CN101472537A - 柔软的血管闭塞装置 - Google Patents
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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
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日提交的序列号为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 ofCerebral 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。
目前，存在许多不同的支架结构和支架放置方法。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。所有支架需要具有径向刚度以保持管腔的开放，同时具有纵向柔软性以帮助在血管系统的弯曲路径中穿行。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稍微过度展开安装球囊的支架使支架嵌入血管壁，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，即使在放置调节器之后。
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。
在另一方面，该装置可以包括闭塞装置，其一部分具有第一网格密度和第二部分具有第二网格密度，第一和第二网格密度不同。在另一例子中，第一网格密度和/或第二网格密度可以调节。例如，一个输入动作可以决定第一和/或第二网格密度。
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说明用于在闭塞装置中调节网格密度的网格密度调节工具的一个例子。
图18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放置的闭塞装置的一个例子。
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”，美国序列号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。
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。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。
在上述可选择的具体实施例中，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的柔软性为符合血管的曲率是必要的。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(0.0051b-in与冠状动脉支架的0.051b-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 | 0.051b-in |
| 神经血管闭塞装置(30) | 0.0051b-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 可市售 | 0.21b |
| 神经血管闭塞装置(30) | 0.021b |
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。
如在上面的例子中的详细描述，闭塞装置的不同部分可以具有不同的网格密度以便可以基于在闭塞装置内的位置控制流体或血液的流动。网格密度可以进一步被闭塞装置接收到的输入来控制。用于控制闭塞装置不同部分的网格密度的输入可以包括，例如，施加于闭塞装置的一个部分的压力或运动力。在这个例子中闭塞装置可以包括螺旋缠绕材料如在此所述的在网格结构中的股带或条带。螺旋缠绕的股带可以是相对彼此可移动的。例如，第一股带和第二股带可以是螺旋缠绕以形成包括交叉股带(第一股带和第二股带可以相互交叉)的在股带之间散布开口的网格结构。
在另一个例子中，如所述的，基于输入(例如，运动、压力或力量输入)，闭塞装置的由交叉股带形成的网格结构可以是可调节的。当闭塞装置接收到输入，股带可以相对彼此移动。例如，第一股带的一部分可以移动得更接近第二股带的对应部分，第一股带的第二部分也可以移动得更远离第二股带的对应第一部分。因此，在这个例子中，形成闭塞装置网格结构的螺旋缠绕材料的第一股带和第二股带之间的间距可以变化以创建不同的网格密度。当闭塞装置的一个部分的股带移动得相互更接近而闭塞装置的另一部分的股带移动得相互更远，闭塞装置的不同部分可以具有不同的网格密度。
同样，股带的相对移动可以基于闭塞装置接收到的输入来控制。如上所述，输入可以包括用于移动或调节闭塞装置的任何类型的输入，例如，压力、力量、运动、旋转、或其他相似的输入。
闭塞装置可以放置在血管中，闭塞装置的某一部分可以含有高网格密度而在闭塞装置的不同部分保持较低的网格密度。接收到的输入可以控制闭塞装置的放置和/或网格密度以在闭塞装置的选定部分获得期望的网格密度。这样，闭塞装置接收到的输入可以导致闭塞装置的第一部分具有第一网格密度及闭塞装置的第二部分具有第二网格密度，其中第一网格密度和第二网格密度不同。
在一个例子中，使用者可以将闭塞装置插入血管中，并可以施加压力在闭塞装置上以导致闭塞装置的网格密度的调节。在另一个例子中，运动力可以施加于闭塞装置从而使形成网格结构的闭塞装置的股带可以在闭塞装置的至少一个部分中相对彼此移动。股带也可以在闭塞装置的不同部分重新进行不同布置从而使网格密度可以从闭塞装置的一个部分至闭塞装置的另一个部分呈现不同。
例如，闭塞装置可以包括网格密度调节工具以便由网格密度调节工具施加在闭塞装置的一个部分的压力可以导致网格密度调节工具作用的闭塞装置的该部分的网格密度获得期望的网格密度。图17说明了含有用于调整闭塞装置1701的任何期望部分的网格密度的网格密度调节工具1702的闭塞装置1701的一个例子。使用者可以在网格密度调节工具1702的近端施加力量，其可以使网格密度调节工具的远端调节网格材料用于改变网格密度。另外，网格密度调节工具1702的移动可以使使用者调整闭塞装置任何期望部分的网格密度。
可以通过输送装置进一步管理和放置闭塞装置进血管中。例如，输送装置可以包括一管状结构如导管，通过它闭塞装置可以放进血管中。输送装置可以进一步包括可以用于调整闭塞装置网格密度的网格密度调节工具1702。如果需要，网格密度调节工具1702可以进一步仅在闭塞装置的一个部分调整网格密度而不影响闭塞装置的其他部分。可选择的，网格密度调节工具1702可以用于增加闭塞装置的一个部分的网格密度而降低闭塞装置的另一个部分的网格密度。网格密度调节工具1702可以由经由输送装置施加的压力或运动所控制。
在一个例子中，网格密度调节工具1702可以连接金属丝至输送装置的近端。使用者可以施加力量至位于闭塞装置近端的金属丝的近端。施加的力量可以是例如压力或运动力，可以导致网格密度调节工具1702的相应移动。网格密度调节工具1702的移动可以进一步接触闭塞装置的股带以移动股带。闭塞装置的股带的移动可以导致闭塞装置的至少一个部分的网格密度的改变。因此，使用者输入可以控制网格密度调节工具1702去使闭塞装置的选定部分的网格密度变化。
在另一个例子中，闭塞装置的网格密度可以基于闭塞装置在血管中的移动来调整。例如，闭塞装置可以在血管中放置和移动。随着闭塞装置在血管中的移动，闭塞装置的选定部分的网格密度可以相应调整。闭塞装置的一个部分的网格密度可以增加而闭塞装置的另一个部分的网格密度可以增加、减少或保持不变。在一个例子中，闭塞装置接触血管的管壁，力量施加在闭塞装置的近端。例如，使用者可以施加力量至闭塞装置的近端。该力量，其可以是例如压力或运动力，可以施加在输送装置的近端，通过它闭塞装置可以放置在血管中并可以在血管中调节。施加的力量导致闭塞装置的股带或条带调整从而使闭塞装置的网格密度基于闭塞装置的部分而呈现不同。
作为一个例子，闭塞装置含有形成具有网格密度的网格结构的相互交织条带。闭塞装置导入至动脉瘤的血管中的一个位置。闭塞装置进一步应用在或围绕动脉瘤的血管部分，如图7所示。闭塞装置的外侧可以接触包围动脉瘤区域的血管的至少一部分，然而，位于动脉瘤位置的闭塞装置的外侧不接触血管的管壁。这可能是因为动脉瘤是这样坐落的使得动脉瘤的壁从包围的血管的管壁朝外突出从而闭塞装置的外侧或表面不直接接触动脉瘤的壁的内表面。
压力可以施加于，例如，闭塞装置的近端。在这个例子中，闭塞装置的网格结构是自由调节的以便压力可以导致闭塞装置的网格结构的朝远处方向的移动。作用在闭塞装置上的来自于与闭塞装置的外侧或表面接触的血管管壁的内表面的摩擦力可以阻碍在与血管管壁接触的闭塞装置的区域内的网格结构的移动。但是，通过在闭塞装置的近端持续施加压力实现血管内的闭塞装置的逐渐移动(在这个例子中)。
在这个例子中覆盖动脉瘤颈部的闭塞装置的那部分不接触血管的管壁。因为闭塞装置的这部分与直接接触血管内壁的闭塞装置的那部分相比受到较少的摩擦力，随着施加的力量导致接近动脉瘤的闭塞装置的那部分移向远处从而导致施加在覆盖动脉瘤的闭塞装置的那部分上的力量的增加，覆盖动脉瘤的闭塞装置的网格结构可以改变。同样，覆盖远离动脉瘤的血管管壁的闭塞装置的那部分可能受到比施加到覆盖动脉瘤的闭塞装置的那部分的摩擦力更大的摩擦力。因此，在这个例子中，覆盖动脉瘤的闭塞装置的网格密度增加了。与此同时，闭塞装置的那部分的网格密度要么没有增加要么增加程度小于覆盖动脉瘤的闭塞装置的那部分。
在另一个例子中，动脉瘤可以位于血管的分支血管，如图18所示。闭塞装置是这样放置以致闭塞装置的第一部分1801可以邻近血管分支和血管瘤。闭塞装置的第二部分1802可以覆盖血管分支1808，闭塞装置的第三部分可以覆盖远离血管分支1808的血管的一部分并邻近第一动脉瘤1809，闭塞装置的第四部分可以覆盖第一动脉瘤1809，闭塞装置的第五部分可以覆盖远离第一动脉瘤1809的血管部分并邻近第二动脉瘤1810。闭塞装置的第六部分可以覆盖第二动脉瘤1810。血流至动脉瘤的堵塞是期望的，然而，血液至分支血管的堵塞不是期望的。
在这个例子中，使用者可以施加压力或力量至闭塞装置的近端以使闭塞装置的一部分在血管内朝向远处方向前进。闭塞装置的第一部分1801(接近血管分支1808和动脉瘤1809和1810)可以传送该力量至闭塞装置的更远部分，包括跨越血管分支1808的闭塞装置的第二部分1802。在闭塞装置第二部分1802的阻碍闭塞装置前进的摩擦力是小的，因为闭塞装置的第二部分1802不直接接触血管管壁。相反，闭塞装置的第二部分1802覆盖在血管分支1808上，如图18所示。因此，随着闭塞装置的第一部分1801转移该力量至闭塞装置的第二部分1802，闭塞装置第二部分1802的网格密度增加。施加在闭塞装置上的负压力也可以导致闭塞装置第二部分1802的网格密度减小，从而允许血液流动到血管分支1808中。
闭塞装置的第二部分1802也转移该力量至覆盖远离血管分支1808的血管部分的闭塞装置的第三部分1803。然而，作用在闭塞装置第三部分1803的摩擦力高于作用在第二部分1802的那些摩擦力，因为闭塞装置的第三部分1803接触血管的管壁。因此，闭塞装置在第三部分1803的网格密度开始就小于闭塞装置在第二部分1802的网格密度。
施加在闭塞装置第三部分1803(覆盖和接触远离血管分支1808和第一动脉瘤1809的血管部分)的力量转移至闭塞装置的第四部分1804，这是覆盖第一动脉瘤1809的闭塞装置的部分。作用在闭塞装置第四部分1804的摩擦力小于作用在闭塞装置第三部分1803的摩擦力，因为闭塞装置的第四部分1804不直接接触血管的内壁。因此，施加在闭塞装置的第四部分1804的压力使闭塞装置的第四部分1804的网格密度增加。
同样，施加在闭塞装置第四部分1804的力量可以转移至闭塞装置的第五部分1805，其接触第一动脉瘤1809和第二动脉瘤1810之间的血管部分。作用在闭塞装置第五部分1805的摩擦力大于作用在闭塞装置第四部分1804的摩擦力，因为闭塞装置的第五部分1805的至少一部分接触血管的内壁。但是，闭塞装置的第四部分1804覆盖第一动脉瘤1809，并不接触血管管壁。因此，在这个例子中，施加在闭塞装置的多个部分的摩擦力的不同导致在闭塞装置的不同部分的网格密度的受控制的变化。
在图18中也说明了覆盖第二动脉瘤1810的闭塞装置的第六部分1806。作用在闭塞装置第六部分1806的摩擦力小于作用在闭塞装置第五部分1805的摩擦力，因为闭塞装置的第六部分1806不直接接触血管的内壁。于是，从闭塞装置的第五部分1805转移至闭塞装置第六部分1806的力量可以导致第六部分1806的网格密度增加。因此，通过在闭塞装置施加压力或运动力，可以增加闭塞装置第四部分和第六部分的网格密度。同样，闭塞装置收回例如拉近闭塞装置的近端可以使闭塞装置的第二部分的网格密度减小。这可以导致增加的血液和/或流体流至血管分支1808而阻碍血液和/或流体流至第一或第二动脉瘤(1809，1810)。
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。
在另一个例子中，闭塞装置的网格密度可以通过使用者输入如使用者输入运动来调节或改变。输入运动可以是在纵向的方向。例如，输入力量或压力可以朝沿闭塞装置纵轴的方向被闭塞装置的一部分接收。在力量、压力或接收输入力量的闭塞装置的股带的移动施加之前，闭塞装置的该部分可以具有网格密度。闭塞装置该部分的网格密度可以基于接收到的输入而改变。例如，闭塞装置的股带可以在闭塞装置中沿纵向移动。同样，闭塞装置股带的纵向移动可以发生在闭塞装置的一部分或可以发生在整个闭塞装置。在闭塞装置的一部分的闭塞装置的股带的纵向移动的例子中，闭塞装置该部分的股带可以基于接收到的输入来移动，以便接收到输入的闭塞装置的该部分的闭塞装置的网格密度可以增加。可选择的，响应输入力量、压力或运动，闭塞装置的一部分的网格也可以减少。同样，基于输入力量、压力或运动，闭塞装置第一部分的网格密度可以增加而闭塞装置第二部分的网格密度可以减小或保持不变。因此，基于闭塞装置接收到的输入，闭塞装置的不同部分可以具有不同的移动，以便闭塞装置的一个部分可以在网格密度上增加或减小而闭塞装置的任何其它部分可以在网格密度上减小或增加。可选择的，闭塞装置的任何一个部分的网格密度可以保持不变。
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 (20)
1.一种用于放置在血管内栓塞动脉瘤的管状装置，该装置包括在网格结构中的多根螺旋缠绕材料股带，其中该装置的网格结构具有在第一部分具有第一网格密度和在第二部分具有第二网格密度之一，第一网格密度和第二网格密度不同并都基于输入运动。
2.根据权利要求1所述的装置，其特征在于，第一网格密度大于第二网格密度，其中通过第一网格密度的网格结构的血液流动低于通过第二网格密度的网格结构的血液流动。
3.根据权利要求1所述的装置，其特征在于，网格结构的第一部分具有第一网格密度，网格结构的第二部分具有第二网格密度。
4.根据权利要求3所述的装置，其特征在于，网格结构的第一部分具有响应使用者输入的第一网格密度，网格结构的第二部分具有响应使用者输入的第二网格密度。
5.根据权利要求3所述的装置，其特征在于，第一网格密度大于第二网格密度，其中网格结构的第一部分覆盖动脉瘤。
6.根据权利要求5所述的装置，其特征在于，网格结构的第二部分与动脉瘤分开。
7.根据权利要求6所述的装置，其特征在于，网格结构的第二部分覆盖血管管腔。
8.根据权利要求1所述的装置，其特征在于，输入运动包括相对于装置在纵向方向的运动。
9.根据权利要求1所述的装置，其特征在于，螺旋缠绕材料包括条带。
10.根据权利要求9所述的装置，其特征在于，螺旋缠绕材料包括少于16股条带。
11.根据权利要求9所述的装置，其特征在于，每一条带具有不同的宽带。
12.根据权利要求9所述的装置，其特征在于，该装置是径向可压缩的。
13.根据权利要求9所述的装置，其特征在于，输入运动只改变闭塞装置第一部分的网格密度。
14.根据权利要求1所述的装置，其特征在于，进一步包括具有不同密度的纵向延伸区域。
15.根据权利要求14所述的装置，其特征在于，纵向延伸区域的圆周密度基于不同密度的区域变化。
16.根据权利要求1所述的装置，其特征在于，螺旋缠绕材料包括多根编织条带，每一条带包括内表面和用于邻近置于血管内壁的外表面，外表面形成闭塞装置第一和第二末端之间的闭塞装置的外圆周的一部分，多个开口延伸在内和外表面之间，该装置的外表面包括该装置的总圆周面积的约20％～约50％。
17.根据权利要求1所述的装置，其特征在于，第一网格密度的网格结构限制朝与该装置的长度成一角度的方向流经那里的流体流动，第二网格密度的网格结构相对于第一网格密度的网格结构允许更大的流经那里的流体流动。
18.根据权利要求1所述的装置，其特征在于，使用者输入包括在该装置的一个部分的施加力量，该施加力量在装置第一部分导致第一网格密度以及在装置第二部分导致第二网格密度。
19.根据权利要求18所述的装置，其特征在于，施加力量包括旋转力。
20.根据权利要求1所述的装置，其特征在于，进一步包括基于第二使用者输入改变该装置的第一网格密度和第二网格密度的至少一个。
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Also Published As
| Publication number | Publication date |
|---|---|
| CA2652176C (en) | 2013-04-02 |
| US20060206201A1 (en) | 2006-09-14 |
| EP2026714A2 (en) | 2009-02-25 |
| AU2007268135A1 (en) | 2007-12-06 |
| WO2007139689A2 (en) | 2007-12-06 |
| US8617234B2 (en) | 2013-12-31 |
| CN101472537B (zh) | 2013-09-04 |
| CA2652176A1 (en) | 2007-12-06 |
| EP2026714A4 (en) | 2012-08-08 |
| AU2007268135B2 (en) | 2013-02-28 |
| WO2007139689A3 (en) | 2008-09-18 |
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