Prosthetic heart valve delivery system and method

1. A method for delivering a self-expanding prosthetic heart valve in a native valve annulus, the method comprising:

percutaneously introducing a prosthetic heart valve mounted on a distal end portion of a delivery apparatus into a patient's vasculature, the distal end portion of the delivery apparatus comprising a delivery sheath having a proximal end coupled to a distal end portion of an elongate, flexible torque shaft which extends into the vasculature, a second shaft extending between the torque shaft and the delivery sheath, the prosthetic heart valve mounted within the delivery sheath in a radially compressed state;

advancing the prosthetic heart valve through the vasculature to a proximity of a native valve;

positioning the prosthetic heart valve within a native valve annulus;

rotating the torque shaft in a first direction to retract the delivery sheath relative to the second shaft to expose the prosthetic heart valve;

allowing the prosthetic heart valve to radially self-expand in the native valve annulus, thereby delivering the self-expanding prosthetic heart valve;

releasing the expanded prosthetic heart valve from the delivery apparatus; and

removing the delivery apparatus from the patient.

2. The method of claim 1 , further comprising rotating the torque shaft in the first direction to retract the delivery sheath, rotating the torque shaft in a second direction opposite the first direction to advance the delivery sheath over the prosthetic heart valve; and repositioning the prosthetic heart valve in the native valve annulus.

3. The method of claim 1 , wherein percutaneously introducing the prosthetic heart valve into the patient's vasculature comprises inserting the entire length of the delivery sheath into the patient's vasculature.

4. A method for delivering a self-expanding prosthetic heart valve in a native valve annulus, the method comprising:

disposing a self-expanding prosthetic heart valve mounted on a distal end portion of a delivery device in a vasculature of a patient, the distal end portion of the delivery device comprising a delivery sheath, a proximal end portion of the delivery sheath coupled to a distal end portion of an elongate, flexible torque shaft which extends into the vasculature, the prosthetic heart valve within the delivery sheath in a radially compressed state, wherein the delivery device further comprises a second shaft through which the torque shaft extends, the proximal end of the delivery sheath being coupled to a distal end portion of the second shaft;

positioning the prosthetic heart valve within a native valve annulus;

rotating the torque shaft in a first direction relative to the second shaft and the delivery sheath to retract the delivery sheath relative to the second shaft to expose the prosthetic heart valve; and

allowing the prosthetic heart valve to radially self-expand in the native valve annulus, thereby delivering the self-expanding prosthetic heart valve.

5. The method of claim 4 , further comprising percutaneously introducing the prosthetic heart valve mounted on the distal end portion of the delivery device into a patient's vasculature.

6. The method of claim 5 , wherein percutaneously introducing the prosthetic heart valve comprises percutaneously introducing the prosthetic heart valve through a femoral artery.

7. The method of claim 5 , wherein percutaneously introducing the prosthetic heart valve comprises introducing the prosthetic heart valve through an introducer comprising an elongate tubular sleeve having a lumen, the sleeve comprising a metallic layer comprising a plurality of bands spaced along a length of the metallic layer and circumferentially extending openings interposed between adjacent bands.

8. The method of claim 4 , further comprising releasing the expanded prosthetic heart valve from the delivery device, and removing the delivery device from the patient.

9. The method of claim 8 , wherein releasing the prosthetic heart valve comprises releasing retaining arms of the prosthetic heart valve from a first fork and a second fork of the delivery device.

10. The method of claim 4 , further comprising rotating the torque shaft in the first direction to retract the delivery sheath, rotating the torque shaft in a second direction opposite the first direction to advance the delivery sheath over the prosthetic heart valve; and

repositioning the prosthetic heart valve in the native valve annulus.

11. The method of claim 4 , wherein rotating the torque shaft comprises rotating a control knob coupled to the torque shaft, the control knob disposed on a handle portion at a proximal end of the delivery device.

12. The method of claim 4 , wherein rotating the torque shaft comprises activating a motor disposed in a handle portion of the delivery device, the motor coupled to the torque shaft, the handle disposed at a proximal end of the delivery device.

13. The method of claim 4 , wherein rotating the torque shaft in a first direction to retract the delivery sheath comprises rotating a threaded portion of the torque shaft relative to a threaded portion of the delivery sheath engaged thereto.

14. The method of claim 4 , wherein the entire length of the delivery sheath is within the patient's vasculature during the acts of positioning, rotating, and allowing.