Method of delivering a prosthetic heart valve

• US 8,382,826 B2
• Filed: 08/12/2010
• Issued: 02/26/2013
• Est. Priority Date: 06/13/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Taylor, David M.
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): Price, Nathan R
• Application Number:
  US12/855,378
• Publication Number:
  US 20110054596A1
• Time in Patent Office: 929 Days
• Field of Search: 623/1.11, 623/1.12, 623/2.11, 623/900, 623/903, 623/904, 604/509, 604/510
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61M 25/0138 having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires

Abstract

A method of delivering a prosthetic heart valve to a native valve site within the human vasculature. The prosthetic valve is disposed on a balloon at the end of a balloon catheter. The balloon catheter passes through a delivery sleeve assembly. A pull wire travels from the handle to a distal end of the delivery sleeve assembly. Actuation of the handle pulls on the pull wire, which causes the delivery sleeve assembly to bend for facilitating navigation through a patient'"'"'s vasculature. A stretchable cover is preferably placed over the slotted tube for biasing the steerable catheter toward a straight position. Once advanced to the vicinity of the native valve site, the prosthetic valve may be accurately positioned by advancing the balloon catheter relative to the delivery sleeve assembly and then deployed within the native valve site by inflating the balloon. In an alternative embodiment, the delivery sleeve assembly may be used to advance a self-expanding prosthetic heart valve through a patient'"'"'s vasculature and a pusher member may be used to eject the prosthetic valve at the native valve site.

Claims

1. A method of deploying a prosthetic valve within a native aortic valve in a human heart, the prosthetic valve comprising a radially compressible and expandable metallic stent and a flexible valvular structure mounted within the stent, the method comprising:

providing a delivery system comprising a tubular sleeve and a selectively steerable section permanently attached to a distal end of the tubular sleeve, the delivery system further comprising a balloon catheter extending through a central lumen in the tubular sleeve and the steerable section and wherein a distal end portion of the balloon catheter is positioned distal to a distal end of the steerable section;

crimping the prosthetic valve along the distal end portion of the balloon catheter such that the prosthetic valve is positioned distal to the distal end of the steerable section;

advancing the prosthetic valve, balloon catheter, tubular sleeve and steerable section through a femoral artery and an aortic arch;

actuating a pull wire for selectively controlling a curvature of the steerable section during advancement around the aortic arch, the pull wire having a distal end portion permanently fixed to the steerable section;

distally advancing the balloon catheter and prosthetic valve relative to the tubular sleeve and steerable section for positioning the prosthetic valve within the native aortic valve; and

radially expanding the prosthetic valve by inflating a balloon disposed along the distal end portion of the balloon catheter.

2. The method of claim 1, wherein the steerable section is formed with a material having a soft durometer for facilitating flexing of the steerable section.

3. The method of claim 1, wherein the pull wire is actuated by a rotatable handle assembly and wherein the rotatable handle assembly is located proximal to the tubular sleeve.

4. The method of claim 1, wherein the distal end of the steerable section abuts a proximal end of the prosthetic valve for pushing the prosthetic valve during advancement of the prosthetic valve through the femoral artery and the aortic arch.

5. The method of claim 1, further comprising a shroud coupled to the distal end of the steerable section and wherein the shroud surrounds at least a portion of the prosthetic valve during advancement of the prosthetic valve through the femoral artery and the aortic arch.

6. The method of claim 1, wherein the steerable section comprises a flexible tubular portion and a cover extending over at least a portion of the tubular portion, the cover being less flexible than the tubular portion.

7. The method of claim 1, wherein the pull wire has a proximal end portion connected to a handle mechanism and wherein actuating the handle mechanism pulls the pull wire proximally to bend the steerable section.

8. A method of deploying a prosthetic valve within a stenotic native aortic valve, the prosthetic valve comprising a radially compressible and expandable metallic stent and a flexible valvular structure mounted within the stent, the method comprising:

providing a delivery system comprising a tubular sleeve and a selectively steerable section attached to a distal end of the tubular sleeve, the delivery system further comprising a balloon catheter extending through a lumen defined by the tubular sleeve and the steerable section, wherein a distal end portion of the balloon catheter is located distal to a distal end of the steerable section;

crimping the prosthetic valve along the distal end portion of the balloon catheter such that the prosthetic valve is positioned distal to the distal end of the steerable section;

pre-dilating leaflets of the native aortic valve for increasing the flow area through the native aortic valve;

advancing the prosthetic valve, balloon catheter, tubular sleeve and steerable section through a femoral artery and an aortic arch;

actuating a pull wire for selectively controlling a curvature of the steerable section during advancement around the aortic arch, the pull wire having a distal end portion fixed to the steerable section;

advancing the balloon catheter and prosthetic valve relative to the tubular sleeve and steerable section for positioning the prosthetic valve within the native aortic valve; and

radially expanding the prosthetic valve by inflating a balloon disposed along the distal end portion of the balloon catheter.

9. The method of claim 8, wherein the steerable section comprises elongate openings.

10. The method of claim 9, wherein the elongate openings are formed by laser cutting.

11. The method of claim 8, wherein the steerable section comprises a stainless steel hypo-tube.

12. The method of claim 8, wherein pre-dilating the leaflets of the native aortic valve is performed by expanding an expandable balloon within the native aortic valve.