Transcatheter prosthetic heart valve delivery system and method with controlled expansion of prosthetic heart valve

摘要

A delivery system for use with a prosthetic heart valve having a stent frame to which a valve structure is attached includes a shaft assembly including a distal end, an intermediate portion, and a first coupling structure disposed near the distal end and configured to be coupled to a distal end of the prosthetic heart valve via a first tether. A sheath assembly defines a lumen sized to slidably receive the shaft assembly. The delivery system is configured to transition from a loaded state in which the sheath assembly encompasses the prosthetic heart valve to a deployed state in which the sheath assembly is withdrawn from the prosthetic heart valve. The first coupling structure is configured to be manipulated in a first direction to provide a controlled expansion or contraction of the distal end of the prosthetic heart valve.

主权项

1. A method of performing a therapeutic procedure on a defective heart valve of a patient, the method comprising:
receiving a delivery system loaded with a self-expanding prosthetic heart valve having a stent frame to which a valve structure is attached, the delivery system including a shaft assembly slidably positioned within a delivery sheath, the shaft assembly including a first coupling structure disposed near a distal end of the shaft assembly and coupled to a distal end of the prosthetic heart valve via a first tether, the delivery sheath containing the prosthetic heart valve in a compressed arrangement; manipulating the delivery system to guide the prosthetic heart valve through the patient's vasculature and into the defective heart valve; withdrawing the delivery sheath from the prosthetic heart valve to a partially retracted state in which an entirety of a distal region of the prosthetic heart valve is exposed and an entirety of a proximal region of the prosthetic heart valve is contained within the delivery sheath; manipulating the first coupling structure in a first direction to provide a controlled expansion of the distal end of the prosthetic heart valve while in the partially retracted state; and releasing the prosthetic heart valve from the delivery system.