CN101902992A - 模块化支架组件 - Google Patents
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Abstract
本发明涉及包括至少第一支架(1’)和第二支架(1”)的组件(10)。每个支架包括近端部分(2)、中央部分(3)和远端部分(4)。近端部分和远端部分提供了基本上等于由中央部分提供的径向力的一半的径向力。因此，通过使第二支架(1”)的远端部分(4”)与第一支架(1’)的近端部分(2’)重叠，使得由重叠部分提供的径向力近似等于由两个支架的中央部分(3’，3”)提供的径向力。
Description
技术领域
本发明涉及模块化支架组件，即腔内假体的组件，所述组件的数个例子可串联地植入到单条血管内。
背景技术
已知支架的使用为由于疾病和/或例如狭窄的损伤而趋向于阻塞的血管壁提供内支承。以折叠状态引入血管内部的支架，在受狭窄影响的长度内呈现扩展状态。为了对血管壁提供合适的支承，支架需要施加预设的取向向外的径向力。此径向力的程度是支架的设计准则之一。
在一些情况中，疾病影响的血管长度过长而超过了单个支架的长度。在此情况中，可将已知类型的多个支架串联植入，但此解决方法并非没有缺点。
实际上，单个支架设计为分开地植入。为此原因，支架必须提供的径向力在设计步骤中基于血管要求来确定。
多个串联的支架的植入能够通过相邻支架的并置或部分重叠来实现。
在并置的情况中，操作变得极为困难，因为要求通常难于实现的精度。因此，此解决方法导致了在两个相邻的支架之间留有间隙的实际风险，因此遗留了没有任何支承的血管长度。因此，这样的血管长度必将紧缩，这可能再次减少血管截面，因此影响手术效果。
相反，两个相邻支架的部分重叠，则在这些支架重叠的血管长度内，产生两倍于设计径向力的径向力。
发明内容
因此，本发明的目的是至少部分地解决前面参考现有技术阐述的问题。
这样的问题通过根据权利要求1的支架组件解决。
附图说明
本发明的另外的特征和优点将从在此通过非限制性例子参考如下附图给出的一些例示实施例的描述中得到更清楚地理解，在所有附图中：
图1示意性地示出了根据本发明的处于分开的构造和重叠的构造中的支架组件，其中每个构造伴有相应的径向力图示；
图2示意性地示出了沿图1中的任意线II-II的截面；
图3示意性地示出了沿图1中的线III-III的截面；
图4示出了根据本发明的支架的平面展开；
图5示出了根据本发明的支架的平面展开；
图6示出了由根据本发明的支架在端部处和在中央部分处所提供的径向力的图示；
图7示意性示出了根据本发明的支架的平面展开；
图8示意性示出了根据本发明的支架的平面展开；
图9示意性示出了根据本发明的支架的平面展开。
具体实施方式
参考附图，根据本发明的支架以附图标号1表示，而至少第一支架1’和第二支架1”的组件一般地以附图标号10表示。
支架1的类型是本质上广泛地已知的所谓自扩展类型。即，所述支架1由形状记忆合金(例如，镍钛诺)制成，所述形状记忆合金允许支架在去除任何径向约束后自发地呈现扩展构造。
支架1沿纵向X-X轴线延伸。因此，平行于X-X轴线的每个方向被称为轴向方向。在此，如下各图的左部分通常被认为表示支架的近端部分，相反各图的右部分通常被认为表示支架的远端部分。
根据本发明的每个支架1包括近端部分2、中央部分3和远端部分4。近端部分2和远端部分4提供了基本上等于由中央部分3所提供的径向力的一半的径向力。因此，通过将第二支架1”的远端部分4”与第一支架1’的近端部分2’重叠，由重叠的部分提供的径向力近似等于由两个支架1’、1”的中央部分3’、3”提供的径向力。
在图6中，提供了由根据本发明的支架1的不同部分施加的平均径向力。柱状图的第一柱和第三柱(标记为“端部”)表示由近端部分2和远端部分4施加的平均径向力相对于由中央部分3施加的平均径向力(第二柱，标记为“中间”)的百分比。
根据实施例，支架1包括多个蛇形部5。每个蛇形部5包括通过多个弯曲部52相互连接的多个支杆51。
在此，在下文中假定支架具有总共n个蛇形部5。通常，蛇形部5将通过顶点来识别，所述顶点指示了从近端端部开始去往远端端部的渐进位置。
每个蛇形部通过连接件50连接到至少一个与之相邻的蛇形部。近端蛇形部51和远端蛇形部5n通过连接件50连接到单个相邻的蛇形部(分别为52和5n-1)，而其他蛇形部5x的每个通过连接件50连接到两个相邻的蛇形部5x-1和5x+1。
根据实施例，根据本发明的支架1包括带有具有沿X-X轴线的不同长度的支杆的蛇形部5。特别地，在近端部分2和远端部分4中，蛇形部5的支杆51比在相同支架1的中央部分3内的蛇形部5的支杆51更长。这样的特征在图7、图8和图9中图示，且在图4中图示。
如将注意到，在图4的实施例中，支架1的近端部分2包括三个蛇形部5。近端蛇形部51具有3.55mm的总轴向延伸(通过对支杆51的轴向长度与弯曲部52的轴向尺寸求和给出)。近端部分2的后续两个蛇形部52和53均具有3mm的总轴向延伸。以非常对称的方式，远端部分4也包括三个蛇形部5。远端蛇形部519具有3.55mm的总轴向延伸。远端部分4的前面两个蛇形部518和517均具有3mm的总轴向延伸。中央部分3的所有蛇形部54+16具有2.454mm的总轴向延伸。
蛇形部5的支杆51的较长长度有助于减少由近端部分2和远端部分4施加的径向力F。
根据实施例，根据本发明的支架1包括沿X-X轴线由不同数目的连接件50连接的蛇形部5。特别地，在近端部分2和远端部分4中，连接件50的数目少于相同支架1的中央部分3内存在的连接件50的数目。这样的特征在图8和图9中示出。
在图8中可见，近端蛇形部51通过三个连接件50连接到后续的蛇形部52，且蛇形部52通过四个连接件50连接到后续的蛇形部53。中央部分3的所有蛇形部5x通过四个连接件50连接，而蛇形部5n-1通过三个连接件50连接到后续的远端蛇形部5n。
在图9中可见，近端蛇形部51通过三个连接件50连接到后续的蛇形部52；蛇形部52通过四个连接件50连接到后续的蛇形部53；且蛇形部53通过五个连接件50连接到后续的蛇形部54。中央部分3的所有蛇形部5x通过五个连接件50连接。蛇形部5n-3通过五个连接件50连接到后续的蛇形部5n-2；蛇形部5n-2通过四个连接件50连接到后续的蛇形部5n-1；蛇形部5n-1通过三个连接件50连接到后续的远端蛇形部5n。
更少数量的连接件50有助于减少由近端部分2和远端部分4施加的径向力F。
根据一些实施例，支架1的近端部分2和远端部分4的径向厚度低于中央部分3的径向厚度。较低的径向厚度有助于减少由近端部分2和远端部分4施加的径向力F。
根据一些实施例，支架1以本质上已知的方式包括由不透射线的材料(例如，钽、金、铂或钨)形成的标记6。实际上，例如镍钛诺的形状记忆合金对于放射透视是几乎透明的，因此不透射线的标记6增加了支架1在受控放射透视的操作期间的可见性。
根据一些实施例，例如在图4中示出的实施例，支架1包括(利用类似于上面已用来识别蛇形部的顶点惯例)：
在支架1的近端处的第一标记61；和
在支架1的远端处的第二标记62。
根据其他实施例，例如在图5中示出的实施例，支架1包括：
在支架1的近端处的第一标记61；
在近端部分2的远端处的第二标记62；
在远端部分4的近端处的第三标记63；和
在支架1的远端处的第四标记64。
根据实施例，例如图4中的实施例，不透射线的标记6具有比典型地使用的标记更大的尺寸。特别地，标记6的轴向延伸是容纳它的蛇形部5的整个轴向延伸的50％以上，优选地65％以上，更优选地70％以上。
例如，在图5的实施例中，与里面容纳了标记6的蛇形部5的3.55mm的轴向延伸相比，标记6具有2.5mm的轴向延伸。因此，标记6的轴向延伸是容纳它的蛇形部5的整个轴向延伸的70％以上。
在图5中示出的支架1的构造在外科手术期间允许以极精确的方式的放射透视地控制第二支架1”的远端部分4”与先前植入的第一支架1’的近端部分2’的重叠。在由第二支架1”的标记64和63标出的轴向位置分别对应于由先前植入的第一支架1’的标记62和61标出的轴向位置时，这样的重叠完成。
根据本发明的组件10的使用方法包括如下步骤：
提供处于折叠构造的第一支架1’；
将第一支架1’沿被损伤影响的患者的血管引入到损伤的远端；
使第一支架1’从折叠构造变成扩展构造；
提供处于折叠构造的第二支架1”；
将第二支架1”沿相同的血管引入到损伤；
将第二支架1”的远端部分4”引入到第一支架1’的近端部分2’内；
使第二支架1”从折叠构造变成扩展构造。
组件10的使用方法能够提供根据模块化逻辑的后续的支架1的布置、引入和扩展的其他步骤，直至达到损伤的近端。
根据方法的一些实施例，将第二支架1”的远端部分4”引入到第一支架1’的近端部分2’内的步骤能够有利地通过使用不透射线的标记6放射透视地控制两个支架1”和1’的相对位置来执行。
本领域一般技术人员应从所阐述的前文中认识到根据本发明的组件10的使用允许先验不确定的扩展的疾病治疗。对于第一支架1的植入，能够在任何长度的血管内继之以不确定数目的其他支架，而不克服希望的径向力。
应认识到的是，仅描述了作为本发明的目的的支架的一些特定实施例，对此本领域一般技术人员将能够执行将其适配用于特定应用所要求的所有修改，而不偏离本发明的保护范围。
Claims (11)
1.一种组件(10)，包括至少第一支架(1’)和第二支架(1”)，每个支架(1)包括近端部分(2)、中央部分(3)和远端部分(4)，其中所述近端部分(2)和远端部分(4)提供了基本上等于由所述中央部分(3)提供的径向力的一半的径向力，使得通过使第二支架(1”)的远端部分(4”)与第一支架(1’)的近端部分(2’)相重叠，由重叠部分提供的径向力近似等于由两个支架(1’、1”)的中央部分(3’，3”)提供的径向力。
2.根据权利要求1所述的组件(10)，其中所述支架(1)包括多个蛇形部(5)，每个蛇形部包括通过多个弯曲部(52)相互连接的多个支杆(51)，且每个蛇形部通过连接件(50)连接到至少一个与之邻近的蛇形部。
3.根据权利要求2所述的组件(10)，其中所述近端部分(2)和远端部分(4)的蛇形部(5)具有比所述支架(1)的中央部分(3)的蛇形部(5)的支柱(51)更长的支柱(51)。
4.根据权利要求2所述的组件(10)，其中所述近端部分(2)和远端部分(4)的蛇形部(5)通过多个连接件(50)连接，所述多个连接件(50)的数目小于对相同的支架(1)的中央部分(3)的蛇形部(5)进行连接的连接件(50)的数目。
5.根据权利要求1所述的组件(10)，其中所述支架(1)的近端部分(2)和远端部分(4)具有小于中央部分(3)的径向厚度。
6.根据权利要求1所述的组件(10)，其中所述支架(1)包括至少一个标记(6)，所述标记(6)由从下述材料组成的组中选择的不透射线的材料制成：钽、金、铂和钨。
7.根据权利要求6所述的组件(10)，其中所述支架(1)包括：
在所述支架(1)的近端端部处的第一标记(61)；和
在所述支架(1)的远端端部处的第二标记(62)。
8.根据权利要求6所述的组件(10)，其中所述支架(1)包括：
在所述支架(1)的近端端部处的第一标记(61)；
在所述近端部分(2)的远端端部处的第二标记(62)；
在所述远端部分(4)的近端端部处的第三标记(63)；和
在所述支架(1)的远端端部处的第四标记(64)。
9.根据权利要求6所述的组件(10)，其中至少一个不透射线的标记(6)的轴向延伸范围是容纳它的蛇形部(5)的总轴向延伸范围的50％以上，优选地65％以上，更优选地70％以上。
10.一种使用根据权利要求1所述的组件(10)的方法，包括如下步骤：
提供处于折叠构造的第一支架(1’)；
将第一支架(1’)沿受损伤影响的患者的血管引入到所述损伤的远端端部；
使第一支架(1’)从折叠构造变成扩展构造；
提供处于折叠构造的第二支架(1”)；
将第二支架(1”)沿相同的血管引入到所述损伤；
将第二支架(1”)的远端部分(4”)引入到第一支架(1’)的近端部分(2’)内；
使第二支架(1”)从折叠构造变成扩展构造。
11.一种支架(1)，包括近端部分(2)、中央部分(3)和远端部分(4)，其中所述近端部分(2)和远端部分(4)提供了基本上等于由所述中央部分(3)提供的径向力的一半的径向力，使得通过使第二支架(1”)的远端部分(4”)与第一支架(1’)的近端部分(2’)相重叠，由重叠部分提供的径向力近似等于由两个支架(1’、1”)的中央部分(3’，3”)提供的径向力。
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/IB2007/004007 WO2009077805A1 (en) | 2007-12-19 | 2007-12-19 | Modular stent assembly |
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| Publication Number | Publication Date |
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| CN101902992A true CN101902992A (zh) | 2010-12-01 |
| CN101902992B CN101902992B (zh) | 2012-11-28 |
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| CN2007801019484A Expired - Fee Related CN101902992B (zh) | 2007-12-19 | 2007-12-19 | 模块化支架组件 |
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| EP (1) | EP2227190A1 (zh) |
| JP (1) | JP2011507570A (zh) |
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| AR (1) | AR070768A1 (zh) |
| TW (1) | TW200930341A (zh) |
| WO (1) | WO2009077805A1 (zh) |
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| US8114149B2 (en) * | 2009-10-20 | 2012-02-14 | Svelte Medical Systems, Inc. | Hybrid stent with helical connectors |
| EP3388032B1 (en) * | 2014-03-18 | 2019-06-26 | Boston Scientific Scimed, Inc. | Reduced granulation and inflammation stent design |
| WO2016006476A1 (ja) * | 2014-07-07 | 2016-01-14 | バンドー化学株式会社 | 研磨フィルム |
| US11628076B2 (en) | 2017-09-08 | 2023-04-18 | Vesper Medical, Inc. | Hybrid stent |
| US11357650B2 (en) * | 2019-02-28 | 2022-06-14 | Vesper Medical, Inc. | Hybrid stent |
| US10271977B2 (en) * | 2017-09-08 | 2019-04-30 | Vesper Medical, Inc. | Hybrid stent |
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| CA2229685C (en) * | 1997-02-27 | 2003-09-02 | Corvita Corporation | Modular endoluminal stent-grafts and methods for their use |
| US5938697A (en) * | 1998-03-04 | 1999-08-17 | Scimed Life Systems, Inc. | Stent having variable properties |
| US6355059B1 (en) * | 1998-12-03 | 2002-03-12 | Medinol, Ltd. | Serpentine coiled ladder stent |
| US6258117B1 (en) * | 1999-04-15 | 2001-07-10 | Mayo Foundation For Medical Education And Research | Multi-section stent |
| US7226475B2 (en) * | 1999-11-09 | 2007-06-05 | Boston Scientific Scimed, Inc. | Stent with variable properties |
| US6610087B1 (en) * | 1999-11-16 | 2003-08-26 | Scimed Life Systems, Inc. | Endoluminal stent having a matched stiffness region and/or a stiffness gradient and methods for providing stent kink resistance |
| JP2006500997A (ja) * | 2002-09-27 | 2006-01-12 | メドロジックス デバイス コーポレイション | 端部を改変された移植可能なステント |
| JP2006505355A (ja) * | 2002-11-07 | 2006-02-16 | アボット・ラボラトリーズ | 可変濃度の有益な薬剤を有するプロテーゼ |
| US7320702B2 (en) * | 2005-06-08 | 2008-01-22 | Xtent, Inc. | Apparatus and methods for deployment of multiple custom-length prostheses (III) |
| BRPI0621358B8 (pt) * | 2006-02-17 | 2021-06-22 | Invatec Srl | prótese endoluminal |
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2007
- 2007-12-19 WO PCT/IB2007/004007 patent/WO2009077805A1/en active Application Filing
- 2007-12-19 EP EP07859122A patent/EP2227190A1/en not_active Withdrawn
- 2007-12-19 JP JP2010538925A patent/JP2011507570A/ja active Pending
- 2007-12-19 US US12/809,232 patent/US20100274348A1/en not_active Abandoned
- 2007-12-19 CN CN2007801019484A patent/CN101902992B/zh not_active Expired - Fee Related
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2008
- 2008-11-21 TW TW097145232A patent/TW200930341A/zh unknown
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| Publication number | Publication date |
|---|---|
| EP2227190A1 (en) | 2010-09-15 |
| US20100274348A1 (en) | 2010-10-28 |
| WO2009077805A1 (en) | 2009-06-25 |
| JP2011507570A (ja) | 2011-03-10 |
| CN101902992B (zh) | 2012-11-28 |
| AR070768A1 (es) | 2010-05-05 |
| TW200930341A (en) | 2009-07-16 |
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