System and method for placing a percutaneous valve device

Abstract

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 pre-assembled 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 pre-assembled percutaneous valve device may be placed in accordance with the invention.

What is claimed is: 
     
         1 . A system for improving placement accuracy of a prosthetic percutaneous valve, comprising:
 a prosthetic percutaneous valve device;   an anchor, with the proviso that said anchor is not a leading suture; and   a delivery device;   wherein said anchor is configured for affixing to a selected location in a body lumen in need of a replacement valve prior to deployment of said valve from said delivery device, and is configured for positioning said valve device at said location.   
     
     
         2 . The system of  claim 1 , wherein said anchor is an anchor docking apparatus and said percutaneous valve device comprises an anchor interface unit configured to engage with said anchor docking apparatus. 
     
     
         3 . The system of  claim 1 , wherein said percutaneous valve device is a modular valve device comprising a plurality of device modules, wherein the plurality of device modules comprises a support structure and a valve module, said valve module selected from the group consisting of: a plurality of valve sections, a leaflets substructure, and a leaflets-ring. 
     
     
         4 . The system of  claim 3 , wherein said plurality of device modules are spatially separate during delivery. 
     
     
         5 . The system of  claim 3 , wherein each of said plurality of device modules comprises a reduced profile during delivery relative to a delivered configuration. 
     
     
         6 . The system of  claim 2 , wherein said anchor docking apparatus has a delivery configuration and a deployment configuration, said anchor docking apparatus comprising a material selected from the group consisting of: a shape memory material, Nitinol, and superelastic material. 
     
     
         7 . The system of  claim 1 , wherein said valve device is a pre-assembled valve device comprising a valve member and a device frame. 
     
     
         8 . A system for improving placement accuracy of a percutaneous prosthetic valve, comprising:
 a prosthetic percutaneous valve device;   an anchor for affixing to a selected location prior to deployment of said valve device, and for positioning said valve device at said location, wherein said anchor is a tissue attachment device; and   a placement wire attached to said tissue attachment device; and   a delivery device.   
     
     
         9 . The system of  claim 8 , wherein said tissue attachment device is selected from the group consisting of: a button, a rivet-type device, a hook, and interconnecting geometries, and wherein said placement wire is capable of being threaded through a portion of said valve device. 
     
     
         10 . The system of  claim 8 , wherein said prosthetic valve device comprises an anchor interface unit, and said anchor is an anchor docking apparatus, wherein said anchor interface unit and said anchor docking apparatus are designed to engage one another. 
     
     
         11 . The system of  claim 10 , wherein said docking apparatus has a delivery configuration and a deployment configuration, said docking apparatus comprising material selected from the group consisting of: a shape memory material, Nitinol, and superelastic material. 
     
     
         12 . The system of  claim 8 , wherein said percutaneous valve device is a modular valve device comprising a plurality of device modules, wherein the plurality of device modules comprise a support structure and a valve module, said valve module selected from the group consisting of: a plurality of valve sections, a leaflets substructure, and a leaflets ring. 
     
     
         13 . The system of  claim 12 , wherein said plurality of device modules are spatially separate during delivery. 
     
     
         14 . The system of  claim 12 , wherein each of said plurality of device modules comprises a reduced profile during delivery relative to a delivered configuration. 
     
     
         15 . The system of  claim 8 , wherein said valve device is a pre-assembled valve device comprising a valve member and a device frame.