CN106420127A - 一种顺应食管蠕动性全贴合食管支架 - Google Patents

一种顺应食管蠕动性全贴合食管支架 Download PDF

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CN106420127A
CN106420127A CN201610897406.3A CN201610897406A CN106420127A CN 106420127 A CN106420127 A CN 106420127A CN 201610897406 A CN201610897406 A CN 201610897406A CN 106420127 A CN106420127 A CN 106420127A
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esophageal
stent
silk screen
esophageal stent
folding
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韩新巍
任克伟
路慧彬
王艳丽
吴刚
任建庄
马波
李宗明
张全会
李亚华
张文哲
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First Affiliated Hospital of Zhengzhou University
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任克伟
路慧彬
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    • 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
    • A61F2/82Devices 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
    • A61F2/88Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
    • 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
    • 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
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • 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
    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0083Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using hook and loop-type fasteners
    • 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004Rounded shapes, e.g. with rounded corners
    • A61F2230/0008Rounded shapes, e.g. with rounded corners elliptical or oval
    • 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
    • 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
    • A61F2230/0065Three-dimensional shapes toroidal, e.g. ring-shaped, doughnut-shaped
    • 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
    • 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
    • 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0065Additional features; Implant or prostheses properties not otherwise provided for telescopic

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Abstract

本发明涉及一种顺应食管蠕动性全贴合食管支架,所述食管支架由两端粗、中间细的三段顺滑连接组成,两端部段为单层的网状围成的筒状,中间段由等宽长条丝网螺旋缠绕而成,所述长条丝网的上端设置有上钩,所述长条丝网的下端设置有下钩,所述长条丝网在螺旋缠绕过程中其上的上钩与下钩相互扣合,所述长条丝网的截面呈台阶状。该食管支架由等宽长条丝网螺旋缠绕而成,使其具有伸缩性与随动性,能够最大限度的将食管的蠕动过程传递给食物,使其更容易完成下咽,而且支架的随动性更进一步增强了支架的抗移位性,极大地改善了支架对食管的功能和结构影响;该支架使患者能够更加舒适且与人体食管壁全方位贴合,该支架最大限度避免推压气管。

Description

一种顺应食管蠕动性全贴合食管支架
技术领域
本发明涉及医疗器械技术领域,具体涉及一种顺应食管蠕动性全贴合食管支架。
背景技术
食管支架对良/恶性食管狭窄、急性食管穿孔、食管瘘及责门失弛缓症治疗效果较好,尤其对急性食管穿孔和食管瘘患者放置全腹膜支架后,可有效封堵漏口,以微创的方法治疗急危重症。食管原位癌和癌前病变内镜下治疗,食管狭窄内镜下扩张,晚期食管癌放疗等可引起术后食管狭窄、术中食管穿孔和治疗后食管瘘的发生,使用全覆膜食管支架可有效减少并治疗以上并发症。目前临床使用的食管支架主要为自膨性金属支架(SEMS)和自膨性塑料支架(SEPS)。SEMS的缺点为:支架两端张力较大,容易引起新生肉芽组织生长,引起再次狭窄;支架坚硬无蠕动性,置入后局部不适与疼痛发生率高。而SEPS的缺点为:置入技术复杂,置入过程痛苦,在置入后支架移位发生率高。
正常人体食管内腔为椭圆形,而现有食管支架全部为圆筒状,此种食管支架不能对食管壁进行全贴合,另外现有支架不能做到随食管进行仿形运动,食管的运动不能由支架传递到食物,就不能很好起到蠕动食物使其下咽的目的;支架不能蠕动还是下咽唾液与食物时有不同程度的不适与痛苦的原因;圆筒状外形的食管支架,还有一个最严重的并发症,就是有可能推压其前方的气管,导致致命性的气管狭窄。例如公开号为CN104107099A的中国发明专利公开了一种食管支架,其中的涨圈式设计只能防脱落,不能对食物传递食管的蠕动,另外这种支架也不能对食管壁进行全贴合。
发明内容
为克服上述缺陷,本发明的目的即在于提供一种更加舒适的抗蠕动性全贴合食管支架。
本发明的目的是通过以下技术方案来实现的:
本发明的一种顺应食管蠕动性全贴合食管支架,所述食管支架由两端粗、中间细的三段顺滑连接组成,两端部段为单层的网状围成的筒状,中间段由等宽长条丝网螺旋缠绕而成,所述长条丝网的上端设置有上钩,所述长条丝网的下端设置有下钩,所述长条丝网在螺旋缠绕过程中其上的上钩与下钩相互扣合,所述长条丝网的截面呈台阶状。
进一步,所述中间段的截面为椭圆形。
进一步,所述长条丝网的截面呈三折状,分别为依次连接的第一折、第二折及第三折,所述第一折与第三折平行设置,所述上钩设置在第一折的上端,所述下钩设置在第三折的下端,所述第三折相对于第一折朝内设置。
进一步,所述食管支架的上端和下端均为平齐设置。
进一步,所述上钩和下钩均由片状条镍钛记忆合金折弯而成。
进一步,所述长条丝网的材质为镍钛记忆合金。
进一步,所述长条丝网上的网丝孔呈菱形。
进一步,所述上钩与长条丝网上端的连接处呈弧形状,所述下钩与长条丝网下端的连接处呈弧形状;所述食管支架的上端和下端开口均呈杯口样或蘑菇样膨大。
进一步,所述食管支架的两侧分别有三个标记块,所述标记块由黄金丝缠绕而成,所述食管支架的两端各设有网拉环。
进一步,所述长条丝网的内外侧均设置有覆膜或单纯内侧覆膜或单纯外侧覆膜或部分覆膜;所述食管支架的上端和下端开口上每两条网丝的交叉处设置有拉丝扣。
本发明提供的一种顺应食管蠕动功能和食管椭圆形解剖结构全贴合食管支架,该食管支架由两端粗、中间细的三段顺滑连接组成,两端部段为单层的网状围成的筒状,中间段由等宽长条丝网螺旋缠绕而成,使其具有伸缩性与随动性,能够最大限度的将食管的蠕动过程传递给食物,使其更容易完成下咽,而且支架的随动性更进一步增强了支架的抗移位性;同时该支架使患者能够更加舒适且与人体食管壁全方位贴合,该支架最大限度的避免推压气管。
附图说明
为了易于说明,本发明由下述的较佳实施例及附图作以详细描述。
图1为本发明一种顺应食管蠕动性全贴合食管支架的结构图;
图2为本发明一种顺应食管蠕动性全贴合食管支架的俯视图;
图3为本发明一种顺应食管蠕动性全贴合食管支架的螺旋示意图;
图4为本发明一种顺应食管蠕动性全贴合食管支架的截面图;
图5为本发明一种顺应食管蠕动性全贴合食管支架中长条丝网的截面图。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白,以下结合附图及实施例,对本发明进行进一步详细说明。应当理解,此处所描述的具体实施例仅仅用以解释本发明,并不用于限定本发明。
本发明的一种顺应食管蠕动功能和食管椭圆形解剖结构全贴合食管支架,该食管支架由两端粗、中间细的三段顺滑连接组成,两端部段为单层的网状围成的筒状,中间段由等宽长条丝网1螺旋缠绕而成,该长条丝网1的上端设置有上钩2,该长条丝网1的下端设置有下钩3,该长条丝网1在螺旋缠绕过程中其上的上钩2与下钩3相互扣合,该长条丝网1的截面呈台阶状,台阶状使得下钩3与上钩2在竖直方向上有一定的位置差,两者上下扣合后刚好在一条竖直线上,保证管状食管支架的形状均匀性,上下粗细相等;该食管支架的上端和下端均为平齐设置,该食管支架的上下端开口呈杯口样或蘑菇样,便于与食管壁更好的贴合及固定。
其中,该食管支架的截面为椭圆形,符合人体食管内腔形状,更方便与人体食管壁全方位贴合。如图5所示,该长条丝网1的截面呈三折状,分别为依次连接的第一折4、第二折5及第三折6,该第一折4与第三折6平行设置,该上钩2设置在第一折4的上端,该下钩3设置在第三折6的下端,该第三折6相对于第一折4朝内设置;该上钩2与长条丝网1上端的连接处呈弧形状,该下钩3与长条丝网1下端的连接处呈弧形状,弧形状使得上钩2和下钩3扣合更方便稳固。
该上钩2和下钩3均由片状条镍钛记忆合金折弯而成,该长条丝网1的材质为镍钛记忆合金,镍钛记忆合金材质性能更稳定可靠,适合用作人体植入型器材。该长条丝网1上的网丝孔呈菱形,菱形的变形随动性能更佳。该长条丝网1内侧设置有覆膜(未图示),覆膜能够减小食物的阻力,便于下咽。
本发明提供的一种顺应食管蠕动性全贴合食管支架,该食管支架由等宽长条丝网1螺旋缠绕而成,使其具有伸缩性与随动性,能够最大限度的将食管的蠕动过程传递给食物,使其更容易完成下咽,而且支架的随动性更进一步增强了支架的抗蠕动性;同时该支架使患者能够更加舒适且与人体食管全方位贴合。采用整体为椭圆形筒状的设计,全面贴合食管内壁,使患者能够更加舒适且全方位贴合可以增加支架的抗蠕动性。
食管支架的上下端开口呈杯口样或蘑菇样膨大;食管支架的两侧分别有三个标记块7,该标记块7由黄金丝缠绕而成;食管支架两端各有一网拉环8,食管支架的上端和下端开口上每两条网丝的交叉处设置有拉丝扣9,开口处的拉丝扣9穿过网丝,两端边界网丝各设置有一个网拉环8,当拉动两端的网拉环8,食管支架可以收缩变细,便于放置时候的塞入及更换时候的取出,椭圆形食管支架每一节的长轴顶端均放置有对称的标记块7,标记块7材质为纯金,便于后期观察支架的节与节之间的轴向收缩量以及每一节内部的径向收缩量。
长条丝网1的内外侧均设置有覆膜或单纯内侧覆膜、单纯外侧覆膜或部分覆膜,该覆膜为特殊的高分子医用聚酯膜。
安装支架时,在X光机的监视下,将该抗蠕动性全贴合食管支架套在通用的防脱落食管安放支架上,经过拉伸变形后送入食管癌变位置,防脱落食管安放支架到位后取出,其上的食管支架慢慢膨胀恢复拉伸变形前的形状将堵塞的食管撑开,即可对患者完成安装。
以上所述仅为本发明的较佳实施例而已,并不用以限制本发明,凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等,均应包含在本发明的保护范围之内。

Claims (10)

1.一种顺应食管蠕动性全贴合食管支架,其特征在于,所述食管支架由两端粗、中间细的三段顺滑连接组成,两端部段为单层的网状围成的筒状,中间段由等宽长条丝网螺旋缠绕而成,所述长条丝网的上端设置有上钩,所述长条丝网的下端设置有下钩,所述长条丝网在螺旋缠绕过程中其上的上钩与下钩相互扣合,所述长条丝网的截面呈台阶状。
2.根据权利要求1所述的一种顺应食管蠕动性全贴合食管支架,其特征在于,所述中间段的截面为椭圆形。
3.根据权利要求1所述的一种顺应食管蠕动性全贴合食管支架,其特征在于,所述长条丝网的截面呈三折状,分别为依次连接的第一折、第二折及第三折,所述第一折与第三折平行设置,所述上钩设置在第一折的上端,所述下钩设置在第三折的下端,所述第三折相对于第一折朝内设置。
4.根据权利要求1所述的一种顺应食管蠕动性全贴合食管支架,其特征在于,所述食管支架的上端和下端均为平齐设置。
5.根据权利要求4所述的一种顺应食管蠕动性全贴合食管支架,其特征在于,所述上钩和下钩均由片状条镍钛记忆合金折弯而成。
6.根据权利要求1所述的一种顺应食管蠕动性全贴合食管支架,其特征在于,所述长条丝网的材质为镍钛记忆合金。
7.根据权利要求1所述的一种顺应食管蠕动性全贴合食管支架,其特征在于,所述长条丝网上的网丝孔呈菱形。
8.根据权利要求1所述的一种顺应食管蠕动性全贴合食管支架,其特征在于,所述上钩与长条丝网上端的连接处呈弧形状,所述下钩与长条丝网下端的连接处呈弧形状;所述食管支架的上端和下端开口均呈杯口样或蘑菇样膨大。
9.根据权利要求1所述的一种顺应食管蠕动性全贴合食管支架,其特征在于,所述食管支架的两侧分别有三个标记块,所述标记块由黄金丝缠绕而成,所述食管支架的两端各设有网拉环。
10.根据权利要求1所述的一种顺应食管蠕动性全贴合食管支架,其特征在于,所述长条丝网的内外侧均设置有覆膜或单纯内侧覆膜或单纯外侧覆膜或部分覆膜;所述食管支架的上端和下端开口上每两条网丝的交叉处设置有拉丝扣。
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