Delivery apparatus for prosthetic heart valve

1. A delivery apparatus for delivering a prosthetic heart valve to the heart of a patient for replacing a stenotic native aortic valve, the delivery apparatus comprising:

a handle;

a first shaft extending from the handle and movable axially relative to the handle;

a second shaft disposed around the first shaft and configured to extend into a patient, the second shaft terminating at a free distal end;

a third shaft extending from the handle coaxially through the second shaft;

a valve cover coupled to a distal end portion of the first shaft and configured to entirely house the prosthetic heart valve in a radially compressed state, and wherein the first shaft, the valve cover, and the third shaft are movable together in an axial direction relative to the second shaft;

wherein the second shaft has an outer diameter greater than an outer diameter of the first shaft and an outer diameter of the third shaft, wherein the free distal end of the second shaft is configured to be disposed adjacent the valve cover when the delivery apparatus is inserted into the patient;

wherein the valve cover is movable between a first state for covering the prosthetic valve during insertion into a patient's vasculature and a second state in which the valve cover uncovers the entirety of the prosthetic valve, and wherein the free distal end of the second shaft is proximal to a proximal end of the valve cover when the valve cover is in the first state and the second state; and

wherein the entirety of the valve cover has an outer diameter greater than an inner diameter of the second shaft when the valve cover is in the first state and the second state;

wherein the delivery apparatus has sufficient length for advancement over a guide wire through a femoral artery, an iliac artery, and around the aortic arch to the native aortic valve;

wherein the valve cover is flexible to enhance the ability of the delivery apparatus to follow the path of the guide wire as the delivery apparatus is advanced over the guide wire.

2. The delivery apparatus of claim 1 , in combination with a radially expandable and compressible prosthetic heart valve disposed within the valve cover in a radially compressed state, wherein a length of the valve cover is greater than a length of the prosthetic valve such that the valve cover extends over and contacts an outer surface of the prosthetic valve along an entire length of the prosthetic valve.

3. The delivery apparatus of claim 2 in combination with the prosthetic heart valve, wherein the first shaft and the valve cover are movable together relative to the second shaft to uncover the prosthetic heart valve.

4. A medical assembly, comprising:

a delivery apparatus, comprising:

a handle;

a first shaft extending from the handle and movable axially relative to the handle;

a second shaft disposed around the first shaft and configured to extend into a patient, the second shaft terminating at a free distal end,

a third shaft extending from the handle coaxially through the second shaft,

a valve cover coupled to a distal end portion of the first shaft and configured to entirely house a prosthetic heart valve in a radially compressed state, wherein the valve cover has an outer diameter greater than an inner diameter of the second shaft, and wherein the first shaft, the valve cover, and the third shaft are movable together in an axial direction relative to the second shaft, and

an inflatable balloon disposed on the distal end portion of the first shaft beneath the prosthetic heart valve; and

a radially expandable and compressible prosthetic heart valve disposed within the valve cover in a radially compressed state, a length of the valve cover being greater than a length of the prosthetic valve such that the valve cover extends over and contacts an outer surface of the prosthetic valve along an entire length of the prosthetic valve;

wherein the second shaft has an outer diameter greater than an outer diameter of the first shaft and an outer diameter of the third shaft, wherein the free distal end of the second shaft is configured to be disposed adjacent the valve cover when the delivery apparatus is inserted into the patient;

wherein the valve cover is movable between a first state for covering the prosthetic valve during insertion into a patient's vasculature and a second state in which the valve cover uncovers the prosthetic valve, and wherein the free distal end of the second shaft is proximal to a proximal end of the valve cover when the valve cover is in the first state;

wherein the first shaft and the valve cover are movable together relative to the second shaft to uncover the prosthetic heart valve; and

wherein the balloon is inflatable from a deflated configuration to an inflated configuration, thereby radially expanding the prosthetic heart valve from the radially compressed state to a radially expanded state.

5. The delivery apparatus of claim 3 in combination with the prosthetic heart valve, wherein the prosthetic heart valve is a self-expanding prosthetic heart valve that radially expands when advanced from the valve cover.

6. The delivery apparatus of claim 1 , wherein the second shaft comprises a steerable portion having an adjustable curvature.

7. The delivery apparatus of claim 6 , further comprising an adjustment mechanism coupled to the steerable portion and configured to adjust a curvature of the steerable portion.

8. The delivery apparatus of claim 6 , wherein the second shaft includes one or more pull wires extending along a length of the second shaft and coupling the steerable portion to an adjustment mechanism in the handle.

9. The delivery apparatus of claim 1 , wherein the first shaft defines an inner lumen through which a guide wire extends.

10. The delivery apparatus of claim 1 , wherein the second shaft cannot slide over the valve cover.

11. A medical assembly for replacing a stenotic native heart valve, comprising:

a delivery apparatus comprising:

a handle,

a first shaft extending from the handle, wherein the first shaft is movable axially relative to the handle,

a second shaft disposed around the first shaft and configured to extend into a patient;

a third shaft extending from the handle coaxially through the second shaft;

a valve cover coupled to a distal end portion of the first shaft, wherein the first shaft and the valve cover are movable together in an axial direction relative to the second shaft and the handle, wherein the third shaft is moveable in the axial direction relative to the second shaft, and wherein the second shaft has an outer diameter greater than an outer diameter of the first shaft and an outer diameter of the third shaft; and

a self-expanding prosthetic heart valve mounted in a radially compressed state within the valve cover for delivery through a patient's vasculature, the prosthetic heart valve comprising a radially compressible and expandable stent and a flexible valve structure mounted within the stent;

wherein the valve cover has a length that is greater than a length of the prosthetic valve such that the valve cover extends over an entirety of the prosthetic valve and an inner surface of a cylindrical section of the valve cover contacts an outer surface of the prosthetic valve to retain the prosthetic valve in the radially compressed state;

wherein the valve cover is movable between a first state for covering and retaining the prosthetic valve in the radially compressed state during insertion into a patient's vasculature and a second state in which the valve cover uncovers the entirety of the prosthetic valve and allows the prosthetic valve to radially expand, wherein a distal edge of the second shaft is proximal to and spaced axially apart from the valve cover in the first state and the second state; and

wherein the cylindrical section of the valve cover has a constant outer diameter greater than an inner diameter of the second shaft when the valve cover is in the first state and the second state;

wherein the delivery apparatus has sufficient length for advancement over a guide wire through a femoral artery, an iliac artery, and around the aortic arch to the native aortic valve;

wherein the valve cover is flexible to enhance the ability of the delivery apparatus to follow the path of the guide wire as the delivery apparatus is advanced over the guide wire.

12. The medical assembly of claim 11 , wherein the prosthetic heart valve is a self-expanding prosthetic heart valve that radially expands when advanced from the valve cover.

13. The medical assembly of claim 12 , wherein the first shaft and the valve cover are axially movable together relative to the second shaft to advance the prosthetic heart valve from the valve cover.

14. The medical assembly of claim 11 , wherein the second shaft comprises a steerable portion having an adjustable curvature.

15. The medical assembly of claim 11 , wherein the second shaft has a free distal end.

16. A delivery apparatus for implanting a prosthetic heart valve in a native aortic valve, comprising:

a handle;

a first shaft extending from the handle, wherein the first shaft is axially movable relative to the handle;

a second shaft disposed around the first shaft and configured to extend into a body of a patient, a distal end portion of the second shaft terminating at a free distal end of the second shaft, the distal end portion comprising a tubular member having a constant outer diameter including the free distal end;

a third shaft extending from the handle coaxially through the second shaft, the second shaft having an outer diameter greater than an outer diameter of the first shaft and an outer diameter of the third shaft; and

a valve cover coupled to a distal end portion of the first shaft and sized to fully cover a prosthetic heart valve in a radially compressed state, wherein the valve cover comprises nylon, has a length, and has a constant outer diameter that is greater than an inner diameter of the second shaft, and wherein the first shaft and the valve cover are movable together in an axial direction relative to the second shaft, wherein the third shaft is moveable in the axial direction relative to the second shaft, wherein the valve cover is movable between a first state for covering the prosthetic valve during insertion into a patient's vasculature and a second state in which the valve cover uncovers the entirety of the prosthetic valve, and wherein the free distal end of the second shaft is proximal to a proximal end of the valve cover when the valve cover is in the first state and the second state;

wherein the delivery apparatus is advanceable over a guide wire;

wherein an entirety of the valve cover is positioned distal to the free distal end of the second shaft during insertion into a patient's vasculature and wherein the valve cover is distally advanceable beyond the distal end portion of the second shaft toward the native aortic valve; and

wherein the prosthetic heart valve is releasable from the valve cover for implanting the prosthetic heart valve in the native aortic valve.

17. The delivery apparatus of claim 16 , wherein the prosthetic heart valve is a self-expanding prosthetic heart valve that radially expands when released from the valve cover.

18. The delivery apparatus of claim 16 , wherein the prosthetic heart valve is a balloon-expandable prosthetic heart valve.

19. The delivery apparatus of claim 16 , wherein the valve cover comprises a flexible material.

20. The delivery apparatus of claim 19 , wherein the valve cover has a wall thickness between 0.0015 inches and 0.015 inches.

21. A method of implanting a prosthetic valve using the apparatus of claim 1 , comprising:

introducing a distal end portion of the delivery apparatus and the prosthetic heart valve into a femoral artery of a patient while the valve cover in the first state and a proximal end of the valve cover is distal to the distal end of the second shaft, wherein the valve cover contacts the femoral artery during the act of introducing;

advancing the distal end portion of the delivery apparatus and the prosthetic heart valve to a selected implantation site; and

advancing the valve cover from the first state to the second state to uncover the prosthetic valve.