CN101426454A - 柔软的血管栓塞装置 - Google Patents

柔软的血管栓塞装置 Download PDF

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CN101426454A
CN101426454A CNA2005800166627A CN200580016662A CN101426454A CN 101426454 A CN101426454 A CN 101426454A CN A2005800166627 A CNA2005800166627 A CN A2005800166627A CN 200580016662 A CN200580016662 A CN 200580016662A CN 101426454 A CN101426454 A CN 101426454A
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李·阿龙·别列兹
阔斯·广·德兰
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Abstract

本发明提供了一种在血管内修正血流但维持血液流向周围组织的血管栓塞装置。该栓塞装置包括一种柔软的，易压缩和弯曲的栓塞装置，特别适合治疗大脑内的动脉瘤。该神经血管栓塞装置可以用微导管展开。栓塞装置可以以螺旋方式编织金属丝而形成，沿栓塞装置的长度具有多样化的格子密度。栓塞装置也可以在相同轴面上具有不同的格子密度。

Description

柔软的血管栓塞装置
相关申请
本申请受益于2004年5月25日申请的美国临时申请，序列号：60/574,429，发明名称：柔软的血管修复装置(Flexible Vascular Prosthesis)，特此申明。将这个申请在这里作为参考文件特别并入。
技术领域
本发明主要涉及一种能够被用于血管系统以治疗普通血管畸形的可移植装置，更特别地，涉及一种柔软的、不会引起排斥的装置，其能被引入病人的血管系统以栓塞和锢囚动脉瘤(aneurysms)，尤其是脑动脉瘤。
背景技术
血管系统的管壁，特别是动脉血管壁，可能会形成名为动脉瘤的病态扩张。通常观察到的动脉瘤为动脉血管壁形成的气囊外突(ballooning-out)。这是由疾病，损伤或先天性异常而削弱了血管壁的结果。动脉瘤拥有薄的、不牢靠的管壁，并且有一种破裂的趋势，通常由高血压引起或被恶化。动脉瘤可以被发现于身体的不同部分；最普通的是腹部大动脉动脉瘤(abdominal aortic aneurysms，AAA)和脑动脉瘤。动脉瘤的单独存在并不总是危及生命的，但是它们能有严重的健康后果，比如如果有个动脉瘤在脑中破裂会导致中风。另外，众所周知，一个破裂的动脉瘤也会导致死亡。
最普通的脑动脉瘤类型是一种称为囊状动脉瘤，通常被发现在血管的分叉处。分叉处，即“Y”的“V”的底部，能被血液流动产生的血液动力学力所削弱。在组织学水平，动脉血管壁细胞受到损害形成动脉瘤。损害被认为是由于血液流动产生的剪切力所致。剪切力产生热，从而毁掉细胞。这些作用于血管壁的血液动力学力，可能与血管壁内在的异常性协力，被认为是大脑动脉的这些囊状动脉瘤的起因、生长和破裂的根本原因(Lieberand Gounis，The Physics of Endoluminal stenting in the Treatment of CerebrovascularAneurysms，Neurol Res 2002：24：S32-S42)。在组织学研究中，与圆形的健康细胞相比，受损害的内膜细胞被拉长。作为动脉几何形状及血液的粘度、密度和速度的一种作用，剪切力在心动周期的不同阶段、动脉血管壁上的位置和在不同个体中能够变化很大。一旦动脉瘤形成，在动脉瘤中血液流动的波动尤其重要，因为它们能引起动脉瘤壁的振动，而这种振动有助于动脉瘤进一步发展及至最后的破裂。关于上述概念的更为详细的描述见，比如，Steiger，Pathophysiology of Development and Rupture of Cerebral Aneurysms，ActaNeurochir Suppl 1990：48：1-57；Fergueson，Physical Factors in the Initiation，Growth andRupture of Human Intracranial Saccular Aneurysms，J Neurosurg 1972：37：666-677。
通常在动脉循环中通过去除血管被削弱部分来治疗动脉瘤。对于治疗脑动脉瘤，用多种方式进行这样的增强：(i)外科手术夹闭，即在动脉瘤的基部用一把金属剪刀进行夹闭；(ii)用微线圈，即细软线圈(small，flexible wire coils)，结扎动脉瘤；(iii)用栓塞材料填充动脉瘤；(iv)用可分离的气球囊(detachable balloons)或弹簧圈(coils)阻塞提供养分给动脉瘤的母体血管；和(v)血管内支架。这些不同方法的综合讨论与回顾见Qureshi，Endovascular Treatment of Cerebrovascular Diseases and Intracranial Neoplasms，Lancet.2004 Mar 6；363(9411)：804-13；Brilstra et al.Treatment of Intracranial Aneurysms byEmbolization with Coils：A Systematic Review，Stroke 1999；30：470-476。
随着微创介入技术(minimally invasive interventional techniques)日益显著，用于治疗神经血管动脉瘤的以微导管为基础的方法变得更加流行。微导管，无论是流体的还是金属的，用来传送栓塞材料、微线圈或者其他结构(例如：支架)以栓塞动脉瘤。微线圈能够通过微导管，在动脉瘤里利用机械或者化学分离机理展开，或在母体血管中展开以永久栓塞它，这样阻止血液流进动脉瘤。或者，支架可以通过神经血管系统到达所期望的部位。Pereira的文章(History of Endovascular Aneurysms Occlusion in Management ofCerebral Aneurysms；Eds：Le Roux et al.，2004，pp：11-26)提供了极好的关于动脉瘤检测和治疗可选择方法的历史的背景资料。
注意到在许多上面提到的文章中，以及在脑动脉瘤的起因、形成和破裂基础上，非常明显，动脉瘤治疗目标是减少动脉瘤破裂的危险和由此带来的蛛网膜下出血后果。还应该注意到，当非常希望防止血液流进动脉瘤时，以便削弱的动脉瘤壁不会破裂，流向周围组织的血液没有被用来阻止血液流向动脉瘤的方法所限制可能也是生死攸关的。为了治疗体内其它血管异常而发展的传统支架不适用于栓塞脑动脉瘤。因为当高氧消耗体，比如脑组织，被剥夺所需血流时，可能导致所有常见并发症。
已有的治疗神经血管动脉瘤的方法存在很多缺点。神经血管系统的血管是身体中最曲折的，确实比冠状循环的血管还要曲折。因此，使用有时在神经血管系统中用于治疗动脉瘤的僵硬的冠状支架通过神经血管系统，这对于外科医生是一种挑战。修复装置的弯曲力预示修复装置通过血管系统的可操作性；与具有高弯曲力的修复装置相比，具有低弯曲力意味着该修复装置更容易通过血管系统。典型冠状支架的弯曲力(弯曲0.5英寸悬臂成90度的力)是0.05磅每英寸(1b-in)。因此，拥有比已有支架更柔软的神经系统修复装置将是很有用的。
已存在的支架结构，无论是用在冠状血管或者是在神经血管系统(微线圈)通常是直的，经常是从直的含有僵硬的金属材料的导管或电线的编织套激光切割获得。可是，绝大多数的血管是弯曲的。因此，当目前的支架结构和微线圈试图使弯曲的血管壁变直时，它们给予血管壁非常大的压力。对于削弱的血管壁，尤其是有动脉瘤形成倾向的血管壁，将可能有灾难性的后果。
早就注意到，作用在血管，尤其是在分叉点的血液动力学力导致血管壁的削弱。这些力的最重要的来源是血流方向的突然改变。因此，如果能够最小化分叉点的血流方向的突然改变，那将是很有益处的。
已存在的栓塞动脉瘤的方法可能导致另外一系列问题。仅仅通过栓塞材料(弹簧圈或流体聚合物)填塞或充满动脉瘤的方法不能解决促进动脉瘤形成的基本的流动异常性。
目前，存在许多不同的支架结构和支架的展开方法。在被放置在一个气囊导管上后，置于内腔的支架结构能被展开。或者，自我展开部件以压缩状态插入，需要展开时展开。所有的支架需要有径向的刚性去保持内腔的开放性，同时拥有纵向的柔软性使通过血管系统的弯曲通道变得容易。对于气囊展开支架，支架安放在导管远端的气囊上，导管前进到达期望的位置，气囊膨胀以展开支架成永久的展开状态。然后气囊放气，撤回导管，留下展开的支架以维持血管不闭合。因为分割或破裂大脑内的血管的潜在的致死后果，气囊展开支架的使用是充满问题的。气囊展开支架的合适展开要求气囊展开支架的轻微展开以包埋支架于血管壁且误差幅度要小。气囊展开支架也不适合用于由近到远逐渐变细的大脑血管的自然尖端。如果支架是从母体血管进入更小的支路血管，血管间直径的变化使得安全地展开气囊展开支架变得困难。自我展开支架，压缩或折叠支架由包裹在压缩支架的外部限制外壳维持以保持压缩状态直到展开。展开时，撤回外部限制外壳以打开压缩的支架，支架展开，保持血管开着。另外，和用于传送大的冠状支架至冠状(动脉)相比，用来传送这些修复装置的导管是外径为0.65mm至1.3mm的微导管。
已提出各种各样的支架结构和解决方法用于治疗大脑动脉瘤。美国专利(专利号：6,669,719，Wallace et al.)描述了一种用于颅骨内的支架和支架导管。一个卷起来的片状支架可释放的安放于导管的远端。一旦卷起来的片状支架被放置在动脉瘤，支架就释放开来。这导致立刻完全隔离动脉瘤，包围循环系统的旁路，使血流从动脉瘤改道。这样一个系统的很大的一个缺点是当支架展开后，在目的动脉瘤的周围旁路被剥夺了所需的血流。
美国专利(专利号：6,605,110，Harrison)描述了一种自我展开支架，用于通过曲折的解剖体传送或使支架与弯曲的血管一致。该专利描述了一种带有彼此平行排列的径向可扩展圆柱形元件的支架，散布在这些圆柱形元件之间和连接两个相邻圆柱形元件的是可弯曲的支杆。虽然这种结构能为确定的应用提供所需的支架弹性和弯曲性，但是价格昂贵，制造复杂。
美国专利(专利号：6,572,646，Boylan)揭示了一种由超弹性合金，比如镍-锑(Ni-Ti)合金(Nitinol)，制成的支架，通过一个低温阶段形成支架的第一种形状，通过一个高温阶段形成支架的第二种形状，在长度上有一个弯曲。美国专利(专利号：6,689，162，Thompson)揭示了一种使用几股用以提供力量的金属丝和柔顺的纺织丝的辫子状修复装置。Thompson的目的是提供一种修复装置，结合自我展开支架的结构力量、弹性和移植物的低渗透性。美国专利(专利号：6,656,218，Denardo et al.)描述了一种血管内血流矫正器，即使放置矫正器以后还允许微线圈的导入。
发明内容
本发明的一个方面是提供一种高度柔软可移植的栓塞装置，能容易地穿过神经血管系统的曲折的导管。另外，栓塞装置能容易地与血管系统的曲折的导管的形状一致。而且，该栓塞装置能引导血流不在动脉瘤而在导管里流动；另外，这样的栓塞装置允许充分的血流提供给相邻的组织，以便那些组织，无论是支路血管还是需氧组织，不被剥夺所必需的血流。
该栓塞装置也能改变流向动脉瘤的血流，而仍然维持所需的血流至周围的组织和流在血管中。在这种情况下，仍然有部分血液允许到达动脉瘤，但是不足以在动脉瘤中形成会伤害它的薄壁的层流。实际上，血流是断断续续的，因此，对于在动脉瘤中血凝固或填充材料固化提供了足够的时间。
该栓塞装置足够柔软以最接近自然生长的血管系统，和自然生长血管的自然曲折的路径一致。根据本发明的栓塞装置的最重要的一个特性是它的伸缩和弯曲的能力，因此在脑中呈现血管系统的形状。与冠状支架相比，因为大脑的血管系统更小、更曲折，这些特征是微神经血管栓塞装置特设的。
概括地，本发明的方面涉及治疗动脉瘤的方法与装置。特别地，一种治疗带有颈部的动脉瘤的方法，包括在动脉瘤的位置的导管的内腔展开一个血管栓塞装置，以便血流在动脉瘤的颈口改向。诱导的血流在动脉瘤内腔的停滞会在动脉瘤中形成栓塞。该栓塞装置跨越动脉瘤的茎体宽度以便它阻碍或最小化流向动脉瘤的血液。该栓塞装置在材料与装配上都非常柔软。结果，该栓塞装置能很容易地通过弯曲的血管，特别是在大脑中的血管。因为该栓塞装置是柔软的，使栓塞装置偏转以通过血管系统的血管仅需要很小的力，这对于操作的外科医生非常重要。
除了柔软性，该栓塞装置的重要的一个特征是该栓塞装置可含有一个不对称的辫子状式样，与径向相反表面相比较，在对着动脉瘤的颈部的表面带有更高浓度的编织线或不同大小的编织线。在一个实施例中，面向动脉瘤的表面几乎是不能渗透的，直径上的相对的表面是高度渗透性的。这样一种构造将引导血液离开动脉瘤，但是维持血液流入栓塞装置展开的主血管的旁支。
在另一个实施例中，该栓塞装置沿栓塞装置纵轴有一个不对称的编织数。这为栓塞装置提供了一种自然的弯曲倾向，因此和弯曲的血管保持一致。这减少了栓塞装置施加在血管壁的压力，所以最小化了动脉瘤破裂的可能性。另外，因为栓塞装置自然弯曲，这就不需要微导管的末部弯曲。现在，当弯曲的栓塞装置被放在微导管的末端时，末端形成栓塞装置的弯曲形状。栓塞装置能被预先放置在微导管内，用活塞传送，如果需要，活塞可将栓塞装置推出微导管。栓塞装置能以一种压缩状态被放置在微导管内。一旦脱离微导管，它能展开到现有的内腔的大小，维持内腔的不闭合，并允许血液流过内腔。栓塞装置能有一个格子结构，格子的开口大小沿着栓塞装置的长度可以不同。格子开口的大小可以由用于构造格子的编织数来控制。
根据本发明的方面，采用比如颈部重建或气囊改造的方法，栓塞装置可以被用来在血管内改造动脉瘤。栓塞装置在动脉瘤内能被用来形成屏障限制栓塞材料比如熟知的弹簧圈或粘性流体，比如微治疗法(Microtherapeutics)的“ONYX”，以便导入的材料不会由于位于动脉瘤区域的栓塞装置的格子密度而从动脉瘤中流失。
在本发明的另一方面，揭示了一种用于栓塞动脉瘤的装置。该装置是一种在构件壁上分布有较多穿孔的管状装置。该装置被放在动脉瘤的基部，遮盖住动脉瘤的颈口，以便正常流向动脉瘤瘤体的血液被中断，在那附近产生血栓，最终栓塞动脉瘤。
在本发明的再一方面，该装置是一种辫子状的管状构件。编织成辫子形状的线是带有矩形截面的带状物，带有圆形截面的金属丝或聚合体线。
在另外一个实施例中，制造带有辫子状结构的装置的目的是与身体内弯曲的血管一致，辫子的密度提供足够的刚性和径向力量。另外，该装置能被一种小于10克(grams)的力压缩。这使得该装置能随着动脉壁的跳动很好的顺应动脉。一旦施予一个小于5克/厘米(gram/cm)的力，该装置也能弯曲。
本发明的其它方面包括对应于在这里所描述的装置和系统的方法。
附图说明
通过下面关于本发明的详细描述，结合附图，将使本发明的其他的优势与特点变得非常明显。其中：
图1是动脉瘤，支管及血液流入动脉瘤的示意图。
图2A和图2B是治疗动脉瘤的栓塞装置的一个实施例的图解。
图3是以压缩状态存在于微导管内的图2所示实施例的示意图。
图4A是治疗动脉瘤的栓塞装置的另一个实施例的图解。
图4B和图4C是能用来形成图4A的栓塞装置的带状物部分的横截面示意图。
图5表示以压缩状态存在于微导管的栓塞装置被活塞推出微导管。
图6表示图5所示的压缩栓塞装置在微导管外展开并处于一种展开状态。
图7表示在跨越动脉瘤颈口，分叉和支管的血管的内腔内展开的栓塞装置。
图8是位于血管的内腔的栓塞装置和血流方向改变的示意图。
图9表示一个弯曲力作用于一个传统支架和作用于本发明栓塞装置的效果比较。
图10是通过外作用力变形程度，与传统支架相比较，证明本发明的柔软性。
图11表示提供所期望的弯曲的栓塞装置的辫子状物的不均匀的密度。
图12阐明由于栓塞装置的辫子状物的不均匀密度造成的格子密度或多孔性的差异。
图13表示遮盖动脉瘤颈部的具有变化的格子密度的栓塞装置。
图14和图15表示血管栓塞装置的一个实施例，其格子密度在靠近动脉瘤颈口的纵轴附近是不对称的。
图16举例说明根据本发明的一个实施例的一个具有分叉的栓塞装置，其中具有更小密度的两个栓塞装置结合形成一个单个的分叉装置。
具体实施方式
附图中的装置是用来治疗动脉瘤的。通常，使用微导管，在打算治疗的大脑动脉瘤的位置，展开它们。在2005年5月25日申请的美国专利“在血管中传送和展开栓塞装置的系统与方法”(档案号：006258.00008)中揭示了这样一个系统，在这里，该专利申请作为参考文件整个并入。根据本发明的方面，血管内栓塞装置的实施例对于治疗通常用外科手术夹，微线圈或其它栓塞装置治疗的大脑动脉瘤是有用的。
图1表明了大脑中的一个典型的大脑动脉瘤10。动脉瘤10的颈部11能有代表性的定义为约2-25mm的开口。可以理解，颈部11连接血管13和动脉瘤10的内腔12。从图1中可以看出，在血管13中的血流1通过内腔12进入动脉瘤。对应源源不断流入动脉瘤的血流，内腔12的壁14持续扩张，呈现严重的破裂危机。当在动脉瘤10中的血液产生大于壁强度的对壁14的压力时，动脉瘤破裂。本发明能够防止这样的破裂。图1中还显示分叉15和支管16。
图2阐明了与本发明一个方面一致的一个血管栓塞装置20的实施例。在描述的实施例中，栓塞装置20有一个完全的管状结构22，该管状结构有一个外表面21，一个内表面24和一个处于表面21和24之间的薄壁。很多开口23穿过表面21和24，允许流体从栓塞装置20内部流向血管壁。栓塞装置20是径向可压缩的和纵向可调节的。
图3表示在病人的血管系统中的一个微导管25和在释放前在微导管25中处于压缩状态的栓塞装置20。
图4阐述栓塞装置30的另一个实施例，其具有两股或更多的材料31，32以螺旋状方式缠绕。以这种方式的这种材料的编织导致一种晶格结构33。可以理解，格子33和形成的空隙34的尺寸，至少是部分，由线材料的厚度，股数和栓塞装置30的每单位长度的螺旋数所确定。
栓塞装置30是径向可压缩的和在不需要额外的径向上的扩张力比如膨胀的气囊时，径向可扩张的。通过在相反方向上缠绕两股线31，32构建栓塞装置30。在一个实施例中，线31，32是矩形带状物的形状(见图4C)。带状物可以由已知的柔软材料，包括形状记忆材料，比如镍，铂和不锈钢，加工而成。
用作线31，32的编织材料的带状物包括一个矩形横截面35(图4C)。如图4C和图7所示，与表面36，37之间(厚度)的壁38相比，结合血管内壁的表面36具有一个更长的尺寸(宽度)。对于相同的壁厚，带有矩形横截面的带状物比带有环形的(圆形的)横截面的金属丝具有一个更强的恢复(扩张)力。另外，扁平的带状物允许栓塞装置20更紧凑的压缩，展开时对血管壁产生更少的损伤，因为它在一个更大的表面区域上散布径向的扩张力。相似的，与圆形金属线装置相比，在给定格子密度的情况下，扁平的带状物形成一个更柔软的装置，因为它们的表面区域(宽度)在给定厚度的情况下更大。
虽然有附图的实施例揭示了一种带有长度大于厚度的矩形横截面的带状物，所揭示的栓塞装置的另一个实施例中的带状物可以包括一个正方形的横截面。在另外一个可选择的实施例中，带状物的第一部分可以包括矩形横截面的第一种形式，带状物(图4B)的第二部分39可以包括一个圆的，椭圆的，卵形的或者可选择的其它形式的矩形横截面。例如，带状物的末端截面可以是完全圆的或卵形的横截面，带状物的中间截面可以是一个矩形横截面。
在另一个可选择的实施例中，通过缠绕两股以上的带状物能够形成栓塞装置30。在一个实施例中，栓塞装置30能包括多达16股的带状物。通过使用用于制造径向扩张支架的标准技术，可以制造一种带有大于带状物厚度或金属丝直径的空隙34的栓塞装置30。带状物可以有不同的宽度。在这样一个实施例中，不同的带状物可以有不同的宽度以提供栓塞装置30和血管壁结构上的支撑。根据所揭示的实施例的带状物也能由不同的材料组成。例如，一条或更多的带状物能由一种不会引起排斥的金属材料，比如在这里所揭示的材料，加工而成，并且一条或更多的带状物能由一种不会引起排斥的聚合体加工而成。
图5表示一种以径向压缩状态位于微导管25中的血管内栓塞装置30。在一个实施例中，栓塞装置30能被物理连接在微导管的末端。这可以通过把栓塞装置30限制在微导管的远端部分来实现。使用活塞50，微导管25在一根导线上(未图示)缓慢前进，并且当微导管25的末端到达动脉瘤时，栓塞装置从末端被释放出来。栓塞装置30展开至血管的尺寸，并且栓塞装置30的表面现在与血管壁15面对面，如图6所示。在上面提到的申请文件中揭示了传送和展开栓塞装置30的器械与方法。
参见图7，栓塞装置30在带有动脉瘤10的大脑血管13的内腔内展开。展开时，栓塞装置30的近端43安全的靠着分叉15前的血管13的内腔壁，而栓塞装置30的远端45则安全的靠着超过动脉瘤10的颈部11的血管13的内腔壁。在栓塞装置30被合适地放置于血管13内的期望位置之后(比如，见图7)，动脉瘤10的内腔中的流动显著变小，而血管13中的轴流没有显著妥协，部分地是由于壁38的最小的厚度。
流进动脉瘤10的流量由带状物的格子密度以及由此引起的表面覆盖度来控制。拥有更大的格子密度的区域将具有减少的径向(横向)流。反过来，拥有更小的格子密度的区域将允许显著的径向流通过栓塞装置30。如下面所讨论的，栓塞装置30能有不同密度的纵向扩充的(横向的)区域。在每一个区域内，它们圆周的密度可以是不变的或变化的。这提供了不同程度的流动通过相邻的边区。在带有较大密度的区域的血管中的位置可以用射线照相术的方式(radiographically)确定，以便能确定栓塞装置30对于动脉瘤10和任何血管旁支15，16的相对位置。栓塞装置30也可以包括辐射透不过的标志(radiopaque markers)。
在动脉瘤10内的血流的减少导致对壁14的力的减少，及血管破裂危险的相应的减少。当进入动脉瘤10的血液的力量和体积被栓塞装置减少时，进入动脉瘤10的层流停止，动脉瘤中的血开始停滞。血液停滞，与流经动脉瘤10的内腔12的连续不断的血流相反，在动脉瘤10中导致血栓。这也保护动脉瘤防止破裂。另外，由于栓塞装置30在分叉15部分的密度，栓塞装置30的开口(空隙)34允许血流继续流入血管的分叉15和支管16。如果分叉15在动脉瘤15的下游，如图8所示，栓塞装置30的存在仍然引导血液不流入动脉瘤10，而流入分叉15。
在这里所描述的栓塞装置拥有与血管系统的曲率保持一致所需的柔软性。这与冠状支架相反，因为冠状支架使得血管系统与它们的形状基本一致。与冠状支架相比，与血管系统的形状保持一致的能力对于神经血管栓塞装置尤为重要，因为大脑中的血管系统更小，更曲折。表1和表2证明这些声称的神经血管系统栓塞装置的这些特征。为了证明所揭示的栓塞装置表现出非常符合期望的弯曲特征，进行了下面的实验。由发明人制造的栓塞装置置于一个支撑表面90，如图9所示。剩下大约0.5英寸的栓塞装置30没有被支撑。然后，在未支撑点作用一个大小可测的力直到栓塞装置偏离起始点90度。用同样的弯曲力矩作用一个商业上可获得的冠状支架的相似的长度。结果见表1。与减少的压缩力相似，本发明的栓塞装置需要低一个数量级的弯曲力矩(0.005磅每英寸和冠状支架的0.05磅每英寸相比)。
表1：弯曲栓塞装置产生的0.5英寸悬臂所需的弯曲力
 
冠状支架商业上可获得的支架 0.05磅每英寸
神经血管栓塞支架(30) 0.005磅每英寸
与冠状支架相比，根据本发明的栓塞装置也提供增强的压缩性(例如，对于一个给定的力能获得多少压缩，或达到一个期望的压缩需要施加多少的力)。与一个高度可压缩的装置相比，一个不能高度压缩的血管内装置将在血管壁上施加更大的力。这在大脑血管系统是有重要临床影响的，因为具有低压缩性的血管内装置是有害的。
表2：压缩栓塞装置至原来直径的50％所需的压缩力(见图10)
 
冠状支架(商业上可获得的) 0.2磅(1b)
神经血管栓塞支架(30) 0.02磅(1b)
图11至图13显示栓塞装置60的一个实施例，其中栓塞装置60的格子结构63在栓塞装置60的长度上不均匀。在栓塞装置60的可能是在动脉瘤的颈部展开的中间部分65，格子密度63A有意识的增加到一个数值显著高于栓塞装置60的其它地方的格子密度。比如，见图11，格子密度63A是显著高于相邻部分64的格子密度63。在一个极端，格子密度(由空隙提供的多孔性)可以为零，也就是说，栓塞装置60完全不可渗透。在另一个实施例中，中间部分65的格子密度63A可以是大约50％，而栓塞装置的其他部分64的格子密度是大约25％。图12显示处于弯曲形状的这样的栓塞装置60，图13表示在一个血管内腔展开的栓塞装置60。图13也显示置于动脉瘤10的颈部的栓塞装置60的带有增加的格子密度63A的部分。对所有揭示的栓塞装置，栓塞装置60的至少一部分的格子密度可以在约20％和80％之间。这些实施例的格子密度可以在约25％和50％之间。
栓塞装置300的另一个实施例如图14和图15所示。在这个实施例中，栓塞装置300在带有动脉瘤的血管的内腔被展开。栓塞装置300包括一个面向动脉瘤内腔的表面310。这个表面310有一个与直径上的对立表面320相比显著高的格子密度(更小的和/或更少的空隙)。由于表面310的高格子密度，流入动脉瘤内腔的血液更少。然而，由于对着旁支的表面320的格子密度没有减少，对于血液流入旁支没有负面影响。
任何在这里被披露的栓塞装置能与第二个栓塞装置一起使用以创建一个分叉的栓塞装置400，如图16所示。这个装置可以在体内创建，在形成栓塞装置400时，带有低密度的第一栓塞装置410的一部分可以与同样带有低密度的第二栓塞装置420的一部分结合。栓塞装置410，420可以是在这里所讨论的任何一个。在这两个栓塞装置410，420的这些部分以交织方式结合形成一个交织区425后，剩下的部分414，424能在不同方向分叉，从而沿着分叉的两条支路延伸。交织区425外的区域可以有更大的格子密度以治疗动脉瘤或更小的格子密度以允许血液流入血管的支路15，16。
任一所揭示的栓塞装置的格子密度可以是它的栓塞装置的表面区域的约20％至约80％。在一个实施例中，格子密度可以是它的栓塞装置的表面区域的约20％至约50％，在另一个实施例中，格子密度可以是它的栓塞装置的表面区域的约20％至约30％。
一台带有用0.005英寸宽的带状物编织的，每英寸30梭(picks per inch，PPI)(每英寸接触交叉数或接触点数)，外直径0.09英寸的16股的典型的栓塞装置大约有30％的格子密度(带状物覆盖的表面)。在这里揭示的实施例中，带状物可以是大约0.001英寸厚，宽约0.002英寸至约0.005英寸。在一个实施例中，带状物厚度约0.004英寸。对于约0.001英寸厚，约0.004英寸宽的含16股线的带状物，50PPI，40PPI和30PPI的覆盖将会分别大约有40％，32％和24％的表面覆盖。对于约0.001英寸厚，约0.005英寸宽的含16股线的带状物，50PPI，40PPI和30PPI的覆盖将会分别大约有50％，40％和30％的表面覆盖。
在选择带状物的尺寸时，必须考虑到，当把带状物捆扎起来时，它们将穿过一根微导管。比如，16股0.006英寸宽的带状物可能不能通过内直径不超过0.027英寸的微导管。可是，随着带状物的宽度变小，恢复力成比例减小。
虽然可以使用其它的线的几何形状，这些其它的几何形状，比如圆形，由于它们的厚度尺寸，将会限制装置。例如，0.002英寸直径的圆金属丝将在血管中占到0.008英寸的横截面空间。这样的空间能影响和中断血流通过血管。血管中的流动能被直径的这种改变打断。
尽管详细的描述含有很多的细节，但是这些不应当解释为对发明范围的限制，而仅仅是为了阐明本发明的不同例子和方面。应该理解本发明的范围包括未在上面详细讨论的其它实施例。对本领域技术人员来说，可以在这里所揭示的本发明的方法与仪器的装配，操作和细节方面做出各种各样的明显的其它的修改，改变和变化而不背离所附的权利要求所限定的本发明的精神和范围。因此，本发明的范围应当由所附的权利要求和它们的合法的等同物所确定。进一步地，不管该元件，部件或方法步骤是否清楚的在权利要求中叙述，没有元件，部件或方法步骤会开放供公众使用。
在权利要求中，除非清楚说明，以单数引用的元件并不意味着“一或只有一”，而是意味着“一或更多”。另外，对于一种仪器或方法去解决每个由本发明的不同实施例解决的问题以被权利要求所包括，这是不必要的。

Claims (23)

1.一种放置于血管内栓塞动脉瘤的装置，其特征在于，所述装置包括许多编织的带状物，所述每一带状物包括一个内表面，一个靠着血管内壁的外表面，所述外表面在所述装置的第一末端和第二末端之间形成所述装置的外圆周的一部分，和穿透所述内外表面之间的很多开口，所述装置的所述外表面组成大约20％至大约50％所述装置的所有外圆周区域。
2.如权利要求1所述的装置，其特征在于，所述开口占据大约50％至大约80％所述装置的所有外圆周区域。
3.如权利要求1所述的装置，其特征在于，所述带状物沿所述装置的长度形成一种格子结构。
4.如权利要求3所述的装置，其特征在于，所述格子结构的密度在每英寸大约25梭至大约50梭之间。
5.如权利要求1所述的装置，其特征在于，所述装置有一段范围，带有一种格子密度的第一部分限制液体从相对于所述范围的一个角度在一个方向上流过那里，带有一种格子密度的第二部分，相对于所述第一部分，在所述方向上允许更多的液体流过那里。
6.如权利要求1所述的装置，其特征在于，所述带状物有一个完全矩形的横截面。
7.如权利要求1所述的装置，其特征在于，所述带状物被编织以便形成一种带有置于血管内的预先确定位置的不同格子密度区域的格子结构。
8.如权利要求7所述的装置，其特征在于，所述格子密度在第一圆周延伸区域大于所述格子密度在所述第一区域轴向分隔的第二圆周延伸区域。
9.如权利要求1所述的装置，其特征在于，所述装置是分叉的，以便所述装置第一末端包括一个第一轴向开口，所述装置第二末端包括至少二个轴向开口。
10.如权利要求9所述的装置，其特征在于，所述分叉装置在体内由至少两种所述装置的部分编织在一起而形成。
11.如权利要求1所述的装置，其特征在于，包含展开时可调节的一段范围，以便当栓塞装置被放进一个传送导管内后，可以调节栓塞装置的展开长度。
12.如权利要求1所述的装置，其特征在于，包含置于接近血管的旁支或支流部分的区域，所述区域，相对于打算被放置于动脉瘤附近的区域，拥有更小的格子密度。
13.一种用于栓塞部分血管的辫子状装置，其特征在于，包含一个有不对称辫子状式样的延长柔软构件，其中所述辫子状式样的第一部分允许第一级数量的径向血流通过那里，所述辫子状式样的第二部分允许第二级数量的径向血流通过那里，所述第一级数量大于所述第二级数量。
14.如权利要求13所述的装置，其特征在于，所述辫子状式样拥有一种占大约20％至大约50％所述装置表面区域的格子密度。
15.如权利要求13所述的装置，其特征在于，所述辫子状式样由含有一个完全矩形的横截面的至少一个第一部分的交织带状物形成。
16.如权利要求15所述的装置，其特征在于，所述辫子状式样沿所述装置长度上形成一个每英寸大约25梭至大约50梭之间的格子密度。
17.如权利要求16所述的装置，其特征在于，所述第一和第二部分包括不同的格子密度。
18.如权利要求13所述的装置，其特征在于，所述第一部分包括一个第一圆周延伸区域，所述第二部分包括一个与所述第一区域轴向分隔的第二圆周延伸区域。
19.如权利要求13所述的装置，其特征在于，所述第一部分包括一个第一轴向延伸区域，所述第二部分包括一个与所述第一区域圆周分隔的第二轴向延伸区域。
20.如权利要求13所述的装置，其特征在于，所述装置是分叉的，以便所述装置的第一末端包括一个第一轴向开口，所述装置的第二末端包括至少两个轴向开口。
21.如权利要求20所述的装置，其特征在于，所述分叉装置在体内通过将至少两种所述装置的部分编织在一起形成。
22.如权利要求13所述的装置，其特征在于，包含展开时可调节的一段范围，以便当栓塞装置被放进一个传送导管内后，可以调节栓塞装置的展开长度。
23.如权利要求13所述的装置，其特征在于，包含置于接近血管的旁支或支流部分的区域，所述区域，相对于打算被放置于动脉瘤附近的区域，拥有更小的格子密度。
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US8398701B2 (en) 2013-03-19
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