Leaflet Valve

Abstract

A device and method for improving flow through a native blood vessel valve, such as the aortic valve, are provided. The present invention allows a miniature valve to be implanted into affected leaflets percutaneously, obviating the need for coronary bypass surgery. The method includes the cutting of small holes, on the order of 4 mm, in the leaflets of a targeted valve, thereby allowing blood to flow through the newly formed holes. The holes are used as attachment sites for the miniature valves of the present invention.

1 . A method of implanting a prosthetic valve assembly into a target site comprising:
 inserting at least a portion of the valve assembly into the target site in a distal direction;   allowing a distal portion of the valve assembly to flare radially such that the radially flared distal portion engages tissue of the target site; and   releasing a remaining portion of the valve assembly.   
     
     
         2 . The method of  claim 1  wherein inserting at least a portion of the valve assembly into the target site in a distal direction comprises inserting at least a portion of the valve assembly between leaflets of a target native valve. 
     
     
         3 . The method of  claim 1  wherein allowing a distal portion of the valve assembly to flare radially comprises allowing a distal portion of a deformable housing of the valve assembly to flare radially. 
     
     
         4 . The method of  claim 1  further comprising using friction between the valve assembly and the target site to hold the valve assembly in place. 
     
     
         5 . The method of  claim 4  wherein using friction between the valve assembly and the target site to hold the valve assembly in place comprises providing a mesh housing material. 
     
     
         6 . The method of  claim 1  wherein allowing a distal portion of the valve assembly to flare radially comprises allowing a distal cuff to flare radially. 
     
     
         7 . A fluid control valve, transluminally deliverable via a catheter to a target site in a patient, comprising:
 a deformable mesh housing structure including a radially expandable anchoring mechanism; and,   a flow control mechanism coupled to said deformable housing structure.   
     
     
         8 . The fluid control valve of  claim 7  wherein said anchoring mechanism comprises a cuff. 
     
     
         9 . The fluid control valve of  claim 7  wherein said radially expandable anchoring mechanism includes a distal end that, when said fluid control valve is compressed into a catheter, comprises a distal end of the fluid control valve. 
     
     
         10 . The fluid control valve of  claim 7  wherein said flow control mechanism comprises a sleeve. 
     
     
         11 . The fluid control valve of  claim 10  wherein said sleeve has a distal end and a proximal end, said distal end coupled to said deformable housing structure. 
     
     
         12 . The fluid control valve of  claim 11  wherein said distal end of said sleeve is coupled to an inside surface of said deformable housing structure. 
     
     
         13 . The fluid control valve of  claim 11  wherein said proximal end extends proximally out of said deformable housing structure. 
     
     
         14 . The fluid control valve of  claim 7  wherein said anchoring mechanism comprises radially self-expanding legs. 
     
     
         15 . A system for transluminally delivering a replacement fluid control valve to a target site in a patient comprising:
 a delivery catheter;   a radially compressible and expandable mesh cuff having a compressed state allowing said cuff to be contained within said delivery catheter and an expanded state that anchors said cuff to a target site in a patient;   a flow control mechanism having a sleeve and a plurality of valve members, said sleeve having a distal portion and a proximal portion, said distal portion operably coupled to and within said cuff.   
     
     
         16 . The system of  claim 15  wherein said cuff has a distal end that expands as said cuff exits said delivery catheter. 
     
     
         17 . The system of  claim 15  wherein said proximal portion of said flow control mechanism extends proximally out of said cuff. 
     
     
         18 . The system of  claim 16  wherein said distal end of said cuff flares outwardly during expansion. 
     
     
         19 . The system of  claim 15  wherein said cuff has a proximal end that surrounds said distal portion of said sleeve. 
     
     
         20 . The system of  claim 16  wherein said distal end of said cuff is constructed and arranged to expand as said cuff exits said delivery catheter such that said distal end of said cuff contacts tissue prior to a remaining portion of said cuff exiting said delivery catheter.