Retainers for transcatheter heart valve delivery systems

• US 9,119,717 B2
• Filed: 07/12/2011
• Issued: 09/01/2015
• Est. Priority Date: 07/15/2010
• Status: Active Grant

• Current Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Inventors: Wang, Huisun, Glazier, Valerie J., Grafov, Alex
• Primary Examiner(s): Woo, Julian W
• Assistant Examiner(s): David, Shaun L
• Application Number:
  US13/180,720
• Publication Number:
  US 20120078350A1
• Time in Patent Office: 1,512 Days
• Field of Search: 623/2.11, 623 111- 112, 606/118
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• 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 2002/9665 with additional retaining means

Abstract

A delivery device for an implantable medical device having at least one retention member at an end thereof includes a shaft extending in a longitudinal direction, an elongated sheath surrounding a longitudinal portion of the shaft, a compartment defined inside of the sheath and adapted to receive the medical device in an assembled condition, a retainer positioned at one end of the compartment, and at least one acceptance in the retainer adapted to receive the retention member of the medical device in the assembled condition. The sheath is slidable relative to the shaft in the longitudinal direction to uncover and deploy the medical device. The retainer may be rotatable relative to the shaft to reduce torsional forces in the medical device during delivery and deployment. The retainer may have at least one recess facing the compartment for receiving a strut at an end of a stent of the medical device.

Claims

1. A delivery device for an implantable medical device having at least one retention member at an end thereof, the delivery device comprising:

a shaft extending in a longitudinal direction;

an elongated sheath surrounding a longitudinal portion of the shaft, the sheath being slidable relative to the shaft in the longitudinal direction;

a compartment defined inside of the sheath and adapted to receive the medical device in an assembled condition;

a retainer positioned at one end of the compartment, the retainer including an inner piece and an outer piece mounted on the inner piece so as to be rotatable about the inner piece and constrained from movement relative to the inner piece in the longitudinal direction; and

at least one acceptance in the retainer adapted to receive the retention member of the medical device in the assembled condition,

wherein the outer piece has a retention edge facing the compartment and the acceptance has a first region sized to receive the retention member, the acceptance including at least one protuberance defining a narrowed neck between the first region and the retention edge.

2. The delivery device of claim 1, wherein one of the outer piece and the inner piece includes a circumferentially extending groove and another of the outer piece and the inner piece includes an annular ring assembled in the groove and permitting the outer piece to rotate about the inner piece.

3. The delivery device of claim 2, wherein the retainer further includes a support piece mounted on the inner piece and fixedly connected to the outer piece, whereby the outer piece and the support piece are rotatable together about the inner piece.

4. The delivery device of claim 1, wherein the medical device includes a self-expanding stent having a plurality of struts and the outer piece has a retention edge facing the compartment and at least one recess extending in the longitudinal direction from an open end at the retention edge to a closed end, the recess being adapted to receive one of the plurality of struts at an end of the stent in the assembled condition.

5. The delivery device of claim 4, wherein the acceptance has a length in the longitudinal direction such that in the assembled condition the one of the plurality of struts contacts the closed end of the recess while the retention member is spaced from a closed end of the acceptance.

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

a pin extending radially outward from the at least one acceptance, the pin being adapted to engage an aperture in the retention member; and

an actuator coupled to the pin and adapted to move the pin in the longitudinal direction, thereby adjusting the longitudinal position of the retention member relative to the acceptance.

7. The delivery device of claim 1, wherein the medical device is a self-expanding collapsible prosthetic valve.

8. A system for implantable medical device delivery, the system comprising:

a delivery device including

a shaft extending in a longitudinal direction;

an elongated sheath surrounding a longitudinal portion of the shaft, the sheath being slidable relative to the shaft in the longitudinal direction;

a compartment defined inside of the sheath;

a retainer positioned at one end of the compartment, the retainer including an inner piece and an outer piece mounted on the inner piece so as to be rotatable about the inner piece and constrained from movement relative to the inner piece in the longitudinal direction; and

at least one acceptance in the retainer; and

an implantable medical device assembled in the compartment, the medical device having at least one retention member at an end thereof, the retention member being positioned in the acceptance,

wherein the outer piece has a retention edge facing the compartment and the acceptance has a first region sized to receive the retention member, the acceptance including at least one protuberance defining a narrowed neck between the first region and the retention edge.

9. The system of claim 8, wherein one of the outer piece and the inner piece includes a circumferentially extending groove and another of the outer piece and the inner piece includes an annular ring assembled in the groove and permitting the outer piece to rotate about the inner piece.

10. The system of claim 9, wherein the retainer further includes a support piece mounted on the inner piece and fixedly connected to the outer piece, whereby the outer piece and the support piece are rotatable together about the inner piece.

11. The system of claim 8, wherein the medical device includes a self-expanding stent having a plurality of struts and the outer piece has a retention edge facing the compartment and at least one recess extending in the longitudinal direction from an open end at the retention edge to a closed end, one of the plurality of struts at an end of the stent being assembled in the recess.

12. The system of claim 11, wherein the acceptance has a length in the longitudinal direction such that the one of the plurality of struts contacts the closed end of the recess while the retention member is spaced from a closed end of the acceptance.

13. The system of claim 8, further comprising:

a pin extending radially outward from the at least one acceptance and engaged in an aperture in the retention member; and

an actuator coupled to the pin and adapted to move the pin in the longitudinal direction, thereby adjusting the longitudinal position of the retention member relative to the acceptance.

14. The system of claim 8, wherein the medical device is a self-expanding collapsible prosthetic valve.

15. A delivery device for an implantable medical device including a self-expanding stent having a plurality of struts and at least one retention member at an end of the stent, the delivery device comprising:

a shaft extending in a longitudinal direction;

an elongated sheath surrounding a longitudinal portion of the shaft, the sheath being slidable relative to the shaft in the longitudinal direction;

a compartment defined inside of the sheath and adapted to receive the medical device in an assembled condition;

a retainer positioned at one end of the compartment, the retainer having a retention edge facing the compartment;

at least one acceptance in the retainer adapted to receive the retention member of the medical device in the assembled condition, the acceptance extending in the longitudinal direction from an open end at the retention edge to a closed end facing in a first direction towards the compartment, the acceptance having a length in the longitudinal direction such that in the assembled condition the length of the acceptance is greater than a length of the retention member in the longitudinal direction; and

at least one recess in the retainer, the recess adapted to receive one of the plurality of struts at the end of the stent of the medical device in the assembled condition, the recess extending in the longitudinal direction from an open end at the retention edge to a closed end facing in the first direction towards the compartment,

wherein in the assembled condition the one of the plurality of struts contacts the closed end of the recess while the retention member is spaced from the closed end of the acceptance, the closed end of the recess located a first distance from the retention edge in the longitudinal direction, the closed end of the acceptance located a second distance from the retention edge in the longitudinal direction, the second distance being greater than the first distance.

16. The delivery device of claim 15, wherein the acceptance has a first region sized to receive the retention member, the acceptance including at least one protuberance defining a narrowed neck between the first region and the retention edge.

17. The delivery device of claim 15, further comprising the implantable medical device disposed in the compartment in the assembled condition.

18. The delivery device of claim 17, wherein the medical device is a self-expanding collapsible prosthetic valve.

19. The delivery device of claim 17, further comprising:

a pin extending radially outward from the at least one acceptance, the pin being adapted to engage an aperture in the retention member; and

an actuator coupled to the pin and adapted to move the pin in the longitudinal direction, thereby adjusting the longitudinal position of the retention member relative to the acceptance.