CN104720936B - 使用安全的瓣膜支架以及具有该瓣膜支架的瓣膜置换装置 - Google Patents

使用安全的瓣膜支架以及具有该瓣膜支架的瓣膜置换装置 Download PDF

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CN104720936B
CN104720936B CN201510136304.5A CN201510136304A CN104720936B CN 104720936 B CN104720936 B CN 104720936B CN 201510136304 A CN201510136304 A CN 201510136304A CN 104720936 B CN104720936 B CN 104720936B
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valve
valve bracket
support
bar
support bar
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CN104720936A (zh
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曾敏
罗拉里
王云兵
齐均
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Hangzhou Qiming Medical Devices Co., Ltd.
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HANGZHOU QIMING MEDICAL DEVICE CO Ltd
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Priority to CN201510136304.5A priority Critical patent/CN104720936B/zh
Application filed by HANGZHOU QIMING MEDICAL DEVICE CO Ltd filed Critical HANGZHOU QIMING MEDICAL DEVICE CO Ltd
Priority to CN201710364207.0A priority patent/CN107157622B/zh
Priority to PCT/CN2015/078944 priority patent/WO2016149998A1/zh
Priority to KR1020177027319A priority patent/KR102393477B1/ko
Priority to MX2017012363A priority patent/MX2017012363A/es
Priority to EP21195080.3A priority patent/EP3957278A1/en
Priority to EP15885936.3A priority patent/EP3275404B1/en
Priority to BR112017020287-5A priority patent/BR112017020287B1/pt
Priority to JP2018500837A priority patent/JP6661746B2/ja
Priority to CA2985431A priority patent/CA2985431C/en
Priority to RU2017137520A priority patent/RU2703649C2/ru
Priority to ES15885936T priority patent/ES2901974T3/es
Publication of CN104720936A publication Critical patent/CN104720936A/zh
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Priority to US15/715,961 priority patent/US10537427B2/en
Priority to ZA2017/06879A priority patent/ZA201706879B/en
Priority to HK18103231.3A priority patent/HK1243622A1/zh
Priority to US29/719,480 priority patent/USD910852S1/en
Priority to US29/719,479 priority patent/USD977644S1/en
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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
    • A61F2/02—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
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436—Deployment by retracting a sheath
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • 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
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/001—Figure-8-shaped, e.g. hourglass-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
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • 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
    • A61F2230/0078—Quadric-shaped hyperboloidal
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0026—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in surface structures
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (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

本发明公开了一种使用安全的瓣膜支架以及具有该瓣膜支架的瓣膜置换装置，其中，瓣膜支架包括管状的支撑网架，以及连接在支撑网架端部的扩口段，所述扩口段与支撑网架上对应侧的所有端节点相连。所述扩口段处在瓣膜支架的先释放端。所述扩口段的外边缘由若干弯曲的支撑条围成，支撑网架上与支撑条位置相对应的端节点均与支撑条相连。本发明对现有的记忆合金自膨式瓣膜支架的结构进行改进，消除了瓣膜支架非端部部位出现的孤立存在的菱形顶点，在保持原有结构力学性能的同时，避免瓣膜支架压缩后出现尖刺，从根本上解决了尖刺导致的鞘管损坏问题。

Description

使用安全的瓣膜支架以及具有该瓣膜支架的瓣膜置换装置
技术领域
本发明涉及医疗器械领域，具体涉及一种使用安全的瓣膜支架以及具有该瓣膜支架的瓣膜置换装置。
背景技术
现有技术中，介入式心脏瓣膜通常包括可压缩的瓣膜支架和瓣叶，其中瓣膜支架具有良好的生物相容性，能够安全稳定可靠地放置在对应的心脏瓣膜位置。
瓣膜支架的主体部分多为菱形单元结构，以满足可压缩性的需求，但是，菱形单元结构会出现独立的菱形顶点，这些孤立存在的菱形顶点通常都比较尖锐，在瓣膜支架的使用过程中，这些孤立存在的菱形顶点有刺破鞘管的隐患。
若孤立存在的这些菱形顶点集中在瓣膜支架的端头部位，则刺破效应较小，但是为了适应心脏各个瓣膜的结构，不同部位的瓣膜支架的结构都有所不同。
以肺动脉瓣为例，为了使瓣膜在主肺动脉处的位置更加稳定，在瓣膜支架上增加了处在主肺动脉分支处的扩口，即将瓣膜支架端头部分的菱形进行了轴向上的延伸以及径向上的扩张，使该部位更加柔软，能够与血管壁形成弹性匹配，避免戳伤甚至戳破血管壁，但是，这种端头部位的结构改变会使瓣膜支架中菱形结构的某些孤立存在的顶点暴露出来。
例如，申请公开号为CN 102961199A的中国专利文献公开了一种防止移位的肺动脉瓣膜支架，包括瓣膜缝制段、连接在瓣膜缝制段上的人工瓣膜、以及与瓣膜缝制段远端相连接的限位机构，瓣膜缝制段释放后位于右室流出道或肺动脉主干上，限位机构的顶端部分释放后抵触肺动脉主干与支干的交汇处，以提供轴向限位功能。该专利文献中的瓣膜缝制段由若干菱形结构单元构成，瓣膜缝制段的远端与限位机构相连接时，遗留有若干孤立存在的菱形顶点，这些孤立存在的菱形顶点成为使用过程中的安全隐患。
又如，授权公告号为CN 101951858 B的中国专利文献公开了一种漏斗形节流装置，如图1所示，该漏斗形节流装置包括具有菱形网格结构的中部，以及连接在中部两端呈扩口状的端部，中部的菱形网格结构有若干孤立存在的菱形顶点10，这些孤立存在的菱形顶点10会对手术过程带来很大不便。
当瓣膜支架被压缩进鞘管后，孤立存在的菱形顶点会变形为尖刺，在通过人体复杂的弯曲解剖路径时，极易刺伤鞘管，在随后的瓣膜释放过程中，也会引起阻力过大，以及刺穿鞘管，导致瓣膜无法正常释放，极端情况下，会刺伤甚至刺穿血管壁，对病人造成极大的伤害。
发明内容
本发明提供了一种使用安全的瓣膜支架以及具有该瓣膜支架的瓣膜置换装置，消除了瓣膜支架非端部部位出现的孤立存在的菱形顶点，在保持原有结构力学性能的同时，避免瓣膜支架压缩后出现尖刺，从根本上解决了尖刺导致的鞘管损坏问题。
一种使用安全的瓣膜支架，包括管状的支撑网架，以及连接在支撑网架端部的扩口段，所述扩口段与支撑网架上对应侧的所有端节点相连。
本发明中的支撑网架是指瓣膜支架中用于支撑假体瓣膜的部分，通常为管状，血液在管状内部流动，与管状内部的假体瓣膜相作用。支撑网架并不限于是等径延伸的筒状，支撑网架的端部可以在径向上有膨胀或者收缩。
所述支撑网架的至少一端连接有扩口段，现有的瓣膜支架通常两端都固定有扩口段，这两个扩口段分别为流入段和流出段，流入段和流出段依据血液流动的方向来区分，即血液由流入段进入瓣膜支架，流经支撑网架后，由流出段离开瓣膜支架。
支撑网架具有菱形结构，支撑网架上的所有端节点，也即菱形邻近扩口段的所有顶点，将所有端节点与扩口段相连接，避免在瓣膜支架非端部的部位出现孤立的菱形顶点，消除了瓣膜支架压缩入鞘管后，出现尖刺的现象。
瓣膜支架由鞘管中先释放出来的一端为先释放端，将扩口段设置在先释放端，能够避免在鞘管回撤时，发生尖刺刺穿鞘管的现象。瓣膜支架的后释放端即使出现了尖刺，尖刺的朝向与鞘管回撤的方向一致，不容易出现尖刺刺穿鞘管的现象，因此，优选地，所述扩口段处在瓣膜支架的先释放端。现有技术中，通常流出段为先释放端，流出段即为所述的扩口段。
所述扩口段的外边缘由若干弯曲的支撑条围成，支撑网架上与支撑条位置相对应的端节点均与支撑条相连。所述端节点相交在支撑条上或通过接引条切入交汇连接至支撑条上。
将所有端节点直接连接或者通过接引条连接至支撑条上，即支撑网架上不存在孤立存在的端节点，每个端节点至少连接有三条线性边，在整个瓣膜支架发生压缩时，端节点不会变形为尖刺。
每根支撑条的两端分别连接支撑网架的一个端节点，支撑条的中部沿支撑网架的轴向延伸，且支撑条邻近端节点的部位向外弯曲以形成扩口。所述接引条由对应端节点至支撑条的延伸路径逐渐背离支撑网架。
接引条也具有适当的弯曲，且弯曲程度与支撑条的弯曲形状相适应，即接引条与支撑条位于同一光滑曲面上。
作为优选，延伸路径两端点连线与瓣膜支架轴线的夹角为0～70度。延伸路径与瓣膜支架轴线夹角为0度时，接引条的长度最短，但是，由于接引条以及支撑条均具有弯曲结构，因此，接引条的延伸路径通常不会与瓣膜支架的轴线相平行。接引条需要汇至支撑条上，为了配合支撑条的形状，接引条的延伸路径也不易与瓣膜支架的轴线具有很大的夹角。
优选地，延伸路径两端点连线与瓣膜支架轴线的夹角为20～60度。进一步优选，延伸路径两端点连线与瓣膜支架轴线的夹角为30～45度。
接引条与最邻近的支撑条相连接，接引条与支撑条相交部位的夹角为锐角。采用这种结构易于维持原有的力学性能。
每相邻的四个端节点作为一组，在一组端节点中，所述支撑条的两端分别与距离最远的两个端节点相连接，位于中部的两个端节点分别由一根接引条连接至对应侧的支撑条上，且两根接引条互不相交，每根接引条与支撑条相交的位置大致位于扩口段轴向上的中部。
所述支撑网架的其中一段为过渡段，该过渡段压缩前后的轴向长度之比等于1。过渡段在压缩前后保持轴向上长度不变，相比现有技术中通常采用的菱形网格，能够减小压缩前后在轴向上的长度变化。
作为优选，所述过渡段的轴向长度为支撑网架总长度的至少40％。只有在过渡段轴向长度与支撑网架总长度之比达到40％以上时，过渡段的作用才能够得以显现，即基于过渡段的存在，使压缩后的支撑网架的长度能够减小到满足弯曲顺应性的要求，使支撑网架能够顺利地到达人体内部预期部位，保证手术的顺利进行。
虽然过渡段能够减小支撑网架压缩前后轴向上的长度变化，但是，过渡段的长度也并非越长越好，因为，菱形网格虽然压缩前后在轴向上的长度变化比较大，但是菱形网格的结构能够保证支撑网架具有足够的强度，能够承受长时间的血液冲刷，且菱形网格的结构使支撑网架能够被压缩，从而放置在鞘管中。
因此，优选地，所述过渡段的轴向长度为支撑网架总长度的40～90％。进一步优选，所述过渡段的轴向长度为支撑网架总长度的50～80％。
作为最简单的实施方式，所述过渡段由若干沿瓣膜支架轴向延伸的直杆构成，各直杆沿周向均匀排布。
过渡段各直杆端头与对应的菱形顶点连接，过渡段各直杆端头连接在菱形网格朝向过渡段的菱形顶点。
本发明使用安全的瓣膜支架，技术方案容易实现，对现有的生产工艺以及生产效率基本不造成影响，只需要在瓣膜支架的激光切割步骤中采用修改过的图纸即可，不会增加生产成本，后续处理工艺以及模具都可沿用，产品改性成本低。
本发明还提供了一种瓣膜置换装置，包括所述的瓣膜支架，以及固定在所述支撑网架内部的假体瓣膜。
所述瓣膜支架的支撑网架和流入段均覆膜，假体瓣膜可缝制在瓣膜支架的内壁，也可以采用现有的其他方法进行安装固定。
本发明对现有的记忆合金自膨式瓣膜支架的结构进行改进，消除了瓣膜支架非端部部位出现的孤立存在的菱形顶点，在保持原有结构力学性能的同时，避免瓣膜支架压缩后出现尖刺，从根本上解决了尖刺导致的鞘管损坏问题。
附图说明
图1为现有技术中的瓣膜支架的示意图；
图2为现有技术中孤立端节点刺破鞘管的示意图；
图3为本发明使用安全的瓣膜支架的结构示意图(省略后半侧)；
图4为本发明使用安全的瓣膜支架的立体图；
图5为本发明使用安全的瓣膜支架的第二种实施方式的结构示意图(省略后半侧)。
图中：1、流出段；2、第二网格段；3、过渡段；4、第一网格段；5、流入段；6、支撑条；7、直杆；8、接引条；9、端节点；10、端节点；11、鞘管；12、支撑网架。
具体实施方式
下面结合附图，以肺动脉支架为例，对本发明做进一步阐释。
现有技术中的肺动脉支架中具有孤立存在的端节点，例如图1所示的肺动脉支架中存在端节点10，端节点10并非位于肺动脉支架的端部，在肺动脉支架被压缩入鞘管之后，孤立的端节点10容易变形为尖刺，在鞘管11回撤的过程中刺破鞘管11，如图2所示。
实施例1
如图3所示，使用安全的肺动脉支架，包括支撑网架12以及分别连接在支撑网架12轴向两端的流入段5和流出段1。
流入段5和流出段1的径向膨胀呈扩口，在人体内释放时，肺动脉支架的流出段1为先释放端，流出段1与支撑网架12上对应侧的所有端节点9相连。图3中省却了瓣膜支架的后半侧，仅显示瓣膜支架的前半侧。
流出段1的外边缘由若干弯曲的支撑条6围成，每相邻的四个端节点9作为一组，在一组端节点9中，具有一根支撑条6以及两根接引条8，支撑条6的两端分别与相距最远的两个端节点9相连接，位于中部的两个端节点9分别由一根接引条8连接至对应侧的支撑条6上，这两根接引条8互不相交，每根接引条8与支撑条6相交的位置大致位于流出段1轴向上的中部。
接引条8由对应端节点9至支撑条6的延伸路径逐渐背离支撑网架12，接引条8与支撑条6相交部位的夹角为锐角。接引条8的两端点连线与瓣膜支架轴线的夹角为30度。
实施例2
如图5所示，使用安全的肺动脉支架，包括支撑网架以及分别连接在支撑网架轴向两端的流入段5和流出段1，支撑网架的中部为过渡段3。
过渡段3的两端分别通过第一网格段4与流入段5相连接，通过第二网格段2与和流出段1相连接。第一网格段4和第二网格段2分别由连续的菱形组成，第一网格段4相比过渡段3，在径向上向外扩张形成扩口，菱形的边并非严格的直线，而是略向外弯曲，第一网格段4和第二网格段2的菱形数目相同。
过渡段3由若干沿瓣膜支架轴向延伸的直杆7构成，各直杆7沿周向均匀排布，过渡段3的轴向长度为支撑网架总长度的45％。
过渡段3各直杆7端头与对应的菱形顶点连接，过渡段3各直杆7端头连接在菱形网格朝向过渡段3的菱形顶点。由图5可以看出，过渡段3的各直杆7与相邻的菱形的边构成六边形，六边形的各内角均为钝角。
本发明采用自膨式瓣膜支架的设计结构，通过菱形网格段的变形实现瓣膜支架的收缩，使瓣膜支架能够压缩入鞘管中，同时在瓣膜支架植入人体后，能够产生均匀的径向支撑力，防止瓣膜移位和脱落，将孤立的端节点通过接引条连接至支撑条上，既可以排除端节点刺破鞘管的隐患，又不改变扩口段的血管顺应性。
除此之外，本发明的第二种实施方式可以将瓣膜支架所使用的金属材质(通常为记忆合金，本发明采用镍钛记忆合金)用量减少近一半，既可以降低瓣膜支架压缩后的直径，又能够改善弯曲顺应性，使瓣膜的通过性能得到进一步提升。
本发明提供的瓣膜置换装置，包括前述的瓣膜支架，以及固定在支撑网架内部的假体瓣膜。瓣膜支架通过输送系统进入人体预定位置后，瓣膜支架由鞘管中释放并膨胀，瓣膜支架内部固定的假体瓣膜替代人体内原有的瓣膜，实现使血液单向通过的功能。

Claims (3)

1.一种使用安全的瓣膜支架，包括管状的支撑网架，以及连接在支撑网架端部的流出段，其特征在于，所述流出段与支撑网架对应侧的所有端节点相连，所述流出段的外边缘由若干弯曲的支撑条围成，支撑网架上与支撑条位置相对应的端节点均与支撑条相连，支撑网架与流出段对应的端节点中，部分端节点相交在支撑条上，其余端节点通过接引条切入交汇连接至支撑条上；接引条与支撑条相交部位的夹角为锐角；
每根支撑条的两端分别连接支撑网架的一个端节点，支撑条邻近端节点的部位向外弯曲以形成扩口，接引条弯曲程度与支撑条的弯曲形状相适应；
所述接引条由对应端节点至支撑条的延伸路径逐渐背离支撑网架；延伸路径两端点连线与瓣膜支架轴线的夹角为20～70度；
将孤立的端节点通过接引条连接至支撑条上，既可以排除端节点刺破鞘管的隐患，又不改变扩口段的血管顺应性。
2.如权利要求1所述的使用安全的瓣膜支架，其特征在于，支撑网架的其中一段为过渡段，该过渡段压缩前后的轴向长度之比等于1。
3.一种肺动脉瓣膜置换装置，其特征在于，包括如权利要求1或2所述的瓣膜支架，以及固定在所述支撑网架内部的假体瓣膜。
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