CN1652733A - 形状记忆聚合物支架 - Google Patents
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Abstract
一种形状记忆聚合物支架或血管内流调节器,它们由具有形状记忆特性的聚合物制造,以使其可以自展开。该支架可以形成为有桁架似构造的挤压管,并由具有形状记忆特性的聚合物形成,或者可以由具有记忆特性的聚合物挤压带编织成管形形成。为部署在脉管系统中,本发明的支架可以被收缩装在推送器导管的装配部分上。然后,被装在推送器导管上的支架可以被插进脉管系统内并受控进入期望位置,并且热量能从推送器导管传输到支架,以使支架径向地展开并且轴向回缩,以把支架部署在脉管系统中,并且推送器导管从脉管系统中被收回。
Description
发明背景
技术领域
本发明一般关于用于介入疗法治疗(interventional therapeutictreatment)或者脉管手术(vascular surgery)的可植入装置,更具体地,本发明关于形状记忆聚合物支架(stent)。
技术背景
为了减少对治疗部位周围组织的损伤,介入治疗和手术的技术领域和科学研究持续地朝着用更小的切口,或者经过脉管系统和身体开口的更小通路来治疗体内缺陷和疾病的方向发展。这种治疗的一个重要方面涉及,通过脉管系统中的通路,用导管在治疗部位放置治疗装置。这种过程的例子包括:穿腔血管成形术(tranluminal angioplasty)、放置支架来加强血管壁或者其它类似部分壁,以及使用脉管阻塞性装置(vasoocclusive devices)来治疗脉管系统中的缺陷。对于这种应用,本领域中的工作人员一直在开发新的和性能更好的系统。当与生物处理能力的发展相结合时,对提高介入治疗装置和系统性能的技术的需要在扩大。
已经能够有利地利用技术中的新近发展的、介入治疗的一个特殊领域是,神经血管缺陷(neurovascular defects)的治疗。更具体地,由于开发了更小的和性能更好的结构和材料,以前不可治疗的或者通过传统手术具有无法接受的风险的人脑中的脉管缺陷的治疗变得可行。
为了保持脉管的开放,支架典型地以收缩状态(contracted state)被植入进脉管中,而且,当进入脉管中适当位置的时候展开,这种支架典型地通过以下方法植入:通过把支架装到气囊导管(ballooncatheter)的气囊部分上,把支架放进人体内腔(body lumen)中,然后通过给气囊充气使支架展开到展开状态(expanded state)。然后,气囊被放气并移开,支架留在其位置上。然而,气囊导管的放置,充气和放气是复杂过程,其包含支架的植入之外的风险,所以,如果能提供一个支架,其能更简单地以收缩状态(compressed state)被放在要治疗的部位,然后展开来使得支架留在此部位,将是非常理想的。
众所公知,用聚合物记忆材料(polymeric memory materials)形成的很多支架能从收缩形态(compressed configuration)转变到展开形态(expanded configuration)。例如,公知的一种这样的传统支架提供由记忆弹性体制成的套管(casing),诸如聚氨基甲酸酯(polyurethane),以及可以通过将单条线编织起来制造的支撑结构,这些线由热敏聚氨基甲酸酯构成,热敏聚氨基甲酸酯在25℃以下是硬的,而在35℃以上变软,使得在稍微低于人体体温的温度下,支架从压缩形态(pressedconfiguration)转变为展开形态。
然而,由形状记忆聚合物材料构成的支架典型地不提供支架所需要的合适的结构和适当的径向机械强度。因此,支架普遍带有金属结构以提供其作为支架所需要的强度。因此,理想的是提供的形状记忆聚合物支架具有的状态能够提供作为支架所需要的合适的结构和适当的径向机械强度,并且不需要气囊导管的充气和放气而被部署,其部署是通过将处于收缩形态的支架推到要治疗的部位,在此部位支架能被展开,并将支架留在此部位。同时也希望,提供一种由形状记忆聚合物构成的支架,此形状记忆聚合物具有高于人体体温的玻璃化温度(glass transition temperature)(Tg),当此形状记忆聚合物暴露在体温下时,通过可控制地加热支架,此玻璃化温度使支架可控地从收缩形态转变到展开形态。本发明满足了这些和其他需要。
发明内容
简单而言,并且一般地,本发明提供一种支架,它由一种具有形状记忆特性的聚合物制造而成,因此其可以自展开(self expanding),因此减少对于人体的脉管组织内腔的损害。支架可以用在脉管系统中,作为防止血管再狭窄(restenosis)的装置,或者作为一个血管内流调节器(IFM,intravascular flow modifier),这在治疗脑动脉瘤和腹主动脉瘤方面非常有用。
因而,本发明在第一实施例中提供一种形状记忆聚合物支架,其包括具有桁架似构造(truss-like design)的挤压管(extruded tube),该挤压管由具有形状记忆特性的聚合物形成。在本发明的一个优选方案中,聚合物可以是聚氨基甲酸酯,其能从具有预定形状的最初展开形态被收缩成具有缩小的直径(reduced diameter)的形态,以与导管或者输送系统配合,并且在支架受热到其玻璃化温度之上以后,此聚氨基甲酸酯能回复到其预定形状和最初展开的直径(expanded diameter)。例如,支架能形成为挤压管,然后加工去除了部分,制造出为了提高径向强度的桁架似构造。
在另一个实施例中,本发明提供一种形状记忆聚合物支架,包括由具有形状记忆特性的聚合物制成的挤压带(extruded strands)编织而成的管。在本发明的一个优选方案中,聚合物可以是聚氨基甲酸酯,其能从具有预定形状的最初展开形态收缩成具有缩小的直径,以与导管或者输送系统配合,在支架受热到玻璃化温度之上以后,此聚氨基甲酸酯能回复到其预定形状和最初展开直径。
在每一个前述实施例中,当支架以其具有预定形状的展开形态形成之后,通过加热此支架到其玻璃化温度(Tg)之上,由形状记忆材料构成的此支架转变成橡胶态(rubbery state),并且其可以被收缩以在末端方向(distal direction)受轴向应力作用,从而使直径缩小和长度增加。在本发明的一个优选实施方案中,本发明的支架能被收缩在一个推送器导管(pusher catheter)的装配部分(mounting portion)上,以将其部署在脉管系统中。在一个优选的方案中,在支架任一端的推送器的外直径小于支架处于展开形态时的内直径,但是大于支架处于收缩形态时的内直径,同时,在其上放置支架的推进元件的装配部分的外直径具有减小的直径,其小于或者等于支架处于收缩形态时的内直径。
在支架处于伸长状态(elongated state)时,其可以被安装进导管或者其他输送系统中,用于输送经过脉管系统。由于支架由形状记忆材料形成,如果使其保持在Tg之上,它将回复到其原始形状和尺寸以释放收缩外应力。然而,在支架能够恢复到其原始形状和尺寸之前,通过将材料温度降低到Tg之下,它能被固定在收缩、伸长形态,并且被装到推送器导管的装配部分上。然后,装在推送器导管上的支架可以被插进脉管系统内并且移动到期望的位置中,然后热量可以从推送器导管传送到此支架,例如通过输送光能经过导热管、通过传导电流经过电阻、通过输送射频电磁波(radio-frequency electro-magneticwaves)或者超声波(ultra-sonic waves),或者其他方式。热传递使支架的温度再一次升高到Tg之上,并且导致支架转变回橡胶态,以径向展开并且轴向收缩到其原始形状和尺寸,将支架部署在脉管系统中,并且可以使推送器导管从脉管系统中收回。
从下面的具体描述和以示例性的方式说明本发明的附图中,本发明的这些和其他方案和优点将变得更清楚。
附图说明
图1是本发明的支架的第一实施例的平面视图,此支架由挤压管形成,并且被加工去除了部分,制造出桁架似的构造,其处于预定形状的原始展开形态。
图2是图1中的支架的端视图。
图3是图1中的支架的透视图。
图4是图1中的支架的透视图,其处于收缩、伸长形态。
图5是本发明的支架的另一个实施例的平面视图,此支架用挤压带编织而成,其处于预定形状的原始展开形态。
图6是图5中的支架的端视图。
图7是图5中的支架的透视图。
图8是图5中的支架的透视图,其处于收缩、伸长形态。
图9是图1中的支架的一个平面视图,其处于收缩、伸长形态并被装在推送器导管上以放进脉管系统中。
图10是图1中的支架的一个平面视图,其处于收缩、伸长形态并被装在推送器导管上以放进脉管系统中。
图11是图1中的支架的一个平面视图,显示部署在脉管系统中的支架处于展开形态,并且使推送器导管可以收回。
图12是图5中的支架的一个平面视图,其处于收缩、伸长形态并被装在图9中的推送器导管上以放进脉管系统中。
图13是图5中的支架的一个平面视图,显示部署在脉管系统中的支架处于展开形态,并且使推送器导管可以收回。
具体实施方式
众所公知,当由聚合物记忆材料构成的支架从收缩形态转变成展开形态时,由形状记忆聚合物材料(shape memory polymeric materials)构成的支架,典型地,不能提供其作为支架所需要的合适的结构和适当的径向机械强度,而且以前,支架用一种玻璃化温度(Tg)低于人体温度的形状记忆聚合物构成,这使得当这类支架被暴露于人体温度时,从收缩形态到展开形态的转变更加难于控制。
如在附图中所图解说明的,本发明以用于人体内腔中的治疗目标部位(target site)的形状记忆支架得以体现,或者以用于治疗动脉瘤,例如,脑动脉瘤或者腹动脉瘤的具有管形结构(tubular framework)的血管内流调节器(IFM)得以体现。参考图1-4,在本发明的一个优选实施例中,具有管形结构的形状记忆聚合物支架或者IFM 20,优选由多个环形支撑部分22(annular support members 22)和与所述多个环形支撑部分相交的多个交叉撑(cross-strut)24构成。参考图1和图2,形状记忆聚合物支架可以用挤压管形成,并且可以被加工去除部分,例如,使用激光在挤压管中切割出多个开口26(openings 26),以形成交叉的环形支撑部分和多个交叉撑,从而提供一种桁架似的构造。在本发明的一个优选实施例中,如图3中显示,此形状记忆聚合物是聚氨基甲酸酯,它可以获得具有展开直径的预定形状,比如,当加热到大于其Tg(玻璃化温度)以后有展开直径,例如,为3mm,并且其还可以具有缩小的直径,如图4中所示,例如大约为1mm,以适配导管或者输送系统。在本发明的一个优选实施例中,如在图1、3和4中所图解说明的,交叉撑是相对于多个环形支撑部分以一定的斜角延伸形成的。可替换地,交叉撑可以以其他角度形成,例如,与环形支撑部分以直角相交。
参考图5-8,在另一个实施例中,本发明提供一种编织支架或者血管内流调节器(IFM)30,其可以用挤压带编织以形成具有管形结构的形状记忆聚合物支架或者IFM。参考图5和6,编织形状记忆聚合物支架可以用挤压带编织,形成以交叉撑32作为纵向经线,和以支撑部分34作为环形纬线的支架,并且与带直角相交。可替换地,编织形状记忆聚合物支架或者IFM可以由形成纵向经线的挤压带,以及与带交叉的螺旋纬线编织而成。在本发明的一个优选实施例中,编织形状记忆聚合物支架由聚氨基甲酸酯构成,其可以获得预定形状,如图7中所示,具有展开直径,例如,在被加热到其Tg(玻璃化温度)以上之后,其展开直径为3mm,并且还可以具有收缩的直径,如图8中所示,例如大约为1mm,以与导管或者输送系统适配。
参考图9和图12,在本发明的方法中,挤压的形状记忆聚合物支架或者IFM20,或者编织形状记忆聚合物支架或者IFM30,以压缩、伸长形态,通过将其装在细长的推送器导管或推进元件42上,经过引入导管(introducer catheter)被引导进将要被治疗的血管目标部位,以放进血管中。为简单起见,推进元件的近端未显示。推进元件可以由光学纤维构件(fiber optic member)形成,其具有内部导光部分44(inneroptical conductor portion 44),以及外部缓冲层46(outer buffer layer 46)。如图9中所图解说明的,在细长推进元件的绝大部分长度,推进元件有基本外直径(DO1),并且光学纤维构件的末端区域至少有一部分外部缓冲层被去掉,以提供末端承托区域48(distal seating region 48),其具有凹进的外直径(OD2),此直径比基本外直径小,形状记忆聚合物支架能被装在其上。在本发明的一个优选实施例中,如图9所示,还可以在推进元件上提供一个或者多个不透射线的标记物50(radiopaque markers 50)。
参考图10和图12,为部署在脉管系统中,通过把细长推进元件的末端承托部分和被装在其上的管形形状记忆聚合物支架引导进入引入导管的内腔54中,将导管放置在血管或者其他人体内腔中,使得导管的末端开口接近于要被治疗的目标部位,然后,把携带着管形形状记忆聚合物支架的细长推进元件的末端承托部分从导管的末端开口56推出,进入到要被治疗的目标部位,将装在推进元件上的,处于收缩、伸长形态的挤压管形状记忆聚合物支架或者IFM20,或者编织形状记忆聚合物支架或者IFM30,放进人体内腔中,例如放进血管52中的一个狭窄处(stenosis)的目标位置上。如图11和图13中所图解说明的,挤压管或者编织管形形状记忆聚合物支架或者IFM,可以被加热以使形状记忆聚合物支架或者IFM转变到展开形态,由此将管形形状记忆聚合物支架部署在血管或者人体内腔的目标部位、或者部署在动脉瘤中,并且至少部分地闭塞在动脉瘤及其母体血管(parent blood vessel)之间的通路,并且可以收回推进元件。通过使能量在细长推进元件中传导,形状记忆聚合物支架或者IFM可以被加热,以解除推进元件和形状记忆聚合物支架或者IFM之间的连接。在本发明的一个优选的实施例中,推进元件包括光学纤维构件,以便管形形状记忆聚合物支架可以被加热,通过把光能通过光学纤维构件传导到达细长推进元件的承托区域以加热形状记忆聚合物支架或者IFM。可替换地,细长推进元件可以是热导管(heat pipe),并且形状记忆聚合物支架或者IFM可以被加热,通过使热量沿着热导管型细长推进元件传导到细长推进元件的承托区域以加热管形形状记忆聚合物支架。在另外一个替代实施例中,形状记忆聚合物支架或者IFM可以被加热,通过使电流通过电阻,发射射频电磁波(RF)或者超声波,或者其他类似的方式加热形状记忆聚合物支架或IFM。
从前面很明显地看出,本发明的特定形式已经被图解说明并描述,在不背离本发明的精神和范围的前提下,可以进行各种变换。因此,这些描述或图例的目的并不在于对本发明进行限制,本发明的保护范围以所附权利要求书为准。
Claims (31)
1.一种具有管形结构的形状记忆聚合物支架,包括:
多个环形支撑部分;和
多个交叉撑,这些交叉撑与所述多个环形支撑部分相交。
2.根据权利要求1所述的形状记忆聚合物支架,其中所述管形结构由挤压管形成,所述挤压管具有一个表面,所述表面形成所述多个环形支撑部分、所述多个交叉撑,以及在所述多个环形支撑部分和所述多个交叉撑之间的多个开口。
3.根据权利要求1所述的形状记忆聚合物支架,其中所述多个交叉撑相对于所述多个环形支撑部分成一斜角延伸。
4.根据权利要求2所述的形状记忆聚合物支架,其中所述挤压管由具有形状记忆特性的聚合物形成。
5.根据权利要求4所述的形状记忆聚合物支架,其中所述聚合物是聚氨基甲酸酯。
6.根据权利要求4所述的形状记忆聚合物支架,其中所述聚合物有玻璃化温度和预定形状,在加热到所述玻璃化温度之上以后,所述预定形状具有展开直径,并且所述预定形状还有缩小的直径,以与导管或者输送系统适配。
7.根据权利要求1所述的形状记忆聚合物支架,其中所述管形结构由所述多个环形支撑部分和所述多个交叉撑的编织带形成。
8.一种具有管形结构的形状记忆聚合物支架,其包括:
多个环形支撑部分;和
多个交叉撑,所述多个环形支撑部分与所述多个交叉撑交织成管形。
9.根据权利要求8所述的形状记忆聚合物支架,其中所述管形结构由所述多个环形支撑部分和所述多个交叉撑的编织带形成。
10.根据权利要求8所述形状记忆聚合物支架,其中所述多个交叉撑纵向延伸。
11.根据权利要求9所述的形状记忆聚合物支架,其中所述带由具有形状记忆特性的聚合物形成。
12.根据权利要求11所述的形状记忆聚合物支架,其中所述聚合物是聚氨基甲酸酯。
13.根据权利要求11所述的形状记忆聚合物支架,其中所述聚合物有玻璃化温度和预定形状,在加热到所述玻璃化温度之上以后,所述预定形状具有展开直径,并且具有缩小的直径,以与导管或者输送系统适配。
14.一种具有管形结构的血管内流调节器,其在治疗脑主动脉瘤和腹主动脉瘤中有用,所述血管内流调节器包括:
多个环形支撑部分;和
多个交叉撑,所述多个交叉撑与所述多个环形支撑部分相交。
15.根据权利要求14所述的血管内流调节器,其中所述管形结构由挤压管形成,所述挤压管具有一个表面,所述表面形成所述多个环形支撑部分、所述多个交叉撑,以及在所述多个环形支撑部分和所述多个交叉撑之间的多个开口。
16.根据权利要求14所述的血管内流调节器,其中所述多个交叉撑相对于所述多个环形支撑部分成一斜角延伸。
17.根据权利要求15所述的血管内流调节器,其中所述挤压管由具有形状记忆特性的聚合物形成。
18.根据权利要求17所述的血管内流调节器,其中所述聚合物是聚氨基甲酸酯。
19.根据权利要求17所述的血管内流调节器,其中所述聚合物有玻璃化温度和预定形状,在加热到所述玻璃化温度之上以后,所述预定形状具有展开直径,并且其还有缩小的直径,以与导管或者输送系统适配。
20.根据权利要求14所述的血管内流调节器,其中所述管形结构由所述多个环形支撑部分和所述多个交叉撑的编织带形成。
21.一种具有管形结构的血管内流调节器,其包括:
多个环形支撑部分;和
多个交叉撑,所述多个环形支撑部分与所述多个交叉撑交织成管形。
22.根据权利要求21所述的血管内流调节器,其中所述管形结构由所述多个环形支撑部分和所述多个交叉撑的编织带形成。
23.根据权利要求21所述的血管内流调节器,其中所述多个交叉撑纵向延伸。
24.根据权利要求22所述的血管内流调节器,其中所述带是由具有形状记忆特性的聚合物形成。
25.根据权利要求24所述的血管内流调节器,其中所述聚合物是聚氨基甲酸酯。
26.根据权利要求24所述的血管内流调节器,其中所述聚合物具有玻璃化温度和预定形状,在加热到所述玻璃化温度之上以后,所述预定形状具有展开直径,并且其还有缩小的直径,以与导管或者输送系统适配。
27.一种用于将形状记忆聚合物支架引导进入要治疗的血管内的目标部位中的方法,所述方法包括以下步骤:
提供具有末端和近端的细长推进元件,所述细长推进元件在其长度的大部分具有基本外直径,所述细长推进元件具有一个末端承托区域,所述承托区域具有的外直径小于所述基本外直径;
提供管形形状记忆聚合物支架,当温度在体温以下时,所述管形形状记忆聚合物支架具有收缩形态,而当温度在体温以上时,所述管形形状记忆聚合物支架具有展开形态,当被加热到高于体温的玻璃化温度以上的时候,在展开形态的所述管形形状记忆聚合物支架具有增大的内直径和外直径,所述增大的内直径比所述细长推进元件的所述基本外直径大,而在所述收缩形态的所述管形形状记忆聚合物支架具有缩小的内直径和外直径,它们分别小于所述管形形状记忆聚合物支架的所述增大的内直径和外直径,所述缩小的内直径大于所述细长推进元件的所述承托区域的所述外直径,而小于所述细长推进元件的所述基本外直径;
将处于所述收缩形态的所述管形形状记忆聚合物支架装在所述细长推进元件的所述承托区域上,以把所述管形形状记忆聚合物支架套在所述细长推进元件的所述承托区域上;
将所述细长推进元件的所述末端承托部分以及装在其上的所述管形形状记忆聚合物支架引导进入导管的内腔中;
将所述导管定位所述脉管系统内,使得所述导管的所述末端开口邻近要被治疗的所述血管的所述目标部位;
将携带着所述管形形状记忆聚合物支架的所述细长推进元件的所述末端承托部分推出所述导管的所述末端开口,进入要被治疗的所述血管的所述目标部位;
加热所述管形形状记忆聚合物支架以使所述管形形状记忆聚合物支架转变到所述展开形态,由此把所述管形形状记忆聚合物支架部署在动脉瘤中,并且至少部分地闭塞所述动脉瘤与其母体血管之间的通路。
28.根据权利要求27所述的方法,其中加热所述管形形状记忆聚合物支架的所述步骤包括使能量通过所述细长推进元件传输,以解除所述推进元件与所述管形形状记忆聚合物支架之间的连接。
29.根据权利要求27所述的方法,其中所述细长推进元件是光学纤维,所述加热步骤包括将光能传导到所述细长推进元件的所述承托区域,以加热所述管形形状记忆聚合物支架。
30.根据权利要求27所述的方法,其中所述细长推进元件是导热管,所述加热步骤包括沿着所述细长推进元件将热量传导到所述细长推进元件的所述承托区域,以加热所述管形形状记忆聚合物支架。
31.根据权利要求27所述的方法,其中所述加热步骤包括用RF能量加热所述管形形状聚合物支架。
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US10/145,387 US20030216804A1 (en) | 2002-05-14 | 2002-05-14 | Shape memory polymer stent |
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EP (2) | EP2581064A1 (zh) |
JP (1) | JP2005525195A (zh) |
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CN (1) | CN1652733A (zh) |
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CA (1) | CA2480179A1 (zh) |
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CN111347459A (zh) * | 2018-12-20 | 2020-06-30 | 哈尔滨工业大学 | 一种基于4d打印的空间可伸缩机械臂及其伸缩方法 |
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EP2581064A1 (en) | 2013-04-17 |
ES2431837T3 (es) | 2013-11-28 |
US20030216804A1 (en) | 2003-11-20 |
AU2003269987A1 (en) | 2003-12-02 |
KR20040106533A (ko) | 2004-12-17 |
CA2480179A1 (en) | 2003-11-27 |
JP2005525195A (ja) | 2005-08-25 |
EP1503701B1 (en) | 2013-08-21 |
WO2003096934A1 (en) | 2003-11-27 |
EP1503701A1 (en) | 2005-02-09 |
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