TRANSCATHETER VALVE DELIVERY SYSTEMS AND METHODS

• US 20110098805A1
• Filed: 08/27/2010
• Published: 04/28/2011
• Est. Priority Date: 08/27/2009
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Rinne, Finn O., Macaulay, Patrick E., Wiemeyer, Nathan B., Pellegrini, Gianfranco M., Spork, Richard, Tran, Don Huy, Dwork, Joshua
• Granted Patent: US 8,414,645 B2
• Time in Patent Office: Days
• 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sheath, and a deployment state in which the distal end of the delivery sheath assembly and the release sheath are withdrawn from the prosthetic heart valve to permit the prosthetic heart valve to release from the hub.

2. The delivery device of claim 1, wherein the release sheath assembly is configured to proximally retract the release sheath relative to the hub with proximal retraction of the delivery sheath assembly distal end from the release sheath.

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

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

5. 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.

6. The delivery device of claim 5, wherein the at least one biasing member is a leaf spring-like body.

7. The delivery device of claim 5, wherein the mounting base is fixed to the inner shaft proximal the hub.

8. The delivery device of claim 7, 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.

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

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

11. A system for replacing a defective heart valve of a patient, the system comprising:

a prosthetic heart valve having a stent frame and a valve structure attached to the stent frame, the stent frame defining a distal region and a proximal region, the proximal region forming at least one post; and

a delivery 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 the at least one post,

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 system is configured to provide a loaded condition in which the prosthetic heart valve is retained between the delivery sheath assembly and the inner shaft, including the at least one post captured between the release sheath and the hub.

12. The system of claim 11, wherein the release sheath assembly is configured to proximally retract the release sheath relative to the hub with proximal retraction of the delivery sheath distal end from the release sheath.

13. The system of claim 11, wherein the release sheath assembly further includes a mounting base connected to the release sheath by at least one biasing member.

14. The system of claim 13, wherein the at least one biasing member is a leaf spring-like body.

15. The system of claim 13, wherein the mounting base is fixed to the inner shaft proximal the hub.

16. The system of claim 15, 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.

17. The system of claim 16, wherein the release sheath assembly includes two biasing members interconnecting the release sheath and the base.

18. The system of claim 17, wherein an outer diameter collectively defined by the biasing member in the normal state is greater than a diameter of the lumen of the delivery sheath assembly.

19. A method of percutaneously deploying a stented prosthetic heart valve to an implantation site of a patient, the method comprising:

receiving a delivery device loaded with a radially expandable prosthetic heart valve having a stent frame to which a valve structure is attached, the delivery device including a delivery sheath assembly containing the prosthetic heart valve in a compressed arrangement over an inner shaft in a loaded state of the device, a hub projecting from the inner shaft, and a release sheath assembly including a release sheath slidably capturing a post of the stent frame to the hub;

delivering the prosthetic heart valve in the compressed arrangement through a bodily lumen of the patient and to the implantation site via the delivery device in the loaded state;

proximally retracting the delivery sheath assembly from the prosthetic heart valve; and

permitting the post to release from the hub, including the release sheath assembly self-retracting the release sheath relative to the hub.

20. The method of claim 19, wherein proximally retracting the delivery sheath assembly includes locating a distal end of the delivery sheath assembly longitudinally between a distal end of the prosthetic heart valve and the release sheath in a partially deployed state such that a distal portion of the prosthetic heart valve is exposed, and further wherein the partially deployed state includes the exposed distal portion self-expanding from a compressed arrangement toward a normal arrangement, and a proximal portion of the prosthetic heart valve remains secured to the delivery device via capturing of the at least one post between the release sheath and the hub.

21. The method of claim 19, wherein the release sheath assembly further includes at least one biasing member connecting the release sheath with a mounting base.

22. The method of claim 21, wherein the mounting base is fixed to the inner shaft proximal the release sheath, and further wherein proximally retracting the delivery sheath assembly includes locating the distal end of the delivery sheath assembly proximal the release sheath such that the biasing member self-transitions toward a normal state and retracts the release sheath from the hub.