Aortic Valve Repair

Abstract

The present invention provides devices and methods for decalcifying an aortic valve. The methods and devices of the present invention break up or obliterate calcific deposits in and around the aortic valve through application or removal of heat energy from the calcific deposits.

1 . A treatment catheter for cardiac valve repair, the treatment catheter comprising:
 a catheter body comprising a proximal end and a distal end;   means near the distal end of the catheter body for creating an embolic containment region over a localized calcific site on or near a cardiac valve; and   a working element adapted to disrupt the calcific site, said working element being positionable within the embolized containment region.   
     
     
         2 . The treatment catheter of  claim 1  wherein the working element comprises an energy delivery element such as ultrasonic element delivering energy under conditions selected to disrupt calcific deposits at the calcific site. 
     
     
         3 . The treatment catheter of  claim 1  wherein the catheter body is steerable or otherwise positionable to allow a user to direct the distal end toward the calcific site. 
     
     
         4 . The treatment catheter of  claim 1  further comprising a positioning structure on the catheter body for positioning and/or stabilizing the working element adjacent the calcific site. 
     
     
         5 . The treatment catheter of  claim 1  wherein the embolic containment creating means comprise a shaped balloon, a basket, or a filter. 
     
     
         6 . The treatment catheter of  claim 5  wherein the embolic containment means comprise a filter located on the treatment catheter, a perfusion balloon linked with an aspiration device, a suction catheter, a separate filter device either at the treatment site or downstream from the treatment site, or an external filter and perfusion system. 
     
     
         7 . The treatment catheter of  claim 6  wherein the protection device comprises a filter that is shaped to allow the treatment catheter to access a location to be treated, while still allowing flow through the diseased aortic valve. 
     
     
         8 . The treatment catheter of  claim 1  comprising a protection device that traps and/or evacuates debris from a treatment site around the diseased aortic valve. 
     
     
         9 . The treatment catheter of  claim 1  further comprising an imaging assembly. 
     
     
         10 . The treatment catheter of  claim 9  wherein the imaging element comprises an intracardiac echocardiography (ICE) assembly, transesophageal echocardiography (TEE) assembly, intravascular ultrasound assembly, or angioscopy assembly. 
     
     
         11 . A system comprising the treatment catheter of  claim 1 , further comprising a guide catheter comprising an inner lumen that is configured to receive the treatment catheter. 
     
     
         12 . The system of  claim 11  further comprising a secondary positioning catheter that is positionable within the inner lumen of the guide catheter and around the treatment catheter. 
     
     
         13 . The treatment catheter of  claim 1  wherein the working element comprises an RF electrode. 
     
     
         14 . The treatment catheter of  claim 1  wherein the working element comprises a rotatable tip. 
     
     
         15 . The treatment catheter of  claim 14  wherein the rotatable tip comprises a coil. 
     
     
         16 . The treatment catheter of  claim 14  wherein the rotatable tip comprises an impeller. 
     
     
         17 . The treatment catheter of  claim 14  wherein the rotatable tip comprises a grinder. 
     
     
         18 . The treatment catheter of  claim 14  comprising a sheath that is disposed over the rotatable tip. 
     
     
         19 . The treatment catheter of  claim 1  wherein the distal end of the catheter body comprises a suction housing.