CN101400319A - 用于加强腹主动脉瘤的血管内可输送的扩张器 - Google Patents
用于加强腹主动脉瘤的血管内可输送的扩张器 Download PDFInfo
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Abstract
一种专门设计成用在最小侵入外科手术程序以治疗腹主动脉瘤(AAA)的扩张器/移植物,包括通过编织相对小量的形状记忆合金金属束形成的具有长度(L1)的最里面管状结构。所述最里面管状结构的编织的倾角和纬纱数使得可在管壁上提供相对大的孔。所述最里面管状结构中长度为L2(L2<L1)的部分被另一个编织管状结构围绕,所述另一个管状结构具有相对多的金属束,可阻塞所述最里面管状结构的孔。这样组合的结构可伸展至减小所述扩张器/移植物的外径,使得所述扩张器/移植物能够推入输送导管的空腔。然后,把导管推送通过血管系统到腹主动脉瘤部位,再使所述扩张器/移植物退出,与主动脉瘤桥接的L2部分自膨胀。所述L2部分不会阻碍血液流向肾动脉,而L2部分可以防止主动脉瘤生长和胀破。
Description
技术领域
本发明总体上涉及用于加强血管的血管内可输送的扩张器,更具体地说,涉及为解决腹主动脉瘤(AAA)而专门设计的这样一种扩张器。
发明背景
主动脉瘤是主动脉的一个弱区,主动脉是把血液从心脏送到身体其余部分的主血管。主动脉在胸内从心脏向上延伸然后弯成拱形向下,穿越胸部(胸主动脉)进入腹部(腹主动脉)。腹主动脉的正常直径大约为1英寸。当血液流过主动脉,弱区会鼓起成一个球,如果该球变得太大就会胀破。
大多数情况下,主动脉瘤发生在肾动脉起端以下血管部分。主动脉瘤可延伸至供血给髋部和盆骨的血管。
一旦主动脉瘤的直径到达5cm,一般认为需要对它进行治疗以防止发生胀破。在5cm以下,主动脉瘤胀破的风险比对病人施行常规手术的风险要低。治疗主动脉瘤的目的是防止它们胀破。一旦主动脉瘤胀破,生存的机会变得很小,在所有主动脉瘤发生胀破的病人中有80-90%最终死亡。如果在主动脉瘤胀破之前检测到并加以治疗,可能会避免这些死亡。
大部分主动脉瘤发生在腹主动脉,主要原因是动脉硬化。这种情况是脂肪积聚物粘附在动脉壁上,导致动脉弹性较小,因而变弱。动脉硬化的主要风险因素是吸烟、高血压和遗传因素。
当发生腹主动脉瘤时,可由它们的症状诊断出来,但这通常已经太迟了。主动脉瘤一般在例行身体检查和做胸腹X射线检查时被发现。检查时,医生可能感觉到腹部有肿块。如果医生怀疑是主动脉瘤,他/她可能要求进行超声波扫描。也可以施行其它扫描,如计算机断层造影(CT)和磁共振造影(MRI)。这些扫描技术对于确定主动脉瘤的准确位置十分有用。
治疗腹主动脉瘤的手术过程包括用合成移植物替换主动脉的患部,所述合成移植物通常包括由与正常健康主动脉的性质非常相似的弹性材料制成的一根管。这种重要手术往往相当成功,死亡率只有2-5%。主动脉瘤胀破引起的死亡风险约50%,在手术中甚至更高。最近,血管外科医生并不对主动脉瘤修复进行开放手术,反而安装血管内扩张器/移植物,利用细长形导管旋转穿过病人血管把扩张器/移植物送到主动脉瘤部位。通常,外科医生在病人腹股沟处切开一个小口,然后把含有可伸缩的自膨胀的或充气膨胀的扩张器/移植物的可输送导管送至与主动脉瘤桥接的位置,在该位置点上扩张器/移植物从可输送导管的远端出来,并被允许或使得膨胀至大约是该位置主动脉的正常直径。当然,扩张器/移植物是一个管状结构,可让血液流过其空腔,并可消除主动脉瘤的压力。扩张器/移植物随着时间内皮化,在扩张器外壁与主动脉瘤之间的空间最后被凝血块填塞。此时,主动脉瘤不再承受主动脉压力,因此不再继续生长。
治疗腹主动脉瘤时,最重要的是扩张器准确定位,以便不会阻塞血液流过腹主动脉旁支肾动脉。
Amplatz等人的美国专利6,932,837描述了一种可伸缩的扩张器/移植物,专门用于移植选定血管或其它管状器官的空腔。该扩张器/移植物包括由多束形状记忆合金制成的织造或编织的织物。该织物做成一根管,每端都是开口,让液体流过其中。该装置可以纵向伸展,这样可以减小它的直径,使得它可以插入在可输送导管的腔内。当从可输送导管远端退出时,扩张器/移植物可以自膨胀至预定的外径,足以与待治疗的管状血管壁接合。
该美国专利6,932,837的装置适合用作冠状动脉扩张器,它就不适合用于血管内治疗腹主动脉瘤。这种装置是均匀编织,但必然地它的金属密度不足以限制主动脉瘤接触到主动脉血压。如果该扩张器/移植物也侵入肾动脉的开口,肯定不适当地限制血液流去肾脏。
因此,有需要提供一种治疗腹主动脉瘤的扩张器/移植物,它可以利用血管内方法放置,但又不会不适当地阻塞血液流去肾脏。本发明正是提供这样一种装置。
发明内容
本发明提供一种治疗腹主动脉瘤的可经导管输送的血管内扩张器,包括具有第一长度的最里面管状结构。它包括由多条形状记忆合金制成的编织金属束。编织的倾角和纬纱数选择得所限定的开口足够大,以致于不会实质阻碍血液流过最里面管状结构的壁。围绕最里面管状结构至少还有另一个具有预定直径的管状结构,该另一个管状结构的长度小于所述最里面管状结构的长度。所述另一个管状结构也包括多条编织金属束,其数目比组成所述最里面管状结构的编织金属束数目多。所述另一个编织的管状结构的金属束也包括形状记忆合金,其编织的倾角和纬纱数所限定的开口要足够小,以便基本上阻止血液流过其中。同轴放置的所述最里面管状结构和所述另一个管状结构纵向伸展可减小所述扩张器的外径,足够使得它装入一血管内输送导管的空腔。扩张器从输送导管退出来后,允许它的外径扩张回到由主动脉壁限制的原来的预定直径。
当所述另一个管状结构与腹主动脉瘤桥接时,最里面管状结构延伸超过所述另一个管状结构远端的部分可覆盖病人肾动脉与他/她的腹主动脉的连接处,但没有阻塞血液流去肾脏。
附图说明
结合以下优选实施例的详细描述,特别是当与附图一起考虑时,本发明的上述特征、目的和优点对本领域技术人员会更清楚。
图1所示是放在病人腹主动脉并与主动脉瘤桥接的本发明的扩张器/移植物的侧视图,其中腹主动脉以剖面图表示,不致与扩张器/移植物混淆。
具体实施方式
参看图1,图中示出了本发明优选实施例的扩张器/移植物,以附图标记10表示。扩张器/移植物10置于具有动脉瘤14的腹主动脉12的一段。腹主动脉12的下端分支成左右骼总动脉16和18。图1也示出了连接到肾(未示出)的肾动脉20和22。
扩张器/移植物10包括具有第一长度(L1)的最里面管状结构23。所述最里面管状结构包括多条第一编织金属束24,优选由形状记忆合金制成。组成所述最里面管状结构23的编织物具有预定的倾角和纬纱数,它们限定的贯穿该结构的开口要足够大,以便不会实质阻碍血液流过它的有孔壁。金属束的直径可以在0.002至0.010英时范围内,最里面管状结构23设计成提供给扩张器/移植物10自膨胀所需的足够径向向外的力。
至少一个具有预定直径的另一个管状结构26与具有预定长度(L2)的所述最里面管状结构的部分同轴放置,并且围绕所述部分,其中所述另一个管状结构26的长度比所述最里面管状结构23的长度小。
围绕所述最里面管状结构的所述另一个管状结构由多条第二编织金属束28组成,其数目比组成所述最里面管状结构的多条第一编织金属束的数目多。金属束28也是由形状记忆合金制成,它们编织得到倾角和纬纱数,这些倾角和纬纱数限定的开口要足够小,以便基本上阻止血液流过它们的壁。
不起限制作用地,所述最里面管状结构23可以包括直径为0.005的36束交织金属线,其孔面积约0.0016平方英时(0.040 X 0.040平方英时)。所述另一个管结构26可以包括由形状记忆合金如镍钛诺(Nitinol)形成的144束金属线,它们编织成极其小的孔,这些孔小到可以基本上阻止血液流过扩张器/移植物长度为L2的部分。
根据本发明,由第二最外面管状编织结构30同轴围绕中间管状结构26,后者则围绕最里面管状结构23,这样沿着长度L2也可以提供更加小的孔。该第二最外面管状结构30也可延伸超过长度L2,其编织构造可以与所述另一个管状结构26相同,例如由直径为0.001英时的144束交织镍钛诺金属线组成,开孔的面积是0.0001(0.010 X 0.010)平方英时。
可以考虑的是,采用Curtis Amplatz的美国专利6,123,715描述的方法制造扩张器/移植物10,该专利的全部内容纳入作为参考。最里面结构23可以被编织形成一个管状织物,所述另一个管状结构26也一样。然后,把外面编织管与所述最里面管状结构同心放置,组合后绕一圆柱形心轴放置,该心轴的外径对扩张器/移植物是理想的。接着,把该组合件加热至预定温度并保持一段时间,加热时间要足够管状结构设置成心轴的直径。组成最里面管状结构23的金属束的相对自由端32,34可以做成喇叭状,径向向外10°至30°,由此改善与主动脉内壁的对合。两个或以上同轴编织管从模子取出后,可以用一些聚酯缝线结合在一起。
使用时,这样形成的扩张器的近端可释放地固定在推送导管上,固定的方式如共同待审批的Amplatz在2005年5月4日提交的专利申请序列号11/121,386,发明名称为“用于可受控制的扩张器和移植物的系统”。然后,把扩张器推入血管内输送导管的空腔内。再用已知的Seldinger技术把该输送导管导入病人体内,再旋转通过血管系统直至输送导管的远端接近要治疗的主动脉瘤。扩张器和推送导管固定在一起,输送导管沿近端方向牵拉,以使扩张器从该输送导管的远端退出,在所述远端扩张器自膨胀至与图1中长度L2的那部分的主动脉壁接合,所述那部分与要治疗的主动脉瘤桥接。最里面管状结构延伸超过所述另一个管状结构远端的那部分可覆盖肾动脉20和22的开口。不过,最里面管状结构的那部分的开孔编织构造使得它不会明显阻塞血液流去肾动脉或造成狭窄。最里面管状结构23延伸超过所述其它层26,30的远端而使扩张器/移植器10获得的附加长度,可用来更好地把扩张器/移植物稳定在腹主动脉内,防止它在内皮化发生之前移位。
在这里已对本发明作了相当的描述以顺应专利法并为本领域技术人提供了信息,使他们能够实施新原理、构造和使用所例示的实施例。然而,应该懂得,本发明可通过不同的装置和设备来实施,在不脱离本发明范围的情况下,可对例如装置和操作程序作出各种各样的修改。
权利要求书(按照条约第19条的修改)
根据第19条(1)的声明
包含权利要求1-6的替换页8和9用来代替包含权利要求1-7的初始提交页8和9。权利要求包含的修改用于阐明和更加简明地描述本发明。这些权利要求与本申请要求优先权的那个申请的权利要求一致。
权利要求1已经修改为进一步限定管状结构为“金属结构”。权利要求1也已经修改为重新限定小于最里面管状结构的第一长度的预定长度部分为“第二长度”。同时删除了权利要求7。
Fogarty公开了一种腔内假体,所述假体的两端具有远端和/或近端套囊模件。Von Oepen公开了两个轴向扩张器,在所述扩张器之间具有一径向膨胀的材料层。Noble公开了一种用于加强血管壁的血管扩张器。审查员没有给出理由为什么这些对比文件能够以审查员提出的方式组合起来。为什么一个尝试适当地把假体与血管匹配以治疗主动瘤的人会利用Von Oepen公开的扩张器/移植物?这样会产生怎么样可能的有益效果?事实上,Fogarty在背景技术部分(参见Fogarty的说明书第2栏第3-34行)非常清楚地给出与Von Oepen的扩张器/移植物截然不同的教导,而且Von Oepen要求扩张器径向膨胀,而非纵向伸展,可见其教导也与本发明不同。此外,为什么想要把假体与血管匹配以治疗主动脉瘤的任何人都会利用Noble的开口袋和槽道?这些开口袋和槽道可允许血液流动并且会加剧主动脉瘤。Noble要求“开口袋和槽道使用还原性金属”,这样的教导与本发明不同。Noble没有任何教导或提示对治疗主动脉瘤非常关键的限制血流,限制血流能使加强血管的效果更好。所以,Fogarty、VonOepen与Noble综合的结果正好相反。
此外,由审查员提出的这种组合并没有揭示修改后的权利要求1的技术特征“至少一个具有预定直径和第二长度的另一个结构,所述另一个结构围绕着所述最里面结构而放置,所述另一个结构包括多条也是由形状记忆合金制成的第二编织金属束,所述第二编织金属束的数目比所述第一金属束的数目多,所述另一个结构的编织的倾角和纬纱数所限定的开口足够小,以便基本上阻止血液流过其中”。
上述对比文件单独或组合起来没有公开以围绕方式放置的一种最里面金属结构和另一个金属结构,其中多条第二编织金属束的数目比多条第一编织金属束的数目多。因此,这些对比文件组合起来并没有揭示了修改权利要求1的全部特征。所以,权利要求1相对于Fogarty并在VonOepen与Noble的基础上是具有专利性的。
权利要求2至6从属于权利要求1。因此权利要求2至6相对于Fogarty、Von Oepen与Noble的综合教导也是具有专利性的。
权利要求7已经被删除了,因此审查员的意见也不成立了。
我们认为,新提交的修改后的权利要求是在说明书所描述的本发明的范围内,只是使本发明的概念描述得更简明,修改后的权利要求相对于国际检索报告中“Y”类对比文件限定得更明确。
1.一种用于治疗腹主动脉瘤的经导管输送的扩张器,包括:
(a)具有第一长度的最里面金属结构,所述最里面金属结构包括多条由形状记忆合金制成的第一编织金属束,所述最里面金属结构的编织具有预定的倾角和纬纱数,它们限定的开口足够大,以便不会实质阻碍血液流过其中;
(b)至少一个具有预定直径和第二长度的另一个金属结构,所述另一个金属结构围绕着所述最里面金属结构而放置,所述另一个金属结构包括多条也是由形状记忆合金制成的第二编织金属束,所述第二编织金属束的数目比所述第一编织金属束的数目多,所述另一个金属结构的编织的倾角和纬纱数所限定的开口足够小,以便基本上阻止血液流过其中;
(c)其中所述最里面金属结构和所述另一个金属结构的纵向伸展减小所述扩张器的外径,足以使它装入一血管内输送导管的空腔,并使所述扩张器从输送导管退出来,而所述外径扩张回到所述预定的直径。
2.如权利要求1所述的经导管输送的扩张器,其特征在于:当所述另一个金属结构与腹主动脉瘤桥接时,所述最里面金属结构延伸超过所述另一个金属结构端部的一部分适合于覆盖病人肾动脉与腹主动脉的连接处。
3.如权利要求1所述的经导管输送的扩张器,其特征在于:两个另一个金属结构与所述预定长度部分大致地以同轴放置并围绕所述预定长度部分。
5.如权利要求1所述的经导管输送的扩张器,其特征在于:所述多条第一编织金属束包括36束,所述多条第二编织金属束包括144束。
6.如权利要求3所述的经导管输送的扩张器,其特征在于:所述两个另一个金属结构各包括144束编织金属束。
Claims (7)
1.一种用于治疗腹主动脉瘤的经导管输送的扩张器,包括:
(a)具有第一长度的最里面管状结构,所述最里面管状结构包括多条由形状记忆合金制成的第一编织金属束,所述最里面管状结构的编织具有预定的倾角和纬纱数,它们限定的开口足够大,以便不会实质阻碍血液流过其中;
(b)至少一个具有预定直径的另一个管状结构,所述另一个管状结构围绕着所述最里面管状结构的一预定长度部分而放置,所述预定长度部分的长度比所述最里面管状结构的第一长度小,所述另一个管状结构包括多条也是由形状记忆合金制成的第二编织金属束,所述第二编织金属束的数目比所述第一金属束的数目多,所述另一个管状结构的编织的倾角和纬纱数所限定的开口足够小,以便基本上阻止血液流过其中;
(c)其中所述最里面管状结构和所述另一个管状结构的纵向伸展减小所述扩张器的外径,足以使它装入一血管内输送导管的空腔,并使所述扩张器从输送导管退出来,而所述外径扩张回到所述预定的直径。
2.如权利要求1所述的经导管输送的扩张器,其特征在于:当所述另一个管状结构与腹主动脉瘤桥接时,所述最里面管状结构延伸超过所述另一个管状结构端部的那部分适合于覆盖病人肾动脉与腹主动脉的连接处。
3.如权利要求1所述的经导管输送的扩张器,其特征在于:两个另一个管状结构与所述预定长度部分大致地以同轴放置并围绕所述预定长度部分。
5.如权利要求1所述的经导管输送的扩张器,其特征在于:所述多条第一编织金属束包括36束,所述多条第二编织金属束包括144束。
6.如权利要求3所述的经导管输送的扩张器,其特征在于:所述两个另一个管状结构各包括144束编织金属束。
7.一种治疗腹主动脉瘤的方法,所述方法包括以下步骤:
(a)提供权利要求1所述的扩张器;
(b)把所述扩张器的近端可释放地固定在推送导管上
(c)把所述扩张器送入血管内输送导管的空腔;
(d)使所述输送导管向前推进进入血管系统,直至所述输送导管的远端接近要治疗的腹主动脉瘤;以及
(e)用推送导管固定住所述扩张器,同时在近端牵拉所述输送导管以使所述扩张器从所述导管的远端退出,而所述扩张器自膨胀至与主动脉壁接合并桥接所述主动脉瘤;以及
(f)使所述扩张器的近端从所述推送导管释放出来。
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- 2006-11-28 JP JP2008550311A patent/JP4980370B2/ja not_active Expired - Fee Related
- 2006-11-28 BR BRPI0620993-9A patent/BRPI0620993B1/pt not_active IP Right Cessation
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
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CN111093561A (zh) * | 2017-07-07 | 2020-05-01 | 恩朵罗杰克斯股份有限公司 | 血管内移植物系统和用于部署在主要动脉和分支动脉中的方法 |
CN108652787A (zh) * | 2018-05-06 | 2018-10-16 | 王潇 | 用于腹主动脉瘤修复的覆膜支架及其使用方法 |
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JP4980370B2 (ja) | 2012-07-18 |
WO2007087005B1 (en) | 2008-09-18 |
WO2007087005A3 (en) | 2008-06-12 |
US8900287B2 (en) | 2014-12-02 |
BRPI0620993A2 (pt) | 2011-11-29 |
BRPI0620993B1 (pt) | 2018-07-10 |
US20070168018A1 (en) | 2007-07-19 |
WO2007087005A2 (en) | 2007-08-02 |
EP2001403A2 (en) | 2008-12-17 |
EP2001403A4 (en) | 2015-07-15 |
CN101400319B (zh) | 2012-08-22 |
EP2001403B1 (en) | 2017-01-04 |
JP2009523482A (ja) | 2009-06-25 |
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