CN101909545B - 具有通过柔性卷材相连的相邻元件的支架 - Google Patents

具有通过柔性卷材相连的相邻元件的支架 Download PDF

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CN101909545B
CN101909545B CN200980102566.2A CN200980102566A CN101909545B CN 101909545 B CN101909545 B CN 101909545B CN 200980102566 A CN200980102566 A CN 200980102566A CN 101909545 B CN101909545 B CN 101909545B
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support
stent
coiled material
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CN101909545A (zh
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D·C·伯卡特
E·H·库利
J·B·邓肯
C·L·哈特曼
J·D·西尔弗曼
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WL Gore and Associates Inc
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Gore Enterprise Holdings Inc
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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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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Abstract

具有柔性(优选聚合物)连接元件(32)的支架(60)，其中这些元件连接相邻且间隔的支架元件(62)。优选的，所述间隔的相邻支架元件是由螺旋缠绕蛇形线形成支架的结果，所述蛇形线在相邻的线圈之间具有空隙。其它形式的支架，例如多个、单个间隔的环形或互连支架元件也可使用。所述连接元件通常是网状的，且是通过在接枝材料的覆盖物中形成缝隙或孔，所述接枝材料施加到支架上，然后，通过例如施加热量以使所述缝隙或孔放大而形成的。剩余的接枝材料在所述相邻支架元件之间形成互连卷材。

Description

具有通过柔性卷材相连的相邻元件的支架
相关申请的交叉引用
本申请要求了2008年1月11日提交的美国临时专利申请61/020544的优先权。
技术领域
本发明涉及具有柔性连接的相邻支架元件的可植入(implantable)支架领域。
发明背景
自从多特(Dotter)于1960年代首次提出后，在脉管系统和其它身体管道中使用可植入支架已变得非常普遍。这些装置需要具有小的、紧凑的直径，以插入所需的身体管道和输送(通常通过导管)到所需的位点以展开，在该位点，它们膨胀到所需的较大直径以介入性地适应身体管道的内腔表面。球囊(balloon)扩张支架用可充气的球囊(所述扩张支架以紧缩状态预先安装在所述球囊上)使所述装置塑性变形来实现扩张，所述球囊附着在导管的远端(distal end)，并通过该导管充气膨胀。自扩张支架被强制压缩成小的直径，并通过限制套或其它装置限制在该直径。输送到展开所需的位点后，它们从限制状态释放，并弹开以接触所述身体管道的内腔表面。这些装置通常由镍钛金属合金(nitinol metal alloy)制成，且通常依赖该金属的超弹性(superelastic)和生物相容性。依赖该材料的形状记忆特性的镍钛支架也是已知的。
可植入支架的发展也包括使用安装在支架上的管状覆盖物，其可安装在支架的外表面或内腔表面，或者安装在这两个表面上。这些覆盖的支架通常也称为覆膜支架(stent-graft)。这些覆盖物通常是聚合的生物相容材料，例如聚对苯二甲酸乙二醇酯(PET)或聚四氟乙烯(PTFE)。例如参见授予帕尔莫茨(Palmaz)的美国专利4776337。
授予帕尔莫茨的美国专利4776337也公开了所述覆盖物可以任选具有穿孔(如果需要的话)，以用于特定的用途。由于所述穿孔提供了敞开区域，具有穿孔覆盖物的该装置可认为是一种支架和覆膜支架的杂合，因为该装置包括具有金属支架元件的支架框架和连接、覆盖或以其它方式附着到该支架元件上的聚合物元件。该聚合物元件的存在降低了相邻的金属支架元件支架原本存在的敞开空间，这稍微或者基本上取决于所需的用途以及机械设计。穿孔的覆膜支架也公开在其它地方，例如参见WO00/42949。
具有支架元件(其具有聚合物涂层或覆盖物)的支架也是已知的，例如参见授予梅尔斯(Myers)等人的美国专利5735892和授予平查基(Pinchuk)等人的美国专利5968091。
通常，可认为完全覆盖的覆膜支架的表面积(以下称为Amax)等于扩张的支架的外周长乘以支架的长度。对于常规的、开放框架(open frame)支架(相对于覆膜支架而言)，所有支架元件表示的表面积仅仅是最大表面积Amax的一小部分。该支架覆盖的实际表面积是指所有的支架组件(包括连接元件)在它们的展开状态所覆盖的面积，即A支架。孔隙率指数或P.I.表示开口面积(没有被支架组合件的所有组件覆盖的最大表面积的那部分)占最大表面积的百分数，其中：
P.I.＝(1-(A支架/Amax))×100％
测量由支架覆盖的实际表面积(A支架)的优选方法包括使用威斯康检测技术有限公司(Visicon Inspection Technologies，LLC，加利福尼亚州的纳帕市)所生产的机器。威斯康微细扫描TM(Visicon FinescanTM)支架检测系统(威斯康微细扫描机，型号85)使用了6000像素线扫描照相机来产生支架的平坦且未展开的视图。在操作中，将支架安装在具有微细扩散面积的蓝宝石芯轴(mandrel)上。该芯轴保持在线性阵列照相机下，并通过系统电子设备旋转，用于触发所述线性阵列照相机收集精确的线-线方式的图像数据线。完成旋转后，得到支架的完整图像。当对支架进行完整成像时，软件区分带有覆盖物的支架和背景。图像元素(像素)的总数量与相对于支架和覆盖物的像素总数量相比就可得到A支架。用于该类型测定的机器的基本设置是(例如)：光线，100％；曝光，0.3ms/线；增益，5；阀值，50；噪音过滤器，20；光滑度，4。
开口面积可以是连续的单一空间，例如单螺旋缠绕的支架元件的线圈(winding)之间的空间。同样地，所述开口面积可以由多个独立环形或环状支架元件之间的空间表示。所述开口面积也可以由多个孔的总面积来表示，所述孔可由单个支架元件(例如参见授予帕尔莫茨(Palmaz)的美国专利4776337的附图1B和2B)或者多个支架元件(提供多个孔)来提供。如果提供了多个孔，它们可以具有相等或不等的大小。使用除了金属支架元件外的聚合物元件或穿孔的覆膜覆盖物也可降低开口面积。
孔隙率指数大于50％的支架可认为是基本上开放式的支架。
除了孔隙率指数，如果仅仅需要覆盖一部分支架面积以用于特定的用途，必需考虑提供开口面积的任意孔的大小。对于多个孔，通常必需考虑任意单个孔的最大尺寸，特别是所述孔用于提供“过滤”效果，从而控制或限制生物材料从内腔壁进入身体管道的流动空间。
组合金属支架元件和聚合物连接元件的各种支架装置是已知的，例如参见授予梅达(Maeda)等人的美国专利5507767。另一种是具有柔性针织套的支架，该柔性针织套具有链节栅栏形式的小开孔，购自灵感MD有限公司(InspireMD Ltd.)(以色列，特拉维夫67892，得利齐哈萨隆街4号Derech Hashalom)。
发明内容
公开了一开放式种支架(该支架具有位于所述支架两端之间的多个位置且穿过其厚度的开口空间)及其制造方法。所述支架将柔性(优选聚合物)连接元件(即聚合物卷材(web))加入到支架中，其中这些连接元件连接相邻且间隔的支架元件。该柔性(优选聚合物)连接元件提供了使所述支架元件保持相等间隔的装置，且使支架的构造具有良好的柔性以及抵抗在体内可能施加于所述装置的力，例如扭力、弯曲力、轴向拉力或压缩力或径向压缩力。
优选地，所述间隔且相邻的支架元件的形式是聚合物卷材。较好的支架形式是螺旋缠绕蛇形线(helically wound serpentine wire)，其具有相邻的线圈之间的空间。也可使用其它支架形式，例如多个、独立间隔的环状支架元件。环状支架元件的形式可以是Z字形元件，形成环绕环，或者互连元件(当装置径向扩张时，该互连元件在环向序列中提供菱形开孔)。或者，使用螺旋缠绕蛇形形式的实施方式对于许多用途来说是优选的。该支架优选是自膨胀的(由诸如镍钛合金的材料制成)，但是也可以由适用于球囊扩张支架的材料(例如不锈钢、镁基合金、镁、钴铬合金、钛或钛基合金)制成。
在没有次级连杆连接相邻行(secondary linkage connecting adjacent row)的情况下，螺旋缠绕支架框架本身是不稳定的。使用所述的聚合物卷材连杆(linkage)来互连相邻行可稳定该螺旋结构，并限制轴向拉伸、扭曲和弯曲，同时得到高的柔性。
相邻且间隔的支架元件优选基本上是环向取向的，表示当所述支架处于笔直且未弯曲的状态时，它们的取向方向通常垂直于所述支架的纵轴。
制造方法包括将生物相容聚合物覆盖物施加到所选择的支架形式上，以临时形成覆膜支架。该覆盖物优选是坚固且薄的材料，可以是管状形式，尽管片状形式(例如由较宽的膜切成窄的条)对于制造所述的支架是优选的。所述覆盖物较好施加的所述支架的外表面上，但是也可仅施加到内腔表面上，或者可施加到支架的内腔表面和外腔(abluminal)(外)表面。覆盖内腔表面和外腔表面使得用所需的聚合物基本上覆盖支架的所有金属表面成为可能。所述聚合物膜覆盖物优选是热塑性膜，较好是具有一定强度性质的膜，该强度在所述膜加热到高于其熔点的温度时能够产生较均匀的定向收缩特性。该膜覆盖的覆膜支架具有穿过所述膜厚度的刺孔(puncture)(缝隙或其它孔)，优选在相邻支架元件之间的位置(具体参见下述)。然后将刺孔的覆膜支架加热到所述膜的熔融温度以上，使所述膜从先前形成的刺孔边缘收缩回，形成穿过所述支架壁的开口。这些开口的大小、形状、数量和取向取决于先前形成的刺孔的大小、形状、数量和取向，随后施加的热量以及所用聚合物膜的厚度和类型。显然，这些制造变量可根据需要进行控制。所述支架所得开口面积(即孔隙率指数)可覆盖较宽的范围(即10％，20％，30％，40％，50％，60％，70％，75％，80％，85％，90％，95％或更高，或者这些百分数中任意两个之间的数值)。加热步骤之后的剩余聚合物膜的形式是在相邻支架元件之间延伸的聚合物卷材。
另一种制造方法也包括将生物相容聚合物覆盖物施加到所选择的支架形式上，以临时形成覆膜支架。在该实施中，优选的支架形式可以是由合适的球囊扩张材料形成的环形支架元件。所述覆盖物与前述的覆盖物相同，且可用与前述相同的方法施加到所选择的支架形式上。所述聚合物膜覆盖物优选是热塑性膜，且较好是具有单向强度性质的膜。所述膜覆盖的覆膜支架具有穿过所述膜厚度的刺孔(缝隙或其它孔)，较好在相邻支架元件之间的位置(具体参见下述)。然后将所述刺孔的覆膜支架接枝充分加热以将所述膜粘结(bond)到所述支架形式上。当所得支架径向膨胀时，这些开口的大小、形状、数量和取向取决于先前形成的刺孔的大小、形状、数量和取向。显然，这些制造变量可根据需要进行控制。所得支架的开口面积(即孔隙率指数)可覆盖较宽的范围，例如前述的范围。刺孔/裂缝步骤之后的剩余聚合物膜的形式是在相邻支架元件之间延伸并互连相邻支架元件的聚合物卷材。
此外，完成的开放框架支架可任选具有其它聚合物覆膜材料的覆盖物，以形成覆膜支架(如果需要的话)。该覆膜覆盖物容易粘附或粘结到所述覆盖物或涂层上，所述覆盖物或涂层位于所述支架元件(例如线)上，且形成互连卷材。
这些完成装置(包括多个开口和多个聚合物互连卷材)的聚合物覆盖物通常在所述支架末端之间的连续或基本连续的，这是由连续聚合物片材制成的结果或者是使用具有重叠相邻边缘的螺旋缠绕(wrap)聚合物带的结果，该重叠相邻边缘熔融粘结在一起。形成这些连续卷材的膜覆盖物充分附着在所述支架元件上。
另外，可通过现有技术中已知的各种适合施加特定试剂的方法向这些装置提供各种治疗剂(例如肝磷脂)的涂层(优选是可洗脱涂层)。
用本文所述方法形成的支架具有良好的一致性，这是因为在相邻支架元件之间具有提供柔性和解剖学对位的柔性互连卷材。它们也具有良好的弯曲耐久性，这是因为在相邻支架元件之间具有提供减轻破裂的互连卷材，所述破裂是由于弯曲解剖结构(curved anatomies)中的环状纵向弯曲造成的。该可膨胀的装置的大小可变，以符合导管大小的范围(例如3-55毫米)。
本文所述的可膨胀的装置的潜在临床应用包括但不限于：先天性缺陷(即肺动脉狭窄、主动脉缩窄)、主动脉辅助治疗(例如I型内漏、主动脉侧支植入支架)、末梢动脉疾病(例如肾动脉和髂动脉狭窄、动脉瘤和剖开术)以及静脉用途。
附图说明
图1A和1B分别描述了本文所述优选支架的螺旋缠绕蛇形线形式(先前已知)的透视图和俯视图。
图2A是相邻支架元件之间具有柔性互连卷材的螺旋缠绕蛇形线支架的一部分的侧视图。
图2B是图2A所示支架的展平的俯视图。
图2C和2D是俯视图，其中图2B所示的各个单一开口由多个孔代替，具体是图2C中是四个开口，图2D中是六个开口。
图3是用于制造所述开放框架支架的多轴ePTFE膜的扫描电镜图。
图4描述了部分完成的具有缝隙或刺孔的支架的侧视图，所述缝隙或刺孔是制造所述装置的方法的一部分。
图5A-5C描述了支架元件的横截面图，该支架元件显示为用于根据本文所述制备的最终支架。
图6A是球囊扩张支架(或该支架的长度部分)的侧透视图，该支架的相邻支架元件之间具有柔性互连卷材。
图6B是三个支架环的侧透视图，所述支架如所示没有互连聚合物覆盖物。
图6C是包括图6B中所述支架环的支架组件的侧透视图，其具有互连聚合物覆盖物。
图6D是图6C所述支架组件的上部左边部分，描述了透视细节部分。
图7是球囊扩张支架(或该支架的长度部分)的侧透视图，该支架具有相邻支架元件之间的柔性互连卷材。
图8是支架的侧视图，当该支架安装在随后展开和膨胀的球囊上时所显示的那样。
具体实施方式
已经注意到，如本文所述，各种支架形式较好可具有柔性互连元件。图1A描述了支架10的透视图，该支架10较好如本文所述使用。所示支架10包括一定长度蛇形线18的螺旋线圈。所述螺旋缠绕蛇形线18的连续线圈产生了间隔的相邻支架元件12。线18的末端17可通过任何合适的方法(例如焊接)固定到相邻的螺旋线圈上。为清楚起见，所示支架10具有芯轴16延伸过并超出所述支架内腔的两个末端，使侧面最接近观察者，从而使之明显可见，同时封闭支架10离观察者最远侧。芯轴16仅仅是为了进行清楚地观察，并不是支架10的一部分。
所述螺旋缠绕蛇形线18在支架10的相对末端之间连续延伸，其中由较小半径的线弯曲形成的相对顶点(apices)22a和22b通过笔直或较直的线部分24互连。所述顶点通常“指向”基本上平行于芯轴16的纵轴19的方向，且支架10的管状形式具有指向相对方向的交替的顶点22a和22b，即指向所述支架的相对末端。如图1A所示，指向一个方向的顶点(例如顶点22a)优选沿第一公用线对准，同时指向相对方向的顶点(例如顶点22b)沿平行第一公用线的第二公用线对准。
图1B描述了图1A所示蛇形线形式的细节的平面(或平展)图；尺寸相对于下述的制造方法。尺寸27认为是相邻的相对顶点的高度(振幅(amplitude))，而尺寸28是相邻的相对顶点的宽度。尺寸29描述了蛇形线形式的一个全周期。顶点22的弯曲半径26和线直径25可适当选择。
图2A是开口框架支架10的一部分长度的侧透视图，其中间隔的相邻支架元件12(例如两个相邻顶点22a链接相对的顶点22b)可通过一对柔性聚合物卷材32互连。图2B描述了该相同构造的平展的平面图。开口34存在于相邻对准的顶点22a之间；特定的单个开口18的形状通常是吉他拨片(guitar pick)形状。如果画一条通过独立的随机选择的卷材(即在相邻的且由卷材连接的线顶点之间延伸)的长度中心的线，该线优选相对平行于支架中心线(或平行于图1所示芯轴16的中心线19)的线成15-75度角。或者说，对于这类具有通过柔性卷材32互连的元件的支架而言，所述卷材32优选以相对于支架长度成一定角度取向。
图2B的放大部分描述了这些柔性聚合物卷材32如何在它们长度的中间部分窄于末端，所述聚合物卷材32在其末端附着在支架元件(例如镍钛合金线)上。它也描述了所述卷材32如何较好成切线地融入所述支架元件，所述卷材32在该融入位置粘结并附着在所述支架元件上。
图2C和2D是俯视图，其中图2B所示的每个单个开口被多个孔代替，具体地说，图2C中是四个开口，图2D中是六个开口。
尽管各种聚合物膜可适用作用于该装置的支架覆盖物(或涂层)材料，优选是与ePTFE膜组合使用的FEP(氟化乙丙烯)膜的组合。与这些螺旋缠绕蛇形线支架一起使用的优选ePTFE膜是具有多轴原纤取向(如图3的扫描电镜所示)的膜。它描述了所述原纤如何在ePTFE膜的平面内在所有方向上取向。这种类型的ePTFE膜可根据美国专利7306729和授予巴西诺(Bacino)等人的美国公开申请2007/0012624所示进行制造。相同类型的膜可任选具有FEP薄层的部分覆盖物(具有穿过该FEP膜覆盖物的开口；即不连续覆盖物)。FEP涂覆的ePTFE膜(具有不连续(多孔)FEP覆盖物(涂层)或连续(非多孔)FEP覆盖物(涂层))可通常根据授予梅尔斯(Myers)等人的美国专利5735892所示进行制造。
图4描述了部分完成的螺旋缠绕蛇形线支架13，其具有FEP膜的第一外(外腔)覆盖物和多轴ePTFE膜的其它覆盖物，其中穿过所述线的相邻顶点(apex)之间的膜制造纵向取向的缝隙41，所述线定位于相同的方向。向具有多个缝隙41的装置施加热量，使所述膜向着相邻线支架元件缩回，随后在完成的支架15(图2A)中形成开口。该方法具体参见下述。
如所述，尽管各种类型的膜可用于所述支架覆盖物，但是所述ePTFE膜是优选的，因为其具有多轴(在所述膜的平面内)强度取向。它是坚固的、薄的，且具有优良的生物相容性。当在形成缝隙后进行适当的加热时，所述膜以良好的均一性回缩(缩回)，从而形成穿过所述聚合物支架覆盖物的开口和在相邻支架元件之间形成柔性聚合物互连卷材。
由该方法得到的柔性互连卷材32通常在其末端具有较宽的宽度(所述卷材在该末端连接所述线顶点)，且在它们互连的顶点之间的长度中央具有较窄的宽度。另外，可存在膜的非常薄的残留边缘(36，图2B)，所述膜向外延伸离开所述笔直部分24中的线18，所述笔直部分24连接相同螺旋线圈中的顶点(即顶点22a和22b)。图5A描述了具有该边缘的线的横截面图(在图2B的平面图中所示的5部分截取)，其描述了所述边缘的一般外观，所述边缘位于施加到所述支架的外表面或内表面上的覆膜材料单层。图5B和5C描述了施加到所述支架元件的内表面和外表面上的覆盖物所显示的横截面图。
制造柔性支架的优选方法如下述。得到直径约等于想要的支架的内径的不锈钢芯轴。该芯轴表面具有1”宽
Figure BPA00001184252200081
聚酰亚胺膜带子(杜邦公司，0.002英寸厚)的螺旋包覆。提供由螺旋缠绕蛇形镍钛合金线制造的具有所需长度和直径的支架(线直径根据需要确定)。然后，缠绕所述芯轴的Kapton覆盖的表面。该支架线的末端使用具有固定结的FEP细线固定到相邻的支架线圈上。所述蛇形线的顶点对准，使得指向共同方向的顶点与所述芯轴的纵轴对准且平行。然后用FEP带单层覆盖物螺旋缠绕所述支架，所述FEP带由FEP膜切割而成(0.00015英寸厚和约0.75英寸宽)，在所述支架的外表面上拉紧，并使得FEP带的相邻边缘的重叠最少。该FEP带然后用前述类型的ePTFE膜卷烟式缠绕(在垂直于所述芯轴的纵轴方向上缠绕)。可通过使所述膜的横向边缘与所述芯轴的纵轴对准开始缠绕，并通过使用热源(例如清洁烙铁或合适的等同物)将ePTFE膜边缘仔细熔融粘结到FEP将其结合到下层的FEP膜上。六层ePTFE膜缠绕所述支架的外表面，膜的边缘沿着所述支架的长度(即平行于所述芯轴的纵轴)装点。用前面使用的热源固定所述膜的边缘。
在相邻的线顶点之间形成纵向缝隙41，如图4所示，它们指向相同的方向。这些缝隙可通过任意合适的方法形成，包括使用解剖刀刀片、喷水、激光等。一种合适的激光是本能公司(Coherent Inc.)生产的产品，型号：GEM-100A，CO2，CW(仅连续波)，美国加利福尼亚州的圣克拉拉市。如果需要使得末端排保持完全被覆盖(即以覆膜支架形式)的话，支架每个末端处的最后一排顶点可不形成缝隙。然后，在缠绕的支架的全部长度上提供其它临时的Kapton带螺旋缠绕物；该带的末端可用机械夹或其它临时固定装置固定到所述芯轴的表面上，超出所述支架的每个末端。该层Kapton接着用ePTFE带(由具有原纤微结构的ePTFE膜制成，且原纤维主要平行于所述带的长度取向，且以小的螺旋角缠绕，使得所述取向主要围绕所述芯轴)的临时螺旋缠绕物紧紧缠绕。当适当加热时，该ePTFE带向下层材料提供环向压缩。
上述构造体接着放入设定在380℃的合适对流烘箱中放置11分钟，然后从烘箱中拿出，并冷却到大约室温。然后除去ePEFE膜和Kapton带的外层。接着从所述芯轴上仔细除去所得的涂覆支架和下层Kapton带。然后，使用合适的工具(例如小镊子或钳子)从所述支架上除去剩余Kapton带子层。突出所述支架末端的剩余膜边缘可接着用解剖刀刀片在接近所述支架线末端顶点的横向上仔细修整。
图6A描述了球囊扩张支架60的透视图，它描述了下述的用球囊进行径向膨胀(diametrical expansion)，其优选如本文中所述使用。所示支架60包括环62，其中球囊扩张的支架元件形成多个菱形开口63d；支架60通常包括一个或多个这些环62。可使用本领域中已知的任何合适方法来构造这些单个环62，但是优选通过激光切割管来制造。为清楚起见，仅显示了最接近观察者的管状支架60的侧面。支架60具有聚合物覆盖物66，优选是柔性膜。覆盖物66如何通过卷材32互连多个环62形成支架60是明显的，所述卷材32横跨相邻环62的顶点22a和22b之间的距离。
尽管各种聚合物膜可用作用于该装置的支架覆盖物(或涂层)材料，但是优选是与ePTFE膜组合使用的FEP(氟化乙丙烯)的组合。用于该装置的优选ePTFE膜是在一个方向上具有更高强度的单轴膜，且该方向主要与球囊膨胀之前的支架纵轴61对准。该类型的膜类似于美国专利5476589中所公开的那些。另一种优选选择是通过施加不连续FEP涂层来改进所述膜，类似于美国专利6159565所公开的那些。
图6B描述了在所述环62在球囊膨胀之前显现时支架环62的布置，其没有聚合物覆盖物66。切割未膨胀的支架环62以具有开口63，该开口63在膨胀时变成菱形开口63d(如图6A所示)。支架环62彼此相邻放置，且顶点22a和22b呈典型的顶点-顶点对准。显然，相邻环62之间的距离可根据需要变化。
图6C描述了前述图6B中所示的支架环62，其加入了互连聚合物覆盖物66。显示卷材32(每个卷材都是聚合物覆盖物66的一部分)与环62互连相邻。图6D是图6C中所示支架60的上部左面端的放大细节示意图。
如图6C和6D所示，刺孔或缝隙68沿着支架60的纵轴在聚合物覆盖物66中排列。图6B-6D描述了形成在支架环62的相邻支架元件之间的多个开口63和64。穿过聚合物覆盖物66的缝隙68的尺寸和大小通常对应于每个支架环62中开口63和64的多样性(multiplicity)。这些缝隙68可通过前述各种方法形成。可穿过所述聚合物覆盖物66形成缝隙68，所述聚合物覆盖物66覆盖在相对顶点22a和22b之间延伸的开口63(封闭在每个支架环62之间的开口)。从每个支架环62的长度中央开始延伸并完全延伸到每个支架环62的末端的另一种开口64(即在径向相邻的顶点22a和22a之间，同样地在径向相邻的顶点22b和22b之间)也具有穿过所述覆盖物聚合物材料66的缝隙。这些缝隙68在相邻环62之间纵向延伸，且延伸入相邻环62中的对应开口。这些缝隙一起形成独立的互连卷材32。缝隙68的宽度可根据需要变化；相信解剖刀刀片的宽度是足够的，尽管附图中描述的缝隙68的宽度对应于下面的支架开口63和64的宽度。
如图6A所示，每个环62的顶点22a和22b可制造成相互指向，或者可以如图7所示相互偏离(即，如图7所示峰-谷对准，这与图1A-2D、图4和图6A中所示的峰-峰对准相反)。所述顶点通常“指向”基本上平行于管状支架60的纵轴61的方向。
图8是支架60安装在球囊(没有显示)上以随后展开和膨胀所显示的侧视图。支架60优选在安装过程中轴向压缩，使得互连卷材32弯曲或起皱，从而缩短所述支架60。以该种形式安装支架60的优点是在球囊膨胀过程中支架62缩短，因为它们会变形(开口63变成菱形开口63d)。例如，这使得缩短小于10％并得到大于6倍的径向膨胀成为可能。如果它们优选不向外突出的话，弯曲卷材32可在相邻支架环62下缩拢。优选的球囊(balloon)是从其长度中央向其相对末端径向膨胀的球囊。或者，在支架60的末端的环62可由比更接近支架60长度中央的环62更厚的材料制成。这些可替代方式可在膨胀过程中向弯曲的卷材32施加张力，从而将它们拉紧，增加它们的长度，以及补偿环62的缩短，以维持支架60的长度。
制造支架(例如图6A-7所示的支架)的优选方法如下述。标准菱形几何图形支架是激光加工的，且在激光技术公司(Laserage Tchnology Inc.，美国依利诺斯州沃基根市)由316LVM不锈钢管(4.19毫米直径×.38壁厚，购自诺曼诺贝尔公司(Norman Noble)，美国俄亥俄州克利夫兰市)进行电抛光。对所述支架进行表面粗糙化步骤，以提供附着，且没有降低耐疲劳性。在FEP粉末涂覆之前进行支架的等离子体处理，以清洁所述金属表面和降低金属表面的接触角。根据本领域中已知的常规方法进行等离子体处理。
通过首先用标准厨房型混合器将所述粉末搅拌成空降(airborne)“云”并将所述框架悬浮在所述云中直到均匀的粉末层附着到所述支架框架上来将FEP粉末(美国大金公司(Daikin America)，纽约州的桔堡市(Orangeburg))施加到所述支架组件上。所述支架组件接着于320℃热处理约3分钟。这使得所述粉末熔融，并作为涂层附着在所述支架组件上。每个环第二次涂覆，同时在相对末端将其悬浮，并放入320℃的烘箱中3分钟，然后取出，并冷却到室温。
如前述，十七层ePTFE薄层具有不连续的FEP涂层，然后缠绕不锈钢芯轴(约3.43毫米)。施加所述膜，且其高强度取向平行于支架的纵轴，且FEP侧朝外。单个支架环放在所述膜管上，并对准。在这种情况下，支架环以顶点-顶点对准，并在每个环之间均匀隔开约2.5毫米的缝隙，以得到约40毫米的整体装置长度。另一个相同的十七层膜如前述施加，不同的是FEP侧向下取向，朝着所述支架的外直径。
整个组合件用几层ePTFE细线(元件#S024T4，美国马里兰州埃尔克顿市(Elkton)的WL戈尔公司)缠绕，以向下层构造体施加压缩力。将组合件放入320℃烘箱(格力夫(Grieves)MT1000型，格力夫公司(Grieve Corporation)，美国依利诺斯州的圆湖(Round Lake)市)约40分钟。取出所述支架组合件，并冷却到室温。接着，除去外部(over-wrap)缠绕物，形成缝隙，且除去过量材料。
尽管已经描述和在本文中记载了本发明的具体实施方式，但是本发明并没有局限于这些描述和说明。显然，可以在下述权利要求书的范围对本发明作出改进和改变。

Claims (17)

1.一种制造柔性支架的方法，所述方法包括：a）提供在相对末端之间具有长度且具有支架元件的支架；b）使所述支架长度的至少一部分具有聚合物覆盖物；c）穿过相邻支架元件之间的覆盖物刺成缝隙或孔；
其中，所述方法的特征在于：d）加热所述支架和聚合物覆盖物以使所述缝隙或孔放大，形成了互连支架元件的聚合物卷材。
2.如权利要求1所述的方法，其特征在于，所述聚合物覆盖物包括ePTFE。
3.如权利要求1或2所述的方法，其特征在于，所述聚合物覆盖物包括氟化乙丙烯。
4.如权利要求1或2所述的方法，其特征在于，所述具有聚合物覆盖物的支架在刺穿之前进行加热，以将所述覆盖物粘结到所述支架元件上。
5.如以上权利要求任一项所述方法形成的支架，所述支架包括多排支架元件，每排所述支架元件具有顶点，其中一排的一个顶点通过一对聚合物卷材连接到相邻排的一对顶点上。
6.如权利要求5所述的支架，其特征在于，所述支架元件包括线。
7.如权利要求6所述的支架，其特征在于，所述线排的形式是螺旋缠绕线。
8.如权利要求5-7任一项所述的支架，其特征在于，所述聚合物包括ePTFE。
9.如权利要求8所述的支架，其特征在于，所述聚合物还包括氟化乙丙烯。
10.如权利要求5所述的支架，其特征在于，所述支架元件包括不锈钢或镍钛合金。
11.如权利要求5所述的支架，其特征在于，所述支架元件包括多个环。
12.如权利要求11所述的支架，其特征在于，所述环具有径向膨胀后穿过每个环的菱形开口。
13.如权利要求5所述的支架，其特征在于，所述支架是开放框架支架或者覆膜支架。
14.如权利要求5所述的支架，其特征在于，所述聚合物卷材熔融粘结到所述支架元件上。
15.如权利要求5所述的支架，其特征在于，所述支架具有长度，所述聚合物卷材沿所述长度是连续的。
16.如权利要求5所述的支架，其特征在于，所述卷材包括ePTFE。
17.如权利要求16所述的支架，其特征在于，所述卷材还包括氟化乙丙烯。
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