CN107157615B - 一种覆膜支架 - Google Patents

一种覆膜支架 Download PDF

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CN107157615B
CN107157615B CN201610127211.0A CN201610127211A CN107157615B CN 107157615 B CN107157615 B CN 107157615B CN 201610127211 A CN201610127211 A CN 201610127211A CN 107157615 B CN107157615 B CN 107157615B
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stent
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CN107157615A (zh
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谷涌泉
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Beijing Huayan Vascular Disease Diagnosis and Treatment Industry Technology Innovation Strategic Alliance
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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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-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
    • 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
    • A61F2220/0008Fixation appliances for connecting prostheses to the body
    • A61F2220/0016Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
    • 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
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00011Metals or alloys

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Pulmonology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Transplantation (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

本发明公开了一种覆膜支架,属于医疗器械领域。一种覆膜支架,由两个支架单元组成,每个支架单元由多圈金属支架、包被在多圈金属支架表面的覆膜和与多圈金属支架顶端相连的金属裸支架组成,在支架单元近端的覆膜外周设有至少一个环形膜片。本发明的优点是:本发明采用两个位置可调的覆膜支架单元,手术操作简单,释放容易,直接穿刺即可完成,创伤小、不易移位,手术成功率非常高,减少病人的痛苦,效果可靠,能更好地保护肾动脉;覆膜支架与血管贴壁性好,有效避免支架与血管之间在部分位置上产生缝隙或空隙,降低“内漏”发生率。

Description

一种覆膜支架
技术领域
本发明涉及一种新型覆膜支架,属于医疗器械领域。
背景技术
传统腔内治疗腹主动脉瘤的覆膜支架是一种一个主体腹膜支架和一个分支腹膜支架组成的结构,也有个别的是一体式覆膜支架,包括腹主动脉和双髂动脉分支。
“内漏”是腔内治疗主动脉瘤最常见的并发症,即覆膜支架植入术后,血液以各种途径继续流入假腔的现象,根本原因是支架释放后未能完全隔绝瘤腔与动脉血流间的交通。持续内漏会导致血管瘤增大,血管壁减薄,乃至破裂,最终导致病人死亡。
现有的覆膜支架在设计上最大的缺点是操作复杂,手术中释放较困难。目前尚未有一种操作简单且能有效降低“内漏”现象的覆膜支架。
此外,目前对于近肾动脉的腹主动脉瘤,由于瘤颈短,无法用常规的覆膜支架修复,需要采用分支血管支架或者开窗技术或者烟囱技术,这三类技术的操作非常复杂,因此有时候不得不牺牲一侧肾动脉,这样会导致患者术后出现高血压,严重者出现肾功能衰竭。
发明内容
本发明要解决的技术问题是提供一种操作简单、释放方便、而且降低“内漏”发生、而且更好地保护肾动脉的新型覆膜支架。
为实现上述目的,本发明采用以下技术方案:
一种覆膜支架,由两个支架单元组成,每个支架单元由多圈金属支架、包被在多圈金属支架表面的覆膜和与多圈金属支架顶端相连的金属裸支架组成,在支架单元近端的覆膜外周设有至少一个环形膜片。
所述环形膜片设于距离覆膜上缘0.5cm-2cm处,优选0.5cm-1.5cm处,最优选0.5cm-1cm。
本发明采用两个支架单元,它们在手术中的位置分别可调。根据我们的研究,90%患者的双肾动脉不在同一平面。本发明的两个支架单元在释放时,可以根据肾动脉的位置很容易调整覆膜支架的位置,双侧不放置在同一平面,这样可以有效避免内漏的发生,起到更好的封闭隔绝动脉瘤的效果。
所述环形膜片的厚度为1mm-2mm,优选2mm;宽度为1mm-3mm,优选2mm。
所述环形膜片为1-3个,优选2个,相邻两个环形膜片的间距为1mm-3mm,优选2mm,间距的选择取决于环形膜片的高度。手术中,两个支架单元的环形膜片通过环形膜片相互吻合搭接、或凹凸相嵌,使两个支架单元连接在一起成为完整的覆膜支架,同时该覆膜支架整体紧密贴合在血管壁上,并且有效隔绝血管和瘤腔,防范“内漏”发生。每一个支架单元上的环形膜片数量可以相同或不同。例如两个支架单元均设有1个或2个环形膜片;或一侧支架单元为1个环形膜片,另一侧支架单元为2个环形膜片;或一侧支架单元为2个环形膜片,另一侧支架单元为3个环形膜片;环形膜片的数量越多,连接和密封瘤腔的效果越好。
所述支架单元的远端为直筒型或逐渐膨大的喇叭口型。
所述覆膜和环形膜片由具有良好生物相容性的高分子材料制成,包括但不限于聚四氟乙烯、涤纶、聚酯、聚氨基甲酸乙酯等,保证血液向动脉远端流去,同时隔绝了动脉瘤。
所述金属裸支架上设有防脱固定结构,例如倒钩,用于将覆膜支架固定在主动脉壁上。该金属裸支架主要目的是防止覆膜支架相互影响对侧的血流,保持一定的张力和提供部分径向支撑力。
所述多圈金属支架沿覆膜的轴向依次布置,且每圈金属支架可沿覆膜的径向弹性形变。多圈金属支架采用合金丝加工而成,由多个波形单元的封闭的圆柱状结构组成。
所述的合金丝为不锈钢、记忆合金等金属材料制成。
本发明的优点是:本发明采用两个位置可调的覆膜支架单元,手术操作简单,释放容易,直接穿刺即可完成,创伤小、不易移位,手术成功率非常高,减少病人的痛苦,效果可靠,能更好地保护肾动脉;覆膜支架与血管贴壁性好,有效避免支架与血管之间在部分位置上产生缝隙或空隙,降低“内漏”发生率。
以下通过附图和具体实施方式详细说明本发明的技术方案,并不以此限定本发明的实施范围,凡依照本发明披露内容所进行的本领域等同替换,均属于本发明的保护范围。
附图说明
图1为实施例1支架单元结构示意图
图2为实施例1使用状态参考图
图3为实施例2支架单元结构示意图
图4为实施例2的使用状态参考图
具体实施方式
实施例1
参照图1和图2所示,一种覆膜支架,由两个支架单元组成,每个支架单元由多圈金属支架11、包被在多圈金属支架表面的覆膜12和与多圈金属支架顶端相连的金属裸支架13组成,在支架单元近端的覆膜12外周设有一个环形膜片14。
环形膜片14设于距离覆膜12上缘0.5cm处,环形膜片14的厚度为2mm,宽度为2mm。支架单元的远端为直筒型。金属裸支架13上设有防脱固定结构131;覆膜12和环形膜片14由具有良好生物相容性的高分子材料聚四氟乙烯制成;多圈金属支架沿覆膜的轴向依次布置,且每圈金属支架可沿覆膜的径向弹性形变;多圈金属支架采用合金丝加工而成,由多个波形单元的封闭的圆柱状结构组成。
实施例2
参照图3和图4所示,一种覆膜支架,由两个支架单元组成,每个支架单元由多圈金属支架11、包被在多圈金属支架表面的覆膜12和与多圈金属支架顶端相连的金属裸支架13组成,在一侧支架单元近端的覆膜外周设有一个环形膜片14,再另一侧支架单元近端的覆膜外周设有两个环形膜片14。
设有一个环形膜片的支架单元的环形膜片14设于距离覆膜上缘0.5cm处,环形膜片的厚度为2mm,宽度为2mm。设有两个环形膜片的支架单元的上方的环形膜片设于距离覆膜上缘0.5cm处,两个环形膜片的间距为2mm,两个环形膜片的厚度为2mm,宽度为2mm。支架单元的远端为直筒型。金属裸支架13上设有防脱固定结构131;覆膜12和环形膜片14由具有良好生物相容性的高分子材料聚氨基甲酸乙酯制成;多圈金属支架11沿覆膜12的轴向依次布置,且每圈金属支架可沿覆膜的径向弹性形变;多圈金属支架采用合金丝加工而成,由多个波形单元的封闭的圆柱状结构组成。

Claims (7)

1.一种覆膜支架,其特征在于:由两个支架单元组成,每个支架单元由多圈金属支架、包被在多圈金属支架表面的覆膜和与多圈金属支架顶端相连的金属裸支架组成,在支架单元近端的覆膜外周设有至少一个环形膜片,所述环形膜片设于距离覆膜上缘0.5-2cm处,所述支架单元的远端为直筒型或逐渐膨大的喇叭口型;两个支架单元的环形膜片的数量不同;环形膜片的厚度为1mm-2mm,宽度为1mm-3mm。
2.根据权利要求1所述的覆膜支架,其特征在于:所述环形膜片设于距离覆膜上缘0.5cm-1.5cm处。
3.根据权利要求2所述的覆膜支架,其特征在于:所述环形膜片的厚度为2mm,宽度为2mm。
4.根据权利要求1所述的覆膜支架,其特征在于:所述环形膜片为1-3个。
5.根据权利要求4所述的覆膜支架,其特征在于:所述环形膜片为2-3个,相邻两个环形膜片的间距为1mm-3mm。
6.根据权利要求4所述的覆膜支架,其特征在于:相邻两个环形膜片的间距为2mm。
7.根据权利要求1至6中任何一项所述的覆膜支架,其特征在于:所述金属裸支架上设有防脱固定结构;所述覆膜和环形膜片由具有良好生物相容性的高分子材料制成;所述多圈金属支架沿覆膜的轴向依次布置,且每圈金属支架可沿覆膜的径向弹性形变;多圈金属支架采用合金丝加工而成,由多个波形单元的封闭的圆柱状结构组成。
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Publication number Priority date Publication date Assignee Title
US6290731B1 (en) * 1998-03-30 2001-09-18 Cordis Corporation Aortic graft having a precursor gasket for repairing an abdominal aortic aneurysm
CN101917929A (zh) * 2007-10-04 2010-12-15 特里瓦斯库拉尔公司 用于低型面经皮递送的模块化脉管移植物
CN104905891A (zh) * 2008-05-15 2015-09-16 阿尔图拉医疗公司 用于治疗腹主动脉瘤的装置和方法
CN103260548A (zh) * 2009-12-01 2013-08-21 阿尔图拉医疗公司 模块化内移植物设备以及相关***和方法
CN105213076A (zh) * 2014-06-12 2016-01-06 微创心脉医疗科技(上海)有限公司 一种人造瘤颈及其制备方法
CN205626187U (zh) * 2016-03-07 2016-10-12 谷涌泉 一种覆膜支架

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