HEART VALVE DELIVERY SYSTEM WITH VALVE CATHETER

• US 20150182334A1
• Filed: 12/04/2014
• Published: 07/02/2015
• Est. Priority Date: 10/18/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Bourang, Henry, Le, Thanh Huy, Taylor, David M., Sok, Sam, Evans, David J., Khanna, Rajesh A., Iobbi, Mario Gabriel
• Granted Patent: US 9,539,092 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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. 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 plurality of flexible extension arms disposed along a distal end portion of the valve catheter configured to hold the prosthetic valve during expansion of the prosthetic valve at a treatment site;

at least one tether for securing the prosthetic valve to the flexible extension arms; and

an actuation mechanism disposed along a proximal end portion of the valve catheter for causing the flexible extension arms to release the prosthetic valve.

2. The system of claim 1, 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 at least one tether from the prosthetic valve, thereby releasing the prosthetic valve from the flexible extension arms.

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

4. The system of claim 3, wherein the transition member comprises an inflatable balloon having a tapered distal end portion.

5. The system of claim 4, 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.

6. The system of claim 5, wherein the expandable frame of the prosthetic valve is balloon-expandable.

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

8. The system of claim 3, wherein the transition member comprises an expandable mechanical basket.

9. 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 tubular sleeve relative to the valve catheter.

10. 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 mop comprising a plurality of flexible extension arms disposed along a distal end portion of the valve catheter for engaging the prosthetic valve, the flexible extension arms configured to hold the prosthetic valve during expansion of the prosthetic valve at a treatment site;

at least one suture for securing the prosthetic valve to the flexible extension arms;

an actuation mechanism disposed along a proximal end portion of the valve catheter for causing the flexible extension arms to release the prosthetic valve; and

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 at least one suture from the prosthetic valve, thereby releasing the prosthetic valve from the flexible extension arms.

11. The system of claim 10, wherein the expandable frame of the prosthetic valve is balloon-expandable.

12. The system of claim 10, wherein the expandable frame of the prosthetic valve is self-expanding.

13. The system of claim 10, 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 tubular sleeve relative to the valve catheter.

14. The system of claim 10, wherein the slideable member is a wire.

15. The system of claim 10, wherein the valve catheter comprises a multi-lumen shaft.