CN113499176A - 用于医疗装置递送系统的联接单元 - Google Patents

用于医疗装置递送系统的联接单元 Download PDF

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CN113499176A
CN113499176A CN202110775400.XA CN202110775400A CN113499176A CN 113499176 A CN113499176 A CN 113499176A CN 202110775400 A CN202110775400 A CN 202110775400A CN 113499176 A CN113499176 A CN 113499176A
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distal
stent
proximal
delivery system
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CN113499176B (zh
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A·内格斯瓦兰
C·党
A·巴雷特
J·范
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Covidien LP
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents 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
    • 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
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/9522Means for mounting a stent or stent-graft onto or into a placement instrument
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • AHUMAN NECESSITIES
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    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A61F2/9662Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod the middle portion of the stent or stent-graft is released first
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/823Stents, different from stent-grafts, adapted to cover an aneurysm
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2002/9505Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A61F2002/9665Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod with additional retaining means
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    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0069Three-dimensional shapes cylindrical

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Abstract

公开了一种用于医疗装置递送系统的支架联接件。一种支架递送系统包括具有远侧段的芯构件和围绕所述芯构件远侧段定位的联接件。所述联接件能旋转地联接至所述芯构件并且包括刚性板,所述刚性板具有第一端面、第二端面以及在所述第一端面与所述第二端面之间延伸的侧表面,所述侧表面包括由凹陷部分开的一个或多个突出部。所述递送系统还包括支架,所述支架沿所述芯构件远侧段延伸,使得所述支架的内表面由所述接合构件的所述一个或多个突出部接合。

Description

用于医疗装置递送系统的联接单元
本申请是发明名称为“用于医疗装置递送系统的联接单元”、国际申请日为2018年1月19日、国际申请号为PCT/US2018/014510、国家申请号为201880007614.9的发明专利申请的分案申请。
相关申请的交叉引用
本申请要求2017年1月19日提交的美国申请第15/410,444号的优先权,所述申请全文以引用方式并入本文。
背景技术
脉管系统的壁,特别是动脉壁,可形成称为动脉瘤的病理性扩张区域,所述区域常常具有易于破裂的薄、弱壁。动脉瘤大体是由于疾病、损伤或先天性畸形所导致的血管壁弱化而引起的。动脉瘤出现在身体的不同部位,并且最常见的是腹主动脉瘤和神经血管系统中的脑(例如,大脑)动脉瘤。当动脉瘤的弱化壁破裂时,尤其是当脑动脉瘤壁破裂时,可能导致死亡。
动脉瘤通常通过将血管的弱化部分从动脉循环排除或至少部分地使其与动脉循环隔离来治疗。例如,常规的动脉瘤治疗包括:(i)外科夹紧术,其中将金属夹固定在动脉瘤的基部周围;(ii)利用小的柔性丝线圈(微线圈)捆扎动脉瘤;(iii)使用栓塞材料“填充”动脉瘤;(iv)使用可拆卸的球囊或线圈闭塞供应动脉瘤的载瘤血管;以及(v)血管内支架术。
血管内支架在治疗血管狭窄或动脉瘤的医学领域中是众所周知的。支架是在血管或腔内径向或以其他方式扩展来支撑血管以免塌缩的假体。用于递送这些血管内支架的方法也是众所周知的。
将压缩支架引入血管中并将其定位在狭窄区域或动脉瘤内的常规方法包括:将引导导管的远侧部分经皮推进穿过患者的血管系统,直到远侧部分接近狭窄或动脉瘤为止。将第二内导管和内导管内的导丝推进穿过引导导管的远侧区域。然后将导丝从引导导管的远侧区域推出至血管中,直到将承载压缩支架的导丝的远侧部分定位在血管内的病变点处为止。然后释放压缩支架并让其扩展,使得它在病变点处支撑血管。
发明内容
本技术例如根据下面描述的各个方面示出。为方便起见,将本技术的方面的各个示例作为编号条款(1、2、3等)进行描述。这些是作为示例提供的并且不限制本技术。应当注意,可将任何从属条款组合成任何组合,并放入相应的独立条款(例如,条款1或条款23)中。其他条款可以类似的方式呈现。
1.一种支架递送系统,其包括:
芯构件,所述芯构件具有远侧段;
联接件,所述联接件围绕所述芯构件远侧段定位并且能旋转地联接至所述芯构件,所述联接件包括刚性板,所述刚性板具有第一端面、第二端面以及在所述第一端面与所述第二端面之间延伸的侧表面,所述侧表面包括由凹陷部分开的一个或多个突出部;以及
支架,所述支架沿所述芯构件远侧段延伸,使得所述支架的内表面由所述联接件的所述一个或多个突出部接合。
2.如条款1所述的支架递送系统,其中所述突出部包括倒圆边缘。
3.如条款1所述的支架递送系统,其中所述一个或多个突出部包括三个或更多个突出部。
4.如条款1所述的支架递送系统,其中所述第一端面和所述第二端面的最长尺寸被配置以配合在0.017"、0.021"或0.027"内径的导管内。
5.如条款1所述的支架递送系统,其中所述第一端面和所述第二端面的最大长度是所述侧表面的长度的至少5倍大,所述第一端面和所述第二端面的所述最大长度与所述侧表面的所述长度大体上正交。
6.如条款1所述的支架递送系统,其中所述刚性板包括金属或刚性聚合物中的至少一种。
7.如条款1所述的支架递送系统,其中所述刚性板侧表面具有在约25微米-100微米之间的长度。
8.如条款1所述的支架递送系统,其中所述刚性板是第一刚性板,所述支架递送系统还包括:
第二刚性板,所述第二刚性板围绕所述芯构件远侧段定位并与所述第一刚性板间隔开;以及
间隔件,所述间隔件围绕所述芯构件远侧段定位,所述间隔件定位在所述第一刚性板与所述第二刚性板之间。
9.如条款8所述的支架递送系统,其中所述间隔件包括具有与所述芯构件的长轴正交的端壁的圆柱形主体。
10.如条款8所述的支架递送系统,其中所述第一刚性板和所述第二刚性板彼此间隔开的距离对应于所述支架的孔隙间距。
11.如条款1所述的支架递送系统,其中所述第一端面和所述第二端面与所述芯构件的长轴基本上正交。
12.如条款1所述的支架递送系统,其中所述突出部与所述支架互锁,使得每个突出部至少部分地被接收在所述支架的孔隙内。
13.一种支架递送系统,其包括:
导管,所述导管具有腔和沿所述腔延伸的内表面;
芯构件,所述芯构件在所述导管腔内延伸;
板,所述板包括:
第一端面、第二端面以及在所述第一端面与所述第二端面之间延伸的侧表面;以及
孔口,所述孔口穿过所述第一端面和所述第二端面延伸,所述芯构件延伸穿过所述孔口,使得所述板能围绕所述芯构件旋转;以及
支架,所述支架沿所述芯构件并且在所述板之上延伸,所述支架的至少一部分径向地定位在所述板侧表面与所述导管内表面之间。
14.如条款13所述的支架递送系统,其中所述板侧表面包括由凹陷部分开的多个突出部。
15.如条款14所述的支架递送系统,其中所述突出部与所述支架互锁,使得每个突出部至少部分地被接收在所述支架的孔隙内。
16.如条款14所述的支架递送系统,其中所述一个或多个突出部包括三个或更多个突出部。
17.如条款13所述的支架递送系统,其中所述第一端面和所述第二端面的最大长度是所述侧表面的长度的至少5倍大,所述第一端面和所述第二端面的所述最大长度与所述侧表面的所述长度大体上正交。
18.如条款13所述的支架递送系统,其中所述板包括金属或刚性聚合物中的至少一种。
19.如条款13所述的支架递送系统,其中所述板是第一板,所述支架递送系统还包括:
第二板,所述第二板围绕所述芯构件定位并且与所述第一板间隔开;以及
间隔件,所述间隔件围绕所述芯构件定位并且定位在所述第一板与所述第二板之间。
20.如条款19所述的支架递送系统,其中所述间隔件包括具有与所述芯构件的长轴正交的端壁的圆柱形主体。
21.如条款19所述的支架递送系统,其中所述第一板和所述第二板彼此间隔开的距离对应于所述支架的孔隙间距。
22.一种芯组件,其包括:
芯构件;
第一刚性板,所述第一刚性板围绕所述芯构件;
第二刚性板,所述第二刚性板围绕所述芯构件并与所述第一刚性板间隔开;以及
间隔件,所述间隔件围绕所述芯构件,所述间隔件设置在所述第一刚性板与所述第二刚性板之间。
23.如条款22所述的芯构件,其中所述第一刚性板和所述第二刚性板各自包括:
第一端面;
第二端面,所述第二端面与所述第一端面相反;
侧表面,所述侧表面在所述第一端面与所述第二端面之间延伸并且包括由凹陷部分开的多个突出部;以及
孔口,所述孔口穿过所述第一端面和所述第二端面延伸,所述孔口穿过其接收所述芯构件。
24.如条款23所述的芯构件,其中所述一个或多个突出部包括三个或更多个突出部。
25.如条款23所述的芯构件,其中所述第一端面和所述第二端面的最大长度是所述侧表面的长度的至少5倍大,所述第一端面和所述第二端面的所述最大长度与所述侧表面的所述长度大体上正交。
26.如条款23所述的芯构件,其中所述第一端面和所述第二端面与所述芯构件的长轴基本上正交。
27.如条款22所述的芯构件,其中所述第一刚性板和所述第二刚性板包括金属或刚性聚合物中的至少一种。
28.如条款22所述的芯构件,其中所述第一刚性板和所述第二刚性板各自具有在约25微米-100微米之间的厚度。
29.如条款22所述的芯构件,其中所述间隔件包括具有与所述芯构件的长轴正交的端壁的圆柱形主体。
30.一种用于接合支架的刚性板,所述板包括:
第一端面和第二端面;
侧表面,所述侧表面在所述第一端面与所述第二端面之间延伸并且包括由凹陷部分开的多个突出部;以及
中央开口,所述中央开口穿过所述刚性板在所述第一端面与所述第二端面之间延伸。
31.如条款30所述的刚性板,其中所述突出部包括倒圆边缘。
32.如条款30所述的刚性板,其中所述一个或多个突出部包括三个或更多个突出部。
33.如条款30所述的刚性板,其中所述第一端面和所述第二端面的最长尺寸被配置以配合在0.017"、0.021"或0.027"内径的导管内。
34.如条款30所述的刚性板,其中所述第一端面和所述第二端面的最大长度是所述侧表面的长度的至少5倍大,所述第一端面和所述第二端面的所述最大长度与所述侧表面的所述长度大体上正交。
35.如条款30所述的刚性板,其中所述刚性板包括金属或刚性聚合物中的至少一种。
36.如条款30所述的刚性板,其中所述侧表面具有在约25微米-100微米之间的长度。
37.如条款30所述的刚性板,其中所述第一端面和所述第二端面与所述中心开口的长轴基本上正交。
本技术的另外特征和优点将在以下描述中阐述,并且将部分地通过描述显而易见,或者可通过实践本主题技术来领会。本技术的优点将通过在书面描述及其权利要求以及附图中所特别指出的结构来实现并达到。
应当理解,上文的一般描述与下文的详细描述均是示例性和解释性的,并且意图对所申请保护的本技术提供进一步解释。
附图说明
可参考以下附图更好地理解本公开的许多方面。附图中的部件未必按比例绘制。相反,重点在于清楚地示出本技术的原理。为了易于参考,在整个本公开中,相同的参考标号可用于标识相同或至少大体上类似或相似的部件或特征。
图1是根据一些实施方案配置的医疗装置递送系统的示意图。
图2是根据一些实施方案的设置在体腔内的医疗装置递送系统的侧面剖视图。
图3是根据一些实施方案的图2中所示的医疗装置递送系统的芯组件的侧面剖视图。
图4是图2中所示的递送系统的放大侧面剖视图。
图5A是根据一些实施方案的具有联接件的联接单元的放大透视图。
图5B是上覆有支架的图5A的联接单元的放大透视图。
图6A至图6C分别是图5A和图5B的联接单元的单独联接件的侧视图、端视图和透视图。
图7是图5B的联接件和支架的示意性剖视图。
具体实施方式
常规的支架联接件包括依赖于摩擦配合来将支架(诸如编织、针织或织造支架)抵靠导管的内壁进行固定的柔软的“垫”。这类摩擦配合垫可能需要若干不同的垫直径以适应不同支架丝大小的混合。即,在给定导管大小内,容纳在导管中的压缩(编织、针织或织造)支架的内径将基于丝的大小(直径)、以及可能地支架的对应于不同的展开大小或目标血管大小的其他参数而变化。这可能需要使用不同的垫直径来在期望范围内(例如,约3.5毫米至5毫米的直径)适应不同的支架大小,这使得必须在非常小的大小公差下织造各种直径的垫。本技术的实施方案可允许单个大小的联接件在给定导管大小(例如,0.027"、0.021"或0.017"内径导管)内与相对宽泛范围的支架内径一起使用。例如,包括具有由凹陷部分开的多个突出部的刚性板的耦合器可用于在给定导管内固定一定范围的不同支架大小。
本文参考图1至图7描述本技术的若干实施方案的具体细节。尽管相对于用于递送支架和其他医疗装置的装置、系统和方法描述了许多实施方案,但是除了本文描述的那些之外的其他应用和其他实施方案也在本技术的范围内。应当指出的是,除了本文公开的实施方案之外的其他实施方案也在本技术的范围内。另外,本技术的实施方案可具有与本文所示出或描述的那些不同的配置、部件和/或过程。此外,本技术的实施方案可具有除了本文所示出或描述的那些之外的配置、部件和/或过程,并且在不偏离本技术的情况下,这些和其他实施方案可能不具有本文所示出或描述的若干配置、部件和/或过程。
如本文所用,术语“远侧”和“近侧”限定相对于临床医生或临床医生的控制装置(例如,递送导管的手柄)的位置或方向。例如,术语“远侧”和“朝远侧”是指沿装置的长度远离临床医生或临床医生的控制装置或在背离临床医生或临床医生的控制装置的方向上的位置。在相关实例中,术语“近侧”和“朝近侧”是指沿装置的长度靠近临床医生或临床医生的控制装置或在朝向临床医生或临床医生的控制装置的方向上的位置。本文提供的标题仅仅是为了方便,而不应当被视为限制所公开的主题。
用于医疗装置递送系统的联接件的选定实例
图1至图7描绘可用于将医疗装置(诸如但不限于支架)递送至中空解剖结构(诸如血管)中和/或使其展开的医疗装置递送系统的实施方案。所述支架可包括编织支架或其他形式的支架,诸如织造支架、针织支架、激光切割支架、卷式支架等。所述支架可任选地被配置来充当用于治疗动脉瘤(诸如在血管发现的那些动脉瘤,血管包括大脑中或颅内的动脉,或体内的其他位置中的动脉,诸如外周动脉)的“偏流器”装置。支架可任选地类似于由Medtronic Neurovascular of Irvine,California USA销售的任何版本或大小的PIPELINETM栓塞装置。支架可替代地可包括任何合适的管状医疗装置和/或其他特征,如本文所描述。
图1是根据本技术的实施方案配置的医疗装置递送系统100的示意图。系统100可包括可滑动地接收芯构件103的长形管或导管101,芯构件103被配置来携载支架105穿过导管101。所描绘的导管101具有近侧区域107和相反的远侧区域109、从近侧区域107延伸至远侧区域109的内腔111以及限定腔111的内表面113,远侧区域109可定位在患者体内的治疗部位。在远侧区域109处,导管101具有远侧开口115,芯构件103可穿过远侧开口115推进越过远侧区域109,以使支架105在血管116内扩展或展开。近侧区域107可包括导管毂(未示出)。导管101可限定在近侧区域107与远侧区域109之间延伸的大体上纵向尺寸。当递送系统100在使用中时,纵向尺寸不需要沿其一部分或任何长度是笔直的。
芯构件103被配置成大体上纵向延伸穿过导管101的腔111。芯构件103大体上可包括柔性和柱强度足以将支架105或其他医疗装置移动穿过导管101的任何一个或多个构件。芯构件103因此可包括丝、管(例如,海波管)、编织件、线圈或其他一种或多种合适的构件,或一根或多根丝、一根或多根管、一个或多个编织件、一个或多个线圈等的组合。
系统100还可包括联接单元117(例如,装置接口),所述联接单元117被配置来相对于芯构件103可释放地保持医疗装置或支架105。联接单元117被配置来下伏于支架105的内壁并接合内壁。以这种方式,联接单元117与导管101的上覆内表面113相配合以夹持支架105,使得联接单元117可沿导管101并在导管101内移动支架105,例如芯构件103相对于导管101的远侧和/或近侧移动导致支架105在导管腔111内的对应的远侧和/或近侧移动。
在一些实施方案中,联接单元117可被配置来围绕芯构件103旋转。在一些这样的实施方案中,联接单元117可包括近侧约束件119和远侧约束件121。近侧约束件119和远侧约束件121可固定至芯构件103以防止或限制联接单元117沿芯构件103的纵向尺寸的近侧或远侧移动。近侧约束件119和远侧约束件121中的一者或两者可具有小于联接单元117的外径或其他径向最外侧尺寸的外径或其他径向最外侧尺寸,使得约束件119、121中的一者或两者不接触支架105的内表面。
联接单元117还可包括一个或多个联接件123a-123c(例如,支架接合构件),所述一个或多个联接件123a-123c围绕芯构件103设置并且设置在近侧约束件119和远侧约束件121以及一个或多个间隔件125a-125d之间。在示出的实施方案中,联接件123a-123c通过间隔件125b-125c与彼此间隔开,联接件123a通过间隔件125a与近侧约束件119间隔开,并且联接件123c通过间隔件125d(在联接单元117的一些实施方案中可省略)与远侧约束件间隔开。联接件123a-123c中的一个、一些或全部可以是具有中心孔口的刚性板,所述中心孔口被配置来穿过其接收芯构件103。联接件123a-123c被配置来机械地接合支架105,使得联接件123a-123c保持支架105免于相对于芯构件103纵向移动。间隔件125a-125d各自可以是具有孔口的基本上圆柱形的主体,所述孔口被配置来穿过其接收芯构件103。间隔件125a-125d中的一个或全部可具有小于联接件123a-123c的外径或其他径向最外侧尺寸的外径或其他径向最外侧尺寸,这样间隔件125a-125d就不接触支架105的内表面。
尽管图1中示出的实施方案包括三个联接件123a-123c和四个间隔件125a-125d,但是联接件和间隔件的数量可以是变化的。在至少一个实施方案中,联接单元117包括仅单个联接件而没有任何间隔件。在其他实施方案中,联接件的数量可以是变化的,例如由间隔件分开的两个、三个、四个、五个、六个或更多个联接件。
在操作中,可通过芯构件103和联接单元117使支架105在导管101内朝远侧或近侧移动。为了将支架105移出导管101,在保持导管101静止的同时将芯构件103朝远侧移动,或者在将导管101朝近侧撤回的同时保持芯构件103静止。当将芯构件103朝远侧移动并且保持导管101静止时,近侧约束件119挤压最近侧间隔件125a并使间隔件125a-125d和联接件123a-123c朝远侧推进。联接件123a-123c与支架105之间的机械接合致使支架105随联接件123a-123c一起朝远侧移动,以使支架105在导管101的远侧区域109之外展开。相反,为了将支架105收回或以其他方式移动到导管101中,将芯构件103与导管101之间的相对移动相较于将支架105移出导管反过来,使得远侧约束件121的近侧区域挤压最远侧间隔件125d的远侧区域,并且由此致使间隔件125a-125d和联接件123a-123c相对于导管101缩回。联接件123a-123c与支架105之间的机械接合相应地相对于芯构件103保持支架105,这样支架105相对于导管101的近侧移动就使得能够将支架105回套到导管101的远侧区域109中。当支架105已经部分展开并且支架的一部分保持设置在联接件123a-123c中的至少一个(例如,最近侧联接件123a)与导管101的内表面113之间时,这是有用的,因为能够通过相对于导管101将芯构件103朝近侧移动(和/或相对于芯构件103将导管101朝远侧移动)来将支架105撤回至导管101的远侧开口115中。到联接件123a-123c和/或导管101已经移动到最近侧联接件123a越过导管101的远侧开口115并且支架105从构件123a与导管101之间释放的点之前,以这种方式进行的回套仍然是可能的。
联接件123a-123c和间隔件125a-125d可固定至芯构件103,以便不可相对于芯构件103以纵向/滑动方式或径向/旋转方式移动。可替代地,间隔件125a-125d和/或联接件123a-123c可联接至芯构件103(例如,安装在其上),使得间隔件125a-125d和/或联接件123a-123c可围绕芯构件103的纵向轴线旋转,和/或沿芯构件103纵向移动或滑动。在这类实施方案中,间隔件125a-125d和/或联接件123a-123c各自可具有将芯构件103接收在其中的内腔或孔口,使得间隔件125a-125d和/或联接件123a-123c可相对于芯构件103滑动和/或旋转。另外,在这类实施方案中,近侧约束件119和远侧约束件121沿芯构件103间隔开的纵向距离可稍微大于间隔件125a-125d和联接件123a-123c的组合长度,以便在最近侧间隔件125a和最远侧间隔件125d与对应地近侧约束件119和远侧约束件121之间留下一个或多个纵向间隙。当存在时,一个或多个纵向间隙允许间隔件125a-125d和联接件123a-123c沿芯构件103在约束件119、121之间纵向滑动。间隔件125a-125d和联接件123a-123c在约束件119、121之间的纵向运动范围大约等于一个或多个纵向间隙的总组合长度。
替代或除了一个或多个纵向间隙,联接单元117可包括芯构件103的外表面与间隔件125a-125d和联接件123a-123c的内表面之间的径向间隙。当间隔件125a-125d和/或联接件123a-123c被构造成具有比芯构件103的对应部分的外径略大的孔时,可形成这样的径向间隙。当存在时,径向间隙允许间隔件125a-125d和/或联接件123a-123c围绕芯构件103的纵向轴线在约束件119、121之间旋转。在间隔件125a-125d和联接件123a-123c的任一侧上存在至少一个最小大小的纵向间隙还可促进间隔件125a-125d和联接件123a-123c的可旋转性。
图2至图4示出根据本技术的实施方案配置的医疗装置递送系统的另一实施方案。如图2所示,所描绘的医疗装置递送系统200可包括可滑动地接收芯组件240的长形管或导管210,芯组件240被配置来携载支架201穿过导管210。图3示出芯组件240,为清楚起见没有描绘导管210和血管202。所描绘的导管210(参见图2和图4)具有近侧区域212和相反的远侧区域214、从近侧区域212延伸至远侧区域214的内腔216以及面向腔216的内表面218,远侧区域214可定位在患者体内的治疗部位。在远侧区域214处,导管210具有远侧开口(未示出),芯组件240可穿过远侧开口推进越过远侧区域214,以使支架201在血管202内扩展或展开。近侧区域212可包括导管毂222。导管210可限定在近侧区域212与远侧区域214之间延伸的大体上纵向尺寸A-A。当递送系统200在使用中时,纵向尺寸不需要沿其一部分或任何长度是笔直的。
导管101/210任选地可包括微导管。例如,导管101/210任选地可包括可从Medtronic Neurovascular of Irvine,California USA获得的各种长度中的任一长度的MARKSMANTM导管。导管101/210任选地可包括在远侧区域109/214附近具有约0.030英寸或更小的内径和/或3French或更小的外径的微导管。替代或除了这些规格,导管101/210可包括被配置成利用其远侧开口113经皮进入内颈动脉或内颈动脉远侧的神经血管系统内的另一位置的微导管。
芯组件240可包括芯构件260,所述芯构件260被配置成大体上纵向延伸穿过导管210的腔216。芯构件260可具有近侧区域或区段262和末端或远侧区域264,所述末端或远侧区域264任选地可包括尖端线圈265。芯构件260还可包括位于近侧区域262与远侧区域264之间的中间部分266,所述中间部分是芯构件260的一部分,当芯组件240处于图2至图4所示的展开前构型时,支架201定位或装配到所述部分上或在其上延伸。
芯构件260大体上可包括柔性和柱强度足以将支架201或其他医疗装置移动穿过导管210的任何一个或多个构件。芯构件260因此可包括丝、管(例如,海波管)、编织件、线圈或其他一种或多种合适的构件,或一根或多根丝、一根或多根管、一个或多个编织件、一个或多个线圈等的组合。图2至图4所描绘的芯构件260的实施方案具有多构件构造,包括近侧丝268、在近侧区域处连接至近侧丝268的远侧区域的管270(例如,海波管)、以及在近侧区域处连接至管270的远侧区域的远侧丝272。外层274(其可包括一层润滑材料,诸如PTFE(聚四氟乙烯或TEFLONTM)或其他润滑聚合物)可覆盖管270和/或近侧丝268的一部分或全部。近侧丝268和/或远侧丝272沿它们长度的一部分或全部在直径上可渐缩或变化。近侧丝268可包括一个或多个荧光安全(fluorosafe)标记物276,并且这类标记物可位于丝268的未被外层274覆盖(例如,在外层274近侧)的部分上。丝268的由一个或多个标记物276标记的和/或在任何外层274近侧的这个部分可包括裸金属外表面。
芯组件240还可包括可将医疗装置或支架201与芯构件260互连的近侧联接单元282和/或远侧联接单元290。近侧联接单元282可包括被配置来下伏于支架201并接合支架的内壁的一个或多个联接件123a-123c。以这种方式,近侧联接单元282与导管210的上覆内表面218配合以夹持支架201,使得近侧联接单元282可沿导管210并在导管210内移动支架201(例如,当使用者相对于导管210将芯构件260朝远侧推动和/或将芯构件朝近侧拉动时),从而导致支架201在导管腔216内的对应的远侧和/或近侧移动。
在一些实施方案中,近侧联接单元282可类似于上面相对于图1所描述的联接单元117的版本或实施方案中的任一种。例如,近侧联接单元282可包括近侧约束件119和远侧约束件121,所述近侧约束件119和远侧约束件121固定至芯构件260(例如,在所描绘的实施方案中,固定至其远侧丝272),以便不可相对于芯构件260以纵向/滑动方式或径向/旋转方式移动。近侧联接单元282还可包括由间隔件125a-125d分开的多个联接件123a-123c。联接件123a-123c和间隔件125a-125d可联接至芯构件260(例如,安装在其上),使得近侧联接单元282可围绕芯构件260的(例如,远侧丝272的)纵向轴线A-A旋转,和/或沿芯构件纵向移动或滑动。近侧约束件119和远侧约束件121中的一者或两者可具有小于近侧联接单元282的外径或其他径向最外侧尺寸的外径或其他径向最外侧尺寸,使得约束件119、121中的一者或两者在芯组件240的操作期间将倾向于不接触支架201的内表面。
在图2至图4所示的近侧联接单元282中,可通过近侧联接单元282使支架201在导管210内朝远侧或近侧移动,并且在一些实施方案中,在从导管210的远侧开口部分展开之后,可通过近侧联接单元282回套支架201,其方式类似于上面相对于图1中的联接单元117所描述的方式。
任选地,当处于图2至图4所示的递送构型时,近侧联接单元282的近侧边缘可恰好定位在支架201的近侧边缘远侧。在一些这样的实施方案中,这使得能够在至少有几毫米支架保留在导管210中回套支架201。因此,对于具有典型长度的支架201,可提供75%或更高的可回套性(即,当支架201已经展开75%或更多时,可回套支架201)。
远侧联接单元290可包括远侧接合构件292,所述远侧接合构件292可采取例如远侧装置覆盖件或远侧支架覆盖件的形式(一般地,为“远侧覆盖件”)。远侧覆盖件292可被配置来减少医疗装置或支架201(例如,其远侧部分或远侧区域)与导管210的内表面218之间的摩擦。例如,远侧覆盖件292可被配置为润滑的柔性结构,其具有可在支架201的至少一部分和/或芯构件260的中间部分266上延伸的自由的第一端部或区段292a,以及可(直接地或间接地)联接至芯构件260的固定的第二端部或区段292b。
远侧覆盖件292可具有第一或递送位置、构型或取向,其中远侧覆盖件可相对于远侧尖端264朝近侧延伸,或从第二区段292b或远侧覆盖件与芯构件260的(直接或间接)附接部朝近侧延伸,并且至少部分地围绕或覆盖支架201的远侧部分。远侧覆盖件292可能够从第一或递送取向移动至第二或回套位置、构型或取向(未示出),其中远侧覆盖件可外翻,使得远侧覆盖件的第一端部292a相对于远侧覆盖件292的第二端部292b定位在远侧,以使得能够回套芯组件240,不论是在具有由其携载的支架201的情况下还是没有支架的情况下。
远侧覆盖件292,特别地其第一端部292a,可包括联接至第二端部292b或与第二端部292b一体形成的一个或多个柔性的、大体上纵向延伸的条带、翼部或长形部分。远侧覆盖件292可由为远侧覆盖件所选的材料的管或由这种管的多个径向部分制造而成或以其他方式切割而成。在这类实施方案中,第一区段292a可形成为由管切割的多个纵向条带,并且第二区段292b可以是管的未切割(或类似地切割)的长度。因此,第二区段292b以及第一区段292a的朝近侧延伸的条带可形成单个一体装置或结构。在一些实施方案中,远侧覆盖件292包括仅一个或不超过两个条带、翼部或长形部分。
在一些实施方案中,远侧覆盖件292可包括管或纵向带缝管,并且第一区段292a可包括两个或更多个半圆柱形或部分圆柱形的条带或管部分,所述条带或管部分由在管的侧壁中形成或以其他方式定位的对应数量的大体上平行的纵向定向的切口或间隔部分开。因此,当处于扩展前状态时,如图2至图4所示,第一区段292a大体上可具有在支架或装置200的外表面与导管210的内表面218之间径向延伸或径向插置在其间的纵向分裂或纵向开槽的管的形状。
在各种实施方案中,第一区段292a的条带、翼部或长形部分可集体地跨越支架201的外表面的整个圆周(例如,在条带之间的切口是具有基本上零宽度的裂缝的情况下),或者大小被设定成略小于整个圆周(例如,在条带之间的切口是具有非零宽度的狭槽的情况下)。根据一些实施方案,第一区段292a的条带、翼部或长形部分的宽度可在约0.5mm与约4mm之间。所述宽度可以是约0.5mm至约1.5mm。根据一些实施方案,所述宽度可以是约1mm。
第一区段292a的条带、翼部或长形部分还可在支架201的远侧部分的至少一部分上纵向延伸。在各种实施方案中,第一区段292a在支架的远侧部分上延伸的距离可在约1mm与约3mm之间、或在约1.5mm与约2.5mm之间、或约2mm。
第一区段292a和第二区段292b可限定远侧覆盖件292的总长度。在一些实施方案中,所述总长度可以是在约4mm与约10mm之间。所述总长度还可以是在约5.5mm与约8.5mm之间。在一些实施方案中,所述总长度可以是约7mm。
第一区段292a的条带可具有基本上均匀的大小。例如,第一区段292a可包括各自跨越大约180度的两个条带、各自跨越大约120度的三个条带、各自跨越大约90度的四个条带,或者以其他方式被划分以集体地覆盖支架的圆周的全部或部分等。可替代地,在不脱离本公开的范围的情况下,条带可在角度大小设定和覆盖面积方面有所不同。在一个实施方案中,在第一区段292a中采用仅两个条带或管部分。使用仅两个条带可促进第一区段192a的径向扩展、远侧移动和/或折叠或外翻,如本文所讨论的,同时最小化血管腔中的自由或未被容纳的条带的数量以及由于在条带与血管壁之间的接触而损伤血管的任何可能性。
远侧覆盖件292可使用润滑和/或亲水材料诸如PTFE或
Figure BDA0003155053430000161
制造,但是可由其他合适的润滑材料或润滑聚合物制成。远侧覆盖件还可包括可共混至主材料(例如,PTFE)中以赋予射线不透性的射线不透材料。远侧覆盖件292可具有在约0.0005″与约0.003″之间的厚度。在一些实施方案中,远侧覆盖件可以是厚度约为0.001″的一个或多个PTFE条带。
远侧覆盖件292(例如,其第二端部292b)可固定至芯构件260(例如,固定至其远侧丝272或远侧尖端264),以便不可相对于芯构件260以纵向/滑动方式或径向/旋转方式移动。可替代地,如图2至图4所描绘,远侧覆盖件292(例如,其第二端部292b)可联接至芯构件260(例如,安装在其上),使得远侧覆盖件292可围绕芯构件260的(例如,远侧丝272的)纵向轴线A-A旋转,和/或沿芯构件纵向移动或滑动。在这类实施方案中,第二端部292b可具有将芯构件260接收在其中的内腔,使得远侧覆盖件292可相对于芯构件260滑动和/或旋转。另外,在这类实施方案中,远侧联接单元290还可包括固定至芯构件260并位于远侧覆盖件292(其第二端部292b)近侧的约束件294,和/或固定至芯构件260并位于远侧覆盖件292(其第二端部292b)远侧的约束件296。近侧约束件294和远侧约束件296沿芯构件260间隔开的纵向距离可稍微大于第二端部292b的长度,以便在第二端部292b与近侧约束件194和远侧约束件196中的一者或两者之间留下一个或多个纵向间隙297,这取决于第二端部292b在所述约束件之间的位置。当存在时,一个或多个纵向间隙197允许第二端部292b和/或远侧覆盖件292沿芯构件260在约束件294、296之间纵向滑动。第二端部292b和/或远侧覆盖件292在约束件294、296之间的纵向运动范围大约等于一个或多个纵向间隙297的总长度。
替代或除了一个或多个纵向间隙297,远侧联接单元290可包括芯构件260(例如,远侧丝272)的外表面与第二端部292b的内表面之间的径向间隙298。当第二端部292b被构造成具有比芯构件260的对应部分的外径略大的内腔直径时,可形成这样的径向间隙298。当存在时,径向间隙298允许远侧覆盖件292和/或第二端部292b围绕芯构件260的纵向轴线A-A在约束件294、296之间旋转。在第二端部292b的任一侧上存在至少一个极小大小的纵向间隙297也可促进远侧覆盖件的可旋转性。
近侧约束件294和远侧约束件296中的一者或两者可具有小于远侧覆盖件292的(例如,展开前)外径或其他径向最外侧尺寸的外径或其他径向最外侧尺寸,使得约束件294、296中的一者或两者在芯组件240的操作期间将倾向于不挤压或接触导管210的内表面218。
在图2至图4所描绘的实施方案中,远侧覆盖件292的第二端部292b包括内部套箍292c,所述内部套箍292c可包括(金属或聚合物)线圈(如图所描绘),或其他大体上刚性的、管状的或圆柱形的内部构件,诸如一小段相对坚硬的聚合物或金属管材。内部套箍292c可容纳在由第二端部292b形成的环形外壳或一个或多个套圈中,或以其他方式附接至第二端部292b或整合至其中,其方式为倾向于保持远侧覆盖件292在第二端部292b中的内径大于芯构件160(或其丝172)的相邻部分的外径。换句话讲,套箍292c可帮助保持在第二端部292b的内径与芯构件260或远侧丝272的外径之间存在径向间隙298。
第二端部292b的环形外壳或一个或多个套圈可通过以下方式形成:将远侧覆盖材料(例如,PTFE)的片材或管的一部分围绕套箍292c的侧壁并穿过其腔进行缠绕,并且将片材或管的缠绕部分的端部粘附、胶粘或热结合至片材或管的相邻的朝近侧延伸的部分。由此形成在套箍292c的近侧上粘附在一起的两个层。在远侧覆盖材料包括PTFE的情况下,可使用未烧结的PTFE以使得能够用热量和压力将材料的两个部分结合在一起,这在“普通的”或烧结的PTFE的情况下通常是不可能的。
在操作中,当支架201在导管110内朝远侧移动时,远侧覆盖件292、并且更特别地第一区段192a可大体上覆盖并保护支架201的远侧区域304。远侧覆盖件192可用作支承或缓冲层,所述支承或缓冲层例如抑制支架201(其中支架201包括编织支架)的远侧区域304的细丝端部接触导管110的内表面118,所述接触可损坏支架201和/或导管110,或者以其他方式折损支架201的结构完整性。由于远侧覆盖件192可由润滑材料制成,因此远侧覆盖件192可表现出允许支架201的远侧区域304相对容易地在导管110内轴向滑动的低摩擦系数。远侧覆盖件与导管内表面之间的摩擦系数可以是在约0.02与约0.4之间。例如,在远侧覆盖件和导管由PTFE形成的实施方案中,摩擦系数可以是约0.04。这类实施方案可有利地改进芯组件穿过导管的能力,特别是在曲折的脉管系统中。
另外,如图2至图4所示,在第一位置、构型或取向中,远侧覆盖件292的至少一部分可在支架201的远侧部分与导管210的内表面218之间至少部分地径向延伸或径向插置在其间。在第一取向中,远侧覆盖件292的第一区段292a可从第二区段292b在近侧取向上延伸至第一区段插置在支架201的远侧部分与导管210的内表面218之间的点。在此取向中,远侧覆盖件的第一区段可呈现“朝近侧定向”的位置或构型。
本文描述的远侧覆盖件292的实施方案之外的结构可用在芯组件240和/或远侧联接单元290中,以覆盖支架201的远侧区域304或以其他方式与其交互。例如,可采用具有纵向定向的朝近侧开口的腔的保护线圈或其他套筒。在其他实施方案中,远侧联接单元290可省略远侧覆盖件292,或远侧覆盖件可用类似于近侧联接单元282的部件替代。在采用远侧覆盖件292的情况下,它可连接至远侧尖端线圈265(例如,通过缠绕在线圈265的一部分或全部周围并对其进行包封)或者通过粘合剂或周围收缩管粘附至或联接至线圈的外表面。远侧覆盖件292可(直接地或间接地)联接至芯组件240的其他部分,诸如远侧丝272。
在采用可旋转近侧联接单元282和可旋转远侧覆盖件292两者的芯组件240的实施方案中,由于可旋转近侧联接单元282和远侧覆盖件292(其可旋转连接),支架201可能够相对于芯构件260围绕其纵向轴线A-A旋转。在这类实施方案中,支架201、近侧联接单元282和远侧覆盖件292可以此方式围绕芯构件一起旋转。因为支架、近侧接合构件和远侧覆盖件围绕芯构件的旋转抵消了血管扭转支架和/或芯组件的趋势,所以当支架201能够围绕芯构件260旋转时,芯组件240可更容易地推进穿过曲折的血管。此外,因为使用者的输入推力不会转向以使支架和/或芯构件扭转,所需的推力或递送力得以减小。扭转的支架和/或芯构件在支架脱离扭曲或展开时突然解开或“甩动”的趋势以及扭转的支架在展开时抵抗扩展的趋势也得以减小或消除。另外,在芯组件240的一些这样的实施方案中,使用者可通过尖端线圈265“操控”芯组件240,特别是在线圈265在其无应力构型中以一定角度弯曲的情况下。通过使芯构件260的远侧区域264旋转,这种线圈尖端可相对于支架201、联接单元282和/或远侧覆盖件292围绕轴线A-A旋转。因此,使用者可使线圈尖端指向芯组件的期望行进方向,并且在推进芯组件时,尖端将在所选方向上引导芯组件。
图5A是医疗装置递送系统500的联接单元517的放大透视图。图5B示出上覆有支架505的联接单元517。联接单元517包括由多个间隔件525a-525d分开的多个联接件523a-523c。近侧约束件519设置在最近侧间隔件525a近侧。近侧约束件519和联接单元517围绕芯构件503设置。图6A至图6C分别是图5A和图5B所示的联接单元517的联接件523的侧视图、端视图和透视图。图7是联接件523接合支架505的示意性剖视图。所描绘的支架505是编织的(尽管可使用如本文其他地方所公开的其他类型的支架)并且包括形成多个孔隙565的网片563,所述多个孔隙565由编织件的丝交叉或相交处的点分开。
同时参考图5A至图7,每个联接件523可具有板状构型,所述板状构型具有第一端面551和第二端面553以及在第一端面551与第二端面553之间延伸的侧表面555。在组装的递送系统500中,第一端面551和第二端面553可定向并保持与芯构件503的长轴基本上正交。这可通过以下方式来实现:将间隔件525a-525d配置成具有与每个间隔件525的纵向轴线(和/或芯构件503)正交的远侧端面和近侧端面,和/或最小化联接单元517的联接件和间隔件之间的纵向移动空间(或“余隙”)的量。每个联接件形成由凹陷部559分开的多个径向延伸的突出部557。在示出的实施方案中,存在由四个凹陷部559分开的四个突出部557。然而,在其他实施方案中,突出部的数量可以是变化的,例如由对应数量的凹陷部分开的两个、三个、四个、五个、六个、七个或更多个突出部。
突出部557可包括倒圆边缘,并且凹陷部559可包括倒圆凹入部。在递送系统500的使用期间,倒圆边缘可减轻突出部557抵靠上覆导管567的内壁的刮擦,这减少了颗粒的生成并减轻了对导管567的损坏。当递送系统500与诸如所描绘的支架505的编织支架一起使用时,凹陷部559可被设定大小以适应编织件丝交叉点的厚度,使得每个突出部可至少部分地延伸至支架505的位于相邻丝交叉点之间的孔隙565中,并且孔隙565周围的丝交叉点可至少部分地被接收在联接件的凹陷部559内。在其他实施方案中,突出部和/或凹陷可采取其他形式,例如具有由突出部形成的更尖锐或更平坦的峰。联接件523可通过光化学蚀刻、激光切割、模塑、机械加工或其他合适的工艺制造。
每个联接件523包括被配置来穿过其接收芯构件503的开口或中心孔口561。如先前所提及,孔口561的开口可大于芯构件503的直径,使得联接件523可围绕芯构件503的长轴旋转。
联接件523可被制成具有相对薄的和/或板状的构型。这种构型可促进形成足够小以配合在支架505的孔隙565内的突出部557。因此,联接件523的特征可在于沿第一端面551和第二端面553的最大直径D,以及沿侧表面555测量的厚度T。在一些实施方案中,直径D是厚度T的至少五倍大。在至少一个实施方案中,厚度T是在大约25微米-100微米之间或25微米-75微米之间,例如大约50微米(大约0.002")。
为了沿导管567有效地推动或拉动支架505,可将联接件523制成是刚性的(例如,是在递送系统的典型使用中遇到的力所不可压缩的)。联接件523的刚性可归因于它们的材料组成、它们的形状/构型或两者。在一些实施方案中,联接件523由金属(例如,不锈钢、镍钛诺等)或刚性聚合物(例如,聚酰亚胺)或两者制成。在一些实施方案中,即使联接件由刚性材料制成,但是基于结构特性,联接件本身也可以是非刚性的并且是至少部分地可压缩的。
间隔件525可以是外径小于联接件523的最大外径的基本上圆柱形的主体。在一些实施方案中,间隔件525包括被设定大小和构型以允许间隔件525可旋转地安装在芯构件503之上的中心孔口(未示出)。如前面先前所提及的,间隔件525可具有与芯构件503的长轴正交的端壁。这些正交的端壁可有助于保持联接件523相对于芯构件503的正交取向,以防止损失与支架505的接合。
在一些实施方案中,联接单元517可被配置来接合支架505的仅近侧部分(例如,仅近侧半部,仅最近侧三分之一等)。在其他实施方案中,联接单元517可基本上沿其整个长度接合支架505。
联接件523可与支架505机械地互锁或接合,使得每个突出部557至少部分地被接收在孔隙565中的一个内。间隔件可被配置成具有一定长度,使得相邻联接件523(例如,联接件523a和相邻的联接件523b)的突出部557纵向间隔开一定距离,所述距离等于支架505处于导管567的内径时支架的“孔隙间距”(纵向相邻孔隙565的中心之间的距离),或者更典型地,等于支架505的孔隙间距的整数倍。因此,每个突出部可延伸至支架505的孔隙565中的一个中并与之接合。在一些实施方案中,相邻联接件523可接合支架505的纵向相邻孔隙565;在其他实施方案中,相邻联接件523接合不是纵向相邻的、而是通过一个或多个居间孔隙纵向间隔开的孔隙565。因此,第一联接件523a和第二联接件523b可与彼此间隔对应于支架505的孔隙间距的纵向距离,或者间隔对应于孔隙间距的整数倍的纵向距离。
突出部557与孔隙565之间的交互可在支架联接件523与孔隙565之间产生机械互锁。这与常规的可压缩垫形成对比,常规的可压缩垫弹性地推压整个的支架、包括丝交叉点。在至少一些实施方案中,由联接件523提供的机械互锁固定支架505,而不抵压支架505的丝交叉点。在一些实施方案中,联接件523被配置来在给定导管大小内(例如,在0.017"、0.021"或0.027"导管(内径)内)固定一系列不同支架大小。
需注意,图5A至图7的递送系统500的各种部件可并入至图1的递送系统100中或图2至图4的递送系统200中。例如,联接单元517的任何所公开实施方案可用作递送系统100或递送系统200的联接单元。类似地,联接件523的任何实施方案可用作递送系统100或递送系统200的一个或多个联接件,和/或间隔件525的任何实施方案可用作递送系统100或递送系统200的一个或多个间隔件。
结论
本公开并不意图是详尽的,而且也不意图将本技术局限于本文公开的精确形式。尽管本文出于说明性目的公开了具体实施方案,但是在不背离本技术的情况下可以进行各种等效修改,如相关领域的普通技术人员将认识到的。在一些情况下,未详细示出和/或描述众所周知的结构和功能,以避免不必要地模糊对本技术的实施方案的描述。尽管在本文中可按特定顺序呈现方法的步骤,但是在替代实施方案中,这些步骤可具有另一种合适的顺序。类似地,在具体实施方案的上下文中公开的本技术的某些方面可在其他实施方案中组合或除去。此外,虽然已经在某些实施方案的上下文中公开了与这些实施方案相关联的优点,但是其他实施方案也可表现出这类优点,并且并非所有实施方案都必须表现出这类优点或本文公开的其他优点以便落在本技术的范围内。因此,本公开和相关联技术可涵盖在本文中未明确示出和/或描述的其他实施方案。
在整个本公开中,除非上下文另外明确指出,否则单数术语“一个”、“一种”和“所述”包括复数指代物。类似地,关于两个或更多个项目的列表,除非字词“或”明确地限于仅意指排除其他项目的单个项目,否则在这样的列表中使用“或”将被解释为包括(a)列表中的任何单个项目,(b)列表中的所有项目,或(c)列表中项目的任何组合。另外,在整个本公开中,使用术语“包括”等意指至少包括一个或多个所陈述特征,使得不排除任何更大数量的相同特征和/或一个或多个另外类型的特征。诸如“上”、“下”、“前”、“后”、“竖直”和“水平”的方向术语在本文中可用于表达和阐明各种元件之间的关系。应当理解,这类术语不表示绝对取向。本文中对“一个实施方案”、“实施方案”或类似表述的引用意味着结合所述实施方案描述的特定特征、结构、操作或特性可包括在本技术的至少一个实施方案中。因此,这类短语或表述在本文中的出现不一定都是指同一实施方案。此外,各种特定特征、结构、操作或特性可以任何合适的方式组合在一个或多个实施方案中。

Claims (10)

1.一种支架递送系统,包括:
芯构件,所述芯构件具有远侧段;
围绕所述芯构件的远侧段定位的联接单元,所述联接单元包括:
联接至所述芯构件的远侧段的近侧约束件;
远侧约束件,所述远侧约束件在所述近侧约束件的远侧的位置处联接至所述芯构件的远侧段;
两个或更多个板,所述两个或更多个板在所述近侧约束件与所述远侧约束件之间可滑动地联接至所述芯构件的远侧段;以及
一个或多个间隔件,所述一个或多个间隔件在所述近侧约束件与所述远侧约束件之间联接至所述芯构件的远侧段,
其中所述近侧约束件和所述远侧约束件沿着所述芯构件间隔开的纵向距离大于所述两个或更多个板以及在所述近侧约束件与所述远侧约束件之间联接至所述芯构件的远侧段的所述一个或多个间隔件的组合长度;以及
支架,所述支架沿所述芯构件的远侧段延伸,使得所述支架的内表面由所述两个或更多个板中的至少一个板接合。
2.如权利要求1所述的支架递送系统,其中所述纵向距离使得板能够相对于所述近侧约束件和所述远侧约束件器沿着所述芯构件的远侧段纵向滑动。
3.如权利要求1所述的支架递送系统,其中所述一个或多个间隔件包括设置在两个板之间的间隔件。
4.如权利要求1所述的支架递送系统,其中:
所述两个或更多个板包括第一板、第二板和第三板,
所述一个或多个间隔件包括第一间隔件和第二间隔件,并且
所述第一间隔件设置在所述第一板和所述第二板之间,所述第二间隔件设置在所述第二板和所述第三板之间。
5.如权利要求4所述的支架递送系统,其中所述近侧约束件和所述远侧约束件沿着所述芯构件间隔开的纵向距离大于所述第一板、所述第二板和所述第三板以及所述第一间隔件和所述第二间隔件的组合长度。
6.如权利要求1所述的支架递送系统,其中所述两个或更多个板的至少一个突出部与所述支架互锁,使得所述突出部被至少部分地接收在所述支架的孔隙内。
7.如权利要求1所述的支架递送系统,其中所述两个或更多个板彼此间隔开的距离对应于所述支架的纵向相邻孔隙的中心之间的距离。
8.一种支架递送系统,包括:
导管,所述导管具有腔和沿所述腔延伸的内表面;
芯构件,所述芯构件在所述导管的腔内延伸;
可滑动地安装至所述芯构件的第一联接件和第二联接件,所述第一联接件和所述第二联接件中的每一个都包括:
第一端面、第二端面以及在所述第一端面与所述第二端面之间延伸的侧表面;以及
孔口,所述孔口穿过所述第一端面和所述第二端面延伸,所述芯构件延伸穿过所述孔口,所述孔口在所述芯构件的外表面和联接件的内表面之间限定径向间隙;
安装在所述芯构件上的一个或多个间隔件;
在所述第一联接件、所述第二联接件、以及所述一个或多个间隔件的近侧的位置处安装在所述芯构件上的近侧约束件;
在所述第一联接件、所述第二联接件、以及所述一个或多个间隔件的远侧的位置处安装在所述芯构件上的远侧约束件,所述远侧约束件与所述近侧约束件间隔开的纵向距离大于所述第一联接件、所述第二联接件以及所述一个或多个间隔件的组合长度;以及
支架,所述支架沿着所述芯构件延伸并且沿径向设置在所述导管的内表面与所述第一联接件和所述第二联接件之间。
9.如权利要求8所述的支架递送系统,其中所述支架包括形成多个孔隙的网片,并且其中所述第一联接件和所述第二联接件彼此间隔开的距离对应于所述支架的纵向相邻孔隙的中心之间的距离。
10.如权利要求8所述的支架递送系统,其中所述间隔件的径向最外侧尺寸小于所述第一联接件和所述第二联接件的径向最外侧尺寸。
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