CN101868195A - 可挠支架 - Google Patents
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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
- A61F2/86—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
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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
- A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
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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
- 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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- 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
- A61F2002/91558—Adjacent bands being connected to each other connected peak to peak
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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
- A61F2002/9155—Adjacent bands being connected to each other
- A61F2002/91575—Adjacent bands being connected to each other connected peak to trough
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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
- 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
本发明的支架结合了藉由线圈组件而相互连接的螺旋支撑带。此结构提供了在一支架中令人向往的特性结合,例如,举例而言,坚实的可挠性,支持一脉管腔的稳定性,单元格尺寸,以及径向强度。本发明的支架的结构亦在该螺旋支撑带以及相互连接的线圈组件之间提供了一预定的几何关系三角形,以在该支架的任何直径尺寸状态下维持连接性。
Description
技术领域
本发明一般而言是相关于能够插入活体内的小空间中的可扩展式管状结构,更特别地是,所考虑的是一种支架结构,其几何结构能够在不发生机械错误且不让其几何结构发生实质改变的情形下,在沿着其长度的各点处进行坚实且重复的收缩。
背景技术
支架是一种管状的结构,其能够在径向受压、或卷曲的状态下被插入一活体内受限的空间之中,例如,一输送管,一动脉、或其它的脉管。而在插入之后,支架则可以进行径向的扩张,以扩大其所在位置的空间。通常,支架根据特征不同可分为球囊扩张式(BX,balloon-expanding)、或自展式(SX,self-expanding)。一球囊扩张式支架需要一气囊(其通常是属于一递送系统的一部份)而自脉管内部进行支架扩张,进而使脉管膨胀。该自展式支架则是被设计为其一旦在预期的脉管中被释放以后,可由卷曲的状态扩展成为一已扩张状态(通过材质、几何结构、或制造技术的选择)。在某些情况下,为了要膨胀不健全的脉管,会需要比自展式支架的扩张力更高的力量。则在此情形下,就可以使用一气囊、或类似的装置来帮助一自展式支架的扩张。
典型地,支架会被用来治疗血管以及非血管疾病。举例而言,一卷曲的支架可以被插入一阻塞的动脉之中,然后进行扩张,以恢复该动脉中的血液流动。而在释放之前,该支架则通常会在一导管以及类似者之中维持其卷曲的状态。在完成整个程序之后,支架会以扩张的状态留在病人动脉里。而病人的健康,有时是生命,就是取决于该支架维持其扩张状态的能力。
许多已知的支架在处于其卷曲状态时会为可挠,以让递送支架(举例而言,在一动脉里)的工作变得更为容易,另外,较少的一部份则是在放置及扩张后仍为可挠。然而,在放置之后,于某些应用中,举例而言,当用于支撑股浅动脉(superficial femoral artery)时,一支架可能会在沿着其长度的各点处遭受到实质的收缩、或弯曲力,轴向的压缩,以及反复的移位。而这则是可能会产生剧烈的张力以及疲劳,进而导致支架发生故障。
在类似支架的结构中也有相似的问题。其中一个例子是,与在一以导管为主的瓣膜递送系统(catheter-based valve delivery system)中的其它零件一起使用的一类支架(stent-like)结构。如此的一类支架结构会维持住被设置在一脉管中的一瓣膜。
发明内容
本发明的支架结合了藉由线圈组件而相互连接的螺旋支撑带,此结构提供了在一支架中令人向往的特性结合,例如,举例而言,坚实的可挠性,支持一脉管腔的稳定性,单元格尺寸,以及径向强度,然而,增加用来相互连接该螺旋支撑带的该等线圈组件则是让改变支架的直径状态变得更为复杂。典型地,一支架结构必须要能够改变该支架的直径的大小。举例而言,一支架通常会是在处于一较小直径尺寸状态的情形下被递送至在一动脉中的一目标病灶位置,然后,再于该目标病灶位置处的动脉里扩展为较大直径尺寸状态。而本发明的支架的结构则是在该螺旋支撑带以及相互连接的线圈组件之间提供了一预定的几何关系三角形,以在该支架的任何直径尺寸状态下维持连接性。
本发明的支架是一种由超弹性镍钛诺(superelastic nitinol)所制成的自展式支架。此型态的支架被制造为在完全展开、或未受限的状态下具有一特殊的结构。再者,此型态的支架必须要能够径向地被压缩至一较小的直径,这通常称之为卷曲直径(crimped diameter)。而将一支架径向压缩至一较小直径的情形则通常被称之为卷曲该支架。其中,一自展式支架的完全展开、或未受限直径与该卷曲直径之间的差异可以很大。相当常见的是,该完全展开、或未受限直径是该卷曲直径的3至4倍大。一自展式支架会被设计为,通过材质、几何结构、或制造技术的选择,其一旦在预期的脉管中被释放以后,就可由卷曲的状态扩展成为一展开状态。
本发明的支架包括螺旋地环绕该支架的一轴而进行卷绕的一螺旋支撑带。该螺旋支撑带会包括一波浪型样支撑组件,其在该波浪型样的每一端上具有多个尖峰。多个线圈组件会螺旋地环绕该支架的一轴而进行卷绕,并会以与该螺旋支撑带相同的方向前进。通常,该等线圈组件是瘦长的,亦即,长度比宽度大上许多。该等线圈组件会在该波浪型样的尖峰处、或附近,使一第一绕组的该等支撑组件的至少其中一些与该螺旋支撑带的一第二绕组的该等支撑组件的至少其中一些进行相互连接。在本发明的支架中,一几何关系三角形会被建构为具有一第一边,其支柱长度Lc是在该螺旋支撑带的该等第一以及第二绕组的该等相互连接尖峰间的该线圈组件的有效长度,一第二边,其支柱长度是将藉由该线圈组件而相互连接的该第一绕组的尖峰以及该第二绕组的尖峰之间的圆周距离除以该螺旋支撑部件自该支架的长轴起算的一角度As的一正弦值,一第三边,其支柱长度是该螺旋支撑带前进一个圆周绕组(Pl)的长轴距离减去该有效支撑长度LS,该第一边的一第一角,其是180度减去该角度As,该第二边的一第二角,其是该线圈组件自该长轴起、大致环绕该支架的该轴所前进的角度Ac,以及该第三边的一第三角,其是角度As减去角度Ac,其中,由该第一支柱长度LC对一长度LS的一比率乘上形成该螺旋支撑带的相邻波浪型样支撑组件的数量Ns会大于、或等于约1。此数值被定义为该线圈-支撑率,以数字表示则为线圈-支撑率=Lc/Ls*Ns。
附图说明
本发明于先前所叙述的以及更进一步的目的、特征、以及优势将可以在以所附的附图做为参考的情形下,由接下来的当前较佳、但为依据本发明所举例说明的实施例的详细叙述而获得更完整的了解,其中:
图1显示根据本发明一第一实施例的一支架的一平面图,其中,该支架是显示为部分扩张的状态;
图2是在图1中所显示的A部分的局部放大图;
图3是根据一另一实施例的支架的一平面图;
图4是在图3中所显示的B部分的局部放大图;
图5是根据一另一实施例的支架的一平面图;
图6是根据一另一实施例的支架的一平面图;
图7是根据一另一实施例的支架的一平面图;
图8是在图7中所显示的C部分的局部放大图;
图9是根据一另一实施例的支架的一平面图;以及
图10是根据一另一实施例的支架的一线圈组件的一示意图。
具体实施方式
现在,更详细的参考将会指向本发明的一较佳实施例,在所附的附图中所举例说明的实例。而只要有可能,会在整份附图以及叙述中,将会使用相同的参考符号来代表相同、或类似的部件。
图1以及在图2中所显示的局部结构是在于举例说明支架500。图1是根据本发明一第一实施例的支架500,其在处于部分扩张状态时的一平面图。正如在此所使用的,该词汇“平面图”将可被理解为是叙述一展开的平面图。这可以想象为将一管状的支架沿着其平行轴切开,再将其放置为平铺的状态。应该可以理解的是,在真实的支架中,图1的顶缘将会与下缘结合在一起。支架500包括藉由线圈组件507而相互连接的螺旋状支撑带502。而并排的线圈组件507则是会形成线圈带510。该线圈带510是被形成为与螺旋支撑带502合在一起的一双螺旋,且是由该支架的一端前进至另一端。该螺旋支撑带502会包括一波浪型样的支撑组件503,其在波浪型样的每一侧皆具有尖峰508,并且在尖峰508之间具有支柱509。该等线圈组件507是以穿过、或靠近该等尖峰508的方式而会使螺旋支撑带502的支撑组件503相互连接。螺旋支撑带502的NSC部分505的定义是,当螺旋支撑带502环绕着支架500前进时,螺旋支撑带502在线圈组件507之间的支撑组件503数量(NSC)。而在螺旋支撑带502的NSC部分505中的支撑组件503数量(NSC)则是会比在螺旋支撑带502的一个圆周绕组中的支撑组件503数量(N)更多。在NSC部分505中的支撑组件503数量(NSC)是不变的。
在此实施例中,支架500在螺旋支撑带502的一个圆周绕组中具有N=12.728个螺旋支撑组件503,以及在NSC部分505中具有N=16.5个螺旋支撑组件503。螺旋支撑带502的NSC部分505的CCDn部分512是被相等于NSC减去N的支撑组件503数量(CCDn)所定义。在CCDn部分512中的支撑组件503数量(CCDn)以及在螺旋支撑带502的一个圆周绕组中的支撑组件503数量(N)在支架500处于不同直径尺寸状态时,其并不需要为不变。支架500在CCDn部分512中具有CCDn=3.772个螺旋支撑组件503。由于此连接性需要在任何直径尺寸状态下皆可获得维持,因此,该螺旋支撑带502以及线圈组件507之间的一几何关系会是以几何关系三角形511来进行叙述。该几何关系三角形511具有一第一边516(其支柱长度相等于线圈组件507的有效长度(Lc)503),一第二边513(其支柱长度相等于螺旋支撑带502的CCDn部分512的圆周线圈距离(CCD)531除以螺旋支撑带502自支架500的长轴起算的一角度As 535的一正弦值),一第三边514(其支柱长度(SS)532相等于螺旋支撑带502前进一个圆周绕组的长轴距离(Pl)534减去有效支撑长度LS 533)。该第一边516的一第一角537相等于180度减去角As 535,第二边513的一第二角536相等于线圈组件507自支架500的长轴起算的角Ac 536,以及第三边514的一第三角538相等于角As 535减去角Ac 536。若是螺旋支撑组件503的圆周支撑距离(Ps)539对CCDn部分512中的所有螺旋支撑组件503皆为相同时,则圆周线圈距离CCD 531就会相等于在该CCDn部分512中的螺旋支撑组件503数量乘上该圆周支撑距离(Ps)539。在此,在显示一支架的平面型样的任何附图中,距离所代表的是在该支架的表面上的距离,举例而言,垂直距离是圆周距离,以及有角度的距离是螺旋距离。几何关系三角形511的第一边516被绘制为平行于线圈组件507的直线部分,因而使得该线圈角度Ac 536会等于线圈组件507的该直线部分的角度。若是线圈组件507实质上不具有直线部分,而是以螺旋的方式环绕该支架时,则就可以利用一等效的线圈角度536来建构该几何关系三角形511。举例而言,若是线圈组件507是一波浪状线圈组件907,如图10中所示,则线901就可被绘制为适切地通过该波浪状线圈组件907的曲线,然后再利用线901来定义线圈角度536。
显示在图3以及图4中的支架400类似于支架500,因为其包括藉由线圈组件507而相互连接的螺旋支撑带402。而支架400的不同点则是在于,螺旋支撑带402包括有二个相邻的波浪型样支撑组件403a以及403b,且其于该波浪型样的每一侧皆具有尖峰508。支撑组件403a会连接至支撑组件403b。类似于螺旋支撑带502,螺旋支撑带402亦会具有一NSC部分405以及一CCDn部分412。螺旋支撑带402可以被定义为其支撑组件具有数量Ns等于2的波浪型样,而螺旋支撑带502则是可以被定义为所具有的支撑组件波浪型样数量Ns等于1。于一另一实施例之中,本发明的支架亦可以具有支撑组件的波浪型样数量Ns等于3的一螺旋支撑带,也就是,其是一个三重的支撑带。在一另一实施例之中,本发明的支架也可以具有支撑组件的波浪型样数量Ns等于任何整数的一螺旋支撑带。而具有支撑组件的波浪型样数量Ns等于、或大于2的螺旋支撑带的支架所能提供的优势则是在于,该螺旋支撑带可以形成一具有较小单元格(cell)尺寸的封闭单元格结构,这尤其在具额外栓塞风险时显得有所需要。具有较小单元格尺寸的支架,其捕捉血小板、或是其它潜在栓塞碎片的倾向会比具较大单元格尺寸的支架更好。
所叙述的支架结构,当线圈-支撑率(Lc比上Ls的比率)乘上在该螺旋支撑带中波浪型样支撑组件的数量Ns(Lc乘上Ns,除以Ls)得到大于、或等于1的结果时,其可提供在一支架中令人向往的特性结合。举例而言,支架500的该线圈-支撑率为2.06,以及支架400的该线圈-支撑率为2.02,在图9中所显示的支架200具有类似于支架500的结构。而该支架200的该线圈-支撑率则大约为1.11。
为了让根据本发明的支架能够卷曲至较小的直径,该结构的几何学会经历数种改变。由于螺旋支撑带的螺旋性质,因此,支撑角度As在支架直径减少时必定会变得较小。因为在该螺旋支撑带的一第一绕组以及该螺旋支撑带的一第二绕组之间藉由该线圈组件所造成的相互连接,所以,组件的角度Ac势必也会变得较小、或是变得较浅,以容纳该较小的支撑角As。若是线圈组件的角度Ac在支架发生卷曲以及支撑角As变小时,无法变得较浅、或是在变浅上有困难,则该等线圈组件将会倾向产生相互干扰、并妨碍卷曲的发生,或者将会需要更多的力量来进行卷曲。若该线圈-支撑率大于1时,则将会对该线圈组件在进行卷曲期间的角度改变有所助益。而小于1的线圈-支撑率则是会有让线圈组件变坚硬的倾向,因而使得在该卷曲程序期间,会需要更多的力量来弯曲该线圈组件,这则是不乐见的。
支架600的螺旋支撑带602,如图5中所示,会过渡并延伸为一末端支撑部分622,在此,形成末端支撑部分622的波浪型样支撑组件624a的绕组AT1的角度会大于该螺旋支撑带的角度As。末端支撑部分622会包括波浪型样支撑组件624b的一第二绕组,且该第二绕组的角度AT2会大于该第一绕组AT1的角度。螺旋支撑带602的支撑组件603是藉由定义出过渡线圈部分621的一系列过渡线圈组件623,而与末端支撑部分622的该第一绕组的支撑组件624a相互连接。末端部分622的该第一绕组的所有支撑组件624a是藉由线圈组件623而连接至该螺旋支撑带602。螺旋支撑带602的尖峰620不会与末端支撑部分622相连接。而过渡线圈部分621则是让末端支撑部分622能够具有一大体上平直的末端625。支架400的螺旋支撑带402会过渡并延伸为一末端部分,在此,形成该末端部分的波浪型样支撑组件的该第一绕组AT1的角度会大于该螺旋支撑带的角度As。第二绕组AT2的角度会大于AT1,并且,该末端部分的接续绕组的角度会增加(亦即,AT1<AT2<AT3<AT4)。
相关的定义叙述如下:
(N)--在该螺旋支撑组件的一个圆周绕组中的螺旋支撑组件数量。
(As)--螺旋支撑带绕组自支架的长轴测量起的角度。
(Ac)--线圈组件自支架的长轴测量起的有效角度。
(Pl)--支撑部件前进一个圆周绕组的纵向距离(间距),相等于支架的圆周除以As的反正切值(arctangent)。
(Ps)--在螺旋支撑带的一螺旋支撑组件的支撑支柱之间的圆周距离(间距)。在假设该螺旋支撑带的所有支撑组件的该圆周支撑间距皆相等的情形下,该圆周支撑间距会相等于支架的圆周除以N。
(NSC)--在支撑部件前进时,一螺旋组件间的该支撑带的支撑组件数量。
(CCDn)--相互连接的支撑组件间的支撑带的支撑组件数量,相等于NSC减去N。
(CCD)--圆周线圈距离是指相互连接的支撑组件间的圆周距离,其在该CCDn部分中所有的支撑组件的Ps若皆为相等,会相等于CCDn乘上Ps。
(Lc)--在表1中所叙述的几何关系三角形所定义的该螺旋组件的有效长度。
(SS)--在表1中所叙述的几何关系三角形中所定义的支撑分隔。
(Ls)--有效支撑长度,相等于P1减去SS。
(Ns)--形成该螺旋支撑带的相邻波浪型样支撑组件的数量。
线圈-支撑率(Coil-Strut ratio)--Lc对Ls的比率乘上形成该螺旋支撑带的相邻波浪型样支撑组件的数量Ns,以数字表示则相等于Lc/Ls*Ns。
支撑长度-支撑分隔率(Strut length-Strut Separation ratio)-该有效支撑长度(Ls)对该支撑分隔(SS)的比率,以数字表示则相等于Ls/SS。
在一实施例中,支撑角度As以及线圈角度Ac之间的差异会超过约20度。因为在支架进行卷曲时该线圈角度对于变浅的必需性,因此,若在扩张状态下,该线圈角度以及该支撑角度过于接近彼此时,则会使得卷曲支架时的困难度增加。
就本发明的支架而言,该支撑长度-支撑分隔率是对于该支撑角度以及该线圈角度的相对角度的一测量。而当支架具有少于约2.5的支撑长度-支撑分隔率时,其卷曲行为则是可以获得改善。若是在已扩张状态下,该支撑部件的角度是介于55度至80度之间,以及该线圈角度是介于45度至60之间时,则支架特性将可更进一步地获得改进。此外,在已扩张的状态下,较陡峭的线圈角度会使得卷曲本发明的支架变得更困难。而在已扩张状态下少于60度的线圈角度则是较有利于根据本发明的支架的卷曲。
对根据本发明的该支架而言,除了在卷曲期间改变该线圈角度以外,该螺旋支撑带亦可以绕着该支架的长轴旋转,以在卷曲期间容纳螺旋支撑带的接续绕组间的连接,进而在该支架进行卷曲时,使得该螺旋支撑带在沿着该支架长度上获得更多的绕组。对根据本发明的该支架而言,该几何关系三角形可以被用来估计在卷曲该支架期间,螺旋支撑带的预期旋转量。若是该几何关系三角形可以决定该支架的一既有直径尺寸的状态,则该几何关系三角形就能够以接下来的假设作为基础而估计任何其它尺寸的状态:对任何直径尺寸的状态而言,有效线圈长度(Lc),有效支撑长度(Ls),以及螺旋支撑带(Pl)的纵向间距都是一定值。在已知上述的假设以及于已扩张以及已卷曲状态下的几何关系三角形的情形下,若假设该螺旋支撑带的支撑组件的圆周支撑间距(Ps)对该螺旋支撑带中的所有支撑组件而言皆为相等,则该螺旋支撑带为了在卷曲期间容纳相互连接的线圈组件而在该螺旋支撑带的每一个绕组绕着该支架的轴进行旋转的量可以被估计。在考虑到当该支架进行卷曲时螺旋支撑带绕组沿着该支架的长度上的增加可有助于支架进行缩短的情形下,较具优势地是,本发明的支架在卷曲时,螺旋支撑带绕组的量会有大约少于约30%的增加,较佳地是,少于大约26%。26%的螺旋支撑带绕组增加所对应的大约是20%的缩短,而这则被视为是临床上的最大的有用缩短量;于此藉以整体视为参考倂入本案的是:Serruys,Patrick,W.,and Kutryk,Michael,J.B.,Eds.,Handbook of CoronaryStents,Second Edition,Martin DunitzLtd.,London,1998。
图6是根据本发明技术的一另一实施例的支架700的一平面图。螺旋支撑带702会自支架700的一端螺旋地前进至另一端。每一个支撑组件703是藉由线圈组件707而被连接至螺旋支撑带702的一接续绕组中的一支撑。支撑组件703包括支柱部分709。支柱部分709的每一个具有相等的长度。
图7是根据一另一实施例的支架800的平面图,图8则为其局部显示。在此实施例中,线圈组件807包括于末端853以及854处的曲线过渡部分852。曲线过渡部分852连接至支撑组件803。
支架800于每一末端861处包括过渡螺旋部分859以及末端支撑部分858。末端支撑部分858是由一对相连接的支撑绕组860所形成。线圈组件807包括由间隔808所分开的二个线圈部分807a以及807b,如图8所示。间隔808可以具有等于0的大小,而使得线圈部分807a以及807b相接触。间隔808在末端853以及854附近终止。间隔808可以在沿着线圈807长度上的任何位置、或是沿着线圈807的多个点处终止,因而使得该间隔可以沿着线圈807而具有中断。
支架400,500,600,700,以及800是由一般常见用于可自展式支架的材质所制成,例如,镍钛诺镍钛合金(Nitinol nickel-titanium alloy)(Ni/Ti),正如于已知技术中所熟知。
根据本发明的支架可以利用已知技术中所熟知的程序而被置入脉管之中。该等支架可以被装入一导管的近端之中,再向前移动通过该导管,然后于所需位置处被释放或者,二者择一地,该等支架也能够以压缩状态而由导管的远程携带,然后再于所需位置处释放。该等支架可以是自展式、或是藉由一装置(例如,该导管的一可膨胀气囊区段)而进行扩张。当该(等)支架已经被设置在所需的管内位置(intralumenal site)之后,该导管就会被移除。
根据本发明的支架可以在不伤害到腔壁的情形下而被放置在身体内腔之中,例如,包括人类在内的任何哺乳类物种的脉管、或输送管。举例而言,该支架可以被放置在一病灶、或一动脉瘤之中,以治疗该动脉瘤。在一实施例之中,该可挠支架会在被插入脉管中之后,被放置在一股浅动脉(superfemoral artery)之中。在治疗一不健全脉管、或输送管的方法中,一导管则是会被引导至不健全脉管、或输送管的一目标位置。该支架通过该导管而前进至该目标位置。举例而言,该脉管可以是一血管,股动脉(femoropoplitealartery)、胫动脉(tibial artery)、颈动脉(carotid artery)、髂动脉(iliac artery)、肾动脉(renal artery)、冠状动脉(coronary artery)、神经血管(neurovascular)动脉、或静脉。
根据本发明的支架可以良好地适应在人类身体中需要显著生物机械力的脉管治疗。被植入于人体脉管中、会经历显著生物机械力的支架,其在进行合法贩售前,则是必须要通过严格的疲劳测试。这些测试会模拟人体中相等于10年使用期间的循环数量负载。取决于所仿真的负载状况,测试循环的数量会落在1至400百万次循环的范围之内。举例而言,要在股浅动脉中使用的支架会需要通过一弯曲测试,在此测试中,支架会以半径约20mm的方式弯曲1至100百万次、或是会进行1至10百万次径向约10%的压缩。
虽然本发明当前的较佳实施例已经为了举例说明的目的而进行揭示,但本领域具通常知识者将可理解的是,在不脱离所附权利要求书所定义的本发明的范畴以及精神的情形下,许多的附加,修饰,以及取代都是有可能的。举例而言,一支架可以制造为具有仅向右转、或仅向左转螺旋的部分,或是该螺旋支撑带可以在绕组方向上有多个翻转,而非仅一个。另外,该螺旋支撑带也可以在每单位长度中、或一可变的间距中具有任意数量的旋转,并且,该等支撑带、及/或线圈带可以沿着该支架而有不相等的长度。
Claims (12)
1.一种自展式可挠支架,包括:
一螺旋支撑带,螺旋地环绕该支架的一轴而进行卷绕,其中,该螺旋支撑带包括一波浪型样的支撑组件,该波浪型样在该波浪型样的每一端上具有多个尖峰;以及
多个线圈组件,螺旋地环绕该支架的一轴而进行卷绕,其中,该等线圈组件前进的方向相同于该螺旋支撑带通过或靠近一第二绕组的该等尖峰的至少其中一些而将该螺旋支撑带的一第一绕组的该等尖峰的至少其中一些相互连接的方向,
其中,一几何关系三角形被建构为具有一第一边、一第二边、以及一第三边,该第一边的支柱长度Lc是在该螺旋支撑带的该等第一以及第二绕组的该等相互连接尖峰之间的该线圈组件的有效长度,该第二边的支柱长度是将藉由该线圈组件而相互连接的该第一绕组的尖峰以及该第二绕组的尖峰之间的圆周距离除以该螺旋支撑部件自该支架的长轴起算的一角度As的一正弦值,该第三边的支柱长度是该螺旋支撑带前进一个圆周绕组(Pl)的长轴距离减去该有效支撑长度LS,该第一边的一第一角是180度减去该角度As,该第二边的一第二角是该线圈组件自该长轴起算的一角度Ac,以及该第三边的一第三角是该角度As减去该角度Ac;以及
其中,由该第一支柱长度LC对一长度LS的一比率乘上形成该螺旋支撑带的相邻波浪型样支撑组件的数量Ns所得出的一线圈-支撑率大于、或等于约1。
2.根据权利要求1所述的支架,其中,该线圈-支撑率大于2.0。
3.根据权利要求1所述的支架,其中,该螺旋支撑带包括:
多个该波浪型样的支撑组件,其中,每一个波浪型样的支撑组件彼此连接。
4.根据权利要求3所述的支架,其更包括二个该波浪型样。
5.根据权利要求3所述的支架,其更包括三个该波浪型样。
6.根据权利要求1所述的支架,其更包括:
一支撑部分,被连接至该螺旋支撑带的一端,其中,该支撑部分环绕该支架的该轴而进行卷绕,以及包括多个支撑组件,并且,该支撑部分以垂直于该支架的该轴的一平面与该支撑部分绕组之间所形成的一锐角而环绕该支架的该轴,其中,该锐角小于垂直于该支架的该轴的平面与该螺旋支撑带的绕组之间所形成的一锐角;以及
过渡螺旋部分,其被相互连接于该支撑部分以及相邻于该支撑部分的该螺旋支撑带的一绕组之间,其中,该过渡螺旋带包括过渡螺旋组件,且该过渡螺旋组件使相邻于该支撑部分的该螺旋支撑带的该绕组的该等线圈组件的至少其中一些以及该支撑部分的该等支撑组件的至少其中一些相连接。
7.根据权利要求6所述的支架,其中,当该支撑部分的该绕组朝着远离该螺旋支撑带的方向前进时,相邻的该等过渡螺旋组件在该支架圆周附近的一较短的长度内向前延伸。
8.根据权利要求6所述的支架,其中,该螺旋支撑带的该等线圈组件的其中一些不会与该支撑部分相连接。
9.根据权利要求1所述的支架,其中,在该对支柱部分中的该等支柱部分的每一个具有相等的长度。
10.根据权利要求1所述的支架,其中,该等线圈组件在其每一端包括一弯曲的过渡,且该弯曲的过渡部分会连接至该螺旋支撑部件的该等尖峰。
11.根据权利要求1所述的支架,其中,该等线圈组件包括由一间隔所分开的一对线圈部分。
12.一种自展式可挠支架,包括:
一螺旋支撑带,螺旋地环绕该支架的一轴而进行卷绕,其中,该螺旋支撑带包括一波浪型样的支撑组件,该波浪型样在该波浪型样的每一端上具有多个尖峰;以及
多个线圈组件,螺旋地环绕该支架的一轴而进行卷绕,其中,该等线圈组件前进的方向相同于该螺旋支撑带通过或靠近一第二绕组的该等尖峰的至少其中一些而将该螺旋支撑带的一第一绕组的该等尖峰的至少其中一些相互连接的方向,
其中,一几何关系三角形被建构为具有一第一边、一第二边、以及一第三边,该第一边的支柱长度Lc是在该螺旋支撑带的该等第一以及第二绕组的该等相互连接尖峰之间的该线圈组件的有效长度,该第二边的支柱长度是将藉由该线圈组件而相互连接的该第一绕组的尖峰以及该第二绕组的尖峰之间的圆周距离除以该螺旋支撑部件自该支架的长轴起算的一角度As的一正弦值,该第三边的支柱长度是该螺旋支撑带前进一个圆周绕组(Pl)的长轴距离减去该有效支撑长度LS,该第一边的一第一角是180度减去该角度As,该第二边的一第二角是该线圈组件自该长轴起算的一角度Ac,以及该第三边的一第三角是该角度As减去该角度Ac。
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- 2008-08-01 EP EP08794985A patent/EP2175802A4/en not_active Ceased
- 2008-08-01 CN CN200880109327.5A patent/CN101868195A/zh active Pending
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Publication number | Publication date |
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EP2175802A1 (en) | 2010-04-21 |
US7988723B2 (en) | 2011-08-02 |
US20110245910A1 (en) | 2011-10-06 |
US8500794B2 (en) | 2013-08-06 |
AU2008282733B2 (en) | 2014-04-10 |
CA2698294A1 (en) | 2009-02-05 |
US20090036976A1 (en) | 2009-02-05 |
AU2008282733C1 (en) | 2014-09-04 |
WO2009017827A1 (en) | 2009-02-05 |
JP5649965B2 (ja) | 2015-01-07 |
JP2010535075A (ja) | 2010-11-18 |
AU2008282733A1 (en) | 2009-02-05 |
EP2175802A4 (en) | 2012-08-08 |
MX2010001309A (es) | 2010-06-17 |
CA2698294C (en) | 2016-09-06 |
NZ583237A (en) | 2012-11-30 |
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