CN101247777A - 临时性支架 - Google Patents

临时性支架 Download PDF

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CN101247777A
CN101247777A CNA2006800310798A CN200680031079A CN101247777A CN 101247777 A CN101247777 A CN 101247777A CN A2006800310798 A CNA2006800310798 A CN A2006800310798A CN 200680031079 A CN200680031079 A CN 200680031079A CN 101247777 A CN101247777 A CN 101247777A
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CN101247777B (zh
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T·尼斯尔
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Qualimed Innovative Medizinprodukte GmbH
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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
    • 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
    • A—HUMAN NECESSITIES
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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
    • 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
    • A61F2/844—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents folded prior to deployment
    • 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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    • 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
    • A61F2002/91533—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 characterised by the phase between adjacent bands
    • 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
    • A61F2002/9155—Adjacent bands being connected to each other
    • A61F2002/91575—Adjacent bands being connected to each other connected peak to trough
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2002/9528—Instruments specially adapted for placement or removal of stents or stent-grafts for retrieval of stents
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/0054—V-shaped

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Abstract

本发明涉及一种临时性支架，具有许多彼此相邻环段，所述支架在植入到身体内腔后可被其再度移出，其中所有的环段(3a、b、c、…)始于一根在支架长度上延伸的脊柱(2)并且具有至少两个削弱区(4、5、6)，这些削弱区在支架移出的过程中使环段(3a、b、c、…)能够折叠起来，并且所述脊柱(2)在其近中端(7)上具有一个回收元件(8)。

Description

临时性支架
技术领域
本发明涉及一种临时性支架，具有许多在支架长度上设置的环段，所述支架在植入到身体内腔后可被再度移出。本发明尤其涉及一种适用于脉管性的、比方说冠状的或外周的血管的支架，但在相应的尺寸设计情况下也可以用于其它的身体内腔。
背景技术
管腔内支架以许多应用形式为人所知，这些管腔内支架为了向植入部位输送而具有一个缩径并且在植入过程中膨胀到所期望的最终直径。这种类型的支架通常设定用于耐久的植入，即，它们规定用于置留于身体内的植入位置。
但在很多情况下，植入的支架在一定的持续时间后便失去其功能；它完成了其目的，例如是扩张血管、稳定功能障碍或封闭瘘管或分支，并且不再被需要。
在其他情况下，也有必要再度取出曾放置的支架，如在错误放置或不相容性反应情况下。但取出曾放置的支架通常费用昂贵而且并非没有危险。尤其是在取出冠状支架(Koronarstents)时，总是再度导致给病人带来负担的并发症。相应的情况也适用于非脉管支架(nicht-vaskulreStents)，例如将其应用到呼吸道、食管中或应用在泌尿科学中。
发明内容
从病人的角度出发，按上文所述观点，现存的支架还不是最佳的支架。因此期望提供一种支架，该支架在完成其功能后可以顺利地被再度取出，而尤其对病人没有负担。
一种这样的支架应具有通常的支架特征和功能，即，适应于支撑、扩张和稳固身体内腔。在这种功效结束后，它应该能够以最小的成本毫无残留地被再度取出。
这一目的通过一种前言所述类型的临时性支架来实现，其中，所有的环段始于一根在支架长度上延伸的脊柱并且具有至少两个削弱区，这些削弱区在支架的移出过程中使环段能够折叠起来，并且所述脊柱在其近中端上具有一个回收元件。
根据本发明的临时性支架规定用于以通常的方式方法被植入到身体内腔中。其结构和其各环段这样构成，以致在功能实现后，该支架可以按其进入到身体中的方法顺利地被再度移出。
根据本发明的临时性支架尤其是一种适用于植入到冠状的或外周的血管区域内的脉管支架(vaskulrer Stent)。但它在相应确定尺寸的情况下同样也是适用于其它的身体内腔的支架，如在泌尿科学中适用于尿道、用于在气管和支气管区域中的呼吸道、用于肠道区域，尤其是十二指肠、用于食管和用于胆管。此外，与这些附加的能力无关，根据本发明的临时性支架针对一种在脉管区域(vaskulren Bereich)内的支架进行说明。
脉管支架通常由一种管状的坯料切割而成并且被减小到一个通过一个引导导管能够实现应用的直径，以便植入。为此该类支架可以皱缩到一个球囊上，该球囊然后在植入位置将其通过液压方式扩张到所期望的直径。作为备选方案，也使用由形状记忆合金制成的支架，它们在一个导管的外部约束下获得一种体积减小的形状，然而在从导管取出并且取消外部约束后便扩张到其目标直径。除了这种应力引起的马氏体转变外，也可以考虑一种由温度引起的马氏体转变或者两者的混合形式。本领域的技术人员熟悉这些可能性。
本发明的意义上，关于支架，概念“近中”(proximal)表示在导管侧的或朝向治疗医生的。相应的是，“远中”(distal)应被理解为在植入后背离导管的。
移出支架应理解为取回支架，该支架已植入并且不再是需要的，也就是如取回植入错误放置的或有缺陷的支架。但最重要的是那些在完成其功能后不再需要或者必须更换的支架。
对于根据本发明的临时性支架来说，重要的是，一方面在环段中配置一些削弱区，另一方面在近中端上具有回收元件。
回收元件和削弱区这样相互协调，以致在回收支架过程中，各环段在削弱区向内折叠或自行折叠起来，从而能够将支架拉回到一个导管中。这类导管可以涉及一种传统的引导导管，但也可以涉及一种专门设计的回收导管，该回收导管在其远中端具有一个更高强度或刚度的区，它易于支架的拉回和折叠。
根据本发明的临时性支架可按通常的方式被应用，即，使其皱缩到一个球囊上、导入到使用位置并放置在那里并且液压地通过所述球囊上膨胀。作为备选方案，也可为采用形状记忆合金，例如镍钛诺。在利用应力引起的马氏体转变的现象情况下，支架在一个导管的外部约束下可以被拖拽到使用位置并且在那里被释放；释放后，支架膨胀到先前为其设计的形状(aufgeprgte Form)。
根据本发明的临时性支架优选这样构成，以致它们在目标血管中以完全膨胀的状态存在。环段在完全膨胀状态下形成一种即使在支架只有小的材料厚度和肋宽情况下也能保证一种高的稳定性的或多或少规则的环或圆。在完整圆形构成的环段情况下，在径向受载时，削弱区也不会再生效。此外，圆形的环段本身可以简便而安全地植入，并且除了足够的径向力外，在与相应的血管走向的匹配方面还带来一种足够灵活性。
除在植入过程中对血管带来尽可能低的损伤外，必需的前提条件还在于安全的移出。因此，不允许支架相对向内生长，而且它必须可按规定的方式进一步折叠起来。因此，为避免向内生长，有意义的可以是，对支架进行涂层，尤其是还用一些抑止细胞生长的物质。这类支架和涂层对本领域的技术人员本身是已知的，例如参阅那些含有一种抑制增生的活性物质的组分，如雷帕霉素(Rapamyzin)或泰素(Taxol)的塑料涂层。
在植入过程中，支架被有序地压入到血管壁中。这种到血管壁中的压入用于将支架固定在其植入位置上并防止随后漂走。“压入深度”大约为材料厚度的一半。但正是这种压入在支架取出过程中可能造成对血管壁的机械损伤。
为抵消这种损伤，根据本发明的支架可以在其外壁上用一种在植入位置存在的条件作用下溶解的材料进行涂层。这类材料是已知的并且可以由塑料构成，但也可以由金属构成。一旦支架的外部涂层大部分地或者完全地溶解，该支架显然可以更简单地被再度取出，并且明显减小了损伤管壁的危险。
合乎目的的是，支架的外部涂层占支架总厚度的25至75％，尤其是大约40至60％。当涂层为50至100％μm时，脉管支架的壁厚通常在40至70μm的范围内。
与所谓的药物洗脱支架(Drug-Eluting-Stents)相反，为了最小化并且尽可能地排除对血管壁的损伤，根据本发明的支架专门为了移出仅在外部区域用一种可吸收的材料进行涂层。也可以附加地存在一个内壁的涂层，它具有一种通常的含有活性物质的材料。在这种情况下，内壁和外壁的涂层主要在其功能及目标确定上有区别。
涂层可以例如出自一种可生物降解的聚合物，如已将支架涂层用于释放活性物质。作为其他的可吸收材料，尤其还可以考虑在循环过程中可自行分解的金属，例如：镁和纯铁。由这些材料制成的自行可分解的支架例如描述在WO 99/003515 A2中。
支架的外壁的这种涂层通常在加工完成(电解抛光和清洗)和预皱缩之后进行。在预皱缩后，各环段相互之间非常近。然后可以从外部用涂料对安装在一个托架上的支架进行喷涂，由此在外面上实现一种理想的均匀过渡到支架侧面上的涂料分布。这首先适合于由塑料构成的涂层。
如果存在一根与支架连接的回收丝，它应该同样至少在其远中区域进行涂层，在这种情况下，涂层可以单侧或者全方位进行。
为了用一种快速溶解的金属如纯铁或镁进行涂层，可借助不同的技术。一方面，可以在支架切割前将由不同材料制成的细管相互连接(夹层技术(Sandwich-Technik))。作为备选方案，也可借助溅射法或滚轧法进行涂层，尤其是在镁情况下，等离子涂层以及超声波涂层也值得考虑。对于用一种快速腐蚀的金属进行外部涂层的情况，尤其优选的是，由一种夹层管或夹层管子(Sandwichrohr oder-tube)制造支架。
根据本发明的支架的结构包括一根脊柱或纵向元件和一些基本上以直角起始于所述脊柱的环段，除了足够的径向力外，还带来一种高的灵活性。该脊柱特别柔韧并且可以与血管的走向最佳地匹配。起始于脊柱的环段相应地横向于血管的走向进行取向，这对于扩张和支撑尤其重要。具有基本上完整圆形膨胀的环段的支架的膨胀实现了一种对血管壁的良好的支撑和一种对血管内腔的按规定的方式的扩张。
根据本发明的临时性支架具有至少两个削弱区，它们优选在脊柱两侧紧邻脊柱设置。该支架尤其具有至少三个削弱区，两个在脊柱两侧紧邻脊柱设置，第三个设置在所述环段的与脊柱对置的一侧上。同样也存在三个以上的削弱区，但无论如何其中两个紧邻脊柱，而剩下的以镜像对称方式分布在相应环段的圆弧上。但一种支架证明是特别适合的，它具有三个削弱区，其中两个削弱区在两侧邻接脊柱，一个第三削弱区在每一环段上相对于脊柱错位180°。
根据本发明的支架具有一个在相应的使用范围中通常的长度，一般带有5到25个环段。根据肋宽和必要的间距，段的数量也可以或多或少。段间距在冠状区域大体上在0.5至3mm范围内。
削弱区本身可以是一些材料厚度较小的区。作为备选方案，也可在削弱区减小环段的肋宽。在两种情况下，削弱与材料减少相关，其中材料减少可共计达到50％，优选约为20至40％。
另外，也可以完全或部分地通过对相应区域进行局部热处理获得削弱区。这可以通过例如通过对相应区域的局部激光处理而实现，通过这种方式，支架材料在待形成削弱区内被短时加热，以致达到较低的强度。相应的热处理本身是已知的，尤其是对于优质钢，还有医用优质钢。
在削弱区，值得注意的是，支架的一个必要时存在的具有一种可吸收材料的外部涂层并不影响或取消这些削弱区的功能方式。即使在用可吸收材料进行涂层之后，削弱区也必须从中得以保留。
根据本发明设置的用于支架的回收元件近中地设置在脊柱上。对于回收元件，可以设想多种实施形式。一方面，回收元件可以设计为用于固定一个取回器(Retriever)的元件，例如环圈、套钩或吊环。取回器可以钩入到该元件中并因此将支架拉回到一个回收导管(Bergekatheter)中。但回收元件也可以是一根回收丝，它直接固定在脊柱上或者钩在一个环圈中并保留在支架上。这一变型尤其在小直径的脉管支架中是有利的，在一个支架只是短期插入的那些应用中也是如此。这样的回收丝可以非常细，例如最大直径为0.3mm，并且在血管中保持不变直到支架的回收。在植入后，通常可以取出引导导管和“大的”吊环。通常一个套管就足以临时性引导回收丝。根据支架尺寸，回收导管同样可以设计得非常精致，外径甚至低于1mm，并且一般通过一个通常的闸门导入。
但是，尤其对用于大口径血管和血管外的内腔的临时性支架的情况，优选的是支架仅仅具有一个回收元件的变型，一个取回器可以钩入到该回收元件中。
不言而喻，根据本发明的支架可以配备可能必要的不透射线的标记。标记的优选的安放位置是回收元件的附近或者是回收元件配有标记特性。
根据本发明的支架由通常的材料制成，尤其是铁(纯铁)、优质钢(医用优质钢)、金、铂、形状记忆合金(镍钛诺)和钽。同样也可使用由适合的塑料材料制成的支架。
支架以通常方式由一个管状的坯料切割而成，其中尤其是应用激光技术。坯料通常具有70至300μm的壁厚，冠状支架在电解抛光后为40至70μm。通过支架通常膨胀直到完整圆的方式，仅通过形状就能产生一种高的径向强度，因此，可以考虑50μm或更小的微小壁厚。
各环段以及脊柱的肋宽在40至500μm范围内，在冠状支架中，肋宽在40至80μm范围内。由于一个完全膨胀成圆的环段的大的径向强度，肋宽通常可以比在血管支架(Gefβstents)中的小。
只要根据本发明的支架应用于非脉管目的，材料厚度和肋宽就以在相应的应用领域中通常的尺寸和强度为依据。
附图说明
通过所附的各附图进一步阐述本发明。其中：
图1一种根据本发明的具有完全膨胀的各环段的临时性支架的视图；
图2一种根据本发明的支架处于加工状态的展开图；
图3图2的支架的细节图，用于说明各环段与脊柱的连接，和
图4具有外部涂层的支架的结构及其功能方式的横截面图。
具体实施方式
图1示出一种根据本发明的临时性支架1，其脊柱2和各单个环段3a、3b、3c、...、3m处于完全膨胀的状态，在该状态下，各环段都膨胀成一个完整的圆。各环段3a...3m在支架的长度上等距排列并且通过共同的脊柱2相互连接。各环段3a...3m大体上垂直于脊柱2。环段3的和脊柱2的肋宽约为50μm，材料厚度同样也在50μm的范围内。
环段3中的每一个都具有三个削弱区，其中两个4、5紧邻脊柱设置。一个第三削弱区6相对于脊柱2错位180°，也就是说，就环段而言，该第三削弱区与脊柱2对置。这些削弱区设立在每一个环段3上。削弱区4、5、6显示为减小了肋宽的区。
具有一个近中端7和一个远中端9的脊柱2在其近中端7上具有一个回收元件8，回收丝10连接到该回收元件上。在图示情况下，回收丝10与回收元件8固定连接。在另外的实施形式中，回收元件8可以是一个环圈，一个单独的取回器嵌入到该环圈中。回收丝10例如还可以通过一个焊接点直接固定在脊柱2上。
图2以展开图的形式示出一个根据本发明的处于加工状态的临时性支架。各环段3a...3i在此状态下构成为波形并且具有削弱区4、5、6，如在图1中所示的那样。一些肋宽较小的区4、5紧邻地位于脊柱2两侧，其中肋宽减小约40％。第三个削弱区6相对于脊柱2错位180°，同样也具有一个减小40％的肋宽。
回收元件8被图示在脊柱2的近中端上，该回收元件将回收丝10与脊柱2连接在一起。
在图2中所示的支架在该形式中由管坯切割而成，并且为了植入，该支架皱缩到一个通常的植入球囊上。在皱缩到一起的状态下，波形的环段3a...3i进一步彼此挤缩，以致“波长”减小而“振幅”增加。在植入后，各环段3a...3i的波形走向得以延伸，即：环段3具有一个基本上圆形的走向，如图1所示的那样。
图3示出图2的图形一个局部，具有脊柱2、环段3a和在脊柱2两侧的削弱区4、5。5’表示环段3a的在削弱区的结构框架内已被切除的区域。
不言而喻，获取削弱区不仅可通过材料减少的方式，而且也可以通过材料削弱的方式。主要效果在于，在近中设置牵引力的情况下，必要时在回收导管管口作用下，环段3在削弱部位向内折叠并且允许将整个支架拉回到回收导管内。因此，回收导管明显可以具有一个比植入的支架更小的直径。
图4示出了根据本发明的具有外部涂层的支架的结构和功能方式。图示了一个支架1的一个环段3的横截面，其中环段3在其内侧31由一种耐久的材料构成，例如优质钢、镍钛诺或是钴/铬合金，而在其外侧32则具有一个由一种可吸收的或可腐蚀的材料例如纯铁或镁构成的涂层。支架1的环段3以其膨胀形式显示在植入位置，其厚度的约50％压入到血管壁A中。环段3的内侧31突入到血液循环系统B中。
图4b示出一种设有一个聚合物涂层的支架1的一个环段3的横截面。固有的支架主体31(对应于内侧)由一种通常的支架材料制成，可为优质钢。支架在外侧具有一个由一种可吸收聚合物构成的涂层32，它覆盖了支架的外侧并朝各侧面那边逐渐变薄。这种变型同样以其厚度的约一半突入到血管壁A中，其中环段3的内侧31突入到血液循环系统B中。
功能方式在于，在外侧32上的材料，被称为一种受腐蚀的金属或一种可吸收的聚合物涂层，在血液和免疫系统的影响下或多或少地被快速分解，继而在数日或数周以后，在血管壁A内的支持物被减少或溶解。一旦在外侧32的涂层材料被吸收，支架就可以从血管中移出，而不存在损伤血管壁的危险。

Claims (19)

1.临时性支架，具有许多彼此相邻的环段，所述支架在植入到一个身体内腔后可被再度移出，其特征是：所有的环段(3a、b、c、...)始于一根在支架(1)长度上延伸的脊柱(2)并且具有至少两个削弱区(4、5、6)，这些削弱区在支架移出过程中使环段(3a、b、c、...)能够折叠起来，并且所述脊柱(2)在其近中端(7)上具有一个回收元件(8)。
2.根据权利要求1所述的支架，其特征是：所述环段(3a、b、c、...)相互平行地延伸。
3.根据权利要求1或2所述的支架，其特征是：所述环段(3a、b、c、...)在完全膨胀状态下呈圆形。
4.根据上述权利要求之一所述的支架，其特征是：所述环段(3a、b、c、...)具有至少三个削弱区(4、5、6)。
5.根据权利要求4所述的支架，其特征是：所述支架在两侧邻接脊柱(2)具有两个削弱区(4、5)并且相对于脊柱(2)错位180°具有一个第三削弱区(6)。
6.根据上述权利要求之一所述的支架，其特征是：所述削弱区(4、5、6)是材料强度较小的区。
7.根据上述权利要求之一所述的支架，其特征是：所述削弱区(4、5、6)是环段(3a、b、c、...)的材料厚度和/或肋宽较小的区。
8.根据权利要求7所述的支架，其特征是：所述削弱区(4、5、6)是完全或部分地通过局部热处理被削弱的区。
9.根据上述权利要求之一所述的支架，其特征是：所述脊柱(2)具有一个用于固定一个取回器的元件，作为所述回收元件(8)。
10.根据权利要求9所述的支架，其特征是：所述元件(8)是一个环圈，一个套钩或一个吊环。
11.根据上述权利要求之一所述的支架，其特征是：所述脊柱(2)近中具有一根回收丝(10)。
12.根据上述权利要求之一所述的支架，其特征是：所述支架由铁、钢、贵金属或镍钛诺制成。
13.冠状支架，根据上述权利要求之一所述。
14.根据权利要求13所述的冠状支架，其特征是：具有在20至100μm范围内的壁厚。
15.根据权利要求14所述的支架，其特征是：具有在40至60μm范围内的壁厚。
16.根据权利要求13至15之一所述的支架，其特征是：具有在50至500μm范围内的肋宽。
17.根据上述权利要求之一所述的支架，其特征是：具有一个由一种在血管系统内可吸收的材料制成的外部涂层。
18.根据权利要求17所述的支架，其特征是：所述可吸收的材料是一种在血管系统中可溶解的塑料、纯铁或镁。
19.根据权利要求17或18所述的支架，其特征是：所述支架的外部涂层占支架壁厚的25至75％。
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