Transcatheter valve delivery systems and methods

• US 8,414,645 B2
• Filed: 08/27/2010
• Issued: 04/09/2013
• Est. Priority Date: 08/27/2009
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Dwork, Joshua, Macaulay, Patrick E., Pellegrini, Gianfranco M., Rinne, Finn O., Spork, Richard, Tran, Don Huy, Wiemeyer, Nathan B.
• Primary Examiner(s): TYSON, MELANIE RUANO
• Application Number:
  US12/870,567
• Publication Number:
  US 20110098805A1
• Time in Patent Office: 956 Days
• Field of Search: 623/2.11
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath

Abstract

Delivery devices and methods for percutaneously delivering a prosthetic valve to the heart of a patient. These prosthetic valves may be configured to provide complimentary features that promote optimal placement of the prosthetic valve in a native heart valve, such as the aortic valve, mitral valve, pulmonic valve, and/or tricuspid valve. The delivery device includes a release sheath assembly housed within an outer delivery sheath. A release sheath component of the assembly captures a portion of the prosthetic valve to the delivery device, and effectuates complete release of the prosthetic valve with retraction of the outer sheath.

Claims

1. A delivery device for percutaneously deploying a stented prosthetic heart valve including a stent frame to which a valve structure is attached, the device comprising:

a delivery sheath assembly terminating at a distal end and defining a lumen;

an inner shaft slidably disposed within the lumen;

a hub projecting from the inner shaft and configured to releasably receive a portion of a prosthetic heart valve stent frame; and

a release sheath assembly disposed between the delivery sheath assembly and the inner shaft, the release sheath assembly including a release sheath slidably disposed about the inner shaft;

wherein the delivery device is configured to provide a loaded state in which the delivery sheath assembly maintains a stented prosthetic heart valve over the inner shaft and coupled to the hub via the release sheath, and a deployment state in which the distal end of the delivery sheath assembly and the release sheath are withdrawn from the prosthetic heart valve to permit the prosthetic heart valve to release from the hub;

and further wherein the release sheath assembly is configured to self-retract the release sheath proximally relative to the hub as the distal end of the delivery sheath assembly is proximally retracted relative to the release sheath.

2. The delivery device of claim 1, wherein the release sheath forms at least one longitudinal notch extending from a distal end of the release sheath.

3. The delivery device of claim 2, wherein the at least one longitudinal notch includes a plurality of circumferentially spaced longitudinal notches.

4. The delivery device of claim 1, wherein the release sheath assembly further includes a mounting base connected to the release sheath by at least one biasing member.

5. The delivery device of claim 4, wherein the at least one biasing member is a leaf spring-like body having opposing, first and second ends, and further wherein the first end is fixed to the release sheath and the second end is fixed to the mounting base.

6. The delivery device of claim 4, wherein the mounting base is fixed to the inner shaft proximal the hub and proximal the release sheath.

7. The delivery device of claim 6, wherein the release sheath assembly is self-transitionable from a deflected state to a normal state, and further wherein a longitudinal spacing between the release sheath and the mounting base in the deflected state is greater than a spacing in the normal state, and further wherein the loaded state includes the release sheath assembly forced to the deflected state via the delivery sheath assembly, and even further wherein the delivery device is configured to transition to the deployment state as the distal end of the delivery sheath assembly is proximally retracted along the leaf spring-like body whereby the release sheath assembly is allowed to self-transition toward the normal state and retract the release sheath from the hub.

8. The delivery device of claim 7, wherein the release sheath assembly includes two biasing members interconnecting the release sheath and the mounting base.

9. The delivery device of claim 8, wherein an outer diameter collectively defined by the biasing members in the normal state is greater than a diameter of the lumen of the delivery sheath assembly.