CN101472536B - 柔软的血管闭塞装置 - Google Patents

柔软的血管闭塞装置 Download PDF

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CN101472536B
CN101472536B CN2007800232295A CN200780023229A CN101472536B CN 101472536 B CN101472536 B CN 101472536B CN 2007800232295 A CN2007800232295 A CN 2007800232295A CN 200780023229 A CN200780023229 A CN 200780023229A CN 101472536 B CN101472536 B CN 101472536B
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aneurysm
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阿德里安·加西亚
婷·蒂娜·叶
广·Q·德兰
阿龙·L·别列兹
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Abstract

一种用于调整血管内血液流动同时保持血液流向周围组织的血管闭塞装置。该闭塞装置包括一柔软的、易压缩和弯曲的闭塞装置，其特别适合用于治疗大脑中的动脉瘤。该神经血管闭塞装置可用微导管来安置。闭塞装置可通过螺旋方式编织金属线来形成，并可以沿闭塞装置的长度方向具有不同的网格密度。闭塞装置也可以在相同径向平面的表面上具有不同的网格密度。

Description

柔软的血管闭塞装置
相关申请
本申请是2005年5月25日提交的美国申请11/136,395的部分继续申请和对其要求优先权，该美国申请主张享有2004年5月25日提交的申请号为60/574,429、名称为“柔软的血管假体”的美国临时申请的利益。这些申请的每一个通过参考其全部在这里明确纳入。
发明领域
本发明大体涉及一种可移植装置，其可以用在血管系统中去治疗常见的血管畸形。更具体地，其涉及一种柔软的、生物相容的装置，其可以被导入病人的血管系统去栓塞和闭塞动脉瘤(aneurysms)，特别是脑动脉瘤(cerebral aneurysms)。
发明背景
血管系统的管壁，特别是动脉管壁，可能形成称为动脉瘤的病理扩张。通常观察到动脉瘤是动脉管壁的囊状突出。这是血管管壁被疾病、伤害或先天性畸形削弱的结果。动脉瘤具有薄弱的管壁，有破裂趋势，往往被高血压导致或使得恶化。动脉瘤可以在身体的不同部位发现；最常见的是腹部大动脉瘤(abdominal aortic aneurysms，AAA)和大脑或脑动脉瘤。仅仅存在动脉瘤并不总是危及生命，但如果在大脑中破裂，它们可能产生严重的健康后果，如中风。此外，众所周知，破裂的动脉瘤也可导致死亡。
最常见的脑动脉瘤被称为囊状动脉瘤(saccular aneurysm)，通常发现于血管的分叉处。分叉点，Y中V的底部，可以被血流的血液流动力削弱。在组织学水平，动脉瘤是通过损伤动脉管壁中的细胞所导致。损伤被认为是由于血液流动的剪应力所产生。剪应力产生热量来毁坏细胞。这种在血管壁的血液流动力，可能与血管壁的内在异常相结合，被认为是脑动脉的这些囊状动脉瘤起源，发展和破裂的根本原因(Lieber and Gounis，The Physics of Endoluminalstenting in the Treatment of Cerebrovascular Aneurysms，Neurol Res 2002：24：S32-S42)。在组织学研究中，损伤的内膜细胞相对于圆形健康细胞被拉长。作为动脉的几何形状和血液的粘度、密度和速度的函数，剪应力在心动周期的不同阶段、在动脉管壁的位置和在不同个体中可以有很大的不同。一旦动脉瘤形成，在动脉瘤中的血液流动的波动是至关重要的，因为它们可能引起动脉瘤管壁的震动，其有助于发展和最终破裂。关于上述概念的更详细地描述见，例如，Steiger，Pathophysiology of Development and Rupture of Cerebral Aneurysms，Acta NeurochirSuppl 1990：48：1-57；Fergueson，Physical Factors in the Initiation，Growth and Rupture of HumanIntracranial Saccular Aneurysms，J Neurosurg 1972：37：666-677。
动脉瘤通常是通过从动脉循环中去除血管的削弱部分来治疗。对于治疗脑动脉瘤，这样的加强采用很多方式进行：(i)外科手术夹闭，其中金属夹固定在动脉瘤的底部；(ii)用微线圈包裹动脉瘤，微线圈是小的、柔软的金属丝线圈；(iii)用栓塞材料去“填充”动脉瘤；(iv)采用可拆卸的气囊或线圈去闭塞供给动脉瘤的载瘤血管；和(v)血管内支架成形术。对于这些不同的方法的全面的讨论和回顾见Qureshi，Endovascular Treatment ofCerebrovascular Diseases and Intracranial Neoplasms，Lancet.2004 Mar 6；363(9411)：804-13；Brilstra et al.Treatment of Intracranial Aneurysms by Embolization with Coils：A SystematicReview，Stroke 1999；30：470-476。
由于微创介入技术得到更多名望，基于微导管的用于治疗神经血管动脉瘤的方法正变得越来越普遍。微导管，无论是血流导引或金属丝导引，用于发送栓塞材料、微线圈或其它结构(如，支架)用于栓塞动脉瘤。微线圈可通过微导管通过和用机械或化学分离机制设置在动脉瘤中，或将其部署到载瘤血管中永久闭塞它从而阻止血液流入动脉瘤。可选择的，支架可通过神经血管至期望位置。Pereira的文章，History of Endo vascular Aneurysms Occlusion inManagement of Cerebral Aneurysms；Eds：Le Roux et al.，2004，pp：11-26，提供了关于动脉瘤检测和治疗替代方案历史的极好背景。
正如许多上述基于脑动脉瘤的起源、形成和破裂的文章提到的，很显然，动脉瘤治疗的目标是减少动脉瘤破裂的风险，从而减少蛛网膜下腔出血的后果。还应当注意，虽然防止血液流入动脉瘤是非常可取的，以便动脉瘤的被削弱的管壁不会破裂，血液流入周围结构并不被用于阻碍血液流动至动脉瘤的方法所限制也可能是至关重要的。研发的用于治疗身体中的其它血管畸形的常规支架并不适合栓塞脑动脉瘤。当高氧消耗者，如脑组织，被剥夺所需要的血流时，可能导致所有常见的并发症。
用于治疗神经血管动脉瘤的现有方法有许多缺点。神经血管的血管是身体中最弯曲的；无疑比冠状循环的血管更加弯曲。因此，对于外科医生来说，使有时用在神经血管中治疗动脉瘤的坚硬的冠状动脉支架通过神经血管是一个挑战。假体的弯曲力表明假体通过神经血管的可操作性；与具有更高弯曲力的假体相比，较低的弯曲力将意味着假体更容易通过神经血管。一个典型的冠状动脉支架的弯曲力是0.05lb-in(将0.5英寸悬臂弯曲至90度的力)。因此，拥有比现有的支架更加柔软的神经假体将是有用的。
现有的支架结构，无论是用于冠状血管或神经血管(微线圈)，通常都是笔直的，通常从笔直的管形材料或坚硬金属材料的编织物通过激光切割而来。然而，大多数血管是弯曲的。因此，目前的支架结构和微线圈当它们尽量弄直弯曲的血管壁时施加重大压力在血管壁上。对于削弱的血管壁，尤其具有动脉瘤形成倾向的，这可能具有灾难性的后果。
如前所述，施加在血管、尤其是分叉点的血液流动力导致血管壁的削弱。该压力最重要的来源是血液流动的突然改向。因此，如果去尽量减少血液流动的突然改向，特别是在血管削弱处，这将是有益的。
现有的闭塞动脉瘤的办法可能导致另一系列问题。通过用栓塞材料(线圈或液体聚合物)包裹或填充动脉瘤来仅仅闭塞动脉瘤的方法不能解决基本的有助于动脉瘤形成的流动异常。
支架结构被置于腔内的球囊导管上后可以展开。可选择的，自我展开架干可以以压缩状态插入，一旦放置好即展开。对于球囊展开支架，支架安装在导管远端的球囊上，推进导管至期望位置，球囊充气从而展开支架至永久展开状态。然后，球囊放气，并撤回导管留下展开的支架去维持血管通畅。由于潜在的切开或破裂脑内血管的致命后果，在大脑内使用球囊展开支架充满了问题。球囊展开支架的适当展开需要过度展开安装支架的球囊使支架嵌入血管壁，误差要小。球囊展开支架也不合适用于适应脑血管的自然尖端，其越接近末梢越细。如果支架从载瘤血管放进较小的分支血管，血管之间直径的变化使得难以安全放置球囊展开支架。自我展开支架，在压缩或压扁的支架是由外部限制鞘在压缩支架外来保持压缩状态直到展开。在展开时，限制外鞘被收回从而暴露压缩支架，然后支架展开以保持血管开放。此外，与用于传递大的冠状动脉支架至冠状动脉的较大导管相比，用于传递这种假体采用的导管是具有外径0.65毫米至1.3毫米的微导管。
美国专利US6,669,719(Wallace et al.)描述了用于颅内使用的支架和支架导管。卷起的薄板支架可释放地安装在导管的远端。一旦卷起的薄板支架置于动脉瘤，支架被释放。这导致立即和完全隔离动脉瘤和周围的循环系统的分支血管和使血液改向远离动脉瘤。这样一个系统的一个重大的缺点是在支架展开后，周围的循环系统的分支血管，与目标动脉瘤一起，被剥夺了所需要的血流。
美国专利US6,605,110(Harrison)描述了用于通过弯曲的解剖体或用于使支架符合弯曲血管的自我展开支架。这项专利描述了一支架结构，带有径向可展开的圆柱元件，其相互平行排列，散布在这些元件之间连接两相邻圆柱元件的是可弯曲的支柱。虽然这种结构能够提供支架的必要的柔软性和可弯曲性用于某些应用，其是制造昂贵和复杂的。
美国专利US6,572,646(Boylan)披露了一种支架，其由一种超弹性合金制成，如镍钛的合金(镍钛诺)，在低温阶段诱导支架的第一形状和在高温阶段诱导支架的沿着长度弯曲的第二形状。美国专利US6,689,162(Thompson)披露一编织假体，其使用了用于提供力量的金属线，和柔顺的纺织线。美国专利US6,656,218(Denardo et al.)描述了一种血管内流动调节器，其允许微线圈导入。
发明内容
本发明的一个方面提供了一种高度柔软的可植入闭塞装置，可以轻松穿过神经血管的弯曲血管。此外，闭塞装置可以很容易地符合神经血管的弯曲血管的形状。而且，闭塞装置可以在血管内引导血流远离动脉瘤；另外这种闭塞装置允许充分的血流提供给邻近结构以便那些结构，无论它们是分支血管或需氧组织，不被剥夺必需的血流。
闭塞装置也能够改变流至动脉瘤的血流，而仍然维持所需的血流至周围组织和血管中。在这种情况下，一些血液仍然允许到达动脉瘤，但不足以在动脉瘤内形成会对其薄壁造成伤害的层流。事实上，流动将是间歇的，从而提供足够的时间在动脉瘤内进行血液凝结或填充材料固化。
闭塞装置足够柔软以接近天然血管系统和符合天然血管的自然弯曲路径。根据本发明的闭塞装置的其中一个显著特点是它能够伸缩和弯曲，从而在大脑内呈现血管系统的形状。与冠状动脉支架相比，这些特征是用于血管系统闭塞装置的，因为大脑中的血管更小、更弯曲。
概括地，本发明的方面涉及用于治疗动脉瘤的方法和装置。具体地，一种治疗带颈部的动脉瘤的方法包括在动脉瘤位置的血管管腔内设置血管闭塞装置，从而血液流动改变方向远离动脉瘤颈部。动脉瘤腔中诱导的血液停滞会在动脉瘤中造成栓塞。闭塞装置跨越动脉瘤的茎干宽度，以便它妨碍或最大限度地减少血液流至动脉瘤。闭塞装置在它的材料和它的设置两方面都是非常柔软的。结果是，闭塞装置可以很容易地通过弯曲的血管，特别是在大脑中的那些血管。因为闭塞装置是柔软的，需要很小的力去使闭塞装置转向以穿过神经血管的血管，这对于外科手术医生具有重要意义。
除了其柔软性外，闭塞装置的一个特征是闭塞装置可以具有不对称编织样式，与径向相对的表面相比，在朝向动脉瘤颈部的表面上具有更高的编织线浓度或不同的编织线尺寸。在一具体实施例中，面向动脉瘤的表面几乎是不透水的，与此相反的表面是高度可渗透的。这样的结构将引导血流远离动脉瘤，但维持血液流至设置有闭塞装置的主干血管的分支血管。
在另一具体实施例中，闭塞装置沿闭塞装置的纵轴具有不对称编织数。这提供了闭塞装置弯曲的自然趋势，因此，符合弯曲的血管。这减少了由闭塞装置施加在血管壁上的压力，从而最大限度减少动脉瘤破裂的可能性。此外，由于闭塞装置是自然弯曲的，这无需将微导管的尖端弯曲。现在，当弯曲的闭塞装置装在微导管的尖端上，尖端呈现闭塞装置的弯曲形状。闭塞装置可以预先安装在微导管内，可通过使用活塞来传递，活塞在需要时将把闭塞装置推出微导管。闭塞装置可以以压缩状态放置在微导管内。一旦退出微导管，它可以展开至存在的管腔的尺寸，并保持管腔开放，允许血流通过管腔。该闭塞装置可以具有网格结构，网格的开口大小可以沿闭塞装置的长度而不同。网格开口的大小可以由用于构成网格的编织数控制。
根据本发明的一个方面，通过，例如，颈部重建或球囊重塑，闭塞装置可用于改变在血管内的动脉瘤。由于闭塞装置在动脉瘤区域中的网格密度，闭塞装置可用于形成将闭塞材料保留在动脉瘤内的障碍物，以便导入的材料将不会从动脉瘤内漏出。
在本发明的另一方面，披露了用于闭塞动脉瘤的装置。该装置是一个管状元件，带有多个穿孔，分布在元件壁上。该设备放置在动脉瘤的底部覆盖动脉瘤颈部以便使正常流向动脉瘤主体的血流中断，从而产生血栓，并最终闭塞动脉瘤。
在本发明的另一方面，装置是一个编织管状元件。编织线是具有矩形横截面的条带、具有圆形横截面的金属丝或高分子线。
在另一具体实施例中，为了符合身体内弯曲的血管，制造了具有编织结构的装置，其中编织物密度提供了足够的硬度和径向力。此外，该装置可使用小于10克的力压缩。这使得当动脉管壁鼓动时该装置顺从动脉。并且，一旦施加小于5克/厘米的力，该装置能够弯曲。
本发明的其它方面包括在此描述的与装置和系统相应的方法。
附图说明
本发明具有其它的优势和特点，从本发明的下面的详细说明和所附的权利要求，并结合附图，将变得更加明显，其中：
图1是动脉瘤、分支血管和血液流动至动脉瘤的示意图。
图2A和2B表示用于治疗动脉瘤的闭塞装置的一具体实施例。
图3是图2所示的具体实施例以压缩状态位于微导管内的示意图。
图4A是治疗动脉瘤的闭塞装置的又一具体实施例。
图4B和4C表示可用于形成图4A所示的闭塞装置的条带部分的横截面。
图5表示以压缩状态位于微导管内的闭塞装置用活塞推出微导管。
图6表示图5所示的压缩的闭塞装置设置在微导管外并处于展开状态。
图7表示在血管管腔内跨越动脉瘤颈部、一个分叉和分支血管的设置的闭塞装置。
图8是显示位于血管管腔中的闭塞装置和血液流动方向变化的示意图。
图9表示与本发明的闭塞装置相比弯曲力作用在传统支架上的效果。
图10通过作用力导致的变形程度说明与传统支架相比本发明的柔软性。
图11显示提供期望的弯曲闭塞装置的编织物的不均匀密度。
图12说明由于闭塞装置的编织物的不均匀密度，在网格密度或孔隙度上的差异。
图13表示覆盖动脉瘤颈部的具有不同网格密度的闭塞装置。
图14和15表示血管闭塞装置的一具体实施例，其中网格密度在动脉瘤颈部附近沿纵轴是不均匀的。
图16说明根据本发明的一具体实施例的分叉的闭塞装置，其中具有较小密度的两闭塞装置组合在一起形成单一分叉装置。
图17说明在闭塞装置中网格的网状样式的一个例子。
图18说明在闭塞装置中网格的编织元件的一个例子。
图19说明在闭塞装置中另一编织元件的一个例子。
图20说明适合血管直径的闭塞装置的编织元件。
图21是保护线圈的一个例子的横截面视图。
图22说明确定保护线圈或传递装置中的闭塞装置的条带尺寸的一个例子。
图23说明确定保护线圈或传递装置中的闭塞装置的条带尺寸的另一个例子。
图24说明基于条带数量确定条带宽度的一个例子。
图25说明血管中闭塞装置的PPI和自由站立状态的闭塞装置的PPI的关系。
图26说明适于保护线圈的最大条带尺寸的一个例子。
图27是表示闭塞装置中编织元件的开口大小作为网格结构的PPI的函数的图形。
图28表明血管中的PPI作为32条带闭塞装置的编织PPI的函数。
图29表明对于32条带闭塞装置，覆盖百分数作为编织PPI的函数。
图30表明对于32条带闭塞装置，闭塞装置中编织元件的开口大小作为网格结构的编织PPI的函数。
优选实施例详细描述
在附图中显示的装置是打算用于治疗动脉瘤的。它们一般使用微导管设置在打算治疗的脑动脉瘤位置。这样一个系统被披露在与此有关尚待批准的美国专利申请，名称为“用于在血管中传递和设置闭塞装置的系统和方法”，美国申请号11/136,398，在2005年5月25日申请，其作为整体进行参考在此纳入。根据本发明的方面的血管内闭塞装置的具体实施例用于治疗通常采用外科手术夹、微线圈或其它栓塞装置治疗的脑动脉瘤是有用的。
图1说明大脑中一个典型的脑动脉瘤10。动脉瘤10的颈部11典型地能够限定约2～25mm之间的开口。正如理解的那样，颈部11连接血管13和动脉瘤10的管腔12。从图1中可以看出，血管13中的血流1是通过管腔12和进入动脉瘤的。为了适应血液不断流入动脉瘤，管腔12的管壁14持续扩张，出现破裂的重大危险。当动脉瘤10中的血液导致作用于管壁14的压力超过管壁强度，动脉瘤破裂。本发明可以防止这种破裂。分叉15和分支血管16也显示在图1中。
图2说明与本发明的一个方面一致的血管闭塞装置20的一具体实施例。在说明的具体实施例中，闭塞装置20具有基本的管状结构22，由外表面21、内表面24和在表面21和24之间延伸的薄壁限定。多个开口23延伸在表面21和24之间，允许液体从闭塞装置20的内部流至血管壁。闭塞装置20径向可压缩和纵向可调。
图3显示微导管25和在被释放在病人的血管系统内之前以压缩状态位于微导管25内的闭塞装置20。
图4说明闭塞装置30的另一具体实施例，具有以螺旋方式缠绕的两或更多成股材料31和32。以这种方式编织这种材料导致网格结构33。可以理解，网格33的尺寸和形成的空隙34，至少部分，由成股材料的厚度、股数和闭塞装置30每单位长度螺旋数确定。例如，空隙34和/或网格33的尺寸可以由以螺旋方式缠绕的成股材料31和32的数目确定。在一个例子中，可以使用多达16根编织条带的任何数量的编织条带(例如，5、8、10、13、15或16根编织条带)。在另一个例子中，可以使用16-32根编织条带(例如，20、23、25、27、30或32根编织条带)。在另一个例子中，可以使用大于32根编织条带比如，举例，35、40、48、50、55、60、80、100，或更多编织条带。然而，其它数值是可能的。
因此，成股材料，如条带，可交叉形成编织样式。成股材料的交叉可以径向或轴向形成在成形装置(forming device)比如编织轴(braiding mandrel)的表面。例如，当成股材料的交叉是沿轴向路径时，交叉材料可在固定或可变频率。作为一个成股材料以固定频率交叉的例子，交叉的成股材料可沿成形装置(例如，编织轴)表面任何1.0英寸轴向路径来表示纬密(pick count)。当成股材料的交叉是沿径向路径或圆周路径时，成股材料的间距可以是一致或变化分布的。在一个成股材料沿径向或圆周路径且间距是均匀分布的例子中，沿径向的间距可以基于下列公式确定：
方程式(1)：(π)*(成形装置的直径)/(条带数/2)
图18说明在径向和PPI(纬密，picks per inch)方向的编织元件或单元的一个例子。编织物的任何单一元件(即编织元件)可以结合在一起以在成形装置(例如，编织轴)的表面形成如图17所示的网状样式。该编织物能阻碍或干扰脉管(如血管)中液体(如血液)的流动。当闭塞装置设置在血管中时，编织或网格样式、密度、形状等可至少部分确定血管中的流动。编织物或网格的每个参数也可以被使用者控制去控制流动。
用于确定通过含有网格样式、密度、形状等的闭塞装置的流动的参数包括闭塞装置的表面覆盖度和编织或网格样式的单元大小。这些参数每个可以进一步显示编织物或网格的几何特征。表面覆盖度可被确定为(表面积)/(总表面积)，其中表面积是框架或固体元件的表面积，总表面积是整个元件(即框架和开口)的。
单元大小可被确定为限定单元开口的最大长度。增加表面覆盖度同时降低单元大小的编织样式可能对破坏或阻碍流经编织物或网格的流动具有增强效果。通过改变成股材料(如条带)的宽度、增加限定编织物的成股材料的数目、和/或增加PPI(即纬密)，表面覆盖度和单元大小的每个参数可以进一步得到增强。
通过各种参数包括，例如，股数(例如，条带)、每根条带/股宽度、编织PPI、和/或成形装置直径(例如，轴直径)，仅举几例，所描述的编织或网格样式可以进一步被限定。基于网格参数，可以确定腿长(leg length)和条带夹角(ribbon angle)。腿长可以限定编织元件的一个方位的长度。例如，如果编织元件是如图17所示的菱形，菱形编织元件的一边的长度是“腿长”。条带夹角可以限定由编织元件的两交叉方位形成的夹角。在图17所示的例子中，条带夹角是在菱形编织元件的两邻边之间形成的夹角。在网格样式中编织元件的径向间距可以限定编织元件在径向的宽度。图18说明了编织元件的径向间距，腿长和条带夹角的一个例子。
网格的径向间距可通过下面所列的方程式1确定：
方程式(1)：径向间距＝(π)*(成形装置的直径)/(条带数/2)
基于径向间距或血管直径，编织元件可以适于血管。网格的径向间距可以根据血管直径进行调整。例如，如果血管直径小，径向间距可以调整到更小的尺寸而可以保持编织元件的腿长。也是在这个例子中，条带夹角也可以调整以获得调整的径向间距。调整条带夹角也可以改变编织元件在PPI方向上的间距。
图19说明了确定闭塞装置的网格结构的径向间距和条带夹角的一个例子。在这个例子中，网格或编织物含有16根交织条带，每根条带0.004英寸宽，编织在成形装置比如直径为4.25毫米和65PPI的轴上。因此，在这个例子中，编织元件的数目是16，条带宽度是0.004英寸，在PPI方向的间距是1/65＝0.01538英寸，成形装置的直径(例如，轴的直径)是4.25毫米。因此，径向间距可以这样计算：径向间距＝(π)*(成形装置的直径)/(条带数/2)＝(3.14)*(0.425/2.54)/(16/2)＝0.0657英寸。图19说明了具有径向间距0.0657英寸的编织元件的一个例子。此外，这个例子的腿长是0.0337英寸，条带夹角是153.65度，基于条带夹角和腿长，编织元件在PPI方向的间距是0.0154英寸。
图20说明了图19的编织元件适于合适的血管直径后的例子。在这个例子中，径向间距调整至更小的长度以适应较小的血管直径。该腿长保持在0.0337英寸不变，因此条带夹角根据径向间距的改变而改变。在这个例子中，径向间距调整为0.06184英寸，条带夹角调整至132.79度。并且，编织元件在PPI方向的间距也发生改变。在这个例子中，编织元件在PPI方向的间距从0.0154英寸增加至0.0270英寸。
表1说明了具有不同PPI、条带宽度(RW)或条带数目的网格或编织样式的其它例子。此外，表1中每个编织模式可以在血管内产生相同百分数覆盖度的样式。
表1
  条带数   16   32   64
  编织物直径(mm)   4.25   4.25   4.25
  编织物直径(in)   0.16732   0.16732   0.16732
  PPI   65.00   130.00   260.00
  条带宽度(mils)   4.0000   2.0000   1.0000
  节点间距(ppi)   0.01538   0.00769   0.00385
  节点间距(径向)   0.06571   0.03285   0.01643
  条带角度(ppi)   153.65   153.65   153.62
  腿长(in)   0.03374   0.01687   0.00844
  血管直径(mm)   4   4   4
  血管内装置节点间距   0.06184   0.03092   0.01546
  血管内装置条带夹角(ppi)   132.79   132.79   132.70
  血管内装置节点间距(ppi)   0.02702   0.01351   0.00677
  血管内装置PPI   37.01   74.04   147.72
  血管内装置编织闭合面积(in2)   0.00024814   0.00006203   0.00001551
  血管内装置编织开放面积(in2)   0.00058741   0.00014680   0.00003681
  血管内装置覆盖度   29.7％   29.7％   29.64％
  血管内装置总面积(in2)   0.00083555   0.00020883   0.00005232
  血管内装置单元大小(mm)   1.317   0.658   0.329
闭塞装置可以放入一个保护线圈以加强闭塞装置在血管内的安放。并且，闭塞装置可以被置于传递装置如导管中用于血管内的安放。基于容纳闭塞装置的保护线圈、传递装置或导管的尺寸，闭塞装置可以以某一大小或尺寸进行制造。例如，可以确定适于相应的保护线圈、传递装置或导管的闭塞装置的网格结构的股数或条带数以便闭塞装置在设置在血管中之前被有效储存或容纳。在一个例子中，闭塞装置的股带可以在一包括内层和外层的2层结构中重叠，外层接触保护线圈。
在一个例子中，容纳闭塞装置的外壳如保护线圈、传递装置或导管可以具有恒定大小或直径，可以确定闭塞装置的规格参数去适于外壳。例如，基于外壳的期望的大小可以确定条带大小或宽度。通过这种方式，对于条带大小或数目可以不同的各种闭塞装置，外壳(例如，保护线圈、传递装置或导管)的大小(或直径)可以不变。
图21说明了保护线圈的横截面视图的一个例子。在这个例子中，确定用于保护线圈的闭塞装置的网格结构中的股数或条带数。显示在图21中的保护线圈具有一带直径的圆形横截面。预定厚度或大小的股或条带是这样置于保护线圈内的以便股/条带的外表面接触保护线圈的内表面。股/条带的内表面在保护线圈内造成一凹面。第二股/条带是这样置于保护线圈内的以便第二股/条带的外表面接触内圆周，与先前放置在保护线圈内的股/条带的凹面相接触。确定来自圆形保护线圈中心点的从第二股/条带的一边至第二股/条带的相对边的夹角(即“弧角”)。基于这些尺寸，具有预定大小或厚度的股数或条带数可以如下确定：(弧角)*(条带数/2)≤360度(即，条带数≤720度/角)。
在图21说明的例子中，闭塞装置通过使用0.001X0.004英寸的条带构建。在保护线圈中心的条带元件的弧角，在从保护线圈中心点至内层条带的一边所画的第一线条和从保护线圈中心点至内层条带的相对边所画的第二线条之间，是34.14度。因此，计算出来的条带数目小于或等于720度/34.14度＝20条带。
表2说明了在保护线圈内装载闭塞装置的网格结构的不同设计的其它例子。
表2
  条带数   16   32   64
  保护线圈ID(in)   0.017   0.017   0.017
  条带宽度(in)   0.004   0.002   0.001
  条带厚度(in)   0.001   0.001   0.001
  内圆角   36.98   17.83   8.84
  内圆的最大条带数   9.73   20.19   40.72
  内圆的条带数   8   16   32
图22说明了确定用于保护线圈或传递装置中的闭塞装置的条带尺寸的另一个例子。在这个例子中，具有基于条带厚度的网格或编织结构的闭塞装置。图22表明，保护线圈或传递装置2301的直径是0.0170英寸。第一条带2302是安装在保护线圈或传递装置2301的外表面内。第二条带2303是与保护线圈或传递装置2301的内圆周接触放置，其中内圆周是与第一条带2303的内表面相切的圆周。第二条带2303是这样放置在内圆周内的以便第二条带2303的侧端是与保护线圈或传递装置2301的内圆周相接触的。如图22中所显示的，计算出了从保护线圈或传递装置2301的中心点延伸至第二条带2303的一侧端的第一线条和从保护线圈或传递装置2301的中心点延伸至第二条带2303的另一侧端的第二线条之间的弧角。
在这个例子中，基于所形成的计算出的弧角，确定了第一和第二条带2302，2303的最大尺寸。例如，为了在保护线圈或传递装置2301的内圆周内允许8条条带，弧角可以计算为(360度)/8＝45度，如图22所示。基于45度角，可以确定最大条带宽度为0.00476英寸以允许8条厚度为0.001英寸的条带适于在保护线圈或传递装置2301的内圆周内。
在另一个例子中，使用更窄的条带宽度去补偿材料耐受变化和曲率。基于申请人的广泛研究和实验，发现用于条带宽度的约20％的耐受范围能够补偿这样的材料耐受变化。图23说明了用于闭塞装置的条带宽度的20％耐受范围或缓冲的一个例子。
在这个例子中，在闭塞装置中20％的额外条带是期望的(即1.20*8＝9.6条带)。基于9.6条条带的期望数目，通过如上所述计算角度，可以确定条带的最大宽度。具体来说，弧角可以计算为(360度)/9.6＝37.7度。基于该计算，可以确定条带的最大宽度为0.00405英寸，如图23所示。因此，在这个例子中，应用了20％的缓冲以允许在保护线圈或传递装置中的9.6条条带的最大宽度为0.00405英寸。
表3提供了对于各种条带厚度的条带宽度的其它例子。在表3提供的例子中，条带厚度的范围从0.0007英寸至0.0015英寸。
表3
  条带厚度(in)   计算的最大宽度(in)   20％缓冲宽度(in)
  0.0005   0.00543   00.00463
  0.0006   0.00530   0.00452
  0.0007   0.00516   0.00440
  0.0008   0.00503   0.00428
  0.0009   0.00490   0.00417
  0.0010   0.00476   0.00405
  0.0011   0.00463   0.00393
  0.0012   0.00450   0.00382
  0.0013   0.00436   0.00370
  0.0014   0.00422   0.00358
  0.0015   0.00409   0.00346
在另一例子中，描述了含有32条条带的闭塞装置。图24说明了基于能够设置在保护线圈或传递装置2501内的条带数目来确定32-条带闭塞装置的条带宽度的例子。在这个例子中，保护线圈或传递装置2501具有0.017英寸的直径，能够设置在保护线圈或传递装置2501的内圆周内的最大的条带宽度提供了(360度)/(32/2)＝22.5度的弧角，如图24所示。因此，为沿保护线圈或传递装置2501的内圆周设置16条条带，确定条带的宽度为0.00266英寸，具有0.00080英寸厚，如图24所示。同样的，20％的缓冲可用于条带宽度去提供给更窄的条带宽度以补偿材料耐受变化。在这个例子中，基于(360度)/19.2＝18.75度的新的弧角要求，可以确定调整的条带宽度。表4提供了用于32-条带闭塞装置的最大条带宽度。
表4
  条带厚度(in)   计算出的最大宽度(in)   20％缓冲宽度(in)
  0.0005   0.00288   0.00242
  0.0006   0.00281   0.00235
  0.0007   0.00273   0.00299
  0.0008   0.00266   0.00223
  0.0009   0.00258   0.00216
  0.0010   0.00251   0.00210
可选择的，在闭塞装置中可以包含更大数目的条带。例如，股或条带可以增加到大于32，如40、44、48、50、56、60、64、70、76、80、90、100、或更多。对于任何期望的条带数目，可以如所述那样基于计算出的角度或条带厚度确定条带宽度。此外，缓冲可以如所述那样用于条带宽度。
在另一例子中，可以使用相对于血管过大的闭塞装置。例如，相对于血管管腔的尺寸，更大的闭塞装置可能导致闭塞装置在血管管腔中的锚固加强。图25说明了血管内的闭塞装置的PPI(“血管内PPI”，“in-vessel PPI”)和自由站立状态的闭塞装置的PPI(编织的PPI，“braided PPI”)之间的关系。图25中的曲线图证明对于每种设计，随着自由站立状态的闭塞装置的纬密增加，在血管内的闭塞装置的PPI接近最大值。例如，对于4毫米血管设计，随着自由站立的闭塞装置的PPI增加，在血管内的闭塞装置的PPI也增加直至血管内PPI达到约45。当血管内的PPI达到约45，进一步增加编织的PPI仅导致血管内PPI进一步微小的增加。在图25中还说明，不同血管设计(例如，3毫米血管设计或5毫米血管设计)导致类似的行为，其中对于高编织纬密，血管内PPI接近最大值。
相似的，图28说明了血管内PPI作为32条带闭塞装置的编织的PPI的函数。在图28所示的例子中，随着自由站立状态的闭塞装置的PPI(编织的PPI)，血管内的闭塞装置的PPI(血管内PPI)接近最大值。图28也说明了可选择的血管设计。在图28的血管设计的例子中可以看出，对于每一个血管设计，随着编织的PPI增加，血管内PPI逐渐接近最大值。
相似的，闭塞装置的覆盖度可以基于条带宽度或编织的PPI。图26说明了一个例子，其中条带是0.00467英寸宽和0.001英寸，是适于保护线圈的最大的条带大小。如图26所示，覆盖度接近约65～100PPI范围的最大值。在这个例子中，对于0.001″X0.00467″条带，覆盖度的百分数逐渐接近约40％，对于0.001″X0.004″条带，约34％。
图29说明了对于32条带闭塞装置，覆盖百分数作为编织的PPI的函数。如图29证明的，随着编织的PPI增加，覆盖％接近最大值。例如，对于含有0.0008X0.00266英寸的条带的闭塞装置，随着编织的PPI增加到约150以上，覆盖％接近最大值约43％。同样，对于含有0.0008X0.0020英寸的条带的闭塞装置，随着编织的PPI增加到约150以上，覆盖％接近最大值约35％。
图27是表示闭塞装置的编织元件的开口大小是网格结构的PPI的函数的曲线图。随着PPI增加，液体(如血液)流过的开口大小或空间减小。随着网格结构的PPI达到约100，当位于血管内时编织元件的开口大小渐近最小值。在图27所示的例子中，对于0.001X0.004英寸的条带大小，血管内的闭塞装置的网格结构的编织元件的开口大小接近1280微米或以下。相似的，对于0.001X0.00467英寸的条带大小，血管内的闭塞装置的网格结构的编织元件的开口大小接近1220。
图30说明了对于32条带闭塞装置，闭塞装置的编织元件的开口大小作为网格结构的编织的PPI的函数。如图30证明的，随着编织的PPI增加，编织元件的孔眼大小接近最小值。例如，对于含有0.0008X0.00266英寸的条带的闭塞装置，随着编织的PPI增加至约150以上，编织元件的开口大小接近最小值约小于600微米。同样的，对于含有0.0008X0.0020英寸的条带的闭塞装置，随着编织的PPI增加至约150以上，编织元件的开口大小接近最小值约640微米。
闭塞装置30是径向可压缩的和径向可展开的而无需额外的径向展开力，如充气球囊。闭塞装置30是通过反向缠绕两股带31和32来构建的。可选择的，可以在不同方向缠绕2股以上。举例来说，可以在不同的方向缠绕8、10、12、14、22、28、30、32、36、40、44、48、52、58、64、70、86、90、110、116、120、128、136、150、或更多股。在一具体实施例中，股带31和32是矩形条带(见图4C)。条带可以由已知的柔软材料加工成形，包括形状记忆材料，如镍、铂和不锈钢。
作为编织材料用于股带31和32的条带可以包括矩形横截面35(图4C)。如图4C和7所示，与在表面36和37之间延伸的壁38(厚度)相比，接触血管内表面的表面36具有较长的尺寸(宽度)。当与具有圆形的(圆的)横截面的金属丝相比，对于同样的壁厚，带有矩形横截面的条带具有更高的回复(展开)力。此外，扁平条带允许闭塞装置20更紧凑的压缩，且当放置时，对血管壁造成较小的损伤，因为它将径向展开力分布在更大的表面积上。同样的，对于给定的网格密度，扁平条带形成更加柔软的装置，因为对于给定的厚度，与圆形金属丝装置相比，它们的表面积(宽度)更大。
虽然图示的实施例公开了具有矩形横截面的条带，其中长度大于它的厚度，用于所公开的闭塞装置的另一替代实施例的条带可以包括正方形横截面。在另一替代实施例中，条带的第一部分可以包括矩形横截面的第一形状，条带(图4B)的第二部分39可以包括圆形、椭圆形、卵形或矩形截面的其它形状。举例来说，条带的端部可以具有基本圆形或卵形横截面，条带的中部可以具有矩形横截面。
在上述可选的具体实施例中，闭塞装置30可以形成通过缠绕两股以上的条带来形成。在一具体实施例中，闭塞装置30可以包括多达16股条带。在另一具体实施例中，闭塞装置30可以包括，比如，多达32股条带，多达48股条带，多达60股条带，多达80股条带，多达100股条带，多达150股条带或大于150股条带。通过使用在制造径向展开支架中采用的标准技术，可以制造闭塞装置30，其带有大于条带厚度或金属丝直径的空隙34。条带可以具有不同的宽度。在这样一个具体实施例中，不同的条带可以有不同的宽度去提供结构支持给闭塞装置30和血管壁。根据披露的具体实施例，条带也可以由不同材料加工成形。例如，条带的一条或更多条可以由一种生物相容的金属材料如在此披露的那些材料加工成形，条带的一条或更多条可以由一种生物相容的聚合物加工成形。
图5显示位于微导管25内的压缩状态的血管内闭塞装置30。在一具体实施例中，闭塞装置30可以身体接触导管尖端。这可以通过将闭塞装置30限制在微导管的远端部分来实现。微导管25是用活塞50沿着导丝(未显示)缓慢前进的，当微导管25的尖端到达动脉瘤，闭塞装置从尖端释放。闭塞装置30展开至血管的尺寸，闭塞装置30的表面现在置于血管壁15上，如图6所示。用于传递和展开闭塞装置30的仪器和方法揭示在上面参考的与此有关尚待批准的申请中。
参见图7，闭塞装置30设置在带有动脉瘤10的脑血管13的管腔内。在其设置期间，闭塞装置30的近端43牢固地抵靠分叉15前的血管13的管腔壁，闭塞装置30的远端45牢固地抵靠动脉瘤10的颈部11那边的血管13的管腔壁。在闭塞装置30适当地位于血管13内的期望位置(例如，见图7)后，在动脉瘤10的管腔内的流动显著减少，而血管13内的轴向流动没有受到显著影响，部分由于壁38的极小的厚度。
流入动脉瘤10的流动将会被条带的网格密度和由此产生的表面覆盖度控制。具有较大网格密度的区域将会有减少的径向(横向)流动。相反，具有较小网格密度的区域将允许可观的径向流动通过闭塞装置30。如下面所讨论的，闭塞装置30可以具有带不同密度的纵向延伸(横向)区域。在这些区域的每一个中，它们周围的密度可以不变或变化。这提供了不同流量通过邻近的横向区域。通过放射学可以确定血管内具有较大密度区域的位置以便可以确定闭塞装置30与动脉瘤10和任何分支血管15、16的相对位置。闭塞装置30也可以包括不透射线标记(radiopaque makers)。
动脉瘤10内的血液流动的减少导致对管壁14的力的减少和相应的血管破裂危险的减少。当进入动脉瘤10的血液的力量和体积被闭塞装置减少，进入动脉瘤10的层流被停止，动脉瘤内的血液开始停滞不流动。血液的停滞，与通过动脉瘤10的管腔12的连续流动相反，在动脉瘤10中导致血栓。这也保护了动脉瘤免于破裂。此外，由于在分叉15的闭塞装置30部分的密度，闭塞装置30中的开口(间隙)34允许血液继续流至分叉15和分支血管16。如图8所示，如果分叉15是动脉瘤的下游，闭塞装置30的存在仍然使血液远离动脉瘤10并进入分叉15。
在这里描述的闭塞装置具有柔软性以符合血管的曲率。这是与冠状动脉支架使血管基本上符合它们的形状相反。符合血管形状的能力对于神经血管闭塞装置比对于冠状动脉支架更加重要，因为大脑中的血管更小和更弯曲。表5和表6说明要求的神经血管闭塞装置的这些特征。为了证明披露的闭塞装置表现出非常理想的弯曲特点，进行了下面的实验。如图9所示，由发明者制造的闭塞装置置于支持表面90上。闭塞装置30约0.5英寸不受支持。然后，测定的力施加于不受支持的末端直到闭塞装置从起点偏转90度。市售冠状动脉支架的类似长度受到同样的弯矩。结果显示在表5中。与减少的压缩力相似，本发明的闭塞装置需要低一个数量级的弯矩(0.005lb-in与冠状动脉支架的0.05lb-in相比)。
表5：弯曲闭塞装置的0.5″悬臂需要的弯曲力
  冠状动脉支架 市售支架   0.05lb-in
  神经血管闭塞装置(30)   0.005lb-in
与冠状动脉支架相比，根据本发明的闭塞装置还提供了增强的可压缩性(即，对一给定的力可以达到多少压缩或为达到期望压缩需要施加多少力)。与高度可压缩装置相比，不是高度可压缩的血管内装置将对血管壁施加更大的力。这在脑血管中具有重大的临床影响，因为具有低压缩性的血管内装置是有害的。
表6：压缩闭塞装置至原直径的50％需要的压缩力(见图10)
  冠状动脉支架 (市售)   0.2lb
  神经血管闭塞装置(30)   0.02lb
图11-13显示了闭塞装置60的一具体实施例，其中闭塞装置60的网格结构63沿闭塞装置60的长度上是不一致的。在闭塞装置60的中部65，其可能是置于动脉瘤颈部的部分，网格密度63a有意增加至一个显著高于闭塞装置60其它地方的网格密度的值。例如，如图11中所见，网格密度63A是显著高于邻近区域64的网格密度63。在一个极端，网格密度(由空隙提供的孔隙率)可以为零，即，闭塞装置60是完全不透水的。在另一实施例中，中部65的网格密度63A可以是约50％，而在闭塞装置的其它部分64的网格密度约25％。图12显示弯曲形状的这样的闭塞装置60，图13显示置于血管的管腔中的该闭塞装置60。图13也说明具有增加的网格密度63A的闭塞装置部分沿着动脉瘤10的颈部放置。正如任何披露的闭塞装置，闭塞装置60的至少一部分的网格密度可以在约20％和约80％之间。这些具体实施例的网格密度可以在约25％和约50％之间。
闭塞装置300的另一具体实施例显示在图14和15中。在此具体实施例中，闭塞装置300置于具有动脉瘤的血管的管腔中。闭塞装置300包括朝向动脉瘤管腔的表面310。与直径上相对的表面320相比，该表面310具有显著较高的网格密度(较小的和/或较少的空隙)。由于表面310的较高的网格密度，更少的血液流入动脉瘤的管腔。然而，对血液流入分支血管没有负面影响，因为朝向分支血管的表面320的网格密度没有减少。
在此处披露的任何闭塞装置可以和第二闭塞装置一起使用以构造如图16所示的分叉闭塞装置400。该装置可以在体内构建。在形成闭塞装置400过程中，具有低密度的第一闭塞装置410的一部分可以和也具有低密度的第二闭塞装置420的一部分结合。闭塞装置410和420可以是这里讨论的那些装置的任何一个。在这两闭塞装置410和420的这些部分以交织方式结合在一起从而形成交织区域425后，剩余部分414和424可以分叉开朝向不同方向，从而沿分叉的两支线延伸。交织区域425外的区域可以有更大的网格密度用于治疗动脉瘤或更小的网格密度以允许流向分支血管15和16。
每个披露的闭塞装置的网格密度可以是其闭塞装置的表面积的约20％～约80％。在一具体实施例中，网格密度可以是其闭塞装置的表面积的约20％至约50％。在另一具体实施例中，网格密度可以是其闭塞装置的表面积的约20％至约305。
一典型的闭塞装置具有16股编织物，带有0.005英寸宽的条带，30纬密(picks per inch，PPI)(每英寸连接点/交叉数目)，和0.09英寸外径，具有大约30％的网格密度(被条带覆盖的表面)。在此披露的具体实施例中，条带可以是约0.001英寸厚、宽度在约0.002英寸到约0.005英寸之间。在一具体实施例中，条带具有约0.004英寸厚度。对于16股约0.001英寸厚及约0.004英寸宽的条带，对应50PPI、40PPI和30PPI，覆盖度分别为约40％、32％和24％表面覆盖度。对于16股约0.001英寸厚及约0.005英寸宽的条带，对应50PPI、40PPI和30PPI，覆盖度分别为约50％、40％和30％表面覆盖度。
在选择条带大小时，必须考虑到，当条带捆绑起来时，它们将横穿通过微导管。例如，16股0.006英寸宽的条带可能不能通过内径为0.027英寸或更低的微导管。然而，随着条带的宽度变得越来越小，回复力可能会成比例降低。
然而可以使用其它股带的几何形状，这些其它几何形状，如圆形，由于它们的厚度尺寸，将限制该装置。例如，直径0.002英寸的圆金属丝将在血管内占据高达0.008英寸横截面空间。这空间可以影响和破坏血流通过血管。直径的改变可以破坏血管内的流动。
虽然详细描述包含了许多细节，这些不应被理解为限制本发明的范围，而只是作为说明本发明的不同的例子和方面。应该认识到本发明的范围包括其它没有在上面详细讨论的具体实施例。对本领域技术人员来说明显的其它各种修改、改变和变化可以在此处披露的本发明的方法和装置的设置、操作和细节中作出而不背离在所附的权利要求中限定的本发明的精神和范围。因此，本发明的范围应该通过附加的权利要求和它们的合法的等同物来确定。更进一步地，不管元件、组件或方法步骤是否在权利要求中明确列举，元件、组件或方法步骤均不是用来献给公众的。
在权利要求中，以单数提到一个元件并不意味着“一个或只有一个”，除非明确指出，而是正相反是指“一个或以上”。此外，对于装置或方法，没有必要为了被权利要求覆盖而去解决被本发明的不同具体实施例解决的每个问题。

Claims (6)

1.一种用于在环形的线圈内制造用于放置于血管内栓塞动脉瘤的装置的方法，该装置包括多根交织条带，该方法包括步骤：
与线圈的内表面接触放置第一条带，第一条带的底表面与线圈的内表面相切；
与线圈的内圆周接触放置第二条带，并且基于第二条带限定弧角；
基于所述弧角为装置提供多根条带；以及
交织所述多根条带从而形成该装置；
其中所述弧角：（a）由位于所述线圈的周面处的第二条带的宽度在所述线圈的中心点处形成的角限定；以及（b）等于或小于720度/条带数量。
2.根据权利要求1所述的方法，其特征在于，多根条带大于或等于8根。
3.根据权利要求2所述的方法，其特征在于，多根条带大于或等于32根。
4.根据权利要求3所述的方法，其特征在于，多根条带是48根。
5.根据权利要求3所述的方法，其特征在于，多根条带是60根。
6.根据权利要求3所述的方法，其特征在于，多根条带大于60根。
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US8382825B2 (en) 2013-02-26
EP2026716A4 (en) 2012-08-08
CN103169522A (zh) 2013-06-26
CN101472536A (zh) 2009-07-01
US9393021B2 (en) 2016-07-19
US20060206200A1 (en) 2006-09-14
AU2007268144A1 (en) 2007-12-06
CA2652022C (en) 2015-12-01
WO2007139699A2 (en) 2007-12-06
US20140074149A1 (en) 2014-03-13
WO2007139699A3 (en) 2008-09-25
US20110166592A1 (en) 2011-07-07
JP2013081868A (ja) 2013-05-09
CA2652022A1 (en) 2007-12-06
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AU2007268144B2 (en) 2011-10-13
EP2026716A2 (en) 2009-02-25

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