CN104254289B - 阻塞装置 - Google Patents

阻塞装置 Download PDF

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CN104254289B
CN104254289B CN201380019992.6A CN201380019992A CN104254289B CN 104254289 B CN104254289 B CN 104254289B CN 201380019992 A CN201380019992 A CN 201380019992A CN 104254289 B CN104254289 B CN 104254289B
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aneurysm
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CN104254289A (zh
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M·莫莱
M·L·洛索多
A·内格斯瓦兰
S·格里芬
J·戴维森
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Nellcor Puritan Bennett LLC
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A61B17/12113Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214Coils or wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214Coils or wires
    • A61B17/1215Coils or wires comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027Type of occlusion
    • A61B17/12031Type of occlusion complete occlusion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A61B17/12113Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • A61B17/12118Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm for positioning in conjunction with a stent
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214Coils or wires
    • A61B17/12145Coils or wires having a pre-set deployed three-dimensional shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205Introduction devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205Introduction devices
    • A61B2017/12054Details concerning the detachment of the occluding device from the introduction device

Abstract

提供了一种动脉瘤治疗系统,其可以包括导管和阻塞装置。导管可以具有在其近端和远端之间延伸的腔体。阻塞装置可以布置在导管腔体内,并且配置成放置到动脉瘤中以限制流体在动脉瘤内流动。所述阻塞装置可以具有远侧区段,所述远侧区段包括具有外径、线圈长度、以及线圈挠性的线圈。所述阻塞装置也可以包括自身扩展的编织的近侧区段。编织的近侧区段可以被配置成在行进出导管的远端期间扩展,并且远侧区段可以被配置成沿线圈长度的至少一部分分配沿动脉瘤内壁的行进力。

Description

阻塞装置
技术领域
本公开涉及可植入装置。更特别地,本公开涉及一种阻塞装置,所述阻塞装置可以被植入血管内并且在一些实施例中用于动脉瘤治疗。
背景技术
已经提供多种栓塞装置以用于动脉瘤治疗。通常,编织球式栓塞装置、线圈、以及其他类型的栓塞装置通过中断血液流动并且随后形成血栓来操作。
发明内容
技术主题的附加特征和优点将在以下说明内容中列出,并且将从说明书中部分清楚,或可通过实践技术主题得知。所述技术主题的优点将通过在此书写的描述内容和实施例具体指出的结构以及附图实现和获得。
依据一些实施例,可以提供动脉瘤治疗系统和治疗动脉瘤的方法。所述系统可以包括导管和阻塞装置。导管可以具有近端、远端、以及在近端和远端之间延伸的腔体。阻塞装置可以被布置在腔体内,并且配置成放置到动脉瘤中以限制流体在动脉瘤内流动。
阻塞装置可以包括远侧区段和自身扩展的近侧部分。远侧区段可以包括具有外径、线圈长度、以及线圈挠性的线圈。而且,近侧区段可以具有:(i)当定位在输送腔体内时具有第一直径的径向压缩状态;(ii)当未约束时具有大于线圈直径的第二直径的径向扩展状态;(iii)大于线圈长度的编织物长度;和(iv)在每单位长度上小于线圈挠性的编织物挠性。
在一些实施例中,近侧区段可以被配置成在行进出导管的远端期间扩展,并且远侧区段可以被配置成沿线圈长度的至少一部分分配沿动脉瘤内壁的行进力。
而且,在一些实施例中,阻塞装置可以选择性地包括在近侧区段和远侧区段之间的过渡区段,所述过渡区段具有在每单位长度上比线圈挠性和编织物挠性更低的挠性。
远侧区段可以被配置成抵接动脉瘤内壁,以在近侧区段行进到动脉瘤中时引导最远的近侧区段。远侧区段可以包括弯曲的远端。例如,远侧区段的最大曲率半径可以小于近侧区段的最大曲率半径。
远侧区段可以被配置成在径向扩展状态下时具有二级的预设三维形状。在一些实施例中,近侧区段可以包括在第一平面内的第一弯曲部分和在第一平面外的第二弯曲部分。
例如,在一些实施例中,远侧区段可以包括预设的第一弯折部分和在预设的第一弯折部分远侧的远侧区段的第一部分,第一部分大致在第一平面内延伸。远侧区段也可以包括在第一弯折部分近侧布置的第二弯折部分。在第二弯折部分近侧的远侧区段的第二部分可以在不同于第一平面的第二平面中延伸。远侧区段还可以包括在第一弯折部分远侧布置的第三弯曲部分。在第三弯折部分远侧的远侧区段的第三部分可以在不同于第二平面的第三平面中延伸。
编织物长度可以从大约50mm到大约150mm。在一些实施例中,编织物长度可以从大约70mm到大约130mm。而且,编织物长度可以从大约90mm到大约100mm。编织物长度也可以是大约100mm。
线圈可以被配置成具有基本恒定的外径。而且,线圈长度可以从大约20mm到大约80mm。在一些实施例中,线圈长度可以从大约30mm到大约60mm。线圈长度也可以从大约35mm到大约50mm。而且,线圈长度可以是大约40mm。
在一些实施例中,当近侧区段在输送腔体中时,第一直径可以与线圈直径基本相同。第一直径可以从大约0.014英寸到大约0.034英寸。第一直径可以从大约0.016英寸到大约0.027英寸。在一些实施例中,第一直径可以从大约0.017英寸到大约0.021英寸。第二直径可以是第一直径的大约2倍到大约8倍。第二直径可以是第一直径的大约2.4倍到大约7倍。而且,第二直径可以是第一直径的大约2.8倍到大约5.8倍。
在一些实施例中,装置可以被配置成使得近侧区段的壁包括偏流孔尺寸。"偏流孔尺寸"可以指代孔的平均孔尺寸(在装置的至少一区段中),所述孔的平均孔尺寸充分小到足以妨碍或阻止流体通过所述区段的孔交换。
装置(例如,至少装置的近侧区段)可以具有活性区段或偏流区段,所述活性区段或偏流区段具有偏流孔尺寸,此时所述区段的孔的尺寸定为当管状部件定位在血管中并且邻近动脉瘤时阻止血通过侧壁流动到动脉瘤中的程度足以引起血栓形成并且治愈动脉瘤。
例如,当在偏流区段或活性区段中的孔在装置(例如,支架)处于扩展状态时具有小于大约500微米的平均孔尺寸时,可以实现偏流孔尺寸。在一些实施例中,平均孔尺寸可以小于大约320微米。而且,平均孔尺寸可以从大约25微米到大约350微米。平均孔尺寸也可以从大约40微米到大约200微米。而且,在一些实施例中,平均孔尺寸可以从大约60微米到大约150微米。此外,平均孔尺寸可以是大约120微米。
大约在这些范围内的平均孔尺寸可以操作成使流体流动偏移,并且在腔体内或被壁包封的内体积内引发血栓。所述孔可以具有大致恒定的孔尺寸。所述孔可以具有使用内切圆直径测量的平均孔尺寸。
此外,在一些实施例中,装置(例如,支架)可以设有范围在10%-95%中的孔隙度,可以在扩展的编织物中采用范围在10%-95%中的孔隙度以实现这些效果。在一些实施例中,可以采用范围在30%-90%中的孔隙度以实现这些效果。而且,可以采用范围在50%-85%中的孔隙度以实现这些效果。
系统也可以包括在近侧区段内延伸并且连接到近侧区段的成形部件。成形部件可以包括形成血栓的纤维。成形部件也可以包括螺旋形状。
例如,成形部件可以被连接到远侧区段的近端和远端。在压缩状态下,成形部件可以限定纵向长度,所述纵向长度在远侧区段处于压缩状态时大于远侧区段的纵向长度。而且,成形部件可以将向远侧区段的近端和远端施加伸长力。
选择性地,成形部件可以被连接到远侧区段的近端和远端,并且使近端和远端朝向彼此偏压,以协助扩展远侧区段。
系统也可以包括在近侧和远侧区段之间的过渡区段。过渡区段可以具有在每单位长度上比线圈挠性和编织物挠性更低的挠性。过渡区段也可以包括将近侧和远侧区段互连的管状或实心部件。
近侧区段可以包括近端和远端,并且远侧区段的远端可以被闭合。而且,近端也可以被闭合。
在一些实施例中,远侧区段可以包括细丝,所述细丝配置成当暴露于磁共振成像时产生热量从而促使血栓形成。
为了有助于输送和扩展,系统还可以包括推送线材,所述推送线材可拆卸地连接到阻塞装置的近端。而且,系统可以包括输送鞘,所述输送鞘被配置成容置阻塞装置并且将阻塞装置输送到动脉瘤中。输送鞘相对于阻塞装置是可缩回的,以允许阻塞装置在动脉瘤内扩展。
一些实施例也可以提供治疗动脉瘤的方法。例如,临床医生可以将在血管内的导管邻近动脉瘤定位。临床医生然后可以使阻塞装置的远侧区段从导管的远端行进。远侧区段可以包括具有线圈长度和线圈直径的线圈。临床医生也可以通过使近侧区段行进出导管的远端,将装置的近侧区段从当定位在输送腔体内时具有第一直径的径向压缩状态扩展成当未约束时具有大于线圈直径的第二直径的径向扩展状态。
而且,在一些实施例中,随着近侧区段行进出导管的远端,远侧区段可以沿线圈长度的至少一部分分配沿动脉瘤内壁的行进力。近侧区段可以包括在每单位长度上大于远侧区段挠性的挠性。
在所述方法的一些实施例中,使远侧区段行进可以包括使动脉瘤内壁与线圈的侧壁抵接。
而且,所述方法也可以包括使附加阻塞装置行进到动脉瘤中。例如,附加阻塞装置可以包括非扩展线圈或编织的装置中的至少一个。附加阻塞装置也可以具有小于近侧区段直径的直径。
在一些实施例中,装置的近侧区段可以被定位在动脉瘤内,以使得近侧区段的节段延伸跨过动脉瘤口,以阻止附加装置排出。
例如根据下述各种方面阐述技术主题。为了方便,所述技术主题的各个方面的各种示例以编号的款项(1、2、3,等等)描述。这些被提供作为示例并且不会限制技术主题。注意到的是,任何从属款项可以以任何组合方式被组合并且置于相应的独立款项中,例如,款项1或款项5。可以通过类似方式展示其他款项。
款项1.一种动脉瘤治疗系统,包括:
导管,其具有近端、远端、以及在近端和远端之间延伸的腔体;和
阻塞装置,其布置在腔体内,并且配置成放置到动脉瘤中以限制流体在动脉瘤内流动,所述阻塞装置包括:
远侧区段,其包括具有外径、线圈长度、以及线圈挠性的线圈;和
自身扩展的编织的近侧区段,其具有:(i)当定位在输送腔体内时具有第一直径的径向压缩状态;(ii)当未约束时具有大于线圈直径的第二直径的径向扩展状态;(iii)大于线圈长度的编织物长度,和(iv)在每单位长度上小于线圈挠性的编织物挠性;
其中,近侧区段被配置成在行进出导管的远端期间扩展,并且远侧区段被配置成沿线圈长度的至少一部分分配沿动脉瘤内壁的行进力。
款项2.根据款项1所述的系统,其中,线圈外径基本恒定。
款项3.根据款项1所述的系统,其中,远侧区段被配置成抵接动脉瘤内壁,以在近侧区段行进到动脉瘤中时引导最远的近侧区段。
款项4.根据款项1所述的系统,其中,当近侧区段在输送腔体中时,第一直径与线圈直径基本相同。
款项5.根据款项1所述的系统,其中,远侧区段包括弯曲的远端。
款项6.根据款项1所述的系统,其中,远侧区段的最大曲率半径小于近侧区段的最大曲率半径。
款项7.根据款项1所述的系统,其中,近侧区段在径向扩展状态下时具有二级的预设三维形状。
款项8.根据款项1所述的系统,其中,编织物长度从大约50mm到大约150mm。
款项9.根据款项1所述的系统,其中,线圈长度从大约30mm到大约40mm。
款项10.根据款项1所述的系统,其中,第二直径是第一直径的大约2.8倍到大约5.8倍,并且第一直径从大约0.017英寸和大约0.021英寸。
款项11.根据款项1所述的系统,其中,近侧区段包括在第一平面内的第一弯曲部分和在第一平面外的第二弯曲部分。
款项12.根据款项1所述的系统,其中,近侧区段的壁包括平均孔尺寸从大约25微米到大约250微米的孔。
款项13.根据款项1所述的系统,还包括在近侧区段内延伸并且连接到近侧区段的成形部件。
款项14.根据款项1所述的系统,还包括在近侧和远侧区段之间的过渡区段,所述过渡区段具有在每单位长度上比线圈挠性和编织物挠性更低的挠性。
款项15.一种阻塞装置,包括:
远侧区段,其包括具有外横截面尺寸、线圈长度、以及线圈挠性的线圈;和
自身扩展的编织的近侧区段,其具有:(i)当定位在输送腔体内时具有第一横截面尺寸的径向压缩状态;(ii)当未约束时具有大于线圈横截面尺寸的第二横截面尺寸的径向扩展状态;(iii)大于线圈长度的编织物长度;和(iv)在每单位长度上小于线圈挠性的编织物挠性;并且
其中,装置被配置成放置到动脉瘤中以限制流体在动脉瘤内流动。
款项16.根据款项15所述的装置,其中,编织物长度从大约50mm到大约150mm。
款项17.根据款项15所述的装置,其中,线圈长度从大约30mm到大约40mm。
款项18.根据款项15所述的装置,还包括在近侧和远侧区段之间的过渡区段,所述过渡区段具有在每单位长度上比线圈挠性和编织物挠性更低的挠性。
款项19.一种治疗动脉瘤的方法,所述方法包括:
将在血管内的导管邻近动脉瘤定位;
使阻塞装置的远侧区段从导管的远端行进,远侧区段包括具有线圈长度和线圈直径的线圈;
通过使近侧区段行进出导管的远端,将阻塞装置的近侧区段从当定位在输送腔体内时具有第一直径的径向压缩状态扩展成当未约束时具有大于线圈直径的第二直径的径向扩展状态;
其中,随着近侧区段行进出导管的远端,远侧区段沿线圈长度的至少一部分分配沿动脉瘤内壁的行进力。
款项20.根据款项19所述的方法,其中,近侧区段包括在每单位长度上大于远侧区段挠性的挠性。
款项21.根据款项19所述的方法,其中,使远侧区段行进包括使动脉瘤内壁与线圈的侧壁抵接。
款项22.根据款项19所述的方法,还包括使附加阻塞装置行进到动脉瘤中。
款项23.根据款项22所述的方法,其中,附加阻塞装置包括非扩展线圈或编织的装置中的至少一个。
款项24.根据款项22所述的方法,其中,附加阻塞装置包括小于近侧区段直径的直径。
款项25.根据款项22所述的方法,其中,近侧区段定位在动脉瘤内,以使得近侧区段的节段延伸跨过动脉瘤口,以阻止附加装置排出。
应该理解的是,前述总体说明和以下详细说明都是示例性和解释性的,并且旨在提供对于本技术主题的进一步说明。
附图说明
以下参考附图描述本发明的示意性实施例的各种特征。所示实施例旨在阐述但并非限制本发明。所述附图包含以下图:
图1示出根据一些实施例的在未约束构型下的阻塞装置。
图2A示出根据一些实施例的被推出导管的远端的图1的阻塞装置,其中末端线圈呈现未约束构型。
图2B示出根据一些实施例的被推出导管的远端的阻塞装置,其中末端线圈呈现未约束构型,编织物开始显现并且直径扩展。
图2C示出根据一些实施例的被推出导管的远端的阻塞装置,其中末端线圈呈现未约束构型并且编织物开始呈现直径扩展的三维未约束构型。
图2D示出根据一些实施例的从导管完全显现的阻塞装置,其中编织物处于直径扩展的三维未约束构型。
图3A示出根据一些实施例的被推出导管的远端并且进入动脉瘤的图1的阻塞装置,其中末端线圈呈现未约束或半约束构型。
图3B示出根据一些实施例的被推出导管的远端并且进入动脉瘤的阻塞装置,其中末端线圈呈现未约束或半约束构型,编织物开始显现并且直径扩展。
图3C示出根据一些实施例的被推出导管的远端并且进入动脉瘤的阻塞装置,其中末端线圈呈现未约束或半约束构型,编织物持续显现并且直径扩展。
图3D示出根据一些实施例的被推出导管的远端并且进入动脉瘤的阻塞装置,其中末端线圈呈现未约束或半约束构型,并且编织物开始呈现直径扩展的三维未约束构型。
图3E示出根据一些实施例的从导管的远端几乎完全展开并且进入动脉瘤的阻塞装置,其中末端线圈呈现未约束或未约束构型,并且编织物处于直径扩展的三维未约束构型。
图4描绘根据一些实施例的定位在动脉瘤中并缺少末端线圈的阻塞装置的实施例。
图5A、5B和5C是根据一些实施例的定位在动脉瘤中并具有编织物和末端线圈的阻塞装置的另一实施例的几个视图。
图6A、6B和6C是根据一些实施例的阻塞装置的另一实施例的几个视图,所述阻塞装置定位在动脉瘤中,具有编织物并且没有末端线圈。
图7是根据一些实施例的阻塞装置。
图8是根据一些实施例的另一阻塞装置。
具体实施方式
在以下详细说明中,为了提供对本技术主题的完全理解,列出许多具体细节。应该理解的是,本技术主题可以在没有这些具体细节中的一些的情况下实践。在其他情况下,没有详细示出完好的结构和技术以便不模糊本技术主题。
而且,虽然本说明书列出各种实施例的具体细节,应理解的是,说明仅是示意性并且不应该以任何方式被解释为限制性。此外,应该理解的是,虽然本发明的特定实施例可以以动脉瘤治疗的背景被公开或示出,但这些实施例可以被用于在脉管系统内的其他阻塞治疗中。此外,这些实施例和可能被本领域技术人员理解的修改方案的各种应用也被在此描述的总体概念所包含。
依据在此公开的一些实施例的一个方面,提供了阻塞装置及其使用方法,所述阻塞装置及其使用方法在阻塞动脉瘤方面比例如仅仅使用传统线圈更有优势。一些实施例可以提供比传统线圈更大的体积,这能够允许展开更少的装置材料同时倾向于提高被植入装置的促凝性。而且,一些实施例也可以更加容易地在动脉瘤囊或腔内操纵。例如,所述装置可以更加容易地符合动脉瘤腔的内部形状。此外,当动脉瘤开始尺寸减小时,一些实施例的方面允许所述装置变形,以使得所述装置可以在尺寸上被压缩或缩小,以促进治愈动脉瘤,这在使用传统线圈或其他装置的情况下通常是不可能的。
图1描绘了阻塞装置100的一个实施例,所述阻塞装置适用于阻塞体空间,诸如动脉瘤(包括神经血管动脉瘤或颅内动脉瘤)、或血管或其他中空解剖结构。所描述的阻塞装置100包括近侧区段102,所述近侧区段可以包括可扩展的、大致管状的编织物。近侧区段102可以是自身扩展的,以使得近侧区段倾向于在没有约束的情况下呈现其扩展状态。阻塞装置100还包括远侧区段104,所述远侧区段连接到近侧区段102的远端110。所描述的远侧区段104是远离近侧区段102的远端110延伸的无损伤末端线圈。其他合适的无损伤末端结构(例如,柔软的向远侧延伸的聚合物部件)可以代替所描述的末端线圈使用。
近侧区段102可以包括具有多条股线(诸如金属线材或聚合物细丝)的编织物,所述多条股线被编织在一起以形成管道,所述管道的侧壁由编织线材形成。腔体沿着近侧区段102在近侧区段102内延伸,并且被侧壁围绕。在图1中描述的近侧区段102中,近端和远端108、110都被闭合。然而,近端或远端108、110中的一个或两个可能是打开的。闭合端可通过卷边、焊接等等、以及其他紧固件或方法形成。
在图1中示出的阻塞装置100中,近侧区段102的编织物在其未约束状态下(或在其半约束状态下,诸如在动脉瘤内)呈现"三维"构型。这种三维构型的一个示例在图1中示出。这种构型是三维的,因为近侧区段102的中央轴线或纵向轴线并非基本平坦或基本在单一平面上。取代地,近侧区段102在大约居中于近侧区段102的纵向中点处形成第一弯曲或弯折部分200(参见图1和图2D)。该第一弯曲部分200的特征在于近侧区段102的一部分,在近侧区段的所述一部分中,近侧区段102的中央轴线基本位于第一平面内。在第一弯曲部分200的相反两端,近侧区段102的近端和远端部分可以弯折和伸出第一平面,以形成分别位于第一弯曲部分200的近侧和远侧的第二和第三弯折部分或弯曲部分202、204。第二和第三弯曲部分202、204可以沿大致相同方向远离第一弯曲部分200的平面延伸,或沿相反方向或以其它方式不同的方向延伸。
在图1和2D中示出的三维构型可以被认为是复合弯曲部分或多平面弯曲部分,所述复合弯曲部分或多平面弯曲部分是可能在近侧区段102中采用的一种类型的三维构型。球形三维构型可以通过将近侧区段102缠绕在球形心轴上并且热定型所述近侧区段102而实现。螺旋是可采用的另一类型的三维构型,其通过热定型近侧区段102同时将所述近侧区段缠绕在圆柱形心轴上而实施。
如前所述,近侧区段102可以包括可扩展的编织物,例如,自身可扩展的编织物,以使得近侧区段102在扩展时可以沿其长度的一些或全部呈现更大的直径。因此,当从约束释放时,诸如当被推出输送导管140的远端138时,近侧区段102可以呈现展开构型,在所述展开构型中,近侧区段102既直径扩展又呈现三维构型。
在近侧区段102包括可能在神经血管动脉瘤中有用的编织物的某些实施例中,编织物在其扩展状态下可以具有大约为1.5-2.5mm的直径。线圈或远侧区段104可以配置成具有基本恒定的外径,并且可以从大约0.20mm到大约3mm、从大约0.30mm到大约2.5mm、从大约0.50mm到大约2mm、或从大约0.40mm到大约1.5mm,并且在一些实施例中为大约0.45mm。
而且,在一些实施例中,当近侧区段在输送腔体中时,近侧区段102的缩小直径可以与线圈或远侧区段直径基本相同。缩小直径可以从大约0.014英寸到大约0.034英寸。缩小直径可以从大约0.016英寸到大约0.027英寸。在一些实施例中,缩小直径可以从大约0.017英寸到大约0.021英寸(这可以有助于输送穿过类似尺寸的导管)。扩展直径可以是缩小直径的大约2倍到大约8倍。扩展直径可以是缩小直径的大约2.4倍到大约7倍。而且,扩展直径可以是缩小直径的大约2.8倍到大约5.8倍。
然而,其他直径也在本公开的范围内。例如,编织物可以尺寸定为直径是动脉瘤的直径或最大宽度的大约三分之一到二分之一,阻塞装置100将被置放在所述动脉瘤中。这种编织物应该优选比待用于类似应用的小直径编织物更短。
而且,线圈或远侧区段长度可以从大约20mm到大约80mm。在一些实施例中,线圈长度可以从大约30mm到大约60mm。线圈长度也可以从大约35mm到大约50mm。而且,线圈长度可以是大约40mm。编织物可以具有当从其压缩长度扩展时缩短的能力(并且也具有当从其扩展形式压缩时伸长的能力)。
要在上述神经血管动脉瘤中使用的阻塞装置可以具有编织物或近侧区段,所述编织物或近侧区段当在扩展状态下大约长40-180mm。编织物或近侧长度可以从大约50mm到大约150mm。在一些实施例中,编织物长度可以从大约70mm到大约130mm。而且,编织物长度可以从大约90mm到大约100mm。在一些实施例中,编织物长度也可以是大约100mm。
近侧区段102可以配置成具有栓塞特性,以便妨碍在其中展开阻塞装置100的体空间(例如,动脉瘤)中的血液流动。(扩展的)近侧区段102的孔隙度和/或平均孔尺寸可以被选定为使得妨碍血液流动的程度足以使动脉瘤或其他体空间形成血栓。
在一些实施例中,为了使得妨碍血液流动的程度足以使动脉瘤或其他体空间形成血栓,孔可以具有小于或等于大约500微米的平均孔尺寸。孔可以具有小于或等于大约320微米的平均孔尺寸。孔可以具有从大约50微米到大约320微米的平均孔尺寸。孔可以具有大致恒定的孔尺寸。孔可以具有使用内切圆直径测量的平均孔尺寸。
例如,可以在扩展的近侧区段102中采用范围在10%-90%中的孔隙度和/或范围在25-250微米(内切圆直径)中的平均孔尺寸,以使得妨碍血液流动的程度足以使动脉瘤或其他体空间形成血栓。
如前所述,近侧区段102可以包括可以由金属线材或股线构造的编织物。合适的金属包括不锈钢(例如,304V不锈钢)、钴镍合金、钴铬或钴铬镍(例如,L605钴铬镍,35NLT钴铬镍,或MP35N钴铬镍)合金、镍钛诺、铂或铂钨合金。可以采用可生物降解的线材,其由镁或其合金、铁或铁合金、或聚合物(诸如PLA或PGA)形式形成。编织物可以由上述线材组合形成,例如将一组钴合金线材与一组铂钨线材编织。在一些实施例中,编织线材的直径可以是大约0.0010英寸、或直径的范围是0.0008到0.0020英寸。可以采用多种不同的编织模式,而且一种可能的模式采用编织成一上二下二布置(one-over-two-under-two arrangement)的32根股线,每英寸纬数为120。在一个实施例中,编织物完全由304V不锈钢股线构造。在另一实施例中,采用L605、镍钛诺和铂钨线材的组合。
编织线材可以是单丝、线缆、包覆线材或类似物。编织线材中的一种或多种可以包括海波管,所述海波管可以包括形成在其侧壁中的微孔。可吸收和/或形成栓塞的材料(包括任何在此讨论的材料)可以被定位在海波管的腔体中并且暴露成经由微孔与环境血液和解剖结构接触。
编织细丝材料中的一根或多根可以被选定为当暴露于磁共振成像时产生热量。例如,可以在编织物中采用铁或马氏体不锈钢线材。通过使用这种编织物,保持阻塞装置100的被治疗的体空间或动脉瘤可在植入后暴露于MRI。编织物响应于MRI产生热量,这继而促进在动脉瘤或体空间中形成血栓。
近侧区段102的腔体可以是空的或有空隙的,如所描述的实施例所示。这给近侧区段102提供很大自由度,以在使用期间扩展、收缩、变短或变长。可选地,材料可被定位在腔体中,所述材料诸如是形成血栓的纤维(例如,聚合物和/或可吸收纤维,诸如PLA或PGA纤维,它们可以被卷边或堆积)或金属元件(比如线圈或芯线材)。可以采用芯线圈,诸如铂线材,所述铂线材具有初级绕组并且大致沿近侧区段102的中央轴线从一端到另一端延伸。
远侧区段104可以包括柔软或无损伤末端线圈,所述柔软或无损伤末端线圈从近侧区段102的远端110大致向远侧延伸。例如,远侧区段104可以是挠性铂钨线圈,所述挠性铂钨线圈具有大致围绕阻塞装置100的纵向轴线定向的初级绕组。远侧区段104可以包括在其中纵向延伸以用作抗伸长装置的芯线材或类似物。远侧区段104可以在其未约束(或半约束)状态下具有二维构型,诸如在图1和2A-2D中示出的二维弯曲构型。可替换地,远侧区段104可以在未约束/半约束状态时具有三维构型。
当将阻塞装置100插入体空间(诸如动脉瘤)中时,远侧区段104可以当作用于阻塞装置100的挠性无损伤引入部分。如在图3A中看见的,随着装置从导管140传送到动脉瘤中,远侧区段104首先出现。由于相对柔软的远侧区段104,动脉瘤经历的损伤被最小化。远侧区段104开始呈现其弯曲的半约束构型(图3B),从而形成弯曲部分,所述弯曲部分的直径略小于动脉瘤的直径。展开的远侧区段104然后用作引导件,所述引导件防止即将到来的近侧区段102"迎面"撞击动脉瘤壁,从而与单一点或集中区域接触,如同可以利用锐利、尖锐、坚硬、和/或坚固的末端或接触点实现的那样。近侧区段102然后可以行进到动脉瘤中而不会不适当地伤害到动脉瘤壁。
利用阻塞装置100治疗动脉瘤300的方法的一个实施例的进行如下。首先,导管140(诸如微型导管)在载瘤血管内行进到动脉瘤300的位置或接近动脉瘤的位置。阻塞装置100在导管腔体内向远侧行进(例如,经由推送线材,所述推送线材可移除地连接到近侧区段102的近端108),远侧区段104引导近侧区段102,以使得远侧区段104从导管140的远端138出现并且首先进入动脉瘤300(图3A)。
随着远侧区段104进入动脉瘤300,所述远侧区段104可以被致使呈现其未约束或半约束构型,诸如在图3A-3B中示出的二维弯曲构型。近侧区段102然后行进出导管140的远端138并且进入动脉瘤300。随着近侧区段102在行进出导管140的远端138期间扩展,远侧区段104可以被配置成沿线圈长度的至少一部分分配沿动脉瘤内壁302的行进力。
近侧区段102因此可以被允许直径扩展(并且在一些实施例中也变短)并且呈现未约束或半约束构型,所述未约束或半约束构型可以是三维构型,诸如那些在此讨论的三维构型中的任何一个。当阻塞装置100在动脉瘤300中完全展开时,所述阻塞装置的扩展直径、三维构型妨碍在动脉瘤300中的血液流动,从而导致血栓。因此,阻塞装置100使动脉瘤300形成血栓并且将动脉瘤密封以不暴露于血液流动,从而减小或消除破裂和大出血的危险。
在这种方法的其他实施例中,动脉瘤300是破裂的、宽瘤颈的、大型或巨型的动脉瘤。在动脉瘤300是破裂的和/或具有宽瘤颈304的情况下,所述方法还包括通过允许或致使近侧区段102直径扩展和/或呈现三维构型而防止阻塞装置100穿过破裂部位或瘤颈304。
所述方法还可以包括采用展开的阻塞装置100作为框架或填充装置,并且将附加阻塞装置输送到动脉瘤300中,所述附加阻塞装置可以具有在此描述的扩展编织物类型的近侧区段、或标准的非扩展线圈。所述装置100可以跨过瘤颈304,以防止自身形成疝,并且如果其他装置也被植入动脉瘤中,也防止其他装置形成疝。
此外,阻塞装置可以有利地提供多个交点和比其他装置更大的跨过瘤颈304的装置表面区域。如在图5C和6C中大致所示,当装置304在动脉瘤300内扩展时,近侧区段102可以与自身和远侧区段104重叠,以形成多个交点和比可能按其它方式使用的传统线圈、网篮、或其他装置更少且更小的间隙。此外,因为近侧部分102包括比传统线圈的腔体尺寸更大的内部体积或腔体,同时比动脉瘤300的直径小得多,所以在动脉瘤300内并且遍及瘤颈304地重叠和翻转近侧部分102可以形成被偏流层分开的明显更小的凹穴或体积,所述偏流层可以以比传统线圈、网篮、或其他装置明显更快的速率促进凝固,以及比传统线圈、网篮、或其他装置更加促进遍及瘤颈304的内皮化。
所述方法还可以包括通过允许或致使近侧区段102直径扩展和/或呈现三维构型而防止阻塞装置100穿过动脉瘤瘤颈304。
在采用推送线材的情况下,推送线材可以包括远侧钩,所述远侧钩环绕穿过在阻塞装置100的近端处形成的眼孔。可以采用其他附接部件,包括那些具有医学或电解拆卸能力的附接部件。作为传输方式的替代方案,阻塞装置100可以被载入输送鞘的腔体的远侧部分,所述输送鞘继而可以被配置成通过更大的导管输送到治疗部位。具有预加载的阻塞装置100的输送鞘穿过导管140行进到治疗部位,并且阻塞装置100可以经由推送线材或推送杆从输送鞘的远端展开。
如图7所示,在阻塞装置100的其他实施例中,内部部件350可以被布置在近侧区段102的腔体中,沿腔体大致纵向地延伸。内部部件350可以选择性地从近侧区段102的近端108延伸到其远端110。如图7所示,内部部件350可以选择性地包括成形部件,在此将更加详细地讨论成形部件的各种实施例。成形部件350(或内部部件的其他形式)可以包括细长单丝或复丝,所述单丝诸如是单一股线的金属线材或聚合物细丝,所述复丝诸如是由单一或多种材料的线材和/或细丝扭在一起形成的线缆、或细长编织物或织网结构、或利用卡箍或其他合适的捆扎结构保持在一起的多根大致平行的细丝的束。
可以在近侧区段102的腔体中采用成形部件350,以当成形部件组件352(例如,近侧区段102)在其未约束状态下时,赋予近侧区段102二维或三维构型。可以采用成形部件350以赋予在此讨论的任何二维或三维构型、或其他合适的所述构型。期望的未约束构型可以被热定型或以其它方式加工到成形部件350中。可以采用成形部件350,其中近侧区段自身不具有特定的热定型的或以其它方式预设的未约束构型,或近侧区段具有二维或三维未约束构型。在仅成形部件350具有预设的未约束构型的情况下,成形部件350可以促使近侧区段在从输送导管140释放或进入动脉瘤300时成为二维或三维未约束或半约束构型。这样通过近侧区段102实现的未约束构型可以大致类似于在成形部件350中预设的未约束构型。
作为如上讨论的二维或三维构型的代替或补充方案,内部部件或成形部件350可以是大致螺旋状的,其中,成形部件350大致围绕近侧区段102的中央轴线盘绕,并且成形部件350的径向外表面抵接或靠近近侧区段102的内表面。这种成形部件350可以被配置成在近侧区段102的腔体内自身扩展到更大直径的构型,由此当作用于近侧区段102的扩展协助,从而当成形部件的组件352例如从输送导管140内的约束释放时,所述成形部件的组件倾向于促使近侧区段102朝向更大直径的构型打开。
当成形部件的组件352诸如在输送导管140的腔体内被径向压缩时,这种成形部件350也可以呈现直径减小和/或基本笔直的构型。这可以被当作近侧区段102或成形部件的组件352的输送构型。在这种输送构型中,直径减小和/或基本笔直的成形部件350可以通过赋予近侧区段102柱状强度而用作输送协助。在采用这种螺旋状成形部件的情况下,成形部件的近端和远端可以被分别牢固地连接到近侧区段102的近端和远端108、110,并且近侧区段102和成形部件的纵向收缩/伸长特性可以被匹配,以使得扩展或收缩近侧区段102或成形部件中的其中一个不会倾向于使另一个延伸过长或变形。
在另一实施中,可以采用大致螺旋状的内部部件或成形部件,并且所述内部部件或成形部件如上讨论地连接到近侧区段102的两端108、110。然而,内部部件350可以被配置成在被径向约束时比近侧区段102以略高的速率拉长,以使得将成形部件的组件插入输送导管140腔体使得成形部件拉长,这继而迫使近侧区段102变成细长的径向收缩构型,该径向收缩构型比在没有成形部件的作用力的情况下更加细长和径向收缩。成形部件因此在输送期间将近侧区段102保持在径向收缩的状态。这减小了近侧区段102和导管140之间的摩擦,并且使得阻塞装置100的输送更加容易。
作为在此讨论的拉长的代替或补充方案,近侧区段102可以被预先扭转以提供用于输送的更小轮廓。
在采用相对高的柱状强度的内部部件或成形部件350,并且成形部件350的远端或一部分被牢固地连接到近侧区段102的远端110或一部分的情况下,成形部件350可以通过将指向远侧的纵向力施加到近侧区段102的远端110或一部分而被用于促使近侧区段102成为直径减小构型。这可以例如在成形部件的组件352定位在输送导管140的腔体中时通过沿远侧方向手动推送内部部件或成形部件350的近侧延伸部分而实现。这继而使近侧区段102拉长,同时减小近侧区段在导管140内的直径,从而易于使近侧区段102穿过导管140。
内部部件或成形部件350可以包括一根或多根如上讨论地预先成形的镍钛诺线材。一种合适形式的镍钛诺是马氏体镍钛诺,所述马氏体镍钛诺可以被用于提供相对内部部件或成形部件350。此外,可以采用镍钛诺或马氏体镍钛诺(或其他材料)的成形部件,所述成形部件在处于或接近室内温度时基本笔直(并且相对细长),并且在处于或接近人体温度时绕圈(并且相对变短)。这种成形部件可以如上讨论地被用于在输送穿过导管腔体期间以径向收缩状态保持近侧区段102。
内部部件或成形部件350可以包括线材、线缆、编织物或类似物,其中一个或多个相对柔软的(例如,聚合物或弹性体)衬垫安装在所述线材、线缆、编织物或类似物上。因此,当阻塞装置100的近侧区段102在导管140的腔体内时,内部部件350将呈现相对笔直的纵向定向的构型,并且近侧区段102将呈现径向压缩的构型,其中近侧区段的内壁与一个或多个衬垫接触。近侧区段102因此被夹持在衬垫(衬垫尺寸定为有助于这种夹持)和导管140的内壁之间,并且内部部件350因此被配置成用作柱状或纵向力传递部件,以使得通过例如在近侧区段102的近端108处将指向远侧的力施加到阻塞装置100而可以在输送期间沿导管腔体向远侧推送阻塞装置100。远侧力沿内部部件350传递到衬垫,并且从衬垫传递到向远侧行进的近侧区段102。导管140的内壁有助于在近侧区段102和衬垫之间形成充足的摩擦,以使得力能够从衬垫传递到近侧区段102。在内部部件或成形部件350上采用这种类型的衬垫的情况下,内部部件350可以被配置成在未约束或半约束时绕圈成螺旋、或呈现某种其他的二维或三维形状,并且由此引起衬垫与近侧区段102的内壁脱离接触。
如图8所示,装置100也可以在近侧和远侧区段102、104之间包括至少一个过渡区段400。过渡区段400可以具有在每单位长度上比线圈挠性和编织物挠性更低的挠性。
在为近侧、过渡、或远侧区段中的任何一个测量挠性时,所述挠性可以被确定为以下测量值:每单位长度的抗弯强度、在全部长度上的抗弯强度、区段每单位长度的抗屈强度、或区段总长度的抗屈强度。例如,可以使用传统公式计算抗弯强度:σ=(3PL)/(2wt2),其中P是法向力,L是束的长度,w是束的宽度,t是束的厚度,并且y是加载点的挠曲。而且,可以通过使用不同样本和图表计算区段的大致抗屈强度而根据经验确定抗屈强度,包括使用传统公式:σ=E*ε。
过渡区段400也可以包括将近侧和远侧区段102、104互连的管状或实心部件。过渡区段400可以包括一个或多个渐缩部件。在一些实施例中,装置100可以在近侧和远侧区段102、104之间包括多个过渡区段。
在一些实施例中,过渡区段400可以限定长度大于或等于远侧区段104的长度。而且,近侧区段102的长度也可以大于或等于远侧区段104的长度。因此,在数学关系中,远侧区段104与过渡区域400以及近侧区段102的长度的比例可以被表述为:1:≥1:≥1。
因此,过渡区域400可以限定长度大于远侧区段104的长度。而且,过渡长度可以从大约30mm到大约120mm。在一些实施例中,过渡长度可以从大约40mm到大约100mm。过渡长度也可以从大约50mm到大约80mm。而且,过渡长度可以是大约60mm。
在植入之前,阻塞装置100可以被冷却,例如被低温冷却。当输送到被治疗的动脉瘤或体空间中时,阻塞装置100的低温将促进在动脉瘤或体空间中形成血栓。作为这种预先冷却的代替或补充方案,阻塞装置100的近侧区段102或其他部分可以被涂覆或粘附有与血液或其他体液或物质吸热地反应的物质。当输送到被治疗的动脉瘤或体空间中时,反应物质将吸热地反应并且使邻近的血液或其他解剖结构降温,由此促进在动脉瘤或体空间中形成血栓。作为上述冷却方法的代替或补充方案,可以提供海波管,所述海波管从阻塞装置100向患者近侧延伸出来,并且被用于将冷却剂(诸如冷却盐水)传输到被植入的阻塞装置100,以使装置和/或周围解剖结构降温并且促进血栓形成。这种海波管可以可替换地或补充地被用于将其他材料传输到被植入的阻塞装置100(例如,传递到编织物腔体中),所述其他材料包括栓塞材料,诸如微型球体或栓塞液体。
作为所公开的近侧区段102的代替方案,对于阻塞装置100的近侧区段102可以采用织网管状结构。作为另一替代方案,近侧区段102可以包括代替编织物或织网管的激光切割或光刻蚀的支架、或由一根或多根非织纤维形成的管道,例如,被挤压或以其它方式结合在一起形成管状或片状材料的长纤维。作为又一替代方案,合适长度和直径的高度兼容的球囊可以被用作近侧区段102,并且所述球囊在输送到正在被治疗的动脉瘤或体空间中之后由盐水或其他合适的流体充胀。
被用作近侧区段102的编织物、织物、支架等等可以被管状聚合物膜沿近侧区段长度的一些或全部被覆盖。膜可以具有形成在其中的孔,以便向血液流动赋予期望水平的促凝性和/或阻力。作为这种膜的代替或补充方案,在阻塞装置100或近侧区段102中可以采用形成血栓的材料作为涂层、添加剂或其他,所述形成血栓的材料例如是金、铂、铂铱合金、或纤维蛋白。在采用编织物的情况下,编织线材金属可被选定为使得由不同金属的线材之间的交点处的电相互作用引起的电流(以及任何产生的促凝性)最大化。
虽然这些发明的实施例已经在某些实施例的内容中公开,但是本领域技术人员理解的是,本发明除了具体公开的实施例之外还延及到其他替代性实施例和/或本发明的用途、以及它们的明显修改和等同方案。此外,虽然已经详细示出和描述了本发明的几个变型方案,但是对本领域技术人员而言,基于本公开内容,在本发明范围内的其他修改方案将变得显而易见。也可以构思到的是,可以对实施例的具体特征和方面做出各种组合和子组合并且仍然落入本发明的范围内。应该理解的是,所公开的实施例的各种特征和方面可以相互组合或替换,以形成所公开的发明的变化模式。

Claims (18)

1.一种动脉瘤治疗系统,包括以下部件的组合:
导管,该导管具有近端、远端、以及在近端和远端之间延伸的腔体;和
阻塞装置,该阻塞装置布置在腔体内,并且配置成放置到动脉瘤中以限制在动脉瘤内的流体流动,所述阻塞装置包括:
远侧区段,该远侧区段包括具有线圈近端、外径、线圈长度、以及线圈挠性的线圈;和
自身扩展的编织的近侧区段,该近侧区段具有连接到线圈近端的编织物远端和空腔,在所述空腔中无材料,所述近侧区段具有:(i)当定位在输送腔体内时具有第一直径的径向压缩状态;(ii)当未约束时具有大于线圈直径的第二直径的径向扩展状态;(iii)大于线圈长度的编织物长度;和(iv)在每单位长度上小于线圈挠性的编织物挠性;
其中,近侧区段被配置成在行进到导管的远端外的期间扩展,并且远侧区段被配置成沿线圈长度的至少一部分分配沿动脉瘤内壁的行进力。
2.根据权利要求1所述的动脉瘤治疗系统,其中,线圈外径恒定。
3.根据权利要求1所述的动脉瘤治疗系统,其中,远侧区段被配置成抵接动脉瘤内壁,以在近侧区段行进到动脉瘤中时引导最远的近侧区段。
4.根据权利要求1所述的动脉瘤治疗系统,其中,当近侧区段在输送腔体中时,第一直径与线圈直径相同。
5.根据权利要求1所述的动脉瘤治疗系统,其中,远侧区段包括弯曲的远端。
6.根据权利要求1所述的动脉瘤治疗系统,其中,远侧区段的最大曲率半径小于近侧区段的最大曲率半径。
7.根据权利要求1所述的动脉瘤治疗系统,其中,近侧区段在径向扩展状态下时具有二级的预设三维形状。
8.根据权利要求1所述的动脉瘤治疗系统,其中,编织物长度为从50mm到150mm。
9.根据权利要求1所述的动脉瘤治疗系统,其中,线圈长度为从30mm到40mm。
10.根据权利要求1所述的动脉瘤治疗系统,其中,第二直径是第一直径的2.8倍到5.8倍,并且第一直径从0.017英寸到0.021英寸。
11.根据权利要求1所述的动脉瘤治疗系统,其中,近侧区段包括在第一平面内的第一弯曲部分和在第一平面外的第二弯曲部分。
12.根据权利要求1所述的动脉瘤治疗系统,其中,近侧区段的壁包括平均孔尺寸从25微米到250微米的孔。
13.根据权利要求1所述的动脉瘤治疗系统,还包括在近侧区段内延伸并且连接到近侧区段的成形部件。
14.根据权利要求1所述的动脉瘤治疗系统,还包括在近侧区段和远侧区段之间的过渡区段,所述过渡区段具有在每单位长度上比线圈挠性和编织物挠性更低的挠性。
15.一种阻塞装置,包括:
远侧区段,该远侧区段包括具有线圈近端、外横截面尺寸、线圈长度、以及线圈挠性的线圈;和
自身扩展的编织的近侧区段,该近侧区段具有连接到线圈近端的编织物远端和空腔,在所述空腔中无材料,所述近侧区段具有:(i)当定位在输送腔体内时具有第一横截面尺寸的径向压缩状态;(ii)当未约束时具有大于线圈横截面尺寸的第二横截面尺寸的径向扩展状态;(iii)大于线圈长度的编织物长度;和(iv)在每单位长度上小于线圈挠性的编织物挠性;并且
其中,所述阻塞装置被配置成放置到动脉瘤中以限制在动脉瘤内的流体流动。
16.根据权利要求15所述的装置,其中,编织物长度为从50mm到150mm。
17.根据权利要求15所述的装置,其中,线圈长度为从30mm到40mm。
18.根据权利要求15所述的装置,还包括在近侧区段和远侧区段之间的过渡区段,所述过渡区段具有在每单位长度上比线圈挠性和编织物挠性更低的挠性。
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WO2013142756A1 (en) 2013-09-26
US20130253572A1 (en) 2013-09-26

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