System and Method of Stepped Deployment of Prosthetic Heart Valve

摘要

A system for replacing a heart valve of a patient. The system includes a delivery device and a prosthetic heart valve. The system is configured to be transitionable between a loaded state, a partially deployed state and a deployed state. In the loaded state, the prosthetic heart valve engages a coupling structure and is compressively retained within a primary capsule, which constrains the prosthetic heart valve in a compressed arrangement. In the partially deployed state, the prosthetic heart valve engages the coupling structure and is compressively retained within a secondary capsule, which constrains the prosthetic heart valve to a partially deployed arrangement. The partially deployed arrangement is less compressed than the compressed arrangement and less expanded than a deployed arrangement. In the deployed state, the primary and secondary capsules are retracted from over the prosthetic heart valve, which expands to the deployed arrangement and is released from the coupling structure.

主权项

1. A system for replacing a heart valve of a patient, the system comprising:
a delivery device comprising:
an inner shaft assembly including an intermediate portion providing a coupling structure,a primary capsule slidably disposed over the inner shaft assembly, anda secondary capsule slidably disposed over the inner shaft assembly; and a prosthetic heart valve having a stent frame and a valve structure attached to the stent frame, the prosthetic heart valve being expandable from compressed arrangements to expanded arrangements; wherein the system is configured to be transitionable between:
a loaded state in which the prosthetic heart valve engages the coupling structure and is compressively retained within the primary capsule, the primary capsule constraining the prosthetic heart valve in a compressed arrangement,a partially deployed state in which the prosthetic heart valve engages the coupling structure and is compressively retained within the secondary capsule, the partially deployed state including the primary capsule at least partially retracted from over the prosthetic heart valve and the secondary capsule at least partially constraining the prosthetic heart valve to a partially deployed arrangement, the partially deployed arrangement being less compressed than the compressed arrangement and less expanded than a deployed arrangement,a deployed state in which the primary and secondary capsules are refracted from over the prosthetic heart valve and the prosthetic heart valve is expanded to the deployed arrangement and released from the coupling structure.