CN113518599A - 血管内假体 - Google Patents
血管内假体 Download PDFInfo
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- CN113518599A CN113518599A CN202080017269.4A CN202080017269A CN113518599A CN 113518599 A CN113518599 A CN 113518599A CN 202080017269 A CN202080017269 A CN 202080017269A CN 113518599 A CN113518599 A CN 113518599A
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- stent graft
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Abstract
所述血管内假体(1)由管状针织织物结构制成,其在所述针织织物结构的网孔内集成至少一根螺旋状连续纬纱(3),其沿着血管内假体的整个主外形尺寸延伸。所述至少一根纱线(3)由形状记忆合金形成,其先前已经经过这种处理、并且尤其是这种热机械处理,使得在人体温度下,该纱线通过超弹性或形状记忆的作用赋予结构其管状形状。
Description
技术领域
本发明涉及血管内假体或支架移植物领域,更具体地旨在在主动脉瘤的情况下实施。
本发明更具体地针对将管状织物结构和形状记忆合金类型的至少一个丝状元件集成在一起的这种血管支架移植物。
背景技术
动脉瘤是动脉区段的扩张。这个病态区域的破裂很可能导致出血,有时是致命的。当检测到这种动脉瘤时,医学界可能会实施两种解决方案:第一种解决方案包括通过开放手术、即通过特别严重和侵入性的技术再吸收(resorb)该动脉瘤。第二种解决方案包括通过在动脉瘤的水平处插入支架移植物来对所述动脉瘤分流,支架移植物被植入相关动脉内的所述动脉瘤的上游和下游;然后谈到血管内手术。该分流管(shunt)旨在允许血流在支架移植物内的循环,并且必然引起所述动脉瘤内的血压降低,并且因此降低其破裂的风险。这第二种解决方案的优点主要是显著减少了实际手术。
这种支架移植物通常由与外骨骼相关联的织物主体形成,外骨骼通常由钢或金属合金制成并且有利地具有超弹性或形状记忆特性。该外骨骼经常被缝合到由织物材料制成的主体上或在相关领域中被称为静电纺丝的操作中与支架移植物相关联。由织物材料制成的主体例如由PET(聚对苯二甲酸乙二醇酯)制成。
形状记忆材料现在已广为人知并被广泛使用。它们具有能够以可逆的方式达到相对显著的变形水平的特性。这种现象是由于材料受到机械载荷(应力)和/或温度变化时材料内的晶体相变造成的。因此,形状记忆材料能够产生几种特别有利的特性,例如超弹性和铁弹性(形状记忆)。特别地,在形状记忆合金中已知基于镍和钛、例如已知商品名为镍钛诺的那些形状记忆合金。
因此,例如在文献US 6,814,747中已经描述了这种支架移植物,其包括织物管状护套,在其外部或多或少周期性地添加由形状记忆合金制成的环,其可能在温度的作用下、并且在典型的例子中通常在人体温度的作用下膨胀,以这样的方式使支架移植物具有确保其分流功能所需的管状形状,并且必然使支架移植物具有足够小的形状以允许其例如经由导管引入相关的动脉中。
虽然毫无疑问,这种类型的支架移植物在通过血管内手术治疗动脉瘤方面取得了显著进展,但它也存在许多缺点。
其中,首先可以提到内漏的情况,即所安装的支架移植物不密封。除了所述护套上形状记忆合金外骨骼的缝合区域外,这些内漏是通常通过编织形成的管状护套的实际结构所固有的,其很有可能在管状护套的水平处产生薄弱区域,并且必然产生血流由此可能通过其流出的孔口。虽然毫无疑问,这种类型的支架移植物在通过血管内手术治疗动脉瘤方面取得了显著进展,但它也存在许多缺点。当这种支架移植物例如被植入特别是腹主动脉的水平处,并且当该水平处的血流压力已知时,这些泄漏可能迅速成为问题,并且尤其是不允许再吸收支架移植物经过精确设计以减少其的动脉瘤。
使用现有技术的支架移植物的另一个固有困难在于在褶皱的水平处的错误定位和不令人满意的性能,该褶皱是指,支架移植物为了适应动脉在支架移植物旨在被植入的水平处的特定迂回曲折而可能采取的弯曲。支架移植物的这种褶皱很可能导致其至少部分阻塞,导致需要新的外科手术的严重并发症。
现有技术的支架移植物导致的另一个困难在于它们的异质性。确实,由于缝合线或环紧固模式或类似系统,并且通常由于织物结构上的外骨骼,支架移植物具有偏离天然组织的机械性能,这或多或少导致了对支架移植物的快速排斥,由于可能出现新的阻塞风险并且在再吸收动脉瘤的恰当的例子中可能不会产生期望的效果而需要定期更换。此外,现有技术的支架移植物结构的异质性可能导致所述结构在动脉内的可能的滑动(迁移),这不可避免地导致需要进行第二次高侵入性的手术。
发明内容
本发明的目的在于提供一种旨在克服这些不同缺点的血管内支架移植物。
因此,其目的在于提供一种血管内支架移植物,其由管状针织织物结构形成,在所述针织织物结构的网孔内集成至少一根螺旋状连续纬纱,其沿着支架移植物的整个主要外形尺寸延伸,所述至少一根纱线由先前已经经过这种处理(education)、特别是这种热机械处理的形状记忆合金制成,以赋予其超弹性特性或在由人体温度引起的奥氏体转变期间使得所述纱线赋予该结构其管状形状。
换言之,本发明包括将任何形式的外骨骼和其可能的缝合线抑制到现有技术的织物结构上,为支架移植物提供最佳均质性,并且由于针织织物结构的针脚的优化以及由于纬纱的热机械性能优化发展出尽可能成功的仿生性能。
由于在针织织物结构内、更准确地说在针织织物结构的网孔内集成了连续形状记忆合金纱线,因此一旦支架移植物处于平面内,针织织物结构提供期望的管状形状,以允许它履行其主要功能,即允许血液穿过其循环流动。
根据本发明,根据查米尤斯丝缎(Charmeuse)编织或其他类似的双面针织、纬链类型或能够使植入的结构获得良好的仿生特性的任何其他编织,并且根据期望的机械特性,特别是弹性、延展性或其他性能,在双针床Rachel织机或钩织机上获得针织织物结构。
应当进一步说明,由于所实施的针织机的电子控制,可以在制造过程中改变编织,例如包括具有不同密度或特性的区域。
所讨论的织物结构基于PET(聚对苯二甲酸乙二醇酯)或任何其他生物相容的(例如聚丙烯、ePTFE-膨体聚四氟乙烯)和/或可再吸收或可生物降解的(例如PGA-聚乙醇酸类型)聚合物纱线制成。
由形状记忆材料并且有利地由Ni-Ti制成的纬纱连续地被插入到所述针织织物结构的网孔中,以在生产方向上插入错开的方式在双针床的水平处进行插入,该连续纬纱通过围绕后者转动而被传送到两个针床的水平处,并且因此与由在两个针床的水平处的针织引起的两个织物层的形成同时进行。Ni-Ti编织的目的首先是确保在血管内手术期间支架移植物的主要功能,尤其是对动脉瘤内结构的最佳部署。
因此这可以引起纬纱的螺旋配置。因此,金属骨骼直接连续地、特别是以同质的并且没有缝合的方式集成在织物结构内,这与现有技术的支架移植物(其具有通常缝合到织物上、然后导致异质结构的外骨骼)相反。
根据本发明,通常由镍钛合金制成的纬纱本身可以在其插入双针床之前先行形成波纹。纬纱的这种特定波纹,其幅度和节距在所述纱线的特定热处理期间受到控制和强制给予,能够为结构提供更大的灵活性,并有助于使所述结构能够插入其导管以进行原位植入所必需的最终卷曲阶段。
由镍钛合金制成的纬纱具有50至200微米范围内的直径。如果纱线直径确实小于50微米,经验证明其提供给纱线的主要功能(即在奥氏体转变后使支架移植物具有管状形状)是不够的,并且很可能会出现阻塞的风险。
然而,如果形成纬纱的纱线直径大于200微米,则支架移植物变得太硬,并且其性能与期望的仿生性能差异太大,可能导致支架移植物在其被引入的动脉内迁移的风险,并且必然导致泄漏的风险。
根据本发明的另一个特征,支架移植物的纵向、即沿着其主要外形尺寸的变形在0至30%的范围内。该变形可能被证明对于保持接近仿生性能、并且因此对于最佳和均匀的流动而言是必需的,还降低了动脉其他区域受到干扰的风险。这是唯一能够进行这种抗伸长性调整的针织织物结构所固有的。
根据本发明的一个有利特征,支架移植物一旦形成就经过机械作用对其壁进行压实,然后涂上特定的表面涂层(主要由胶原、白蛋白或明胶形成,有利地用结构的生物相容性所需的组分,例如肝素、碳或含氟聚合物完成该涂层溶液),以赋予所述支架移植物关于血流粘度所需的渗透率水平,并且因此必然能避免泄漏,根据ISO 25539-2标准确定的渗透率通常接近0.1毫升/平方厘米/分钟。
本发明的目的还在于提供一种形成该血管内支架移植物的方法。该方法包括:
在双针床织机上通过经编针织形成两层,其在生产方向上在各自边缘的水平处连接在一起,以最终限定管状结构;
在双针床的水平处插入由形状记忆纱线制成的连续纬纱,在生产方向上错开地插入所述两层的网孔中,连续纬纱通过围绕所述针床转动、通常相对于结构的生产方向呈螺旋状地被传送到针床的水平处。
根据本发明的一个有利特征,螺旋的节距是恒定的,并且为了获得所需的密实度并优化支架移植物的密封,该节距为1/1,即每缝一针,由形状记忆材料制成的纬纱就围绕织物结构转动一次。然而,根据期望的特性,该节距可以是从1/2至1/10。
附图说明
在以下非限制性描述中将结合附图详细讨论本发明的上述和其他特征和优点,其中:
图1是示出植入腹主动脉内的根据本发明的支架移植物的简化视图。
图2是根据本发明的两种类型的支架移植物的简化视图,分别示出了等径支架移植物(左手部分)和设有在制造期间直接获得的分支(limb)的支架移植物(右手部分),并且两种类型的支架移植物可以在植入患者期间进行组装。
图3是在双针床织机上形成支架移植物的阶段中的根据本发明的支架移植物的简化视图,示出了具有超弹性特性的纬纱。
图4是图3的细节的简化图。
图5是通过形成本发明的支架移植物的方法实施的原理的顶视图的简化图。
图6是双针床的顶视图的简化图,示出了在所述针床的水平处插入形成圈的形状记忆纬纱。
图7是能够实施本发明的方法的装置的简化透视图。
具体实施方式
已经结合图1示意性地描述了根据本发明的支架移植物(a stent graft)(1)在腹主动脉(2)内的植入。为了图示的简单起见,仅示出了由形状记忆合金制成的连续纬纱(3),并且在恰当的例子中示出了例如镍钛诺的镍钛合金。可以很好地观察到由所述支架的实施例得出的其螺旋行程,此外,在下文中对其进一步详细描述。
在本示例中,旨在对动脉瘤(4)分流(shunt)的主支架移植物在接合区域(5)的水平处分成两个次支架移植物(6、7),其旨在被植入在两条股动脉(8、9)的起点中。
支架移植物的上部区域附接在主动脉弓的水平处。在恰当的例子中,经验证明了,至主动脉颈的附接区域(10)应当相对于结构主体进行加固,以便在结构植入体内之后避免任何迁移的风险。因此,在所述区域中,镍钛纬纱可以具有不同的直径或热机械性能以确保保持支架移植物。
图3示意性地示出了,根据本发明的支架移植物形成在具有网孔纱条(13)和连续镍钛合金纬纱(14)的Rachel织机的两个针床(11、12)上。连续镍钛合金纬纱(14)交替通过两个针床中的每一个,同时通过旋转装置(参见图5和7)集成到每侧的网孔(针(15)和导向器(16))中,通过停止所述旋转装置使节距为1/1或从1/2到1/10。纬纱(14)围绕两个针床的旋转已用箭头表示。
图4示出了图3的细节。更确切地说,已经示意性地示出了针床内的网孔。因此出现了形成结构的并且例如由网孔围绕纬纱(14)的PET制成的纱线(17)。
该实施例还能够通过下述情况简化,即在制造周期期间对最终由3D织物结构限定的管的宽度进行编程以形成主动脉瘤假体的分支或次支架移植物(6、7)之一,旨在插入一条或两条股动脉(见图2)。
根据该特定实施例(图2、右手部分),第二分支(6、7)根据小于对应于主支架移植物的直径的直径单独形成在针织机上。该组件是在植入期间根据符合支架移植物要求的模式通过互锁和附接而形成的。
不同部分(3、6和7)之间的接合区域(5)根据针对期望的构造的几何结构通过针织、编织或任何其他组装方式形成,并且能够连续地联接整个结构。
该次支架移植物经由第二导管在原位引入,正如通常对支架移植物的处理那样。在该情况下,在植入期间,最窄的部分钩住从导管出来处的第一部分。分支直径略大于接收它的部分的直径,这使其能够对第一部分施加足够的作用力以保证其在体内维持。根据需要,可以添加额外的钩以排除不同部分滑动或分离的任何风险。
该支架移植物的原位植入是经由一个或多个导管进行的,其中插入有所述支架移植物。该插入通常与形成所述支架移植物的3D结构的卷曲步骤连续。一旦后者就位,在腹主动脉内的恰当的例子中,镍钛纬纱的超弹性导致结构返回(在卷曲以允许其插入导管后)到其初始形状,并且特别是管状,以使得所述支架移植物能够实现赋予给它的功能,并且更特别地允许血流通过并且必然解决动脉瘤。
已经结合图5示出了形成本发明的支架移植物的方法的原理。基本上,3D结构是经由Rachel织机或双针床钩织机(20)产生的(为此,为了简化理解,未显示纱线供应模块)。
(沿箭头G的方向)围绕该双针床织机旋转用于供应由镍钛合金制成的纬纱(22)的线圈(21),其之前为了优化其热机械性能已经经过热处理并且被组装在支撑架(23)上。从而纬纱因此在组装在RACHEL织机的针床上的针(24)和导向器(25)的水平处沿着在该水平处3D结构的形成进行编织。
出于此目的,纬纱供应线圈(21)配置在与垂直于接收双针床的平面内切的平面中,并且穿过在所述针床的针和导向器的协作区域的水平处。
线圈围绕两个针床的旋转运动可以通过任何方式并且在任何情况下通过与在双针床织机上形成3D结构的针脚的周期同步的机构来获得。该线圈在通过制动装置(26)之后输送纬纱以确保纬纱的正确张力。该制动要么直接在纬纱上进行,要么在当前的线圈上进行。这种制动系统本身是已知的。它们尤其可以具有机械、电或甚至电磁性质。
可以与3D背景结构的针织程序同时直接管理纬纱相对于3D结构的生产方向所遵循的螺旋节距的编程。通常,该编程使得渗透率接近0.1毫升/平方厘米/分钟,在所有情况下都符合适用于所述确定的3D结构的标准,并且特别地能够实现其最适合容纳旨在其中运送的血流的密封功能,并且其在浸渍或涂层后可得。
由3D结构得出的管的直径通常为20毫米。然而,根据患者和支架移植物的应用区域,该直径可能在5毫米和40毫米之间变化,特别是当代替物或内部加固件似乎是必要的时,该支架移植物的用途不仅限于主动脉瘤,而且还用于其他血管病变。
此外,确定纬纱的螺旋节距,使得所述纬纱为了每个部件网孔、或其的每2至10个网孔(通常具有大约7至20个网孔/厘米的网孔密度)围绕管状织物结构转动一次。因此形成的结构能够确保最佳的热机械性能,并且在支架移植物已经被引入病态动脉部分内之后能够避免褶皱、内漏和迁移的风险。
因此,已经在图6中以顶视图示意性地示出了双针床。因此,正如图7所示,前(F1)和后(F2)针床以及经由装置插入纬纱的示意性布局已经成形,在该针床的水平处出现3D支撑结构的针织纱线(27)。
这种装置通常包括用于供应纬纱(22)的线圈(21),其组装在圆环(28)上。因此,该圆环围绕双针床织机组装。它例如经由被电动机(未示出)旋转的齿轮(29)旋转。这种齿轮啮合在所述环的带齿外围边缘(30)上。可以使用皮带驱动系统或任何其他驱动装置来确保旋转。致动齿轮的电动机的管理与双针床织机的操作周期同步,以在正确的时间在每个针床的水平处引入纬纱。
因此,当通过组装在针床上的针织构件(分别为针和导向器)的作用而获得的3D织物结构形成时,纬纱围绕该区域中的针床进行转动(revolution),并且在该示例中旋转一次。根据保留的纱线联接程序,导向器本身在支撑杆(31)上移动。
正如也在该图中所示,制动装置(32)位于线圈输出端,用于调节纬纱的张力。
根据本发明并且在支架移植物形成之后,用例如胶原的溶液对其进行全浴涂覆。这优化了根据适用于支架移植物的ISO25539-2标准测量的渗透率水平,结果证明这是足够的并且满足了现行要求。这种涂覆也可以通过其他可用的技术进行,例如通过溅射。
因此,本发明的支架移植物的价值是显而易见的。首先,应当强调它的仿生特性,其一方面来自于它的同质结构和它的抑制了任何外骨骼和缝合线的概念(notion)的实施例,并且另一方面来自于3D针织结构的网孔图案。从而,由于体内迁移的风险被限制,因此其植入的耐用性是有利的,其必然降低排异的风险。其次,无论支架移植物可能遇到的动脉弯曲是否符合某些血管的特定解剖结构,都避免了阻塞的风险。最后,避免了任何泄漏风险,特别是由3D结构的网孔结构造成的泄漏风险。
Claims (15)
1.血管支架移植物(1),其由管状针织织物结构形成,在所述针织织物结构的网孔内集成至少一根螺旋状连续纬纱(3、14、22),其沿着支架移植物的整个主要外形尺寸延伸,所述至少一根纱线(3、14、22)由形状记忆合金制成,该形状记忆合金先前已经经过这种处理、并且特别是这样的热机械处理,使得在人体温度下,所述纱线通过超弹性或形状记忆的作用赋予所述结构其管状形状。
2.根据权利要求1所述的血管支架移植物,其特征在于,根据选自查米尤斯丝缎、双针织或纬链组中的编织,在双针床Rachel织机或钩织机上获得所述针织织物结构。
3.根据权利要求1和2中任一项所述的血管支架移植物,其特征在于,所述针织织物结构的直径在5毫米至40毫米的范围内。
4.根据权利要求1和2中任一项所述的血管支架移植物,其特征在于,其包括在减小所述针织织物结构的直径之后获得的分支,所述分支被构造用于形成次支架移植物(6、7)。
5.根据权利要求1至4中任一项所述的血管支架移植物,其特征在于,所述针织织物结构由选自包括PET(聚对苯二甲酸乙二醇酯)、聚丙烯、ePTFE的组的生物相容的材料和PGA类型的可生物降解或可生物再吸收的材料制成。
6.根据权利要求1至5中任一项所述的血管支架移植物,其特征在于,所述纬纱(3、14、22)由镍钛制成的形状记忆材料制成,并且其连续地被插入到所述针织织物结构的网孔中。
7.根据权利要求1至6中任一项所述的血管支架移植物,其特征在于,所述纬纱具有50微米至200微米范围内的直径。
8.根据权利要求1至7中任一项所述的血管支架移植物,其特征在于,所述支架移植物的纵向、即沿着其主要外形尺寸的变形在0%至30%的范围内。
9.根据权利要求1至8中任一项所述的血管支架移植物,其特征在于,其涂有胶原、白蛋白或明胶以赋予所述支架移植物关于血流粘度的接近0.1毫升/平方厘米/分钟的渗透率,并且因此在符合所述支架移植物的生物相容性的同时必然避免泄漏。
10.根据权利要求9所述的血管支架移植物,其特征在于,所述胶原、白蛋白或明胶涂层也包括肝素、碳或含氟聚合物。
11.形成血管支架移植物的方法,包括:
在双针床织机上通过经编针织形成两层,所述两层在生产方向上在各自边缘的水平处连接在一起,以最终限定管状结构;
在双针床的水平处插入由形状记忆纱线制成的连续纬纱,在生产方向上错开地插入所述两层的网孔中,所述连续纬纱通过围绕所述床转动、典型地相对于所述结构的生产方向呈螺旋状地被传送到所述针床的水平处。
12.根据权利要求11所述的形成血管支架移植物的方法,其特征在于,所述形状记忆纱线遵循的螺旋的节距是恒定的,并且为1/1,即每缝一针,纬纱就围绕所述管状织物结构转动一次。
13.根据权利要求11所述的形成血管支架移植物的方法,其特征在于,所述形状记忆纱线遵循的螺旋的节距是恒定的,并且在从1/2至1/10的范围内。
14.根据权利要求11至13中任一项所述的形成血管支架移植物的方法,其特征在于,所述双针床织机是RACHEL织机或钩织机,其中在所述织机的双针床的水平处以在生产方向上插入错开的方式插入所述纬纱(3、14、22),该连续纬纱通过围绕两个针床转动被传送到所述两个针床的水平处,并且因此与由在所述两个针床的水平处的针织引起的两个织物层的形成同时进行。
15.根据权利要求14所述的形成血管支架移植物的方法,其特征在于,所述纬纱本身在其插入所述RACHEL织机或所述钩织机的双针床之前先行形成波纹。
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FR1902757A FR3093913B1 (fr) | 2019-03-18 | 2019-03-18 | Endoprothèse vasculaire |
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PCT/FR2020/050447 WO2020188180A1 (fr) | 2019-03-18 | 2020-03-05 | Endoprothese vasculaire |
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US20050165470A1 (en) * | 2004-01-22 | 2005-07-28 | Jan Weber | Medical devices |
US20060058862A1 (en) * | 2004-09-10 | 2006-03-16 | Scimed Life Systems, Inc. | High stretch, low dilation knit prosthetic device and method for making the same |
CN1919354A (zh) * | 2006-08-30 | 2007-02-28 | 郑军 | 人造血管丝素、胶原蛋白共混预凝涂层 |
US20070168019A1 (en) * | 2006-01-13 | 2007-07-19 | Aga Medical Corporation | Intravascular deliverable stent for reinforcement of vascular abnormalities |
WO2016200103A1 (ko) * | 2015-06-09 | 2016-12-15 | 전북대학교산학협력단 | 재팽창이 가능한 스텐트 및 이를 이용한 치료 장치 |
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US6814747B2 (en) | 1995-09-08 | 2004-11-09 | Anthony Walter Anson | Surgical graft/stent system |
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Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
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US20050165470A1 (en) * | 2004-01-22 | 2005-07-28 | Jan Weber | Medical devices |
US20060058862A1 (en) * | 2004-09-10 | 2006-03-16 | Scimed Life Systems, Inc. | High stretch, low dilation knit prosthetic device and method for making the same |
US20070168019A1 (en) * | 2006-01-13 | 2007-07-19 | Aga Medical Corporation | Intravascular deliverable stent for reinforcement of vascular abnormalities |
CN1919354A (zh) * | 2006-08-30 | 2007-02-28 | 郑军 | 人造血管丝素、胶原蛋白共混预凝涂层 |
WO2016200103A1 (ko) * | 2015-06-09 | 2016-12-15 | 전북대학교산학협력단 | 재팽창이 가능한 스텐트 및 이를 이용한 치료 장치 |
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FR3093913A1 (fr) | 2020-09-25 |
WO2020188180A1 (fr) | 2020-09-24 |
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