CN1787793A - 具有支柱间相互连接单元的腔内支架 - Google Patents
具有支柱间相互连接单元的腔内支架 Download PDFInfo
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- CN1787793A CN1787793A CNA2004800129661A CN200480012966A CN1787793A CN 1787793 A CN1787793 A CN 1787793A CN A2004800129661 A CNA2004800129661 A CN A2004800129661A CN 200480012966 A CN200480012966 A CN 200480012966A CN 1787793 A CN1787793 A CN 1787793A
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- interconnecting members
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- intracavity stent
- stent
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Abstract
一种腔内支架(10),由多个周向扩张单元(12)排列组成所述腔内支架(10)的周向部分并沿支架(10)的纵轴线延伸,和多个相互连接毗邻诸对周向扩张单元(12)的相互连接单元(14)组成的腔内支架(10),所述相互连接单元(14)连接毗邻诸对周向扩张单元的支柱(16),连接处位于支柱(16)的大致中点处。
Description
技术领域
本发明总体涉及设计为通过使用最小侵害性方法(minimally invasivetechniques)例如使用穿越导丝的传送导管经皮的血管内置入解剖通道的腔内支架、涂层支架和各种支架植入物。更具体地,本发明涉及具有骨架(scaffold)结构和某些结构性几何排列的腔内支架,该几何排列特别适于提供生理学上可接受的径向或环状强度和纵向挠性,同时本发明装置的内腔表面在流体通过该表面时呈现较小的纵向剪切力的阻力,该表面还有最大限度的疲劳寿命和抗腐蚀性。另外,本发明腔内支架的特征是其几何排列结构在径向扩张时特别的表现为负的纵向缩短系数。因此,本发明的腔内支架的独特方面是它在径向扩张时能够延伸。
发明背景
腔内支架通常为由可植入的生物相容性材料制成的管状骨架。通常支架具有管状的几何排列,其特征为中心腔、纵向轴线、周向轴线和径向轴线。传统腔内支架一般分为3类:球囊扩张、自扩张和形状记忆型。球囊扩张支架需要机械性干预,例如使用球导管从支架的中心腔施加径向向外的正压,以使支架机械变形和使支架直径增大。自扩张支架利用支架材料的固有机械特性扩张支架,自扩张支架一般由当在其上施加正压时可回弹的材料制成。自扩张支架被制成在第二增大的直径时为零应力的结构。自扩张支架被压缩成第一较小直径并被约束在输送导管内用于腔内传送。去除约束使约束压力释放,自扩张支架在自身机械特性的作用下回弹至第二增大直径。最后,形状记忆型支架依赖于独特的合金,该合金在某种热状态下显示形状记忆特性。传统形状记忆支架典型地是通常被称为镍钛诺的镍钛合金,其在正常体温、即37摄氏度或接近正常体温时发生相位转变。
现有技术已涵盖了所有支架分类的各种支架设计。很多传统支架设计的困难之处源于支架所需的下述特性之间标准的相互冲突,支架的圆周或环状强度、纵向或柱状强度、纵向挠性、支架各结构单元的起鳞(fish-scaling)、疲劳寿命、抗腐蚀性、腐蚀疲劳、血流动力学、辐射不透过性和生物相容性以及支架穿过已植入支架的能力。一个典型的例子为使环状强度最佳化的支架设计建立在损失柱状强度和/或纵向挠性的基础上,而为使柱状强度最佳化的支架设计常折衷了其纵向挠性和/或环状强度。
多数传统支架在径向扩张时呈现纵向的缩短。纵向缩短是支架众所周知的特性,它源自支架的结构单元由收缩状态径向扩张至直径上扩张状态时的几何变形。已发明的一些现有技术的支架声称这些支架的新特性是不发生显著的缩短。但是至今为止,本领域尚无从收缩状态径向扩张至直径上扩张状态时能纵向伸长的支架。
理想的腔内支架发明设计是应用一系列第一和相互连接单元,这些连接单元的几何形状排列能平衡腔内支架在环状强度、柱状强度和纵向挠性之间的要求。许多传统支架应用一系列各种形状的圆周结构单元和纵向结构单元。很大部分的传统支架使用制成弯曲形状或Z字形的圆周结构单元,使用这种形状是因为支架径向扩张的需要。这些应用弯曲形状或Z字形圆周结构单元的传统支架中,很多也使用连接毗邻圆周结构单元的纵向结构单元,并在保持该装置的纵向挠性的同时提供少量纵向或柱状强度。另外,许多传统支架需要焊接以连接支架的各种结构的连接表面。
然而,迄今为止,本领域尚未设计出能够在以下特性之间取得平衡的一体式支架结构单元几何的排列,这些特性包括环状强度、柱状强度和纵向挠性、纵向缩短程度、支架的圆周强度或柱状强度、纵向强度或柱状强度、纵向挠性、支架各结构单元的起鳞、疲劳寿命、抗腐蚀性、腐蚀疲劳、血流动力学、辐射不透过性和生物相容性以及支架穿过已植入支架的能力。术语“起鳞”在本领域和本文中用于描述在径向扩张、植入的过程中或支架通过脉管系统内的弯曲时某些支架结构单元延伸超出支架的圆周平面的状况。本领域普通技术人员知道支架结构单元的起磷可能导致支架在腔内输送期间或植入后撞击或绊住组织。本文中使用的术语“一体式”意为不需焊接、用一整块材制成的支架。
本发明的腔内支架可能是,但并不一定是通过汽相淀积技术制成。本发明的支架的汽相淀积制造具有很多优点,包含但不局限于:制造复杂几何排列的支架的能力、控制疲劳寿命、抗腐蚀性、腐蚀疲劳、主体和表面材料的特性的能力、以及影响支架的纵轴挠性、环状强度和径向扩张外形的方式改变支架结构单元的横向放置时的外形、Z轴厚度和X-Y轴表面积的能力。
发明内容
腔内支架、涂层支架和各种支架植入物设计本身试图优化径向扩张的各功能特性,所述功能特性像输送直径与扩张直径的比值、环状强度、纵向挠性、纵向缩短特性、柱状强度、支架各结构单元的起鳞、疲劳寿命、抗腐蚀性、腐蚀疲劳、血流动力学、生物相容性以及支架穿支架输送的能力。传统支架设计必须折衷支架的一个或多个功能特性,以使某特殊功能最大化,例如纵向挠性被最小化以获得理想的柱状强度,或者以小的径向扩张比的代价获得高的环状强度。本发明的一目的是提供腔内一体式支架的设计,所述支架设计能获得以下特性之间的平衡:径向扩张比值、环状强度、纵向挠性和柱状强度、生物相容性、血流动力学,辐射不透过性、起鳞最小或无起鳞及增加内皮愈合能力。
依据本发明的一个较佳实施例,本发明的腔内支架由一片生物相容性金属或拟金属(psedometal)制成,具有多个沿支架的纵向轴线共轴排列的周向扩张单元和多个相互连接毗邻诸对周向扩张单元的多个相互连接单元。多个周向扩张单元中的每一个包含通过支架的支柱单元相互连接的连续的峰和谷的大体上正弦曲线形环状结构。相互连接单元的每一个大约在毗邻各对周向扩张单元上的支架支柱单元的中点相互连接毗邻各对周向扩张单元。为了增强本发明支架的纵向挠性,发现理想的设计是在每一相互连接单元上包括一段较小的末端区域,该末端区域在宽度上窄于相互连接单元主要的中间区域。较小的末端区域位于每一相互连接单元的近端和远端,其宽度较窄,以增强支架支柱单元和相互连接单元之间的连接区域的弯曲性。另外,发现理想的相互连接单元的末端区域的形状大体上呈C字形,从每一相互连接单元中间区域向近侧或远侧延伸。
依据本发明所有的实施例,多个周向扩张单元和多个相互连接单元中的每一个可由相似的生物相容性材料、更好的是用生物相容性金属或金属合金制成。这样,多个周向扩张单元和多个相互连接单元具有相似的物理材料特性,例如拉伸强度、挠性模量、塑性变形能力、挠性偏移、形状记忆或超挠性特性。或者,多个周向扩张单元和相互连接单元可由不同物理或材料特性的生物相容性材料、更好的是用生物相容性金属或金属合金制成。以后一种方式,多个周向扩张单元可以例如由可塑性变形材料制成,例如不锈钢,而多个相互连接单元由形状记忆或超挠性材料例如镍钛合金,或由挠性偏移(spring biased)材料例如不锈钢制成。
迄今为止,腔内支架的诸单个部分之间的连接需用焊接来实现。本发明的一个特殊优点是通过使用汽相淀积技术形成该支架,不仅各单个部分在原子水平上连接起来而不需焊接,而且支架的不同的和各个部分可使用不同的材料以形成各单个部分独特的材料特性而具备独特的功能。
最后,本发明还包含自支持腔内植入物,此处使用的术语“植入物”意为指示具有整体柱状和圆周状强度并具有穿越其厚度的开口的任何类型管状单元。本发明的自支持腔内植入物较佳地包含由多层中的至少一层形成的单元,每层包含多个如上述彼此交叉的第一和相互连接单元,以形成交叉的各对第一和相互连接单元之间的多个开口区域。一薄条区对着开口区域的至少一部分,至少局部地闭合多个开口区的各开口区域。多个层中连续的毗邻各层被布置成使开口区域在横穿过自支持腔内植入物的壁的Z轴线上交错,通过开口区域的交错产生层间的空间以方便该腔内植入物的内皮愈合。
附图简述
图1是依据本发明的腔内支架处于其扩张的直径时的立体图。
图2是本发明的腔内支架第一实施例的平面图。
图3是本发明的腔内支架第二实施例的平面图。
图4是本发明的腔内支架第三实施例的平面图。
图5是本发明的腔内支架第四实施例的平面图。
图6是本发明腔内支架的一相互连接单元和部分诸周向扩张单元的显微照相。
图7是显微照相,示出了本发明的腔内支架处于其压缩的直径状态,用于在约束护套内进行腔内输送。
图8是显微照相,示出了本发明的腔内支架从约束护套中部分释放并径向扩张。
图9是显微照相,示出了本发明的腔内支架处于其径向增大的直径状态。
具体实施方式
依据本发明提供了一些较佳的实施例。在本发明的每一较佳实施例中,本发明的腔内支架的总体结构基本相同。特别地,具体参考图1,本发明的腔内支架10一般包含一管状圆柱形单元,该管状圆柱形单元包含多个通常围绕支架10的圆周轴线C’形成多个闭合环并相对于彼此沿支架10的纵轴线L’共轴间隔开排列的周向扩张单元12。多个相互连接单元14相互连接毗邻的诸对多个周向扩张单元12。多个周向扩张单元12中的每一个都具有多个峰12p和多个谷12t的大体上正弦曲线结构,多个支柱16相互连接毗邻峰12p和谷12t。位于一个圆周环单元12内的多个峰12p和谷12t可以与毗邻圆周环单元12内的多个峰12p和谷12t同相或异相。另外,在每一圆周环单元12内,峰12p和谷12t可以具有规则或不规则的周期,或者多个周向扩张单元的每一个可具有规则周期的区域和不规则周期的区域。多个相互连接单元14中的每一个较佳地包含通常具有宽度Wi的各直线形单元,相互连接第一周向扩张单元12的支柱16和第二毗邻的周向扩张单元12的支柱16。多个相互连接单元的每一个具有通常矩形横截面形状。依据本发明每一较佳的实施例,多个相互连接单元14中的每一个与支柱16间的相互连接大约位于支柱16整个长度的中点。多个支柱16的每一个具有宽度Ws并且通常为矩形横截面。
另外,可具有多个以虚线示出的末端凸缘单元11以提供用于将移植套(未示出)固定在支架10上的固定点。末端凸缘单元11可放置在支架10的远端、近端或两端,较佳地为在支架10的近端或远端或两端从末端周向扩张单元12的峰12p或谷12t形成通常直线形的凸起。多个凸缘单元11中的每一个还可包含圆形远端或近端区域以便于移植套的固定。
参考图2和6,为了便于将本发明的支架10收缩为第一个较小的输送直径,发现较佳地在每一峰12p和谷12t处设有通常U-形的铰链单元22,该铰链单元沿每一周向扩张单元12连接毗邻的支柱。依据本发明较佳的实施例,理想的是每一通常U-形的单元铰链的宽度为Wh,Wh小于其连接的支柱16的宽度Ws。通过使Wh小于Ws,发现被通常U-形的铰链单元22相互连接的毗邻支柱16之间形成的角α可被更大程度压缩,因而本发明的支架10较不使用U-形铰链单元22的场合能被更大程度压缩。
另外,发现理想的是,依据本发明最佳方式,在多个相互连接单元14中每一个的相对末端具有应变释放段18和20。应变释放段18和20包含相互连接单元14的末端部分,其宽度为Wt,Wt小于相互连接单元14的宽度Wi。依据本发明的一个实施例,应变释放段18和20每一个都具有通常C-形结构,并在连接相互连接单元14和毗邻周向扩张单元12的支柱16中跨越一半径。也可考虑以其它几何结构代替C-形末端应变释放段18和20,例如S-形、V-形、M-形、W-形、U-形或沿每一相互连接单元14的纵向轴线共轴凸起的仅为I-形的延伸部分。
图2-5描述了本发明的支架10的其它较佳实施例。图2-5中每一示出的每一较佳实施例包含相同的周向扩张单元12,每一个该单元都具有多个峰12p和谷12t并形成多个在峰12p和谷12t处相互连接的支柱16、形成峰12p和谷12t的通常U-形的单元22,和毗邻各对周向扩张单元12被多个相互连接单元14互相连接。这样,在各图2-5中,用相同标号表示相同部分。本发明的其它较佳实施例30、40、50、60分别在图2、3、4、5中描述,主要区别是多个相互连接单元14的位置和方向不同。图2-5中,支架30、40、50、60每一个均以平面图描述。本领域技术人员应明确平面图是为了方便描述,所描述的支架为管状,线A-A和B-B形成沿支架纵向轴线L’的分割线以采用平面图形式描述支架的几何排列。
图2中,支架30包含多个周向扩张单元12和多个相互连接单元14。多个相互连接单元14中的每一个连接毗邻诸对周向扩张单元14。每一相互连接单元14形成与每一毗邻周向扩张单元12的支柱16的连接,与支柱16大约在沿每一支柱16的长度的中点相交。多个相互连接单元14沿支架30的纵向轴线L’形成诸分组14a、14b、14c、14d、14e和14f。由于相互连接单元14位于峰12p和谷12t与支柱16的围绕角α可折叠的平面内,发现理想的是相互连接单元14每一个都从平行于支架30的纵轴线L’的一直线偏移一个角度β以加强周向扩张单元12在支架30从较大直径压缩为较小直径时的可折叠性。在支架30中,在诸分组14a-14f中多个相互连接单元14中的每一个具有相同的偏移角度β以及所有相互连接单元14彼此平行。为了容纳偏移角β,并在支架从较大直径向较小直径压缩时使相互连接单元14折叠,位于每一相互连接单元14末端的应变释放段18和20方向相反。因此,当从支架30的管状结构和从近端视点P看该支架时,第一应变释放段18具有通常向右旋或顺时针方向的通常C-形结构,而第二应变释放段20具有通常向左旋或逆时针方向的通常也是C-形的结构。
依据支架30的较佳实施例,发现理想的是峰12p或谷12t与相互连接单元采用2∶1的比例。这样,如所描述的,在多个周向扩张单元12的每一个中,都有6个峰12p和6个谷12t以及3个相互连接单元14连接每一对毗邻的周向扩张单元12。类似地,在毗邻各对周向扩张单元12之间,相互连接单元14与毗邻一对周向扩张单元12的相互连接单元14沿圆周偏离一个峰12p和一个谷12t。因此,组14a、14c和14e中的相互连接单元互连各对周向扩张单元12a-12b、12c-12d、12e-12f、12g-12h和12i-12j,组14b、14d和14f中的相互连接单元互连各对周向扩张单元12b-12c、12d-12f、12f-12g、12g-12h。组14a、14c和14e中的相互连接单元每一个都沿每一周向扩张单元12的圆周轴偏离一个峰12p和一个谷12t。
如图3所示,支架40具有几乎相同的周向扩张单元12和相互连接单元14结构,但支架40不采用峰12p或谷12t与相互连接单元的2∶1比例,而是采用3∶1的比例,这样周向扩张单元12a-12i每一个都有6个峰12p和6个谷12t,但毗邻各对周向扩张单元仅由两个相互连接单元14连接。象支架30一样,第一周向扩张单元对的相互连接单元与第二相邻的周向扩张单元对的相互连接单元沿圆周偏离,但支架40中偏离一个峰12p和二个谷12t或二个峰12p和一个谷12t。支架40中有四组相互连接单元14a、14b、14c和14d相互连接多个周向扩张单元12。相互连接单元组14a和14c互相连接各对周向扩张单元12b-12c、12d-12e、12f-12g、12h-12i,相互连接单元组14b和14d互相连接各对周向扩张单元12a-12b、12c-12d、12e-12f、12g-12h。
支架40中,每一相互连接单元14也从支架的纵向轴线以一角度β成角度偏移,但多个相互连接单元14并不都彼此平行。而是,相互连接单元组14a和14c中的相互连接单元彼此平行以及相互连接单元组14b和14d中的相互连接单元彼此平行,而相互连接单元组14a和14c中的相互连接单元从支架的纵向轴线偏移一个角度β-,以区分表示为角β+的β,形成与组14b和14d中相互连接单元相对于纵轴线L’的偏离。标识角度β+和β-是为了表示这些角度代表从纵轴L’偏离几乎相同的角度,但相对于支架40的圆周轴线有不同的方向。
现参考图4,图4中描述了支架50。如上述支架30和40一样,支架50具有相同的周向扩张单元12,具有相互连接多个支柱16的多个峰12p和谷12t,和U-形段22,以及相互连接单元14。然而,支架50中多个相互连接单元14形成两组相互连接单元14a和14b。相互连接单元14a和14b中的每一单独的相互连接单元14也从支架50的纵向轴线L’以一角β成角度偏移。而且,在每一对周向扩张单元12内,相互连接单元组14a和14b沿圆周彼此偏离三个峰12p和三个谷12t。然而,在每一组相互连接单元14a和14b中,多个单独的相互连接单元中的每一个基本上沿共同的纵向轴线排列。以这种方式,除了最近侧的12a和最远侧的12i圆周环单元外,多个相互连接单元中的每一个大约在支柱16的中点在每一周向扩张单元12b-12h上形成一实质上的四点连接19。该实质上的四点连接19在一个相互连接单元的远侧应变释放段20和一支柱16的近侧以及毗邻的相互连接单元14的近侧应变释放段18和同一支柱16的远侧之间形成。
最后,如图5所示,示出了支架60。象支架30、40、50一样,支架60包含多个周向扩张单元12和相互连接毗邻各对周向扩张单元12的相互连接单元14。如图3中的支架40一样,支架60的相互连接单元14有多组:14a、14b、14c和14d。然而在支架60内,相互连接单元组14a和14d相互连接诸相同对周向扩张单元12,相互连接单元组14b和14c相互连接诸相同对周向扩张单元12。相互连接单元组14a和14d中的每一个相互连接单元从支架60的纵轴L’以一角度β-成角偏移并且彼此平行。类似的,相互连接单元组14b和14c中的每一个相互连接单元从支架60的纵轴线L’以一角度β+成角偏移且彼此平行。
对于每一对毗邻的周向扩张单元12而言,相互连接单元14从支架60的纵向轴线L’偏移不同的方向。例如,对于周向扩张单元对12a-12b而言,14b组和14c组的相互连接单元分别偏移角度β+和β-。在相邻的周向扩张单元对12b-12c中,组14a和14d的互连单元分别编移β-和β+。因此,毗邻各对周向扩张单元12之间,相互连接单元是异相的,这是因为它们具有不同的角度β的倾斜方向。另外,在毗邻各对周向扩张单元12之间,相互连接单元沿圆周偏离一个峰12p,相互连接单元组14a与相互连接单元组14b沿圆周偏离一个峰12p,相互连接单元组14c与相互连接单元组14d沿圆周偏离一个峰12p。并且,在单独的各对毗邻周向扩张单元12内,各对相互连接单元14b-14c与14a-14d之间沿圆周的偏离不同。相互连接单元组14b-14c之间沿圆周的偏离为2个峰12p和3个谷12t,而相互连接单元组14a-14d之间沿圆周的偏离为4个峰12p和3个谷12t。
本领域技术人员会理解前述描述了不同几何排列的实施例支架10、20、30、40和50都包含共同的结构单元,即具有多个峰12p和多个谷12t的各周向扩张单元12和由铰链单元22相互连接的各支柱16。再者,本领域技术人员会理解本发明也考虑了毗邻各对周向扩张单元12之间的沿着支架的圆周轴线的相互连接单元的数目和位置的改变,参照附图示出和描述的特定实施例在性质上是示例性的。
然而图3代表了本发明的支架40的特别较佳的实施例。发明的支架40以镍钛亚管制成,由激光切割出所描述的几何排列。激光切割后,支架40被退火以设置支架40的形状记忆特性,该支架带有完全扩张时增大的5.8mm的外径和30.6mm的长度。支架40能被收缩至另一较小的收缩外径1.4mm,并被如图7所示被放置在一约束护套内。由于支柱16在通常U-形的铰链单元22处通过角度α折叠而在周向扩张单元12和相互连接单元14之间没有明显阻碍,因而支架40表现出优越的收缩性。
在支架40从其压缩的第一较小直径即1.4mm径向扩张至其第二增大的直径即5.8mm的过程中,支架40不展现很多本领域已知的许多支架几何排列所展现的缩短特性。与缩短相反,支架40意外地延伸了2.5%。迄今为止,本领域尚无径向扩张时延伸的支架。
图8示出当约束护套从支架40撤除时支架40径向扩张的情况。图9描绘了支架40最终处于其径向完全扩张时的直径的状态,仅仅该支架40的近侧部分被约束在约束导管内(未示出)。图6是支架40的一个放大的部分,示出周向扩张单元12和相互连接单元14之间、远侧和近侧应变释放段18和20处的支柱-中部连接,清楚显示了每一周向扩张单元12的大体上U-形铰链单元22、峰12p和谷12t。图6还清楚示出了近侧和远侧应变释放段的宽度Wt与相互连接单元14的主体的宽度Wi之间的不同,以及U-形铰链单元22的宽度Wh与支柱16的宽度Ws之间的不同。
多个周向扩张单元12和相互连接单元14、以及它们的各组份部分较佳地由从钛、钒、铝、镍、钽、锆、铬、银、金、硅、镁、铌、钪、铂、钴、钯、锰、钼以及它们的合金、镍钛诺和不锈钢组成的组中选出的材料制成。多个周向扩张单元12和多个相互连接单元14可由相同或不同的材料制成和有相同或不同的材料特性。术语“材料特性”意在包含物理特性,物理特性包含但不限于挠性、拉伸强度、机械特性、硬度、主体和/或表面晶粒尺寸、晶粒组成和晶粒边界尺寸、晶粒内和晶粒间沉淀物。类似地,为多个周向扩张单元12和多个相互连接单元14选择的材料可被选择为具有相同或不同化学特性。术语“化学特性”意在包含任何化学反应和材料在植入身体后可能发生的状态的改变以及植入后身体对材料的生理反应。
虽然本发明的支架可通过本领域公知的化学、热或机械消蚀方法例如化学蚀刻、激光切割、EDM或喷水加工制成,还预见到的制造本发明支架的较佳方法为通过物理汽相淀积技术。物理汽相淀积技术能够严格控制支架几何排列的公差以及支架和支架材料的物理和化学特性。本发明的支架10、30、40、50和60,包含其各单元即周向扩张单元12和相互连接单元14以及它们的组份部分中的每一个,较佳地由整体的、其腔内表面上具有受控的异质性的材料制成。如在作为2002年4月30日授权的美国专利第6,379,383号的分案、于2000年12月22日提交的待审查、普通转让的美国专利申请第09/754,304号中所描述的,该申请结合在此供参考,通过将支架的整体材料制成具有确定的晶粒尺寸、化学以及晶粒内和晶粒间沉淀物来控制异质性,并且在整体和表面形态不同处产生沿支架表面的诸区域或诸部位,同时保持可接受的或理想的蛋白结合能力。本发明支架特征性的理想特性是:(a)符合或超越常规认可标准的理想机械性能;(b)诸如裂缝或针孔缺陷的缺陷最少;(c)经模拟加速试验测得的400MM循环的疲劳寿命;(d)抗腐蚀和/或耐腐蚀疲劳。(e)生物相容性,材料中不含明显的生物杂质;(f)几乎无摩擦的外表面以方便无创伤地穿越和通过血管以及与用于引入支架的穿导管技术相适应;(g)在选择的部位具有放射不透过性以及与MRI兼容性;(h)具有最佳的表面能量和微貌的腔内表面;(i)与获得的期望材料特性相协调的最小的制造和材料成本;(j)成品率高。
依据本发明,通过使用与微电子和微制造真空涂层技术中应用和标准化的材料沉积方法相同的、在此结合供参考的材料沉积方法制造支架可获得前述特性。较佳的沉积方法包含离子束辅助蒸发沉积和喷射技术。离子束辅助蒸发沉积较佳采用使用惰性气体对基层同时离子撞击的双重、同步热电子束蒸发,所述惰性气体例如氩、氙、氮或氖。以惰性气体例如氩离子撞击可通过在沉积过程中增加所沉积材料的原子填充密度而减少空隙量。沉积材料中空隙量的减少使该沉积材料的材料性质类似于整体材料的性质。利用离子束辅助蒸发沉积技术可获得直至20纳米/秒的沉积速率。
采用喷射技术时,可在约4小时的沉积时间内沉积出200微米厚的不锈钢膜。喷射技术较佳地采用圆柱状喷射目标,和共中心环绕基质的单一圆周形喷射源,该基质被共轴固定在喷射源内。其他可用于形成依据本发明的支架的沉积方法有阴极电弧、激光消蚀和直接离子束沉积。当采用真空沉积方法时,沉积膜的晶体结构影响沉积膜的机械性质。沉积膜的这些机械性质可通过例如退火、高压处理或气体淬火等加工后处理进行修饰。
用于制造本发明支架的材料根据其生物相容性、机械性质如拉伸强度、屈服强度以及沉积易度进行选择,包含以下:元素钛、钒、铝、镍、钽、锆、铬、银、金、硅、镁、铌、钪、铂、钴、钯、锰、钼及它们的合金,例如锆-钛-钽合金、镍钛诺和不锈钢。
沉积过程中,腔压力、沉积压力和处理气体的局部压力是被控制的,以使期望的物质在基质上的沉积得到优化。如微电子制造、微制造和真空涂层技术领域公知的,反应性和非反应性气体是被控制的以及进入沉积腔的惰性或非反应性气体物质典型地是氩和氮。基质可以是固定的或活动的,或围绕自身纵向轴线旋转或在反应器内在X-Y平面内活动,以方便沉积材料在基质上的沉积或形成图案。沉积材料可在基质上沉积为均一固体膜,也可通过以下方式形成图案:(a)通过例如蚀刻或照相平版印刷技术在基质上形成正的或负的图案,所述蚀刻或照相平版印刷技术被应用于基质表面以产生期望图案的正的或负的图像。(b)使用一个或一套固定的或相对于基质活动的模罩来确定应用于基质的图案。图案的制作可用于在图案的空间方位和沉积膜不同区域的材料厚度两方面获得成品支架的复杂的成品几何排列,例如通过在它的长度上改变材料的壁厚,用于加厚支架近端和远端以防止支架末端在径向扩张时成喇叭形张开。
通过各种方法中的任何方法形成支架后,该支架可从基质取下。例如,可通过化学方法例如蚀刻或溶解、通过消融、机械加工或超声能量去除基质。或者,可在基质和支架之间沉积一种材料例如碳或铝作为替身层(sacrifice layer),替身层可通过熔化、化学方法、消融、机械加工或其它合适的方法去除以使支架与基质分离。
然后成品支架可接受沉积后处理以改良晶体结构,例如通过退火,或改良表面特征,例如通过蚀刻影响和控制支架血流表面的异质性。
可在支架10的腔内和/或腔外表面上形成多个微谷,如在与本申请一起普通转让的国际公告第WO 99/23977号中更完整描述的,结合该专利在此供参考。多个微谷可作为沉积后处理步骤形成,例如通过蚀刻,或在沉积过程中形成,例如通过将支架形成材料沉积在芯棒上,该芯棒表面具有导致金属作为沉积材料的一部分以微谷图案沉积的微貌。
本发明的每一个较佳实施例较佳通过采用汽相淀积技术制造,该汽相淀积技术使支架形成材料汽相沉积在基质上。基质可以是平面的或圆柱状的,可预先制成带有第一和相互连接单元的较佳几何排列之一的图案,具有正的或负的图像,或者基质可以是无图案的。基质无图案时,沉积的支架形成材料会进行沉积后图案制作,以将沉积的支架形成材料制成第一和相互连接单元的诸较佳几何排列之一的图案。对于通过汽相淀积技术制造的所有本发明的实施例,不需或仅需最小程度对已制成图案的腔内支架进行沉积后处理,即通过机械的、电的、热的或化学的加工或抛光方法修饰支架的表面。
本发明腔内支架的汽相淀积技术制造具有很多优点,包含例如制造复杂几何排列的支架的能力、埃级别的极小尺寸公差、控制疲劳寿命、抗腐蚀性、腐蚀疲劳、晶粒内和晶粒间沉淀物以及它们对抗腐蚀性和腐蚀疲劳的影响、整体材料组成、主体和表面材料的特性、辐射不透过性的能力、以及以影响支架的纵向挠性、环状强度、径向扩张性能和外形的方式改变支架结构单元的横向放置的外形、Z-轴厚度和X-Y轴表面面积的能力。整体材料组成可被调整为应用合金组成中的元素比例,这种合金组成中的元素比例调整在使用传统形成材料时是不可行的。这种调整使以优化合金组成的方式获得具有理想的材料或机械性质的特制合金组成成为可能。例如,应用超过51.5原子百分比的镍可制造展示形状记忆和/或超挠性特性的镍-钛管,由于该材料表现高稳状态应力(plateau stress),这在使用传统工艺时是不能完成的。特别地,采用本发明的方法,本发明制造了镍含量在51.5和55原子百分比之间的镍-钛合金管。
依据本发明一个较佳实施例,本发明腔内支架的汽相淀积显著减少或实质上消除了整体材料内的晶粒内部和晶粒间沉淀物。在镍-钛腔内装置制造中,通过沉淀状态改变局部晶粒镍-钛比来控制转化温度和最终的机械性质是常见的。在本发明中不需为机械特性而控制沉淀。当镍-钛在本发明中用作支架材料时,局部镍-钛比与整体材料中的镍-钛比是相同的或实质上相同的,但仍可产生最佳形态而无需沉淀热处理。与传统锻造的镍-钛合金相比,成品的沉积支架形成材料展现出优越的抗腐蚀性和因此呈现出的抗腐蚀疲劳特性。
在汽相淀积过程中,多个周向扩张单元12和多个相互连接单元14可从结构上做成通常的矩形、卵形或椭圆形横截面形状,所述横截面形状在支架的纵向轴线上带有直角边缘或倾斜边缘或弯曲的腔内和腔外前导的及尾随的表面边缘,以提供更好的血液流动的表面形状。
虽然参考其较佳实施例描述了本发明,本领域技术人员应理解和体会到前述实施例在汽相淀积和支架制造技术领域可能有多种变化形式,以及上述实施例仅为描述性的,并不限制本发明的范围,本发明的范围仅由所附权利要求限制。
Claims (9)
1.一种腔内支架,包含:
a.多个共轴线隔开的周向扩张单元,所述的周向扩张单元形成大体上管状的结构,且每一个所述单元具有由诸支柱相互连接的峰和谷的大体上波浪形图案;和
b.多个大体上直线形的相互连接单元,所述的相互连接单元与毗邻的诸对周向扩张单元相互连接,且连接于毗邻支柱沿腔内支架纵轴线的大约中点处。
2.如权利要求1所述的腔内支架,其特征在于,所述多个周向扩张单元中的每一个单元,在沿腔内支架的周向轴线上还包含大体上Z字形结构,其中所述支柱形成大体直线形的节段,并在峰和谷处通过铰链单元相互连接,所述铰链单元的宽度窄于支柱的宽度。
3.如权利要求2所述的腔内支架,其特征在于,所述多个大体上直线形的相互连接单元还包含大体上曲线形的第一和第二末端节段,所述末端节段位于每一与支柱连接的相互连接单元的相对末端。
4.如权利要求3所述的腔内支架,其特征在于,多个周向扩张单元中的每一个与多个相互连接单元中的每一个是一体的和单一的。
5.如权利要求4所述的腔内支架,其特征在于,所述的多个大体上直线形的相互连接单元的大体上曲线的第一和第二末端段还包含大体上呈C-形的节段。
6.如权利要求5所述的腔内支架,其特征在于,所述的大体上呈C-形的节段具有窄于相互连接单元的剩余部分宽度的宽度。
7.如权利要求1所述的腔内支架,其特征在于,所述的多个大体上直线形的相互连接单元都是彼此平行的。
8.如权利要求1所述的腔内支架,其特征在于,所述的多个大体上直线形的相互连接单元沿所述腔内支架的纵轴线排列为至少两组相互连接单元,所述的至少两组相互连接单元中的第一组与至少两组中的第二组相对于腔内支架的纵轴线具有不同的倾斜方向。
9.如权利要求1所述的腔内支架,其特征在于,所述的腔内支架当从较小直径扩张至较大直径时沿腔内支架的纵轴线伸长。
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CA2519226C (en) | 2013-01-15 |
CN100558320C (zh) | 2009-11-11 |
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EP2289464A1 (en) | 2011-03-02 |
WO2004084764A2 (en) | 2004-10-07 |
CA2519226A1 (en) | 2004-10-07 |
US20040186554A1 (en) | 2004-09-23 |
WO2004084764A3 (en) | 2005-05-19 |
AU2004224415B2 (en) | 2011-07-14 |
US7122049B2 (en) | 2006-10-17 |
JP2006520648A (ja) | 2006-09-14 |
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