CN1216929A - 用于阻塞通过血管的流动的方法与装置 - Google Patents

用于阻塞通过血管的流动的方法与装置 Download PDF

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Publication number
CN1216929A
CN1216929A CN97193313A CN97193313A CN1216929A CN 1216929 A CN1216929 A CN 1216929A CN 97193313 A CN97193313 A CN 97193313A CN 97193313 A CN97193313 A CN 97193313A CN 1216929 A CN1216929 A CN 1216929A
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Prior art keywords
blood vessel
chamber
shape
blood
lumen
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CN97193313A
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Inventor
P·C·伊瓦德
J·C·弗拉赫蒂
J·T·加里博托
P·E·麦考莱
T·R·马肖德
J·马科韦
J·B·惠特
M·詹森
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Transvascular Inc
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Transvascular Inc
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Priority claimed from US08/730,496 external-priority patent/US5830222A/en
Priority claimed from US08/730,327 external-priority patent/US6190353B1/en
Application filed by Transvascular Inc filed Critical Transvascular Inc
Publication of CN1216929A publication Critical patent/CN1216929A/zh
Pending legal-status Critical Current

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Abstract

本发明为用于阻塞一根血管(22)中血流的方法与装置。在第一个实施方案系列中,本发明包括许多通过传统的导管(10)的腔(12)进行配置的栓塞装置(16),在配置后能使所说的栓塞装置(16)在血管(22)腔内的特定部位保持固定并阻塞血流。这些栓塞装置(16)或是嵌入或压在血管腔上的机械栓塞装置或是可以在指定部位阻塞血流的化学的血管-阻塞介质。本发明的第二个实施方案包括使用一种真空/烧灼装置,该装置可以在装置周围的血管腔内进行抽吸,使血管保持为闭合的状态,而后原位利用足够的能量使装置周围的组织收缩从而变性成为一个闭塞物。在第三个实施方案系列中,本发明包括一种栓塞强化物和利用能量强制力的联合,以便在血管内的特定部位形成腔内闭塞物。

Description

用于阻塞通过血管的流动的方法与装置
相关申请
本专利申请要求对于1996年2月2日申请的美国临时专利申请序列第60/010,614号的优先权,同时本申请为共同未决的美国专利申请:1996年10月11日申请的08/730,327和1996年10月11日申请的08/730,496的部分-继续申请,每个这些相关申请的所有公开的内容在这里都清楚地被引入参考文献。
发明领域
本发明一般地涉及医疗装置,特别涉及用于阻塞或封闭血管或其它解剖学通道的腔的方法与装置。
发明背景
在现代的医疗实践中,常需要阻塞或以其它方式防止通过血管或其它解剖学通道的腔的流动。需要阻塞血管腔的医疗操作的例子包括:a)用以降低或阻塞血液流入血管的动脉瘤(例如,脑动脉瘤)的操作;b)用以阻塞由一个外周静脉段发散出的侧枝,为原位分流通道准备静脉区段的操作;c)用以治疗曲张的静脉的操作;d)如在美国专利申请序列第08/730,327号和第08/730,496号所描述的用以对受阻的,患病的或受损的动脉进行分流的贯通血管的,基于-导管的操作;e)用以阻塞或降低血液流入肿瘤的操作;f)用以封闭先天的或后天的动-静脉的畸形的操作;和g)作为用于治疗动脉瘤或其它治疗性介入置入一个血管内移植物的辅助,临时地或永久地阻塞通过一个血管的血流的操作。
用于阻塞某些血管腔的栓塞装置的例子在下述的美国专利中有所描述:第5,382,260号,Dormandy,Jr.et al.;第5,342,394号,Matsuno et al.;第5,108,407号,Geremia et al.;第4,994,069号,Richart et al.;第5,382,261号,Palmaz;第5,486,193号,Bourne et al.;第5,499,995号,Teirstain;第5,578,074号,Mirigian;以及专利合作条约国际公开号WO96/00034,Palermo。
在共同未决的专利申请第08/730,327和08/730,496号中所描述的经血管的基于-导管的分流新方法包括某种冠状动脉分流技术,在该项技术中,推进一个可进入组织的导管,穿过腔体,进入冠状血管系统并用以在受阻的冠状动脉和相邻的冠状静脉之间,在动脉阻塞的上游部位形成至少一个血流通道(例如,一个穿刺通道或间质的管道)。于是动脉血液将由受阻的冠状动脉流入相邻的冠状静脉。紧接着在靠近第一血流通道处阻塞或封闭冠状静脉腔强迫进入静脉的动脉血通过静脉沿逆方向流动。这时,受阻的动脉血将经过冠状静脉逆向大量地进入心肌。或者,可选择地,在分流入动脉血的冠状静脉和受阻的动脉或其它冠状动脉之间形成一个或多个二次血流通道(例如,穿刺通道或间质管道),以使动脉血在动脉阻塞处分流以后重新-进入冠状动脉树。在冠状静脉和一个或多个相邻的动脉之间形成这些二次血流通道的情况下,可将冠状静脉的腔在这些二次通道的远侧阻塞或封闭,以便于分流的动脉血重新-进入冠状动脉循环。这种经血管的基于-导管的冠状动脉分流技术提出了涉及栓塞装置类型的独特的和至今难于解决的问题,所说的栓塞装置是用以在操作的过程中形成的动-静脉血流通道(例如,穿刺通道或间质管道)的近端和/或远端处阻塞冠状静脉腔。特别是,当动脉血通过冠状大静脉近端区段分流时这通常要求在或靠近其由冠状静脉窦的汇合点处阻塞冠状大静脉腔。冠状大静脉的该近端区段为锥形或有角度的,因而使用传统的用于栓塞或阻塞血管或动脉瘤所限定的空间一类的栓塞线圈是不合适的,这是由于冠状大静脉近端区段渐变的锥形或扩展的构造可使栓塞线圈移位或松动。
因此,需要在该项技术中开发新的方法与装置,用以阻塞或以其它方式封闭血管或其它解剖学通道的腔,而这些方法和装置是可以用于血管的锥形(即,扩展的)区段(例如,冠状大静脉的近端)和/或在置入后是可以移动的和/或在置入后可以刺穿或横切的。
发明概述
本发明提供了用于阻塞或封闭血管腔以阻止其间的血液流动的方法与装置。本发明的装置较已有技术具有某些优点,诸如ⅰ)置入后的可移动性,和/或ⅱ)置入后的可刺穿性或可再穿越性,和/或ⅲ)可以对血管腔的锥形的或扩展的区域(例如,冠状大静脉的近端部分)的血流提供基本上是即时的和永久的阻塞。
本发明的装置一般地属于两个主要的范畴--ⅰ)可置入的腔-阻塞装置,和ⅱ)可用于熔合或以其它方式使血管腔壁收缩从而形成一个封闭的形状或收缩到已经置入血管腔内的部件上的装置。可置入的腔阻塞装置
本发明的可置入的腔阻塞装置一般包括ⅰ)一个血管啮合部分,该部分可将装置锚固在血管周围的壁上,和ⅱ)一个腔阻塞部分,该部分至少可在一个方向上阻止通过血管腔的血流。
按照本发明,这些可置入的腔阻塞装置在开始时配置成径向压紧的形状以便于其通过血管系统的贯穿腔体的投送(例如,在一个投送导管内或其它投送工具内)。在到达所需要的置入部位后,这些腔阻塞装置可径向膨胀成为工作形状,其中装置的血管啮合部分将与血管壁啮合,而装置的腔阻塞部分将阻塞血管腔以至少在一个方向上阻止血液的流动。
再根据本发明,装置的血管啮合部分可包括一个线材或其它适合的材料制成的结构构架。装置的腔-阻塞部分可包括一个膜,海绵体,织物板,塞子,盘或其它大小可横向放置在血管腔中以阻塞血流的部件。
仍旧根据本发明,装置的血管啮合部分可以包括许多由一个支点向外放射状伸出的部件,当压力作用在支点上时,所作用的压力将使这些部件向外偏移从而径向膨胀,扩大或向外施加压力于血管壁,进而阻止了装置由其在血管中放置的位置上的移动或偏移。
再根据本发明,这些可置入的腔阻塞装置可以带有X射线照相可见的材料以便在置入后使X射线照相能够看到腔阻塞装置。
仍旧根据本发明,这些可置入的腔阻塞装置可以包括弹性的或形状记忆材料,这些材料可通过其自身的回弹力或当暴露在体温下因升温产生形态转换时由工作形状而自-膨胀。另外,这些可置入的腔阻塞装置可以包括塑性变形材料,这些材料在压力或力的作用下可由其径向压紧的形状变形为其工作形状。这些塑性变形的实施方案在开始时可连接在配置有施加向外的压力的工具(例如,气囊或其它机械装置)的投送导管上,在装置被放置在血管内其所需要的位置上以后,施加压力的工具可使装置塑性变形为其径向膨胀的形状,其中,装置的啮合部分将与血管壁啮合。另外,某些这样的装置是可膨胀的,可由其径向压紧的形状膨胀到其工作时的形状。
仍旧根据本发明,至少可置入的腔阻塞装置的某些实施方案在置入血管腔以后是可移动的。可借以实现这种移动的装置可以包括一个连接器或其它配件,部件以便于联系或连接到一个导线,导管或其它回收装置,以便拉,拉回,收回,抽出,吸出或以其它方式移动已放入导管腔内或其它可移动的运载工具内由身体中移出装置。或者,在装置的血管啮合部分是由形状记忆合金制作的实施方案中,对置入的装置可以进行原位处理以使其径向缩紧。这种原位处理可以包括注入冷却的液体(如盐水)使装置的形状记忆合金由一种结晶状态转换为另一种,与此同时装置由其工作形状径向收缩为便于抽出和移动的径向更为紧缩的形状。
仍旧根据本发明,可置入的腔阻塞装置的某些实施方案可以包括一个可再穿越的(即,可刺穿的)腔阻塞部分。在这种情况下,一个针或其它穿刺元件可在装置置入后穿过装置以恢复血流,或者在装置置入部位的远端在血管部分上开口。
仍旧根据本发明,这些可置入的腔阻塞装置的某些实施方案可以包括纺织品或其它质地可渗透的材料,这些材料可以承受细胞向内生长或内皮愈合。在这些实施方案中,细胞向内生长或内皮愈合可用以增强装置在血管腔内的锚固和/或改善装置在置入后长期的生物相容性。腔熔合装置
本发明还包括用以使血管腔熔合的装置。根据本发明的这些实施方案,提供了具有至少一个抽吸部分和至少一个能量-发射区的可插入腔内的装置。通过抽吸部分进行抽吸使血管腔在靠近装置的能量-发射区处凹陷。随后,由能量-发射区发出能量以熔合,烧灼或以其它方式融合凹陷的血管腔壁,从而在该部位将血管腔封闭。作为使用发射能量方法的一种代替,这些装置可以投送一种能够粘结或化学融合血管腔的粘结剂或其它化学物质以形成所需要的腔的封闭。
再根据本发明的这一实施方案,提供了一种可插入腔内的装置,该装置具有一个在其上形成的气囊,一个液体投送部分,和一个能量发射区。气囊被充气后,气囊将暂时地阻塞血管。随后,通过液体投送部分将一种可流动的导电介质(例如,盐溶液)送入血管腔靠近能量发射区的部位。然后发射能量使能量通过预先注入的导电介质传送到血管壁,导致血管壁的缩小或收缩从而在该部位形成血管腔的封闭。
仍旧根据本发明的这一方面,提供了配有一个芯或栓塞部件的腔内装置,所说的芯或栓塞部件的直径小于血管腔的直径。这种装置随后发出射频能量或其它能量使血管壁在预先置入的芯或栓塞部件附近缩小或收缩。随后,抽出装置,将牢固地置入血管缩小或收缩区域的芯或栓塞部件留在那里,从而在该部位将血管封闭。
对于熟悉此项技术的人来讲,在阅读并理解了以下关于优选实施方案的详细描述和在研究了示出优选实施方案和实施例的附图以后,本发明的进一步的目标和优点是显而易见的。
附图简述
图1为根据本发明用于向血管内配置某种栓塞装置的导管的侧视图;
图2为沿图1中线2-2截取的部分剖面图;
图3为图1中导管的部分纵向剖面图,该导管用于在两个相邻的血管中的一个相应血管内配置两个栓塞装置中的第二个(2),在这两个血管上具有由两个吻合连接在其上形成的一个血流通道;
图3a为根据本发明的一个优选实施方案的一个水母-型栓塞装置的透视图;
图4为根据本发明的另一个实施方案的图3a的水母-型栓塞装置的透视图;
图5为根据本发明的优选实施方案的正弦曲线的线-型栓塞装置的透视图;
图5a为根据本发明的另一个优选实施方案的正弦曲线的线-型栓塞装置的透视图;
图5b为根据本发明的另一个优选实施方案的正弦曲线的线-型栓塞装置的透视图;
图6为根据本发明的一个优选实施方案的一个鸟笼-型栓塞装置;
图6a为鸟笼-型栓塞装置另一个优选实施方案的透视图;
图6b为鸟笼-型栓塞装置另一个优选实施方案的透视图;
图7为根据本发明的一个优选实施方案的伞-型栓塞装置的透视图;
图8为根据本发明的一个优选实施方案的杯-型栓塞装置的透视图;
图9a为根据本发明的一个优选实施方案的一个可穿越-型栓塞装置的透视图,所说的装置采取的是第一关闭位置;
图9b为采取第二开放位置的图9a中的可穿越-型栓塞装置的透视图;
图10为根据本发明的一个优选实施方案的一个隔膜-型栓塞装置的透视图;
图11为根据本发明的一个优选实施方案的一个帽盖线圈-型栓塞装置的透视图;
图12a为根据本发明的一个优选实施方案的一个环状塞-型栓塞装置的剖面视图,所说的环状塞装置在一个血管腔内采取的是第一非膨胀状态;
图12b为图12a中的环状塞-型栓塞装置在血管腔内采取第二膨胀状态时的剖面视图;
图13a为根据本发明的一个优选实施方案的一个膨胀的斯滕特固定模/袋-型栓塞装置的剖面视图,所说的膨胀的斯滕特固定模/袋在血管腔内采取的是第一伸长的位置;
图13b为图13a中的膨胀的斯滕特固定模/袋在所说的腔内采取第二倒置状态的剖面视图;
图14为根据本发明的一个优选实施方案的一个位于血管腔内的钩状塞-型栓塞装置的剖面视图;
图15为根据本发明的一个优选实施方案的一个位于血管腔内的覆盖着的球状线圈-型栓塞装置的剖面视图;
图16为根据本发明的一个优选实施方案的一个位于血管腔内的计时沙漏-型栓塞装置的剖面视图;
图17为根据第一优选实施方案的可移动的气囊-型栓塞装置的剖面视图;
图18为根据第二优选实施方案的可移动的气囊-型栓塞装置的剖面视图;
图19为根据本发明的一个优选实施方案的置入血管腔内的一个探测器/填料器-型的栓塞装置的剖面视图;
图20为根据本发明的一个优选实施方案的置入血管腔内的一个三-向阀斯滕特固定模栓塞装置的透视图;
图21为根据本发明的一个优选实施方案的正在置入血管腔内的一种栓塞形成介质的剖面视图;
图22为根据本发明的一个优选实施方案的用于阻塞血管内血液流动的一个系统的透视图;
图23为根据本发明的一个优选实施方案中的用于阻塞血管内血液流动的一个装置的远端的透视图;
图24为置入血管纵剖面内的图23中的装置的远端的剖面视图;
图25为图23中的装置正在用以在腔内抽拉围绕着装置远端的血管壁时其远端的剖面视图;
图26为图23中的装置正在用以在血管内形成腔内闭塞物时装置的剖面视图;
图27为一个正在用以向血管腔内放置一块自体组织的一根导管的远端的剖面视图;
图28为置入血管腔内的一束导线栓塞绞线的剖面视图,栓塞绞线带有表示将由其上引出的外接地线;
图29a为置入血管腔的一个带纹理的电极塞的剖面视图,血管腔内具有一个绝缘的导电导线在其中延伸;
图29b为正在熔合血管腔的图29a中的电极塞的剖面视图,所说的电极塞通过导电的导线与一个能源相连接;
图30为正在用以对血管腔内的一种导电介质进行熔合的一个导管远端的剖面视图,所说的导管的远端具有一个由其中伸出的绝缘电极和一个取膨胀形态的位于所说的远端的近端一侧的气囊;和
图30a表示在其中形成腔内封闭的一段血管的剖面视图。
优选实施方案的详述
现在参照附图,并从图1-21开始,图中示出了用于在血管系统内所需要的位置上在血管内阻塞血流的方法和装置。在这里所公开的方法和装置对于迅速地,如果不是立即地,阻塞诸如冠状大静脉等血管-阻塞特别困难的具有锥形腔或扩展腔的血管内的血流是特别适合的。同样,这里公开的方法和装置可以理想地设计成能够承受动-静脉血压的差异和波动从而在所需要的部位在较长的时间内,如果不是无限的,阻塞血流。
这需要实现血管-阻塞特别是在某些原位分流技术中的血管-阻塞,这时在两个位于相邻位置的血管之间(例如,在一个堵塞的冠状动脉和相邻的冠状静脉之间)形成血流通道以分流一个血管的病变的,受损的或受阻的区段,如图3所示,并在美国专利申请序列第08/730,327号和第08/730,496号已有所描述,其有关技术在这里都清楚地引入参考文献。如所示,为使血流18改道绕过血管22中的一个病变的或受阻的区段20,需要使血流18改道进入血流从中发出的血管22。为保证血流18在由受阻处分流后,重新进入受阻的血管22,或进入某些其它血管,很明显,血流18得以通过其进行改道的相邻的血管24应在改道的血流18的上游和下游进行充分的血管阻塞。
尽管已有的技术具有各种形成栓塞的装置,诸如螺旋形线圈,气囊导管,和类似物,但这些栓塞装置在置入欲栓塞的部位后不能回收、穿越,不具增强的保持装置固定在血管系统内并抵抗动-静脉血压差(特别是在管腔具有扩展部分的情况下)从而避免移动的能力。在这一方面,这些已有技术的形成栓塞的装置,其中最值得注意的是螺旋形线圈和化学阻塞介质,在腔是扩展的情况下,一般在需要阻塞的腔的扩展部分保持长时间阻塞的大小和适应性上都是不够的,连同作用在装置上的连续的不均匀的动-静脉血压都导致装置由其置入的位置上移开。
另外,这种已有技术的栓塞装置的缺点在于难以设计成通过投送导管腔前进和置入。在这一方面,这些栓塞装置必须是可以被压缩的或以其它方式缩小尺寸以便通过导管腔前进和随后能够采取足以阻塞血流的膨胀的位置。这些装置,诸如在美国专利第5,499,995号,Teirstein所描述的,既未能实现充分压缩的状态以便于通过导管腔进行置入,另一方面,一旦通过导管置入以后又未能采取一种既能阻塞血流,又能保持牢固地定位于血管腔内所需的置入部位的充分膨胀或血管-阻塞的形状。
在图2-21中所示的和这里将进一步讨论的第一实施方案系列中,示出了许多栓塞装置和阻塞介质,这些装置和介质的设计和构成应能利用一个传统的导管10置入血管系统中需要阻塞的部位,如图1所示。如在此项技术中所熟知的,该导管10具有一个在其中形成的腔12,这里公开的栓塞装置通过导管可以置入在需要的部位。在这一方面,栓塞装置16,诸如在图2中所述的一种,被放入导管腔12中并利用一个推杆26在其中前进,如在图3中更为清楚地示出的。一旦导管10的远端14到达需要阻塞的部位,栓塞装置16通过导管10的远端14的腔12前进并保持在这里。
在这里公开的每个实施方案所共有的优点是每个这类装置都比较容易配置,特别是易于通过导管10的腔12进行投送;能够抵抗移位并能保持更为牢固地定位于或固定在需要血管-阻塞的部位;带有可以再穿越的装置从而可在以后通过其进行另外的操作;或带有在以后可以使装置收回的部件,典型地是通过一个导管。进一步有利的是使这类栓塞装置保持射线不能透过从而可以高度精确地确定装置的位置,特别是装置的置入。正如熟悉此项技术的人所认识到的,这些性能为医生提供了提高在患者血管系统特定的部位实施重大血管一阻塞操作的能力,以及在以后的操作需要时能够在将来接近或收回该装置。
关于这类栓塞装置的第一个,在图2,3,和3a示出一个水母-型栓塞装置16,装置包括一个织物,复合材料,编织物或聚合物顶盖16a,和一个顶盖放置在其上的柱状线材结构或构架16b的组合物。织物或聚合物顶盖16a优选由一种薄的,可拉伸的材料制成,诸如硅酮,尿烷,聚乙烯,聚四氟乙烯,尼龙,Carbothane,Tecoflex,Tecothane,Teco,或其它熟悉此项技术的人所熟知的类似材料。织物或聚合物顶盖16a可进一步做成带纹的或粗糙的以帮助顶盖16a的内皮愈合,和进一步可优选用包括聚酯,尼龙,涤纶,ePFTE和类似材料的织物加强,这可以压铸在顶盖16a中或暴露在其表面上。另外,这种加强的织物可以覆盖整个聚合物顶盖16a或策略地布置以防顶盖16a磨损。例如,这些织物可用以将顶盖绑结在柱状线材结构16b上。
柱状结构16b优选用一种有展延性的,射线透不过的和生物相容的材料制成,例如镍钛线材,钽,不锈钢,铂,金,钨,镀钨的,钛,MP35M EIgioy,以及这些金属的其它合金和类似物,并优选形成具有曲折的形状。柱状结构16b的构成还进一步能使结构可以如图2和3所示的第一种压缩的状态存在,以便通过导管10的腔12进行配置,和在需要栓塞的部位由导管10的远端14被推出时采取第二种膨胀的位置,如图3和3a中所示。如熟悉此项技术的人所认识到的,由于使用热膨胀或超弹性材料诸如镍钛诺制作柱状结构16b,使栓塞装置16可以采取一种矮小的形状以便于通过配置导管10的腔12进行投送。为进一步增强装置16采取这种矮小形状的能力,构成柱状结构16b的线材可形成附加的向着其自身的压力以使结构的直径大大地缩小。同样,这种材料有利于使装置16采取一种膨胀的形状从而便于在血管24中进行血管一阻塞。在这一方面,装置16的形成应优选使弹性顶盖16a仅围绕柱状部分16b远端的约二分之一到三分之一上形成,从而在装置已置入并允许采取膨胀形状时使柱16b的自由端在血管24的腔周围充分地膨胀。
为进一步便于柱状部分16b在膨胀形状时能够附着在血管24的腔上,柱状结构16b可具有在其上形成的弯曲形状以增强结构16b和血管24的腔的摩擦啮合。如应看到的,为达到最优的血管-阻塞效果,栓塞装置16的配置应使膜16a面对血液18的迎面的流动。由于面向血液18流动的迎面,血液的压力实际上使装置16易于在血管24的腔内保持固定在需要的位置上。在这一方面,柱状结构16b的自由的未覆盖的部分没有收缩或受到采取完全膨胀的形状的限制。事实上,如图3a所示,柱状结构16b的自由端可以做成向外弯曲的形状从而在血管-阻塞的部位嵌入腔壁上。
如所看出的,形成栓塞的装置16在以膨胀的状态位于血管的腔24内时,其方向使弹性体织物或聚合物顶盖16a产生一个限制通过血管的血流的血管-阻塞面。无论如何,在以后需要实行某种操作时,织物或聚合物顶盖16a进一步提供用以再穿越接近血管-阻塞部位的装置是有利的。在这一方面,一个导管,例如,可以沿轴向前进穿过由弹性体顶盖16a形成的鼓-状阻塞挡层而没有改变柱状结构16b保持轴向地固定在血管腔的周围的能力。同样,借助于用热收缩材料制作柱状结构16b,利用暴露结构16b以降低温度使柱状结构10b采取收缩的形状使其能够退回导管10的腔12中,从而可以使装置16很容易地通过导管10的腔12取出。
参照图4,5,和6,其中示出了根据本发明的水母-型栓塞装置的另外的实施方案。参照图4,图中示出了一个由许多沿纵向延伸的线材28b组成的栓塞装置28,这些线材在一端通过焊接或一个外套管而连接在一起。织物或聚合物顶盖28a放置在沿纵向延伸的线材28b远端的约三分之一到二分之一的部分上,以便在置入时弹性体顶盖28a可沿径向膨胀形成一个血管-阻塞面。如所看出的,沿纵向延伸的线材28b,借助于它的布置,适宜于径向嵌入血管腔,并且在受阻血流作用于织物或聚合物顶盖28a上的较大的压力下,实际上增强了装置28牢固地固定在血管-阻塞部位的能力。另外,应予指出,沿纵向延伸的线材28b的这种布置在以后需要时可便于收缩使装置28能够通过导管腔收回。为加强这种收回的能力,该装置可进一步优选包括一个在连接细长线材28b的焊接处形成的环部件(未示出),因而提供了箍住装置的部件并可通过导管腔收回装置,以便在需要时移去装置并恢复通过血管-阻塞的血管的血流。
图5还描述了该第一类栓塞装置的另一个实施方案30,其中柱状结构30b由取正弦曲线形状的回旋线材组成。所示的柱状结构30b全部为弹性体顶盖30a所覆盖,从而在置入后柱状结构30b膨胀时,导致弹性体顶盖30a相应地围绕血管腔沿径向膨胀,从而阻塞了通过其中的血流。用弹性体包层30a完全覆盖住柱状结构30b,有利地实现了血管-阻塞的最大阻塞效果。
在一个优选实施方案中,图5中描述的缠绕线材30b的形状取为一种曲折的形状30c,如图5a所示。如所示,线材结构由一连串连续的直线部分30d所组成,在顶点刚性连接形成曲折的结构,其中在压缩的状态,应力储存在装置的直线部分30d中,因而使接合点/顶点处的应力降至最低并允许在矮小的形态下的投送。
在另一个优选实施方案中,图5和5a所示的线材结构30b,30c的形状可以制成截-锥形的结构30d,如图5b所示。该实施方案在置入时应使装置的狭窄端放置在血流的方向使扩展端可以更充分地膨胀从而向血管腔周围传递更大的轴向压力。
现在参看图6,图中示出了另一个根据本发明的优选实施方案的鸟笼-型栓塞装置32,装置由许多沿纵向延伸的线材形成一个柱状结构32b,在两端用焊接头或一个外套管连接使柱的中央部分向外弓从而形成一个球茎的形状。弹性体顶盖32a放置在装置32相应的一端从而在置入血管腔以后阻塞血流。在该实施方案的变型中,柱状部分32b的构成使结构的端部32c’,32c”沿轴向在两端向结构内翻转,如图6a所示。这种形状将在置入和随后对血管的伤害降至最低限度。在另一个实施方案中,如图6b所示,栓塞装置的构成应使结构32b的中央部分被压缩形成直线部分32d,并在结构32b的相对的端部形成球茎形结构32e’,32e”。这种形状由于两个球茎结构32e’,32e”对血管壁提供了较大的并置造成围绕血管腔轴向接触。
参照图7,图中示出了根据本发明一个优选实施方案的伞-型栓塞装置34。该装置与前述的水母-型阻塞栓相似,包括一个由纵向延伸的线材34b形成的网,其上围绕着一个弹性织物或聚合物顶盖34a。根据该实施方案的线材34b,被向外地铰接起来迫使这些线材向外成为较大的直径。这样,装置34可以很容易地采取第一压缩位置,可以通过导管前进以便进行配置,和随后可膨胀成为第二状态,使线材围绕血管腔径向向外弹出。借助于栓塞装置34在血管中的取向,应该看出血液向着装置34的流动实际上帮助了装置34固定在血管内的能力。作为一种选择,装置34还可装备一个抓取环,以使装置在以后需要被移出时能够收回装置。
图8描述了根据本发明一个优选实施方案的杯-型栓塞装置36。该装置36包括至少两个自-膨胀线材结构36a,36b,线材结构基本上在其相应的中-点弯曲并相交在所说的弯曲处,优选形成一个90°角,尽管其它的角度也是可行的。装置36用一种移植物或其它微孔性的薄膜36c覆盖,以便在置入后,移植的微孔薄膜36c使血液易于和加强凝块的形成从而阻塞血流。如所看到的,自-膨胀的线材结构36a,36b提供了基本上为径向的力以便在血管内固定装置。另外,该装置36具有可便于压缩的优点,从而使装置可以通过导管腔前进和进行配置。该装置36还具有能够收回的优点,很象上述的伞-型栓塞装置,就线材结构36a,36b的交点来讲,它提供了通过导管腔钩住并收回该装置36的理想的部位。还可以在线材结构36a的交点处形成一个抓取-环(未示出)为收回该装置36提供一个简单的装置。
现在参看图9a和9b,图中示出了根据本发明的又一个实施方案的可穿越的栓塞装置38。装置38包括一个可形成锥形阻塞体38a的弹性弹簧环36a。阻塞体的尖角端停留在血管中与用字母A表示的血流路径相连系。为使这种封闭得以维持,提供了许多向内偏移的部件38c,该部件迫使装置38采取如图9a所示的第一闭合位置。实际上,如可看出的,血液沿方向A流向锥形形状的38a事实上增强了和便于装置38保持固定在血管内的能力。
无论如何,可穿越的栓塞装置38能够采取第二张开位置,因此由装置的侧边逆着用字母B表示的血流方向进入将导致在装置内形成一个轴向的小孔,从而在需要时可使血流恢复或使血管可以通过。
现在参照图10,图中表示根据本发明的一个实施方案的隔膜-型栓塞装置42。该装置包括一个在弹性环形外弹簧42a上张拉着的膜42b,从而形成带有柔性覆盖层的盘。环形外弹簧42a可优选由形状记忆合金,例如镍钛诺,制成,当热至一定温度时产生膨胀,特别是该温度通常与人体相关(即,约98.6°F)。如熟悉此项技术的人所看出的,用于在环形弹簧42a上延伸的可张拉的膜42b可以刺穿和跨越,即可再穿越的,从而以后在血管-阻塞部位的任一侧可以接通,如果将来有需要可将装置打通。
现在参照图11,图中示出根据本发明的另一个优选实施方案的帽盖-线圈栓塞装置40。基本上,装置包括一个包含在弹性体袋40b中的螺旋形线圈40a。装置40能够被压缩,从而允许装置通过投送导管的腔前进,并随后由腔里被一根推杆在需要阻塞的部位推出来。一旦被推出,线圈40a在血管中对准血流的方向沿径向膨胀,从而使覆盖着线圈相应端部的弹性材料40b阻塞住血流。这种装置40,除可实施所需要的血管-阻塞以外,还具有可以提供一个再穿越的轴向通道的优点,所说的通道在张拉在装置40的相应端部上的弹性体材料上形成,在以后某个时间有需要时可在血管中逆向血管-阻塞部位进行操作,利用一根导管通过阻塞部位将装置打通。
图12a和12b表示一个环栓塞装置44,该装置由不-可膨胀材料的第一硬质帽44a和用更具膨胀性的材料制成的第二可膨胀的阻塞物44b组合而成。装置44在阻塞物44b保持不膨胀的状态下由导管远端推出。装置由导管推出时,应使阻塞物44b轴向地放置在用字母C表示的血流方向内,并随后用生物相容的材料例如盐使其膨胀。借助于血流压向膨胀的阻塞物44b的力量,使阻塞物44b的可膨胀材料沿径向膨胀并向外扩展或卡进血管46的腔内,如图12b所示。在这一方面,阻塞物44b利用其所具有的固定的表面积可围绕血管46的腔提供径向压力从而使装置44相对于血管腔保持在固定的位置上。
现在参照图13a和13b,图中示出了根据本发明的一个优选实施方案的可膨胀的斯滕特固定模/袋栓塞装置48。装置48包括由生物相容的材料如镍钛诺制成的基体48a,和在其相应的端部形成的袋48b。基体48a的构成应使其能够采取第一压缩位置以使装置48能够经过导管前进。在这种压缩状态下,如图13a所示,装置48被放置在需封闭的部位时,应使在装置的端部形成的袋48b在用字母D表示的血流的方向上被推出。血液流过柱状结构48a时趋于减少其长度因而导致其直径相应地增加,从而将结构48a锁定在适当的位置上。在这一方面,带有柱状结构48a的基体沿径向压向周围的血管腔从而保持其固定在血管内。如可以看出的,帽或袋48b连接在定向于向着血流上游的柱的端部,导致帽或袋48b轴向地倒转回到柱状结构内从而阻塞了用字母F表示的血流。当推向装置48的血压增加时,装置48的这种设计有利地防止了由所需要的血管-阻塞部位的移动,实际上增强了装置48牢固地固定在血管内血管-阻塞部位的能力,并进一步为通过轴向地位于基体48a内的袋48b再穿越栓塞装置提供了手段。
现在参照图14,图中示出了根据本发明优选实施方案的一个钩-型栓塞装置50。装置50包括一个海绵体-状的结构50a,该结构由具有自其上径向向外延伸的钩或凸出物50b的缠结在一起的线构成,以便将装置50在血流的下游方向嵌入血管壁。利用钩50b和血管52的腔之间的摩擦啮合使装置50长时间地保持在适当的位置上。装置还可以优选带有放射性的标识或可以是射线不能透过的。
图15描述了根据本发明的带包层的球形线圈栓塞装置54的另一个进一步的优选实施方案。该装置包括一个包含在诸如硅酮或聚氨酯的弹性体包层54a中的热膨胀线圈(未示出)。线圈优选由形状记忆合金诸如镍钛诺制成,当其因体温变热时将会增大。基本上,在约98.6°F时线圈将径向膨胀并将径向压向血管56的腔的周围,从而使装置保持固定在特定的部位。如可看出的,线圈可在压缩状态下通过导管置入从而使装置可以容易地投送到特定的部位。
为进一步增强装置54保持固定在血管腔内特定部位的能力,线圈可以设计成在受热膨胀时线圈54b的许多端部由弹性体包层54a伸出,起到将装置54嵌入血管56腔内的作用,从而增强了装置保持固定的能力。
现在参照图16,图中示出了根据本发明的一个优选实施方案的一个计时沙漏栓塞装置58。装置58包括一个柱状管形结构,其端部的直径大于装置中间的直径。装置的每个相应的端部覆盖以移植物或其它薄膜58c,以便在定位于血管腔内后阻塞血流。管形结构由许多在其中点58b被栓在一起的支杆58a组成,使支杆相应的端部径向地向外展开从而施加径向压力于装置的两个端部,如字母G所示。在另一个实施方案中,与在其中点被栓在一起相反,支杆在相应的中点处是偏移的从而在共同地被夹持在一起时形成如图16所示的柱状管形结构。
由于沿血管的长度在两处施加径向压力,该装置58有利地实现了保持固定的较大的能力从而不会由其需要阻塞的部位移动。关于这一点,当较大的压力作用于装置58的端部时,该装置将会更牢固地嵌入血管腔内。另外,当在另一个实施方案中使用偏移的支杆时,在支杆不需要在其中点处联结时,在血管-阻塞部位又提供了一个可穿越的轴向通道,否则支杆将会阻塞该轴向通道。
另外,该装置58具有便于配置以及收回的优点,因为将支杆58a彼此平行地排成一行,装置58可以很容易地采取压缩的直线形状,从而缩小了装置中支杆的径向-展开端的大小。装置58端部直径的这种缩小可使其能够容易地在导管腔内前进或拉出。
现在参照图17,图中示出了根据一个优选实施方案的可移动的栓塞装置60,装置包括内芯60a和外覆盖层60b,其中内芯60a由在诸如对热和冷起化学反应的控制措施,例如使装置60与加热的或冷却的盐溶液相接触,的控制下膨胀和收缩的材料组成。内芯60a的这种膨胀和收缩还可以进一步地用热形状记忆合金诸如镍钛诺或具有所需膨胀力的塑料进行控制。这种内芯60a可进一步地由包在弹性体袋内的水凝胶构成。如可看到的,一旦将内芯60a置入并起反应而进入膨胀状态,外覆盖层60b膨胀并径向压向血管腔周围从而阻塞血流。如可看到的,因为内芯60a是可收缩的,装置60可有利地提供可收回的血管-阻塞从而将栓塞装置移出,在以后有需要时可便于该装置60的移动,外覆盖层60b可优选由具有光滑表面的弹性体材料制成,这可抵抗向内生长和防止血液在其附近的凝结。如可看到的,这种性质使装置60更容易移动而没有损伤或以其它形式破坏腔体组织的可能性。
与图17中所示的实施方案相似,图18描述了一种可移动的气囊栓塞装置62,装置包括内充热膨胀材料的气囊,在温度高于90°F时,可膨胀材料向外膨胀以使气囊夹持在相应于血管壁的固定位置上。由于装置的外表面类似气囊的性质,从而提供了一种很少会引起外伤的封闭血流的装置。当使用图17所示的装置时,利用冷源诸如冷盐水使可移动的气囊栓塞装置62很便利地被收回。同样,为增强这种可回收性,气囊栓塞装置62应由具有光滑外表面的可张拉的材料制成,以抵抗向内生长和防止血液在其上形成凝块。
现在参照图19和20,特别是图19,图中示出了本发明的两个实施方案,该实施方案能够在不止一个方向上限制血流并进一步可用以使血流沿一给定方向改道。关于图19所示的实施方案,其中示出了一个栓塞探测器/填料器64,它包括具有一个中央腔的双气囊导管,在中央腔上有许多在其上形成,分布在其间和整体地形成的小孔64d。当如所示的被置入时,每个相应的气囊64a,64b充气并在血管腔范围内膨胀从而封闭了其间的血流。位于两个相应的气囊64a,64b之间的腔64c可用以从在其上形成的小孔注入对比性介质以确定自受阻血管66区段伸出的分支血管68。位于气囊之间的腔64c还可方便地用以注入栓塞剂以封闭自血管66栓塞段延伸的任何分支血管68。
这些实施方案除提供了所需要的血管-阻塞以外,还提供了确定分支血管68的优点。由于通过欲封堵的主要血管的高血流速度,这些分支血管可以变得不能被找到(即,难于看到)。如熟悉此项技术的人所了解的,这种高血流速度有可能冲掉或以其它方式阻止足够的对比性介质在这些分支血管处产生可探测的浓度。另外,这些实施方案64在导管保留在血管中适当的位置时还有助于注入栓塞剂,从而在需要封堵这些分支血管时减少了对另外的装置和操作的需要。
图20表示一个可置入血管内的三-阀斯滕特固定模70,除封闭血流外,根据需要装置可方便地用以改变通过血管的血液流动的方向。在这一方面,可以象前述的所有其它实施方案一样地被置入,即,在所需的位置上由导管腔推出,斯滕特固定模70还提供了三个能够阻塞或便于血液流动的阀70a,70b,70c。相应的阀70a,70b,70c使得血流路径可以在特定的压力差异下予以控制。这种实施方案70可以方便地根据一组压力状态按规格定做以形成一种流动通道而在另一种差异条件下形成另一个不同的流动通道。
现在参照图21,图中所示的是利用通过导管远端放置血管-阻塞介质72达到所需要的特定-部位的血管-阻塞的另一种优选的方式。如可看到的,这种阻塞介质72可以是可注入的液体,例如液体聚合物,液体在需封闭的一个或几个部位凝胶化成为固态的间隔-充填物质。另外,这种阻塞介质72可以由微球状体组成,微球状体包括可以在欲封闭的部位粘合或聚集的固态或织成的材料。由于围绕阻塞介质生成血液凝块,这种聚集将导致血管的阻塞。为提供可控制地释放这种阻塞介质的装置,可以提供一种能够在投送导管10的腔12内控制抽吸的真空源以吸回任何多余的阻塞介质。
虽然可以了解这里公开的前述的栓塞装置对在血管内进行血管-阻塞是特别适用和合适的,还应看到这些装置在需要对一个通道进行阻塞的所有情况都是有用的。
现在参照图22-26,图中示出了用于在血管系统中特定的部位阻塞血流的另一种方法和装置。如图22所示,系统74包括抽吸源76和能源78的组合,该组合由一个插座装置连接在并应用于导管或类似装置。抽吸源76可以是一些能够产生和保持抽吸力的装置的任何一种。能源78可以包括射频或微波发生器,激光或光源,或可以作为电流的能源。
现在参照图23,图中示出了根据系统74的一个优选实施方案,用以在所需要的部位阻塞血流的投送导管远端80的一个优选实施方案。如所示,远端80包括一个在其最远端形成的至少带有一个电极84的远侧的尖端82以传递由能源78所接受的能量。远侧尖端82还至少提供了至少一个小孔86,通过小孔可以施加由抽吸源76提供的抽吸力。如可看到的,远端80优选包括在远侧尖端82相对侧边上形成的两个小孔86a,86b,以便在其附近提供均匀的抽吸力。近端80优选带有一个能以围绕投送导管径向膨胀的气囊88。
现在参照图24到26,图中示意地示出了应用系统74进行血管腔内封闭的步骤。如图24所示,导管,特别是其远端80,正通过血管系统前进到需要封堵的部位。如上所述,可以使用熟悉此项技术的人所熟知的传统的装置进入需要封堵的部位,例如使用一些成像的方式,诸如利用特定的设置在导管远端80的成像标识。
一旦进入所需的部位,远端80的远侧尖端82刚好位于需要封堵部位的近端。随后在近端80形成的气囊88膨胀从而暂时地封闭血流,以及将远侧尖端82的位置保持在需要形成腔内封闭的部位。随后,使用抽吸源76将血管90的腔拉向和收缩到装置的远侧尖端82附近,如图25所示。为便于血管腔90围绕远侧尖端82的粘结,该远侧尖端82优选为锥形。如可看到的,无论如何,可以使用机械装置使血管腔围绕装置的远侧尖端收缩,例如使用一个可由导管远端伸出的钩,它可以嵌入血管腔并将血管拉到与导管远端相接触。
如图26所示,在远端80的远侧尖端82周围维持这种收缩状态的同时,激发连接在装置上的能源以将能量传递到位于远侧尖端82上的电极84。如所示,电极84将能量送到汇合收缩的血管壁90的连接处,导致腔90的壁被熔合或以其它方式变性成为血管腔内的永久性的封闭物。应予指出,为增强装置更为彻底地熔合或以其它方式封闭血管腔的能力,还可提供加在血管90的腔的能量吸收物质,以使其变性或以其它方式熔合在血管腔上。这些能量吸收物质可以包括诸如血纤维蛋白,聚合物,或胶原蛋白等物质。另外,可提供加在血管90的腔的导电物质诸如盐水,以便于由电极84传递能量到血管90的腔。
如可看到的,用上述的两步方法形成的腔内封闭物,即,使血管腔内的组织收缩和使其熔合以形成一个封闭的团块,从而在血管腔内形成一个永久性的封闭物,这种封闭物在以后仍可再打开,通过切割或其它方式形成一个穿过变性组织块的孔。实际上,可以设想将某种通道连接器,例如在申请人的共同未决的PCT国际专利申请第__号中所描述的,放入熔合的组织从而提供了一种恢复血管内血流的装置。
现在参照图27至30a,图中示出了在血管内封闭血流的方法和装置的另一个实施方案系列。就以下一组实施方案而言,提供了一种栓塞强化物连同使用一种能量的力量将栓塞强化物熔合在血管腔内欲封闭的特定部位。如以上在图2-21中所述的第一栓塞装置实施方案系列,栓塞强化物通过一个导管放置在血管系统中欲栓塞的部位。一旦定位后,使用烧灼的或变性的能源使血管腔熔合在和设想为粘结在栓塞装置上。
现在参照图27,图中示出了第一个这种实施方案。所示的特定实施方案92包括使用由患者体内获得的自体组织94形成的团块,通过导管将其放置在欲封闭的部位。随后,通过位于放置导管腔内的电极,使用一种变性的或烧灼的能量将组织94嵌入血管96的腔上。可以看出,无论如何,这种自体组织94还可以嵌入在需要栓塞的部位而不必熔合在血管腔上。
这种实施方案92提供了有利的高生物相容性,并且这种材料具有丰富来源可以很容易地由宿主患者处取得。再有,利用自体组织实行的血管-阻塞具有易于移动的优点,因为这种组织在以后可以很容易地通过将组织分解而除去,例如利用烧灼或切割该组织。
在另一个实施方案中,如图28所示,栓塞强化物装置包括一块相互缠绕的线网100,在这里称之为栓塞绞合线,绞合线与其结构内的不同的随机点相联系并连接到一个或几个电极102上,因此这些绞合线100可以充分供能引起凝结并因而在血管腔内形成栓塞。现在可以认为对绞合线100使用2到50瓦足以在欲栓塞的部位引起凝结。如熟悉此项技术的人所能了解的,这种能量的使用必须应用一个外部的接地板106以形成用以发出这种能量的完整的电路。
现在参照图29a和29b,图中示出了根据本发明的栓塞系统的另一个实施方案。首先参照图29a,在这里提供了一个柱状管形电极栓110,电极栓具有一个自其近端延伸的绝缘的导线/导电体112。导线/导电体112优选包括一个在其远端,刚好在电极栓110的近端,形成的分割点112a。如图29b所示,导线/导电体112通过一个连接器118连接在能源116上,能源优选包括一个射频发生器。
一旦到达欲封闭的部位,即通过电极栓110施加射频能量,使血管114因腔体组织114脱水和变性而围绕栓110收缩,如图29b所示。于是栓110熔合在血管的腔114上,从而封闭了血流。在栓110被充分地熔合在腔体组织114以后,将导线/导电体112在其远端形成的分割点112a处切断,使导线/导电体112与栓110脱开。如可看到的,为使导线112在分割点112a处切断,可将其做成使导线112在足够的拉力作用下在分割点112a处断裂。在这一方面,应该看到使导线112在分割点112a断裂所需的拉力应小于使栓110由其在血管腔内所熔合的组织上移动所需的拉力。作为另一种选择,分割点112a的形成可以象熔断器一样,当流过其间的能量过载时断裂。
现在参照图30,图中示出了根据本发明的形成栓塞的方法的又一个优选实施方案。在该实施方案120中,一个具有在其远端的近端侧形成的可膨胀的气囊128的配置导管10已前进到欲封闭的血管系统中的部位。气囊128充气到足以封闭血流的程度,并且将导管的远端14固定在适当的位置上以便在血管中所需的部位形成腔内的阻塞。在这一方面,一旦维持在所需的部位以后,通过气囊128,一种导电的物质122,例如盐水,由导管14腔的远端注入。随后一股由导管14远端延伸的绝缘的电极126发出的电流流过导电物质。于是电流流过导电物质122和血管130的腔的周围,使腔130变性从而形成一个封闭物130a,如图30a所示。如可看到的,在实施这种操作之前放置气囊128是必须的,因为在有血流或其它含-蛋白质液体存在的情况下应用电流会导致后者变性和凝结,从而可能在患者体内导致不需要的血栓形成。
已经描述了许多可供选择的在血管系统内特定的部位或一些部位封堵血流的方法和装置。尽管可以理解这里所公开的方法和装置非常适合于在血管腔内的封堵,普通熟悉此项技术的人应该了解在这里所描述的一般的方法和装置同样适用于目的在于在组织表面之间形成粘结而需要将组织并置在一起的所有情况。本发明的这些应用并非限制地可以包括封闭伤口,肠,淋巴管,管,组织之间的缝隙,或穿刺进入的部位。还应该了解,这里公开的方法和装置可用于在体内特定的部位促进药物的投送。因此可以了解,在不偏离本发明的范围的情况下可以做出许多修改。

Claims (88)

1.一种可置入血管用以在至少一个方向上阻止通过该血管的血流的装置,所说的装置包括:
a)一个血管啮合部分,该部分初始时配置成径向收缩的形状
  以便所说的装置可以进入所说的血管锥形段的腔内,并随后
  膨胀成为工作形状,与周围的血管壁摩擦啮合从而将装置保
  持在血管腔内的固定的位置上;和
b)一个连接在所说的啮合部分上的腔阻塞部分,所说的腔阻
  塞部分的形状应在所说的啮合部分处于工作形状并与血管
  壁相接触时能使所说的腔阻塞部分在至少一个方向上阻止
  通过所说的腔的血流。
2.根据权利要求1中所说的装置,其特征在于所说的血管啮合部分为一个线材构架。
3.根据权利要求1中所说的装置,其特征在于所说的血管啮合部分是一个可膨胀的部件。
4.根据权利要求1中所说的装置,其特征在于所说的血管啮合部分具有可嵌入血管壁内的凸出物。
5.根据权利要求1中所说的装置,其特征在于所说的血管啮合部分具有可嵌入血管的钩。
6.根据权利要求1中所说的装置,其特征在于所说的血管啮合部分带有一种可粘附于血管壁上的黏合剂。
7.根据权利要求1中所说的装置,其特征在于所说的血管啮合部分包括许多在中央部位被连接在一起的部件,并由所说的中央部位向外发散,当所说的血管啮合部分处于工作形状时,所说的细长的部件将对血管壁施加径向向外的压力,所说的中央部位继续保持其位置和形状,从而当装置置入血管里的时候,作用在所说的中央部位的血液动力压力将使所说的细长的部件对血管壁施加更大的压力。
8.根据权利要求1中所说的装置,其特征在于所说的腔阻塞部分包括一个膜。
9.根据权利要求8中所说的装置,其特征在于所说的膜是一个弹性体膜。
10.根据权利要求8中所说的装置,其特征在于所说的膜的一侧由能够抵抗细胞向内生长的第一种材料制成,所说的膜的另一侧由容许细胞向内生长的第二种材料制成。
11.根据权利要求1中所说的装置,其特征在于所说的腔阻塞部分是一个海绵体。
12.根据权利要求11中所说的装置,其特征在于形成所说的海绵体的材料选自:
凝胶泡沫;
胶原蛋白;
聚合物泡沫材料;
织物材料;和
纺织品。
13.根据权利要求1中所说的装置,其特征在于所说的腔阻塞部分是一个圆盘。
14.根据权利要求1中所说的装置,其特征在于所说的腔阻塞部分是一个纺织品部件。
15.根据权利要求1中所说的装置,其特征在于所说的腔阻塞部分至少部分地由一种材料形成,该材料在装置已被置入血管腔内以后,能够被一种贯穿腔体前进的刺穿部件所穿透。
16.根据权利要求1中所说的装置,其特征在于装置的血管啮合部分在置入后可以沿径向收缩而由血管壁上脱开,从而便于移走装置。
17.根据权利要求16中所说的装置,其特征在于所说的装置还包括一个在装置上形成的连接器,以便于将装置连接到一个贯穿腔体插入的回收工具上,该工具可进行操作将装置拉入一个相邻的导管。
18.根据权利要求17中所说的装置,其特征在于装置的血管啮合部分的构成,能在回收工具已经连接在连接器上并在回收工具受到拉力作用时,装置的血管啮合部分沿径向收缩并与血管壁脱开,从而便于将装置收回到邻近的导管中。
19.根据权利要求1中所说的装置,其特征在于所说的血管啮合部分是由一种形状记忆材料制成的,该部分在加热到体温时即转换为所说的工作形状,但将装置浸泡在冷却的液体中从而使装置冷却到低于体温的形状记忆转换温度时,将原位产生径向收缩。
20.根据权利要求1中所说的装置,其特征在于所说的血管啮合部分是由可偏移到所说的工作形状的弹性自-膨胀材料制成的,在不受约束时,所说的装置将弹性地自-膨胀为所说的工作形状。
21.根据权利要求1中所说的装置,其特征在于所说的血管啮合部分是由塑性可变形材料制成的,该部分初始时具有所说的径向紧凑的形状,但随后因压力作用在所说的装置上而变形成为所说的工作形状。
22.根据权利要求1中所说的装置,其特征在于:
a)所说的血管啮合部分包括一个构架,该构架当处于其径向
  紧凑的形状时,通常为柱状,所说的构架具有第一和第二
  相对的端部,当构架膨胀为其工作形状并与所说的血管壁
  啮合时,所说的构架能够采取适应锥形血管壁形状的通常
  为截-锥形的形状;和
b)所说的腔阻塞部分包括一个安装在所说的构架上的柔软
  的密封层,当所说的构架膨胀为其工作形状并与所说的血
  管壁啮合时,所说的密封层的形状和位置应能在所说的血
  管腔内形成一个横向的挡层。
23.根据权利要求22中所说的装置,其特征在于所说的柱状构架是由一种形状记忆材料制成的,构架在室温时具有所说的压缩形状,当加热到体温时转换为所说的工作形状。
24.根据权利要求22中所说的装置,其特征在于所说的柱状构架具有许多在其上形成的可嵌入血管壁的凸出物。
25.根据权利要求24中所说的装置,其特征在于所说的构架是由线材部件构成的且其中所说的凸出物包括在所说的线材部件上形成的弯曲段。
26.根据权利要求22中所说的装置,其特征在于所说的柔软的密封层在所说的柱状构架的第一端部上形成,并放置在相对于通过血管腔的血流的方向,使正常的血压在所说的密封层上的作用推动所说的柱状构架的第二端部进一步膨胀,从而增加所说的构架的第二端部作用在血管壁上的压力。
27.根据权利要求26中所说的装置,其特征在于所说的柱状构架的第二端部向外扩张,当处于其工作形状时,所说的第二端部将适合于并啮合在血管的一个锥形区段的腔内。
28.根据权利要求22中所说的装置,其特征在于所说的密封层是一个具有多孔织物的弹性体膜。
29.根据权利要求22中所说的装置,其特征在于所说的柱状结构带有一种X射线照相可见的材料。
30.根据权利要求22中所说的装置,其特征在于:
a)所说的柱状构架包括许多沿纵向延伸并在其相应的端部
  共同连接在一起的线材;和
b)所说的密封层是环绕所说的柱状结构的所说的第一端部
  形成的,从而使纵向延伸的线材由其一侧延伸。
31.根据权利要求30中所说的装置,其特征在于所说的密封层在构架上的取向相对于血流的方向,使作用在所说的密封层上的血液动力压力可推动所说的沿纵向延伸的线材嵌入所说的血管的所说的腔内。
32.根据权利要求22中所说的装置,其特征在于:
a)所说的柱状构架包括细长的通常成正弦曲线形状的部
  件;和
b)所说的弹性体密封层完全覆盖了所说的构架。
33.根据权利要求32中所说的装置,其特征在于所说的细长的部件采取弯弯-曲曲的形状,所说的弯弯-曲曲的尖端位于所说的柱状构架的第一和第二端部。
34.根据权利要求21中所说的装置,其特征在于血管啮合部分是一个带有纵轴的构架,所说的构架由许多细长的线材部件形成,每一个这样的线材部件具有第一和第二端部,所说的线材部件围绕并平行于所说的纵轴进行布置,所说的部件的第一和第二端部是共终端的和连接在一起的从而形成所说的构架的端部,并且所说的线材部件由所说的纵轴径向向外弯曲,使所说的构架具有通常为球茎的形状。
35.根据权利要求34中所说的装置,其特征在于所说的构架的端部是沿轴向返转回到所说的构架。
36.根据权利要求34中所说的装置,其特征在于构架的中间部分是径向收缩的,使所说的构架在第一和第二球茎部分之间具有一个径向凹进的中间-部分。
37.根据权利要求1中所说的装置,其特征在于:
a)所说的血管啮合部分包括一个锥形构架;和
b)所说的腔阻塞部分包括一个在所说的构架上形成的柔软
  的覆盖层。
38.根据权利要求37中所说的装置,其特征在于所说的锥形构架包括许多细长的具有第一端部和第二端部的线材部件,所说的线材部件的第一端部是聚合的和共同连接在一起的形成构架的一端,所说的线材部件的第二端部是不连接的和向外偏移的,从而当所说的构架膨胀到其工作形状时,所说的线材部件的第二端部将沿径向向外伸出并与血管壁啮合。
39.根据权利要求38中所说的装置,其特征在于所说的构架具有一个在其上形成的抓取环以使所说的装置能够可选择地由该装置所在的位置移走。
40.根据权利要求1中所说的装置,其特征在于:
a)血管啮合部分包括至少两个自-膨胀的线材结构,该结构
  具有基本上在其相应的中点形成的弯曲段,所说的至少两
  个自-膨胀线材结构的形成应与在其中点形成的弯曲段
  相交,所说的线材结构的设计和形状应能采取第一压缩形
  状以便于置入导管,和第二膨胀形状用以径向压向并粘附
  于所说的血管的所说的腔;和
b)所说的腔阻塞装置包括一个围绕所说的相交的线材结构
  形成的微孔膜,所说的膜围绕所说的相交的线材形成,使
在所说的相交的线材采取所说的第二膨胀形状时形成杯
-状的结构。
41.根据权利要求40中所说的装置,其特征在于所说的微孔膜的设计和形状应在所说的装置置入所说的血管的所说的腔时便于血凝块的形成。
42.根据权利要求40中所说的装置,其特征在于所说的装置还包括一个在所说的线材结构的所说的相交处形成的抓取环,所说的抓取环的设计和形状应允许所说的装置由所说的血管的所说的腔内安放的位置上移走。
43.根据权利要求1中所说的装置,其特征在于所说的装置包括一个环状弹簧盘,该盘具有许多由其上延伸的细长的向内-偏移的部件,所说的向内-偏移的细长部件具有在其上形成的柔软的织物以形成一个锥-状结构,所说装置的设计和形状决定其取向使所说的锥形结构位于欲封堵血流的方向上。
44.根据权利要求43中所说的装置,其特征在于所说的环状弹簧应设计成径向压向血管壁并牢固地将所说的装置放置在所说的血管的所说的腔内。
45.根据权利要求44中所说的装置,其特征在于所说的锥-状结构具有在其最-远的尖端形成的一个小孔,所说的小孔的设计和形状应能采取第一关闭位置和第二开放位置,在一个力通过所说的装置由被封堵的血流相反的一侧沿轴向作用时采取所说的第二开放位置。
46.根据权利要求1中所说的装置,其特征在于所说的装置包括一个环形弹簧,弹簧具有在其上形成的柔软的膜,所说的环形弹簧向外偏移使得在所说的装置置入血管腔内时,所说的环形弹簧围绕所说的血管的所说的腔施加径向的压力。
47.根据权利要求46中所说的装置,其特征在于所说的环形外弹簧是由热膨胀材料构成的,在加热至体温时使所说的弹簧沿径向膨胀从而在所说的装置被置入血管腔内时,所说的环形弹簧径向膨胀并压向所说的血管的所说的腔。
48.根据权利要求46中所说的装置,其特征在于所说的膜可以有选择地被刺穿。
49.根据权利要求1中所说的装置,其特征在于所说的装置包括:
a)一个螺旋形线圈,其尺寸适合于轴向地放置在所说的血管
  的所说的腔内,所说的螺旋形线圈应设计成能够采取第一
  压缩形状以置入所说的导管的所说的腔,和第二膨胀形
  状,当所说的装置可选择地放置在血管中时,径向压向所
  说的血管的所说的腔;和
b)一个覆盖所说的螺旋形线圈的弹性体袋,所说的弹性体袋
  应设计和配置成张拉在所说的螺旋形线圈的相对端以形
  成一个血管-阻塞的挡层。
50.根据权利要求49中所说的装置,其特征在于所说的弹性体袋可以有选择性地刺穿,在所说的装置的所说的螺旋形线圈被轴向地置入所说的腔内的情况下,在所说的血流已被阻塞的特定部位确定一个再穿越的轴向通道。
51.根据权利要求1中所说的装置,其特征在于所说的装置包括一个由不可-膨胀材料制成的硬质盖帽以及一个可膨胀的阻塞器,所说的盖帽和阻塞器的尺寸在所说的阻塞器保持不膨胀的状态时适合于置入所说的导管的所说的腔,所说的阻塞器的膨胀应该是在所说的装置已置入于所说的特定部位时,所说的阻塞器径向膨胀并压向所说的血管的所说的腔,使所说的装置牢固地放置在该处。
52.根据权利要求3中所说的装置,其特征在于辅助阻塞器有一个固定的表面积,并且其设计使其取向为欲阻塞的血流的方向,从而在阻塞器已被置入并受到血流的压力作用时,所说的阻塞器可进一步地在所说的特定部位向所说的腔的周围施加径向-挤压力。
53.根据权利要求1中所说的装置,其特征在于:
a)所说的血管啮合部分包括一个柱状的线材基体,该基体设
  计成可采取第一径向压缩形状和第二径向膨胀形状,当保
  持为所说的第一压缩形状时,所说的基体可以通过所说的
  导管的所说的腔被置入,当保持为所说的第二膨胀形状时
  所说的基体可牢固地定位于所说的血管的所说的腔内;和
b)所说的腔阻塞部分包括一个用于阻塞血流的沿轴向围绕
  所说的基体的相应的端部形成的袋,所说的袋与所说的基
  体的连接应能在所说的装置被置入血管的腔内时使所说
  的袋的取向为血流的方向,所说的袋返回进入所说的基
  体,使所说的基体采取所说的第二膨胀形状。
54.根据权利要求53中所说的装置,其特征在于所说的袋可以有选择性地被刺穿,从而使装置在所说的血流已被阻塞的特定部位形成一个可再穿越的轴向通道。
55.根据权利要求1中所说的装置,其特征在于所说的装置包括一个由网状线材构成的中央团块,团块上具有许多由其上径向-伸出的凸出物,所说的凸出物的设计和取向可径向嵌入所说的血管的所说的腔内,从而使所说的装置保持牢固地固定在所说的血流被封堵的所说的特定部位。
56.根据权利要求55中所说的装置,其特征在于所说的线网的设计和结构应能促使凝块围绕所说的装置形成,从而围绕所说的装置形成一个血管-阻塞团块。
57.根据权利要求55中所说的装置,其特征在于所说的凸出物包括一些适合于嵌入所说的血管的所说的腔内的钩。
58.根据权利要求55中所说的装置,其特征在于所说的装置是由形状记忆材料制成的,使所说的装置可以采取第一压缩形状,在承受第一降低温度时可用以通过导管进行置入,和采取第二膨胀形状,在承受第二升高的温度时用以沿径向压向并粘结在所说的血管的所说的腔上。
59.根据权利要求1中所说的装置,其特征在于所说的装置包括一个装在弹性体包层里的球状线圈,所说的球状线圈应设计成可采取第一压缩形状和第二膨胀形状,从而在所说的装置保持为所说的压缩状态时,所说的装置可通过所说的导管的所说的腔进行配置,而在保持为所说的膨胀形状时,可以径向膨胀并压在所说的导管的所说的腔上,使所说的装置保持牢固地固定在所说的血流被封堵的所说的特定部位。
60.根据权利要求59中所说的装置,其特征在于所说的球状线圈是由热-膨胀材料制成的,所说的球形线圈在暴露于第一降低温度时采取所说的第一压缩形状,而在暴露于第二升高温度时采取所说的第二膨胀形状。
61.根据权利要求59中所说的装置,其特征在于所说的球形线圈具有许多由所说的弹性体包层沿径向伸出的细长的凸出物,所说的凸出物的设计和构成应能嵌入所说的血管的所说的腔内从而牢固地将该装置固定在所说的血流被封堵的特定部位。
62.根据权利要求1中所说的装置,其特征在于所说的血管啮合部分包括一个柱状管形结构,该结构具有一个中间部分和相对的第一和第二端部,所说的相对的第一和第二端部具有的直径大于所说的中间部分的直径,所说的腔阻塞部分包括在所说的中间部分的第一和第二端部上形成的第一和第二弹性体密封层,当所说的装置轴向地放置在所说的血管的腔内时,所说的弹性体密封层生成血管-阻塞挡层,所说的相对的第一和第二端部的设计和构成应能径向压向所说的血管的所说的腔,以使所说的装置保持牢固地固定在所说的血流被封堵的所说的特定部位上。
63.根据权利要求61中所说的装置,其特征在于所说的柱状管形结构是由许多在其相应的中点拴在一起的支杆组成的,所说的支杆在其中点处的联结使所说的支杆的相应的端部偏移成为径向地向外展开,从而压向所说的血管的所说的腔。
64.根据权利要求63中所说的装置,其特征在于所说的支杆在其相应的中点的联结使所说的柱状结构可以采取第一压缩形状,使相对的第一和第二端部的直径缩小,从而使所说的装置可以通过一个导管的腔进行设置和收回。
65.根据权利要求64中所说的装置,其特征在于所说的柱状管形结构所采取的所说的第一压缩位置是通过将所说的支杆排列成彼此基本平行的位置而达到的。
66.根据权利要求1中所说的装置,其特征在于所说的装置包括一个包含在外覆盖层里的内芯,所说的内芯的设计应能有选择性地采取第一压缩形状和第二膨胀形状,其中所说的装置保持为所说的第一压缩形状时所说的装置可以通过一个导管的腔置入,而当所说的装置采取所说的第二膨胀形状时,所说的装置膨胀产生径向挤压并牢固地固定在所说的特定部位。
67.根据权利要求66中所说的装置,其特征在于所说的外覆盖层是由一种具有光滑外表面的材料制成的,可以抵抗向内生长和防止血液在其上形成凝块。
68.根据权利要求1中所说的装置,其特征在于所说的装置包括一个用热膨胀材料充填的气囊,使所说的气囊可有选择性地采取第一收缩的形状和第二膨胀形状,在所说的热膨胀材料采取所说的第一收缩形状时,气囊可通过所说的导管的所说的腔置入,在保持所说的第二膨胀形状时,气囊在所说的血管的所说的腔内径向膨胀形成一个血管-阻塞体并保持牢固地固定在所说的特定部位。
69.根据权利要求68中所陈述的装置,其特征在于所说的装置在承受第一降低温度时采取所说的第一收缩的位置,在承受第二升高的温度时所说的气囊采取所说的第二膨胀形状。
70.根据权利要求69中所陈述的装置,其特征在于所说的装置当加热至体温时采取所说的第二膨胀形状。
71.根据权利要求68中所陈述的装置,其特征在于所说的气囊是由一种具有光滑外表面的柔软的材料制成的,可以抵抗向内生长和防止血液在其周围形成凝块。
72.根据权利要求1中所陈述的装置,其特征在于所说的装置包括:
a)第一和第二气囊导管可以有选择性地沿血管腔的一个区
  段定位,所说的第一和第二气囊可以膨胀使通过所说的区
  段的血流被阻塞;和
b)一个设置在所说的第一和第二气囊导管之间的中间腔,所
  说的中间腔具有许多在其上形成的小孔,通过小孔可注入
  栓塞剂,所说的栓塞剂围绕所说的血管的所说的腔形成一
  个血管-阻塞屏障。
73.根据权利要求72中所说的装置,其特征在于所说的第一和第二气囊可沿血管腔的一个区段定位,该区段具有至少一个由其上延伸的侧分支血管,设置在所说的第一和第二气囊导管之间的所说的腔的设计和构成应能注入栓塞剂以阻塞通过所说的至少一个分支血管的血流。
74.根据权利要求72中所陈述的装置,其特征在于可以在通过设置在所说的第一和第二导管气囊中间的腔上的小孔注入所说的栓塞剂之前注入对比性介质,从而确定所说的分支血管。
75.根据权利要求1中所说的装置,其特征在于所说的装置包括一个可以有选择性地定位在血管腔的一个区段内的三-阀斯滕特固定模,该区段具有至少一个由其上延伸的分支血管,所说的斯滕特固定模的定位应使通过所说的血管和所说的至少一个在其上延伸的分支血管的血流有选择性地受到控制,所说的斯滕特固定模的设计和构成应能采取一种压缩的形状使所说的斯滕特固定模可以通过一个导管的腔进行置入,所说的斯滕特固定模的设计和构成应能采取第二膨胀形状,当定位于腔的所说的区段时,所说的斯滕特固定模围绕所说的腔施加一个轴向力使所说的斯滕特固定模保持牢固地固定在所说的特定部位。
76.根据权利要求1中所说的装置,其特征在于所说的装置包括一种化学介质,当由所说的导管被置入以后,粘附在所说的血管的所说的腔上并凝结成血管-阻塞团块。
77.根据权利要求76中所说的装置,其特征在于该装置包括一种含有一种凝块诱发物质的介质,该介质粘附在血管腔上并在其上形成血液凝块,所说的血液凝块与所说的介质熔合从而形成一个血管-阻塞团块。
78.一种用以封闭血管腔的装置,所说的装置包括:
一个具有一个远端的细长的探头部件;
用于在探头的远端附近的部位使血管壁收缩的装置;
一个血管壁熔合装置用以熔合血管壁;
所说的探头可以置入血管中需要封闭血管腔的一个部位,随后使用所说的用于使血管壁收缩的装置以使血管在探头远端附近的部分收缩,然后用所说的血管壁熔合装置在收缩区域将血管壁熔合从而将血管腔封闭。
79.根据权利要求78中所说的装置,其特征在于所说的用于使血管壁收缩的装置是一个吸力腔,该吸力腔通过探头沿纵向延伸并终止于至少一个吸力部分,使吸力可以作用在探头远端附近的血管壁上,导致血管在该部位的收缩。
80.根据权利要求78中所说的装置,其特征在于所说的用于使血管壁收缩的装置是一种与血管壁可以相连接的装置并可用以迫使血管壁成为收缩的形状。
81.根据权利要求78中所说的装置,其特征在于所说的血管熔合装置是一个粘合剂可以从中通过的腔,所说的腔终止于一个粘合剂出口部分,使粘合剂可以通过探头注入,从而在血管壁已收缩的区域将血管腔封闭。
82.根据权利要求78中所说的装置,其特征在于所说的血管壁熔合装置是一个形成于探头上的能量发射部件并可操作使其发射能量从而在血管壁已收缩的区域将血管腔封闭。
83.根据权利要求82中所说的装置,其特征在于所说的能量发射部件是一个电极。
84.根据权利要求83中所说的装置,其特征在于所说的电极是单极的电极。
85.根据权利要求83中所说的装置,其特征在于所说的电极是双极的电极。
86.根据权利要求79中所说的装置,其特征在于所说的装置还包括:
一个在所说的至少一个吸力部分和所说的至少一个能量发射部件的近端处连接在所说的探头上的可膨胀的气囊,所说的气囊的构成应能在使所说的气囊膨胀时可基本上将血管的腔封闭并阻止从其中通过的血流。
87.一种用以封闭血管的腔的装置,所说的装置包括:
一个细长的可贯穿腔体地插入的探头,具有一个连接在其远端上的可分离的芯部件和一个沿纵向延伸贯穿探头的能量-传输通道,所说的探头可插入血管的腔内,使芯部件位于需要封闭血管腔的部位,随后能量通过探头部件使血管壁收缩于芯部件附近并与之啮合,从而将血管腔封闭,其后所说的芯部件与所说的探头部件分离,将探头部件由体内抽出和移走,留下芯部件置于血管的收缩区域内。
88.一种用以封闭血管的腔的装置,所说的装置包括:
一个细长的导管,导管具有沿纵向于其中延伸的空心腔和终止于一个远端的开口;
一个能量-发送部件,该部件可以前进到导管的远端出口之外;
所说的导管可以通过血管前进到使导管的远端靠近欲封闭的血管部位,通过导管腔注入一些非-蛋白质的,传导-能量的液体以充填导管远端附近的血管腔,所说的能量传导部件前进到导管的开口以外进入传导-能量的液体之中,使由能量发送部件发出的能量通过传导能量的液体传送到周围的血管壁,从而使血管收缩并在该位置上被封闭。
CN97193313A 1996-02-02 1997-01-31 用于阻塞通过血管的流动的方法与装置 Pending CN1216929A (zh)

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US08/730,327 US6190353B1 (en) 1995-10-13 1996-10-11 Methods and apparatus for bypassing arterial obstructions and/or performing other transvascular procedures
US08/730,327 1996-10-11
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CN116269600A (zh) * 2023-04-24 2023-06-23 上海心瑞医疗科技有限公司 一种主动脉阻血装置

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