CN101031258A - 瓣膜假体 - Google Patents

瓣膜假体 Download PDF

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CN101031258A
CN101031258A CNA2005800299493A CN200580029949A CN101031258A CN 101031258 A CN101031258 A CN 101031258A CN A2005800299493 A CNA2005800299493 A CN A2005800299493A CN 200580029949 A CN200580029949 A CN 200580029949A CN 101031258 A CN101031258 A CN 101031258A
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tubular support
bearing structure
valve prosthesis
valve
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CN100584293C (zh
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米科拉伊·维托尔德·斯蒂尔克
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Perouse Medical SAS
Cormove SAS
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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
    • 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
    • A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
    • 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
    • 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
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • 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
    • A61F2220/005—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using adhesives
    • 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
    • A61F2220/0058—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements soldered or brazed or welded
    • 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
    • A61F2230/0054—V-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

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

Abstract

本发明的瓣膜假体(10)包括柔性闸门(54)和环形承载结构(12)，所述承载结构是径向刚性的并且适合于被手术植入在心脏瓣膜的位置处。所述瓣膜假体设有可互换的人工瓣膜(50)，其独立于承载结构(12)，用于通过腔内途径安置就位；还包括管状支承件(52)，其可在适于被安置就位的收折位置和植入在承载结构中的展开位置之间径向变形。所述柔性闸门(54)连接着管状支承件(52)。所述承载结构(12)形成环形支承，其不带有用于限制血液仅向一个方向流动的闸门。

Description

瓣膜假体
技术领域
本发明涉及一种瓣膜假体，用于通过腔内途径而被安置就位，该假体包括柔性闸门和环形承载结构，该承载结构是径向刚性的，并且适合于被手术植入在心脏瓣膜的位置。
背景技术
心脏包括两个心房和两个心室，它们通过瓣膜而彼此分开。瓣膜还存在于右心室出口(肺动脉瓣膜)和左心室出口(主动脉瓣膜)。
这些瓣膜确保血液只沿一个方向流动，避免在心室收缩结束时血液回流。
瓣膜可能会产生疾病。特别地讲，它们会产生打开不良，从而降低血液流动，或者产生一定程度的泄漏，从而导致血液回流或逆流回到刚刚排出血液的心室。
这些逆流问题导致心室异常舒张，从而在长时间后引起心脏故障。
已知可以通过更换病变的瓣膜而手术处理这种疾病。病变的瓣膜，特别是左心室出口处的主动脉瓣膜被更换为取自死体的瓣膜，或更换为人工瓣膜，通常被称作生物假体瓣膜。人工瓣膜包括金属环结构和由动物源组织制成的柔性闸门。闸门永久性地固定至该金属环结构。
这样的瓣膜特别描述于文献WO01/03095和WO00/27975中。
一旦被植入，所述结构即支承于其被缝合的心脏内壁上，特别是在通向左心室主动脉瓣膜的入口处。
已经发现，在这样的假体已被植入了若干年后，其将退化并且不能再高效地发挥功能。特别地讲，柔性闸门可能被撕裂并存在孔洞，或者闸门钙化并因此而失去柔性，从而不再能够变形而执行其瓣膜功能。这就需要将新的假体安置就位。
然而，不能通过腔内路径取出旧的假体，特别地讲，由于假体承载结构被缝合在心脏的壁上，这意味着为完成瓣膜更换，只有通过大手术才能将承载结构分离。
为了避免通过大手术操作来取下旧的假体并将第二个假体安置就位，有人提出通过腔内途径将新的人工瓣膜安置就位于留在原位的旧假体内。
新的人工瓣膜由管状支承件形成，该管状支承件由装配有柔性闸门的径向可变形的栅格构成，该闸门设置在由管状支承件限定的通道中。闸门连接着管状支承件，并且其形状使得，通过变形，允许血液沿一个方向流动，并防止血液沿相反方向流动。
有人提出，管状支承件可以利用由交织的弹性金属线限定的网制成，所述网是大致菱形的。这样的管状支承件被称作″支架″。管状支承件可在直径缩小的插入位置和直径增大并且足以使得支承件支承于旧假体承载结构内的植入位置之间变形。
为了安置就位，这种包括管状栅格支承件的人工瓣膜布置在小直径导管内。导管的端部通过动脉网络被带到不再发挥功能的旧假体所被装配的区域。利用嵌在导管中的线状元件，新的人工瓣膜被从导管推出。由于管状支承件是弹性的，因此，在其不再被导管径向压缩时，其通过自身而立即展开。其将支承于旧假体承载结构的内周。
将新的瓣膜安置就位并将其展开是非常困难的操作，特别是当旧的假体的损坏很严重时。
发明内容
本发明的目的是提出一种瓣膜假体，其能够利用腔内途径而容易地恢复到适宜状态。
为此，本发明提供了一种上述类型的瓣膜假体，其特征在于，其包括：
可互换的(通用型)的人工瓣膜，其独立于承载结构，用于通过腔内途径而穿过所述环形承载结构安置就位，并且包括：
管状支承件，其可相对于主轴线在适于被安置就位的收折位置和植入在承载结构中的展开位置之间径向变形，在所述展开位置，管状支承件在其外周支承于承载结构上；
所述柔性闸门连接着管状支承件，并且可在横向伸出的阻挡位置和在流经管状支承件的血液的作用下横向收缩的释放位置之间变形；
其中，所述承载结构形成环形承载体，其不带有用于限制血液仅向一个方向流动的闸门。
在各个特定实施例中，瓣膜假体包括下述特征之一或多项：
所述管状支承件限定出不透液体的密实圆柱形壁；
所述管状支承件包括管状栅格，其覆盖于可撑展薄膜中，所述薄膜是不透液体的并且形成所述密实圆柱形壁；
还包括至少一个刚性元件，其大致沿着管状支承件的母线延伸，所述元件在沿着管状支承件的轴线相隔的至少两个点处连接着管状支承件；
管状支承件设有大致圆柱形的中间主干，以及两个大致截锥形的凸环部，它们沿轴向设在主干的各端，并从主干朝向支承件的端部张大；
管状支承件是弹性的，并且被成形为适于被从其收折位置朝向其展开位置弹性推动；
所述元件具有用于连接至支杆的突出端部，所述支杆用于将人工瓣膜保持就位；
管状支承件延伸为形成了三角架的会聚腿部，所述腿部在连接点处连接在一起，所述连接点基本上位于管状支承件的轴线上；
闸门包括三个膜元件，它们可在关闭位置和打开位置之间变形，在所述关闭位置，膜元件的自由边缘在它们的长度的一半上彼此成对地接触，在所述打开位置，所述三个膜元件彼此分开以便流过血液；
承载结构包括刚性环和一套刚性栓，每个栓从环开始平行于环的轴线延伸；
承载结构在其表面包括可实施缝合的织物片材。
本发明还提供了一种处理组件，其包括：
如前所述的瓣膜假体；和
用于将人工瓣膜安置就位的导管。
附图说明
通过下面结合附图而仅以示例的方式所做描述，本发明可以被更好地理解，在附图中：
图1是手术植入的瓣膜假体的承载结构本身的透视图；
图2是本发明的瓣膜假体处在其关闭状态时的透视图；
图3是图2所示瓣膜假体的端视图；
图4是与图3相同的视图，其中瓣膜假体处在打开状态；
图5和6是显示本发明的瓣膜假体的人工瓣膜安置就位时的顺序阶段的纵向剖视图；
图7和8是与图5和6相似的剖视图，显示了人工瓣膜从本发明的瓣膜假体撤回时的顺序阶段。
具体实施方式
在图1和2中，具有一个瓣膜假体(valve prosthesis)10，其完全显示于图2中，部分地显示于图1中。瓣膜假体可以用于心脏的主动脉瓣膜。因此，该假体在天然瓣膜的位置处被安置在主动脉的紧邻上游。
瓣膜假体包括承载结构12，其本身显示在图1中。该结构主要包括刚性环16，其承载着三个刚性栓18，它们分别从环开始平行于环16的轴线延伸。该环由刚性金属圆环体构成，所述三个栓18焊接在该圆环体上。该圆环体在其整个表面上被覆盖于纺织物片材20中，以使得通过将织物片材缝合在心脏壁上而将承载结构固定至心脏组织。环16的内径位于15mm至40mm的范围内。
每个栓18的一端固定至环16，所有这些栓向所述环的相同侧伸出。它们围绕承载结构12的轴线以一定角度规则分布。栓18的总高度，包括环16在内，位于10mm至30mm的范围内。
承载结构12不具有任何可在由该结构限定的空间内在关闭位置和打开位置之间变形的柔性闸门。
图2示出了本发明的已被植入的瓣膜假体10。除了承载结构12，瓣膜假体还包括人工瓣膜50，其可以通过腔内(endoluminal)途径而互换。在植入状态，人工瓣膜延伸在已经预先手术植入的承载结构12内侧。
人工瓣膜50包括具有轴线X-X的栅格管状支承件52和连接着管状支承件52并且设在其内侧的柔性闸门54。
瓣膜50是可更换的并且可以常规地相对于承载结构12拆下。
作为示例，管状支承件52由嵌入不透液体的可撑展薄膜52B例如弹性体中的管状栅格52A构成。由于薄膜52B覆盖栅格，因此其在支承件52的整个高度上限定出密实的不透液体圆柱形壁。栅格52A由具有弹性特性的不锈钢制成，从而使得支承件52是自膨胀的。这样的支承件，在其本身被使用时，通常被称作″支架″。
如图所示，支承件52可以自发地从具有小直径的压缩状态变形至具有增大直径的扩张状态，该扩张状态构成其静止状态。
在其植入状态，如显示于图2至4，由于其回弹性，支承件52支承于受损的瓣膜10的环16和栓18上，保持其三个膜元件26推压在支承件52外侧表面上。
在其每个轴向端部，支承件52以两个扩散的凸环部的形式轴向延伸超出承载结构，所述凸环部具有大致截锥形状，朝向支承件的轴向端部张大。
更确切地讲，支承件52具有大致圆柱形的中间主干62，其长度对应于承载结构的高度，该高度是沿着瓣膜的轴线测量的。主干的高度位于10mm至30mm的范围内。
限定主干62的栅格由交织金属线制成。因此，两组线相互交叉。第一组中的线构成沿同一方向定向并且大致相互平行延伸的螺旋线。第二组中的线构成沿不同方向定向并且相互平行延伸的螺旋线。第一和第二组中的线彼此上下相继地相嵌，从而使得各组的线限定出菱形网格，其中，每个网格的一条对角线延伸沿着支承件的轴线延伸，另一条对角线大致垂直地延伸。
在支承件的第一端，主干62延伸至喇叭口形凸环部64，其由一套凸角66构成，所述凸角沿着背离支承件轴线的方向朝向它们的弯曲末端延伸。这些凸角由形成在第一和第二组线的末端的线环形成，并且与所述线的末端形成一体。
类似地，在其另一端，支承件具有由主干62延伸的第二喇叭口形凸环部68。该凸环部类似地由向外变形的凸角70形成。
在静止状态，凸环部的自由端，即凸环部的最高喇叭口形端部，所限定出的外轮廓的直径等于主干62的直径加上5mm至15mm。
类似地，作为有益措施，沿着管状支承件52的轴线测量出的凸环部64、68的高度位于5mm至15mm的范围内，例如等于10mm。
嵌有管状栅格52A的薄膜52B延伸到形成凸环部64和68的凸角上。
在第一实施例中，当处在静止状态即未被压缩在结构12中时，管状支承件52在其整个高度内的直径大于结构12的直径，从而使得，当主干保持以管状形状限定在承载结构12中时，凸环部64和68仅仅由于管状支承件的自然回弹性而呈现为喇叭口形状。
在一个改型中，在静止状态，即使是没有压缩在结构12中，管状支承件的主干62的直径小于凸环部64和68的末端直径。
另外，分别从第一和第二组中伸出的三对线在凸环部68处成对地连接而形成三个腿部82。所述腿部沿着人工瓣膜轴线X-X彼此会聚，从而会合在位于所述轴线上的连接点84。所述三个腿部82因此限定出三角架。它们围绕轴线X-XI以一定角度规则分布，并且它们每个分别相对于所述轴线形成一个角度，该角度在20°至40°的范围内。出于连接的目的，所述三个腿部82被例如在点84处被拧结。连接线环形成在该末端点84。
此外，根据本发明，管状支承件52包括至少一个刚性元件90，其大致沿着管状支承件52的母线延伸。该元件在沿着支承件的轴线彼此相隔的至少两个点92A、92B处连接着支承件。所述两个点沿着主干62的高度形成，特别是在其与凸环部64和68相连的区域附近。连接可以通过焊接或粘结剂粘合等实现。
有益地，单一的元件90沿着主干62的一条母线形成。作为示例，该元件由纵向刚性金属线构成，该金属线嵌合在栅格的网格中，在栅格内侧和外侧交替地穿过。
有益地，该元件的端部布置在管状支承件内，即相对于不透液体薄膜52B位于轴线X-X旁边。
元件90的至少一个突出端部90A，特别是其靠近腿部82的端部，适于与支杆93协作以便与其轴向连接，如显示于图5，并且如下面所解释。支杆93和元件90之间的轴向连接是这样实现的，例如，该元件的连接端90A卡合在设置于支杆93的粗度内并且敞开在其一端的容置部中。
闸门54连接着管状支承件52的内表面。该闸门由三个柔性膜元件94A、94B和94C构成，每个膜元件由聚合物薄膜或一层有机薄膜例如犊牛心包(calf pericardium)形成。每个膜元件具有大致矩形形状。其围绕着主干62和扩大的凸环部64之间的连接周边沿着基部形成长边98连接着不透液体薄膜52B的内表面。
所述三个膜元件94A、94B和94C的纵向边缘99沿着三条母线连接着管状支承件52，所述母线围绕管状支承件的轴线以一定角度规则分布。因此，所述膜元件沿着它们的纵向边缘成对地连接着管状支承件。所述连接是在主干62的整个高度上实现的。
闸门形成膜元件94A、94B和94C可在图2和3所示的关闭位置与图4所示的用于流过血液的打开位置之间变形，在所述关闭位置，膜元件的自由边缘沿着它们长度的一半彼此成对地接触，而在所述打开位置，所述三个膜元件彼此分开。
在关闭位置，所述三个膜元件与支承件52的管状壁协作而限定出三个囊，以阻滞血流。在打开位置，所述三个膜元件被推压在管状支承件的内表面上，如显示于图4，因而一起限定出可以流过血流的大致圆形通道。
当瓣膜假体被初始安置就位后，医师开始以手术方式将承载结构12安置就位。为了这个目的，在患者胸部形成切口，承载结构12被放置到心脏处，在此被植入以占据原始瓣膜的位置。通过嵌入所述环的包覆织物20中的缝合线，承载结构12被固定至心脏壁。
在初始植入瓣膜假体的过程中，人工瓣膜50被手工安置就位在承载结构12内侧，然后，患者胸部被缝合。
所述结构12被永久性地植入患者体内，同时人工瓣膜50是可互换的。因此，在人工瓣膜50受损后，特别是由于膜元件钙化或撕裂，人工瓣膜通过腔内(endoluminal)途径被撤出，如下面所解释，并且新的人工瓣膜被安置就位在承载结构12所限定的空间中，如下面所解释。
为了将新的人工瓣膜50以腔内途径安置就位，图5和6所示的处理组件100被使用。其包括新的人工瓣膜50，它容纳在外径小于承载结构12内径的导管102中。
如显示于图5，人工瓣膜，特别是管状支承件52，被径向压缩在导管内。
此外，沿着导管102在长度方向延伸的支杆93在其端部连接至轴向刚硬的元件90的端部。支杆93具有足够的轴向刚度，从而能够将人工瓣膜从导管102中推出。
在安装瓣膜的过程中，容纳着人工瓣膜的导管端部102插入患者的主动脉中，然后沿着主动脉逐渐移动到心脏出口处受损人工瓣膜的位置。导管逆着血液的正常流动移动。
导管被带到图5所示的位置。在该位置，导管102被拉动，同时新的人工瓣膜50被支杆93保持位置。随着导管102移动，人工瓣膜50被解除覆盖，从而使得其端部展开而形成凸环部64，然后管状支承件主干62支承于栓18上，最终其另一端展开而形成凸环部68。
在通过移动导管102而逐渐裸露人工瓣膜50的过程中，人工瓣膜在轴向方向上相对于主动脉的管路保持静止，特别是借助于与保持元件90共线的刚性支杆93而相对于承载结构12留在原位。因此，设置与元件90协作的支杆93，可以降低人工瓣膜在被展开时轴向移动的危险，即使是在心跳引起血液流经瓣膜所在位置时进行展开的情况下。
由于设有扩大的凸环部64和68，它们分别支承于环16以及栓18的端部上，因此在展开后，瓣膜被轴向保持。
在展开后，支杆93仅仅通过牵拉而被撤出。因此，元件90脱离支杆93的端部。元件90由于与管状支承件52形成一体而保留在其位置。
如显示于图7和8，为了撤出受损的人工瓣膜50，导管112通过主动脉而被引入，并且被安置成面对着具有所述由腿部82形成的三角架的瓣膜端部。
牵引工具114被沿着导管112输送。在其端部，工具具有钩子116，其适于抓住所述三角架的连接点84f。在导管的敞开端与所述三角架的腿部82接触的情况下，通过导管112沿着瓣膜50的长度逐渐进给，人工瓣膜50被逐渐引入导管112内。利用凸轮式推压作用，腿部82被推向轴线，而人工瓣膜被逐渐移动到其张紧状态，并且插入导管112中，如显示于图8。容纳着人工瓣膜50的导管112随后被从人体撤出。
然后，利用用于在人体中实施处理的组件100，新的人工瓣膜50被引入，并且新的瓣膜被如前所述展开。
可以理解，利用这样的血管假体，只需要进行一次大手术操作来将承载结构12安置就位，之后，可以通过腔内途径定期更换人工瓣膜，这种操作对于患者而言是相对较轻的。
承载结构没有设置任何闸门形成元件，而只具有提供人工瓣膜的刚性支承表面的功能，因而可以获得令人满意且干净的支承表面，而不论人工瓣膜的状态如何。
相反，在由配备了闸门的支架形成的人工瓣膜被植入包括承载结构和闸门的受损人工瓣膜时，由于易钙化的闸门的存在，会影响新的人工瓣膜的安置就位。

Claims (10)

1.一种瓣膜假体(10)，包括：
柔性闸门(54)和环形承载结构(12)，所述承载结构是径向刚性的并且适合于被手术植入在心脏瓣膜的位置处；
所述瓣膜假体的特征在于，还包括：
可互换的人工瓣膜(50)，其独立于承载结构(12)，用于通过腔内途径而被穿过所述环形承载结构(12)安置就位，并且包括：
管状支承件(52)，其可相对于主轴线(X-X)在适于被安置就位的收折位置和植入在承载结构中的展开位置之间径向变形，在所述展开位置，管状支承件(52)在其外周支承于承载结构(12)上；
所述柔性闸门(54)连接着管状支承件(52)，并且可在横向伸出的阻挡位置和在流经管状支承件(52)的血液的作用下横向收缩的释放位置之间变形；
其中，所述承载结构(12)形成环形承载体，其不带有用于限制血液仅向一个方向流动的闸门；
所述管状支承件(52)限定出不透液体的密实圆柱形壁；
所述管状支承件(52)包括管状栅格(52A)，其覆盖于可撑展薄膜(52B)中，所述薄膜是不透液体的并且形成所述密实圆柱形壁。
2.根据权利要求1所述的瓣膜假体(10)，其特征在于，还包括至少一个刚性元件(90)，其大致沿着管状支承件(52)的母线延伸，所述元件(90)在沿着管状支承件(52)的轴线相隔的至少两个点(92A，92B)处连接着管状支承件(52)。
3.根据权利要求2所述的瓣膜假体(10)，其特征在于，所述元件(90)具有用于连接至支杆(93)的突出端部(90A)，所述支杆用于将人工瓣膜(10)保持就位。
4.根据任一前述权利要求所述的瓣膜假体(10)，其特征在于，管状支承件(52)设有大致圆柱形的中间主干(62)，以及两个大致截锥形的凸环部(66，70)，它们沿轴向设在主干(62)的各端，并从主干(62)朝向支承件(52)的端部张大。
5.根据任一前述权利要求所述的瓣膜假体(10)，其特征在于，管状支承件(52)是弹性的，并且被成形为适于被从其收折位置朝向其展开位置弹性推动。
6.根据任一前述权利要求所述的瓣膜假体(10)，其特征在于，管状支承件(50)延伸为形成了三角架的会聚腿部(82)，所述腿部在连接点(84)处连接在一起，所述连接点基本上位于管状支承件(52)的轴线(X-X)上。
7.根据任一前述权利要求所述的瓣膜假体(10)，其特征在于，闸门(50)包括三个膜元件(94A，94B，94C)，它们可在关闭位置和打开位置之间变形，在所述关闭位置，膜元件的自由边缘在它们的长度的一半上彼此成对地接触，在所述打开位置，所述三个膜元件彼此分开以便流过血液。
8.根据任一前述权利要求所述的瓣膜假体(10)，其特征在于，所述承载结构(12)包括刚性环(16)，其承载着一套刚性栓(18)，每个刚性栓分别从环(16)开始平行于环(16)的轴线延伸。
9.根据任一前述权利要求所述的瓣膜假体(10)，其特征在于，所述承载结构在其表面上包括用于实施缝合的纺织物片材(20)。
10.一种处理组件(100)，包括：
根据任一前述权利要求所述的瓣膜假体(12，50)；以及
导管(102)，其用于将人工瓣膜(50)安置就位。
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CN102665612A (zh) * 2009-11-05 2012-09-12 宾夕法尼亚大学理事会 瓣膜假体
CN102665612B (zh) * 2009-11-05 2015-04-08 宾夕法尼亚大学理事会 瓣膜假体

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BRPI0515637A (pt) 2008-07-29
FR2874813B1 (fr) 2007-06-22
WO2006027499A3 (fr) 2006-08-31
EP1786368B1 (fr) 2014-08-20
WO2006027499A2 (fr) 2006-03-16
EP1786368A2 (fr) 2007-05-23
US20080077234A1 (en) 2008-03-27
BRPI0515637B8 (pt) 2021-06-22
US7648528B2 (en) 2010-01-19
BRPI0515637B1 (pt) 2018-10-30

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