CN101374482B - 腔内支架 - Google Patents
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- CN101374482B CN101374482B CN2006800529377A CN200680052937A CN101374482B CN 101374482 B CN101374482 B CN 101374482B CN 2006800529377 A CN2006800529377 A CN 2006800529377A CN 200680052937 A CN200680052937 A CN 200680052937A CN 101374482 B CN101374482 B CN 101374482B
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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
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
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- A—HUMAN NECESSITIES
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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
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- A—HUMAN NECESSITIES
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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
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- 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
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- 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
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- 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
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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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- A61F2/91—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
- A61F2002/91516—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 the meander having a change in frequency along the band
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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
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- 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
- A61F2002/91525—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 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
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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
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- 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
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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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Abstract
一种腔内支架(500),包括:管状体(502),适于从坍缩状态转变为扩展或部分扩展状态,所述管状体(502)沿着纵轴线(504)展开。多个盘绕件(506a-506d、508a-508e、510a-510d)或者闭合迂回路径基本上沿着周向展开,所述盘绕件的每一个包括臂部或臂(511)以及弯曲部或弯曲(512),所述弯曲(512)将两个顺序的臂(511)连接起来。当所述支架坍缩以及当所述支架扩展或部分扩展时,朝向相邻盘绕件的弯曲(512)都相对于邻近盘绕件的对应且相对的弯曲(512)周向偏移。第一部分(506、510)包括通过至少一个桥(514a)互相连接的至少两个相邻的盘绕件、不通过桥连接的至少一对弯曲,所述至少一对弯曲设置在两个盘绕件之间最短纵向距离处。第二部分(508)包括至少通过桥(514b)互相连接的两个相邻的盘绕件,所述桥(514b)的数量等于所述在两个盘绕件之间最短纵向距离处的两个盘绕件的弯曲对的数量。
Description
技术领域
本发明的目的是一种腔内支架,用于人体的通道和导管,例如用于恢复因狭窄这样的疾病而变窄或堵塞的血管中的畅通。
本发明的腔内支架特别适用于分叉附近,主要是颈动脉分支附近。
本发明还涉及一种能够自扩展的腔内支架,例如用超弹性材料或诸如镍钛诺的形状记忆材料制成。
本发明还涉及一种腔内支架,设置有用于其的快速定位(prompt location)的装置,例如通过放射线透视方法。
背景技术
腔内支架,特别是自扩展类型的腔内支架,例如从US-A-4665771、US-A-4665905、US-A-4925445、EP-A-0928606、或者WO2005/104991、以及US 2004/0243216A1获知。
这些腔内支架,尽管在许多方面是可接收的,特别是其极大的挠性和弹性,使它们能够在坍缩状态下容易地布置在狭窄而曲折的通道中,但是当扩展时,有些情况下它们不完全适合于支撑血管壁,以便保持适当的畅通管腔供血液通过。
此外,有些情况下这种已知支架的复杂几何形状可能有害,因为它会挂在血管壁上或夹紧血管壁,促使再形成堵塞,例如斑块和狭窄。
特别是在颈动脉中,腔内支架必须在其中央部分保证相当的径向强度,或者一般地,在布置于狭窄处的部分保证相当的径向强度。此外,主要在端部,或者一般地,在布置于狭窄之外的部分,必须用尽可能少的材料制作腔内支架。实际上已经估计到金属和动脉的比例必须保持在准确确定的限度也就是约15%内。太大的值导致再狭窄和高机械刚度。
发明内容
本发明的核心问题是提供一种腔内支架,其结构和功能特性能够克服参照现有技术提及的缺陷并满足所述要求,从而针对这两者获得最好的结果。
该问题通过如权利要求1所述的腔内支架得以解决。
在从属权利要求中描述了进一步的实施例。
附图说明
通过下面参照附图对优选实施例的描述,根据本发明的支架的其它特点和优点将变得显而易见,对于优选实施例的描述仅仅是示例性和非限制性的,附图中:
图1示出根据本发明的腔内支架的可能实施例的平面展开,所示为坍缩或未扩展状态;
图2和图3示出图1支架的变型实施例的平面展开,所示为坍缩或未扩展状态;
图4示出图1支架处于扩展状态的透视图;
图4a示出图4中细节的放大图;
图5示出图4支架的可能变型实施例的透视图;
图6a至图6c分别示出图5支架的末梢部分、中间部分和近处部分的放大细节;
图7a示出与现有技术的支架相比,根据图5的两个支架的末梢部分、中间部分和近处部分的径向压力(N)的图示;
图8示出有利应用根据本发明的支架的颈动脉部分。
具体实施方式
参照上述附图,通常用500表示腔内支架,例如用于活体导管或血管的自扩展类型的支架,特别是用于颈动脉分叉处的支架。
根据本发明的一般实施例,腔内支架包括管状体502,适于从坍缩状态转变为扩展或部分扩展状态(图4或图5)。
“坍缩状态”表示当支架被收缩从而具有比工作使用状态下更小的体积的状态,例如管状体502具有比工作使用状态下更小的尺寸或外径的状态。例如,当容纳或排列在适于沿着导管或血管移动到待处理区域的传输和传送装置上时,支架设置为坍缩状态。例如,在自扩展支架的情况下,它容纳在鞘中,以便保持坍缩状态。
“扩展或部分扩展状态”表示支架不受限制的状态或工作使用状态,并且在该“展开或部分展开状态”下,支架扩展,紧靠导管或血管壁的内表面产生压力接触(图4或图5)。
管状体502沿着纵轴线504展开。
“纵轴线”例如表示圆柱体的对称轴线或者管状体的伸展轴线方向。
管状体502包括基本上沿着周向展开的多个盘绕件506a-506d、508a-508e、510a-510d或者闭合迂回(meander)路径。
“盘绕件”表示环绕伸展的主方向Z字形/来回展开的部件。
每个所述盘绕件包括臂部或臂511。
每个所述盘绕件包括弯曲部或弯曲512,该弯曲部或弯曲512连接两个顺序(subsequent)的臂511,形成所述迂回路径。
更有利的是,当支架坍缩以及当支架扩展或部分扩展时,朝向相邻盘绕件的弯曲512相对于相邻盘绕件的相应且相对的弯曲512周向偏移。
换而言之,考虑对应于一个节距的第一盘绕件的管,相邻的盘绕件偏移X直到约半个节距(图4)。对于半个节距的偏移,两个盘绕件相对于它们之间的中央圆周线基本上镜像对称。
根据可能实施例,通过弯曲来连接臂,以便沿着相应盘绕件的周向形成一系列峰和谷。对于半个节距的偏移,限定峰512a的第一盘绕件的弯曲对应于限定谷512b的相邻盘绕件的弯曲,“峰”和“谷”表示盘绕件基本上正弦的展开(图4a)。两个相邻盘绕件的两个对应的峰和谷限定位于两个盘绕件之间最短纵向距离处的一对弯曲。
优选地,主纵向延伸部的至少一个桥514a-514c将两个相邻的盘绕件连接起来。特别地,在两个盘绕件之间最短纵向距离处的一对弯曲处,桥将两个相邻的盘绕件连接起来。
优选地,将相邻盘绕件连接起来的至少一个桥514a-514c基本上直线地延伸。
优选地,盘绕件分组为至少两个部分,506和510以及508,它们沿着纵轴线504排列,其中第一部分506或510包括通过至少一个桥514a互相连接的至少两个相邻的盘绕件。在第一部分506或510中,在两个相邻盘绕件之间最短纵向距离处的至少一对弯曲不通过桥连接。
第二部分508包括至少两个相邻的盘绕件,这两个相邻的盘绕件通过桥514b互相连接,桥514b的数量与两个盘绕件之间最短纵向距离处的两个盘绕件的弯曲对的数量相同。换而言之,通过相应的桥514b,将第一盘绕件朝向相邻盘绕件的所有弯曲都连接到相邻盘绕件朝向第一盘绕件的所有弯曲。
优选地,第一部分是腔内支架的末梢部分和/或近端部分,而第二部分是腔内支架的中间部分。
图1的实例包括三个部分,分别是两个第一部分506、510和一个第二部分508。
标记为506的端部包括用506a-506d表示的盘绕件,且对应于上述第一部分。实际上,沿着纵轴线504的两个相邻盘绕件(例如盘绕件506a和盘绕件506b)通过至少一个桥514a互相连接。两个相邻的盘绕件506a和盘绕件506b之间最短纵向距离处的若干对弯曲不通过桥连接。图1的实例中设置有三个桥514a,它们将第一部分506的两个相邻盘绕件(506a和506b、或者506b和506c、或者506c和506d)连接起来。此外,在周向上两个接连的桥514a之间设置5对弯曲,这5对弯曲设置在两个相邻盘绕件之间最短纵向距离处,且不通过桥连接。考虑周向上在两个接连的桥514a之间的臂和弯曲,获得单元或周界,该单元或周界包括至少一对弯曲(在图1的情况下是5对),这些弯曲对设置在两个相邻盘绕件之间最短纵向距离处,不且通过桥连接(图4中,所述单元或周界限定虚线区域A1)。
再参照图1,标记为506的部分为端部(既能够是近端部分,也可以是末梢部分,因为扩展形态的支架基本上为圆柱形构造)。
此外,图1中的支架还包括另一个第一部分,如上所述,由标记为510的端部限定,包括标记为510a-510d的盘绕件。能够将上面参照图1的部分506的描述适用于标记为510a-510d的盘绕件。两个相邻盘绕件(例如盘绕件510c和盘绕件510d)之间相应的桥标记为514a。另外在此情况下,标记为510的部分是端部(既可以是近处部分,也可以是末梢部分,因为扩展形态的支架基本上为圆柱形构造)。参照图4,用A2来标示由在周向上两个接连的桥514a之间限定的单元或周界包围的区域,该区域包括位于两个相邻盘绕件之间最短纵向距离处的至少一对弯曲(在图1或图4的情况下为5对),且这些弯曲对不通过桥连接。
根据普通术语所述,图1的支架还包括标记为508的部分,该部分依次包括标记为508a-508e的盘绕件。这个508部分对应于上述的第二部分。实际上,沿着纵轴线504的两个相邻盘绕件(例如盘绕件508a和盘绕件508b)通过桥514b互相连接,该桥514b的数量与两个盘绕件之间最短纵向距离处的两个盘绕件的弯曲对的数量相同。换而言之,第一盘绕件508a朝向相邻盘绕件的弯曲被连接到相邻盘绕件508b的朝向第一盘绕件508a的所有弯曲。
在图1的情况下,部分508是腔内支架的中间部分,夹在端部506与端部510之间。
考虑周向上两个接连的桥514b之间的臂和弯曲,获得单元或周界,该单元或周界包括四个臂(其中两个臂属于两个相邻盘绕件中的一个,而另外两个臂属于两个相邻盘绕件中的另一个)、一对弯曲以及两个桥514b(在图4中,所述单元或周界限定虚线区域A3),这一对弯曲设置在两个相邻盘绕件之间最长纵向距离处。
图2与图1所述的基本上相似,不同之处在于,限定第一部分的端部506、也限定第一部分的端部510和限定第二部分的中间部分508分别包括四个盘绕件506a-506d、510a-510d、508a-508d。
图3也与图1所述基本上相似,不同之处在于,限定第一部分的端部506和也限定第一部分的端部510分别包括三个盘绕件506a-506c、510a-510c,而限定第二部分的中间部分508包括四个盘绕件508a-508d。
图4示出扩展形态下的图1的支架,而图5示出扩展形态下的支架,该支架虽然与图1的支架具有相同的各部分和盘绕件的设置,但是为截锥形状。
根据可能实施例,通过桥514c将第一盘绕件部分和第二盘绕件部分连接起来,桥514c连接两个盘绕件之间最短纵向距离处的弯曲对,每个弯曲是上述两个部分其中一个的一部分。优选地,将第一部分和第二部分连接起来的桥514c的数量包括在将第一部分的两个相邻盘绕件连接起来的桥514a的数量与将第二部分的两个相邻盘绕件连接起来的桥514b的数量之间。根据可能实施例,将第一部分和第二部分连接起来的桥514c的数量大约是将第一部分的两个相邻盘绕件连接起来的桥514a的数量的两倍。
参照图1,用514c标记将端部506和中间部分508(具体而言是盘绕件506d和盘绕件508a)连接起来的桥以及将中间部分508和另一端部510(具体而言是盘绕件508e和盘绕件510a)连接起来的桥。优选地,桥514c的数量包括在将第一部分(端部506或510)的两个相邻盘绕件连接起来的桥514a的数量与将第二部分(或中间部分508)的两个相邻盘绕件连接起来的桥514b的数量之间。优选地,如图1所示,将第一部分和第二部分连接起来的桥514c的数量大约是将第一部分的两个相邻盘绕件连接起来的桥514a的数量的两倍(六个)。
图2和图3在连接的这个方面相似。
根据可能实施例,第一部分506或510包括至少两个、优选至少三个盘绕件,而将两个相邻盘绕件连接起来的桥514a沿着纵向相对于紧随其后的桥周向偏移。这种设置的实例在图1至图3示出,例如参照将盘绕件506a和506b连接起来的桥,该桥相对于紧随其后的将盘绕件506b和506c连接起来的桥周向偏移。510部分具有相似的设置。
优选地,第一部分是腔内支架的近处部分,并包括至少一个标志或者不透射线的部件518。此外,第一部分也是腔内支架的末梢部分,并包括至少一个标志或者不透射线的部件518。
优选地,腔内支架包括设置为第一部分的近处部分506、设置为第二部分的中间部分508、以及设置为第一部分的末梢部分510。优选地,在坍缩状态和扩展状态下,近处部分、中间部分和末梢部分的每一个大约展开腔内支架长度的三分之一。
根据可能实施例,支架包括设置为第一部分的近处部分506、设置为第二部分的中间部分508、以及设置为第一部分的末梢部分510。此外,末梢部分510和近处部分506分别包括四个盘绕件,而中间部分508包括五个盘绕件(图1)。
根据不同实例,支架包括设置为第一部分的近处部分506、设置为第二部分的中间部分508、以及设置为第一部分的末梢部分510。此外,末梢部分、中间部分和近处部分分别包括四个盘绕件(图2)。
根据另一个不同的示例性实施例,支架包括设置为第一部分的近处部分506、设置为第二部分的中间部分508、以及设置为第一部分的末梢部分510。此外,末梢部分和近处部分分别包括三个盘绕件,而中间部分包括四个盘绕件(图3)。
特别地,优选设置,支架包括设置为第一部分的近处部分506、设置为第二部分的中间部分508、以及设置为第一部分的末梢部分510,末梢部分和近处部分分别包括的盘绕件的数量小于或等于中间部分的盘绕件的数量。
根据可能实施例,桥514a-514c为直线的,且相对于纵轴线稍微倾斜。优选地,所有的桥相对于纵轴线在同一个方向上倾斜。更优选地,所有的桥互相平行。
根据可能实施例,扩展状态下的支架限定圆柱管状体(图4)。根据不同实施例,扩展状态下的腔内支架限定截锥形管状体(图5)。
根据可能实施例,基本上在周向上测量的桥的宽度是基本上也在周向上测量的臂的宽度的大约两倍。参照支架中所有的桥,也就是参照第一部分、第二部分的桥或者连接两个不同部分的桥,能够有利地观察到这一方面。
在一些示例性实施例中,测量了径向抗压强度(N)。图7a中列出了若干个值。
一般而言,第二部分508能够承受的压力的范围为0.10至0.20N。此外,第一部分506或510能够承受的压力的范围为0.04至0.06N。
例如,图7a涉及直径为6-9mm且长度为30mm的截锥形管状体。第一值A对应于现有技术(径向力沿纵向没有区别)。其它值B、C、D分别对应于支架的末梢部分、中间部分和近处部分。在本发明的情况下,A=0.10N,B=0.04N,C=0.14N,且D=0.06N。
图6a至图6c示出根据本发明的支架的进一步特性,相对于支架的近处部分506、中间部分508和末梢部分510分别限定为“脚手架(scaffolding)”。这个特性与支架的几何形状及其支撑能力有关。通过测量单元内最大内切圆的直径,能够表示这个特性。对于第一部分这个值为约2mm,而对于第二部分这个值为约1mm。值越小,盘绕件越靠近,因此支撑能力增加。
所述构造允许获得金属伸展部分与动脉的最佳比例,这个比例用百分比表示。优选地,参照上述实例,端部中用百分比表示的这个值相同,而在中间部分不同。近处部分和末梢部分的该值较低。中间部分的该值稍大,但是,这个值小到足以避免支架材料与血管组织之间出现宽的接触区域。
此外,关于挠性,表示弯曲能力并在不破坏的情况下呈现为圆形,已经观察到第二部分(中间部分)优选刚性更大,而第一部分(端部或者末梢部分和近处部分)挠性更大。这允许支架更易于被引导到要植入的位置。
本发明还涉及上述腔内支架的使用,该腔内支架能够植入分叉处,特别是植入颈动脉中的分叉处。处于扩展状态的支架能够具有截锥形状,且周长比相对的近处部分更小的支架的末梢部分被设置在分叉处。
根据实施例,所述支架500制成为单体。例如,通过切割管状部件来获得所述体502,优选通过激光切割来获得所述体502。
优选地,所述体由超弹性材料制成。根据不同实施例,所述体由应变硬化伪弹性材料制成。换而言之,能够使用退火后在室温下(Af<15摄氏度)处于奥氏体状态的材料,然后对这种材料进行充分的应变硬化,例如大于30%,允许获得变形后后的3%-4%的弹性恢复。优选地,施加50%的应变硬化。
根据实施例,所述体502由形状记忆材料制成。
优选地,所述体由镍钛诺、或者基于镍和钛的合金制成,该基于镍和钛的合金例如镍的标称(nominal)重量百分比为55.8%。
例如,能够使用当处于退火或应力释放状态下时具有奥氏体向马氏体相变的材料,在该材料加热期间,在转变到奥氏体结束时的最高温度或者Af低于15摄氏度。
根据实施例,为了形成标志518,第一个盘绕件506a和/或最后一个盘绕件510d包括限定槽或套(housing)522的至少一个框架521。框架521设置在两个臂之间的弯曲处。特别地,框架521和槽522能够被设置为代替与沿着纵轴线紧邻的盘绕件相关的至少两个臂和一个弯曲。
根据可能实施例,第二盘绕件和第三盘绕件包括同样数量的臂和同样数量的弯曲。
优选地,框架521和槽522被设置在两个臂之间的弯曲处,代替与第二盘绕件或第三盘绕件相关的四个臂和三个弯曲。优选地,当腔内支架处于坍缩状态时,如果沿着周向测量,框架521占据被替换臂和弯曲清除(cleared)的全部宽度。
根据可能实施例,槽或套522全部贯穿管状体502的厚度。
优选地,框架521设置在直接连接到框架521的两个臂之间的弯曲的凹部中。
根据可能实施例,通过切割例如激光切割管状体502的圆柱壁,支架作为单体由管状体502形成。
优选地,框架521在通过激光切割圆柱壁获得的管状体502中作为单体形成。
根据可能实施例,槽522在支架的纵轴线方向上具有细长的形状,优选为椭圆形或具有圆边的矩形。优选地,框架521在支架的纵轴线方向上具有细长的形状。优选地,当在支架的平面展开中考虑时,与直接连接到框架的两个臂之间的弯曲对应的框架521的短边在周向上基本上是直线的。
优选地,直接连接到框架521的两个臂在端点处连接到框架。
优选地,框架521包括两个细长的边523,如果沿着周向测量,该细长的边523的宽度与支架的臂511的宽度基本上相同,如果沿着纵向504测量,则该细长的边523的长度比支架的臂511的长度短。
优选地,在槽522中设置不透射线的材料,优选地焊接或熔接在槽中。不透射线的材料可以是比用于支架的材料对X射线的可见度更大的任何材料。
在支架由超弹性材料或形状记忆材料例如镍钛诺(或者以镍和钛作为主要成分的合金)制成的情况下,能够从钽、金、铂、钨或者适于所述目的并且明显生物相容的其它材料中选择不透射线的材料。
根据可能实施例,容置框架521的第一盘绕件506a是支架的端部盘绕件。优选地,支架的两个端部盘绕件,即第一个和最后一个盘绕件,分别包括至少一个框架521。
根据上述,可以理解提供根据本发明的腔内支架如何能够满足像在支架中间部分对径向压力具有高强度而同时避免在该区域过度增加材料用量的对立要求。
此外,在边上获得高度的挠性,同时在中间部分保持更加无形变的形状。
这些方面对于颈动脉特别有利,颈动脉因为其位置而可能受到冲击或压迫。实际上,根据本发明的支架保证颈动脉通道即使在受到冲击或压迫的情况下也保持开放,因为在颈动脉形变后支架至少在其中间部分承受压力,从而保证通道内腔。
因为提供的支架,所以能够在曲折的血管或导管中进行腔内操作,并且同时,当支架处于扩展状态时,还能够保证所处理的血管壁获得最佳的、稳定的支撑。
特别有利的是标志的设置和形状,标志使得支架可见且易于定位,而不干扰相关的精细几何形状,该相关的精细几何形状被适当设计以保证获得上述结果。
应当理解,对上文描述并示出的结构可进行变型和/或提供添加。
盘绕件、臂或弯曲的数量可与上文描述并示出不同。盘绕件的形状也可以变化。
通常上述所有的可能实施例在缺少被描述成属于其它可能实施例的那些特征的情况下也能够被实现。
根据可能实施例,能够用涂覆材料覆盖支架,涂覆材料例如PTFE、生物可降解材料、聚酯纤维、聚亚安酯等等。
对于上述的腔内支架的优选实施例,旨在满足偶然和特殊的要求,本领域技术人员能够用其他功能等效来进行部件的许多修改、变化和替换,而不脱离以下权利要求的范围。
Claims (18)
1.一种腔内支架(500),包括:
管状体(502),适于从坍缩状态转变为扩展状态,
所述管状体(502)沿着纵轴线(504)展开,
所述管状体(502)包括沿着基本上的周向展开的多个盘绕件(506a-506d、508a-508e、510a-510d),
所述盘绕件的每一个包括臂(511)以及弯曲(512),所述弯曲(512)将两个顺序的臂(511)连接起来,以形成所述盘绕件,其中,
当所述支架坍缩以及当所述支架扩展时,朝向相邻盘绕件的所述弯曲(512)都相对于所述相邻盘绕件的对应且相对的弯曲(512)周向偏移,其中
至少一个桥(514a-514c)具有主纵向延伸部,所述桥在两个盘绕件之间最短纵向距离处设置的两个相应的弯曲(512a、512b)处将两个相邻的盘绕件连接起来,其中
所述盘绕件分组为沿着所述纵轴线(504)设置的至少两个部分(506、508、510),其中
第一部分(506、510)包括由至少一个桥(514a)互连的至少两个相邻的盘绕件、不由桥连接的至少一对弯曲,所述至少一对弯曲在两个所述盘绕件之间的最短纵向距离处,以及其中
第二部分(508)包括通过桥(514b)互相连接的至少两个相邻的盘绕件,所述桥(514b)的数量等于所述两个盘绕件之间最短纵向距离处的所述两个盘绕件的弯曲对的数量。
2.如权利要求1所述的腔内支架,其中,所述第一部分(506、510)是所述腔内支架的末梢部分和/或近处部分,而所述第二部分(508)是所述腔内支架的中间部分。
3.如权利要求1或2所述的腔内支架,其中,所述第一部分(506、510)和所述第二部分(508)通过桥(514c)连接,所述桥(514c)将设置在两个盘绕件之间最短纵向距离处的所述两个盘绕件的弯曲对连接起来,每个弯曲是所述两个部分其中一个的一部分。
4.如权利要求3所述的腔内支架,其中,将所述第一部分(506、510)和所述第二部分(508)连接起来的所述桥(514c)的数量包括在将所述第一部分(506、510)的两个相邻盘绕件连接起来的桥(514a)的数量与将所述第二部分(508)的两个相邻盘绕件连接起来的桥(514b)的数量之间。
5.如权利要求1-2中任一项所述的腔内支架,其中,所述第一部分(506、510)包括至少三个盘绕件(506a-506c),其中,将两个相邻盘绕件连接起来的桥(514a)相对于按照纵轴线(504)紧随其后的桥(514a)周向偏移。
6.如权利要求1-2中任一项所述的腔内支架,其中,所述第一部分(506、510)是所述腔内支架的近处部分,并且包括至少一个标志(518),其为不透射线的部件。
7.如权利要求1-2中任一项所述的腔内支架,其中,所述第一部分(506、510)是所述腔内支架的末梢部分,并且包括至少一个标志(518),其为不透射线的部件。
8.如权利要求1-2中任一项所述的腔内支架,包括设置为所述第一部分的近处部分(506)、设置为所述第二部分的中间部分(508)、以及设置为所述第一部分的末梢部分(510),其中,在坍缩状态和扩展状态下,所述近处部分、中间部分和末梢部分的每一个都展开所述腔内支架长度的大约三分之一。
9.如权利要求1-2中任一项所述的腔内支架,包括设置为所述第一部分的近处部分(506)、设置为所述第二部分的中间部分(508)、以及设置为所述第一部分的末梢部分(510),其中,所述末梢部分和所述近处部分分别包括四个盘绕件,而所述中间部分包括五个盘绕件。
10.如权利要求1至2中任一项所述的腔内支架,包括设置为所述第一部分的近处部分(506)、设置为所述第二部分的中间部分(508)、以及设置为所述第一部分的末梢部分(510),其中,所述末梢部分和所述近处部分分别包括三个盘绕件,而所述中间部分包括四个盘绕件。
11.如权利要求1至2中任一项所述的腔内支架,包括设置为所述第一部分的近处部分(506)、设置为所述第二部分的中间部分(508)、以及设置为所述第一部分的末梢部分(510),其中,所述末梢部分和所述近处部分分别包括的盘绕件的数量小于或等于所述中间部分的盘绕件的数量。
12.如权利要求1-2中任一项所述的腔内支架,在所述扩展状态下限定圆柱管状体。
13.如权利要求1至2中任一项所述的腔内支架,在所述扩展状态下限定截锥形管状体。
14.如权利要求1-2中任一项所述的腔内支架,包括涂覆材料。
15.如权利要求14所述的腔内支架,其中所述涂覆材料为PTFE。
16.如权利要求14所述的腔内支架,其中所述涂覆材料为生物可降解材料。
17.如权利要求14所述的腔内支架,其中所述涂覆材料包括聚酯纤维。
18.如权利要求1-2中任一项所述的腔内支架,其中,基本上在周向上测量的所述桥(514a、514b、514c)的宽度是基本上也在周向上测量的所述臂(511)的宽度的大约两倍。
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PCT/IT2006/000086 WO2007094020A1 (en) | 2006-02-17 | 2006-02-17 | Endoluminal prosthesis |
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EP (1) | EP1983946B1 (zh) |
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CN (1) | CN101374482B (zh) |
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CA (1) | CA2634604C (zh) |
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MX (1) | MX2008010615A (zh) |
NZ (1) | NZ569760A (zh) |
WO (1) | WO2007094020A1 (zh) |
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- 2006-02-17 JP JP2008554912A patent/JP5544614B2/ja active Active
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- 2006-02-17 CN CN2006800529377A patent/CN101374482B/zh not_active Expired - Fee Related
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EP0888757A1 (de) * | 1997-06-30 | 1999-01-07 | Corotec Medizintechnik GmbH | Intraluminales Implantat |
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WO2007094020A1 (en) | 2007-08-23 |
NZ569760A (en) | 2011-01-28 |
AU2006338440A1 (en) | 2007-08-23 |
EP1983946A1 (en) | 2008-10-29 |
JP5544614B2 (ja) | 2014-07-09 |
CA2634604A1 (en) | 2007-08-23 |
MX2008010615A (es) | 2009-01-13 |
AU2006338440B2 (en) | 2012-10-25 |
KR20080100419A (ko) | 2008-11-18 |
KR101290499B1 (ko) | 2013-07-26 |
US20090069882A1 (en) | 2009-03-12 |
ATE526914T1 (de) | 2011-10-15 |
CN101374482A (zh) | 2009-02-25 |
EP1983946B1 (en) | 2011-10-05 |
JP2009526595A (ja) | 2009-07-23 |
IL192543A (en) | 2012-06-28 |
BRPI0621358A2 (pt) | 2011-12-06 |
CA2634604C (en) | 2013-09-10 |
BRPI0621358B8 (pt) | 2021-06-22 |
US8778010B2 (en) | 2014-07-15 |
IL192543A0 (en) | 2009-09-22 |
BRPI0621358B1 (pt) | 2018-02-06 |
WO2007094020A8 (en) | 2007-11-08 |
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