Percutaneous transcatheter repair of heart valves via trans-apical access

Abstract

Apparatus, systems, and methods are provided for repairing heart valves through percutaneous transcatheter delivery and fixation of annuloplasty rings to heart valves via a trans-apical approach to accessing the heart. A guiding sheath may be introduced into a ventricle of the heart through an access site at an apex of the heart. A distal end of the guiding sheath can be positioned retrograde through the target valve. An annuloplasty ring arranged in a compressed delivery geometry is advanced through the guiding sheath and into a distal portion of the guiding sheath positioned within the atrium of the heart. The distal end of the guiding sheath is retracted, thereby exposing the annuloplasty ring. The annuloplasty ring may be expanded from the delivery geometry to an operable geometry. Anchors on the annuloplasty ring may be deployed to press into and engage tissue of the annulus of the target valve.

What is claimed is: 
     
         1 . A system for percutaneous transcatheter delivery of an annuloplasty ring to repair a target valve of a heart via a trans-apical approach, the delivery apparatus comprising:
 a guide sheath having a lumen therethrough and configured to be positioned into the heart via an access site through a wall of the heart at the apex of the heart, the guide sheath having a length configured to be positioned through a ventricle of the heart, retrograde through the target valve, and into an atrium of the heart;   a delivery assembly configured to be positioned within the guide sheath and advanced to a distal portion of the guide sheath; and   the annuloplasty ring configured to be arranged in a compressed delivery geometry within a plane that is transverse to a longitudinal axis of the lumen of the guiding sheath, wherein the annuloplasty ring comprises a plurality of anchors configured to be pressed into and engage tissue of an annulus of the target valve.   
     
     
         2 . The system of  claim 1 , wherein the delivery assembly comprises a balloon assembly comprising:
 an upper balloon portion defining an upper surface of a recess and configured to inflate to restrict distal shifting of the annuloplasty ring relative to the recess as the delivery assembly is advanced and positioned in the target valve; and   a lower balloon portion, defining a lower surface of the recess and configured to inflate to restrict proximal shifting of the annuloplasty ring relative to the recess as the delivery assembly is advanced and positioned in the target valve;   wherein the upper balloon portion and the lower balloon of the balloon assembly are more pliant than the recess of the balloon assembly to inflate and expand more readily than the recess, and wherein inflation of the balloon assembly to cause expansion of the recess expands the annuloplasty ring from the compressed delivery geometry to an expanded operable geometry.   
     
     
         3 . The system of  claim 1 , wherein the delivery assembly comprises a balloon assembly comprising:
 an upper balloon defining an upper surface of a recess and configured to inflate to a diameter larger than the annulus of the target valve to restrict distal shifting of the annuloplasty ring and provide a surface that can be withdrawn to secure the annuloplasty ring against the annulus of the target valve; and   a lower balloon defining a lower surface of the recess and configured to inflate to expand the annuloplasty ring from the compressed delivery geometry to an expanded operable geometry, wherein the annuloplasty ring in the compressed delivery geometry is disposed within the recess of the balloon assembly.   
     
     
         4 . The system of  claim 3 , wherein the balloon assembly comprises a double lumen shaft coupling the upper balloon and the lower balloon, the double lumen shaft having a first lumen coupled to and configured to direct a fluid or gas into the upper balloon from outside the heart and having a second lumen coupled to and configured to direct a fluid or gas into the lower balloon from outside the heart. 
     
     
         5 . The system of  claim 1 , wherein the annuloplasty ring comprises free ends configured to be snapped together to decrease a diameter of the annuloplasty ring and thereby decrease a diameter of the annulus of the target valve. 
     
     
         6 . The system of  claim 1 , wherein the annuloplasty ring comprises shape memory material and a heating element to heat the shape memory material, the shape memory material configured to decreasing the diameter of the annuloplasty ring in response to heat provided by the heating element. 
     
     
         7 . The system of  claim 1 , further comprising a cinching mechanism configured to cinch the annuloplasty ring to reduce a diameter of the annuloplasty ring. 
     
     
         8 . The system of  claim 1 , wherein the anchors of the annuloplasty ring are configured to be deployed by pulling one or more sutures coupled to the anchors, the sutures extending through the guide sheath and out of the access site of the heart. 
     
     
         9 . The system of  claim 1 , further comprising a knot pusher configured to knot the suture and push the suture from outside the heart to a point inside the heart adjacent the annuloplasty ring.