Heart valve delivery system

• US 20070005131A1
• Filed: 06/13/2005
• Published: 01/04/2007
• Est. Priority Date: 06/13/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Taylor, David
• Granted Patent: US 7,780,723 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• 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, comprising:

a tubular sleeve;

a selectively steerable section coupled to a distal end of the sleeve;

an elongate balloon catheter extending through 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;

wherein the sleeve, steerable section, balloon catheter and prosthetic valve are configured for advancement as an single unit through a patient'"'"'s vasculature and wherein the prosthetic valve is adjacent a distal end portion of the steerable section.

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 a 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 prosthetic valve is located distal to the steerable section such that 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. A delivery system, comprising:

a delivery sleeve assembly having a main lumen;

a slotted tube forming a steerable section of the delivery sleeve assembly, the steerable section having a first configuration wherein the steerable section is substantially straight and a second configuration wherein the steerable section is curved, wherein the steerable section is enveloped by a covering, wherein the covering is stretchable such that it biases the steerable section from the second configuration to the first configuration; and

an elongate balloon catheter extending through the main lumen of the delivery sleeve assembly, wherein a prosthetic valve is mounted to a balloon located at a distal end of the balloon catheter.

10. The delivery system according to claim 9 wherein the cover comprises a soft durometer polyether block amide.

11. The delivery system according to claim 9 wherein the steerable section is acted upon by a pull wire which is actuated by a rotator handle which is mounted to a proximal end of the delivery sleeve assembly.

12. The delivery system according to claim 9 wherein the prosthetic valve is placed distal to the steerable section.

13. The delivery system according to claim 9 wherein the prosthetic valve is placed inside a shroud which is located distal to the steerable section and comprises a distal portion of the delivery sleeve assembly.

14. A method of delivering a prosthetic valve to a native valve site of a patient, comprising:

mounting a prosthetic valve over a balloon on a balloon catheter;

placing the balloon catheter inside a delivery sleeve assembly having a steerable section which is actuated by a pull wire running along the length of the delivery sleeve assembly and attached to a moving member of a handle;

tracking the prosthetic valve to the native valve site by pushing the valve through iliac and femoral arteries of the patient, over an aortic arch, and to the native valve site, whereby the moving member pulls the pull wire when the handle is rotated in a first direction, causing the steerable section to bend, and whereby the moving member releases the pull wire when the handle is rotated in a second direction, allowing the rigidity of the delivery sleeve assembly to straighten the steerable section; and

inflating the balloon to deploy the prosthetic valve at the native valve site.

15. The method according to claim 14 and further comprising pushing through hardened leaflets of the native valve site while the steerable section is bent.

16. The method according to claim 14 and further comprising distally advancing the balloon catheter relative to the delivery sleeve assembly until the prosthetic valve is located within the native valve site

17. The method according to claim 14 wherein the prosthetic valve comprises a stent portion supporting a valve structure.

18. The method according to claim 17 wherein an outer surface of the stent is substantially exposed during advancement over the aortic arch.

19. The method according to claim 18 wherein a distal end of the steerable section abuts a proximal end of the stent portion while tracking the prosthetic valve to the native valve site.

20. A method of delivering a prosthetic valve to a native valve site of a patient, comprising:

disposing an expandable prosthetic valve over a balloon along a distal end portion of a balloon catheter;

placing the balloon catheter inside a delivery sleeve assembly having a steerable section which is actuated by a pull wire;

advancing the prosthetic valve and delivery sleeve assembly toward the native valve site substantially as a single unit while selectively adjusting the curvature of the steerable section to facilitate advancement;

advancing the prosthetic valve out of the delivery sleeve assembly and into the native valve site; and

inflating the balloon to deploy the prosthetic valve at the native valve site.