Apparatus And Methods For Minimally Invasive Transcatheter Transapical Puncture, Imaging, And Catheter Alignment Techniques

Abstract

A delivery catheter system includes a guide catheter, an anchor catheter, a collapsible and expandable anchor, a balloon formed from a portion of the positioning catheter, and a needle. The anchor may be for anchoring a prosthetic heart valve in a native heart valve. The anchor may be configured to be received within the anchor catheter. The balloon may be inflated or deflated and provide mechanical support to enable the needle to pierce a ventricle wall. A metallic guide wire can simultaneously be inserted through the aorta to outline the heart when viewed through fluoroscopic imaging.

1 . A delivery catheter system comprising:
 a guide catheter;   an anchor catheter;   a collapsible and expandable anchor for anchoring a prosthetic heart valve in a native heart valve, the anchor configured to be received within the anchor catheter;   a balloon formed along a length of the guide catheter, the balloon being inflatable via a lumen in fluid communication with the balloon; and   a needle positioned radially inward of the guide catheter and translatable relative to the balloon, the needle having a distal tip configured to pierce tissue.   
     
     
         2 . The delivery catheter system of  claim 1 , wherein the guide catheter is steerable via at least one pull wire. 
     
     
         3 . The delivery catheter system of  claim 1 , further comprising a positioning catheter positioned radially outward of the anchor catheter, the anchor catheter being translatable relative to the positioning catheter. 
     
     
         4 . The delivery catheter system of  claim 2 , further comprising a spring element positioned between the balloon and a distal end of the guide catheter, the spring element biasing the guide catheter toward a straight condition. 
     
     
         5 . The delivery catheter system of  claim 4 , wherein the at least one pull wire and the spring element are positioned on substantially diametrically opposite sides of the guide catheter, so that pulling the at least one pull wire tends to flex or compress the spring element. 
     
     
         6 . The delivery catheter system of  claim 4 , wherein the at least one pull wire and the balloon are positioned on substantially opposite sides of the guide catheter, so that pulling the at least one pull wire tends to flex the distal end of the guide catheter away from the balloon. 
     
     
         7 . The delivery catheter system of  claim 1 , wherein the balloon, when inflated, is configured to contact an interior surface of a left atrium. 
     
     
         8 . The delivery catheter system of  claim 7 , wherein contact between the inflated balloon and the interior surface of the left atrium is configured to counteract forces resulting from the needle piercing tissue of a left ventricle. 
     
     
         9 . The delivery catheter system of  claim 7 , wherein when the balloon is in a deflated condition, the balloon forms a portion of an exterior wall surface of the guide catheter. 
     
     
         10 . The delivery catheter system of  claim 9 , wherein the balloon, when in the deflated condition, does not increase a profile of the guide catheter. 
     
     
         11 . A method of delivering an expandable anchor for a prosthetic heart valve to a heart of a patient, the method comprising:
 advancing a guide catheter into a left atrium of the patient, the guide catheter including a balloon formed along a portion of the guide catheter;   advancing an anchor catheter from within the guide catheter to a left ventricle of the heart of the patient, the anchor catheter configured to maintain the anchor in a collapsed condition;   inflating the balloon so that the balloon contacts an interior wall of the left atrium;   advancing a needle positioned radially within the anchor catheter distally relative to the anchor catheter and through a ventricular wall of the heart of the patient to create a transapical puncture while the balloon contacts the interior wall of the left atrium;   advancing the anchor catheter at least partially through the transapical puncture; and   releasing the anchor from the anchor catheter and allowing the anchor to transition from the collapsed condition to an expanded condition while the anchor catheter is positioned at least partially through the transapical puncture.   
     
     
         12 . The method of  claim 11 , wherein the step of inflating the balloon is performed after the anchor catheter is advanced to the left ventricle. 
     
     
         13 . The method of  claim 11 , further comprising deflecting a distal end of the guide catheter toward a native mitral valve annulus prior to advancing the anchor catheter into the left ventricle, so that the distal end of the guide catheter is substantially aligned with a central longitudinal axis passing through the native mitral valve annulus. 
     
     
         14 . The method of  claim 13 , wherein deflecting the distal end of the guide catheter is performed by tensioning a pull wire. 
     
     
         15 . The method of  claim 14  wherein the guide catheter includes a spring element positioned between the balloon and the distal end of the guide catheter, the spring element biasing the guide catheter toward a straight condition. 
     
     
         16 . The method of  claim 15 , wherein the pull wire and the spring element are positioned on substantially diametrically opposite sides of the guide catheter, so that tensioning the pull wire tends to flex or compress the spring element. 
     
     
         17 . The method of  claim 14 , wherein the pull wire and the balloon are positioned on substantially opposite sides of the guide catheter, so that tensioning the pull wire tends to flex the distal end of the guide catheter away from the balloon 
     
     
         18 . The method of  claim 11 , wherein the balloon at least partially conforms to the interior wall of the left atrium after inflating the balloon. 
     
     
         19 . The method of  claim 11 , wherein the balloon remains inflated against the interior wall of the left atrium after the needle is advanced through the ventricular wall and before the anchor catheter is at least partially advanced through the transapical puncture. 
     
     
         20 . The method of  claim 11 , wherein when the balloon is in a deflated condition, the balloon forms a portion of an exterior wall surface of the guide catheter.