如权利要求3所述的扩张器，其中由各横杆连接的相邻的弯曲处沿相反的方向面对。
5.如权利要求3所述的扩张器，其中横杆以周期性的间隔连接至少两个蛇形侧带，并且其中至少两个蛇形侧带中的每一个在相继的横杆之间具有至少一个弯曲处。
6.如权利要求2所述的扩张器，其中所述横杆是直的。
7.如权利要求2所述的扩张器，其中所述横杆有弯曲处。
8.如权利要求2所述的扩张器，其中横杆通常垂直于卷绕条状物的螺旋方向延伸。
9.如权利要求1所述的扩张器，其中条状物有两个端部，其中至少两个侧带在条状物的两端朝对方收敛，使得条状物的两端渐缩。
10.如权利要求1所述的扩张器，其中条状物有两个端部，条状物的第一端部位于扩张器的第一端，条状物的第二端部位于扩张器的第二端，并且其中条状物的各端均连接于扩张器的一相邻圈上。
11.如权利要求10所述的扩张器，其中条状物的各端均通过焊接连接于该相邻圈上。
12.如权利要求1所述的扩张器，其中条状物由线材制成。
13.如权利要求1所述的扩张器，其中条状物由扁平金属制成。
14.如权利要求1所述的扩张器，其中通过制造该条状物然后螺旋式卷绕该条状物成扩张器来制造该扩张器。
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