CN108135592B - 用于固定经导管瓣膜至生物假体心脏结构的间隔件 - Google Patents

用于固定经导管瓣膜至生物假体心脏结构的间隔件 Download PDF

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CN108135592B
CN108135592B CN201680060392.8A CN201680060392A CN108135592B CN 108135592 B CN108135592 B CN 108135592B CN 201680060392 A CN201680060392 A CN 201680060392A CN 108135592 B CN108135592 B CN 108135592B
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L·A·凯姆普贝尔
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Edwards Lifesciences Corp
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    • 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
    • A61F2/02—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
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    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
    • A61F2/2448—D-shaped rings
    • 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
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    • 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
    • A61F2/243—Deployment by mechanical expansion
    • A61F2/2433—Deployment by mechanical expansion using balloon catheter
    • 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
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/0054—V-shaped
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    • 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
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular
    • 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
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    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular
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    • 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
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
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Abstract

提供了用于生成经导管心脏瓣膜的对接站的间隔件。间隔件改变了植入的生物假体结构如生物假体心脏瓣膜或瓣环成形环的有效直径和/或形状，提供经导管瓣膜扩张至其中的支撑结构，而不过度扩张。间隔件可以经介入技术通过经中隔进入、经股进入或经心尖进入进行部署，并且一般在植入的生物假体结构的流入部分上至少部分地部署。

Description

用于固定经导管瓣膜至生物假体心脏结构的间隔件
技术领域
本公开涉及生物假体瓣膜或已用瓣环成形环修复的天然瓣膜中的经导管瓣膜植入，并且具体地，协助在生物假体瓣膜中固定经导管瓣膜或固定经导管瓣膜至瓣环成形环的设备和方法。
背景技术
瓣中瓣经导管瓣膜植入在生物假体心脏瓣膜失效时越来越多地使用。生物假体瓣膜比机械瓣膜更常使用，而且越来越多地用于年轻患者。虽然生物假体瓣膜的耐用性有所提高，但一些患者的生命超过了瓣膜的寿命，例如，当结构恶化导致瓣膜失效时。对于生物假体瓣膜置换的年轻人来说，存在重要的可能性，即在生命的后期需要另外的瓣膜置换。在这种置换中，新瓣膜可以是经导管瓣膜(THV)，所述经导管瓣膜(THV)置于现有的生物假体瓣膜内，而无需开心手术。
存在经导管瓣膜，其大小适合放置在大多数主动脉生物假体瓣膜内。然而，这种经导管瓣膜太小而不能固定至一些较大的生物假体瓣膜尺寸中。在较大的瓣膜中瓣中瓣置换的挑战是经导管瓣膜可能不够大以在植入组织瓣膜内充分扩张以保持在适当的位置并能够起作用。如果经导管瓣膜扩张过大，则瓣膜小叶可能不会适当地合在一起或接合(coapt)以使瓣膜正常工作。
类似地，可能需要将经导管瓣膜植入经瓣环成形带修复的天然瓣膜中。瓣膜成形术是修复瓣膜的技术。瓣环成形环被植入瓣环周围，将小叶拉到一起以促进天然瓣膜小叶的接合和适当的功能。瓣环成形环可以具有非圆形构造，例如D形(仅作为一个实例)，特别是当该环与二尖瓣结合使用时。根据本发明的间隔件可以适于固定至适当的瓣环成形环，以提供经导管心脏瓣膜可以扩张并固定其中的结构。
发明概述
在一个实施方式中，提供间隔件(其可以在本文中可选地称为THV对接站(dockingstation))用于植入生物假体心脏结构如生物假体心脏瓣膜或瓣环成形环，其具有中心流动轴、上游方向和下游方向。下游方向对应于在植入间隔件时来自生物假体结构的上游部分，并且通过心脏瓣膜的下游部分中的活瓣的血流的方向。间隔件具有经导管瓣膜安装表面。
就可以额外单独或彼此结合地使用的任选部件而言，间隔件可包括安装在生物假体结构的上游表面上的第一凸缘和间隔件轴。间隔件还可以任选地具有以相对于第一凸缘的下游方向安装在生物假体结构上的第二凸缘。在其中间隔件具有第一凸缘和第二凸缘两者的实施方式中，间隔件轴使第一凸缘和第二凸缘互相连接。作为另一个代替方案，间隔件可以具有固定至现存的生物假体结构的内表面的间隔件轴，而没有第一凸缘或第二凸缘。
第一凸缘可以任选地具有大于生物假体结构的第二凸缘和内径的尺寸的尺寸。第二凸缘可以任选地适应于相对于瓣膜小叶固定至生物假体结构的上游部分中的圆柱形空间的内径，所述瓣膜小叶位于相对于圆柱形空间的下游方向上。间隔件可以任选地包括刺突(spike)或其它本领域已知的附接装置，用于固定间隔件至生物假体心脏瓣膜。在一个实施方式中，第二凸缘包括这种刺突。
一方面，间隔件包括形状记忆材料并且是自扩张的，用于经导管递送至生物假体瓣膜中。可选地，间隔件的至少部分可以是可球囊扩张的。
就其它任选部件而言，间隔件可包括与其连接的圈套器(snare)以控制间隔件环在部署期间的扩张。间隔件的至少部分可以用织物或其它血液不可渗透的材料进行覆盖。间隔件可以包含，例如，钴铬合金、镍钛诺、不锈钢和/或其它本领域已知材料。第二凸缘可以适应于固定至生物假体结构的上游部分中的圆柱形空间中的加强带。第一凸缘和/或第二凸缘可以任选地是环。间隔件轴可以任选地大体上为圆柱形。在一个实施方式中，间隔件包括传递传感器数据的传感器。THV可以对接至其中的轴可以是弹簧加载的。THV可以对接至其中的轴包含可压缩的表面。
另一个方面是为经导管瓣膜在生物假体结构内提供固定表面的方法。结构具有带有上游方向和下游方向的中心流动轴，下游方向对应于在植入间隔件时来自生物假体结构的上游部分的血流通过结构的下游部分中的活瓣的方向。方法可包括为生物假体结构提供可折叠的间隔件，折叠间隔件至减小的直径，联接间隔件至细长导管的远端部分，推进细长导管通过患者的维管结构并且递送间隔件至相对于生物假体结构的适当位置中，和扩张间隔件以为经导管心脏瓣膜提供啮合(engagement)表面。
就可以额外单独或彼此结合地使用的方法的另外任选部件而言，方法可进一步包括扩张上游间隔件凸缘，使得上游间隔件凸缘的外部尺寸大于生物假体结构的上游端的内径。上游间隔件凸缘可以被定位成与生物假体结构的上游端表面接触，并且随后完成间隔件的扩张。间隔件可，例如，固定在生物假体结构内，间隔件的下游部分被定位在生物假体心脏瓣膜或天然心脏瓣膜的活瓣的上游。
在固定于生物假体结构内后，间隔件环可以具有安装在生物假体结构的上游表面上的上游凸缘，和向下游延伸并且朝向瓣膜活瓣的间隔件啮合表面。方法还可以包括在生物假体结构内扩张经导管心脏瓣膜，经导管心脏瓣膜固定至间隔件的表面。间隔件可以相继地从递送系统中推出，上游凸缘首先从递送系统中推出并且翻转成适当位置，上游凸缘被牵拉至瓣膜，并且推出间隔件的其余部分以完成间隔件的扩张。
当间隔件扩张时，间隔件上的刺突可以固定至植入的生物假体结构中，从而将间隔件保持在适当位置。作为一个实例，刺突可以固定至生物假体结构的内径中。在一个实施方式中，生物假体结构的内径用布、织物或其它覆盖物进行覆盖，并且将刺突固定至覆盖物中。另一个方面，间隔件可以具有下游凸缘，其中刺突延伸自下游凸缘，并且刺突固定至生物假体结构的内径中的步骤可包括在瓣膜的活瓣的上游固定延伸自下游凸缘的刺突至生物假体结构的内径中。
间隔件的扩张可以用可自扩张的间隔件完成。可选地，扩张间隔件的步骤可以至少部分地用球囊完成。在另外的任选部件中，方法可包括用联接至间隔件的圈套器控制间隔件的扩张的步骤。
在一个实施方式中，间隔件具有上游环凸缘并且方法包含将上游环凸缘与生物假体结构的上游部分衔接的步骤。间隔件可包括下游环凸缘，并且方法包括将下游环凸缘与生物假体结构的下游部分啮合的步骤。
此外，所公开的概念包括变化，并且可以酌情单独地或在合适时以各种组合将上述的任选部件添加至本发明的实施方式。
通过参考说明书和附图的其余部分，对本质和优点的进一步理解将变得明显。
附图简要说明
图1示例安装至生物假体二尖瓣、三尖瓣或主动脉瓣上的间隔件的实施方式；
图2是图1的间隔件的顶部视图；
图3是图1和2的间隔件的透视图；
图4是图3的间隔件环的横截面；
图5是示例加强环和覆盖物的手术生物假体瓣膜的一个实施方式的横截面；
图6是导管递送系统的横截面图，其中内侧具有准备部署至生物假体瓣膜上的自扩张间隔件环的一个非限制性实例；
图7示例图6的导管递送系统，其中推进器将间隔件的自扩张上环凸缘部分从递送系统中推出；
图8示例将扩张的上环凸缘部分牵拉至在生物假体瓣膜的上游部分上的适当位置；
图9是图8的系统，其中间隔件壁和下环凸缘扩张至适当位置并且下环凸缘上的刺突将间隔件固定至生物假体瓣膜内的织物中；
图10示例在植入间隔件环后递送系统被牵拉离开；
图11示例其中圈套器控制间隔件的扩张的可选实施方式；
图12示例其中间隔件具有上凸缘和间隔件，而无下游凸缘的可选实施方式，为简单起见支柱未示出；
图13以横截面示例图12的间隔件环；
图14是与瓣环成形环互相连接的间隔件的透视图；
图15是图14的瓣环成形环的顶部视图；
图16是图14和15的间隔件的透视图；
图17是在线17-17处取得的图16的间隔件的横截面；
图18是图14的间隔件的透视图，其中覆盖物被布置在其上；和
图19示例图18的间隔件，其中经导管心脏瓣膜在其中扩张。
发明内容
图1示例部署在手术二尖瓣或三尖瓣假体瓣膜10，例如，Carpentier-EdwardsPERIMOUNT Magna Mitral
Figure BDA0001629310440000041
二尖瓣心脏瓣膜(Model 7300TFX，EdwardsLifesciences，Irvine，CA)中的间隔件环5的一个实施方式。提供间隔件环5以变窄或减小经导管瓣膜被植入至其中的植入的生物假体二尖瓣、三尖瓣、肺动脉瓣或主动脉瓣10(例如，可手术植入的生物假体瓣膜)的空间。如上所述，间隔件环5可用于这样的情况，其中先前植入的假体瓣膜的内部空间或管腔过大而不能在其中直接植入最大可用的经导管瓣膜。图2是手术二尖瓣或三尖瓣瓣膜10上的处于适当位置的相同间隔件环5的顶部视图。图3是间隔件环自身的透视图，以及图4是图3的间隔件环的横截面。
就图4而言，间隔件具有上游侧上的第一环凸缘20、具有经导管心脏瓣膜可以固定至其的内表面的间隔件轴30、和具有锚件、倒钩或刺突50的下游较低环凸缘40。提供刺突50以将间隔件环固定至手术生物假体瓣膜的内部上的织物。注意，术语“上游”和“下游”结合其中生物假体瓣膜是例如间隔件要附接至其的生物假体结构的实施方式一起使用，并且在与间隔件附接至其的其它生物假体结构一起使用时，该术语可以简单地指代相对位置，而非严格地指代血液流动的方向。
图1和2示例在生物假体手术心脏瓣膜10上固定在适当位置的间隔件10。一旦间隔件处于适当位置，经导管瓣膜可以以与在其中不需要间隔件环的较小的手术瓣膜中将会完成的相同的方式安置在生物假体瓣膜中，其中经导管瓣膜啮合已被安置在生物假体瓣膜中的间隔件上的内表面。间隔件为经导管瓣膜提供轴向支撑，使得经导管瓣膜将不会在上游或下游方向上移动，并且为经导管瓣膜的外壁或支架提供径向支撑，从而减小过度扩张经导管瓣膜的风险。
图5是代表性手术生物假体主动脉瓣膜100诸如Carpentier-Edwards
Figure BDA0001629310440000042
主动脉心脏瓣膜(Model 2700TFX，Edwards Lifesciences)(仅作为一个实例)的横截面图。间隔件和方法还可适应于其它假体瓣膜，例如，具有其它结构细节的假体瓣膜，以及设计用于的其它天然瓣膜部位的假体瓣膜，其包括如上所述的肺动脉瓣、二尖瓣和三尖瓣假体瓣膜。如示，瓣膜100具有对应于血液流至瓣膜中的方向的流入方向。瓣膜还具有对应于当血液通过活瓣(小叶)离开瓣膜时血液流动的方向的流出方向。瓣膜包括支撑瓣膜小叶80的织物覆盖的支架部分。在瓣膜的流入侧是环形套箍。在瓣膜的内部是通常圆柱形空间120，其在图5的横截面图中示例，由示例的实施方式中的加强环125所支持。瓣膜的其它实施方式不包括加强环。内部用织物或本领域已知的其它覆盖物130进行覆盖。这可在瓣膜的流入部分上提供间隔件10(图1-4)安装至其上的而大体上不妨碍小叶80的操作(其可使组织瓣膜不起作用)的空间120。间隔件可以通过介入技术，例如，通过经中隔进入、经股进入或经心尖进入进行部署，并且一般部署在植入的生物假体瓣膜的流入端上或附近。可选地，间隔件可以手术地，例如，在微创手术(MIS)程序中进行部署。
将装置定位在跳动心脏内可能是困难的，例如，包括一个或多个挑战性步骤。图6是插入在动脉220内用于递送间隔件5'的导管210的横截面图。间隔件5'包括上游凸缘部分20'、间隔件表面部分30'和具有刺突50'的下游凸缘部分40'。推进器200向上游推动间隔件5'用以递送至现存的生物假体瓣膜10'上。在一个实施方式中，间隔件被部分地扩张，使得间隔件的上游凸缘的外径大于手术瓣膜的内径，如图7中所示。随后间隔件可以从图7中示例的心房位置牵拉至与植入的生物假体瓣膜接触(图8)，其中扩张将，例如，通过缩回导管210和/或调节推进器200的位置而被完成(图9)。在图10中，包括导管210和推进器200’的递送系统从间隔件5'和生物假体瓣膜10'牵拉离开。此方法允许在植入的瓣膜的流入方向上对齐间隔件，而不使手术瓣膜变得不起作用。通过此方法，间隔件可以是可球囊扩张的装置或受控的自扩张装置。如图1和2中所示，间隔件环的结构包括一系列支柱，最普遍地限定宝石形单元，但在替代方案中包括V形单元、矩形单元和/或本领域已知的其它单元形状，和其组合。间隔件可以通过其它球囊和/或本领域已知的机械扩张方法进行扩张。间隔件还可以部分地自扩张和部分地球囊扩张。仅作为一个实例，上游和/或下游凸缘可以自扩张，例如，而间隔件的中心部分被球囊扩张。完全自扩张实施方式还可以在初始部署后进行球囊扩张，例如，以确保间隔件完全扩张和/或使任何锚件就位(seat)。
更详细地就此过程而言，图6以横截面示例经导管递送系统内侧的自扩张间隔件组件5'。在示例的实施方式中，间隔件5'在导管210中处于递送配置，其中上游凸缘20'、间隔件轴30'和下游凸缘40'均通常纵向地延伸，并且其中上游凸缘20'和下游凸缘40'径向地压缩。在一些实施方式中，间隔件轴30'也径向地压缩。示例的实施方式还包括多个任选的啮合装置、啮合元件或锚件50'，所述啮合装置、啮合元件或锚件50'在其它实施方式中具有不同配置。当推进器200将间隔件组件5'从导管210推出时，上游凸缘20'首先从导管210的远端处的开口纵向地延伸，随后向下翻转或旋转成总体上水平或径向位置，如图6和7中所示。随后间隔件和导管向近端牵拉或缩回，使得间隔件接触瓣膜，并且在迫使间隔件5'从导管201离开，例如，通过利用推进器200缩回导管而同时防止间隔件5'向近端移动时，继续扩张间隔件(包括间隔件轴30'和下游环40')，如图8中所示出。随后下游环40'上的一系列刺突50'从纵向递送配置翻转至径向部署配置，而下游环40'也如此。在图9中示例的实施方式中，向远方迫使推进器200，例如，将下游环40'迫使成最终部署配置和/或迫使锚件或刺突50'至在植入的生物假体瓣膜10'的内径周围布置的织物中，以在适当位置保持和固定间隔件。当间隔件从递送系统推出时，刺突50'延伸穿过手术瓣膜的内径并且进入手术瓣膜的织物。作为替代方案，可以部署凸缘20’和40’以夹持结构10’，从而将间隔件保持在适当位置。
在优选实施方式中，上游和下游凸缘和间隔件轴在平面视图上是环形的。但是，注意，凸缘和间隔件轴可以采取除了环之外的其它形式。进一步，上游和下游凸缘和间隔件轴可以彼此具有不同平面、横截面几何形状，只要其在间隔件组件中服务其各自的目的。
图11示例，在可选实施方式中，间隔件在离开递送系统后的扩张可以由圈套器240进行控制。圈套器240可以是缝合材料或金属线的圈，例如，或另一种适合的设计。在一个方法中，圈套器240通过推进器200'中的通道向上延伸。当圈套器240保持相对紧张的张力时间隔件5'的扩张随后被控制，然后以受控的方式，例如，逐步地，释放张力，直到间隔件5'处于适当位置，或以在给定的情况中适当的任何方式释放张力。
在一些生物假体瓣膜(例如，由Edwards Lifesciences生产和提供的某些生物假体瓣膜)中，瓣膜具有加强环125，如图5中所示例的。加强环125一般是织物覆盖的或以其它方式覆盖的环，所述环优选地由钴铬合金(例如，
Figure BDA0001629310440000061
合金，Elgiloy SpecialtyMetals,Elgin,IL)制成，所述加强环125在假体瓣膜的流入方向周围延伸，尽管加强环可包括其它材料，例如，不锈钢、镍钛诺、钴-铬和聚合物的任意组合。加强环125使假体瓣膜稳定和强化。如图10中所示，例如，间隔件部分和下环的长度足够短，以便确保间隔件环的刺突部分不延伸至瓣膜的小叶中或接触瓣膜的小叶，而宁可与流入方向上的加强元件上的织物覆盖物120啮合。
在间隔件的可选实施方式中，由织物或适合材料制成的覆盖物可以安置在间隔件自身上或安置在其部分上。在优选实施方式中，间隔件不具有覆盖物，因为覆盖物可以增加间隔件的成本和/或增加其递送轮廓。而且，因为众多经导管瓣膜不具有织物覆盖物，所以布置在间隔件上的覆盖物将不具有益处。另一方面，作为替代方案，间隔件装置上的覆盖物可以促进纤维组织过度生长以及间隔件并入经导管瓣膜和手术瓣膜，和/或减小植入的经导管瓣膜周围的瓣周漏。
图12示例了可选实施方式，其中间隔件具有上游凸缘320和间隔件轴330，但是在间隔件330下方不具有下游环。图13是图12的间隔件的横截面图，为易于示例其两者均不显示支柱，尽管环正常来说会具有如图1和2中的支柱。图12的间隔件可以与锚件或刺突350进行固定，例如，布置在上游凸缘320的下表面或流出表面上，和/或布置在如所示的间隔件轴330的外壁上。
在可球囊扩张的间隔件环的实施方式中，间隔件优选地由与经导管瓣膜和/或与假体手术瓣膜在电势序方面较接近的材料制成。以此方式，经导管瓣膜的金属部分、间隔件的金属部分和/或假体手术瓣膜的金属部分(例如，经导管瓣膜的接触间隔件轴的支架，或假体手术瓣膜的接触间隔件的锚件的带)之间不存在应力腐蚀问题。例如，间隔件环可以由不锈钢合金、钛合金、镍钛诺或钴铬合金中的一种或多种制成，其取决于经导管瓣膜的材料。钴-铬与镍钛诺具有类似的氧化电势，并且因此钴-铬是用于与包括镍钛诺框架的经导管瓣膜一起使用的优选材料。钴-铬间隔件环随后可以与例如，在支架或框架中包括镍钛诺和/或钴-铬的经导管瓣膜一起使用，以避免腐蚀问题。
根据本发明的间隔件环可以用于提供对接件(dock)，所述对接件固定至瓣环成形环，如具有钛核心和织物覆盖物的
Figure BDA0001629310440000062
Classic Annuloplasty Ring(EdwardsLifesciences,Irvine,CA)，或多种其它瓣环成形环中的任意一种。瓣环成形环使瓣环重新定型，使得天然瓣膜小叶可以适当地接合。然而，天然瓣膜最终可能需要用例如，经导管心脏瓣膜置换。固定至瓣环成形环的间隔件结构可以提供适合用于THV扩张进入和锚定的对接区域。附图示例了示例性D型瓣环成形环，尽管间隔件还可应用于其它形状的环，包括开环或带，以及可应用于刚性或挠性环。间隔件的实施方式可应用于二尖瓣和三尖瓣瓣环成形环两者。在一些实施方式中，间隔件在开环的打开部分处提供结构，其限制THV扩张，例如，抵靠左心室道(左心室流出道，LVOT)，从而减小此种情况中的LVOT阻塞的可能性。如同以上描述和示例的间隔件的实施方式，瓣环成形环间隔件的实施方式具有纵向或垂直轮廓，其在THV部署于其中之前，当间隔件啮合至瓣环成形环时，允许天然小叶保持起作用。
图14和15示例了固定至通常为D形的瓣环成形环410的间隔件405。瓣环成形环410包括中心打开的圆柱形轴415、上凸缘420、THV可以扩张和锚定至其上的圆柱形轴内的表面430、和下凸缘440。上凸缘和下凸缘的弯曲骨架(armature)具有选定的长度以适应于瓣环成形环410的形状。瓣环成形环410一般用织物覆盖物进行覆盖，并且刺突450从下凸缘440延伸进入织物，以有助于将间隔件405固定至瓣环成形环410。间隔件的上凸缘420一般抵靠瓣环成形环的上表面并且可任选地用刺突或其它附接装置固定至瓣环成形环的织物覆盖物。图16和17单独地示例了扩张的间隔件405。
间隔件可以以图6-9中示例的方式固定至瓣环成形环。如同一些其它实施方式，圈套器可以用于在部署期间控制间隔件环的扩张。可选地，可以部署第二凸缘使得瓣环成形环夹持在第一凸缘和第二凸缘之间。
从另一个角度看，对接站的一个实施方式被设计以在近端流入区段处密封，从而产生用于血液流动的导管并且防止心包渗漏。但是，远端流出区段通常保持打开。在一个具体实施方式中，布如例如聚对苯二甲酸乙二醇酯(PET)布，或其它材料覆盖近端流入区段，但覆盖物不覆盖远端流出区段的至少部分。布中的开口足够小，以显著阻止血液经其通过。而且，可以使用多种其它生物相容性覆盖材料，如，例如，用对血液不可渗透的涂层处理的织物、聚酯、聚四氟乙烯织物(PTFE，例如，ePTFE)、处理的生物材料，如心包膜、或本领域已知的其它覆盖物。间隔件环可以可选地被完全覆盖，或仅在选择区域进行覆盖。当THV固定至其的表面被覆盖时，覆盖物可以协助生成紧密密封和/或改善与THV的啮合。
另一个方面，间隔件环的内径保持在THV的操作范围内。因此，THV可以在一定空间内进行操作，否则该空间对于THV将太宽而不能适当地操作，和/或可以在一定空间中进行操作，否则该空间将不允许THV可靠地固定，例如，附图中示例的D形开口。
如前所述，间隔件可自扩张或球囊扩张。在球囊扩张的实施方式中，使一个或多个球囊膨胀以扩张间隔件。移除球囊，并且将THV递送和扩张至间隔件的中心轴中。可以利用本领域已知的扩张的其它方法。例如，在递送前间隔件环可以与THV捆绑在一起，其中间隔件环和THV均在单一递送中进行递送和扩张。
在另一个实施方式中，间隔件可包括传感器，如压力传感器。作为传感器的一种用途，对接站抵靠血管壁的压力可以在部署期间进行检测。传感器可以通过例如递送导管传递传感器数据。在球囊扩张期间使用数据，例如，以测定何时已经达到视情况而定的抵靠血管壁、手术瓣膜和/或瓣环成形环的足够压力，使得进一步扩张是不必要的。当在对接站扩张之前，血管壁的尺寸、弹性和/或其它变量不确定时，此方法可能是有用的。
另一个方面，间隔件的外表面可以通过正压进行固定。THV被扩张至环的内表面中。内环可以是“弹簧加载的”以保持抵靠THV的力，从而将THV保持在适当位置。内环表面和外环表面之间的支架结构可以提供弹簧加载。可选地，弹簧样机构可以构建至内环表面和外环表面之间的空间中。
在其它替代方案中，内环充当THV对接至其中的着陆区(landing zone)。内环可以具有柔软或可压缩的内表面，如泡沫、弹性聚合物、水凝胶或其它适合的生物相容性材料。在扩张的THV的力下内表面可能退让。环的内表面和外表面之间的区域可以如用织物覆盖物或位于环的内表面上的裙边进行密封，或者另外具有防止THV周围血液旁路的表面。注意，如本文使用的“环”包括横截面并非圆形的形状，如例如符合D形或其它形状的外环，以便将外环固定至支撑结构。
鉴于可以应用所公开的原理的多个可能的实施方式，应当认识到，示例的实施方式仅是优选实例，并且不应被视为限制本公开的范围。相反，范围由以下权利要求限定。因此，我们要求属于这些权利要求范围和精神内的一切权利。

Claims (19)

1.间隔件，所述间隔件用于植入围绕天然瓣膜的生物假体心脏结构中，其包含：
中心流动轴，所述中心流动轴具有上游方向和下游方向，所述下游方向对应于在植入所述间隔件时，来自所述生物假体心脏结构的上游部分的血流通过所述天然瓣膜的下游部分中的小叶的方向；
所述间隔件配置以经皮递送并且与所述生物假体结构可啮合，所述间隔件具有间隔件轴，所述间隔件轴提供经导管瓣膜安装表面；
其中所述间隔件轴使第一凸缘和第二凸缘互相连接，所述第一凸缘适于安装在所述生物假体结构的上游表面上，所述第二凸缘适于在所述第一凸缘的下游固定至所述生物假体结构的内径。
2.权利要求1所述的间隔件，其中所述第一凸缘具有大于所述第二凸缘和所述生物假体心脏结构的内径的尺寸。
3.权利要求1或权利要求2所述的间隔件，其中所述间隔件包含固定所述间隔件至所述生物假体心脏瓣膜的锚件。
4.权利要求3所述的间隔件，其中所述第二凸缘包含所述锚件。
5.权利要求1或权利要求2所述的间隔件，其中所述间隔件包含形状记忆材料并且是自扩张的。
6.权利要求1或权利要求2所述的间隔件，其中所述间隔件的至少部分是可球囊扩张的。
7.权利要求1或权利要求2所述的间隔件，其中所述间隔件包括与其连接的圈套器以控制所述间隔件的扩张。
8.权利要求1或权利要求2所述的间隔件，其中所述间隔件的至少部分用织物进行覆盖。
9.权利要求1或权利要求2所述的间隔件，其中所述间隔件包含钴铬合金。
10.权利要求1或权利要求2所述的间隔件，其中所述间隔件的部分适应于固定至所述生物假体心脏结构中的圆柱形空间中的加强带。
11.权利要求1或权利要求2所述的间隔件，其中所述间隔件轴大体上是圆柱形的。
12.权利要求1或权利要求2所述的间隔件，其中所述第二凸缘是环。
13.权利要求1或权利要求2所述的间隔件，其中所述第一凸缘是环。
14.权利要求13所述的间隔件，其中所述第一凸缘是具有非环形配置的环，以适应于所述生物假体心脏结构的非环形部分。
15.权利要求1或权利要求2所述的间隔件，其中所述间隔件包含传递传感器数据的传感器。
16.权利要求1或权利要求2所述的间隔件，其中THV可以对接至其中的轴是弹簧加载的。
17.权利要求1或权利要求2所述的间隔件，其中THV可以对接至其中的轴包含可压缩的表面。
18.权利要求1或权利要求2所述的间隔件，其中所述生物假体心脏结构是假体心脏瓣膜。
19.权利要求1或权利要求2所述的间隔件，其中所述生物假体心脏结构是瓣环成形环。
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