Delivery system for prosthetic heart valve

A method of implanting a radially compressible and expandable prosthetic heart valve in a native valve of the heart, the method comprising:

• introducing a delivery device into the body of a patient, the delivery device comprising a handle portion, an elongated shaft extending from and movable relative to the handle portion, the shaft comprising a proximal end portion coupled to the handle portion and a distal end portion mounting a prosthetic heart valve in a radially compressed state;
• advancing the distal end portion of the delivery device toward the native heart valve until the prosthetic valve is within or adjacent the aortic arch, wherein the act of advancing comprises pushing the handle portion distally so as to push the delivery device distally through the patient toward the native heart valve;
• steering the delivery device through the aortic arch by rotating a rotatable member of a steering assembly, the rotatable member being coupled to the handle portion, rotation of the rotatable member causing adjustment of a curvature of the elongated shaft;
• axially positioning the prosthetic heart valve at a desired implantation position by moving a grip portion of a lever member coupled to the handle portion, the lever member engaging a gear assembly operable to convert longitudinal motion of the lever member to rotational motion of the gear assembly, the gear assembly engaging the elongated shaft such that rotational motion of the gear assembly causes corresponding longitudinal motion of the elongated shaft relative to the handle portion, the grip portion of the lever member being movable proximally and distally of the rotatable member of the steering assembly;
• and
• after the prosthetic heart valve has been moved to the desired implantation position, radially expanding the prosthetic heart valve to engage the annulus of the native heart valve.

A delivery apparatus for implanting a radially compressible and expandable prosthetic heart valve in a native heart valve of the heart, the apparatus comprising:

• a handle portion;
• an elongated balloon catheter shaft extending from the handle portion, the balloon catheter shaft including a proximal end portion coupled to the handle portion and a distal end portion, the balloon catheter shaft further comprising a balloon mounted on the distal end portion and configured to mount a prosthetic heart valve in a radially compressed state;
• a steerable guide shaft disposed coaxially about the balloon catheter shaft and including a proximal end portion coupled to the handle portion and a distal end portion;
• a positioning assembly including a lever member coupled to the proximal end portion of the balloon catheter shaft and movable longitudinally with respect to the handle portion, the lever member engaging a gear assembly operable to convert longitudinal motion of the lever member to rotational motion of the gear assembly, the gear assembly engaging the balloon catheter shaft such that longitudinal motion of the lever member causes corresponding rotational motion of the gear assembly and longitudinal motion of the balloon catheter shaft with respect to the guide shaft and the handle portion, the lever member having a grip portion;
• a steering assembly including a rotatable member and a pull wire having a proximal end portion operatively connected to the rotatable member and a distal end portion fixed to the distal end portion of the guide shaft such that rotation of the rotatable member adjusts curvatures of the respective distal end portions of the guide shaft and the balloon catheter shaft;
• wherein the rotatable member of the steering assembly and the lever member of the positioning assembly are substantially co-located along a longitudinal axis of the balloon catheter shaft such that the grip portion of the lever member is movable distally and proximally of the rotatable member of the steering assembly by longitudinal motion of the control member and the rotatable member and the lever member are operable with one hand.