Integrated heart valve delivery system

Abstract

Embodiments of the present disclosure provide a delivery apparatus for delivering a prosthetic heart valve to a native valve site via the human vasculature without the need for a separate introducer sheath. The delivery apparatus is particularly well-suited for advancing a prosthetic valve through the aorta (i.e., in a retrograde approach) for replacing a stenotic aortic valve.

We claim: 
     
         1 . A system for delivering a radially-compressible-and-expandable prosthetic heart valve through the vasculature of a patient, the system comprising a delivery device, the delivery device comprising:
 a proximal end and a distal end;   a handle disposed at the proximal end;   an elongate first shaft comprising a proximal end and a distal end, the proximal end of the first shaft coupled to the handle;   a tubular cover comprising a proximal end and a distal end, the proximal end of the cover coupled to the distal end of the elongate first shaft, the cover sized to receive therein a prosthetic heart valve in a radially compressed configuration, a diameter of the cover greater than a diameter of the first shaft;   an elongate second shaft slideably disposed within the first shaft, a proximal end of the second shaft extending out of a proximal end of the handle, a distal end of the second shaft extending out of the distal end of the first shaft, a distal end portion of the second shaft configured to carry the prosthetic valve in the radially compressed configuration; and   a nose piece comprising a proximal end and a distal end, the nose piece disposed at the distal end of the apparatus,   wherein the delivery device has
 a first state in which the first shaft is advanced relative to the second shaft such that the proximal end of the nose piece abuts the distal end of the cover, the nose piece and cover configured to completely enclose the prosthetic valve in the radially compressed configuration therein, and 
 a second state in which the first shaft is retracted relative to the second shaft, retracting the cover from the nose piece sufficiently to expose the prosthetic valve in the radially compressed configuration; and 
   wherein the system does not require a separate introducer sheath.   
     
     
         2 . The system of  claim 1 , wherein the delivery device further comprises a guide wire lumen extending longitudinally therethrough, the system further comprising a guide wire. 
     
     
         3 . The system of  claim 1 , wherein a maximum diameter of the cover and the nose piece is the maximum diameter of any portion of the delivery device configured for insertion into a patient. 
     
     
         4 . The system of  claim 1 , wherein the cover is sized to completely enclose a prosthetic valve in a radially compressed configuration. 
     
     
         5 . The system of  claim 1 , wherein an outer diameter of the cover is from about 0.260 inch to about 0.360 inch. 
     
     
         6 . The system of  claim 1 , wherein an outer diameter of the cover is about 0.223 inch. 
     
     
         7 . The system of  claim 1 , wherein the first shaft is a guide catheter, a distal end portion of the first shaft comprising a steerable section, wherein the delivery device further comprises a pull wire and an actuator, the actuator disposed on the handle, a first end of the pull wire coupled to the steerable section of the first catheter and a second end of the pull wire coupled to the actuator. 
     
     
         8 . The system of  claim 1 , wherein the handle comprises a locking mechanism configured for maintaining at least one relative longitudinal position between the first shaft and the second shaft. 
     
     
         9 . The system of  claim 1 , wherein the delivery device further comprises an elongate nose catheter extending through the second shaft, the nose piece disposed on a distal end of the nose catheter. 
     
     
         10 . The system of  claim 1 , further comprising a prosthetic valve, the prosthetic valve comprising a radially compressible and expandable stent portion supporting a valve structure. 
     
     
         11 . The system of  claim 10 , wherein the prosthetic valve is a prosthetic aortic valve. 
     
     
         12 . The system of  claim 10 , wherein the prosthetic valve is self-expanding. 
     
     
         13 . The system of  claim 12 , wherein the second shaft is a pusher. 
     
     
         14 . A method for implanting a prosthetic valve in a patient in need thereof, the method comprising:
 inserting into a vasculature of a patient a prosthetic valve in a radially compressed state, the prosthetic heart valve disposed at a distal end portion of an elongate delivery device, a nose piece and a cover of the delivery device completely enclosing the prosthetic heart valve;   advancing the prosthetic valve through the vasculature to an implantation site;   retracting the cover relative to the nose piece, thereby exposing the prosthetic valve;   expanding the prosthetic valve at the implantation site, thereby implanting the prosthetic valve; and   removing the delivery device from the vasculature of the patient,   wherein the prosthetic valve is inserted into the vasculature without using a separate introducer sheath.   
     
     
         15 . The method of  claim 14 , wherein advancing the prosthetic valve through the vasculature comprising advancing the prosthetic valve to a native aortic valve. 
     
     
         16 . The method of  claim 14 , wherein advancing the prosthetic valve through the vasculature comprises advancing the prosthetic valve over a guide wire. 
     
     
         17 . The method of  claim 14 , wherein expanding the prosthetic valve comprises allowing the prosthetic valve to self expand. 
     
     
         18 . The method of  claim 14 , wherein expanding the prosthetic valve comprises balloon expanding the prosthetic valve. 
     
     
         19 . The method of  claim 14 , wherein a maximum diameter of the cover and the nose piece is the maximum diameter of a portion of the delivery device that is inserted into the patient. 
     
     
         20 . The method of  claim 14 , further comprising retrieving the prosthetic valve back into the cover.