STAGED DEPLOYMENT DEVICES AND METHOD FOR TRANSCATHETER HEART VALVE DELIVERY

• US 20120123528A1
• Filed: 09/16/2011
• Published: 05/17/2012
• Est. Priority Date: 09/17/2010
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Inventors: Knippel, Bradley Charles, Wang, Huisun, Thomas, Ralph Joseph, Daly, Jacob John
• Granted Patent: US 8,778,019 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/9534 for repositioning of stents

Abstract

A delivery device for a collapsible heart valve includes an operating handle and a catheter assembly. The operating handle includes a frame defining a movement space therein, a carriage assembly moveable in a longitudinal direction within the movement space, and a coupler having locked and unlocked conditions, the coupler being operatively connected to the carriage assembly for movement therewith. The catheter assembly includes a shaft around which a valve-receiving compartment is defined, the shaft being operatively connected to one of the frame or the carriage assembly, and a distal sheath operatively connected to the carriage assembly for movement therewith between a closed condition adapted to maintain the valve in the compartment and an open condition adapted to fully deploy the valve.

Claims

1. A delivery device for a collapsible prosthetic heart valve, the delivery device comprising:

an operating handle, including;

a frame defining a movement space therein;

a carriage assembly moveable in a longitudinal direction within the movement space; and

a coupler having a locked condition in which the coupler is connected to the frame in a fixed position, and an unlocked condition in which the coupler is movable in the longitudinal direction within the movement space, the coupler being operatively connected to the carriage assembly for movement therewith; and

a catheter assembly, including;

a first shaft around which a compartment is defined, the first shaft being operatively connected to one of the frame or the carriage assembly, the compartment being adapted to receive the valve in an assembled condition; and

a distal sheath operatively connected to the carriage assembly, the distal sheath being moveable between a closed condition adapted to maintain the valve in the assembled condition and an open condition adapted to fully deploy the valve,

wherein movement of the carriage assembly in the longitudinal direction in the movement space moves the distal sheath between the closed condition and the open condition.

2. The delivery device of claim 1, wherein the coupler is selectively lockable to the frame in any of a plurality of fixed positions in the longitudinal direction.

3. The delivery device of claim 2, wherein the coupler includes a releasable pin and the frame has a plurality of fixed notches, the pin being engageable in one of the notches to lock the coupler to the frame.

4. The delivery device of claim 2, wherein the coupler is selectively lockable to the frame in positions that correspond to positions of the distal sheath between the closed condition and the open condition.

5. The delivery device of claim 1, wherein the operating handle further includes a threaded rod extending from the carriage assembly through the coupler, and a deployment actuator threadedly engaged with the threaded rod and longitudinally constrained relative to the coupler, such that rotation of the deployment actuator moves the carriage assembly in the longitudinal direction in the movement space.

6. The delivery device of claim 5, wherein rotation of the deployment actuator in a first direction moves the carriage assembly proximally in the longitudinal direction in the movement space, and rotation of the deployment actuator in a second direction opposite the first direction moves the carriage assembly distally in the longitudinal direction in the movement space.

7. The delivery device of claim 1, further comprising a latch mechanism adapted to releasably fix the coupler relative to the frame at any of a plurality of longitudinal positions in the movement space.

8. The delivery device of claim 1, wherein the operating handle further includes a resheathing lock having a locked position and an unlocked position, the resheathing lock in the locked position limiting movement of the carriage assembly in the longitudinal direction to a stop position in the movement space, and the resheathing lock in the unlocked position permitting movement of the carriage assembly beyond the stop position, wherein movement of the carriage assembly to the stop position moves the distal sheath to a condition between the closed condition and the open condition so that the valve is not fully deployed.

9. The delivery device of claim 8, wherein the frame includes a slot and the resheathing lock includes a retractable pin that is engaged in the slot when the resheathing lock is in the locked position, and a stop member located within the slot defines the stop position.

10. The delivery device of claim 9, wherein the stop member is longitudinally moveable within the slot, such that movement of the stop member changes the location of the stop position relative to the frame.

11. The delivery device of claim 8, wherein the compartment has a first length and the stop position in the movement space corresponds to a travel distance of the carriage assembly, the travel distance being less than the first length.

12. The delivery device of claim 11, wherein the collapsible prosthetic heart valve has a second length and the travel distance is between about 80% and about 90% of the second length.

13. The delivery device of claim 1, wherein the first shaft is operatively connected to the frame, the catheter assembly further including an outer shaft connecting the carriage assembly to the distal sheath and at least partially surrounding the first shaft.

14. The delivery device of claim 1, wherein the first shaft is operatively connected to the frame, and the operating handle further includes a mechanism adapted to move the first shaft proximally relative to the frame.

15. The delivery device of claim 14, wherein the mechanism includes a threaded rod operatively connected to the first shaft and extending in the longitudinal direction, and a nut threadedly engaged with the threaded rod and longitudinally constrained relative to the frame.

16. The delivery device of claim 1, wherein the first shaft is operatively connected to the carriage assembly, the catheter assembly further including an outer shaft connecting the frame to the compartment and at least partially surrounding the first shaft.

17. The delivery device of claim 1, wherein the first shaft is operatively connected to the carriage assembly, and the operating handle further includes a mechanism adapted to move the first shaft proximally relative to the carriage assembly.

18. The delivery device of claim 17, wherein the mechanism includes a threaded rod operatively connected to the first shaft and extending in the longitudinal direction, and a nut threadedly engaged with the threaded rod and longitudinally constrained relative to the carriage assembly.

19. A method of delivering a collapsible prosthetic heart valve in a patient, the method comprising:

providing a delivery device having a catheter assembly and an operating handle, the catheter assembly including a compartment adapted to receive the valve in an assembled condition, the operating handle including a frame defining a movement space therein, a carriage assembly moveable in a longitudinal direction within the movement space, and a coupler operatively connected to the carriage assembly for movement therewith;

loading the valve into the compartment of the catheter assembly, the compartment and the valve being covered by a distal sheath of the catheter assembly;

inserting the catheter assembly into the patient;

positioning the valve at a target location within the patient;

partially deploying the valve by moving the carriage assembly of the operating handle in a first longitudinal direction along a first portion of the movement space; and

fully deploying the valve by translating the coupler of the operating handle to continue movement of the carriage assembly in the first longitudinal direction along a second portion of the movement space.

20. The method of claim 19, wherein the operating handle further includes a threaded rod extending from the carriage assembly through the coupler, and a deployment actuator threadedly engaged with the threaded rod and longitudinally constrained relative to the coupler, and the partially deploying step includes rotating the deployment actuator.

21. The method of claim 19, wherein the operating handle further includes a resheathing lock having a locked position and an unlocked position, the resheathing lock in the locked position limiting movement of the carriage assembly in the longitudinal direction to a stop location in the movement space, the resheathing lock in the unlocked position permitting movement of the carriage assembly beyond the stop location, the method further comprising adjusting a position of the resheathing lock in the longitudinal direction to set the stop location in the movement space.

22. The method of claim 19, further comprising resheathing the valve by moving the carriage assembly in a second longitudinal direction opposite the first longitudinal direction.

23. The method of claim 19, wherein the catheter assembly further includes a first shaft around which the compartment is defined and an outer shaft connecting the carriage assembly to the distal sheath and at least partially surrounding the first shaft, the first shaft is operatively connected to the frame, the distal sheath is operatively connected to the carriage assembly, and the steps of partially deploying the valve and fully deploying the valve each include moving the outer shaft proximally relative to the frame.

24. The method of claim 22, wherein the catheter assembly further includes a first shaft around which the compartment is defined, the first shaft is operatively connected to the frame, the distal sheath is operatively connected to the carriage assembly, and the resheathing step includes moving the first shaft proximally relative to the frame and the distal sheath.

25. The method of claim 24, wherein the operating handle further includes a threaded rod operatively connected to the first shaft and extending in the longitudinal direction, and a nut threadedly engaged with the threaded rod and longitudinally constrained relative to the frame, and the step of moving the first shaft includes rotating the nut about the threaded rod.

26. The method of claim 24, wherein the operating handle further includes a resheathing lock having a locked position and an unlocked position, the resheathing lock in the locked position limiting movement of the carriage assembly in the longitudinal direction to a stop location in the movement space, the resheathing lock in the unlocked position permitting movement of the carriage assembly beyond the stop location, and the step of moving the first shaft is performed with the resheathing lock in the locked position.

27. The method of claim 19, wherein the catheter assembly further includes a first shaft around which the compartment is defined and an outer shaft connecting the frame to the compartment and at least partially surrounding the first shaft, the first shaft and the distal sheath are operatively connected to the carriage assembly, and the steps of partially deploying the valve and fully deploying the valve each include moving the first shaft distally relative to the frame.

28. The method of claim 22, wherein the catheter assembly further includes a first shaft around which the compartment is defined, the first shaft and the distal sheath are operatively connected to the carriage assembly, and the resheathing step includes moving the first shaft proximally relative to the carriage assembly.

29. The method of claim 28, wherein the operating handle further includes a threaded rod operatively connected to the first shaft and extending in the longitudinal direction, and a nut threadedly engaged with the threaded rod and longitudinally constrained relative to the carriage assembly, and the step of moving the first shaft includes rotating the nut about the threaded rod.

30. The method of claim 28, wherein the operating handle further includes a resheathing lock having a locked position and an unlocked position, the resheathing lock in the locked position limiting movement of the carriage assembly in the longitudinal direction to a stop location in the movement space, the resheathing lock in the unlocked position permitting movement of the carriage assembly beyond the stop location, and the step of moving the first shaft is performed with the resheathing lock in the locked position.

31. The method of claim 19, wherein the target location within the patient is the native aortic annulus of the patient.

32. The method of claim 19, wherein the distal sheath of the delivery device is inserted through a femoral artery of the patient.

33. The method of claim 19, wherein the distal sheath of the delivery device is inserted through the apex of the heart of the patient.