PREPARATION METHODS FOR TRANSCATHETER HEART VALVE DELIVERY SYSTEMS

• US 20120083876A1
• Filed: 09/16/2011
• Published: 04/05/2012
• Est. Priority Date: 09/17/2010
• 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: Wang, Huisun
• Granted Patent: US 8,721,715 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• 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 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod

Abstract

A delivery device for a collapsible prosthetic heart valve includes a support shaft around which a compartment is defined, an inner shaft extending through the support shaft and adapted to slide relative to the support shaft along a longitudinal axis thereof, the inner shaft having a lumen therethrough, and a distal sheath operatively connected at a distal end to the inner shaft and slidable therewith. The compartment may receive the valve in an assembled condition, and may be selectively covered and uncovered by the distal sheath. A first flow path may provide flow communication between the lumen of the inner shaft and the compartment.

Claims

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

a support shaft around which a compartment is defined, the compartment being adapted to receive the valve in an assembled condition;

an inner shaft extending through the support shaft and adapted to slide relative to the support shaft along a longitudinal axis thereof, the inner shaft having a lumen there through;

a distal sheath operatively connected at a distal end to the inner shaft and slidable therewith, the distal sheath being adapted to selectively cover and uncover the compartment and the valve; and

a first flow path providing flow communication between the lumen of the inner shaft and the compartment.

2. The delivery device of claim 1, further comprising:

a distal tip operatively connected to a distal end of the inner shaft;

a distal retainer interposed between the distal tip and the compartment; and

a pocket defined between the distal retainer and the distal tip.

3. The delivery device of claim 2, further comprising a second flow path providing flow communication between the pocket and the compartment.

4. The delivery device of claim 3, wherein the second flow path includes at least one through-hole in the distal retainer.

5. The delivery device of claim 2, wherein the first flow path includes an aperture in a wall of the inner shaft providing flow communication between the lumen of the inner shaft and the pocket.

6. The delivery device of claim 2, further comprising an insert disposed in the pocket and defining an empty space between the insert and the distal tip, the empty space being in flow communication with the lumen of the inner shaft, the insert including one or more liquid passages extending between the empty space and the pocket.

7. The delivery device of claim 1, further comprising:

a proximal retainer located at a proximal end of the compartment; and

a cylindrical gap defined between a free end of the distal sheath and the proximal retainer.

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

a support shaft around which a compartment is defined, the compartment being adapted to receive the valve in an assembled condition;

an inner shaft extending through the support shaft and adapted to slide relative to the support shaft along a longitudinal axis thereof, the inner shaft having a lumen there through;

a distal sheath having a distal end operatively connected to the inner shaft and slidable therewith, the distal sheath being adapted to selectively cover and uncover the compartment and the valve; and

a distal tip operatively connected to a distal end of the inner shaft, the distal tip having a passage therein providing flow communication between an exterior of the delivery device and the compartment.

9. The delivery device of claim 8, wherein the passage is adapted to self-seal such that liquid can not flow therethrough from the compartment to the exterior of the delivery device.

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

a support shaft around which a compartment is defined, the compartment being adapted to receive the valve in an assembled condition;

an inner shaft extending through the support shaft and adapted to slide relative to the support shaft along a longitudinal axis thereof, the inner shaft having a lumen therethrough in flow communication with an exterior of the delivery device;

a distal sheath operatively connected at a distal end to the inner shaft and slidable therewith, the distal sheath being adapted to selectively cover and uncover the compartment and the valve;

a first flow path providing flow communication between the lumen of the inner shaft and the compartment; and

a removable plug adapted for connection to the delivery device to occlude the flow communication between the lumen of the inner shaft and the exterior of the delivery device.

11. The delivery system of claim 10, further comprising a removable cap adapted for connection to a proximal end of the inner shaft to create a liquid-tight seal at the proximal end of the inner shaft.

12. The delivery system of claim 10, further comprising:

a distal tip operatively connected to a distal end of the inner shaft; and

a flushing needle having a hollow needle shaft adapted to supply a flushing liquid to the compartment through the distal tip.

13. The delivery system of claim 10, further comprising:

a distal tip operatively connected to a distal end of the inner shaft;

a distal retainer interposed between the distal tip and the compartment; and

a pocket defined between the distal retainer and the distal tip.

14. The delivery system of claim 13, further comprising a second flow path providing flow communication between the pocket and the compartment.

15. The delivery system of claim 14, wherein the second flow path includes at least one through-hole in the distal retainer.

16. The delivery system of claim 13, wherein the first flow path includes an aperture in a wall of the inner shaft providing flow communication between the lumen of the inner shaft and the pocket.

17. The delivery system of claim 13, further comprising an insert disposed in the pocket and defining an empty space between the insert and the distal tip, the empty space being in flow communication with the lumen of the inner shaft, the insert including one or more liquid passages extending between the empty space and the pocket.

18. A method of flushing a delivery device for a collapsible prosthetic heart valve, the method comprising:

providing a delivery device including a support shaft around which a compartment is defined, an inner shaft extending through the support shaft and adapted to slide relative to the support shaft along a longitudinal axis thereof, and a distal sheath having a distal end operatively connected to the inner shaft and a proximal end, the distal sheath being slidable with the inner shaft;

mounting a collapsible prosthetic heart valve in the compartment;

sliding the distal sheath to cover the compartment and the valve; and

flushing a liquid through the compartment from a distal end of the compartment to a proximal end of the compartment.

19. The method of claim 18, wherein the flushing step includes flowing the liquid out of the compartment through an opening at the proximal end of the distal sheath.

20. The method of claim 18, wherein the flushing step includes flowing the liquid through a lumen in the inner shaft in a direction from a proximal end of the inner shaft toward a distal end of the inner shaft, and flowing the liquid from the lumen of the inner shaft to the compartment.

21. The method of claim 20, wherein the flushing step includes flowing the liquid from the lumen of the inner shaft to the compartment through an aperture in a wall of the inner shaft.

22. The method of claim 20, wherein the delivery device further includes a distal tip operatively connected to the distal end of the inner shaft, a distal retainer interposed between the distal tip and the compartment, a pocket defined between the distal retainer and the distal tip, and an insert disposed in the pocket and defining an empty space between the insert and the distal tip, and the flushing step includes flowing the liquid from the lumen of the inner shaft to the empty space, from the empty space through the insert to the pocket, and from the pocket through the distal retainer to the compartment.

23. The method of claim 18, wherein the flushing step includes flowing the liquid through a lumen in the inner shaft in a direction from a distal end of the inner shaft toward a proximal end of the inner shaft, and flowing the liquid from the lumen of the inner shaft to the compartment.

24. The method of claim 18, wherein the delivery device further includes a distal tip operatively connected to a distal end of the inner shaft, the distal tip having a passage therein, and the flushing step includes flowing the liquid through the passage into the distal end of the compartment.