CN1838927A - 支架 - Google Patents

支架 Download PDF

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CN1838927A
CN1838927A CNA2005800007442A CN200580000744A CN1838927A CN 1838927 A CN1838927 A CN 1838927A CN A2005800007442 A CNA2005800007442 A CN A2005800007442A CN 200580000744 A CN200580000744 A CN 200580000744A CN 1838927 A CN1838927 A CN 1838927A
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CN1838927B (zh
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T·尼斯尔
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Qualimed Innovative Medizinprodukte GmbH
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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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    • 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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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Optics & Photonics (AREA)
  • Physics & Mathematics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Prostheses (AREA)

Abstract

本发明涉及一种支架(1)，它是一个用于一个变窄的体内血管的血管假体。支架(1)具有一个包括若干轴向连续不断的环形分段(3、4、5)的管状的撑架(2)，各环形分段在初始状态下由各经由各过渡部分(8)连续相互连接的分段斜撑(6、7)构成。各邻接的环形分段(3－5)通过各连接斜撑(9、10)相连接。为了避免在各分段斜撑(6、7)中的应力集中，其宽度总是从其中间的区域(16)开始向各过渡部分(8)的方向加大。其中各分段(6、7)波形弯曲。

Description

支架
技术领域
本发明涉及一种按照权利要求1的前序部分中的特征的支架。
背景技术
支架用于由于狭窄梗阻或变窄的体内器管的永久的或也只是短时的处理。
支架具有一个管状的金属撑架，其包括多个环形分段。这些环形分段由各经由各过渡部分连续相互连接的分段斜撑构成。各邻接的环形分段沿支架纵轴线通过各连接斜撑相连接。
支架具有极不同的实施形式和撑架(Stützgerüst)的设计。WO96/26689、US-A-5 861 027、DE 297 02 671 U1或DE 295 21 206U1列举了一些作为示范性的实例。
支架通过导管技术和类似的导入手段装入在狭窄区域内的体内血管内并在那里展开，同时撑架可从初始状态扩展到一个与其相反的直径加大的支撑状态。在所谓自身膨胀的支架中可以自动地实现该扩展过程。但其也可以借助于一个适当的器械、例如球胀导管引起。支架在血管内起支撑血管内壁的血管假体的作用。
由所谓形状记忆合金构成的支架属于自膨胀的支架。一种形状记忆合金是例如涉及一种镍钛合金的镍钛诺(Nitinol)。这种合金具有两个可界定的状态，其发生与温度有关。在预处理以后镍钛诺在冷态下是马氏体的，亦即可塑料变形而没有相关的弹性恢复力。在加热时材料转为一种奥氏体的弹性状态。这种形状记忆特性被用于支架的自折叠。
一种用于制造支架的通行的制造方法在于，将一薄壁的金属管按照撑架的外形切缝并接着扩展。借助于激光切割进行切缝过程。在这里通常采用原始直径为1.4-1.8mm的管，以便由此产生直径为5-12mm的支架。在至今流行的撑架设计中由于切割工艺为各分段斜撑提供一种平行的截面几何形状并且不可能不同。但这在各分段斜撑的各端或在过渡部分的区域内导致高的应力集中并从而导致高的断裂危险。
发明内容
因此从现有技术出发本发明的目的在于，提供一种在分段斜撑中的应力分布方面改进的支架，其中降低分段斜撑的各端中的应力并且沿分段斜撑的长度分布。
按照本发明该目的的达到在于一种按照权利要求1的特征的支架。
本发明的支架具有一个管状的撑架，它可从一个初始状态扩展到一个支撑状态。该撑架包括一些沿支架纵轴线连续不断的环形分段，这些环形分段由沿撑架的圆周方向连续相互连接的各个分段斜撑构成。各邻接的环形分段通过各连接斜撑相连接。以下措施形成本发明的要点，即各分段斜撑波形弯曲并且各分段斜撑的横向于斜撑纵轴线测量的宽度从中间的区域起向各过渡部分的方向加大。各分段斜撑的沿撑架的圆周方向测量的宽度沿其长度延伸保持相等的。因此各分段斜撑在垂直测量时在中间的区域比在其各端是较窄的，借此使应力沿一个分段斜撑的全长分布并且受高载荷的各端通过较大的截面宽度卸载。这在分段斜撑的各端的分别临界的区域内减少断裂危险并从而导致一个支架的显著提高的使用寿命。
撑架在无相互平行延伸的直线的各斜撑部分上具有波形结构，其中各分段斜撑顺着一个连续的外形延伸从中间的区域分别向其各端加宽。
优选一个分段斜撑的波半径与宽度之比值从中间起向分段斜撑的各端以一比值10∶1至15∶1变化。
本发明的支架在高的柔性下具有很好的皱缩性。其在支撑状态下的特征是其高的稳定性和高的径向刚度同时改善再狭窄率。
支架由金属制成。在这方面可采用所有可变形的医学上可能的金属或金属合金，例如不锈钢、钴合金(Phynox)、纯铁或特别是镍钛合金。
借助一个激光束通过一个优选金属管的切缝实现撑架的制造。激光束在以一个例如为20-30μm的宽度聚焦时走过预定的截面形状。在这方面通过沿一个分段斜撑的纵向方向过渡部分那边的相应的半径选择和半径变化实现在分段斜撑宽度上的几何变化。
特别的优点是，可以通过原管的简单切缝产生撑架的外形或结构，而不必全部制出几何形状。
对实际有意义的是，本发明的支架也可以作为塑料支架。在这方面特别打算采用生物吸收的塑料。优选在这种情况下将支架构成为注塑成型件。
通过按照本发明的分段斜撑或撑架的成型还可以优化应力分布。
按照权利要求2的特征，设置第一连接斜撑和第二连接斜撑。每一连接斜撑具有一个沿撑架的圆周方向延伸的腰，其在两侧经由轴向部分连接于一个过渡部分。各连接斜撑的这种结构有助于一个支架的长度稳定性。一个理论上由于一个扩展过程和各分段斜撑向一个扩展的延伸的形状的过渡产生的撑架长度缩短由各连接斜撑中的腰来补偿。
有利地，第一连接斜撑的各轴向部分也波形弯曲，如其在权利要求3中设定的。其中轴向部分横向于轴向部分的纵轴线测量的宽度从腰开始向各过渡部分的方向增大。
被认为特别有利的是，轴向部分的曲率半径或波半径与轴向部分的宽度之比值从腰开始向各端在12∶1至20∶1的范围内变化。
连接斜撑沿圆周方向延伸的腰按照权利要求4的特征设置在两以轴向间距邻接的环形分段之间的空间内。
按照权利要求5的特征，第1连接斜撑总是从一个环形分段的两相互连接的分段斜撑的最凹处向邻接的环形分段的两相互连接的分段斜撑的最凹处延伸(权利要求6)。
与其相反，第二连接斜撑总是从一个环形分段的两相互连接的分段斜撑的尖端延伸到邻接的环形分段的两相互连接的分段斜撑的尖端。
在该方面按照权利要求7的特征设定，一个环形分段的第一连接斜撑和邻接的环形分段的第二连接斜撑沿圆周方向位错设置。
应用本发明的支架改进的措施按照权利要求8的特征在于，每一第三端面的过渡部分在朝支架纵轴线的方向看的端侧的环形分段上具有一个相对于各邻接的过渡部分的轴向凸出的加宽的顶端。
有利的倒圆的顶端确保支架的各端面的末端在一个血管壁上的不损伤的接触。因此血管壁不仅在一个支架的安装时而且在除去时几乎不受创伤。在皱缩的状态下各顶端覆盖邻接的过渡部分。因此大大减少损害邻接的血管壁的危险。
总体上得到一个在支撑状态下具有高的径向刚度的撑架。这以一种功能上符合目的的支撑的方式确保血管壁的很好的和均匀的导向。通过本发明的分段斜撑的实施形式可以避免不允许的高的应力集中。因此可以使本发明的支架很好地皱缩和扩展。支架例如可以安装在一球胀导管上通过一体内血管的弯曲很好地***。这种轻便性不仅对使用者而且对病人在植入时产生高的安全性。
附图说明
以下借助一个附图中所示的实施例更详细地描述本发明。其中：
图1一个本发明支架的支架模型处于展开的初始状态的一部分；
图2支架处于支撑状态的一端侧的部分；
图3一个分段斜撑的第一型式；
图4一个分段斜撑的第二型式；
图5表示一个分段斜撑的宽度相对于波半径的线图；以及
图6表示一个连接件的宽度相对于波半径的线图。
具体实施方式
图1和2分别示出一本发明的支架1的一展开的部分。图1示出支架1处于未扩展的初始状态的展开图。图2示出支架模型处于扩展的支撑状态的展开图。
支架1由金属特别由镍钛诺制成。它具有一个包括若干接连的环形分段3、4、5的管状撑架2。一个支架1的长度一般可以是不同的。图1和2未示出支架1的环形分段3、4、5的总数目。
环形分段3、4、5由各分段斜撑6、7构成，它们经由各过渡部分8连续相互连接。环形分段3、4、5相互间通过各连接斜撑9、10连接。人们可看出第一长的连接斜撑9和第二短的连接斜撑10。在每一连接斜撑9、10中设置一个沿撑架2的圆周方向U延伸的腰11，其在两侧经由轴向部分12、13、14、15连接在一个过渡部分8上。其中各腰11分别在两个以轴向间距a1、a2邻接的环形分段3、4或4、5之间的空间内。显然，环形分段3与4或环形分段4与5之间的间距a1和a2在支架1的扩展状态下尺寸是不同的，如图2中所示，其中a1大于a2。
分段斜撑6、7波形构成(对此也可参见图3和4)。其中每一分段斜撑6、7的横向于斜撑轴线Ls垂直测量的宽度Bs从中间的区域16开始向各过渡部分8的方向加大。分段斜撑6、7在中间的区域16内在两点P1之间比在其两端17在两点P2之间较窄。半径Rs沿一个分段斜撑6、7的长度延伸变化并且从中间的部分16开始向各过渡部分8的方向增大。因此使一个由外载荷在支撑状态下在体内器管内在分段斜撑6、7中产生的内应力沿一个分段斜撑6、7的全长分布。更高载荷的各端17通过在那里较大的宽度Bs卸载。按这种方式减少在分段斜撑6、7的各端1 7至各过渡部分8之间的过渡处的临界区域内的断裂危险。
第一连接斜撑9的轴向部分12、13具有一个符合于分段斜撑6、7的外形的波形的弯曲。轴向部分12或13的横向于轴向部分12、13的纵轴线Lv测量的宽度Bv从腰11开始向各过渡部分8增大。
第一连接斜撑9以其轴向部分12、13总是从一个环形分段3的两个相互连接的分段斜撑6、7的最凹处18延伸到一个邻接的环形分段4的两个相互连接的分段斜撑6、7的最凹处19。与此相反，第二连接斜撑10总是从一个环形分段4的两个相互连接的分段斜撑6、7的尖端20延伸到一个邻接的环形分段5的两个相互连接的分段斜撑6、7的尖端21。第一连接斜撑9和第二连接斜撑10在这里从环形分段3、4到环形分段4、5分别沿圆周方向相互位错设置。
如借助图2可看出的，每一第三端面的过渡部分8在端侧的环形分段3上具有一个相对于各邻接的过渡部分8轴向凸出的加宽的顶端22。每一个顶端22具有一个凸面倒圆的端面部分23和各向过渡部分8那边凹面倒圆的凹槽部分24。在皱缩的状态下各顶端22以其各凹槽部分24搭接各邻接的过渡部分8并将其覆盖。各邻接的过渡部分8就这样处于各顶端22的保护或遮盖之下。因此血管壁不仅在一个支架1的安装时而且在除去时几乎不受创伤。并且倒圆的顶端22在安装时确保支架1在血管壁上的小心的支承面。
图3和4示出一个分段斜撑6或7的两种型式，包括沿分段斜撑6、7的长度的宽度变化图。
宽度a在一个分段斜撑6、7的起端和终端是相等的。宽度a在圆周方向U沿分段斜撑6、7的全长同样等于“a”。横向于斜撑纵轴线测量的宽度Bs从中间的区域16开始向各过渡部分8的方向增大。宽度增大取决于一个分段斜撑6、7的斜度和波半径Rs。向各过渡部分8那边的过渡25、26同样当作半径成形。因此从分段宽度a向在中间的区域16内垂直测量的分段宽度Bs具有连续的过渡。这样的外形变化在支架1展开时导致连续的变形。
通过图3和4所示的型式比较明显的是，通过分段起端与分段终端之间的距离A和B的调整可以很好地设定分段宽度。如果选择距离A大于距离B，则由此得出垂直宽度d小于垂直宽度e(A＞B→d＜e)。
图5示出一线图，其中相对于一个分段斜撑6、7的波半径Rs描绘宽度Bs。所描述的是一个分段斜撑6、7的长度的一部分。斜撑宽度Bs在半径Rs为1.8mm时在中间的区域内为0.16mm。其中斜撑宽度Bs近似均匀地向终端增大。人们可看出，波半径Rs在斜撑宽度Bs为0.167mm时由2.4mm决定。在经实际测定的实施例中斜撑宽度Bs在一个分段斜撑的终端为0.175mm。总体上波半径Rs与斜撑宽度Bs的比值应该在10∶1至15∶1之间的范围内增大。
由图6得知一个线图，其中相对于波半径Rv描绘一个连接斜撑9或一个轴向部分12、13的宽度Bv。波半径Rv与连接件宽度Bv线性增大。其中连接件Bv的比值从中间开始向过渡部分8的方向增大，而且在12∶1至20∶1的比值范围内。
               附图标记清单
1  支架                   23  端面部分
2  撑架                   24  槽部分
3  环形分段               25  过渡
4  环形分段               26  过渡
5  形分段                 a1  间距
6  分段斜撑               a2  间距
7  分段斜撑               Bs 6、7的宽度
8  过渡部分               Bv 12、13的宽度
9  连接斜撑               L   支架纵轴线
10 连接斜撑               Ls 6、7的纵轴线
11 腰                     Lv 12、13的纵轴线
12 轴向部分               P1  点
13 轴向部分               P2  点
14 轴向部分               Rs 6、7的半径
15 轴向部分               Rv 12、13的半径
16 6、7的中间的区域       U   圆周方向
17 6、7的终端             A   距离
18 最凹处                 B   距离
19 最凹处                 a   宽度
20 尖端                   d   宽度
21 尖端                   e   宽度
22 顶端
权利要求书
(按照条约第19条的修改)
1.用于设置在一个体内器管内的支架，具有一个包括若干轴向连续不断的环形分段(3-5)的管状的撑架(2)，所述环形分段由各经由各过渡部分(8)连续相互连接的分段斜撑(6、7)构成并且各邻接的环形分段(3-5)通过各连接斜撑(9、10)相连接，其中每一分段斜撑(6、7)的横向于斜撑纵轴线(Ls)测量的宽度(Bs)从其中间的区域(16)开始向各过渡部分(8)的方向加大；其特征在于，各分段斜撑(6、7)波形弯曲并且设有第一连接斜撑(9)和第二连接斜撑(10)，其中每一连接斜撑(9、10)具有一个沿撑架(2)的圆周方向延伸的腰(11)，该腰在两侧经由轴向部分(12、13或1 4、15)连接在一个过渡部分(8)上，并且第一连接斜撑(9)的轴向部分(12、13)波形弯曲并且轴向部分(12、13)的横向于轴向部分(12、13)的纵轴线(Lv)测量的宽度(Bv)从腰(11)开始向各过渡部分(8)的方向加大。
2.按照权利要求1所述的支架，其特征在于，腰(11)设置在两个以轴向间距(a)邻接的环形分段(3、4或4、5)之间。
3.按照权利要求1或2所述的支架，其特征在于，第一连接斜撑(9)总是从一个环形分段(3)的两个相互连接的分段斜撑(6、7)的最凹处(18)延伸到一个邻接的环形分段(4)的两个相互连接的分段斜撑(6、7)的最凹处(19)。
4.按照权利要求1至3之一项所述的支架，其特征在于，第二连接斜撑(10)总是从一个环形分段(4)的两个相互连接的分段斜撑(6、7)的尖端(20)一直延伸到一个邻接的环形分段(5)的两个相互连接的分段斜撑(6、7)的尖端(21)。
5.按照权利要求1至4之一项所述的支架，其特征在于，第一连接斜撑(9)和第二斜撑(10)沿圆周方向(U)位错地设置在各环形分段(3、4或4、5)之间。
6.按照权利要求1至5之一项所述的支架，其特征在于，每一第三端的过渡部分(8)在端侧的环形分段(3)上具有一个相对于各邻接的过渡部分(8)轴向凸出的加宽的顶端(22)。

Claims (8)

1.用于设置在一个体内器管内的支架，具有一个包括若干轴向连续不断的环形分段(3-5)的管状的撑架(2)，所述环形分段由各经由各过渡部分(8)连续相互连接的分段斜撑(6、7)构成并且各邻接的环形分段(3-5)通过各连接斜撑(9、10)相连接，其特征在于，各分段斜撑(6、7)波形弯曲并且每一分段斜撑(6、7)的横向于斜撑纵轴线测量的宽度(Bs)从其中间的区域(16)开始向各过渡部分(8)的方向加大。
2.按照权利要求1所述的支架，其特征在于，设有第一连接斜撑(9)和第二连接斜撑(10)，其中每一连接斜撑具有一个沿撑架(2)的圆周方向延伸的腰(11)，该腰在两侧经由轴向部分(12、13或14、15)连接在一个过渡部分(8)上。
3.按照权利要求2所述的支架，其特征在于，第一连接斜撑(9)的轴向部分(12、13)波形弯曲并且轴向部分(12、13)的横向于轴向部分(12、13)的纵轴线(Lv)测量的宽度(Bv)从腰(11)开始向各过渡部分(8)的方向加大。
4.按照权利要求2或3所述的支架，其特征在于，腰(11)设置在两个以轴向间距(a)邻接的环形分段(3、4或4、5)之间。
5.按照权利要求2至4之一项所述的支架，其特征在于，第一连接斜撑(9)总是从一个环形分段(3)的两个相互连接的分段斜撑(6、7)的最凹处(18)延伸到一个邻接的环形分段(4)的两个相互连接的分段斜撑(6、7)的最凹处(19)。
6.按照权利要求2至5之一项所述的支架，其特征在于，第二连接斜撑(10)总是从一个环形分段(4)的两个相互连接的分段斜撑(6、7)的尖端(20)一直延伸到一个邻接的环形分段(5)的两个相互连接的分段斜撑(6、7)的尖端(21)。
7.按照权利要求2至6之一项所述的支架，其特征在于，第一连接斜撑(9)和第二斜撑(10)沿圆周方向(U)位错地设置在各环形分段(3、4或4、5)之间。
8.按照权利要求1至7之一项所述的支架，其特征在于，每一第三端的过渡部分(8)在端侧的环形分段(3)上具有一个相对于各邻接的过渡部分(8)轴向凸出的加宽的顶端(22)。
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CN114533355A (zh) * 2020-11-19 2022-05-27 上海鸿脉医疗科技有限公司 一种医用支架

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DE102004022044B4 (de) 2008-12-18
EP1744706A1 (de) 2007-01-24
KR20060082878A (ko) 2006-07-19
JP2007535391A (ja) 2007-12-06
CA2546095C (en) 2009-12-01
DE102004022044A1 (de) 2005-12-01
AU2005237199A1 (en) 2005-11-10
ES2345557T3 (es) 2010-09-27
ATE466556T1 (de) 2010-05-15
CA2546095A1 (en) 2005-11-10
US20080154353A1 (en) 2008-06-26
KR100820008B1 (ko) 2008-04-08
JP4662982B2 (ja) 2011-03-30
WO2005104990A1 (de) 2005-11-10
US7645297B2 (en) 2010-01-12
EP1744706B1 (de) 2010-05-05
AU2005237199B2 (en) 2008-07-31

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