Heart valve delivery system with valve catheter

• US 20070088431A1
• Filed: 10/18/2005
• Published: 04/19/2007
• Est. Priority Date: 10/18/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Taylor, David, Khanna, Rajesh, Bourang, Henry, Sok, Sam, Iobbi, Mario, Le, Thanh, Evans, Dave
• Granted Patent: US 8,167,932 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve

Abstract

A heart valve delivery system is provided wherein a prosthetic valve is carried on a valve catheter inside a delivery sleeve. A step balloon protrudes from the delivery sleeve and provides a tapered surface for facilitating advancement through a body vessel. The step balloon also aids in crossing the leaflets of a native valve. After the prosthetic valve is positioned within the native valve, the delivery sleeve is retracted to expose the prosthetic valve. In one embodiment, the delivery sleeve is retracted by the use of a lead screw, which effectuates relative movement between the valve catheter and delivery sleeve. The prosthetic valve is preferably self-expandable. If necessary, the step balloon may be expanded to securely seat the prosthetic valve at the site of the native valve. The prosthetic valve is preferably coupled to the valve catheter by a plurality of flexible extension arms which allow the prosthetic valve to be collapsed after initial deployment such that the prosthetic valve may be repositioned if necessary.

Claims

1. A system for treating a native valve in a human heart, comprising:

a prosthetic valve including an expandable frame and a valvular structure;

a tubular sleeve defining a passageway extending therethrough;

a valve catheter configured for slidable advancement through the passageway of the tubular sleeve;

a releasable engagement mechanism disposed along a distal end portion of the valve catheter for engaging the prosthetic valve; and

an actuation mechanism disposed along a proximal end portion of the valve catheter for causing the releasable engagement mechanism to release the prosthetic valve.

2. The system of claim 1, wherein the releasable engagement mechanism comprises a plurality of flexible extension arms configured to hold the prosthetic valve during expansion of the prosthetic valve at a treatment site.

3. The system of claim 2, further comprising at least one suture for securing the prosthetic valve to the flexible extension arms.

4. The system of claim 3, further comprising at least one slidable member attached to the actuation mechanism and extending distally toward the prosthetic valve, wherein the slidable member is retractable for detaching the suture from the prosthetic valve, thereby releasing the prosthetic valve from the flexible extension arms.

5. The system of claim 1, further comprising an expandable transition member extending from a distal end of the tubular sleeve.

6. The system of claim 5, wherein the transition member comprises an inflatable balloon having a tapered distal end portion.

7. The system of claim 6, wherein the inflatable balloon is disposed at least partially within the prosthetic valve and wherein inflation of the inflatable balloon facilitates expansion of the prosthetic valve.

8. The system of claim 7, wherein the expandable frame of the prosthetic valve is balloon-expandable.

9. The system of claim 1, wherein the expandable frame of the prosthetic valve is self-expanding.

10. The system of claim 5, wherein the transition member comprises an expandable mechanical basket.

11. The system of claim 1, further comprising a handle assembly having a distal end portion attached to the tubular sleeve and a proximal end portion attached to the valve catheter, the handle assembly being adjustable for controllably retracting the delivery sleeve relative to the valve catheter.

12. A method of deploying a prosthetic valve within a native valve in a human heart, comprising:

providing an elongate valve catheter having a releasable attachment mechanism along a distal end portion;

attaching the prosthetic valve to the releasable attachment mechanism;

placing the valve catheter and prosthetic valve in a tubular sleeve;

advancing the tubular sleeve, valve catheter and prosthetic valve through a femoral artery and over an aortic arch until the prosthetic valve is located within the native valve;

retracting the delivery sleeve relative to the valve catheter to expose the prosthetic valve; and

actuating an actuation mechanism on a proximal end of the valve catheter to release the prosthetic valve from the valve catheter.

13. The method of claim 12, further comprising providing an inflatable balloon within the prosthetic valve, wherein a tapered distal end portion of the inflatable balloon extends from the tubular sleeve for providing a dilator.

14. The method of claim 12, further comprising providing an inflatable balloon within the prosthetic valve and inflating the balloon after retracting the tubular sleeve to facilitate expansion of the prosthetic valve.

15. The method of claim 12, further comprising advancing the tubular sleeve relative to the valve catheter to collapse and reposition the prosthetic valve and then retracting the delivery sleeve again before releasing the prosthetic valve from the valve catheter.

16. A device for treating a human heart, comprising:

a prosthetic valve;

a tubular delivery sleeve having a proximal end;

a lead screw nut coupled to the proximal end of the tubular delivery sleeve;

a valve catheter having a distal end configured for releasable attachment to the prosthetic valve, wherein the valve catheter and the prosthetic valve are slidably advanceable through the delivery sleeve; and

a lead screw coupled to the valve catheter;

wherein the lead screw engages the lead screw nut and wherein rotation of the lead screw causes the valve catheter and the prosthetic valve to advance relative to the delivery sleeve.

17. The device of claim 16, further comprising an inflatable balloon disposed within the prosthetic valve for facilitating expansion of the prosthetic valve within the native valve.

18. The device of claim 17, wherein the inflatable balloon has a tapered distal end portion configured to extend from the tubular delivery sleeve for providing a dilator.

19. The device of claim 16, wherein the tubular delivery sleeve is coated with a hydrophilic coating.

20. The device of claim 16, further comprising a plurality of flexible extensions disposed along the distal end of the valve catheter, the flexible extension being configured for releasable attachment to the prosthetic valve.