Low profile delivery system for transcatheter heart valve

Abstract

A method of delivery a prosthetic heart valve includes inserting a delivery apparatus and a prosthetic heart valve into a patient's vasculature. The delivery apparatus includes a steerable guide catheter, a balloon catheter, and a flex indicator. The balloon catheter extends coaxially through the guide catheter, the prosthetic heart valve is mounted on a distal end portion of the balloon catheter, and the flex indicator is movably coupled to a handle of the guide catheter. The method further includes adjusting flexion of a steerable section of the guide catheter to position the prosthetic heart valve. The flex indicator moves relative to the handle of the guide catheter as the flexion of the steerable section is adjusted, and the handle comprises one or more visual indicators adjacent the flex indicator to provide visual indication of an amount of flexion of the steerable section of the guide catheter.

We claim: 
     
         1 . A delivery apparatus, comprising:
 a handle;   a first shaft extending distally from the handle;   an inflatable balloon disposed on a distal end portion of the first shaft;   a second shaft extending distally from the handle over at least a portion of the first shaft; and   the second shaft comprising an expandable distal end portion extending over a portion of the balloon;   wherein the distal end portion of the second shaft is configured to expand radially when the balloon is inflated from an uninflated state to an inflated state.   
     
     
         2 . The delivery apparatus of  claim 1 , wherein the distal end portion of the second shaft comprises a plurality of longitudinally extending slots defining a plurality of circumferentially spaced deflectable sections that can deflect radially outwardly from one another when the balloon is inflated. 
     
     
         3 . The delivery apparatus of  claim 2 , wherein the plurality of deflectable sections comprise a plurality of metal sections. 
     
     
         4 . The delivery apparatus of  claim 3 , wherein the distal end portion of the second shaft further comprises a further material layer overlaying each metal section. 
     
     
         5 . The delivery apparatus of  claim 4 , wherein the further material layer is overmolded onto the metal sections. 
     
     
         6 . The delivery apparatus of  claim 2 , wherein the slots intersect a terminal distal end of the distal end portion the second shaft. 
     
     
         7 . The delivery apparatus of  claim 1 , further comprising a nose piece disposed on the distal end portion of the first shaft at a location distal to the balloon, wherein a proximal end portion of the nose piece is configured to deflect radially outward when the balloon is inflated from an uninflated state to an inflated state. 
     
     
         8 . The delivery apparatus of  claim 7 , wherein the nose piece comprises a plurality of slots defining a plurality of deflectable nose piece segments. 
     
     
         9 . An assembly, comprising:
 a delivery apparatus comprising
 a handle, 
 a first shaft extending distally from the handle, the first shaft having a distal end portion, 
 an inflatable balloon mounted on the distal end portion of the first shaft, 
 a second shaft extending distally from the handle at least partially over the first shaft, the second shaft having a distal end portion comprising a plurality of longitudinally extending fingers spaced apart from one another in a circumferential direction by a plurality of longitudinally extending slots; and 
   a prosthetic heart valve that is radially expandable and compressible between a radially compressed configuration and a radially expanded configuration, wherein the prosthetic heart valve is mounted on the balloon in the radially compressed configuration;   wherein the distal end portion of the second shaft extends at least partially over the balloon such that as the balloon is inflated from an uninflated state to an inflated state to expand the prosthetic heart valve, the fingers deflect radially outward.   
     
     
         10 . The assembly of  claim 9 , wherein the slots extend longitudinally along the distal end portion of the second shaft and intersect a terminal distal end of the second shaft. 
     
     
         11 . The assembly of  claim 9 , wherein the fingers have distal ends that abut an adjacent end of the prosthetic heart valve. 
     
     
         12 . The assembly of  claim 9 , further comprising an introducer sheath and wherein the fingers can deflect radially inward when inserted through the introducer sheath. 
     
     
         13 . The assembly of  claim 9 , further comprising a nose cone including a plurality of nose cone fingers spaced apart from one another by a plurality of slots, the plurality of nose cone fingers configured to deflect radially outward when the balloon is inflated from the uninflated state to the inflated state. 
     
     
         14 . The assembly of  claim 9 , wherein the fingers flare from a first outer diameter at proximal ends of the fingers to a second, lager, diameter at distal ends of the fingers when the balloon is in the uninflated state. 
     
     
         15 . The assembly of  claim 9 , wherein the distal end portion of the second shaft has a first outer diameter proximal to the fingers and a second outer diameter at distal ends of the fingers, wherein the second outer diameter is greater than the first outer diameter when the balloon is in the uninflated state. 
     
     
         16 . A method, comprising:
 inserting a distal end portion of a delivery apparatus and a prosthetic heart valve into a patient's vasculature, the delivery apparatus comprising a first shaft; an inflatable balloon mounted on a distal end portion of the first shaft; and a second shaft extending coaxially over at least a portion of the first shaft and having a distal end portion comprising a plurality of fingers spaced apart from one another by a plurality of slots, wherein the prosthetic heart valve is mounted on the balloon in a crimped configuration;   advancing the distal end portion of the delivery apparatus and the prosthetic heart valve through the vasculature of the patient to a selected implantation site; and   inflating the balloon to radially the prosthetic heart valve from the crimped configuration to a radially expanded configuration, wherein inflating the balloon causes the plurality of fingers of the distal end portion of the second shaft to deflect radially outward from each other.   
     
     
         17 . The method of  claim 16 , wherein during advancing the distal end portion of the delivery apparatus and the prosthetic heart valve through the vasculature of the patient, the plurality of fingers abut an adjacent end of the prosthetic valve. 
     
     
         18 . The method of  claim 16 , wherein inserting the distal end portion of the delivery apparatus and the prosthetic heart valve into the patient's vasculature comprises inserting the distal end portion of the delivery apparatus and the prosthetic heart valve through an introducer sheath, which causes the plurality of fingers of the distal end portion of the second shaft to deflect radially inward. 
     
     
         19 . The method of  claim 16 , wherein during advancing the distal end portion of the delivery apparatus and the prosthetic heart valve through the vasculature of the patient, the plurality of fingers of the distal end portion of the second shaft extend over a portion of the balloon. 
     
     
         20 . The method of  claim 16 , wherein the slots intersect a terminal distal end of the second shaft.