CN111407466A - 一种可植入式生物瓣 - Google Patents

一种可植入式生物瓣 Download PDF

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CN111407466A
CN111407466A CN202010229521.XA CN202010229521A CN111407466A CN 111407466 A CN111407466 A CN 111407466A CN 202010229521 A CN202010229521 A CN 202010229521A CN 111407466 A CN111407466 A CN 111407466A
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valve
implantable
self
biological
expandable stent
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李传保
陈玉国
谷兴华
徐峰
赵鑫
张希全
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Qilu Hospital of Shandong University
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Qilu Hospital of Shandong University
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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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents 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
    • A61F2/91—Stents 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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014—Particular 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
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0061—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof swellable

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  • Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Optics & Photonics (AREA)
  • Physics & Mathematics (AREA)
  • Prostheses (AREA)

Abstract

本发明公开了一种可植入式生物瓣，包括：一可膨胀式支架，该支架内衬医用瓣膜。其瓣膜为四瓣膜，四瓣膜单向分流，十字对称分布。通过设计4瓣结构的生物瓣膜，在相同的血管截面面积上增加了分担反向血流的压力的瓣膜数量，从而降低了各瓣膜的受力大小。尤其是瓣膜片和瓣膜框架的结合处的应力大小。从而显著提高了生物瓣膜的使用寿命。可实施性强，显著提高了生物瓣膜的使用寿命。

Description

一种可植入式生物瓣
技术领域
本发明属于医疗器械技术领域，具体涉及一种可植入式生物瓣。
背景技术
公开该背景技术部分的信息仅仅旨在增加对本发明的总体背景的理解，而不必然被视为承认或以任何形式暗示该信息构成已经成为本领域一般技术人员所公知的现有技术。
各种瓣膜疾病占心血管病的很大比例，常用的解决办法是更换人工瓣膜。人工瓣膜根据使用的材料而分为两大类：一类是全部用人造材料制成的机械瓣；另一类是全部或部分用生物组织制成的生物瓣。机械瓣容易存在血栓栓率高，与抗凝有关的合并症以及长期存活率低等问题。
现有的三叶瓣的人工生物瓣膜一般是仿照人自身的主要瓣膜(如主动脉瓣)三瓣的结构进行设计。在使用过程中，血液流经时，流动的血液会对瓣膜起到一定的冲击作用，使瓣膜打开，而瓣膜打开的过程中会对瓣膜与支架连接结构的边缘起到一定的牵拉作用，如图1中的A、B和C中圈出的部位。血液流过后，瓣膜会合上。瓣膜合上后，会阻止血液的回流，血流会对整个瓣膜上施加一定的反向压力，该压力会传递至瓣膜与支架的连接位置。
所以，瓣膜在工作过程中会受到反复的正反向作用力，生物瓣膜在反复作用力下容易失效，尤其是图1中A、B和C中圈出的部位，更容易发生撕裂破坏，严重影响了生物瓣膜的使用寿命。
发明内容
为了解决现有技术中存在的技术问题，本发明的目的是提供一种可植入式生物瓣。
为了解决以上技术问题，本发明的一个或多个实施例提供的技术方案为：
一种可植入式生物瓣，其瓣膜为四瓣膜，四瓣膜单向分流，十字对称分布。
与现有技术相比，本发明的以上实施例的有益效果为：
通过设计4瓣结构的生物瓣膜，在相同的血管截面面积上增加了分担反向血流的压力的瓣膜数量，从而降低了各瓣膜的受力大小。尤其是瓣膜片和瓣膜框架的结合处的应力大小。从而显著提高了生物瓣膜的使用寿命。可实施性强，显著提高了生物瓣膜的使用寿命。
附图说明
构成本发明的一部分的说明书附图用来提供对本发明的进一步理解，本发明的示意性实施例及其说明用于解释本发明，并不构成对本发明的不当限定。
图1为现有技术中的三瓣膜结构示意图；
图2为本发明实施例的一种可植入式生物瓣侧视图结构示意图；
图3为本发明实施例的一种可植入式生物瓣主视图结构示意图。
其中，1、自膨胀式支架，2、瓣膜。
具体实施方式
应该指出，以下详细说明都是示例性的，旨在对本发明提供进一步的说明。除非另有指明，本文使用的所有技术和科学术语具有与本发明所属技术领域的普通技术人员通常理解的相同含义。
需要注意的是，这里所使用的术语仅是为了描述具体实施方式，而非意图限制根据本发明的示例性实施方式。如在这里所使用的，除非上下文另外明确指出，否则单数形式也意图包括复数形式，此外，还应当理解的是，当在本说明书中使用术语“包含”和/或“包括”时，其指明存在特征、步骤、操作、器件、组件和/或它们的组合。
一种可植入式生物瓣，其瓣膜为四瓣膜，四瓣膜单向分流，十字对称分布。
在相同的血管截面面积S,血流反向压强P,增加瓣膜数量N,则每片瓣膜会分担反向血流的压力F，F＝P*S/N。当增加瓣膜数量N,每片瓣膜分担的反向血流的压力F成反比降低。从而降低了各瓣膜的受力大小，尤其是瓣膜片和瓣膜框架的结合处的应力大小。从而显著提高了生物瓣膜的使用寿命。同时基于心血管医生的临床经验做出判断：瓣膜数量N取值不能无限大，太多的的瓣膜会使每片瓣膜占位面积减小，瓣膜开合动作幅度会减小，在临床会增加瓣膜内血栓的产生风险。而当瓣膜数量为4时，不但不会增加血栓风险，而且可以显著提高生物瓣膜的使用寿命。
在一些实施例中，所述瓣膜为生物瓣膜。
进一步的，所述瓣膜的材质为猪心包、牛心包或马心包。
在一些实施例中，所述可植入式生物瓣还包括自膨式支架。
进一步的，所述自膨式支架的材质为形状记忆材料或弹性材料。
更进一步的，所述自膨式支架的材质为镍钛记忆合金或钛钢合金。
再进一步的，所述自膨式支架采用形状记忆材料管一体雕刻制成。
实施例1
如图2和图3所示，一种可植入式生物瓣，包括自膨胀式支架1和四瓣膜2，自膨胀式支架1的材质为镍钛记忆合金，其由镍钛记忆合金管经过一体雕刻制成，该自膨胀式支架为两端稀疏、中间段密的网格结构，其具体形状为现有的可以实现的形状。四瓣膜的材质为猪心包。
以上所述仅为本发明的优选实施例而已，并不用于限制本发明，对于本领域的技术人员来说，本发明可以有各种更改和变化。凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。

Claims (9)

1.一种可植入式生物瓣，包括：一可膨胀式支架，该支架内衬医用瓣膜，其特征在于：其瓣膜为四瓣膜，四瓣膜单向分流，十字对称分布。
2.根据权利要求1所述的可植入式生物瓣，其特征在于：所述瓣膜为生物瓣膜。
3.根据权利要求2所述的可植入式生物瓣，其特征在于：所述瓣膜的材质为猪心包、牛心包或马心包。
4.根据权利要求1所述的可植入式生物瓣，其特征在于：所述可植入式生物瓣还包括自膨式支架。
5.根据权利要求4所述的可植入式生物瓣，其特征在于：所述自膨式支架的材质为形状记忆材料。
6.根据权利要求5所述的可植入式生物瓣，其特征在于：所述形状记忆材料为镍钛记忆合金。
7.根据权利要求4所述的可植入式生物瓣，其特征在于：所述自膨式支架的材质为弹性材料。
8.根据权利要求4所述的可植入式生物瓣，其特征在于：所述自膨式支架的材质为钛钢合金。
9.根据权利要求4所述的可植入式生物瓣，其特征在于：所述自膨式支架采用形状记忆材料管一体雕刻制成。
CN202010229521.XA 2020-03-27 2020-03-27 一种可植入式生物瓣 Pending CN111407466A (zh)

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* Cited by examiner, † Cited by third party
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CN1371666A (zh) * 2002-03-29 2002-10-02 中南大学湘雅二医院 弹性瓣环心包二尖瓣
US20070050021A1 (en) * 2005-08-25 2007-03-01 Derrick Johnson Four-leaflet stented mitral heart valve
CN201356678Y (zh) * 2009-01-16 2009-12-09 中国人民解放军第四军医大学 一种改良型人工生物心脏瓣膜
US20130261740A1 (en) * 2012-03-30 2013-10-03 Carol EBERHARDT Valve Prosthesis
CN103598939A (zh) * 2013-10-17 2014-02-26 杭州启明医疗器械有限公司 提高安全性的肺动脉支架及肺动脉瓣膜置换装置
US20170231756A1 (en) * 2016-02-05 2017-08-17 Edwards Lifesciences Corporation Devices and systems for docking a heart valve
US20170325944A1 (en) * 2016-05-13 2017-11-16 St. Jude Medical, Cardiology Division, Inc. Heart valve with stent having varying cell densities
CN107613907A (zh) * 2015-04-27 2018-01-19 杭州启明医疗器械有限公司 心脏瓣膜组件
US20180206982A1 (en) * 2017-01-23 2018-07-26 Edwards Lifesciences Corporation Covered prosthetic heart valve
CN109414321A (zh) * 2017-02-07 2019-03-01 上海甲悦医疗器械有限公司 治疗瓣膜反流的装置
CN109771097A (zh) * 2019-03-11 2019-05-21 北京航空航天大学 具有径向支撑力变化的人工介入型主动脉瓣膜支架
CN110433009A (zh) * 2018-05-03 2019-11-12 复旦大学附属中山医院 一种可回收球囊扩张介入性瓣膜及系统

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1371666A (zh) * 2002-03-29 2002-10-02 中南大学湘雅二医院 弹性瓣环心包二尖瓣
US20070050021A1 (en) * 2005-08-25 2007-03-01 Derrick Johnson Four-leaflet stented mitral heart valve
CN101262833A (zh) * 2005-08-25 2008-09-10 爱德华兹生命科学公司 四叶带支架的二尖瓣心脏瓣膜
CN201356678Y (zh) * 2009-01-16 2009-12-09 中国人民解放军第四军医大学 一种改良型人工生物心脏瓣膜
US20130261740A1 (en) * 2012-03-30 2013-10-03 Carol EBERHARDT Valve Prosthesis
CN103598939A (zh) * 2013-10-17 2014-02-26 杭州启明医疗器械有限公司 提高安全性的肺动脉支架及肺动脉瓣膜置换装置
CN107613907A (zh) * 2015-04-27 2018-01-19 杭州启明医疗器械有限公司 心脏瓣膜组件
US20170231756A1 (en) * 2016-02-05 2017-08-17 Edwards Lifesciences Corporation Devices and systems for docking a heart valve
US20170325944A1 (en) * 2016-05-13 2017-11-16 St. Jude Medical, Cardiology Division, Inc. Heart valve with stent having varying cell densities
US20180206982A1 (en) * 2017-01-23 2018-07-26 Edwards Lifesciences Corporation Covered prosthetic heart valve
CN109414321A (zh) * 2017-02-07 2019-03-01 上海甲悦医疗器械有限公司 治疗瓣膜反流的装置
CN110433009A (zh) * 2018-05-03 2019-11-12 复旦大学附属中山医院 一种可回收球囊扩张介入性瓣膜及系统
CN109771097A (zh) * 2019-03-11 2019-05-21 北京航空航天大学 具有径向支撑力变化的人工介入型主动脉瓣膜支架

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