Modular percutaneous valve structure and delivery method

Abstract

A modular prosthetic valve device for implantation in a patient and a system for and method of delivering such a modular valve device and assembling it in vivo are disclosed. The valve device is designed as two or more modules to be delivered unassembled, spatially separate, and combined into an assembled valve device in the body at or near the site of implantation. The valve device of the invention is deliverable as modules, providing a smaller delivery diameter than pre-assembled percutaneous valves, permitting use of a delivery device of reduced diameter, and increasing the flexibility of the valve device during delivery, compared to percutaneous valve devices in the art. The modules of the valve device may be connected by pull wires for delivery sequentially, and then assembled by remote manipulation using the pull wires. Various locking mechanisms are provided for attaching the device modules together.

What is claimed is: 
     
         1 . A system for assembling a modular prosthetic percutaneous valve device in a body in need thereof, said system comprising a percutaneous delivery device and said valve device contained within said delivery device,
 said valve device comprising a plurality of device modules including a support structure and a valve module, said valve module including a locking mechanism formed integral thereto which locks together said support structure and said valve module, wherein the valve module comprises a leaflets substructure having a flattened unassembled one-layer structure which is folded into a delivery configuration, said leaflets substructure having a first end and a second end which are brought into a ring shape as a working configuration,   wherein said device modules are assembled into a working configuration valve device after deployment from the percutaneous delivery device and locked in said working configuration via said locking mechanism.   
     
     
         2 . The system of  claim 1 , further comprising a temporary valve, wherein the temporary valve has one of a single piece construction and a multi-piece construction. 
     
     
         3 . The system of  claim 2 , wherein said temporary valve is coextensive with said delivery device. 
     
     
         4 . The system of  claim 1 , further comprising a pull-wire. 
     
     
         5 . The system of  claim 1 , further comprising a push-rod. 
     
     
         6 . A modular prosthetic percutaneous valve device comprising a plurality of device modules including a support structure and a valve module, said valve module including a locking mechanism formed integral thereto which locks together said support structure and said valve module, wherein the valve module comprises a leaflets substructure having a flattened unassembled one-layer structure which is folded into a delivery configuration, said leaflets substructure having a first end and a second end which are brought into a ring shape as a working configuration,
 wherein said device modules are assembled into a working configuration valve device after deployment from a percutaneous delivery device and locked in said working configuration via said locking mechanism.   
     
     
         7 . The valve device of  claim 6 , wherein said leaflets substructure has first and second locking members which interlock said first end and said second end of the leaflets substructure in the working configuration. 
     
     
         8 . The valve device of  claim 7 , wherein said first locking member formed on the first end of said leaflets substructure and said second locking member formed on the second end of said leaflets substructure. 
     
     
         9 . The valve device of  claim 7 , wherein said first and second locking members are complementary interlocking to each other, and said first locking member is formed on an inner surface of said first end of the leaflets substructure and said second locking members is formed on an outer surface of said second end of the leaflets substructure, wherein the leaflets substructure is partially overlapped in the working configuration. 
     
     
         10 . The valve device of  claim 6 , wherein the locking mechanism is a curvilinear groove mechanism. 
     
     
         11 . The valve device of  claim 6 , further comprising a self-assembly member. 
     
     
         12 . A system for assembling a modular prosthetic percutaneous valve device in a body in need thereof, said system comprising a percutaneous delivery device and said valve device contained within said delivery device,
 said valve device comprising a plurality of device modules including a support structure and a valve module, said valve module including a locking mechanism formed integral thereto which locks together said support structure and said valve module, wherein the valve module comprises a leaflets substructure having a flattened unassembled one-layer structure which is loaded into a delivery configuration, said leaflets substructure having a first end and a second end which are brought into a ring shape as a working configuration,   wherein said device modules are assembled into a working configuration valve device after deployment from the percutaneous delivery device and locked in said working configuration via said locking mechanism.   
     
     
         13 . The system of  claim 12 , further comprising a temporary valve, wherein the temporary valve has one of a single piece construction and a multi-piece construction. 
     
     
         14 . The system of  claim 13 , wherein said temporary valve is coextensive with said delivery device. 
     
     
         15 . The system of  claim 12 , further comprising a pull-wire. 
     
     
         16 . The system of  claim 12 , further comprising a push-rod. 
     
     
         17 . A modular prosthetic percutaneous valve device comprising a plurality of device modules including a support structure and a valve module, said valve module including a locking mechanism formed integral thereto which locks together said support structure and said valve module, wherein the valve module comprises a leaflets substructure having a flattened unassembled one-layer structure which is loaded into a delivery configuration, said leaflets substructure having a first end and a second end which are brought into a ring shape as a working configuration,
 wherein said device modules are assembled into a working configuration valve device after deployment from a percutaneous delivery device and locked in said working configuration via said locking mechanism.   
     
     
         18 . The valve device of  claim 17 , wherein said leaflets substructure has first and second locking members which interlock said first end and said second end of the leaflets substructure in the working configuration. 
     
     
         19 . The valve device of  claim 18 , wherein said first locking member formed on the first end of said leaflets substructure and said second locking member formed on the second end of said leaflets substructure. 
     
     
         20 . The valve device of  claim 18 , wherein said first and second locking members are complementary interlocking to each other, and said first locking member is formed on an inner surface of said first end of the leaflets substructure and said second locking members is formed on an outer surface of said second end of the leaflets substructure, wherein the leaflets substructure is partially overlapped in the working configuration. 
     
     
         21 . The valve device of  claim 17 , wherein the locking mechanism is a curvilinear groove mechanism. 
     
     
         22 . The valve device of  claim 17 , further comprising a self-assembly member.