TRANSCATHETER DELIVERY SYSTEM WITH TRANSVERSE WHEEL ACTUATION

• US 20180153693A1
• Filed: 11/30/2017
• Published: 06/07/2018
• Est. Priority Date: 12/02/2016
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Inventors: Copeland, David John, Beckerle, Travis Michael, Gordon, Joseph, Frohman, Bruce Edward, Metz, Michael William, Kyle, Savannah Grace, Hill, Kelsey, Morrissey, Michael Shane
• Granted Patent: US 10,631,986 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type

Abstract

A delivery device for a collapsible prosthetic heart valve, the delivery device including an inner shaft, a distal sheath disposed about a portion of the inner shaft and forming a compartment with the inner shaft, the compartment adapted to receive the valve, the inner shaft and the distal sheath being movable relative to one another, and a handle including a frame having a longitudinal axis, a proximal end and a distal end, the handle including a deployment actuator and a hub, the deployment actuator and the hub being independently capable of opening and closing the compartment, a resheathing lock configured to alert a user of a position of the distal sheath and to impede movement of the distal sheath, and an indicator disposed on the frame and capable of showing an extent of deployment of the valve.

Claims

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

an inner shaft;

a distal sheath disposed about a portion of the inner shaft and forming a compartment with the inner shaft, the compartment being adapted to receive the prosthetic heart valve, the inner shaft and the distal sheath being movable relative to one another; and

a handle including a frame having a longitudinal axis, a proximal end and a distal end, the handle further including a deployment actuator and a hub, each of the deployment actuator and the hub being independently capable of opening and closing the compartment, a resheathing lock configured to alert a user of a position of the distal sheath and to impede movement of the distal sheath, and an indicator disposed on the frame and capable of showing an extent of deployment of the prosthetic heart valve.

2. The delivery device of claim 1, wherein the deployment actuator includes a wheel having an axis of rotation disposed transverse to the longitudinal axis of the frame.

3. The delivery device of claim 1, wherein the deployment actuator is capable of longitudinally translating the distal sheath to cover or uncover the compartment.

4. The delivery device of claim 1, wherein the hub is disposed adjacent the proximal end of the frame and is capable of longitudinally translating the inner shaft to cover or uncover the compartment.

5. The delivery device of claim 1, further including a carriage assembly having a first gear, a second gear and a threaded rod, the first gear and the second gear being arranged to convert rotation of the deployment actuator into translation of the threaded rod along the longitudinal axis of the frame.

6. The delivery device of claim 1, wherein the delivery device is configured and arranged for use in a transfemoral delivery approach.

7. The delivery device of claim 1, wherein the delivery device is configured and arranged for use in a transapical delivery approach.

8. The delivery device of claim 1, wherein the resheathing lock includes a pin having a first position in which the pin is disposed within the frame, and a second position in which the pin protrudes from the frame.

9. The delivery device of claim 8, wherein the predetermined position is a position at which the prosthetic heart valve has been partially deployed so that any further withdrawing of the distal sheath would result in the prosthetic heart valve being incapable of being resheathed.

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

an inner shaft;

a distal sheath disposed about a portion of the inner shaft and forming a compartment with the inner shaft, the compartment being adapted to receive the prosthetic heart valve, the inner shaft and the distal sheath being movable relative to one another; and

a handle including a frame having a longitudinal axis, a proximal end and a distal end, the handle further including a deployment actuator and a hub, each of the deployment actuator and the hub being independently capable of opening and closing the compartment.

11. The delivery device of claim 10, further comprising a resheathing lock configured to visually alert a user of a predetermined position of the outer shaft and to impede movement of the distal sheath.

12. The delivery device of claim 11, wherein the resheathing lock includes a pin having a first position in which the pin is disposed within the frame, and a second position in which the pin protrudes from the frame.

13. The delivery device of claim 12, wherein the resheathing lock is configured to be pressed by the user to allow movement of the outer shaft.

14. The delivery device of claim 10, further comprising an indicator disposed on the frame and capable of showing an extent of deployment of the prosthetic heart valve.

15. The delivery device of claim 14, wherein the indicator includes a window in the frame having a series of increments, a critical indicator showing a position past which resheathing of the prosthetic heart valve is no longer possible, and a scrolling bar to illustrate the extent of deployment of the prosthetic heart valve.

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

an inner shaft;

a distal sheath disposed about a portion of the inner shaft and forming a compartment with the inner shaft, the compartment being adapted to receive the prosthetic heart valve, the inner shaft and the distal sheath being movable relative to one another; and

a handle including a frame having a longitudinal axis, a proximal end and a distal end, the handle further including a visual indicator disposed on the frame and capable of showing an extent of deployment of the prosthetic heart valve.

17. The delivery device of claim 16, wherein the indicator includes a window in the frame having a series of increments, a critical indicator showing a position past which resheathing of the prosthetic heart valve is no longer possible, and a scrolling bar to illustrate the extent of deployment of the prosthetic heart valve.

18. The delivery device of claim 16, further comprising a resheathing lock configured to alert a user of a predetermined position of the distal sheath and to impede movement of the distal sheath.