Percutaneous heart valve with stentless support

Abstract

An implantable prosthetic valve having a stentless support structure. The valve has a tubular annular support structure with a first inflatable ring at a proximal end, a second inflatable ring at a distal end, and an inflatable intermediate support in between the first and second inflatable rings. There is at least one moveable occluder that controls the flow of blood through the tubular support structure. The tubular support structure can be filled with inflation media in the first inflatable ring, the second inflatable ring and inflatable intermediate support structure to convert the tubular support structure from a collapsed configuration to a patent tubular configuration.

1 . A flow control device dimensioned for implantation in a human pulmonary vein, the device comprising an inflatable support structure and at least one moveable occluder that controls the flow of blood into and out of the pulmonary veins. 
   
   
       2 . The device of  claim 1  where the device contains a therapeutic agent that is gradually released. 
   
   
       3 . The device of  claim 2  where the therapeutic agent is contained in a polymer coating on at least a portion of the device. 
   
   
       4 . The device of  claim 3  where the polymer is a bioerodable polymer 
   
   
       5 . The device of  claim 3  where the therapeutic agent is contained within porosity of the polymer. 
   
   
       6 . A method of monitoring a patient, comprising monitoring the blood flow through the pulmonary veins during the implantation of the device of  claim 1 . 
   
   
       7 . The method of  claim 6  using Trans Esophageal Echocardiography (TEE) 
   
   
       8 . The method of  claim 6  using Trans Thoracic Echocardiography (TTE) 
   
   
       9 . The method of  claim 6  using Intracardiac Echocardiography 
   
   
       10 . A method of monitoring blood pressure comprising monitoring blood pressure through the pulmonary veins during the implantation of the device of  claim 1 . 
   
   
       11 . The method of  claim 10  further comprising measuring wedge pressure. 
   
   
       12 . A method of visualization of the position of a valve comprising visualizing the position of the valve of  claim 1  during implantation using fluoroscopy. 
   
   
       13 . The method of visualization of the position of the valve of  claim 1  during implantation using Magnetic resonance imagine (MRI) 
   
   
       14 . A method of treating a patient comprising rerouting blood flow from the pulmonary veins into a prosthetic chamber, and then back into a portion of the heart. 
   
   
       15 . The method of  claim 14  where the procedure is accomplished percutaneously. 
   
   
       16 . The method of  claim 14  where the procedure is accomplished thorascopicaly. 
   
   
       17 . The method of  claim 14  where the procedure is accomplished surgically. 
   
   
       18 . The method of  claim 14  where the procedure is accomplished on a beating heart. 
   
   
       19 . The method of  claim 14  where the prosthetic chamber includes a flow control device. 
   
   
       20 . The method of  claim 19  where the flow control device permits flow in one direction, but restricts flow in a second direction. 
   
   
       21 . The method of  claim 14  where the return conduit is attached to the left ventricle. 
   
   
       22 . the method of  claim 14  where the return conduit is attached near the apex of the heart. 
   
   
       23 . The method of  claim 14  where the return conduit is attached in a first step, and a portion of the pulmonary veins are connected to the prosthetic chamber, before all of the pulmonary veins are disconnected from the native atrium. 
   
   
       24 . A prosthetic chamber made from implantable materials, including a one way valve, an outlet conduit and more than one inlet conduit and the inlet conduits are designed to attach to the pulmonary veins. 
   
   
       25 . The device of  claim 24  where the conduits are manufactured from a woven fabric tube. 
   
   
       26 . The device of  claim 24  where the valve is a tissue valve. 
   
   
       27 . The device of  claim 24  where the valve is a mechanical valve. 
   
   
       28 . The device of  claim 27  where the valve is a single leaflet valve. 
   
   
       29 . The device of  claim 27  where the valve is a bileaflet valve.