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CN102448406B - 支架 - Google Patents

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Publication number
CN102448406B
CN102448406B CN201080023374.5A CN201080023374A CN102448406B CN 102448406 B CN102448406 B CN 102448406B CN 201080023374 A CN201080023374 A CN 201080023374A CN 102448406 B CN102448406 B CN 102448406B
Authority
CN
China
Prior art keywords
coating
mentioned
support
stent
drug
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.)
Active
Application number
CN201080023374.5A
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English (en)
Other versions
CN102448406A (zh
Inventor
丸山和宏
斋藤昇
后藤大树
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.)
Terumo Corp
Original Assignee
Terumo Corp
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Filing date
Publication date
Application filed by Terumo Corp filed Critical Terumo Corp
Publication of CN102448406A publication Critical patent/CN102448406A/zh
Application granted granted Critical
Publication of CN102448406B publication Critical patent/CN102448406B/zh
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08—Materials for coatings
    • A61L31/10—Macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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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    • A61F2/89—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
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Abstract

本发明提供一种支架。该支架极力避免随着支架向放射方向扩张变形而在药剂涂层中产生应变或应力集中，且药剂不会脱落。使涂敷在支架主体(2)的外侧表面上的药剂涂层(4)的厚度(B)朝向弯曲部(K)逐渐减小，降低随着支架(1)的扩张变形而在药剂涂层(4)中产生应变或应力，避免药剂脱落。

Description

支架
技术领域
本申请基于2009年9月30日申请的日本特许申请编号2009-227417号，参照其公开内容并将其公开内容整体编入。
本发明涉及一种留置于在生物体内的管腔中产生的狭窄部或者闭塞部来维持管腔的开通状态的支架，特别是涉及一种在支架主体的外侧表面涂敷有药剂的被称作DES(Drug ElutingStent、药物洗脱支架)的药剂洗脱型的支架。
背景技术
支架是用于改善在血管、胆管、气管、食道、尿道等生物体内的管腔中产生的狭窄部或者闭塞部的医疗用具，一般是通过这样的方式形成的网眼状的圆筒体，即，使用较细的支承物，并将直状或者弯曲的线状部、U字状等的弯曲部在同一个平面上连续地形成为例如波状，在轴向上排列配置多个将该波状的支承物做成环状而成的波状环状体并将该多个波状环状体相互接合。
支架用于防止例如心脏的冠状动脉在经皮腔内冠状动脉成形术(PTCA)之后产生再狭窄，但通常认为使用未涂敷药剂的所谓的裸金属支架(bare metal stent)，预先将裸金属支架缩径并到达目标部位，并使裸金属支架扩张而留置在管腔内时，虽然与完全没有使用支架的仅进行PTCA的情况相比再狭窄率较低，但是会在支架留置部以约20％～30％的比例发生再狭窄。再狭窄的主要原因是由血管平滑肌细胞的迁移、增殖引起的内膜增生。
因而，最近正在开发一种在支架(也称作“支架主体”)的外表面涂敷能够抑制血管平滑肌细胞的迁移、增殖的药剂、在支架留置部位使药剂洗脱来防止再狭窄的DES。作为药剂，例如使用作为抗生素的西罗莫司(Sirolimus)或抗癌剂等。药剂的涂敷以下述方式进行，即，通过利用浸渍法、喷雾法或者所谓的直涂法(沿着构成支架主体的支承物涂敷)等将把药剂和生物体相容性聚合物溶解在溶剂中而成的涂敷液以存在规定量的药剂的方式存在于支架主体的表面，并将涂敷液干燥固化。
但是，为了将DES留置在管腔内，在将支架暂且做成缩径的状态地到达管腔内的目标部位之后，使支架扩张而留置，因此，产生涂敷在弯曲部等的药剂涂层随着支架(特别是弯曲部)的扩张变形而自支架主体的表面剥离、或者药剂自身被破坏而自支架主体脱落这样的问题。特别是在药剂涂层具有脆性的情况下，该问题非常显著。
因此，在WO03/009779A2(参照段落编号“0065”、“0066”等)中，公开有在支架的除弯曲部(“应变区域”或者“机械轮廓”)之外的部分以线状或点状形成药剂涂层、或者在弯曲部以点状形成药剂涂层。
但是，这样以点状形成药剂涂层的方式恐怕药剂在量上不充分，并不理想。另外，即使是在除弯曲部之外的部分以线状形成有药剂涂层的支架，也恐怕由扩张引起的变形的起点与药剂涂层的端部一致、或者根据情况在形成有药剂涂层的部分存在变形的起点，有可能在药剂涂层中产生应变或应力集中，药剂自支架主体的表面剥离，该剥离传播到其周边而破坏药剂涂层，导致较大的脱落。即，在支架向放射方向扩张的情况下，扩张的大小等并不恒定，扩张的大小针对每个手技都不相同，从而，一律地对除弯曲部之外的部分进行涂敷，而不在也考虑到扩张的弯曲部的哪个位置成为变形的起点的基础上来涂敷药剂，若变形的起点和药剂涂层的端部一致，则会在药剂涂层中产生应变或应力集中，发生药剂的剥离、破损、脱落。
发明内容
本发明即是为了解决上述课题而做成的，其目的在于提供一种极力避免随着支架向放射方向扩张变形而在药剂涂层中产生应变或应力集中、没有药剂脱落、使用便利性较佳的支架。
达到上述目的的本发明的支架的特征在于，使涂敷在支架主体的外侧表面上的药剂涂层的厚度朝向弯曲部逐渐减小，大幅度降低随着支架的扩张变形而在药剂涂层中产生应变或应力集中，并且，药剂涂层自身也能够随着支架的变形容易地变形，在两者的相互作用下防止药剂脱落。
在技术方案1的发明中，由于形成有使药剂涂层的厚度朝向弯曲部逐渐减小的渐减部，因此，即使随着支架的扩张而变形的起点自支承物的弯曲部偏移一些，存在于变形的起点及其附近上的药剂涂层也会变薄。因而，能够大幅度降低在药剂涂层中产生应变或应力集中，防止药剂脱落。
而且，由于渐减部的药剂的涂敷量较少，因此，药剂自身也易于追随支架的变形，在这一点上也能够防止药剂脱落。
特别是，形成为由于不使用可塑剂等添加物就能够防止药剂脱落的结构，因此，不会对生物体产生不良影响，安全性较高。
在技术方案2的发明中，由于将以利用弯曲部的扩张而变形的起点(弯曲点)为中心的规定范围做成无涂层，因此，通过不在最易于发生应变或应力集中的部分涂敷药剂，成为具有下述优点的支架，该支架能够抑制药剂脱落，能够容易地应对支架在留置部位处的各种扩张状态，容易处理，手技也容易且可靠，使用便利性极佳。
在技术方案3的发明中，由于在以上述弯曲部的弯曲点为中心的规定范围内形成有药剂的薄膜涂层，因此，抑制药剂脱落并易于定量地确保药剂。
在技术方案4的发明中，由于利用药剂和聚合物的混合物形成上述药剂涂层，因此，易于对支承物的外表面进行涂敷作业，作业性也提高。
在技术方案5～6的发明中，由于上述聚合物使用生物降解性聚合物、例如乳酸和二醇酸的共聚体、聚乳酸、聚二醇酸，因此，在生物体内留置支架之后，覆盖并保护药剂的聚合物被生物降解，药剂被慢慢释放，能够可靠地防止支架留置部的再狭窄。
在技术方案7的发明中，由于在上述支架主体和药剂涂层之间设有底涂层，因此，成为支架主体和药剂的结合良好的、剥离性较少的支架。
在技术方案8的发明中，由于使上述渐减部的倾斜角为1度～45度，因此，能够容易地形成或者制造即便使支架扩张变形也难以在药剂涂层中发生应变或应力集中的支架。
在技术方案9的发明中，通过将由具有弯曲部的波状的支承物形成的波形环状体在轴向上排列配置多个并将波形环状体相互接合，来将上述支架主体形成为圆筒状，因此，能够通过连结波形环状体而得到规定长度的支架，不仅在制造支架主体的方面，而且在制造DES的方面也变得容易。
在技术方案10的发明中，在自喷嘴喷出涂敷液并沿着支承物移动而形成层叠的多层薄膜涂层时，使上层的薄膜涂层的涂敷长度小于下层的薄膜涂层的涂敷长度，使上述渐减部成为阶梯状，因此，能够简单地形成上述渐减部。
在技术方案11的发明中，在该上述渐减部的形成过程中，使上述喷嘴在上述弯曲部从支承物的一方朝向另一方地移动，因此，能够迅速地形成或者制造渐减部。
在技术方案12的发明中，由于使用喷雾法或者喷墨法形成上述药剂涂层，因此，能够容易且迅速地形成药剂涂层。特别是，在使用喷墨法形成的情况下，能够药剂损失较少且高精度地形成药剂涂层。
通过参考以下的说明及附图所例示的优选实施方式，应能明确本发明的其他目的、特征及特质。
附图说明
图1是表示本发明的一个实施方式的概略主视图。
图2是表示该实施方式的使用状态的概略主视图。
图3是缩径状态的支架的放大俯视图。
图4是扩张状态的支架的放大俯视图。
图5是弯曲部的放大俯视图。
图6是沿着图5中的6-6的概略剖视图。
图7是涂敷装置的概略主视图。
图8是沿着图7中的8-8的概略剖视图。
图9是芯棒部分的剖视图。
图10是涂敷方法的流程图。
图11是接着图10的涂敷方法的流程图。
具体实施方式
下面，参照附图详细说明本发明的实施方式。
首先，概略说明支架，如图1所示，其包括由较细的支承物3形成的例如做成网眼状的圆筒状的支架主体2、及涂敷在支架主体2的表面的药剂涂层4(参照图6)。
支架1使用例如图2所示的支架输送系统留置在血管等的内部。支架输送系统10包括：轴主体部13，其为由同心地配置的内管11和外管12构成的双重管构造；球囊14，其设置在轴主体部13的前端部且能够折叠和扩张；分支轴套16，其具有用于注入球囊扩张用流体的注射口15。
为了使用该系统10将支架1留置在血管内，首先，以内包折叠状态的球囊14的方式使支架1缩径而安装在上述系统10上，之后向前端开放的内管11的内部贯穿导丝，将导丝作为引导件而将安装有支架1的上述系统10引导到血管内的规定位置。然后，从注射口15注入流体，使流体通过内管11和外管12之间的管腔流入至球囊14而将球囊14扩张。当安装在此的支架1从内部向放射方向外方扩张时，支架1向放射方向和/或轴向伸长而塑性变形，以扩张的状态留置在血管内。
更详细地说明本实施方式的支架1。如图1、图3所示，本实施方式的支架主体2将由张开角α较小的U字状的弯曲部K1、张开角α较大的V字状的弯曲部K2、由直状部或弯曲部构成的线状部S交替配置而成的结构做成环状来形成波状环状体C(也称作“单元部分C”)。各单元部分C的轴线方向长度为“L1”。而且，通过利用接合部F将一个单元部分C中的呈U字状的弯曲部K1的前端和相邻的单元部分C的呈U字状的弯曲部K1的基端连续地接合起来，从而做成将多个单元部分C连结而成的、轴线方向长度为“L2”的、整体例如做成网眼状的圆筒体。另外，在图1所示的结构中，由14个单元部分C构成。
支架主体2自图3所示的收缩状态被向放射方向推开而展开时，如图4所示，张开角α变大，构成弯曲部K1或弯曲部K2的支承物3相互远离，成为空隙部O较大地扩展的扩开状态。
支架主体2的弯曲部K1、K2不优选弯曲的部分弯折成锐角，优选以U字状或者平缓的圆弧状弯折或者弯曲。由此，也能够减少产生在扩开时对后述的药剂涂层4施加的应变，抑制药剂涂层4的剥离、破坏、破损或者脱落的效果较高。但是，弯曲端部的弯曲形状优选如图3所示地弯曲成不会朝向外方较大地鼓起的程度、即弯曲端部不会以圆弧状向外方鼓出的程度。由此，能够减小缩径时的外径，也有利于支架向细径的生物体内器官(例如血管)中插入。
作为支架主体2的形状材料，优选具有生物体相容性的材料，例如优选为不锈钢、钽或者钽合金、铂或者铂合金、金或者金合金、钴基底合金、钴铬合金、钛合金、铌合金等。而且，作为不锈钢，最优选具有耐腐蚀性的SUS316L。
支架主体2优选为安装在球囊14上的状态的支承物3所占的面积是包含空隙部O的整个外周面的面积的60％～80％。
作为支承物3的宽度，优选为40μm～150μm，特别优选为80μm～120μm。作为各单元部分C的轴线方向长度L1，优选为0.5mm～2.0mm，特别优选为0.9mm～1.5mm。支架主体2的非扩张时的直径D1优选为0.8mm～2.5mm，特别优选为0.9mm～2.0mm。非扩张时的长度L2优选为8mm～40mm左右。
支架主体2的成形是通过自管体(具体地讲是金属管)除去除支承物之外的部分而形成规定的图案来进行的。例如通过利用被称作金属表面光刻法(Photofabrication)的使用掩模和化学药品进行的蚀刻方法、利用模具进行的放电加工法、切削加工法(例如机械研磨、激光切削加工)等自金属管除去空隙部O来进行支架主体2的成形。
在这样成形之后，利用化学研磨或者电解研磨除去支承物3的边缘，精加工成平滑的面。
并且，也可以在成形为规定的图案之后进行退火。利用退火，整个支架的柔软性和挠性上升，支架在弯曲的血管内的留置性变得良好，对血管内壁施加的物理刺激也减少，能够减少再狭窄的诱因。为了不在支架表面形成氧化被膜，退火优选通过在不活性气体气氛下(例如氮和氢的混合气体)加热到900℃～1200℃之后慢慢地冷却来进行。
药剂涂层4的形成例如能够使用浸渍法、喷雾法、喷墨法、喷嘴喷射法等各种方法，但在本发明中优选喷雾法、喷墨法、喷嘴喷射法。
在此，喷雾法是指将药剂与空气流一同喷射到支架主体2的外侧表面来形成药剂涂层4，喷墨法是指将药剂做成微细颗粒而涂敷到支架主体2的外表面，喷嘴喷射法是指将药剂自喷嘴涂敷到支架主体2的外表面。
在使用喷雾法或喷墨法时，能够容易且迅速地形成药剂涂层，而且，在使用喷墨法或喷嘴喷射法时，能够药剂损失较少且高精度地形成药剂涂层。
喷雾法、喷墨法、喷嘴喷射法基本上仅是将药剂涂敷在支架主体2的外表面的工艺不同，形成的药剂涂层4的构造相同，因此，下面对使用喷嘴喷射法来形成药剂涂层4的情况进行说明。
图5是弯曲部的放大俯视图，图6是沿着图5中的6-6的概略剖视图。在本实施方式中，在上述支架主体2的外侧表面形成图5、图6所示那样的药剂涂层4。在本实施方式中，使用沿着支承物3直接涂敷多次涂敷液的层叠法，形成为药剂涂层4的厚度B朝向弯曲部K渐减。而且，优选在支架主体2和药剂涂层4之间设置底涂层5。由于底涂层5由具有与构成后述的药剂涂层的聚合物的粘接性的材料构成，因此，支架主体2和药剂的结合良好，成为剥离性较少的支架。
本实施方式的药剂涂层4如图5所示地以如下方式形成有渐减部6，即，支架主体2的由直状部或弯曲部等构成的线状部S的厚度B大致均匀，但从线状部S到弯曲部K的厚度B逐渐减小，在弯曲点P及其附近成为未涂敷药剂的无涂层或者极薄的药剂涂层。
即，在使用下述的层叠法形成规定厚度B的药剂涂层4时，只要喷嘴随着接近弯曲点P及其附近而调整各薄膜涂层4a的涂敷区域，阶梯性地减少薄膜涂层4a的层叠数，就能够容易地逐渐减小药剂涂层的厚度B，从而能够形成以弯曲点P及其附近为中心的谷状的渐减部6。上述层叠法是使喷嘴沿着支架主体2的规定图案移动、并向支架主体2的表面喷出药剂而形成多层较薄的厚度b的薄膜涂层4a的方法。另外，之后详细说明薄膜涂层4a的形成。
若这样使药剂涂层4的厚度B朝向弯曲部K及其附近逐渐减小，则在将支架1向放射方向扩张时，即使支架主体2发生变形的起点自弯曲部K的弯曲点P偏移一些，由于存在于变形的起点及其附近的药剂涂层4的厚度较薄，因此，也会大幅度减少在药剂涂层4中产生应变或应力集中。
即，支架主体2中的弯曲点P的位置在几何学上是弯曲部K中的所谓的拐点，但实际上使用球囊等自支架的内部施加扩张力而使支架1向放射方向扩张时，支架主体2的弯曲部K发生变形的起点并非总是拐点，而是根据对支承物3施加的扩张力的作用方向等而变化，无法唯一确定。但是，若形成药剂涂层4的渐减部6，使药剂涂层4的厚度B朝向弯曲部K及其附近逐渐减小，则即使支架主体2中的弯曲点P的位置变化一些，药剂涂层4也会追随支架主体2地变形，在药剂涂层4中产生的应变或应力集中极小。而且，由于该部分的药剂涂敷量较少，因此，药剂自身也易于追随支架主体2的变形。结果，在两者的相互作用下大幅提高防止药剂脱落的效果。
另外，关于弯曲点P，如上所述并不是明确地确定的，因此，在图5中以虚线表示有可能存在弯曲点P的区域。
在将弯曲部K作为直状表示的图6中，表示渐减部6的具体例子，1层薄膜涂层4a的厚度b优选为1μm～5μm，薄膜涂层4a的层数优选为1层～50层，弯曲部K的长度X优选为50μm～1000μm，上下的薄膜涂层4a的端部之间的长度Y(其中也存在各端部之间的长度不均等的情况)优选为1μm～1000μm。而且，渐减部6的倾斜角θ小于90度，优选为1度～60度，更优选为1度～45度。在倾斜角θ小于1度的情况下，虽然能在较宽范围内发挥抑制药剂的脱落的效果，但是涂敷的药剂量有可能减少，并不优选，相反，在倾斜角θ大于60度的情况下，抑制药剂的脱落的效果有可能降低，因此并不优选。而且，倾斜角θ为1度～45度的形态容易利用后述的层叠法制造。
上述的例子是将以弯曲点P为中心的50μm～1000μm的范围做成未形成有药剂涂层4的无涂层的情况，在该无涂层的情况下，在应变最易于集中的部分未涂敷药剂，因此，成为药剂脱落抑制能力较高的支架，即使在支架的留置部位发生例如必须较大地扩张的状况，也能够容易地应对该状况，支架的处理较容易，手技也容易且可靠，成为使用便利性极佳的支架。
但是，本发明并不必仅限定于无涂层，弯曲部K也可以具有1层～几层薄膜涂层4a。
药剂涂层4由药剂和聚合物的混合物构成。该混合物更优选由药剂和生物降解性聚合物的混合物构成。在生物体内留置支架之后，当覆盖并保护药剂的聚合物生物降解时，药剂渐渐释放，能够可靠地防止支架留置部的再狭窄。作为生物降解性聚合物优选使用乳酸和二醇酸的共聚体、聚乳酸、聚二醇酸中的任一种。
药剂涂层4的各薄膜涂层4a的药剂和聚合物的混合比可以相同，也可以不同。例如也可以使药剂相对于聚合物的比例从与底涂层5接触的最下层的薄膜涂层4a朝向上层薄膜涂层4a逐渐升高。
图7是涂敷装置的概略主视图，图8是沿着图7中的8-8的概略剖视图，图9是芯棒部分的剖视图。
作为利用层叠法在支承物上形成薄膜涂层4a的涂敷装置，使用例如图7、图8所示的装置。在涂敷装置20中，通过由透明的合成树脂板(未图示)从外表面覆盖被竖立设置在基台21上的框架22，在其内部形成具有气密性的腔室23。在腔室23中，在顶部连结有管道24，自空调机25供给被控制了温度和湿度的空气，使腔室内成为恒温恒湿的状态，将在支架主体2上涂敷后述的涂敷材料W时的干燥固化条件始终保持恒定。
在腔室23内的下部设有用于保持支架主体2的保持器具30、及用于使保持器具30移动的移动部件40，在腔室23内的中间部，在横架于框架22的支承框架26上安装有用于将涂敷材料W涂敷在支架主体2的支承物3上的涂敷头50、用于获取支架主体2的表面、即支承物3的表面在正交坐标系中的X-Y方向的位置信息的第1位置信息获取部件60、及用于获取该正交坐标系中的Z方向的位置信息的第2位置信息获取部件70。
另一方面，在腔室23的外部设有控制部80，用于控制保持器具30、移动部件40、涂敷头50和两位置信息获取部件60、70。
如图8所示，保持器具30的结构如下，即，芯棒34的基端夹持在连结于能够正反旋转的电动机M2的卡盘部33上，支架主体2能够装卸地设置在芯棒34的外周。
电动机M2载置在滑动部32上，滑动部32能够移动地(沿Y方向)设置在基板31上，基板31载置在移动台42上，该移动台42沿着作为所谓的线性电动机式的驱动源的行进轨道41移动(沿X方向)。由此，保持器具30能够使支架主体2正反旋转、沿X方向、Y方向移动。
芯棒34的外径优选与支架主体2的内径大致相同或者比支架主体2的内径大一些，但芯棒34能够根据支架主体2的内径更换，准备了具有多种外径的芯棒34。芯棒34均为了吸收光而以黑色涂料涂装，提高了装配的支架主体2的支承物3与空间部O的对比度。另外，如图9所示，芯棒34在其外周面形成有凹部35，在将支架主体2安装在芯棒34上时，在芯棒34的外周面和支架主体2的支承物3的下表面3a之间产生间隙G，防止将涂敷材料W涂敷在支承物3上时涂敷材料W蔓延到芯棒34的表面和支架主体2的内侧表面之间，谋求形成均匀的涂层、作业的便利性。
如图7、图8所示，涂敷头50借助例如垂直台(未图示)装配在安装于支承框架26的托架51上，该垂直台利用由电动机M 3驱动的丝杠进给机构等沿Z方向移动，该涂敷头50具有用于慢慢喷出储存在内部的涂敷材料W的分配器53、和用于喷出涂敷材料W的喷嘴部54。
如图8所示，分配器53是注射器工作机构，其具有在内部储存有涂敷材料W的筒体(cylinder)部55、能够滑动地设置在筒体部55内的活塞部56、及利用规定的力F按压活塞部56的电动机或者液压机构等驱动部(未图示)。
喷嘴部54由设置在筒体部55的下端的安装构件57、及自安装构件57垂下的喷嘴58构成，从筒体部55到喷嘴58形成有供涂敷材料W流通的流路(未图示)。
喷嘴58的顶端外径为10μm～1000μm，为了将具有后述粘度的涂敷材料W以规定的喷出速度挤出，喷嘴58的顶端内径为1μm～500μm，优选为5μm～250μm。在其顶端内径小于5μm的情况下，涂敷材料W无法顺畅地流出，且喷出涂敷材料W需要很大的压力。另外，在其顶端内径大于250μm的情况下，有可能实质上无法在现今使用的支架主体2上顺畅地涂覆涂敷材料W。
另外，为了防止喷出的涂敷材料W附着，喷嘴58优选研磨为尽可能地减小表面的凹凸，例如优选使用不锈钢、碳钢、镍、钛、铬、玻璃、铝氧化物、锆氧化物、金刚石、或者将它们复合而成的材料等。
分配器53设置为，以喷嘴58和支承物3的间隔N为规定长度的方式自支承物3离开，将涂敷材料W从喷嘴58朝向支承物3的表面不间断地连续挤出而使涂敷材料W载置在支承物3的表面上。采用该连续挤出方式，能够将涂敷材料W均匀地涂敷在支架主体2的目标部分，而且能够定量地喷出，因此，控制性也较佳，也能够高精度且可靠地调整治疗物质的量。而且，在调整为恒温、恒湿的腔室内，使涂敷材料W干燥固化的条件恒定，因此，能够容易且迅速地制造附着有涂敷材料W的支架1。
自喷嘴58喷出的涂敷材料W的粘度为0.1cp～10cp，优选为1.0cp～4.0cp。在粘度高于上述范围时，存在喷出需要很大的压力、或者无法自较细的喷嘴58喷出的情况，在粘度低于上述范围时，也有可能喷出的涂敷材料W自支承物3泄漏，无法形成均匀的涂覆层。
喷嘴58和支承物3的间隔N为0.1μm～200μm，优选为1μm～100μm。在间隔N大于上述范围时，存在涂敷材料W中断这样的问题，在间隔N小于上述范围时，存在涂敷材料W自支承物表面泄漏这样的问题。
如图7所示，第1位置信息获取部件60是借助托架(未图示)位置固定地安装在支承框架26上的摄像部件，具有照相机部62和以沿支架主体2的轴向延伸的方式配置的线传感器(linesensor)部(未图示)，第1位置信息获取部件60与保持器具30上的支架主体2的旋转同步地扫描支架主体2的表面，获取支架主体2表面的图像，传送到控制部80。如上所述，芯棒34为了提高装配的支架主体2的支承物3与空间部O的对比度而以黑色涂料涂装，能够吸收光，因此，在获得的支架表面的图像中，支承物3的亮度较高，空间部O的亮度较低。因此，控制部80通过以适当的亮度将获取的支架主体2的表面图像二值化而区分为支承物3和空间部O，能够作为支承物3的坐标、即支承物3在X-Y方向上的位置信息。并且，控制部80根据获得的X-Y方向的位置信息(支承物3的X-Y坐标)计算出通过支承物3中心的轨道的坐标，获得的中心轨道的数据被保存在控制部80的存储器中。在涂敷涂敷材料W时，不使涂敷材料W自支承物3脱落地进行涂敷非常重要，为此，确定支承物3的中心也极为重要。
如图7所示，第2位置信息获取部件70由被称作所谓的垂直传感器(vertical sensor)的激光变位传感器73构成，该激光变位传感器73为Z方向的变位测定部件，用于测定支承物3的Z方向变位，且该激光变位传感器73位置固定地安装在被安装于支承框架26的托架71的下端。
支承物3严格地讲表面并不平滑，而是具有凹凸，为了在该具有凹凸的支承物上定量且精密地涂敷涂敷材料W，必须使喷嘴58的顶端严格地与支承物3的表面平行地移动，涂敷规定量的涂敷材料W。因而，利用激光变位传感器73从支架主体2的规定位置、例如涂敷开始点处的支承物3的位置信息开始获取位置信息，在使支架主体2正反旋转的同时沿着通过支承物3的中心的轨道扫描，收集整个支架主体2的Z方向变位数据，将获取的变位数据保存在控制部80的存储器中。
控制部80虽未图示，但具有处理器、监视器、键盘等，由上述各种位置信息决定涂敷涂敷材料W的涂敷方式的设定、涂敷头50在支架主体2的支承物3上涂敷涂敷材料W的涂敷路径。另外，控制保持器具30的芯棒34的旋转、移动部件40的移动及自涂敷头50喷出的涂敷材料W的喷出量、摄像部件或垂直传感器的扫描等。
涂敷方式是指沿着支承物3涂覆的情况下的涂敷路线。涂敷路线优选为能够没有重复涂覆的区间地连续涂敷整个支承物3的路线，但在支承物3复杂地交叉的支架1中，也存在不容易设定没有重复涂敷的区间的路线的情况。在这种情况下，设置重复涂敷的区间、或者设置从支承物3上的某一点向另一点跳跃的区间。通过这样在一部分设置重复的区间或跳跃的区间，能够缩短涂敷路线。另外，通过使在重复的区间(通过多次的区间)通过的移动速度比在通过一次的区间通过的移动速度快，能够在支架主体2的目标部分均匀地涂敷药剂，从而能够充分地发挥降低PTCA等情况下的再狭窄率的效果。特别是，在以像本实施方式这样形成随着接近弯曲部K而厚度逐渐减小的渐减部6的方式进行涂敷的情况下，优选使喷嘴58从支承物3的形成弯曲部K的一部分朝向形成弯曲部K的与该一部分相对的另一部分移动。由此，能够迅速地形成渐减部6。
在决定涂敷路径时，优选采取下述的各种对策。
(1)在支架主体2的支承物3上涂敷涂敷材料W的情况下，在支承物3的线状部S中，优选将通过支承物3中心的轨道作为涂敷路径。但是，在支承物3的弯曲部K中，优选将通过在支承物3的宽度方向上偏移规定量的位置的轨道作为涂敷路径。涂敷材料W是液体，以利用表面张力隆起的状态存在于支承物3的表面上，即使涂敷材料W干燥固化，也容易成为截面呈圆弧状的涂层。从而，在涂敷多次的情况下，有以圆弧状隆起的倾向，因此优选如下方式，即，将通过自支承物3的第1次的涂层偏移规定量的位置的轨道作为涂敷路径来形成第2次的涂层，第3次的涂层将通过与第1次涂敷路径和第2次涂敷路径不同的位置的轨道作为涂敷路径。
(2)在决定涂敷路径时，优选使涂敷路径在线状部S和弯曲部K中不同。在线状部S中，如上所述那样将通过支承物3的宽度方向中心的轨道作为涂敷路径即可，但若在弯曲部K中将通过支承物3的宽度方向中心的轨道作为涂敷路径，则从涂敷头50喷出的涂敷材料W会被其粘性、自喷嘴的落下速度等影响，不会沿着涂敷头50的移动轨道地追随。因而，优选将通过支承物3的弯曲部K的中心的线的外侧设定为涂敷路径。
(3)在支承物3的交叉部中，优选将上述多个支承物3的中心轴线的交点或者交点的附近作为涂敷路径。在支承物3交叉的部分中，涂敷路径P也会交叉，因此，只要将支承物3的中心轴线的交点或者交点的附近作为涂敷路径，就能够防止涂敷材料W滴落，较为理想。
接着，说明涂敷方法。图10是涂敷方法的流程图，图11是接着图10的涂敷方法的流程图。
准备工序
首先，在开始涂敷时，使空调机25工作，使腔室23内成为恒温恒湿的状态。而且，将注射器工作机构53设置在支承框架26上，该注射器工作机构53是将具有与支承物3的宽度、涂敷材料W相对应的内径的喷嘴58的喷嘴部54、及注入有涂敷材料W的筒体部55等组合而形成的。
另一方面，在将支架主体2安装在芯棒34上之后，将它们安装在处于待机位置的保持器具30的卡盘部33上，设定为支承物3的涂敷开始点位于芯棒34的凹部35之上。另外，如图7所示，在腔室23的下部具有移动部件40的情况下，待机位置是腔室23的入口部23A的附近。
摄像工序
控制部80接受摄像参数的输入，将所输入的摄像参数存储在存储装置中(S1)。摄像参数由操作人员例如从键盘输入。摄像参数包含芯棒34的转速、摄影线路(line)数量、摄影线路宽度、摄影时动作速度。
控制部80在存储被输入的摄像参数之后命令开始摄像。同时，使X方向移动部件40x工作(S2)。由此，保持器具30从待机位置沿着行进轨道41移动到第1位置信息获取部件60之下。控制部80确认保持器具30到达规定位置的情况(S3)，若保持器具30到达规定位置，则使保持器具30的电动机M2工作，使支架1开始旋转(S4)。
另一方面，在收到摄像开始的命令之后，第1位置信息获取部件60的线传感器开始拍摄，扫描支架主体2的表面，拍摄表面图案(S5)。拍摄到的图像作为平面展开图像存储在控制部80内的存储装置(例如存储器或硬盘等)中。也可以将图像输出到监视器中，使得能够利用肉眼确认。
在支架主体2的表面图像中，支承物3的亮度较高，空间部O的亮度较低，因此，控制部80将某一亮度作为边界而转换为黑白的二值化图像(S6)，利用支承物3的宽度的细线化处理计算出通过支承物3中心的轨道的坐标(S7)。
涂敷方式的设定工序
由获取的支架主体2的表面图像进行判断，考察位置和是否需要重复涂敷的区间及跳跃的区间，涂敷支承物3的目标表面部分，以重复涂敷的区间及跳跃的区间尽量地少或短的方式设定涂敷路线。
Z方向的变位测定工序
接着，控制部80接受作为Z方向的变位测定部件的第2位置信息获取部件70的变位测定参数的输入并存储该变位测定参数(S9)。该变位测定参数也由操作人员输入。变位测定参数包含测定开始位置、测定的方向、分支点处的方向、测定速度、测定间隔。
控制部80在存储变位测定参数之后，使Y方向移动部件40y的电动机M1工作(S10)。必要的话，一边利用摄像机和监视器观察，一边调整支架主体2和变位测定部件的测定位置，使得上述变位测定部件的测定位置和轨道上的指定位置一致(S11)。
在通过调整使测定位置和指定位置一致时(另外，一致的状况由操作人员输入到控制部80中(S12：Yes))，控制部80对第2位置信息获取部件70命令开始测定支承物3的Z方向变位(S13)。同时，控制部80使利用电动机M2进行的正反旋转以及利用电动机M1进行轴向移动反复进行。由此，支架主体2反复进行旋转以及轴向移动(S14)。
由此，第2位置信息获取部件70沿着通过支承物3的中心的轨道移动，因此，控制部80收集Z方向的变位数据(S15)。该变位数据与中心轨道的坐标一同保存在控制部80的存储装置中。
涂敷工序
控制部80接受涂敷参数的输入并将所输入的涂敷参数存储(S16)。涂敷参数也由操作人员输入。涂敷参数包含涂敷开始位置、涂敷的方向、交叉点处的方向、轨道调整区间的设定、轨道的调整量、涂敷速度、涂敷材料W的喷出速度、涂敷头的高度、涂敷次数(层数)、涂敷头的选择。
控制部80在存储涂敷参数之后命令开始涂敷。同时，发出利用X方向移动部件40x而使保持器具30移动的命令(S17)。由此，使支架主体2移动至涂敷头50之下的涂敷开始位置(S18)。在支架主体2到达涂敷头50之下的涂敷开始位置之后(S19：Yes)，发出利用电动机M2进行的正反旋转以及利用电动机M1进行的轴向移动的命令，通过利用电动机M2进行的正反旋转并利用电动机M1进行的轴向移动，使支架主体2遵照指定的参数沿x轴方向和y轴方向移动(S20)。同时，使涂敷头50遵照指定的参数而利用电动机M3沿Z轴方向移动(S21)。此时，自涂敷头50连续地喷出涂敷材料W。由此，涂敷头50在沿着预先决定的涂敷路径移动的同时涂敷涂敷材料W。
在涂敷过程中，喷嘴58的顶端和支架主体2之间成为充满涂敷材料W的状态，因此，能够定量喷出涂敷材料W，也能够可靠地将支架主体2上的药剂量设定为规定值。而且，也不会在支承物3之间产生片状物或桥，能够极高精度地形成药剂涂层4。
在涂敷结束时，保持器具30利用X方向移动部件40x移动至待机位置，将芯棒34自保持器具30拆下并取出到腔室23之外，将形成有药剂涂层4的支架主体2自芯棒34拆下。
本发明并不仅限定于上述实施方式，能够在本发明的技术思想内由本领域技术人员进行各种变更。例如在上述实施方式中，列举出药剂涂层的厚度B朝向弯曲部K或其附近呈直线变化的渐减部6，但本发明的渐减部6的形状不只是这样，只要药剂涂层的厚度B在弯曲部K及其附近变薄即可，也可以做成圆弧状等各种形状。
另外，涂敷材料W也可以不只是1种而是多种。在涂敷多种涂敷材料W的情况下，准备多个注射器、喷嘴及注射器工作机构，依次切换地涂敷。这些注射器工作机构等的依次切换利用控制部80来控制。在此，不同的涂敷材料W是指聚合物不同或聚合物相同但其量不同、或者药剂不同或药剂相同但其量不同、或者溶剂不同的情况。若这样地使用多种涂敷材料，则药效也是复合性的，能够减轻患者的肉体及精神上的痛苦等，对患者来说极为有利。
而且，形成药剂涂层4的方法也并不仅限定于上述实施方式，例如也可以使用喷雾法或喷墨法。
并且，上述实施方式是具有做成波形的规定图案的支架，但并不仅限定于这种支架，只要是具有弯曲部K的支架，就也可以具有其他图案的支架。
产业上的可利用性
本发明能够用作大幅度降低经皮腔内冠状动脉成形术(PTCA)之后的再狭窄率的支架。

Claims (12)

1.一种支架，该支架包括由具有弯曲部的波状的支承物形成的圆筒状的支架主体、及通过在该支架主体的外侧表面涂敷药剂而形成的药剂涂层，随着上述支架主体向放射方向扩张或收缩，至少上述弯曲部扩张变形或收缩变形，其特征在于，
上述药剂涂层具有通过使该药剂涂层的厚度从所述波状的支承物的线状部朝向上述弯曲部逐渐减小而形成的渐减部。
2.根据权利要求1所述的支架，其特征在于，
上述弯曲部使以弯曲点为中心的规定范围成为未形成有上述药剂涂层的无涂层。
3.根据权利要求1所述的支架，其特征在于，
上述弯曲部在以弯曲点为中心的规定范围内形成有上述药剂的薄膜涂层。
4.根据权利要求1～3中任一项所述的支架，其特征在于，
上述药剂涂层由上述药剂和聚合物的混合物形成。
5.根据权利要求4所述的支架，其特征在于，
上述聚合物是生物降解性聚合物。
6.根据权利要求5所述的支架，其特征在于，
上述生物降解性聚合物是乳酸和二醇酸的共聚体、聚乳酸、聚二醇酸中的任一种。
7.根据权利要求1所述的支架，其特征在于，
在上述支架主体和上述药剂涂层之间设有底涂层。
8.根据权利要求1所述的支架，其特征在于，
上述渐减部的倾斜角为1度～45度。
9.根据权利要求1所述的支架，其特征在于，
通过由具有上述弯曲部的波状的支承物形成波形环状体，将该波形环状体在轴向上排列配置多个并将该波形环状体相互接合，从而将上述支架主体形成为圆筒状。
10.根据权利要求1所述的支架，其特征在于，
通过层叠多层薄膜涂层来形成上述药剂涂层，该薄膜涂层通过自喷嘴部喷出将药剂和聚合物溶解在溶剂中而成的涂敷液、并使该喷嘴部沿着上述支承物移动而形成，使上述多层中的上层的薄膜涂层的涂敷长度小于下层的薄膜涂层的涂敷长度，使上述渐减部成为阶梯状。
11.根据权利要求10所述的支架，其特征在于，
通过使上述喷嘴部在到达上述弯曲部或者该弯曲部附近时、从上述支承物的形成该弯曲部的一部分朝向形成该弯曲部的与该一部分相对的另一部分移动，从而使上述药剂涂层形成上述渐减部。
12.根据权利要求1所述的支架，其特征在于，
上述药剂涂层使用喷雾法或者喷墨法来形成。
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EP2444034A1 (en) 2012-04-25
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US9737423B2 (en) 2017-08-22
ES2638548T3 (es) 2017-10-23
WO2011040218A1 (ja) 2011-04-07
AU2010301898B2 (en) 2015-10-22
CN102448406A (zh) 2012-05-09
AU2010301898A1 (en) 2012-01-19
US9095459B2 (en) 2015-08-04
CA2767994A1 (en) 2011-04-07
KR101687436B1 (ko) 2016-12-19
CA2767994C (en) 2017-07-04
JP5570515B2 (ja) 2014-08-13
US20150265440A1 (en) 2015-09-24
BR112012007578A2 (pt) 2020-08-11
US20120165923A1 (en) 2012-06-28
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BR112012007578B1 (pt) 2021-04-20
EP2444034B1 (en) 2017-05-31

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