STENTED PROSTHETIC HEART VALVE DELIVERY SYSTEM HAVING AN EXPANDABLE BUMPER

• US 20180098848A1
• Filed: 10/12/2016
• Published: 04/12/2018
• Est. Priority Date: 10/12/2016
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Tran, Don, Barajas-Torres, Martha, Mitchell, James, Mendoza, Leonel, Som, Siyan, Mendelson, Jill, Grossman, David
• Granted Patent: US 11,426,276 B2
• Time in Patent Office: Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath

Abstract

Delivery devices for delivery of a stented prosthetic heart valve. Various delivery devices include an outer sheath assembly including an outer sheath connected to a capsule that is advanced proximally to retain the prosthetic valve, which is secured over an inner shaft assembly of the delivery device. The delivery device further includes a bumper to provide a smooth transition of the capsule over the prosthetic valve during loading and recapture procedures. The bumper is expandable from a first position to a second position in which a distal end of the bumper is expanded to increase its diameter. The bumper can be biased in the second, expanded position so that the bumper automatically transitions to the expanded position upon retraction of the outer sheath.

Claims

1. A delivery device for delivering a stented prosthetic heart valve to a native heart valve;

the delivery device comprising;

an inner shaft assembly configured to retain the stented prosthetic heart valve;

a bumper secured to the inner shaft assembly so that the inner shaft assembly extends through a cavity defined by the bumper, the bumper having a distal end, a proximal end and an outer surface;

wherein the bumper has a compressed position and an expanded position; and

an outer sheath assembly slidably positioned over at least part of the inner shaft assembly;

the outer sheath assembly configured to slide distally and proximally over the bumper to sheathe and unsheathe the stented prosthetic heart valve.

2. The delivery device of claim 1, when in the expanded position, the outer surface further includes a ramped surface having an increasing outer diameter.

3. The delivery device of claim 1, wherein the outer sheath assembly includes a capsule having an inner diameter and further wherein a greatest outer diameter of the distal end in the expanded position is larger than the inner diameter of the capsule.

4. The delivery device of claim 1, wherein the distal end of the bumper includes a plurality of longitudinally extending cuts.

5. The delivery device of claim 4, wherein the distal end of the bumper includes a plurality of petals separated by the cuts.

6. The delivery device of claim 5, wherein the petals are pivotable about the proximal end.

7. The delivery device of claim 1, wherein transition of the bumper from the compressed position to the expanded position is actuated by movement of the outer sheath assembly.

8. The delivery device of claim 1, wherein the distal end of the bumper is biased in the expanded position.

9. The delivery device of claim 1, wherein the outer sheath assembly includes an outer sheath connected to a capsule and further wherein the bumper can be positioned entirely within the outer sheath of the outer sheath assembly.

10. The delivery device of claim 1, wherein in the compressed position, the bumper is generally cylindrical.

11. The delivery device of claim 1, wherein the bumper is constructed of a unitary piece of material.

12. A method of recapturing a prosthetic heart valve;

the method comprising the steps of;

providing a delivery device having the prosthetic heart valve loaded thereto;

wherein the delivery device includes an outer sheath assembly positioned at least partially over an inner shaft assembly and a bumper located proximal to the loaded prosthetic heart valve;

delivering a prosthetic heart valve to a location in a patient'"'"'s body;

proximally retracting the outer sheath assembly in a direction proximal to the prosthetic heart valve such that at least a portion of the bumper increases in diameter;

at least partially deploying the prosthetic heart valve; and

distally advancing the outer sheath assembly over the bumper and over at least part of the partially deployed prosthetic heart valve.

13. The method of claim 12, wherein the outer sheath assembly includes a capsule in which the prosthetic heart valve is loaded when in the loaded during the step of delivering the prosthetic heart valve.

14. The method of claim 13, wherein the capsule has an inner diameter and wherein during the step of distally advancing the outer sheath assembly, a distal end of the bumper is in an expanded position and defines a greatest expanded diameter;

wherein the greatest expanded diameter is larger than the inner diameter of the capsule.

15. The method of claim 12, wherein the outer sheath assembly includes an outer sheath connected to a capsule;

wherein the bumper is positioned entirely within the outer sheath during the step of delivering the prosthetic heart valve.

16. The method of claim 12, wherein a distal end of the bumper includes a plurality of petals.

17. The method of claim 16, wherein the plurality of petals pivot about a proximal end of the bumper as the outer sheath is proximally retracted.

18. The method of claim 12, wherein at least a portion of the bumper increases in diameter by transitioning to include a ramped surface.