Methods and apparatus for endovascularly replacing a patient's heart valve

Abstract

The present invention provides methods and apparatus for endovascularly replacing a patient's heart valve. The apparatus includes a replacement valve and an anchor having an expandable braid. In some embodiments, the expandable braid is fabricated from a single strand of wire. In some embodiments, the expandable braid comprises at least one turn feature. The anchor and the valve preferably are configured for endovascular delivery and deployment.

1 . Apparatus for replacing a native aortic valve, the apparatus comprising: 
 an anchor comprising an expandable braid, the anchor being adapted to be endovascularly delivered and expanded via active foreshortening at an anchor site within the native aortic valve; and    a replacement valve configured to be secured within the anchor.    
   
   
       2 . The apparatus of  claim 1  wherein the anchor comprises a central axis, the anchor being further adapted to remain substantially undeformed in response to a pressure up to 0.5 atm directed substantially radially inward toward the central axis.  
   
   
       3 . The apparatus of  claim 2  wherein the anchor is further adapted to remain substantially undeformed in response to a pressure up to 2 atm directed substantially radially inward toward the central axis.  
   
   
       4 . The apparatus of  claim 1  wherein the braid comprises a first region and a second region having a diameter larger than a diameter of the first region when the anchor is expanded.  
   
   
       5 . The apparatus of  claim 4  wherein the braid defines a plurality of cells, at least a first set of the cells in the first region each being of a substantially different configuration than a second set of the cells in the second region.  
   
   
       6 . The apparatus of  claim 5  wherein the braid further comprises a third region having a diameter larger than the first region diameter when the anchor is expanded.  
   
   
       7 . The apparatus of  claim 6  wherein the braid defines a plurality of cells, at least a first set of the cells in the first region each being of a substantially different configuration than a second set of the cells in the second region and a third set of cells in the third region.  
   
   
       8 . The apparatus of  claim 1  wherein the anchor is further adapted to avoid interference with coronary ostia.  
   
   
       9 . The apparatus of  claim 1  wherein the anchor is further adapted to avoid interference with a mitral valve.  
   
   
       10 . The apparatus of  claim 9  wherein the braid comprises a region adapted to prevent expansion of the anchor into the mitral valve.  
   
   
       11 . The apparatus of  claim 1  wherein the braid is configured to have an expanded shape that is radially symmetrical.  
   
   
       12 . The apparatus of  claim 1  wherein the braid is configured to have an expanded shape that is bilaterally symmetrical.  
   
   
       13 . The apparatus of  claim 1  wherein the delivery length is between about 15 mm and about 150 mm and the deployed length is between 5 mm and about 40 mm.  
   
   
       14 . The apparatus of  claim 1  wherein the braid is configured to have an expanded shape that is asymmetrical.  
   
   
       15 . The apparatus of  claim 1  wherein the anchor comprises first and second wires, the first wire having a diameter smaller than a diameter of the second wire.  
   
   
       16 . The apparatus of  claim 1  wherein the anchor comprises first and second wires formed from different materials.  
   
   
       17 . The apparatus of  claim 1  wherein the anchor has a collapsed delivery configuration, an at-rest configuration and an expanded deployed configuration.  
   
   
       18 . The apparatus of  claim 17  wherein the braid comprises a shape memory material that is heat set in the at-rest configuration.  
   
   
       19 . The apparatus of  claim 17  wherein the at-rest configuration is between the collapsed delivery configuration and expanded deployed configuration.  
   
   
       20 . The apparatus of  claim 1  further comprising a lock configured to maintain expansion of the braid.  
   
   
       21 . The apparatus of  claim 1  further comprising a plurality of locks configured to maintain expansion of the braid.  
   
   
       22 . The apparatus of  claim 1  further comprising a valve support adapted to support the replacement valve within the anchor.  
   
   
       23 . The apparatus of  claim 22  further comprising a lock configured to maintain expansion of the braid.  
   
   
       24 . The apparatus of  claim 23  wherein the lock comprises an extension of the valve support.  
   
   
       25 . The apparatus of  claim 1  wherein the anchor comprises a distal deployment system interface at a distal end of the anchor, the distal deployment system interface being adapted to permit a deployment system to apply a proximally directed force on the distal end of the anchor.  
   
   
       26 . The apparatus of  claim 25  wherein the distal deployment system interface is further adapted to expand radially during application of a proximally directed force on the distal end of the anchor.  
   
   
       27 . The apparatus of  claim 26  wherein the distal deployment system interface is further adapted to permit a deployment system to apply a proximally directed force on the distal end of the anchor without passing any portion of a deployment system through a center opening of the replacement valve.  
   
   
       28 . The apparatus of  claim 1  wherein the anchor comprises a proximal deployment system interface at a proximal end of the anchor, the proximal deployment system interface being adapted to permit a deployment system to apply a distally directed force on the proximal end of the anchor.  
   
   
       29 . The apparatus of  claim 28  wherein the proximal deployment system interface is further adapted to expand radially during application of a distally directed force on the proximal end of the anchor.  
   
   
       30 . The apparatus of  claim 28  wherein the proximal deployment system interface is further adapted to permit a deployment system to apply a distally directed force on the proximal end of the anchor through a plurality of deployment system fingers.