MODULAR PERCUTANEOUS VALVE STRUCTURE AND DELIVERY DEVICE

    公开(公告)号:EP3269331A1

    公开(公告)日:2018-01-17

    申请号:EP17187962.0

    申请日:2010-01-13

    IPC分类号: A61F2/24

    摘要: A modular prosthetic valve device for implantation in a patient is disclosed. The valve device is designed as two or more modules to be delivered unassembled and combined into an assembled valve device in the body - e.g., in the body at or near the site where implantation occurs. The two or more modules may be a support structure and a valve assembly. The valve assembly may be formed from two or more valve sections. Because the valve device of the invention is deliverable as modules, it may have a smaller delivery diameter than pre-assembled percutaneous valves and permits use of a delivery device of reduced diameter. Delivering the valve device as modules increases the flexibility of the valve device during delivery, compared to percutaneous valve devices in the art. The invention further provides a system for and method of delivering such a modular valve device and assembling it in vivo. The modules of the valve device may be connected by pull wires for delivery sequentially to or near the implantation site in the body lumen, and then assembled by remote manipulation using the pull wires. The system may further include a temporary valve that may be deployed to maintain valvular function while the device modules are assembled. The temporary valve may be attached to the delivery device and deployed either before or after the support structure is expanded, or the temporary valve may be attached to the support structure and deployed when the support structure is expanded. Various locking mechanisms are provided for attaching the device modules together.

    SELF-ASSEMBLING MODULAR PERCUTANEOUS VALVE AND METHODS OF FOLDING, ASSEMBLY AND DELIVERY
    5.
    发明公开
    SELF-ASSEMBLING MODULAR PERCUTANEOUS VALVE AND METHODS OF FOLDING, ASSEMBLY AND DELIVERY 审中-公开
    自组装模块化经皮瓣膜及折叠,组装和递送方法

    公开(公告)号:EP3111890A3

    公开(公告)日:2017-02-08

    申请号:EP16183064.1

    申请日:2010-01-13

    IPC分类号: A61F2/24

    摘要: The present invention provides a modular prosthetic valve device designed as two or more device modules that may be delivered to a body lumen unassembled and then assembled into the assembled valve device in the body at least in part using a self-assembly member at or near the site of valve implantation. The device modules may include a support structure and a valve module. The valve module may be delivered in an unassembled, folded delivery configuration, and unfolded and assembled into a working configuration via the self-assembly member. In its unassembled form, the valve module may be a single-piece leaflets substructure or a plurality of valve sections. The self-assembly member has a delivery configuration and a preset configuration, and may be triggered to revert to the preset configuration to assemble the valve module. The modular valve device may be folded in a manner not possible with current valve devices, for example, by rolling the unassembled valve module along its circumferential axis in the direction of its height, so that the diameter of the folded valve module may be equivalent to that of one rolled leaflet. This feature of the invention provides a percutaneous valve device having a smaller delivery diameter than pre-assembled valve devices. This in turn permits use of a delivery device of reduced diameter and increases the flexibility of the loaded delivery device compared to percutaneous valve devices in the art. The invention further provides a system for and method of folding and delivering such a modular valve device and assembling it using the self-assembly member, preferably in the body.

    摘要翻译: 本发明提供了一种模块化假体瓣膜装置,其被设计为两个或更多个装置模块,所述装置模块可被输送到未组装的体腔,然后至少部分地使用位于或靠近 瓣膜植入部位。 装置模块可以包括支撑结构和阀模块。 阀模块可以以未组装,折叠的输送构造输送,并且通过自组装构件展开并组装成工作构型。 在其未组装形式中,阀模块可以是单件小叶子结构或多个阀部分。 自组装构件具有递送配置和预设配置,并且可被触发以恢复到预设配置以组装阀模块。 模块化阀装置可以用当前的阀装置不可能的方式折叠,例如通过沿其高度方向将未组装的阀模块沿其周向轴线滚动,使得折叠的阀模块的直径可以等于 一张滚动的传单。 本发明的这个特征提供了一种经皮瓣膜装置,其具有比预先组装的瓣膜装置更小的输送直径。 这又允许使用与本领域中的经皮瓣膜装置相比直径减小的递送装置并增加装载的递送装置的灵活性。 本发明进一步提供了一种用于折叠和输送这种模块化阀装置并使用自组装元件将其组装的系统和方法,所述自组装元件优选在体内。

    SELF-ASSEMBLING MODULAR PERCUTANEOUS VALVE AND METHODS OF FOLDING, ASSEMBLY AND DELIVERY

    公开(公告)号:EP3111890A2

    公开(公告)日:2017-01-04

    申请号:EP16183064.1

    申请日:2010-01-13

    IPC分类号: A61F2/24

    摘要: The present invention provides a modular prosthetic valve device designed as two or more device modules that may be delivered to a body lumen unassembled and then assembled into the assembled valve device in the body at least in part using a self-assembly member at or near the site of valve implantation. The device modules may include a support structure and a valve module. The valve module may be delivered in an unassembled, folded delivery configuration, and unfolded and assembled into a working configuration via the self-assembly member. In its unassembled form, the valve module may be a single-piece leaflets substructure or a plurality of valve sections. The self-assembly member has a delivery configuration and a preset configuration, and may be triggered to revert to the preset configuration to assemble the valve module. The modular valve device may be folded in a manner not possible with current valve devices, for example, by rolling the unassembled valve module along its circumferential axis in the direction of its height, so that the diameter of the folded valve module may be equivalent to that of one rolled leaflet. This feature of the invention provides a percutaneous valve device having a smaller delivery diameter than pre-assembled valve devices. This in turn permits use of a delivery device of reduced diameter and increases the flexibility of the loaded delivery device compared to percutaneous valve devices in the art. The invention further provides a system for and method of folding and delivering such a modular valve device and assembling it using the self-assembly member, preferably in the body.

    SYSTEM FOR PLACING A PERCUTANEOUS VALVE DEVICE
    7.
    发明授权
    SYSTEM FOR PLACING A PERCUTANEOUS VALVE DEVICE 有权
    系统ZUR PLATZIERUNG EINER PERKUTANEN KLAPPENVORRICHTUNG

    公开(公告)号:EP2379012B1

    公开(公告)日:2016-08-03

    申请号:EP10702733.6

    申请日:2010-01-13

    IPC分类号: A61F2/24

    摘要: A system and process for placing a percutaneous valve device in a body lumen at the location of implantation is provided, which enhances the accuracy of the placement. Anchors and placement wires are used to fix the implantation target and guide the device to the implantation site. The system and method are applicable to preassembled percutaneous valve devices as well as a modular prosthetic valve device. The modular valve device comprises two or more device modules and is designed to be delivered unassembled and then assembled in the body lumen at or near the site where implantation occurs. The device modules may be assembled before or after the implantation target is fixed with the anchor, and then placed using the placement system in a manner similar to how a preassembled percutaneous valve device may be placed in accordance with the invention.

    摘要翻译: 提供了一种用于将经皮瓣膜装置置于植入位置的体腔内的系统和方法。 放置系统和方法简单,提高了阀门装置的放置精度。 使用锚杆和放置线或缝合线来固定植入目标并将装置引导到植入部位。 该系统和方法适用于预先组装的经皮瓣膜装置以及还提供了模块化装置的模块化假体瓣膜装置。 模块化阀装置包括两个或更多个装置模块,并且被设计成未被组装地输送,然后在植入发生的位置处或附近组装在体腔中。 装置模块可以在植入对象与锚固件固定之前或之后组装,然后以与根据本发明的预先组装的经皮瓣膜装置的放置方式类似的方式放置在放置系统中。

    SYSTEM AND METHOD FOR PLACING A PERCUTANEOUS VALVE DEVICE
    8.
    发明公开
    SYSTEM AND METHOD FOR PLACING A PERCUTANEOUS VALVE DEVICE 有权
    系统用于放置经皮片装置

    公开(公告)号:EP2379012A1

    公开(公告)日:2011-10-26

    申请号:EP10702733.6

    申请日:2010-01-13

    申请人: Valve Medical Ltd

    IPC分类号: A61F2/24

    摘要: A system and process for placing a percutaneous valve device in a body lumen at the location of implantation is provided, which enhances the accuracy of the placement. Anchors and placement wires are used to fix the implantation target and guide the device to the implantation site. The system and method are applicable to preassembled percutaneous valve devices as well as a modular prosthetic valve device. The modular valve device comprises two or more device modules and is designed to be delivered unassembled and then assembled in the body lumen at or near the site where implantation occurs. The device modules may be assembled before or after the implantation target is fixed with the anchor, and then placed using the placement system in a manner similar to how a preassembled percutaneous valve device may be placed in accordance with the invention.