CN101951860A - 具有使邻接撑杆相互连接的单一应力集中区的球囊可扩张的可生物性吸收支架 - Google Patents

具有使邻接撑杆相互连接的单一应力集中区的球囊可扩张的可生物性吸收支架 Download PDF

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CN101951860A
CN101951860A CN2008801274779A CN200880127477A CN101951860A CN 101951860 A CN101951860 A CN 101951860A CN 2008801274779 A CN2008801274779 A CN 2008801274779A CN 200880127477 A CN200880127477 A CN 200880127477A CN 101951860 A CN101951860 A CN 101951860A
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support
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CN101951860B (zh
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J·H·康蒂利亚诺
Q·张
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Johnson and Johnson Medical SAS
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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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
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    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155—Adjacent bands being connected to each other
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    • A—HUMAN NECESSITIES
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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
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0036—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in thickness
    • 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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Abstract

一种可扩张、可植入的医疗装置，例如由聚合物材料制成的管腔内支架(10)，包括以连续的串联和使交变应力集中于相互连接邻接撑杆(16)的终点的接合部(18)的多条伸长撑杆(16)。当支架(10)处于扩张情形时，邻接撑杆(16)形成扩张的基本上成V-形并且使应力集中在接合部(18)中。接合部(18)确定用于相互连接的邻接撑杆(16)的枢转点(P)。当支架(10)扩张时，各枢转点(P)基本上位于由撑杆(16)形成的V-形的对分线上。

Description

具有使邻接撑杆相互连接的单一应力集中区的球囊可扩张的可生物性吸收支架
发明领域
本发明涉及植入活体动物或人的体腔内以支持器官或维持其开放的可扩张的组织支持装置，而更具体地，涉及球囊可扩张的支架(stents)，其展开是支架材料的塑性变形的功能。
发明背景
可扩张的组织支持装置，例如球囊可扩张的支架，已经被开发用于植入身体通道中。支架典型地包括多列单元的相互连接的撑杆(struts)，其中各单元构成两条相互连接的邻接撑杆，这样在支架展开期间撑杆彼此背离旋转。在扩张时撑杆向支架提供径向支撑力(radial strength)。支架撑杆和相互连接也可起包含药剂或生物活性剂的作用，其通过已知的方式得到应用，所述方式有例如将它们包被在聚合物中或将它们放入撑杆或相互连接内(interconnections)的储库中，以在植入后释放入体内。
如在本领域中熟知的那样，当支架扩张，例如通过球囊扩张时，支架经历多种应力和张力(下文都称为“应力”)，导致支架构件的塑性变形，这样当球囊缩小时，支架的构造保持需要的形状和大小。
另外，发生在支架的某些区域的以使支架展开的变形兼具有弹性构件的张力和可塑性构件的张力。受应力的(stressed)支架材料的体积和在该材料中的塑性变形对弹性变形比率，主要控制(governs)所熟知的回弹现象(recoil)。因此，需要使受应力的材料的体积最小和使该体积的材料中的塑性变形对弹性变形比率最大。相反，期望的大的回弹，在植入期间，支架常常超扩张，转而引起身体通道的损害或炎症。
支架设计努力已经注重并且继续注重于选择(addressing)以上提及的与支架扩张相关的不需要的现象。例如，已经设计支架以包括在选择的点上的应力集中区(stress concentration regions)，例如，铰链，其典型地为小的和明确限定的。铰链典型地为这样的区域，在那里几何形状已经缩减以使变形发生在此区域。当具有应力集中区的支架扩张时，使应力位于这些区域内，其有效地降低受应力的材料的体积，由此使在支架其它区域中的应力最小。
人们已知支架设计包括在撑杆的每一端的应力集中区或铰链，这样使邻接撑杆相互连接的接合部(junction)包括两个应力集中区或铰链。参见，例如，2001年6月5日授权的美国专利序列号6,241,762，其通过引用结合于本文。由于材料的应变能力(stress capacity)的局限，采用已知的不锈钢或CoCr合金的支架设计典型地利用每根撑杆的两个应力集中区。典型地被用作支架制作的316L和CoCr合金两者均具有40％-50％的断裂延伸率。如果在支架展开期间的应力过大以致于引起支架延长超过支架断裂延伸能力，则支架有破裂并失效的倾向。通过使变形出现在撑杆的任一端，换言之，在两个铰链区，在各铰链区内的应力水平维持在低于材料的断裂延伸能力。如果仅在一个铰链中试图使撑杆之间扩张相同的水平，存在超过材料的应变能力的风险，除非铰链本身的几何形状增加足够大以使铰链中的应力水平降低。相反，可使撑杆之间变形的量减少以降低适于这些材料的应力水平。然而，将需要更多的撑杆以达到想要的展开直径，并且从而，将要使更多的材料植入体内，而这不一定是需要的。
铰链区占据支架结构中的体积，并且因此减少用于构成撑杆而可获得的支架材料的体积，撑杆提供给支架径向支撑力和药物传递功能。因而，支架内一列单元中的铰链的数量影响包括在该列中的撑杆的几何形状，并且作为结果，影响单元列的强度和药物传递能力并最终影响支架本身。
已经开发的另一个支架设计包括在撑杆中的单一应力集中区或铰链。参见，例如，2004年7月20日授权的美国专利号6,764,507，且其通过全文引用结合于本文。在这样的撑杆构型中的单一集中区域中，可制作铰链(集中区)的材料构成对铰链可吸收的应力的量的局限。基于目前在本领域中已知的用于制作支架的材料，具有在撑杆构型中的单一应力集中区的支架的铰链仅可经受大约与每根撑杆接合部构型具有两个应力集中区的在先技术支架的铰链一样的应力水平。
因此，为了实现撑杆之间同样的扩张角(expansion angle)，撑杆构型之中具有单一集中区的在先技术支架的铰链的轴长必需充分增加，以致于限制更高水平的塑性变形，避免在扩张期间单一铰链上的应力集中度增加，避免引起装置失灵。这样的长度的增加引起撑杆构型内具有单一集中区的在先技术支架中的铰链的长度，比每根撑杆接合部构型中具有两个集中区的支架的铰链的长度更长。增加支架中铰链的轴长的必要性，转而使由支架中铰链所使用的材料的体积增加，如上讨论这是不希望的。
因此，存在对球囊可扩张的组织支持装置的需求，所述装置将应力集中在装置中减少了体积的材料上并且避免了向装置中的区域施加应力，当承受不适当的应力时，装置的理想功能性可能被削弱。
发明简述
依据本发明，一种可扩张的、可植入的医疗装置，例如支架，呈现框架结构，例如聚合物框架结构的形式，其具有由多个柔性接头相互连接并结合在一起的多条环圈(hoop)构件，以形成基本上圆筒形装置。该装置可从具有第一直径的圆筒扩张至具有第二直径的圆筒。环圈构件被成形为连续的一系列基本上(轴向)纵向取向的放射状撑杆和交替的应力集中接合部。当圆筒处于第一直径的非扩张形式时，邻接撑杆基本上平行。各个接合部确定用于连接的邻接撑杆的枢转点。当支架扩张至第二直径时，应力集中于起铰链作用的接合部，并且附着在一起，邻接撑杆围绕枢转点旋转，基本上对称并均一地彼此远离，形成大体上的V-形。当圆筒处于第二直径时，各枢转点基本上位于由撑杆形成的V-形的对分线(line bisecting)上。
在一个实施方案中，接合部具有比附着至接合部的撑杆的横切面积小的横切面积。
图的简述
本发明的其它目的和优点将从对目前优选的实施方案的详细描述中凸显出来，该描述应该被认为与附图相关联，其中同样的标识(references)指相同的元素，且其中：
图1是依据本发明的示例性非扩张支架的部分平面表示图。
图2是图1的支架平面表示图的部分放大图。
图3A是依据本发明一个实施方案的非扩张支架的示例性单元的平面表示图。
图3B是在图3A中显示的以扩张的构型呈现的支架的示例性单元的平面表示图。
发明详述
可从许多的适宜的可生物相容的材料，包括聚合物材料制作可植入的医疗装置。这些聚合物材料的内在结构可被改变为利用聚合物的机械和/或化学处理。这些内在的结构改变可被用于构造具有特殊的总特性(gross characteristics)的装置，例如结晶和无定形形态以及选择的分子取向，如在“球囊可扩张的生物可吸收性药物洗提支架(Balloon Expandable Bioabsorbable Drug Eluting Stent)”，2007年5月11日提交的美国序列号11/747,699(“′699申请”)(转让给该申请的受让人并通过引用结合于本文)中所描述。尽管在扩张过程中经历应力的可扩张的、可植入的装置中的缩减材料体积的本发明，通过使在装置扩张过程中产生的应力集中在减少数目的小的、局限的区域内，并且同时增强构件在经历装置扩张过程中位移下的位移能力，应用于许多可植入的医疗装置中，但为了易于解释，以下详述将着重描述示例性支架。
图1阐述依据本发明的示例性支架10的部分平面图。参考图1，并也参考示于图1的支架10的部分的放大图的图2，支架10包括由多个柔性接头14相互连接的多条环圈构件12。环圈构件12成形为连续的一系列基本上纵向(轴向)取向的放射状撑杆16和交替的应力集中接合部18。放射状撑杆16和交替的接合部18的合并形成基本上正弦曲线的图形。尽管在平面图显示，环圈构件12本质上为通过柔性接头14连接在一起的环形部件(members)，以形成为基本上管状的或圆筒形支架结构。得到的圆筒是可从如示于图1的支架10处于非扩张的构型，其邻接撑杆16基本上平行时的第一直径，扩张至当已经将支架扩张以用于植入体内通道并且邻接撑杆16具有通常的构型的第二直径，如在以下文伴随图3B的描述所讨论的。
参考图1，接头(connectors)14和撑杆16可包括任选的孔穴(openings)23，其优选装载试剂，例如药物，用于传递至支架10植入的体内通道。为了列出可能的试剂，参见，例如，′699申请。
尽管可将环圈构件12设计为具有许多设计特性和采取许多构型，在支架10的示例性实施方案中，放射状撑杆16的中心区域20比末端22宽。可将此设计特性应用于多种目的，包括改善装置的径向支撑力或硬度，或增加可含荷载试剂的孔穴的面积。
依据本发明，支架10的几何形状和材料特征以及支架10的撑杆16和接合部18之间的相互连接，提供一列撑杆16中的单元，包括使两个邻接撑杆16相互连接的接合部18中的单一应力集中区24，和提供单元的邻接撑杆16围绕应力集中区24中的枢转点P均一并对称地彼此远离的旋转，以在支架扩张过程中形成基本上的V-形。在支架扩张期间，应力在位于接合部18中支架10的相对小的预定区域24的集中，导致常常被称为“铰链转动(hinging)”，此处铰链小，其中的集中区24在支架扩张期间的应力非常高。接合部18，例如，如本领域常规已知的那样，可构成延性铰链(ductile hinge)。
参考图2，其阐述包括在接合部18相互连接的邻接撑杆16的支架10的示例性单元30，并且省略其中撑杆16中的用于含试剂的孔穴，接合部18之中的应力集中或铰链区24包括分别相互连接至邻接撑杆16A和16B的终端部分的28A和28B的终端26A和26B。铰链区24优选具有相对于撑杆16的邻接几何形状而言小的横切面积。另外，撑杆16A和16B的中心区20的横切面积基本上大于铰链区24的横切面积。基于这些几何学上的差异，当支架10扩张时，应力位于并集中在铰链区24，并且撑杆16A和16B围绕区域24中的枢转点P基本对称并均一地彼此远离地旋转。当支架10扩张时，单元30的撑杆16A和16B确定大体上的V-形，其中V-形的顶点在P点且V-形的对分线通常通过P点延伸。
图3A是依据本发明的一个实施方案的处于非扩张(无形变)构型的支架的单元130的平面表示图。图3B是处于扩张(形变)构型的图3A的单元130的平面表示图。参考图3A，单元130包括在接合部18相互连接的基本上平行的邻接撑杆16A和16B。参考图3B，如上讨论的，在扩张的单元130中，撑杆16A和16B形成基本上的V-形和将由撑杆16A、16B形成的V-形对分的线BL通过区域24中的枢转点P延伸。在支架扩张期间，单元130的撑杆16A和16B围绕位于接合部18中铰链区24内的枢转点P对称并均一地彼此远离地旋转，以形成V-形。因此，在扩张的单元130中，从线BL至撑杆16A的距离A等于或基本上等于从线BL至撑杆16B的距离B，此处的距离A和B是沿着与线BL成直角的线OL并在撑杆16A和16B之间延伸测量的。
在本发明的支架的一个实施方案中，与邻接撑杆相比，接合部18的横切面积是缩减的。因而，当支架扩张时，应力集中且基本上位于铰链区24中。
在本发明的支架的另一个实施方案中，参考图3B，接合部18被构造为具有几何形状并且从预定材料构造，以便当支架扩张时，形成V-形单元130的邻接撑杆16，可围绕P点旋转，并且对称和均一地离开线BL旋转以确定邻接撑杆16之间的角α最大至约180°。
在备选的实施方案中，柔性接头14的终端可在不同的位置连接至环圈元件12上，不像如示于图1的。例如，接头14可令人信服地在沿着撑杆16或接合部18之外的任何点上连接。连接邻接撑杆柱的柔性接头14的数目可随从一个柔性接头至如存在的单元那样多的柔性接头不同而变化。而且，应该理解，柔性接头14可具有任何想要的形状、许多设计特性和许多构型，如在例如，′699申请中描述的。在支架等可植入的的装置中，在接头14结构上的仅有的局限，和连接至环圈元件12的伸缩接头(flex connector)14的连接位置，是结构的结合处(combination)，并且接头14的连接不妨碍用作应力集中器的铰链区24，和当支架扩张时，提供单元的邻接撑杆16围绕接合部18中的枢转点P彼此远离地对称旋转，以形成V-形。
在本发明的支架的一个实施方案中，撑杆16优选从使撑杆16在弯曲中比接合部18更硬的材料制成。因此，在支架扩张期间，撑杆16比接合部18更抵抗变形。因此，在不如撑杆16硬的邻接撑杆16的终端的铰链区24，变成应力集中器，并在扩张期间使之全部或大部分变形。当全部或大部分变形位于铰链区24时，铰链区24基本上适应支架和支架的其它区域，例如撑杆16的所有扩张，有利地在扩张期间不经历任何显著的应力。通常为低应力区的撑杆可因此，任选包括在策略上放置孔穴以装载试剂，例如不透射线剂(radioopaque agent)。
制作本发明支架的接合部18的材料优选具有正好发生进入变形的可塑性区域的断裂延伸特征。接合部18的材料，例如，包括在′699申请中描述的聚合物材料。具有正好发生进入变形的可塑性区域的断裂延伸的材料，例如，具有比用于支架的现有的金属的断裂延伸能力大40-50％的材料是优选的，这样应力可定位于接合部18，和因此远离支架的所有或基本上所有的其它区域。
在本发明的支架的另一个实施方案中，用任何聚合物材料形成支架的构件，例如在′699申请中描述的，只要当支架扩张时，应力集中并定位于接合部18。
因此，本发明在每根撑杆接合部构型中具有单一铰链区的支架，提供优于在先技术支架设计的下列优点。使用每根撑杆接合部构型单一的铰链区，例如，在聚合物支架系统中，减少在一列单元中铰链区的数量，并且因而，缩减在支架扩张期间经历变形的材料的体积。铰链区的数量的减少并且还有功能为支架中应力集中区的材料的总体积的缩减，转而增强在变形区域(deformed regions)中的应力水平，产生可塑性张力对弹性张力的高比率，以减少支架回弹。
构造给定尺寸的、具有减少较小的、预定铰链区数量的基于每一撑杆接合部构型有单一铰链区的本发明的支架的能力，提供现有的支架设计中多种有益的实施，而不用改变支架的总尺寸。首先，支架的单元柱(cell column)可具有短于在先技术支架中单元柱的轴长的轴长，并且还具有比得上先技术支架中单元柱的径向支撑力(radial strength)和硬度。另外，可缩短支架中单个单元柱的轴长，这样增加的单元柱的数量可纳入相同总轴长的支架中，其有利于全部支架径向支撑力和硬度。再有，可增加一列支架中单元的撑杆的轴长，而不增加柱的总轴长，因此提供现有的支架设计增加的力量和硬度，和如果需要的话更多空间以荷载试剂。
再有，依据本发明，使用使单元中邻接撑杆的终端相互连接的单一铰链区，将所有或基本上所有的应力集中在单一铰链区上，这样当支架扩张时，所有或基本上所有的这样的应力从所有或基本上所有的撑杆移开。因此，所有或基本上所有撑杆可用作药物储库。
另外，支架扩张期间撑杆上以及还有支架中材料而不是应力集中接合部的材料上的应力的减少，在支架在例如，内腔中扩张后，减少撑杆以及此类其它支架材料的回弹。例如，在每根撑杆接合部构型具有单一铰链区的聚合物支架系统中，此处聚合物材料构件在铰链区中，在它们变形时，具有显著的断裂延伸和局部变得横截面减少，扩张期间受应力的支架中材料的体积减少，因此减少回弹。
再有，选择的具有增强的吸收应力的能力的聚合物材料，例如具有分子取向的聚合物、具有可塑剂的聚合物和如在′699申请中描述的聚合物混合物，可用于制作本发明的支架中的应力集中接合部。通过使用这样的材料，本发明的支架可包括可吸收比在先技术支架中可比性应力集中区更多应力的较小的、局限的区域，因此使吸收应力的支架中材料的总体积进一步减少。
以下实施例是对本发明的原理和实践的阐述，尽管不受其限制。本发明的范畴和精神内的多个另外的实施方案，一旦具有本公开的利益，对本领域专业技术人员而言将是显而易见的。
实施例1
将具有每根撑杆接合部构型的本发明单一铰链区的支架的性能与具有每根撑杆接合部构型带有两个铰链区的支架比较。在本实验中，采用低能量准分子激光器从挤出的胶管(Dunn Industries，Inc.)用激光各自切割下两个支架。所述管由20/80(w/w)混合的10/90(mol/mol)聚(丙交酯-乙交酯共聚物)(PLGA，IV＝1.53，HFIP)/85/15(mol/mol)PLGA(IV＝3.2，CHCI3)组成，其外径(OD)为1.45mm且内径(ID)为1.04mm。将支架安置在3.0mm球囊扩张导管上，于37℃水浴中加热1分钟，然后用加压的盐水(10atm)使之扩张至最终大小为3.0mm OD x18mm长度，壁厚为200微米。第一个支架每根撑杆接合部构型具有两个铰链区，例如在2001年6月5日授权的美国专利号6,241,762(其通过引用结合于本文)中描述的，其包括12个列的撑杆，每个列包括6个单元，而依据本发明，第二个支架在每根撑杆接合部构型具有单一铰链区，包括13个列的撑杆，每个列包括6个单元。如本文描述的，第二支架在每根撑杆接合部构型具有单一铰链区。发现每根撑杆接合部构型的单一铰链区具有13.9psi的径向支撑力，而发现具有常规的每根撑杆接合部构型两个铰链区的支架具有10.6psi的径向支撑力。换言之，本发明的支架具有比具有在先技术的每根撑杆接合部构型两个铰链区的支架大31％的径向支撑力。另外，在将两个支架浸入38℃水浴中21天后，发现每根撑杆接合部构型具有两个铰链区的支架比最大扩张时回弹11.8％，同时发现本发明的每根撑杆接合部构型单一铰链区的支架比最大扩张时回弹11.6％。
实施例2
在配备荧光镜、特殊的X-线机器和看上去象普通电视屏幕样的X-线监视器的心导管实验室实施血管内支架手术。按常规方式使患者准备手术。例如，让患者躺在X-线台上并且盖上无菌被单。清洗腿上部内侧区域并用抗菌溶液处理以准备导管的插入。给患者局麻以使插入部位麻木而通常让患者在手术过程中保持清醒。将例如在实施例1中描述的、外径1.45mm和壁厚200微米的、每根撑杆接合部构型具有单一铰链区的聚合物支架安置在传统的3.0mm球囊扩张导管上。为了在动脉中植入支架，将导管用线穿过腹股沟中的切口向上进入受影响的血管，导管上在其头部和支架内具有的缩小的球囊。外科医生用荧光镜观看手术全过程。外科医生引导球囊导管至阻塞区域并使球囊膨胀，通常用盐水至约10atm或依据导管的使用说明书，引起支架扩张并压迫血管壁。然后，使球囊缩小并从血管取出。全部操作过程花费1小时至90分钟完成。将支架留在血管中以保持管壁张开和使血液如同功能正常的健康动脉样自由流动。细胞和组织将开始在支架上生长直至其内表面被覆盖。
尽管描述和阐述了本发明的优选的实施方案，对本领域专业技术人员而言应该显而易见的是，可在不背离本发明的原理的情况下对其作出多种修正。

Claims (18)

1.一种可扩张的、可植入的医疗装置，所述装置包括：
具有由多个柔性接头相互连接并结合在一起的多条环圈构件，以形成基本上圆筒形装置的框架结构，所述圆筒形装置可从具有第一直径的圆筒扩张至具有第二直径的圆筒，其中所述环圈构件形成为连续的一系列基本上纵向取向的放射状撑杆和交替的应力集中接合部，其中当圆筒处于第一直径时，撑杆中的邻接撑杆基本上平行，而当圆筒处于第二直径时，邻接撑杆基本上形成V-形；和
其中各个接合部确定用于连接的邻接撑杆的枢转点，并且其中当圆筒处于第二直径时，各枢转点基本上位于由撑杆形成的V-形的对分线上。
2.权利要求1的装置，其中的接合部是延性铰链。
3.权利要求1的装置，其中当圆筒处于第二直径时，应力集中在接合部中。
4.权利要求3的装置，其中集中于接合部的应力超过框架结构的屈服点。
5.权利要求4的装置，其中集中于接合部的应力低于框架结构的最终应力水平。
6.权利要求1的装置，其中的框架结构由具有预定分子取向的聚合物组成。
7.权利要求1的装置，其中交互的接合部具有相对于邻接几何形状而言较小的横切面积。
8.权利要求1的装置，其中当支架扩张时，邻接撑杆绕着枢转点的旋转基本上对称并均一地彼此远离。
9.权利要求1的装置，其中的框架结构包括聚合物材料。
10.一种在外科手术中使用可扩张的、可植入的医疗装置的方法，所述方法包括：
将框架结构植入身体通道，所述框架结构具有由多个柔性接头相互连接并结合在一起的多条环圈构件，以形成基本上圆筒形装置，所述圆筒形装置可从具有第一直径的圆筒扩张至具有第二直径的圆筒，其中的环圈构件形成为连续的一系列基本上纵向取向的放射状撑杆和交替的应力集中接合部，其中当圆筒处于第一直径时，撑杆中的邻接撑杆基本上平行；和
使框架结构从第一直径扩张至第二直径，其中当圆筒处于第二直径时，邻接撑杆形成基本上的V-形，其中被个接合部确定用于连接的邻接撑杆的枢转点，并且，其中当圆筒处于第二直径时，各枢转点基本上位于由撑杆形成的V-形的对分线上。
11.权利要求10的方法，其中的接合部为延性铰链。
12.权利要求10的方法，其中当圆筒处于第二直径时，应力集中在接合部内。
13.权利要求12的方法，其中集中于接合部的应力超过框架结构的屈服点。
14.权利要求13的方法，其中集中于接合部的应力低于框架结构的最终应力水平。
15.权利要求10的方法，其中的框架结构包含具有预定分子取向的聚合物。
16.权利要求10的方法，其中交互的接合部具有相对于邻接几何形状而言较小的横切面积。
17.权利要求10的方法，其中当支架扩张时，邻接撑杆绕着枢转点的旋转基本上对称并均一地彼此远离。
18.权利要求10的方法，其中框架结构包括聚合物材料。
CN200880127477.9A 2007-12-19 2008-12-17 具有使邻接撑杆相互连接的单一应力集中区的球囊可扩张的可生物性吸收支架 Expired - Fee Related CN101951860B (zh)

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