Retainers for transcatheter heart valve delivery systems

• US 9,439,795 B2
• Filed: 09/16/2011
• Issued: 09/13/2016
• 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, Glazier, Valerie J., Daly, Jacob John
• Primary Examiner(s): Manahan, Todd E
• Assistant Examiner(s): WEI, CHARLES M
• Application Number:
  US13/823,337
• Publication Number:
  US 20130289698A1
• Time in Patent Office: 1,824 Days
• Field of Search: 606/194, 606/198, 606/200, 623 111- 113, 623/1.15, 623/1.16, 623/1.2, 623/1.23, 623/1.24, 623/1.26, 623/2.1, 623/2.11
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube

Abstract

A delivery device 10 for a collapsible prosthetic heart valve includes a catheter assembly 16 including a shaft 26 around which a compartment 23 is defined, the compartment 23 being adapted to receive the valve in an assembled condition, and a retainer 30 including a pusher 32 and a holder 34 adapted to retain a stent portion 106 of the valve. The catheter assembly 16 also includes a distal sheath 24 adapted to selectively cover and uncover the compartment 23 and the valve, the distal sheath 24 extending around the shaft 26 at least when the distal sheath 24 covers the compartment 23. The pusher 32 includes one or more recesses 40 in a retention edge 33 thereof, each recess 40 being adapted to receive a junction 107 at an end of the stent portion 106 of the valve. The holder 34 includes one or more elongated ribs 50, each rib 50 being adapted to fit into a cell opening 108 of the stent portion 106 of the valve.

Claims

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

a catheter assembly including a principal shaft around which a compartment is defined, the compartment being adapted to receive the valve in an assembled condition, the catheter assembly further including a distal sheath adapted to selectively cover and uncover the compartment and the valve, the distal sheath extending around the principal shaft at least when the distal sheath covers the compartment, the principal shaft extending along a longitudinal axis of the delivery device extending in first and second opposite longitudinal directions; and

a retainer, including;

a pusher having at least one recess in a retention edge thereof, each recess being adapted to receive a corresponding junction at an end of a stent portion of the valve, each recess defining a portion of a lateral edge of the pusher that faces in the first longitudinal direction; and

a holder having at least one elongated rib adapted to fit into a cell opening in the stent portion of the valve, each rib having a portion of a lateral edge of the rib that faces in the second longitudinal direction,

wherein at least one of the pusher and the holder is slidable relative to another of the pusher and the holder along the longitudinal axis, and

wherein the pusher and the holder are adapted to pinch the junctions of the stent portion of the valve between the lateral edges of the pusher and the lateral edges of the ribs, the portion of the lateral edge of each recess of the pusher adapted to apply a first force to the corresponding junction in the first longitudinal direction, the portion of the lateral edge of each rib adapted to apply a second force to the corresponding junction in the second longitudinal direction.

2. The delivery device of claim 1, wherein the pusher is slidable relative to the holder along the longitudinal axis.

3. The delivery device of claim 1, wherein the holder is slidable relative to the pusher along the longitudinal axis.

4. The delivery device of claim 1, wherein the at least one recess is shaped to substantially match the shape of outward-facing surfaces of the junction.

5. The delivery device of claim 1, wherein the at least one rib has a width in a circumferential direction, an end of the rib relatively close to the pusher having a first width and an end of the rib relatively far from the pusher having a second width greater than the first width, such that the rib is shaped to substantially match the shape of inward-facing surfaces of the cell opening contacted by the rib.

6. The delivery device of claim 1, wherein the at least one rib has a cross-sectional shape in a circumferential direction that includes an undercut.

7. The delivery device of claim 1, wherein the at least one recess has a cross-sectional shape in a circumferential direction that includes an undercut.

8. The delivery device of claim 1, wherein the at least one recess is a continuous annular channel formed in the retention edge of the pusher adjacent a circumference of the pusher.

9. The delivery device of claim 1, wherein the principal shaft is fixedly connected to the holder, the delivery device further comprising a pusher shaft affixed to the pusher and extending along the longitudinal axis outside of the principal shaft.

10. The delivery device of claim 9, further comprising a locking pin adapted to temporarily affix the principal shaft to the pusher shaft so that the distal sheath is slidable along the longitudinal axis relative to the affixed principal shaft and pusher shaft.

11. The delivery device of claim 1, wherein the principal shaft is fixedly connected to the holder, the delivery device further comprising a pusher shaft affixed to the pusher and extending along the longitudinal axis inside of the principal shaft.

12. The delivery device of claim 11, further comprising a locking pin adapted to temporarily affix the principal shaft to the pusher shaft so that the distal sheath is slidable along the longitudinal axis relative to the affixed principal shaft and pusher shaft.

13. A method of delivering a collapsible prosthetic heart valve, the method comprising:

providing a delivery device including a principal shaft around which a compartment is defined, the principal shaft extending along a longitudinal axis of the delivery device extending in first and second opposite longitudinal directions, a distal sheath adapted to selectively cover and uncover the compartment, the distal sheath extending around the principal shaft at least when the distal sheath covers the compartment, and a retainer including a pusher and a holder, the pusher having at least one recess in a retention edge thereof, each recess defining a portion of a lateral edge of the pusher that faces in the first longitudinal direction, and the holder having at least one elongated rib, each rib having a portion of a lateral edge of the rib that faces in the second longitudinal direction;

mounting in the compartment a collapsible prosthetic heart valve having a stent portion including a plurality of junctions at an end thereof and a plurality of cell openings defined therein, the valve being mounted so that at least one of the junctions is positioned in the at least one recess and the at least one rib is positioned in at least one of the cell openings;

sliding at least one of the pusher and the holder towards another of the pusher and the holder, thereby pinching the junctions between the lateral edges of the pusher and the lateral edges of the ribs, the portion of the lateral edge of each recess applying a first force to the corresponding junction in the first longitudinal direction, the portion of the lateral edge of each rib applying a second force to the corresponding junction in the second longitudinal direction;

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

inserting the delivery device in a patient to position the valve at a target location; and

deploying the valve by moving the distal sheath to uncover the compartment and the valve.

14. The method of claim 13, wherein the principal shaft is fixedly connected affixed to the holder, and the pusher is fixedly connected to a pusher shaft, the sliding step including sliding at least one of the principal shaft and the pusher shaft relative to another of the principal shaft and the holder shaft.

15. The method of claim 13, further comprising, after the sliding step, temporarily fixing the position of the pusher relative to the holder.

16. The method of claim 15, further comprising, after the inserting step, releasing at least one of the pusher and the holder for movement relative to one another.

17. The method of claim 16, further comprising sliding at least one of the pusher and the holder away from another of the pusher and the holder, thereby releasing the junctions positioned therebetween.