Inflatable Transcatheter Intracardiac Devices and Methods For Treating Incompetent Atrioventricular Valves

Abstract

Inflatable heart valve implants and methods utilizing those valves designed to reduce or eliminate the regurgitant jet associated with an incompetent atrioventricular valve. The heart valve implants, which are deployed via a transcatheter venous approach, comprise an inflatable balloon portion movably connected to an anchored guide shaft and movable from a distal position in the ventricle to a more proximal position between leaflets of a native atrioventricular valve. The range of movement of the inflatable valve body can be adjusted in situ after or before the guide shaft has been anchored to native heart tissue during surgery.

1 . A heart valve implant comprising:
 a guide shaft comprising a first end and a second end;   an active endocardial attachment mechanism coupled to said guide shaft proximate said first end;   an inflatable valve body slidably connected to said guide shaft within a predetermined range of movement, said inflatable valve body comprising an outer dimension;   at least one range limiting structure connected to said guide shaft for changing the range of movement of said inflatable valve body relative to said guide shaft, said range limiting structure comprising at least one filament which is connected to said guide shaft and not fixedly connected to said inflatable valve body.   
     
     
         2 . A heart valve implant according to  claim 1  wherein said range limiting structure is selectively movable relative to said guide shaft. 
     
     
         3 . A heart valve implant according to  claim 1  wherein said range limiting structure is configured for the in situ adjustment of said predetermined range of movement of said inflatable valve body relative to said guide shaft. 
     
     
         4 . A heart valve implant according to  claim 3  wherein said inflatable valve body is slidably mounted on said guide shaft. 
     
     
         5 . A heart valve implant according to  claim 1  wherein said inflatable valve body is slidably mounted on said guide shaft. 
     
     
         6 . A heart valve implant according to  claim 1  wherein said range limiting structure further comprises an attachment ring which is selectively movable relative to said guide shaft. 
     
     
         7 . A heart valve implant according to  claim 6  wherein said guide shaft comprises at least one recess adapted to receive said attachment ring. 
     
     
         8 . A heart valve implant according to  claim 1  wherein said range limiting structure comprises at least one suture ring. 
     
     
         9 . A heart valve implant according to  claim 1  wherein said inflatable valve body comprises discernible markers which can be detected radiographically during surgery. 
     
     
         10 . A heart valve implant according to  claim 1  wherein said range limiting structure comprises a plurality of filaments. 
     
     
         11 . A heart valve implant according to  claim 1  wherein said at least one filament comprises at least one proximal filament which is connected to said guide shaft, 
       said range limiting structure further comprises a first filament formed into a ring having an internal dimension which is less than said outer dimension of said inflatable valve body, 
       said proximal filament comprises a distal portion connected to said first filament, 
       and said range limiting structure further comprises
 at least one distal filament which is connected to said guide shaft and to said first filament for limiting the movement of said first filament in the proximal direction. 
 
     
     
         12 . A heart valve implant according to  claim 11  wherein said at least one proximal filament is directly connected to said guide shaft for limiting the movement of said first filament in a distal direction and said at least one distal filament is directly connected to said guide shaft for limiting the movement of said first filament in a proximal direction. 
     
     
         13 . A heart valve implant according to  claim 11  wherein said range limiting structure is configured for the in situ adjustment of said at least one proximal filament and of said at least one distal filament relative to said guide shaft in order to adjust the range of movement of said inflatable valve body relative to said guide shaft. 
     
     
         14 . A heart valve implant according to  claim 1  wherein said at least one filament comprises a flexible ePTFE suture material. 
     
     
         15 . A heart valve implant comprising:
 a guide shaft comprising a first end and a second end;   an active endocardial attachment mechanism coupled to said guide shaft proximate said first end;   an inflatable valve body slidably connected to said guide shaft for movement to different positions on said guide shaft during systolic and diastolic portions of the heart cycle within a predetermined range of movement, said inflatable valve body comprising an outer dimension; and   a plurality of flexible filaments connected to said guide shaft which limit the range of movement of said inflatable valve body relative to said guide shaft.   
     
     
         16 . A heart valve implant according to  claim 15  wherein said plurality of flexible filaments comprise ePTFE suture material. 
     
     
         17 . A heart valve implant according to  claim 15  wherein said plurality of flexible filaments are selectively, movably connected to said guide shaft. 
     
     
         18 . A heart valve implant according to  claim 15  wherein said range of movement is adjustable. 
     
     
         19 . A heart valve implant according to  claim 15  wherein said inflatable valve body is slidably mounted on said guide shaft. 
     
     
         20 . A heart valve implant according to  claim 15  further comprising at least one attachment ring connected to said flexible filaments and selectively, adjustable with respect to said guide shaft. 
     
     
         21 . A heart valve implant according to  claim 15  wherein said inflatable valve body is tapered on at least one end. 
     
     
         22 . A heart valve implant according to  claim 21  wherein said inflatable valve body is tapered on both ends. 
     
     
         23 . A method of deploying a heart valve implant in a patient comprising the steps of: 
       providing a heart valve implant comprising:
 a guide shaft comprising a first end and a second end; 
 an anchor coupled to said shaft proximate said first end; 
 an inflatable valve body slidably connected to said guide shaft for movement to different positions on said guide shaft during systolic and diastolic portions of the heart cycle within a predetermined range of movement, said valve body comprising an outer dimension; 
 at least one range limiting structure connected to said guide shaft and said inflatable valve body for changing the range of movement of said valve body relative to said guide shaft; 
 positioning said heart valve implant at least partially within a heart via a transcatheter venous procedure; 
 securing said anchor to native heart tissue; and 
 adjusting the range of movement of said inflatable valve body relative to said guide shaft.