CN1314193A - 用于覆盖-斯坦特固定模的方法和器件 - Google Patents
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Abstract
一适于植入到管腔中的可扩张斯坦特固定模被生物材料覆盖。在一实施例中,生物纤维被交织缠绕以形成固定模覆盖物。这些纤维被配置得相对固定模的纵轴线有一角度,以当固定模扩张时所述角度也增加。在另一个实施例中,固定模处于压缩时,条状心包膜被螺旋形缠绕在支撑固定模上。当该固定模扩张时,该条带松懈,但保持完全盖住固定模。还可在心包膜条上形成互锁边缘,以保持完全盖住这个固定模。
Description
本发明总的涉及用于植入到一活体内的斯坦特固定模。本发明特别涉及到一种用于斯坦特固定模的生物覆盖物,这种斯坦特固定模适于植入到各种管腔内。
为了防止再变窄现象,在冠状或周围血管内被永久性植入金属的脉管固定模。这些斯坦特固定模典型的是通过导管在管腔内被输送到所需部位,并在那里扩张定位,以支撑一动脉的病变部位。
这些传统的斯坦特固定模的一个缺点是:即使在斯坦特固定模植入后,仍然会发生再变窄现象。另一个缺点是在植入斯坦特固定模期间,这个斯坦特固定模可能引起质粒通过敞开的单元(cell)从动脉腔壁中排出。这些排放的质粒可能在血流中形成栓子,引起严重的后果。
为了减少这些问题,已经有建议在斯坦特固定模上使用覆盖物。这些覆盖物是用诸如PTFE等人造材料制成的。然而,到目前为止,由人造材料制成的覆盖物还没有证明成功。这可能是由于这样的材料之生物适配性太差的缘故。
还有一些经验是使用诸如牛的心包膜一类生物材料构造斯坦特固定模的覆盖物,这种的生物适配性远远高于由人造材料构成的覆盖模。从生物适配性的角度考虑,使用牛的心包膜的初步结果令人鼓舞。
然而,这种现行的使用生物组织构建覆盖物的方法过分简易。从供牛上取下一块矩形的心包膜。然后,在将该心包膜修整成适于植入的形状后,被卷成圆筒形。将该心包膜的相邻的边缘缝合到一起形成一个覆盖物。然后将这个覆盖物设置到一斯坦特固定模上。
这种切割和缝合以创建覆盖物的方法有一个固有缺点。生物组织的扩张范围很小。因此,这个被切割并缝合的圆筒形组织的直径被限定在很小的范围内。这限制了斯坦特固定模在一很小的扩张直径范围,也就限制了它的使用。这也限制了斯坦特固定模在被传送状态和它的扩张状态的之间直径的差异,同时对于一给定的支撑直径,明显增加了需要的传送系统的断面。
在本发明的一个实施例中,用生物纤维或可生物降解的纤维或纤维束被配置为交织缠绕的线结构以形成可扩张的管件。该交织缠绕的线结构被配置为:在斯坦特固定模没有扩张的情况下,交织缠绕的线结构之间成一锐角。当斯坦特固定模扩张时,交织缠绕的线之间的角度增加。这样就允许这种斯坦特固定模覆盖物以各种直径扩张。
在另一个实施例中,一心包膜条被螺旋形缠绕在一斯坦特固定模上,在斯坦特固定模处于第一种状态,即不扩张的直径时,相邻的(条带)绕圈之间为基本上搭叠状态。在扩张到第二扩张直径时,这些心包膜条将在斯坦特固定模上滑动并松懈成数量较少的环圈,但仍然完全覆盖住这个斯坦特固定模。在这个实施例的另外加强变型中,这些螺旋形线(绕,环)圈的边缘被形成锁定折迭,以防止在斯坦特固定模和覆盖物扩张期间,这些螺旋环圈分离。
因此,本发明的一个目的是提供一种改良的用于斯坦特固定模的生物组织覆盖物,以及产生这种覆盖物的方法。
从以下对公开的发明的详细描述中,本发明的其它目标和优点,对于那些本领域的熟练人员将会很清楚。
图1显示一个在未扩张状态下的交织的斯坦特(stent)固定模覆盖物。
图2显示一个在扩张状态下的交织的斯坦特固定模覆盖物。
图3显示用于形成斯坦特固定模覆盖物的条状的心包膜。
图4显示处于未扩张状态下的螺旋状缠绕的斯坦特固定模覆盖物。
图5显示处于扩张状态下的螺旋状缠绕的斯坦特固定模覆盖物。
图6显示处于未扩张状态下的螺旋状缠绕的斯坦特固定模覆盖物的部分截面图。
图7显示处于扩张状态下的螺旋状缠绕的斯坦特固定模覆盖物的部分截面图。
上述的发明将参考本发明的特别的优选实施例进行详细描述,应该明白这些实施例仅仅是作为一种示例的目的,本发明并不仅限于此。
图1和图2显示根据本发明进行的内用假体的示意图。一个鲁米那(luminal)内用假体20有一个管状的斯坦特固定模22,它可以从图1显示的第一直径D扩张到图2显示的第二直径D’。斯坦特固定模1可以是一种自身扩张的固定模或气囊(balloon)扩张的固定模。美国专利申请号5,807,404说明了一个适当的气囊扩张的斯坦特固定模的例子,它的公开内容通过引证结合于此。
这个斯坦特固定模有一个由生物纤维构成的覆盖物24。这种生物纤维可以通过溶解任何适当的生物组织,诸如牛,羊或猪的心包膜组织获得。另外,这种纤维也可以用其它材料诸如Cut-Gut胶原纤维形成。
如图1所示,单个纤维26被交织缠绕,并相对斯坦特固定模22的纵轴线30形成一个角度28。当该斯坦特固定模处于不扩张直径D时,角度28大约是30°。
典型的,该内用假体将通过传统的气囊(balloon)血管成形术植入。在这个手术中,斯坦特固定模22和与之相连的覆盖物24被安置在一气囊导管之末端的气囊上,并被输送到一动脉的狭窄的或病变的部位。然后通过给气囊充气使斯坦特固定模和覆盖物扩张,以接触到管壁。然后可使导管放气并撤出,将斯坦特固定模和覆盖物留在治疗部位。如图2所示,由于从第一直径D扩张到第二直径D’,可扩张覆盖物的纤维则改变方向,从而使它们相对斯坦特固定模20的纵轴线形成较大的角度28,这个角度大于在第一直径D的情况下的角度。在扩张后直径D’下的角度28根据斯坦特固定模的扩张量来定。因此,根据斯坦特固定模被插入的管腔的大小,角度28可从30°变化到90°。
图3-5显示了生物斯坦特固定模覆盖物的另一个实施例。在这个实施例中,心包膜组织以本领域的熟练人员所熟知的方式收集和制备。然后该心包膜组织被切成具有侧缘52的单条50。提供一个具有未扩张直径D和扩张直径D’的支撑斯坦特固定模54。当该支撑斯坦特固定模在直径为D的收缩状态下,将条带50螺旋形缠绕到支撑物斯坦特固定模54上,形成一系列螺旋形线圈56。相邻螺旋形线圈56的侧缘52被安置成这样,使得一个线圈的侧缘52搭叠在相邻的那个线圈上。
在从直径D扩张到直径D’的情况下,螺旋形缠绕的心包膜条带将松解。但是,由于在相邻的条带之间有搭叠,所以在斯坦特固定模和覆盖物扩张期间和扩张后,斯坦特固定模上没有未被覆盖的区域。在无间隙地最大扩张的直径与未扩张的斯坦特固定模之直径间的比率等于该斯坦特固定模的所述搭叠比率。
图6和7显示了螺旋形缠绕的斯坦特固定模的另一个实施例。在这个实施例中,心包膜条50的边缘52设有互锁边缘64,62。通过折叠该心包膜条的边缘于自身上形成右边的互锁边缘62。再通过折叠该心包膜条的边缘于自身上形成左边的互锁边缘64;该左缘折叠的方向与右缘的方向相反。
具有互锁边缘的条带以根据前面图4和5所示的实施例所描述的相同的方式,被螺旋形地缠绕到斯坦特固定模上。要特别注意,以保证将右互锁边缘62置于右缘66和相邻的螺线缠绕的左互锁边缘64之间。在斯坦特固定模扩张期间,右和左互锁边缘配合到一起。以这种方式,如图7所示,互锁边缘保证了在扩张后的斯坦特固定模的覆盖物上没有间隙。
Claims (14)
1.一个被覆盖的斯坦特固定模包括:
一具有一纵向轴线的可扩张的斯坦特固定模,该斯坦特固定模可以从第一直径扩张到第二直径;
一个附加到该斯坦特固定模上的覆盖物,这个覆盖物由生物材料的线状纤维构成,其中,在第一直径中,该生物纤维相对该斯坦特固定模的纵轴线形成第一角度,在第二直径中,该生物纤维相对该斯坦特固定模的纵轴线形成第二角度。
2.按照权利要求1的斯坦特固定模,其特征在于第一角度约等于30°。
3.按照权利要求1的斯坦特固定模,其特征在于第二角度依赖于斯坦特固定模的扩张量。
4.按照权利要求1的斯坦特固定模,其特征在于生物材料选自的种类包括:牛的心包膜,羊的心胞膜,猪的心包膜。
5.按照权利要求1的斯坦特固定模,其特征在于线性纤维形成于胶原纤维。
6.一种覆盖一斯坦特固定模的方法包括步骤如下:
提供心包膜组织;
提供一个带纵向轴线的可扩张的斯坦特固定模,该斯坦特固定模可以从第一直径扩张到第二直径;
溶解该心包膜组织成为纤维束;
使该纤维束交织缠绕成为圆筒形覆盖物,从而使在第一直径状态下,该交织缠绕的纤维束相对斯坦特固定模的纵轴线呈一个角度定位,当处于第一直径时,该角度大小于约45度;
在斯坦特固定模处于第一直径时,将该覆盖物附加到斯坦特固定模上。
7.一种制造管腔内斯坦特固定模的方法包括步骤如下:
提供一具有第一直径和第二直径的斯坦特固定模;
提供一具有侧缘的心包膜条带;
当斯坦特固定模处于它的第一直径时,使该心包膜条螺旋形缠绕到斯坦特固定模上,从而使相邻的线圈(条带绕圈)的侧缘搭叠。
8.按照权利要求7的方法,其特征在于,还包括折叠心包膜以形成锁定边缘的步骤。
9.按照权利要求7的方法,其特征在于该心包膜组织选自的种类包括:牛的心包膜,羊的心胞膜,猪的心包膜。
10.一个管腔内斯坦特固定模,包括
一个管状的支撑件;该件可以从第一直径扩张到第二直径;
一个被施加到该管状支撑件上的可扩张的覆盖物,该可扩张的覆盖物由生物材料构成的线状纤维制成,该纤维被这样配置,以使得在第一直径时,这些纤维相对该管状支撑件的纵轴线的角度小于45度。
11.按照权利要求10的斯坦特固定模,其特征在于该线状纤维是胶原纤维。
12.按照权利要求10的斯坦特固定模,其特征在于该线状纤维是心包膜纤维。
13.一个管腔内斯坦特固定模,包括
一个管状的支撑件;该件可以从第一直径扩张到第二直径;
一个被施加到该管状支撑件上的可扩张的覆盖物,该可扩张的覆盖物由条状的心包膜被螺旋状缠绕到该管状支撑件上构成,这个条带具有侧缘,该侧缘在第一直径时互相搭叠。
14.按照权利要求13的管腔内斯坦特固定模,其特征在于该心包膜条具有锁定的边缘。
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US09/532653 | 2000-03-22 | ||
US09/532,653 US6736838B1 (en) | 2000-03-22 | 2000-03-22 | Method and apparatus for covering a stent |
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CN1314193A true CN1314193A (zh) | 2001-09-26 |
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US (2) | US6736838B1 (zh) |
EP (1) | EP1138278B1 (zh) |
JP (1) | JP2001259042A (zh) |
KR (1) | KR100400882B1 (zh) |
CN (1) | CN1314193A (zh) |
AR (1) | AR025505A1 (zh) |
AT (1) | ATE299360T1 (zh) |
AU (2) | AU767745B2 (zh) |
BR (1) | BR0100142A (zh) |
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DE (2) | DE60111882T2 (zh) |
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HK (1) | HK1038303A1 (zh) |
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2000
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- 2001-02-12 DE DE10106376A patent/DE10106376B4/de not_active Expired - Fee Related
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CN102573709A (zh) * | 2009-07-15 | 2012-07-11 | 戈尔企业控股股份有限公司 | 具有反颈缩性质的管子 |
CN102573709B (zh) * | 2009-07-15 | 2014-08-20 | 戈尔企业控股股份有限公司 | 具有反颈缩性质的管子 |
CN107072665A (zh) * | 2014-10-16 | 2017-08-18 | 波士顿科学国际有限公司 | 缠绕纤维的芯棒 |
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