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.
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:
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:
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:
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:
The invention provides a device for fine adjustment of a prosthetic valve device and a method of adjusting the position of a prosthetic valve after implantation. The adjustment mechanism includes complementary structures on a valve member and device frame that cooperate to provide relative axial and/or angular motion between the valve member and device frame (and thus the native vessel). The adjustment mechanism of the invention may also include a means for selectively maintaining the relative position of the valve member and device frame. The device and method are particularly applicable for use with a modular prosthetic valve device that is assembled in the body lumen.