Heart valve delivery system with valve catheter

• US 8,167,932 B2
• Filed: 10/18/2005
• Issued: 05/01/2012
• Est. Priority Date: 10/18/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Bourang, Henry, Taylor, David M., Sok, Sam, Iobbi, Mario, Khanna, Rajesh, Le, Thanh Huy, Evans, Dave J.
• Primary Examiner(s): McDermott, Corrine M
• Assistant Examiner(s): LAUER, CHRISTINA C
• Application Number:
  US11/252,657
• Publication Number:
  US 20070088431A1
• Time in Patent Office: 2,387 Days
• Field of Search: 606/200, 606/213, 606/108, 606/198, 623/2.11, 623/1.24, 623/1.26, 623/1.3, 623/1.31, 623/1.11, 623/1.12
• US Class Current: 623/2.11
• 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 self-expandable 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 secured to a distal end portion of the valve catheter, each flexible extension arm extending distally from the valve catheter, and each flexible extension arm comprising a distal end for engaging only a proximal end portion of the prosthetic valve, the flexible extension arms configured to stabilize the prosthetic valve during expansion at a treatment site, the distal end of each flexible extension arm comprising at least one opening extending transversely therethrough;

a plurality of wires slidably disposed in the valve catheter, each wire comprising a proximal end and a distal end;

at least one suture, a loop of which extends through the at least one opening in the flexible extension arm and around the distal end of a corresponding wire when securing the proximal end of the prosthetic valve to the flexible extension arms, and released from the distal end of the wire when releasing the proximal end of the prosthetic valve from the flexible extension arms; and

an actuation mechanism disposed along a proximal end portion of the valve catheter, the actuation mechanism coupled to the proximal ends of the plurality of wires and configured to slide the wires proximally within the valve catheter, thereby detaching the suture from the prosthetic valve while the suture remains intact, thereby releasing the prosthetic valve from the flexible extension arms.

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 suture from the prosthetic valve.

3. The system of claim 2, wherein the wherein the actuation mechanism allows the prosthetic valve to be released from the flexible extension arms by the prosthetic valve sliding relatively distally away from the tether and the flexible extension arms while the tether is intact.

4. The system of claim 3, wherein the prosthetic valve is detached from the suture and from the extension arms by sliding the slidable member relative to the prosthetic valve.

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 expandable mechanical basket, the expandable mechanical basket configured to be removed from a patient'"'"'s body after expansion of the prosthetic valve at the treatment site.

7. The system of claim 5, wherein the transition member comprises an inflatable balloon that extends within the prosthetic valve and extends distally beyond a distalmost extent of the prosthetic valve.

8. The system of claim 5, wherein the transition member comprises an inflatable balloon having a tapered distal end portion forming at least one conical region.

9. The system of claim 8, wherein

the inflatable balloon comprises a first cylindrical region and a second cylindrical region distal of the first cylindrical region,

an expanded diameter of the first cylindrical region is greater than an expanded diameter of the second cylindrical region,

the expanded diameter of the first cylindrical region is dimensioned for engaging and expanding the prosthetic valve, and

the expanded diameter of the second cylindrical region is dimensioned for dilating stenotic leaflets of a native heart valve.

10. The system of claim 8, wherein the inflatable balloon is configured to be disposed at least partially within the prosthetic valve and wherein inflation of the inflatable balloon facilitates expansion of the prosthetic valve.

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 tubular sleeve relative to the valve catheter.

12. The system of claim 11, wherein the handle assembly includes a threaded portion.

13. The system of claim 1, wherein the flexible extension arms are formed of a shape memory material.

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

an expandable 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, each flexible extension arm extending distally from the valve catheter, each flexible extension arm comprising a distal end that engages a proximal end portion of the prosthetic valve, the distal end of each flexible extension arm comprising a pair of openings extending transversely therethrough;

at least one suture, loops of which extend through the pair of openings of the each flexible extension arm when securing the prosthetic valve to the flexible extension arms; and

an actuation mechanism disposed along a proximal end portion of the valve catheter, the actuation mechanism configured to detach the suture from the prosthetic valve, thereby releasing the prosthetic valve from the flexible extension arms,

wherein the actuation mechanism comprises at least one slidable member positioned between the suture and the valve, wherein when the slidable member is slid relative to the valve, the suture detaches from the prosthetic valve.

15. The system of claim 14, wherein when the slidable member is slid relative to the valve, the suture detaches from the prosthetic valve while the suture remains intact.