CN1348389A - 用来张开管状组织的斯滕特氏模 - Google Patents

用来张开管状组织的斯滕特氏模 Download PDF

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CN1348389A
CN1348389A CN00806468A CN00806468A CN1348389A CN 1348389 A CN1348389 A CN 1348389A CN 00806468 A CN00806468 A CN 00806468A CN 00806468 A CN00806468 A CN 00806468A CN 1348389 A CN1348389 A CN 1348389A
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安德烈亚斯·乔丹
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Abstract

一种可植入到管状组织或其它空腔器官中的由金属和/或非金属材料制成的斯滕特氏模,它均匀地涂有由永磁性的核芯和至少一个吸附在该核芯上的外壳组成的毫微级微粒,外壳与斯滕特氏模表面持久地结合。由于有该涂层可通过一个交变磁场的作用在一个可临床接受的场强/频率－组合范围内在得到高的功率吸收时,一方面在一个植入体通过细胞生长而长入时所要求的温度范围,另一方面在一个使再次变狭窄的植入体再生的温度范围进行一个植入体的有选择的均匀的加热,此外,还可进行一个定位。

Description

用来张开管状组织的斯滕特氏模
本发明涉及一种用来张开人体内的管状组织的并且通过对该组织的热作用而避免重新变狭窄的病变的斯滕特氏模(stent)。
在处理管状空腔器官，例如血管、尿路等等的狭窄性病变或处理血管动脉瘤时为了张开变窄的组织在有关空腔器官内植入斯滕特氏模或管状内假体器官，也就是说基本上管状的由金属和/或聚合物材料组成的支承体。但是在应用这种类型的植入体时问题在于，经常在植入后不久便出现重新变窄或阻塞，因此需要具有很大风险和费用昂贵的重新手术。在心血管斯滕特氏模重新变窄的情况下需要作昂贵的旁路手术的不在少数。
通常为了血管造影术控制地机械清除斯滕特氏模的阻塞区采用专用的导管结合微型或激光刀具。但是这种类型的再生最多只能进行两次。接着必须通过新的植入体代替(原来的)斯滕特氏模组织。
为了排除上述缺点已经有人建议采用放射性的斯滕特氏模(US-专利5840009)，以便在射线的近场内避免内皮或光滑肌肉细胞重新堆积在斯滕特氏模内。但是这里难以确定确切的放射剂量，此外对于其它细胞的毒害作用也不清楚。
为了避免重新变窄提出了带有涂层的其他种类斯滕特氏模，涂层由抗粘着分子(DE 19713240)、纤维蛋白/纤维蛋白原(US 5660873)、硅(US 5330500)或碳(US 5163958)组成，或者带有治疗学交付系统(Therapeutika-Abgabesystem)的斯滕特氏模(US 5439446)。
其次已知由可热可逆地变形的材料组成的斯滕特氏模(US 5197978)，它装入空腔器官的变窄区内并在热作用下借助于一气囊导管扩张并可重新回到其原始形状，斯滕特氏模与一电加热元件直接连接。最后在资料(US 5178618)中也介绍了可借助于外部的无线电波加热到50至100℃之间的、可扩张的斯滕特氏模，以使人体内的管状组织疏通和变窄。这里在斯滕特氏模材料内热量的产生防止光滑肌肉细胞的增生，现在认为，这种光滑肌肉细胞与斯滕特氏模的重新变窄和与之相关联的—开头所述的—不利后果有关。
但是体内的能导电的、含铁的重新变狭窄的斯滕特氏模的再生由于其通过磁滞现象和涡流损失所引起的发热只有在比较高的场强—频率组合时才有可能，这是不利的，这时由于在导电的生物组织内的涡流损失导致身体表面的功率吸收(Leistungsabsorption)，从而导致外围脂肪组织和其他未参与的组织部分的不希望的过热。因此不管是金属的还是非金属的植入物借助于热量再生迄今为止还不可能。
因此本发明的目的是，这样地形成一种开头所述类型的斯滕特氏模，使得不管是在金属的还是非金属的结构时可以任意地选择地进行假体器官的加热，以便一方面避免重新变窄或阻塞，另一方面使斯滕特氏模容易长入有关空腔器官。
按本发明这个目的用这样的斯滕特氏模来实现，它由金属或非金属材料组成，并且一方面为了通过磁共振X射线断层摄影确定位置，另一方面为了其在具有一定的、可临床应用的场强和频率的交变磁场中均匀和有控制地加热和更好的功率接收用由常磁性的核芯组成的毫微级微粒和一种能附着在斯滕特氏模上的涂料涂覆。
用按本发明的、在其表面上均匀分布地结合毫微级微粒的斯滕特氏模植入体不管在金属还是非金属结构时在一交变磁场的场强和频率的可临床应用的区域内可以建立一可调的、仅仅局限在斯滕特氏模上的温度，它保证在略高于正常的生理学温度的范围内通过有利于细胞的重新形成使植入体快速长入，并在50至60℃的温度范围内使变窄的斯滕特氏模再生。此外具有毫微级微粒的涂层使得不仅在金属的、而且在非金属的植入体时在场强小于10kA/m时和临床允许的频率范围内可以有高的功率接收以及斯滕特氏模的均匀加热。其次由于设置的涂层可以与应用的植入材料无关地通过磁共振X射线断层摄影确定位置。
在本发明的另一种结构中毫微级的微粒由一个含氧化铁的、但是尤其是由纯氧化铁组成的核芯构成，此核芯是铁磁性的(Ferro-magnetisch)、亚铁磁性(ferri-magnetisch)的或尤其是超级常磁性的并具有一由至少一个吸附在核芯上的外壳组成的涂层。外壳有能够形成阳离子集团的活性集团，以使外壳与斯滕特氏模表面持久地结合。毫微级微粒的制造按已知的，例如在德国的公开资料19515820、19614136和19726282中叙述的方法进行。
本发明的其他特征和合适的结构以及优点由从属权利要求和对一个实施例的以下说明中得到。
在进行的试验中纤维蛋白-纤维蛋白原溶液的纤维蛋白原成分与由用氨基硅烷涂覆的毫微级微粒组成的15mg/ml的制剂良好地混合。接着将做成可扩张的金属组织的市场上常见的血管内的斯滕特氏模浸入这样制备好的纤维蛋白-纤维蛋白原溶液内。在接着用气囊导管使用毫微级微粒涂覆的斯滕特氏模扩张时涂层牢固地保留在斯滕特氏模的金属丝组织上。涂覆的斯滕特氏模装入一灌满水的管子内并在100kHz的频率下经受强度为10至18kA/m的交变磁场。为了比较在其他条件相同的情况下将未涂覆的斯滕特氏模也放在交变磁场内。这时断定，在涂覆的斯滕特氏模时在场强为10kA/m时便进行充分的功率接收并进行相应的、对于再变狭窄的斯滕特氏模的再生所需要的加热。相反未涂覆的斯滕特氏模在这种重要的、不出现其他组织的不许可的加热的临床场强范围内并未加热。而是记录下了这样的事实，只有在场强为15kA/m或更高时未涂覆的斯滕特氏模才达到足够高的功率吸收，而随之而来的是不仅斯滕特氏模还有其他组织也加热。也就是说，用毫微级微粒涂覆的斯滕特氏模在10kA/m时的功率接收基本上相当于未涂覆的斯滕特氏模在15kA/m时的功率接收。
由作为场强和频率的函数算出的功率接收(W/g)和在斯滕特氏模所植入的血管或空腔器官内的灌流速度可以通过在一定频率的情况下施加的交变磁场算出在人体内的斯滕特氏模加热时的温度-时间曲线。在实际应用中通过一个斯滕特氏模—植入导管在血管造影术控制的情况下在斯滕特氏模内插入一光纤维温度传感器并在交变磁场作用期间控制温度。为了加速植入的斯滕特氏模的长入斯滕特氏模被加热到略高于正常生理学水平的温度，使得激励植入体表面的细胞生长。在以后由于斯滕特氏模植入体的再次变狭窄需要再生时在施加交变磁场以前先确定斯滕特氏模区域内的灌流(Perfusion)。植入体的准确位置事先可以通过用核自旋X射线断层摄影仪对斯滕特氏模进行对比度显示或投影精确地确定。

Claims (12)

1.张开管状组织并通过对它的热作用避免再次变狭窄病变的斯滕特氏模，其特征为一由金属和/或非金属材料组成的管状支承体，它一方面为了通过磁共振X射线摄影确定位置，另一方面为了其在一具有一定的可临床应用的场强和频率的交变磁场内均匀和有控制地加热和功率接收，用由一具有附着在斯滕特氏模上的涂料的常磁性核芯组成的毫微级微粒涂覆。
2.按权利要求1的斯滕特氏模，其特征为：毫微级微粒由一种含氧化铁的、铁磁性、亚铁磁性的或超级常磁性的核芯和至少一个覆盖在它周围的外壳组成，外壳一方面可吸附在核芯上，另一方面占有能移形成离子组的活性族，并被人体组织这样缓慢地分解，使得外壳持久地结合在由金属和/或非金属材料构成的斯滕特氏模的表面上。
3.按权利要求2的斯滕特氏模，其特征为：毫微级的微粒的核芯由纯氧化铁组成，并包含磁铁矿和/或磁赤铁矿。
4.按权利要求2的斯滕特氏模，其特征为：核芯由Fe(II)/Fe(III)的比例为1∶1至1∶3形式的纯氧化铁微粒组成。
5.按权利要求2的斯滕特氏模，其特征为：核芯由含铁的混合氧化物组成，其中不同于铁的金属原子的含量不大于70％，尤其是不大于35％金属原子含量。
6.按权利要求2的斯滕特氏模，其特征为：最内层(最靠近核芯的)外壳的活性组由单体氨基硅烷或羧基族构成。
7.按权利要求2至6之任一项的斯滕特氏模，其特征为：类似于内部的外壳吸附在氧化铁核芯上其牢固地吸附在斯滕特氏模表面上通过微乳液技术，尤其是通过由表面活性剂产生的活性进行。
8.按权利要求2的斯滕特氏模，其特征为：设有毫微级微粒的外层壳体，以与生物分子连接。
9.按权利要求8的斯滕特氏模，其特征为：生物分子是起溶解纤维或抗凝结作用的酶，例如蛋白酶，和/或肝素或肝素的衍生物。
10.按权利要求1至9之任一项的斯滕特氏模，其特征为：毫微级微粒的平均直径小于100纳米，尤其是不超过50纳米，特别优选不超过30纳米。
11.按权利要求10的斯滕特氏模，其特征为：中等尺寸的微粒在1至40纳米，尤其是3至30纳米之间。
12.按权利要求1的斯滕特氏模，其特征为：通过交变磁场使其加热用来在在核自旋X射线摄影仪范围内产生迅速的梯度场。
CNB008064687A 1999-04-30 2000-04-28 用来张开管状组织的斯滕特氏模 Expired - Fee Related CN1239208C (zh)

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