Heart valve delivery system with valve catheter

• US 9,539,092 B2
• Filed: 12/04/2014
• Issued: 01/10/2017
• Est. Priority Date: 10/18/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Khanna, Rajesh A., Bourang, Henry, Le, Thanh Huy, Taylor, David M., Sok, Sam, Iobbi, Mario Gabriel, Evans, David J.
• Primary Examiner(s): Anderson, Gregory
• Assistant Examiner(s): LAUER, CHRISTINA C
• Application Number:
  US14/561,113
• Publication Number:
  US 20150182334A1
• Time in Patent Office: 768 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, the prosthetic valve having a proximal end portion and a distal end portion;

a tubular sleeve defining a passageway;

a valve catheter disposed in the tubular sleeve;

a plurality of flexible extension arms coupled to a distal end portion of the valve catheter configured to hold the prosthetic valve, to radially expand with the prosthetic valve during expansion of the prosthetic valve at a treatment site, and to radially contract when relative movement between the sleeve and the valve catheter results in the sleeve being positioned over the flexible extension arms, causing the prosthetic valve to collapse from an expanded state to an at least partially collapsed state, wherein distal end portions of the flexible extension arms comprise attachment apertures and are releasably coupled to the proximal end portion of the prosthetic valve;

at least one tether extending through an attachment aperture of at least one flexible extension arm for securing the prosthetic valve to the flexible extension arms;

an actuation mechanism disposed along a proximal end portion of the valve catheter; and

at least one slidable member attached to the actuation mechanism and extending distally toward the prosthetic valve, wherein the slidable member is retractable upon actuation of the actuation mechanism for detaching the at least one tether from the prosthetic valve.

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

3. The system of claim 2, wherein the transition member comprises an inflatable balloon having a tapered distal end portion.

4. The system of claim 3, 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.

5. The system of claim 4, wherein the expandable frame of the prosthetic valve is balloon-expandable.

6. The system of claim 2, wherein the transition member comprises an expandable mechanical basket.

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

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

9. The system of claim 1, further comprising a plurality of tethers, and wherein the prosthetic valve includes a plurality of attachment openings circumferentially spaced relative to each other and aligned with the attachment apertures of the flexible extension arms, and each tether extends through a respective attachment opening of the prosthetic valve and through an attachment aperture of a respective flexible extension arm.

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

a prosthetic valve including a proximal end portion, a distal end portion, an expandable frame, a valvular structure, and a plurality of attachment openings circumferentially spaced relative to each other;

a tubular sleeve defining a passageway;

a valve catheter disposed in the tubular sleeve;

a mop comprising a plurality of flexible extension arms extending from a distal end portion of the valve catheter configured to hold the prosthetic valve, to radially expand with the prosthetic valve during expansion of the prosthetic valve at a treatment site, and to radially contract upon relative movement between the sleeve and the valve catheter that results in the sleeve being positioned over the flexible extension arms, causing the prosthetic valve to collapse from fully an expanded state to an at least partially collapsed state, wherein distal end portions of the flexible extension arms comprise attachment apertures that are releasably coupled to the proximal end portion of the prosthetic valve;

a plurality of tethers for securing the prosthetic valve to the flexible extension arms;

an actuation mechanism disposed along a proximal end portion of the valve catheter; and

at least one slidable member attached to the actuation mechanism and extending distally toward the prosthetic valve, wherein the slidable member is retractable upon actuation of the actuation mechanism for detaching the tethers from the prosthetic valve,

wherein the attachment openings of the prosthetic valve are aligned with the attachment apertures of the flexible extension arms, and each tether extends through a respective attachment opening of the prosthetic valve and through an attachment aperture of a respective flexible extension arm.

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 slidable member is a wire.

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

16. The system of claim 10, wherein the flexible extension arms comprise Nitinol.

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

a prosthetic valve including a proximal end portion, a distal end portion, an expandable frame, and a valvular structure;

a tubular sleeve defining a passageway;

a valve catheter disposed in the sleeve, the valve catheter and the sleeve configured to be advanced together through a body vessel to the heart;

a plurality of flexible extension arms coupled to a distal end portion of the valve catheter configured to hold the prosthetic valve, to radially expand with the prosthetic valve during expansion of the prosthetic valve at a treatment site, and to radially contract when relative movement between the sleeve and the valve catheter results in the flexible extension arms being disposed within the sleeve, causing the prosthetic valve to collapse from an expanded state to an at least partially collapsed state, wherein distal end portions of the flexible extension arms comprise attachment apertures and are releasably coupled to the proximal end portion of the prosthetic valve;

a plurality of release members extending through an attachment aperture of at least one flexible extension arm for securing the prosthetic valve to the flexible extension arms;

an actuation mechanism disposed along a proximal end portion of the valve catheter; and

at least one slidable member attached to the actuation mechanism and extending distally toward the prosthetic valve, wherein the slidable member is retractable upon actuation of the actuation mechanism to release the release members from the prosthetic valve.

18. The system of claim 17, wherein each release member extends through an attachment aperture of a respective extension arm.

19. The system of claim 18, wherein the prosthetic valve includes a plurality of attachment openings circumferentially spaced relative to each other and aligned with the attachment apertures of the flexible extension arms, each release member extending through a respective attachment opening of the prosthetic valve and through an attachment aperture of a respective flexible extension arm.

20. The system of claim 19, wherein the release members extend radially through the attachment apertures of the flexible extension arms and the attachment openings of the prosthetic valve.

21. The system of claim 17, wherein the flexible extension arms extend distally from a coupling element, and the coupling element is connected to the distal end portion of the valve catheter.

22. The system of claim 21, wherein a proximal end portion of the coupling element extends coaxially into an opening in the distal end portion of the valve catheter.