Heart valve delivery system

• US 7,780,723 B2
• Filed: 06/13/2005
• Issued: 08/24/2010
• 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 D
• Assistant Examiner(s): Price; Nathan R
• Application Number:
  US11/152,288
• Publication Number:
  US 20070005131A1
• Time in Patent Office: 1,898 Days
• Field of Search: 623/2.11, 623/1.11, 623/1.12, 623/900, 623/903, 623/904, 604/95.01, 604/95.04, 604/95.05, 604/171, 604/172, 604/510, 604523-528, 604/530
• 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 delivery system for 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 and handle. 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 openings in a slotted tube of the delivery sleeve assembly to close, thus causing the delivery sleeve assembly to bend. A stretchable cover is placed over the slotted tube for biasing the steerable catheter toward a straight position. Once advanced to the native valve site, the prosthetic valve is deployed by inflating the balloon.

Claims

1. A delivery system for deploying a prosthetic valve within a native aortic valve in a human heart, comprising:

a tubular sleeve;

a selectively steerable section permanently fixed to a distal end of the sleeve, the steerable section having a lumen with an inner diameter, the lumen communicating with an open distal end, the steerable section constructed to have a greater flexibility than the tubular sleeve;

a pull wire permanently fixed to a distal end portion of the steerable section for selectively controlling a curvature of the steerable section, the steerable section capable of achieving sufficient curvature to navigate around an aortic arch;

an elongate balloon catheter extending through the sleeve and through the lumen of the steerable section and out of the open distal end of the steerable section, the elongate balloon catheter being longitudinally movable relative to the sleeve and the steerable section; and

a prosthetic valve disposed over an expandable balloon along a distal end portion of the elongate balloon catheter, the prosthetic valve having an outer diameter larger than the inner diameter of the steerable section such that the prosthetic valve is prevented from moving proximally through the steerable section when the balloon is deflated and the prosthetic valve is in a radially compressed state on the deflated balloon, the prosthetic valve comprising an expandable stent portion and a valve structure;

wherein the sleeve, steerable section, balloon catheter and prosthetic valve are configured for advancement as a single unit through a patient'"'"'s vasculature while the prosthetic valve is positioned distal to the steerable section and wherein the balloon catheter and prosthetic valve are movable in a distal direction relative to the sleeve and steerable section for implanting the prosthetic valve within a native aortic valve.

2. The delivery system according to claim 1 wherein the sleeve further comprises first and second outer lumens extending along a side of the sleeve.

3. The delivery system according to claim 2 wherein the pull wire passes through the first outer lumen, through the steerable section to the distal end portion of the steerable section, and returns through the steerable section and through the second outer lumen.

4. The delivery system according to claim 1 wherein the steerable section comprises a slotted tube having a first straight position and a second curved position.

5. The delivery system according to claim 1 wherein the sleeve is formed of a polyether block amide and wherein the sleeve comprises a soft durometer polyether block amide near a distal end thereof.

6. The delivery system according to claim 3 wherein the pull wire is actuated by a rotational handle assembly, wherein the rotational handle assembly is located proximal to the sleeve.

7. The delivery system according to claim 1 wherein the distal end portion of the steerable section abuts a proximal end of the prosthetic valve.

8. The delivery system according to claim 1 further comprising a shroud coupled to the distal end portion of the steerable section and wherein the shroud surrounds at least a portion of the prosthetic valve during advancement through the patient'"'"'s vasculature.

9. The delivery system according to 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.

10. The delivery system of claim 1, wherein the pull wire has a proximal end portion connected to a handle mechanism, and a distal end portion connected to the steerable section, and wherein actuating the handle mechanism is effective to move the pull wire proximally to bend the steerable sector, while the sleeve undergoes substantially no deflection from the pull wire.