CN101143114B - 双层静脉滤器 - Google Patents

双层静脉滤器 Download PDF

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CN101143114B
CN101143114B CN2006101160639A CN200610116063A CN101143114B CN 101143114 B CN101143114 B CN 101143114B CN 2006101160639 A CN2006101160639 A CN 2006101160639A CN 200610116063 A CN200610116063 A CN 200610116063A CN 101143114 B CN101143114 B CN 101143114B
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可大年
周庆亮
梅奇峰
张宪国
罗七一
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Minimally Invasive Investment Holdings Ltd
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Microport Medical Shanghai Co Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/01—Filters implantable into blood vessels
    • A61F2/012—Multiple filtering units
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/01—Filters implantable into blood vessels
    • A61F2/0105—Open ended, i.e. legs gathered only at one side
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/01—Filters implantable into blood vessels
    • A61F2002/016—Filters implantable into blood vessels made from wire-like elements
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
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    • A61F2230/005—Rosette-shaped, e.g. star-shaped
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0073—Quadric-shaped
    • A61F2230/008—Quadric-shaped paraboloidal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0093—Umbrella-shaped, e.g. mushroom-shaped

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  • Oral & Maxillofacial Surgery (AREA)
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Abstract

本发明属于生物医用材料中人体植入器械领域，具体地说涉及一种用于血管中，特别是腔静脉中血栓或其他块状物过滤和捕捉的装置。包括上下两层滤网，所述上下两层滤网之间通过设置在滤网中心的连杆相连，所述上层滤网和下层滤网均由若干根从滤网中心引出的单向并行的滤丝组成，所述滤丝呈菊花瓣状由滤网中心向四周发散，所述上层滤网的滤丝分布比下层滤网的滤丝分布密。本发明通过设置两层滤网，使下层滤网的滤丝分布较疏，用于过滤较大的血栓；而上层采用密度较小的网格状滤网，或者使上层滤网的滤丝分布较密，从而滤住较小的血栓。此外两层均可保留相当面积的血流通道，保证血流畅通。

Description

双层静脉滤器
技术领域
本发明属于生物医用材料中人体植入器械领域，具体地说涉及一种用于血管中，特别是腔静脉中血栓或其他块状物过滤和捕捉的装置。
背景技术
当人体静脉血流中的血栓或其它血管壁脱落物存在时，可经心脏进入肺动脉，造成肺动脉堵塞，从而导致死亡。滤器可将这些血栓捕获，并保留在腔静脉中，而后进行溶栓或取栓，从而防止上述危害发生。然而前期的滤器多采用单层结构，设计较疏松，只能滤住大块的血栓，较小的血栓可以通过，如将滤器作的较密，可滤住较小的血栓，但也有可能因为血栓的聚集将静脉血管堵塞。
发明内容
本发明的目的是制造出一种既可以保留适当面积的血流通道以保证血流畅通、又能有效过滤较小血栓的双层静脉滤器，以克服现有技术存在的上述缺陷。
本发明解决技术问题的技术方案如下：
一种双层静脉滤器，其特征在于，包括上下两层滤网，所述上下两层滤网之间通过设置在滤网中心的连杆相连，所述上层滤网和下层滤网均由若干根从滤网中心引出的单向并行的滤丝组成，所述滤丝呈菊花瓣状由滤网中心向四周发散，所述上层滤网的滤丝分布比下层滤网的滤丝分布密。
进一步，所述下层滤网的滤丝尾部设有向上弯折的钩刺，所述钩刺与滤网中心轴线的角度为20～100度，所述滤丝以滤网中心为圆心均布设置。
更进一步，所述上层滤网的滤丝呈圆弧状，滤丝尾部设有竖直段。
由以上公开的技术方案可知，本发明双层静脉滤器，通过设置两层滤网，使下层滤网的滤丝分布较疏，用于过滤较大的血栓；而上层采用密度较小的网格状滤网，或者使上层滤网的滤丝分布较密，从而滤住较小的血栓。此外两层均可保留相当面积的血流通道，保证血流畅通。本发明双层静脉滤器与前期同类产品相比较具有如下优点：
(1)疏密不同的双层过滤结构，使滤器将大块血栓滤在下层，小块的血栓留在了上层，从而滤住了较多的血栓而并不堵塞血管。
(2)滤器的双层结构与密层“花瓣”的圆弧尾部竖直段结构相配合，可保证滤器释放时候有很好的中心定位性能，使滤器植入血管后不会倾斜。
(3)疏层“花瓣”端部的钩刺可以使滤器较容易的刺入血管壁，防止滤器被血流冲走，同时钩刺的方向易于抽出，使滤器回收时最大限度的减少血管损伤。
(4)滤器下层花瓣茎上的台阶状设计，有利于滤器在输送器中的推送，使钩刺不会划伤血管壁；
(5)滤器的尾端钩子及整体的设计使其易于回收。
附图说明
图1是本发明双层静脉滤器结构示意图；
图2是图1中滤器植入血管时的工作状态示意图。
具体实施方式
下面结合附图与具体实施例进一步说明本发明。
如图1、图2所示，本发明双层静脉滤器，包括上下两层滤网1和2，所述上下峡谷层滤网1、2之间通过设置在滤网中心的连杆3相连，所述上述滤网1和下层滤网2均由若干根从滤网中心引出的单向并行的滤丝4和5组成，所述滤丝4和5呈菊花瓣状由滤网中心向四周发散，所述上层滤网的滤丝4分布比下层滤网的滤丝5分布密。本发明还可以上层滤网采用网格状结构，而下层滤网采用滤丝结构。
所述上层滤网的滤丝4为7～12根，所述下层滤网2的滤丝5为4～6根，所述滤丝以滤网中心为圆心均布设置。
所述滤器所采用的材料为NiTi形状记忆合金，利用其卓越的形状记忆效应和超弹性，从输送导管中释放出来的滤器能立即恢复其原有设计的形状，在血管中行使过滤血栓的功能。同时，NiTi合金具有良好的生物相容性和血液相容性，保证了使用过程中的安全性。滤器的制备可以通过将NiTi丝焊接起来，热处理定型而成；也可以将NiTi管经过激光切割，再热处理定型而成。这种滤器也可以用其他的医用弹性合金制成，如CoCr合金。
所述下层滤网的滤5尾部设有向上弯折的钩刺501，所述钩刺501与滤网中心轴线的角度α为20～100度。所述下层滤网2至少有三根滤丝5尾部设有钩刺501，所述带有钩刺的滤丝间隔设置。钩刺可以使滤器挂住血管壁，以防血流冲击下移位。所述下层滤网带有钩刺的滤丝在近钩刺501一段的丝体502呈台阶状，有利于滤器在输送器中的推送，使钩刺不会划伤血管壁。
所述上层滤网的滤丝4呈圆弧状，滤丝尾部设有竖直段401。
本发明还包括设置在滤器尾部的钩子6，其设置上层滤网外部中心处。可供回收时使用。
如图2本发明滤器植入血管7中的工作状态示意图所示，图中箭头方向为血流方向，使用时将上层滤网放置在血流方向的下游。临床使用时，本发明滤器须在X射线造影监视下使用。使用时将其从尾部压入插入血管内的塑料导管，塑料导管可以自显影或是头部带有X射线显影标记，以标示导管在人体血管内的部位。用推送杆将其推到导管的头部，而后固定推送杆，后撤导管，从而将滤器释放到血管中的制定部位。
实施例
用NiTi管激光切割制成a形滤器，疏层有六根腿，密层有十二根腿，外径为
Figure GSB00000211124400041
长度为40mm。在
Figure GSB00000211124400042
的模拟血管中试验，用生理盐水作血流，用血豆腐做成血栓，实施过滤。结果表明，疏端可滤住直径5mm以上的血栓，密端可滤住2.5～5mm的血栓，血栓存于中部，滤住后血流保持通畅。

Claims (8)

1.一种双层静脉滤器，其特征在于，包括上下两层滤网，所述上下两层滤网之间通过设置在滤网中心的连杆相连，所述上层滤网和下层滤网均由若干根从滤网中心引出的单向并行的滤丝组成，所述滤丝呈菊花瓣状由滤网中心向四周发散，所述上层滤网的滤丝分布比下层滤网的滤丝分布密。
2.根据权利要求1所述的双层静脉滤器，其特征在于，所述上层滤网的滤丝为7～12根，所述下层滤网的滤丝为4～6根，所述滤丝以滤网中心为圆心均布设置。
3.根据权利要求1所述的双层静脉滤器，其特征在于，所述滤器采用Nitinol形状记忆合金或医用CoCr合金制成。
4.根据权利要求1所述的双层静脉滤器，其特征在于，所述下层滤网的滤丝尾部设有向上弯折的钩刺，所述钩刺与滤网中心轴线的角度为20～100度。
5.根据权利要求2所述的双层静脉滤器，其特征在于，所述下层滤网至少有三根滤丝尾部设有钩刺，所述带有钩刺的滤丝间隔设置。
6.根据权利要求4所述的双层静脉滤器，其特征在于，所述下层滤网带有钩刺的滤丝在近钩刺一段的丝体呈台阶状。
7.根据权利要求1所述的双层静脉滤器，其特征在于，所述上层滤网的滤丝呈圆弧状，滤丝尾部设有竖直段。
8.根据权利要求1所述的双层静脉滤器，其特征在于，还包括设置在滤器尾部的钩子，其设置在上层滤网外部中心处。
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CN102973332B (zh) * 2012-11-23 2015-01-21 杭州启明医疗器械有限公司 血栓过滤器及其使用方法
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CN104352287B (zh) * 2014-10-13 2016-09-07 深圳市科奕顿生物医疗科技有限公司 腔静脉过滤器
CN105520791A (zh) * 2015-09-08 2016-04-27 上海宏普医疗器械有限公司 一种新型可回收腔静脉血栓过滤器
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CN107007377B (zh) * 2017-03-16 2019-09-10 杭州唯强医疗科技有限公司 多层过滤的腔静脉滤器
CN207821947U (zh) * 2017-04-11 2018-09-07 杭州唯强医疗科技有限公司 具有自中心性的腔静脉滤器
CN107280807A (zh) * 2017-06-28 2017-10-24 上海宏普医疗器械有限公司 一种半封闭双支撑可回收型腔静脉滤器
CN109567978A (zh) * 2017-09-29 2019-04-05 微创心脉医疗科技（上海）有限公司 滤器装置及其制造方法
CN110731832B (zh) * 2018-07-20 2022-04-12 上海微创医疗器械（集团）有限公司 下腔静脉滤器
CN109771088B (zh) * 2018-12-21 2021-12-03 先健科技(深圳)有限公司 滤器
CN109771089B (zh) * 2018-12-21 2021-11-16 先健科技(深圳)有限公司 滤器
CN109771092B (zh) * 2019-03-26 2019-11-12 李莹 一种腔静脉植入血栓过滤器
CN112137755A (zh) * 2019-06-28 2020-12-29 上海微创心脉医疗科技股份有限公司 滤器回收保护装置、滤器回收系统及方法、过滤系统
CN112206072A (zh) * 2019-11-14 2021-01-12 上海宏普医疗器械有限公司 一种可自适应血管弯曲的血栓过滤装置

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