Catheter deliverable artificial multi-leaflet heart valve prosthesis and intravascular delivery system for a catheter deliverable heart valve prosthesis

Abstract

A heart valve prosthesis includes a collapsible stent and a one-piece multi-leaflet valve. The stent includes at least one length of wire having a series of turns forming a spring-like stent. The one-piece multi-leaflet valve is attached to the stent and includes a cylinder of polyester material secured thereto at three points. The stent is collapsible in a radial direction between a contracted state and an expanded state. The contracted state has a radial dimension smaller than a radial dimension of the expanded state. The stent is spring biased toward the expanded state such that it occupies an active state when implanted into a heart. The active state has a radial dimension that is between the radial dimension of the contracted state and the radial dimension of the expanded state such that a radial load generated by the bias of the collapsible stent is sufficient to retain the heart valve prosthesis in the heart.

1 .- 10 . (canceled) 
     
     
         11 . A system for intravascular delivery of a heart valve prosthesis, the system comprising:
 a handle;   a flexible elongated sheath extending from the handle;   a cavity defined by an end of the elongated sheath that is disposed opposite the handle, the cavity adapted to contain a heart valve prosthesis during intravascular delivery of the heart valve prosthesis;   a tapered tip coupled to the end of the elongated sheath adjacent to the cavity, the tapered tip adapted to guide the elongated sheath during intravascular delivery of the heart valve prosthesis, the tapered tip and the elongated sheath being separable such that the heart valve prosthesis can be released from the cavity in the elongated sheath upon proper positioning of the heart valve prosthesis.   
     
     
         12 . The system of  claim 11 , wherein the elongated sheath has an inner diameter of less than or equal to 7 mm and an outer diameter of less than or equal to 8 mm. 
     
     
         13 . The system of  claim 11 , further comprising a string connected to the elongated sheath at a location adjacent the cavity and extending through the sheath to the handle such that a user can pull the string to bend the elongated sheath to facilitate navigation of the elongated sheath during intravascular delivery of the heart valve prosthesis. 
     
     
         14 . The system of  claim 11 , further comprising a stop plug disposed in the elongated sheath adjacent the cavity, the stop plug preventing the heart valve prosthesis from traveling into the elongated sheath beyond the cavity. 
     
     
         15 . The system of  claim 11 , wherein the elongated sheath is movable mounted to the handle such that movement of the sheath toward the handle separates the elongated sheath and the tapered tip. 
     
     
         16 . (canceled) 
     
     
         17 . (canceled)