Steerable Catheter and Dilator and System and Method for Implanting a Heart Implant

Abstract

A catheter according to one embodiment may be configured to extend through a transseptal puncture site, a left atrium, and into a left ventricle. The catheter may comprise a shaft defining at least one lumen configured to receive at least one of an implant and/or a dilator, a first steerable actuator coupled to the shaft at a position on the shaft substantially corresponding to the annulus of the mitral valve when the distal end of the shaft is disposed within the left ventricle, and a handle assembly coupled to a proximal end of the shaft. The handle assembly may comprise a first actuator coupled to the first steerable actuator. The first actuator may be configured to apply a force to the first steerable actuator to deflect the shaft about a region proximate to the first steerable actuator.

What is claimed is: 
     
         1 . A catheter configured to extend through a transseptal puncture site, a left atrium, and into a left ventricle, said catheter comprising:
 a shaft defining at least one lumen configured to receive at least one of an implant and/or a dilator;   a first steerable actuator coupled to said shaft at a position on said shaft substantially corresponding to said transseptal puncture site when a distal end of said shaft is disposed within said left ventricle; and   a handle assembly coupled to a proximal end of said shaft, said handle assembly comprising a first actuator coupled to said first steerable actuator, said first actuator configured to apply a force to said first steerable actuator to deflect said shaft about a region proximate to said first steerable actuator.   
     
     
         2 . The catheter of  claim 1 , wherein said first actuator coupled to said shaft at said position corresponding to 1.5-4 inches from said distal end. 
     
     
         3 . The catheter of  claim 2 , wherein said position corresponds to 3 inches from said distal end. 
     
     
         4 . The catheter of  claim 1 , wherein said first steerable actuator comprises a first pull ring coupled to said shaft. 
     
     
         5 . The catheter of  claim 4 , wherein said first actuator is coupled to said first pull ring shaft with at least a first wire. 
     
     
         6 . The catheter of  claim 5 , wherein said first wire is disposed within a second lumen of said shaft. 
     
     
         7 . The catheter of  claim 1 , wherein said first steerable actuator is configured to deflect said shaft to form a first curve up to 180 degrees. 
     
     
         8 . The catheter of  claim 7 , wherein said first curve of said shaft comprises a radius of between 1.0 inches and 2.0 inches. 
     
     
         9 . The catheter of  claim 8 , wherein said first curve of said shaft comprises a radius of between 1.25 inches and 1.75 inches. 
     
     
         10 . The catheter of  claim 1 , further comprising at least a second steerable actuator coupled to said shaft proximate said distal end of said shaft. 
     
     
         11 . The implant of  claim 10 , wherein said second steerable actuator comprises a second pull ring coupled to said shaft. 
     
     
         12 . The catheter of  claim 11 , wherein said second steerable device is coupled to a second actuator disposed in said handle assembly, said second actuator configured to apply a force to said second actuator to deflect said shaft about a region between said first steerable actuator and said second steerable actuator. 
     
     
         13 . The catheter of  claim 12 , wherein said second steerable actuator comprises a second pull ring. 
     
     
         14 . The catheter of  claim 13 , wherein said second actuator is coupled to said second pull ring shaft with at least a second wire. 
     
     
         15 . The catheter of  claim 12 , wherein said second steerable actuator is configured to deflect said shaft to form a second curve up to 180 degrees. 
     
     
         16 . The catheter of  claim 15 , wherein said second curve of said shaft comprises a radius of between 1.0 inches and 2.0 inches. 
     
     
         17 . The catheter of  claim 16 , wherein said second curve of said shaft comprises a radius of between 1.25 inches and 1.75 inches. 
     
     
         18 . The catheter of  claim 1 , wherein said shaft comprises a plurality of segments, each segment having a different stiffness compared to adjacent segments. 
     
     
         19 . The catheter of  claim 18 , wherein said plurality of segments comprises a first segment disposed proximate said distal end of said shaft, a second segment disposed adjacent to said first segment, and a third segment extend from said proximal end to said second segment, wherein said first segment is the lowest stiffness and said third segment is the highest stiffness of said plurality of segments. 
     
     
         20 . The catheter of  claim 19 , wherein said first segment is 8 inches long and said second segment is 2.5 inches long. 
     
     
         21 . The catheter of  claim 19 , wherein said first segment has a durometer of 25 D, said second segment has a durometer of 40 D, and said third segment has a durometer of 72 D. 
     
     
         22 . The catheter of  claim 1 , wherein said shaft comprises a first section disposed proximate said distal end configured to provide kink resistance when deflecting said first section, a second section extending from said first section towards said handle assembly configured to provide kink resistance when deflecting said second section and a third section extending from a proximal end of said second spiral reinforced section to the handle assembly configured to increase the pushability and torsional strength of the shaft while reducing and/or minimizing kinking. 
     
     
         23 . The catheter of  claim 22 , wherein first section comprises a spiral reinforced secton. 
     
     
         24 . The catheter of  claim 23 , wherein said first section comprises a length of 1-3 inches. 
     
     
         25 . The catheter of  claim 22 , wherein said second section comprises a spiral reinforced section 
     
     
         26 . The catheter of  claim 25 , wherein said second section comprises a length of 7.5 inches. 
     
     
         27 . The catheter of  claim 22 , wherein said third section comprises a braided reinforced section. 
     
     
         28 . The catheter of  claim 1 , further comprising a dilator configured to be received within said lumen of said shaft. 
     
     
         29 . The catheter of  claim 1 , further comprising an implant configured to be received within said lumen of said shaft.