CN1231591A - 涂层处理的心脏修复装置 - Google Patents
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Abstract
本发明包含在假体(10)部分上的一金属涂层,以增强可植入装置(10)或用于植入假体的织物或缝线的总体可接受性。最好的金属物为银,它被施加到暴露于心脏组织的表面。这些用银处理过的装置部分抑制或大大减少了引发心内膜炎的细菌的寄宿且不影响装置的总体相容性。为了增加心肌的可收缩性,本发明还公开了一种以环形物形式安装在心室上的被动弹性辅助装置。
Description
本发明涉及一种可植入的心脏修复装置,尤其是表面经过涂层处理的修复装置。
用修复装置取代或修复病变的心脏瓣膜为外科医生提供了一种治疗由于疾病和先天不足而引起的瓣膜缺陷的方法。一种典型的程序包括天生瓣膜的去除和机械的或生物修复瓣膜的取代。另一种技术就是使用一个瓣环成形术环给对支撑瓣膜天生环面的天生根座提供结构支撑。
研究表明:心脏结构的异常使得心脏容易发生细菌侵入性瓣膜的感染,即亚急性细菌性心内膜炎(SBE)。组织的异常在心脏内可以中断血液流动模式,产生涡流和瘀积区域。流过的细菌可以附着到处于异常血液流动模式的区域内的心脏组织上,从而感染心脏组织(心内膜炎)。心内膜炎一旦发生就极难治愈。一旦天生的瓣膜因感染而被损害,就需要更换瓣膜。鉴于生物瓣膜的低感染倾向性,通常在更换瓣膜的病例中采用它。
在随后的植入中,存在手术后全身感染的危险。修复瓣膜炎(PVE)是一种与心脏瓣膜假体相关联的感染。心脏瓣膜包括一用于将心脏瓣膜缝合到心脏组织上的织物缝合套或其它织物部分。经过一段时间,纤维组织长到缝合套内并且将缝合套包住。细菌可以寄宿在与植入物和缝合套织物相关联的伤口处。研究表明:组织长进缝合套材料内的过程可以吸引流通循环中的细菌或其它病原体。为此,心脏瓣膜接受者应注意有关引起细菌进入他们的血液中的行为,如有关牙科的工作。
关于心脏瓣膜更换的问题,必须小心谨慎以确保瓣膜制造中的无菌性,以防止在瓣膜植入更换时被感染。例如,为了减少在手术前被感染的机会,一些外科医生在植入前使用抗原体。然而,这些技术在效果上都存在很多缺点。另外,有人提出使用为抗体疗法而设计的药物传递系统,但这种系统也有缺点。尽管作了努力,但修复瓣膜炎(PVE)仍有2%-4%的发生率。
其它一些现有的技术包括颁发给Menaker的美国专利第5464438号。它告诉我们如何使用金属涂层处理生物医疗装置(如心脏瓣膜)。这种表面处理的目的是防止血栓形成。
与医药产品的使用相比,本发明的一个方面包括假体(通常为织物)部分上的金属涂层,以增强可植入装置的整体可接受性。这样的金属最好为银,其被施加到暴露于心脏组织的表面上。机械的和生物心脏修复瓣膜可以得益于此涂层而且它还可以施加到瓣环成形术环,复合的带瓣的植入物,缝线,小拭子,心脏环形物或者其它可植入的装置上。由银处理过的装置部分抑制或极大减少了引起心脏瓣膜炎的细菌的寄宿,且不影响装置的整体生物相容性。
下面参照附图及实施例说明本发明的修复装置。在所有的图中,相同的标号表示相同的结构。其中
图1示出了一个心脏修复瓣膜;
图2示出了一个具有附加的大动脉植入物的心脏瓣膜;
图3示出了一个修复瓣环成形术环;
图4示出了一个肺部的具有瓣膜的植入物的假体;
图5A和图5B是示出本发明的使用一小拭子缝合附件的技术的透视图;
图6是示出本发明的一个方面中的一个与心脏有关的被动辅助装置的零件分解图;
图7示出了一个用于对纤维或织物进行涂层处理的装置。
图1是一机械式心脏瓣膜10的截面图。本发明公开了一个双叶片瓣膜,但是,如同生物心脏修复瓣膜,也可考虑使用单个或多个咬合器。应这样理解:本技术可应用在其它的瓣膜和修复装置中。心脏瓣膜10包括形成血流环面13的孔环12。孔环12位于并定位一对咬合器,如图所示的咬合器14和咬合器16。这对咬合器可在第一开启位置和第二关闭位置之间运动。在使用中,血液流过环面13并控制两个咬合器的位置。瓣膜10的缝合套18由外科技术缝制在心脏组织上并且最后由纤维组织包住。
缝/缝合套或此处描述的任何修复装置中所使用的织物最好由一个编织的聚酯或聚四氟乙烯(PTFE)材料组成,由编织的双丝绒聚酯材料更好,如由Meadox Medical有限公司提供的。
有几种方法可将银涂到装置表面上。第一种,在形成织物之后将使用到该装置结构中的织物涂上银。第二种,在织物形成之前,将制成织物的纱线或纤维涂上银。第三种,在织物部分构成后,织物部分本身可被涂上银。另外,银涂层可直接施加于装置上。在一个实施例中,所要求的银的数量是很低的,一般是每克织物含1-100mg银,最好是每克织物含20-50mg银。涂纤维最好,这是因为此种技术可以使银在成品上更好地分布。对于所有的涂层方法,织物必须保持多孔性以便具有足够的组织生长特性。
对于有移植片固定模的心脏生物修复瓣膜,用与上述同样的方法将用于缝合套的织物进行涂层处理。也可以考虑把银涂到用于这些瓣膜的移植片固定模上以进一步增强装置的抗感染能力。在没有移植片固定模的生物心脏瓣膜内,外层织物外套也可用银涂层处理。
图2示出了一个大动脉瓣膜植入物,其包括一个连接到植入物20上的机械式心脏瓣膜10。植入物20部分最好由聚合物制成,例如由MeadoxMedical有限公司提供的编织双丝绒聚酯材料。尽管在一些实例中,聚酯材料具有很好的耐药性,但是依据外科医生的偏好,也可使用聚四氟乙烯(PTFE)。植入物20可以用在上行的动脉的修复或修复更换并且必须接受其它的连接,如冠状接合。植入之后,植入物暴露在由心脏左边过来的相当高压力的血流中,通常,植入物用不同的预先凝结剂涂层处理,如骨胶原或凝聚体。在此应用中,银涂层可作预先凝结剂的衬里,而且它是否影响预先凝结剂的吸收率还不清楚。密封的植入物的表面是否影响银涂层的益处还不清楚,而且仅有缝合套在一些应用中要求用银处理也是在考虑之中。银涂层也可以直接施加于骨胶原或其它的一些凝结剂中。
图3是通常为圆形的瓣环成形术环22的剖面图。瓣环成形术环22包括一个织物外层24,例如,编织的聚酯材料,其包围着框23。不象瓣膜假体,织物覆盖了瓣环成形术环22的整个内表面。框23可以是刚性的、半刚性的或柔性的,且可由金属或聚合物材料制成。聚合物材料制成的框23的例子包括高密度的聚乙烯(HDPE)、聚乙烯对酞酸盐或硅酮。例如,金属框23可以包含埃尔基洛伊耐蚀游丝合金、钴、铬及镍合金或钛。在使用中,瓣环成形术环被用于重新构成和支撑天生的环面,而作为一个愈合反应的结果,整个瓣环成形术环通常由纤维组织包住。
图4是示出一个肺部的具有瓣膜植入物的假体40的剖视图。该装置40被用于修复和重新构成肺部的瓣膜和动脉。瓣膜10部分放置在植入物部分41内,并且一小的织物缝合套42紧贴在瓣膜10位置处且在植入过程中起辅助作用。如果不使用预先凝结剂,最好用银对植入物和缝合套42进行涂层处理。
图5A和图5B是示出用小拭子52和缝线54将缝合套18缝合在天生的心脏组织50上的透视图。图5A示出了用小拭子52和缝线54不翻转褥垫的缝合技术,图5B示出了用小拭子52和缝线54翻转褥垫的缝合技术。本发明的一方面包括一个具有银涂层的小拭子52和/或缝线54。在本实施例中,缝合套18、小拭子52和缝线54都进行涂层处理,并且天生的组织50的表面只可以暴露于涂银的表面。通常,小拭子52是由聚四氟乙烯(PTFE)垫或聚酯制成。小拭子在医学工业中被广泛使用,例如,来自Ethicon、C.R.Bard和Johnson & Johnson的小拭子。本发明适用于各类附件技术,其中包括缝线且不含小拭子、钩、环钩、夹子、钳子或其它倒钩。
图6是包含一个用于心脏62的被动辅助装置60的本发明的一个方面的零件分解图。被动辅助装置60包括环形物64和适于安放在心脏62的心室顶部68上的缝合套66。环形物64由可扩张的具有弹性的且具有生物相容性的材料(如聚合物、橡胶、位于心脏周围的组织及可伸缩的聚合物织物等等)组成,并且当安放在心室顶部68上时,它可以扩张到被扩张过的外部70处。包含适于缝合到纤维平面72处的瓣环成形术环的缝合套66可由上述的任何适用的缝合套材料制成。被动辅助装置60用于提供一个病变心脏的所增加的心肌收缩性。环形物64由高弹性的具有生物相容性的材料制成并且包围在心室周围,以便在心脏收缩时提供一个压力。在一些实施例中,用涂层处理装置60可使它具有更好的生物相容性和较少的血栓形成。本领域技术熟练人员将注意到:任何直接的心肌附件(如纤维平面)可用来将环形物附在心脏上,这些附件包括缝线、钩、胶等等。装置60可用不同材料进行涂层处理,这些材料包括银或者其它的抗微生物材料,缩氨酸和磺酸化的水凝胶。
研究发现:用薄银片处理的心血管假体的涂层部分可以阻止装置的感染。在一些例子中,修复装置的整个结构部分并不都可以涂上银,如在缝线标记处。另外,活体实验还证明了没有超量血栓形成的极好的组织生长。少量的银游离到周围的组织中可以进一步提高抗微生物保护性。
薄膜银涂层可以放在或携带于织物部分、纤维或用公知的方法制成的缝合套上。在整个申请文件中,词汇“涂上”或“被涂上”可以意味着:根据银的使用方法,银可以被涂在装置或元件的表面上或者可以在装置或元件内植入或植进以及置于装置或元件表面上。例如,用蒸发沉积工艺或喷涂工艺,可以施加银涂层。蒸发沉积技术的使用已公开在颁发给Sawyer的美国专利第4167045号中。尽管可使用多种该技术中的任何一种产生银涂层,但最重要的是涂层必须极为牢固地粘结在织物或别的材料上以防止具有细胞毒素的银材料过多地在全身循环,同时还要为组织生长保持必要的多孔性。
现在人们已公知利用离子加速转换系统(在高真空环境中)蒸发沉积金属的工艺技术。转让给Spire公司的美国专利第5474797号中,就提供了适于银涂于织物材料上的技术。
图7示出一个给纤维涂层的例子,但不限于此。处理槽30包含一供卷轴32和一收卷轴34。当银原子由离子源38加速并直接电镀在纤维36上时,纤维36从一个轴到另一个轴移动。正如本技术所述,在涂银涂层之前,其他金属也可以粘结在纤维上。可以使用类似的方法通过使用固定架(如心轴)将织物或组合好的缝合套进行涂层处理,转动或放置织物或缝合套以提供一均匀一致的银涂层。
为了获得均匀一致和高粘着性的银涂层,在本发明中,考虑使用蒸发沉积技术,如离子束植入法和离子束辅助沉积法(IBAD),并且最好选用离子束辅助沉积法。
可以理解,传统的涂层处理技术,例如喷涂技术,会导致织物或装置其余部分喷涂不到或某些部分沉积量过多。尽管认为在整个假体的被处理部分上银原子分布均匀一致有利于修复的应用,但是也可以接受不均匀的分布。对用于制造假体的被处理部分的纤维或纱线进行涂层处理可解决该不均匀的问题,并且可使在被处理部分的银的分布更均匀一致。使用传统方法,可能形成用于制造缝合套18或上述的心血管修复装置的其它部分的织物。
在织物或缝合套被编织好之后,将对之进行涂层处理的替代工艺被认为是在本公开的范围内的一种取代技术。在本实施例中,必须保持必要的适于组织生长的多孔性。
在一个实施例中,银被轻微地氧化,这可以提供一个加强了的生物活性抗菌表面。例如,一典型的涂于Dacron牌聚酯样品上的银表明含氧化银为9%和金属银为91%。尽管该表面的电特性不为其特征,但电传导特性也起着重要的作用。当银与其它材料组合时,更易于电离银,从而增强了抗微生物的效果。
实例1:
双丝绒编织的聚乙烯对苯酸盐(Meadox产品号33FR)(聚酯类)的织物由Meadox Medicals有限公司提供。正如在美国专利第5474797号中描述的,通过使用离子束辅助沉积工艺使银得以应用。
可进行两种不同的化验分析来确定涂银织物的抗微生物效果。在DowCorning Corporate测试方法0923中,三个750mg的涂银织物试样((表1中的1号样品)和三个750mg的未涂银织物试样((表1中的2号样品)分别暴露在包含表皮葡萄球菌ATCC29886、酿脓链球菌ATCC8668或白色念珠菌ATCC10231的75毫升溶液中,其浓度都为(1-2)×104CFU/ml。
表1
细菌数 | ||||
测试有机体 | 样品号 | 零时 | 1小时 | 减少百分数n |
表皮葡萄球菌ATCC29886 | #1 | 23.000 | 1.200 | 94.78 |
表皮葡萄球菌ATCC29886 | #2 | 20.000 | 15.000 | 25.00 |
酿脓链球菌ATCC8668 | #1 | 16.000 | 90 | 99.44 |
酿脓链球菌ATCC8668 | #2 | 16.000 | 16.000 | NR |
白色念珠菌ATCC10231 | #1 | 14.000 | 360 | 97.43 |
白色念珠菌ATCC10231 | #2 | 11.000 | 12.000 | NR |
如表1所示,确定开始时的细菌数和接种一小时后的细菌数以确定细菌减少的百分比。结果显示,与仅仅减少25%的细菌的对照(未涂银)样品相比,涂银织物上的细菌减少了95%-99%。
在抑制细菌活性的NYS63测试中,1平方英寸的一片涂银织物暴露在下面指定浓度的有机体中:
表皮葡萄球菌 (5.8×104CFU/0.2ml)
酿脓链球菌 (2.8×104CFU/0.2ml)
白色念珠菌 (3.0×104CFU/0.2ml)
表2
24小时有机体数 | 减少百分数 | |||
同样样品# | 表皮葡萄球菌 | 酿脓链球菌 | 表皮葡萄球菌 | 酿脓链球菌 |
1 | 70×102 | <1.0×102 | 98.79 | 99.64 |
2 | <1.0×102 | <1.0×102 | 99.83 | 99.64 |
3 | 2.0×102 | <1.0×102 | 99.66 | 99.64 |
4 | 1.0×102 | <1.0×102 | 99.83 | 99.64 |
5 | 2.5×102 | <1.0×102 | 99.57 | 99.64 |
24小时有机体数 | 减少百分数 | |||
同样样品# | 白色念珠菌 | 白色念珠菌 | ||
1 | <1.0×102 | 99.67 | ||
2 | <1.0×102 | 99.67 | ||
3 | <1.0×102 | 99.67 | ||
4 | <5.0×102 | 98.33 | ||
5 | 1.9×103 | 93.67 |
如表2所示,确定暴露24小时后所残留的细菌总数。结果显示,对于涂银织物,有机体中减少的百分数为94%-99.8%。
实例2:
如实例1所述,对织物进行涂层处理并将其用于制造由一半涂银织物和一半未涂银织物组成的缝合套。将混合的缝合套装配到一个St.JudeMedical牌机械式心脏瓣膜假体上。
在绵羊的二尖瓣模型中,术后30天,对血容性和组织的生长特性进行评估。并对对照组部分和涂层处理部分的组织反应进行总体上和组织病理学上的评估。将缝合套样品在成形外科上包埋,切片,为了组织病理学上的分析,用苏木精和四溴荧光素染色。结果表明,关于组织生长和血容性对于涂层织物和未涂层织物的愈合情况是类似的,这就说明银对装置的安全性没有影响。
用PTFE缝合套制造与上述聚酯瓣膜类似的混合瓣膜。也是一半涂银材料,一半未涂银材料。瓣膜植入到羊的二尖瓣模型中30天。总的检查表明愈合的情况和组织反应类似于聚酯的缝合套和瓣膜。
本发明具有几方面的优点。在不同生物医疗假体上放置一层薄薄的粘结牢固的银涂层以为装置提供抗微生物特性。结果,机械式心脏瓣膜可使用在其它装置优先考虑的条件下,例如急性心内膜炎,从而为外科医生和病人提供了更好的选择。例如,自体植入物是患急性心内膜炎的病人的瓣膜的更换中首选的装置。自体植入物供应量少,要求高并且通常是在小儿科病例中才出现。因此,具有抗微生物涂层的修复装置为成人的心内膜炎患者提供了一意义重大的新的选择,从修复装置上沥滤的银很少的特点可提供持久的效果,其进一步增强了装置抗微生物特性。银涂层不影响附着在其上的物质。而且,在假体上使用银涂层表明细菌数可大大减少。本发明也可以减少将瓣膜浸泡在抗原体的溶液中的情况下的外科手术的时间,因为在外科手术中去除了浸泡步骤。
尽管参照最佳实施例详细描述了本发明,但本领域技术熟练人员可在不脱离本发明的宗旨和范围的情况下在形式和细节上作些改变。例如即使在施加银时蒸发沉积工艺被描述为最佳方法,但也可考虑在本发明中使用其它一些化学方法,包括在容解银的溶液内浸泡纤维或织物,或者将纤维或织物浸渍或浸没在银溶液中,或者电镀,或在织物/缝合套内混合进银颗粒。而且,本发明还可用除银之外的抗微生物材料,如金、铂、钯、铱(即贵重金属),铜、锡、锑、铋和锌或它们的合金。另外,本发明的银涂层或银植入可以用在用于植入到或接近天生心脏的任何装置上并且不限于此处所阐述的具体的装置。本发明的被动辅助装置具有特别的作用,因为该装置不是同体的而且能提供其它的选择,尤其对于成年患者。
Claims (15)
1.一种可植入的心脏假体,其特征在于,所述假体包括:
一具有外圆周和内圆周的孔环,所述环限定了一环面;
所述环面限定了一用于血液流动的通道;
一织物部件至少连接在所述孔环的所述外圆周上;
所述织物部件上携带有银。
2.如权利要求1所述的装置,其特征在于,所述织物在离子束辅助的高真空环境下被涂上银,这样所述银原子就插入所述织物表面中。
3.如权利要求1所述的装置,其特征在于,所述织物在高真空环境下被涂上银,这样所述银原子被涂在所述织物表面上。
4.如权利要求1所述的装置,其特征在于,所述织物部件由多个携带有银的纤维组成。
5.如权利要求1所述的装置,其特征在于,它还包括:
第一咬合器,
第二咬合器,
所述第一咬合器和第二咬合器可移动地安装在所述环内,
一连接在所述环上的缝合套;以及
所述缝合套上携带有银。
6.如权利要求1所述的装置,其特征在于,它包含一心脏瓣膜。
7.如权利要求6所述的装置,其特征在于,它还包括:
一连接到所述环上的植入物;并且所述植入物由所述涂银的织物制造。
8.如权利要求1所述的装置,其特征在于,它还包括一移植片固定模。
9.如权利要求1所述的装置,其特征在于,它包含一瓣环成形术环。
10.如权利要求1所述的装置,其特征在于,它包含一生物修复瓣膜。
11.如权利要求1所述的装置,其特征在于,它包含一瓣膜植入物。
12.如权利要求1所述的装置,其特征在于,它包含一缝合套。
13.如权利要求1所述的装置,其特征在于,它包含一用于将可植入的心脏假体安装到患者的天生组织上适于与涂银的织物配合的涂银小拭子。
14.一种可植入假体,其特征在于,它包括:
一假体本体;
一放置在假体本体上的适于容纳在此穿过的缝线的织物部件;
一适于与织物部件配合并容纳在此穿过的缝线以固定其间的天生组织的小拭子,并且该小拭子上涂银。
15.一用于增强天生心脏心肌的收缩性的被动辅助装置,其特征在于,
它包括:
一适于在心脏心室上固定的环形物;
该环形物由具有弹性的生物相容的材料构成并且其尺寸在松弛状态时比心脏心室的顶部小,由此适于对心脏的心室提供一附加喷射力。
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- 1997-01-31 US US08/791,890 patent/US5895419A/en not_active Expired - Fee Related
- 1997-09-30 TR TR1999/00728T patent/TR199900728T2/xx unknown
- 1997-09-30 AU AU46049/97A patent/AU4604997A/en not_active Abandoned
- 1997-09-30 BR BR9712169-0A patent/BR9712169A/pt not_active IP Right Cessation
- 1997-09-30 NZ NZ334489A patent/NZ334489A/xx unknown
- 1997-09-30 JP JP10516800A patent/JP2001501516A/ja active Pending
- 1997-09-30 WO PCT/US1997/017613 patent/WO1998014139A1/en not_active Application Discontinuation
- 1997-09-30 IL IL12887497A patent/IL128874A0/xx unknown
- 1997-09-30 CN CN97198387A patent/CN1231591A/zh active Pending
- 1997-09-30 PL PL97332498A patent/PL332498A1/xx unknown
- 1997-09-30 EP EP97944588A patent/EP0948297A1/en not_active Withdrawn
- 1997-09-30 KR KR1019990702681A patent/KR20000048716A/ko not_active Application Discontinuation
- 1997-09-30 CA CA002267612A patent/CA2267612A1/en not_active Abandoned
- 1997-09-30 CZ CZ991070A patent/CZ107099A3/cs unknown
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CN101801315B (zh) * | 2007-09-17 | 2012-07-04 | 沃尔德马连接两合公司 | 内置式假肢部件 |
US8845751B2 (en) | 2007-09-21 | 2014-09-30 | Waldemar Link Gmbh & Co. Kg | Endoprosthesis component |
Also Published As
Publication number | Publication date |
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IL128874A0 (en) | 2000-01-31 |
JP2001501516A (ja) | 2001-02-06 |
CA2267612A1 (en) | 1998-04-09 |
AU4604997A (en) | 1998-04-24 |
KR20000048716A (ko) | 2000-07-25 |
US5895419A (en) | 1999-04-20 |
BR9712169A (pt) | 1999-08-31 |
CZ107099A3 (cs) | 1999-08-11 |
WO1998014139A1 (en) | 1998-04-09 |
TR199900728T2 (xx) | 1999-07-21 |
EP0948297A1 (en) | 1999-10-13 |
PL332498A1 (en) | 1999-09-13 |
NZ334489A (en) | 2000-11-24 |
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