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CN101394808A - 一种医疗设备 - Google Patents

一种医疗设备 Download PDF

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Publication number
CN101394808A
CN101394808A CNA2004800431878A CN200480043187A CN101394808A CN 101394808 A CN101394808 A CN 101394808A CN A2004800431878 A CNA2004800431878 A CN A2004800431878A CN 200480043187 A CN200480043187 A CN 200480043187A CN 101394808 A CN101394808 A CN 101394808A
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CN
China
Prior art keywords
equipment
film
support
mechanical expansion
expansion
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CNA2004800431878A
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English (en)
Inventor
利昂·鲁达克夫
迈克尔·欧'康诺尔
蒂帕克·冈赫
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Merlin MD Pte Ltd
Original Assignee
Merlin MD Pte Ltd
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Filing date
Publication date
Application filed by Merlin MD Pte Ltd filed Critical Merlin MD Pte Ltd
Publication of CN101394808A publication Critical patent/CN101394808A/zh
Pending legal-status Critical Current

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    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
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    • A—HUMAN NECESSITIES
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    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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Abstract

本发明提供了一种医疗设备，用于插入到身体血管中，以治疗动脉瘤(201)，所述设备包含：可机械扩张的设备(202)，其能从第一个位置扩张到第二个位置，所述可机械扩张的设备(202)径向地向外扩张至第二个位置，使得所述可机械扩张的设备(202)的外表面与血管内表面贴合从而保持住通过所述血管的流体通路；以及膜(203)，其可响应于所述可机械扩张的设备(202)的扩张，从第一个位置扩张至第二个位置，所述的膜(203)扩张至第二个位置时能阻碍血液循环到动脉瘤(201)，膜(203)的至少一部分固定到可机械扩张的设备(202)，以在扩张至第二个位置时，保持膜(203)相对于可机械扩张的设备(202)的位置。

Description

一种医疗设备
技术领域
本发明涉及一种医疗设备，用于插入到身体血管中，以治疗动脉瘤。
发明背景
血管疾病包括导致出血的动脉瘤，导致血管闭塞的动脉硬化，血管畸形和肿瘤。脑中的血管闭塞或动脉瘤的破裂会导致中风。由颅内动脉提供营养支持的动脉瘤能在脑中生长，至其质量和大小能导致中风或中风征状的程度，这需要外科手术移除动脉瘤或需要其它治疗性干涉。
冠状动脉的闭塞，例如，是心脏病的常见诱因。有病的以及被阻塞的冠状动脉会限制心脏中的血流，导致组织缺血和坏死。虽然硬化性心血管疾病的确切病因还存疑问，但是对狭窄的冠状动脉的治疗更为确定。当在一条或多条动脉中存在数个疾病部分时，外科手术构建冠状动脉搭桥(CABG)通常是选用的方法。当然，传统的心内直视手术对经历此类治疗的的患者来说是非常具有侵入性的并且是创伤性的。因此，较少创伤的替代性方法是人们非常想要的。
一种替代方法是球囊血管成形术(balloon angioplasty)，该技术中，将折叠的球囊插入到使动脉闭塞或部分闭塞的狭窄中，使球囊膨胀以张开闭塞的动脉。另一种替代方法是斑块旋切术(anthrectomy)，该技术中，将闭塞的动脉粥样化部分从动脉的内表面切除。采用两种方法，都会有一定百分比的患者遭到再闭塞。
近来对于血管闭塞的优选疗法是在血管的闭塞区域植入可扩张的金属线框(包括支架(stent))，来保持血管的张开。通过运送装置(通常是导管(catheter))，将支架运送到血管系统中想要的位置。支架植入方法相对传统的血管外科手术的优点包括：避免了通过外科手术对缺陷血管暴露、去除、代替或者搭桥(包括心肺搭桥)、开胸和普通的麻醉的需要。
通过球囊血管成形术对动脉进行扩张之后，支架插入身体的血管、导管或管道(“脉管”)，例如冠状动脉中，并展开时，其充当假体，保持血管张开。支架通常具有末端开放的管状形式，具有相互连接的撑条(strut)作为其侧壁，使其能从第一外径(足够小到允许支架穿过血管，到达其将被展开的位点)扩张为第二外径(足够大，能贴合血管内层，以保留在该位置)。典型地，支架以未扩张的状态运送至体内想要的位置，然后再扩张。通过使用机械设备，例如球囊来使支架扩张，或者，支架自身扩张。
通常，用于成功的干涉性植入的合适支架应当具有如下特征：相对不致敏的反应、良好的辐射不能透过性、在磁共振成像上不失真、具有合适弹性的挠性从而能塑性变形、对血管反冲(recoil)的强大抵抗性、足够薄以使其对血流(或除心血管系统之外，血管中其它流体或物质)的妨碍最小化以及避免血管再闭塞的生物相容性。对构成支架的材料的选择以及对支架的设计在影响上述特征的方面具有重要作用。
此外，可植入的医疗设备已被用于运送药物或生物试剂，用于不同的生物学应用。典型地，药物或生物试剂被涂布于可植入的医疗设备的表面，或混合进涂布到可植入的医疗设备表面的聚合材料中。但是，所有现有的方法会遭遇下述一种或多种问题，包括不可控制的释放、药物形式受限以及体积庞大的外观。
因此，人们需要一种可植入的医疗设备，其能将药物或试剂有效运送至内部血管系统，尤其是颅内血管。
发明内容
在第一个优选的方面，本发明提供了一种医疗设备，用于插入到身体血管中，以治疗动脉瘤，所述设备包含：
可机械扩张的设备，其能从第一个位置扩张到第二个位置，所述可机械扩张的设备径向地向外扩张至第二个位置，使得所述可机械扩张的设备的外表面与血管内表面贴合从而保持住通过所述血管的流体通路；以及
膜，其可响应于所述可机械扩张的设备的扩张，从第一个位置扩张至第二个位置，所述的膜扩张至第二个位置时能阻碍血液循环到动脉瘤，膜的至少一部分固定到可机械扩张的设备，以在扩张至第二个位置时保持膜相对于可机械扩张的设备的位置。
可机械扩张的设备可以包含基本为管状的结构，其具有由多个相互连接的撑条确定出的外表面，所述撑条之间具有空隙空间。
膜可由生物相容的、弹性聚合物制成。
膜可以具有大约0.001至0.005”的厚度，具有大约20至100微米的孔径或洞径。
膜可由聚合材料或生物可降解的材料制成。
生物可降解的材料可以形成混合有药物或试剂的多个亚层。
膜可以进行各向同性扩张。膜可以从运送形式(当折叠于运送系统上时)扩张为展开形式。因此，膜(通过附着到支架的撑条上制造的)的最初尺寸可等同于1.5至2.5mm的直径。之后，在折叠(与可机械扩张的设备一起)到运送导管上时，膜可以经历收缩。具有膜的可机械扩张的设备可以具有等于0.5至0.9mm的直径。展开之后，膜可以达到高达2.5至4.5mm的直径。用于膜制造的合适材料可以是伸长率高达600至800％的弹性聚合物。例如，经过改性的聚氨酯或硅酮。
膜可以被放置于设备的外表面。
膜可以完全包围设备。
膜可以呈圆周形地环绕设备的一部分。
膜可以覆盖设备的一部分。
膜可以是无孔的且不能透过的，以防止血液循环到动脉瘤中。膜可以由固体聚合物制成。
膜可以是可透过的以及有孔的。膜可以具有洞或孔，使得向主要脑动脉的细微分支和穿孔(perforation)提供血液是允许的，而向动脉瘤提供血液是被阻止的。膜可以具有大小在20至100微米之间的孔。膜可以制造有大小在20至100微米之间的洞。洞可以通过激光钻孔来制造。孔或洞之间的距离可以小于100μm。
有利地，在具有细微分支(被称为穿孔)的脑动脉的某些部分，可透过的膜是理想的。针对动脉瘤放置膜的时候，不封闭住这些穿孔是重要的。这阻挡了到达其中由穿孔提供血液供应的脑部区域的通路。另一方面，可透过的膜阻碍了血液循环进动脉瘤。
膜可以包含固定到可机械扩张的设备的多个聚合物条带。这些条带可以小于0.075mm，相邻条带之间的距离小于100μm。
膜可以包含固定到可机械扩张的设备的网。网孔间隔小于100μm，网孔的宽度在0.025至0.050mm之间。
动脉瘤可以是常规大小的、巨大的或宽颈动脉瘤。
可机械扩张的设备可以是可自身扩张的或可通过球囊扩张的。
可机械扩张的设备可以是支架。
膜可被基本为管状的结构支持，其可以附着到至少一种撑条上。
膜可以是管状结构，其具有与支架的名义初始直径相似的直径；以及，其中，膜被放置到支架的外表面上，或通过浸渍涂布或喷雾或任何其它合适的制造方法引入到支架的撑条之间。在这种情况下，撑条可被用于制造膜的聚合物包住。
膜可以是放置到撑条外表面一部分上的管状结构的部分。
至少一种试剂可以是选自由固体药片、液体或粉末构成的组的任何一种形式。
可在可机械扩张的设备上提供至少一种不可透过辐射的标记，以提高插入过程中和插入后设备的可视性。至少一种不可透过辐射的标记可以由金或铂制成。可在可机械扩张的设备上提供中央的不可透过辐射的标记以及末端的不可透过辐射的标记。
在第二个方面，本发明提供了一种医疗设备，用于治疗至少两处身体血管之间的二叉或三叉动脉瘤，所述设备包含：
第一可机械扩张的设备，用于插入到第一血管中；
第二可机械扩张的设备，用于插入到第二血管中；
每一个可机械扩张的设备能从第一个位置扩张到第二个位置，所述可机械扩张的设备径向地向外扩张至第二个位置，使得所述可机械扩张的设备的外表面与血管内表面贴合从而保持住通过所述血管的流体通路；以及
膜，其可响应于所述可机械扩张的设备的扩张，从第一个位置扩张至第二个位置，所述的膜扩张至第二个位置时能阻碍血液循环到动脉瘤，膜的至少一部分固定到每一个可机械扩张的设备，以在扩张至第二个位置时，保持膜相对于可机械扩张的设备的位置。
在第三个方面，本发明提供了一种方法，用于制造如上所述的医疗设备，所述方法包括：
将基本为管状的结构放置到型芯上；以及
将膜放置到可机械扩张的设备的外表面。
在第四个方面，本发明提供了一种方法，用于制造如上所述的医疗设备，所述方法包括：
将基本为管状的结构放置到型芯上；以及
将膜包括进支架的撑条之间。
所述放置可以是由喷雾、缝合、层压、粘附、加热和浸渍涂布构成的组中的任何一种。
本发明的至少一种实施方式的一个目的是，通过机械方式密封或阻碍血液循环到动脉瘤，使得动脉瘤最终凋萎。
附图说明
现在将参考附图来描述本发明的实施例，其中：
图1A和1B是两种示例性的可通过球囊扩张的支架；
图2示出了自身扩张的支架；
图3A是放置到动脉瘤位置的支架的示意图；
图3B是与图3A类同的示意图，不同之处在于，支架的一部分由张开的网格形成；
图4示出了一种运送系统，其中具有在球囊上扩张的支架；
图5是一种支架的示意图，所述支架的部分被具有口袋(pocket)的膜所覆盖；
图6是作为被两个环状支架支持的膜的套管(sleeve)的剖视图；
图7是连接两个支架以治疗二叉动脉瘤的膜的示意图；
图8是一种动脉瘤的示意图，其被支架的膜所覆盖，以阻碍血液循环到动脉瘤；
图9是针对支架的典型尺寸的表；
图10是一种支架的示意图，所述支架具有膜，膜具有孔的图案；
图11是一种支架的示意图，所述支架具有膜，膜具有聚合物条带；
图12是一种支架的示意图，所述支架具有膜，膜具有网孔；
图13是固定到支架的撑条的膜的示意图；
图14是在支架展开之前膜的示意图；
图15是具有下述膜的支架的示意图，所述膜固定于三种不同位置并且具有三种不同大小；
图16是一种膜的示意图，所述膜可在血管中浮动(flipping)，而非紧靠血管壁停留。
附图详述
可植入的医疗设备包括用于将药物或试剂运送到人体内血管系统中期待位点的物理结构。可植入的医疗设备可以具有多种多样的形状和构型，这取决于特定的应用。常见的可植入医疗设备包括支架、腔静脉滤器、移植物和动脉瘤线圈。虽然仅对支架进行了描述，但是应当注意，公开的结构和方法还适用于所有其它可植入的医疗设备。
人体的内血管系统包括血管、脑循环系统、气管支气管系统、肝胆汁系统、食道肠系统以及尿道系统。虽然描述了血管中的示例性可植入支架202，它们还可用于其它内血管系统。
支架202是可扩张的假体，用于保持人体的血管以及内腔导管或管道(例如，通过球囊血管成形术进行动脉扩张之后冠状动脉内腔的一部分)张开和不闭塞。典型的支架202通常为管状结构，其具有大量相互连接的撑条确定的外表面，所述撑条间具有空隙空间。通常为管状的结构可从第一个位置(其中，所述支架大小可进行血管内插入)扩张至第二个位置(其中，支架外表面的至少一部分接触血管壁)。支架的扩张由在通常为管状的结构中相互连接的撑条的挠性和弯曲提供。应当考虑到，可以产生很多种不同的支架设计。对于获得多种设计目标而言(例如增大强度、最大化扩张率或覆盖面积，增大扩张时的纵向挠性或纵向稳定性等)，大量的撑条图案是已知的。可以选出一种图案而非另一种，是为了使对特定应用来说特别重要的那些参数最优化。
参考图1A和1B，提供了两种示例性的可通过球囊扩张的支架设计。图1A示出了管状的可通过球囊扩张的支架100，其具有末端标记103，以增加支架100的可视性。支架100由环101、环连接物102和末端标记103的支架撑条构成。
参考图1A，支架100由多种依情况而定的环101制成，其中，环连接物102连接两个或三个相邻的环101，以将环保持在适当的位置。关于末端标记103，图1A示出了“圆盘”状的标记。实际上，该形状并不重要，只要该标记能用于进一步增加支架100的可视性即可。图1B示出了管状的可通过球囊扩张的支架104，其类似于图1A示出的支架100，不同之处在于支架104包含中央标记105、106。中央标记105、106帮助在植入操作期间定位动脉瘤开口。中央标记105、106可以采用与末端标记103相同的材料和形状。
参考图2，提供了自身扩张的支架107，其由线/带状物制成。虽然自身扩张的支架可以具有很多种设计，图2示出了具有典型麻花状图案108的支架107，其具有经焊接的末端109。支架107被设计为在其纵向轴上是相对挠性的，以有利于通过曲折的身体内腔的运送，但是在扩张条件下其径向上会足够硬和稳定，以保持在植入身体内腔中时身体内腔(例如，动脉)的不闭合。
接着参考图4，其示出了一种扩张的管状支架112。当管状支架112完全扩张为其展开直径时，撑条的格子呈现出下述形状，其中，相邻顶点经历很宽的分离，相对支架的纵向轴而言，撑条的多个部分呈现出横向的，几乎完全侧向的定向。大量支架的此类侧向定向使得每个完全张开的网格能对支架在其完全展开的状况下提供的牢固的机械支持有贡献，以确保刚性结构，其能高度抵抗支架展开之后血管壁的反冲。
虽然，例如通过其上安装有支架的球囊导管的球囊的有效膨胀所施加的向外方向的径向压力，支架可通过径向扩张展开，但是，支架112还可以是可自身扩张的。在一些情况下，预成型弹性(即，自身张开的)支架的被动回弹特征可用于该目的。支架因此扩张，以贴合血管壁的内层，或在朝向内部的表面，其具有足够的回弹力，以允许一些收缩，并还具有足够的硬度，以在很大程度上抵抗血管壁的天然反冲。
在一种实施方式中，可植入的医疗设备是颅内支架202以及用于狭窄(stenotic)损伤和动脉瘤201的运送系统，由于颅内血管的特征，颅内支架202被设计为：非常具有挠性，轮廓小(当折叠在运送导管上时，为0.033”-0.034”，或者甚至更小)，以及薄壁(0.0027”-0.0028”)。颅内支架202不必须具有最高可能的径向强度，因为对颅内应用而言不必需要有高强度。颅内支架的辐射不能透过性可通过包括不能透过辐射的标记205(用金或铂制成)来提供，或者通过用铂/铱/钨合金制备支架202来提供。用于治疗动脉瘤201的支架202在其主体中间具有特殊类型的铂“星标记”204，以协助在血管瘤颈201上对支架202进行精确指示和对准，以允许对血管瘤201进行进一步操作。
如图3A所示，颅内支架202被放置在血管瘤201的位置处。膜203部分覆盖支架202，其定位于能密封血管瘤201的颈的位置。辐射不能透过的标记204定位于支架202的中间，以在操作和操作后观察期间提供对支架202的可视性。参考图3B，支架202的一部分由张开的网格205形成。该设计能避免对穿孔的妨碍。穿孔指具有重要且有特色的供血功能的小毛细血管。管状支架能妨碍穿孔、抑制其重要功能是有可能的。
参考图4，运送系统包括导线内腔110、球囊膨胀内腔111、连接物116、球囊导管轴113以及导管轴113上的铂标记条带115。导线内腔110用于将导线引入球囊导管，球囊膨胀内腔111用于在待放置支架到达其目标位置之后使球囊膨胀。连接物116用于分开导线内腔110和球囊膨胀内腔111。球囊导管轴113单独地携带导线内腔110和球囊膨胀内腔111，其典型长度为大约135-170cm。导管轴113上的环状标记115用于示出球囊锥形的起点以及支架的边缘。图3中，扩张的支架112被显示为：安放在扩张的球囊之上。运送导管可以基本上是用于血管成形术的传统球囊膨胀导管。球囊可由合适的材料形成，例如，辐射聚乙烯、聚对苯二甲酸乙二醇酯、聚氯乙烯、尼龙和共聚尼龙，例如PebaxTM。还可以使用其它聚合物。为在运送到动脉中期待位置的过程中，使支架留在球囊上的适当位置，支架可折在球囊上。
在一种优选的实施方式中，支架的运送通过下述方法完成。首先将支架安放到运送导管末端的可膨胀球囊上。将支架机械地折叠于叠起的球囊的外表面。通过引导型导管将导管/支架组件引入脉管系统。将导线布置为穿过有疾病的动脉部分，然后导管/支架组件在动脉中的导线上前进，直到支架被引导到有疾病的内层正下面。导管球囊扩张，使得支架抵抗动脉扩张。扩张的支架用于在导管撤出之后保持动脉的张开。由于支架形成自狭长的管，支架的圆柱形元件的波浪状组件在横截面中相对较平，使得支架扩张开时，圆柱形元件被压进动脉壁，结果不会干扰到流经动脉的血液。被压进动脉壁的支架圆柱形元件最终将被内皮细胞层覆盖，这样可以进一步最小化对血流的干扰。此外，以规律间距存在的紧密相隔的圆柱形元件提供了对动脉壁的均匀支持，因此能很好地适用于在动脉壁中固定和适当保持小的瓣或片。
对有回弹性的或者可自身扩张的假体而言，它们无需膨胀球囊就能展开。可根据血管或其它目标固定位点的直径来预先选择可自身扩张的支架。虽然它们的展开需要支架定位的技术，但是此类展开不需要小心地使球囊膨胀以使假体塑性扩张为合适直径的额外技术。此外，可自身扩张的支架在固定之后保持至少轻微的弹性压缩，因此具有复原力，能协助迅速固定。相反，塑性扩张的支架必须依赖变形组织的复原力，或者依赖钩、倒钩或其它独立的固定元件。
支架在血管中的存在有可能促使血栓随着血液流经血管而形成，这将导致急性阻塞。此外，因为支架朝外的表面接触或贴合血管内层，对组织的刺激可能使再狭窄恶化，这可以是增生导致的。此外，人们想要将药物或试剂运送到动脉中，以增加对流向动脉瘤的血流的阻塞。最后，可植入的医疗设备已被用作为媒介，以将药物或试剂运送到人体血管系统中特定的位置。
在一种实施例中，颅内支架202被针对低压展开特别设计。支架202具有足够的径向强度，用于脆弱的颅内血管的特定环境。支架202被设计为：允许赋予高的支架性能和完全相容的纵向挠性。
支架的低压展开被定义为：等于或低于4atm的压力。该水平的压力能使支架202完全展开，支撑狭窄的颅内血管或动脉瘤颈201，而不会引入目标血管的损伤或破裂(rapture)。可使用球囊技术来展开支架202，或者该支架是可自身扩张的。
支架202包含限制扩张势能的结构元件，其匹配血管内径，使得展开极度精确。结构元件的特征与低压展开的组合明显降低了血管受伤、破裂或再狭窄。
支架202还具有等于或好于运送导管所提供的纵向挠性。这意味着，支架不会向设备增加提高的刚度。支架202的跟踪能力(trackability)取决于导管的机械性质，不受支架202单独限制。可通过施加数克的力，使支架从中线挠曲来测量支架202的纵向挠性。该力使得支架对于小于8克的力挠曲1mm。现有的导管可以提供20-22克的力/1mm挠曲。当制造适合特定血管的支架时，该条件也非常重要，其保护血管免受可能的创伤反应。
支架202的结构被设计为：提供18-19克/mm长度的归一化的径向的力，可能达到接近于在现有的冠状动脉支架中发现的值的值。支架结构支持提供：随着颅内血管壁的天然脉冲，3-4％的支架结构挠曲。这使支架更好地符合血管情况，使得血管损伤减少。
颅内支架202具有以压缩运送模式存在的轮廓.020”
颅内支架202被设计为：压缩到轮廓低至0.14”-0.16”的运送导管上，具有0.20”-0.22”的支架轮廓。
颅内支架202具有均匀的材料分布和壁覆盖，产生了需要的血管支持。材料比例(material ration)在10-17％的范围内，这取决于展开的直径。
颅内支架202具有不超过0.028”的撑条厚度和宽度。撑条的尺寸被选择为：产生最小的侵入性撑条材料体积，以及减少对血管的损伤。
支架表面积与长度比被设定为1.1-1.3mm2/mm，以提供最小的血管损伤。
至少一种膜203被放置到支架202的外表面上。膜203包含口袋，其被用作为药物或试剂的容器，以将药物或试剂运送进血管系统。膜203覆盖支架202的一部分，如图3A和3B所示，其中膜203的大小可随应用变动。在一种实施例中，膜203覆盖支架202的整个外表面。因此，膜203可以是任何形状和大小的。
在某些实施方式中，膜203包含附着到可植入医疗设备，例如支架202外表面的第一层。中间层附着到第一层上，其中，中间层包含至少互相分开的两个环绕条带，第二层覆盖第一层和中间层。第一层、环绕条带和第二层包围的空间形成用作为药物或试剂容器的口袋。在其它实施方式中，中间层包括至少一处开口，使得口袋可在开口中形成。开口的形状和大小可根据具体应用变化。如图5所示，支架202被膜203部分覆盖，所述膜203包含第一层206和第二层207。图5还示出了药物释放孔208。
很多聚合材料适合用于制造膜203的层。典型地，一层第一层被放置到支架外表面。第一层具有0.002”-0.005”的厚度，20-30微米的孔径，接近名义的初始直径。
在某些实施方式中，第一层作为独立膜203用于机械性地覆盖和密封动脉瘤201。在某些实施方式中，第一和/或第二层可由生物可降解的材料构成，作为药物或试剂载体用于持续释放。
理想的是，中间层由能融合到第一和第二层上或以不同方式附着到第一层上的材料形成。在某些实施方式中，中间层可与第一层合并，形成单一的层，其中，在合并的层的外表面上有凹陷。
第二层和中间层可由下述生物可降解材料构成，所述材料含有用于立即释放或持续控制释放的药物或试剂。生物可降解的材料历经降解过程之后，膜203仍保持完整，提供对血管的支持。
第二层可由聚合材料构成。在优选的实施方式中，第二层具有大约0.001”的厚度以及大约70-100微米的孔径。
聚合层还可由选自如下组的材料形成，所述组由氟聚合物、聚酰亚胺、硅酮、聚氨酯、聚氨酯醚(polyurethanes ethers)、聚氨酯酯(polyurethane esters)、聚氨酯脲及其混合物和共聚物组成。也可使用生物可降解的聚合材料。
可融合的聚合物层可通过粘附、层压或缝合的方式结合到一起。聚合物层的融合可以通过多种技术获得，例如，热封、溶剂结合、粘合剂结合或使用涂布。
可证明有利的药物或试剂包括能减少血栓、炎症或血管的平滑肌细胞对可植入医疗材料的增生性反应的物质。例如，细胞抑制剂可被运送，以抑制平滑肌细胞的增生。在颅内或一些其它应用中，可使用纤维蛋白密封剂，将其运送以密封动脉瘤颈，提供纤维原细胞和内皮细胞的生长。药物或试剂的特殊例子可以包括：肝磷脂、磷酸胆碱、清蛋白、地塞米松、紫杉醇(paclitaxel)和血管内皮生长因子(VEGF)。
药物或试剂可以以多种方式被包括进可植入医疗设备。例如，药物或试剂可以以凝胶、液体或粉末形式注射进口袋容器中。或者，药物或试剂可以以已形成为固体药片的粉末提供，所述药片位于所述容器中。
成功处理这些极小直径血管的另一先决条件是，支架运送系统高度具有高度挠性，以允许其沿着脑循环解剖构造(anatomy)前进。此外，总的支架运送系统应当具有极小的轮廓，以治疗有疾病的颅内动脉，所述动脉通常在1.5mm至5mm的范围内。
参考图6，在某些实施方式中，膜203被实现为套管301，其被处于设备两端的两个环状短支架302所支持，使得膜203覆盖设备302的整个区域。在设备302的中间没有骨架支持。辐射透不过的标记303被放置于支架302的两端。取决于应用，环可以是球囊扩张的，或者由不锈钢制成，或是NiTi(形状记忆型镍钛合金)制成的可自身扩张的。
膜203是出血支架结构的一部分，其被设计为能有效闭塞动脉瘤颈，使血管“复通”。其将允许对血管的重新构建，从本质上消除血管瘤。不需要昂贵(并且外伤性的，一些时候过于沉重的)弹簧圈是能预计到的。
该设备对于治疗巨大并且宽颈的动脉瘤，二叉和三叉动脉瘤来说是优选的方案。其对于海绵窦、伪动脉瘤、囊状动脉瘤中形成瘘管来说也是优选的治疗方案。
膜203是有弹性的，以允许其自身扩张五至六倍，而不会裂解和与支架结构分离。膜203的厚度被预计为：在折叠位置不超过.002”，在扩张形式中不超过.001”。机械性质不会向颅内支架202中引入额外刚度，对支架扩张不具有阻抗性。膜材料还允许扩张的膜203忍耐正常血压。
膜203可由固体聚合物制成。或者，膜203不是固体的，其形成为支架撑条间的条带，或具有一系列的洞或椭圆形孔。膜203因此可以是有孔的或织网。还可以下述方法来设计和构建膜203，所述方法使得，存在洞的系统，以允许血液流进穿孔系统，而不允许其流进动脉瘤201。
对于虹吸管(Siphon)之上的脑动脉而言，有孔的、可透过的膜203是理想的。此类膜203可治疗动脉瘤颈201，而不会阻碍微血管(穿孔)。预计到，介入式神经放射师更愿意使用所述膜203，而非其它已知技术来处理动脉瘤颈201。可透过的膜203具有下述洞或孔的系统，它们之间的边界不大于100微米。洞或孔可以在50至100微米的范围内。膜203能显著改善动脉瘤201周围的血液动力学，因为其较之具有固体膜203的支架202而言，具有较矮的运送轮廓，也更有挠性。
对于发生在眼动脉以下的动脉瘤201而言，膜203优选由固体聚合物制成，因为，不期望的阻碍穿孔的风险会减少。
膜203附着到支架撑条上。可以使用喷雾、浸渍技术或热结合到中间聚合物层上来附着膜203。支架202被放置到型芯(硬PTFE或金属)上，或者悬挂到钩上，喷上PU溶液，采用快速干燥工艺进行固化。或者，支架被放置到型芯或钩上，浸没于PU溶液中。
生物可降解的膜203能进行药物运送，并且随后溶解。存在有多种应用，其中，在植入后超过15至20天后，不需要膜203存在，因此，膜203可被溶解。
膜203可由PU、硅酮或任何其它有弹性的医疗级别聚合物制成。
参考图7，提供了膜203，用于二叉支架202，以治疗二叉或三叉动脉瘤201。动脉瘤的至少30至35％位于颅内血管的二叉位点。该膜203是一侧的，不环绕的。二叉支架202联合膜203，覆盖动脉瘤颈201。同样的图案可应用于可自身扩张的(超级弹性的)或者可通过球囊扩张的(不锈钢、CoCr、PtIr合金)支架202。
参考图8，动脉瘤201被颅内支架202的膜203所覆盖，用于治疗和防止缺血和出血性中风。颅内支架202偶联膜203，用作为骨架，以张开被阻塞的动脉，以及作为盖子，以预防血液向动脉瘤201循环。
阻碍向动脉瘤201的血液提供使得动脉瘤201与正常血液循环分开，因此最终导致其凋萎。对动脉瘤的完全阻碍可能并不必须。
图9提供了与膜203一起使用的颅内202的典型尺寸表格。用于膜203的材料是生物相容性的，具有对不锈钢316L制成的支架撑条的良好粘附性，其由稳定的膜片形成。在其它实施方式中，膜片是血液“可透过的”，而非固体膜。被覆盖的部分，即，孔或洞之间的边界，不超过75μm，以防止支架202或膜203的任何部分阻碍穿孔。若干种选择可用于完成该目的。膜203可由宽度不超过0.001”的薄膜片制成。膜片具有良好的扩张性，其在低的力度下能扩张高达400％。膜203在环境条件下还具有保质期或化学稳定性，在灭菌条件(Eto)下是稳定的。
在一种实施例中，聚氨酯被用于制造膜203。具体地，使用溶液级别的、芳香的、基于聚碳酸酯的聚氨酯。物理性质是：硬度(Shore)为75A，拉伸强度为7500psi，伸长率达500％。
参考图10，为制造可透过的膜203，在固体膜片上钻洞，以形成孔。孔的大小在0.025至0.050mm之间，而孔之间的距离小于100μm。
参考图11，聚合物的螺纹(threading)条带203侧向包裹支架202。条带在支架的撑条上下交错。条带宽度小于0.075mm，相邻条带之间的距离小于100μm。
参考图12，编织材料203的薄片包裹支架202。薄片的网格尺寸为大约0.025-0.050mm，而聚合物宽度小于100μm。
参考图13，膜片203完全围绕支架撑条，其是支架撑条之间的稳定固体膜片。撑条之间的膜片在撑条中或在外层撑条上。聚合物膜片尽可能地紧靠血管壁。这是为了使图16所示的在血管中的“浮动”最小化。
参考图14，膜203固定到撑条上，难于使其离开支架202或将其与支架202扯开。膜203的厚度不会对皱褶的组件增加任何显著的轮廓，即，其仅为皱褶的支架轮廓贡献小于0.001”的厚度。膜203还具有均匀的收缩性。
参考图15，膜203可完全覆盖支架202，覆盖支架202的中间部分，或者覆盖支架202的径向部分。膜203随支架202扩张，不会限制或改变支架202的扩张特性。膜203易于扩张达400％。膜203对支架202的机械性质，例如挠性、跟踪能力、扩张能力、反冲以及缩短具有最小的作用。膜203在自然的保质期条件下是稳定的，在灭菌条件(Eto)下也是稳定的。聚合物膜片的性质在灭菌之后仍会保存下来，不会改变。折叠之后，膜203不会粘到球囊材料(尼龙)上。膜203能忍耐温度变化(高达60C)。膜203的边缘是审美学上可接受的，其具有平滑的、不粗糙的边缘。
本领域技术人员将知道，可不偏离广泛描述的本发明的范围或宗旨，对特定实施方式所示的本发明作出大量改动和/或改良。因此，在所有方面，本发明的实施方式都应当被考虑为阐述性的，而非限制性的。
权利要求书(按照条约第19条的修改)
1.一种医疗设备，用于插入到身体血管中，以治疗颅内动脉瘤，所述设备包含：
可机械扩张的设备，其能从第一个位置扩张到第二个位置，所述可机械扩张的设备径向地向外扩张至第二个位置，使得所述可机械扩张的设备的外表面与血管内表面贴合，从而保持住通过所述血管的流体通路；以及
膜，其可响应于所述可机械扩张的设备的扩张，从第一个位置扩张至第二个位置，所述的膜扩张至所述第二个位置时被定位于动脉瘤附近，阻碍血液循环到动脉瘤，所述膜的至少一部分固定到所述可机械扩张的设备，以在扩张至所述第二个位置时，保持膜相对于可机械扩张的设备的位置；
其中，所述膜是可透过的，并且有孔的，所述膜的洞或孔使得向主要脑动脉的细微分支和穿孔提供血液是允许的，而向所述动脉瘤提供血液是被阻止的。
2.如权利要求1所述的设备，其中，所述可机械扩张的设备包含基本为管状的结构，其具有由多个相互连接的撑条确定出的外表面，所述撑条之间具有空隙空间。
3.如权利要求1所述的设备，其中，所述的膜由生物相容的、弹性聚合物制成。
4.如权利要求1所述的设备，其中，所述的膜具有大约0.001至0.005”的厚度，具有大约20至100微米的孔径或洞径。
5.如权利要求1所述的设备，其中，所述的膜由聚合材料或生物可降解的材料制成。
6.如权利要求5所述的设备，其中，所述生物可降解的材料可以形成混合有药物或试剂的多个亚层。
7.如权利要求1所述的设备，其中，所述的膜可以能进行各向同性扩张。
8.如权利要求1所述的设备，其中，所述的膜被放置于所述设备的外表面。
9.如权利要求1所述的设备，其中，所述的膜完全包围所述设备。
10.如权利要求1所述的设备，其中，所述的膜呈圆周形地环绕所述设备的一部分。
11.如权利要求1所述的设备，其中，所述的膜覆盖所述设备的一部分。
12.如权利要求1所述的设备，其中，所述的膜是无孔的且不能透过的，以防止血液循环到所述动脉瘤中。
13.如权利要求12所述的设备，其中，所述的膜由固体聚合物制成。
14.如权利要求1所述的设备，其中，所述的膜具有大小在20至100微米之间的孔。
15.如权利要求1所述的设备，其中，所述的膜制造有大小在20至100微米之间的洞。
16.如权利要求15所述的设备，其中，所述的洞可以通过激光钻孔来制造。
17.如权利要求14或15所述的设备，其中，所述孔或洞之间的距离可以小于100μm。
18.如权利要求1所述的设备，其中，所述的膜包括固定到可机械扩张的设备的多个聚合物条带。
19.如权利要求20所述的设备，其中，所述条带小于0.075mm，相邻条带之间的距离小于100μm。
20.如权利要求1所述的设备，其中，所述的膜包含固定到机械扩张的设备的网。
21.如权利要求20所述的设备，其中，网孔间隔小于100μm，网孔的宽度在0.025至0.050mm之间。
22.如权利要求1所述的设备，其中，所述动脉瘤是常规大小的、巨大的或宽颈动脉瘤。
23.如权利要求1所述的设备，其中，所述可机械扩张的设备可以是可自身扩张的或可通过球囊扩张的。
24.如权利要求1所述的设备，其中，所述可机械扩张的设备是支架。
25.如权利要求2所述的设备，其中，所述膜被基本为管状的结构所支持，并且附着到至少一个撑条上。
26.如权利要求24所述的设备，其中，所述膜是管状的，其具有与支架的名义初始直径相似的直径；以及，其中，所述膜被放置到所述支架的外表面上，或通过浸渍涂布或喷雾引入到所述支架的撑条之间。
27.如权利要求24所述的设备，其中，所述的膜是放置到所述支架外表面一部分上的管状结构的部分。
28.如权利要求6所述的设备，其中，至少一种试剂是选自由固体药片、液体和粉末构成的组的任何一种形式。
29.如权利要求1所述的设备，其中，在所述可机械扩张的设备上提供至少一种不可透过辐射的标记，以提高插入期间和插入后所述设备的可视性。
30.如权利要求29所述的设备，其中，所述至少一种不可透过辐射的标记由金或铂制成。
31.如权利要求29所述的设备，其中，在所述可机械扩张的设备上提供中央的不可透过辐射的标记以及末端的不可透过辐射的标记。
32.一种医疗设备，用于治疗至少两根身体血管之间的二叉或三叉颅内动脉瘤，所述设备包含：
第一可机械扩张的设备，用于插入到第一血管中；
第二可机械扩张的设备，用于插入到第二血管中；
每一个可机械扩张的设备能从第一个位置扩张到第二个位置，所述可机械扩张的设备径向地向外扩张至第二个位置，使得所述可机械扩张的设备的外表面与血管内表面贴合从而保持住通过所述血管的流体通路；以及
膜，其可响应于所述可机械扩张的设备的扩张，从第一个位置扩张至第二个位置，所述的膜扩张至所述第二个位置时定位于动脉瘤附近，阻碍血液循环到动脉瘤，所述膜的至少一部分固定到每一个可机械扩张的设备，以在扩张至第二个位置时保持所述膜相对于所述可机械扩张的设备的位置；
其中，所述膜是可透过的，并且有孔的，所述膜的洞或孔使得向主要脑动脉的细微分支和穿孔提供血液是允许的，而向所述动脉瘤提供血液是被阻止的。
33.用于制造根据权利要求1所述的医疗设备的方法，所述方法包含：
将基本为管状的结构放置到型芯上；以及
将所述膜放置到所述可机械扩张的设备的外表面。
34.用于制造如权利要求24所述的医疗设备的方法，所述方法包含：
将基本为管状的结构放置到型芯上；以及
将所述膜包括进支架的撑条之间。
35.如权利要求33或34所述的方法，其中，所述放置是由喷雾、缝合、层压、粘附、加热和浸渍涂布构成的组中的任何一种。
36.如权利要求24所述的设备，其中，通过运送导管将所述支架运送到血管瘤处。

Claims (38)

1.一种医疗设备，用于插入到身体血管中，以治疗动脉瘤，所述设备包含：
可机械扩张的设备，其能从第一个位置扩张到第二个位置，所述可机械扩张的设备径向地向外扩张至第二个位置，使得所述可机械扩张的设备的外表面与血管内表面贴合，从而保持住通过所述血管的流体通路；以及
膜，其可响应于所述可机械扩张的设备的扩张，从第一个位置扩张至第二个位置，所述的膜扩张至所述第二个位置时能阻碍血液循环到动脉瘤，所述膜的至少一部分固定到所述可机械扩张的设备，以在扩张至所述第二个位置时，保持膜相对于可机械扩张的设备的位置。
2.如权利要求1所述的设备，其中，所述可机械扩张的设备包含基本为管状的结构，其具有由多个相互连接的撑条确定出的外表面，所述撑条之间具有空隙空间。
3.如权利要求1所述的设备，其中，所述的膜由生物相容的、弹性聚合物制成。
4.如权利要求1所述的设备，其中，所述的膜具有大约0.001至0.005”的厚度，具有大约20至100微米的孔径或洞径。
5.如权利要求1所述的设备，其中，所述的膜由聚合材料或生物可降解的材料制成。
6.如权利要求5所述的设备，其中，所述生物可降解的材料可以形成混合有药物或试剂的多个亚层。
7.如权利要求1所述的设备，其中，所述的膜可以能进行各向同性扩张。
8.如权利要求1所述的设备，其中，所述的膜被放置于所述设备的外表面。
9.如权利要求1所述的设备，其中，所述的膜完全包围所述设备。
10.如权利要求1所述的设备，其中，所述的膜呈圆周形地环绕所述设备的一部分。
11.如权利要求1所述的设备，其中，所述的膜覆盖所述设备的一部分。
12.如权利要求1所述的设备，其中，所述的膜是无孔的且不能透过的，以防止血液循环到所述动脉瘤中。
13.如权利要求12所述的设备，其中，所述的膜由固体聚合物制成。
14.如权利要求1所述的设备，其中，所述的膜是可透过的，并且有孔的。
15.如权利要求14所述的设备，其中，所述的膜具有洞或孔，使得向主要脑动脉的细微分支和穿孔提供血液是允许的，而向所述动脉瘤提供血液是被阻止的。
16.如权利要求15所述的设备，其中，所述的膜具有大小在20至100微米之间的孔。
17.如权利要求15所述的设备，其中，所述的膜制造有大小在20至100微米之间的洞。
18.如权利要求17所述的设备，其中，所述的洞可以通过激光钻孔来制造。
19.如权利要求16或17所述的设备，其中，所述孔或洞之间的距离可以小于100μm。
20.如权利要求14所述的设备，其中，所述的膜包括固定到可机械扩张的设备的多个聚合物条带。
21.如权利要求1所述的设备，其中，所述条带小于0.075mm，相邻条带之间的距离小于100μm。
22.如权利要求14所述的设备，其中，所述的膜包含固定到机械扩张的设备的网。
23.如权利要求22所述的设备，其中，网孔间隔小于100μm，网孔的宽度在0.025至0.050mm之间。
24.如权利要求1所述的设备，其中，所述动脉瘤是常规大小的、巨大的或宽颈动脉瘤。
25.如权利要求1所述的设备，其中，所述可机械扩张的设备可以是可自身扩张的或可通过球囊扩张的。
26.如权利要求1所述的设备，其中，所述可机械扩张的设备是支架。
27.如权利要求2所述的设备，其中，所述膜被基本为管状的结构所支持，并且附着到至少一个撑条上。
28.如权利要求26所述的设备，其中，所述膜是管状的，其具有与支架的名义初始直径相似的直径；以及，其中，所述膜被放置到所述支架的外表面上，或通过浸渍涂布或喷雾引入到所述支架的撑条之间。
29.如权利要求26所述的设备，其中，所述的膜是放置到所述支架外表面一部分上的管状结构的部分。
30.如权利要求6所述的设备，其中，至少一种试剂是选自由固体药片、液体和粉末构成的组的任何一种形式。
31.如权利要求1所述的设备，其中，在所述可机械扩张的设备上提供至少一种不可透过辐射的标记，以提高插入期间和插入后所述设备的可视性。
32.如权利要求31所述的设备，其中，所述至少一种不可透过辐射的标记由金或铂制成。
33.如权利要求31所述的设备，其中，在所述可机械扩张的设备上提供中央的不可透过辐射的标记以及末端的不可透过辐射的标记。
34.一种医疗设备，用于治疗至少两根身体血管之间的二叉或三叉动脉瘤，所述设备包含：
第一可机械扩张的设备，用于插入到第一血管中；
第二可机械扩张的设备，用于插入到第二血管中；
每一个可机械扩张的设备能从第一个位置扩张到第二个位置，所述可机械扩张的设备径向地向外扩张至第二个位置，使得所述可机械扩张的设备的外表面与血管内表面贴合从而保持住通过所述血管的流体通路；以及
膜，其可响应于所述可机械扩张的设备的扩张，从第一个位置扩张至第二个位置，所述的膜扩张至所述第二个位置时能阻碍血液循环到动脉瘤，所述膜的至少一部分固定到每一个可机械扩张的设备，以在扩张至第二个位置时保持所述膜相对于所述可机械扩张的设备的位置。
35.用于制造根据权利要求1所述的医疗设备的方法，所述方法包含：
将基本为管状的结构放置到型芯上；以及
将所述膜放置到所述可机械扩张的设备的外表面。
36.用于制造如权利要求26所述的医疗设备的方法，所述方法包含：
将基本为管状的结构放置到型芯上；以及
将所述膜包括进支架的撑条之间。
37.如权利要求35或36所述的方法，其中，所述放置是由喷雾、缝合、层压、粘附、加热和浸渍涂布构成的组中的任何一种。
38.如权利要求26所述的设备，其中，通过运送导管将所述支架运送到血管瘤处。
CNA2004800431878A 2004-03-31 2004-12-13 一种医疗设备 Pending CN101394808A (zh)

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