CN114732470A - 栓塞装置及其制造方法 - Google Patents
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Abstract
本发明涉及栓塞装置及其制造方法。本发明具体公开了一种扁平栓塞编带(10),其具有包括第一侧表面(14)的第一侧和包括面向与第一侧表面相反方向的第二侧表面(16)的第二侧,该编带具有用于通过递送导管展开的伸长的受约束结构,和三维无约束结构,其中在三维无约束结构中,该编带呈现多个连续的环(12),其中编带在该多个连续的环之间至少部分扭转,使得无论编带的方向和/或取向的变化,分别使第一侧表面面向每个环的外侧,并且第二侧表面面向每个环的内侧。
Description
本申请是申请日为2016年12月28日的题为“栓塞装置及其制造方法”的中国专利申请No.201680074865.X的分案申请。
技术领域
本文中公开的发明涉及栓塞装置。更具体地,本公开涉及制造栓塞装置的方法。
背景技术
如线圈,管状织网元件和其他可扩展元件的医疗装置,以下统称为“栓塞装置”,通常用于治疗各种类型的血管缺陷,特别是动脉瘤。动脉瘤是由疾病,血管中施加的血流/压力和/或血管壁的弱化引起的血管的局部化的充满血液的扩张。动脉瘤通常呈现从血管延伸的囊状或气球状结构。动脉瘤可能破裂并引起出血,中风(例如,颅内动脉瘤)和其他对患者造成的损害的后果。在治疗动脉瘤期间,将栓塞装置以塌陷或径向压缩的递送结构载入到递送系统上,而随后引入动脉瘤囊中。一旦递送到动脉瘤囊内,则栓塞装置可以扩张或扩张成填充和闭塞动脉瘤的膨胀结构。栓塞装置可以具有各种尺寸和形状;然而,用于治疗动脉瘤的栓塞装置在动脉瘤囊内展开时通常呈现球形的二级结构。当植入囊内时,栓塞装置可以进一步增强动脉瘤囊的内壁,而同时阻塞动脉瘤,降低动脉瘤破裂的可能性或防止动脉瘤的进一步破裂。
栓塞装置通常由自膨胀材料构成,使得在装置从递送系统展开到患者中的靶位置时,不受约束的装置膨胀而不需要任何辅助。自膨胀栓塞装置可以是偏置的,使得从递送导管释放时膨胀,和/或包括允许装置在暴露于预定条件时膨胀的形状记忆组件。一些栓塞装置可以表征为具有自膨胀材料和非自膨胀材料的某些特性的混合装置。
栓塞装置可以由各种材料制成,包括聚合物(例如,非生物可蚀性和生物可蚀性塑料)和金属。生物可蚀性聚合物栓塞装置由于它们的可生物降解性和相比于金属栓塞装置通常增加的柔韧性而对于某些应用是期望的。栓塞装置可以由形状记忆或超弹性材料,如形状记忆金属(例如,形状记忆镍钛诺)和聚合物(例如,聚氨酯)制成。这种形状记忆栓塞装置可以在递送到治疗部位之后诱导(例如,通过温度,电或磁场或光)而呈现形状(例如,径向扩张的形状)。超弹性栓塞材料,如超弹性镍钛诺,在递送后会呈现形状而不需要诱导性刺激。其他装置材料包括不锈钢,铂和埃尔吉洛伊非磁性合金(Elgiloy)。在药物递送栓塞装置中,装置可以携带和/或装置的表面可以涂覆有生物活性剂或治疗剂(例如,血栓形成诱导剂)。
常用的栓塞装置是螺旋线圈,其具有尺寸设为接合动脉瘤壁的绕线。尽管如此,栓塞线圈特别是当递送至较宽的颈部动脉瘤时可能从动脉瘤囊中迁移出来。
例如,美国专利号4,994,069中描述了一些示例性的栓塞线圈,其公开的一种栓塞线圈在拉伸时呈现线性螺旋结构而在松弛时呈现折叠的盘绕结构。拉伸的结构用于将线圈置于靶位置(通过其穿过递送导管),并且一旦装置在靶部位展开,则线圈呈现盘绕的松弛结构。'069专利公开了当展开于靶部位时栓塞线圈的各种二级形状,如“花”形,双涡旋,和随机盘绕形状。其它三维栓塞线圈已经描述于美国专利号5,624,461(即,三维填充栓塞线圈),5,639,277(即,具有扭转的螺旋形状的栓塞线圈)和5,649,949(即,可变横截面的圆锥形栓塞线圈)中。具有很少或没有固有的二级形状的栓塞线圈也已经描述于如美国专利号5,690,666和5,826,587中。
球形栓塞装置描述于美国专利号5,645,558中,其公开了当展开于动脉瘤中时,一根或多根线股可以盘绕而形成包括重叠的线股的基本中空的球形或卵形形状。在美国专利号8,998,947中描述了在展开时呈现球形形状的其他栓塞装置,其公开了具有花瓣状部分的管状织网,在展开于动脉瘤中时形成具有重叠的花瓣状部分的基本呈球形的形状。
用于栓塞装置的各种递送组件是已知的。例如,Guglielmi的美国专利号5,250,071(即,互锁卡扣(clasp)),5,312,415(即,递送多个线圈的互连导丝)以及5,354,295和6,425,893(即,电解脱离)。
发明内容
在公开的本发明的示例性实施方式中,栓塞装置由具有纵轴,包括第一侧表面的第一侧和包括第二侧表面的第二侧的细长扁平部件形成,第一和第二侧表面彼此反向,且第一侧面和第二侧面面向相反的方向。细长扁平部件具有用于通过递送导管展开至靶的血管部位的细长受约束结构和三维的无约束结构,其中在三维无约束结构中,细长扁平部件呈现多个连续的环,其中细长扁平部件在多个环的每个之间至少部分围绕其纵轴扭转,使得无论细长扁平部件的方向和/或取向的变化,第一侧表面面向每个环的外侧,第二侧表面面向每个环的内侧。
不受限制,细长扁平部件可以是由一个或多个编结部件形成的编带,其中一个或多个编结部件是金属丝或金属线。例如,细长扁平部件可以是扁平化的管状编带或单层扁平带状编带。
在示例性实施方式中,通过热处理细长扁平部件而给予细长扁平部件三维无约束结构,同时细长扁平部件围绕从芯轴向外延伸的相应的柱以交替的方向缠绕,由此形成多个连续的环。在优选实施方式中,多个连续的环包括限定第一平面的至少第一环,限定不与第一平面共面的第二平面的第二环,和限定不与第一或第二平面共面的第三平面的第三环。在一个示例性实施方式中,多个连续的环包括至少五个连续的环。
在更具体的示例性实施方式中,提供了用于闭塞动脉瘤的栓塞装置,栓塞装置包括由一根或多根金属编结丝或线形成的细长扁平编带,并具有纵轴、包括第一侧表面的第一侧和包括第二侧表面的第二侧,第一侧和第二侧彼此反向,并且第一侧表面和第二侧表面面向相反的方向。细长扁平编带具有用于通过递送导管展开至动脉瘤中的细长受约束的结构,和在从递送导管展开至动脉瘤内之后的三维无约束结构,其中在三维无约束结构中,细长扁平编带呈现多个连续的环,其中细长扁平编带在多个环的每个之间围绕其纵轴至少部分扭转,使得无论细长扁平编带的方向和/或取向变化,分别使第一侧表面朝着动脉瘤的内壁面向每个环的外侧,且第二侧表面面向每个环的内侧。
通过举例的方式,细长扁平编带可以是扁平化的管状编带或单层的带状编带,其中通过热处理细长扁平编带,同时将细长扁平编带围绕从芯轴向外延伸的相应的柱以交替方向缠绕而由此形成多个连续的环而赋予于细长扁平编带三维无约束结构。多个连续的环优选包括至少三个连续的环,包括限定第一平面的第一环,限定不与第一平面共面的第二平面的第二环和限定不与第一或第二平面共面的第三平面的第三环。在一个实施方式中,多个连续的环包括至少五个连续的环。
鉴于附图,由随后的详细描述,这些实施方式的其他和进一步的方面和特征将变得显而易见。
附图说明
图1是根据公开的发明的实施方式制造的栓塞装置的透视图;
图2A-图2B是根据公开的发明的实施方式,图1的栓塞装置在靶位置的递送和展开结构的横截面视图。
图3A-图3B是根据公开的发明的实施方式,用于制造图1的栓塞装置的细长扁平部件的透视图和横截面视图;
图4A-图4B是根据公开的发明的实施方式,图3A的细长扁平部件的横截面视图;
图5A-图5C是根据公开的发明的其他实施方式,细长扁平部件的侧视图;
图6A-图6C是根据公开的发明的实施方式,图5B的实施方式的端部的侧视图;
图7A-图7B是根据公开的发明的另一个实施方式,细长扁平部件的透视图;
图8A-图8B是根据公开的发明又一个实施方式,细长扁平部件的透视图;
图9是根据公开的发明的实施方式,在用于制造图1的栓塞装置的芯轴中图3A的细长扁平部件的透视图;
图10是根据公开的发明的实施方式,用于制造图1的栓塞装置的另一种芯轴中图3A的细长扁平部件的透视图;
图11是根据图9和图10的实施方式的细长扁平部件的部分扭转的透视图;
图12是出于说明目的的细长扁平部件的扭转的透视图;和
图13是据公开的发明的实施方式,制造图1的栓塞装置的方法的示意图。
具体实施方式
对于以下定义的术语,除非在本说明书的其他地方给出了不同的定义,这些定义应该适用。
在本文中,无论是否明确指出,假定所有数值都由术语“约”修饰。术语“约”通常是指本领域技术人员会认为与引述的值等同(即具有相同功能或结果)的数值范围。在许多情况下,术语“约”可以包括四舍五入到最接近的有效数字的数。
通过端点引述的数值范围包括该范围内的所有数值(例如,1至5包括1,1.5,2,2.75,3,3.80,4和5)。
如在本说明书中使用的,除非上下文另有明确规定,否则单数形式“一个”,“一种”和“该”包括复数指代物。如在本说明书中使用的,术语“或”除非上下文另有明确规定,通常以其包括“和/或”的意义使用。
下文参照附图要描述各个实施方式。附图不一定按比例绘制,为了清楚,选择的元件的相对比例可以是放大的,并且在整个附图中,类似结构或功能的元件由相同的标号表示。还应该理解的是,附图仅旨在便于描述实施方式,而并不旨在作为对本发明的详尽描述或作为对仅由所附权利要求及其等同物限定的本发明的范围的限制。另外,说明的实施方式不需要具有所示的所有方面或优点。即使没有如此阐明,结合具体实施方式描述的方面或优点不一定限于该实施方式,并可以在任何其他实施方式中实践。
图1示出了根据公开的发明的实施方式的栓塞装置10。栓塞装置10包括用于通过递送导管80展开至靶向的血管部位20(例如,动脉瘤囊)的细长约束结构(图2A)。栓塞装置10进一步包括三维无约束结构(图1和图2B),其中装置10呈现多个连续的环12。例如,装置三维无约束结构在装置10从递送导管80的远侧开口82伸出,和/或递送导管80相对于栓塞装置10(或每个中的一些)向近侧撤回到靶向的血管部位20中之后呈现(图2B)。三维无约束结构通过对细长扁平部件100施加一系列制造步骤设定,以包括连续环12,其中细长扁平部件100在多个环中的每个之间至少部分围绕其纵轴扭转,使得无论细长扁平部件100在方向和/或取向上的变化,分别使第一侧表面14朝向动脉瘤20的内壁22面向每个环12的外侧,且第二侧表面16面向每个环12的内侧11(图1,图2B)。多个连续的环12可以包括限定第一平面的第一环,限定不与第一平面共面的第二平面的第二环,和限定不与第一平面或第二平面共面的第三平面的第三环,如图1和图2B所示。在一些实施方式中,多个连续的环包括至少五个连续的环12,如图2B所示。
下面将进一步详细描述细长扁平部件100的一系列制造步骤用于设定栓塞装置10的三维无约束结构的应用。
如图3A中所示,形成栓塞装置10的细长扁平部件100具有近侧部分140,中间部分130和远侧部分120。近侧部分140包括近端142,而远侧部分120包括远端122。细长扁平部件100包括具有矩形横截面的带状结构,如图3A和图3B所示。可替换地,细长扁平部件100可以具有任何其他合适的横截面,例如:卵形或椭圆形(图4A),扁平且具有圆形边缘(图4B),扁平化的管状(图7B)横截面等,或它们的组合。细长扁平部件100进一步包括纵轴13,包括第一侧表面14的第一侧4和包括第二侧表面16的第二侧6,第一侧4和第二侧6彼此反向,而第一侧表面14和第二侧表面16面向相反的方向,如图3A所示。
为了便于图示,图3A-图3B中所示的细长扁平部件100由具有带状结构的材料的单层40构成。材料的单层40可以是多孔的和/或可渗透的,例如,由多根编结线50或编织丝50'形成的层40(图5A),网55(图5B),和/或具有穿孔57的材料的层40(图5C)等,或它们的组合。线50和/或丝50'由生物相容性金属和/或聚合物材料、合金或它们的组合构成。例如,一根或多根线50可以具有铂芯,带有各自的镍钛诺的外层。在一些实施方式中,细长扁平部件100包括单层的扁平带状编带。当细长扁平部件100编结,织造或结网时,近端142和/或远端122可以被固定,在各自的近端142和/或远端122处通过粘合剂,夹具等使多根线50附接或连接至彼此或另一元件(例如,帽,非损伤性尖端等),如图6A中的远端122处所示。可替换地,细长扁平部件100的近端142和/或远端122可以是未固定的,使多根线50在各自的近端142和/或远端122处松开且自由,如图6B中远端122处所示。此外,线圈123可以连接至细长扁平部件100的固定的近端142和/或远端122,如图6C中的远端122处所示。当栓塞装置10处于三维无约束结构时,线圈123可以由形状记忆材料构成,并且可以呈现环状结构,如栓塞装置10的环12。线圈123在布置于细长扁平部件100的远端122处时配置为在动脉瘤20内展开时引导栓塞装置。
在一些实施方式中,细长扁平部件100包括由一个或多个编结部件形成的编带,且一个或多个编结部件是金属丝或线。
在进一步的实施方式中,材料的单层40可以是无孔的或材料的不可渗透的层(例如,实心的),如图3A所示。应该理解的是,细长扁平部件100的单层40可以包括一种或多种材料,其组合的合金。
在其他实施方式中,细长扁平部件100可以由多个层42构成(例如,图7A);如上描述的,这些层可以是多孔的/可渗透的,无孔的/不可渗透的和/或包括一种或多种材料,或其组合。由多个层42构成的细长扁平部件100可以具有图3A的扁平带状结构。作为非限制性实例,细长扁平部件100可以包括管状部件150,如图7A所示,管状部件150可以包括扁平化的编带或网,形成图3A的类似的扁平带状结构,如扁平管状编带,如图7B所示。管状部件150在扁平化为带状结构时包括至少两个层42,如图7B所示。在另一个示例性实施方式中,细长扁平部件100可以由圆柱形部件160构成,如图8A所示,其扁平化以形成图3A的类似的扁平带状结构,如图8B所示。圆柱形部件160可以由一种或多种材料或其组合构成。图8A-图8B的圆柱形部件160进一步可以包括芯162和外层164。作为非限制性示例,芯162可以由铂构成而外层164可以由镍钛诺构成。
应该理解的是,细长扁平部件100可以使用多种技术,包括激光切割或将将图案蚀刻到管或片材上,或其他合适的技术由线编结,由管切割,或由片材切割。应该进一步理解,细长扁平部件100的其他合适结构可以考虑用于制造栓塞装置10。
返回参考图3A,细长扁平部件100包括约2至40厘米范围内的长度L1,并且在一些实施方式中,L1范围为约5至25厘米。细长扁平部件100进一步包括约0.5至10毫米范围内的宽度W1,而在一些实施方式中,W1范围为约1至3毫米。另外,细长扁平部件100包括约0.05至0.75毫米范围内的厚度T1,而在一些实施方式中,T1范围为约0.1至0.4毫米。在一些实施方式中,细长扁平部件100的一个或多个尺寸(L1,W1或T1)在整个部件100中保持恒定,使得从近侧部分140到远侧部分120具有相同的尺寸。在其他实施方式中,细长扁平部件100的一个或多个尺寸(L1,W1或T1)可以变化,沿着细长扁平部件100的长度具有不同尺寸(例如锥形结构)。
细长扁平部件100可以由任何数量的生物相容性、可压缩、弹性的材料或其组合构成,包括聚合材料,金属和金属合金,如不锈钢,钽或镍钛合金,如称为镍钛诺的超弹性镍钛合金。某些超弹性合金由于其形状可恢复特性而可以是期望的,其即使用于小尺寸的细长扁平部件100中时也容许显著弯曲而不变形。此外,当栓塞装置10包括由自膨胀材料构成的细长扁平部件100时,无约束的栓塞装置10偏置为扩张成预定的展开结构,这将在下面进一步详细描述。一些超弹性合金包括镍/钛合金(48-58原子%的镍和可选地含有适量的铁);铜/锌合金(38-42重量%的锌);含有1-至10重量%的铍、硅、锡、铝或镓的铜/锌合金;或镍/铝合金(36-至38原子%的铝)。
细长扁平部件100可以包括不透射线的标记物或涂覆有不透射线的材料的层。另外,细长扁平部件100可以携带和/或细长扁平部件100的表面可以涂覆有生物活性剂或治疗剂(例如血栓形成诱导剂)。
用于细长扁平部件100的其他合适的金属和合金包括铂族金属,如铂,铑,钯,铼,以及钨,金,银,钽和这些金属的合金,如铂/钨合金等或它们的组合。这些金属具有显著的不透射线性,并且在它们的合金中可以定制为实现柔性和刚性的合适共混。
图9示出了根据公开的发明的实施方式,包含细长扁平部件100并使用芯轴200制造的图1的栓塞装置10。细长扁平部件100布置于芯轴200上。芯轴200包括从近端部分240延伸到远端部分220的柄杆210。芯轴200的远端部分220包括多个延伸柱230,232,233,234,236和238。柄杆210和横向延伸柱230,232,233,234,236和238包括具有圆形横截面的圆柱形或管状结构。可替换地,柄杆210和横向延伸柱230,232,233,234,236和238可以包括任何其他合适的结构,如例如具有椭圆形横截面。延伸柱230,232,233,234,236和238从柄杆210的远端部分220向外延伸,并围绕柄杆210的远端部分220环绕设置。每个延伸柱230,232,233,234,236和238包括各自的中心点(例如,238'),其中每个延伸柱相对于相邻柱中心点以合适的角度(例如,约65至95度)设置,如图9中所示。在替代实施方式中,芯轴200可以包括四个延伸柱,其中每个延伸柱相对于相邻柱的中心点(未显示)以约90度设置。应当理解的是,芯轴200可以包括任何数量的延伸柱,延伸柱之间的任何角度数(例如,柱可以彼此之间对称或非对称设置),或用于制造栓塞装置10的任何其它合适的结构,如例如图10的芯轴200'。图10的芯轴200'包括扁平基部240和从基部240向外延伸的多个延伸柱250,251,252,253,254,255和256。
通过靠芯轴200放置细长扁平部件100,具体地第一侧表面14或第二侧表面16中的任一个,将细长扁平部件100布于芯轴200上。例如,当细长扁平部件100的第一侧表面14靠芯轴200放置,布于芯轴200上,或与芯轴200接触时,第二侧表面16暴露并可见于栓塞装置10的技术人员(即,不接触芯轴200),未显示。相反,当细长扁平部件100的第二侧表面16靠芯轴200放置,设置于芯轴200上,或与芯轴200接触时,细长扁平部件100的第一侧表面14暴露并可见于制造栓塞装置10的技术人员(即,不接触芯轴200),如图9和图10所示。
在栓塞装置10的三维无约束结构中,细长扁平部件100呈现多个连续的环12,其中细长扁平部件100在多个环的每个之间至少部分围绕其纵轴扭转,使得无论细长扁平部件100的方向和/或取向上的变化,分别使第一侧表面14面向每个环12的外侧,第二侧表面16面向每个环12的内侧。栓塞装置10的三维无约束结构通过以下设置:将细长扁平部件100设置并缠绕于芯轴(例如,图9和图10)中而形成多个连续的环12,在形成多个环中的每个的芯轴的每个柱之间围绕其纵轴至少部分扭转细长扁平部件100,使得无论细长扁平部件100的方向和/或取向上的变化,分别使第一侧表面14面向每个柱和/或环的外侧,第二侧表面16面向每个环的内侧并至少部分与每个柱接触,如图9和图10所示。
在公开的发明的实施方式中,细长扁平部件100在每个环之间和/或每个柱之间围绕其纵轴的至少部分扭转详细描绘于图11中。细长扁平部件100围绕纵轴的部分扭转为约120°,使得当栓塞装置10处于三维无约束结构时,无论细长扁平部件100的方向和/或取向上的变化,分别使细长扁平部件100的第一侧表面14面向每个环12的外侧,细长扁平部件100的第二侧表面16面向每个环的内侧,如图1和图2B所示。应该理解的是,在栓塞装置10的三维无约束结构中,无论细长扁平部件100的方向和/或取向上的变化,只要分别使细长扁平部件100的侧表面之一(例如,第一侧表面14)面向每个环12的外侧,且细长扁平部件100的反向侧表面(例如,第二侧表面16)面向每个环12的内侧11,部分扭转可以包括围绕细长扁平部件100纵轴的其它合适角度。
此外,连续的环12之间的扭转的角度可以表示为每单位长度存在一定扭转角量的节距。扭转节距优选地与相邻的环12的直径相关,其中节距为约1至2乘360°/πD,其中D是相邻环12的平均曲线直径。扭转节距可以在约0.25至约4乘以(360°/πD)间变化,并且在一些实施方式中,扭转节距可以为在约0.75倍至约2.5乘以(360°/πD)间变化。在一个实施方式中,形成栓塞装置10的三维无约束结构的细长扁平部件100的扭转通常以细长扁平部件100的整个扭转中具有恒定的横截面发生。可替换地,扭转可以发生于细长扁平部件100的横截面在整个扭转中变化的情况下。
为了说明目的,图12描绘了细长扁平部件100在每个环之间和/或每个柱之间围绕其纵轴的不期望的部分扭转(例如,60°),因为这种扭转将导致细长扁平部件100的第一侧表面14在交替的环中面向外侧和内侧,且细长扁平部件100的第二侧表面16也将在交替的环中面向外侧和内侧。
在下面将进一步详细描述根据公开的发明在芯轴200上设置,放置,缠绕和/或扭转细长扁平部件100的步骤。在细长扁平部件100设置于芯轴200上,形成栓塞装置10的三维结构之后,将栓塞装置10热处理,同时细长扁平部件100围绕从芯轴向外延伸的各自的柱以交替方向缠绕,由此形成多个连续的环12。如上描述的通过热处理细长扁平部件100赋予栓塞装置10的三维无约束结构,使得装置10偏置为呈现三维无约束结构,如图1和图2B中所示。芯轴200由具有允许栓塞装置10的热处理的足够的耐热性的材料构成。芯轴200通常包含如氧化铝或氧化锆的耐火材料,或任何其他合适的耐热材料。
图13描绘了根据公开的发明的实施方式,使用上述细长扁平部件100和芯轴200的栓塞装置10的制造方法300。
在步骤302中,将细长扁平部件100的近端142或远端122首先设置于芯轴200上,而使第一表面14或第二表面16与芯轴200接触。作为非限制性实例,细长扁平部件100的近端142依靠设置于延伸柱230,232,233,234,236和238近侧的的柄杆210布置,使一部分的第二侧表面16与芯轴200接触,如图9中所示。
在步骤304中,细长扁平部件100围绕其纵轴部分扭转,并进一步围绕第一延伸柱设置形成环,而使第一侧面面向外侧(例如,远离柱),而第二侧面面向内侧(例如,朝向或部分接触柱)。例如,细长扁平部件100延伸使得部分扭转并沿顺时针方向围绕第一延伸柱230缠绕,使一部分的第二侧表面16与延伸柱230接触,如图9中所示。
在步骤306中,细长扁平部件100围绕其纵轴部分扭转,并进一步围绕第二延伸柱设置形成环,使得第一侧面面向外侧(例如,远离柱),而第二侧面面向内侧(例如,朝向或部分接触柱)。如图9所示,细长扁平部件100经过延伸使得部分扭转并沿逆时针方向围绕第二延伸柱232缠绕,使一部分的第二侧表面16与第二延伸柱232接触。
在步骤308中,将细长扁平部件100围绕其纵轴部分扭转,并进一步围绕第三延伸柱设置形成环,使得第一侧面面向外侧(例如,远离柱),而第二侧面面向内侧(例如,朝向或部分接触柱)。如图9中所示,细长扁平部件100经过延伸使得部分扭转并沿顺时针方向围绕第三延伸柱233缠绕,使一部分的第二侧面16与第三延伸柱233接触。
在步骤310中,细长扁平部件100围绕其纵轴部分扭转,并进一步围绕第四延伸柱设置形成环,而使第一侧面面向外侧(例如,远离柱),而第二侧面面向内侧(例如,朝向或部分接触柱)。如图9中所示,细长扁平部件100延伸使得部分扭转并沿逆时针方向围绕第四延伸柱234缠绕,使一部分第二侧面16与第四延伸柱234接触。
在步骤312中,细长扁平部件100围绕其纵轴部分扭转,并进一步围绕第五延伸柱设置形成环,而使第一侧面面向外侧(例如,远离柱),而第二侧面面向内侧(例如,朝向或部分接触柱)。例如,细长扁平部件100延伸使得部分扭转并沿顺时针方向围绕第五延伸柱236缠绕,使一部分的第二侧表面16与延伸柱236接触,如图9中所示。
在步骤314中,细长扁平部件100围绕其纵轴部分扭转,并进一步围绕第六延伸柱设置形成环,使得第一侧面面向外侧(例如,远离柱),而第二侧面面向内侧(例如,朝向或部分接触柱)。如图9中所示,细长扁平部件100延伸使得部分扭转并沿逆时针方向围绕第六延伸柱238缠绕,使一部分第二侧面16与第六延伸柱238接触。
在步骤316中,将细长扁平部件100热处理,提供栓塞装置10的三维无约束结构,如图1和图2B中所示。
在步骤316之前的可选步骤318中,细长扁平部件100可以进一步部分扭转并围绕柄杆和/或延伸柱以交替的顺时针方向和逆时针方向设置,使细长扁平部件100的表面至少部分与延伸柱和柄杆接触。
应该理解的是,在步骤302至316中,细长扁平部件100从芯轴200的一个柱到另一个柱的转移是不连续的,以波状形式的,使得细长扁平部件100的侧表面之一(例如,16)至少部分接触芯轴200,同时相反的侧表面(例如,14)是自由的,可见的,或暴露的(即不接触芯轴200)。
由上述制造步骤产生的栓塞装置10包括具有多个连续环的三维无约束结构,其中细长扁平部件100在多个环中的每个之间围绕其纵轴至少部分扭转,使得无论细长扁平部件的方向和/或取向的变化,分别使第一侧表面面向每个环的外侧,第二侧表面面向每个环的内侧,如图1和图2B中所示。在制造步骤期间设置于芯轴200上的细长扁平部件100的侧表面(例如,表面16)面向每个环12的内侧11(例如,凹面部分),同时在制造步骤期间不接触芯轴200的细长扁平部件100的侧表面(例如,表面14)面向三维无约束结构中的栓塞装置10的每个环12的外侧(例如,凸面部分),如图1和图2B所示。
栓塞装置10的三维无约束结构的特征提供了几个重要的优点,例如,用作旨在用于小直径部位,如神经血管动脉瘤的栓塞装置。首先,因为栓塞装置10包括不连续的过渡区域(例如,环,部分扭转),栓塞装置10可以迫使进入高度压缩或收缩的状态,而弯曲或应力相对较小。这与具有尖锐的扭转,弯曲或转弯而由于其相对粗糙的过渡区域而导致包裹不充分且不能紧密压缩的栓塞装置形成相反。类似地,具有尖锐扭转、弯曲或转弯的栓塞装置的重叠部分上的应力,特别是在通过曲折的血管路径移动期间,可能会产生栓塞装置与递送系统的更多接触点和摩擦,具有不期望的效果(例如,栓塞装置的展开更慢,栓塞装置金属疲劳等)。
此外,当栓塞装置10通过递送导管80展开至动脉瘤20中并展开出动脉瘤内的递送导管80之后呈现三维无约束结构(图2A-图2B)时,细长扁平部件100呈现多个连续的环12,其中细长扁平部件100在多个环12的每个之间围绕其纵轴至少部分扭转,使得无论细长扁平部件100的方向和/或取向上的变化,分别使第一侧表面14朝向动脉瘤20的内壁22面向每个环12的外侧,而第二侧表面16面向每个环的内侧11,使得装置10的第一侧表面14接合并接触动脉瘤20的内壁22,而不会使囊扩张或具有可能导致动脉瘤内壁22损伤或破裂的任何尖锐转弯或角度。
应该理解的是,根据公开的发明构造的栓塞装置10可以通过本领域中已知的方法展开至靶部位中。
虽然本文已经显示和描述了具体的实施方式,但本领域技术人员要理解的是,它们并不旨在限制本发明,并且对于本领域技术人员而言显而易见的是,可以在不脱离公开的发明的范围的情况下做出各种变化,置换和修改(例如,各个部件的尺寸,部件的组合),而公开的发明的范围仅由所附权利要求及其等同物限定。因此,说明书和附图应该被认为是说明性的而非限制性的意义。本文中显示和描述的各个实施方式都旨在覆盖公开的发明的替换,修改和等同物,其都可以包括于所附权利要求的范围内。
Claims (16)
1.一种栓塞装置,包括:
细长扁平部件,具有纵轴、包括第一侧表面的第一侧和包括第二侧表面的第二侧,所述第一侧和所述第二侧彼此反向,并且所述第一侧表面和所述第二侧表面面向相反的方向,
所述细长扁平部件具有用于通过递送导管展开至靶向的血管部位的伸长受约束结构和三维无约束结构,所述细长扁平部件由选自由以下组成的组的金属组成:铂族金属、铼、钨、金、银和钽,以及前述金属中任一项的合金,
其中在所述三维无约束结构中,所述细长扁平部件呈现多个连续的环,其中所述细长扁平部件在多个所述环的每个之间绕所述细长扁平部件的所述纵轴至少部分扭转,使得无论所述细长扁平部件的方向和/或取向的变化,分别使所述第一侧表面面向每个环的外侧,以及所述第二侧表面面向每个环的内侧,以及
其中多个环的第一环限定第一平面,并且与所述第一环紧邻的环限定第二平面,以及其中所述第一平面与所述第二平面形成65-95度的角。
2.根据权利要求1所述的栓塞装置,其中所述铂族金属选自由铂、铑和钯组成的组,以及其中铂族金属的合金选自由铂的合金、铑的合金和钯的合金组成的组。
3.根据权利要求1所述的栓塞装置,其中所述细长扁平部件包括完全由金铂合金丝或金铂合金线形成的编结网。
4.根据权利要求1所述的栓塞装置,其中所述细长扁平部件包括由一个或多个编结部件形成的编带。
5.根据权利要求4所述的栓塞装置,其中所述一个或多个编结部件是金属丝或金属线。
6.根据权利要求4或5所述的栓塞装置,其中所述细长扁平部件包括扁平化的管状编带。
7.根据权利要求4或5所述的栓塞装置,其中所述细长扁平部件包括单层的扁平带状编带。
8.根据权利要求1所述的栓塞装置,其中所述三维无约束结构通过热处理所述细长扁平部件,同时将所述细长扁平部件围绕从芯轴向外延伸的各自的柱以交替的方向缠绕而由此形成多个连续的环而赋予所述细长扁平部件。
9.根据权利要求1所述的栓塞装置,其中当从外朝向所述三维无约束结构的形心观察时,所述第一环的曲线的方向与相邻的环的曲线的方向相反。
10.根据权利要求1所述的栓塞装置,所述多个连续的环包括至少五个连续的环。
11.根据权利要求1所述的栓塞装置,其中在所述三维无约束结构中,所述细长扁平部件包括扭转节距。
12.根据权利要求11所述的栓塞装置,其中所述扭转节距为约1.5乘360°/πD,其中D是相邻的环的平均曲线直径。
13.根据权利要求11所述的栓塞装置,其中所述扭转节距在约0.25乘(360°/πD)至约4乘(360°/πD)间变化,其中D是相邻的环的平均曲线直径。
14.根据权利要求11所述的栓塞装置,其中所述扭转节距在约0.75乘(360°/πD)至约2.5乘(360°/πD)间变化,其中D是相邻的环的平均曲线直径。
15.根据权利要求1所述的栓塞装置,其中在所述三维无约束结构中,所述细长扁平部件包括在多个环的每个环之间的恒定截面。
16.根据权利要求1所述的栓塞装置,其中在所述三维无约束结构中,所述细长扁平部件包括在多个环的每个环之间的可变截面。
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US10743883B2 (en) | 2020-08-18 |
US20240032938A1 (en) | 2024-02-01 |
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ES2913227T3 (es) | 2022-06-01 |
WO2017117284A1 (en) | 2017-07-06 |
CN108472043A (zh) | 2018-08-31 |
CN108472043B (zh) | 2022-05-31 |
EP3397177A1 (en) | 2018-11-07 |
US11819217B2 (en) | 2023-11-21 |
JP2019502441A (ja) | 2019-01-31 |
JP6895437B2 (ja) | 2021-06-30 |
JP7195375B2 (ja) | 2022-12-23 |
US20170189035A1 (en) | 2017-07-06 |
EP3397177B1 (en) | 2022-03-30 |
EP4039201A1 (en) | 2022-08-10 |
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