Retainers for transcatheter heart valve delivery systems

• US 10,660,752 B2
• Filed: 03/15/2018
• Issued: 05/26/2020
• Est. Priority Date: 03/16/2017
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Inventors: Klima, Daniel J., Morrissey, Michael Shane
• Primary Examiner(s): Ulsh, George J
• Application Number:
  US15/921,759
• Publication Number:
  US 20180263772A1
• Time in Patent Office: 803 Days
• Field of Search: 623 211
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• 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 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2002/9665 with additional retaining means

Abstract

A delivery device for an implantable medical device includes an inner shaft extending in a longitudinal direction and an outer sheath adapted to surround at least a portion of the inner shaft, the outer sheath being slideable relative to the inner shaft in the longitudinal direction. A compartment defined between the inner shaft and the outer sheath is adapted to receive the medical device in an assembled condition. A retaining assembly positioned at one end of the compartment includes a first member rotatable with respect to the inner shaft, and a second member rotationally fixed with respect to the inner shaft. The medical device includes at least one retainer adapted to be received within at least one retainer slot of the first member. This arrangement enables the medical device to rotate within the compartment as the delivery device is advanced to an implantation site.

Claims

1. A delivery device for an implantable medical device having at least one retainer thereon, the delivery device comprising:

an inner shaft extending in a longitudinal direction;

an outer sheath adapted to surround at least a portion of the inner shaft, the outer sheath being slideable relative to the inner shaft in the longitudinal direction;

a compartment defined between the inner shaft and the outer sheath and adapted to receive the medical device in an assembled condition;

a retaining assembly positioned at one end of the compartment, the retaining assembly including a first member rotatable with respect to the inner shaft, and a second member rotationally fixed with respect to the inner shaft; and

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

wherein engagement between the first member and the second member limits rotation of the first member.

2. The delivery device of claim 1, wherein the second member includes an arcuate slot and the first member includes an arcuate flange received within the arcuate slot.

3. The delivery device of claim 2, wherein the arcuate flange includes first and second terminal ends and the second member includes at least one extension at least partially defining the arcuate slot.

4. The delivery device of claim 3, wherein the at least one extension includes a first extension and a second extension, the first member being configured to rotate between a first position in which the first terminal end contacts the first extension and a second position in which the second terminal end contacts the second extension, a maximum range of rotation of the first member being defined by the first position and the second position.

5. The delivery device of claim 4, wherein the maximum range of rotation is between 0 degrees and 90 degrees.

6. The delivery device of claim 1, wherein the first member includes a first rim having a plurality of first teeth extending along a circumference thereof, and the second member includes a second rim having a plurality of second teeth extending along a circumference thereof.

7. The delivery device of claim 6, wherein the plurality of first teeth are in ratcheting engagement with the plurality of second teeth so that the first member is capable of rotation about the inner shaft in a first direction but substantially incapable of rotating about the inner shaft in a second direction opposite the first direction.

8. The delivery device of claim 7, wherein the first member is capable of unlimited rotation about the inner shaft in the first direction.

9. A system for delivering a medical device to a patient, the system comprising:

the delivery device of claim 1; and

the medical device.

10. The system of claim 9, wherein the medical device is a collapsible prosthetic heart valve including a valve assembly mounted within a stent, the stent including a plurality of retainers and the first member including a plurality of retainer slots, each of the retainers being receivable within a corresponding one of the retainer slots.

11. The system of claim 10, wherein the prosthetic heart valve extends from an inflow end to an outflow end, the plurality of retainers being positioned on the outflow end of the prosthetic valve.

12. A method of delivering a collapsible prosthetic valve to a patient comprising:

providing the collapsible prosthetic valve having a collapsible valve assembly mounted within a collapsible stent, the stent having a plurality of retainers extending therefrom;

providing a delivery device including;

an inner shaft extending in a longitudinal direction;

an outer sheath adapted to surround at least a portion of the inner shaft;

a compartment defined between the inner shaft and the outer sheath; and

a retaining assembly positioned at one end of the compartment, the retaining assembly including a first member rotatable with respect to the inner shaft and a second member rotationally fixed with respect to the inner shaft;

loading the collapsible prosthetic valve into the compartment in a collapsed condition so that the retainers are received within corresponding retainer slots of the first member;

advancing the compartment to a site of implantation in the patient;

rotating the first member relative to the second member during the advancing step, wherein engagement between the first member and the second member limits rotation of the first member; and

exposing the compartment by sliding the outer sheath relative to the inner shaft so that the collapsible prosthetic valve at least partially expands.

13. The method of claim 12, wherein the rotating step includes rotating an arcuate flange of the first member within an arcuate slot of the second member.

14. The method of claim 13, wherein the arcuate flange includes first and second terminal ends and the second member includes at least one extension at least partially defining the arcuate slot.

15. The method of claim 14, wherein the at least one extension includes a first extension and a second extension, and the rotating step includes rotating the first member between a first position in which the first terminal end contacts the first extension and a second position in which the second terminal end contacts the second extension, the first member having a maximum range of rotation defined by the first position and the second position.

16. The method of claim 15, wherein the loading step includes loading the collapsible prosthetic valve into the compartment so that the first terminal end is a spaced distance from the first extension and the second terminal end is a spaced distance from the second extension.

17. The method of claim 12, wherein during the advancing step, a plurality of first teeth extending along a circumference of a first rim of the first member are engaged with a plurality of second teeth extending from a circumference of a second rim of the second member.

18. The method of claim 17, wherein during the advancing step, the plurality of first teeth are in ratcheting engagement with the plurality of second teeth so that the first member rotatable with respect to the inner shaft in a first direction but substantially incapable of rotating with respect to the inner shaft in a second direction opposite the first direction.

19. The method of claim 12, further comprising allowing forces exerted upon the prosthetic valve to cause the first member to rotate with respect to the inner shaft and relative to the second member while the compartment is within the patient.

20. The method of claim 12, further comprising manually rotating the delivery device to cause both the first member and the second member to rotate about a longitudinal axis extending from a proximal end of the retaining assembly to a distal end of the retaining assembly while the compartment is within the patient.